biopharma

biopharma https://biospectrumindia.com/rssfeed/pharma/biopharma biopharma <![CDATA[Novo India introduces 35% price reduction for Norditropin® FlexPro® to expand affordable access to Growth Hormone Therapy]]> https://biospectrumindia.com/news/95/28656/novo-india-introduces-35-price-reduction-for-norditropin-flexpro-to-expand-affordable-access-to-growth-hormone-therapy.html https://biospectrumindia.com/news/95/28656/novo-india-introduces-35-price-reduction-for-norditropin-flexpro-to-expand-affordable-access-to-growth-hormone-therapy.html Thu, 15 Oct 2026 13:49:03 +0530 Novo India has introduced a significant price reduction of upto 35% for Norditropin® FlexPro® for adults & children living with growth hormone deficiency in India. Effective today, this innovative growth hormone therapy will be available with a new India-specific pricing in two dose strengths - 10 mg & 15 mg. The price of the 10mg device has been reduced by 33%, from Rs 16,836 to Rs 11,300, while for 15mg device price has been reduced by 35%, from Rs 25,254 to Rs 16,450 — translating to savings of Rs 5,539 and Rs 8,802 per pen, respectively. This significant step is part of Novo's continued commitment to expanding access and affordability to essential therapies for people living with growth hormone deficiency and related conditions across India. Vikrant Shrotriya, Managing Director, Novo India said, "Growth hormone deficiency is a rare endocrine disorder, with published estimates suggesting it affects approximately 1 in 4,000 to 1 in 10,000 children. At Novo India, we are committed to deliver innovation and ensure that every child living with growth hormone deficiency has access to the therapy they need. This price reduction is a direct reflection of that commitment and reinforces our long-term focus on enabling life-changing treatment to reach children and families across India." Growth hormone deficiency occurs when the pituitary gland does not produce enough growth hormone to support normal growth. The deficiency may be present from birth or develop later, with causes including genetic or structural abnormalities and damage to the pituitary region; in many children, no specific cause is identified. Norditropin® FlexPro® is a pre-filled, easy-to-use growth hormone pen designed for children requiring long-term therapy. The device is designed to support ease of use and adherence for youngsters and their caregivers managing a long-term treatment journey. ]]> <![CDATA[Biocon secures earliest licensed launch dates for Pebrilzo® (bPertuzumab) following global patent settlement with Genentech]]> https://biospectrumindia.com/news/95/28646/biocon-secures-earliest-licensed-launch-dates-for-pebrilzo-bpertuzumab-following-global-patent-settlement-with-genentech.html https://biospectrumindia.com/news/95/28646/biocon-secures-earliest-licensed-launch-dates-for-pebrilzo-bpertuzumab-following-global-patent-settlement-with-genentech.html Wed, 14 Oct 2026 13:13:16 +0530 Biocon has entered into a global settlement and license agreement with Genentech, securing earliest licensed launch dates for Pebrilzo®, its biosimilar to the reference product Perjeta® (Pertuzumab). Biocon and Genentech executed the patent settlement agreement to resolve all pending disputes between the companies, including in the US, Canada, and other jurisdictions. This global patent settlement and license agreement enables Biocon to launch Pebrilzo® in Q1 of calendar year (CY) 2027 in the European Union and UK, Q3 of CY 2028 in the U.S., and in CY 2026-2028 in other Rest of the World (RoW) countries or earlier in certain circumstances. Pebrilzo® is a biosimilar medicinal product and the active substance is Pertuzumab, a monoclonal antibody that binds with high affinity and specificity to the human epidermal growth factor receptor 2 (HER2), inhibiting the proliferation of tumour cells that overexpress HER2. Pebrilzo® is used for the treatment of HER2-positive breast cancer across multiple disease stages. ]]> <![CDATA[Montana’s ‘Right to Try’ model could open US market access for Indian biopharma companies: Steve Eror]]> https://biospectrumindia.com/news/95/28617/montanas-right-to-try-model-could-open-us-market-access-for-indian-biopharma-companies-steve-eror.html https://biospectrumindia.com/news/95/28617/montanas-right-to-try-model-could-open-us-market-access-for-indian-biopharma-companies-steve-eror.html Thu, 08 Oct 2026 18:04:50 +0530 Montana could provide Indian biotechnology and biopharma companies with an alternative pathway to reach US patients, generate clinical experience and build data while progressing towards wider regulatory approval, said Steve Eror, President, Montana Bioscience Alliance and CEO, Solo-Dex. Speaking at the CXO-level roundtable facilitated by the Association of Biotechnology Led Enterprises (ABLE) during Montana Governor Greg Gianforte’s India visit to Bengaluru on October 7, Eror outlined Montana’s experimental treatment and Right to Try framework, which he said could be particularly relevant for emerging therapies, personalised medicine and advanced treatments. Eror said the objective was to bring together India’s capabilities in pharmaceutical and medical-device manufacturing with the US market and create a faster route for companies to begin working with patients. From clinical development to patient access According to Eror, Montana’s framework allows eligible patients to access experimental treatments after Phase I data has established an appropriate safety basis, subject to review by an independent board of medical professionals. He contrasted this with the conventional compassionate-use pathway, which he said can involve significant regulatory requirements and delays. Under Montana’s model, he said, companies can potentially treat patients while collecting real-world information that can contribute to subsequent clinical development. “The idea that you can get your Phase I data in India, present it to a board of five individuals, and they agree that you can go ahead and treat them, gives you an opportunity to move forward with that patient right away,” Eror said. He stressed, however, that the model does not guarantee efficacy. The treatment must have sufficient safety data, while patients and treating institutions remain part of the decision-making process. Opportunity for Indian developers Eror said the framework could be relevant to companies developing therapies that are still progressing through the conventional regulatory pathway, particularly where patients have limited treatment options. He pointed to CAR-T and personalised medicine as areas where the model could potentially have significant applications. For Indian companies, he argued that the opportunity extends beyond patient access. Data generated through treatment could support subsequent clinical-development programmes, while companies could potentially generate revenue from treatment before achieving broader market approval. “The US is open,” he said, encouraging Indian developers to consider Montana as a potential entry point into the US market. Destination medicine model Responding to a question on how an Indian company could operationalise such a programme while retaining its core infrastructure in India, Eror said Montana could operate as a destination-medicine model. Under the approach described at the roundtable, a patient could travel to Montana, receive treatment at a participating clinic and have relevant data collected. The manufacturer would then receive the data, subject to patient privacy requirements, for use in its ongoing development programme. Eror said this could allow companies to generate clinical experience and revenue while continuing to work towards the regulatory approvals required for broader commercialisation in the US. He also indicated that Montana’s approach could have applications beyond conventional pharmaceutical products, depending on the regulatory requirements and the nature of the product. Montana Bioscience Alliance as a facilitator Eror said the Montana Bioscience Alliance, a consortium of companies, could help companies explore the opportunity and navigate the emerging ecosystem. He positioned the initiative as part of a broader effort to make Montana a destination for innovative therapies and personalised medicine, while also helping biotechnology companies access the US market. The presentation underscored a potential area of India–Montana collaboration: combining India’s biotechnology, pharmaceutical and medical-device capabilities with Montana’s regulatory environment, clinical infrastructure and access to the US market.   Narayan Kulkarni narayan.kulkarni@mmactiv.com ]]> <![CDATA[Montana pitches low-cost, business-friendly ecosystem to Indian life-sciences companies]]> https://biospectrumindia.com/news/95/28618/montana-pitches-low-cost-business-friendly-ecosystem-to-indian-life-sciences-companies.html https://biospectrumindia.com/news/95/28618/montana-pitches-low-cost-business-friendly-ecosystem-to-indian-life-sciences-companies.html Thu, 08 Oct 2026 18:17:00 +0530 Montana is positioning itself as a business-friendly destination for Indian companies looking to establish a US presence, with advantages spanning talent, operating costs, taxation, infrastructure and access to the Western US and Canadian markets, said Frederick Van Den Abbeel, Senior Business Attraction Advisor, Montana Department of Commerce. Speaking at the CXO-level roundtable facilitated by the Association of Biotechnology Led Enterprises (ABLE) during Montana Governor Greg Gianforte’s India visit on October 7, Van Den Abbeel highlighted Montana’s location, workforce and business environment as key advantages for Indian companies evaluating expansion into the US. He said Montana’s central location makes it particularly relevant for companies seeking to serve the Western United States and Western Canada, including California, while potentially avoiding the higher operating costs associated with some larger US states. “Capital goes where it is welcome and stays where it is well-treated,” Van Den Abbeel said, describing this as a core philosophy underpinning Montana’s approach to business. Talent and STEM strength Van Den Abbeel placed workforce capabilities at the centre of Montana’s proposition. He noted that Indian students represent the second-largest international student population in Montana’s public universities, describing this as an area with potential for further academic exchange between India and Montana. He also highlighted Montana’s strong STEM education base and apprenticeship programmes, particularly for industries that require technically trained employees. According to him, Montana has a high school graduation rate and a strong ranking in STEM education compared with several larger US states. For Indian manufacturers and life-sciences companies, he said, access to skilled employees, combined with apprenticeship-based workforce development, could support expansion and manufacturing operations. Lower operating costs Van Den Abbeel also emphasised Montana’s operating-cost advantages. He pointed to competitive industrial electricity rates, saying they are below the US average, and highlighted the state’s business tax environment and financial performance. He further cited Montana’s business survival rate and its ranking as an attractive state for establishing new companies, based on external rankings referenced during his presentation. The advisor also highlighted the availability of business and industrial parks for companies considering manufacturing or other operational facilities. Montana, he said, is increasingly attracting companies from technology-intensive sectors. He cited Applied Materials, Oracle, Aurora and Rivian among companies expanding operations in the state. Special support for Indian companies Van Den Abbeel invited Indian companies that are considering Montana to engage directly with the state’s economic-development team. He offered a state-sponsored “red carpet” programme tailored to the individual needs and objectives of companies visiting Montana, including support to understand the business environment and potential investment opportunities. He concluded by positioning Montana around four key pillars, people, place, policy and power, arguing that these factors could provide Indian companies with a competitive platform for entering the US market.   Narayan Kulkarni narayan.kulkarni@mmactiv.com ]]> <![CDATA[Karnataka biosciences companies explore partnerships with Montana]]> https://biospectrumindia.com/news/95/28621/karnataka-biosciences-companies-explore-partnerships-with-montana.html https://biospectrumindia.com/news/95/28621/karnataka-biosciences-companies-explore-partnerships-with-montana.html Thu, 08 Oct 2026 19:23:15 +0530 The Bengaluru leg of the visit of Montana Governor Greg Gianforte brought together a diverse group of Indian biotechnology, biopharmaceutical, medtech, genomics, bio-manufacturing, precision medicine and digital health companies, with several expressing interest in exploring research, technology, clinical development, manufacturing and market-access opportunities with Montana, USA. The CXO-level roundtable, facilitated by the Association of Biotechnology Led Enterprises (ABLE), was held as part of Governor Gianforte’s India visit on October 7–8. The Montana delegation includes senior state officials, economic development representatives, private-sector companies and representatives from Montana State University. The interaction provided Indian companies an opportunity to understand Montana’s capabilities in bioscience research, biopharmaceutical manufacturing, academia and technology development, and identify areas for potential collaboration. The Indian participation reflected the breadth of Karnataka’s biosciences ecosystem. Immuneel Therapeutics, represented by its corporate development and scientific leadership, highlighted its work in CAR-T therapies and its interest in exploring opportunities with the Montana ecosystem. Iom Bioworks presented its work on engineered gut microbes and their potential application in cancer recovery. The company’s research could open avenues for collaboration in microbiome research, translational science and clinical development. Virion Therapeutics, a clinical-stage biotechnology company, is developing novel T-cell-based immunotherapies that use proprietary checkpoint modifiers to restore, enhance, broaden and sustain immune responses, with the objective of developing treatments for cancer and chronic infectious diseases. The company is looking at opportunities to advance its translational and clinical research through international collaborations. In the medical technology space, Cardiotrack highlighted its AI-powered portable electrocardiogram devices and telemedicine platform aimed at making early heart-disease detection more affordable and accessible across India. Its combination of medical devices, digital health and artificial intelligence presents potential opportunities for technology and healthcare collaborations in the US. BrainSight AI presented its functional brain-mapping technology designed to provide clinicians with additional information during neurological procedures and treatments. The company is preparing for entry into the US market and is exploring clinical research collaborations, making academic and healthcare institutions in the US a potential avenue for expansion. The genomics and life-sciences manufacturing segment was represented by Azooka Labs, a Bengaluru-based biotechnology startup incubated at the Indian Institute of Science. The company develops genomic workflow solutions, sustainable DNA/RNA sample-collection kits and non-toxic bio-reagents. Its interest in international partnerships aligns with the growing need for sustainable and accessible genomic technologies. Laurus Bio brought expertise in microbial precision fermentation and integrated bio-manufacturing. As a contract development and manufacturing organisation, the company works across sectors including biopharma, alternative proteins, personal care and food nutrition, creating potential opportunities for collaboration with Montana companies and research institutions in advanced biomanufacturing. In cell therapy and regenerative medicine, Eyestem is developing therapies for retinal diseases and is conducting Phase II clinical trials in India. The company’s interest in international clinical and research partnerships could create opportunities to connect with Montana’s academic and healthcare ecosystem. Prana Xenotransplants (Prana XT) presented its work on addressing the critical shortage of human organs through gene-edited porcine organ transplantation. Its programme integrates gene editing, cloning and surgical technologies and spans research, regulatory development and clinical readiness. Collaboration with US academic and research institutions could support the company’s efforts to advance this emerging field. The roundtable also highlighted opportunities beyond conventional healthcare. Devigere Biosolutions is developing clean-label, sustainable and functional protein concentrates from Indian pulses such as mung bean and cowpea for applications in functional foods, nutraceuticals, sports nutrition and skincare. The company's work could complement Montana’s interests in agriculture, food innovation and value-added bioproducts. String Bio showcased its bio-manufacturing capabilities, including products for agriculture and bio-stimulants, highlighting the potential intersection between biotechnology, agriculture and sustainable production. The academic and incubation ecosystem was represented by the dhaRti BioNEST Incubation Centre at IIT Dharwad, a research and technology incubator focused on translating academic R&D into commercial life-science solutions. The centre provides another potential bridge between Indian research institutions and Montana’s universities and innovation ecosystem. Akshaisarathi Health Care Solutions presented its multidisciplinary approach to healthcare innovation, bringing together medical consultants, IT professionals, data analysts, pharmaceutical chemists and biotechnologists to develop solutions for personalised and precision medicine. Environmental biotechnology and climate-related applications were also part of the discussion. Aspalli Green Sustainable Ecosystem, based in Raichur, Karnataka, showcased its patented Seed Womb technology for land restoration and reforestation. The technology is designed to improve survival rates and accelerate tree growth while reducing water requirements, creating potential areas of collaboration around sustainable land restoration, afforestation and environmental innovation. The range of companies participating in the roundtable demonstrated that the potential India–Montana relationship extends well beyond conventional biotechnology. From CAR-T and cancer immunotherapy to microbiome science, precision medicine, brain mapping, genomics, cell therapy, xenotransplantation, precision fermentation, functional proteins, agricultural biotechnology and reforestation, Indian companies identified multiple areas where Montana’s academic, research and business ecosystem could support their international growth. For the participating Indian companies, Montana offers potential access to research institutions, universities, clinical networks, technology partners and the wider US innovation ecosystem. In turn, the engagement provides Montana with an opportunity to connect with one of India’s most dynamic life-sciences clusters and companies developing technologies for global markets. The Bengaluru interaction therefore marked a first step towards converting the Governor’s trade mission into specific business, research and technology partnerships. The companies expressed interest in taking discussions forward with Montana-based organisations, particularly around joint research, clinical studies, technology development, biomanufacturing, academic partnerships and entry into the US market.   Narayan Kulkarni narayan.kulkarni@mmactiv.com ]]> <![CDATA[Serum Institute of India’s HPV vaccine CERVAVAC® receives WHO prequalification]]> https://biospectrumindia.com/news/95/28597/serum-institute-of-indias-hpv-vaccine-cervavac-receives-who-prequalification.html https://biospectrumindia.com/news/95/28597/serum-institute-of-indias-hpv-vaccine-cervavac-receives-who-prequalification.html Mon, 05 Oct 2026 20:38:53 +0530 CERVAVAC®, India’s first indigenously developed gender-neutral Quadrivalent Human Papillomavirus vaccine (qHPV) developed by Serum Institute of India receives prequalification by the World Health Organization (WHO). This regulatory milestone marks the 32nd WHO prequalification for products/biologicals received by Serum Institute of India. Inclusion on the WHO List of Prequalified Vaccines allows CERVAVAC® to be procured by United Nations agencies.  This recombinant quadrivalent HPV vaccine targets HPV types 6, 11, 16 and 18. It is indicated for girls and boys aged 9 through 26 years. Adar Poonawalla, Chief Executive Officer, Serum Institute of India, said, “WHO prequalification of CERVAVAC® is an important step in strengthening the global response to HPV. This milestone reflects the effectiveness of the vaccine and creates the opportunity for countries to prevent HPV-related risks. We are pleased to see this indigenously developed vaccine reach this achievement, and look forward to contributing to immunisation coverage, advancing global healthcare” Previously approved for its use in India by the Drugs Controller General of India (DCGI), CERVAVAC® is administered for the prevention of diseases caused by the four HPV types. This includes the prevention of anal cancer in boys and young men, and cervical, vulvar, vaginal, and anal cancers in girls and young women. It is also indicated in preventing genital warts, as applicable to the indicated population. Developed in collaboration with the Department of Biotechnology (DBT) and the Biotechnology Industry Research Assistance Council (BIRAC), along with the WHO-IARC (International Agency for Research on Cancer) and the Gates Foundation, CERVAVAC® is a recombinant quadrivalent HPV vaccine targeting HPV types 6, 11, 16 and 18.  ]]> <![CDATA[Strategic Excipient Selection Is Transforming Lyophilisation in Biologics Manufacturing]]> https://biospectrumindia.com/interviews/95/28585/strategic-excipient-selection-is-transforming-lyophilisation-in-biologics-manufacturing.html https://biospectrumindia.com/interviews/95/28585/strategic-excipient-selection-is-transforming-lyophilisation-in-biologics-manufacturing.html Thu, 01 Oct 2026 00:00:00 +0530 The rapid growth of biologics, biosimilars, vaccines and complex injectables is changing the way formulation scientists approach lyophilisation. No longer is excipient selection simply about protecting an active ingredient; increasingly, it is becoming a strategic decision that can influence processing windows, manufacturing efficiency, storage stability and scalability. Recent research involving pharmaceutical-grade dextrans has highlighted this potential. In the study discussed by Pharmacosmos, dextran-containing formulations completed primary drying in approximately five hours compared with 16.5 hours for a sucrose formulation under the investigated conditions, while Dextran 40 also demonstrated strong protein stability in the model system. In an interaction with BioSpectrum India, Anne-Marie Ørkild, Vice President of Carbohydrates Sales & Marketing at Pharmacosmos, discusses how excipients are evolving from supporting ingredients into strategic formulation tools, the science behind Dextran 40 in lyophilised formulations, and how smarter formulation choices could contribute to more robust and scalable biopharmaceutical manufacturing in India and other growth markets. Lyophilisation is critical for the stability of many biologics but can be time- and resource-intensive. What are the key formulation challenges today, and where do you see the greatest opportunities to improve efficiency? Lyophilisation has become an essential tool for stabilising many sensitive pharmaceutical products, particularly proteins that may undergo chemical or physical degradation in solution. But it comes with an important trade-off: freeze-drying can be a long and costly process, and the formulation must protect the molecule through freezing, dehydration and subsequent storage. One of the key challenges is the primary drying step. The temperature that can safely be applied is closely related to the glass transition temperature of the maximally freeze-concentrated formulation. Conventional cryo- and lyoprotectants such as sucrose and trehalose have relatively low glass transition temperatures, which can constrain the drying temperature and contribute to longer cycles.  This is where I believe there is an opportunity to think differently about excipient selection. An excipient should not only be considered for its ability to protect the active ingredient; its physicochemical properties can also influence the manufacturability of the formulation. Research involving Pharmacosmos dextrans illustrates this very well. Dextrans have higher glass transition temperatures than sucrose, allowing higher primary drying temperatures to be investigated without collapse. In the published study from Strøm Larsen B., primary drying was completed in approximately 5 hours for the dextran-containing formulations compared with 16.5 hours for the sucrose formulation.  That demonstrates an interesting principle for drug developers: formulation and process efficiency do not necessarily have to be treated as separate optimisation exercises. The right excipient may contribute to both. Recent findings indicate that Dextran 40 can significantly reduce primary drying time while improving protein stability. What makes dextran particularly effective in lyophilised formulations, and what could these findings mean for drug developers? The key lies in the physicochemical properties of dextran, particularly its glass transition behaviour. The study investigated dextrans across a range of molecular weights and found that both relevant glass transition temperatures generally increased with molecular weight before reaching a plateau at around 40 kDa. Dextran 40 therefore combined a relatively high glass transition temperature of the maximally freeze-concentrated solution with a high glass transition temperature of the dried material.  That matters in two ways. First, the higher glass transition temperature during processing allowed the dextran formulations to be dried at a higher primary drying temperature, significantly shortening primary drying. Second, the high glass transition temperature of the dried formulation was associated with improved stability during storage. What is particularly interesting is that Dextran 40 performed strongly on both dimensions. In this LDH model, the Dextran 40 formulation retained approximately 97% protein activity immediately after freeze-drying and 94% after seven weeks at 40°C. The corresponding sucrose formulation retained approximately 86% immediately after freeze-drying and only 27% following storage at 40°C.  Importantly, these findings should be interpreted in the context of the LDH model system and the specific freeze-drying cycle used in the study, rather than as a universal prediction for all proteins or lyophilised formulations. Protein stabilisation during lyophilisation is also multifactorial and may involve vitrification, preferential exclusion, water replacement, residual moisture, viscosity and molecular interactions, so glass transition behaviour should be viewed as a highly relevant but not exclusive explanatory factor. For drug developers, the message is not that Dextran 40 will automatically be optimal for every molecule. Formulation development is always product-specific. But the results demonstrate that Dextran 40 deserves consideration as a functional pharmaceutical excipient capable of influencing both processability and protein protection, rather than simply as a conventional bulking agent. Sucrose and other excipients are well established in freeze-drying. When should formulation scientists consider Dextran 40, and what advantages can it offer in terms of stability, robustness and processing? Sucrose and trehalose have an established place in lyophilised formulations, and Dextran 40 should not be seen as a universal replacement. The more interesting question is whether formulators are considering the full range of excipient options available when an established formulation presents limitations. Dextran 40 may be particularly interesting when formulators are looking to address challenges such as long primary drying times, limited processing temperatures or insufficient stability during storage. The study by Strøm Larsen et al. provides a good illustration. The higher glass transition temperature of the dextran formulations allowed a higher primary drying temperature to be used. Under the investigated conditions, primary drying was completed in approximately 5 hours with dextran compared with 16.5 hours with sucrose, representing a reduction of more than 60%. Importantly, the resulting cakes remained visually acceptable, with no evidence of collapse and rapid rehydration.  Dextran 40 was particularly interesting from a stability perspective. It retained approximately 97% LDH activity immediately after freeze-drying and 94% after seven weeks at 40°C, compared with approximately 86% and 27%, respectively, for sucrose. At 60°C, the Dextran 40 formulation also showed no visual signs of cake collapse and retained substantially more LDH activity than the sucrose formulation.  Another important finding was that molecular weight matters. The relevant glass transition temperatures increased with dextran molecular weight before reaching a plateau at around 40 kDa. This means molecular weight itself can become another parameter for formulation scientists to consider when optimising a freeze-dried product.  In practical terms, the study highlights how excipient molecular weight and glass transition behaviour can be used more deliberately during lyophilised formulation design, while still requiring product-specific evaluation. The broader message is therefore not that one excipient is always better than another. It is that excipient selection can influence both product stability and processability, and Dextran 40 provides an interesting additional option that formulators may want to evaluate alongside more conventional sugars. As biologics, biosimilars, vaccines and complex injectables continue to grow, how are the expectations from excipients changing? Are they becoming a more strategic part of formulation and product development? Absolutely. As pharmaceutical products become more complex, I think the role of excipients is evolving from being viewed primarily as supporting ingredients towards becoming strategic formulation tools. For a sensitive biological molecule, the choice of excipient can influence much more than stability. It can affect the processing window, manufacturability, storage behaviour and ultimately the robustness of the finished product. The dextran study provides another good illustration. Changing the cryo-/lyoprotectant influenced not only the protection of the model protein but also the temperature that could be applied during primary drying and, consequently, the processing time.  This means excipient selection should ideally be considered early in formulation development rather than simply optimising a process around familiar ingredients by default. There is also a second dimension that becomes increasingly important as a product progresses towards clinical and commercial manufacturing: quality and consistency of the excipient itself. Developers need confidence that the material they select during development can be supplied consistently, at the required pharmaceutical quality and at the scale needed later in the product lifecycle. So yes, I believe expectations are changing. The question is not simply “Does this excipient stabilise my molecule?” but also “What does it contribute to my formulation and process, how robust is it, and can I rely on its quality and supply as my product progresses?” Beyond formulation performance, how can optimised lyophilisation contribute to manufacturing efficiency — particularly around drying cycles, equipment utilisation, energy consumption, scale-up and overall cost? This is potentially one of the most commercially important aspects. Lyophilisation is a time- and resource-intensive manufacturing process, and primary drying is typically one of its longest stages. If formulation optimisation allows that step to be shortened while maintaining product quality, there is potential to improve the overall efficiency of the manufacturing process. The Strøm Larsen et al. study demonstrates the scale of the opportunity. Primary drying was completed after approximately 5 hours for dextran-containing formulations compared with 16.5 hours for sucrose. When a two-hour safety margin was incorporated into the experimental cycles, primary drying was set at 7 hours for dextran versus 18.5 hours for sucrose.  At manufacturing scale, reducing the time a product occupies a freeze-dryer could potentially translate into greater equipment availability, increased throughput and lower resource requirements per batch. It could also become relevant when manufacturers are scaling production or facing constraints in lyophilisation capacity. However, it is important to distinguish between what the study demonstrated and the potential manufacturing implications. The research did not directly measure energy consumption, commercial manufacturing costs, throughput or large-scale equipment utilisation. Those benefits would need to be evaluated for each individual process. What the study does demonstrate is that excipient selection can significantly influence primary drying time while maintaining product quality.  That is an important message because formulation development and manufacturing efficiency are sometimes treated as separate challenges. In reality, decisions made at formulation stage can have important implications for the process that eventually has to be scaled and commercialised. Looking ahead, how do you see lyophilisation and formulation science evolving over the next five years, and what role could pharmaceutical-grade dextrans play as biopharma manufacturing expands in India and other growth markets? I believe formulation science will become increasingly integrated with process development. As biologics, biosimilars, vaccines and other complex products continue to grow, developers will need formulations that do more than stabilise the active ingredient. They will increasingly look for solutions that also support robust manufacturing, scalability, storage stability and reliable commercial supply. In lyophilisation, this should encourage a more systematic understanding of how excipient properties influence both product and process performance. This makes dextran particularly interesting because we should not think of it as one single excipient. Molecular weight, glass transition behaviour and interactions with the active ingredient can all become part of a more rational formulation design strategy. For rapidly expanding pharmaceutical markets such as India, I believe this combination of formulation functionality, pharmaceutical quality and scalability will become increasingly important. As more products progress from development into larger-scale manufacturing, developers need not only innovative formulations but also confidence that their chosen excipients can follow them through that journey. At Pharmacosmos, this is very much how we see our role. With more than 60 years of experience in pharmaceutical-grade carbohydrates, a dedicated cGMP manufacturing facility and a purely water-based dextran manufacturing process without organic solvents, we aim to be a long-term carbohydrate partner for formulation scientists. Our broad range of dextran includes established pharmaceutical-quality grades such as Dextran 40, as well as a wide range of molecular weights, dextran derivatives and customised solutions. This allows us to support evolving formulation needs from early development through scale-up and commercial manufacturing. Our ambition is therefore not simply to supply Dextran 40, but to help formulation scientists identify the carbohydrate solution that best fits their specific formulation and process needs. ]]> <![CDATA[Biodeal Pharma expands into sterile injectables with acquisition of Biological E facility]]> https://biospectrumindia.com/news/95/28568/biodeal-pharma-expands-into-sterile-injectables-with-acquisition-of-biological-e-facility.html https://biospectrumindia.com/news/95/28568/biodeal-pharma-expands-into-sterile-injectables-with-acquisition-of-biological-e-facility.html Tue, 29 Sep 2026 14:56:59 +0530 Biodeal Pharmaceuticals, a leading Contract Development and Manufacturing Organisation (CDMO), has acquired a sterile injectable manufacturing facility in Paonta Sahib, Himachal Pradesh – one of the largest manufacturing facilities in the state – from Biological E Limited. The acquisition marks a strategic expansion of Biodeal's manufacturing platform into sterile injectables for global markets, adding established regulatory credentials, specialised capabilities and significant manufacturing capacity to its portfolio. The facility is equipped for general injectables and Carbapenem manufacturing in vial formats, supported by German-made Groninger processing lines, with current annual capacity of around 135 million units. There is scope to expand to the facility's full capacity of 17 production lines and to add pre-filled syringe (PFS) and lyophilised formats. Biodeal is pursuing PIC/S and EU accreditation for the facility as part of its plans to expand into additional regulated markets. Spread across a 14-acre campus, the Paonta Sahib facility comprises approximately 39,000 square metres of built-up manufacturing space and has the potential to add a further capacity of 30 million units through near-term expansion. Located approximately 50 kilometres from Biodeal’s existing Nalagarh facility, the acquisition also strengthens the company’s manufacturing footprint within Himachal Pradesh’s established pharmaceutical corridor. The facility was acquired from Biological E Limited, a Hyderabad-headquartered vaccine and pharmaceutical manufacturer with nearly seven decades of operations, as part of Biological E's ongoing investment in its new vaccine R&D and CDMO campus in Telangana. With this acquisition, Biodeal adds established manufacturing capacity and credentials to its platform, broadening the range of complex injectable manufacturing it can offer pharmaceutical customers globally - spanning Carbapenems for serious bacterial and drug-resistant infections, and in process of expanding into ready-to-use pre-filled syringe formats, and lyophilised products with extended stability and shelf life. ]]> <![CDATA[Novonesis injects €600 M to build next generation enzyme production facility in India]]> https://biospectrumindia.com/news/95/28417/novonesis-injects-600-m-to-build-next-generation-enzyme-production-facility-in-india.html https://biospectrumindia.com/news/95/28417/novonesis-injects-600-m-to-build-next-generation-enzyme-production-facility-in-india.html Thu, 03 Sep 2026 16:48:38 +0530 Denmark-based Novonesis will expand its facility in Patalganga, Maharashtra and build one of the world’s most advanced enzyme production facilities. The €600 million investment will increase Novonesis’ production capacity to meet rising worldwide demand for the company’s biosolutions and strengthen the flexibility and resilience of its global supply network. The Patalganga expansion is a milestone in Novonesis’ strategy and key to achieving the company’s growth ambitions. The facility, which is expected to be fully operational in 2030, will produce enzymes for a broad range of industries, including biofuels, household care, and food and beverages. This state-of-the-art facility will be integrated into the company’s global production footprint and bring Novonesis closer to customers across the Middle East, India, and Africa. These markets represent an important and growing part of the company’s business and are expected to grow faster than developed markets in the coming years. Patalganga is part of a series of investments Novonesis has made to strengthen its global production setup and serve customers more effectively. Facilities in Rayong, Thailand; Franklinton, North Carolina; Taicang, China; Araucaria, Brazil; and West Allis, Wisconsin, have also been expanded as part of this effort.  ]]> <![CDATA[Zydus' US Sentynl Therapeutics expands rare disease portfolio in partnership with Mereo BioPharma]]> https://biospectrumindia.com/news/95/28294/zydus-us-sentynl-therapeutics-expands-rare-disease-portfolio-in-partnership-with-mereo-biopharma.html https://biospectrumindia.com/news/95/28294/zydus-us-sentynl-therapeutics-expands-rare-disease-portfolio-in-partnership-with-mereo-biopharma.html Wed, 12 Aug 2026 13:33:47 +0530 Sentynl Therapeutics, Inc., a US-based biopharmaceutical company and wholly-owned subsidiary of Zydus Lifesciences, and Mereo BioPharma Group plc, a clinical-stage biopharmaceutical company focused on rare diseases, have entered into an option and license agreement for the US commercial and global manufacturing rights to alvelestat for Alpha-1 Antitrypsin Deficiency-Associated Lung Disease (AATD-LD). Alvelestat is a neutrophil elastase inhibitor being readied for Phase 3 and, if approved, would be the first oral treatment for this rare, progressive genetic lung disease affecting an estimated 50,000-80,000 individuals in the United States. The option and license agreement grants Sentynl the exclusive right to acquire a license to commercialise alvelestat for AATD-LD in the United States, with Mereo retaining commercial rights in the rest of the world. The agreement also grants Sentynl global rights to manufacture alvelestat for AATD-LD and on option exercise, it provides funding for the alvelestat Phase 3 development programme, which could be initiated in early 2027. Mereo will receive a non-refundable option fee from Sentynl and, on exercise of the option, the company would also receive up to $40 million in upfront and R&D payments until NDA filing. Under these terms, Mereo would also be eligible to receive double-digit tiered royalties on US net sales of alvelestat. Mereo will lead the global Phase 3 study and regulatory interactions until the study is completed. However, during the option period, the companies will collaborate to advance manufacturing and streamline the Phase 3 study design. ]]> <![CDATA[Wockhardt launches Antibiotic Academy for scientific dialogue to tackle multidrug resistance]]> https://biospectrumindia.com/news/95/28288/wockhardt-launches-antibiotic-academy-for-scientific-dialogue-to-tackle-multidrug-resistance.html https://biospectrumindia.com/news/95/28288/wockhardt-launches-antibiotic-academy-for-scientific-dialogue-to-tackle-multidrug-resistance.html Mon, 10 Aug 2026 20:38:45 +0530 Mumbai-based pharma firm Wockhardt has announced the launch of Antibiotic Academy, an open scientific learning platform accessible to the registered medical fraternity across India. It aims to facilitate continuous medical education through the exchange of knowledge, scientific discussions, and the sharing of real-world clinical experience among healthcare professionals. This Academy is the first step in building a nationwide scientific movement. Wockhardt hopes to collaborate with clinicians across the country to strengthen the fight against antimicrobial resistance (AMR). Ultimately, the true measure of success will be the number of patients whose lives are saved through better-informed clinical decisions. "There is an urgent need not only to have a new antibiotic like Zaynich, but also to have a science-based platform that fosters constructive dialogue on antimicrobial resistance and its appropriate management. It is essential to use the right antibiotic for the right patient at the right time. We hope this Academy will create a deeper understanding of the current realities of drug resistance and promote evidence-based solutions that enable clinicians to save patients' lives," said Dr. Habil Khorakiwala, Founder Chairman, Wockhardt. "Practices that were considered appropriate a decade ago have been refined by new evidence on diagnosis, dosing, treatment duration and de-escalation. Any initiative that brings clinicians together to exchange knowledge and remain closely connected to science is a step in the right direction. Resistant organisms must be defeated—and patients must win" said Dr Subramaniam Swaminathan, President Clinical Infectious Diseases Society, India. ]]> <![CDATA[BITS Pilani develops sustainable tech to convert biopharma wastewater into reusable water & clean energy]]> https://biospectrumindia.com/news/95/28238/bits-pilani-develops-sustainable-tech-to-convert-biopharma-wastewater-into-reusable-water-clean-energy.html https://biospectrumindia.com/news/95/28238/bits-pilani-develops-sustainable-tech-to-convert-biopharma-wastewater-into-reusable-water-clean-energy.html Thu, 30 Jul 2026 21:00:25 +0530 Scientists at BITS Pilani, Hyderabad have developed an integrated and low-energy technology for wastewater treatment. It can provide a sustainable solution to the management of one of the most problematic wastewater streams in the biopharmaceutical industry. Researchers have successfully demonstrated the technology at the laboratory scale, the research team is now working with Biological E. Limited, one of India's leading vaccine manufacturers based in Genome Valley, Hyderabad, to scaling the system for industrial deployment. The innovative system replaces conventional chemical- and steam-based sterilisation with Pulsed Electric Field (PEF) technology. It enables biopharmaceutical fermentation wastewater to be safely disinfected while recovering reusable water and methane-rich biogas.  The technology could be applied to other pharmaceutical and vaccine production facilities and high-strength industrial wastewaters, to benefit industries with water-saving, energy-recovery and environmentally friendly integrated solutions. The project is supported by the Department of Science and Technology (DST), Government of India, through its ‘Water Technology Initiative’ of the Optimum Water Use in Industrial Sectors programme. The core disinfection technology has been filed for an Indian patent. Biopharmaceutical fermentation wastewater is among the most difficult industrial effluents to treat because it contains millions of live production microorganisms, residual antibiotics, and antibiotic resistance genes. Owing to the associated biosafety risks, industries currently rely on chemical treatment followed by steam-based autoclaving before disposal—a process that is both energy-intensive and expensive. ]]> <![CDATA[Zydus, ICMR proceed with Ph III trial of Desidustat in patients with Sickle Cell Disease]]> https://biospectrumindia.com/news/95/28183/zydus-icmr-proceed-with-ph-iii-trial-of-desidustat-in-patients-with-sickle-cell-disease.html https://biospectrumindia.com/news/95/28183/zydus-icmr-proceed-with-ph-iii-trial-of-desidustat-in-patients-with-sickle-cell-disease.html Thu, 23 Jul 2026 15:11:14 +0530 Ahmedabad-based Zydus Lifesciences has received permission to conduct a Phase III clinical trial of Desidustat for patients with sickle cell disease. Conducted in collaboration with the Indian Council of Medical Research (ICMR), the 203-day study will evaluate the efficacy and safety of Desidustat oral tablets in treating anemia. The trial will enrol 164 patients diagnosed with the disease. Sickle Cell Disease is a significant public health concern in India, especially among tribal populations where prevalence is higher. According to National Health Mission estimates, nearly 20 million people live with the condition, and roughly 50,000 children are born with sickle cell anaemia annually. While treatments like hydroxyurea and blood transfusions exist, their limited accessibility, inconsistent effectiveness, and associated risks remain significant challenges. Zydus and ICMR had earlier completed a Phase II, double blind, randomised, placebo controlled, parallel, multi-centre, proof-of-concept study, co-funded and co-monitored by ICMR-INTENT (Indian National Clinical Trial and Education Network, Clinical Studies and Trial Unit) to evaluate the efficacy and safety of Desidustat oral tablet for treatment of sickle cell disease. The study found that Desidustat was well tolerated up to 150 mg dose, with only minimal adverse events reported. ]]> <![CDATA[DCGI grants market authorisation to Takeda’s dengue vaccine QDENGA]]> https://biospectrumindia.com/news/95/28158/dcgi-grants-market-authorisation-to-takedas-dengue-vaccine-qdenga.html https://biospectrumindia.com/news/95/28158/dcgi-grants-market-authorisation-to-takedas-dengue-vaccine-qdenga.html Mon, 20 Jul 2026 13:01:02 +0530 Takeda Biopharmaceuticals India has announced that the Drug Controller General of India (DCGI) has granted market authorisation (CT-20, New Drugs and Clinical Trials (NDCT) Rules, 2019) for QDENGA, Takeda’s dengue vaccine for the prevention of dengue disease in individuals aged 4–60.   QDENGA is the first dengue vaccine approved in India and can be used in individuals regardless of previous dengue exposure, without the need for pre-vaccination testing.   The approval in India is based on results from Takeda’s global clinical development programme, involving 19 Phase 1, 2 and 3 clinical trials with over 28,000 participants in both endemic and non-endemic regions. This included the pivotal Phase III TIDES (DEN-301) trial which evaluated the vaccine in over 20,000 participants across eight countries over an extended period to evaluate both the long-term safety and efficacy of QDENGA.   This approval is also supported by data from a Phase III clinical trial (DEN-302) conducted in Indian participants, which evaluated the safety and immunogenicity of the vaccine in individuals aged 4–60 years. The study demonstrated that QDENGA was found to be tolerated, safe and immunogenic in healthy adults, adolescents and children.     QDENGA is a tetravalent, live-attenuated vaccine designed to provide protection across all four dengue virus serotypes. The vaccine is administered subcutaneously 0.5 mL as a two-dose regimen, with doses given three months apart.   Following the approval by DCGI, Takeda will continue to collaborate with Indian regulatory authorities, public health stakeholders, and healthcare providers to support the planning, delivery, and availability of QDENGA in India. ]]> <![CDATA[Gates Medical Research Institute & Serum Institute of India to manufacture new TB vaccine candidate]]> https://biospectrumindia.com/news/95/28146/gates-medical-research-institute-serum-institute-of-india-to-manufacture-new-tb-vaccine-candidate.html https://biospectrumindia.com/news/95/28146/gates-medical-research-institute-serum-institute-of-india-to-manufacture-new-tb-vaccine-candidate.html Fri, 17 Jul 2026 23:50:08 +0530 The Gates Medical Research Institute (Gates MRI) has reached a milestone agreement with the Serum Institute of India (SII) to manufacture M72/AS01E, a novel tuberculosis (TB) vaccine candidate. Currently in a Phase 3 clinical trial, M72/AS01E has the potential to be the first new TB vaccine to be introduced in more than a century, a potential breakthrough against a disease that remains the world’s leading infectious cause of death and disproportionately impacts low- and middle-income countries. With this partnership, Gates MRI and SII will begin the process of transferring the technology and know-how required to manufacture the antigen and enable future large-scale production of M72/AS01E. SII expects to invest more than $100 million of its own resources to strengthen manufacturing readiness and capacity building to support potential future supply. GSK, the original developer of the vaccine, will supply the AS01E adjuvant. Initiating this work well ahead of Phase 3 trial results is a deliberate strategy to ensure readiness to produce and distribute the vaccine and begin meeting global demand as quickly as possible, should the trial be successful and regulatory approvals be granted. Gates MRI is sponsoring the Phase 3 clinical trial of M72/AS01E, with funding from the Gates Foundation and Wellcome. The double-blind, randomised trial, which started in March 2024, reached full enrollment in April 2025, of 20,000 participants in South Africa, Kenya, Malawi, Zambia, and Indonesia across 54 sites. ]]> <![CDATA[Gennova Biopharma sells mRNA biz to Immunoscript Life Science for Rs 139.5 Cr]]> https://biospectrumindia.com/news/95/28154/gennova-biopharma-sells-mrna-biz-to-immunoscript-life-science-for-rs-139-5-cr.html https://biospectrumindia.com/news/95/28154/gennova-biopharma-sells-mrna-biz-to-immunoscript-life-science-for-rs-139-5-cr.html Sun, 19 Jul 2026 14:29:52 +0530 Emcure Pharmaceuticals has announced that its subsidiary, Gennova Biopharmaceuticals, has entered into a Business Transfer Agreement (BTA) to divest its mRNA business to Immunoscript Life Science. The transaction will be executed for a lump sum cash consideration of Rs 139.5 crore. This strategic move allows Gennova to reorganise operations and focus on core areas such as research and development, manufacturing, and marketing of biotechnology-based products, including biosimilars and adjacent therapeutic platforms. During FY2025-26, Gennova reported a turnover of Rs 491.7 crore.   The buyer, Immunoscript Life Science, is a Pune-based company promoted by Dr Sanjay Singh, formerly a director of Gennova. The company is focused on precision immunology, combining biological engineering, artificial intelligence and scalable biomanufacturing to develop next-generation vaccines and advanced therapeutics. Immunoscript was incorporated in April 2026 and is not part of Emcure's promoter or group companies.    ]]> <![CDATA[Emcure consolidates Gennova Biopharma ownership, sharpens focus on biologics]]> https://biospectrumindia.com/news/95/28115/emcure-consolidates-gennova-biopharma-ownership-sharpens-focus-on-biologics.html https://biospectrumindia.com/news/95/28115/emcure-consolidates-gennova-biopharma-ownership-sharpens-focus-on-biologics.html Mon, 13 Jul 2026 18:04:36 +0530 Pune-based Emcure Pharmaceuticals has announced the consolidation of its shareholding in biopharma subsidiary Gennova Biopharmaceuticals, alongside a leadership transition, as it sharpens its focus as a biologics and biosimilars company. Emcure is acquiring the entire 12.05% minority stake in Gennova held by Dr Sanjay Singh and others, taking its ownership to 100% and making Gennova a wholly owned subsidiary. Gennova will be led by Samit Mehta and will focus on its biologics franchise — Elaxim®/TENECTASE®, Vintor®, Xgrast®/PEGEX® and Hamsyl® — biosimilars development, and adjacent therapeutic platforms, leveraging its established mammalian and microbial biomanufacturing platforms. Samit Mehta, Whole Time Director &CEO, Gennova Biopharmaceuticals Limited, said, “As part of the One Emcure framework, Gennova will continue to anchor the Group's biologics and biosimilars capabilities. Our work will complement Emcure's broader R&D and pipeline priorities, with a focus on execution, quality and disciplined development across our chosen therapy areas.” The transaction is not expected to have a material impact on Emcure’s consolidated financials or its capital allocation framework. The company’s deleveraging trajectory, capex plans and R&D investment plans remain unchanged. ]]> <![CDATA[Novo Nordisk launches world’s first once-weekly basal insulin in India at Rs 3.71 per unit]]> https://biospectrumindia.com/news/95/28089/novo-nordisk-launches-worlds-first-once-weekly-basal-insulin-in-india-at-rs-3-71-per-unit.html https://biospectrumindia.com/news/95/28089/novo-nordisk-launches-worlds-first-once-weekly-basal-insulin-in-india-at-rs-3-71-per-unit.html Thu, 09 Jul 2026 15:10:26 +0530 Novo Nordisk India has announced the launch of Awiqli® (insulin icodec) in India, the world’s first once-weekly basal insulin, for adults with Type 1 or Type 2 diabetes mellitus. Available in the Indian market from 10 July 2026 onwards, Awiqli® is set to fundamentally transform the insulin regimen for people with diabetes - from a once-daily routine to a once-weekly injection, thereby reducing the annual injection burden from 365 to just 52.  In the ONWARDS-1 clinical programme, Awiqli® achieved superior HbA1c reduction and time in range compared with once-daily glargine U100. More people with type 2 diabetes reached an HbA1c below 7% without hypoglycaemia. Time in Range — an increasingly important complement to HbA1c — was also significantly increased with Awiqli®, giving patients better control through the day. Insulin initiation in India is delayed by 7–9 years on average, driven by fear of injections, anticipation of pain, and cost concerns. Awiqli is priced at Rs 261 per week for 70 units. Pens will be available in 2 volume variants- 1 ml and 3 ml. The MRP for 1 ml pen is Rs 2611 (700 insulin units). This is one pen with 700 units. With 70 units weekly, the pen can last 10 weeks or 2.5 months. The MRP for 3 ml pen is Rs 7833 (2100 insulin units). ]]> <![CDATA[Shantha Biologics partners with Denmark's Novo Nordisk for cartridge fill-finish in diabetes and obesity care]]> https://biospectrumindia.com/news/95/28062/shantha-biologics-partners-with-denmarks-novo-nordisk-for-cartridge-fill-finish-in-diabetes-and-obesity-care.html https://biospectrumindia.com/news/95/28062/shantha-biologics-partners-with-denmarks-novo-nordisk-for-cartridge-fill-finish-in-diabetes-and-obesity-care.html Thu, 02 Jul 2026 17:17:40 +0530 Pharma major Shantha Biologics has signed an agreement with Novo Nordisk, the Danish pharmaceutical company, to manufacture cartridges for injectable medicines at its Hyderabad plant.   It means Shantha Biologics will fill the cartridges and prepare them for use, a final and highly sensitive step in producing drugs like insulin and other injectable therapies. The financial terms and production volumes remain undisclosed.   Cartridge fill-finish involves loading a drug into a slim, pre-filled cartridge that clicks into a pen injector, the format patients use to self-administer their own medication at home rather than in a hospital. The process demands sterile, contamination-free conditions and tight dosing accuracy, since the drug goes directly into the body. This manufacturing format is used across a range of chronic and long-term conditions, including diabetes, obesity, growth hormone deficiencies and certain autoimmune and oncology treatments delivered through biologic therapies.For Shantha Biologics, the deal is validation as much as it is business. The company's fill-finish lines are automated and approved by the US FDA, one of the toughest regulators in the world. Winning this CDMO (contract development and manufacturing organisation) mandate from Novo Nordisk, one of the largest insulin and diabetes care companies globally, signals that a plant in India can meet that bar.The timing works in Shantha Biologics' favour. CDMO partnerships for biologic drugs, medicines made from living cells rather than chemicals, are powering a fast-growing global market. It was valued at $25.32 billion in 2025 and is expected to grow to $38.29 billion by 2031, according to industry estimates. Shantha Biologics said it plans to expand further in vaccines, biologics and injectable manufacturing as that demand grows.The company expects its Hyderabad workforce to grow to around 500 employees in the near future. ]]> <![CDATA[Virbac announces transition of Globion into Virbac Biologicals to strengthen biologicals and vaccines platform]]> https://biospectrumindia.com/news/95/27986/virbac-announces-transition-of-globion-into-virbac-biologicals-to-strengthen-biologicals-and-vaccines-platform.html https://biospectrumindia.com/news/95/27986/virbac-announces-transition-of-globion-into-virbac-biologicals-to-strengthen-biologicals-and-vaccines-platform.html Thu, 18 Jun 2026 19:29:09 +0530 Mumbai-based Virbac Animal Health India has announced the successful integration of Globion into its ecosystem and its transition to Virbac Biologicals. This marks a significant milestone in strengthening Virbac’s biologicals and vaccines capabilities, with a focused emphasis on poultry. The transition reflects the coming together of strong scientific expertise, advanced manufacturing capabilities, and a shared commitment to advancing animal health outcomes. It further reinforces Virbac’s long-term strategy of delivering high-quality, science-led, and trusted solutions to veterinarians, poultry farmers, and animal health stakeholders. Virbac Biologicals will serve as a key pillar within Virbac’s animal health portfolio, enhancing its vaccines and biologicals platform and strengthening its ability to develop innovative solutions that support disease prevention, productivity, and sustainable animal healthcare. Looking ahead, Virbac Biologicals will continue to focus on science, quality, innovation, and customer trust, while further strengthening its manufacturing and research capabilities to meet the evolving needs of the animal health sector. “This integration brings together complementary scientific expertise and manufacturing strength, enabling us to better serve veterinarians, poultry farmers, and animal health stakeholders across IMEA. Our focus remains firmly on innovation, quality, and delivering trusted solutions that create long-term value for our customers and partners”, said Natesan Thanthoni, Area Director – India, Middle East & Africa (IMEA), Virbac Animal Health. ]]> <![CDATA[Ipca Labs announces global licensing collaboration with Bhami’s Research Laboratory for monoclonal antibodies]]> https://biospectrumindia.com/news/95/27952/ipca-labs-announces-global-licensing-collaboration-with-bhamis-research-laboratory-for-monoclonal-antibodies.html https://biospectrumindia.com/news/95/27952/ipca-labs-announces-global-licensing-collaboration-with-bhamis-research-laboratory-for-monoclonal-antibodies.html Sat, 13 Jun 2026 13:15:18 +0530 Mumbai-based Ipca Laboratories and Bhami’s Research Laboratory (BRL) have announced a definitive global licensing agreement granting Ipca access to BRL's proprietary high-concentration subcutaneous biologics delivery platform for the development and commercialisation of multiple monoclonal antibody products targeting oncology and inflammatory diseases. BRL will receive defined milestone fee pertaining to the Technology Transfer, and Royalty on net sales upon commercialisation of the product. BRL is headquartered in Mangalore, with core expertise in protein and peptide drug delivery.   Pranay Godha, MD & CEO, Ipca Laboratories said, “By pairing Ipca’s established science with BRL’s Novel Formulation Platform, we’re accelerating developing affordable biologics for people battling cancer and autoimmune disease worldwide.” Surya Pai, CEO & Co-Founder, BRL said, “We are delighted to be expanding the reach of our novel, proprietary, patented subcutaneous protein delivery platform technology through this exciting partnership with Ipca to develop differentiated biologics for the global market. This strategic partnership is designed to make patient care convenient, affordable and safe." ]]> <![CDATA[Zydus to acquire US-based Assertio for $166.4 M to support oncology therapies]]> https://biospectrumindia.com/news/95/27811/zydus-to-acquire-us-based-assertio-for-166-4-m-to-support-oncology-therapies.html https://biospectrumindia.com/news/95/27811/zydus-to-acquire-us-based-assertio-for-166-4-m-to-support-oncology-therapies.html Wed, 13 May 2026 21:11:53 +0530 Ahmedabad-based Zydus Lifesciences has announced that Zydus Worldwide DMCC, a subsidiary of the company, has signed a definitive agreement through  its wholly owned acquisition subsidiary Zara Merger Sub Inc. with Assertio Holdings, Inc. a US-based pharmaceutical company focused on specialty and oncology supportive-care therapies, to acquire all outstanding shares of Assertio for $23.50 per share in cash, representing total consideration of approximately $166.4 million on a fully-diluted basis, calculated using the treasury stock method. The acquisition provides Zydus with an established US specialty oncology commercial platform, anchored by Assertio’s presence in oncology supportive care. Assertio’s portfolio includes ROLVEDON® (eflapegrastim‑xnst), approved as a Biologics License Application (BLA) by USFDA for long‑acting G‑CSF biologic for the prevention of febrile neutropenia in adult cancer patients receiving myelosuppressive chemotherapy. ROLVEDON® is administered once per chemotherapy cycle in the oncology supportive‑care market. Zydus intends to leverage Assertio’s focused commercial infrastructure and oncology relationships to build and expand its specialty oncology presence in the US. Under the terms of the merger agreement, Zydus will commence a tender offer to acquire all outstanding shares of Assertio common stock.  The tender offer is expected to commence within five business days following the date of the merger agreement. The transaction is expected to close in the financial year 2026-27, subject to satisfaction of all closing conditions. Paul Weiss, Rifkind, Wharton & Garrison LLP is serving legal counsel to Zydus. Moelis & Company LLC is serving as financial advisor to Assertio and Gibson, Dunn & Crutcher LLP is serving as its legal counsel. ]]> <![CDATA[Oxford and Serum Institute of India to advance development of new malaria vaccine candidate]]> https://biospectrumindia.com/news/95/27756/oxford-and-serum-institute-of-india-to-advance-development-of-new-malaria-vaccine-candidate.html https://biospectrumindia.com/news/95/27756/oxford-and-serum-institute-of-india-to-advance-development-of-new-malaria-vaccine-candidate.html Mon, 04 May 2026 22:31:10 +0530 The University of Oxford, through Oxford University Innovation (OUI), and the Serum Institute of India (SII), have entered into a licence agreement to support the development and manufacture of the new malaria vaccine candidate R78C, based on two Plasmodium falciparum blood-stage antigens (RIPR and CyPRA), for use in clinical settings. The agreement grants SII a non-exclusive, worldwide licence to develop R78C as part of a next-generation multi-stage malaria vaccine - a major step designed to target the parasite at multiple points in its lifecycle, with the aim of improving efficacy and durability of protection. The collaboration builds on a longstanding association between Oxford and Serum Institute of India, including the 2019 licence for the R21 pre-erythrocytic stage vaccine and subsequent work to further incorporate the RH5.1 blood-stage vaccine candidate. The licence will enable SII to support the continued development, large-scale manufacture, and potential future commercialisation of the multi-stage vaccine candidate, helping to accelerate its progression into clinical evaluation. This agreement forms part of a broader ecosystem of collaborations supporting the development of novel malaria vaccines. In parallel, SII has entered into a related agreement with ExpreS2ion to secure access to its proprietary ExpreS2 expression platform, which has been used in the clinical-stage production of RH5.1 and R78C vaccine components. Malaria remains a major global health challenge, with hundreds of millions of cases reported annually, predominantly affecting children in sub-Saharan Africa. The development of more effective vaccines is widely recognised as a critical component of long-term malaria control and eradication strategies. ]]> <![CDATA[Amneal Pharma to acquire Kashiv BioSciences to create fully integrated global biosimilar leader]]> https://biospectrumindia.com/news/95/27710/amneal-pharma-to-acquire-kashiv-biosciences-to-create-fully-integrated-global-biosimilar-leader.html https://biospectrumindia.com/news/95/27710/amneal-pharma-to-acquire-kashiv-biosciences-to-create-fully-integrated-global-biosimilar-leader.html Thu, 23 Apr 2026 00:00:00 +0530 Kashiv BioSciences has entered into a definitive agreement to be acquired by Amneal Pharmaceuticals, Inc. The transaction is subject to approval by Amneal shareholders, receipt of regulatory approvals and satisfaction of customary closing conditions and is expected to close in the second half of 2026. This acquisition combines Kashiv’s extensive expertise in the development and manufacturing of biosimilars with Amneal’s scale and commercialisation capabilities. Kashiv is headquartered in Piscataway, New Jersey with operations in the US and India. Amneal is headquartered in Bridgewater, New Jersey, and is a leading biopharmaceutical company with one of the largest affordable medicine businesses in the US. Together, the companies will establish a fully integrated biosimilar platform at scale, to deliver high-quality, affordable therapies, expand patient access, and strengthen their position in the global biopharmaceutical landscape. Dr Sandeep Athalye, Chief Executive Officer at Kashiv said, “We look forward to building on our proven track record of product approvals and advancing our biosimilars pipeline as we work together to expand patient access to life-changing therapies.” ]]> <![CDATA[Biocon announces commercial launch of Bosaya™ and Aukelso™, Denosumab Biosimilars in US]]> https://biospectrumindia.com/news/95/27626/biocon-announces-commercial-launch-of-bosaya-and-aukelso-denosumab-biosimilars-in-us.html https://biospectrumindia.com/news/95/27626/biocon-announces-commercial-launch-of-bosaya-and-aukelso-denosumab-biosimilars-in-us.html Wed, 08 Apr 2026 00:00:00 +0530 Bengaluru-based Biocon Limited has announced the commercial launch of Bosaya™ (denosumab-kyqq) and Aukelso™ (denosumab-kyqq) in the United States (US). Bosaya™ (biosimilar to Prolia®) and Aukelso™ (biosimilar to Xgeva®) are now available by prescription nationwide through specialty pharmacies and healthcare providers. Both products have been previously approved and granted interchangeable designation by the US Food and Drug Administration (FDA) in September 2025, allowing substitution at the pharmacy level in accordance with state laws. Denosumab products play a critical role in bone health, treating osteoporosis and bone complications associated with cancer. In 2024, denosumab products generated approximately $5 billion in US sales, reflecting the growing need for accessible treatment options. Both biosimilars will be available in the most common presentations: Bosaya™ (biosimilar to Prolia®): 60 mg/mL injection for subcutaneous use in a prefilled syringe. Aukelso™ (biosimilar to Xgeva®): 120 mg/1.7 mL (70 mg/mL) injection for subcutaneous use in a single-dose vial. Denosumab is a human monoclonal antibody that targets and binds to Receptor Activator of Nuclear Factor Kappa-B Ligand (RANKL). RANKL is essential for the formation, function, and survival of osteoclasts, the cells responsible for bone resorption. By blocking RANKL, denosumab reduces bone breakdown, increasing bone mass and strength. ]]> <![CDATA[India to emerge as global hub for high-quality biopharma innovation: Endiya Partners report]]> https://biospectrumindia.com/news/95/27595/india-to-emerge-as-global-hub-for-high-quality-biopharma-innovation-endiya-partners-report.html https://biospectrumindia.com/news/95/27595/india-to-emerge-as-global-hub-for-high-quality-biopharma-innovation-endiya-partners-report.html Tue, 31 Mar 2026 00:00:00 +0530 Endiya Partners has released its latest report, “India’s Biopharma Moment: Perspectives from DEMO Biotech,” highlighting an evolution underway in India’s biopharma landscape from a global leader in generics to a high-velocity, cost-effective hub for global biopharma innovation. The report underscores that India is at an inflection point, driven by policy tailwinds, regulatory reforms, and the emergence of high quality clinical-stage assets receiving global validation. India’s unique "Recruitment Alpha" and ‘More Shots on Goal’ advantage positions it well to emerge as a global biopharma innovation hub amidst the rising demand for cost-efficient high quality R&D. The global biopharma industry is undergoing a structural reset as R&D costs soar to $2.2 billion per asset and development cycles average 100 months. Driven by a shift toward complex modalities like gene therapies and mRNA, alongside a looming $300 billion patent cliff and geopolitical volatility, the demand for more cost-efficient, high-velocity R&D ecosystems is increasing. Indian biotech startups benefit from a ‘Recruitment Alpha’, enrolling patients up to ten times faster and advancing drugs to Phase II with <$50 million, enabling 3–4x ‘More Shots on Goal’ compared to the west. However, gaps in pilot scale GMP infrastructure, late-stage funding, talent, and translational research remain. Looking ahead, the report outlines four key pillars for growth: Blended Finance for derisking frontier science and enabling exits, building ‘industrial intelligence’, translational infrastructure and a dynamic regulatory architecture. With sustained policy support and deeper ecosystem collaboration, India is well-positioned to emerge as a global hub for cost-efficient, high-quality biopharma innovation. “This is a great time to be building biotech in India. With the global industry seeking high-velocity R&D and diversified supply chains, India offers a unique combination of clinical depth, technical talent, and cost-efficiency that allows us to solve the world's most complex medical challenges at a fraction of the traditional cost,” said Dr Vedha Sampathkumar, Endiya Partners. ]]> <![CDATA[Novo Nordisk India sets patient-centred price of Rs 202/day for starting dose of Ozempic® and Wegovy®]]> https://biospectrumindia.com/news/95/27598/novo-nordisk-india-sets-patient-centred-price-of-rs-202-day-for-starting-dose-of-ozempic-and-wegovy.html https://biospectrumindia.com/news/95/27598/novo-nordisk-india-sets-patient-centred-price-of-rs-202-day-for-starting-dose-of-ozempic-and-wegovy.html Tue, 31 Mar 2026 00:00:00 +0530 Novo Nordisk India has announced price reductions for its original and well-established semaglutide injections for patients living with type 2 diabetes and obesity or overweight. Effective April 1, 2026, the price of the starting dose of Ozempic® will be reduced by 36%, while that of the starting dose of Wegovy® will be reduced by 48% in India. Ozempic® (0.25 mg) and Wegovy® (0.25 mg) will now be available in India at an effective daily price of Rs 202 or a weekly price of Rs. 1,415 inclusive of taxes. This is done to make these innovative therapies, that are supported by robust clinical evidence and high scientific standards, more accessible to a larger section of people living with diabetes and obesity in India. Ozempic® is the only GLP-1 RA with the broadest range of benefits for people with type 2 diabetes (PwT2D), proven to provide significant glycaemic control, compelling weight loss, along with risk reduction of cardiovascular and kidney events in PwT2D.  Wegovy® delivers quality and sustainable weight loss with proven cardiovascular benefits in people living with overweight/obesity. Both are indicated adjunct to diet and exercise and are prescription only medications that should be used in line with their approved indication under the supervision of a healthcare professional. Novo Nordisk’s semaglutide, the active pharmaceutical ingredient in Wegovy® and Ozempic®, is backed by 50+ clinical trials, 49 million patient years of exposure, and extensive real-world evidence. Both therapies are manufactured using rDNA technology, are available in a pen device with established safety standards, and follow a robust nation-wide cold chain management process.  ]]> <![CDATA[Eveliqure and Serum Institute of India collaborate for development of anti-diarrhoeal vaccines]]> https://biospectrumindia.com/news/95/27531/eveliqure-and-serum-institute-of-india-collaborate-for-development-of-anti-diarrhoeal-vaccines.html https://biospectrumindia.com/news/95/27531/eveliqure-and-serum-institute-of-india-collaborate-for-development-of-anti-diarrhoeal-vaccines.html Sat, 21 Mar 2026 00:00:00 +0530 Austria-based Eveliqure Biotechnologies GmbH, a clinical-stage biotechnology company focused on Shigella and ETEC vaccine development, and Pune-based Serum Institute of India (SII), a Cyrus Poonawalla group company and the world's largest vaccine manufacturer, have announced a strategic collaboration and licence agreement for the development, manufacturing and commercialisation of novel anti-diarrhoeal vaccines targeting significant global health pathogens. Under the collaboration, SII will obtain non-exclusive global rights to ShigETEC, Eveliqure’s proprietary vaccine program targeting Shigella and enterotoxigenic E. coli (ETEC), for paediatric populations. The collaboration aims to develop broad-spectrum anti-diarrhoeal vaccines and accelerate clinical development and global access to these critical vaccines for children. Eveliqure will receive a one-time upfront fee along with development, regulatory, and commercial milestone payments, in addition to royalties on net sales. The companies will collaborate continuously throughout the programme, with SII leading the development and global commercialisation efforts. Eveliqure will retain rights to the traveller and military markets and remains free to pursue additional collaborations in these fields. Diarrhoeal diseases are a leading cause of morbidity and mortality worldwide, particularly among children under five in low- and middle-income countries. Despite improvements in sanitation and healthcare, there remains a substantial need for safe, effective, and broadly protective vaccines. Currently, no licenced vaccines exist to prevent infections from the two most prevalent bacterial pathogens, Shigella and ETEC, which account for approximately 200 million diarrhoea cases annually in children under five and contribute to unacceptably high mortality rates and development deficits (stunting). ShigETEC, an oral live attenuated vaccine candidate, is derived from an engineered Shigella strain lacking the ability to invade gut epithelial cells, eliminating a key virulence feature of shigellosis. By deleting highly variable sugar antigens on the bacterial surface, the vaccine is designed to induce broad-spectrum Shigella immune protection. In addition, ShigETEC expresses ETEC toxoid antigens to induce protective antibodies capable of inactivating potent diarrhoeagenic toxins. ]]> <![CDATA[Telangana turns catalyst for innovation]]> https://biospectrumindia.com/features/95/27412/telangana-turns-catalyst-for-innovation.html https://biospectrumindia.com/features/95/27412/telangana-turns-catalyst-for-innovation.html Sun, 01 Mar 2026 00:00:00 +0530 The global life sciences industry is undergoing a structural transformation. Supply chain resilience, advanced therapeutics, precision medicine, and sustainable bio-manufacturing are no longer future priorities—they are immediate imperatives. Telangana’s Next-Gen Life Sciences Policy 2026–30, unveiled at the World Economic Forum Annual Meeting in Davos, represents a timely and strategic response to these shifts. With clear targets for investment, high-quality job creation, frontier R&D, clinical research, and talent development, the policy signals the State’s intent to move from being a leading manufacturing base to a fully integrated global life sciences innovation ecosystem. Strong investor momentum and Hyderabad’s rising global visibility make this the perfect moment to examine how policy, infrastructure, science, and industry are converging to shape Telangana’s next phase of growth.   From Manufacturing Leadership to Ecosystem Leadership For over two decades, Telangana—anchored by Hyderabad—has been a trusted pharmaceutical and vaccine manufacturing powerhouse. The State today accounts for nearly 40 per cent of India’s pharmaceutical production and contributes close to one-third of global vaccine output. With more than 269 US FDA-approved manufacturing facilities, Telangana has earned deep regulatory credibility across highly regulated global markets. However, as global industry dynamics evolve, leading life sciences hubs are increasingly defined not by volume alone, but by their ability to conceive, develop, clinically validate, and scale innovation. This inflection is articulated clearly by Kiran Mazumdar-Shaw, Executive Chairperson, Biocon Limited, who observes that the global life sciences industry is transitioning from “scale-led growth to an innovation-driven, value-centric model.” Telangana’s Next-Gen Life Sciences Policy directly aligns with this shift by prioritising frontier R&D, advanced manufacturing platforms, and precision medicine—areas that demand deep scientific capability, long-term capital, and ecosystem-level coordination. Over the next five years, this strategic repositioning will elevate Telangana from being a critical manufacturing node in global supply chains to a co-creator of next-generation therapies, platforms, and healthcare solutions.   Frontier R&D as a Core Growth Driver A defining feature of the policy is its strong emphasis on frontier R&D and advanced manufacturing. By actively promoting technologies such as biologics and biosimilars, cell and gene therapy, mRNA platforms, CRISPR technologies, antibody-drug conjugates, oligonucleotides, peptides, and precision fermentation, the policy signals a decisive move toward science-led growth. These platforms represent a step change from traditional small-molecule manufacturing. They are characterised by high entry barriers, complex regulatory pathways, and strong intellectual property creation—factors that favour ecosystems with deep scientific infrastructure and skilled talent. Over the next five years, this focus is expected to drive three structural shifts within Telangana’s life sciences ecosystem: Higher value creation per investment, as advanced therapies and platforms command premium global valuations. Tighter integration between research and manufacturing, enabling faster translation from lab to market. Stronger global innovation partnerships, particularly with multinational biopharma companies seeking end-to-end capabilities in regulated markets. This direction is reinforced by Krishna Kanumuri, Managing Director and Chief Executive Officer, Sai Life Sciences, who notes that the policy creates “a compelling platform for companies to continue partnering with global innovators and advancing high-quality R&D from India for the world.” Over the medium term, such innovation-led investments are likely to anchor long-term capabilities rather than short-cycle, capacity-driven expansions.   Genome Valley and  Cluster-Led Growth The expansion of Genome Valley and the planned establishment of a Bio-Innovation and Bio-Manufacturing Cluster in collaboration with the Government of India will be central to translating policy intent into on-ground outcomes. Genome Valley’s evolution—from India’s first organised life sciences park into a globally networked innovation cluster—illustrates Telangana’s ambition to compete with leading international hubs such as Boston-Cambridge, San Francisco Bay Area, and Greater Tokyo. Cluster-led development enables dense collaboration between startups, multinational companies, CROs, CDMOs, academia, and regulators. Over the next five years, this density is expected to significantly reduce time-to-market for complex therapies, lower entry barriers for startups through shared infrastructure, and encourage cross-pollination of talent and ideas. Satish Reddy, Chairman, Dr. Reddy’s Laboratories Limited, underscores the importance of such ecosystems, noting that strong research and industry integration is essential to “translate scientific advances into meaningful health and economic outcomes.” Telangana’s policy reflects this thinking by positioning infrastructure as a catalyst for innovation rather than merely a real estate intervention.   Clinical Research and Evidence-Driven Healthcare Another transformative pillar of the policy is its focus on strengthening the clinical research ecosystem. Globally, pharmaceutical and biotech companies are grappling with rising clinical trial costs, prolonged approval timelines, and patient recruitment challenges. Telangana’s proposed measures—faster approvals, disease-specific clinical registries, and the operationalisation of initiatives such as the Clinical Innovation Sandbox—directly address these constraints. Over the next five years, these interventions are likely to position Telangana as a preferred destination for clinical trials, real-world evidence generation, and precision medicine research, particularly for diseases with relevance to emerging markets. This aligns with the broader global perspective articulated by Shyam Bishen, Head of the Centre for Health & Healthcare and Member of the Executive Committee, World Economic Forum, who emphasises that the future of healthcare will be shaped by ecosystems that bring together science, technology, talent, and policy coherence. Telangana’s focus on privacy-compliant digital health records and clinical registries lays the foundation for population-scale, data-driven healthcare innovation.   Scaling the Pharma Services Opportunity The policy’s explicit focus on expanding the pharma services ecosystem—particularly Contract Research Organisations (CROs) and Contract Development and Manufacturing Organisations (CDMOs)—reflects a clear understanding of global outsourcing trends. As innovator companies seek flexibility, speed, and high-quality partners across the discovery-to-commercialisation continuum, service-led models are becoming central to global life sciences value chains. Telangana’s ambition to scale the pharma services sector from an estimated $2 billion to approximately $10 billion over the coming years represents a significant growth opportunity. Over the next five years, this expansion is expected to generate high-skill employment, strengthen global client linkages, and diversify the State’s life sciences revenue base beyond product manufacturing. This trajectory resonates with Madeleine Roach, Executive Vice President, Business Operations, Sanofi, who highlights the importance of advanced biomanufacturing, talent ecosystems, and regulatory excellence in redefining how global pharmaceutical companies serve patients worldwide.   MedTech, Diagnostics, and the Convergence of Biology and Engineering The policy’s focus on diagnostics, medical electronics, and MedTech reflects the growing convergence of biology, engineering, and data science in modern healthcare. As healthcare systems worldwide shift toward early diagnosis, minimally invasive interventions, and remote patient monitoring, MedTech innovation is becoming a critical pillar of healthcare delivery. The expansion of the Medical Devices Park and targeted support for diagnostics manufacturing are expected to strengthen Telangana’s MedTech ecosystem over the next five years—reducing import dependence while integrating domestic capabilities into global supply chains. Majid Kaddoumi, Executive Vice President, Eurasia, Medtronic, notes that forward-looking policy frameworks are essential for accelerating MedTech-led innovation. The presence of global engineering and innovation centres in Hyderabad underscores the State’s growing role in high-end medical technology development.   Talent as the Cornerstone of Long-Term Competitiveness Among the most enduring impacts of the Next-Gen Life Sciences Policy will be its emphasis on talent development. The proposed Telangana School of Life Sciences and associated skilling platforms reflect a recognition that sustainable competitiveness depends on a future-ready workforce. Over the next five years, industry-aligned curricula, structured internships, certification programmes, and lifelong learning pathways will help build talent pools in biologics, advanced analytics, artificial intelligence, regulatory sciences, and health economics. This focus on employability and inclusion ensures that sectoral growth translates into broad-based socio-economic impact. Dr Satyanarayana Chava, Executive Director and Chief Executive Officer, Laurus Labs, describes the policy as “unique and transformative,” noting that it lays out a clear roadmap for leadership in emerging areas of healthcare through innovation-driven growth.   Sustainability and Responsible Bio-Manufacturing Sustainability is increasingly becoming a decisive factor in global life sciences competitiveness. Telangana’s Green Pharma City—with its emphasis on zero liquid discharge, centralised waste management, energy efficiency, and net-zero practices—positions the State at the forefront of sustainable bio-manufacturing. Over the next five years, this focus will enhance Telangana’s attractiveness to global companies facing rising ESG expectations from regulators, investors, and customers, while also ensuring environmentally responsible industrial growth.   A Five-Year Outlook: From Participation to Global Leadership Taken together, Telangana’s Next-Gen Life Sciences Policy 2026–30 is poised to reshape the State’s life sciences industry in three fundamental ways over the next five years: Elevating Telangana’s role from a manufacturing hub to a global innovation partner. Deepening ecosystem integration, connecting science, industry, policy, and talent. Embedding sustainability, resilience, and long-term value creation into growth. As Shakthi M. Nagappan, Chief Executive Officer, Telangana Life Sciences, notes, the policy anticipated global shifts toward advanced manufacturing, deep innovation, and clinical research—trends now reinforced by national priorities and global industry movements. With strong leadership, disciplined execution, and global alignment, Telangana is positioning itself not merely to participate in the future of life sciences—but to help define it. The next five years will be critical in consolidating Hyderabad and the State at large as a globally integrated, innovation-led life sciences ecosystem that is competitive, sustainable, and future-ready.   Narayan Kulkarni (narayan.kulkarni@mmactiv.com) ]]> <![CDATA[India is positioned to become a major global hub for biologics development and manufacturing: Manoj Kumar Panicker ]]> https://biospectrumindia.com/news/95/27396/india-is-positioned-to-become-a-major-global-hub-for-biologics-development-and-manufacturing-manoj-kumar-panicker-.html https://biospectrumindia.com/news/95/27396/india-is-positioned-to-become-a-major-global-hub-for-biologics-development-and-manufacturing-manoj-kumar-panicker-.html Thu, 26 Feb 2026 00:00:00 +0530 India’s biologics and biosimilars market is entering a decisive growth phase, and the opportunity is both immediate and transformative. With several global biologics going off patent, rising demand for affordable therapies, and strong government backing through initiatives such as Biopharma Shakti, Manoj Kumar R Panicker, General Manager – South Asia, Cytiva believes India is positioned to become a major global hub for biologics development and manufacturing. Panicker, who transitioned from a mechanical engineering background into life sciences innovation and holds 12 international patents, says the convergence of engineering excellence and bioprocess innovation is unlocking new commercial possibilities. “India already has strong capabilities in generics and vaccines. The next wave is biosimilars and complex biologics, where process efficiency, speed to market, and regulatory readiness will define competitive advantage,” he notes. India’s biosimilar opportunity is particularly significant as high-value biologics in oncology, immunology, and rare diseases lose patent protection across regulated markets such as the US and Europe. Indian biopharma companies and CDMOs (Contract Development and Manufacturing Organizations) are well placed to capitalize on this shift due to cost competitiveness, scientific talent, and expanding regulatory expertise. Panicker highlights that the demand is no longer limited to domestic needs — Indian manufacturers are increasingly targeting semi-regulated and highly regulated international markets. Cytiva’s recent investments in India reflect this confidence. The company has expanded its manufacturing footprint in Pune and established a 30,000 sq. ft. Fast Track Process Development Services facility equipped with advanced bioreactors and chromatography systems. According to Panicker, such infrastructure is critical for accelerating molecule-to-market timelines. “Biologics development cannot shortcut biology, but it can eliminate inefficiencies. The real market opportunity lies in reducing trial-and-error cycles and improving process robustness early,” he explains. Beyond biosimilars, Panicker sees strong growth potential in novel biologics, orphan drugs, and advanced therapies. Academic research output in India has been robust, but commercialization has historically lagged. With stronger incubator ecosystems, policy incentives, and global partnerships, more molecules are expected to transition from lab-scale innovation to industrial-scale production. Looking ahead, Panicker believes India’s biologics market could witness sustained double-digit growth over the next decade, fueled by patent expiries, government policy support, and global demand for cost-effective therapies. “This is not just a cyclical opportunity,” he says. “It is a structural shift. India has the science, the scale, and now the infrastructure to become a leading biologics powerhouse.”   Narayan Kulkarni (narayan.kulkarni@mmactiv.com) ]]> <![CDATA[India’s next growth phase will be driven not just by infrastructure, but by capability building and process excellence: Dr Uma Sinha Datta]]> https://biospectrumindia.com/news/95/27397/indias-next-growth-phase-will-be-driven-not-just-by-infrastructure-but-by-capability-building-and-process-excellence-dr-uma-sinha-datta.html https://biospectrumindia.com/news/95/27397/indias-next-growth-phase-will-be-driven-not-just-by-infrastructure-but-by-capability-building-and-process-excellence-dr-uma-sinha-datta.html Thu, 26 Feb 2026 00:00:00 +0530 As India accelerates its ambitions in biologics and biosimilars, the country’s next growth phase will be driven not just by infrastructure, but by capability building and process excellence said Dr Uma Sinha Datta, Director – Process Development at Cytiva India. Speaking about the evolving biopharma landscape, Dr Uma emphasised that while India has long been recognised for its strength in generics and vaccines, biologics demand a fundamentally different ecosystem. “Biopharma manufacturing is science-intensive and skill-intensive. It requires hands-on training, exposure to advanced equipment, and deep understanding of both upstream and downstream processes,” she said. At the core of Cytiva India’s strategy is its Fast Track Process Development Services (PDS) facility in Bangalore — a 30,000 sq. ft. centre equipped with advanced bioreactors up to 200 litres, chromatography systems, and integrated downstream processing platforms. According to Dr Uma the facility is designed not only to support companies in accelerating development timelines but also to address one of the sector’s biggest bottlenecks: skilled talent. “Unlike IT or traditional pharma, biologics training cannot be purely theoretical,” she explained. “It involves expensive consumables, complex instruments, and regulatory precision. Our programmes are structured to simulate real manufacturing environments so professionals gain practical exposure, not just conceptual knowledge.” Dr Uma noted that the centre offers modular three- to five-day industry programmes covering upstream process development, downstream purification, scale-up strategies, and regulatory readiness. In addition, collaborations with academic institutions and sector skill councils are underway to create blended learning models combining digital coursework with immersive laboratory experience. Beyond skilling, Dr Uma underscored the importance of process optimisation in unlocking market opportunity. While biological systems follow fixed timelines, inefficiencies in development can significantly delay commercialization. “Fast Track does not change biology,” she clarified. “What it changes is how efficiently we move from molecule to market. By reducing avoidable iterations and improving process robustness early, companies can save both time and cost.” Looking ahead, Dr Uma sees India’s biologics ecosystem evolving into a globally competitive network anchored by biotech clusters in Bengaluru, Hyderabad, Pune, and Ahmedabad. “The opportunity is significant,” she said. “If we invest equally in infrastructure and human capital, India can move from being a cost-effective manufacturer to becoming a centre of excellence in biologics development.”   Narayan Kulkarni (narayan.kulkarni@mmactiv.com) ]]> <![CDATA[Vaccine Group Registers Highest 24.4% Value and 32.3% Unit Growth in IPM in Jan 2026: Pharmarack ]]> https://biospectrumindia.com/news/95/27310/vaccine-group-registers-highest-24-4-value-and-32-3-unit-growth-in-ipm-in-jan-2026-pharmarack-.html https://biospectrumindia.com/news/95/27310/vaccine-group-registers-highest-24-4-value-and-32-3-unit-growth-in-ipm-in-jan-2026-pharmarack-.html Wed, 11 Feb 2026 00:00:00 +0530 The Indian Pharmaceutical Market (IPM) recorded monthly sales of Rs 21,208 crore in January 2026, registering a strong 10.2 per cent value growth and 1.8 per cent unit growth, according to PHARMARACK, with super groups continuing to drive market performance. Cardiac therapies remained the largest contributor, accounting for 14 per cent of IPM value, and delivered a robust 14.0 per cent value growth along with 4.5 per cent unit growth during the month. Anti-Diabetic therapies contributed 10 per cent to overall IPM value and emerged as one of the fastest-growing large segments, posting a sharp 15.2 per cent value growth supported by 5.5 per cent unit growth. Respiratory therapies, contributing 9 per cent to IPM sales, recorded a value growth of 9.7 per cent with 3.9 per cent unit growth, while Neuro/CNS and Dermatology therapies showed steady momentum with value growth of 10.7 per cent and 9.8 per cent respectively. Vaccines stood out as the strongest performer among all super groups in January 2026, recording the highest value growth of 24.4 per cent despite a relatively small 1 per cent contribution to IPM value, and significantly outperforming other therapies with an exceptional 32.3 per cent unit growth, indicating sharp demand acceleration. Other emerging segments such as Urology and Anti-Neoplastics also posted double-digit value growth; however, certain super groups including Gastrointestinal, Pain/Analgesics, Vitamins, Minerals and Nutrition, Hormones and Sexual Health witnessed a decline in unit growth during the month, highlighting selective volume pressure amid an otherwise healthy value-led growth environment. ]]> <![CDATA[Global pioneers to address BioAsia 2026 in Hyderabad on February 17 & 18]]> https://biospectrumindia.com/news/95/27301/global-pioneers-to-address-bioasia-2026-in-hyderabad-on-february-17-18.html https://biospectrumindia.com/news/95/27301/global-pioneers-to-address-bioasia-2026-in-hyderabad-on-february-17-18.html Mon, 09 Feb 2026 00:00:00 +0530 Global pioneers from the world of science, artificial intelligence (AI) and biopharmaceutical innovation will converge in Hyderabad as BioAsia 2026, Asia’s premier life sciences and healthcare forum, gets underway on February 17 & 18. The two-day conference will bring together some of the most influential scientific leaders, AI visionaries and industry CEOs who are shaping the future of next-generation medicines and digital-first healthcare. Held under the theme “TechBio Unleashed: AI, Automation & the Biology Revolution,” BioAsia 2026 comes at a defining inflection point for global healthcare, as artificial intelligence and programmable biology rapidly move from research labs into real-world drug discovery, development and manufacturing. Among the global pioneers addressing the conference are Dr Stefan Miltenyi, Founder and President of Miltenyi Biotec; Dr Howard Y. Chang, Chief Scientific Officer of Amgen; Pushmeet Kohli, Vice President of Science at Google DeepMind; Madeleine Roach, Executive Vice President and Head of Business Operations at Sanofi; and Anton Groom, Chief AI Officer at MSD. Besides Dr Despina Solomonidou, EVP & Global Head – Technical Research & Development, Novartis (Switzerland), Rashmi Kumar, SVP & Chief Information Officer, Medtronic (USA), Eamonn Warren, Group Vice President – Manufacturing (API & Dry Products), Eli Lilly (USA), Badhri Srinivasan, Group CEO, Unilabs (Switzerland) will also address key sessions across the two days. The conference will open with inaugural addresses by A. Revanth Reddy, Chief Minister of Telangana, and D. Sridhar Babu, Minister for Information Technology, Electronics, Communications, Industries and Commerce, reaffirming the State’s commitment to positioning Hyderabad among the world’s leading life sciences hubs. A special Telangana Rising Vision 2047 session will outline the State’s long-term roadmap for AI-enabled R&D, advanced biologics and next-generation biomanufacturing, reinforcing Hyderabad’s role as a global TechBio innovation ecosystem. Across nine high-impact sessions and a marquee CEO Conclave, BioAsia 2026 will host global leaders from top pharmaceutical, MedTech and AI organisations, alongside leading Indian innovators, making it a definitive platform for collaboration, insight and investment in the life sciences sector. ]]> <![CDATA[Rising awareness, and growing emphasis on prophylactic care to drive steady growth of vaccines in 2026: Sheetal Sapale]]> https://biospectrumindia.com/news/95/27294/rising-awareness-and-growing-emphasis-on-prophylactic-care-to-drive-steady-growth-of-vaccines-in-2026-sheetal-sapale.html https://biospectrumindia.com/news/95/27294/rising-awareness-and-growing-emphasis-on-prophylactic-care-to-drive-steady-growth-of-vaccines-in-2026-sheetal-sapale.html Sat, 07 Feb 2026 00:00:00 +0530 The vaccines segment in the Indian pharmaceutical market continued its steady upward trajectory in December 2025, supported by predictable birth cohorts, rising adult immunization awareness, and a growing emphasis on preventive healthcare. Despite no major new molecule or combination launches in the last two years, the category demonstrated resilience, underlining the structural strength of prophylactic therapies in India’s evolving healthcare landscape. In value terms, the vaccines market clocked total sales of Rs 2,313 crore, registering a 17 per cent year-on-year value growth, driven primarily by 10 per cent volume growth and a 5 per cent price increase, while new product contribution remained marginal at 2 per cent. Growth acceleration during the year was largely powered by adult immunisation, increased rabies and influenza uptake, and sustained demand for immunoglobulins, reflecting expanding use beyond paediatric vaccination programmes. Among subgroups, Bacterial Vaccines and Viral Vaccines each contributed 25 per cent of the overall vaccines value, with bacterial vaccines delivering a strong 20 per cent value growth to Rs 589 crore, backed by 12 per cent volume growth and 6 per cent price growth. Viral vaccines reached Rs 583 crore, growing at a more moderate 8 per cent, indicating stable but mature demand patterns. Combination vaccines, accounting for 19 per cent share, recorded one of the fastest expansions, growing 20 per cent to Rs 440 crore, highlighting continued preference for simplified immunisation schedules. Antitoxic Sera, with a 14 per cent contribution, grew 13 per cent to Rs 323 crore, supported mainly by volume-led demand, particularly in emergency and exposure-driven use cases. Commenting on the trend, Sheetal Sapale, Vice President – Commercial at Pharmarack Technologies, said, “Predictable birth cohorts, rising awareness, and growing emphasis on prophylactic care continue to drive steady growth in the vaccines segment.” Looking ahead to 2026, the vaccines segment is expected to remain a low-volatility, high-relevance growth pillar, benefiting from public health prioritisation, expanding private market participation, and increasing integration of preventive care into routine healthcare decision-making. ]]> <![CDATA[Industry praises Union Budget 2026 with milestone announcements for biopharma and healthcare ecosystem]]> https://biospectrumindia.com/news/95/27261/industry-praises-union-budget-2026-with-milestone-announcements-for-biopharma-and-healthcare-ecosystem.html https://biospectrumindia.com/news/95/27261/industry-praises-union-budget-2026-with-milestone-announcements-for-biopharma-and-healthcare-ecosystem.html Sun, 01 Feb 2026 00:00:00 +0530 The Union Budget for 2026-27 was presented by the Finance Minister Nirmala Sitharaman on 1st February 2026, right after which a surge of responses and views have been flowing in from the industry experts. While some are praising the key announcements made for the biopharma, ayurveda and healthcare sectors in the Budget, others express further expectations.   “By placing biopharma among the seven strategic frontier sectors and launching Biopharma Shakti with an outlay of Rs10,000 crore over five years, the Union Budget makes a decisive investment in India’s health and innovation future. As India’s disease burden shifts toward cancer, diabetes and autoimmune disorders, biologics and biosimilars will be central to improving longevity and quality of life. This initiative—spanning manufacturing scale-up, global-grade regulation, new NIPER institutions and a nationwide clinical trials network—can firmly position India as a global biopharma manufacturing hub.” Kiran Mazumdar Shaw, Chairperson, Biocon Group   "The Union Budget 2026 marks an important milestone for both biotech and biopharma ecosystem. With significant investments fostering innovation, upskilling and technology adoption, participation by both domestic and international players will bolster manufacturing infrastructure. The emphasis on expanded research, clinical trials, regulatory reforms and the creation of a network of 1,000 accredited clinical trial sites positions India to move up the value chain as a high-impact biotech innovation hub, with the potential to improve treatment options across cancer, autoimmune and metabolic conditions. Sustained attention to specialised skills and quality frameworks will be key to ensuring that innovation is translated safely and effectively into patient care." Dr Priya Kapoor G. Hingorani, Managing Director, Miltenyi Biotec India and VP APAC    “The commitment to upgrading drug testing facilities for Ayurveda, with a focus on quality and skilled manpower to support exports, further reinforces the government’s intent to build robust quality infrastructure across healthcare segments. This approach aligns well with the India EU free trade agreement, which opens access to regulated global markets where compliance and quality are critical.” Dr Saurabh Arora, Managing Director, Auriga Research   “The Budget’s proposal to add 10,000 medical seats in the current year and 75,000 seats over the next five years directly addresses the growing demand for doctors, specialists, and skilled healthcare workers. Alongside this, focused skilling initiatives for caregivers and allied professionals will strengthen frontline healthcare delivery and improve patient outcomes across urban and rural India.” Anuj Chahal, Founder and CEO of Maverick Simulation Solutions   "Union Budget 2026 is pushing medical value tourism from a “hospital visit” into a full-stack, globally benchmarked care experience. The five regional medical value tourism hubs can standardise patient journeys across diagnostics, treatment, post-care and rehabilitation, while easing pressure on metros by building credible capacity in Tier 2 and Tier 3 cities. What stands out this year is the emphasis on technology as a growth lever, especially AI-enabled diagnostics, clinical decision support, patient coordination, and faster turnaround on care pathways, all of which directly improve international patient confidence and outcomes." Pankaj Chandna, Co-Founder, Vaidam Health   "Mental health services in Western India require urgent attention, and the expansion of NIMHANS 2.0 can help fill the gap. Emergency and trauma care in district hospitals will also be strengthened for vulnerable populations. While customs duties are proposed on 17 life-saving drugs, seven additional rare diseases will be exempted for personal imports of medicines and specialised nutrition." Dr Simon Grant Physician and Trustee, Ruby Hall Clinic Pune   "While the Budget makes important strides, structural reforms remain necessary to unlock the IVD/MedTech industry’s full potential. Rationalising inverted duty structures, enabling faster regulatory pathways, expanding targeted export incentives and offering dedicated fiscal support for medical-assistive device development and clinical validation will be key to sustaining momentum. Clear policy frameworks for Production Linked Incentive (PLI) expansions in diagnostics and structured R&D funding would further strengthen India’s competitiveness." Jatin Mahajan, President, Association of Diagnostics Manufacturers of India (ADMI)   "A particularly impactful measure is the exemption of basic customs duties on 17 cancer drugs and the extension of import duty exemptions to medicines for seven additional rare diseases. This is a strong patient-first intervention that directly reduces the cost burden of advanced, often life-saving therapies for families facing cancer and rare diseases. By easing the financial barriers to accessing complex treatments, the Budget meaningfully advances equitable access to care at a time when the burden of non-communicable diseases such as cancer, autoimmune disorders, and diabetes continues to rise. Importantly, this step also reinforces India’s focus on improving access to cutting-edge therapies while fostering a supportive environment for innovation and global collaboration." Anil Matai, Director General, OPPI   "The proposed biopharma-focused network, including new and upgraded NIPERs and a nationwide ecosystem of 1,000 accredited clinical trial sites, will significantly reinforce India’s research, talent, and translational capabilities. Equally important is the government’s focus on strengthening the Central Drugs Standard Control Organisation (CDSCO), which will enable faster, science-led approvals aligned with global regulatory benchmarks." Aditya Sharma, Head of Process Solutions, India Region, Merck Life Science   "The expansion of medical education and focus on strengthening cancer care at the district level reflect a forward-looking approach to India’s evolving disease burden. The Budget’s recognition of rising challenges such as obesity, diabetes, autoimmune disorders, lifestyle disorders, and mental health calls for greater emphasis on prevention, early diagnosis, and integrated care models." Dr Ashutosh Raghuvanshi, Managing Director & CEO, Fortis Healthcare   "The creation of new All India Institutes of Ayurveda and the upgradation of the WHO Global Traditional Medicine Centre reflect a progressive approach to integrating modern and traditional systems of medicine. Equally encouraging are the reduction of tax-collected at source (TCS) from 5% to 2% for education and medical purposes." Varun Khanna, Group MD, Quality Care India   "Very significant is the Budget’s focus on accelerating AI adoption across healthcare, education and research. By integrating life sciences with AI-enabled screening, clinical decision-making and talent development, the government is laying the foundation for a future-ready healthcare ecosystem one that supports healthier, longer lives and strengthens India’s position as a global hub for healthcare innovation." Masaharu Morita, Founder and Program Director, NURA - Ai Health Screening Centre   "For India’s $50-billion pharmaceutical industry, which contributes nearly 2.5% to GDP, this Budget reinforces the shift from volume-led growth to value- and innovation-driven leadership. Complementing these initiatives with restoration of Weighted R&D Deduction up to 200% and expansion of PLI support to advanced modalities, APIs, biosimilars, and complex generics would further accelerate domestic manufacturing, reduce import dependence, and position India as a trusted global supplier of high-quality, affordable biopharmaceutical solutions. In the past such incentives were at times also shared by the biomedical devices and medical equipment. We look forward to continuity of reforms to make manufacturing competitive by the assurance given by the FM on deregulation and reduction of regulatory compliance burden so that we can become globally competitive and take advantage of the recent FTAs with EU, EFTA & UK." Rajiv Nath, Forum Coordinator, Association of Indian Medical Device Industry (AiMeD)   "The addition of new NIPERs and the upgrading of existing ones will expand opportunities for advanced scientific education and skills development, building the talent pipeline essential for innovation-led growth. Recognising the rising burden of non-communicable diseases, particularly cancer, the budget also provides direct relief for patients by exempting basic customs duty on 17 cancer drugs and medicines and extending import duty exemptions to seven additional rare diseases. Combined with regulatory simplification through central–state coordination, these measures are set to strengthen India’s biopharma ecosystem while ensuring patients in India and across the world continue to have access to affordable, high-quality medicines. We look forward to studying the detailed budget to further understand its impact on the pharmaceutical sector." Satish Reddy, Chairman, Dr. Reddy’s Laboratories Limited   "The Budget reinforces a holistic, patient-centric approach to healthcare, including mental health, AYUSH, medical tourism, and trauma care. A strong care ecosystem will train 1.5 lakh multiskilled caregivers in wellness, yoga, and medical support. Additionally, 17 cancer drugs and 7 rare disease drugs have been exempted from customs duty to improve patient access." Sudarshan Jain, Secretary General, Indian Pharmaceutical Alliance    "Initiatives such as 75,000 new medical college seats, upgraded allied health institutions, training of 1.5 lakh caregivers, and new mental health institutes in Ranchi and Tezpur will enhance access to quality care, particularly in underserved areas. The Rs 10,000-crore Biopharma Shakti programme will strengthen India’s domestic manufacturing and research ecosystem, supporting long-term innovation." Ameera Shah, President, NATHEALTH and Promoter & Executive Chairperson, Metropolis Healthcare   "Over the next five years, long-term policy clarity, workforce readiness, and manufacturing scale can take India beyond small-molecule dominance and drive equitable healthcare access by 2030 and put the country strongly on its track towards Viksit Bharat 2047. Scaling manufacturing, supported by regulatory clarity and clinical readiness, is how India can establish defensible leadership in the global biopharma space." Amit Mookim, Board of Director and CEO, Immuneel Therapeutics and Member of NATHEALTH   "Patient-centric wins include duty exemptions on lifesaving cancer/rare-disease drugs for immediate relief, plus medical value tourism, mental health infrastructure, allied workforce skilling, and digital integration for holistic delivery. From an industry and MSME perspective, while the overall direction is strongly positive, there remains an opportunity to further catalyse innovation. Expanding allocations under the PRIP framework and reinstating a 200% weighted R&D tax deduction for in-house pharmaceutical research would significantly accelerate private-sector investment in high-risk areas such as biologics, biosimilars, novel drug delivery systems and complex therapies. Overall, Budget 2026 builds a solid foundation for affordable, innovation-led healthcare, positioning India for global biopharma leadership." Nikkhil K. Masurkar, CEO, ENTOD Pharmaceuticals   "The focus on people is especially heartening. Adding 10,000 medical seats in the coming year, alongside training 1.5 lakh caregivers and scaling allied health disciplines, can strengthen the Prime Minister's vision of Heal in India, Heal by India. Supporting states to create five hubs for medical tourism will elevate quality standards across regions. We appreciate the reaffirmed commitment to mental health and trauma care through the proposal to establish NIMHANS-2, upgrade apex mental health institutions in Ranchi and Tezpur, and expand emergency and trauma care capacity by 50% in district hospitals through dedicated centres." Dr Prathap C Reddy, Chairman- Apollo Hospitals   "Strengthening the CDSCO is a crucial step toward building deeper trust in India’s healthcare system. For patients, it means safer access to high-quality, innovative therapies. For the country, it strengthens our credibility as a global healthcare destination. The proposal to develop new regional medical centres is equally significant, bringing advanced healthcare closer to communities beyond metros. When combined with technology-led diagnostics and affordable access, these measures can fundamentally change health outcomes at scale." Aditya Kandoi, Founder & CEO, Redcliffe Labs   "Investments in allied health services and workforce development will lead to decentralising care delivery, strengthening last-mile access and improving patient outcomes. The focus on cancer and rare diseases through duty exemptions will help ease the burden on patients and improve access to innovative therapies." Rajwinder Mehdwan, Managing Director & CEO – Roche Pharma India & Neighbouring Markets   "The Union Budget 2026–27 will play a crucial role when it comes to strengthening stroke care in India. The proposal to develop regional medical hubs through public–private partnerships can greatly improve access to timely stroke diagnosis, emergency intervention and structured rehabilitation. Stroke outcomes depend on rapid treatment, specialised infrastructure and coordinated post-care, all of which these integrated hubs are well positioned to provide. The emphasis on research, training and upgraded healthcare facilities will also support better clinical protocols and skilled manpower for stroke management." Dr Arvind Sharma, Secretary, Indian Stroke Association (ISA)   “The Budget’s focus on building capacity for mental healthcare across the country is a much awaited step. Significant announcements include upgrade of existing institutions for allied mental health professionals—including applied psychology and behavioural health and the announcement of new mental health institutes in Tezpur and Ranchi along with a second NIMHANS in North India; all signaling a clear intent to strengthen public infrastructure & timely trauma support." Neha Kirpal, Founding Cohort Member, India Mental Health Alliance (IMHA)    "Support for manufacturing depth, skill development and improved access in Tier II, Tier III and underserved regions will be critical in advancing the Make in India vision and positioning India as a trusted global hub for high-quality medical technologies. We also look forward to continued momentum on earlier healthcare commitments, including the expansion of oncology infrastructure, which will be vital in addressing India’s growing cancer burden.” Dr Shravan, Managing Director, BPL Medical Technologies   "For pharmaceuticals and biotechnology, the intent to strengthen biopharma capabilities and regulatory systems is encouraging. However, the Budget stops short of a major push toward easing global capital movement into biotech and life sciences. Going forward, deeper R&D incentives, faster clinical pathways, and smoother cross-border capital access will be critical for India to emerge as a true global hub for innovation-led medicines." Venkat Nelabhotla, Co-Founder, President, and CEO of Vyome Holdings, Inc.   "By prioritising research infrastructure, regulatory capacity and domestic manufacturing, the government has laid the foundation for an innovation-led growth model that will enhance industry competitiveness and reinforce India’s position as a trusted global biopharma manufacturing and research hub, while addressing the growing burden of non-communicable diseases." Nitin Jain, Founder and Managing Director, Iberia Pharmaceuticals   “I commend Finance Minister Nirmala Sitharaman on the Union Budget 2026–27 for recognising the strategic importance of medical tourism in India’s healthcare growth story. India’s medical value travel (MVT) sector has grown steadily over the years, and cities like Hyderabad, Delhi, Chennai, Mumbai and Bengaluru are already well-positioned to scale as global healthcare destinations. With the right execution and private-sector partnership, this initiative can significantly strengthen India’s leadership in global medical tourism." Shaaz Mehmood, Founder, Medijourn Solutions   “Strengthening allied healthcare professionals can be a game-changer for India’s healthcare system. India currently has above 8.4 allied health professionals per 10,000 people, well below the desired level of 14-16 (as per WHO standards). By expanding training capacity, standardising certification, and improving deployment of allied professionals such as lab technicians, physiotherapists, radiographers and paramedics, the reform directly improves access, especially in rural and underserved areas where doctors are scarce." Satyam Shivam Sundaram, Partner, Government and Public Sector, EY India   "As genomics and data-driven science increasingly underpin drug discovery, clinical research, and precision healthcare, the measures announced in the Budget will help strengthen India’s potential to emerge as a globally competitive biopharma and healthcare innovation hub. They also encourage deeper collaboration across industry, academia, and healthcare systems.” Amitabh Rath, Director, Finance Shared Services, Illumina   "The proposal to develop regional medical hubs in partnership with the private sector can reinforce India’s position as a global medical value destination while strengthening preventive, rehabilitative and continuum-of-care models within the country. Strengthening district hospitals through a 50% increase in emergency and trauma care capacity, alongside the establishment of a second NIMHANS and regional mental health apex centres, addresses critical gaps in last-mile and mental healthcare." Dr Devi Prasad Shetty, Founder and Chairman, Narayana Health   "The Union Budget this year is not merely an annual financial exercise; it is a vision statement for India@2047. In my view, this is a forward‑looking budget that lays down far‑reaching, generational‑change policies. Its provisions clearly speak to a Bharat that a three‑year‑old child today will step into as an adult. The thinking is long‑term, structural, and transformative — and that is its greatest strength." Purvesh Shelatkar, Designated Partner and part of the Investment Team at Shrimad Bhagwat Asset Management, and Executive Director at RoseMerc   "The Union Budget 2026–27 signals a clear intent to strengthen India’s clinical research and life sciences ecosystem. As this ecosystem evolves, evidence generation cannot remain limited to trials alone. Indian medical journals, continuous medical education, and real-world data will be equally important in translating research into everyday clinical practice especially in a country as diverse as India. There is also a need to strengthen India’s own platforms for scientific publishing, doctor education, and patient awareness so that India-specific evidence is generated, interpreted, and disseminated locally." Nilesh Aggarwal, Founder, Medtalks   "We appreciate government’s emphasis on strengthening CDSCO and advancing a more predictable, science-led regulatory framework. Aligning regulatory processes with global standards—while expanding India’s clinical research capabilities —will help bring medical innovation to India faster, improve timely patient access to new therapies, and reinforce India’s position as a trusted global life-sciences hub.” Winselow Tucker, President & General Manager, Eli Lilly and Company (India)   “This budget is a quiet but powerful acknowledgement that India’s healthcare future lies beyond hospitals. The government’s focus on building a geriatric care ecosystem and training 1.5 lakh caregivers signals a structural shift towards aging-in-place, home healthcare, and long-term care—areas that founders in AgeTech have been working on for years. This is the first time caregiving is being recognised as national healthcare infrastructure.” Varun Gupta, Founder & CEO, Zorgers Home Healthcare   "While nutraceuticals didn’t receive headline tax relief, the deeper enablers—biopharma-led R&D, AYUSH institutional strengthening, trade facilitation, and manufacturing incentives—create a structurally positive runway."  Amit Srivastava, Founder and Chief Catalyst of Nutrify Today   "Biopharma SHAKTI sets the foundation for India’s emergence as a global hub for biologics and biosimilars. As this ecosystem matures, the pharma packaging industry will play a critical enabling role—advancing high-performance, compliant and sustainable packaging solutions that support product integrity, regulatory confidence and export competitiveness across global markets." Thimmaiah, MD & CEO, Manjushree Technopack   "The Government’s continued focus on rare diseases also highlights the role of early and accurate diagnosis in managing and treating these disorders and genomics will play a critical role here. We believe that this budget is a step ahead in recognising India’s scientific and technological capabilities to drive the nation’s progress.” Surajit Chakrabartty, CFO, MedGenome Labs   ]]> <![CDATA[Biopharma Shakti proposal with total outlay of Rs 10,000 Cr]]> https://biospectrumindia.com/news/95/27262/biopharma-shakti-proposal-with-total-outlay-of-rs-10000-cr.html https://biospectrumindia.com/news/95/27262/biopharma-shakti-proposal-with-total-outlay-of-rs-10000-cr.html Sun, 01 Feb 2026 00:00:00 +0530 The Union Budget for 2026-27 was presented by the Finance Minister Nirmala Sitharaman on 1st February 2026. With an aim to develop India as a global biopharma manufacturing hub, the Union Budget has proposed the Bioforma Shakti (Strategy for Modernising Health Services through Knowledge, Technology and Innovation) programme. Under this, Rs 10,000 crore has been earmarked for the next five years. The programme will create an ecosystem for production of biologicals, products and bio-drugs domestically. As per the budget, three new National Institutes of Pharmaceutical Education and Research (NIPERs) with a focus on Biopharma, will be built, alongside upgradation of seven existing institutions. The budget has also proposed creation of a network of more than one thousand recognised Indian clinical trial sites. The Union Budget also proposes to strengthen the Central Drugs Standard Control Organisation to meet global standards and for timely approval through a dedicated scientific review cadre and experts. Also, basic customs duty will be waived on 17 cancer medicines, with 7 individual export of drugs for additional rare diseases to be exempted from tax.   "Under the Biopharma Shakti initiative, the government has proposed an allocation of Rs 10,000 crore over the next five years. This will increase domestic production of advanced biologicals and biosimilars. The establishment of three new institutes and upgradation of seven existing institutions will usher in a new era of growth, innovation and global competitiveness for India's pharmaceutical sector. Three new Dedicated Chemical Parks in the States will increase domestic chemical production.” Union Minister for Chemicals and Fertilizers J P Nadda   “By placing biopharma among the seven strategic frontier sectors and launching Biopharma Shakti with an outlay of Rs10,000 crore over five years, the Union Budget makes a decisive investment in India’s health and innovation future. As India’s disease burden shifts toward cancer, diabetes and autoimmune disorders, biologics and biosimilars will be central to improving longevity and quality of life. This initiative—spanning manufacturing scale-up, global-grade regulation, new NIPER institutions and a nationwide clinical trials network—can firmly position India as a global biopharma manufacturing hub.” Kiran Mazumdar Shaw, Chairperson, Biocon Group   "The Union Budget 2026 marks an important milestone for both biotech and biopharma ecosystem. With significant investments fostering innovation, upskilling and technology adoption, participation by both domestic and international players will bolster manufacturing infrastructure. The emphasis on expanded research, clinical trials, regulatory reforms and the creation of a network of 1,000 accredited clinical trial sites positions India to move up the value chain as a high-impact biotech innovation hub, with the potential to improve treatment options across cancer, autoimmune and metabolic conditions." Dr Priya Kapoor G. Hingorani, Managing Director, Miltenyi Biotec India and VP APAC    "The addition of new NIPERs and the upgrading of existing ones will expand opportunities for advanced scientific education and skills development, building the talent pipeline essential for innovation-led growth. Recognising the rising burden of non-communicable diseases, particularly cancer, the budget also provides direct relief for patients by exempting basic customs duty on 17 cancer drugs and medicines and extending import duty exemptions to seven additional rare diseases. Combined with regulatory simplification through central–state coordination, these measures are set to strengthen India’s biopharma ecosystem while ensuring patients in India and across the world continue to have access to affordable, high-quality medicines. We look forward to studying the detailed budget to further understand its impact on the pharmaceutical sector." Satish Reddy, Chairman, Dr. Reddy’s Laboratories Limited   "The thrust on Lifesciences is a welcome step as the Indian Lifesciences Sector looks at building capabilities for leadership and growth in the future. The Biopharma Shakti programme heralds a long-term vision that can catapult India to the next orbit of growth." Dr Sharvil Patel, Managing Director, Zydus Lifesciences      ]]> <![CDATA[Novo Medi Sciences launches next-gen Varicella Vaccine built on advanced formulation]]> https://biospectrumindia.com/news/95/27222/novo-medi-sciences-launches-next-gen-varicella-vaccine-built-on-advanced-formulation.html https://biospectrumindia.com/news/95/27222/novo-medi-sciences-launches-next-gen-varicella-vaccine-built-on-advanced-formulation.html Fri, 23 Jan 2026 00:00:00 +0530 Mumbai-based Novo Medi Sciences (Novo Group) has announced the launch of NEXIPOX PLUS®, the most recent innovation in Varicella vaccine since decades. NEXIPOX PLUS® has been developed with a clear focus on addressing the unique clinical, environmental, and operational needs of Indian patients and healthcare settings, making Novo Medi Sciences the only company to proactively upgrade varicella vaccine specifically for India. Live attenuated varicella vaccines are inherently thermolabile, making formulation stability and potency retention critical to ensuring effective immunisation outcomes. Recognising the challenges posed by real-world Indian conditions, NEXIPOX PLUS® has been developed with 2X trehalose-based stabiliser system, representing a significant evolution in formulation that are result oriented. By replacing conventional stabilisers such as gelatin and mannitol, the formulation enhances viral stability, preserves potency, and significantly reduces the risk of allergic reactions and antigen crystallisation-related issues, supporting more reliable vaccine performance across storage, handling, and administration.  The prevalence of chickenpox remains high in India, and the introduction of NEXIPOX PLUS® aligns with broader public health goals of reducing disease burden and improving vaccination compliance. Designed with affordability, scalability, and operational reliability in mind, the vaccine supports adoption in private practice and strengthens the overall immunisation ecosystem. NEXIPOX PLUS® is approved by the Drugs Controller General of India (DCGI) for use from 12 months of age. Backed by patented technology across 156 countries, the product reflects strong global regulatory readiness, with international expansion strategies being evaluated based on public health needs and sustainable supply considerations. ]]> <![CDATA[Serum Institute of India to make up to 100,000 investigational Oxford Rift Valley fever vaccine doses]]> https://biospectrumindia.com/news/95/27179/serum-institute-of-india-to-make-up-to-100000-investigational-oxford-rift-valley-fever-vaccine-doses.html https://biospectrumindia.com/news/95/27179/serum-institute-of-india-to-make-up-to-100000-investigational-oxford-rift-valley-fever-vaccine-doses.html Wed, 14 Jan 2026 00:00:00 +0530 With support from the epidemic preparedness organisation Norway-based Coalition for Epidemic Preparedness Innovations (CEPI), Serum Institute of India (SII), part of Cyrus Poonawalla group, the world's largest vaccine manufacturer, has entered into a licensing arrangement with the University of Oxford to create the largest-ever reserve of an investigational Rift Valley fever vaccine ready for testing. The collaboration comes amid a deadly outbreak of the mosquito-borne disease in Senegal and Mauritania.  Under the agreement SII will manufacture up to 100,000 doses of the University of Oxford’s investigational vaccine candidate, ChAdOx1 RVF. An initial 10,000 doses are planned to be used in a potential upcoming clinical trial assessing the safety and immunogenicity of the vaccine candidate in outbreak-affected areas. The remaining doses will be stored as an investigational reserve available for clinical testing to generate further evidence in  future outbreaks.   In a major milestone for rapid vaccine production, SII has already filled and labelled 12,000 vials of the ChAdOx1 RVF vaccine just 16 days after receiving the essential ingredients. ChAdOx1 RVF is among the most advanced vaccine candidates being developed to protect people against Rift Valley fever. Findings from a new vaccine trial could add to clinical research already taking place on ChAdOx1 RVF in Kenya and bring the world closer to the first licensed human Rift Valley fever vaccine. Rift Valley fever mainly affects livestock, however people have fallen ill in Africa and the Middle East after coming into contact with infected animals or being bitten by infected mosquitoes. ]]> <![CDATA[Valneva and Serum Institute of India discontinue Chikungunya vaccine license agreement]]> https://biospectrumindia.com/news/95/27144/valneva-and-serum-institute-of-india-discontinue-chikungunya-vaccine-license-agreement.html https://biospectrumindia.com/news/95/27144/valneva-and-serum-institute-of-india-discontinue-chikungunya-vaccine-license-agreement.html Tue, 06 Jan 2026 00:00:00 +0530 France-based Valneva SE, a specialty vaccine company, and Serum Institute of India (SII), a Cyrus Poonawalla Group company, have mutually agreed to discontinue their license agreement for Valneva’s single-shot chikungunya vaccine. Valneva´s strategic intent in regaining full rights is to assume direct control over its supply chain and commercialisation for endemic high-risk countries, thereby accelerating access for regions most affected by the disease.  Supporting access to the vaccine in low-and-middle-income countries (LMICs) falls within the framework of the funding agreement Valneva signed with the Coalition for Epidemic Preparedness Innovations (CEPI) in July 2024 with co-funding from the European Union.   Since the re-emergence of the virus, Chikungunya virus (CHIKV) has now been identified in over 110 countries in Asia, Africa, Europe and the Americas. Between 2013 and 2023, more than 3.7 million cases were reported in the Americas and the economic impact is considered to be significant. The medical and economic burden is expected to grow with climate change as the mosquito vectors that transmit the disease continue to spread geographically. As such, the World Health Organization (WHO) has highlighted chikungunya as a major public health problem. ]]> <![CDATA[Biofabri and Bharat Biotech ink technology transfer agreement to advance global access to MTBVAC]]> https://biospectrumindia.com/news/95/27110/biofabri-and-bharat-biotech-ink-technology-transfer-agreement-to-advance-global-access-to-mtbvac.html https://biospectrumindia.com/news/95/27110/biofabri-and-bharat-biotech-ink-technology-transfer-agreement-to-advance-global-access-to-mtbvac.html Mon, 22 Dec 2025 00:00:00 +0530 Biofabri, a global human vaccine development company that is part of the Zendal group, and Bharat Biotech International Limited (BBIL), a global leader in vaccine innovation and manufacturing, have announced the signing of a Technology Transfer Agreement. The agreement represents a significant milestone in advancing global efforts to expand equitable access to tuberculosis vaccines in line with World Health Organization (WHO) priorities. Following the signature of the Licensing Agreement in 2022, this new Technology Transfer Agreement reinforces the collaboration and partnership between the two companies. The Technology Transfer process has already begun to ensure BBIL's manufacturing readiness by the time of MTBVAC licensure in India. BBIL will guarantee the production and supply of MTBVAC in more than 70 countries across Africa and Southeast Asia, regions with a high disease burden. MTBVAC has undergone Phase I and II clinical trials in India. The vaccine candidate has demonstrated safety and immunogenicity. Based on these initial results, BBIL is preparing for a pivotal Phase III vaccine efficacy study, which is expected to begin recruiting participants in the first quarter of 2026. Considering the significant disease burden in India, MTBVAC is poised to be a leading candidate in the TB Mukt Bharat initiative championed by th Prime Minister of India. MTBVAC is the only live, attenuated Mycobacterium TB vaccine in the pipeline and the only vaccine that contains the full complement of the original pathogen's antigenic targets. MTBVAC is being developed by Biofabri, in close collaboration with BBIL, IAVI, Fundação Ataulpho de Paiva (FAP), TB Vaccine Initiative (TBVI) and UNIZAR. MTBVAC is being targeted for two key populations: newborns, adolescents and adults—groups for whom there is currently no effective prophylactic vaccine against TB disease.   ]]> <![CDATA[Novo Nordisk launches world’s most prescribed GLP-1 drug Ozempic® in India]]> https://biospectrumindia.com/news/95/27058/novo-nordisk-launches-worlds-most-prescribed-glp-1-drug-ozempic-in-india.html https://biospectrumindia.com/news/95/27058/novo-nordisk-launches-worlds-most-prescribed-glp-1-drug-ozempic-in-india.html Fri, 12 Dec 2025 00:00:00 +0530 Novo Nordisk, a global healthcare company, has announced the launch of Ozempic® (injectable semaglutide) in India. Ozempic® is a once-weekly GLP-1 RA (receptor agonist) indicated as an adjunct to diet and exercise for adults living with uncontrolled type 2 diabetes mellitus (T2DM).   The arrival of Ozempic® in India comes at a crucial time. According to the World Health Organisation’s 2023-24 estimates, India has 101 million (roughly 11.4 % of India’s population) people living with diabetes, making it the second largest diabetes-affected populations in the world after China. The country also has 136 million individuals with prediabetes and 254 million people living with generalised obesity, signalling an accelerating health challenge that requires effective, evidence-based therapies.    “Bringing Ozempic® to India is a major milestone” said Vikrant Shrotriya - Managing Director, Novo Nordisk India. “Backed by global trust, proven clinical excellence & world class quality, reinforced by a robust supply chain, Ozempic® offers Indian doctors an effective treatment choice. Our goal is to provide patients an innovative & accessible therapy that offers improved glycaemic control, meaningful weight management and long-term heart and kidney protection – all delivered through a simple, easy-to-use pen device. This once-weekly treatment demonstrates Novo Nordisk’s ongoing commitment to better health outcomes and chronic disease care.”   Ozempic® is a GLP-1 receptor agonist that helps: Improve glycaemic control and reduce HbA1c Regulate appetite and food intake by acting on areas of the brain that control hunger Support weight loss in people with T2DM Reduce risks of cardiovascular and kidney complications associated with diabetes   Ozempic® is now available in India as 0.25 mg, 0.5 mg and 1 mg in FlexTouch® Pen - an easy-to-use, once-weekly pen device. The multiple dosing strengths support physician-guided titration and long-term diabetes management. ]]> <![CDATA[Biocon to fully integrate Biocon Biologics as wholly owned subsidiary]]> https://biospectrumindia.com/news/95/27032/biocon-to-fully-integrate-biocon-biologics-as-wholly-owned-subsidiary.html https://biospectrumindia.com/news/95/27032/biocon-to-fully-integrate-biocon-biologics-as-wholly-owned-subsidiary.html Sat, 06 Dec 2025 00:00:00 +0530 Biocon Limited has announced a strategic corporate action to fully integrate Biocon Biologics Limited (BBL) as a wholly owned subsidiary into Biocon Limited, subject to applicable approvals. Biocon Limited is constituting a Governance Council chaired by Kiran Mazumdar-Shaw and a Transition and Integration Management Committee, led by Shreehas Tambe, Chief Executive Officer and Managing Director of Biocon Biologics Limited, to ensure a seamless integration. The Strategy Committee, constituted in May 2025, undertook a comprehensive evaluation of multiple strategic options for Biocon Biologics Limited, including an IPO and a merger with Biocon Limited. After careful consideration of key parameters such as strategic alignment, sectoral dynamics, shareholder value creation, and other relevant data, the Committee concluded that full integration of Biocon Biologics Limited with Biocon Limited and making Biocon Biologics Limited a wholly owned subsidiary of Biocon Limited through the acquisition of minority stakes offers the most efficient and value-accretive path forward. Biocon Limited will acquire the remaining stake in Biocon Biologics Limited from Serum Institute Life Sciences, Tata Capital Growth Fund II and Activ Pine LLP through a share swap of 70.28 Biocon shares for every 100 Biocon Biologics shares, at a share price of Rs 405.78 per Biocon share; valuing Biocon Biologics Limited at $5.5 billion. Further, Biocon will acquire the residual stake held by Mylan Inc. (Viatris) for a total consideration of $815 million, of which $400 million will be payable in cash and $415 million through a share swap of 61.70 Biocon shares for every 100 Biocon Biologics shares at a share price of Rs 405.78 per Biocon share. The Board has also approved raising additional capital, of up to Rs 4500 crore ($500 million) through Qualified Institutional Placement (QIP). ]]> <![CDATA[Emerging players lead as India’s private vaccine market grows 12% in MAT Oct 2025: Pharmarack]]> https://biospectrumindia.com/news/95/27015/emerging-players-lead-as-indias-private-vaccine-market-grows-12-in-mat-oct-2025-pharmarack.html https://biospectrumindia.com/news/95/27015/emerging-players-lead-as-indias-private-vaccine-market-grows-12-in-mat-oct-2025-pharmarack.html Fri, 28 Nov 2025 00:00:00 +0530 India’s private vaccine market grew 12% to Rs 2,217 crore in MAT October 2025, driven by strong performances from both established players and fast-rising challengers, according to Sheetal Sapale, Vice President – Commercial at Pharmarack Technologies. Dr. Reddy’s Laboratories led the market with Rs 409 crore and an 18% share, followed by GSK at 16% and Serum Institute at 11%, all posting positive growth except GSK, which continues to show long-term decline with a –9% five-year CAGR. While Biological E and Abbott recorded stable gains, several prominent companies including Mankind, MSD, Panacea and Sun Pharma saw negative growth. Elaborating more on growth of the private Indian vaccine market, Sheetal Sapale said “The vaccine market is showing a healthy growth. This indicates a significant rise in preference for Prophylactic therapies (medications taken to prevent diseases). Many adult vaccines have shown a healthy double-digit growth.” The standout story of the year, however, came from emerging players: VHB Life Sciences surged 195%, Eris Lifesciences grew 129%, and Plasmagen Biosciences expanded 123%, with Indian Immunologicals, Zydus and Pfizer also delivering strong double-digit increases. Long-term trends further underline the shifting competitive dynamics, with newer entrants such as VHB, Reliance, Eris and Indian Immunologicals showing rapid multi-year expansion. The data reflects a market undergoing diversification, with speciality vaccine demand and portfolio innovation driving momentum beyond the traditional leaders. ]]> <![CDATA[Immunoglobulins power 12% surge in Indian private vaccine market growth: Pharmarack ]]> https://biospectrumindia.com/news/95/27016/immunoglobulins-power-12-surge-in-indian-private-vaccine-market-growth-pharmarack-.html https://biospectrumindia.com/news/95/27016/immunoglobulins-power-12-surge-in-indian-private-vaccine-market-growth-pharmarack-.html Fri, 28 Nov 2025 00:00:00 +0530 The vaccines market reached Rs 2,217.28 crore in MAT October 2025, registering a strong 12% growth. Human Normal Immunoglobulin led the segment at Rs 279.38 crore with 12% growth, followed by Anti-Rabies Vaccine at Rs 263.67 crore (+15%) and Influenza Vaccine at Rs 253.79 crore (+14%), according to Sheetal Sapale, Vice President – Commercial at Pharmarack Technologies. Combination vaccines with tetanus components grew 20% to Rs 199.88 crore, while pneumonia vaccines rose 14% to Rs 171.13 crore. Meningococcal vaccines delivered a robust 24% increase, reaching Rs 146.84 crore. Sheetal Sapale noted impressive surges in Typhoid and Paratyphoid vaccines, which jumped 49% to Rs 72.01 crore, Japanese Encephalitis Vaccine, which grew 95% to Rs 10.73 crore, and Hepatitis Immunoglobulin, which saw the highest spike at 97% to Rs 29.91 crore. Core immunisation products such as DTP combinations, BCG, and MMR also continued to expand steadily. However, she pointed out declines in several categories, including Hepatitis A (–11%), Varicella (–11%), Snake-bite Sera (–12%), Anti-Rabies Sera (–17%), and the DTP–HepB–Influenza multicomponent vaccine, which dropped sharply by 36% to Rs 7.43 crore. Sheetal Sapale noted that post Covid, many hospitals had started stocking vaccines, as many patients preferred hospitals as vaccination centres. That trend has been gradually fading now and sales may be happening more at retailer counters. ]]> <![CDATA[India Hormones Market hits Rs 3,812 crore in Oct 2025: Pharmarack]]> https://biospectrumindia.com/news/95/27017/india-hormones-market-hits-rs-3812-crore-in-oct-2025-pharmarack.html https://biospectrumindia.com/news/95/27017/india-hormones-market-hits-rs-3812-crore-in-oct-2025-pharmarack.html Fri, 28 Nov 2025 00:00:00 +0530 The India Hormones Market recorded steady expansion in MAT October 2025, reaching a value of Rs 3,812 crore with 8% growth and a 5-year CAGR of 9%, according to Sheetal Sapale, Vice President – Commercial at Pharmarack Technologies. While the market remains anchored by large players such as Abbott, Macleods, GSK, Sun Pharma, and Zydus, growth continues to be uneven with strong contributions from leaders and exceptional acceleration from niche specialty companies. Abbott led the market with 22% share and 19% growth, while Sun Pharma delivered one of the strongest performances with 29% growth and a 19% five-year CAGR. At the same time, emerging specialty-driven companies such as Gufic Bioscience (449% growth, 82% CAGR), Centaur (114% growth, 44% CAGR), Troikaa (47% growth, 37% CAGR), and Ferring (25% growth, 19% CAGR) significantly outpaced industry averages, driven by innovation, differentiated hormone therapies, and robust institutional demand. Several mid-tier players, however, faced pressure, including Cipla (–59%), Wockhardt (–47%), Neon (–22%), and La Renon (–11%), with long-term CAGR challenges also visible for Pfizer, Mankind, and Jagsonpal. The Indian hormones market is experiencing significant growth, driven by the hormone replacement therapy (HRT) and human growth hormone (HGH) segments. Key drivers include increasing awareness, a rising diagnosis rate of hormonal disorders, and the growing prevalence of menopausal symptoms and growth hormone deficiencies.  ]]> <![CDATA[Thermo Fisher launches Customer Experience and Bioprocess Design Centres in Hyderabad]]> https://biospectrumindia.com/news/95/26973/thermo-fisher-launches-customer-experience-and-bioprocess-design-centres-in-hyderabad.html https://biospectrumindia.com/news/95/26973/thermo-fisher-launches-customer-experience-and-bioprocess-design-centres-in-hyderabad.html Mon, 24 Nov 2025 00:00:00 +0530 Thermo Fisher Scientific, the world leader in serving science, has inaugurated two new facilities in Hyderabad’s Genome Valley. The Bioprocess Design Centre (BDC), a technology scale-up facility was set up in partnership with Govt. Of Telangana; other partners are Dept. of Biotechnology, Ministry of Science & Technology, Govt. of India under the Biotech Park Project. The Customer Experience Centre (CEC) serves as a collaborative hub for scientists, entrepreneurs, and industry professionals offering hands-on training and co-development opportunities. The centre demonstrates 50+ integrated workflows across 20+ applications in targeted therapeutics like cell and gene therapy, mRNA, oncology, proteomics and analytical sciences featuring Thermo Fisher’s flagship technologies. The centres will support 200 to 250 researchers and scientists annually, providing access to advanced technologies, hands-on training, and collaborative programs that accelerate innovation across bioprocessing, analytical sciences, healthcare, clean energy, and semiconductors. Sridhar Babu, Minister of IT and Industries, Telangana, said, “Telangana’s life sciences sector is on a strong growth trajectory. Partnerships like this will help us achieve our target of Rs 1 lakh crore in life sciences investments by 2030. Thermo Fisher’s new centers bring global capabilities that strengthen our ecosystem. These new facilities will create opportunities for collaboration and skill-building, while reinforcing our vision of making Telangana the life sciences capital of the world.” The Bioprocess Design Centre complements the CEC with bench-to-pilot scale capabilities for biologics and vaccine manufacturing. It enables rapid prototyping, process optimisation and scale-up using single-use systems, supported by laboratories for cell culture, microbial fermentation, purification, and analytical testing.  With a combined investment of Rs 85-90 crore in CEC and BDC, Thermo Fisher continues to build on its investments and growing presence in India.   ]]> <![CDATA[Biological E’s PNEUBEVAX 14® vaccine receives WHO’s pre-qualification]]> https://biospectrumindia.com/news/95/26954/biological-es-pneubevax-14-vaccine-receives-whos-pre-qualification.html https://biospectrumindia.com/news/95/26954/biological-es-pneubevax-14-vaccine-receives-whos-pre-qualification.html Thu, 20 Nov 2025 00:00:00 +0530 Biological E. Limited (BE), a leading Hyderabad-based vaccine and pharmaceutical company, has announced that the World Health Organisation (WHO) has granted Pre-qualification (PQ) status to their 14-valent Pneumococcal Conjugate Vaccine (PCV), PNEUBEVAX 14® (BE-PCV-14). PNEUBEVAX 14® becomes BE’s 11th WHO pre-qualified vaccine. Developed specifically to prevent invasive pneumococcal diseases, PNEUBEVAX 14® protects against infections caused by 14 different Streptococcus pneumoniae serotypes, including serotypes 22F and 33F—two strains not covered by select other PCVs. Administered to infants from six weeks of age, PNEUBEVAX 14® is designed to guard against serious diseases such as pneumonia, meningitis, and sepsis as part of the primary vaccination schedule. Commenting on the WHO pre-qualification, Mahima Datla, Managing Director, Biological E. Limited, said, “This milestone enhances global access to high-quality pneumococcal vaccines and strengthens supply security, particularly for children who need them most. WHO PQ enables broader reach through global immunisation initiatives, and we remain committed to supporting public health partners in delivering affordable, reliable vaccines across India and around the world.” ]]> <![CDATA[India breaks into top 10 in Cytiva’s 2025 Global Biopharma Index]]> https://biospectrumindia.com/news/95/26857/india-breaks-into-top-10-in-cytivas-2025-global-biopharma-index.html https://biospectrumindia.com/news/95/26857/india-breaks-into-top-10-in-cytivas-2025-global-biopharma-index.html Thu, 30 Oct 2025 00:00:00 +0530 Cytiva, a Danaher company and a leader in the life sciences industry, has released the third edition of its Global Biopharma Index. Every two years, Cytiva surveys 1250 biopharma executives across 22 countries and asks them to rate, on a scale of 0 to 10, the biopharma ecosystem across six pillars: supply chain resilience, talent pool, R&D ecosystem, manufacturing agility, government policy and regulation. Sustainability is a new pillar in the 2025 survey.   The latest edition shows India climbing into the top ten globally - rising from fifteenth place in 2023 to tenth in 2025. India’s index score improved to 6.04, up from 5.95 in 2023, marking one of the most notable jumps among emerging economies. The report highlights sustained investment in R&D and a robust generics manufacturing capacity as key contributors to India’s rise.   Manoj Kumar R Panicker, General Manager of South Asia, Cytiva says: “India’s biopharma ecosystem is evolving rapidly, with biosimilars emerging as a strategic lever for global impact. As policy and regulatory frameworks continue to mature, Cytiva is committed to enabling this momentum - through advanced digital technologies, skill development, and partnerships that help scale affordable biologics and sustainable innovation.”   An in-depth look at the six pillars of resilience globally  Supply chain resilience is improving with 55% of executives stating they believe their country’s biopharma supply chains are more robust than 12 months ago. However, more than a quarter surveyed said their supply chain was not equipped to support advanced modalities such as cell and gene therapies. 76% predict that geopolitical volatility will significantly impact their sourcing strategies, while 56% agree that domestic manufacturing of biologics is set to increase dramatically over the next three years.   The talent pool has improved slightly but continues to be a challenge for the biopharma industry. Approximately one third of executives reported severe or critical shortages in key areas associated with advanced drug modalities, such as cell and gene therapies, mRNA, and antibody drug conjugates (ADCs), sustainability, manufacturing, digital, and AI skills.   The R&D Ecosystem pillar is stronger than it was 2023. Countries that score highly on this pillar are more likely to bring therapies to market faster. Collaboration is key to a strong R&D ecosystem and nearly half of respondents said it remains difficult to find high quality partners, such as CROs/CDMOs, academic research institutions, and government labs and think tanks.   Manufacturing agility is central to biopharma’s ability to respond to changing demand. 2025 data shows that many firms lack the ability to scale production quickly. One in four executives surveyed said their organization would be slow or very slow to ramp up manufacturing of hormone-based products, mRNA vaccines, and cell and gene therapies.  Government policies and regulation are critical to the biopharma industry. However, our data shows that many executives struggle with fragmented, unpredictable policy environments. 51% say government policy is inconsistent and 50% say it is now harder to raise capital due to current market conditions.   Sustainability is a strategic priority across many industries but almost half of biopharma executives report that their company fails to achieve its sustainability targets. Nearly two-thirds say their company deprioritises sustainability due to short-term financial pressures and competing business priorities. 34% report talent shortages in sustainability roles.     ]]> <![CDATA[Biocon Biologics and Civica expand partnership to launch private-label insulin glargine in US]]> https://biospectrumindia.com/news/95/26814/biocon-biologics-and-civica-expand-partnership-to-launch-private-label-insulin-glargine-in-us.html https://biospectrumindia.com/news/95/26814/biocon-biologics-and-civica-expand-partnership-to-launch-private-label-insulin-glargine-in-us.html Fri, 17 Oct 2025 00:00:00 +0530 Bengaluru-based Biocon Biologics Ltd. (BBL), a fully integrated global biosimilars company and subsidiary of Biocon Ltd., has announced expansion of its strategic collaboration with Civica, Inc. to include a new Insulin Glargine medicine that will benefit patients in the United States by increasing supply of high-quality affordable insulins. The multi-year transformational agreement between Biocon Biologics and Civica creates an exclusive distributorship arrangement where Biocon Biologics will manufacture and supply Insulin Glargine medicine to Civica, and Civica will commercialize under Biocon Biologics’ existing marketing approval (a private label agreement). Civica will distribute, promote, and sell the medicine in the United States under a separate Civica label and trade dress, and in California, the product will carry the CalRx brand. Biocon Biologics will continue to directly commercialise Biocon Biologics’ own Insulin Glargine-yfgn medicine, which was approved by the US Food and Drug Administration (FDA) in July 2021 as the first interchangeable biosimilar. No technology transfer is involved in the agreement and Biocon Biologics will continue to own the intellectual property and marketing authorization associated with Insulin Glargine. Additional terms of the agreement are not disclosed. This agreement expands the relationship between the two organisations that previously announced that Biocon Biologics will provide Civica with Insulin Aspart drug substance to manufacture in the United States. Insulin glargine-yfgn injection is indicated to improve glycemic control in adult and pediatric patients with diabetes mellitus. Limitations of use: Insulin glargine-yfgn is not recommended for the treatment of diabetic ketoacidosis. ]]> <![CDATA[Serum Institute of India and CEPI supercharge pandemic response preparedness targeting H5N1]]> https://biospectrumindia.com/news/95/26805/serum-institute-of-india-and-cepi-supercharge-pandemic-response-preparedness-targeting-h5n1.html https://biospectrumindia.com/news/95/26805/serum-institute-of-india-and-cepi-supercharge-pandemic-response-preparedness-targeting-h5n1.html Tue, 14 Oct 2025 00:00:00 +0530 Norway-based Coalition for Epidemic Preparedness Innovations (CEPI) is collaborating with Pune-based Serum Institute of India (SII), part of Cyrus Poonawalla Group, to boost pandemic response preparedness using a baculovirus vaccine platform to target H5N1 bird flu as a prototype for a potential Disease X—an as-yet-unknown pathogen with pandemic potential.  Supported by CEPI funding of up to $16.4 million, SII will use its validated baculovirus-based platform to produce and compare two H5 antigens for a recombinant protein vaccine: a wild-type and an AI-optimised, broad-spectrum H5 antigen designed by scientists at Houston Methodist Research Institute. The broad-spectrum approach is designed to elicit immune responses across multiple strains of H5 viruses, rather than just one, making it particularly suited for use in unpredictable outbreak situations.  The collaboration will ultimately pressure-test the baculovirus platform's ability to quickly produce new antigens against H5 viruses, simulating a fast response to a future pandemic threat. The work will also serve as proof of concept for using AI to design vaccine antigens capable of inducing broadly protective immunity. Antigens are proteins that trigger an immune response and are a critical part of an effective vaccine.  Adar Poonawalla, CEO, Serum Institute of India, said, “Our validated baculovirus platform gives us the ability to rapidly develop and produce vaccines for emerging threats. This project will test that readiness in real terms, reinforcing our commitment to pandemic preparedness. The learnings will not only support faster response times but also ensure that effective vaccines can reach vulnerable populations without delay.” ]]> <![CDATA[World Health Organization prequalifies Shanchol® oral cholera vaccine]]> https://biospectrumindia.com/news/95/26778/world-health-organization-prequalifies-shanchol-oral-cholera-vaccine.html https://biospectrumindia.com/news/95/26778/world-health-organization-prequalifies-shanchol-oral-cholera-vaccine.html Tue, 07 Oct 2025 00:00:00 +0530 Shanchol®, the oral cholera vaccine originally developed by Hyderabad-based Shantha Biotechnics, has received prequalification from the World Health Organization (WHO). This milestone enables global procurement agencies such as UNICEF, Gavi, and PAHO to source Shanchol® for use in countries where cholera remains a major public health challenge. “Shanchol® was conceived as an affordable, accessible solution for countries facing repeated cholera outbreaks. The WHO prequalification of vaccine carries forward that founding mission,” said Dr K.I. Varaprasad Reddy, Founder of Shantha Biotechnics. Over the years, close to 40 million doses of Shanchol® have been supplied worldwide through UNICEF-led vaccination campaigns. After production was paused under its former ownership, GCBC Vaccines (formerly Shantha)- has resumed manufacturing, with WHO conducting an on-site inspection and transferring the prequalification. Shanchol® remains the only oral cholera vaccine manufactured in India with WHO prequalification, underscoring India’s critical role in ensuring continuity of global supply. “As part of the founding family of Gland Pharma, I have seen how world-class sterile manufacturing from India can transform global healthcare. By resuming production of Shanchol®, we are bringing the same rigor and reliability to ensure this life-saving vaccine remains available worldwide,” said Dr Ravi Penmetsa, Managing Director, GCBC Vaccines. Shanchol® is a bivalent killed whole-cell oral cholera vaccine, effective against Vibrio cholerae O1 and O139. It has been a cornerstone of UNICEF-coordinated outbreak responses and preventive immunization campaigns, protecting millions of people worldwide. With WHO PQ approval, Shanchol® will continue to be supplied at scale to international demand and to meet country-level immunisation needs.   ]]> <![CDATA[India announces formation of Veterinary Vaccine India Manufacturers Association]]> https://biospectrumindia.com/news/95/26749/india-announces-formation-of-veterinary-vaccine-india-manufacturers-association.html https://biospectrumindia.com/news/95/26749/india-announces-formation-of-veterinary-vaccine-india-manufacturers-association.html Sat, 27 Sep 2025 00:00:00 +0530 In a significant development for India’s animal health sector, veterinary vaccine manufacturers have come together to announce the formation of the Veterinary Vaccine India Manufacturers Association (VVIMA). VVIMA is a non-government, not-for-profit organization that will serve as the collective voice of India’s veterinary vaccine manufacturers. The association will actively collaborate with policymakers, regulators, and stakeholders to shape an enabling ecosystem for innovation, quality manufacturing, and global competitiveness in veterinary vaccines. It envisions positioning India as a global hub for the research, development, and production of animal vaccines. Committed to advancing the One Health concept, VVIMA will play a pivotal role in promoting animal health through effective immunisation strategies, thereby reducing the risk of diseases in animal, the risk of disease transmission between animals and humans as well as towards improving incomes of those involved in animal husbandry in rural India. Meetings were held in Delhi on 25 September between the founding members of VVIMA and the Department of Animal Husbandry & Dairying, with Minister of State Prof. S. P. Singh Baghel; ⁠Secretary Naresh Pal Gangwar; ⁠Animal Husbandry Commissioner Dr Pravin Malik & ⁠Additional Secretary Varsha Joshi to express VVIMA’s commitment. Founding Members: 1.    Biovet Private Limited 2.    Brilliant Bio Pharma Private Limited 3.    Globion India Private Limited 4.    Hester Biosciences Limited 5.    Indian Immunologicals Limited 6.    Indovax Private Limited 7.    Venkateshwara Hatcheries Private Limited     Office Bearers: · President: Rajiv Gandhi, CEO & Managing Director of Hester Biosciences Limited · Vice President: Dr K. Anand Kumar, Managing Director of Indian Immunologicals Limited ]]> <![CDATA[Vidal Health and Serum Institute of India collaborate on HPV vaccine access]]> https://biospectrumindia.com/news/95/26713/vidal-health-and-serum-institute-of-india-collaborate-on-hpv-vaccine-access.html https://biospectrumindia.com/news/95/26713/vidal-health-and-serum-institute-of-india-collaborate-on-hpv-vaccine-access.html Tue, 23 Sep 2025 00:00:00 +0530 In a step towards preventive and digital-first healthcare, Vidal Health (100% subsidiary of Bajaj Finserv Health), India’s second largest TPA service provider and Serum Institute of India (SII), part of Cyrus Poonawalla Group, the world’s largest vaccine manufacturer, today announced a strategic collaboration to support national efforts in cervical cancer prevention and awareness. Starting October 1, 2025, Vidal Health’s platform will be the first-of-its-kind to offer an end- to-end, convenient and cashless experience for HPV vaccine – from digitally booking a doctor’s appointment at a preferred location, to providing consent and receiving certification - all with zero paperwork. The fully managed health programme will provide complete support with timely dosage reminders, adherence monitoring, and efficient network management to ensure continuity of care. Adar Poonawalla, Chief Executive Officer, Serum Institute of India, said, “The HPV vaccine is an important step in preventing cervical cancer, but wider access and awareness are key to its impact. Our collarboration with Vidal Health helps bridge that gap by using technology to deliver the vaccine more efficiently and at scale. This initiative supports our ongoing efforts to make essential vaccines more accessible and improve public health outcomes.” The initiative is significant as it brings together healthcare providers, vaccine manufacturers and national digital platforms such as Aarogya Setu to create a stronger, more connected healthcare ecosystem. The HPV vaccine will be directly available on Vidal Health’s digital platform, ensuring high- quality HPV vaccines with no intermediaries or delays. The platform will enable digital registration, cashless payment and automated tracking of the multi-dose vaccination schedule. Employees at corporates will have the flexibility to get vaccinated at the work premises or at any Vidal Health partner clinic. The entire health programme has been designed to maximise transparency and adoption across user groups with a pricing that is affordable and inclusive. ]]> <![CDATA[Zydus launches India’s first trivalent influenza vaccine for flu protection]]> https://biospectrumindia.com/news/95/26627/zydus-launches-indias-first-trivalent-influenza-vaccine-for-flu-protection.html https://biospectrumindia.com/news/95/26627/zydus-launches-indias-first-trivalent-influenza-vaccine-for-flu-protection.html Tue, 02 Sep 2025 00:00:00 +0530 Ahmedabad-based Zydus Lifesciences has announced the launch of its trivalent influenza (Flu) vaccine VaxiFlu introduced for the first time in India, aligning with the global recommendations of WHO. Flu remains a significant global health concern of seasonal influenza annually, causing 3–5 million cases of severe illness with 290,000 to 650,000 respiratory deaths annually. The disease disproportionately affects vulnerable populations such as infants, the elderly, and individuals with chronic conditions. Vaxiflu - Trivalent Influenza Vaccine (TIV) is recommended for individuals aged 6 months and above. It contains latest, updated strains selected based on WHO’s annual surveillance and recommendations, ensuring optimal protection and precision targeted vaccination for the current season. Speaking on the transition to the trivalent vaccine, Dr Parvaiz Koul, - FRCP (Pulmonary Medicine) (Royal College of Physicians, London), FERS (Fellow of European Respiratory Society) said, “Influenza vaccination remains the most effective preventive measure against seasonal influenza and its complications. Globally, the influenza vaccine is available as quadrivalent and trivalent formulations. Given the global pattern of influenza virus circulation since March 2020, with no circulation of influenza B Yamagata virus, the global regulatory bodies like WHO, CDC, etc, have clearly recommended that B/Yamagata should no longer be a component of the vaccine formulation. Nearly 40 countries, including the US, have already adopted the trivalent vaccine. Under such circumstances, the trivalent influenza vaccine is the most scientific formulation for use. Pertinent to add that influenza B/Yamagata has not been reported from India either and as such trivalent formulation is clearly the way forward. There is no point vaccinating against a virus which is no longer in circulation for the past 5 years.” ]]> <![CDATA[Advances in cervical cancer vaccine- emerging prophylactic and therapeutic strategies ]]> https://biospectrumindia.com/views/95/26630/advances-in-cervical-cancer-vaccine-emerging-prophylactic-and-therapeutic-strategies-.html https://biospectrumindia.com/views/95/26630/advances-in-cervical-cancer-vaccine-emerging-prophylactic-and-therapeutic-strategies-.html Tue, 02 Sep 2025 00:00:00 +0530 Cervical cancer is the fourth most common cancer worldwide. Despite the availability of prophylactic HPV vaccines, recent data indicates that the incidence and mortality of cervical cancer is increasing worldwide. As seen in the figure above, there are a few prophylactic vaccines approved for use. (All vaccines are administered by intramuscular injection) Though these vaccines are highly effective, they provide type restricted immunity and hence incomplete protection. Moreover, there is risk of emergence of viral genotypes not included in the current vaccine formulations. Due to the complex and lengthy manufacturing process, the cost is high and hence not affordable by low-income populations. Hence, there is a critical need for new vaccine formulations with broader spectrum of efficacy and lower costs. The following vaccine developments have taken place in the area of cervical cancer vaccines- Prophylactic vaccines L1 is the major capsid protein in HPV and represents 80% of the viral capsid proteins. Currently,  the US FDA has licenced three L1 based vaccines - Cervarix, Gardasil, and Gardasil 9, that are produced using recombinant DNA technology in various hosts. As the current VLP (virus-like particles) based L1 vaccines are expensive, to reduce the manufacturing cost, simpler expression systems such as E. coli have been employed in various trials. Among the most recent and promising advancements in prophylactic HPV vaccines is the eleven-valent vaccine, (HPV-6/11/16/18/31/33/45/52/58/59/68) developed by the National Vaccine and Serum Institute in China. This vaccine is currently undergoing a Phase 3 clinical trial.  L2 , the minor capsid protein of HPV,  is highly conserved across various HPV types, compared to L1 which is type-specific. Hence L2 based vaccines offer cross protection against multiple HPV genotypes. However, the L2 vaccines have weaker immune responses compared to L1 based vaccines. This is due to the linear structure of L2 and weaker T-helper cell activation. Various preclinical platforms explored for L2 based vaccines include: L2 peptides delivered via bacteriophage VLPs (e.g. MS2, PP7): Bacteriophages can serve as efficient platforms for presenting L2 epitopes to enhance the immune response. L2 infused to hepatitis B core protein adenoviruses DNA and mRNA-based delivery of L2 sequences Recombinant bacteria can also be used to present the L2 protein Only one L2 based vaccine has progressed to clinical trials   Therapeutic cervical cancer vaccine These vaccines aim to stimulate the immune system to eliminate HPV infected cells or pre-cancerous cells. The following key developments have occurred in the area of therapeutic cervical cancer vaccine: AccumTM technology: This newly developed technology triggers a robust immune response  as it allows the antigen to be delivered directly to the antigen presenting cells. This provides enhanced and long lasting protection. Trials done with Accum-E7 (aE7) based protein vaccine in mice by Bikorimana et al found that aE7 vaccination was superior to E7 vaccination alone. This technology has also been tested as a therapeutic vaccination in combination with immune checkpoint inhibitors with encouraging results DNA vaccines and adenovirus vectors: Han et al designed an adenoviral vector encoding a mutant HPV 16 e7 (Ad E7). The recombinant adenovirus is an ideal vector for delivering a therapeutic vaccine against cervical cancer. Trials have shown that DNA based adenoviral vector vaccines can effectively inhibit tumour growth and lead to tumour regression when used in conjunction with other therapeutic modalities. Lacticaseibacillus oral vaccine: Most vaccines for cervical cancer are administered by intramuscular route. Kawana et al investigated the potential of a therapeutic HPV 16 E7 expressing lacticaseibacillus based oral vaccine protein designed to be administered orally. They found that the vaccine had anti-tumour effects in patients with HPV 16 positive high grade cervical intraepithelial neoplasia. Oral route of vaccine administration offers an excellent alternative in the era of vaccine hesitancy and has the potential to improve compliance. mRNA vaccines- Research is ongoing on how mRNA vaccines can be used as a therapeutic treatment for cancer. mRNA vaccine codes for an antigen on the cervical cancer cells. It is encapsulated in lipid nanoparticles to facilitate its delivery to antigen presenting cells. Inside the cell, it travels to the ribosome and is translated into the target protein which is recognized by the antigen presenting cells. The above mentioned strategies hold promise not only for providing broader protection against HPV genotypes but also improve the global vaccine coverage and compliance. Further trials are needed to study the full potential of these novel vaccine approaches.   Navya Mrig, Freelancer ]]> <![CDATA[Pfizer introduces 20-valent Pneumococcal Conjugate Vaccine (PCV20) for adults in India]]> https://biospectrumindia.com/news/95/26514/pfizer-introduces-20-valent-pneumococcal-conjugate-vaccine-pcv20-for-adults-in-india.html https://biospectrumindia.com/news/95/26514/pfizer-introduces-20-valent-pneumococcal-conjugate-vaccine-pcv20-for-adults-in-india.html Mon, 11 Aug 2025 00:00:00 +0530 Pfizer has announced the launch of its next-generation 20-valent pneumococcal conjugate vaccine (PCV20) for adults in India. With broader serotype coverage, Pfizer’s vaccine marks a significant advancement in protection against pneumococcal disease in adults. Pfizer’s vaccine helps protect against clinically relevant 20 serotypes responsible for a majority of invasive and non-invasive pneumococcal disease. It enables timely and proactive protection for all adults, including those living with chronic conditions. PCV20 will be available as a single shot vaccine and those vaccinated with PCV20 may not need a second dose. Meenakshi Nevatia, Managing Director, Pfizer Ltd., India, said, “We are excited to launch PCV20, our 20-valent pneumococcal conjugate vaccine, in India. We believe this vaccine, with its broad coverage of 20 pneumococcal disease serotypes, will address the increasing need for adult immunisation in our country.” Adults over 50 years of age, as well as individuals with comorbidities such as asthma, COPD (Chronic Obstructive Pulmonary Disease), chronic kidney disease, and diabetes, face a higher risk of developing pneumococcal infections, which can result in complications, hospitalisation, and even death. Timely immunisation is critical to reducing the risk of severe illness, hospitalisation, and mortality caused by pneumococcal disease. Vaccination with PCVs are considered one of the most effective public health tools for reducing the burden of pneumococcal disease. The introduction of PCV20 in India strengthens Pfizer’s longstanding commitment to preventive health and builds on 25 years of leadership in pneumococcal vaccine innovation. ]]> <![CDATA[Agilent opens Experience Centre in Hyderabad to support India’s global biopharma ambitions]]> https://biospectrumindia.com/news/95/26459/agilent-opens-experience-centre-in-hyderabad-to-support-indias-global-biopharma-ambitions.html https://biospectrumindia.com/news/95/26459/agilent-opens-experience-centre-in-hyderabad-to-support-indias-global-biopharma-ambitions.html Tue, 29 Jul 2025 00:00:00 +0530 Agilent Technologies, a global leader in life sciences, diagnostics, and applied chemical markets, has announced the inauguration of its new Biopharma Experience Centre in Hyderabad, Telangana. The facility marks a significant investment in India’s rapidly growing life sciences ecosystem and reflects Agilent’s long-term commitment to advancing biopharmaceutical innovation both locally and globally. The centre was inaugurated by Duddila Sridhar Babu, Minister for Information Technology, Electronics, Communications, and Industries, Government of Telangana, in the presence of Agilent President and CEO Padraig McDonnell, along with senior leaders from India’s pharmaceutical and biopharma sectors. The new Agilent Biopharma Experience Centre in Hyderabad presents a major opportunity to accelerate the city’s leadership in life sciences and healthcare innovation. Designed to support the full drug development journey, the center brings together advanced lab technologies, expert training, and regulatory-ready workflows to help researchers, scientists, and companies develop high-quality, life-saving medicines faster and more efficiently. It offers end-to-end solutions across key modalities such as chromatography, mass spectrometry, cell analysis, and lab informatics, allowing companies to simulate real lab environments, test for quality and compliance, and co-create market-ready solutions tailored to both Indian and global needs. “India is a strategic growth market for Agilent, and Hyderabad is at the forefront of biopharma innovation,” said Padraig McDonnell, CEO, Agilent Technologies. “Our future will be defined by continued innovation and a relentless focus on our customers. This new center reflects our commitment to delivering integrated solutions that help bring life-changing therapies to market faster and more efficiently. It also reinforces our support for the ‘Make-in-India’ initiative by empowering local innovation, nurturing talent, and enabling scalable, affordable, and sustainable solutions.” The centre is designed to address critical gaps in analytical capabilities and regulatory readiness for biopharma companies. It will serve as a hub for innovation and collaboration, supporting the development of biologics, biosimilars, and precision medicine. Duddila Sridhar Babu, Minister for Information Technology, Electronics, Communications, and Industries, Government of Telangana said, “Hyderabad has emerged as a complete healthcare and life sciences ecosystem—from drug discovery and clinical trials to world-class hospitals and affordable, high-quality patient care. We are proud to host eight of the top ten global pharma companies, five of India’s leading healthcare chains, and over 230 USFDA-approved manufacturing facilities. Contributing nearly one-third of India’s pharmaceutical production and 40% of bulk drug exports, Telangana is making a strong impact both nationally and globally. With a strong talent base and a clear focus on innovation, we are building a future-ready healthcare system. The launch of the Agilent Biopharma Experience Centre is a significant milestone in strengthening Telangana’s position as a global leader in life sciences, and a valuable addition to our expanding innovation-driven ecosystem.”   ]]> <![CDATA[Scaling CAR-T for India: How ScaleReady’s G-Rex grant is empowering Immuneel Therapeutic ]]> https://biospectrumindia.com/interviews/95/26344/scaling-car-t-for-india-how-scalereadys-g-rex-grant-is-empowering-immuneel-therapeutic-.html https://biospectrumindia.com/interviews/95/26344/scaling-car-t-for-india-how-scalereadys-g-rex-grant-is-empowering-immuneel-therapeutic-.html Tue, 08 Jul 2025 00:00:00 +0530 Earlier this year, Immuneel Therapeutics achieved a significant milestone by becoming one of the first Indian companies to receive regulatory approval for the commercial sale of a CAR-T therapy. However, as patient demand surged, Immuneel faced the challenge of scaling its all-in-one manufacturing platform—known for its clinical reliability but limited in cost-effective expansion. Recognising this bottleneck, ScaleReady stepped in with its G-Rex® Grant, selecting Immuneel as a strategic partner in India. Josh Ludwig, Global Director of Commercial Operations at ScaleReady, speaks with BioSpectrum India about how this collaboration marks a turning point in industrial-scale cell and gene therapy (CGT) manufacturing in emerging markets. He delves into how the G-Rex® platform optimises production efficiency, enhances facility throughput, and lays the groundwork for more affordable access to advanced therapies across India and beyond.   What made Immuneel Therapeutics the right fit for this G-Rex® Grant, and how does it reflect ScaleReady's vision for cell and gene therapy in emerging markets like India? Immuneel has received approval from India’s regulatory bodies for commercial production and sale of a CAR-T product earlier this year. The all-in-one-manufacturing platform Immuneel has used to date, to generate the clinical data and manufacture the commercially-approved CAR-T product, is a well-known and widely disseminated all-in-one platform. However, that all-in-one-manufacturing platform is not able to scale out in a cost effective manner, and therefore Immuneel is unable to meet the patient demand for its CAR-T drug. Immuneel recognized that a change of manufacturing platform is needed to enable scaled manufacture, and that the G-Rex platform would enable it to achieve the cost-effective scale out needed meet the demand for its CAR-T drug. Hence, Immuneel Therapeutics was an ideal candidate and ultimately recipient, for a G-Rex grant. How does the G-Rex platform uniquely support industrial-scale CAR-T manufacturing, especially in cost-sensitive geographies like India? All-in-one manufacturing system have the common disadvantage of leaving portions of the system idle for long periods of time. Ultimately that limits throughput, increases cost, including a huge amount of wasted facility space. Prodigy provides a good example of all-in-one manufacturing system deficiencies. As but one example, Prodigy integrates cell separation technology that typically separates T-cells from other cells. The process takes about 2 hours. Thereafter, the T cells are moved into a chamber in the all-in-one-system where cells are typically expanded in quantity for 7 days. Meanwhile, the cell separation technology is completely idle, doing nothing but taking up space during the 7 day expansion period. In a G-Rex centric manufacturing process, no equipment remains idle. While in an all-in-one manufacturing system, the cell separation equipment sits unused while cells are in the expansion phase, a G-Rex process is able to perform T cell isolation for one patient after another, each patient taking 2 hours. With regards to patient throughput, I have included comparisons of each stage here:   During each 8-hour shift of a G-Rex process, cells can be isolated from the apheresis of 4 patients per shift using a G-Rex approach. With one 8-hour shift per day, in 7 days a G-Rex process can initiation drug product manufacturing for 28 patients compared to only 1 patient for Prodigy.   With two 8-hour shift per day, in 7 days a G-Rex process can initiation drug product manufacturing for 56 patients compared to only 1 patient for Prodigy.   With three 8-hour shift per day, in 7 days a G-Rex process can initiation drug product manufacturing for 84 patients compared to only 1 patient for Prodigy. The advantages of G-Rex go far beyond just starting more patient manufacturing process per day in a G-Rex process versus the all-in-one-systems – it also enables a more efficient use of space. During the cell expansion stage, G-Rex can process 48 patients in the amount of space occupied by just one all-in-one manufacturing system. With a projected demand of 200 doses per day, what production and delivery efficiencies does this collaboration aim to unlock in the short and long term? We anticipate the ultimate benefit of the collaboration with be two-fold. First, the cost of CAR-T drug product manufacturing inclusive of labor, burden and material will be merely $18,000 plus the cost of the genetic engineering construct. Second, due to the much higher patient throughput per sq. ft. of facility in comparison to all-in-one-systems, the size of the manufacturing facility will be much smaller than is possible with all-in-one-systems, thereby significantly reducing up-front capital expenditures. What role do you foresee for public-private partnerships in supporting the scalability and affordability of CAR-T in India? Our knowledge in that area is evolving. We are consistently seeing that the governments of low to middle income countries are deeply interested in bringing CAR-T to their citizens, and therefore expect that governments will be eager to reduce the barriers to achieving that objective. Could you share examples from other regions or partners where the G-Rex grant has enabled successful translation of cell therapies from lab to clinic? Through the G-Rex Grant Program, we are collaborating with entities in most parts of the world, including in Asia (India, China, South Korea, Japan, Thailand, Nepal, etc.), Latin America (Mexico, Argentina, Brazil, Chile, etc.), the Middle East (Turkey, Saudi Arabia, Qatar, Israel, UAE, etc.), Oceania (Australia and New Zealand), and much of Western and Eastern Europe.  In fact, about half of our ~300 G-Rex Grants are to entities outside the United States seeking to transition to G-Rex from their current platform.  To us, this represents evidence that those emerging markets value the simplicity, cost- and space-efficiency, and flexibility that the G-Rex approach offers. Are their future plans to expand? Yes - through CellReady, the world’s only G-Rex centric manufacturing facility, we intend to adopt the lean manufacturing efficiencies that were established by entities such as McDonalds to transcend existing CGT manufacturing limitations. That will allow expansion of McDonalds style CGT manufacturing centers globally and result in worldwide dissemination of the world’s most affordable CGT drug products. (ankit.kankar@mmactiv.com ) ]]> <![CDATA[Bharat Biotech to reduce malaria vaccine RTS,S cost to less than $5]]> https://biospectrumindia.com/news/95/26290/bharat-biotech-to-reduce-malaria-vaccine-rtss-cost-to-less-than-5.html https://biospectrumindia.com/news/95/26290/bharat-biotech-to-reduce-malaria-vaccine-rtss-cost-to-less-than-5.html Wed, 25 Jun 2025 00:00:00 +0530 Hyderabad-based Bharat Biotech International Limited (BBIL) and GSK plc have announced their commitment to Gavi, the Vaccine Alliance (Gavi), in the continued roll out of the world’s first malaria vaccine. Bharat Biotech will be reducing the price of RTS.S, developed by GSK, PATH and partners, by more than half, to less than $5 progressively by 2028.  This price reduction is driven by process improvements, expanded production capacity, cost- effective manufacturing, and minimal profit margins. The announcement forms part of pledges to Gavi for its next replenishment phase (Gavi 6.0, 2026-2030) by both companies. RTS,S was the first malaria vaccine recommended by the World Health Organization (WHO) in 2021. Since then, GSK has made significant investments to enhance production capacity and efficiency, and to undertake the planned technology transfer to Bharat Biotech. In parallel, Bharat Biotech has invested over $200 million in new, higher- output manufacturing facilities, product development and technology transfers. These enhancements have enabled a phased reduction in the price of the malaria vaccine, starting immediately and fully realised by 2028, when the transfer of production between the two companies is complete. With Gavi’s support, 12 endemic countries in Africa will have introduced RTS,S through routine immunisation programmes by the end of 2025. This has only been possible through the critical work that GSK has undertaken with Bharat Biotech, PATH, together with the WHO, implementing countries, MedAccess and Gavi, to help deliver access to life-saving malaria prevention for children in endemic countries in Africa.   ]]> <![CDATA[Novo Nordisk announces launch of injectable Semaglutide for weight management in India]]> https://biospectrumindia.com/news/95/26285/novo-nordisk-announces-launch-of-injectable-semaglutide-for-weight-management-in-india.html https://biospectrumindia.com/news/95/26285/novo-nordisk-announces-launch-of-injectable-semaglutide-for-weight-management-in-india.html Tue, 24 Jun 2025 00:00:00 +0530 Novo Nordisk, a leading global healthcare company headquartered in Denmark with over a 100-year legacy of chronic disease care, has announced the launch of Wegovy® (injectable Semaglutide) in India.   Wegovy® - a once-weekly glucagon-like peptide-1 receptor agonist (GLP-1 RA) - is the first and only weight management medication in India indicated for both long-term chronic weight management and reduction in risk of major adverse cardiovascular events in people living with the condition. It is available in five dosing strengths with the convenience of an innovative easy-to-use pen device.   Wegovy® is a prescription-only medication that has the potential to improve the quality of life for millions of Indians living with obesity or overweight. As per the INDIAB study, India has 254 million people with generalised obesity and 351 people with abdominal obesity.   Semaglutide is the active ingredient in both Ozempic® and Wegovy®. While Ozempic® in many countries across the world is indicated for the treatment of adults with insufficiently controlled type 2 diabetes, Wegovy® is indicated for weight management and reducing the risk of major adverse cardiovascular events in adults with established cardiovascular disease and either obesity or overweight. Ozempic® is not yet available in India. It is strongly advised that people with overweight or obesity speak to their doctor for appropriate treatment options.   Vikrant Shrotriya - Managing Director, Novo Nordisk India said, “Obesity is not just a personal health concern—it is a chronic disease and a national epidemic that India cannot afford to ignore. Recognising this, we are proud to announce that we are bringing Wegovy® to Indians as a transformative and evidence-based therapeutic solution with the convenience of a world-class, state-of-the-art pen device. Additionally, we have an India-specific price with the benefit of same price for the first three dosing strengths. With this we are reaffirming our commitment to address India's growing burden of overweight and obesity.”   Wegovy® will be available in a once-weekly innovative pen device in five dose strengths – 0.25 mg, 0.5 mg, 1 mg, 1.7 mg and a maintenance dosing of 2.4 mg. The state-of-the-art pen device provides the convenience of simple administration and precise dosing. ]]> <![CDATA[Boehringer Ingelheim launches next generation innovative three-in-one poultry vaccine in India]]> https://biospectrumindia.com/news/95/26262/boehringer-ingelheim-launches-next-generation-innovative-three-in-one-poultry-vaccine-in-india.html https://biospectrumindia.com/news/95/26262/boehringer-ingelheim-launches-next-generation-innovative-three-in-one-poultry-vaccine-in-india.html Wed, 18 Jun 2025 00:00:00 +0530 Boehringer Ingelheim, a global leader in animal health, has announced the launch of its latest poultry vaccine in India—a single-dose, next-generation solution that provides protection against Bursal, Newcastle and Marek’s disease. This innovative vaccine is designed to address the practical challenges faced by poultry farmers in India, offering early, reliable, and long-lasting immunity with just one administration at the hatchery. With poultry playing a vital role in India’s food supply and rural economy, disease outbreaks remain a serious threat to both productivity and profitability. This new vaccine offers a streamlined approach to disease prevention by reducing the need for multiple field vaccinations, lowering labor requirements, and minimizing bird handling stress—all while maintaining strong disease control across production systems. Dr Vinod Gopal, Country Head-Animal Health, Boehringer Ingelheim India, emphasised the company’s focus on local needs, “We understand the pressure Indian poultry farmers face—from disease control to operational efficiency. This vaccine reflects our commitment to bringing science-led, farmer-focused innovations to the market. By combining protection into a single dose, we are helping farmers enhance productivity, improve bird welfare, and build more resilient operations.” Dr K. S. Prajapati, Former HOD, Dept. of Vet. Pathology, College of Vet. Science, AAU, Anand commented on the significance of this advancement, “Farmers need solutions that are both effective and practical. The evolving disease landscape demands smarter protection strategies. A vaccine that offers early, combined immunity against three major diseases is a valuable tool that helps farmers secure their flocks and reduce reliance on antibiotics.” The vaccine is suitable for broilers, layers, and breeders, and can be administered either in ovo or via subcutaneous injection at the hatchery.   ]]> <![CDATA[Serum Institute of India partners with DNDi to advance development of new dengue treatment]]> https://biospectrumindia.com/news/95/26253/serum-institute-of-india-partners-with-dndi-to-advance-development-of-new-dengue-treatment.html https://biospectrumindia.com/news/95/26253/serum-institute-of-india-partners-with-dndi-to-advance-development-of-new-dengue-treatment.html Tue, 17 Jun 2025 00:00:00 +0530 Pune-based Serum Institute of India (SII), part of Cyrus Poonawalla Group, the world’s largest vaccine manufacturer, and the not-for-profit medical research organization Drugs for Neglected Diseases initiative (DNDi) have signed a Memorandum of Understanding (MoU) to accelerate the clinical development of a monoclonal antibody treatment for dengue that will be affordable and accessible in low- and middle-income countries (LMICs). Through this collaboration, both SII and DNDi will develop a work plan to implement R&D, additional Phase III clinical trials, and access activities, along with a joint strategy to raise necessary funds and resources. Additionally, a joint project team will be formed to advance clinical trials, with the goal of registering and deploying the dengue monoclonal antibody in India and other dengue-endemic countries, provided the studies confirm its safety and efficacy. SII has already conducted pre-clinical studies and Phase I and II clinical trials that show the candidate (formerly VIS513) is safe and effective. Currently, SII is leading the pivotal Phase III clinical trial in India for licensure. SII and DNDi will now work together to conduct additional Phase III trials in other dengue-endemic countries, including Brazil. DNDi will act as the lead partner for these Phase III clinical trials, including trial leadership, sponsorship, and implementation in Brazil and potentially other endemic countries in Southeast Asia. DNDi and SII will lead strategic engagement efforts with the Dengue Alliance, relevant industry stakeholders, and policymakers in low- and middle-income countries. For the DNDi-led trial in Brazil and other countries, SII will provide development background and technical support. Furthermore, SII will be responsible for the manufacture, development, and provision of clinical supplies of the monoclonal antibody candidate. The company will define and execute the regulatory strategy in India and will lead the commercialization of the product in the country.   Image caption- (L-R) Dr André Siquiera, Head of Dengue at DNDi and Sunder Lata A Kavitkar, Company Secretary, Serum Institute of India ]]> <![CDATA[Bharat Biotech to advance GSK's Shigella vaccine development for severe bacterial diarrhoea]]> https://biospectrumindia.com/news/95/26233/bharat-biotech-to-advance-gsks-shigella-vaccine-development-for-severe-bacterial-diarrhoea.html https://biospectrumindia.com/news/95/26233/bharat-biotech-to-advance-gsks-shigella-vaccine-development-for-severe-bacterial-diarrhoea.html Thu, 12 Jun 2025 00:00:00 +0530 Hyderabad-based Bharat Biotech International Limited (BBIL) has partnered with GSK plc for the ongoing development and potential use of the Shigella vaccine candidate, altSonflex1-2-3. The agreement marks a critical step in the advancement of this promising vaccine, targeting Shigellosis, a severe form of bacterial diarrhoea that disproportionately affects children under five in low- and middle-income countries. The in-licensed candidate, altSonflex1-2-3, has already shown encouraging results in early-stage clinical trials. A Phase 1 study conducted in Europe demonstrated a favourable safety profile and strong immune response. Subsequent Phase 2 trials in Africa, including vaccination of 9-month-old infants—the primary target population—reported no safety concerns. Interim results from 2024 confirmed that the candidate met its pre-set immunogenicity goals. The altSonflex1-2-3 vaccine candidate, developed by GSK and now advancing through a strategic collaboration with Bharat Biotech, represents one of the most advanced Shigella vaccine candidates globally. With no licensed Shigella vaccine currently available and rising antimicrobial resistance, this candidate stands out for its broad serotype coverage, innovative Generalized Modules for Membrane Antigens (GMMA)-based platform, and robust early clinical results. It has already demonstrated a strong safety and immunogenicity profile in both European and African trials, including in the primary target population of 9-month-old infants. Now entering Phase 3 trials under Bharat Biotech’s leadership, altSonflex1-2-3 is poised to become the first scalable, affordable, and globally accessible vaccine to combat this urgent public health threat. GSK will continue to support the programme by assisting with clinical trial design, securing external funding, and contributing to the Access and Delivery Plans and commercialisation strategy. GMMA technology is an innovative platform that uses bacterial outer membranes to deliver the O Antigen to the immune system. This novel approach allows for high-yield production with a simple and cost-effective manufacturing process, offering a pathway to create affordable vaccines for underserved populations.   ]]> <![CDATA[Agenus and Zydus Lifesciences enter $141 M strategic collaboration for biologics manufacturing in US]]> https://biospectrumindia.com/news/95/26198/agenus-and-zydus-lifesciences-enter-141-m-strategic-collaboration-for-biologics-manufacturing-in-us.html https://biospectrumindia.com/news/95/26198/agenus-and-zydus-lifesciences-enter-141-m-strategic-collaboration-for-biologics-manufacturing-in-us.html Tue, 03 Jun 2025 00:00:00 +0530 US-based Agenus Inc., a leader in immuno-oncology innovation, has signed definitive partnership agreements with Ahmedabad-based Zydus Lifesciences, including its subsidiaries/affiliates, designed to accelerate clinical development, scale global manufacturing, and expand patient access to botensilimab and balstilimab (BOT/BAL). The strategic collaboration includes an exchange of Agenus’ state-of-the-art biologics CMC facilities in Emeryville, CA and Berkeley, CA for upfront consideration of $75 million; Agenus to receive up to an additional $50 million in contingent payments triggered by BOT/BAL production orders. Zydus, an India-based multinational pharmaceutical company with over 27,000 employees and operations in 55 countries, will launch a BioCDMO business using the facilities as their flagship US sites to provide biologics contract manufacturing services to biopharmaceutical companies globally. Agenus will become Zydus’ first BioCDMO customer through an exclusive manufacturing agreement for BOT/BAL to ensure the combination regimen’s BLA and launch readiness needs. This collaboration enables Agenus to unlock the value of its manufacturing assets and secure strategic capital to drive BOT/BAL toward global regulatory engagement and commercialisation. Agenus will also grant Zydus an exclusive license to develop and commercialize BOT and BAL in India and Sri Lanka, capitalizing on Zydus’ established local market presence and infrastructure. Zydus will pay Agenus a 5 percent royalty on net sales in those countries. ]]> <![CDATA[Bharat Biotech's oral cholera vaccine demonstrates success in Ph III clinical studies]]> https://biospectrumindia.com/news/95/26133/bharat-biotechs-oral-cholera-vaccine-demonstrates-success-in-ph-iii-clinical-studies.html https://biospectrumindia.com/news/95/26133/bharat-biotechs-oral-cholera-vaccine-demonstrates-success-in-ph-iii-clinical-studies.html Wed, 21 May 2025 00:00:00 +0530 Hyderabad-based Bharat Biotech’s Oral Cholera Vaccine Hillchol® has demonstrated success against both Ogawa and Inaba serotypes, proving non-inferior in healthy Indian adults and children, supporting its potential as an effective oral cholera vaccine (OCV). The study findings have been published in the ScienceDirect, Vaccine journal 126998 to assess a double-blind, randomised phase III clinical trial to evaluate safety, immunogenicity, non-inferiority & lot-to-lot consistency of single component oral cholera vaccine Hillchol® in comparison to a comparator vaccine in a diverse participant group of 1,800 individuals, from infants to adults, across 10 clinical sites in India. In this study, participants were divided into three age groups: adults over 18 years, children aged 5 to under 18 years, and infants aged 1 to under 5 years. They were randomised in a 3:1 ratio to receive either Hillchol® or a comparator vaccine. The primary endpoint focused on the proportion of participants achieving >4-fold increase in vibriocidal antibody titres against Ogawa and Inaba serotypes 14 days after two doses. While secondary endpoints included Geometric Mean Titre (GMT) measurements and safety. Hillchol® demonstrated a greater than 4-fold rise in vibriocidal antibodies against both Ogawa (68.3%) and Inaba (69.5%) serotypes, proving non-inferiority to licensed vaccines. Adverse events were mild and comparable between the two vaccines. Dr Krishna Ella, Executive Chairman of Bharat Biotech said, “Cholera is a vaccine-preventable disease that has faced a surge in outbreaks along with a huge shortage of vaccines. The new generation Oral Cholera Vaccine Hillchol®, featuring a simplified single stable O1 Hikojima strain, inducing robust antibodies against both Ogawa and Inaba serotypes, aims to enhance production efficiency and affordability, particularly in lower- and middle-income countries where waterborne diseases continue to pose serious health threats.” Global demand for OCVs is close to 100 million doses a year, and given that only one manufacturer supplies them, there is a global shortage. Bharat Biotech's facilities in Hyderabad and Bhubaneswar have a capacity to produce up to 200 million doses of Hillchol®. ]]> <![CDATA[Zydus invests in Feldan Therapeutics to drive innovation in intracellular drug delivery]]> https://biospectrumindia.com/news/95/26004/zydus-invests-in-feldan-therapeutics-to-drive-innovation-in-intracellular-drug-delivery.html https://biospectrumindia.com/news/95/26004/zydus-invests-in-feldan-therapeutics-to-drive-innovation-in-intracellular-drug-delivery.html Thu, 17 Apr 2025 00:00:00 +0530 Zynext Ventures USA LLC, the venture capital arm of Ahmedabad-based Zydus Lifesciences, has announced its investment in Feldan Therapeutics, a Canada-based early clinical-stage pharmaceutical company pioneering the development of treatments based on intracellular delivery of therapeutics. Feldan's proprietary Shuttle peptide technology enables the efficient and targeted delivery of biomolecules into cells, unlocking new therapeutic possibilities. The company's lead candidate, FLD-103, is administered directly into basal cell carcinoma (BCC) lesions, where the Shuttle peptide facilitates the delivery of a Hedgehog inhibitor to its target within BCC cells. This innovative approach aims to provide BCC patients with a non-surgical treatment option that improves outcomes and significantly enhances their quality of life. Additionally, Feldan is advancing a pulmonary programme that leverages the Shuttle's unique ability to transport biomolecules into hard-to-deliver lung cells to address the unmet and growing medical needs of patients with respiratory diseases. Jay Kothari, Director of Zynext Ventures, highlighted, "Feldan's platform has the potential to transform intracellular delivery and pioneer next-generation therapeutics, aligning with the disruptive innovations we aim to add to our portfolio." ]]> <![CDATA[Biocon Biologics gets US FDA approval for Biosimilar Bevacizumab, expanding oncology portfolio]]> https://biospectrumindia.com/news/95/25972/biocon-biologics-gets-us-fda-approval-for-biosimilar-bevacizumab-expanding-oncology-portfolio.html https://biospectrumindia.com/news/95/25972/biocon-biologics-gets-us-fda-approval-for-biosimilar-bevacizumab-expanding-oncology-portfolio.html Thu, 10 Apr 2025 00:00:00 +0530 Biocon Biologics Ltd (BBL), a subsidiary of Bengaluru-based Biocon Ltd has announced that the US Food and Drug Administration (US FDA) has approved Jobevne (bevacizumab-nwgd), a biosimilar Bevacizumab for intravenous use. Jobevne, a recombinant humanised monoclonal antibody used to treat several different types of cancer, is a biosimilar to the reference product Avastin (bevacizumab). Jobevne is a vascular endothelial growth factor (VEGF) inhibitor that binds with VEGF and blocks the interaction with its receptors to prevent angiogenesis, combating cancer by restricting blood supply to the tumor. The approval of Jobevne expands Biocon Biologics’ biosimilar oncology portfolio in the United States, which also includes OGIVRI (Trastuzumab-dkst) and FULPHILA (Pegfilgrastim-jmdb). The company also markets Bevacizumab in Europe (approved February 2021) and Canada (approved November 2021) under the name ABEVMY. Shreehas Tambe, CEO & Managing Director, Biocon Biologics Ltd., said, “The US FDA approval of Jobevne (bevacizumab-nwgd) is a significant milestone—our seventh biosimilar approved in the US and a strong addition to our robust oncology portfolio. ]]> <![CDATA[Gennova Biopharma accelerates development of Nipah virus vaccines using mRNA technology]]> https://biospectrumindia.com/news/95/25912/gennova-biopharma-accelerates-development-of-nipah-virus-vaccines-using-mrna-technology.html https://biospectrumindia.com/news/95/25912/gennova-biopharma-accelerates-development-of-nipah-virus-vaccines-using-mrna-technology.html Tue, 01 Apr 2025 00:00:00 +0530 Pune-based Gennova Biopharmaceuticals, a subsidiary of Emcure Pharmaceuticals, is advancing the development of a pathbreaking self-amplifying mRNA (saRNA) vaccine against the deadly Nipah virus. This critical initiative is supported by an expanded partnership with Norway-based Coalition for Epidemic Preparedness Innovations (CEPI), with funding of up to $13.38 million. Gennova will also team up with US-based Houston Methodist Research Institute (HMRI), also a CEPI partner, to use their cutting-edge AI technology to optimize the properties of proteins derived from the virus that could stimulate the immune system and serve as optimal vaccine targets for Gennova to investigate in the lab and in the clinic. Nipah virus belongs to the Paramyxovirus family. It is one of the deadliest pathogens known to infect humans. So far, Nipah outbreaks have been confined to South and Southeast Asia, but the fruit-bat vector is found in large geographical areas across the globe covering a population of more than 2 billion people.  In August 2023, CEPI initially provided up to $3.6 million to support the optimisation of Gennova’s saRNA-platform technology to develop vaccine candidates against unknown pathogenic threats, also referred to as Disease X. The initial tranche of funding was part of CEPI's programme to support novel RNA vaccine platform technologies for emerging and select endemic infectious diseases, which could offer substantial advantages over existing mRNA technologies, such as multivalency, improved immunogenicity, storage and stability, productivity, response time, and cost-of-goods.   ]]> <![CDATA[Eli Lilly explores establishment of Centre of Excellence for insulin therapies in India]]> https://biospectrumindia.com/news/95/25883/eli-lilly-explores-establishment-of-centre-of-excellence-for-insulin-therapies-in-india.html https://biospectrumindia.com/news/95/25883/eli-lilly-explores-establishment-of-centre-of-excellence-for-insulin-therapies-in-india.html Tue, 25 Mar 2025 00:00:00 +0530 Global CEO of Eli Lilly, world's pioneer Insulin manufacturing company, David Ricks called on Union Minister of State (Independent Charge) for Science and Technology; Earth Sciences and Minister of State for PMO, Department of Atomic Energy, Department of Space, Personnel, Public Grievances and Pensions, Dr Jitendra Singh to discuss strengthening partnership, with a focus on Insulin and Non-Communicable Disease (NCD) therapies as well as biomanufacturing. Eli Lilly, a global pharmaceutical giant headquartered in the US, has a significant presence in India through its subsidiary, Eli Lilly and Company (India) Pvt. Ltd. The company imports and markets medicines for diabetes, gastric cancer, lung cancer, breast cancer, osteoporosis, rheumatoid arthritis, and other critical diseases. Its operations also extend to Nepal, Bangladesh, and Sri Lanka through partnerships with local pharmaceutical firms. The talks also covered the establishment of a Centre of Excellence for insulin therapies, as well as clinical trials for advanced treatment options. Eli Lilly’s engagement with India comes at a time when the country is focusing on bolstering its pharmaceutical industry, not just for domestic needs but also as a global supplier. The potential establishment of a Centre of Excellence could serve as a critical step in making insulin therapies more accessible, reinforcing India’s role in combating lifestyle diseases. ]]> <![CDATA[2025 Modi Prix Galien India Award gives recognition to innovations in life sciences]]> https://biospectrumindia.com/news/95/25866/2025-modi-prix-galien-india-award-gives-recognition-to-innovations-in-life-sciences.html https://biospectrumindia.com/news/95/25866/2025-modi-prix-galien-india-award-gives-recognition-to-innovations-in-life-sciences.html Fri, 21 Mar 2025 00:00:00 +0530 The Galien Foundation, a premier global institution dedicated to honouring innovators in life sciences, recently celebrated excellence and innovation in life sciences during the Prix Galien India Forum and second annual Modi Prix Galien Awards in New Delhi. The Prix Galien India Awards Committee, comprised of renowned leaders from the biomedical industry and academia, honoured this year's award winners in the following categories: Best Biotechnology Product- PNEUBEVAX 14 by Biological E Best Academic/Public Sector- Indian Institute of Science Best Medical Technology- Misso Robotic System by Meril Healthcare Best Startup/Digital Health Solution- Inaccel Technologies Jadhav Prataprao Ganpatrao, Union Minister of State for Health and Family Welfare, Government of India, personally distributed the prestigious Modi Prix Galien awards to the awardees. Dr Renu Swarup, Modi Prix Galien India Committee Chair said, "As we move forward, it is crucial that we continue to foster an ecosystem that encourages innovation and collaboration. The future of healthcare depends on our ability to work together towards transformative solutions." ]]> <![CDATA[Bharat Biotech launches India’s only vertically integrated cell and gene therapy, viral production facility at Genome Valley]]> https://biospectrumindia.com/news/95/25860/bharat-biotech-launches-indias-only-vertically-integrated-cell-and-gene-therapy-viral-production-facility-at-genome-valley.html https://biospectrumindia.com/news/95/25860/bharat-biotech-launches-indias-only-vertically-integrated-cell-and-gene-therapy-viral-production-facility-at-genome-valley.html Thu, 20 Mar 2025 00:00:00 +0530 Bharat Biotech International Limited (BBIL), a pioneer in affordable indigenous vaccine development and manufacturing, has announced the launch of India’s only vertically integrated, purpose-designed Cell & Gene Therapy (CGT) Infrastructure & Viral Vector Production Facility at Genome Valley, expanding its expertise from vaccine innovation to leading-edge regenerative and personalised therapies that promise hope for millions. This facility ushers in a new era of gene and cell therapies to tackle scientific challenges such as targeted gene expression, immune system modulation, and long-term cell survival. The work will span from boosting immune responses against cancer to ensuring that therapeutic proteins are safely accepted in patients with genetic diseases like hemophilia. The 50,000-square-foot dedicated state-of-the-art CGT facility represents the next milestone in BBIL’s long-standing mission to deliver targeted, life-saving treatments that address unmet clinical needs globally by concentrating on critical conditions such as hematological malignancies and inherited blood disorders. Outlining the purpose behind establishing India’s only vertically integrated cell and gene therapy facility, Dr Krishna Ella, Executive Chairman, Bharat Biotech said, “Gene and cell therapies represent some of the most intricate, scientifically advanced treatments available today, involving sophisticated processes that require expertise in precise genetic manipulation and specialised manufacturing capabilities." Multiple specialised teams, spanning process development, production, quality assurance, and quality control, will collaborate under one roof to drive the clinical translation of novel therapies. Full-scale operations are on track to commence as the facility finalises regulatory approvals and completes the remaining build-out phases. ]]> <![CDATA[Zydus invests in Illexcor Therapeutics to advance novel oral therapy for sickle cell disease]]> https://biospectrumindia.com/news/95/25825/zydus-invests-in-illexcor-therapeutics-to-advance-novel-oral-therapy-for-sickle-cell-disease.html https://biospectrumindia.com/news/95/25825/zydus-invests-in-illexcor-therapeutics-to-advance-novel-oral-therapy-for-sickle-cell-disease.html Thu, 13 Mar 2025 00:00:00 +0530 Zynext Ventures USA LLC (Zynext Ventures), the venture capital arm of Ahmedabad-based Zydus Lifesciences, has announced its investment in US-based Illexcor Therapeutics, a pioneering biopharmaceutical company developing next-generation oral therapies for sickle cell disease (SCD).  Illexcor is developing a first-in-class oral drug that directly targets the root cause of SCD. Their lead asset, currently in preclinical development, is designed to bind to Hemoglobin S and effectively block polymerisation and sickling, offering the potential for disease-modifying clinical benefits. Speaking on the development, Dr Sharvil Patel, MD of Zydus Lifesciences, said, "This investment reflects our commitment to patients battling rare and orphan diseases. Recognizing the profound impact of sickle cell disease on patients' lives, we are pleased to support Illexcor in their efforts to develop a novel therapeutic solution addressing this critical unmet medical need." Emphasising the strategic significance of the investment, Jay Kothari, Director of Zynext Ventures said, "This investment is consistent with Zynext Ventures' objective of identifying and fostering transformative early-stage healthcare innovations. Beyond the financial backing, Zynext Ventures will leverage its unique data analytics and strategic expertise to accelerate Illexcor's path to delivering this potentially life-changing therapy globally." Andrew Fleischman, CEO of Illexcor stated, "We are excited to partner with Zynext Ventures to advance our lead drug ILX002 into clinical trials later this year. We are hopeful that ILX002 will be a transformative treatment not only for SCD patients in the U.S. but also for millions around the globe. Zynext Ventures and Zydus Lifesciences are in a strategic position to help us achieve these goals." Sickle cell disease is a devastating and debilitating genetic condition that affects up to 10 million people worldwide. The disease continues to severely impact quality of life and longevity. Highly efficacious oral drug therapies are urgently needed to manage this condition on a global scale. ]]> <![CDATA[Biocon Biologics and Civica, Inc. collaborate to expand insulin Aspart access in US]]> https://biospectrumindia.com/news/95/25794/biocon-biologics-and-civica-inc-collaborate-to-expand-insulin-aspart-access-in-us.html https://biospectrumindia.com/news/95/25794/biocon-biologics-and-civica-inc-collaborate-to-expand-insulin-aspart-access-in-us.html Thu, 06 Mar 2025 00:00:00 +0530 Bengaluru-based Biocon Biologics Ltd (BBL), a fully integrated global biosimilars company and subsidiary of Biocon Ltd, and Civica, Inc., a not-for-profit generic drug and pharmaceutical company founded in 2018 to address and resolve life-saving drug shortages and affordability, have announced a strategic collaboration agreement to expand access and affordability of Insulin Aspart in the United States (US). Under the terms of the agreement, Biocon Biologics will supply Insulin Aspart drug substance to Civica, Inc., who will use the drug substance to produce Insulin Aspart drug product, a rapid-acting insulin analog, at its manufacturing facility in Petersburg, Virginia. Civica will commercialise the medicine for patients in the United States, after completion of development work and clinical trials. No technology transfer is involved in the agreement. This collaboration is in addition to Biocon Biologics’ own Insulin Aspart Drug Product for the United States which is currently under US Food and Drug Administration (FDA) review. There are 38.4 million people with diabetes in the United States, approximately 11.6 percent of the total population, with nearly a quarter being undiagnosed. An additional 97.6 million Americans have been identified as prediabetic. ]]> <![CDATA[Zydus Lifesciences launches ANVIMO for transplant patients]]> https://biospectrumindia.com/news/95/25787/zydus-lifesciences-launches-anvimo-for-transplant-patients.html https://biospectrumindia.com/news/95/25787/zydus-lifesciences-launches-anvimo-for-transplant-patients.html Wed, 05 Mar 2025 00:00:00 +0530 Ahmedabad-based Zydus, a leading, discovery-based, global lifesciences company, has announced the launch of ANVIMO (Letermovir), a breakthrough in the prevention of Cytomegalovirus (CMV) infection for haematopoietic stem cell transplant (HSCT) and kidney transplant patients. ANVIMO will be available in dosages of 240 mg and 480 mg. CMV infection remains one of the most serious complications in transplant patients, often leading to graft failure, decreased survival and prolonged hospital stays. Traditional CMV treatments, such as ganciclovir and valganciclovir, have notable limitations, including toxicity and bone marrow suppression. Letermovir provides a safer, well-tolerated, and effective alternative, offering superior safety and reduced side effects while improving transplant outcomes. Transplantation is a life-saving but financially burdensome procedure in India. The high cost of post-transplant care, particularly CMV prophylaxis, adds to the burden. Until now, innovator Letermovir 240 mg was imported at Rs 5+ lakh per month, severely limiting access. With the launch of ANVIMO, Zydus has significantly reduced the cost by 91% of the innovator price, making treatment of CMV prophylaxis significantly more affordable for Indian patients. ANVIMO has established bioequivalence with the reference drug, ensuring quality at a fraction of the cost. With ANVIMO, Zydus Lifesciences is transforming CMV prophylaxis in India, ensuring that more transplant patients receive timely, effective, and affordable care, ultimately improving survival rates and quality of life. ]]> <![CDATA[Shah Brothers announces expansion to revolutionise single use manufacturing capabilities]]> https://biospectrumindia.com/news/95/25707/shah-brothers-announces-expansion-to-revolutionise-single-use-manufacturing-capabilities.html https://biospectrumindia.com/news/95/25707/shah-brothers-announces-expansion-to-revolutionise-single-use-manufacturing-capabilities.html Tue, 04 Mar 2025 00:00:00 +0530 Shah Brothers, a trusted partner in single use solutions, is constructing a new manufacturing facility in Vadodara. The three state-of-the art buildings, covering 87,220 sq. ft, enhances manufacturing capacity for single use technology products in India. The advanced ISO Class VII Inteviz facility will transform single-use assembly manufacturing with superior processes ensuring flexibility, compliance, and scalable production. In addition, indigenous manufacturing of fluid handling solutions will ensure increased production capacity and tailored solutions to meet growing industry demands. “This milestone strengthens our ability to serve our Indian and global partners with enhanced momentum, customized solutions, and unmatched reliability.” said company director Nishant Shah. As the company embarks on this exciting journey, it reaffirms its commitment to excellence. As the industry needs growth, Shah Brothers continues to supply the biopharma and biotech industries with a range of innovative products, from upstream to fill-finish, including our flagship products under Inteviz customised single-use assemblies & Floviz brand, as well as connectors, tubing, pumps, mixers, and other single-use solutions. For more details, click here ]]> <![CDATA[Zydus to develop world’s first combination vaccine to offer protection against shigellosis and typhoid for children]]> https://biospectrumindia.com/news/95/25780/zydus-to-develop-worlds-first-combination-vaccine-to-offer-protection-against-shigellosis-and-typhoid-for-children.html https://biospectrumindia.com/news/95/25780/zydus-to-develop-worlds-first-combination-vaccine-to-offer-protection-against-shigellosis-and-typhoid-for-children.html Tue, 04 Mar 2025 00:00:00 +0530 Ahmedabad-based Zydus Lifesciences has announced its focus on the development of a combination vaccine against shigellosis and typhoid. This combination vaccine, being developed for the first time in the world, underscores India’s innovation capabilities with the potential to provide protection against deadly enteric diseases - Typhoid and Shigella. Zydus will carry out early-stage development, animal immunogenicity studies and regulatory preclinical toxicology studies for this combination vaccine. The project is expected to get underway in March 2025, and is being supported by the Gates Foundation. Zydus will collaborate with a partner for the research and co-development of a combination vaccine using Zydus’ WHO prequalified Typhoid conjugate vaccine (ZyVac TCV) and Shigella Vaccine from Zydus’ partner. Vaccination remains the most effective way of preventing and controlling the disease. The TCV-Shigella combination vaccine aims to protect children below 5 years against shigellosis, a diarrhoeal disease caused by the Shigella bacteria and typhoid fever, caused by salmonella bacteria in areas where both the diseases are endemic. This combination of vaccines, if found successful, will safeguard children against two lethal enteric diseases of global relevance and potentially offer a viable solution in a scenario where childhood immunisation schedules are becoming increasingly crowded, expensive, and unsustainable. An estimated 11–21 million cases of typhoid fever and 5 million cases of paratyphoid fever occur worldwide each year, causing an estimated 135,000–230,000 deaths. Further, Shigella was the second-leading cause of diarrhoeal mortality in 2016 among all ages, and the leading bacterial cause of diarrhoea, accounting for approximately 212 000 deaths and about 13% of all diarrhoea- associated deaths. ]]> <![CDATA[Zydus Lifesciences to launch protection against new strain of influenza virus ]]> https://biospectrumindia.com/news/95/25740/zydus-lifesciences-to-launch-protection-against-new-strain-of-influenza-virus-.html https://biospectrumindia.com/news/95/25740/zydus-lifesciences-to-launch-protection-against-new-strain-of-influenza-virus-.html Wed, 26 Feb 2025 00:00:00 +0530 Ahmedabad-based Zydus, a leading, discovery-based, global pharmaceutical company, is ready to launch the season’s first India’s Flu protection as per WHO recommended composition of quadrivalent influenza virus vaccines for use in the 2025 southern hemisphere.  The company’s Quadrivalent Inactivated Influenza vaccine VaxiFlu-4 will offer protection against A/Victoria/4897/2022 (H1N1)pdm09-like virus, A/Croatia/10136RV/2023 (H3N2)-like virus, B/Austria/1359417/2021 (B/Victoria lineage)-like virus, B/Phuket/3073/2013 (B/Yamagata lineage)-like virus.  A quadrivalent vaccine, by covering strains of both influenza A and influenza B, provides a broader protection and significantly reduces the risk of vaccine mismatch. The vaccine has been cleared by the Central Drug Laboratory (CDL). VaxiFlu-4 is being marketed by Zydus Vaxxicare-a division of the group focussing on preventives. The Quadrivalent Inactivated Influenza vaccine has been developed at the Vaccine Technology Centre (VTC) in Ahmedabad which has proven capabilities in researching, developing, and manufacturing of safe and efficacious vaccines. Speaking on the development Dr Sharvil Patel, Managing Director, Zydus Lifesciences Limited said, “Preventives are the key to public health in both the developing and the developed world and vaccines have the potential to improve the quality of life. In India, there is a pressing need for access to affordable, high-quality vaccines that can address healthcare challenges. With vaccines like VaxiFlu-4 we are serving the cause of public health through annual immunisation and preventing flu outbreaks.” According to the World Health Organization (WHO), seasonal influenza results in 290,000-650,000 deaths every year.   ]]> <![CDATA[Biological E inks strategic partnership with Bavarian Nordic to expand access of Chikungunya Vaccine]]> https://biospectrumindia.com/news/95/25730/biological-e-inks-strategic-partnership-with-bavarian-nordic-to-expand-access-of-chikungunya-vaccine.html https://biospectrumindia.com/news/95/25730/biological-e-inks-strategic-partnership-with-bavarian-nordic-to-expand-access-of-chikungunya-vaccine.html Tue, 25 Feb 2025 00:00:00 +0530 Hyderabad-based Biological E. Limited (BE) has announced a strategic partnership with Bavarian Nordic A/S (OMX: BAVA) to expand access to Bavarian Nordic’s Chikungunya Vaccine in low- and middle-income countries (LMIC). This partnership comprises a technology transfer of the current drug product manufacturing process for the Chikungunya Vaccine, with the option to transfer the drug substance process at a later stage. To that effect, the companies have reached an agreement to expand their capacity to provide future supplies to endemic low- and middle-income countries. The initial technology transfer would be followed by regulatory approval applications and commencement of commercial manufacturing thereafter. BE's existing facilities in Genome Valley, Hyderabad will be augmented to make the Chikungunya Vaccine. The manufacturing of Chikungunya Vaccine at BE is expected to generate up to 300 new jobs. This agreement has come about as Bavarian Nordic continues to explore opportunities in line with its strategy to provide global access to its Chikungunya Vaccine via partners for markets outside the US and Europe. In February 2025, the US Food and Drug Administration (FDA) approved VIMKUNYA (CHIKV VLP) as the first chikungunya vaccine for persons as young as 12 years. An EU approval is pending decision from the European Commission following a recommendation in January 2025 by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA).   ]]> <![CDATA[Merck opens formulation & technology centre in Navi Mumbai]]> https://biospectrumindia.com/news/95/25731/merck-opens-formulation-technology-centre-in-navi-mumbai.html https://biospectrumindia.com/news/95/25731/merck-opens-formulation-technology-centre-in-navi-mumbai.html Tue, 25 Feb 2025 00:00:00 +0530 Merck Life Science has unveiled its Formulation & Technology Centre in Turbhe, Navi Mumbai. As a key part of Merck’s global R&D network, this next-generation facility will serve as a hub for industry collaboration, equipping pharmaceutical companies with advanced tools to optimise drug formulation and accelerate time-to-market across India, APAC, Middle East, and Africa. The Formulation & Technology Centre intends to function as a technology storefront, offering advanced formulation and processing solutions to address the growing demand for complex drug formulations. More than being just a lab; it is a space where knowledge meets practice. The facility is designed to bridge the gap between research and commercial production, helping pharmaceutical manufacturers navigate patent challenges and enhance their product pipelines.  Customers will have access to hands-on training, technical consulting, and tailored solutions designed to tackle challenges in formulation development, production scaling, and troubleshooting. Dr Jitendra Kumar Managing Director, Biotechnology Industry Research Assistance Council (BIRAC) and Archana Jatkar, Associate Secretary General, Indian Pharmaceutical Alliance attended the launch event virtually of the Formulation & Technology Centre, while key dignitaries, including Achim Fabig, Consul General, German Consulate Mumbai; Stefan Halusa, Director General, Indo-German Chamber of Commerce; Makarand Avachat, Executive Vice President, Pharma Research, Lupin Ltd. joined Merck’s leadership team. Pratima Reddy, Country Speaker for Merck India & MD, Merck Specialties, Dhananjay Singh, Managing Director - Life Science, Head of Science and Lab Solutions, India at Merck Life Science, Aditya Sharma, Head of Process Solutions, India Region Dr. Alessandra Ambruosi, Director & Head of Solid Formulations & Pharm Materials R&D, Merck Life Science and Dr Hemgir Gosavi, Head of Formulation & Technology Center, R&D- Solid formulation, Merck Life Science represented the India leadership team at Merck to celebrate this occasion.  The Centre reinforces the company’s commitment to industry-academia collaboration, sustainability and customer-centric innovation. By expanding its capabilities, Merck aims to empower scientists, researchers, and pharmaceutical manufacturers with technical consulting, tailored solutions, and expert-led training programs that support advanced drug formulation and development. By supporting our customers and partners in their journey, we are contributing to the global advancement of pharmaceutical sciences. ]]> <![CDATA[Biologics Conference 2025 Concludes Successfully, Setting New Benchmarks in Biopharmaceutical Innovation and Collaboration]]> https://biospectrumindia.com/news/95/25676/biologics-conference-2025-concludes-successfully-setting-new-benchmarks-in-biopharmaceutical-innovation-and-collaboration.html https://biospectrumindia.com/news/95/25676/biologics-conference-2025-concludes-successfully-setting-new-benchmarks-in-biopharmaceutical-innovation-and-collaboration.html Fri, 14 Feb 2025 00:00:00 +0530 Goa, India – The Institute of Chemical Technology, Mumbai, in collaboration with the Mumbai Biocluster, successfully hosted the 5th Annual Summit of Biologics Conference and Workshops focused on Biopharmaceutical Product Development on January 30-31, 2025, at the Novotel Dona Sylvia Resort, Goa. This landmark event has evolved into a premier platform bringing together key stakeholders for scientific exchange, business networking, and industry advancement. The conference witnessed an overwhelming response, bringing together over 700 attendees, including 150 distinguished speakers, 12 key sponsors, and 41 exhibitors. With a strong presence of leading biopharma manufacturers and vendors such as Repligen, ThermoFisher Scientific, Cytiva, Merck, Sartorius Stedim, etc. the event further cemented its position as a pivotal gathering for the biopharma ecosystem. A Grand Inauguration & Key Announcements The event commenced with an inaugural ceremony graced by Chief Guest Dr. Rajesh Gokhale, Secretary, Department of Biotechnology, Government of India. He was joined by Prof. A. B. Pandit, Vice Chancellor- ICT Mumbai, Program Chairs Dr. Narendra Chirmule, CEO - SymphonyTech and Dr. Dhananjay Patankar, Dr. Rajiv Desai, Senior Technical Advisor for  Quality and Regulatory - Indian Pharmaceutical Alliance, Mr. GS Krishnan, President - Association of Biotechnology Led Enterprises and Conference Convener Dr. Ratnesh Jain, Managing Director- Mumbai Biocluster. As part of its commitment to fostering innovation and entrepreneurship, the conference introduced Travel Grants and the Young Leader Program to support and encourage emerging talent in biopharma. A significant highlight was the announcement of the second Dr. K. Anji Reddy Memorial Fellowship for Affordable Biopharmaceuticals, awarded to Dr. Cyrus Poonawalla, Chairman of the Serum Institute of India Pvt. Ltd. Dr. Rajesh Gokhale delivered an impactful talk on ‘Building Next-Gen Biologics’, emphasizing the growing role of biomanufacturing in India’s industrialization and the recently launched DBT BioE3 policy. He stated, “We cannot follow the ‘Silicon Valley playbook’ or ‘MassBio recipe.’ For our country, we need to develop technologies with immense creativity and a vision of indigenous innovation, paving a strong path for the future.” Engaging Discussions and Key Highlights The conference featured a fireside chat on investment opportunities in India's biopharma sector, moderated by Dr. Ratnesh Jain, with esteemed panelists Dr. Rajesh S. Gokhale, Dr. Gautham Nadig (Mynvax Pvt Ltd), Dr. Prem Pavoor (Eight Roads), and Dr. Rahul Singhvi (Co-founder, National Resilience). A powerful plenary talk followed, delivered by Dr. Rahul Singhvi, titled “Catalyzing India’s Biomanufacturing Revolution: Lessons from My Entrepreneurial Journey.” Scientific Sessions & Industry Engagement Day 1 focused on key areas such as regulatory policies, mRNA technology, cell therapy, biologics and biosimilars markets, biomanufacturing, and analytical validation. A key highlight was the session on ‘Biopharmaceutical Product Journey: From Concept to Market,’ featuring insights from léadership from companies like Shilpa Biologicals, Biocon Biologics, Bharat Serums & Vaccines, Premas Biotech, Yapan Bio, and Lupin. The conference also featured BioPitch, a platform for biotech startups, and Catalyst Connect Hour, designed to foster networking between attendees and exhibitors. Day 2 commenced with the Change Makers Plenary Address on “Disrupting Traditional Biomanufacturing” by Dr. Himanshu Gadgil, CEO, Enzene, who introduced EnzeneX™ 2.0, an advanced version of its fully-connected continuous manufacturing™ (FCCM™) platform for economical mAb production for the first time in India. This set an enthusiastic tone for further discussions on cutting-edge advancements in gene therapy, AI-ML integration in biopharma, novel biotherapeutics, and veterinary care. Closed-door sessions on the rising CDMO ecosystem brought together industry leaders from companies like Aragen Bioscience Inc., Aurigene Pharmaceutical Services, Yapan Bio, Shilpa Biologicals, Veeda Lifesciences, Kemwell Biopharma, and Merck, alongside investment firms such as Kotak Equity and Eight Roads, as well as prominent organizations like IPA, Pharmatech Associates, ThermoFisher Scientific, Sartorius Stedim, THSTI, U.S.-India Business Council and CSIR-IGIB. A Visionary Closing & Looking Ahead Throughout the two days, over 70 poster presentations showcased innovative research from academia, startups, CROs, and industry participants. The event concluded on a high note with poster presentation winners receiving INR 25,000 cash prizes, along with awards recognizing the most interactive exhibitors and best exhibitors. Reflecting on the success of the event, organizers emphasized their mission to expand the Biologics Conference into an even larger platform for collaboration and knowledge exchange. “The overwhelming response from industry leaders, innovators, and entrepreneurs reinforces our vision to make India a global hub for biopharmaceuticals,” they stated. The success of Biologics Conference 2025 marks a new milestone in advancing India's biopharma ecosystem, promising even greater opportunities in the future. About Biologics The organizers envision establishing India as a global hub for biopharma innovation, by curating interactive forums facilitating impactful discussions among key stakeholders, to strengthen the nation’s bioeconomy and accelerate advancements in biopharmaceutical research.  With each edition, the conference aims to push the boundaries of scientific excellence and industry growth, shaping the future of biopharmaceuticals in India and beyond. Website: https://biologicsworkshop.com/       ]]> <![CDATA[Foxx Life Sciences Strengthens Presence in Telangana with Two New Manufacturing Plants]]> https://biospectrumindia.com/news/95/25677/foxx-life-sciences-strengthens-presence-in-telangana-with-two-new-manufacturing-plants.html https://biospectrumindia.com/news/95/25677/foxx-life-sciences-strengthens-presence-in-telangana-with-two-new-manufacturing-plants.html Fri, 14 Feb 2025 00:00:00 +0530 Foxx Life Sciences is delighted to announce the successful completion of its Open House event, held at the company's facility in Hyderabad, India. The event was well attended by industry leaders, partners, and community members, marking a significant milestone in Foxx Life Sciences ongoing commitment to innovation and excellence in the life sciences sector. Foxx celebrated 5 years of Bioprocess manufacturing in India and the inauguration of 2 new manufacturing plants, including a new state of the art blow and injection molding facility which is spread across 40,000 sq ft. Guests had the chance to interact with the company's experts, explore the latest advancements in manufacturing, and discover Foxx Life Sciences' innovative solutions. "We are thrilled with the turnout and the positive feedback from our Open House event. This event underscores our dedication to fostering innovation and collaboration in India within the life sciences community” stated Thomas Taylor, Founder and CEO of Foxx Life Sciences Eknath Kulkarni, Co-Founder, Part-Owner, and President of Foxx Life Sciences APAC, said “We are excited to continue building strong relationships with our customers, suppliers, and employees with these new major Investments. From R&D, prototyping, machining, welding, injection molding, clean room assembly, and Asia logistics, Foxx is ready to support our global customers”. Rick Schwartz, President of Foxx Life Sciences, also attended the event and added, "The Open House was a fantastic opportunity to showcase our capabilities and share our vision for the future. We are committed to driving growth and excellence in the industry, and events like this help us connect with the community and highlight our contributions." The 2 new plants in Hyderabad further strengthens Foxx Life Sciences' global positioning and enhances its manufacturing redundancies, ensuring robust and reliable operations across multiple locations. Manufacturing redundancy is critical for Vaccine, Biotech, Pharma and Medical end users. With a focus on quality (ISO 13485 since 2010), seven certified ISO Class 7 clean rooms, 5 manufacturing plants, Foxx is the perfect partner for your next Life Science disposable product or Bioprocess single-use custom assembly.   ]]> <![CDATA[Biovet gets CDSCO license for world’s first ever DIVA marker vaccine for lumpy skin disease ]]> https://biospectrumindia.com/news/95/25654/biovet-gets-cdsco-license-for-worlds-first-ever-diva-marker-vaccine-for-lumpy-skin-disease-.html https://biospectrumindia.com/news/95/25654/biovet-gets-cdsco-license-for-worlds-first-ever-diva-marker-vaccine-for-lumpy-skin-disease-.html Mon, 10 Feb 2025 00:00:00 +0530 Bharat Biotech group company Biovet, an innovative animal health vaccine producer based in Mallur, Karnataka, has announced that its Lumpy Skin Disease (LSD) vaccine for dairy cattle and buffaloes, BIOLUMPIVAXIN, the world's safest and first-ever Differentiating Infected from Vaccinated Animals (DIVA) marker vaccine, has received a license from the Central Drug Standards Control Organisation (CDSCO). The soon-to-be-launched BIOLUMPIVAXIN is the world's only marker vaccine for LSD. It offers a high safety and efficacy profile while enabling serological differentiation between naturally infected and vaccinated animals with the DIVA concept in it. The quality, safety, and efficacy of the vaccine have been extensively tested at ICAR-NRCE and at the Indian Veterinary Research Institute (IVRI), ensuring it meets the highest global standards. This novel Indigenous live-attenuated marker vaccine was developed using the LSD virus/Ranchi/2019 vaccine strain from Indian Council of Agriculture Research-National Research Centre on Equines (ICAR-NRCE), Hisar, in collaboration with Bharat Biotech’s Biovet. Over the past two years, approximately 200,000 cattle have died, and millions more have lost their milk production capabilities due to Lumpy Skin Disease (LSD) nationwide. The LSD vaccine BIOLUMPIVAXIN will very soon be commercially available. The Biovet Mallur facility can produce 500 million doses of BIOLUMPIVAXIN® annually. ]]> <![CDATA[GV Research Platform and BeCytes partner to advance biopharma research in India]]> https://biospectrumindia.com/news/95/25621/gv-research-platform-and-becytes-partner-to-advance-biopharma-research-in-india.html https://biospectrumindia.com/news/95/25621/gv-research-platform-and-becytes-partner-to-advance-biopharma-research-in-india.html Mon, 03 Feb 2025 00:00:00 +0530 Hyderabad-based GV Research Platform (GVRP), a leading provider of preclinical research solutions, has announced a strategic partnership with Spanish startup BeCytes Biotechnologies to expand access to high-quality human and animal-derived biological materials for drug discovery and toxicology research in India. This collaboration leverages BeCytes’ specialised expertise in tissue procurement, primary cell isolation, and in vitro models, enabling Indian researchers to utilise cutting-edge tools for more predictive and translational studies. As part of this partnership, GVRP will facilitate the availability of cryopreserved hepatocytes, hepatic and skin cells, subcellular fractions, and customised cell isolation services, critical resources for drug metabolism, safety assessment, and disease modeling. “As India’s biomedical research landscape continues to expand, access to high-quality biological models remains a key challenge,” said Kalyan Korisapati, Co-Founder & Group CEO of GVRP. “By partnering with BeCytes, we are closing this gap and ensuring that researchers in India have seamless access to best-in-class hepatic cell models, including disease models such as NASH and Liver 3D Spheroids functional models, to advance their discoveries.” BeCytes Biotechnologies has a proven track record of supplying primary human and animal-derived cells to researchers worldwide. Their expertise in cell characterisation and in vitro model development ensures consistency and reliability, addressing a critical need in preclinical drug screening and toxicology studies. ]]> <![CDATA[“Govt should facilitate low-interest loans or VC funding specifically for biopharma startups & small enterprises”]]> https://biospectrumindia.com/views/95/25591/govt-should-facilitate-low-interest-loans-or-vc-funding-specifically-for-biopharma-startups-small-enterprises.html https://biospectrumindia.com/views/95/25591/govt-should-facilitate-low-interest-loans-or-vc-funding-specifically-for-biopharma-startups-small-enterprises.html Fri, 31 Jan 2025 00:00:00 +0530 What are the key objectives of your recent collaboration with Merck? How will this partnership foster innovation and strengthen India’s position in the global biotech market? The partnership combines Merck's biomanufacturing systems with GNG's Clone Development and HIND Antibody Library to drive biopharmaceutical innovation and position India as a hub for advanced R&D. The GNG-Merck collaboration creates a unique competitive edge for both companies by integrating local expertise with global biomanufacturing capabilities. Furthermore, Merck's expertise in both Upstream Processing (USP) and Downstream Processing (DSP) will support us in areas of biologics production, optimising cell culture yields, and refining end products to meet international standards.   This partnership is set to innovate and strengthen India’s biotech landscape: Platform Processes for Novel mAbs and Other Molecules: With Merck’s advanced bioprocessing systems installed at GNG, we’re positioned to efficiently develop and produce novel monoclonal antibodies (mAbs) and other therapeutic molecules. These processes ensure consistent, high-quality products that meet the highest global standards. Supporting Clone Development Services from India: With the integration of Merck’s systems into GNG’s Clone Development platform, we’re set to become a go-to provider for scalable clone development services. This will cater to a wide range of biotech firms, both in India and abroad. Infrastructure for Startups: Our collaboration creates a solid infrastructure for biotech startups, providing end-to-end support—from process development to clinical-phase production. This ensures that biotech startups in India can focus on innovation while we handle the complexities of scaling up. Future Scale-Up and Commercial Manufacturing: With Merck’s decades of expertise in drug development and manufacturing, GNG is well-positioned to advance its capabilities in scaling up production and preparing for commercial manufacturing. This strategic collaboration enables GNG to explore and pursue the commercialisation of its proprietary New Biological Entities (NBE) and biosimilar candidates, ensuring a robust pathway from development to market readiness.   What other plans are in store at GNG for driving innovation? We envision GNG as an emerging leader in novel and biosimilar asset development both as its own pipeline as well as contract research in the coming years. In line with this vision, GNG plans to expand its reach and impact across global biopharmaceuticals, diagnostics, and therapeutic antibody discovery and development. Some of our strategic goals include:  Scaling the HIND Antibody Library: We aim to expand the HIND Antibody Library’s scope to encompass a diverse range of therapeutic targets, positioning it as a vital tool for novel drug discovery and collaborative research from India. Strengthening Biosimilar and Biologic Production: Leveraging our collaboration with Merck and seeking strategic partnerships, we look forward to expanding GNG’s biosimilar offerings to meet the demand for affordable, high-quality biologics in domestic and global markets. Currently one being in pre-clinical studies supported by the National Biopharma Mission, BIRAC. Expanding Diagnostic and Custom Antibody Solutions: As precision medicine continues to gain prominence, GNG plans to develop new diagnostic and antibody solutions for emerging diseases and personalised treatments. Our aim is to be steadfast in our mission to drive innovation and contribute to the future of biotechnology by offering cutting-edge solutions that can transform global healthcare.   Would the new BioE3 policy prove to be a gamechanger for the future of biotechnology in India? Building a robust biomanufacturing ecosystem in India is crucial for accelerating innovations in bio-based product development. With the nation’s bioeconomy projected to reach $300 billion by 2030, the startup community plays a pivotal role in driving this transformation, fostering technological advancements, and addressing industry challenges. In this context, the BioE3 Policy— ‘Biotechnology for Economy, Environment, and Employment’—represents a transformative milestone for India’s biotech sector. By fostering innovation-driven R&D and championing sustainable biomanufacturing, this policy not only aligns with global climate goals but also positions India at the forefront of the circular bioeconomy.  Furthermore, the BioE3 policy will play a pivotal role in enhancing and amplifying the life sciences sector by building a skilled workforce and creating new employment opportunities, thereby strengthening the country’s research capabilities and technological expertise. Additionally, by addressing key infrastructure needs, the policy aims to streamline scaling-up processes, making biotechnology advancements more accessible and cost-efficient. Overall, this policy is a step in the right direction for India’s life science industry. As we continue to support the emerging biotechnology startup community, the advent of this policy will boost our motivation to drive the Circular Economy revolution by 2047.   Though biotech innovation is increasing in our country with technological advancements, innovators still face multiple challenges. What are your views on this and expectations from the government? In recent years, India’s biopharma industry has witnessed significant growth, fuelled by technological advancements, research, and increased manufacturing capabilities. Although the industry holds immense growth potential, it is crucial to tackle challenges that may hinder progress.  Securing adequate funding and managing budgets effectively are significant hurdles for Indian biotech startups. The sector is further challenged by complex regulatory landscapes, high production costs, limited access to advanced technologies, and a shortage of specialised talent in critical domains. Adding to these issues is the urgent need for enhancing the laboratory infrastructure to support research and development. GNG has been  grateful to BIRAC for supporting the development of one of our assets through the National Biopharma Mission Grant. Unlocking the industry’s full potential requires strategic policymaking, a stronger focus on research and innovation, and robust public-private partnerships. Recognising these critical challenges and addressing them decisively at both global and local levels is crucial for driving the next wave of advancements.  We believe the government plays a crucial role in unlocking the full potential of the biotech sector. To drive meaningful growth, a proactive approach is needed to strengthen public-private partnerships, advancing research and technologies, skill development, and constant industry/stakeholder initiatives will amplify the potential of the biotech industry.   Additionally, strengthening ties between academia and industry is essential to drive innovation and build valuable partnerships in research and technological advancements. Government policies that prioritise skill development, empower scientists, and promote R&D can help cultivate a culture of continuous innovation within the sector.  When speaking specifically for Biopharma, the government should develop and implement a comprehensive biopharma policy that incentivises research, innovation, and production and streamline regulatory frameworks to reduce bottlenecks in drug approval and manufacturing processes. The government should facilitate low-interest loans or venture capital funding specifically for biopharma startups and small enterprises. Currently, BIRAC is the only body that does it, but we need more and more government bodies to come up with biopharma-focused financial instruments to attract investors.   Dr Manbeena Chawla (manbeena.chawla@mmactiv.com) ]]> <![CDATA[When can India become a global gateway for the medtech industry?]]> https://biospectrumindia.com/features/95/25593/when-can-india-become-a-global-gateway-for-the-medtech-industry.html https://biospectrumindia.com/features/95/25593/when-can-india-become-a-global-gateway-for-the-medtech-industry.html Fri, 31 Jan 2025 00:00:00 +0530 The Indian medtech market, valued at $12 billion in 2023-24, is projected to reach $50 billion by 2030, with India's global market share set to grow from 1.65 per cent to 10-12 per cent over the next 25 years. Further, Indian medtech exports reached $3.8 billion in 2023-24, with the US as the primary market. Although India is still import dependent in the medtech sector, the growing number of startups in this space are moving the tailwinds in a global direction. Over the past few years, medtech startups have emerged as trailblazers, using innovation to bridge gaps, solve pressing challenges, and unlocking new possibilities in healthcare. This growth is particularly crucial in India, where healthcare challenges include vast geographical disparities, increasing disease burdens, and affordability constraints.   For example, artificial intelligence (AI)-driven diagnostic solutions are helping healthcare providers detect diseases at earlier stages, while wearable devices are empowering individuals to monitor their health in real time. As a result, Indian medtech startups are actively integrating digital solutions such as AI, IoT, and cloud computing to democratise healthcare with portable devices, remote monitoring and screening tools. Taking a few examples, BrainSight AI, a Bengaluru-based deep-tech neuroscience startup, is revolutionising the diagnosis and treatment of complex brain disorders through its technology platform, VoxelBox. Likewise, another Bengaluru-based startup 4baseCare is using advanced genomics and digital health technology to offer cutting-edge precision oncology solutions. The developer of the country’s first indigenous surgical robotic technology, Gurugram-based startup SS Innovations, the visionary force behind Made-in-India SSI Mantra Surgical Robotic System, has recently achieved a historic feat in Indian medical science by becoming the first and only company in India to receive Central Drugs Standard Control Organization (CDSCO) approval for Telesurgery and Teleproctoring, signifying a monumental leap in surgical robotics. Medprime Technologies, a Thane-based medical device company focused on developing cutting-edge healthcare solutions in diagnostics, has announced the launch of Micalys, first-of-its-kind innovative AI-integrated digital microscopy platform that is set to revolutionise digital pathology in India.  “As of 2024, the number of medtech startups has surpassed 10,000, with an impressive annual growth rate of over 15-20 per cent. This expansion is a testament to the sector's ability to address critical healthcare challenges through innovative solutions, including AI, IoT, and nanotechnology integration. Government programmes such as Startup India and Make in India have been instrumental in fostering this growth, encouraging entrepreneurs to focus on affordable, high-quality medical devices”, said Dr Vishal Gandhi, Chief Executive Officer, BioRx Venture Advisors. The Health Ministry, in early November last year, announced the launch of a scheme to strengthen the medical device industry. With an outlay of Rs 500 crore, this scheme is a comprehensive one which targets critical areas of the medical device industry, covering manufacturing of key components and accessories, skill development, support for clinical studies, development of common infrastructure and industry promotion. At present, this scheme is providing regulatory support for 6 technology-based startups funded by Pfizer INDovation Programme. These include- Aarca Research (diagnosing Peripheral Artery Disease), Babycue (POC device for childhood diarrhoea), Biolockey Healthworks (at-home test for cervical cancer), Brela Innovations (breast pads for women for early detection of breast cancer), RNT Health Insights (AI-assisted early gastric cancer detection software) and Utopic Tech (POC test for kidney health). "The government has approved these startups for assistance under the research linked incentive scheme, and also approved their products for support for pre-clinical and clinical studies. We hope to see these innovations entering the market in the next 2-3 years", said Dr Arunish Chawla, the then Secretary, Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers, Government of India while announcing the assistance.  Out of these startups, Chandigarh-based startup RNT Health Insights is gaining global attention as it received second US FDA breakthrough device designation for oesophageal cancer detection tool in January this year. The startup has previously received US FDA breakthrough device designation for its early gastric cancer detection tool. Touching global heights Besides RNT Health Insights, there are numerous medtech startups in India that are developing technology integrated products and launching them in the global market. Mumbai-based Qure.ai is transforming radiology with AI-powered medical imaging, providing faster and more accurate diagnoses. Recently it has achieved a major milestone with the 510(k) US FDA clearance for its latest AI-powered chest CT solution – qCT LN Quant. Designed to assist radiologists and pulmonologists, this advanced solution analyses lung nodules on non-contrast chest CT scans and tracks volumetric growth for precise progression monitoring. In addition, the startup has also received breakthrough device designation from the US FDA Center for Devices and Radiological Health (CDRH) for its AI-powered Tuberculosis (TB) solution, qSpot-TB. Citing another example, Pune-based startup DeepTek's US FDA-approved platform, Augmento Enterprise, has been chosen as the national radiology AI platform, contributing to improved productivity and quality of care across public hospitals in Singapore. Then there is SigTuple, a Bengaluru-based medtech startup that develops Artificial Intelligence (AI) powered digital microscopy solutions. The startup’s path-breaking device AI100 with Shonit (Peripheral blood smear application) has received US FDA 510(k) clearance. This is the first integrated hardware and AI medical device, and the first product in AI assisted digital microscopy from India to obtain the coveted clearance and one of the handful of companies in the world to obtain it.  While the innovation level is touching the sky for our medtech entrepreneurs, these global approvals are making it easier for the products to reach different parts of the world. Simply because developing products as per globally accepted standards ensures smooth export and helps overcome technical or qualitative differences across regions and countries. In this context, Gaurav Agarwal, Managing Director, Innvolution Healthcare is of the opinion, “Any startup with an eye on the future must have global regulatory approvals in its design phase. Today over a dozen Indian medtech companies have strong international presence. I believe in the next 20 years India will corner a large chunk of medtech exports as well. With a favourable investment, regulatory and policy environment, there is an unprecedented surge in medtech startups in the country.” Sharing her perspective, Gauri Navalkar Godse, Director and CEO- India, UE LifeSciences said, “Indian medtech startups aren't waiting for global nods before making waves. They're leveraging India's unique strengths i.e. a massive, diverse population of over 1.4 billion, a burgeoning digital landscape with over 900 million internet users expected by 2025, and supportive government initiatives like Startup India and Make in India, to build innovative solutions first for the Indian market. This approach allows them to rapidly iterate, gather crucial real-world data from this vast user base, and scale quickly, all while directly addressing pressing local healthcare needs.” One of the very earlier players in the medtech startup space, UE LifeSciences received US FDA approval many years ago to launch iBreastExam - a handheld, mobile connected and completely wireless device which can detect tumour tissues as small as 3-5 mm while emitting no harmful radiation. For 2025, UE LifeSciences is poised to launch not one, but two groundbreaking solutions. In the first half of the year, the company is unveiling a novel triple cancer screening solution, offering early detection capabilities, and by year's end, the company will empower individuals with an at-home breast cancer screening solution. Currently, Bengaluru-based startup Niramai has partnered with Goa-based company MolBio Diagnostics to accelerate the adoption of Niramai's AI-based non-invasive breast cancer screening solution in developing countries around the world. “Niramai is the first Indian company to get an US FDA clearance for a medical device used for women’s health. We have also received European CE approval for our Thermalytix Solution. While it is a great learning experience to go through the very rigorous US regulatory process, we have also observed that globally approved products get easily accepted in India. This strengthens the trust factor for an Indian innovation, which can otherwise take time to establish its presence in the market”, said Dr Geetha Manjunath, CEO and Founder of Niramai. Dr Geetha further adds, “As India’s healthcare ecosystem embraces digital transformation, startups are pioneering groundbreaking solutions. But there are challenges that persist for medtech startups in India, especially in terms of funding, investments and getting good collaborative opportunities with bigger medtech players.”   Still a lot more to be done Both established entities and burgeoning startups in the Indian medtech sector are introducing innovative products that cater to local demands while aligning with international advancements. Moving forward, a great strategy would be needed for the established players to collaborate with the startups for expediting the path from ideation to market introduction. “There is a need to connect hospitals, medtech companies, and startups, supporting critical stages such as multi-centric trials, regulatory compliance, securing scale-up funding, and facilitating product launches. For instance, KIIT TBI envisions establishing a Technology Development & Deployment Hub for molecular diagnostics, encompassing translational research, product development, validation, regulatory compliance, and skill development. A significant milestone is the creation of the Centre of Innovation in Molecular Diagnostics, a convergence platform for academia, startups, and industries. This centre, supported by Thermo Fisher Scientific, offers industry-aligned training to biotech scholars while driving product innovation in molecular diagnostics”, said Dr Mrutyunjay Suar, Chief Executive Officer, KIIT-Technology Business Incubator (TBI). Reflecting upon the current funding and investment opportunities in store for the medtech startups, Dr Vishal Gandhi adds, “The funding landscape for medtech startups in India has transformed significantly. Between January and November 2024 alone, venture capital investments across sectors reached $16.77 billion, with medtech being a key beneficiary. This represents a 14.1 per cent increase in value and a 21.8 per cent rise in deal count compared to the same period in 2023.” He also mentions that over the past five years, investments in medtech startups have surged, with significant interest in diagnostics, AI-driven healthcare solutions, and telemedicine platforms. Another important factor that is ensuring success of many medtech innovations in India lately is the presence of cross-functional leadership teams, where one founder can focus on the science and technology, while the other can take the commercialisation aspect forward. As the sector matures, the focus will likely expand to include more advanced technologies, global collaborations, and regulatory harmonisation to unlock its full potential. India's journey to becoming a global healthcare hub is well underway, and the medtech startup ecosystem stands at the forefront of this evolution.   Vrushti Kothari (vrushti.kothari@mmactiv.com) ]]> <![CDATA[Hyderabad-based PopVax wins $2 M to accelerate development of influenza vaccine]]> https://biospectrumindia.com/news/95/25545/hyderabad-based-popvax-wins-2-m-to-accelerate-development-of-influenza-vaccine.html https://biospectrumindia.com/news/95/25545/hyderabad-based-popvax-wins-2-m-to-accelerate-development-of-influenza-vaccine.html Tue, 14 Jan 2025 00:00:00 +0530 PopVax, a Hyderabad-based biotechnology startup developing broadly-protective mRNA vaccines using machine learning-enabled computational protein design, has been awarded $2 million by the United States Biomedical Advanced Research and Development Authority (BARDA) as one of the winners of the Concept Stage of BARDA’s Patch Forward Prize for its seasonal influenza vaccine built on a novel mRNA-encoded immunogen display architecture delivered via dissolvable microarray patch. PopVax is developing this vaccine in partnership with Germany’s LTS Lohmann Therapie-Systeme AG (LTS), a leading player in transdermal drug delivery. The Patch Forward Prize is a multi-stage $50 million competition launched by BARDA to accelerate the development of microneedle patch-based RNA vaccines for COVID-19, seasonal influenza, and pandemic influenza. PopVax intends to use the award it has received to accelerate the development of its influenza vaccine programmes, including its broadly-protective influenza vaccine intended to protect against all key seasonal and pandemic strains in a single shot, leveraging both the LTS microarray patch technology and other delivery modalities. PopVax & LTS Lohmann are now working to advance the self-administered patch-delivered seasonal influenza vaccine into preclinical studies this quarter. PopVax’s next-generation COVID-19 vaccine candidate has been selected for a Phase I trial conducted & sponsored by the National Institute of Allergy and Infectious Diseases (NIAID), part of the US National Institutes of Health (NIH), which is expected to begin in Q2 2025. The company has six novel vaccine candidates in its preclinical pipeline, and intends to initiate five clinical trials over the next two years.  ]]> <![CDATA[Primrose Bio collaborates with Serum Institute of India to develop novel multi-antigen vaccine]]> https://biospectrumindia.com/news/95/25538/primrose-bio-collaborates-with-serum-institute-of-india-to-develop-novel-multi-antigen-vaccine.html https://biospectrumindia.com/news/95/25538/primrose-bio-collaborates-with-serum-institute-of-india-to-develop-novel-multi-antigen-vaccine.html Fri, 10 Jan 2025 00:00:00 +0530 US-based Primrose Bio, Inc., a company with proprietary manufacturing technologies for human therapeutics, and Pune-based Serum Institute of India (SII), the world's largest vaccine manufacturer, have announced a collaboration to develop a novel multi-antigen vaccine for infections that affect millions of people globally. Both companies will contribute towards the design of the vaccine with Primrose fully responsible for developing manufacturing strains using its Pfenex Expression Technology and SII responsible for further development and commercialisation. "We are eager to strengthen our long-standing relationship with Primrose to develop a new vaccine with the potential to save millions of lives globally," said Dr Umesh Shaligram, Executive Director of Serum Institute of India. "This ambitious programme faces many technical challenges, which become more difficult when aiming for global affordability. We believe the robustness of the Pfenex Expression Technology will enable us to solve these technical challenges at a global scale." "We are delighted to deepen our long-standing relationship with SIIPL, a global leader in vaccine innovation," said Helge Zieler, PhD, CEO of Primrose Bio. "This commitment demonstrates the versatility and transformative potential of the Pfenex Expression Technology to address critical vaccine antigen manufacturing and global health needs." SII will collaborate for the development of the manufacturing strains and is responsible for future preclinical and clinical development as well as commercialisation. ]]> <![CDATA[2024 Review of the Indian life sciences sector]]> https://biospectrumindia.com/features/95/25501/2024-review-of-the-indian-life-sciences-sector.html https://biospectrumindia.com/features/95/25501/2024-review-of-the-indian-life-sciences-sector.html Mon, 30 Dec 2024 00:00:00 +0530 Digital transformation, generative artificial intelligence (AI), adoption of virtual health/digital tools emerged as some of the major trends that impacted the life sciences industry in 2024. Overall, 2024 proved to be a pivotal year for the life sciences sector across various verticals such as pharma, biopharma, biotech, diagnostics, medtech, healthcare, bioservices- focusing on multiple aspects such as biomanufacturing, Global Capability Centres, investments, collaborations and much more!   As we move approach 2025, BioSpectrum brings to you the Top 20 major developments in India that made global headlines in 2024-   India Ramps Up HPV Vax Efforts “There is a significant gap in the infrastructure required for AI implementation” Why global pharma companies choose India for GCCs Theme for National Science Day sets in as ‘Indigenous Technologies for Viksit Bharat’ Can India Leverage US Biosecure Act to Strengthen CRDMOs? Health Ministry seeks Google's support for greater collaboration in digital tools Will Boosting Biofoundries Transform India's Biomanufacturing Landscape? Government gives nod to BioE3 policy for fostering high performance biomanufacturing Indian pharmaceutical leaders urge partnership with US for affordable medicine India launches first indigenous antibiotic Nafithromycin to combat drug resistance P&G Health announces launch of innovative tool to help reduce diabetes complications Armed Forces Medical Services & IIT-H ink MoU for collaborative research and training Cabinet approves ‘Bio-RIDE’ scheme to support cutting edge research and development in biotechnology 83.5% of adults in India underestimate shingles risk: Global GSK survey Bayer and Sun Pharma sign marketing agreement for second brand of Finerenone in India Cipla brings revolutionary diabetes management solution to India Philippines announces education policy to open doors for Indian medical aspirants Centre of Excellence in Ayurveda for Diabetes and Metabolic Disorders opens at Indian Institute of Science, Bengaluru JITO Angel Network catalyses healthcare transformation with strategic investment in The RenalProject PM Modi announces grant of $7.5 M to cervical cancer testing, screening, and diagnostics in Indo-Pacific region   ]]> <![CDATA[Valneva expands access for its chikungunya vaccine with Serum Institute of India]]> https://biospectrumindia.com/news/95/25476/valneva-expands-access-for-its-chikungunya-vaccine-with-serum-institute-of-india.html https://biospectrumindia.com/news/95/25476/valneva-expands-access-for-its-chikungunya-vaccine-with-serum-institute-of-india.html Fri, 20 Dec 2024 00:00:00 +0530 France-based Valneva SE, a specialty vaccine company, and Pune-based Serum Institute of India (SII), the world’s largest manufacturer of vaccines by number of doses, have announced an exclusive license agreement for Valneva’s single-shot chikungunya vaccine that enables supply of the vaccine in Asia. The collaboration to support broader access to the vaccine in low-and-middle-income countries (LMICs) in the region falls within the framework of the $41.3 million funding agreement Valneva signed with the Coalition for Epidemic Preparedness Innovations (CEPI) in July 2024 with co-funding from the European Union.  The companies will work urgently to bring the vaccine to the Indian market, and certain other Asian countries, subject to local regulatory approvals, as India is currently enduring one of its worst chikungunya outbreaks. Nearly 370,000 cases were confirmed in India between January 2019 and July 2024, a number rapidly increasing due to the current outbreak. Under the agreement, the companies will conduct a technology transfer of the current drug product manufacturing process. Valneva will supply its chikungunya vaccine drug substance to SII, which will complete manufacturing and be responsible for seeking and maintaining regulatory approval of the vaccine in India and other countries in Asia. Future commercialisation will be based on a profit-sharing model along with single-digit million milestone payments towards technology transfer and regulatory approvals to Valneva. SII will also make available a stockpile of 100,000 doses of the drug product to CEPI as an ‘investigational ready reserve’ that could be used in clinical trials in the region. Such research could provide additional data on the performance of the vaccine among local populations.  ]]> <![CDATA[BioPharma’s Transformative & Strategic Outlook 2025]]> https://biospectrumindia.com/features/95/25405/biopharmas-transformative-strategic-outlook-2025.html https://biospectrumindia.com/features/95/25405/biopharmas-transformative-strategic-outlook-2025.html Sun, 01 Dec 2024 00:00:00 +0530 The Government of India has introduced several Production Linked Incentive (PLI) Schemes aimed at enhancing domestic manufacturing and attracting significant investments in the life sciences-related sectors. Additionally, initiatives like ‘Make-in-India’, the National Biopharma Mission (NBM), as well as new provisions from the Anusandhan National Research Foundation (ANRF), to name a few, are set to boost innovation and technological prowess. Key highlights of 2024 included the approval of the BioE3 (Biotechnology for Economy, Environment and Employment) Policy for biomanufacturing, the Bio-RIDE scheme, Vigyan Dhara scheme. The Union Budget 2024 also focussed on ramping up HPV vaccination efforts and announcing new provisions for the biopharma and healthcare sectors through initiatives like the ANRF. The biopharma sector also saw an influx of startups, SMEs, and international companies in 2024, focusing on precision medicine, biosimilars, and biotherapeutics.  Integration of advanced technologies like bioinformatics, data analytics, and artificial intelligence in bioresearch services is poised to accelerate, enhancing research capabilities and driving growth in BioIT/Research Services. A report by WNS, a leading Business Transformation company, states that the transformation of the pharma sector, globally, in 2025 will rely on technologies such as Artificial Intelligence (AI), Machine Learning (ML), Internet of Things (IoT), data-driven platforms and blockchain. Innovation in the future will take place on the back of digital investments in supply chains, clinical trials, and drug development. Personalised patient-centric healthcare will also become the norm. Other key upcoming trends include the global biosimilars market, therapeutics innovation and sustainable bio-industrial practices. Tech integration in the bio IT/research services will also be a major driver in the coming years. Expanding global acceptance of Indian-made biosimilars presents a lucrative opportunity for the biopharma sector to capture a larger market share in developed countries. Continued advancements in biopharmaceuticals, personalised medicine, and precision treatments are expected to propel the therapeutics segment forward. Considering the digital healthcare perspective, Arvind Vaishnav, Head, Philips Innovation Campus and Innovation Partnerships – Growth region, Philips, Bengaluru says, "The emphasis on automation across healthcare is likely to increase as globally, there is a concerted effort towards addressing staff shortages and at the same time relieving staff of repetitive tasks and processes. Needless to say, this will also save healthcare professionals time, allowing them to spend more time with what’s more critical, spending time with patients. We are already witnessing this with generative AI functioning as a virtual assistant, organising clinical notes and simplifying ways patient information is communicated across teams. It is also now apparent that AI will be adopted beyond automation. It is proven that AI can help simplify complex diagnostics, enabling less experienced professionals to provide high-quality care with confidence. Imagine, AI embedded in ultrasound systems. It allows physicians to detect, diagnose and monitor cardiac conditions more confidently and efficiently. From a technology perspective, it is also interesting to see how introduction of new technologies in interventional care, minimally invasive procedures are becoming more advanced and hence more common. Having said that, this implies the need for Physicians to collect and analyze data from a wide range of sources, such as live X-ray images, 3D ultrasound, Intravascular Ultrasound (IVUS), to name a few all the while closely monitoring the patient. Hence, integration of systems, software and devices will become increasingly important. This integration allows interventional physicians to treat patients with greater control and confidence during every stage of minimally invasive cardiac procedures. While we focus on technology trends in healthcare, it would not be complete without the mention of what is likely to gain traction in 2025: transition towards managing health outside of the hospital. Advances in technology solutions is expected to support remote detection of patient health risks based on vital signs and other data. According to our 2024 Future Health Index report, remote patient monitoring will be the biggest area of planned AI implementation over the next three years, with 41% of healthcare leaders intending to invest in it. This will not only help prevent complications and hospitalisations with timely interventions, but also improve quality of life for patients.’’   Increased Focus on Biomanufacturing  The government introduced the BioE3 policy, a strategic framework designed to propel India into the next era of industrialisation through high-performance biomanufacturing. The BioE3 Policy, approved on August 24, 2024, chalks a strategic roadmap to making India a global biomanufacturing hub by promoting high-performance biomanufacturing through innovation for the development of bio-based products and building an infrastructure that enables scale-up and commercialisation. The six thematic areas of focus highlighted in the BioE3 Policy include bio-based chemicals and enzymes, functional foods and smart proteins, climate-resistant agriculture, carbon capture and utilisation, futuristic marine and space research, and precision biotherapeutics. The policy draws attention to biologics/biotherapies like cell and gene therapy, mRNA therapeutics, monoclonal antibodies, immunotherapy, as well as next-generation vaccines.  In line with these, with a growing portfolio of biosimilars, India has the potential to become a global leader in biotherapeutics. This trend includes precision therapies targeting specific disease markers, such as cancer and autoimmune diseases, highlighting India's ambition to meet rising global demand.  Catalyst to the reaction setup, India’s interest in biofoundries is growing, with biofoundries being positioned as a critical infrastructure for the high-throughput design and testing of genetically engineered organisms. To integrate digital automation and robotic systems to scale up the production of cell lines, proteins, and other biologics, this focus aligns with the government's biomanufacturing push, signalling a shift toward advanced, automated production capabilities.  Biofoundries hold the potential to emerge as the backbone of biomanufacturing and synthetic biology, offering integrated infrastructure to streamline the design, construction, and testing of genetically engineered organisms. Biofoundry is a place where biomanufacturing meets automation. The highly modular structure of a biofoundry helps accelerate the design-build-test-learn (DBTL) workflow to deliver products fast and in a streamlined fashion. Advanced platforms to enable rapid, high-throughput experimentation, and automating processes that were once labour-intensive and time-consuming is a central theme. Innovation-driven biomanufacturing - to develop new biologics, vaccines, gene therapies, and diagnostics - is underway across the globe. Biofoundries are instrumental in revolutionising biotechnology for healthcare, agriculture, and environmental sustainability - from personalised therapies and advanced biologics in healthcare to synthetic fertilisers and sustainable bio-based materials in agriculture. India, too, has come up with multiple initiatives to support and set up biofoundries, such as the BioE3 Policy, the Bio-RIDE scheme, and the Vigyan Dhara scheme. The BioE3 Policy lays out plans for accelerating the transition to biomanufacturing by promoting integrated use of Artificial Intelligence (AI), digitalisation with ‘omics’, and upstream biotechnology innovations through bio-AI hubs, biofoundries, and biomanufacturing hubs across the country. With the new BioE3 Policy in place, coming years will provide insight into how biofoundries will play a role in boosting innovation, scale-up and commercialisation of bio-based products. In addition, with a Global Biofoundry Alliance now established to coordinate biofoundry activities and innovations worldwide, India is positioning itself in this rapidly evolving field, through the establishment of biofoundries infrastructure to advance India’s biomanufacturing goals.  A May 2024 report by Frost & Sullivan, exploring the topic of Contract Development and Manufacturing Organisations (CDMOs) empowering the large-scale production of biologics, reveals that CDMOs are advancing the biopharmaceutical industry with superior biomanufacturing capabilities. The biopharmaceutical industry is expanding rapidly. More biologics programmes have entered late clinical and commercialisation stages globally. The number of FDA-approved biologics and cell/gene therapies rose from 11 in 2019 to 24 in 2023. In 2023, more than half of the top 10 best-selling drugs were biologics with five monoclonal antibodies, one polypeptide, one vaccine, and three chemical drugs. This demand calls for scaling up commercial production, and efficiency has become essential to enterprises. Due to the trend of specialisation and especially contract development, the global biopharmaceutical landscape is increasingly shaped by CDMOs undertaking commissioned productions and offering unique solutions with higher added value. Production expansion for a more complex category of biologics is facilitated by the flourishing industry, accelerated drug approvals, and booming global demand for biosimilars. This is an opportunity for biologics CDMOs who can address the high costs of self-built production lines, limited experiences in R&D and production, and other challenges faced by traditional pharmaceutical companies. The global market size of biologics CDMOs has grown significantly from $13.3 billion in 2018 to $29.3 billion in 2022 and is projected to reach $58.1 billion by 2026 and $100.4 billion by 2030. The report also states that manufacturing capacities are shifting towards the Asia-Pacific region. CDMO services are rising in the Asia-Pacific region because biopharmaceutical companies are seeking cost-effective and efficient R&D and manufacturing services to address the increasing demand. Global biopharmaceutical production capacity and consequently CDMOs are shifting towards this region as a result of continued efforts in improving infrastructure, industry chain supply, project management, quality management systems, and intellectual property protection. Establishing international production facilities and R&D centres are essential strategies for CDMOs in the Asia-Pacific region to enter the global market. With India aiming to implement large-scale biomanufacturing initiatives, boosting talent and investments in biotech and biopharma, in addition to global developments like the US Biosecure Act, this trend in the biopharma industry holds significance for APAC’s leading biopharma hub.    Cell and gene therapy   In October 2023, the Central Drugs Standard Control Organisation (CDSCO) approved NexCAR19, India’s domestically developed CAR-T cell therapy - the world’s most affordable CAR-T cell therapy; and in 2024, the therapy has been made available to patients at several cancer centres/hospitals. In a recent success story from Bengaluru-based Eyestem Research, the company announced a positive outcome of the Drug Safety Monitoring Board (DSMB) review for the first cohort of its Phase one trial to treat Geographic Atrophy secondary to Dry Age-related Macular Degeneration. Eyestem’s lead product, Eyecyte-RPE, is a patented suspension of retinal pigment epithelium cells aimed at combating geographic atrophy arising from Dry AMD. This pioneering treatment marks a major milestone in the global fight against vision loss, as it has the potential to replace damaged retinal cells.  With the BioE3 policy focussing on cell and gene therapy as part of the precision biotherapeutics space, this as-yet niche area is set to get a boost in the coming year. For example, larger, established companies like Miltenyi Biotech, and Intas Pharma are also entering into the cell and gene therapy space in India. Miltenyi Biotec, a global leader in biomedical solutions, has announced the signing of a Letter of Intent with the Translational Health Science and Technology Institute (THSTI), an autonomous institute of the Department of Biotechnology, Ministry of Science and Technology. With this partnership, both organisations aim to address the growing need for innovative treatments in the fight against cancer through cell and gene therapies. The purpose of this collaboration is to focus on leveraging the strengths of both organisations to enhance research and development in cell and gene therapy focusing on cancer and sickle cell disease. This collaboration would help in capacity building, technology transfer, training programmes, and joint research initiatives which would then be translated into medical therapies.    Vaccine Innovation   India’s vaccine manufacturing is poised for further growth, supported by the Government of India’s Production Linked Incentive (PLI) scheme, encouraging the use of new technologies to expand capacity. Additionally, international collaborations with countries such as the US, Japan, and Australia are aiding India in enhancing its capabilities. While challenges remain in making advanced, next-generation vaccines accessible and affordable for India’s large population, continued investment, technological progress, and strategic policies position India as a key player in global vaccine innovation and production. India’s current focus on interdisciplinary research, government support, and collaborations seems to be laying the groundwork for sustainable vaccine innovation. Novel vaccine platforms are emerging worldwide. COVID-19 has resulted in an innovation surge in vaccine development globally. The advent of the COVID-19 pandemic brought the mRNA technology to the forefront. Beyond Pfizer and Moderna, who were pioneering leaders in bringing mRNA vaccine platform to the community, the indigenously developed ‘GEMCOVAC-19’ vaccine is the only third mRNA vaccine to be approved for COVID-19 in the world and is the very first mRNA vaccine developed in India in June 2023. Developed by Pune-based Gennova Biopharmaceuticals in collaboration with the Department of Biotechnology (DBT), this Omicron-specific mRNA (booster) vaccine ‘GEMCOVAC-OM’ is thermostable, which does not require ultra-cold chain infrastructure used for other approved mRNA-based vaccines, making it easy for deployment pan India. It is delivered intradermally using a needle-free injection device system.  In May 2024, biopharma companies Gennova and Emcure announced the resumption of their mRNA collaboration with US-based HDT. The long-term agreement will focus on developing mRNA vaccines against a broad range of infectious diseases, in India and several other countries. As part of their agreement, HDT has granted a license to Gennova to use HDT’s patented mRNA vaccine technology in multiple fields. In September 2024, Hyderabad-based Bharat Biotech announced a collaboration with US-based Alopexx, Inc., for the co-development and commercialisation of Alopexx’s proprietary broad-spectrum anti-microbial vaccine, AV0328, in India and other low-income and lower-middle-income countries. As part of the collaboration, the companies will co-develop and commercialise AV0328, a synthetic vaccine targeting poly N-acetyl glucosamine (PNAG), in India and other licensed territories. A phase I, first-in-human trial has been completed, demonstrating that AV0328 is well-tolerated with no serious adverse events observed. The vaccine-induced antibodies are capable of killing a wide range of PNAG-expressing pathogens, reaffirming its potential as a broad-spectrum antimicrobial solution. Looking ahead, India’s new government policies and the global scenario could start shaping the trend in the direction of vaccine innovation in the coming year - looking to expand its research and development of next-gen vaccines, bridging gaps with faster, more economical platforms to address both local and global health challenges.   Growth in Biosimilars During September and October 2023, The Organisation of Pharmaceutical Producers of India (OPPI) and EY conducted primary research with the CXOs of the leading Indian and global multinational pharma companies, contract research development and manufacturing outsourcing organisations (CRDMOs), startups, patient advocacy groups, and other organisations to understand their perspective about the potential ambition for the pharma and healthcare sectors in the country for India@100. The report sheds light on some elements of the country’s pharma/biopharma sector that we can expect to see growing in the coming year(s). The report conveys that the research pointed out three goals for the industry: Become the innovation powerhouse of the world, become an integral part of the global pharma supply chain, and achieve sustainable and equitable healthcare access for all. The report also states that as the competition and pricing challenges in the generics market continue to grow, some Indian companies have started venturing into the less crowded complex generics space. Biosimilars are increasingly becoming a focal point for India. Continued endeavours are underway in the realms of new chemical entities (NCEs) and new biological entities (NBEs). India’s position as an emerging leader in the global biosimilar market, emphasises the country’s capabilities, growth trajectory, and strategies to address accessibility and affordability in healthcare. Valued at $349 million in 2022, the Indian biosimilars market is projected to grow to $2.1 billion by 2030. It represents nearly 20 per cent of the domestic pharmaceutical market, with sales expected to double from $6 billion in 2022 to $12 billion by 2025. India approved its first biosimilar, a hepatitis B vaccine 2000, ahead of the US and Europe. Over 100 biosimilars have since been approved, covering vaccines, insulin, and monoclonal antibodies. Indian biosimilars are exported to highly regulated markets like North America, Europe, and Japan, fueled by the expiration of over 55 biologic patents globally between 2022 and 2032. With advancements in technology and support from government initiatives, Indian companies are set to drive significant global impact, delivering affordable and high-quality biosimilar therapies to meet growing healthcare demands. To put this in perspective, this is a critical factor for an emerging and growing market like India as biologics worth over $200 billion are set to go off-patent by 2030, an opportunity in the waiting for Indian companies to grab. Leading Indian firms in this space are expected to take advantage of the off-patent regime and further penetrate the global biosimilar markets by providing low-cost high-quality medicines. The pipeline for biosimilars in India is robust, fuelled by the government's initiative to offer subsidies to the local biosimilars manufacturers. This growth is also driven by the Central Drugs Standard Control Organisation (CDSCO)’s aligning guidelines closely with global regulators, including the United States Food and Drug Administration (USFDA) and the Medicines and Healthcare Products Regulatory Agency (MHRA). Bengaluru-based Biocon Biologics has been a leader in this category. Over the last year, Biocon has further expanded its biosimilar portfolio with new product offerings and has deepened partnerships in the US and Europe to strengthen distribution channels. The company has also invested in its R&D pipeline for oncology and immunology treatments, reflecting a broader industry trend towards biosimilars.   A Forward-looking Strategy  Significant milestones in India's biopharma industry over the past year include advancements in biosimilars, novel biologics, and precision medicine, along with scaling manufacturing capabilities to meet international standards. Industry leaders have embraced cutting-edge technologies such as AI-driven drug development, continuous manufacturing, and biofoundry automation, driving innovation and efficiency. The growing pipeline of biosimilars and biologics, coupled with increasing regulatory approvals in global markets, reflects the sector's commitment to quality and compliance. This progress aligns seamlessly with emerging trends anticipated for the coming year.  As numerous Indian companies embark on their journeys into the realms of ADCs, DNA and RNA-based vaccines and therapies, and cell and gene therapy, India is poised to undergo a transformative shift, progressing toward its Discovery 1.0 phase. The global focus on personalised healthcare, rising demand for biologics, and increasing adoption of advanced biomanufacturing technologies will create opportunities for Indian biopharma to expand further. The industry's emphasis on affordability, accessibility, and innovation positions it to address the global demand for cost-effective therapies, particularly in regions facing healthcare inequities. As India continues to leverage its strengths—such as a skilled workforce, robust infrastructure, and government support—2025 promises to be a year of greater collaboration, research breakthroughs, and market expansion. With a forward-looking strategy, the Indian biopharma sector is not only poised to sustain its growth trajectory but also to redefine its role as a global hub for biopharma innovation and excellence.   Shivani Thakar shivani.thakar@biospectrumindia.com  ]]> <![CDATA[Abbott launches 14 valent Pneumococcal Conjugate Vaccine (PCV-14) in India]]> https://biospectrumindia.com/news/95/25401/abbott-launches-14-valent-pneumococcal-conjugate-vaccine-pcv-14-in-india.html https://biospectrumindia.com/news/95/25401/abbott-launches-14-valent-pneumococcal-conjugate-vaccine-pcv-14-in-india.html Wed, 27 Nov 2024 00:00:00 +0530 Abbott, the global healthcare leader, has announced the launch of its Pneumococcal Conjugate Vaccine, PneumoShield 14, for children over 6 weeks of age. Abbott’s PCV-14 valent (Pneumococcal Conjugate Vaccine), offers broad protection, covering the highest number of serotypes, or strains, as compared to existing PCV-10 and PCV-13 vaccines. A strain refers to a genetic or structural variant or subtype of a microorganism. The PCV-14 terminology in Abbott’s PneumoShield 14 vaccine refers to the fact that this vaccine offers protection against 14 different strains of pneumococcal bacteria. A conjugate vaccine is a distinct type of vaccine that combines a part of the bacteria with a protein to make it work better. This helps the immune system recognise and fight off the bacteria more effectively, making it stronger against certain infections, which can result in severe diseases, especially among children. Children under five years of age, especially those aged two years or under, face a high risk of pneumococcal disease, which is caused by a bacterial infection. Pneumococcal infections can result in a range of conditions, including pneumonia, meningitis (inflammation of the tissues surrounding the brain and spinal cord), or blood infections, collectively known as Invasive Pneumococcal Disease (IPD). Vaccination can protect against some of these infections and can prevent complications in children. IPD is associated with high mortality in children under five years of age, resulting in 14% of deaths in India. The PCV-14 vaccine protects against five more strains than the PCV 10, and two more strains than the PCV 13 vaccines that are currently used in India, in private clinics and hospitals. The recommended immunisation schedule for PneumoShield 14, which is administered via intramuscular injections, is at 6, 10, and  14 weeks. ]]> <![CDATA[CPHI & PMEC India 2024 Poised for Record-Breaking Attendance with 50,000+ Pharma Executives]]> https://biospectrumindia.com/news/95/25319/cphi-pmec-india-2024-poised-for-record-breaking-attendance-with-50000-pharma-executives.html https://biospectrumindia.com/news/95/25319/cphi-pmec-india-2024-poised-for-record-breaking-attendance-with-50000-pharma-executives.html Mon, 04 Nov 2024 00:00:00 +0530 CPHI & PMEC India (26th- 28th November, 2024) – the largest pharma event in India  –  returns next month, with a record attendance of over 50,000 pharma executives expected from more than 150 countries.   The news is a further boon for India – widely identified by analysts as a key beneficiary of recent macro tensions – as a strong CPHI & PMEC India is a leading indicator of growth for the country in the year ahead. In fact, emphasizing this shift in prospects, this year’s event will be the largest ever, with more than 2,000 exhibitors (hundreds more than previous editions).   Supporting India’s growth trajectory, the newly released CPHI Annual Survey 2024 once again ranks India as the top ‘growth nation’ for the upcoming 12 months, solidifying its lead over other major pharma hubs. This growth is driven by positive developments in the CDMO sector and an anticipated surge in CRO services accelerated by initiatives like BIOSECURE. Mirroring this trend, India also topped the CDMO table for predicted ‘growth over the next three years’ and finished only narrowly behind  the USA  for ‘overall competitiveness.   Olga Ponomareva-Stepnaya, Brand Manager of CPHI & PMEC India, commented: “It has been an incredibly positive year for the Indian pharma industry, and we are witnessing this firsthand with a record attendance, including over 5,000 international participants. On the show floor we are seeing a wide breadth of local ingredient suppliers, alongside many new advanced equipment providers as the country and regional partners seek to wider their supplier base and modernize equipment during this period of growth.”   CPHI India has responded to rising demand by launching several new initiatives, including the Connections Programme, offering a dedicated service for attendees seeking high-value deals. The programme is designed to help connect international key buyers with the right exhibitors and make high-value deals following feedback was challenging to meet the right supplier at such a large event.’   Reflecting wider industry trends, the event has also seen increased interest in start-up companies and will host a dedicated space for emerging enterprises disrupting the pharmaceutical landscape in India. The campaign forms part of Informa’s wider commitment to innovation with similar start-up programmes launched at other global CPHI events.   To help attendees capitalize on growth opportunities, the event’s conference agenda will feature xx sessions covering spanning two separate streams: the day one ‘Pharma Manufacturing Conclave’ and the day two ‘Pharma Sustainability Conclave’. Topics include key issues from biosimilar supply chains, manufacturing infrastructure for next-gen therapeutics, to addressing critical sustainability challenges in Indian pharma and new approach to green chemistry and pharm regulations.   The India Pharma Awards 2024, now in its 11th edition, will recognize excellence across 13 categories, celebrating the contributions of industry leaders, innovators, and visionaries from across the Indian pharmaceutical sector. The awards ceremony will take place on the evening of 28th November 2024 at the Expo Centre.   ]]> <![CDATA[Emcure Pharma strengthens derma portfolio with launch of Emcutix Biopharmaceuticals]]> https://biospectrumindia.com/news/95/25303/emcure-pharma-strengthens-derma-portfolio-with-launch-of-emcutix-biopharmaceuticals.html https://biospectrumindia.com/news/95/25303/emcure-pharma-strengthens-derma-portfolio-with-launch-of-emcutix-biopharmaceuticals.html Wed, 30 Oct 2024 00:00:00 +0530 Mumbai-based Emcure Pharmaceuticals is set to cater to a growing dermatology segment in India with formation of a wholly-owned subsidiary, Emcutix Biopharmaceuticals. As a part of this strategic initiative, Emcure's existing dermatology business will also operate under Emcutix. With a renewed focus and a dedicated team, the newly setup entity plans to significantly expand Emcure’s offerings. The focus will be on building a differentiated product portfolio including first-time launches designed to fulfil the unmet needs of the Indian dermatology market. The market is seeing strong growth primarily driven by a growing population. As per IQVIA, the Indian dermatology market stands at $1.84 billion (MAT sales July 2024). Emcutix will be spearheaded by G. Sathya Narayanan, who brings with him over three decades of extensive experience in the dermatology sector, with his last stint as the Managing Director of Galderma for South Asia (including India). His notable career includes building some of the most iconic brands in prescription, consumer, and aesthetic dermatology.  ]]> <![CDATA[WHO prequalifies Zydus’s Typhoid Vi Conjugate Vaccine, ZyVac ® TCV]]> https://biospectrumindia.com/news/95/25290/who-prequalifies-zyduss-typhoid-vi-conjugate-vaccine-zyvac-tcv.html https://biospectrumindia.com/news/95/25290/who-prequalifies-zyduss-typhoid-vi-conjugate-vaccine-zyvac-tcv.html Fri, 25 Oct 2024 00:00:00 +0530 Zydus Lifesciences has received in principle acceptability from World Health Organisation (WHO) for ZyVac® TCV. ZyVac® TCV is now eligible for purchase by United Nations (UN) agencies. ZyVac® TCV is indigenously developed and manufactured at the Zydus Biotech Park, Ahmedabad. ZyVac® TCV is indicated for active immunisation against Salmonella typhi infection in the age group of 6 months to 65 years. This prequalification for ZyVac® TCV makes it eligible to be part of UN agencies procurement programme. Annually over 150 million doses of the typhoid conjugate vaccine is procured by UN agencies to prevent this infectious disease in geographies where it is most prevalent, such as India, Africa and Southeast Asia. Typhoid fever is systemic febrile illness caused by ingestion of the bacterium Salmonella enterica serovar typhi (S. typhi) through contaminated water and food. In South Asian region, India alone contributes for 75% of incidence and mortality due to typhoid fever. As per GAVI (2022) it is estimated that Typhoid accounts for an estimated 11 to 21 million cases of febrile illness and 117,000 to 161,000 deaths are attributed to the disease each year. Data reviewed by the WHO Strategic Advisory Group of Experts on Immunisation (SAGE) indicates that a major burden of severe disease occurs in younger age groups where 27% of all typhoid disease occurs in children under five years of age. ]]> <![CDATA[CDRI, Lucknow and Zydus to develop drug for chronic kidney disease induced osteoporosis]]> https://biospectrumindia.com/news/95/25218/cdri-lucknow-and-zydus-to-develop-drug-for-chronic-kidney-disease-induced-osteoporosis.html https://biospectrumindia.com/news/95/25218/cdri-lucknow-and-zydus-to-develop-drug-for-chronic-kidney-disease-induced-osteoporosis.html Mon, 30 Sep 2024 00:00:00 +0530 Based on research conducted at Central Drug Research Institute (CDRI), Lucknow and data from antibody-based therapies (biologics), a protein Sclerostin, has emerged as a promising drug target for treating chronic kidney disease (CKD) induced osteoporosis as well as postmenopausal osteoporosis. Studies suggest that the protein Sclerostin plays a key role in the dysregulation of bone metabolism. In patients with advanced stages of CKD and osteoporosis, Sclerostin levels are observed to be high. To develop oral medication through the discovery of small molecule inhibitors of Sclerostin, a collaborative research agreement has been signed by Zydus Lifesciences, Ahmedabad and CDRI. Under this agreement, CDRI and Zydus will jointly undertake preclinical research. Any drug candidate emerging from the efforts will be developed by Zydus for India and other markets. CKD affects over 10% of the global population, posing significant health challenges. One of the major complications of CKD is disruption of mineral metabolism, increasing the risk of osteoporosis and fractures. Those above the age of 65, particularly women, are at higher risk. Unfortunately, most of the conventional anti-osteoporosis medications are contraindicated in patients with CKD, due to the risk of worsening renal function. Therefore, there is an urgent need to develop safe and effective drugs for osteoporosis that will reduce fracture risk without a deterioration of renal function.  ]]> <![CDATA[Two cutting-edge life sciences facilities open at Genome Valley creating 10000+ jobs]]> https://biospectrumindia.com/news/95/25149/two-cutting-edge-life-sciences-facilities-open-at-genome-valley-creating-10000-jobs.html https://biospectrumindia.com/news/95/25149/two-cutting-edge-life-sciences-facilities-open-at-genome-valley-creating-10000-jobs.html Mon, 16 Sep 2024 00:00:00 +0530 Duddila Sridhar Babu, Minister of Information Technology, Electronics, Communications, Industries & Legislative Affair, inaugurated two cutting-edge life sciences facilities at Genome Valley and presided over the groundbreaking of Biopolis, an ambitious new research campus. The Minister inaugurated a new Research and Development facility by Laurus Labs, one of India’s leading pharmaceutical companies. Known for its leadership in developing Active Pharmaceutical Ingredients (APIs) and formulations, Laurus Labs continues to expand its innovation capabilities. Recently, Laurus Labs had announced a cutting-edge manufacturing facility in partnership with KrKa, a prominent European company. The upcoming manufacturing facility and the new R&D facility together represents an investment of Rs 2,250 crore over the next 4 years creating 2800 jobs, marking a significant milestone in its mission to deliver cutting-edge healthcare solutions, both in India and on the global stage. Additionally, D Sridhar Babu inaugurated 3GV, a multi-tenanted life sciences facility spanning 150,000 square feet. Notably, 3GV is the world’s first EDGE Advanced certified life sciences facility, a global standard for sustainable infrastructure in the sector. With an infrastructure investment of Rs 105 crore, thereby creating over 1000 new jobs, the facility provides state-of-the-art laboratory spaces for companies of all sizes, from dynamic startups to established global players. The Minister also broke ground on Biopolis, an 8.5-acre research campus that will offer 1,000,000 square feet of advanced lab spaces, designed to support collaboration among research organisations, pharmaceutical giants, and startups. This ambitious project, with an infrastructure investment of Rs 700 crore, is expected to generate 6,500 jobs, further cementing Telangana’s status as Asia’s foremost life sciences hub. In addition to the facility visits, the Minister held high-level discussions with 30-40 key industry leaders from companies like Bharat Biotech, Syngene, Biological E, JAMP Pharma etc., focusing on the future development of Genome Valley. ]]> <![CDATA[Biopharma Industry in India: Conclusion and Way Forward]]> https://biospectrumindia.com/features/95/25192/biopharma-industry-in-india-conclusion-and-way-forward.html https://biospectrumindia.com/features/95/25192/biopharma-industry-in-india-conclusion-and-way-forward.html Mon, 16 Sep 2024 00:00:00 +0530 The biopharma industry in India has been witnessing significant growth in recent years. With advancements in genetics, molecular biology, and Immunology, the industry is at a juncture of significantly impacting healthcare. Evolving around innovative frontiers such as biologics, biosimilars, vaccines, and emerging technologies like cell and gene therapy, the biopharma sector is positioned to become a global leader. The Indian biopharma industry has a solid foundation owing to its extensive expertise in generic drugs. India has been a major player in the production and export of generic pharmaceuticals for many years. Its distinctive strengths reside in a vast pool of skilled scientific human resources, a robust network of research laboratories, a flourishing pharmaceutical industry, and a system that encourages innovation through various incentives. These underpinning strengths provide an encouraging basis for the advance of the biopharma industry. A new wave of biologics is increasing India's potential in the biotech industry. Biologics, highly sophisticated large molecule drugs derived from living organisms, are revolutionizing the treatment approach for many severe diseases. These drugs, which include monoclonal antibodies and recombinant proteins, are known for their high efficacy and specificity in targeting diseases. With a growing demand for biologics globally, India has positioned itself as a preferred destination to produce these complex molecules due to its cost-effective manufacturing capabilities. Biosimilars represent the next frontier in the growth of the Indian biopharma industry. India has become a prominent player in the biosimilars market due to its expertise in developing and manufacturing these products at competitive prices. The country's ability to produce high-quality biosimilars has enabled it to tap into the growing demand in both domestic and international markets. As the patents for original biologic medicines are expiring, the biosimilars market is expected to expand immensely. Vaccines are another critical aspect that contribute robustly to the growth of India's biopharma industry. India, often referred to as the "pharmacy of the world," is one of the largest global vaccine suppliers. It is a global leader in vaccine manufacturing, producing vaccines for diseases such as pneumonia, meningitis, rotavirus, yellow fever, and polio. Indian pharmaceutical companies play a vital role in ensuring affordable access to vaccines, particularly for low- and middle-income countries. The COVID-19 pandemic has underscored the critical functionality of the Indian vaccine industry. Indian companies like Serum Institute of India and Bharat Biotech have played integral roles in addressing the global vaccine demand, underscoring the industry's crucial role. Furthermore, the Indian biopharma industry is also exploring emerging technologies like cell and gene therapy. These therapies have shown tremendous promise in treating various diseases, including cancer, genetic disorders, and autoimmune conditions. Currently in their nascent stages, these technologies are set to evolve rapidly, given their vast potential to revolutionize therapeutics. The country's focus on research and development, coupled with its cost-effective manufacturing capabilities, positions it well to capitalize on the growing demand for cell and gene therapies. In addition, the advent of artificial intelligence (AI) and machine learning technologies are catalysing research and development processes in the biopharma industry by optimising drug design, shortening clinical trials, and improving diagnosis. These advanced technologies hold the promise of transforming the industry by allowing personalized medicine and improving disease management. While it is evident that the potential for growth in India's biopharma industry is enormous, it is crucial to navigate the challenges that could slow this progress. These include regulatory challenges, high manufacturing costs, limited access to advanced technology, and talent shortage in specific areas. Nevertheless, with the government's support in creating favourable policies and making strategic investments, these challenges can be systematically addressed. In conclusion, with the increasing confluence of biologics, biosimilars, vaccines, and emerging technologies like cell and gene therapy, the Indian biopharma industry is poised for a leap. The country's strength in science, research, and manufacturing, coupled with the ongoing evolution of advanced technologies, highlights India's potential to emerge as a global biopharma hub. However, integrating strategic policymaking, fostering research and innovation, and fortifying public-private partnerships are crucial to realise this potential completely and sustainably.         About Gubbi Labs Gubbi Labs is a private research collective that works on various domains ranging from sustainable ecosystems to liveable settlements.  As part of its science communication initiative, it runs Research Matters, a multilingual science news portal.   About Cactus Communications Cactus Communications is a science communication and technology company, accelerating scientific advancement by making science globally accessible.   ]]> <![CDATA[Bharat Biotech announces collaboration with Alopexx for development of broad-spectrum anti-microbial vaccine]]> https://biospectrumindia.com/news/95/25133/bharat-biotech-announces-collaboration-with-alopexx-for-development-of-broad-spectrum-anti-microbial-vaccine.html https://biospectrumindia.com/news/95/25133/bharat-biotech-announces-collaboration-with-alopexx-for-development-of-broad-spectrum-anti-microbial-vaccine.html Wed, 11 Sep 2024 00:00:00 +0530 Hyderabad-based Bharat Biotech has announced a collaboration with US-based Alopexx, Inc., for the co-development and commercialisation of Alopexx’s proprietary broad-spectrum anti-microbial vaccine, AV0328, in India and other low income and lower middle-income countries. As part of the collaboration, the companies will co-develop and commercialise AV0328, a synthetic vaccine targeting poly N-acetyl glucosamine (PNAG), in India and other licensed territories. Alopexx would be entitled to a one-time upfront payment and milestone payments, as well as royalties on future sales of AV0328 in the licensed territories. Dr Krishna Ella, Executive Chairman of Bharat Biotech, commented, “Our goal is to develop solutions to reduce anti-microbial resistance through vaccination. This collaboration aligns with our mission to provide safe, affordable, and high-quality vaccines to combat infectious diseases globally.” AV0328 is a synthetic vaccine designed to target poly N-acetyl glucosamine (PNAG), a substance found on the surface of a wide range of bacterial, fungal, and parasitic pathogens. In pre-clinical studies, targeting PNAG has shown effectiveness in preventing and treating infections caused by over 15 different pathogens. A phase I, first-in-human trial has been completed, demonstrating that AV0328 is well-tolerated with no serious adverse events observed. The vaccine induced antibodies capable of killing a wide range of PNAG-expressing pathogens, reaffirming its potential as a broad-spectrum antimicrobial solution. ]]> <![CDATA[Biopharma Industry in India: Role of International Partnerships]]> https://biospectrumindia.com/features/95/25191/biopharma-industry-in-india-role-of-international-partnerships.html https://biospectrumindia.com/features/95/25191/biopharma-industry-in-india-role-of-international-partnerships.html Wed, 11 Sep 2024 00:00:00 +0530 The Indian biopharmaceutical industry, recognised as a crucial pillar of the nation's economy, has advanced in recent years. It has extensive capabilities in areas such as drug discovery, development, manufacturing, and research. Yet, to meet the ever-growing challenges and opportunities of the global marketplace, it requires widespread network of international collaborations. Whether it involves the sharing of scientific knowledge, augmenting manufacturing competencies, enhancing foreign direct investments, or promoting technology partnerships, these international alliances will serve as the driving force in pushing the Indian biopharma industry towards realising its full potential on a global scale.   Sharing of Scientific Knowledge and Manufacturing Expertise International collaborations are a critical avenue for accessing diverse scientific expertise and state-of-the-art manufacturing practices. Indian biopharmaceutical industries have benefited significantly from the sharing of scientific and manufacturing knowledge from international partners. This has been possible due to exchange programs, partnerships, and collaborations over the years. Such collaborations have led to the transfer of knowledge on developing innovative therapies, advanced manufacturing practices, and superior quality control mechanisms. International pharmaceutical giants such as Novartis, Johnson & Johnson, and GlaxoSmithKline have research collaborations in India on various healthcare projects. The manufacturing industry benefits most through a synthesis of indigenous practices and foreign expertise. The sharing of innovative manufacturing technologies and adherence to internationally accepted standards are benefits accrued from such collaborations. A case in point is the strategic tie-up between India's Dr. Reddy's Laboratories Ltd and Germany's Merck Serono to co-develop a range of biosimilar compounds. This partnership exemplifies how collaborations can ensure not only high manufacturing standards, but also cost-effectiveness. Moreover, this sharing of expertise has been instrumental in achieving operational efficiency, enhancing productivity, and in turn, higher profitability. It has also allowed Indian biopharma industries to comply with international quality standards and regulations. For instance, Indian vaccine manufacturers such as Serum Institute of India (SII), Bharat Biotech, Zydus, and Biological E have significantly improved their production capacities, leveraging foreign partnerships and technical knowledge sharing. In the scientific realm, such cooperation involves partnerships in research projects, exchange of scientific materials, and researcher mobility. For instance, the joint research programs between the Council of Scientific and Industrial Research (CSIR), GOI and European Molecular Biology Organization (EMBO) improve knowledge exchange and promote capacity building.   Augmenting Foreign Direct Investments (FDI) Foreign Direct Investments play an essential role in driving the growth curve of India's biopharma sector. FDIs provide the industry with much-needed capital, enhancing resources for research and development, facilitating technological advances, and enabling capacity building for manufacturing activities. The Indian government’s continuous efforts to ease FDI policies in the pharmaceutical sector have resulted in a substantial influx of funds. The ever-growing biopharma sector has received significant investments from international players like Merck and Pfizer. This increase in FDIs has helped the sector innovate, excel, and grow, thus contributing positively to India's economy.   Boosting Technology Partnerships The technology-intensive nature of the biopharma sector makes it dependent on persistent technological advancements to gain a competitive advantage. Here, international technology partnerships come to the forefront. These collaborations allow Indian industries to access advanced technology, promote innovation, and stay ahead in the global market. Notably, partnerships between Indian companies and their American and European counterparts have proven fruitful. These collaborations have helped Indian organisations gain access to innovative biotech technologies and practices, which invariably heighten their competitive leverage at an international level. Technology transfers have improved good manufacturing practices (GMP), increased efficiency and productivity, imparted robustness in product development, and made Indian biopharma industries more profitable and resilient.   Additional Benefits Aside from the multiple advantages already discussed, global partnerships hold the promise of added benefits as well. For instance, they help ensure compliance with rigid international regulatory standards which also enables Indian companies to navigate complex intellectual property landscapes and develop effective strategies for product patenting. Moreover, collaborations often result in the transfer of tacit knowledge, which significantly fosters the skill development and growth of the Indian biopharma workforce. International collaborations also equip Indian companies with the necessary tools and knowledge to navigate the complex scenes of intellectual property rights, paving the way for effective strategies surrounding product patent applications. Such exchanges foster a comprehensive development of skills for the Indian biopharma workforce, preparing them for the international arena. In essence, it is evident that international collaborations stand as a critical catalyst in the transformation of the Indian biopharma industry. In an ever-globalizing world, fostering international partnerships is expected to remain a strategic priority for the comprehensive growth, development, and global success of the Indian biopharma industry.     About Gubbi Labs Gubbi Labs is a private research collective that works on various domains ranging from sustainable ecosystems to liveable settlements.  As part of its science communication initiative, it runs Research Matters, a multilingual science news portal.   About Cactus Communications Cactus Communications is a science communication and technology company, accelerating scientific advancement by making science globally accessible.     Click here for the next part of the report- Conclusion & Way Forward ]]> <![CDATA[Redefining Boundaries with Bio-manufacturing: Transforming India's Biopharma Industry]]> https://biospectrumindia.com/features/95/25190/redefining-boundaries-with-bio-manufacturing-transforming-indias-biopharma-industry.html https://biospectrumindia.com/features/95/25190/redefining-boundaries-with-bio-manufacturing-transforming-indias-biopharma-industry.html Sat, 07 Sep 2024 00:00:00 +0530 The emerging wave of global industrial revolution is coalescing around the prospects of greener, cleaner, and more sustainable practices offered by advanced biotechnology. With the staggering projection for the bioeconomy sector, India is positioned at the helm of this revolution. The Government of India's forward-looking policies and programmes such as the Department of Biotechnology's initiative on "Fostering High Performance Biomanufacturing" has set the stage for this. Alongside, industries in the biopharma sector offer promising prospects in the nation's shift toward circular bioeconomy. India’s bio-manufacturing capabilities are primarily anchored in synthetic biology, genome editing, metabolic engineering, among other advanced tools. These represent a "plug and play" model for Industry 4.0, central to the nation’s vision of creating a green, clean, and prosperous India. Bio-foundries, with their high-throughput capabilities to build and strengthen a Design-Build-Test-Learn (DBTL) approach, are expected to provide the much-needed infrastructure for this transformative shift. Through such initiatives, India aims to develop tools and datasets for rational strain improvement in bio-manufacturing. One of the unique aspects of this is the inclusion of BioAI – Bio-Artificial Intelligence though AI hubs. It envisages supporting an AI-powered platform for microbial engineering for industrial scale synthesis of small molecules. More than 2000+ microbial strains has been identified for their commercially relevant features and preserved in national laboratories. In addition, generating datasets on multi-omics datasets, computational workflows for processing and integration of these are envisaged. Complimented by metabolic maps and microbial cell factories, they would all ultimately leverage cloud-based AI platform for microbial engineering, shared Dr Rajesh Gokhale, Secretary, Department of Biotechnology, Government of India in a recent meeting held in Bengaluru. Among various industrial sectors touted to benefit from bio-manufacturing, the biopharma industry presents significant potential. Through the production of biopharmaceuticals, biomanufacturing can transform the entire lifecycle from production to treatment of diseases and healthcare delivery in India. Biopharmaceuticals can target specific molecular pathways, providing more effective and precision-based treatments. The production processes are also more sustainable and can be scaled up effectively to meet increasing demand. Moreover, fermentation-based bio-manufacturing units using enhanced microbe factories can produce sustainable and cost-effective biopharmaceuticals. These bio-manufacturing units use materials considered as waste, such as sugar, biomass, and other biogenic wastes as raw material, thus aligning with the principles of circular economy. This sustainable approach can significantly reduce production costs and environmental footprint. The bio-manufacturing initiative aligns seamlessly with the "Lifestyle for the Environment (LiFE)" programme launched by the Prime Minister of India Narendra Modi, which advocates green, environmentally friendly lifestyle solutions. In a world striving for sustainability and battling climate change, biomanufacturing presents a great potential, especially in sectors like biopharma. As India embraces this green revolution, it will not only meet growing consumer needs but also bolster the nation’s competitive edge both scientifically and economically. The bio-manufacturing landscape in India is set to redefine the future of its industries – fostering a cleaner, greener, and sustainable civilisation.       About Gubbi Labs Gubbi Labs is a private research collective that works on various domains ranging from sustainable ecosystems to liveable settlements.  As part of its science communication initiative, it runs Research Matters, a multilingual science news portal.   About Cactus Communications Cactus Communications is a science communication and technology company, accelerating scientific advancement by making science globally accessible.     Click here for the next part of the report: Role of International Partnerships ]]> <![CDATA[Indian Immunologicals unveils paediatric dose of indigenous hepatitis A vaccine, Havisure]]> https://biospectrumindia.com/news/95/25115/indian-immunologicals-unveils-paediatric-dose-of-indigenous-hepatitis-a-vaccine-havisure.html https://biospectrumindia.com/news/95/25115/indian-immunologicals-unveils-paediatric-dose-of-indigenous-hepatitis-a-vaccine-havisure.html Thu, 05 Sep 2024 00:00:00 +0530 Hyderabad-based Indian Immunologicals Limited (IIL) has announced the launch of its latest breakthrough- the paediatric dose of India's first indigenous Hepatitis A vaccine, Havisure (0.5 ml). This launch marks a significant milestone in IIL's ongoing commitment to providing affordable and effective vaccines for all, especially for the most vulnerable sections of society, particularly children. Hepatitis A is a highly contagious liver infection caused by the Hepatitis A virus, which predominantly affects children and can lead to severe health complications. Vaccination is the most cost effective yet efficient method to prevent the disease. Addressing on the occasion, Dr K. Anand Kumar, Managing Director of Indian Immunologicals Limited, said, "We are delighted to introduce the paediatric dose of Havisure, the first indigenously developed Hepatitis A vaccine in India. IIL is the single largest contributor to the self-sufficiency of vaccines in the country, this launch is a testament to IIL's unwavering dedication to innovation and public health." In line with its commitment to public health and social responsibility, IIL marked this significant launch with a series of community-focused activities. IIL organised free Hepatitis A vaccination drives for children in two orphanages in Hyderabad to start with, which includes one specifically for blind children. IIL also conducted a health awareness session at an old age home, and these are continuous efforts towards creating awareness and better health for the community at large. The launch of Havisure reinforces IIL's long-standing commitment to innovation and public health, solidifying its position as the only company in India to develop an indigenous Hepatitis A vaccine, available in both 0.5 ml and 1 ml dosage forms for paediatric and adult use, respectively. ]]> <![CDATA[Biopharma Industry in India: Emerging Technologies]]> https://biospectrumindia.com/features/95/25189/biopharma-industry-in-india-emerging-technologies.html https://biospectrumindia.com/features/95/25189/biopharma-industry-in-india-emerging-technologies.html Wed, 04 Sep 2024 00:00:00 +0530 The rapidly evolving technological landscape has brought significant benefits to various sectors. In particular, the biopharma industry has experienced a plethora of advancements that have helped reshape its development and growth, especially in countries like India. Advances in areas such as gene editing, nanotechnology, stem cell research, and synthetic biology, among many others, have established a new framework for the biopharma industry in India. Emerging technologies, from artificial intelligence to genomics, are persistently reshaping India's biopharma industry, encouraging new research avenues, accelerating product development, improving supply chains, and enhancing the sector's global competitiveness. Advancements in the field of genomics are revolutionising the Indian biopharma industry. Next-generation sequencing technologies have allowed researchers to gain in-depth insights into the genetic makeup of diseases. Some of the hereditary cancer syndromes, certain cardiovascular diseases (hypertrophic cardiomyopathy, long QT syndrome, familial hypercholesterolemia, and others), neurogenetic diseases, rare genetic diseases, are some of the diseases that the next generation sequencing can help in screening. This understanding has accelerated the development of targeted therapies, including personalised medicine. Genomics is empowering biopharma companies not only to understand diseases better but also to create effective and more personalised treatments. The Genomics for Understanding Rare Diseases India Alliance Network (GUaRDIAN) is one of the initiatives in India using genomics to understand the genetic origins of rare diseases. In recent years, emerging technologies such as cell and gene therapy have become pivotal in shaping the paradigm of the biopharma industry, fostering revolutionary changes in the field of medical biotechnology. Unleashing promising potential for combating life-threatening diseases like cancer, Alzheimer's, and many genetic disorders, these new-age orchestrators are changing the conventional medical landscape of India. Gene therapy and cell therapy are at the forefront of biomedical innovation, holding the potential to treat, and even cure, numerous lethal diseases. While cell therapy is an intervention technique where functional cells are introduced into a patient's body to replace or repair damaged tissues or cells, gene therapy aims to modify or manipulate the expression of a gene or to alter the biological properties of living cells for therapeutic use. Both interventions are enabling a transition from traditional pharmaceuticals to complex and innovative treatment methods, significantly impacting the biopharma industry. An emerging way to treat cancer is immunotherapy, where the patient’s immune system is strengthened to attack cancer cells . It is less painful than surgery, chemotherapy, or radiation therapy, and is known to lower the relapse of cancer. Specialised killer cells, called 'T-cells' in the human immune system, protect our body from cancer and other diseases. They can recognise tumours and cancerous growths destroy them. In advanced stages, cancer cells can inactivate T-cells or modify themselves in a way that cannot detect them. A new approach in immunotherapy, known as CAR T-cell therapy, restores the ability of the T-cells to recognise the cancer cells and kill them.Chimeric Antigen Receptors or CARs are proteins that assist T-cells in recognising and attaching to a specific protein or antigen, present on cancer cells. The interaction between these two proteins leads to the destruction of the cancer cell. First introduced in 2017, the CAR T-cell technology holds promise for the treatment of cancers, especially leukaemia. Now, researchers at the Indian Institute of Technology Bombay (IIT Bombay) have developed a patented technology to leverage the patient’s immune system to cure cancer. Prof. Rahul Purwar and his team of scientists from the Department of Biosciences and Bioengineering, IIT Bombay, have used a combination of gene therapy and cell therapy to modify the immune cells to attack and kill cancer cells. They have secured a patent for their approach and in collaboration with Prof Gaurav Narula of the Tata Memorial Hospital. Taking this research to market, the researchers have incubated a company at IIT Bombay, called ImmunoACT to provide CAR-T cell therapy services commercially . The Indian biopharma industry is steadily embracing the advancements in cell and gene technology. The Government's impetus through the Department of Biotechnology’s "National Biopharma Mission", launched in collaboration with the World Bank, has significantly contributed to the development and commercialisation of cell and gene therapies in India. These therapies are becoming a focal point for investment, innovation, and commercialisation in the biopharma sector. Several startups and established pharmaceutical companies in India are focusing on these innovative technologies, leading to strategic alliances and collaborations between organisations and research institutions to expedite development and distribution. The introduction of gene and cell therapies into the Indian pharma market is also challenging the traditional clinical pathway. Regulatory bodies are required to respond promptly and devise guidelines and policies that are fit for purpose for these novel therapy types. A collaborative effort between regulatory bodies, pharmaceutical companies, and stakeholders is poised to develop comprehensive protocols that ensure novel biopharmaceuticals' safety and efficacy. Furthermore, entering the domain of cell and gene therapy also prompts the necessity for specialised manufacturing capabilities. The quality control checks and balances for these therapies vary significantly from the ordinary pharmaceutical products – demanding high-purity manufacturing spaces, experienced workforce, and advanced analytical testing capabilities. Some of the Indian biopharma companies like ImmunnoACT, Immuneel and Biocon have already geared up to address these challenges. The potential market for cell and gene therapies is vast. With the leap being made from generics to cell and gene therapies, Indian pharmaceutical enterprises will break new ground, ushering in a new era for the country's biopharma industry. With state-of-the-art research, sound clinical trials and data, and consistent regulatory efforts, gene and cell therapies stand to transform India's biopharma landscape, enhancing the healthcare sector's ability to treat chronic and life-threatening diseases. Stem-cell technology is yet another game-changing technology that is influencing biopharma in India. Stem cells have shown potential in treating diseases which were previously considered incurable. Indian biotech companies such as Reliance Life Sciences and Lifecell have heavily invested in stem cell technology. Lifecell, a hallmark company in this niche, provides umbilical cord blood stem cell banking – a service that allows individuals to store stem cells at birth for potential future use. Synthetic biology, described as the design and construction of novel artificial biological pathways, is a relatively new concept in India. However, it presents significant potential for the biosimilar and biopharmaceutical industry, offering avenues for the creation of high-value pharmaceutical products. Indian companies are leveraging synthetic biology in the production of ingredients for the pharmaceutical, nutraceutical, and cosmeceutical industries. Another crucial emerging technology is the Internet of Things (IoT). IoT technologies are creating interconnections between tools, machines, and people, enabling data sharing in real-time. For instance, IoT has been instrumental in enhancing supply chain management in the biopharma industry, ensuring temperature control of sensitive drugs during transport, and offering real-time visibility and traceability, thus minimising risks associated with mishandling during transit. Indian pharma industry is increasingly implementing IoT to track and trace the supply chain logistics for pharmaceutical products, negating the threat of counterfeit drugs. In addition, there are also ecosystem enabling players like the Centre for Cellular and Molecular Platforms (C-CAMP), Atal Innovation Centre at the Centre for Cellular and Molecular Biology (CCMB), and Bangalore Bioinnovation Centre, who are providing a host of support of services like analytical services, R&D services, incubation, seed funding and prototyping. In summary, emerging technologies are driving significant advancements in the Indian biopharma industry, thereby positively influencing the global competitive landscape. Elements such as genomics, cell and gene therapy, stem-cell technology, synthetic biology, and IoT are not only improving operational efficiencies but also enhancing patient care through better diagnosis and treatment techniques. It is an exciting time for India's biopharma industry, as the fusion of biology and technology could serve as the springboard for exponential growth.       About Gubbi Labs Gubbi Labs is a private research collective that works on various domains ranging from sustainable ecosystems to liveable settlements.  As part of its science communication initiative, it runs Research Matters, a multilingual science news portal.   About Cactus Communications Cactus Communications is a science communication and technology company, accelerating scientific advancement by making science globally accessible.     Click here for the next part of the report: Redefining Boundaries with Bio-manufacturing: Transforming India's Biopharma Industry ]]> <![CDATA[Biopharma Industry in India: Vaccines]]> https://biospectrumindia.com/features/95/25188/biopharma-industry-in-india-vaccines.html https://biospectrumindia.com/features/95/25188/biopharma-industry-in-india-vaccines.html Fri, 30 Aug 2024 00:00:00 +0530   Vaccine manufacturing is a critical aspect of the health sector that has received significant attention over recent years, primarily exacerbated by the global health crisis. With the increasing demand and urgency of vaccine production, several significant revolutions, particularly centred on technology, have transformed the operation and efficiency of vaccine production. India, being one of the largest vaccine manufacturers globally, plays a pivotal role in this realm. Indian pharmaceutical companies such as Serum Institute of India and Bharat Biotech have widely used these technological innovations to upscale their production capabilities, thus contributing to the much-needed requirement of vaccine doses globally. Flowing with the wave of technology, India has rolled out vaccines for COVID-19 in record time, further demonstrating the country's prowess. During the pandemic, India demonstrated its agility by scaling up vaccine production rapidly. Equitable access to vaccines was ensured through resilient supply chains and logistics. India's commitment to global health equity is exemplified by its participation in international vaccine initiatives. The country has played a significant role in initiatives like Gavi, the Vaccine Alliance, and the Global Polio Eradication Initiative, aiming to provide affordable vaccines to vulnerable populations and eradicate diseases. India, supplied 242 million low-cost and high-quality vaccines to 101 countries, embodying the spirit of Vasudhaiva Kutumbakam (the world is one family)[1]. Over the last two decades, Indian pharmaceutical companies invested heavily in vaccine manufacturing. India dominates the production of vaccines for diseases like measles, BCG, and DPT. Approximately 90% of the global demand for measles vaccines is met by India. India supplies around 60% of the world’s vaccine demand. The World Health Organisation (WHO) sources 65-70% of its vaccine requirements from India. Several factors have contributed to India's prominence. This strategic position can be attributed to a robust enterprise ecosystem, favourable government policies, and the increasing adoption of emerging technologies aiding vaccine development. The country has become a global hub to produce vaccines, supplying low-cost, high-quality products worldwide as an outcome of these multiple enabling factors. India has embraced technology trends in vaccine manufacturing and focused on capacity building. This includes advancements in cGMP (Current Good Manufacturing Practices), implementation of quality assurance processes, and collaboration with international organisations. As a result, Indian vaccine manufacturers have been able to comply with stringent regulatory standards and export vaccines to countries worldwide. Indian vaccine manufacturers have forged strategic alliances and research collaborations with global pharmaceutical companies, research institutions, and international organisations. Such partnerships have helped in technology transfer, knowledge sharing, and research collaborations, enhancing India's vaccine manufacturing capabilities.   Technology trends in Vaccine Development Technological advancement in the biopharmaceutical sector is a driving force propelling vaccine development to unprecedented heights. Amid this backdrop, India, often referred to as the ‘Pharmacy of the World,’ harnesses its robust vaccine manufacturing capabilities to address global public health problems. With the advent and proliferation of biotechnology, the last decade has witnessed an array of technological trends transforming the vaccine development landscape in India. Investment in research and development is another key aspect bolstering these technological advancements. The industry focuses not just on enhancing the current platforms, but also on the discovery and development of novel technologies. For example, Indian firms are researching the development of mRNA vaccines, a cutting-edge technology harnessed in the COVID-19 vaccines developed by Pfizer-BioNTech and Moderna. These trends have revolutionised not just the research and development processes, but also production, quality assurance, and distribution. Some of the technological trends that shape vaccine development in India are explored in the following sections.   Molecular Techniques and Advancements In traditional vaccine development, pathogens are typically grown in labs, and then weakened or killed to stimulate an immune response. However, recent technological advancements have allowed for more targeted and efficient vaccine development. Molecular techniques like DNA recombination and protein engineering are significant technological trends that have driven the development of recombinant vaccines such as those against Hepatitis B and HPV in India. Cell Culture Technology Cell Culture Technology has offered novel methods to develop vaccines. Traditional vaccine manufacturing often involved growing viruses or bacteria in eggs or animals. However, modern techniques using cell culture and recombinant DNA technologies have been developed. This technology allows for more controlled and scalable vaccine production, addressing the urgent need for volume production of vaccines during outbreaks such as COVID-19. This approach enables efficient vaccine production by growing cells in culture, eliminating the need for eggs or animals as hosts. This method facilitates a more flexible and cost-effective process with higher production yields. Several leading biopharmaceutical entities in India like Stells Biopharma, Sartorius, Lupin, Jubilant Biosys, Syngene, among others have adopted this approach, leading to more efficient vaccine production processes. High-Throughput Screening Techniques High-throughput screening (HTS) techniques have emerged as a powerful tool enabling the rapid identification of candidate vaccine antigens. These techniques allow researchers to screen thousands of drug candidates simultaneously. HTS has the potential to streamline the extensive and at times uncertain process of vaccine development, thereby increasing the efficiency and output of the biopharma industry in India. Nanotechnology The application of nanotechnology in vaccine development is another technological trend in India’s biopharma industry. Nanoparticles can be engineered to mimic viruses, thereby safely inducing a strong immune response. This technology enables the targeted delivery of vaccines, reducing potential side effects, and enhancing the efficacy of the immune response. Indian biopharma industries have shown a keen interest in exploiting these benefits in their vaccine development efforts. Continuous Flow Processing Batch processing was traditionally employed in vaccine manufacturing, with each batch being subjected to independent testing and validation. However, there is a perceptible move towards continuous flow processing. Unlike batch processing, continuous flow systems allow raw materials to enter the system without stoppages. This real-time operation significantly enhances efficiency and reduces production times. With the ability to monitor and adjust the production process instantaneously, this technology is paramount for ramping up vaccine production to meet the escalating demand during emergencies such as the ongoing COVID-19 pandemic. Integrative Manufacturing The traditional vaccine manufacturing process is often segmented into various stages like cell culture, downstream processing, purification, and formulation. The move towards integrative manufacturing highlights a trend in vaccine production where different stages are interconnected and streamlined. This manufacturing model, propelled by automation, seeks to reduce human errors, enhance efficiency, and expedite the output.   The Future of Vaccine Development in India While these technological trends have undeniably boosted vaccine development in India, support from the GOI has been immense. The GOI actively fortifies its biopharma sector with schemes aiming at strengthening the pharmaceutical industry and encouraging innovation. The Production-Linked Incentives (PLIs) scheme fosters vaccine development using emerging technologies with financial overlays planned to spur capacity expansion. Furthermore, global partners such as the USA, Japan, and Australia are also collaborating and aiding India in enhancing its vaccine manufacturing capacities. Additionally, the accessibility and affordability of these technologically advanced vaccines for the vast Indian population are matters of concern. Nonetheless, with continuous technology advancements, strong investment, strategic policies, and collaboration amongst stakeholders, India’s biopharma industry is set to revolutionise vaccine production and distribution. As evident in the handling of the COVID-19 pandemic, techno-scientific advancements have robust potential in addressing global health crises, thereby strengthening India’s position on the global health map. The intersectionality of technology and vaccine manufacturing is evident in India’s biopharma industry. This fusion is propelling an unprecedented pace of innovation in vaccine development. The continuous investment in research and adoption of novel technologies coupled with the government’s supportive initiatives makes India a beacon in global vaccine manufacturing. As the future unfolds, India’s prowess will impact the worldwide effort against infectious diseases and assure a healthier future for all.    [1] India’s vaccine manufacturing prowess (investindia.gov.in)           About Gubbi Labs Gubbi Labs is a private research collective that works on various domains ranging from sustainable ecosystems to liveable settlements.  As part of its science communication initiative, it runs Research Matters, a multilingual science news portal.   About Cactus Communications Cactus Communications is a science communication and technology company, accelerating scientific advancement by making science globally accessible.     Click here for the next part of the report: Emerging Technologies ]]> <![CDATA[Biocon Biologics secures market entry for Bmab 1200 in Europe, UK, Canada, and Japan]]> https://biospectrumindia.com/news/95/25081/biocon-biologics-secures-market-entry-for-bmab-1200-in-europe-uk-canada-and-japan.html https://biospectrumindia.com/news/95/25081/biocon-biologics-secures-market-entry-for-bmab-1200-in-europe-uk-canada-and-japan.html Thu, 29 Aug 2024 00:00:00 +0530 Biocon Biologics Ltd (BBL), a fully integrated global biosimilars company and a subsidiary of Bengaluru-based Biocon, has signed a settlement and license agreement with Janssen Biotech Inc., Janssen Sciences Ireland, and Johnson & Johnson (collectively known as Janssen) that clears the way to commercialise its Bmab 1200, a proposed biosimilar to Stelara, in Europe, the United Kingdom (UK), Canada, and Japan. Under the terms of this settlement agreement, Biocon Biologics has resolved patent disputes with Janssen to secure market entry dates in Europe, the UK, Canada, and Japan. Regulatory filings in these markets are currently under review. Biocon Biologics earlier announced a settlement agreement in the United States for a Bmab 1200 launch no later than February 22, 2025, once approved by the US FDA. The US FDA has accepted the company's Biologics License Application (BLA) for Bmab 1200 (bUstekinumab) for review under the 351(k) pathway. Shreehas Tambe, CEO & Managing Director, Biocon Biologics Ltd, said, "This settlement agreement is testament to our proven track record of science and innovation and is another key milestone in our journey to bring our biosimilar Bmab 1200 (bUstekinumab) to global markets. Bmab 1200 will significantly strengthen our immunology franchise, enabling us to offer an affordable and effective treatment option for patients impacted by autoimmune diseases." Stelara (Ustekinumab) is a monoclonal antibody medication that prevents abnormal regulation of interleukin IL-12/23 associated immune diseases and has been approved for the treatment of psoriasis, Crohn's disease, ulcerative colitis, plaque psoriasis and psoriatic arthritis. The reference brand, Stelara, had worldwide sales of $10.85 billion in 2023.   ]]> <![CDATA[Biopharma Industry in India: Trends in Technology]]> https://biospectrumindia.com/features/95/25067/biopharma-industry-in-india-trends-in-technology.html https://biospectrumindia.com/features/95/25067/biopharma-industry-in-india-trends-in-technology.html Wed, 28 Aug 2024 00:00:00 +0530 The biopharma industry in India has been growing at a considerable rate with the constant development of new and emerging technologies. The transformation of Indian pharmaceuticals industry into biopharmaceutical industry stands as a testimony to this change.  The growth was fuelled by changes in policy, the rise in third-party manufacturing and outsourcing activities, the strategic acquisition and partnerships with foreign entities, India's proficiency in reverse-engineering patented drugs, and its efforts to adhere to the World Trade Organization's (WTO) Trade-Related Aspects of Intellectual Property Rights (TRIPs) commitments and complimented by adopting to latest technological trends. Before India entered the WTO in 1995, its pharmaceutical exports were below $600 million in value. A decade later, in 2005, export values soared to $3.7 billion, making up over 61 percent of the pharmaceutical industry's revenue[1]. This shift towards more complex and high-value biological drugs began over the past two decades as outcome of the above changes. In recent years, biologics and biosimilars have emerged as crucial components of the healthcare sector, offering novel treatment options for various diseases. Vaccines also play a vital role in public health by preventing the spread of infectious diseases and saving countless lives worldwide. In addition, certain emerging technologies like cell and gene therapies are ushering a new era for biopharma industry in addressing the global healthcare challenges. Over the past decade, biologics and biosimilars have taken centre stage in medical advancements. Their potential in treating diseases previously considered untreatable, such as certain types of cancer, autoimmune disorders, and rare genetic conditions, has changed the face of healthcare. India, with its robust biotechnology and information technology sectors, has embraced this shift and is making significant strides in the development and manufacturing of biological drugs. Some of the significant trends in development of biopharma industry in India are predominantly bio-contract development and manufacturing organisations (CDMOs), harnessing artificial intelligence and data analytics, and regulatory reforms. The key trends that are shaping this exciting and transformative niche in India's biopharma sector are explored in these chapters.   Emergence of Bio Contract Development and Manufacturing Organisations Over the years, India has made a significant place for itself on a global scale in the production of generic drugs. The transition has been marked by the emergence of bio–Contract Development and Manufacturing Organisations (CDMOs), mirroring trends in China and South Korea. These organisations play a crucial role in helping companies develop and commercialise their products, offering comprehensive services from drug formulation and development to manufacturing and regulatory submissions, thus playing a pivotal role in biologics, biosimilars and vaccine production and supply chain. CDMOs play an indispensable role in biologics and biosimilars production and their supply chain in India. Indeed, the country is transitioning from being primarily a generics powerhouse towards becoming a hub for high-value drugs. This transition from being predominantly generic to focusing on advanced biologics is significantly altering the market dynamics. The increased use of CDMOs can impact the speed of biologics and vaccine development, as these organisations can provide a multitude of services at one location, from initial development to full-scale manufacturing. As such, they are shaping a new era in biologics and vaccine development in the region.   Growth and contribution of Indian bio-CDMOs The Biologics CDMO Market size is expected to grow from $13.58 billion in 2023 to $24.77 billion by 2028, at a CAGR of 12.78% during the forecast period (2023-2028)[2]. This growth is driven by an increasing number of companies within the pharmaceutical sector considering outsourcing services. In India, domestic formulations by CDMOs are projected to grow at a CAGR of 14% by FY25[3]. Indian CDMOs have built world-class facilities to cater to global business requirements[4]. They have been helping develop innovative therapies and have asserted themselves as world-class chemistry-service providers[5]. They play a critical role in the biopharmaceutical ecosystem and are already contributing to the development of novel biopharmaceuticals[6]. They also play a significant role in the production of small-scale clinical batches to large-scale commercial production.   Harnessing the Power of Artificial Intelligence and Data Analytics The integration of artificial intelligence (AI) and machine learning (ML) in enhancing our understanding of diseases and vaccine development is another transformative trend observed in the Indian biopharma industry. Leveraging India's IT prowess, AI-driven pharmaceutical innovations are expected to lead the way forward. India's vast clinical trial data can be analysed using innovative AI techniques for secondary data analysis, accelerating the drug discovery process. AI and ML can collate and analyse massive amounts of data to predict antigenic shifts, thereby accelerating vaccine development. AI technology was notably deployed in the development of the COVID-19 vaccines, where it played a crucial role in rapidly identifying the coronavirus genome structure, enabling scientists to develop vaccines in record time. Moreover, AI algorithms have the potential to enhance patient stratification, tailoring treatments in an unprecedented manner, thereby providing personalised medicine opportunities. Incorporating AI into biologics, biosimilars and vaccine development is revolutionising the way the industry operates, enhancing efficiency and productivity, and fostering innovative breakthroughs. Additionally, the wealth of clinical trial data available in India provides an invaluable resource for advanced data analysis, offering potential for breakthrough insights and innovations. Furthermore, AI and ML algorithms have expanded the capabilities of R&D in biopharma by easing the identification of disease targets, optimising drug development processes, improving efficiencies, reducing production errors, and contributing to predictive and preventative healthcare.   Regulatory Reforms: Fuelling Innovation Regulatory reforms are a key enabler of innovations. Recognising this, the Indian government has streamlined its processes to facilitate faster approvals of biologics and biosimilars, accelerating the speed-to-market of these critical drugs. Key initiatives, such as the New Drugs and Clinical Trials Rules, have been launched to hasten development and approval processes. A simplified and expedited regulatory process can potentially lead to quicker market access for innovative treatments, benefiting both the industry and patients. The Indian regulatory authority, the Central Drugs Standard Control Organisation (CDSCO)[7], in collaboration with the Department of Biotechnology (DBT), developed “Guidelines on Similar Biologics; Regulatory Requirements for Marketing Authorisation in India” in 2012, which were revised in 2016. This has implemented guidelines for the approval and regulation of biologics including similar biologics (biosimilars)[8], ensuring safety, efficacy, and quality.     [1] The Emergence of India’s Pharmaceutical Industry and Implications for the U.S. Generic Drug Market - U.S. International Trade Commission  (usitc.gov) [2] Biologics CDMO Companies - Market Size, Share & Growth (mordorintelligence.com) [3] The Future of Pharma: Are CDMOs shaping up a more holistic industry (indiatimes.com) [4] The Rise of Biopharmaceutical Outsourcing to Indian CDMOs - BioProcess InternationalBioProcess International (bioprocessintl.com) [5] Big ambitions for India’s contract research firms (acs.org) [6] Frontiers | CDMOs Play a Critical Role in the Biopharmaceutical Ecosystem (frontiersin.org) [7] CDSCO (cdsco.gov.in) [8] Guidelines_on_Similar_Biologics_06_10_2017.pdf (birac.nic.in)             About Gubbi Labs Gubbi Labs is a private research collective that works on various domains ranging from sustainable ecosystems to liveable settlements.  As part of its science communication initiative, it runs Research Matters, a multilingual science news portal.   About Cactus Communications Cactus Communications is a science communication and technology company, accelerating scientific advancement by making science globally accessible.     Click here for the next part of the report: Biologics   ]]> <![CDATA[Biopharma Industry in India: Biologics]]> https://biospectrumindia.com/features/95/25068/biopharma-industry-in-india-biologics.html https://biospectrumindia.com/features/95/25068/biopharma-industry-in-india-biologics.html Wed, 28 Aug 2024 00:00:00 +0530 Biologics is one of the fastest-growing sectors of the pharmaceutical industry. These are large molecule drugs produced from living cells. Unlike chemically synthesised small molecule drugs, biologics are more complex and diverse due to their production from living organisms. These include products such as vaccines, blood components, gene therapies, and recombinant proteins. With the advancement of biotechnological techniques, the production and usage of biologics continue to rise. India has emerged as a key player in the global pharmaceutical landscape and is positioned strategically to become a leading contributor to biologics development.   Technological Trends in Biologics Emerging technologies have revolutionised the biologics manufacturing process. Techniques involving next-generation sequencing, continuous bioprocessing, and automation contribute to a streamlined and more efficient workflow. Next-generation sequencing plays a significant role in innovation within the sector of biologics. Technological breakthroughs in gene sequencing have facilitated the discovery and development of novel biopharmaceuticals by enabling the understanding of different genetic variations and structures. The advent of recombinant DNA technology has revolutionised the production of biologics. It involves the transfer of specific genes into host organisms, enabling the large-scale production of therapeutic proteins. Monoclonal antibodies (mAbs) have become a cornerstone of biologic therapeutics. The development of technologies like hybridoma technology, phage display, and antibody engineering has significantly enhanced the production, specificity, and efficacy of mAbs. Continuous bioprocessing is another technological trend shaping the biologics industry. As compared to traditional batch processing, continuous bioprocessing improves efficiency and product quality by continuously feeding and removing solutions from the bioreactor. The global healthcare landscape is linked to a shift to mRNA technologies. India is not far behind in recognising and investing in this highly promising technology. The country’s biopharma industries are now focusing on mRNA-based therapies, evident in their investments and research activities. The expectation of FDA-approved cancer mRNA vaccines by 2025 has reinforced the crucial nature of mRNA technology, underlying its potential in revolutionising disease treatment methods. Notably, the recent success of mRNA-based COVID-19 vaccines has triggered a resurgence in interest in this technology. Reflecting this global trend, Indian biotech investments are pivoting towards mRNA-based therapies, promising a new era in the treatment of various diseases, including cancer. As this technology matures, it will steer a change in Indian biologics development.   The Future of Biologics in India Essentially, the biologics development landscape in India is being reshaped by a multitude of factors which are altering how biologics are developed and manufactured in the region. Future advancements are expected in this evolving landscape that will continue to drive the industry forward. It is essential to continue studying these trends, understanding their implications, and preparing for the challenges and opportunities they bring. The accelerating growth of biologics development in India is a testimony to the country's commitment to healthcare innovation and patient-centric therapies. Enabled by technological advancements and regulatory support, Indian scientists, researchers, and companies are playing an influential role in shaping this new biopharmaceutical landscape, making strides in healthcare not just for India, but for the global community. A favourable policy ecosystem facilitated by the GOI, complimented by technological adoption, and investments in bioprocessing technologies and incorporating AI and data analytics in the biologics R&D process has poised Indian biopharma ecosystem to contribute significantly. India also has been harnessing partnerships and collaborations with global organisations for knowledge exchange, technology transfer, and capacity building. These collaborations are not only supporting research but also facilitating the integration of Indian biologics with global markets. Through strategic investments, collaborative efforts, and continued focus on research, India is uniquely positioned to be the global epicentre in biologics, leading the way towards accessible, affordable, and innovative healthcare solutions. As technology continues to evolve exponentially, so will India's contribution to the world of biologics and healthcare at large. The biologics sector holds significant promise towards addressing unmet healthcare needs in India and across the globe, and its development is an exciting area to watch as technology continues to advance. Encouragingly, with government support, technological innovation, and industry determination, India is set to carve a prominent role in this arena, leveraging the strength of its pharmaceutical industry.       About Gubbi Labs Gubbi Labs is a private research collective that works on various domains ranging from sustainable ecosystems to liveable settlements.  As part of its science communication initiative, it runs Research Matters, a multilingual science news portal.   About Cactus Communications Cactus Communications is a science communication and technology company, accelerating scientific advancement by making science globally accessible.     Click here for the next part of the report: Biosimilars ]]> <![CDATA[Shilpa Medicare completes Phase 1 trial for Recombinant Human Albumin (rHA) 20%]]> https://biospectrumindia.com/news/95/25069/shilpa-medicare-completes-phase-1-trial-for-recombinant-human-albumin-rha-20.html https://biospectrumindia.com/news/95/25069/shilpa-medicare-completes-phase-1-trial-for-recombinant-human-albumin-rha-20.html Wed, 28 Aug 2024 00:00:00 +0530 In a major breakthrough, Bengaluru-based Shilpa Medicare has announced the successful completion of its Phase 1 clinical trial for its flagship product, sRbumin - recombinant human albumin 20% (rHA), becoming the first Indian company to achieve this milestone. The positive results underscore rHA's potential as a viable alternative to plasma-derived human serum albumin, addressing a critical gap in global healthcare. The Phase 1 clinical study was a randomised, dose-escalating, comparative trial against European-sourced human-derived serum albumin, involving 62 healthy volunteers. It aimed to evaluate the safety, efficacy, and pharmacokinetics of rHA at different dose levels. rHA demonstrated clinical benefits comparable to human-derived albumin in surrogate endpoints such as colloidal osmotic pressure and hematocrit ratio. rHA was generally well-tolerated, with no serious adverse events reported. No significant difference was observed in the incidence of anti-drug antibodies compared to human-derived albumin, and rHA showed bioavailability comparable to human albumin. Human serum albumin is essential for various medical treatments, such as volume replacement therapy for accidents, burns, and surgeries. However, the current supply is heavily dependent on blood donations, leading to potential shortages. Shilpa's rHA, produced using yeast fermentation, offers a highly purified, structurally and functionally equivalent alternative. Building on this success, Shilpa Medicare plans to initiate Phase 3 clinical trials for rHA by Q4 FY25. These trials are expected to be completed within a year, followed by product approval filings in FY26. ]]> <![CDATA[Indian Immunologicals develops first-of-its kind needle-free COVID-19 intranasal vaccine]]> https://biospectrumindia.com/news/95/25064/indian-immunologicals-develops-first-of-its-kind-needle-free-covid-19-intranasal-vaccine.html https://biospectrumindia.com/news/95/25064/indian-immunologicals-develops-first-of-its-kind-needle-free-covid-19-intranasal-vaccine.html Tue, 27 Aug 2024 00:00:00 +0530 Hyderabad-based Indian Immunologicals Limited (IIL), a leading vaccine manufacturer, has announced the development of live-attenuated needle free intra-nasal booster vaccine developed against SARS-CoV-2 using codon deoptimisation technology in collaboration with Griffith University, Australia. This groundbreaking work on Covid-19 vaccine has been published in the world’s leading science Journal ‘Nature Communications’ on 26th August 2024. Among different formats of vaccines available, it is well known that live attenuated vaccine generates a robust and broad-spectrum neutralizing antibody response. IIL’s needle free intra-nasal booster vaccine against SARS-CoV-2 developed using codon deoptimisation technology demonstrated remarkable stability and maintained safety in extensive animal studies. Codon deoptimisation involves decreasing the frequency of underrepresented codon pairs (genetic determinant for amino acids) without changing amino acid sequences. It is a highly efficient virus attenuation strategy that utilises suboptimal codon pairs to achieve attenuation of recoded viruses. Virtually all the viruses can be attenuated by this method.  Speaking on the occasion, Dr K Anand Kumar, Managing Director, Indian Immunologicals Limited said, “This accomplishment signifies a major step forward in our battle against COVID-19. The development of this vaccine not only highlights our dedication to innovation in public health but also demonstrates IIL’s capability in adopting novel technology." Dr Priyabrata Pattnaik, Deputy Managing Director, Indian Immunologicals Limited added, “This is a perfect example of Industry-Academia collaboration translating concepts to products for the benefit of people at large. Our R&D team has dedicated immense effort to the creation of this innovative vaccine, and we take pride in its proven safety and efficacy in generating a protective immune response with just a single dose".   ]]> <![CDATA[ICMR and Panacea Biotec initiate Ph 3 trial of first dengue vaccine in India ]]> https://biospectrumindia.com/news/95/25029/icmr-and-panacea-biotec-initiate-ph-3-trial-of-first-dengue-vaccine-in-india-.html https://biospectrumindia.com/news/95/25029/icmr-and-panacea-biotec-initiate-ph-3-trial-of-first-dengue-vaccine-in-india-.html Wed, 14 Aug 2024 00:00:00 +0530 The Indian Council of Medical Research (ICMR) and New Delhi-based biotech company Panacea Biotec have announced the initiation of the first-ever Phase 3 clinical trial for a dengue vaccine in India. This landmark trial will evaluate the efficacy of India’s indigenous tetravalent dengue vaccine, DengiAll, developed by Panacea Biotec. The first participant in this trial was vaccinated at Pandit Bhagwat Dayal Sharma Post Graduate Institute of Medical Sciences (PGIMS), Rohtak. Currently, there is no antiviral treatment or licensed vaccine against dengue in India. The development of an effective vaccine is complex due to the need to achieve good efficacy for all four serotypes. In India, all four serotypes of Dengue virus are known to circulate or co-circulate in many regions. The tetravalent dengue vaccine strain (TV003/TV005), originally developed by the National Institutes of Health (NIH), USA, has shown promising results in preclinical and clinical trials worldwide. Panacea Biotec, one of three Indian companies to receive the strain, is at the most advanced stage of development. The company has worked extensively on these strains to develop a full-fledged vaccine formulation and holds a process patent for this work. Phase 1 and 2 clinical trials of the Indian vaccine formulation were completed in 2018-19, yielding promising results. In collaboration with ICMR, Panacea Biotec will conduct the Phase 3 clinical trial across 19 sites in 18 States and Union Territories of India, involving more than 10,335 healthy adult participants. The trial, primarily funded by ICMR with partial support from Panacea Biotec, is set to follow up with participants for two years. ]]> <![CDATA[National Biopharma Mission completes 5 years, launches impact book]]> https://biospectrumindia.com/news/95/25008/national-biopharma-mission-completes-5-years-launches-impact-book.html https://biospectrumindia.com/news/95/25008/national-biopharma-mission-completes-5-years-launches-impact-book.html Fri, 09 Aug 2024 00:00:00 +0530 “Bio-Economy and Space Economy are going to spearhead India’s future growth story” says Union Minister Dr Jitendra Singh at the launch of ‘Impact Report 2024’ on National Biopharma Mission at the National Biopharma Mission Conclave celebrating its 5 years journey at the Dr. Ambedkar International Centre, New Delhi. Union Minister of State (Independent Charge) for Science and Technology, Dr Jitendra Singh recalled the journey of National Biopharma Mission since its inception along with Biotechnology Industry Research Assistance Council (BIRAC) “National Biopharma Mission (NBM) is Celebrating 5 Years of Pioneering Success” and called it a milestone. The National Biopharma Mission (NBM)- Innovate in India (I3) is an Industry-Academia Collaborative Mission for Accelerating Discovery Research for development of Biopharmaceuticals. BIRAC has the mandate to enable and nurture an ecosystem for preparing India’s technological and product development capabilities in bio pharmaceuticals, vaccines, biosimilars, medical devices and diagnostics.  The project was sanctioned with a total cost $250 million which is 50% co-funded by the World Bank. Today nearly 150 organisations and 300 MSMEs are being benefited from the programme. NBM has established 21 shared infrastructure facilities for research services and biomanufacturing. These facilities were also leveraged for the COVID-19 vaccine trials during the pandemic and are an important step towards India @2047, saving both cost & time. National Biopharma Mission has supported more than 200 grantees in three main domains: Vaccines, Biotherapeutics & Medical Devices and Diagnostics while also strengthening the ecosystem. The Mission has introduced over 18 successful products to the market including vaccines, biotherapeutics, medical devices, and diagnostic kits. ]]> <![CDATA[Biopharma Industry in India: Growth and Possibilities]]> https://biospectrumindia.com/features/95/24991/biopharma-industry-in-india-growth-and-possibilities.html https://biospectrumindia.com/features/95/24991/biopharma-industry-in-india-growth-and-possibilities.html Mon, 05 Aug 2024 00:00:00 +0530 The Indian economy has seen significant growth over the past few years and is poised to grow at a rate of 7% over the next two years[1]. The BioEconomy sector in particular, has shown immense promise. Over 2020, the Indian BioEconomy sector registered an impressive growth of 14.1%, which accounts for about 2.6% of India’s GDP. The sector was valued at $80.12 billion in 2021, increasing from $70.2 billion in 2020[2]. As one of the largest suppliers of low-cost drugs and vaccines worldwide and home to over 5,000 startups, the Indian BioEconomy sector is poised to reach a value of $300 billion by 2030[3]. India is among the top 12 hubs of biotechnology worldwide, and the third largest destination for biotechnology in the Asia Pacific region. India's biotechnology industry covers several areas, such as biopharma, bio-services, bio-agriculture, bio-industry, and bioinformatics. According to the India BioEconomy Report of 2022, the biopharma segment is the largest contributor to the biotechnology industry in India, with a market share of 49% and total economic contribution of approximately $39.4 billion in 2021. The ever-growing pharmaceutical industry in India produces a range of drugs and formulations, including generic drugs, branded generics, over the counter (OTC) products, active pharmaceutical ingredients (APIs), and contract research and manufacturing services (CRAMS). The industry is also a major exporter of drugs and formulations to several countries, especially emerging markets. According to IBEF[4], this industry is witnessing a surge in innovation and research activities, especially in the areas of new drug discovery, novel delivery systems, biosimilars, and vaccines.     In particular, the biopharma segment develops products such as therapeutics, vaccines, and diagnostics. Of these, diagnostics alone account for 52% ($20.4 billion) share of the total biopharma market, while therapeutics segment account for 26% ($10.3 billion). The vaccine segment (excluding COVID-19 vaccines) account for the rest (22%, at $8.7 billion). The COVID-19 pandemic has had a significant impact on the sector, leading to changes in the dynamics of production capabilities and trade. Prior to the pandemic, the European Union (EU), the United States of America (USA), and India were leading vaccine producers. While vaccines produced by the EU cater largely to economically advanced nations, the US vaccine production served its domestic requirements. In contrast, India supplied vaccines primarily to the economically developing nations. Although India’s export volumes accounted for about a quarter of the global exports, in terms of value, they amounted to less than 2%. These figures can be attributed to India’s focus on producing vaccines at affordable prices and supplying them to developing and low-income countries, as per the India BioEconomy Report. However, India remains the largest vaccine producer only second to the EU, with annual production capacities of around 14.5 million kgs—comparable with that of the EU’s annual production capacities, of around 15.5 million kgs.   Moreover, the Indian in-vitro diagnostics market is one of the leading sub-segments in the diagnostics sector. Its performance has risen owing to factors such as the high prevalence of chronic diseases, increasing use of point-of-care (POC) diagnostics, and rising awareness and acceptance of personalised medicine and companion diagnostics[5]. The biotherapeutics segment is estimated to record higher growth, with diabetes, oncology, infections, and cardiology medication as the primary contributors. With increasing acceptance to Indian made biosimilars in developed markets like the USA, the likelihood that more nations will accept them is higher. Additionally, an increase in the demand for cost-effective biosimilars is poised to grow rapidly. The medical device industry is yet another key segment of the biopharma industry in India. It develops products such as surgical instruments, implants, diagnostic equipment, consumables, and digital health solutions.   According to IBEF, the medical devices industry in India was valued at $11 billion in 2020 and is expected to reach $50 billion by 2025⁵. Drivers of Growth in Indian Biopharma The biopharma industry in India has emerged as one of the leading exporters of generic medicines globally. This has been consistently recording a double-digit growth year-on-year with very impressive market outlook. This rapid growth can be attributed to multiple factors including skilled workforce to government support and extensive research and development activities. India boasts a large workforce of English-speaking scientists and researchers. These professionals, possessing strong capabilities in chemical synthesis and process optimization, play a crucial role in driving research and development activity in the biopharma industry. The biopharma industry is also witnessing a rise in innovation and entrepreneurship, with several start-ups developing cutting-edge technologies and solutions for healthcare needs. The increasing demand for quality healthcare, rising disposable income, growing medical tourism, and favourable government policies are some of the factors responsible for this industry’s growth. The Government of India (GOI) has been upping the ante with key policies, increased budgetary allocation to the sector, and providing a favourable ecosystem at large for this sector. For instance, in the Union Budget 2023–2024, the Department of Biotechnology (DBT) was allotted $162.7 million (Rs 1,345 crore) to support R&D activities in biotechnology. The DBT also implements various programmes and initiatives to foster innovation, entrepreneurship, and collaboration in biotechnology, such as Biotechnology Industry Research Assistance Council (BIRAC), Biotechnology Ignition Grant (BIG), and Grand Challenges India (GCI)[6]. With an aim to promote domestic industries, the DBT has been providing incentives and formulating schemes for the manufacturing of critical bulk drugs, pharmaceuticals, and medical devices. For instance, the Production Linked Incentive (PLI) Scheme for Bulk Drugs and Pharmaceuticals offers financial incentives to eligible manufacturers of identified products for six years[7]. The Scheme for Bulk Drug Parks provides grants-in-aid to states for developing common infrastructure facilities for bulk drug manufacturing units. Furthermore, the GOI has taken steps to create a conducive regulatory environment for the biopharma industry. To this end, it has appointed the Central Drugs Standard Control Organization (CDSCO) as the national regulatory authority for ensuring the safety, efficacy, and quality of drugs and medical devices in India. The CDSCO has streamlined the approval processes and timelines for clinical trials, new drugs, and medical devices, and has introduced provisions for fast-track approval of certain categories of products. The CDSCO also collaborates with other regulatory agencies and international organisations to harmonise the standards and guidelines for the biopharma industry. India’s demographic dividend is also at play here. Given a projected ageing population and the government has been continuously focusing on improving healthcare infrastructure with increased spending on healthcare. Added to this, increasing life expectancy has also boosted the demand for pharmaceuticals and therapies within domestic markets too. The biopharma sector is undergoing a change, moving from recombinant proteins and antibodies to more intricate cell and gene therapies. In order to be globally competitive, a symposium[8] was held in 2021 that was jointly organised by the US Pharmacopeia (USP), the DBT, and the Confederation of Indian Industry (CII). It noted that biomanufacturers must strive to meet international standards in terms of drug quality, decrease production mishaps, and expedite the process of bringing drugs to the market. A panel of experts from academia, manufacturing, and governmental agencies identified several drivers needed for capability building, including a skilled workforce, public–private partnerships, advanced manufacturing technologies, novel biologics, and favourable policies. In summary, the biopharma industry in India is a key contributor to the economic growth and social development of the country. It offers several opportunities for investment, collaboration, and innovation for both domestic and foreign players. It also plays a vital role in addressing the global challenges of health security, pandemic preparedness, climate change, and sustainable development. This report attempts to bring out the drivers of growth of the Indian biopharma industry and capture the trends in technology. The role of international partnerships through collaborations and sharing of scientific and manufacturing expertise will be elaborated in the subsequent sections, in addition to the foreign direct investments and partnerships. The report concludes with a note on the potential growth and prospects of the biopharma industry in India, highlighting the key challenges and how with support from the government and international collaborations, the industry can overcome them.     [1] India economic outlook | Deloitte Insights [2] India_Bioeconomy_Report_2022.pdf (birac.nic.in) [3] Biotechnology Industry in India – Biotech Sector Analysis (investindia.gov.in) [4] Pharmaceutical Companies in India, Indian Pharma Industry- IBEF [5] Cytiva sets up manufacturing facility for biopharma industry | The Financial Express [6] Indian Biotechnology Industry Analysis Presentation | IBEF [7] Government Scheme for Pharmaceuticals Manufacturing | Invest India [8] Biopharmaceutical Industry Capability Building in India: Report from a Symposium | Journal of Pharmaceutical Innovation (springer.com)           About Gubbi Labs Gubbi Labs is a private research collective that works on various domains ranging from sustainable ecosystems to liveable settlements.  As part of its science communication initiative, it runs Research Matters, a multilingual science news portal.   About Cactus Communications Cactus Communications is a science communication and technology company, accelerating scientific advancement by making science globally accessible.     Click here for the next part of the report- Trends in Technology     ]]> <![CDATA[Sanofi receives marketing authorisation for Beyfortus in India to protect children against Respiratory Syncytial Virus]]> https://biospectrumindia.com/news/95/24978/sanofi-receives-marketing-authorisation-for-beyfortus-in-india-to-protect-children-against-respiratory-syncytial-virus.html https://biospectrumindia.com/news/95/24978/sanofi-receives-marketing-authorisation-for-beyfortus-in-india-to-protect-children-against-respiratory-syncytial-virus.html Thu, 01 Aug 2024 00:00:00 +0530 Sanofi (India) has received marketing authorisation approval from the Central Drugs Standard Control Organisation (CDSCO) for Beyfortus in India. Beyfortus contains the monoclonal antibody nirsevimab in a prefilled injection used for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease (LRTD) in newborns and infants born during or entering their first RSV season. It is also administered in children up to 24 months of age, who remain vulnerable to severe RSV disease through their second RSV season. In 2019, there were approximately 33 million cases of acute lower respiratory infections globally, leading to more than 3 million hospitalizations, and it was estimated that there were 26,300 in-hospital deaths of children younger than 5 years. Preeti Futnani, General Manager – Sanofi Vaccines (India) said, “Prevention of RSV in India is still an unmet medical need. This makes the approval of Beyfortus a landmark moment for Sanofi in India. We are prioritising this potential game-changer to make Beyfortus available for all Indian parents to help protect their babies during their first and second RSV seasons.” According to Dr Kuharaj Mahenthiran, Country Medical Head, Sanofi Vaccines (India), “Data gathered from all geographical regions of India (from 1970 to 2020) to assess the burden of respiratory viruses and their prevalence, found RSV to be the most prevalent respiratory virus (29%) followed by Influenza Aix. The CDSCO approval for Beyfortus was based on a clinical programme spanning three pivotal late-stage clinical trials. Across all clinical endpoints, a single dose of Beyfortus demonstrated high and consistent efficacy against RSV LRTD in all infant populations studied. These included babies born healthy at term, late preterm or preterm, or with specific health conditions that make them vulnerable to severe RSV disease. Beyfortus was also well tolerated with a favorable safety profile that was consistent across all clinical trials.” In March 2017, Sanofi and AstraZeneca announced an agreement to develop and commercialize Beyfortus. Under the terms of the agreement, AstraZeneca leads development and manufacturing activities, and Sanofi leads commercialisation activities and records revenues.  Beyfortus has been approved for use in the European Union, the US, China, Japan, and many other countries around the world.   ]]> <![CDATA[Driving towards Biopharma 4.0 - Facility of the Future]]> https://biospectrumindia.com/views/95/24975/driving-towards-biopharma-4-0-facility-of-the-future.html https://biospectrumindia.com/views/95/24975/driving-towards-biopharma-4-0-facility-of-the-future.html Wed, 31 Jul 2024 00:00:00 +0530 The biopharma industry has been on a steady rise, unveiling new potentials and opportunities thanks to the ever-expanding array of molecules and modalities. Yet, with this growth also comes a host of challenges particularly, in terms of developing and bringing these products and treatments to market. Navigating the complexities of developing and delivering these groundbreaking therapies requires not just skill, but a commitment to putting patients first, ensuring their safety and well-being above everything else. This has triggered a fundamental shift in the pharma industry, driven by the need for speed, adaptability, sustainability, and excellence in every stage from research to delivery. To address these current and anticipated challenges, the biopharma industry is increasingly turning to automation and digital technologies that will not just optimise the drug development process, but also enhance manufacturing and improve patient outcomes. Here Industry 4.0 ideas start to win over the biopharma industry. Technologies like process automation, robotics, data analytics, artificial intelligence (AI) and machine learning (ML) etc. are making the industry more efficient and sustainable. With the global biopharmaceuticals market projected to grow from $470.80 billion in 2023 to $799.76 billion by 2030, the Industry 4.0 technologies play a major role in sustaining and maximising this growth. Here’s how Biopharma 4.0 will shape the future of pharmaceutical facilities.   Rise of Biopharma 4.0 The transition of Industry 4.0 principles into bioprocessing space has given rise to Biopharma 4.0, a shift aimed at fostering innovation and heightened efficiency in production facilities. Biopharma 4.0 as a concept is all about harnessing data-driven technologies in biotherapeutic production. Extracting accurate and real-time information through various production and supply channels, and conducting advanced analytics on this data to deliver actionable insights is central to the Biopharma 4.0 ecosystem. According to Precedence Research, the global pharma 4.0 market size was estimated at $14.17 billion in 2023 and it is predicted to reach around $63.29 billion by 2032, growing at a CAGR of 18.1% from 2024 to 2032. This shows a significant trend, where biopharma manufacturers are heading towards adopting more and more Industry 4.0 technologies. With an additional push from the government and FDA, the pharma players are now on track to catch up with other industries. However, we should understand that Biopharma 4.0 is more than a mere goal for the industry; it's a journey that demands a step-by-step approach towards industry-wide acceptance and adoption on multiple levels. Industry players are pouring resources into digital and automation technologies, particularly in commercial manufacturing, where efficiency and compliance are paramount. But there's no one-size-fits-all approach to this transformation, given the intricacies and unique needs of each organisation. At the core of this shift lies data, the heartbeat of automation and digital innovation. While the potential of emerging technologies spans across drug development, manufacturing, supply chain, and marketing, our focus is on how data management and analytics can reshape manufacturing operations in the realm of Biopharma 4.0. It's an ambitious vision, but one that promises to revolutionise how we produce life-saving treatments.   Relevance of Data Analytics in Pharma Accurate data and advanced data analytics have become the key components in the pharmaceutical industry, providing crucial insights across various production aspects. Whether it's monitoring equipment performance, tracking supply chain logistics, or predicting potential production issues, data analytics is instrumental in optimising efficiency and mitigating risks. Data analytics is also the bedrock of the entire Industry 4.0 premise which makes other technologies like AI, machine learning, augmented reality, etc functional. These technologies when fed with accurate data insights can make major breakthroughs for any organisation while propelling a transformative wave across the industry. Where AI algorithms can meticulously analyse vast datasets to refine processes and facilitate drug discovery, digitisation facilitates instantaneous monitoring and control of manufacturing operations. Additionally, the integration of IoT solutions enables remote equipment surveillance and predictive maintenance, effectively reducing downtime and bolstering productivity. Collectively, these technologies underpin Biopharma 4.0, marking the dawn of an era characterised by innovation and operational superiority.   Data Management & Analytics Revolutionising Biomanufacturing in the Era of Biopharma 4.0 Manufacturing of drugs is a complex and time-consuming process that generates massive amounts of data. Effective and efficient management and analysis of this data can extract valuable insights for the organisation that can play a critical role in optimising the biomanufacturing process and improving quality of biopharmaceutical production. As biopharmaceutical companies embrace digital technologies and advanced analytics, the biomanufacturing landscape undergoes a profound evolution, enabling agile, data-driven decision-making and optimization across the entire production lifecycle. Here’s how Biopharma 4.0 is making a difference for the industry: Real-Time Process Monitoring and Control: Biopharma 4.0 leverages advanced data analytics to enable real-time monitoring and control of biomanufacturing processes. Integrated sensors, IoT devices, and process analytical technologies (PAT) generate vast streams of data, providing granular insights into key process parameters and product quality attributes. Analytics platforms analyse this data in real-time, enabling proactive identification of deviations, process optimization, and predictive maintenance to ensure consistent product quality and yield. Predictive Maintenance and Asset Management: Data-driven predictive maintenance strategies optimise equipment performance and minimise downtime in biomanufacturing facilities. Machine learning algorithms analyse historical data and sensor readings to forecast equipment failures, enabling preventive maintenance interventions before issues arise. By proactively addressing equipment maintenance needs, biopharma companies maximise operational efficiency, reduce costs, and ensure uninterrupted production cycles. Quality by Design (QbD) and Process Optimisation: Data analytics empower bio manufacturers to implement Quality by Design (QbD) principles, optimising process parameters and formulations to achieve desired product quality attributes. Statistical process control (SPC) techniques and multivariate analysis enable real-time monitoring of process variability and identification of critical process parameters (CPPs). By leveraging advanced analytics, biopharma companies can design robust manufacturing processes, minimise batch-to-batch variability, and accelerate time-to-market for biologics. Supply Chain Optimization and Demand Forecasting: Data analytics enable biopharma companies to optimise supply chain operations and enhance demand forecasting accuracy. By analysing historical sales data, market trends, and production capacity, predictive analytics models forecast demand for biopharmaceutical products with greater precision. This enables proactive inventory management, reduces stockouts, and minimises excess inventory, ensuring timely product availability while optimising working capital utilisation. Regulatory Compliance and Data Integrity: In the heavily regulated biopharmaceutical industry, data management plays a critical role in ensuring compliance with regulatory requirements and maintaining data integrity. Advanced data management systems implement robust data governance frameworks, audit trails, and electronic batch records (EBRs) to demonstrate compliance with regulatory standards such as FDA's 21 CFR Part 11. By ensuring data accuracy, completeness, and traceability, biopharma companies uphold regulatory compliance and mitigate the risk of non-compliance-related penalties and product recalls.  Predictive and Prescriptive analytics in biomanufacturing: In the realm of biomanufacturing, predictive and prescriptive analytics are powerful tools revolutionising process optimization, quality control, and decision-making. By leveraging historical data, real-time monitoring, and advanced algorithms, biopharma companies can predict future outcomes, identify optimal process conditions, and proactively address potential issues, ultimately enhancing efficiency, quality, and productivity across the biomanufacturing lifecycle. Predictive analytics utilises historical data and statistical algorithms to forecast future outcomes and trends in biomanufacturing processes. By analysing data from various sources such as process sensors, laboratory tests, and production records, predictive models can anticipate potential deviations, process failures, and product quality issues. For example, predictive analytics can forecast equipment failures, enabling preventive maintenance interventions to minimise downtime and ensure uninterrupted production. Prescriptive analytics goes beyond predictive analytics by recommending optimal courses of action to achieve desired outcomes. By combining predictive models with optimisation algorithms, prescriptive analytics identifies the most effective strategies for process improvement, resource allocation, and decision-making. For example, prescriptive analytics can recommend the optimal process parameters to maximise yield while minimising production costs and cycle times. Data Management & Analytics are driving a paradigm shift in biomanufacturing, ushering in the era of Biopharma 4.0. By harnessing the power of real-time process monitoring, predictive analytics, and advanced data management techniques, biopharma companies optimise manufacturing processes, enhance product quality, and improve operational efficiency. As bio manufacturers continue to embrace digital transformation, data-driven decision-making will remain central to driving innovation and maintaining competitive advantage in the dynamic biopharmaceutical landscape. Emerging software such as Bio4C ProcessPad enables bioprocess monitoring, lifecycle management, reporting, investigations, and continued process verification (CPV). It ensures process information is current, complete, and accessible throughout the product lifecycle.   Ashok Kumar, Head of BIO4C Commercial – Merck Life Science (Asia Pacific)  ]]> <![CDATA[Miltenyi Biotec and THSTI collaborate to strengthen R&D in cell and gene therapy]]> https://biospectrumindia.com/news/95/24913/miltenyi-biotec-and-thsti-collaborate-to-strengthen-rd-in-cell-and-gene-therapy.html https://biospectrumindia.com/news/95/24913/miltenyi-biotec-and-thsti-collaborate-to-strengthen-rd-in-cell-and-gene-therapy.html Tue, 16 Jul 2024 00:00:00 +0530 Miltenyi Biotec, a global leader in biomedical solutions, has announced the signing of a Letter of Intent with the Translational Health Science and Technology Institute (THSTI), an autonomous institute of the Department of Biotechnology, Ministry of Science and Technology. With this partnership, both organisations aim to address the growing need for innovative treatments in the fight against cancer by developing innovative cell and gene therapies. The announcement was made during THSTI's 15th Foundation Day Celebrations. The purpose of this collaboration is to focus on leveraging the strengths of both organisations to enhance research and development in cell and gene therapy (CGT) focusing on cancer and sickle cell disease. This collaboration would help in capacity building, technology transfer, training programmes, and joint research initiatives which would then be translated into medical therapies.  The letter of intent was signed by Sivakumar Natarajan - Managing Director (Interim), MiltenyiBiotec, India; Dr Prudwidhar S - Country Medical Affairs Director at Miltenyi Biotec and Prof. Ganesan Karthikeyan, Executive Director, BRIC-Translational Health Science and Technology Institute (BRIC-THSTI) in the presence of Dr Jitendra Singh, Minister of State (IC) Ministry of Science & Technology, Government of India and Dr Rajesh S Gokhale, Director General, BRIC, and Secretary, Department of Biotechnology. “Each year, more than 10,000 patients are treated with cell products using Miltenyi Biotec’s technologies. Through our partnership with THSTI, we aim to help bring new therapies to patients with high unmet medical needs in disease areas where traditional treatments have fallen short,” emphasised Sivakumar Natarajan. Prof G Karthikeyan said, “The partnership with Miltenyi Biotec represents one more step in THSTI’s translational efforts. With our cutting-edge science and expertise in clinical trials, we hope to make tailored, state-of-the-art cancer treatments affordable & accessible to our population.” Miltenyi Biotec was launched in India in February 2024, at the back of BioAsia Summit, held in Hyderabad. ]]> <![CDATA[Agreement to explore Optimer vehicles for targeted delivery of siRNA]]> https://biospectrumindia.com/news/95/24882/agreement-to-explore-optimer-vehicles-for-targeted-delivery-of-sirna.html https://biospectrumindia.com/news/95/24882/agreement-to-explore-optimer-vehicles-for-targeted-delivery-of-sirna.html Mon, 08 Jul 2024 00:00:00 +0530 Aptamer Group plc (AIM: APTA), the developer of novel Optimer® binders to enable innovation in the life sciences industry, is pleased to announce a new agreement with AstraZeneca, a global biopharmaceutical company, to evaluate the Optimer fibrotic liver delivery vehicles for the targeted delivery of siRNA. Following the encouraging results achieved to-date with Aptamer’s fibrotic liver delivery vehicles, the next phase of this research will explore the potential of the non-viral delivery vehicle and its applicability with a tool siRNA. Under the agreement, AstraZeneca will provide an siRNA to be trialled with Aptamer’s Optimer- based delivery vehicle for fibrotic liver cells. Aptamer Group will conduct in-house experimental work to assess the effectiveness of this delivery vehicle with the AstraZeneca’s siRNA. Upon success, Aptamer Group will progress to internally generating demonstrator data in animal models for evaluation by AstraZeneca. Delivery of siRNA to precise cell types and tissues with successful cell internalisation remains a significant challenge for the wider therapeutic application of the technology. Despite this limitation, the siRNA market was still valued at over $13 billion in 2023. Optimer technology could represent a paradigm shift in the targeted delivery of siRNA molecules, due to the high levels of selectivity, high affinity and simple conjugation of siRNA payloads, offered using Optimer delivery systems as non- viral vectors. If successful Optimer-enabled delivery of siRNA could lead to the development of novel compounds that have significant advantages over current cell and tissue-targeting methods. Dr Arron Tolley, Chief Technical Officer of Aptamer Group, said: “We are really excited to work with AstraZeneca to evaluate and optimise our Optimer delivery vehicles. “Partnerships such as this will enable Aptamer Group to make rapid progress in this area, which is a key focus for Optimer technology. Targeted delivery to specific cell types remains a critical unmet need in many applications within the tissue targeting space and, as such, has been part of our strategic focus to support the development of binders with the potential for long-term, high value. Our initial dataset in Optimer targeted delivery has raised significant interest from multiple parties. We are eager to advance to animal model testing and delighted to continue collaborating with AstraZeneca in this endeavour. Reaching proof of principle in animal models will derisk the Optimer delivery platform and bring us closer to delivering targeted and effective gene therapies for patients.” ]]> <![CDATA[Botswana Vaccine Institute engages Techinvention for setting up new veterinary vaccine manufacturing facility]]> https://biospectrumindia.com/news/95/24848/botswana-vaccine-institute-engages-techinvention-for-setting-up-new-veterinary-vaccine-manufacturing-facility.html https://biospectrumindia.com/news/95/24848/botswana-vaccine-institute-engages-techinvention-for-setting-up-new-veterinary-vaccine-manufacturing-facility.html Wed, 03 Jul 2024 00:00:00 +0530 Mumbai-based startup Techinvention Lifecare has been appointed as a consultant by Botswana Vaccine Institute (BVI) to monitor setting up of the new state-of-the-art and cGMP compliant, vaccine manufacturing unit in its existing facility at Gaborone, Botswana. The scope encompasses comprehensive project management role for the state-owned Botswana Vaccine Institute (BVI), that has been manufacturing & supplying critical veterinary vaccines since the 1970s, in the region and beyond. This project involves setting up a new blending and filling block for veterinary vaccines which would be compliant with cGMP requirements alongside other stringent global standards and guidelines. This initiative aims to enhance the capacity, number of products, quality, efficacy, and safety of the products while ensuring that all regulatory approvals are secured, thus enabling BVI to offer more products that are required in the region and explore new markets. The project commenced in 2022 and is expected to be completed and operational by 2026.   ]]> <![CDATA[Setting Bigger Targets for Next-gen Vaccines]]> https://biospectrumindia.com/features/95/24825/setting-bigger-targets-for-next-gen-vaccines.html https://biospectrumindia.com/features/95/24825/setting-bigger-targets-for-next-gen-vaccines.html Sun, 30 Jun 2024 00:00:00 +0530 The National Institute for Allergy and Infectious Diseases (NIAID), one of the 27 institutes and centres that make up the National Institutes of Health (NIH) of the US, referred to next-generation vaccines as those with enhanced breadth of protection to variants, improved durability, and enhanced ability to block infection/transmission relative to currently approved vaccines. The Coalition for Epidemic Preparedness Innovations (CEPI), a global partnership working to accelerate the development of vaccines and other biologic countermeasures against epidemic and pandemic, describes vaccine technology platforms as technologies that are essential for rapid responses to emerging viral threats.  Essentially, vaccine platform technologies are systems that use the same basic components as a backbone but can be adapted for use against different pathogens by inserting new genetic or protein sequences. Rational vaccine design, developed using suitable vaccine technology platforms, could thus present significant advantages in immunisation. Creating such an unprecedented disease agnostic vaccine technology platform can empower the world to be ready for future pandemics. Studies have shown that next-generation vaccines can enable a higher spectrum of protection against multiple variants, increased durability, and minimal safety concerns due to side effects while increasing their immunogenicity.  Each vaccine’s utility or efficiency is determined by its formulation, adjuvants, and mode of action. The efficacy of the vaccination depends on numeral properties like the generation of antibodies, memory cells, and cell-mediated immunity. Studies on COVID-19 immunisation have shown that next-generation vaccines hold promise in generating long-lasting, broad immunity against virus variants. Since the launch of the first COVID-19 mRNA vaccine, continuous developments in improving mRNA vaccine technology for the SARS-COV2 virus are underway all over the globe. Research approaches from reverse vaccinology and immunoinformatics to continuous-replicating mRNA carrying the antigen of interest are being used to develop new vaccine platforms and improve the current lot of next-generation vaccines. For the larger goal of enhanced immunogenicity, researchers are exploring new antigenic epitopes, the role of immune cell subtypes, and unique adjuvant or delivery vehicles to generate better immune responses.  Approaches such as exploiting the role of mRNA modifications in attuning their immunogenicity, stability, and translational efficiency are important examples. Research into mRNA modifications has yielded multiple candidate mRNA therapeutics undergoing clinical or preclinical trials, as well as effective SARS-CoV vaccines. The COVID-19 mRNA vaccine highlights that using structurally modified mRNA allows for increased dose tolerance and may be better for eliciting a rapid antibody response. The new mRNA COVID-19 vaccine of Moderna, mRNA-1283, designed for multiple SARS-CoV-2 strains found to offer improved neutralising antibody response in individuals more than 65 years of age.  A team from the Yong Loo Lin School of Medicine at the National University of Singapore and Monash University, Australia has engineered a COVID-19 vaccine using a novel vaccine platform to fuse the receptor binding domain of the spike protein of the SARS-COV-2 virus to Clec9A antibody (an antibody against the receptor on dendritic cells presenting antigen to T and B cells to generate immune response). This construct showed long-lasting immunity till 21 months in a preclinical study after only a single dose. This would be a promising approach against waning immunity and a useful strategy for adults above 60 years by eliminating the need for repeated boosting.  The platform of the vaccine, number of doses for immunisation, the production capacity, and vaccine storage condition are all important for the rapid development of the vaccine from laboratory to clinical trials and approval. In addition, vaccine designs that can reduce safety concerns hold the advantage of crossing regulatory hurdles and approval stages in a reasonably short period. Moreover, a focus on next-generation vaccines and novel delivery methods, such as intranasal vaccines, may exhibit more effective and user-friendly vaccination strategies. This can prove crucial in India, owing to factors like the emergence of tropical infections, an overall vaccine hesitancy, a large population to vaccinate, and enabling wide-spread accessibility of vaccines, especially in rural areas.  Fostering an ecosystem for R&D in vaccinology could aid in directing focus toward vaccine discovery, vaccine design, and formulation, as well as vaccine administration methods. Experts across different verticals in this field are now making efforts to build an infrastructure to deliver effective but economical vaccines. This could help to achieve a better sense of preparedness for emerging diseases as well as an all-round improvement of the health impact of vaccines, particularly in the cases of HIV, dengue, malaria, and tuberculosis, which have been outsmarting scientists for decades. In addition, some at-risk groups show even low responses to the vaccines or the existing vaccine have severe side effects and need further development of suitable or more immunogenic vaccines (e.g., for elderly individuals or infants). Given this scenario, enhancing efforts in the development of next-generation vaccines can hold a promise in protection against emerging and re-emerging infections.   Next-gen vaccines in India  Nucleic acid vaccines, viral vector-backbone-based vaccines, and protein subunit vaccines are vaccine platforms being explored for new-generation vaccine developments in many countries. The advent of the COVID-19 pandemic brought the mRNA technology to the forefront. Beyond Pfizer and Moderna, who were pioneering leaders in bringing mRNA vaccine platform to the community, the indigenously developed ‘GEMCOVAC-19’ vaccine is the only third mRNA vaccine to be approved for COVID-19 in the world, and is the very first mRNA vaccine developed in India in June 2023. Developed by Pune-based Gennova Biopharmaceuticals in collaboration with Department of Biotechnology (DBT), this Omicron-specific mRNA (booster) vaccine ‘GEMCOVAC-OM’ is thermostable, which does not require ultra-cold chain infrastructure used for other approved mRNA-based vaccines, making it easy for deployment pan India. It is delivered intradermally using a needle-free injection device system.  Upon Drug Control General of India (DCGI) approval for ‘GEMCOVAC-OM’ for Emergency Use Authorisation (EUA), in June 2023, Dr Jitendra Singh, Union Minister (Independent Charge), Ministry of Science and Technology, commended the efforts of the DBT said, “I take great pride in DBT fulfilling its mission yet again,  enabling technology-driven entrepreneurship through creating this indigenous mRNA-platform technology. We have always supported technology-driven innovation towards the creation of a 'future-ready' technology platform in line with the Prime Minister’s vision of Aatmanirbharta.” He added, "Infrastructure to deploy vaccines in India, including LMICs, at 2-8°C exists today & this innovation is tailored for the existing established supply-chain infrastructure. The vaccine does not need ultra-low temperature conditions for transport and storage."  Dr Rajesh S Gokhale, Secretary, DBT, and Chairperson, Biotechnology Industry Research Assistance Council (BIRAC) said “Strategic infusion of funds is essential to drive and create an ecosystem for technological innovation. DBT did just that when it provided support for the development of the nation’s first mRNA-based platform technology in 2021-22 and development of GEMCOVAC-19’ vaccine. This is a disease-agnostic platform and can be used to make other vaccines in a relatively short developmental timeline.”  Researchers at IIT-Delhi, led by Dr Jayanta Bhattacharya at the institute’s Centre for Biomedical Engineering, developed a novel nanovesicle presenting spike protein on the surface of the dendritic cell-derived extracellular vesicles (DEVs) for use as a potential vaccine platform against SARS-CoV-2. Their research explored an approach to establish the immunogenic nature of DEVs and could demonstrate that a low dose of DEVs induces antibodies to inhibit SARS-CoV-2 infection in vitro. This warrants that with this approach, IIT Delhi researchers effectively developed a COVID-19 vaccine prototype using the body’s own immune cells.  iNCOVACC, Bharat Biotech’s intranasal vaccine for COVID-19, was designed and developed on a novel adenovirus vector. The vaccine demonstrated stimulation of a broad immune response and has the advantage of being non-invasive and needle-free with high compliance. Additionally, the vaccine design and development protocol allows for scalable manufacturing, to even meet global demand. The DCGI under the Central Drug Standards Control Organisation (CDSCO) has granted permission for the sale or distribution of iNCOVACC for immunisation against SARS-CoV-2 virus infection for the age group ≥18 years, for restricted use in emergency situations in public interest. The iNCOVACC vaccine is perhaps an all-round example of a rational vaccine design on a new-generation vaccine technology platform with intranasal delivery as compared to injections.  Zydus Cadila's ZyCoV-D, the world’s first and India’s indigenously developed DNA-based vaccine for COVID-19 is another significant milestone. It was developed by Zydus Cadila in partnership with the DBT, and implemented by BIRAC under the Mission COVID Suraksha. The vaccine received approval for EUA from the DCGI in August 2021, just over a year since the COVID-19 pandemic hit India. The plug-and-play technology on which the plasmid DNA platform is based can be easily adapted to deal with mutations in the virus, such as those already occurring. In addition, studies have shown, including Zydus’s own analysis, that DNA vaccines are stable at higher temperatures, making storage and distribution easier.  A tetravalent dengue subunit vaccine, DSV4, developed by the International Centre for Genetic Engineering and Biotechnology (ICGEB) is a single-component, non-replicating ‘4-in-1′ vaccine based on a virus-like particle (VLP) platform, produced using the methylotrophic yeast Pichia pastoris. In 2016, ICGEB  transferred the dengue vaccine technology licence to Sun Pharma for further development.  Process scale-up has been conducted in the Sun Pharma affiliated biotech company in Germany in 2019, and has been brought back to India for in-house development under the National Biopharma Mission, Government of India. A GMP facility of Sun Pharma is being established in Bangalore and efforts are being made to reach Phase 1 efficacy trials.    What does the future hold? While India is a global leader in manufacturing vaccines, vaccine research, especially the development of next-generation vaccine technologies, are thus far relatively unexplored waters. Having an infrastructure for enabling rapid production of economical and safer vaccines in shorter time frames will allow our public health system to stay poised to fend off emerging diseases. Conventional vaccine development approaches have primarily involved live attenuated or inactivated whole pathogens. These approaches followed largely empirical design and developmental cycles. Additionally, attempts for R & D of traditional platforms of vaccines can take up to several years, which will fail to align with the expectations for fast response and control of epidemics and pandemics of an emerging or re-emerging pathogen.  Indian companies have entered into collaborations with global pharmaceutical firms and research institutions to leverage advanced technologies and expertise. The government is funding and providing regulatory support through DBT and the Indian Council of Medical Research (ICMR). While next-generation vaccines can have their advantages, several major vaccine candidates that have evolved in India are based on traditional live attenuated and inactivated whole organism-derived approaches. These have proven to be immensely successful models for India, as chronicles of vaccines like MMR, OPV, and BCG, among others, have demonstrated for decades.  COVID-19  has resulted in an innovation surge in vaccine development globally and in India. While traditional vaccine development and delivery platforms have proven to be a successful model for India for many decades, it stands to reason that with pathogens evolving to adapt, it will be crucial for humans to evolve vaccine strategies to stay on top.   Shivani Thakar shivani.thakar@biospectrumindia.com   ]]> <![CDATA[European Medicines Agency approves Biocon Biologics' new mAbs facility in India]]> https://biospectrumindia.com/news/95/24813/european-medicines-agency-approves-biocon-biologics-new-mabs-facility-in-india.html https://biospectrumindia.com/news/95/24813/european-medicines-agency-approves-biocon-biologics-new-mabs-facility-in-india.html Mon, 24 Jun 2024 00:00:00 +0530 Biocon Biologics Ltd (BBL), a global, fully integrated biosimilars company and a subsidiary of Biocon Ltd, has received approval from the European Medicines Agency (EMA) to manufacture biosimilar Bevacizumab at its new, world-class, multi-product monoclonal antibodies (mAbs) drug substance facility at Bengaluru. This approval will provide significant additional capacity to address patients' needs across markets in Europe. The facility has previously been approved to manufacture biosimilar Trastuzumab in September 2022. The company has also announced that EMA has renewed its Good Manufacturing Practice (GMP) Certificates of Compliance for its biosimilars manufacturing facility at Bengaluru and its insulin facility in Malaysia following routine GMP inspections. These certificates were issued by the Health Products Regulatory Authority (HPRA), Ireland, on behalf of EMA. ]]> <![CDATA[Plasmagen Biosciences taps into niche Indian biopharma market with launch of CSL’s Haemocomplettan P]]> https://biospectrumindia.com/news/95/24801/plasmagen-biosciences-taps-into-niche-indian-biopharma-market-with-launch-of-csls-haemocomplettan-p.html https://biospectrumindia.com/news/95/24801/plasmagen-biosciences-taps-into-niche-indian-biopharma-market-with-launch-of-csls-haemocomplettan-p.html Thu, 20 Jun 2024 00:00:00 +0530 Plasmagen Biosciences, headquartered in Bengaluru, specialising exclusively in Plasma Protein and Speciality Care Therapy, has recently announced the launch of Haemocomplettan® P (Human Fibrinogen Concenrate), manufactured by CSL Behring, a business unit of global biotechnology leader CSL. Plasmagen is CSL Behring’s exclusive distributor of Haemocomplettan® P in India. Haemocomplettan® P is approved for therapy and prophylaxis of haemorrhagic diatheses in congenital aﬁbrinogenaemia and acquired hypoﬁbrinogenaemia. Due to the high burden of uncontrolled massive bleeding in cardiac and liver transplant surgeries, there is an immense need for a product like Haemocomplettan® P in India. Therefore, Plasmagen pursues a vision of ushering in these niche therapy segments with products like haemocomplettan® P. With approximately 1,50,000 cardiac surgeries and around 1,800 liver transplants being performed in India every year, there is a huge need for such therapies in the country. Approximately 1 out of every 2 cardiac surgery patients requires blood transfusion to manage haemorrhage, and over 25% of blood transfusions in hospitals are for liver transplant recipients and Haemocomplettan® P could be used specially for massive haemorrhagic cases.   ]]> <![CDATA[FOGSI & MSD Pharma release comprehensive immunisation schedule for adult women in India]]> https://biospectrumindia.com/news/95/24758/fogsi-msd-pharma-release-comprehensive-immunisation-schedule-for-adult-women-in-india.html https://biospectrumindia.com/news/95/24758/fogsi-msd-pharma-release-comprehensive-immunisation-schedule-for-adult-women-in-india.html Wed, 12 Jun 2024 00:00:00 +0530 The Federation of Obstetric and Gynaecological Societies of India (FOGSI) has unveiled a comprehensive immunisation schedule for women that provides a comprehensive list of essential vaccines that adult women should receive, and the recommended frequency of each vaccine. FOGSI and MSD Pharma have collaborated to raise awareness about women’s immunisation and help prevent vaccine-preventable diseases in women across India.   A report highlights that women spend 25% more time in poor health compared to men. Vaccination can help change this and safeguard women from vaccine-preventable diseases, contributing to an improved quality of life. Dr Jaydeep Tank, President, FOGSI said, “The launch of FOGSI’s updated immunisation schedule for women represents a significant milestone in the preventive health for women. This comprehensive resource will provide a clear actionable roadmap to both women and doctors resulting into an increased awareness about vaccination."  Rehan A. Khan, Managing Director of MSD India Region said, “Managing one’s health can be challenging without proper information, but with tools such as the immunisation calendar, it can be made simpler. We urge all women to consult their healthcare professional to understand the steps they can take to better protect themselves."    ]]> <![CDATA[Projected Boom Phase of Livestock Vaccines?]]> https://biospectrumindia.com/features/95/24675/projected-boom-phase-of-livestock-vaccines.html https://biospectrumindia.com/features/95/24675/projected-boom-phase-of-livestock-vaccines.html Fri, 31 May 2024 00:00:00 +0530 In India, leading companies such as Indian Immunologicals Limited (IIL), Hester Biosciences, and Biovet are at the forefront of this crucial work. They are collaborating with premier research and academic institutions not only in India but also in countries like the USA, UK, and Australia to develop new vaccine entities to combat complex diseases. Besides there are other animal vaccine companies such as Zoetis, Inc., Elanco India Private Limited, Merck Limited, Ceva Animal Health India Pvt Ltd, Biomed Healthcare, Globion India Private Limited, Biovet Pvt Limited, Brilliant Bio Pharma Pvt Ltd, Indovax Private Limited etc. which are providing the best solutions to the Indian livestock industry.  These efforts extend to partnerships with global companies to develop vaccines tailored for various domesticated animals, including pets, cattle, pigs, goats, and sheep. This collaborative approach ensures that India remains a pivotal player in the global fight against animal diseases, continuously working to improve animal health and safeguard livestock, which is essential for the country's economy and food security. According to Dr K Anand Kumar, Managing Director of Indian Immunologicals Ltd (IIL), the demand for animal vaccines in the country is huge and IIL is standing in the forefront to meet this demand. In fact, IIL stands as the market leader in veterinary and human biologicals in India, producing over 150 vaccine products and hugely catering to the National Animal and Human Health Immunisation programme. “At present our goal is to enhance the quality of livestock in the country, but at the same time we also want to utilise our technological capabilities for the benefit of the people. Keeping this in mind, IIL operates one of the largest veterinary vaccine manufacturing plants globally and possesses robust infrastructure and cold chain distribution capabilities, allowing us to effectively reach both domestic and international markets,” says Anand Kumar.    A few highlights of some of vaccine manufacturing companies that are majorly catering to the animal healthcare needs are as follows: Indian Immunologicals Limited Currently, IIL is a significant player in the animal health market by offering a variety of therapeutic products for livestock and companion animals to enhance their productive and reproductive status along with prophylaxis against certain diseases. The product portfolio comprises vaccines, formulations and nutraceuticals. Additionally, it also markets generics and over-the-counter (OTC) products that are available at veterinary retail stores across India. In 2022, IIL announced expansion of operations in New Zealand through its subsidiary Pristine Biologicals NZ. During the same year it announced that it will invest about Rs 700 crore to set up a new animal vaccine manufacturing facility in Genome Valley, Hyderabad to meet the vaccine security of the nation against economically important diseases such as Foot and Mouth disease (FMD) and other emerging diseases. The facility will create total employment for around 750 people.  At present IIL is exporting 150 different types of vaccine for both animal and human to more than 50 countries across the globe. It is also notable here to highlight that IIL is the first Indian company which has developed rabies vaccine through tissue culture, and is credited for developing the world's first vaccine for porcine cysticercosis, a tape worm like parasite usually found in pigs. Some of the important animal vaccines that are in pipeline for development at IIL include Marker Vaccine for infectious Bovine Rhinotracheitis and Multicomponent Clostridial Vaccine.  Not just IIL, there are also a host of pharmaceutical and vaccine manufacturing firms like Biovet, Hester and others which are equally catching up to cater to the demands of the animal vaccine segment in India.    Biovet  For instance, Biovet, which is a subsidiary of Bharat Biotech, has invested Rs 200 crore for establishing First Biosafety Level-3 PlusAg Vaccine manufacturing facility at Malur in Karnataka. The company is expanding and upgrading its existing infrastructure to manufacture Foot and Mouth Disease (FMD) in animals. The company has successfully manufactured BioFMD-Oil Vaccine to cure and prevent various clinical signs like fever, profuse salivation, Nasal discharge, Vesicle on tongue, lip, and dental pad in cattle, sheep, goat and pigs.  In addition to FMD vaccine, the company is also manufacturing other vaccines like Bluetongue Disease Vaccine, Haemorrhagic Septicaemia Disease Vaccine, Johne's disease Vaccine and Black Quarter Disease Vaccine etc, which are all catering to prevent and cure various diseases in Animals.  Highlighting about the company’s facilities, Narayan Singh, Managing Director of Biovet Pvt Ltd observed that the company is a leader in FMD vaccine production and it has established a world class facility at the Malur in Karnataka.  “We have invested Rs 150 crore for setting up a world class facility for manufacturing FMD vaccine. At Biovet our R&D division is engaged in the development of products and processes, and in transferring the technologies to the production section. The focus is on inventing and developing vaccines for new infectious, emerging and reemerging diseases of animals at economical and affordable prices,” says Singh.  From a one-product company, Biovet is now growing to a multi-product company because of its in-house R&D and process development. Biovet in collaboration with national and international organisations is bringing in the latest concepts and methods in product development.  For ensuring biosafety, the company has set up India’s 1st and World’s 2nd BSL-3 + Ag Production Animal Facility, this Global Standard Facility was set up with an investment of Rs 150 crore. It is also a BSL-3 + Ag Large Animal Testing Facility located at Bengaluru, in Karnataka.    Hester Biosciences Another  major animal vaccine manufacturer in India, Hester Biosciences provides preventive medicines to various categories of animals. The company  was founded by Rajiv Gandhi, CEO and Managing Director in 1997. The company which had started by releasing a single vaccine then has today grown into Asia’s largest vaccine producers, exporting various animal vaccine products to different countries globally.   The company’s product portfolio includes Inactivated Vaccines, Live Vaccines, and animal and poultry healthcare products. Hester has recorded considerable growth by contributing to the National Animal Immunisation programme in India.  Recently, all states in India have initiated an immunisation programme targeting Lumpy Skin Disease through the Goat Pox Vaccine; this has helped the country gain good profits. However, the company had faced some hurdles in the exports of animal vaccines to international markets due to a decline in demand.  Apart from catering to vaccines for  cattle, sheep, goat and pet animals, Hester Biosciences is also contributing heavily for the poultry sector. Apart from catering the animal vaccine needs of India, Hester has also established its unit in Africa and began production in 2021 and meeting the unmet demand of the African animal sector.  “In addition to catering to the domestic demand in India, we are also exporting our animal vaccines to various countries where there is a huge demand. Particularly, Africa, as a continent, is still an untapped market for immunisation of animals against diseases. Africa has a huge gap in demand and supply as there are only a few animal vaccine manufacturers in the entire continent. Tanzania has the third-largest herd of domestic livestock in the world. We not only see this as a wonderful opportunity for growth, but also as a way to promote better health for human beings through healthier animals,” said Rajiv Gandhi, CEO and Managing Director, Hester Biosciences. Today, Hester Biosciences has emerged as one of India’s leading animal healthcare companies and is the second largest poultry vaccine manufacturer in the country.   Growing Burden of Livestock Diseases  The India animal health market size reached Rs 80 billion in 2023. Looking forward, IMARC Group expects the market to reach Rs 160.5 billion by 2032, exhibiting a CAGR of 7.8 per cent during 2024-2032. The growing occurrences of zoonotic diseases, the increasing investment by the government authorities to enhance animal healthcare, and extensive research and development (R&D) activities conducted by key players are some of the major factors propelling the market. Diverse segments contribute to India's animal healthcare market, with livestock comprising 51 per cent, poultry 35 per cent, companion animals 8 per cent, aquaculture 5 per cent, and other animals 1 per cent. Key vaccines, such as those targeting Peste des petits ruminants (PPR), Brucellosis, and FMD, are in high demand, reflecting the nation's commitment to combating prevalent animal diseases and ensuring food security. The sector's expansion is fueled by increasing demand for animal-derived products, including eggs, dairy, and meat, alongside a growing affinity for companion animals. As the prevalence of animal diseases rises, so does the imperative for robust vaccination programmes, positioning India for sustained growth in this domain. A proactive governmental stance, epitomised by initiatives like the 'National Animal Disease Control Programme,' further amplifies opportunities for growth in the animal healthcare sector. Through strategic investments and collaborative efforts, India is poised to not only meet domestic demand but also emerge as a prominent player in the global arena of animal vaccination, shaping the future of veterinary healthcare on a worldwide scale.   Indian Animal Vaccine Industry Growth  The Animal Vaccine Industry in India is experiencing significant growth, driven by various factors such as the rising prevalence of zoonotic diseases, growth in the livestock population, increasing demand for animal products, a burgeoning pet healthcare market, and growing investment in research and development (R&D) for drug and vaccine development. Under government initiatives like "One Health," there is a concerted effort to tackle health threats through an intersect oral approach, emphasising the interconnectedness of animals, the environment, and human health. Regulatory bodies like the Veterinary Cell of the Central Drugs Standard Control Organisation (CDSCO) and research institutions like the Indian Institute of Veterinary Institute (IVRI) play crucial roles in overseeing and advancing the animal health sector.  The Veterinary Cell of CDSCO is responsible for regulating animal health products in India, ensuring their safety, efficacy, and quality. Technical reviews for product registration of farm and companion animals are conducted by the Department of Animal Husbandry and Dairying, while the Department of Fisheries oversees aqua products. The IVRI is instrumental in researching and evaluating biologicals in the veterinary sector. According to a TechSci Research report, the Indian animal vaccine market stood at $235.52 million in 2023 and is projected to grow at a compound annual growth rate (CAGR) of 5.02 per cent from 2025 to 2029. This robust growth can be attributed to several factors, including the increasing prevalence of animal diseases and heightened awareness about animal health among livestock and pet owners. The rise in various animal diseases is a significant driver for the animal vaccine market in India. Increased awareness among livestock and pet owners about the importance of animal health, coupled with government initiatives promoting veterinary care, are also contributing to market growth. Furthermore, substantial investments in R&D are propelling advancements in biotechnology, leading to the creation of more effective and safer animal vaccines. "In a country like India, where livestock is integral to the economy, animal health is crucial," observed Dr Ravinder Reddy, Vice Chancellor of P V Narasimha Rao Veterinary University in Hyderabad. "Livestock directly impacts the livelihood of millions, particularly in rural areas where agriculture and pastoral activities are the main income sources. Healthy livestock contributes to food security by providing essential products such as milk, meat, and eggs."   Strong Demand & Continuous Innovations  The animal vaccine industry in India stands at the cusp of growth, yet faces several challenges hindering its full potential. Regulatory complexities, inadequate infrastructure, and limited awareness about preventive healthcare among animal owners are among the hurdles. Storage costs and a shortage of skilled personnel further complicate matters, especially in rural areas with unreliable electricity supply. However, amidst these challenges lie opportunities for collaboration and advancement. Initiatives like "One Health" and the National Animal Disease Control Programme offer avenues for cooperation. Strengthening regulatory frameworks, enhancing R&D capabilities, and leveraging technological innovations can pave the way for overcoming obstacles and unleashing the industry's full potential. Technological advancements, notably in artificial intelligence and big data analytics, have revolutionised vaccine development. These breakthroughs have accelerated the creation of highly effective vaccines, bolstering disease prevention and control efforts. Despite challenges, the animal vaccine industry in India is set for significant growth. Factors such as rising demand for animal products, increasing pet ownership, and growing awareness about zoonotic diseases are driving this trajectory. With supportive government initiatives and a conducive regulatory environment, India is poised to emerge as a global leader in animal vaccination and pharmaceuticals. In conclusion, sustained investment in R&D and biotechnology will propel the industry forward, offering innovative solutions for animal health. As key players continue to develop effective vaccines, India's role in global animal health will strengthen, benefitting both livestock and human populations alike.   Amguth Raju hyderabad@mmactiv.com ]]> <![CDATA[Emcure and Gennova to resume mRNA collaboration with HDT]]> https://biospectrumindia.com/news/95/24659/emcure-and-gennova-to-resume-mrna-collaboration-with-hdt.html https://biospectrumindia.com/news/95/24659/emcure-and-gennova-to-resume-mrna-collaboration-with-hdt.html Thu, 23 May 2024 00:00:00 +0530 Mumbai-based Emcure Pharmaceuticals and its biotech subsidiary, Gennova Biopharmaceuticals have amicably resolved all legal disputes with US-based HDT Bio Corp.  According to media reports, a lawsuit was filed by HDT against Emcure accusing it of stealing trade secrets from biopharma company HDT Bio to develop a COVID-19 vaccine. The litigation between them, including before US courts and the arbitral tribunal in London, has been settled and dismissed. Gennova and HDT, who previously collaborated on the successful development of Gennova’s mRNA COVID-19 vaccines will once again collaborate on the development and commercialisation of mRNA vaccines. The parties have entered into a long-term agreement to develop mRNA vaccines against a broad range of infectious diseases, in India and several other countries. As part of their agreement, HDT has granted a license to Gennova to use HDT’s patented mRNA vaccine technology in multiple fields.  “Emcure is delighted that the misunderstanding between us and HDT not only stands resolved but we have widened the scope of our technical collaboration on a long term basis. mRNA platform will be the launching pad for our foray into vaccines for tuberculosis, rabies, dengue and other infectious diseases and our collaboration with HDT will be mutually beneficial,” observed Satish Mehta, CEO & Managing Director of Emcure.  Dr Steve Reed, CEO of HDT, echoed Mehta’s sentiments and added that “HDT’s proprietary technology, combined with Emcure’s & Gennova’s innovation and manufacturing excellence and established distribution network will bring life-saving vaccines to countless people. We are committed to a successful relationship with Emcure and Gennova.”    ]]> <![CDATA[Biocon enters US ophthalmology market with US FDA approval of Yesafili]]> https://biospectrumindia.com/news/95/24647/biocon-enters-us-ophthalmology-market-with-us-fda-approval-of-yesafili.html https://biospectrumindia.com/news/95/24647/biocon-enters-us-ophthalmology-market-with-us-fda-approval-of-yesafili.html Tue, 21 May 2024 00:00:00 +0530 US Food and Drug Administration (US FDA) has approved Bengaluru-based Biocon Biologics' first-to-file application for Yesafili (aflibercept-jbvf), an interchangeable biosimilar aflibercept. Yesafili, a vascular endothelial growth factor (VEGF) inhibitor used to treat several different types of ophthalmology conditions, is a biosimilar of its reference product EYLEA (aflibercept). Yesafili is intended for the treatment of neovascular (wet AMD) age-related macular degeneration, visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO), visual impairment due to diabetic macular oedema (DME) and visual impairment due to myopic choroidal neovascularisation (myopic CNV). It is highly similar to the reference product Eylea (aflibercept). Data shows that Yesafili has comparable quality, safety, and efficacy to Eylea. The approval marks Biocon Biologics’ expansion into the ophthalmology therapeutic area in the United States following a steady track record of approval in Europe (September 2023) and the United Kingdom (November 2023) where it was the first biosimilar aflibercept to be approved. The company has secured a launch date in Canada of no later than July 1, 2025, under the terms of a settlement agreement. Shreehas Tambe, CEO & Managing Director, Biocon Biologics said: "The FDA approval of Yesafili (aflibercept) as the first interchangeable biological product to Eylea is a significant milestone for Biocon Biologics marking our entry into Ophthalmology, a new therapeutic area in the United States. Yesafili is approved for the treatment of neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema and diabetic retinopathy. This approval builds on our successful track record of bringing the first interchangeable insulin, SEMGLEE, the first biosimilar Trastuzumab, OGIVRI, and the first biosimilar Pegfilgrastim, FULPHILA, to patients in the United States."   ]]> <![CDATA[Serum Institute of India ships first set of R21/Matrix-M malaria vaccine doses to Africa]]> https://biospectrumindia.com/news/95/24639/serum-institute-of-india-ships-first-set-of-r21-matrix-m-malaria-vaccine-doses-to-africa.html https://biospectrumindia.com/news/95/24639/serum-institute-of-india-ships-first-set-of-r21-matrix-m-malaria-vaccine-doses-to-africa.html Mon, 20 May 2024 00:00:00 +0530 Serum Institute of India, the world’s largest manufacturer of vaccines by number of doses, marks a significant milestone with the shipment of its first set of R21/Matrix-M malaria vaccine to Africa.  The initial shipment will be sent to the Central African Republic (CAR), followed by other African countries such as South Sudan and Democratic Republic of Congo in the next coming days. In total, 1,63,800 doses of the R21/Matrix-M malaria vaccine have been specifically allocated for CAR region, out of which only 43,200 doses have been dispatched today from Serum Institute of India’s facility. Developed in collaboration with the University of Oxford and Novavax’s Matrix-M adjuvant, the R21/Matrix-M vaccine is the second malaria vaccine to be authorised for use in children in malaria-endemic regions. The flag-off ceremony of the R21/Matrix-M malaria vaccine took place at Serum Institute of India's facility in Pune. The R21/Matrix-M malaria vaccine, developed through collaboration between the Jenner Institute at Oxford University and the Serum Institute of India leveraging by Novavax’s saponin-based adjuvant technology, received support from the European and Developing Countries Clinical Trials Partnership (EDCTP), the Wellcome Trust, and the European Investment Bank (EIB). Till date, Serum Institute of India has manufactured 25 million doses with a capacity to scale up to 100 million doses annually.   Image caption- L-R- Natasha Poonawalla - Executive Director, Serum Institute of India, Chairperson, Villoo Poonawalla Foundation; Adar Poonawalla - CEO, Serum Institute of India and Eric Garcetti, US Ambassador to India with  R21/Matrix-M malaria vaccine ]]> <![CDATA[Serum Institute of India invests in needle-free injection system technology]]> https://biospectrumindia.com/news/95/24635/serum-institute-of-india-invests-in-needle-free-injection-system-technology.html https://biospectrumindia.com/news/95/24635/serum-institute-of-india-invests-in-needle-free-injection-system-technology.html Fri, 17 May 2024 00:00:00 +0530 Serum Institute of India (SII) has announced a strategic investment in Pune-based startup IntegriMedical, acquiring a 20% stake in the company, to advance Needle-Free Injection System technology. The partnership between SII and IntegriMedical aligns with SII's vision of 'Health for All' and IntegriMedical's mission to ‘Transform Healthcare Globally’ by providing patient comfort, ensuring increased patient compliance, reducing needle-stick injuries, and enhancing the efficacy of liquid medication via needle-free dispersion. IntegriMedical has developed a US patented Needle-Free Injection System (N-FIS) that utilises high-velocity jet stream using mechanical power to effectively and consistently administer biologics and drugs. The innovative drug delivery solution aims to alleviate pain during administration, providing needle-phobic patients with a pleasant and stress-free experience. Commenting on the strategic investment, Adar Poonawalla, CEO, Serum Institute of India, shared, “IntegriMedical's Needle-Free Injection Systems (N-FIS) represent a significant advancement in drug delivery and we envision a needle-free solution to deliver vaccines." IntegriMedical’s Needle-Free Injections System also known as N-FIS has received regulatory approvals from CDSCO, CE, MDSAP and is ISO 13485 certified.  N-FIS will be available in the Indian private market, offering patients and healthcare providers an alternative to traditional needle-based injections. The technology's advantages include the elimination of needle-phobia, alleviation of pain during administration, convenience of use, and prevention of needle-stick injuries and cross-contamination. ]]> <![CDATA[ABLE inks MoU with Emerging Biopharmaceutical Manufacturers Network ]]> https://biospectrumindia.com/news/95/24601/able-inks-mou-with-emerging-biopharmaceutical-manufacturers-network-.html https://biospectrumindia.com/news/95/24601/able-inks-mou-with-emerging-biopharmaceutical-manufacturers-network-.html Wed, 08 May 2024 00:00:00 +0530 Association of Biotechnology Led Enterprises (ABLE) has announced the signing of a Memorandum of Understanding (MoU) with Emerging Biopharmaceutical Manufacturers Network (EBPMN) to promote cross-border innovation, investment, and technological exchange in India and low and middle-income countries. The understanding is expected to benefit ABLE & EBPMN member biopharma companies in expanding their businesses with introductions to potential business partners, clients, etc. The MoU will (1) foster promotion technology and technology-based investment and business expansion in India and low and middle-income countries, (2) enhance the global access of biopharmaceuticals by facilitating local manufacturing capacity in India and low and middle-income countries, and (3) supporting collaborative research and development in areas of common interest between members of the two organisations.   ]]> <![CDATA[Serum Institute of India partners with ImmunityBio for global supply of BCG across all cancer types]]> https://biospectrumindia.com/news/95/24579/serum-institute-of-india-partners-with-immunitybio-for-global-supply-of-bcg-across-all-cancer-types.html https://biospectrumindia.com/news/95/24579/serum-institute-of-india-partners-with-immunitybio-for-global-supply-of-bcg-across-all-cancer-types.html Fri, 03 May 2024 00:00:00 +0530 US-based ImmunityBio, Inc. has signed an exclusive global arrangement with the Serum Institute of India (SII), to supply ImmunityBio with Bacillus Calmette-Guerin (BCG). The agreement covers the manufacturing of standard BCG (sBCG) that is currently approved for use outside the US, as well as a next-generation recombinant BCG (iBCG) undergoing testing, intended for use in combination with ImmunityBio’s ANKTIVA for currently approved and potential future indications, subject to regulatory approvals. The arrangement will result in additional supplies of the current standard sBCG immediately for trials. At the same time, the two companies will work to accelerate the ongoing Phase 2 clinical trials of iBCG currently being conducted in Europe which has so far demonstrated safety advantageous over standard BCG as well as enhanced immunogenicity in driving both CD8+ and CD4 T cells. The collaboration between SII and ImmunityBio comes on the heels of the FDA’s approval of ANKTIVA for the treatment of non-muscle invasive bladder cancer with carcinoma in situ (CIS). Increasing the available supply of BCG is intended to address shortages for the combination therapy with ANKTIVA. Originally used as a tuberculosis vaccine, BCG administered via intravesical instillation (delivery to the bladder via a catheter) has been the standard of care for patients with non-muscle invasive bladder cancer since 1977. BCG is a benign bacterium that induces an immune response in the bladder in proximity to the cancer cells, leading to clearance of the cancer in many patients. ]]> <![CDATA[India Ramps Up HPV Vax Efforts ]]> https://biospectrumindia.com/features/95/24558/india-ramps-up-hpv-vax-efforts-.html https://biospectrumindia.com/features/95/24558/india-ramps-up-hpv-vax-efforts-.html Wed, 01 May 2024 00:00:00 +0530 As characterised and defined by the World Health Organisation (WHO), Human papillomavirus (HPV) is a common sexually transmitted infection that can affect the skin, genital area, and throat. Almost all cervical cancer cases (99 per cent) are linked to infection with high-risk HPV, an extremely common virus transmitted through sexual contact. Although most infections with HPV resolve spontaneously and cause no symptoms, persistent infection can cause cervical cancer in women. Furthermore, experts worldwide gauge that typically, it takes 15–20 years for abnormal cells to become cancer, but in women with weakened immune systems, such as untreated HIV, this process can be faster and take 5–10 years. Risk factors for cancer progression include the grade of oncogenicity of the HPV type, immune status, the presence of other sexually transmitted infections, number of births, young age at first pregnancy, hormonal contraceptive use, and smoking.  According to WHO guidelines for the initiative of elimination of cervical cancer, all countries should reach and maintain an incidence rate of below 4 per 100,000 women. Achieving that goal rests on three key pillars and their corresponding targets: vaccination: 90  per cent  of girls fully vaccinated with the HPV vaccine by the age of 15; screening: 70  per cent  of women screened using a high-performance test by the age of 35, and again by the age of 45 and treatment: 90  per cent  of women with pre-cancer treated and 90  per cent  of women with invasive cancer managed. Only 1  per cent  of women are screened for cervical cancer in India, as per a recent report. The rate of HPV vaccination in the country is suboptimal at present, due to several factors.  With the Indian government announcing the inclusion of the HPV vaccine in the national immunisation programme and the breakthrough development by Serum Institute of India (SII) in manufacturing India’s own HPV vaccine ‘Cervavac’, India can boost its efforts in achieving this 90-70-90 target and thereby blaze a brighter path for cervical cancer elimination.  As a priority, HPV vaccines should be given to all girls aged 9–14 years, before they become sexually active. The vaccine may be given as 1 or 2 doses. People with reduced immune systems should ideally receive 2 or 3 doses. Some countries have also chosen to vaccinate boys to further reduce the prevalence of HPV in the community and to prevent cancers in men caused by HPV.    Reducing healthcare burden  Vaccination is considered a cost-effective preventive measure compared to treating established cancers, saving healthcare systems significant resources.  The costs of cervical cancer treatment and management can vary significantly, influenced by factors such as the stage of cancer, geographical location, and healthcare infrastructure. Experts say that the treatment options for cervical cancer in India primarily include surgery, radiotherapy, chemotherapy, and palliative care, in addition to newly added technologically advanced treatment options. Screening leads to a reduction in the occurrence of cervical cancer cases with a decrease in cancer deaths, and the Visual Inspection with Acetic acid (VIA) every 5 years is the most cost-effective screening method in the context of India. Preventive intervention by HPV vaccination, especially at the right age, can contribute to reducing disease severity.    A 2020 study published in Lancet Oncology evaluating the potential survival effect of scaling up treatment showed that the cumulative effect of scaling up all imaging modalities together with expanded treatment and quality of care could improve 5-year net survival for cervical cancer to 62·5  per cent  (globally). Investments in imaging equipment, personnel, and quality of care will be needed to scale up cervical cancer treatment successfully.  Additionally, according to a 2020 PLOS One study assessing the cost-effectiveness of various screening strategies for cervical cancer and HPV vaccination in India, immunising adolescent girls for HPV along with screening women using VIA appears to be a cost-effective strategy at both 5 yearly and 10 yearly frequencies of VIA screening, as compared to no vaccination and no screening. This indicates that successful vaccination may hold grand potential in the economical management of disease burden and this factor will be especially relevant in a country where cervical cancer burden is high. The inclusion of the cervical cancer vaccine in the national immunisation programme is a highly welcome move from the government.      Barriers and challenges   The most significant barriers being gauged by experts in achieving this large-scale vaccination will be the huge population to cover, lack of awareness combined with an overall vaccine hesitancy due to myths regarding vaccine safety, social/religious stigma, and vaccination costs.  Commenting on the cost factor for the vaccine candidates, Dr Smita Joshi, preventive oncologist and programme director at Jehangir Clinical Development Center, Pune, mentions, “Quadrivalent and nine-valent vaccine Gardasil by Merck and Cervavac by SII are the 3 vaccines available in India currently. Cervarix (bivalent HPV vaccine by GSK) has not been available in the Indian market for one year. SII’s HPV vaccine is slightly cheaper than Gardasil for the private market. It is supposed to be given to the government for Rs 300-500 per dose. However, it costs about Rs 1200 -1400 per dose in the private market.” Furthermore, building the optimal infrastructure to execute the required scale and magnitude of HPV vaccination in the country and developing strategies for the sustenance of the vaccination programme are going to be additional key players in overcoming logistical hiccups. Reaching out-of-school girls to complete the vaccine regimens, poor tracking systems, and overall low rate of candidate adherence to vaccine regimen due to multiple doses (two to three doses may be recommended for Cervavac) can pose additional challenges in streamlining and monitoring the vaccination programme performance.  Dr Smita Joshi, preventive oncologist and programme director at Jehangir Clinical Development Center, Pune, stated, “Government will need proper implementation plan, powerful messaging, and communication strategy, ensure sustained funding and continuation of the programme, in addition to baseline political commitment. Monitoring screening and vaccination of out-of-school girls will be an important factor requiring adherence in ensuring maximal coverage for the vaccination drive.” She also added that with the current health infrastructure being overburdened, vertical investment is essential not only for vaccination but also for cervical cancer screening and management of precancers in adult women.  Estimating target populations and validating the availability of the necessary health infrastructure in the various parts of the country are important factors to consider when implementing a nationwide HPV vaccination initiative. Because of this, developing an evidence-based vaccination policy and guidelines for the new Cervavac HPV vaccine may prove crucial.  Reports indicate that in India, a significant proportion of cervical cancer cases come from rural areas. As compared to urban areas, access to facilities like regular screening, testing as well as general awareness regarding sexual health and sexually transmitted infections is considerably lower in India’s rural population. In the absence of these critical factors, covering the rural population optimally in implementing the nationwide vaccination programme might prove significant. In this regard, experts presume that the role of ASHA and Anganwadi workers in boosting HPV vaccination and fostering the right direction towards preventive healthcare (especially in rural areas) may be significant.  Additionally, given that developing evidence-based policies and guidelines will have benefits, consideration of the state-wise distribution of cervical cancer burden may become a significant factor for effective strategising. According to Dr Priya Kapoor, Consultant - Surgical Oncology (Gynaecology), Apollo Proton Cancer Centre Chennai, “More than 5 million women are at risk of developing cervical cancer. The age-adjusted incidence rate of HPV-related cancers is high in areas of Meghalaya and Assam. Delhi is also not far behind.”  Enabling equitable access to all socioeconomic groups to execute maximal vaccine coverage can drive India in the direction of truly reducing the disease burden resulting from HPV infections, which, although majorly includes cervical cancer caused by HPV subtypes 16 & 18, also comprises of conditions like anogenital warts, vaginal cancer, anal cancer, oropharyngeal cancer, etc. All in all, collaborative efforts involving healthcare professionals, policymakers, and the public are crucial in raising awareness about the importance of HPV vaccination. Dispelling misconceptions, promoting accurate information, and ensuring widespread access to vaccination will lead to significant strides in preventing cervical cancer and enhancing women’s health in India.   Cervavac by SII Although Serum Institute of India (SII)’s Cervavac was officially launched in 2022 and has been available in the market in private hospitals for nearly two years now, HPV vaccination has not gained the necessary momentum yet. High cost per dose and a probable limited community-wide reach of the private healthcare sector can be gauged as primary reasons. With the announcement of HPV vaccination to be rolled out for all girls aged 9-14 years and the government also planning to include the HPV vaccine in the national immunisation programme, the picture would change dramatically in the positive direction.  Remarking on the upcoming country-wide vaccination phase, Dr Umesh Shaligram, Executive Director of R&D, Serum Institute of India, said, “The government has a plan in place and a budget ready to begin the roll out for vaccination of girls aged between 9 and 14 years. The government might start the rollout in the third or fourth quarter of 2024. For that, Serum has got the back end covered and is poised to ensure efficient supply for this pilot phase of Cervavac mass vaccination.”   Elaborating on the timeline of upscaling Cervavac production to align with the government’s plans and goals, Dr Shaligram touched upon the role of  COVID-19 on the supply chain logistics for large-scale HPV production, which was originally planned by SII to take off around 2019-2020. The pandemic not only disrupted the supply chain resulting in delayed deliveries of the required equipment from the West but it also raised constraints concerning space and resource allocation, as the need of the hour demanded a high priority to the manufacturing of COVID-19 vaccines. The post-pandemic recovery allowed us to reset the momentum and focus on the HPV vaccine, where SII focussed on building up the necessary infrastructure for Cervavac manufacturing from scratch. “It took almost a couple of years for us to get the infrastructure ready. Production set-up for scale-up of the Cervavac vaccine kickstarted in 2023, and now SII is all set to cater to the needs of the upcoming country-wide HPV vaccination”, added Dr Shaligram.  For the Indian market, available HPV vaccine candidates include the Merck vaccine Gardasil, the GSK vaccine Cervarix, and the indigenous Cervavac vaccine by Serum Institute of India. With some reports citing a potential discontinuation of the Cervarix vaccine from the Indian market, Gradasil and Cervavac would be the available choices in the long run.  Cervavac is very close in design and efficacy to the Merck vaccine, with both quadrivalent vaccines targeting the major HPV subtypes 16 & 18. Cervavac has also demonstrated protection against HPV 6 & 11 subtypes, which cause health conditions other than cervical cancer such as genital warts and cancerous lesions in other organs. In addition to the broad-spectrum efficacy of Cervavac, the advantages it incurs include the cost-effectiveness and the scale of vaccine availability for extended distribution owing to the strategic efficiency and manufacturing prowess of the Serum Institute of India.  According to the data provided by the Central Drugs Standard Control Organisation(CDSCO), the safety profile of Cervavac is based on data from clinical trial (SII-qHPV/IN-02) conducted in India where Cervavac was administered to 1530 study participants aged 9 through 26 years. The most common events occurring after Cervavac administration were injection site pain, and headache. The majority of adverse events were mild to moderate in severity and usually resolved within a few days of vaccination. Adverse events are organised by MedDRA System Organ Class (SOC).    Commenting on the rollout of Cervavac doses, Dr Shaligram added, “Considering the Indian birth cohort, which is up to 25 to 26 million per year, the number of doses recommended per individual and the estimated size of the target population of girls aged between 9 & 14 years, Serum Institute is looking at catching up to approximately 300 million vaccinations overall.” In addition to the cohort of girls aged between 9 & 14 years, the Cervavac vaccine can also be recommended for adolescent boys, as well as older men and women beyond 14 years of age up to 26 years of age. He also added that as vaccine advocacy and awareness improve, the government will shift focus to the older age groups and aim to cover that large cohort as well in the coming few years.  In view of the incorporation of the vaccine's rollout schedule and the government’s plans for implementing the vaccination programme, Dr Shaligram said that although a high demand for Cervavac is certainly expected, the government would look to implement the vaccination programme in phases and open up the country to HPV vaccination in parts. He added that Serum Institute is all set up to meet the increasing demands for Cervavac in India, and after covering the needs of India, Serum Institute will then look to go global with the Cervavac vaccine after some years.    Managing cervical cancer burden The objectives of the National Programme for Prevention and Control of Cancer, Diabetes, Cardiovascular Diseases and Stroke (NPCDCS), being implemented by the Central Government under the National Health Mission (NHM) for interventions up to the district level, include awareness generation for cancer prevention, screening, early detection and referral to an appropriate level institution for treatment, including cervical cancer. Screening of common NCDs including three common cancers i.e. oral, breast, and cervical is also an integral part of service delivery under Ayushman Bharat - Health and Wellness Centres. Experts add that the path ahead to managing the cervical cancer burden also requires sustained collaboration between the government, healthcare organisations, NGOs, and communities to achieve comprehensive cervical cancer prevention. Dr Smita Joshi, preventive oncologist leading the cervical cancer management operations at the NGO ‘Prayas’ in Pune shared, “Prayas has screened over 35,000 women and treated screen-positive women according to the WHO guidelines till date. However, our programme depends upon the donations that we receive. There are very few NGOs working in the field and everyone is doing their own small thing however a coordinated effort will help. However, for programme sustenance, better government policies are necessary.” Under the NCD control plan, the PHCs are supposed to offer cervical cancer screening using VIA (whereas the WHO has suggested an HPV test). Treatment of cancers is also available under the Ayushman Bharat - Pradhan Mantri Jan Arogya Yojana (PMJAY). Under the umbrella scheme of Rashtriya Arogya Nidhi, financial assistance is provided to families living below the threshold poverty line for their treatment, including treatment of cancer, in government hospitals. The ICMR-National Institute of Cancer Prevention and Research (NICPR) has made important strides in cervical cancer prevention. NICPR-ECHO training courses are continuing efficiently to train in-service healthcare providers in cancer screening and for capacity building of pathologists, especially in remote areas. The government is also collaborating with national and international healthcare organisations like WHO and UNICEF for technical assistance in planning, implementing, and monitoring the HPV vaccination programme.  However, it's good to know that a study published in 2022 in ‘BMC Cancer sheds light on the trends in the incidence and mortality of cervical cancer in India and its states between 1990 and 2019. The study is based on the data collected from various sources like the Global Burden of Disease study and the Bombay Cancer Registry and highlights that the incidence and mortality of cervical cancer declined over the past three decades, but also talks about how it is still a major public health problem in India.   Shivani Thakar (shivani.thakar@biospectrumindia.com)   ]]> <![CDATA[Biocon signs agreement with Biomm for generic Semaglutide commercialisation in Brazil]]> https://biospectrumindia.com/news/95/24517/biocon-signs-agreement-with-biomm-for-generic-semaglutide-commercialisation-in-brazil.html https://biospectrumindia.com/news/95/24517/biocon-signs-agreement-with-biomm-for-generic-semaglutide-commercialisation-in-brazil.html Fri, 19 Apr 2024 00:00:00 +0530 Bengaluru-based biopharmaceutical firm Biocon has announced the signing of an exclusive licensing and supply agreement with Biomm S.A., a specialty pharmaceutical company in Brazil, for the commercialisation of its vertically integrated drug product, Semaglutide (gOzempic), which is used to improve glycemic control in adults with type-2 diabetes. Under the terms of this agreement, Biocon will undertake the development, manufacturing and supply of the drug product, and Biomm will be responsible for obtaining regulatory approval and commercialisation in the Brazilian market. Biomm is Brazil’s first and only biotechnology focused company, providing high quality healthcare to patients with chronic conditions and enhancing access to the latest technologies and treatments. The company focuses on developing, manufacturing and commercializing complex biotech and biosimilar drug products at their state-of-the-art production facility in Nova Lima. Siddharth Mittal, Chief Executive Officer and Managing Director, Biocon, said, “Our partnership with Biomm marks another important step forward in our strategy to expand our global footprint beyond the US and Europe for Peptides. This is also in line with our growth strategy of bringing to market a portfolio of complex, GLP-1 drug-device combination products.” Heraldo Marchezini, Chief Executive Officer, Biomm, commented: “Brazil is the fifth country in the world with the highest incidence of diabetes, having 16.8 million adults in the age group of 20 to 79 years with the disease, and an estimated 21.5 million cases by 2030, according to the Diabetes Atlas of the International Diabetes Federation (IDF)." The total addressable market opportunity of Semaglutide in Brazil is approximately $580 million as per the IQVIA MAT Q4 2023 ]]> <![CDATA[Avantor emphasises importance of collaboration, leveraging technological advancements in India Biopharma Forum Series]]> https://biospectrumindia.com/news/95/24512/avantor-emphasises-importance-of-collaboration-leveraging-technological-advancements-in-india-biopharma-forum-series.html https://biospectrumindia.com/news/95/24512/avantor-emphasises-importance-of-collaboration-leveraging-technological-advancements-in-india-biopharma-forum-series.html Tue, 16 Apr 2024 00:00:00 +0530 Avantor, Inc., a leading global provider of mission-critical products and services to customers in the life sciences and advanced technology industries, recently hosted first of its kind series of Biopharma forums across India in Bengaluru, Hyderabad and Pune to emphasise Avantor’s commitment to creating customized solutions for customers by identifying and addressing the challenges faced by biopharma companies in India. The Indian biopharmaceutical industry is rapidly expanding with increased investments in research and development, robust product pipelines, collaborations, and technological advancements. However, challenges such as constantly evolving regulatory compliances and price and quality control impede global competitiveness. The 2024 Avantor Biopharma Forums focused on critical topics including scale-up, risk mitigation, and cost optimisation, which are crucial for addressing these challenges and driving growth in the biopharma industry. With the goal of facilitating an enriching exchange of ideas for professionals within India’s Bioprocessing industry, the forums provided a platform for over 600 participants from some of the prominent biopharma players in India to engage with Avantor's products and solutions, fostering knowledge exchange and collaboration within the bioprocessing community. The highlight of the forums was industry panel discussions with biopharma experts from leading biotechnology and biopharmaceutical companies across the three cities. Ger Brophy, Chairman of Avantor’s Scientific Advisory Board, spoke about the Readiness for Changing Biological Molecules and Regulatory Environment and shared his perspective about the ever-evolving regulatory environment in the country. Highlighting the evolution of the industry, Narayana Rao Rapolu, VP, Biopharma and Applied Products Solutions, said, “The Indian biopharma sector is witnessing a rise with the introduction of high-quality, cost-effective biosimilars into the market." Nandkumar Deorkar, SVP Research and Development, Avantor, shared his insights about the effective management of Total Cost of Ownership in Bioprocessing. “At Avantor, we work to simplify our customers’ scale-up processes thereby eliminating process steps. Avantor’s objective is to create long- term, strategic partnerships within the industry by working closely with biomanufacturers to drive and foster cost optimisation and improve biologics process efficiencies."   ]]> <![CDATA[How Telangana is Targeting Innovation Beyond Generics ]]> https://biospectrumindia.com/features/95/24448/how-telangana-is-targeting-innovation-beyond-generics-.html https://biospectrumindia.com/features/95/24448/how-telangana-is-targeting-innovation-beyond-generics-.html Mon, 01 Apr 2024 00:00:00 +0530 As per the Telangana State Industrial Infrastructure Development Corporation (TSIIDC) report, Telangana is home to over 800 life sciences companies with a combined value of $ 50 billion spread across multiple segments.. Among them, more than 200 plus sites are US FDA-approved, which is the highest number of such firms located in a region anywhere in the world. As per the Industries department report, in the past 9 years, Telangana has attracted more than Rs 29,000 crore in investment in the life sciences segment and created direct and indirect jobs for more than 4.5 lakh people in the state. Overall, Telangana has witnessed a whopping 23 per cent growth rate compared to India’s 14 per cent growth rate in the life sciences segment. Currently, Telangana boasts of a global vaccine manufacturing hub in India, producing 1/3 of the global vaccine supplied from the state to the world countries. Owing to high demand during the COVID-19 period, the vaccine manufacturing capacity of biotech companies from Hyderabad has been enhanced from 9 billion doses in 2014 to 14 billion doses in 2024. In addition to this, Hyderabad has more than 20 Life Sciences and Medtech incubation centres which is the highest for any city in India. In the year 2022-23, Telangana achieved the distinction of having direct centres of four among the top global life sciences companies which include Novartis, BMS, Roche, and Sanofi. According to Ajay Kallam, Principal Secretary of Industries Department, Government of Telangana, the state has the best ecosystem for establishing the life sciences companies. “There’s a need to attract investors in the innovator and new product development segment, which will pave the way for attracting more small and big research-based institutions aligning with the needs of big players”, says Kallam. Despite these achievements, the one big thing that is missing in the life sciences sector in the state is companies investing in discoveries and inventions of innovative drug molecules to treat complex diseases threatening global healthcare. Dr S V Krishna Prasad, CEO of Cito Healthcare, says, “Although Telangana currently leads the nation in generic pharmaceuticals and contributes significantly to India's pharmaceutical exports, the real growth lies in cultivating a robust base for manufacturing and marketing innovative drugs globally”. Dr Prasad urges a departure from the prevalent practice of copying off-patented drugs and emphasises the critical need for continuous research and development to discover new molecules that can effectively address a variety of global health challenges. “Except for Dr. Reddy Laboratories, not a single entity from Telangana has dared to carry out clinical trials for the new molecule. Even for Dr. Reddy’s, the molecule which it was working on had to face failure in the phase-3 trials, ever since then, there is no major entity that has taken any notable steps towards finding out new drugs,” adds Dr Krishna Prasad. Expressing similar sentiments, Laxmi Prasanna, Executive Director of Regulatory Affairs at Pharmaceutical Export Promotion Council of India (Pharmexcil), points out that despite the financial strength of many pharmaceutical firms in Telangana, there is a reluctance to invest in the discovery or invention of new drug molecules. While the state boasts over 400 US FDA-approved manufacturing units producing generic medicines and vaccines worth $4.5 billion, Laxmi Prasanna notes a lack of confidence to innovate, positioning the life sciences sector behind its Western counterparts. “No doubt India has emerged as the Pharmacy of the World in producing and supplying affordable and good quality medicines to the world, but real recognition comes only from the original work that we can deliver. Our life sciences industry must move beyond our conventional practices and take advantage of technology and try to develop new medicines to treat diseases that have no cure to date,” observed Laxmi Prasanna. Over the past four decades, the Telangana life sciences sector has indeed achieved notable milestones, with more than 800 large Indian and global pharma companies setting their bases in and around Hyderabad, Telangana state has set its target of enhancing its drug manufacturing capacity from the current $4.8 billion to $19.1 billion by the end of 2030.   Genome Valley: The Global Hub for Life Sciences  Telangana holds the distinction of being the pioneering state in India to establish the country's first systematically developed life sciences Research and Development (R&D) cluster, known as Genome Valley. It stands as India's premier organised cluster dedicated to Life Sciences R&D and Clean Manufacturing endeavours. The cluster is equipped with state-of-the-art infrastructure, including Industrial/Knowledge Parks, Special Economic Zones (SEZs), Multi-tenanted dry and wet laboratories, and incubation facilities. With over 200 companies calling it home, Genome Valley has cultivated a scientific workforce exceeding 15,000 professionals. Its occupants include renowned global entities such as Novartis, GlaxoSmithKline, Ferring Pharma, Chemo, DuPont, Ashland, United States Pharmacopeia, Lonza, and numerous others. The cluster's success lies in its commitment to fostering innovation and collaboration in the field of life sciences. In FY 2017-18, Genome Valley was accorded with Industrial Area Local Authority (IALA) status. The IALA status enables single-point administration of the cluster, which will allow companies in Genome Valley a single-point contact for all Government approvals and further facilitate infrastructure development.  Encompassing an expansive area of 120 acres, Genome Valley hosts numerous prominent global companies spanning 18 countries worldwide. Notably, it accommodates three of India's largest vaccine manufacturers: Bharat Biotech, Biological E, and Indian Immunologicals. Distinguished as the European hub of India, Genome Valley serves as the operational base for major European corporations, including Novartis, Sandoz, Lonza, Ferring, Chemo, GSK, and others. The cluster features over 2.5 million square feet of multi-tenanted laboratory facilities, with a 500,000-square-foot facility available for lease by March 2021 and an additional 1.5 million square feet currently under development. Acknowledged as the premier cluster in India, Genome Valley secured the top rank in the ‘Life Sciences Real Estate – Opportunities & Hotspots in India’. Furthermore, an additional 120 acres of land is earmarked for industries as part of Genome Valley Phase 3 in Siddipet of Medak district. Dr SP Vasireddi,  Non-Executive Chairman and founder of Vimta Labs noted that despite pharma and life sciences players having deep pockets it is sheer reluctance and fear of loss that is acting as a big hindrance for life sciences players to invest in new drug molecule discovery. He stressed that the state and central governments must support funding in this direction and bring in innovative policy decisions to encourage more and more players to venture into new drug development projects. Vinay Kumar Nandicoori, Director of the Centre for Cellular and Molecular Biology (CCMB) also highlighted that the private pharma players who are keen on new drug discovery can foster partnerships with CCMB and utilise the vast research data available and use the services of lead scientists at the same time they could use and take advantage of new and emerging technologies like data analysis and Artificial Intelligence. Highlighting the historical struggles to lay the foundation for the life sciences ecosystem, R K Agarwal, National President, the Bulk Drug Manufacturers of India (BDM) acknowledges the challenges faced by associations in the early 1990s. The concerted efforts of various pharma and life sciences associations, despite hurdles such as tough environmental regulations and financial burdens, have resulted in the creation of a strong life sciences ecosystem in both Telangana and Andhra Pradesh. As Telangana envisions becoming a state-of-the-art hub for life sciences in India by 2030, industry experts assert that the true measure of success will be the state's ability to transition from a focus on generic drugs to pioneering innovative solutions. The future of life sciences in Telangana lies not in replication but in the pursuit of groundbreaking discoveries and inventions that will shape the landscape of global healthcare.   Amguth Raju (hyderabad@mmactiv.com) ]]> <![CDATA[Dr. Reddy's enters into distribution partnership with Sanofi Healthcare India for vaccine brands]]> https://biospectrumindia.com/news/95/24431/dr-reddys-enters-into-distribution-partnership-with-sanofi-healthcare-india-for-vaccine-brands.html https://biospectrumindia.com/news/95/24431/dr-reddys-enters-into-distribution-partnership-with-sanofi-healthcare-india-for-vaccine-brands.html Wed, 27 Mar 2024 00:00:00 +0530 Hyderabad-based Dr. Reddy’s Laboratories has entered into an exclusive partnership with Sanofi Healthcare India to promote and distribute their vaccine brands across private markets in India. Under the arrangement, Dr. Reddy’s will have exclusive rights to promote and distribute Sanofi’s well established and trusted paediatric and adult vaccine brands Hexaxim®, Pentaxim®, Tetraxim®, Menactra®, FluQuadri®, Adacel® and Avaxim® 80U. These brands saw combined sales of approx. Rs 426 crore (approx. $51 million) as per IQVIA MAT February 2024. Sanofi will continue to own, manufacture, and import these brands to the country. M.V. Ramana, Chief Executive Officer, Branded Markets (India and Emerging Markets), Dr. Reddy’s said, "The portfolio now gives Dr. Reddy’s a strong presence in the vaccine segment, propelling us to the second position among vaccines players in India. Through each product and partnership, our aim is to serve over 1.5 billion patients by 2030.” ]]> <![CDATA[IIT-G & BioMed to roll out first recombinant vaccine for Swine Fever Virus]]> https://biospectrumindia.com/news/95/24426/iit-g-biomed-to-roll-out-first-recombinant-vaccine-for-swine-fever-virus.html https://biospectrumindia.com/news/95/24426/iit-g-biomed-to-roll-out-first-recombinant-vaccine-for-swine-fever-virus.html Tue, 26 Mar 2024 00:00:00 +0530 The Indian Institute of Technology Guwahati (IIT-G) has successfully transferred a pioneering vaccine technology to BioMed, a Ghaziabad-based manufacturing company specialising in high-quality vaccines. This technology entails a recombinant vector vaccine designed specifically for combating the classical swine fever virus in pigs and wild boars, filling a significant gap in India's vaccine landscape. This first recombinant virus-based vaccine for pigs harnesses a reverse genetic platform pioneered and refined at IIT-G. Swine fever, a highly contagious disease among pigs, poses a severe threat with a very high mortality rate, although it does not affect humans. In India, instances of this disease have been frequently observed in northeastern states, as well as in Bihar, Kerala, Punjab, Haryana, and Gujarat, among others. The vaccine work was started in 2018-2019 through collaborative efforts between researchers from the Department of Biosciences and Bioengineering at IIT Guwahati, and Assam Agricultural University in Guwahati.  In an intriguing approach, researchers have utilised the Newcastle disease virus (NDV), traditionally studied for its pathogenicity in chickens, as a carrier for the essential proteins of the classical swine fever virus. This innovative method facilitates the development of immunity in the body and is characterized by its speed and cost-effectiveness. At present, the vaccine is under the process of filing test and analysis licence. ]]> <![CDATA[Gennova BioPharma launches small pack size of HAMSYL drug for paediatric cancer care]]> https://biospectrumindia.com/news/95/24344/gennova-biopharma-launches-small-pack-size-of-hamsyl-drug-for-paediatric-cancer-care.html https://biospectrumindia.com/news/95/24344/gennova-biopharma-launches-small-pack-size-of-hamsyl-drug-for-paediatric-cancer-care.html Fri, 08 Mar 2024 00:00:00 +0530 Pune-based Gennova Biopharmaceuticals has announced the launch of India’s first paediatric pack size of pegaspargase, HAMSYL – Junior, which will now be available in a 1500 IU pack size. This marks a significant milestone in advancing healthcare for Indian children suffering from an orphan disease called Acute Lymphoblastic Leukaemia (ALL), a rare and challenging form of blood cancer primarily affecting children.  Gennova's commitment to addressing ALL began in 2014 with the introduction of HAMSYL, an affordable and quality-assured pegaspargase available in 3750 IU pack size. Notably, this product supported access to the needs of patients against a time-consuming and cumbersome process of importing the drug and reduced the cost of the then-available standard of care in terms of drug pricing, in the fight against ALL. Initially approved for the second-line treatment of ALL, HAMSYL received recognition for its safety and efficacy in real-world patients. This paved the way for its approval as a first-line therapy in 2019, a testament to its demonstrated bioequivalence with the innovator molecule. Following the HAMSYL launch, Gennova's engagement with Key Opinion Leaders in paediatric haematology revealed the need for a different pack size specifically made for children. In response, Gennova introduced HAMSYL Junior, involving subsequent new drug applications with CDSCO, New Delhi, to modify the pack size. This will not only suit the smaller body size but also prevent wastage. With a 1500 IU pack size and a 2 mL fill volume, HAMSYL Junior ensures optimal dosing while retaining the same API strength (750 IU/mL), marking a significant stride in providing paediatric patients in India with a specifically designed and accessible treatment.   ]]> <![CDATA[Cadila Pharmaceuticals introduces quadrivalent influenza vaccine]]> https://biospectrumindia.com/news/95/24310/cadila-pharmaceuticals-introduces-quadrivalent-influenza-vaccine.html https://biospectrumindia.com/news/95/24310/cadila-pharmaceuticals-introduces-quadrivalent-influenza-vaccine.html Mon, 04 Mar 2024 00:00:00 +0530 Ahmedabad-based Cadila Pharmaceuticals has announced the launch of Cadiflu  Tetra  Vaccine,  an  advanced  Quadrivalent Influenza Vaccine to prevent influenza, a recurrent, widespread and debilitating viral infection. The vaccine is approved by Drugs Controller General of India (DCGI) for use in adults and children. Cadiflu  Tetra  Vaccine  targets  four  strains  of  the  Influenza  virus  subtype–A  and  B,  responsible  for seasonal  epidemics.  Developed  using  cutting-edge  proprietary  technology  employing  nano-sized particles, the  vaccine mimics  the  external  structure  of  the  virus  without  containing  intact  genetic material. The  vaccine carries hemagglutinin (HA), neuraminidase (NA) and matrix  1  (M1)  proteins  from  the respective  strains  aggregated  together in a single  formulation.  The  VLP  vaccine  replicates  external structure of the viruses but does not contain any live genetic substance, which can cause viral replication and infection. Therefore, this vaccine is qualitatively superior and has better safety profile.  The Cadiflu Tetra Vaccine aims to reduce the incidence of influenza illness, mitigate the severity of the disease  in  affected  individuals,  and  decrease  the  transmission  of  the  infection  to  others.  This breakthrough  in  vaccine  development  also  holds  promise  for  enhancing  the  protection  of  pregnant women against influenza, contributing to the overall well-being of both mother and child.   ]]> <![CDATA[Biocon Biologics to launch Stelara biosimilar in US in Feb 2025, post FDA approval]]> https://biospectrumindia.com/news/95/24299/biocon-biologics-to-launch-stelara-biosimilar-in-us-in-feb-2025-post-fda-approval.html https://biospectrumindia.com/news/95/24299/biocon-biologics-to-launch-stelara-biosimilar-in-us-in-feb-2025-post-fda-approval.html Thu, 29 Feb 2024 00:00:00 +0530 Bengaluru-based Biocon Biologics has signed a settlement and license agreement with Janssen Biotech Inc., and Johnson & Johnson, that clears the way to commercialise its Bmab 1200, a proposed biosimilar to Stelara, in the United States of America. The agreement licenses the company to launch in the United States (US), in February 2025, once approved by the US Food and Drug Administration (FDA). The USFDA has accepted the company's Biologics License Application (BLA) for Bmab 1200 (bUstekinumab) for review under the 351(k) pathway. Biocon Biologics and Janssen have finalised the settlement agreement to dismiss the pending Inter Partes Review (IPR) for US 10961307 before the Patent Trial and Appeal Board (PTAB) of the United States Patent and Trademarks Office. Stelara (Ustekinumab) is a monoclonal antibody medication that prevents abnormal regulation of interleukin IL-12/23 associated immune diseases and has been approved for the treatment of psoriasis, Crohn's disease, ulcerative colitis, plaque psoriasis and psoriatic arthritis. The reference brand, Stelara, had sales of $7 billion in the United States in 2023. Biocon Biologics has commercialised eight biosimilars in key emerging markets and advanced markets like US, EU, Australia, Canada, Japan. ]]> <![CDATA[Serum Institute of India joins CEPI to boost production of affordable outbreak vaccines]]> https://biospectrumindia.com/news/95/24106/serum-institute-of-india-joins-cepi-to-boost-production-of-affordable-outbreak-vaccines.html https://biospectrumindia.com/news/95/24106/serum-institute-of-india-joins-cepi-to-boost-production-of-affordable-outbreak-vaccines.html Wed, 24 Jan 2024 00:00:00 +0530 Pune-based vaccine manufacturer Serum Institute of India (SII) is joining a growing Coalition for Epidemic Preparedness Innovations (CEPI) network of vaccine producers in the Global South to support more rapid, agile, and equitable responses to future public health disease outbreaks. The addition of SII to the Norway-based CEPI manufacturing network will be a significant boost to vaccine production efforts in Global South regions and will mean the world is better prepared to achieve the 100 Days Mission to develop new vaccines against known or novel infectious diseases within three months of a pandemic threat being recognised. To prepare for such a scenario, CEPI is investing up to $30 million to build upon SII’s proven track record of rapid response to outbreaks of infectious disease, expanding the company’s existing ability to swiftly supply investigational vaccines in the face of epidemic and pandemic threats. This would then enable CEPI-backed vaccine developers to quickly transfer their technology to SII within days or weeks of an outbreak to begin rapid production and equitable distribution of affordable vaccines to affected populations. Created by CEPI to expand the global footprint of vaccine production, the manufacturing network focuses on vaccine makers in the Global South near areas at high risk of outbreaks caused by deadly viral threats like Lassa Fever, Nipah, Disease X, and other pathogens with epidemic or pandemic potential prioritised by CEPI. Given SII’s already proven production capabilities, in the event of an outbreak the company may be called upon to promptly supply investigational vaccines for preclinical and clinical testing as well as large-scale supply. With CEPI’s funding, SII will also support the development, stockpiling and licensure of new vaccines against CEPI’s priority pathogens. CEPI and SII are exploring which CEPI-backed vaccines SII will support.   ]]> <![CDATA[Indian Immunologicals rolls out India's first indigenously developed Hepatitis A vaccine ]]> https://biospectrumindia.com/news/95/24089/indian-immunologicals-rolls-out-indias-first-indigenously-developed-hepatitis-a-vaccine-.html https://biospectrumindia.com/news/95/24089/indian-immunologicals-rolls-out-indias-first-indigenously-developed-hepatitis-a-vaccine-.html Sun, 21 Jan 2024 00:00:00 +0530 Hyderabad-based Indian Immunologicals Ltd (IIL), a wholly owned subsidiary of National Dairy Development Board (NDDB), marks a historic moment in public health with the launch of India’s first indigenously developed Hepatitis A vaccine Havisure.  This indigenously developed vaccine is poised to play a crucial role in preventing Hepatitis A, a highly contagious liver infection that poses a significant public health challenge. Hepatitis A is a viral infection primarily spread through the fecal-oral route, meaning that it is transmitted through the ingestion of contaminated food or water.  This novel vaccine was launched in the presence of Nagaraj Karpan, MLA and Ajay Mishra, IAS-Chairman Indian Redcross Society, Telangana.  Speaking on the occasion, Dr K Anand Kumar, Managing Director, Indian Immunologicals shared "Currently Hepatitis A vaccines are imported into our country. The vaccine Havisure has undergone extensive clinical trials in 8 centres and has proven to be safe and efficacious. The vaccine is comparable to the world’s leading vaccine sold by a multinational. With Havisure, we aim to contribute significantly to the prevention of this infectious disease." Havisure is effective in preventing the disease and is recommended for children in the routine immunisation. It is a two-dose vaccine wherein the first dose is administered at above 12 months of age and the second dose is given at least after 6 months of the first dose. The vaccine is also recommended for individuals who are at risk of exposure or travel to the regions with high hepatitis A prevalence. In addition to this people with occupational risk of infection and suffering from chronic liver diseases also need Hepatitis A vaccination.  Dr Priyabrata Pattnaik, Dy. Managing Director, IIL said, “The company has considerably invested in state-of-the-art manufacturing facilities to scale up production and meet the growing demand for Hepatitis A vaccine. As part of the launch, IIL will be collaborating with healthcare professionals, corporate hospitals, and government agencies to promote awareness about Hepatitis A and the importance of both paediatric, adolescent & adult vaccination”.    ]]> <![CDATA[WHO grants Emergency Use Listing to Biological E's COVID-19 vaccine Corbevax]]> https://biospectrumindia.com/news/95/24077/who-grants-emergency-use-listing-to-biological-es-covid-19-vaccine-corbevax.html https://biospectrumindia.com/news/95/24077/who-grants-emergency-use-listing-to-biological-es-covid-19-vaccine-corbevax.html Wed, 17 Jan 2024 00:00:00 +0530 Biological E (BE), a Hyderabad-based vaccines and pharmaceutical company, has announced that the World Health Organisation (WHO) has granted an Emergency Use Listing (EUL) to their Corbevax vaccine, which is India's first indigenously developed COVID-19 vaccine that is based on protein sub-unit platform. The Drugs Controller General of India (DCGI) already approved the vaccine for restricted use in emergency among adults, adolescents and young children in a sequential manner from December’21 to April’22; as well as India’s first heterologous COVID-19 booster shot for adults age 18 and above in June’22.  BE supplied 100 million doses of Corbevax  to the Government of India which were then utilised in pan-India immunisation campaigns; mainly in 12-14 yr old children.  Mahima Datla, Managing Director, Biological E. said “While several companies which entered the field of vaccine development & manufacturing during the COVID-19 pandemic exited soon afterwards either due to paucity of funds or lack of success, BE continues to remain committed to develop and provide access to high quality affordable vaccines globally by constantly enlarging its portfolio of offerings.’’  BE has been working on a next-generation COVID-19 vaccine that is based on the XBB1.5 variant of the SARS-CoV-2 virus, which would conform to WHO TAG-CO-VAC recommendations. BE's candidate vaccine has completed all required pre-clinical animal studies, which suggest that it will provide adequate protection against the currently circulating variants. BE has recently received final approval from CDSCO to begin clinical trials of the XBB.1.5 variant vaccine in India. The clinical trials will commence soon at various trial sites in India.  BE already qualified manufacturing infrastructure for producing variant vaccines to initiate supply at a short notice.   ]]> <![CDATA[Cipla announces joint venture in US with Kemwell Biopharma and Manipal Education & Medical Group]]> https://biospectrumindia.com/news/95/24056/cipla-announces-joint-venture-in-us-with-kemwell-biopharma-and-manipal-education-medical-group.html https://biospectrumindia.com/news/95/24056/cipla-announces-joint-venture-in-us-with-kemwell-biopharma-and-manipal-education-medical-group.html Tue, 09 Jan 2024 00:00:00 +0530 Cipla (EU) Limited, UK, a wholly owned subsidiary of Mumbai-based pharma firm Cipla Limited, has announced a strategic collaboration with Kemwell Biopharma Private Limited (through its subsidiary Kemwell Biopharma UK Limited) and Manipal Education & Medical Group (through its subsidiary MNI Ventures, Mauritius) to incorporate a joint venture in the United States (US). The primary goal of this joint venture is to develop and commercialise novel cell therapy products for major unmet medical needs in the United States, Japan, and EU regions. Cipla (EU) Limited will secure a 35.2% stake in the joint venture company. By capitalising on Cipla's leadership in product development and commercialisation and aligning with Kemwell's expertise in biologics and Manipal's expertise in healthcare delivery, this strategic collaboration is aimed at expediting development, manufacturing, licensing, import and export of cutting-edge cell therapy products to cater to patients globally. This marks the second joint venture between Cipla and Kemwell Biopharma, following the incorporation of Aspergen Inc., USA in 2022 for the development, manufacturing, and commercialisation of biosimilars for global markets. Aspergen Inc. is actively developing two projects, with several others under evaluation, accelerating Cipla's global lung leadership agenda and strengthening the company's position in the biosimilar market for long-term, diversified growth. ]]> <![CDATA[Indian Immunologicals invests Rs 700 Cr in new vaccine manufacturing plant at Genome Valley]]> https://biospectrumindia.com/news/95/24023/indian-immunologicals-invests-rs-700-cr-in-new-vaccine-manufacturing-plant-at-genome-valley.html https://biospectrumindia.com/news/95/24023/indian-immunologicals-invests-rs-700-cr-in-new-vaccine-manufacturing-plant-at-genome-valley.html Fri, 29 Dec 2023 00:00:00 +0530 Indian Immunologicals Limited (IIL) has started construction of its new greenfield veterinary vaccine facility to manufacture the Foot and Mouth Disease Vaccine (FMD-Vac) as well as Foot and Mouth Disease + Haemorrhagic Septicaemia Vaccine (FMD+HS-Vac) in Hyderabad’s Genome valley. This brand-new unit will have a BSL3 facility for the manufacture of drug substances and a fill-finish capability for the production of both drug products FMD vaccine and the FMD+HS vaccine. Telangana State Industrial Infrastructure Corporation Ltd (TSIIC), a Government of Telangana undertaking, had allotted the land to IIL at Biotech Park, Phase III, Karkapatla, Siddipet district in Telangana. The proposed facility has a capacity of 150 million doses/annum of FMD vaccine or FMD+HS vaccine each. With an investment of approximately Rs 700 crore, the proposed facility is expected to create more than 750 direct and indirect jobs.  Dr K Anand Kumar, Managing Director, IIL said, “We are the largest supplier of FMD vaccine to Government of India’s prestigious Livestock Health Disease Control Programme (LHDCP). We are in an exponential growth phase and expected to grow 40% this year alone. In order to sustain the momentum, IIL is seriously considering making additional investments in building infrastructure within India and in other emerging geographies including Africa in a manner to develop tools that will help in control and eradication of diseases.”   ]]> <![CDATA[PNB VESPER signs agreements with US-based National Institute on Drug Abuse to tackle addiction disorders]]> https://biospectrumindia.com/news/95/23936/pnb-vesper-signs-agreements-with-us-based-national-institute-on-drug-abuse-to-tackle-addiction-disorders.html https://biospectrumindia.com/news/95/23936/pnb-vesper-signs-agreements-with-us-based-national-institute-on-drug-abuse-to-tackle-addiction-disorders.html Mon, 11 Dec 2023 00:00:00 +0530 In a significant development, PNB VESPER, a research-based biopharmaceutical company headquartered in Kochi, Kerala has signed agreements with the National Institute on Drug Abuse (NIDA), under National Institutes of Health (NIH) USA, the lead federal agency supporting scientific research on drug abuse and addiction disorders, to develop drugs for opioid and cocaine addiction disorders. As per the agreements, NIDA will evaluate three of the molecules developed by PNB VESPER- PNB 091, PNB 081 and PNB 101 as potential drugs for the treatment of opioid and cocaine addiction-related disorders.  PNB VESPER, which has completed the preclinical studies of the molecules, will soon file the Investigational New Drug applications with the US Food and Drug Administration. The company is planning to start clinical trials of the molecules in the US as soon as it completes the ongoing studies with NIDA and IND studies, which will be over before end of 2024.Drug overdose and abuse is a major public health crisis in the USA as well as globally. The national spending on addiction-related disorders is close to $700 billion annually. Opioid addiction is a chronic disease that causes major health, social and economic problems. In the past 15 years, various initiatives were launched by the US government and spent billions of dollars to develop safe drugs for the disorders. ]]> <![CDATA[Indian Immunologicals unveils Measles and Rubella vaccine for children]]> https://biospectrumindia.com/news/95/23888/indian-immunologicals-unveils-measles-and-rubella-vaccine-for-children.html https://biospectrumindia.com/news/95/23888/indian-immunologicals-unveils-measles-and-rubella-vaccine-for-children.html Sat, 25 Nov 2023 00:00:00 +0530 Hyderabad-based Indian Immunologicals Limited (IIL) has launched Mabella (Measles and Rubella) vaccine for children, developed in partnership with Polyvac Institute, Vietnam. Through rigorous human clinical trials, Mabella has demonstrated both safety and effectiveness. This launch took place along with Human Biologicals Institute (HBI), a branch of IIL, marking its 25th anniversary since its establishment in 1998. Founded in an era emphasising the need for indigenous vaccines, HBI has significantly contributed to India's self-reliance, aligning with the vision of "Atmanirbhar Bharat." HBI's legacy of innovation began in 1998 with the indigenous development of India's first safe Vero-cell rabies vaccine – Abhayrab, replacing the painful nerve tissue vaccine. Abhayrab is now the world's largest-selling Anti-Rabies vaccine, saving millions of lives globally. HBI subsequently introduced various childhood vaccines, including DPT, Pentavalent Vaccine, TT, Hepatitis-B, MR, and Td vaccines. Dr K Anand Kumar, Managing Director of Indian Immunologicals, highlighted IIL's substantial contributions to disease control and vaccine accessibility over its 25-year journey. Emphasising IIL's role in disease elimination, he discussed the launch of Mabella, addressing the global threat of Measles and Rubella, which claims around 1,00,000 children's lives annually. ]]> <![CDATA[Sanjivani Paranteral and Hindustan Antibiotics collaborate to manufacture IV formulations and IV sets]]> https://biospectrumindia.com/news/95/23872/sanjivani-paranteral-and-hindustan-antibiotics-collaborate-to-manufacture-iv-formulations-and-iv-sets.html https://biospectrumindia.com/news/95/23872/sanjivani-paranteral-and-hindustan-antibiotics-collaborate-to-manufacture-iv-formulations-and-iv-sets.html Thu, 23 Nov 2023 00:00:00 +0530 Mumbai-based Sanjivani Paranteral has inked a significant agreement with Hindustan Antibiotics, the first drug manufacturing company to be set up in the public sector by Government of India, for the manufacturing of Intravenous (IV) formulations and IV sets. The agreement is backed by a confirmed purchase commitment from Hindustan Antibiotics. The partnership will see the establishment of a cutting-edge manufacturing facility within the premises of Hindustan Antibiotics at Pimpri works, Pune. Sanjivani Paranteral will soon initiate the process of upgrading facilities, and the production is likely to start from Q3FY25. The plant capacity will be 50 lakh IV fluids bottles and 10 lakh IV sets per month. This strategic move underlines both companies' commitment to meet the demand of IV formulations and IV sets. The total investment for the project would be Rs 50 crore. Ashwani Khemka, Chairman & Managing Director of Sanjivani Paranteral said, "Our collaboration with Hindustan Antibiotics Limited not only reaffirms our commitment to innovation and healthcare quality but also aligns with our vision for advancing pharmaceutical manufacturing in India." According to Milind Palhade from Hindustan Antibiotics, “The joint venture will help to elevate the standards of pharmaceutical manufacturing, emphasising innovation, quality, and accessibility in the production of IV formulations and IV sets. Both the companies are positive about the transformative impact this collaboration will have on healthcare delivery in India.”   ]]> <![CDATA[Novo Nordisk invests Kr. 42 B+ for expansion of manufacturing facilities in Denmark]]> https://biospectrumindia.com/news/95/23831/novo-nordisk-invests-kr-42-b-for-expansion-of-manufacturing-facilities-in-denmark.html https://biospectrumindia.com/news/95/23831/novo-nordisk-invests-kr-42-b-for-expansion-of-manufacturing-facilities-in-denmark.html Mon, 13 Nov 2023 00:00:00 +0530 Novo Nordisk has announced plans to invest more than 42 billion Danish kroner (Kr.) starting in 2023 to expand existing manufacturing facilities in Kalundborg, Denmark, for the current and future product portfolio within serious chronic diseases. The investment comes as Novo Nordisk marks the 100th anniversary of its founding in Denmark, where more than 23,000 employees still work today. Most of these employees work at production sites. The investment will create additional capacity across the entire global value chain from manufacturing of active pharmaceutical ingredients (API) to packaging, with the vast majority invested in API capacity. The new API facility will be designed as a multi-product facility, with flexibility to accommodate current and future processes. The investment, which includes GLP-1 products, will increase Novo Nordisk’s ability to meet future market demands. The new API facility will have a footprint of 170,000 sq mt. It will be designed as a multi-product facility with flexibility to accommodate future processes and displaying state-of-the-art technology and working environment. As a future-proof and cost-effective facility, the construction will focus on delivering the highest quality to patients globally in an efficient and environmentally sustainable way. The construction projects will be finalised gradually from the end of 2025 through 2029. The projects are expected to create 8003 new jobs in the facilities when construction is completed, and the facilities are fully equipped. During the construction phase, up to 3,000 external employees will be employed. ]]> <![CDATA[USV partners with Biogenomics to launch first biosimilar Insulin Aspart for diabetics In India]]> https://biospectrumindia.com/news/95/23817/usv-partners-with-biogenomics-to-launch-first-biosimilar-insulin-aspart-for-diabetics-in-india.html https://biospectrumindia.com/news/95/23817/usv-partners-with-biogenomics-to-launch-first-biosimilar-insulin-aspart-for-diabetics-in-india.html Wed, 08 Nov 2023 00:00:00 +0530 Mumbai-based USV Pvt Ltd and Biogenomics (based in Thane) have announced the launch of INSUQUICK, India’s first biosimilar Insulin Aspart, which will improve access for people with diabetes. InsuQuick is a “Make in India” product, developed and manufactured using 100% indigenous technology, and has undergone a robust clinical programme to ensure global quality standards. It is available in all metros, and Tier I/II cities. Prashant Tewari, Managing Director, USV, said," Our entry into injectables is a strategic step towards bolstering our market presence and our aspiration to lead in the diabetes market. We have collaborated with Biogenomics to provide global-quality insulin aspart for our people with diabetes. Dr Sanjay Sonar, Co-Founder and President of Biogenomics, said, “Insulin aspart is the first biosimilar in the category of rapid-acting insulin and is a result of more than ten years of R&D efforts. Insuquick will be available in cartridges, vials, and prefilled disposable pens, offering flexibility tailored to the needs of people with diabetes. The disposable and reusable pens are contemporary and lightweight in design and have a legible scale and audible clicks for precise incremental settings. Insulin Aspart is intended to be the stepping stone for USV’s entry into the insulin market. The company will continue to expand in the coming years with robust R&D to deliver comprehensive solutions to people with diabetes. ]]> <![CDATA[Zydus Lifesciences acquires UK based LiqMeds Group for Rs 688 Cr]]> https://biospectrumindia.com/news/95/23779/zydus-lifesciences-acquires-uk-based-liqmeds-group-for-rs-688-cr.html https://biospectrumindia.com/news/95/23779/zydus-lifesciences-acquires-uk-based-liqmeds-group-for-rs-688-cr.html Wed, 01 Nov 2023 00:00:00 +0530 Ahmedabad-based Zydus Lifesciences, through its wholly owned subsidiary Zydus Pharmaceuticals UK Limited, has announced the acquisition of the UK headquartered LiqMeds Group of companies which has capabilities and specialisation in development, manufacturing and supply of oral liquid products for global markets, which it currently commercialises through partners. The group’s subsidiary LM Manufacturing Limited (LMML), has an oral liquids manufacturing site at Weedon, Northampton, UK, which supplies products to the US and UK markets. Zydus will pay an upfront consideration of GBP 68 million (Rs 688 crore approximately) and yearly earn-outs until 2026 depending on achievement of certain agreed milestones towards acquisition of the LiqMeds Group of companies. The transaction will be EPS accretive for Zydus from the first year of acquisition. Speaking on the development, Managing Director of Zydus Lifesciences, Dr Sharvil Patel said, “We believe that liquid orals is a large, growing market and serves unmet needs with significant new market expansion opportunities. In line with our patient-centric approach, we believe that oral liquid formulations would help geriatric and paediatric patients, bringing in greater ease of convenience and therapy compliance.” ]]> <![CDATA[Zydus Lifesciences initiates Ph II clinical trial for treatment of Amyotrophic Lateral Sclerosis]]> https://biospectrumindia.com/news/95/23746/zydus-lifesciences-initiates-ph-ii-clinical-trial-for-treatment-of-amyotrophic-lateral-sclerosis.html https://biospectrumindia.com/news/95/23746/zydus-lifesciences-initiates-ph-ii-clinical-trial-for-treatment-of-amyotrophic-lateral-sclerosis.html Wed, 25 Oct 2023 00:00:00 +0530 Ahmedabad-based company Zydus Lifesciences has received permission from the Central Drugs Standard Control Organisation (CDSCO), Government of India, to initiate the Phase II clinical study of NLRP3 inhibitor “ZYIL1” in patients with Amyotrophic Lateral Sclerosis (ALS). Pankaj R. Patel, Chairman, Zydus Lifesciences said, “By targeting neuroinflammation and neurodegeneration with ZYIL1, we hope to open up new possibilities in treating ALS.” ALS patients experience neuroinflammation and rapid neurodegeneration leading to steady loss of the ability to move, speak, eat and eventually breathe. ALS results in loss of motor neurons in the brain and spinal cord which controls voluntary muscle movement. The Phase II clinical trial will study safety, tolerability, pharmacokinetics and pharmacodynamics in patients with ALS. The change from baseline in the Revised Amyotrophic Lateral Sclerosis Functional Rating Scale (ALSFRS-R) score will be measured at week 4, week 8 and week 12, as the trial’s primary endpoint is the placebo-controlled, randomised, double-blind Phase 2 clinical trial. The trial will also evaluate Key Secondary Endpoints including Slow Vital Capacity (SVC), a predictor of functional loss in ALS and neurofilament levels at week 4 and week 12. ZYIL1 is a novel oral small molecule NLRP3 inhibitor. Studies have demonstrated that ZYIL1 is highly potent in human whole blood assay and can suppress inflammation caused by the NLRP3 inflammasome. ZYIL1 was found distributed in the brain and CSF of various nonclinical species including mice, rats and non-human primates. The efficacy of ZYIL1 has been established in several validated pre-clinical models of neuroinflammation, Parkinson’s disease, Inflammatory Bowel Disease (IBD) and Multiple Sclerosis (MS).    ]]> <![CDATA[Bharat Serums and Vaccines invests Rs 200 Cr in new biopharmaceutical manufacturing plant in Genome Valley]]> https://biospectrumindia.com/news/95/23620/bharat-serums-and-vaccines-invests-rs-200-cr-in-new-biopharmaceutical-manufacturing-plant-in-genome-valley.html https://biospectrumindia.com/news/95/23620/bharat-serums-and-vaccines-invests-rs-200-cr-in-new-biopharmaceutical-manufacturing-plant-in-genome-valley.html Thu, 21 Sep 2023 00:00:00 +0530 Bharat Serums and Vaccines Limited (BSV) hosted the groundbreaking ceremony of its new manufacturing plant at Genome Valley in Hyderabad, Telangana, in the presence of K.T Rama Rao, Minister for Municipal Administration and Urban Development; Industries and Commerce; and Information Technology, Electronics and Communications of Telangana. BSV currently has a manufacturing facility in Ambernath, Maharashtra that caters to domestic and more than 80 export markets and a manufacturing facility in Aachen, Germany, that serves the international markets. The new manufacturing facility in Genome Valley will cover an area of 10 acres and involve an investment of Rs 200 crore.  It aims to provide long-term employment opportunities to the people of the Telangana State as well as upskilling of capabilities.  With this manufacturing facility, BSV aims to significantly increase its capacity in producing injectables with the commissioning of the fill-finish formulation line in phase 1 and an additional multi-product line in phase 2 of the project. The manufacturing facility endeavors to produce world-class products that adhere to International Quality Systems while complying to the Indian regulatory norms of Schedule M as well as the Global regulatory requirements in the world. The facility will produce women health products, rabies vaccines, immunoglobulins, hormones, among others.     ]]> <![CDATA[Biocon buys Eywa Pharma’s oral solid dosage manufacturing facility in US for $7.7 M]]> https://biospectrumindia.com/news/95/23540/biocon-buys-eywa-pharmas-oral-solid-dosage-manufacturing-facility-in-us-for-7-7-m.html https://biospectrumindia.com/news/95/23540/biocon-buys-eywa-pharmas-oral-solid-dosage-manufacturing-facility-in-us-for-7-7-m.html Mon, 04 Sep 2023 00:00:00 +0530 Bengaluru-based biopharmaceutical company Biocon has announced that its step-down, wholly-owned subsidiary, Biocon Generics Inc., has acquired Eywa Pharma Inc.’s oral solid dosage manufacturing facility, located in Cranbury, New Jersey, US, effective 1st September, 2023. The facility is acquired for a total consideration of $7.7 million. As part of the acquisition, the existing workforce of the facility will transition to Biocon Generics Inc. The facility has a potential for capacity expansion up to 2 billion tablets/capsules per year. Siddharth Mittal, Managing Director and CEO, Biocon Limited said, “The acquisition of this US FDA approved facility, our first in the US, will complement Biocon’s existing manufacturing capabilities and strengthen our foothold in the United States. The acquisition will also enable us to add oral solid dosage capacities for new products earlier than originally planned and ensure continuity of supply through the diversification of our manufacturing infrastructure. Our focus will be on integrating the acquired facility expeditiously and expanding our portfolio in the region.” ]]> <![CDATA[Scouting for best talent]]> https://biospectrumindia.com/features/95/23511/scouting-for-best-talent.html https://biospectrumindia.com/features/95/23511/scouting-for-best-talent.html Fri, 01 Sep 2023 00:00:00 +0530 The words talent and talent crunch are intertwined and we come across these terms from various companies' CEOs, CFOs, HR and social media posts. Despite India being one of the most populous nations in the globe, there seems to be something amiss when it comes to going in for the right talent. Above it, unemployed-friendly stringent HR policies restrain the right talent to join a firm. The pharma and the life sciences sector is no exception to this where leaders have been often speaking about the need for the right talent. The life sciences industry, particularly in the pharmaceutical and biopharmaceutical sectors, has been experiencing rapid growth and significant technological advancements. The development of innovative therapies, personalised medicine and biotechnological breakthroughs has increased the demand for specialised talent with expertise in areas like gene editing, immunotherapy and bioinformatics. Advances made in artificial intelligence (AI) and machine learning (ML) have created a massive need for data scientists and researchers. Diagnostics and medical devices sector is also seeing a major talent need in product development and sales.   Struggles The life sciences industry, like several other non-tech sectors, has come to rely heavily on emerging technologies, ranging from AI/ML to data analytics and robotics. Hence, the obstacle is finding qualified tech candidates with niche skill sets that are in demand across industries. Proficiency in digital skills and domain knowledge becomes imperative to the growth of the industry. According to Munira Loliwala, Assistant Vice President, TeamLease Digital, “Ageing workforce, creating a shortage of skilled workers to replace at senior and specialised roles, becomes challenging when multiple companies are vying for the same pool of skilled professionals. Regulatory challenges-compliance with these regulations requires specialised knowledge and expertise. The complexity of roles and limited investments in training and development due to lack of time are some of the reasons that lead to constant attrition.” Sometimes, mergers and acquisitions disrupt the workforce, leading to redundancies, and potential talent drain are some of the key reasons for the talent crunch. According to industry estimates, 69 per cent or more professionals are constantly looking for other jobs in lieu of professional development and monetary gain, thus leading to high attrition across this sector.  Other contributing factors include fresh graduates and candidates lacking industry exposure and relevant internships, making it difficult for them to meet specific pharmaceutical company requirements. Stringent regulatory requirements also demand high levels of compliance, increasing the complexity of hiring and retaining talent in the industry.  The ageing workforce poses challenges as experienced professionals approach retirement age, necessitating the need for skilled replacements. Additionally, with digital transformation becoming prevalent, there is a growing demand for professionals with expertise in data analytics, artificial intelligence, and digital marketing, which are in short supply within the pharmaceutical talent pool.   Attrition The industry is currently confronted with a critical challenge - a severe shortage of skilled professionals and a high attrition rate in pharmaceutical companies, with double-digit attrition standing at 15.67 per cent. These factors are hindering the industry’s growth and innovation potential. Furthermore, the elevated attrition rates worsen the existing talent gap, underscoring the importance of companies adopting comprehensive strategies to attract, retain, and develop skilled talent.           According to the Society for Human Resource Management (SHRM), the impact of inflation is particularly noteworthy, with one in four life sciences and pharma leaders stating that it has negatively affected their business. Moreover, 76 per cent of these leaders anticipate that uncertainty about the economy, inflation, and labour costs will influence their hiring strategies, surpassing the global average of 66 per cent by 10 basis points. Says Achal Khanna, CEO – SHRM India, APAC & MENA, "The causes of the skills shortage in the pharmaceutical industry are multi-faceted. Firstly, the current educational programmes may not align with industry demands, leading to a workforce that is not adequately prepared for the pharmaceutical sector's evolving needs. Additionally, the lack of substantial investment in research and development has resulted in a scarcity of skilled researchers and scientists, impacting the industry's ability to pioneer innovations. Moreover, the allure of better opportunities abroad has led to a brain drain in the pharmaceutical sector, with skilled professionals seeking employment opportunities in other countries. This situation is compounded by competition from other sectors like IT and e-commerce, which are also vying for the same pool of skilled workers." Talking on the same lines, Sachin Alug, CEO, NLB Services (a talent solutions company, providing workforce solutions globally) says, “It was reported that the post-pandemic attrition rate in the sector was over 20 per cent higher than the pre-pandemic levels. This shift can be attributed to the high demand for superior tech skills across verticals. Through the right skill sets, candidates can obtain better opportunities in various industries, causing the attrition rate to further spike. Technology can play an important role to manage attrition in organisations. It can help businesses to find gaps in employee experience and company expectations. Aligning the two can go a long way in retaining employees and finding a path that’s mutually beneficial to both employers and employees. Fostering a positive workplace culture that motivates and recognises employees also helps control attrition.” Talking more about the attrition issues, Punam G Kaushik, Deputy Managing Director of Meteoric Biopharmaceutical, opines, “Indeed, attrition levels have been a cause for concern. The highly competitive nature of the industry, coupled with the ever-evolving opportunities in research, development, and product commercialisation, has led to a revolving door of talent. Top-tier and middle-tier professionals are constantly seeking new career challenges and advancements, creating a challenge for organisations to retain their best minds. Biopharma companies are placing greater emphasis on talent retention strategies to address the attrition challenge.” Darren Punnen, Pharma and Life sciences Practice, Leader, Europe Practice, Nishith Desai Associates says that the current dip being seen in the market is also from the decrease in overall graduates entering the workforce from STEM courses. He adds, “The main focus should be to bring back interest in the STEM field in order to increase the talent pool. While the interest is gradually rising again, organisations should attempt to keep the student community aware of the various opportunities in this field, so that the trend does not seize.”  Talking about the attrition, he goes on to mention that attrition levels tend to be relatively high as there are a number of organisations competing to attract a small talent pool. When the role requires relevant work experience, there is even more competition with high incentives, causing increased movement between organisations. At an employee level, a smaller workforce means higher workload per person. Additionally, projects in this sector are fairly long-term, so employees are not able to see a tangible outcome for years together.”   The way out Investment in skills and skilled candidates is a way worth exploring. To keep up the dynamism and adaptability of employees and the organisation, skilling and training initiatives must become an integral part of talent management. In order to stop falling back on reactive hiring, companies must create access to a readily available talent community and strengthen their talent pipeline for the future. Suresh Pattathil, President, the Organisation of Pharmaceutical Producers of India (OPPI) states, “The pharmaceutical market in India is rapidly evolving, pivoting towards specialised innovative molecules and products. This shift necessitates a robust influx of talent across key functions such as medical affairs, manufacturing and regulatory affairs, and a specialised high-calibre professional cohort well-versed in advanced scientific concepts. India currently possesses a reservoir of skilled professionals in these domains; with an expected increasing need which is witnessed by the large scale Global Business Centre’s established by OPPI members companies to support the global pharma markets, recruiting and training large numbers of talent building the intellectual capital for the India healthcare environment.” Mayank Chandra, Managing Partner, Antal International mentions, "These days this has been observed that few companies (including some global ones as well) have decreased the percentage increment while doing internal appraisals. Taking care of proper and defined career progression, providing enough autonomy and double-digit appraisals might help to minimise attrition. Other factors like flexibility at work/hybrid working model, upgraded talent management practices, and competency mapping are also very relevant while attempting to retain talent." Appreciations in terms of rewards and recognition/defined career progression/autonomy / approachable management/flexible work culture (timing, mode etc) / proper employee engagement and team bonding activities are some of the measures that will help to retain talent. Better talent management practices and competency mapping, quicker interview process are some of the other things that need to be looked into. Technology can play an important role to manage attrition in organisations. It can help businesses to find gaps in employee experience and company expectations. Aligning the two can go a long way in retaining employees and finding a path that’s mutually beneficial to both employers and employees. Fostering a positive workplace culture that motivates and recognises employees also helps control attrition. As per the India Skill report 2022, there has been slight improvement in employment and job readiness level in the pharma sector to 44 per cent. However, there is still a long way to go and there is an urgent need for enhanced coordination between the Indian pharmaceutical industry, academia and government to improve the employability of the pharmaceutical students.  Industry-academia collaboration is vital to developing curricula that align with industry needs and provide students with practical experience. Increased investment in research and development can attract skilled researchers and scientists to contribute to ground breaking discoveries. Government support in terms of incentives and encouragement for research, development, and innovation can bolster the industry's talent pool. Creating attractive career opportunities by offering competitive salaries, a supportive work environment, and appealing career growth prospects can aid in retaining skilled talent. Companies can also focus on employee engagement through effective orientation programmes, providing quality equipment and supplies, and promoting open communication to reduce turnover. The Indian pharma sector has taken several proactive steps to combat the talent gap and address attrition. The Indian Pharmaceutical Association (IPA) has collaborated with educational institutions to develop curricula that meet industry requirements effectively. Sun Pharmaceutical Industries established dedicated research and development centres to promote innovation and attract skilled researchers. Also, companies like Reliance Life Sciences,  Serum Institute of India, Dr. Reddy’s Laboratories, Biocon and Cipla offer competitive salaries and appealing career opportunities, making them desirable workplaces for skilled professionals. Pharma Patashala, a pharma skills development centre, by Granules India, is addressing the skill deficit in pharmaceutical manufacturing. The programme provides training to selected candidates, creating a talent pipeline for the industry. Organisations must prioritise employee-friendly measures. Flexible work arrangements, such as remote work options and flexible hours, can foster a healthy work-life balance. Comprehensive health and wellness programmes and financial wellness initiatives can reinforce the organisation’s commitment to employee welfare.  Moreover, providing clear career growth paths, mentorship programmes, and opportunities for skill development can enhance employee engagement and retention. Sanjiv Das (sanjiv.das@mmactiv.com) ]]> <![CDATA[Serum Institute of India to launch dengue cure in 1 year]]> https://biospectrumindia.com/news/95/23538/serum-institute-of-india-to-launch-dengue-cure-in-1-year.html https://biospectrumindia.com/news/95/23538/serum-institute-of-india-to-launch-dengue-cure-in-1-year.html Thu, 31 Aug 2023 00:00:00 +0530 During a media interaction in Pune on 30 August, Cyrus S. Poonawalla, Chairman and Managing Director of Serum Institute of India, said that the company plans to develop dengue cure in approximately 1 year time as the disease is spreading rapidly in India as well as worldwide. He also said, "After Covishield's success, first time in the world we will be launching malaria vaccine which is desperately needed in the African countries and also in the endemic disease areas of India where hundreds of millions of people are getting affected with malaria." An insight on this development was earlier shared by Adar Poonawalla, Chief Executive Officer, Serum Institute of India, while speaking with BioSpectrum, that the dengue vaccine in the pipeline is in partnership with the National Institutes of Health (NIH) in the US for which the company is doing a lot of development work in India. Likewise, the process for the malaria vaccine development has also been done in India. In addition, the company will soon be launching its Human papillomavirus (HPV) vaccine. ]]> <![CDATA[Collaboration between industry and academia is required to address the current challenges of malaria, TB, dengue and RSV: Dr N K Arora]]> https://biospectrumindia.com/news/95/23498/collaboration-between-industry-and-academia-is-required-to-address-the-current-challenges-of-malaria-tb-dengue-and-rsv-dr-n-k-arora.html https://biospectrumindia.com/news/95/23498/collaboration-between-industry-and-academia-is-required-to-address-the-current-challenges-of-malaria-tb-dengue-and-rsv-dr-n-k-arora.html Sat, 26 Aug 2023 00:00:00 +0530 At the 2nd edition of the India Vaccine Leaders Conclave (IVLC), Dr N K Arora, Co-Chair, Covid Vaccine Candidate Advisory Committee, Department of Biotechnology (DBT) and Executive Director, INCLEN Trust, stated, "The last three years have clearly shown that the government is ready to invest catalytic funds for R&D for vaccine development. It has supported all vaccine candidate platforms in the country like mRNA, DNA, inactivated and protein sub-unit, among others, and is ready to provide support for R&D provided both the leadership from the industry and academia collaborate in an effective way". The two-day conclave commenced on August 22  under the theme 'Building Resilient Vaccine Ecosystems' in Mumbai. Highlighting the need for continuous global disease surveillance, he added that collaboration between industry and academia at national and international level is required to address the current challenges in the form of diseases like malaria, TB, dengue and respiratory syncytial virus (RSV). The event, which brought together leading experts from around the world, was aimed at showcasing how vaccination plays a crucial role in improving global health throughout all stages of life. The event featured keynote sessions, plenary talks and poster presentations and provided an excellent platform for networking opportunities with industry peers. The event was organised by BlueTech Media. Ashish Chauhan, Director, BlueTech Media, conducted the proceedings during the event. It was recommended that in order to implement life course vaccination, developing and drafting a road map or the policy and strategy should be initiated with private-public sector intervention.There is a need to ensure vaccine security and be future-ready for adult vaccination. Initiatives should be taken to educate public healthcare providers and members of professional associations and medical bodies for advocacy about currently available vaccines for adult age groups. This can help people to make an informed choice and healthcare providers to share information with citizens. A panel discussion was hosted on exploring global partnership in vaccine development which was moderated by Dr Kavita Singh , MD, South Asia Drugs for Neglected Disease Initiative (Advisory Board). Panelists included Dr Raj K Shirumalla, Mission Director, National Biopharma Mission BIRAC; Nitin Jain Sr General Manager & Divisional Head Zydus Life Sciences; Dr Ramesh Matur Sr VP, R&D, Biological E Limited; Dr Ashish Sahai, Additional Director, Serum Institute of India and Dr Tathagata Mukherjee, General Manager, Gennova Biopharmaceuticals. There was a presentation on Aseptic Operations in Vaccine Manufacturing by Dr Ashish Sahai, Additional Director, Serum Institute of India (SII), a presentation on Considerations for Single use Bioreactors in Vaccine Manufacturing by Manish Pathani,  Application Specialist, Cytiva and a presentation on Journey of India’s First mRNA Platform by Dr Ajay Singh, Head, mRNA, Gennova Biopharmaceuticals and a presentation on Vaccine Landscape in India and Role of Life Course Immunisation in reducing vaccine-preventable disease by Nitin Jain, Senior General Manager, Zydus Life Sciences.    Bhagwati Prasad ]]> <![CDATA[Hetero Biopharma deploys Transcell-Quantiphi's digital animal replacement technology for drug development]]> https://biospectrumindia.com/news/95/23462/hetero-biopharma-deploys-transcell-quantiphis-digital-animal-replacement-technology-for-drug-development.html https://biospectrumindia.com/news/95/23462/hetero-biopharma-deploys-transcell-quantiphis-digital-animal-replacement-technology-for-drug-development.html Wed, 16 Aug 2023 00:00:00 +0530 Hyderabad-based Hetero Biopharma has embarked on a working relationship with Transcell and Quantiphi to explore the integration of the Digital Animal Replacement Technology (DART) into its operational processes. Transcell and US-based Quantiphi have collaboratively developed an innovative solution known as DART which harnesses human Microphysiological Systems and employs artificial intelligence (AI) and machine learning-powered digital prediction models. These models are integrated into modular assays that predict safety and efficacy concerns of pharmaceuticals and biopharmaceuticals intended for human use.  One standout aspect of DART is its seamless integration into existing workflows, enhancing end-user engagement. This empowers users to assess the safety and efficacy of their assets, providing human-relevant data even before clinical trials commence and sometimes during routine batch testing stage. Within the developmental cycle of biosimilars, a strategic approach involves a progressive evaluation of biosimilarity and efficacy equivalence. This includes the consideration of conducting animal studies when necessary and appropriate, based on remaining uncertainties. This approach aims to efficiently tailor study requirements. DART is one of the fascinating areas that the Hyderabad-based startup Transcell is working on with an aim to replace the need for live animal testing in parts of the drug and vaccine development and manufacturing process. The US FDA Modernization Act 2.0 marks a pivotal moment in reshaping the global pharmaceutical and biopharmaceutical industry. Additionally, the Drugs Controller General of India (DCGI) has granted authorisation for the use of alternative methods to animal testing, such as cell-based assays and computer models.  “We have started working with Hetero Biopharma’s young and dynamic leadership team in offering some of the non-animal DART residing modules for human cardiotoxicity and immunogenicity like key assessments. We are sure to add value in supporting their routine testing requirements within their processes and workflow – Advantage in adopting DART, which is anti-thesis to contract testing model”, says Dr S Dravida, Founder & CEO of Transcell group representing DART implementation opportunity.  Dr Bala Reddy, Director of Hetero Biopharma says “Evaluating the value of animal studies to support regulatory approval of biosimilars is becoming more and more important. In light of guidelines from various regulatory agencies that encourage alternative approaches to animal testing, innovative technologies like Transcell’s human Microphysiological Systems in combination with AI & ML-based in-silico modeling, provide opportunities to develop better and more predictive scientific tools to safeguard the environment and the health of both humans and animals.”   ]]> <![CDATA[Gennova Biopharma receives $3.6 M funding to develop mRNA vaccine technology against Disease X]]> https://biospectrumindia.com/news/95/23445/gennova-biopharma-receives-3-6-m-funding-to-develop-mrna-vaccine-technology-against-disease-x.html https://biospectrumindia.com/news/95/23445/gennova-biopharma-receives-3-6-m-funding-to-develop-mrna-vaccine-technology-against-disease-x.html Tue, 08 Aug 2023 00:00:00 +0530 Norway-based Coalition for Epidemic Preparedness Innovations (CEPI) and Pune-based Gennova Biopharmaceuticals have announced a new funding agreement to advance the development of their self-amplifying mRNA (saRNA) platform to develop vaccine candidates against unknown pathogenic threats, also referred to as Disease X. CEPI will provide up to $3.6 million to support the optimisation of the saRNA-platform technology, the production process, and yield. A vaccine candidate will then be produced against rabies virus, part of the Rhabdoviridae family of viruses, for preclinical studies. Testing the vaccine candidate against this known virus, with accepted correlates of protection, will help to assess the concepts behind this new technology. This funding forms part of CEPI’s programme to support novel RNA vaccine platform technologies for emerging and select endemic infectious diseases, which could offer substantial advantages over existing mRNA technologies, such as multivalency, improved immunogenicity, storage and stability, productivity, response time, and cost-of-goods. Gennova’s saRNA vaccine platform could form part of a group of RNA technologies that CEPI is supporting that could enable rapid responses to future epidemics and pandemic threats, potentially within 100 days of identification. Unique to the saRNA technology being developed by Gennova is the CLNE delivery system. Rather than encapsulating the fragile mRNA molecules in a fatty shell (ie, lipid nanoparticles), as is the case for many mRNA vaccines, the CLNE system attaches the RNA molecules to the surface of fatty 2 molecules (ie, a nanoemulsion). This approach makes the manufacturing of potential vaccine candidates readily scalable and easily transferable between manufacturers, if needed. ]]> <![CDATA[Bharat Serums and Vaccines takes initiative to ensure compliance in assisted reproduction methods]]> https://biospectrumindia.com/news/95/23393/bharat-serums-and-vaccines-takes-initiative-to-ensure-compliance-in-assisted-reproduction-methods.html https://biospectrumindia.com/news/95/23393/bharat-serums-and-vaccines-takes-initiative-to-ensure-compliance-in-assisted-reproduction-methods.html Tue, 25 Jul 2023 00:00:00 +0530 Mumbai-based biopharmaceutical firm Bharat Serums and Vaccines has roped in Bureau Veritas (India) Pvt. Ltd. (BVIL), a world leader in Audit and Certification Services - as part of the BSV ART Act Readiness Programme. This programme aims to assess 50+ IVF centres/clinics (in the first six months) and help them implement the requirements of the Assisted Reproductive Technology Regulations, 2021 (the ART Act),  driving them towards greater compliance. Through an intensive survey, BVIL, will assess and then certify these centres with a Platinum, Gold and Silver rating depending on their level of readiness, ahead of the final inspection by the State authorities. In accordance with the BSV ART Act, IVF centres/clinics need to be inspected by State Boards to be registered as Level 1 / Level 2 Clinics & Surrogacy Clinics. ‘The ART Act Readiness Assessment Programme of BSV’ assesses the current state of these centres against six critical parameters: infrastructure; people and competency management; communication; patient and process selection; data records and compliance monitoring and identifies the gaps/areas of improvement that the centres need to address to become a model-code as described in the Act.  Speaking on this Vishwanath Swarup, COO- Domestic Operations, BSV, said “The Assisted Reproductive Technology Regulations (ART), 2021 aims at the regulation and supervision of ART clinics and banks, to prevent misuse and ensure adherence to safe and ethical practice of ART services. On the occasion of World IVF Day (July 25), as responsible leaders in IVF treatment, we are delighted to announce a first-of-its-kind initiative from BSV - ‘The ART Act Readiness Assessment Programme’.  ]]> <![CDATA[Multivalent meningococcal meningitis vaccine from Serum Institute of India achieves WHO prequalification]]> https://biospectrumindia.com/news/95/23329/multivalent-meningococcal-meningitis-vaccine-from-serum-institute-of-india-achieves-who-prequalification.html https://biospectrumindia.com/news/95/23329/multivalent-meningococcal-meningitis-vaccine-from-serum-institute-of-india-achieves-who-prequalification.html Wed, 12 Jul 2023 00:00:00 +0530 MenFive®, the first conjugate vaccine to protect against the five predominant causes of meningococcal meningitis in Africa, has been prequalified by the World Health Organization (WHO). Developed through a 13-year collaboration between Serum Institute of India Pvt Ltd (SIIPL) and PATH, with crucial funding from the UK government’s Foreign, Commonwealth and Development Office, MenFive® protects against meningococcal serogroups A, C, W, Y, and X and is designed to eliminate annual meningitis outbreaks and epidemics in the African meningitis belt—a string of 26 countries from Senegal and The Gambia in the west to Ethiopia in the east. It is also the only vaccine that prevents meningitis caused by meningococcal group X, a pathogen increasingly implicated in meningitis outbreaks in Africa.  WHO prequalification was supported by extensive clinical studies in The Gambia, India, and Mali that demonstrated a high level of safety and immunogenicity. Importantly, prequalification allows MenFive® to be procured by United Nations agencies and Gavi, The Vaccine Alliance. Adar Poonawalla, CEO, Serum Institute of India, said, “MenFive® is a game-changer vaccine developed through a powerful 13-year collaboration between SIIPL, PATH, and vital support from the UK government, in the fight against meningococcal meningitis in Africa. As the first conjugate vaccine to safeguard against the five predominant causes of this deadly disease, MenFive® offers hope for a future free from annual outbreaks and epidemics in the African meningitis belt. It is a big moment as we, together, pave the way towards a healthier Africa, saving countless lives."  Meningococcal meningitis is a bacterial infection that sets in rapidly and can kill within hours. It can cause severe brain damage and sepsis leading to limb amputation and is fatal in 50 percent of cases if untreated. MenFive® is currently undergoing an additional Phase 3 study in healthy children between 9 and 15 months of age in Mali, to examine MenFive®’s safety and immunogenicity when administered alongside measles/rubella and yellow fever vaccine.   ]]> <![CDATA[Biocon Biologics expands footprint in emerging markets]]> https://biospectrumindia.com/news/95/23287/biocon-biologics-expands-footprint-in-emerging-markets.html https://biospectrumindia.com/news/95/23287/biocon-biologics-expands-footprint-in-emerging-markets.html Wed, 05 Jul 2023 00:00:00 +0530 Bengaluru-based Biocon Biologics has completed the integration of the acquired biosimilars business in over 70 countries in Emerging Markets effective July 1, 2023, increasing the scale and scope of its business. Following the deal closure in November 2022, this marks the first wave of countries where Viatris' operations have fully transitioned to Biocon Biologics. A robust integration plan has ensured a seamless transition of partners, people, systems, and processes across these countries. The existing commercialised portfolio of biosimilars, including bTrastuzumab, bPegfilgrastim, bBevacizumab, bGlargine, bAspart, bAdalimumab, and bEtanercept, managed by Viatris in these markets, is now a part of Biocon Biologics’ commercial organisation. The company will work with existing and new partners to expand its footprint and strengthen business presence in these countries. Its best-in-class R&D capabilities, high-quality manufacturing, supply chain excellence, and commercial and regulatory expertise will enable the company to expand access to a diverse portfolio of biosimilars, meet patients’ needs and be a trusted partner to patients and the healthcare community in these markets.  All the biosimilar products commercialised by Viatris in various markets such as bGlargine (Semglee), bPegfilgrastim (Fulphila), bTrastuzumab (Ogivri), bBevacizumab (Abevmy) and inlicensed product bAdalimumab (Hulio), will continue to serve patients’ needs. Most of these have been co-developed with Biocon Biologics and manufactured at its world class facilities in India and Malaysia. The diverse portfolio covers key therapeutic areas of cancer, diabetes and autoimmune disease.   ]]> <![CDATA[National Institute of Virology to engage with CEPI for standardising assessment of infectious disease vaccines]]> https://biospectrumindia.com/news/95/23184/national-institute-of-virology-to-engage-with-cepi-for-standardising-assessment-of-infectious-disease-vaccines.html https://biospectrumindia.com/news/95/23184/national-institute-of-virology-to-engage-with-cepi-for-standardising-assessment-of-infectious-disease-vaccines.html Tue, 06 Jun 2023 00:00:00 +0530 Norway-based Coalition for Epidemic Preparedness Innovations (CEPI) has significantly expanded the scale and geographical footprint of its epidemic and pandemic vaccine testing laboratory network in the Global South. CEPI has announced that an additional five members based in Africa and India have joined its Centralised Laboratory Network (CLN) which now has 15 partner facilities in 13 countries. The Indian Council of Medical Research- National Institute of Virology (ICMR NIV) from Pune is the new entrant in the list. Engagement of NIV with CEPI is intended to help in establishing validated assays and standards for expedited testing of new vaccines as per internationally accepted norms.  The CLN is the largest global group using the same methods and materials, like reagents—substances used to carry out a scientific test—to standardise and accelerate the evaluation of vaccines against epidemic and pandemic diseases. In the event of an outbreak of infectious disease, having an established global clinical laboratory network in place will facilitate faster data readouts by harmonizing analyses and reducing sample shipping times due to its worldwide footprint.  ]]> <![CDATA[Rakuten to begin Ph 3 clinical trial for treatment of recurrent head and neck cancer in India]]> https://biospectrumindia.com/news/95/23130/rakuten-to-begin-ph-3-clinical-trial-for-treatment-of-recurrent-head-and-neck-cancer-in-india.html https://biospectrumindia.com/news/95/23130/rakuten-to-begin-ph-3-clinical-trial-for-treatment-of-recurrent-head-and-neck-cancer-in-india.html Tue, 23 May 2023 00:00:00 +0530 US-headquartered Rakuten Medical, Inc. has been granted permission from the Central Drugs Standard Control Organisation (CDSCO) to conduct its global, pivotal Phase 3 clinical trial evaluating Alluminox treatment (photoimmunotherapy) using ASP-1929 in patients with locoregional, recurrent head and neck squamous cell carcinomas (HNSCC) in India, and the registration of clinical trial information with the Clinical Trial Registry of India (CTRI) has been completed. The study sites will include several leading medical institutions in India such as the Tata Memorial Centre and Narayana Health, and the treatment will be administered to enrolled patients once ready. This ASP-1929-301 study is currently underway in several countries such as the US and Taiwan, and will enroll 275 patients globally including Indian patients. In India, more than 200,000 new cases of head and neck cancer are diagnosed each year, which accounts for approximately 25% of all new head and neck cancer cases worldwide.  ASP-1929 is a conjugation of an antibody cetuximab and IRDye 700DX, a light activatable dye, and is Rakuten Medical’s first pipeline drug developed on its Alluminox platform.  The US Food and Drug Administration (FDA) has granted Fast Track designation for the drug in January 2018. In Japan, in September 2020, ASP-1929 received marketing approval from the Ministry of Health, Labour and Welfare for unresectable locally advanced or recurrent head and neck cancer as brand name Akalux, together with BioBlade Laser System, the medical device used in combination with the drug under the Conditional Early Approval System. Outside of Japan, ASP-1929 and the laser device system have not yet been approved by any regulatory authority.     ]]> <![CDATA[World’s first and only oral cholera vaccine in LDPE unidose pack launches in India]]> https://biospectrumindia.com/news/95/23077/worlds-first-and-only-oral-cholera-vaccine-in-ldpe-unidose-pack-launches-in-india.html https://biospectrumindia.com/news/95/23077/worlds-first-and-only-oral-cholera-vaccine-in-ldpe-unidose-pack-launches-in-india.html Fri, 12 May 2023 00:00:00 +0530 Mumbai-based startup TechInvention Lifecare has partnered with Eubiologics Co. in  South Korea,  to  launch Euvichol-Plus,  the  world’s  first  and  only  oral  cholera vaccine (OCV), in a low-density polyethylene (LDPE) unidose pack in India. The LDPE unidose pack of Euvichol-Plus is not only easy and safe to use, but it also reduces the issues pertaining  to  conventional  glass  vials  in  terms  of  breakage,  storage,  transportation,  distribution,  waste management, and facilitates delivery in emergency situations and humanitarian crises in campaign mode. TechInvention recently received approval by the regulatory body Central Drugs Standard Control Organisation (CDSCO) for the launch of Euvichol-Plus following the completion of a phase III clinical study. While cholera remains a major global public health threat, there has been an alarming resurgence of cases in susceptible countries globally amidst the stoppage in production of one of the only two cholera vaccines. India features at the top of the list of cholera- endemic countries, with an estimated incidence rate of 1.64 per 1,000 people. In India, estimates show that 400 million people are at risk of cholera, with an estimated 6,751,888 cases and 20,256 (3%) deaths annually.  TechInvention's Founder and CEO, Syed Ahmed said, "We wish to contribute to the national initiatives along the lines of WHO's ‘Ending Cholera: A Global Roadmap by  2030’.  TechInvention has  2 more  vaccines in late-stage clinical development and regulatory approval in India, while there are more on the anvil." ]]> <![CDATA[AstraZeneca to set up five CoEs for severe asthma across India ]]> https://biospectrumindia.com/news/95/23042/astrazeneca-to-set-up-five-coes-for-severe-asthma-across-india-.html https://biospectrumindia.com/news/95/23042/astrazeneca-to-set-up-five-coes-for-severe-asthma-across-india-.html Tue, 02 May 2023 00:00:00 +0530 AstraZeneca India has announced plans to launch five Centres of Excellences (CoEs) across New Delhi, Ahmedabad, Goa and Cochin to provide a systematic approach to standardised and uniform management of patients with severe asthma. The centres will serve as the exemplar hub for treatment and management of severe asthma patients, and they will, in turn guide and support evolving severe asthma centres for a systematic and guidelines-based approach to identify and treat severe asthma patients. The Centres of Excellence (CoEs) for severe asthma, as per the guidelines established by the Global Initiative for Asthma (GINA), would concentrate on specialty and clinical assessment, diagnosis, patient counselling, biologics initiation, and data management related to severe asthma. The management of severe asthma requires continued research, education, and support to patients. Appropriate patient selection is critical for the application of biologics or advanced precision therapy for severe asthma. Under AstraZeneca’s model of Severe Asthma CoEs, disease management is centred on four crucial pillars. The first involves utilising a standardised proforma to identify the appropriate patient profile for severe asthma. The second pillar involves bridging gaps in patient awareness by providing education on severe asthma through interactive patient modules, websites, and booklets. The third pillar focuses on providing a specialised curriculum for aspiring respiratory specialists to assist them in identifying the appropriate patients and guiding them towards the most suitable therapy options. Finally, develop an academy for asthma counsellors to help them evaluate patient care techniques, adherence, and asthma control.   ]]> <![CDATA[GSK introduces shingles vaccine Shingrix in India]]> https://biospectrumindia.com/news/95/22997/gsk-introduces-shingles-vaccine-shingrix-in-india.html https://biospectrumindia.com/news/95/22997/gsk-introduces-shingles-vaccine-shingrix-in-india.html Mon, 24 Apr 2023 00:00:00 +0530 British firm GlaxoSmithKline (GSK) Pharmaceuticals has announced the launch of Shingrix (Zoster Vaccine Recombinant, Adjuvanted) in India, for the prevention of shingles (herpes zoster) and post-herpetic neuralgia in adults aged 50 years and above. Shingrix is the world’s first non-live, recombinant subunit vaccine to be given intramuscularly in two doses. Shingles is caused by the reactivation of the varicella zoster virus (VZV), the same virus that causes chickenpox. A seroprevalence study in Indian subjects showed that by the age of 40 years more than 90% had this virus in their body and were vulnerable to shingles. Shingles causes a painful rash. In all cases, the rash disappears, but in a large number of cases, the pain persists for months or years. This pain is known as post-herpetic neuralgia (PHN). Shingrix was approved by the US Food and Drug Administration (FDA) for the prevention of shingles in adults 50 years of age or older in 2017.The European Commission gave Shingrix approval for the prevention of shingles in adults 50 years of age or older in 2018.   ]]> <![CDATA[Malaria vaccine manufactured by Serum Institute of India receives clearance in Ghana]]> https://biospectrumindia.com/news/95/22951/malaria-vaccine-manufactured-by-serum-institute-of-india-receives-clearance-in-ghana.html https://biospectrumindia.com/news/95/22951/malaria-vaccine-manufactured-by-serum-institute-of-india-receives-clearance-in-ghana.html Fri, 14 Apr 2023 00:00:00 +0530 The University of Oxford-developed and Serum Institute of India (SII) manufactured and scaled up R21/Matrix-M malaria vaccine, leveraging Novavax’s adjuvant technology, has been licensed for use in Ghana by the country’s Food and Drugs Authority (FDA). This marks the first regulatory clearance for the R21/Matrix-M malaria vaccine for use in any country. The successful registration was notified to SII by the FDA Ghana. SII is the manufacturing and commercialisation license holder for the vaccine. The vaccine has been approved for use in children aged 5 to 36 months, the age group at highest risk of death from malaria. It is hoped that this first crucial step will enable the vaccine to help Ghanaian and African children to effectively combat malaria. The R21/Matrix-M vaccine has demonstrated high levels of efficacy and safety in Phase II trials, including amongst children who received a booster dose of R21/Matrix-M at one year following a primary three-dose regime. Adar Poonawalla, CEO, Serum Institute of India, said, "The licensure of the R21/Matrix-M Malaria Vaccine for use in Ghana is a significant milestone in our efforts to combat malaria around the world. We remain steadfast in our commitment to scaling up production of the vaccine to meet the needs of countries with high malaria burden and to support global efforts towards saving lives." ]]> <![CDATA["Scientifically a nasal vaccine is much more effective than an injectable one"]]> https://biospectrumindia.com/interviews/95/22917/scientifically-a-nasal-vaccine-is-much-more-effective-than-an-injectable-one.html https://biospectrumindia.com/interviews/95/22917/scientifically-a-nasal-vaccine-is-much-more-effective-than-an-injectable-one.html Tue, 11 Apr 2023 17:00:00 +0530 The industry is now shifting gears from vaccine manufacturing to vaccine R&D in India. How is Serum Institute leveraging this opportunity? What new launches are in the pipeline? Traditionally the Indian vaccine industry has been mainly manufacturing but now we are seeing that certain companies are developing or co-developing their own vaccines which involves a lot of clinical trials expense and detailed work which takes at least 4 to 5 years. For example, our HPV vaccine which we are planning to launch soon, along with our malaria vaccine. We have developed the process for both these vaccines in India. The malaria vaccine is particularly for the African continent because it deals with the falciparum parasite, not the other one which is found in India which we would work upon after a couple of years. Then, we also have our dengue vaccine in the pipeline in partnership with the National Institutes of Health (NIH) in the US for which we are doing a lot of the development work in India. We also have our pneumococcal vaccine which we developed with NIH and we got our own patents for it. It is a ten-valent pneumonia vaccine for children since this disease is a major killer in children below the age of 5, and we are planning to make a higher valency of this vaccine i.e. 20 or 21.   The company had expanded its facilities for COVID-19 vaccine production. But now that the pandemic period is over, how do you plan to utilise that space for your new products? Due to COVID-19, we had increased our capacity from 1.5 billion to 4 billion doses. So now we have a lot of idle capacity lying around which we just have to rejig, to be able to handle this situation. In fact, the space would be under utilised by a factor of almost 50 per cent. Even with the launch of our new vaccines, it will take time to further utilise this space. We have spent more than Rs 11,000 crore in the last two years in building capacity, and we have spent another Rs 10,000 crore over the last five years in other activities such as developing our new campus which is about 45-50 acres. So, we have been investing in setting up new equipment and other manufacturing purposes. We have also invested in partnership with Aspen, to have a hold and right to use facilities in South Africa to make some vaccines in Africa. We have also got a tie up in the UK with Oxford Biomedica to make up to 100-150 million doses there. So, we do not know what we are going to do with this space at the moment, as it is available. In addition, we have a plant in Europe. In different geographies, about 5-10 per cent of our capacity has been spread out, outside of India and 90 per cent is in India.   What are the company’s revenue projections for FY 22-23? Now that the COVID-19 sales have come down, we will be close to around $1 billion. During the COVID-19 period, we generated around $4 billion. So, this year, the non-COVID sales is around $900 million, and with these new launches coming up, we hope to add around $100 million with each vaccine to begin with. We hope to cross $1 billion in the non-COVID vaccine revenue.   Is the company exploring new technologies for developing new vaccine products?  Yes, we are exploring some new areas of technology. Traditionally, it has been viral vectors or sub unit protein vaccines or live attenuated vaccines which have proven to be safe. We are now exploring CRISPR technology for HIV vaccine development. It is an early stage of phase 1 in the US. If it works out well in phase 2 and 3, we might have something that does not fully take care of HIV from one’s system but does quite substantially. We are waiting to see how it works out in a larger study. Then, there is the mRNA technology for vaccine development which we are exploring in partnership with US-based GreenLight Biosciences. But, we still have to decide for which disease we should use the mRNA technology. Although mRNA as a therapeutic technology has been previously used for cancer, it has not been proven to be a stable option for vaccine development. Vaccines need to be stable for a period of two years in terms of shelf life. So, this area needs improvement.  Besides these two technologies, we are also developing hepatitis B vaccine in the patch format. But the patch technology also has limitations since it is difficult to figure out the actual dose that needs to be incorporated. It also requires a transformation in the way we manufacture vaccines. It requires bulk of the vaccines to be absorbed on patches. We would have to invest in new filling lines. So, technologies like patch or nasal might only be applicable to a few vaccines. But of course, scientifically a nasal vaccine is much more effective than an injectable one.   Serum Institute has forayed into the diagnostic testing space by investing in Pune-based Mylab Discovery Solutions? How do you plan to explore this space further? Diagnostics has always been a weak spot where India has not been able to reach out quickly with accessibility and affordability. So, we are developing a lot of tests which were unavailable earlier. Also, most of the diagnostic tests require the presence of laboratories. Mylab is not only making a lot of kits, but also many compact machines which can be operated with 3-4 people and does not really require a full laboratory to perform the tests. With these machines, we are hoping to transform and change the way diagnostic tests are traditionally done. For instance, with these machines you can get the test results of an RT-PCR test in 2-3 hours. Hospitals and diagnostic service providers can simply buy such machines and perform multiple tests. And now we are developing diagnostic tests for a number of diseases, such as sexually transmitted diseases, HIV, HPV, and much more. Mylab has already become the largest RT-PCR and rapid antigen tests kit manufacturer in India. Simultaneously, we are also looking at bringing  these Indian diagnostic tests onto the global market. We have been accredited by the European authorities and will be exporting these diagnostic kits very soon.   What role are you playing for enhancing tuberculosis (TB) diagnosis and elimination in India? We have developed a Cy-Tb kit which helps detect latent TB with ease and accuracy. We also have our recombinant BCG vaccine which would be far more effective. We should launch that very soon. We hope to make a good headway in fighting TB this way.   Dr Manbeena Chawla (manbeena.chawla@mmactiv.com) ]]> <![CDATA[Serum Institute of India continues to lead the Indian Biopharmaceutical Industry Survey 2022]]> https://biospectrumindia.com/features/95/22925/serum-institute-of-india-continues-to-lead-the-indian-biopharmaceutical-industry-survey-2022.html https://biospectrumindia.com/features/95/22925/serum-institute-of-india-continues-to-lead-the-indian-biopharmaceutical-industry-survey-2022.html Tue, 11 Apr 2023 00:00:00 +0530 Pune-based Serum Institute of India continues to lead the Indian biopharmaceutical industry with a revenue of Rs 25000 crore for the year 2021-22 as against Rs 7201 crore for the year 2020-21 followed by Hyderabad-based Bharat Biotech International with revenue of Rs 8352 crore registering a 480 per cent growth over last year at No 2 position and Bengaluru-based Biocon with Rs 5805 crore with a growth of 12 per cent at No 3 position.       BIOSPECTRUM BIOPHARMA SURVEY AND METHODOLOGY BioSpectrum India, a leading B2B media platform in Lifesciences space since 2003, re-launched its ranking special edition in June 2019 after a gap of 2 years.  In this survey we looked at only the Biopharma Industry with companies specialising in Biologics/Blood products/ Recombinant products/ mAbs/ Vaccines/ Insulin.  We have highlighted the companies (both MNCs and domestic players) based on their achievements in the past financial years. A detailed questionnaire (survey form) was sent to the companies in biologicals space to capture the needed information for the analysis. This was done during January to March 2023 (Sales revenues of all the companies are in Rs Crore). Companies shared information with us to the extent it was possible by them. We have collected information about listed companies from stock exchange, financial agencies and speaking with industry experts and Ministry of Corporate Affairs (MCA) as well. The revenues considered for the analysis are biologicals sales and service figures. In several cases, where revenue figures were not available, estimates were arrived at in discussion with industry experts. For all the ranking purposes, we have taken the biopharma business only into consideration. Wherever Revenue is mentioned, it means sales turnover from the biopharma division. Therefore, revenue wherever mentioned is not necessarily the total sales turnover of the company.    * We have not covered some of the Biopharma companies as they are unable to participate in the BioSpectrum Survey 2021-22   Click here for the survey results of the BioServices Industry for FY 21-22 ]]> <![CDATA[Gennova Biopharma seeks EUA for first needle-free mRNA vaccine as omicron booster]]> https://biospectrumindia.com/news/95/22891/gennova-biopharma-seeks-eua-for-first-needle-free-mrna-vaccine-as-omicron-booster.html https://biospectrumindia.com/news/95/22891/gennova-biopharma-seeks-eua-for-first-needle-free-mrna-vaccine-as-omicron-booster.html Mon, 03 Apr 2023 00:00:00 +0530 Following assessment of the primary endpoints of the Phase II/III study, Pune-based Gennova Biopharmaceuticals (in partnership with US-based PharmaJet) has submitted data for its mRNA-based Omicron specific COVID-19 booster shot for Emergency Use Authorisation (EUA) to the office of the Drug Controller General of India (DCGI). The submission corresponds with an increase in COVID-19 cases in India and is the first booster in India targeted specifically for the Omicron variant. The vaccine, GEMCOVAC-OM, will be delivered exclusively with the PharmaJet Tropis Precision Delivery System (PDS). GEMCOVAC-OM is a lyophilised vaccine, stable at 2-8 °C, which means it can be distributed through the existing refrigeration supply chain Pan-India and in low- and middle-income countries (LMICs). Unlike other approved mRNA vaccines, it does not require ultra-low temperature storage conditions. GEMCOVAC-OM was assessed for its safety and immunogenicity when administered as a booster in participants who have received two doses of COVISHIELD and COVAXIN, the two main COVID-19 vaccines used in India. The vaccine is delivered needle-free, intradermally with the PharmaJet Tropis Precision Delivery System which has been shown to reliably enhance nucleic acid vaccine immune response. ]]> <![CDATA[13th Edition of Vaccines World Summit 2023 discusses India’s way forward for vaccine development]]> https://biospectrumindia.com/features/95/22879/13th-edition-of-vaccines-world-summit-2023-discusses-indias-way-forward-for-vaccine-development.html https://biospectrumindia.com/features/95/22879/13th-edition-of-vaccines-world-summit-2023-discusses-indias-way-forward-for-vaccine-development.html Fri, 31 Mar 2023 00:00:00 +0530 The 13th edition of Vaccines World Summit and 2nd Annual Biologics Festival India 2023 was held in Pune between 27th and 30th March 2023, and was organised by IMAPAC. Leaders in manufacturing, R&D and supply chain from vaccine manufacturing companies came together to debate on the best practices in vaccine manufacturing in India and share intelligence and network. Ranjan Chakrabarti, Former Vice President and Global Biologics, United States Pharmacopeia, India gave the opening address. He provided insights on “Indian Biologics- Present and Future” and shared his thoughts on how to address the challenges faced by the Indian biotech industry. This was followed by a leadership panel discussion on exploring partnerships in developing and manufacturing vaccines in the international sector. The panel held discussions on challenges for vaccine development, lessons learnt from the pandemic for vaccine development and creating vaccine equity. During the panel dicussion, Rajinder Suri, CEO, Developing Countries Vaccine Manufacturers Network opined on pandemic preparedness and response, challenges and opportunities in developing countries, and emphasised on how public private partenrships (PPPs) can encourage R&D in vaccine manufacturing.  Further, Arani Chatterjee, Joint President, Cadila Pharmaceuticals divulged in detail the advancements in clinical trials for infectious diseases like malaria, pneumonia, meningitis, TB vaccines and novel tetravalent dengue vaccines. He emphasised on policy actions that will be able to stimulate investments in vaccine R&D and promote regional cooperation. During another session at the Summit, Sarah McMullen. Country Director, US FDA – India Office along with Preetha Rajaraman, Regional Representative for South Asia in the Office of Global Affairs/Office of the Secretary, Department of Health and Human Services gave an overview of US India collaboration on vaccines and opined about the regulatory challenges faced by vaccine manufacturers.    New approaches of vaccine development A key element of the Summit was the deliberations held on embracing newer approaches to develop vaccines, particulalrly with the rise of emerging infectious diseases across the globe. Sanjay Singh, CEO, Gennova Biopharmaceuticals gave a speech on how mRNA vaccines are revolutionising the vaccine space. He also mentioned about how the company is working on triple-negative breast cancer vaccine along with its work with Tata Memorial Centre in Kolkata. He spoke about the advantages of the mRNA platform, challenges of democratisation of platform technology, mRNA degradation and lastly emphasised speed which is important in today’s life. Puneet Kalra, Therapy Lead, Takeda South Asia talked about the future directions to vaccine development and a newer understanding of protective immunity with difficult-to-target pathogens and antigenic variations.  Adding another perspective, Vickram Srivastava, Head Planning-Global Supply Chain, Sun Pharma gave an overview on the supply chain impact, challenges in the vaccine/biopharma supply chain, risk mitigation strategies to build resilience, innovation in supply chain and logistics etc. The Summit also saw interesting observations being shared by Swapan Kumar Jana, Director, R&D and manufacturing, Serum Institute of India talking about data-driven decision-making in complex vaccine process development and manufacturing. Rajendar Burki, AVP-Research and Development, Biological E provided inputs on analytical and biophysical methods that can be used to characterise biopharmaceuticals and vaccines. He mentioned about antibody-based immunoassays that offer individual antigen quantification in combination/multivalent vaccines.   More discussions were also held towards the development of nano vaccines and oral vaccines platforms.   From the Academia  The industry experts were joined by a panel of scientists from the academic sector to share their perspective of new research areas of vaccine development in India. Dr Nimesh Gupta, Chief Vaccine Immunology Laboratory, National Institute of Immunology, gave a glimpse of how to deploy immunology for developing highly effective, durable immunity and protective vaccines. He also mentioned how vaccine candidates must be designed and tested based on multi-dimensional mediators of protection. Gupta emphasised on academia-industry partnership for vaccine development, on how investment in disruptive innovations can overcome the current challenges in developing potent cost-effective vaccines in a short duration and the development of challenging human infection models for vaccine design and efficacy assessment. Adding on, Dr Ravi PN Mishra, Principal Scientist & Group Leader, CSIR-Institute of Microbial Technology, talked about reverse vaccinology. He mentioned about the rational design and development of recombinant vaccines against bacterial and viral pathogens. Besides these interesting discussions, fireside chats on IT innovations in warehousing and materials management were also conducted during the Summit, making it an impactful and successful event.   Image caption- (L-R) Sanjay Singh, CEO, Gennova Biopharmaceuticals; Rajinder Suri, CEO, Developing Countries Vaccine Manufacturers Network; Rajendar Burki, AVP-Research and Development, Biological E and Arani Chatterjee, Joint President, Cadila Pharmaceuticals during the panel discussion at the Summit.     Sanjiv Das (sanjiv.das@mmactiv.com)  ]]> <![CDATA[Cadila Pharma's novel three-dose rabies vaccine ThRabis under trial for use in children]]> https://biospectrumindia.com/news/95/22865/cadila-pharmas-novel-three-dose-rabies-vaccine-thrabis-under-trial-for-use-in-children.html https://biospectrumindia.com/news/95/22865/cadila-pharmas-novel-three-dose-rabies-vaccine-thrabis-under-trial-for-use-in-children.html Tue, 28 Mar 2023 00:00:00 +0530 Ahmedabad-based pharma major Cadila Pharmaceuticals had announced the launch of its novel three-dose recombinant nano-particle based rabies G protein vaccine last year, for adults. The vaccine ThRabis, prepared by using Virus-Like Particle technology (VLP), is now undergoing clinical trials for use in children and shall be launched in the market very soon. During an interaction with BioSpectrum, Dr Arani Chatterjee, Joint President, Cadila Pharma said, "Cadila is the first company in the world to develop a three-dose rabies vaccine in comparison to all the other vaccines which have five doses. This is a big matter of compliance for the patients. Currently, trials are going on for children for this vaccine which is already approved in adults." Besides being convenient, ThRabis is an intramuscular vaccine and less painful for the recipients. It is also extremely convenient for doctors as it is a ready to use vaccine  and does not require  reconstitution prior to use ]]> <![CDATA[Sanofi receives marketing approval for diabetes drug Soliqua in India]]> https://biospectrumindia.com/news/95/22857/sanofi-receives-marketing-approval-for-diabetes-drug-soliqua-in-india.html https://biospectrumindia.com/news/95/22857/sanofi-receives-marketing-approval-for-diabetes-drug-soliqua-in-india.html Mon, 27 Mar 2023 00:00:00 +0530 Sanofi (India) has received marketing authorisation for its diabetes drug Soliqua (in pre-filled pen) from the Central Drugs Standard Control Organisation (CDSCO). Soliqua is indicated as treatment to improve glycemic control as an adjunct to diet and exercise, in adults with obesity and type 2 diabetes who are insufficiently controlled on oral or injectable therapies. It comes in once daily dosing of pre-filled pens in fixed-ratio combination (10-40 and 30-60) of insulin glargine and lixisenatide. Soliqua (10-40 and 30-60 prefilled pens) is a once-daily injectable combination drug containing insulin glargine 100 Units/ml, which is a long-acting basal insulin and lixisenatide, a GLP-1 receptor agonist. According to Dr Shalini Menon, Country Medical Lead, Sanofi (India), “Concerns about hypoglycemia and weight gain are known barriers when advancing diabetes treatments, more so when intensifying to a complex insulin regime. The global Solimix study that included Indian patients, demonstrated that once daily Soliqua provides with weight benefit and less hypoglycaemia when compared with twice daily premixed insulin – thereby becoming a valuable option for endocrinologists.”   ]]> <![CDATA[Indian Immunologicals signs MoU with ICAR-CIFA for fish vaccine development]]> https://biospectrumindia.com/news/95/22787/indian-immunologicals-signs-mou-with-icar-cifa-for-fish-vaccine-development.html https://biospectrumindia.com/news/95/22787/indian-immunologicals-signs-mou-with-icar-cifa-for-fish-vaccine-development.html Mon, 13 Mar 2023 00:00:00 +0530 Hyderabad-based Indian Immunologicals Limited (IIL) has announced partnership with Central Institute of Freshwater Aquaculture (CIFA), Bhubaneswar, an Indian Council of Agricultural Research (ICAR) Institute for the commercial development of vaccine against Hemorrhagic Septicemia, also called Aeromonas Septicemia, Ulcer Disease or Red-Sore Disease in freshwater fish. IIL ventured into aqua business in October 2022 by launching products for aquaculture health market dealing with pond management and fish or shrimp gut management and subsequently announced commercial development of fish vaccines with ICAR-Central Institute of Fisheries Education (CIFE). Hemorrhagic Septicemia in freshwater fishes is caused by Aeromonas hydrophila, an opportunistic pathogenic bacterium. This infection is the scourge of fresh and brackish water fish farming worldwide and is considered as a significant economic problem in Indian aquaculture over the past decades. All the cultured freshwater fish species in India like rohu, catla, mrigal, silver carp, grass carp, common carp, medium carps, channel catfish, eel, etc. are susceptible to this disease. Over the years, antibiotics and chemotherapeutants are used for controlling bacterial diseases including A. hydrophila. Now bacterial pathogens have become resistant to these chemicals, when used over an extended period and some chemicals pose environmental health hazards. In this context, vaccination is the most promising and environmentally safe concept for controlling diseases. Speaking on the occasion, Dr K Anand Kumar, Managing Director, Indian Immunologicals Limited said, “We are working at multiple-fronts in defining pathways for commercial development of fish vaccines in India". ]]> <![CDATA[India’s vaccine supremacy]]> https://biospectrumindia.com/features/95/22712/indias-vaccine-supremacy.html https://biospectrumindia.com/features/95/22712/indias-vaccine-supremacy.html Wed, 01 Mar 2023 00:00:00 +0530 India has been at the forefront of vaccine research and manufacturing in the world. During  COVID-19, companies such as Serum Institute of India and Bharat Biotech, among others, were able to come up with vaccines that proved to be game changers in India’s healthcare system. Meeting over 60 per cent of the world’s demand and supplying over 2.4 billion doses of COVID-19 vaccines and having a repository of over 50 indigenous vaccines, India’s vaccine story is truly remarkable.  Dr Mansukh Mandaviya, Union Minister for Health & Family Welfare and Chemicals & Fertilisers, Government of India, during an event in Pune last year, said that India had supplied vaccines to 100 countries and provided drugs to 150 countries during COVID-19. He added, “As we go forward, there is an urgent need for strengthening private-public sector partnerships across the vaccine manufacturing value chain.”    The Indian Vaccine Saga: 1978-2023   In the 19th century, efforts were made to replace variolation (a method of inoculation first used to immunise individuals against smallpox with material taken from a patient or a recently variolated individual) with vaccination, setting up vaccine institutes, trials of cholera vaccine and the discovery of the plague vaccine. The early 20th century saw the setting up of more vaccine institutes and the challenges associated with the expansion of smallpox vaccination and typhoid vaccine trials. The post-independence era saw private players enter the arena. India saw the launch of the Expanded Programme for Immunisation in 1978 and Universal Immunisation Programme in 1985. It may be noted that till 1850 India used to import vaccines from Britain. Logistical issues and an increase in demand prompted the establishment of research institutes and manufacturing facilities in the country. During the early 19th century, some research activities were conducted in Bombay (now Mumbai) and animal experiments for lymph were conducted in Madras (now Chennai). The outbreak of cholera in Bengal prompted Dr Waldemar Haffkine, a Ukrainian-French bacteriologist known for his pioneering work in vaccines, to visit India and conduct trials in Agra where its efficacy was proven. In 1896, plague broke out in India which prompted Dr Haffkine to conduct research at a two-room set up in Grant Road, Mumbai, that led to the development of the first vaccine in India. In 1899, the laboratory was known as Plague Laboratory, renamed in 1905 as Bombay Bacteriological Laboratory and renamed the Haffkine Institute in 1925. In the early 20th century, India had four vaccines namely for cholera, smallpox, plague and typhoid. Pasteur Institute of India, Coonoor, is one of the pioneer institutes in India in the production of Anti Rabies Vaccine (dog bite vaccine) and DPT vaccine (triple antigen against diphtheria, pertussis and tetanus) for the Expanded Programme of Immunisation of the Government of India. This institute started functioning as Pasteur Institute of Southern India on April 6, 1907 and was officially opened by Sir Arthur Lawley, Governor of Madras, on April 25, 1907. Later, on May 1, 1948, the BCG Vaccine Laboratory was established in Chennai and is now working under the Ministry of Health and Family Welfare of the Government of India. The laboratory manufactures freeze-dried BCG vaccines for the control of childhood tuberculosis and tuberculous meningitis in children and supplies to the Expanded Programme of Immunisation (EPI) of the Government of India and other needy medical faculties/ hospitals.   Enter Serum Institute  India saw a revolution in vaccine manufacturing with Dr Cyrus Poonawalla founding the Serum Institute of India (SII) in 1966 to manufacture life-saving immuno-biologicals. India which was facing a vaccine shortage in the country and used to import at high prices saw several life-saving biologicals being manufactured at prices affordable to the common man and in abundance. India became self-sufficient in Tetanus Anti-toxin and Anti-snake Venom serum, followed by the DTP  group of vaccines and then later on MMR (Measles, Mumps and Rubella) group of vaccines. Today, the company has more than four indigenously manufactured vaccines. During the same time, Bharat Immunologicals and Biologicals Corporation (BIBCOL), a Government of India undertaking, started manufacturing oral polio vaccines in bulk in 1966. Hyderabad-based Dano Vaccines & Biologicals introduced Tetanus Vaccine – DanoTT in 1985.  Shantha Biotechnics launched the Hepatitis B vaccine, Shanvac-B, the first recombinant health product in India. Founded by Dr K I Varaprasad Reddy in 1993, Shantha was one of the first Indian biotechs to create a recombinant product, obtaining World Health Organisation (WHO) prequalification for its Hepatitis B vaccine in 2002. During the same year, Bharat Biotech International Ltd (BBIL) started its operations with Dr Krishna M Ella and Suchitra Ella returning from the US to set up a company dedicated to creating innovative vaccines and bio-therapeutics. Revac-B, an indigenously made genetically-engineered vaccine for Hepatitis-B, was launched in Hyderabad by Bharat Biotech International in 1998. Revac-B was marketed by Ahmedabad-based Intas Pharmaceuticals.  In the same year, Ghaziabad-based BiO-Med unveiled Typhoid Polysaccharide Vaccine, the first indigenously manufactured Vi antigen typhoid vaccine. It was manufactured as per Indian Pharmacopoeia.     Human Biologicals Institute (HBI), a division of Indian Immunologicals Limited (IIL), rolled out the first vero cell culture rabies vaccine in 2000. This is being marketed under the brand name Abhayrab. Post 2000, a number more vaccines were indigenously manufactured. BiO-MED in 2004 produced India Haemophilus Type B Conjugate vaccine (Peda Hib) and Meningococcal Polysaccharide vaccine Group A, C, Y & W135 (Quadri Meningo). Peda Hib is indicated for the prevention in children from six weeks to five years of age, of invasive diseases caused by Haemophilus influenzae type b e.g. Meningitis, cellulitis, epiglottitis. Quadri Meningo vaccine is recommended for children above 18 months of age as routine immunisation in endemic areas. 2006 saw HBI manufacture vaccines such as the DPT vaccine – AbhayTAG, Tetanus Vaccine – AbhayTOX and Recombinant Hepatitis B – Elovac B. SII in 2007 launched its indigenously manufactured low-cost Haemophilus influenza type b conjugate vaccine under the brand name HibPRO in India. BBIL developed BioHib, Haemophilus Influenzae Type b (Hib) vaccine in India, and Comvac 4-HB, a tetravalent combination vaccine. Bio-Med in the same year unveiled Botulinum Toxin Type A (Boto Genie). This is a potent neurotoxin complex which causes relaxation of muscles, marked reduction in gland secretory activity and silencing of nociceptor function on its absorption. The following year saw BiO-Med unveil the commercially available Typhoid Vi Conjugate vaccine (Peda Typh) that is indicated for active immunisation against Salmonella typhi in infants of the age of three months, children and adults. Cadila Healthcare introduced the H1N1 vaccine in 2010 marketed under VaxiFlu-S, the first indigenous vaccine against swine flu. It was followed by SII indigenously developing an intranasal vaccine, Nasovac, for preventing H1N1 infections. In 2011, BiO-Med developed its own Meningococcal Polysaccharide vaccine Group A & C (Bi Meningo) that is used to protect against cerebrospinal meningitis and other diseases caused by Neisseria meningitidis (Group A & C). BBIL in 2013, launched the world's first clinically proven typhoid conjugate vaccine Typbar-TCV, a fourth-generation vaccine against typhoid disease. Typbar was the first vaccine in India to get a WHO-GMP prequalification certificate. BBIL also developed the oral rotavirus vaccine, ROTAVAC, the first indigenously developed Rotavirus vaccine in 2015.     The following year saw New Delhi-based Panacea Biotec announcing the launch of Tetravalent Vaccine Easyfour-TT for active primary immunisation and booster dose against diphtheria, tetanus and pertussis (DTP) and Haemophilus Influenzae Type B(Hib). 2017 saw Zydus Cadila indigenously develop, manufacture and launch India’s first vaccine against H1N1 - Vaxiflu-S. Besides, Panacea Biotec launched the world's first fully liquid whole cell Pertussis (wP)-based Hexavalent Combination Vaccine, EasySix. BiO-MED also unveiled the latest Technology (Ultracentrifugal purified) Vero cell-based Rabies vaccine for Human use (Sure Rab) in the same year. It also launched the Varicella vaccine (Bio Pox) the following year. Ankleshwar-based Chiron Behring Vaccines announced the re-launch of a purified chick embryo cell (PCEC) vaccine manufactured at its WHO pre-qualified facility in Ankleshwar, Gujarat as ChiroRab in 2019. In the same year, BBIL launched Rotavac 5D used in the prevention of rotavirus diarrhoea, the world’s first and only liquid formulation with the lowest dosage form. In 2020, SII announced the launch of India’s first indigenously developed pneumococcal vaccine – PNEUMOSIL. This vaccine was launched through a collaboration spanning over a decade between the Serum Institute of India, PATH and the Bill and Melinda Gates Foundation.   COVID-19 shots  COVID-19 opened new avenues for Indian vaccine manufacturers and in 2021, BBIL launched Covaxin, India's first indigenously manufactured COVID-19 jab, developed in collaboration with the Indian Council of Medical Research (ICMR) - National Institute of Virology (NIV). This was followed by Ahmedabad-based pharma firm Zydus Cadila receiving the Emergency Use Authorisation (EUA) from the Drug Controller General of India (DCGI) for ZyCoV-D the world’s first Plasmid DNA Vaccine for COVID-19. The needle-free drug has been developed in partnership with the Department of Biotechnology, Government of India under the ‘Mission COVID Suraksha’ and implemented by BIRAC. The year 2022 saw many indigenous vaccines being launched in India. Starting with SII’s cervical cancer vaccine CERVAVAC, it was followed by BBIL unveiling iNCOVACC, the world’s first intranasal COVID-19 vaccine. The vaccine has been developed in collaboration with Biotechnology Industry Research Assistance (BIRAC). Hyderabad-based Biological E (BE) in the same year announced the publication of Corbevax, the indigenously produced RBD-protein subunit vaccine.     Pune-based Gennova Biopharmaceuticals, a subsidiary of Emcure Pharmaceuticals, has announced that its mRNA vaccine – GEMCOVAC-19 - received the Emergency Use Authorisation (EUA) from the office of the Drugs Controller General of India (DCGI).  GEMCOVAC-19 is the very first mRNA vaccine developed in India and the only third mRNA vaccine to be approved for COVID-19 in the world. Ahmedabad-based Cadila Pharmaceuticals developed a novel three-dose recombinant nano-particle-based rabies G protein vaccine.   Way to go 2023 will see the launch of vaccines for Hepatitis A (Hep A) and Measles and Rubella (MR) by Hyderabad–based Indian Immunologicals Limited. Besides human vaccines, the company is also working on multiple animal vaccines projects such as Foot Rot (Sheep), Canine 10-in-1 (Dog), MegaVac- KeC (Dog), Lumpy Skin Disease (Cattle), Mastitis (Cattle) 4 in 1, gE deleted IBR marker vaccine (Cattle). Biotech startup Mynvax, incubated at the Indian Institute of Science (IISc) in Bengaluru, has developed an adjuvant subunit-based vaccine against SARS-CoV-2 which is now ready for pre-clinical trials. The Technology Development Board (TDB), Ministry of Science & Technology is supporting Hyderabad-based startup Sapigen Biologix for the development and commercialisation of two novel vaccines – Intranasal COVID-19 Vaccine and RTS, S Malaria Vaccine. Under the agreement signed, TDB and Bharat Biotech have pledged the support of Rs 200 crore each to create a continuous corpus of Rs 400 crore for the development and commercialisation of the two novel vaccines. The company intends to produce 100 million doses/annum of intranasal COVID-19 vaccine by April 2023 and 15 million doses/ annum RTS, S Malaria vaccine by the end of April 2025.   The future Traditional vaccines have an upper hand having fewer side effects and Indian vaccine manufacturers have struck the right chord while dealing with the manufacture of indigenous vaccines. As compared to the mRNA COVID vaccines that have side effects, indigenous vaccines like Covaxin are known to have lesser or no side effects. The Department of Biotechnology has taken steps to curb the COVID-19 threat and as Union Minister of State (Independent Charge) Science & Technology, Dr Jitendra Singh rightly points out that India will make significant investments in R&D to develop a roadmap for the design and delivery of vaccine development for a future pandemic.  The COVID-19 pandemic was an urgent wake-up call and developing the right vaccines at the right time is what Indian vaccine manufacturers need to look up to. The Union Minister of Science & Technology Dr Singh rightly said, "India was able to develop four COVID-19 vaccines while the whole world was struggling to make even one and contributed to the global fight against COVID-19 by providing vaccine to several countries, under ‘Vaccine Maitri’ initiatives." Dr Singh also mentioned that while efforts are still on to uncover findings about COVID-19 and the epidemiological models, India is ready to invest in future challenges.   Sanjiv Das sanjiv.das@mmactiv.com ]]> <![CDATA[Serum Institute of India to set up research centre for infectious diseases in Hyderabad]]> https://biospectrumindia.com/news/95/22656/serum-institute-of-india-to-set-up-research-centre-for-infectious-diseases-in-hyderabad.html https://biospectrumindia.com/news/95/22656/serum-institute-of-india-to-set-up-research-centre-for-infectious-diseases-in-hyderabad.html Mon, 20 Feb 2023 00:00:00 +0530 Serum Institute of India (SII), the largest vaccine manufacturer, has announced establishment of Dr. Cyrus Poonawalla Centre of Excellence (CoE) in Infectious Diseases and Pandemic Preparedness in Hyderabad.    The discussion for developing this CoE started during the World Economic Forum in May 2022, with Minister K.T. Rama Rao, Minister for Municipal Administration & Urban Development, Industries & Commerce, and Information Technology, Government of Telangana. However, the official announcement came in during a virtual meeting, held on 19th February 2023.   The CoE is being set up for providing the community with a centralised location for information, resources & support during times of public health emergencies. It will provide updates on current epidemics, as well as offer resources & support to those who have been affected.   "The opening of this Centre of Excellence marks a significant step forward in our efforts to protect the health and well-being of our community. By centralising our resources and expertise, we can ensure a quick and effective response to any public health emergency", said the Minister.   Principal Secretary of Industries and Commerce Department, Jayesh Ranjan and  Director, Lifesciences, Shakthi Nagappan were present during the virtual meeting. ]]> <![CDATA[Novo Nordisk India celebrates 100th global anniversary]]> https://biospectrumindia.com/news/95/22649/novo-nordisk-india-celebrates-100th-global-anniversary.html https://biospectrumindia.com/news/95/22649/novo-nordisk-india-celebrates-100th-global-anniversary.html Thu, 16 Feb 2023 00:00:00 +0530 Novo Nordisk in India marked the company’s 100th global anniversary in a grand event on 16th February 2023 in Bengaluru and reaffirmed its commitment to providing care for people with diabetes, haemophilia, and other chronic diseases through its ’Driving Change for Generations’ campaign. On this occasion, the company launched a digital employee community outreach portal aimed at encouraging employees to volunteer for community service and give back to the society.  The digital community outreach portal will enable all employees to make significant contributions through their time, efforts, and skills. They will be able to collaborate with non-profit organisations across the nation, virtually or in-person.  As part of its centennial celebrations, Novo Nordisk set up a digital heritage gallery tracing back its rich historical milestones in the field of pharmaceutical innovations and breakthroughs. The official foundation date of Novo Nordisk is 16 February 1923. This combines two defining moments in the company’s history: (i) the establishment of Nordisk Insulinlaboratorium in 1923,  and (ii) the day Novo Terapeutisk Laboratorium introduced its first insulin on 16 February 1925. The company kicked-off a century of advancement in protein-based medicines for those living with debilitating chronic conditions. Novo Nordisk insulins have been available in India since 1935, spanning more than 80 years. In the last one year, the company has achieved major milestones in the country including the launch of GLP-1 RA in oral form, a game-changer in diabetes management.  With an aim to improve access to diabetes care in India, Novo Nordisk Education Foundation (NNEF) has also established various Centres of Excellence (CoEs) in collaboration with several public institutions including the Government of Karnataka; Indira Gandhi Medical College, Bangalore; Osmania Medical College, Hyderabad; Gandhi Medical College, Hyderabad; Government Institute of Medical Sciences (GIMS), Greater Noida, King George Medical College, Lucknow, and Aligarh Muslim University (AMU), Aligarh. The company has also launched CDiC programmes in India to help underprivileged children and young adults with Type 1 diabetes by providing them with the necessary care.     Image caption (L-R) : Vikrant Shrotriya , CVP & MD, Novo Nordisk India; Freddy Svane, Ambassador at the Royal Danish Embassy in New Delhi, Kapil Dev, former Indian cricketer and Brand Ambassador for Novo Nordisk India , Dr K M Prasanna Kumar, Renowned endocrinologist and Type 1 Diabetes expert; John Dawber, Corporate Vice President and Managing Director, Novo Nordisk Global Business Services.   ]]> <![CDATA[UW-Madison One Health Centre in India to advance vaccines, therapeutics & global health education]]> https://biospectrumindia.com/news/95/22591/uw-madison-one-health-centre-in-india-to-advance-vaccines-therapeutics-global-health-education.html https://biospectrumindia.com/news/95/22591/uw-madison-one-health-centre-in-india-to-advance-vaccines-therapeutics-global-health-education.html Sun, 05 Feb 2023 00:00:00 +0530 University of Wisconsin (UW)-Madison Global Health Institute (GHI) in the US and the Ella Foundation, founded by Dr Krishna Ella and Suchitra Ella, signed a bi-lateral agreement in New Delhi recently to establish the first ever UW-Madison One Health Centre in Bengaluru. The Centre is expected to be operational by end of 2023. UW-Madison One Health Centre will advance the development and production of new vaccines for India. Furthermore, the partnership will enable collaboration across disciplines and geographic boundaries, provide Indian students and researchers access to UW expertise and training, and build research capacity in India. One of the key benefits of the One Health Centre is to provide opportunities for UW students and researchers to work first-hand with emerging infectious diseases, collaborate with new colleagues, and see how environment, politics, and social structures affect health. “Both Ella Foundation and UW-Madison GHI share a common vision to advance innovation in science, research, and knowledge sharing. Establishing the UW-Madison Global One Health Centre holds great significance as it will advance global health through research, education, and community engagement by facilitating student, faculty exchanges, research and education,” said Dr Krishna Ella, Director, Ella Foundation, Co-Founder and Executive Chairman of Bharat Biotech. UW-Madison GHI Director Dr Jorge Osorio said, “The partnership between GHI and the Ella Foundation will continue GHI’s outreach efforts to establish a One Health Centre in India. The India One Health Centre joins a global network that includes Africa and Latin America and will open new opportunities for research, education, and provide actionable outcomes to benefit humans, animals, and ecosystems that advance equitable and sustainable health across India and the world."   Image caption- Dr Krishna Ella, Director, Ella Foundation, Co-Founder and Executive Chairman of Bharat Biotech (L) and UW-Madison GHI Director Dr Jorge Osorio    ]]> <![CDATA[Indian Immunologicals set to roll out Hepatitis A and MR vaccines in 2023]]> https://biospectrumindia.com/news/95/22590/indian-immunologicals-set-to-roll-out-hepatitis-a-and-mr-vaccines-in-2023.html https://biospectrumindia.com/news/95/22590/indian-immunologicals-set-to-roll-out-hepatitis-a-and-mr-vaccines-in-2023.html Sat, 04 Feb 2023 00:00:00 +0530 Hyderabad-based vaccine manufacturer Indian Immunologicals Limited (IIL) is all ready to launch vaccines for Hepatitis A (Hep A) and for Measles and Rubella (MR) in 2023. At the Genomics India Conference 2023 in Bengaluru recently, Dr K Anand Kumar, Managing Director, Indian Immunologicals Limited said that there are multiple human vaccine projects underway currently at IIL. "We are working on live attenuated COVID-19 and dengue vaccines, bi-valent typhoid vaccine and vaccines for polio, chikungunya and zika", he said. Besides human vaccines, the company is also working on multiple animal vaccines projects such as Foot Rot (Sheep), Canine 10-in-1 (Dog), MegaVac- KeC (Dog), Lumpy Skin Disease (Cattle), Mastitis (Cattle) 4 in 1, gE deleted IBR marker vaccine (Cattle). With a revenue generation of Rs 815 crore during FY21-22, the company is now looking towards clocking in a figure of Rs 1000 crore this fiscal. IIL has also recently forayed into a novel space of developing fish vaccines using genomic technologies. "There are many areas of vaccine development where genomics can be used such as to understand pathogenesis, to identify virulence factors, to identify conserved regions, reduce the number of valency, instant sequencing of new threats and comparison with known organisms to help figure out a strategy to develop vaccines", Dr Anand added.   ]]> <![CDATA[Union Health Minister unveils world’s first intranasal COVID-19 vaccine iNNCOVACC]]> https://biospectrumindia.com/news/95/22536/union-health-minister-unveils-worlds-first-intranasal-covid-19-vaccine-inncovacc.html https://biospectrumindia.com/news/95/22536/union-health-minister-unveils-worlds-first-intranasal-covid-19-vaccine-inncovacc.html Thu, 26 Jan 2023 00:00:00 +0530 Dr Mansukh Mandaviya, Union Minister of Health & Family Welfare, unveiled the iNNCOVACC COVID-19 vaccine on 26th January 2023 in the presence of Union Minister of State (IC) for Science and Technology, Dr Jitendra Singh. iNNCOVACC is the world’s first intranasal COVID-19 vaccine to receive approval for the primary 2-dose schedule, and as a heterologous booster dose. It is developed by Bharat Biotech International Limited (BBIL) in collaboration with Biotechnology Industry Research Assistance (BIRAC), a PSU under the Dept of Biotechnology, Ministry of Science and Technology. Congratulating BBIL for innovating another vaccine in collaboration with BIRAC, Dr Jitendra Singh said that “India has taken a lead in developing vaccines and medicines for diseases common in the developing world. Next step would be to develop vaccines for non-communicable diseases”. A rollout of iNCOVACC is expected to begin in private hospitals that have placed advance orders. Initial manufacturing capacity of several million doses per annum has been established, which can be scaled up to a billion doses as required. iNCOVACC is priced at Rs 325/dose for large volume procurement by State Governments and Govt of India. ]]> <![CDATA[DCGI approves MSD's immunotherapy for cervical cancer treatment]]> https://biospectrumindia.com/news/95/22524/dcgi-approves-msds-immunotherapy-for-cervical-cancer-treatment.html https://biospectrumindia.com/news/95/22524/dcgi-approves-msds-immunotherapy-for-cervical-cancer-treatment.html Tue, 24 Jan 2023 00:00:00 +0530 MSD (tradename of Merck & Co.) has announced that the Drugs Controller General of India (DCGI) has approved Keytruda (pembrolizumab), MSD’s anti-PD-1 therapy, for the treatment of persistent, recurrent, or metastatic cervical cancer in adults whose tumours express PD-L1 with a CPS ≥1. In addition, Keytruda has also been approved for the first-line treatment of patients with locally advanced unresectable or metastatic carcinoma of the esophagus or HER-2 negative gastroesophageal junction adenocarcinoma, in adults whose tumors express PD-L1 with a CPS ≥ 10. The approval was based on the Phase 3 Keynote 590 and 826 studies for esophageal and cervical cancer respectively. Commenting on the approval, Rehan A. Khan, Managing Director, MSD India Region said “Timely access to new and innovative treatment strategies for cancer patients is essential in improving the quality of care, and alleviating the burden of cancer on the economy, society and the wider community in India.” Keytruda is bringing a clinically meaningful shift in cancer management in India. It is the first cancer immunotherapy to be approved in India for the treatment of cervical cancer and the first immunotherapy to be approved as a first-line treatment for a significant sub-group of patients, who otherwise only had the option of chemotherapy as their treatment for esophageal cancer. Keytruda is an anti-programmed death receptor-1 (PD-1) therapy that works by increasing the ability of the body’s immune system to help detect and fight tumor cells. It is a humanised monoclonal antibody that blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells.  ]]> <![CDATA[ENTOD Pharma launches nanotech-based ocular aesthetic range of products]]> https://biospectrumindia.com/news/95/22462/entod-pharma-launches-nanotech-based-ocular-aesthetic-range-of-products.html https://biospectrumindia.com/news/95/22462/entod-pharma-launches-nanotech-based-ocular-aesthetic-range-of-products.html Tue, 10 Jan 2023 13:25:00 +0530 Mumbai-based ENTOD Pharmaceuticals has recently launched its new ocular aesthetic range focused on improving eye comfort and enhancing the aesthetics of the eyes. The products have been launched under the brands Eyecirque, Lashfactor and Vasuki.The Eyecirque range consists of the world's first nanotechnology-based gel serum, under-eye skin brightening and anti-ageing tablets, lubricating eye drops and essential eye supplements. The nanotechnology-based biocellular formula contains carefully curated, tested and scientifically proven plant-based natural ingredients that are thoroughly safe for the skin around the eyes. The Lashfactor range contains thoroughly researched premium eye serums developed by ENTOD's skin and eye researchers to enhance the natural beauty of the eyes. All the eye serums contain scientifically proven plant-based ingredients and incorporate ground-breaking nanotechnology which allows greater and faster absorption, giving more rapid and prominent results. The Vasuki Facial Gel Serum is another clinically tested, nanotechnology-based synthetic tripeptide neurotoxin snake venom complex which gently relaxes muscle contractions under the skin and is effective in reducing both dynamic and static lines in early ageing skin. It reduces and prevents expression wrinkles and fine lines around the forehead, eyes, neck, hands and lips without any impact on facial expressions. ]]> <![CDATA[Too Much Of A Good Thing- COVID-19 Vaccines?]]> https://biospectrumindia.com/views/95/22424/too-much-of-a-good-thing-covid-19-vaccines.html https://biospectrumindia.com/views/95/22424/too-much-of-a-good-thing-covid-19-vaccines.html Sun, 01 Jan 2023 00:00:00 +0530 During the first half of 2021 vaccine manufacturers were on a spree to launch their products anticipating that public apprehension will remain the same in 2022 as it was there in 2019 when COVID-19 struck. Three years down the line it is a different story altogether. Indian manufacturers Serum Institute of India (SII) and Bharat Biotech have now decided to stop manufacturing COVID-19 vaccines altogether due to hesitancy among the general public. During the recently held annual general meeting of the Developing Countries Vaccine Manufacturers Network (DCVMN) in Pune, Adar Poonawala, CEO, SII, was quoted saying “To be honest, I am fed up with COVID vaccines.” The COVID-19 vaccination drive began on January 16, 2020, with much fanfare and in 2022 it all fizzled out. The Government of India announced a free booster campaign from July 15 to September 30, 2022. More than 150 million adults received booster doses. More than 95 million people between 18 and 45 years received precautionary doses till September 29, according to the Health Ministry. The count of people between 45 and 60 years who have taken their boosters has increased 12-fold — from 3.7 million up to July 15 to 48 million on September 29.  Despite all the moves, it was found that large proportions of eligible adults shied away from booster doses where only 95 million opted for booster doses out of the 515 million that went in for the second dose.   Way back in 2020 It was in the year 2020 when 30 vaccine projects were initiated in India. India adopted a cross-functional collaborative approach, globally and locally, wherein currently 30 vaccine projects are afoot against COVID-19.  Apart from SII, Bharat Biotech, companies like Biological E., Panacea Biotech, Premas Biotech etc. took part in vaccine development activities. Vaccine manufacturers also teamed up with the academia and government to accelerate indigenous development of the COVID-19 vaccine. Indian Council of Medical Research (ICMR) and Hyderabad-based Bharat Biotech have partnered to develop a fully indigenous vaccine for COVID-19 using the virus strain isolated at ICMR’s National Institute of Virology (NIV) in Pune. In the form of another industry-academic tie-up, the Indian Institute of Technology Guwahati (IIT-G) collaborated with Ahmedabad- based pharmaceutical company Hester Biosciences for vaccine development against COVID-19. Researchers from the Hyderabad-based Centre for Cellular and Molecular Biology (CCMB) embarked upon developing an inactivated virus vaccine for the dreaded novel coronavirus. Besides IIT Kanpur; Gennova Pharmaceuticals, Pune; Auro Vaccines, Hyderabad; Christian Medical College, Vellore; IIT Delhi; IIT Kharagpur; Central Drug Research Institute, Lucknow; National Institute of Immunology, New Delhi; International Centre for Genetic Engineering and Biotechnology (ICGEB), New Delhi; Seagull Biosolutions, Pune; Mynvax, Bengaluru etc. all took part in the vaccine development activities. And the list goes on. Despite all the initiatives and a lot of money being invested, two years down the line, all the enthusiasm has been lost. Researchers burned the midnight oil, and overcame regulatory hurdles, to launch life saving vaccines. Whether the vaccines were launched or did they see the day of light remains a mystery. And with no taker, it dealt a final blow to the initiatives.    A worrying trend   A lot of money was invested to manufacture the vaccines besides building capacity. Anticipating a huge demand then, the two major vaccine manufacturers are now on a move to eradicate the vaccines.  Bharat Biotech's Covaxin was sold for Rs 400 per dose to the government and Rs 1200 for private hospitals whereas AstraZeneca's Covishield was sold at Rs 300 per dose to government hospitals and Rs 600 per dose to private hospitals. A whopping amount of 50 million doses of Covaxin produced by Bharat Biotech is set to expire in 2023 due to poor demand. The production has already stopped.  SII has already stopped the production of Covishield in December 2021. Poonawala also mentioned that the company will dump at least 100 million doses after the products expire. The Government of India has decided against procuring more COVID vaccines as of now. The health ministry is surrendering Rs 4,237 crore of the 2022-23 budget allocation for inoculation purposes, to the finance ministry.  It may be noted that the same companies were also moving ahead to launch vaccines for children. There was a general perception of fear among the public with health experts mentioning that COVID may turn fatal for children. Here also, the vaccine manufacturers failed to make their mark. The entire concept of children getting vaccinated against COVID has lost somewhere with the government not commenting either on what is the future of the vaccines that were to be administered.  According to the COWIN website, Covovax, Corbevax and Covaxin are available for children. Recently, there was news about Bharat Biotech producing Covaxin in a hurry due to political pressure. The allegations were, however, refuted both by the Government  of India and also by the company. And no one is talking about ZyCov-D, the world’s first DNA –based vaccine that was developed by Cadila Healthcare in partnership with the Department of Biotechnology. Russia’s Sputnik vaccine is priced at around Rs 1145 per dose.  The mRNA vaccine for COVID-19 was touted as a game changer. Pune-based Genova Biopharmaceuticals, a subsidiary of Emcure Pharmaceuticals, has announced that its mRNA vaccine – GEMCOVAC-19 - has received the Emergency Use Authorization (EUA) from the office of the Drugs Controller General of India (DCGI). Nothing much has happened on this front. According to Dr ( Prof) Ajay Gambhir, Chairperson, Vaccine India and Ex National Technical Advisory Group on Immunisation (NTAGI) member, “The industry got full support of the international agencies, governments, Drug Controller General of India (DCGI), NTAGI, World Bank, Bill & Melinda Gates Foundation (BMGF) and other agencies.   However, their over-dependence on government for technical, financial, administrative and distribution (without scientific and serological follow up) led to inconsistency in the vaccine dosage (varying from one to three in short period of time) which further led to confusion and low confidence in public on the vaccine; over-dependence on the vaccine to curb and control the pandemic, in which we failed to earn confidence of public and academia. This may be due to lack of data, follow-up services and to produce omni-potent vaccines .Also led to the failure to address the serious adverse events, both in youth and elderly and win public confidence.” He went on to add, “As pandemic weaned off, the role and scope of the vaccine also weaned off by the government due to less availability in poor countries and ineffectiveness in the rich countries also due to vaccine hesitancy in most of the countries. Few countries were producing and storing most of the vaccines, while the other countries did not even get the single dose for their healthcare workers and essential workers first vaccine.  This led to global and regional disparity, questions of equity, equality along with availability and affordability came at the international level. So, the role of vaccines after the pandemic was over, became questionable as the industry was unsuccessful in delivering cheap vaccines to masses and poor countries.” Echoing similar views, Ashok Bhattacharya, Global Health Care Consultant & Growth Enabler and Former Executive Director / Country Manager of Takeda Pharmaceuticals India mentions, “We have witnessed that Serum Institute was under tremendous pressure to make Covishield available not only across the country but also in many other countries across the globe. Bharat Biotech had to respond to higher demands. High investments were made to increase the manufacturing capacity. The demand was significantly high and considering the magnitude of high infection rates coupled with government pressures for higher stock, the demand projections were more leading to higher production and inventory levels. With reduction in infection levels, there has been less interventions by the government.This has also led to idle capacity. It’s time for the organisations not to dismantle the production facility but to look forward to R&D in the area of preventive medicine, develop newer vaccines and try maximum usage of the production capacities.”   What next? Vaccine manufacturers need to go back to the drawing board to take stock of what went wrong. Manufacturing millions of doses without anticipating what is in store for the future was a wrong decision by the manufacturers not only in India but also abroad.  The government also started the 'Har Ghar Dastak' campaign to propel the vaccination drive in November 2021. In May 2022, the second part of the campaign was launched to propel the vaccination drive in school, however, the public response was less. We may come across many more diseases, more serious than COVID-19. Before launching any new vaccines, companies need to understand the future sentiments and anticipate the future outlook before joining the fray to launch a large number of vaccines.  The lesson learnt is that vaccine manufacturing plants should be decentralised and each country/continent should have its own vaccine manufacturing process, depending upon the local needs. There must be sharing of data and technology amongst all countries- poor or rich during the pandemic.  Adverse Event Following Immunization (AEFI) should be monitored, informed, counselled to win public confidence. Latest data must be shared with the public and made available to academia to contest any false claim or mis-information. Free vaccination drives by the government for a longer period may have made the matter less serious.  Sanjiv Das sanjiv.das@mmactiv.com   ]]> <![CDATA[Gufic Biosciences launches India's first indigenous Botulinum Toxin injection Zarbot]]> https://biospectrumindia.com/news/95/22430/gufic-biosciences-launches-indias-first-indigenous-botulinum-toxin-injection-zarbot.html https://biospectrumindia.com/news/95/22430/gufic-biosciences-launches-indias-first-indigenous-botulinum-toxin-injection-zarbot.html Fri, 30 Dec 2022 00:00:00 +0530 Mumbai-based Gufic Biosciences has launched indigenously produced ‘Zarbot’ (Botulinum Toxin Type A) injection in India. ‘Zarbot’ was unveiled by  Dr Dirk Dressler, Dr Balaram Singh and several other prominent healthcare practitioners of India in a well-attended event held in Mumbai recently. ‘Zarbot’ has been developed and manufactured in collaboration with US-based Prime Bio. One of the most important USPs of Zarbot is that it has been manufactured using purified HALL strain and proprietary technology which results in thin film formulation and better stability compared to other botulinum toxin brands.  Zarbot is an effective option for treating certain neurological conditions which can be more challenging with conventional therapy. It comes in a unique pack with 10 ml normal saline to improve compliance and can be stored at 2-8 °C for 36 months or 25 °C for 6 months before reconstitution and is also stable up to 14 days at 2-8 °C after reconstitution and multiple withdrawal of injection solution from vial under aseptic precautions. The event thronged by the key opinion leaders from across the globe also witnessed the launch of the first state-of-the-art Centre of Excellence for Botulinum Toxin in India by Gufic. Currently only limited healthcare practitioners in India are well versed in injection technique of Botulinum Toxin. In this backdrop the Centre of Excellence launched by Gufic will offer training to healthcare practitioners on techniques of delivering complex injectable products like Botulinum Toxin.    ]]> <![CDATA[Bharat Biotech to roll-out intranasal COVID-19 vaccine at Rs 800 for private market]]> https://biospectrumindia.com/news/95/22417/bharat-biotech-to-roll-out-intranasal-covid-19-vaccine-at-rs-800-for-private-market.html https://biospectrumindia.com/news/95/22417/bharat-biotech-to-roll-out-intranasal-covid-19-vaccine-at-rs-800-for-private-market.html Tue, 27 Dec 2022 00:00:00 +0530 Hyderabad-based Bharat Biotech has announced that iNCOVACC (BBV154), is scheduled to be introduced in the country as a booster dose shortly. Earlier this month, Bharat Biotech received approval from the Central Drugs Standard Control Organization (CDSCO) for the use of heterologous booster doses of iNCOVACC.   The vaccine is now available on CoWin, and priced at Rs 800 for private markets and priced at Rs 325 for supplies to Govt of India and State Governments.   iNCOVACC has been specifically formulated to allow intranasal delivery through nasal drops. The nasal delivery system has been designed and developed to be cost-effective in low- and middle-income countries.     As a needle-less vaccination, Bharat Biotech's iNCOVACC will be India's first such booster dose. India will now have more options when it comes to third doses or precautionary doses.   Despite the lack of demand for COVID-19 vaccines, Bharat Biotech continued product development in intranasal vaccines, to be well-prepared with platform technologies for future infectious diseases.    iNCOVACC is stable at 2-8°C for easy storage and distribution. Bharat Biotech has established large manufacturing capabilities at multiple sites across India, including Gujarat, Karnataka, Maharashtra and Telangana, with operations pan India.   ]]> <![CDATA[ICAR transfers vaccine technology for avian influenza to biopharma firms]]> https://biospectrumindia.com/news/95/22420/icar-transfers-vaccine-technology-for-avian-influenza-to-biopharma-firms.html https://biospectrumindia.com/news/95/22420/icar-transfers-vaccine-technology-for-avian-influenza-to-biopharma-firms.html Tue, 27 Dec 2022 00:00:00 +0530 ‘Inactivated low pathogenic avian influenza (H9N2) vaccine for chickens’, developed by scientists at the National Institute of High Security Animal Diseases (NIHSAD) of Indian Council of Agricultural Research (ICAR), Bhopal has been transferred to multiple biopharma companies- Globion India, Secunderabad; Venkateshwara Hatcheries, Pune; Indovax, Gurgaon and Hester Biosciences, Ahmedabad, facilitated by Agrinnovate India (AgIn) at the National Agricultural Science Complex (NASC), New Delhi. The event was graced by Dr Himanshu Pathak, Secretary (DARE) & Director General (ICAR) and Chairman, AgIn, Dr B.N. Tripathi, DDG (Animal Science), Dr Praveen Malik, CEO, Agrinnovate India, Dr Aniket Sanyal, Director ICAR-NIHSAD, representatives of commercial firms, other officials from ICAR and AgIn. Dr Himanshu Pathak appreciated the efforts of the ICAR-NIHSAD scientists in development of the first indigenous vaccine for H9N2 virus and commended the Agrinnovate India for the efforts in the transfer of the technology to the industry. Dr B.N. Tripathi asserted that the vaccine will meet the standard of the market both in India and abroad. The vaccine will contribute significantly to increasing the income of poultry farmers by reducing the economic loss due to the disease. ]]> <![CDATA[No urgent relief to Serum Institute of India in Rs 100 Cr defamation case]]> https://biospectrumindia.com/news/95/22403/no-urgent-relief-to-serum-institute-of-india-in-rs-100-cr-defamation-case.html https://biospectrumindia.com/news/95/22403/no-urgent-relief-to-serum-institute-of-india-in-rs-100-cr-defamation-case.html Fri, 23 Dec 2022 00:00:00 +0530 Pune-based vaccine manufacturer Serum Institute of India (SII) would now have to wait till 3 January 2023 when the Bombay High Court will hear the matter for urgent reliefs in company’s Rs 100 crore defamation suit.  The company is seeking damages from organisations and individuals who were allegedly posting erroneous content against the Covishield vaccine manufacturer and its Chief Executive Officer Adar Poonawalla. A bench of Justice N J Jamadar has refused to pass any restraining order yesterday stating that the papers were bulky and that it did not have the time to pass an immediate order without hearing the parties. SII's suit is against the defendants from Anarchy for Freedom India and Awaken India Movement, who have been posting and circulating allegedly defamatory content against the company. According to the suit filed, the defendants have been posting content alleging that the COVID-19 vaccine Covishield, manufactured by SII in collaboration with Oxford University and AstraZeneca, has caused deaths of multiple persons due to side effects. The SII plea for urgent relief was to temporarily restrain the defendants from publishing any content against the company and its employees. The defendants filed a counterclaim for withdrawal of suit and sought SII's prosecution for allegedly making incorrect statements about Covishield effects.  Justice Jamadar gave time to SII to respond before the next date of hearing on January 3, 2023. In case of urgent relief, the court granted liberty to the company to approach vacation court.     ]]> <![CDATA[Serum Institute of India ships 40,000 doses of Oxford’s Ebola vaccine to Uganda]]> https://biospectrumindia.com/news/95/22365/serum-institute-of-india-ships-40000-doses-of-oxfords-ebola-vaccine-to-uganda.html https://biospectrumindia.com/news/95/22365/serum-institute-of-india-ships-40000-doses-of-oxfords-ebola-vaccine-to-uganda.html Thu, 15 Dec 2022 00:00:00 +0530 Oxford’s Ebola vaccine candidate has been shipped to Uganda, just 80 days after the World Health Organisation (WHO) declared a Sudan ebolavirus outbreak, having been manufactured by its partner the Serum Institute of India (SII) and working in close partnership with WHO. Following presentation of key data to the WHO generated in Oxford by Prof Lambe's team, it was announced on 17th November that the vaccine had been recommended for inclusion in a ring vaccination trial to combat a Sudan ebolavirus outbreak in Uganda. The WHO working in partnership with the Ugandan government and Ministry of Health have enabled the ring vaccination trial as part of a multi-faceted effort to curb the outbreak and save lives. The Oxford team led by Prof Lambe have been working on the vaccine for some time, including ongoing clinical trials in Oxford and Tanzania; manufacture scale-up was led by the Serum Institute and supported by Prof Sandy Douglas, of the Jenner Institute. This research was funded by the Department of Health and Social Care (DHSC). SII, who also partnered with the University to manufacture the COVID-19 vaccine, produced 40,000 doses for the trial in just a few short weeks.   ]]> <![CDATA[Bharat Serums and Vaccines to market NexoBrid in India for treatment of severe burns]]> https://biospectrumindia.com/news/95/22353/bharat-serums-and-vaccines-to-market-nexobrid-in-india-for-treatment-of-severe-burns.html https://biospectrumindia.com/news/95/22353/bharat-serums-and-vaccines-to-market-nexobrid-in-india-for-treatment-of-severe-burns.html Tue, 13 Dec 2022 00:00:00 +0530 Mumbai-based biopharmaceutical company Bharat Serums and Vaccines (BSV) has entered into an exclusive distribution agreement with MediWound, a fully integrated biopharmaceutical company in Israel focused on next-generation biotherapeutic solutions for tissue repair and regeneration, for exclusive marketing and distribution of NexoBrid in India.  NexoBrid, a new paradigm in treatment of severe burns, is a concentrate of proteolytic enzymes enriched in bromelain, and an easy to use, topically applied product that removes eschar in four hours without harming the surrounding healthy tissues.  Speaking on this, Vishwanath Swarup, COO- Domestic Operations, BSV, said “Burn treatment and management continues to remain a public health challenge in India. According to the National Health Portal of India, as many as 70 lakh burn injuries are reported with mortality rate as high as 1.4 lakh per year, with almost 91,000 of these being women. As a leading player in the women’s health segment, it is our endeavour to widen access to NexoBrid in India in order to save and improve lives of several women in the country.” Ofer Gonen, Chief Executive Officer of MediWound said, “NexoBrid is now approved and selling in 42 countries worldwide, and we see steady growth in the markets where it is available. Approval in India represents a significant opportunity for us.  With a high incidence of burns in India, we believe that NexoBrid can offer a safer treatment towards burn management.  We also look forward to our PDUFA date of January 1, 2023 and the potential NexoBrid launch in the US during the second half of 2023 with our commercial partner, Vericel.”   ]]> <![CDATA[New funding supports technology transfer from Serum Institute to Aspen for vaccine manufacturing in Africa]]> https://biospectrumindia.com/news/95/22351/new-funding-supports-technology-transfer-from-serum-institute-to-aspen-for-vaccine-manufacturing-in-africa.html https://biospectrumindia.com/news/95/22351/new-funding-supports-technology-transfer-from-serum-institute-to-aspen-for-vaccine-manufacturing-in-africa.html Mon, 12 Dec 2022 00:00:00 +0530 Headquartered in Durban, South Africa, Aspen Pharmacare Holdings Limited will receive $30 million from the Bill & Melinda Gates Foundation and the Coalition for Epidemic Preparedness Innovations (CEPI) to support its capabilities to manufacture lifesaving routine and outbreak vaccines for Africa. The new funding from CEPI and the Gates Foundation, which includes $15 million from each organisation, will support a ten-year agreement between Aspen and Serum Institute of India that aims to expand the supply and sourcing of affordable vaccines manufactured in Africa. Through the partnership with Serum Institute, Aspen will manufacture and distribute four routine vaccines in Africa- Pneumococcal, Rotavirus, Polyvalent Meningococcal, and Hexavalent- with technology transfer activities initiating in early 2023. In addition to supporting the technology transfer of these routine vaccines, the funding from CEPI and the Gates Foundation will help sustain regional vaccine manufacturing capacity at Aspen for potential future outbreak response, with the intention of securing early access to African-produced vaccines in the event of a future public health emergency.   ]]> <![CDATA[Bharat Serums and Vaccines opens animal testing facility & QC lab at Ambernath]]> https://biospectrumindia.com/news/95/22326/bharat-serums-and-vaccines-opens-animal-testing-facility-qc-lab-at-ambernath.html https://biospectrumindia.com/news/95/22326/bharat-serums-and-vaccines-opens-animal-testing-facility-qc-lab-at-ambernath.html Tue, 06 Dec 2022 00:00:00 +0530 Mumbai-based Bharat Serums and Vaccines Limited (BSV), a leading biopharmaceutical company in India, has opened a world class animal testing facility and Quality Control (QC) laboratory at the Ambernath manufacturing plant (Maharashtra).  In line with requirements from World Health Organisation (WHO), Pharmacopeia (Indian, United States, British & European), OECD GLP, Central Drug Standards Control Organisation (CDSCO) and State Food & Drug Authority (FDA), the facility houses a team of highly qualified doctorates, veterinarians, biotechnologists, and biologists.  This facility has an Institutional Animal Ethics Committee (IAEC) appointed by the Committee for the Purpose of Control And Supervision of Experiments on Animals (CPCSEA), Govt. of India which oversees and approves all animal experiment protocols. Only after approvals, animals are bred, and experiments are conducted as per scientific and ethical norms and requirements of national laws.  BSV has also entered into agreements with government approved vendors for safe disposal of biomedical and other waste generated in the Facility as per existing standard environmental laws.    ]]> <![CDATA[Indian Immunologicals first to venture into fish vaccines]]> https://biospectrumindia.com/news/95/22298/indian-immunologicals-first-to-venture-into-fish-vaccines.html https://biospectrumindia.com/news/95/22298/indian-immunologicals-first-to-venture-into-fish-vaccines.html Mon, 28 Nov 2022 00:00:00 +0530 Hyderabad-based vaccine manufacturer Indian Immunologicals Limited (IIL) has announced a partnership with Central Institute of Fisheries Education (CIFE), Mumbai, an Indian Council of Agricultural Research (ICAR) Institute for the commercial development of vaccine against common bacterial diseases in freshwater fishes.  IIL has forayed into Aqua business in October 2022 by launching products for aquaculture health market dealing with pond management and fish or shrimp gut management. Speaking on the occasion, Dr K Anand Kumar, Managing Director, Indian Immunologicals Limited said, “IIL has introduced several innovative veterinary vaccines first to the world, like Porcine Cysticercosis vaccine, FMD+HS+BQ combination vaccine and Theileria vaccine. IIL is again the first in India to get to fish vaccines." CIFE will provide technology for two inactivated bacterial vaccines, one for Columnaris Disease, a serious condition affecting numerous freshwater fish species, and other for Edwardsiellosis that cause high degree of mortality, leading to severe economic losses. Both the diseases are extremely common in freshwater fishes and is generally considered to be ubiquitous.  Dr Priyabrata Pattnaik, Deputy Managing Director, Indian Imunologicals Limited added “IIL is planning to introduce vaccines and immunostimulants with tech transfer from various fisheries institutes under ICAR. Several fish vaccine candidates are currently being evaluated by IIL for commercialisation."  Dr CN Ravishankar, Director and Vice Chancellor of ICAR-CIFE said “In support to India’s Blue Revolution, I am glad that CIFE and IIL have come together to partner in developing India’s fist bacterial fish vaccine”. Currently there is no fish vaccine available in India on a commercial scale to prevent aquaculture infections. ]]> <![CDATA[Indian Immunologicals transports animal vaccines through drones]]> https://biospectrumindia.com/news/95/22244/indian-immunologicals-transports-animal-vaccines-through-drones.html https://biospectrumindia.com/news/95/22244/indian-immunologicals-transports-animal-vaccines-through-drones.html Mon, 14 Nov 2022 00:00:00 +0530 Department of Animal Husbandry and Dairying, Government of India, Dept of Agriculture and Animal Husbandry, Government of Arunachal Pradesh, along with Indian Immunologicals Limited (IIL) transported animal vaccines through the use of drones for the “first time in the world”.  The maiden drone flight moved from Roing to Paghlam in Arunachal Pradesh. Drone delivery of vaccines is expected to not only reach remote difficult terrains faster but also help in providing critical vaccines on time for the protection of livestock from several diseases. Tage Taki, Minister for Agriculture and Animal Husbandry, Government of Arunachal Pradesh; Upamanyu Basu, Joint Secretary (LH), Dept of Animal Husbandry and Dairying, Government of India; Sujit Nayak, Joint Commissioner (LH), Dept of Animal Husbandry and Dairying, Government of India were present along with IIL’s representatives – D Banerjee and Mainak Sen, during the event. Dr K Anand Kumar, Managing Director, Indian Immunologicals Limited, expressed great hope for further technological intervention in making vaccines available to remote locations in the country. With this, IIL has amply demonstrated the delivery of “medicines from the sky”. ]]> <![CDATA[Novo Nordisk to improve healthcare access for patients with diabetes, obesity in Karnataka]]> https://biospectrumindia.com/news/95/22238/novo-nordisk-to-improve-healthcare-access-for-patients-with-diabetes-obesity-in-karnataka.html https://biospectrumindia.com/news/95/22238/novo-nordisk-to-improve-healthcare-access-for-patients-with-diabetes-obesity-in-karnataka.html Fri, 11 Nov 2022 00:00:00 +0530 The Novo Nordisk Education Foundation (NNEF), a non-profit organisation established by the Denmark-based biopharmaceutical firm Novo Nordisk, and the Government of Karnataka have pledged to work together to improve access to education, treatment, and care for people living with diabetes and obesity in the state. The parties will work together to create an action plan that positively impacts the lives of people who live with the two chronic diseases. The proposed action plan includes the setting up of multiple Centres of Excellence (CoEs) across medical colleges in Karnataka and the education of doctors and patients who live with the condition. 67% people with type 2 diabetes (T2D) in India live with overweight or obesity and 57% of adults living with diabetes remain undiagnosed. Hence, it becomes critical to increase awareness, access to diabetes care, and help with early diagnosis for patients. Highlighting the need for healthcare access and sustainability, Freddy Svane, Ambassador at the Royal Danish Embassy, said “To make a meaningful impact in reducing the burden of chronic diseases, we must use as many hands as we can get. Public-private partnerships such as these are a great way for likeminded stakeholders to work on common goals." Data from the World Obesity Atlas 2022 shows that the economic impact of obesity in India in the year 2019 was $23 billionn (0.8% GDP) which is projected to become $479 billion (2.75% GDP) by the year 2060.   ]]> <![CDATA[Biological E to test COVID-19 vaccine Corbevax on infants as young as six months]]> https://biospectrumindia.com/news/95/22207/biological-e-to-test-covid-19-vaccine-corbevax-on-infants-as-young-as-six-months.html https://biospectrumindia.com/news/95/22207/biological-e-to-test-covid-19-vaccine-corbevax-on-infants-as-young-as-six-months.html Thu, 03 Nov 2022 00:00:00 +0530 Biological E (BE), a Hyderabad-based vaccine and pharmaceutical company, has recently announced the publication of CORBEVAX COVID-19 vaccine phase II/III clinical trials conducted in paediatric population (5 to <18 age group).  The vaccine has demonstrated excellent safety profile in children and adolescents. The vaccine also demonstrated excellent immunogenicity as measured by humoral and cellular immune responses.  Dr Vikram Paradkar, Executive Vice President-Technical Operations, Biological E. Limited, said, “CORBEVAX getting approved for our paediatric population from 5 to 18 age-group was a major milestone for us and its subsequent Pan-India deployment for kids of 12-14 years was important in our fight against coronavirus. So far, approximately 74 million doses of CORBEVAX has been administered to kids in India and almost 33 million kids have completed two-dose primary vaccination, which represents one of the largest paediatric campaigns globally.  We plan to eventually test the vaccine on infants as young as six months, based on the excellent safety record and consistent immunogenicity observed in paediatric trials and deployment." In August, CORBEVAX became the first vaccine in India to get DCGI approval for a COVID-19 heterologous booster shot. It can be administered six months after two doses of COVISHIELD or COVAXIN for all adults.   ]]> <![CDATA[Indegene to scale up AstraZeneca’s omnichannel operations across globe]]> https://biospectrumindia.com/news/95/22197/indegene-to-scale-up-astrazenecas-omnichannel-operations-across-globe.html https://biospectrumindia.com/news/95/22197/indegene-to-scale-up-astrazenecas-omnichannel-operations-across-globe.html Wed, 02 Nov 2022 00:00:00 +0530 Bengaluru-based Indegene, a digital-first, life sciences commercialisation company, has announced that it is helping AstraZeneca, a global biopharmaceutical company scale up its omnichannel operations across the globe with an aim to create a more personalized customer experience.  Indegene will leverage its healthcare domain expertise and experience in operating digital centers of excellence to help streamline the client’s global content supply chain and orchestrate personalized customer journeys in an agile, global engagement model. Its partnerships with marketing platform providers will support the client’s omnichannel operations efficiently, and at scale. Sanjay Parikh, Executive Director and EVP, Indegene, said, “As patients and physicians progressively engage with life sciences companies through a wide variety of communication channels, omnichannel operations are vital to create personalised experiences at scale. We are excited at the opportunity to apply our healthcare domain expertise and technology accelerators to enable and empower life sciences companies on their omnichannel journey.” ]]> <![CDATA[Absstem Technologies to bridge maintenance gap of medical oxygen generators]]> https://biospectrumindia.com/news/95/22181/absstem-technologies-to-bridge-maintenance-gap-of-medical-oxygen-generators.html https://biospectrumindia.com/news/95/22181/absstem-technologies-to-bridge-maintenance-gap-of-medical-oxygen-generators.html Thu, 27 Oct 2022 01:05:00 +0530 New Delhi-based Absstem Technologies, a leading medical technology provider and medical gas generator manufacturer, has come up with a new initiative called Absstem Shield, under which Annual Maintenance Contracts (AMC) and Comprehensive Maintenance Contracts (CMC) will be offered for oxygen generators. The devastating nationwide second wave of the COVID-19 pandemic saw hospitals, across the country, installing pressure swing adsorption (PSA) oxygen generation plants, to ensure adequate supply for the patients. However, with the demand for oxygen in hospitals across the country going back to nearly pre-pandemic times, Absstem Shield, with its maintenance services, will now ensure these plants don’t become obsolete and non-functional in times of need. Absstem Shield has roped in expert professionals, engineers, and technicians for the repair and maintenance of PSA plants and VPSA (Vaccum pressure swing adsorption) plants. Commenting on the launch of this novel venture, Amit Kumar, National Service Head of Absstem Technologies said, “The primary issues at hand in most states are that majority of generators are either having inconsistent output purity levels of oxygen or just deteriorating remaining idle. When installed through uncertified channels, we are getting the feedback that most machines aren’t delivering the desired oxygen purity levels at all times, or just expensive spares taking at least a month to replace. They are expensive machines. They are built to last for a very long time. This only happens when the machine is running and well-maintained. As a large number of these generators are entering their second year of operations, warranties are expected to end. Absstem Shield plans include AMCs that include constant monitoring, monthly status updates, on-site visits and one of the quickest turn-around times in the country." ]]> <![CDATA[Medtronic to separate combined Patient Monitoring & Respiratory Interventions biz]]> https://biospectrumindia.com/news/95/22174/medtronic-to-separate-combined-patient-monitoring-respiratory-interventions-biz.html https://biospectrumindia.com/news/95/22174/medtronic-to-separate-combined-patient-monitoring-respiratory-interventions-biz.html Tue, 25 Oct 2022 00:00:00 +0530 Ireland headquartered medical technology firm Medtronic plc has announced its intention to pursue a separation of the company's combined Patient Monitoring and Respiratory Interventions businesses (NewCo), which are part of the company's Medical Surgical Portfolio. The separation will enable greater investment focus in the areas of highest strategic priority across the company, and will facilitate the execution of its leadership strategy in attractive medtech markets that leverage the company's strengths.  NewCo is expected to be a premier partner for connected care solutions with best-in-class brands and leading positions in patient monitoring and critical care: The Patient Monitoring technology portfolio includes Nellcor pulse oximetry, Microstream capnography, BIS brain monitoring, INVOS perfusion monitoring, and HealthCast connected care solutions. The Respiratory Interventions technology portfolio includes Puritan Bennett ventilators, Shiley airway portfolio, McGrath MAC video laryngoscopy, DAR breathing systems, as well as PAV+, NIV+ and IE Sync ventilation software solutions designed to improve workflow and care delivery. Patient Monitoring and Respiratory Interventions reside in the Respiratory, Gastrointestinal & Renal division within the Medtronic Medical Surgical Portfolio. In fiscal year 2022, the combined business generated global revenue of approximately $2.2 billion. The combined business has a constant currency revenue growth profile and gross margin profile slightly below overall Medtronic and an operating margin profile slightly higher than overall Medtronic. The combined business has a global commercial footprint and a team of more than 8,000 employees worldwide. ]]> <![CDATA[Anglo French Drugs & Industries launches respiratory care products]]> https://biospectrumindia.com/news/95/22154/anglo-french-drugs-industries-launches-respiratory-care-products.html https://biospectrumindia.com/news/95/22154/anglo-french-drugs-industries-launches-respiratory-care-products.html Fri, 21 Oct 2022 00:00:00 +0530 Bengaluru-based Anglo-French Drugs & Industries has launched new products in the pharma division: - AFD Pulmo Range in respiratory care. The range of the products that are launched are AFD-PULMO-AZI- an anti-infective: azithromycin molecule which is one of the preferred molecules in respiratory tract infections; AFD-PULMO-LS is a cough syrup for productive cough which is the largest segment in cough preparations & AFD-PULMO-A2 is a combination of Acebrophylline and Acetylcysteine- a fast-growing segment related to severe cases of bronchitis especially when there is hypersecretion of mucus in the respiratory tract leading to breathing disorders. Abhay Kanoria, Chairman & Managing Director, Anglo French Drugs & Industries said, “We have launched these products in India keeping in mind the respiratory problems that have arisen among children and adults with the emergence of COVID-19." AFD Pulmo -AZI is available in two strengths: 500mg will be sold at a maximum retail price of Rs125 per strip of 5 tabs and 250mg for Rs 125 per strip of 10 tabs. AFD-PULMO-LS will be sold at a maximum price of Rs 109 for 100 ml bottle. AFD-PULMO-A2 will be sold at a maximum retail price of Rs 180 for strip of 10 tabs.   ]]> <![CDATA[Glenmark offers new anti‐diabetic FDC medication under brand name Zita D]]> https://biospectrumindia.com/news/95/22146/glenmark-offers-new-antidiabetic-fdc-medication-under-brand-name-zita-d.html https://biospectrumindia.com/news/95/22146/glenmark-offers-new-antidiabetic-fdc-medication-under-brand-name-zita-d.html Thu, 20 Oct 2022 00:00:00 +0530 Glenmark Pharmaceuticals has became the first to launch Teneligliptin (20mg) + Dapagliflozin (5mg/10mg) fixed dose combination (FDC) for the treatment of adult patients with type 2 diabetes, especially the ones with comorbidities. Marketed under the brand name Zita D; it contains Teneligliptin (20mg) + Dapagliflozin (5 mg/10 mg), and must be taken once daily under prescription to improve glycemic control & prevent complications in adult patients with type 2 diabetes, especially the ones with comorbidities.   Teneligliptin is a widely used DPP4i (Dipeptidyl Peptidase 4) inhibitor whereas Dapagliflozin isthe most prescribed SGLT‐2i (Sodium glucose co‐transporter 2) inhibitorfor diabetic patientsin the country.  While Zita D is a promising treatment option in managing uncontrolled Type 2 diabetes with co‐morbidities, this FDC has also proven to be effective among adult diabetic patients without comorbidities. Glenmark’s Zita D is priced at around Rs 14 per tablet for FDC of Teneligliptin 20mg + Dapagliflozin 5mg, and Rs 15 per tablet for FDC of Teneligliptin 20 mg + Dapagliflozin 10 mg, per day. ]]> <![CDATA[US-based firm Model N to drive revenue optimisation solutions for life sciences companies in India]]> https://biospectrumindia.com/news/95/22140/us-based-firm-model-n-to-drive-revenue-optimisation-solutions-for-life-sciences-companies-in-india.html https://biospectrumindia.com/news/95/22140/us-based-firm-model-n-to-drive-revenue-optimisation-solutions-for-life-sciences-companies-in-india.html Wed, 19 Oct 2022 08:40:00 +0530 Model N, Inc., based in the US, has recently opened its new product innovation facility in Hyderabad. The company also announced plans to expand its software engineering talent by increasing its focus on diversity and inclusion, as well as productising new solutions that accelerate revenue optimisation and compliance for life sciences and high-tech companies. The 70,000 square foot Model N facility, housing 500 employees, was inaugurated by Jayesh Ranjan, Principal Secretary of Industries & Commerce (I&C) & IT, Government of Telangana, and Jason Blessing, President & CEO, Model N, and individuals from the Model N leadership team. The Model N Centre in Hyderabad is instrumental to bringing new product innovations to market, such as State Price Transparency Management (SPTM) and 340B solutions that help pharmaceutical manufacturers manage the fluid drug pricing regulation and management landscape. Through its innovative and market-lead approach, Model N enables life sciences and high-tech innovators to streamline operations, scale strategically, and mitigate risks—currently working with 28 out of the top 30 global life sciences brands and 14 out of the top 20 global semiconductor brands.   ]]> <![CDATA[Pfizer India expands reach of online programme on antimicrobial resistance for nurses]]> https://biospectrumindia.com/news/95/22142/pfizer-india-expands-reach-of-online-programme-on-antimicrobial-resistance-for-nurses.html https://biospectrumindia.com/news/95/22142/pfizer-india-expands-reach-of-online-programme-on-antimicrobial-resistance-for-nurses.html Wed, 19 Oct 2022 00:00:00 +0530 Pfizer India and Americares India Foundation have announced a partnership with the Trained Nurses Association of India (TNAI) to make TNAI a knowledge, outreach, and certification partner for the OPEN-AMR (Online Platform for Education among Nurses on AMR) programme. This programme is a web-based learning platform to educate nurses on anti-microbial resistance (AMR), which is one of the world’s top 10 global public health threats, according to the World Health Organization. OPEN-AMR was launched in June 2022 in partnership with along with Americares India Foundation, a health-focused relief and development organization. Improper or irrational use of antibiotics is one of the leading causes of AMR, and healthcare professionals can play a significant role in addressing it. The OPEN-AMR courses focus on Infection Prevention and Control (IPC) practices along with Antimicrobial Stewardship Practices (AMSP), which can equip nurses with the knowledge and expertise to help combat AMR.  Since its launch, the OPEN-AMR programme has facilitated easy access to a plethora of courses on Antimicrobial Resistance across hospitals free of cost, in a variety of regional languages including English, Hindi, Malayalam, Tamil, Telugu, Kannada, and Marathi. Across the country, close to 2,000 nurses have been enrolled on the OPEN-AMR platform, and the current partnership with TNAI will expand the scope of this programme to reach a wider audience. ]]> <![CDATA[Baxter unveils global pharmaceuticals R&D centre in Ahmedabad]]> https://biospectrumindia.com/news/95/22125/baxter-unveils-global-pharmaceuticals-rd-centre-in-ahmedabad.html https://biospectrumindia.com/news/95/22125/baxter-unveils-global-pharmaceuticals-rd-centre-in-ahmedabad.html Mon, 17 Oct 2022 12:00:00 +0530 Baxter Pharmaceuticals India has announced the inauguration of a global Pharmaceuticals R&D Centre in Ahmedabad. The centre will help further the company's mission of saving and sustaining lives by accelerating innovation in the generic and differentiated injectable pharmaceuticals space. The R&D Centre was inaugurated by Alok Sonig, President, Pharmaceuticals, Baxter International Inc. He was accompanied by Dr.Mahesh Chaubal, Vice President, Pharmaceuticals R&D, Baxter International Inc. and Dr Sanju Dhawan, Director of R&D, Baxter Pharmaceuticals India in Ahmedabad.   The 20,500-square-foot, state-of-the-art R&D Centre features an array of sophisticated equipment and research labs that will focus on pharmaceutical product development and capabilities in therapeutic areas such as critical care, analgesic, renal, cardiovascular anesthesia, anti-infective and antipyretic. It will support Baxter's global manufacturing facilities, including those in Ahmedabad, Germany, Ireland, Italy, and the United States, among others. This Pharmaceuticals R&D Centre is part of Baxter’s network of more than 25 global R&D centers, including 4 in the APAC region. The existing team of scientists, pharmacists, microbiologists, and analysts at the Pharmaceuticals R&D Centre have already contributed to the launch of several Baxter products globally.    ]]> <![CDATA[Hetero buys Johnson & Johnson's manufacturing plant in Telangana]]> https://biospectrumindia.com/news/95/22123/hetero-buys-johnson-johnsons-manufacturing-plant-in-telangana.html https://biospectrumindia.com/news/95/22123/hetero-buys-johnson-johnsons-manufacturing-plant-in-telangana.html Mon, 17 Oct 2022 00:00:00 +0530 Hetero has announced the acquisition of a brownfield manufacturing plant at Penjerla located in Telangana, from Johnson & Johnson. The facility spread across 55.27 acres, will be Hetero’s flagship sterile pharmaceutical and biologics manufacturing unit, bolstered by state-of-the-art technology. The acquisition reinforces Hetero’s renewed commitment to expand its reach and capabilities in order to respond with agility to the world’s evolving health needs and produce high-quality and affordable medicines. Dr Vamsi Krishna Bandi, Managing Director, Hetero, said: “We are committed to an investment upwards of $75 million, (approximately Rs 600 Cr) to upgrade and enhance existing facilities at the site and expand manufacturing of our global biologics and sterile pharmaceutical products.” With this facility, Hetero aims to add 2000 new jobs in biochemistry, pharmaceutical sciences, molecular biosciences, engineering, and ancillary services. PwC acted as the exclusive financial advisor to Hetero on the acquisition of the Penjerla manufacturing facility together with the land, plant and machinery in a slump sale from Johnson & Johnson. ]]> <![CDATA[AstraZeneca India expands clinical data & insights division in Bengaluru]]> https://biospectrumindia.com/news/95/22112/astrazeneca-india-expands-clinical-data-insights-division-in-bengaluru.html https://biospectrumindia.com/news/95/22112/astrazeneca-india-expands-clinical-data-insights-division-in-bengaluru.html Thu, 13 Oct 2022 13:00:00 +0530 AstraZeneca India, the global capability centre of leading science-led biopharmaceutical company AstraZeneca, plans to further expand its Clinical Data and Insights (CDI) division, after the new unit tripled its headcount within its first year of launch in Bengaluru. To accommodate this expansion, the Bengaluru centre recently leased additional space that was inaugurated by key global leaders on 13 October.   The continued investment will include hiring additional data experts, deepening the role that India plays in supporting and driving AstraZeneca’s growing portfolio of new medicines by further strengthening the management of global clinical data. It works across therapy areas and portfolios, supporting early and late-stage clinical programmes from Phase 1 to Phase 3 with an integrated end-to-end approach for clinical data, analytics, insights and risk management.  The CDI division today has over one hundred employees (Data managers, Programmers, Data Scientists, Data Standards experts), forming part of a global network spread across 6 countries.  Siva Padmanabhan, Managing Director, AstraZeneca India Private Limited (AZIPL) said, “With over 100 employees, the Bengaluru team is strategically supporting the global trials, and will further strengthen its role in supporting AstraZeneca's aspiration to be pioneer in science and transform patient-outcomes.”   The CDI division in Bengaluru is a critical advancement to support a growing global portfolio and build on internal data expertise. In addition to Data Management and Data Standards, functions like Centralized Monitoring, TRISARC (Trials Safety Review Centre) and SASP comprising of safety patient data review experts are also setting up their teams in the Bengaluru centre.  ]]> <![CDATA[Over 35k HCPs from India register for Abbott's a:care Congress 2022]]> https://biospectrumindia.com/news/95/22108/over-35k-hcps-from-india-register-for-abbotts-acare-congress-2022.html https://biospectrumindia.com/news/95/22108/over-35k-hcps-from-india-register-for-abbotts-acare-congress-2022.html Thu, 13 Oct 2022 09:00:00 +0530 Speaking to BioSpectrum, Dr Matthias Mueller, Divisional Vice President Innovation and Development, Abbott’s Established Pharmaceuticals business said “Our a:care Congress, taking place on October 8 & 15, is a major launch milestone in our educational efforts to address non-adherence, which has already garnered interest from more than 35,000 healthcare professionals from India.” He further said “It is endorsed by more than 60 international and national medical societies, including the Association of Physicians of India, the Hypertension Society of India, and the Indian Thyroid Association.” Talking about the investments on creating awareness about Adherence to Treatment he said “We are investing in research projects with an ongoing clinical trial on improving education adherence with digital solutions. We partnered with King's College London to offer physicians access to adherence management training, especially in India.” “Abbott is committed to continuing to broaden education on medicine adherence, and we are working to include enhanced touch points and wider therapy areas to help patients and support healthcare professionals in improving adherence and building steps toward better health in India and globally,” Dr Mueller added. Abbott's a:care programme is a unique, product-agnostic initiative that aims to improve adherence to treatment through a focus on digital tools and behavioral science to help people take back control over their health and live better. a:care Congress 2022, will be covering About the pervasive myths that hide the true drivers of non-adherence, How to shift the paradigm and treat the person, not just the disease and How patients understand adherence, and how their insights can be used in clinical practice. The congress will have regional satellite meetings to discuss key regional issues and explore insights into the regional drivers and solutions of non-adherence. There will be satellite meetings from India, Brazil, the rest of Latin America, the Middle East, Turkey, Africa and Pakistan region (METAP) and the Asia-Pacific region.   ]]> <![CDATA[Piramal Pharma Solutions launches rapid integrated approach ADCelerate]]> https://biospectrumindia.com/news/95/22103/piramal-pharma-solutions-launches-rapid-integrated-approach-adcelerate.html https://biospectrumindia.com/news/95/22103/piramal-pharma-solutions-launches-rapid-integrated-approach-adcelerate.html Thu, 13 Oct 2022 00:00:00 +0530 Piramal Pharma Solutions, Mumbai-based Contract Development and Manufacturing Organization (CDMO), has announced the launch of ADCelerate, a new, branded solution for antibody-drug conjugate drug development that accelerates timelines for developing the initial clinical supply of both drug substance and drug product. With ADCelerate, Piramal Pharma Solutions (PPS) delivers fully developed manufacturing processes for antibody-drug conjugate drug substance and lyophilized drug product, all within as few as twelve months. The programme includes qualified, Phase I appropriate analytical methods to support batch release and stability studies for both drug substance and drug product, as well as initial stability data on drug substance (six months) and drug product (one month). Peter DeYoung, Chief Executive Officer, Piramal Pharma Solutions said, "As a CDMO serving the biopharma industry, we recognize that speed matters. Getting our clients into the clinic as quickly as possible without compromising quality supports our ethos of patient centricity. ADCelerate is a strong example of this principle brought to life. By leveraging our capabilities and expertise in ADCs and sterile fill/finish, we are able to shorten timelines while maintaining the highest standards of quality." ]]> <![CDATA[Secop Group and B Medical Systems offer new generation of medical transport boxes ]]> https://biospectrumindia.com/news/95/22100/secop-group-and-b-medical-systems-offer-new-generation-of-medical-transport-boxes-.html https://biospectrumindia.com/news/95/22100/secop-group-and-b-medical-systems-offer-new-generation-of-medical-transport-boxes-.html Wed, 12 Oct 2022 12:00:00 +0530 Secop GmbH, a global leader in advanced cooling solutions for mobile battery-driven applications, commercial and medical cold chain refrigeration, and B Medical Systems, with subsidiaries in the US and India, have announced a joint development agreement to develop solutions for a new generation of medical transport boxes to safely store and transport vaccines, biospecimens, and other temperature-sensitive specimens at ultra-low temperatures even in locations with tropical ambient conditions. SECOP and B Medical Systems aim to offer a reliable and effective active medical cold chain solution through an active transport unit designed with a cascade compressor system, specifically designed to reach ultra-low temperatures even in tropical ambient conditions. Under this agreement SECOP and B Medical Systems will conduct a series of development and testing exercises, applying SECOP’s decades of experience in efficient mobile cooling compressors and B Medical Systems’ expertise in developing innovative and reliable solutions for medical transportation boxes. Engagement between Secop’s and B Medical Systems’ research and development teams on joint development activities under the agreement is now underway and both companies aim to conclude the development and testing phase in the near future to deliver this new ultra-low cold chain solution. ]]> <![CDATA[Marksans Pharma acquires formulation biz from Tevapharm India]]> https://biospectrumindia.com/news/95/22095/marksans-pharma-acquires-formulation-biz-from-tevapharm-india.html https://biospectrumindia.com/news/95/22095/marksans-pharma-acquires-formulation-biz-from-tevapharm-india.html Tue, 11 Oct 2022 12:00:00 +0530 Mumbai-based Marksans Pharma has entered into a business transfer agreement with Tevapharm India, to acquire its business relating to the manufacture and supply of bulk pharmaceutical formulations in Goa, as a going concern on a slump sale basis. Marksans has agreed to retain the site employees with existing terms of employment. The transaction is in cash consideration and is expected to be finalized by April 1, 2023, subject to the usual closing conditions. Teva's affiliate Watson Pharma will continue to own and operate its other manufacturing site at Goa. Marksans will continue to supply Teva's affiliates for certain products until the end of FY23 as part of the agreement, which can be extended further with mutual agreement. Through the acquisition, the company plans to double the existing Indian capacity from 8 billion units per annum currently. Marksans plans to manufacture tablets, hard and soft gel capsules, ointments, gummies, creams, from the new capacity. It is a scalable capacity to manufacture oral solid dosage forms. The new capacity will be an addition to the three existing manufacturing sites in Southport (UK), Farmingdale (US) and Goa (India). The manufacturing site is spread across 47,597 square meters and has approvals to manufacture products from EU, Health Canada & Japanese Health Authority.   ]]> <![CDATA[VINCOV-19, a cure against COVID-19, successfully completes Ph 2 clinical trials]]> https://biospectrumindia.com/news/95/22091/vincov-19-a-cure-against-covid-19-successfully-completes-ph-2-clinical-trials.html https://biospectrumindia.com/news/95/22091/vincov-19-a-cure-against-covid-19-successfully-completes-ph-2-clinical-trials.html Tue, 11 Oct 2022 08:00:00 +0530 VINS Bioproducts, based in Hyderabad, in collaboration with the Centre for Cellular and Molecular Biology (CCMB) and the University of Hyderabad (UoH), has announced the successful completion of Phase 2 clinical trials of VINCOV-19, India’s first antidote and a cure against SARS-CoV-2 virus. VINCOV-19 is now ready for market authorization and for simultaneous Phase 3 clinical trials. Phase 2 clinical trials were conducted across multiple centres in India and included over 200 patients. The trials also included testing the antidote against the omicron variant to ensure maximum coverage against the virus and its known mutations.  Phase 2 clinical trials were completed successfully in September 2022. In this phase, VINCOV-19 was administered to patients with moderate severity of COVID-19. One group of patients was given VINCOV-19, along with Standard of Care (SoC), and another group was given Standard of Care (SoC) only. VINCOV-19 showed excellent safety profile in the Phase 2 Trials. There was a good and early improvement in the clinical condition of the patients administered VINCOV-19. VINCOV-19 contains Equine polyclonal antibodies (EpAbs) against the COVID-19 virus. VINCOV-19 comprises highly purified F(ab’)2 antibody fragments that have a high neutralizing capacity against the SARS-CoV-2 virus. Since neutralizing antibodies could block the internalization of SARS-CoV-2 to lung cells, it was postulated that their passive administration should render maximal clinical benefits if they are applied at the early stages of the disease.     ]]> <![CDATA[US-based Amneal Pharmaceuticals begins commercial operations in India]]> https://biospectrumindia.com/news/95/22084/us-based-amneal-pharmaceuticals-begins-commercial-operations-in-india.html https://biospectrumindia.com/news/95/22084/us-based-amneal-pharmaceuticals-begins-commercial-operations-in-india.html Mon, 10 Oct 2022 17:00:00 +0530 US-based Amneal Pharmaceuticals, Inc. has launched its commercial operations in India. To helm its India commercial operations, Amneal has appointed Shyamakant Giri as Managing Director and President, India Business and Emerging Markets.  Giri has over two decades of experience leading business divisions and strategic operations of leading Indian and multinational organizations. In this new role, he will be responsible for Amneal's commercial expansion and growth in India, Africa, Gulf, CIS and South Asian markets. Amneal Pharmaceuticals Inc. has a strong manufacturing and R&D footprint in India since 2008 with a focus on exports of key molecules and products thought its state-of-the-art world-class facilities across Ahmedabad, Dahej, Hyderabad and Vizag.  With the commencement of Amneal’s India commercial operations, the company aims to serve the unmet medical needs, and extend its industry-leading reputation for high quality products at affordable prices. Delivering innovations in accessible medicines for patients and healthcare systems and building a strong foundation on honesty and integrity for the past 20+ years, the company has extended its portfolio from generics to specialty products, biosimilars and institutional injectables. ]]> <![CDATA[Panacea Biotec receives Rs 1040 Cr for Pentavalent vaccine supply]]> https://biospectrumindia.com/news/95/22085/panacea-biotec-receives-rs-1040-cr-for-pentavalent-vaccine-supply.html https://biospectrumindia.com/news/95/22085/panacea-biotec-receives-rs-1040-cr-for-pentavalent-vaccine-supply.html Mon, 10 Oct 2022 17:00:00 +0530 Panacea Biotec has received long-term supply awards worth $127.30 million (around Rs 1,040 crore) from UNICEF and Pan American Health Organization (PAHO) for supply of its WHO pre-qualified fully liquid Pentavalent vaccine, Easyfive-TT (DTwP-HepB-Hib). UNICEF award is worth $98.755 million (~Rs 813 crore) for supply of ~99.7 million doses during calendar years 2023-2027 and PAHO award is worth $28.55 million (~Rs 235 crore) for supply ~24.83 million doses during calendar years 2023-2025. Paediatric vaccination plays an important role to achieve Sustainable Development Goals (SDGs) set by the United Nations, in particular the target to reduce under-five mortality rate to less than 25 per 1000 live births. Pentavalent vaccine protects children against five deadly diseases: Diphtheria, Tetanus, Pertussis, Hepatitis B and invasive infections caused by Haemophilus Influenza Type b - becoming the foundation of paediatric immunization programmes across the world. Easyfive-TT is the world's first fully liquid wP-based Pentavalent vaccine that as launched in India in 2005. After receiving WHO prequalification in 2008, more than 150 million doses have been supplied to over 75 countries globally. EasyFive-TT is a ready-to-use combination vaccine that does not require preparation by healthcare workers at the clinic, reduces the number of visits to vaccination centres, and reduces the overall cost of immunisation for all stakeholders.  ]]> <![CDATA[PharmNXT Biotech unveils single-use bioprocessing unit in Pune]]> https://biospectrumindia.com/news/95/22075/pharmnxt-biotech-unveils-single-use-bioprocessing-unit-in-pune.html https://biospectrumindia.com/news/95/22075/pharmnxt-biotech-unveils-single-use-bioprocessing-unit-in-pune.html Mon, 10 Oct 2022 10:45:00 +0530 Mumbai-based PharmNXT Biotech has launched its first integrated manufacturing unit in Pune to provide single-use bioprocessing solutions. The state-of-the-art facility has been launched to address the challenges of biologics manufacturing in the country. The manufacturing unit will be called PharmNXT ekuse and is spread over 40,000 sq ft.    The new facility was launched at PharmNXT Biotech, the company’s facility in Chakan, Pune. Housing the latest production technology, the plant is built to provide single-use bioprocessing solutions with plans to cater to the demands of global markets such as Singapore, Korea, Europe and the US. The new facility will also generate employment opportunities for over 100 to 200 people.   The ekuse manufacturing facility will be engaged in crafting the Xelta range of single-use bioprocessing products and ‘NXTmix’ a levitating mixing technology.     ]]> <![CDATA[Lupin partners with global agencies to support tuberculosis prevention]]> https://biospectrumindia.com/news/95/22072/lupin-partners-with-global-agencies-to-support-tuberculosis-prevention.html https://biospectrumindia.com/news/95/22072/lupin-partners-with-global-agencies-to-support-tuberculosis-prevention.html Fri, 07 Oct 2022 00:00:00 +0530 Global pharma major Lupin has reached an agreement with Unitaid, The Aurum Institute, the Clinton Health Access Initiative (CHAI), and other global procurement agencies to support tuberculosis (TB) prevention treatment that will be rolled out to 138 countries, including many low-and middle-income countries with a large burden of TB. Through this agreement, Lupin will introduce two new formulations, a fixed-dose combination of Rifapentine + Isoniazid and Rifapentine 300 mg standalone tablets, at an affordable price. As a global leader in anti-TB medicines, Lupin is committed to ensuring its products are widely available in all countries and there is equitable access to treatment globally.  “We are glad to partner on these important products as this closely aligns with our mission of building better health, globally. Through this, we will further reinforce our long legacy to provide shorter, more patient-friendly treatment options to prevent TB,” said Nilesh Gupta, Managing Director, Lupin. “Lupin continues its accelerated efforts in line with WHO’s The End TB Strategy program. Our expertise in fermentation-based products and backward integration for Rifapentine, enables us to be in a unique position to provide affordable, quality TB prevention and treatment options, and save lives globally,” said Naresh Gupta, President – API and Global Institution Business, Lupin. ]]> <![CDATA[Alkem Labs launches affordable diabetes drug Dapanorm Trio]]> https://biospectrumindia.com/news/95/22069/alkem-labs-launches-affordable-diabetes-drug-dapanorm-trio.html https://biospectrumindia.com/news/95/22069/alkem-labs-launches-affordable-diabetes-drug-dapanorm-trio.html Thu, 06 Oct 2022 16:50:00 +0530 Alkem Laboratories has launched a triple-drug fixed-dose combination (FDC) of Dapagliflozin, Sitagliptin and Metformin under the brand name of Dapanorm Trio at an affordable price for adults with Type 2 Diabetes in India.Mohammed Musarif Pasha, Associate Vice President (Sales & Marketing), Alkem said, "A majority of patients in India, pay the cost of the drug from their pockets which makes the drug cost as a major deciding factor in long-term diabetes management. Dapanorm trio is priced at Rs 19.70 per tablet which is almost 70 per cent less compared to the combined cost of innovator drugs."Alkem received marketing authorization for Dapanorm Trio FDCs based on a phase III multicentric, randomised, double-blind clinical trial (MESIDA trial) which compared the efficacy of triple-drug FDC of Dapagliflozin, sitagliptin and metformin vs combination of Sitagliptin and metformin. The study was conducted on 274 patients with type 2 Diabetes across India. The result of the clinical trial showed that triple drug FDC Dapanorm Trio had superior efficacy in terms of glycemic control as compared to the dual drug combination. ]]> <![CDATA[Glenmark introduces Lobeglitazone for uncontrolled Type 2 diabetes in India]]> https://biospectrumindia.com/news/95/22064/glenmark-introduces-lobeglitazone-for-uncontrolled-type-2-diabetes-in-india.html https://biospectrumindia.com/news/95/22064/glenmark-introduces-lobeglitazone-for-uncontrolled-type-2-diabetes-in-india.html Thu, 06 Oct 2022 10:40:00 +0530 Glenmark Pharmaceuticals has launched Thiazolidinedione Lobeglitazone (Lobeglitazone) in India for the treatment of type 2 diabetes in adults. Marketed under the brand name LOBG; it contains Lobeglitazone (0.5 mg) and to be taken once daily under prescription to improve glycemic control in adult diabetic patients. Indians have a high prevalence of insulin resistance and that makes LOBG an appealing treatment option in managing uncontrolled Type 2 diabetes among insulin‐resistant diabetic patients.Glenmark earlier received approval from the Drug Controller General of India for manufacturing and marketing Lobeglitazone based on a randomised, double‐blind Phase 3 clinical trial conducted on adult Type 2 diabetic patients, aged 18 years and older. The results of this trial have shown a faster and improved glycemic control with Lobeglitazone. According to IQVIA sales data for the 12‐month period ending Aug 2022, the market for oral anti‐diabetic drugs in India is estimated to be Rs 11,725 crore. with an annual growth of 7% against the corresponding period last year (MAT Aug 2021). As per the International Diabetes Federation (IDF), the prevalence of diabetes in India is expected to increase to 125 million by 2045. Out of these, 77% of patients have uncontrolled diabetes. Moreover every four out of ten diabetic patients seem to have insulin resistance in India. ]]> <![CDATA[OncoDynamiX launches cancer treatment solutions in South Asia, Africa, Latin American countries]]> https://biospectrumindia.com/news/95/22060/oncodynamix-launches-cancer-treatment-solutions-in-south-asia-africa-latin-american-countries.html https://biospectrumindia.com/news/95/22060/oncodynamix-launches-cancer-treatment-solutions-in-south-asia-africa-latin-american-countries.html Wed, 05 Oct 2022 11:35:00 +0530 Bengaluru-based OncoDynamiX, with an aim to provide tailored treatments and advanced technologies for cancer treatment, will help global patients from Southeast Asia, Africa, and Latin America to get information on getting screened for cancer, survival rates of different cancers, diagnosis tips, and more.   OncoDynamiX uses two platforms to target cancer treatment. NEOTOX is a novel, novel data-driven methodology for pragmatic precision medicine, which is a non-next generation sequencing (NGS) route to personalised cancer therapy. The technology predicts the clinical outcome of a cancer patient to specific cancer to specific drug or combination of drugs and validates in a 3D environment in the lab before summarising to each patient.   ONCEMBLEX is a genomics-driven methodology for precision medicine in cancer. The workflow utilises cutting-edge protocols in NGS for an exhaustive set of genes relevant to cancer– be it known, targetable signatures, or drivers and passengers of unknown significance. The technology enables to pinpoint the best drug or combination of drugs with maximum therapeutic benefit. ]]> <![CDATA[Medicamen forays in domestic pharma business]]> https://biospectrumindia.com/news/95/22056/medicamen-forays-in-domestic-pharma-business.html https://biospectrumindia.com/news/95/22056/medicamen-forays-in-domestic-pharma-business.html Mon, 03 Oct 2022 16:05:00 +0530 New Delhi-based Medicamen Biotech is foraying into domestic business with its subsidiary Medicamen Life Sciences Pvt Ltd. While issuing the press release, Medicamen group chairman Mr. According to Rahul Bishnoi, Medicamen group Chairman, “The vision of the company is to become a most admired pharmaceutical organization by offering research & data backed, affordable & quality medicines for Indian population and to start with, the company has entered cardio-vascular & diabetes (CVD) business, which contributes annual revenue of more than Rs 50000 crore to the Indian pharma market with a CAGR of 11%”. "Kamal Pahwa, a pharma veteran with 32 years of experience in CVD business and Pramod Sharma of Neelkanth Drugs, a leading distribution network in India, have joined hands with Medicamen to launch this very ambitious venture", said Bishnoi. Medicamen Biotech was established in 1996, and till now has been focusing on international business. It has recently commenced its state of the art oncology plant at Haridwar which is meant for regulated market like US and Europe. Medicamen earlier this year had launched its high-quality oncology products in the domestic market. ]]> <![CDATA[Is Post-COVID Derma Sector Booming?]]> https://biospectrumindia.com/features/95/22029/is-post-covid-derma-sector-booming.html https://biospectrumindia.com/features/95/22029/is-post-covid-derma-sector-booming.html Sat, 01 Oct 2022 01:00:00 +0530 For years, India has been home to a number of skin conditions and diseases such as acne, psoriasis, dermatitis, vitiligo, fungal and bacterial infections, to name a few. Although mortality due to skin diseases is low, they contribute to significant disability and stigma. Most of the data on the epidemiology of skin diseases from India is in the form of small case series or surveys from hospitals or communities and it does not give us the true picture of disease burden in the country. For instance, conditions like psoriasis pose a financial burden along with psychosocial consequences due to the stigma attached to them. Thus, these skin problems are often neglected and people refrain from going to the doctor or end up doing self-treatment. In addition, the anti-infectives, cardiac and diabetes segments have been known to dominate the Indian pharmaceutical market, leaving very little space for the dermatology segment to grow and carve a niche for itself. The good news, however, is that things are looking up for dermatology. According to a recent AWACS AIOCD report, the segment has increased to 30 per cent in May 2022 (in moving annual turnover). The report has revealed that the segment is valued at Rs 11,043 crore in May 2022, and it looks to be one of the fastest growing therapies going forward. This spike in dermatology drug sales is a result of the increase in demand for anti-acne, emollients, anti-fungal and skin brightening formulations, as people are resuming their normal activities.  “The dermatology sector in India is set to boom as people are facing factors such as lifestyle changes, environmental changes, pollution, and also short term factors like heat, humidity and pollution as they resume their daily activities as pandemic-led concerns subside. We see this opportunity as promising and are happy to boost supplies of novel dermatological medicines to allay the increasing skin complaints. We also hope to capture a larger market share for being the pioneers in dermatology manufacturing, by having a vast array of products both through our R&D and in-licensed collaborations”, says Sanjeev Jain, Founder, Promoter and Director, Akums Drugs & Pharmaceuticals. Backing this trend is an observation by Bengaluru-based healthcare platform MediBuddy that has witnessed a manifold rise in dermatology consultations. Data compiled reveals that in the last few months, the portal has seen an overall growth of about 84 per cent in the number of people seeking consultations for skin-related issues. “About 69.47 per cent of issues were relating to acne, with the rest pertaining to problems like pigmentation, face tan, generic skin disease, ringworm, psoriasis, etc. The data on the platform also reveals that of the total people who sought consultations about 75.9 per cent of people were males. Men and women are both susceptible to dermatological issues and our data shows that men are also increasingly seeking professional help for dermatological issues rather than ignoring them”, says Satish Kannan, Co-Founder and Chief Executive Officer, MediBuddy.   Pharma ups the game The increasing prevalence of skin conditions, both infectious and non-infectious, has boosted the pharma companies to manufacture medications thereby increasing their R&D activities. For example, Mumbai-based Sun Pharmaceutical is currently conducting phase-2 clinical trials for a potential oral treatment for atopic dermatitis and moderate to severe plaque psoriasis. On the other hand, Mumbai-based Glenmark Pharmaceuticals has recently launched India’s first topical Minocycline 4% Gel for the treatment of moderate to severe acne, under the brand name MINYM. In a study conducted by Glenmark in 2020, on the prevalence of acne in India, it was observed that 45 per cent of the patients were males and 55 per cent were females; and almost 72 per cent of the patients were in the adolescent group whereas 27 per cent patients were in the adult group. Pune-based Ahammune Biosciences has emerged as the first drug discovery company in the country to develop a targeted new treatment option for vitiligo. With the transition to the human clinical stage, the company has now developed a space for itself in this domain and is now being approached by stakeholders for possible collaborations. Sharing more insights about the new dermatology drug under development, Dr Parul Ganju, Co-Founder and Executive Director, Ahammune Biosciences says, “Our first new chemical entity has been developed for the treatment of skin depigmenting disorder, vitiligo. With a first in class mechanism of action, this is one of the first targeted treatments to be developed for the disease which affects millions of patients throughout the world. This drug candidate is currently in Phase I clinical trials. All our data establishes that AB1001 is very safe in humans when tested in highest concentrations.” Ahmedabad-based Uniza Healthcare is another player focusing on vitiligo treatment by launching a lotion Vitellus in collaboration with a Canadian company Lucas Meyer Cosmetics and Indian company Mumbai-based Amvigor Organics.  The product comprises of ingredients such as Greyverse that stimulates melanogenesis and pigmentation and decreases in oxidative stress; Melitane that helps in promoting re-pigmentation of skin by stimulating melanogenesis and decreasing inflammation.  Cadila Pharma, based in Ahmedabad, is also investing in developing new products in dermatology. Its latest development comes in the form of Laglo Soft Lotion for treating dry skin conditions. It is proven to be effective in treating skin conditions such as xerosis, ichthyosis, atopic dermatitis, psoriasis and skin ageing. According to Praveen Sikri, Chief Executive Officer, Ikris Pharma Network, "Like all segments, developing solutions for skin-related conditions has its own unique challenges for pharma players. While seeking to address the dermatological or pathological aspects of a condition, makers of skin products also have to be mindful of the cosmetic side of the treatment. So, sometimes a certain formulation may be effective in treatment of the underlying condition but may not be cosmetically or aesthetically advisable. Therefore, selection of the right raw material and the ingredients in order to prepare a certain formulation is very critical.”  Another major pharma player in the dermatology segment is Vadodara-based Alembic Pharmaceuticals that has recently acquired 100 per cent stake in Aleor Dermaceuticals from its joint venture partner Orbicular Pharmaceutical Technologies (Orbicular) to strengthen its skin-related manufacturing and marketing footprint.   Using technology for assistance Besides developing new medications for various skin conditions, pharmaceutical firms are also exploring the use of technology for better diagnosis and treatment. For instance, Glenmark Pharmaceuticals has launched a digital patient education tool 'Hello Skin' in collaboration with the Indian Association of Dermatologists, Venereologists and Leprologists, to help patients suffering from Dermatophytosis (Ring Worm or Tinea) in India, and to adhere to the recommended treatment duration. Likewise, Janssen Pharmaceutical Companies of Johnson & Johnson has announced the launch of icare4u, a comprehensive digital programme to support the physical and mental health of people suffering from psoriasis and other skin conditions. Further, a number of startups have entered the dermatology segment with new technologies to detect skin diseases. An artificial intelligence (AI) driven smartphone app- DermaAId has been launched by New Delhi-based startup Nurithm Labs to address the access and accuracy problems in clinical diagnosis of dermatological diseases, including skin cancer. DermaAId can identify more than 50 skin diseases with about 80 per cent accuracy. Then, there is Bengaluru-based startup CureSkin that enables users to take photos and instantly get AI analysis for acne, dark spots, pigmentation, wrinkles, and others for free. The startup has so far raised funding worth $5.5 million. Another breakthrough in these times of digital expansion is the Fibon app backed by real dermatologists, unlike the AI model used by similar competitors. The dire need for Fibon arose for two reasons: dermatologists not being easily accessible and the possibility of diagnosing the majority of skin disorders at a glance and symptoms of a patient. With the transition from 2022 to 2023 and things shifting their focus to digital mediums, a phone app is probably making all the difference in people’s lives. “One of the limitations to the dermatology market's expansion is the shortage of dermatology specialists, but this problem can be resolved by online doctor consultations for patients all over the world. The dermatology market is anticipated to increase significantly in the coming years because of changing lifestyles, and easy access to dermatology products in less time and at a lower cost through e-commerce”, says Karan Chechi, Research Director, TechSci Research. The digital tools being developed by the industry are indeed putting the spotlight on the awareness of various infectious and non-infectious skin diseases in the country, but there is also a need to give due importance to this segment in the national health policies. Although there is no direct estimate of the socio-economic burden of skin diseases in a country like India, it is high time that we stop ignoring them.   Sakura Koner   ]]> <![CDATA[Krsnaa Diagnostics to launch 600 new centres & foray into retail healthcare services]]> https://biospectrumindia.com/news/95/22030/krsnaa-diagnostics-to-launch-600-new-centres-foray-into-retail-healthcare-services.html https://biospectrumindia.com/news/95/22030/krsnaa-diagnostics-to-launch-600-new-centres-foray-into-retail-healthcare-services.html Wed, 28 Sep 2022 12:00:00 +0530 Pune-based Krsnaa Diagnostics has announced its plans to launch 600 diagnostics centres across India. The company will strengthen its footprint across Maharashtra, Himachal Pradesh, Punjab, West Bengal, and Rajasthan, with the spread across metros, tier 2 and tier 3 cities. The centres will be equipped to offer specialized services in precision medicine, genetics, genomics, and molecular diagnostics, along with the routine investigations of biochemistry and serology, which are commonly used in routine diagnostics tests. The centres will offer dedicated services for women’s health (hormones/ PCOD), diabetes monitoring, cardiac health, and cancer care.  Currently, the company is present in 16 states and 2 Union Territories of India with 2,000 plus locations.  Sharing the company’s vision, Pallavi Jain, Managing Director of Krsnaa Diagnostics said, “Considering the rising demand for diagnostics services and to cater to the remotest parts of the country, we have decided to enter deep markets through a franchise model. With this expansion, we wish to take the high-end infrastructure and best-in-class diagnostics services to more people across the country.” ]]> <![CDATA[Dr. Reddy’s deploys IQVIA Orchestrated Customer Engagement platform]]> https://biospectrumindia.com/news/95/22024/dr-reddys-deploys-iqvia-orchestrated-customer-engagement-platform.html https://biospectrumindia.com/news/95/22024/dr-reddys-deploys-iqvia-orchestrated-customer-engagement-platform.html Wed, 28 Sep 2022 09:05:00 +0530 IQVIA has announced that Hyderabad-based pharmaceutical firm Dr. Reddy’s Laboratories has selected IQVIA Orchestrated Customer Engagement (OCE) platform as its core customer relationship management (CRM) solution for its entire field force in India. Mukesh Rathi, Global Chief Digital and Information Officer, Dr. Reddy’s Laboratories said, “OCE will help streamline our field processes and in-clinic customer interactions, while driving productivity, and improving our field team’s experience with digital tools.” Under the terms of this multi-year agreement, Dr. Reddy’s will rollout IQVIA’s OCE application to its entire field force and marketing users in India to drive more meaningful and impactful customer engagement by seamlessly linking marketing, sales, medical science liaison, account management, and other functions. OCE is IQVIA’s CRM Application Suite that enables life sciences clients to digitally transform their sales and marketing operations. Powered by IQVIA Connected Intelligence, OCE provides role-specific intelligent workflows that improve decision making and make HCP engagement smarter, faster, and more convenient. The OCE suite is a highly configurable and scalable SAAS based CRM solution which is built on best-in-class platforms, such as Salesforce.com, Mulesoft, Amazon Web Services, Heroku, and Box. Currently, more than 190 life sciences companies worldwide successfully use OCE as their flagship CRM system. The platform provides a scalable, standardized solution that meets local requirements as well as global ones, besides providing near real time in-clinic and field analytics. IQVIA has set up a dedicated team and delivery center in Bangalore to assist pharma companies, including those in India, in leveraging these solutions.  ]]> <![CDATA[Bayer brings new treatment option for chronic heart failure patients in India]]> https://biospectrumindia.com/news/95/22019/bayer-brings-new-treatment-option-for-chronic-heart-failure-patients-in-india.html https://biospectrumindia.com/news/95/22019/bayer-brings-new-treatment-option-for-chronic-heart-failure-patients-in-india.html Tue, 27 Sep 2022 12:00:00 +0530 Bayer has announced the launch of vericiguat (Verquvo), a soluble guanylate cyclase (sGC) stimulator, in India. Vericiguat is indicated, along with guideline-based medical therapy, in adults with symptomatic chronic heart failure with reduced ejection fraction (less than 45%), following a recent event of worsening heart failure which required hospitalization or outpatient intravenous (IV) diuretics. Vericiguat works on a pathway not currently targeted by existing heart failure treatments and can reduce the risk of cardiovascular death and heart failure hospitalization in such patients. Manoj Saxena, Managing Director, Bayer Zydus Pharma, says, “Despite therapy, chronic heart failure patients can experience disease progression that disrupts their lives and leads to worsening heart failure events, where hospitalization or initiation of intravenous diuretics are needed. After an event of worsening heart failure, more than 50% of patients may require re-hospitalization within 30 days. The in-hospital mortality rate in India is also high and registry data suggest that it ranges between 10–30.8% as compared with 4–7% in Western countries. Verquvo can help patients stay out of the hospital and improve the chances of survival in such patients.”  Vericiguat is currently approved for use in 35 countries including the United States, European Union countries, the United Kingdom, Japan and Singapore. Vericiguat is the only treatment that has been recommended following a worsening heart failure event, on top of foundational heart failure therapies in major international guidelines Verquvo will be made available to address the needs of HF patients in India at an India-specific price, almost at the same time as HF patients in around the world.     ]]> <![CDATA[IVD firm Holborn Wells India launches regulatory affairs consulting division]]> https://biospectrumindia.com/news/95/22015/ivd-firm-holborn-wells-india-launches-regulatory-affairs-consulting-division.html https://biospectrumindia.com/news/95/22015/ivd-firm-holborn-wells-india-launches-regulatory-affairs-consulting-division.html Tue, 27 Sep 2022 10:00:00 +0530 Holborn Wells India, an in-vitro diagnostics (IVD) manufacturing company, has launched a Pharmaceutical & Medical Devices Regulatory consulting division to assist local startups and consult foreign companies looking to invest in India in the pharma and medical device sector.   Over the last few months, Holborn Wells India had multiple queries from various Indian startups as well as from Europe & North America related to the regulatory landscape and setting up a manufacturing base in India.   The company is not only able to assist with documentation as per CDSCO guidelines, but with the extensive technical and regulatory experience as a medical device manufacturer, The company can deliver end-to-end services including technical, legal and contract manufacturing services through the channel partners. The intent is to assist the nation in attracting Foreign Direct Investments and act as a catalyst to support 'Start-up India' initiative set up by Prime Minister Narendra Modi.     ]]> <![CDATA[DFPCL launches range of hand and surface disinfection solutions for healthcare sector]]> https://biospectrumindia.com/news/95/22018/dfpcl-launches-range-of-hand-and-surface-disinfection-solutions-for-healthcare-sector.html https://biospectrumindia.com/news/95/22018/dfpcl-launches-range-of-hand-and-surface-disinfection-solutions-for-healthcare-sector.html Tue, 27 Sep 2022 06:00:00 +0530 Deepak Fertilisers And Petrochemicals Corporation Ltd. (DFPCL) has announced the launch of Cororid disinfection solutions designed to cater to the specific needs of hospitals, clinics, laboratories, and other medical and healthcare set-ups. Cororid® is a certified, high-quality Iso Propyl Alcohol (IPA) based formulation that is the world’s most preferred active ingredient in hand sanitizers and other disinfection products. With global organisations such as WHO and CDC stressing the role of IPA in fighting off various microorganisms, DFPCL’s Cororid Disinfection Solutions range has been designed to meet stringent industry standards and is amongst the very few fortified with Indian Pharmacopoeia (IP) grade IPA. Through the launch of this product range, DFPCL aims to further strengthen its market presence in speciality chemicals to meet the demands of the pharma and medical community.   ]]> <![CDATA[Alkem Labs unveils new initiative to spread awareness on lung health]]> https://biospectrumindia.com/news/95/22021/alkem-labs-unveils-new-initiative-to-spread-awareness-on-lung-health.html https://biospectrumindia.com/news/95/22021/alkem-labs-unveils-new-initiative-to-spread-awareness-on-lung-health.html Tue, 27 Sep 2022 04:00:00 +0530 Understanding the dire need for lung health awareness, Mumbai-based Alkem Laboratories has pledged to spread awareness through its initiative “The Healthy Lungs”. The Healthy Lungs portal (www.thehealthylungs.com) acts as an experience-sharing platform for patients with access to the patient community. Under this initiative, the patients also get access to virtual educators, on-ground camps, and doctor talks to learn about diseases and accurate inhaler techniques. Exposure to multiple irritants such as dust, chemicals, and smoke, make lungs susceptible to diseases like chronic obstructive pulmonary disease (COPD) and asthma. Respiratory diseases are the second most common cause of death after heart disease. The global burden of disease (GBD) report highlighted COPD is the second leading cause of death and disability in India. Out of the chronic respiratory disease burden in India, COPD accounts for over 50% of the disease burden and 70% of the years of life lived with disability. Crude estimates suggest that India is home to over 55 million COPD patients and 38 million asthma patients. Off late, inhalers have evolved as the most efficient mode of drug delivery for lung disease patients. However, only 10% of patients receive inhalers. Out of this 10%, only 30% of patients take the medicine accurately. For accurate delivery of medicine through inhalers, patients must have access to its right knowledge and technique.   ]]> <![CDATA[Cadila Pharma launches national campaign for rabies-free India by 2030]]> https://biospectrumindia.com/news/95/22008/cadila-pharma-launches-national-campaign-for-rabies-free-india-by-2030.html https://biospectrumindia.com/news/95/22008/cadila-pharma-launches-national-campaign-for-rabies-free-india-by-2030.html Sat, 24 Sep 2022 00:00:00 +0530 Ahmedabad-based Cadila Pharmaceuticals and the premier industry body Confederation of Indian Industry (CII), at Delhi, have launched a joint national campaign for a rabies-free India by 2030. The campaign was launched at the 4th CII Life Sciences Conclave in New Delhi on 23 September. Attended by top leaders from the pharma industry, senior government officials, and policymakers, the Conclave was organised to brainstorm on developing a well-planned inorganic growth strategy for the life sciences sector. As a part of the campaign to make India rabies-free by 2030, several activities for awareness and prevention of rabies will be undertaken at the national and state level under the aegis of the government of India. Jawed Zia, CEO of Cadila Pharma, says “lack of public awareness and the resultant failure to complete the vaccine regimen are key causes behind rabies deaths.” Rabies claims around 59,000 deaths globally a year, of which around 20,000 or just over one-third of the deaths take place in India alone. “The key issue is not the loss of lives, but the fact that almost all rabies deaths can be prevented through vaccination. The challenge is awareness and failure to complete the lengthy vaccine regimen, which involves multiple visits to the hospital over several weeks. At Cadila Pharmaceuticals, we have been focusing on preventing rabies deaths, and have recently launched ThRabis, the world’s first three-dose rabies vaccine. The Recombinant vaccine has a simpler regime as compared with other vaccines, and is proving to be a game-changer by helping save many lives,” Dr Manjul Joshipura, Senior VP, New Product Development & Innovations, Cadila Pharmaceuticals, said.   ]]> <![CDATA[Pharmaceuticals leads IIFL Wealth Hurun India Rich List 2022]]> https://biospectrumindia.com/news/95/21990/pharmaceuticals-leads-iifl-wealth-hurun-india-rich-list-2022.html https://biospectrumindia.com/news/95/21990/pharmaceuticals-leads-iifl-wealth-hurun-india-rich-list-2022.html Wed, 21 Sep 2022 12:00:00 +0530 Hurun India and IIFL Wealth have released the IIFL WEALTH HURUN INDIA RICH LIST 2022. This is the 11th annual ranking of the richest individuals in India. Wealth calculations are a snapshot as of 30th August 2022. 1,103 individuals are a part of this list, up by 96 from last year, across 122 cities. Cumulative wealth has increased by 9.4%, while average wealth decreased by 1%. 602 individuals saw their wealth increase or stay the same, of which 149 are new faces, whilst 415 saw their wealth drop and there were 50 dropouts. India has 221 billionaires this year down 16 compared to last year. While chemicals and financial services added the greatest number of new entrants to the list, pharma is still at number one and has contributed 126 entrants to the list. The youngest on the list is aged 19, four years younger than the youngest last year. The leaders of the pharma sector highlighted in this list include Dr Cyrus Poonawalla & family (Serum Institute of India), Dilip Shanghvi (Sun Pharma), Murali Divi & family (Divi's Labs), B Parthasaradhi Reddy & family (Hetero Labs), Pankaj Patel & family (Zydus Lifesciences), Samir Mehta- Sudhir Mehta & family (Torrent Pharma), Kiran Mazumdar Shaw (Biocon), Mahendra Prasad (Aristo Pharma), Leena Gandhi Tewari (USV), Yusuf Hamied & family (Cipla) in the top 100. ]]> <![CDATA[HGS Healthcare unveils new brand identity Sagility, post divestment]]> https://biospectrumindia.com/news/95/21964/hgs-healthcare-unveils-new-brand-identity-sagility-post-divestment.html https://biospectrumindia.com/news/95/21964/hgs-healthcare-unveils-new-brand-identity-sagility-post-divestment.html Fri, 16 Sep 2022 11:45:00 +0530 HGS Healthcare, with operations in India, US, Jamaica, and Philippines, has announced 'Sagility' as its new brand identity. The company, a strategic partner for healthcare payers and providers, provides industry-leading technology and transformation-driven business process management (BPM) services. This enables healthcare businesses to deliver efficient and high-quality services to their members.    Speaking on the new brand identity, Ramesh Gopalan, Group CEO, Sagility said, “Sagility means wisdom in action. Sagility will build on this legacy and enhance its service offerings with technology and analytics, thereby enabling the company to offer hi-impact transformative solutions.”   ]]> <![CDATA[US-based health tech firm Modivcare opens CoE in Bengaluru]]> https://biospectrumindia.com/news/95/21956/us-based-health-tech-firm-modivcare-opens-coe-in-bengaluru.html https://biospectrumindia.com/news/95/21956/us-based-health-tech-firm-modivcare-opens-coe-in-bengaluru.html Thu, 15 Sep 2022 00:00:00 +0530 Modivcare Inc., the largest manager of non-emergency medical transportation (NEMT) in the United States, has announced the opening of Modivcare Labs in Bengaluru. The $2.3 billion technology-enabled healthcare services company addresses the social determinants of health (SDoH) by bringing critical patient transportation, remote patient monitoring, meal delivery, and personal in-home care to 34 million patients, or roughly 10 percent of the US population. The Modivcare Labs centre of excellence (CoE) in Bengaluru will build world-class digital platforms and applications to help the most vulnerable and underserved US patient population access quality, life-saving care. This will be achieved in Bengaluru by utilizing emerging technologies in data science, artificial intelligence (AI), machine learning (ML), Internet of Things (IoT), Telematics, Blockchain, and Big Data to create innovative, digital services for patient transportation, meal delivery, and in-home care. These intense intellectual exercises are being carried out in Modivcare Labs to provide on-time performance and a rich user experience for patients. Developing these advanced, digital technology-enabled services will require recruiting local, top-tier talent for Modivcare Labs in Bengaluru. Approximately 200 positions in digital platform development and support will be offered to applicants with advanced degrees in engineering and science with extensive experience serving as senior engineering leaders, data scientists, senior software developers, and architects in Java stack and Python stack, React, Angular, and Native App developers. This would include Quality Assurance automation testers focused on automation, ServiceNow developers to improve workflows and automation, Network Engineers, Cloud Engineers, Sr. NOC and SOC analysts for keeping systems highly available and reliable, and Product managers to improve product features and capabilities.  ]]> <![CDATA[AstraZeneca launches iPHARMACY to up-skill pharmacists across India]]> https://biospectrumindia.com/news/95/21953/astrazeneca-launches-ipharmacy-to-up-skill-pharmacists-across-india.html https://biospectrumindia.com/news/95/21953/astrazeneca-launches-ipharmacy-to-up-skill-pharmacists-across-india.html Wed, 14 Sep 2022 17:50:00 +0530 AstraZeneca India has launched its up-skilling programme for pharmacists, iPHARMACY. In the first phase of the programme, the company has partnered with Neethi, a Kerala state cooperative consumers federation limited company, to run this programme in Kerala. As a next step, the company is planning to collaborate with large pharma-retail chains from across India to expand this programme to other parts of the country.    The programme will focus on inventory management, good pharmacy practices, customisation of pharmacy for the patient of future, and management of pharmacy during covid. The content and modules for the programme are created by the team of experts from AstraZeneca and their partners, which will equip pharmacists across India to provide standardised and quality counselling, and support to the people.    AstraZeneca India has chosen Moodle as the learning platform to run this course. The entirety of the course module will take place digitally. The pre-requisite for every participant would be to register themselves, and subsequently, a unique credential would be created for every individual to run the course. This e-learning mobile compatible programme has four modules which can be completed at one’s own pace. The programme will remain active till the end of this year for the pharmacists from Neethi. The course can be completed within this period, where each student will be awarded a completion certificate by the European body of CME/CPD Academy. The total number of participants from Neethi at this phase would be around 200.       ]]> <![CDATA[Zenara Pharma launches first generic of Paxlovid for COVID-19 in India]]> https://biospectrumindia.com/news/95/21932/zenara-pharma-launches-first-generic-of-paxlovid-for-covid-19-in-india.html https://biospectrumindia.com/news/95/21932/zenara-pharma-launches-first-generic-of-paxlovid-for-covid-19-in-india.html Fri, 09 Sep 2022 13:35:00 +0530 Hyderabad-based Zenara Pharma, a fully-owned subsidiary of Biophore India Pharmaceuticals, has launched Nirmatrelvir and Ritonavir tablets in a combi pack as a treatment option for patients with mild to moderate symptoms of COVID-19. It is to be noted that Zenara Pharma received approval from the Central Drugs Standard Control Organization (CDSCO) to manufacture and market this product last month. The tablet, which will be sold under the brand name ‘Paxzen’, is being manufactured at Zenara’s US FDA and EU-approved state-of-the-art facility in Hyderabad. The product will be sold at a maximum retail price of Rs 5,200 per box, equivalent to one full course of treatment per patient, and contains 20 Tablets of Nirmatrelvir 150 ml and 10 tablets of Ritonavir 100 mg. ]]> <![CDATA[Siemens Healthineers inks partnerships with IISc, HealthCare Global and Narayana Health]]> https://biospectrumindia.com/news/95/21936/siemens-healthineers-inks-partnerships-with-iisc-healthcare-global-and-narayana-health.html https://biospectrumindia.com/news/95/21936/siemens-healthineers-inks-partnerships-with-iisc-healthcare-global-and-narayana-health.html Fri, 09 Sep 2022 12:00:00 +0530 Siemens Healthineers has announced strategic partnerships with the Indian Institute of Science (IISc), HealthCare Global Enterprises (HCG), and Narayana Health (NH). These partnerships are big steps in making India an innovation centre for Siemens Healthineers globally. The company continues to build on its committed investment of Rs 1,300 crore (€160 million) to establish a new campus housing research and development, manufacturing, and sales, and an innovation centre.  The collaboration with the Indian Institute of Science (IISc) aims to drive research and co-creation of technologies that improve imaging, and address access to care. Speaking about the partnership, Prof. Govindan Rangarajan, Director, IISc said, “As IISc is opening up a new frontier of clinical research with the establishment of the IISc Medical School and Bagchi-Parathasarathy Hospital, this partnership with Siemens Healthineers will strengthen our focus in integrating science, engineering and medicine. This partnership will also enable our researchers to invent technologies for better and affordable healthcare outcomes.“ Further, Narayana Health's partnership with Siemens Healthineers will focus on advancing cardiovascular care and digital transformation in healthcare by building on the capabilities from both organizations.  The partnership with HealthCare Global Enterprises aims to make cancer care more personalized through the application of diagnostic imaging technologies and artificial intelligence.    ]]> <![CDATA[Zydus in-licenses critical drug for CKD patients from Denmark-based Pharmacosmos]]> https://biospectrumindia.com/news/95/21935/zydus-in-licenses-critical-drug-for-ckd-patients-from-denmark-based-pharmacosmos.html https://biospectrumindia.com/news/95/21935/zydus-in-licenses-critical-drug-for-ckd-patients-from-denmark-based-pharmacosmos.html Fri, 09 Sep 2022 09:00:00 +0530 Ahmedabad-based Zydus Lifesciences has acquired rights to market MonoFerric (iron isomaltoside) injections in India and Nepal from Denmark-based Pharmacosmos A/S. MonoFerric , iron isomaltoside 1000 solution for injection/infusion, is a rapid, single dose IV iron (up to 20 mg/kg bodyweight) developed to reduce the number of infusions required to achieve iron correction with an excellent safety profile. It is indicated for the treatment of iron deficiency in adult patients when oral iron preparations are ineffective or cannot be used or where there is a clinical need to deliver iron rapidly. MonoFerric is available in over 30 countries including US and Europe and over 28 million doses have been administered since launch. Speaking on the development Dr Sharvil Patel, Managing Director, Zydus Lifesciences Ltd. said, “Iron Deficiency is a severe healthcare challenge and also impacts the quality of life more so in chronic kidney disease (CKD) patients. With this introduction, we bring a novel solution to these patients and with our strong lastmile delivery, we will enable access to this critical therapy.” Zydus is amongst the top players in the Nephrology segment with a super-specialty portfolio with brands like Oxemia, Zyrop, Renocrit, Kbind, Grafalon, Tacromus and Mycomune. ]]> <![CDATA[ENTOD Pharma launches snake venom based facial gel serum ]]> https://biospectrumindia.com/news/95/21927/entod-pharma-launches-snake-venom-based-facial-gel-serum-.html https://biospectrumindia.com/news/95/21927/entod-pharma-launches-snake-venom-based-facial-gel-serum-.html Thu, 08 Sep 2022 13:00:00 +0530 Entod Beauty London, a dermatological venture of Mumbai-based Entod Pharmaceuticals, has launched its Facial Gel Serum known as "Vasuki" in India. This  Facial Gel Serum is one of the world’s first clinically proven synthetic tripeptidesnake venom neurotoxin developed by the advanced skincare laboratories of Entod Research Cell UK Ltd.  Based on a patented anti-ageing synthetic tripeptide snake venom neurotoxin developed by the Swedish company, Pentapharm Ltd., this nanotechnology-based facial gel serum is a winner of the Swiss Technology Awards.  "While many people probably think that snake venom is harmful, it actually can produce anti-ageing benefits when applied topically to the skin. Some are even of the opinion that the results are better than Injectable neurotoxins! Through years of research, it has been found out that snake venom temporarily inhibits muscle activity, which prevents and reduces the appearance of fine lines and wrinkles. Also, it is painless, affordable and relatively hassle-free, which makes it a viable alternative to invasive procedures like lasers and Injectable neurotoxins said Dr Madhulika Mhatre, MBBS,MD,(Gold Medalist), FRGUHS (Aesthetic Dermatology), FMUHS (Trichology).  “We are already achieving a milestone with Vasuki facial gel serum in the European market. We wanted to bring it to India so that our Indian Population can also get the benefits of the latest technology based cosmetic products", said Anjula Masurkar, Clinical Director, Entod Beauty London.   ]]> <![CDATA[Health-tech firm Inovalon's India Development Centre opens in Hyderabad]]> https://biospectrumindia.com/news/95/21926/health-tech-firm-inovalons-india-development-centre-opens-in-hyderabad.html https://biospectrumindia.com/news/95/21926/health-tech-firm-inovalons-india-development-centre-opens-in-hyderabad.html Thu, 08 Sep 2022 12:45:00 +0530 Inovalon, a provider of cloud-based software solutions empowering data-driven healthcare, has inaugurated its India Development Center (IDC) in Hyderabad. With its global technology team based in the US, Inovalon has formally increased its capacity in India to deliver innovation for its customers.For the last eight years, Inovalon has contracted an India-based team to work across the Inovalon enterprise, supporting each of its business units in product engineering and information technology. Effective 1 August 2022, these team members are now fully employed by Inovalon, and the IDC is now the largest single engineering office at Inovalon.Inovalon has partnered with ANSR, a Bengaluru-based firm that helps companies build, manage and scale high-impact global teams, to set up the IDC in Hyderabad.  "The Inovalon ONE® Platform brings together solutions from across the technology ecosystem, and the Hyderabad center is uniquely positioned to help drive that collaboration. We expect to utilize the IDC to continue to increase the team by 15% in size to support growth in capabilities and collaboration," said Sanjay Kumar, Vice President, Technology, Inovalon, and head of the India Development Center. ]]> <![CDATA[IIT-K inks MoU with NAPL for hemp-based medicinal research]]> https://biospectrumindia.com/news/95/21904/iit-k-inks-mou-with-napl-for-hemp-based-medicinal-research.html https://biospectrumindia.com/news/95/21904/iit-k-inks-mou-with-napl-for-hemp-based-medicinal-research.html Fri, 02 Sep 2022 12:30:00 +0530 The Indian Institute of Technology-Kanpur (IIT-K) has collaborated with Niche Agriculture & Pharmaceuticals Limited (NAPL) for research in the field of hemp cultivation and formulation of advanced medicines for treating chronic medical conditions.   The collaboration between the two parties will focus on research, development, and consultancy studies in the fields of mutual interest. By partnering together, the IIT-K and NAPL are setting the groundwork for reorganising the indigenous cannabis plant and creating new hemp cultivars that adhere to international regulations. The development of new hemp-based treatments will help doctors address the rising rates of cancer, epilepsy, migraine, chronic pain, arthritis, and insomnia in India.   The MoU was signed by Prof Abhay Karandikar, Director, IIT Kanpur, and Harisharan Devgan, Chairman of Niche Group of Companies, in the presence of esteemed Senior Professors, researchers, and other faculty members. The MoU also focuses on the exchange of academic materials and publications and extends to formulating hemp-based and other medicines for chronic diseases. ]]> <![CDATA[Merck opens R&D Excellence Centre in Bengaluru]]> https://biospectrumindia.com/news/95/21900/merck-opens-rd-excellence-centre-in-bengaluru.html https://biospectrumindia.com/news/95/21900/merck-opens-rd-excellence-centre-in-bengaluru.html Thu, 01 Sep 2022 17:55:00 +0530 Merck has opened a Healthcare R&D Excellence Centre facility in Bengaluru. The centre will contribute to the company’s Healthcare Research & Development (R&D) ambition of delivering the health care remedies of tomorrow, that can help treat patients with unmet medical needs around the world.   The R&D Excellence Centre aims at promoting innovation in the scientific community to improve healthcare solutions around the globe. Since 2020 the Excellence centre has onboarded around 300 employees and will continue its expansion over the next two years.   Suneela Thatte, VP and Head R&D Excellence Centre said, "The centre in Bengaluru aims to establish a one-team culture, delivering critical responsibilities in the drug development journey as well as developing a valuable talent pool. The R&D Excellence Centre strives to bring the best of global practices and local talent to enable the vision of enhanced patient outcomes."   Presently, the centre constitutes six different functions: • Global Regulatory Affairs (GRA) • Global Patient Safety (GPS) • Global Development Operations (GDO) • Strategy, Portfolio & Innovation (SP&I) • Global Scientific Exchange and Communication (GSEC) • Global Biostatistics Epidemiology and Medical Writing (GBEM) ]]> <![CDATA[Dr Reddy's, Aurigene Pharma ink MoU with DNDi to develop drugs for NTDs]]> https://biospectrumindia.com/news/95/21894/dr-reddys-aurigene-pharma-ink-mou-with-dndi-to-develop-drugs-for-ntds.html https://biospectrumindia.com/news/95/21894/dr-reddys-aurigene-pharma-ink-mou-with-dndi-to-develop-drugs-for-ntds.html Thu, 01 Sep 2022 08:30:00 +0530 Dr Reddy’s Laboratories and Aurigene Pharmaceutical Services have announced a Memorandum of Understanding (MoU) with the Drugs for Neglected Diseases initiative (DNDi), a not-for-profit research and development organisation.The parties will explore a potential collaboration to develop and market novel and improved drugs for the treatment of identified Neglected Tropical Diseases (NTDs) of national and global importance. The parties will also seek to work towards ensuring access of those drugs at affordable prices to patients in need particularly in Low and Middle-Income Countries (LMICs) that are disproportionately affected by these NTDs. The potential partnership will aim to bring DNDi’s expertise in NTDs together with the scientific, technical and commercial capabilities of Aurigene and Dr Reddy’s – access to a pipeline of new chemical entities, pre-clinical studies, network and advocacy on these NTDs by DNDi; phase-wise clinical studies, research and development, commercial manufacturing of the Active Pharmaceutical Ingredients (API) and the finished products by Aurigene; distribution and commercialisation of the drugs by Dr Reddy’s. ]]> <![CDATA[Driving Up Drug Discovery]]> https://biospectrumindia.com/features/95/21875/driving-up-drug-discovery.html https://biospectrumindia.com/features/95/21875/driving-up-drug-discovery.html Thu, 01 Sep 2022 00:00:00 +0530 On July 5, Aurigene Discovery Technologies, a clinical stage biotech company committed to bringing novel therapeutics for the treatment of cancer and inflammation and a wholly owned subsidiary of Dr. Reddy’s Laboratories has announced drug discovery, development and commercialisation partnership with EQRx, which operates as a biotechnology company in the US, focused on re-engineering the process from drug discovery to patient delivery with the goal of offering a market-based solution for the rising cost of medicines.  The partnership combines Aurigene’s small molecule drug discovery platform and EQRx's pioneering business model to accelerate the development of drug candidates in the areas of oncology and immune-inflammatory diseases and improve global access to innovative medicines. Based in Bengaluru and Kuala Lumpur, Aurigene has developed deep expertise in cancer and inflammatory disorders, and has continuously invested in its people resources and infrastructure over the years. In the two decades of working with pharma, biotech and academic partners, Aurigene has contributed to delivering 16 small molecule and peptide drug candidates, currently in clinical development. Aurigene has also out-licensed several first-in-class and best-in-class compounds to pharma and biotech companies for global clinical development, while undertaking clinical POC studies for a few programmes on its own.  Besides Aurigene, many other large and small companies have been spending on drug discovery and development research using the latest available Information Technology tools such as artificial intelligence (AI) and machine learning (ML).  In February this year Excelra, Hyderabad-based company specialises in Algorithms, Biomarker Discovery, Drug Discovery, Drug Repurposing, Immuno Oncology, Knowledgebase has entered into a collaboration with X-Chem, a leader in small molecule drug discovery services for pharmaceutical and biotech companies to accelerate preclinical drug discovery and aid scientists to find new drug candidates for currently hard-to-drug targets.  This synergistic new partnership between Excelra's GOSTAR and X-Chem's RosalindAI will enable unique and powerful tools to predict small molecules, chemical, biological, and physical properties, accelerating time and resource-intensive stages of drug discovery from hit identification to preclinical candidate selection.  Excelra noted that the GOSTAR's proprietary data set underwent rigorous analysis and large-scale machine learning model building to predict drug solubility in a recent joint study. X-Chem's RosalindAI delivered superior and actionable results than other similar analyses using well-known publicly available datasets. The results confirmed that RosalindAI's proprietary models are designed specifically to address challenges in chemical datasets, and when trained on the larger, more diverse GOSTAR data, yielded models twice as better than models trained on other datasets. Adding to the list of collaboration between public and private firms in the drug discovery space is KnowDis and IIT Delhi as both have collaborated to accelerate drug discovery using AI. The collaboration aims to develop cutting-edge AI models that could discover potential antibodies essential for treating brain diseases. KnowDis noted that the collaboration aims to develop an algorithm that will predict, with high-throughput, antibodies effective in treating neurodegenerative diseases such as Alzheimer’s disease and Parkinson’s.  This will result in drugs becoming more affordable as it will lead to quicker development of effective therapies for dementia, and Alzheimer’s disease, reducing the long wait for treatment.  The process of designing and producing antibodies is time-consuming and expensive but an algorithm can add value to channelling laboratory work. On the other hand DFE Pharma, a global leader in pharma- and nutraceutical excipient solutions, announced the launch of its new Center of Excellence “Closer to the Formulator” (C2F) in Hyderabad. The C2F center helps pharmaceutical companies to shorten the time from a concept to a finished commercial product through expertise in all phases of pharmaceutical development.   Click here to read the full story..... ]]> <![CDATA[Zydus starts Ph IV trial for Desidustat in patients with CKD induced anaemia]]> https://biospectrumindia.com/news/95/21891/zydus-starts-ph-iv-trial-for-desidustat-in-patients-with-ckd-induced-anaemia.html https://biospectrumindia.com/news/95/21891/zydus-starts-ph-iv-trial-for-desidustat-in-patients-with-ckd-induced-anaemia.html Tue, 30 Aug 2022 17:50:00 +0530 Ahmedabad-based Zydus Lifesciences has announced the commencement of Phase IV clinical trial for Desidustat in patients with Chronic Kidney Disease (CKD) induced anaemia. CKD is predicted to become one of the most common causes of premature death by 2040 globally. It is estimated that 115.1 million people in India.The Phase IV DREAM-CKD trial will enrol 1004 CKD patients in India, including 502 dialysis-dependent and 502 dialysis-independent CKD patients with anaemia. This multicentre post-marketing surveillance study will evaluate the safety of Desidustat for the treatment of anaemia in subjects with chronic kidney disease for 52 weeks. Desidustat has been previously studied in randomised controlled clinical trials in over 1200 CKD patients, and is currently approved in India as OxemiaTM for the treatment of anemia in Chronic Kidney Disease (CKD) patients. ]]> <![CDATA[ICPA launches anti-ulcer dental paste for mouth ulcers]]> https://biospectrumindia.com/news/95/21890/icpa-launches-anti-ulcer-dental-paste-for-mouth-ulcers.html https://biospectrumindia.com/news/95/21890/icpa-launches-anti-ulcer-dental-paste-for-mouth-ulcers.html Tue, 30 Aug 2022 17:35:00 +0530 ICPA Health Products (ICPA) has introduced its latest offering – Trioplast, an oral anti-ulcer dental paste for treating mouth ulcers. Triamcinolone acetonide, the main chemical in the paste helps stop or lower the irritation and swelling in the mouth by reducing the reaction to the allergen.   ICPA’s Trioplast is indicated for inflammatory disorders of the mouth, desquamative gingivitis; lesions of the oral mucosa, mucositis, oral sub-mucous fibrosis, recurrent aphthous ulcers, stomatitis and ulcerative conditions associated with pemphigus, pemphigoid, etc.   Trioplast 0.1 per cent oral paste is supplied in a 5 g laminated tube containing 1mg of triamcinolone acetonide per gram of paste.   ]]> <![CDATA[Bayer launches Kerendia to treat CKD in patients with diabetes]]> https://biospectrumindia.com/news/95/21862/bayer-launches-kerendia-to-treat-ckd-in-patients-with-diabetes.html https://biospectrumindia.com/news/95/21862/bayer-launches-kerendia-to-treat-ckd-in-patients-with-diabetes.html Fri, 26 Aug 2022 10:20:00 +0530 German firm Bayer has launched Finerenone under the brand name Kerendia in India. Finerenone is a first-in-class non-steroidal, selective mineralocorticoid receptor antagonist indicated for patients with chronic kidney disease (CKD) associated with type 2 diabetes (T2D).     Finerenone is different to existing CKD in T2D treatments. It acts by blocking mineralocorticoid receptor (MR) overactivation, which is thought to contribute to CKD progression and cardiovascular damage.   The pivotal Phase III clinical trial programme of Finerenone involving more than 13000 patients globally was undertaken to investigate the safety and efficacy of kidney and cardiovascular outcomes in patients with chronic kidney disease associated with type 2 diabetes. The results show that Finerenone significantly reduced the risk of ≥57 per cent Glomerular Filtration Rate (eGFR) kidney composite outcome by 23 per cent on top of optimised Renin-angiotensin system (RAS) blockade, and significantly reduced the risk of the composite CV outcome by 14 per cent.   As per the approval in India, Finerenone is indicated to reduce the risk of sustained Estimated eGFR decline, end-stage kidney disease, cardiovascular death, non-fatal myocardial infarction, and hospitalization for heart failure in adult patients with chronic kidney disease associated with type 2 diabetes. ]]> <![CDATA[Merck India announces 10th Bioforum India 2022]]> https://biospectrumindia.com/news/95/21858/merck-india-announces-10th-bioforum-india-2022.html https://biospectrumindia.com/news/95/21858/merck-india-announces-10th-bioforum-india-2022.html Thu, 25 Aug 2022 00:00:00 +0530 10th Merck Bioforum India 2022 is a thought leadership programme which is a part of the flagship Asia seminar series that Merck Life Sciences has been organizing annually.   This year’s Bioforum India is being hosted in two different cities (on 6th September 2022 in Pune and 8th September 2022 in Ahmedabad) focusing on Next Generation Bioprocessing for Process Intensification.   This is an annual knowledge-sharing platform to build a network of end-users and discuss the evolving future trends of biologics manufacturing processes and technologies, challenges, and process intensification.   While the benefits of next-generation bioprocessing are clear, there are multiple pathways to success and many options across a range of disciplines must be considered. For some applications and biomanufacturers, the focus will be on improving unit operations' interoperability. For others, the goal will be connected or fully continuous processing.   There will be renowned industry experts like Dr Rustom Mody, Senior Vice President & Head R&D Biologics division, Sun Pharmaceutical Industries Ltd., Dr Praveen Gupta, Senior General Manager, Research & Development, Intas Pharmaceutical Ltd., Dr Ashish Sahai, Additional Director, Production (viral vaccines), Serum Institute of India, Dr Ratnesh Jain, Associate Professor, Department of Biological Sciences and Biotechnology, ICT Mumbai along with Merck experts like Dr Subhasis Banerjee, Principal Application Expert, APAC Bioprocessing, Merck KGaA, Dr. Simone Biel, Senior Regulatory Consultant, Merck KGaA etc.     ]]> <![CDATA[US-based CELLINK to establish Centre of Excellence in India for 3D bioprinting]]> https://biospectrumindia.com/news/95/21860/us-based-cellink-to-establish-centre-of-excellence-in-india-for-3d-bioprinting.html https://biospectrumindia.com/news/95/21860/us-based-cellink-to-establish-centre-of-excellence-in-india-for-3d-bioprinting.html Thu, 25 Aug 2022 00:00:00 +0530 CELLINK, the global leader in developing 3D bioprinters, and the Indian Institute of Science (IISc) are partnering to establish a Centre of Excellence (CoE) for 3D bioprinting in Bengaluru, India. The CoE, the first of its kind in the subcontinent, will be housed in the Centre for BioSystems Science and Engineering (BSSE) at IISc, and will provide access to 3D bioprinting systems, enabling researchers to accelerate their work across critical applications, with the ultimate goal of improving health outcomes. An MoU was signed to formalise the collaboration last week. The new CoE will house several state-of-the-art 3D bioprinters from CELLINK and will serve as a hub for several research initiatives and training activities related to this emerging and exciting technology. Prof Govindan Rangarajan, Director, IISc, stated, “The CoE will contribute towards exploring new pathways in 3D bioprinting research and technology development. This would also align very well with the new initiative that we have launched to establish a post graduate medical school at IISc." IISc and CELLINK will work together to conduct workshops aimed at providing researchers within the institute, and elsewhere, the skills necessary to utilise 3D bioprinting in their work and reap the benefits of 3D cell culture. In addition to this, the two will undertake and advise on research projects across multiple applications spanning the fields of tissue engineering, drug discovery, material science and regenerative/personalised medicine. The Centre will have a keen focus on work around the heart, bone, cartilage and cancer. ]]> <![CDATA[Nigeria introduces Bharat Biotech’s ROTAVAC️ vaccine for children]]> https://biospectrumindia.com/news/95/21849/nigeria-introduces-bharat-biotechs-rotavac-vaccine-for-children.html https://biospectrumindia.com/news/95/21849/nigeria-introduces-bharat-biotechs-rotavac-vaccine-for-children.html Wed, 24 Aug 2022 13:50:00 +0530 Bharat Biotech International's rotavirus oral vaccine ROTAVAC️ has been introduced by Nigeria to immunise its children from the life-threatening diarrhoeal disease that affects millions of children worldwide.Dr Krishna Ella, CMD, Bharat Biotech said, “This vaccine is now available in several countries across Asia, Africa, Latin America and the Middle East. Bharat Biotech will continue to play its role in researching, developing, and manufacturing novel vaccines, to lower the morbidity and mortality from infectious diseases and contribute towards the achievement of universal vaccine access."ROTAVAC️ received WHO-Prequalification in January 2018.  Bharat Biotech developed the first generation, rotavirus vaccine, Rotavac under a Public-Private Partnership with the Department of Biotechnology, Government of India and 16 other international partners, making it the largest ever social innovation project for public health. Rotavirus is one of the leading causes of diarrheal disease in the world and is responsible for over 40% of diarrhoea in children. It accounts for about 215,000 of the 525,000-under-5 mortality worldwide each year that are attributed to diarrheal diseases, making it the most common cause of severe diarrhoea. ]]> <![CDATA[Roche Pharma India, SKCC, USA launch certification prog for oncologists, pathologists ]]> https://biospectrumindia.com/news/95/21844/roche-pharma-india-skcc-usa-launch-certification-prog-for-oncologists-pathologists-.html https://biospectrumindia.com/news/95/21844/roche-pharma-india-skcc-usa-launch-certification-prog-for-oncologists-pathologists-.html Tue, 23 Aug 2022 14:10:00 +0530 Roche Pharma India in partnership with Sidney Kimmel Cancer Center (SKCC) – Jefferson Health, Pennsylvania, USA and BioQuest Solutions, has launched a one-of-its-kind Advanced Certification Programme in Molecular Oncology (ACMO) to equip oncologists and pathologists in the country with methods of genomic/personalised medicine.    Around 100 healthcare professionals including 70 oncologists and 30 pathologists from across the country will be trained under this programme. Comprising 14 online modules, the programme spreads over eight months and aims to provide comprehensive, evidence-based updates on personalised medicine.   The programme faculty will include professors from various departments affiliated to Thomas Jefferson University, including oncology, urology, computational medicine, biochemistry and molecular biology. Interspersed with live virtual sessions, the online programme is a case-based, self-learning, interactive certification course.  ]]> <![CDATA[AstraZeneca bags DCGI approval for Lynparza to treat early breast cancer]]> https://biospectrumindia.com/news/95/21825/astrazeneca-bags-dcgi-approval-for-lynparza-to-treat-early-breast-cancer.html https://biospectrumindia.com/news/95/21825/astrazeneca-bags-dcgi-approval-for-lynparza-to-treat-early-breast-cancer.html Fri, 19 Aug 2022 18:25:00 +0530 AstraZeneca India has received Drugs Controller General of India (DCGI) approval to market its drug Lynparza (Olaparib) as a monotherapy for the adjuvant treatment of adult patients with BRCA-mutated HER2- negative high-risk early breast cancer, who have previously been treated with neoadjuvant or adjuvant chemotherapy.   The approval was based on results from the OlympiA Phase III trial, which suggested that Olaparib demonstrated a statistically significant and clinically meaningful improvement, with an overall survival benefit. With the DCGI’s approval, Lynparza is now approved in the US, EU, Japan, India and several other countries for the treatment of the same. Currently, Lynparza is the first and only approved medicine targeting BRCA mutations in early-stage breast cancer.   The results from the landmark OlympiA Phase III trial highlight the value and importance of testing for BRCA mutations at diagnosis. Olaparib demonstrated a statistically significant and clinically meaningful improvement in invasive disease-free survival (iDFS), reducing the risk of invasive breast cancer recurrences, second cancers or death by 42 per cent versus placebo. The newly updated results from the OlympiA trial also showed Lynparza demonstrated a statistically significant and clinically meaningful improvement in the key secondary endpoint of overall survival (OS), reducing the risk of death by 32% versus placebo. ]]> <![CDATA[Piramal Critical Care launches generic zinc sulfate injection in US]]> https://biospectrumindia.com/news/95/21820/piramal-critical-care-launches-generic-zinc-sulfate-injection-in-us.html https://biospectrumindia.com/news/95/21820/piramal-critical-care-launches-generic-zinc-sulfate-injection-in-us.html Fri, 19 Aug 2022 12:55:00 +0530 Piramal Pharma's Critical Care business, a leading Complex Hospital Generics company, announces the first-to-market generic US launch of Zinc Sulfate Injection. This product is US Food and Drug Administration approved with Competitive Generic Therapy (CGT) designation; an approval pathway intended to enhance market competition for sole source drugs. Zinc Sulfate is a trace element indicated as a source of zinc for parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. This intravenous nutritional injection is available in two strengths – 30mg/10mL (3mg/mL) and 25mg/5mL (5mg/mL).   ]]> <![CDATA[Mallcom India launches Freddie safety shoes for healthcare workers ]]> https://biospectrumindia.com/news/95/21814/mallcom-india-launches-freddie-safety-shoes-for-healthcare-workers-.html https://biospectrumindia.com/news/95/21814/mallcom-india-launches-freddie-safety-shoes-for-healthcare-workers-.html Thu, 18 Aug 2022 08:20:00 +0530 Kolkata-based Mallcom India, an integrated manufacturer of head-to-toe personal protection equipment, has entered a new segment with the introduction of aesthetically designed safety shoes- FREDDIE. Mallcom India’s FREDDIE shoe range is aimed to protect workers from all hazardous work environments. The shoe is primarily beneficial for workers who work long shifts in the healthcare sector.     Freddie by Mallcom India has strong-gripping soles, which are anti-slip, breathable, puncture and abrasion resistant making it a perfect choice for all healthcare workers. Even the workforce employed at pharmaceutical companies where maintenance of cleanliness and hygiene are of utmost importance can use these shoes.   Mallcom manufactures 3 million pairs of safety shoes each year across all its manufacturing units put together in Kolkata, Ahmedabad and Haridwar. It is also coming up with another unit in Ghatakpukur, Kolkata to ramp up the existing capacity of manufacturing safety shoes. Safety shoes account for one-third of the total revenue for Mallcom. ]]> <![CDATA[Ahd-based Concord Biotech files DRHP for IPO]]> https://biospectrumindia.com/news/95/21806/ahd-based-concord-biotech-files-drhp-for-ipo.html https://biospectrumindia.com/news/95/21806/ahd-based-concord-biotech-files-drhp-for-ipo.html Tue, 16 Aug 2022 16:00:00 +0530 Concord Biotech is the leading global developer and manufacturer of select fermentation-based APIs across immunosuppressants and oncology   Ahmedabad-based Concord Biotech, one of the leading global developers and manufacturers of select fermentation-based APIs across immunosuppressants and oncology in terms of market share, based on volume in 2021 has filed its Draft Red Herring Prospectus (DRHP) with the markets regulator, Securities and Exchange Board of India (SEBI), to raise funds through an initial public offering (IPO).   The issue with a face value of Re 1 per equity share is a complete offer for sale (OFS) aggregating to 20,925,652 equity shares by Helix Investment Holdings. The offer also includes a reservation for a subscription by eligible employees.   The offer is being made through the Book Building Process, wherein not more than 50 per cent of the offer shall be available for allocation to Qualified Institutional Buyers, not less than 15 per cent of the offer shall be available for allocation to non-institutional bidders and not less than 35 per cent of the offer shall be available for allocation to retail individual bidders.   Kotak Mahindra Capital Company, Citigroup Global Markets India, and Jefferies India are the book running lead managers and Link Intime India is the registrar to the offer. The equity shares are proposed to be listed on the BSE and the NSE. ]]> <![CDATA[Omics Data Automation unveils Bengaluru facility]]> https://biospectrumindia.com/news/95/21800/omics-data-automation-unveils-bengaluru-facility.html https://biospectrumindia.com/news/95/21800/omics-data-automation-unveils-bengaluru-facility.html Tue, 16 Aug 2022 10:20:00 +0530 Omics Data Automation (ODA), a leading provider of technology for healthcare data management and analysis, announced the opening of its newest office in Bengaluru, Karnataka in response to growing global demand for its software and services.   India is a priority market for ODA as well as a source of key commercial and development partnerships for the company. The new office will be the company's second formal location and will enable ODA to scale its market leading framework technology globally accelerating the launch of its solutions for federated learning and causal inference.     "The Bengaluru office is ODA's first service point outside the US and represents the strategic expansion of our brand in India and around the world.  Together with our employees working remotely across the globe as well as those in our Beaverton, OR office, the new facility will enable us to accelerate product development and deliver services throughout the region," said Noah Nasser, CEO, ODA. ]]> <![CDATA[Bharat Biotech completes clinical development for ph III trials of intranasal COVID-19 vaccine ]]> https://biospectrumindia.com/news/95/21798/bharat-biotech-completes-clinical-development-for-ph-iii-trials-of-intranasal-covid-19-vaccine-.html https://biospectrumindia.com/news/95/21798/bharat-biotech-completes-clinical-development-for-ph-iii-trials-of-intranasal-covid-19-vaccine-.html Mon, 15 Aug 2022 00:00:00 +0530 Bharat Biotech International Limited (BBIL) has announced that BBV154 (intra nasal vaccine) has proven to be safe, well-tolerated, and immunogenic in subjects in controlled clinical trials.     BBV154 is a recombinant replication-deficient adenovirus vectored vaccine with a pre-fusion stabilized spike protein. This vaccine candidate was evaluated earlier in phase I and II clinical trials with successful results. BBV154 has been specifically formulated to allow intranasal delivery. In addition, the nasal delivery system has been designed and developed to be cost-effective in low and middle-income countries.      It was developed in partnership with Washington University St Louis, which had designed and developed the recombinant adenoviral vectored constructs and evaluated them in preclinical studies for efficacy.   Suchitra K. Ella, Joint Managing Director, Bharat Biotech, said, “If approved, this intranasal vaccine will make it easier to deploy in mass immunization campaigns with an easy to administer formulation and delivery device. Vectored vaccines also enable faster development of targeted vaccines in response to emerging variants of concern. We hereby thank the volunteers, principle investigators, and clinical trial personnel for all their efforts.”       BBV154 is stable at 2-8°C for easy storage and distribution. Bharat Biotech has established large manufacturing capabilities at multiple sites across India, including Gujarat, Karnataka, Maharashtra and Telangana, with operations pan India.   ]]> <![CDATA[New deal strengthens digital health firm Congenica’s presence in India]]> https://biospectrumindia.com/news/95/21789/new-deal-strengthens-digital-health-firm-congenicas-presence-in-india.html https://biospectrumindia.com/news/95/21789/new-deal-strengthens-digital-health-firm-congenicas-presence-in-india.html Thu, 11 Aug 2022 12:10:00 +0530 UK-based Congenica, a digital health company that enables precision medicine through its world-leading diagnostic decision support platform for genomic data, has partnered with Bengaluru-based Avesthagen, a biotechnology major that specialises in predictive, preventive and personalised healthcare through the convergence of food, pharma and population genetics.   Congenica’s automated and AI-powered platform will provide genomic analysis and reporting for Avesthagen’s Avgen Diagnostics, which offers whole genome and exome-based diagnostics for predictive and preventive healthcare throughout India.   Congenica enables Avesthagen’s customers to rapidly interpret next-generation sequencing data with confidence, significantly accelerating the time to diagnosis, improving patient outcomes and reducing the burden on healthcare systems.   ]]> <![CDATA[BSV, Indian Institute of Science to work on next-gen snakebite therapy]]> https://biospectrumindia.com/news/95/21777/bsv-indian-institute-of-science-to-work-on-next-gen-snakebite-therapy.html https://biospectrumindia.com/news/95/21777/bsv-indian-institute-of-science-to-work-on-next-gen-snakebite-therapy.html Tue, 09 Aug 2022 12:30:00 +0530 Bharat Serums and Vaccines (BSV) has collaborated with ‘Evolutionary Venomics Lab’, at the Indian Institute of Science (IISc) Bangalore to develop region-specific antivenoms, thereby, pioneering next-generation snakebite therapy in India. Snakebite remains a serious public health challenge.  Currently, treatments are based on a single polyvalent antivenom designed for snakebites from the ‘big four’ snakes in the country. Recent research at the Evolutionary Venomics Lab has highlighted the alarming consequence of the inter and intra-species variation in venoms on the effectiveness of antivenom. The polyvalent antivenom inefficaciously neutralizes the venom from distinct populations of the ‘big four’ snakes, as well many other local clinically important snake species. Thus, there is an urgent need for the development of region-specific antivenom in the country. The partnership aims at driving the antivenom development that will deliver efficient snakebite therapy to save lives, limbs, and livelihoods of those in need of the treatment. Sanjiv Navangul, MD and CEO, BSV said, “We aim to partner with leading research institutes such as IISc to promote research in the neglected area of biodiscovery aspects of venom in India. Effective interventions involving education and antivenom provision would reduce snakebite deaths not only in India but also neighbouring countries in South Asia and Afghanistan.” ]]> <![CDATA[Cadila Pharma creates Collaboration Vertical to drive growth]]> https://biospectrumindia.com/news/95/21773/cadila-pharma-creates-collaboration-vertical-to-drive-growth.html https://biospectrumindia.com/news/95/21773/cadila-pharma-creates-collaboration-vertical-to-drive-growth.html Tue, 09 Aug 2022 08:55:00 +0530 Ahmedabad-based Cadila Pharmaceuticals has created a Collaboration Vertical to drive synergies in its next phase of growth. The Collaboration Vertical will work in close collaboration with different verticals of the company and usher in greater synergy and efficiency in the company’s operations.   “The Collaboration Vertical will play the role of binding together the different verticals and ensure optimum efficiencies and performances,” said Hitesh Sumariya, Collaboration Head at Cadila Pharmaceuticals.    The Collaboration Vertical will work closely with the leaders of different verticals as well as the top management in overall strategic planning and execution.  ]]> <![CDATA[Merck India's 3rd Annual Pharma Forum to be held in Hyd on August 10, 2022]]> https://biospectrumindia.com/news/95/21754/merck-indias-3rd-annual-pharma-forum-to-be-held-in-hyd-on-august-10-2022.html https://biospectrumindia.com/news/95/21754/merck-indias-3rd-annual-pharma-forum-to-be-held-in-hyd-on-august-10-2022.html Thu, 04 Aug 2022 10:50:00 +0530 The Process Solutions division of Merck India has announced its 3rd Annual Pharma Forum in Hyderabad on August 10, 2022. The focus of the event is 'Shaping the next-gen processing of pharma manufacturing.' The forum creates a platform for deep dive discussions with the industry experts on the future of BioPharma manufacturing, providing the latest insights on the process trends and quality approach in aseptic processing and discussing the regulations around it. Renowned industry experts like Dr Ranjit Barshikar, CEO QbD International, QbD / cGMP Consulting, United Nations Adviser, Geneva, Somasundaram G., Senior Consultant, Asia Pacific, Process Solutions,Merck KGaA, Ramesh Raju, Head of Operations, Validation Services lab, Merck KGaA amongst others.Experts will share their views from their respective areas of expertise, followed by a panel discussion on the most discussed topics in sterile pharmaceutical manufacturing. ]]> <![CDATA[RITES, Bill & Melinda Gates Foundation sign MoU on health goals]]> https://biospectrumindia.com/news/95/21752/rites-bill-melinda-gates-foundation-sign-mou-on-health-goals.html https://biospectrumindia.com/news/95/21752/rites-bill-melinda-gates-foundation-sign-mou-on-health-goals.html Thu, 04 Aug 2022 10:20:00 +0530 RITES, a public sector enterprise and leading transport infrastructure consultancy and engineering company, has signed a memorandum of understanding (MoU) with the Bill & Melinda Gates Foundation to advance goals on health, development, and gender equality in India, through their corporate social responsibility efforts. The MoU has been signed for two years.   The MoU will allow both organisations to collaborate and partner with the central and state governments and other not-for-profit and philanthropic organizations to develop strategic, high-impact, multi-year programmes with outcomes for the most vulnerable. In its first phase, the collaboration will jointly support projects focussed on women’s economic empowerment and accelerating the adoption of Ayushman Bharat Health Accounts (ABHA) using digital public goods platforms. ]]> <![CDATA[GOQii expands preventive healthcare portfolio ]]> https://biospectrumindia.com/news/95/21750/goqii-expands-preventive-healthcare-portfolio-.html https://biospectrumindia.com/news/95/21750/goqii-expands-preventive-healthcare-portfolio-.html Wed, 03 Aug 2022 00:00:00 +0530 Mumbai-based GOQii, the smart preventive healthcare company which has always been at the forefront of innovation, has expanded its preventive healthcare portfolio with stylish offerings.  The company has launched two new super stylish devices - Smart Vital Ultra & GOQii Stream targeting young adults and youth thereby encouraging them to lead a healthy and active lifestyle. These devices are truly revolutionary with personalised coaching by providing insights into your well-being that drives actionable care supported by data. The Smart Vital Ultra comes with a bigger screen, better resolution and all the data you need to go the extra mile. The GOQii Smart Vital Ultra has the latest in-built technology which lets you monitor your blood oxygen saturation levels (SpO2) as well as continuous and non-disruptive heart rate readings around the clock. It also helps you get a better understanding of your sleep patterns by getting an in-depth analysis of your SpO2 and heart rate while you’re asleep.  On the other hand, GOQii STream is a device that is feather light and water resistant and one from which you can make and receive calls. GOQii is also gearing up to its health metaverse. It will develop various offerings that leverage blockchain tokens and gamification in preventive healthcare. The metaverse ecosystem will be powered by a unique virtual token program, the Token. Consumers will receive the virtual token, which powers the GOQii metaverse ecosystem that incentivizes healthy behaviours and gamified fitness actions.   ]]> <![CDATA[Cadila Pharma launches generic sitagliptin versions to treat uncontrolled type 2 diabetes]]> https://biospectrumindia.com/news/95/21739/cadila-pharma-launches-generic-sitagliptin-versions-to-treat-uncontrolled-type-2-diabetes.html https://biospectrumindia.com/news/95/21739/cadila-pharma-launches-generic-sitagliptin-versions-to-treat-uncontrolled-type-2-diabetes.html Mon, 01 Aug 2022 12:10:00 +0530 Ahmedabad-based Cadila Pharmaceuticals has launched the generic versions of sitagliptin in India under the brand names Jankey and Sitenali to address type 2 diabetes.   Sitagliptin is a drug from the class of DPP-4 inhibitors, and a one-of-its-kind drug for the treatment of high glucose levels in the blood, also known as hyperglycaemia.   High blood glucose can lead to life-threatening complications such as atherosclerosis, stroke, heart attack, retinopathy, neuropathy and nephropathy.   The company has also launched a potent combination of Sitagliptin and Metformin and branded it as Jankey M.   Sitagliptin has a strong clinical profile and the potential to revolutionise the treatment of type 2 diabetes for millions of people who do not achieve the targeted blood sugar level with currently available anti-diabetic medications. ]]> <![CDATA[Medical cold chain solutions provider B Medical Systems opens unit in Delhi]]> https://biospectrumindia.com/news/95/21729/medical-cold-chain-solutions-provider-b-medical-systems-opens-unit-in-delhi.html https://biospectrumindia.com/news/95/21729/medical-cold-chain-solutions-provider-b-medical-systems-opens-unit-in-delhi.html Mon, 01 Aug 2022 00:00:00 +0530 Luxembourg-based medical cold chain solutions provider B Medical Systems has opened its new office based out of New Delhi, for its India subsidiary.This is B Medical Systems India’s third office in the country, following the ones opened in early 2021 in Mumbai and Ahmedabad. With increasing business opportunities in India, the company is focused on expanding its presence across the nation to support its clients and stakeholders in their efforts of creating safe, reliable and sustainable healthcare systems by providing high-quality medical cold chain solutions.During the event, an MoU was also signed between B Medical Systems India and the Selco Foundation for the two organisations to collaborate and strengthen India’s cold chain sector , with a focus on the mid and last-mile delivery of vaccines and critical samples to people living in remote areas of the country. ]]> <![CDATA[CARE Hospitals to acquire majority stake in United CIIGMA Hospitals, Aurangabad]]> https://biospectrumindia.com/news/95/21730/care-hospitals-to-acquire-majority-stake-in-united-ciigma-hospitals-aurangabad.html https://biospectrumindia.com/news/95/21730/care-hospitals-to-acquire-majority-stake-in-united-ciigma-hospitals-aurangabad.html Fri, 29 Jul 2022 17:30:00 +0530 Hyderabad-based CARE Hospitals Group announced the expansion in Maharashtra region through a strategic partnership with Aurangabad-based United CIIGMA Hospitals. Through this investment, CARE Hospitals will have a majority stake in United CIIGMA Hospitals and will be present across three cities in the state.    Dr Unmesh Takalkar, Chief MD, United CIIGMA Hospitals said, “With this partnership, our combined efforts with CARE Hospitals will allow us to scale up through better quality, newer and high-end specialities and make quality healthcare accessible to all our patients across Marathwada and beyond." ]]> <![CDATA[5th edition of REFCOLD India to be held in Gandhinagar from December 8 to 10, 2022]]> https://biospectrumindia.com/news/95/21726/5th-edition-of-refcold-india-to-be-held-in-gandhinagar-from-december-8-to-10-2022.html https://biospectrumindia.com/news/95/21726/5th-edition-of-refcold-india-to-be-held-in-gandhinagar-from-december-8-to-10-2022.html Fri, 29 Jul 2022 10:30:00 +0530 The 5th edition of REFCOLD India, South Asia’s largest exhibition and conference on refrigeration and cold chain industry solutions, will take place at Mahatma Mandir in Gandhinagar from December 8 to 10, 2022.   REFCOLD India is an initiative of The Indian Society of Heating, Refrigerating and Air Conditioning Engineers (ISHRAE), which has over 44 chapters and nearly 30,000 professional members. ISHRAE is also launching international chapters in Bangladesh, Nepal, Sri Lanka, Kenya and Abu Dhabi. ISHRAE has been actively working towards the growth of the refrigeration and cold chain industry to bring the best technology solutions and enhance the sector's growth.   REFCOLD India will bring together Indian and international refrigeration industry stakeholders, and usher in innovation in technology that works on eliminating food wastage. Cold Chain management has become an integral part of the supply chain industry comprising refrigerated storage and refrigerated transportation.    The event will also see technical workshops, panel discussions, and knowledge-sharing programmes. Buyer delegations from India and many other countries and various industry associations from across the globe are also expected to visit the exhibition.   ]]> <![CDATA[Hyd-based Zenara Pharma to manufacture, sell generic of Pfizer’s COVID-19 drug]]> https://biospectrumindia.com/news/95/21716/hyd-based-zenara-pharma-to-manufacture-sell-generic-of-pfizers-covid-19-drug.html https://biospectrumindia.com/news/95/21716/hyd-based-zenara-pharma-to-manufacture-sell-generic-of-pfizers-covid-19-drug.html Thu, 28 Jul 2022 12:35:00 +0530 Hyderabad-based Zenara Pharma, a fully owned subsidiary of Biophore India Pharmaceuticals, has announced that it has received approval from the Central Drugs Standard Control Organization (CDSCO) to manufacture and sell Nirmatrelvir and Ritonavir tablets in a combi pack as a treatment option for patients with mild to moderate symptoms of COVID-19. The tablet, which will be sold under the brand name ‘Paxzen’, is being manufactured at Zenara’s US FDA-approved state-of-the-art facility in Hyderabad. This approval by the CDSCO has been granted under the emergency authorisation route considering the unmet medical need in COVID-19 for an effective and affordable therapy for the patientsThis product’s breakthrough approval in the US was given by the US FDA in Dec 2021 and is indicated for the treatment of mild-to-moderate COVID-19 in adults. It was the first oral pill that has been approved by US FDA and with a better safety profile than subsequently approved oral therapies. ]]> <![CDATA[Pricing pressures, regulatory scrutiny persist in US generics pharma industry: ICRA]]> https://biospectrumindia.com/news/95/21704/pricing-pressures-regulatory-scrutiny-persist-in-us-generics-pharma-industry-icra.html https://biospectrumindia.com/news/95/21704/pricing-pressures-regulatory-scrutiny-persist-in-us-generics-pharma-industry-icra.html Wed, 27 Jul 2022 08:10:00 +0530 The US has always been a key market for Indian pharma companies, accounting for ~29 per cent of FY2022 revenues of ICRA’s sample set of eight leading pharma companies. However, over the past few years, the revenues from the US market have grown at a relatively modest pace, reflecting a confluence of challenges being faced by companies in the form of consistent pricing pressure, lack of major generic product launches and increased regulatory scrutiny.    In FY2022, the revenues from the US pharma market for our sample of leading pharma companies declined marginally by 0.2 per cent owing to high single-digit to low teens price erosion. Accordingly, the share of revenues from the US for ICRA’s sample set has declined from ~40 per cent earlier over the last few years on account of muted revenue growth in the overall US generics market in FY2021 and FY2022, coupled with an increased focus on other regulated and semi-regulated markets. Nonetheless, the US remains one of the most important markets for Indian pharmaceutical companies, both from a growth and earnings perspective. Companies will continue to focus on new product launches and complex generics, including first-to-file opportunities to improve margins for the US business.    Companies with a limited basket of products and deriving a majority of their revenues from the oral solids segment are relatively more vulnerable to heightened competitive intensity in the segment. With a relatively lower number of approvals for new products, the players who had earlier reduced their focus on some molecules re-entered these products, impacting the realisations, and in turn leading to higher pricing pressures in the oral solids segment. Moreover, citing continued pricing pressures and intense competition in the US generics business, in recent quarters, some major Indian pharmaceutical companies reported sizeable impairment losses and also announced the discontinuation of some products or segments due to lower earnings potential.    The pace of ANDA approvals as well as the issuance of warning letters to Indian pharma companies have been lower over the past two years, given USFDA’s inability to conduct physical inspections in the light of the pandemic-induced restrictions. However, the same is likely to pick up over the medium term as inspections gain traction. ]]> <![CDATA[Sun Pharma announces territory expansion of acne medication supply]]> https://biospectrumindia.com/news/95/21701/sun-pharma-announces-territory-expansion-of-acne-medication-supply.html https://biospectrumindia.com/news/95/21701/sun-pharma-announces-territory-expansion-of-acne-medication-supply.html Tue, 26 Jul 2022 16:10:00 +0530 Sun Pharmaceutical Industries and Cassiopea, a subsidiary of Ireland-based Cosmo Pharmaceuticals, have announced the signing of addendums to the License and Supply Agreements for WINLEVI (clascoterone) cream 1 per cent expanding the territory to include Japan, Australia, New Zealand, Brazil, Mexico and Russia.    Under the terms of the agreements, Sun Pharma will receive from Cassiopea the exclusive right to develop and commercialize WINLEVI in Japan, Australia, New Zealand, Brazil, Mexico and Russia. Cosmo will be the exclusive supplier of the product. Cassiopea will receive an upfront payment of $ 7 million, potential regulatory and sales milestones and customary double-digit royalties on net sales.    A first-in-class topical androgen receptor inhibitor, WINLEVI was approved by the U.S. Food and Drug Administration (FDA) in August 2020 for the topical treatment of acne vulgaris in patients 12 years of age and older. WINLEVI is the first FDA-approved acne drug with a first-in-class mechanism of action in nearly 40 years.   ]]> <![CDATA[Hyderabad-based Medmokk Enterprises to diversify healthcare portfolio]]> https://biospectrumindia.com/news/95/21688/hyderabad-based-medmokk-enterprises-to-diversify-healthcare-portfolio.html https://biospectrumindia.com/news/95/21688/hyderabad-based-medmokk-enterprises-to-diversify-healthcare-portfolio.html Mon, 25 Jul 2022 11:15:00 +0530 UK-based, global conglomerate, SRAM & MRAM Group have announced their collaboration with Hyderabad-based healthcare R&D company Medmokk Enterprises. With the pact in place, the joint venture will work extensively in the healthcare domain. The group will be investing in the R&D and expansion of the current portfolio. Medmokk is a leading R&D company involved in the healthcare industry with a specific focus on general medicine, dental medicine and allied activities. They are the producers of Aquaox solution and Dhvani, a low-cost hearing device. Recently, Medmokk introduced India’s first, patented “Oral health Remote Screening Device”. The collaboration between SRAM & MRAM Group and Medmokk Enterprises aims to reach out to a larger audience with cutting-edge technology. "The collaboration will help us to ascertain the market leadership in the Healthcare vertical. With the patented technology and advanced R&D in Oral health, it will certainly help us to produce innovative tech healthcare products," quoted NVR Suresh, Executive Director, SRAM & MRAM Group. ]]> <![CDATA[Merck invests €200,000 in microbiology application lab in Bengaluru]]> https://biospectrumindia.com/news/95/21672/merck-invests-200000-in-microbiology-application-lab-in-bengaluru.html https://biospectrumindia.com/news/95/21672/merck-invests-200000-in-microbiology-application-lab-in-bengaluru.html Thu, 21 Jul 2022 14:40:00 +0530 Merck has announced the opening of its first Microbiology Application and Training (MAT) Lab in Jigani, Bengaluru, offering facilities and technical expertise to support the Indian life science community on microbial quality control capability development.   With an investment of €200,000, the MAT Centre spans an area size of 1,100 sqft. The testing services offered in the Lab include sterility testing, rapid bioburden testing, pyrogen testing, advance membrane filtration and other pharma QC microbiology applications.   The MAT Lab includes a vibrant space for certified training, application support, feasibility studies and method development for Pharma and Biopharma industries.   The Lab offers customizable solutions and services that help pharmaceutical and biopharma companies as well as regulatory to improve their processes from drug discovery, development to manufacturing.   ]]> <![CDATA[Less than one in four Indians aware of brain stroke symptoms: BI survey]]> https://biospectrumindia.com/news/95/21669/less-than-one-in-four-indians-aware-of-brain-stroke-symptoms-bi-survey.html https://biospectrumindia.com/news/95/21669/less-than-one-in-four-indians-aware-of-brain-stroke-symptoms-bi-survey.html Thu, 21 Jul 2022 11:00:00 +0530 Boehringer Ingelheim India has released the findings of India’s first consumer survey on brain stroke titled - The State of Stroke: A Survey On Awareness About Stroke In Urban India, ahead of World Brain Day, 2022. The survey was commissioned by Boehringer Ingelheim India and conducted by IPSOS, a global leader in market research.    Boehringer Ingelheim India commissioned a national survey that brought to the fore, the ‘lack of awareness around brain stroke’ in the country. The survey, conducted by IPSOS with a sample size of 4742, across 12 cities in India revealed that only 22 per cent of the respondents were aware of the risk factors and symptoms of brain stroke, and the awareness levels further drop to just 10 per cent with respect to the treatment options.   The findings of this survey pointed to lower awareness levels of disease condition, particularly in smaller towns and lower socio-economic class:   ·      71 per cent of the respondents from metros were aware of the disease in comparison to only 48 per cent in mini metros ·      Compared to the National average of 70 per cent ~ only 1/3rd of the respondents in the city of Pune, Chandigarh and Lucknow recalled awareness of the term brain stroke with respondents from the East being the most aware ·      Brain stroke literacy on FAST (Facial drooping, Arm weakness, Speech difficulties and Time) symptoms was uniformly low across geographies ·      Only 2 per cent of respondents from mini metros knew all three symptoms of brain stroke compared to 12 per cent of respondents from Metros   Boehringer Ingelheim India launched a website - strokeofsupport.com. The dedicated website is an online stroke support and information portal designed to help both patients and caregivers.    ]]> <![CDATA[Covaxin demonstrates persistant immunity against emerging variants after booster dose]]> https://biospectrumindia.com/news/95/21667/covaxin-demonstrates-persistant-immunity-against-emerging-variants-after-booster-dose.html https://biospectrumindia.com/news/95/21667/covaxin-demonstrates-persistant-immunity-against-emerging-variants-after-booster-dose.html Wed, 20 Jul 2022 18:10:00 +0530 Bharat Biotech International has announced that BBV152 (COVAXIN), its whole-virion inactivated COVID-19 vaccine, has proven to be safe, well-tolerated, and immunogenic in subjects in controlled clinical trials. The study has been accepted and published in Nature Scientific Reports.   The comprehensive study has demonstrated multiple benefits of COVAXIN, such as long-term immune response, cell-mediated immunity, the safety of booster dose, immunogenicity against spike  protein, N protein and neutralising antibody responses against alpha, beta, delta, delta plus and omicron variants.     The study was conducted on ~184 subjects, who were randomised 1:1 and received either a booster dose of BBV152 or a placebo, ~six months after the primary series of twp doses. Subjects were evaluated for safety, neutralising antibody responses against variants of concern, binding antibodies against spike protein, RBD, N proteins, and for memory T and B cell responses to demonstrate cell-mediated immunity.   Dr Krishna Ella, CMD, Bharat Biotech, said, “We have now achieved our goal of developing a safe and efficacious vaccine with long-term protection against a spectrum of variants.”   Bharat Biotech has a stockpile of more than 50 million doses of COVAXIN ready to be distributed as required.    ]]> <![CDATA[SPAG Founder Aman Gupta joins FINN Health Practice as managing partner]]> https://biospectrumindia.com/news/95/21662/spag-founder-aman-gupta-joins-finn-health-practice-as-managing-partner.html https://biospectrumindia.com/news/95/21662/spag-founder-aman-gupta-joins-finn-health-practice-as-managing-partner.html Tue, 19 Jul 2022 18:05:00 +0530 ]]> <![CDATA[Entod Pharma forays into medical, cosmetic skincare market]]> https://biospectrumindia.com/news/95/21657/entod-pharma-forays-into-medical-cosmetic-skincare-market.html https://biospectrumindia.com/news/95/21657/entod-pharma-forays-into-medical-cosmetic-skincare-market.html Tue, 19 Jul 2022 13:10:00 +0530 ENTOD Pharmaceuticals has recently launched its dermatological venture in India in collaboration with its UK sister concern ENTOD Beauty London Ltd.   ENTOD Beauty London products will now be sold in India through Entod Pharmaceuticals nationwide sales field representative and distributor networks. The UK-developed products will be manufactured in India under the Make in India Initiative and through a technology transfer arrangement between the two companies.   "The products intended for India have been specially designed for Indian skin types after detailed consultations with Indian dermatologists and skincare experts. A successful Indian venture will also allow us to build a better global brand presence and keep innovating in the medical & cosmetic dermatology segments” said Dana Grossman, GM, ENTOD Beauty London.   Two of Entod Beauty London’s skincare products that have created a roar in global markets in recent times are Lashfactor and Vasuki. Lashfactor is the world's first clinically tested nanotechnology-based eyelash and eyebrow prostaglandin growth serum that is developed to enhance & give more prominent eyelashes & eyebrows. Vasuki on the other hand is a synthetic tripeptide snake venom serum complex that gently relaxes muscle contractions under the skin, and has shown in clinical studies to reduce both dynamic and static lines & wrinkles in early ageing skin.     ]]> <![CDATA[Research-to-launch cryopreservation bank opens in Chennai]]> https://biospectrumindia.com/news/95/21644/research-to-launch-cryopreservation-bank-opens-in-chennai.html https://biospectrumindia.com/news/95/21644/research-to-launch-cryopreservation-bank-opens-in-chennai.html Fri, 15 Jul 2022 19:35:00 +0530 Bridging the growing supply-chain gap in preservation and maintenance of biospecimens by leveraging advanced technologies, Cellutions BioStorage, a research-to-launch Cryopreservation Bank was inaugurated in Chennai. Brainchild of India’s leading health-preneur, Mayur Abhaya - Cellutions BioStorage is a comprehensive biomaterial storage and logistics company that aims to serve biopharmaceutical companies seeking to outsource the whole gamut of supply-chain management, across the spectrum of the product life cycle. The company through a range of services will provide transparency into the entire chain of custody and condition of the biospecimens. The newly-launched facility is equipped with world-class infrastructure spread across over 25,000 square feet. It is co-located in a separately marked area at the same licensed premises as LifeCell’s current laboratory at Chennai. As part of this launch, Cellution Biostorage also announced its maiden collaboration with LifeCell International, India’s leading stem cell bank, as its first client. ]]> <![CDATA[Pfizer India partners with Max Super Speciality Hospitals]]> https://biospectrumindia.com/news/95/21640/pfizer-india-partners-with-max-super-speciality-hospitals.html https://biospectrumindia.com/news/95/21640/pfizer-india-partners-with-max-super-speciality-hospitals.html Fri, 15 Jul 2022 13:00:00 +0530 Pfizer India has signed a Memorandum of Understanding (MoU) with Max Super Specialty Hospitals to give fellowships to young doctors in 17 Max Hospitals to gather real-world evidence on drug efficacy and proven therapies from existing electronic patient records. This evidence generation will focus on the prevention, treatment and management of diseases that are of public health priority in India, such as cancer and cardiovascular disease. The bespoke fellowships will be a form of recognition and will enable young clinicians who want to pursue medical research to do so with clear goals in place.    The fellowship programme will provide young clinicians and researchers at all 17Max Speciality Hospitals across 4 states in India, with an opportunity to acquire funding and sponsorships for their research work. The selection criteria for these fellowships will be decided by the medical and research experts at Max Healthcare. Pfizer will provide technical and financial support to the programme.   Additionally, through this collaboration, Pfizer and Max Hospitals plan to build centres of excellence in rare diseases. The MAX hospital will be COE for placing various RWE studies, capability-building workshops and fellowship programmes in rare disease areas to start with.  ]]> <![CDATA[Cipla Health to acquire Endura Mass]]> https://biospectrumindia.com/news/95/21637/cipla-health-to-acquire-endura-mass.html https://biospectrumindia.com/news/95/21637/cipla-health-to-acquire-endura-mass.html Fri, 15 Jul 2022 10:25:00 +0530 Cipla Health Limited (CHL), a wholly-owned subsidiary and consumer healthcare arm of the company has signed definitive agreements for the acquisition of Endura Mass from Medinnbelle Herbalcare. Endura and all other associated trademarks would be part of the acquisition.     The acquisition is in line with Cipla’s strategic imperative to augment the company’s wellness portfolio for bringing about a shift from an illness to a wellness mindset.   As per the signed definitive agreements, the acquisition is subject to the completion of certain closing conditions. CHL shall immediately initiate the distribution and marketing of the said products pending the closure of the proposed acquisition. ]]> <![CDATA[Syngene signs 10-year biologics manufacturing agreement with Zoetis]]> https://biospectrumindia.com/news/95/21636/syngene-signs-10-year-biologics-manufacturing-agreement-with-zoetis.html https://biospectrumindia.com/news/95/21636/syngene-signs-10-year-biologics-manufacturing-agreement-with-zoetis.html Fri, 15 Jul 2022 09:40:00 +0530 Syngene International has announced the signing of a 10-year agreement with a leading animal health company, Zoetis, to manufacture the drug substance for Librela (bedinvetmab), a first-in-class monoclonal antibody used for treating osteoarthritis in dogs.    Syngene’s collaboration with Zoetis started in 2011. Over the past 11 years, Syngene has undertaken development work on several monoclonal antibodies for use in animal health, including developing and manufacturing clinical supplies of treatment for allergic or atopic dermatitis, now widely used, and Librela.    This agreement, initially centred on Librela, paves the way for the development and manufacturing of other molecules in the coming years and is expected to be worth up to $500 million to Syngene over 10 years, subject to regulatory approvals and market demand. ]]> <![CDATA[ICRA’s sample set of Indian pharma cos to grow by 6-7 per cent in FY2023]]> https://biospectrumindia.com/news/95/21635/icras-sample-set-of-indian-pharma-cos-to-grow-by-6-7-per-cent-in-fy2023.html https://biospectrumindia.com/news/95/21635/icras-sample-set-of-indian-pharma-cos-to-grow-by-6-7-per-cent-in-fy2023.html Thu, 14 Jul 2022 19:55:00 +0530 The revenue growth of ICRA’s sample set of 16 Indian pharmaceutical companies is estimated to moderate to 6-7 per cent in FY2023 after witnessing a Y-o-Y growth in revenues of 8.5 per cent in Q4 FY2022 and 7.7 per cent in FY2022 to Rs 1.87 lakh crore. The sample set revenue growth will be supported by 6-8 per cent YoY growth in the domestic market, 11-13 per cent in the emerging markets and 8-10 per cent in the European business. Growth in the US business, however, is expected to be muted at 1-3 per cent, owing to continued pricing pressures in the generics business.   ICRA expects the operating profit margin (OPM) of the sample set to moderate to 20.2 per cent in FY2023 from 21.5 per cent in FY2022 given the continued pricing pressures in the US generics market and high raw material and other input costs. The extent of the impact on margins will differ from company to company depending on the product portfolio, the geographic mix of revenues and the diversification of the vendor base.    The OPM for the sample set contracted to 18.3 per cent in Q4 FY2022 from 22.3 per cent in Q4 FY2021 and 21 per cent in Q3 FY2022. This was majorly on account of rising costs of raw materials, other input costs such as freight, packaging among others, pricing pressures in the US generics market (which is generally the most profitable market), and inventory write-offs for COVID-19 products for a few companies in the sample.    During Q4 FY2022, the Y-o-Y revenue growth for the sample set in the domestic market was healthy at 13.5 per cent, supported by new product launches, market share gains for some companies in the sample set, and robust performance of both chronic/acute segments.    The emerging markets witnessed a healthy Y-o-Y growth of 14.3 per cent in revenues in Q4 FY2022, although revenues were marginally lower by 2 per cent on a Q-o-Q basis. Overall growth for FY2022 was healthy at 17 per cent on a Y-o-Y basis and was broad-based, spread across all key regions. This was driven by new product launches, low base, strong demand and depreciation of the INR against certain currencies.   ICRA expects the research and development (R&D) expenses to stabilise at current levels of 7-7.5 per cent of revenues for its sample set as companies continue to focus on complex generics, first-to-file opportunities and speciality products, which entail higher R&D expenses. Stable investments in R&D to develop such products will support growth and margin improvement over the medium term.   The outlook for the Indian pharma industry remains stable led by the expectation of continued healthy revenue growth and margins.    ]]> <![CDATA[Infosys acquires BASE life science to strengthen footprint across Europe]]> https://biospectrumindia.com/news/95/21624/infosys-acquires-base-life-science-to-strengthen-footprint-across-europe.html https://biospectrumindia.com/news/95/21624/infosys-acquires-base-life-science-to-strengthen-footprint-across-europe.html Thu, 14 Jul 2022 10:30:00 +0530 IT firm Infosys has announced a definitive agreement to acquire Denmark-based BASE life science, leading technology and consulting firm in the life sciences industry, in Europe.   The acquisition reaffirms the commitment to helping global life sciences companies realise business value from cloud-first digital platforms and data to speed-up clinical trials and scale drug development, positively impacting lives and achieving better health outcomes.   BASE brings to Infosys, domain experts with commercial, medical, digital marketing, clinical, regulatory, and quality know-how. Backed by a team of data science specialists, BASE is at the frontier of the latest technological developments and trends. It has a strong focus on data and AI, and the ability to bridge and integrate business logic and technology, driving insights for better health outcomes.   Together with Infosys, BASE will further expand its portfolio of expertise into consumer health, animal health, medtech and genomics segments. BASE collaborates with leading software technology providers in the life sciences industry such as Veeva, IQVIA and Salesforce. The acquisition is expected to close during the second quarter of fiscal 2023, subject to customary closing conditions. ]]> <![CDATA[Ayu Health forays into Delhi-NCR market]]> https://biospectrumindia.com/news/95/21621/ayu-health-forays-into-delhi-ncr-market.html https://biospectrumindia.com/news/95/21621/ayu-health-forays-into-delhi-ncr-market.html Wed, 13 Jul 2022 17:25:00 +0530 Ayu Health Hospitals announced its entry into the Delhi-NCR market by adding 25 hospitals to its network. Through this expansion, Ayu Health will have more than 1500 hospital beds in this region. The expansion is aided by Series B funding of $27 million raised from The Fundamentum Partnership and others, last month. With this expansion, Ayu Health will be present across the cities of Bengaluru, Jaipur, Chandigarh and Delhi-NCR.   Felix Hospital, PSRI, Kalra Hospital, Manas Hospital, Vimhans Hospital etc. are some of the top hospitals they have partnered with in Delhi-NCR.    Himesh Joshi, Co-Founder & CEO, Ayu Health said, ““Now we have hospitals in Noida, Delhi, Faridabad and Ghaziabad and we are focusing on the entire region. Given our presence in Chandigarh and Jaipur, the intent is to have a presence across the entire region as a continuum. As a part of that, we would be adding another 25-30 hospitals to our network in the city, over the next three months. Our target is to become the largest hospital chain in the country by end of this year." ]]> <![CDATA[Piramal Pharma Solutions opens API plant at Aurora, Canada]]> https://biospectrumindia.com/news/95/21615/piramal-pharma-solutions-opens-api-plant-at-aurora-canada.html https://biospectrumindia.com/news/95/21615/piramal-pharma-solutions-opens-api-plant-at-aurora-canada.html Wed, 13 Jul 2022 11:50:00 +0530 Piramal Pharma Solutions officially inaugurated a new active pharmaceutical ingredient (API) plant at the company's site in Aurora, Ontario.   The new plant, built as part of a CAD $30 million capital investment in the Aurora site, features more than 10000 square feet of new manufacturing space and includes two new reactor suites with additional filtration and drying capabilities. It will support ongoing customer demand for Piramal Pharma Solutions' expertise in APIs and enhances and expands the company's ability to produce clinical to commercial scale APIs, including highly potent APIs requiring an Occupational Exposure Limit (OEL) of 1mcg/m3.             ]]> <![CDATA[Godrej InsuliCool to aid in insulin storage for diabetics]]> https://biospectrumindia.com/news/95/21607/godrej-insulicool-to-aid-in-insulin-storage-for-diabetics.html https://biospectrumindia.com/news/95/21607/godrej-insulicool-to-aid-in-insulin-storage-for-diabetics.html Tue, 12 Jul 2022 14:15:00 +0530 Godrej Appliances has launched the InsuliCool product range - Godrej InsuliCool and Godrej InsuliCool+, innovative cooling solutions designed for insulin storage, to address the challenge faced by diabetic patients with insulin storage at recommended temperatures.    Using cutting-edge technology and innovation, Godrej InsuliCool product range is equipped with advanced solid-state thermoelectric cooling technology and is designed to work even at ambient temperatures up to 43°C, maintaining the system’s internal temperature of 2°- 8°C always. The display indicator on the front of the unit shows that the insulin is being stored at the correct temperature. With a storage capacity of 560ml, it can easily store nine vials; alternatively, two pens and five cartridges can be stored by removing the vials holder.    The product also has wider applications requiring storage of vital temperature-sensitive vaccines, medicines, vials for drops, other medical samples and specimens at a precise temperature between 2°- 8°C to retain its potency. ]]> <![CDATA[Glenmark unveils MINYM GEL to treat severe acne ]]> https://biospectrumindia.com/news/95/21597/glenmark-unveils-minym-gel-to-treat-severe-acne-.html https://biospectrumindia.com/news/95/21597/glenmark-unveils-minym-gel-to-treat-severe-acne-.html Mon, 11 Jul 2022 10:10:00 +0530 Mumbai-based Glenmark Pharmaceuticals has launched India’s first topical Minocycline 4 per cent gel for the treatment of moderate to severe acne, under the brand name MINYM. This is a potent anti-bacterial gel which exerts a strong anti-inflammatory action It also offers the lowest MIC90 (minimum Inhibitory Concentration at which it stops/prevents visible growth of 90 per cent of isolates of bacteria) compared to the available topical antibacterial formulations.MINYM Gel (Topical Minocycline 4 per cent gel) has been developed to address these growing concerns in the treatment of acne and is safe to use in patients above nine years of age. In a study conducted by Glenmark in 2020, on the prevalence of acne in India, it was observed that 45 percent of the patients were males and 55 percent were females; and almost 72 percent of the patients were in the adolescent group whereas 27 percent patients were in the adult group. ]]> <![CDATA[Surya Brasil launches global campaign to create awareness around hair allergy]]> https://biospectrumindia.com/news/95/21594/surya-brasil-launches-global-campaign-to-create-awareness-around-hair-allergy.html https://biospectrumindia.com/news/95/21594/surya-brasil-launches-global-campaign-to-create-awareness-around-hair-allergy.html Fri, 08 Jul 2022 19:35:00 +0530 Multinational vegan personal care brand Brazil-headquartered Surya Brasil has announced a week-long global campaign aimed at creating awareness around the issue. The campaign, titled ‘Hair Allergy Awareness Week by Surya Brasil’, was kickstarted across more than 40 countries, including India, Brazil, the US, the UK and Japan, among others, and is slated to conclude on July 14. Surya Brasil would on each day of the campaign share important information about the treatment and prevention of hair-related allergies with millions of its users across the globe.   The complete product range of the vegan personal care brand combines the power of Ayurveda and technology along with the rich natural resources of Brazil.     ]]> <![CDATA[vHealth by Aetna forays into western India]]> https://biospectrumindia.com/news/95/21588/vhealth-by-aetna-forays-into-western-india.html https://biospectrumindia.com/news/95/21588/vhealth-by-aetna-forays-into-western-india.html Thu, 07 Jul 2022 20:50:00 +0530 vHealth by Aetna is strengthening its presence in the western part of India. The company is comprehensively providing its services in four Western states - Maharashtra, Goa, Gujarat and Rajasthan. The company is looking beyond the metro cities and bringing high-quality healthcare services to tier II and tier III cities by aggressively expanding its existing provider network, subscriber base and channel partners.vHealth is building a robust network of top healthcare providers in West India, including trusted diagnostics partners like Tata 1mg, Thyrocare etc.; leading offline pharmacy chains such as Easy medico and other online pharmacies for doorstep medicine delivery; top hospitals for OPD services like PD Hinduja, Currae Hospital, Reliance Hospital, MGM New Bombay Hospital etc. and dental chains like Clove Dental, to name a few. ]]> <![CDATA[Micro Labs, manufacturer of Dolo-650, under IT lens]]> https://biospectrumindia.com/news/95/21587/micro-labs-manufacturer-of-dolo-650-under-it-lens.html https://biospectrumindia.com/news/95/21587/micro-labs-manufacturer-of-dolo-650-under-it-lens.html Thu, 07 Jul 2022 16:20:00 +0530 The Income Tax (IT) department came knocking at the doors of Bengaluru-based Micro Labs for alleged tax evasions. It may be noted that Micro Labs is the manufacturer of the Dolo-650 tablet, used by COVID-19 patients and became quite popular.The IT dept is checking the financial documents, balance sheets and business distributor networks of the company as part of the searches. More than 20 IT officials are conducting search operations.According to the sources in the IT department, simultaneous raids were conducted in 40 locations by 200 officers across the country, including New Delhi, Sikkim, Punjab, Tamil Nadu and Goa. There is news that the residences of Micro Labs CMD Dileep Surana, Director, Anand Surana have been raided.There are reports that the company has sold 350 crore tablets and earned revenues worth Rs 400 crores since the outbreak of COVID-19 outbreak in 2020.   Sanjiv Das sanjiv.das@mmactiv.com ]]> <![CDATA[GE Healthcare opens 5G Innovation Lab in Bengaluru]]> https://biospectrumindia.com/news/95/21586/ge-healthcare-opens-5g-innovation-lab-in-bengaluru.html https://biospectrumindia.com/news/95/21586/ge-healthcare-opens-5g-innovation-lab-in-bengaluru.html Thu, 07 Jul 2022 15:45:00 +0530 GE Healthcare has launched its 5G Innovation Lab in India, the first for GE Healthcare across the globe. Situated at the John F. Welch Technology Centre (JFWTC) Bengaluru, GE Healthcare’s largest R&D centre outside of the US, the lab will serve as a testbed to develop future-ready products and solutions, turning a new corner in innovation. It houses state-of-the-art infrastructure, including a private 5G network for testing and development. It provides expertise as well as a platform for a collaborative ecosystem for academia, the healthcare industry, and startups, facilitating exploration and enabling validation and qualification of 5G-enabled Precision Healthcare use cases.The GE Healthcare 5G Innovation Lab will serve as a conduit for the interplay of exponential technologies like AI/ML, IoT, Big Data, Edge Computing and Cybersecurity. ]]> <![CDATA[ Glenmark launches Sitagliptin for adults with Type 2 diabetes in India]]> https://biospectrumindia.com/news/95/21584/-glenmark-launches-sitagliptin-for-adults-with-type-2-diabetes-in-india.html https://biospectrumindia.com/news/95/21584/-glenmark-launches-sitagliptin-for-adults-with-type-2-diabetes-in-india.html Thu, 07 Jul 2022 12:35:00 +0530 Glenmark Pharmaceuticals has launched sitagliptin and its Fixed Dose Combinations (FDCs), at an affordable price for adults with Type 2 diabetes in India. The company has introduced eight different combinations of sitagliptin-based drugs under the brand name SITAZIT and its variants at an affordable price.The medicines will be available under the brand name SITAZIT, SITAZIT- M, SITAZIT- M ER and SITAZIT D.Each of these brands will have two different variants – SITAZIT (sitagliptin) will be available in 50 mg and 100 mg variants; SITAZIT M will have sitagliptin (50 mg) + metformin (500 mg/ 1000 mg); SITAZIT M ER will have sitagliptin (100 mg) + metformin SR (500 mg/ 1000 mg). The brand SITAZIT D is a new combination with two variants SITAZIT D 100/10, which will have sitagliptin (100 mg) + dapagliflozin (10 mg) and SITAZIT D 50/5 which will have sitagliptin (50 mg) + dapagliflozin (5 mg). ]]> <![CDATA[OMRON Healthcare introduces medical molecular sieve oxygen concentrator]]> https://biospectrumindia.com/news/95/21569/omron-healthcare-introduces-medical-molecular-sieve-oxygen-concentrator.html https://biospectrumindia.com/news/95/21569/omron-healthcare-introduces-medical-molecular-sieve-oxygen-concentrator.html Wed, 06 Jul 2022 00:00:00 +0530 OMRON Healthcare has announced its latest advancement in the oxygen therapy category with the launch of a portable oxygen concentrator. It is a medical molecular sieve-based oxygen concentrator providing a continuous supply of high purity oxygen (5L per minute) with more than 90 per cent high concentration output. The product is designed to aid the homecare providers when managing the therapy and lifestyle needs of nearly all patients with COPD and respiratory problems.    The OMRON Oxygen Concentrator uses high-quality medical molecular sieves to ensure the efficiency and the quality of the oxygen while keeping the portability quotient of the device in check which makes it easier to carry around.    The device also has a high-impact resistant design with large fan blades for a quick cool down. It works on PSA (Pressure Swing Adsorption) technology that helps in separating nitrogen, oxygen and other elements. A 360-degree mute wear-resistant universal caster wheel makes it easier to move around.   The product will initially be available in the metro cities in OMRON’s authorised experience centres, and it will be made available through e-commerce channels soon. ]]> <![CDATA[Lenovo & CSIR-IGIB accelerate cancer research through genetic analysis]]> https://biospectrumindia.com/news/95/21576/lenovo-csir-igib-accelerate-cancer-research-through-genetic-analysis.html https://biospectrumindia.com/news/95/21576/lenovo-csir-igib-accelerate-cancer-research-through-genetic-analysis.html Wed, 06 Jul 2022 00:00:00 +0530 Lenovo, the global technology leader, is collaborating with the CSIR Institute of Genomics and Integrative Biology (CSIR-IGIB), New Delhi, in a unique partnership to advance cancer research by digging deeper into the genetic roots of disease. This partnership uses Lenovo’s high-performance Genomics Optimization and Scalability Tool (GOAST) architecture, featuring 2nd Gen Intel Xeon Scalable processors, to power through ultra-intensive genomic sequencing workloads and help researchers find insights faster. Lenovo’s GOAST is a high-performance computing (HPC) architecture engineered specifically for demanding genomics workloads that is a significant contributor to this initiative. Working closely with Lenovo’s high-performance computing services, CSIR-IGIB deployed a 28-node system—the largest GOAST installation in India to date. By leveraging an optimized architecture and efficient open-source software, GOAST offers GPU-level performance at CPU-level costs, making it an attractive proposition for a public sector body such as CSIR-IGIB. CSIR-IGIB has seen a significant performance impact from the Lenovo GOAST system for both whole genome sequencing (WGS) and whole exome sequencing (WES) workflows. “It is through institutions like IGIB that decisive advances in healthcare are being achieved – from treatments and vaccines for acute diseases, to strategies for managing and overcoming chronic conditions. We are glad to partner and provide crucial technical support to IGIB’s new Center of Excellence. It is likely to become the largest site for GOAST in Asia Pacific,” said Sinisa Nikolic, Director, HPC-AI, Infrastructure Solutions Group, Lenovo Asia Pacific.   ]]> <![CDATA[Biocon Biologics bags EU GMP certificate for its facility at Biocon Park, Bengaluru]]> https://biospectrumindia.com/news/95/21573/biocon-biologics-bags-eu-gmp-certificate-for-its-facility-at-biocon-park-bengaluru.html https://biospectrumindia.com/news/95/21573/biocon-biologics-bags-eu-gmp-certificate-for-its-facility-at-biocon-park-bengaluru.html Tue, 05 Jul 2022 19:25:00 +0530 Biocon Biologics, a subsidiary of Biocon, has received an EU GMP certificate from the Health Products Regulatory Authority (HPRA), Ireland, for its new monoclonal antibodies (mAbs) drug substance manufacturing facility (B3) at Biocon Park, Bengaluru, following a GMP inspection in April 2022. The facility, spread across 340,000 square feet, will enhance the capabilities manifold to manufacture drug substances of the mAbs portfolio and will enable to serve patients across the globe. This integrated, multi-product facility houses manufacturing suites, analytical testing laboratories and warehousing. Upon successful completion and qualification in 2021, it was awarded the Facility of the Year Award (FOYA) with an Honorable Mention, by the International Society for Pharmaceutical Engineering (ISPE).  ]]> <![CDATA[MedleyMed launches Ananda E-Clinic]]> https://biospectrumindia.com/news/95/21570/medleymed-launches-ananda-e-clinic.html https://biospectrumindia.com/news/95/21570/medleymed-launches-ananda-e-clinic.html Tue, 05 Jul 2022 17:25:00 +0530 Hyderabad-based Medley Medical Solutions has announced the formal launch of its virtual clinics branded 'Ananda E-Clinics.' It’s a unique model that enables local pharmacies to offer virtual clinics and facilitate online doctor consultations with patients.   Ananda E-Clinic follows an easy, quick, and simple format that allows it to be set up in every mid-size and large pharmacy as it requires just a kiosk space. From selecting the doctors to consulting with them and getting the medicines as per prescription will all happen at each Ananda E-Clinic Kiosk.   More than 50 pharmacies in Hyderabad have signed up for setting up Ananda e Clinics and the implementation process is on. ]]> <![CDATA[Aurigene inks drug discovery partnership with EQRx]]> https://biospectrumindia.com/news/95/21568/aurigene-inks-drug-discovery-partnership-with-eqrx.html https://biospectrumindia.com/news/95/21568/aurigene-inks-drug-discovery-partnership-with-eqrx.html Tue, 05 Jul 2022 17:00:00 +0530 Aurigene Discovery Technologies, a wholly owned subsidiary of Dr. Reddy’s Laboratories, has announced drug discovery, development and commercialisation partnership with US-based EQRx.   The collaboration combines Aurigene’s small molecule drug discovery platform and EQRx's pioneering business model to accelerate the development of drug candidates in the areas of oncology and immune-inflammatory diseases and improve global access to innovative medicines.   Under the terms of the collaboration agreement, Aurigene and EQRx will collaborate on drug discovery, pre-clinical and clinical development and commercialisation.   Aurigene will lead drug discovery and pre-clinical development efforts, and EQRx will assume responsibility for clinical development, manufacturing, regulatory and commercialisation efforts. The parties would share both funding for the discovery and development of the programmes and financials resulting from the commercialization of any eventual drug candidates. ]]> <![CDATA[Zyla Health raises $1 M funds in pre-Series A round]]> https://biospectrumindia.com/news/95/21565/zyla-health-raises-1-m-funds-in-pre-series-a-round.html https://biospectrumindia.com/news/95/21565/zyla-health-raises-1-m-funds-in-pre-series-a-round.html Tue, 05 Jul 2022 14:10:00 +0530 Zyla Health has raised $1 million in fresh funding as part of its pre-series A round, to accelerate its growth. “Zyla will use the funds to strengthen the leadership and invest in integrating Zyla’s care product across the ecosystem for growth,” said Khushboo Aggarwal Founder & CEO.   Before this fresh raise of funding, Zyla raised capital from leading institutional investors, Kae Capital and Secocha Ventures. The company is targeting 5X growth this year with the latest infusion of funds.  ]]> <![CDATA[US-based Palani launches hygiene range ErasaVir in India]]> https://biospectrumindia.com/news/95/21558/us-based-palani-launches-hygiene-range-erasavir-in-india.html https://biospectrumindia.com/news/95/21558/us-based-palani-launches-hygiene-range-erasavir-in-india.html Mon, 04 Jul 2022 18:45:00 +0530 ErasaVir is redefining what hygiene means in a post-pandemic world. Developed by US-based Palani, the first pair of products (a mouth and nasal spray respectively) aim to protect from harmful pathogens after they enter our bodies.   ErasaVir mouth and nasal sprays can be safely used daily and on a life-long basis. All the ingredients in ErasaVir have been proven to be safe and categorised as GRAS (Generally Recognized as Safe) by the US FDA. In India, these products are approved under the department of AYUSH, owing to the plant origins of their active ingredients.    The ErasaVir platform inactivates (kills) various enveloped viruses (including SARS-CoV-2 and the Flu) and some other pathogens like harmful bacteria on contact, providing complete upper respiratory tract protection. The platform leverages lipid-dissolution technology to physically destabilise and inactivate these pathogens. The mechanism allows ErasaVir to function irrespective of variants and mutations within the viruses and bacteria, which is a massive advantage.  ]]> <![CDATA[CARE Hospitals forays into central India]]> https://biospectrumindia.com/news/95/21557/care-hospitals-forays-into-central-india.html https://biospectrumindia.com/news/95/21557/care-hospitals-forays-into-central-india.html Mon, 04 Jul 2022 17:35:00 +0530 Hyderabad-based CARE Hospitals Group announced its entry into Madhya Pradesh through the acquisition of Indore-based CHL Hospitals.    Jasdeep Singh, Group CEO, CARE Hospitals said, “We welcome CHL Hospitals to the CARE Hospitals network and are excited by the potential to create greater accessibility to high-end clinical care to patients with our combined expertise in central India. This partnership with CHL consolidates our presence further with a leadership position in the key geography of the country."   Rajesh Bhargava, CMD, CHL Hospitals said, “We welcome CARE Hospitals to take the lead in growing CHL Hospitals in Indore and other parts of the state. With the new transition, our teams are looking forth to supporting CARE Hospitals in its endeavour to scale up CHL Hospitals in central India.”   Vishal Bali, Chairman, CARE Hospitals, added, “These cities will also contribute significantly to the rise in healthcare consumption and power the next phase of growth for the healthcare sector."     ]]> <![CDATA[BASF, Permionics introduce high performance face masks]]> https://biospectrumindia.com/news/95/21552/basf-permionics-introduce-high-performance-face-masks.html https://biospectrumindia.com/news/95/21552/basf-permionics-introduce-high-performance-face-masks.html Mon, 04 Jul 2022 10:15:00 +0530 German firm BASF has joined hands with Vadodara-based membrane manufacturer, Permionics Membranes, to extend, for the first time, the application of BASF's Ultrason E polyethersulphone (PESU) polymer into coated fabrics that serve as particulate and bacterial filter for face masks.    The face masks using the fabric as a middle layer are highly breathable, washable and re-usable unlike conventional face masks. They are designed for usage in the Indian healthcare market.    Permionics selected Ultrason E for its coated fabric, Perma Bioshield. The fabric is made by adhering an antimicrobial coating made of Ultrason E to the matrix of a non-woven fabric as a bonded support.    Ultrason E is a high purity material with low gel and oligomer content that ensures a stable membrane manufacturing process. PESU can be used in a wide pH range (0-13) without deterioration. It is especially suitable for the production of durable hollow-fibre membranes and filters for use in the food, beverage, electronics and pharmaceutical industries.     ]]> <![CDATA[Thyrocare launches 20th regional processing lab in Raipur]]> https://biospectrumindia.com/news/95/21551/thyrocare-launches-20th-regional-processing-lab-in-raipur.html https://biospectrumindia.com/news/95/21551/thyrocare-launches-20th-regional-processing-lab-in-raipur.html Sat, 02 Jul 2022 23:05:00 +0530 Thyrocare launched its new Regional Processing Lab (RPL) in Raipur, Chhattisgarh, which is its 20th RPL in India, on the occasion of National Doctors’ Day. Located in Tiara Shopping Mall in Shankar Nagar, the RPL is equipped with unique 24*7 unidirectional sample-processing systems and an automated effluent treatment plant, which ensures safe and effective disposal of biomedical waste with world-class processing for a broad spectrum of diagnostic tests.    The RPL is spread over an area of 3850 sq ft and can process 3000 samples in a day. The laboratory will cater to the testing needs of patients, doctors, diagnostics centres, hospitals, nursing homes and other healthcare facilities in Raipur and surrounding areas.   The 20th RPL of Thyrocare was inaugurated by Dr Manoj Chellani, Chairperson, Medical Disorders in Pregnancy Committee FOGSI 2022-25 and Director of Aayush Test Tube Baby Centre, Raipur. ]]> <![CDATA[ JB Pharma acquires four paediatric brands from Dr Reddy’s Labs]]> https://biospectrumindia.com/news/95/21542/-jb-pharma-acquires-four-paediatric-brands-from-dr-reddys-labs.html https://biospectrumindia.com/news/95/21542/-jb-pharma-acquires-four-paediatric-brands-from-dr-reddys-labs.html Fri, 01 Jul 2022 11:15:00 +0530 JB Pharma has announced its third acquisition of four brands in the calendar year in the paediatric segment – Z&D, Pedicloryl, Pecef and Ezinapi from Dr Reddy’s Laboratories.   All the acquired four brands have their specification in their respective segments. Z&D DS 20 Suspension is a market leader in the zinc sulphate molecule category, used as a nutritional supplement for boosting immunity and for gut related disorders in children, primarily in diarrhoea. Pecef (Cefpodoxime Proxetil) and Pecef Duo (Cefpodoxime Proxetil + Clavulanic Acid Potassium Salt) acquired, have a wide range of SKUs to cater to bacterial infections as well as RTIs (Respiratory Tract Infections) in children.  Ezinapi Cream is a perfect blend of Cetyl myristoleate, Zinc oxide, and D-panthenol - a clinically tested formulation recommended for use as an emollient for diaper rashes in infants. Pedicloryl oral solution (Triclofosq) is used in children in hospital settings for idiopathic pain management.   All four brands are in the paediatric segment with total market size of Rs 1800 crore. The combined sales as per internal estimates were Rs 33 crores for FY 2021-22.   As per the terms of the definitive agreement, JB will take over the manufacturing, marketing and distribution of these brands in India. The complete integration and transition of the brands are expected to be completed in the next two weeks.       ]]> <![CDATA[Akums Drugs bags EU GMP approval for Haridwar-based plants]]> https://biospectrumindia.com/news/95/21541/akums-drugs-bags-eu-gmp-approval-for-haridwar-based-plants.html https://biospectrumindia.com/news/95/21541/akums-drugs-bags-eu-gmp-approval-for-haridwar-based-plants.html Fri, 01 Jul 2022 10:15:00 +0530 Akums Drugs & Pharmaceuticals has recently acquired the stringent European Union (EU) Good Manufacturing Practice (GMP) approval for two of their manufacturing units in Haridwar. The gateway for several new opportunities in the European and other stringent regulatory markets is open to Akums Drugs.    Akums has received EU GMP approval for two of its manufacturing plants. One plant manufactures solid oral dosage forms such as tablets, hard gelatin capsules, powders in sachets, etc. belonging to the general category, and the other manufactures the large-volume and small-volume parenterals range including vials, ampoules, eyedrops, FFS as well as dry powder injections belonging to the penicillin line.      ]]> <![CDATA[Novartis opens manufacturing plant in Maharashtra ]]> https://biospectrumindia.com/news/95/21537/novartis-opens-manufacturing-plant-in-maharashtra-.html https://biospectrumindia.com/news/95/21537/novartis-opens-manufacturing-plant-in-maharashtra-.html Fri, 01 Jul 2022 00:00:00 +0530 Sandoz Technical Operations, a Novartis division, has inaugurated its manufacturing plant for medicines and therapies at Kalwe in Mumbai.   The plant, which marks a new chapter for Sandoz, will further strengthen the company’s operations in India to support growing healthcare needs globally. The new facility will manufacture oral cancer medicines for the global market and will play a key role in enabling the delivery of high-quality cancer treatment.    The manufacturing facility is spread across 32000 sqm, and houses state-of-the-art production technology. Additionally, built on a brownfield, effluent treatment units installed at the plant shape a next-gen environmentally sustainable manufacturing atmosphere.    ]]> <![CDATA[Global investors led by Arpwood acquires majority stake in Sterling Hospitals]]> https://biospectrumindia.com/news/95/21536/global-investors-led-by-arpwood-acquires-majority-stake-in-sterling-hospitals.html https://biospectrumindia.com/news/95/21536/global-investors-led-by-arpwood-acquires-majority-stake-in-sterling-hospitals.html Thu, 30 Jun 2022 14:35:00 +0530 Sterling Addlife India, which operates the Sterling Hospitals chain of multi-speciality hospitals in Gujarat, has been acquired by a global consortium led by Arpwood Partners (Arpwood). The founder of Sterling Hospitals, Girishbhai Patel has retained a minority stake and will continue to be a mentor to Sterling Hospitals.    The spokesperson for Arpwood Partners said, “We will soon announce an experienced CEO who has had a long and distinguished record at one of the largest national healthcare chains. Incidentally, all the three founders of Arpwood are privileged to have pursued post-graduate studies from Ahmedabad and are pleased to renew their association with the state of Gujarat and with its admirable people.”   ]]> <![CDATA[Apex Labs launches advanced fungal infection capsules]]> https://biospectrumindia.com/news/95/21527/apex-labs-launches-advanced-fungal-infection-capsules.html https://biospectrumindia.com/news/95/21527/apex-labs-launches-advanced-fungal-infection-capsules.html Thu, 30 Jun 2022 13:10:00 +0530 Chennai-based Apex Laboratories has launched an advanced form of Itraconazole Capsules Supra Bioavailable 65 and 130 mg, a potent therapeutic choice to effectively control fungal infections. Supra Bioavailable Itraconazole capsules deliver a higher percentage (90 per cent) of active medicine to the biological system, at a lesser dose. The advanced preparation also ensures lesser inter-individual variability which might translate into enhanced efficacy in the management of fungal infections.   Supra Bioavailable Itraconazole 65 mg & 130 mg capsules are prepared by Top spray granulation technology which is used to improve the dissolution rate of Itraconazole. It contains a solid dispersion of Itraconazole in a uniform non-pellet formulation. This novel technology enhances the bioavailability of poorly soluble drugs. The Technology utilises a solid dispersion of drug in a polymer to improve the absorption in the gastrointestinal tract to achieve “super bioavailability” compared to conventional preparations. ]]> <![CDATA[Zydus joins End Drug Shortages Alliance in US]]> https://biospectrumindia.com/news/95/21523/zydus-joins-end-drug-shortages-alliance-in-us.html https://biospectrumindia.com/news/95/21523/zydus-joins-end-drug-shortages-alliance-in-us.html Thu, 30 Jun 2022 00:00:00 +0530 Zydus Pharmaceuticals (USA) Inc., a wholly owned subsidiary of Ahmedabad-based Zydus Lifesciences has joined a new coalition of diverse stakeholders to address drug shortages in the United States. The End Drug Shortages Alliance provides a forum for key stakeholders to take strategic aim at one of healthcare's more pressing and enduring issues, drug shortages that disrupt patient care. Speaking on the development, Dr. Sharvil Patel, Managing Director, Zydus Lifesciences Ltd., said, "Through our innovations and patient-centric approach, we have been committed to providing novel solutions to address unmet healthcare needs of the patients. Providing access to medicines is an important part of our core purpose which is to empower people with the freedom to live healthier and more fulfilled lives. Partnering with diverse stakeholders through this alliance takes us closer to this goal." The End Drug Shortages Alliance was launched in 2021 to bring together industry stakeholders, including healthcare providers, group purchasing organizations, manufacturers, distributors and other industry thought leaders and champions. The efforts of the alliance focus on improving access to medications through greater transparency across market participants, leading to improved quality manufacturing of medications and production of additional supply.   ]]> <![CDATA[US-based HDT Bio’s COVID-19 vaccine gets regulatory approval in India]]> https://biospectrumindia.com/news/95/21525/us-based-hdt-bios-covid-19-vaccine-gets-regulatory-approval-in-india.html https://biospectrumindia.com/news/95/21525/us-based-hdt-bios-covid-19-vaccine-gets-regulatory-approval-in-india.html Thu, 30 Jun 2022 00:00:00 +0530 Indian regulators have issued an Emergency Use Approval for Gemcovac, a groundbreaking COVID-19 vaccine based on the technology of Seattle biotech HDT Bio Corp. The vaccine uses self-amplifying RNA (saRNA), which replicates itself following administration and is thus effective at extremely low doses. In addition, it is stable at refrigerator temperatures unlike current mRNA vaccines, which require ultra-cold storage. Gemcovac becomes the first saRNA vaccine ever approved for human use. HDT Bio’s vaccine is currently undergoing clinical trials in the U.S., Brazil, and South Korea. “Our saRNA vaccine is a game changer,” said HDT Bio CEO Steve Reed. “This technology can stimulate an immune response with a dose of up to 20 times lower than current vaccines, which enhances safety, lowers costs, and increases production speed. Also, the vaccine can be transported at refrigerator temperature, or even freeze-dried and shipped without temperature control. The combination of lower cost and higher stability will allow HDT Bio to take a truly global distribution approach.” ]]> <![CDATA[Wunderman Thompson India launches WT Health]]> https://biospectrumindia.com/news/95/21514/wunderman-thompson-india-launches-wt-health.html https://biospectrumindia.com/news/95/21514/wunderman-thompson-india-launches-wt-health.html Tue, 28 Jun 2022 22:15:00 +0530 Wunderman Thompson India has officially launched Wunderman Thompson Health (WT Health). With a multidisciplinary team of 100 plus, WT Health has experts across creative, medico legal, compliance and public health. WT Health will be focussed on driving excellence in an evolving healthcare sector and delivering products that are insight-driven and innovative to make a positive impact with key stakeholders.   ]]> <![CDATA[Themis Medicare unveils VIRALEX to treat COVID-19 variants]]> https://biospectrumindia.com/news/95/21513/themis-medicare-unveils-viralex-to-treat-covid-19-variants.html https://biospectrumindia.com/news/95/21513/themis-medicare-unveils-viralex-to-treat-covid-19-variants.html Tue, 28 Jun 2022 18:35:00 +0530 Mumbai-based Themis Medicare has launched VIRALEX- Inosine Pranobex to treat COVID-19, which is effective irrespective of the new variants. The benefit of VIRALEX is that it is effective not just in COVID-19 but also in other viral respiratory infections. The safety and efficacy have been demonstrated through a double-blind, randomised placebo-control (considered a gold standard in clinical research) multicentre trial in India with the drug showing significantly early clinical response and cure. The trials were conducted during the Delta wave of COVID-19 and showed early improvement and complete relief from symptoms in patients who received VIRALEX.The oral medication is available in the form of a 500 mg tablet.VIRALEX- Inosine Pranobex has been approved for the treatment of influenza and other Acute Viral Respiratory Infections (AVRI) including COVID -19, mucocutaneous herpes, genital wart and Subacute Sclerosing Panencephalitis (SSPE) by the Drug Controller General of India (DCGI). ]]> <![CDATA[Glenmark Pharma, USA acquires approved ANDAs from Wockhardt]]> https://biospectrumindia.com/news/95/21506/glenmark-pharma-usa-acquires-approved-andas-from-wockhardt.html https://biospectrumindia.com/news/95/21506/glenmark-pharma-usa-acquires-approved-andas-from-wockhardt.html Tue, 28 Jun 2022 10:35:00 +0530 Glenmark Pharmaceuticals announced that its fully owned subsidiary Glenmark Pharmaceuticals Inc, USA (Glenmark) has acquired the approved Abbreviated New Drug Applications (ANDAs) for Famotidine Tablets USP, 10 mg and 20 mg (OTC), Cetirizine Hydrochloride Tablets USP, 5 mg and 10 mg (OTC), Lansoprazole Delayed-Release Capsules USP, 15 mg (OTC) and Olopatadine Hydrochloride Ophthalmic Solution USP, 0.1 per cent (OTC) in the US from Wockhardt.Sanjeev Krishan, President of Glenmark Pharmaceuticals, USA, said, "Our acquisition of these ANDAsrepresents the continued expansion of our business into the OTC market here in the US and our commitment to ensuring patients have access to high quality, affordable medicines.” ]]> <![CDATA[Dr Reddy's Labs acquires injectable product portfolio from Eton Pharma]]> https://biospectrumindia.com/news/95/21500/dr-reddys-labs-acquires-injectable-product-portfolio-from-eton-pharma.html https://biospectrumindia.com/news/95/21500/dr-reddys-labs-acquires-injectable-product-portfolio-from-eton-pharma.html Mon, 27 Jun 2022 18:20:00 +0530 Hyderabad-based Dr Reddy’s Laboratories has acquired a portfolio of branded and generic injectable products from US-based Eton Pharmaceuticals. The portfolio includes the Biorphen (phenylephrine hydrocholoride) Injection and Rezipres (ephedrine hydrochloride) Injection NDAs with nine separate combinations of strengths and presentations and one first-to-file approved ANDA for Cysteine Hydrochloride for the US. One strength each of Biorphen and Rezipres are currently commercially available in the US. The acquisition will complement Dr Reddy’s US institutional business with limited competition in injectable products.Under the terms of the agreement, Dr Reddy’s acquired the Eton portfolio for an upfront payment of approximately $5 million in cash, plus contingent payments of up to $45 million. The acquisition supports Dr Reddy’s efforts to accelerate and expand affordable medications for patients. ]]> <![CDATA[INCOR Group forms JV with Renovis Pharma]]> https://biospectrumindia.com/news/95/21496/incor-group-forms-jv-with-renovis-pharma.html https://biospectrumindia.com/news/95/21496/incor-group-forms-jv-with-renovis-pharma.html Mon, 27 Jun 2022 15:30:00 +0530 Hyderabad-based conglomerate INCOR Group and Renovis Labs have entered into a new joint venture (JV) ‘INCOR Renovis’. The new company will focus on developing cost-effective and green technologies in the areas of human health, animal health and agriculture and will work towards making India self-reliant in manufacturing medicines under the AatmaNirbhar Bharat Abhiyan. INCOR Renovis Pharma has come up with a new innovative methodology wherein it uses a combination of chemical, biological and engineering solutions to create high-quality, cheaper and safer medicines. The second major goal of the company is set out to achieve in its 10-year long-term plan of reducing carbon emissions associated with drug production and pharmaceutical development processes. The company plans to use automation in manufacturing to realise this vision and is in the process of filing numerous patents for its inventions and discoveries. ]]> <![CDATA[Nitin Gadkari inaugurates Wellness Forever’s first store in Nagpur]]> https://biospectrumindia.com/news/95/21492/nitin-gadkari-inaugurates-wellness-forevers-first-store-in-nagpur.html https://biospectrumindia.com/news/95/21492/nitin-gadkari-inaugurates-wellness-forevers-first-store-in-nagpur.html Mon, 27 Jun 2022 11:15:00 +0530 Wellness Forever Medicare, an omnichannel retail pharmacy with a network in western India, has announced the opening of two stores in Nagpur to further its presence in Maharashtra. The chain also has a presence in Goa and Karnataka.   The stores are located in Nagpur at Darodkar Square and Trimurti Nagar. The stores aim to provide a distinctive shopping experience, with a wide assortment of pharmaceutical and lifestyle products which include FMCG products, nutraceuticals, medical equipment along with medicines.    With these stores, Wellness Forever brings a differentiated pharmacy experience for the citizens of Nagpur, along with day and night operations to cater to their needs 24x7. A grand opening event was held at the Darodkar Square store in Nagpur, which was graced by Nitin Gadkari, Minister of Road Transport & Highways, Government of India as the guest of honour.          ]]> <![CDATA[Dermatology drugs see 30% jump in sales in May’22: Akums Drugs]]> https://biospectrumindia.com/news/95/21494/dermatology-drugs-see-30-jump-in-sales-in-may22-akums-drugs.html https://biospectrumindia.com/news/95/21494/dermatology-drugs-see-30-jump-in-sales-in-may22-akums-drugs.html Mon, 27 Jun 2022 00:00:00 +0530 Akums Drugs & Pharmaceuticals believes that the dermatology sector is set to boom in India due to people facing factors such as lifestyle changes, environmental changes, pollution, and also short-term factors like heat, humidity and pollution as they resume their daily activities as pandemic-led concerns subside.According to a recent AWACS AIOCD report, the segment has increased to 30 per cent in MAT May 2022. This spike in dermatology drug sales is a result of the increase in demand for anti-acne, emollients, hair restorers, anti-fungal and skin brightening formulations, as people are resuming their normal activities. This sales trend is due to various factors like stress, humidity, heat, pollution, and long COVID complications that are resulting in myriad skin- and hair-related conditions. Akums Drugs also sees this development coinciding with the return to normal conditions, with people finally stepping out of their homes, consulting doctors to resume pending treatments and wanting to take care of their skin & hair again in the face of changing climatic conditions and higher levels of pollution. In India, the anti-infectives, cardiac and diabetes segments have been known to dominate the market; but Akums believes dermatology is strengthening its presence gradually. As per the report, the segment is valued at Rs 11,043 crore in May 2022, and it looks to be one of the fastest-growing therapies going forward. ]]> <![CDATA[Ahammune Biosciences, Veeda conduct human studies for vitiligo drug]]> https://biospectrumindia.com/news/95/21488/ahammune-biosciences-veeda-conduct-human-studies-for-vitiligo-drug.html https://biospectrumindia.com/news/95/21488/ahammune-biosciences-veeda-conduct-human-studies-for-vitiligo-drug.html Fri, 24 Jun 2022 19:50:00 +0530 Pune-based Ahammune Biosciences and Ahmedabad-based Veeda Clinical Research have partnered for the first in human studies with Ahammune’s investigational new drug- AB1001, being developed as a topical therapy for Vitiligo.    The preliminary research for AB1001 was conducted at Ahammune’s R&D laboratory based out of Pune which demonstrates that this drug candidate is both safe and efficacious for vitiligo treatment. Both the companies – Ahammune Biosciences & Veeda Clinical Research – anticipate that this new drug has a great potential for the treatment of vitiligo.    Speaking about the new treatment, Co-founder and Executive Director of Ahammune Biosciences Private Limited, Dr. Parul Ganju, said, “Vitiligo is a debilitating disease where autoimmune attack to melanocytes results in the formation of white patches. The chronic nature of the disease and the lack of treatment options is distressing for the patients. Understanding this lacuna, we have identified new intervention pathway for the disease and have developed therapeutic molecules targeting this pathway. Our preclinical studies establish that our molecules have the potential to stop disease progression and also support repigmentation." ]]> <![CDATA[Data security key for pharma companies in India: Deloitte–DSCI report]]> https://biospectrumindia.com/news/95/21482/data-security-key-for-pharma-companies-in-india-deloittedsci-report.html https://biospectrumindia.com/news/95/21482/data-security-key-for-pharma-companies-in-india-deloittedsci-report.html Thu, 23 Jun 2022 22:35:00 +0530 With the increased focus on digital transformation, pharma companies in India are prioritising data security, finds a Deloitte Touche Tohmatsu India (Deloitte India) and Data Security Council of India (DSCI) report. The report further says ransomware attacks and IP and data theft were the top cybersecurity concerns for the sector, both in India and globally.    DSCI and Deloitte conducted more than 25 expert discussions between August 2021 and March 2022, where leading pharma companies and industry experts, both global and in India, shared their views on the pulse of the sector and the rising focus on cybersecurity.   As part of the cybersecurity strategy, along with data protection and resilience, identity and access management, OT security, offensive security capabilities, and better threat detection and response are some focus areas for pharma companies in India. Furthermore, 70 per cent of the leading pharma companies highlighted their focus on a zero-trust approach with the need for a clear roadmap over the next two years, around network, data, and access.   The report lists certain cybersecurity considerations for pharma companies. It includes better cyber preparedness, cyber due diligence in M&As, along with having cyber insurance. Apart from a zero-trust approach, adopting a security-by-design, resilient-by-design, and safety-by-design approach has also been recommended. Strengthening the supply chain and OT security, enhancing monitoring and awareness, and empowering CISO to effectively manage cyber risks across functions are also some considerations for pharma companies in India.  ]]> <![CDATA[Lupin collaborates with Accenture for data-driven initiative]]> https://biospectrumindia.com/news/95/21481/lupin-collaborates-with-accenture-for-data-driven-initiative.html https://biospectrumindia.com/news/95/21481/lupin-collaborates-with-accenture-for-data-driven-initiative.html Thu, 23 Jun 2022 22:30:00 +0530 Pharmaceutical firm Lupin has collaborated with Accenture to enable its data-driven transformation journey for improved business agility, performance, and operational efficiency. Accenture has deployed a digital platform based on SAP S/4HANA, providing decision-makers with real-time visibility into integrated data from multiple sources including supply chain, people and sales networks spread across 100+ countries and its fifteen manufacturing and research facilities in India, the US, Brazil and Mexico. The consolidated view of global business operations and performance has enabled informed decision-making. SAP Fiori apps have also helped enhance the user experience for Lupin employees with simple and easy-to-access data models and analytical reports. Sreeji Gopinathan, CIO, Lupin, "Through our collaboration with Accenture, we will unlock the value of enterprise data to increase efficiencies and accelerate innovation across all our functions and processes, including manufacturing, testing, supply chain, and finance and accounting.” Sameer Amte, lead for Accenture’s Life Sciences practice in India, said, “We are helping Lupin become an intelligent enterprise by enabling data-driven decisions that will help accelerate product innovation and enable faster market access.” ]]> <![CDATA[SRL Diagnostics launches reference laboratory in Chennai]]> https://biospectrumindia.com/news/95/21475/srl-diagnostics-launches-reference-laboratory-in-chennai.html https://biospectrumindia.com/news/95/21475/srl-diagnostics-launches-reference-laboratory-in-chennai.html Wed, 22 Jun 2022 19:45:00 +0530 SRL Diagnostics announced the launch of a state-of-the-art reference laboratory at Ashok Nagar, Chennai. The laboratory sprawled over 20,000 sq ft can conduct more than one lakh tests each month, ranging from the most routine tests to esoteric and genetic tests.    The laboratory will also be the ‘Center of Excellence’ for transplant immunology. Apart from highly specialized compatibility testing and evaluation needed for successful transplants, the centre of excellence will also focus on research, academics, knowledge sharing and skill-building. The lab also houses all clinical laboratory departments including clinical chemistry, haematology, histopathology, biochemistry, flow cytometry, microbiology etc.      ]]> <![CDATA[Hyd-based Austrak launches nephrology and urology division]]> https://biospectrumindia.com/news/95/21474/hyd-based-austrak-launches-nephrology-and-urology-division.html https://biospectrumindia.com/news/95/21474/hyd-based-austrak-launches-nephrology-and-urology-division.html Wed, 22 Jun 2022 17:35:00 +0530 Hyderabad-based pharma company Austrak has launched its new super speciality division to focus on around 73 valued products in nephrology and urology. With a strong presence in the segment of ophthalmology for the last 12 years, Austrak aims to supply products and services that significantly improve people's lives by helping to prevent, diagnose and treat disease.   Vittal, Chairman, Austrak said, "We aim to develop and market high-quality speciality, therapeutic and medical products to cure critical illnesses like Chronic Kidney Disease (CKD) and urology-related ailments with their high prevalence, morbidity and mortality and ease sufferings."         ]]> <![CDATA[Clevergene inks MoU with RGCB to set up genomic centre in Kerala]]> https://biospectrumindia.com/news/95/21472/clevergene-inks-mou-with-rgcb-to-set-up-genomic-centre-in-kerala.html https://biospectrumindia.com/news/95/21472/clevergene-inks-mou-with-rgcb-to-set-up-genomic-centre-in-kerala.html Wed, 22 Jun 2022 17:10:00 +0530 Clevergene Biocorp, a deep-tech genomics company, has signed a Memorandum of Understanding (MoU) with The Rajiv Gandhi Centre for Biotechnology (RGCB), to establish a state-of-the-art genomics centre at Thiruvananthapuram.    In a first of its kind in Kerala, the state-of-the-art genomics centre will house the latest DNA sequencing equipment like the Illumina NovaSeq and other allied infrastructure to support cutting-edge research in plant biotechnology, infections, cancer and other chronic diseases.    The services of this high-throughput genomics centre will be open for use in research to other institutes and industries and will provide services like gene expression analysis, epigenetics and genome analysis including that of the COVID-19 virus.    The MoU was represented by Professor Chandrabhas Narayana, Director, RGBC, S Mohanan Nair, Chief Controller, RGBC Dr TR Santhosh Kumar and Tony Jose, CEO, Clevergene Biotech and Shiv Mohan Singh Chief Commercial Officer, Clevergene Biotech. ]]> <![CDATA[Ambee, VitalFlo to provide respiratory health monitoring solution]]> https://biospectrumindia.com/news/95/21464/ambee-vitalflo-to-provide-respiratory-health-monitoring-solution.html https://biospectrumindia.com/news/95/21464/ambee-vitalflo-to-provide-respiratory-health-monitoring-solution.html Tue, 21 Jun 2022 22:25:00 +0530 Bengaluru-based Ambee, a global platform for hyperlocal environmental data, has partnered with US-based digital health company VitalFlo, to provide air quality data and respiratory health monitoring solutions.    VitalFlo is a digital health company that helps clinical teams measure and monitor the respiratory health of their patients. Using environmental data collected by Ambee, VitalFlo enables clinical teams to provide proactive and responsive management of respiratory diseases and conditions. Through advanced trends, patient status alerts, and detailed analytics, clinicians can forecast potential environmental triggers and adjust patient action plans accordingly, improving the quality of life for all those afflicted.   Ambee’s air quality data helps visualise and quantify ambient air pollution at any given location, down to the postcode and neighbourhood level. ]]> <![CDATA[Tainted CDSCO official under CBI net for bribery charges]]> https://biospectrumindia.com/news/95/21467/tainted-cdsco-official-under-cbi-net-for-bribery-charges.html https://biospectrumindia.com/news/95/21467/tainted-cdsco-official-under-cbi-net-for-bribery-charges.html Tue, 21 Jun 2022 00:00:00 +0530 The Central Bureau of Investigation (CBI) recently arrested Joint Drugs Controller S Eswara Reddy and Dinesh Dua, Director at Synergy Network India who allegedly took part in bribery. Also in the news was L Praveen Kumar, the Associate Vice President of Biocon Biologics.   Reddy, posted at the Central Drugs Standard Control Organisation (CDSCO) in New Delhi and Dua were recently nabbed during a trap operation by the CBI while the alleged bribe exchange was going on.    CBI also filed FIR against Guljit Sethi, Director, Bioinnovat Research Services, as well as Assistant Drug Inspector Animesh Kumar under IPC sections of criminal conspiracy, cheating, forgery and corruption.   Biocon came up with clarifications on the recent happenings. Kiran Mazumdar Shaw, CMD, Biocon said, "It is unfortunate that Biocon Biologics has been named in this controversy. We reiterate that we strongly condemn all acts of bribery and corruption and have been cooperating with the investigation agency.”   Shares of Biocon tanked after allegations of bribing. Stocks traded down 3.66 per cent at Rs 313.20 on the BSE.   CDSCO which till now has been respected for its way of handling the core issues of the sector had its image marred with corrupt officials taking things for granted.    ]]> <![CDATA[Glenmark launches fixed-dose combination drug for asthma]]> https://biospectrumindia.com/news/95/21445/glenmark-launches-fixed-dose-combination-drug-for-asthma.html https://biospectrumindia.com/news/95/21445/glenmark-launches-fixed-dose-combination-drug-for-asthma.html Mon, 20 Jun 2022 00:00:00 +0530 Mumbai-based Glenmark Pharmaceuticals has launched the novel fixed-dose combination (FDC) drug - Indacaterol + Mometasone for patients suffering from uncontrolled asthma, in India. The company has launched this FDC under the brand name Indamet. The drug will be available in three strengths with a fixed dose of Indacaterol 150 mcg and variable doses of Mometasone 80 mcg, 160 mcg, and 320 mcg respectively, to be taken once daily.While speaking on the development, Alok Malik, Group Vice President & Head, India Formulations – Glenmark Pharmaceuticals said, “Respiratory is a key focus area for Glenmark and the company leads from the front in providing access to the latest treatment options to patients. We are proud to introduce this novel fixed-dose combination Indamet, which is the first of its kind in India; offering a world-class and affordable treatment option to both adults and adolescents 12 years of age and older suffering from uncontrolled asthma.”Glenmark is the first company in India to market the innovative FDC of Indacaterol, a long-acting beta-agonist and Mometasone Furoate, an inhaled corticosteroid which is approved by the DCGI (Drug Controller General of India).Indamet will help in the management of uncontrolled asthma by improving lung function, better symptom control and reducing exacerbations. ]]> <![CDATA[Avesthagen partners with Wipro to launch genetic tests for cancers]]> https://biospectrumindia.com/news/95/21456/avesthagen-partners-with-wipro-to-launch-genetic-tests-for-cancers.html https://biospectrumindia.com/news/95/21456/avesthagen-partners-with-wipro-to-launch-genetic-tests-for-cancers.html Mon, 20 Jun 2022 00:00:00 +0530 Bengaluru-based Avesthagen has entered into a four-year strategic alliance with Wipro for making its genetic testing portfolio commercial. The portfolio includes genome panels offering highly specific, disease-centric analysis for conditions including cancers, neurodegenerative diseases, autoimmune disorders and rare disease conditions. Together, Avesthagen and Wipro will execute the project titled, “Cancer Risk Assessed by NGS profiling of Circulating free DNA and RNA for Lung Cancer Project related Genomics Sequencing services.” The Project will be jointly led by Avesthagen and Wipro where Wipro’s state-of-the-art Lifesciences lab will perform initial processing of the samples, generate data on the latest Next-generation sequencing platforms, compile genomic sequences and analyze detailed molecular information using computational AI/ML based tools. Wipro’s expertise across multi-disciplinary areas of genomics and biomarker discovery, will help Avesthagen in building well-regulated workflows during the development of CALiBRx gene panels. The tests would be predominantly offered in super specialty clinics and hospitals that focus on oncological disorders. It will later strategically release diagnostic tools that address upper respiratory cancers such as head, neck and esophageal cancers. In the medium and long term, the project would lead to a new generation of genome-led medicine. CALiBRxO - the 624 gene panel - will be available in the market from Q3 2022 and will target cancers and neurological conditions. It presents a targeted screening approach of 624 genes implicated in oncological conditions.  The India launch will be followed by expansion in South Asia, Southeast Asia and the MENA region in Q4 2022. Over the next decade, it will license its IP and product outcomes to digital health, pharma and food companies and Fortune 500 biotech companies. ]]> <![CDATA[Cadila Pharma opens new formulation development lab]]> https://biospectrumindia.com/news/95/21457/cadila-pharma-opens-new-formulation-development-lab.html https://biospectrumindia.com/news/95/21457/cadila-pharma-opens-new-formulation-development-lab.html Mon, 20 Jun 2022 00:00:00 +0530 Ahmedabad-based Cadila Pharmaceuticals’ new formulation development laboratory was inaugurated on 19th June by an Ethiopian government official during a high-level Ethiopian delegation’s visit to the company’s state-of-the-art plant in Dholka. H E Dr Tizita Mulugeta Yimam, Ambassador Extraordinary and Plenipotentiary of the Federal Democratic Republic of Ethiopia to India, inaugurated the formulation development laboratory along with Heran Gerba, Director General of the Ethiopian Food and Drug Administration, Dr. HG Koshia, Gujarat’s FDCA commissioner, and other officials. The ground floor of the formulation development laboratory is focused on solid orals, the first floor on injections, while the second floor houses the analytical lab. “Cadila has a plant in Ethiopia. We need to work closely to maintain the relationship and to support each other. Ethiopia offers great opportunities for drug companies and for Cadila Pharma to expand its facilities in Ethiopia,” said Ambassador Tizita Mulugeta Yimam. The delegation also visited Cadila Pharmaceuticals’ corporate campus at Bhat.     ]]> <![CDATA[BPL Medical Technologies partners with AyuRythm]]> https://biospectrumindia.com/news/95/21454/bpl-medical-technologies-partners-with-ayurythm.html https://biospectrumindia.com/news/95/21454/bpl-medical-technologies-partners-with-ayurythm.html Sat, 18 Jun 2022 21:50:00 +0530 BPL Medical is joining hands with AyuRythm, an IAN-backed innovative startup to simplify healthcare while enabling access to the most ancient and time-tested vedic sciences.   The collaboration will enable users to experience wellness on a much deeper level that allows for a more joyful and truly healthy and preventive way of living.   With the integration of AyuRythm app with the BPL pulse oximeter, BP meters and weighing machine, AyuRythm not only blends modern measurement techniques with Ayurvedic assessments (Naadi Pariksha), but also helps BPL customers to get personalised Ayurvedic wellness solutions.   "This partnership is truly ‘Samasya se Samadhaan tak’ providing a holistic approach in bringing access to smart and modern diagnostic healthcare solutions to the fingertips of the users” says Abhilesh, CEO of AyuRythm.     ]]> <![CDATA[Piramal Pharma Solutions expands API capabilities at Digwal]]> https://biospectrumindia.com/news/95/21438/piramal-pharma-solutions-expands-api-capabilities-at-digwal.html https://biospectrumindia.com/news/95/21438/piramal-pharma-solutions-expands-api-capabilities-at-digwal.html Wed, 15 Jun 2022 10:40:00 +0530 Piramal Pharma's Pharma Solutions business, a leading Contract Development and Manufacturing Organization (CDMO), has announced that the company's site in Digwal in the state of Telangana has implemented various tools to unlock Active Pharmaceutical Ingredient (API) manufacturing capacity and support client needs in drug development and on-patent projects.    Now, Digwal's R&D capabilities are being further strengthened, with approximately 20 new fume hoods coming online to support services projects. As a result, the site has recently partnered with clients on more than a dozen programmes, including several which have been commercially launched and others that are under registration with the regulator.    The Digwal site is equipped with a 'Zero Liquid Discharge' facility to ensure all liquid waste gets adequately treated in-house and recycled back to utilities. The solvent recovery infrastructure has also been upgraded, resulting in increased distillation efficiency and a reduction in solvent consumption.    In addition to the increased reactor capacity, the Digwal site will benefit from infrastructure upgrades that include a renovated administration block, a new canteen facility, Quality Control lab revamp, and more. The consolidation and creation of a centralised new warehouse for the storage of finished goods that features a warehouse management system (WMS) are currently underway. ]]> <![CDATA[Cipla, DNDi launch 4-in-1 antiretroviral treatment for children with HIV in SA]]> https://biospectrumindia.com/news/95/21432/cipla-dndi-launch-4-in-1-antiretroviral-treatment-for-children-with-hiv-in-sa.html https://biospectrumindia.com/news/95/21432/cipla-dndi-launch-4-in-1-antiretroviral-treatment-for-children-with-hiv-in-sa.html Tue, 14 Jun 2022 16:45:00 +0530 The South African Health Products Regulatory Authority (SAHPRA) has approved a sweet-tasting, heat-stable, ‘4-in-1’ fixed-dose combination of four antiretroviral (ARV) treatments composed of abacavir, lamivudine, lopinavir, and ritonavir that is specifically designed for infants and young children with HIV. This combination treatment has been developed by pharmaceutical firm Cipla and the not-for-profit Drugs for Neglected Diseases initiative (DNDi).    The new formulation represents a significant improvement over protease inhibitor-containing paediatric ARV formulations that have been used in South Africa for decades. It does not require refrigeration, has a sweet taste and is easy to administer to infants and children of different weights and ages, a major improvement for both children and their caregivers over previously available formulations.    The ‘4-in-1’ combination contains an antiretroviral combination that is recommended by the World Health Organization (WHO) as an alternative first-line regimen for infants and young children with HIV – in the form of granule-filled capsules.    The 4-in-1 was developed and registered with the financial support of Unitaid; the French Development Agency; the Swiss Agency for Development and Cooperation; Médecins Sans Frontières International; the UBS Optimus Foundation; the Monegasque Cooperation for Development; MSF Norway; the Spanish Agency for International Development Cooperation; and other private foundations and individuals.   ]]> <![CDATA[AIMIL Pharma rolls out aggressive expansion plans for int'l market]]> https://biospectrumindia.com/news/95/21402/aimil-pharma-rolls-out-aggressive-expansion-plans-for-intl-market.html https://biospectrumindia.com/news/95/21402/aimil-pharma-rolls-out-aggressive-expansion-plans-for-intl-market.html Fri, 10 Jun 2022 17:50:00 +0530 AIMIL Pharmaceuticals has announced its strategic expansion in the international markets. The company aims to expand its operations into 25 countries, including Europe, the CIS region, the Middle East, Africa, and the Indian Ocean islands.   Dr Ikshit Sharma, Director, AIMIL Pharmaceuticals said, "This expansion plan is in line with the ever-increasing global demand for authentic science-based ayurvedic products for better health. Our products with ECOCERT certified organic herbs would ensure the delivery of premium quality, safe and result-oriented products across various categories such as healthcare, personal care, wellness, and veterinary sectors. We aim to introduce more innovative products as per markets' needs and target 100 countries in the next two financial years. We have also constituted a team headed by Amit Dixit, Global CEO to enhance our focus on international business and expect to generate a revenue of $15 million from this vertical in the next five years." ]]> <![CDATA[Gufic Biosciences unveils dual-chamber IV bags ]]> https://biospectrumindia.com/news/95/21413/gufic-biosciences-unveils-dual-chamber-iv-bags-.html https://biospectrumindia.com/news/95/21413/gufic-biosciences-unveils-dual-chamber-iv-bags-.html Fri, 10 Jun 2022 17:30:00 +0530 Pharma player Gufic Biosciences has targeted to capture a major share of Rs 3000-crore lyophilised antibiotics antifungal market in India. The company has launched New Drug Delivery System: Dual Chamber Bags at an affordable price first time in India.   Gufic Biosciences has collaborated with its French counterpart to manufacture this new technology indigenously in India. The dual-chamber bags launched by Gufic Biosciences are 2-Chamber IV Bags made up of polypropylene (DEHP free) with a peelable aluminium foil allowing the storage of unstable drugs which need a reconstitution just before the administration to the patient. The peelable seal separates lyophilised (or powder) drugs and the diluent. Moreover, the product complies with the US and EU pharmacopoeias and it is manufactured in ISO7 clean room under cGMP.  ]]> <![CDATA[Bengaluru-based Aurigene lays focus on developing novel cancer therapies]]> https://biospectrumindia.com/news/95/21409/bengaluru-based-aurigene-lays-focus-on-developing-novel-cancer-therapies.html https://biospectrumindia.com/news/95/21409/bengaluru-based-aurigene-lays-focus-on-developing-novel-cancer-therapies.html Fri, 10 Jun 2022 13:10:00 +0530 US-based Olema Pharmaceuticals and Bengaluru-based Aurigene Discovery Technologies, a wholly owned subsidiary of Dr. Reddy’s Laboratories, have announced an exclusive global license agreement to research, develop and commercialise novel small molecule inhibitors of an undisclosed oncology target.   Under the terms of the agreement, Olema will make an upfront licensing payment of $8 million for rights to a pre-existing Aurigene programme. Aurigene will be eligible for up to $60 million in potential clinical development and regulatory milestones and up to $370 million in potential commercial milestones, as well as royalties ranging from the mid-single digits to the low double digits based on annual net sales.    During the research term, Olema will contribute funding to Aurigene to facilitate ongoing discovery efforts. Olema and Aurigene will jointly direct further preclinical work and, if successful, Olema will lead clinical development as well as regulatory and commercial activities. Olema continues to be well capitalised with sufficient cash to fund our planned research and development operations into the second half of 2024. ]]> <![CDATA[InnoPack Pharma Confex discuss ways to strengthen innovation in packaging]]> https://biospectrumindia.com/news/95/21407/innopack-pharma-confex-discuss-ways-to-strengthen-innovation-in-packaging.html https://biospectrumindia.com/news/95/21407/innopack-pharma-confex-discuss-ways-to-strengthen-innovation-in-packaging.html Fri, 10 Jun 2022 09:30:00 +0530 CPhI Conferences’ 11th Annual Innopack Pharma Confex presented by West Pharmaceutical Services commenced with the focus on strengthening the pharmaceutical packaging industry.   The two-day pharma confex held in Mumbai, on 9 & 10 June, was marked by the presence of key dignitaries including Dr Hemant G Koshia, Commissioner, Food & Drugs Control Administration, Gujarat ; Bart de Jong, Consulate General of the Kingdom of The Netherlands; KG Ananthakrishnan, Director General, OPPI; AVPS Chakravarthi Global Ambassador, WPO; Yogesh Mudras, MD, Informa Markets in India and Ranjith Paul, Group Director, Informa Markets in India.    The first day of the Innopack Pharma Confex, highlighted that innovation and sustainability are the need of the hour for the development of the pharma packaging industry. Over 40 exhibitors, 40 speakers and trainers participated at the Confex and over 100 nominations for the awards. The event witnessed the presence of various policy makers, industry captains from associations, and the participation of leaders from top pharma and biopharma companies.  ]]> <![CDATA[Tata Motors delivers 965 units of ambulances to MP govt]]> https://biospectrumindia.com/news/95/21406/tata-motors-delivers-965-units-of-ambulances-to-mp-govt.html https://biospectrumindia.com/news/95/21406/tata-motors-delivers-965-units-of-ambulances-to-mp-govt.html Thu, 09 Jun 2022 22:10:00 +0530 Tata Motors delivered 965 units of Tata Winger Ambulance to the ‘108 ambulance service project’ – an emergency response service programme initiated by the Government of Madhya Pradesh’s Ministry of Health and Family Welfare, under the National Rural Health Mission.The Tata Winger Ambulance will now be a part of emergency transportation care working across the state of Madhya Pradesh.As part of the scheme, the feature-rich Tata Winger ambulance has two applications in the project. First, ‘Sanjeevani’ - an EMAS (Emergency Media Ambulance Service) which can be booked via an exclusive ‘MP 108 Sanjeevani’ app across the state of Madhya Pradesh. Tata Winger’s Basic and Advanced Life Support Ambulances will be used as Sanjeevani. Second, ‘Janani Express’, a dedicated Type B (patient transport) Tata Winger ambulance service for women.Tata Motors has supplied the Winger Ambulance for COVID-19 vaccination drives in Gujarat, Lucknow, Jamshedpur, Dharwad, Gandhinagar and Pantnagar. With the ongoing global pandemic, the versatile Tata Winger ambulance is also engineered especially for COVID-19 patient transportation, with a driver partition. Tata Motors offers the most comprehensive range of ambulances from Magic Express Ambulance, Winger Ambulance and LP410 Ambulance, with a double stretcher. ]]> <![CDATA[GARDP supports Bugworks in assessing safety of new antibiotic compound]]> https://biospectrumindia.com/news/95/21405/gardp-supports-bugworks-in-assessing-safety-of-new-antibiotic-compound.html https://biospectrumindia.com/news/95/21405/gardp-supports-bugworks-in-assessing-safety-of-new-antibiotic-compound.html Thu, 09 Jun 2022 00:00:00 +0530 The Global Antibiotic Research and Development Partnership (GARDP) and Bengaluru-based Bugworks, a key player in the global antimicrobial resistance (AMR) innovation ecosystem, are collaborating on a study to assess the safety and tolerability of a new class of broad-spectrum antibiotic compounds aimed at treating serious infections caused by multidrug-resistant bacteria. Bugworks is currently conducting a First-in-Human (Phase 1) study in Adelaide, Australia, to determine the safety and tolerability of BWC0977, a novel antibiotic compound. It is aimed at treating patients with serious bacterial infections in both critical care and community settings. The Phase 1 study is being supported by CARB-X, a global non-profit partnership accelerating antibacterial products to address drug-resistant bacteria. GARDP is providing support for a cardiac safety study embedded in the ongoing Phase 1 study that will provide a robust assessment of the cardiovascular risk of the compound. The study will provide a more precise indicator for the molecule’s propensity to cause arrhythmia (an irregular heartbeat), which is a side effect of some classes of antibiotics. This will help with decision-making and acceleration of clinical development of this compound. The support of the cardiac safety study follows a memorandum of understanding signed by GARDP and Bugworks in August 2020 to accelerate the development and availability of antibiotic treatments. Bugworks has joined the Australian AMR Network (AAMRNet), consolidating the presence of both GARDP and Bugworks in the Australian AMR research ecosystem. ]]> <![CDATA[Meddo Health expands footprint to tier II and III cities]]> https://biospectrumindia.com/news/95/21396/meddo-health-expands-footprint-to-tier-ii-and-iii-cities.html https://biospectrumindia.com/news/95/21396/meddo-health-expands-footprint-to-tier-ii-and-iii-cities.html Wed, 08 Jun 2022 21:15:00 +0530 Meddo Health has recently announced its PAN India expansion plans to tap tier II and III markets with the launch of full-service healthcare centres. As part of the business plan, the company announces its launch in Chandigarh and Jaipur, with plans to further expand its presence in Pune, Ludhiana, Jalandhar, Lucknow and Ahmedabad among other cities by 2023. With their services already live in Jaipur and Chandigarh, Meddo now seeks to expand its footprint from 4000+ doctors and 350+ Full-Service Health centres currently, to 1000+ centres over the next year. ]]> <![CDATA[Boehringer Ingelheim receives ad-interim injunctions against four domestic pharma cos for diabetes drug]]> https://biospectrumindia.com/news/95/21386/boehringer-ingelheim-receives-ad-interim-injunctions-against-four-domestic-pharma-cos-for-diabetes-drug.html https://biospectrumindia.com/news/95/21386/boehringer-ingelheim-receives-ad-interim-injunctions-against-four-domestic-pharma-cos-for-diabetes-drug.html Tue, 07 Jun 2022 17:10:00 +0530 Boehringer Ingelheim has obtained ad-interim injunctions against four domestic pharmaceutical companies that launched generic versions of Boehringer Ingelheim’s patent-protected drug Linagliptin, which is marketed under the brand name, Trajenta.    The recent injunctions restrain the domestic pharma companies from infringing the patent of Linagliptin by advertising, launching, making, using, offering for sale, selling, importing and/or exporting in any form in India either by themselves or through their directors, partners licenses, stockist and distributors, agents etc., jointly and severally until the next date of hearing. Boehringer Ingelheim holds a valid patent for Linagliptin in India until August 2023.    Vani Manja, MD, Boehringer Ingelheim India, said, “The swift and just actions from the High Court over the past nine months have reaffirmed our faith in the Indian legal system in securing the enforcement of patent rights and upholding of patient interests. This also underlines the strength of Boehringer Ingelheim’s patents."   In the last nine months, Boehringer Ingelheim has received the following injunctions against generic pharmaceutical companies for patent infringement of its innovator drugs Jardiance (Empagliflozin) and Trajenta (Linagliptin): · Ad-interim injunction granted against Dr Reddy’s Laboratories for Empagliflozin which was eventually made absolute · Ad-interim injunction granted against MSN Laboratories for Empagliflozin which was eventually made absolute · Ad-interim injunction granted against MacLeods for Linagliptin which eventually was made absolute · Ad-interim injunction granted against Eris Lifesciences for Linagliptin · Ad-interim injunction granted against MSN Laboratories for Linagliptin · Ad-interim injunction granted against Emcure Pharmaceuticals for Linagliptin · Ad-interim injunction granted against Optimus Pharma for Linagliptin   ]]> <![CDATA[P&G Health promotes sustainable pharmacy waste segregation and management]]> https://biospectrumindia.com/news/95/21378/pg-health-promotes-sustainable-pharmacy-waste-segregation-and-management.html https://biospectrumindia.com/news/95/21378/pg-health-promotes-sustainable-pharmacy-waste-segregation-and-management.html Mon, 06 Jun 2022 17:15:00 +0530 P&G Health has reinforced its commitment to sustainable waste management through its new partnership with the Lakshya and Recycle India Foundation for sustainable pharmacy waste segregation and management project as part of its corporate social responsibility (CSR) programme ‘SEHAT’.   The initiative aims to promote sustainable healthcare practices through an on-ground awareness campaign for pharmacy owners and their staff on appropriate methods of segregating waste materials such as plastic, paper, glass, and biomedical trash including unused or expired medications and supplies, syringes, masks, and disinfectants. When not disposed of properly, these substances can pose a threat to human and animal life.   During the pilot programme, pharmacies will collect the waste materials generated at their respective establishments and segregate them in designated colour-coded dustbins. This material will then be collected periodically and recycled by Recycle India Foundation. Material that cannot be recycled will be disposed of responsibly. ]]> <![CDATA[CORBEVAX bags DCGI nod as heterologous COVID-19 booster dose]]> https://biospectrumindia.com/news/95/21366/corbevax-bags-dcgi-nod-as-heterologous-covid-19-booster-dose.html https://biospectrumindia.com/news/95/21366/corbevax-bags-dcgi-nod-as-heterologous-covid-19-booster-dose.html Sat, 04 Jun 2022 16:50:00 +0530 Hyderabad-based Biological E (BE) has announced that its CORBEVAX COVID-19 vaccine has been approved by the Drug Controller General of India (DCGI) as a heterologous COVID-19 booster dose to individuals aged 18 years and above after six months of administration of primary vaccination (two doses) of COVAXIN or COVISHIELD vaccines for restricted use in an emergency. BE’s CORBEVAX is the first such vaccine in India to be approved as a heterologous COVID-19 booster.   Recently, BE has furnished its clinical trials data to the DCGI who after a detailed evaluation and deliberations with the Subject Experts Committee, granted their approval for administering the CORBEVAX vaccine as a heterologous booster dose to people who have already taken two doses of either COVISHIELD or COVAXIN. BE's clinical trial data showed that the CORBEVAX booster dose provided significant enhancement in immune response and the excellent safety profile required for an effective booster.    BE has conducted a multicentre Phase III placebo-controlled heterologous booster clinical trial in 416 subjects from 18 to 80 years of age who were previously vaccinated with two doses of either COVISHIELD or COVAXIN at least 6 months before the administration of CORBEVAX as a booster dose.   The booster dose of CORBEVAX increased the neutralising antibody titers in the COVISHIELD and COVAXIN groups significantly when compared to the placebo.    ]]> <![CDATA[Pharmaceutical market set to achieve $130B by 2030 with global outlook: OPPI]]> https://biospectrumindia.com/news/95/21362/pharmaceutical-market-set-to-achieve-130b-by-2030-with-global-outlook-oppi.html https://biospectrumindia.com/news/95/21362/pharmaceutical-market-set-to-achieve-130b-by-2030-with-global-outlook-oppi.html Thu, 02 Jun 2022 00:00:00 +0530 The 8th edition of PharmaLytica Expo opened its doors to industry professionals at the Bombay Exhibition Centre, Mumbai on 1 June. The event is being held from 1-3 June 2022. The annual three-day exhibition provides high-profile business matchmaking and networking opportunities for all industry professionals, including domain stalwarts, pharma leaders, technical heads & plant heads, medical heads & scientists, marketing & strategy leaders, R&D heads and technocrats, engineering & production professionals, purchase & packaging professionals, Regulatory Affairs professionals and others. Amongst over 300 brands showcasing their latest developments and 30 conference speakers, the expo is anticipating over 7000 trade visitors. PharmaLytica Conference 2022 is discussing key topics like Challenges and opportunities in moving towards digitalization, strategies for maintaining a global supply chain in a constrained environment and new analysis methods for the optimization of processes in the laboratory thereby transforming labs into smart technological labs. On the occasion of the 8th edition of PharmaLytica, Yogesh Mudras, Managing Director, Informa Markets, India said, “Today pharma is recognized as a well-entrenched sector for our country’s economy and is anticipated to grow threefold in the decade. While it is expected to be a $65 billion industry by 2024, with weighty contributions toward generics, the pharmaceutical industry is all set to further extend its R&D capabilities and offer cutting-edge products in a post-pandemic world.” Speaking at the inauguration, KG Ananthakrishnan, Director General, Organisation of Pharmaceutical Producers of India (OPPI) said, “The pharmaceutical market is set to grow from its current levels of $50 billion to $130 billion by 2030 growing at a CAGR of 12.3%. This target can be achieved by having a global outlook looking at Asian geographies along with existing completive advantage in various industries, favorable factors of production, conducive business environment, and incentivized government policies."       ]]> <![CDATA[BDR Pharma partners with Varenyam Healthcare to revolutionise Anaesthesia practices in India]]> https://biospectrumindia.com/news/95/21348/bdr-pharma-partners-with-varenyam-healthcare-to-revolutionise-anaesthesia-practices-in-india.html https://biospectrumindia.com/news/95/21348/bdr-pharma-partners-with-varenyam-healthcare-to-revolutionise-anaesthesia-practices-in-india.html Tue, 31 May 2022 00:00:00 +0530 Mumbai-based BDR Pharmaceuticals and Varenyam Healthcare have announced the launch of Sugmadex, bringing to India a first of its kind drug in over 10 years with novel γ-cyclodextrin neuromuscular block (NMB) reversal properties. Sugmadex (Sugammadex 100mg/ml) is a pioneer in Anaesthesia drugs offering safe, rapid and complete reversal of shallow, moderate and deep neuromuscular block (NMB), resulting in the removal of anaesthesia effect on the  body. Currently available reversal agents cannot reverse profound NMB & quite often result in postoperative respiratory complications. The clinical use of Sugmadex is a breakthrough that promises to eliminate many of the shortcomings in current anaesthetic practice. Sugmadex is available as 2 ml & 5 ml single-dose vials.  Commenting on the launch, Raheel Shah, Director Business Development on behalf of BDR Pharmaceuticals said, “The results collated from the Indian trials on patients promise to be advantageous for the users lacking any side effects. Sugmadex is set to be the game changer in the segment of reversal agents in the modern day surgery. This product is testament to our objective of bringing innovation with the introduction of Novel drugs which were not present in the domestic market previously.” ]]> <![CDATA[JB Chemicals and Pharma announces new brand identity]]> https://biospectrumindia.com/news/95/21333/jb-chemicals-and-pharma-announces-new-brand-identity.html https://biospectrumindia.com/news/95/21333/jb-chemicals-and-pharma-announces-new-brand-identity.html Sun, 29 May 2022 20:20:00 +0530 JB Chemicals & Pharmaceuticals has emerged in a new avatar as JB, retaining its core value of being ‘Good people for good health’. The company announced its new identity during a recently held conference in Mumbai.   In the financial year 2021-22, the company has recorded revenue of Rs 2424 crores as compared to Rs 2043 crores in FY 2020-21, registering a growth of 19 per cent. The sales growth for the last quarter was 18 per cent and domestic formulations continued their market-beating performance, recording a growth of 30 per cent.   JB’s international business witnessed double-digit growth across segments with a growth rate of 9 per cent YoY. A strong surge driven by the contract manufacturing business in South Africa and APIs has been recorded. ]]> <![CDATA[Italy-based biopharma co A Menarini launches Solar D Sunscreen]]> https://biospectrumindia.com/news/95/21330/italy-based-biopharma-co-a-menarini-launches-solar-d-sunscreen.html https://biospectrumindia.com/news/95/21330/italy-based-biopharma-co-a-menarini-launches-solar-d-sunscreen.html Sun, 29 May 2022 19:50:00 +0530 A Menarini India, part of the Menarini Group, Italian-based biopharmaceutical company, has launched ‘Solar D’ sunscreen – a breakthrough innovation in dermatology in over 70 years.   The revolutionary SPF 50, water and sweat-resistant sunscreen, uses a unique UV activated vitamin D technology that allows your body to naturally produce Vitamin D while protecting your skin from burning, ageing, and tanning.   The groundbreaking SPF technology is specifically designed and formulated to prevent sunburn or sun damage while allowing the passage of sufficient UVB light that our bodies use to naturally produce vitamin D. It uses compounds with differing filter compositions that enable and maximises vitamin D production while maintaining its broad-spectrum sun protection.   Non-oily, PA++++ protection grade, and easy to blend, Solar D SPF 50 is essential for all outdoor warriors, and people with sensitive skin including children over six months. Perfect for those who bike, hike, or enjoy water sports, Solar D SPF 50 is water-resistant and sweat resistant for up to 120 minutes, allowing them to get maximum work. The sunscreen is free of oil and fragrances. ]]> <![CDATA[B Medical Systems installs solar direct drive vaccine refrigerators in Meghalaya]]> https://biospectrumindia.com/news/95/21329/b-medical-systems-installs-solar-direct-drive-vaccine-refrigerators-in-meghalaya.html https://biospectrumindia.com/news/95/21329/b-medical-systems-installs-solar-direct-drive-vaccine-refrigerators-in-meghalaya.html Sun, 29 May 2022 19:40:00 +0530 Luxembourg-based medical cold chain solutions provider B Medical Systems has announced the installation of solar direct drive vaccine refrigerators at the public health centres and sub-centres in Meghalaya.    The Grand Duchy of Luxembourg to India, Peggy Frantzen visited the Mawlynrei centre to commission the device. She presented the first made in India vaccine carrier to the PHC Sub Centre.     The solar direct drive refrigerators manufactured by B Medical Systems are powered by solar energy and ensure the safe storage of vaccines even in locations with unreliable electricity. The company is in the process of installing several units across the country.    Talking about the new project, Jesal Doshi, CEO of B Medical Systems India said, “There is a difference between developing the vaccine and administering it effectively and sustainably. This is where solar direct drive vaccine refrigerators play a crucial role. These units store vaccines reliably even during periods of power outages but also rely on green and sustainable solar power.  Green cold chains are the future and we are excited to bring this product and technology to India.’’ ]]> <![CDATA[Alniche Lifesciences unveils new office in Delhi]]> https://biospectrumindia.com/news/95/21328/alniche-lifesciences-unveils-new-office-in-delhi.html https://biospectrumindia.com/news/95/21328/alniche-lifesciences-unveils-new-office-in-delhi.html Fri, 27 May 2022 18:25:00 +0530 Alniche has unveiled its new office in Delhi. The new office space doubles the office footprint and supports the company’s growth strategy. The new workplace has been meticulously designed in the modern state-of-the-art and is equipped with the latest amenities.    Says Girish Arora, Founder & MD - Alniche Lifesciences, “This initiative aligns with Alniche’s business growth strategy and provides scope to accommodate an additional workforce to manage new projects in the future." ]]> <![CDATA[Torrent Pharma acquires 4 brands from Dr Reddy’s Laboratories]]> https://biospectrumindia.com/news/95/21324/torrent-pharma-acquires-4-brands-from-dr-reddys-laboratories.html https://biospectrumindia.com/news/95/21324/torrent-pharma-acquires-4-brands-from-dr-reddys-laboratories.html Thu, 26 May 2022 21:45:00 +0530 Ahmedabad-based Torrent Pharmaceuticals has entered into an agreement with Dr Reddy's Laboratories to acquire four of its brands Styptovit-E, Finast, Finast-T and Dynapress.Styptovit-E, a gynaecology product with estimated market size of ~Rs 500 crores (AIOCD data set), will further strengthen Torrent’s presence in the therapy. The acquisition of Finast; Finast-T, and Dynapress, which are used in the treatment of Benign Prostatic Hyperplasia (BPH), will aid in Torrent's presence in the Urology therapy.As per the terms of the definitive agreement, Torrent Pharma will take over the manufacturing, marketing and distribution of these brands in India. The complete integration and transition of the brands are expected to be completed by June 2022. ]]> <![CDATA[DFE Pharma opens CoE in Hyd to provide fast-track formulation services]]> https://biospectrumindia.com/news/95/21323/dfe-pharma-opens-coe-in-hyd-to-provide-fast-track-formulation-services.html https://biospectrumindia.com/news/95/21323/dfe-pharma-opens-coe-in-hyd-to-provide-fast-track-formulation-services.html Thu, 26 May 2022 19:25:00 +0530 German firm DFE Pharma has launched its new Centre of Excellence (CoE) 'Closer to the Formulator' (C2F) in Hyderabad. The C2F centre is based in Genome Valley, a hub of major Indian and global biopharmaceutical companies and renowned research organisations. C2F helps pharma companies to shorten the time from a concept to a finished commercial product through expertise in all phases of pharma development.    The services offered by this new state-of-the-art facility are mainly focused on oral solid dosage forms, comprising all types of pre-registration work including development, scale-up, and technology transfer. Formulation support includes specialised dosage forms such as orally disintegrating, effervescent, chewable, and sublingual tablets, minitablets, etc. C2F capabilities also support efficiency projects such as conversion from wet granulation to direct compression.    The centre works with active pharmaceutical ingredients (APIs) and can utilise innovative concepts with model APIs. The equipment covers an instrumented tablet press, an automated capsule filling machine, a tablet coater, a blister packaging machine, stability chambers, and state-of-the-art analytical equipment. The C2F offering can provide pharmaceutical companies with multiple advantages such as significantly lowering the number of development cycles, for example, and reducing formulation costs when launching a medicine.      ]]> <![CDATA[Medtronic, DaVita announce kidney health tech company]]> https://biospectrumindia.com/news/95/21322/medtronic-davita-announce-kidney-health-tech-company.html https://biospectrumindia.com/news/95/21322/medtronic-davita-announce-kidney-health-tech-company.html Thu, 26 May 2022 19:15:00 +0530 Medtronic and DaVita announced the intent to form a new, independent kidney care-focussed medical device company NewCo to enhance the patient treatment experience and improve overall outcomes.   NewCo will be uniquely positioned to advance the development of differentiated therapies for patients with kidney failure. The company will focus on developing a broad suite of novel kidney care products and solutions, including future home-based products, to make different dialysis treatments more accessible to patients.   Under the terms, NewCo will be co-owned by Medtronic and DaVita, each with equal equity stakes, and led by an independent management team. Medtronic will contribute its Renal Care Solutions (RCS) business including the current product portfolio (renal access, acute therapies, and chronic therapies), product pipeline, and global manufacturing R&D teams and facilities. No other Medtronic products or portfolios, including those in the AV access portfolio in the Peripheral Vascular Health business, are included. Both companies will provide an initial investment to fund NewCo and future certain operating capital.   NewCo, which will be renamed and rebranded at close, will operate as an independent company governed by a six-person board of directors composed of two directors each from Medtronic and DaVita, and two independent directors.   ]]> <![CDATA[Thyrocare opens regional processing lab in Nagpur]]> https://biospectrumindia.com/news/95/21313/thyrocare-opens-regional-processing-lab-in-nagpur.html https://biospectrumindia.com/news/95/21313/thyrocare-opens-regional-processing-lab-in-nagpur.html Wed, 25 May 2022 17:20:00 +0530 Thyrocare has launched its first Regional Processing Lab (RPL) in Nagpur which is the 17th lab in India on the occasion of World Thyroid Day. The centre is located at Mytri Willows, Sir Bezonji Mehta Road, Nagpur. The RPL will serve Nagpur and the surrounding areas in the Vidarbha region.  The lab with an area of 3400 sq feet has advanced 24/7 unidirectional sample processing systems and automatic treatment plants with a capacity of processing 3000 samples in a day.  Sachin Salvi, CFO, Thyrocare Technologies, "The new lab will provide a comprehensive range of diagnostics services to patients, doctors and hospitals in Nagpur and the Vidarbha region. The new RPL will augment our existing network of a Centralised Processing Laboratory in Navi Mumbai for complex tests, three zonal processing laboratories in Bengaluru, Delhi and Kolkata for advanced tests and 16 Regional Processing Laboratories pan India, for other routine tests.” ]]> <![CDATA[Akums Drugs bags DCGI, CDSCO approval for Bempedoic acid tabs]]> https://biospectrumindia.com/news/95/21310/akums-drugs-bags-dcgi-cdsco-approval-for-bempedoic-acid-tabs.html https://biospectrumindia.com/news/95/21310/akums-drugs-bags-dcgi-cdsco-approval-for-bempedoic-acid-tabs.html Wed, 25 May 2022 12:15:00 +0530 Akums Drugs & Pharmaceuticals has acquired the license to manufacture and commercialise the drug named Bempedoic acid frm DCGI and CDSCO. Bempedoic acid is a new class of drug for treating high LDL-cholesterol conditions that are indicative of cardiovascular diseases.    Sandeep Jain, Founder, Promoter and Director, Akums Drugs & Pharmaceuticals, says, “Our research & development teams are working on various combinations of Bempedoic plus other molecules and soon these innovative products will also be introduced in India”.   Sanjeev Jain, Founder, Promoter and Director, Akums Drugs & Pharmaceuticals, says, “This therapy is an important addition to the management of dyslipidaemia through effective disease management. We will capture significant market share and be the pioneers in introducing the complete range of Bempedoic acid.”   ]]> <![CDATA[Cadila Pharma launches cholesterol drug Belmore]]> https://biospectrumindia.com/news/95/21306/cadila-pharma-launches-cholesterol-drug-belmore.html https://biospectrumindia.com/news/95/21306/cadila-pharma-launches-cholesterol-drug-belmore.html Wed, 25 May 2022 10:20:00 +0530 Ahmedabad-based Cadila Pharmaceuticals has launched a novel drug for the treatment of high LDL cholesterol for the first time in India.   To be sold under the brand name Belmore, Bempedoic acid is a one-of-its-kind drug for the treatment of high LDL (low-density lipoprotein) cholesterol, also known as bad cholesterol.   “Belmore (bempedoic acid) provides additional benefits to patients, and all pre-launch studies have established this advantage. Belmore is one more addition to our fast-growing portfolio of indigenous innovations. We are committed to continuing our journey of making affordable drugs available to everyone,” said Jawed Zia, CEO , Domestic Prescription Business, Cadila Pharmaceuticals.   ]]> <![CDATA[Piramal Pharma Solutions upgrades oral solid dose capabilities at Pithampur site]]> https://biospectrumindia.com/news/95/21309/piramal-pharma-solutions-upgrades-oral-solid-dose-capabilities-at-pithampur-site.html https://biospectrumindia.com/news/95/21309/piramal-pharma-solutions-upgrades-oral-solid-dose-capabilities-at-pithampur-site.html Wed, 25 May 2022 00:00:00 +0530 Piramal Pharma Limited's Pharma Solutions business, a leading Contract Development and Manufacturing Organization (CDMO), has announced a new production block has come online at the company's drug product site in Pithampur, in the state of Madhya Pradesh. The new production area, known as V Block, can handle batch sizes of 150 to 600 kilograms, augmenting the site's capacity to produce oral solid dosage form drug product. With the addition of V Block, the Pithampur site's total production capacity increases from 3 billion doses to 4.5 billion doses. V Block includes aqueous and non-aqueous wet granulation (high shear, top spray and bottom spray); direct, mono, and bilayer compression; aqueous and non-aqueous coating; and bottle packaging technologies. Aggregation capabilities related to US FDA e-pedigree and track and trace requirements are planned for V Block, as is the addition of dry granulation capabilities (roller compaction). Like the other four production blocks on site, V Block has dedicated personnel and material entry with biometric access control for the block and the operating cubicles within it, as well as dedicated air handling unit for each cubicle. The Pithampur site employs approximately 600 workers and supplies drug product to biotech, small pharma, large pharma, and large generics customers around the world, supporting their needs for both on-patent and generic drug projects. ]]> <![CDATA[HNZ Lifesciences unveils brand AMIO WELLNESS]]> https://biospectrumindia.com/news/95/21304/hnz-lifesciences-unveils-brand-amio-wellness.html https://biospectrumindia.com/news/95/21304/hnz-lifesciences-unveils-brand-amio-wellness.html Tue, 24 May 2022 13:15:00 +0530 HNZ Lifesciences announced the launch of its new brand AMIO WELLNESS. The brand products are in the categories of intimate wellness. skin care and hair care.   Karan Arora, Founder & MD, HNZ Lifesciences said, “We started on a mission to break the stereotype and turn intimacy into an accepted subject of day-to-day conversations. We aim to educate our community that it is equally important to focus on intimate and sexual wellbeing and not settle for disappointing and unpleasant experiences. For us, beauty and wellness are a result of self-love and self-care."   ]]> <![CDATA[Glenmark launches Whatsapp-based chatbot for fungal infections ]]> https://biospectrumindia.com/news/95/21302/glenmark-launches-whatsapp-based-chatbot-for-fungal-infections-.html https://biospectrumindia.com/news/95/21302/glenmark-launches-whatsapp-based-chatbot-for-fungal-infections-.html Tue, 24 May 2022 11:40:00 +0530 Glenmark Pharmaceuticals has developed a digital patient education tool 'Hello Skin' in collaboration with the IADVL (Indian Association of Dermatologists, Venereologists and Leprologists), to help patients suffering from Dermatophytosis (Ring Worm or Tinea) in India, to adhere to the recommended treatment duration.Hello Skin helps patients not only improve adherence to optical/systemic recommended therapy with daily pill reminders, but also in creating disease awareness and provides skincare tips to patients suffering from Ring Worm. This platform is patient-friendly and will be available in six different regional languages including Hindi and English, enabling better patient compliance with the technology. ]]> <![CDATA[Exergen Corp launches TAT-2000 temporal artery thermometer]]> https://biospectrumindia.com/news/95/21298/exergen-corp-launches-tat-2000-temporal-artery-thermometer.html https://biospectrumindia.com/news/95/21298/exergen-corp-launches-tat-2000-temporal-artery-thermometer.html Mon, 23 May 2022 15:20:00 +0530 Exergen Corporation has launched the made for India, TAT-2000 Temporal Artery Thermometer at the recently held Medical Fair in Mumbai. Exergen creates non-invasive temperature measurement devices providing lower cost, higher accuracy, no invasiveness, and greater reliability combined with phenomenal ease of use.Ellen Minkels, Senior Director of International Business Development said, “ We are confident that our range of innovative products, including the TAT-2000 which has been specifically created for the Indian market will disrupt the marketplace, and will be adopted by leading healthcare institutions, hospitals, clinics and elderly homes in the next two to three years.”The TAT-2000 has been specially created for the Indian market with its focus on procurement, being highly attractive in terms of cost of ownership, performance, and functionality, with a seven-year warranty which is almost considered a lifetime warranty. ]]> <![CDATA[BD Life Sciences organises roadshows on clinical flow cytometry ]]> https://biospectrumindia.com/news/95/21286/bd-life-sciences-organises-roadshows-on-clinical-flow-cytometry-.html https://biospectrumindia.com/news/95/21286/bd-life-sciences-organises-roadshows-on-clinical-flow-cytometry-.html Fri, 20 May 2022 16:40:00 +0530 BD Life Sciences-Biosciences, a segment of BD (Becton, Dickinson and Company) recently organised the ‘Advances in Clinical Flow Cytometry’ (ACFC) multi-city roadshow for clinicians and physicians. Organised in Bengaluru, Dhaka, Lucknow and Mumbai, each of the ACFC events enabled discussions by experts from the clinical fraternity on critical aspects of clinical diagnostics including standardisation, performance, accreditation, automation and collaboration.   Key highlights of the discussions were:   Case studies on Leukemia and Lymphoma as well as Minimal Residual Disease amongst others. Deliberation of standard operating protocols, accuracy and standardisation of flow cytometry assays.  Importance of Quality and standardisation of assays in clinical flow cytometry.           ]]> <![CDATA[Generic Aadhaar plans to open 300+ franchisee stores in Karnataka]]> https://biospectrumindia.com/news/95/21284/generic-aadhaar-plans-to-open-300-franchisee-stores-in-karnataka.html https://biospectrumindia.com/news/95/21284/generic-aadhaar-plans-to-open-300-franchisee-stores-in-karnataka.html Fri, 20 May 2022 16:05:00 +0530 Generic Aadhaar has set up a strong franchise network in Karnataka, Andhra Pradesh, Kerala, and Tamil Nadu. Currently, it has a presence in 150+ cities and plans to open 300+ franchisee stores in Karnataka. The firm currently has more than 30 franchises across Karnataka's districts of Vijayapura, Kalaburagi, Bagalkot, Dharwad, Belgaum, Davanagere, Shivamogga, Chitradurga, Bengaluru Rural, Bengaluru Urban, Kolar, Mysuru, and many more.Currently, there are Generic Aadhaar franchise owners in every state, including big cities such as Mumbai, Delhi, Bengaluru, Hyderabad, etc., and remote villages like Birbhum Chidambaram, Mhow, etc. Arjun Deshpande, Founder & CEO, Generic Aadhaar, said, “We intend to reach every nook and corner of the country with plans to open 15000+ stores in years to come.” ]]> <![CDATA[Piramal Pharma's API plant in Canada completes initial production run]]> https://biospectrumindia.com/news/95/21280/piramal-pharmas-api-plant-in-canada-completes-initial-production-run.html https://biospectrumindia.com/news/95/21280/piramal-pharmas-api-plant-in-canada-completes-initial-production-run.html Fri, 20 May 2022 11:35:00 +0530 Piramal Pharma's Pharma Solutions business has announced that a new active pharmaceutical ingredient (API) plant at the company's site in Aurora, Ontario, has come online and successfully completed its initial production runs.   The new plant, built as part of a CAD $30 million capital investment in the Aurora site, features more than ten thousand square feet of new manufacturing space and includes two new reactor suites with additional filtration and drying capabilities. It will support ongoing customer demand for Piramal Pharma Solutions' expertise in APIs and enhances and expands the company's ability to produce clinical to commercial scale APIs including highly potent APIs requiring an Occupational Exposure Limit (OEL) of 1mcg/m3.   Since coming online, the plant has successfully implemented programmes for clients that include process validation campaign, a registration campaign for clinical re-supply, and an engineering campaign. There is strong customer demand for the new plant's capacity, with a pipeline of clinical and commercial scale projects planned for the future. ]]> <![CDATA[Biocon Biologics, Viatris launch oncology biosimilar Abevmy in Canada]]> https://biospectrumindia.com/news/95/21278/biocon-biologics-viatris-launch-oncology-biosimilar-abevmy-in-canada.html https://biospectrumindia.com/news/95/21278/biocon-biologics-viatris-launch-oncology-biosimilar-abevmy-in-canada.html Thu, 19 May 2022 18:15:00 +0530 Biocon Biologics and Viatris announced that Abevmy (bBevacizumab) is now available in Canada. Abevmy, co-developed by Biocon Biologics and Viatris, is a biosimilar to Roche’s Avastin (Bevacizumab) and has been approved by Health Canada across four oncology indications.Abevmy follows the launch of our two oncology biosimilars in Canada, Ogivri (bTrastuzumab) in 2019 – the first Trastuzumab approved in the country – and Fulphila (bPegfilgrastim), which was launched in 2020. In addition to the therapeutic area of oncology, Viatris Canada launched Hulio (bAdalimumab) in February 2021 for chronic inflammatory conditions.Abevmy is authorised for use in the following indications: Metastatic Colorectal Cancer (mCRC) Locally Advanced, Metastatic or Recurrent Non-Small Cell Lung Cancer (NSCLC) Platinum-Resistant Recurrent Epithelial Ovarian, Fallopian Tube and Primary Peritoneal Cancer Malignant Glioma (WHO Grade IV) - Glioblastoma The two formats approved and now available in Canada are 100 mg/4 mL single-use vial and 400 mg/16 mL single-use vial. ]]> <![CDATA[Leads Connect in MoU with ISF College of Pharmacy, Moga]]> https://biospectrumindia.com/news/95/21277/leads-connect-in-mou-with-isf-college-of-pharmacy-moga.html https://biospectrumindia.com/news/95/21277/leads-connect-in-mou-with-isf-college-of-pharmacy-moga.html Thu, 19 May 2022 18:05:00 +0530 Noida-based agri-tech company, Leads Connect Services has signed a Memorandum of Understanding (MoU) with ISF College of Pharmacy, Moga, Punjab for the development of an Intelligent Health Analytics platform. The collaboration between Leads Connect and ISF College of Pharmacy aims to develop an intelligent health analytics platform for monitoring, mitigating and forecasting biological disasters. The robust platform will help in improving the quality of health services. It further may be useful in identifying the aspects of health infrastructures where improvement is needed to make it more resilient and robust.    Leads Connect is already working in collaboration with national and international institutions and organizations such as Birla Institute of Technology (BIT), Mesra, Ranchi and AIR Institute- DeepTech Lab, Spain for performing research and development activities. The company has also taken analytical initiatives such as Northeast India and Jharkhand initiatives on investigating climate change and environmental sustainability. ]]> <![CDATA[Boehringer Ingelheim’s drug Jardiance bags CDSCO approval]]> https://biospectrumindia.com/news/95/21275/boehringer-ingelheims-drug-jardiance-bags-cdsco-approval.html https://biospectrumindia.com/news/95/21275/boehringer-ingelheims-drug-jardiance-bags-cdsco-approval.html Thu, 19 May 2022 17:10:00 +0530 Boehringer Ingelheim has received approval from the Central Drugs Standard Control Organisation (CDSCO) to market its innovator drug Jardiance (empagliflozin) in India, for the treatment of heart failure with preserved ejection fraction (HFpEF).   With this approval, Jardiance is now the first and only clinically approved therapy to reduce the risk of cardiovascular death plus hospitalisation for heart failure in adults with heart failure, across the full spectrum of ejection fraction.   The new indication approval applies to eligible patients with HFpEF, regardless of their type-2 diabetes status, and is an addition to the previously approved indications for glycemia control in type-2 diabetes, as well as for reducing the risk of cardiovascular death plus hospitalization for adults with heart failure with reduced ejection fraction (HFrEF). ]]> <![CDATA[Sun Pharma offers Brillo, a first-in-class oral lipid-lowering drug in India ]]> https://biospectrumindia.com/news/95/21269/sun-pharma-offers-brillo-a-first-in-class-oral-lipid-lowering-drug-in-india-.html https://biospectrumindia.com/news/95/21269/sun-pharma-offers-brillo-a-first-in-class-oral-lipid-lowering-drug-in-india-.html Thu, 19 May 2022 00:00:00 +0530 Sun Pharmaceutical Industries has announced that one of its wholly-owned subsidiaries plans to launch a first-in-class oral drug, Bempedoic Acid, in India for reducing low-density lipoprotein (LDL) cholesterol. The company will launch the drug under the brand name “Brillo”. It is a first-in-class drug which has a new mechanism of action compared to the currently available lipid-lowering agents. It is indicated for people who have an inherited genetic disorder that causes high cholesterol levels or established heart disease where cholesterol levels remain high, despite lifestyle changes and the use of maximum tolerated dose of statins. Kirti Ganorkar, CEO – India Business, Sun Pharma said, “Sun Pharma is the leader in the cardiovascular segment and a pioneer in lipid-lowering therapy in India. In line with our commitment to introducing novel products, we are launching this first-in-class oral drug, Brillo®. It is a novel treatment option that will help manage high LDL cholesterol in patients with heart diseases, a condition which is growing at an alarming rate.” One in four deaths in India is now because of heart diseases, with ischemic heart disease and stroke responsible for >80% of this burden. These diseases tend to affect patients in the most productive years of their lives and result in catastrophic social and economic consequences. ]]> <![CDATA[Adroit Biomed launches Fortisil range of smart skincare products]]> https://biospectrumindia.com/news/95/21262/adroit-biomed-launches-fortisil-range-of-smart-skincare-products.html https://biospectrumindia.com/news/95/21262/adroit-biomed-launches-fortisil-range-of-smart-skincare-products.html Wed, 18 May 2022 10:20:00 +0530 Mumbai-based Adroit BioMed has launched Fortisil range of products which brings to India patented formulations that offers smart skincare with a deep focus on protection, repair and rejuvenation of skin, hair and nails from within.   Sushant Raorane, Co-founder and Director, Adroit Biomed said, "With our Fortisil range of products, we aim to offer solutions that protect skin, hair & nails from harmful UV rays and HEV light, repair skin with intrinsic production of proteins and accelerates skin renewal, thereby revolutionising skincare segment."   The newly launched Fortisil range of products are available in capsules and three varieties of smart sunscreens. These are Fortisil OSA capsules: Fortisil Smart Sunscreens; Fortisil SPF 50+ and PA+++ rated sunscreen and Foritisil SPF 50+ Tinted sunscreen and Fortisil SPF 30+ sunscreen.   The Indian derma market is flooded with a large variety of sunscreen products which is indicative of the rising demand. However consumer demand has now shifted towards more superior formulations that ensure complete skin protection, including a marked shift from anti-aging to positive aging and graceful aging. Adroit aims to address this need with its Fortisil range of patented formulation. ]]> <![CDATA[Dr Agarwals Eye Hospitals acquires five eye hospitals in Tricity region]]> https://biospectrumindia.com/news/95/21260/dr-agarwals-eye-hospitals-acquires-five-eye-hospitals-in-tricity-region.html https://biospectrumindia.com/news/95/21260/dr-agarwals-eye-hospitals-acquires-five-eye-hospitals-in-tricity-region.html Tue, 17 May 2022 18:35:00 +0530 Chennai-based Dr Agarwals Eye Hospitals has established its presence in the Tricity region by acquiring five eye hospitals, including two in Chandigarh, two in Panchkula, and one in Mohali. These include units of Mirchia’s Laser Eye Clinic, JP Eye Hospital and Dr Monica's Eye Clinic. The acquisition has expanded the presence of Dr Agarwals Eye Hospitals to Punjab, Haryana, and Chandigarh, taking the total tally of its existing centres across the country to 110.    Dr Adil Agarwal, CEO, Dr Agarwals Eye Hospitals said, “We have aggressive growth plans, especially for North India and states like Punjab and Haryana. We have added more than 60 units to our network in the past 5 years alone, and plan to double our current network of hospitals to more than 200 in the next three to four years.”    The company has been on a growth spree across the country through acquisitions and establishing new facilities. To fuel its expansion and deploy the latest technologies, the company raised over Rs 1,000 crore recently from TPG Growth and Temasek in the country’s largest fund raise in the eye care space.  ]]> <![CDATA[HempStreet in strategic partnership with Israeli Femtech Co Gynica]]> https://biospectrumindia.com/news/95/21257/hempstreet-in-strategic-partnership-with-israeli-femtech-co-gynica.html https://biospectrumindia.com/news/95/21257/hempstreet-in-strategic-partnership-with-israeli-femtech-co-gynica.html Tue, 17 May 2022 16:15:00 +0530 HempStreet has partnered with Gynica, an R&D company based out of Israel focused on changing the culture of gynaecological treatment through clinically proven, cannabinoid-based solutions. The partnership will benefit the companies to strengthen their R&D capabilities and develop clinically-proven, robust phytopharmaceutical products to improve menstrual health and tackle other mass ailments.   Both the companies will co-develop medical products for the Indian market to tackle ailments specifically related to women’s health.   ]]> <![CDATA[Trinity Life Sciences opens office in Gurugram]]> https://biospectrumindia.com/news/95/21255/trinity-life-sciences-opens-office-in-gurugram.html https://biospectrumindia.com/news/95/21255/trinity-life-sciences-opens-office-in-gurugram.html Tue, 17 May 2022 11:55:00 +0530 Trinity Life Sciences, a leader in global life sciences commercialisation solutions, has opened its next-generation office space in Gurugram. The opening of the new office is part of Trinity’s ongoing commitment to support development and innovation in the Asia-Pacific region.    The office boasts sleek contemporary design and state-of-the-art technology to support continued growth and global collaboration. Meeting rooms are equipped with one-touch video conferencing technology, and large agile breakout spaces are installed for employees to enjoy meeting together both informally and for business. ]]> <![CDATA[Takeda unveils advanced prophylaxis treatment for haemophilia patients]]> https://biospectrumindia.com/news/95/21247/takeda-unveils-advanced-prophylaxis-treatment-for-haemophilia-patients.html https://biospectrumindia.com/news/95/21247/takeda-unveils-advanced-prophylaxis-treatment-for-haemophilia-patients.html Mon, 16 May 2022 12:50:00 +0530 Takeda Pharmaceutical Company has launched Adynovate, an innovative extended half-life recombinant Factor VIII (rFVIII) treatment, using established technology (controlled PEGylation), for haemophilia A patients in India.    Adynovate in combination with MYPKFIT, the first and only FDA approved application offers a personalised and interactive prophylaxis treatment option that enables both healthcare professionals (HCPs) and patients in real-time to monitor factor VIII levels. Alerts are sent to patients on prophylaxis when their estimated factor VIII levels are low and remind them when their infusions are due, thereby providing excellent prophylactic coverage.   Administered in three steps with BAXJECT III system, Adynovate eliminates the need to disinfect the vial, as vials are already assembled in the system housing. It can be stored at room temperature not to exceed 30°C (86°F) for a period of up to three months not to exceed the expiration date thereby easing the handling and storing process. ]]> <![CDATA[Biological E reduces CORBEVAX price to Rs 250 per dose]]> https://biospectrumindia.com/news/95/21246/biological-e-reduces-corbevax-price-to-rs-250-per-dose.html https://biospectrumindia.com/news/95/21246/biological-e-reduces-corbevax-price-to-rs-250-per-dose.html Mon, 16 May 2022 11:55:00 +0530 Hyderabad-based Biological E (BE) has reduced the price of its COVID-19 Vaccine CORBEVAX, from Rs 840 to Rs 250 a dose inclusive of GST, for private COVID-19 vaccination centres. For the end-user, the price would be Rs 400 a dose, including taxes and administration charges.    The company aims to make the vaccines more affordable and help increase the reach to protect the maximum number of children against the virus.   The decision comes within weeks of Biological E receiving Emergency Use Authorization (EUA) for children between 5 and 12 years of age. The previous private market price for the vaccine was Rs 990 a dose including taxes and vaccine administration charges.    ]]> <![CDATA[Zeon Lifesciences plans India expansion]]> https://biospectrumindia.com/news/95/21242/zeon-lifesciences-plans-india-expansion.html https://biospectrumindia.com/news/95/21242/zeon-lifesciences-plans-india-expansion.html Mon, 16 May 2022 11:25:00 +0530 Noida-based Zeon Lifesciences having its facility in Paonta Sahib in Himachal Pradesh is looking for expansion plans and is currently in the process to look for a suitable location for the same. The company is in talks with US-based clients.The company also aims to establish collaboration for academic interaction and advancement of research in specified fields and to conduct research along with sharing facilities. The company has recently signed an MoU with University of Petroleum and Energy Studies (UPES) Dehradun for research related works in nutraceuticals, phytopharmaceuticals and AYUSH. According to Suresh Garg, Founder and MD, Zeon Lifesciences, the company has registered a turnover of Rs 230 crore in 2021-22 and there are expectations of Rs 300-crore turnover in FY 22-23.   Sanjiv Das sanjiv.das@mmactiv.com ]]> <![CDATA[Zydus Lifesciences launches of Bemdac to treat uncontrolled LDL-Cholesterol ]]> https://biospectrumindia.com/news/95/21241/zydus-lifesciences-launches-of-bemdac-to-treat-uncontrolled-ldl-cholesterol-.html https://biospectrumindia.com/news/95/21241/zydus-lifesciences-launches-of-bemdac-to-treat-uncontrolled-ldl-cholesterol-.html Mon, 16 May 2022 00:00:00 +0530 Zydus Lifesciences (formerly known as Cadila Healthcare) has announced the launch of Bemdac (Bempedoic acid), a new class of drug for the first time in India. The oral drug ushers in a new line of treatment for patients suffering from uncontrolled levels of LDL-Cholesterol (LDL-c) despite life-style modifications and the use of maximum tolerated dose of statins, which form the cornerstone of dyslipidemia management. LDL-c is often referred to as bad cholesterol since it gets deposited in the walls of the blood vessels, increasing the chances of health problems like heart attack or stroke. Uncontrolled LDL-c is a major risk factor for developing cardiovascular diseases. Speaking on the development, Dr Sharvil Patel, Managing Director, Zydus Lifesciences said “With Bemdac, we are happy to introduce a first-in-India therapy to address the unmet medical need of people suffering from uncontrolled LDL-c. Bemdac is an important addition to Zydus’ portfolio of medicines for managing dyslipidemia and cholesterol. Our mission is to empower patients with a better quality of life through effective disease management and with Bemdac we have taken a great leap ahead in this endeavour.” ]]> <![CDATA[Serum Institute of India, Symbiosis to set up R&D centre for vaccines, biologicals]]> https://biospectrumindia.com/news/95/21238/serum-institute-of-india-symbiosis-to-set-up-rd-centre-for-vaccines-biologicals.html https://biospectrumindia.com/news/95/21238/serum-institute-of-india-symbiosis-to-set-up-rd-centre-for-vaccines-biologicals.html Fri, 13 May 2022 15:30:00 +0530 Serum Institute of India (SII) and Symbiosis International University (SIU) have signed a Memorandum of Understanding (MoU) in Pune to set up an early research centre for vaccines and biologicals.   The R&D centre will lead the development of new vaccines, technologies, products, and innovations in immunization practices that provide equitable access to life-saving interventions, especially across Low-and middle-income countries (LMIC’s).    SII will help set up an early R&D facility within the Symbiosis campus at Lavale, Pune. The research centre will build and harness commitment to action by identifying opportunities that strengthen, to establish global immunisation agenda in pursuit of universal health coverage.   It will also ensure cross-programme coordination and collaboration, as the facility will be an ecosystem that also has R&D centres for stem cells, nanotechnology, medical image analysis, Applied AI, waste resource management among others.  ]]> <![CDATA[Roche Pharma launches HER-2 positive breast cancer therapy in India]]> https://biospectrumindia.com/news/95/21231/roche-pharma-launches-her-2-positive-breast-cancer-therapy-in-india.html https://biospectrumindia.com/news/95/21231/roche-pharma-launches-her-2-positive-breast-cancer-therapy-in-india.html Thu, 12 May 2022 17:25:00 +0530 Roche Pharma has announced the India launch of PHESGO – the first ever fixed dose formulation in oncology to combine two monoclonal antibodies - Perjeta (pertuzumab) and Herceptin (trastuzumab) with hyaluronidase, administered by subcutaneous injection in combination with intravenous (IV) chemotherapy, for the treatment of early and metastatic HER2-positive breast cancer. This is the first time that Roche has combined two monoclonal antibodies that can be administered by a single SC injection.   PHESGO can be administered as a single injection just under the skin in the thigh and it takes a few minutes compared to hours with IV formulations for each round of treatment, thus reducing chair time for patients by 90 per cent.   PHESGO can help breast cancer patients continue receiving their treatment due to significantly shorter administration times and the convenience of subcutaneous administration, potentially moving the treatment from oncology wards to daycare and OPD settings.  ]]> <![CDATA[Philips expands manufacturing and R&D facility in Pune]]> https://biospectrumindia.com/news/95/21226/philips-expands-manufacturing-and-rd-facility-in-pune.html https://biospectrumindia.com/news/95/21226/philips-expands-manufacturing-and-rd-facility-in-pune.html Thu, 12 May 2022 13:20:00 +0530 Royal Philips has completed the 7200 sq mt expansion in its factory in Chakan, Maharashtra. The state-of-the-art factory now houses a total floor space of 11,700 sq mts and supports the MR Radio Frequency Coil, mobile surgery systems, and Ultrasound assembly businesses amongst other activities.    The expanded facility was inaugurated by Bert van Meurs, Chief Business Leader, Philips Image Guided Therapy, Arjen Radder, Business Leader, Philips Magnetic Resonance, Daniel Mazon, Vice Chairman and Managing Director, Philips Indian Subcontinent and Peeyush Kaushik, Head of Philips Healthcare Innovation Center, Pune.   Following the expansion, the Chakan facility will carry out manufacturing, servicing, and repair of MR coils with a significant global capacity, and is already providing a large volume of coils at the highest levels of global quality standards.    In addition to the factory expansion, Philips also announced the acquisition of 10 acres of land to build a new R&D centre to expand innovation capabilities in Pune to invest further in India. The current Pune R&D centre supports global businesses for multiple product lines, including image-guided Therapy, precision diagnosis and connected care.    Philips has hired over 3000 employees in India in 2021 during the Covid Second Wave. The firm has already presented 1,400+ job offers during the first quarter of 2022 and will continue recruiting talent this year.  ]]> <![CDATA[Avantor, Cytovance Biologics collaborate for plasmid DNA development]]> https://biospectrumindia.com/news/95/21225/avantor-cytovance-biologics-collaborate-for-plasmid-dna-development.html https://biospectrumindia.com/news/95/21225/avantor-cytovance-biologics-collaborate-for-plasmid-dna-development.html Thu, 12 May 2022 10:55:00 +0530 Avantor and Cytovance Biologics have entered into an agreement to manufacture research and GMP grade plasmids for biopharma customers. The collaboration extends Avantor's leadership in providing critical materials for next-generation vaccines and therapeutics focused on cell and gene therapy and mRNA drug manufacturing and expands Cytovance Biologics' global commercial reach.   The collaboration will allow Avantor to provide global biopharma customers and contract manufacturing organisations access to plasmid DNA and other mission-critical inputs used in research, clinical testing and manufacturing scale-up and commercialisation by leveraging Cytovance Biologics' plasmid cGMP manufacturing capabilities. ]]> <![CDATA[Bayer re-launches antifungal brand Canesten in India ]]> https://biospectrumindia.com/news/95/21219/bayer-re-launches-antifungal-brand-canesten-in-india-.html https://biospectrumindia.com/news/95/21219/bayer-re-launches-antifungal-brand-canesten-in-india-.html Wed, 11 May 2022 15:55:00 +0530 The Consumer Health division of Bayer has announced the launch of the new and improved range of Canesten, their anti-fungal treatment solution in India.   Available in powder and cream formats, the product range offers anti-fungal properties that help prevent and treat skin infections. An easy-to-use solution, Canesten is a full-cycle skin infection control formulation that not only provides relief from itching but also halts the spread of infection.    Canesten anti-fungal dusting powder is used in the prevention, therapy and follow-up treatment of superficial skin fungal infections and provides 5X relief vs. ordinary talcum powder from prickly heat, redness, skin irritation, itching, and fungal infection. Canesten cream, provides relief from ringworm, jock itch, skin candidiasis, athlete's foot, erythrasma and fungal nail infection, among other fungal skin infections. ]]> <![CDATA[PAG-led API platform to acquire Hyd-based Optimus Drugs]]> https://biospectrumindia.com/news/95/21217/pag-led-api-platform-to-acquire-hyd-based-optimus-drugs.html https://biospectrumindia.com/news/95/21217/pag-led-api-platform-to-acquire-hyd-based-optimus-drugs.html Wed, 11 May 2022 13:05:00 +0530 Alternative investment firm PAG, focused on Asia-Pacific, has announced that its private equity strategy along with consortium partners CX Partners and Samara Capital, has reached an agreement to acquire a controlling stake in Hyderabad-based pharmaceutical firm Optimus Drugs.   Optimus Drugs is a vertically integrated manufacturer of pharmaceutical products including advanced intermediates, active pharmaceutical ingredients (APIs) and finished drugs.   The deal marks the second acquisition by the consortium’s API platform, Sekhmet Pharmaventures, which aims to develop a best-in-class hub for the development and production of bulk drug ingredients. In 2020, the consortium acquired control of Chennai-based API manufacturer Anjan Drugs Pvt. Ltd. The businesses of the two companies are highly complementary and will provide a solid foundation for the platform to make further acquisitions.   PAG views India as a particularly attractive market. As of December 31, 2021, PAG has invested over $580 million in private equity deals in India, including the 2021 acquisition of Acme Formulation, a leading contract development and manufacturing outsourcing (CDMO) company with a focus on complex pharmaceutical products. ]]> <![CDATA[Omega Healthcare to hire 18,000 personnel in next one year]]> https://biospectrumindia.com/news/95/21205/omega-healthcare-to-hire-18000-personnel-in-next-one-year.html https://biospectrumindia.com/news/95/21205/omega-healthcare-to-hire-18000-personnel-in-next-one-year.html Tue, 10 May 2022 11:40:00 +0530 Omega Healthcare has announced its expansion in India with its recent plan to hire 4,500 professionals over the next two months. The expansion is planned for operations across Bengaluru, Chennai and Hyderabad. The company has seen significant growth in the last three years, moving up from 18,000 employees in 2020 to 26,000 in 2022. The technology-enabled service provider plans to further strengthen its capabilities, deepen domain expertise and build new solutions, by generating employment not only in tier-I but also the tier-II markets in India.    As part of its expansion plan, Omega Healthcare is inviting graduates from any field with minimal work experience to apply for the 18,000 open positions over the next 12 months. The company’s strategy for talent acquisition is to identify professionals who have the aptitude to recognise potential process improvements, bracket trends, and have strong logical thinking and communication skills.    Nitin Barekere, VP – Human Resources, Omega Healthcare, said, “We are keen on generating employment by targeting top fresh talent both in tier I and tier II cities that include Bengaluru, Hyderabad, Chennai, Navi Mumbai, Pune, Coimbatore, and Trichy."       ]]> <![CDATA[Cipla introduces RT Direct Multiplex real-time PCR kit for COVID-19]]> https://biospectrumindia.com/news/95/21202/cipla-introduces-rt-direct-multiplex-real-time-pcr-kit-for-covid-19.html https://biospectrumindia.com/news/95/21202/cipla-introduces-rt-direct-multiplex-real-time-pcr-kit-for-covid-19.html Tue, 10 May 2022 10:35:00 +0530 Mumbai-based Cipla has announced the commercialisation of ‘RT-Direct’ multiplex COVID-19 RT PCR Test kit in India, in partnership with Genes2Me. Cipla will be responsible for the distribution of RT Direct kits in India and has commenced supply of the same.    This kit is validated at the Indian Council of Medical Research (ICMR) approved Centre. It is based on the ‘gold standard RT-PCR method with coverage of three target genes specific to SARS-COV-2 along with IC, which is much more advanced than others having 1 or 2 target genes. This greatly increases the sensitivity of the RTPCR test.    RT-Direct test protocol does not require any RNA extraction process, making it faster and helping deliver results in just 45 minutes. It will also increase the throughput of any testing lab by threefold compared to the normal RT-PCR test protocol time of 120-150 minutes. ]]> <![CDATA[Intas Pharma offers ORGOVYX for advanced hormone-sensitive prostate cancer treatment in Europe]]> https://biospectrumindia.com/news/95/21204/intas-pharma-offers-orgovyx-for-advanced-hormone-sensitive-prostate-cancer-treatment-in-europe.html https://biospectrumindia.com/news/95/21204/intas-pharma-offers-orgovyx-for-advanced-hormone-sensitive-prostate-cancer-treatment-in-europe.html Tue, 10 May 2022 00:00:00 +0530 Myovant Sciences and Accord Healthcare (owned by Ahmedabad-based Intas Pharmaceuticals) have entered into an exclusive license agreement for Accord to commercialize relugolix for the treatment of advanced hormone-sensitive prostate cancer under the trade name ORGOVYX (relugolix, 120 mg) in the European Economic Area, United Kingdom, Switzerland and Turkey, with the right of first negotiation if Myovant decides to enter into licensing arrangements in countries in the Middle East, Africa and India. Under the terms of the agreement, Myovant will receive an upfront payment of $50 million and is eligible to receive commercial launch, sales-based and other milestones totaling up to $90.5 million.  In addition, Myovant is eligible to receive tiered royalties from the high-teens to mid-twenties on net sales. Myovant will continue to lead the global development of relugolix and provide initial product supply to Accord. Accord will be responsible for certain local clinical development, all commercialization for its territories, and has the option to manufacture relugolix in the future. Binish Chudgar, Managing Director of Accord, said, "Accord currently supplies around 1 in 3 injectable oncology medicines in Europe and this agreement underpins our commitment to patients with cancer and our continued investment in novel therapies. With over 1.9 million men living with prostate cancer in Europe, our partnership with Myovant will provide men living with hormone-sensitive advanced prostate cancer a new oral treatment option." Accord expects to launch ORGOVYX in Europe in the second half of calendar year 2022. ]]> <![CDATA[ENTOD Pharma unveils world's first nanotech-based under-eye gel serum]]> https://biospectrumindia.com/news/95/21182/entod-pharma-unveils-worlds-first-nanotech-based-under-eye-gel-serum.html https://biospectrumindia.com/news/95/21182/entod-pharma-unveils-worlds-first-nanotech-based-under-eye-gel-serum.html Thu, 05 May 2022 17:00:00 +0530 Mumbai-based ENTOD Pharmaceuticals has developed Eyecirque under eye gel serum in collaboration with UK-based cosmetic research laboratory NuSkin London.Based on an innovative plant-based biocellular formula containing a vitamin A+ C+ E complex, anti-aging antioxidants, skin brightening agents and naturally occurring ultra-moisturising ingredients, the gel gets easily absorbed into the skin around the eyes. Eyecirque is formulated for all skin types in internationally accredited skin research laboratories. Its ground-breaking nanotechnology-based biocellular formula contains carefully curated, safety tested and scientifically proven plant-based natural ingredients that are thoroughly tested for safety on the skin around the eyes.   Eyecirque is available online and in selected pharmacies and doctor's clinics. ]]> <![CDATA[Cloudbyz, Tech Mahindra focus on integrated clinical trial management solutions]]> https://biospectrumindia.com/news/95/21179/cloudbyz-tech-mahindra-focus-on-integrated-clinical-trial-management-solutions.html https://biospectrumindia.com/news/95/21179/cloudbyz-tech-mahindra-focus-on-integrated-clinical-trial-management-solutions.html Thu, 05 May 2022 11:40:00 +0530 US-based Cloudbyz has partnered with Tech Mahindra to provide integrated Clinical Trial Management Solutions. Tech Mahindra is a leading provider of digital transformation, consulting, and business re-engineering services and solutions.   The partnership, powered by Cloudbyz Clinical Research Management Platform and Tech Mahindra's industry-leading transformation services, will provide end-to-end clinical research management transformation to customers.   It will enable medical devices and pharmaceutical companies to be innovative, agile, and achieve efficiency across clinical trial research processes.   Kunal Purohit, Chief Digital Services Officer at Tech Mahindra, said, "As part of Tech Mahindra's NXT.NOW™ framework, which aims to enhance 'Human Centric Experience', we focus on investing in emerging technologies and solutions that enable digital transformation and meet the evolving needs of the customer. Organizations committed to clinical research will benefit immensely from the combination of the Cloudbyz solution portfolio and Tech Mahindra's Salesforce Solution Consulting & transformation expertise in the Healthcare & Life Sciences domain. Together, we aim to help our clients evolve and transform their clinical research management operations to become simple, agile, more efficient, and truly digital." ]]> <![CDATA[HempStreet partners with UK-based MGC Pharma]]> https://biospectrumindia.com/news/95/21173/hempstreet-partners-with-uk-based-mgc-pharma.html https://biospectrumindia.com/news/95/21173/hempstreet-partners-with-uk-based-mgc-pharma.html Wed, 04 May 2022 16:20:00 +0530 HempStreet, India's first research to retail venture in the medicinal cannabis sector, has partnered with European bio-pharma and phytocannabinoid company MGC Pharma. Headquartered in the UK, MGC Pharma has been working on polyherbal formulations based on cannabis and other phytopharmaceuticals. MGC Pharma has two proprietary formulations CimetrA and CannEpil. CimetrA is effective in arresting the cytokine storm, a symptom of  COVID-19. It is made of natural-sourced ingredients including Artemisinin, Curcumin, and Boswellia serrata. CannEpil is a phytocannabinoid-based medicine that effectively treats drug-resistant Epilepsy. Both products have undergone successful Phase II clinical trials. Through this partnership Indian patients will now have access to these medicines, starting with CimetrA, which had an immediate need as there are currently over 15 million individuals (approximately 30 per cent of all COVID-19 recoverees in India) said to be experiencing some form of post- or long- COVID- 19 related symptoms.The partnership will also accelerate HempStreet's upcoming venture – transdermal delivery technology for cannabinoids – to launch in the markets beyond Asia with the help of MGC Pharma's widespread distribution network in Australia, the UK, Brazil and Ireland. ]]> <![CDATA[Pfizer opens global drug development centre in Chennai]]> https://biospectrumindia.com/news/95/21172/pfizer-opens-global-drug-development-centre-in-chennai.html https://biospectrumindia.com/news/95/21172/pfizer-opens-global-drug-development-centre-in-chennai.html Wed, 04 May 2022 16:10:00 +0530 Pfizer has set up a global drug development centre at the Indian Institute of Technology (IIT) Madras Research Park in Chenna. The centre’s capabilities will include the development of both, active pharmaceutical ingredients (APIs) and finished dosage forms (FDFs) of differentiated products. The centre will develop and support products in global markets and Pfizer’s manufacturing centres worldwide.   The company has invested $20 million in the 61,000 sq ft research and technology centre at the IIT Madras Research Park. While this centre will be a part of a network of 12 global centres set up worldwide, it is the first and only one at present being set up by Pfizer in Asia.    This facility employs 250+ scientists and professionals from a range of scientific disciplines including Formulation Scientists and Pharmacists, Analytical Scientists with expertise in process, analytical and formulation medicinal sciences, Life Science specialists such as Microbiologists and Biotechnologists, Chemical Engineers, Data Scientists, and Program Managers.   The centre integrates two essential functions under the export-oriented undertaking of Pfizer: Pharmaceutical Sciences (PharmSci) and Global Technology and Engineering (GT&E) Center of Excellence. PharmSci is dedicated to the development of anti-infectives, oncolytics, sterile injectables, anaesthesia products, CNS products, and uniquely differentiated hospital products. GT&E pioneers next-generation API process and manufacturing technology to supply medicines to patients around the globe. ]]> <![CDATA[Alkem launches inhalation device Innohaler for COPD patients]]> https://biospectrumindia.com/news/95/21165/alkem-launches-inhalation-device-innohaler-for-copd-patients.html https://biospectrumindia.com/news/95/21165/alkem-launches-inhalation-device-innohaler-for-copd-patients.html Tue, 03 May 2022 14:05:00 +0530 Mumbai-based Alkem Laboratories has launched Innohaler, a DPI device to make life easier for Asthma and COPD (Chronic Obstructive Pulmonary Disease) patients.A Dry Powder Inhaler (DPI) is considered the most preferred drug delivery platform for such patients. Alkem is all set to fill the massive gap in accessibility for treating of respiratory diseases in India and has further made a big leap in the pulmonology vertical by introducing Innohaler, a DPI device.With the introduction of this device, Alkem is entering the core inhalation therapeutics and envisaging that the drug will reach the lungs effectively in each inhalation with added patient awareness and adherence programmes. ]]> <![CDATA[Lupin launches reference lab in Guwahati]]> https://biospectrumindia.com/news/95/21151/lupin-launches-reference-lab-in-guwahati.html https://biospectrumindia.com/news/95/21151/lupin-launches-reference-lab-in-guwahati.html Fri, 29 Apr 2022 16:00:00 +0530 Lupin Diagnostics has launched its Reference Laboratory in Guwahati in North East India. The expansion is in line with Lupin Diagnostics’ strategy to expand its presence across India and increase access to quality testing.    The reference laboratory in Guwahati has capabilities to conduct a broad spectrum of routine and specialised tests in the fields of molecular diagnostics, cytogenetics, flow cytometry, histopathology, cytology, microbiology, serology, hematology, immunology and routine biochemistry.   After Assam and West Bengal, Lupin Diagnostics is also setting up laboratories in Bihar, Jharkhand and Odisha to comprehensively cater to the Eastern region of India. These processing labs will be located in Patna (Bihar), Ranchi (Jharkhand) and Bhubaneshwar (Odisha), in addition to multiple cities across West Bengal. These labs will be connected to Lupin’s franchise collection centers, LupiMitra.  ]]> <![CDATA[Syngene registers Rs 2604 Cr revenue in Q4]]> https://biospectrumindia.com/news/95/21149/syngene-registers-rs-2604-cr-revenue-in-q4.html https://biospectrumindia.com/news/95/21149/syngene-registers-rs-2604-cr-revenue-in-q4.html Fri, 29 Apr 2022 11:00:00 +0530 Syngene International has announced its fourth-quarter and full-year results. The company reported revenue from operations has been up 15 per cent to Rs 758 crore for the fourth quarter and up 19 per cent to Rs 2604 crore for the full year ending March 31, 2022. Profit After Tax for the quarter, before accounting for exceptional items, was up seven per cent year-on-year to Rs 148 crore. Profit After Tax for the full year was up 10 per cent to Rs 421 crore.    Jonathan Hunt, MD and CEO, Syngene International, said, “I am pleased with the strong finish we had to the year and that we delivered results at the high end of our upgraded guidance range. Reflecting on the pandemic period, we created more than 1000 new jobs in the last two years and gained more than 100 new clients in the last year. We also extended and expanded our long-term partnership with Amgen Inc. and continued to invest in new capacity and technology to underpin future growth. Looking ahead, we see growing demand for research, development and manufacturing services around the world and we are well-positioned to take advantage of these new opportunities.”  ]]> <![CDATA[Biocon posts Rs 2,476 Cr revenue in Q4FY22]]> https://biospectrumindia.com/news/95/21148/biocon-posts-rs-2476-cr-revenue-in-q4fy22.html https://biospectrumindia.com/news/95/21148/biocon-posts-rs-2476-cr-revenue-in-q4fy22.html Fri, 29 Apr 2022 10:45:00 +0530 In Q4FY22 Biocon has registered revenue of Rs 2,476 crore, up 21 per cent; core EBITDA has been posted at Rs 815 crore, up 37 per cent; PBT(before Exceptional Items) is at Rs 384 crore, up 9 per cent. The biosimilars is up 48 per cent at Rs 982 crore; generics up 26 per cent at Rs 717 crore. Research services is up 15 per cent at Rs 758 crore.FY22 revenue has been posted at Rs 8,397 crore, up 14 per cent; the core EBITDA is up 18 per cent at Rs 2,669 crore, PBT (before Exceptional Item) has been registered at Rs 1094 crore, up 4 per cent.Kiran Mazumdar-Shaw, Executive Chairperson, Biocon and Biocon Biologics, said, "FY22 was a transformational year for Biocon. Key strategic moves in our biosimilars business position us for long-term growth and value creation for our stakeholders. We believe that the two strategic transactions, with Viatris and Serum Institute Life Sciences, will position Biocon Biologics as a world leading, unique, fully integrated biologics company with a strong differentiated portfolio of biosimilars and vaccines." ]]> <![CDATA[Thermo Fisher Scientific opens IEC facility in Hyd]]> https://biospectrumindia.com/news/95/21142/thermo-fisher-scientific-opens-iec-facility-in-hyd.html https://biospectrumindia.com/news/95/21142/thermo-fisher-scientific-opens-iec-facility-in-hyd.html Thu, 28 Apr 2022 16:55:00 +0530 Thermo Fisher Scientific has opened a new R&D and Engineering facility – India Engineering Center (IEC). The new centre was inaugurated by Minister for Industries and Commerce, Government of Telangana KT Rama Rao. The newly expanded India Engineering Center (IEC) is part of Thermo Fisher’s R&D Center of Excellence in India and will bring an additional 140 new jobs to the region.    Thermo Fisher's centre will employ over 450 engineers and vendor partners. The centre at Hyderabad is a 42,000 sq ft facility that includes the engineering labs and will support new product development and product sustenance for laboratory and analytical solutions for Thermo Fisher’s global sites. In addition, the facility will also attract top talent and open employment opportunities in Telangana.              ]]> <![CDATA[VAV Life Sciences introduces clean label cosmetics ingredients in Europe]]> https://biospectrumindia.com/news/95/21137/vav-life-sciences-introduces-clean-label-cosmetics-ingredients-in-europe.html https://biospectrumindia.com/news/95/21137/vav-life-sciences-introduces-clean-label-cosmetics-ingredients-in-europe.html Thu, 28 Apr 2022 16:00:00 +0530 Mumbai-based VAV Life Sciences has introduced its range of COSMOS-approved clean label ingredients, for the cosmetic industry in Europe. The products include lecithin and phospholipid delivery agents naturally derived from plant sources like soya and sunflower.   Lecithins are ingredients that can be engineered to form liposomes, structures that have a bilayer membrane resembling the basic cellular membrane structure of the skin. This similarity makes them excellent delivery agents that allow cosmetic actives to penetrate the skin.   VAV will market its clean label products under the brands LECIVA-SMAP (soya lecithin), LECIVA-DIFUZ (soya phospholipids), and LECIVA-LITHE (soya phospholipids), LECIVA-DIFUZ M (sunflower phospholipids), LECIVA-LITHE M (sunflower phospholipids).   ]]> <![CDATA[Govt, pharma CEOs discuss role of research, regulatory framework at 'Indian Pharma Vision 2047' ]]> https://biospectrumindia.com/news/95/21122/govt-pharma-ceos-discuss-role-of-research-regulatory-framework-at-indian-pharma-vision-2047-.html https://biospectrumindia.com/news/95/21122/govt-pharma-ceos-discuss-role-of-research-regulatory-framework-at-indian-pharma-vision-2047-.html Tue, 26 Apr 2022 17:20:00 +0530 Secretary, Department of Pharmaceuticals, S Aparna and Union Health Secretary, Rajesh Bhushan recently chaired a panel discussion with the pharmaceuticals industry CEOs on the second day of the 7th international conference on the pharma and medical device sector. Also present was Anurag Jain, Secretary, DPIIT on the theme 'Indian Pharma vision 2047.'Aparna said, “There are three strands which we should focus on: regulatory framework, research framework along with the resources including fiscal and talent." She added, “Collaboration between large companies and start-ups, industry and academia collaboration by making public research more accessible and collaboration across sectors including the drug, devices sector along with the digital sector will be the main pillar of growth in the years to come."Highlighting the importance of the four pillars of the Ayushman Bharat Programme, the Union Health Secretary said that the government is planning to operationalise around 1.5 lakh Ayushman Bharat Health and Wellness centres in the country by December 2022 out of which 1.17 lakhs have already been operationalised. He further stated that the government is planning to spend Rs 65,000 crores in the next five years till 2025-26 to create health infrastructure at district levels.Jain mentioned, "We should also focus on discovering in India, innovate in India and then Make in India. This is especially critical for the pharma sector. He further added that Intellectual Property is an extremely important area for the Pharma sector and we as a part of the government are committed to playing a facilitative role in the sector."CEOs of various pharma companies, senior officials of the ministry, FICCI were also present at the panel discussion. ]]> <![CDATA[GSK launches once daily, single inhaler-triple therapy for COPD patients ]]> https://biospectrumindia.com/news/95/21121/gsk-launches-once-daily-single-inhaler-triple-therapy-for-copd-patients-.html https://biospectrumindia.com/news/95/21121/gsk-launches-once-daily-single-inhaler-triple-therapy-for-copd-patients-.html Tue, 26 Apr 2022 14:45:00 +0530 GlaxoSmithKline Pharmaceuticals has launched Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol), the first single-inhaler triple therapy (SITT) in India for Chronic obstructive pulmonary disease (COPD) patients in a once-daily regime.   The launch follows the product’s approval by the Drugs Controller General of India (DCGI) for use of Trelegy Ellipta as a maintenance treatment to prevent and relieve symptoms associated with COPD in patients aged 18 and above.    In usual clinical care, treatment with single-inhaler Trelegy Ellipta results in significantly more patients with health status improvements and greater lung benefit, versus multi-inhaler triple therapy, with similar safety profiles.   Trelegy is delivered via the innovative Ellipta inhaler that provides accurate dosing through its consistent dose delivery mechanism and is associated with less inhaler teaching time compared to other commonly used inhalers.      ]]> <![CDATA[Rossari Biotech unveils nanotech-based antimicrobial surface coating]]> https://biospectrumindia.com/news/95/21119/rossari-biotech-unveils-nanotech-based-antimicrobial-surface-coating.html https://biospectrumindia.com/news/95/21119/rossari-biotech-unveils-nanotech-based-antimicrobial-surface-coating.html Tue, 26 Apr 2022 11:40:00 +0530 Mumbai-based Rossari Biotech has announced the launch of Dr Nanoxa, a new age antimicrobial surface coating infused with nanotechnology which provides bio-security from residual infections caused by bacteria and viruses including SARS CoV for 30 days. The product is made in India and has successfully been tested by National Accreditation Board for Testing and Calibration Laboratories (NABL) certified laboratories using international standards and has proven to inactivate urinary tract infection (UTI) causing bacteria and SARS-CoV-2 (Coronavirus) for 30 days of application. The product has an environment-friendly coating which takes away the negative effects of the chemicals. Initially, the company will be launching with a 200 ml spray bottle for the B2C segment and five-litre cans along with empty spray bottles for the B2B/institutional segment. The product comes as a perfect solution since it provides effective protection against Coronavirus (SARS-CoV-2). The product will be available across various e-commerce marketplaces. It is very easy to use as it comes in a spray bottle and the active ingredients in Dr Nanoxa are a mixture of metal nanoparticles, encapsulated in an intelligent polymer chain to give tri-layer prolonged protection from harmful microbes for up to 30 days. These metal nanoparticles have long been recognised as antimicrobial agents. Combined with nanotechnology, they ensure prolonged protection. ]]> <![CDATA[MaxiVision eyes Rs 500-Cr expansion plans ]]> https://biospectrumindia.com/news/95/21117/maxivision-eyes-rs-500-cr-expansion-plans-.html https://biospectrumindia.com/news/95/21117/maxivision-eyes-rs-500-cr-expansion-plans-.html Mon, 25 Apr 2022 18:30:00 +0530 MaxiVision Eye Hospitals has announced aggressive expansion plans to neighbouring states, Tamil Nadu, Karnataka and Gujarat. The group posted close to Rs 200-crore revenue from 21 eye care centres during the last financial year 21/22.   The JV Sarath Maxivision Eye Hospital, which started with one hospital, is now having three super speciality hospitals in Warangal, Khammam, Karimnagar, and also seven Vision Centres in deep rural Telangana.    The group signed off its second JV in November 2021 with Dr Ramalinga Reddy and Maxivision Dr Ramalinga Reddy Eye Hospital will expand to Guntur and Macherla by September 2022.    MaxiVision has launched one new JV in Hyderabad, Telangana, one in Rajkot, Gujarat, and also Greenfield entry to the Tamil Nadu market. This will add five hospitals to the network, and around Rs 100 crore to the current topline. This year the group has budgeted Rs 500-crore topline, by the end of FY 22/23 opening more hospitals in Telangana, Andhra Pradesh, Tamil Nadu and Gujarat.   The group has launched its entry to Gujarat with one of the leading practices, in Rajkot, Nethradeep Eye Hospitals. Dr Vasanth Sapovadia, who is a renowned ophthalmologist in West with over 35 years of experience, will head as Regional Medical Director for Saurashtra Region. This new JV, Nethradeep Maxivision will expand to other districts in Saurashtra, namely Morbi, Bhuj, Jamnagar, Porbandar etc within the next six to eight months.    The group entered Tamil Nadu on March 21/22, with one Super Specialty eye hospital in Tiruchirappalli. Dr Shibu Varkeywill head this cluster as Regional Medical Director, which will spearhead our aggressive expansion plans in Chennai, and other districts in Tamil Nadu, Tanjore, Kumbakonam, Salem, Madurai, and Erode throughout 22/23.   In the next phase post-September, the group will finalise five more JV in Telangana, AP, Maharashtra, Gujarat, and Karnataka, with reputed doctors of the region. In 22/23, the group will add 20 hospitals next year to the group and be a 55 hospitals network, led by a team of 160+ doctors and around 1000 patient care team.     ]]> <![CDATA[FICCI, KPMG in India release report impact of pharma industry on India's economy post covid]]> https://biospectrumindia.com/news/95/21115/ficci-kpmg-in-india-release-report-impact-of-pharma-industry-on-indias-economy-post-covid.html https://biospectrumindia.com/news/95/21115/ficci-kpmg-in-india-release-report-impact-of-pharma-industry-on-indias-economy-post-covid.html Mon, 25 Apr 2022 17:40:00 +0530 A report titled ‘Impact of the pharma industry on the Indian economy in the post-COVID era’ was released at the 7th International Conference on Pharma and Medical Sector.  It is a collaborative effort by FICCI and KPMG in India and brings together insights and knowledge from sector stakeholders, the government, leading pharmaceutical and medical device industry leaders, and is complemented with extensive secondary research.   Commenting on the report, Vijay Chawla, Partner and Head – Risk Advisory and Head -Life Sciences, KPMG in India said, “The Indian pharmaceutical industry has demonstrated resilience in its ability to serve the population in India as well as across the globe, ensuring accessibility and most importantly affordability of quality medicines. There is no doubt that the COVID-19 pandemic exposed certain systemic gaps in the industry, but it also provided the right impetus to the industry to innovate and move up the pharma value chain."   The report focuses on some critical trends that are currently leading the path for the industry including accelerated research and innovation, focus on new drug discovery, digital transformation, strengthening manufacturing and supply chains, and the need for a robust regulatory environment to attain sustainable and equitable healthcare. The Indian government, as always has been an active stakeholder in the success and growth of the industry, and with measures such as production linked incentive schemes, bulk drugs, and medical device parks, it continues to be the pillar of support to the industry.” ]]> <![CDATA[Indus Health Plus introduces genetic testing solution MEDNAwise]]> https://biospectrumindia.com/news/95/21109/indus-health-plus-introduces-genetic-testing-solution-mednawise.html https://biospectrumindia.com/news/95/21109/indus-health-plus-introduces-genetic-testing-solution-mednawise.html Mon, 25 Apr 2022 14:55:00 +0530 Pune-based Indus Health Plus is expanding its genetic testing portfolio by launching MEDNAwise, a genetic solution in precision medicine. MEDNAwise testing helps to understand which drug suits best, manage treatment and increase its effectiveness. It can also be used as a predictive personalised medication guide for those who like to be one step ahead.The MEDNAwise testing is based on pharmacogenomics, a study that uses your genetic information to predict your response to certain drugs/medicines. This can help the doctors prescribe safer and more effective medication. MEDNAwise is saliva based user-friendly genetic test which can be done from the comfort of home. It is designed for all age groups and has 11 categories and 72 medicines covered related to different health departments   ]]> <![CDATA[Glenmark unveils Teneligliptin + Pioglitazone combo drug for Type 2 diabetes in India]]> https://biospectrumindia.com/news/95/21108/glenmark-unveils-teneligliptin-pioglitazone-combo-drug-for-type-2-diabetes-in-india.html https://biospectrumindia.com/news/95/21108/glenmark-unveils-teneligliptin-pioglitazone-combo-drug-for-type-2-diabetes-in-india.html Mon, 25 Apr 2022 11:40:00 +0530 Glenmark Pharmaceuticals has launched a novel fixed-dose combination (FDC) of a widely used DPP4 inhibitor (Dipeptidyl Peptidase 4 inhibitor), Teneligliptin, with Pioglitazone. This is the only available DPP4 and Glitazone combination brand in India for adults with uncontrolled Type 2 diabetes. Glenmark has launched this FDC under the brand name Zita Plus Pio, which contains Teneligliptin (20 mg) + Pioglitazone (15 mg), to be taken once a day.The combination of Teneligliptin + Pioglitazone will provide a synergistic approach wherein Teneligliptin will optimally improve β cell sensitivity, and Pioglitazone will effectively reduce insulin resistance. Glenmark is the first company in India to market the innovative FDC of Teneligliptin + Pioglitazone, which is approved by the DCGI (Drug Controller General of India). This fixed dose combination will be useful for patients who require treatment with Teneliglitptin and Pioglitazone (as separate drugs) to improve glycemic control reducing insulin resistance.   ]]> <![CDATA[Ayush Ministry receives LoI from 28 companies worth Rs 6000 Cr]]> https://biospectrumindia.com/news/95/21103/ayush-ministry-receives-loi-from-28-companies-worth-rs-6000-cr.html https://biospectrumindia.com/news/95/21103/ayush-ministry-receives-loi-from-28-companies-worth-rs-6000-cr.html Fri, 22 Apr 2022 16:25:00 +0530 On the second day of The Global Ayush Investment and Innovation Summit 2022, the Ayush Ministry has received LoI from 28 companies to the tune of Rs 6000 crores. The investments will help create over 5.5 lakh jobs and positively impact over 76 lakh lives. According to Vaidya Rajesh Kotecha, Secretary, Ministry of Ayush, there are various MOUs signed with different countries as well as the Ministry of Defence to start Ayush facilities in over 35 Cantonment areas across India, and with the Ministry of Science and Technology to promote cross-collaboration with CSIR for joint PhD programmes and mechanistic studies in Ayush.He added, "The government budget in the sector has increased over four times from Rs 691 crore in 2014 to Rs 3050 crore in the last budget. The market also has grown exponentially from Rs 22,000 crores in 2014 to Rs 1.14 lakh crores." ]]> <![CDATA[J&J brand Neutrogena unveils new skin care products in India]]> https://biospectrumindia.com/news/95/21106/jj-brand-neutrogena-unveils-new-skin-care-products-in-india.html https://biospectrumindia.com/news/95/21106/jj-brand-neutrogena-unveils-new-skin-care-products-in-india.html Fri, 22 Apr 2022 00:00:00 +0530 Neutrogena, owned by parent company Johnson & Johnson, has launched its new range, Neutrogena Bright Boost for Indian consumers, to address the increasing problem of skin dullness. For the first time, Neutrogena has formulated a range to meet the unique skin brightening needs of Indian women. This customized formulation boosts the surface skin cell renewal process by 10 times, helping achieve smoother, brighter, and more-even skin tone in just a week. With the Bright Boost range, Neutrogena aims to help women achieve a radiant, more-even skin tone.  The three key products in the new range- Resurfacing Micro Polish, Illuminating Serum, and Gel Cream, effectively address dullness and pigmentation. These products are powered by the revolutionary dermatologist-preferred ingredient, Neoglucosamine that has been developed in-house.  The launch of the Bright Boost range will be supported by a 360-degree digital-first outreach programme across platforms and further amplified through a digital film that introduces the Bright Boost range and the revolutionary dermatologist-preferred ingredient Neoglucosamine. ]]> <![CDATA[Camex Wellness introduces menstrual pain relief device WELME]]> https://biospectrumindia.com/news/95/21094/camex-wellness-introduces-menstrual-pain-relief-device-welme.html https://biospectrumindia.com/news/95/21094/camex-wellness-introduces-menstrual-pain-relief-device-welme.html Thu, 21 Apr 2022 12:15:00 +0530 Camex Wellness has introduced a wearable, and easy-to-carry device that uses TENS (Transcutaneous Electrical Nerve Stimulation) technology to relieve period pain - WELME. The device has been developed to provide comfort to menstruating females suffering from period cramps, which are also scientifically known as Dysmenorrhea.   Preksha Chopra, Founder - Welme, “My R&D and design team have managed to incorporate the smart technology of TENS into a pocket-size product." ]]> <![CDATA[Flutura Business Solutions collaborates with Lupin]]> https://biospectrumindia.com/news/95/21093/flutura-business-solutions-collaborates-with-lupin.html https://biospectrumindia.com/news/95/21093/flutura-business-solutions-collaborates-with-lupin.html Thu, 21 Apr 2022 12:05:00 +0530 Flutura Business Solutions, an Industrial IoT Intelligence provider, is collaborating with global pharma major Lupin to accelerate its digital transformation and automation journey.   Lupin and Flutura will collaborate to create a massive pharmaceutical data lake as the foundation for configuring digital twins of mission-critical pharmaceutical processes as well as bolt-on battle-tested AI applications at scale that can sense and respond to events in real-time.   A digital data foundation will host data for all of Lupin's operational processes. Starting with manufacturing, quality and sales and marketing functions, it will expand to finance and supply chain functions until all the information converges into a Central Data Lake.   Flutura will support Lupin in accelerating its AI journey and develop advanced analytics and high-value use cases to uncover actionable insights from the massive data lake.                              ]]> <![CDATA[Transcell Oncologics, ViNS Bioproducts ink MoU for potency testing of anti-venoms]]> https://biospectrumindia.com/news/95/21098/transcell-oncologics-vins-bioproducts-ink-mou-for-potency-testing-of-anti-venoms.html https://biospectrumindia.com/news/95/21098/transcell-oncologics-vins-bioproducts-ink-mou-for-potency-testing-of-anti-venoms.html Thu, 21 Apr 2022 00:00:00 +0530 A Memorandum of Understanding (MoU) has been signed between Hyderabad-based Transcell Oncologics and ViNS Bioproducts to adopt NeuroSAFE, recently launched by Transcell, to undertake potency testing of anti-venoms and this will be a revolutionary next generation cruelty free operation. Due to the complex biological nature of venoms, the potency of both venoms and anti-venoms is traditionally tested in small animals, as recommended by the WHO. Sacrificing small animals for venom and anti-venom potency measurements batch-wise is one of the most deliberated topics of cruelty caused, encouraging the manufacturers to apply the ‘3Rs’—replacement, reduction, and refinement in animal use. Ethical guidelines limit the testing, resulting in inconclusive test results which often do not meet the industry requirements. NeuroSAFE is a cruelty free workstation solution that combines human induced pluripotent stem cell technology and modern robotic process automation as a dependable resolution to the anti-venom Industry to go cruelty free in their practice. “NeuroSAFE is built on configured in vitro human cellular platform that can hold scale, throughput by being phenotypically responsive and genotypically reactive. We envisage NeuroSAFE to be a disruptive testing strategy delivering accurate digital scores like ED50 and LD50 on human specific Neurotoxicity, Neurovirulence like read out patterns in the most humane method – A much needed in reducing cruelty to animals” said Dr Subhadra Dravida, Founder and CEO, Transcell Oncologics.   ]]> <![CDATA[Aura Air unveils smart air-purifiers in India]]> https://biospectrumindia.com/news/95/21089/aura-air-unveils-smart-air-purifiers-in-india.html https://biospectrumindia.com/news/95/21089/aura-air-unveils-smart-air-purifiers-in-india.html Wed, 20 Apr 2022 14:15:00 +0530 Aura Air, a publicly listed company with the Tel-Aviv Stock Exchange (TASE), has launched its smart air management platform in India. Aura Air air-purifiers detect, capture, and kill viruses, bacteria, mold and can remove airborne particles as small as 0.3 microns, including allergens and viruses. These IoT-enabled devices connect to a mobile phone and deliver real-time updates on the overall indoor and outdoor Air Quality Index (AQI) based on VOC (Volatile Organic Compounds), CO2 (Carbon Dioxide), CO (Carbon Monoxide), and fine particulate matter levels.    Aura Air purifiers have successfully cleared clinical trials confirming their effectiveness against the corona virus in a study conducted at Sheba Medical Center and the results have been published in the world Journal of Surgery and Surgical Research. Aura Air is also in the process of getting Food and Drug Administration, USA approval.     ]]> <![CDATA[BDR Pharma launches gastric cancer drug FURMECIL]]> https://biospectrumindia.com/news/95/21086/bdr-pharma-launches-gastric-cancer-drug-furmecil.html https://biospectrumindia.com/news/95/21086/bdr-pharma-launches-gastric-cancer-drug-furmecil.html Wed, 20 Apr 2022 13:00:00 +0530 Mumbai-based BDR Pharmaceuticals has launched oral drug FURMECIL, a combination of three drugs - Tegafur, Gimeracil and Oteracil (also known as S-1) to treat advanced gastric cancer.   Furmecil is soon going to be available in the Indian market, in the form of capsules in two strengths (Tegafur 15 mg + Gimeracil 4.35 mg + Oteracil 11.80 mg & Tegafur 20 mg + Gimeracil 5.80 mg + Oteracil 15.80 mg).   Commenting on the launch, Raheel Shah, Director Business Development on behalf of BDR Pharmaceuticals said, “Our focused launch of such first time ever newly advanced molecule in treatment of various cancer indications, is testimony to our solid commitment to providing access to affordable medicines for Indian cancer patients with high quality standards without compromising patient’s safety”. Gastric cancer remains one of the most important malignancies worldwide in terms of incidence and mortality. It is the fourth most common malignant disease and the second leading cause of cancer-related deaths worldwide. The treatment consists of targeted molecules, a combination of local surgery and radiation therapy as well as systemic chemotherapy. The combination therapy with S-1 has been in progress to obtain a better survival benefit, lower cost and better quality of life as per Indian Journal of Medical and Paediatric Oncology.     ]]> <![CDATA[Intas Pharma partners with Comera Life Sciences for bio-innovative biologic medicines]]> https://biospectrumindia.com/news/95/21081/intas-pharma-partners-with-comera-life-sciences-for-bio-innovative-biologic-medicines.html https://biospectrumindia.com/news/95/21081/intas-pharma-partners-with-comera-life-sciences-for-bio-innovative-biologic-medicines.html Tue, 19 Apr 2022 16:40:00 +0530 Ahmedabad-based Intas Pharmaceuticals has announced a research collaboration with US-based Comera Life Sciences, to develop a new generation of bio-innovative biologic medicines to improve patient access, safety, and convenience.   Under the terms of the partnership agreement, Comera will develop a differentiated formulation of an Intas product using Comera's innovative proprietary SQore formulation platform.   Intas will initially provide research funding with the option to acquire global rights to the formulation through an exclusive license with responsibility for subsequent development and commercialisation.   Binish Chudgar, Vice Chairman and Managing Director of Intas Pharmaceuticals said, "This collaboration will accelerate our quest to develop innovative, value-added medicines that can make a difference in patients' lives globally."     ]]> <![CDATA[Metropolis Healthcare forays into Puducherry]]> https://biospectrumindia.com/news/95/21077/metropolis-healthcare-forays-into-puducherry.html https://biospectrumindia.com/news/95/21077/metropolis-healthcare-forays-into-puducherry.html Tue, 19 Apr 2022 14:45:00 +0530 Metropolis Healthcare has launched an advanced diagnostic testing centre in Puducherry. The 1250 sq ft laboratory can conduct around 500 sample testing per day with a quick turnaround time and high-quality reports.   Metropolis Laboratory, Puducherry will offer different tests ranging from basic day-to-day pathology tests to high-end molecular diagnostics tests at reasonable rates. The new laboratory is located at Lister Metropolis, no.141, Lal Bahadur Shastri Street, (Bussy Street). ]]> <![CDATA[India approves US-based Navidea Biopharma's Lymphoaim for cancer detection]]> https://biospectrumindia.com/news/95/21075/india-approves-us-based-navidea-biopharmas-lymphoaim-for-cancer-detection.html https://biospectrumindia.com/news/95/21075/india-approves-us-based-navidea-biopharmas-lymphoaim-for-cancer-detection.html Tue, 19 Apr 2022 12:25:00 +0530 US-based Navidea Biopharmaceuticals has announced the regulatory approval of Lymphoaim by the Central Drugs Standard Control Organisation (CDSCO).   Tc99m tilmanocept is approved for imaging and intraoperative detection of sentinel lymph nodes draining a primary tumour in adult patients with breast cancer, melanoma, or localised squamous cell carcinoma of the oral cavity.   External imaging and intraoperative evaluation may be performed using a gamma detection device. Tc99m tilmanocept is designed for the precise identification of lymph nodes that drain from a primary tumour, which have the highest probability of harbouring cancer.   Bengaluru-based Sayre Therapeutics will lead Lymphoaim commercialisation efforts in India through a previously announced exclusive license and distribution agreement with Navidea. Sayre Therapeutics specialises in innovative treatment and medical device commercialisation in South Asia. ]]> <![CDATA[Fujifilm India completes installation of 50,000 medical devices in India]]> https://biospectrumindia.com/news/95/21069/fujifilm-india-completes-installation-of-50000-medical-devices-in-india.html https://biospectrumindia.com/news/95/21069/fujifilm-india-completes-installation-of-50000-medical-devices-in-india.html Mon, 18 Apr 2022 16:15:00 +0530 Fujifilm India has completed the installation of 50,000 medical equipment devices in India. Passing the 50K milestone, the brand has also released a campaign video outlining the company’s deep focus on improving healthcare in the country and the importance of access to diagnostic services.    The campaign, titled ‘#50K and Counting - Hitting the Milestone and Getting Healthier Together’, highlights Fujifilm’s achievements in the medical imaging and devices division, continuously working towards spreading awareness regarding healthier choices via timely detection of diseases. It also features testimonials from Fujifilm customers, commending the company’s products, after-sales support and a wide network.    Fujifilm has installed its medical solutions across India, ranging from top metropolitan cities to remote areas such as Leh, Ladakh, Northeast India and Jharkhand and Bihar, among other regions.  ]]> <![CDATA[Sanskriti University organises seminar on drug repurposing]]> https://biospectrumindia.com/news/95/21065/sanskriti-university-organises-seminar-on-drug-repurposing.html https://biospectrumindia.com/news/95/21065/sanskriti-university-organises-seminar-on-drug-repurposing.html Mon, 18 Apr 2022 13:15:00 +0530 Sanskriti University School of Pharmacy recently organised a seminar on 'Drug Repurposing and Applications of QSAR in Drug Discovery.' Dr Anshuman Dixit, Scientist-E (Institute of Life Sciences) was a key speaker of the seminar. The seminar was aimed to familiarise students with the application of quantitative structure-activity relationship (QSAR) in Drug Discovery. The seminar was attended by Chancellor Sachin Gupta, Pro-Vice-Chancellor Rakesh Premi, Faculty Members and students of the School of Pharmacy.   During his inaugural speech, Dr Anshuman Dixit said, “Repurposing or repositioning refers to the usage of pre-existing drugs to tackle a disease other than the one that the drug was originally designed to target."   Dr Dixit also shared detailed information on the conventional drug development process involving de novo detection and identification of new molecular entities, including the five phases, discovery and pre-clinical, safety review, clinical research, FDA review and FDA post-market safety monitoring. It is a time-consuming and expensive procedure with a high risk of failure as highlighted briefly before, while on the other hand, the drug repositioning has only four steps, including (a) compound identification; (b) compound acquisition; (c) development; and (d) FDA post-market safety monitoring. The development of next-generation computational methods using Artificial Intelligence (AI), Machine Learning (ML) and network medicine approaches have positively impacted the different stages of a drug development process.   The increasing use of IT in the discovery of new molecular entities encourages the use of modern molecular-modelling tools to help teach important concepts of drug design to chemistry and pharmacy undergraduate students, said Sachin Gupta, Chancellor of Sanskriti University.   The seminar culminated with a vote of Thanks by Pro Vice-Chancellor Rakesh Premi.   ]]> <![CDATA[Lodha launches Lifesciences Hub at Palava near Mumbai]]> https://biospectrumindia.com/news/95/21050/lodha-launches-lifesciences-hub-at-palava-near-mumbai.html https://biospectrumindia.com/news/95/21050/lodha-launches-lifesciences-hub-at-palava-near-mumbai.html Wed, 13 Apr 2022 18:50:00 +0530 Lodha closed a deal with Encube Ethicals, dedicated to topical products, to develop ~100,000 sq ft flagship R&D ‘Centre of Excellence’ at Palava. The project is part of the Lodha Lifesciences Hub, which is spread across 25 acres and is Mumbai’s first systematically developed life sciences cluster.Expected to complete by 2023, the project will entail the development of Encube Ethicals’ R&D Centre of Excellence. In line with Lodha’s commitment to fostering growth and contributing towards a larger goal of nation-building, this strategic partnership will further provide a host of job opportunities in the city.This project will be carried out in two phases, with the first phase being delivered by next year. Encube Ethicals plans to have 250 R&D-related jobs in the first building itself. The Lodha Lifesciences Hub at Palava offers next-generation lab spaces. It is built on the core principles of ESG with a host of ecosystem benefits, 100 per cent compliant spaces, and all requisite government approvals in place. It is centrally located near the current hubs of Mahape, Taloja, Ambernath, and more than ~1000 R&D employees are already residing in Palava. ]]> <![CDATA[Akums acquires Ankur Drugs' HP plant]]> https://biospectrumindia.com/news/95/21047/akums-acquires-ankur-drugs-hp-plant.html https://biospectrumindia.com/news/95/21047/akums-acquires-ankur-drugs-hp-plant.html Wed, 13 Apr 2022 16:05:00 +0530 Akums Drugs & Pharmaceuticals has acquired a facility from Ankur Drugs and Pharmaceuticals. The facility is located in Nalagarh in Solan, Himachal Pradesh. With this acquisition Akums’ will boost its production capacities for general oral tablets and oral liquids. The planned capacities of the new facility are six billion units of tablets and 90 million units of oral liquids per annum. This facility is most likely to be fully operational by the end of 2022. Founder, Promoter and Director, Akums Drugs & Pharmaceuticals, Sandeep Jain says, “With this new facility in, we are trying to bridge some more capacity gaps in the pharma industry.” Founder, Promoter and Director, Akums Drugs & Pharmaceuticals, Sanjeev Jain says, “This expansion is a step towards achieving our goal of 20% market share. The operations at our Kotdwar plant have begun recently, while our new plant in Himachal Pradesh is likely to start its operations by December 2022.” ]]> <![CDATA[Mankind Pharma launches rapid testing pregnancy device]]> https://biospectrumindia.com/news/95/21048/mankind-pharma-launches-rapid-testing-pregnancy-device.html https://biospectrumindia.com/news/95/21048/mankind-pharma-launches-rapid-testing-pregnancy-device.html Wed, 13 Apr 2022 00:00:00 +0530 Prega News, Mankind Pharma’s pregnancy test kit brand, has launched a new and advanced pregnancy detection test kit for the Indian market. Having 82% share in the market, Prega News is the No. 1 Pregnancy Detection Test Kit in India, and with the launch of Prega News Advance it strives to continually provide advanced testing solutions for confirming the pregnancy. Prega News advance is a single-step pregnancy test device that does not require the collection of urine in a dropper or a container, making it the easiest and most convenient method to test pregnancy at home. It is an easy to grip mid-stream test device used under urine stream directly while the absorbent tip of the device without the use of dropper collects the sample and readily provides accurate results in just 3 minutes. Commenting on the launch, Joy Chatterjee, General Manager, Sales and Marketing, said, “Our product has received overwhelming responses in the first phase of the launch and we are expecting the same enthusiasm towards the product in the future.”  After the first phase of the launch the products will be available in eight states. Consumers will be able to access the products in offline and online stores of Delhi, Mumbai, Pune, Lucknow, Guwahati, Chennai, Haryana and Kolkata. The product is competitively priced at Rs 100 only. While in the second phase, the brand aims to proliferate deeper into the markets by availing the products in all parts of the country.  ]]> <![CDATA[Generic Aadhaar opens 29 franchises in one day]]> https://biospectrumindia.com/news/95/21031/generic-aadhaar-opens-29-franchises-in-one-day.html https://biospectrumindia.com/news/95/21031/generic-aadhaar-opens-29-franchises-in-one-day.html Mon, 11 Apr 2022 12:10:00 +0530 Generic Aadhaar has opened 29 franchises in 29 different districts across India in a single day.    Generic Aadhaar stores were inaugurated in both metro and remote cities like Chennai, Guntur, Thiruvarur, Ahmedabad, East Delhi, Navi Mumbai, Mahabubnagar, Gaya, Thane, Bangalore, Lucknow, Bardhwan, West Tripura, etc. Currently, there are Generic Aadhaar franchise owners in every state. Of 29 stores launched, 11 stores are owned by women.    Arjun Deshpande, Founder & CEO of Generic Aadhaar, said, “We firmly believe that India needs more job creators, not job seekers. Through our business model, we are trying to deliver the same."   The company is committed to provide employment opportunities to 500+ people.    ]]> <![CDATA[Glenmark bags DCGI approval for Ph 1 trial of novel cancer molecule ]]> https://biospectrumindia.com/news/95/21029/glenmark-bags-dcgi-approval-for-ph-1-trial-of-novel-cancer-molecule-.html https://biospectrumindia.com/news/95/21029/glenmark-bags-dcgi-approval-for-ph-1-trial-of-novel-cancer-molecule-.html Mon, 11 Apr 2022 10:55:00 +0530 Glenmark Pharmaceuticals has announced that its subsidiary Glenmark Specialty (Glenmark) received approval from the Indian drug regulator, Drug Controller General of India (DCGI), to conduct a Phase 1 clinical trial of its novel small-molecule, GRC 54276, a hematopoietic progenitor kinase 1 (HPK1) inhibitor. GRC 54276 is one of the many novel molecules from Glenmark’s resident, Innovative Medicines Group, headed by Dr Nikhil Amin, Chief Scientific Officer, specialising in the development of novel molecular entities for critical unmet medical needs. HPK1 is a key regulator of T cell, B cell and dendritic cell-mediated immune responses, which improves antitumor immunity by activating and priming T cells. GRC 54276 has shown tumour cell killing ability in preclinical studies as a single agent and as well in combination with checkpoint inhibitors, making it a high-priority target in immuno-oncology.The study will evaluate the safety and tolerability of GRC 54276 as a monotherapy, and also in combination with checkpoint inhibitors in patients with advanced solid tumours and Hodgkin’s lymphoma. Glenmark will initiate Phase 1 clinical trial in India by June 2022, and also plans to file an IND in the US and Clinical Trial Applications in Europe to kick off a fully global clinical study programme. ]]> <![CDATA[Covaxin price drops to Rs 225 in private hospitals]]> https://biospectrumindia.com/news/95/21028/covaxin-price-drops-to-rs-225-in-private-hospitals.html https://biospectrumindia.com/news/95/21028/covaxin-price-drops-to-rs-225-in-private-hospitals.html Sat, 09 Apr 2022 00:00:00 +0530 The price of Bharat Biotech's COVID-19 vaccine COVAXIN has been revised to Rs 225 per dose for private hospitals.The private hospitals are requested to provide COVAXIN at the revised rate effective 10th April 2022. The price differential with any existing stocks in private hospitals shall be compensated in the form of additional doses.Fresh stocks of COVAXIN are available and ready for supplies. Bharat Biotech has more than 50 million doses of the vaccine readily available in vials, and over 200 million doses as drug substance. Additional production capacity is also available to meet product demand.COVAXIN is formulated uniquely such that the same dosage can be administered to adults and children alike. It is a ready-to-use a  liquid vaccine, stored at 2-8°C, with 12 months shelf life and multi-dose vial policy. The same vaccine can also be used for 2 dose primary immunization  and for booster dose vaccinations. ]]> <![CDATA[Bayer sets up 500 LPM capacity oxygen plant in Odisha's Sambalpur district]]> https://biospectrumindia.com/news/95/21024/bayer-sets-up-500-lpm-capacity-oxygen-plant-in-odishas-sambalpur-district.html https://biospectrumindia.com/news/95/21024/bayer-sets-up-500-lpm-capacity-oxygen-plant-in-odishas-sambalpur-district.html Fri, 08 Apr 2022 18:20:00 +0530 Bayer has launched an oxygen plant with 500 LPM capacity, at SDH Rairakhol in Sambalpur district of Odisha, as part of its CSR initiative focusing on strengthening healthcare facilities in rural and underserved parts of India.     The plant has been set up with a capacity to supply up to 100 beds in the hospital and aims to fulfil the critical need for medical-grade oxygen in a hospital. The pressure swing absorption (PSA) Oxygen plant will generate, supply and store 93-95 per cent Pure Medical Oxygen for about 100 oxygenated beds.    Apart from the Sambalpur district of Odisha, Bayer is also setting up oxygen plants in the Raichur district of Karnataka, Tikamgarh in Madhya Pradesh, and Guwahati in Assam.   ]]> <![CDATA[Cadila Pharma launches novel three-dose rabies vaccine ThRabis]]> https://biospectrumindia.com/news/95/21022/cadila-pharma-launches-novel-three-dose-rabies-vaccine-thrabis.html https://biospectrumindia.com/news/95/21022/cadila-pharma-launches-novel-three-dose-rabies-vaccine-thrabis.html Fri, 08 Apr 2022 17:55:00 +0530 Ahmedabad-based Cadila Pharmaceuticals has developed a novel three-dose recombinant nano-particle based rabies G protein vaccine. A campaign has also been launched under the name ‘One, Two, Three. Rabies Free.’   The vaccine - ThRabis is prepared by using Virus-Like Particle technology (VLP). The VLPs self-assemble from this recombinant G protein which is produced from genes cloned into baculovirus expression vectors and expressed in Spodoptera frugiperda (Sf9) insect cells. The vaccine generates antibodies against rabies G protein, which leads to virus neutralisation, as well as prevents virus attachment to the cell to confer protection against rabies.   The ‘Cadila Against Rabies’ event held in Ahmedabad was attended by key experts from the Association for the Prevention and Control of Rabies in India (APCRI) Founder President and Mentor Dr MK Sudarshan; President Dr DH Ashwath Narayana; Secretary General Dr Sumit Poddar, and Treasurer Dr HS Ravish and other leading experts.   It is estimated that globally, rabies kills 59,000 animal bite victims every year, mainly in Asia and Africa. Over 20,000 people die in India alone, mainly because many animal bite victims do not complete the full course of the available vaccine. ]]> <![CDATA[Hester Biosciences to receive RS 60 Cr grant from BIRAC]]> https://biospectrumindia.com/news/95/21019/hester-biosciences-to-receive-rs-60-cr-grant-from-birac.html https://biospectrumindia.com/news/95/21019/hester-biosciences-to-receive-rs-60-cr-grant-from-birac.html Fri, 08 Apr 2022 17:15:00 +0530 Hester Biosciences to receive a grant of Rs 60 crores from BIRAC to support covid vaccine manufacturing under Mission Covid Suraksha. This information was given during the company's board meeting held recently.The grant will be allotted in a phased manner. ]]> <![CDATA[US-based Enveda Biosciences to open lead optimisation lab in Hyderabad]]> https://biospectrumindia.com/news/95/21026/us-based-enveda-biosciences-to-open-lead-optimisation-lab-in-hyderabad.html https://biospectrumindia.com/news/95/21026/us-based-enveda-biosciences-to-open-lead-optimisation-lab-in-hyderabad.html Fri, 08 Apr 2022 00:00:00 +0530 US-based Enveda Biosciences, a leading biotechnology company harnessing the power of nature’s chemistry, is opening a lead optimisation laboratory in Genome Valley, Hyderabad—the “Life Science Capital of India,” which is home to more than 200 life science and pharmaceutical companies including Novartis and Lonza. Enveda’s 24,000-square-foot space there will bolster the company’s growing workforce in India and enable it to more efficiently optimize lead compounds to identify clinical drug candidates. The Genome Valley laboratory will house imaging instruments, automated liquid handlers, and analysis software, among other state-of-the-art synthetic chemistry technologies used in the lead optimization cycle. The company expects to move into the new laboratory by the end of 2022. Enveda can expand its space in Hyderabad to accommodate nearly triple its current workforce. The company is also building out an advanced drug discovery and development center in the heart of Boulder, Colorado in the US. The 60,000-square-foot facility will significantly expand Enveda’s capacity to build a high-resolution chemical map of the natural world and identify new high-potential drug leads from it. ]]> <![CDATA[AstraZeneca India repositions Chennai-based Global Technology Centre]]> https://biospectrumindia.com/news/95/21014/astrazeneca-india-repositions-chennai-based-global-technology-centre.html https://biospectrumindia.com/news/95/21014/astrazeneca-india-repositions-chennai-based-global-technology-centre.html Thu, 07 Apr 2022 16:50:00 +0530 AstraZeneca India Private Limited (AZIPL) has repositioned its Global Technology Centre (GTC) to focus on driving increased innovation, resulting in a rebrand of the centre to Global Innovation and Technology Centre (GITC). The Chennai centre has played a key role in driving productivity, simplification, technology delivery and innovation across AstraZeneca’s business and supports life-changing medicines delivered to patients worldwide. The rebranding marks the centre’s evolution of capabilities, commitment to driving innovation and moving the company towards a digitally-enabled future. Cindy Hoots, Chief Digital Office and CIO, AstraZeneca, said, “Our centre in Chennai continues to play a strategic role in our digital transformation, working on visualisation, data and analytics, hyperautomation, XR/VR Capabilities, among other areas. These technologies and innovations play a key role in helping us to advance our science, anticipate patient needs, and work seamlessly across our organisation.” Siva Padmanabhan, MD, AZIPL, said, “With close to 2,800 highly skilled employees, GITC is now one of the largest technology centres across the Life Sciences industry in the country. The strong collaboration we have been able to build between industry, academia and the government has helped us in our pursuit of enabling smart capabilities at scale across the company’s value chain. Our GITC aims to bring the best of technology, innovation and people to the forefront, to address the ever-evolving healthcare and technology landscape." ]]> <![CDATA[Lupin acquires brands from AFDIL]]> https://biospectrumindia.com/news/95/21012/lupin-acquires-brands-from-afdil.html https://biospectrumindia.com/news/95/21012/lupin-acquires-brands-from-afdil.html Thu, 07 Apr 2022 12:00:00 +0530 Lupin announced the completion of a portfolio of brands from Anglo-French Drugs & Industries Limited (AFDIL) and its Associates.The acquisition will strengthen Lupin’s India Formulation business by adding a fast-growing portfolio of vitamins, minerals, supplements and neurological products. The acquisition of the AFDIL brands takes Lupin further in shaping its portfolio to emerge as a leading pharmaceutical company in India.“With this portfolio, Lupin will have a stronger market presence, providing healthcare professionals and patients with a more meaningful and comprehensive product offering,” said Nilesh Gupta, MD, Lupin.“We are confident in Lupin's ability to enhance the value of our portfolio of brands,” said Abhay Kanoria, CMD, AFDIL.Shailesh Gadre, Founder, GCV Life was the exclusive advisor for the transaction. ]]> <![CDATA[INCOR Health raises Rs 1550 M investment fund]]> https://biospectrumindia.com/news/95/21005/incor-health-raises-rs-1550-m-investment-fund.html https://biospectrumindia.com/news/95/21005/incor-health-raises-rs-1550-m-investment-fund.html Thu, 07 Apr 2022 07:55:00 +0530 INCOR Healthcare has raised financing of Rs 1550 million from Emerging India Credit Opportunities Fund I (EICOF I), an Investec managed SEBI registered Category II Alternate Investment Fund along with co-investment by Investec Bank.  The expansion plan for INCOR, under the brand OMNI Hospitals includes taking the bed count from 800+ to 1,500 – 2,000 beds (based on investment availability) over the next five to six years. There will also be a geographic expansion, from the current presence of two Indian states to five Indian states. INCOR will continue to exercise its expertise in acquiring and turning around sick hospitals into profitable centres. This growth will be supported and enabled with paperless technology environment support, and a patient engagement portal that will open up franchising opportunities enabling further growth. Dr Aloke Chandra Mullick, Group CEO, OMNI Hospital said, “There is renewed interest and growth momentum in this sector over the past two years. We plan to grow our asset base and financials, to be ready for a public listing in three years.” Ankit Shah, Group CFO, OMNI Hospital said, “This transaction closure has been the fastest for any institutional investor backed investment in INCOR, to closure timelines. The funding helps INCOR to firm up its consolidation strategy by giving an exit to its outgoing Private Equity investor, ASK Pravi." ]]> <![CDATA[ENTOD Pharma eyes skyrocket sales of Macushield tabs in 2022]]> https://biospectrumindia.com/news/95/21004/entod-pharma-eyes-skyrocket-sales-of-macushield-tabs-in-2022.html https://biospectrumindia.com/news/95/21004/entod-pharma-eyes-skyrocket-sales-of-macushield-tabs-in-2022.html Thu, 07 Apr 2022 07:50:00 +0530 ENTOD Pharmaceuticals is eyeing sales of more than half a million strips of Macushield tablets in 2022. Macushield tablets were developed by the research team of ENTOD Pharmaceuticals in early 2012, and since then have been available in both Indian and overseas markets.   "The product has seen exponential growth over the years both in the domestic and overseas international markets. We expect the sale of Macushield to skyrocket in 2022 owing to a growing awareness of eye health and preventable blindness in the public,” said Nikkhil K Masurkar, Executive Director, ENTOD Pharmaceuticals. ]]> <![CDATA[BSV acquires women's health brand from Jagdale Industries]]> https://biospectrumindia.com/news/95/20994/bsv-acquires-womens-health-brand-from-jagdale-industries.html https://biospectrumindia.com/news/95/20994/bsv-acquires-womens-health-brand-from-jagdale-industries.html Tue, 05 Apr 2022 15:05:00 +0530 Bharat Serums and Vaccines (BSV) has acquired Tidilan (Isoxsuprine hydrochloride), a leading brand in women’s health from Jagdale Industries, Bengaluru. Tidilan is currently available in tablet and injectable dosage forms. BSV has some of the leading women’s health brands such as Rhoclone, Hucog, Hucog 5000 HP, AntiD among others.    Tidilan (Isoxsuprine hydrochloride) is used for relaxing uterine muscles to prevent premature labour, among expecting mothers.    Sanjiv Navangul, MD and CEO, Bharat Serums & Vaccines, said, “This will be an important milestone towards our goal of being the top three women’s health players in India and as we continue to bring treatments and cures that help serve our patients better.”   Rajesh Jagdale, CMD, Jagdale Industries, added, “We are proud of our market-leading brand, Tidilan (Isoxsuprine hydrochloride) and are delighted with this partnership with BSV as we are confident that this will expand BSV’s offerings in women’s health as they work towards bringing more products that will improve lives of women in the country.”  ]]> <![CDATA[Lupin inks licensing agreement with Alvion for cardiometabolic drugs in SE Asia]]> https://biospectrumindia.com/news/95/20993/lupin-inks-licensing-agreement-with-alvion-for-cardiometabolic-drugs-in-se-asia.html https://biospectrumindia.com/news/95/20993/lupin-inks-licensing-agreement-with-alvion-for-cardiometabolic-drugs-in-se-asia.html Tue, 05 Apr 2022 14:55:00 +0530 Lupin has entered into a licensing agreement with Alvion Pharmaceuticals to commercialise medicines for cardiometabolic diseases in the South East Asia region. By commercialising cardiometabolic drugs in the South East Asian region, Lupin will play a significant role in improving the quality of healthcare and access to medicines. Gabriel Georgy, Regional Head South East Asia, Lupin said, “Forming a long-term collaboration with Alvion to launch a range of therapies will allow Lupin to expand its footprint across South East Asia with quality cost-effective alternatives for patients and the healthcare system. Both companies have a solid track record of developing and launching products and this agreement will further cement Lupin as a formidable pharmaceutical company in the region."John Bouros, CEO, Alvion said, “Being a leader in value-added medicines, Alvion shall support Lupin’s activities aiming to position both companies at the forefront for both molecules.” ]]> <![CDATA[Bharat Biotech slows down Covaxin production for facility optimisation]]> https://biospectrumindia.com/news/95/20991/bharat-biotech-slows-down-covaxin-production-for-facility-optimisation.html https://biospectrumindia.com/news/95/20991/bharat-biotech-slows-down-covaxin-production-for-facility-optimisation.html Sat, 02 Apr 2022 00:00:00 +0530 Bharat Biotech has announced the temporary slowing down of production of Covaxin across its manufacturing facilities, having completed its supply obligations to procurement agencies and foreseeing the decrease in demand. For the coming period, the company will focus on pending facility maintenance, process and facility optimization activities.As all existing facilities were repurposed for the manufacture of the vaccine, with continuous production during the past year, to meet the public health emergency of COVID-19, these upgrades were due.  During the recent WHO post EUL inspection, Bharat Biotech agreed with the WHO team on the scope of the planned improvement activities and indicated that they will be executed as soon as practical. This risk assessment by the WHO is based on the supply of hundreds of millions of doses of Covaxin globally, during which the product has demonstrated an excellent safety and efficacy profile in detailed and thorough post marketing surveillance activities. More than 1 million doses of COVAXIN were introduced under clinical trial mode, where safety of subjects was actively documented. Finally, Covaxin was extensively evaluated in ~30,000 subjects in more than 10 controlled clinical trials, resulting in more than 15 publications.  ]]> <![CDATA[Dr. Reddy's announces introduction of medical cannabis products in Germany]]> https://biospectrumindia.com/news/95/20992/dr-reddys-announces-introduction-of-medical-cannabis-products-in-germany.html https://biospectrumindia.com/news/95/20992/dr-reddys-announces-introduction-of-medical-cannabis-products-in-germany.html Sat, 02 Apr 2022 00:00:00 +0530 Hyderabad-based Dr. Reddy's Laboratories and MediCane Health Inc. have announced the launch of their therapeutic cannabis product in Germany. Under a collaboration between Dr. Reddy's and MediCane that began in 2021, MediCane will supply medical cannabis products to Dr. Reddy's from its EU GMP-certified facilities based in Portugal, while providing logistical and regulatory support.  As the exclusive distributor of the products in Germany, Dr. Reddy's will provide access to medicinal cannabis products, from MediCane, under its own brand, with the support of a field team, specialized and able to provide healthcare professionals training on the use of the products as well as advice on the process of reimbursement by health insurance. This launch marks MediCane's entry into the pharmaceutical sector of a major European market. For Dr. Reddy's, this launch strengthens its presence in the growing German medical cannabis market, a presence already strengthened since the company's recent acquisition of Nimbus Health GmbH, specializing in the distribution, registration, sale and the commercialization of therapeutic cannabis. Dr. Reddy's and MediCane have also signed an agreement to co-fund a Phase II clinical trial of a cannabis-based product for the relief of behavioral and psychological symptoms of dementia (BPSD). Upon completion of this trial, Dr. Reddy's will have exclusive rights to sell and market said product in Europe (excluding Russia and CIS countries). The parties plan to start the clinical trial of the product in the second half of 2022. BPSD refers to the spectrum of non-cognitive and non-neurological symptoms commonly seen in dementia, such as agitation, aggression, psychosis, depression and apathy. ]]> <![CDATA[Bayer to unveil 27 telemedicine centres across eight states]]> https://biospectrumindia.com/news/95/20985/bayer-to-unveil-27-telemedicine-centres-across-eight-states.html https://biospectrumindia.com/news/95/20985/bayer-to-unveil-27-telemedicine-centres-across-eight-states.html Fri, 01 Apr 2022 11:55:00 +0530 Bayer will set up 27 telemedicine centres in 12 districts across eight states in India over the next two years, through Bayer Foundation India. The centres will be set up in partnership with RxDx Healthcare and Piramal Swasthya, the public health arm of Piramal Foundation.The key objectives of this endeavour are to establish a telehealth facility in the identified states of Bihar, Chhattisgarh, Jharkhand, Karnataka, Gujarat, Uttar Pradesh, Maharashtra, and Madhya Pradesh to provide complete healthcare solutions via telehealth and conduct training and awareness sessions on health, hygiene and nutrition. In addition, medical camps will be conducted at regular intervals to create awareness on specific health aspects like breast cancer, diabetes, dermatology. ]]> <![CDATA[Sun Pharma to introduce version of antidepressant Vortioxetine in India]]> https://biospectrumindia.com/news/95/20970/sun-pharma-to-introduce-version-of-antidepressant-vortioxetine-in-india.html https://biospectrumindia.com/news/95/20970/sun-pharma-to-introduce-version-of-antidepressant-vortioxetine-in-india.html Wed, 30 Mar 2022 15:40:00 +0530 Sun Pharmaceutical Industries has announced that one of its wholly-owned subsidiaries has entered into an exclusive patent licensing agreement with Denmark-based H Lundbeck (Lundbeck) to market and distribute its version of Vortioxetine in India under the brand name, VORTIDIF. The territory of the licensing agreement will only cover India.   Vortioxetine is a novel antidepressant with multimodal activity, which is approved to treat Major Depressive Disorder (MDD) in adults. The product is approved in over 80 countries, including the US, the EU, Canada and Australia.   MDD is one of the leading cause of disability, affecting approximately 246 million people globally and 35 million people in India. MDD is characterised by pronounced changes in mood coupled with distinct psychological and vegetative changes, including sleep, appetite disturbance, subjective fatigue, loss of motivation and drive, ruminative feelings of guilt and despair, problems maintaining mental focus, and suicidal thinking and behaviour.   ]]> <![CDATA[Aurobindo Pharma buys domestic formulations biz of Veritaz Healthcare]]> https://biospectrumindia.com/news/95/20958/aurobindo-pharma-buys-domestic-formulations-biz-of-veritaz-healthcare.html https://biospectrumindia.com/news/95/20958/aurobindo-pharma-buys-domestic-formulations-biz-of-veritaz-healthcare.html Tue, 29 Mar 2022 08:00:00 +0530 Aurobindo announced the acquisition of the domestic formulation business of Veritaz on a slump sale basis. With this acquisition, Aurobindo is marked its first step to set its footprint in the Indian domestic market as announced earlier. The transaction is agreed upon at a consideration of Rs 171 crore on a debt-free cash-free basis.  The transaction comes into effect on April 1, 2022, and is expected to close by May 2022. This acquisition vehicle will greatly help Aurobindo as a launchpad for marketing biosimilar and other products in India.K Nithyananda Reddy, MD, Aurobindo Pharma said: “I am pleased to announce Aurobindo’s entry into the domestic market with this acquisition; with this acquisition, we strongly believe that with Aurobindo’s ability to build a product portfolio, and with the existing and expanding distribution network of Veritaz we will be able to create a significant footprint in the domestic pharma market over the next few years." ]]> <![CDATA[The Best Laboratory opens centre in Coimbatore]]> https://biospectrumindia.com/news/95/20934/the-best-laboratory-opens-centre-in-coimbatore.html https://biospectrumindia.com/news/95/20934/the-best-laboratory-opens-centre-in-coimbatore.html Thu, 24 Mar 2022 16:40:00 +0530 The Best Laboratory has launched its new state-of-the-art laboratory at Ramanathapuram, Coimbatore. The Best Laboratory has two branches in Sulur and Sivananda Colony in the city. The new laboratory is spread over 2400 square feet.   Prof Dr A Nirmala, MS (GS), DGO, Dean, Coimbatore Medical College & Hospital participated as chief guest and Prof Dr VG Mohan Prasad, MD (DM), Chairman, VGM Hospitals, KP Ramaswamy, Chairman, KPR Group of companies, J Meena Jayakumar, Chairman, Aalam Vizhuthakal and Vishnu Vittal, Executive Director, Grand World Elder Care participated as guest of honour in the launching ceremony.   The laboratory will offer clinical pathology, biochemistry, immunology, serology, histopathology, cytology and microbiology testing services. Booking of the tests can be done through our website and WhatsApp. A wide range of health checkups including preventive checkups for all age groups, disease-specific comprehensive test packages and master health checkups are available to ensure the health needs of everyone is met.  ]]> <![CDATA[Wockhardt, Serum Institute of India to manufacture multiple vaccines in UK]]> https://biospectrumindia.com/news/95/20916/wockhardt-serum-institute-of-india-to-manufacture-multiple-vaccines-in-uk.html https://biospectrumindia.com/news/95/20916/wockhardt-serum-institute-of-india-to-manufacture-multiple-vaccines-in-uk.html Mon, 21 Mar 2022 00:00:00 +0530 Wockhardt has announced a collaboration with Serum Life Sciences UK Ltd, a subsidiary of the Serum Institute of India, to deliver a global vaccine programme. This collaboration between a subsidiary of Wockhardt and Serum Life Sciences UK will help create considerable number of employment opportunities along with creation of new sterile fill and finish facility in Wrexham, North Wales. A profit sharing arrangement has been made between the two parties for this New Facility that will deliver an additional 150 million vaccine doses of multiple vaccines. Natasha Poonawalla, Chairperson, Serum Life Sciences, added “The collaboration will be instrumental in building long-term capacity in the UK. With this, we seek to further bolster supply resilience and support the global rollout of vaccines.” Wockhardt UK has manufactured a COVID-19 vaccine in collaboration with UK Government and AstraZeneca. Its collaboration with Serum Life Sciences is an addition to the earlier arrangement. ]]> <![CDATA[Akston Biosciences, Biolexis bring room-temperature stable COVID-19 vaccine]]> https://biospectrumindia.com/news/95/20910/akston-biosciences-biolexis-bring-room-temperature-stable-covid-19-vaccine.html https://biospectrumindia.com/news/95/20910/akston-biosciences-biolexis-bring-room-temperature-stable-covid-19-vaccine.html Fri, 18 Mar 2022 00:00:00 +0530 Akston Biosciences Corporation and Biolexis, a division of Stelis Biopharma have entered into a licensing, manufacturing and commercialization agreement for Akston’s AKS-452, a protein subunit COVID-19 vaccine. Under the agreement, Biolexis gains the right to manufacture and commercialize AKS-452 (branded as AmbiVax-CTM) in India and over 130 countries in Asia, Latin America, and Africa largely covering the low-and-middle-income countries (LMICs). Biolexis will also leverage the capabilities of Strides Group for launching this vaccine across regions where the group has a deep market presence and established relationships. AKS-452 or AmbiVax-CTM is a first-of-its-kind thermostable COVID-19 vaccine developed for all parts of the world. AmbiVax-CTM is a SARS-CoV-2 protein subunit vaccine designed to induce a Th1/Th2 mixed immune response in patients against the Receptor Binding Domain (RBD) of the novel coronavirus spike protein. The stability studies conducted on AmbiVax-CTM have demonstrated thermostability at room temperature for over six months at 25° Celsius (77° Fahrenheit) and maintains potency for one month at 37° Celsius (99° Fahrenheit).  ]]> <![CDATA[US-based Exergen Medical expands presence in India]]> https://biospectrumindia.com/news/95/20894/us-based-exergen-medical-expands-presence-in-india.html https://biospectrumindia.com/news/95/20894/us-based-exergen-medical-expands-presence-in-india.html Wed, 16 Mar 2022 00:00:00 +0530 Exergen Corporation, US-based player in infrared temperature measurement for medical applications, has signed a distributor agreement with Ababil Healthcare. Based in Chennai, Ababil Healthcare aims to provide high-quality healthcare services and products in 6 Indian states, home to around 275 million people.  The TAT-5000 and the TAT-2000 thermometers for professional use by doctors and nurses and the TAT-2000C thermometer for consumer applications are based on a very innovative infrared technology. They offer many advantages over more traditional methods of determining a patient's body temperature. “Ababil Healthcare delivers state-of-the-art medical equipment for doctors, nursing homes, and hospitals to manage every critical care department. We are very impressed by the accuracy and ease of use of the Temporal Artery Thermometer”, says Mohammed Ibrahim, CEO of Ababil Healthcare. “At the same time the infrared thermometers designed and manufactured by Exergen are very affordable. We think both doctors, nurses and at-home-users in India will love the Temporal Artery Thermometer series of products”.  ]]> <![CDATA[Bharat Biotech, Biofabri to develop, manufacture and distribute novel TB vaccine, MTBVAC]]> https://biospectrumindia.com/news/95/20898/bharat-biotech-biofabri-to-develop-manufacture-and-distribute-novel-tb-vaccine-mtbvac.html https://biospectrumindia.com/news/95/20898/bharat-biotech-biofabri-to-develop-manufacture-and-distribute-novel-tb-vaccine-mtbvac.html Wed, 16 Mar 2022 00:00:00 +0530 Hyderabad-based Bharat Biotech has announced the partnership with Biofabri, a Spanish biopharmaceutical company, to join forces to develop, manufacture and market a new tuberculosis vaccine in more than 70 countries in Southeast Asia and sub-Saharan Africa. The vaccine is being manufactured and developed by Biofabri, in close collaboration with the University of Zaragoza, IAVI and the Tuberculosis Vaccine Initiative (TBVI). MTBVAC has been designed and discovered by Carlos Martín team of the University of Zaragoza. This agreement between Bharat Biotech and Biofabri would guarantee the worldwide production and the supply of the future vaccine in more than 70 countries with a high TB incidence, such as India which has the highest TB burden in the world, with a 25% of all cases. MTBVAC is one of the most promising vaccine candidates in the current global TB vaccine pipeline. The only currently available TB vaccine, the Bacillus Calmette-Guérin vaccine (BCG), was developed 100 years ago and has limited efficacy in preventing pulmonary TB in adults, who, along with adolescents, are the biggest spreaders of the disease. "Bharat Biotech has opted for this vaccine candidate owing to its advanced stage of clinical development as well as the extremely promising results from Phase 1 and Phase 2 clinical trials." said Dr. Krishna Ella, Chairman and Managing Director Bharat Biotech. ]]> <![CDATA[Karam Safety diversifies healthcare range with launch of K-air face masks for children]]> https://biospectrumindia.com/news/95/20883/karam-safety-diversifies-healthcare-range-with-launch-of-k-air-face-masks-for-children.html https://biospectrumindia.com/news/95/20883/karam-safety-diversifies-healthcare-range-with-launch-of-k-air-face-masks-for-children.html Mon, 14 Mar 2022 00:00:00 +0530 Karam Safety , a leading manufacturer and marketer of Personal Protective Equipment (PPE), has launched Karam Healthcare (K-air) Face Masks for children. These new kid-sized masks are available in exclusive designs and will help parents prepare for their young ones to participate in outdoor activities, especially since they will be heading back to school.  Designed for children between the age group of 4-12 years, the all-new K-air FFP2 SL D Respirators offer maximum coverage over the mouth and nose of the child. The FFP2 SL D Respirators for kids come after Karam’s diversification into the Karam Healthcare range earlier last year. The brand also manufactures FFP2 ‘Disposable Face Masks Range’ that offers uncompromised protection against viruses, bacterial microorganisms, dust, pollen, smoke and provides easy breathability. The brand also has surgical masks and surgical tie back masks in its range to filter air contaminants, bacterial microorganisms, dust, pollen and smoke. ]]> <![CDATA[DoP announces guidelines for 'Strengthening of Pharma Industry' scheme]]> https://biospectrumindia.com/news/95/20879/dop-announces-guidelines-for-strengthening-of-pharma-industry-scheme.html https://biospectrumindia.com/news/95/20879/dop-announces-guidelines-for-strengthening-of-pharma-industry-scheme.html Fri, 11 Mar 2022 00:00:00 +0530 Department of Pharmaceuticals (DoP), Ministry of Chemicals and Fertilizers has released the guidelines for the scheme “Strengthening of Pharmaceutical Industry", with a total financial outlay of Rs 500 crore for the period from FY 21-22 to FY 25-26. The scheme will address the rising demand in terms of support required to existing Pharma clusters and MSMEs across the country to improve their productivity, quality and sustainability  The objectives of the scheme are to strengthen the existing infrastructure facilities in order to make India a global leader in the Pharma Sector. Under the Scheme, financial assistance to pharma clusters will be provided for creation of Common Facilities. This will not only improve the quality but also ensure the sustainable growth of clusters. Further, in order to upgrade the production facilities of SMEs and MSMEs so as to meet national and international regulatory standards (WHO-GMP or Schedule-M), interest subvention or capital subsidy on their capital loans will be provided, which will further facilitate the growth in volumes as well as in quality. It is expected that the units supported under this scheme will act as Demonstration Firms for the pharma clusters and MSE Pharma Industries, to develop on quality and technology upgradation fronts. ]]> <![CDATA[Thyrocare to open labs in Jaipur and Visakhapatnam]]> https://biospectrumindia.com/news/95/20868/thyrocare-to-open-labs-in-jaipur-and-visakhapatnam.html https://biospectrumindia.com/news/95/20868/thyrocare-to-open-labs-in-jaipur-and-visakhapatnam.html Thu, 10 Mar 2022 14:00:00 +0530 With 4 Regional Processing Labs operational in the current quarter, in Nagpur, Ranchi, Raipur and Ahmedabad, Thyrocare is all set to launch 2 Regional Processing Labs in Jaipur and Vizag, in March 2022.   Thyrocare is gearing up for launch in Jaipur in the second week and Visakhapatnam in the fourth week of March.   As per standard protocol, Thyrocare’s existing Regional Processing Labs (RPLs), as well as the upcoming ones, will have automated technologies such as Photometry, Hematology, Immunoassay and HPLC along with manual Urology and ELISA.    Thyrocare Technologies has a 27-year-old fully operational Centralised Processing Laboratory (CPL) in Navi Mumbai. It also has three functional Zonal Processing Laboratories (ZPL) in Bengaluru, Delhi, Kolkata and four specially designated COVID-19 Processing laboratories in cities such as Bengaluru, Delhi, Kolkata and Mumbai.     ]]> <![CDATA[Indian Society of Nephrology, AstraZeneca India announce multi-year partnership]]> https://biospectrumindia.com/news/95/20860/indian-society-of-nephrology-astrazeneca-india-announce-multi-year-partnership.html https://biospectrumindia.com/news/95/20860/indian-society-of-nephrology-astrazeneca-india-announce-multi-year-partnership.html Wed, 09 Mar 2022 13:25:00 +0530 Indian Society of Nephrology (ISN) and AstraZeneca have announced a multi-year partnership to create public awareness about kidney care and related health disorders, build education at the primary care physician-level on early diagnosis, prompt management and aid nationwide screening for at-risk patients and the general public to promote timely detection and holistic management.AstraZeneca under close guidance from ISN will facilitate ‘Project SEARCH’ - a mass screening programme for early diagnosis of CKD in diabetic or hypertensive patients who are at high risk of kidney damage. A campaign will be conducted at over 2000 physician clinics over one month at multiple locations across the country and is expected to reach out to 2.4 lakh patients. The society has nominated top nephrologists of the country as regional coordinators to provide the requisite scientific support and mentorship to participating physicians ISN will also spearhead the analysis of the collected data that can be used to change the practice and influence policymakers. The partnership will also focus upon undertaking certificate programmes by the country’s top 30 nephrologists for about 1000 primary care physicians through three interactive modules. ]]> <![CDATA[Sentynl Therapeutics, BridgeBio Pharma in asset purchase agreement for NULIBRY]]> https://biospectrumindia.com/news/95/20858/sentynl-therapeutics-bridgebio-pharma-in-asset-purchase-agreement-for-nulibry.html https://biospectrumindia.com/news/95/20858/sentynl-therapeutics-bridgebio-pharma-in-asset-purchase-agreement-for-nulibry.html Wed, 09 Mar 2022 07:30:00 +0530 Sentynl Therapeutics, a US-based biopharmaceutical company and a wholly-owned subsidiary of Zydus Lifesciences announced the execution of an asset purchase agreement for the sale of BridgeBio’s NULIBRY (Fosdenopterin) for injection. NULIBRY is approved by the USFDA to reduce the risk of mortality in patients with molybdenum cofactor deficiency (MoCD) Type-A, an ultra-rare, life-threatening paediatric genetic disorder. The company’s wholly-owned subsidiary Sentynl is also facilitating early diagnosis and treatment by enhancing awareness, new-born screening, genetic testing and patient support across multiple products and rare diseases including the development of a treatment for Menkes Disease, currently under rolling review by the USFDA, for which it partnered with Cyprium Therapeutics, (Cyprium). Under the terms of the agreement, Sentynl will acquire global rights to NULIBRY and will be responsible for the ongoing development and commercialisation of NULIBRY in the US and developing, manufacturing and commercialising Fosdenopterin globally. BridgeBio will share development responsibilities for Fosdenopterin through approval of the marketing authorisation application already under accelerated assessment with the European Medicines Agency and through approval of its regulatory submission with the Israeli Ministry of Health. Sentynl will provide cash payments upon the achievement of certain regulatory milestones. BridgeBio will be eligible to receive commercial milestone payments as well as tiered royalties on adjusted net sales of NULIBRY. ]]> <![CDATA[Ankura launches pharma data integrity solution]]> https://biospectrumindia.com/news/95/20851/ankura-launches-pharma-data-integrity-solution.html https://biospectrumindia.com/news/95/20851/ankura-launches-pharma-data-integrity-solution.html Tue, 08 Mar 2022 14:00:00 +0530 Advisory firm Ankura Consulting has announced the expansion of its pharmaceutical and biopharma regulatory compliance offering with the addition of a Pharmaceutical Data Integrity solution within the data and technology practice, bolstering its comprehensive client advisory capabilities.   The offering includes an Early Warning System (EWS), an automated platform to help identify data integrity anomalies in real-time and assist companies in performing forensic data integrity investigations and remediation for any regulatory action such as form 483, warning letter, an import alert.    The EWS solution also solves the challenge of integrating multiple quality systems (such as CDS, NON CDS and LIMS) into one platform, enabling the quality control department to take advantage of the integrated monitoring capabilities and providing alerts for any non-compliant activities. It also provides the flexibility to customise and deploy the solution to an on-premises environment and customise the workflows and analytics models for each organisation. ]]> <![CDATA[HDFC Bank, Wipro GE Healthcare, United Way Delhi to train 6900 Goa youth]]> https://biospectrumindia.com/news/95/20842/hdfc-bank-wipro-ge-healthcare-united-way-delhi-to-train-6900-goa-youth.html https://biospectrumindia.com/news/95/20842/hdfc-bank-wipro-ge-healthcare-united-way-delhi-to-train-6900-goa-youth.html Tue, 08 Mar 2022 09:25:00 +0530 HDFC Bank, under its flagship CSR programme Parivartan, launched a skill training initiative for 6,900 youth in Goa in collaboration with Wipro GE Healthcare and United Way Delhi (UWD). Beneficiaries associated with skilling institutes will be imparted training for various non-technical job roles in the healthcare sector. Apart from training, the students will be provided assistance in job placements. The initiative aims at reducing the supply gap of trained manpower in the existing healthcare system and strengthening the nation's healthcare workforce. Nationally, this initiative will train and provide employment to youth over the span of two years across 13 states of India.   The initiative was officially launched at the Old Asilo Centre in Mapusa, Goa by Ashish Jain, CEO, Healthcare Sector Skill Council and Deepali Nayak, Director- Directorate of Women and Child Development and Directorate of Entrepreneurship and Skill Development.   The 6,900 beneficiaries will be imparted skill-based training for job roles in GDA advance, phlebotomy technician and hospital front desk coordinator. Apart from training, the students will also get placement support for jobs in the healthcare sector. This would provide a trained healthcare workforce and reduce the prominent patient-to-attendee gap.    ]]> <![CDATA[Metropolis Healthcare opens centre in Baner, Pune]]> https://biospectrumindia.com/news/95/20837/metropolis-healthcare-opens-centre-in-baner-pune.html https://biospectrumindia.com/news/95/20837/metropolis-healthcare-opens-centre-in-baner-pune.html Mon, 07 Mar 2022 15:00:00 +0530 Metropolis Healthcare has launched an advanced diagnostic testing centre in Baner, Pune. The 1500 sq ft laboratory can conduct around 500 sample testing per month with a quick turnaround time and high-quality reports. Dr Sushil Shah, Founder & Chairman, Metropolis Healthcare Ltd., graced the occasion as the Chief Guest.    Metropolis Laboratory, Baner will offer different tests ranging from basic day to day pathology tests to high-end molecular diagnostics tests at reasonable rates. It is known for numerous quality accreditations to its credit, both in India and abroad and with decades of experience under the hat, Metropolis has conscientiously developed the Indian Reference Range for an extensive test menu, which is now being used by thousands of laboratories across the country.     ]]> <![CDATA[Zydus bags DCGI approval for 'anaemia associated with CKD' drug Oxemia ]]> https://biospectrumindia.com/news/95/20830/zydus-bags-dcgi-approval-for-anaemia-associated-with-ckd-drug-oxemia-.html https://biospectrumindia.com/news/95/20830/zydus-bags-dcgi-approval-for-anaemia-associated-with-ckd-drug-oxemia-.html Mon, 07 Mar 2022 13:15:00 +0530 Zydus Lifesciences has received approval for its New Drug Application (NDA) from the Drug Controller General of India for Oxemia (Desidustat), a first-of-its-kind oral treatment in India for anaemia associated with Chronic Kidney Disease (CKD).   Oxemia is an oral, small molecule hypoxia-inducible factor-prolyl hydroxylase (HIF-PH) inhibitor. Desidustat met its primary endpoints for haemoglobin improvement in the DREAM- D and DREAM-ND Phase III clinical trials and showed a good safety profile, downregulation of hepcidin, improved iron mobilisation and LDL-C reduction in CKD patients.   The clinical development programme of Desidustat was one of the largest trials of its kind in India for anemia in CKD patients, conducted in over 1200 subjects. Desidustat provides CKD patients with an oral convenient therapeutic option for the treatment of anaemia. ]]> <![CDATA[Germany-based Ever Pharma launches apomorphine therapy devices to treat Parkinson's in India]]> https://biospectrumindia.com/news/95/20827/germany-based-ever-pharma-launches-apomorphine-therapy-devices-to-treat-parkinsons-in-india.html https://biospectrumindia.com/news/95/20827/germany-based-ever-pharma-launches-apomorphine-therapy-devices-to-treat-parkinsons-in-india.html Sat, 05 Mar 2022 00:00:00 +0530 In a boon to patients suffering from Parkinson’s Disease, advanced third-generation D-mine apomorphine pumps and pens (injections) manufactured by German pharma major Ever Pharma was recently launched by Celera Neuro Sciences in Bengaluru. The state-of-the-art apomorphine-delivery devices, widely used in Europe, were unveiled by Dr K Sudhakar, Minister of Medical Education & Health, Govt of Karnataka, at a symposium on Parkinson's Disease in Bengaluru, organised by King's College London (KCL) and Parkinson's Research Alliance of India (PRAI).The third-generation D-mine apomorphine pumps, widely used in Europe, can be self-handled by patients in five easy steps, with much less patient training needed. The pump-filling process is controlled electronically, with much higher safety and convenience, compared to pumps which are operated manually, with cumbersome procedures. D-mine pumps are pre-filled and offer a continuous infusion of apomorphine, leading to absorption within five minutes. The oral pill burden of patients also comes down substantially. ]]> <![CDATA[B Medical Systems’ U201 receives WHO PQS prequalification for ultra-low freezers ]]> https://biospectrumindia.com/news/95/20813/b-medical-systems-u201-receives-who-pqs-prequalification-for-ultra-low-freezers-.html https://biospectrumindia.com/news/95/20813/b-medical-systems-u201-receives-who-pqs-prequalification-for-ultra-low-freezers-.html Thu, 03 Mar 2022 15:35:00 +0530 B Medical Systems has announced that the company’s Ultra-Low Freezer U201 has received the WHO PQS prequalification. This is the first-ever Ultra-Low Freezer in the world to receive the WHO PQS prequalification.     The U201 has a gross storage volume of 214L and provides a storage temperature varying from -86°C to -20°C. Designed with state-of-the-art refrigeration technology, the product offers superior temperature uniformity and holdover time. U201 uses a green refrigerant that has minimal impact on the environment and is compliant with the US SNAP and EU F-Gas regulations. The unit offers advanced inbuilt alarm systems and provides 24/7 real-time monitoring solutions via the company’s Real-Time Monitoring Devices (RTMD) and °B Connected solutions. The password-protected/NFC-based locking mechanism further prevents unauthorised access to the specimens. The product is certified to operate at ambient temperature as high as +43°C and is an ideal solution for last-mile vaccination campaigns, doctor’s clinics, hospitals, etc. The U201 is also a class II(a)/II certified medical device as per EU MDR and US FDA regulation.    ]]> <![CDATA[Mapmygenome India opens Genomics Experience Centre in Bengaluru]]> https://biospectrumindia.com/news/95/20806/mapmygenome-india-opens-genomics-experience-centre-in-bengaluru.html https://biospectrumindia.com/news/95/20806/mapmygenome-india-opens-genomics-experience-centre-in-bengaluru.html Thu, 03 Mar 2022 00:00:00 +0530 Mapmygenome India has opened its Genomics Experience Centre in Bengaluru. The NABL & ICMR-certified centre is located at Sector 7, HSR Layout. The new centre is an expansion of Mapmygenome's services provided in Hyderabad and Delhi. Dr CN Ashwath Narayan, Minister of Information Technology and Biotechnology inaugurated the centre. Dr Kiran Mazumdar-Shaw, Chairperson of Biocon and Biocon Biologics, was the guest of honour.Dr Mazumdar-Shaw said, "With this backdrop, it is great to have a company like Mapmygenome expanding their services to preventive genomics that combines genomic sequencing and biochemistry."Anu Acharya, CEO, Mapmygenome, said, "We are calling this a genomics experience centre as we will combine genomics with lifestyle and preventive biochemistry. We also have nutrition, medical and genetic counselling for our customers." ]]> <![CDATA[US brand 7e Wellness launches device for anti-ageing treatment in India]]> https://biospectrumindia.com/news/95/20804/us-brand-7e-wellness-launches-device-for-anti-ageing-treatment-in-india.html https://biospectrumindia.com/news/95/20804/us-brand-7e-wellness-launches-device-for-anti-ageing-treatment-in-india.html Wed, 02 Mar 2022 16:30:00 +0530 San Diego headquartered 7e Wellness has forayed into the Indian market. The brand has recently launched MyoLift Mini Microcurrent Device that is set to pave the way for non-invasive microcurrent technology-powered anti-ageing facials.    The device priced at Rs 22,999 comes with a set of 2 probes that can be manoeuvred on the face for targeted treatment. Known for its ability to boost ATP, collagen and elastin production, Myolift Mini can be used up to three times a week for effortless skin-lifting results.   It also includes conductive masks to target the eye, lip and forehead areas along with a ReStore Conductive Gel that must be applied before the treatment.   ]]> <![CDATA[SRT partners with Boston Micro Fabrication for precision micro 3D printing]]> https://biospectrumindia.com/news/95/20793/srt-partners-with-boston-micro-fabrication-for-precision-micro-3d-printing.html https://biospectrumindia.com/news/95/20793/srt-partners-with-boston-micro-fabrication-for-precision-micro-3d-printing.html Tue, 01 Mar 2022 14:50:00 +0530 Boston Micro Fabrication (BMF), USA has partnered with Mumbai-based Shree Rapid Technologies (SRT) and marks the entry of BMF2 micron series, 10-micron series and 25-micron series 3D Printers in India.   With Micro 3D Printing applications spread across a wide variety of industries, the BMF printers, having the combination of ultra-high resolution, accuracy, and precision allow for more intricate, exact, and replicable parts.    With the ability to reach resolutions as low as 2 microns, industries such as medical, electronics, microfluidics will be further benefited by being able to print stents to prosthetics to surgical planning, electrical components, connectors and tools like Lab-on-Chip and other devices.    ]]> <![CDATA[Briota Technologies to receive OPPI's Start-up of the Year 2021 Award]]> https://biospectrumindia.com/news/95/20792/briota-technologies-to-receive-oppis-start-up-of-the-year-2021-award.html https://biospectrumindia.com/news/95/20792/briota-technologies-to-receive-oppis-start-up-of-the-year-2021-award.html Tue, 01 Mar 2022 08:45:00 +0530 The Organisation of Pharmaceutical Producers of India (OPPI) announced the winner of Excellence in Innovation Healthcare Start-up of the Year 2021 Award. Briota Technologies, a digital health and wellness company, innovating for remote care, diagnostics and management of chronic respiratory conditions, has been conferred the award for developing a novel concept of AI-powered SpiroPROTM Device for screening and diagnosis of chronic respiratory ailments.Briota Technologies has developed a novel concept of AI-powered SpiroPROTM Device for screening and diagnosis of chronic respiratory ailments.As a part of the award, the winner will receive a yearlong mentorship from Bayer Pharmaceuticals in addition to a grant-in-aid of Rs 1,00,000 and a certificate of citation.The award will be conferred at the upcoming Annual Summit of OPPI on March 23, 2022. ]]> <![CDATA[Kolkata-based TABLT Pharmacy raises $1.5 million]]> https://biospectrumindia.com/news/95/20788/kolkata-based-tablt-pharmacy-raises-1-5-million.html https://biospectrumindia.com/news/95/20788/kolkata-based-tablt-pharmacy-raises-1-5-million.html Mon, 28 Feb 2022 15:10:00 +0530 Kolkata-based TABLT Pharmacy has raised $1.5 million in pre-series A round. Tablt pharmacy deals in medicines, OTCs, and other healthcare products.Sunil Singhvi, Vice Chairman, JITO says, “Presently serving four states, Tablt aspires to be in 10+ states in the next two years. We at JITO Angel Network, believe that Tablt will capture a major share in the coming years. We have backed Tablt since their inception and have confidence that Tablt will be a market leader in the Bharat market.”The company plans to open 500 new franchisees thus creating a network of more than 1000 franchisees in the current year – 2022. Funds will be deployed to build teams across Tech, Product & Marketing functions. Besides, it has plans to open ‘Fulfilment Centres’ in Bhubaneswar, Patna and Siliguri. ]]> <![CDATA[BDR Pharma unveils prostate cancer drug BDENZA in 160 mg capacity]]> https://biospectrumindia.com/news/95/20787/bdr-pharma-unveils-prostate-cancer-drug-bdenza-in-160-mg-capacity.html https://biospectrumindia.com/news/95/20787/bdr-pharma-unveils-prostate-cancer-drug-bdenza-in-160-mg-capacity.html Mon, 28 Feb 2022 14:25:00 +0530 BDR Pharmaceuticals has launched BDENZA in 160 mg strength aiding the convenience of prostate cancer patients. The medicine was previously available in 40 mg and 80 mg strength for which patients had to consume 2 tablets a day as per approved dosage is primarily used to treat prostate cancer patients.   The objective behind the launch of Enzalutamide 160mg is to ensure better efficacy, minimum side effects, contain relapse cases by blocking the hormones of cancer cells providing an evolved treatment.    Patients will now have to consume only one tablet a day making it patient compliant, thereby reducing the associated stress of an already stressed out cancer patient.   Raheel Shah, Director Business Development from BDR Pharmaceuticals Int’l, Mumbai said, “Our focused launch of such expanded brand strength will definitely add value to Indian Oncology patients as well as provide opportunity for Medical Physicians to comply with patient outcome and standard treatment protocol. This represents firm commitment to providing access to affordable medicines for Indian cancer patients with high a quality standard”.   ]]> <![CDATA[Medulance to expand in-house team, leadership role]]> https://biospectrumindia.com/news/95/20772/medulance-to-expand-in-house-team-leadership-role.html https://biospectrumindia.com/news/95/20772/medulance-to-expand-in-house-team-leadership-role.html Fri, 25 Feb 2022 17:15:00 +0530 Medulance plans to recruit for business development and client servicing team. The company is also seeking to bolster its business and technology vertical by onboarding chief marketing officer, chief business officer, chief technology officer, regional and city managers.   Currently, the company has a team of 60 employees and eyes to scale its presence across India by setting up city-wise verticals. Looking for the best talent, Medulance follows a two-fold screening process. First, the resumes are shortlisted based on an ATS-enabled screening. After that, they conduct a screening call to understand the candidate’s expectations, personality, and suitability for the job role.   Welcoming job seekers across the country, the company follows a multi-level interview process. The initial screening takes around five to seven days, followed by a three-round weekly interview for shortlisted candidates. The final selection round for the Business Development Team and the Client Servicing Team is conducted by the co-founder, Pranav Bajaj and for the candidates applying for the positions in the Technology team, the final round is conducted by the co-founder, Ravjot Singh.  ]]> <![CDATA[Zydus unveils innovation-centric brand identity]]> https://biospectrumindia.com/news/95/20742/zydus-unveils-innovation-centric-brand-identity.html https://biospectrumindia.com/news/95/20742/zydus-unveils-innovation-centric-brand-identity.html Thu, 24 Feb 2022 16:55:00 +0530 The Zydus group announced its new brand identity with the listed entity of the group Cadila Healthcare to be known as Zydus Lifesciences. The company’s new brand identity brings together two hearts in purple and teal colours symbolising its commitment to science and innovation along with care and nurturance. In the new logo, two hearts come together to enclose ‘us’ at the core. The heart represents the company’s inclusiveness. The Teal and Purple colours represent the pillars of science and care. While the dynamic teal expresses Zydus’ dynamism and stands for the company’s commitment to science, the purposeful purple stands for dedication to care and nurturance. The ‘us’ in the new Zydus logo represents all the stakeholders including employees, patients, doctors, investors, bankers, business partners, associates and all those who are an integral part of Zydus’ journey. ]]> <![CDATA[Metropolis Healthcare opens centre in Nanded]]> https://biospectrumindia.com/news/95/20737/metropolis-healthcare-opens-centre-in-nanded.html https://biospectrumindia.com/news/95/20737/metropolis-healthcare-opens-centre-in-nanded.html Thu, 24 Feb 2022 15:10:00 +0530 Metropolis Healthcare has launched an advanced diagnostic testing centre in Nanded, Maharashtra. The 1400 sq ft laboratory can conduct around 400 sample testing per month with a quick turnaround time and high-quality reports.   Inaugurating the new testing centre, Ashokraoji Chavan, PWD Minister, Former Chief Minister, Maharashtra, said “We welcome the Metropolis’ new and advanced diagnostic centre to serve patients in Nanded."   The new laboratory is located at Shop G1, G2 Aagale Complex, Opposite Kalamandir, Nanded- 431602     ]]> <![CDATA[Sanofi, GSK to seek regulatory authorisation for COVID-19 vaccine]]> https://biospectrumindia.com/news/95/20730/sanofi-gsk-to-seek-regulatory-authorisation-for-covid-19-vaccine.html https://biospectrumindia.com/news/95/20730/sanofi-gsk-to-seek-regulatory-authorisation-for-covid-19-vaccine.html Thu, 24 Feb 2022 08:10:00 +0530 Sanofi and GSK intend to submit data from both their booster and Phase 3 efficacy trials as the basis for regulatory applications for a COVID-19 vaccine. The public health relevance of the refrigerator temperature-stable adjuvanted protein-based Sanofi-GSK vaccine is strongly supported by the induction of robust immune responses and a favourable safety profile in multiple settings.    In participants who had received a primary series of an already authorised mRNA or adenovirus vaccine, the Sanofi-GSK booster vaccine induced a significant increase in neutralising antibodies of 18- to 30-fold across vaccine platforms and age groups. When the Sanofi-GSK vaccine was used as a two-dose primary series followed by a booster dose, neutralising antibodies increased 84- to 153-fold compared to pre-boost levels.   When used as a two-dose primary series, the Sanofi-GSK vaccine delivered robust levels of neutralising antibodies, with GMTs reaching 3711 units. For comparison, a panel of sera from volunteers in the same age range who received two doses of an already approved and highly effective mRNA vaccine displayed a GMT of 1653 units, measured simultaneously in the same laboratory.    Across both studies, the Sanofi-GSK vaccine was well-tolerated in younger and older adults with no safety concerns.   The companies are in discussions with regulatory authorities, including the US FDA and European Medicines Agency (EMA), and plan to submit the totality of the data generated with this vaccine candidate to support regulatory authorisations.   ]]> <![CDATA[SIRO Clinpharm introduces hybrid working model]]> https://biospectrumindia.com/news/95/20723/siro-clinpharm-introduces-hybrid-working-model.html https://biospectrumindia.com/news/95/20723/siro-clinpharm-introduces-hybrid-working-model.html Wed, 23 Feb 2022 16:25:00 +0530 SIRO Clinpharm has announced the introduction of a Flexiwork policy for its employees, which would enable them to work within a hybrid environment and enjoy a healthier work-life balance.   SIRO decided to implement a hybrid working policy to create a thought-leader model of flexible working, which allows employees to work from their agreed-upon base location, with robust monitoring mechanisms, and a mandate to attend certain days in the office each month to facilitate team meetings and inter-departmental coordination.      Currently, the company has launched a three-month pilot to test the implementation of the policy which will then be improved and extended based on the feedback and observation from employees and senior stakeholders.    After a thorough analysis and discussion, a minimum of four days of attendance a month for each employee has been mandated. In addition, team meetings and review meetings will be conducted regularly to ensure the connection is maintained between departments and deliverables are met.   As a measure to ensure discipline and a strong framework, the organisation created a web-based calendar system that enables vertical business leads or managers, to plan meetings at the start of the month in the ‘SIRO monthly calendar’ and circulate it to all team members to prepare them for the days they are expected in the office. Each meeting is clearly defined with purpose and objectives and can be customised monthly based on business needs and requirements. . A provision for need-based meetings and reviews have been made a part of the Flexiwork policy.   In addition to the monthly calendar, the company will also maintain a strong mechanism to ensure productivity in the flexible work model by mandating the filing of weekly timesheets, regular catch-up meetings and frequent performance reviews.   ]]> <![CDATA[Bayer throws light on future business plans at Pharma Media Day 2022 ]]> https://biospectrumindia.com/news/95/20722/bayer-throws-light-on-future-business-plans-at-pharma-media-day-2022-.html https://biospectrumindia.com/news/95/20722/bayer-throws-light-on-future-business-plans-at-pharma-media-day-2022-.html Wed, 23 Feb 2022 15:35:00 +0530 At its annual Pharma Media Day 2022, Bayer presented the latest developments in the ongoing transformation of its pharmaceuticals business, which is aimed at delivering long-term, sustainable business growth by bringing forward new options for patients. Bayer’s research and development pipeline continue to grow as the company is building on its existing competencies, such as the expertise around small molecules, while expanding into new modalities, including cell and gene therapies. The company is advancing around 50 projects in ongoing clinical trials across a range of potential therapeutic modalities and indications, with a focus on oncology, cardiovascular and women’s health.In the area of cardiovascular disease, Bayer is delivering on its late-stage pipeline including recent launches of Kerendia (finerenone) and Verquvo (vericiguat).Bayer’s efforts in oncology focus on differentiated approaches that have the potential to fundamentally impact the way that cancer is treated. With three product launches over the last five years, Bayer has significantly broadened its footprint in the area, focusing on those areas with the highest unmet medical need while applying a broad range of modalities. At the same time, the company continues to invest in areas that have the potential to address additional unmet needs in cancer, including targeted radiopharmaceuticals, specifically targeted alpha therapies, next-generation immuno-oncology including oncology cell therapy, as well as precision molecular oncology approaches.Bayer is developing a platform through which healthcare professionals can centrally manage AI-enabled medical imaging and imaging workflow applications. These solutions are being developed by Bayer as well as third parties, and aim to support the complex decision-making processes of healthcare professionals in their task to provide a clear direction from diagnosis to care for their patients.While pursuing research to find new treatment options for gynaecological diseases with a high unmet medical need, the company is also working on addressing women’s health needs during menopause. Elinzanetant, a non-hormonal development compound, is currently being investigated in the Phase III clinical development program OASIS for the treatment of vasomotor symptoms during menopause. As part of this commitment, Bayer recently announced an investment of over €400 million in new production facilities for long-acting reversible contraceptives, including the construction of a new production site in Alajuela, Costa Rica and the expansion of production capabilities in Turku, Finland. ]]> <![CDATA[Azelis strengthens pharma presence in India ]]> https://biospectrumindia.com/news/95/20721/azelis-strengthens-pharma-presence-in-india-.html https://biospectrumindia.com/news/95/20721/azelis-strengthens-pharma-presence-in-india-.html Wed, 23 Feb 2022 13:05:00 +0530 Belgium headquartered Azelis has announced a new agreement with Roquette for the distribution of their pharmaceutical cellulose product range in India. Roquette is a global leader in plant-based ingredients, a pioneer of plant proteins and a leading provider of pharmaceutical excipients.   Roquette’s products, including its plant-based excipients, combined with Azelis’ dedicated application laboratories and formulation proficiency, will allow both companies to provide customers and partners with tailor-made, innovative solutions.    Through this collaboration, Azelis India is expanding its comprehensive product portfolio with the inclusion of Roquette’s Microcrystalline Cellulose (MCC) and Croscarmellose Sodium (CCS) products. The new agreement is effective immediately.   Azelis was appointed as Roquette’s distribution partner for the plant care market in the Asia Pacific in 2020, and Food & Health in China in 2021.     ]]> <![CDATA[Carestream India launches advanced digital radiology solution The DRX Compass]]> https://biospectrumindia.com/news/95/20720/carestream-india-launches-advanced-digital-radiology-solution-the-drx-compass.html https://biospectrumindia.com/news/95/20720/carestream-india-launches-advanced-digital-radiology-solution-the-drx-compass.html Wed, 23 Feb 2022 12:55:00 +0530 Mumbai-based Carestream Health India has launched The DRX Compass, an accurate, convenient and configurable digital radiology solution designed to provide radiologists with a whole new level of efficiency.   Additionally, DRX Compass offers the versatility to build the desired configuration from a wide range of selections in detectors, tubes, generators, tables, collimators, giving radiology facilities full control over how they can use this future-proof digital radiology technology.   The DRX Compass comes in two configurations, Floor Mounted Tube System and Ceiling Suspended Tube System. With colour-coded buttons, optional wall stand angulates, optional auto-centering and a common interface among all Carestream CR/DRX products, technicians can derive the most value from DRX Compass without sacrificing a lot of time and energy in learning how to use the equipment.   There is also an optional Auto-LLI facility that facilitates easy acquisition of long-length imaging.     ]]> <![CDATA[IPA to organise 7th Global Pharma Quality Summit from Feb 24-25, 2022]]> https://biospectrumindia.com/news/95/20718/ipa-to-organise-7th-global-pharma-quality-summit-from-feb-24-25-2022.html https://biospectrumindia.com/news/95/20718/ipa-to-organise-7th-global-pharma-quality-summit-from-feb-24-25-2022.html Tue, 22 Feb 2022 18:30:00 +0530 The Indian Pharmaceutical Alliance (IPA) will host the seventh edition of the 'Global Pharmaceutical Quality Summit (GPQS).' The theme for this year is 'Making quality pharmaceuticals in India, sustainably, for the World' and is scheduled from February 24 to 25, 2022. The forum aims to bring manufacturers and regulators on a common platform to facilitate discussions resulting in meaningful and actionable outcomes in quality. The summit will feature over 30 global leaders and regulators taking part in 15 sessions covering key aspects of manufacturing and quality with a view on sustainability.The conference will commence with a keynote address by S Aparna, Secretary, Department of Pharmaceuticals, and a special address by Dr V G Somani, Drugs Controller General of India. The two-day summit will include technical sessions, panel discussions and special addresses by global subject matter experts on topics such as quality excellence in pharmaceuticals operations, vaccine development, and learnings on quality excellence from other industries, among others. The concluding session will have a CEO panel discussion from leading Indian Pharma companies such as Cadila, Cipla, Dr Reddy’s, Lupin, Sun Pharma, and Torrent Pharma to deliberate on ‘Sustainable end-to-end operations & Quality Excellence.’The key regulators joining the Summit are Dr V G Somani, DCG(I), Dr Rogério Gaspar, Director, Regulation and Prequalification Department, WHO, Dr Manisha Shridhar, Regional Advisor, WHO – SEARO, Dr Douglas Throckmorton, Deputy Director for Regulatory Platforms, USFDA, Kristan Callahan, International Relations Specialist, USFDA India Office and Dr Sotirios Paraschos, Inspector, Certification of Substances Department, EDQM The forum is expected to witness participation from 1000+ registered participants, and invitees from CDSCO, media, senior leadership WHO India Office, USFDA India Office, IGBA, PDA, USP, OPPI, IDMA, Academia and IPA Executive Council. The knowledge partner for the summit is McKinsey & Company and collaborators are Invest India, USP and PDA. ]]> <![CDATA[US-based Velocity Clinical Research acquires TrierHealth in Hyderabad]]> https://biospectrumindia.com/news/95/20715/us-based-velocity-clinical-research-acquires-trierhealth-in-hyderabad.html https://biospectrumindia.com/news/95/20715/us-based-velocity-clinical-research-acquires-trierhealth-in-hyderabad.html Tue, 22 Feb 2022 15:40:00 +0530 US-based Velocity Clinical Research (Velocity), a fully integrated clinical site organisation, has announced the acquisition of TrierHealth, a digital clinical trials platform whose R&D team operates out of Hyderabad, to develop patient-focussed technology. TrierHealth's founder, Raghu Punnamraju, will become Velocity's Chief Technology Officer.   The investment in Indian clinical technology expertise in Hyderabad comes amid the clinical trials sector's move towards decentralised trials. Velocity Clinical Research operates 30 locations across the US and will expand to other regions this year, adopting a hybrid solution of both brick-and-mortar sites plus technology elements to facilitate greater patient recruitment into clinical research globally, speeding up drug development.   Velocity will embark on an aggressive recruitment drive for clinical technology talent in Hyderabad, critical to the company's growth as a global clinical trials player. Velocity, now with its acquired technical capability, will develop patient-focused tech to increase patient engagement amongst its database of 500,000 patients, increasing the frequency of people taking part in multiple studies.   The acquisition of TrierHealth means Velocity can develop applications that harness the power of AI and data science to improve clinical research. The acquisition comes 18 months after collaborating with TrierHealth to build a patient-focused platform to support decentralised visits. The R&D team, based in Hyderabad, will now expand and focus on patient recruitment and retention applications.     ]]> <![CDATA[Binnopharm to acquire anti-bacterial brands from Dr Reddy’s in Russia, CIS region]]> https://biospectrumindia.com/news/95/20706/binnopharm-to-acquire-anti-bacterial-brands-from-dr-reddys-in-russia-cis-region.html https://biospectrumindia.com/news/95/20706/binnopharm-to-acquire-anti-bacterial-brands-from-dr-reddys-in-russia-cis-region.html Mon, 21 Feb 2022 18:40:00 +0530 Russia-based Sistema Group company Binnopharm Group via its affiliate Joint Stock Company ‘Alium’, and Hyderabad-based Dr Reddy's has announced the signing of a deal that will allow Binnopharm Group to acquire anti-bacterial medicines under the Ciprolet and Levolet brands from Dr Reddy’s in Russia, Uzbekistan and Belarus. The portfolio includes various dosage forms such as tablets, solutions for infusions and eye drops.Rustem Muratov, CEO of the Binnopharm Group said, “We are also acquiring rights to these products in Belarus and Uzbekistan in line with our strategic goal to strengthen presence in the international markets.”MV Ramana, CEO – Branded Markets (India & Emerging Markets), said: “Our Russia and CIS markets continue to be strong performers for the company. This deal is a step towards divesting brands in non-core areas to consolidate and strengthen our play further in our key focus therapy areas of gastroenterology, pain management, cold and flu, allergy, oncology, neurology, paediatrics and women’s health." ]]> <![CDATA[CEPI, THSTI, Panacea Biotec partner to develop Betacoronavirus vaccines]]> https://biospectrumindia.com/news/95/20704/cepi-thsti-panacea-biotec-partner-to-develop-betacoronavirus-vaccines.html https://biospectrumindia.com/news/95/20704/cepi-thsti-panacea-biotec-partner-to-develop-betacoronavirus-vaccines.html Mon, 21 Feb 2022 18:15:00 +0530 Norway-based Coalition for Epidemic Preparedness Innovations (CEPI) will partner with a consortium consisting of the Translational Health Science and Technology Institute (THSTI), an autonomous institute of the Department of Biotechnology, Ministry of Science and Technology, Government of India and New Delhi-based Panacea Biotec to develop vaccine candidates that could provide broad protection against SARS-Cov-2 variants and other Betacoronaviruses.   CEPI will provide funding of up to $12.5 million to support the development of multi-epitope, nanoparticle-based vaccine candidates and advance the manufacturing process.   Through this research programme, THSTI and Panacea Biotec will design and select the lead antigen through proof-of-concept preclinical studies, and undertake initial clinical development through Phase I/II studies as they seek to establish clinical proof of concept for novel vaccine candidates to provide broad protection against MERS, SARS-CoV, SARS-CoV-2 and its variants. ]]> <![CDATA[Jubilant Ingrevia commissions new UP facility for Diketene]]> https://biospectrumindia.com/news/95/20697/jubilant-ingrevia-commissions-new-up-facility-for-diketene.html https://biospectrumindia.com/news/95/20697/jubilant-ingrevia-commissions-new-up-facility-for-diketene.html Fri, 18 Feb 2022 17:25:00 +0530 Jubilant Ingrevia has announced the commissioning of its new Diketene derivatives facility at its manufacturing site in North India at Gajraula, Uttar Pradesh. The newly commissioned facility marks the entry of Jubilant Ingrevia into the fast-growing Diketene business portfolio. This reiterates Jubilant Ingrevia's commitment towards growth through its integrated business model, by providing value-added products and innovative solutions to its customers.The commissioned facility has about 7,000 TPA capacity to produce various esters (Mono Methyl Acetoacetamide, Methyl Acetoacetate, Ethyl Acetoacetate and Ter-Butyl Acetoacetate). Jubilant Ingrevia undertakes to commission future phases of Diketene Derivatives as per plan.  ]]> <![CDATA[RisamPure launches AtmoPure air purifiers]]> https://biospectrumindia.com/news/95/20696/risampure-launches-atmopure-air-purifiers.html https://biospectrumindia.com/news/95/20696/risampure-launches-atmopure-air-purifiers.html Fri, 18 Feb 2022 17:15:00 +0530 RisamPure, owned by the former promotors of Bharat Serums & Vaccines Ltd (BSVL), has launched AtmoPure range of air purifiers. Aimed at providing the best health care and well-being products in India, RisamPure will be introducing two variants - Medical Grade Hepa 14 Range and Advanced Grade Hepa 13 Range.    AtmoPure air purifiers are built to proactively protect your health by ensuring no air-borne threats escape into the air you breathe. Atmopure air purifiers with its state-of-the-art five-stage purification system inside, and eliminates all kinds of air-borne threats, as they come with built-in Pre-Filter + Activated Carbon Filter + ‘3D Attack’ Technology.   Going forward, the company plans to conduct extensive research to come up with more innovative healthcare solutions. RisamPure plans to expand its portfolio by bringing in more products in the purification range targeting B2B and other segments.  ]]> <![CDATA[Aster Labs launches advanced pathology lab in Visakhapatnam]]> https://biospectrumindia.com/news/95/20681/aster-labs-launches-advanced-pathology-lab-in-visakhapatnam.html https://biospectrumindia.com/news/95/20681/aster-labs-launches-advanced-pathology-lab-in-visakhapatnam.html Thu, 17 Feb 2022 14:40:00 +0530 Aster Labs, the diagnostic wing of Aster DM Healthcare, has announced the launch of its pathology lab in Visakhapatnam, Maddilapalem, Andhra Pradesh. Aster Labs Visakhapatnam will soon be equipped to perform the COVID-19 RT-PCR test and will provide accurate results in less than 12 hours to patients.    Some of the quality diagnostic services offered by Aster Labs range from routine test investigations like blood test, urine test, stool test, biopsy test to more advanced tests on biochemistry, haematology, microbiology, clinical pathology, histopathology, cytogenetics, molecular diagnostics, and flow cytometry.   Patients can avail the home collection service from the comfort of their homes. ]]> <![CDATA[Metropolis Healthcare opens centre in Asansol]]> https://biospectrumindia.com/news/95/20679/metropolis-healthcare-opens-centre-in-asansol.html https://biospectrumindia.com/news/95/20679/metropolis-healthcare-opens-centre-in-asansol.html Thu, 17 Feb 2022 13:00:00 +0530 Metropolis Healthcare has launched an advanced diagnostic testing centre in Asansol, West Bengal. The 900 sq ft laboratory can conduct around 1000 sample testing per month with a quick turnaround time and high-quality reports.   Metropolis Laboratories offers different tests ranging from basic day-to-day pathology tests to high-end molecular diagnostic tests, and reports of the highest quality at affordable rates. The new laboratory is located at West Apcar Garden, G.T.Road (West), Paschim Bardhaman, Asansol. ]]> <![CDATA[Mankind Pharma acquires Combihale, Daffy brands from Dr Reddy’s Laboratories]]> https://biospectrumindia.com/news/95/20671/mankind-pharma-acquires-combihale-daffy-brands-from-dr-reddys-laboratories.html https://biospectrumindia.com/news/95/20671/mankind-pharma-acquires-combihale-daffy-brands-from-dr-reddys-laboratories.html Wed, 16 Feb 2022 13:55:00 +0530 New Delhi-based Mankind Pharma has entered into an agreement with Dr Reddy’s Laboratories in Hyderabad to acquire two of its brands Combihale and Daffy.   Combihale is used for the treatment of asthma and chronic obstructive pulmonary disease. The market for this category is valued at ~ Rs 900 crores growing at 14 per cent (IQVIA). The acquisition of Combihale is expected to strengthen Mankind’s presence in the inhalation respiratory market segment.   Daffy is a soap-free moisturising bar for infant babies. The total market for this category is valued at ~ Rs 1000 crores growing at 18 per cent (IQVIA).   As per the terms of the definitive agreement executed between the companies, Mankind Pharma will take over the manufacturing, marketing and distribution of both products in India. The entire integration and transition of the brands are expected to be completed by March 2022. ]]> <![CDATA[Kriya Medical Technologies bags manufacturing license for RT-PCR Kit ]]> https://biospectrumindia.com/news/95/20629/kriya-medical-technologies-bags-manufacturing-license-for-rt-pcr-kit-.html https://biospectrumindia.com/news/95/20629/kriya-medical-technologies-bags-manufacturing-license-for-rt-pcr-kit-.html Mon, 14 Feb 2022 14:30:00 +0530 Kriya Medical Technologies has received its manufacturing license from the DCGI (Drugs Controller General of India) for its product KRIVIDA Novus, an RT-PCR kit that can detect the Omicron variant and its sub-lineages in 45 minutes.    Priced at Rs 150 +taxes, the test is affordable and most suitable for entry point screening at airports. The kit is compatible with Real-Time PCR machines with a test run time of roughly 45 minutes. It provides an early report to aid diagnosis and also gives precise variants to enable appropriate treatment.    KRIVIDA Novus will be produced at Kriya’s state-of-the-art manufacturing facility in Oragadam in Chennai. The company currently has a production capacity of 5 million tests per month and plans to increase it to 10 million tests per month within the next two weeks.    ]]> <![CDATA[Merck India celebrates Women in Science with #MforHer]]> https://biospectrumindia.com/news/95/20619/merck-india-celebrates-women-in-science-with-mforher.html https://biospectrumindia.com/news/95/20619/merck-india-celebrates-women-in-science-with-mforher.html Fri, 11 Feb 2022 00:00:00 +0530 Merck has announced an initiative #MForHER to celebrate and acknowledge the contribution of women in scientific research. Science and gender equality are vital to our world’s aspiring sustainable development goals. The initiative has been launched in the week of International Women’s Day of Women & Girls in Science, to celebrate their achievements in the field of science and technology and recognize them for their hard work and dedication. According to UNESCO’s 2019 data, less than 30 percent of researchers worldwide are women. In recent years, the gender gap in STEM fields has successively decreased. Thanks to the indomitable spirit of all women in science who are role models to the next generation of curious minds. The International Women and Girls in Science Day observed every year on February 11, encourages girls and women to pursue professions in STEM-related fields and honors their scientific contributions. The company takes immense pride as 53% of its global R&D workforce are women. The campaign celebrates the indomitable spirit and commitment and aims to support more girls to adopt a career in STEM. The posts encourage followers to share their thoughts on social channels using the hashtag #MForHER while nominating them for a surprise gift, while telling her how amazing she is with a personalized card. ]]> <![CDATA[Novartis signs agreement with Dr Reddy's to extend access of medicines]]> https://biospectrumindia.com/news/95/20621/novartis-signs-agreement-with-dr-reddys-to-extend-access-of-medicines.html https://biospectrumindia.com/news/95/20621/novartis-signs-agreement-with-dr-reddys-to-extend-access-of-medicines.html Fri, 11 Feb 2022 00:00:00 +0530 Novartis India has announced an exclusive sales and distribution agreement with Dr Reddy’s Laboratories for a few of its established medicines which includes the Voveran range, the Calcium range and Methergine. This arrangement aims to further broaden access of these medicines beyond the current geographies to benefit many more patients, more efficiently, by significantly extending the reach of healthcare professionals through an expanded field force. This brings together the manufacturing and development synergies of Novartis India with the sales and distribution strengths of Dr Reddy’s. Sanjay Murdeshwar, Country President and Managing Director, Novartis in India, said, “Today, on one hand, keeping the patient interest at the center, we have entered this strategic business arrangement with Dr. Reddy’s Laboratories to extend access to our Established Medicines to benefit more patients in India efficiently. On the other hand, we understand the implication on the roles of our colleagues in Novartis India Limited and are doing our best to support them.” Novartis has a large footprint in India with over 10,000 full time employees. Since January 2020, Novartis has hired more than 1,600 employees across the Novartis divisions and companies in India are planning to continue this hiring programme in 2022. Over the last five years, Novartis has spent over $300 million in creating an R&D support center and services in India. Novartis is also in the process of expanding further by setting up an additional manufacturing plant at Kalwe, with an investment of approximately $49 million. This plant would manufacture oral cancer medicines for the global market.   ]]> <![CDATA[Piramal Pharma Solutions strengthens presence in the UK]]> https://biospectrumindia.com/news/95/20611/piramal-pharma-solutions-strengthens-presence-in-the-uk.html https://biospectrumindia.com/news/95/20611/piramal-pharma-solutions-strengthens-presence-in-the-uk.html Thu, 10 Feb 2022 00:00:00 +0530 The Pharma Solutions division of Piramal Pharma, Mumbai-based contract development and manufacturing company (CDMO), has announced the expansion of its antibody-drug conjugate (ADC) manufacturing capabilities at the Grangemouth facility in Scotland and investment in new Active Pharmaceutical Ingredients (API) infrastructure at the Morpeth facility in England.  Taken together, these expansions and modernizations represent a total investment of approximately £55 million in the company's UK drug development and manufacturing operations and provide new employment opportunities for technical and operational staff. The first phase of the expansion of the Grangemouth site will add two additional ADC production facilities to the existing three, which will be operational by the third quarter of 2023.  This extension represents an investment of £45 million including a £2.4 million grant from Scottish Enterprise, Scotland's national business development agency. The investment in API capacity at the Morpeth site, valued at approximately £10 million, includes new plant, infrastructure and utility systems. Piramal is investing £8 million directly while the UK Government is contributing £2 million to the project. ]]> <![CDATA[Aragen receives Great Place to Work certification]]> https://biospectrumindia.com/news/95/20606/aragen-receives-great-place-to-work-certification.html https://biospectrumindia.com/news/95/20606/aragen-receives-great-place-to-work-certification.html Wed, 09 Feb 2022 19:10:00 +0530 Aragen Life Sciences has been certified by Great Place to Work (GPTW) institute as one of India’s top workplaces for the third year in a row. This makes Aragen one of the few companies in India to achieve consecutive GPTW certifications. The certificate, valid for the period February 2022 to February 2023, is given to companies that promote a better, more inclusive work environment that fosters high trust and performance culture.    88 per cent of employees, who participated in the survey, have ranked Aragen as a great place to work. Being certified for three years in a row is a sign of Aragen’s “gold standard” workplace and culture and is indicative of the quality of life employees enjoy within the company. It is a validation of the company's employee centricity, values, culture, and efforts to nurture its talent pool.    ]]> <![CDATA[Lupin signs distribution agreement with Medis for orphan drug NaMuscla]]> https://biospectrumindia.com/news/95/20605/lupin-signs-distribution-agreement-with-medis-for-orphan-drug-namuscla.html https://biospectrumindia.com/news/95/20605/lupin-signs-distribution-agreement-with-medis-for-orphan-drug-namuscla.html Wed, 09 Feb 2022 19:05:00 +0530 Lupin has entered into a distribution agreement with Medis for Lupin’s orphan drug NaMuscla (mexiletine). Medis will commercialise NaMuscla for the symptomatic treatment of myotonia in adults with non-dystrophic myotonic (NDM) disorders in Central and Eastern Europeancountries. NaMuscla is the first and only licensed product for this indication.Under the agreement, Medis will initially focus on the commercialisation of NaMuscla in the Central and East European countries, namely Croatia, Czech Republic, Hungary, Slovakia, and Slovenia in the first phase. Lupin will continue commercialisation of NaMuscla in Germany, France, and the UK. ]]> <![CDATA[MaxiVision forays into Tamil Nadu, Karnataka ]]> https://biospectrumindia.com/news/95/20602/maxivision-forays-into-tamil-nadu-karnataka-.html https://biospectrumindia.com/news/95/20602/maxivision-forays-into-tamil-nadu-karnataka-.html Wed, 09 Feb 2022 12:45:00 +0530 MaxiVision Eye Hospitals have announced their expansion plans to Tamil Nadu and Karnataka. With over 27 years of stellar practice in the states of Andhra and Telangana, the group is the first choice of quality eye care with superior technology, for the population of these two states.Dr GSK Velu, Chairman, MaxiVision Eye Hospitals said, “The expansion plan was set back for a while bidding for Vasan Eye Care, which the company has withdrawn due to various reasons. We are starting with one super specialty eye hospital in Tiruchirappalli, and expanding to other districts of Tamil Nadu within the next six months. We are fortunate to have the leadership of Dr Shibu Varkey, a leading ophthalmologist in Chennai, with over 25 years of experience and performed over a lakh of surgeries. Dr Varkey, as Regional Medical Director, along with his team of eight other surgeons, and experienced management professionals will head the Trichy Cluster, which will spearhead our aggressive expansion plans in entire Tamil Nadu. In phase two, we will enter Karnataka, and Kerala, along with our organic expansion in other districts of Andhra Pradesh and Telangana." Sudheer, Group CEO, MaxiVision Eye Hospitals, said “MaxiVision will set up Super Specialty Tertiary care eye hospitals, in potential districts of Trichy, Salem, Madurai, Coimbatore, and Chennai, as hub centres supported by spoke secondary care eye hospitals, around these hubs in Tanjore, Kumbakonam, Perambalur, Erode, Namakkal, Dharmapuri, Tuticorin, Tiruppur, Pollachi, Vellore, and Hosur, within this year. In the year 2023, we will also start our first hospital in Karnataka, in Bengaluru. The aggressive expansion plan will add 14 hospitals next year to the group, led by a team of 48 doctors and around 1000 patient care teams to give exemplary patient care in these hospitals. We are also in the process of engaging key doctors in Bangalore and other potential districts of Karnataka, along with districts in North Kerala, with senior surgeons to head the hospitals in these states." ]]> <![CDATA[Glenmark launches FabiSpray in India for COVID-19 treatment]]> https://biospectrumindia.com/news/95/20600/glenmark-launches-fabispray-in-india-for-covid-19-treatment.html https://biospectrumindia.com/news/95/20600/glenmark-launches-fabispray-in-india-for-covid-19-treatment.html Wed, 09 Feb 2022 11:05:00 +0530 Glenmark Pharmaceuticals and Canadian pharmaceutical company SaNOtize Research & Development Corp have launched its nitric oxide nasal spray (NONS) under the brand name FabiSpray in India.   The nasal spray will be used for the treatment of adult patients with COVID-19 who have a high risk of progression of the disease.    Glenmark earlier received manufacturing and marketing approval from the Drugs Controller General of India (DCGI) for NONS as part of the accelerated approval process.   FabiSpray, Nitric Oxide Nasal Spray, is designed to kill the COVID-19 virus in the upper airways. It has proven anti-microbial properties with a direct virucidal effect on SARS-CoV-2. NONS when sprayed over nasal mucosa acts as a physical and chemical barrier against the virus, preventing it from incubating and spreading to the lungs.   A Phase 3 clinical trial was conducted in adult COVID-19 patients across 20 clinical sites in India.  ]]> <![CDATA[37% increase in demand for aesthetic procedures in India: Menarini survey]]> https://biospectrumindia.com/news/95/20599/37-increase-in-demand-for-aesthetic-procedures-in-india-menarini-survey.html https://biospectrumindia.com/news/95/20599/37-increase-in-demand-for-aesthetic-procedures-in-india-menarini-survey.html Wed, 09 Feb 2022 09:20:00 +0530 While navigating the COVID-19 pandemic, Indians are increasingly adopting cosmetic procedures. The survey conducted by biopharmaceutical company Menarini among 100 dermatologists and plastic surgeons across India, revealed that 65 per cent of the respondents agree that facelift is the most sought-after facial aesthetic procedure in India right now.    The survey reveals that 37 per cent of the respondents have observed increased demand for aesthetic procedures since the onset of the global COVID-19 pandemic. 76 per cent of the respondents attributed this trend to the desire to look good and showcase a perfect life on social media. On the other hand, 35 per cent of respondents said that the COVID-19 induced lockdown and subsequent work from home has made people conscious of how they look on screen. Terms like Zoom effect, Zoom boom, and Zoom Dysmorphia has entered their lexicon, making them opt for cosmetic procedures.    98 per cent of the respondents said that while women aged between 35-50 years remain the top candidate for aesthetic procedures, there is a shift witnessed in the age group as more women between the age group 25-35 years are stepping forward and showing interest in cosmetic surgeries and aesthetic procedures. On the other hand, men are also increasingly adopting cosmetic procedures in India. 79 per cent of the respondents have seen an influx of men aged 35-50 years coming in for consultations and choosing surgical procedures for a ‘quick fix’ or 'tweakments,' as they become more conscious about their appearance.    71 per cent of the respondents feel that aesthetic procedure is still a taboo subject in India, however, the stigma around the issue has started to recede with positive conversations on social media by celebrities and influencers sharing their experiences and stories.  ]]> <![CDATA[Abbott in collaboration with health tech partners for diabetes care]]> https://biospectrumindia.com/news/95/20596/abbott-in-collaboration-with-health-tech-partners-for-diabetes-care.html https://biospectrumindia.com/news/95/20596/abbott-in-collaboration-with-health-tech-partners-for-diabetes-care.html Tue, 08 Feb 2022 16:35:00 +0530 Abbott announced new collaborations with key health-tech partners BeatO, Sugar.fit, PharmEasy, GOQii, 1MG, Zyla Health, Healthifyme and Fitterfly to usher new era of holistic diabetes management care. Through these collaborations, Abbott aims to offer glucose monitoring solutions to 8 million people living with diabetes, of which approximately 6.5 million users can access through PharmEasy and 1MG. The company is focussed on maintaining effective glucose levels along with remote consultations, diabetes-specific coaching, and dietary plans.  ]]> <![CDATA[Skye Air Mobility ties up with Redcliffe Labs]]> https://biospectrumindia.com/news/95/20592/skye-air-mobility-ties-up-with-redcliffe-labs.html https://biospectrumindia.com/news/95/20592/skye-air-mobility-ties-up-with-redcliffe-labs.html Tue, 08 Feb 2022 12:50:00 +0530 Skye Air Mobility, a drone delivery logistics provider has signed a long term agreement with Delhi- NCR-based Redcliffe Labs. The partnership is first-of-its-kind in the diagnostics space for faster supply chain for sample collection to cater to urban, semi-urban and remote corners of the country using drone delivery technology.    Skye Air will conduct BVLOS drone delivery trials in a select corridor and subsequently followed on by commercial roll-outs in several urban and remote locations in India.   Around 30-40 test flights will be conducted from Redcliffe Lab’s National Reference Lab in Noida from mid February onwards. The engagement shall also capture deploying drones in Himachal Pradesh, Uttarakhand, J&K and North Eastern states. ]]> <![CDATA[Venus Remedies joins AMR Industry Alliance to combat imminent global health threat]]> https://biospectrumindia.com/news/95/20584/venus-remedies-joins-amr-industry-alliance-to-combat-imminent-global-health-threat.html https://biospectrumindia.com/news/95/20584/venus-remedies-joins-amr-industry-alliance-to-combat-imminent-global-health-threat.html Mon, 07 Feb 2022 18:55:00 +0530 Venus Remedies has joined the league of over 100 globally renowned organisations as a member of the AMR Industry Alliance (AMRIA) in continuation of its commitment to developing solutions to combat the grave public health threat posed by antimicrobial resistance (AMR).   Welcoming Venus Remedies as a new member, Melissa Mitchell, Secretariat Lead of AMR Industry Alliance, said, “As an organisation, they lead by example and make commendable efforts to counter the threat of AMR by improving the access of AMR-relevant drugs to third-world countries and encouraging appropriate antibiotic use, along with good stewardship activities."   Hailing the membership as an endorsement of the notable work done by Venus Remedies to tackle AMR, Saransh Chaudhary, CEO, Venus Medicine Research Centre (VMRC), said, “ It is an honour to collaborate with the global life sciences industry under the aegis of the AMR Industry Alliance and devise sustainable solutions to AMR. I hope this association will amplify our existing efforts against AMR at a global level by shaping relevant AMR policies and plugging the leaks in the current antibiotic research and manufacturing landscape with a focus on access and appropriate use.” ]]> <![CDATA[Lay Sciences unveils COVID-19 neutralising antibody mouth wash]]> https://biospectrumindia.com/news/95/20582/lay-sciences-unveils-covid-19-neutralising-antibody-mouth-wash.html https://biospectrumindia.com/news/95/20582/lay-sciences-unveils-covid-19-neutralising-antibody-mouth-wash.html Mon, 07 Feb 2022 00:00:00 +0530 Lay Sciences, has announced the launch of its flagship product ImmunIgY, the first-in-class product that contains pre-formed (instant) antibodies that neutralize SARS-CoV-2 virus.  ImmunIgY is also effective against the Delta and Omicron variants of the virus. ImmunIgY when used as an “oral rinse and swallow” product is a useful addition in preventing the onset, transmission, and progression of the disease.ImmunIgY – The “Instant Antibodies” in ImmunIgY is based on a futuristic IgY technology and established scientific principles which allows the antibodies to attach to the virus at the point of entry into the body and neutralizes it. The antibodies in ImmunIgY are derived from hyperimmunized chicken eggs and are safe for human consumption. It specifically targets the viral protein that binds to human cell receptors to gain entry to cells of the mouth and throat-a major access point for the virus. Formulated as an orange flavoured powder, ImmunIgY easily dissolves in drinking water and is used as a beverage following oral rinsing and swishing. Using its patented and proprietary technologies licensed from its partnering companies, ReaGene Biosciences Pvt. Ltd. in Bengaluru, Prodigy Biotech, Inc. in the US and Kyntox Biotech India Pvt. Ltd. in Bengaluru, Lay Sciences is dedicated to developing and providing innovative products focused on treating and preventing diseases of the GI tract. Lay Sciences officially launched ImmunIgY through its worldwide distributor HealthAngels Pvt. Ltd. (UK), in Europe, Asia and Africa, and is expected to be launched in other territories worldwide over this quarter. ImmunIgY has received the European market (CE-Mark) approval by the European Union. ]]> <![CDATA[Cadila Pharma offers solution to treat dry skin conditions]]> https://biospectrumindia.com/news/95/20568/cadila-pharma-offers-solution-to-treat-dry-skin-conditions.html https://biospectrumindia.com/news/95/20568/cadila-pharma-offers-solution-to-treat-dry-skin-conditions.html Fri, 04 Feb 2022 16:05:00 +0530 Cadila Pharma has launched lotion to treat dry skin conditions. Laglo Soft Lotion comes with a unique technology that enhances moisturisation and restructures the skin.   Launching another product in the skincare category, drug major Cadila Pharmaceuticals has launched an intensely moisturising formula to treat dry skin conditions.   Christened Laglo Soft Lotion, the formula is used to treat dry skin conditions and associated disorders. It is proven to be effective in treating xerosis, ichthyosis, atopic dermatitis, psoriasis, skin ageing, and co-therapy with corticosteroids.   The formula’s unique technology not only leads to enhanced moisturisation but also restructures the skin.   The Laglo Soft Lotion is based on the “3D Aquaporin Hydraconcept” and contains ‘Aquaxyl’ that boosts Hyaluronic Acid Production and increases the genetic expression of the Aquaporin AQP3 membrane for long-lasting hydration for intensive moisture retention and barrier component booster.  ]]> <![CDATA[LG to donate Rs 25,00,000 to create cancer awareness]]> https://biospectrumindia.com/news/95/20566/lg-to-donate-rs-2500000-to-create-cancer-awareness.html https://biospectrumindia.com/news/95/20566/lg-to-donate-rs-2500000-to-create-cancer-awareness.html Fri, 04 Feb 2022 15:35:00 +0530 LG Electronics extends support to the Indian Cancer Society to help fight against cancer. The CSR initiative by LG will help people who cannot afford cancer screening. The initiative aims to conduct 10 screening camps and targets to screen around 1,100 individuals in Delhi NCR. Under this initiative, LG plans to donate Rs 25,00,000 which will help raise awareness and advocacy and set up the screening camps. Young Lak Kim, MD- LG Electronics India said, “We are honoured to associate with Indian Cancer Society to help the community with better health. This will help us continue our social initiatives to contribute in a meaningful way.”“We are thankful to LG Electronics for their support. Initiatives like these not only help us engage with the vulnerable community but also allows us to introduce the concept of cancer awareness, myths and stigmas associated with it and the importance of early screening so that individuals take charge of their health”, said Renuka Prasad- Hon Secretary Indian Cancer Society – Delhi Branch. ]]> <![CDATA[Lupin posts gross profit of Rs 23,929 M in Q3 FY2022]]> https://biospectrumindia.com/news/95/20563/lupin-posts-gross-profit-of-rs-23929-m-in-q3-fy2022.html https://biospectrumindia.com/news/95/20563/lupin-posts-gross-profit-of-rs-23929-m-in-q3-fy2022.html Fri, 04 Feb 2022 12:50:00 +0530 In Q3 FY2022, the gross profit was Rs 23,929 million compared to Rs 23,769 million in Q2 FY2022, with a margin of 58.5 per cent. The personnel cost was 18.2 per cent of sales at Rs 7,438 million compared to Rs 7,586 million in Q2 FY2022. Manufacturing and other expenses were 33.1 per cent of sales at Rs 13,518 million compared to Rs 11,425 million inQ2 FY2022. Investment in R&D for the quarter was Rs 3,546 million (8.7 per cent of sales).Nilesh Gupta, MD, Lupin said, “We are on the path of sustainedgrowth across markets. Our inhalation portfolio continues to build share in the U.S. and helped register double-digit growth sequentially, despite pricing and demand challenges on seasonal products. The inflationary environment has impacted margins, but we remain focussed on margin and EBIDTA improvement as we deliver on key product launches, cost optimization and improving efficiencies, especially by H2 FY23." ]]> <![CDATA[Eyestem Research successfully completes study for treating Dry AMD]]> https://biospectrumindia.com/news/95/20562/eyestem-research-successfully-completes-study-for-treating-dry-amd.html https://biospectrumindia.com/news/95/20562/eyestem-research-successfully-completes-study-for-treating-dry-amd.html Fri, 04 Feb 2022 08:35:00 +0530 Bengaluru-based firm Eyestem Research has announced the successful completion of its dose-ranging study in animals for Eyecyte-RPE.   Eyecyte-RPE is a suspension of Retinal Pigment Epithelium Cells for treatment of Dry Age-Related Macular Degeneration (AMD). 170 million people worldwide suffer from this disease, 40 million of which are in India.    While Eyecyte-RPE, the company’s patented flagship product, is close to finding a treatment for Dry AMD, the company has two more products in the pipeline for Retinitis Pigmentosa and Idiopathic Pulmonary Fibrosis - similar incurable diseases affecting humanity. First, human clinical trials for Eyecyte-RPE are currently scheduled for the last quarter of 2022.    Dr Rajarshi Pal, Co-Founder and Chief Scientist, Eyestem Research, said, “When injected into an inherited rat model with retinal degeneration, Eyecyte-RPE supported vision rescue demonstrated by a whole range of histological, functional and behavioural tests and helps retain the structural integrity of the host retina. These results will allow us to move forward with final manufacturing followed by toxicity studies and start human studies in the last quarter of 2022."   Founded by a highly experienced management team consisting of ophthalmology, regenerative medicine and clinical trial experts, Eyestem has created a platform for allogeneic, scalable cell therapy.    ]]> <![CDATA[NephroPlus unveils two apps for better dialysis care]]> https://biospectrumindia.com/news/95/20552/nephroplus-unveils-two-apps-for-better-dialysis-care.html https://biospectrumindia.com/news/95/20552/nephroplus-unveils-two-apps-for-better-dialysis-care.html Thu, 03 Feb 2022 12:50:00 +0530 Hyderabad-based NephroPlus has launched two apps to help provide support for dialysis patients and nephrologists. The first-of-its-kind innovation consists of a Patient App and a Nephrologist App, available on both Android and iOS, where important information related to patient medical history and dialysis, in general, is available at the fingertips.   With the patient app, NephroPlus patients can now book dialysis sessions with just a few taps, book holiday dialysis sessions anywhere in India, get access to the largest directory of dialysis friendly recipes, access prescriptions and investigation results, consult a dietician for free, pay for sessions without having to carry cash and cards to the dialysis centre and book video consults with nephrologists. Nephrologists can see the entire clinical history of their patients through the app.   NephroPlus will conduct occasional quizzes and contests with questions sent as alerts and guests who provide the right answers will win badges that can further be redeemed against services at the centre. This innovation is a welcome development. This app is available to download for both iOS and Android users immediately, bringing convenience to both patients and nephrologists in their journey with NephroPlus. ]]> <![CDATA[Global 3D Labs develops 3D bio printers for skin]]> https://biospectrumindia.com/news/95/20548/global-3d-labs-develops-3d-bio-printers-for-skin.html https://biospectrumindia.com/news/95/20548/global-3d-labs-develops-3d-bio-printers-for-skin.html Wed, 02 Feb 2022 00:00:00 +0530 Bengaluru-based Avay  has announced the successful development of 3D bio printers. The company is currently focusing on printing skin for drug testing application. A patent has already been filed for the technology. At the same time, Global 3D Labs is working on developing 3D printer for the pharma application such as customised tablets. The novel product is expected to be ready in the next quarter. The company has operations in Mumbai, Hyderabad and Bengaluru.   ]]> <![CDATA[GI Dynamics bags approval for I-STEP clinical study of diabetes & obesity in India]]> https://biospectrumindia.com/news/95/20522/gi-dynamics-bags-approval-for-i-step-clinical-study-of-diabetes-obesity-in-india.html https://biospectrumindia.com/news/95/20522/gi-dynamics-bags-approval-for-i-step-clinical-study-of-diabetes-obesity-in-india.html Tue, 01 Feb 2022 14:35:00 +0530 GI Dynamics, a US-based medical device company that is developing the EndoBarrier System for patients diagnosed with type 2 diabetes and obesity, has received regulatory approval to begin enrollment in the I-STEP clinical trial in India.   I-STEP is a multi-centre, randomised, pivotal study evaluating the safety and efficacy of EndoBarrier for glycemic improvement in patients with inadequately controlled type 2 diabetes and obesity and will be conducted exclusively in partnership with the Apollo Hospital System and Apollo Sugar Clinics.   This study, which is intended to follow 100 subjects up to 24 months, will evaluate EndoBarrier in patients who fall within a predetermined haemoglobin A1c range.    In addition to partnership in the I-STEP clinical trial, GI Dynamics and Apollo Sugar have agreed to work toward setting the terms of a joint-partnership that will focus on the marketing, distribution, and clinical support of EndoBarrier® to appropriate patients throughout India and Southeast Asia.   ]]> <![CDATA[Lupin in agreement with Axantia for Pegfilgrastim in Middle East, North Africa]]> https://biospectrumindia.com/news/95/20520/lupin-in-agreement-with-axantia-for-pegfilgrastim-in-middle-east-north-africa.html https://biospectrumindia.com/news/95/20520/lupin-in-agreement-with-axantia-for-pegfilgrastim-in-middle-east-north-africa.html Tue, 01 Feb 2022 12:35:00 +0530 Lupin has entered into a license, supply and technology sharing agreement with Axantia Holding (Axantia), a leading pharmaceutical company in the Middle East region operating through its pharmaceuticalsubsidiaries; Pharma International Company and Med City Pharmaceutical Industries. Under the terms of the agreement, Axantia will register, distribute and market biosimilar Pegfilgrastim drug products incertain territories including Saudi Arabia, certain GCC countries, Jordan, Lebanon, Iraq, Sudan, Libya and Algeria.Lupin had earlier received the US FDA acceptance for review of the Biologics License Application (BLA) for its proposed biosimilar to Neulasta (pegfilgrastim) through a filing using the 351(k) pathway.Pegfilgrastim is indicated to reduce the duration of neutropenia and the incidence of febrile neutropenia in patients receiving chemotherapy. ]]> <![CDATA[Sun Pharma posts net profit of Rs 20,588 M in Q3FY22]]> https://biospectrumindia.com/news/95/20509/sun-pharma-posts-net-profit-of-rs-20588-m-in-q3fy22.html https://biospectrumindia.com/news/95/20509/sun-pharma-posts-net-profit-of-rs-20588-m-in-q3fy22.html Mon, 31 Jan 2022 15:25:00 +0530 Sun Pharmaceutical Industries has reported financials for the third quarter ending December 31, 2021. In Q3FY22, the consolidated sales from operations was at Rs 98,142 million, growth of 11 per cent over Q3 last year. The India formulation sales was at Rs 31,676 million, up 15 per cent over the same quarter last year. The US formulation sales was at $ 397 million, a growth of 6 per cent over Q3 last year. The Emerging Markets formulation sales was at $239 million, up by 17 per cent over Q3 last year. The Rest of World formulation sales was at $181 million, up by 3 per cent over same quarter last year. The R&D investments was at Rs 5,471 million compared to Rs 5,595 million for Q3FY21. The EBITDA was at Rs 25,574 million, up by about 8 per cent over Q3 last year, with EBITDA margin at 26.1 per cent. The net profit for the quarter was at Rs 20,588 million, up 11 per cent YoY.    In 9mFY22, the consolidated sales from operations was at Rs 290,403 million, a growth of 17 per cent over the same period last year. EBITDA wa at Rs 78,900 million up about 27 per cent over 9m last year, with EBITDA margin at 27.2 per cent.  ]]> <![CDATA[Waters earns top score in Human Rights Campaign Foundation’s LGBTQ+ workplace equality]]> https://biospectrumindia.com/news/95/20479/waters-earns-top-score-in-human-rights-campaign-foundations-lgbtq-workplace-equality.html https://biospectrumindia.com/news/95/20479/waters-earns-top-score-in-human-rights-campaign-foundations-lgbtq-workplace-equality.html Fri, 28 Jan 2022 14:10:00 +0530 Waters Corporation has received a score of 100 on the Human Rights Campaign Foundation’s 2022 Corporate Equality Index (CEI), measuring corporate policies and practices related to LGBTQ+ workplace equality.   Dr Udit Batra, Waters President and CEO, Waters said, "We will continue to challenge ourselves as an organisation and expand our efforts to support and advocate for inclusivity within and beyond the walls of our labs and offices and out into our communities around the world.”   The company recently hired a new head of Diversity, Equity, and Inclusion to continue helping Waters reach its ultimate goal of being representative of the society we live in. In 2022, Waters will continue to build on its internal and external programmes and initiatives that have contributed to the recognition of Waters as one of the Best Places to Work for LGBTQ+ Equality. These programmes include growing a Supplier Diversity Program that incorporates more diverse suppliers such as minority and veteran-owned businesses in all corporate contracting and procurement initiatives and diversifying employee recruitment initiatives.   .   ]]> <![CDATA[Lupin in promotional agreement with Exeltis for SOLOSEC]]> https://biospectrumindia.com/news/95/20475/lupin-in-promotional-agreement-with-exeltis-for-solosec.html https://biospectrumindia.com/news/95/20475/lupin-in-promotional-agreement-with-exeltis-for-solosec.html Fri, 28 Jan 2022 08:40:00 +0530 Lupin Pharmaceuticals and Exeltis USA announced a promotional agreement for Exeltis to promote SOLOSEC along with Exeltis’ existing line of Women’s Health products, further enhancing value to OBGYNs and their patients. SOLOSEC is indicated for the treatment of Bacterial Vaginosis in adult women (a common vaginal infection) and Trichomoniasis in adults (the most common non-viral, curable sexually transmitted infection in the US).“The partnership will expand the reach of SOLOSEC, allowing more Healthcare Providers to be aware of the benefits of SOLOSEC, and increase access for adult women suffering from bacterial vaginosis and adults with trichomoniasis,” said Vinita Gupta, CEO, Lupin. ]]> <![CDATA[Sun Pharma launches dry eye treatment with NCELL tech in Canada]]> https://biospectrumindia.com/news/95/20467/sun-pharma-launches-dry-eye-treatment-with-ncell-tech-in-canada.html https://biospectrumindia.com/news/95/20467/sun-pharma-launches-dry-eye-treatment-with-ncell-tech-in-canada.html Thu, 27 Jan 2022 11:00:00 +0530 Sun Pharma Canada, a wholly-owned subsidiary of Sun Pharmaceutical Industries announced the launch of CEQUA, a new treatment for Canadians living with dry eye disease. CEQUA (cyclosporine ophthalmic solution 0.09 per cent w/v), a calcineurin inhibitor immunomodulator, is the first dry eye treatment available in Canada that is delivered with nanomicellar (NCELL) technology, which improves the bioavailability and physicochemical stability of cyclosporine to increase ocular tissue penetration.   Abhay Gandhi, CEO, North America, Sun Pharma. “This launch is an important milestone for Sun Pharma as we expand our ophthalmics portfolio into Canada and it demonstrates our commitment to providing innovative medicines to support patient and physician choice.”    “We are delighted to see a new product now available to the many Canadians suffering from keratoconjunctivitis sicca or dry eye disease,” said W Bruce Jackson, MD, former Professor and Chair, Department of Ophthalmology, McGill University and University of Ottawa.    ]]> <![CDATA[Guerbet highlights use of Lipiodol for liver cancer treatment in India]]> https://biospectrumindia.com/news/95/20472/guerbet-highlights-use-of-lipiodol-for-liver-cancer-treatment-in-india.html https://biospectrumindia.com/news/95/20472/guerbet-highlights-use-of-lipiodol-for-liver-cancer-treatment-in-india.html Thu, 27 Jan 2022 00:00:00 +0530 Guerbet, headquartered in France, hosted its first India virtual media roundtable, titled ‘Guerbet in India and 100 Years & Beyond of Lipiodol’. Lipiodol is internationally recognized as one of the foremost ethiodized oil that has transformed lives and contributed to huge advances in the treatment of major diseases and debilitating conditions. In India, the drug has been used in fighting liver cancer and disease for decades and continues to make contributions to the management of various diseases. Lipiodol is a pale yellow/amber-coloured, oil-based, radiopaque contrast agent consisting of iodine that is organically combined with ethyl esters of fatty acids of poppy seed oil. In 2019, the company received an approval for a new indication for Lipiodol Ultra Fluid in India for chemoembolization (cTACE) of tumors in adults with known intermediate-stage hepatocellular carcinoma (HCC). HCC is the most common primary liver cancer and is the 4th leading cause of annual cancer death worldwide. Lipiodol Ultra Fluid is used for cTACE, a minimally invasive procedure which consists of mixing Lipiodol Ultra Fluid with an anticancer drug.  Addressing the cost-related concern of this treatment, Dr Vimal Someshwar, Head of Department, Intervention & Diagnostic Radiology, at the Kokilaben Dhirubhai Ambani Hospital and Medical Research Institute stated that it is considered to be a cost-effective treatment in India. In addition, Ghosh TP, General Manager, Guerbet, India outlined Guerbet’s business in India which set up the inauguration of Guerbet India’s Head Office in Mumbai in October 2021. ]]> <![CDATA[Cipla posts PAT of Rs 729 Cr in Q3 FY22]]> https://biospectrumindia.com/news/95/20463/cipla-posts-pat-of-rs-729-cr-in-q3-fy22.html https://biospectrumindia.com/news/95/20463/cipla-posts-pat-of-rs-729-cr-in-q3-fy22.html Wed, 26 Jan 2022 09:55:00 +0530 Cipla announced its unaudited consolidated financial results for the quarter ended December 31, 2021. Income from operations has been registered at Rs 5479 crore, EBITDA at Rs 1243 crore and PAT at Rs 729 crore.   The overall India business grew by 13 per cent YoY led by sustained momentum across core therapies and traction in flagship brands; modest contribution from the covid portfolio. The South Africa private business grew 16 per cent YoY growth in ZAR terms; maintains market-beating trajectory in secondary terms. The US business reported $150 million in revenue.   "Our EBITDA margins for the quarter came in at 22.7 per cent and given the YTD traction, we are well placed to close the year in line with our guidance of 22 per cent. We continue our efforts to improve patient access for therapies including covid products and ensuring adequate supply across all our markets," said Umang Vohra, MD and Global CEO, Cipla. ]]> <![CDATA[Torrent Pharma registers PAT of Rs 249 Cr in Q3 FY 22]]> https://biospectrumindia.com/news/95/20462/torrent-pharma-registers-pat-of-rs-249-cr-in-q3-fy-22.html https://biospectrumindia.com/news/95/20462/torrent-pharma-registers-pat-of-rs-249-cr-in-q3-fy-22.html Wed, 26 Jan 2022 09:45:00 +0530 Torrent Pharma has recently announced the Q3 FY22 results. The company has registered revenue at Rs 2,108 crores up by 6 per cent. The gross margins are at 70 per cent, EBITDA margins at 28 per cent. The EBITDA is at Rs 585 crores was down by five per cent. The profit before tax is at Rs 357 crores and net profit after tax is at Rs 249 crores, down by 16 per cent.Samir Mehta, Chairman, Torrent Pharma said, "Due to the prolonged delays in reinspection of our US facilities on account of the pandemic, coupled with higher than anticipated pricing pressure, our US business has been adversely affected during this quarter. We remain hopeful of our prospects in the US market as soon as the facilities are reinspected. We have initiated cost optimisation measures which should help us get back on track with respect to margins in the upcoming quarters. Our India business continues to be on a strong footing delivering significantly higher than market growth during the quarter.” ]]> <![CDATA[TrueProfile.io unveils career platform for healthcare professionals]]> https://biospectrumindia.com/news/95/20447/trueprofile-io-unveils-career-platform-for-healthcare-professionals.html https://biospectrumindia.com/news/95/20447/trueprofile-io-unveils-career-platform-for-healthcare-professionals.html Mon, 24 Jan 2022 17:05:00 +0530 Dubai-based TrueProfile.io, the online career hub for healthcare professionals, has unveiled the latest addition to the blockchain-powered career platform for healthcare workers called TrueProfile.io Jobs in India. The platform is aimed at helping Indian healthcare professionals find job opportunities abroad.   The platform also offers comprehensive career resources like a free digital CV and access to recruiters worldwide. Some of the top international markets that have huge potential for Indian healthcare professionals are the UK, Ireland, the Kingdom of Saudi Arabia, and the UAE.   With the ongoing pandemic, the need for healthcare professionals has grown multifold and medical recruiters, employers, hospitals and clinics have amplified their hiring efforts on a global scale. TrueProfile.io has partnered with healthcare industry leaders to fulfil the rising requirement for skilled talent in the face of the global pandemic.        ]]> <![CDATA[GSKAPL to acquire trademarks pertaining to Iodex, Ostocalcium brands in India]]> https://biospectrumindia.com/news/95/20434/gskapl-to-acquire-trademarks-pertaining-to-iodex-ostocalcium-brands-in-india.html https://biospectrumindia.com/news/95/20434/gskapl-to-acquire-trademarks-pertaining-to-iodex-ostocalcium-brands-in-india.html Mon, 24 Jan 2022 12:05:00 +0530 The Competition Commission of India (CCI) approves acquisition by GlaxoSmithKline Consumer Healthcare Overseas Limited and GlaxoSmithKline Consumer Healthcare UK Trading Limited (Acquirers) of shareholding in GlaxoSmithKline Asia Private Limited (Target) under Section 31(1) of the Competition Act, 2002.   The proposed combination involves the collective acquisition of 100 per cent shares of Target by the Acquirers. Further, before the proposed combination, GSKAPL will acquire the trademarks of 'Iodex' and 'Ostocalcium' brands in India along with the legal, economic, commercial and marketing rights of such brands and other associated assets (GSK Consumer Brands) from GlaxoSmithKline Pharmaceuticals.    GlaxoSmithKline Consumer Healthcare Overseas is a wholly-owned subsidiary of GlaxoSmithKline Consumer Healthcare Holdings (No.2) Limited (GSK CH HoldCo). It is a part of the overall GlaxoSmithkline (GSK) group and its principal activity is to act as an investment holding company for GSK CH HoldCo and its subsidiaries.    GlaxoSmithKline Consumer Healthcare UK Trading is a part of the overall GSK group and is a wholly-owned subsidiary of GSK CH HoldCo. It is engaged in the distribution and sale of consumer healthcare products, manufacturing, marketing, providing management services to the consumer healthcare group and providing research and development services to other consumer healthcare companies within the GSK group. GSKAPL is a consumer healthcare company that is engaged in the marketing and distribution of oral healthcare products under various brand names such as Sensodyne, Parodontax, Polident and over-the-counter medicines products under the brand names such as Crocin, ENO. ]]> <![CDATA[Biocon posts Q3FY22 revenue at Rs 2,223 Cr]]> https://biospectrumindia.com/news/95/20421/biocon-posts-q3fy22-revenue-at-rs-2223-cr.html https://biospectrumindia.com/news/95/20421/biocon-posts-q3fy22-revenue-at-rs-2223-cr.html Fri, 21 Jan 2022 11:30:00 +0530 Biocon announced its consolidated financial results for the third quarter ended December 31, 2021.   Kiran Mazumdar-Shaw, Executive Chairperson, Biocon, said, “Biocon’s consolidated Q3FY22 revenues grew by 18 per cent YoY to Rs 2,223 crore, driven by a strong performance across all business segments. Biosimilars grew by 28 per cent to Rs 981 crore, research services was up 10 per cent at Rs 641 crore and generics delivered a 7 per cent growth at Rs 607 crore."   Mazumdar-Shaw added, “EBITDA at Rs 537 Crore grew by 25 per cent, which was impacted by mark-to-market loss attributed to Biocon Biologics’ equity investment in Adagio. Core EBITDA stood at Rs 715 crore with a healthy margin of 33 per cent. PBT for the quarter stood at Rs 269 crore. Adjusted for Adagio related loss, PBT was higher at Rs 346 crore, indicating healthy operating profitability.”   Dr Arun Chandavarkar, MD, Biocon Biologics, said, “Following the landmark approval of our interchangeable bGlargine, the first-ever such biosimilar approval, by the US FDA, we recorded another milestone this quarter with the commercialisation of this product by our partner Viatris in the US." ]]> <![CDATA[Biophore to manufacture indigenous ingredients of Pfizer’s COVID-19 drug]]> https://biospectrumindia.com/news/95/20420/biophore-to-manufacture-indigenous-ingredients-of-pfizers-covid-19-drug.html https://biospectrumindia.com/news/95/20420/biophore-to-manufacture-indigenous-ingredients-of-pfizers-covid-19-drug.html Fri, 21 Jan 2022 10:50:00 +0530 Hyderabad-based Biophore India Pharmaceuticals has developed and started manufacturing the key intermediates of Nirmatrelvir, one of the active ingredients of Paxlovid, the latest anti-COVID-19 therapy, approved by the US FDA through the emergency use authorisation route. The manufacturing is being done in collaboration with Rakshit Group. This is expected to greatly reduce the dependence on imports, mainly from China, from where these intermediates are being procured currently. Biophore is also manufacturing Nirmatrelvir in a US FDA compliant facility and has announced that they will be filing for approval with DCGI soon.Dr Jagadeesh Babu Rangisetty, CEO, Biophore, says, “As and when the product gets approved in India, we can ensure that the manufacturers of this product can be self-reliant from within India itself and not be dependent on imports, which can be tricky in terms of control of quality and supply.”Rameswara Rao Chandana, Chairman, Rakshit Group, says, “ Manufacturing of these intermediates requires extreme temperatures and large volumes of Lithium reagents and with the above infrastructure that we have, we are well placed to ensure that the requirements for the market can be met locally. With a strong partner such as Biophore, we believe this is a perfect synergy to get these products to the market quickly.” ]]> <![CDATA[Novo Nordisk India launches oral formulation to treat diabetes]]> https://biospectrumindia.com/news/95/20410/novo-nordisk-india-launches-oral-formulation-to-treat-diabetes.html https://biospectrumindia.com/news/95/20410/novo-nordisk-india-launches-oral-formulation-to-treat-diabetes.html Thu, 20 Jan 2022 16:25:00 +0530 Novo Nordisk India has launched the world’s first and only 'peptide in a pill,' oral semaglutide, a gamechanger in diabetes management. Semaglutide, a GLP-1 receptor analogue (GLP-1 RA) – one of the drug classes to treat diabetes, till now was available only in the form of injections. This is the first time a GLP-1 RA has been developed in an oral formulation.    Novo Nordisk invested 15 years of continuous research, innovation, and development to make the oral formulation of semaglutide into a reality. Due to this scientific breakthrough, it received the Prix Galien Award in 2020, a prestigious award in the industry, for the best biotech innovation.   It has undergone 10 rigorous Phase 3a clinical trials called PIONEER, across several countries including India. The completed and ongoing global trials with oral semaglutide includes more than 10,000 patients of which more than 1,000 participants are from India. In addition to the unprecedented glycemic control, oral semaglutide demonstrated unsurpassed weight loss and consistent cardiovascular safety in clinical trials. Oral semaglutide has been approved by the Drugs Controller General of India (DCGI) in 2020.  ]]> <![CDATA[ENTOD Pharma introduces saffron-based eye care product]]> https://biospectrumindia.com/news/95/20408/entod-pharma-introduces-saffron-based-eye-care-product.html https://biospectrumindia.com/news/95/20408/entod-pharma-introduces-saffron-based-eye-care-product.html Thu, 20 Jan 2022 14:50:00 +0530 ENTOD Pharmaceuticals has come up with a saffron-based eye care supplement, MACUSAFF capsule in India. Manufactured from 100 per cent DNA certified Persian origin natural saffron extract with guaranteed 5 per cent crocins and specially imported from France. This natural eye supplement helps with various eye conditions like age-related macular degeneration, glaucoma, diabetic retinopathy and retinitis pigmentosa.Nikkhil K Masurkar, Executive Director, ENTOD Pharmaceuticals said “ Our saffron-based MACUSAFF veg capsule improves retinal flicker sensitivity, blood flow, protects RGC, reduce intraocular pressure and supports natural mechanisms of the eye.” ]]> <![CDATA[Syngene registers 10% growth in revenue from operations to Rs 6,414 M in Q3]]> https://biospectrumindia.com/news/95/20404/syngene-registers-10-growth-in-revenue-from-operations-to-rs-6414-m-in-q3.html https://biospectrumindia.com/news/95/20404/syngene-registers-10-growth-in-revenue-from-operations-to-rs-6414-m-in-q3.html Thu, 20 Jan 2022 11:15:00 +0530 Syngene International announced its third-quarter results. The company reported revenue from operations growth of 10 per cent year-on-year to Rs 6,414 Mn, delivering 10 per cent growth in profit before tax to Rs 1,284 million. Profit after tax for the quarter was Rs 1,040 million, representing year-on-year growth of 2 per cent. Growth in profit after tax was impacted by a lower effective tax rate in the third quarter last year due to a tax reversal and other factors.    For the nine months to December 31 2021, the company delivered growth of 21 per cent in revenue from operations to Rs 18,461 million and profit after tax, before exceptional items, was Rs 2,733 million, an increase of 12 per cent compared to the same period in the previous year. Based on the company’s performance to date and the anticipated project deliveries in the fourth quarter, the company updated the full-year revenue growth guidance to high teens, from the mid-teen guidance shared at the beginning of the financial year.      ]]> <![CDATA[Glenmark Specialty in exclusive licensing agreement with Lotus International]]> https://biospectrumindia.com/news/95/20403/glenmark-specialty-in-exclusive-licensing-agreement-with-lotus-international.html https://biospectrumindia.com/news/95/20403/glenmark-specialty-in-exclusive-licensing-agreement-with-lotus-international.html Thu, 20 Jan 2022 11:00:00 +0530 Glenmark Pharmaceuticals announced that its Swiss subsidiary, Glenmark Specialty, has entered into an exclusive licensing agreement with Lotus International, a wholly-owned subsidiary of Lotus Pharmaceutical Co, for commercialising its innovative nasal spray Ryaltris in Singapore, Hong Kong and Vietnam.Under the terms of the agreement, Glenmark will be responsible for the manufacture and supply of RyaltrisTM, whereas Lotus will be responsible for the commercialisation of RyaltrisTM (subject to receipt of regulatory approvals), in these markets. Glenmark will receive an upfront payment as well as regulatory and sales-based milestone payments from Lotus."The partnership will provide patients access to a highly effective and proven treatment for allergic rhinitis in these key South-East Asian markets,” said Robert Crockart, Chief Commercial Officer, Glenmark Pharmaceuticals.Petar Vazharov, CEO, Lotus said, “The partnership not only strengthens the competitiveness of our overall product portfolio but also accelerates our expansion in key SEA countries.” ]]> <![CDATA[Mankind Pharma ensuring complete digital experience in partnership with Agilent]]> https://biospectrumindia.com/interviews/95/20414/mankind-pharma-ensuring-complete-digital-experience-in-partnership-with-agilent.html https://biospectrumindia.com/interviews/95/20414/mankind-pharma-ensuring-complete-digital-experience-in-partnership-with-agilent.html Thu, 20 Jan 2022 00:00:00 +0530 In conversation with Samir Vyas (R), India Country General Manager, Agilent Technologies and Rahul Dev (L), Head & VP Analytical Research, Mankind Pharma   Edited excerpts- How was the 'digital transformation' business at Agilent India in 2021? Samir Vyas- Agilent has had a remarkable year in 2021, not just in terms of overall business performance, but also in terms of digital transformation. Our laboratory informatics solutions, such as chromatography data systems and data management, have seen consistent growth, allowing customers to take advantage of Agilent's new generation of informatics solutions. Our customers have consistently requested that we integrate their existing software systems; this is where OpenLab Sample Scheduler came into play, enabling our customers to have a bidirectional LIMS and OpenLab CDS integration for a fully digital experience. Agilent SLIMS & LIMS+ELN solutions were added to our portfolio, providing customers with comprehensive end-to-end solutions from Agilent.   How do you foresee the growth & challenges of 'lab automation' in the pharma industry in India in 2022 & beyond? Samir Vyas- The laboratory informatics market in India is expected to expand at an 11-12 percent CAGR over the next few years. The increasing need for laboratory digitization, the need for integrated lab informatics solutions, and the increasing demand to comply with regulatory requirements are driving the growth. The pandemic has also highlighted the importance of going digital, as there is a need to reduce lab footprints and allow users to work remotely. Every lab needs to get the most out of its resources while keeping operational costs low without compromising the quality of work produced. This is where lab automation comes in, providing maximum productivity and reducing rework. Laboratory operations are extremely complex and heterogeneous because they are frequently managed using a variety of tools. No two labs operate in the same way, and it takes time to translate the complexity of a problem into an electronic or digital solution. The laboratories' replacements could be a variety of digital systems, which are becoming more reliant on greater integration. Integrating these systems has proven to be one of the most time-consuming and frustrating tasks. Agilent is well-known for its robust analytical instruments, and with the addition of easily integrated systems such as Agilent SLIMS, CDS, and ECM, our customers can obtain an end-to-end solution for their lab automation requirements. We have worked on providing solutions that can synchronously “talk” to each other enabling users to have a complete digital experience.   Is the concept of lab automation more popular in the industry or academia sector in India? Samir Vyas- The goal of lab automation is to increase productivity while simultaneously lowering operating costs. Even though the concept of lab automation is arguably more applicable within commercial industries, many academia labs would also benefit from automation in order to further advance and investigate new research concepts whilst educating students using the latest technologies.   Tell us about your partnership with Mankind Pharma. Samir Vyas- Agilent’s partnership with Mankind has been very unique where we supply our analytical instruments for their R&D and QC facilities. With the inclusion of Agilent informatics solutions at Mankind, we are collaborating together on how Agilent can be a part of Mankind’s success in achieving their goal of digitization.   Turning to Rahul Dev, tell us about your partnership with Agilent. Rahul Dev- Agilent has provided us with cutting-edge analytical instruments. We also purchased Agilent software, such as the OpenLab CDS server, and began performing auto calculations on it. OpenLab CDS auto calculations improved operational efficiency because no data had to be manually transcribed to excel, saving analyst and reviewer time, and ensuring a significant reduction in errors associated with manual transcriptions. We are also excited to take advantage of the readily available bidirectional integration of OpenLab CDS and SLIMS, which provides a complete solution from sample management to results transfer from LIMS to OpenLab CDS and vice versa, ensuring a complete digital experience.   How well equipped are you to adapt to lab automation/digital transformation for the pharma business? Rahul Dev- Mankind is well positioned and equipped for the digital transformation journey because we have very well-defined procedures, and the next step is to automate as many of our processes as possible. We've invested in analytical tools and software systems to speed up the digital transformation process.   Which activities would be directed under lab automation? Rahul Dev- Digital transformation is not something that can be accomplished overnight. It is a continuous process of identifying and resolving limiting steps in your process. For example, instead of using Excel spreadsheets, why not perform your calculations within the instrument control software. We began by using auto calculations in OpenLab CDS, which eliminated the need for data to be manually transcribed to excel. The next logical step would be to use LIMS to digitize the sample management process and integrate LIMS with our existing CDS systems to eliminate all manual transcription work. Finally, because data and knowledge are byproducts of all digital systems, consolidating data from disparate sources and storing it for the long term is a critical step in the digital transformation process.   Would you be hiring skilled labor or conducting training programs for the same? Rahul Dev- The lab workforce or end users are the focal point of any digital transformation process. Any digital system should be intuitive and simple to use so that lab users can use it with ease and with minimal training. It should simplify lab users' daily lives and reduce repetitive tasks, allowing them to focus on science rather than processes. We are holding regular training sessions for our employees on new platforms so that they can complete their tasks quickly and thus improve productivity. Also, hiring is a continuous process, and we are looking for skilled labor with the ability to work in a digital environment and contribute to the achievement of company goals.   How much investment would be required to embed lab automation within the pharma business? Rahul Dev- Although it needs some amount of investment in terms of both time and money for the lab automation process, the return on investment is visible in terms of productivity, reduced compliance risk and overall benefit to the organization.     ------------   Dr Manbeena Chawla (manbeena.chawla@mmactiv.com)  ]]> <![CDATA[Mankind Pharma forays in critical care]]> https://biospectrumindia.com/news/95/20398/mankind-pharma-forays-in-critical-care.html https://biospectrumindia.com/news/95/20398/mankind-pharma-forays-in-critical-care.html Wed, 19 Jan 2022 18:00:00 +0530 Mankind Pharma has announced its foraying into critical care. The company has launched Saviour Mankind, a dedicated division for life-saving injectables. The division has commenced operation with products ranging from Anti-infectives to Stroke & Trauma Management.   Through Saviour Mankind, the company will also introduce certain ‘1st time in India’ products which will provide additional armamentarium for Doctors and complement their efforts in tackling the challenges posed by increasing rates of antimicrobial resistance in India.   With this new division, Mankind Pharma is all set to partner with Doctors and ICU staff in their everyday practice. Frequent stock-outs of critical-care products during the COVID-19 pandemic is said to have urged Mankind Pharma to step in and support the medical fraternity with products that are vital in the resuscitation of critically ill patients.   ]]> <![CDATA[Lupin signs first partnership agreement with Foncoo for China]]> https://biospectrumindia.com/news/95/20385/lupin-signs-first-partnership-agreement-with-foncoo-for-china.html https://biospectrumindia.com/news/95/20385/lupin-signs-first-partnership-agreement-with-foncoo-for-china.html Wed, 19 Jan 2022 11:45:00 +0530 Lupin has entered into a partnership with Shenzhen Foncoo Pharmaceutical Co Ltd (Foncoo). This is Lupin’s first partnership arrangement in China and reinforces Lupin’s commitment to bringing high quality generic and complex generic medicines to patients around the world.   Dr Fabrice Egros, President – Growth Markets, Lupin said, “Lupin continues to invest in key growth markets. With China’s growing commitment to affordable and accessible healthcare, Lupin is committed to serving the healthcare needs of the Chinese population by providing high quality generic and complex generic products. We are very excited about our partnership with Foncoo. We will continue exploring additional partnership opportunities in China to leverage our global portfolio including complex generics and specialty medicines.”   Peng Yan, General Manager, Foncoo said, “Foncoo’s successful experiences on importing registration and marketing of the generic formulations and Lupin’s strong capability of making high-quality medicines make our perfect match to each other and our collaboration will have a bright future most likely. We expect that the successful launch of our first product in China will come smoothly and soon. We will also continue exploring more opportunities to work with Lupin for providing more and more high-value and complex medicines to the Chinese physicians and patients.” ]]> <![CDATA[Lord’s Mark Industries invests Rs 100 Cr in preventive healthcare]]> https://biospectrumindia.com/news/95/20381/lords-mark-industries-invests-rs-100-cr-in-preventive-healthcare.html https://biospectrumindia.com/news/95/20381/lords-mark-industries-invests-rs-100-cr-in-preventive-healthcare.html Tue, 18 Jan 2022 00:00:00 +0530 Lord’s Mark Industries has launched the ‘The Hygiene India’ initiative. It will invest Rs 100 Crores in the expansion of the same. The Initiative is to highlight the importance of preventive wellness among the general masses. Through its health and hygiene e-commerce platform-The Hygiene India, LordsMed, the healthcare vertical of Lord’s Mark Industries is offering a holistic range of healthcare, personal and home hygiene products. Produced from natural ingredients and based on indigenous expertise, these products aim to promote best hygiene practices among people and ensure their good health and general well-being. Launched under three brand names- SafeSehat for healthcare, Markosafe for home care and Safelite for sanitary pads- the products have been curated by LordsMed. The current product portfolio of the company comprising 8-10 products under each brand category is planned to be expanded to 25-30 products in the near future. These products would include baby diapers, condoms, bamboo products and travel hygiene kits. Moto is to have essential hygiene kits (Male hygiene kit, Female Hygiene kit, Daily Hygiene kit, Travel kits etc)      ]]> <![CDATA[Dhoot Transmission launches healthcare venture Burge Electronics]]> https://biospectrumindia.com/news/95/20373/dhoot-transmission-launches-healthcare-venture-burge-electronics.html https://biospectrumindia.com/news/95/20373/dhoot-transmission-launches-healthcare-venture-burge-electronics.html Mon, 17 Jan 2022 15:05:00 +0530 Dhoot Transmission, a global automotive components manufacturer with a presence in six countries, has launched a venture christened Burge Electronics as it embarks on a diversification plan to establish its presence in the fast-growing health and wellness industry.   Burge Electronics, which means guarantor in German, will roll out a series of world-class health and wellness products to deliver a truly healthy lifestyle. Banking on DTPL's more than two decades of know-how in product development, manufacturing and distribution, Burge Electronics aims to disrupt the health and wellness industry with safe, affordable, advanced and innovative solutions.    Burge Electronics will soon launch its first product, ion dome, a virus neutraliser approved and tested by ICMR recognised and ILAC accredited labs. Equipped with a unique air purification technology, ion dome comes with an ioniser and disinfects the air in enclosed spaces such as home, office, restaurant, gym, classroom and cabin. The ion dome will make enclosed spaces safe at a time when the country is witnessing rapid spreads of SARS-CoV-2 variants.   ]]> <![CDATA[STFC partners with Skill India to train 1000 drivers transporting oxygen tankers ]]> https://biospectrumindia.com/news/95/20372/stfc-partners-with-skill-india-to-train-1000-drivers-transporting-oxygen-tankers-.html https://biospectrumindia.com/news/95/20372/stfc-partners-with-skill-india-to-train-1000-drivers-transporting-oxygen-tankers-.html Mon, 17 Jan 2022 13:40:00 +0530 Shriram Transport Finance Company (STFC) has partnered with Skill India to train 1000 drivers to ensure seamless and accident-free transportation of oxygen tankers. Intending to streamline Liquid Medical Oxygen (LMO) tankers supply chain amidst the pandemic, Shriram Transport Finance Company has launched a CSR initiative- Shriram Seva Sankalp LMO Driver Training. The campaign aims to upskill 1000 experienced Heavy & Medium Vehicle drivers to carefully handle & transport Cryogenic LMO Tankers.    The Holistic Cryogenic Medical Oxygen Tanker Driver Training Programme will offer the trainees a deep-dive into the theory, hands-on practice on simulator, handling of Hazardous cargo tanker and in-plant LMO loading and unloading along with all other safety precautions to be taken. This will help in creating a pool of skilled drivers to transport cryogenic medical oxygen tankers owing to its growing significance in the medical management of COVID-19 across hospitals. Post the successful completion of the training program, the drivers will be awarded with a certification by Logistics Skill Council.    While over 500 drivers have completed their training in January 2022, the company aims to certify the remaining 500 drivers by March 2022. The shortlisting of experienced heavy motor vehicles (HMV) drivers to enroll for the capacity building training program was conducted at the approved Training Centers funded by Shriram Transport Finance Company Ltd. at multiple locations including Maharashtra, Jharkhand, Gujarat and Tamil Nadu.          ]]> <![CDATA[Parexel bags 'Top CRO to Work With' recognition by WCG CenterWatch survey]]> https://biospectrumindia.com/news/95/20370/parexel-bags-top-cro-to-work-with-recognition-by-wcg-centerwatch-survey.html https://biospectrumindia.com/news/95/20370/parexel-bags-top-cro-to-work-with-recognition-by-wcg-centerwatch-survey.html Mon, 17 Jan 2022 13:30:00 +0530 Parexel has been ranked as the 'Top CRO to Work With' by investigative sites in the 2021 WCG CenterWatch Global Site Relationship Benchmark Survey. The biannual WCG CenterWatch survey explores the relationships among clinical trial sites and their sponsors and CROs and provides insight into overall performance. The 2021 survey asked respondents to evaluate the 35 performance attributes identified by sites as most important to a successful site-CRO working relationship, with Parexel receiving the highest 'excellent' scores across the 35 performance attributes in six working relationship categories among all 29 CROs included in the survey. As part of the survey, sites also rated CROs on their overall reputation in the industry, with Parexel ranking fourth and one of only two to rank in the top five for both industry reputation and direct working relationship quality. Parexel’s performance in the survey further reflects the company’s continued strategic focus in supporting investigative sites to better deliver for patients.  ]]> <![CDATA[Piramal Pharma adds scale roller compactor at Pennsylvania drug product facility]]> https://biospectrumindia.com/news/95/20362/piramal-pharma-adds-scale-roller-compactor-at-pennsylvania-drug-product-facility.html https://biospectrumindia.com/news/95/20362/piramal-pharma-adds-scale-roller-compactor-at-pennsylvania-drug-product-facility.html Fri, 14 Jan 2022 17:35:00 +0530 Piramal Enterprises' Pharma Solutions business, a leading Contract Development and Manufacturing Organization (CDMO), has added development/commercial scale roller compaction technology to its Sellersville, Pennsylvania drug product facility. The addition of the Gerteis Macro-pactor equipment, which is designed to handle both development and commercial-scale roller compaction, enhances the site's dry granulation and scale-up capabilities. Market data indicates that more than 20 per cent of the new chemical entities being developed use roller compaction technology in their development and/or commercialisation. In addition, roller compaction is an excellent technology for processing certain active pharmaceutical ingredients (APIs). The densification of dry blended powders is a critical capability that is required to handle products with poor API flow properties and instances where the API is moisture sensitive. Wet granulation is sometimes used to overcome these challenges, but many APIs are not amenable to wet granulation. In such cases, roller compaction provides a viable option to densify material and generate granules that can be further processed into capsules or tablets.     ]]> <![CDATA[Alkem Labs to launch tech for diabetic foot ulcer management]]> https://biospectrumindia.com/news/95/20341/alkem-labs-to-launch-tech-for-diabetic-foot-ulcer-management.html https://biospectrumindia.com/news/95/20341/alkem-labs-to-launch-tech-for-diabetic-foot-ulcer-management.html Wed, 12 Jan 2022 12:30:00 +0530 Alkem Laboratories has announced to launch a unique patented technology for the treatment of Diabetic Foot Ulcer (DFU) in India. The solution would be based on disruptive 4D Bioprinting technology, which would be used to treat deep, non-healing chronic wounds and is expected to be launched in the Indian market in the latter half of 2022 post regulatory approval.    Alkem has collaborated with South Korea-based Rokit Healthcare to commercialise the technology in India.   The advanced technology for DFU management has a high scope of preventing amputations in diabetic patients. This technology will be available at affordable rates to Indian patients at a time when there is no definitive treatment for DFU in India. ]]> <![CDATA[B Medical Systems opens manufacturing facility in Mundra, Gujarat ]]> https://biospectrumindia.com/news/95/20339/b-medical-systems-opens-manufacturing-facility-in-mundra-gujarat-.html https://biospectrumindia.com/news/95/20339/b-medical-systems-opens-manufacturing-facility-in-mundra-gujarat-.html Tue, 11 Jan 2022 00:00:00 +0530 B Medical Systems, a global leader in medical cold chain solutions, headquartered in Luxembourg, has inaugurated its new Indian manufacturing facility in Mundra, Gujarat in the presence of several national and international dignitaries. Built with an investment of over Rs 100 crore, the facility has an annual production capacity of 100,000 units of medical cold chain products such as vaccine refrigerators, freezers, and transport boxes, which can also be quickly scaled up based on demand. The facility in Mundra is the company’s first-ever manufacturing facility outside Europe and is expected to generate hundreds of employment opportunities in the Kutch region.  Parshottam Rupala, Union Minister of Fisheries, Animal Husbandry & Dairying, Govt of India unveiled the first made in India multi-mode vaccine refrigerator/freezer and/or ice-pack freezer unit of B Medical Systems which will play a big role in enhancing the National Animal Disease Control Programme. B Medical Systems has also announced that the majority of the workforce on the factory floor is comprised of women, towards contributing to women empowerment. ]]> <![CDATA[API-maker Arch Pharmalabs ties up with US-based Orochem Technologies]]> https://biospectrumindia.com/news/95/20323/api-maker-arch-pharmalabs-ties-up-with-us-based-orochem-technologies.html https://biospectrumindia.com/news/95/20323/api-maker-arch-pharmalabs-ties-up-with-us-based-orochem-technologies.html Mon, 10 Jan 2022 13:00:00 +0530 Mumbai-based Arch Pharmalabs has announced the signing of a Technology Access & Services Agreement with Orochem Technologies, USA, on an exclusive basis.   The agreement allows Arch to collaborate with Orochem for using Orochem’s proprietary Simulated Moving Bed (SMB) platform for pharmaceuticals and other applications.    Simulated Moving Bed (SMB) technology is a highly engineered process for implementing chromatographic separation. It is used to separate one chemical compound or one class of chemical compounds from one or more other chemical compounds to provide significant quantities of the purified or enriched material, more cost-effectively than obtained using simple (batch) chromatography. SMB Technology provides for the “highest purities” of industrial or “metric ton” scale purification for API’s, nutritional supplements, fatty acids, and speciality sugars.   Ajit Kamath, Chairman & Managing Director, Arch Pharmalabs Ltd. commented, "The partnership with Orochem provides Arch Pharmalabs vast opportunities for separation and purification of various small molecule Active Pharmaceutical Ingredients from its three USFDA approved facilities in India. It also allows Arch Pharmalabs to collaborate with other pharmaceutical companies to conduct contract manufacturing of APIs at its Vitalife facility in Gurgaon."    ]]> <![CDATA[Lupin launches Molnupiravir under brand name Molnulup]]> https://biospectrumindia.com/news/95/20316/lupin-launches-molnupiravir-under-brand-name-molnulup.html https://biospectrumindia.com/news/95/20316/lupin-launches-molnupiravir-under-brand-name-molnulup.html Fri, 07 Jan 2022 12:35:00 +0530 Lupin has launched Molnupiravir in India under the brand name Molnulup. This drug has been given emergency use authorisation by the Drug Controller General of India (DCGI) for treatment of adult patients with COVID-19, with SpO2 > 93 per cent, and the ones who have a high risk of progression of the disease including hospitalisation.    Internationally, Molnupiravir is an oral antiviral that has been approved by the UK Medicines and Healthcare products Regulatory Agency (MHRA) and the US Food and Drug Administration (FDA) for the treatment of mild-to-moderate cases of COVID-19 in adults.   Administered orally, Molnupiravir inhibits the replication of SARS-CoV-2, the causative agent of COVID-19. Pre-clinical and clinical data have shown Molnupiravir to be effective against the most common SARS-CoV-2 variants including Gamma, Delta, and Mu variants. Molnupiravir should be initiated as soon as possible after a diagnosis of COVID-19 and within five days of onset of symptoms.   ]]> <![CDATA[Bharat Serums and Vaccines opens R&D centre in Airoli, near Mumbai]]> https://biospectrumindia.com/news/95/20315/bharat-serums-and-vaccines-opens-rd-centre-in-airoli-near-mumbai.html https://biospectrumindia.com/news/95/20315/bharat-serums-and-vaccines-opens-rd-centre-in-airoli-near-mumbai.html Fri, 07 Jan 2022 00:00:00 +0530 Bharat Serums and Vaccines (BSV) has opened a world-class R&D centre at Airoli, Maharashtra. The state-of-art centre was inaugurated by Rajesh Tope, Maharashtra's Health Minister. Also present at the event were Sanjiv Navangul, MD & CEO, BSV, Vishwanath Swarup, COO, India Business and Dr Jaby Jacob, Head, R&D.    The R&D centre will endeavour to bring scientifically advanced biological, biotechnology products and novel drug delivery systems that deliver better patient outcomes in women’s health, assisted reproductive technology and critical care and emergency medicines.    Rajesh Tope, Health Minister, State of Maharashtra said, “The collaboration demonstrated by BSV during the pandemic, with the manufacturing of Liposomal Amphotericin B, has helped in saving lives and managing the pandemic.  It is also encouraging to hear of BSV’s ongoing COVID-19 Antibody development that will prepare us to fight the future COVID waves, as we continue to meet the unmet healthcare needs of our people. He added, “With a renewed focus on strengthening women’s health in Maharashtra, we are proud of BSV’s first in the world Anti-Rho (D) immunoglobulin product that has assisted in safe deliveries and in bringing good health to Rh-negative mothers and new-borns in our state. Looking forward, we would like to build a patient-centred, innovation-driven, robust healthcare ecosystem in Maharashtra where companies such as BSV will be able to innovate and bring scientifically advanced products to India and the world.”   ]]> <![CDATA[Aurobindo launches oral COVID-19 drug Molnaflu for adult patients]]> https://biospectrumindia.com/news/95/20309/aurobindo-launches-oral-covid-19-drug-molnaflu-for-adult-patients.html https://biospectrumindia.com/news/95/20309/aurobindo-launches-oral-covid-19-drug-molnaflu-for-adult-patients.html Thu, 06 Jan 2022 11:05:00 +0530 Aurobindo Pharma has made its brand of molnupiravir- Molnaflu available widely in India. Molnupiravir (Molnaflu) is for the treatment of adult patients with COVID-19, with Sp02 >93 per cent and who have a high risk of progression of the disease including hospitalisation or death.   Aurobindo’s brand Molnaflu is now available pan-India across all major metros and towns through its distribution partner.   Molnupiravir was earlier approved under Emergency Use Authorisation from CDSCO, India. This is the first oral antiviral approved by India, the UK agency and also by US Foods & Drugs Administration.     Earlier last year, Aurobindo had signed a bi-lateral non-exclusive voluntary licensing agreement with Merck Sharpe Dohme, Singapore (MSD), a subsidiary of Merck & Co. (US) to manufacture and supply Molnupiravir to over 100 low and middle-income countries (LMIC), including India.   The product will be manufactured at the company’s manufacturing facilities in India that are approved by global regulatory agencies including US FDA and UKMHRA. The company has adequate capacities to meet the global demand across the 100 + LMI Countries for the product.       ]]> <![CDATA[Hamdard launches Roghan Badam Shirin capsules]]> https://biospectrumindia.com/news/95/20307/hamdard-launches-roghan-badam-shirin-capsules.html https://biospectrumindia.com/news/95/20307/hamdard-launches-roghan-badam-shirin-capsules.html Wed, 05 Jan 2022 17:40:00 +0530 Hamdard Laboratories (Medicine Division), has launched capsules of Roghan Badam Shirin in a 100 per cent vegetarian capsule format. The move comes after expanding its OTX range and Unani medicines with 13 product launches.    Hamdard Roghan Badam Shirin Capsules are a healthy blend of the goodness of Unani practice and 100 per cent sweet almond oil. The new format provides health benefits to consumers, but the ease of consumption and carrying the capsules, in a convenient format is its USP. Targeting the digital natives, the benefits of the capsule and the story of the ‘Health on the go’ initiative is told through a creative digital campaign and digital posts. Launched on various platforms, including Hamdard’s social media handles, the company continues to build on its campaign ‘Shine Like No One’ and launched a new digital film to spotlight its USP.   Hamdard Roghan Badam Shirin Capsules are priced at Rs 600 for 60 capsules and are readily available through Modern Trade, Chemists and leading e-com sites including 1 mg, Nykaa, Amazon, Pharmeasy, Healthmug.      ]]> <![CDATA[Cadila Pharma expands oncology portfolio with Tarzed ]]> https://biospectrumindia.com/news/95/20305/cadila-pharma-expands-oncology-portfolio-with-tarzed-.html https://biospectrumindia.com/news/95/20305/cadila-pharma-expands-oncology-portfolio-with-tarzed-.html Wed, 05 Jan 2022 17:25:00 +0530 Ahmedabad-based Cadila Pharmaceuticals has launched Trastuzumab, with the brand name TARZED.   Tarzed is a humanised monoclonal antibody, recommended in HER2 Positive early breast cancer and metastatic breast cancer.   According to the latest audit report of Globocan, Incidences of Breast Cancer are highest among all types of Cancers in the Indian Population.   In a commitment to further strengthening the oncology portfolio Cadila’s TARZED is available as 440 mg injection. The pharma giant has always been focussed on making sure high-quality, affordable, and life-saving treatments are within the reach of patients. TARZED is considered safe and more efficacious compared to conventional treatment medicines for breast cancer.  ]]> <![CDATA[Piramal Pharma Solutions expands in-vitro biology capabilities at Ahmedabad site]]> https://biospectrumindia.com/news/95/20294/piramal-pharma-solutions-expands-in-vitro-biology-capabilities-at-ahmedabad-site.html https://biospectrumindia.com/news/95/20294/piramal-pharma-solutions-expands-in-vitro-biology-capabilities-at-ahmedabad-site.html Tue, 04 Jan 2022 12:50:00 +0530 Piramal Pharma Limited's Pharma Solutions (PPS) business, a leading Contract Research, Development and Manufacturing Organization (CDMO), has made a multi-million dollar investment to create a world-class high-throughput screening facility that will augment the existing in-vitro biology capabilities at its drug discovery services site in Ahmedabad. This new expansion, which is expected to go live in Q3 2022, will significantly add to the primary and secondary screening capabilities of compounds prepared at the Ahmedabad site. The benefits of this new investment will be seen in an improved experience for PPS discovery services customers. With integrated chemistry and biology services now available from a single site, we anticipate significant improvements to drug discovery cycle times. In addition, new personnel with experience in biology services are being added to the site team, complementing the existing technical and operational expertise. The new high-throughput screening technology enables PPS to evaluate and screen 1000 compounds per week using various assay platform technologies such as Fluorescent Imaging Plate Reader (FLIPR), TR-FRET/HTRF, Fluorescence Polarization (FP), absorbance, Luminescence/ Electrochemiluminescence (ECL), Alpha Screen, Lantha Screen, Flow Cytometry, and high content imaging. These platforms will apply to a variety of targets (e.g., G-protein-coupled receptors (GPCRs) and kinase-targeted therapies). Peter DeYoung, CEO, Piramal Pharma Solutions, said, "With this investment, we are enhancing our discovery platform by adding new in vitro biology services to our existing capabilities, making us a more integrated partner."     ]]> <![CDATA[BanyanTree-backed GPT Healthcare gets Sebi nod for Rs 500-crore IPO ]]> https://biospectrumindia.com/news/95/20292/banyantree-backed-gpt-healthcare-gets-sebi-nod-for-rs-500-crore-ipo-.html https://biospectrumindia.com/news/95/20292/banyantree-backed-gpt-healthcare-gets-sebi-nod-for-rs-500-crore-ipo-.html Tue, 04 Jan 2022 10:05:00 +0530 GPT Healthcare, which operates and manages hospitals under the ILS Hospitals brand, has received approval from markets regulator Sebi to launch its initial public offering (IPO).   The initial public offering (IPO) consists of a fresh issue of equity shares aggregating to Rs 17.5 crore, and an offer for sale of up to 29,887,486 equity shares, according to the draft red herring prospectus (DRHP).   As a part of the OFS, BanyanTree Growth Capital II, a Mauritius-based structured private equity, will sell up to 26,082,786 equity shares and GPT Sons, promoter will offload up to 3,804,700 equity shares.   According to market sources, the initial public offering is expected to fetch between Rs 450 crore and Rs 500 crore. At present, GPT Sons Private Limited holds 67.34 per cent stake in GPT Healthcare and BanyanTree Growth Capital II, LLC owns 32.64 per cent stake in the company.   Proceeds from the fresh issue will be used to purchase medical equipment aggregating to Rs 13.2 crore and general corporate purposes.   The Kolkata-based company operates a chain of mid-sized hospitals in eastern India under the 'ILS Hospitals' brand and provides integrated healthcare services, with a focus on secondary and tertiary care. As of September 30, 2021, it operates four multi-speciality hospitals, with a total capacity of 556 beds.   Dam Capital Advisors and SBI Capital Market are the book running lead managers to the IPO.   ]]> <![CDATA[Sun Pharma to set up end-to-end manufacturing facility in AP]]> https://biospectrumindia.com/news/95/20275/sun-pharma-to-set-up-end-to-end-manufacturing-facility-in-ap.html https://biospectrumindia.com/news/95/20275/sun-pharma-to-set-up-end-to-end-manufacturing-facility-in-ap.html Mon, 03 Jan 2022 00:00:00 +0530 Sun Pharmaceutical Industries will be set up a manufacturing facility in Andhra Pradesh (AP). Dilip Shangvi, Founder, Sun Pharma, and his team met with the Chief Minister (CM) of Andhra Pradesh, YS Jagan Mohan Reddy to discuss the progress of the pharmaceutical sector and the setting up an end-to-end manufacturing facility in the state.Shangvi said “I am pleased with the Chief Minister’s understanding of the opportunities and challenges facing the state," and added that the integrated development of the state was becoming clear as part of the Chief Minister’s policy. The CM explained to the team that the steps being taken by the government are for industrial progress and invited them to take advantage of this opportunity and invest in the state. The CM also explained the steps being taken with the aim of integrated development in mind; highly transparent policies are being employed in industries. The state government is determined to make quality human resources available by making skills development/training accessible to all in the state.The opening of this facility will lead to the creation of more jobs and will contribute to the enhancement of the industrial sector in the state. Post the meeting, it was revealed that enhancing the state’s manufacturing capacity and the state government’s ongoing consultations with the relevant authorities, will lead to the company successfully establishing a new industry. The CM told the team that the state would cooperate and support the industries. ]]> <![CDATA[Indira IVF adds two centres in Bengaluru]]> https://biospectrumindia.com/news/95/20287/indira-ivf-adds-two-centres-in-bengaluru.html https://biospectrumindia.com/news/95/20287/indira-ivf-adds-two-centres-in-bengaluru.html Fri, 31 Dec 2021 16:55:00 +0530 Indira IVF added two new centres in Bengaluru’s Kalyan Nagar and Whitefield locations, increasing its presence to 104 hospitals in India. The organisation is also present in JP Nagar, Rajaji Nagar and Indira Nagar, and operates in a hub-and-spoke model to provide ease of access to its patients across the city. The largest infertility treatment provider in the country, Indira IVF is set up in four more centres in Karnataka, including Mysore, Hubli, Gulbarga, and Belgaum. This expansion is a part of its plan to increase its spread across South India.   Dr Kshitiz Murdia – CEO & Co-Founder, Indira IVF said, “Over the next few months, we will inaugurate centres in Tumkuru, Bellary, Raichur, and Davangere. We plan to amplify our footprint in Andhra Pradesh, Telangana, Tamil Nadu, and Kerala subsequently,” he added. ]]> <![CDATA[Mankind Pharma, BDR Pharma launch anti COVID-19 pill Molulife]]> https://biospectrumindia.com/news/95/20280/mankind-pharma-bdr-pharma-launch-anti-covid-19-pill-molulife.html https://biospectrumindia.com/news/95/20280/mankind-pharma-bdr-pharma-launch-anti-covid-19-pill-molulife.html Wed, 29 Dec 2021 15:50:00 +0530 Mankind Pharma and BDR Pharmaceuticals have launched oral anti- COVID pill Molulife (Molnupiravir). The tie-up is a licensing arrangement where production is by BDR Pharma and marketing, selling, promotion, distribution is by Mankind Pharma.    Molnupiravir is an anti-viral drug developed by Merck & Co (known as MSD outside US), in collaboration with Ridgeback Biotherapeutics. It is the first oral anti-COVID pill approved by the UK’s drug regulator-UK Medicines and Healthcare Products Regulatory Agency (MHRA) for the treatment of mild-to-moderate COVID-19 in adults.    Molnupiravir is an orally administered form of a potent ribonucleoside analogue that inhibits the replication of SARS-CoV-2, the causative agent of COVID-19. Molnupiravir targets the SARS-CoV-2 RNA-dependent RNA polymerase (RdRp) the same way other nucleoside analogues do and mediates replication and transcription of the coronavirus genome.   ]]> <![CDATA[Aster Medcity, Kochi launches Aster Heart Rhythm Centre]]> https://biospectrumindia.com/news/95/20276/aster-medcity-kochi-launches-aster-heart-rhythm-centre.html https://biospectrumindia.com/news/95/20276/aster-medcity-kochi-launches-aster-heart-rhythm-centre.html Wed, 29 Dec 2021 12:40:00 +0530 Aster Medcity has launched the Aster Heart Rhythm Centre to cater to treatments for all disorders related to heart rhythms. Dr Praveen Sreekumar, Consultant Electrophysiologist, Aster Medcity, Kochi will take the lead as Director of the Aster Heart Rhythm Centre.   Designed as one of the most advanced facilities of its kind in the region, the Aster Heart Rhythm Centre will ensure timely diagnosis and precise treatment for various disorders related to heart rhythms. Heart arrhythmia treatment includes medications, catheter procedures, implanted devices or surgery to control or eliminate fast, slow or irregular heartbeats. Heart arrhythmias may feel like a fluttering or racing heart and may be harmless. However, some heart arrhythmias may cause bothersome — sometimes even life-threatening — signs and symptoms. ]]> <![CDATA[Serum Institute of India, Novavax receive EUA in India for Covovax]]> https://biospectrumindia.com/news/95/20260/serum-institute-of-india-novavax-receive-eua-in-india-for-covovax.html https://biospectrumindia.com/news/95/20260/serum-institute-of-india-novavax-receive-eua-in-india-for-covovax.html Tue, 28 Dec 2021 00:00:00 +0530 Serum Institute of India (SII) and US-based Novavax, Inc. have received emergency use authorization (EUA) for Novavax' recombinant nanoparticle protein-based COVID-19 vaccine with Matrix-M™ adjuvant by the Drugs Controller General of India (DCGI). The vaccine will be manufactured and marketed in India by SII under the brand name COVOVAX™. Sharing his views, Adar Poonawalla, Chief Executive Officer, Serum Institute of India (SII), said, “The approval of COVOVAX by DCGI is a significant milestone in strengthening our immunization efforts across India and LMICs. We are certain that as the repertoire of the COVID-19 vaccine increases, we will be poised strongly to save the lives of millions of people against the pandemic.” “We expect the authorization of our vaccine to serve a vital need in India, helping to increase the vaccination rate in a country where a significant number of doses is needed to control the pandemic,” said Stanley C. Erck, President and Chief Executive Officer, Novavax.   The Novavax/SII vaccine recently received Emergency Use Listing (EUL) with the World Health Organization (WHO), EUA in Indonesia and the Philippines.  ]]> <![CDATA[Bharat Biotech's Covaxin receives EUA for 12-18 years old]]> https://biospectrumindia.com/news/95/20252/bharat-biotechs-covaxin-receives-eua-for-12-18-years-old.html https://biospectrumindia.com/news/95/20252/bharat-biotechs-covaxin-receives-eua-for-12-18-years-old.html Mon, 27 Dec 2021 00:00:00 +0530 Hyderabad-based Bharat Biotech’s COVID-19 vaccine Covaxin has received the emergency use authorization (EUA) for children of age group 12 to 18 years. Covaxin has established a proven record for safety and efficacy in adults for the original variant and subsequent variants. The company has documented excellent safety and immunogenicity data readouts in children. Bharat Biotech is expecting for COVAXIN to provide similar levels of protection for adults and children alike. ]]> <![CDATA[C Com reinvents social media contextual marketing for Pharma industry]]> https://biospectrumindia.com/news/95/20256/c-com-reinvents-social-media-contextual-marketing-for-pharma-industry.html https://biospectrumindia.com/news/95/20256/c-com-reinvents-social-media-contextual-marketing-for-pharma-industry.html Mon, 27 Dec 2021 00:00:00 +0530 C Com Digital, a Mumbai-based full-service techno digital marketing agency with global footprint, is bringing about a paradigm shift in digital marketing approaches for the Pharma sector. The company has merged advanced technologies such as AI and data analytics with creativity to create new standards of socially relevant, contextual, and engaging marketing content for the Indian Pharma sector. With over 3,000 drug companies and more than 10,500 manufacturing facilities, India is the largest provider of generic medicines worldwide. The Indian pharma companies cater to over 50% of global vaccine demands, and 40% of generic drugs consumed in the US as well as 25% of all medicines in the UK. Alongside such humongous global presence, India also has a massive domestic pharma market. Speaking about this, Chandan Bagwe, Founder / Director, C Com Digital, said, “We can build extensive audiences for our clients through campaigns that are done meticulously with deep research and socially relatable and emotional messaging which the audience connects with. Most importantly, it is easier for sales team of pharma companies to distribute the message and engage with the medical fraternity instantly and they can measure the success of the campaign in real time.” With presence in India, Dubai and US, C Com Digital offers holistic services to its clients by helping them develop AI-powered digital marketing strategies to achieve desired personalization and impact.     ]]> <![CDATA[Clinical study for Itolizumab in Lupus Nephritis starts in India]]> https://biospectrumindia.com/news/95/20241/clinical-study-for-itolizumab-in-lupus-nephritis-starts-in-india.html https://biospectrumindia.com/news/95/20241/clinical-study-for-itolizumab-in-lupus-nephritis-starts-in-india.html Thu, 23 Dec 2021 00:00:00 +0530 US-based Equillium Inc., Biocon’s partner, has expanded its EQUALISE study in Systemic Lupus Erythematosus (SLE) and Lupus Nephritis for Itolizumab (ALZUMAb-L) to clinical centers in India. EQUALISE is a Phase 1b open-label, proof-of-concept clinical study currently studying Lupus Nephritis patients in the Part B portion of the clinical trial. Equillium has initiated this study across several tertiary hospitals specialised to deal with Lupus Nephritis patients in India after obtaining approval from the Drugs Controller General of India (DCGI). Systemic Lupus Erythematosus, or Lupus, is an autoimmune chronic inflammatory disease. The prevalence of SLE in the U.S. has been reported to be between 20 to 150 cases per 100,000. In India, the reported prevalence of SLE is 3.2 per 100,000. Dr Sandeep Athalye, Chief Medical Officer, Biocon Biologics, said: “In India, approximately 45,000 patients are diagnosed with Systemic Lupus Erythematosus (SLE), of which over 20,000 patients have kidney involvement (nephritis), many of which do not respond to standard available therapy with steroids and immunosuppressive drugs.  We believe that ALZUMAb-L (Itolizumab) can address this unmet need for Lupus with better remission rates, more durable responses, and a better safety profile.” ]]> <![CDATA[Transasia Bio-Medicals features in Top 500 annual list by Hurun India]]> https://biospectrumindia.com/news/95/20244/transasia-bio-medicals-features-in-top-500-annual-list-by-hurun-india.html https://biospectrumindia.com/news/95/20244/transasia-bio-medicals-features-in-top-500-annual-list-by-hurun-india.html Thu, 23 Dec 2021 00:00:00 +0530 Mumbai-based in-vitro diagnostic Company Transasia Bio-Medicals has been ranked as one of the top 500 most valuable companies in India. This annual list was recently released by Hurun India in coordination with Burgundy Private and Axis Bank's Private Banking Business. Transasia features in the Top 500 list at the #354 position with an estimated value of Rs 8,900 crore. “Transasia is honoured to be featured in the 2021 list. We are proud to be recognized and featured alongside so many other inspiring, innovative companies that value a workplace culture built on integrity, trust, and compassion,” cited Suresh Vazirani, Founder Chairman, Transasia-Erba Group of Companies. Through its state of the art R&D centres in India, Europe and USA, Transasia has developed world-class technologies for a wide range of disease diagnosis and solutions in Clinical Chemistry, Hematology, Immunology, Diabetes Management, Urinalysis, Coagulation, Critical Care and Molecular Diagnostics.   The companies included in the list of 500 most valuable companies are ranked according to their value, defined as market capitalisation for listed companies and valuations for non-listed companies.   ]]> <![CDATA[Bharat Biotech donates 2,00,000 doses of COVAXIN️ to Republic of Vietnam]]> https://biospectrumindia.com/news/95/20214/bharat-biotech-donates-200000-doses-of-covaxin-to-republic-of-vietnam.html https://biospectrumindia.com/news/95/20214/bharat-biotech-donates-200000-doses-of-covaxin-to-republic-of-vietnam.html Fri, 17 Dec 2021 11:45:00 +0530 The Republic of Vietnam will receive 2,00,000 doses of Bharat Biotech COVAXIN️. Suchitra Ella, Joint MD, Bharat Biotech revealed this at a function hosted by Vuong Dinh Hue, President of the National Assembly of the Socialist Republic of Vietnam in the presence of distinguished dignitaries in New Delhi.The donation represents a gesture of goodwill to provide access to Bharat Biotech WHO approved, indigenously developed COVAXIN️ to fight the COVID-19 Pandemic across borders. COVAXIN️ has received EUL in Vietnam.Bharat Biotech was invited by the Embassy of Vietnam for a one-on-one meeting with the President of the National Assembly, to discuss avenues of cooperation, supplies, and technology transfer possibilities.Bharat Biotech has completed Phase-2 and Phase-3 trials of COVAXIN️ for children in the age group two to 18 years. The data has been submitted to the Central Drugs Standard Control Organisation (CDSCO) and the final approval is awaited. On approval, children will also have access to COVAXIN️.In Vietnam, Bharat Biotech has been working with Duc Minh Medical JSC, towards the commercialisation of INDIRAB (Inactivated Rabies Vaccine). Duc Minh is Bharat Biotech's local partner in Vietnam.Bharat Biotech has also supplied INDIRAB️ to the Republic Nation supporting their national rabies vaccine requirement. ]]> <![CDATA[Zydus receives Orphan Drug Designation from US FDA for malaria drug]]> https://biospectrumindia.com/news/95/20209/zydus-receives-orphan-drug-designation-from-us-fda-for-malaria-drug.html https://biospectrumindia.com/news/95/20209/zydus-receives-orphan-drug-designation-from-us-fda-for-malaria-drug.html Thu, 16 Dec 2021 13:40:00 +0530 Ahmedabad-based Zydus Cadila has announced that its antimalarial compound ZY19489 (MMV253), currently in development together with Medicines for Malaria Venture (MMV), a leading product development partnership (PDP) in antimalarial drug research, has received Orphan Drug Designation from the US FDA.Orphan drug designation provides eligibility for certain development incentives, including tax credits for qualified clinical testing, prescription drug user fee exemptions and seven-year marketing exclusivity upon FDA approval.The Phase I study of ZY19489 has demonstrated a long half-life and potential for a single-dose cure for malaria. In a separate malaria challenge trial, potent antimalarial activity has been demonstrated following single-dose oral administration of ZY19489.Pankaj R Patel, Chairman, Zydus Group said, “ ZY-19489 is a potential single-dose radical cure for P. falciparum and P. vivax malaria which is a major global health risk today." ]]> <![CDATA[Syngene International extends collaboration with Amgen till 2026]]> https://biospectrumindia.com/news/95/20207/syngene-international-extends-collaboration-with-amgen-till-2026.html https://biospectrumindia.com/news/95/20207/syngene-international-extends-collaboration-with-amgen-till-2026.html Thu, 16 Dec 2021 12:45:00 +0530 Syngene International, an integrated research, development and manufacturing services company, announced the extension of its long-standing multi-discipline research collaboration with Amgen, a leading biotechnology company.   The contract is currently extended until the end of 2026 and its scope includes integrated drug discovery and development solutions in discovery chemistry and biology, peptide chemistry, antibody and protein reagents, pharmacokinetics and drug metabolism, and pharmaceutical development.   In addition to operating the existing Syngene Amgen R&D Center (SARC), under the new contract, Syngene will also build and operate a dedicated laboratory.   SARC was established in 2016 and Syngene announced the expansion of the originally dedicated centre in 2017. It currently consists of 60,000 sq ft of floor space and a dedicated team of multi-disciplinary Syngene scientists who work closely with Amgen researchers around the world on the discovery and development of innovative medicines.  ]]> <![CDATA[Glenmark's subsidiary Ichnos Sciences inks agreement with Almirall]]> https://biospectrumindia.com/news/95/20187/glenmarks-subsidiary-ichnos-sciences-inks-agreement-with-almirall.html https://biospectrumindia.com/news/95/20187/glenmarks-subsidiary-ichnos-sciences-inks-agreement-with-almirall.html Tue, 14 Dec 2021 14:25:00 +0530 Glenmark Pharma' subsidiary Ichnos Sciences, a US-based biotechnology company developing innovative biologics in oncology and autoimmune diseases, and Almirall, a global biopharmaceutical company focussed on skin health, have entered into an exclusive licensing agreement for the IL-1RAP antagonist ISB 880. Under the agreement, Almirall is granted global rights to develop and commercialise this monoclonal antibody for autoimmune diseases. Ichnos will retain rights for antibodies acting on the IL-1RAP pathway for oncology indications.Within the terms of the agreement, Almirall will assume full cost and responsibility for the global development and commercialisation of the compound for all autoimmune disease indications. Ichnos will receive an upfront payment of €20.8 million as well as additional development and commercial milestone payments and tiered royalties based upon future global sales.ISB 880 is a first-in-class fully human, high affinity monoclonal antibody that targets human IL-1RAP.  ]]> <![CDATA[Alembic Pharma announces seed round investment in RIGImmune]]> https://biospectrumindia.com/news/95/20174/alembic-pharma-announces-seed-round-investment-in-rigimmune.html https://biospectrumindia.com/news/95/20174/alembic-pharma-announces-seed-round-investment-in-rigimmune.html Fri, 10 Dec 2021 18:15:00 +0530 Vadodara-based Alembic Pharmaceuticals has made a strategic investment in RIGImmune, a biopharmaceutical research company co-founded by two prominent Yale University professors Dr Anna Pyle and Dr Akiko Iwasaki. RIGImmune is focused on the development of RNA based therapies for viral diseases and oncology applications by targeting the innate immune target, RIG-I. RIGImmune will utilise the proceeds of the series seed round to further the development of therapeutic oligonucleotides developed by Dr Pyle and Dr Iwasaki.Alembic has acquired preferred stock in RIGImmune amounting to a 19.97 per cent post-money stake in the first closing of the series seed round that was completed recently. ]]> <![CDATA[Cipla to donate 5000 nebulisers across PHCs in rural India ]]> https://biospectrumindia.com/news/95/20172/cipla-to-donate-5000-nebulisers-across-phcs-in-rural-india-.html https://biospectrumindia.com/news/95/20172/cipla-to-donate-5000-nebulisers-across-phcs-in-rural-india-.html Fri, 10 Dec 2021 17:50:00 +0530 Cipla announced a first-of-its-kind initiative to improve access to nebulisation therapy specifically for patients in the rural sections of the country.    Cipla aims to distribute 5000 nebulizers to primary health care setups in India where nebulisation therapy is not available currently, thus enabling access for the masses. These CHCs (Community Health Centers) /PHCs (Primary Health Centers) across several states in the country namely – Maharashtra, Uttar Pradesh, Rajasthan, West Bengal, Andhra Pradesh, Telangana, Tamil Nadu, Uttarakhand, Punjab, Sikkim will be adopted by Cipla to create good nebulisation centres, spread awareness regarding the therapy and undertake training for the associated paramedical staff on the science of safe nebulisation practices.    Intending to address the low awareness around nebulization in acute disease management, Cipla is also attempting to create a World Record of making the ‘largest nebulizer sentence’ with these 5000 nebulisers. The statement reads ‘Breathe Free.’ and it will be recorded in the Guinness Book of World Records.    ]]> <![CDATA[Lupin plans to set up 100+ diagnostics labs in next three years]]> https://biospectrumindia.com/news/95/20171/lupin-plans-to-set-up-100-diagnostics-labs-in-next-three-years.html https://biospectrumindia.com/news/95/20171/lupin-plans-to-set-up-100-diagnostics-labs-in-next-three-years.html Fri, 10 Dec 2021 17:20:00 +0530 Lupin has announced the launch of Lupin Diagnostics in Navi Mumbai. Spread across 45,000 sq ft, the National Reference Laboratory will provide a comprehensive range of diagnostic tests with a special focus on gynaecological tests. These include molecular diagnostics, cytogenetics, flow cytometry, microbiology, serology, histopathology and cytology, haematology, immunology, amongst others.The lab is NABL accredited and in future will add dermatology and urology to its portfolio. Lupin Diagnostics will conduct tests for covid and is awaiting NABL certification for the same.  Speaking exclusively to BioSpectrum India, Rajeev Sibal, President, India Region Formulations, Lupin said, "Though we are a late entrant in the diagnostics segment, our services will have an impact on the sector." Currently, there are 11 labs operational in the Western and Eastern part of the country and in the coming days the company is likely to foray into the Southern states. Sibal also mentioned that temperature-controlled sample collection kits are being provided to ensure that the samples are intact.Talking about the huge scope in the Indian market, Ravindra Kumar, Vice President & Head, Lupin Diagnostics mentioned, "In the next three years, we plan to set up 100+ labs and 1000+ Lupin Mitras." The company is looking for franchisee partners in Maharashtra, West Bengal, Bihar, Jharkhand and other North-Eastern states.   Sanjiv Das sanjiv.das@mmactiv.com     Image caption- From L to R: Rajeev Sibal, President – India Region Formulations, Lupin and Ravindra Kumar, V.P. & Head – Lupin Diagnostics ]]> <![CDATA[Zydus receives US FDA approval to initiate Phase 2(b)/3 on liver disease]]> https://biospectrumindia.com/news/95/20170/zydus-receives-us-fda-approval-to-initiate-phase-2b-3-on-liver-disease.html https://biospectrumindia.com/news/95/20170/zydus-receives-us-fda-approval-to-initiate-phase-2b-3-on-liver-disease.html Fri, 10 Dec 2021 17:15:00 +0530 Zydus has received permission from the US FDA to initiate the Phase 2(b)/3 Prospective, multi-centre, randomised, double-blind, placebo-controlled adaptive clinical trial to evaluate the efficacy and safety of Saroglitazar Magnesium in Subjects With Primary Biliary Cholangitis (PBC). PBC is a severe liver disease leading to cirrhosis of the liver, liver failure, and possibly death.   The EPICS-IIITM trial will randomise 192 subjects in a 1:1:1 ratio to Saroglitazar 1 mg, Saroglitazar 2 mg or Placebo and will study the Saroglitazar Magnesium (1 or 2 mg) relative to Placebo based on the composite endpoints of Alkaline Phosphatase (ALP), total bilirubin, liver stiffness measurement (LSM) by FibroScan, liver enzyme parameters (ALT, AST, GGT, total bilirubin, and albumin), lipid parameters (TG, LDL-C, HDL-C, VLDL-C, total cholesterol, and non-HDL-C), health-related quality of life using PBC 40 questionnaire (a patient-derived, disease-specific quality of life measure developed and validated for use in PBC) and other outcome measures over 52 weeks.   The EPICS-IIITM Phase 2(b)/3 trial will be led by Prof Naga Chalasani, Interim Chair, Department of Medicine, Indiana University School of Medicine as Principal Investigator.   The Phase 2(a) EPICS trials results published in the Journal of Hepatology has demonstrated that Saroglitazar holds immense potential based on its safety and efficacy profile.  ]]> <![CDATA[Venus Remedies secures approval for govt's PLI scheme]]> https://biospectrumindia.com/news/95/20168/venus-remedies-secures-approval-for-govts-pli-scheme.html https://biospectrumindia.com/news/95/20168/venus-remedies-secures-approval-for-govts-pli-scheme.html Fri, 10 Dec 2021 16:45:00 +0530 Venus Remedies has figured among the select pharmaceutical firms in India which have been picked for the Production-Linked Incentive (PLI) Scheme of the Central government under the Aatmanirbhar Bharat initiative. Under this scheme, Venus Remedies will make a committed investment in plant and machinery, get incentives on incremental sales of pharmaceutical products.   The company, which is entitled to PLI to build on its existing capacities from the financial year (FY) 2022-23 to FY 2027-28, is among the non-MSME pharmaceutical companies which have been granted approval under the PLI Scheme in Category C involving companies with a manufacturing turnover of less than Rs 500 crore.   Stating that the company got the approval as a beneficiary of the PLI Scheme on account of impressive marketing authorisations and dossier wealth in regulated markets, Saransh Chaudhary, President, Global Critical Care, Venus Remedies, and CEO, Venus Medicine Research Centre (VMRC), said, “This is an acknowledgement of our research competencies and manufacturing abilities. We have secured this approval based on our world-class R&D, potential to grow in size and scale using cutting-edge technologies and capabilities to penetrate global value chains.”   The PLI scheme has the potential to contribute significantly to achieving the larger objective of ensuring affordable healthcare in India as well as abroad on a sustained basis. It aims to give impetus to innovation, research and development and widen the product profile of Indian manufacturers.  ]]> <![CDATA[Dr Reddy’s expands biosimilar offerings in Latin America, Southeast Asian countries]]> https://biospectrumindia.com/news/95/20161/dr-reddys-expands-biosimilar-offerings-in-latin-america-southeast-asian-countries.html https://biospectrumindia.com/news/95/20161/dr-reddys-expands-biosimilar-offerings-in-latin-america-southeast-asian-countries.html Thu, 09 Dec 2021 17:15:00 +0530 Dr Reddy’s Laboratories has entered into a binding agreement with Singapore-based Prestige BioPharma for an exclusive partnership for the supply and commercialisation of Prestige BioPharma’s proposed trastuzumab biosimilar in select countries in Latin America and Southeast Asia.   Prestige BioPharma’s trastuzumab (HD201) is a proposed biosimilar to Roche’s Herceptin and can be prescribed for the treatment of HER2 positive breast and metastatic gastric cancer. The license agreement grants Dr Reddy’s the exclusive rights to commercialise the proposed biosimilar in select countries in Latin America and Southeast Asia.  Under this partnership, Prestige BioPharma will be responsible for the sustainable commercial supply of HD201 from its manufacturing facilities in Osong, South Korea, while Dr Reddy’s will be responsible for local registrations, marketing and sales in the licensed territories.   M.V. Ramana, CEO – Branded Markets (India & Emerging Markets), Dr. Reddy’s, said: “This is in line with our stated intention to create a portfolio of oncology products and expand our biosimilar offerings in Emerging Markets.” ]]> <![CDATA[Healthium Medtech opens CDSCO-certified facility near Ahmedabad ]]> https://biospectrumindia.com/news/95/20159/healthium-medtech-opens-cdsco-certified-facility-near-ahmedabad-.html https://biospectrumindia.com/news/95/20159/healthium-medtech-opens-cdsco-certified-facility-near-ahmedabad-.html Thu, 09 Dec 2021 13:45:00 +0530 Bengaluru-based Healthium Medtech has announced the launch of its latest manufacturing facility in Ahmedabad. The facility owned by Uteshiya Medicare is located at the Rohisa Industrial Estate and has been licenced by Healthium Medtech to exclusively manufacture its wide range of Arthroscopy products marketed under the brand Sironix.   The CDSCO- certified facility is spread across 70,000 sq ft. The Ahmedabad facility was inaugurated by Arjunsinh Chauhan, Minister for Rural Housing & Development, Government of Gujarat.   Arthroscopy products are used to help treat various knee and shoulder conditions such as anterior cruciate ligament reconstruction, posterior cruciate ligament injuries and other ligament reconstruction and repair and meniscal repair.  ]]> <![CDATA[Healthium Medtech receives US FDA registration for Sri City manufacturing facility in AP]]> https://biospectrumindia.com/news/95/20153/healthium-medtech-receives-us-fda-registration-for-sri-city-manufacturing-facility-in-ap.html https://biospectrumindia.com/news/95/20153/healthium-medtech-receives-us-fda-registration-for-sri-city-manufacturing-facility-in-ap.html Wed, 08 Dec 2021 15:40:00 +0530 Healthium Medtech has received US FDA (US Food and Drug Administration) registration for its manufacturing facility in Sri City, Andhra Pradesh.    Based on the focus placed on creating high-quality precision-based medical devices, Healthium’s manufacturing facilities are subjected to rigorous quality control checks and periodic inspections from various regulatory agencies across the world. The accreditation of our manufacturing facilities reiterates our focus on patient safety and is an essential requirement for our products to be used in the treatment of patients globally.    Healthium commenced its operations at the Sri City facility in the calendar year 2012. The facility manufactures sutures, meshes with a production capacity of 1.20 million, as per the fiscal of 2021, and is located in a special economic zone (SEZ).    Anish Bafna, CEO and MD said, “We are delighted to receive the US FDA registration for our Sri City facility in Andhra Pradesh, our fourth facility to receive it. This is testimony to our commitment to operational excellence and to our focus on delivering high quality, safe, value-driven products aligned with our vision “Access to precision MedTech for every patient, globally.”       ]]> <![CDATA[SPARC in agreement with Visiox Pharma]]> https://biospectrumindia.com/news/95/20151/sparc-in-agreement-with-visiox-pharma.html https://biospectrumindia.com/news/95/20151/sparc-in-agreement-with-visiox-pharma.html Wed, 08 Dec 2021 15:20:00 +0530 Sun Pharma Advanced Research Company (SPARC) has entered into an agreement with Visiox Pharma (Visiox) to grant exclusive worldwide rights (except for India and Greater China) for the development and commercialization of PDP-716 and SDN-037.  Under the terms of the license agreement, SPARC will be eligible to receive an upfront payment, milestone payments and royalty on sales, in addition to 10 per cent equity in Visiox.  “We are excited to enter into this collaboration. The collaboration with Visiox allows us to make PDP-716 and SDN-037 available to patients seeking to overcome the challenges associated with the currently marketed formulations of these drugs," said Anil Raghavan, CEO, SPARC. Michael Derby, Chairman, Visiox, said, “We are excited to partner with SPARC to register these important products and commercially launch them so that patients may be able to benefit from them as soon as possible. In Visiox, we look forward to building one of the industry’s leading ophthalmics companies.” ]]> <![CDATA[BDR Pharma launches India's first generic Midostaurin for leukemia treatment]]> https://biospectrumindia.com/news/95/20142/bdr-pharma-launches-indias-first-generic-midostaurin-for-leukemia-treatment.html https://biospectrumindia.com/news/95/20142/bdr-pharma-launches-indias-first-generic-midostaurin-for-leukemia-treatment.html Tue, 07 Dec 2021 16:40:00 +0530 Mumbai-based BDR Pharma has announced the launch of India's first generic- Midostaurin under the brand name MSTARIN, which is indicated in rare, hard-to-treat cancers.   The drug is approved for use in combination with standard Daunorubicin & Cytarabine induction and high-dose Cytarabine consolidation chemotherapy, and for patients in complete response followed by Midostaurin single-agent maintenance therapy for adults with newly diagnosed Acute Myeloid Leukemia (AML) who are FLT3 mutation-positive.   The drug will have a strength of 25 mg, in the form of capsules.       ]]> <![CDATA[Wipro GE Healthcare introduces B2B eCommerce platform in India]]> https://biospectrumindia.com/news/95/20139/wipro-ge-healthcare-introduces-b2b-ecommerce-platform-in-india.html https://biospectrumindia.com/news/95/20139/wipro-ge-healthcare-introduces-b2b-ecommerce-platform-in-india.html Tue, 07 Dec 2021 13:35:00 +0530 Wipro GE Healthcare has launched its B2B eCommerce platform, the GE Shop, in India to enable the purchase of medical equipment online. This initiative is aligned to GE’s vision of democratising access and unlocking better value in healthcare systems across all of India along with the commitment to supporting ease of business for hospitals. The platform, which was first launched by GE Healthcare in the US, is designed to offer a depth of reach and a superlative customer experience. Through the GE Shop, Wipro GE Healthcare aims to address the currently underserved tier II & III markets in India. Purchase of MedTech devices requires a considerable amount of research and in-depth product understanding. The next-generation model is designed to solve the elementary issues faced by healthcare professionals and is configured to provide transparent and authentic information. The launch is an extension of GE Healthcare’s online service delivery enterprise Service Shop, a unique e-commerce portal to order genuine parts and accessories and create or renew your service contracts online.  The platform currently offers popular pre-configured products, making it easier for the customers to choose the variant. Healthcare professionals can customise the products and choose add-on accessories to suit their needs.  ]]> <![CDATA[Merck announces season 2 winners of Young Scientist Award in India]]> https://biospectrumindia.com/news/95/20128/merck-announces-season-2-winners-of-young-scientist-award-in-india.html https://biospectrumindia.com/news/95/20128/merck-announces-season-2-winners-of-young-scientist-award-in-india.html Mon, 06 Dec 2021 00:00:00 +0530 Merck has announced the winners of the second 2 of Merck Young Scientist Award. The award intends to recognize and encourage young budding scientists who dream of making a difference in the lives of millions of people across India, through their cutting-edge research in Life Sciences.  Season 1 of Merck Young Scientist Award in 2019 felicitated 11 curious minds for their novel research work. This year company invited applications in three research areas- Biological Sciences, Chemical Sciences & COVID research and received over 2000 registrations with more than 500 applications. The applications were scrutinized by an eminent jury constituted by distinguished scientists and academicians in the country. The winners: Sarit S. Agasti, Jawaharlal Nehru Centre for Advanced Scientific Research, Bengaluru Prakriti Tayalia, Indian Institute of Technology Bombay, Mumbai Kartik Sunagar, Indian Institute of Science, Bengaluru Kanishka Biswas, Jawaharlal Nehru Centre for Advanced Scientific Research, Bengaluru Chandra M. R. Volla, Indian Institute of Technology Bombay, Mumbai Dr Modhu Sudan Maji, Indian Institute of Technology Kharagpur, Kharagpur Debojyoti Chakraborty, CSIR-Institute of Genomics and Integrative Biology, New Delhi The runners-up: Ritobrata Goswami, Indian Institute of Technology Kharagpur, Kharagpur B Anand, Indian Institute of Technology Guwahati, Guwahati Srimonta Gayen, Indian Institute of Science, Bengaluru S. Santhosh Babu, CSIR-National Chemical Laboratory Biplab Maji, Indian Institute of Science Education and Research, Kolkata Mahiuddin Baidya, Indian Institute of Technology Madras, Chennai Rajesh Kumar, Translational Health Science and Technology Institute, Faridabad The winners received cash award of Rs 2,50,000 & Travel Award of Rs 1,00,000 each and the runners up each received cash prize of Rs 1,00,000. Merck Young Scientist Award is a step towards the company’s efforts of nurturing the scientist of tomorrow and fostering a thriving community for advancing science. The award is presented to a Researcher or Scientist with less than 12 years of research experience (post PhD), residing in India and presenting innovative scientific research that can benefit the society. The Jury included eminent scientists from top Indian Academic institutes with Dr Shahid Jameel, visiting Professor, Ashoka University, India and Fellow at OCIS and Green Templeton College, University of Oxford, UK, as the Chair and Dr Anurag Agrawal, Director, Institute of Genomics & Integrative Biology, Prof Apurva Sarin, Director, Institute for Stem Cell Biology and Regenerative Medicine, Dr D. Srinivasa Reddy, Director, CSIR – Indian Institute of Integrative Medicine and Dr Radha Rangarajan, Chief Technology Officer, HealthCube, as Co-Chairs. The award ceremony was held in Chandigarh on November 17, 2021.     ]]> <![CDATA[Lupin signs agreement with Biomm in Brazil]]> https://biospectrumindia.com/news/95/20119/lupin-signs-agreement-with-biomm-in-brazil.html https://biospectrumindia.com/news/95/20119/lupin-signs-agreement-with-biomm-in-brazil.html Fri, 03 Dec 2021 19:05:00 +0530 Lupin has entered into an exclusive distribution and marketing agreement with Biomm in Brazil. Under the terms of the agreement, Biomm will distribute and market biosimilar Pegfilgrastim in Brazil.  Lupin had earlier received the US FDA acceptance of the Biologics License Application (BLA) for its proposed biosimilar to Neulasta (pegfilgrastim) through a filing using the 351(k) pathway.  Pegfilgrastim is indicated to reduce the duration of neutropenia and the incidence of febrile neutropenia in patients receiving chemotherapy. ]]> <![CDATA[SPARC inks agreement with Biomodifying for cancer research]]> https://biospectrumindia.com/news/95/20116/sparc-inks-agreement-with-biomodifying-for-cancer-research.html https://biospectrumindia.com/news/95/20116/sparc-inks-agreement-with-biomodifying-for-cancer-research.html Fri, 03 Dec 2021 17:35:00 +0530 Sun Pharma Advanced Research Company (SPARC) has entered into an agreement with US-based Biomodifying to exclusively license Biomodifying’s intellectual property, including all patents and patent applications, owned or controlled by Biomodifying, along with antibodies developed for multiple uses including for cancer.   Under the agreement, Biomodifying is eligible for an up-front payment, milestone payments on pre-specified clinical, regulatory, and commercial milestones, as well as royalties on sales. In addition, SPARC will pay Biomodifying a percentage of payments received for sublicenses of the licensed IP.  “This is an important milestone for SPARC. The licensing of antibodies from Biomodifying will assist us in our endeavour to transition SPARC into a company focussed on novel treatment modalities, including bi-specific antibodies and antibody-drug conjugates" said Anil Raghavan, CEO, SPARC. ]]> <![CDATA[Morepen bags US FDA approval for allergy drug Allegra]]> https://biospectrumindia.com/news/95/20115/morepen-bags-us-fda-approval-for-allergy-drug-allegra.html https://biospectrumindia.com/news/95/20115/morepen-bags-us-fda-approval-for-allergy-drug-allegra.html Fri, 03 Dec 2021 13:25:00 +0530 Morepen Laboratories has received US FDA approval for its anti-allergy drug Fexofinadine Hydrochloride, marketed in India under the brand name Allegra. The company has already supplied validation quantities and the regular commercial supplies would start after approval of validation batches. Fexofinadine is an established anti-allergy drug with a market size of around 700MT and is expected to give immediate impetus to the company’s export business.   The export of Fexofenadine to the highly regulated US market in Q4’FY22 is expected to see multi-fold growth resulting in better profitability margins for the company. The company is having sufficient capacity to service the present demand and is also expanding capacities to become a leading player in the product in the coming years.   Fexofinadine has marketed primarily in two dosage forms 120mg and 180mg and is available to buy over the counter in many countries including the US, Australia, New Zealand, and certain countries around Europe. It is also used in combination with other anti-allergy drugs like Montelukast for which Morepen has got the largest manufacturing capacity in the world and is already approved in the US market.    The company has reported consolidated profits (before tax) at Rs 46.86 crores in Q2’FY22. Profit after tax (PAT) for the quarter has jumped 38 per cent to Rs 37.36 crores. The quarterly revenues of the company at Rs 398.17 crores have recorded an impressive growth of 17 per cent during the current quarter as compared to quarterly revenues of Rs 340.13 crores in Q2’FY21 where it had registered a growth of 57 per cent. This is the sixth quarter in a row that the company continues the fast growth trajectory with remarkable gains in the bottom line. ]]> <![CDATA[Eris, MJ Biopharm foray into India’s insulin market]]> https://biospectrumindia.com/news/95/20120/eris-mj-biopharm-foray-into-indias-insulin-market.html https://biospectrumindia.com/news/95/20120/eris-mj-biopharm-foray-into-indias-insulin-market.html Fri, 03 Dec 2021 00:00:00 +0530 Eris Lifesciences has announced its entry into India through Eris MJ Biopharm, a special purpose joint venture between Eris and Mumbai- based MJ Biopharm.  The 70:30 Joint Venture (with Eris holding a 70 per cent stake) will primarily engage in marketing and distribution of Human and Analogue Insulin including Aspart, Glargine and Lispro and GLP-1 agonists (e.g., Liraglutide) and potentially other biopharma products in India. MJ Biopharm will be responsible for the development, manufacturing and supply of these products to the JV.  Amit Bakshi, CMD, Eris Lifesciences, said “Given our strong market position in OAD and blockbuster brands like Zomelis and Gluxit, we are well-positioned to ride the growth wave in DPP4-SGLT2 combinations. With the formation of this JV, we will add Human Insulin, Analogues and GLP-1 agonists to our portfolio, which along with our Circa range of Glucometers, CGM Devices and HbA1C monitors, makes us a full-service player in diabetes care.” Amol Shah, MD, MJ Biopharm, said “With proven capabilities in biopharmaceutical development and manufacturing as well as world-class facilities, MJ Biopharm has built strong credibility in the insulin space, with 14+ million vials and 4+ million cartridges of recombinant human insulin manufactured and supplied to 25+ countries since 2015. I am excited about this collaboration with Eris and we look forward to expanding the breadth and depth of the insulin market in India.” ]]> <![CDATA[Premas Biotech, Oravax to test oral vaccine candidate against Omicron]]> https://biospectrumindia.com/news/95/20104/premas-biotech-oravax-to-test-oral-vaccine-candidate-against-omicron.html https://biospectrumindia.com/news/95/20104/premas-biotech-oravax-to-test-oral-vaccine-candidate-against-omicron.html Thu, 02 Dec 2021 13:25:00 +0530 Gurugram-based Premas Biotech has announced that its joint venture Oravax will initiate testing of their oral virus-like particle (VLP) vaccine candidate against Omicron variant of SARS-CoV 2 virus through preclinical, in vitro and challenge studies to assess its efficacy for the new mutant strain.   Premas Biotech, Oramed Pharmaceuticals, MyMD Pharmaceuticals, and certain other shareholders formed Oravax Medical to bring an oral COVID-19 vaccine to the market.    The Oravax oral vaccine candidate has received clearance from the South African Health Products Regulatory Authority to begin enrollment in phase I clinical trials in South Africa.   If approved, Oravax’s oral VLP vaccine candidate would be used either as a standalone vaccine or as a booster for previously vaccinated individuals. The oral method of administration may result in greater safety by reducing potential side effects.   Oravax's vaccine technology is highly scalable for manufacturing and is easily transferable for wide-scale logistical distribution, as there is no need for freezer storage. ]]> <![CDATA[Lupin partners with TTP for soft-mist inhalation tech platform]]> https://biospectrumindia.com/news/95/20103/lupin-partners-with-ttp-for-soft-mist-inhalation-tech-platform.html https://biospectrumindia.com/news/95/20103/lupin-partners-with-ttp-for-soft-mist-inhalation-tech-platform.html Thu, 02 Dec 2021 13:10:00 +0530 Lupin has entered into an agreement with TTP (The Technology Partnership) to acquire the exclusive worldwide rights to develop, manufacture and commercialise inhalation products using TTP’s soft-mist inhalation technology platform. By leveraging this technology, Lupin expects to provide healthcare professionals with alternative solutions for delivering affordable inhaled medicines to patients across the globe.Soft-mist inhalation (SMI) technology allows for the delivery of inhalation drugs from a small, portable hand-held inhaler device without the use of propellants. The individual doses are delivered using a precisely engineered nozzle system to produce a slow-moving and long-sustaining aerosol cloud. Mumbai-based pharma firm Lupin anticipates applications across respiratory care.Lupin and TTP will jointly develop the device. Lupin will commercially manufacture the device through its network of in-house and external manufacturing locations. Lupin will also develop and manufacture formulations to be delivered through the device, obtain the necessary regulatory approvals, and commercialise the products globally. ]]> <![CDATA[Biocon enters Dow Jones Sustainability Emerging Markets Index]]> https://biospectrumindia.com/news/95/20100/biocon-enters-dow-jones-sustainability-emerging-markets-index.html https://biospectrumindia.com/news/95/20100/biocon-enters-dow-jones-sustainability-emerging-markets-index.html Wed, 01 Dec 2021 15:30:00 +0530 Dow Jones Sustainability Index (DJSI) has selected Biocon in the Emerging Markets (EM) category for its progressive Environmental, Social and Governance (ESG) practices, which underscore its commitment to the larger goal of sustainable development. Biocon made a formal submission for Corporate Sustainability Assessment for its listing on the DJSI for the first time this year and made it to the DJSI EM Index with a Total Sustainability Score of 45 as against an industry average of 18, achieving a 93rd percentile position. It is among the Top 15 companies from India and one of the 12 companies from the pharmaceuticals, biotechnology and life sciences sectors to be featured in the index for 2021. A total of 360 Indian companies were invited to participate in DJSI in 2021. Kiran Mazumdar-Shaw, Executive Chairperson, Biocon and Biocon Biologics, said, “Our business purpose is focused on delivering health equity by providing affordable access to life saving and essential medicines to patients across the world. Our entry in the DJSI Emerging Markets Index is a testimony to our responsible and sustainable business practices and our philosophy of putting equity and equality at the centre of everything we do. The DJSI Index provides an important yardstick for Biocon and Biocon Biologics to measure sustainability performance and continuously improve reporting on ESG to address the growing interest of our global stakeholders.”  ]]> <![CDATA[Synapsica partners with GenWorks Health to promote radiology workflow solutions]]> https://biospectrumindia.com/news/95/20095/synapsica-partners-with-genworks-health-to-promote-radiology-workflow-solutions.html https://biospectrumindia.com/news/95/20095/synapsica-partners-with-genworks-health-to-promote-radiology-workflow-solutions.html Wed, 01 Dec 2021 13:25:00 +0530 Synapsica, a Bengaluru-based AI-based radiology reporting company, has partnered with Wipro GE-backed GenWorks Health, a leading healthcare solutions provider.   The partnership will promote and distribute Synapsica’s AI-enabled PACS (Picture Archiving and Communication System) radiology workflow solution ‘Radiolens’ across the country.   The partnership will enable Synapsica to expand its geographic footprint and create access for Radiolens across 300+ tier II and III towns in states like Maharashtra, J&K, Andhra Pradesh, West Bengal, Chhattisgarh, Chennai, Rajasthan and the North East.   The reports generated with the help of Radiolens enable clinicians to better understand the patient's condition and the extent of the disease and be more objective in their recommendation. Radiolens is already being used across 500+ locations in 15 countries including the US, the UK, Australia and Dubai, and handles 1 million+ case annually.      ]]> <![CDATA[Lupin launches learning platform Sciflix for students]]> https://biospectrumindia.com/news/95/20086/lupin-launches-learning-platform-sciflix-for-students.html https://biospectrumindia.com/news/95/20086/lupin-launches-learning-platform-sciflix-for-students.html Wed, 01 Dec 2021 00:00:00 +0530 Mumbai-based pharma firm Lupin has announced the launch of Sciflix, an educational mobile adaptable website for medical students who are pursuing post-graduation with chest specialisation. Curated by Lupin for clinical enhancement, Sciflix is a comprehensive learning platform in pulmonology where all scientific needs of postgraduate students will be addressed by a multisource library under one roof.Rajeev Sibal, President, India Region Formulations, Lupin said, “With Sciflix, we strive to make it easier for students pursuing pulmonology to access the latest research and medical innovations at the touch of their fingertips. Lupin has curated the full range of current evidence-based content to aid doctors in their clinical decision making and as a result, improve patient outcomes.” The mobile compatible website can be accessed by both android and apple devices by medical students across the country for free. ]]> <![CDATA[Akums Drugs & Pharma bags India Pharma Award 2021 ]]> https://biospectrumindia.com/news/95/20073/akums-drugs-pharma-bags-india-pharma-award-2021-.html https://biospectrumindia.com/news/95/20073/akums-drugs-pharma-bags-india-pharma-award-2021-.html Mon, 29 Nov 2021 14:05:00 +0530 New Delhi-based Akums Drugs & Pharmaceuticals has received the ‘India Pharma Award 2021’ during the CphI at the India Expo Center, Noida. The 8th edition of the annual award recognises Akums’ contribution to the healthcare sector. It also acknowledges Akums Drugs & Pharmaceuticals for excellence in contract research and manufacturing.     Akums is one of the largest Contract Research and Manufacturing (CRAMS) organisation responsible for manufacturing approximately 12 per cent of all drugs consumed in the country. The organisation offers a comprehensive range of services starting from formulation development to market launch all en suite. ]]> <![CDATA[Bharat Biotech commences exports of COVAXIN]]> https://biospectrumindia.com/news/95/20078/bharat-biotech-commences-exports-of-covaxin.html https://biospectrumindia.com/news/95/20078/bharat-biotech-commences-exports-of-covaxin.html Mon, 29 Nov 2021 00:00:00 +0530 Hyderabad-based Bharat Biotech has announced that long pending export orders have been executed during November, to be further expanded during the following months. With the number of countries that have granted emergency use approvals for COVAXIN increasing, exports to additional countries will also commence from December, as stated by the company.In addition, beginning November 30, the government of Canada will expand its list of COVID-19 vaccines accepted for entry to Canada to include Sinopharm, Sinovac and COVAXIN. Travellers must have received a full vaccine series at least 14 days before entry to Canada. ]]> <![CDATA[Encube Ethicals to acquire brand Soframycin from Sanofi in India, Sri Lanka]]> https://biospectrumindia.com/news/95/20062/encube-ethicals-to-acquire-brand-soframycin-from-sanofi-in-india-sri-lanka.html https://biospectrumindia.com/news/95/20062/encube-ethicals-to-acquire-brand-soframycin-from-sanofi-in-india-sri-lanka.html Fri, 26 Nov 2021 14:35:00 +0530 Mumbai-based Encube Ethicals has agreed to enter into definitive agreements with Sanofi group and its affiliates, including Sanofi India for acquiring some of its brands - Soframycin, along with other legacy associated brands Sofradex, Sofracort, Soframycin-Tulle for India and Sri Lanka markets.    The transaction is expected to close within the next three months. Encube and Sanofi will jointly make best efforts to ensure a smooth transition, enabling access to the product at all times across the value chain.             ]]> <![CDATA[Novartis India's Netra Suraksha campaign to raise awareness on diabetic eye]]> https://biospectrumindia.com/news/95/20060/novartis-indias-netra-suraksha-campaign-to-raise-awareness-on-diabetic-eye.html https://biospectrumindia.com/news/95/20060/novartis-indias-netra-suraksha-campaign-to-raise-awareness-on-diabetic-eye.html Fri, 26 Nov 2021 09:15:00 +0530 Novartis India will launch ‘Netra Suraksha’ – India Against Diabetes campaign on November 27, 2021. The initiative aims to increase awareness about the risks of eye disorders due to diabetes and educate patients with diabetes to get their eyes checked regularly to minimise the risk of preventable blindness.   The initiative is aimed at creating an awareness programme that will also build effective and efficient partnerships. The initiative will lead to actionable conversations involving leading medical experts, leaders, think tanks and policymakers. The Netra Suraksha campaign will kick off with a series of Round Table discussions on November 27, 2021.   The 45-minute-long launch session having renowned health experts will focus on detection, timely prevention & treatments of diabetes and diabetic eye diseases. ]]> <![CDATA[VAV Life Sciences invests Rs 15 Cr to expand capacity for COVID-19 lipids]]> https://biospectrumindia.com/news/95/20046/vav-life-sciences-invests-rs-15-cr-to-expand-capacity-for-covid-19-lipids.html https://biospectrumindia.com/news/95/20046/vav-life-sciences-invests-rs-15-cr-to-expand-capacity-for-covid-19-lipids.html Wed, 24 Nov 2021 15:15:00 +0530 Mumbai-based VAV Life Sciences, through its subsidiary VAV Lipids, has invested Rs 15 crore to boost production capacity to meet the unprecedented overseas demand for lipidic ingredients.    These lipids are highly specialized biomolecules that are produced in small quantities and are used in the production of Covid-19 vaccines and other medicines for treating a variety of conditions like cancer and heart disease.   The nanotechnology research-based biopharmaceutical company is now undertaking a major expansion project at its EU GMP certified site based in Ratnagiri, Maharashtra.   On completion the expanded facility will produce about six times its current volume, thereby increasing lipid production to meet about 40 per cent of global demand. The new capacity which would be operational from June 2022 will boost VAV’s sales by about 3.5 times to reach Rs 45 crores by 2023.    According to the company, the project is funded by internal accruals and EXIM Bank debt. VAV has been identified by EXIM bank under their ‘Ubharte Sitaare’ programme as a potential company for investment.   ]]> <![CDATA[ACG invests Rs 600 Cr for Asia’s largest capsule manufacturing plant in Maharashtra]]> https://biospectrumindia.com/news/95/20036/acg-invests-rs-600-cr-for-asias-largest-capsule-manufacturing-plant-in-maharashtra.html https://biospectrumindia.com/news/95/20036/acg-invests-rs-600-cr-for-asias-largest-capsule-manufacturing-plant-in-maharashtra.html Tue, 23 Nov 2021 17:30:00 +0530 Mumbai-based ACG has signed an MoU with the Government of Maharashtra to set up Asia’s largest manufacturing plant cum R&D centre at Aurangabad in Maharashtra, to produce 40 billion capsules a year. The plant will serve both, Indian and international pharmaceutical and nutraceutical companies. The proposed plant will employ key design principles from the internationally recognised Leadership in Energy and Environmental Design (LEED) and will be powered significantly by green renewable energy to create and sustain value. Setting new benchmarks for the industry will employ automation and industry 4.0 technologies to minimise resource intensity and ensure products meet and exceed the highest global manufacturing practices (GMP). The Government of Maharashtra has accorded a ‘Mega Project’ status to this project. Karan Singh, Managing Director, ACG, says, “Our vision to be a future-ready solutions provider to the pharma industry anywhere in the world and our proposed investment of approximately $ 100 million (over Rs 600 crores) in this state-of-the-art plant, is an integral part of ACG’s mission to double our capsule manufacturing capacity to 240 billion capsules a year.” Says, Nitin Desai, Senior Vice President, ACG, “We have a long history of operating in Maharashtra and are privileged to sign this MOU with Government of Maharashtra for this mega project which when ready by 2023 will create around 1000 direct and indirect jobs in the region.”  ]]> <![CDATA[Zydus submits NDA to DCGI for chronic kidney disease drug]]> https://biospectrumindia.com/news/95/20032/zydus-submits-nda-to-dcgi-for-chronic-kidney-disease-drug.html https://biospectrumindia.com/news/95/20032/zydus-submits-nda-to-dcgi-for-chronic-kidney-disease-drug.html Tue, 23 Nov 2021 11:15:00 +0530 Ahmedabad-based Zydus Cadila has submitted the New Drug Application (NDA) to the Drug Controller General of India (DCGI) for Desidustat, an oral small molecule hypoxia-inducible factor prolyl hydroxylase (HIF-PH) inhibitor for the treatment of anaemia in patients with Chronic Kidney Disease (CKD) who are on dialysis and not on dialysis.   Desidustat met its primary efficacy endpoint in both Phase 3 trials, DREAM-ND and DREAM-D, conducted in Chronic Kidney Disease (CKD) patients on dialysis and not on dialysis.   The data will be presented at upcoming scientific meetings and published in peer-reviewed scientific journals.   "Desidustat has the potential to provide an oral, safer alternative to currently available injectable erythropoietin- stimulating agents (ESAs), by additionally reducing hepcidin, reducing inflammation, and better iron mobilisation", said said, Pankaj R. Patel, Chairman, Cadila Healthcare. ]]> <![CDATA[US-based Akston Biosciences initiates Ph II trial of second-gen COVID-19 vaccine in India]]> https://biospectrumindia.com/news/95/20029/us-based-akston-biosciences-initiates-ph-ii-trial-of-second-gen-covid-19-vaccine-in-india.html https://biospectrumindia.com/news/95/20029/us-based-akston-biosciences-initiates-ph-ii-trial-of-second-gen-covid-19-vaccine-in-india.html Mon, 22 Nov 2021 16:55:00 +0530 Akston Biosciences Corporation, based in the US, has announced that the first of 100 subjects were dosed in an open-label bridging study of AKS-452, its protein subunit COVID-19 vaccine candidate, in India.   AKS-452 is shelf-stable for at least six months at room temperatures (up to 25° Celsius or 77° Fahrenheit) and maintains its potency for one month at 37° Celsius (99° Fahrenheit).    Drug’s Controller General of India (DCGI), Ministry of Health and Family Welfare, approved the open-label bridging study, being conducted by the Supe Heart & Diabetes Hospital and Research Centre, in Nashik, India along with four other sites in the state of Maharashtra. Veeda Clinical Research Ltd., a CRO with experience overseeing complex clinical trials, is managing the study.    In both studies, healthy volunteers will receive two 90 µg doses 28 days apart. Of the 1,500 participants in Phase II/III study, 1,150 will receive the two-dose regimen, while the remaining 350 will receive two placebo doses. The first dose will include AKS-452 and an adjuvant, which primes the body’s immune response, with the second dose consisting only of AKS-452.    The AKS-452 is a protein sub-unit vaccine, a type of vaccine used safely and widely for decades. AKS-452 does not contain mRNA technology, viral vectors, or a weakened SARS-CoV-2 virus.       ]]> <![CDATA[Boehringer Ingelheim launches heart drug Jardiance in India]]> https://biospectrumindia.com/news/95/20024/boehringer-ingelheim-launches-heart-drug-jardiance-in-india.html https://biospectrumindia.com/news/95/20024/boehringer-ingelheim-launches-heart-drug-jardiance-in-india.html Mon, 22 Nov 2021 14:15:00 +0530 Boehringer Ingelheim has received approval from the Central Drugs Standard Control Organisation (CDSCO) to market its innovator drug Jardiance® (empagliflozin) in India, for additional indication to reduce the risk of cardiovascular death plus hospitalization for heart failure in adults with heart failure and reduced ejection fraction (HFrEF). This new indication approval applies to eligible patients with HFrEF, regardless of their type-2 diabetes status, and is an addition to the previously approved indications for glycemia control in type-2 diabetes, as well as for cardiovascular death in patients with type-2 diabetes and established cardiovascular disease. Jardiance® received approval from the U.S. Food and Drug Administration, earlier this year in August, for the heart failure indication. HFrEF, which accounts for more than half of heart failure cases, occurs when the heart muscle does not contract effectively, and less blood is pumped out to the body compared with a normally functioning heart. Jardiance® is not recommended for people with type 1 diabetes as it may increase the risk of diabetic ketoacidosis in these patients. ]]> <![CDATA[Flipkart forays into health sector with Flipkart Health+]]> https://biospectrumindia.com/news/95/20014/flipkart-forays-into-health-sector-with-flipkart-health.html https://biospectrumindia.com/news/95/20014/flipkart-forays-into-health-sector-with-flipkart-health.html Fri, 19 Nov 2021 14:00:00 +0530 The Flipkart Group announced its foray into the healthcare sector through the launch of Flipkart Health+. The Group has signed definitive agreements to acquire a majority share in Sastasundar Marketplace which owns and operates SastaSundar.com, an online pharmacy and digital healthcare platform, as it focuses on providing consumers access to affordable and convenient healthcare.   Flipkart Health+ will leverage the combined strengths of the Flipkart Group, which includes its pan-India reach and technology capabilities, with SastaSundar’s deep expertise to provide consumers end-to-end offerings in the health-tech ecosystem. It will endeavour to give millions of Indian consumers access to quality and affordable healthcare, starting with e-pharmacy and will add new healthcare services such as e-diagnostics and e-consultation over time. Flipkart Health+ will report to Ajay Veer Yadav, Senior Vice President and Flipkart veteran.   ]]> <![CDATA[Natco Pharma launches drug for gastric & colorectal cancer]]> https://biospectrumindia.com/news/95/20013/natco-pharma-launches-drug-for-gastric-colorectal-cancer.html https://biospectrumindia.com/news/95/20013/natco-pharma-launches-drug-for-gastric-colorectal-cancer.html Fri, 19 Nov 2021 12:55:00 +0530 Hyderabad-based Natco Pharma has launched a novel fixed-dose combination of Trifluridine + Tipiracil for the first time in India under the brand name Tipanat as a pack of 20 tablets in a bottle.   Tipanat is a novel antineoplastic nucleoside analogue indicated for the treatment of advanced colorectal and gastric cancer.   In India, approximately 1,25,000 new cases of the above-mentioned cancers are reported every year.   Tipanat is of high importance in not only extending survival but also in preserving the quality of life in the late lines of treatment which is currently an unmet medical need. NATCO has offered Tipanat at an affordable price. ]]> <![CDATA[CCI aims to identify regulatory and policy levers to improve pharma market outcomes]]> https://biospectrumindia.com/news/95/20008/cci-aims-to-identify-regulatory-and-policy-levers-to-improve-pharma-market-outcomes.html https://biospectrumindia.com/news/95/20008/cci-aims-to-identify-regulatory-and-policy-levers-to-improve-pharma-market-outcomes.html Thu, 18 Nov 2021 00:00:00 +0530 The Competition Commission of India (CCI) has released a report titled ‘Market Study on the Pharmaceutical Sector in India: Key Findings and Observations’. With the overarching objective of understanding the factors that influence price competition in the pharmaceutical sector, the study is focused on the specific realms of pharmaceutical distribution and the role of trade associations therein, trade margins, online pharmacies and the prevalence of branded generic drugs in India and its implications for competition. Since the pharmaceutical sector is a regulated sector, the study also attempted to explore the areas of interface between regulation and competition with a view to ascertain the CCI’s advocacy priorities. The report summarises the main findings and the CCI’s observations based on the study. It is expected that the insights gained from the market study will inform and contribute significantly to the design of the pharma market in India to help attain the objective of affordable medicines for all. ]]> <![CDATA[MSN Labs launches VIGANEXT for epilepsy]]> https://biospectrumindia.com/news/95/19992/msn-labs-launches-viganext-for-epilepsy.html https://biospectrumindia.com/news/95/19992/msn-labs-launches-viganext-for-epilepsy.html Wed, 17 Nov 2021 13:10:00 +0530 MSN Labs has announced the launch of anti-epileptic and India’s first generic vigabatrin powder for the oral solution under the brand name VIGANEXT.    Vigabatrin is recommended as the first-line therapy for infantile spasms, a form of epilepsy that affects 1 in 2,000 children. Previously, the availability of Vigabatrin was wholly dependent on grey market imports which were severely disrupted during the COVID-19 lockdowns. MSN Labs reached out to DCGI for necessary approval to serve epilepsy patients in India with an uninterrupted supply of affordable Vigabatrin.   A therapeutic equivalent, the drug approved by the Drugs Controller General of India (DCGI), is indicated for Infantile Spasms - monotherapy in infants one month to two years of age - and as adjunctive therapy for Refractory Complex Partial Seizures in patients two years of age and older who have responded inadequately to several alternative treatments.   VIGANEXT, available in 500 mg sachet with 30 sachets per pack, is manufactured at our state-of-the-art US FDA and EU approved finished dosages manufacturing campus at Hyderabad. Both BRIVANEXT & VIGANEXT are available in Pharmacies as affordable therapeutic options.    ]]> <![CDATA[Cipla launches pneumotach-based portable, wireless spirometer, Spirofy]]> https://biospectrumindia.com/news/95/19988/cipla-launches-pneumotach-based-portable-wireless-spirometer-spirofy.html https://biospectrumindia.com/news/95/19988/cipla-launches-pneumotach-based-portable-wireless-spirometer-spirofy.html Wed, 17 Nov 2021 09:30:00 +0530 Cipla has announced the launch of Spirofy, India's first pneumotach-based portable, wireless spirometer, on World Chronic obstructive pulmonary disease (COPD) Day. With the launch, the company intends to revolutionise Obstructive Airway Disease (OAD) diagnosis, in line with its ambition to strengthen its position as the lung leader in India. This a part of the company’s #LungAttack campaign that endeavors to drive awareness about COPD and encourage early diagnosis. Cipla's Spirofy is a result of five years of in-house research by the Integrated Product Development (IPD) team, and it aims to transform Obstructive Airway Disease (OAD) diagnosis in India. This advanced device ensures high result accuracy and individual patient safety using Bacterial Viral Filters. Spirofy is entirely wireless with good battery backup, making it suitable for use in outdoor camps, remote areas with power shortages, or simply providing physicians' flexibility and ease of use. The device generates reports in real-time, which can be printed using a portable wireless thermal printer instantly, or a pdf version can be shared on the phone. Cipla will undertake the training of physicians in the interpretation of spirometry results.   Spirometry is the gold standard for COPD diagnosis, however owing to the bulky size, complex functionality, need for regular maintenance are some reasons that impacted the widespread acceptance of conventional spirometers by medical practitioners. This resulted in underdiagnosis or misdiagnosis of COPD cases in India. Currently, COPD remains the second most common cause of death in India after heart diseases, where India alone bears 32 per cent of the global COPD burden. ]]> <![CDATA[Carlyle, Viyash Life Sciences build generic pharma platform in India]]> https://biospectrumindia.com/news/95/19980/carlyle-viyash-life-sciences-build-generic-pharma-platform-in-india.html https://biospectrumindia.com/news/95/19980/carlyle-viyash-life-sciences-build-generic-pharma-platform-in-india.html Tue, 16 Nov 2021 11:40:00 +0530 Global investment firm Carlyle and seasoned pharmaceutical professionals Dr Hari Babu and Dr Srihari Raju Kalidindi, founder and co-founder of Hyderabad-based Viyash Life Sciences have announced that CA Hull Investments, an affiliated entity of CAP V Mauritius and Carlyle (collectively, Carlyle) and Viyash have established an integrated generic pharmaceutical platform in India. Viyash has ten manufacturing facilities in India with a combined capacity of ~2000 KL as well as one formulation facility in the US. The majority of the sites are US FDA approved for API or Intermediates and are capable of servicing both regulated and semi-regulated markets. In the future, Viyash intends to seek further investment opportunities to build scale by targeting acquisitions with niche differentiated capabilities that complement the existing operations of the platform. It will focus on both regulated and emerging markets for generics supply. Dr Hari commented, “Viyash will focus on providing global formulation players with end to end manufacturing capabilities. Our next phase will be to drive further integration and growth opportunities across the three businesses.” “Carlyle’s global healthcare expertise and network of portfolio companies, coupled with our industry knowledge and experience, will help us create significant value for the platform,” added Dr Srihari.   ]]> <![CDATA[Biocon Biologics launches interchangeable biosimilars SEMGLEE and Insulin Glargine injection in US]]> https://biospectrumindia.com/news/95/19987/biocon-biologics-launches-interchangeable-biosimilars-semglee-and-insulin-glargine-injection-in-us.html https://biospectrumindia.com/news/95/19987/biocon-biologics-launches-interchangeable-biosimilars-semglee-and-insulin-glargine-injection-in-us.html Tue, 16 Nov 2021 00:00:00 +0530 Biocon Biologics, a subsidiary of Biocon, and Viatris Inc have announced the US launch of interchangeable biosimilars SEMGLEE® (insulin glargine-yfgn) injection, a branded product, and Insulin Glargine (insulin glargine-yfgn) injection, an unbranded product, to help control high blood sugar in adult and pediatric patients with type 1 diabetes and adults with type 2 diabetes. Both biosimilar products are available in vial and prefilled pen presentations and are interchangeable for the reference brand, LANTUS® (insulin glargine), allowing for substitution at the pharmacy counter. Shreehas Tambe, Deputy CEO, Biocon Biologics said: “At Biocon Biologics we are committed to expanding access to high-quality, affordable biologics to patients worldwide. The launch of our interchangeable biosimilar insulin glargine in the U.S. by our partner Viatris is in line with our aspiration to provide our biosimilar insulins to ‘one in five’ insulin dependent people with diabetes, globally. This is indeed a landmark event and along with the recent formulary listings, we believe it will allow us to improve accessibility, availability and adoption of biosimilars in the U.S. for the benefit of patients and the overall healthcare system.” ]]> <![CDATA[Roche Diabetes Care India adopts two-pronged approach to enhance diabetes awareness]]> https://biospectrumindia.com/news/95/19972/roche-diabetes-care-india-adopts-two-pronged-approach-to-enhance-diabetes-awareness.html https://biospectrumindia.com/news/95/19972/roche-diabetes-care-india-adopts-two-pronged-approach-to-enhance-diabetes-awareness.html Mon, 15 Nov 2021 12:00:00 +0530 Roche Diabetes Care (RDC) India amplified its fight against diabetes this World Diabetes Day through a two-pronged approach of enhancing diabetes awareness and making care more accessible to people with diabetes, in line with this year’s global theme of improving access to care for people with diabetes.   The company has strategically partnered with key stakeholders to co-create an eco-system of care that helps make care more accessible to people with diabetes. Under the ‘Let’s Talk Diabetes’ initiative, the company will aid diabetes screening and awareness camps at over 650 clinics across India by providing 17000 blood glucometers, 300,000 test strips and conducting awareness programmes for people with diabetes and healthcare professionals.    The company has also collaborated with RSSDI to support their ‘Defeat Diabetes’ drive and facilitate up to 100,000 tests by providing blood glucose meters and Accu-Chek Performa strips required for the project. In addition to this, RDC India will collaborate with schools to scale-up ‘Diabeaters’, the award-winning diabetes awareness programme for school children, to conduct a diabetes awareness and education programme for 40000 schools children India. This will also be supported by an employee volunteer drive. In an effort to reach out to the masses, RDC India is also participating in a diabetes public awareness campaign being run by the radio channel Fever FM.     ]]> <![CDATA[Biocon Biologics collaborates with RSSDI for diabetes management]]> https://biospectrumindia.com/news/95/19977/biocon-biologics-collaborates-with-rssdi-for-diabetes-management.html https://biospectrumindia.com/news/95/19977/biocon-biologics-collaborates-with-rssdi-for-diabetes-management.html Mon, 15 Nov 2021 00:00:00 +0530 Biocon Biologics with Research Society for the Study of Diabetes in India (RSSDI) will identify and train ~400 physicians in different districts across the country to address the issue of Type 1 diabetes in children.   Biocon Biologics will enable these healthcare professional (HCPs) with a free supply of its insulins portfolio to help over 1,000 children with Type 1 diabetes, from the marginalised communities, who otherwise cannot afford this therapy.   As a part of this initiative, RSSDI teams will develop the training material, as well as, will train these physicians, to create awareness on effective diabetes management in Type 1 patients, among their peers, and the community at large in their respective districts. Biocon Biologics will provide, educational and other diabetes awareness materials for these training programs as well as will facilitate organising of these events. ]]> <![CDATA[Glenmark Pharma posts PAT of Rs 2,577 M for Q2FY22]]> https://biospectrumindia.com/news/95/19964/glenmark-pharma-posts-pat-of-rs-2577-m-for-q2fy22.html https://biospectrumindia.com/news/95/19964/glenmark-pharma-posts-pat-of-rs-2577-m-for-q2fy22.html Sat, 13 Nov 2021 10:20:00 +0530 Glenmark Pharmaceuticals announced its financial results for the second quarter ended September 30, 2021. For the second quarter of FY 2021-22, Glenmark’s consolidated revenue was at Rs 31,474 million as against Rs 29,525 million recordings an increase of 6.6%.  Consolidated EBITDA was at Rs 5,902 million in the quarter ended September 30, 2021, as against Rs 5,699 million in the previous corresponding quarter, registering an increase of 6.8 per cent.  Profit after Tax (PAT) was at Rs 2,577 million for the quarter ended September 30, 2021, as compared to Rs 2,340 million in the previous corresponding quarter, recording a growth of 10.1 per cent.  “We delivered yet another quarter of consistent performance, both in revenue growth and profitability. We have continued to perform well in our core therapy areas and launched differentiated products,” said Glenn Saldanha, CMD, Glenmark Pharmaceuticals. He further added, “We have substantially reduced our debt through a combination of internal accruals and IPO proceeds. We are focused on enhancing free cash generation and achieving our strategic objectives going forward." ]]> <![CDATA[Sun Pharma to launch Molnupiravir under brand name Molxvir]]> https://biospectrumindia.com/news/95/19957/sun-pharma-to-launch-molnupiravir-under-brand-name-molxvir.html https://biospectrumindia.com/news/95/19957/sun-pharma-to-launch-molnupiravir-under-brand-name-molxvir.html Fri, 12 Nov 2021 14:10:00 +0530 Sun Pharmaceutical Industries is gearing up to introduce Merck Sharpe Dohme (MSD) and Ridgeback’s molnupiravir under the brand name Molxvir in India. The Drugs Controller General of India (DCGI) is currently reviewing clinical data of molnupiravir for the treatment of COVID-19 in adults in India. Molnupiravir is the first oral antiviral approved by the UK Medicines and Healthcare products Regulatory Agency (MHRA) for the treatment of mild-to-moderate COVID-19 in adults. It is under review by the US Food and Drug Administration (FDA) for Emergency Use Authorisation (EUA). In the Phase 3 trial by Merck, Molnupiravir significantly reduced the risk of hospitalisation or death by approximately 50 per cent in a planned interim analysis of the MOVE-OUT trial in at-risk, nonhospitalised adult patients with mild-to-moderate COVID-19. Additionally, based on the participants with available viral sequencing data (approximately 40 per cent of participants), molnupiravir demonstrated consistent efficacy across viral variants like Gamma, Delta, and Mu Molxvir is a registered trademark of Sun Pharma.   ]]> <![CDATA[Bharat Biotech’s COVAXIN 78% effective against COVID-19: Lancet study]]> https://biospectrumindia.com/news/95/19953/bharat-biotechs-covaxin-78-effective-against-covid-19-lancet-study.html https://biospectrumindia.com/news/95/19953/bharat-biotechs-covaxin-78-effective-against-covid-19-lancet-study.html Fri, 12 Nov 2021 09:05:00 +0530 Bharat Biotech has announced that the safety and efficacy analysis data from Phase III clinical trials of COVAXIN is peer-reviewed and published in The Lancet.   The Lancet peer-review confirms the efficacy analysis which demonstrates COVAXIN to be effective against COVID-19. COVAXIN is the only COVID-19 vaccine to have demonstrated efficacy data from phase III clinical trials against the delta variant at 65.2 per cent.     Efficacy analysis demonstrates COVAXIN to be 77.8 per cent effective against symptomatic COVID-19, through evaluation of 130 confirmed cases, with 24 observed in the vaccine group versus 106 in the placebo group. The efficacy analysis demonstrates COVAXIN to be 93.4 per cent effective against severe symptomatic COVID-19.   Safety analysis demonstrates adverse events reported were similar to placebo, with 12 per cent of subjects experiencing commonly known side effects and less than 0.5 per cent of subjects experiencing serious adverse events. The efficacy data demonstrates 63.6 per cent protection against asymptomatic COVID-19. The efficacy data demonstrates 65.2 per cent protection against the SARS-CoV-2, B.1.617.2 Delta. The efficacy data demonstrates 70.8 per cent protection against all variants of SARS-CoV-2 virus.   Dr Krishna Ella, CMD, Bharat Biotech, said, “The peer-review of COVAXIN phase III clinical trial data in The Lancet, an authoritative voice in global medicine validates our commitment to data transparency and meeting the stringent peer-review standards of world-leading medical journals."     ]]> <![CDATA[Aster registers Rs 2,504 Cr consolidated revenue in Q2 FY22]]> https://biospectrumindia.com/news/95/19951/aster-registers-rs-2504-cr-consolidated-revenue-in-q2-fy22.html https://biospectrumindia.com/news/95/19951/aster-registers-rs-2504-cr-consolidated-revenue-in-q2-fy22.html Thu, 11 Nov 2021 18:45:00 +0530 Aster DM Healthcare announced its financial results for the quarter ended September 30, 2021. The operational revenue increased by 12 per cent Y-o-Y to Rs 2,504 crore compared to Rs 2,243 crore. EBITDA (including other income) increased by 26 per cent Y-o-Y to Rs 352 crore compared to Rs 279 crore. PAT (Pre- Non-Controlling Interest) increased by 202 per cent to Rs 128 crore compared to Rs. 42 crore in FY 21 Q2. PAT (Post Non-Controlling Interest) increased by 225 per cent to Rs 107 crore compared to Rs 33 crore in the same period, previous financial year.   ]]> <![CDATA[Oasis Fertility opens centre in Guntur, AP]]> https://biospectrumindia.com/news/95/19948/oasis-fertility-opens-centre-in-guntur-ap.html https://biospectrumindia.com/news/95/19948/oasis-fertility-opens-centre-in-guntur-ap.html Thu, 11 Nov 2021 15:20:00 +0530 Oasis Fertility has opened a new state-of-the-art full-fledged IVF centre in Guntur. This is the third clinic in the region after Vijayawada and Vishakhapatnam. The company plans to open centres in Ongole, Eluru, Kurnool and Tirupathi by December 2021.The centre was inaugurated by Dr Durga G Rao – Co-Founder and Medical Director, Oasis Fertility and Dr Krishna Chaitanya – Scientific Head and Clinical Embryologist, Oasis Fertility along with Dr Sujatha Vellanki and Dr Ramya Vicharapu - Clinical Heads at Vijaywada and Guntur respectively.  According to a recent study by the National Family Health Survey, while the current fertility rate in India (2021) is 2.179 births per woman, Andhra Pradesh has a Total Fertility Rate (TFR) of 1.7. Also, the city of Guntur currently has a dubious distinction of having a low TFR of 1.5. Experts state that women’s health deterioration coupled with male fertility has been attributed to this major cause in Guntur. To add to this lifestyle factors like stress, obesity, and late marriages have been rising in Guntur city. Moreover, pesticide exposure in men seems to be engendering male fertility issues in men.  Oasis Fertility has received growth capital in 2016 from India Life Sciences Fund II, a leading healthcare and life sciences-focussed fund, and was the first institutional investment in an IVF chain in India. ]]> <![CDATA[Lincoln Pharma posts net profit of Rs 22.88 Cr in Q2 FY22 ]]> https://biospectrumindia.com/news/95/19947/lincoln-pharma-posts-net-profit-of-rs-22-88-cr-in-q2-fy22-.html https://biospectrumindia.com/news/95/19947/lincoln-pharma-posts-net-profit-of-rs-22-88-cr-in-q2-fy22-.html Thu, 11 Nov 2021 15:15:00 +0530 Lincoln Pharmaceuticals has reported a net profit of Rs 22.88 crore for the Q2 FY22 ended September 2021 as against a net profit of Rs 20.20 crore in the corresponding period last year, a growth of 13.27 per cent. The net revenue for the quarter was reported at Rs 129.41 crore, higher by 4.78 per cent over the previous fiscal’s same period net revenue of Rs 123.51 crore. EBITDA for the quarter was reported at Rs 31.95 crore as compared to Rs 29.02 crore in the corresponding period last year. EPS was reported at Rs 11.44 per share for Q2FY22 as compared to Rs 10.10 per share in the corresponding period last year. Mahendra Patel, MD, Lincoln Pharmaceuticals said, “The company has delivered a robust operational and financial performance during the quarter and is confident to improve our growth numbers going forward. Recently the company has also received approval from Australia's medicines and medical devices regulator - Therapeutic Goods Administration (TGA) for its Khatraj facility. TGA and EU GMP approvals will further strengthen the company's presence in the export market. Strategic growth initiatives, product and geographical expansion, operational efficiency are likely to maximise value for all stakeholders in the near to medium term." ]]> <![CDATA[Navi Mumbai-based RRR Labs to participate in Bengaluru Tech Summit]]> https://biospectrumindia.com/news/95/19945/navi-mumbai-based-rrr-labs-to-participate-in-bengaluru-tech-summit.html https://biospectrumindia.com/news/95/19945/navi-mumbai-based-rrr-labs-to-participate-in-bengaluru-tech-summit.html Thu, 11 Nov 2021 11:45:00 +0530 Navi Mumbai-based RRR Labs will participate in Bengaluru Tech Summit 2021. RRR Labs has served the Indian vaccine and biosimilar manufacturing industry by introducing newly developed products and services from closely associated and renowned overseas partners, backing it up with local support in all forms. The products include media, feeds and supplements for mammalian cell culture. Sample quantities are stored at our facility to respond quickly to R&D sample needs. Dr Nagaraj Rao, MD, Rane Rao Reshamia Laboratories said, "We facilitate joint R&D projects between Indian and overseas companies and institutes in the broad field of biotechnology and life sciences, such as in the areas media optimisation, cell line evaluation, spent media analytics and API synthesis. We identify technology partners, especially in Germany/EU, for interested Indian companies in the field of life sciences. We are trusted representatives of overseas manufacturers of bulk drugs and excipients in India. We also manufacture organic fine chemicals by classical synthesis and biotransformation routes." ]]> <![CDATA[Metropolis Healthcare posts PAT of Rs 58.4 Cr at Q2FY22]]> https://biospectrumindia.com/news/95/19944/metropolis-healthcare-posts-pat-of-rs-58-4-cr-at-q2fy22.html https://biospectrumindia.com/news/95/19944/metropolis-healthcare-posts-pat-of-rs-58-4-cr-at-q2fy22.html Thu, 11 Nov 2021 10:10:00 +0530 Metropolis Healthcare has announced its unaudited consolidated financial results for the second quarter (Q2FY22). The non-covid revenue has grown 38 per cent YoY to Rs 260 crore. In Q2FY22, the company's revenue from operations was at Rs 302.6 crore, EBITDA before CSR & ESOP was at Rs 93.2 crore and Profit After Tax at Rs 58.4 crore."With the economy now strongly recovering from the pandemic, we expect our non-covid business to continue growing sustainably. We recently acquired Hitech Diagnostics which will further enable us to scale up our business, improve the B2C revenue contribution and increase our market penetration by catering to the value segment of the market," said Ameera Shah, Promoter and MD, Metropolis Healthcare. ]]> <![CDATA[Alniche Life Sciences unveils digital initiatives]]> https://biospectrumindia.com/news/95/19939/alniche-life-sciences-unveils-digital-initiatives.html https://biospectrumindia.com/news/95/19939/alniche-life-sciences-unveils-digital-initiatives.html Wed, 10 Nov 2021 17:15:00 +0530 Alniche Life Sciences has stepped up with multi-pronged and targeted digital initiatives for doctors, patients, healthcare workers to maintain the momentum. Alniche Health app offers a wide area of information like kidney health, a range of recipes, exercises, and daily health routines for CKD patients. The company collaborated with DRiefcase to provide tele-consultation to ease the interaction between patients and doctors. It has also launched a health channel 'My Healthytude' an online health info programme that celebrates the word of a healthy lifestyle. This initiative focuses on educating patients on their health conditions and guides them to visit physicians for seeking advice. Alniche started an initiative, DRSC (Doctor’s Scientific Resource for Continuous Education), that focuses on providing educational information for doctors, practising physicians, nutritionists, paramedics, and medical enthusiasts.“We coordinated with various IT service providers,” Karan Arora, Director Marketing & International Business, Alniche Life Sciences. ]]> <![CDATA[Takeda receives Arogaya CIBioD Innovation and Enterprise Leadership Award]]> https://biospectrumindia.com/news/95/19937/takeda-receives-arogaya-cibiod-innovation-and-enterprise-leadership-award.html https://biospectrumindia.com/news/95/19937/takeda-receives-arogaya-cibiod-innovation-and-enterprise-leadership-award.html Wed, 10 Nov 2021 12:10:00 +0530 Takeda India has been awarded the Arogaya CIBioD Innovation and Enterprise Leadership Award at the Tech4Seva Summit. The award was received for the company's holistic initiatives designed to improve the quality of life and standards of care for patients, including the 'Blueprint for rare diseases' initiative   The awarding body, The Center for Innovation and BioDesign (CIBioD), is an initiative of the Indian Council of Medical Research (ICMR) aimed at promoting research, innovation, and entrepreneurship in the Indian Healthcare System.    Takeda's 'Blueprint for rare diseases' initiative was pioneered together with all the relevant stakeholders in the healthcare value chain, including the Ministry of Health – central and state, patient groups, notified Centre of Excellence, NGOs, and industry bodies. As a part of this initiative, a charter would be developed for stakeholders to commit to improving care and management of Lysosomal Storage Diseases (LSDs) in evolving healthcare systems. It bolsters the nation's commitment towards better health outcomes for collective solution-based innovative approaches and shared responsibilities.    The company has also developed innovative technology-based solutions to improve easy access and coverage to healthcare by connecting healthcare providers and patients.     ]]> <![CDATA[GE to execute tax-free spin-offs of healthcare in early 2023]]> https://biospectrumindia.com/news/95/19936/ge-to-execute-tax-free-spin-offs-of-healthcare-in-early-2023.html https://biospectrumindia.com/news/95/19936/ge-to-execute-tax-free-spin-offs-of-healthcare-in-early-2023.html Wed, 10 Nov 2021 11:50:00 +0530 GE has announced plans to form three industry-leading, investment-grade global public companies focused on growth sectors of Aviation, Healthcare, and Energy. The company wants to pursue a tax-free spin-off of GE Healthcare, creating a pure-play company at the centre of precision health in early 2023, in which GE expects to retain a stake of 19.9 per cent. H Lawrence Culp, Jr, Chairman and CEO, GE said, “At GE we have always taken immense pride in our purpose of building a world that works. The world demands—and deserves—we bring our best to solve the biggest challenges in flight, healthcare, and energy. By creating three industry-leading, global public companies, each can benefit from greater focus, tailored capital allocation, and strategic flexibility to drive long-term growth and value for customers, investors, and employees. We are putting our technology expertise, leadership, and global reach to work to better serve our customers.”   ]]> <![CDATA[Manipal Hospitals, Columbia Asia undergo brand integration]]> https://biospectrumindia.com/news/95/19934/manipal-hospitals-columbia-asia-undergo-brand-integration.html https://biospectrumindia.com/news/95/19934/manipal-hospitals-columbia-asia-undergo-brand-integration.html Wed, 10 Nov 2021 08:55:00 +0530 Manipal Hospitals Group, Columbia Asia Hospitals has now been rebranded to Manipal Hospitals. The rebranding emphasises Manipal's modern appearance while also highlighting the high quality, professional services that patients can expect.With the rebranding and new logo launch, all 27 units of Manipal Hospitals including Columbia Hospitals and Vikram Hospital will be brought under one umbrella. The Columbia Asia Hospitals and Vikram Hospital across the country will be rebranded as ‘Manipal Hospital’. This rebranding will be a change in the identity but the focus on providing quality healthcare will remain the same. The hospital's rebranding and new lower-case logo reflect not only the hospital's consistent image of clinical skill, reliability, and professionalism, but also how it cares for people: patients, physicians, staff, and the public. While looking to the future, the new branding and logo will demonstrate a strong dedication to enhancing clinical knowledge. ]]> <![CDATA[O2 Cure unveils portable air purifier]]> https://biospectrumindia.com/news/95/19926/o2-cure-unveils-portable-air-purifier.html https://biospectrumindia.com/news/95/19926/o2-cure-unveils-portable-air-purifier.html Tue, 09 Nov 2021 09:50:00 +0530 Gurugram-based O2 Cure by ZECO Aircon has introduced a portable air purifier REME LED. The portable air purifier protects from air-borne harmful pathogens including the novel SARS COV2 coronavirus.   It offers REME LED active purification technology by RGF, USA along with washable filters and ultra-quiet operation. Ideal for small spaces, the product features a long power life and functions as a low maintenance advanced catalyst. The innovation is priced at Rs 21,995.   Kartik Singhal, Founder, O2 Cure and Director, Zeco Aircon said, “The O2 Cure REME Led portable purifier has a one-of-a-kind design that intelligently purifies larger indoor areas up to 200 square feet." ]]> <![CDATA[LupinLife’s Be One wins accolades for packaging]]> https://biospectrumindia.com/news/95/19920/lupinlifes-be-one-wins-accolades-for-packaging.html https://biospectrumindia.com/news/95/19920/lupinlifes-be-one-wins-accolades-for-packaging.html Mon, 08 Nov 2021 15:15:00 +0530 LupinLife, the consumer healthcare business of global pharma major Lupin Limited (Lupin), won the Best Packaging Design – Graphics and Brand Value Add Award at the India Packaging Awards for its daily health supplement - Be One. This award is an initiative by Informa Markets in India to honour the best branding initiatives from the pharma packaging space.    Speaking on this association  Anil Kaushal,  Head of  LupinLife Business,  said,  “We have received a phenomenal response to the launch of Be One and its design is as enthusing as its components. We are very humbled to receive this honour.” ]]> <![CDATA[Bugworks Research initiates Ph 1 trial of critical bacterial infection drug]]> https://biospectrumindia.com/news/95/19922/bugworks-research-initiates-ph-1-trial-of-critical-bacterial-infection-drug.html https://biospectrumindia.com/news/95/19922/bugworks-research-initiates-ph-1-trial-of-critical-bacterial-infection-drug.html Mon, 08 Nov 2021 00:00:00 +0530 Bengaluru-based Bugworks Research has announced that the first human dose was administered in Phase 1 clinical trial evaluating BWC0977: a next-generation broad-spectrum, novel bacterial topoisomerase inhibitor (NBTI), supported by Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X).   BWC0977 is a highly potent, intravenous broad-spectrum antibiotic with the potential for oral administration, for the treatment of serious multidrug-resistant (MDR) Gram-negative infections. BWC0977 can address many serious hospital and community infections and combat a broad spectrum of biothreat pathogens.   BWC0977, which emerged within less than a hundred compounds synthesised, is active against clinical isolates that are resistant to antibiotics currently in clinical use including fluoroquinolones, carbapenems, cephalosporins, colistin etc., and is efficacious in murine thigh, lung, and urinary tract infection models with adequate safety margins in pre-clinical species.   The Phase 1 clinical trial is being conducted in Adelaide, Australia, after a positive pre-IND meeting with the US FDA and with approval from Human Research Ethics (HREC) in Australia. This trial is a randomised, double-blind, placebo-controlled study of the safety, tolerability, and pharmacokinetics of single and multiple ascending doses of BWC0977 in healthy adult subjects. Results are expected by early 2022.   ]]> <![CDATA[Lupin launches authorised generic version of Antara in US]]> https://biospectrumindia.com/news/95/19909/lupin-launches-authorised-generic-version-of-antara-in-us.html https://biospectrumindia.com/news/95/19909/lupin-launches-authorised-generic-version-of-antara-in-us.html Wed, 03 Nov 2021 17:55:00 +0530 Lupin announced the launch of the authorised generic version of Antara (Fenofibrate) Capsules, 30 mg and 90 mg, of Lupin Atlantis Holdings, SA Corporation, a wholly-owned subsidiary of Lupin.Fenofibrate capsules are indicated as adjunctive therapy to diet to reduce elevated low-density lipoprotein cholesterol (LDL-C), total cholesterol (total-c), Triglycerides (TG) and apolipoprotein B (Apo B), and to increase high-density lipoprotein cholesterol (HDL-C) in adult patients with primary hypercholesterolemia.Fenofibrate Capsules (RLD: Antara4 Capsules) had estimated annual sales of $7 million in the US (IQVIA MAT September 2021).   ]]> <![CDATA[Venus Remedies H1 net profit registers 315% growth]]> https://biospectrumindia.com/news/95/19902/venus-remedies-h1-net-profit-registers-315-growth.html https://biospectrumindia.com/news/95/19902/venus-remedies-h1-net-profit-registers-315-growth.html Tue, 02 Nov 2021 17:45:00 +0530 Venus Remedies has posted a 315 per cent increase in net profit in the first half of this financial year as compared to the corresponding period last year. Announcing its unaudited half-yearly financial results for FY 2021-22 for the period April 1 to September 30, Venus Remedies stated that its net profit rose to Rs 38.72 crore from Rs 9.33 crore in the corresponding half of the previous year after having divested itself of all interest liabilities following repayment of its entire debt with banks and financial institutions in the financial year 2020-21. The company’s EBIDTA percentage to revenue from operations also grew from 13.15 per cent to 15.84 per cent, reflecting steady growth. Likewise, the total sales of Venus Remedies rose to Rs 329.49 crore as against Rs 298.12 crores in the corresponding period of the financial year 2020-21. “The credit for our profitability growth in the first half of this financial year largely goes to our astute financial management. Having cleared our entire debt, we have reduced our interest cost and financial obligations to zero. Another major contributory factor has been our robust sales, which have in turn considerably reduced our freight costs and other selling expenses. The proactive approach we have followed in monetising our intellectual property and further strengthening our relations with our suppliers and customers has also worked to our advantage,” said Saransh Chaudhary, President, Global Critical Care, Venus Remedies. ]]> <![CDATA[Sun Pharma posts net profit of Rs 20,470 M in Q2FY22]]> https://biospectrumindia.com/news/95/19901/sun-pharma-posts-net-profit-of-rs-20470-m-in-q2fy22.html https://biospectrumindia.com/news/95/19901/sun-pharma-posts-net-profit-of-rs-20470-m-in-q2fy22.html Tue, 02 Nov 2021 16:30:00 +0530 Sun Pharmaceutical Industries has reported financials for the second quarter ending September 30, 2021. In Q2FY22 consolidated financials, the sales from operations at Rs 95,567 million, a growth of 13 per cent over Q2 last year. India sales was at Rs 31,878 million, up 26 per cent over the same quarter last year. The US finished dosage sales was at $361 million, showing a growth of 8 per cent over Q2 last year, the emerging markets sales was at $243 million, up by 16 per cent over Q2 last year, the Rest of World sales at $188 million, up by 5 per cent over the same quarter last year. R&D investments have been reported at Rs 5,364 million compared to Rs 6,127 million for Q2FY21, EBITDA at Rs 25,608 million, up by 21 per cent over Q2 last year, with a resulting EBITDA margin of 26.8 per cent. The net profit for the quarter was at Rs 20,470 million, up 29 per cent compared to an adjusted net profit of Q2 last year and up 13 per cent versus reported net profit YoY.  In H1FY22, the consolidated sales from operations was at Rs 192,262 million, a growth of 20 per cent over the same period last year, India sales was at Rs 64,961 million, up by 32 per cent over H1 last year, US finished dosage sales at $741 million up by 20 per cent over H1 last year. Emerging markets sales has been reported at $461 million up by 20 per cent over H1 last year. The Rest of World sales was at $373 million, up by 18 per cent over H1 last year. EBITDA at Rs 53,325 million up 38 per cent over H1 last year, with a resulting EBITDA margin of 27.7 per cent. Excluding the exceptional items, the adjusted net profit for H1FY22 was at Rs 40,263 million, up 47 per cent YoY. The company reported net profit for H1FY22 was at Rs 34,912 million compared to Rs 1,572 million for H1 last year. Dilip Shanghvi, MD, Sun Pharmaceutical Industries said, “Following our good Q1 performance, we have sustained the positive momentum in Q2 with a topline growth of 13 per cent YoY, driven by broad-based growth across multiple geographies. Our global speciality business has grown by 43 per cent over Q2 last year. Ilumya has grown both YoY and sequentially. Our India business continues to do well with a growth of 26 per cent YoY. We remain steadfast in our focus on growing our overall business and simultaneously strengthening our global speciality portfolio. The recent launch of Winlevi in the US and Ilumya in Canada is a step forward in this direction.” ]]> <![CDATA[Cloudnine opens second fertility centre in Panchkula]]> https://biospectrumindia.com/news/95/19897/cloudnine-opens-second-fertility-centre-in-panchkula.html https://biospectrumindia.com/news/95/19897/cloudnine-opens-second-fertility-centre-in-panchkula.html Tue, 02 Nov 2021 13:05:00 +0530 Cloudnine has launched its second dedicated state-of-the-art fertility services at Panchkula, a part of the tri-city area. The centre located at Panchkula brings the total number of Cloudnine fertility centres in India to 17. Services at the unit will consist of advanced medical infrastructure and shall offer treatment for procedures such as intrauterine insemination (IUI), laparoscopy, hysteroscopy along with counselling on all comprehensive male and female fertility solutions. The team of specialists include experienced doctors in fertility, reproductive medicine, reproductive endocrinology, embryology, andrology among others. Dr Pawan Kumar, Regional Director (North), Cloudnine “With the addition of our services in Panchkula we will be strengthening our commitment with advanced fertility services and individualised patient care to every couple currently facing problems related to conception and childbirth.” ]]> <![CDATA[India sees sizable improvement in finished dosage reputation: CPhI Annual Report survey]]> https://biospectrumindia.com/news/95/19892/india-sees-sizable-improvement-in-finished-dosage-reputation-cphi-annual-report-survey.html https://biospectrumindia.com/news/95/19892/india-sees-sizable-improvement-in-finished-dosage-reputation-cphi-annual-report-survey.html Mon, 01 Nov 2021 17:20:00 +0530 CPhI & P-MEC India, organised by Informa Markets, is set to welcome attendees and exhibitors from around the world, both online and in-person, as new CPhI analysis points to sustained pharma growth in India, with an improving outlook for finished dosage, API and biologics.    The India-specific findings of the CPhI Annual Report survey, conducted among 350 executives, point to a significant jump in the country’s global reputation with India widely perceived to be benefiting from post-pandemic macro-economic and supply chain changes.   With these positive results and growth forecast as the event’s backdrop, the 14th Annual CPhI & P-MEC India will run in a hybrid form, with an online conference and networking from November 15-30 alongside an in-person event in New Delhi on November 24-26.   The online event platform will open more than a week before the start of the in-person event, empowering the industry to maximise the value they get from the in-person CPhI & P-MEC India. This enables companies to identify more partners in advance and pre-qualify their leads. The online platform will also play host to some 30 sessions spanning four tracks – Drug Development and Delivery, API and Next Gen Labs, biosimilars and mAbs and digitization. Running alongside the event is India Pharma week which will host the ‘Women in Pharma’ roundtable as well as the eighth annual India Pharma Awards.   “There is a tremendous need for new manufacturing partners and as shown in the report – Indian manufacturers, in particular, are in high demand. By delivering a hybrid event and offering a platform where international and national buyers and suppliers can profile themselves, we are facilitating a greater opportunity for future partnerships,” commented Silvia Forroova, Brand Director, Informa. ]]> <![CDATA[Neuberg Diagnostics opens lab in Kaloor, Kerala]]> https://biospectrumindia.com/news/95/19891/neuberg-diagnostics-opens-lab-in-kaloor-kerala.html https://biospectrumindia.com/news/95/19891/neuberg-diagnostics-opens-lab-in-kaloor-kerala.html Mon, 01 Nov 2021 16:50:00 +0530 Chennai-based Neuberg Diagnostics has opened a state-of-the-art pathology lab in Kaloor (Kochi), Kerala.   As a part of its FY22 expansion plan, Neuberg will be launching 30 new labs and more than 500 collection centres in domestic and international markets.   It will also be establishing technology incubation centres in the US and Europe to access the latest technologies and make developing countries ready for precision diagnostics in the evolving personalised medicine arena.   Dr GSK Velu, CMD, Neuberg Diagnostics, said, “We are expanding internationally by increasing our presence in the US and opening diagnostic facilities in East Africa and West Asia. Additionally, we will be commissioning a state-of-the-art testing facility in Dubai which will act as a hub in West Asia. This is in addition to our plans for Sri Lanka, Nepal, Bangladesh, and Germany which are likely to fructify in the current financial year.”    Aishwarya Vasudevan, Group Chief Operating Officer, Neuberg Diagnostics, said, “The establishment of the new lab in Kaloor is yet another step by Neuberg towards alleviating pain points in the healthcare ecosystem and ensuring that advanced diagnostics tests are available to people in India and overseas.”      ]]> <![CDATA[MaxiVision, Aswini Netralayam JV to create premier eye care chain in districts of AP]]> https://biospectrumindia.com/news/95/19887/maxivision-aswini-netralayam-jv-to-create-premier-eye-care-chain-in-districts-of-ap.html https://biospectrumindia.com/news/95/19887/maxivision-aswini-netralayam-jv-to-create-premier-eye-care-chain-in-districts-of-ap.html Mon, 01 Nov 2021 11:50:00 +0530 Hyderabad-based MaxiVision Super Specialty eye hospitals and Narasaraopet (Guntur District)-based Aswini Netralayam, of Dr AAV Ramalinga Reddy, have entered into a Joint Venture to create a super speciality eye care chain in various towns, in coastal Andhra Pradesh, with state-of-the-art technology in eye care affordable to all economic segments.    The new JV merged with Maxivision Super Specialty Eye Hospitals, will be known as Maxivision Dr Ramalinga Reddy Eye Hospitals, and will commence operations from December 2021.   The hospital of DrRamalinga Reddy will now expand with joint venture brand, to Macherla and Guntur from December 2021, and other potential towns of Prakasam districts post-April 2022. ]]> <![CDATA[Optimus concludes Molnupiravir Phase 3 Clinical Trial study]]> https://biospectrumindia.com/news/95/19884/optimus-concludes-molnupiravir-phase-3-clinical-trial-study.html https://biospectrumindia.com/news/95/19884/optimus-concludes-molnupiravir-phase-3-clinical-trial-study.html Sat, 30 Oct 2021 10:55:00 +0530 Optimus Group has announced the successful completion of the much-awaited Molnupiravir Oral Capsule Phase 3 Clinical Trial. The pharmaceutical company was the first to file for Phase 3 Clinical Trial of Molnupiravir with the Central Licensing Authority. The Clinical Trial partner of Optimus, JSS Research was tasked with the execution of the trial at the grass-root level.    With 29 study sites across India roughly covering 96 per cent of the nation’s demographic capital, the trial not only aims to prove the superiority of Molnupiravir over the standard treatment options but also prove the drug’s efficacy across India’s gene pool diversity.    Speaking on the development, Dr D Srinivas Reddy, CMD, Optimus Pharma said, “With an indigenously developed formulation, Optimus strives to establish its belief in the Make in India initiative of the Government of India. We aim to develop a cutting-edge and affordable treatment option for COVID-19 and neutralise the disease in minimum treatment duration. We are fully committed to supporting our business partners across various regions of the world who are counting on us for the supply of Molnupiravir.”    ]]> <![CDATA[Say Goodbye To Hair Fall]]> https://biospectrumindia.com/news/95/9409/say-goodbye-to-hair-fall.html https://biospectrumindia.com/news/95/9409/say-goodbye-to-hair-fall.html Sat, 30 Oct 2021 00:00:00 +0530 Well, it is time to take a breather and bid bye to clogged drains and messed-up combs. Here is how to save your hair from breakage. Follow some simple hair care tips, and with products like Vichy Shampoo, which are completely safe to use, you will soon flaunt thick and lustrous hair.   Avoid Pulling Your Hair If your hairstyle pulls the hair, then avoid such styles. Your hair has a flexible texture but cannot be stretched indefinitely. If you end up stretching it a lot, then it could get damaged permanently. If the hair is pulled from the scalp too much, it loosens the bond with the scalp causing hair fall.   Styling Tools Damage The Hair Heat causes the hair follicles to get dehydrated and makes them vulnerable to severe damage. Hair straighteners and hair dryers used for long can cause the hair to get thin and damaged.   Use A Mild Shampoo Picking up any shampoo from a departmental store and applying it on your hair is a sure shot reason for hair fall and breakage. Shampoo should be used to clean your hair and to remove excess oil and dirt. However, the commercial shampoos available today are made of harsh chemicals that strip the hair of fatty acids and natural oils. It, in turn, makes the hair supple. So take time and read the ingredients used in your shampoo. It is good to invest in the best quality shampoos for the better health of your hair.   Using Chemicals And Bleach On Your Hair Could Damage It Styling products use chemicals. And have you wondered what it does to your hair? Regular application of dyes, using iron, and treating your hair with harmful chemicals causes the hair follicles to get damaged. If you have been using them, it is time to limit usage.   Try Low-Level Light Therapy People with excess hair fall conditions have benefited from low-level light therapy. The procedure promotes the growth of hair cells and repairs them. However, this therapy has to be prescribed by the doctor.   Comb Your Hair With A Soft Brush Most people usually overlook the hairbrush or comb that they use several times in the day to set their hair. This is, however, a vital thing to consider. Always use a soft brush on your hair to not cause hair damage. Something that is made of natural fibers does wonders. Natural hair brushes also promote a healthy sebum oil level in your hair. The hair contains keratin protein, so it is important to brush your hair gently and through its ends to smoothen the condition of your hair cuticle.   Have A Protein-Rich Diet It has been noticed that several patients who complain of hair loss have low amino acid and protein intake. Nutritional deficiencies could be related to hair fall. It is thus important to eat a healthy diet, stay hydrated and live healthy to prevent hair fall.   You May Start A Multivitamin Supplement Vitamins and minerals help to prevent loss of hair. Some vitamins levels that you may want to get checked to supplement if required are:   Vitamin B Selenium Zinc Iron Vitamin D Vitamin C Vitamin E Vitamin A   There are supplements available that contain the essential vitamins in a single multivitamin tablet. It is always recommended that you consult a doctor before taking one.   Scalp Massage Helps The traditional method of massaging the scalp also promotes hair growth. A 4-minute scalp massage each day stimulates the hair follicles and prevents hair fall. The research is in the nascent stage, though and needs to be tried on a larger sample, but again, considering no side effects, there is no harm in trying this age-old technique to promote healthy hair growth. Just use quality hair oil and massage your hair and then wash it off with a gentle and anti-hair fall shampoo.   Care Well For Your Scalp And Hair Taking good care of your scalp and hair prevents hair loss and improves hair growth. Washing your hair with a mild shampoo keeps the hair and the scalp clean, which in turn prevents hair loss and damage.   Healthy Hair Products Are A Must Hair loss is a concern that can be caused by genetics or aging. It is important to understand the underlying cause of hair loss and then select the best treatment. Hair loss, however, is not uncommon. If the hair fall is manageable, using good quality shampoo and hair care products can improve the condition. In case of excess hair fall, it is always best to consult a dermatologist to get a proper diagnosis and treatment.   While hair loss is not life-threatening, it does affect the confidence and the personality of an individual. Investing in good quality hair care products like Vichy Shampoo can make a great difference to the quality of your hair and reduce hair breakage.         ]]> <![CDATA[Metropolis Healthcare partners with Immuno Path lab]]> https://biospectrumindia.com/news/95/19866/metropolis-healthcare-partners-with-immuno-path-lab.html https://biospectrumindia.com/news/95/19866/metropolis-healthcare-partners-with-immuno-path-lab.html Thu, 28 Oct 2021 12:30:00 +0530 Metropolis Healthcare launched a new centre in Coimbatore, Tamil Nadu named Immuno Lister Metropolis Lab. This 3,000 sq ft laboratory can conduct 1000 sample testing per month with a quick turnaround time and high-quality reports. The inauguration was done by Dr Asha Rao, Managing Director - Rao Hospital, Chairperson - Endometriosis committee, FOGSI 2020-2022.   Immuno Lister Metropolis lab, Coimbatore will offer about 300 clinical laboratory tests and profiles, which are used for prediction, early detection, diagnostic screening, confirmation and/or monitoring of the disease.   With decades of experience under the belt, Metropolis has conscientiously developed the Indian Reference Range for an extensive test menu, which is now being used by thousands of laboratories across the country.   The new lab is located at West TV Swamy Road, RS Puram, Coimbatore. ]]> <![CDATA[Cloudphysician raises $4 M in Pre Series A Funding from Elevar Equity]]> https://biospectrumindia.com/news/95/19865/cloudphysician-raises-4-m-in-pre-series-a-funding-from-elevar-equity.html https://biospectrumindia.com/news/95/19865/cloudphysician-raises-4-m-in-pre-series-a-funding-from-elevar-equity.html Thu, 28 Oct 2021 11:55:00 +0530 Cloudphysician, a healthcare and technology solutions provider focussed on affordable and quality critical care, has raised $4 million Pre Series A funding from Elevar Equity. Founded by Dr Dhruv Joshi (Pulmonary and Critical Care Specialist; American Board of Internal Medicine) and Dr Dileep Raman (Pulmonary, Critical Care Medicine and Sleep Medicine Specialist; American Board of Internal Medicine), Cloudphysician is on a mission to tackle the problem of unavailability of skilled critical care specialists in remote locations in India and emerging markets. With this round of funding, Cloudphysician will expand its global footprint and invest in commercial, medical, technology and data science talent.   Collaborating with Cloudphysician gives hospitals access to their robust team of highly experienced intensive care experts and their proprietary ICU management cloud platform, RADARTM to manage critically ill patients remotely and in real-time. This exponentially improves the level of care and quality that hospitals can provide for patients.       ]]> <![CDATA[Cipla posts PAT of Rs 711 Cr in Q2FY22]]> https://biospectrumindia.com/news/95/19849/cipla-posts-pat-of-rs-711-cr-in-q2fy22.html https://biospectrumindia.com/news/95/19849/cipla-posts-pat-of-rs-711-cr-in-q2fy22.html Wed, 27 Oct 2021 09:05:00 +0530 Cipla announced its unaudited consolidated financial results for the quarter ended September 30, 2021. In India, the overall business grew by 16 per cent YoY on a high FY21 base led by sustained volume traction across core therapies; covid portfolio contribution normalising in-line with expectations. Income from operations has been registered at Rs 5,520 crore, up by 10 per cent YoY. EBITDA has been posted at Rs 1,226 crore up by 4 per cent YoY and profit after tax at Rs 711 crore registering 7 per cent YoY. Umang Vohra, MD and Global CEO, Cipla, said, "I am pleased to see the strong momentum in core therapies across our branded markets and sustained cost control leading to 10 per cent revenue growth and  22.2 per cent EBITDA margin for the quarter, offsetting price erosion and normalising covid contribution. In India, we continue to drive strong performance led by sustained volume traction despite a high FY21 base.  Our collaboration with Eli Lily for their diabetes products helps us further strengthen our endeavour of creating access to innovative medicines in line with the One-India strategy. The US business also witnessed a healthy run rate driven by core portfolio and desired traction in respiratory franchise across Albuterol and Arformoterol. International markets rebounded in line with expectations despite continuing  geopolitical challenges. ]]> <![CDATA[Eris Lifesciences launches 'Metabolic Roadinar' to support Continuing Medical Education ]]> https://biospectrumindia.com/news/95/19842/eris-lifesciences-launches-metabolic-roadinar-to-support-continuing-medical-education-.html https://biospectrumindia.com/news/95/19842/eris-lifesciences-launches-metabolic-roadinar-to-support-continuing-medical-education-.html Tue, 26 Oct 2021 15:55:00 +0530 Ahmedabad-based Eris Lifesciences with Metabolic Health Digest has launched the first edition of the Metabolic Roadinar, an educational travelogue featuring 18 well-known doctors from across the country spread across nine episodes.   The Roadinar has been conceptualised by Dr Rajiv Kovil, diabetologist in Mumbai. The list of 18 doctors who will be a part of this Roadinar includes prominent names such as Dr Ambrish Mithal, Dr Shashank Joshi and Dr Tejas Shah.   The Roadinar features doctors from across cities such as Delhi, Mumbai, Ahmedabad, Bengaluru, Pune, Aurangabad, and Kolkata.   The doctors will be seen discussing varied topics ranging from rediscovering liver as the harbinger of diabetes, COVID- Diabetes- Mucor Mycosis- The boomerang effect of the pandemic, and DPP4 inhibitors + Metformin- VERIFYing extraordinary durability among others.    ]]> <![CDATA[BHEL in CSR partnership with CanKids]]> https://biospectrumindia.com/news/95/19840/bhel-in-csr-partnership-with-cankids.html https://biospectrumindia.com/news/95/19840/bhel-in-csr-partnership-with-cankids.html Tue, 26 Oct 2021 15:40:00 +0530 Bharat Heavy Electricals Ltd (BHEL) announced a CSR partnership with the National Society for Childhood Cancer CanKids KidsCan to achieve access to care for children from 117 aspirational sistricts of India. BHEL will utilise its CSR fund to help children with cancer from the 117 most developmentally challenged districts.This September during the Childhood Cancer Awareness Month out of 117 districts, CanKids together with state govt authorities organised car rallies in 12 districts from six states which include Punjab (Moga and Ferozpur), Uttar Pradesh (Bahraich and Balrampur), West Bengal (Birbhum and Nadia), Bihar (Gaya, Vaishali and Muzaffarpur), Tamil Nadu (Virudhunagar and Ramanathapurãm) and Gujarat (Dohad).Dr Nalin Shinghal, CMD, BHEL said, "CanKids is doing yeoman service for cancer-afflicted children, encompassing the entire spectrum of Childhood Cancer Care. Together, we hope this Access2Care for childhood cancer ADP project will emerge as a best practice patient-centred healthcare success story from these 117 districts.” ]]> <![CDATA[Glenmark brings fixed-dose combination diabetes drug in India]]> https://biospectrumindia.com/news/95/19835/glenmark-brings-fixed-dose-combination-diabetes-drug-in-india.html https://biospectrumindia.com/news/95/19835/glenmark-brings-fixed-dose-combination-diabetes-drug-in-india.html Tue, 26 Oct 2021 09:05:00 +0530 Glenmark Pharmaceuticals has launched a fixed-dose combination (FDC) of its novel, patent-protected,  globally researched Sodium-Glucose Co-Transporter Inhibitor (SGLT2i) - Remogliflozin Etabonate and another widely used DPP4 inhibitor (Dipeptidyl Peptidase 4 inhibitor) – Vildagliptin, with Metformin (first-line medication for the treatment of type 2 diabetes). The fixed drug combination is indicated for the management of Type 2 diabetes. The combination contains Remogliflozin (100 mg) + Vildagliptin (50 mg) + Metformin (500/1000 mg) in a fixed dose and must be taken twice daily to improve glycemic control in patients. Glenmark has launched the same under two brand names Remo MV and Remozen MV. Glenmark is the first company in the world to launch Remogliflozin + Vildagliptin + Metformin fixed-dose combination (FDC) and India is the first country to get access to this FDC drug. Glenmark received approval from the DCGI (the drug approval authority in India) for manufacturing and marketing this fixed dose combination in late September 2021.  Glenmark’s Remogliflozin + Vildagiptin + Metformin combination has been launched at a breakthrough price of Rs. 16.50 per tablet, to be taken twice daily; which amounts to Rs.33.00 as the per-day cost of therapy. This cost is at least 53 per cent lower than the other available SGLT2 & DPP4 combination drugs administered along with Metformin, in India.    ]]> <![CDATA[Hyd-based Jaitra Devices & Systems unveils bipolar air disinfectant and purifier]]> https://biospectrumindia.com/news/95/19828/hyd-based-jaitra-devices-systems-unveils-bipolar-air-disinfectant-and-purifier.html https://biospectrumindia.com/news/95/19828/hyd-based-jaitra-devices-systems-unveils-bipolar-air-disinfectant-and-purifier.html Mon, 25 Oct 2021 08:30:00 +0530 Hyderabad-based Jaitra Devices & Systems has launched bipolar air disinfectant and purifier, in the country.   The device was unveiled by Kishan Reddy, Union Minister of Tourism, Culture and Development of the North Eastern Region of India, who graced the occasion as chief guest at an event in Hyderabad.   The new bipolar air disinfectant and purifier Make in India device can inactivate pathogens like SARS-COV-2 (COVID-19), norovirus, influenza, legionella virus, rhinovirus, Varicella zoster virus, TB bacteria, Staphylococcus bacteria, E coli bacteria, pseudomonas bacteria, Bacillus cereus bacteria, fungi and moulds.   Dr Kasu Prasad Reddy, Co-Chairman, Jaitra Devices & Systems LLP & Co-Chairman & Founder of MaxiVision Eye Hospitals Group said that Jaitra Devices & Systems LLP’s “Bipolar Air Disinfectant & Purifier”, has been testified effective against various pathogens, viruses, bacteria, and fungus.  It is the first-ever Make in India product to adopt the Bipolar Ionization technology, which works against harmful microbes by starting a chemical reaction on the cell membrane surface of the viruses and bacteria making them dead. ]]> <![CDATA[Syngene posts Rs 920M PAT in Q2]]> https://biospectrumindia.com/news/95/19804/syngene-posts-rs-920m-pat-in-q2.html https://biospectrumindia.com/news/95/19804/syngene-posts-rs-920m-pat-in-q2.html Thu, 21 Oct 2021 09:15:00 +0530 Syngene International announced its second-quarter results for FY22. The company has reported quarterly revenue from operations growth of 17 per cent year-on-year to Rs 6,102 million; profit after tax for the quarter, before the exceptional item, increased by 9 per cent year-on-year to Rs 920 million.    Jonathan Hunt, MD and CEO, Syngene International, said, "The second quarter was characterised by positive performances in all divisions. In Discovery Services, we saw excellent client demand, particularly within the emerging biopharma segment, as well as further expansion of our relationships with existing clients and our long-term partners in the dedicated research centres. During the quarter, we continued to manufacture remdesivir for COVID-19, under a voluntary licensing agreement from Gilead. The quarter also saw continued investment in new technologies and the successful implementation of several digitisation and automation projects across our operations. Careful management of costs, coupled with a robust business continuity plan, enabled us to continue to build capability and capacity to meet the growing requirements of our clients." ]]> <![CDATA[Dr Reddy's Labs bags US FDA approval for Lenalidomide caps]]> https://biospectrumindia.com/news/95/19791/dr-reddys-labs-bags-us-fda-approval-for-lenalidomide-caps.html https://biospectrumindia.com/news/95/19791/dr-reddys-labs-bags-us-fda-approval-for-lenalidomide-caps.html Tue, 19 Oct 2021 18:40:00 +0530 Dr  Reddy’s Laboratories announced the final approval of its Abbreviated New Drug Application (ANDA) for Lenalidomide Capsules, in 2.5 mg and 20 mg strengths, and tentative approval for 5 mg, 10 mg, 15 mg, and 25 mg strengths, a therapeutic equivalent generic version of REVLIMID (lenalidomide) Capsules, from the US  Food and Drug Administration (USFDA). With this approval,  Dr Reddy’s is eligible for 180 days of generic drug exclusivity for Lenalidomide capsules, 2.5 mg and 20 mg.   In September 2020,  Dr Reddy’s announced a  settlement agreement of their litigation with  Celgene, the maker of  REVLIMID (lenalidomide) Capsules and a wholly-owned subsidiary of Bristol Myers Squibb, relating to patents for the branded drug.   In settlement of all outstanding claims in the litigation, Celgene agreed to provide Dr Reddy’s with a license to sell volume-limited amounts of generic lenalidomide capsules in the US beginning on a confidential date after March 2022 subject to regulatory approval. The agreed-upon percentages remain confidential. As part of the settlement, Dr Reddy’s is also licensed to sell generic lenalidomide capsules in the US without volume limitation beginning on January 31, 2026.   “We are pleased with the Agency’s approval of Lenalidomide Capsules, 2.5 mg and 20 mg and being eligible for 180-day market exclusivity,” says Marc Kikuchi, CEO, North America Generics, Dr Reddy’s Laboratories.  ]]> <![CDATA[SARVA with PharmEasy to drive adoption of affordable healthcare in India]]> https://biospectrumindia.com/news/95/19789/sarva-with-pharmeasy-to-drive-adoption-of-affordable-healthcare-in-india.html https://biospectrumindia.com/news/95/19789/sarva-with-pharmeasy-to-drive-adoption-of-affordable-healthcare-in-india.html Tue, 19 Oct 2021 17:25:00 +0530 SARVA, India’s yoga-based healthcare ecosystem, has partnered with PharmEasy, to build an all-encompassing healthcare and wellness approach for their customers. The brands are coming together during PharmEasy’s ‘Week of Wellness’ initiative to drive adoption of affordable healthcare in India and give PharmEasy customers the essence of Yoga through SARVA’s meticulously coached and highly experienced trainers from the birthplace of Yoga (Rishikesh).    PharmEasy will be offering discounts on medicines, diagnostic tests and healthcare services. With this initiative, PharmEasy aims to focus on yoga in perfect unison with conventional medicine and alternative therapies combined to make a powerful combination to aid recovery for the end-user.    SARVA’s focus will be on ensuring the management of ailments like diabetes through therapy based Yoga. SARVA will be guiding users to transform their lifestyles to aid with their aliment recovery. The FREE 3- month offering will cover more than 200+ Yoga courses, 250+ meditation courses, 25+ yoga forms, across 3 different intensities (low, medium and high), along with beginner-friendly routines for all.  ]]> <![CDATA[MSN Labs launches affordable diabetes drug EMPAONE]]> https://biospectrumindia.com/news/95/19780/msn-labs-launches-affordable-diabetes-drug-empaone.html https://biospectrumindia.com/news/95/19780/msn-labs-launches-affordable-diabetes-drug-empaone.html Mon, 18 Oct 2021 16:40:00 +0530 MSN Laboratories, based in Hyderabad, has launched empagliflozin tablets (SGLT2i), a promising drug in diabetic management, under the brand name ‘EMPAONE’. The medicine will cost Rs 15.90 and Rs 18.90 for each 10 mg and 25 mg tablet respectively.   ‘EMPAONE’ is intended to provide diabetes patients in need across India with an affordable and accessible therapeutic option. The launch of EMPAONE assumes a critical role particularly for patients suffering from Type 2 diabetes and who were also affected with COVID-19, as diabetes is a major comorbidity factor in such cases.   MSN has developed the Active Pharmaceutical Ingredient (API) & the finished dosage formulation (FDF) of EMPAONE at its in-house state-of-the-art R&D centre. The development is fully indigenous right from conceptualization to API development and FDF. ]]> <![CDATA[Alcon launches intraocular lens AcrySof IQ Vivity in India]]> https://biospectrumindia.com/news/95/19773/alcon-launches-intraocular-lens-acrysof-iq-vivity-in-india.html https://biospectrumindia.com/news/95/19773/alcon-launches-intraocular-lens-acrysof-iq-vivity-in-india.html Sat, 16 Oct 2021 14:25:00 +0530     Bengaluru-headquartered Alcon, a leader in eye care dedicated to helping people see brilliantly, announced the commercial launch of the first and only presbyopia-correcting intraocular lens (PC-IOL) with wavefront-shaping technology – the AcrySof IQ Vivity IOL (Vivity). The new PC-IOL is now available to Indian ophthalmologists for their patients undergoing cataract surgery. Cataracts usually impact older adults and are often linked to presbyopia, which reduces the ability to view near objects and is the most common refractive disorder in patients undergoing cataract surgery.   Vivity is the first and only extended depth of focus lens with Alcon’s proprietary X-WAVE technology, which stretches and shifts light without splitting it. Vivity delivers a continuous range of vision at various distances like monofocal-quality distance (far) with excellent intermediate (at arm’s length, e.g., reading the newspaper, working on a laptop) and functional near (up close, e.g., reading books, mobile phone), with a clinically proven exceptionally low rate of visual disturbances.     Commemorating World Sight Day on October 14, Vivity aims to meet the needs of cataract patients interested in enhanced visual performance, reduced spectacle dependence while enabling for more independence.   Vivity expands Alcon’s growing portfolio of PC-IOLs and is built on Alcon’s trusted and proven AcrySof IQ IOL platform with implants exceeding 125 million eyes globally. According to results from two large independent clinical trials, patients who had the Vivity lens implanted experienced renewed vision and lifestyle benefits. Vivity patients reported 20/20 vision at a distance, more than 20/25 at intermediate and 20/32 for near vision.   ]]> <![CDATA[WHO acknowledges Cipla as leading partner in fight against NCDs]]> https://biospectrumindia.com/news/95/19771/who-acknowledges-cipla-as-leading-partner-in-fight-against-ncds.html https://biospectrumindia.com/news/95/19771/who-acknowledges-cipla-as-leading-partner-in-fight-against-ncds.html Thu, 14 Oct 2021 15:05:00 +0530 Recognising Cipla’s active and consistent role in tobacco cessation in India, the Director-General of WHO Tedros Adhanom Ghebreyesus commended Cipla as a leading partner in the prevention of NCDs (Non-communicable diseases). The announcement was made at the recent global UN conference on Meeting the non-communicable diseases and mental health-related SDG target around World Lung Day.    The community-level outreach interventions, like those in Maharashtra, Madhya Pradesh, Goa and Karnataka are implemented under NCDC (Non-Communicable Disease Control) programmes. Cipla, under innovative public-private partnerships, works on a mission mode in different programme components. Counselling, integrating tobacco cessation at primary healthcare, intersectoral linkages, sensitising youth, training of trainers and capacity building of health care professionals and workers are some of its key focus areas.    Shivam Puri, CEO – Cipla Health says, “Globally, WHO and Cipla Health have partnered in various programmes, including the donation of Nicotex patches and gums in Timor Leste where it has played a crucial role in limiting the use of tobacco through the use of acceptable alternatives. Our efforts have been consistent since day one and we feel honoured to be recognised by World Health Organisation although we have a long way to go.”   ]]> <![CDATA[HCTI raises $15M in funds, eyes growth strategies]]> https://biospectrumindia.com/news/95/19764/hcti-raises-15m-in-funds-eyes-growth-strategies.html https://biospectrumindia.com/news/95/19764/hcti-raises-15m-in-funds-eyes-growth-strategies.html Wed, 13 Oct 2021 15:25:00 +0530 SecureKloud Technologies (SecureKloud), a global leader in cloud solutions has announced the approval to list its step-down subsidiary Healthcare Triangle Inc. (HCTI) in NASDAQ, marking a milestone moment for the Chennai-based IT and cloud solutions company.   HCTI, launched in 2019 with headquarters in Pleasanton, California, is gaining momentum in the rapidly growing healthcare information technology segment, providing solutions in the areas of cloud services, data science, and professional and managed services for the healthcare and Life Sciences industry.   Through this IPO, HCTI is raising a total of $15 million including an over-allotment of $2 million. The IPO proceeds will be utilised for potential acquisitions (although the company has no current plans, arrangements or agreements for any acquisitions), working capital, research and development, and general corporate investments. The company’s growth strategies reflect the mission, to be the pioneer for massive, measurable, data-informed healthcare improvement. The healthcare cloud industry is worth a total addressable market of $300 billion. Bloomberg business report estimates that the global market for healthcare data science and analytics will be $40B by 2025 with a CAGR of 23.5 per cent. To capitalise on this opportunity, HCTI will focus growth through our software as a service (SaaS) subscription model for CloudEz, DataEz and Readabl.AI platforms.   “Our goal is to become among the top 10 healthcare IT companies in North America and we believe, this will unlock significant value over the next few years,” added Suresh Venkatachari, Chairman and CEO, SecureKloud and HCTI.   Thyagarajan R, CFO, SecureKloud and HCTI, stated that Nasdaq is a preferred marketplace for Technology companies driving innovation. ]]> <![CDATA[Intas launches world's first SB-100mg Itraconazole]]> https://biospectrumindia.com/news/95/19761/intas-launches-worlds-first-sb-100mg-itraconazole.html https://biospectrumindia.com/news/95/19761/intas-launches-worlds-first-sb-100mg-itraconazole.html Wed, 13 Oct 2021 10:25:00 +0530 Ahmedabad-based Intas Pharmaceuticals has launched Super Bioavailable Itraconazole-SB 100mg by the Brand Name of Itaspor-SB Forte/Subawin. It has been recently approved by Indian Regulatory Authorities.   Conventional Itraconazole mainstay drug to fight fungal infection has high result variance and low patient compliance because of dosing dependence upon food, acidic beverage, antacids consumption etc. and overall cost of treatment.    Itaspor SB Forte/Subawin is expected to improve patient compliance and reduce the Doctor's counselling time. It will reduce dosing to half. Furthermore, patients can take it with or without a meal with just water or as directed by the physician. The cost of the therapy is also reduced substantially.    "Intas' newest formulation within the 25-year-old brand Itaspor is formulated with Super Bioavailable (SB) Technology that makes 1 Itaspor-SB Forte capsule equivalent to conventional 200mg Itraconazole," said Dr Alok Chaturvedi, Senior VP and Head - Medical Affairs, Intas Pharmaceuticals.     ]]> <![CDATA[Krsnaa Diagnostics registers Rs 241 Cr revenue from operations in H1FY2022]]> https://biospectrumindia.com/news/95/19753/krsnaa-diagnostics-registers-rs-241-cr-revenue-from-operations-in-h1fy2022.html https://biospectrumindia.com/news/95/19753/krsnaa-diagnostics-registers-rs-241-cr-revenue-from-operations-in-h1fy2022.html Tue, 12 Oct 2021 12:15:00 +0530 Krsnaa Diagnostics has announced the results for the first six months ending September 30, 2021, following its listing on the stock exchanges on August 16, 2021. In H1FY2022, revenue from operations has been registered at Rs 241 crores, up 19 per cent y-o-y. The company posted, EBITDA of Rs 74 crores, up 76 per cent y-o-y. EBITDA margins increased to 30.9 per cent in H1 FY22 as compared to 20.9 per cent in H1 FY21. Profit After Tax without CCPS was at Rs 34 crores, up by 167 per cent with margins of 13.8 per cent. Net cash position was at Rs 326 crores at the end of September 2021.   Core business i.e. radiology and pathology registered a revenue increase of 143 per cent y-o-y, which was partially offset by a decline of 75 per cent during COVID-19. The core business contribution was 89 per cent whereas COVID-19 business contributed 11 per cent to the total revenues in H1 FY22.   Yash Mutha, Executive Director, Krsnaa Diagnostics said, "The year 2021 marks a significant milestone for Krsnaa Diagnostics in its growth story, the as the company went public in August 2021. I would like to thank all our employees, partners and shareholders who have showed confidence in our business model and joined us in fulfilling our mission ‘To make a difference in the healthcare diagnostic industry." ]]> <![CDATA[Aster Labs unveils advanced pathology lab in Mangaluru]]> https://biospectrumindia.com/news/95/19744/aster-labs-unveils-advanced-pathology-lab-in-mangaluru.html https://biospectrumindia.com/news/95/19744/aster-labs-unveils-advanced-pathology-lab-in-mangaluru.html Mon, 11 Oct 2021 14:40:00 +0530 Aster Labs has announced the launch of its pathology lab in Mangaluru, located in Guru Deep House, Kadri. The lab is spread across 1500 sq ft and offers more than 2,500 tests ranging from routine to specialised tests.    Aster Labs will offer diagnostics services ranging from routine test investigations like blood tests, urine tests, stool tests, biopsy tests to the more advanced tests on biochemistry, haematology, microbiology, clinical pathology, histopathology, cytogenetics, molecular diagnostics and flow cytometry and will provide trustworthy, reliable, high quality, affordable and accurate reports to the patients consistently.    As a part of its growth strategy and expansion plan. Aster Clinical Lab has already launched one reference lab, six satellite labs and 38 patient experienced centres, spread across Bangaluru and Kerala. Aster Labs will also be looking to launch 12 more satellite labs by the coming months. The company plans to set up 20 satellite labs across the country by mid-2022.   ]]> <![CDATA[DocMode's e-dialogue series GAPSULE to address covid induced knowledge between physicians, pharma sector]]> https://biospectrumindia.com/news/95/19738/docmodes-e-dialogue-series-gapsule-to-address-covid-induced-knowledge-between-physicians-pharma-sector.html https://biospectrumindia.com/news/95/19738/docmodes-e-dialogue-series-gapsule-to-address-covid-induced-knowledge-between-physicians-pharma-sector.html Mon, 11 Oct 2021 11:00:00 +0530 DocMode launched GAPSULE, the first-of-its-kind e-dialogue series to address covid-induced knowledge and the relationship gap between physicians and the pharmaceutical industry. GAPSULE is an effort to find a workable solution to equip physicians with the latest information about medical development through intense R&D.   Hans Lewis, Founder and CEO, DocMode, said, “Social distancing and other norms have limited the scope of physical interaction between physicians and medical representatives resulting in the knowledge and relational gap. GAPSULE is an effort to find a workable solution to bridge this gap and DocMode, facilitates such a process by bringing together different stakeholders on its platform.”    “The first session of GAPSULE saw various pharmaceutical companies coming together. They discussed knowledge and relationship, shared their experience and exchanged different ideas. The response to GAPSULE has been received well,” added Lewis.   Dr Mahesh Abhyankar, Vice President, USV and author of Emozeal, noted that major hospitals became no-entry zones to medical representatives with the outbreak of the coronavirus resulting in interaction deficit which has the potential to affect treatment outcome.   “I can understand the concern of hospitals. It is very genuine. But it does not mean that we should live with the issue compromising patient satisfaction. I am happy DocMode has taken this initiative which is the need of the hour,” said Dr Abhyankar.   The upcoming GAPSULE sessions would be more interesting since they would include physicians, pharmaceutical companies and other stakeholders. “Hopefully, we should succeed in finding a solution that is best-suited for all,” Lewis said.   Subhojit Mukherjee, SBU Head Sales & Marketing, Akumentis Healthcare felt customer relation was evolving into customer value. “In this transitional phase, doctors prefer to meet companies who add value to their practice and patients. GAPSULE will help this transition,” he noted.     Nikhil Dhamne, Business Unit Head, Sun Pharma Laboratories, said "It is not about showing a brand or my face. Visibility is the uninterrupted passage of information." ]]> <![CDATA[Glenmark launches dry powder inhaler Tavulus in Spain]]> https://biospectrumindia.com/news/95/19737/glenmark-launches-dry-powder-inhaler-tavulus-in-spain.html https://biospectrumindia.com/news/95/19737/glenmark-launches-dry-powder-inhaler-tavulus-in-spain.html Mon, 11 Oct 2021 09:10:00 +0530 Mumbai-based Glenmark Pharmaceuticals has launched a bioequivalent version of Tiotropium Bromide dry powder inhaler (DPI) under the brand name Tavulus in Spain, for the treatment of chronic obstructive pulmonary disease (COPD).Studies show that close to 2.5 million people suffer from COPD in Spain. Tavulus is expected to provide relief to a large patient population in the country. It is a long-acting bronchodilator that helps to open the airways and makes it easier for air to get in and out of the lungs. It also works to prevent sudden, short-term worsening of COPD symptoms.Commenting on the launch, Vice President - Business Development of Glenmark Pharmaceuticals, Dr Jiří Havránek, says, “This inhalation therapy has been shown to significantly aid in the daily management of COPD. We hope that it improves both COPD symptoms and quality of life in those who are most affected.”In November 2017, a Glenmark European subsidiary entered into a strategic, exclusive in-licensing arrangement for marketing generic Tiotropium Bromide DPI in Western Europe and the UK. Glenmark is planning subsequent launches of the product across these markets under the brand name Tiogiva in the UK, Ireland, Sweden, Finland and Norway; Tavulus in Denmark and Netherlands; and Tiotropium Glenmark in Germany. ]]> <![CDATA[HCAH SuVitas to see Rs 200 to 300 Cr worth investment in capacity expansion]]> https://biospectrumindia.com/news/95/19719/hcah-suvitas-to-see-rs-200-to-300-cr-worth-investment-in-capacity-expansion.html https://biospectrumindia.com/news/95/19719/hcah-suvitas-to-see-rs-200-to-300-cr-worth-investment-in-capacity-expansion.html Thu, 07 Oct 2021 11:55:00 +0530 Hyderabad-based SuVitas, a transition care start-up, was recently acquired by Delhi NCR-based healthcare outside hospital pioneer HCAH backed by the Burmans of Dabur Group and Quadria Capital. HCAH plans to invest around Rs 200-300 crores in HCAH SuVitas to expand its capacity across India (Delhi NCR, Mumbai, Bengaluru, Kolkata, Hyderabad, Chennai, Pune and Ahmedabad) by adding 1500 beds in 30 transition care centres in over next two to three years.Vivek Srivastava, Co-Founder & CEO – HCAH said, ‘’We are happy to announce that we are committed to increasing transition care bed capacity from 100 beds to 1500 beds. We will further strengthen our presence in all major metro cities.”Antra Bhargava, CEO, HCAH SuVitas said, “HCAH SuVitas through expansion would be able to help many more patients in need and ease the burden on tertiarycare hospitals.”  ]]> <![CDATA[Bayer to invest over €400 M for access to modern contraception]]> https://biospectrumindia.com/news/95/19708/bayer-to-invest-over-400-m-for-access-to-modern-contraception.html https://biospectrumindia.com/news/95/19708/bayer-to-invest-over-400-m-for-access-to-modern-contraception.html Wed, 06 Oct 2021 12:55:00 +0530 Bayer will invest over €400 million, reinforcing its commitment to providing 100 million women and girls with access to family planning by 2030, especially in low- and middle-income countries (LMICs). This investment will include the expansion of production capabilities in Turku, Finland and the construction of a new production site in Alajuela, Costa Rica.   In Costa Rica, Bayer will build a new state-of-the-art production facility, specialised in the production and supply of LARCs. The new production plant at Coyol Industrial Park, Alajuela, Costa Rica, is expected to start the supply of long-acting reversible contraceptives to LMICs by 2024.   The company will also invest substantially in building a new facility and expanding its production capabilities in Turku, Finland, as announced earlier this year. Upon completion by 2025, the new production facility will boast the latest technology, leveraging automation and robotics to produce long-acting reversible contraceptives.   Both sites will produce hormonal implants and hormonal intrauterine systems (IUS), supporting Bayer to achieve its global sustainability goal of providing 100 million women and girls in LMICs with access to family planning by 2030. The investment will also support Bayer, a leader in women’s healthcare with an innovative and successful IUS product portfolio, in strengthening its commercial supply chain. ]]> <![CDATA[Uniza Group unveils Vitellus lotion to treat Vitiligo]]> https://biospectrumindia.com/news/95/19697/uniza-group-unveils-vitellus-lotion-to-treat-vitiligo.html https://biospectrumindia.com/news/95/19697/uniza-group-unveils-vitellus-lotion-to-treat-vitiligo.html Mon, 04 Oct 2021 14:55:00 +0530 Ahmedabad-based Uniza Healthcare has launched a novel treatment for the management of Vitiligo, a pigmentary skin disorder, in Indian market.   The company has launched a lotion - Vitellus, a unique combination of Greyverse, Melitane GL 200 & EUK-134 in tie-up with a Canadian company - Lucas Meyer Cosmetics and Indian company Amvigor Organics. The company has recently received WHO GMP Certification for its Kadi Plant.    Vitellus lotion is a 3 in 1 solution and helps in growth of melamine and works on skin pigmentation, hair follicle pigmentation and also as a super antioxidant. Greyverse stimulates melanogenesis and pigmentation and decreases in oxidative stress, EUK - 134 decreases oxidative stress and H2O2 Production while Melitane helps in promoting re-pigmentation of skin by stimulating melanogenesis and decreasing inflammation.    Sreekanth Seshadri, CEO and Managing Partner, Uniza Healthcare, said, "Vitellus is an advanced solution for the management of Vitiligo as compared to currently available. Company is looking to introduce more innovative products in India."   "Our international business would mainly focus on ROW markets like Africa, LATAM, South East Asia and CIS countries and planning to file over 180 dossiers. Our Indian business is aiming to achieve sales of Rs 100 crore in FY 2021-22," said Saurin Parikh, MD, Uniza Group & Founder, Pashupati Group. ]]> <![CDATA[Max Healthcare expands in NCR region, to add 1000+ beds in Gurugram ]]> https://biospectrumindia.com/news/95/19695/max-healthcare-expands-in-ncr-region-to-add-1000-beds-in-gurugram-.html https://biospectrumindia.com/news/95/19695/max-healthcare-expands-in-ncr-region-to-add-1000-beds-in-gurugram-.html Mon, 04 Oct 2021 13:45:00 +0530 Max Healthcare Institute Limited (MHIL) is expanding its bed capacity in NCR region by addition of two hospitals of ~500 beds each in Gurugram. This will significantly ramp up its existing footprint in NCR region and help serve the healthcare needs of ever-expanding communities in Gurugram.    Two land parcels measuring ~6.11 acres and ~5.26 acres are being allotted by HSVP (Haryana Shahri Vikas Pradhikaran) post successful bid by the Company in a recent HUDA auction and are located in the heart of Gurugram abutting well populated areas of Sectors 53 on the Golf Course Road and Sector 56. At present, Max Healthcare runs a multi-specialty Hospital in Sector 43, Gurugram.     Dr Abhay Soi, Chairman and MD, Max Healthcare said, “The two newly acquired land parcels will be constructed in a phased manner, adding ~1,000 beds over the next four to six years and will further strengthen our presence in NCR.”    ]]> <![CDATA[Eli Lilly partners with Cipla for key diabetes products]]> https://biospectrumindia.com/news/95/19691/eli-lilly-partners-with-cipla-for-key-diabetes-products.html https://biospectrumindia.com/news/95/19691/eli-lilly-partners-with-cipla-for-key-diabetes-products.html Mon, 04 Oct 2021 10:25:00 +0530 Gurugram headquartered Eli Lilly and Company (India) has announced its strategic partnership in India to enhance the reach of Lilly’s Diabetes products – Humalog [Insulin Lispro IP (rDNA Origin) injection] and Trulicity (Dulaglutide).   As a part of this agreement, Lilly will transfer its rights in India to sell, promote and distribute the aforesaid two Lilly diabetes products – Humalog and Trulicity to Cipla, subject to all regulatory approvals.    Lilly will continue to maintain its existing operating model for the remaining portfolio of products. Cipla will leverage its capabilities and robust distribution strengths to engage healthcare professionals and expand access to these treatments for patients who need them.    Commenting on the partnership, Luca Visini, MD, India Subcontinent, Lilly India, said, “Developing strategic partnerships to adopt different operating models is key to enabling Lilly’s global efforts to make innovative medicines available to more people in India and around the world.”  ]]> <![CDATA[Clevergene acquires NovaSeq 6000 DNA Next Gen Sequencer]]> https://biospectrumindia.com/news/95/19689/clevergene-acquires-novaseq-6000-dna-next-gen-sequencer.html https://biospectrumindia.com/news/95/19689/clevergene-acquires-novaseq-6000-dna-next-gen-sequencer.html Mon, 04 Oct 2021 00:00:00 +0530 Bengaluru-based Clevergene has scaled up its sequencing capacity with the Illumina Novaseq 6000. The advanced platform from the global genomics leader, Illumina, is an innovation-driven performer and can sequence 50-60 human genomes in <2 days.   The sturdy platform ensures no compromise in the data quality, cherry on top is the per GB sequencing and reagent chemistry cost drastically falling.   Tony Jose, CEO, Clevergene stated, “Genomics is taking the central stage in life sciences research and there is no better time than now to invest in the NovaSeq 6000 platform which is coveted as the world’s most advanced DNA sequencer. The NovaSeq will significantly bolster Clevergene’s position in Discovery genomics and genetic diagnostics markets. We aim to undertake large global genomics projects involving hundreds of samples and specialised applications such as single-cell gene expression that require a significantly high amount of sequence data. We are also expanding our footprint in paediatric genetic disease diagnostics, non-invasive prenatal testing and carrier screening with the scaled-up sequencing capacity.”     ]]> <![CDATA[Kyrgyzstan invites Indian pharma companies to set-up units]]> https://biospectrumindia.com/news/95/19687/kyrgyzstan-invites-indian-pharma-companies-to-set-up-units.html https://biospectrumindia.com/news/95/19687/kyrgyzstan-invites-indian-pharma-companies-to-set-up-units.html Fri, 01 Oct 2021 00:00:00 +0530 Indian pharmaceutical companies are being offered free land and power in Kyrgyzstan to set up their manufacturing facilities. This information was shared by Asein Isaev, Ambassador, Embassy of Kyrgyzstan.   “Our government is willing to provide free land and electricity to Indian pharma companies willing to set up a plant in Kyrgyzstan,” the Ambassador said speaking at an interactive session organised jointly by the Visvesaraya Industrial Research and Development Centre (MVIRDC) World Trade Center Mumbai, All India Association of Industries (AIAI) and Indian Chamber of International Business (ICIB).   There is a blanket tax holiday for the first five years and companies located in Kyrgyzstan enjoy preferential market access to a population of more than 1 billion across Central Asia, CIS, European Union and other countries, he said adding that so far Indian pharmaceutical companies have signed over 35 joint ventures with the Central Asian nation.   The new Kyrgyzstan government is committed to protecting the interests of foreign investors, who can open a company in just two steps and can get all mandatory licenses in eight days, Isaev said.   Dr Vijay Kalantri, Chairman, MVIRDC World Trade Center Mumbai said, “We should resolve to triple India-Kyrgyzstan bilateral trade volume in the next three years as the current level of $44 million is below the true potential.”   ]]> <![CDATA[SpiceHealth launches pathology testing services in Delhi]]> https://biospectrumindia.com/news/95/19675/spicehealth-launches-pathology-testing-services-in-delhi.html https://biospectrumindia.com/news/95/19675/spicehealth-launches-pathology-testing-services-in-delhi.html Thu, 30 Sep 2021 13:00:00 +0530 SpiceHealth has decided to foray into pathology laboratory services launching its first state-of-the-art pathology lab at Sama Hospital, Siri Fort Road, New Delhi. The pathology lab will offer a wide range of affordable testing like haematology, clinical pathology, biochemistry, Complete Blood Count (CBC), liver function test, kidney function test, lipid profile, blood sugar, urine routine etc. The lab will offer sample collections through walk-in, home collection and corporate collection.   SpiceHealth’s path lab is equipped with advanced facilities and will have a team of highly qualified professionals including dedicated pathology staff, experienced technicians and a dependable home collection team. SpiceHealth aims to disrupt the path lab space in India by making services easily accessible and affordable for the general public. The company will leverage its robust IT infrastructure built in-house, to ensure the quality, reliability and scalability of offering essential healthcare services.  ]]> <![CDATA[Glenmark bags marketing approval for Ryaltris in 13 countries across EU, UK]]> https://biospectrumindia.com/news/95/19669/glenmark-bags-marketing-approval-for-ryaltris-in-13-countries-across-eu-uk.html https://biospectrumindia.com/news/95/19669/glenmark-bags-marketing-approval-for-ryaltris-in-13-countries-across-eu-uk.html Thu, 30 Sep 2021 10:30:00 +0530 Glenmark Pharmaceuticals has received marketing approval for its fixed-dose combination nasal spray Ryaltris in 13 countries across the EU and UK. Glenmark is set to launch Ryaltris directly in the markets of Czech Republic, Slovakia, Poland, and the UK. Ryaltris will be marketed in the rest of Europe by the Menarini Group as part of its exclusive licensing agreement with Glenmark.     Ryaltris (olopatadine 665 μg and mometasone furoate 25 μg), is indicated for symptomatic treatment of seasonal and perennial allergic rhinitis in adults and children over 12 years of age.    Commenting on this development, Robert Crockart, Chief Commercial Officer, Glenmark Pharmaceuticals said, “The marketing approval will pave the way for the effective and timely treatment of allergic rhinitis for thousands of patients across Europe. We are already seeing its therapeutic benefits in other regions where Ryaltris has been launched, and we hope to extend this relief to more people across the world.”     Glenmark has also partnered with Hikma Pharmaceuticals and Bausch Health for the commercialisation of Ryaltris in the US and Canada respectively. In April this year, Glenmark concluded the DCP regulatory  procedure in Europe, enabling approval in 17 countries across the EU and the UK.    ]]> <![CDATA[Doceree launches opti-channel marketing for pharma sector]]> https://biospectrumindia.com/news/95/19647/doceree-launches-opti-channel-marketing-for-pharma-sector.html https://biospectrumindia.com/news/95/19647/doceree-launches-opti-channel-marketing-for-pharma-sector.html Tue, 28 Sep 2021 13:15:00 +0530 Doceree has launched opti-channel marketing for the pharmaceutical sector. Pharma brands can now showcase a single message to physicians on multi-channel – display email and SMS, pronouncing greatly the impact of digital messaging campaigns.Additionally, the company’s revamped platform will provide increased transparency to pharma brands that are facing a herculean challenge in having a genuine and transparent view on the performance of their campaigns being run on individual digital sites. The real-time dashboard provides marketers valuable insights on channel performance that they can use to make informed decisions.Doceree’ enhanced platform features provide pharma brands with a holistic view of a healthcare provider’s journey, giving a transparent and in-depth view of campaign metrics from a physician engagement level. The company aims to improve the overall business outcomes of pharma brands on digital with its latest opti-channel marketing approach. “We have moved beyond that stage to address peculiar issues that are crippling the penetration of digital in the industry. Our product aims to establish while allowing pharma brands to have complete transparency on digital messaging campaigns,” said Dr Harshit Jain, Founder and Global CEO, Doceree. ]]> <![CDATA[Sun Pharma launches cough syrup Chericof 12 in India]]> https://biospectrumindia.com/news/95/19646/sun-pharma-launches-cough-syrup-chericof-12-in-india.html https://biospectrumindia.com/news/95/19646/sun-pharma-launches-cough-syrup-chericof-12-in-india.html Tue, 28 Sep 2021 12:50:00 +0530 Sun Pharmaceutical Industries announced the launch of a novel formulation in cough management - Chericof 12 (Dextromethorphan Hydrobromide 30 mg and Chlorpheniramine Maleate 4 mg) in India. Chericof 12, the first prescription cough syrup in India which gives relief for up to 12 hours, is manufactured using Polistirex technology for sustained release of the drug. Chericof 12 is approved for patients of age group six years and above.   The Polistirex technology used in Chericof 12 provides sustained release of the medicine in the body, thus offering up to 12-hour relief to patients with twice-daily dosage.    Kirti Ganorkar, CEO – India Business, Sun Pharma said, “At Sun Pharma, we always endeavour to introduce differentiated medicines that enhance convenience or solve patients’ problems, thus helping them to cope better with their ailments. The Polistirex technology used in Chericof 12 helps in improving patient compliance and avoids the need for frequent dosing.”    Polistirex Technology involves the complexation of two drugs, Dextromethorphan Hydrobromide and Chlorpheniramine maleate with resins. The resin granules of both drugs are added in suspension to form Chericof 12. Complexation of drugs with polistirex not only provides sustained release but also masks the bitter taste making it more palatable.  ]]> <![CDATA[Alkem Labs launches lung care division, Pulmocare]]> https://biospectrumindia.com/news/95/19644/alkem-labs-launches-lung-care-division-pulmocare.html https://biospectrumindia.com/news/95/19644/alkem-labs-launches-lung-care-division-pulmocare.html Tue, 28 Sep 2021 10:50:00 +0530 Mumbai-based pharma firm Alkem Laboratories has launched Pulmocare, a division to enhance awareness, diagnosis and management for lung diseases like asthma, COPD, allergy, advanced lung diseases and lung infections through a wide range of products for lung care. The objective is to bring a drastic change in lung treatment accessibility in India by way of early diagnosis, better patient reach and signified health promotion. Sandeep Singh, MD, Alkem Laboratories, stated. “Taking the stock of filling the massive gap of accessibility of lung care for the larger populace in India, we have decided to take a big leap to address the huge lung diseases burden in the country by launching a comprehensive lung care division – Pulmocare. With the Alkem launch of the Pulmocare division, we shall spread awareness about the disease amongst the patients and encourage them to use correct medication.” ]]> <![CDATA[Intas Pharma launches leukaemia drug Azadine-O]]> https://biospectrumindia.com/news/95/19628/intas-pharma-launches-leukaemia-drug-azadine-o.html https://biospectrumindia.com/news/95/19628/intas-pharma-launches-leukaemia-drug-azadine-o.html Fri, 24 Sep 2021 18:40:00 +0530 Ahmedabad-based Intas Pharmaceuticals has launched oral azacitidine in India under the brand name Azadine-O.   Oral Azacitidine is approved for use in maintenance therapy for adult patients with Acute Myeloid Leukaemia.   It is the first drug that will improve survival by almost ten months and bridge a long-pending unmet need in cancer therapy.   Prof (Dr) MB Agarwal, shared his views about the launch, saying, "Oral Azacitidine will prove to be extremely useful for AML patients. There was a dire need for this drug. It shall significantly improve survival and quality of life of patients."   ]]> <![CDATA[Pharma IPR 2021 discuss ways to create efficient IP framework ]]> https://biospectrumindia.com/news/95/19626/pharma-ipr-2021-discuss-ways-to-create-efficient-ip-framework-.html https://biospectrumindia.com/news/95/19626/pharma-ipr-2021-discuss-ways-to-create-efficient-ip-framework-.html Fri, 24 Sep 2021 18:20:00 +0530 Informa Pharma Intelligence, the Knowledge Partner of Pharma IPR 2021, concluded the 10th Annual Pharma IPR India Conference in congregation with Informa Pharma Intelligence. The theme for the conference was ‘Ideate and Innovate.’ The event witnessed an exchange of thoughts to create an efficient IP framework globally to bolster the potential of growth, investments, and collaboration amid crises.   Poornachandra Tejasvi, Senior Director, Emerging Markets, India, at Informa Pharma Intelligence said, “The Pharma IPR India Conference is an innovative platform to motivate researchers and IP professionals to explore new areas of pharma and biotech innovation, with modern intellectual property strategies, policies, and strong protection are extremely essential, especially amidst the crisis we are in.”   Yogesh Mudras, MD, Informa Markets in India, said, “Recent challenges over patents for varied newer drugs has emphasised that advancement is still required in balancing the opposing forces of innovation through the protection of IP rights, versus the provision of affordable drugs for the emerging geographical regions across the globe. IP is the backbone to ensure the development of new drugs and is extremely vital to improvise patient care, spurring economic growth and intensifying the innovation economy. To motivate researchers to explore new areas of medical innovation, modern IP systems and strong protections are crucial."   This conference created a common platform for all key stakeholders, IP/Patent leaders from across India and law firms from across the globe. Based on Informa Pharma Intelligence’s ‘Indian Biosimilars Report’, India leads the way with 127 products, which is the highest number of approved biosimilars compared to other major regions. This is expected to grow further and is likely to shape the next decade for the Indian biosimilars market through intensive portfolio management decisions, pricing, manufacturing prospects, clinical trials and government support.    The notable members of the advisory board and speakers were Prathiba M Singh, Justice, Delhi High Court, Jacqueline Wright Bonilla, Deputy Chief Administrative Patent Judge, Patent Trial and Appeal Board (PTAB), US Patent and Trademark Office.  ]]> <![CDATA[Metropolis Healthcare unveils 750 sq ft testing centre in Nashik]]> https://biospectrumindia.com/news/95/19624/metropolis-healthcare-unveils-750-sq-ft-testing-centre-in-nashik.html https://biospectrumindia.com/news/95/19624/metropolis-healthcare-unveils-750-sq-ft-testing-centre-in-nashik.html Fri, 24 Sep 2021 16:55:00 +0530 Metropolis Healthcare has launched a new testing centre in Nashik, Maharashtra. The 750 sq ft laboratory can conduct around 30,000 sample testing per month with a quick turnaround time and high-quality reports. The chief guest for the launch was Dr Avesh Pallod, Additional Commissioner, Municipal Corporation, Nashik. Metropolis Laboratory, Nashik, will offer about 80+ different tests ranging from basic day to day pathology tests to high-end molecular diagnostics tests. Dr Manoj Patel, Head of Dr Patel Metropolis Lab in Nashik, Metropolis Healthcare, said “We are proud to announce the launch of our new processing lab at Nashik Road. Metropolis Healthcare has been serving the people of Nashik for more than a decade now. During the beginning of COVID-19, we catered to more than 50,000 patients."Vijender Singh, CEO, Metropolis Healthcare said about the launch, “In addition to our existing labs, we are elated to announce the launch of our new testing laboratory in Nashik, Maharashtra. While the pandemic continues to be in the shadow, our constant aim has been to expand to more cities across India and always be available for everyone on a real-time basis. The team working at the lab works day-in-day-out to ensure perfection of the highest order.”The new laboratory is located at Shop No. 4 & 5, Ground floor, Durga Apartment, Artillary Centre Road, Near Durga Udyan, Nashik Road, Nashik – 422101.  ]]> <![CDATA[Serum Institute, Novavax submit COVID-19 vaccine emergency use listing to WHO]]> https://biospectrumindia.com/news/95/19622/serum-institute-novavax-submit-covid-19-vaccine-emergency-use-listing-to-who.html https://biospectrumindia.com/news/95/19622/serum-institute-novavax-submit-covid-19-vaccine-emergency-use-listing-to-who.html Fri, 24 Sep 2021 13:10:00 +0530 Pune-based Serum Institute of India (SII) and its US-based partner Novavax, have announced a regulatory submission to the World Health Organization (WHO) for emergency use listing (EUL) of Novavax' recombinant nanoparticle protein-based COVID-19 vaccine candidate with Matrix-M adjuvant.  The grant of EUL by the WHO is a prerequisite for exports to numerous countries participating in the COVAX Facility, which was established to allocate and distribute vaccines equitably to participating countries and economies. In addition to the submission for WHO EUL, SII and Novavax last month completed the submission of modules required by regulatory agencies in India, Indonesia and the Philippines for the initiation of a review of the vaccine, including preclinical, clinical, and chemistry, manufacturing and controls (CMC) data. NVX-CoV2373 is a protein-based vaccine candidate engineered from the genetic sequence of the first strain of SARS-CoV-2. ]]> <![CDATA[BDR Pharma launches BIAPENEM to treat patients with intra-abdominal infections]]> https://biospectrumindia.com/news/95/19621/bdr-pharma-launches-biapenem-to-treat-patients-with-intra-abdominal-infections.html https://biospectrumindia.com/news/95/19621/bdr-pharma-launches-biapenem-to-treat-patients-with-intra-abdominal-infections.html Fri, 24 Sep 2021 12:40:00 +0530 BDR Pharma has launched BIAPENEM to treat patients with intra-abdominal infections, lower respiratory infections, or complicated urinary tract infections. The drug will be available in the market shortly.     BDR Pharma was the first to identify and develop this product and conducted clinical studies in conjunction with some of the leading players in the critical care segment who co-sponsored these studies. BDR Pharma was also the first one to get the DCGI (Drug Controller General of India) approval for this drug.    Raheel Shah, Director – Business Development, BDR Pharmaceuticals, said, “The drug will cover a broad spectrum of almost every infection and will be a great boon to the medical fraternity and patients. Firmly following the path of accessible and affordable care, we have categorically decided to market this wonder product and we will make arrangements to supply the product to the co-sponsors who will also market it under their brand name. We aim to meet the demand of every patient while maintaining the highest quality during these critical times through improved medical solutions.”   Biapenem is mainly prescribed to patients with intra-abdominal, lower respiratory or complicated urinary tract infections. It belongs to a critical parenteral carbapenem antibacterial agent. However, the dosage of BIAPEN is much lesser as compared to the existing class of Carbapenems. Thereby reducing the dosage quantity showing good clinical and bacteriological efficacy. Biapenem is widely distributed and penetrates well into various tissues (e.g. lung tissue) and body fluids (e.g. sputum, pleural effusion, abdominal cavity fluid). ]]> <![CDATA[DCGI approves use of inhaled Ampion for COVID-19-related respiratory distress]]> https://biospectrumindia.com/news/95/19611/dcgi-approves-use-of-inhaled-ampion-for-covid-19-related-respiratory-distress.html https://biospectrumindia.com/news/95/19611/dcgi-approves-use-of-inhaled-ampion-for-covid-19-related-respiratory-distress.html Wed, 22 Sep 2021 16:00:00 +0530 US-based Ampio Pharmaceuticals has announced regulatory approval from the Drugs Controller General of India (DCGI) of the Central Drugs Standard Control Organization (CDSCO) in the Phase II AP-019 clinical trial in India.   The study will utilise inhaled Ampion to treat those suffering from respiratory distress due to COVID-19.   Following the presentation of Ampion to a Subject Expert Committee (SEC) established by the DCGI, the AP-019 treatment protocol was approved with no recommended changes.   The company initiated the AP-019, double-blind, placebo-controlled Phase II trial, utilizing inhaled Ampion following the strong top-line results achieved from its AP-014 Phase I trial. On April 27, 2021, the company reported the earlier Phase I study not only met its primary endpoint of safety and tolerability, but top-line results also showed that Ampion reduced all-cause mortality in COVID-19 respiratory distress by 78 per cent over the Standard of Care (SOC) for patients suffering from respiratory distress due to COVID-19. Specifically, mortality in the SOC group was 24 per cent, while in the group treated with SOC and Ampion, mortality was only 5 per cent. ]]> <![CDATA[LifeCell raises Rs 255 Cr from OrbiMed Asia Partners IV]]> https://biospectrumindia.com/news/95/19601/lifecell-raises-rs-255-cr-from-orbimed-asia-partners-iv.html https://biospectrumindia.com/news/95/19601/lifecell-raises-rs-255-cr-from-orbimed-asia-partners-iv.html Tue, 21 Sep 2021 15:40:00 +0530 Established in Chennai, LifeCell International has raised Rs 225 crore from OrbiMed Asia Partners IV, a leading healthcare investment firm. As part of this round, the existing founders of LifeCell shall also participate by investing Rs 30 crore.     Mayur Abhaya, MD, LifeCell International, noted, "The funds will help accelerate this agenda and further strengthen our market position."   Dr Sunny Sharma, Senior MD, OrbiMed Asia, will join the Board of LifeCell upon the closure of this transaction. Dr Sharma said, “LifeCell has built a trusted healthcare brand in maternal and newborn health through innovation and service. We are very excited to partner with Mayur and his team in the next stage of LifeCell’s growth."   Ernst & Young acted as the investment banking advisor to LifeCell and LKS acted as the legal advisor.   ]]> <![CDATA[Lincoln Pharma earmarks Rs 30 Cr for facility expansion in Mehsana]]> https://biospectrumindia.com/news/95/19600/lincoln-pharma-earmarks-rs-30-cr-for-facility-expansion-in-mehsana.html https://biospectrumindia.com/news/95/19600/lincoln-pharma-earmarks-rs-30-cr-for-facility-expansion-in-mehsana.html Tue, 21 Sep 2021 13:15:00 +0530 Lincoln Pharmaceuticals plans to launch Cephalosporin products and the company has acquired a facility in Mehsana, Gujarat. There are plans to invest Rs 30 crore in the Cephalosporin plant including capacity expansion and modernisation of the facility and commercial operations is likely to start from March 2022. The plant is expected to contribute sales of around Rs 150 crore in the next three years and will cater to all the Cephalosporin products i.e. tablet, capsule, dry syrup and injectable. The company is in the process of applying for WHO GMP Certifications for the facility and expects to receive the same by December 2021 and plans to manufacture 20 plus Cephalosporin products. Cephalosporin is a bactericidal, broad-spectrum, and β-lactam antibiotic originally derived from the fungus Acremonium, which is used to treat bacterial infections such as pneumonia, skin infections, ear infection, strep throat, staph infections, tonsillitis, bronchitis and others.Mahendra Patel, MD, Lincoln Pharmaceuticals, said, "The entire expansion for Cephalosporin products will be funded from internal accruals."Lincoln Pharma plans to manufacture 20 plus Cephalosporin products including Cefalexin Oral Suspension BP, Clavulanate Tablets, Cefixime Capsules, Cefuroxime Axetil Tablets among others. The company also looks to export in African, Latin America and Southeast Asia markets and expand to other markets after necessary approvals. ]]> <![CDATA[Glenmark receives ANDA approval for Clindamycin Phosphate Foam]]> https://biospectrumindia.com/news/95/19598/glenmark-receives-anda-approval-for-clindamycin-phosphate-foam.html https://biospectrumindia.com/news/95/19598/glenmark-receives-anda-approval-for-clindamycin-phosphate-foam.html Tue, 21 Sep 2021 09:30:00 +0530 Glenmark Pharmaceuticals has received final approval by the United States Food & Drug Administration (US FDA) for Clindamycin Phosphate Foam, 1 per cent, the generic version of Evoclin 1 Foam, 1 per cent, of Mylan Pharmaceuticals Inc. The medication is used to treat acne.According to IQVIATM sales data for the 12 months ending July 2021, the Evoclin Foam, 1 per cent, market achieved annual sales of approximately $12.0 million.Glenmark’s current portfolio consists of 173 products authorised for distribution in the US marketplace and 47 ANDA’s pending approval with the US FDA. In addition to these internal filings, Glenmark continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio. ]]> <![CDATA[Zydus to sell two brands to Integrace]]> https://biospectrumindia.com/news/95/19595/zydus-to-sell-two-brands-to-integrace.html https://biospectrumindia.com/news/95/19595/zydus-to-sell-two-brands-to-integrace.html Mon, 20 Sep 2021 18:15:00 +0530 Zydus Healthcare, a wholly-owned subsidiary of the company has entered into an agreement with Integrace (“Purchaser”) to sell two brands viz. Mifegest and Cytolog. The said transaction is expected to be completed within 30 days from the date of execution of the agreement subject to customary approvals.Purchaser is a part of the portfolio companies of PE firm True North. The said transaction is not a related party transaction.Mifegest is an anti-progestational steroid class of drug used for medical termination of pregnancy. Cytolog tablet is a medicine used for medical abortion. ]]> <![CDATA[Cadila Pharma's Sepsivac gets nod from Philippines FDA for covid treatment]]> https://biospectrumindia.com/news/95/19581/cadila-pharmas-sepsivac-gets-nod-from-philippines-fda-for-covid-treatment.html https://biospectrumindia.com/news/95/19581/cadila-pharmas-sepsivac-gets-nod-from-philippines-fda-for-covid-treatment.html Sat, 18 Sep 2021 10:20:00 +0530 Cadila Pharmaceuticals' Sepsivac recently received its first overseas approval in the Philippines. Philippines FDA, looking into efficacy and safety of the product in covid treatment, allowed special importation of the Sepsivac on compassionate grounds, which shall strengthen the fight against covid.   Cadila marketing and formulations teams coordinated with authorities to arrange multiple webinars. KOLs from India shared their clinical experience of Sepsivac with Philippines HCPs. The Cadila Pharmaceuticals team worked under the guidance of Dr Bakulesh Khamar, Executive Director – Research & Development, Dr Manjul Joshipura, Senior Vice President, Innovations and New Products, and Mahidhwaj Sisodia, EVP- International Formulations Business, which paved way for the first overseas approval of Sepsivac.       ]]> <![CDATA[CII Gujarat highlights pharma reforms ushered in by COVID-19]]> https://biospectrumindia.com/news/95/19577/cii-gujarat-highlights-pharma-reforms-ushered-in-by-covid-19.html https://biospectrumindia.com/news/95/19577/cii-gujarat-highlights-pharma-reforms-ushered-in-by-covid-19.html Fri, 17 Sep 2021 12:30:00 +0530 CII Gujarat region and Dholera Industrial City, Government of Gujarat hosted a virtual conference on pharma and biotechnology that brought together key speakers from the government and industry who shared insights on the changing landscape of pharma and biotechnology sectors in COVID-19 times and beyond.   The focus areas of the conference ‘Future of Pharma & Biotechnology: Sustaining Innovation beyond Pandemic’ included the future of vaccines, R&D challenges, Pharma 4.0 in biotechnology, robotics, digitalisation and validation, and reshaping pharma for a new era.   Anand Desai, Vice Chairman, CII Gujarat region, said, “The changes the pandemic has ushered in will outlast the pandemic. Gujarat is the hub of pharma manufacturers in India and is poised to strengthen its position further.”   Addressing the conference, Dr K Bangarurajan, Advisor, Central Drugs Standard Control Organization (CDSCO) spoke about the reforms undertaken by the government during the pandemic. “The government is committed to supporting the pharma industry. The reforms undertaken before and during the pandemic will continue. The pharma industry also needs to shift its focus on research and development of innovative products and services,” he said.     Sudhir Vaid, CMD, Concord Biotech, stressed the need for the Indian pharma industry to keep pace with technology. “Many large Indian pharma companies that were doing well in the 1980s do not even exist now because they did not adopt new technologies. It is critical to adopt the latest technologies to boost research and manufacturing capabilities,” he said.   Biswajit Mitra, Chief Mentoring Officer, Cadila Pharmaceuticals, said focus therapies, building strong partnerships, first-time generics in India, vaccines, and biosimilars as the growth drivers for the Indian pharma industry post-pandemic.     ]]> <![CDATA[NCLT approves amalgamation scheme of Lincoln Parenteral and Lincoln Pharma]]> https://biospectrumindia.com/news/95/19573/nclt-approves-amalgamation-scheme-of-lincoln-parenteral-and-lincoln-pharma.html https://biospectrumindia.com/news/95/19573/nclt-approves-amalgamation-scheme-of-lincoln-parenteral-and-lincoln-pharma.html Thu, 16 Sep 2021 19:35:00 +0530 National Company Law Tribunal, Ahmedabad Bench, (NCLT) has approved the scheme of amalgamation of Lincoln Parenteral and Lincoln Pharmaceuticals under Sections 230 to 232 and other applicable provisions of the Companies Act, 2013. Amalgamation is expected to bring a lot of synergies in terms of operations efficiency, enhance competitive strength, cost-effectiveness and productivity for the combined entity.    The order sanctioning the scheme was pronounced on September 14, 2021, and uploaded on the website of NCLT on September 15, 2021. The appointed date of the scheme is April 01, 2019. The scheme will be effective upon the filing of the certified copy of the order of the NCLT with the Registrar of Companies, Gujarat. Lincoln Parenteral Ltd is a subsidiary company of Lincoln Pharmaceuticals engaged in the business of small Parenteral Injection Products.    Mahendra Patel, MD, Lincoln Pharmaceuticals, said, "The corporate restructuring practice will bring a lot of synergies for both the company and will lead to increased competitive strength, cost reduction and efficiencies, productivity gains, and logistic advantages, thereby significantly contributing to future growth. We are confident to improve our growing numbers of revenue, margins and profitability in FY22. Our strategic growth initiatives, product and geographical expansion, operational efficiency and debt-free status are likely to maximise value for all stakeholders in the near to medium term."   ]]> <![CDATA[Glenmark concludes largest post marketing study on FabiFlu in 1000+ COVID-19 patients]]> https://biospectrumindia.com/news/95/19562/glenmark-concludes-largest-post-marketing-study-on-fabiflu-in-1000-covid-19-patients.html https://biospectrumindia.com/news/95/19562/glenmark-concludes-largest-post-marketing-study-on-fabiflu-in-1000-covid-19-patients.html Wed, 15 Sep 2021 18:05:00 +0530 Glenmark Pharmaceuticals has announced the successful completion of its Post Marketing Surveillance (PMS) study on Favipiravir (FabiFlu) in India. The PMS study commenced in July 2020 to evaluate the safety and efficacy of Favipiravir in mild to moderate COVID-19 patients.   A total of 1083 patients were enrolled in the prospective, open-label, multicentre, single-arm study. Results showed no new safety signals or concerns with the use of Favipiravir, and already-known side effects such as weakness, gastritis, diarrhoea, vomiting etc., were found to be mild. The time for fever resolution was four days, while the time for the clinical cure was seven days.   Glenmark's PMS study is the first and largest post-marketing study conducted in India on Favipiravir in mild to moderate COVID-19 patients. 13 sites - both government and private institutions - across Mumbai, Bengaluru, Hyderabad, Nashik, Nagpur, and Tiruvananthapuram took part. The study was conducted in patients in line with the approved indication of the drug.   Alok Malik, Group VP & Head, India Formulations, said, "This study was crucial as it examined the safety and efficacy of FabiFlu in real-world settings, where multiple variables can impact the results. Despite these factors, the PMS study demonstrated FabiFlu's consistent ability to provide symptomatic relief and improve clinical outcomes in patients with mild to moderate COVID-19. It is a step forward both for Glenmark and the medical community, as it reinforces the oral antiviral's multiple benefits in tackling the pandemic." ]]> <![CDATA[Laurus Labs, Unitaid, CHAI to accelerate development of HIV medication for children]]> https://biospectrumindia.com/news/95/19561/laurus-labs-unitaid-chai-to-accelerate-development-of-hiv-medication-for-children.html https://biospectrumindia.com/news/95/19561/laurus-labs-unitaid-chai-to-accelerate-development-of-hiv-medication-for-children.html Wed, 15 Sep 2021 17:55:00 +0530 Hyderabad-based Laurus Labs has announced that the development is underway to accelerate the commercialisation and registration of the best-in-class second-and third-line HIV treatment darunavir boosted with ritonavir (DRV/r) for children. An agreement was launched between Laurus Labs, Unitaid and the Clinton Health Access Initiative (CHAI) in June 2021.Through this agreement, Unitaid and CHAI are working with Laurus Labs to finally address the critical need and ensure CLHIV (Children Living with HIV/AIDS) have access to high-quality second-and third-line HIV treatment.Second- and third-line therapies are critical for CLHIV where the World Health Organization (WHO)-recommended first-line treatment dolutegravir (DTG) may not be an option due to medication resistance or intolerance. Currently, available second-and third-line treatments are often difficult for children to take due to bitter taste and difficult forms of administration.   “A paediatric version of DRV/r has been a global health priority since 2013, but is still not available, leaving thousands of children without the lifesaving medication they need,” said Ann Veneman, interim Co-CEO, CHAI. “The innovative incentive programme will enable the development of an effective paediatric medication that will save the lives of children living with HIV.”  Dr Satyanarayana Chava, Founder & CEO, Laurus Labs, said, “We are excited about this innovative mechanism to accelerate the availability of pDRV/r regimen for children living with HIV. The collaboration between Laurus Labs, CHAI, and Unitaid can positively impact over 100,000 CLHIVs and help them in leading a better life especially in their formative years.” ]]> <![CDATA[BDR Pharma announces launch of generic cancer drug Cabozantinib]]> https://biospectrumindia.com/news/95/19557/bdr-pharma-announces-launch-of-generic-cancer-drug-cabozantinib.html https://biospectrumindia.com/news/95/19557/bdr-pharma-announces-launch-of-generic-cancer-drug-cabozantinib.html Tue, 14 Sep 2021 16:05:00 +0530 Mumbai-based BDR Pharma has launched CABOZANTINIB to treat metastatic medullary thyroid cancer, advanced renal cell carcinoma and hepatocellular carcinoma. BDR Pharma is amongst the first to receive permission from DCGI and launch the drug in India, which will be available in the market in the next few days.The drug works by blocking (inhibiting) the signals inside cancer cells that make them grow and divide. In several trials like Celestial (double-blind phase III trial), Phase III Meteor trials, CABOZANIB is shown to have a better PFS (Progression-Free Survival).   Raheel Shah, Director – Business Development, BDR Pharmaceuticals, expressed: "Though we have been outstretched in all departments to deliver on Covid treatment on an emergency basis, we have not allowed this to hamper our efforts on other equally important priority segments, including oncology. We have ensured that all the other equally important segments, especially oncology, receive their priority tag, and all necessary allocations have been made accordingly. The result is the advent development of this new generic cancer molecule called "Cabozantinib (Cabozanib)." ]]> <![CDATA[Godrej partners with DRDO to manufacture oxygen generators ]]> https://biospectrumindia.com/news/95/19555/godrej-partners-with-drdo-to-manufacture-oxygen-generators-.html https://biospectrumindia.com/news/95/19555/godrej-partners-with-drdo-to-manufacture-oxygen-generators-.html Tue, 14 Sep 2021 14:55:00 +0530 Godrej & Boyce, the flagship company of the Godrej Group, has announced that one of its businesses, Godrej Precision Engineering has received an order from the Defence Bio-engineering and Electromechanical Laboratory, (DEBEL), a Defence Research and Development Organisation (DRDO) laboratory in Bengaluru to manufacture oxygen generators to support India’s oxygen buffer plan.   DRDO has transferred the technology from the existing technology partner to 10 private sector companies including Godrej & Boyce.    The first batch has been manufactured and supplied to rural hospitals across Uttar Pradesh, Uttarakhand and Madhya Pradesh within a record period of one month.   The system utilises an air compressor to provide compressed air to the oxygen plant which is filtered and dried by a refrigerant air dryer and further filtered before the air is admitted to the oxygen generator through adsorption towers.   The oxygen generator removes the nitrogen from the air by absorbing it in the molecular sieves and produces an output with 93±3 per cent oxygen. For separating oxygen from the air, the medical oxygen generator employs the Pressure Swing Adsorption (PSA) technique. The output is stored in a storage tank. Each generator can produce 250 litres of oxygen per minute which can cater to 50 patients.      ]]> <![CDATA[PharmEasy to launch development centres in Hyderabad, Pune and NCR]]> https://biospectrumindia.com/news/95/19551/pharmeasy-to-launch-development-centres-in-hyderabad-pune-and-ncr.html https://biospectrumindia.com/news/95/19551/pharmeasy-to-launch-development-centres-in-hyderabad-pune-and-ncr.html Mon, 13 Sep 2021 18:40:00 +0530 PharmEasy is now looking to hire 200+ engineering talent for its soon-to-be-launched development centres in Hyderabad, Pune and NCR region. PharmEasy is planning to strengthen its hiring across technological functions.PharmEasy currently stands strong with 6100+ employees.   Abhinav Yajurvedi, CTO, PharmEasy, says, “The new facilities will serve as a significant hub for driving development and innovation. Ahead of the opening of the new centres, PharmEasy will provide opportunities for inquisitive technology professionals across product and engineering, in different locations from all over the country, with a flexible work model. The centres will begin their operations with a team of experienced leaders who will be at the forefront of the growth charters. The development centres will be available in hybrid and flexible working environments, operating out of shared working spaces for hiring tech talent."       ]]> <![CDATA[Menarini India introduces Definisse double-needle threads]]> https://biospectrumindia.com/news/95/19549/menarini-india-introduces-definisse-double-needle-threads.html https://biospectrumindia.com/news/95/19549/menarini-india-introduces-definisse-double-needle-threads.html Mon, 13 Sep 2021 16:30:00 +0530 Biopharmaceutical company Menarini, and its dermatology and aesthetic medicine arm RELIFE have introduced Definisse double needle threads in India. The threads require reduced procedural and recovery time, no general anaesthesia with immediate and visible results leading to higher patient satisfaction. The aesthetic procedure using Definisse double-needle threads results in contouring, lifting, realignment of sagging tissue, and reinforcement of the middle and lower thirds of the face and neck.    The aesthetic medicine solution is used for supporting and repositioning soft tissue for the cheek, jawline, and eyebrow. When placed under the skin, the barbs open like an umbrella to form a support structure that lifts the sagging skin.    Definisse threads are made of copolymers of synthetic origin poly(L-lactide-co-ε-caprolactone). The threads were designed to have a barbed tri-dimensional geometry to enable them to maintain a mechanical lifting action for repositioning of sagging facial tissue, and a histological revitalizing action from the stimulation of fibroblasts and the synthesis of collagen, hyaluronic acid and elastin around the threads. The threads can be used to perform three-dimensional tissue repositioning and to provide a noticeable lifting effect for mild to moderate sagging tissue, with results last over 18 months as shown in clinical studies due to the collagen-stimulating properties. ]]> <![CDATA[DTDC, Narayana Health set up oxygen generator plant in Jaipur]]> https://biospectrumindia.com/news/95/19548/dtdc-narayana-health-set-up-oxygen-generator-plant-in-jaipur.html https://biospectrumindia.com/news/95/19548/dtdc-narayana-health-set-up-oxygen-generator-plant-in-jaipur.html Mon, 13 Sep 2021 16:05:00 +0530 DTDC and its strategic partner, Geopost SA (DPD Group), owned by France’s Le Groupe La Poste, have associated with Narayana Hrudayalaya Charitable Trust and Narayana Hrudayalaya for the successful set-up and inauguration of an oxygen generator plant in Jaipur. The one-of-its-kind oxygen generator plant was inaugurated by DTDC CMD Subhasish Chakraborty, in the presence of top officials from DTDC and Narayana Health. The valuable joint -initiative, installed in the Narayana multi-speciality hospital in Jaipur, is geared to help the country fight the ongoing Covid pandemic. The plant can generate medical-grade oxygen at 500 litres a minute.Chakraborty said, “The cutting-edge oxygen generator plant, imported from the US, is a result of joint efforts of DTDC, our strategic partner, Geopost SA (DPD Group) and the able team at Narayana Health. As a part of our CSR program for covid care support, we have made a significant contribution of Rs 1.56 crore to Narayana Hrudayalaya Charitable Trust. DTDC and Geopost SA (DPD Group) also ensured the seamless logistical movement of the oxygen generator plant."Arunesh Punetha, Regional director, Narayana Health said, “We are confident that with DTDC Express as our partners, we will be able to touch & positively impact thousands of lives together. Both the organisations will continue to support the people of Jaipur & Rajasthan in tiding over these challenging times”. ]]> <![CDATA[ICPA launches saliva substitute for dry mouth condition]]> https://biospectrumindia.com/news/95/19547/icpa-launches-saliva-substitute-for-dry-mouth-condition.html https://biospectrumindia.com/news/95/19547/icpa-launches-saliva-substitute-for-dry-mouth-condition.html Mon, 13 Sep 2021 15:55:00 +0530 ICPA Health Products (ICPA) has launched Wet Mouth, a saliva substitute for treating individuals suffering from xerostomia or commonly known as dry mouth. A dry mouth occurs when the salivary glands are not able to produce enough saliva to keep the mouth wet.    ICPA's Wet Mouth contains Sodium Carboxymethyl Cellulose in a pleasantly flavoured base that helps enhance oral lubrication in the mouth and is an easy solution to overcome a dry mouth. Regular use of wet mouth keeps the oral mucosa moist and lubricated. It reduces surface abrasion which helps patients eat, swallow and speak comfortably. Every 5 ml of Wet Mouth contains Sodium Carboxymethyl cellulose 0.5 per cent w/v, Glycerine 30 per cent w/v.   ]]> <![CDATA[CORE Diagnostics opens two new labs in Delhi and Bengaluru]]> https://biospectrumindia.com/news/95/19532/core-diagnostics-opens-two-new-labs-in-delhi-and-bengaluru.html https://biospectrumindia.com/news/95/19532/core-diagnostics-opens-two-new-labs-in-delhi-and-bengaluru.html Thu, 09 Sep 2021 17:10:00 +0530 CORE Diagnostics has announced the launch of two new labs in Delhi and Bengaluru. The Delhi lab in Green Park is fully operational and has been accepting samples across Delhi NCR, and the second diagnostic lab in Richmond Circle, Bengaluru has just started operations.   The new facilities will provide a wide range of tests starting from health packages to launching reproductive testing to high-end molecular testing. Within a year, the company plans to pick up samples from over 300 cities across India and with deeper global expansion planned across Asia, the Middle East and Africa.    In addition to these owned and operated labs, CORE is also expanding through partnerships. They recently partnered with GJ Diagnostics Lab in Ludhiana to expand their presence across Punjab and with the Institute of Liver and Biliary Sciences, New Delhi on Next Generation Sequencing (NGS) testing.    The Bengaluru lab is the first major investment in South India and will also serve as a digital pathology hub. All samples collected will be scanned, and examined by the pathologists in CORE’s Gurgaon lab and referred to our global panel of organ specialists if necessary.    ]]> <![CDATA[SIRO Clinpharm, JRF to offer end-to-end drug development solution]]> https://biospectrumindia.com/news/95/19523/siro-clinpharm-jrf-to-offer-end-to-end-drug-development-solution.html https://biospectrumindia.com/news/95/19523/siro-clinpharm-jrf-to-offer-end-to-end-drug-development-solution.html Wed, 08 Sep 2021 13:15:00 +0530 Mumbai-based clinical research organisation SIRO Clinpharm has announced an agreement with Jai Research Foundation (JRF), a Vapi-based contract research organisation, with an expansive portfolio of non-clinical regulatory research services to provide pre-clinical offerings.   With this second strategic partnership, SIRO has now expanded its offering portfolio by providing end-to-end services. Last year in June 2020, the company had announced its first strategic partnership with Azidus to expand combined services offerings and avail access to an expanded client base for technical requisites of pharma and biotech industries.   Commenting on the agreement, Akshay Daftary, Director, SIRO Clinpharm said, “The agreement would boost SIRO’s presence across geographies like Japan, the EU, LatAm countries, Canada, and the US.”   “With this agreement, both the companies stand to benefit, with their pooled mutual scientific talent and their capabilities to offer comprehensive solutions to their mutual sponsors,” said Dr Sameer Navalgund, Director, JRF-Global.     ]]> <![CDATA[Metropolis opens 1,200 sq ft testing centre in Latur]]> https://biospectrumindia.com/news/95/19522/metropolis-opens-1200-sq-ft-testing-centre-in-latur.html https://biospectrumindia.com/news/95/19522/metropolis-opens-1200-sq-ft-testing-centre-in-latur.html Wed, 08 Sep 2021 13:10:00 +0530 Metropolis Healthcare has launched a new centre in Latur, Maharashtra. The 1,200 sq ft laboratory can conduct more than 20,000 sample testing per month with a quick turnaround time and high-quality reports. The inauguration was done by Latur City Mayor Vikrant Gojamgunde.   Metropolis Laboratory, Latur, will offer about 4000 + clinical laboratory tests and profiles, which are used for prediction, early detection, diagnostic screening, confirmation and/or monitoring of the disease.   The new lab is located at Raviraj Chambers, Shop - 9, Near Mahanagar Palika Office, Latur, Maharashtra. ]]> <![CDATA[Dr Reddy’s launches drug for female pattern hair loss]]> https://biospectrumindia.com/news/95/19518/dr-reddys-launches-drug-for-female-pattern-hair-loss.html https://biospectrumindia.com/news/95/19518/dr-reddys-launches-drug-for-female-pattern-hair-loss.html Tue, 07 Sep 2021 14:20:00 +0530 Hyderabad-based Dr Reddy’s Laboratories has launched the prescription drug Minoxidil topical solution  USP  2 per cent and 5 per cent for the treatment of female pattern hair loss (FPHL). Dr Reddy’s will sell its products under the brand names Mintop 2 per cent and Mintop Eva 5 per cent respectively.  The launch follows the first-ever approval of the additional indication by the Central Drugs Standard Control Organization (CDSCO)  in  India for the use of  Minoxidil topical solution USP 2 per cent and 5 per cent for treatment of FPHL. Minoxidil topical solution will become available as a first-line treatment option for FPHL in India. While Minoxidil topical solution has been approved in India for the treatment of alopecia in men (male pattern baldness), there are presently no other drugs approved for the treatment of FPHL in India. MV Ramana, CEO, Branded Markets (India & Emerging Markets) Dr Reddy’s Laboratories said, “This approval marks the first-ever given to a first-line treatment option for female pattern hair loss, and truly fulfils a hitherto unmet need. Our Minoxidil topical solution (Mintop 2 per cent and Mintop Eva 5 per cent) for women will be widely available in the country, and through this launch, we hope to bring relief and comfort to patients diagnosed with FPHL in India.” ]]> <![CDATA[Panacea Biotec ships second component of Sputnik V vaccine ]]> https://biospectrumindia.com/news/95/19516/panacea-biotec-ships-second-component-of-sputnik-v-vaccine-.html https://biospectrumindia.com/news/95/19516/panacea-biotec-ships-second-component-of-sputnik-v-vaccine-.html Tue, 07 Sep 2021 11:30:00 +0530 The Russian Direct Investment Fund (RDIF, Russia’s sovereign wealth fund) and New Delhi-based Panacea Biotec have announced the supply of the first shipment out of 1 million doses of the second component (human adenovirus serotype 5) of the Russian Sputnik V coronavirus vaccine manufactured by Panacea Biotec for sale in India. This is the first batch of the second component produced and supplied by the Panacea Biotec in India. Doses of the second component of Sputnik V have been manufactured at Panacea Biotec’s manufacturing facility in Himachal Pradesh. The company received the necessary clearance from Central Drug Laboratories (CDL), Kasauli recently. Full-scale production of Sputnik V started at Panacea Biotec’s facilities this summer. Facilities comply with GMP standards and are prequalified by WHO. The batch will be distributed in India through a partner of RDIF and Panacea Biotec – Dr Reddy’s Laboratories. To date, Sputnik V has been authorized in 70 countries with a total population of over 4 billion people.Dr Rajesh Jain, MD, Panacea Biotec, said, “Panacea Biotec is pleased to have successfully produced and dispatched the first batch of Component II (Ad5) of Sputnik V vaccine. More batches are currently under production at our manufacturing facility in Himachal Pradesh.” ]]> <![CDATA[Dr Reddy’s sells rights of anti-cancer agent E7777 to Citius Pharma]]> https://biospectrumindia.com/news/95/19513/dr-reddys-sells-rights-of-anti-cancer-agent-e7777-to-citius-pharma.html https://biospectrumindia.com/news/95/19513/dr-reddys-sells-rights-of-anti-cancer-agent-e7777-to-citius-pharma.html Mon, 06 Sep 2021 15:35:00 +0530 Dr Reddy’s Laboratories has entered into a definitive agreement with Citius Pharmaceuticals, Inc (Citius) under which it sold all of its rights to E7777 (an engineered IL-2-diphtheria toxin fusion protein) and certain related assets.   Under the terms of the agreement, Dr Reddy’s will receive $40 million upfront upon the closing of the transaction, followed by approval milestone payment of up to $40 million related to the CTCL (cutaneous T-cell lymphoma) indication approval and up to $70 million for additional indication approvals. Further, Dr Reddy’s will receive certain sales-based milestones and tiered earn-out payments.   Erez Israeli, CEO, Dr Reddy’s, said: “Addressing unmet patient needs in oncology remains a prime focus area for us. E7777 has significant potential as an important component of systemic therapy for CTCL and other cancers. Post acquiring from Eisai, significant progress was made on the CTCL development front. We are confident of Citius’ ability to realize the full potential of E7777 in the treatment of CTCL as well as in their ability to develop this promising drug for additional oncology and immuno-oncology indications.”   ]]> <![CDATA[TB Alliance, Lupin partner for drug-resistant TB drug]]> https://biospectrumindia.com/news/95/19509/tb-alliance-lupin-partner-for-drug-resistant-tb-drug.html https://biospectrumindia.com/news/95/19509/tb-alliance-lupin-partner-for-drug-resistant-tb-drug.html Mon, 06 Sep 2021 11:15:00 +0530 Non-profit drug developer, TB Alliance has granted Lupin, a non-exclusive license to manufacture the anti-TB drug pretomanid as part of the three-drug 'BPaL' regimen. Lupin intends to commercialise the anti-tuberculosis (TB) medicine in approximately 140 countries and territories, including many of the highest TB burden countries around the world.   “TB Alliance is committed to ensuring its products are widely available and affordable to those who need them,” said Mel Spigelman, President and CEO, TB Alliance. “Partnering with Lupin, a well-established manufacturer with experience delivering high-quality TB therapies, will help further enable widespread access to our novel regimen while promoting a competitive market to drive affordability.”   Nilesh Gupta, MD, Lupin added, “As a global leader in anti-TB medicines, Lupin is committed to enhancing access to bridge unmet needs in countries where it is needed the most. This collaboration with TB Alliance leverages our strength and expertise to contribute to better global health.”   “Tuberculosis is one of humanity’s oldest, deadliest, and most persistent diseases. Lupin is the largest supplier of first-line anti-TB drugs in the world, and we are excited to partner with TB Alliance to help bring new therapies for highly drug-resistant TB to reach individuals and countries where access to these medicines is so urgently needed,” said Naresh Gupta, President API Plus, Lupin. ]]> <![CDATA[Biological E's CORBEVAX bags DCGI approval for Ph III trials]]> https://biospectrumindia.com/news/95/19499/biological-es-corbevax-bags-dcgi-approval-for-ph-iii-trials.html https://biospectrumindia.com/news/95/19499/biological-es-corbevax-bags-dcgi-approval-for-ph-iii-trials.html Fri, 03 Sep 2021 15:00:00 +0530 Hyderabad-based Biological E has received Drugs Controller General of India (DCGI) approval for conducting Phase III Comparator Safety & Immunogenicity trial in adults after Subject Expert Committee’s (SEC) review of Phase I and II clinical trials data.   Additionally, Biological E also received approval on 01.09.2021 to initiate the Phase II/III study to evaluate the safety, reactogenicity, tolerability and immunogenicity of the CORBEVAX vaccine in children and adolescents. The candidate is an receptor binding domain (RBD) protein subunit vaccine.   The Department of Biotechnology (DBT) and its PSU, Biotechnology Industry Research Assistance Council (BIRAC) have supported Biological E’s COVID-19 Vaccine candidate from Preclinical Stage to Phase III clinical studies.   In addition to receiving financial assistance under Mission COVID Suraksha, this vaccine candidate has also obtained a financial support under COVID-19 Research Consortia through National Biopharma Mission, BIRAC. ]]> <![CDATA[Morepen Labs board approves PoC medical devices biz into wholly-owned subsidiary]]> https://biospectrumindia.com/news/95/19490/morepen-labs-board-approves-poc-medical-devices-biz-into-wholly-owned-subsidiary.html https://biospectrumindia.com/news/95/19490/morepen-labs-board-approves-poc-medical-devices-biz-into-wholly-owned-subsidiary.html Thu, 02 Sep 2021 12:25:00 +0530 New Delhi-based Morepen Labs plans to carve out the business into a separate wholly-owned subsidiary both for building teams to manage the scale of operations of large and fast-growing businesses and unique features of point-of-care (PoC) business.   It also plans to bring in fresh capital that makes it imperative to have a separate subsidiary to undertake this fast-expanding PoC business.   The proposed segregation will give clarity to the working teams, trade customers and other stakeholders. Post this spin-off, the company will be able to put the entire focus on its core business of active pharmaceutical ingredients (API) and formulations.    After hiving off medical devices business into a wholly-owned subsidiary company, separate dedicated management will work for the development of Medical Devices Business in a separate independent entity.   In the second phase post hive off, the medical devices company would go for CE Certification of its manufacturing facilities to become the hub for PoC manufacturing in India.   The new entity plans to deploy more resources on the R&D, backwards integration of core technologies like making enzymes /proteins and develop a data lab for connected devices.   ]]> <![CDATA[Metropolis opens centre in Thalassery, Kerala]]> https://biospectrumindia.com/news/95/19486/metropolis-opens-centre-in-thalassery-kerala.html https://biospectrumindia.com/news/95/19486/metropolis-opens-centre-in-thalassery-kerala.html Wed, 01 Sep 2021 17:40:00 +0530 Metropolis Healthcare has launched a new centre in Thalassery, Kerala. The 1,600 sq ft laboratory can conduct more than 60,000 sample testing per month with a quick turnaround time and high-quality reports.    Metropolis Laboratory, Thalassery will offer about 4,000 different tests ranging from basic day to day pathology tests to high-end molecular diagnostics tests. Metropolis Healthcare has its laboratories located in Kangahad, Mattannur, Dharamshala, Pazhayangadi, Calicut and Kannur.   Dr Ramesh Kumar, Chief of Laboratory, Metropolis Kerala said, “We sincerely hope that we can reach out to and help those who are finding it difficult to cope with the burden of the illnesses around in the state of Kerala.” ]]> <![CDATA[Healthium buys CareNow to strengthen portfolio of patented products]]> https://biospectrumindia.com/news/95/19480/healthium-buys-carenow-to-strengthen-portfolio-of-patented-products.html https://biospectrumindia.com/news/95/19480/healthium-buys-carenow-to-strengthen-portfolio-of-patented-products.html Wed, 01 Sep 2021 10:55:00 +0530 Bengaluru-based medtech firm Healthium has announced the successful acquisition of CareNow Medical, strengthening its product portfolio with patented and differentiated products in the advanced wound management and infection prevention segments.    This is the third acquisition by Healthium in the calendar year 2021. Earlier this year, Healthium had acquired the AbGel business in India and VitalCare in the UK to expand its surgical and post-surgical care portfolio.   Healthium’s product portfolio covers surgical consumables, urology and arthroscopy products. Its manufacturing facility at Bengaluru is registered with the US FDA.   With this acquisition, Healthium strengthens its portfolio of patented products through the addition of CareNow’s advanced wound dressing which has patents across the US, Europe and India.   Further, the acquisition adds to Healthium’s manufacturing and R&D capabilities. CareNow’s manufacturing facility in Coimbatore is US FDA registered and will count as the 8th manufacturing facility for Healthium.      ]]> <![CDATA[Anupam Rasayan signs LOI with Japanese firm for Rs 135 Cr ]]> https://biospectrumindia.com/news/95/19472/anupam-rasayan-signs-loi-with-japanese-firm-for-rs-135-cr-.html https://biospectrumindia.com/news/95/19472/anupam-rasayan-signs-loi-with-japanese-firm-for-rs-135-cr-.html Tue, 31 Aug 2021 12:05:00 +0530 Surat-based Anupam Rasayan has received and signed a letter of intent (LOI) amounting to Rs 135 crore with a Japanese multinational chemical company for supplying a life sciences related speciality chemical product. The company will enter into a long-term contract with the Japanese multinational firm for the next four years to supply this life science-related speciality chemical product.   Speaking about the order, Anand Desai, MD, Anupam Rasayan, said, “This order will further strengthen our revenue and profitability visibility and also showcases the quality of the product allowing the customer to depend upon the company on a long-term basis making Anupam Rasayan, a preferred partner for these MNCs.”  The speciality chemicals major is manufacturing products for over 66 domestic and international customers, including 24 multinational companies. The company has a long history of high customer retention and have been manufacturing products for select customers for over a decade. The company caters to a diverse base of Indian and global customers. ]]> <![CDATA[Health Minister launches first commercial batch of COVAXIN manufactured in Ankleshwar]]> https://biospectrumindia.com/news/95/19453/health-minister-launches-first-commercial-batch-of-covaxin-manufactured-in-ankleshwar.html https://biospectrumindia.com/news/95/19453/health-minister-launches-first-commercial-batch-of-covaxin-manufactured-in-ankleshwar.html Sun, 29 Aug 2021 08:00:00 +0530 Hyderabad-based Bharat Biotech has announced the commercial launch of the first batch of COVAXIN® from its Chiron Behring Vaccines facility in Ankleshwar, Gujarat.  Union Health Minister Mansukh Mandaviya inaugurated the COVAXIN® batches.  Dr. Krishna Ella, Chairman & Managing Director, Bharat Biotech and Suchitra Ella, Joint Managing Director, Bharat Biotech were also present at the launch. The company has already deployed multiple production lines at its Hyderabad, Malur, Bengaluru, and Pune campuses, and the addition of Chiron Behring, Ankleshwar will further augment its COVAXIN® production capacity. A new filing facility constructed during 2020 is now being utilized for the production of COVAXIN®. The COVAXIN® production had begun in early June, before which the team had executed engineering batches to study the equipment functionality at the facility. Chiron Behring Vaccines is a wholly owned subsidiary of Bharat Biotech.  Dr. Krishna Ella, Chairman & Managing Director, Bharat Biotech, said, “Our goal to develop a vaccine with global safety and efficacy standards has now been achieved, we are now marching towards the goal of annualized capacity of ~ 1.0 billion doses.” ]]> <![CDATA[Equipment shortage, high API cost affects drug availability during Covid: Infomerics]]> https://biospectrumindia.com/news/95/19445/equipment-shortage-high-api-cost-affects-drug-availability-during-covid-infomerics.html https://biospectrumindia.com/news/95/19445/equipment-shortage-high-api-cost-affects-drug-availability-during-covid-infomerics.html Thu, 26 Aug 2021 21:40:00 +0530 Indian vaccine manufacturers face a crucial shortage of equipment including small- and large-scale bioreactors and fermenters, according to Infomerics report on Pharma Industry: Trends and Prospects. The report reveals that the steep 50 per cent rise in the cost of Active Pharmaceutical Ingredients (API) is pinching the industry hard and raises doubts on the availability of drugs and could lead to shortages, particularly of those that are key in COVID therapy.   While nearly 70 per cent of the country’s APIs are imported from China, the dependence rises to 90 per cent for certain life-saving antibiotics like cephalosporins, azithromycin and penicillin. Since these medicines are under price control, companies are forced to absorb the higher cost, raising questions about their viability. In this scenario, over time, certain medicines could disappear from retail shelves.   The report also highlights the gap in diagnostic services in India, particularly in rural India. This led to a scramble to urban areas for healthcare with attendant implications for loss of wages and the high cost of travel, testing and treatment. It makes a strong pitch for digital technology, which can be “a catalytic element of the transformation” of the healthcare scenario in India. The success stories in diverse parts of India, viz., Rajasthan, Arunachal Pradesh, Telangana, Kerala, Haryana, Andhra Pradesh, Bihar, Jharkhand, Uttarakhand, and Maharashtra need to be replicated at the wider national level to bring about a perceptible improvement in the rural healthcare system.   The report mention further states that given the state of the rural healthcare system in the country and the meagre expenditure on health earmarked in the Union Budget (the overall spending on health varied from 1.3 per cent of the GDP in 2010-11 to 1.5 per cent and 1.8 per cent of the GDP RE for 2019-20 and BE for 2020-21, respectively), there are strong and compelling reasons for enhancing the expenditure on the healthcare system in India.   The report highlights some catalytic initiatives of the government including the Production Linked Incentive (PLI) scheme for the promotion of domestic manufacturing of critical key starting materials (KSMs)/and Drug Intermediates and APIs, and the JanaushadhiPariyojana to make available quality medicines consumables and surgical items at affordable prices for all and reduce out of pocket expenditure of consumers/patients.   The report is optimistic about the future of the sector. Despite being wrecked by COVID, the pharma industry grew 37 per cent year-on-year and 15 per cent sequentially in Q1FY22. The growth was driven by sales of COVID treatment drugs and other drugs. “The cost of manufacturing in India is approximately 33 per cent lower than that of the US. Therefore, the industry can benefit from these attributes and accordingly scale up production, productivity and efficiency. But the realisation of this potential necessitates harnessing economies of scale to move to a newer and higher orbit.   It also recommended that the industry explore new and innovative options to generate and sustain new revenue streams. The increased demand for healthcare and insurance, for example, opens new avenues for investment, particularly in areas like chronic therapies for diseases such as cardiovascular, anti-diabetes, anti-depressants and anti-cancer treatment.   ]]> <![CDATA[Vijaya Diagnostic Centre IPO to open on Sept 1, 2021]]> https://biospectrumindia.com/news/95/19441/vijaya-diagnostic-centre-ipo-to-open-on-sept-1-2021.html https://biospectrumindia.com/news/95/19441/vijaya-diagnostic-centre-ipo-to-open-on-sept-1-2021.html Thu, 26 Aug 2021 15:15:00 +0530 Vijaya Diagnostic Centre proposes to open its Initial Public Offering on Wednesday, September 1, 2021. The price band of the offer has been fixed at Rs 522 to Rs 531 per equity share. Bids can be made for a minimum of 28 equity shares and in multiples of 28 equity shares thereafter. The offer will close on Friday, September 3, 2021. The Initial Public Offering consists of an offer for sale of up to 35,688,064 equity shares by the selling shareholders, consisting of up to 5,098,296 equity shares by Dr S Surendranath Reddy (Promoter Selling Shareholder), up to 29,487,290 equity shares by Karakoram and up to 1,102,478 equity shares by Kedaara Capital Alternative Investment Fund- Kedaara Capital AIF 1.The company expects that listing of the equity shares will enhance its visibility and brand image and provide liquidity to Shareholders and will also provide a public market for the equity shares in India. ICICI Securities, Edelweiss Financial Services and Kotak Mahindra Capital Company are the Book Running Lead Managers to the issue. ]]> <![CDATA[Merck donates Rs 1.7 Cr to IIT-B for COVID-19 research]]> https://biospectrumindia.com/news/95/19439/merck-donates-rs-1-7-cr-to-iit-b-for-covid-19-research.html https://biospectrumindia.com/news/95/19439/merck-donates-rs-1-7-cr-to-iit-b-for-covid-19-research.html Thu, 26 Aug 2021 13:30:00 +0530 Merck has announced a donation of Rs 1.7 crore over two years to the Indian Institute of Technology (IIT), Bombay to support the development of clinical tests for COVID-19 disease severity assessment.   The funded project is an ongoing COVID-19 multi-omics research on the development of simple immunoassays based on single-molecule counting technology to identify low levels of early disease severity markers.    Sunil Punjabi, MD, Life Science Business, Merck India said, "With this donation, Merck is aiding IIT in the early identification of COVID-19 virus severity to facilitate appropriate healthcare management which will help to relieve the pressure that has been put on the healthcare system in the country.”    The research aims to dissect the host response signatures during COVID-19 disease progression, identify clinically relevant biomarkers, apply mass spectrometry-based approaches, and translate the findings to allow the prognosis of COVID-19 patients.   The partnership will focus on five areas, including:  Biomarker discovery of COVID-19 severity at an early phase of infection  Immunoassays for the detection of biomarkers using single-molecule counting technology AI-driven short-listing of COVID-19 biomarkers for prognosis using immunoassay panel Immunoassay panel development for detection of biomarkers using single-molecule counting technology  Pathway enrichment-driven computational studies on drug repurposing for COVID-19 therapies   Photo caption: (L to R) Pankaj Kumar Joshi, Head of Commercial Marketing, Research Solutions for India, Merck, Sunil Punjabi, Managing Director for Life Science India, Merck, Prof. Suhas Joshi, Dean Alumni and Corporate Relations, IITB and Prof. Sanjeeva Srivastava, Professor Department of Biosciences and Bioengineering, IITB     ]]> <![CDATA[Cipla, Kemwell Biopharma in JV for respiratory biosimilars]]> https://biospectrumindia.com/news/95/19435/cipla-kemwell-biopharma-in-jv-for-respiratory-biosimilars.html https://biospectrumindia.com/news/95/19435/cipla-kemwell-biopharma-in-jv-for-respiratory-biosimilars.html Wed, 25 Aug 2021 15:35:00 +0530 Mumbai-based pharma firm Cipla and Bengaluru-based contract development and manufacturing organisation (CDMO) Kemwell Biopharma have announced the execution of a joint venture (JV) agreement to develop, manufacture and commercialise biosimilars for global markets. For this purpose, a joint venture company shall be incorporated with an aim to enter the respiratory biosimilars space.    Under the terms of the agreement, the joint venture will leverage Cipla and Kemwell’s complementary strengths for end-to-end product development, clinical development, regulatory filings, manufacturing and commercialisation of biopharmaceutical products. Cipla’s respiratory prowess combined with Kemwell’s expertise in biologics will accelerate bringing these essential products to market.     Umang Vohra, MD & Global CEO, Cipla, said, “This development reinforces our strength as leaders in respiratory therapy and is in line with our aspiration of global lung leadership. Guided by our purpose of ‘Caring for life’ our partnership with Kemwell will help serve unmet needs of patients across the globe.”   Anurag Bagaria, Chairman and CEO, Kemwell, said, “We are excited about combining the strengths of Cipla’s expertise in the development and commercialisation of respiratory products and Kemwell’s biologics capabilities. Through this JV, we aim to make cost-effective biotherapeutics available to more patients globally.” ]]> <![CDATA[Bharat Biotech launches global Chikungunya vaccine Phase II/III trial in Costa Rica]]> https://biospectrumindia.com/news/95/19431/bharat-biotech-launches-global-chikungunya-vaccine-phase-ii-iii-trial-in-costa-rica.html https://biospectrumindia.com/news/95/19431/bharat-biotech-launches-global-chikungunya-vaccine-phase-ii-iii-trial-in-costa-rica.html Wed, 25 Aug 2021 11:15:00 +0530 South Korea-based International Vaccine Institute (IVI) has announced that the first participant has received Bharat Biotech's Chikungunya vaccine candidate (BBV87) in Phase II/III clinical trial in Costa Rica, marking the start of a multi-country study led by IVI in partnership with Bharat Biotech International Ltd (BBIL) and funded by the Coalition for Epidemic Preparedness Innovations (CEPI) with support from the Ind-CEPI mission of the Department of Biotechnology (DBT).   IVI is advancing clinical development of BBV87 through a Phase II/III randomised, controlled trial to evaluate the safety and immunogenicity of a 2-dose regimen of BBV87 Chikungunya vaccine in healthy adults at nine clinical trial sites across five countries with endemic Chikungunya.   In addition to the trial at Clinica San Agustin in Costa Rica, trials are expected to begin in Panama and Colombia by September 2021 and in Thailand and Guatemala soon after.   The Global Chikungunya vaccine Clinical Development Program (GCCDP) seeks to develop and manufacture an affordable Chikungunya vaccine with the aim of achieving WHO prequalification to enable its distribution in low- and middle-income countries, consistent with CEPI’s core commitment to equitable access, affordability and sustainability.   As needed, CEPI or BBIL may propose a third-party for manufacturing of a stockpile of the investigational product to be used for further clinical trials in outbreak conditions to advance vaccine development, or pursuant to an emergency use authorisation in emergency situations based on national or international guidance (such as by the WHO).           ]]> <![CDATA[Livinguard's face mask fabric effective against Indian Isolate of SARS CoV-2]]> https://biospectrumindia.com/news/95/19427/livinguards-face-mask-fabric-effective-against-indian-isolate-of-sars-cov-2.html https://biospectrumindia.com/news/95/19427/livinguards-face-mask-fabric-effective-against-indian-isolate-of-sars-cov-2.html Tue, 24 Aug 2021 16:00:00 +0530 Swiss firm Livinguard has announced that its technology has been proven effective against the Indian isolate of SARS COV 2 - COVID-19, wild version. The tests were carried out by New Delhi-based National Institute of Immunology (NII) on Livinguard’s face mask fabric. The detailed results indicate that each layer of the Livinguard mask has an average of > 99 per cent effectiveness against the Indian isolate of SARS CoV-2, the wild strain circulating within our population.  The principle underlying the Livinguard technology is the deactivation of microbes including bacteria and viruses. The technology applies a positive charge at the molecular level to textile surfaces, making them more powerful than the negative charge of microbes. Therefore, microbes are deactivated when they encounter textiles treated with Livinguard Technology. Textiles treated with Livinguard Technology have also been proven to deactivate viruses, including SARS-CoV-2 by researchers at the Free University Berlin and the University of Arizona. Furthermore, Livinguard Technology is safe for humans and the environment. The company is now focusing on pivoting its production facility to scale the delivery of its sustainable hygiene technology worldwide. ]]> <![CDATA[India's first mRNA-based vaccine moves into Phase II/III trial]]> https://biospectrumindia.com/news/95/19429/indias-first-mrna-based-vaccine-moves-into-phase-ii-iii-trial.html https://biospectrumindia.com/news/95/19429/indias-first-mrna-based-vaccine-moves-into-phase-ii-iii-trial.html Tue, 24 Aug 2021 12:00:00 +0530 Gennova Biopharmaceuticals, the Pune-based biotechnology company, working on the nation's first mRNA-based COVID-19 vaccine, submitted the interim clinical data of the Phase I study to the Central Drugs Standard Control Organisation (CDSCO), the Government of India's National Regulatory Authority (NRA). Vaccine Subject Expert Committee (SEC) reviewed the interim Phase I data and found that HGCO19 was safe, tolerable, and immunogenic in the participants of the study. Gennova submitted the proposed Phase II and Phase III study entitled "A Prospective, Multicentre, Randomized, Active-controlled, Observer-blind, Phase II study seamlessly followed by a Phase III study to evaluate the Safety, Tolerability, and Immunogenicity of the candidate HGCO19 (COVID-19 vaccine) in healthy subjects" which was approved by the office of the DCG(I), CDSCO. The study will be conducted in India at approximately 10-15 sites in Phase II and 22-27 sites in Phase III. Gennova plans to use the DBT-ICMR clinical trial network sites for this study. Gennova's mRNA-based COVID-19 vaccine development program was partly funded by the Department of Biotechnology (DBT), Govt. of India under Ind CEPI, way back in Jun 2020. Later on, the DBT further supported the program under the Mission COVID Suraksha- The Indian COVID-19 Vaccine Development Mission, implemented by BIRAC. ]]> <![CDATA[Philips unveils air mask with innovative technology]]> https://biospectrumindia.com/news/95/19412/philips-unveils-air-mask-with-innovative-technology.html https://biospectrumindia.com/news/95/19412/philips-unveils-air-mask-with-innovative-technology.html Fri, 20 Aug 2021 15:20:00 +0530 Royal Philips has unveiled the Philips Fresh Air Mask that will protect from rising air pollution levels in the country. Equipped with a four-layered, high filtration, non-valve filter design, the Philips Fresh Air Mask has a two-way filtration system so that both inhaled and exhaled air passes through the filter.   The fan module is also specially designed to avoid spreading filtered exhaled air horizontally outward, which could potentially affect those in the vicinity of the mask wearer. The filter should be replaced after 40 hours of wear. When used at longer intervals, it is recommended to replace the filter at least every two weeks.    The product comes with a reusable cover that is crafted with air mesh and precise 3D laser cutting, that properly fits on any face and blends in with any look. It has a charging port for the fan module which can work for 2 to 3.5 hours after charging. To guarantee filtration efficiency, the consecutive duration of use of a single disposable filter is recommended to be no longer than 40 hours.   Philips Fresh Air Mask coupled with an air-fluid dynamic design delivers an air ventilation performance that provides fresh air every second, thereby decreasing humidity, temperature, and CO2 levels behind the mask.   Vidyut Kaul, Head, Personal Health, Philips Indian Subcontinent said, “It is a state-of-the-art product which combines comfortable breathing with filtration efficiency and stylish looks. It is an easy and practical way to ensure you and your family are protected from air pollution.” ]]> <![CDATA[Enzene obtains marketing authorisation for Romiplostim biosimilar drug in India]]> https://biospectrumindia.com/news/95/19408/enzene-obtains-marketing-authorisation-for-romiplostim-biosimilar-drug-in-india.html https://biospectrumindia.com/news/95/19408/enzene-obtains-marketing-authorisation-for-romiplostim-biosimilar-drug-in-india.html Fri, 20 Aug 2021 11:30:00 +0530 Enzene Biosciences, a subsidiary of Alkem Laboratories, has announced a successful Marketing Authorization (MA) from the Drug Controller General of India (DCGI) for its second biosimilar drug 'Romiplostim', indicated for the treatment of chronic Immune Thrombocytopenic Purpura (ITP) in adults.   In doing so, Enzene becomes the only biopharmaceutical company in India to offer all three dosage strengths of the drug (125mcg, 250mcg, and 500mcg).   ITP is a rare haematological disorder (prevalently autoimmune) with a primary clinical presentation of aberrantly low platelet levels, and symptoms including an increased bruising and bleeding tendency.   Romiplostim, a therapeutic fusion protein, acts as a thrombopoiesis stimulating factor, thereby restoring platelet levels and ameliorating the disease. As such, it remains one of the most reliable long-term treatment options for ITP patients.   Dr Himanshu Gadgil, Whole Time Director, Enzene said, "With the approval of Enzene's Romiplostim drug in India, we are happy to bring this life-saving therapy to ITP patients. Enzene is now actively developing strategic partnerships to further expand global access to this therapy."      ]]> <![CDATA[StanPlus to introduce air ambulance services pan India]]> https://biospectrumindia.com/news/95/19404/stanplus-to-introduce-air-ambulance-services-pan-india.html https://biospectrumindia.com/news/95/19404/stanplus-to-introduce-air-ambulance-services-pan-india.html Thu, 19 Aug 2021 12:00:00 +0530 StanPlus, a leading private patient logistics and emergency medical response company, has announced its foray into the air ambulance space. While the company has been operating air ambulances during the COVID-19 pandemic amid the increased demand for transferring critical patients, StanPlus will now systematically pursue it as a new vertical.    The company’s air ambulances offer COVID, non-covid, emergency, neonatal, ECMO and cargo transfers. Each cutting-edge ambulance is equipped with the best quality monitors, ventilators, oxygen, and emergency boxes, etc.    StanPlus is currently aggregating the best resources in the market. It is utilising its in-built fleet software for technical support and input, while also creating a specific tech platform for air ambulances. The company is creating dedicated teams across the country.    Prabhdeep Singh, Founder and CEO – StanPlus, said, “At the moment, there are very few players in this market and it lacks standardisation. Therefore, it is ripe for transformation by a player such as us that offers advanced, regulated and high-quality services.” ]]> <![CDATA[HealthCare atHOME buys 100% stake in SuVitas]]> https://biospectrumindia.com/news/95/19403/healthcare-athome-buys-100-stake-in-suvitas.html https://biospectrumindia.com/news/95/19403/healthcare-athome-buys-100-stake-in-suvitas.html Thu, 19 Aug 2021 11:50:00 +0530 Delhi NCR-based health-tech company HealthCare at HOME (HCAH) has acquired SuVitas Holistic Healthcare, a Bengaluru & Hyderabad-based transition care company in an undisclosed amount.   SuVitas will become a 100 per cent subsidiary of the HCAH which will help HCAH to build India’s largest and most clinically accomplished chronic and pre and post-hospital focussed healthcare delivery platform that acts as a ‘Hospital outside of the Hospital.’    “Going forward, our intention is to take this business to 1,500 beds in the next four to five years. In revenue terms, we expect to move up from over Rs 100+ crore currently to about Rs 800-1000 crore in the next four to five years using both organic and inorganic strategies,” said Vivek Srivastava, Co-Founder & CEO, HCAH.   "One of the founders of SuVitas – Dr Ramesh Byrapaneni will also join HCAH Board. With SuVitas running centres at Bengaluru and Hyderabad, the acquisition will help to make our reach much stronger in South India too,” said Srivastava. ]]> <![CDATA[Crysta IVF opens Indore centre]]> https://biospectrumindia.com/news/95/19396/crysta-ivf-opens-indore-centre.html https://biospectrumindia.com/news/95/19396/crysta-ivf-opens-indore-centre.html Wed, 18 Aug 2021 15:05:00 +0530 Delhi-based Crysta IVF has launched a centre in Indore. The centre is guided by Dr Hemant Athavale who has more than 25 years of experience and Dr Mangala Athavale with 40 years of expertise in infertility-related treatments.    The Indore centre hosts various treatments such as IVF, IUI, embryology and surrogacy. The cost of IVF treatment varies for each fertility case depending on various factors such as the amount of stimulation required, egg donor, age, freezing of eggs or sperms, usage of advanced fertility treatment such as laser-assisted hatching, ICSI, Tesa etc. The centre at Indore is well-equipped with advanced technology to cure different types of infertility problems.    Dheeraj Jain, Founder, Crysta IVF, said “With this centre at Indore, we hope to make fertility treatments accessible and affordable to all.    The centre in Indore is part of the company’s ambition of launching 12 new centres in the next nine months. ]]> <![CDATA[Venus Remedies registers Rs 14.59 Cr net profit in Q1 FY 2021-22]]> https://biospectrumindia.com/news/95/19386/venus-remedies-registers-rs-14-59-cr-net-profit-in-q1-fy-2021-22.html https://biospectrumindia.com/news/95/19386/venus-remedies-registers-rs-14-59-cr-net-profit-in-q1-fy-2021-22.html Mon, 16 Aug 2021 19:35:00 +0530 Venus Remedies has posted a sevenfold increase in net profit in the first quarter of this financial year as compared to the corresponding period last year.   Announcing its unaudited financial results for the quarter ending June 30, Venus Remedies stated that its net profit recorded an increase of 629.5 per cent, rising to Rs 14.59 crore in the first quarter of FY 2021-22 from Rs 2.00 crore in the corresponding quarter of the previous year.   Likewise, the company’s net profit percentage to total revenue grew from 1.11 per cent to 10.51 per cent and the EBIDTA percentage to revenue from 12.41 per cent to 15.55 per cent, reflecting impressive fast-paced growth.   “Our profitability growth in the first quarter of this financial year was mainly driven by robust sales of the company’s critical care products in the domestic market. This consequently resulted in lower freight costs and other selling expenses. The concerted efforts we have put in and the resources we have mobilised over the past two years to strengthen our relations with suppliers and customers are paying off,” said Saransh Chaudhary, President, Global Critical Care, Venus Remedies. ]]> <![CDATA[4baseCare unveils India’s largest population-specific tumour gene panel ]]> https://biospectrumindia.com/news/95/19383/4basecare-unveils-indias-largest-population-specific-tumour-gene-panel-.html https://biospectrumindia.com/news/95/19383/4basecare-unveils-indias-largest-population-specific-tumour-gene-panel-.html Mon, 16 Aug 2021 17:50:00 +0530 Bengaluru-based 4baseCare has launched TARGT Indiegene, a population-specific tumour gene panel derived from whole exome and whole transcriptome data of over 1500 cancer patients across 28 different cancer types.   Most of the patients were presented with stage III/ IV disease, and presented with disease progression and had exhausted all the options in the standard of care.   The TARGT Indiegene cancer panel is based on insights generated from tumour tissues of Indian cancer patients resulting in better success rates using precision medicine in the management of cancer.   The insights from research have helped build the largest resource of mutational signatures identified in cancer patients in India. Research has provided insights into 1044 unique genes across 28 different cancer types with mutational landscape and associated mutations.   Dr Kumar Prabhash, Professor and Medical Oncologist at TMH, Mumbai and one of the collaborators for the project said, "The availability of TARGT Indiegene kind of a cancer gene panel validated on Indian patient tumour samples, the oncologists will have better decision making capability lead by science towards precision oncology solutions that will improve the affordability and timely availability of accurate gene-testing reports for cancer patients."     ]]> <![CDATA[Glenmark posts PAT growth of 24.5 % in Q1 FY22]]> https://biospectrumindia.com/news/95/19371/glenmark-posts-pat-growth-of-24-5-in-q1-fy22.html https://biospectrumindia.com/news/95/19371/glenmark-posts-pat-growth-of-24-5-in-q1-fy22.html Fri, 13 Aug 2021 21:20:00 +0530 Glenmark Life Sciences (GLS) announced its first financial results post listing, for the quarter ended June 30, 2021. For the first quarter of FY22, Glenmark Life Sciences registered revenue from operations of Rs 5249.0 million, recording YoY growth of 32.2 per cent. Revenues from the Generic API segment increased 38.3 per cent YoY to Rs 4,803.4 million during the quarter driven by growth across all geographies. The regulated markets accounted for 66.5 per cent of net sales, growing at 30.5 per cent YoY.    Earnings Before Interest, Tax, Depreciation and Amortization (EBITDA) stood at Rs 1,644.4 million for the first quarter growing at 17.9 per cent YoY. EBITDA margin for the quarter was 31.3 per cent. Profit After Tax (PAT) was at Rs 1,009.1 million, registering a growth of 24.5 per cent against the first quarter of the previous financial year.    Commenting on the company’s Q1 FY22 performance, Dr Yasir Rawjee, MD and CEO, Glenmark Life Sciences said, “Today we have embarked on a good start in Q1 FY22, with the business delivering strong growth. Our generic API business has delivered robust growth across all geographies. Increased demand in both regulated and emerging markets have fuelled this growth. However, the CDMO business, being cyclical, was affected due to phasing of customer orders this quarter and we expect it to pick up the pace again from Q2 FY22.”    Bhavesh Pujara, CFO, Glenmark Life Sciences, “We started the financial year 2022 on a strong note with our revenues growing at 32.2 per cent YoY in the first quarter. Our continuous focus on cost reduction projects and cost controls have helped us overcome some of the headwinds on raw material prices and we closed the quarter with a healthy EBITDA margin of 31.3%. Also following the objects of the IPO, we have repaid all of the outstanding debt owed to our parent and have now become a debt-free company."   The company filed nine DMF/CEPs across major markets (i.e. US, Europe, Japan, Russia, Brazil, South Korea, Taiwan, Canada, China and Australia) during Q1 FY22 and cumulative filing stands at 407 as of June 30, 2021. ]]> <![CDATA[Dr Cyrus Poonawalla receives Lokmanya Tilak National Award 2021]]> https://biospectrumindia.com/news/95/19370/dr-cyrus-poonawalla-receives-lokmanya-tilak-national-award-2021.html https://biospectrumindia.com/news/95/19370/dr-cyrus-poonawalla-receives-lokmanya-tilak-national-award-2021.html Fri, 13 Aug 2021 21:05:00 +0530 Dr Cyrus Poonawalla, Chairman, Poonawalla Group has received the Lokmanya Tilak National Award 2021. The award was given by Lokmanya Tilak Smarak Trust in Pune in the presence of Dr Deepak J Tilak, President of Tilak Samrak Mandir and former Union Minister Sushil Kumar Shinde.   Poonawalla will be felicitated for his contribution to the health sector during the COVID-19 pandemic.     ]]> <![CDATA[Wockhardt partners with RDIF to produce Sputnik V and Sputnik Light vaccines]]> https://biospectrumindia.com/news/95/19364/wockhardt-partners-with-rdif-to-produce-sputnik-v-and-sputnik-light-vaccines.html https://biospectrumindia.com/news/95/19364/wockhardt-partners-with-rdif-to-produce-sputnik-v-and-sputnik-light-vaccines.html Fri, 13 Aug 2021 08:00:00 +0530 The Russian Direct Investment Fund (RDIF, Russia’s sovereign wealth fund), and Mumbai-based Wockhardt have partnered to produce and supply Sputnik V and Sputnik Light vaccines against COVID-19. The agreement was reached under the aegis of Enso Healthcare (part of Enso Group), RDIF's coordination partner for sourcing Sputnik V vaccines in India. Sputnik V is based on a proven and well-studied platform of human adenoviral vectors and uses two different vectors for the two shots in a course of vaccination, providing immunity with a longer duration than vaccines using the same delivery mechanism for both shots. While Sputnik Light is the first component of Sputnik V and is based on human adenovirus serotype 26. Sputnik V demonstrates 83.1% efficacy against the Delta variant of coronavirus - higher than many other vaccines. The vaccine shows 6 times reduction of infection risk. Sputnik V is also 94.4% effective against hospitalisations with 18 times reduction in hospitalisation risk. ]]> <![CDATA[Hester Biosciences registers net profit of Rs 12.24 Cr in Q1 FY22]]> https://biospectrumindia.com/news/95/19356/hester-biosciences-registers-net-profit-of-rs-12-24-cr-in-q1-fy22.html https://biospectrumindia.com/news/95/19356/hester-biosciences-registers-net-profit-of-rs-12-24-cr-in-q1-fy22.html Thu, 12 Aug 2021 14:15:00 +0530 Leading animal healthcare company, Hester Biosciences reported a standalone net profit of Rs 12.24 crore for the quarter ended June 2021 as against a net profit of Rs 7.62 crore in the corresponding period last year – growth of 60 per cent. Revenue from operations for the Q1FY22 was reported at Rs 58.51 crore, a growth of 50 per cent as compared to revenue of Rs 38.88 crore in the corresponding period last year. EPS for Q1FY22 was reported at Rs 14.38 per share. The company achieved an improved operational and financial performance in Q1 FY22 as compared to the corresponding quarter of FY21. The EBITDA margin was reported at 31.02 per cent and the net profit margin at 20.92 per cent in Q1FY22. The market and economic recovery has supported well for the growth of the poultry and animal industry and is expected to continue in the coming period. The company is constantly investing in the geographical market expansion and marketing manpower to achieve the budgeted topline.During Q1 FY22, the overall topline grew by 50 per cent, compared to Q1FY21 which was affected by a nationwide lockdown during the initial period of the pandemic. Overall, the sales of vaccines have registered a growth of 41 per cent in Q1 FY22, and the sale of Health Products have registered a growth of 94 per cent in Q1 FY22. Domestic sales have registered a growth of 61 per cent in Q1 FY22. The opening up of the domestic market has resulted in a higher demand for the products.        Export sales have registered a marginal de-growth of 8 per cent in Q1 FY22. Export orders are affected due to restricted cargo movements globally.  ]]> <![CDATA[Fidelity Health Services to foray into US, EU markets]]> https://biospectrumindia.com/news/95/19354/fidelity-health-services-to-foray-into-us-eu-markets.html https://biospectrumindia.com/news/95/19354/fidelity-health-services-to-foray-into-us-eu-markets.html Thu, 12 Aug 2021 13:10:00 +0530 Fidelity Health Services aims to expand its territorial footprint in the US and the EU regions. The strategic expansion will allow the company to fulfil the mushrooming needs of pharmaceutical companies based out in these markets.Fidelity Health Services provides end-to-end pharmacovigilance (PV) and ad-hoc PV services to bio-pharmaceuticals companies. Besides catering to five pharmaceutical companies and a few global CROs as their outsourcing partner for pharmacovigilance services, the company has been offering its end-to-end services for the last five years to one of the top generic pharma companies, empowering it to manufacture highly valued products in 30 global markets. From the initial set up of serviceable offices in Pune and Mumbai, India to branching out its operations in the UK and Toronto, Canada, the brains of the company have come a long way to scale its business operations in recent years. Fidelity Health Services recorded a CAGR of 35 per cent in the last quarter, with a cumulative CAGR of around 50 per cent in the last five years. If all goes as planned, the company targets to achieve a revenue of $2 million in 2021-22.Dr Pramod Dhembare, Founder, Fidelity Health Services, said, “As more and more pharmaceutical companies aim to launch their products in the North American & European Union markets, we intend to go ‘International’ and seize this business opportunity to fully support such companies to meet their objectives while strengthening our balance sheet.”The recruitment process of Fidelity Health Services stayed functional and onboarded 20 employees to match the increasing business deliverables for its clients. Going forward, the company aims to hire 15-20 per cent of new employees in operational and quality departments to fuel its expansion plans and meet the new business requirements. ]]> <![CDATA[Syngene expands biopharma-manufacturing capacity]]> https://biospectrumindia.com/news/95/19360/syngene-expands-biopharma-manufacturing-capacity.html https://biospectrumindia.com/news/95/19360/syngene-expands-biopharma-manufacturing-capacity.html Thu, 12 Aug 2021 13:00:00 +0530 Syngene International has announced the expansion of its biomanufacturing capacity. The company has set up and commissioned a new microbial cGMP facility and has also expanded the capacity of its mammalian cell manufacturing facility to extend end-to-end Chemistry, Manufacturing and Control (CMC) development solutions for its global clients. Both facilities are located at its Biocon Park campus in Bengaluru, India. The new microbial facility has two fermenters of 200 Litres and 500 Litres capacity.  The microbial facility will provide further integration opportunities with the Company’s existing Discovery and Development capabilities and extend service offerings in the space of GMP manufacturing of plasmid DNA and mRNA.  In addition to this, another 2000L single use bioreactor will be added to the USFDA and EMA compliant mammalian manufacturing facility. This is expected to strengthen Syngene’s service offerings for commercial supply. Jonathan Hunt, Managing Director and Chief Executive Officer, Syngene International Limited said “Use of digitalization and automation tools like electronic quality records and digital signatures will not only help avoid the risk of human errors, but also decrease operational costs and improve time-to-market. Both the facilities are supported by proven processes for efficient, scalable, customized and regulator-compliant commercial manufacturing.”   ]]> <![CDATA[Mankind Pharma to felicitate Indian Olympic players]]> https://biospectrumindia.com/news/95/19351/mankind-pharma-to-felicitate-indian-olympic-players.html https://biospectrumindia.com/news/95/19351/mankind-pharma-to-felicitate-indian-olympic-players.html Wed, 11 Aug 2021 19:25:00 +0530 Mankind Pharma has come forward to recognise the hard work and dedication of Indian athletes competing in the Tokyo Olympics. The brand will be rewarding players who represented India and garnered fourth position to salute them and encourage their determination and hard work. Mankind Pharma will be facilitating the players with a token of appreciation and gratitude for their exceptional performance. The company has decided to give a total amount of Rs 2.20 crore as a cumulative reward. Each player of the Women's Hockey team, a total of 16 players, with 11 lakhs rupees and adding to that the pharma company is rewarding Boxer Satish Kumar, Wrestler Deepak Punia, Shooter Saurabh Chaudhary and Golfer Aditi Ashok, who will be given a sum of Rs 11 lakh each for their bravery and hard work. Rajeev Juneja, MD and Vice Chairman, Mankind Pharma, said, “As a leader in the industry, we want to appreciate the hardships and sacrifices they have put in over the years. Such players inspire the whole country and motivate the younger generation to earn honours for the country.” ]]> <![CDATA[Lord's Mark invests Rs 100 Cr in health & hygiene e-commerce platform]]> https://biospectrumindia.com/news/95/19347/lords-mark-invests-rs-100-cr-in-health-hygiene-e-commerce-platform.html https://biospectrumindia.com/news/95/19347/lords-mark-invests-rs-100-cr-in-health-hygiene-e-commerce-platform.html Wed, 11 Aug 2021 16:50:00 +0530 Mumbai-based Lord's Mark Group will invest Rs 100 crores in its newly launched health and hygiene e-commerce platform- The Hygiene India.   The investment will be used in adding new products to the portfolio, boosting research and development, enhancing the technological capabilities, building manufacturing capabilities and for brand development.   The Hygiene India has launched a holistic product range for essential and preventive health care based on indigenous wisdom and natural ingredients along with game-changing diagnostic kits. The products comprise medicines for essential care, essential care kits, IVD kits, immunity boosters, etc.   The product ranges are being launched under three brand names - SafeSehat for health care product range, MarkoSafe for home care product range and Safelite for Sanitary pads.   Sachidanand Upadhyay, Director, The Hygiene India said, "The Lord's Mark Group aims to provide superior quality health and home care products to every Indian household at affordable prices. The Hygiene India has been launched for achieving this goal. The plans are around making it India's largest care enabler and one-stop-shop for our customers. The investments will help in expediting the growth of this unique e-commerce venture."         ]]> <![CDATA[Lupin posts gross profit of Rs 27,094 M in Q1 FY2022]]> https://biospectrumindia.com/news/95/19341/lupin-posts-gross-profit-of-rs-27094-m-in-q1-fy2022.html https://biospectrumindia.com/news/95/19341/lupin-posts-gross-profit-of-rs-27094-m-in-q1-fy2022.html Wed, 11 Aug 2021 09:35:00 +0530 Lupin reported its financial performance for the quarter ending June 30, 2021. In Q1 FY2022, the gross profit was registered at Rs 27,094 million compared to Rs 24,417 million in Q4 FY2021, with a gross profit margin of 63.9 per cent. The gross profit was buoyed by the $50 million received from Boehringer Ingelheim for achieving key milestones for its novel MEK inhibitor compound collaboration. EBITDA was registered at Rs 9,926 million and profit after tax was registered at Rs 5,480 million.   Personnel cost was 18.5 per cent of sales at Rs 7,837 million compared to Rs 6,402 million in Q4 FY2021. Manufacturing and other expenses were at 24.3 per cent of sales at Rs 10,309 million compared to Rs 11,178 million in Q4 FY2021. Investment in R&D for the quarter was at Rs 3,737 million (8.8 per cent of sales).      The operating working capital was at Rs 59,615 million as of June 30, 2021. Capital expenditure for the quarter was Rs 1,057 million, net debt as of June 30, 2021, stands at Rs (-)3,453 million. Net debt-equity for the company as on June 30, 2021, stands at (-)0.02.   Nilesh Gupta, MD, Lupin said, “While the quarter’s profits were bolstered by the Boehringer Ingelheim MEK programme income, despite a tough operating environment, we see substantial room for growth. We remain committed to growing our US business both with our inline products as well as the ramp-up of Albuterol and Brovana, to continue above-market growth in India, and ensure growth in every part of the business. We  see meaningful uplift in the second half and remain focused on our journey of expanding margins through driving strong double-digit revenue growth and optimising costs, while ensuring the safety of our people and the highest standards of compliance.” ]]> <![CDATA[Aurabeat unveils patented AG+ anti-covid air purifier in India]]> https://biospectrumindia.com/news/95/19336/aurabeat-unveils-patented-ag-anti-covid-air-purifier-in-india.html https://biospectrumindia.com/news/95/19336/aurabeat-unveils-patented-ag-anti-covid-air-purifier-in-india.html Tue, 10 Aug 2021 16:20:00 +0530 Aurabeat, US FDA approved anti-Covid Class 2 medical device for SARS-COV-2 disinfection, has been launched in the Indian market. Hong Kong-based Aurabeat has developed the patented AG+ five-stage sterilisation purifying technology after extensive research in the field of air filtration for over a decade.   Aurabeat’s AG+ Pro Silver Ion Antiviral Air Purifier cleans the air up to 3.4 times in one hour while actively eliminating bacteria and viruses from air and surfaces.    Apart from US FDA, the product is certified by MRI Global, ATCC (American Type Culture Collection), SGS (General Society of Surveillance-Geneva), FC, CE, ISO, UL, RoHS, UKRI Medical Research Council, CEN European Committee for Standardization. Aurabeat is used in over 200 hospitals, 200+ schools protecting the air from COVID-19 in more than 40 countries.    According to the actual experimental test results using COVID-19 viruses in a US virology laboratory, MRI Global, Aurabeat AG+ Silver ion Antiviral air purifier proved to effectively eliminate 99.9 per cent COVID-19 in 15 minutes. Other experimental tests have also proven that Aurabeat AG+ silver ion air sterilisation purifying technology can kill 99.9 per cent influenza viruses, fungi staphylococcus aureus and E.coli.      ]]> <![CDATA[Lincoln Pharma posts standalone net profit of Rs 17.38 Cr in Q1FY22]]> https://biospectrumindia.com/news/95/19335/lincoln-pharma-posts-standalone-net-profit-of-rs-17-38-cr-in-q1fy22.html https://biospectrumindia.com/news/95/19335/lincoln-pharma-posts-standalone-net-profit-of-rs-17-38-cr-in-q1fy22.html Tue, 10 Aug 2021 16:05:00 +0530 Lincoln Pharmaceuticals has reported a standalone net profit of Rs 17.38 crore for the Q1FY22 ended June 2021 as against a net profit of Rs 14.99 crore in the corresponding period last year, a growth of 15.92 per cent. Net revenue from operations in Q1FY22 was reported at Rs 122.06 crore, higher by 18.49 per cent over the previous fiscal’s same quarter net revenue of Rs 103.01 crore.   EBITDA for Q1FY22 was reported at Rs 26.31 crore, a rise of 17.37 per cent as compared to EBITDA of Rs 22.42 crore in Q1FY21. In Q1FY22, EPS for Q1FY22 was at Rs 8.69 per share as compared to Rs 7.50 in the corresponding period last year.   Mahendra Patel, MD, Lincoln Pharmaceuticals, said, "We are confident to improve our growing numbers of revenue, margins and profitability in FY22. Our strategic growth initiatives, product and geographical expansion, operational efficiency and debt-free status are likely to maximise value for all stakeholders in the near to medium term. For the FY 21-22, the company is looking at a sales growth of 15-20 per cent while maintaining healthy EBITA and Net profit margins. Expanding the product basket, the company plans to introduce six to seven new products in the domestic markets and expects 20 -25 new dossiers approval for the exports market. Exports to the EU markets are likely to commence from Q4FY22."   During Q1FY22 ended June 2021, promoter group of Lincoln Pharmaceuticals increased holding in the company to 37.78 per cent - rise of 52 bps, from 37.26 per cent as of March 31, 2021.      Exports for Q1FY22 was reported at Rs 69.76 crore. The export business of the company has shown remarkable growth in the last few years and had increased to 65 per cent of total sales in FY21 from 11 per cent of total sales in FY13. The company currently exports to 60 plus countries including East & West Africa, Central and Latin America and Southeast Asia. For the FY21, exports grew 18.4 per cent to Rs 270 crore.   ]]> <![CDATA[Merck launches Pergoveris Pen for fertility treatment in India]]> https://biospectrumindia.com/news/95/19330/merck-launches-pergoveris-pen-for-fertility-treatment-in-india.html https://biospectrumindia.com/news/95/19330/merck-launches-pergoveris-pen-for-fertility-treatment-in-india.html Mon, 09 Aug 2021 19:25:00 +0530 Merck Specialties, the healthcare business of Merck in India, has launched Pergoveris Pen for advanced infertility treatment in India.   The launch emphasises the company’s motive of fulfilling unmet medical needs by providing an improved, convenient, and ready-to-use combination treatment option for women with a severe follicle-stimulating hormone (FSH) and luteinizing hormone (LH) deficiency.   The new Pergoveris® Pen allows an improved treatment experience for patients with severe FSH and LH deficiency upon prescription by an IVF specialist.    The novel first-hand version of the Pergoveris Pen is a breakthrough combination of a freeze-dried powder and solvent, reducing the probability of reconstitution errors. As a result, Pergoveris delivers with more precision and, hence, is more accessible to self-administration by patients during infertility treatment.   In addition, by eliminating the need for mixing, Pergoveris Pen is the world’s first combined therapy option for recombinant gonadotropins, demonstrating the efficacy, safety, and combinability of recombinant follitropin alfa with recombinant lutropin alfa, in a single ready to inject device, using Filled-By-Mass Technology, for infertile women in a physiological ratio of 2:1. ]]> <![CDATA[ICPA launches denture management kit for elderly]]> https://biospectrumindia.com/news/95/19318/icpa-launches-denture-management-kit-for-elderly.html https://biospectrumindia.com/news/95/19318/icpa-launches-denture-management-kit-for-elderly.html Fri, 06 Aug 2021 16:35:00 +0530 ICPA Health Products (ICPA), a leading pharmaceutical company and pioneer in the oral-health segment has introduced a denture management kit – Replay Kit, for the elderly. The kit consists of a complete denture hygiene and maintenance routine including a denture storage container, Fixon adhesive cream, Clinsodent cleanser and Clinsodent brush. ICPA has assembled the kit for easy-to-use, everyday denture management.   The denture adhesive called Fixon Cream helps hold the dentures securely in the mouth helping the user eat, speak, look and feel better. It seals out any food particles and prevents its ingress underneath the denture surface and increases the bite force by as much as 10 times. The denture cleanser called Clinsodent consists of effervescent cleansing tablets that help clean all water-insoluble residues from dentures. Its antibacterial formula kills germs that cause odour and plaque.   The Clinsodent brush is designed for optimum hygiene. The two types of nylon bristles on opposite heads of the brush are designed to effectively clean all surfaces and grooves in the dentures. The contoured design maximises control while handling the brush. ]]> <![CDATA[Novavax, Serum Institute seek nanoparticle COVID-19 vaccine approval in India]]> https://biospectrumindia.com/news/95/19311/novavax-serum-institute-seek-nanoparticle-covid-19-vaccine-approval-in-india.html https://biospectrumindia.com/news/95/19311/novavax-serum-institute-seek-nanoparticle-covid-19-vaccine-approval-in-india.html Fri, 06 Aug 2021 12:25:00 +0530 US-based Novavax with its partner, Serum Institute of India (SII), has announced that the companies have filed regulatory submissions for emergency use authorization of Novavax' recombinant nanoparticle protein-based COVID-19 vaccine candidate with Matrix-M adjuvant. The submission was recently made to the Drugs Controller General of India (DCGI)   In addition, the companies have also applied to the regulatory agencies in Indonesia and the Philippines.   SII and Novavax have now completed the submission of all modules required by regulatory agencies in India, Indonesia and the Philippines for the initiation of the review of the vaccine, including preclinical, clinical, and chemistry, manufacturing and controls data. A Good Manufacturing Practice joint site inspection of SII was successfully completed by DCGI in May 2021.   A submission to the World Health Organization (WHO) for emergency use listing (EUL) based on the DCGI submission is expected to be filed in August. The grant of EUL by the WHO is a prerequisite for exports to numerous countries participating in the COVAX Facility, which was established to allocate and distribute vaccines equitably to participating countries and economies.   Novavax' COVID-19 vaccine is packaged as a ready-to-use liquid formulation in a vial containing ten doses. The vaccination regimen calls for two 0.5 ml doses (5 microgram antigen and 50 microgram Matrix-M adjuvant) given intramuscularly 21 days apart. The vaccine is stored at 2°- 8° Celsius, enabling the use of existing vaccine supply and cold chain channels.   SII is manufacturing, and developing, and is responsible for commercializing the vaccine in India. Novavax and SII have cumulative commitments to provide more than 1.1 billion doses to the COVAX Facility. ]]> <![CDATA[Cipla posts PAT of Rs 715 crore in Q1 FY 22]]> https://biospectrumindia.com/news/95/19309/cipla-posts-pat-of-rs-715-crore-in-q1-fy-22.html https://biospectrumindia.com/news/95/19309/cipla-posts-pat-of-rs-715-crore-in-q1-fy-22.html Fri, 06 Aug 2021 10:20:00 +0530 Cipla has announced Q1 FY22 results. Income from operations has been reported at Rs 5504 crores, a growth of 27 per cent YoY. The EBITDA is at Rs 1346 crore, 28 per cent growth YoY and PAT at Rs 715 crore at 24 per cent YoY. The company reported an overall business growth of 68 per cent YoY with strong volume traction in core therapies and COVID-19 portfolio contribution.   Umang Vohra, MD and Global CEO, Cipla, said, “At Cipla, we feel proud to have contributed extensively to the fight against COVID-19 amid the second wave by ensuring continuous supply of life-saving medicines. I am pleased to see the robust demand led traction in core therapies across our branded markets and continued cost control leading to 27 per cent revenue growth and 24.5 per cent EBITDA margin for the quarter. In India, we maintained our market-beating performance as core therapies responded to demand triggers along with support from the covid portfolio during the second wave. I am delighted to witness the continued unlocking of our respiratory franchise in the US with market share expansion in Albuterol and strengthening of the portfolio with Arformoterol launch. Our South Africa private business continues to outperform the market. Our investments in creating a differentiated API portfolio have helped drive growth in the quarter." ]]> <![CDATA[Alembic Pharma bags US FDA approval for OCD caps]]> https://biospectrumindia.com/news/95/19301/alembic-pharma-bags-us-fda-approval-for-ocd-caps.html https://biospectrumindia.com/news/95/19301/alembic-pharma-bags-us-fda-approval-for-ocd-caps.html Thu, 05 Aug 2021 12:45:00 +0530 Alembic Pharmaceuticals has received final approval from the US Food & Drug Administration (US FDA) for its Abbreviated New Drug Application (ANDA) for Clomipramine Hydrochloride Capsules USP, 25 mg, 50 mg, and 75 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Anafranil Capsules, 25 mg, 50 mg, and 75 mg, of SpecGX LLC. Clomipramine Hydrochloride Capsules are indicated for the treatment of obsessions and compulsions in patients with Obsessive-Compulsive Disorder (OCD).   Clomipramine Hydrochloride Capsules USP, 25 mg, 50 mg, and 75 mg, have an estimated market size of $32 million for twelve months ending June 2021 according to IQVIA.   Alembic has a cumulative total of 149 ANDA approvals (131 final approvals and 18 tentative approvals) from the US FDA. ]]> <![CDATA[Hungary certifies Bharat Biotech's Covaxin with GMP compliance]]> https://biospectrumindia.com/news/95/19298/hungary-certifies-bharat-biotechs-covaxin-with-gmp-compliance.html https://biospectrumindia.com/news/95/19298/hungary-certifies-bharat-biotechs-covaxin-with-gmp-compliance.html Thu, 05 Aug 2021 10:00:00 +0530 Bharat Biotech's COVID-19 vaccine Covaxin has received Good Manufacturing Practices (GMP) compliance certificate from Hungary. National Institute of Pharmacy and Nutrition, Hungary has certified the GMP for the manufacture of Covaxin.The certificate of GMP is now listed on the EudraGMDP database which is the collection of records of the European Community of manufacturing authorisations and certificates of Good Manufacturing Practice.Bharat Biotech intends to submit documentation for emergency use authorisation to several additional countries worldwide, the company said.A tweet by Bharat Biotech mentions, "Another milestone in our account as COVAXIN receives GMP certificate from Hungary. This marks the 1st EUDRAGDMP compliance certificate received by Bharat Biotech from European regulatory. ]]> <![CDATA[Illumina steps-up to support sequencing-based COVID-19 surveillance in Mumbai]]> https://biospectrumindia.com/news/95/19292/illumina-steps-up-to-support-sequencing-based-covid-19-surveillance-in-mumbai.html https://biospectrumindia.com/news/95/19292/illumina-steps-up-to-support-sequencing-based-covid-19-surveillance-in-mumbai.html Wed, 04 Aug 2021 10:40:00 +0530 US-based Illumina has donated $1 million in sequencing capabilities to the Molecular Diagnostic Reference Laboratory at Kasturba Hospital, in the Municipal Corporate of Greater Mumbai, to help expand SARS-CoV-2 sequencing capabilities in the region and support the broader genomic surveillance effort across India.   Kasturba Hospital was the first hospital in Mumbai to begin sequencing SARS-CoV-2 this year and will examine how variants of the virus are being spread across India.   "Illumina believes in the democratisation of access to sequencing and we are committed to helping the regions of the world that carry most of the infectious disease burden to build genomics capabilities," said Francis deSouza, CEO, Illumina. "This donation will help to make NGS technology and expertise accessible in Mumbai, supporting the region and contributing to genomic surveillance in India more broadly."   The donation includes two of Illumina's newest next-generation sequencing (NGS) platforms, the NextSeq 2000, reagents, a rapid bioinformatics analysis platform (DRAGEN) and four years of service support for the sequencing installations. It is part of Illumina's broader philanthropic programme to provide access to NGS technology throughout the world to drive a global response that will be effective in supporting SARS-CoV-2 control efforts.     ]]> <![CDATA[Premas Biotech to bring vaccine technology effective against delta variant]]> https://biospectrumindia.com/news/95/19290/premas-biotech-to-bring-vaccine-technology-effective-against-delta-variant.html https://biospectrumindia.com/news/95/19290/premas-biotech-to-bring-vaccine-technology-effective-against-delta-variant.html Tue, 03 Aug 2021 15:30:00 +0530 Gurugram-based Premas Biotech has signed a licensing deal with Oravax Medical for the development and commercialisation in India, of its virus-like-particle COVID-19 vaccine technology.   Oravax Medical is a joint venture between Israel-based Oramed Pharmaceuticals and Premas Biotech. Oravax brings together a virus-like particle (VLP) vaccine technology, developed by Premas Biotech with Oramed’s proprietary protein oral delivery (POD) technology in the development of oral vaccines that are now only available via injection.   As Oravax maintains its focus on oral vaccines, it has licensed to Premas the right to develop an injectable version of its VLP technology to address the urgent need for a vaccine which is effective against the Delta variant.   Dr Prabuddha Kundu, Co-founder and MD, Premas Biotech said, “We are proud to have designed and developed an innovative vaccine technology, here in India. Our technology is based on our difficult-to-express proteins platform, D-Crypt, and we believe it has multi-dimensional advantages over other existing technologies."   Premas plans to manufacture, test, and potentially commercialize the injectable version of the VLP vaccine in India.   Oravax is gearing up to commence clinical trials for its oral COVID-19 vaccine, first in Israel, then in additional clinical sites internationally.      ]]> <![CDATA[Uniza Group ties up with Lysulin for diabetic nutritional supplement]]> https://biospectrumindia.com/news/95/19288/uniza-group-ties-up-with-lysulin-for-diabetic-nutritional-supplement.html https://biospectrumindia.com/news/95/19288/uniza-group-ties-up-with-lysulin-for-diabetic-nutritional-supplement.html Tue, 03 Aug 2021 13:45:00 +0530 Ahmedabad-based Uniza Group has entered into an exclusive tie-up with Lysulin - an innovator company from the US to launch Lysulin - a breakthrough evidence-based nutritional product for Indian Market. Lysulin is patented in the USA for the prevention of protein glycation using Lysine supplements and as a method of diabetes support using a supplement.UNIZA is a pharmaceutical venture of Pashupati Group. The company has set up a modern, state-of-the-art facility complying with WHO-GMP and PIC/S guidelines at Kadi near Ahmedabad, Gujarat. Having launched India business in August 2020, the company has gradually expanded its product range to over 80 SKU’s with a sale of Rs 25 crore in the first year.Sreekanth Seshadri, CEO and Managing Partner, Uniza Healthcare, said, "We endeavour to bring the best of global healthcare products to India and the launch of Lysulin, Schones and Keratizaare testimony to our commitment. The company is looking to introduce more innovative products in India. Focussed on dermatology, cardiology and diabetes management we offer products that include antifungals, anti-dandruff preparations, moisturizers, antibiotics, anti-allergic preparations, anti-acne, multi-vitamins, anti-hypertensives, oral hypoglycemic agents, lipid-lowering agents and iron preparations.""Our international business would mainly focus on ROW markets like Africa, LATAM, South East Asia and CIS countries and planning to file over 180 dossiers. Our Indian business is aiming to achieve sales of Rs 100 crore in FY 2021-22," said Saurin Parikh, MD, Uniza Group & Founder, Pashupati Group.   ]]> <![CDATA[Glenmark ties up with SaNOtize to commercialise COVID-19 nasal spray]]> https://biospectrumindia.com/news/95/19280/glenmark-ties-up-with-sanotize-to-commercialise-covid-19-nasal-spray.html https://biospectrumindia.com/news/95/19280/glenmark-ties-up-with-sanotize-to-commercialise-covid-19-nasal-spray.html Mon, 02 Aug 2021 14:45:00 +0530 Mumbai-based Glenmark Pharmaceuticals and Canadian biotech firm SaNOtize Research & Development Corp have announced an exclusive long term strategic partnership to manufacture, market and distribute its breakthrough Nitric Oxide Nasal Spray (NONS) for COVID-19 treatment in India and other Asian markets including Singapore, Malaysia, Hong Kong, Taiwan, Nepal, Brunei, Cambodia, Laos, Myanmar, Sri Lanka, Timor-Leste and Vietnam.    In March 2021, SaNOtize’s clinical trials showed NONS was a safe and effective antiviral treatment to prevent the transmission of COVID-19, shorten its course, and reduce the severity of symptoms. Available in the form of a simple nasal spray, it is designed to kill the virus in the upper airways, preventing it from incubating and spreading to the lungs. It is based on nitric oxide (NO), a natural nano-molecule with proven anti-microbial properties, and which has a direct effect on SARS-CoV-2, the virus causing COVID-19.   In early July 2021, Glenmark presented a proposal to the Subject Expert Committee of CDSCO for emergency approval for the import and marketing of the nasal spray.   The committee has recommended a Phase III clinical trial to be conducted in Indian patients in the weeks to follow. The Phase III clinical trial for NONS is expected to be completed, followed by a commercial launch under the brand name FabiSpray in India, by the fourth quarter of the calendar year 2021.    SaNOtize developed and patented a Nitric Oxide Releasing Solution platform technology (NORSTM) to treat and prevent microbial infections in 2017. Glenmark’s partnership with SaNOtize will bring in much  needed therapeutic relief to patients in India and Asia.  ]]> <![CDATA[MedPiper Technologies unveils resume builder for healthcare professionals]]> https://biospectrumindia.com/news/95/19279/medpiper-technologies-unveils-resume-builder-for-healthcare-professionals.html https://biospectrumindia.com/news/95/19279/medpiper-technologies-unveils-resume-builder-for-healthcare-professionals.html Mon, 02 Aug 2021 14:30:00 +0530 Bengaluru-based MedPiper Technologies has launched a resume builder specifically directed towards healthcare professionals. The new feature by MedPiper lists out all the important factors that hospitals and other healthcare organisations usually look at before hiring, like clinical experiences and medical licenses, that is generally not found in the standard resume format.The users can build their resumes according to a pre-set online template, certified by a senior panel of doctors and tested by over 300 healthcare practitioners, and they can revisit from time to time to edit their resume as and when they add new clinical experiences and update their medical education. MedPiper’s resume builder helps in crafting the resume step-by-step and ensures that it contains all the credentials required for increased visibility when it comes to job openings in hospitals. The feature can be used by all the users at MedPiper Connect, the exclusive career portal for doctors and hospitals.Nitthin Chandran, Co-founder and CEO, MedPiper Technologies said, “We created our resume builder to help showcase the entire career of a healthcare practitioner in a better light. From the time they graduate from medical college to job hunting and updating their medical knowledge in their opted fields of specialisation, the feature can be used at every stage of their career. The resume builder is an apt fit in the MedPiper ecosystem that aims to improve the career lifecycle of healthcare practitioners.” ]]> <![CDATA[Sun Pharma posts adjusted net profit at Rs 19,792 M in Q1 up 73% YoY]]> https://biospectrumindia.com/news/95/19273/sun-pharma-posts-adjusted-net-profit-at-rs-19792-m-in-q1-up-73-yoy.html https://biospectrumindia.com/news/95/19273/sun-pharma-posts-adjusted-net-profit-at-rs-19792-m-in-q1-up-73-yoy.html Fri, 30 Jul 2021 17:55:00 +0530 Sun Pharmaceutical Industries has reported the financials for the first quarter ending June 30, 2021. In Q1FY22, the consolidated sales from operations at Rs 96,694 million, a growth of 29 per cent over Q1 last year and 14 per cent over Q4 last year. India sales have been reported at Rs 33,084 million, up 39 per cent compared to Q1 last year. The US finished dosage sales at $380 million, a growth of 35 per cent over the same quarter last year. The Emerging Markets sales was at $218 million, up by 25 per cent over Q1 last year. The Rest of World sales was at $185 million, up by 35 per cent over Q1 last year.    The R&D investments are at Rs 5,926 million compared to Rs 4,206 million for Q1FY21. EBITDA at Rs 27,718 million, up by 59 per cent over Q1 last year, with a resulting EBITDA margin of 28.7 per cent. The adjusted net profit for the quarter was at Rs 19,792 million, up by 73 per cent YoY, after excluding the exceptional items of Rs. 6,311 million and relevant minority interest of Rs. 960 million. The adjusted net profit margin at 20.5 per cent compared to 15.3 per cent for Q1 last year. The company reported a net profit for Q1FY22 was at Rs 14,442 million.    Dilip Shanghvi, MD, Sun Pharma said, “We witnessed a strong Q1, driven by a combination of robust core business growth, low base and some sale of Covid products. We are enthused by the all-around growth across all our businesses compared to Q4 last year. Our India business continues to do well while our global speciality revenues have grown over Q4. We are happy with Ilumya’s performance which has grown both YoY and sequentially. We continue to focus on growing our overall business and simultaneously strengthening our global speciality portfolio. The recent in-licensing of Winlevi for the US and Canada is a step forward in this direction.”   ]]> <![CDATA[Lupin's Generic Health buys stake in Aus-based Southern Cross Pharma]]> https://biospectrumindia.com/news/95/19265/lupins-generic-health-buys-stake-in-aus-based-southern-cross-pharma.html https://biospectrumindia.com/news/95/19265/lupins-generic-health-buys-stake-in-aus-based-southern-cross-pharma.html Fri, 30 Jul 2021 12:35:00 +0530 Generic Health, an Australia-based wholly-owned subsidiary of global pharma major Lupin announced that it has entered into a definitive agreement under which Lupin will acquire 100 per cent of the shares of Southern Cross Pharma (SCP).Incorporated in Melbourne, Australia, SCP is engaged in developing, registering, and distributing generic products. As a part of the transaction, Generic Health will gain access to over 60 registered products having sales of over AUD 30 million (approximately $22 million). This will significantly increase Lupin’s value proposition and market share in the Australian market.Nilesh Gupta, MD, Lupin said, “The Southern Cross Pharma portfolio builds on our existing portfolio of prescription generics, over the counter and speciality range of products. This investment significantly increases our scale in Australia and reinforces our commitment to patients in Australia.”“The acquisition of SCP marks the next exciting chapter of growth for Generic Health. We will benefit from SCP’s portfolio of over 60 difficult-to-develop generic pharmaceutical products. This substantially strengthens our product offering and enables us to deliver enhanced value for our stakeholders, patients and communities,” said Ashutosh Damle, CEO, Generic Health.Neill Stacey, Managing Director and owner, SCP commented, “Over the past 20 years, SCP has had a preference to develop a portfolio of products that are more demanding than the standard generics. I am happy that the reach of Southern Cross Pharma’s products will increase through Lupin and Generic Health.”  ]]> <![CDATA[Roche launches oral therapy to treat Spinal Muscular Atrophy in India]]> https://biospectrumindia.com/news/95/19258/roche-launches-oral-therapy-to-treat-spinal-muscular-atrophy-in-india.html https://biospectrumindia.com/news/95/19258/roche-launches-oral-therapy-to-treat-spinal-muscular-atrophy-in-india.html Thu, 29 Jul 2021 18:45:00 +0530 Roche has announced the launch of Evrysdi (risdiplam), the first and only approved treatment in India for Spinal Muscular Atrophy (SMA) patients.   Evrysdi was first approved by the US FDA in August 2020 and is available in India within 11 months of US approval. Since its launch, over 4,000 SMA patients across 50+ countries have benefitted from Evrysdi.   Evrysdi is administered daily at home orally (it is supplied as a powder which is constituted into a liquid solution and taken once daily by mouth or feeding tube if required) and is designed to treat SMA by increasing production of the Survival Motor Neuron (SMN) protein. It is approved for the treatment of spinal muscular atrophy (SMA) in adults and children 2 months of age and older.   Evrysdi was approved by Indian health authorities after reviewing its efficacy and safety data from three global clinical studies designed to represent a broad spectrum of people living with SMA.    V Simpson Emmanuel, CEO and MD, Roche Pharma India, says, "The launch of Evrysdi in India is a fine example of Roche living its purpose of 'Doing now what patients need next'. This also marks our foray into rare disease treatment in India."   Roche has announced its Patient Support Programme (PSP) for Evrysdi. In the first two years of treatment, Roche provides three bottles free for every two bottles bought by the patient and from the third year onwards, Roche provides two bottles free for every one bottle bought by the patient. Roche will provide free home delivery of Evrysdi to every patient following consent from the patient/ caregiver and their HCPs.         ]]> <![CDATA[Laurus Labs registers revenue growth of 31 per cent at Rs 1,279 Cr]]> https://biospectrumindia.com/news/95/19257/laurus-labs-registers-revenue-growth-of-31-per-cent-at-rs-1279-cr.html https://biospectrumindia.com/news/95/19257/laurus-labs-registers-revenue-growth-of-31-per-cent-at-rs-1279-cr.html Thu, 29 Jul 2021 16:50:00 +0530 Laurus Labs has announced its Q1 FY22 results. The total net revenue was at Rs 1,279 crores, up 31 per cent (Y-o-Y), EBITDA at Rs 400 crores, up 41 per cent (Y-o-Y); EBITDA margins at 31 per cent; PAT at Rs 241 crore, up 40 per cent (Y-o-Y) and PAT margins at 19 per cent (Y-o-Y).   Commenting on the results announcement, Dr Satyanarayana Chava - CEO, Laurus Labs said, “Our synthesis business retained its growth momentum powered by the increased business from the existing clients and new clients; the segment registered strong growth with +95 per cent YoY, with ongoing commercial supplies for four products. In the API segment, oncology and ARV APIs registered healthy growth. In contrast, revenue from our other API witnessed a slowdown, and the growth is expected to restore from Q2 FY22, we remain confident of maintaining a growth trajectory in the Generic API business for FY22. In addition, Laurus Bio started contributing to the revenue and would add more from Q2 FY22, with the new fermentation capacities added in recombinant food protein.”    VV Ravi Kumar, ED and CFO, Laurus Labs said, "Our performance focus is on growth driven by superior execution and completing our Future Ready strategy with manufacturing capacity expansions - a combination of brown and greenfield in API, FDF, and Synthesis divisions. With sustained business opportunities, we remain confident of achieving sustainable return ratios in the FY2022-23 and beyond.”     ]]> <![CDATA[Biocon Biologics, Viatris receive US FDA approval for Semglee to treat diabetes]]> https://biospectrumindia.com/news/95/19251/biocon-biologics-viatris-receive-us-fda-approval-for-semglee-to-treat-diabetes.html https://biospectrumindia.com/news/95/19251/biocon-biologics-viatris-receive-us-fda-approval-for-semglee-to-treat-diabetes.html Thu, 29 Jul 2021 13:20:00 +0530 Biocon Biologics and Viatris announced that the US Food and Drug Administration (FDA) has approved Semglee (insulin glargine-yfgn injection) as the first interchangeable biosimilar product under the 351(k) regulatory pathway.Biocon Biologics, Executive Chairperson, Kiran Mazumdar-Shaw said, “We are proud to be the first to obtain approval of an interchangeable Biosimilar product in the US. It is a milestone achievement for both Biocon Biologics and our partner Viatris. This will allow pharmacy level substitution and thereby provide convenient and affordable access to Semglee, a quality Biosimilar Insulin Glargine.”Arun Chandavarkar, MD, Biocon Biologics said, “This interchangeability approval for Semglee by the US FDA, another first to our credit, is a testament to our scientific excellence and robust quality comparability data. This allows substitution at the pharmacy counter, thus expanding patient access and sets the stage for future approvals for our other insulin products.”The interchangeable Semglee product, which will allow substitution of Semglee for the reference product, Lantus, at the pharmacy counter, will be introduced before the end of the year. The company is eligible to have exclusivity for 12 months before the FDA can approve another biosimilar interchangeable to Lantus. Commercial preparations for launch are underway. Over the next few months, Viatris will transition the current product to the 351(k) interchangeable product.Semglee is indicated to control high blood sugar in adults with Type 2 diabetes and adults and pediatric patients with Type 1 diabetes. It is not recommended for the treatment of diabetic ketoacidosis. Semglee has an identical amino acid sequence to Lantus and is approved for the same indications.Michael Goettler, CEO, Viatris commented, “We are proud to achieve the industry’s first approval of an interchangeable biosimilar product in the US, which will help broaden access to this important diabetes medicine for patients, physicians, payers and providers. This is yet another important milestone for our company that not only continues to underscore the strength of our internal scientific capabilities but also supports our belief in the promising future of our company as we continue to work to identify innovative ways to increase access to complex treatments for patients.”Rajiv Malik, President, Viatris added, “We are pleased to have once again worked with the FDA to achieve the very historic approval of the first interchangeable biosimilar in the US and are grateful to our partner, Biocon Biologics, for their collaboration in achieving this milestone." ]]> <![CDATA[Dr Reddy's, ICICI Lombard launch cashless digital health solution]]> https://biospectrumindia.com/news/95/19239/dr-reddys-icici-lombard-launch-cashless-digital-health-solution.html https://biospectrumindia.com/news/95/19239/dr-reddys-icici-lombard-launch-cashless-digital-health-solution.html Tue, 27 Jul 2021 17:20:00 +0530 SVAAS Wellness, a wholly-owned subsidiary of Dr Reddy’s Laboratories and ICICI Lombard General Insurance Company have announced a partnership for the pilot launch of a first-of-its-kind cashless outpatient offering in India.     The partnership marks the launch of Dr Reddy’s digital health solution ‘SVAAS’ and demonstrates ICICI Lombard’s deeper foray into the wellness space.   For Dr Reddy’s, it will bring together four key touchpoints in the journey of outpatient healthcare and wellness – doctor consultations, pathology laboratories and diagnostic services, pharmacies, and insurance – through various suitable collaborations.   For ICICI Lombard, it will enable it to offer its wellness solutions through its comprehensive ILTakeCare app to a larger set of health-conscious consumers.     The services will be provided in the cities of Hyderabad and Visakhapatnam. It will be scaled up to key metros and tier I cities in the coming months. As part of the pilot, these holistic offerings will be available through ICICI Lombard’s unique wellness and insurance-related app, ILTakeCare.    Users will benefit from cashless access to consultation. It offers options of in-person as well as remote tele/video consultations, home sample collections and medicine deliveries, digital health record management and a comprehensive support and fulfilment system.    ]]> <![CDATA[Emcure Pharma adds independent directors]]> https://biospectrumindia.com/news/95/19238/emcure-pharma-adds-independent-directors.html https://biospectrumindia.com/news/95/19238/emcure-pharma-adds-independent-directors.html Tue, 27 Jul 2021 17:00:00 +0530 Emcure Pharmaceuticals has recently added four independent directors with a wealth of knowledge and experience in various fields. The new additions include Dr Shailesh Ayyangar, Vijay Gokhale, Hitesh Jain and Dr Vidya Yeravdekar. Earlier this year, Berjis Desai had taken over the chairman of Emcure Board. The company has had a long-standing tradition of appointing a Chairman from amongst its independent directors since 1997.   The additions to the leadership team for Emcure Pharmaceuticals, reflect its commitment towards enriching its expertise and strengthening its operations for future growth. The new members’ collective strength across legal, pharma spectrum, policy developments and academics will provide additional thrust to Emcure’s growth trajectory.     Commenting on the appointments, Satish Mehta, MD and CEO, Emcure Pharmaceuticals said, “We are delighted to have highly accomplished industry stalwarts as part of our board. New members’ combined experience and wider perspective from their respective fields, will play an instrumental role in strengthening our strategic operations to grow in domestic and international markets. It is an exciting time for the organisation, and we look forward to achieving newer heights with our new members on board.”   Emcure’s Chairman and Independent Director, Desai has been associated with Emcure Pharmaceuticals for over three decades. Dr Ayyangar appointed as Additional Director comes with an extensive experience of 34 years in healthcare and pharmaceutical. Gokhale appointed as Independent Director was in the Indian Foreign Service since 1981. Jain, appointed as Independent Director, is an alumnus of London School of Economics in 1996 and Dr Vidya Yeravdekar appointed as Independent Director is the Principal Director of Symbiosis Society, and the Pro-Chancellor of Symbiosis International University.      ]]> <![CDATA[Morepen Labs' net revenue up 50 per cent to Rs 388.31 Cr in Q1 FY’22]]> https://biospectrumindia.com/news/95/19236/morepen-labs-net-revenue-up-50-per-cent-to-rs-388-31-cr-in-q1-fy22.html https://biospectrumindia.com/news/95/19236/morepen-labs-net-revenue-up-50-per-cent-to-rs-388-31-cr-in-q1-fy22.html Tue, 27 Jul 2021 12:55:00 +0530 Morepen Laboratories has registered a growth of 97 per cent in its consolidated profits (before tax) at Rs 38.53 crore during the quarter ending June 30, 2021.  Profit after tax (PAT) for the quarter is up by 57 per cent at Rs 30.47 crores. The quarterly revenues of the company at Rs 388.31 crores have recorded an incredible growth of 50 per cent during the current quarter which highest ever growth in a quarter. In the Q1 FY’21, the company recorded quarterly revenues of Rs 258.97 crore. The company continued to control the operating costs resulting in an increase in Q1 FY’22 EBIDTA by 63 per cent at Rs. 45.43 crore whereas Cash Profit at Rs. 45.22 crore is up by 64 per cent. Sushil Suri, MD and Chairman stated, “Our partnership with RDIF to manufacture Sputnik vaccine in India is a big milestone for the company. We can manufacture up to 250 million doses per annum that can be ramped up to 500 million doses per annum. We remain committed to fighting the battle of Covid and gear ourselves for the fast vaccination of the nation. Morepen’s commitment towards this project is a step forward towards entry into biosimilars and other biologicals.”Domestic business of the company recorded a spectacular growth of 95 per cent in its Q1 FY’22 revenues at Rs 275.84 crore on the strength of huge growth contributed by domestic revenues of Diagnostics Devices and API business of the company.API business registered a handsome revenue growth of 17 per cent in the Q1 FY’22 on strength of the increase in Sales revenues of Loratadine and Montelukast. Loratadine exports for the quarter grew by 26 per cent while Montelukast has doubled its sales in the domestic market. The point of Care (POC) Medical Devices business has registered a growth of 189 per cent growth which is the highest ever in the quarter. The share of medical devices business on standalone basis has gone up from 26.1 to 36.9 per cent for this quarter as compared to last year same quarter. Blood glucose meters had a growth of 234 per cent growth at Rs 84.90 crores. BP Monitors Sales have jumped 183 per cent at Rs 20.76 crores. The finished dosage business has shown a significant recovery as compared to the same quarter last year and grew at Rs 39.90 crores registering a revenue growth of 30 per cent. ]]> <![CDATA[Biocon Biologics expands COVID-19 portfolio with addition of novel antibody]]> https://biospectrumindia.com/news/95/19232/biocon-biologics-expands-covid-19-portfolio-with-addition-of-novel-antibody.html https://biospectrumindia.com/news/95/19232/biocon-biologics-expands-covid-19-portfolio-with-addition-of-novel-antibody.html Mon, 26 Jul 2021 19:05:00 +0530 Biocon Biologics has announced that the US-based Adagio Therapeutics has granted an exclusive license to Biocon Biologics to manufacture and commercialise an antibody treatment based on ADG20 for India and select emerging markets.  ADG20, a novel monoclonal antibody targeting the spike protein of SARS-CoV-2 and related coronaviruses, is in global clinical development by Adagio as a single agent for both the treatment and prevention of COVID-19, the disease caused by the SARS-CoV-2 virus, its variants, as well as future variants that may emerge.  Initial data indicate that ADG20, Adagio’s lead clinical development candidate, could provide both rapid and durable protection against COVID-19 for up to one year. This could make it an ideal agent to prevent infections and significantly reduce COVID-19 related hospitalisations and death.  With its potential to address resistant variants, including the Delta variant, and its ability to be administered easily as a single, intramuscular injection in the outpatient setting, ADG20 is uniquely poised to address the current need for an effective, safe and convenient therapy for COVID-19.   Adagio plans to seek Emergency Use Authorization (EUA) in the US as early as the first quarter of 2022. Under the terms of the deal, Biocon Biologics will get access to the clinical and non-clinical data from Adagio’s EUA submission to the US Food and Drug Administration to seek approvals in the emerging markets.   ]]> <![CDATA[Alembic Pharma's Q1FY22 net profit down 45 per cent at Rs 165 Cr ]]> https://biospectrumindia.com/news/95/19231/alembic-pharmas-q1fy22-net-profit-down-45-per-cent-at-rs-165-cr-.html https://biospectrumindia.com/news/95/19231/alembic-pharmas-q1fy22-net-profit-down-45-per-cent-at-rs-165-cr-.html Mon, 26 Jul 2021 17:55:00 +0530 Alembic Pharmaceuticals has reported its consolidated financial results for the quarter ending June 30, 2021. In Q1 FY22, the company's net sales was down 1 per cent at Rs 1326 crores, the profit before tax was down 46 per cent at Rs 199 crores and the net profit was down 45 per cent at Rs 165 crores.Pranav Amin, MD, Alembic Pharmaceuticals said, "The India business grew exceptionally well and outpaced the industry. We hope to see this momentum continuing due to the initiatives undertaken recently. The US business faced price erosion due to increased competition. However, our long-term view of the US market remains intact."In the international business, the US Generics de-grew 38 per cent to Rs 369 crores in the quarter, the ex-US international formulations grew 13 per cent to Rs 197 crores in the quarter. Seven ANDA approvals were received during the quarter and the cumulative ANDA approvals was at 146 (including 18 tentative). Three ANDA filings happened during the quarter with cumulative ANDA filings at 212.The India branded business for the quarter grew by 57 per cent to Rs 481 crores. The acute segment, as well as the speciality segment, grew faster than the represented pharmaceutical market. ]]> <![CDATA[BDR Pharma signs license agreement with DRDO for COVID-19 drug 2-DG]]> https://biospectrumindia.com/news/95/19228/bdr-pharma-signs-license-agreement-with-drdo-for-covid-19-drug-2-dg.html https://biospectrumindia.com/news/95/19228/bdr-pharma-signs-license-agreement-with-drdo-for-covid-19-drug-2-dg.html Mon, 26 Jul 2021 11:50:00 +0530 BDR Pharma, based in Mumbai, has received approval and signed a license agreement with the Defence Research and Development Establishment (DRDE) and the Institute of Nuclear Medicine and Allied Sciences (INMAS) of the Defence Research and Development Organisation (DRDO) for the manufacturing, distribution, and marketing of 2- Deoxy-D-Glucose (2-DG) in India.   Last month, the Drugs Controller General of India (DCGI) approved the oral medication for emergency usage as adjuvant therapy in mild to severe COVID-19 patients.   2-DG was discovered to speed up the recovery of COVID-19 patients in hospitals and to lessen the need for supplementary oxygen in COVID-19 patients.   Commenting on the development Dharmesh Shah, CMD, BDR Pharmaceuticals, expressed, "This arrangement aims to ensure that this drug reaches as many eligible Indian patients as possible who are suffering from the devastating pandemic. We aim to ramp up the availability of successful treatment and coordinate manufacturing so that there is no scarcity of drugs to give to people fighting the disease. We expect that by widening and deepening the identification and development of COVID-19 therapy options, this collaboration can address more unmet medical needs."    BDR has applied to the Drug Controller General of India (DCGI) for restricted emergency use authorization to manufacture Drug 2-DG to treat COVID-19 patients in India. For the development of 2-DG drugs, the DRDO has recently signed agreements with four major Indian generic medicine producers. ]]> <![CDATA[Sun Pharma signs agreement with Cassiopea for acne drug in US and Canada]]> https://biospectrumindia.com/news/95/19226/sun-pharma-signs-agreement-with-cassiopea-for-acne-drug-in-us-and-canada.html https://biospectrumindia.com/news/95/19226/sun-pharma-signs-agreement-with-cassiopea-for-acne-drug-in-us-and-canada.html Mon, 26 Jul 2021 10:55:00 +0530 Sun Pharmaceutical Industries and Cassiopea, a speciality pharmaceutical company developing and preparing to commercialise prescription drugs with novel mechanisms of action (MOA) to address long-standing essential dermatological conditions announced the signing of License and Supply Agreements for Winlevi (clascoterone cream 1 per cent) in the US and Canada. Winlevi has been approved by the United States Food & Drug Administration (FDA) as a novel drug with a unique mechanism of action for the topical treatment of acne in patients 12 years and older.   Under the terms of the above-referred agreements, Sun Pharma will have the exclusive right to commercialise Winlevi in the US and Canada, and Cassiopea will be the exclusive supplier of the product. Cassiopea will receive an upfront payment of $45 million, potential commercial milestones totalling up to $190 million and customary double-digit royalties. The agreements will close upon the expiration of the HSR waiting period.    Winlevi is expected to be available in the US in the Q4 of 2021.   Abhay Gandhi, CEO, North America, Sun Pharma, said, "Sun Pharma is pleased to enter into a collaboration with Cassiopea. Winlevi is a new class of topical medication in dermatology and will complement our existing oral acne portfolio. The addition of Winlevi further strengthens our position in the acne segment and reinforces our deep commitment to caring and making a difference in the lives of patients."   Diana Harbort, CEO, Cassiopea, commented, “We are pleased to partner with Sun Pharma. Sun Pharma has a strong established US dermatology presence and will make Winlevi widely available to dermatology health care providers and their patients. Following this transaction, Cassiopea will be expecting substantial revenue streams for the foreseeable future and will be well funded to continue the development of its innovative dermatology pipeline.”   The FDA approved Winlevi (clascoterone cream 1 per cent) in August 2020 for the topical treatment of acne vulgaris in patients 12 years and older.    ]]> <![CDATA[Jubilant Pharma posts Rs 1,635 Cr revenue in Q1’FY22]]> https://biospectrumindia.com/news/95/19220/jubilant-pharma-posts-rs-1635-cr-revenue-in-q1fy22.html https://biospectrumindia.com/news/95/19220/jubilant-pharma-posts-rs-1635-cr-revenue-in-q1fy22.html Fri, 23 Jul 2021 18:30:00 +0530 Jubilant Pharma has posted its Q1FY22 results. In the quarter, the consolidated revenue was Rs 1,635 crore versus Rs 1,156 crore in Q1'FY21. The total EBITDA was at Rs 379 crore versus Rs 183 Crore in Q1’FY21. Finance costs have been reported at Rs 35 crore versus Rs 48 crore in Q1'FY21. The average blended interest rate for Q1'FY22 stood at 4.64 per cent versus 5.26 per cent in Q1’FY21. Profit after tax was at Rs 160 crore as compared to Rs 35 crore in Q1'FY21. EPS was at Rs 10.1 versus Rs 2.2 in Q1'FY21. The capital expenditure for the quarter was at Rs 106 crore.Commenting on company’s performance, Shyam S Bhartia, Chairman and Hari S Bhartia, Co-Chairman and MD, Jubilant Pharmova said, "During this quarter, in addition to YoY increase, we also reported sequential improvement in the speciality pharma segment with gradual recovery across radiopharmaceuticals, radiopharmacy and allergy business. In radiopharmaceuticals, we have enhanced efforts to promote existing products as well as expand our product pipeline with strategic partnerships. With a gradual recovery in nuclear medicine procedures, the turnaround plan of the radiopharmacy business is on track. CMO business continued to benefit from COVID related deals. Contract Research and Development Services business witnessed strong YoY growth in revenues led by healthy demand from customers. We have doubled our chemistry research capacity and the facility is operational now. Despite COVID-19 related lockdowns, we have been able to ensure continuity in most of our manufacturing operations across all business segments while at the same time ensuring the safety of our employees." ]]> <![CDATA[Wockhardt posts revenue growth of 36 per cent in Q1FY 22]]> https://biospectrumindia.com/news/95/19210/wockhardt-posts-revenue-growth-of-36-per-cent-in-q1fy-22.html https://biospectrumindia.com/news/95/19210/wockhardt-posts-revenue-growth-of-36-per-cent-in-q1fy-22.html Thu, 22 Jul 2021 18:20:00 +0530 Wockhardt has posted its first-quarter result for the financial year 2021-22. The company has recorded substantial revenue growth (up by 36 per cent over the previous quarter and 32 per cent over the previous corresponding quarter) and in EBITDA at Rs 108 crore compared to a loss of Rs 49 crore in the corresponding quarter of the previous year. Profit after Tax (PAT) for the quarter was Rs 13 crore against Rs 93 crore in the previous quarter. Net Debt-Equity ratio as of June 30, 2021, stood at 0.55 (March 31, 2021, stood at 0.54). During the quarter ended June 30, 2021, the UK business grew by 86 per cent over the previous corresponding quarter and stood at Rs 407 crore in Q1FY22 (PY Rs 218 crore).  The UK business contributed about 47 per cent of the global revenue. Major growth has come from the COVID-19 vaccine business.  The continuing India business stood at Rs 152 in Q1FY22 (PY Rs 62 crore) registering a growth of 144 per cent. The total India business (Continued and Discontinued Operations) stood at Rs 152 crore in Q1FY22 as compared to Rs 116 crore in Q1FY21 – a growth of 31 per cent. India business contributed 18 per cent of the global revenue.  The emerging markets business of the company stood at Rs 124 crore in Q1FY22 (PY Rs 139 crore). The emerging markets business contributed about 14 per cent of the global revenue.  The Irish business stood at Rs 36 crore in Q1FY22 (PY Rs 33 crore). The US business stood at Rs 102 crore in Q1FY22 as compared to Rs 114 crore in Q1FY21. In the US, the business contributed 12 per cent of the global revenue. Research and development expenditure during the quarter was at Rs 34 crore (4 per cent to sales) and including capital expenditure was at 8.5 per cent to sales. Capital expenditure during the quarter was Rs 40 crore. ]]> <![CDATA[Intas Pharma inks new global biosimilar agreement]]> https://biospectrumindia.com/news/95/19214/intas-pharma-inks-new-global-biosimilar-agreement.html https://biospectrumindia.com/news/95/19214/intas-pharma-inks-new-global-biosimilar-agreement.html Thu, 22 Jul 2021 08:00:00 +0530 Ahmedabad-based Intas Pharmaceuticals continues to pledge their commitment to increasing access to high quality medicines by entering into an exclusive license agreement with Japan-based Meiji and South Korean firm Dong-A Socio Holdings (a parent company of Dong-A ST) to commercialize DMB-3115, a proposed biosimilar to ustekinumab, a recombinant monoclonal antibody for the treatment of autoimmune and inflammatory diseases such as plaque psoriasis, Crohn's disease and ulcerative colitis. Under the terms of the agreement, Intas have been granted exclusive license rights to commercialize DMB-3115 worldwide, excluding Japan, Korea and certain countries in Asia. Meiji and Dong-A ST will develop and manufacture DMB-3115 and supply the product to Intas and its worldwide affiliates. This is yet another industry first for Intas, one of the leaders in the development and commercialization of biosimilar products, who are the first Indian company to launch a biosimilar product in the EU. "We are truly excited by this partnership, which brings together the development expertise of Meiji and Dong-A ST with the extensive commercial reach of Intas," said Vice Chairman, Binish Chudgar." ]]> <![CDATA[GeneStore bags 'Best Investment in France' laurel]]> https://biospectrumindia.com/news/95/19201/genestore-bags-best-investment-in-france-laurel.html https://biospectrumindia.com/news/95/19201/genestore-bags-best-investment-in-france-laurel.html Wed, 21 Jul 2021 17:30:00 +0530 Genestore was recently awarded the 'Best Investment in France' laurel by the Business France department of the French Embassy in India at the Indo-France awards held in New Delhi. The announcement was made at an award ceremony in New Delhi in the presence of his excellency Emmanuel Lenain, the French ambassador to India and Eric Fajole, Trade Commissioner - Embassy of France.    The recognition boosts the scope of Indo-French business ties, wherein the Indian-origin diagnostics company, GeneStore has been critical in bringing about a market correction in terms of affordability of COVID-19 RT-PCR kits manufacturing and testing to both the Indian and French markets by undertaking a joint technology development and local manufacturing programme in both countries.    "This recognition heralds a new growth era in the Indian biotech sector where mid-sized Indian corporates are expanding globally and enhancing their access to technology and manufacturing know-how," added Anubhav Anusha, Global CEO, GeneStore.    GeneStore is now investing over 10 million euros (Rs 80 crores) over the next 18 months across enhancing research and manufacturing capabilities in France, India, Latin America, and Africa to work towards managing and eradicating infectious diseases globally. Furthermore, GeneStore is also investing in a biotech and healthcare technology incubator in India to provide Indian research talent with the framework to develop strong business models and access the global market. ]]> <![CDATA[Syngene posts PAT of Rs 773 M in Q1 results]]> https://biospectrumindia.com/news/95/19198/syngene-posts-pat-of-rs-773-m-in-q1-results.html https://biospectrumindia.com/news/95/19198/syngene-posts-pat-of-rs-773-m-in-q1-results.html Wed, 21 Jul 2021 10:30:00 +0530 Syngene International announced its first-quarter results for FY22. The company reported quarterly revenue from operations growth of 41 per cent year-on-year to Rs 5,945 million; profit after tax for the quarter increased by 33 per cent year-on-year to Rs 773 million.    Jonathan Hunt, MD and CEO, Syngene International, said, "We made a strong start to the financial year. Besides continuing progress across all our business divisions, growth for the quarter was strongly boosted by the manufacturing of COVID-19 treatment, Remdesivir, as we increased production to meet the needs of the second wave of COVID-19 in India. We also made headway with the expansion of our dedicated R&D centre for Bristol Myers Squibb following the contract extension announced last quarter. As India faced a second wave of the pandemic, our safety protocols continued to provide a sustainable work environment enabling our staff to operate at normal levels and keep client projects on track. During the quarter, following government guidance, we were proud to be able to offer vaccinations to our staff and their families as an additional level of protection. Overall, first-quarter performance was in line with our expectations and puts us on track to meet our full-year growth guidance in the coming quarters."  ]]> <![CDATA[LifeCell Diagnostics launches comprehensive preeclampsia screening ]]> https://biospectrumindia.com/news/95/19196/lifecell-diagnostics-launches-comprehensive-preeclampsia-screening-.html https://biospectrumindia.com/news/95/19196/lifecell-diagnostics-launches-comprehensive-preeclampsia-screening-.html Tue, 20 Jul 2021 17:15:00 +0530 Chennai-based diagnostic service provider LifeCell is offering screening for both early-onset and late-onset preeclampsia during pregnancy. The addition of sFLT-1 (soluble FMS-like tyrosine kinase-1) in the screening panel will enable the prediction of preeclampsia and help in accurate diagnosis even in the third trimester.    Preeclampsia, a serious complication of pregnancy, affects 8-10 per cent of Indian women and is characterised by high blood pressure that can damage major organs.    LifeCell’s comprehensively designed preeclampsia screening tests adhere to protocols defined by the Fetal Medicine Foundation and the National Institute for Health and Care Excellence (NICE).   Additionally, the tests provide reliable results based on the biochemical markers along with ultrasound findings and the mother’s medical history. The early-onset preeclampsia screening test is performed along with combined first-trimester screening (CFTS) to evaluate the levels of PIGF (Placenta growth factor)  in the mother’s blood.   As the ASPRE trial demonstrated, the early detection of preeclampsia using CFTS can be managed with the administration of low-dose aspirin in high-risk women, reducing the risk of preterm preeclampsia by more than 60 per cent.    Additionally, LifeCell's late-onset preeclampsia screening evaluates a different biomarker, sFlt-1. In women who develop pre-eclampsia, the levels of sFlt-1 are thought to be higher than those seen in normal pregnancy. The screening for late-onset preeclampsia, thus, measures the sFlt-1 and PlGF ratio which effectively allows identification of low-risk pregnancies that are at a high risk of developing preeclampsia.      ]]> <![CDATA[Novo Nordisk Education Foundation launches diabetes chatbot Mishti ]]> https://biospectrumindia.com/news/95/19184/novo-nordisk-education-foundation-launches-diabetes-chatbot-mishti-.html https://biospectrumindia.com/news/95/19184/novo-nordisk-education-foundation-launches-diabetes-chatbot-mishti-.html Mon, 19 Jul 2021 12:00:00 +0530 Novo Nordisk Education Foundation (NNEF) has launched a WhatsApp Chatbot, Mishti as a one-stop solution for diabetes education in India. NNEF’s Mishti aims to provide easy and quick access to important information to effectively manage diabetes.     Some of the key information services offered by Mishti include insulin device demos, customised diet plans for each patient with exercise guidance based on publicly available information, and scientifically backed research papers. It is customised in seven different languages (English, Hindi, Bengali, Gujarati, Marathi, Punjabi, and Tamil) so that a greater number of people can access the information in their preferred language.     "Mishti is our effort to empower the 77 million people living with diabetes[2] to make informed decisions with scientifically backed information. We are committed to addressing the challenges of diabetes  management in India by continuing to drive change’’ says Vikrant Shrotriya, Managing Trustee, Novo Nordisk Education Foundation.     Mishti delivers diabetes-centric information to the country’s massive diabetes population at their fingertips through Whatsapp. A large number of diabetes patients are unable to manage their disease well due to limited awareness, poor medication adherence, and improper lifestyle and dietary habit. Through Mishti, NNEF aims to cater to India’s diabetes education needs and resolve these problems.  ]]> <![CDATA[Aragen Life Sciences partners with Skyhawk Therapeutics]]> https://biospectrumindia.com/news/95/19167/aragen-life-sciences-partners-with-skyhawk-therapeutics.html https://biospectrumindia.com/news/95/19167/aragen-life-sciences-partners-with-skyhawk-therapeutics.html Thu, 15 Jul 2021 14:50:00 +0530 Aragen Life Sciences (formerly, GVK BIO), a leading Contract Research and Development Organization (CRDO), headquartered out of Hyderabad,  has been selected by US-based Skyhawk Therapeutics, a leader in the development of small molecule therapeutics that correct RNA expression, as its partner in India. Through this collaboration, Aragen will provide Skyhawk with various discovery chemistry and biology service solutions. This partnership is focused on accelerating Skyhawk’s research pipeline.“We are delighted to have been selected by Skyhawk Therapeutics as its partner in India. At Aragen, we believe that in every molecule is the possibility for better health. It is with this spirit that we look forward to leveraging Aragen’s 20 years of discovery research expertise to help Skyhawk advance the development of its novel small molecule therapeutics targeting some of the world’s most intractable diseases.”, said Manni Kantipudi, CEO, Aragen. ]]> <![CDATA[Altem Tech partners with Cellink to accelerate 3D bioprinting]]> https://biospectrumindia.com/news/95/19159/altem-tech-partners-with-cellink-to-accelerate-3d-bioprinting.html https://biospectrumindia.com/news/95/19159/altem-tech-partners-with-cellink-to-accelerate-3d-bioprinting.html Wed, 14 Jul 2021 15:50:00 +0530 Bengaluru-based Altem Technologies, the provider of 3D printing solutions, has partnered with US-based CELLINK, a bioink company, to accelerate life-science research with 3D Bioprinting in the Indian market. With this partnership, Altem intends to establish a strong presence of bioprinting in the field of medical research and life science applications.    The partnership with Altem enables Cellink to expand its footprint in the Indian market, providing bioprinting knowhow to researchers to conduct in-vitro studies and reduce the product development time of drugs and medicines.    Sharath Chandra, Co-founding Director, Altem Technologies, said, “Through this partnership, we invest in making strategic efforts in identifying and nurturing the 3DBioprinting development opportunities for India. The outcome of this partnership will be to engage and respond to future trends of medicine and healthcare with bio convergence solutions”.   Cecilia Edebo, CEO/ MD, CELLINK Bioprinting said, “The convergence of robotics-AI-genomics-bioprinting can contribute to improved quality and future of healthcare. Given the larger addressable population and growing demands for precision medicine, there is a pressing need for addressing the healthcare requirements on priority and calls for accelerated research on the future of healthcare. Our Partnership with Altem will contribute in the direction of developing the technology of tomorrow for creating a better quality of life.” ]]> <![CDATA[Lupin launches Tavaborole topical solution in US market]]> https://biospectrumindia.com/news/95/19151/lupin-launches-tavaborole-topical-solution-in-us-market.html https://biospectrumindia.com/news/95/19151/lupin-launches-tavaborole-topical-solution-in-us-market.html Tue, 13 Jul 2021 16:55:00 +0530 Lupin announced the US launch of Tavaborole Topical Solution, 5 per cent having received approval from the United States Food and Drug Administration (FDA). The product will be manufactured at Lupin’s facility in Pithampur. Tavaborole Topical Solution, 5 per cent, is the generic equivalent of Kerydin Topical Solution, 5 per cent, of Anacor Pharmaceuticals, and is an oxaborole antifungal indicated for the topical treatment of onychomycosis of the toenails due to Trichophyton rubrum or Trichophyton mentagrophytes. Tavaborole Topical Solution (RLD: Kerydin), 5 per cent has an estimated annual sales of $53 million in the US. ]]> <![CDATA[RDIF partners with Serum Institute of India for Sputnik vaccine production]]> https://biospectrumindia.com/news/95/19150/rdif-partners-with-serum-institute-of-india-for-sputnik-vaccine-production.html https://biospectrumindia.com/news/95/19150/rdif-partners-with-serum-institute-of-india-for-sputnik-vaccine-production.html Tue, 13 Jul 2021 13:40:00 +0530 The Russian Direct Investment Fund (RDIF, Russia’s sovereign wealth fund) and Serum Institute of India (SII) have announced cooperation to produce the Russian Sputnik vaccine against coronavirus.   The first batch of Sputnik vaccines is expected to be produced at SII’s facilities in September. The parties intend to produce over 300 million doses of the vaccine in India per year.    As part of the technology transfer process, SII has already received cell and vector samples from the Gamaleya Center. With their import approved by the Drug Controller General of India (DCGI), the cultivation process has begun.   Adar Poonawalla, CEO, SII, said, "I am delighted to partner with RDIF to manufacture the Sputnik vaccine. We hope to make millions of doses in the coming months with trial batches starting in September. With high efficacy and a good safety profile, the Sputnik vaccine must be accessible in full measure for people across India and the world. Given the uncertainty of the virus, it is important for international institutes, and governments to collaborate and further bolster up our fight against the pandemic.”   Kirill Dmitriev, CEO, Russian Direct Investment Fund, commented, “RDIF is delighted to cooperate with Serum Institute of India, the world’s largest vaccine manufacturer. This strategic partnership is a major step to substantially increase our production capabilities demonstrating a perfect example of joining forces and expertise to save lives both in India and around the world. With technology transfer underway we expect the first batches of the vaccine to be produced jointly with SII in coming months.”  ]]> <![CDATA[MediCircle Health launches SpectraLIT in India market]]> https://biospectrumindia.com/news/95/19141/medicircle-health-launches-spectralit-in-india-market.html https://biospectrumindia.com/news/95/19141/medicircle-health-launches-spectralit-in-india-market.html Mon, 12 Jul 2021 17:40:00 +0530 MediCircle Health, an AI-powered diagnostics company, is introducing the SpectraLIT - Spectral Instant Test in India. SpectraLIT is a portable spectrophotometry-based testing platform that is powered by machine learning and artificial intelligence to detect COVID-19 by using an individual’s nasal or mouthwash sample. This eliminates the need for complex lab equipment and chemicals by providing immediate results using the spectral signature of the virus. The AI algorithm enables SpectraLIT to distinguish between an infected person and a healthy person. Additionally, the algorithm can be adjusted to detect different variants of the SARS-CoV-2 coronavirus.    SpectraLIT is developed by Newsight Imaging which specialises in developing advanced machine vision chip sensors in collaboration with the reputed Sheba Medical Center’s ARC Innovation Center in Israel. The technology is licensed to Hong Kong-based AI Innobio for the Asia-Pacific region. MediCircle Health has an exclusive tie-up with AIInnoBio to launch the test in India.   Eventually, SpectraLIT will be able to test for diseases other than COVID-19. The platform will grow and innovations will allow it to detect other infectious diseases such as influenza, tuberculosis, malaria, dengue, and UTIs, as well as non-communicable diseases such as sickle cell disease.   SpectraLIT has received the European Union CE-IVD mark of authorization for use in the diagnosis of COVID-19, which is recognised and accepted in India by ICMR. It has been launched in seven countries and has been approved by ICTS, the European airport security giant to offer a quick COVID-19 screening process at European airports. It has also been tested in 36 hospitals across North and Latin America, Asia Pacific, Europe, and the Middle East. SpectraLIT is currently undergoing FDA approvals in the US.   ]]> <![CDATA[Emcure Pharma appoints Naveen Soni as Director – Corp Comm, public relations]]> https://biospectrumindia.com/news/95/19139/emcure-pharma-appoints-naveen-soni-as-director-corp-comm-public-relations.html https://biospectrumindia.com/news/95/19139/emcure-pharma-appoints-naveen-soni-as-director-corp-comm-public-relations.html Mon, 12 Jul 2021 15:25:00 +0530 Emcure Pharmaceuticals has appointed Naveen Soni as Director – Corporate Communications & Public Relations. His responsibilities include overseeing communications for Emcure Pharmaceuticals. Soni comes with over two decades of multi-sector experience in corporate communications, strategic business advocacy, marketing and business journalism. Formerly, Soni has also held communication portfolios in leadership positions with leading Indian MNCs such as UPL, Welspun Group, Wadia Group, Hubtown, and PUG India wherein he was responsible for driving strategic communications and crafting internal and external stakeholder engagement programmes. Before foraying into the corporate side, he has been an award-winning anchor-Journalist with India’s leading business channels including CNBC TV18 and Zee Business. During his media stint, he was responsible for planning, conceptualising and hosting popular shows on stock markets and personal finance.Commenting on the appointment, Satish Mehta, MD and CEO, Emcure Pharmaceuticals said, “I am delighted to welcome Soni to the team and look forward to working with him as he heads our communication strategy. We are pleased to have a veteran like Naveen on board with us.”Sharing his comments on the appointment, Soni said, “It’s a great opportunity to be working with Emcure Pharmaceuticals and I am truly excited to take on this role. I look forward to working with the passionate and foresighted leadership.”Soni will be working closely with the management at Emcure Pharmaceuticals. ]]> <![CDATA[Schneider Electric, Kewaunee International to create next-gen laboratories ]]> https://biospectrumindia.com/news/95/19136/schneider-electric-kewaunee-international-to-create-next-gen-laboratories-.html https://biospectrumindia.com/news/95/19136/schneider-electric-kewaunee-international-to-create-next-gen-laboratories-.html Mon, 12 Jul 2021 14:45:00 +0530 Schneider Electric has announced a strategic alliance with US-based Kewaunee Scientific Corporation’s International Division. The alliance will embolden Schneider Electric’s advancements in digital transformation and the integration of new-age technologies in the life sciences, healthcare, diagnostic and other segments requiring top-performing laboratories.   Schneider Electric and Kewaunee International will commence their operations to traverse across the complete lifecycle of laboratories from design, build, operation, and maintenance to allow the effective management of smart labs throughout their entire lifecycle.   The collaboration will further streamline data analytics, monitoring and laboratory management to create secure networks and mitigate risks to bolster business function.   The company’s IoT and cloud-enabled EcoStruxure solution will render increased efficiency leading towards a well-equipped and future-ready ecosystem within laboratories. These labs will be powered by cutting-edge technologies that increase productivity and performance by omitting redundancies and breaking down silos.     “Smart labs of the future will catalyse our vision to provide real-time insights across people, products and processes by end-to-end lifecycle management in labs. We are proud to enter into this alliance, as we envision a future where our technical expertise and Kewaunee International’s prowess in manufacturing and infrastructure will render all-encompassing smart labs to create a more sustainable ecosystem for our customers,” says Manish Kumar SVP, Digital Buildings, Schneider Electric.      ]]> <![CDATA[ENTOD Pharma to expand in medical cosmetics, ophthalmic surgical segments]]> https://biospectrumindia.com/news/95/19130/entod-pharma-to-expand-in-medical-cosmetics-ophthalmic-surgical-segments.html https://biospectrumindia.com/news/95/19130/entod-pharma-to-expand-in-medical-cosmetics-ophthalmic-surgical-segments.html Mon, 12 Jul 2021 10:05:00 +0530 ENTOD Pharmaceuticals plans to foray into the medical cosmetics and ophthalmic surgical segments. The company which recently celebrated its 44th Foundation Day on July 11, plans to add 100 employees to its workforce each month until September 2021.    The company has ventured into the market of medical cosmetics through a joint-venture with NuSkin London. NuSkin London is a research initiative of ENTOD Research Cell UK Ltd, to improve skin formulation research and create innovative dermatological solutions. The joint venture is expected to help commercialise NuSkin London’s skincare and medical cosmetic innovations across the Indian sub-continent and international markets like Malaysia, Philippines, Hong Kong, Singapore and others. The company also plans to expand in the ophthalmic surgical segment by launching its HyTek Division, which will deal with surgical products.    With innovative and research-driven ophthalmic and ENT products, ENTOD has been facilitating rapid advances in the segment. The phenocaine plus intracameral mydriatic injection helps to achieve rapid and stable pupillary dilatation without using preoperative dilating eye drops and sustained intraocular anaesthesia for pain-free surgery and better surgical outcomes. The research team has come up with an innovative micronised ocular suspension technology that offers better formulation stability, greater bioavailability, more precise dosing and reduced ocular irritation. The company has introduced NOVELIA preservative-free eye drop technology by tying up with a pharmaceutical giant, NEMERA (France).     Speaking about the latest development and expansion plans, Nikkhil K Masurkar, Executive Director, ENTOD, said “Over the next two to three years, we are also planning to venture into the surgical products sector that would further enable us to establish our presence across the domestic and international markets.”   The company was founded in 1977 by GV Masurkar, a pharmacist and a visionary. The company with more than 1000 employees has its footprints across more than 55 countries around the world. With over Rs 150-crore revenue in FY21, the company has seen a growth of 30-40 per cent from last year even during the COVID pandemic. ]]> <![CDATA[Alembic Pharma gets US FDA approval for cancer drug]]> https://biospectrumindia.com/news/95/19123/alembic-pharma-gets-us-fda-approval-for-cancer-drug.html https://biospectrumindia.com/news/95/19123/alembic-pharma-gets-us-fda-approval-for-cancer-drug.html Fri, 09 Jul 2021 13:15:00 +0530 Alembic Pharmaceuticals has received final approval from the US Food & Drug Administration (US FDA) for its Abbreviated New Drug Application (ANDA) for Erlotinib tablets, 25 mg, 100 mg, and 150 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Tarceva Tablets, 25 mg, 100 mg, and 150 mg, of OSI Pharmaceuticals, LLC.    Erlotinib tablets are indicated for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) whose tumours have epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitution mutations as detected by an FDA-approved test receiving first-line, maintenance, or second or greater line treatment after progression following at least one prior chemotherapy regimen. Erlotinib tablet in combination with gemcitabine is indicated for the first-line treatment of patients with locally advanced, unresectable or metastatic pancreatic cancer.   Erlotinib Tablets, 25 mg, 100 mg, and 150 mg, have an estimated market size of $37 million for twelve months ending March 2021 according to IQVIA.   Alembic has a cumulative total of 148 ANDA approvals (130 final approvals and 18 tentative approvals) from US FDA.   ]]> <![CDATA[Rubicon Research buys Cipla's Meditab Specialities' Satara facility]]> https://biospectrumindia.com/news/95/19124/rubicon-research-buys-ciplas-meditab-specialities-satara-facility.html https://biospectrumindia.com/news/95/19124/rubicon-research-buys-ciplas-meditab-specialities-satara-facility.html Fri, 09 Jul 2021 00:00:00 +0530 Mumbai-based pharma company Rubicon Research has announced the acquisition of Meditab Specialities' oral liquid dosage and nasal product manufacturing facility located in Satara, Maharashtra. Meditab Specialities is a wholly-owned subsidiary of Cipla.   The Satara facility is a state-of-the-art cGMP compliant and MHRA (UK) inspected production site that enables a strong and diverse pipeline of oral liquids for Rubicon Research. The company will seek additional regulatory approvals at the Satara site, including from the US FDA.     “The acquisition of an outstanding oral liquid and nasal inhalers manufacturing facility advances our plan to offer a wider portfolio to our customers. These capabilities combined with our R&D expertise strengthens our ability to offer best-in-class drug products across dosage forms, which will benefit patients around the world. On behalf of Rubicon Research, I welcome our new colleagues and am confident that together we can continue to grow and make Rubicon Research one of the top 10 specialty generic pharmaceutical companies in the world,” said Parag Sancheti, CEO, Rubicon Research.   ]]> <![CDATA[Mankind Pharma gets DRDO nod to manufacture, market COVID-19 drug 2-DG]]> https://biospectrumindia.com/news/95/19116/mankind-pharma-gets-drdo-nod-to-manufacture-market-covid-19-drug-2-dg.html https://biospectrumindia.com/news/95/19116/mankind-pharma-gets-drdo-nod-to-manufacture-market-covid-19-drug-2-dg.html Thu, 08 Jul 2021 17:45:00 +0530 New Delhi-based Mankind Pharma has received the license to manufacture and market the oral 2-deoxy-D-glucose for the treatment of COVID-19 from the Defence Research and Development Organisation (DRDO). 2-DG was developed by the Defence Research and Development Establishment (DRDE), Gwalior and the clinical trials were conducted by the Institute of Nuclear Medicine and Allied Sciences (INMAS), a lab of DRDO in association with Dr Reddy’s Laboratory.Mankind Pharma will absorb the technology and manufacture the product at its manufacturing facilities located at Visakhapatnam and Himachal Pradesh. 2-DG is found to help the hospitalised COVID-19 patients recover faster and it is also known to reduce the supplemental oxygen dependency among the COVID-19 patients. The drug comes in powder form in a sachet, which can be taken orally by dissolving it in water. It accumulates in the virus-infected cells and prevents virus growth by stopping viral synthesis and energy production. Its selective accumulation in virally infected cells makes this drug unique. In clinical trials, the patients treated with 2-DG showed faster symptomatic cure than Standard of Care (SoC) on various endpoints.   ]]> <![CDATA[Sanofi, GSK to conduct Ph 3 trial of COVID-19 vaccine in India]]> https://biospectrumindia.com/news/95/19114/sanofi-gsk-to-conduct-ph-3-trial-of-covid-19-vaccine-in-india.html https://biospectrumindia.com/news/95/19114/sanofi-gsk-to-conduct-ph-3-trial-of-covid-19-vaccine-in-india.html Thu, 08 Jul 2021 14:45:00 +0530 Sanofi and GSK have received approval for their Phase 3 clinical study in India, to assess the safety, efficacy and immunogenicity of their adjuvanted recombinant-protein COVID-19 vaccine candidate.   The global, randomised, double-blind Phase 3 study will include more than 35,000 volunteers aged 18 and older across sites in the US, Asia, Africa, and Latin America.   As COVID-19 vaccination becomes available, study participants are encouraged to receive an approved COVID-19 vaccine during the study, if they wish to do so. As part of the study design, all participants including the control group will be offered the study vaccine as soon as it is determined to be safe and effective.   Annapurna Das, Country Head, Sanofi Pasteur India said, "India is participating in Sanofi Pasteur’s pivotal Phase 3 study, and subject to subsequent approvals, we should soon begin enrollment of study participants in the country. As the virus continues to evolve, we are anticipating what will be needed in the coming months and years, and accordingly, have adapted our vaccine development programme. We believe our COVID-19 adjuvanted, recombinant vaccine can make a significant contribution to the ongoing fight against COVID-19 and are committed to initiating our clinical programme in India, at the earliest.” ]]> <![CDATA[Alembic Pharma receives US FDA approval for depression drugs]]> https://biospectrumindia.com/news/95/19112/alembic-pharma-receives-us-fda-approval-for-depression-drugs.html https://biospectrumindia.com/news/95/19112/alembic-pharma-receives-us-fda-approval-for-depression-drugs.html Thu, 08 Jul 2021 11:30:00 +0530 Alembic Pharmaceuticals has received final approval from the US Food & Drug Administration (US FDA) for its Abbreviated New Drug Application (ANDA) for Desipramine Hydrochloride tablets USP, 10 mg, 25 mg, 50 mg, 75 mg, 100 mg, and 150 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Norpramin Tablets, 10 mg, 25 mg, 50 mg, 75 mg, 100 mg, and 150 mg, of Validus Pharmaceuticals LLC. Desipramine Hydrochloride Tablets, USP are indicated for the treatment of depression.   Desipramine Hydrochloride tablets USP, 10 mg, 25 mg, 50 mg, 75 mg, 100 mg, and 150 mg have an estimated market size of $ 7 million for twelve months ending March 2021 according to IQVIA.   Alembic has a cumulative total of 147 ANDA approvals (129 final approvals and 18 tentative approvals) from US FDA. ]]> <![CDATA[RDIF, Morepen Labs produce test batch of Sputnik V vaccine in India]]> https://biospectrumindia.com/news/95/19097/rdif-morepen-labs-produce-test-batch-of-sputnik-v-vaccine-in-india.html https://biospectrumindia.com/news/95/19097/rdif-morepen-labs-produce-test-batch-of-sputnik-v-vaccine-in-india.html Tue, 06 Jul 2021 15:05:00 +0530 The Russian Direct Investment Fund (RDIF, Russia’s sovereign wealth fund) and New Delhi-based Morepen Laboratories, have announced the production of the test batch of the Russian Sputnik V coronavirus vaccine in an exclusive facility in Himachal Pradesh. The first batch will be shipped to the Gamaleya Center for quality control.   RDIF and Morepen Labs signed a cooperation agreement in June 2021 and are actively implementing the technology transfer aiming to produce 850 million doses of Sputnik V in India per year sufficient to vaccinate 250 million people.   Kirill Dmitriev, CEO, Russian Direct Investment Fund, commented, “As the pandemic is yet far from over and new, more dangerous variants of coronavirus are being detected in various regions of the world, RDIF is increasing capacities for the production of Sputnik V in India, one of the key hubs. Agreement with Morepen Laboratories provides for a larger amount of Sputnik V to be available both for India and our partners globally to speed up the vaccination with one of the best vaccines in the world.”   Sushil Suri, CMD, Morepen Laboratories, said, “We are delighted to partner with RDIF for the prestigious project of Sputnik V production in India. This would be our privilege to work jointly on expanding the production base in India. We take this partnership as a starting point for a long term relationship with RDIF and its partner companies as we look forward to many more areas of common interest. Morepen’s commitment towards this project is a step forward towards entry into biosimilars and other biologicals.”     ]]> <![CDATA[Mankind Pharma partners with Ace Turtle]]> https://biospectrumindia.com/news/95/19093/mankind-pharma-partners-with-ace-turtle.html https://biospectrumindia.com/news/95/19093/mankind-pharma-partners-with-ace-turtle.html Mon, 05 Jul 2021 17:55:00 +0530 Mankind Pharma has partnered with Ace Turtle, a leading omnichannel platform company to accelerate its omnichannel transformation in India. Ace Turtle will enable Mankind Pharma with a unified commerce platform that supports various omnichannel use cases and drive seamless customer experience at scale across digital channels.   Powered by machine learning, Ace Turtle’s unified commerce platform, Rubicon 3.0 supports various omnichannel use cases such as inventory lying anywhere that can be sold across channels, fulfilling orders from any stock points (retail stores, warehouses, and distributors) and a single view of product, inventory, and customer through a single platform.   Speaking on the partnership, Joy Chatterjee, General Manager, Mankind Pharma said, “We are happy to partner with Ace Turtle as their highly scalable solution will play a critical role in accelerating our omnichannel strategy."   Speaking on the partnership, Nitin Chhabra, CEO, Ace Turtle said, “We are confident that our omnichannel platform Rubicon will improve Mankind Pharma’s business performance and build flexibility against future disruptions."   ]]> <![CDATA[Panacea Biotec receives manufacturing license from DCGI for Sputnik V vaccine]]> https://biospectrumindia.com/news/95/19086/panacea-biotec-receives-manufacturing-license-from-dcgi-for-sputnik-v-vaccine.html https://biospectrumindia.com/news/95/19086/panacea-biotec-receives-manufacturing-license-from-dcgi-for-sputnik-v-vaccine.html Mon, 05 Jul 2021 00:00:00 +0530 New Delhi-based Panacea Biotec has announced receipt of manufacturing license from Drugs Controller General (India) for Sputnik V vaccine against COVID-19 pursuant to its collaboration with Russian Direct Investment Fund (Russia’s sovereign wealth fund). The license is a necessary condition for using Sputnik V produced by Panacea Biotec in India. The batches produced at Panacea Biotec’s facilities at Baddi, Himachal Pradesh were earlier shipped to the Gamaleya Center in Russia for quality control. The said batches have successfully passed all the checks for quality parameters both at the Gamaleya Center in Russia and at the Central Drug Laboratory, Kasauli, Himachal Pradesh in India. There are no strong allergies caused by Sputnik V. The storage temperature of Sputnik V at +2-8 degrees means it can be stored in a conventional refrigerator without any need to invest in additional cold-chain infrastructure. The price of Sputnik V is less than $10 per shot, making it affordable around the world. ]]> <![CDATA[COVAXIN demonstrates overall efficacy of 77.8% in ph 3 clinical trial]]> https://biospectrumindia.com/news/95/19082/covaxin-demonstrates-overall-efficacy-of-77-8-in-ph-3-clinical-trial.html https://biospectrumindia.com/news/95/19082/covaxin-demonstrates-overall-efficacy-of-77-8-in-ph-3-clinical-trial.html Sat, 03 Jul 2021 00:00:00 +0530 Bharat Biotech has announced the safety and efficacy analysis data from Phase III clinical trials of COVAXIN®, a whole virion inactivated vaccine against SARS-CoV2, was developed in partnership with ICMR and NIV Pune.  Phase 3 clinical trials of COVAXIN® was an event driven analysis of 130 symptomatic COVID-19 cases, reported at least two weeks after the 2nd dose, conducted at 25 sites across India. The vaccine is formulated with a novel Algel+IMDG adjuvant. IMDG is a TLR7/8 agonist known to induce memory T cell responses along with strong neutralizing antibodies. The activation of cell mediated immune responses is especially valuable in a multi epitope vaccine such as COVAXIN®, where immune protection can be achieved from S, RBD and N proteins alike. IMDG was developed under partnership between Virovax and NIAID, National Institutes of Health USA. The safety profile of COVAXIN® is now well established based on inactivated vaccines technology, and in large part due to the extensive 20-year safety track record of Bharat Biotech’s vero cell manufacturing platform. Furthermore, Bharat Biotech has so far not sought indemnity for COVAXIN® from the Governments.        No licensed SARS-CoV-2 vaccine has reported efficacy against asymptomatic infection in a randomised controlled trial, based on qPCR testing. COVAXIN® is the first to report promising efficacy against asymptomatic infections based on qPCR testing that will help in reducing disease transmission.  COVAXIN® has now received emergency use authorizations in 16 countries including, Brazil, India, Philippines, Iran, Mexico, etc. with EUA’s in process in 50 countries worldwide. The company is in discussions with WHO to obtain emergency Use Listing.   Bharat Biotech has established COVAXIN® manufacturing at 4 facilities within India, further expansions are in process to reach an annualized capacity of 1 billion doses by the end of 2021. Technology transfer activities are in progress to companies in United States, and other countries.  ]]> <![CDATA[Laurus Labs bags DRDO licence to develop and market covid drug]]> https://biospectrumindia.com/news/95/19080/laurus-labs-bags-drdo-licence-to-develop-and-market-covid-drug.html https://biospectrumindia.com/news/95/19080/laurus-labs-bags-drdo-licence-to-develop-and-market-covid-drug.html Fri, 02 Jul 2021 15:50:00 +0530 Laurus Labs has received a licence from Defence Research & Development Organisation (DRDO) to manufacture and market 2- Deoxy-D-Glucose (2DG). 2DG has been given emergency approval by the Drug Controller General of India (DCGI) for use on COVID-19 patients in the country. Laurus Labs has already applied with CDSCO for emergency use authorisation (EUA) for 2DG. ]]> <![CDATA[Alembic Pharma bags US FDA approval for urinary tract infection drug]]> https://biospectrumindia.com/news/95/19067/alembic-pharma-bags-us-fda-approval-for-urinary-tract-infection-drug.html https://biospectrumindia.com/news/95/19067/alembic-pharma-bags-us-fda-approval-for-urinary-tract-infection-drug.html Fri, 02 Jul 2021 14:50:00 +0530 Alembic Pharmaceuticals has received final approval from the US Food & Drug Administration (US FDA) for its Abbreviated New Drug Application (ANDA) for Nitrofurantoin Capsules, USP (Macrocrystals), 25 mg, 50 mg and 100 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Macrodantin Capsules, 25 mg, 50 mg, and 100 mg, of Alvogen Malta Operations. Nitrofurantoin capsules, USP (Macrocrystals) is specifically indicated for the treatment of urinary tract infections when due to susceptible strains of Escherichia coli, enterococci, Staphylococcus aureus, and certain susceptible strains of Klebsiella and Enterobacter species.   Nitrofurantoin Capsules, USP (Macrocrystals), 25 mg, 50 mg and 100 mg have an estimated market size of $23 million for twelve months ending March 2021 according to IQVIA.   Alembic has a cumulative total of 146 ANDA approvals (128 final approvals and 18 tentative approvals) from the US FDA.   ]]> <![CDATA[Lupin gets US FDA nod for SOLOSEC to treat trichomoniasis]]> https://biospectrumindia.com/news/95/19074/lupin-gets-us-fda-nod-for-solosec-to-treat-trichomoniasis.html https://biospectrumindia.com/news/95/19074/lupin-gets-us-fda-nod-for-solosec-to-treat-trichomoniasis.html Thu, 01 Jul 2021 20:05:00 +0530 Lupin Pharmaceuticals, the US-based wholly-owned subsidiary of global pharma major Lupin, announced that the US Food and Drug Administration (FDA) has approved the company’s supplemental New Drug Application (sNDA) to expand the use of SOLOSEC (secnidazole) to include the treatment of trichomoniasis in adults.    Trichomoniasis vaginalis is the most common non-viral, curable sexually transmitted infection (STI) in the US, affecting an estimated three to five million people every year. SOLOSEC was approved in the US in 2017 for the treatment of bacterial vaginosis (BV) in adult women. The supplemental approval makes SOLOSEC the first and only single-dose oral prescription antimicrobial agent approved for the treatment of both trichomoniasis and BV.    “The FDA’s approval for the additional indication for SOLOSEC to treat trichomoniasis builds upon our commitment to support women’s health and provides health care professionals with an option to treat patients with trichomoniasis and bacterial vaginosis (BV). Research demonstrates that approximately 70 per cent of women with trichomoniasis are PCR positive for BV,” said Jon Stelzmiller, President – Specialty, Lupin Pharmaceuticals.    SOLOSEC is now available for both treatments of patients and their partners. The FDA approval of SOLOSEC for the treatment of trichomoniasis in men was granted based on four open-label trials in males; one comparative study with metronidazole and ornidazole in males only and three single-arm studies in males and females.11 Parasitological evaluation was performed both pre-and post-treatment and reported cure rates ranging from 91.7 per cent (165/180) to 100 per cent (30/30) at time points ranging from two to 20 days (n=437, 211 males and 226 females). ]]> <![CDATA[Zydus applies to DCGI for EUA to launch Plasmid DNA vaccine for COVID-19]]> https://biospectrumindia.com/news/95/19071/zydus-applies-to-dcgi-for-eua-to-launch-plasmid-dna-vaccine-for-covid-19.html https://biospectrumindia.com/news/95/19071/zydus-applies-to-dcgi-for-eua-to-launch-plasmid-dna-vaccine-for-covid-19.html Thu, 01 Jul 2021 17:00:00 +0530 Ahmedabad-based Zydus Cadila has announced that the company has applied for Emergency Use Authorization (EUA) to the office of Drug Controller General of India (DCGI) for ZyCoV-D - its Plasmid DNA Vaccine against COVID-19. The company conducted the largest clinical trial for its COVID-19 vaccine in India so far in over 50 centers. This was also the first time that any COVID-19 vaccine has been tested in adolescent population in the 12-18 years age group in India. Around 1000 subjects were enrolled in this age group and the vaccine was found to be safe and very well tolerated. The tolerability profile was similar to that seen in the adult population. Primary efficacy of 66.6% has been attained for symptomatic RT-PCR positive cases in the interim analysis. Whereas, no moderate case of COVID-19 disease was observed in the vaccine arm post administration of the third dose suggesting 100% efficacy for moderate disease. No severe cases or deaths due to COVID-19 occurred in the vaccine arm after administration of the second dose of the vaccine. ZyCoV-D had already exhibited a robust immunogenicity and tolerability and safety profile in the adaptive Phase I/II clinical trials carried out earlier. Both the Phase I/II and Phase III clinical trials have been monitored by an independent Data Safety Monitoring Board (DSMB). The plug and play technology on which the plasmid DNA platform is based is ideally suited for dealing with COVID-19 as it can be easily adapted to deal with mutations in the virus, such as those already occurring. In another development, the Company has also evaluated a two dose regimen for ZyCoV-D vaccine using a 3 mg dose per visit and the immunogenicity results had been found to be equivalent to the current three dose regimen. This will further help in reducing the full course duration of vaccination while maintaining the high safety profile of the vaccine in the future ]]> <![CDATA[Axio Biosolutions bags FDA clearance for Axiostat Patch]]> https://biospectrumindia.com/news/95/19055/axio-biosolutions-bags-fda-clearance-for-axiostat-patch.html https://biospectrumindia.com/news/95/19055/axio-biosolutions-bags-fda-clearance-for-axiostat-patch.html Wed, 30 Jun 2021 12:40:00 +0530 Bengaluru-based Axio Biosolutions has announced FDA 510(k) clearance of its haemostatic product Axiostat Patch, which helps control moderate to severe bleeding in vascular procedures, surgical debridement sites, puncture sites and more.   Axiostat Hemostatic Patch is based on a protonated bioadhesive technology that works by providing a strong mechanical barrier to the injury site. It controls bleeding from puncture sites within minutes of application, providing a barrier to bacteria protection while reducing the ambulation time in patients significantly.    Axiostat had also received CE mark in Europe earlier and is approved in over 40 countries worldwide. Over half a million units have been deployed since inception globally especially on battlefields to control bleeding from trauma injuries.   Commenting on the latest development, Leo Mavely, Founder and CEO, Axio Biosolutions said, “This is a major milestone for us as the FDA clearance opens the door for us to enter markets such as cardio-vascular, haemodialysis and military bleeding control in the US. Axiostat is already a market leader for these in many countries and we intend to bring this technology to the US customers soon.”   ]]> <![CDATA[Takeda India introduces diagnostic programme for rare diseases]]> https://biospectrumindia.com/news/95/19054/takeda-india-introduces-diagnostic-programme-for-rare-diseases.html https://biospectrumindia.com/news/95/19054/takeda-india-introduces-diagnostic-programme-for-rare-diseases.html Wed, 30 Jun 2021 12:20:00 +0530 Takeda has announced ILLUMINATE - a rare disease diagnosis programme to support improved clinical results for patients with Lysosomal Storage Disorders (LSD), independently run and managed by PerkinElmer and sponsored by Baxalta Bioscience India (part of Takeda group of companies). The programme will support improved diagnostic pathways for patients with LSDs such as Gaucher disease, Fabry disease, and mucopolysaccharidosis Type II (MPSII; Hunter Syndrome).   Considerably reducing diagnostic time through the programme, physicians could timely initiate the therapy. Following initial recognition of symptoms that might indicate the diseases, Dried Blood Spot (DBS) testing enables physicians to confirm their diagnosis by taking a blood sample on a filter card and sending this to the laboratory for analysis. Reports are then available to the physicians, which can be accessed anytime on a password-based portal.   Simon Gallagher, Interim General Manager, Takeda India, said, “We are committed to bringing Better Health and a Brighter Future to people, including patients living with a rare disease with unmet medical needs. The programme will enable faster diagnosis, bridging infrastructure gaps to enable timely treatment and management of the disease."   In its first phase, the programme will be implemented by PerkinElmer at specific centres in Delhi, Haryana, Uttar Pradesh, Madhya Pradesh, Gujarat, Rajasthan, Maharashtra, West Bengal, Tamil Nadu, and Karnataka.   Sumedha Gupta, Head of Patient Services, Takeda India, said, “Over two years – we look at targeting diagnosis for ~10,000 patients through our partner PerkinElmer and subsequently improve the diagnostic rate, which is currently observed as less than 1 per cent." ]]> <![CDATA[Five pharma cos collaborate for clinical trial of Molnupiravir for COVID-19 treatment]]> https://biospectrumindia.com/news/95/19048/five-pharma-cos-collaborate-for-clinical-trial-of-molnupiravir-for-covid-19-treatment.html https://biospectrumindia.com/news/95/19048/five-pharma-cos-collaborate-for-clinical-trial-of-molnupiravir-for-covid-19-treatment.html Tue, 29 Jun 2021 17:40:00 +0530 Cipla, Dr Reddy’s, Emcure, Sun Pharma and Torrent will collaborate for the clinical trial of the investigational oral anti-viral drug Molnupiravir for the treatment of mild COVID-19 in an outpatient setting in India.     Between March and April this year, these five pharma companies had individually entered into a non-exclusive voluntary licensing agreement with Merck Sharpe Dohme (MSD) to manufacture and supply Molnupiravir to India and over 100 low and middle-income countries (LMICs).    The five pharma companies have entered into a collaboration agreement, wherein the parties will jointly sponsor, supervise and monitor the clinical trial in India. As per the directive of the Subject Expert Committee (SEC) of the Central Drugs Standard Control Organization, Dr Reddy’s will conduct the clinical trial using its product, and the other four pharma companies will be required to demonstrate equivalence of their product to the product used by Dr Reddy’s in its clinical trial.    Following the clinical trial protocol approval given by the Drugs Controller General of India, the clinical trial will be conducted for the treatment of mild COVID-19 in an outpatient setting. It is expected to take place between June and September this year across India with the recruitment of 1,200 patients. Such collaboration for a clinical trial is a first-of-its-kind within the Indian pharma industry and will aim to investigate yet another line of treatment in the collective fight against the COVID-19 pandemic. On successful completion of the clinical trial, each company will independently approach the regulatory authorities for approval to manufacture and supply Molnupiravir for the treatment of COVID-19 in India.   Molnupiravir is an oral antiviral that inhibits the replication of multiple RNA viruses including SARS-CoV-2. It is presently being studied by MSD, through a collaboration with Ridgeback Biotherapeutics, in a Phase III trial for the treatment of non-hospitalized patients with confirmed COVID-19 globally.    ]]> <![CDATA[B Medical Systems offers cold chain solutions to Dr Reddy’s for Sputnik V roll-out]]> https://biospectrumindia.com/news/95/19045/b-medical-systems-offers-cold-chain-solutions-to-dr-reddys-for-sputnik-v-roll-out.html https://biospectrumindia.com/news/95/19045/b-medical-systems-offers-cold-chain-solutions-to-dr-reddys-for-sputnik-v-roll-out.html Tue, 29 Jun 2021 17:00:00 +0530 B Medical Systems has partnered with Dr Reddy’s for providing reliable cold chain solutions for the pan India rollout of Sputnik V vaccines. Under this collaboration, B Medical Systems will install several hundreds of vaccine freezers across the country for the national roll-out of Sputnik V vaccines.   Under this collaboration, B Medical Systems will offer its vaccine freezers that provide a storage temperature as low as -25°C. The units were dispatched by air cargo from Luxembourg to meet the immediate requirements.   As a part of this collaboration, B Medical Systems’ freezers will be placed across all major hospital chains in the country this week. The vaccine freezers from B Medical Systems are WHO PQS certified and certified class I medical devices. The units have been used across the world and have proven their reliability even in extreme hostile weather conditions.   B Medical Systems recently started its India operations and is ramping up its production to meet the significant demand for its cold chain products including vaccine refrigerators and vaccine transport boxes. As a part of its India operations, B Medical Systems is also introducing flexible leasing models and various service packages.   “Our technology ensures that vaccines stored inside are not exposed to any temperature excursions and are maintained at their fullest efficacy. Our remote monitoring solutions ensure that there is end-to-end traceability of the storage conditions,’’ Jesal Doshi, CEO, B Medical Systems India. ]]> <![CDATA[Aragen expands discovery research agreement with Boehringer Ingelheim]]> https://biospectrumindia.com/news/95/19044/aragen-expands-discovery-research-agreement-with-boehringer-ingelheim.html https://biospectrumindia.com/news/95/19044/aragen-expands-discovery-research-agreement-with-boehringer-ingelheim.html Tue, 29 Jun 2021 13:00:00 +0530 Aragen Life Sciences (formerly GVK BIO), a leading Contract Research and Development Organization, headquartered out of Hyderabad, has announced an expansion of their discovery research agreement with Boehringer Ingelheim, with the goal of accelerating the discovery pipeline of Boehringer Ingelheim. This preferred partnership allows Boehringer Ingelheim, a leading research driven pharmaceutical company, to incorporate several design elements, synthesize, profile, and then characterize a wide range of chemotypes against key targets of interest in swift optimization cycles. The partnership also allows for the integrated up-scaling of compounds for larger pre-clinical studies. Biology screening of appropriate chemical moieties to drive decision making with speed and accuracy is also included in the partnership. Aragen will dedicate a sizeable portion of its campus in Hyderabad to support this alliance. ]]> <![CDATA[Lupin launches HIV drugs in US]]> https://biospectrumindia.com/news/95/19028/lupin-launches-hiv-drugs-in-us.html https://biospectrumindia.com/news/95/19028/lupin-launches-hiv-drugs-in-us.html Mon, 28 Jun 2021 10:50:00 +0530 Lupin announced the launch of Emtricitabine and Tenofovir Disoproxil Fumarate Tablets 200 mg/300 mg, having received approval from the United States Food and Drug Administration (FDA). Emtricitabine and Tenofovir Disoproxil Fumarate Tablets 200 mg/300 mg, are the generic equivalent of Truvada Tablets 200 mg/300 mg, of Gilead Sciences, Inc, and indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection.    It is also used for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection. Emtricitabine and Tenofovir Disoproxil Fumarate Tablets (RLD: Truvada) had estimated annual sales of $ 2.1 billion in the US (IQVIA MAT March 2021). ]]> <![CDATA[Dr Reddy's notifies commercial launch of 2-deoxy-D-glucose]]> https://biospectrumindia.com/news/95/19029/dr-reddys-notifies-commercial-launch-of-2-deoxy-d-glucose.html https://biospectrumindia.com/news/95/19029/dr-reddys-notifies-commercial-launch-of-2-deoxy-d-glucose.html Mon, 28 Jun 2021 08:00:00 +0530 Dr. Reddy’s Laboratories Ltd. has announced the commercial launch of 2-deoxy-D-glucose (2-DG). Dr. Reddy’s will supply to major Government as well as private hospitals across India. In the initial weeks, the Company will make the drug available in hospitals across metros and Tier 1 cities, and subsequently expand coverage to the rest of India. 2-DG manufactured by Dr. Reddy’s has a purity of 99.5% and is being sold commercially under the brand name 2DG. The maximum retail price (MRP) of each sachet has been fixed at Rs. 990, with a subsidized rate offered to Government institutions.  2-DG was developed by the Institute of Nuclear Medicine & Allied Sciences (INMAS), a laboratory of the Defence Research and Development Organisation (DRDO), in collaboration with Dr. Reddy’s. 2-DG is an oral drug. It can be administered only upon prescription and under the supervision of a qualified physician to hospitalised moderate to severe COVID-19 patients as an adjunct therapy to the existing standard of care. Emergency use approval for anti-COVID-19 therapeutic application of the drug was granted on May 1, 2021. Satish Reddy, Chairman, Dr. Reddy’s said: “2-DG is yet another addition to our COVID-19 portfolio that already covers the full spectrum of mild to moderate and severe conditions and includes a vaccine. We are extremely pleased to have partnered with DRDO in our collective fight against the COVID-19 pandemic.” ]]> <![CDATA[Mankind partners with BDR for distribution of COVID-19 drug Baricitinib ]]> https://biospectrumindia.com/news/95/19014/mankind-partners-with-bdr-for-distribution-of-covid-19-drug-baricitinib-.html https://biospectrumindia.com/news/95/19014/mankind-partners-with-bdr-for-distribution-of-covid-19-drug-baricitinib-.html Thu, 24 Jun 2021 17:00:00 +0530 Mankind Pharma partners with BDR Pharmaceuticals International for distributing the COVID-19 drug Baricitinib under the trademark BARIKIND that received restricted emergency use approval, for use in combination with remdesivir. According to the partnership, BDR Pharma will be manufacturing and marketing the product under a royalty free, limited and non-exclusive voluntary license from Eli Lilly and Company and Mankind Pharma will be distributing the same. Baricitinib received restricted emergency use approval, for use in combination with remdesivir, for treatment of suspected or laboratory confirmed coronavirus disease 2019 (COVID-19) in hospitalized adults, requiring supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). Lilly received permission for restricted emergency use from Central Drugs Standard Control Organization, a division of Ministry of Health. ]]> <![CDATA[PNB Vesper gets DCGI nod to conduct Ph III trials on COVID-19 drug]]> https://biospectrumindia.com/news/95/19010/pnb-vesper-gets-dcgi-nod-to-conduct-ph-iii-trials-on-covid-19-drug.html https://biospectrumindia.com/news/95/19010/pnb-vesper-gets-dcgi-nod-to-conduct-ph-iii-trials-on-covid-19-drug.html Thu, 24 Jun 2021 11:30:00 +0530 Kerala-based pharmaceutical organization PNB Vesper has received DCGI permission to conduct the final phase 3 clinical trials. After a detailed deliberation by the Subject Expert Committee (SEC) on the Phase 2 Clinical Trial results of PNB-001 (GPP-BALACOVIN), the company has now been given a green signal to conduct a nationwide multi-centred Phase 3 Clinical Trial on hospitalised COVID-19 patients with oxygen support.    The Phase 3 trial will be conducted on a large patient population in 12 hospitals all over India. GPP- BALACOVIN is a novel and safe drug that possesses significant efficacy to save the hospitalised patients with oxygen support, from the deadly coronavirus.    PN Balaram, CEO, PNB Vesper Life Sciences said, “We are happy that we have successfully developed a New Chemical Entity to treat COVID-19 and have received approval from DCGI to conduct the Phase 3 Clinical trials. This is a promising drug for COVID-19 patients around the world, who are hospitalised with oxygen support. The drug is explicitly non-toxic to humans as evidenced in Phase 1 and Phase 2 clinical trials. None of the patients treated with GPP- BALACOVIN reported any post-treatment health risks. There are about 28 post-covid long-term complications identified by WHO and our treated group does not pose any such long-term health risks and is feeling healthy compared to the standard arm."   Dr Eric Lattman, Vice President, PNB Vesper said, “The performance of GPP- BALACOVIN is much superior over the current treatment paradigm. The mechanism of action of the drug is unique and innovative. The parameters evaluated in the clinical trial indicates the potential of the drug in treating COVID-19 patients. The results of the clinical trial indicate that GPP- BALACOVIN was found to be a turbo anti-inflammatory molecule with immuno-modulation properties. This breakthrough feature of GPP- BALACOVIN can help in the treatment of several acute inflammatory and auto-immune diseases and cancer treatments in the future."   ]]> <![CDATA[US-based real estate firm accelerates health & wellness across India]]> https://biospectrumindia.com/news/95/19008/us-based-real-estate-firm-accelerates-health-wellness-across-india.html https://biospectrumindia.com/news/95/19008/us-based-real-estate-firm-accelerates-health-wellness-across-india.html Thu, 24 Jun 2021 00:00:00 +0530 Delos™, a wellness real estate and technology company based in US, and Propstack, Mumba-based real estate technology & data company, have announced a strategic collaboration to advance health and well-being in India. Through the collaboration, Propstack will accelerate awareness of Delos’ advanced air purification units to improve the quality of indoor environments across the country. The concentration of pollutants indoors can exceed those outdoors, with both short and long term health impacts. Delos’ advanced air purification system helps remediate air quality and pathogens, pollutant particles, expel odors and remove allergens. In response to the current pandemic, air purification systems have been considered by many to be a critical supplementary approach to reducing virus transmission rates by removing airborne pollutants and contaminants. Delos’ advanced air purification system is capable of capturing ultrafine particles and can reduce particles that carry airborne bacteria and viruses. “From more than eight years of experience and extensive research, we know that our indoor environments can play a significant role in safeguarding our health and well-being. We are proud to collaborate with Propstack to make our science-backed solutions more accessible in India and advance health and wellness across the country,” said Delos CEO and Founder Paul Scialla. ]]> <![CDATA[Cipla receives ANDA approval for COPD drug Brovana ]]> https://biospectrumindia.com/news/95/19000/cipla-receives-anda-approval-for-copd-drug-brovana-.html https://biospectrumindia.com/news/95/19000/cipla-receives-anda-approval-for-copd-drug-brovana-.html Wed, 23 Jun 2021 11:10:00 +0530 Cipla has received final approval for its Abbreviated New Drug Application (ANDA) for Arformoterol Tartrate Inhalation Solution 15 mcg / 2 mL from the United States Food and Drug Administration (US FDA).    Cipla’s Arformoterol Tartrate Inhalation Solution 15 mcg / 2 mL is an AN-rated generic therapeutic equivalent version of Sunovion Pharmaceuticals' Brovana.    Brovana is a long-acting beta-2 adrenergic agonist (beta-2 agonist) indicated for long-term, twice daily (morning and evening) administration in the maintenance treatment of bronchoconstriction in patients with chronic obstructive pulmonary disease (COPD), including chronic bronchitis and emphysema.   According to IQVIA (IMS Health), Brovana had US sales of approximately $438 M for the 12-month period ending April 2021. The product is available for shipping immediately. ]]> <![CDATA[Mankind Pharma unveils drug to treat diabetes, heart failure and CKD]]> https://biospectrumindia.com/news/95/18993/mankind-pharma-unveils-drug-to-treat-diabetes-heart-failure-and-ckd.html https://biospectrumindia.com/news/95/18993/mankind-pharma-unveils-drug-to-treat-diabetes-heart-failure-and-ckd.html Tue, 22 Jun 2021 17:25:00 +0530 Mankind Pharma has launched Justoza, a Dapagliflozin brand marketed by Mankind to treat diabetes, heart failure and chronic kidney disease (CKD).   The active pharmaceutical ingredient is procured from the DMF (Drug Master File) facility approved by US FDA, EU GMP and WHO GMP, which ensures the highest global efficacy and safety standards. It is believed that the quality of DMF grade facility product is of the highest standard in terms of safety and efficacy.   Speaking on the launch, Atish Majumdar, President, Mankind Pharma, said, “Launching API DMF Grade Dapagliflozin is an innovative futuristic approach to provide the best in class quality to the patients. This is just the beginning, we are committed to adding more medicines to the list. Serving life is a mission in progress for us at Mankind Pharma.” ]]> <![CDATA[Stratbeans introduces advanced sales enablement solution for pharma industry]]> https://biospectrumindia.com/news/95/18991/stratbeans-introduces-advanced-sales-enablement-solution-for-pharma-industry.html https://biospectrumindia.com/news/95/18991/stratbeans-introduces-advanced-sales-enablement-solution-for-pharma-industry.html Tue, 22 Jun 2021 15:20:00 +0530 Stratbeans, the provider of AI-based online learning solutions, has launched Atum Sales Plus, a new-age sales enablement solution powered by AI for the pharmaceuticals industry. The employment of Atum Sales Plus will equip the sales professionals in the pharma segment with better skills and technology, which would enhance their sales-readiness, leading to improved customer engagement and in turn, higher revenue generation.    The new sales enablement platform would allow faster onboarding of new sales team, provide remote coaching and practice opportunities, generate personalised training modules along with offering extensive AI-based performance support in the form of a reference library. All this would greatly enhance the efficiency of the sales personnel and enable them to deliver value-based selling experiences successfully.    Pradeip Agarwal, COO & Co-founder, Stratbeans, “Sales enablement is critical to ensure a healthy bottom line in these current unpredictable times. And, it is of utmost importance to give sellers the right technology in hand which could allow them to effectively spearhead sales and create maximum value and impact. Introduction of Atum Sales Plus is a milestone for us, and we look forward to making a valuable difference.”   Besides enhancing the selling skills and potential of the pharma field workforce, the employment of Atum Sales Plus would also enable the sales team to deliver tailor-made customer experiences and build compliant relationships, which is a key requirement of the industry.    Agarwal further adds, “At Stratbeans, innovation is our key mantra, and we are confident that the new sales enablement technology will empower sellers in the pharma segment to improve their operational efficiency, drive better sales and achieve maximum ROI.”   By providing up-to-date, real-time information on products and developments, the integration with Atum Sales Plus would also lead to a significant reduction of product launch times for the pharma companies.   ]]> <![CDATA[Sun Pharma, Celgene to resolve patent litigation for Generic Revlimid in US]]> https://biospectrumindia.com/news/95/18986/sun-pharma-celgene-to-resolve-patent-litigation-for-generic-revlimid-in-us.html https://biospectrumindia.com/news/95/18986/sun-pharma-celgene-to-resolve-patent-litigation-for-generic-revlimid-in-us.html Tue, 22 Jun 2021 10:35:00 +0530 Sun Pharmaceutical Industries along with one of its wholly-owned subsidiaries announced that they have reached an agreement with Celgene Corporation (Celgene), a wholly-owned subsidiary of Bristol Myers Squibb, to resolve the patent litigation regarding submission of an Abbreviated New Drug Application (ANDA) for a generic version of Revlimid (lenalidomide capsules) in the US.    According to the terms of the settlement, Celgene will grant Sun Pharma a license to Celgene’s patents required to manufacture and sell (subject to US FDA approval) certain limited quantity of generic lenalidomide capsules in the US beginning on a confidential date that is sometime after March 2022. In addition, the license will also allow Sun Pharma to manufacture and sell an unlimited quantity of generic lenalidomide capsules in the US beginning January 31, 2026.    As a result of the settlement, all Hatch-Waxman litigation between Sun Pharma and Celgene, regarding the Revlimid patents, will be dismissed. Additional details regarding the settlement are confidential. The agreement is subject to customary regulatory approvals. ]]> <![CDATA[Cadila Pharma launches Posaconazole for treatment of fungal diseases]]> https://biospectrumindia.com/news/95/18982/cadila-pharma-launches-posaconazole-for-treatment-of-fungal-diseases.html https://biospectrumindia.com/news/95/18982/cadila-pharma-launches-posaconazole-for-treatment-of-fungal-diseases.html Mon, 21 Jun 2021 18:15:00 +0530 Cadila Pharmaceuticals has launched a new triazole antifungal drug Posaconazole, which is effective against a wide range of invasive fungal diseases. The drug has also been recommended as a second-line treatment for Mucormycosis or black fungus as it is commonly known.   Posaconazole works by stopping the growth of fungi and has an excellent safety profile. Serious side effects are rare, even in the case of prolonged use.     “We have put in place the systems to ensure supply of the drug to hospitals on a priority basis. We aim to reach over 1,000 hospitals through our 4,000-strong distributor network in the next few weeks,” said OP Singh, President of Sales and Marketing, Cadila Pharmaceuticals..   Posaconazole is approved for prophylaxis against Aspergillus and Candida infections in immunocompromised patients at high risk for these infections and oropharyngeal candidiasis (OPC). The drug is presently available in suspension and tablet forms, while the injectable form is in the pipeline and is expected to be launched soon.   “Several studies have confirmed that compared with other azole antifungals, Posaconazole is much more effective against many Mucorales species that are responsible for the deadly Mucormycosis infection in COVID-19 patients. In addition to approved indications, posaconazole has been used with success as salvage therapy for invasive mould infections and endemic mycoses in patients who are refractory to or intolerant of other antifungal agents”, said Singh. ]]> <![CDATA[Centrient Pharma boosts statins API manufacturing capacity]]> https://biospectrumindia.com/news/95/18980/centrient-pharma-boosts-statins-api-manufacturing-capacity.html https://biospectrumindia.com/news/95/18980/centrient-pharma-boosts-statins-api-manufacturing-capacity.html Mon, 21 Jun 2021 16:45:00 +0530 Netherlands-based Centrient Pharmaceuticals (Centrient), has started production at its new statins manufacturing unit in Toansa site in Punjab. The company will double its statins production capacity at its recently built second dedicated site. This will enable Centrient to meet the growing demand for its sustainably manufactured Atorvastatin and Rosuvastatin Active Pharmaceutical Ingredients (APIs).   “With the doubling of our production capacity, we demonstrate our commitment to maintain our leadership position in line with our strategy and to continue supporting our customers’ business growth. Guided by our brand promise of quality, reliability, and sustainability, Centrient’s rosuvastatin and atorvastatin offer superior performance in all three areas to the benefit of our customers and the environment”, says Frans Vlaar, Chief Commercial Officer at Centrient.   Groundbreaking of the new manufacturing unit started at the end of 2019 and commercial supplies from the new unit will start in mid-2021. With the new manufacturing line being operational and doubling the production capacity, Centrient will be even better positioned to secure supply, meeting the growing demand from customers.    “We are proud that we have been able to complete this project in a timely way given the challenges of executing such a complex project amid the COVID pandemic,” says Jim McPherson, Chief Quality & Technical Operations Officer, Centrient. “It reinforces our absolute commitment to meet the expectations of our customers as a partner of choice - delivering reliable and secure supply using leading sustainable technologies. The facility incorporates design features that allow further improvements in GMP and energy utilisation, and enable greater automation for improved process control.”    ]]> <![CDATA[Bayer extends JV with Zydus for another three years ]]> https://biospectrumindia.com/news/95/18977/bayer-extends-jv-with-zydus-for-another-three-years-.html https://biospectrumindia.com/news/95/18977/bayer-extends-jv-with-zydus-for-another-three-years-.html Mon, 21 Jun 2021 13:55:00 +0530 Bayer (South East Asia) and Cadila Healthcare announced the extension of their joint venture (JV) by three years from June 2021. The companies first agreed on January 28, 2011, to set up the Joint Venture - Bayer Zydus Pharma Private for the sales and marketing of pharmaceutical products in India, with headquarters in Mumbai.    The JV company focussed on addressing the unmet healthcare needs of patients in India by providing best-in-class innovative health solutions. During the term of the joint venture, the company also launched some of Bayer’s global innovative assets like Xarelto, Eylea and Visanne in India. Bayer Zydus Pharma will continue to operate in core therapies including cardiovascular diseases, diabetes, women’s health, ophthalmology and oncology, with new products in the pipeline. Key products in the company’s pharmaceutical portfolio include Xarelto, Glucobay, EyleaTM, Yaz, Mirena and Visanne amongst others.    Manoj Saxena, MD, Bayer Zydus Pharma, said, “The JV with our trusted partner Zydus Cadila has been successful over the last decade in driving scalable reach of our health solutions to patients across the country. We endeavour to carry this momentum forward, harnessing the benefits of our partnership towards delivering innovation-led, patient-centric offerings and digital health tools in India. By sustaining the gains we have made over the years, we aim to fulfil unmet patient needs, strengthen the Indian healthcare ecosystem and translate our vision of ‘Health for All, Hunger for None’ into reality.”    Dr Sharvil Patel, MD, Cadila Healthcare, said, “We have always believed in the power of collaboration and working with partners to create win-win alliances which unlock value for patients and the healthcare system at large. The spirit of partnership in this JV has all been about channelling the core strengths of both Zydus and Bayer for the benefit of the patients. By maximising the reach, enabling access to innovative products for the patients and leveraging expertise for better health outcomes, the JV has set a benchmark. Moving ahead, we see the efforts intensifying as we address a common goal of contributing to a robust and sustainable healthcare system in India.”  ]]> <![CDATA[FlexiLoans.com partners with Retailio]]> https://biospectrumindia.com/news/95/18972/flexiloans-com-partners-with-retailio.html https://biospectrumindia.com/news/95/18972/flexiloans-com-partners-with-retailio.html Mon, 21 Jun 2021 11:35:00 +0530 FlexiLoans.com has partnered with Retailio, a B2B healthcare marketplace to provide working capital loans to its 100,000+ retailers and distributors pan India. The partnership aims to fund over 15,000+ pharma retailers in the next 18 months. It will enable the pharmacies to cater to the increased demand for healthcare products and stock holding period by ensuring that funding for their working capital needs is taken care of digitally within 24- 48 hours of them applying for a loan.   The seamless lending integration with Retailio took less than two weeks given FlexiLoans.com’s robust plug and play architecture. The retailers on Retailio will benefit from FlexiLoans's Co-lending platform - BiFrost with access to a wide range of lenders and seamless digital on-boarding.   Since its inception in 2016,Flexiloans.com has disbursed more than Rs 1000 crores to more than 30,000+ customers across 1500+ cities across India. It receives over 100,000 applications per month, largely from Tier II, III and Tier IV cities in India. By the end of this year, it aims to hit an annualised disbursal run-rate of Rs 1000+ crores in a single year. ]]> <![CDATA[Siemens Healthineers India bags recognition from Great Place to Work Institute]]> https://biospectrumindia.com/news/95/18967/siemens-healthineers-india-bags-recognition-from-great-place-to-work-institute.html https://biospectrumindia.com/news/95/18967/siemens-healthineers-india-bags-recognition-from-great-place-to-work-institute.html Sat, 19 Jun 2021 16:10:00 +0530 Siemens Healthineers India has been recognised by the Great Place to Work Institute as one of India’s best workplaces in the healthcare sector, in their 2021 rankings and is identified among ‘India’s Top 100 Best Companies to Work For -2021’, in the largest workplace culture study in the country. Few factors affirming the trust of employees include creating an ecosystem of trust, high-performance culture and imbibing aspects of credibility, respect, fairness, pride and camaraderie among the employees.   'We Care’ is another initiative that revolves around the overall wellbeing and safety of people, especially during the COVID-19 pandemic. Right from vaccination support (including dependents), policy upgrades, establishing a war room with volunteers from the organization across India, learning and development to the mental wellbeing of people. Such people-centric initiatives ensure they feel cared for and supported by the organization during these challenging times.   “At Siemens Healthineers, we embrace and value diversity in viewpoints, backgrounds, experiences, expertise, and individual qualities by fostering a culture where employees can be themselves, embrace challenges and thereby achieve amazing results. Our flexible and dynamic environment encourages our teams to go beyond their comfort zone and grow. We all at Siemens Healthineers are passionate about shaping the future of healthcare so that medicine becomes more precise and affordable, value is at the heart of care delivery, patients are treated as consumers, and healthcare becomes digital”, said Vivek Kanade, MD, Siemens Healthcare.   “Innovation has been and will always be at the core of our company culture. The company will be investing Rs 1,300 crore over the next five years in an innovation hub in Bengaluru, India. The investment is part of Siemens Healthineers’ strategy 2025, in which India plays an important role as a growth market for the company. The innovation hub will be housed in a new state-of-the-art campus, with a plan to add up to 1,800 digital talents over the next ten years,” said Dileep Mangsuli, Executive Director, Siemens Healthcare. ]]> <![CDATA[Lupin receives US FDA approval for kidney ailment tabs ]]> https://biospectrumindia.com/news/95/18952/lupin-receives-us-fda-approval-for-kidney-ailment-tabs-.html https://biospectrumindia.com/news/95/18952/lupin-receives-us-fda-approval-for-kidney-ailment-tabs-.html Thu, 17 Jun 2021 14:55:00 +0530 Lupin has received approval for its Sevelamer Hydrochloride Tablets, 400 mg and 800 mg from the US FDA to market a generic equivalent of Renagel tablets, 400 mg and 800 mg, of Genzyme Corporation. The product will be manufactured at Lupin’s facility in NagpurSevelamer hydrochloride tablets are indicated for the control of serum phosphorus in patients with chronic kidney disease (CKD) on dialysis. Sevelamer Hydrochloride Tablets (RLD: Renagel) had estimated annual sales of $80 million in the US. ]]> <![CDATA[Sri Sri Tattva launches AYUSH-64 for covid treatment]]> https://biospectrumindia.com/news/95/18951/sri-sri-tattva-launches-ayush-64-for-covid-treatment.html https://biospectrumindia.com/news/95/18951/sri-sri-tattva-launches-ayush-64-for-covid-treatment.html Thu, 17 Jun 2021 14:45:00 +0530 Sri Sri Tattva has introduced the AYUSH-64 tablets, which is been recognised by the Ministry of Ayush for being effective in the treatment of mild to moderate COVID-19 patients. It has obtained technology transfer from National Research & Development Corporation and will manufacture and distribute it nationally and internationally.AYUSH-64 tablets were launched in the presence of Vaidya Rajesh Kotecha, Secretary, Ministry of Ayush, Arvind Varchaswi, MD, Sri Sri Tattva, Vaidya Devendra Triguna, President, All India Ayurveda Congress, Bhushan Patwardhan, Former Vice-Chairman, University Grants Commission (UGC), Dr N Srikanth, Director General, The Central Council for Research in Ayurvedic Sciences (CCRAS), Rajiv Vasudevan, Founder AyurVAID Hospitals and Vikas Chauhan, Co-founder, 1 mg.AYUSH-64 was repurposed after scientific evidence generated from seven clinical studies across India. It has been identified as a potential adjunct to standard care in the management of asymptomatic, mild and moderate COVID-19 to improve the clinical recovery and quality of life through robust clinical trials conducted in the country. The in-silico study done on AYUSH-64 showed that about 35 out of 36 of its Phyto-constituents have a high binding affinity against the COVID-19 virus.Varchaswi said, “We have entered into a strategic partnership with 1 mg, to reach out to more people in need.”Kotecha said, “AYUSH-64 is not an immunomodulator, it is a drug repurposed for the treatment of COVID-19. The ingredients have immunomodulatory effects, but the study is done for the use of AYUSH-64 as a treatment in COVID-19 as an add on or as stand-alone. Docking studies were carried out for AYUSH-64 at NIN, ICMR and IIT, BHU. Preclinical studies were also carried out at THSTI and DBT Institute.” ]]> <![CDATA[Venus Remedies wins legal battle against French firm over intravenous paracetamol patent]]> https://biospectrumindia.com/news/95/18950/venus-remedies-wins-legal-battle-against-french-firm-over-intravenous-paracetamol-patent.html https://biospectrumindia.com/news/95/18950/venus-remedies-wins-legal-battle-against-french-firm-over-intravenous-paracetamol-patent.html Thu, 17 Jun 2021 13:05:00 +0530 Venus Remedies won a 10-year long legal battle that challenged patent claimed by French pharmaceutical firm SCR Pharmatop for producing the intravenous paracetamol solution in India.   In a decision dated June 4, 2021, the Indian Patent Office decided in favour of Venus Remedies and upheld its decision for revocation of the Indian patent because the process lacked any inventive step that made it superior to other existing solutions.    Venus’ opposition was intended to remove any Indian patent hurdle in manufacturing intravenous paracetamol solution in India. As intravenous paracetamol plays a critical role in managing inflammation and fever, hence the revocation of this patent is an encouraging development for the healthcare sector in the country reeling under the current pandemic.   Sharing the development with the key stakeholders of the company, Saransh Chaudhary, President, Global Critical Care, Venus Remedies said, “We are committed to finding and developing the best solutions for global health challenges the biggest part of which is bridging the gap between people and robust healthcare facilities. Our endeavour here was to make sure that critical drugs such as intravenous paracetamol are available in our country to be manufactured generically and accessible at economical prices for the general public, particularly during these difficult times.”   VRL filed the post-grant opposition against the SCR Pharmatop’s intravenous paracetamol patent back in 2011 before Indian Patent Office on several grounds such as lack of novelty and lack of inventive steps, among others. During the case, Patent Office first revoked the patent in 2018 observing that the claims made by SCR Pharmatop are obvious to an ordinary person skilled in the art, however, the company moved their plea to Delhi High Court and Intellectual Property Appellate Board (IPAB).    IPAB directed the Patent Office to again hear the matter and after hearing and written submissions from both parties the Indian Patent Office gave its final decision on June 4, 2021, maintaining the revocation order of Patent no.238164, dated December 24 2018. ]]> <![CDATA[US-based Greenway Health opens office in Bengaluru]]> https://biospectrumindia.com/news/95/18946/us-based-greenway-health-opens-office-in-bengaluru.html https://biospectrumindia.com/news/95/18946/us-based-greenway-health-opens-office-in-bengaluru.html Thu, 17 Jun 2021 10:00:00 +0530 US-based Greenway Health, a leading health information technology services provider, has announced it has expanded its operations with a recently launched office in Bengaluru. The expansion follows a period of innovation for Greenway, a Vista Equity Partners portfolio company, and signifies the company's commitment to rapid product and software execution, revenue growth and client success. Throughout the last year, Greenway significantly adapted its approach to meet client needs in response to COVID-19 and the new healthcare environment, including new collaborations, the launch of new solutions and the appointment of new C-level executives to its leadership team. The opening of an office in Bengaluru will further the company's ability to deliver innovative, customizable health technology solutions and service to its clients. "Greenway is committed to improving lives through innovative solutions. This year we have doubled down on our commitment to client success as our top priority and further enhanced the overall client experience. This includes delivering high-quality products on a rapid timeline and enabling more frequent communications," said Pratap Sarker, president of Greenway Health. "Expanding our operations and workforce globally not only helps us further our mission, but ensures Greenway thrives in any environment so our clients can continue providing quality patient care – no matter the circumstances." At the start of 2021, Prasan Sathyamoorthy was hired as general manager of Greenway India, working alongside a seasoned leadership team with experience in setting up and scaling India Centers. ]]> <![CDATA[Alembic Pharma's JV Aleor Dermaceuticals bags US FDA approval for testosterone topical solution ]]> https://biospectrumindia.com/news/95/18935/alembic-pharmas-jv-aleor-dermaceuticals-bags-us-fda-approval-for-testosterone-topical-solution-.html https://biospectrumindia.com/news/95/18935/alembic-pharmas-jv-aleor-dermaceuticals-bags-us-fda-approval-for-testosterone-topical-solution-.html Wed, 16 Jun 2021 12:00:00 +0530 Alembic Pharmaceuticals announced that its joint venture Aleor Dermaceuticals (Aleor) has received final approval from the US Food & Drug Administration (US FDA) for its Abbreviated New Drug Application (ANDA) for Testosterone Topical Solution USP, 30 mg per pump actuation. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Axiron Topical Solution, 30 mg per pump actuation, of Eli Lilly and Company (Lilly).    Testosterone Topical Solution USP, 30 mg per pump actuation is indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone: Primary hypogonadism (congenital or acquired) and Hypogonadotropic hypogonadism (congenital or acquired).   Testosterone Topical Solution USP, 30 mg per pump actuation has an estimated market size of $21 million for twelve months ending March 2021 according to IQVIA. Alembic has a cumulative total of 145 ANDA approvals (127 final approvals and 18 tentative approvals) from US FDA. ]]> <![CDATA[Ocugen secures manufacturing partnership with Jubilant for Covaxin in US]]> https://biospectrumindia.com/news/95/18934/ocugen-secures-manufacturing-partnership-with-jubilant-for-covaxin-in-us.html https://biospectrumindia.com/news/95/18934/ocugen-secures-manufacturing-partnership-with-jubilant-for-covaxin-in-us.html Wed, 16 Jun 2021 05:05:00 +0530 Ocugen, Inc., a biopharmaceutical company focused on discovering, developing, and commercializing gene therapies to cure blindness diseases and developing a vaccine to save lives from COVID-19, has announced that it has selected Jubilant HollisterStier of Spokane, Washington as its manufacturing partner for COVAXIN to prepare for potential commercial manufacturing of COVAXIN for the US and Canadian markets. Jubilant HollisterStier, a part of Jubilant Pharma Limited, is an integrated contract manufacturer of sterile injectables, ophthalmics, otics, sterile and non-sterile topicals and liquids. “We are pleased to partner with Ocugen and support the ongoing fight against COVID-19. With two facilities in North America working to manufacture multiple COVID-19 vaccines and therapies, we remain committed to supporting efforts to eradicate this global pandemic,” stated Pramod Yadav, CEO Jubilant Pharma Limited. COVAXIN studies show potential effectiveness against three key variants of SARS-CoV-2. Scientists at the Indian Council of Medical Research (ICMR)-National Institute of Virology, using an in-vitro plaque reduction neutralization assay, have found that COVAXIN-vaccinated sera effectively neutralized the Brazil variant of SARS-CoV-2, B.1.128.2, the alpha variant, B.1.1.7, which was first identified in the United Kingdom, as well as the delta variant, B.1.617, which was first identified in India. These studies suggest that COVAXIN vaccination may be effective against multiple SARS-CoV-2 variants. ]]> <![CDATA[MoH&FW's virtual workshop on cGMP for Indian pharma industry held ]]> https://biospectrumindia.com/news/95/18924/mohfws-virtual-workshop-on-cgmp-for-indian-pharma-industry-held-.html https://biospectrumindia.com/news/95/18924/mohfws-virtual-workshop-on-cgmp-for-indian-pharma-industry-held-.html Tue, 15 Jun 2021 16:45:00 +0530 The third of a series of six virtual workshops on Current Good Manufacturing Practices to support the Indian pharmaceutical industry’s vision of providing world-class quality medical products was inaugurated by Dr Mandeep Bhandari, Joint Secretary, Ministry of Health & Family Welfare, Government of India. The third workshop has 125 participants from 40 pharma units.    Union Ministry of Health & Family Welfare (MoH&FW) collaborated with the World Health Organization (WHO), JSS Academy of Higher Education & Research at Mysuru (JSS AHER), and the Indian Pharmaceutical Alliance (IPA).    In his inaugural address, Dr Bhandari, MoH&FW said, “This initiative of establishing robust learning and training platform meets the critical need of enabling further up-gradation of the pharmaceutical sector for global standards of quality. This will have a far-reaching positive impact."   Welcoming the capacity-strengthening workshops, Dr VG Somani, Drug Controller General of India, said, “We are committed to the highest regulatory standards to ensure quality, safety and efficacy of medical products. It is our constant endeavour that our standards are at par with the best in the world.”    Speaking on the occasion, the WHO representatives from HQ, WHO Regional Office for South-East Asia, and WHO Country Office for India said, “It is for the first time anywhere in the world that we have attempted a programme like this. At the heart of these workshops is the underlying philosophy behind the current Good Manufacturing Practice (cGMP) - ensuring that products are consistently produced and controlled according to quality standards."   The genesis of these workshops is a survey of the pharma sector in India by WHO in 2014, which had recommended further strengthening of the cGMP with the support of WHO.    “The virtual workshops on cGMP is a key step in that direction, and we are delighted to partner in this path-breaking program,” said Sudarshan Jain, Secretary-General, Indian Pharmaceutical Alliance.   Shirish Belapure, Senior Technical Advisor, Indian Pharmaceutical Alliance, said, “IPA Quality forum has one prime objective of upgrading the quality of Indian pharma and these workshops meet the need. IPA fully supports this initiative.”   National and international experts, including from WHO (HQ, Regional Office for South-East Asia, Country Office for India) and leading industry voices came together to design a need-based workshop programme. This was followed by a successful pilot workshop on cGMP for pharmaceutical units in December 2020 on a unique and dedicated WHO-JSS AHER web portal.    “It is a privilege for us to have anchored this initiative. We are grateful to the health ministry, WHO and partners for the faith reposed in us,” said Dr Surinder Singh, Vice-Chancellor, JSS AHER. To ensure long-term impact, a mentor will be guiding the participants for an informed understanding and implementation of WHO cGMP, prequalification guidelines and other world-class quality standards. Importantly, the workshops are also contributing to the larger developmental agenda of health for all.    Dr B Suresh, Pro-Chancellor, JSS AHER said, “The workshops are an important step for enabling the enhancement of pharma standards and contributing to global agendas, including the 2030 Agenda for Sustainable Development. We are delighted to be part of this process.”   Under this initiative, a total of six workshops are being conducted - two for formulation manufacturing pharma units, three for active pharmaceutical ingredients (APIs) manufacturing units, and one for medical devices and IVD manufacturers. Cumulatively, over 650 plus participants from over 185 units will take part in this capacity-strengthening programme.    ]]> <![CDATA[Strides Pharma teams up with Ennaid Therapeutics to manufacture COVID-19 drug]]> https://biospectrumindia.com/news/95/18923/strides-pharma-teams-up-with-ennaid-therapeutics-to-manufacture-covid-19-drug.html https://biospectrumindia.com/news/95/18923/strides-pharma-teams-up-with-ennaid-therapeutics-to-manufacture-covid-19-drug.html Tue, 15 Jun 2021 15:15:00 +0530 Bengaluru-based Strides Pharma Science has announced that its step‐down wholly owned subsidiary, Strides Pharma Global Pte. Limited, Singapore has entered into an exclusive partnership with US-based Ennaid Therapeutics, a global pharmaceutical company to produce an oral, repurposed medication to treat mild, moderate and asymptomatic cases of COVID‐19.    Ennaid’s partnership with discovery scientists at Universidad Católica de Murcia (UCAM), identified a therapeutic target to treat COVID‐19 using artificial intelligence drug discovery platforms. Initial tests show antiviral activity effective against SARS CoV‐2, the virus that causes COVID‐19, by inhibiting 90% of the virus' replication in vitro studies. These results are so compelling that Ennaid is ready to seek emergency authorization from the FDA in the United States as well an approval for compassionate use in India. Strides will be the exclusive manufacturing partner to Ennaid for the product.   Dr R Ananthanarayanan, Managing Director and Group CEO, Strides, stated: “We are pleased to partner with Ennaid as an exclusive manufacturer of its oral repurposed medication to treat mild, moderate and asymptomatic cases of COVID‐19. At Strides we are committed in our fight against COVID‐19 and are working on creating a portfolio of products to aid COVID treatment and supportive care. Partnership with Ennaid is part of our initiative to provide quality and affordable treatment to the global patient pool impacted by COVID‐19.” ]]> <![CDATA[Lupin receives UK marketing authorisation for Luforbec]]> https://biospectrumindia.com/news/95/18914/lupin-receives-uk-marketing-authorisation-for-luforbec.html https://biospectrumindia.com/news/95/18914/lupin-receives-uk-marketing-authorisation-for-luforbec.html Mon, 14 Jun 2021 15:50:00 +0530 Luforbec 100/6 µg pMDI is indicated for regular treatment of asthma and the symptomatic treatment of patients with severe COPD   Lupin announced that its UK subsidiary, Lupin Healthcare (UK) has received approval from the Medicines and Healthcare products Regulatory Agency (MHRA) to market Luforbec (beclometasone dipropionate/formoterol fumarate dihydrate) 100/6 µg pressurised metered-dose inhaler (pMDI), the first branded generic of Fostair (beclometasone dipropionate/formoterol fumarate dihydrate) 100/6 µg pMDI, which has the potential to offer significant cost savings for the NHS.   Luforbec 100/6 µg pMDI is indicated for regular treatment of asthma and the symptomatic treatment of patients with severe chronic obstructive pulmonary disease (COPD) (FEV1 <50 per cent predicted normal).   “We are truly delighted to receive the first marketing authorisation for generic Fostair 100/6 µg pMDI in the UK. This is an important milestone for our respiratory franchise as we expand our product offering across the globe,” said Vinita Gupta, CEO, Lupin. “At Lupin, we remain committed to serving patients suffering from respiratory diseases with quality and cost-effective treatment.”   “The approval of Luforbec 100/6 µg pMDI is a pivotal milestone for the UK and a welcome step for Lupin as we draw on our strong expertise in inhalation research and development and expand our respiratory portfolio. We are proud to support healthcare providers and patients by continuing to invest in specialised treatments for chronic diseases,” said Thierry Volle, President - EMEA, Lupin. ]]> <![CDATA[KIMS Hospitals IPO to open on June 16, 2021]]> https://biospectrumindia.com/news/95/18900/kims-hospitals-ipo-to-open-on-june-16-2021.html https://biospectrumindia.com/news/95/18900/kims-hospitals-ipo-to-open-on-june-16-2021.html Fri, 11 Jun 2021 16:15:00 +0530 Krishna Institute of Medical Sciences (KIMS) Hospitals will open the Bid/Offer period to its initial public offering of equity shares on June 16, 2021 (the 'IPO'/ 'Offer'). The Bid / Offer Period will close on June 18, 2021. The price band of the offer has been fixed at Rs 815 to Rs 825 per equity share.The IPO comprises a fresh issue aggregating up to Rs 2,000 million (the 'Fresh Issue') and an offer for sale of up to 23,560,538 equity shares (the 'Offer for Sale'), up to 16,003,615 equity shares by General Atlantic Singapore (the 'Investor Selling Shareholder'), up to 387,966 equity shares by Dr Bhaskara Rao Bollineni, up to 775,933 equity shares by Rajyasri Bollineni, up to 387,966 equity shares by Bolllineni Ramanaiah Memorial Hospital (collectively, the 'Promoter Selling Shareholders'), up to 6,005,058 equity shares by persons referred to in Annexure A to the red herring prospectus dated June 9, 2021 (RHP) (the 'Other Selling Shareholders', and together with the 'Investor Selling Shareholder' and 'Promoter Selling Shareholders', the 'Selling Shareholders', and such equity shares, the 'Offered Shares'). The offer includes a reservation aggregating up to Rs 200 million for subscription by eligible employees of the company. Further, the offer include ]]> <![CDATA[Hyd-based Biophore applies for DCGI approval of Aviptadil]]> https://biospectrumindia.com/news/95/18891/hyd-based-biophore-applies-for-dcgi-approval-of-aviptadil.html https://biospectrumindia.com/news/95/18891/hyd-based-biophore-applies-for-dcgi-approval-of-aviptadil.html Fri, 11 Jun 2021 10:45:00 +0530 Hyderabad-based Biophore India Pharmaceuticals has applied for DCGI emergency use approval of Aviptadil Inhalation for marketing in India, which helps treat moderate to severe cases of COVID-19. Biophore has successfully developed Aviptadil and is backward integrated with in-house API. The company has also informed that it will be commencing commercial production immediately after the approval is received.Aviptadil is a synthetic form of Vasoactive Intestinal Peptide (VIP) that, when administered, results in rapid clinical recovery in patients with severe SARS-COV-2 infection. These observations are based on results of multiple trials of Aviptadil against COVID-19 globally in patients with respiratory failure and the same has been submitted to DCGI for their review.Dr Jagadeesh Babu Rangisetty, CEO, Biophore, says, “Biophore has developed this highly complex peptide in a very short period, primarily due to the extensive focus of the company in prioritising COVID related products over the last one year. Aviptadil is a promising treatment option for COVID, especially in severe hospitalised cases where trials have shown a high recovery percentage and we hope to be able to quickly make it available through this approval.” ]]> <![CDATA[Alkem Labs launches epilepsy drug at affordable price]]> https://biospectrumindia.com/news/95/18893/alkem-labs-launches-epilepsy-drug-at-affordable-price.html https://biospectrumindia.com/news/95/18893/alkem-labs-launches-epilepsy-drug-at-affordable-price.html Fri, 11 Jun 2021 10:10:00 +0530 Alkem Laboratories Ltd. (Alkem) has announced the launch of Perampil (Perampanel) tablets 2 mg/4 mg/6 mg to make epilepsy treatment accessible to patients and healthcare providers improving their quality of life. Mumbai-based Alkem has launched Perampil, at 2 mg – Rs. 49/strip of 7 tablets, 4 mg – Rs. 180/strip of 15 tablets and 6 mg – Rs. 300/strip of 15 tablets, to improve patient access. This product reaffirms Alkem’s commitment towards improving epilepsy care by bringing multiple treatment options of quality products to patients and health care professionals in India. Alkem had also launched Brivasure (Brivaracetam) tablets in March 2021 for the adjunctive management of partial onset seizure with or without secondary generalization. The drug, Perampanel, has been approved by the Drugs Controller General of India (DCGI), as an adjunctive therapy in treatment of partial onset seizures in patients with epilepsy aged 4 years and older and also as an adjunctive therapy in treatment of primary generalized tonic-clonic seizures in patients with epilepsy aged 12 years and older.  ]]> <![CDATA[Mankind Pharma unveils mucormycosis drug POSAFORCE]]> https://biospectrumindia.com/news/95/18889/mankind-pharma-unveils-mucormycosis-drug-posaforce.html https://biospectrumindia.com/news/95/18889/mankind-pharma-unveils-mucormycosis-drug-posaforce.html Thu, 10 Jun 2021 18:10:00 +0530 Mankind Pharma has launched Posaconazole Gastro - Resistant tablets with the brand name POSAFORCE 100. The drug is used to treat mucormycosis.    Recently Posaconazole has also been approved by the Drug Controller General of India (DCGI).   In addition, guidelines from AIIMS and ICMR have also recommended the use of Posaconazole as an effective option for the management of mucormycosis. Posaconazole is US FDA approved anti-fungal drug with minimal potential for nephrotoxicity and an excellent tolerability profile.   According to a statement issued by Mankind Pharma the product has been launched under POSACONAZOLE 100 tablets to fight against this infection. Mankind always strive to launch affordable medicines with an endeavour to achieve the best quality standards in the pharmaceutical industry. ]]> <![CDATA[CORE Diagnostics bags accreditation from College of American Pathologists]]> https://biospectrumindia.com/news/95/18878/core-diagnostics-bags-accreditation-from-college-of-american-pathologists.html https://biospectrumindia.com/news/95/18878/core-diagnostics-bags-accreditation-from-college-of-american-pathologists.html Wed, 09 Jun 2021 18:20:00 +0530 CORE Diagnostics has recently received an accreditation certification from the College of American Pathologists (CAP), a leading international laboratory accrediting organisation, based on the results of a recent assessment as part of the CAP’s Accreditation Programs.     Commenting on the accomplishment, Dinesh Chauhan, CEO, CORE Diagnostics, said, “This is another step in our company’s expansion plans and towards offering best-in-class diagnostic accuracy while complying with rigorous criteria of quality assurance to all.”    CORE Diagnostics becomes one of the nearly 8,000 CAP-accredited facilities worldwide and one of only fourteen standalone labs in India. This certification by CAP accredits a whole range of tests that includes diagnosis in fields like cardiology, oncology, endocrinology, infectious diseases, gynaecology and nephrology.    “CORE Diagnostics demonstrates leadership, innovation, and a passionate commitment to standards of excellence while providing the highest quality services, ultimately for patients,” said Richard Scanlan, FCAP, chair of the CAP’s Council on Accreditation oversees the programme.    Dr Shivani Sharma, Lab Director, CORE Diagnostics shared, “We are proud about this achievement. Being certified by CAP is a reflection of our commitment to the highest standards of quality in diagnostic testing to our clinicians, hospitals and patients.”  ]]> <![CDATA[IICT, Lee Pharma ink licensing agreement for synthesis of 2-Deoxy-D-Glucose]]> https://biospectrumindia.com/news/95/18875/iict-lee-pharma-ink-licensing-agreement-for-synthesis-of-2-deoxy-d-glucose.html https://biospectrumindia.com/news/95/18875/iict-lee-pharma-ink-licensing-agreement-for-synthesis-of-2-deoxy-d-glucose.html Wed, 09 Jun 2021 16:25:00 +0530 Indian Institute of Chemical Technology, (IICT), a constituent laboratory of CSIR and Lee Pharma, an integrated pharmaceutical company, based in Hyderabad have entered into a non-exclusive licensing agreement for the synthesis of 2-Deoxy-D-Glucose (2-DG). Recently, 2-DG developed by DRDO and Dr Reddy’s Laboratories has received approval for use in COVID-19 patients. It has been found to help speed up recovery and reduce oxygen dependence and Dr Reddy’s Laboratories has launched the drug in the form of sachets.Lee Pharma informed that they would apply to get approval from DCGI. Lee Pharma will manufacture and commercialise the 2-DG sachets from their formulation facility located at SEZ, Duvvada, Visakhapatnam, Andhra Pradesh, which has the accreditations, by global regulatory agencies.Dr Srivari Chandrashekar, Director CSIR-IICT highlighted, “There is the role of CSIR in development of 2-DG, as CSIR-CCMB tested the drug on SARS-CoV-2 viral cultures. CSIR has been engaged in the development of drugs for the treatment of COVID-19 and has undertaken many clinical trials for repurposed drugs. Additionally, this agreement with Lee Pharma is towards increasing affordable therapeutic options for treatment of COVID-19.”Raghumitra Alla, Director, Lee Pharma said, “This collaboration with CSIR-IICT for 2-DG, API is part of our broader strategy for enhancing COVID-19 treatment options. Further CSIR-IICT, Hyderabad is well-known for its high-quality research and development of various new molecules and we feel proud to be associated with them.” ]]> <![CDATA[LASA Supergenerics launches anthelmintic product Oxyclozanide]]> https://biospectrumindia.com/news/95/18874/lasa-supergenerics-launches-anthelmintic-product-oxyclozanide.html https://biospectrumindia.com/news/95/18874/lasa-supergenerics-launches-anthelmintic-product-oxyclozanide.html Wed, 09 Jun 2021 16:20:00 +0530 Lasa Supergenerics, which is into the manufacturing of veterinary and human APIs in India through its catalyst chemistry expertise and fully backward integrated unit, has launched Oxyclozanide.Oxyclozanide is an anthelmintic, it is used in the treatment and control of fascioliasis a topical worm infection in ruminants mainly domestic animals such as cattle (especially buffalos on the farm), sheep, and goats. For this, the company is setting up capacity in a brownfield expansion at its Chiplun unit. The total capacity would be 20 MT and would be funded through internal accruals. The company is committed to funding the entire capex through internal accruals. The production would start from August 2021.Dr Omkar Herlekar, CMD, Lasa Supergenerics said, “Oxyclozanide is an anthelmintic. It has a huge opportunity both in domestic as well export markets. The additional capacity is being put within the existing facility at Chiplun, Maharashtra. We would be targeting both domestic and export markets. We are excited about the launch of Oxyclozanide as it fit our product selection criteria and we are confident of grabbing a significant market share. The company is in a phase of evolution and growth and we will strive hard and deliver on the expected lines." ]]> <![CDATA[VE Commercial Vehicles launches Eicher Skyline Ambulance]]> https://biospectrumindia.com/news/95/18872/ve-commercial-vehicles-launches-eicher-skyline-ambulance.html https://biospectrumindia.com/news/95/18872/ve-commercial-vehicles-launches-eicher-skyline-ambulance.html Wed, 09 Jun 2021 11:25:00 +0530 VE Commercial Vehicles has introduced Eicher Skyline Ambulance to support healthcare mobility. The ambulances offer enhanced patient and driver safety and comfort, along with best-in-class vehicle life and a warranty of up to three years. The ambulance unit is fully customisable (covering AIS Standard B, C &D) and can be used as a mobile medical unit. Eicher Skyline ambulances are a perfect blend of Eicher engineering and lifesaving features, that bring their ‘BUILT FOR LIFE’ positioning alive.    Eicher Skyline Ambulances have a different patient and driver compartment to ensure the utmost safety of the occupants. Ambulances are equipped with auto-loading stretchers, 270 degree opening rear doors, exterior provision for oxygen cylinder and mountings, medical cabinet, etc. to provide quick and safest service to critical patients. Eicher Skyline Ambulance offers a tiltable driver cabin that is ECER- 29-02 crash test certified making it safe and easy to service. Patient compartments have sufficient room for easy movement, a doctor seat with seat belt and a squad bench along with AC and Non- AC variants.    The company has introduced three different variants of the ambulance namely Patient Transport (Type-B), Basic life support (Type-C) and Advance life support (Type-D) which can be used depending on the severity of the situation. The vehicles have all the provisions to install equipment for intensive/advanced monitoring and treatment and can function as Mobile Medical Units.   Vinod Aggarwal, MD and CEO, VE Commercial Vehicles said, “The ambulance is a consequence of rigorous research and collaboration with industry leaders and is ideal for intensive medical care."   Eicher recently donated two of the Skyline Ambulances to the government of Madhya Pradesh as part of our ongoing contributions to support the fight against this COVID pandemic.   ]]> <![CDATA[Syngene International appoints Sanjeev Sukumaran as CHRO]]> https://biospectrumindia.com/news/95/18856/syngene-international-appoints-sanjeev-sukumaran-as-chro.html https://biospectrumindia.com/news/95/18856/syngene-international-appoints-sanjeev-sukumaran-as-chro.html Mon, 07 Jun 2021 17:25:00 +0530 Syngene International has appointed Sanjeev Sukumaran as Chief Human Resource Officer (CHRO) with effect from June 1, 2021. Sukumaran succeeds Vinita Shrivastava.    As the CHRO, Sukumaran will be responsible for building on Syngene’s people-centric organisational development priorities including HR strategy development, driving organisational matrices, talent management and sustaining an inclusive work culture. His focus will be on attracting and nurturing diverse scientific talent and promote innovation, excellence and a passion for making a difference in the lives of millions by putting science to work.    Commenting on the appointment of Sukumaran, Jonathan Hunt, MD and CEO, Syngene International said, “As we continue on our journey to create a world-class innovation-focussed organisation, I am confident that Sanjeev, with his diverse experience, will be able to implement the right systems, processes and initiatives to create an environment that attracts, retains and develops the best talent.”   Sukumaran said, “I am excited to take on this role and drive the people-initiatives at Syngene. Over the last few years, Syngene has evolved to be a global scale scientific solutions provider to multiple industries. Attracting the best talent and giving them the right environment to drive innovation is critical to the organisation’s vision.”   Sukumaran joined Syngene in October 2017 as the Chief of Staff and was responsible for driving key strategic initiatives across the organisation. A Mechanical Engineer with a management degree from the Indian Institute of Management (IIM), Kozhikode and an Executive Leadership Program from INSEAD, Singapore, Sukumaran has nearly 25 years of experience in the areas of strategic management, business advisory, and people management.    Prior to joining Syngene, he has worked in a range of sectors including healthcare, life sciences, financial services, software and IT, FMCG, big data, supply chain management, e-commerce and shipping. ]]> <![CDATA[Vijaya Diagnostic Centre files DRHP with SEBI]]> https://biospectrumindia.com/news/95/18853/vijaya-diagnostic-centre-files-drhp-with-sebi.html https://biospectrumindia.com/news/95/18853/vijaya-diagnostic-centre-files-drhp-with-sebi.html Mon, 07 Jun 2021 13:40:00 +0530 Vijaya Diagnostic Centre has filed Draft Red Hearing Prospectus (DRHP) with market regulator Securities and Exchange Board of India (SEBI).  Through the initial public issue, the company aims to achieve the benefits of listing the equity shares on the stock exchanges and carry out 'Offer of Sale' of up to 3.57 crore (3,56,88,064) equity shares by the selling shareholders.    The ‘Offer for Sale’ comprises up to 0.51 crore (50,98,296) equity shares by DS Surendranath Reddy (Promoter Selling Shareholder), up to 2.95 crore (2,94,87,290) equity shares by Karakoram and up to 0.11 crore (11,02,478) equity shares by Kedaara Capital Alternative Investment Fund- Kedaara Capital AIF 1. The face value of equity share is Rs 1 each. The company will not receive any proceeds from the offer.     ICICI Securities, Edelweiss Financial Services and Kotak Mahindra Capital Company are the Book Running Lead Managers to the issue. ]]> <![CDATA[Lupin launches digital asthma educator platform]]> https://biospectrumindia.com/news/95/18852/lupin-launches-digital-asthma-educator-platform.html https://biospectrumindia.com/news/95/18852/lupin-launches-digital-asthma-educator-platform.html Mon, 07 Jun 2021 12:20:00 +0530 Lupin has launched its digital asthma educator platform. The platform guides asthma patients on the correct technique of using inhalers. The new platform is the latest initiative under Lupin’s long-running umbrella programme, Joint Airways Initiative (JAI), for patients suffering from respiratory ailments.   Rajeev Sibal, President - India Region Formulations, Lupin said, “We believe this platform would assist healthcare professionals in significantly helping their patients understand correct inhalation technique and better manage their ailment.”   Lupin will undertake a pan India integrated marketing campaign including social media and radio channels. Posts on JAI Digital Asthma Educator will be targeted at both doctors and patients.   To create awareness of the importance of correct inhalation technique, radio bytes from 50+ leading healthcare professionals will be broadcast across India on 93.5 FM. In addition to these promotions, Lupin will engage with leading healthcare professionals to launch the JAI - Digital Asthma Educator platform among all doctors in India. ]]> <![CDATA[CSIR, Laxai Life Sciences initiate Niclosamide trial for COVID-19 treatment]]> https://biospectrumindia.com/news/95/18849/csir-laxai-life-sciences-initiate-niclosamide-trial-for-covid-19-treatment.html https://biospectrumindia.com/news/95/18849/csir-laxai-life-sciences-initiate-niclosamide-trial-for-covid-19-treatment.html Mon, 07 Jun 2021 00:00:00 +0530 The Council of Scientific and Industrial Research (CSIR) in collaboration with Laxai Life Sciences has initiated Phase-II clinical trial with the anti-helminitic drug Niclosamide for the treatment of COVID-19. The trial is a multi-centric, phase-II, randomised, open-label clinical study to evaluate the efficacy, safety and tolerability of Niclosamide for the treatment of hospitalised COVID-19 patients. Niclosamide has been extensively used in past for the treatment of tapeworm’s infection in adults as well as children. The safety profile of this drug has been tested over time and has been found safe for human consumption at different dose levels. Dr Shekhar C Mande, Director General, CSIR expressed his happiness over the SEC recommendations to conduct this Phase II clinical trial using Niclosamide, which is a generic, affordable drug and easily available in India and therefore can be made available to our population. Dr Ram Vishwakarma, Advisor to DG-CSIR pointed out that in a screen to identify drugs that can inhibit syncytia formation, Niclosamide was identified as a promising repurposed drug by a research group from King’s College, London, who collaborated in this project. The syncytia or fused cells observed in the lungs of patients with COVID-19 probably results from the fusogenic activity of the SARS-CoV-2 spike protein and Niclosamide can inhibit syncytia formation. He also mentioned that independently, collaborative research between CSIR-IIIM, Jammu and NCBS, Bangalore has recently demonstrated that Niclosamide is also a potential SARS-CoV2 entry inhibitor blocking the viral entry through the pH-dependent endocytic pathway. Given these two independent experimental studies, Niclosamide has now emerged as a promising drug candidate for the clinical trial in COVID-19 patients. ]]> <![CDATA[Maha CM unveils Mylab’s COVID-19 self-test kit, CoviSelf]]> https://biospectrumindia.com/news/95/18847/maha-cm-unveils-mylabs-covid-19-self-test-kit-coviself.html https://biospectrumindia.com/news/95/18847/maha-cm-unveils-mylabs-covid-19-self-test-kit-coviself.html Fri, 04 Jun 2021 20:55:00 +0530 Udhhav Thackeray, Chief Minister of Maharashtra, unveiled Mylab Discovery Solutions’, CoviSelf, COVID-19 self-test kit. It can be used by individuals with or without symptoms and immediate contacts of confirmed cases as per the ICMR guidelines. Designed as the mid-nasal swab test, it can detect positive results in just 15 mins. Thackeray said, “Innovative ideas have the power to change the world. When these ideas come to fruition, they leave a lasting positive impact on society. It is heartening to see that young entrepreneurs from Maharashtra have made the whole country proud. Maharashtra has been a centre of innovations to help India fight this pandemic and Mylab’s contribution is very unique and gives hope to the whole country.” Dilip Walse Patil, Home Minister of Maharashtra, mentioned, “Covid-19 is a pandemic of unprecedented scale, and it takes efforts at all fronts to fight it effectively. It is great to see how entrepreneurs of the state have developed solutions that were until now only available in developed countries. We will continue to encourage innovation in healthcare and encourage start-ups to go global.” Hasmukh Rawal, Founder and MD, Mylab Discovery Solutions, a biotechnologist-turned entrepreneur from Pune, said, “Start-ups can only scale up when there is a conducive ecosystem around them. We are thankful and are committed to being the start-up from Maharashtra to make a global mark. We are very focussed on solving difficult problems in healthcare and empower every citizen with innovations like CoviSelf.” “Appreciation and support to our efforts today makes us believe in ourselves even more. It gives us the energy to launch many more innovations for Maharashtra, for the country, and for the world”, said Sujit Jain, Director, Mylab Discovery Solutions.   ]]> <![CDATA[Jubilant Pharmova posts consolidated PAT of Rs 213.90 Cr in Q4FY21]]> https://biospectrumindia.com/news/95/18846/jubilant-pharmova-posts-consolidated-pat-of-rs-213-90-cr-in-q4fy21.html https://biospectrumindia.com/news/95/18846/jubilant-pharmova-posts-consolidated-pat-of-rs-213-90-cr-in-q4fy21.html Fri, 04 Jun 2021 20:35:00 +0530 The Board of Jubilant Pharmova has approved the financial results for the quarter ended March 31, 2021. The company has reported total income of Rs 1586.47 crores during the period ended March 31, 2021 as compared to Rs 1774.93 crores during the period ended December 31, 2020. The company has posted net profit / (loss) of Rs 213.90 crores for the period ended March 31, 2021 as against net profit / (loss) of Rs 309.93 crores for the period ended December 31, 2020. It has reported EPS of Rs 13.43 for the period ended March 31, 2021 as compared to Rs 19.46 for the period ended December 31, 2020. In the year ended quarter FY 20-21, the company has reported total income of Rs 6116.18 crores during the 12 months ended March 31, 2021 as compared to Rs 6013.20 crores during the 12 months ended March 31, 2020. The company has posted net profit / (loss) of Rs 835.87 crores for the 12 months ended March 31, 2021 as against net profit / (loss) of Rs.898.24 crores for the 12 months ended March 31, 2020. It has reported EPS of Rs.52.48 for the 12 months ended March 31, 2021 as compared to Rs.56.39 for the 12 months ended March 31, 2020. Shyam S Bhartia, Chairman and Hari S Bhartia, Co-Chairman and MD, Jubilant Pharmova said, "With the demerger of LSI business into Jubilant Ingrevia effective February 1, 2021, the company’s consolidated results for Q4’FY21 include only one month of LSI business and consolidated results for FY21 include only ten months of LSI business. For FY21 our continuing operations, despite COVID-19 challenges, revenues were stable due to a diverse range of businesses. CDMO and Generics grew though we saw impact on radiopharma and had production impact at the Nanjangud API plant." They further said, "Specialty pharma segment especially radiopharma was impacted due to COVID-19 and competition in radiopharma. In radiopharmaceuticals, we are expanding our product pipeline with strategic partnerships and have begun to execute a detailed turnaround plan of radiopharmacy business. CMO and generics delivered strong growth and we plan to expand capacity in CMO and enhance number and complexity of products under development in generics." They added, "We are doubling our chemistry research capacity that should commission by Q2’FY22. Despite COVID-19 related lockdowns, we have been able to ensure continuity in most of our manufacturing operations across all business segments while at the same time ensuring safety of our employees.” ]]> <![CDATA[Ocugen expands COVAXIN commercialisation rights to include Canada]]> https://biospectrumindia.com/news/95/18834/ocugen-expands-covaxin-commercialisation-rights-to-include-canada.html https://biospectrumindia.com/news/95/18834/ocugen-expands-covaxin-commercialisation-rights-to-include-canada.html Fri, 04 Jun 2021 10:30:00 +0530 Biopharmaceutical company Ocugen and Bharat Biotech have entered into an amendment to their co-development, supply, and commercialisation agreement to expand Ocugen’s exclusive territory to commercialise COVAXIN to now also include Canada, in addition to Ocugen’s existing rights to commercialise COVAXIN in the US. “This amendment to expand our rights to commercialise COVAXIN into Canada speaks to our strong relationship with Bharat Biotech and our joint dedication to bring this unique yet traditional vaccine to additional countries. As we work towards the submission of the emergency use application in the US, we will simultaneously seek authorisation under interim order for emergency use in Canada. We believe COVAXIN has the potential to play a key role in saving lives from COVID-19 in the US and Canada, as well as across the globe, due to the strong immune response it generates against multiple antigens,” said Dr Shankar Musunuri, Chairman of the Board, CEO, and Co-founder of Ocugen. “COVAXIN has demonstrated an excellent safety record in human clinical trials and vaccine administration under emergency use in India. Our goal for all vaccines developed at Bharat Biotech is to provide global access. With its potential effectiveness against multiple existing and emerging variants, we believe that COVAXIN is an important vaccine for everyone, including children, based on its unique yet traditional vaccine platform. We are diligently working with Ocugen to bring COVAXIN to the US market and now to the Canadian market,” said Dr Krishna Ella, CMD, Bharat Biotech. As consideration for Bharat Biotech’s grant of the rights to commercialise COVAXIN in Canada, Ocugen will make an upfront payment and milestone payment upon first commercial sale in Canada to Bharat Biotech, in addition to sharing the profit from sales of COVAXINTM in Canada. Similar to the US profit share arrangement, Ocugen will retain 45 per cent of the profits from sales of COVAXIN in Canada. ]]> <![CDATA[Aragen reveals new brand identity]]> https://biospectrumindia.com/news/95/18831/aragen-reveals-new-brand-identity.html https://biospectrumindia.com/news/95/18831/aragen-reveals-new-brand-identity.html Thu, 03 Jun 2021 12:30:00 +0530 Aragen Life Sciences (Aragen), formerly known as GVK Biosciences officially marked its transition to new brand identity. The company is poised for growth in the outsourced discovery, development, and manufacturing services sector across both large and small molecule platforms. Coinciding with its 20-year history and an incoming global investor, Goldman Sachs, Aragen unfolded the new brand. Manni Kantipudi, CEO, Aragen said, “Our brand promise of ‘Together Ahead’ and our purpose 'In every molecule is the possibility for better health' reflect what Aragen does best – work with our partners and make them successful in the race for better health.”  Elaborating on the new visual brand identity and brand promise, Ramesh Subramanian, Chief Commercial Officer, Aragen said “Our new mark embodies our brand promise, Together Ahead. The seamless coming together of two forms and their collaborative movement, represent our partnerships that enable inﬁnite possibilities for better health. Our symbol which we call ‘AURA’ embodies our distinctive personality — Ambitious, Understated, Resilient and Agile. Aragen’s brand colours are loaded with symbolism and meaning. From the deep blue colour that conveys the possibilities of science, strength and resilience, the transition is made to vibrant orange which symbolises life, better health, as well as ambition and energy.”   ]]> <![CDATA[Sun Pharma inks agreement with Ferring Pharma for innovative obstetric drug]]> https://biospectrumindia.com/news/95/18820/sun-pharma-inks-agreement-with-ferring-pharma-for-innovative-obstetric-drug.html https://biospectrumindia.com/news/95/18820/sun-pharma-inks-agreement-with-ferring-pharma-for-innovative-obstetric-drug.html Wed, 02 Jun 2021 15:35:00 +0530 A wholly-owned subsidiary of Sun Pharmaceutical Industries has entered into a license agreement with Ferring Pharmaceuticals (Ferring), a subsidiary of Switzerland-based biopharmaceuticals MNC Ferring Pharmaceuticals, to commercialise a Room Temperature Stable (RTS) formulation of the obstetric drug, CARITEC (Carbetocin RTS) in India. CARITEC is indicated for the prevention of excessive bleeding in women after vaginal or caesarean childbirth. The condition is commonly known as postpartum haemorrhage (PPH). As per agreement terms, Sun Pharma is granted rights for co-marketing of the drug in India in the private market under the brand name CARITEC. Ferring has developed the drug and received approval from the Drugs Controller General of India (DCGI) for introducing the drug in India. Kirti Ganorkar, CEO-India business, Sun Pharma, said, “Through our collaboration with Ferring, we are introducing an innovative medicine that will help in reducing thousands of deaths from PPH every year. We believe this unique RTS formulation of Carbetocin will play an important role in PPH prevention in India.” ]]> <![CDATA[US FDA approves Lupin's pegfilgrastim biosimilar application]]> https://biospectrumindia.com/news/95/18819/us-fda-approves-lupins-pegfilgrastim-biosimilar-application.html https://biospectrumindia.com/news/95/18819/us-fda-approves-lupins-pegfilgrastim-biosimilar-application.html Wed, 02 Jun 2021 15:25:00 +0530 Lupin announced that the US FDA has accepted the Biologics License Application (BLA) for its proposed biosimilar to Neulasta (pegfilgrastim) through a filing using the 351(k) pathway. Pegfilgrastim has estimated annual sales of $3.66 billion in the US (IQVIA MAT December 2020). Commenting on the development, Vinita Gupta, CEO, Lupin said, “FDA’s acceptance of our BLA is a significant achievement and demonstrates our commitment to delivering products which increase access in areas of substantial medical need. This BLA expands our oncology portfolio, an area of increasing focus for Lupin. We look forward to the opportunity to bring affordable biologic options to patients and increasing access to this important treatment.” Nilesh Gupta, MD, Lupin said, “The pegfilgrastim filing is our first biosimilar filing in the US and is a milestone in our research and innovation journey as we continue to focus on delivering unique and affordable solutions to alleviate disease burden. Biosimilars is a key part of our growth strategy and we are proud of the world-class achievements of our group.’’ The BLA submission is supported by similarity data from analytical, pharmacokinetic, pharmacodynamic and immunogenicity studies. Dr Cyrus Karkaria, President, Lupin Biotech said, “With significant investment in our biotechnology division over the years, we remain committed to bringing much-needed innovative products to market. This milestone further encourages us to continue advancing our robust Biosimilars pipeline across the globe to provide an effective, affordable alternative for consumers.” ]]> <![CDATA[Biological E partners with Canadian firm to manufacture mRNA vaccines in India]]> https://biospectrumindia.com/news/95/18813/biological-e-partners-with-canadian-firm-to-manufacture-mrna-vaccines-in-india.html https://biospectrumindia.com/news/95/18813/biological-e-partners-with-canadian-firm-to-manufacture-mrna-vaccines-in-india.html Wed, 02 Jun 2021 09:45:00 +0530 Canadian firm Providence Therapeutics Holdings Inc. and Hyderabad-based Biological E have announced the execution of a term sheet, that sets forth the material terms for a definitive licensing and collaboration agreement. It also outlines the terms for sale by Providence of up to 30 million doses of Providence’s proprietary messenger RNA vaccine, PTX-COVID19-B, to Biological E and other End-buyers. This represents the sale of all the remaining 2021 Providence production, plus a portion of the early 2022 Providence production, after accounting for the first sale of Providence vaccines to the Province of Manitoba, Canada. Providence will provide the necessary technology transfer for Biological E to manufacture mRNA vaccines in India, with a minimum production capacity of 600 million doses in 2022 and a target capacity of 1 billion doses. Biological E will be responsible for all clinical development and regulatory activities for the mRNA vaccine in India and other jurisdictions licensed by Biological E. “This initiative is an important commitment by a Canada-based company to help India and other nations vaccinate their citizens against COVID19. Providence was founded to serve patients, and this commitment by Biological E allows us to achieve that essential goal,” indicated Brad Sorenson, CEO of Providence. “The mRNA platform has emerged as the front runner in delivering the first vaccines for emergency use to combat the COVID-19 pandemic. Biological E. is very pleased to be able to work with Providence on its promising mRNA vaccine candidate. We hope to provide India and other countries yet another option to ramp up their efforts towards achieving herd immunity against COVID-19,” said Mahima Datla, Managing Director of Biological E Limited. ]]> <![CDATA[Pelican BioThermal adds service offerings for pharma packaging solutions]]> https://biospectrumindia.com/news/95/18810/pelican-biothermal-adds-service-offerings-for-pharma-packaging-solutions.html https://biospectrumindia.com/news/95/18810/pelican-biothermal-adds-service-offerings-for-pharma-packaging-solutions.html Tue, 01 Jun 2021 16:55:00 +0530 Temperature-controlled packaging solutions provider Pelican BioThermal, has announced new service offerings that support customers who use single-use products, such as CoolPall Flex single-use bulk shippers and CoolGuard Advance single-use parcel shippers. The company now offers the option to condition BRIC coolants for single-use products at locations worldwide. “Over the past several years, we’ve worked to expand our presence across the globe to make our services more accessible to our customers,” said David Williams, President, Pelican BioThermal. “Yet not all of our customers could benefit from our global network. We’re excited to extend services to our single-use packaging customers, allowing them to focus on their core business--developing pharmaceutical products.” Pelican BioThermal is known for its ability to condition and deliver ready-to-use reusable products worldwide. This service helps customers who do not have the facilities, equipment or staff to condition their temperature-controlled packaging. Some customers of single-use packaging have the same needs, which is why the company is expanding its offerings to support this segment.  Strategically placed in pharma hubs and high-traffic shipping lanes across the globe, Pelican BioThermal’s network includes more than 80 locations. The company’s service centres and network stations refurbish, repair and condition a variety of reusable temperature-controlled packaging. ]]> <![CDATA[Merck extends Rs 17.85 Cr worth covid relief support to India ]]> https://biospectrumindia.com/news/95/18809/merck-extends-rs-17-85-cr-worth-covid-relief-support-to-india.html https://biospectrumindia.com/news/95/18809/merck-extends-rs-17-85-cr-worth-covid-relief-support-to-india.html Tue, 01 Jun 2021 15:45:00 +0530 Merck has extended its support to help India in its fight against COVID-19 and has announced 2 million Euros (Rs 17.85 crores) as a caring aid. The aid is being utilised for procuring equipment of 250 oxygen concentrators, 100 ventilator units, and setting up oxygen generation plants in four hospitals.  Merck India is working with state governments, government departments and non-profit service organisations managing Covid care for putting this aid to use for people who may be needing it the most. A part of this aid will also be utilised to procure medicines for emergency care of employees and their families. Sunil Punjabi, Country Speaker and Head of Research Solutions, Life Science says, “We are happy to extend this care and are confident that our aid will be supplementing the government’s efforts in addressing the need of the patients. We will continue to stand together for India, united by our clear commitment to fight the pandemic.” Merck has also taken several measures around employee safety and support for Covid treatment. The company will vaccinate all the employees in India and up to three family members. On the demise of an employee due to coronavirus infection the company has announced that the surviving family will receive an additional financial package, health insurance cover until the retirement age of the deceased and an education grant to support the education of the children until graduation. ]]> <![CDATA[ Venus Remedies posts net profit of Rs 61.77 Cr in FY 2020-21]]> https://biospectrumindia.com/news/95/18808/-venus-remedies-posts-net-profit-of-rs-61-77-cr-in-fy-2020-21.html https://biospectrumindia.com/news/95/18808/-venus-remedies-posts-net-profit-of-rs-61-77-cr-in-fy-2020-21.html Tue, 01 Jun 2021 14:25:00 +0530   Venus Remedies Ltd (VRL), a leading research and development-driven pharmaceutical company, has recorded a 61 per cent increase in annual sales in 2020-21 as compared to the previous financial year. Driven by a robust supply of active pharmaceutical ingredients by key long-associated suppliers and riding on global exports, the company’s major growth driver, VRL’s annual sales grew from Rs 339.33 crore in FY 2019-20 to Rs 548.12 crore this fiscal. Announcing its audited, consolidated and standalone financial results for the quarter and year ending March 31, 2021, the company reported a net profit of Rs 61.77 crore. Its EBITDA grew by 59 per cent in FY 2020-21 to reach Rs 73.40 crore. “As on date, there are no secured borrowings from banks or financial institutions in the books of accounts of the company,” said Saransh Chaudhary, President, Global Critical Care, Venus Remedies, while commenting on the annual results. We have been putting in dedicated efforts and resources over the past two years to strengthen our relations with suppliers and customers, which helped us in gaining their confidence and proved to be a key turning point for the company,” he said. Speaking about the highlight of its operations in FY 2020-21, Chaudhary said that while the world reeled under the adverse impact of the pandemic, VRL rose to the occasion by catering to the requirements of COVID-19 patients through medicines addressing the problem of blood coagulation and other critical care antibiotics. ]]> <![CDATA[Lilly India receives EUA for monoclonal antibody drugs for COVID-19 treatment]]> https://biospectrumindia.com/news/95/18804/lilly-india-receives-eua-for-monoclonal-antibody-drugs-for-covid-19-treatment.html https://biospectrumindia.com/news/95/18804/lilly-india-receives-eua-for-monoclonal-antibody-drugs-for-covid-19-treatment.html Tue, 01 Jun 2021 11:55:00 +0530 Eli Lilly and Company, India has received restricted emergency use approval (EUA) of its antibody drugs, bamlanivimab 700 mg and etesevimab 1400 mg, in India for the treatment of patients with mild to moderate coronavirus disease 2019 (COVID-19). Bamlanivimab and etesevimab together are indicated for restricted use in an emergency, IV route for the treatment of mild to moderate coronavirus disease 2019 (COVID-19) for injection administration in hospital settings in adults and pediatric patients (12 years of age and older weighing at least 40 kg) with RT-PCR positive results of direct SARS-COV2 viral testing and who are at high risk for progressing to severe COVID-19 and/or hospitalization and do not require oxygen.  Lilly is engaging in active dialogue with the Indian government and regulatory authorities to donate bamlanivimab and etesevimab to speed up access and provide treatment options for patients with COVID-19. Bamlanivimab and etesevimab together have been authorised under Emergency Use Authorization in the US and select EU countries, for the treatment of mild to moderate COVID-19. Speaking about its benefits for patients with COVID-19, Luca Visini, Managing Director, India Subcontinent, Lilly India, said, “We are pleased that we have another innovative treatment option to offer India’s healthcare providers who continue to be at the forefront of the battle against COVID-19. Lilly is committed to contributing to the alleviation of the COVID-19 pandemic in India and around the world. We will continue to assess and evaluate how our existing portfolio and ongoing research can benefit patients with COVID-19.” ]]> <![CDATA[Apollo Hospitals, Hyderabad bags JCI Accreditation for sixth time]]> https://biospectrumindia.com/news/95/18796/apollo-hospitals-hyderabad-bags-jci-accreditation-for-sixth-time.html https://biospectrumindia.com/news/95/18796/apollo-hospitals-hyderabad-bags-jci-accreditation-for-sixth-time.html Mon, 31 May 2021 15:25:00 +0530 Apollo Hospitals, Hyderabad has received the coveted Joint Commission International (JCI) Accreditation, for a record sixth time. JCI is an internationally acknowledged gold standard for best clinical practices in quality and patient safety and is the privilege of select few reputed healthcare institutions, globally. The distinctive accreditation reiterates Apollo Hospitals commitment and constant endeavour to offer the highest quality care and ensuring utmost safety for patients. “JCI accreditation is a testimony to Apollo’s dedication and commitment to deliver the best possible care to patients. Apollo’s patient-centric approach and care on par with the best globally enabled it to conform with JCI’s strenuous parameters. Kudos to the team and the expert clinicians for their tireless initiative and commitment to the highest quality standards spanning over the last eighteen years," says Dr Sangita Reddy, Joint Managing Director, Apollo Hospitals Group. ]]> <![CDATA[HP India, Jubilant Bhartia Foundation launch virtual helpdesk for Co-WIN registrations]]> https://biospectrumindia.com/news/95/18791/hp-india-jubilant-bhartia-foundation-launch-virtual-helpdesk-for-co-win-registrations.html https://biospectrumindia.com/news/95/18791/hp-india-jubilant-bhartia-foundation-launch-virtual-helpdesk-for-co-win-registrations.html Mon, 31 May 2021 12:15:00 +0530 HP India, in collaboration with Jubilant Bhartia Foundation (JBF), has launched a National Toll-Free Number, easing registration on the Co-WIN portal. The service will help people who have restricted or no access to smartphones or the internet and are dependent on others to register on their behalf. With a multi-lingual helpdesk, assistance will be initially available in five languages - Hindi, English, Telugu, Tamil and Kannada and more regional languages will be added soon. Through just a call at this National Toll-Free Number, people can get themselves registered on the portal from the safety of their homes. “The second wave of the pandemic has taken a huge toll on the community at large. In these unprecedented times, HP remains committed to serving the community and those impacted by the ongoing health emergency. This initiative will help many people, especially those who do not have easy internet access or digital skills, to register themselves on Co-WIN and eventually get vaccinated. Our aim is to help millions of such people across the country secure the government-mandated registration on the Co-WIN portal in the easiest possible way”, said Ketan Patel, MD, HP India Market. “We believe, the National Toll-Free Number initiative by HP India and JBF will act as a catalyst in extending the reach of the vaccination program & will help the masses to access the programme without the challenges of lack of access to technology. The health and safety of every citizen in the country are of utmost importance to us and we are committed to contributing to fight this pandemic,” said Rajesh Srivastava, MD and CEO, Jubilant Ingrevia and Director, Jubilant Bhartia Foundation. This initiative is part of HP's global commitment to fight COVID-19. Last year, HP teamed up with Redington 3D in India to produce 1.2 lakh ventilator parts for AgVa Healthcare that helped manufacture 10,000 low-cost ventilators.   ]]> <![CDATA[Glenmark's consolidated revenues grow 2.8% to Rs 1,09,439 M in FY21]]> https://biospectrumindia.com/news/95/18790/glenmarks-consolidated-revenues-grow-2-8-to-rs-109439-m-in-fy21.html https://biospectrumindia.com/news/95/18790/glenmarks-consolidated-revenues-grow-2-8-to-rs-109439-m-in-fy21.html Mon, 31 May 2021 10:50:00 +0530   Glenmark Pharmaceuticals announced its financial results for the fourth quarter and year ended March 31, 2021. For the fourth quarter of FY 2020-21, Glenmark's consolidated revenue was at Rs 28,599 million as against Rs 27,675 million recording an increase of 3.3 per cent.Consolidated EBITDA grew by 12.4 per cent to Rs 5,234 million in the quarter ended March 31, 2021 as against Rs 4,657 million in the previous corresponding quarter. The consolidated net profit was at Rs 2,339 million for the quarter ended March 31, 2021 as compared to Rs 2,203 million in the previous corresponding quarter, registering an increase of 6.2 per cent. For the year ended March 31, 2021, Glenmark's consolidated revenue was at Rs 1,09,439 million as against Rs 1,06,410 million, recording an increase of 2.8 per cent over the previous corresponding period. The consolidated EBITDA for the fiscal year ended March 31, 2021 stood at Rs 20,844 million as against Rs 16,981 million, recording an increase of 22.7 per cent in the previous corresponding period. Consolidated net profit grew by 25 per cent to Rs 9,701 million for the year ended March 31, 2021, as against Rs 7,760 million in the previous year. Earnings Per Share (EPS) is at Rs 34.38 as compared to Rs 27.5 in the previous year. "We delivered consistent performance during the year despite operational challenges due to the COVID-19 pandemic. We led from the front in India's fight against the pandemic at its very onset, with our leading brand FabiFlu," said Glenn Saldanha, CMD, Glenmark Pharmaceuticals. He further added, "We have in place strategic levers to grow our businesses sustainably, with a focus on strengthening our balance sheet." ]]> <![CDATA[UPL sets up oxygen plants across states to fight covid]]> https://biospectrumindia.com/news/95/18787/upl-sets-up-oxygen-plants-across-states-to-fight-covid.html https://biospectrumindia.com/news/95/18787/upl-sets-up-oxygen-plants-across-states-to-fight-covid.html Sat, 29 May 2021 13:40:00 +0530 UPL, a global provider of sustainable agriculture solutions, has set up oxygen plants at eight hospitals in Gujarat, Madhya Pradesh, UP and New Delhi. The company rapidly stepped up its innovation and converted four of its nitrogen production plants in Gujarat, to produce and deliver oxygen to four hospitals in Gujarat and Uttar Pradesh. The plants are 'skid mounted' and delivered directly to the hospital sites for them to be directly plugged into the hospital’s oxygen header system to help attain self-sufficiency in supply.  The converted plants have now been installed and operational at the hospitals including Government Ayurvedic College in Chauka Ghat, Varanasi, Haria L G Rotary Hospital in Vapi, Jayaben Hospital in Ankleshwar and Government Hospital in Jambusar, Bharuch. In addition to this, UPL has also installed a direct oxygen plant at Max Hospital, Patparganj, New Delhi and is in the process of providing additional three oxygen plants at Indore, Gwalior and Varanasi. All these eight oxygen plants together will be catering to ~1,000 beds. UPL has also supplied ventilators, oxygen concentrators, covid medicine kits under the supervision of the local chief medical officer in Gujarat, Madhya Pradesh and Uttar Pradesh. Jai Shroff, CEO, UPL said, “We, at UPL, are committed to our value of being ‘Always Human’. We are proud of our team who showcased exemplary agility and innovation in these tough times by developing the unique solution of converting nitrogen to oxygen. We will continue to support the community through our bit in this battle against the pandemic.” ]]> <![CDATA[Hyderabad-based IIL to produce drug substance for Covaxin]]> https://biospectrumindia.com/news/95/18786/hyderabad-based-iil-to-produce-drug-substance-for-covaxin.html https://biospectrumindia.com/news/95/18786/hyderabad-based-iil-to-produce-drug-substance-for-covaxin.html Sat, 29 May 2021 12:50:00 +0530   In a bid to augment vaccine production, the Government of India has signed an agreement with Hyderabad-based Indian Immunological Limited (IIL), which has a facility under the PSU, National Dairy Development Board.  A technical collaboration agreement has been reached between IIL and Bharat Biotech, for IIL to supply the drug substance required for manufacturing Covaxin Vaccine to Bharat Biotech. Dr K Anand Kumar, MD, IIL, said that IIL is planning to start the production of drug substance for Covaxin from next month, June 15, and send out the first batch to Bharat Biotech limited by July.  Stating that IIL is expected to produce the drug substance for about 10-15 million doses per month, Dr Anand Kumar said it will be initially two to three million doses and will be scaled up to six to seven million per month later in the year. Dr Kumar shared that they are converting the Karkapatla manufacturing unit of IIL near Hyderabad into a Bio Safety Level -3 (BSL3) facility for the production of the drug substance and is also taking up construction of another block. The IIL is also working on another COVID -19 vaccine and the animal trials are underway currently and is expected to come out by next year for human vaccination.  Under Atmanirbhar Bharat 3.0 Mission COVID Suraksha was announced by the Government of India, to accelerate the development and production of Indigenous COVID Vaccines. This is being implemented by the Department of Biotechnology. IIL Hyderabad has been sanctioned a grant of Rs 60 crore towards enhancing production capabilities. ]]> <![CDATA[PramaHikvision brings smart healthcare security solution]]> https://biospectrumindia.com/news/95/18783/pramahikvision-brings-smart-healthcare-security-solution.html https://biospectrumindia.com/news/95/18783/pramahikvision-brings-smart-healthcare-security-solution.html Fri, 28 May 2021 18:00:00 +0530 Hospitals and healthcare facilities are designed to be places of healing, recovery, and tranquillity. However, with high volumes of people constantly coming and going - visitors, volunteers, patients, and others - maintaining smooth operations and responding quickly to emergency events are becoming more challenging. PramaHikvision’s Solution for healthcare facilities helps to answer all of these concerns and more with its advanced technology, powerful cameras, and reliable recording devices. Everywhere from guard stations to intensive care units, Hikvision products powerfully assist and protect healthcare facilities and personnel, making both security and management for hospitals easier and more intelligent. In the ongoing pandemic crisis, innovative products and solutions like temperature screening thermographic cameras, temperature measurement walk-through detector and MinMoe face recognition terminal with temperature screening and face mask wearing alert, are helpful to manage large number of hospital staff, visitors, patients and doctors. Hikvision temperature screening solution, with multiple product types and wide range of applications, is designed for the detection of skin-surface temperatures so as to achieve rapid and safe preliminary screening in public areas with high efficiency in a multitude of scenarios.These include thermographic cameras, MinMoe terminals, metal detector door, deep in mind NVRs and smart onboard terminals. Hikvision offers advanced and comprehensive solutions that fluidly integrate all the moving parts, making setup and daily operations much easier for your unique conditions. The solutions include following activities and requirements, reception to patient calling, internal calling system, doctor monitoring, paging in clinic, second generation IP video intercom solution, IP VDP intercom clinic kit and analog video intercom solution. Prama Hikvision’s Smart Healthcare Security Solution covers nurse station to patient areas and other critical parts of the hospital. Prama Hikvision’s Smart Healthcare Security Solution is specially designed for hospitals and clinics, it also brings the value added convenience, security and safety to the entire ecosystem. ]]> <![CDATA[Zydus introduces new feature in drug packaging to avoid counterfeiting]]> https://biospectrumindia.com/news/95/18779/zydus-introduces-new-feature-in-drug-packaging-to-avoid-counterfeiting.html https://biospectrumindia.com/news/95/18779/zydus-introduces-new-feature-in-drug-packaging-to-avoid-counterfeiting.html Fri, 28 May 2021 16:00:00 +0530 Zydus Cadila has introduced a new feature called Zydus Verify in the packaging of its critical drugs to help patients ensure that the product is not fake or counterfeited. The company has incorporated a new IT enabled scratch code which shall be printed under a scratchable surface. The patients can check to see if the product purchased by them is genuine or not by scratching the surface and verifying the code through the app or the website. This security feature developed by Hyperlink Infosystem enables patients and institutions detect counterfeits. All that one needs to do is scratch the code and immediately verify this on an app or website, in no time. With increasing instances of counterfeit products in the market it was necessary to ensure that a 100% genuine product of Zydus is available to patients. To start with, the technology is being implemented in the Company’s products Remdac (Remdesivir) and Virafin Inj (Pegylated Interpheron Alpha 2b) and will be seen on the product packs in the third week of June. The new feature will also be extended to other products of the company. Speaking on the new initiative Dr. Sharvil Patel, Managing Director, Cadila Healthcare Ltd., said, “The problem of counterfeit drugs undermines the painstaking efforts that are put in to ensure that the end user or patients receive a product that is safe and manufactured with the highest standards of quality excellence. Counterfeit drugs can be harmful as they may not have the desired outcome and could also be life threatening in some cases. To curb this menace we looked at a user friendly solution which can reassure the patient that the product is genuine and safe. Zydus Verify is a techenabled solution that will safeguard patients against counterfeit drugs.” ]]> <![CDATA[DCDC Nephrine Renal Care, Delhi bags NABH Accreditation]]> https://biospectrumindia.com/news/95/18776/dcdc-nephrine-renal-care-delhi-bags-nabh-accreditation.html https://biospectrumindia.com/news/95/18776/dcdc-nephrine-renal-care-delhi-bags-nabh-accreditation.html Fri, 28 May 2021 13:40:00 +0530     DCDC Nephrine Renal Care in New Delhi has received the NABH (National Accreditation Board for Hospitals & Healthcare Providers) Accreditation. The centre has become the first and only standalone centre in India to receive NABH accreditation in the kidney dialysis network. The accreditation has been awarded based on an evaluation of the DCDC centre against numerous standards and objective elements. NABH is an institutional member of the International Society for Quality in Health Care (ISQua) as well as a member of the ISQua Accreditation Council. The dialysis centre in Hauz Khas has implemented quality standards set up by the NABH (National Accreditation Board for Hospitals and Healthcare Providers). Over the last many years DCDC has earned the reputation of being the most trusted in running kidney dialysis network across India. Speaking during the occasion, Aseem Garg, CEO, DCDC Kidney Care said, “NABH accreditation is a major milestone for any healthcare provider as it recognises the fact that our facilities and norms meet established quality and safety standards. This also reinforces our commitment to making quality healthcare accessible, affordable and accountable to communities who need it the most.” DCDC operates a network of dialysis and kidney care centres that provide care for acute and end-stage renal disease patients in India. The company offers dialysis services, including in-centre and home hemodialysis, peritoneal dialysis, and AV fistula and AV graft procedures and allied services that include counselling and diet and nutrition advice. ]]> <![CDATA[Metropolis Healthcare registers consolidated revenue of Rs 292 cr in Q4FY21]]> https://biospectrumindia.com/news/95/18772/metropolis-healthcare-registers-consolidated-revenue-of-rs-292-cr-in-q4fy21.html https://biospectrumindia.com/news/95/18772/metropolis-healthcare-registers-consolidated-revenue-of-rs-292-cr-in-q4fy21.html Fri, 28 May 2021 10:10:00 +0530 Diagnostic service provider Metropolis Healthcare has announced its audited consolidated financial results for Q4FY21 and FY21. The company has recorded consolidated revenue of Rs 292 crore in Q4FY21 registering a 42 per cent growth YoY. In Q4FY21, Profit after Tax (PAT) has been registered at Rs 61.3 crore as against Rs 15.5 crore in Q4FY20, resulting in a growth of 296 per cent YoY. The company posted a PAT at Rs 183.3 cr in FY21 as against Rs 127.5 crore in FY20, resulting in a growth of 44 per cent YoY. “We are pleased to post strong Q4 performance, recording our highest ever quarterly revenues driven largely by our non covid business. Metropolis continues to work and support the state governments in the fight against COVID-19. Our large capacities and expertise in specialised testing enabled us to seamlessly serve over eight lakh new customers for COVID tests. COVID tests and COVID allied tests have witnessed an uptick in Q1FY22. Our strong vision for digital transformation, our rich and growing test menu and a relentless pursuit of world-class customer experience has helped us build and grow our B2C revenues in our core markets and will help us gain market share in other key markets for us. We continue to prioritise safety, quality, and hygiene,” said Ameera Shah, Promoter and MD, Metropolis Healthcare. ]]> <![CDATA[Sun Pharma reports India sales at Rs 103,432 M for FY20-21]]> https://biospectrumindia.com/news/95/18771/sun-pharma-reportsindia-sales-at-rs-103432-m-for-fy20-21.html https://biospectrumindia.com/news/95/18771/sun-pharma-reportsindia-sales-at-rs-103432-m-for-fy20-21.html Thu, 27 May 2021 19:25:00 +0530 Sun Pharmaceutical Industries has reported financials for the fourth quarter and full-year ending March 31, 2021. In Q4FY21, the consolidated sales from operations at Rs 84,314 million, growth of 4.4 per cent over Q4 last year. The India sales at Rs 26,709 million, a growth of 12.9 per cent compared to Q4 last year. The R&D investments were at Rs 5,571 million (6.6 per cent of sales) compared to Rs 5,360 million (6.6 per cent of sales) for Q4FY20. The EBITDA was at Rs 19,568 million, up by 55.8 per cent over Q4 last year, with a resulting EBITDA margin of 23.2 per cent. The adjusted net profit for the quarter was at Rs 13,430.7 million, up by 103.3 per cent YoY, after excluding the exceptional items of Rs. 6,728.1 million, the exceptional tax item of Rs 1,212.3 million and relevant minority interest of Rs 1,026.6 million. The reported net profit for Q4FY21 was at Rs 8,941.5 million, up 124 per cent over Q4 last year. The full-year FY21 consolidated financials states that the consolidated sales from operations were at Rs 331,392 million, up by 2.5 per cent over the same period last year. India sales were at Rs 103,432 million, up by 6.5 per cent over the same period last year.  The adjusted net profit for the year was at Rs 59,317.8 million, up by 47.4 per cent YoY, after excluding the exceptional items of Rs 43,061.4 million, the exceptional tax item of Rs 4,095.1 million and relevant minority interest of Rs 8,686.7 million. The reported net profit for FY21 was at Rs 29,038.2 million, lower by 23 per cent over last year. Dilip Shanghvi, Managing Director, Sun Pharma said, “FY21 was a year marked by a highly volatile business environment due to the global Covid-19 pandemic and lockdowns in various countries. Despite these challenges, I am happy to see that we have been able to maintain business continuity and record positive overall growth. While our India business continues to outperform the average industry growth, our global speciality sales have continued to show an improving trend. Global Ilumya sales for the year have grown by 51 per cent to $143 million.” ]]> <![CDATA[Wockhardt posts Rs 433 Cr for India's continued biz in FY20-21]]> https://biospectrumindia.com/news/95/18769/wockhardt-posts-rs-433-cr-for-indias-continued-biz-in-fy20-21.html https://biospectrumindia.com/news/95/18769/wockhardt-posts-rs-433-cr-for-indias-continued-biz-in-fy20-21.html Thu, 27 May 2021 17:50:00 +0530 Wockhardt reported its fourth quarter results for Financial Year 2020-21. The company has reported an EBITDA loss of Rs (80) crore as compared to Rs 37 crore in the corresponding quarter of the previous year. Profit after Tax (PAT) for the quarter was Rs (93) crore against a marginal profit of Rs 15 crore in the previous quarter. PAT for FY21 is reported at Rs 686 crore as against a loss of Rs 69 crore in the corresponding period. Net debt-equity ratio as on March 31, 2021 stood at 0.54 (March 31, 2020 stood at 0.84). During the quarter ended March 31, 2021, India business (both continued and discontinued operations) stood at Rs 118 crore in Q4FY21 as compared to Rs 177 crore in Q4FY20. The Continuing Business stood at Rs 120 in Q4FY21 (PY Rs.74 crore) registering a growth of 63 per cent. India Business contributed 19 per cent of the global revenue. In the year ended March 31, 2021 quarter, India business stood at Rs 480 crore in FY21 as compared to Rs 883 crore in FY20. Continued operations of India Business stood at Rs 433 crore (PY Rs.402 crore) showing a growth of 8 per cent. India business continued operations contributed to 16 per cent of the global revenue. ]]> <![CDATA[Dyadic partners with Syngene for development of COVID-19 vaccine in India]]> https://biospectrumindia.com/news/95/18768/dyadic-partners-with-syngene-for-development-of-covid-19-vaccine-in-india.html https://biospectrumindia.com/news/95/18768/dyadic-partners-with-syngene-for-development-of-covid-19-vaccine-in-india.html Thu, 27 May 2021 16:00:00 +0530 US-based Dyadic International has entered into a collaboration with Bengaluru-based Syngene International to develop a COVID-19 vaccine candidate that can protect against the emerging variants of concern and which can be manufactured affordably, at very large scale, using Dyadic’s proprietary C1-cell protein production platform. Like the expanded partnership previously announced with Medytox, Inc., to co-develop vaccines in the Republic of Korea and multiple Southeast Asian countries, Dyadic will work with Syngene to develop a vaccine candidate to immunize people against current and future variants of the COVID-19 virus. Mahesh Bhalgat, COO, Syngene International stated, “We look forward to our collaboration with Dyadic to initially explore the development of a COVID-19 vaccine, and to further evaluate the potential of developing a differentiated vaccine platform based on Dyadic’s proprietary C1- cell line.” Mark Emalfarb, Dyadic’s Founder and Chief Executive Officer, commented, “We will work with Syngene to further develop our proprietary and patented C-1 cell protein production platform for its use in developing and manufacturing safe and effective vaccines. If successful, such vaccines can be manufactured rapidly and affordably, in very large quantities." ]]> <![CDATA[BDR Pharma launches affordable drug to treat ovarian, prostate cancers]]> https://biospectrumindia.com/news/95/18764/bdr-pharma-launches-affordable-drug-to-treat-ovarian-prostate-cancers.html https://biospectrumindia.com/news/95/18764/bdr-pharma-launches-affordable-drug-to-treat-ovarian-prostate-cancers.html Thu, 27 May 2021 14:10:00 +0530 BDR Pharmaceutical has launched BDPARIB (RUCAPARIB) to treat advanced ovarian and prostate cancers. BDPARIB is the first affordable generic in the India available in the form of a tablet, with the cost of therapy less expensive than any existing drugs in the market. RUCAPARIB is an oral, small-molecule inhibitor of poly (ADP-ribose) polymerase (PARP)1, 2, and 3 used as a monotherapy and in conjunction with other anti-cancer agents in several tumor forms, including ovarian and prostate cancers. It has played a significant role in treating ovarian cancer patients with BRCA mutation (germline or somatic) associated with epithelial ovarian, fallopian tube, or primary peritoneal cancer who have been treated with two or more chemotherapy.                                                                                                                              "BDPARIB was developed to treat patients living with advanced ovarian and prostate cancer with an unmet need. This research's positive results through the ARIEL3 study & TRITON2 study are highly promising and indicate that the benefits extend beyond the BRCAm population. This represents a significant advancement in the treatment of cancer patients in the future. Approvals for generics like Rucaparib, a PARP inhibitor, enables us to progress in this emerging era of personalized medicine and eradicate life-threatening diseases", said Dharmesh Shah, CMD, BDR Pharma, Mumbai. The product is priced at Rs 54,000 (Bottle of 60) for 300 Mg dose & Rs 45,000 (Bottle of 60) for 200 Mg dose. ]]> <![CDATA[Lupin announces achievement of key milestones for MEK inhibitor in difficult-to-treat cancers]]> https://biospectrumindia.com/news/95/18761/lupin-announces-achievement-of-key-milestones-for-mek-inhibitor-in-difficult-to-treat-cancers.html https://biospectrumindia.com/news/95/18761/lupin-announces-achievement-of-key-milestones-for-mek-inhibitor-in-difficult-to-treat-cancers.html Thu, 27 May 2021 13:20:00 +0530 Lupin Limited announced the achievement of key milestones for Lupin’s MEK inhibitor compound (LNP3794) that is planned for development by Boehringer Ingelheim in combination as potential targeted therapy for patients with difficult-to-treat cancers. As part of the agreement, Lupin has received payment of $50 million from Boehringer Ingelheim for achievement of key milestones. Lupin and Boehringer Ingelheim inked a licensing, development and commercialisation agreement in 2019 for Lupin’s novel oncology compound to treat KRAS-driven cancers. Lupin’s MEK inhibitor developed as part of its oncology pipeline had previously shown pre-clinical activity as a single agent as well as in combination. Lupin’s New Chemical Entity Research team is focused on building a pipeline of highly differentiated and innovative new chemical entities, primarily in the oncology space. Lupin’s NCE activities were started with the vision to use cutting-edge research in bringing novel molecules that address unmet medical needs in multiple therapeutic areas to market globally. ]]> <![CDATA[BDR Pharma launches BDPARIB to treat advanced ovarian, prostate cancers]]> https://biospectrumindia.com/news/95/18760/bdr-pharma-launches-bdparib-to-treat-advanced-ovarian-prostate-cancers.html https://biospectrumindia.com/news/95/18760/bdr-pharma-launches-bdparib-to-treat-advanced-ovarian-prostate-cancers.html Thu, 27 May 2021 12:25:00 +0530 BDR Pharmaceutical launched BDPARIB (Rucaparib) to treat advanced ovarian and prostate cancers. BDPARIB is the first affordable generic in India, available in the form of a tablet, with the cost of therapy less expensive than any existing drug in the market. Rucaparib is an oral, small-molecule inhibitor of poly (ADP-ribose) polymerase (PARP)1, 2, and 3 used as a mono-therapy and in conjunction with other anti-cancer agents in several tumour forms, including ovarian and prostate cancers. It has played a significant role in treating ovarian cancer patients with BRCA mutation (germ-line or somatic) associated with epithelial ovarian, fallopian tube, or primary peritoneal cancer who have been treated with two or more chemotherapy. "BDPARIB was developed to treat patients living with advanced ovarian and prostate cancer with an unmet need. This research's positive results through the ARIEL3 study & TRITON2 study are highly promising and indicate that the benefits extend beyond the BRCAm population. This represents a significant advancement in the treatment of cancer patients in the future. Approvals for generics like Rucaparib, a PARP inhibitor, enables us to progress in this emerging era of personalised medicine and eradicate life-threatening diseases", said Dharmesh Shah, CMD, BDR Pharma The ARIEL3 and TRITON2 study was conducted on 115 patients. Ovarian cancer patients were enrolled between April 7, 2014, and July 19, 2016, and prostate cancer patients were enrolled from May 8, 2019, to December 23, 2019. Median follow-up was more than two years. Rucaparib significantly improved progression-free survival in patients with platinum-sensitive ovarian cancer who had achieved a response to platinum-based chemotherapy. It showed a remarkable change as a new standard of care for women with platinum-sensitive ovarian cancer following complete or partial response to second-line or later platinum-based chemotherapy in a maintenance treatment setting. The treatment demonstrated significant clinical activity in men with mCRPC associated with a BRCA alteration. The trials resulted in meaningful radiographic and PSA responses, including complete responses in soft-tissue disease. The product is priced at ₹ 54,000 (bottle of 60) for 300 mg dose & ₹ 45,000 (bottle of 60) for 200 mg dose. ]]> <![CDATA[Lupin achieves key milestones for its clinical-stage MEK inhibitor compound]]> https://biospectrumindia.com/news/95/18759/lupin-achieves-key-milestones-for-its-clinical-stage-mek-inhibitor-compound.html https://biospectrumindia.com/news/95/18759/lupin-achieves-key-milestones-for-its-clinical-stage-mek-inhibitor-compound.html Thu, 27 May 2021 11:10:00 +0530 Lupin announced the achievement of key milestones for Lupin’s MEK inhibitor compound (LNP3794) that is planned for development by Boehringer Ingelheim in combination as potential targeted therapy for patients with difficult-to-treat cancers. As part of the agreement, Lupin has received payment of $50 million from Boehringer Ingelheim for the achievement of key milestones. Lupin and Boehringer Ingelheim inked a licensing, development and commercialisation agreement in 2019 for Lupin’s novel oncology compound to treat KRAS-driven cancers. Lupin’s MEK inhibitor developed as part of its oncology pipeline had previously shown pre-clinical activity as a single agent as well as in combination. Lupin’s New Chemical Entity Research team is focussed on building a pipeline of highly differentiated and innovative new chemical entities, primarily in the oncology space. Lupin’s NCE activities were started with the vision to use cutting-edge research in bringing novel molecules that address unmet medical needs in multiple therapeutic areas to market globally. ]]> <![CDATA[Vetter wins Axia Best Managed Companies Award]]> https://biospectrumindia.com/news/95/18758/vetter-wins-axia-best-managed-companies-award.html https://biospectrumindia.com/news/95/18758/vetter-wins-axia-best-managed-companies-award.html Thu, 27 May 2021 10:35:00 +0530 Vetter, a leading contract development and manufacturing organisation (CDMO), has won the Axia Best Managed Companies Award for the second time. The pharmaceutical service provider was again honoured for its clear vision, innovative approaches, sustainable management culture and sound financial management.  Every year, Deloitte Private, the German business journal WirtschaftsWoche, Credit Suisse and the Bundesverband der Deutschen Industrie (the Federation of German Industries) select which medium-sized companies are best managed and thus receive the renowned award. In keeping with the current pandemic situation, the ceremony was held on a small scale at the headquarters of the family-owned company in Ravensburg. Vetter presented convincing evidence in the evaluated categories – starting with the competent handling of the current challenges posed by the COVID-19 pandemic, to the successful acquisition of a new production site in Vorarlberg, Austria, as well as its new company strategy, Vetter Next 2029, which is currently in progress. “From the development of visionary strategies and innovative processes to effective corporate governance structures and healthy corporate culture – as an award winner, Vetter is characterised by entrepreneurial excellence. Once again, they have set new standards in several key areas of corporate governance,” emphasised Lutz Meyer, partner and head of Deloitte Private. “This award is dedicated to our 5,500 staff members worldwide,” said Senator h.c. Udo J Vetter, Chairman of the Advisory Board and member of the owner family. “The special spirit of our family-owned company is particularly evident in these challenging times.” For the company and its staff members, winning the award once again is considered both a trusted confirmation and a strong motivation.  Managing Directors Thomas Otto and Peter Soelkner shared, “We are honoured to receive the Axia Best Managed Companies Award for the second time in a row. Vetter is focused on acting proactively and sustainably – now and into the future.” ]]> <![CDATA[OptraSCAN brings affordable digital solution for scanning cytology slides ]]> https://biospectrumindia.com/news/95/18755/optrascan-brings-affordable-digital-solution-for-scanning-cytology-slides-.html https://biospectrumindia.com/news/95/18755/optrascan-brings-affordable-digital-solution-for-scanning-cytology-slides-.html Thu, 27 May 2021 00:00:00 +0530 US headquartered digital pathology firm OptraSCAN, with its development centre in Pune, has announced its intelligent solution CytoSiA for rapid yet affordable scanning and analyzing of liquid-based cytology slides and pap-smears. It is a complete solution consisting of OptraSCAN's digital pathology scanner, storage, and powerful artificial intelligence (AI) algorithms to assist pathologists and cytotechnologists in screening and detection of cervical cancer, pre-cancerous lesions, atypical cells, and all other cytologic categories. Multiple hospitals and pathology laboratories globally have already installed CytoSiA and are witnessing improved patient outcomes, increased efficiency, and productivity needed to cope with the ever-increasing demand of cytology cases.  OptraSCANS's digital scanners can scan cytology slides of size 15x15 mm area at 40x magnification in less than 60 seconds while generating the highest quality image. CytoSia incorporates patented technology- composite imaging which finds all pixels in focus from various Z plane images and stitches back to create a single layer composite image. This composite imaging technology is considerably efficient as compared to traditional Z-Stacking Technology. It allows for rapid and precise screening of the entire slide within seconds. This level of precision and quality is imperative for analyzing the samples. Furthermore, it presents to the screener images of fields that would be essential in providing a cytological interpretation, place them into categories, and filter out the redundancies. CytoSiA when used as a companion diagnostic tool, it notifies pathologists when inconsistencies between their interpretation and the AI algorithm's findings are observed, offering a safeguard against error or misinterpretation, while also improving overall care quality. ]]> <![CDATA[Samsung imports 1 M LDS syringes to boost India's vaccination drive]]> https://biospectrumindia.com/news/95/18752/samsung-imports-1-m-lds-syringes-to-boost-indias-vaccination-drive.html https://biospectrumindia.com/news/95/18752/samsung-imports-1-m-lds-syringes-to-boost-indias-vaccination-drive.html Wed, 26 May 2021 17:55:00 +0530 Samsung is importing one million innovative low dead space (LDS) syringes to support India's Covid vaccination drive. This is part of the company's Covid support programme for the country. LDS syringes minimise the amount of drug left in the syringes after an injection, reducing vaccine wastage, and thereby enabling 20 per cent more people to get the dose with the same amount of vaccine. LDS syringes, airlifted from South Korea, have been delivered to Uttar Pradesh – 325,000 each to the district administrations in Lucknow and Noida – while 350,000 LDS syringes will soon be handed over to the Greater Chennai Corporation in Tamil Nadu. These syringes will be deployed at Covid vaccination centres in the districts. This innovative syringe has been introduced for usage in a few markets including the US to optimise vaccination. "Now, as our country focusses on vaccinating the population, we are supporting this effort with innovative LDS syringes that will help reduce vaccine wastage and vaccinate more people with the same amount of vaccine," said Partha Ghosh, Vice President and Head, CSR, Samsung India.   ]]> <![CDATA[Rockwell Automation organises online forum on pharma supply chain]]> https://biospectrumindia.com/news/95/18744/rockwell-automation-organises-online-forum-on-pharma-supply-chain.html https://biospectrumindia.com/news/95/18744/rockwell-automation-organises-online-forum-on-pharma-supply-chain.html Wed, 26 May 2021 15:05:00 +0530 In an online forum titled ‘How Industry 4.0 can Strengthen India’s Pharma Sector’ business leaders from Rockwell Automation demonstrated through talks and virtual factory walkthroughs, how manufacturers in the pharmaceuticals and life sciences sector were able to deal with the complexity and scale of the supply chain challenges brought on by the COVID-19 pandemic through dynamic decision-making aided by Industry 4.0 technologies. Organised to provide a public platform to demystify the critical role of Industry 4.0 in helping the industry provide a range of essential health and medical supplies during the pandemic, the session illustrated how manufacturers were able to streamline the production of everything from hygiene products and protective gear to medical equipment and vaccines over the last year. It highlighted how new-age digital technologies have played a critical role in global vaccine discovery, production, and distribution despite facing unprecedented challenges with demand and supply shocks and regulatory hurdles at every stage. The session started with a talk on ‘How Industry 4.0 is enabling India to transform itself into the Pharmacy of the World’ by Dilip Sawhney, MD, Rockwell Automation India, where he set the tone by explaining how the Indian drug makers and healthcare brands are transforming their businesses to achieve higher productivity amid rising complexity and compliance requirements. This was further demonstrated by a virtual guided tour of the Digital Transformation Experience Centre (DTEC) to give the attendees a glimpse into the future of the industry. The tour was followed by a comprehensive presentation by Arvind Rao, global business director, Information Software, titled ‘Digital Transformation in Life Sciences’ with case studies from across the world. During his session, Rao took the audience through the entire Industry 4.0 digital transformation journey from the ‘Static & Manual’ towards a ‘Self-organizing, Dynamic, & Demand Driven’ state across a range of solutions from operational technology, information technology, data and analytics, process, workforce, automation, to Security. Rao further explained, “Many of the life sciences organisations we work with are searching for the business accelerant that will supercharge their performance. They believe digital transformation could be their answer but what’s more important than the specific technologies you’re considering are your objectives. The first step in digital transformation is achieving clarity on your business goal.” Closing the programme, Sawhney added, “Over the last four decades, we have built strong relations across the healthcare, pharma & life sciences ecosystem in India with several successful cases. As a global leader in industrial automation and digital transformation, we remain committed to helping our partners meet these emerging challenges and achieve their business goals.” ]]> <![CDATA[IndiQube partners with Care.fit, MediBuddy, MFine and PinkBlue.in]]> https://biospectrumindia.com/news/95/18743/indiqube-partners-with-care-fit-medibuddy-mfine-and-pinkblue-in.html https://biospectrumindia.com/news/95/18743/indiqube-partners-with-care-fit-medibuddy-mfine-and-pinkblue-in.html Wed, 26 May 2021 14:15:00 +0530 Bengaluru-headquartered IndiQube has partnered with Care.fit, MediBuddy, MFine, and PinkBlue.in. The partnerships are a major step for the company to provide a complete suite of wellness solutions to its 450+ clients and 40,000+ employees based out of its communes. “We at IndiQube have always been focused on providing value to our community through partnerships. We have collaborated with various partners in our endeavour to provide a complete suite of wellness solutions to our members,” said Meghna Agarwal, Co-founder, IndiQube.  “Care.fit has been at the forefront in India’s COVID-19 battle and this partnership with IndiQube would help us provide healthcare solutions to start-ups and enterprises seamlessly. We will continue to offer assistance wherever possible and remain committed to the health and well-being of the people in these testing times,” said, Madan Somasundaram, Head, Care.fit.  Satish Kannan, Co-founder & CEO, MediBuddy says, “It has been our constant endeavour to make high-quality healthcare more accessible for individuals. We are delighted to have partnered with IndiQube who share the same commitment to ensuring safety." "MFine is working with IndiQube to provide continued care to the employees and their families. MFine Covid Homecare Plan allows those with mild symptoms to fully recover from the comfort of their own homes while being monitored by a team of physicians, dietitians and pulmonologists,” said Arjun Choudhary, Founding Member and Chief Business Officer, MFine. Varun Singh, Director and Co-founder of PinkBlue.in mentioned, “During the second wave, we have been operating continuously to ensure that the Covid essentials are supplied on time." ]]> <![CDATA[Genotypic Technology partners with PMC for distributing rapid COVID-19 tests]]> https://biospectrumindia.com/news/95/18741/genotypic-technology-partners-with-pmc-for-distributing-rapid-covid-19-tests.html https://biospectrumindia.com/news/95/18741/genotypic-technology-partners-with-pmc-for-distributing-rapid-covid-19-tests.html Wed, 26 May 2021 13:20:00 +0530 Genotypic Technology announced its partnership with Premier Medical Corporation (PMC) USA for the distribution of rapid antigen and antibody kits. PMC is a reputed manufacturer of rapid tests of various diseases such as malaria, HIV, Hepatitis B and C, dengue and Syphilis, and has ISO certified world-class manufacturing facilities in Gujarat. Genotypic collaborated with PMC during the first wave of COVID-19 to develop rapid & reliable COVID-19 diagnostic products that will help in screening SARS CoV-2 in less than 20 minutes.  Commenting on the announcement, Dr Raja Mugasimangalam, Founder and CEO, Genotypic Technology said, “We have been using the antigen and antibody tests to safeguard Genotypic, Dhitiomics and QTLomics workplaces. Genotypic has been working with several technology companies to provide SARS-CoV-2 sequencing solutions to more than 1400 Indian COVID testing Labs. We are pleased to work with PMC on taking this rapid test to India and selected countries across the globe to support the fight against the COVID-19 pandemic." Nilesh Mehta, CEO and President, Premier Medical Corporation, NJ, USA added “PMC and Genotypic have collaborated to develop antigen and antibody kits for COVID-19 to cater to the community to accelerate testing as per the new guidelines. In addition to this, we also plan to co-develop novel proteins for differential diagnostics of various infectious diseases such as dengue, chikungunya, zika, ebola and others. We are elated to be able to work together to support the community in these testing times.” ]]> <![CDATA[Zydus Cadila to commercialise AmphoTLC in India to treat mucormycosis]]> https://biospectrumindia.com/news/95/18747/zydus-cadila-to-commercialise-amphotlc-in-india-to-treat-mucormycosis.html https://biospectrumindia.com/news/95/18747/zydus-cadila-to-commercialise-amphotlc-in-india-to-treat-mucormycosis.html Wed, 26 May 2021 13:00:00 +0530 TLC, a Taiwan & US-based clinical-stage specialty pharmaceutical company developing novel nanomedicines to target areas of unmet medical need, and Zydus Healthcare Limited, part of Zydus Cadila group have announced the signing of a license supply and commercialization agreement to commercialize AmphoTLC™ (Amphotericin B Liposome for Injection 50mg) in India. Under the terms of the agreement, TLC will manufacture and supply AmphoTLC™ on a non-exclusive basis to Zydus, and Zydus will commercialize AmphoTLC™ in India. AmphoTLC™ is the first and only complex generic drug to have achieved bioequivalence to Gilead’s AmBisome®, proving its sameness to the safest form of amphotericin B in the world. With the recent surge of infections in India, AmphoTLC™ will address the country’s acute liposomal amphotericin B shortage. TLC has obtained the necessary approvals for AmphoTLC™ from the regulatory authorities in India with the assistance of Zydus, including a new drug registration with Central Drugs Standard Control Organization (CDSCO) on May 25, 2021, for immediate importation as per approved usage and indication of liposomal amphotericin B. Speaking on the development, Dr. Sharvil Patel, Managing Director of Cadila Healthcare Ltd., said, “With India facing an acute shortage of the drug to treat mucormycosis, we are making this critical drug available in India on an immediate basis. The need of the hour is to tackle this life-threatening infection with a safe and effective therapy.” ]]> <![CDATA[Mankind Pharma's 'Health OK' observes tremendous response from market]]> https://biospectrumindia.com/news/95/18734/mankind-pharmas-health-ok-observes-tremendous-response-from-market.html https://biospectrumindia.com/news/95/18734/mankind-pharmas-health-ok-observes-tremendous-response-from-market.html Tue, 25 May 2021 18:15:00 +0530 Mankind Pharma has expanded its OTC range of products last month. ‘Health OK’, a multivitamin and minerals tablet launched in 2013 as a part of the drug category, has now been incorporated in the OTC category as a food supplement. In a span of a month, it has observed tremendous response from the market. 'Health OK’ tablets with their unique formulations of Natural Ginseng and Taurine helps in maintaining energy and 20 multivitamin and minerals for improving overall health. Speaking on the initiative, Joy Chatterjee, General Manager- Sales and Marketing, Mankind Pharma said, “The COVID-19 pandemic has made us realise to focus on our overall health and immunity. If a person has weak immunity he/she is more prone to get the infection. Hence, it is advised to take health supplements to build immunity which helps us fight against the infection. We are quite pleased with the fact that consumers are being aware of this, and have shown trust towards ‘Health OK tablets’, which builds immunity and overall health among people. The brand is fully committed to satisfy the aspiring needs and help consumers to get the best quality products.” The brand last month roped in Anil Kapoor and Ranveer Singh as their brand ambassadors to promote and increase brand awareness of the product. ]]> <![CDATA[VAV Life Sciences ramps up production of lipid ingredients for Liposomal Amphotericin B]]> https://biospectrumindia.com/news/95/18730/vav-life-sciences-ramps-up-production-of-lipid-ingredients-for-liposomal-amphotericin-b.html https://biospectrumindia.com/news/95/18730/vav-life-sciences-ramps-up-production-of-lipid-ingredients-for-liposomal-amphotericin-b.html Tue, 25 May 2021 15:05:00 +0530 Mumbai-based VAV Life Sciences is ramping up the production of crucial lipid ingredients needed for manufacturing Liposomal Amphotericin B, the drug used for treating mucormycosis (Black Fungus infections). Due to the surge in cases of mucormycosis, India is presently facing an acute shortage of these raw materials, leading to hindrances in the production of the Amphotericin B class of drugs. VAV Life Sciences has taken immediate steps to increase the production of the crucial lipids threefold within the next three months. The company plans to expand its present capacity of 21 kg per month to 65 kg per month, by August 2021. This would help pharma companies produce about 3 lakh vials of Liposomal Amphotericin B. VAV will also further increase its capacity to 130 kg per month by December, which would add approximately 6 lakh vials of the medication to the pharmaceutical supply chain, by the end of 2021. VAV will manufacture the lipid ingredients at its EU cGMP certified facility under its subsidiary company, VAV Lipids, based at Ratnagiri in Maharashtra. Arun Kedia, MD, VAV Life Sciences said, “The unprecedented demand of Liposomal Amphotericin B has put tremendous pressure on the supply chain for raw materials. Since our company plays such a crucial role in the supply chain, we are working round the clock to keep up with the demand from pharma companies for these crucial ingredients that will help them manufacture this medication in sufficient quantities.” ]]> <![CDATA[Balaxi Pharma posts PAT of Rs 381 million for FY21]]> https://biospectrumindia.com/news/95/18728/balaxi-pharma-posts-pat-of-rs-381-million-for-fy21.html https://biospectrumindia.com/news/95/18728/balaxi-pharma-posts-pat-of-rs-381-million-for-fy21.html Tue, 25 May 2021 11:35:00 +0530 Balaxi Pharmaceuticals (Balaxi), a branded IPR-based pharmaceutical company headquartered in Hyderabad, reported its results for the quarter and year ended March 31, 2021. The company recorded a revenue of Rs 530 million for Q4F21, the drop in revenue in the fourth quarter is normal as China is shut down for most of the quarter due to the Chinese New Year holiday. EBITDA of Rs 100 million for Q4FY21; EBITDA margin stood at 18.9 per cent. Reported PAT of Rs 84 million for Q4FY21.  For Q4FY21, the pharmaceutical business segment contributed 58 per cent of the consolidated revenues and 72 per cent of the total gross profit. Share of pharma business in total revenue increased on account of higher contribution from Guatemala and the Dominican Republic. On the gross profits front as well the pharma segment contribution increased by 500bps Q-o-Q. The ancillary business contributed 24 per cent to the revenue in Q4FY21 and 28 per cent in FY21. Share of YAP branded consumer products revenue increased from 13 per cent in Q3FY21 to 18 per cent in Q4FY21. Biscuits continue to remain a major contributor in this segment, contributing more than 90 per cent of revenue from this segment.   Ashish Maheshwari, CMD, Balaxi Pharma said, "Balaxi set its footprints into the newer geography of Nicaragua, with registration pipeline of 90 products which reflects the company's 'Land and Expand' strategy. As on date Balaxi has 552 pharmaceutical product registrations/import permits, spanning across five countries, and has a pipeline of 672 product registrations spanning six countries. Balaxi saw an increase in the share of pharma business from Guatemala and Dominican Republic, showcasing that the newer geographies have started contributing to the company's overall pharma segment. The company remains confident about achieving its long-term growth aspiration and looks forward to expanding in additional geographies. Balaxi aims to expand in 20 frontier markets over the next five years." ]]> <![CDATA[Glenmark receives US FDA approval for Icatibant Injection]]> https://biospectrumindia.com/news/95/18727/glenmark-receives-us-fda-approval-for-icatibant-injection.html https://biospectrumindia.com/news/95/18727/glenmark-receives-us-fda-approval-for-icatibant-injection.html Tue, 25 May 2021 11:05:00 +0530 Glenmark Pharmaceuticals (Glenmark) has received final approval by the United States Food & Drug Administration (US FDA) for Icatibant Injection, 30 mg/3 mL (10 mg/mL) Single-Dose Prefilled Syringe, the generic version of Firazyr 1 Injection, 30 mg/3 mL (10 mg/mL) Single-Dose Prefilled Syringe, of Shire Human Genetic Therapies. This marks Glenmark's first synthetic decapeptide injectable approval and will be manufactured in their North American manufacturing facility based in Monroe, North Carolina. According to IQVIA sales data for the 12 months ending March 2021, the Firazyr Injection, 30 mg/3 mL (10 mg/mL) Single-Dose Prefilled Syringe market2 achieved annual sales of approximately $223.4 million. Glenmark's current portfolio consists of 172 products authorised for distribution in the US marketplace and 44 ANDA's pending approval with the US FDA. In addition to these internal filings, Glenmark continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio. ]]> <![CDATA[Mapmygenome launches drive thru COVID-19 testing facility in Hyderabad]]> https://biospectrumindia.com/news/95/18723/mapmygenome-launches-drive-thru-covid-19-testing-facility-in-hyderabad.html https://biospectrumindia.com/news/95/18723/mapmygenome-launches-drive-thru-covid-19-testing-facility-in-hyderabad.html Mon, 24 May 2021 20:20:00 +0530 Mapmygenome has launched a drive thru COVID-19 testing facility at Cyient Foundation MP Primary & ZP High School in Gachibowli, Hyderabad. People who want to get a COVID-19 test for themselves and for their families can enter the school premises and follow the markings for parking spots. There are standees with barcode to the registration form, which can be filled online. Apart from names, contact details, and age, this form also requires an individual's ID proof. Sample collection executives approach the car and collect oropharyngeal and nasopharyngeal swab samples. Payment can be made online or to the executive. At every step, all COVID-19 protocols and precautions are being followed. Reports are sent online. Mapmygenome India has two COVID-19 testing labs – one at Rajiv Gandhi International Airport Hyderabad and one at their Corporate Headquarters in Madhapur. Both the labs operate 24/7. They also have a branch office and COVID-19 sample collection facility at Kukatpally. People in Hyderabad can visit the lab in Madhapur, the collection facility at Kukatpally, or the new drive thru facility at Gachibowli for COVID-19 testing. Anu Acharya, CEO, Mapmygenome, said, “We have always been extra cautious about safety and social distancing during COVID-19 sample collection and processing. We already use CoviSafe VTMs that neutralise the virus while protecting the molecular structure. This drive thru facility is an added safety measure that will enable our customers to give their samples for testing without worrying about being exposed to the virus while standing in the queue.” ]]> <![CDATA[Panacea Biotec to manufacture 100 M doses of Sputnik V per year ]]> https://biospectrumindia.com/news/95/18722/panacea-biotec-to-manufacture-100-m-doses-of-sputnik-v-per-year-.html https://biospectrumindia.com/news/95/18722/panacea-biotec-to-manufacture-100-m-doses-of-sputnik-v-per-year-.html Mon, 24 May 2021 20:05:00 +0530 The Russian Direct Investment Fund (RDIF) and Panacea Biotec, one of the leading vaccine and pharmaceutical producers in India, announced the launch of production of the Russian Sputnik V vaccine against coronavirus.  The first batch produced at Panacea Biotec’s facilities at Baddi will be shipped to the Gamaleya Center for quality control. Full-scale production of the vaccine is due to start this summer. Company’s facilities comply with GMP standards and are prequalified by WHO. As announced in April, RDIF and Panacea have agreed to produce 100 million doses per year of Sputnik V.  Kirill Dmitriev, CEO of the Russian Direct Investment Fund, said, “Launch of production in India in partnership with Panacea Biotec marks an important step in helping the country fight the pandemic. Production of Sputnik V supports efforts of India’s authorities to leave behind the acute phase of coronavirus as soon as possible while the vaccine will also be exported at a later stage to help prevent the spread of the virus in other countries around the world.” Dr. Rajesh Jain, Managing Director, Panacea Biotec, said, “This marks a significant step as we initiate production of Sputnik V. Together with RDIF, we hope to help bring a sense of normalcy back to people across the country and around the world.” ]]> <![CDATA[CORE recognises MyHealthcare's Co-founder, Aneesh Nair as influential CIO ]]> https://biospectrumindia.com/news/95/18719/core-recognises-myhealthcares-co-founder-aneesh-nair-as-influential-cio.html https://biospectrumindia.com/news/95/18719/core-recognises-myhealthcares-co-founder-aneesh-nair-as-influential-cio.html Mon, 24 May 2021 15:40:00 +0530 Aneesh Nair, Co-founder and Chief Information Officer, MyHealthcare, a speciality health tech startup, has been recognised by Centre of Recognition and Excellence (CORE) as the most influential CIOs across India. Nair has been recognised for his contribution towards building an integrated, digital patient care ecosystem that enhances clinical decision making and supports and manages long-term care using artificial intelligence (AI). This system uses complex algorithms designed to mimic human cognition and perform certain tasks in an automated fashion at a fraction of the time and cost. Under his leadership, MyHealthcare has developed solutions to help support the fight against the second wave of COVID-19. MyHealthcare started offering MyHealthcare@Home, which allows COVID patients with mild symptoms to receive the required care at home digitally, through its platform, which has built-in trackers for alerts if a patient's vitals are outside the permissible range.  Speaking on this recognition, Nair said, “It is a great honour to be part of this prestigious list. The use of technology and AI has helped in these trying times to a large extent and we need to keep this pace going. I am grateful to have had the opportunity to work in this direction at MyHealthcare and elated to have been recognised for my contribution to this space. We will aim to provide speciality healthcare to everyone in India.” Shyatto Raha, Founder and CEO, MyHealthcare said, “Nair has been instrumental in the growth of MyHealthcare since its inception and more recently in rolling out our COVID related initiatives to support hospitals and clinics in these trying times.” ]]> <![CDATA[Zydus brings world's first biosimilar ADC for breast cancer treatment]]> https://biospectrumindia.com/news/95/18716/zydus-brings-worlds-first-biosimilar-adc-for-breast-cancer-treatment.html https://biospectrumindia.com/news/95/18716/zydus-brings-worlds-first-biosimilar-adc-for-breast-cancer-treatment.html Mon, 24 May 2021 13:05:00 +0530 Ahmedabad based Zydus Cadila has launched Trastuzumab Emtansine, the first Antibody Drug Conjugate (ADC) biosimilar and a highly effective drug for treating both Early and Advanced HER2 positive Breast Cancer, under the brand name ‘Ujvira’. HER2 positive Breast Cancer is considered an aggressive form and constitutes 20 to 25% of all Breast Cancers. In a step that can significantly reduce treatment cost by almost 80%, the drug is being offered at Rs. 32495 for a 100 mg vial. The current MRP of existing Trastuzumab Emtansine drug is Rs. 1,59,225 for 100 mg vial. Ujvira will be available in two strengths, 100 mg and 160 mg. Speaking on this milestone, Dr. Sharvil Patel, Managing Director, Cadila Healthcare Limited said, “The launch of Ujvira reinforces the innovation capabilities that India has to be able to create complex therapies like ADCs and Zydus' ongoing commitment to offer breakthroughs backed by science and innovation. This research breakthrough enables access to a critical drug for patients who are undergoing therapy for Breast Cancer. We hope that with this innovation, patients will be able to adhere to the treatment and stand to benefit from the advanced technology without worrying about the cost of the treatment.” Trastuzumab Emtansine ADC biosimilar is developmental breakthrough due to its complexity in manufacturing and similarity assays. This drug is made by combining Trastuzumab and a cytotoxic compound Emtansine (DM1) with the help of a stable linker by a process called Antibody Drug Conjugation. Due to this technology the targeted delivery of the cytotoxic agent is enabled and the other toxicities on body are reduced. Ujvira is backed up with rigorous drug development programme. Patients already treated with Trastuzumab may still have the disease and would require this therapy as the next step. The high cost of therapy is a barrier to availing this therapy and Ujvira bridges this need. ]]> <![CDATA[Roche’s antibody cocktail to treat COVID-19 now available in India]]> https://biospectrumindia.com/news/95/18713/roches-antibody-cocktail-to-treat-covid-19-now-available-in-india.html https://biospectrumindia.com/news/95/18713/roches-antibody-cocktail-to-treat-covid-19-now-available-in-india.html Mon, 24 May 2021 10:00:00 +0530 Roche India and Cipla have announced that the first batch of the Antibody Cocktail (Casirivimab and Imdevimab) is now available in India while a second batch will be made available by mid-June. In total they can potentially benefit 200,000 patients as each of the 100,000 packs that will be available in India offers treatment for two patients. Cipla will distribute the product by leveraging its strong distribution strengths across the country. The drug will be available through leading hospitals and COVID treatment centres. The Central Drugs Standards Control Organisation (CDSCO) had recently provided an Emergency Use Authorisation (EUA) for the antibody cocktail (Casirivimab and Imdevimab) in India. It has also received a EUA in the US and several EU countries. The antibody cocktail (Casirivimab and Imdevimab) is to be administered for the treatment of mild to moderate coronavirus disease 2019 (COVID-19) in adults and pediatric patients (12 years of age or older, weighing at least 40 kg) who are confirmed to be infected with SARS-COV2 and who are at high risk of developing severe COVID-19 disease and do not require oxygen. It has been shown to help these high-risk patients before their condition worsens, reducing the risk of hospitalisation and fatality by 70% and shortening the duration of symptoms by four days. ]]> <![CDATA[DCAL announces study results for vitamin D deficiency]]> https://biospectrumindia.com/news/95/18706/dcal-announces-study-results-for-vitamin-d-deficiency.html https://biospectrumindia.com/news/95/18706/dcal-announces-study-results-for-vitamin-d-deficiency.html Fri, 21 May 2021 17:25:00 +0530 Dishman Carbogen Amcis Ltd (DCAL), a global outsourcing partner for the pharmaceutical industry, welcomes the results of a new study that provides critical insights into the treatment of vitamin D deficiency in obesity and fat malabsorption syndromes. The research was conducted by Boston University School of Medicine and supported in part by a grant from Dishman Carbogen Amcis' wholly-owned subsidiary CARBOGEN AMCIS. DCAL partnered with Dr Michael Holick, Professor of Medicine, Physiology and Biophysics and Molecular Medicine, Boston University School of Medicine, to determine whether alternative vitamin D-type substances provide significant health benefits in people suffering from impaired distribution and metabolism of vitamin D. “We believe that partnerships with academic institutions help uncover important insights and make great discoveries that benefit the pharmaceutical industry and, most importantly, the patients directly”, said Arpit Vyas, Global MD, DCAL. The study results will benefit obese people and, e.g., patients who have undergone gastric bypass surgery, which quite generally results in vitamin D malabsorption. Thus, those patients run an elevated risk of bone diseases like osteoporosis and osteomalacia due to softening of the bones. Researchers observed that a form of vitamin D, known as 25-hydroxyvitamin D3 (Calcifediol), was absorbed faster and better than the same dose of vitamin D. “This vitamin D metabolite is better absorbed in patients with fat malabsorption syndromes and since it is not as fat-soluble, it does not get diluted in the body fat and is effective in raising and maintaining blood levels,” said Dr Michael Holick. “Therefore, using 25-hydroxyvitamin D3 could be a novel approach for treating vitamin D deficiency in patients with fat malabsorption syndromes.” CARBOGEN AMCIS provided the 25-hydroxyvitamin D3 capsules, which were produced at its parent company DCAL's Bavla facility in Ahmedabad, specifically for this study. ]]> <![CDATA[Natco Pharma, Yashoda Hospitals start Ph III trials of Molnupiravir]]> https://biospectrumindia.com/news/95/18710/natco-pharma-yashoda-hospitals-start-ph-iii-trials-of-molnupiravir.html https://biospectrumindia.com/news/95/18710/natco-pharma-yashoda-hospitals-start-ph-iii-trials-of-molnupiravir.html Fri, 21 May 2021 17:00:00 +0530 Hyderabad based Yashoda Hospitals in their Somajigida unit will start Phase III Trials in association with Natco Pharma who received DCGI approval for conducting clinical trials for oral administration of Molnupiravir capsules for patients with mild and moderate COVID-19 symptoms. Announcing the commencement of the trials, Dr. Lingaiah Amidalya, Medical Director of Yashoda Hospitals stated that, “It is a privilege to be the first Hospital in India chosen for the Phase III of the clinical trials. We hope that the trial is a success proving it to be a game changer. If patients can be treated with Molnupiravir in the mild stage of the disease, the transmission of COVID-19 can be controlled and further worsening of the disease can be prevented at large scale. Thus, the disease burden on the healthcare system as well as the society could well be reduced, with significant implications on the financial burden of the common man and their out of pocket expense.” The Clinical trials at Yashoda Hospitals will entail the COVID patient volunteers to take 800 mg twice a day without being admitted in the hospital, since it is a OPD (out-patient department) based clinical trial, and have regular interactions with their physicians on Day 5, Day 10 and Day 15 for their follow up cycle at the Hospital.   Molnupiravir is a prodrug of the active antiviral ribonucleoside analog of β-d-N4-hydroxycytidine. Its activity against SARS-CoV-2 is by inhibition of RNA-dependent-RNA polymerase. Molnupiravir leads to errors in the viral RNA sequence, stopping viral replication, shortening infection, and limiting disease transmission. ]]> <![CDATA[Bharat Biotech ramps up COVAXIN production by additional 200 M doses ]]> https://biospectrumindia.com/news/95/18698/bharat-biotech-ramps-up-covaxin-production-by-additional-200-m-doses-.html https://biospectrumindia.com/news/95/18698/bharat-biotech-ramps-up-covaxin-production-by-additional-200-m-doses-.html Fri, 21 May 2021 10:35:00 +0530 Bharat Biotech has announced quick ramp up of additional manufacturing capacities for COVAXIN®, at CHIRON BEHRING Vaccines, Ankleshwar Gujarat, a wholly owned subsidiary of Bharat Biotech. The company plans to produce 200 million doses of COVAXIN® per annum in the good manufacturing practice (GMP) facilities that are already operational for the production of vaccines based on Inactivated Vero Cell Platform Technology, under stringent levels of GMP and biosafety. Product availability at Ankleshwar to commence from Q4 2021. Bharat Biotech had already deployed multiple production lines at its Hyderabad & Bengaluru campuses, adding Chiron Behring to this line up of high containment BSL rated GMP facilities that are required to manufacture COVAXIN®. This effectively takes the volumes upto ~ 1 billion doses per annum, with its own established campuses specialised for manufacturing inactivated viral vaccines under the highest levels of biosafety. ]]> <![CDATA[Rousselot Biomedical launches phenol-functionalised gelatin]]> https://biospectrumindia.com/news/95/18697/rousselot-biomedical-launches-phenol-functionalised-gelatin.html https://biospectrumindia.com/news/95/18697/rousselot-biomedical-launches-phenol-functionalised-gelatin.html Fri, 21 May 2021 10:30:00 +0530 Rousselot, a brand of Darling Ingredients, and the global leader of collagen-based solutions expands its range of purified, pharmaceutical-grade, modified gelatins with the launch of X-Pure GelDAT – Gelatin Desaminotyrosine. X-Pure GelDAT offers purity and consistency at scale, vital to the successful development of biomedical applications used in the human body. Dr Jeff Daelman, Business Development Manager at Rousselot Biomedical said, “Based on our extensive experience and scientific expertise in modified gelatins, we created a versatile, effective and scalable alternative to GelTYR. Rousselot Biomedical delivered a tailored X-Pure GelDAT solution, from the customer’s initial briefing into pre-clinical trials in less than a year." Rousselot’s proprietary, scalable process means products with customised functionalities can be produced in a standardised, purified, traceable and consistent manner. Rousselot offers the best of both worlds: a customised yet consistent product on which both researchers and large pharmaceutical manufacturers can rely. “Rousselot’s X-Pure GelDAT’s research-grade is functionally equivalent to the GMP grade material, so researchers have less risk of having to re-validate their biomaterial prior to clinical trials. Compromising on quality in early research can also cause significant scale-up issues and delays in preparation for clinical trials. X-Pure GelDAT can be used throughout every development phase,” said Dr Daelman. ]]> <![CDATA[BD brings immune assessment-based IVD assay for COVID-19 testing in India]]> https://biospectrumindia.com/news/95/18695/bd-brings-immune-assessment-based-ivd-assay-for-covid-19-testing-in-india.html https://biospectrumindia.com/news/95/18695/bd-brings-immune-assessment-based-ivd-assay-for-covid-19-testing-in-india.html Fri, 21 May 2021 00:00:00 +0530 In a major development, BD (Becton, Dickinson and Company) has announced the availability of its BD Multitest™ 6-Color TBNK Reagent with BD Trucount™ Tubes with an expanded clinical application in India, to help identify COVID-19 patients at increased relative risk of intubation with mechanical ventilation (IMV) and mortality, in conjunction with clinical findings and the results of other laboratory testing. By providing deeper understanding of immune responses, clinicians can better understand an appropriate course of action for patients while also prioritizing the use of precious hospital resources.  Speaking on the importance of gauging the patient’s immunity profile, Pavan Mocherla, Managing Director, BD India/South Asia, says, “As India continues to battle with this unprecedented healthcare crisis in the wake of the second wave of COVID-19, application of this immune assessment-based IVD assay amongst COVID-19 patients could potentially ease out the already choked healthcare infrastructure in the country by prioritizing hospital admission and ICU beds to those who are at higher relative risk for requiring ventilator support, and increased risk of mortality”. “BD has a long working experience with CD4 Monitoring for HIV patients through NACO, MOH&FW, Govt of India in the country. We have been supporting researchers and clinicians to understand immune functions in Cancer, Primary Immuno Deficiency and COVID-19 Vaccine research as well. We hope that that availability of this assay kit in India for expanded COVID-19 clinical application helps in optimal utilization of hospital resources,” adds Pavan Mocherla. The kit, which is approved for use in European Union, has been reviewed and approved by Drug Controller (General) India CDSCO, India to monitor the lymphocyte subsets for various applications. The test is conducted on a clinical flow cytometer which are available with major hospitals and network laboratories across India. In the current scenario of COVID-19 crisis, this information can now equip the clinician with a deeper understanding of the patient’s immune status. ]]> <![CDATA[Mylab launches CoviSelfTM, India’s first self-use rapid test for COVID-19]]> https://biospectrumindia.com/features/95/18685/mylab-launches-coviselftm-indias-first-self-use-rapid-test-for-covid-19.html https://biospectrumindia.com/features/95/18685/mylab-launches-coviselftm-indias-first-self-use-rapid-test-for-covid-19.html Thu, 20 May 2021 15:15:00 +0530 Mylab Discovery Solutions announced that it has received ICMR’s approval for India’s first self-use rapid test for COVID-19. The test is developed in India and is named as CoviSelfTM. The self-use test can be used by symptomatic individuals and immediate contacts of confirmed cases as per ICMR guidelines. Users of this test will not need sample collection by a healthcare professional. This will ease pressure on already overburdened testing labs and reduce delays in testing, which is more than 72 hours in some parts of the country.  With CoviSelfTM, Mylab aims to make testing reach doorstep of every Indian to help them fight the second and any subsequent waves of pandemic. Now, any citizen can test for COVID-19 themselves, isolate and seek treatment quickly.  Hasmukh Rawal, Managing Director, Mylab Discovery Solutions, said, “With CoviSelfTM, we are sharing the power of testing early with the citizens. It will save thousands of lives. For India, we will make millions of kits available at fraction of the cost of such kits in the US.” Each kit will be provided with all testing materials, instructions to use (IFU) leaflet and a biohazard bag to safely dispose after testing. The test is designed to be done using nasal swab (not the deep nasopharyngeal swab) to reduce the discomfort.  CoviSelfTM will provide results in 15 minutes and people who test positive should immediately isolate so that they do not infect others and quickly contact a healthcare provider. Those who test negative and continue to experience COVID-like symptoms should seek follow up care from their healthcare provider.  “This easy-to-use test combines with Myab’s AI-powered mobile app so that a user can know his/her positive status, submit the result to ICMR directly for traceability, and know what to do next in either case of result,”said Sujit Jain, Director, Mylab Discovery Solutions.  Mylab will price this test at Rs 250 and it will be available in an affordable pack of one. The company will start shipping out tests within a few days. Mylab current production capacity is 70 lakh tests per week and plans to increase its capacity to one crore tests per week within 14 days.  ]]> <![CDATA[Cipla launches ViraGen RT-PCR kit in partnership with Ubio Biotechnology]]> https://biospectrumindia.com/news/95/18681/cipla-launches-viragen-rt-pcr-kit-in-partnership-with-ubio-biotechnology.html https://biospectrumindia.com/news/95/18681/cipla-launches-viragen-rt-pcr-kit-in-partnership-with-ubio-biotechnology.html Thu, 20 May 2021 14:00:00 +0530 Cipla announced the commercialisation of a polymerase chain reaction (RT-PCR) test kit ‘ViraGen’ for COVID-19 in India, in partnership with Ubio Biotechnology Systems Pvt Ltd.  ViraGen is a real-time detection kit approved by the Indian Council of Medical Research (ICMR) and is based on multiplex PCR technology. It helps to identify and detect SARS CoV-2 N Gene and ORF Lab Gene with the sensitivity of 98.6 per cent and the specificity of 98.8 per cent as compared to a standard ICMR test. This test is designed for the qualitative detection of nucleic acid from SARS-CoV-2 in the upper and lower respiratory specimens from individuals suspected of COVID-19. ViraGen used for qualitative detection of SARS-CoV-2 will be manufactured by Ubio Biotechnology Systems and marketed and distributed by Cipla through its expansive distribution network across the country. In the current circumstances, COVID-19 RT PCR testing is extensively used throughout the country as governments, communities, and organisations are working tirelessly to track and curb the spread of the virus. The company will commence supply of the detection kit from May 25, 2021.   Commenting on the partnership, Umang Vohra, MD & Global CEO, Cipla, said, “Cipla has been working relentlessly to ensure accessibility to treatments in this fight against COVID-19. Guided by our core purpose of ‘Caring for Life’, this partnership will enable us to reach out to more people across the country at a crucial time like now.” ]]> <![CDATA[Cipla launches ViraGen as third offering in COVID-19 testing segment]]> https://biospectrumindia.com/news/95/18676/cipla-launches-viragen-as-third-offering-in-covid-19-testing-segment.html https://biospectrumindia.com/news/95/18676/cipla-launches-viragen-as-third-offering-in-covid-19-testing-segment.html Thu, 20 May 2021 05:25:00 +0530 Cipla has announced the commercialisation of a polymerase chain reaction (RT-PCR) test kit ‘ViraGen’ for COVID-19 in India, in partnership with Cochin based Ubio Biotechnology Systems.  ViraGen is Cipla’s third offering in the Covid-19 testing segment. Cipla already has partnerships for antibody detection kit and antigen test kits. ViraGen is a real-time detection kit approved by the ICMR (Indian Council of Medical Research) and is based on multiplex PCR technology. It helps to identify and detect SARS CoV-2 N Gene and ORF Lab Gene with the sensitivity of 98.6% and the specificity of 98.8% as compared to a standard ICMR test. This test is designed for the qualitative detection of nucleic acid from SARS-CoV-2 in the upper and lower respiratory specimens from individuals suspected of COVID-19. ViraGen used for qualitative detection of SARS-CoV-2 will be manufactured by Ubio Biotechnology Systems and marketed and distributed by Cipla through its expansive distribution network across the country. ]]> <![CDATA[Aknamed acquires Vardhman Health Specialties]]> https://biospectrumindia.com/news/95/18674/aknamed-acquires-vardhman-health-specialties.html https://biospectrumindia.com/news/95/18674/aknamed-acquires-vardhman-health-specialties.html Wed, 19 May 2021 16:55:00 +0530 Aknamed has announced the successful transaction with Vardhman Health Specialties. The integrated organisation with the strong proficiency in hospital focused distribution, will work towards transforming and building India’s largest healthcare supply chain platform. The transaction marks the third addition to the Aknamed Group in last 12 months, scaling the business to $200 million in annualised revenues. Over the next two years, Aknamed is aiming to invest significant additional capital to fuel the group’s organic and inorganic growth plans, while continuing to invest in people, technology and infrastructure. In fact, by the end of the current year, Aknamed will be present in 35 locations with the ability to serve over 500 cities and towns.  Naresh Chowhan, CEO, Vardhman spelling out the motivation for the transaction, remarked “This partnership underlines the growing importance of consolidation in the pharma supply chain industry in India. It opens up significantly larger opportunities, apart from the synergies derived from the combined businesses of Vardhman and Aknamed. The combination propels us to an unequivocal leadership position to tap the large growth potential of the Indian market.”   The combined teams of Aknamed and Vardhman are aiming to work towards building a robust hospital focused supply chain in India, through the use of technology, data, high quality infrastructure and scale, delivering value to hospitals, OEM partners and employees. Mahadevan Narayanamoni, Co-Founder & Chairman, Aknamed, said, “I am excited about the combination of Aknamed and Vardhman as it will solve a significant number of procurement challenges, and will broaden the horizon of healthcare supply chain in India. We also thank the continued support and guidance from our financial partners, Lightrock from LGT Group.” Deloitte Corporate Finance were the exclusive financial advisors to Vardhman on the transaction.  ]]> <![CDATA[Lily inks agreement with BDR Pharma for commercialisation of baricitinib ]]> https://biospectrumindia.com/news/95/18671/lily-inks-agreement-with-bdr-pharma-for-commercialisation-ofbaricitinib.html https://biospectrumindia.com/news/95/18671/lily-inks-agreement-with-bdr-pharma-for-commercialisation-ofbaricitinib.html Wed, 19 May 2021 13:55:00 +0530 Mumbai based BDR Pharma has announced that it has entered into a royalty-free, limited and non-exclusive voluntary licensing agreement with Eli Lilly and Company, for the manufacturing and distribution of baricitinib for the treatment of COVID-19 in India. This collaboration between BDR and Lilly will increase the availability of baricitinib in India, enhancing local treatment choices and favourably impacting the lives of those fighting COVID-19 in India. “We are swiftly working to ensure high quality manufacturing and equitable access of baricitinib for COVID-19 in India. We will continue to explore other possible initiatives to support patients and the healthcare system in India,” states Luca Visini, Managing Director, India Subcontinent, Lilly India. Commenting on the development and the royalty-free non-exclusive voluntary license with Lilly, Dharmesh Shah, Chairman, BDR Pharmaceuticals, said, "We are very pleased to partner with Lilly and this is the time to collaborate and fight the COVID-19 pandemic. The concern is to accelerate and harmonise production so that there will not be a shortage of drugs to be administered to individuals fighting the disease. We hope this collaboration will address more unmet medical needs by broadening and deepening the discovery and development of COVID-19 treatments options." BDR has applied for restricted emergency use approval with the Drug Controller General of India (DCGI) for baricitinib for COVID-19 in India. Lilly had recently announced seven voluntary license agreements with major local generic drug manufacturers in India for the production of the same. ]]> <![CDATA[Uttam Group executes eight oxygen generation plants in record time]]> https://biospectrumindia.com/news/95/18672/uttam-group-executes-eight-oxygen-generation-plants-in-record-time.html https://biospectrumindia.com/news/95/18672/uttam-group-executes-eight-oxygen-generation-plants-in-record-time.html Wed, 19 May 2021 00:00:00 +0530 Uttam Group of Companies, a multinational industry leader in Energy and Healthcare, has taken charge of handling, installing and maintaining oxygen plants that were sent to India from France to help ease the oxygen shortages experienced at hospitals over the last two weeks due to the surge in Covid-19 cases. The Group has executed eight oxygen generation plants in eight different locations in just six days.  The Govt of France has chosen Uttam Group to deliver, execute and maintain their gift of eight oxygen generation plants to the Govt of India. The oxygen plants have been set up at Dharamshila Naraina Cancer Hospital, Apollo Hospital, B.L. Kapoor Memorial Hospital, Air Force Station Palam, Sanjay Gandhi Memorial Hospital, Raja Harish Chandra Hospital, Ambedkar Nagar Hospital and TIMS in Hyderabad. These are RX400 + HP 180 generator + cylinder filling systems and together will add 400 cylinders daily to the system. Karan Bhatia, CEO, Uttam Group, said: “The hospital infrastructure in India is majorly dependent on external sources for oxygen supply, Large hospital setups are running on liquid oxygen tanks installed in their premises, but small hospitals are managing with their cylinder banks depending on gas suppliers, The plants will make the hospitals self-reliant for their oxygen requirement. It’s a step towards AATMNIRBHAR BHARAT.”  The government of NCT of Delhi has placed an order of 21 oxygen generators with the Uttam Group. Recently, all these units were installed in various government hospitals in Delhi. The production capacity of these oxygen generation plants is between 300 to 500 LPM.  These units have been manufactured by Novair France. Uttam Group has been working very closely with the Indian armed forces. It has supplied a specially designed oxygen generator for DRDO, which is successfully operating at over 16,000 ft altitude. ]]> <![CDATA[Optimus Pharma to conduct Ph III trials for Molnupiravir capsules on COVID-19 patients]]> https://biospectrumindia.com/news/95/18675/optimus-pharma-to-conduct-ph-iii-trials-for-molnupiravir-capsules-on-covid-19-patients.html https://biospectrumindia.com/news/95/18675/optimus-pharma-to-conduct-ph-iii-trials-for-molnupiravir-capsules-on-covid-19-patients.html Wed, 19 May 2021 00:00:00 +0530 Optimus Pharma, based in Hyderabad, has received the nod from the Drugs Controller General of India (DCGI) for conducting Phase III Clinical Trials for orally administered Molnupiravir capsules on patients with Mild to Moderate Covid-19. With severe shortage of antiviral drugs in the market against the SARS-CoV-2 infection, it is imperative that more drugs with potent antiviral activity against SARS-CoV-2 be introduced. Optimus Pharma having internally developed the active pharmaceutical ingredient (API) and the formulations for the product, it had filed for clinical trials with the DCGI. The regulator gave the nod for conducting the trial on mild to moderate patients. As per the clinical trial protocol approved, 2500 subjects with mild to moderate COVID-19 will be randomised in the study in a 1:1 ratio to Molnupiravir with standard supportive care or standalone standard supportive care. The treatment duration is a maximum of 5 days and the total study duration will be maximum for 29 days from randomisation, the release said. “Optimus is all geared to immediately begin clinical trials on Molnupiravir on COVID-19 patients in India. The clinical trial will let us know the efficacy of this molecule,” Chairman & Managing Director – Dr D Srinivas Reddy said.  ]]> <![CDATA[Gujarat supports scale-up of Covaxin production]]> https://biospectrumindia.com/news/95/18646/gujarat-supports-scale-up-of-covaxin-production.html https://biospectrumindia.com/news/95/18646/gujarat-supports-scale-up-of-covaxin-production.html Mon, 17 May 2021 00:00:00 +0530 Gujarat Biotechnology Research Centre (GBRC), recently established as an autonomous institute under Department of Science and Technology (DST), along with Ahmedabad based firms Hester Biosciences (poultry vaccine manufacturer) and OmniBRx have firmed up discussions with Bharat Biotech to scale up the COVAXIN technology and to produce minimum 20 million doses per month. Technology transfer agreement has been finalized. GBRC has been involved in the COVID-19 response from the beginning, providing important research insights on key issues using Genome sequencing.  On the other hand, OmniBRx has entered into the bioprocessing market with the most advanced, efficient and scalable CellBRx range of bioreactors for adherent cell culture bioprocessing. CellBRx bioreactor systems are designed for large scale and cost effective adherent cell culture based vaccine production. "A triparty consortium has been formed with Government of Gujarat as the lead partner, to explore the prospects of manufacturing the Covid vaccine through technology from Bharat Biotech. The discussions are currently on-going with Bharat Biotech towards reviewing the infrastructure at Hester, the technology adaption process and the regulatory compliances. Based on the outcome of the review, the next course of action will be determined", said Rajiv Gandhi, CEO & MD, Hester Biosciences. In addition, financial support is being provided as grant from the government to the tune of approx. Rs 65 crore to Bharat Biotech’s new Bangalore facility which is being repurposed to increase the capacity of vaccine production. ]]> <![CDATA[AOSPL enters into JV with Australian firm for Safe Space Management]]> https://biospectrumindia.com/news/95/18642/aospl-enters-into-jv-with-australian-firm-for-safe-space-management.html https://biospectrumindia.com/news/95/18642/aospl-enters-into-jv-with-australian-firm-for-safe-space-management.html Fri, 14 May 2021 20:45:00 +0530 Astute Outsourcing Services Pvt Ltd (AOSPL) recently entered into a joint venture with the Australian organisation Healthy Environments to launch Safe Space Management, a comprehensive biological defence system against infections and pathogens. The programme has been launched under AOSPL’s e-commerce division. During this pandemic, in a short span of 10 months, Astute Care has developed an exquisite suite of services and solutions that cater to all customers’ needs efficiently, economically and effectively. The organisation has also launched an app under the name ‘Astute Care’ to make it easier for their potential customers to avail themselves of their services. Astute Care is an ISO-certified on-demand concierge service. This business division focuses on providing services that cater to residential as well as commercial needs. Under the Safe Space Management programme, all the cleaning and sanitisation activities are carried out using a revolutionary new disinfectant – BioProtect. It is a unique film-forming disinfectant that kills pathogens on contact and creates an antimicrobial barrier that stays active for 28 days and with residual activity up to 90 days, preventing the transmission of germs. The organisation predominantly recruits its potential employees from the underprivileged sections. These candidates are then trained and certified at the Astute Learning and Training Academy (ALTA). This way, the organisation not only ensures the highest quality standards and 100 per cent workmanship guarantee but also generates employment opportunities in the process. “Our Safe Space Management initiative is all about introducing world-leading products and processes in the hygiene service industry to create safer and healthier spaces. It is why we have conducted thorough R&D to come up with a disinfectant that is not only effective against germs – especially COVID-19 – but is also safe and eco-friendly. The growth trajectory of the hygiene industry has risen sharply since the pandemic hit our shores as people have become more conscious about the hygiene of the places they dwell in,” said Capt Shaji Kumar, Chairman, Astute Outsourcing Services Pvt Ltd. ]]> <![CDATA[Dr Reddy's commences first dose of Sputnik V in Hyderabad]]> https://biospectrumindia.com/news/95/18638/dr-reddys-commences-first-dose-of-sputnik-v-in-hyderabad.html https://biospectrumindia.com/news/95/18638/dr-reddys-commences-first-dose-of-sputnik-v-in-hyderabad.html Fri, 14 May 2021 13:00:00 +0530 Dr. Reddy’s Laboratories announced that the first consignment of imported doses of the Sputnik V vaccine that landed in India on 1st May, 2021, received regulatory clearance from the Central Drugs Laboratory, Kasauli, on 13th May, 2021. As part of a limited pilot, the soft launch of the vaccine has commenced and the first dose of the vaccine was administered in Hyderabad today on 14th May, 2021. Further consignments of imported doses are expected over the upcoming months. Subsequently, supply of the Sputnik V vaccine will commence from Indian manufacturing partners. The imported doses of the vaccine are presently priced at an MRP of Rs 948 + 5% GST per dose, with the possibility of a lower price point when local supply begins. The Company is working closely with its six manufacturing partners in India to fulfill regulatory requirements to ensure smooth and timely supply. Dr. Reddy’s will work closely with stakeholders in the Government and private sector in India to ensure the widest possible reach of the Sputnik V vaccine as part of the national inoculation effort. This is a reaffirmation of the Company’s commitment to explore every avenue in the fight against the COVID-19 pandemic in India. G V Prasad, Co-Chairman and Managing Director, said: “With the rising cases in India, vaccination is our most effective tool in our battle against COVID-19. Contributing to the vaccination drive in India is our biggest priority right now to help Indians be healthy and safe.” ]]> <![CDATA[Roche India donates Rs 40+ Cr worth of Tocilizumab to fight COVID-19]]> https://biospectrumindia.com/news/95/18640/roche-india-donates-rs-40-cr-worth-of-tocilizumab-to-fight-covid-19.html https://biospectrumindia.com/news/95/18640/roche-india-donates-rs-40-cr-worth-of-tocilizumab-to-fight-covid-19.html Fri, 14 May 2021 01:05:00 +0530 Roche India has donated Rs 40+ crores worth of Tocilizumab (Brand: Actemra) to India. Fifty thousand vials of Tocilizumab (Brand: Actemra) 80 mg are being donated to the Ministry of Health and Family Welfare (MoHFW), Government of India to help patients during the pandemic. The supplies reached India on 11 May 2021 and will be handed over to the MohFW in the next few days. “In these unparalleled times of crisis, Roche is doing everything we can to deliver life-saving medications to patients in India. We are hopeful that this donation will strengthen the nation’s ongoing efforts to fight the pandemic through enhanced access to Tocilizumab. We are extremely thankful to the Ministry of External Affairs, Ministry of Health and Family Welfare, and Niti Aayog for their collaboration”, said V. Simpson Emmanuel, Managing Director, Roche Pharma India Given the unprecedented demand for Tocilizumab, Roche is urgently working to increase manufacturing capacity and supply by ramping up its own production network, as well as actively collaborating with external partners to maximize production of Actemra wherever possible with the goal of increasing its availability. "However, we are mindful that the current unprecedented demand may far exceed the supplies we can provide at this moment", Emmanuel added. ]]> <![CDATA[FICCI supportive of ‘TRIPS waiver’ proposal to ramp up COVID-19 vaccines manufacturing]]> https://biospectrumindia.com/news/95/18631/ficci-supportive-of-trips-waiver-proposal-to-ramp-up-covid-19-vaccines-manufacturing.html https://biospectrumindia.com/news/95/18631/ficci-supportive-of-trips-waiver-proposal-to-ramp-up-covid-19-vaccines-manufacturing.html Thu, 13 May 2021 15:40:00 +0530 FICCI is encouraged by the US support for the ‘TRIPS waiver’ proposal, first advocated by India and South Africa as one vital tool to address the concerns on availability of COVID-19 vaccines. "We are confident, if accepted in the WTO and implemented, the temporary waiver would go a long way to enable scaling up of manufacturing and ensuring timely availability of affordable COVID-19 vaccines and essential medical products," says FICCI. While the Indian Government is currently working towards the multilateral solution, there are other proposals eg invoking ‘Compulsory Licenses’ to alleviate the shortage of vaccines. However, it may not lead to ‘enhancing’ the manufacturing capacity in the near future. This is due to the fact that lack of availability of essential raw materials and inputs poses significant constraint to the quick expansion of production capacity of the COVID vaccines. Further, several regulatory and safety issues will have to be addressed, and this may take some time.  The provision of Compulsory Licensing must be used cautiously and with utmost discretion. If not used judiciously, it may discourage innovator companies, which have heavily invested in R&D, and turn out to be counterproductive to the present situation. Further, FICCI strongly believes that in the larger and long-term interest of the country and its citizens, India should not rush to do anything unilaterally that may undermine its present efforts to arrive at a ‘multilateral solution’ on this issue. This approach will be more acceptable to the global business and larger community worldwide. Our efforts should be to find a ‘fine balance’ between effectively managing India’s present public health concerns on the one hand, amply demonstrating that India values and respects the global rules on IPR / TRIPS Agreement, on the other. The immediate focus has to be on connecting with the ‘right’ global companies to facilitate ‘technology transfer’ and voluntary licenses to Indian companies that have the capacity and capability for mass-production of COVID vaccines. This will be a definite game-changer and help in creating a robust manufacturing ecosystem with scalability in the country. FICCI believes that the government has initiated steps in this direction, and we believe that these should be concluded soon.   ]]> <![CDATA[Lilly issues licenses to Dr Reddy’s, MSN, Torrent Pharma for commercialisation of baricitinib]]> https://biospectrumindia.com/news/95/18629/lilly-issues-licenses-to-dr-reddys-msn-torrent-pharma-for-commercialisation-of-baricitinib.html https://biospectrumindia.com/news/95/18629/lilly-issues-licenses-to-dr-reddys-msn-torrent-pharma-for-commercialisation-of-baricitinib.html Thu, 13 May 2021 13:35:00 +0530 Eli Lilly and Company announced that it has issued additional royalty-free, non-exclusive voluntary licenses to established Indian pharmaceutical manufacturers of generic medicines, Dr Reddy’s Ltd, MSN Laboratories and Torrent Pharmaceuticals, who will be collaborating with Lilly to accelerate and expand the availability of baricitinib in India. These three additional voluntary licensing agreements will ensure high quality manufacturing and accessibility of baricitinib during this pandemic improving the local treatment options available to positively impact the lives of people who are currently battling COVID-19 in India.  Commenting on the development, Luca Visini, Managing Director, India Subcontinent, Lilly India, said, “We are swiftly working to ensure high quality manufacturing and equitable access of baricitinib for COVID-19 in India by issuing six voluntary licenses for baricitinib to pharmaceutical companies in India. We will continue to explore other possible initiatives to support patients and the healthcare system in India.” In a continued effort to work closely with the Government of India and partners to ensure expanding availability of Lilly therapies in private or public markets, Lilly had announced donations of baricitinib through the humanitarian aid organisation, Direct Relief, to the Indian government for eligible hospitalised COVID-19 patients in India. This donation furthers both Lilly and Direct Relief's charitable goal of providing access to COVID-19 treatments to patients in need. Meanwhile Lilly continues to engage in active dialogue with the regulatory authorities and government in India to donate Lilly’s anti-COVID-19 treatments, including Lilly’s neutralising antibodies (bamlanivimab and etesevimab to be administered together).   ]]> <![CDATA[Bharat Biotech to conduct Ph II/III trial of Covaxin on under-18]]> https://biospectrumindia.com/news/95/18628/bharat-biotech-to-conduct-ph-ii-iii-trial-of-covaxin-on-under-18.html https://biospectrumindia.com/news/95/18628/bharat-biotech-to-conduct-ph-ii-iii-trial-of-covaxin-on-under-18.html Thu, 13 May 2021 09:05:00 +0530 The Drugs Controller General of India (DCGI), after careful examination, has accepted the recommendation of Subject Expert Committee (SEC) and accorded permission to conduct the Phase II/III clinical trial of Covaxin (COVID vaccine) in the age group 2 to 18 years, to its manufacturer Bharat Biotech Ltd. Bharat Biotech will be carrying out a Phase- II/III clinical trial of Covaxin in the age group of 2 to 18 years. The trial will be conducted in 525 healthy volunteers. In the trial, the vaccine will be given by intramuscular route in two doses at day 0 and day 28. As rapid regulatory response, the proposal was deliberated in Subject Expert Committee (SEC) (COVID-19) on 11.05.2021. The Committee after detailed deliberation recommended for grant of permission to conduct proposed Phase II/III clinical trial to certain conditions. ]]> <![CDATA[Granules to donate 16 Cr Paracetamol tablets to Telangana govt]]> https://biospectrumindia.com/news/95/18626/granules-to-donate-16-cr-paracetamol-tablets-to-telangana-govt.html https://biospectrumindia.com/news/95/18626/granules-to-donate-16-cr-paracetamol-tablets-to-telangana-govt.html Thu, 13 May 2021 00:00:00 +0530 Granules, a vertically integrated pharmaceutical company headquartered in Hyderabad, has announced it has pledged to provide the Government of Telangana Paracetamol-500 mg tablets free of cost to fight the COVID-19 pandemic.The company will provide 1 crore tablets every week, starting from today 12th May 2021, aggregating to 16 crore tablets worth Rupees Eight Crores over next 4 months.  Uma Devi Chigurupati, Executive Director, Granules India, said, "we believe that this contribution will complement the Government of Telangana’s efforts in fighting the COVID-19 pandemic in the State of Telangana.""Paracetamol is one of the most important drugs in the COVID treatment regimen. Being one of the largest producers of Paracetamol, it’s is our responsibility to make it available to the patients.”, Uma added. ]]> <![CDATA[Brinton Pharma triples up production of COVID-19 drug Favipiravir]]> https://biospectrumindia.com/news/95/18621/brinton-pharma-triples-up-production-of-covid-19-drug-favipiravir.html https://biospectrumindia.com/news/95/18621/brinton-pharma-triples-up-production-of-covid-19-drug-favipiravir.html Wed, 12 May 2021 13:00:00 +0530 Pune based Brinton Pharmaceuticals has more than triple up the production of Faviton (Favipiravir 400) tablet, the Covid-19 drug. Favipiravir is used as an oral antiviral therapy for mild to moderate cases of Covid-19. It has also increased the production of additional drugs Scabover & Iverbond (Ivermectin 12 mg ) Tablet and Doxybond LB & Briodox (Doxycycline) Tablet which are also used towards the treatment of covid-19. Since Faviton helps curb mild to moderate symptoms, if taken at the right time under medical supervision, it can help cut down the trips to the hospital. This decision comes at a time where people are finding it hard to find hospital beds for their loved ones and more deaths are being seen because hospitals don’t have enough oxygen supply. Patients are also facing shortages of these medicines that are crucial to treat the virus. At a time like this, Brinton’s call to increase productions from 15 lac to 50 lac quantity, they will further  continue to increase the production of its crucial medicines to help save many lives. Moreover, Brinton is providing Faviton at an economical price (Rs 790/ 10 tablets) there by further helping the end patients and their families. ]]> <![CDATA[ICPA suggests govt to include chlorhexidine mouthwash for COVID‐19 prevention]]> https://biospectrumindia.com/news/95/18613/icpa-suggests-govt-to-include-chlorhexidine-mouthwash-for-covid19-prevention.html https://biospectrumindia.com/news/95/18613/icpa-suggests-govt-to-include-chlorhexidine-mouthwash-for-covid19-prevention.html Wed, 12 May 2021 00:00:00 +0530 ICPA Health Products Ltd (ICPA), Mumbai based pharmaceutical company, has submitted a representation to the Government requesting the inclusion of Chlorhexidine mouthwash to the list of precautionary measures and best health practices to reduce COVID19 transmission effectively. In the representation, ICPA has cited multiple independent studies that indicated that rinsing the mouth and gargling the throat with Chlorhexidine mouthwash eliminates the virus and reduces its transmission. ICPA has suggested to the Government that along with safe distancing, hand sanitization, proper use of masks and eyewear, the use of Chlorhexidine mouthwash can reduce virus transmission. “India is witnessing a record number of cases in the second wave of the COVID-19 pandemic. Although vaccines seem like the best option to develop herd immunity at the community level and to prevent the spread of infections, its implementation will take time to cover the entire population. In the interim, we urgently need measures that will help us crush the curve by preventing the spread and by reducing the severity of the infection. We need an inexpensive and effective solution to control the pandemic. Studies have suggested that Chlorhexidine mouthwash is a safe and straightforward addition to the current COVID‐19 prevention guidelines which is also inexpensive and widely available,” says Abha Damani, Director, ICPA Health Products Ltd. ]]> <![CDATA[Livinguard donates antiviral masks worth Rs 15 Cr for protection of COVID-19 warriors]]> https://biospectrumindia.com/news/95/18616/livinguard-donates-antiviral-masks-worth-rs-15-cr-for-protection-of-covid-19-warriors.html https://biospectrumindia.com/news/95/18616/livinguard-donates-antiviral-masks-worth-rs-15-cr-for-protection-of-covid-19-warriors.html Tue, 11 May 2021 20:40:00 +0530 Livinguard AG has donated antiviral masks worth Rs 15 crore for the protection of COVID warriors through NGOs, government organisations, civil society, hospitals, and numerous healthcare centres. This will ensure that our brave frontline heroes are especially protected with the most superior patented antiviral and antibacterial technology on textile, rather than just being sufficiently protected.  Speaking on the initiative, Sanjeev Swamy, Founder, Inventor & CEO, Livinguard AG, stated, “Through this initiative of ours, we aim to protect these unsung COVID heroes who are risking their lives each day to help us win this war.” Under this initiative, Livinguard AG has donated masks to several NGOs and organisations like Child Relief and You (CRY), Magic Bus, Apnalaya, Mumbai Police, Tata Memorial, Punjab Police, ISB Students, Educate Girls, 108 Ambulance, Concern, India, Helping hands, Crematorium Workers, Freedom for You Foundation, Coro India, K Shamanta NGO, Sadhu Vaswani Mission, Radaswami Satsung Beas, Bharathy Thahliani and Shri Dinkar Gupta, IPS, DGP, CHANDIGARH and others.  Kreeanne Rabadi, Regional Director - West, CRY, stated, “CRY is so grateful to Livinguard for donating to us 25,000 high quality face masks with anti-microbial technology. The masks will be sent to front-line workers in our project areas.”  Livinguard masks are available across leading e-commerce platforms like Amazon, Nykaa, Flipkart, PharmEasy and in leading pharmacies and chemists like Wellness Forever, Health & Glow, and Noble Chemists. ]]> <![CDATA[Paytm donates 100 oxygen concentrators & oxygen-generating plant to Gujarat governor]]> https://biospectrumindia.com/news/95/18611/paytm-donates-100-oxygen-concentrators-oxygen-generating-plant-to-gujarat-governor.html https://biospectrumindia.com/news/95/18611/paytm-donates-100-oxygen-concentrators-oxygen-generating-plant-to-gujarat-governor.html Tue, 11 May 2021 19:30:00 +0530 Acharya Devvrat, Governor of Gujarat, plans to deploy a massive grass-root level initiative to combat and manage the current pandemic situation by bringing about a difference through the ‘Corona Sewa Yagna’ initiative. Paytm Foundation has donated 100 oxygen concentrators along with an oxygen-generating plant to the Gujarat governor to help meet the medical oxygen requirement of hospitals to combat the second wave of COVID-19. Devvrat through ‘Corona Sewa Yagna’ – LIFE initiative, has activated deployment of oxygen concentrators, deploying oxygen concentrator’s at hospitals will also help in reducing dependence on refilling cylinders and their transport. The oxygen concentrators will be sent to public hospitals, COVID-19 clinics, primary health centres, dedicated COVID-19 hospitals and health centres.  Speaking on the ‘Corona Sewa Yagna’, Devvrat said, “In the second phase of the initiative, we have successfully activated deployment of oxygen concentrators to meet the urgent need to treat patients with oxygen therapy." Vijay Shekhar Sharma, Founder & CEO – Paytm, said, "We aim to converge our resources along with the state government's initiatives to save as many lives of the people of Gujarat.”  Amitabh Shah, Founder, Yuva Unstoppable said, “To be able to provide the necessary aid during this pandemic time and enable deployment of medical oxygen concentrators remains crucial to combat the shortage in supply of medical oxygen. We remain wholeheartedly committed to the cause and remain grateful to various corporates who are supporting us in this hour of crisis.”   ]]> <![CDATA[RxDx Healthcare ramps up COVID care at home packages]]> https://biospectrumindia.com/news/95/18606/rxdx-healthcare-ramps-up-covid-care-at-home-packages.html https://biospectrumindia.com/news/95/18606/rxdx-healthcare-ramps-up-covid-care-at-home-packages.html Tue, 11 May 2021 10:10:00 +0530 As the cry for oxygen and hospital beds continue to haunt the country, RxDx Healthcare, a chain of telemedicine enabled primary care clinics in Bengaluru, has rapidly ramped up its covid care at home packages with an aim to prevent hospitalisations and reduce the load on hospital beds. It is currently managing 375 active patients at home and is ramping up capacity to 2000 active patients being treated at home at a time. This would amount to the work done by ten 200-bedded hospitals. According to Dr. Chhavi Mehra, Quality Head at RxDx Healthcare, thus far, less than 10% of the 2000 patients managed at home by the RxDx team have needed to be referred to the hospital for admission. Home care includes 1) tele consultations with doctors, physiotherapists, nutritionists and counsellors 2) daily monitoring of vitals (including the oxygen saturation reading via the oximeter) and 3) pharmacy prescriptions and home drop offs plus nursing visits at home for lab blood draws or testing within Bengaluru. Unlike public perception, COVID care at home is not just monitoring the patient but also prescribing early and ongoing treatment with medications such as inhalational steroids, anti-virals and anti-clotting medications to reduce the chance of worsening inflammation and cytokine storms. The adults consult physicians and internal medicine specialists while children receive paediatrician's consultations. ]]> <![CDATA[Dabur India enters pain relief spray market with launch of ‘Dabur Rheumatil Spray’]]> https://biospectrumindia.com/news/95/18599/dabur-india-enters-pain-relief-spray-market-with-launch-of-dabur-rheumatil-spray.html https://biospectrumindia.com/news/95/18599/dabur-india-enters-pain-relief-spray-market-with-launch-of-dabur-rheumatil-spray.html Mon, 10 May 2021 16:10:00 +0530 Dabur India Ltd has announced its entry into the pain relief spray market with the launch of Ayurvedic ‘Dabur Rheumatil Spray’. Priced at Rs. 130 for 40g/ 57 ml pack, Dabur Rheumatil Spray is available across all leading e-commerce platforms and through regular retail channels. Announcing the launch, which marks the extension of Dabur’s Ayurvedic Pain Relief brand Rheumatil into the spray category, Dr. Durga Prasad, Marketing Head-Ethicals, Dabur India Ltd, said, “Dabur Rheumatil Spray is a unique blend of time-tested Ayurvedic ingredients like turpentine, eucalyptus, peppermint, gandhapura and dalchini with oil of wintergreen and menthol for rapid and effective relief from muscle pain. This not only marks our entry into a new category, but further boosts our Ayurvedic Healthcare products portfolio.” Prepared after extensive R&D, the new Dabur Rheumatil Spray gives fast and long-lasting relief from pain and strain of the muscles, backache, neck pain, shoulder & knee pain. “Its unique formulation gets absorbed quicker, penetrates deep to reach the source of pain and reduce inflammation. Backed by 137 years of Dabur's Ayurvedic Knowledge, Rheumatil Spray is completely safe on skin. Dabur Rheumatil Spray is also effective in treating pain from arthritis, fibrositis, stiff neck, lumbar spondylitis, frozen shoulders, lumbago, backaches, muscular sprains and spasms,” added Dr Prasad.   ]]> <![CDATA[RapiPay to facilitate COVID-19 vaccination registration]]> https://biospectrumindia.com/news/95/18598/rapipay-to-facilitate-covid-19-vaccination-registration.html https://biospectrumindia.com/news/95/18598/rapipay-to-facilitate-covid-19-vaccination-registration.html Mon, 10 May 2021 16:00:00 +0530 RapiPay Fintech will be facilitating COVID-19 vaccination registration through its agent app and website. Currently, RapiPay’s B2B app has more than five lakh installs from retailers and merchants. RapiPay has used a tool on its website and app that redirects users to Covid vaccination data available on CoWIN website on live basis. Lakhs of RapiPay agents access this app daily to serve crores of customers for payments, AEPS and remittance services. Using the same app, the agents will be able to seamlessly assist their customers to check vaccination availability in their area and accordingly register for the vaccination slot. RapiPay has used a tool on its website and app that redirects users to Covid vaccination data available on CoWIN website on live basis. Lakhs of RapiPay agents access this app daily to serve crores of customers for payments, AEPS and remittance services. Using the same app, the agents will be able to seamlessly assist their customers to check vaccination availability in their area and accordingly register for the vaccination slot. Commenting on this announcement, Yogendra Kashyap, CEO, RapiPay said, “In this hour of need, all of us must do our bit to combat this pandemic. Millions of non tech users, especially in the rural markets, might not be able to register on CoWIN or Aarogya Setu app on their own. With this initiative, their vaccination registration can be facilitated through our direct business outlets (DBOs) who use RapiPay daily for their business.  We are hopeful that with this facility a lot of people will not crowd the immunisation centre and help maintain social distance which is the need of the hour.” ]]> <![CDATA[Lilly inks agreement with Cipla, Lupin, Sun Pharma for commercialisation of COVID-19 drug baricitinib]]> https://biospectrumindia.com/news/95/18597/lilly-inks-agreement-withcipla-lupin-sun-pharma-for-commercialisation-of-covid-19-drug-baricitinib.html https://biospectrumindia.com/news/95/18597/lilly-inks-agreement-withcipla-lupin-sun-pharma-for-commercialisation-of-covid-19-drug-baricitinib.html Mon, 10 May 2021 12:10:00 +0530 Eli Lilly and Company has announced that it has issued royalty-free, non-exclusive voluntary licenses to established Indian pharmaceutical manufacturers of generic medicines, Cipla Ltd, Lupin Ltd and Sun Pharmaceutical Industries Ltd, who are collaborating with Lilly to accelerate and expand the availability of baricitinib in India. Lilly is also in discussions with several other Indian manufacturers for the potential grant of additional voluntary licenses. These voluntary licensing agreements will ensure high quality manufacturing and accessibility of baricitinib during this pandemic improving the local treatment options available to positively impact the lives of people who are currently battling COVID-19 in India.  Lilly has recently received permission for restricted emergency use by the Central Drugs Standard Control Organization (CDSCO), Ministry of Health, for baricitinib to be used in combination with remdesivir for the treatment of suspected or laboratory confirmed COVID-19 in hospitalised adults requiring supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO).  Commenting on the development, Luca Visini, Managing Director, India Subcontinent, Lilly India, said, “During the current surging COVID-19 pandemic, we have responded by issuing three voluntary licenses for baricitinib by pharmaceutical companies in India to accelerate its local manufacturing and distribution under best quality conditions. More licenses to additional Indian generic manufacturers are expected to be announced soon.” Lilly is working closely with the Government in India to defeat the pandemic via different initiatives including donations and expanding availability of Lilly therapies in private or public markets. Meanwhile Lilly continues to engage in active dialogue with the regulatory authorities and government in India to donate Lilly’s anti-COVID-19 treatments, including Lilly’s neutralising antibodies (bamlanivimab and bamlanivimab and etesevimab to be administered together). ]]> <![CDATA[GOQii launches 'Vital 4' to monitor temperature & SPO2 levels]]> https://biospectrumindia.com/news/95/18600/goqii-launches-vital-4-to-monitor-temperature-spo2-levels.html https://biospectrumindia.com/news/95/18600/goqii-launches-vital-4-to-monitor-temperature-spo2-levels.html Mon, 10 May 2021 12:10:00 +0530 GOQii has announced the launch of ‘GOQii Vital 4’, the latest addition to its smart watch category. GOQii Vital 4 is a one-of-its-kind device that will give real-time updates of variation in blood oxygen levels and temperature levels even while you are sleeping thus helping you wake up to a good and stress-free day. With the smartwatch, an individual can immediately get a sense of changes in their vitals and co-relate to a bigger health problem. According to medical experts, COVID-19 patients are found to have lower oxygen rate, hence the device is crucial in diagnosing and monitoring basic COVID-19 symptoms like temperature and SPO2 levels. The perfect combination of tracking body temperature and oxygen rate will help in immediate tracking of potential cases.  Vishal Gondal, Founder and CEO, GOQii said, “With the immense burden that the health workers are under, it falls upon us to take necessary steps to identify early symptoms of COVID-19 leading to timely diagnosis and treatment. Taking essential precautionary measures will prove beneficial in terms of long-term health impacts. Our team has worked tirelessly to launch GOQii Vital 4 that will prove to be a true partner in our battle against COVID-19.” GOQii Vital 4 will be available for order from the GOQii app and is available on online platforms like Amazon and Flipkart. It is recommended that it be used for screening purposes only. All data collected by GOQii is subjected to HIPAA, GDPR and relevant data privacy guidelines. GOQii Vital 4 is priced in India at Rs 4999. ]]> <![CDATA[HealthCube enables distribution of medical oxygen cylinders, concentrators]]> https://biospectrumindia.com/news/95/18592/healthcube-enables-distribution-of-medical-oxygen-cylinders-concentrators.html https://biospectrumindia.com/news/95/18592/healthcube-enables-distribution-of-medical-oxygen-cylinders-concentrators.html Mon, 10 May 2021 00:00:00 +0530 HealthCube, a point-of-care technology-enabled diagnostics service provider, will now enable distribution of medical oxygen cylinders and concentrators under an initiative called OxygenForIndia. The company is the distribution partner in this initiative started by a group of individuals and organizations from a variety of backgrounds to raise funds for the cause. Currently operating out of Delhi, it will be expanded across Kolkata, Ranchi, Guwahati, Chennai, Hyderabad and Bengaluru in the days to come. Through OxygenForIndia.Org, the aim is to raise $1,200,000 for providing 3,500 cylinders and 700 concentrators to those who need it the most. Within seven days after it was initiated, OxygenForIndia has received $500,000 in contributions. Around 50 medical oxygen cylinders were delivered to patients in Delhi and 50 oxygen cylinders are on their way.  Speaking about this, Dr Ramanan Laxminarayan, Founder, HealthCube and OxygenForIndia, said, “Some days ago, one of my colleagues nearly died due to lack of oxygen. The resultant anguish and the rush to arrange things made me realize that COVID-19 and the lack of oxygen is something that affects every one of us. Since there is no organized arrangement to supply oxygen concentrators and cylinders. This is why we decided to step in and founded OxygenForIndia and raising funds. We raised funds for 2500 cylinders and concentrators. I am pleased to say that we have been able to make good progress and aim to raise the required funds to support the supply of oxygen in these dire times.“ ]]> <![CDATA[J B Chemicals forays into nephrology segment in India]]> https://biospectrumindia.com/news/95/18577/j-b-chemicals-forays-into-nephrology-segment-in-india.html https://biospectrumindia.com/news/95/18577/j-b-chemicals-forays-into-nephrology-segment-in-india.html Thu, 06 May 2021 14:00:00 +0530 J.B. Chemicals & Pharmaceuticals, based in Mumbai, has announced its foray into the area of Nephrology with a new dedicated division called “RENOVA” which will endeavour to serve patients who are under treatment for Chronic Kidney Disease. The new division will focus exclusively on comprehensive renal care ranging from the management of hypertension in Chronic Kidney Disease to End-stage renal disease. After successfully becoming one of the leading player in Hypertension with brands like Cilacar® and Nicardia® , JBCPL has now begun to also focus on patients with CKD. With the introduction of this new division and patient-centric initiatives, JBCPL can help address the medical needs of patients with CKD. The launch of this division will also enable nephrologists and physicians to provide patients with different treatment options and ultimately improve the quality of life in these patients. JBCPL will continue to launch products under this division to achieve its objective of providing holistic support to CKD patients at every stage. “Being one of leaders in the hypertension segment, we realised that Chronic Kidney Disease is a major issue in the country and the numbers are rising significantly.  There are growing cases of hypertension associated with CKD and we believe this initiative will enable us service the growing unmet needs of CKD patients”, said Nikhil Chopra, CEO & Whole Time Director, J.B. Chemicals & Pharmaceuticals Limited. ]]> <![CDATA[ISSAR Pharma to license out peptide-based NCEs]]> https://biospectrumindia.com/news/95/18573/issar-pharma-to-license-out-peptide-based-nces.html https://biospectrumindia.com/news/95/18573/issar-pharma-to-license-out-peptide-based-nces.html Thu, 06 May 2021 00:00:00 +0530 To boost the production of medicines in these tough times of crisis and to fill the gap in the Indian pharma industry, ISSAR Pharmaceuticals, based in Hyderabad, has decided to license out their peptide-based new chemical entities (NCEs), with pre-IND filing and US Patent. The potential collaboration would help ISSAR Pharmaceuticals in their goal to design and deliver novel peptide-based drugs for various unmet healthcare needs of the population, and making it affordable and accessible for better health outcomes.  Ramakrishna Reddy Isanaka, Founder and Chairman, ISSAR Pharmaceuticals, sates, “We take pride in being India’s first ever company to conduct Phase-1 clinical trials, and launch the first ever indigenous peptide drug, Melgain in market for the treatment of Vitiligo in 2004.” ISSAR Pharmaceuticals exclusively focuses on peptide technology-based research and development of new chemical entities (NCE) for various unmet medical needs to improve the quality of life. ISSAR uses Solid-phase peptide synthesis as the technology of choice, and has the capability to synthesise custom peptides, API peptides and cosmetic peptides at all scales within a short duration.  ISSAR’s commitment has also led to the development of their second new chemical entity called Xylentra, which is the first ever peptide drug in the world for the treatment of burn wounds and microbial infections.  ISSAR developed molecules for prevalent conditions in the western world such as inflammatory bowel diseases (IBD), psoriasis and sepsis. Recently, an NCE for the treatment of burn-wounds (Xylentra) was licensed to Viatris, formerly known as Mylan Laboratories, USA in 2020. ]]> <![CDATA[Wipro focuses on transforming vaccine safety assessment]]> https://biospectrumindia.com/news/95/18575/wipro-focuses-on-transforming-vaccine-safety-assessment.html https://biospectrumindia.com/news/95/18575/wipro-focuses-on-transforming-vaccine-safety-assessment.html Thu, 06 May 2021 00:00:00 +0530 Wipro Limited has announced a partnership with Hyderabad based Transcell Oncologics to transform vaccine safety assessment using augmented intelligence (AI). This partnership combines Transcell’s innovative stem cell technology with the advanced augmented intelligence capabilities of Wipro HOLMES® to improve the safety of global vaccine immunization programs. By applying AI to the vaccine development process, our solution is capable of predicting adverse neurovirulent impacts resulting from vaccinations. Currently, vaccine safety assessment often includes testing on animals to measure adverse impacts.  Using Wipro HOLMES® instead, researchers and biopharmaceutical companies have a new and fully viable solution and alternative. Wipro HOLMES® can also be integrated into any existing workflow, including quality control tests in vaccine production, batchwise release and other safety evaluation assays. This partnership will also expand the Wipro HOLMES® solutions available to life science companies. The solution applies AI for drug repurposing and Messenger Ribonucleic Acid (mRNA) based platform for biodefense. It enables the testing of new vaccines by applying augmented intelligence to stem cell research and measuring safety and potency. This is the first in a series of next generation solutions that the partnership will offer to determine the safety and efficacy of a wide-range of products from vaccines to prescription medications, cosmetics and more. ]]> <![CDATA[L&T to deliver 22 oxygen generators to hospitals nationwide]]> https://biospectrumindia.com/news/95/18571/lt-to-deliver-22-oxygen-generators-to-hospitals-nationwide.html https://biospectrumindia.com/news/95/18571/lt-to-deliver-22-oxygen-generators-to-hospitals-nationwide.html Wed, 05 May 2021 16:50:00 +0530 L&T is working towards a long-term solution to meet the medical-grade oxygen demand in the country. L&T will soon start delivering 22 oxygen generators to various hospitals in India, where the scarcity is most acute. These units will absorb air from the atmosphere before converting it into medical-grade oxygen and pumping it into pre-existing pipes in the hospitals. Of these, the parts of the first tranche of nine equipment will reach India by May 9. These will be progressively delivered from May 15 to hospitals that are in acute need and do not possess required infrastructure to receive bulk oxygen supply. L&T CEO & MD, SN Subrahmanyan, said, “Our teams in India and abroad have, with single-minded attention in the last few days, been able to procure the oxygen generators and other components to assemble PSA units. Together we shall all overcome the COVID-19 scourge.” L&T is sourcing the components from various parts of the world. Once assembled at L&T’s Hazira Manufacturing Complex, each part will be compact, stand-alone oxygen-making units. After testing, they will be dispatched to various hospitals where they will immediately start producing medical-grade oxygen as per the requirements. Each unit has a compressor, dryer, oxygen generator and two storage tanks that could cater to hospitals or medical facilities with over 1,750 beds. The units work on the plug-and-play principle. Once all the constituent parts are fabricated, the compressor allows the air to reach a particular pressure within a few minutes. The generator then starts pumping oxygen into pipes. Each of the units has a capacity range from 1,000 litres per minute (LPM) to 500 LPM. A 1,000 LPM machine could service 100-plus beds simultaneously. The 500 LPM machine can potentially service 50-plus beds at any point of time. These permanent units will serve the hospitals for the next 10-15 years.   ]]> <![CDATA[Eli Lilly accelerates Baricitinib’s availability in India to fight COVID-19]]> https://biospectrumindia.com/news/95/18570/eli-lilly-accelerates-baricitinibs-availability-in-india-to-fight-covid-19.html https://biospectrumindia.com/news/95/18570/eli-lilly-accelerates-baricitinibs-availability-in-india-to-fight-covid-19.html Wed, 05 May 2021 16:00:00 +0530 Eli Lilly and Company has announced new initiatives to help COVID-19 patients in India as part of its commitment to bring the full force of its scientific and medical expertise to attack the coronavirus pandemic around the world. Lilly is offering donations of baricitinib to the Indian government through Direct Relief while simultaneously working with several local Indian pharmaceutical companies to execute royalty-free voluntary licensing agreements to accelerate the manufacturing and distribution of the medicine in India during the pandemic. Lilly has received permission for restricted emergency use from Central Drugs Standard Control Organization, for baricitinib (2 mg and 4 mg) in combination with remdesivir, for treatment of suspected or laboratory confirmed COVID-19 in hospitalized adults requiring supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation (ECMO). Baricitinib is an oral medication currently registered in India for the treatment of moderate to severe active rheumatoid arthritis in adult patients who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs. ]]> <![CDATA[Impelsys spins off healthcare venture & rebrands to MedLern]]> https://biospectrumindia.com/news/95/18567/impelsys-spins-off-healthcare-venture-rebrands-to-medlern.html https://biospectrumindia.com/news/95/18567/impelsys-spins-off-healthcare-venture-rebrands-to-medlern.html Wed, 05 May 2021 10:10:00 +0530 Impelsys, a Bengaluru based cloud platform for e-books and e-learning, has announced that it is spinning off its venture iPC Health into a separate entity. iPC Health, launched in January 2020, is a digital platform dedicated to serving Hospitals and Healthcare professionals with a comprehensive set of learning and training solutions. The company simultaneously announced the appointment of Deepak Sharma as the CEO of the new venture and unveiled MedLern - the new brand which will represent the platform. From January 2020, when Impelsys launched iPC Health, the need for digital learning and training in hospitals has only become more acute. The looming shortage of skilled healthcare workers will need scalable solutions and platforms to meet immediate and future needs of the country. The MedLern platform has been implemented as a learning partner in more than 130 hospitals and 30,000 healthcare professionals with leading providers like CloudNine, KIMSHEALTH, Yenepoya Hospitals, Meitra Hospital, MS Ramaiah, Sparsh, Dr. Mehta’s Children Hospital placing their trust in the platform. Recently, MedLern announced its partnership with RCNi, a subsidiary of the Royal College of Nursing UK to bring leading peer reviewed and research based CPD Certificate programs to Indian Hospitals. ]]> <![CDATA[Natco Pharma to launch Baricitinib tablets for COVID-19 treatment]]> https://biospectrumindia.com/news/95/18560/natco-pharma-to-launch-baricitinib-tablets-for-covid-19-treatment.html https://biospectrumindia.com/news/95/18560/natco-pharma-to-launch-baricitinib-tablets-for-covid-19-treatment.html Tue, 04 May 2021 10:00:00 +0530 Natco Pharma has received Emergency Use (EU) approval for Baricitinib tablets, 1mg, 2mg and 4mg strengths from Central Drugs Standard Control Organization (CDSCO) in India. Baricitinib in combination with Remdesivir is used for treatment of COVID-19 positive patients. Hyderabad based Natco will be requesting a Compulsory License based on emergency use and in light of the grave and serious public health emergency across India due to the pandemic. The company is ready to launch the product this week, so as to make the product available to suffering patients across India. Baricitinib is an orally available small molecule inhibitor of Janus kinases that is used to treat moderate-to-severe rheumatoid arthritis. ]]> <![CDATA[Mankind Pharma onboards Accenture for digital transformation]]> https://biospectrumindia.com/news/95/18561/mankind-pharma-onboards-accenture-for-digital-transformation.html https://biospectrumindia.com/news/95/18561/mankind-pharma-onboards-accenture-for-digital-transformation.html Tue, 04 May 2021 09:05:00 +0530 New Delhi based Mankind Pharma has collaborated with Accenture to accelerate its digital transformation journey to become an intelligent enterprise, improving business agility, performance, and operational efficiency. Accenture has redesigned the pharma major’s business processes across key functions such as finance, supply chain, sales and procurement for better inventory optimisation, demand planning, workforce productivity and product availability. As part of the project, Accenture deployed a digital platform based on SAP S/4HANA®, a Microsoft Azure cloud-based data lake and Tableau dashboards, providing cloud-based analytics to help Mankind Pharma get deeper insights into its global business operations and performance. The platform integrates data in real-time from multiple sources across the supply chain, workforce and sales to provide a consolidated view of market insights. This can help the management team make informed decisions around business strategy, planning and product development. “At Mankind Pharma, we are committed to product innovation so we can provide high quality and affordable pharmaceutical products to people across the world,” said Arjun Juneja, chief operating officer, Mankind Pharma. “Digitally transforming our business processes with support from Accenture has been key to unlocking value trapped within the organization, accelerating real time decision making, and improving our product innovation lifecycle.” ]]> <![CDATA[ABCD Technologies onboards new partners to boost pharma supply chain]]> https://biospectrumindia.com/news/95/18557/abcd-technologies-onboards-new-partners-to-boost-pharma-supply-chain.html https://biospectrumindia.com/news/95/18557/abcd-technologies-onboards-new-partners-to-boost-pharma-supply-chain.html Mon, 03 May 2021 16:20:00 +0530 ABCD Technologies LLP (to be renamed as IndoHealth Services LLP) has announced that nine new partners have joined the initiative aimed at developing a world-class pharmaceutical supply chain & distribution IT ecosystem in India. The new partners include Glenmark Pharmaceuticals Ltd, Emcure Pharmaceuticals Ltd, USV Private Ltd, Micro Labs Ltd, Alembic Pharmaceuticals Ltd, Cadila Pharmaceuticals Ltd, Ajanta Pharma Ltd, Ipca Laboratories Ltd and Intas Pharmaceuticals Ltd. With the addition of new partners, ABCD Technologies LLP now has 17 partners. The companies who had joined earlier included Alkem Laboratories Ltd, Zydus HealthCare Ltd, Cipla Ltd, Dr Reddy’s Laboratories Ltd, Lupin Ltd, Mankind Pharma Ltd, Sun Pharma Distributors Ltd and Torrent Pharmaceuticals Ltd. The partnership is aimed at digitising the pharmaceutical supply chain for improving the availability & accessibility of medicines and it supports the government’s National Digital Health Mission (NDHM). Earlier in April, DigiHealth Technologies LLP had acquired AIOCD Pharmasofttech AWACS Private Limited (AWACS) and Pharmarack Technologies Private Limited (Pharmarack). The initiative has been supported by Transaction Square.   ]]> <![CDATA[Glenmark launches nasal spray in India for treating allergic rhinitis]]> https://biospectrumindia.com/news/95/18554/glenmark-launches-nasal-spray-in-india-for-treating-allergic-rhinitis.html https://biospectrumindia.com/news/95/18554/glenmark-launches-nasal-spray-in-india-for-treating-allergic-rhinitis.html Mon, 03 May 2021 13:00:00 +0530 Glenmark Pharmaceuticals Limited, a research-led, global integrated pharmaceutical company, announced the launch of Ryaltris®-AZ Nasal Spray for the treatment of moderate to severe allergic rhinitis, in India. Glenmark being one of the leaders in respiratory segment, has been the first to launch the branded generic version at an affordable cost for the treatment of allergic rhinitis in India. This will provide patients a far more convenient, cost effective treatment option in the country. Mumbai based Glenmark is the first company in the world to launch Ryaltris®-AZ, as a novel fixed dose combination of Mometasone furoate 50 mcg + Azelastine 140 mcg. Ryaltris®-AZ nasal spray, developed by Glenmark, is a novel fixed-dose combination nasal spray of an antihistamine and a steroid, indicated for treatment of symptoms associated with allergic rhinitis (AR) in patients over 12 years of age. It relieves symptoms of allergic rhinitis, including stuffy nose, runny nose, nasal itching, sneezing, as well as itchy, red and watery eyes. Alok Malik, Group Vice President & Business Head, India Formulations said “Glenmark has been a pioneer in providing access to the latest treatment options for respiratory disease patients in India. We are glad to introduce our brand Ryaltris®-AZ, which is clinically studied and cutting-edge, at an affordable cost for patients in the country. Respiratory segment is a key area of focus for Glenmark and the launch of this product will enable us to improve access to allergic rhinitis treatment by providing an effective, convenient, world-class and affordable treatment option to patients in India.” ]]> <![CDATA[Dr Reddy's to start rolling-out Sputnik V in few days]]> https://biospectrumindia.com/news/95/18550/dr-reddys-to-start-rolling-out-sputnik-v-in-few-days.html https://biospectrumindia.com/news/95/18550/dr-reddys-to-start-rolling-out-sputnik-v-in-few-days.html Mon, 03 May 2021 09:05:00 +0530 Hydrabad based Dr Reddy’s Laboratories has announced that the first consignment of 150,000 doses of the Sputnik V vaccine has landed in Hyderabad from Russia. The roll-out of the consignment will be subject to the necessary clearances, which will be processed over the next few days. This initial quantity will be used across different channels as a pilot to line up our supply chain for the larger vaccination program rollout. Subsequent consignments will arrive in the next few weeks. "This is a reaffirmation of Dr Reddy’s commitment towards combating COVID-19 in India through our portfolio of therapeutics and vaccines", said Deepak Sapra, CEO – API and Services, Dr Reddy’s Laboratories. ]]> <![CDATA[Covishield, Covaxin prices come down to Rs 300, Rs 400]]> https://biospectrumindia.com/news/95/18541/covishield-covaxin-prices-come-down-to-rs-300-rs-400.html https://biospectrumindia.com/news/95/18541/covishield-covaxin-prices-come-down-to-rs-300-rs-400.html Thu, 29 Apr 2021 20:00:00 +0530 Pune based Serum Institute of India (SII) has brought down the price of Covishield vaccine for COVID-19 from Rs 400 to Rs 300, as a philanthropic gesture. "I hereby reduce the price to the states from Rs.400 to Rs.300 per dose, effective immediately; this will save thousands of crores of state funds going forward. This will enable more vaccinations and save countless lives", tweeted Adar Poonwalla, CEO, SII, on April 28th. Soon after this announcement, Hyderabad based Bharat Biotech has also brought down the price of Covaxin, from Rs 600 to Rs 400. "We wish to be transparent in our approach to pricing which was determined by internally funded product development, several operationally intensive BSL-3 manufacturing facilities and clinical trials. Recognising the enormous challenges to the public healthcare system, we have made Covaxin available to state governments at a price of Rs 400/dose", as stated on the company's twitter handle, on April 29th. ]]> <![CDATA[Linde India working towards meeting medical oxygen demands across India ]]> https://biospectrumindia.com/news/95/18537/linde-india-working-towards-meeting-medical-oxygen-demands-across-india-.html https://biospectrumindia.com/news/95/18537/linde-india-working-towards-meeting-medical-oxygen-demands-across-india-.html Thu, 29 Apr 2021 16:20:00 +0530 Linde India and Praxair India are working on several large-scale initiatives in cooperation with the Government of India, relevant authorities, and industry partners at a national level as existing supply chains are under enormous pressure in meeting the huge demand, especially to the most impacted parts of the nation for medical oxygen. Linde in India has embarked on two major operations. The company is working closely with the Indian Railways for its Roll-On-Roll-Off (RO-RO) service for faster transportation of medical oxygen to most critical need areas.  Secondly, Linde is collaborating with its operations in the Asia Pacific, including in Singapore, China and Thailand, as well as various Indian industry partners to transport ISO cryogenic tankers from across the region to India. These containers can carry up to 20 tonnes of liquid oxygen over long distances, and upon arrival the containers will be conditioned and certified for liquid medical oxygen transport from Linde facilities. The tankers can also act as interim oxygen storages in remote areas that are facing oxygen scarcity.   Currently eight containers have arrived in India and many more are expected to over the next few weeks.   Linde India and Praxair India Pvt Ltd collectively manage and operate several plants with air separation and manufacturing capabilities. These plants currently have a combined capacity of more than 2000 metric tonnes per day (MTPD) and are located across India. Both the companies are also converting their liquid nitrogen and liquid argon tankers to augment the oxygen transportation capacities.  Linde India and Praxair India Pvt Ltd have also fast-tracked installation works at partner hospitals to ease oxygen supply challenges there. Among others, they have recently installed a 20 KL tank at GMERS Medical College, Junagadh, Gujarat. GMERS Medical College, Junagadh and another 20 KL tank at Sanjay Gandhi Post Graduate Institute, Lucknow.  Moloy Banerjee, Head Gases - South Asia, Linde South Asia Services Private Limited said, “All possible efforts are being undertaken to address supply and transportation challenges and we are thankful to our international counterparts and industry partners such as the ITC Group, Tata Group and many more such organisations that are coming forward to lend their support in executing these initiatives.”  ]]> <![CDATA[Roche Pharma ramps up production of Tocilizumab for COVID-19 treatment]]> https://biospectrumindia.com/news/95/18532/roche-pharma-ramps-up-production-of-tocilizumab-for-covid-19-treatment.html https://biospectrumindia.com/news/95/18532/roche-pharma-ramps-up-production-of-tocilizumab-for-covid-19-treatment.html Thu, 29 Apr 2021 09:00:00 +0530 Roche Pharma has observed an unprecedented demand for Tocilizumab (Actemra) given the significant increase in Covid cases across India in the last few weeks. The company responding to this situation with supplies over this and the coming weeks to meet the immediate emergency demand. "However, we are mindful that the current unprecedented demand may far exceed the supplies we can provide at this moment", as stated by the company Roche is working urgently to increase manufacturing capacity and supply by ramping up  production network, as well as actively collaborating with external partners to maximize production of Actemra wherever possible with the goal of increasing its availability. This should enable to meet future demand in a fluid and hard to predict environment. With the increasing number of infections in India, minimizing hospitalizations and easing pressure on healthcare systems is particularly important. This is where neutralizing antibody cocktails may play a role in the fight against COVID-19, in the treatment of high-risk patients before their condition worsens.  Roche Pharma is working with local health authorities to accelerate an emergency use authorization (EUA) for its investigational antibody cocktail Casirivimab and Imdevimab in India (based on the data that have been filed for the EUA in the US and the CHMP scientific opinion in the EU). An emergency use authorization in India would enable the import of globally manufactured product batches to India as soon as possible. ]]> <![CDATA[Cipla to commercialise Molnupiravir for COVID-19 treatment ]]> https://biospectrumindia.com/news/95/18530/cipla-to-commercialise-molnupiravir-for-covid-19-treatment-.html https://biospectrumindia.com/news/95/18530/cipla-to-commercialise-molnupiravir-for-covid-19-treatment-.html Wed, 28 Apr 2021 16:25:00 +0530 Cipla Limited announced that it has signed a non-exclusive licensing agreement with MSD a tradename of Merck & Co, Inc, Kenilworth, NJ, US for the manufacturing and distribution of Molnupiravir, the investigational oral antiviral drug currently being studied in a Phase 3 trial for the treatment of non-hospitalised patients with confirmed COVID-19.  MSD is developing Molnupiravir in collaboration with Ridgeback Biotherapeutics. This agreement is a part of Cipla’s efforts to enhance global access to treatments for patients affected by the pandemic. As part of the agreement, Cipla will be permitted to manufacture, market and distribute Molnupiravir in India and more than 100 low and middle income countries. Cipla’s extensive geographical and commercial footprint will help make this therapy accessible to more patients and markets. Molnupiravir (EIDD-2801/MK-4482) is an investigational, orally bioavailable form of a potent ribonucleotide analog that inhibits the replication of multiple RNA viruses including SARS-CoV-2, the causative agent of COVID-19. Molnupiravir has been shown to be active in several models of SARS-CoV-2, including for prophylaxis, treatment and prevention of transmission, as well as SARS-CoV-1 and MERS. EIDD-2801 was invented at Drug Innovations at Emory (DRIVE), LLC, a not-for-profit biotechnology company wholly owned by Emory University. Commenting on the partnership, Umang Vohra, MD and Global CEO, Cipla Limited, said, “We are pleased to partner with MSD for this cause and take this treatment to patients across countries. In keeping with our purpose of Caring for Life, this collaboration will expand patient access to quality treatment for COVID-19.” ]]> <![CDATA[MSN Labs launches Favilow (Faripiravir) 800mg tablets to fight COVID-19]]> https://biospectrumindia.com/news/95/18525/msn-labs-launches-favilow-faripiravir-800mg-tablets-to-fight-covid-19.html https://biospectrumindia.com/news/95/18525/msn-labs-launches-favilow-faripiravir-800mg-tablets-to-fight-covid-19.html Wed, 28 Apr 2021 12:00:00 +0530 In order to address the shortage of the antiviral drug, Faripiravir to treat mild and moderate COVID-19 flu, Hyderabad based MSN Laboratories, have announced the launch of its branded generic, Favilow 800 mg. The higher strength Favilow 800 mg is priced at Rs 144 per tablet and will be available across pharmacies. The field team of MSN Labs is also helping out with free home delivery in over 170 cities in coordination with local retail chemists for patient convenience. Dr MSN Reddy, CMD – MSN Group said, “In the light of increasing COVID-19 cases in India, affordable treatment options are the need of the hour to flatten the curve. We are sure that our product Favilow 800 would help support the nation’s efforts in overcoming the COVID crisis.” MSN had launched the world’s most affordable branded generic of Favipiravir, Favilow, in August last year, in the strengths of 200 and 400 mg. MSN claims the higher strength will improve patient compliance and experience by effectively reducing the number of tablets a patient requires per day. The launch would also address the shortages and issues faced by the patients in procuring the COVID-19 drug. The higher strength of Favipiravir 800 mg from MSN has been approved by the Drug Controller General of India (DCGI). MSN successfully developed the active pharmaceutical ingredient (API) and the formulation for FAVILOW 800 mg in its in-house R&D and manufacturing units.  ]]> <![CDATA[Syngene extends drug discovery research collaboration with BMS until 2030]]> https://biospectrumindia.com/news/95/18516/syngene-extends-drug-discovery-research-collaboration-with-bms-until-2030.html https://biospectrumindia.com/news/95/18516/syngene-extends-drug-discovery-research-collaboration-with-bms-until-2030.html Wed, 28 Apr 2021 00:00:00 +0530 Bengaluru based Syngene International has announced that it has extended its ongoing research collaboration with Bristol Myers Squibb (BMS). The collaboration has been extended through the end of 2030 and will expand the breadth of drug discovery research conducted, including chemistry, biology, drug metabolism and pharmacokinetics, as well as translational medicine research and pharmaceutical development, including chemical process development and analytical sciences, in the coming years. The extension envisions a 40% increase in the number of scientists and the addition of a new 50,000 sq. ft. dedicated laboratory space.   Jonathan Hunt, MD and CEO, Syngene International Ltd., said, "For more than twenty years we have considered our work with Bristol Myers Squibb to set the benchmark for integrated research collaborations and are delighted with our joint commitment to extend this collaboration until at least the end of the decade, as well as expand our focus to new areas of science. I have every confidence that together we will continue to deliver science that will improve the lives of patients around the world." Gregory Vite, Ph.D., Senior Vice President, Small Molecule Drug Discovery, Bristol Myers Squibb, said, "We greatly value our collaboration with Syngene International and are proud to extend and expand our work together. The dedicated facilities and scientific team at Syngene play an important role in helping us realize our vision to transform patients’ lives through science.” Syngene and Bristol Myers Squibb's collaboration dates back to 1998 and the dedicated Biocon BMS Research and Development Center (BBRC), Syngene's first dedicated R&D Center, was fully commissioned in 2009. Over many years of collaboration, the BBRC has become a major strategic R&D site for Bristol Myers Squibb. ]]> <![CDATA[DetelPro launches economical oximeter at Rs 799]]> https://biospectrumindia.com/news/95/18521/detelpro-launches-economical-oximeter-at-rs-799.html https://biospectrumindia.com/news/95/18521/detelpro-launches-economical-oximeter-at-rs-799.html Tue, 27 Apr 2021 18:35:00 +0530 DetelPro, the health and hygiene vertical of Detel, has announced its oximeter DI-OXY10 is for Rs 799 plus GST only. Detel’s oximeter is based on all digital technology and intended for non-invasive measurement of functional oxygen saturation. Commenting on the same, Dr Yogesh Bhatia, Founder, Detel, said, “We aim to remedy expensive medical bills and serve our customers with nothing but the best in class medical equipment. Our Detel oximeter will help a lot of people as there is an immediate need to amplify the supply of oxygen as well as equipment required for patients’ care not only at home but also in hospitals. We all are very well aware of the current nightmare and therefore this will definitely prove to be a major help. We join hands with the government and are ready to serve the nation by introducing our cost-effective oximeter.”  ]]> <![CDATA[Sleepwell donates 500 bedding units to India’s largest COVID-19 facility]]> https://biospectrumindia.com/news/95/18520/sleepwell-donates-500-bedding-units-to-indias-largest-covid-19-facility.html https://biospectrumindia.com/news/95/18520/sleepwell-donates-500-bedding-units-to-indias-largest-covid-19-facility.html Tue, 27 Apr 2021 16:10:00 +0530 Sleepwell, mattress brand from Sheela Foam Ltd, has once again risen to the occasion to support healthcare efforts across the country. Continuing its partnership with the government, Sleepwell has donated 500 bedding units to India’s largest COVID-19 facility. The bedding units comprise of mattresses, pillows and beds with a back-rest that is especially designed for patients that require oxygen. The company had helped set up the facility last year with a donation of 10,000 bedding units. Operated by Indo-Tibetan Border Police (ITBP), The Sardar Patel COVID Care Centre is now open for COVID-19 affected patients. Commenting on the initiative, Rahul Gautam, Managing Director, Sheela Foam Ltd said, “As the COVID-19 situation worsens in India, it is upon each and everyone of us to step up and support the healthcare infrastructure and the Corona warriors in our own small ways. Currently we had added 500 bedding units at The Sardar Patel COVID Care Centre and will continue to support with any further requirements.” The mattresses and beds have been specially created for the purpose of quarantining, hence are comfortable to sleep and sit on for long durations of time. The Healthmat mattress is made using a proprietary foam core for comfort and support, designed for long hours of sleeping & sitting. All these mattresses come with a special cover for easy wiping and sanitising. They are also treated with the patented Neem Fresche technology that ensures zero allergens & germs. The specially designed Envirobed can be assembled in under five minutes, is made of 100 per cent natural and recyclable corrugated hardboard, at the same time is water resistant and can be fully sanitised. The bed is light weight and portable yet has the ability to take more than 250 kg. ]]> <![CDATA[MSD widens access to molnupiravir in India]]> https://biospectrumindia.com/news/95/18518/msd-widens-access-to-molnupiravir-in-india.html https://biospectrumindia.com/news/95/18518/msd-widens-access-to-molnupiravir-in-india.html Tue, 27 Apr 2021 14:00:00 +0530 MSD Pharmaceuticals, a wholly owned subsidiary of Merck Sharp & Dohme and known as Merck & Co., Inc., in the United States and Canada, has announced that the company has decided to enter into non-exclusive voluntary licensing agreements for molnupiravir with five established Indian generic manufacturers. Molnupiravir is an investigational oral antiviral agent currently being studied in a Phase 3 trial for the treatment of non-hospitalized patients with confirmed COVID-19. MSD is developing molnupiravir in collaboration with Ridgeback Biotherapeutics. MSD has entered into these agreements to accelerate availability of molnupiravir in India and in other low- and middle-income countries (LMICs) following approvals or emergency authorization by local regulatory agencies. The agreements have been signed with CIPLA Limited, Dr REDDY’s Laboratories Limited, EMCURE Pharmaceuticals Limited, HETERO Labs Limited and SUN Pharmaceutical Industries Limited – five generics manufacturers with World Health Organization (WHO) Pre-Qualified Manufacturing facilities and experience as major suppliers to global and key LMIC procurers. Under the agreements, Merck & Co., Inc., US will provide licenses to these manufacturers to supply molnupiravir to India and more than 100 LMICs. Merck & Co., Inc., US is also in discussions with the Medicines Patent Pool to explore the potential for additional licenses. “Through partnerships with established Indian generics manufacturers, we are reinforcing our commitment towards expanding access to molnupiravir in India,” said Rehan A Khan, Managing Director, MSD-India Region. “We look forward to collaborating with these partners and supporting them in advancing our mission of improving lives.  We are in talks with the Government and other key stakeholders as we remain committed to expanding equitable access to medicines and bringing innovative treatments to the country.” ]]> <![CDATA[Gilead Sciences expands availability of Remdesivir in India]]> https://biospectrumindia.com/news/95/18515/gilead-sciences-expands-availability-of-remdesivir-in-india.html https://biospectrumindia.com/news/95/18515/gilead-sciences-expands-availability-of-remdesivir-in-india.html Tue, 27 Apr 2021 10:00:00 +0530 Gilead Sciences, Inc. has announced that in response to the rapid increase in COVID-19 cases in India, the company is providing its voluntary licensing partners with technical assistance, support for the addition of new local manufacturing facilities and the donation of active pharmaceutical ingredient (API) to rapidly scale up production of remdesivir. Remdesivir is approved in India for restricted emergency use for the treatment of suspected or laboratory confirmed COVID-19 in adults and children hospitalized with severe disease. In addition to providing support to its licensees to expand their local manufacturing capacity, Gilead will also donate at least 450,000 vials of Veklury® (remdesivir) to help address the immediate needs of Indian patients. All seven of Gilead’s licensees based in India have significantly accelerated production of remdesivir by scaling up their batch sizes, adding new manufacturing facilities and/or onboarding local contract manufacturers across the country. While these efforts are expected to increase availability of remdesivir in the coming weeks, Gilead will donate at least 450,000 vials of Veklury to the Government of India to help ease the immediate need for treatment. To safeguard against disruption of generic remdesivir supply to other low- and middle-income countries included as part of the voluntary licenses, Gilead is also committed to providing support to voluntary licensees based outside of India to increase their production capacity. Gilead’s planned support will include the donation of API to licensees with a view to accelerate production. ]]> <![CDATA[Mankind Pharma launches toilet seat disinfectant spray]]> https://biospectrumindia.com/news/95/18510/mankind-pharma-launches-toilet-seat-disinfectant-spray.html https://biospectrumindia.com/news/95/18510/mankind-pharma-launches-toilet-seat-disinfectant-spray.html Mon, 26 Apr 2021 15:15:00 +0530 Mankind Pharma has launched a toilet seat disinfectant spray under its new brand Safekind. The product is mainly for females and provides a solution for easy usage of unhygienic toilets, specially while using public toilets. The purpose behind launching Safekind toilet seat disinfectant spray, is to prevent urinary tract infections (UTIs), which is becoming a common concern among women. The infection involves greater risk when one uses public washrooms that are often unclean and unhygienic. With the launch of Safekind toilet seat disinfectant spray, the motive to reduce the chances of getting UTIs and ensuring the usage of public toilets is safe. The product contains IPA (isopropyl alcohol – 10 per cent w/w), BKC (Benzalkonium chloride) which kills 99.9 per cent germs, helps to provide a fresh, clean & germ-free toilet experience. Talking about the new product launch, Joy Chatterjee, General Manager, Sales and Marketing, Mankind Pharma said, “We are delighted to come up with a new product under Safekind as the world is battling with health emergencies and need to sanitise and ensure cleanliness in all places. Seeing the spike in hygiene and urine infection problems faced by women, we took the initiative to serve the nation by protecting our community.”  Safekind toilet seat disinfectant spray with soothing and refreshing smell comes in a handy packaging of 75 ml at Rs 200 which is easy to carry while travelling.     ]]> <![CDATA[PharmEasy launches COVID-19 vaccination drive with aim to vaccinate over three crore people]]> https://biospectrumindia.com/news/95/18509/pharmeasy-launches-covid-19-vaccination-drive-with-aim-to-vaccinate-over-three-crore-people.html https://biospectrumindia.com/news/95/18509/pharmeasy-launches-covid-19-vaccination-drive-with-aim-to-vaccinate-over-three-crore-people.html Mon, 26 Apr 2021 14:40:00 +0530 PharmEasy launched the biggest COVID-19 vaccination drive in the country. With this drive, the company aims to vaccinate over three crore people via camps and vaccine centres. Individuals, companies, RWAs, old age homes etc can register for vaccines that will be administered. Leveraging its presence across India, with over 80,000 partner retailers, 5,000 doctors and a state-of-the-art pharma supply chain facility enabling last-mile delivery of cold chain products, the company aims to vaccinate over three crore families via 5,000 partner centres, pan-India in the next few quarters. Basis the availability of vaccines and guidelines provided by GoI (to be released soon), PharmEasy will release the timelines for the start of the vaccination drive. As soon as the vaccines doses are available, the company will reach out to registered individuals and assist them with vaccination slots at camps set-up in their vicinity. PharmEasy has already received an overwhelming response, with over 50 lakh individuals and 1200 organisations across the length and breadth of the country, making a soft commitment to vaccinate themselves and their respective families.  Speaking about the vaccination drive, Dharmil Sheth, Co-founder, PharmEasy said, “Our vaccination drive aims to provide ease of access to vaccination which can help us to achieve herd immunity at the earliest. Amidst the rising COVID-19 cases in the second wave, we wanted to contribute our bit in breaking the chain by setting up vaccination camps and centres to facilitate this.”   ]]> <![CDATA[Kemwell Biopharma augments existing CDMO infrastructure]]> https://biospectrumindia.com/news/95/18512/kemwell-biopharma-augments-existing-cdmo-infrastructure.html https://biospectrumindia.com/news/95/18512/kemwell-biopharma-augments-existing-cdmo-infrastructure.html Mon, 26 Apr 2021 14:00:00 +0530 Bengaluru based Kemwell Biopharma, a biologics contract development and manufacturing service provider, has recently augmented its existing infrastructure. As part of this expansion strategy, the company has installed Ambr® 250, a high throughput equipment with 12 fully automated mini bioreactors at a 250 ml scale to accelerate process development. Ambr® 250 enables  setting of 12 different media conditions, temperatures and gases, helping the client projects  identify the most optimal process leading to higher titer while reducing the cost per experiment and thereby enhancing in-lab productivity. In addition to Ambr® 250 , 3 more 5 L scale glass bioreactors are installed and now houses a total of 12 bioreactors of 5 and 10L scale. The company is also looking forward to meeting the demand of its customers by expanding its manufacturing capacity further by adding three Single-Use Bioreactors (SUBs) this month. It plans to install 100L (R&D), 200L and 1000L SUBs in its existing cGMP plant to support process scale-up and preclinical toxicology batch and early clinical trial supplies., which are expected to be operational by October 2021. With the above addition, Kemwell will have 5000L of cGMP manufacturing capacity and has a further investment plan to install an additional 12,000L of bioreactor capacity in an existing shell space of 26,000 sq ft for an investment of Rs 1500 Million. Kemwell is exploring strategic partnerships with biopharma players in the ecosystem to fit out this additional capacity which can be executed within 12-15 months. The company offers proven expertise in supporting biotech companies with process development, clinical and commercial manufacturing of monoclonal antibodies, fusion proteins and other mammalian’s cell culture proteins at their state-of-the-art facilities located in Bengaluru. ]]> <![CDATA[Biological E to initiate Ph III trial of COVID-19 vaccine candidate]]> https://biospectrumindia.com/news/95/18503/biological-e-to-initiate-ph-iii-trial-of-covid-19-vaccine-candidate.html https://biospectrumindia.com/news/95/18503/biological-e-to-initiate-ph-iii-trial-of-covid-19-vaccine-candidate.html Sat, 24 Apr 2021 00:00:00 +0530 Biological E. Limited (BE), a Hyderabad-based vaccine and pharmaceutical company, has announced that it has successfully completed the Phase I/II clinical trial of its COVID-19 subunit vaccine candidate in India and received the approval to start the Phase III clinical trial from the Central Drugs Standard Control Organization (CDSCO) - Subject Expert Committee (SEC). BE started the Phase I/II Clinical Trial of its COVID-19 Vaccine Candidate in the second week of November 2020. Its candidate includes an antigen developed by Texas Children’s Hospital Center for Vaccine Development and in-licensed from BCM Ventures, Baylor College of Medicine’s integrated commercialization team, along with Dynavax Technologies Corporation’s (Nasdaq: DVAX) advanced adjuvant CpG 1018TM.   The Coalition for Epidemic Preparedness Innovations (CEPI) and the Biotechnology Industry Research Assistance Council (BIRAC) have provided support for the Phase I/II clinical trials and also for the upcoming Phase III trial of this vaccine candidate. BE's Phase I/II clinical trial evaluated the safety and immunogenicity of the vaccine candidate consisting of the Receptor Binding Domain of the Spike Protein of SARS-CoV-2 at three-dose level adjuvanted with CpG 1018 plus alum, in about 360 healthy subjects in the age range of 18 to 65 years. The vaccination schedule consisted of two doses for each study participant, administered via intramuscular injection 28 days apart. BE’s novel Covid-19 vaccine was found to be safe and well tolerated and immunogenic. The Phase III clinical study to be conducted in 15 sites across India will evaluate the Immunogenicity and Safety of Biological E’s SARS-CoV-2 COVID-19 vaccine for protection against COVID-19 disease in about 1268 healthy subjects in the age range of 18 to 80 years. It is intended to be part of a larger global Phase III study.          ]]> <![CDATA[Allabout Innovations launches ion-based COVID-19 solution]]> https://biospectrumindia.com/news/95/18501/allabout-innovations-launches-ion-based-covid-19-solution.html https://biospectrumindia.com/news/95/18501/allabout-innovations-launches-ion-based-covid-19-solution.html Fri, 23 Apr 2021 18:30:00 +0530 Allabout Innovations has come up with one of its kind ‘ion-based COVID solution’ - ‘Wolf Airmask’ to let you breathe fear free. It is the only device in the world that can produce 100 per cent negative ions efficiently to an area of 1000 sq ft and 10,000 cu ft. However, the range of the device can be enhanced to suit even larger areas. It produces no positive ions or ozone that is harmful to nature. The Wolf Airmask is also the only device tested against the SARS-CoV-2 virus. The device has been tested and approved by Rajiv Gandhi Centre for Biotechnology (RGCB). The organisation has certified the device to be capable of neutralising the COVID viral load in the air and surfaces by 99.9 per cent. Wolf Airmask has been successfully tested against other viruses and MS2 bacteria as well. The Wolf Airmask can discharge up to 100 trillion negative ions per cm3/second which bind with the surface protein/spike protein of coronavirus or any other harmful virus and microbes present in the air and neutralise it. When the device is placed in an area, it ensures that the nearby premises are purified within no time. Sujesh Sugunan – Chairman, Allabout Innovations, commented, “Over the last 10 months, we have been doing extensive research to come out with a solution that can effectively safeguard one's surroundings and provide real-time protection from coronavirus. Wolf Airmask is that product.” The non-regulatory medical device is designed for easiness and comfort as it is plug & play and requires no maintenance for 70,000 hours (approx eight years). The cost is just Rs 29,500 to secure an area of 1000 sq ft and 10,000 cu ft. The device can be easily installed in corporate offices, commercial spaces, residential places, hotels & restaurants and spas & saloons among many others.     ]]> <![CDATA[MG Motor India, Devnandan Gases to increase medical oxygen production ]]> https://biospectrumindia.com/news/95/18486/mg-motor-india-devnandan-gases-to-increase-medical-oxygen-production-.html https://biospectrumindia.com/news/95/18486/mg-motor-india-devnandan-gases-to-increase-medical-oxygen-production-.html Thu, 22 Apr 2021 13:05:00 +0530 MG Motor India has joined hands with Moksi-based Devnandan Gases Pvt. Ltd. to increase the production of medical oxygen. Founded in 2011, Devnandan Gases Pvt Ltd. is one of the key medical oxygen gas producers of Vadodara. MG Motor India is focused on assisting the overall oxygen gas production. It will address specific areas of the manufacturing process such as infrastructure expansion and the elimination of major losses with lean principles. This will help in increasing the production capacity by 25% in the next two weeks with the vision of increasing it further to 50% in the near future. “At MG, we are committed to supporting the fight against the COVID-19 outbreak. As a part of our care for the communities around us, we are boosting the production of oxygen and providing support wherever possible. We had followed a similar approach last year and stabilized the ventilator production at Max Ventilators plant in Vadodara. Now, we are focusing on enhancing oxygen production in the region, which is the need of the hour. We would like to thank the local administration for its constant support and guidance in this initiative,” said Rajeev Chaba, President & MD, MG Motor India. “We express our gratitude to MG for partnering for this noble cause. This collaboration will help us to scale our production as our teams work in unison to boost daily throughput. With MG Motor India’s support in debottlenecking the constraints, the initiative will go a long way in saving more lives in and around the region.” said Vijaybhai Thakkar, Owner of Devnandan Gases Pvt Limited. ]]> <![CDATA[Barco, Sigma-Jones to jointly unveil Op room video integration solution Nexxis]]> https://biospectrumindia.com/news/95/18482/barco-sigma-jones-to-jointly-unveil-op-room-video-integration-solution-nexxis.html https://biospectrumindia.com/news/95/18482/barco-sigma-jones-to-jointly-unveil-op-room-video-integration-solution-nexxis.html Wed, 21 Apr 2021 17:45:00 +0530 Barco announced its partnership with Sigma - Jones  AV LLP to deliver best-in-class digital experiences in healthcare for its next-gen operating room video integration solution Nexxis™. Along with Sigma - Jones, Barco has tied up with five partners across the Asia-Pacific region, including Heytech in Thailand, GET Medical in Taiwan, MedEqual in Philippines, Cetech in Vietnam and Rutledge AV, A diversified company in Australia. With these partnerships, Barco aims to expand its presence in the surgical sector across the APAC region and deliver cutting-edge surgical displays to digital operating rooms thereby increasing awareness for the solutions available to facilitate better and efficient healthcare. Elaborating on the collaboration, Rajiv Bhalla, Managing Director, Barco Electronics Systems Pvt Ltd. said, “Barco’s partnership with Sigma - Jones AV will guarantee that our market-leading technology is deployed in India in the best way possible. It will not only help in delivering cutting edge and future-proof OT integration solutions built on our Nexxis™ platform but also in giving clients the reassurance of great after-sales service and customer care for the long term.” “Raymond V Soans, Director - Sales and Marketing, Sigma - Jones AV stated, “Indian hospitals are experiencing a watershed moment and are leaping forward through the use of new technologies contributing to better patient safety, improved infection control, smarter working environments for staff and safer and more efficient operations.” “Quality is also key here,” said Ingo Aicher, Director, Sigma - Jones AV, “We have been partners with Barco, deploying the Nexxis™ platform in Europe, since early 2013 and it has never let us or any of our clients down.”   ]]> <![CDATA[COVAXIN exhibits 100% efficacy against severe COVID-19 disease]]> https://biospectrumindia.com/news/95/18478/covaxin-exhibits-100-efficacy-against-severe-covid-19-disease.html https://biospectrumindia.com/news/95/18478/covaxin-exhibits-100-efficacy-against-severe-covid-19-disease.html Wed, 21 Apr 2021 15:00:00 +0530 Bharat Biotech has announced phase 3 interim analysis results of COVAXIN®. The second interim analysis is based on accruing more than 87 symptomatic cases of COVID-19. Due to the recent surge in cases, 127 symptomatic cases were recorded, resulting in a point estimate of vaccine efficacy of 78 per cent (95%CI: 61-88) against mild, moderate, and severe COVID-19 disease. The efficacy against severe COVID-19 disease was 100% (95%CI: 60-100), with an impact on reduction in hospitalizations. The efficacy against asymptomatic COVID-19 infection was 70%, suggesting decreased transmission in COVAXIN® recipients. Safety and Efficacy results from the final analysis will be available in June, and the final report will be submitted to a peer-reviewed publication. Based on the achievement of the success criteria, placebo recipients have now become eligible to receive two doses of COVAXIN®.  The Phase 3 study enrolled 25,800 participants between 18-98 years of age, including 10% over the age of 60, with analysis conducted 14 days post 2nd dose. Dr. Krishna Ella, Chairman & Managing Director, Bharat Biotech, said, “Efficacy against SARS-Cov-2 has been established. COVAXIN® has demonstrated an excellent safety record in human clinical trials and in usage under emergency use. COVAXIN® is now a global innovator vaccine derived from Research & Development from India. The efficacy data against severe COVID-19 and asymptomatic infections is highly significant, as this helps reduce hospitalizations and disease transmission, respectively.”  Prof. Balram Bhargava, Secretary Dept. of Health Research & Director General, Indian Council of Medical Research, said, “I am very pleased to state that COVAXIN®, the first indigenous COVID-19 vaccine developed by ICMR and BBIL, has shown the efficacy of 78% in the second interim analysis. The tireless efforts of our scientists at ICMR and BBIL have resulted in a truly effective international vaccine of the highest standards and efficacy. I am also happy to note that COVAXIN® works well against most variants of SARS-CoV-2. These findings together consolidate the position of our indigenous vaccine in the global vaccine landscape.” ]]> <![CDATA[Serum Institute announces Covishield price at Rs 400 for govt hospitals, Rs 600 for private]]> https://biospectrumindia.com/news/95/18476/serum-institute-announces-covishield-price-at-rs-400-for-govt-hospitals-rs-600-for-private.html https://biospectrumindia.com/news/95/18476/serum-institute-announces-covishield-price-at-rs-400-for-govt-hospitals-rs-600-for-private.html Wed, 21 Apr 2021 12:00:00 +0530 For the next two months, Serum Institute of India (SII) will address the limited capacity by scaling up the vaccine production.   Adar Poonawala, CEO, SII said- Going ahead, 50% of our capacities will be served to the Government of India's vaccination program, and the remaining 50% of the capacity will be for the State governments and private hospitals.   Following the Government of India directives, we are hereby announcing the prices of the vaccine:   SII’s COVISHEILD Price per dose State Governments Rs 400 Private Hospitals Rs 600   Considering the global vaccine prices, we are ensuring that our vaccines are affordable in comparison to any other vaccines in the world-   Global Vaccines in the private market  Price per dose American Vaccines        > Rs 1500 Russian Vaccines > Rs 750 Chinese Vaccines > Rs 750   "Furthermore, owing to the complexity, and urgency of the situation it is challenging to supply it independently to each corporate entity. We would urge all corporate and private individuals to access the vaccines through the state facilitated machinery and private health systems. Post 4-5 months, the vaccines will be made available in retail and free trade", he added. ]]> <![CDATA[ekincare, 1mg to hold COVID-19 vaccination drives in 500+ corporate ]]> https://biospectrumindia.com/news/95/18471/ekincare-1mg-to-hold-covid-19-vaccination-drives-in-500-corporate-.html https://biospectrumindia.com/news/95/18471/ekincare-1mg-to-hold-covid-19-vaccination-drives-in-500-corporate-.html Tue, 20 Apr 2021 17:30:00 +0530 ekincare, a health benefits platform that helps companies administer benefits efficiently, optimise healthcare spends and show real health outcomes, has announced a partnership with 1mg to undertake COVID-19 vaccination drive and hence help fight the spread of the second wave. The vaccination drive is carried out with 100 per cent compliance with government directives. 500+ corporates will benefit from the vaccination drive. After being the first healthcare company to take this initiative, ekincare is now at the forefront to conduct workplace vaccinations to battle COVID-19 as well. However, while healthcare companies across the country are doing their part, in times of crisis it is often important to join forces to battle ever-rising odds. In order to help combat the spread of COVID-19’s second wave beyond its current levels, ekincare and 1mg are partnering up to provide on-site vaccinations and medical assistance to all their client corporates going forward. With the combined resources, skilled teams, and proven experience of both companies, their aim is to make sure that India Inc stays healthy, inoculated and fighting fit against the pervasive COVID-19 pandemic. Prashant Tandon, Co-founder, 1mg, said, “1mg and ekincare are uniquely positioned to play a pivotal role in driving large scale vaccination drives. We look forward to working together to provide a seamless vaccination service to corporate employees and lead the fight against COVID-19.” Kiran Kalakuntla, CEO & Founder, ekincare, said, "With an enterprise-grade platform, industry-leading service experience ekincare is happy to partner with 1mg, where ekincare will focus on generating demand and client servicing, while 1mg will help with the supply side of the equation.” ]]> <![CDATA[Bharat Biotech to boost production of COVAXIN® to 700 million doses pa]]> https://biospectrumindia.com/news/95/18470/bharat-biotech-to-boost-production-of-covaxin-to-700-million-doses-pa.html https://biospectrumindia.com/news/95/18470/bharat-biotech-to-boost-production-of-covaxin-to-700-million-doses-pa.html Tue, 20 Apr 2021 17:15:00 +0530 Bharat Biotech announces scale up of manufacturing capacity to produce ~ 700 million doses of COVAXIN® annually.  Manufacturing scale up has been carried out in a stepwise manner across multiple facilities at Hyderabad, and Bengaluru. Inactivated vaccines, while highly safe, are extremely complex and expensive to manufacture, resulting in lower yields when compared to live virus vaccines. Capacity expansion in vaccines manufacturing is a long and tedious process, requiring investments of several millions of rupees and several years. Bharat Biotech is able to expand COVAXIN® manufacturing capacity in a short timeline, mainly due to the availability of new specially designed BSL- 3 facilities, first of its kind for manufacturing in India that have been repurposed and preexisting expertise and know how to manufacture, test and release highly purified inactivated viral vaccines.    Manufacturing partnerships are being explored with our partners in other countries, who have prior expertise with commercial scale manufacture of inactivated viral vaccines under biosafety containment.     To further increase capacities, Bharat Biotech has partnered with Indian Immunologicals (IIL) to manufacture the drug substance for COVAXIN®. The technology transfer process is well underway and IIL has the capabilities and expertise to manufacture inactivated viral vaccines at commercial scale and under biosafety containment. ]]> <![CDATA[Bharat Biotech to produce 700 M doses of COVAXIN annually]]> https://biospectrumindia.com/news/95/18468/bharat-biotech-to-produce-700-m-doses-of-covaxin-annually.html https://biospectrumindia.com/news/95/18468/bharat-biotech-to-produce-700-m-doses-of-covaxin-annually.html Tue, 20 Apr 2021 16:00:00 +0530 Bharat Biotech has announced a scale-up of manufacturing capacity to produce ~ 700 million doses of COVAXIN® annually. Manufacturing scale-up has been carried out in a stepwise manner across multiple facilities at Hyderabad, and Bangalore. Inactivated vaccines, while highly safe, are extremely complex and expensive to manufacture, resulting in lower yields when compared to live virus vaccines. Capacity expansion in vaccines manufacturing is a long and tedious process, requiring investments of several millions of rupees and several years. Bharat Biotech is able to expand COVAXIN® manufacturing capacity in a short timeline, mainly due to the availability of new specially designed BSL- 3 facilities, first of its kind for manufacturing in India that have been repurposed and preexisting expertise and know-how to manufacture, test and release highly purified inactivated viral vaccines.    Manufacturing partnerships are being explored with partners in other countries, who have prior expertise with commercial-scale manufacture of inactivated viral vaccines under biosafety containment.     To further increase capacities, Bharat Biotech has partnered with Indian Immunologicals (IIL) to manufacture the drug substance for COVAXIN®. The technology transfer process is well underway and IIL has the capabilities and expertise to manufacture inactivated viral vaccines at a commercial scale and under biosafety containment. Bharat Biotech uses a proprietary adjuvant Algel-IMDG, that has now proven to be a safe and effective adjuvant, especially to stimulate memory T cell responses. The synthesis and manufacture of the IMDG component have been successfully indigenized and will be manufactured at a commercial scale within the country. This is the first instance where a novel adjuvant has been commercialised in India.   ]]> <![CDATA[Wadhwani Advantage launches growth programme for healthcare biz]]> https://biospectrumindia.com/news/95/18467/wadhwani-advantage-launches-growth-programme-for-healthcare-biz.html https://biospectrumindia.com/news/95/18467/wadhwani-advantage-launches-growth-programme-for-healthcare-biz.html Tue, 20 Apr 2021 15:40:00 +0530 As the COVID pandemic has had a significant negative impact on global health, economy and society, medical companies and experts are now poised to tap the many opportunities and build the future of the healthcare industry. In order to accelerate the process, the unique Wadhwani Advantage programme empowers businesses in the healthcare sector having the capabilities to accelerate their economic growth by 2x-10x with the help of automated 'business discovery and transformation tools’. The Wadhwani Advantage programme includes 1-12 months of engagement and offers up to three years of hand-holding support enabled through a personalised artificial intelligence-led business acceleration process. This programme aims to ignite the growth of businesses in the healthcare sector, accelerate revenues and free cash flows to fund growth for maximising their growth potential through do-it-yourself (DIY) discovery and business solution tool kits and other knowledge resources using AI-enabled automated logic and personalised interventions. Wadhwani Advantage has partnered with the Association of Indian Medical Device Industry (AIMED), Voice of Healthcare (VOH) and Xynteo Vikaasato to leverage synergies in the healthcare space. The goal is to strengthen the business ecosystem without any commercial expectations.  Speaking on the programme, Samir Sathe, Executive Vice President, Wadhwani Advantage, Wadhwani Foundation, said, “Through this programme, we aim to strengthen the Indian healthcare sector by supporting and empowering business enterprises in the sector. We aim to build partnerships with the leading healthcare ecosystem stakeholders to jointly represent the voice of the healthcare businesses and work for their enablement.” Wadhwani Advantage has come up with its own proprietary Wadhwani Index and Scoring system that would set the goals for performance improvement. The proprietary automated discovery tool is designed to empower businesses to measure performance on the basis of 27 key performance indicators.   ]]> <![CDATA[Jubilant Pharma brings novel oral formulation of Remdesivir]]> https://biospectrumindia.com/news/95/18463/jubilant-pharma-brings-novel-oral-formulation-of-remdesivir.html https://biospectrumindia.com/news/95/18463/jubilant-pharma-brings-novel-oral-formulation-of-remdesivir.html Mon, 19 Apr 2021 18:00:00 +0530 Jubilant Pharma Limited, a subsidiary of Jubilant Pharmova Limited, has announced successful completion of safety and pharmacokinetic/absorption studies in animals and healthy human volunteers in India using a novel oral formulation of remdesivir against the commercially available injectable formulation of remdesivir. Jubilant has sought authorization for additional studies for this novel oral formulation from the Drug Controller General of India (DCGI). Jubilant is hoping to provide an affordable, more convenient, easy-to-administer and potentially effective treatment option for COVID-19 patients. The proposed oral treatment is expected to be for 5 days, a duration similar to the injectable dosage form. Remdesivir is the first and the only anti-viral drug fully approved by the US FDA for the treatment of patients with COVID-19 requiring hospitalization. This innovative formulation is likely to ease the capacity constraint that injectable formulation faces and ensure wider and timely availability for the patients of COVID-19. It is specifically designed to avoid hepatic metabolism which results in almost complete first-pass clearance/elimination of remdesivir when it is administered by the traditional oral route. The findings from both preclinical and human studies indicate that the drug is able to undergo absorption when administered using the novel oral formulation. The novel formulation was well tolerated by all the study subjects with no additional safety/ tolerability profile as compared to the injectable product.   ]]> <![CDATA[Prophecy Sensorlytics offers bio-sensor technology to detect COVID-19]]> https://biospectrumindia.com/news/95/18460/prophecy-sensorlytics-offers-bio-sensor-technology-to-detect-covid-19.html https://biospectrumindia.com/news/95/18460/prophecy-sensorlytics-offers-bio-sensor-technology-to-detect-covid-19.html Mon, 19 Apr 2021 15:00:00 +0530 Prophecy Sensorlytics Pvt. Ltd., the Indian subsidiary of MachineSense LLC, USA, has announced the development of a breakthrough in bio-sensor technology that detects Covid-19 and other spike protein viruses in the aerosol phase. This new sensing technology is based on the properties of moving spike proteins and its colloidal interaction with specific liquids which generates reliable electrical signals detecting even a tiny droplet with 50-100 viruses in the aerosol phase. The current technology is not based on specific RNA or DNA sequence but can detect the presence of viruses that are enveloped in spike proteins. Covid-19, Influenza and other cold viruses are enveloped in spike proteins and thus the new sensor will detect the presence of any of these common viruses in the air in any public space or gathering. For the last six months, the R&D team of Prophecy Sensorlytics has tested this bio-sensor technology in various virology labs including the government-owned Rajiv Gandhi Center for Biotechnology (RGCB), Kerala, India. The accuracy of the system has been verified with SARS-CoV-2 Pseudovirions, five strains of Influenza and other different types of viruses with spike proteins. It has also been used in local hospitals and clinics. The company has already filed two utility patents in India & the USA.  ]]> <![CDATA[Indigital Technologies launches social media outreach programme for pharma marketers]]> https://biospectrumindia.com/news/95/18459/indigital-technologies-launches-social-media-outreachprogramme-for-pharma-marketers.html https://biospectrumindia.com/news/95/18459/indigital-technologies-launches-social-media-outreachprogramme-for-pharma-marketers.html Mon, 19 Apr 2021 13:25:00 +0530 Indigital Technologies, a leading research-based technology company that is inspired by pharmaceuticals and driven by healthcare has announced the launch of Indigital Mentor League (IML), a noble social media outreach programme starting from April 19, 2021 which will empower the community of over 10,000 pharma marketers with the help of mentors having industry experience of more than 30 years, through this campaign. Indigital Mentor League is a continuous programme where subject matter experts Dr Ulhas Ganu-CEO, Advisors in Medico-marketing and Management; Rajendra Dhandhukia- Strategy and Leadership Coach; Dr VK Sharma- CEO, Dezin Consulting Private Limited & Visiting Professor, NMIMS; Prabhakar Bethi- CEO, Zesla Solutions; Deepak Verma, General Manager – Zuventus Healthcare Limited & National VP – Society of Pharmaceutical Education & Research (SPER) would be selecting trending topics like new product launch, new trends in patient education, digital transformation for pharma companies, importance of CPD - continuous professional development, telehealth & telemedicine etc and sharing their knowledge with the pharmaceutical product managers. The pharma industry needs upgraded solutions in the market, to offer doctors and patients with proper education, and digitalisation in the pharma industry is a positive move towards the ability to know the customer requirements better. Indigital Technologies believes in bringing together the best practices for patients and doctor engagement with innovative digital solutions coming up with IML, which will help new age marketers to understand the importance of patient education, digitally transforming their brands and new product launches to deliver better treatments to patients. Speaking about the launch of the IML, Hiren Dhuvad, CEO, Indigital Technologies, said, “Indigital Mentor League is a path-breaking initiative from Indigital Technologies, we are sure this continuous professional development programme by pharma experts will empower pharma product managers further.”   ]]> <![CDATA[Fermenta Biotech brings multiple routes to synthesise Molnupiravir for COVID-19 treatment]]> https://biospectrumindia.com/news/95/18448/fermenta-biotech-brings-multiple-routes-to-synthesise-molnupiravir-for-covid-19-treatment.html https://biospectrumindia.com/news/95/18448/fermenta-biotech-brings-multiple-routes-to-synthesise-molnupiravir-for-covid-19-treatment.html Fri, 16 Apr 2021 10:10:00 +0530 Fermenta Biotech Limited (FBL) has announced that it has successfully developed and filed patent application(s) for novel biocatalytic technology of manufacturing Molnupiravir. The patented enzymatic route of synthesis possesses the technological advantage of being efficient and environment-friendly, with higher yields and lower solvent use as compared to existing reported manufacturing processes. Biocatalysis is defined as the use of natural substances that include enzymes from biological sources or whole cells to speed up chemical reactions. Thane based FBL has also optimised these enzymatic steps to achieve a commercially viable technology and believes this process will be substantially cost-effective vis-à-vis chemical synthesis currently followed. Developed by FBL’s R&D team by utilising its proprietary CAL B Lipase immobilised enzyme platform allows for a cost effective biocatalysis which may create a highly affordable therapeutic alternative for the fight against COVID-19.  “With the more we understand of COVID 19 the less we fear it and it is through this understanding that we can potentially create impressive therapeutic developments” says Prashant Nagre, CEO, FBL as he expounds further on the experimental antiviral drug Molnupiravir. Developed at Emory University in Atlanta by Drug Innovation Ventures at Emory (DRIVE). It was then acquired by Ridgeback Biotherapeutics, who later partnered with Merck & Co. to further develop the drug as they are encouraged by preliminary data from a Phase 2a trial of its COVID-19 oral antiviral treatment Molnupiravir. Molnupiravir, originally developed for the treatment of influenza, is ‘orally active’ unlike other potential options of treatment for COVID-19 viz. Remdesivir that are in the injectable format. ]]> <![CDATA[WeHear OX launches bone conduction open ear wireless earphones ]]> https://biospectrumindia.com/news/95/18447/wehear-ox-launches-bone-conduction-open-ear-wireless-earphones-.html https://biospectrumindia.com/news/95/18447/wehear-ox-launches-bone-conduction-open-ear-wireless-earphones-.html Fri, 16 Apr 2021 10:00:00 +0530 Ahmedabad based WeHear OX has launched India’s first bone conduction open ear wireless earphones in the market along with the state of the art 'Hearing care ecosystem' . The COVID-19 pandemic has triggered the basaltic wave of healthcare products in the market. This initiative brought a revolution in the headphones industry as it came as a ray of hope for people suffering from hearing issues. Market shifts have been rapid which persuaded Kanishka Patel, Founder and CEO of WeHear to come up with the much needed solution in the audio-gadget industry. The release of WeHear OX solves a lot of consumer’s problems in the market. The bone conduction technology delivers sound to inner-ear through cheekbones which keeps your ears open to catch ambient sounds. Along with the bone conduction earphones, WeHear also aired the ‘WeHear OX App’ to support the advantages of gadgets for users and incorporate the better user experience. The app features a control centre; personalised experience for users; personal hearing intelligence (PHI) - a patented algorithm which analyzes a user's hearing patterns, data assessment and gives personalised suggestions. Government of India and state government of Gujarat has invested seed funds in WeHear. The brand has been recognised with several acknowledgements lately. ]]> <![CDATA[FICCI recommends financing under PLI-type scheme to support COVID-19 vaccine manufacturers]]> https://biospectrumindia.com/news/95/18435/ficci-recommends-financing-under-pli-type-scheme-to-support-covid-19-vaccine-manufacturers.html https://biospectrumindia.com/news/95/18435/ficci-recommends-financing-under-pli-type-scheme-to-support-covid-19-vaccine-manufacturers.html Wed, 14 Apr 2021 19:05:00 +0530 As we celebrate the approval of Sputnik V vaccine for emergency use, which is indeed a big leap towards accelerating India’s COVID-19 vaccination drive and reaching larger population, we need to be mindful that this is yet not sufficient. Many states in India have been facing the shortage of COVID vaccines over past few days, including locations in Punjab, Rajasthan, Uttarakhand, Uttar Pradesh, Jharkhand and Bihar, compelling state governments to scale down their daily vaccination targets. India intends to vaccinate priority population of 30 crore by August 2021. Given that 10.85 crore people have received at least first dose of COVID vaccination and going with the current rate of 30 lakh vaccinations per day, we would need more than 38 crore doses (of two dose vaccines) to fully vaccinate this priority group. According to reports, Indian government has 2.04 crore doses in pipeline for next few days. Furthermore, since the length of immunity provided by the vaccines is yet not known, we would need to factor in repeat vaccination and maintain the momentum of manufacturing for at least next couple of years. Thus, there is an urgent and critical need to encourage vaccine manufacturers to substantially augment their capacities for production. Since the cost of vaccines have been capped by the government, the vaccine manufacturers need to be provided with appropriate incentives for ramping up the production. FICCI has recommended financing under the PLI-type scheme to support the vaccine manufacturers.  The government also needs to provision for immediate and sufficient grants and subsidies, through the Government of India’s COVID Funds, for those manufacturers that are already developing or manufacturing COVID vaccines in the country. The vaccines that are proven and successful in other markets should be encouraged to be brought into India at the earliest, in order to maintain our supply chains. This should be considered for import and sale of international vaccines as well as initiate manufacturing of such vaccines in the country.   ]]> <![CDATA[Mankind Pharma seeks CDSCO nod to test anti-diabetic molecule]]> https://biospectrumindia.com/news/95/18431/mankind-pharma-seeks-cdsco-nod-to-test-anti-diabetic-molecule.html https://biospectrumindia.com/news/95/18431/mankind-pharma-seeks-cdsco-nod-to-test-anti-diabetic-molecule.html Wed, 14 Apr 2021 13:00:00 +0530 New Delhi-based Mankind Pharma has submitted its first Investigational New Drug (IND) application for approval to the Indian Drug Regulatory Authority, Central Drugs Standard Control Organisation (CDSCO) for MKP10241, a patented first in Class Novel Anti Diabetic Molecule. The company has worked relentlessly in developing this new class of anti-diabetic molecules- designed and developed at the Mankind Research Centre. MKP10241 is a potent and orally administered small molecule, GPR119 agonist. GPR 119 is highly expressed in pancreatic beta cells and intestinal enteroendocrine cells. With subsequent approval by CDSCO and the launch of this first in class drug, the company strongly anticipates that it will be of immense benefit to diabetic patients, and will prove to be extremely effective in lowering blood sugar levels. What makes MKP10241 unique is its mechanism of action. GPR119 elevates intracellular secondary messengers such as cAMP inside the cells and promotes postprandial insulin and incretin secretion (GLP-1) in a glucose-dependent manner. This dual mechanism by GPR119 in mediating glucose-dependent insulin secretion is distinct from the currently available therapeutic options for Type 2 diabetes and thus becomes a promising new approach for the treatment of type 2 diabetes and related metabolic disorders. RC Juneja, Executive Chairman, Mankind Pharma said, "Our team of scientists have worked tirelessly & with immense passion to develop this novel drug to benefit the people, and it will be affordable for patients. Mankind Pharma is committed to expanding its portfolio of products in the Indian market in all major therapeutic areas for the benefit of patients, prescribers and the healthcare system.” ]]> <![CDATA[Biocon opens COVID-19 vaccination centre at Syngene campus in Bengaluru]]> https://biospectrumindia.com/news/95/18422/biocon-opens-covid-19-vaccination-centre-at-syngene-campus-in-bengaluru.html https://biospectrumindia.com/news/95/18422/biocon-opens-covid-19-vaccination-centre-at-syngene-campus-in-bengaluru.html Tue, 13 Apr 2021 08:00:00 +0530 The Biocon Group of Companies has inaugurated a Vaccination Centre at the Bengaluru campus of Syngene International Limited as part of the nationwide drive for mass vaccination of individuals above 45 years of age to protect them against COVID-19. The group has started vaccinating all eligible employees in keeping with its commitment to ensure the health and safety of its workforce. As a responsible corporate citizen, it will also work closely and in partnership with the Government of Karnataka to create awareness and offer this service to all people who are eligible in the Electronic City area of Bengaluru. The Biocon Group is the 1st Corporate entity to kickstart this vaccination centre in Bengaluru. Kiran Mazumdar Shaw, Executive Chairperson, Biocon, said, “We feel proud and privileged that the Government of Karnataka has given us the first permission as a corporate to initiate vaccination drive for our employees. We will be working closely and in partnership with the government to roll out this vaccination drive, create awareness and offer this service to all people who are eligible in the Electronic City area of Bengaluru, apart from our own employees.” Dr Mahesh Bhalgat, Chief Operating Officer, Syngene International Limited, said, "The Biocon Group is committed to ensuring the safety and wellbeing of its workforce. Since July 2020, we are proactively testing our employees to identify infection cases and immediately quarantine them and provide necessary medical support. We are now happy to provide free vaccination for our employees and their family. This is an extension of our commitment to safeguarding our employees' health as well as a reflection of our commitment to support the government's efforts to combat and contain the pandemic." As a part of its commitment to address the novel coronavirus pandemic in India, the Biocon Group is also offering a comprehensive portfolio of products for treating mild to severely ill COVID-19 patients. They have introduced ARAFLU® (Favipiravir) in addition to Cytosorb® and ALZUMAB-L™, and Syngene is manufacturing Remdesivir under a voluntary licensing agreement with Gilead. ]]> <![CDATA[APACMed India onboards new Executive Committee ]]> https://biospectrumindia.com/news/95/18399/apacmed-india-onboards-new-executive-committee-.html https://biospectrumindia.com/news/95/18399/apacmed-india-onboards-new-executive-committee-.html Fri, 09 Apr 2021 12:15:00 +0530 The Asia Pacific Medical Technology Association (APACMed) welcomes its new Executive Committee (ExCo) in India, in a timely move amid the pandemic when players in the medical technology (MedTech) industry need to work even closer together to grow a more robust, resilient and adaptive healthcare ecosystem. The ExCo is committed to continuously engage with regulatory bodies, policymakers, healthcare professionals, industry members and other stakeholders to facilitate patient access to innovative and life-saving medical technologies; thereby improving patient care outcomes. The India ExCo appointments are: Pavan Mocherla, MD, Becton Dickinson India, South Asia, as the Chairperson. Mocherla also serves as the Chairman for Advanced Medical Technology Association (Advamed) in India. Meenakshi Nevatia, MD, Stryker India as Vice-Chairperson. Nevatia is on the Board of the Medical Technology Association of India (MTAI) and is the Chair of the Med Tech Committee at AMCHAM (American Chamber of Commerce). Narendra Varde, MD, Roche India & Neighbouring Markets as Vice-Chairperson. Varde is an active spokesperson for a number of industry associations and professional organisations such as FICCI and others. He is also on the governing council of NATHEALTH. The ExCo will build on the association’s mission to promote innovation and impact policy that advances healthcare access for patients in India.   Commenting on the new appointments of the India ExCo, Harjit Gill, CEO, APACMed, said, “We are in a period of transformational change within the healthcare ecosystem, and are delighted to have MedTech industry leaders step forward to contribute and steer India’s healthcare infrastructure and delivery of care through innovative collaborations and engagements with key stakeholders in the system.” ]]> <![CDATA[OPPI, WFEB host 'COVID-19 Vaccine and Beyond' panel discussion ]]> https://biospectrumindia.com/news/95/18395/oppi-wfeb-host-covid-19-vaccine-and-beyond-panel-discussion-.html https://biospectrumindia.com/news/95/18395/oppi-wfeb-host-covid-19-vaccine-and-beyond-panel-discussion-.html Thu, 08 Apr 2021 18:10:00 +0530 Organisation of Pharmaceutical Producers of India is association with World Forum for Ethics in Business (WFEB) hosted a panel discussion as a part of the global virtual summit on World Health Day. The theme of the OPPI curated panel discussion was COVID-19 Vaccine and Beyond. The overarching theme of the summit was, ‘Changing Paradigms in a Pandemic World’. The OPPI panel discussion constituted of speakers like Dr Shekhar Mande, Director General, Council of Scientific and Industrial Research, Ministry of Science and Technology, Government of India, Sudarshan Jain, Secretary general, IPA, Dr Ratna Devi, Chair of The Board of Trustees, IAPO Founding Member IPAG & CEO Dakshayani and Amaravati Health and Education, Dr Shashank Joshi, Member, Maharashtra COVID Task Force and Consultant Endocrinologist, Lilavati Hospital, Andrew Blasi, Director Crowell & Moring International and Visiting Faculty, International Anti-Corruption Academy, Rajaram Narayanan, MD, Sanofi India and Vikrant Shrotriya, MD, Novo Nordisk India. OPPI’s panel discussion put into perspective the pivotal contribution of pharmaceutical companies in bringing relief on individual’s health and contribution towards the society, during this virtual conference.  Commenting on the event KG Ananthakrishnan, DG, OPPI said, “OPPI’s panel was centred on the ongoing vaccination drives across the globe to fight the pandemic and beyond. We are of the belief that innovation and collaborations likes these will pave the way for future and strengthen us to fight any unprecedented crisis in the future.”  Through dedicated keynote panel discussions and interactive workshops, the virtual summit brought together leading stakeholders from politics, business, academics and civil societies to challenge the status quo and seek answers for citizen’s to better navigate through the pandemic and the time to come. The conference also examined tools and best practices to support citizens’ mental health. ]]> <![CDATA[HARMAN India to cover employees', dependents' COVID-19 vaccination cost ]]> https://biospectrumindia.com/news/95/18392/harman-india-to-cover-employees-dependents-covid-19-vaccination-cost-.html https://biospectrumindia.com/news/95/18392/harman-india-to-cover-employees-dependents-covid-19-vaccination-cost-.html Thu, 08 Apr 2021 15:45:00 +0530 HARMAN International, a wholly-owned subsidiary of Samsung Electronics Co, Ltd focused on connected technologies for automotive, consumer and enterprise markets, announced that it will cover the total cost of vaccination against COVID-19 for its eligible employees and their dependents in India. Vikrant Gupta, Vice President – Human Resources, HARMAN said, “Even in these uncertain times, our employees have shouldered multiple responsibilities by managing their personal and professional commitments while working remotely from home and helping deliver mission critical projects for our customers. With the vaccination drive in full swing, we want to ensure our employees and their families are safe and healthy.” Amid rising cases and renewed concerns over the spread of coronavirus, as many as 8,400 employees in the country and their dependents who are enrolled in the company's medical benefits programme will benefit from this policy. This is in continuation with the necessary protocols taken by HARMAN since the beginning of the pandemic to safeguard its employees.  ]]> <![CDATA[HealthEdge, Thoughtworks partner to onboard engineering leaders in India ]]> https://biospectrumindia.com/news/95/18390/healthedge-thoughtworks-partner-to-onboard-engineering-leaders-in-india-.html https://biospectrumindia.com/news/95/18390/healthedge-thoughtworks-partner-to-onboard-engineering-leaders-in-india-.html Thu, 08 Apr 2021 13:00:00 +0530 HealthEdge®, a health insurance industry’s first digital nervous system that provides automation and seamless connectivity between all parts of a payer’s administrative and clinical systems announced a partnership with ThoughtWorks to build a Center of Excellence across its development operations. ThoughtWorks will work closely with HealthEdge to create a world class team, doubling its size by more than 100 hires by the end of 2021. The goal is to scale HealthEdge’s processes around sourcing, capacity building, and training to effectively onboard engineering leaders in India. HealthEdge is located in Koramangala, Bengaluru, the heart of the IT capital of India and Hinjewadi in Pune. The planned Center of Excellence will house multiple functions including development, product management, technical operations, and DevOps. The team will lead the way to achieve organisational goals with crucial programs like transformation, performance and scalability, and data lake development.  “We are building a great company that will be the epicenter of healthcare transactions,” said Steve Krupa, CEO of HealthEdge. “When people join HealthEdge, they are joining a progressive, flexible, first-class team who pride themselves on the core principles of customer value, first-principles thinking, cross-functional collaboration, continuous improvement, and engineering excellence. Our India-based operation is at a point of extreme acceleration and with the help ThoughtWorks, we aim to be the premier employer for India’s best talent.” ]]> <![CDATA[Practo teleconsultation service now in 15 Indian languages]]> https://biospectrumindia.com/news/95/18388/practo-teleconsultation-service-now-in-15-indian-languages.html https://biospectrumindia.com/news/95/18388/practo-teleconsultation-service-now-in-15-indian-languages.html Wed, 07 Apr 2021 17:40:00 +0530 Practo, India’s leading integrated healthcare company, has introduced its teleconsultation service in multiple Indian languages. This initiative will allow online consultation users to choose a doctor who can speak in their preferred language. Currently, this service covers 15 languages – including Hindi, Marathi, Tamil, Kannada and Bengali – with more to be added soon. With this, Practo is one step closer to breaking down access barriers for 200 million unique users in the future. After receiving lakhs of user requests for language-specific features on Practo, this was launched as a pilot project earlier this year, with Hindi as the alternate option for users to choose from.  During this time, 25 per cent of all online consultations on Practo were conducted in vernacular languages, with  Hindi, Tamil, Marathi, and Kannada (in that order) emerging as their preferred language(s) for consultation. Around 67 per cent of all vernacular consultations were from users living in non-metro cities. Remarkably, 65 per cent of all vernacular consults were from users aged 60 and above. Commenting on the new initiative, Siddhartha Nihalani, VP - Product Growth, Practo, said, “In enabling interactions in native languages for online consultations - that undoubtedly enjoys wide acceptance - we hope to be one step closer to turning our vision of building access to quality healthcare into reality.” The vernacular language support feature will now be available on both Practo app and website. The company is also planning to introduce new interface capabilities to make the doctor-patient interaction more seamless and engaging.  ]]> <![CDATA[DB Life Sciences launches Curol+ to combat air, dust pollution in India]]> https://biospectrumindia.com/news/95/18378/db-life-scienceslaunches-curol-to-combat-air-dust-pollution-in-india.html https://biospectrumindia.com/news/95/18378/db-life-scienceslaunches-curol-to-combat-air-dust-pollution-in-india.html Tue, 06 Apr 2021 16:50:00 +0530 DB Life Sciences LLP, a wholly-owned subsidiary of The House of Fusion Group, has introduced its revolutionary liquid-based anti pollution product Curol+ in India.  Curol+ is a liquid-based anti pollution product that aims to 'CURE ALL' dust and air pollution related problems.  A game changer in removing the air-borne particles inside the room which carry viruses and infections along the dust mites, it’s has launched 3 different variants: Curol+ Outdoors Curol+ Indoor Hard flooring Curol+ Indoor Carpet Curol+ transforms the floor into a giant air filter and diminishes dust levels. It works on enhancing the indoor air quality and also refreshing the breathing environment at home, office, industrial and commercial spaces.  The outdoor product reduces PM levels outdoors. The effectiveness is minimum 65 per cent in just seven days of usage. Speaking on the launch, Dhruv Bhatnagar , CEO , DB Life Sciences LLP, said, “Curol+ delivers powerful chemical-free liquid-based anti-pollution product guarantees minimum reduction of fine particulate air pollution PM 2.5 & PM 10 in one week and is affordable.” “We are committed to unilaterally support India’s war on air pollution and the National Clean Air Programme (NCAP).  India is a strategic market for us and we have established a manufacturing plant in Gurugram, Haryana, which reaffirms our commitment India’s Vision - ‘Make in India, make for the World,” added  Bhatnagar. Curol+ DB Life Sciences is developing a real time app provides IoS & Android app which will give users accurate and continuous access to the indoor air quality and other allied parameters at all times as part of a specific package along with the monitor. ]]> <![CDATA[Honeywell launches 'Make in India' monitoring solution for pharma shipments]]> https://biospectrumindia.com/news/95/18371/honeywell-launches-make-in-india-monitoring-solution-for-pharma-shipments.html https://biospectrumindia.com/news/95/18371/honeywell-launches-make-in-india-monitoring-solution-for-pharma-shipments.html Tue, 06 Apr 2021 09:00:00 +0530 American multinational firm Honeywell has introduced a data-monitoring solution that leverages machine learning and blockchain technology to capture critical shipping-condition data of temperature-sensitive goods ranging from pharmaceuticals and perishables to electronics – and can even help address counterfeiting problems that can arise while goods are in transit. A “Make in India” offering, Honeywell BluTag 360™ incorporates temperature and humidity sensors to monitor shipment conditions. BluTag 360 will be manufactured locally and is one of the first products to be launched under the recently-announced Impact by Honeywell brand. This is the only product that has been entirely designed in India, at the company's technology centre in Bengaluru. The company is seeking WHO certification for the product. BluTag 360 is the first of an upcoming portfolio of offerings with global certifications to address various regulatory requirements enabling safe vaccine distribution. “The COVID-19 vaccine distribution process underscores the criticality of knowing specific environmental details about these sensitive products during the logistics process. BluTag 360 enables users to digitally capture, record and retrieve critical data on a single dashboard and generate reports across cold chain shipments,” said Chaitanya Paspuleti, General Manager, Impact by Honeywell. The company is already in touch with the key pharma manufacturers in India to market this product further. "Our trials have been extremely successful, with respect to COVID-19 vaccine shipments and the other regular ones. Also, our product is already airline approved.", added Chaitanya Paspuleti. “BluTag 360 comes with USB interface connectivity and provides digitized shipment records in a tamper proof manner. The product is able to function in an offline mode when network connectivity is poor and is capable of accurately recording readings across a wide temperature range while being highly battery efficient. The solution can integrate into Enterprise Resource Planning and transportation systems to help with regulatory compliance, and it features proprietary software that supports global data integrity and security standards. The entire solution was conceptualized and developed end to end in Honeywell Technology Solutions in India and this certainly is a proud moment for my team that worked on converting this vision into reality” mentioned Ajeya Motaganahalli, Chief Technology Officer, Safety and Productivity Solutions, Honeywell Technology Solutions (HTS) India. ]]> <![CDATA[Panacea Biotec to produce 100 M doses of Sputnik V vaccine in India per year]]> https://biospectrumindia.com/news/95/18370/panacea-biotec-to-produce-100-m-doses-of-sputnik-v-vaccine-in-india-per-year.html https://biospectrumindia.com/news/95/18370/panacea-biotec-to-produce-100-m-doses-of-sputnik-v-vaccine-in-india-per-year.html Tue, 06 Apr 2021 08:00:00 +0530 The Russian Direct Investment Fund (RDIF, Russia’s sovereign wealth fund), and New Delhi based Panacea Biotec have announced cooperation to produce 100 million doses per year of Sputnik V, the world’s first registered vaccine against coronavirus. Production of Sputnik V at Panacea Biotec sites will help facilitate global supply of Sputnik V to international partners of RDIF. To date Sputnik V has been registered in 59 countries globally with total population of over 1.5 billion people. Efficacy of Sputnik V is 91.6% as confirmed by the data published in the Lancet, one of the world's oldest and most respected medical journals. Dr. Rajesh Jain, Managing Director of Panacea Biotec, said: “We are pleased to collaborate with RDIF to produce Sputnik V for global markets. Panacea Biotec brings decades of vaccine manufacturing and distribution know-how to scale-up Sputnik V supplies. Panacea Biotec will produce Sputnik V in its internationally accredited facilities complying to strict GMP standards and prequalified by WHO.” ]]> <![CDATA[SIRO Clinpharm aims to bridge gaps in pharma service provider market]]> https://biospectrumindia.com/news/95/18367/siro-clinpharm-aims-to-bridge-gaps-in-pharma-service-provider-market.html https://biospectrumindia.com/news/95/18367/siro-clinpharm-aims-to-bridge-gaps-in-pharma-service-provider-market.html Mon, 05 Apr 2021 13:00:00 +0530 SIRO Clinpharm has announced that they have become a partner of ACROSS Global Alliance (ACROSS) and will help represent India in working towards the common goals and objectives of ACROSS in bridging a gap in the pharmaceutical service provider market. ACROSS is a global alliance of clinical research organizations (CRO’s) also known as Partners along with special service providers known as Qualified Vendors. The Partners form the core of the ACROSS organization. Mumbai based SIRO Clinpharm will have the opportunity to provide its core services and expertise in India’s geography. Commenting on this partnership, Karan Daftary, Director, SIRO Clinpharm said, “The relationship provides mutually beneficial outcomes for both parties, with SIRO Clinpharm having the opportunity to assist ACROSS’s clients in India, whilst ACROSS and its Partners can assist Siro Clinpharm’s clients with their overseas (i.e., outside India) clinical expertise in over 96 countries worldwide. This partnership opportunity enables Siro Clinpharm to actively participate in Global Clinical trials, where India is one of the regions that would be covered, in collaboration with other ACROSS Partners.”  The ACROSS Partnership model mimics the success of the multiple airline industry alliances, with ACROSS being a focused, central coordinating body that oversees the conduct of seamless global clinical trials with minimal overheads, thus passing on cost-effective solutions to the benefit of its clients. ]]> <![CDATA[Zydus seeks DCGI approval for using PegIFN in COVID-19 treatment]]> https://biospectrumindia.com/news/95/18368/zydus-seeks-dcgi-approval-for-using-pegifn-in-covid-19-treatment.html https://biospectrumindia.com/news/95/18368/zydus-seeks-dcgi-approval-for-using-pegifn-in-covid-19-treatment.html Mon, 05 Apr 2021 00:00:00 +0530 Zydus Cadila has announced that its Phase III clinical trials with Pegylated Interferon Alpha 2b, PegiHep (PegIFN) has shown promising results in treating COVID-19. In what could be a breakthrough in the disease management of COVID-19, the interim results indicate that PegIFN (Interferon) when administered early on, could help patients recover faster and avoiding much of the complications seen in the advanced stages of the disease. PegIFN in COVID-19 has several add-on advantages compared to other anti-viral agents. The treatment regimen would be less cumbersome and more affordable for patients as Pegylated Interferon Alpha 2b, is a single dose regimen. It would also ensure better compliance. PegIFN has very well-established safety with multiple doses in chronic hepatitis B and C patients since many years. Patients on Pegylated Interferon Alpha 2b during the trial also showed lesser need for supplemental oxygen, clearly indicating that it was able to control respiratory distress and failure which has been one of the major challenges in treating COVID-19. The findings are in line with recently reported importance of early IFN treatment given in combination with steroids in the treatment of COVID-19 (Lu et al, Signal Transduction and Targeted Therapy (2021) 6:107, a Nature publication. With these positive results, the Company has applied for an approval for additional indication with the DCGI for the use of PegIFN in the treatment of COVID 19. Speaking on the development, Dr. Sharvil Patel, Managing Director, Cadila Healthcare Ltd., said, “We are encouraged by the results of Phase III study of Pegylated Interferon alpha 2b which has confirmed the potential to reduce virus titres when given earlier in the disease. With Indian Innovation at the forefront helping the country fight the pandemic with diagnostics, vaccines and therapeutics, this marks an important milestone. At Zydus, we stand committed to our endeavour of supporting patients and caregivers with access to treatment options that are affordable and can help in better disease management of COVID 19 at different stages.” Besides conducting a Phase 2 trial in Mexico, the Company is also working with the USFDA for Pegylated Interferon alpha-2b in order to initiate appropriate clinical trials in US. ]]> <![CDATA[Havas Health & You strengthens global partnerships with new appointments]]> https://biospectrumindia.com/news/95/18357/havas-health-you-strengthens-global-partnerships-with-new-appointments.html https://biospectrumindia.com/news/95/18357/havas-health-you-strengthens-global-partnerships-with-new-appointments.html Thu, 01 Apr 2021 16:45:00 +0530 Mumbai based Havas Health & You, the health and wellness division of Havas Group India, with the intention to propel this growth and strengthen meaningful global partnerships, has announced the elevation of Susan Josi as Managing Director of Havas Health & You- SEA & Middle-East, and Sangeeta Barde as Managing Director of Havas Life Sorento, with immediate effect. Susan and Sangeeta have been at the helm of Havas Health & You's APAC-based agency since the network's acquisition of Sorento. Susan is best known throughout the network for her proven success in driving the Havas Village model in India and for her development of the agency's global client roster in the SEA and Middle-East regions, where Havas Health & You presence continues to grow and strengthen on a daily basis. Commenting on her new role, Josi says, "The landscapes are changing dynamically and there is an intensified importance being placed on health and wellness. Our capabilities in these areas have grown to a point where it makes sense to have consistent regional leadership as health brands prioritise their presence in these markets." Sangeeta is most known for her achievements including the coordination of a platform that deeply integrates creative, media, digital, and data systems in domestic and global markets. Barde will drive the success model for offshoring and achieving strategic and impactful globalisation initiatives. On stepping into her new role, Barde says, "I am looking forward to leaning into the vast digitisation opportunities in our data and media centres and working to perfect new and simplified content creation models. Deep collaboration with groups and partners domestically and internationally is a necessary and exciting endeavour.”   ]]> <![CDATA[Unimech Healthcare unveils cloud-based disinfection technology solutions]]> https://biospectrumindia.com/news/95/18358/unimech-healthcare-unveils-cloud-based-disinfection-technology-solutions.html https://biospectrumindia.com/news/95/18358/unimech-healthcare-unveils-cloud-based-disinfection-technology-solutions.html Thu, 01 Apr 2021 00:00:00 +0530 Unimech Healthcare,a division of Unimech Aerospace and Manufacturing, has announced the launch of UniClean, its array of solutions to prevent ‘Work Place Sickness’ and ‘Crowd Spread Infections’. UniClean with its cloud based UVGI technology provides 99.99% virus free sterilization of air and surfaces in offices, industries, hospitals, malls, theatres, hotels, restaurants, etc. UniClean’sarray of offerings includes: Clean-Air acloud-based air sanitizing system for Heating Ventilation and Air Conditioning(HVAC) systems Closet-Sterile a sensor based continuous disinfectant system for closed spaces Uni-Sterile Robot a disinfectant system mounted on remote guided vehicles (RGV) and autonomous guided vehicles (AGV) for surface sanitization powered by UVGI technology. This array of solutions offers an effective ‘Continuous Disinfection System’ for companies and commercial business units. UniClean’ssolutions combine UVGI technology with sensor/tech enabled functionality and cloud- based monitoring which completely avoids any manual intervention in the disinfection process and keeps the system on auto mode for effective functioning. Further the efficacy of the UniCleanarray of solutions has been tested and proved through advanced microbes testing and UV testing equipment’, which clearly shows the effectiveness of microbas elimination pre and post installation. Dr. Nidhi Bhatt, Lead-Microbiology Wing, Unimech Healthcare, said “UVC at 254nm is very effective against all natural microbiota, virus, foodborne pathogens, molds and yeast. The UVGI application damages the DNA and RNA of pathogens thus destroying their ability to function and replicate. This ensures microbe and virus free clean breathable air and surface”. Bengaluru based Unimech Healthcare is also working on the launch of its new range of solutions to address ‘Hospital Acquired Infections (HAI)’. ]]> <![CDATA[DigiHealth seeks to develop world-class pharmaceutical supply chain]]> https://biospectrumindia.com/news/95/18360/digihealth-seeks-to-develop-world-class-pharmaceutical-supply-chain.html https://biospectrumindia.com/news/95/18360/digihealth-seeks-to-develop-world-class-pharmaceutical-supply-chain.html Thu, 01 Apr 2021 00:00:00 +0530 DigiHealth Technologies LLP (DigiHealth), a wholly-owned entity of Mumbai based ABCD Technologies LLP (to be renamed as IndoHealth Services LLP) has announced acquisition of AIOCD Pharmasofttech AWACS Private Limited (AWACS) and Pharmarack Technologies Private Limited (Pharmarack). Both AWACS and Pharmarack have over the years created a digital ecosystem in the pharmaceutical industry downstream supply chain. The investment has been made with a view to develop a world-class pharmaceutical supply chain & distribution IT ecosystem and support the government’s National Digital Health Mission (NDHM). ABCD Technologies LLP was incorporated on 10th February 2021 as a limited liability partnership (LLP) and has been reconstituted subsequently with the involvement of leading pharmaceutical companies (Alkem, Cadila Healthcare, Cipla, Dr Reddy’s, Lupin, Mankind, Sun Pharma, Torrent) in India. The partnership is aimed at digitizing the pharmaceutical supply chain for improving the availability & accessibility of medicines for patients. AWACS is engaged in the business of pharmaceutical data collection and market research focused on data analytics. Pharmarack is an integrated B2B Healthcare platform that combines technology, analytics, logistics, and supply chain financing. Both AWACS and Pharmarack have an independent management team with strong governance protocols to ensure data privacy and neutrality. ]]> <![CDATA[Biocon takes generic formulations to Brazil in partnership with Libbs Farmaceutica]]> https://biospectrumindia.com/news/95/18342/biocon-takes-generic-formulations-to-brazil-in-partnership-with-libbs-farmaceutica.html https://biospectrumindia.com/news/95/18342/biocon-takes-generic-formulations-to-brazil-in-partnership-with-libbs-farmaceutica.html Tue, 30 Mar 2021 00:00:00 +0530 Biocon Ltd has announced a partnership between Biocon Pharma Limited, a wholly owned subsidiary of Biocon Limited, and Libbs Farmaceutica, a leading pharmaceuticals company in Brazil, to launch generic drugs in Brazil, the world’s sixth most populous country. This partnership, which marks the entry of Biocon’s generic formulations into Latin America, builds upon a successful association with Libbs, which began in 2017 to launch biosimilar Trastuzumab in Brazil. It reflects Biocon’s commitment to make affordable healthcare accessible for patients the world over, by establishing a strong global presence for its formulations portfolio, either directly or through strategic partnerships. As part of the out-licensing deal with Libbs, Biocon Pharma will be responsible for drug development and manufacturing, while Libbs will leverage its deep expertise and reach in Brazil to import, distribute and market, subject to approvals from the Brazilian health regulatory agency, ANVISA. Siddharth Mittal, Chief Executive Officer and Managing Director, Biocon Ltd, said, “Expanding our association with Libbs Farmaceutica, a trusted partner, to our generic formulations, will help us establish a firm footing in Latin America, starting with Brazil. We remain committed to expanding our global presence with high-quality and affordable medicines and invest in strengthening capabilities that enable us to serve patients globally.” ]]> <![CDATA[Boehringer Ingelheim India focuses on partnerships in NCD management]]> https://biospectrumindia.com/news/95/18325/boehringer-ingelheim-india-focuses-on-partnerships-in-ncd-management.html https://biospectrumindia.com/news/95/18325/boehringer-ingelheim-india-focuses-on-partnerships-in-ncd-management.html Thu, 25 Mar 2021 00:00:00 +0530 Boehringer Ingelheim India has shared its roadmap of partnerships and patient access programmes to sustain its growth momentum in 2021.  Vani Manja, Managing Director, Boehringer Ingelheim India said, “Boehringer Ingelheim India aspires to be amongst the top five multinational pharmaceutical companies in India over the next few years. We have been enabling access to our innovator products to patients across India and the neighbouring markets in the diabetes, cardiovascular, stroke and respiratory diseases segments. Our plan in these therapy areas is to build sustainable partnerships to ensure an ecosystem of access and care for patients. We have initiated action in that direction.” In diabetes, Boehringer Ingelheim’s research and development has been focused on bringing comprehensive solutions to the management of Type 2 diabetes and its related cardio-renal-metabolic complications. The Company has been investing significantly in understanding the condition in its entirety. In the area of stroke, Boehringer Ingelheim India has established a partnership model to help hospitals across 23 States and 3 UTs to improve the standard of care for stroke management. The partnership model entails – 1. development of an increased network of stroke-ready centres across India; 2. supporting healthcare professionals with world-class training to identify and treat stroke within the recommended treatment window; and 3. enabling an ecosystem for stroke care by bringing in multi-disciplinary teams that can address disease management through the continuum of care. Boehringer Ingelheim India collaborates with 380 centers enabling support for over 10,000 patients to access effective stroke care. In addition to Human Pharma, Boehringer Ingelheim India’s Animal Health business, which focuses on advanced, preventive health solutions for Pets and Poultry, aims to more than double the sales over the coming five years. ]]> <![CDATA[Indigital Technologies launches personalised video prescription platform]]> https://biospectrumindia.com/news/95/18323/indigital-technologies-launches-personalised-video-prescription-platform.html https://biospectrumindia.com/news/95/18323/indigital-technologies-launches-personalised-video-prescription-platform.html Wed, 24 Mar 2021 19:00:00 +0530 Indigital Technologies, a leading research-based technology company that is inspired by pharmaceuticals and driven by healthcare, has announced the launch of Kyoiku, a personalised video prescription platform that will assist healthcare practitioners in making the complex instructions for the patients simpler and understandable. Kyoiku features artificial intelligence (AI) technology that converts the prescriptions and doctor’s instructions into easy to understand, high quality videos. Use of this prescription video software improves adherence and clears all the doubts on how to take it. With Kyoiku, one gets video instructions for 130,000 medications with new additions every day. We are all aware that patients and their caregivers are expected to follow a variety of very complex instructions and doctor visits are becoming shorter with the growing virus fear and intervention of telemedicine. Often there is insufficient time to explain all instructions in detail and verify understanding of the patients. It is a known fact that medical misunderstanding could turn out to be a high cost for the patients and their caregivers, Indigital Technologies introduced this product Kyoiku to make the process easier for them to understand and follow in a text as well as video format. Speaking about the launch of the product, Hiren Dhuvad, CEO, Indigital Technologies, said, “Kyoiku is an initiative in accomplishing our mission to empower the doctors, medical practitioners and the patients for better outcomes and better treatment through technology driven initiatives. I believe intervention of technology for various healthcare needs is the future.”   ]]> <![CDATA[HealthCube collaborates with Samsung to strengthen Anaemia Mukt Bharat initiative]]> https://biospectrumindia.com/news/95/18322/healthcube-collaborates-with-samsung-to-strengthen-anaemia-mukt-bharat-initiative.html https://biospectrumindia.com/news/95/18322/healthcube-collaborates-with-samsung-to-strengthen-anaemia-mukt-bharat-initiative.html Wed, 24 Mar 2021 18:50:00 +0530 HealthCube, a point-of-care technology-enabled diagnostics service provider, has partnered with Samsung to enable blood tests for school students under the government’s Anaemia Mukt Bharat initiative. Samsung is the mobility technology partner for HealthCube with its palm-sized solution – Galaxy Tab A. HealthCube works towards making diagnosis simple and hassle-free in rural areas. They needed technology that could aid them in collecting a large amount of data from the field which could be stored with acute security. With the Galaxy Tab A, HealthCube is able to collect a large amount of data from the field which can be retrieved locally. The multi-functional tab has made the process of data collection and recording instant and its big screen helps the on-field record data from the screening easily. Unique patient records can be created instantly, using the tablet’s high-res camera. Speaking about this, Dr Ramanan Laxminarayan, Founder, HealthCube, said, “HealthCube is used to screen school children for their haemoglobin levels. We store data on HealthCube’s EzDx app installed on Galaxy Tab A.” Adding further, Akash Saxenaa, Senior Director, Enterprise Sales, Samsung India, said, “Samsung collaborated with HealthCube to provide time-saving and cost-effective real-time diagnosis to rural patients. Enabled by Galaxy Tab A, healthcare workers with access to HealthCube’s EzDx app could manage patient data in a quick, easy and secure manner. Samsung is proud to have been the technological partner for HealthCube’s noble initiative.” Aided by Samsung’s technology, HealthCube is able to store and upload the unique records of the patient on the cloud which can then be immediately shared with/by the healthcare workers. The GPS feature on the Tab helps in tracking the location of operators and beneficiaries in real time ensuring their safety.     ]]> <![CDATA[Practo launches veterinary telemedicine service]]> https://biospectrumindia.com/news/95/18315/practo-launches-veterinary-telemedicine-service.html https://biospectrumindia.com/news/95/18315/practo-launches-veterinary-telemedicine-service.html Wed, 24 Mar 2021 14:40:00 +0530 Practo has launched veterinary telemedicine service on its platform. Teaming with licensed veterinarians across the country, the company will be offering 24*7 online consultation services for pets. Launched as a pilot project last month, Practo recorded nearly two lakh search queries from pet parents. Buoyed by the positive response, the speciality was launched officially as a part of the company’s telemedicine services. Most of the veterinary queries revolved around diet management for pets, medication for fleas and ticks, food allergies among pets, and behavioural problems among pets. Queries came in from more than 40 cities with Bengaluru, Hyderabad, Delhi NCR, and Mumbai topping the list. Commenting on the new initiative, Siddhartha Nihalani, VP - Product, Practo, said, “Our foray into virtual veterinary care aligns with our larger vision of improving access to quality healthcare. With many people taking care of pets for the first time during the Coronavirus-induced lockdown, and several others anxious about visiting a clinic amid this pandemic, we want to enable them with a convenient yet reliable solution.” Dr Daisy Rani, a veterinarian from Chennai with 25 years of experience, said, “I am glad that a company like Practo is going the extra mile for the well-being of pets by adding veterinary services as a part of its telemedicine platform.” With Practo’s veterinary telemedicine service, pet parents can connect with a verified veterinarian via audio or video call or even text messages - anytime, anywhere - in just 60 seconds. Not only is this convenient, but also crucial to get timely advice on common but potentially harmful ailments. The service will be available both on Practo’s app as well as the website. ]]> <![CDATA[Omega Healthcare acquires himagine Solutions to expand services portfolio]]> https://biospectrumindia.com/news/95/18306/omega-healthcare-acquires-himagine-solutions-to-expand-services-portfolio.html https://biospectrumindia.com/news/95/18306/omega-healthcare-acquires-himagine-solutions-to-expand-services-portfolio.html Wed, 24 Mar 2021 00:00:00 +0530 Omega Healthcare, a leading provider of outsourced revenue cycle management and other healthcare support services, has announced the acquisition of himagine Solutions, a St Louis, MO-based provider of medical coding and registry services. The transaction expands the service capabilities and geographical footprint of both companies, enhancing the ability to service clients globally. Through this acquisition, Omega Healthcare will be able to expand both its global delivery model and its clinical services portfolio. himagine’s US delivery capabilities strengthen Omega’s ability to support clients with a more integrated end to end solution. Omega also gains himagine’s expertise in clinical documentation improvement (CDI), coding audits, and chart abstraction for medical registries including the US cancer and trauma registries. himagine benefits from major additions to its capabilities including Omega’s end-to-end revenue cycle management and patient interaction services, as well as access to Omega’s extensive analytics and automation offerings. This acquisition is part of Omega’s growth strategy, supported by the company’s investors, Goldman Sachs Merchant Banking and Everstone Group. “This acquisition is a natural extension of our ongoing efforts to provide clients with end-to-end RCM solutions and enhanced clinical capabilities which are now driven by value-based payment models,” said Gopi Natarajan, CEO, Omega Healthcare. “Joining forces with himagine equips us with key new clinical abilities, a truly global delivery model with larger stateside resources, and a bigger pool of talent for serving client needs,” said Anurag Mehta, President, Omega Healthcare. Michael DiMarco, CEO, himagine Solutions said, “With almost 18,000 employees worldwide, a broad suite of RCM services, and the ability to leverage Omega’s proprietary technology solutions, we are in an ideal position to help clients simplify their health information management needs.” Both companies will continue to operate under their existing brands. The transaction closed on March 10, 2021. Financial details were not disclosed. ]]> <![CDATA[Piramal Pharma Solutions signs service agreement with US firm Plus Therapeutics]]> https://biospectrumindia.com/news/95/18310/piramal-pharma-solutions-signs-service-agreement-with-us-firm-plus-therapeutics.html https://biospectrumindia.com/news/95/18310/piramal-pharma-solutions-signs-service-agreement-with-us-firm-plus-therapeutics.html Wed, 24 Mar 2021 00:00:00 +0530 Piramal Pharma Limited's (PPL) Contract Development and Manufacturing Organization (CDMO), Piramal Pharma Solutions (PPS), based in Mumbai, has announced that the Company has entered into a Master Services Agreement (MSA) with Plus Therapeutics, Inc. for Piramal to perform services related to the development, manufacture, and supply of Plus Therapeutics' RNL-Liposome Intermediate Drug Product. This MSA includes the transfer of analytical methods, development of microbiological methods, process transfer and optimization, intermediate drug product manufacturing, and stability studies. The transfer will be performed at the PPS drug product facility located in Lexington, Kentucky in the US. The two Companies envision that the MSA will lead to clinical and commercial supply agreements for the drug product at the appropriate stage of development. PPS' Lexington site is recognized as a North American leader in the formulation, development and manufacturing of sterile parenteral drug products. The Lexington site has the capability to support drug development for New Chemical Entities (NCEs), generics, and molecules that might be following the 505(b)(2) regulatory pathway. Peter DeYoung, CEO, Pharma Solutions, Piramal Pharma Limited, stated that, "We are excited to partner with Plus Therapeutics. We believe that this represents the start of a long, collaborative and mutually beneficial relationship that will address our ultimate objective of reducing the burden of disease on patients." ]]> <![CDATA[Zydus brings down price of Remdesivir brand to Rs 899]]> https://biospectrumindia.com/news/95/18319/zydus-brings-down-price-of-remdesivir-brand-to-rs-899.html https://biospectrumindia.com/news/95/18319/zydus-brings-down-price-of-remdesivir-brand-to-rs-899.html Wed, 24 Mar 2021 00:00:00 +0530 In a significant move Ahmedabad based Zydus has made its brand of Remdesivir, Remdac more affordable at Rs. 899 for a 100 mg lyophilized injection. Remdac which was launched in August 2020 at Rs. 2800, continues to be India’s most economical brand of Remdesivir and a critical drug in the treatment of COVID-19. This move to further revise the prices will go a long way in helping patients during these critical times. Speaking on the development Dr. Sharvil Patel, Managing Director, Cadila Healthcare Limited said, “Through the course of this pandemic, our efforts have been focused on making therapies accessible and affordable to people. RemdacTM has been one of the critical drugs in the disease management on COVID and we hope that this price cut will enable people from every strata of the society to access this critical drug.” ]]> <![CDATA[Olympus's AI diagnostic support system comes up in AIG, Hyd]]> https://biospectrumindia.com/news/95/18304/olympuss-ai-diagnostic-support-system-comes-up-in-aig-hyd.html https://biospectrumindia.com/news/95/18304/olympuss-ai-diagnostic-support-system-comes-up-in-aig-hyd.html Tue, 23 Mar 2021 13:15:00 +0530 Olympus Corporation recently conducted a virtual seminar on Endoscopic AI Diagnosis Education in India. With the aim to make people’s lives healthier, safer and more fulfilling as a global MedTech firm, the company has established an AI diagnostic support system at the Asian Institute of Gastroenterology (AIG) based in Hyderabad and also initiated a research and training project for the doctors and specialists at the major medical institution. Olympus aims to assist in the development of physicians and promote the use of endoscopic diagnostics. There is a severe shortage of doctors who can conduct precision diagnostics with endoscopes, which are essential for early detection and treatment of cancer. Through the project, prominent doctors have trained AIG doctors to be equipped with the techniques needed to detect diseases and differential diagnosis via colonoscope, as well as prepared them to pass on the knowledge and instruct the next generation of endoscopists in India. Olympus Corporation has been conducting the endoscopic education since October 2020 with support from the Japanese Ministry of Internal Affairs and Communications to train doctors in India and neighbouring countries and to contribute to the popularisation and development of endoscope diagnostics using the latest AI technology. Present at the seminar, Dr Goutham Reddy Katukuri, Consultant – Gastroenterology of AIG Hospitals said, “Visual diagnosis of colorectal polyps may improve the cost-effectiveness of colonoscopy and reduce complications of polypectomy. A more precise diagnosis can be expected in the coloscopic inspection using AI diagnostic support system, and the difference in the diagnosis among observers may be corrected.” Speaking about this co-operation, Satoshi Hemmi, Ministry of Internal Affairs and Communications, Japan,  commented, “The aim is to contribute to the introduction and dissemination of Japan’s endoscopic AI diagnostic support system to India and neighbouring countries in response to the social issue of increasing cancer prevalence in India.” ]]> <![CDATA[Cipla, SIGA Technologies collaborate to deliver access to novel AMR drugs ]]> https://biospectrumindia.com/news/95/18303/cipla-siga-technologies-collaborate-to-deliver-access-to-novel-amr-drugs-.html https://biospectrumindia.com/news/95/18303/cipla-siga-technologies-collaborate-to-deliver-access-to-novel-amr-drugs-.html Tue, 23 Mar 2021 12:40:00 +0530 Cipla Therapeutics and SIGA Technologies, Inc, a commercial-stage pharmaceutical company focused on the health security market have announced entering into a strategic partnership to deliver sustained innovation and access to novel antibacterial drugs, particularly against biothreats. “The strategic collaboration between Cipla and SIGA will provide the Biomedical Advanced Research and Development Authority (BARDA), a US Department of Health and Human Services (HHS) department, with solutions for its biothreat and public health needs,” said Garrett Ingram, CEO, Cipla Therapeutics. “We are thrilled to have teamed up with Cipla to tackle the very important public health challenge of Antimicrobial resistance (AMR),” said Phil Gomez, CEO, SIGA. “Our longtime partner BARDA has recognised this as a critical issue, for not only public health, but biothreats as well. With our drug development expertise under the animal rule and government contracting expertise, and Cipla’s novel antibiotic products and extensive manufacturing capabilities, we are confident that together we are ideally-suited to provide innovative solutions to BARDA and other government customers.” This partnership provides an opportunity for the US government agencies such as BARDA to advance preparation and health security programme initiatives with the novel antibiotic ZEMDRI® (Plazomicin injection) owned and marketed by Cipla in the US, while working through a known partner in SIGA, an entity with deep expertise in USG contracting and BARDA’s hands-on approach to advanced development. ]]> <![CDATA[Nevon Solutions designs combination of mask & face shield to counter COVID-19]]> https://biospectrumindia.com/news/95/18302/nevon-solutions-designs-combination-of-mask-face-shield-to-counter-covid-19.html https://biospectrumindia.com/news/95/18302/nevon-solutions-designs-combination-of-mask-face-shield-to-counter-covid-19.html Tue, 23 Mar 2021 08:40:00 +0530 A Mumbai based tech firm Nevon Solutions has announced the introduction of a newly-researched battery powered full-face mask that promises an effective solution to stop COVID spread. The mask not only promises a COVID solution but also a solution to any future pandemics yet to come along with protection from air pollution. The new Nevon Air Mask is a game changing innovation in COVID times, considering its ability to protect ones mouth, nose and eyes, all 3 entry points for a COVID infection. The existing masks in use, only cover ones nose and mouth leaving your eyes open to environment even with face shield on. Additionally, the burden of sucking in air through existing mask filters makes it highly uncomfortable to wear a mask for longer durations, again leading the user to unmask for breath and exposure to infections. According to Neeraj P Sawant, CEO of Nevon Solutions, “The reason we are not yet able to stop or even slow down the spread of COVID is due to improper masking. A next-generation full-face mask is urgently needed, despite the emergence of vaccines. To stop the spread of COVID we simply need to filter air reaching our mouth, nose as well as eyes at all times. Another reason is to make the mask comfortable for breathing as well as wearing for longer periods of time, these are the simple facts that Nevon engineers used to design the mask.” This new mask will offer 5 layer filtration protection for the nose, mouth and eyes and also comfortable for the wearer for five to ten hours of use. Along with infections, it filters PM2.5 dust particles as well as gases and pollutants. The filters are not expensive and are made with the certified filter materials with added active carbon filtration. ]]> <![CDATA[Glenmark to commercialise RYALTRIS nasal spray in Canada ]]> https://biospectrumindia.com/news/95/18299/glenmark-to-commercialise-ryaltris-nasal-spray-in-canada-.html https://biospectrumindia.com/news/95/18299/glenmark-to-commercialise-ryaltris-nasal-spray-in-canada-.html Tue, 23 Mar 2021 00:00:00 +0530 Glenmark Pharmaceuticals has announced that its subsidiary Glenmark Specialty SA in Switzerland and an affiliate of Bausch Health Companies Inc have entered into an exclusive licensing agreement for the commercialisation of Glenmark’s innovative nasal spray RYALTRIS under review by Health Canada. Under the terms of the agreement, Glenmark will be responsible for regulatory approvals and supply of RYALTRIS ™ for the Canadian market. Bausch Health, Canada will be responsible for the commercialisation of RYALTRIS ™ in the Canadian market, following regulatory approval. Glenmark will receive an upfront payment, launch and sales‐based milestone payments in addition to royalties and supply price from sales of RYALTRIS.  RYALTRIS (Olopatadine Hydrochloride 665 mcg and Mometasone Furoate 25 mcg), is currently under review by Health Canada with a proposed indication for the treatment of seasonal allergic rhinitis in adults and children over 12 years of age.  Commenting on the agreement, Sanjeev Krishan, President & Business Head ‐ North America, Glenmark Pharmaceuticals, said, “We are pleased to partner with Bausch Health Canada, and recognise their strong foothold in the prescription and OTC market in Canada. This agreement will help us reach a larger patient population and extend the multiple benefits of RYALTRIS to a significant market. Glenmark continues to build a strong portfolio in respiratory medicine, and RYALTRIS marks our first true global brand launch till date.”    “We are pleased to add Ryaltris to our allergy product portfolio and eager to make it available to Canadian patients suffering from allergies,” said Richard Lajoie, President, Bausch Health, Canada.  In Canada, allergic rhinitis is estimated to afflict 25 per cent of the population, and can have a significant impact on sleep, work and school performance.   ]]> <![CDATA[Virchow Biotech to produce 200 M Sputnik V doses annually]]> https://biospectrumindia.com/news/95/18295/virchow-biotech-to-produce-200-m-sputnikv-doses-annually.html https://biospectrumindia.com/news/95/18295/virchow-biotech-to-produce-200-m-sputnikv-doses-annually.html Mon, 22 Mar 2021 15:10:00 +0530 The Russian Direct Investment Fund (RDIF) and Hyderabad based Virchow Biotech Private Limited (part of the Virchow Group), one of the leading vaccine and pharmaceutical producers in India, announce the agreement to produce in the country up to 200 million doses per year of Sputnik V, the world’s first registered vaccine against coronavirus. The technology transfer is expected to be completed in the Q2 of 2021 followed by full-scale commercial production of Sputnik V. Virchow Biotech capacities will help facilitate global supply of Sputnik V to international partners of RDIF. Kirill Dmitriev, CEO, Russian Direct Investment Fund, commented, “Vaccine partnerships are the only way to overcome the pandemic. The world continues its fight against coronavirus and we see a growing interest in Sputnik V vaccine as it is one of the most efficient vaccines available. The agreement with Virchow Biotech is an important step to facilitate the full-scale local production of the vaccine in India and to supply our international partners globally.” Dr Tummuru Murali, Managing Director, Virchow Biotech, said, “We are glad to sign a cooperation agreement with RDIF to produce the Sputnik V coronavirus vaccine. Virchow’s proven capabilities in large scale drug substance manufacturing should help meet the global demand for this vaccine. We are also happy to learn of the positive feedback that this vaccine has been receiving from all countries.”   ]]> <![CDATA[US firm OsteoStrong announces major expansion to India]]> https://biospectrumindia.com/news/95/18290/us-firm-osteostrong-announces-major-expansion-to-india.html https://biospectrumindia.com/news/95/18290/us-firm-osteostrong-announces-major-expansion-to-india.html Mon, 22 Mar 2021 00:00:00 +0530 US based OsteoStrong International Inc., the wellness franchise founded by CEO, entrepreneur and author Kyle Zagrodzky, has announced a major expansion to India and its surrounding countries. Despite a tumultuous year for many businesses, OsteoStrong continues to experience robust growth with over 145 wellness centers in the United States, Australia, Greece, New Zealand, Norway, Bulgaria, Cyprus, Iceland, Sweden, Poland, Denmark, and now India.  OsteoStrong's first center in India is located on Loudon Street in Kolkata, India. The Grand Opening is scheduled for late spring 2021. This is the first in a large expansion of OsteoStrong throughout India and its surrounding countries. Right now OsteoStrong has 145 centers open worldwide. This is another massive success for the company and its mission to help people around the world improve their bone health with patented osteogenic loading technology. The partnership's mission is to help 100 million people throughout India and surrounding countries dealing with bone health and related issues. The agreement between Rishi Todi and Chetan Todi of the NPR Group headquartered in Kolkata, along with Perry Eckert, (OsteoStrong's Master Franchisee in Australia) plans to open OsteoStrong locations throughout India, Bangladesh, Nepal and Sri Lanka. ]]> <![CDATA[Stelis Biopharma to produce, supply 200 M doses of Sputnik V]]> https://biospectrumindia.com/news/95/18285/stelis-biopharma-to-produce-supply-200-m-doses-of-sputnik-v.html https://biospectrumindia.com/news/95/18285/stelis-biopharma-to-produce-supply-200-m-doses-of-sputnik-v.html Fri, 19 Mar 2021 17:55:00 +0530 The Russian Direct Investment Fund (RDIF) and Stelis Biopharma Pvt Ltd, the biopharmaceutical division of Strides, a global pharmaceutical company headquartered in India, have partnered to produce and supply a minimum of 200 million doses of the Russian Sputnik V vaccine against coronavirus sufficient to vaccinate 100 million people. The agreement between RDIF and Stelis Biopharma was reached under the aegis of Enso Healthcare LLP (part of Enso Group), RDIF's coordination partner for sourcing Sputnik V vaccines in India. The parties intend to commence supplies from the Q3 of 2021. Stelis will also continue to work with the RDIF to provide additional supply volumes beyond the initial agreement. Kirill Dmitriev, CEO, Russian Direct Investment Fund, said, “We are delighted to announce our agreement with Stelis Biopharma for a significant capacity of Sputnik V. The significant vaccine volumes, which will be produced jointly with Stelis, will help to widen access to the vaccine on a global scale.” Arun Kumar, Founder of Strides Group, said, “We are delighted to partner with RDIF to make a substantial contribution towards providing global supply of the Sputnik V vaccine which is one of the most efficacious approved vaccines commercially available. We will also work with RDIF to increase the availability of the vaccine beyond our initial commitments.” ]]> <![CDATA[Premas Biotech, Oramed announce oral COVID-19 vaccine candidate ]]> https://biospectrumindia.com/news/95/18288/premas-biotech-oramed-announce-oral-covid-19-vaccine-candidate-.html https://biospectrumindia.com/news/95/18288/premas-biotech-oramed-announce-oral-covid-19-vaccine-candidate-.html Fri, 19 Mar 2021 00:00:00 +0530 Gurugram based Premas Biotech has announced the development of an oral COVID-19 vaccine that has shown efficacy after a single dose, in conjunction with Jerusalem based Oramed Pharmaceuticals Inc.Accelerating the vaccine’s path to market, Premas, Oramed and other shareholders, have formed Oravax Medical Inc. which has received exclusive licenses from Oramed and Premas to develop oral COVID-19 vaccines.After a single dose of the Oravax COVID-19 capsule, efficacy was evident through antibody production in a pilot animal study. Oravax’s vaccine promoted both systemic immunity through Immunoglobulin G (IgG), the most common antibody in blood and bodily fluids that protects against viral infections, and Immunoglobulin A (IgA) which protects the respiratory and gastrointestinal tracts against infection.Premas’ protein-based VLP (Virus Like Particle) vaccine candidate creates triple protection against the SARS CoV-2 virus Spike, Membrane, and Envelope targets. The vaccine candidate is also safe, efficacious and well-tolerated at normal to high doses, and generated high titres of neutralizing antibodies. The VLP is manufactured using Premas’ proprietary D-Crypt™ platform, which is highly scalable and can be manufactured on large scales.Premas Biotech Co-Founder and Managing Director Dr. Prabuddha Kundu commented, “An oral COVID-19 vaccine that harnesses and combines the true potential of the two platforms, Premas’ D-Crypt™ technology platform with Oramed’s world-leading oral protein delivery platform POD® is an excellent example of a true collaboration and can rapidly advance into late-stage clinical trials. Oramed’s experience and success in conducting Phase 2 and 3 oral protein trials positions our program very favorably in the race to find an effective oral COVID-19 vaccine that can be administered by anyone anywhere We are looking forward to sharing clinical data soon.” ]]> <![CDATA[Vasu Healthcare launches wide range of herbal skincare products ]]> https://biospectrumindia.com/news/95/18277/vasu-healthcare-launches-wide-range-of-herbal-skincare-products-.html https://biospectrumindia.com/news/95/18277/vasu-healthcare-launches-wide-range-of-herbal-skincare-products-.html Thu, 18 Mar 2021 17:55:00 +0530 Gujarat-based Vasu Healthcare Pvt Ltd - a leading brand in herbal and Ayurveda space with its flagship brand TRICHUP, has forayed into herbal skincare. The company has launched a wide range of herbal skincare products in personal care that includes face washes, shower gels, body lotions, skin cream, face masks, and face scrubs etc under ‘Vasu Naturals’. In the next three years, Vasu Healthcare is aiming for sales of Rs 250 crore, Vasu Naturals is expected to contribute 20-25 per cent of company’ sales. Speaking on the launch, Hardik Ukani, Managing Director, Vasu Healthcare Pvt Ltd, said, “Vasu Naturals is the result of company's strong Ayurveda heritage and R&D capabilities. The range is aimed at offering innovative yet pocket friendly range and as per lifestyle of millennial. Products of Vasu Naturals are created with natural herbs including neem, aloevera, lemon, turmeric etc. In addition to domestic markets, we are launching ‘Vasu Naturals’ in our existing network of 50 plus countries and digital platforms. Our R&D team is further working on expanding the personal hygiene and skincare range including oral healthcare.” “Awareness for personal hygiene has increased a lot globally post Covid and acceptance of natural and Ayurvedic solutions has picked up a great deal. We are receiving excellent response from domestic market as well as international markets in particular from MENA region, CIS and Europe region. In addition to the traditional channels, Vasu Naturals range will be available on all the leading e-commerce portals including Amazon, Flipkart, BigBasket, Nykaa and its own store https: //www.vasustore.com/. The company is also exploring tie-up with a leading modern trade partner for Vasu Naturals,” said Sagar Patel, Director, Vasu Healthcare Pvt Ltd.      ]]> <![CDATA[Colgate unveils ayurvedic toothpaste for diabetics ]]> https://biospectrumindia.com/news/95/18276/colgate-unveils-ayurvedic-toothpaste-for-diabetics-.html https://biospectrumindia.com/news/95/18276/colgate-unveils-ayurvedic-toothpaste-for-diabetics-.html Thu, 18 Mar 2021 14:15:00 +0530 Colgate-Palmolive (India) Limited has researched and developed a special toothpaste for people with diabetes, Colgate for Diabetics, through a collaboration with dentists and diabetes experts. This launch aims to bring attention to the bidirectional link between diabetes management and oral health management and provide an effective solution for oral health problems faced by diabetics in an effort to help overall diabetes management. Colgate for Diabetics toothpaste is a clinically proven formula with a unique blend of Ayurvedic ingredients such as madhunashini, neem, jamun seed extract, and amla. This special formula kills anaerobic bacteria in the mouth which is the root cause for many oral health problems for diabetics. This unique Ayurvedic blend is FDA-approved and is available for sale at pharmacies both online and offline. Arvind Chintamani, Vice President, Marketing, Colgate-Palmolive (India) Limited, said, “People with diabetes have special oral health needs and there is a 2-way connection between oral care and diabetes care. We are very excited and are looking forward to bringing this terrific innovation to people with Diabetes across India.” Ashish Jain, ex-President, Indian Society of Periodontology & lead author of ‘Good Clinical Practice Guidelines for the Management of Periodontal Disease in Patients with Diabetes’, states, "As the evidence is increasingly pointing to inflammation as a common linkage mechanism in oral health and diabetes, ways and means to address the resolution of inflammation is the need of the hour.” Manoj Chawla, Diabetologist from Mumbai & Member, RSSDI, states, "Expert consensus and evidence‑based guidelines have paved the path for the need for optimal clinical management of periodontal conditions in diabetes patients or patients at risk for diabetes. Therefore, a patient with diabetes needs to pay extra attention to his oral health and dental care, besides controlling his blood glucose levels.” ]]> <![CDATA[Vardhman Health Specialities enters into adult immunisation space]]> https://biospectrumindia.com/news/95/18270/vardhman-health-specialities-enters-into-adult-immunisation-space.html https://biospectrumindia.com/news/95/18270/vardhman-health-specialities-enters-into-adult-immunisation-space.html Wed, 17 Mar 2021 01:05:00 +0530 Vardhman Health Specialities (VHS Group), based in Bengaluru & Mumbai, has announced its foray into ‘Adult Immunisation’ and its plans to grow this as a distinct category and market in India. At an exclusive virtual press meet held on 17 March, VHS announced the launch of Immugard, a first of its kind platform and end-to-end vaccine management solution, right from manufacturing to warehouse to mid-level to last mile & end consumer. VHS LogiTech will also implement a unique delivery model reaching out to university & educational campuses, corporate organisations and at-home administration for direct, end consumers.  Vardhman’s group company VHS LogiTech through which business will be conducted for the adult immunisation business, has already invested over Rs 15 crore in the new division and platform and plans to invest another Rs 100 crore over the next year, primarily in technology, warehouse infrastructure and R&D. The group as a whole clocked revenues of Rs 500 crore in FY 20-21 and plans to double it to over Rs 1000 Cr. In the next two to three years and the adult immunisation division will contribute a significant 30% of this.   VHS Group also announced the appointment of a distinguished Advisory Board headed by esteemed, Dr. Giridhar J Gyani, Director of AHPL, as Chairperson, along with Dr. Sanjeev Singh, Dr Thuppil Venkatesh, PhD, FACBI, FIABMS LEAD MAN OF INDIA, Dr Subhrojyoti Bhowmick, Dr. Debashish Gupta and Brigadier Dr Paramjit Singh Dhot.  VHS Logitech has joint hands with Association of Healthcare Providers (AHPL) and with vaccine providers to increase awareness and access to vaccines for Influenza, diphtheria, Pertussis, Tentanuc, Typhoid, Hepatitis A & B, Measles, Mumps, Rubella, among others, manufactured by reputed pharma majors such as Pfizer, Abott, GSK, Sanofi and other key players. As a first step, VHS is in talks for efficient distribution and increase of easy access of the COVID-19 vaccine.   ]]> <![CDATA[Shape Up! India launches oral collagen for healthy ageing ]]> https://biospectrumindia.com/news/95/18262/shape-up-india-launches-oral-collagen-for-healthy-ageing-.html https://biospectrumindia.com/news/95/18262/shape-up-india-launches-oral-collagen-for-healthy-ageing-.html Tue, 16 Mar 2021 11:35:00 +0530 Maintaining active joints and younger-looking skin is essential for healthy ageing. Chronic degenerative conditions are becoming more prevalent due to micronutrients, malnutrition, environmental toxicity and an increasing number of uninsured & unsecured ageing population living under stress. In a major breakthrough, doctors of regenerative medicine, dermatologists, general physicians, orthopaedic consultants and physiotherapists from across India, along with Margie Aliprandie, Health & Wellness Consultant from the US had a brainstorming symposium on this which culminated in the launch of revolutionary oral collagen – Liquid BioCell Life in Bengaluru. Shape Up! India, a non-profit organisation and a leading health services provider, has launched this innovative, natural and patented product. “Liquid BioCell Life is a delicious liquid nutraceutical that promotes healthy ageing, active joints, and younger-looking skin. It provides a unique and proprietary combination of science-substantiated ingredients and antioxidant-rich phytonutrients that synergistically support a healthier life,” explains Aliprandie. The product claims to be helpful for millions of chronic degenerative cases and sportspersons. “Liquid BioCell Life contains a number of health-promoting, functional ingredients. They include patented Liquid BioCell, resveratrol, and 13 super-fruits known to contain antioxidants, vitamins, minerals and dietary fibres. Scientific studies on individual ingredients suggest that it can synergistically promote the overall health of ageing people,” adds Dr Srinivasamurthy D, Consultant- Regenerative Medicine, Medical Director, Bangalore Institute of Regenerative Medicine (GIOSTAR USA). ]]> <![CDATA[Alkem Labs launches affordable anti-epileptic drug in India]]> https://biospectrumindia.com/news/95/18257/alkem-labs-launches-affordable-anti-epileptic-drug-in-india.html https://biospectrumindia.com/news/95/18257/alkem-labs-launches-affordable-anti-epileptic-drug-in-india.html Mon, 15 Mar 2021 18:05:00 +0530 Mumbai based Alkem Laboratories has announced the launch of Brivasure, an affordable anti-epileptic drug for the treatment of epilepsy in India. Brivasure, Alkem’s anti-epileptic drug (AED) is a generic version of the parent molecule. Alkem has launched the drug in the market at price, Brivasure 25mg Rs 79.50/strip, Brivasure 50mg 148.50/strip, Brivasure 75mg 230/strip, Brivasure 100mg 295/strip, post patent expiry of innovator product, of Brivaracetam as on February 21, 2021. The drug has been approved by the Drugs Controller General of India (DCGI) in the adjunctive management of partial onset seizure with or without secondary generalisation. The drug has exhibited faster onset of action, efficacy with favourable safety profile. Yogesh Kaushal, President, Chronic Business, Alkem Laboratories Ltd,  said, With the launch of Brivasure, we aim to make the treatment of epilepsy easily accessible to the patients at affordable pricing.” Dr Akhilesh Sharma, President and CMO, Alkem Laboratories Ltd, added, “With the introduction of brivaracetam by Alkem, we are optimistic about making steady progress and revolutionising epilepsy treatment in India as well as globally. Levetiracetam has been considered a broad spectrum antiepileptic drug in India but after the clinical usage for over a decade we have learnt that it has got its own disadvantages and is associated with certain behavioural side effects. Brivaracetam seems to be filling up this gap with its promising efficacy which was observed even in those patients who had previously discontinued Levetiracetam due to side effects, benign side effects and simpler dosing regimen making it more convenient and cost effective proposition for the patients. ]]> <![CDATA[Dr Cyrus Poonawalla receives BioSpectrum Lifetime Achievement Award 2020]]> https://biospectrumindia.com/news/95/18254/dr-cyrus-poonawalla-receives-biospectrum-lifetime-achievement-award-2020.html https://biospectrumindia.com/news/95/18254/dr-cyrus-poonawalla-receives-biospectrum-lifetime-achievement-award-2020.html Mon, 15 Mar 2021 13:25:00 +0530 Biospectrum India hosted Biospectrum Excellence Awards 2020 on March 12, 2021. The event was organised on a virtual platform. The awards felicitated the stalwarts of Indian Biotechnology & Health Science Industry. The highlight of Biospectrum Excellence Awards 2020 were the jury awards in the following categories: BioSpectrum Lifetime Achievement Award; BioSpectrum Person of the Year Award; BioSpectrum Leadership Award; BioSpectrum Entrepreneur of the Year; Woman Entrepreneur of the Year Award; BioSpectrum BioPharma Product of the Year; and BioSpectrum Diagnostics Product of the Year. India's top biotech companies were honoured. The winners were top companies of the industry selected in BioSpectrum industry survey held in the year 2019. The awards were delayed due to the ongoing COVID-19 pandemic.  The event commenced with a panel discussion on 'Will sharing COVID-19 vaccine efforts reap more rewards?’. The panelists for the discussion were Dr SD Ravetkar, Executive Director, Serum Institute of India, Pune, Dr Sriram Natarajan, Founder, MolBio DIagnostics, Goa, Dr Vishal G Warke, Director R&D, Cell Culture and Immunology, Himedia Laboratories, Mumbai and Dr Raches Ella, Head Business Development and Advocacy, Bharat Biotech. The panelists discussed about how it can turn out to be more rewarding for the industry to share their innovative vaccine technology with others and work together. The panel discussion was followed by the awards presentation ceremony where the key highlight was the jury awards. The jury panel for BioSpectrum Excellence Awards 2020 consisted of: Chairperson-  Dr Renu Swarup, Secretary, Department of Biotechnology (DBT), Government of India, New Delhi; Members- Dr Gagandeep Kang- Professor, Department of Gastrointestinal Sciences, Christian Medical College, Vellore; Deepanwita Chattopadhyay, Chief Executive Officer, IKP Knowledge Park, Hyderabad; Utkarsh Palnitkar, Founder and Managing Director, Aarna Corporate Advisors, US; Bhagirath Choudhary, Founder Director, South Asia Biotechnology Centre (SABC), New Delhi.  The winners of the awards for BioSpectrum Excellence Awards 2020 are:  BioSpectrum Jury Awards Lifetime Achievement Award: Dr Cyrus Poonawalla, Chairperson, Serum Institute of India, Pune Product of the Year Award I: ROTAVAC 5D, Bharat Biotech- Dr Krishna Ella, Chairman & Managing Director, Bharat Biotech, Hyderabad •Product of the Year Award II: TrueNat, MolBio Diagnostics- Sriram Natarajan, Chief Executive Officer, Molbio Diagnostics, Goa •Woman Entrepreneur of the Year Award: Dr Geetha Manjunath, CEO, Niramai •Entrepreneur of the Year Award: Kavita Iyer Rodrigues, Chief Executive Officer, Zumutor Biologics, Bengaluru   Industry Ranking Awards  Biopharma section Top MNC biopharma company - Novo Nordisk India Pvt Ltd, Bengaluru Top Indian biopharma company – Serum Institute of India, Pune Diagnostics section Top Indian MedTech company (Indian) – Transasia Bio Medicals Ltd, Mumbai   Bio services section TOP CDMO company -Piramal Pharma Solutions, Mumbai  TOP CRMO company - Syngene International Ltd, Bengaluru  TOP CRAMS company - Suven Life Sciences Ltd, Hyderabad  Top CLRO Company - Veeda Clinical Research Limited, Ahmedabad  TOP CRISP company - Anthem Biosciences Private Limited, Bengaluru  Biosupplier section  Top biosupplier (MNC) - Waters India Pvt Ltd, Bengaluru Top biosupplier (Distributor) - DSS Imagetech Pvt Ltd, New Delhi Top analytical instruments company (MNC) - Thermo Fisher Scientific India Pvt Ltd, Mumbai  Top analytical instruments company (Distributor) - DSS Imagetech Pvt Ltd, New Delhi  Industrial enzymes section Top industrial enzyme company (Indian) - Rossari Biotech Ltd, Mumbai  Top MNC industrial enzyme company (MNC) - Novozymes South Asia Private Limited, Bengaluru Bio Incubator section Top Bioincubator in public sector – Bangalore Bioinnovation Centre, Bengaluru, Karnataka Top Bioincubator in private sector – KIIT Technology Business Incubator, Bhubneswar, Odisha   Editor’s Choice Awards Bio Supplier Industry Leader Award - Dr GM Warke, Founder & CMD, Hi Media Innovation in CRO sector in India – TCG Lifesciences Pvt Ltd Digital Media Disruptors in Biotech & Life Science - Thermo Fisher Scientific Top Innovator for Biologics Packaging & Delivery  - West Pharmaceutical Packaging India ]]> <![CDATA[AstraZeneca India's NSCLC drug Tagrisso receives marketing approval]]> https://biospectrumindia.com/news/95/18244/astrazeneca-indias-nsclc-drug-tagrisso-receives-marketing-approval.html https://biospectrumindia.com/news/95/18244/astrazeneca-indias-nsclc-drug-tagrisso-receives-marketing-approval.html Wed, 10 Mar 2021 19:40:00 +0530 AstraZeneca Pharma India Limited has announced that it has received marketing approval for Tagrisso ® (Osimertinib) for adjuvant treatment after complete tumour resection in patients with non-small cell lung cancer (NSCLC), whose tumours have epidermal growth factor receptor (EGFR) mutations. Gagandeep Singh Bedi, Managing Director, Astrazeneca India, said “The regulatory approval of Tagrisso® (Osimertinib) in India will provide better medicine for the management of non-small cell lung cancer and help patients attain a better quality of life.” Osimertinib, a once daily oral pill, when given in patients of lung cancer, whose tumour have specific mutation called EGFR mutation and who have undergone surgical removal of the lung tumour, has shown to decrease the risk of  cancer recurrence by nearly 83 per cent in the ADAURA® clinical trial in early stage lung cancer patients. Osimertinib is the first targeted oral treatment option to show such a significant benefit in terms of cancer free survival in early lung cancers with EGFRm positivity. Cancer spread to the brain and other organs is one of the important cause of recurrence in early stage lung cancer. Osimertinib has shown to decrease the chances of cancer spreading to the brain & other distant organs. Gagandeep Singh Bedi, Managing Director, Astrazeneca India, said “AstraZeneca has always been and will continue to bring forward world-class treatment solutions for non-communicable diseases. The regulatory approval of Tagrisso® (Osimertinib) in India will provide better medicine for the management of Non-Small Cell Lung Cancer and help patients attain a better quality of life.” Dr Anil Kukreja, Vice President – Medical Affairs & Regulatory, AstraZeneca India said, “The approval of Osimertinib  as an adjuvant treatment for EGFRm NSCLC in India, will provide the much needed treatment choice for patients in early lung cancers with EGFRm positivity. The approval will provide oncologists with potential therapeutic option to be given with curative intent to eligible select early lung cancer patients.” ]]> <![CDATA[Lupin launches authorised generic version of Alinia®]]> https://biospectrumindia.com/news/95/18239/lupin-launches-authorised-generic-version-of-alinia.html https://biospectrumindia.com/news/95/18239/lupin-launches-authorised-generic-version-of-alinia.html Wed, 10 Mar 2021 16:40:00 +0530 Lupin Limited has announced the launch of the authorised, generic version of Alinia® (nitazoxanide) Tablets, 500 mg of Romark Laboratories, LC. Nitazoxanide Tablets, 500 mg, are indicated in the treatment of diarrhoea caused by Giardia lamblia or Cryptosporidium parvum in patients 12 years of age and older. Nitazoxanide Tablets, 500 mg (RLD: Alinia®) had estimated annual sales of $56 million in the US (IQVIA MAT January 2021). ]]> <![CDATA[Meril Life Sciences unveils bioresorbable scaffold MeRes100 in India]]> https://biospectrumindia.com/news/95/18238/meril-life-sciences-unveils-bioresorbable-scaffold-meres100in-india.html https://biospectrumindia.com/news/95/18238/meril-life-sciences-unveils-bioresorbable-scaffold-meres100in-india.html Wed, 10 Mar 2021 16:35:00 +0530 Meril Life Sciences has announced the launch of its indigenously researched and developed bioresorbable scaffold (BRS) MeRes100 in India. Bioresorbable scaffolds are non-metallic, non-permanent mesh tubes, similar to stents, that dissolve over time after ensuring the previously blocked artery is opened via a routine angioplasty procedure. This novel therapy option, which can meaningfully treat an identified subset of the patient population, will be launched in a phased, sequential manner to ensure adherence to best clinical practices and continued development of clinical research and long-term evidence. Currently, MeRes100 is being launched in 16 cities across India, including Mumbai, Delhi, Gurugram, Bengaluru, Chennai, Pune, Hyderabad, Ahmedabad, Lucknow, Chandigarh, Mohali, Jaipur, Kochi and Eddakad (in Kerala), Nagpur and Bhubaneswar. Sanjeev Bhatt, Sr Vice President, Corporate Strategy, Meril Life Sciences, commented, “We will facilitate a multi-national, multi-centre, randomised clinical trial, MeRethon RCT, comparing MeRes100 to conventional drug eluting stents. Approximately 2,000 patients will undergo clinical, angiographic and OCT imaging follow-ups over five years, to establish long term clinical evidence of BRS therapy and its benefits.” MeRes100 is the first-ever 100 micron thin-strut BRS developed to treat people with coronary artery disease. Till date, it has been granted a total of 12 patents from the US, Japan, Australia, Russia, Europe, Korea, China, Brazil and India. Backed by multi-year safety and efficacy data from Indian and international trials, MeRes100 has received DCGI approval as well as European CE approval.  Dr Praveen Chandra, Chairman- Interventional Cardiology, Medanta- The Medicity, Gurugram, India, and Co-Principal Investigator of the MeRes-1 Study, commented, “With appropriate patient and lesion selection, bioresorbable or dissolvable stent technology can bridge the gap between the temporary horizon required for healing a blockage and the permanent nature of a metallic stent implant.” ]]> <![CDATA[Lupin, Endoceutics focus on women's health in Canada]]> https://biospectrumindia.com/news/95/18231/lupin-endoceutics-focus-on-womens-health-in-canada.html https://biospectrumindia.com/news/95/18231/lupin-endoceutics-focus-on-womens-health-in-canada.html Tue, 09 Mar 2021 13:15:00 +0530 Lupin Pharma, a subsidiary of global pharma major Lupin Ltd, has announced a partnership with Endoceutics, a women’s health focused innovative Canadian biotech company, to commercialise Intrarosa® in Canada.  Intrarosa® is Endoceutic’s flagship product indicated for the treatment of postmenopausal vulvovaginal atrophy offered as a vaginal ovule containing 6.5 mg of Prasterone. Commenting on the partnership, Dr Sofia Mumtaz, President, Lupin Pharma Canada said, “We are very pleased to partner with Endoceutics to bring this long-awaited innovative product to the Canadian market. Intrarosa will not only expand and strengthen our product portfolio into women’s health in Canada but will cater to satisfy the unmet medical needs.” “We are very excited to be working closely with Lupin in Canada. We believe they are the right partner to successfully bring Intrarosa to the market,” commented Dennis Turpin, President and Chief Executive Officer, Endoceutics.  It is estimated that over 50 per cent of postmenopausal women suffer from the symptoms of vulvovaginal atrophy and that less than 10 per cent of these women are treated with prescription medicines. ]]> <![CDATA[Piramal Pharma forays into feminine hygiene with launch of gentle intimate wash]]> https://biospectrumindia.com/news/95/18225/piramal-pharma-forays-into-feminine-hygiene-with-launch-of-gentle-intimate-wash.html https://biospectrumindia.com/news/95/18225/piramal-pharma-forays-into-feminine-hygiene-with-launch-of-gentle-intimate-wash.html Mon, 08 Mar 2021 15:10:00 +0530 Piramal Pharma Limited’s Consumer Products Division has announced its entry into feminine intimate care category with the launch of ‘i-feel® gentle intimate wash’. The product will initially be available in the West Bengal market and on all leading e-commerce platforms. The company has also announced its association with Yami Gautam, an established actress of the Indian Film Industry, as the brand ambassador for ‘i-feel®'. Piramal’s 'i-feel®' gentle intimate wash is free of sulphates, paraben and alcohol which makes it gentle and safe for a woman’s intimate area. It contains lactic acid that helps maintain vaginal pH balance and is enriched with Neem, Tulsi and Tea Tree oil that keep infections and irritation away.  Commenting on this announcement, Nandini Piramal, Chairperson, Piramal Pharma Limited said, “We are confident that the launch of Piramal’s 'i-feel®' would provide women a contemporary and trusted solution for their intimate hygiene needs.” Speaking on her association with Piramal’s ‘i-feel®', Gautam said, “Intimate hygiene plays a key role in the overall well-being of a woman. I am pleased to associate with Piramal’s 'i-feel®', a gentle intimate wash which understands the needs of today’s woman and helps in maintaining one’s daily intimate hygiene to prevent odour, infection and irritation.   ]]> <![CDATA[Windlas Biotech, Mateon Therapeutics launch complete respiratory wellness solution]]> https://biospectrumindia.com/news/95/18220/windlas-biotech-mateon-therapeutics-launch-complete-respiratory-wellness-solution.html https://biospectrumindia.com/news/95/18220/windlas-biotech-mateon-therapeutics-launch-complete-respiratory-wellness-solution.html Mon, 08 Mar 2021 08:45:00 +0530 Gurugram based Windlas Biotech, in partnership with Mateon Therapeutics in the US, has launched an innovative drug-device therapy PulmoHeal + ARTIHealth as a complete respiratory wellness solution. In a first, the AI-app based platform ARTIHealth™, developed by Mateon Therapeutics will enable patients to monitor the progress of their respiratory function over time by enabling them to upload daily cough and speech recording and receiving feedback on the health of their lungs. The platform is a self-assessment and monitoring tool that provides >90 per cent accurate feedback used for suitable self-care and remote healthcare. This is part of a long-term joint development agreement with IBM Watson Health Research and Mateon.  The platform will also collect large-scale, clinical data through a post-marketing survey (PMS) platform through which we are empowering consumers and patients as active participants in the development of PulmoHeal for future indications including COVID-19, COPD, and asthma. Interim results from the clinical study called ARTI-19 conducted by Windlas and Mateon suggest PulmoHeal to be highly effective in significantly reducing respiratory distress and has demonstrated efficacy against COVID-19 as well. These results have been published in prestigious peer-reviewed journals Frontiers in Pharmacology and Clinical Investigations. The trials were carried out on 120 patients across three hospitals in Andhra Pradesh and Maharashtra. Hitesh Windlass, MD, Windlas Biotech, commented, “PulmoHeal might have the potential to fight a broad spectrum of respiratory viruses. Our new drug-device platform will be a game-changer and will significantly reduce the burden on health systems.” Dr Vuong Trieu, CEO and Chairman, Mateon said, “Artemisinin is a highly promising TGF-β inhibitor and opens the way to alleviating many respiratory illnesses.” The research is supported by Chopra Foundation, a non-profit organisation, dedicated to improving health and well-being. Interim findings on the clinical trial of Ayurvedic variant of PulmoHeal, ARTIVeda have been submitted to AYUSH authorities for medical evaluation. ]]> <![CDATA[Shilpa Medicare launches women’s intimate cleansing spray]]> https://biospectrumindia.com/news/95/18216/shilpa-medicare-launches-womens-intimate-cleansing-spray.html https://biospectrumindia.com/news/95/18216/shilpa-medicare-launches-womens-intimate-cleansing-spray.html Fri, 05 Mar 2021 00:00:00 +0530 Raichur based Shilpa Medicare has announced the launch of its new women’s intimate cleansing spray ‘Swatchshil’ that aims to revolutionise the concept of personal hygiene for women in India. An anti-bacterial, anti-fungal solution, ‘Swatchshil’ is India’s first spray-based intimate hygiene product. ‘Swatchshil’ is a soap-free, alcohol-free spray that ensures impeccable vaginal hygiene and offers high degree of protection against bacterial and fungal infections. It also balances the vaginal pH between 3.5 to 4.5 thereby ensuring natural microbial balance and preventing vaginal issues such as foul odour, excessive white discharge, itching and irritation. “We also want to use the launch of this product to generate greater awareness about women’s intimate hygiene in India and educate them about the right hygiene practices. The spray comes with the advanced bag on valve delivery system, actuator packaging technology imported from Germany that makes its use highly convenient and safe,” said Vishnukant Bhutada, MD, Shilpa Medicare Ltd. Swatchshil contains unique combination of three good ingredients with antimicrobial properties that not only protects against infections but also helps moisturise the sensitive vaginal area. They are non-antibiotic bactericide, which while providing a broad-spectrum protection against bacterial and fungal infections offer no drug resistance. It also promotes the self-cleansing of the vagina and repair of muscular tissues. The product is available both on prescription as well as over-the-counter. It is being made available across medical as well as non-medical retail outlets across the country. At the same time, the company is also making it widely available through e commerce channels including healthcare and women’s e-retail outlets such as Amazon, Flipkart, 1mg, Myntra, as well as on SwatchShil’s official website-www.shilpacare.in. ]]> <![CDATA[Rockwell launches COVID-19 freezer series powered by hybrid renewable energy ]]> https://biospectrumindia.com/news/95/18211/rockwell-launches-covid-19-freezer-series-powered-by-hybrid-renewable-energy-.html https://biospectrumindia.com/news/95/18211/rockwell-launches-covid-19-freezer-series-powered-by-hybrid-renewable-energy-.html Thu, 04 Mar 2021 17:05:00 +0530 Hyderabad headquartered Rockwell Industries, a pioneering commercial cold chain appliances manufacturer, has launched CHILLERMILL®, the world’s first chiller/freezer powered by hybrid (solar & wind) renewable energy, that would be ideal for storing vaccines, lifesaving medicines, including those for COVID-19 vaccines at the desired temperature. The company also rolled out their new COVID-19 vaccine freezer series. The intelligently designed Rockwell’s CHILLERMILL®, and WHO PQS (World Health Organisation PQS) certified the new COVID-19 freezer series will be manufactured at its state-of-the-art manufacturing facility in Medchal, Hyderabad. The entire system is certified by the National Institute of Pharmaceutical Education & Research (NIPER) Hyderabad. Jayesh Ranjan, Principal Secretary, Government of Telangana for the Industries & Commerce (I&C) and Information Technology (IT), formally launched the new range of COVID-19 vaccines chillers, a simple plug and play standalone unit, powered by SolarMill® a hybrid (Wind & Solar) energy solution, manufactured by WindStream Energy Technologies ideal for remote areas where availability of electricity is not stable. The hybrid renewable system comprising Savonius vertical axis wind turbines, along with a solar module enables the refrigerator to run 24/7 on power stored in batteries.   Ranjan said “Governments and immunisation programmes rely on complicated cold chain of freezers and temperature-controlled conditions and Rockwell has developed the much-needed refrigeration technology to address these challenges to preserve vaccine, healthcare products, and other deep-freezing applications.” Ashok Gupta, Managing Director, Rockwell Industries said “There are places especially, many rural hospitals and immunisation sites that can’t depend on the unreliable power supply. With our new renewable energy-supported freezers/chillers, we are in a position to help the health sector overcome these challenges.” The company is in active discussion with leading vaccine players nationally & internationally to supply CHILLERMILL®. ]]> <![CDATA[COVAXIN shows 80.6 per cent efficacy in Ph 3 trials ]]> https://biospectrumindia.com/news/95/18207/covaxin-shows-80-6-per-cent-efficacy-in-ph-3-trials-.html https://biospectrumindia.com/news/95/18207/covaxin-shows-80-6-per-cent-efficacy-in-ph-3-trials-.html Wed, 03 Mar 2021 23:05:00 +0530 Bharat Biotech has announced the first interim analysis of its BBV152 (COVAXIN®). The whole virion inactivated COVID-19 vaccine candidate demonstrated an interim vaccine efficacy of 81 per cent in its Phase 3 clinical trial. The trials involved 25,800 subjects, the largest ever conducted in India, in partnership with the Indian Council of Medical Research. “With today’s results from our Phase 3 clinical trials, we have now reported data on our COVID-19 vaccine from Phase 1, 2, and 3 trials involving around 27,000 participants,” said Dr Krishna Ella, Chairman & Managing Director, Bharat Biotech. “I want to thank every one of the participants, who volunteered to participate in this vital clinical trial, our partners, principal investigators across 25 study sites, and our team at Bharat Biotech who dedicated their time to this vaccine discovery,” said Suchitra Ella, Joint Managing Director, Bharat Biotech.   The Phase 3 study enrolled 25,800 participants between 18-98 years of age, including 2,433 over the age of 60 and 4,500 with comorbidities. The primary endpoint of Phase 3 clinical trial is based on the first occurrence of PCR-confirmed symptomatic (mild, moderate, or severe) COVID-19 with onset at least 14 days after the second study vaccination in serologically negative (to SARS-CoV-2) adult participants at baseline. The first interim analysis is based on 43 cases, of which 36 cases of COVID-19 were observed in the placebo group versus seven cases observed in the BBV152 (COVAXIN®) group, resulting in a point estimate of vaccine efficacy of 80.6 per cent. Analysis from the National Institute of Virology indicates that vaccine-induced antibodies can neutralise the UK variant strains and other heterologous strains, which has been published in bioRxiv.   Bharat Biotech expects to share further details of the trial results as additional data become available. An additional interim analysis is planned for 87 cases, and the final analysis is planned for 130 cases.   ]]> <![CDATA[ManipalCigna launches ManipalCigna Lifetime Health plan]]> https://biospectrumindia.com/news/95/18204/manipalcigna-launches-manipalcigna-lifetime-health-plan.html https://biospectrumindia.com/news/95/18204/manipalcigna-launches-manipalcigna-lifetime-health-plan.html Wed, 03 Mar 2021 19:05:00 +0530 ManipalCigna Health Insurance Company Limited has announced the launch of 'ManipalCigna Lifetime Health' plan. This new regular premium lifetime renewable plan is thoughtfully designed after a period of research which identified that post COVID-19 pandemic, consumer conversation has finally changed from 'do I need health insurance' to 'how much do I need'. Thus keeping in mind the increasing healthcare incidences and cost, the plan offers the benefit of high coverage, optional packages and provides a comprehensive healthcare financing solution to secure an individual's and a family's domestic and global healthcare requirements at every stage of life. Speaking about the product launch, Prasun Sikdar, Managing Director and CEO, ManipalCigna Health Insurance Company Limited, said, "The plan comes with two variants Lifetime Health India Plan and Lifetime Health Global Plan that offers a high level of protection with sum insured ranging from Rs 50 lakh to Rs 3 crore to give people financial access to cover advanced treatments and procedures, globally, for up to 27 major illnesses, and most importantly looks after their unique healthcare requirements for a lifetime.” Sikdar further added, "The new plan lets you customise the cover you need for your family using optional packages like Health+, Women+ and Global+ along with critical illness rider that provides extensive coverage like screenings, vaccinations, and many more healthcare benefits thus keeping you and your family clear of financial burden for lifetime.” ]]> <![CDATA[Lupin ropes in JIFFY.ai to expand automation initiatives]]> https://biospectrumindia.com/news/95/18202/lupin-ropes-in-jiffy-ai-to-expand-automation-initiatives.html https://biospectrumindia.com/news/95/18202/lupin-ropes-in-jiffy-ai-to-expand-automation-initiatives.html Wed, 03 Mar 2021 18:15:00 +0530 Global pharma major Lupin Limited and Silicon Valley-based enterprise automation start-up JIFFY.ai have announced a formalised partnership where JIFFY.ai will help to strategically expand Lupin's automation initiatives. This agreement will provide Lupin with the ability to evolve their internal operations via JIFFY.ai's AUTOMATE platform, which provides cloud-native, low-code integrated solutions. JIFFY.ai will help digitise Lupin data and processes by seamlessly integrating built-in machine learning (ML), robotic process automation (RPA) and intelligent document processing. The power of JIFFY.ai's AUTOMATE platform will accelerate Lupin's back-end operational efficiency by saving employee time, improving productivity and enhancing process quality outcomes. Babu Sivadasan, Co-founder, CEO, JIFFY.ai., said, "We look forward to co-developing solutions for Lupin that are optimised for a pharmaceutical environment. These new applications of our technology will save employees' time and effort, allowing them to focus on what really matters.” The JIFFY.ai AUTOMATE platform empowers organisations to digitise their data and seamlessly integrate built-in automation technologies to address the entire automation lifecycle. It leverages intelligent document processing, artificial intelligence, machine learning, natural language processing, business process management workflows and business analytics to deliver end-to-end process automation experience. This allows enterprise users to accelerate their innovation and evolve their processes, making operations more time-efficient and cost-effective with better quality and precision. "We are excited to partner with JIFFY.ai for our automation and digital transformation journey. We are looking forward to leveraging the capabilities of the platform like AI-ML, doc processing, analytics for automating many complex processes, thereby providing our stakeholders intelligent and seamless ways of operating," said Sreeji Gopinathan, Global CIO, Lupin.  ]]> <![CDATA[GSK rolls out multilingual paediatric vaccination awareness campaign on Public App]]> https://biospectrumindia.com/news/95/18199/gsk-rolls-out-multilingual-paediatric-vaccination-awareness-campaign-on-public-app.html https://biospectrumindia.com/news/95/18199/gsk-rolls-out-multilingual-paediatric-vaccination-awareness-campaign-on-public-app.html Wed, 03 Mar 2021 16:55:00 +0530 In a bid to increase awareness around the importance of paediatric vaccination, GlaxoSmithKline Pharma rolled out a massive public interest campaign called ‘Health ka Passport’ on Public App across all major Indian languages. The ad campaign seeks to educate caregivers of children on the importance of timely vaccination and maintenance of records to ensure that children are not susceptible to preventable diseases. The campaign generated over 78 lakh views, with an impressive industry best CTR rate of 1.14 per cent. Speaking about the campaign on behalf of GSK, Mayank Khaneja, Associate Director - Publicis Groupe, said, “To create awareness around vaccines, GSK - a leading pharmaceutical company, took the initiative to provide vital information on the importance of timely vaccinations and given the language diversity in India, we needed a credible platform that can spread this message in the deepest pockets of the country and therefore Public App was one of the most apt choice for us.” Under the ‘Health Ka Passport’ campaign, users could view and download a series of informative cards outlining the vaccination schedule from birth to eighteen years of age, and busting myths regarding vaccinations. Users also get a clickable link directing them to www.gskprotect.in for further information. Commenting on the campaign, Harshil Dhingra, Chief Business Officer, Public App said, “Health Ka Passport was our pilot campaign on Public App and we thank GSK Pharma for reposing their trust in us to reach the right audience and spread the critical message of paediatric vaccination.” Public App is India’s largest location based social network with 50 million+ active users.   ]]> <![CDATA[ICPA Health launches antibiotic to treat odontogenic infections]]> https://biospectrumindia.com/news/95/18191/icpa-health-launchesantibiotic-to-treat-odontogenic-infections.html https://biospectrumindia.com/news/95/18191/icpa-health-launchesantibiotic-to-treat-odontogenic-infections.html Tue, 02 Mar 2021 12:40:00 +0530 Mumbai based ICPA Health Products Ltd (ICPA), a leading pharmaceutical company and pioneers in the oral-health segment, has launched ICPAMOX – CV 625 meant to treat odontogenic infections. The product is an antibiotic with a broad-spectrum activity against the commonly occurring bacterial pathogens in the oral cavity and other parts of the body. An antibiotic indicated in multiple conditions, ICPAMOX – CV 625 is recommended for use along with dental treatments like root canal, tooth extractions and various oral surgeries to reduce post-operative infection. The product composition is Amoxycillin 500mg + Clavulanic acid 125mg and is approved by the DCGI. “The launch of ICPAMOX – CV 625 is a testament to our focus in the oral health care segment. ICPAMOX – CV 625 marks our foray into antibiotics and we plan to introduce more products in the segment. The product is extremely effective for treating odontogenic infections in patients undergoing various types of dental treatments,” says Abha Damani, Director, ICPA. A box of ICPAMOX – CV 625 is available at an MRP of Rs.189/- and contains 10 tablets.   ]]> <![CDATA[6th IPA Forum emphasises on patient-centricity, quality management]]> https://biospectrumindia.com/news/95/18185/6th-ipa-forum-emphasises-on-patient-centricity-quality-management.html https://biospectrumindia.com/news/95/18185/6th-ipa-forum-emphasises-on-patient-centricity-quality-management.html Mon, 01 Mar 2021 17:45:00 +0530 The Indian Pharmaceutical Alliance successfully hosted the 6th edition of the Indian Pharmaceutical Forum. This year’s theme Patient Centricity: New Paradigm in Quality Management highlighted the importance of sustaining patient-centricity from long term perspective.  Dr VG Somani, Drug Controller General of India said “Indian pharmaceutical industry has been proactive to adapt to the situation in regard to production, supply chain etc while maintaining best practices.” The forum addressed various aspects that define quality management in the pharmaceutical industry and brought manufacturers and regulators on a common platform to facilitate discussions resulting in meaningful and actionable outcomes. Satish Reddy, President, Indian Pharmaceutical Alliance said “IPA’s focus right from the start of pandemic clearly has been on ensuring supply chain continuity, welfare of the employees, providing thought leadership and stimulating recovery and growth of the industry.” Pankaj Patel, Chairman, Cadila Healthcare Ltd, said, “Digital interventions have the potential to help us innovate and improve market share. Innovation, not just in molecular developments but also in existing systems of manufacturing, training, data analysis & storage and much more are equally essential.” Nilesh Gupta, MD, Lupin Ltd, said “The industry needs to learn from other sectors which will help in redefining the way pharma manufactures and conducts testing.” Sudarshan Jain, Secretary General, Indian Pharmaceutical Alliance said “This year, the 6th Indian Pharmaceutical Forum provided a platform to facilitate a comprehensive discussion on the ever changing shift in quality management, led by significant voices of the industry.” The event concluded with an exclusive panel discussion on the impact of COVID-19 on pharmaceutical industry that brought together the C-Suite of top Indian pharma such as Cadila Healthcare, Cipla, Dr Reddy’s, Lupin and Sun Pharma.   ]]> <![CDATA[SHARP-QNET launch next gen air purifier in India]]> https://biospectrumindia.com/news/95/18183/sharp-qnet-launch-next-gen-air-purifier-in-india.html https://biospectrumindia.com/news/95/18183/sharp-qnet-launch-next-gen-air-purifier-in-india.html Mon, 01 Mar 2021 16:35:00 +0530 QNET has announced the launch of SmartAir, a new state-of-the-art air purifier model as part of its ongoing  partnership with Sharp Business Systems in India. The new SHARP-QNET SmartAir features Sharp’s patented Plasmacluster Ion Technology (PCI) with proven efficacy in obliterating SARS-CoV-2 by 91.3 per cent within 30 seconds.  The PCI technology has been certified by 33 global labs for its effectiveness in killing deadly viruses, neutralising gases, chemicals, VOCs; destroying several infection-causing pathogens, reducing static charge, and improving skin health. The product is available for sale through QNET’s direct selling distributor network in India. The SHARP-QNET SmartAir has also incorporated IoT functionality that allows it to be connected to Wi-Fi and operated from anywhere on a smartphone through the ‘SHARP Air’ mobile app (available for both Android and iOS users). The app allows users to control their device, pre-set the humidity level, check for information such as air quality, timer setting, filter status and more. Commenting on the new product introduction, Rishi Chandiok, Regional Director (South Asia), QNET Ltd said, “We have a 6-years long relationship with SHARP in India that has only been growing in strength. Our aim is to offer our customers value-added products that will help them live healthier, holistic lives."   The  SmartAir is also equipped with Sharp’s original HAZE Mode for superior and efficient cleaning during smog and high impurity conditions. Priced at Rs 43670, this device is aesthetically designed and features a distinct control panel that is easy to use and looks great in any room. This product's unique 20-degree air flow ensures reach in every corner of the room, with a comprehensive coverage of 450 sq ft. ]]> <![CDATA[Sun Pharma launches website for long-term care division in US]]> https://biospectrumindia.com/news/95/18176/sun-pharma-launches-website-for-long-term-care-division-in-us.html https://biospectrumindia.com/news/95/18176/sun-pharma-launches-website-for-long-term-care-division-in-us.html Fri, 26 Feb 2021 12:35:00 +0530 Sun Pharmaceutical Industries Limited including its subsidiaries and/or associate companies) announced the US launch of the website for its long-term care (LTC) division, www.sunltc.com. The new website presents Sun Pharma's LTC portfolio of alternative formulation products and underscores Sun Pharma's commitment to meeting the needs of the up to 40 per cent of American adults who cannot or will not swallow solid medication forms. Sun Pharma's LTC portfolio includes the first and only US Food and Drug Administration (FDA)-approved extended-release sprinkle formulation of metoprolol succinate; the first and only FDA-approved sprinkle formulation of delayed-release duloxetine; and the first and only approved sprinkle formulation of rosuvastatin, Ezallor Sprinkle™ (rosuvastatin) immediate-release capsules. The Ezallor Sprinkle label was recently updated to allow for sprinkling the capsule contents over pudding (in addition to applesauce) as a soft-food alternative mode of administration.   "Through this website, Sun Pharma aims to call attention to the broad need for our three alternative sprinkle formulations of widely prescribed medications, which are designed for those who cannot or will not swallow solid medication forms," said Mark Hagler, Senior Vice President and Head of Ophthalmics, Oncology and LTC, Sun Pharma. "These products are also being prescribed outside of LTC facilities, suggesting a broader need for alternative administration options of commonly used therapies that cannot be crushed. Our new website highlights the efficacy and safety profile for each product, while also educating healthcare providers and patients about our intent to mitigate risks associated with improper medication manipulation."  ]]> <![CDATA[The Indian pharma industry in need of fundamental reforms: EY-FICCI report]]> https://biospectrumindia.com/news/95/18175/the-indian-pharma-industry-in-need-of-fundamental-reforms-ey-ficci-report.html https://biospectrumindia.com/news/95/18175/the-indian-pharma-industry-in-need-of-fundamental-reforms-ey-ficci-report.html Fri, 26 Feb 2021 00:00:00 +0530 The Indian pharma industry should consolidate on its advantages and undertake fundamental reforms to reset on innovation-led industrial growth to meet the ambition of $130 bn by 2030 says the EY-FICCI report titled, ‘Indian Pharmaceutical Industry 2021: future is now.’  This report reassesses the Indian pharma industry’s positioning and defines India’s ambition by 2030 by identifying a set of imperatives for all stakeholders – the government, pharma and healthcare industry leaders, functional experts of the pharma industry and experts in the allied sectors.  The Indian pharma industry has grown at a compounded growth rate of (CAGR) of ~11 per cent in the domestic market and ~16 per cent in exports over the last two decades. The overall growth has been driven by the industry’s leadership in supplying generic formulations to markets across the globe. In the 2020-2030 period, it is envisaged that the Indian pharma industry will grow at a CAGR of ~12 per cent to reach $130 bn by 2030 from $41.7 bn in 2020.  Sriram Shrinivasan, Global Generics and National Health and Lifesciences Leader, EY, says, “We must take upon ourselves a moon-shot target for the pharma industry in India, whereby all stakeholders come together on one platform and take a pledge of commercialising indigenous novel drugs (both biological and chemical).” Pankaj Patel, Mentor, FICCI Pharma Committee and Chairman & Managing Director, Zydus Cadila said, “An increase in spending by the government on healthcare and investment is necessary with a policy that is clear and coherent resulting in the sustainability of the industry.” The global pharmaceutical trade is expected to reach a size of $1-1.3 trillion by 2030, the ambition is to garner a global share of 6-7 per cent by value to attain a size of ~$73 billion. The opportunities that have emerged to accelerate the growth of Indian pharmaceutical and healthcare industry are - innovation led research and development, healthcare delivery (R&D), manufacturing and supply chain, and market access.   ]]> <![CDATA[Ukraine to firm up COVAXIN delivery plan for mass vaccination]]> https://biospectrumindia.com/news/95/18169/ukraine-to-firm-up-covaxin-delivery-plan-for-mass-vaccination.html https://biospectrumindia.com/news/95/18169/ukraine-to-firm-up-covaxin-delivery-plan-for-mass-vaccination.html Thu, 25 Feb 2021 13:15:00 +0530 A three-member, high-power delegation from Ukraine led by the Dr Maksym Stepanov, Health Minister, Ukraine visited COVAXIN®-maker Bharat Biotech’s manufacturing facility in Hyderabad. The delegation, that included Igor Ivashchenko, Deputy Minister of Health, Ukraine, and Ivan Konovalov, Head of Trade and Economic Dept, Embassy of Ukraine in India, had a discussion with Bharat Biotech’s leadership to secure the supplies of COVAXIN® to Ukraine. Dr Krishna Ella, Chairman & Managing Director, Bharat Biotech International Limited, said, “It was an absolute privilege to host the Hon’ble Minister of Health from Ukraine Dr Maksym Stepanov at our state-of-the-art facility and showcase our world-class capabilities in the manufacture and supply of vaccines and research and product development. We discussed potential timelines for the supply of COVAXIN® to Ukraine on a priority and the prospects of a partnership for our BBV 154 intranasal vaccine.” Dr Stepanov, said, “Ukraine and India have a long history of cooperation in various matters. We look forward to benefiting from India’s vast capability in the manufacture of vaccines to effectively combat the COVID-19 pandemic at home. We will soon firm up the COVAXIN® delivery plan for the mass vaccination of our people, and further strengthen our partnership on intranasal vaccine supplies after initial results from its phase 1 trials.” ]]> <![CDATA[Blue Star launches free diagnostic programme for underprivileged women]]> https://biospectrumindia.com/news/95/18161/blue-star-launches-free-diagnostic-programme-for-underprivileged-women.html https://biospectrumindia.com/news/95/18161/blue-star-launches-free-diagnostic-programme-for-underprivileged-women.html Wed, 24 Feb 2021 12:10:00 +0530 Air conditioning and commercial refrigeration major, Blue Star Limited’s wholly owned subsidiary Blue Star Engineering & Electronics Limited has announced, as a part of its CSR initiative, the launch of its free diagnostic programme, ‘Blue Star Engineering & Electronics Diagnostic Support Programme,’ through which it intends to partner with diagnostic centres across India to help women from the underprivileged sections of society by providing them with free diagnostic support to detect chronic diseases. Currently, under this programme, the company by partnering with diagnostic centres, is providing free diagnostic support to women from economically challenged families, who are in need of cancer related diagnostic tests and screenings (free diagnostic services comprising MRI and CT scan costing up to Rs 4,500 in any of the three partner hospitals). The said programme has been rolled-out in partnership with eminent cancer centres in India from February 2021, which is the National Cancer Prevention Awareness Month, and will go on till June 2021, during which support will be provided to around 900 women, in total. With cancer cases on a continuous rise in India, and with ‘cancer diagnosis’ being the critical factor in ‘cancer treatment,’ this time, the company decided to support the cause of ‘cancer diagnosis,’ as early diagnosis will help these women receive timely treatment. For this initiative, Blue Star Engineering & Electronics has partnered with the following hospitals where women in need can avail free diagnostic services pertaining to cancer detection: All India Institute of Medical Sciences (AIIMS), Rishikesh, Uttarakhand (Northern Region) The Cancer Institute, Adyar, Chennai, Tamil Nadu (Southern Region) The Kailash Cancer Hospital, Goraj, Vadodara, Gujarat (Western Region) ]]> <![CDATA[Pregna introduces economical solution to post-partum haemorrhage]]> https://biospectrumindia.com/news/95/18154/pregna-introduces-economical-solution-to-post-partum-haemorrhage.html https://biospectrumindia.com/news/95/18154/pregna-introduces-economical-solution-to-post-partum-haemorrhage.html Tue, 23 Feb 2021 17:25:00 +0530 Mumbai based Pregna International Ltd has partnered with Dr Thomas Burke’s Vayu Global Health Initiative to introduce an economical solution to post-partum haemorrhage (PPH) – one of the leading causes of maternal mortality. Dr Burke and his teams at the Massachusetts General Hospital, Harvard University and the Vayu Global Health Foundation have worked on developing studying an effective and inexpensive solution which is user friendly and can be used even in low-resource settings. Dr Burke commented on this partnership – “We have been working on the UBT kit for the past 12 years and we are excited to partner with Pregna to make it available on a large scale to health workers all over the world.” Speaking about the work, Ajit Raje, Vice President, Pregna stated, “While UBT is a great invention and is very useful in managing most cases of PPH, notably shown in the improvements in mortality rates in parts of Asia, most devices available in the market today are priced at a premium, which limits its effectiveness. Dr Burke and his team have broken the pricing barrier.” Speaking about the partnership, Mukul Taparia, Managing Director, Pregna noted, “Pregna will bring its manufacturing, marketing & regulatory expertise to elevate its scalability and maximise its reach.” Pregna expects to launch Dr Burke’s ESM-UBT kit in the second quarter of 2021. The product is US FDA certified and has undergone many trials. ]]> <![CDATA[Telangana partners with Cytiva to strengthen biopharma industry]]> https://biospectrumindia.com/news/95/18151/telangana-partners-with-cytiva-to-strengthen-biopharma-industry.html https://biospectrumindia.com/news/95/18151/telangana-partners-with-cytiva-to-strengthen-biopharma-industry.html Tue, 23 Feb 2021 00:00:00 +0530 Cytiva, a global life science leader, and the State of Telangana in India will work together to open a new Fast Trak lab. The city of Hyderabad in Telangana, which has emerged as a leader in pharmaceuticals and biotechnology, is well-positioned to host such a facility. The 10,000 square foot lab, to be located in the Genome Valley, will accelerate and advance the local biopharma scale up needs. The 10,000 square foot lab, to be located in the Genome Valley, will accelerate and advance the local biopharma scale up needs.   With over 800 life sciences companies nearby, the new facility will help the area’s biotechnology hub increase production efficiency, reduce cost and speed to market.  India's biotechnology industry, estimated to reach 150 billion dollars by 2025, expects to see the number of emerging biotech companies boom from 3,475 to more than 10,000. The State of Telangana has a rich mix of global pharmaceutical companies, Indian local biopharma giants, and biotech startups. Combined, they contribute about 35% of India’s pharmaceutical production.  Cytiva’s Fast Trak lab is ready to meet the area’s fast-growing demand.  Vaggu Raghavendra Goud, General Manager of Cytiva South Asia, says: “Cytiva has been growing alongside the Indian biotechnology industry for more than 30 years. A Fast Trak lab brings us closer to our customers in one of the world’s key biotechnology hubs.  This partnership enables us to share our global knowledge and expertise at a regional level. It is a new milestone in our continued investment in the India market and another way we fully support the growth of the industry here.”  Shakti Nagappan, Director of Life Sciences and Pharma, the State Government of Telangana, says: “The government of Telangana has conceptualized Biopharma-Hub (B-Hub) as a Growth Phase Park to provide necessary support to young companies graduating from incubation stage along with this biopharma scale-up manufacturing facility of about 200L to help companies produce clinical material (phase 1 & 2). The scale-up facility will also provide training, which is a key requirement to facilitate the growth of biosimilars in the life sciences industry. We are happy to partner with Cytiva for this.” With this collaboration with the State of Telangana, Cytiva continues its partnerships with the key players in the India biotechnology ecosystem.  Together, they will work to address global demand and enable and accelerate industry development. ]]> <![CDATA[Windlas Biotech, Mateon Therapeutics launch integrated solution for respiratory wellness in India]]> https://biospectrumindia.com/news/95/18148/windlas-biotech-mateon-therapeutics-launch-integrated-solution-for-respiratory-wellness-in-india.html https://biospectrumindia.com/news/95/18148/windlas-biotech-mateon-therapeutics-launch-integrated-solution-for-respiratory-wellness-in-india.html Mon, 22 Feb 2021 16:15:00 +0530 Windlas Biotech Pvt Ltd, a leading Indian pharmaceutical contract drug development and manufacturing organisation, in partnership with Mateon Therapeutics, Inc, a US-based oncology company focusing on TGF-β inhibitors as therapies against cancers and infectious diseases, launched a first-of-its-kind integrated solution for respiratory wellness in India. The product, PulmoHeal™ is a broad-spectrum, lung therapy food supplement that is supported by a multi-centre rigorous clinical study and integrated with its own telemedicine AI based platform to offer continuous 360 care for patients in India. Developed from extract of indigenous plant Artemisia, the active component of PulmoHealTM, Artemisinin, has been known to exhibit multiple pharmacological activity against inflammation, viral infections, and lung repair. Available on online channels, Amazon, Flipkart and 1mg.com from February 28. The combined drug + AI telemedicine 360 solution is being launched to transform respiratory illness. Hitesh Windlass, MD, Windlas Biotech, commented, "PulmoHealTM is a unique combination of cutting-edge manufacturing, clinical drug development, and artificial intelligence (AI), which harnesses the power of traditional and modern science. The ARTIHealthTM model can be replicated for a range of therapies including monitoring COVID-19 infection.” Saran Saund, CBO, Mateon, commented, “We are optimistic that our solution will be beneficial even beyond current pandemic by empowering the patients and reducing burden on health care providers.” Dr Vuong Trieu, CEO and Chairman, Mateon said, "We are pleased to be able to leverage on the deep tradition of Indian medicine and advance artificial intelligence & supercomputing technologies under one umbrella to create this innovative solution to healthcare, one which we hope to replicate throughout the world across multiple indications.”  ]]> <![CDATA[Dr Reddy’s initiates EUA process with DCGI for Sputnik V]]> https://biospectrumindia.com/news/95/18144/dr-reddys-initiates-eua-process-with-dcgi-for-sputnik-v.html https://biospectrumindia.com/news/95/18144/dr-reddys-initiates-eua-process-with-dcgi-for-sputnik-v.html Mon, 22 Feb 2021 12:05:00 +0530 Dr Reddy’s Laboratories Ltd has announced that it has initiated the process with the Drugs Controller General of India (DCGI) for emergency use authorisation (EUA) of the well-studied human adenoviral vector-based platform vaccine candidate, Sputnik V.  As part of the review process, Dr Reddy’s will present the safety profile of the phase 2 study, and interim data of the phase 3 study, which was expected to complete by February 21, 2021. The vaccine is currently undergoing the phase 3 clinical trial in India.  GV Prasad, Co-chairman and Managing Director, Dr. Reddy’s Laboratories said, “The initiation of the EUA process will be a critical step forward for us in ensuring speedy access to the Sputnik V vaccine in India.” ]]> <![CDATA[LifeCell announces special offers on its newborn screening package]]> https://biospectrumindia.com/news/95/18136/lifecell-announces-special-offers-on-its-newborn-screening-package.html https://biospectrumindia.com/news/95/18136/lifecell-announces-special-offers-on-its-newborn-screening-package.html Fri, 19 Feb 2021 17:15:00 +0530 Early detection and intervention are key for treating childhood on-set disorders. In an effort to create awareness about the same, LifeCell, India’s largest stem cell bank announced special offers on its newborn screening package. Aligned with Rare Disorder Awareness month, the offer encourages parents to enrol with LifeCell and have their newborn babies screened for life-threatening ailments with additional upgrades at no cost.   Newborn screening is a programme that identifies babies at risk of having rare, but serious medical conditions that can affect normal development. BabyShield Newborn Screening combines biochemical testing of 100+ metabolic & genetic conditions with confirmatory genetic testing for screen-positive results. It aims to achieve the early identification of conditions. Thus, resulting in early intervention that can lead to efficient management and diagnosis and thereby reducing the economic liability too. LifeCell’s NBS is the world’s first integrated DNA testing for newborn screening to detect over 50 medical conditions. This technology has been proven to be more accurate than current screening methods and has also been found to drastically reduce false-positive reporting thereby avoiding unnecessary follow-up tests and anxiety of the parents. The test provides more accurate results and also saves time & effort enabling a speedy diagnosis to initiate treatment. More importantly, the parents are alerted to the risk only if the DNA tests are positive thereby reducing parental anxiety. ]]> <![CDATA[OMRON Healthcare India opens experience-cum-service centre in Hyderabad]]> https://biospectrumindia.com/news/95/18134/omron-healthcare-india-opens-experience-cum-service-centre-in-hyderabad.html https://biospectrumindia.com/news/95/18134/omron-healthcare-india-opens-experience-cum-service-centre-in-hyderabad.html Fri, 19 Feb 2021 16:10:00 +0530 OMRON Healthcare India has announced the launch of its next experience cum service centre in the country at Hyderabad. With this centre, OMRON now has 64 touch points across India including experience, service and pick-up centres. Commenting on the announcement, Masanori Matsubara, MD, OMRON Healthcare India, said, “With growing advancements in technology and the changing dynamics around preventive healthcare in the post Covid era, customers need to get hands-on experience so that they are able to make preventive healthcare management an integral part of their daily regime.” The centre is equipped with an ‘experience zone’ for customers offering live demo for a wide range of OMRON products. It is expected to address 100+ customers on a daily basis initially, where they will be provided with quick resolution of queries and complete know-how on the utility of products. Sharing more on the objectives of the launch, Rohit Saini, GM- Sales & Marketing, OMRON Healthcare India, said, “The objective is to make them experience the technology themselves so that they adopt it swiftly and also get a better customer service experience. This is in sync with our overarching objective of helping them lead a healthy lifestyle in the new normal.” Matsubara also highlighted that the facility indicates one more step of OMRON towards realising its long term ‘zero events’ vision (no incidence of heart attacks & brain strokes) by strengthening the availability and practice of home healthcare monitoring via provision of quality medical devices to Indian society like digital blood pressure monitors, nebulisers, thermometers, nerve stimulators, body fat monitors, weighing scales, etc.   ]]> <![CDATA[PerkinElmer launches cell painting comprising PhenoVue™ cellular imaging reagents portfolio ]]> https://biospectrumindia.com/news/95/18133/perkinelmer-launches-cell-painting-comprising-phenovue-cellular-imaging-reagents-portfolio-.html https://biospectrumindia.com/news/95/18133/perkinelmer-launches-cell-painting-comprising-phenovue-cellular-imaging-reagents-portfolio-.html Fri, 19 Feb 2021 12:40:00 +0530 PerkinElmer, Inc has launched the first cell painting kit as part of its new portfolio of PhenoVue™ cellular imaging reagents. This new range of reagents leverages PerkinElmer’s expertise in cellular imaging and high-content screening and works alongside the company’s microplates, automation, software and industry-leading high-content screening instruments. Cell painting is a powerful application of high-content screening technology which combines cell and computational biology to study the effects of perturbagens such as chemical compounds, drugs or genes on the behaviour of cells. Cells are ‘painted' by labelling cellular compartments with different fluorescent bioprobes to enable those areas to be quantitatively profiled. However, preparing reagents from scratch can be incredibly time consuming. Helping to address this challenge, the PhenoVue™ cell painting kit provides convenience and simplicity through a ready-to-use format and is part of a new range of reagents that also includes fluorescent organelle staining probes and dye-labelled secondary antibodies. These reagents are validated for high-content screening applications to reduce customers’ assay development time. “Researchers are using high-content screening and cell painting to make extraordinary discoveries that will help drive more innovative drugs and therapies,” said Alan Fletcher, Vice President and GM of Life Sciences, PerkinElmer. “With the addition of our new PhenoVue™ cellular imaging reagents, we now offer a complete suite of high-content screening products and expert services. This will help researchers build more streamlined workflows and enjoy the convenience of working with a single, expert technology provider helping to accelerate discovery.”   ]]> <![CDATA[HEAL Group, ESI Med-Tech launch marketing solutions for med-tech industry]]> https://biospectrumindia.com/news/95/18119/healgroup-esi-med-tech-launch-marketing-solutions-for-med-tech-industry.html https://biospectrumindia.com/news/95/18119/healgroup-esi-med-tech-launch-marketing-solutions-for-med-tech-industry.html Wed, 17 Feb 2021 16:00:00 +0530 COVID-19 has created a huge disruption to the healthcare segment globally, in general, and to India, in particular. Poor allocations to healthcare historically, have brought enormous stress on the Indian Healthcare system. However, aggressive involvement by the government, private sector and technology experts have bridged the gap significantly through innovations across various sub-sectors of healthcare. Dr Swadeep Srivastava, Founder and CEO - HEAL Health Connect Solutions says, “HEAL in collaboration with ESI Med-Tek has launched the advisory services to sail through such challenges. The ‘HEAL Health Med-Tech Advisory’ division would not only help with tactical solutions such as device registration & approvals but also provide mentorship for a successful launch and go-to-market strategy.” Dr P Siva Kumar, Med-Tech Advisor - ESI Med-Tek Solutions says, “Several mid-level multinational companies demonstrate an eagerness to enter the Indian market with their technologically innovative products. However, due to lack of proper understanding and guidance, a significant number of these mid-level companies are hesitant to enter the market. The Med-Tech advisory partnership with HEAL would fill this vacuum and handhold foreign companies through Indian processes to enter Indian market.” “Our newly launched services would bridge this gap and ensure appropriate penetration into the market and be successful. We create credible platforms for our clients to communicate their messaging to key stakeholders including government agencies, policy makers, health media, the medical & scientific key opinion leaders / influencers, etc,” added Dr Srivastava. Medical devices market in India offers promising futures for medical technology companies to grow significantly. The need is accessible, accurate and affordable solutions and hence ‘affordable' medical devices with robust outcomes in countries with diverse populations will have a bright future. ]]> <![CDATA[Glenmark launches affordable drug to treat kidney cancer in India]]> https://biospectrumindia.com/news/95/18111/glenmark-launches-affordable-drug-to-treat-kidney-cancer-in-india.html https://biospectrumindia.com/news/95/18111/glenmark-launches-affordable-drug-to-treat-kidney-cancer-in-india.html Tue, 16 Feb 2021 17:50:00 +0530 Glenmark Pharmaceuticals has launched SUTIB, the generic version of Sunitinib oral capsules to treat kidney cancer in India. The drug is launched at a MRP that is approximately 96 per cent lower than the MRP compared to the innovator brand, priced at Rs 7000 (50 mg), Rs 3600 (25 mg) and Rs 1840 (12.5 mg) per month. Sunitinib is also approved by the US Food and Drug Administration (US FDA).  Sunitinib is an oral multi-kinase inhibitor (MKI), works by blocking several enzymes that promote cell growth. It is useful for the treatment of certain patients with gastrointestinal stromal tumours and advanced renal cell carcinoma. It is also approved for patients with certain type of pancreatic neuroendocrine tumours.  Commenting on the launch, Alok Malik, Group Vice President & Business Head, India Formulations, Glenmark, said, “Oncology is an important focus area for Glenmark. We recognise that advanced kidney cancer is a complex disease and patients in India are faced with limited treatment options. Glenmark is committed to bringing targeted and effective medicines at an affordable cost to physicians and their patients.” ]]> <![CDATA[India gets first combined homeopathy & light therapy treatment for skin ailments]]> https://biospectrumindia.com/news/95/18107/india-gets-first-combined-homeopathy-light-therapy-treatment-for-skin-ailments.html https://biospectrumindia.com/news/95/18107/india-gets-first-combined-homeopathy-light-therapy-treatment-for-skin-ailments.html Tue, 16 Feb 2021 00:00:00 +0530 Through its latest offering, Dr Batra's brings Derma Heal, a first-of-its-kind, easy and pain-free skincare solution to its patients. Derma Heal - a revolutionary skincare treatment, combines the goodness of UVB light rays and homeopathy to treat skin diseases safely and naturally. Each Derma Heal session takes only 30 mins and is administered by trained therapists under the guidance of qualified homeopathic dermatologists. With a proven efficacy of more than 400 clinical research studies, this treatment method enhances skin treatment outcomes to give you better results in just five weeks. Derma Heal uses Narrowband UVB phototherapy. 'Narrowband' refers to a specific wavelength of ultraviolet (UV) radiation, ranging from 311 to 312 nm.  Commenting on the launch of Derma Heal, Dr Akshay Batra, Vice-Chairman and Managing Director, Dr Batra's Group of Companies and Fellow of Homeopathic Dermatology [Maharashtra University of Health Sciences (MUHS)] said, "Through Derma Heal, we aim to increase treatment results to up to 96 per cent as compared to 60 per cent in other conventional treatment methods.”   ]]> <![CDATA[XECH launches India’s first UV-C GI tech-powered stethoscope sterilizer ]]> https://biospectrumindia.com/news/95/18103/xech-launches-indias-first-uv-c-gi-tech-powered-stethoscope-sterilizer-.html https://biospectrumindia.com/news/95/18103/xech-launches-indias-first-uv-c-gi-tech-powered-stethoscope-sterilizer-.html Mon, 15 Feb 2021 16:15:00 +0530 XECH, India’s emerging innovator brand, has launched XECH STEROSTET – one-of-its-kind and India’s first stethoscope sterilizer which uses a special UV-C GI technology to effectively sterilize stethoscopes diaphragms of all sizes up to 99.9999 per cent. While necessity is the mother of inventions, Xech had begun its research to develop the SteroStet around two years ago. SteroStet is a device that effectively sterilizes a stethoscope diaphragm without using any chemicals or liquids and preserves the longevity of the expensive medical apparatus. The stethoscope is sterilized in merely five minutes while switching from one patient to another; using cutting-edge UV-C GI technology. It also comes with in-built intelligent sensors to ensure safe, smooth, hassle free & quick stethoscope sterilization possible. Speaking with determination Pranay Punjabi, Founder, Xech says, “We want to strengthen & support India’s healthcare system & provide every medical practitioner & healthcare worker with a safe & effective device while they keep us safe. At the same time, we wanted the device to be so convenient & easy to use that it becomes an integral part of their post-examination hygiene.” ]]> <![CDATA[PNB Vesper provides potential option to save hospitalised COVID-19 patients globally]]> https://biospectrumindia.com/news/95/18099/pnb-vesper-provides-potential-option-to-save-hospitalised-covid-19-patients-globally.html https://biospectrumindia.com/news/95/18099/pnb-vesper-provides-potential-option-to-save-hospitalised-covid-19-patients-globally.html Fri, 12 Feb 2021 19:00:00 +0530 PNB Vesper, a leading Kerala based life sciences company, has announced that it has successfully completed the phase 2 clinical trials of its proprietary drug PNB-001 (GPP-Baladol) on COVID-19 patients. The company had received approval from the Drug Controller General of India (DCGI) to conduct the Phase 2 Clinical trial of GPP-BALADOL in COVID-19 moderate patients with oxygen support in September 2020. The clinical trial was initiated in November 2020 at BJ Government Medical College and Sassoon General Hospital Pune, and Victoria Medical College and Research Institute, Bengaluru. The clinical trial report will now be submitted to DCGI on February 22, 2021. The trial was conducted on 40 patients. The clinical trial protocol was designed in-line with the solidarity trial conducted by WHO and other international clinical trials. In order to assess this effectiveness, the patients were divided into two groups and both groups were provided the standard of care described in the Clinical Management Protocol of the Ministry of Health & Family Welfare (MoHFW), in-line with WHO protocol. The other group, in addition to the standard of care, was given GPP-Baladol thrice a day at a dose of 100 milligrams. Speaking on the breakthrough innovation, PN Balaram, CEO, PNB Vesper Life Sciences Pvt Ltd said, “Considering the novel mechanism of action of the drug and the clinical trial outcome, GPP-Baladol can be a possible option to save the hospitalised patients all over the world.” Dr Eric Lattman, Vice President, PNB Vesper Life Sciences said, “The parameters evaluated in the clinical trial clearly indicate the potential of the drug in treating COVID-19 patients and the results indicate that GPP-Baladol can be a better therapeutic option for treating patients with severe lung lesions.”   ]]> <![CDATA[Molekule's Air Mini purifier listed on Amazon India portal]]> https://biospectrumindia.com/news/95/18095/molekules-air-mini-purifier-listed-on-amazon-india-portal.html https://biospectrumindia.com/news/95/18095/molekules-air-mini-purifier-listed-on-amazon-india-portal.html Fri, 12 Feb 2021 16:50:00 +0530 Molekule, a leader in reinventing air purification, announced the launch of Air Mini purifier in India through authorised resellers on Amazon.in. With this, Molekule introduces its award-winning patented Photo Electrochemical Oxidation (PECO) air purification technology to Indian consumers. Molekule’s Air Mini is currently available on Amazon.in at a retail price of Rs 37,999. Air Mini is designed for rooms up to up to 23 sq meters – ideal for apartments, bedrooms, and home offices. The purifier has five different fan speeds that can be adjusted as required. The energy consumption is between 18-53 watts, and the noise level varies between 36-62dBA, pending fan speed. It also uses a hybrid of Molekule’s Pre-Filter and PECO-Filter in a single filter. The proprietary PECO Technology is developed by the award-winning Dr D  Yogi Goswami, a Non-Resident Indian (NRI). PECO technology is capable of destroying a wide range of airborne pollutants compared to traditional air purifiers. The broad range of pollutants addressed by PECO includes the destruction of bacteria, viruses, mould, chemicals, and particulate matter in the air, among many other contaminants. Dr Yogi Goswami, Co-Founder, Chief Scientist, Molekule said, “Molekule technology works differently and is engineered to solve real problems. We encourage people to test and experience our technology, that not just filters out the air like most air purifiers available in the market, but also destroys harmful pollutants that are present in the air at a molecular level. India is an important market for us, and with our entry, we aim to bring the concept of cleaner air to the people of the country.”   ]]> <![CDATA[3M India to consolidate Pune manufacturing facilities into single unit]]> https://biospectrumindia.com/news/95/18093/3m-india-to-consolidate-pune-manufacturing-facilities-into-single-unit.html https://biospectrumindia.com/news/95/18093/3m-india-to-consolidate-pune-manufacturing-facilities-into-single-unit.html Fri, 12 Feb 2021 16:00:00 +0530 3M continually assesses business operations to ensure the company is focused on the right opportunities to support strategic priorities, drive growth, and meet customers’ evolving needs.  3M has made the decision to consolidate its Pune plants into a single facility at Ranjangaon, Pune and discontinue production at its Pimpri facility during the quarter Oct-Dec 2021. These actions will enable 3M to operate more efficiently, simplify supply chains, leverage scale, and enhance customer support. The company has taken care and consideration to offer employment to all workmen in Pimpri at the Ranjangaon plant. 3M will work closely with employees and all stakeholders for a smooth transition. ]]> <![CDATA[Shycocan helping curb spread of coronavirus indoors]]> https://biospectrumindia.com/news/95/18091/shycocan-helping-curb-spread-of-coronavirus-indoors.html https://biospectrumindia.com/news/95/18091/shycocan-helping-curb-spread-of-coronavirus-indoors.html Fri, 12 Feb 2021 00:00:00 +0530 A one-of-its-kind virus attenuation device developed by well-known Bengaluru scientist and inventor Dr Rajah Vijay Kumar is helping curb the spread of Coronavirus in indoor spaces, enabling schools, colleges, homes and businesses like hospitals, hotels, offices, restaurants, auditoriums, transportation, retail, and airports get back on track and serve their internal and external customers in a safe environment.   Manufactured by Bengaluru-based Shycocan Corporation, the device is called Shycocan, short for Scalene Hypercharge Corona Canon. It is effective in securing indoor spaces from the spread of not only the Coronavirus family which cause diseases like pneumonia, ARDS, SARS, MERS, COVID-19 and other Coronavirus induced diseases, but also the influenza family of viruses which trigger annual seasonal flu and serious epidemics such as swine flu and bird flu. Alok Sharma, Chief Executive Officer, Shycocan Corporation said, “We are also introducing this innovative made-in-India device in several other countries. It is already seeing a robust demand from institutional buyers both in India and abroad.”  Dr Rajah Vijay Kumar, Inventor, Shycocan, Global Chairman, Organisation De Scalene said, “Coronavirus-type outbreaks are occurring with faster intermittent frequencies. The Coronavirus family has got more infectious and deadly with successive mutations in the last 17 years, underscoring the importance of a device like Shycocan. The biggest challenge of this virus is its infectivity or virulence. Breaking the chain of infectivity requires focused work on indoor environments because they carry the highest risk of transmission.”  A single device when mounted has an effective coverage area of 1,000 sq ft (or 10,000 cubic feet). Multiple devices can be installed to cover a larger indoor space.   Image caption- Dr. Rajah Vijay Kumar, Inventor of Shycocan and the Global Chairman of Organisation De Scalene and Alok Sharma, Chief Executive Officer, Shycocan Corporation ]]> <![CDATA[Jubilant Biosys, Yale University collaborate for multiple small molecule research programmes]]> https://biospectrumindia.com/news/95/18084/jubilant-biosys-yale-university-collaboratefor-multiple-small-molecule-research-programmes.html https://biospectrumindia.com/news/95/18084/jubilant-biosys-yale-university-collaboratefor-multiple-small-molecule-research-programmes.html Thu, 11 Feb 2021 11:30:00 +0530 Jubilant Biosys and Yale University have announced a research collaboration for multiple small molecule research programmes. Under the scope of this partnership, Jubilant Biosys will provide research services to investigators at Yale University working on novel therapeutic targets. Areas of collaboration include medicinal chemistry, structural biology, in-vitro and in-vivo pharmacology among others. Commenting on this collaboration, Marcel Velterop, President Jubilant Biosys said "Yale is one of the top-ranked academic institutions in the US and we at Jubilant Biosys are delighted to be able to support scientific endeavours of investigators at Yale to pursue novel target ideas for unmet medical conditions. With our new discovery chemistry site scheduled to commence operations in 2021, we will further add to our capability a new infrastructure to service our partners." "Our CRO relationships are an integral component in our pursuit of helping Yale's scientific community transition their research towards commercialisation, and we are pleased to have Jubilant Biosys join our entrepreneurial ecosystem," said Bill Wiesler, Director, New Ventures and Blavatnik Fund for Innovation at Yale, Office of Cooperative Research. ]]> <![CDATA[Parexel, NeoGenomics to advance precision medicine in oncology clinical trials]]> https://biospectrumindia.com/news/95/18079/parexel-neogenomics-to-advance-precision-medicine-in-oncology-clinical-trials.html https://biospectrumindia.com/news/95/18079/parexel-neogenomics-to-advance-precision-medicine-in-oncology-clinical-trials.html Thu, 11 Feb 2021 00:00:00 +0530 Parexel, a leading provider of solutions to accelerate the development and delivery of innovative therapies to improve world health and NeoGenomics, Inc, a leading provider of cancer-focused genetic testing services and global oncology contract research services, have announced a strategic partnership to advance the application of precision medicine in oncology clinical trials by applying real-world genomics data to accelerate patient matching and optimise trial design, site selection, clinical development and translational research. The collaboration with NeoGenomics will enhance Parexel’s use of real-world data across various applications, including identifying and estimating prevalence of genomic mutations within respective populations, genomic patterning to stratify patients according to novel biomarkers, and use of de-identified patient data to precisely target patient populations. “Parexel’s partnership with NeoGenomics provides access to greater predictive modelling capabilities so that we can rapidly identify specific patients and connect them to clinical trials that provide them with the best potential for treatment, advance our understanding of their disease and identify the drug’s effects and potential benefits,” said Sy Pretorius, MD, President, Clinical Development and Chief Medical Officer, Parexel. “We are thrilled to collaborate with Parexel to provide our robust genomic and clinical database to help match cancer patients to clinical trials and therapies that are precisely targeted to their unique tumour types and genomic biomarkers,” said Douglas VanOort, Chairman and Chief Executive Officer, NeoGenomics. The companies are considering potential opportunities to expand the scope of the partnership, including lab services and biomarker capabilities.   ]]> <![CDATA[Wockhardt's COVID-19 vaccination contract with UK extends to Aug 2022]]> https://biospectrumindia.com/news/95/18083/wockhardts-covid-19-vaccination-contract-with-uk-extends-to-aug-2022.html https://biospectrumindia.com/news/95/18083/wockhardts-covid-19-vaccination-contract-with-uk-extends-to-aug-2022.html Wed, 10 Feb 2021 19:40:00 +0530 Wockhardt, the global pharmaceutical and biotechnology major, has announced that it has been awarded a six-month extension of its agreement with the UK Government to fill-finish COVID-19 vaccines.  This expands the original agreement from 18 to 24 months ie, until August 2022 and the manufacturing will continue to be undertaken at CP Pharmaceuticals, a subsidiary of Wockhardt based in Wrexham, North Wales. Liz Truss, UK International Trade Secretary on her visit to Mumbai as part of a drive to improve business links between the UK and India announced the extension, said, “This is a brilliant bit of news for the UK and people of Wrexham. It brings important investment to the local area, bringing jobs and security to the community as we battle this awful pandemic. Wockhardt’s investment shows the strength of our trading ties with India which is a further boost to our already-strong vaccine supply as we build back stronger from coronavirus.” Dr Habil Khorakiwala, Founder Chairman, Wockhardt Group emphasised, “We are happy to extend our collaboration with the UK Government to make vaccines available and the arrangement brings in a huge sense of purpose and pride, it upholds our ongoing global commitment to fight against an unprecedented pandemic.” ]]> <![CDATA[ FDA approves Lupin's Tavaborole Topical Solution]]> https://biospectrumindia.com/news/95/18075/-fda-approves-lupins-tavaborole-topical-solution.html https://biospectrumindia.com/news/95/18075/-fda-approves-lupins-tavaborole-topical-solution.html Tue, 09 Feb 2021 20:20:00 +0530 Global pharma major Lupin Limited announced that it has received approval for its Tavaborole Topical Solution, 5 per cent, from the United States Food and Drug Administration, to market a generic equivalent of Kerydin® Topical Solution, 5 per cent, of Anacor Pharmaceuticals, Inc. The product will be manufactured at Lupin’s facility in Pithampur, India. Tavaborole Topical Solution, 5 per cent, is an oxaborole antifungal indicated for the topical treatment of onychomycosis of the toenails due to Trichophyton rubrum or Trichophyton mentagrophytes. Tavaborole Topical Solution had estimated annual sales of $76 million in the US (IQVIA MAT December 2020). ]]> <![CDATA[Alembic Pharma to bring novel lymphoma drug for Indian cancer patients]]> https://biospectrumindia.com/news/95/18073/alembic-pharma-to-bring-novel-lymphoma-drug-for-indian-cancer-patients.html https://biospectrumindia.com/news/95/18073/alembic-pharma-to-bring-novel-lymphoma-drug-for-indian-cancer-patients.html Tue, 09 Feb 2021 17:00:00 +0530 Rhizen Pharmaceuticals, a clinical-stage oncology-focused biopharmaceutical company based in Switzerland, has announced that its novel next-generation PI3K-delta inhibitor, Umbralisib, which was licensed to TG Therapeutics, has secured US FDA accelerated approval for the treatment of: adult patients with relapsed or refractory marginal zone lymphoma (MZL) who have received at least one prior anti-CD20 based regimen, and adult patients with relapsed or refractory follicular lymphoma (FL) who have received at least three prior lines of systemic therapy. Accelerated approval was granted for these indications, under a priority review (MZL), based on the results of Phase 2 UNITY-NHL Trial (NCT02793583); in MZL, an ORR of 49 per cent with 16 per cent complete responses and in FL an ORR of 43 per cent with 3 per cent complete responses were achieved, respectively. Umralisib with the brand name UKONIQTM is a product invented by Rhizen Pharmaceuticals where Vadodara based Alembic Pharma has a 50% ownership. Umbralisib is a novel, next-generation, oral, once-daily, inhibitor of phosphoinositide 3 kinase (PI3K) delta and casein kinase 1 (CK1) epsilon and was discovered by Rhizen Pharma and subsequently licensed to TG Therapeutics at an IND stage (TGR 1202) in 2012. Swaroop Vakkalanka, President & CEO, Rhizen Pharmaceuticals said, “Umbralisib’s approval offers MZL & FL patients a new treatment option and is a huge validation of Rhizen’s drug discovery & development capabilities. We are keen to bring Umbralisib to Indian patients and we plan to initiate activities towards registration and approval there soon.” Pranav Amin, Chairman, Rhizen Pharmaceuticals & Managing Director, Alembic Pharmaceuticals Ltd said, “Umbralisib is the first discovery asset to come out of Rhizen’s R&D efforts and this approval heralds the promise of the rest of Rhizen’s deep pipeline and continuing efforts.” ]]> <![CDATA[Godrej Appliances' ultra-low temp freezer to ramp up global vaccine cold chain]]> https://biospectrumindia.com/news/95/18072/godrej-appliances-ultra-low-temp-freezer-to-ramp-up-global-vaccine-cold-chain.html https://biospectrumindia.com/news/95/18072/godrej-appliances-ultra-low-temp-freezer-to-ramp-up-global-vaccine-cold-chain.html Tue, 09 Feb 2021 16:25:00 +0530 Godrej Appliances has added state-of-the-art ultra-low temperature freezers to its portfolio, strengthening the vaccine cold chain further. These advanced medical freezers can preserve life-saving medical supplies including critical vaccines below -80°C and are aimed at boosting both Indian and global medical cold chain. The ultra low temperature freezers are a new addition to this portfolio and are particularly suited to mRNA-based vaccines which are being deployed in other countries currently. The mRNA-based COVID-19 vaccines are extremely temperature-sensitive as well and must be stored at very cold temperatures. The operating principle for the Godrej Ultra Low Temperature freezer is a cascading system having a PHE (plate heat exchanger) as a heat exchanger between the primary and the secondary system. This lowers the standing pressure of the secondary system leading to lowering of temperature. The current capacity for Ultra Low Temperature Freezers is 12,000 units per annum, which Godrej Appliances is working towards quickly ramping up to 30,000 units per annum, to meet the growing global demand.  Jamshyd Godrej, Chairman and Managing Director, Godrej & Boyce Manufacturing Company Ltd said, “Our latest offering of Ultra Low Temperature Freezers will help make India more ready for vaccines of the future as well. This endeavour also brings alive our ethos of Made in India for the world.” Kamal Nandi, Business Head and Executive Vice President, Godrej Appliances said, “With our newly launched range of advanced ultra-low temperature freezers, which can provide a temperature of below -80°C, India will also have the storage solutions readily available, for other COVID-19 vaccines being deployed across the world.”   ]]> <![CDATA[Medall unveils comprehensive pregnancy care package for three trimesters ]]> https://biospectrumindia.com/news/95/18064/medall-unveils-comprehensive-pregnancy-care-package-for-three-trimesters.html https://biospectrumindia.com/news/95/18064/medall-unveils-comprehensive-pregnancy-care-package-for-three-trimesters.html Mon, 08 Feb 2021 14:40:00 +0530 Chennai based Medall has announced a comprehensive pregnancy care package including all essential prenatal blood tests and scans for the three trimesters, as well as newborn baby screening and post-partum basic blood tests for the new mother. With both pathology and radiology testing capabilities and expertise under one single roof, Medall’s pregnancy package will make it convenient not only for pregnant women to avail the entire diagnostic services required during the nine months and immediately post, at Medall’s diagnostic centres closest to them but also for referring obstetricians outside of large hospitals.  In addition, Medall provides blood collection services at home, test reports that can be accessed on its app and website as well as parental counseling sessions every trimester, to help cope with anxiety and apprehensions of pregnancy. The package priced almost 40 per cent lower than the sum of the individual tests, which makes pregnancy care and testing more affordable as well.  Arjun Ananth, CEO, Medall, said “Pregnancy and childbirth is a very important milestone for expecting parents and their families. The baby’s health and well-being largely depend on the health of the mother and diagnostics in pregnancy form a critical role. While hospitals have their own pregnancy testing facilities, obstetricians who consult in clinics and other out-patient setups many a time do not have access to complete quality and accurate diagnostic services under a single roof. We are best positioned to address this gap with both radiology and pathology tests and expertise and testing centres across multiple locations.”  ]]> <![CDATA[AstraZeneca India's anti-diabetic drug receives approval for CKD treatment]]> https://biospectrumindia.com/news/95/18063/astrazeneca-indias-anti-diabetic-drug-receives-approval-for-ckd-treatment.html https://biospectrumindia.com/news/95/18063/astrazeneca-indias-anti-diabetic-drug-receives-approval-for-ckd-treatment.html Mon, 08 Feb 2021 13:40:00 +0530 AstraZeneca India (AstraZeneca Pharma India Limited), a leading science-led biopharmaceutical company, announced that they have received marketing authorisation for their anti-diabetic drug dapagliflozin, in India for the treatment of patients of chronic kidney disease (CKD) up to Stage III.  The receipt of this permission paves way for the launch of Dapagliflozin Tablets 10mg into a new disease area to nephrologists in India.  AstraZeneca’s dapagliflozin is the first medicine in SGLT-2i class to move into a new disease area by demonstrating efficacy and safety data for the treatment of patients with chronic kidney disease (CKD). The study results of dapagliflozin, showed significant benefits in reducing CKD progression in patients with and without type-2 diabetes. The DAPA-CKD study concluded globally on March 30, 2020 based on its effectiveness and safety. Dr Anil Kukreja, Vice President – Medical Affairs & Regulatory, AstraZeneca India said “With the approval of dapagliflozin for CKD in India, an already effective type 2 diabetes and select heart failure treatment, can now be used by nephrologists in the management of chronic kidney disease.” Dr Dinesh Khullar, National Lead Investigator, Dapa-CKD, India, said, “This will go a long way in the effective clinical management of diabetes and its complications in India. Its Approval by the regulatory bodies in India is a welcome move and will benefit CKD patients, both diabetics and non diabetics, including those where the disease has already progressed significantly.”  In May 2020, dapagliflozin was approved by US FDA to reduce the risk of CV death and hospitalisation for heart failure (hHF) in adults with heart failure (NYHA class II-IV) with reduced ejection fraction (HFrEF) with and without T2D.    ]]> <![CDATA[Axio Biosolutions receives CE Certification for next gen wound-care product MaxioCel]]> https://biospectrumindia.com/news/95/18056/axio-biosolutions-receives-ce-certification-for-next-gen-wound-care-product-maxiocel.html https://biospectrumindia.com/news/95/18056/axio-biosolutions-receives-ce-certification-for-next-gen-wound-care-product-maxiocel.html Fri, 05 Feb 2021 14:50:00 +0530 Axio Biosolutions, based in Bengaluru, has announced that it has received CE Certification from Europe for its next generation advanced wound-care product range, MaxioCel. The regulatory approval paves the path for Axio to tap into a fast growing $14 billion advanced wound-care market, globally.  This next-generation advanced wound-care dressing, MaxioCel is based on Bioactive Microfiber Gelling technology that accelerates healing through quicker granulation. It also provides comfort and has shown faster healing on chronic wounds, such as pressure ulcers, diabetic foot ulcers, venous leg ulcers, cavity wounds, skin abrasions, donor sites and post-operative surgical wounds during clinical studies. With more than 100,000 units shipped since its launch 18 months ago, MaxioCel has had a huge impact in Indian market. Dr Raghuram Sekhar, Consultant Vascular and Endovascular Surgeon, Kokilaben Dhirubhai Ambani Hospital, Mumbai who has been a long term user of Maxiocel affirms, “MaxioCel is a unique and advanced wound care dressing material. In different kind of cases that we used it, we witnessed rapid granulation and overall wound improvement while keeping the patients comfortable.” The CE approval will now help Axio with access to the second largest global market for advanced wound-care products. As part of its strategic plans, Axio will soon be launching MaxioCel in 15+ countries in Europe including reimbursement markets with multi-million revenues in this year itself. Responding to the CE certification and subsequent access to the European market, Leo Mavely, Founder and CEO, Axio Biosolutions said, “Since its launch, MaxioCel has made a huge impact on patient lives and the medical fraternity in India. We are excited to have the opportunity to extend this innovative and highly effective solution on a global level.” ]]> <![CDATA[Biocon to deliver advanced cancer therapies across 30 countries]]> https://biospectrumindia.com/news/95/18051/biocon-to-deliver-advanced-cancer-therapies-across-30-countries.html https://biospectrumindia.com/news/95/18051/biocon-to-deliver-advanced-cancer-therapies-across-30-countries.html Fri, 05 Feb 2021 00:00:00 +0530 Biocon Biologics Ltd, a fully integrated ‘pure play’ biosimilars company and a subsidiary of Biocon Ltd has signed an agreement with the Clinton Health Access Initiative (CHAI) to expand access to lifesaving cancer biosimilars in over 30 countries in Africa and Asia as a part of the Cancer Access Partnership (CAP). The partnership is a significant step in delivering advanced cancer therapies to patients who need them the most and ensuring equitable access to high-quality biosimilars in low- and middle-income countries (LMICs). Biocon Biologics’ strong R&D and manufacturing capabilities have enabled the Company to offer affordable biologics such as bTrastuzumab and bPegfilgrastim to cancer patients in developed markets like the European Union (EU) and the United States (US). Biocon Biologics will initially supply bTrastuzumab and bPegfilgrastim and will expand the arrangement to include other biosimilars. Kiran Mazumdar-Shaw, Executive Chairperson, Biocon Biologics said: “The collaboration with CHAI further strengthens our resolve to address the unmet patient needs in Asia and Africa for advanced cancer therapies through cost-effective alternatives to expensive reference biologics.” Dr Christiane Hamacher, CEO, Biocon Biologics said: “We are committed to reducing the high cost of cancer care for healthcare systems through our biosimilars and are pleased to address the needs of patients in Africa and Asia through the Cancer Access Partnership (CAP).” Dr Ian Barton, CEO, CHAI, stated: “Expanding the Cancer Access Partnership to include high-quality biologics from Biocon takes us another step closer to ensuring that cancer patients have access to the quality medications that they need at an affordable price, no matter where they live.” ]]> <![CDATA[Suniel Shetty becomes face of O2Cure air purification products in India ]]> https://biospectrumindia.com/news/95/18047/suniel-shetty-becomes-face-of-o2cure-air-purification-products-in-india-.html https://biospectrumindia.com/news/95/18047/suniel-shetty-becomes-face-of-o2cure-air-purification-products-in-india-.html Thu, 04 Feb 2021 16:05:00 +0530 Bollywood actor, entrepreneur & fitness enthusiast, Suniel Shetty enters into a strategic collaboration with O2Cure; an establishment under Zeco Aircon Ltd to introduce their air purification product line to the Indian markets. O2Cure provides RGF's (a US-based environmental design and manufacturing company) patented REME with  PHI-Cell® technology that has been successfully tested by CCMB-CSIR virology lab in India for reduction of SARS-CoV 2 by 97.48 per cent and by Innovation Bio-Analysis lab in the US for reduction of SARS-CoV-2 virus by 99 per cent from air and surfaces. Their products also prevent from other air contaminants like bacteria, viruses, germs, gases, particles, dust,  pollen, and other hazardous pathogens. Excited about the association with O2Cure; Shetty says “Unlike other air purifier brands in the market, these products are really helpful in not  only controlling airborne diseases but also neutralising the novel coronavirus (SARS-CoV-2) upto 99 per cent.” Elated about the collaboration with the Bollywood star; Kartik Singhal, Founder, O2Cure says “We are hopeful to push O2Cure not  just as a brand that can neutralise SARS-CoV-2 virus but as a necessity to your homes.” O2Cure carry’s forward over 3 decades of work in R&D by their parent company Zeco Aircon in air management systems and the use of advanced testing equipment’s enables them to meet the growing need for air filtration solutions for both corporate & individual consumers. The brand is also planning to introduce a new product line in the market that will focus on countering all types of air pollutants from indoor & outdoor air and surfaces. ]]> <![CDATA[TCG Lifesciences to offer CDMO services in US via subsidiary GreenChem Inc]]> https://biospectrumindia.com/news/95/18044/tcg-lifesciences-to-offer-cdmo-services-in-us-via-subsidiary-greenchem-inc.html https://biospectrumindia.com/news/95/18044/tcg-lifesciences-to-offer-cdmo-services-in-us-via-subsidiary-greenchem-inc.html Thu, 04 Feb 2021 12:40:00 +0530 Kolkata based TCG Lifesciences Pvt Ltd, a company controlled by New York-based The Chatterjee Group (TCG), has announced the expansion of its operations in the US with the establishment of TCG GreenChem Inc, a subsidiary of TCG Lifesciences Pvt Ltd, to provide contract development and manufacturing company (CDMO) services to global clients. TCG GreenChem, Inc, offers seamless CMC development services including process research & development and delivery of cGMP APIs. It aims at utilising its deep expertise in areas of automated catalysis/reaction screening, reaction optimisation, and continuous chemistry to support the needs of the big pharma and biotech industry. TCG GreenChem, Inc is developing novel, efficient and low-cost processes for selected COVID-19 virus-related medicines and other antiviral drugs using new technologies and process schemes under contract with research foundations/hospitals, US Government, and selected biotech companies. It is also engaged with developing several selected drugs with backward integration all the way to the starting materials within US shores. Swapan Bhattacharya, Managing Director, TCG Lifesciences Pvt Ltd commented, "TCG GreenChem has an exceptional management team, technological expertise and know-how, which is critical for the development of architecturally complex intermediates and APIs by utilising state-of-the-art synthetic organic chemistry.” Dr Chris H Senanayake, CEO and CSO, TCG GreenChem, Inc added, "Our mission is to create a ‘technology innovator’ CDMO, to partner with the pharmaceutical, biotechnology, and generic industries in delivering integrated, accelerated, and economical services utilising green sustainable technologies with a global footprint. Leveraging our knowledge of drug development and commercialisation, we want to be the drug development engine ‘accelerating molecules to medicines’ by advancing preclinical candidates into phase I and beyond, for our clients and partners.” ]]> <![CDATA[Enzene's anti-osteoporosis product Teriparatide receives DCGI nod]]> https://biospectrumindia.com/news/95/18043/enzenes-anti-osteoporosis-product-teriparatide-receives-dcgi-nod.html https://biospectrumindia.com/news/95/18043/enzenes-anti-osteoporosis-product-teriparatide-receives-dcgi-nod.html Thu, 04 Feb 2021 12:05:00 +0530 Pune based Enzene Biosciences Ltd has announced that it has obtained marketing authorisation (MA) from the Drug Controller General of India (DCGI) for teriparatide - bioactive part of human parathyroid hormone (PTH), an anabolic approach to the treatment of osteoporosis, compared to the anti-resorptive therapies such as bisphosphates and SERMs. According to company sources, the clinical trial conducted for Enzene's teriparatide is one of the most comprehensive trials for teriparatide in India which includes PK (Pharmacokinetics), immunogenecity as well as efficacy arm. The company sources also revealed that the approved product will be marketed through their holding company Alkem Laboratories Ltd and is also exploring other potential partnering opportunities. According to Dr Himanshu Gadgil, Whole Time Director, Enzene, "Our teriparatide will be launched in a fully compliant pen device. We are excited to bring to Indian patients the highest quality standard biosimilars underlining our commitment towards quality and innovation.” Commenting on the development, Sandeep Singh, Managing Director, Alkem Laboratories Ltd said, "I am pleased with the launch of teriparatide and look forward to many more launches from Enzene in the near future."  Alkem, through its subsidiary Enzene, has invested in biosimilars and would look to translate its success in small molecules in biosimilars as well. ]]> <![CDATA[SCHOTT global sales hits €2.24 billion, up by 2.2%]]> https://biospectrumindia.com/news/95/18035/schott-global-sales-hits-2-24-billion-up-by-2-2.html https://biospectrumindia.com/news/95/18035/schott-global-sales-hits-2-24-billion-up-by-2-2.html Wed, 03 Feb 2021 12:10:00 +0530 The international specialty glass group SCHOTT is continuing its positive development and is setting the course for a new phase of growth with its ongoing investment programme. Despite a generally weak economic environment due to the Coronavirus pandemic, SCHOTT continued to develop its key financial figures positively in the 2020 fiscal year or maintained them at the good level in its key markets including India. "Even in currently difficult economic times, we have stayed on course. We are therefore very satisfied with the past fiscal year," Dr Frank Heinricht, CEO, SCHOTT emphasised. "This is mainly thanks to our hard preparatory work in recent years. We have demonstrated stringent portfolio management and launched many innovations on the market. At the same time, we initiated the agile culture change in our organisation - and above all, invested with foresight. This has made us more robust as a company and paid off in this particular fiscal year." Global sales increased by 2.2 per cent to €2.24 billion. With an increase in sales of just under 6 per cent, SCHOTT was particularly successful in Asia. The foreign share of sales increased to 87 per cent including sales of €50 million coming from India. “Despite unprecedented challenges of last year, SCHOTT India has grown its sales, and expanded its production capacity and workforce – all while maintaining the best quality and safety standards. Contributing towards the climate neutral focus of our new global strategy, we have also achieved 100 per cent green electricity for our India plants through Energy Attribute Certificates (EACs),” shared Pawan Shukla, President & Managing Director, SCHOTT Glass India.   ]]> <![CDATA[US firm launches telemedicine platform to support respiratory health in India]]> https://biospectrumindia.com/news/95/18030/us-firm-launches-telemedicine-platform-to-support-respiratory-health-in-india.html https://biospectrumindia.com/news/95/18030/us-firm-launches-telemedicine-platform-to-support-respiratory-health-in-india.html Wed, 03 Feb 2021 00:00:00 +0530 Mateon Therapeutics, Inc, a US based developer of TGF-β therapeutics for oncology and infectious diseases, has announced that it has launched its artificial intelligence (AI) telemedicine platform for post marketing survey (PMS) to support the launch of its drug product, PulmoHealTM. The PMS module, with its previously announced AI mobile app, ArtiHealthTM, rounds out the company’s AI telemedicine solution. The combination of the drug and telemedicine targets patients for respiratory health, including COVID-19, in India. Initially the drug and device combination will only be available in India through Indian partner, Windlas, with the drug marketed under brand name PulmoHealTM. “Mateon's artificial intelligence (AI) telemedicine platform for post marketing survey (PMS), will provide large scale real world clinical data necessary for a systematic evaluation of PulmoHealTM in respiratory diseases such as COVID-19, COPD and asthma,” said Saran Saund, CBO, GM,  AI Division, Mateon. The PMS platform is meant to collect large amount of real-world evidence for safety and efficacy that would be instrumental in disease expansion of PulmoHealTM. “We are thrilled to launch PulmoHealTM for respiratory patients based on successful outcome of ARTI-19 interim data,” said Hitesh Windlas, MD, Windlas.  The interim report of 60 patients of the ARTI-19 study found PulmoHealTM to be significantly effective by more than doubling the recovery rate of COVID-19 patients. Mike Potts, VP, Artificial Intelligence (AI), Mateon, commented, "I am excited with the launch of our telemedicine PMS platform to support PulmoHealTM. We built this telemedicine platform to support future clinical studies and not for PulmoHeal alone.” Amit Shah, CFO, Mateon, commented, "With our continued drive to remove inefficiencies from the drug development and clinical trials processes, the launch of the PMS telemedicine module sets the stage for continual improvement of drug development and clinical trials.” ]]> <![CDATA[Pregna launches cryotherapy device CryoPop]]> https://biospectrumindia.com/news/95/18027/pregna-launches-cryotherapy-device-cryopop.html https://biospectrumindia.com/news/95/18027/pregna-launches-cryotherapy-device-cryopop.html Tue, 02 Feb 2021 15:50:00 +0530 Pregna International Ltd has furthered its status as a leading women's healthcare organisation with the launch of its ground-breaking cryotherapy device, CryoPop.  The ingenious device was developed by Jhpiego with the objective of making the treatment of cervical pre-cancerous lesions accessible to all. Pregna is the exclusive global commercialising partner for the device. Jhpiego’s role in maternal and child health has expanded dramatically over the years, increasing its emphasis on nurses and midwives as primary care providers. "The good news is that thanks to advancements in screening and diagnosis, cervical cancer is not only preventable, but also one of the most successfully treatable forms of cancer,” said Manmohan Taparia, Marketing Manager, Pregna. Ajit Raje, Vice President, Pregna noted, "CryoPop will play a vital role enabling healthcare professions at all levels to effectively treat the disease. The first step is to create awareness and educate the masses about the disease.” Mukul Taparia, Managing Director, Pregna observed, "Cryotherapy is one of the most effective methods to treat cervical lesions, yet the infrastructure required in traditional equipments has hampered its large scale adoption. Let us go out and save lives.” Majority of the traditional cryotherapy devices use nitrous oxide as the cryogen, which is expensive and requires proper scavenging. Moreover, the large and heavy gas cylinders must be tethered to the cryotherapy device during use. CryoPop offers a more mobile, cost-effective and robust alternative to reach women even in low-resource settings. ]]> <![CDATA[Lupin, Phil Inc partner to deliver solutions for patients on Solosec®]]> https://biospectrumindia.com/news/95/18026/lupin-phil-inc-partner-to-deliver-solutions-for-patients-on-solosec.html https://biospectrumindia.com/news/95/18026/lupin-phil-inc-partner-to-deliver-solutions-for-patients-on-solosec.html Tue, 02 Feb 2021 13:05:00 +0530 Lupin Pharmaceuticals, Inc, a global pharmaceutical company, has announced a partnership with Phil, Inc, which helps deliver cost-effective next-generation access solutions for patients who are prescribed Solosec® (secnidazole) 2g oral granules for the treatment of bacterial vaginosis (BV) in adult women. Solosec® is the only single 2g oral dose therapy for the most common vaginal infection in the US among adult women. This treatment is designed to deliver a full course of therapy in just one packet. "With the addition of Solosec® to the Phil platform, we are able to provide a convenient channel for physicians to prescribe Solosec® and enhance the patient experience," said Jon Stelzmiller, President - Specialty, Lupin Pharmaceuticals, Inc.  "Phil offers a systemic solution for a systemic problem," Deepak Thomas, Founder, and CEO, Phil, Inc, said in a statement. "Because the underlying challenges in this space are experienced not just at the pharmacy but may extend to other stakeholders including prescribers and manufacturers, Phil aims to address these issues in their entirety.” ]]> <![CDATA[Bharat Biotech plans to take COVAXIN to US market]]> https://biospectrumindia.com/news/95/18033/bharat-biotech-plans-to-take-covaxin-to-us-market.html https://biospectrumindia.com/news/95/18033/bharat-biotech-plans-to-take-covaxin-to-us-market.html Tue, 02 Feb 2021 00:00:00 +0530 Ocugen, Inc., a US based biopharmaceutical company focused on discovering, developing, and commercializing gene therapies to cure blindness diseases and developing a vaccine to fight COVID-19, and Bharat Biotech, a global leader in vaccine innovation, have announced they have entered into a definitive agreement to co-develop, supply, and commercialize Bharat Biotech’s COVAXIN™️, an advanced stage whole-virion inactivated COVID-19 vaccine candidate, for the United States market.Under the terms of the agreement, Ocugen will have US rights to the vaccine candidate and will be responsible for clinical development, regulatory approval (including EUA) and commercialization for the US market. Bharat Biotech will supply initial doses to be used in the US upon Ocugen’s receipt of an EUA. In addition, Bharat Biotech will support the technology transfer for manufacturing in the US. In consideration for the exclusive license to the US market, Ocugen will share the profits from the sale of COVAXIN™️ in the US market with Bharat Biotech, with Ocugen retaining 45% of the profits.The collaboration will leverage the vaccine expertise of Ocugen’s leadership team. In preparation for the development of COVAXIN™️ in the US, Ocugen’s Vaccine Scientific Advisory Board and Ocugen management have initiated discussions with the U.S. Food & Drug Administration (FDA) and the Biomedical Advanced Research and Development Authority (BARDA) to develop a regulatory path to EUA and, eventually, biologics license application (BLA) approval in the US market for COVAXIN™️. Ocugen is also in active discussions with manufacturers in the US to produce a significant number of doses of COVAXIN™️ to support its US immunization program. “The COVID-19 pandemic has affected humanity at large. As a company determined to protect global public health, it has always been important for us to develop vaccines for a global cause. Our goal for all vaccines developed at Bharat Biotech is to provide global access. COVAXIN™️ has generated excellent safety data with robust immune responses to multiple viral proteins that persist. With the recent progression of COVAXIN use under EUA in India, I am confident that we will be able to work with Ocugen to develop a plan to bring COVAXIN to the US market.,” said Dr. Krishna Ella, Chairman & Managing Director of Bharat Biotech. ]]> <![CDATA[BreatheEasy introduces self – sanitising KARBON face mask]]> https://biospectrumindia.com/news/95/18016/breatheeasy-introduces-self-sanitising-karbon-face-mask.html https://biospectrumindia.com/news/95/18016/breatheeasy-introduces-self-sanitising-karbon-face-mask.html Fri, 29 Jan 2021 19:20:00 +0530 New Delhi based BreatheEasy Consultants has introduced the unique , self – sanitising, comfortable, Nelson labs certified KARBON face mask, which ensures that we are protected from the deadly virus with its innovative 3-layer protection. Designed in India using premium quality material sourced from Europe and the US, the fabric is NIOSH (The National Institute for Occupational Safety and Health) tested. Made from biotechnology-based patented fabric, it has been tested for wearing in different conditions; and is an ideal safety gear against airborne pathogens and the deadly virus. “The KARBON face mask’s inner layer comprises of high-grade imported yarn that has antimicrobial properties to ensure effective neutralisation of viruses and pathogens on contact. This makes sure that it cuts down on the chance of virus infection at the source level and helps to reduce the spread of infection,” says Barun Aggarwal, CEO, BreatheEasy. The first layer reduces the virus effect on contact while the double-knit second layer protects one from microbial infection and cuts down on the chance of secondary infection. The third (inner) layer, made of superior grade bio-yarn, maximises protection (more than 95 per cent, better than N95 masks) against airborne pollutants for a long duration. “The KARBON face mask is a sustainable, comprehensive and economic choice against airborne infections. Although the N95 is a popular choice since it protects against airborne infection and the deadly virus, however, it needs to be discarded after a few hours of usage and is not reusable,” adds Aggarwal.   ]]> <![CDATA[Envirotainer sets up full-service station in Bengaluru for vaccine producers]]> https://biospectrumindia.com/news/95/18011/envirotainer-sets-up-full-service-station-in-bengaluru-for-vaccine-producers.html https://biospectrumindia.com/news/95/18011/envirotainer-sets-up-full-service-station-in-bengaluru-for-vaccine-producers.html Fri, 29 Jan 2021 12:20:00 +0530 Envirotainer, the global market leader and by far the largest provider of secure cold chain solutions for air transport of pharmaceuticals, have announced that they are expanding their global station network by adding a third station in India, this time in the city of Bengaluru.  Bengaluru becomes the 43rd station in the Envirotainer network to carry the flagship RAP e2 which is currently commonly used for the temperature-sensitive COVID-19 vaccine shipments across the world. The new station will be operational from February 1, 2021 and will, in addition to the RAP e2, also carry the smaller RKN e1, heating and cooling container. The RAP e2 is the most environmentally friendly temperature-controlled air cargo container available in the market. Delivering pharmaceuticals using the Envirotainer RAP e2 emits 0.9kg CO2e per vial shipped. "By opening a full-service station in the pharmaceutical hub of Bangalore, India, we want to help our Indian vaccine producing customers by providing easier and faster access to state-of-the-art cold-chain solutions," explains Suat Toh, Head of Sales APAC, Envirotainer.” "We are investing heavily across the world, both in our service network and also in our container fleet, to support the ongoing and upcoming COVID-19 vaccine(s) shipments," explains Eddy Cojulun, Chief Sales Officer, Envirotainer.   ]]> <![CDATA[Qural unveils new features to address COVID-19 vaccination queries]]> https://biospectrumindia.com/news/95/18004/qural-unveils-new-features-to-address-covid-19-vaccination-queries.html https://biospectrumindia.com/news/95/18004/qural-unveils-new-features-to-address-covid-19-vaccination-queries.html Thu, 28 Jan 2021 14:45:00 +0530 Qural, a smart mobile healthcare app with a simple dashboard, UI and UX features, that enables users to take control of their health information, has announced the launch of two new mobile features, that will address all the doubts and questions that are in the minds of people about COVID-19 vaccination. The two new features ‘My Vaccine’ and ‘Vaccine Monitor’ are free to use and will help the users find answers to several questions that are related to vaccination. The developer of Qural App based in Hyderabad, is a subsidiary of the US headquartered Saince Inc. Qural was designed keeping in mind the need to provide access to affordable healthcare to people across the country. Raghu Vir, Founder and CEO, Saince Inc & Qural App, reveals, “My Vaccine & Vaccine Monitor are built using our proprietary technology. While Qural’s My Vaccine is developed by taking into consideration the priorities of population segments decided by the Government of India, like production capacity of the vaccines, the number and spacing of shots etc and to get an idea of when will one get his or her vaccination, Vaccine Monitor, help users to keep track of the side effects of the vaccine after they receive their first and the second vaccine doses. The new feature also proactively sends alerts and reminders to users to keep track of their vaccination.” He added, “We have done extensive scientific research and created an algorithm based on current guidelines from the Government of India, made it flexible, even if regulators change the rules in the future.” Hyderabad based Saince HealthTech's Qural App launched earlier, is a free-to-subscribe, healthcare mobile app to aid patients, physicians, pharmacies, and labs interconnect with each other.   Image caption- Raghu Vir, Founder and CEO, Saince Inc & Qural App ]]> <![CDATA[Cipla installs 30 MW solar group captive project in Tuljapur, Maharashtra]]> https://biospectrumindia.com/news/95/17998/cipla-installs-30-mw-solar-group-captive-project-in-tuljapur-maharashtra.html https://biospectrumindia.com/news/95/17998/cipla-installs-30-mw-solar-group-captive-project-in-tuljapur-maharashtra.html Wed, 27 Jan 2021 16:45:00 +0530 Cipla Limited announced that it has set up a 30 MW solar group captive project in Tuljapur, Maharashtra. Spread across 115 acres, the solar project has been commissioned in partnership with AMP Energy India, and is one of the largest solar open access projects in the state set up by a corporate. This is in line with the company’s Environmental, Social and Governance (ESG) initiatives aimed at developing a holistic sustainability road map for the future. By 2025, Cipla plans to achieve carbon and water neutrality, zero-waste to landfill, anti-microbial resistance stewardship and green chemistry. The project will support the company’s green energy requirements for its manufacturing units at Kurkumbh and Patalganga in Maharashtra. It will also help the Company avoid carbon dioxide emissions by as much as 35,000 tonnes of carbon dioxide equivalent (tCO2e) annually over its project life of 25 years. Speaking on the occasion, Kedar Upadhye, President and Global CFO, Cipla, said, “This project is testament to our relentless commitment to use cleaner and renewable sources of energy.” Geena Malhotra, President and Global Head – Manufacturing Operations, Cipla, commented, “The project aims to reduce our environmental footprint and create a positive social impact. We endeavour to continue growing the share of renewable energy across our sites with an aim to contribute to India’s agenda of increasing energy generation from non-fossil fuel sources to 40% by 2030.” ]]> <![CDATA[Piramal Pharma provides sterile fill/finish services to Canadian firm]]> https://biospectrumindia.com/news/95/17995/piramal-pharma-provides-sterile-fill-finish-services-to-canadian-firm.html https://biospectrumindia.com/news/95/17995/piramal-pharma-provides-sterile-fill-finish-services-to-canadian-firm.html Wed, 27 Jan 2021 12:05:00 +0530 Piramal Pharma Limited's Pharma Solutions business, a leading contract development and manufacturing organisation (CDMO), has announced that it is providing Canada based Theratechnologies Inc with GMP manufacturing of sterile fill/finish drug product to support their developmental product as it enters into a first-in-human clinical study. The clinical material is being produced at the Piramal Pharma Solutions (PPS) manufacturing site in Lexington, Kentucky, which is recognised globally for its expertise in sterile fill/finish services. It will be used in a Phase I trial for TH1902, Theratechnologies' lead peptide-drug conjugate (PDC) (docetaxel conjugate). The Phase I trial design includes a dose-escalation study to evaluate the safety, pharmacokinetics, maximum tolerated dose (MTD) and preliminary anti-tumour activity of TH1902 administered once every three weeks in patients with advanced solid tumours refractory to available anti-cancer therapies. According to Peter DeYoung, Chief Executive Officer, Piramal Pharma Solutions, "Our Lexington team went the extra mile to provide solutions to ensure timely formulation development and production of the material. It's yet another example of how we are focused on working with our customers to reduce the burden of disease on patients.” ]]> <![CDATA[GSK, PATH, Bharat Biotech join hands for novel malaria vaccine ]]> https://biospectrumindia.com/news/95/18002/gsk-path-bharat-biotech-join-hands-for-novel-malaria-vaccine-.html https://biospectrumindia.com/news/95/18002/gsk-path-bharat-biotech-join-hands-for-novel-malaria-vaccine-.html Wed, 27 Jan 2021 00:00:00 +0530 GSK, PATH, and Bharat Biotech (BBIL) have announced the signing of a product transfer agreement for the malaria vaccine, RTS,S/AS01E 1. The agreement includes the transfer of manufacturing of the RTS,S antigen part of the vaccine and the grant of a license on all rights pertaining to the RTS,S/AS01 malaria vaccine to BBIL. GSK will retain the production of the adjuvant of the vaccine (AS01E) and will supply it to BBIL. The RTS,S/AS01E malaria vaccine, developed by GSK for more than 30 years, and in partnership with PATH since 2001, is currently being piloted in regions of Ghana, Kenya, and Malawi under the Malaria Vaccine Implementation Programme (MVIP). Ministries of health are leading the implementation of the vaccine, which is being given to young children through the three countries’ routine immunisation programmes, with WHO providing technical and scientific leadership, playing a coordinating role, and working in collaboration with GSK, PATH, and a range of other partners. RTS,S/AS01E is the first, and to date, the only malaria vaccine to have received a positive review by regulatory authorities (positive scientific opinion from the European Medicines Agency and approval by the regulatory authorities of Ghana, Kenya, and Malawi for use in the MVIP). The first dose of the vaccine has reached more than 500,000 children since the pilots were initiated by ministries of health in the three participating countries in 2019. This agreement with BBIL is the result of efforts by GSK, PATH, and WHO to help ensure long-term sustainable vaccine supply, in the event of a WHO policy recommendation for broader use and a commitment of sustained funding. This builds on existing GSK commitments to donate up to 10 million RTS,S/AS01E doses for use in the pilot, and to supply up to 15 million doses annually until 2028 if the product is recommended for wider use by WHO. It is expected that by 2029, at the latest, BBIL will be the sole supplier of the vaccine, with GSK supplying the adjuvant AS01E to them. ]]> <![CDATA[Lupin receives FDA approval for Sevelamer Carbonate tabs]]> https://biospectrumindia.com/news/95/17990/lupin-receives-fda-approval-for-sevelamer-carbonatetabs.html https://biospectrumindia.com/news/95/17990/lupin-receives-fda-approval-for-sevelamer-carbonatetabs.html Mon, 25 Jan 2021 18:40:00 +0530 Lupin Limited, a global pharmaceutical company, announced that it has received approval for its Sevelamer Carbonate tablets, 800 mg, from the United States Food and Drug Administration, to market a generic equivalent of Renvela® tablets, 800 mg, of Genzyme Corporation. Sevelamer Carbonate tablets, 800 mg, are indicated for the control of serum phosphorus in adults and children 6 years of age and older with chronic kidney disease on dialysis. Sevelamer Carbonate tablets (RLD: Renvela®) had estimated annual sales of $348 million in thUS (IQVIA MAT September 2020).     ]]> <![CDATA[Zydus announces Ph 2(b) results of Desidustat in COVID-19 patients in Mexico]]> https://biospectrumindia.com/news/95/17989/zydus-announces-ph-2b-results-of-desidustat-in-covid-19-patients-in-mexico.html https://biospectrumindia.com/news/95/17989/zydus-announces-ph-2b-results-of-desidustat-in-covid-19-patients-in-mexico.html Mon, 25 Jan 2021 18:35:00 +0530 Zydus announced that it has received positive results from Phase 2(b) studies of Desidustat in COVID-19 patients conducted at Mexico. Patients infected with COVID-19 have been reportedly  displayed signs of ‘Hypoxia’ leading to organ failure and death despite the use of antivirals, anti-inflammatory drugs or ventilators.  Speaking on the development, Pankaj R Patel, Chairman, Zydus Group said, “We are excited to report for the first time, this encouraging data of our novel HIF-PH inhibitor, Desidustat, showing the potential to help prevent acute respiratory distress syndrome (ARDS) in COVID-19 patients.”  The Phase 2(b) results of this study revealed that Desidustat treatment led to increased red blood cell production and improved oxygen delivery to tissues. None of the hospitalised patients required mechanical ventilator in the Desidustat arm, while 25% of COVID-19 patients on the standard of care arm required mechanical ventilation. In this Phase 2(b) clinical study, the standard of care reported the mean increase in IL-6, while the Desidustat arm remained stabilised. Detailed reports will be published in a scientific journal.  Zydus had conducted the Phase 2b, multi-centre, 0pen-label, randomised, comparator- controlled study to evaluate the efficacy and safety of Desidustat tablet for the management of COVID-19 patients. Clinical and regulatory development of Desidustat in COVID-19 was executed in Mexico by Avant Santé Research Center SA de CV, a leading Contract Research Organisation (CRO) headquartered in Monterrey, Mexico. Zydus had initiated two Phase III trials of Desidustat. The DREAM-ND Phase III trial is being conducted in 588 CKD patients not-on-dialysis. The DREAM-D Phase III trial is being conducted in 392 CKD patients on dialysis. Desidustat is also being studied in cancer chemotherapy induced anaemia. ]]> <![CDATA[Biocon Ltd posts Q3FY21 net profit of Rs 169 Cr ]]> https://biospectrumindia.com/news/95/17980/biocon-ltd-posts-q3fy21-net-profit-of-rs-169-cr-.html https://biospectrumindia.com/news/95/17980/biocon-ltd-posts-q3fy21-net-profit-of-rs-169-cr-.html Fri, 22 Jan 2021 16:05:00 +0530 Biocon Ltd, an innovation-led global biopharmaceuticals company, has announced its consolidated financial results for the fiscal third quarter ended December 31, 2020. Commenting on the results, Kiran Mazumdar-Shaw, Executive Chairperson, Biocon, said, ”Consolidated revenue for Q3FY21 increased 7 per cent year on year to Rs 1,879 crore driven by 13 per cent growth in Research Services, and 11 per cent in Biosimilar business segments. EBITDA for the quarter stood at Rs 427 crore and net profit was at Rs 169 crore. Our Core EBITDA margins stood at 31 per cent. "The two recent investments of $225 million in Biocon Biologics by Goldman Sachs and ADQ endorse the value creation of our biosimilars business. These investments augur well for our business and will enable us to invest in expanding our research and manufacturing capacities across segments. The recent launch of Tacrolimus capsules in the US, as well as approvals in Most of the World (MoW) markets for Insulin Aspart, Bevacizumab and Trastuzumab biosimilars will also pave the way for expanding our business in future." ]]> <![CDATA[Alembic Pharmaceuticals receives FDA approval for Midodrine Hydrochloride tablets]]> https://biospectrumindia.com/news/95/17978/alembic-pharmaceuticals-receives-fda-approval-for-midodrine-hydrochloride-tablets.html https://biospectrumindia.com/news/95/17978/alembic-pharmaceuticals-receives-fda-approval-for-midodrine-hydrochloride-tablets.html Fri, 22 Jan 2021 14:15:00 +0530 Alembic Pharmaceuticals Limited announced it has received approval from the US Food & Drug Administration (US FDA) for its abbreviated new drug application (ANDA) Midodrine Hydrochloride tablets USP, 2.5 mg, 5 mg, and 10 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), ProAmatine tablets, 2.5 mg, 5 mg, and 10 mg, of Takeda Pharmaceuticals US, Inc. Midodrine hydrochloride tablets are indicated for the treatment of symptomatic orthostatic hypotension (OH).  Midodrine Hydrochloride tablets USP 2.5 mg, 5 mg, and 10 mg have an estimated market size of $60 million for twelve months ending September 2020 according to IQVIA. ]]> <![CDATA[Cure.fit acquires Onyx eyeing international markets]]> https://biospectrumindia.com/news/95/17977/cure-fit-acquires-onyx-eyeing-international-markets.html https://biospectrumindia.com/news/95/17977/cure-fit-acquires-onyx-eyeing-international-markets.html Fri, 22 Jan 2021 13:55:00 +0530 With a view to bolster its digital offerings in India and abroad, Cure.fit, India's largest health & fitness company, has acquired Onyx, a California-based fitness company that is building the world's smartest digital training experience. Cure.fit's acquisition of Onyx is a step towards improving its computer vision technology for its at-home fitness product and expanding its international business. Cure.fit is India's largest and most-funded health-tech company. Cure.fit recently launched in the US with its energy-meter tech wherein the phone camera tracks users' movements as they try to follow guided content from trainers. Users can track their improvement, compete with their friends, post selfies, and follow their favourite trainers. Commenting on the acquisition, Mukesh Bansal, Co-Founder, Cure.fit, said: "Onyx will accelerate our efforts towards building a hardware agnostic AI-led platform that offers guided content on physical & mental wellness and nutrition all at the same place.” Shamik Sharma, Head of Technology, Cure.fit, stated, "With this tech, our digital product will be very similar to attending a group class at boutique studio or a personal training session in the gym. While talking about the acquisition, Asaf Avidan Antonir, Co-Founder, Onyx, said, "We are excited to be joining Cure.fit to contribute to this shared mission, and together bring incredible digital fitness experiences to a global audience even faster.” ]]> <![CDATA[The Lancet publishes Ph I trial studies of Covaxin]]> https://biospectrumindia.com/news/95/17982/the-lancet-publishes-ph-i-trial-studies-of-covaxin.html https://biospectrumindia.com/news/95/17982/the-lancet-publishes-ph-i-trial-studies-of-covaxin.html Fri, 22 Jan 2021 00:00:00 +0530 Following the speculations regarding the efficacy of its COVID-19 vaccine, Hyderabad based Bharat Biotech has recently announced the publication of the phase 1 clinical trials of Covaxin in the most prestigious medical journal of The Lancet Infectious diseases. This is the first clinical trial publication on a COVID-19 vaccine from India. The study reveals that the vaccine was well tolerated in all dose groups with no vaccine-related serious adverse events. The most common adverse event was pain at the injection site, followed by headache, fatigue, and fever. The overall incidence of solicited local and systemic adverse events in this study was 14–21% in all vaccine-treated groups, which is noticeably lower than the rates for other SARS-CoV-2 vaccine platform candidates and similar to the rates for other inactivated SARS-CoV-2 vaccine candidates. One serious adverse event (positive for SARS-CoV-2 by a nucleic acid test) in an individual was not related to vaccination. Because the event occurred in the 5 days after vaccination, the development of a protective immune response was not likely. "We continue in this journey of bringing you work that is made in India on par with international standards", says Suchitra Ella, Joint Managing Director, Bharat Biotech, Hyderabad. ]]> <![CDATA[Fire breaks at Manjri plant of Serum Institute ]]> https://biospectrumindia.com/news/95/17975/fire-breaks-at-manjri-plant-of-serum-institute-.html https://biospectrumindia.com/news/95/17975/fire-breaks-at-manjri-plant-of-serum-institute-.html Thu, 21 Jan 2021 00:00:00 +0530 A major fire has broken out on the fourth and fifth floor of the Special Economic Zone (SEZ 3) building in the Serum Institute plant at Manjri in Pune. Although the cause of the fire is not certain, the Manjri facility is apparently the one where Covishield vaccine is being made. However, reports have revealed that this accident would not affect the production of the coronavirus vaccine as the fire broke out in a facility away from the place where the vaccines are manufactured. “We have just received some distressing updates; upon further investigation we have learnt that there has unfortunately been some loss of life at the incident. We are deeply saddened and offer our deepest condolences to the family members of the departed.”, tweeted Adar Poonawalla, Chief Executive Officer, Serum Institute of India, Pune, while expressing condolences after five people died due to the fire. Back in 2019, the company had announced an investment of over Rs 3000 crore for the Manjri plant that operates with state-of-the-art equipment and facilities for an enhanced production quantity.    ]]> <![CDATA[CPhI & P-MEC China 2020 poised to stimulate renewed growth across pharma supply chain]]> https://biospectrumindia.com/news/95/17968/cphi-p-mec-china-2020-poised-to-stimulate-renewed-growth-across-pharma-supply-chain.html https://biospectrumindia.com/news/95/17968/cphi-p-mec-china-2020-poised-to-stimulate-renewed-growth-across-pharma-supply-chain.html Wed, 20 Jan 2021 20:00:00 +0530 The recently hosted CPhI & P-MEC China 2020 – organised by Informa Markets and CCCMHPIE and co-organised by Shanghai Sinoexpo Informa Markets International Exhibition Co, Ltd – attracted a remarkable 46,157 visits of professional pharma visitors, including 5,105 international attendees taking part online. The hybrid event has helped stimulate renewed growth and partnerships across the pharma supply chain, with the pharma industry looking well positioned for 2021. The ingredients, machinery and manufacturing sectors reported particularly robust attendance – with full implementation of the Marketing Authorisation Holder (MAH) system, coupled with priority review pathways from the NMPA (National Medical Products Administration) driving much new demand. In fact, 2,958 companies from the pharma supply chain attended – including Pfizer, Sanofi, Capsugel, Dupont, Merck, BASF, Fosun Pharma, Hengrui Medicine, Yangtze River Pharmaceutical and Fette. Finally, to celebrate the 20th anniversary of CPhI China, the organising committee awarded a ‘CPhI China 20th Anniversary Founding Exhibitor Award’ and ‘P-MEC China 15th Anniversary Founding Exhibitor Award’ on the opening day at the CPhI China 20th anniversary reception. For international online attendees, the event teamed up with PharmaSources.com to launch the Virtual Expo Connect (VEC), which ran for a full month in December and connected pharma in China with overseas customers. “2021 promises to be a celebration of the pharma industry with vaccine distribution now underway and we look forward to helping the industry meet both online and in person so it can continue its work in discovering and delivering vital therapies to patients,” commented Laura Murina, Brand Manager, Informa. CPhI & P-MEC China 2021 will return to SNIEC (from December 16-18, 2021) with a comprehensive online and offline offering – providing access to vital connections in person and through enhanced digital pharma platforms. ]]> <![CDATA[CII recognises Merck with ‘Overall Excellence' at SCALE Awards 2020]]> https://biospectrumindia.com/news/95/17954/cii-recognises-merckwith-overall-excellence-at-scale-awards-2020.html https://biospectrumindia.com/news/95/17954/cii-recognises-merckwith-overall-excellence-at-scale-awards-2020.html Tue, 19 Jan 2021 00:00:00 +0530 Merck has won the prestigious ‘Overall Excellence’ award by the Confederation of Indian Industry (CII)- Institute of Logistics SCALE Awards 2020. These awards were instituted by the CII to honour companies focused on growth through innovation and optimisation. This award recognises the work in sustainability, significant technical skills upgrade and production excellence related to the delivery of scale-up of products used by manufacturers of COVID-19 vaccines. The Merck team was chosen among a long list of other multi-national companies, big pharmaceutical and chemical companies in India. Merck’s sustainability improvements implemented in 2020 resulted in around two lakh litres of water saved as well as improved distribution and use of treated water on site. The company plans to increase its solar energy use and implement additional energy methods in the coming years. The award also recognised the company’s India research and development team for manufacturing a key compound used in COVID-19 RT-PCR testing within just seven weeks. The team was able to secure supplies during a country lockdown while addressing stabilisation and scalability of the process. “This recognition is the result of the collaboration and effective implementation between the different teams who have taken up responsibility of high-quality delivery in these challenging times,” said Prabhat Verma, Head, Integrated Supply Chain Operations, Merck India.    ]]> <![CDATA[ChemTECH BioPharma World.IE Conference to cover nuances of biopharmaceuticals]]> https://biospectrumindia.com/news/95/17961/chemtech-biopharma-world-ie-conference-to-cover-nuances-of-biopharmaceuticals.html https://biospectrumindia.com/news/95/17961/chemtech-biopharma-world-ie-conference-to-cover-nuances-of-biopharmaceuticals.html Tue, 19 Jan 2021 00:00:00 +0530 The ChemTECH BioPharma World.IE Conference is set to explore and address the opportunity & the challenge through ChemTECH Biopharma World.IE Conference - Bio-Pharmaceuticals: A Next Big Opportunity, to be held from Feb 24 to Feb 26, 2021. The opportunity in biopharmaceuticals is big and growing too rapidly to ignore. Today, biopharmaceuticals generate global revenues of $163 billion, making up about 20 percent of the pharma market. Chaired by Dr Dinesh Dua, Chairman, Pharmexcil, & Executive Director, Nectar Lifesciences Limited, the conference will cover the nuances of Bio-Pharmaceuticals – the 360 degree approach to address move from the scientific frontier to the business mainstream; while the Digital Transformation session will reassess many of the strategies, technologies, and operational approaches; Supply Chain & Logistics – which is enabling the operational and technological challenges. Welcoming the members of advisory board , he said, “This exposition and conference comes absolutely and appropriately in time to: one, make sure we invite the Indian participants and researchers to show that now is the time that we move up the value chain and two, why not innovation? Innovation in Biologics is right there. The amount of collaboration which is happening between academia and the industry as compared to 10 years is absolutely tremendous. In such a situation, it’s an honour and a pleasure to be heading this excellent committee. This might well mark a revolution in the biopharmaceutical space. I expect India to be a major force to reckon with in biosimilar space” The conference will also focus on the Bio Start-ups through the Accelerating Bio-Innovations to Marketplace session. The idea is to sculpt the future of Bio-innovation in India. Chaired by Dr Uday Saxena, Co-Founder, Reagene Biosciences the session will showcase entrepreneurs and innovators producing new research which are driving the next wave of innovation and start-up ecosystem. To drive the agenda of the conference and to fulfil its potential to garner attention to field of Biopharmaceuticals and to successfully navigate the promises and challenges of this segment, ChemTECH has partnered with BIORx Venture Advisors Private Limited. As the Knowedge Partner to the conference, Vishal Gandhi, Founder & CEO said, “BIORx is very excited to partner for the second time with this forum to deepen our commitment to promote the Biopharmaceuticals emerging opportunity globally. We not only see big corporates making a strong commitment for R&D but Start ups are equally excited about the much needed relief of targeted molecular therapies and this platform will involve 360 degree view and hopefully position India as a BioPharma hub on the world map given its strengths in Pharmaceuticals and Biotechnology”. ]]> <![CDATA[Immuneel opens India’s first integrated cell therapy development & manufacturing facility]]> https://biospectrumindia.com/news/95/17958/immuneel-opens-indias-first-integrated-cell-therapy-development-manufacturing-facility.html https://biospectrumindia.com/news/95/17958/immuneel-opens-indias-first-integrated-cell-therapy-development-manufacturing-facility.html Mon, 18 Jan 2021 00:00:00 +0530 Immuneel Therapeutics Private Limited (Immuneel) has announced the inauguration of India's first Integrated Cell Therapy Development and Manufacturing Facility in Bengaluru. Located in Narayana Hrudayalaya Health City, the 12,000-sq. ft. integrated facility includes a state-of-the-art laboratory, cGMP-compliant manufacturing suites which will bring breakthrough cell and gene therapies to millions of patients in India. The facility is compliant with Indian Gene Therapy Product (GTP) guidelines released in 2019 and Global cGMP guidelines for advanced therapy medicinal products (ATMP) published by EMA and USFDA with a focus on manufacturing and quality systems specific to cell therapies. Dr Renu Swarup, (Secretary, Department of Biotechnology, Govt. of India) inaugurated the facility in the presence of Dr Devi Shetty (Chairman, Narayana Health), Ms Kiran Mazumdar Shaw (Co-Founder, Immuneel Therapeutics) & Dr Arun Anand (COO, Immuneel Therapeutics). This multi-product multi-process facility will currently focus on autologous cell therapies including CAR-T cell therapy for lymphomas & leukemias (haeme malignancies) and in future other forms of solid tumors, allogeneic cell therapy and beyond cell therapy and oncology in future. The Center of Excellence for cell manufacturing will ensure reproducibility, scalability, data integration for optimizing efficiency and monitoring performance which will bring in high-quality, world class, cost-effective cell therapy manufacturing capability. In her keynote address Dr Renu Swarup, Secretary Department of Biotechnology, Govt. of India, said “Immuneel’s facility inauguration is a significant milestone for India as it enables India to have an integrated facility that develops advanced technologies and delivers cutting edge therapies. Immuneel’s mission of providing affordable, high quality therapy fulfils the ambitions of the Government’s Atmanirbhar Bharat program towards a self-reliant nation that also serves the world. Immuneel will play a role as the central anchor for cell & gene therapy in India.” ]]> <![CDATA[Parexel, Signify Health to improve patient access to clinical trials]]> https://biospectrumindia.com/news/95/17948/parexel-signify-health-to-improve-patient-access-to-clinical-trials.html https://biospectrumindia.com/news/95/17948/parexel-signify-health-to-improve-patient-access-to-clinical-trials.html Fri, 15 Jan 2021 19:05:00 +0530 Parexel and Signify Health have announced a strategic collaboration to provide customers with new solutions to enable access to a more diverse and traditionally underrepresented population for their clinical trials. The partnership will focus on improving patient access to clinical trials, bringing studies to patients in their own homes, and identifying relevant social determinants of health (SDoH) to facilitate connections among local resources, patients, and caregivers. “Simply saying clinical trial diversity is ‘important’ is not enough,” said Peyton Howell, Executive Vice President and Chief Commercial & Strategy Officer, Parexel. “To correct the disparities in healthcare and drive more inclusion in clinical trials, we first must achieve a more holistic understanding of the non-medical factors that influence patient lives. Signify Health’s analytics and technology platform will enable us to use these insights to better understand the social and societal factors impacting inclusion — a key requirement to ensuring diversity in clinical trials.” “Through our mobile, national network of providers, we already have activated the home as an alternative site for baseline patient assessments and first dose observation for specialty drugs,” said Kyle Armbrester, CEO, Signify Health. “Alongside this clinical support, we are identifying and addressing the social co-morbidities that impact a person’s ability to access the care they need. It is particularly exciting to be working with Parexel on ways to leverage these capabilities to support both patients, and their caregivers, who want to participate in clinical trial programmes for potentially life-changing therapies.” Over the coming months, the companies will explore opportunities to address social determinants of health issues as part of the clinical trials recruitment and management. ]]> <![CDATA[Quantumzyme to hold workshop on atomistic details of SARS-CoV-2]]> https://biospectrumindia.com/news/95/17944/quantumzyme-to-hold-workshop-on-atomistic-details-of-sars-cov-2.html https://biospectrumindia.com/news/95/17944/quantumzyme-to-hold-workshop-on-atomistic-details-of-sars-cov-2.html Fri, 15 Jan 2021 16:55:00 +0530 A Coronavirus strain, SARS-CoV-2 was discovered in December 2019 for causing an outbreak of respiratory disease and pneumonia in Wuhan, China. Since then, the novel coronavirus has spread around the world, sickening more than 87 million people till January 7, 2021. One year has passed and still, scientists around the world continue to struggle to find a cure for the virus. For developing a new drug, it is essential to know the atomistic details and the dynamical nature of the virus. To give an insight of different computational tools and algorithm Quantumzyme is organising a two day workshop on ‘Advanced Molecular Modelling and Simulations’ ‘SARS-CoV- 2 Case Study’ on Jan 29 & 30 2021. The workshop will provide a sequence to structural insights to understand the atomistic details and the dynamics nature of the virus. The workshop aims to provide insight into various aspects of computational biology such as molecular modelling, molecular docking, molecular dynamics, quantum mechanical calculations along with scripting language. National and international speakers from industry and academia will participate in the workshop. Inaugural address will be given by Narayanan Suresh, Chief Operating Officer, Association of Biotech Enabled Enterprise (ABLE) followed-by sessions from eminent speakers like Dr Sakshi Piplani from Vaxine Pty Ltd,  Dr Shubhandra Tripathi from IIT Kanpur, Dr Mithun Radhakrishna from IIT Gandhinagar, Dr Kaushik Chakraborty from IIT Kanpur and Prof. Jiri Damborsky from Masaryk University from the Czech Republic. The closing remark will be given by Prof Nisanth Nair from IIT Kanpur. Alongside the experienced team from Quantumzyme will provide several hands-on sessions and talks. ]]> <![CDATA[Bharat Biotech to supply COVAXIN to Brazil]]> https://biospectrumindia.com/news/95/17935/bharat-biotech-to-supply-covaxin-to-brazil.html https://biospectrumindia.com/news/95/17935/bharat-biotech-to-supply-covaxin-to-brazil.html Thu, 14 Jan 2021 13:40:00 +0530 Bharat Biotech announced that it has signed an agreement with Precisa Medicamentos for the supplies of COVAXIN™ to Brazil. A team from Precisa Medicamentos has visited the Bharat Biotech facility last week to discuss potential export possibilities of COVAXIN™, India’s first indigenous vaccine for COVID-19. The team met Dr Krishna Ella, Chairman and Managing Director, Bharat Biotech on the January 7-8 at the Bharat Biotech facility in Genome Valley, Hyderabad. During the discussion, André Aranha Corrêa do Lago, Ambassador of Brazil to India, joined on a virtual platform. He expressed his keen interest on behalf of the Govt of Brazil, towards the procurement of COVAXIN™. In principle, it is understood between both parties that supplies of COVAXIN™ to be prioritised for the public market, through a direct procurement by the Govt of Brazil. Supplies to the private market would be based upon receipt of market authorisation from ANVISA, the Brazilian regulatory authority. Pleased with the interest expressed by the Brazilian government, Dr Ella said COVAXIN™ is an innovation and a perfect example of novel product development from India. Our goal for all vaccines developed at Bharat Biotech is to provide global access to populations that need it the most. COVAXIN™ has generated excellent safety data with robust immune responses to multiple viral proteins that persist. We are happy to note that vaccines innovated in India are able to address the public health needs of Brazil. ” After the technical visit to Bharat Biotech's Genome Valley facility in Hyderabad, Emanuela Medrades, Pharmaceutical Director, Precisa Medicamentos, said “Bharat Biotech has exceeded our expectations, demonstrating quality and safety at the level of the largest vaccine suppliers in the world.” ]]> <![CDATA[HMD ropes in Envigo to boost brand recognition ]]> https://biospectrumindia.com/news/95/17928/hmd-ropes-in-envigo-to-boost-brand-recognition-.html https://biospectrumindia.com/news/95/17928/hmd-ropes-in-envigo-to-boost-brand-recognition-.html Tue, 12 Jan 2021 17:15:00 +0530 Envigo, a Gurugram based full-service digital marketing and web analytics agency, has announced that it has been on-boarded as a digital marketing partner by Hindustan Syringes and Medical Devices Ltd. (HMD), one of India’s leading medical device manufacturers. Envigo will work to enhance HMD's online visibility, providing a bouquet of digital services which include social media management, content marketing, 3D and 2D video production, web analytics, SEO (Search Engine Optimisation), and paid marketing, among others. The services are aimed at boosting brand recognition, increasing online engagement, and driving inbound traffic to the HMD website. “We are very pleased to have Envigo partner with us,” said Sohail Nath, Director, HMD Ltd. “We were impressed by their proactive approach and refreshingly out-of-the-box ideas for our digital campaign. This is an agency with the right experience and expertise to help us drive our digital growth and we look forward to fortifying this mutually beneficial relationship.” “It is an honour to be working with HMD Ltd,” said Santosh Singh, Vice-President, Digital Marketing, Envigo. “We’re tremendously excited to be crafting innovative digital marketing strategies for India’s top manufacturer of medical devices. Besides, this is an opportunity for us to support HMD in a small way in their battle against COVID-19,” he added. HMD Ltd joins an expanding client roster of industry giants at Envigo. The list includes ITC Hotels, IndusInd Bank, ManipalCigna Health Insurance, Randstad India, Henkel Loctite and Careers360. ]]> <![CDATA[Dr Reddy’s submits phase 2 safety data of Sputnik V for DCGI’s approval]]> https://biospectrumindia.com/news/95/17927/dr-reddys-submits-phase-2-safety-data-of-sputnik-v-for-dcgis-approval.html https://biospectrumindia.com/news/95/17927/dr-reddys-submits-phase-2-safety-data-of-sputnik-v-for-dcgis-approval.html Tue, 12 Jan 2021 13:30:00 +0530 Dr Reddy’s Laboratories Ltd has announced that the independent Data and Safety Monitoring Board (DSMB) has reviewed the safety data from the phase 2 clinical trial of the Sputnik V vaccine and recommended the phase 3 recruitment and continue the clinical trial without any modifications. The phase 2 study of Sputnik V was conducted on 100 subjects as part of the randomised, double-blind, parallel-group, placebo-controlled study in India. The DSMB concluded that no safety concerns were identified and the study has met the primary endpoints of safety. Further, the safety data has been submitted to the Drugs Controller General of India (DCGI) for review and approval to continue phase 3 clinical trials. GV Prasad, Co-chairman and Managing Director, Dr Reddy’s Laboratories said, “The phase 2 study in India showed a very good safety profile. This further reinforces our confidence in the safety of Sputnik V, which has now been administered to more than 1 million people in Russia and more than 300,000 people in Argentina. We are working closely towards fast-tracking the launch of the Sputnik V vaccine in India.” Kirill Dmitriev, CEO of the Russian Direct Investment Fund, said, “The safety data from the phase 2 clinical trial from India is very positive, and confirms the safety profile of Sputnik V in the international markets.” The clinical trials are being conducted by JSS Medical Research as the clinical research partner in India. Dr Reddy’s has partnered with the Biotechnology Industry Research Assistance Council (BIRAC), Department of Biotechnology (DBT) for advisory support, THSTI (Translational Health Science and Technology Institute) for further immunogenicity data characterisation, and to use BIRAC’s clinical trial centres for the vaccine. ]]> <![CDATA[Dr Reddy’s launches FDA-approved generic Uloric tablets]]> https://biospectrumindia.com/news/95/17924/dr-reddys-launches-fda-approved-generic-uloric-tablets.html https://biospectrumindia.com/news/95/17924/dr-reddys-launches-fda-approved-generic-uloric-tablets.html Mon, 11 Jan 2021 18:40:00 +0530 Dr Reddy’s Laboratories Ltd has announced the launch of Febuxostat tablets, a therapeutic equivalent generic version of Uloric (Febuxostat) tablets approved by the US Food and Drug Administration (US FDA). The Uloric brand and generic had US sales of approximately $108 million MAT for the most recent twelve months ending in October 2020 according to IQVIA Health. Dr Reddy’s Febuxostat tablets are available in 40 mg and 80 mg strengths in bottle count sizes of 30 tablets. ]]> <![CDATA[Neuberg Supratech launches RT-PCR test counter at Sardar Vallabhbhai Patel International Airport]]> https://biospectrumindia.com/news/95/17920/neuberg-supratech-launches-rt-pcr-test-counter-at-sardar-vallabhbhai-patel-international-airport.html https://biospectrumindia.com/news/95/17920/neuberg-supratech-launches-rt-pcr-test-counter-at-sardar-vallabhbhai-patel-international-airport.html Mon, 11 Jan 2021 17:25:00 +0530 Neuberg Supratech has launched a round-the-clock RT-PCR test counter for flyers at Sardar Vallabhbhai Patel International Airport. The test conducted is fully in adherence to the standards mandated by the Indian Council of Medical Research (ICMR) and the state government, which aims to provide a quick and accurate diagnosis to travellers. The airport management has undertaken this step to enable travellers to take necessary measures to prevent transmission. The test is available for all international arrivals as well as to domestic travellers arriving and departing from the airport. The hard copy of the test result will be given within 6-8 hours to all the passengers undergoing COVID-19 test. Dr Sandip Shah, Executive Director, Neuberg Diagnostics said, “In tandem with Ahmedabad Airport, we have set up a RT-PCR test counter for increasing the testing capacity. In case the report is positive, then as per guidelines, the subsequent measures will be undertaken. This initiative will ensure the convenience of travellers as well as will help manage the rush of back-to-back flight arrivals smoothly.” ]]> <![CDATA[Boehringer Ingelheim targets medical breakthroughs with Google Quantum AI ]]> https://biospectrumindia.com/news/95/17918/boehringer-ingelheim-targets-medical-breakthroughs-with-google-quantum-ai-.html https://biospectrumindia.com/news/95/17918/boehringer-ingelheim-targets-medical-breakthroughs-with-google-quantum-ai-.html Mon, 11 Jan 2021 17:00:00 +0530 Boehringer Ingelheim (BI) has announced a collaborative agreement with Google Quantum AI (Google), focusing on researching and implementing cutting-edge use cases for quantum computing in pharmaceutical research and development (R&D), specifically including molecular dynamics simulations. The new partnership combines Boehringer Ingelheim’s leading expertise in the field of computer-aided drug design and in silico modeling with Google’s outstanding resources as one of the leading developers of quantum computers and algorithms. Boehringer Ingelheim is the first pharmaceutical company worldwide to join forces with Google in quantum computing. The partnership is designed for three years and is co-led by the newly established Quantum Lab of Boehringer Ingelheim. “We are really excited about joining forces with Google, the leading tech company when it comes to quantum computing,” says Michael Schmelmer, Member of the Board of Managing Directors, Boehringer Ingelheim with responsibility for Finance and Corporate Functions.  The new collaboration is part of Boehringer Ingelheim’s comprehensive digital transformation strategy with the aim to better leverage and accelerate the company’s promising pipeline and ultimately bringing more medical breakthroughs to patients in need.  “Boehringer Ingelheim brings both an impressive quantum computing team and deep expertise in real world applications of these capabilities in the pharmaceuticals space,” says Ryan Babbush, Head, Quantum Algorithms, Google.  Michel Pairet, Member of the Board of Managing Directors, Boehringer Ingelheim with responsibility for the company’s Innovation Unit said, “Together with Google, our goal is to apply the use of quantum computing in biopharmaceutical R&D and thus continue to make a decisive contribution to medical progress for patients around the world.” We are looking forward to jointly working on the field with fundamental research and a joint vision for solving relevant pharma problems in the beyond-classical regime over the next decade,” says Markus Hoffmann, Google Quantum AI Partnerships. ]]> <![CDATA[Intas Pharma inks licensing agreement with Korean firm to develop new products]]> https://biospectrumindia.com/news/95/17907/intas-pharma-inks-licensing-agreement-with-korean-firm-to-develop-new-products.html https://biospectrumindia.com/news/95/17907/intas-pharma-inks-licensing-agreement-with-korean-firm-to-develop-new-products.html Fri, 08 Jan 2021 17:00:00 +0530 South Korean firm Alteogen Inc has announced that it has entered into an exclusive license agreement with Ahmedabad based Intas Pharmaceuticals Ltd to use ALT-B4, Alteogen’s novel hyaluronidase – derived utilising the Hybrozyme™ technology – to develop and commercialise two products. Under the terms of the agreement, Alteogen has granted worldwide rights, except for a few Asian countries, for Intas to develop two products in combination with ALT-B4. Alteogen will receive an initial payment of $6 million and is also eligible to receive additional milestones upon Intas’ achievement of specified development, regulatory and sales milestones, totalling up to $109 million. In addition, Alteogen will be entitled to receive a tiered royalty ranging from mid-single digit to low double digit on sales of commercialised products. Alteogen will be responsible for regulatory development and commercial supply of ALT-B4 to Intas. Dr Soon Jae Park, Chief Executive Officer, Alteogen said, “We look forward to collaborating with Intas in bringing two products to the market for the benefit of patients.” Binish Chudgar, Vice Chairman, Intas Pharmaceuticals said, “This agreement underlines our vision and commitment to increasing access to life-changing medicines that can make a real difference to patient lives.” ]]> <![CDATA[ FDA approves Lupin's Empagliflozin, Metformin Hydrochloride ER tablets]]> https://biospectrumindia.com/news/95/17903/-fda-approves-lupins-empagliflozin-metformin-hydrochloride-er-tablets.html https://biospectrumindia.com/news/95/17903/-fda-approves-lupins-empagliflozin-metformin-hydrochloride-er-tablets.html Thu, 07 Jan 2021 17:35:00 +0530 Lupin Limited, a global pharmaceutical company, announced that it has received tentative approval for its Empagliflozin and Metformin Hydrochloride Extended-Release (ER) tablets, 5 mg/1000 mg, 10 mg/1000 mg, 12.5 mg/1000 mg, and 25 mg/1000 mg, from the United States Food and Drug Administration, to market a generic equivalent of Synjardy® XR tablets, 5 mg/1000 mg, 10 mg/1000 mg, 12.5 mg/1000 mg, and 25 mg/1000 mg, of Boehringer Ingelheim Pharmaceuticals, Inc. The product will be manufactured at Lupin’s Nagpur facility in India. Empagliflozin and Metformin Hydrochloride Extended-Release (ER) Tablets, 5 mg/1000 mg, 10 mg/1000 mg, 12.5 mg/1000 mg, and 25 mg/1000 mg, are indicated as an adjunct to diet and exercise, to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both empagliflozin and metformin hydrochloride is appropriate. Empagliflozin and Metformin Hydrochloride ER Tablets (RLD: Synjardy®XR) had estimated annual sales of $357 million in the US (IQVIA MAT November 2020). ]]> <![CDATA[PLUSS gets European patent for precise temperature-controlled box]]> https://biospectrumindia.com/news/95/17902/pluss-gets-european-patent-for-precise-temperature-controlled-box.html https://biospectrumindia.com/news/95/17902/pluss-gets-european-patent-for-precise-temperature-controlled-box.html Thu, 07 Jan 2021 17:30:00 +0530 PLUSS Advanced Technology (PLUSS), a material solutions company based in Gurugram, has announced that it has been granted patent by European Patent Office, Germany for its ‘Celsure’ box designed and manufactured using the proprietary Phase Change Material (PCM) technology, to transport vaccines and perishable commodities at a specific temperature range. The patent was granted to the innovative method of arranging PCMs which leads to precise temperature control in varying ambient conditions and increases operational efficiencies for the end user. The patent has also been applied in the US, Singapore, Brazil and India. PLUSS expects these patents to be granted soon as well. “The technology is already commercialised and is used by various multinational pharmaceutical and logistics companies in India. We are in conversations with COVID-19 vaccine distribution stakeholders to make our products available across the country. The latest MoU being with Spice Jet” said Samit Jain, MD, PLUSS. Celsure is a simple box-in-box transport solution developed by the R&D team at PLUSS which uses indigenously developed Phase Change Material (PCM) that will maintain the right temperature from a few hours to a few days to ensure that vaccines retain their potency. PLUSS has designed nearly 40 different PCM solutions for different temperatures, ranging from -77°C to + 89°C.   ]]> <![CDATA[Milagrow launches advanced duct cleaning robots for healthy air]]> https://biospectrumindia.com/news/95/17897/milagrow-launches-advanced-duct-cleaning-robotsfor-healthy-air.html https://biospectrumindia.com/news/95/17897/milagrow-launches-advanced-duct-cleaning-robotsfor-healthy-air.html Thu, 07 Jan 2021 00:00:00 +0530 To increase the safety of people working or living in enclosed environments, Gurugram based firm Milagrow has launched two advanced industry-grade duct cleaning robots. Milagrow Hydra & Milagrow Viper. Both the robots help with cleaning accumulated dirt, dust smut, etc in rectangular or round air ducts with a diameter between 100-350mm. This will be useful for facility managers across corporates, factories, hotels, restaurants, airports, healthcare companies, etc. The latest addition to Milagrow’s product portfolio, Hydra is the world’s most versatile duct cleaning robot that cleans large and medium-sized rectangular or round ducts between 250-1000 mm in size. It can also climb up to 30 degrees. Meanwhile, Milagrow Viper is the world’s thinnest, lightest, portable, compact, powerful duct cleaner that cleans round and rectangular ducts between 100-350mm. It comes with three PA 66 nylon brushes that have long durability and spins both sides and cleans efficiently without damaging the duct. Priced at Rs 1,199,000 and Rs 3,99,000 respectively, both Hydra and Viper come with a 1 year comprehensive warranty.  Speaking on the launch, Rajeev Karwal, Founder, Chairman Milagrow Robots, said, “Cleaning and maintaining Air Ducts was a very difficult task for facility managers and the launch of Milagrow Hydra and Viper air duct cleaning robots shall go a long way to make the task safe and also freeing up the time of manpower for higher value-added jobs.”    ]]> <![CDATA[ENTOD Pharma launches app to alert patients about expired eye medications]]> https://biospectrumindia.com/news/95/17896/entod-pharma-launches-app-to-alert-patients-about-expired-eye-medications.html https://biospectrumindia.com/news/95/17896/entod-pharma-launches-app-to-alert-patients-about-expired-eye-medications.html Wed, 06 Jan 2021 17:30:00 +0530 Most eye drugs prescribed for managing different eye-related conditions come with a strict expiry of 30 days after opening. However, most patients fail to discard the prescribed solutions within the stipulated time, leading to a risk of complications or possibility of eye irritation. To address this concern, Mumbai based ENTOD Pharmaceuticals has introduced a new smart solution in the form of a mobile reminder application OpenRx Timer. Developed by ENTOD owned healthcare tech company Brainovations Education Excellence Pvt Ltd, OpenRx Timer is an app that acts as a patient guide to enable the right management and usage of eye drugs. Using this free of cost mobile application will prevent patients from using expired eye drops that can put their eye health at risk. “The OpenRx Timer is a simple yet smart and innovative mobile application that records the opening date of the eye medicine and reminds patients when to discard them,” explained Nikkhil K Masurkar, Executive Director, ENTOD Pharmacetuicals.  OpenRx Timer app is a simple and user-friendly app that can set reminders easily in a matter of seconds and with just a few clicks. Downloading the OpenRx Timer app on your smartphone will enable you to receive timely notifications of when to discard any opened eye medicines.    ]]> <![CDATA[Indifi partners with Retailio for strengthening pharma presence]]> https://biospectrumindia.com/news/95/17894/indifi-partners-with-retailio-for-strengthening-pharma-presence.html https://biospectrumindia.com/news/95/17894/indifi-partners-with-retailio-for-strengthening-pharma-presence.html Wed, 06 Jan 2021 14:40:00 +0530 Following its successful foray into the pharma segment, Indifi is strengthening its presence in this space further. As part of this initiative, the leading MSME lending platform has partnered with Retailio, India's largest B2B pharma marketplace. Through this association, Indifi will be pre-approving and providing pharma retailers with its curated credit options to meet small working capital requirements throughout India.  Retailio, a platform used by retailers to order products from distributors and make payments to them, will now have a lending option as well. Retailers can now take small loans from Indifi’s tech-driven lending platform, and ensure smooth working capital management. The partnership allows Indifi to cater to around 100,000 retailers already present on the Retailio platform. Indifi’s CEO & Founder, Alok Mittal said, “By collaborating with Retailio, we aim to equip retailers with credit facilities to buy inventory from suppliers and ensure timely and seamless procurement in the process.” Rupesh Pathak, Director - Retailio said “We are committed to driving growth & sales within the pharma ecosystem by providing the best in class services on our platform.” ]]> <![CDATA[Sun Pharma initiates Ph 2 trial of plaque psoriasis drug]]> https://biospectrumindia.com/news/95/17893/sun-pharma-initiates-ph-2-trial-of-plaque-psoriasis-drug.html https://biospectrumindia.com/news/95/17893/sun-pharma-initiates-ph-2-trial-of-plaque-psoriasis-drug.html Tue, 05 Jan 2021 18:40:00 +0530 Sun Pharmaceutical Industries Limited has announced that it has initiated Phase 2 clinical trial for SCD-044 (a novel, orally bioavailable sphingosine-1-phosphate (S1P) receptor 1 agonist) in patients with moderate to severe plaque psoriasis. The Phase 2 study is a randomised, double-blind, placebo-controlled study to assess the efficacy and safety of SCD-044 in the treatment of moderate to severe plaque psoriasis. The study will enroll approximately 240 subjects and topline results are expected in 2022. SCD-044 is also being evaluated in other autoimmune disorders and Phase 2 studies for other indications like atopic dermatitis, are also expected to be initiated soon. In May-2020, Sun Pharma entered into a worldwide in-licensing agreement with Sun Pharma Advanced Research Company Ltd. (SPARC) for the development and commercialisation of SCD-044, which is being evaluated as a potential oral treatment for psoriasis, atopic dermatitis and other auto-immune disorders. ]]> <![CDATA[Trane Technologies launches cold chain solutions for COVID-19 vaccines in India ]]> https://biospectrumindia.com/news/95/17891/trane-technologies-launches-cold-chain-solutions-for-covid-19-vaccines-in-india-.html https://biospectrumindia.com/news/95/17891/trane-technologies-launches-cold-chain-solutions-for-covid-19-vaccines-in-india-.html Tue, 05 Jan 2021 18:15:00 +0530 Thermo King, by Trane Technologies, a global climate innovator, has launched its expanded portfolio of cold chain solutions in India, which can keep vaccines at temperatures from a range of +25 degrees Celsius to as low as -70 degrees Celsius.  The company’s advanced cold chain technologies will help address the unique challenges of COVID-19 vaccine distribution in India, whose large population is spread across vast and varied geographies, from densely populated cities to far-flung rural communities. Allen Ge, President, Trane Technologies, Asia Pacific said, “Our recently launched SuperFreezers were initially developed to flash-freeze high-end seafood. Our teams quickly adapted and developed a good solution for COVID-19 vaccines transport, which require ultra-cold temperatures to prevent degradation.”  Thermo King’s end-to-end transport and storage solutions are flexible and able to scale up and down based on demand. Particularly, when ultra-low temperatures is needed, the SuperFreezers can provide transport and storage capability with an ultra-low set point of -70C and can store up to 60 times more doses compared to traditional reach-in freezers in use today. “We are actively engaging with third-party logistics companies, policymakers, regulators and other industry partners to find ways to strengthen the vaccine cold chain,” said Kishor Patil, Trane Technologies HVAC & Transport, India & SAARC Country leader. ]]> <![CDATA[Alniche Lifesciences steps into pharma manufacturing]]> https://biospectrumindia.com/news/95/17879/alniche-lifesciences-steps-into-pharma-manufacturing.html https://biospectrumindia.com/news/95/17879/alniche-lifesciences-steps-into-pharma-manufacturing.html Sat, 02 Jan 2021 00:00:00 +0530 Alniche Lifesciences, based in New Delhi, has ventured into manufacturing in its state-of-the-art facility under the name of EffiKasia Lifesciences at Kangra, Himachal Pradesh. EffiKasia Lifesciences will manufacture pharmaceuticals, nutraceuticals and dermatologicals. With this initiative, Alniche plans to increase its profit margins and push top-line by expanding sales operations for Exports in semi-regulated markets. Additionally, with its own manufacturing setup, the company plans to compete in the institutional tender business thus setting up a new business vertical. EffiKasia is in discussions with various global companies to acquire unique technology platform and by leveraging these technologies, the team of scientists in its R&D will introduce a whole new range of differentiated formulations in the domestic and exports markets. In the future, the company plans to expand its manufacturing capacities to contract-manufacture for others, thus making its mark in the CMO space. Girish Arora, Founder & Managing Director of Alniche shared, “With our growing sales across various therapy-verticals, there has always been a need for back-end integration by setting up our manufacturing plant. Initially, EffiKasia will manufacture exclusively for Alniche and in the future expand its base as a reliable contract-manufacturing company.” ]]> <![CDATA[Zydus to initiate Ph III trials of COVID-19 vaccine candidate]]> https://biospectrumindia.com/news/95/17870/zydus-to-initiate-ph-iii-trials-of-covid-19-vaccine-candidate.html https://biospectrumindia.com/news/95/17870/zydus-to-initiate-ph-iii-trials-of-covid-19-vaccine-candidate.html Fri, 01 Jan 2021 00:00:00 +0530 Zydus Cadila has announced that its plasmid DNA vaccine to prevent COVID-19, ZyCoV-D was found to be safe, well tolerated and immunogenic in the Phase I/II clinical trials. The company is now planning to initiate Phase III clinical trial in around 30,000 volunteers upon receiving necessary approvals. The Phase II study of the vaccine ZyCoV-D had been conducted in over 1000 healthy adult volunteers as part of the adaptive Phase I/II dose escalation, multi-centric, randomised, double-blind placebo controlled study. The vaccine was found to be safe and immunogenic. The trial has been reviewed by an independent Data Safety Monitoring Board (DSMB) and reports have been submitted to Central Drugs Standard Control Organisation (CDSCO) regularly for the update on safety outcome. Speaking on the development, Pankaj R Patel, Chairman, Zydus Group said, “After establishing safety in Phase I clinical trial, ZyCoV-D has now completed Phase II clinical trials and the vaccine has been found to be safe and immunogenic. We are optimistic of Phase III clinical trial outcomes as well and that we would be able to start the production of the novel vaccine on its successful completion. I would like to thank all the volunteers who have participated in the study so far and helped us in evaluating the vaccine to fight COVID-19.” ]]> <![CDATA[Bharat Biotech partners with Ocugen to develop COVID-19 vaccine for US]]> https://biospectrumindia.com/news/95/17877/bharat-biotech-partners-with-ocugen-to-develop-covid-19-vaccine-for-us.html https://biospectrumindia.com/news/95/17877/bharat-biotech-partners-with-ocugen-to-develop-covid-19-vaccine-for-us.html Fri, 01 Jan 2021 00:00:00 +0530 Ocugen, Inc. and Bharat Biotech have announced that the companies have signed a binding letter of intent (LOI) to co-develop Bharat Biotech’s COVID-19 vaccine candidate, COVAXIN™, an advanced stage whole-viron inactivated vaccine candidate, for the United States market. COVAXIN™ has been evaluated in approximately 1,000 subjects in Phase 1 and Phase 2 clinical trials in India, with promising safety and immunogenicity data. The vaccine candidate is currently part of a Phase 3 clinical trial in India involving 26,000 volunteers. As per the LOI, Ocugen will have US rights to the vaccine candidate and, in collaboration with Bharat Biotech, will be responsible for clinical development, registration, and commercialization for the US market. The companies have begun collaborating and will finalize details of the definitive agreement in the next few weeks. This collaboration leverages Ocugen’s vaccine expertise, and its R&D and regulatory capabilities in the US. In preparation for the development of COVAXIN™ in the US, Ocugen has assembled a Vaccine Scientific Advisory Board featuring leading academic and industry experts to evaluate the clinical and regulatory path to approval in the US market. ]]> <![CDATA[Biological E, CEPI to jointly develop COVID-19 subunit vaccine candidate]]> https://biospectrumindia.com/news/95/17866/biological-e-cepi-to-jointly-develop-covid-19-subunit-vaccine-candidate.html https://biospectrumindia.com/news/95/17866/biological-e-cepi-to-jointly-develop-covid-19-subunit-vaccine-candidate.html Thu, 31 Dec 2020 00:00:00 +0530 CEPI, the Coalition for Epidemic Preparedness Innovations, based in Norway, and Biological E, a Hyderabad-based vaccines and pharmaceutical company, have announced a collaboration to advance the development and manufacture of Biological E’s COVID-19 subunit vaccine candidate. CEPI will initially contribute up to $5 million toward the cost of scaling up the process for manufacturing the vaccine, and will explore providing additional funding to Bio E with the goal of potentially enabling the production of 100 million doses in 2021. CEPI and Biological E are committed to global equitable access of COVID-19 vaccines and have agreed that vaccine output funded by CEPI’s investment will be made available for procurement and allocation, if proven to be safe and effective, through the COVID-19 Vaccine Global Access (COVAX) Facility. The COVAX Facility aims to ensure equitable access to COVID-19 vaccines for all countries, at all levels of development, that wish to participate. Dr Richard Hatchett, CEO of CEPI said, “To end the acute phase of the pandemic, and control the virus in the longer term, we will need a range of safe and effective vaccines that can be manufactured at scale to meet global demand for billions of doses, and deployed to a wide range of populations and settings so that nobody is left behind.” Mahima Datla, Managing Director, Biological E Limited said, “The initial investment from CEPI comes on the heels of investments from the Bill & Melinda Gates Foundation and the Government of India’s Biotechnology Industry Research Assistance Council (BIRAC), and provides the impetus for accelerated efforts towards a successful and scalable outcome for global access.”   ]]> <![CDATA[DCGI approves Zydus Cadila’s Saroglitazar Mg for NAFLD treatment]]> https://biospectrumindia.com/news/95/17869/dcgi-approves-zydus-cadilas-saroglitazar-mg-for-nafld-treatment.html https://biospectrumindia.com/news/95/17869/dcgi-approves-zydus-cadilas-saroglitazar-mg-for-nafld-treatment.html Thu, 31 Dec 2020 00:00:00 +0530 Zydus Cadila has announced that the Drug Controller General of India (DCGI) has approved its New Drug Application (NDA) for Saroglitazar Mg for the treatment of non-alcoholic fatty liver disease (NAFLD) in India. Speaking about the development, Pankaj Patel, Chairman, Zydus Group said, “With Saroglitazar Mg, we have been able to successfully offer an innovative medicine for dealing with chronic liver diseases like NAFLD and NASH and helping patients in leading healthier lives.” Saroglitazar Mg was launched in India in September 2013, for the treatment of diabetic dyslipidemia and hypertriglyceridemia in patients with type-2 diabetes not controlled by statins alone. In January this year, Saroglitazar Mg received an approval for the treatment of Type 2 Diabetes Mellitus. In March 2020, Saroglitazar Mg had received approval for the treatment of NASH. Zydus achieved positive results in the EVIDENCES III trial (CTRI/2015/10/006236), a Phase 3 liver biopsy trial of Saroglitazar Mg 4 mg versus Placebo in Indian patients with NASH. The trial evaluated histological improvement of NASH using liver biopsy at the end of 52 weeks and successfully met primary and secondary endpoints. Saroglitazar Mg 4 mg demonstrated a significant reduction in liver fat, liver enzymes and disease activity. Additionally, 15 investigator initiated clinical studies of Saroglitazar Mg have been presented and published in leading scientific journals and conferences. Saroglitazar Mg is a prescription drug approved in India, and should be taken under guidance of a registered medical practitioner. ]]> <![CDATA[Glenmark launches FDC Type 2 diabetes drug in India]]> https://biospectrumindia.com/news/95/17863/glenmark-launches-fdc-type-2-diabetes-drug-in-india.html https://biospectrumindia.com/news/95/17863/glenmark-launches-fdc-type-2-diabetes-drug-in-india.html Tue, 29 Dec 2020 17:20:00 +0530 Glenmark Pharmaceuticals has launched a fixed dose combination (FDC) of its novel, patent protected and globally researched Sodium Glucose Co-Transporter Inhibitor (SGLT2i) - Remogliflozin Etabonate and another widely used DPP4 inhibitor (Dipeptidyl Peptidase 4 inhibitor) - Vildagliptin, in India. The fixed dose combination is indicated for the management of Type 2 diabetes. The combination will contain Remogliflozin (100 mg) + Vildagliptin (50 mg) in a fixed dose and must be taken twice daily to improve glycemic control in patients. Glenmark has launched the same under two brand names Remo V and Remozen V. Glenmark is the first company in the world to launch Remogliflozin + Vildagliptin fixed dose combination and India is the first country to get access to this FDC drug. Glenmark received approval from the DCGI (the drug approval authority in India) for manufacturing and marketing Remogliflozin + Vildagliptin combination in late November 2020. While the average daily cost of therapy of existing brands in the same drug category is Rs 78,  Glenmark's Remogliflozin-Vildagiptin combination has been launched at a breakthrough price of Rs 14 per tablet, to be taken twice daily; which amounts to Rs 28 as the per day cost of therapy. This cost is 65% lower than the other available SGLT2 & DPP4 combination drugs in the market.  "We are glad to introduce this innovative fixed dose combination, which is cutting-edge, extensively researched and at an affordable cost for patients in the country," said Alok Malik, Group Vice President & Business Head, India Formulations. ]]> <![CDATA[Lupin launches Mycophenolate Mofetil tablets]]> https://biospectrumindia.com/news/95/17861/lupin-launches-mycophenolate-mofetil-tablets.html https://biospectrumindia.com/news/95/17861/lupin-launches-mycophenolate-mofetil-tablets.html Tue, 29 Dec 2020 16:40:00 +0530 Lupin Limited, a global pharmaceutical company, announced the launch of Mycophenolate Mofetil tablets USP, 500 mg, after Lupin’s alliance partner Concord Biotech Limited (Concord) received an approval for its ANDA from the United States Food and Drug Administration. Mycophenolate Mofetil tablets USP, 500 mg, are the generic equivalent of CellCept® tablets of Roche Palo Alto LLC, indicated for the prophylaxis of organ rejection in recipients of allogeneic kidney, heart or liver transplants, and should be used in combination with other immunosuppressants. Mycophenolate Mofetil tablets USP (RLD: CellCept®) had an annual sales of approximately $87 million in the US (IQVIA MAT October 2020). ]]> <![CDATA[Godrej ramps up medical refrigerator production for COVID-19 vaccine storage]]> https://biospectrumindia.com/news/95/17856/godrej-ramps-up-medical-refrigerator-production-for-covid-19-vaccine-storage.html https://biospectrumindia.com/news/95/17856/godrej-ramps-up-medical-refrigerator-production-for-covid-19-vaccine-storage.html Tue, 29 Dec 2020 14:40:00 +0530 To cater to the urgent demand for COVID-19 vaccine storage in India, Godrej has a range of vaccine refrigerators which operate in the precise temperature band of 2-8°C and now, also offers advanced medical freezers with cooling upto -20°C.  These temperature ranges are completely suited for the multiple COVID-19 vaccines being evaluated by India.  Powered by patented Sure Chill Technology, Godrej Medical Refrigerators help maintain the optimum temperature range of 2 to 8°C - a necessity for vaccine preservation, despite intermittent power outages. In the event of power outages, this refrigerator retains its temperature for as long as 8-12 days even at ambient temperatures of 43°C. The brand has received multiple orders valued close to Rs 150 crore from the central government, various state governments and international aid bodies as well, solely for the purpose of COVID-19 vaccine storage. It is also receiving enquiries now from PSUs who are joining the immunisation effort. Godrej Appliances has already ramped up medical refrigerator production capacity from 10,000 units per annum to 35,000 units per annum, to meet the growing demand. Commenting on these developments, Kamal Nandi, Business Head and Executive Vice President, Godrej Appliances said, “We are partnering with various stakeholders in strengthening the healthcare cold chain and aiming to solve other potential vaccine roll out challenges as well, to make India COVID-19 vaccine ready.” Jaishankar Natarajan, Associate Vice President and Head - New Business Development, Godrej Appliances further added “Currently, to meet the increasing demand, we have enhanced our production capacity of these specialised products by 250 percent.” ]]> <![CDATA[SpiceJet signs MoU with PLUSS for COVID-19 vaccine delivery ]]> https://biospectrumindia.com/news/95/17846/spicejet-signs-mou-with-pluss-for-covid-19-vaccine-delivery.html https://biospectrumindia.com/news/95/17846/spicejet-signs-mou-with-pluss-for-covid-19-vaccine-delivery.html Tue, 29 Dec 2020 00:00:00 +0530 SpiceJet has announced the signing of a Memorandum of Understanding (MoU) with Pluss Advanced Technologies (PLUSS) for the supply of indigenously developed precise temperature control boxes required of maintaining the effectiveness of the vaccine during transport. According to the MoU, PLUSS will supply its patented product – Celsure®, developed using its proprietary Phase Change Material technology, for transportation of the COVID-19 vaccines from the manufacturer to different parts of the country. The product will be co-branded especially for SpiceJet’s cargo division Spice Xpress and will be made available at various locations across the country. “We are particularly happy to join forces with SpiceJet to ensure the delivery of the vaccine using the safest and fastest mode. SpiceJet flies to many non-metro locations and that will help the vaccine reach to the rural hinterlands of India,” said Samit Jain, MD, PLUSS. “We can cover the length and breadth of the country through our partnerships with last mile logistics companies. We can deliver the vaccines within 48-72 hours to any part of the country and Pluss’ temperature control boxes will play a critical role in ensuring the safety and efficacy of the vaccine” said Sanjiv Gupta, CEO, Spice Jet-Cargo Division. PLUSS, funded by Tata Capital Innovation Fund, has made rapid strides in precise temperature control solutions using inhouse R&D and has several award-winning solutions and patents for pharma, building and logistics industries in India and overseas.     ]]> <![CDATA[Serum Institute launches India’s first indigenous pneumococcal vaccine]]> https://biospectrumindia.com/news/95/17845/serum-institute-launchesindias-first-indigenous-pneumococcal-vaccine.html https://biospectrumindia.com/news/95/17845/serum-institute-launchesindias-first-indigenous-pneumococcal-vaccine.html Mon, 28 Dec 2020 18:00:00 +0530 The Serum Institute of India has announced the launch of India’s first indigenously developed pneumococcal vaccine – PNEUMOSIL® in the presence of Dr Harsh Vardhan, Minister, Health and Family Welfare. It has been developed through a collaboration spanning over a decade among Serum Institute of India Pvt Ltd, PATH and Bill and Melinda Gates foundation. Driven by the philanthropic commitment of SII to protect every family with affordable vaccines, PNEUMOSIL® comes with the advantage of presence of stereotypes 6A & 19A. The composition of the WHO pre-qualified vaccine is specially tailored as per the prevalence of the Top 10 serotypes of S. pneumoniae in India and other regions of the world, which is the unique feature of this conjugate vaccine. The vaccine will provide effective and long-lasting protection for children against pneumococcal diseases. Speaking about the launch, Dr. Harsh Vardhan, Union Minister, Ministry of Health & Family Welfare said, “It is a great moment of pride to witness Serum Institute take forward the ‘Make in India’ legacy, with the launch of India’s first indigenously developed Pneumococcal Conjugate Vaccine. Talking about the launch of Pneumosil, Adar Poonawalla, CEO, Serum Institute of India shared, “While the vaccine itself is of the highest quality and grade available, vaccine accessibility is of utmost importance as well, and to ensure ease of access by making it available at an affordable price.” The vaccine makes the Serum Institute of India the world’s third supplier of pneumococcal conjugate vaccines (PCV) under the pneumococcal Advance Market Commitment (AMC), and the first developing country vaccine manufacturer to access the global PCV market. ]]> <![CDATA[Lupin launches Meloxicam capsules]]> https://biospectrumindia.com/news/95/17842/lupin-launches-meloxicam-capsules.html https://biospectrumindia.com/news/95/17842/lupin-launches-meloxicam-capsules.html Mon, 28 Dec 2020 16:20:00 +0530 Lupin Limited a global pharmaceutical company, announced the launch of Meloxicam capsules, 5 mg, and 10 mg, having received an approval from the United States Food and Drug Administration. Meloxicam capsules, 5 mg and 10 mg, is the generic equivalent of Vivlodex® capsules, 5 mg and 10 mg, of Zyla Life Sciences US, Inc, and indicated for management of osteoarthritis (OA) pain. Meloxicam capsules (RLD: Vivlodex®) had an annual sales of approximately $11 million in the US (IQVIA MAT October 2020). ]]> <![CDATA[Anupam Rasayan to raise Rs 760 crore via IPO for debt repayment ]]> https://biospectrumindia.com/news/95/17836/anupam-rasayan-to-raise-rs-760-crore-via-ipo-for-debt-repayment-.html https://biospectrumindia.com/news/95/17836/anupam-rasayan-to-raise-rs-760-crore-via-ipo-for-debt-repayment-.html Thu, 24 Dec 2020 17:50:00 +0530 Anupam Rasayan, speciality chemicals company has filed its DRHP with the regulators to raise an aggregate of Rs 760 crore. The issue proceeds would be used mainly for repayment of debt. As stated in the DRHP, the company may consider an employee discount for eligible employees bidding for the employee reservation portion. From FY18 to FY20, the company’s revenues have grown at CAGR of 24.29 per cent and its EBITDA for FY20 stood at Rs 134.90 crore. In spite of the lockdown imposed due to the COVID-19 pandemic the company’s half-yearly revenues increased by 51.51 per cent, ie from Rs 234.40 crore to Rs 355.12 crore for the comparable periods of September 30, 2019 and September 30, 2020, respectively. India’s specialty chemicals industry stands to achieve serious growth in the global speciality chemicals segment, as currently the Indian speciality chemicals segment caters to only 1-2% of the global demand and is poised to grow at a 10-11% CAGR over the next 5 years, due to the rising demand from end user industries globally. (Source: F&S Report) Bankers appointed to the issue are Axis Capital, Ambit Private, IIFL Securities and JM Financial. ]]> <![CDATA[SII, Dynavax undertake first participants dosing in Ph 1/2 trial of COVID-19 vaccine]]> https://biospectrumindia.com/news/95/17833/sii-dynavax-undertake-first-participants-dosing-in-ph-1-2-trial-of-covid-19-vaccine.html https://biospectrumindia.com/news/95/17833/sii-dynavax-undertake-first-participants-dosing-in-ph-1-2-trial-of-covid-19-vaccine.html Thu, 24 Dec 2020 13:55:00 +0530 Serum Institute of India (SII) has partnered with Dynavax Technologies Corporation, a biopharmaceutical company focused on developing and commercialising novel vaccines, and jointly announced that the first participants have been dosed in the Phase 1 part of the Phase 1/2 clinical trial evaluating SIIPL's vaccine candidate adjuvanted with CpG 1018 to prevent COVID-19. The Phase 1/2 clinical trial will evaluate the safety and immunogenicity of SIIPL's vaccine candidate consisting of the SARS-COV-2 virus receptor binding domain (RBD) delivered as a virus-like particle (VPL), along with Dynavax's advanced adjuvant CpG 1018 plus alum. The Phase 1 portion of the clinical trial will enrol 39 healthy volunteers and post the completion of the study a decision will be taken regarding the dosing of up to 216 subjects in Phase 2. Sharing his thoughts, Adar Poonawalla, Chief Executive Officer, Serum Institute of India, said, "The collaboration with Dynavax is our effort in developing and exploring avenues to bolster our fight against the pandemic. We are hopeful that delivering the CpG 1018 adjuvant in the vaccine will enhance the immune response of the candidate.” Ryan Spencer, Chief Executive Officer, Dynavax commented, "We believe continued development of multiple programmes is critical to ensure the availability of safe and effective vaccines that can protect the global population from this devastating disease in the near term and for years to come.” ]]> <![CDATA[Aurobindo Pharma inks agreement with COVAXX for COVID-19 vaccine development]]> https://biospectrumindia.com/news/95/17838/aurobindo-pharma-inks-agreement-with-covaxx-for-covid-19-vaccine-development.html https://biospectrumindia.com/news/95/17838/aurobindo-pharma-inks-agreement-with-covaxx-for-covid-19-vaccine-development.html Thu, 24 Dec 2020 00:00:00 +0530 Hyderabad based Aurobindo Pharma Limited and COVAXX, a US-based company, have entered into an Exclusive License Agreement to develop, commercialize and manufacture UB-612, the first Multitope Peptide-based Vaccine to fight COVID-19, for India and the United Nations Children's Fund (UNICEF) agency. COVAXX is currently conducting a Phase 1 clinical trial for the vaccine candidate.  Commenting on the development, N. Govindarajan, Managing Director, Aurobindo Pharma Limited, said: "We are proud to partner with COVAXX in developing the first-ever synthetic peptide-based vaccine to combat the COVID-19 pandemic. This vaccine has immense potential in eliminating shedding, and hence containing, the spread of the pandemic."    Under the signed agreement, Aurobindo Pharma has obtained the exclusive rights to develop, manufacture and sell COVAXX's UB-612 vaccine in India and to UNICEF, as well as non-exclusive rights in other select emerging and developing markets. Aurobindo Pharma and COVAXX are partnering on clinical development, manufacturing and marketing of COVAXX's vaccine candidate, UB-612. Aurobindo will manufacture the finished doses at its facilities in Hyderabad. Aurobindo has the capacity of manufacturing 220 million doses in multi-dose presentation and is building additional facilities to have a total capacity of nearly 480 million doses by June 2021.  ]]> <![CDATA[Medtronic brings new innovation in surgery with EEA™ circular stapler]]> https://biospectrumindia.com/news/95/17828/medtronic-brings-new-innovation-in-surgery-with-eeacircular-stapler.html https://biospectrumindia.com/news/95/17828/medtronic-brings-new-innovation-in-surgery-with-eeacircular-stapler.html Wed, 23 Dec 2020 14:25:00 +0530 India Medtronic Private Limited, a wholly owned subsidiary of Medtronic plc, has announced the launch of EEA™ Circular Stapler with Tri-Staple™ Technology - the first 3-row Circular Stapler with varied height staples. The new Tri-Staple™ Technology comprises a sloped cartridge face that delivers less stress on tissue. It also offers consistent performance over a broad range of tissue thickness and allows for greater perfusion into the staple line. The EEA™ circular stapler with Tri-Staple™ technology is indicated for use in colorectal procedures, where safer anastomosis (surgical connection between two loops of the intestine) is required to avoid any leaks. The device has three rows of varied height staples to deliver 30% more security to the staple line and requires 60% lesser firing force in the operating room as compared to current devices. Moreover, the device comes with improved audible and tactile feedback that enables clinicians with better decision-making in the operating room. Additionally, the tilt-top mechanism on the device facilitates easy removal during colorectal surgeries. The promise of higher security and greater perfusion at the staple line is expected to deliver better clinical outcomes for patients. “The Tri-Staple™ EEA™ circular stapler is the latest addition to Medtronic’s Tri-staple technology portfolio,” said Madan Krishnan, Vice President & Managing Director, India Medtronic Pvt Ltd. ]]> <![CDATA[Glenmark to commercialize Ryaltris™ nasal spray throughout Europe]]> https://biospectrumindia.com/news/95/17827/glenmark-to-commercialize-ryaltris-nasal-spray-throughout-europe.html https://biospectrumindia.com/news/95/17827/glenmark-to-commercialize-ryaltris-nasal-spray-throughout-europe.html Wed, 23 Dec 2020 13:30:00 +0530 Glenmark Pharmaceuticals Ltd, a research-led global integrated pharmaceutical company, has announced that its Swiss subsidiary, Glenmark Specialty SA, has entered into an exclusive licensing agreement with Menarini Group (Menarini) for commercialising its innovative nasal spray Ryaltris™ across 33 countries in Europe, including the Balkan region. Ryaltris™ [olopatadine hydrochloride (665 mcg) and mometasone furoate (25 mcg)], developed by Glenmark, is a novel fixed-dose combination nasal spray of an anti-histamine and a steroid, indicated for treatment of symptoms associated with seasonal allergic rhinitis (SAR) in patients over 12 years of age. Under the terms of the agreement, Glenmark will be responsible for the continued development and regulatory approval of Ryaltris™ in these markets. Menarini will be responsible for the scientific information and the commercialisation of Ryaltris™ in those markets, following regulatory approval. Glenmark will receive an upfront payment as well as launch & sales based milestone payments from Menarini for Ryaltris™ sales. "This partnership is another step in establishing Glenmark's respiratory focus in Europe. While Glenmark will launch Ryaltris™ through its own front ends in some markets, this arrangement will allow the product to compete across Europe," said Achin Gupta, Executive Vice President, Business Head EMEA-L (Europe, Middle East, Africa, Latam) Glenmark Pharmaceuticals.   ]]> <![CDATA[DCGI approves AstraZeneca’s eosinophilic asthma drug]]> https://biospectrumindia.com/news/95/17824/dcgi-approves-astrazenecas-eosinophilic-asthma-drug.html https://biospectrumindia.com/news/95/17824/dcgi-approves-astrazenecas-eosinophilic-asthma-drug.html Tue, 22 Dec 2020 17:05:00 +0530 AstraZeneca India, a leading science-led biopharmaceutical company, has received marketing authorisation from Drugs Controller General of India (DCGI) for - use of the original research medicine, Fasenra™ (Benralizumab solution for injection in a single dose prefilled syringe30 mg/ml subcutaneous administration only) in patients with severe asthma (eosinophilic asthma). Benralizumab (Fasenra™) is indicated as an add-on maintenance treatment for severe asthma with an eosinophilic phenotype in adult patients. Fasenra™ is an add-on maintenance treatment for patients with severe eosinophilic asthma. It is designed to target cells in the body called eosinophils, which are a key cause of the eosinophilic subtype of asthma. Fasenra™is not an inhaler or a steroid and is administered once in 8 weeks under the skin via injection as maintenance therapy.  Gagandeep Singh Bedi, Managing Director, AstraZeneca India, said “The regulatory approval of Fasenra™ in India will provide better medicine for the management of eosinophilic asthma and support patients to attain a better quality of life”. Dr Anil Kukreja, Vice President – Medical Affairs & Regulatory, AstraZeneca India said, “The marketing authorisation for Fasenra™ in India is based on the evidence collated over years, 6 phase III trials conducted globally on more than 11,000 patients, and patient exposure of more than 56000 patient years.” ]]> <![CDATA[Alma introduces new approach in Indian anti-ageing treatments market]]> https://biospectrumindia.com/news/95/17818/alma-introduces-new-approach-in-indian-anti-ageing-treatments-market.html https://biospectrumindia.com/news/95/17818/alma-introduces-new-approach-in-indian-anti-ageing-treatments-market.html Tue, 22 Dec 2020 00:00:00 +0530 Alma, one of the top five global leaders of energy-based medical and aesthetics solutions, has announced the launch of renowned European skin-remodelling brand, PROFHILO®, in India, offering a new breakthrough approach in skin anti-ageing. PROFHILO®, developed by the international pharma company, IBSA, created a new concept of ‘Bioremodeling’ in the dermal injectables industry, offering an overarching approach to skin ageing, beyond currently available solutions. PROFHILO® delivers a high concentration of pure Hyaluronic acid to different layers of the skin, promoting the multilevel and dynamic remodelling of extracellular matrix in terms of elasticity and support, while maintaining the viability of fibroblast, keratinocytes, and adipocytes to provide deep hydration and rejuvenation of the skin tissue. With 64 MG of hyaluronic acid per syringe, PROFHILO® delivers the highest concentration of this compound to the skin as compared to other HA-based treatments. PROFHILO® is administered using a proprietary injection technique, named Bio Aesthetic Points (BAP), which identifies five strategic points to deliver high concentration of pure Hyaluronic acid to different layers of the skin. The BAP technique allows progressive diffusion of the product across widest sections through sub-dermal patterns. “This exciting launch of PROFHILO® in India follows its successful launches in Israel and Hong-Kong, and soon in China.  Alma, a pioneer in Aesthetics Regenerative Medicine practices, is proud to introduce this new concept of bioremodeling, boosting the production of scaffolding proteins collagen and elastin in the deep layers of skin to address the source of skin laxity and wrinkles.” said Lior Dayan, Chief Executive Officer Alma.   ]]> <![CDATA[VOTIS, ii Ventures to develop system to screen peripheral artery disease]]> https://biospectrumindia.com/news/95/17816/votis-ii-ventures-to-develop-system-to-screen-peripheral-artery-disease.html https://biospectrumindia.com/news/95/17816/votis-ii-ventures-to-develop-system-to-screen-peripheral-artery-disease.html Mon, 21 Dec 2020 17:35:00 +0530 VOTIS Subdermal Imaging Technologies, Ltd, an Israeli corporation, and ii Ventures Private Limited (iiV), an Indian company, announced that they have entered into a memorandum of understanding to develop a system to screen the largely rural Indian population for peripheral artery disease (PAD). The devices, which allow for the early detection of the disease before tangible symptoms appear, will utilise the same technology that VOTIS is building into other devices intended for use in the US and Europe. Alfred Arambhan, Co-Founder and Mentor of iiV said, "There is a great need for a system that is convenient, accurate, and affordable. We have found it in the VOTIS technology." Arambhan continued, "Our initial plan is to establish VOTIS solutions in villages throughout India, and to create a robust and reliable platform for introducing and launching similar devices and solutions in the future. We are gratified that our plan has received encouragement and support from Governmental, private, and NGO sources in India." Merrill Weber, Chief Executive Officer and President, VOTIS said, "Our devices are entirely non-invasive and do not use X-rays (Roentgen) or other ionising radiation. They are inexpensive and dependable. In India, the screening devices will enable easy, intuitive use. That will permit testing to be performed by technicians and nurses in the villages rather than medical doctors at hospitals or clinics." The VOTIS devices use vascular optical tomographic imaging, or VOTI, an imaging technology developed under the leadership of Andreas Hielscher, Professor and Chair, Department of Biomedical Engineering, New York University Tandon School of Engineering. The technology was developed in Prof Hielscher's biophotonics and optical radiology laboratory, which he ran as professor of biomedical engineering, radiology and electrical engineering at the Fu Foundation School of Engineering and Applied Sciences at Columbia University. VOTIS plans to release its devices commercially in 2022. ]]> <![CDATA[Lupin receives US FDA approval for Colesevelam Hydrochloride tablets]]> https://biospectrumindia.com/news/95/17811/lupin-receives-us-fda-approval-for-colesevelam-hydrochloride-tablets.html https://biospectrumindia.com/news/95/17811/lupin-receives-us-fda-approval-for-colesevelam-hydrochloride-tablets.html Fri, 18 Dec 2020 18:15:00 +0530 Pharma major Lupin Limited announced that it has received approval for its Colesevelam Hydrochloride tablets, 625 mg, from the United States Food and Drug Administration (US FDA), to market a generic equivalent of Welchol® Tablets, 625 mg, of Daiichi Sankyo, Inc.  Colesevelam Hydrochloride Tablets, 625 mg, are indicated as an adjunct to diet and exercise to:  Reduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia. Reduce LDL-C levels in boys and postmenarchal girls, 10 to 17 years of age, with heterozygous familial hypercholesterolemia (HeFH). Colesevelam Hydrochloride Tablets (RLD: Welchol®) had an annual sales of approximately $159 million in the US (IQVIA MAT September 2020). ]]> <![CDATA[Clarivate reveals India’s position as regional research & innovation hub]]> https://biospectrumindia.com/news/95/17810/clarivate-reveals-indias-position-as-regional-research-innovation-hub.html https://biospectrumindia.com/news/95/17810/clarivate-reveals-indias-position-as-regional-research-innovation-hub.html Fri, 18 Dec 2020 17:55:00 +0530 Clarivate Plc, a global leader in providing trusted information and insights to accelerate the pace of innovation, has announced the release of a new report on Innovation in South and South-East Asia. The report Innovation in South and South-East Asia revealed that 64% of the 235 leading innovators are Indian organisations, reinforcing India’s position as a regional research and innovation hub. Governments and academic institutions in the region are pivotal to enabling innovation. They constitute 57% of the top innovators in the report. Science, technology and innovation are at the forefront of South and South-East Asian countries’ national agendas. The Association of South-East Asian Nations (ASEAN) Plan of Action on Science, Technology and Innovation (2016 to 2025) and ASEAN IPR Action Plan (2016 to 2025) show why and how science, technology and intellectual property (IP) can contribute to national and regional socio-economic development goals. At a national level, the Indian government has identified innovation as a priority, with initiatives such as Innovate India, a platform for showcasing innovation. The concerted policy push by governments and new initiatives from IP offices in the region to encourage IP investment and make IP protection more affordable are encouraging a culture of innovation and IP. South and South-East Asian innovators identified in the report saw their inventions rise by 10% year on year between 2014 and 2018. Jeff Roy, President, IP Group, Clarivate, said, “South and South-East Asia are of the most dynamic and diverse regions in the world and innovation is key to their future growth.” ]]> <![CDATA[Natco launches anticoagulant tablet Rivaroxaban in India]]> https://biospectrumindia.com/news/95/17808/natco-launches-anticoagulant-tablet-rivaroxaban-in-india.html https://biospectrumindia.com/news/95/17808/natco-launches-anticoagulant-tablet-rivaroxaban-in-india.html Fri, 18 Dec 2020 16:20:00 +0530 Natco Pharma Limited has announced the launch of Rivaroxaban molecule, under brand RPIGAT. Rivaroxaban is an anticoagulant medication used to treat and prevent blood clots. Rivaroxaban is currently sold by Bayer under brand name of Xarelto®, in the Indian market. After successful previous launches of DABIGAT (Dabigatran) and AP IGAT (Apixaban) by NATCO, this latest Rivaroxaban NOAC (Novel oral anti-coagulant) is in line with the Company’s mission of affordable medicines accessible to all. NATCO has launched RPIGAT in four strengths- 20 mg, 15 mg, 10 mg and 2.5 mg. The 20 mg strength is priced at an MRP of Rs 14.0 per tablet. ]]> <![CDATA[Sai Life Sciences to recruit over 500 scientists in 2021]]> https://biospectrumindia.com/news/95/17799/sai-life-sciences-to-recruit-over-500-scientists-in-2021.html https://biospectrumindia.com/news/95/17799/sai-life-sciences-to-recruit-over-500-scientists-in-2021.html Fri, 18 Dec 2020 00:00:00 +0530 Hyderabad based Sai Life Sciences, one of India's fastest growing Contract Research, Development & Manufacturing Organisations (CRDMOs), has announced its plans to recruit over 500 scientists during the year 2021. As the first phase of this drive, the company has initiated recruitment for scientific talent in API process and analytical research & development, particle engineering and sciences, niche platform technologies as well as life cycle management. Making the announcement, Krishna Kanumuri, CEO & Managing Director, Sai Life Sciences, said, "Over the past 18-24 months we have been significantly augmenting our R&D facilities and rapidly growing our customer outreach. We expect these efforts to bear fruit in the coming months and are therefore looking to expand our team. This addition to our high-quality talent pool will help us better serve our customers by accelerating their projects involving complex chemistry and next generation technologies.” As part of the current recruitment drive, the company is looking to on-board top-notch global scientific talent with MSc/ PhD / Post Doctorates in synthetic organic / analytical chemistry from reputed academic institutions, and experience in global pharma R&D of up to 20 years, across various levels. The company also has positions open for Technology Transfer focused Process Engineers and Project Managers. Marking the completion of 20 years since its inception in 2019, the company announced Sai Nxt, an organisation-wide initiative aimed at transforming itself into a new generation CRO/CDMO. Guided by the insights and feedback from its customers, it committed to investing over $150M between 2019 and 2023 to significantly expand and upgrade its R&D and manufacturing facilities, deepen scientific & technological capabilities, strengthen automation and data systems, and above all raise the bar for safety, quality and customer focus. As part of Sai Nxt, the company has added 172 KL API & Intermediate manufacturing capacity, opened a discovery biology Lab in Cambridge, Massachusetts, US, a centre of excellence in process R&D in Manchester, UK and an 83,000 sq ft integrated research & technology facility in Hyderabad with technology platforms including flow chemistry, biocatalysis and crystallisation. It became the first India-headquartered company to join Pharmaceutical Supply Chain Initiative (PSCI). The company is now in the process of adding high potent capability in R&D and manufacturing, a new clean room block and 200KL additional manufacturing capacity. ]]> <![CDATA[HCP Wellness expands its oral care, skin care cosmetics plants to Ahmedabad ]]> https://biospectrumindia.com/news/95/17797/hcp-wellness-expands-its-oral-care-skin-care-cosmetics-plants-to-ahmedabad-.html https://biospectrumindia.com/news/95/17797/hcp-wellness-expands-its-oral-care-skin-care-cosmetics-plants-to-ahmedabad-.html Thu, 17 Dec 2020 14:25:00 +0530 Gujarat-based HCP Wellness has recently expanded its range with high-quality oral care, hair care, body care, beauty, and skincare gaining the same overwhelming appreciation from their client and consumer-base. These products now also include soaps, toothpaste, shampoo, cream, body lotion, serums, essential oils, and baby care products. To make the range even more comprehensive, they have further added Ayurvedic supplements, as well as capsules and oral syrups.   Over the past few years, HCP Wellness has managed to create an astonishing client portfolio from start-up to multi-nationals, by aiding them with ideation, R&D support, execution, as well as, the final shelf product. Well-equipped with advanced infrastructure to cater seamlessly all private as well as third party contract manufacturing demands, HCP Wellness has raised the overall expectation bar in the industry. Back in 2006, HCP Wellness started its journey with herbal noni juice, along with a now-famous Ayurveda skincare range. These products started getting a lot of consumer attention for their high product quality and aesthetic packaging. Steadily, this wildfire of praise brought many private label and contract manufacturing inquiries to them, especially for their skincare and herbal cosmetics range, produced using supreme infrastructure. HCP planned to expand its manufacturing infrastructure in 60,000 sq. ft to support higher production demand, by taking every possible contingency in consideration. HCP has designed this manufacturing place with advanced technology, complete with a high-tech R&D laboratory and machinery.  With the expansion of manufacturing units in Ahmedabad, HCP Wellness will able to cater more products and services to its passionate brand's partners through their new unit expectedly from April 2021.   ]]> <![CDATA[UniMask launches new range of cotton masks for Christmas]]> https://biospectrumindia.com/news/95/17795/unimask-launches-new-range-of-cotton-masks-for-christmas.html https://biospectrumindia.com/news/95/17795/unimask-launches-new-range-of-cotton-masks-for-christmas.html Thu, 17 Dec 2020 12:10:00 +0530 Ahead of the festive season, UniMask – A leading brand of face masks amped up its portfolio and launched a new range of cotton masks specially crafted for Christmas. Designed in quirky prints, these cotton blend festive masks are made with ultra soft & comfortable fabric that offers double layered protection and are breathable. The offered range of Christmas masks are available in attractive designs, colour combinations and prints unlike the usually available monotonous black, grey or white masks. These masks offer double layer protection and are made using high quality fabric which is not just soft on the skin but also breathable, making it comfortable to wear all day long.  Available in the Pack of 4 (2 Kids & 2 Adults) priced at Rs 399, Pack of 4 (4 Adults) at Rs 399, Pack of 6 (6 Adult) for Rs 579 and Pack of 10 (10 Adult) for Rs 899. You can buy these highly safe and stylish masks on Amazon, Flipkart and UniMask Official website. Kapil Bhatia, CEO, UniMask speaking on the launch of the new line-up said, “This year festive season is different since the whole world is going through a difficult phase. From the need of the hour give your family, friends and even yourself a gift of safety from the house of UniMask.” ]]> <![CDATA[Neuberg Diagnostics to invest upto Rs 150 crore for expansion in North & East]]> https://biospectrumindia.com/news/95/17791/neuberg-diagnostics-to-invest-upto-rs-150-crore-for-expansion-in-north-east.html https://biospectrumindia.com/news/95/17791/neuberg-diagnostics-to-invest-upto-rs-150-crore-for-expansion-in-north-east.html Wed, 16 Dec 2020 17:00:00 +0530 Chennai based Neuberg Diagnostics has announced its expansion plans in Delhi and Kolkata in Q4FY21. Dr Amrita Singh, an experienced industry expert, has been appointed as Chief of Lab Services for the region. She will be overseeing the company’s expansion and technical operations in North and East India. For expansion in these two regions, the company plans to invest upto Rs 150 crore for organic and inorganic business growth. The company aims to add another 10 labs in the next quarter and 30 labs by end of next fiscal. It also plans to commence commercial operations in the US in next quarter. Dr GSK Velu, Chairman and Managing Director, Neuberg Diagnostics said, “With a commitment to provide affordable diagnostics, we are now rolling out our quality routine and referral lab testing services in North & East India. Additionally, we are aiming to launch new generation techniques that are deployed for diagnosing complicated diseases where deeper analysis is required. “South and West have been our focus markets over the past three years. We are already leaders in markets like Karnataka, Gujarat, Tamil Nadu, Kerala and South Maharashtra, and are expanding our presence in other key markets like Andhra Pradesh & Telangana and Mumbai in Maharashtra by next quarter. Now we want to be a significant player in North and East. In both the regions, we are looking for organic and inorganic growth catering to the testing needs,” added Dr Velu. A Ganesan, Vice Chairman, Neuberg Diagnostics said, “Currently, through hospital lab management and customer walk-in centres, we already have a presence in Delhi NCR and Chandigarh. Bringing on board Dr Amrita Singh and a senior leadership team based in Delhi and Kolkata will provide the necessary management bandwidth and technical expertise to grow our operations in North and East India over the next two years. Our northern growth will be similar to South and West India, which has enabled us to become one of the top 4 diagnostics path lab players within 3 years of our operations, since Oct 2017.” ]]> <![CDATA[DetelPro unveils voice-enabled BP monitoring machine ]]> https://biospectrumindia.com/news/95/17788/detelpro-unveils-voice-enabled-bp-monitoring-machine-.html https://biospectrumindia.com/news/95/17788/detelpro-unveils-voice-enabled-bp-monitoring-machine-.html Wed, 16 Dec 2020 13:50:00 +0530 DetelPro, the health and hygiene vertical of Detel India has launched a new digital monitoring solution- Blood Pressure Monitoring machine (Di-BP01) in its medical portfolio. Priced at Rs 1499, this BP device is available for purchase on Detel’s website. DetelPro BP device is equipped with voice technology that enables people to hear their blood pressure reading. It also has an arrhythmia indicator that alerts the user of irregular heartbeat. This professional-grade device features 99 sets of storage for two people at a time and comes with an adjustable large arm cuff that fits arm circumference. Powered by DC 6V (1.5V Four AAA Batteries), this digital blood pressure monitor can also be powered using a USB charging port. The product comes with 2 years of warranty and meets the requirements for both accuracy and cost-efficiency. Early this year, DetelPro has Launched the World’s Most Economical 'Make In Bharat' Infrared Thermometer at Just Rs 999. The company has a pipeline of new products to launch in the coming months and will continue to broaden its portfolio across the appliance category in the country.   ]]> <![CDATA[Biocon Biologics signs MoU with Tanzania for affordable access to quality insulins]]> https://biospectrumindia.com/news/95/17785/biocon-biologics-signs-mou-with-tanzania-for-affordable-access-to-quality-insulins.html https://biospectrumindia.com/news/95/17785/biocon-biologics-signs-mou-with-tanzania-for-affordable-access-to-quality-insulins.html Wed, 16 Dec 2020 12:55:00 +0530 Biocon Biologics Ltd, a fully integrated ‘pure play’ biosimilars company and a subsidiary of Biocon Ltd in continuation of its Mission 10 cents affordable insulins programme for low- and middle-income countries (LMICs), has signed a Memorandum of Understanding (MoU) with the Christian Social Services Commission (CSSC), a faith-based organisation active in Africa. CSSC works closely with the government as well as international and national partners to facilitate health and education services. Tanzania will be the first country in Africa that will benefit from this collaboration between Biocon Biologics and CSSC. As a leading global insulins player, Biocon Biologics is helping unlock universal access to quality insulins in low- and middle-income countries (LMICs) by making recombinant human insulin (rh-insulin) available for less than $0.10 per day as a part of its ‘Mission 10 cents’ programme. Besides improving access to insulin treatment by making affordable yet high quality insulin available, Biocon Biologics is working with local partners to help strengthen overall healthcare capacity with the aim of supporting all people with diabetes in LMICs, where diabetes prevalence has been rising more rapidly than in high-income countries. Tanzania is among the top 5 countries for the number of people with diabetes in Africa. An estimated 19.4 million adults aged 20-79 years were living with diabetes in the IDF Africa Region in 2019, representing a regional prevalence of ~4%. Dr Christiane Hamacher, CEO & Managing Director, Biocon Biologics, said: “We aspire to co-create with our partner a patient ecosystem that goes beyond the product to transform the lives of millions of diabetes patients globally.” Dr Alexander Zach, Global Head of Market Access & Policy, Biocon Biologics, said, “Our vision is to build a long-term, integrated disease management ecosystem that enables affordable diabetes management and better patient outcomes in Tanzania through our partner to expand the reach of our ‘Mission 10 cents’ programme.” Peter Maduki, CEO, CSSC, said, “CSSC will use its newly established pharmaceutical company Mission for Essential Medical Supplies (MEMS) to supply the recombinant human insulin (rh-insulin) to both Faith based, private and public health facilities across the whole country.” The programme is expected to roll-out early next year and will include community-based health promotion, disease awareness campaigns, screening programmes, capacity building of health facilities and training of healthcare professionals. ]]> <![CDATA[LogiNext brings COVID-19 vaccine supply chain management platform]]> https://biospectrumindia.com/news/95/17782/loginext-brings-covid-19-vaccine-supply-chain-management-platform.html https://biospectrumindia.com/news/95/17782/loginext-brings-covid-19-vaccine-supply-chain-management-platform.html Wed, 16 Dec 2020 10:15:00 +0530 LogiNext has announced the launch of a COVID -19 vaccine supply chain management and tracking platform. With several parts of the globe in the grips of a second or third wave of the COVID-19 pandemic, vaccine trials are on and a reliable supply chain mechanism for the vaccine distribution is the need of the hour. Building the digital backbone for a global logistics movement, Mumbai based LogiNext has been at the forefront of the automation technology revolution. During the nascent phases of the pandemic, LogiNext proactively started working on a solution which is now available for government and healthcare organisations. Dhruvil Sanghvi, Chief Executive Officer, LogiNext said, "We have been working hard for a while now on this vaccine tracking solution including some key features for the cold chain. We’re very proud to launch the first solution to manage a complex supply chain around COVID-19 vaccine from manufacturing facilities all the way till the last mile.” LogiNext Mile is a complete all-mile transportation automation platform which can be used for tech-enabled management of vaccine distribution. The SaaS platform can be deployed for complete visibility and tracking of the vaccine distribution right from the point of origin at the manufacturing units to the last mile. The solution can be used for the entire chain or a part of the solution can be used for: Visibility and tracking: LogiNext Mile gives a real-time dashboard via which managers can keep track of all logistical movement and orchestrate a distribution plan. Demand forecasting and Order scheduling: Operators now have the capability to accurately forecast the needs across the globe according to which orders on the first mile can be triggered. Detailed analytics: LogiNext’s expertise in artificial intelligence and machine learning capabilities gives its clients (healthcare enterprises, governmental organisations, carriers and 3PLs) an added advantage in the form of detailed and accurate analytics on all the legs of the supply chain. “Talks are ongoing for pilots with several organisations and our team of experienced engineers have worked round the clock to get the best-in-class solution available. We’re extremely proud of what the team has been able to achieve and it is proof for how technology can be used for good,” said Manisha Raisinghani, CTO, LogiNext.   ]]> <![CDATA[Serum Institute announces first-in-human trial of COVI-VAC]]> https://biospectrumindia.com/news/95/17781/serum-institute-announces-first-in-human-trial-of-covi-vac.html https://biospectrumindia.com/news/95/17781/serum-institute-announces-first-in-human-trial-of-covi-vac.html Tue, 15 Dec 2020 18:20:00 +0530 US-based Codagenix and Serum Institute of India Pvt. Ltd. have announced that a Phase 1 clinical trial of COVI-VAC received regulatory approval by the Medicines and Healthcare Products Regulatory Agency (MHRA) and has commenced in London, UK. COVI-VAC is a single-dose intranasal, live attenuated vaccine against SARS-CoV-2, the virus that causes COVID-19, that was shown to be safe and efficacious in preclinical animal studies. COVI-VAC was developed with Codagenix's Synthetic Attenuated Virus Engineering (SAVE) platform that uses synthetic biology to re-code the genes of viruses into safe and stable vaccines. COVI-VAC is designed to deliver a safe, live attenuated version of SARS-CoV-2 that may induce a more robust immune response and long-lasting cellular immunity against SARS-CoV-2 compared to other vaccines against the virus. COVI-VAC has the potential to address several key logistical challenges to immunization against SARS-CoV-2 at a global scale.  As a single-dose, intranasally-delivered vaccine, COVI-VAC will not require a needle and syringe, nor ultra-low temperature freezers. COVI-VAC can be manufactured at large scale and supports ease of administration in a mass vaccination campaign. The Phase 1 trial of COVI-VAC is designed as a randomized, double-blind, placebo-controlled, dose-escalation study to evaluate the safety and tolerability of a single dose of COVI-VAC administered by nose drops. The secondary objective of the study is to evaluate immunogenicity, or the vaccine's ability to provoke an immune response, measured as neutralizing antibody, mucosal IgA and cellular immune responses. The trial will be conducted by hVIVO in London, UK, a subsidiary of Open Orphan. Patient recruitment has begun and dosing of the first trial participants will commence in the first week of January 2021. With the Phase 1 trial now initiated, Codagenix and Serum Institute of India expect to begin advanced clinical testing in mid-2021.   "We at SIIPL are pleased with the MHRA approval for initiating the first-in-human clinical trial for the novel intranasal product against COVID-19, developed by Codagenix in collaboration with SIIPL. The product is promising with many unique features and will make our fight against the virus stronger, and therefore, this news is surely welcoming," said Dr. Rajeev Dhere, Executive Director of SIIPL.   ]]> <![CDATA[HiGenoMB gets ICMR, CE/IVD approval for its COVID range of products]]> https://biospectrumindia.com/news/95/17773/higenomb-gets-icmr-ce-ivd-approval-for-its-covid-range-of-products.html https://biospectrumindia.com/news/95/17773/higenomb-gets-icmr-ce-ivd-approval-for-its-covid-range-of-products.html Mon, 14 Dec 2020 17:20:00 +0530 HiGenoMB®, the Molecular Biology Division of HiMedia Laboratories Pvt Ltd the leading Indian BioSciences manufacturer proudly announces that it has received the prestigious ICMR and CE/IVD approval for its COVID Range of Products. HiMedia Laboratories has also successfully launched the InstaNX® Mag Series of Automated DNA/RNA Extraction Platforms viz InstaNX®Mag32 capable of processing 32 samples & InstaNX®Mag96, the high throughput version capable of processing 96 samples. Hi-PCR® Coronavirus (COVID-19) Multiplex Probe PCR Kits (MBPCR243) is a RT-PCR Kit capable of detecting 4 different genes- N gene, E gene, RdRp gene and RPPH1 (Endogenous Internal Control) in the same assay. HiPurA® Viral RNA Purification Kit (MB615) - Manual Spin Column based kit has been the front runner amongst the COVID products for HiGenoMB®. HiMedia ensured timely and continuous supply of Manual Viral RNA Extraction Kits across the country during the initial stages of the pandemic making it the most sought after Indian manufacturer capable of meeting the demands of the COVID Diagnostic market. HiPurA® Viral RNA Purification Kit – Magnetic Bead Based (MB615M) was approved from ICMR-approved site NIV (Pune) along with its use with HiMedia’s Automated DNA/RNA Instrument- InstaNX Mag96. Dr Rajas Warke, Director, HiMedia’s Molecular Biology Division says ”During the initial days into the COVID-19 pandemic with very few signs being observed globally, we re-directed the R&D team towards development of COVID-19 molecular diagnostic products. The ICMR validation thus makes HiMedia synonymous with being a Complete Solution Provider for COVID Molecular Detection and being the Only Indian manufacturer in this capability.” “HiGenoMB® and team HiMedia, is proud to have introduced effective COVID products under the most challenging working conditions. Despite HiMedia’s research scientists also being affected by COVID-19, the rest of the team immediately stepped up the momentum to deliver COVID-19 related products successfully to our nation.” added Dr Kavita Khadke, Director, HiMedia’s Molecular Biology. ]]> <![CDATA[OSIF inks licence agreement with Biological E for COVID-19 vaccine technology]]> https://biospectrumindia.com/news/95/17763/osif-inks-licence-agreement-with-biological-e-for-covid-19-vaccine-technology.html https://biospectrumindia.com/news/95/17763/osif-inks-licence-agreement-with-biological-e-for-covid-19-vaccine-technology.html Mon, 14 Dec 2020 00:00:00 +0530 Biological E Limited (BE), a Hyderabad-based vaccine & pharmaceutical company, and the Ohio State Innovation Foundation (OSIF), US announced the execution of an exclusive license agreement for a COVID-19 vaccine technology. OSIF has licensed novel live attenuated measles virus vectored vaccine candidates against SARS-CoV-2, which were developed by the Ohio State University College of Veterinary Medicine, exclusively to (BE). BE will be responsible for the evaluation and further development, including the commercialisation of the vaccine candidate(s). The licensed intellectual assets were developed in the laboratories of Jianrong Li, DVM, PhD, and Stefan Niewiesk, DVM, PhD, as a response to the global pandemic. The vaccine candidates are live attenuated recombinant viral vectored vaccines based on measles vaccine strains. “Translating this vaccine platform into the hands of a global vaccine company for further evaluation and development is a critical step and we are excited that Biological E has taken on this role,” said Dr Patrick Green, Associate Dean, Research and Graduate Studies, Ohio State University College of Veterinary Medicine. The Ohio State University College of Veterinary Medicine (CVM) team’s approach utilises the SARS-CoV-2 spike (S) protein as a target protein for SARS-CoV-2 vaccine candidates, generating a series of attenuated recombinant measles viruses (rMeVs) expressing SARS-CoV-2 antigens. All resultant rMeVs, the basis for the vaccine candidates, grow to high virus titer in Vero cells, a WHO-approved cell line for vaccine production. They were also shown to express the recombinant S antigens, a critical step in developing a SARS-CoV-2 vaccine. The rMeV-based SARs-CoV-2 vaccine candidates have proceeded through proof-of-concept trials in multiple animal models – demonstrating successful production of SARS-CoV-2 antibodies. “BE has been working to develop a safe and effective vaccine for the COVID-19. BE is very happy to help further this innovation and expand that effort,’’ said Mahima Datla, Managing Director, Biological E Limited. “With this licensing transaction, we have expanded the repertoire of the candidate vaccine(s) that we are evaluating, both in terms of the antigen and the platform technology,” said Narender Dev Mantena, Director, BioE Holdings Inc, who heads BE’s novel vaccine initiative. ]]> <![CDATA[WHO pre-qualifies Biological E’s typhoid conjugate vaccine]]> https://biospectrumindia.com/news/95/17764/who-pre-qualifies-biological-es-typhoid-conjugate-vaccine.html https://biospectrumindia.com/news/95/17764/who-pre-qualifies-biological-es-typhoid-conjugate-vaccine.html Fri, 11 Dec 2020 18:10:00 +0530 Biological E Limited (BE), a Hyderabad-based vaccines and pharmaceutical company, has announced that its Typhoid Conjugate Vaccine (TCV) has been pre-qualified by the World Health Organisation (WHO). With this pre-qualification, BE became one of two pre-qualified suppliers of TCV to the UN agencies. BE’s TCV is a single-dose injectable vaccine, which can be administered to children from 6 months of age to adults up to the age of 45 and it is formulated with Vi polysaccharide conjugated to a carrier protein (CRM197). The Vi polysaccharide antigen used in BE’s TCV is derived from C freundii, which is a non-pathogenic source (BSL 1 organism), compared to virulent Salmonella Typhi used by other manufacturers, and the carrier protein used for conjugation is a non-toxic CRM197 protein locally developed by BE through in-house R&D effort. Clinical studies conducted in India have shown that the safety and immunogenicity profiles of this vaccine are comparable with those of the other WHO pre-qualified TCV. The vaccine was developed in collaboration with the GSK Vaccines Institute for Global Health (GVGH), based in Siena, Italy, which first developed the vaccine strain and transferred the technology to BE in 2013. BE has further developed the vaccine, including manufacturing process optimisation and scale up, pre-clinical studies and comprehensive clinical trials for Phase I, II/III in India. Today, this vaccine is being manufactured in BE’s GMP manufacturing facilities in Hyderabad, India. “We believe that every year this vaccine would save about 1.5 lakh people worldwide,” said Mahima Datla, Managing Director, Biological E Limited. Francesco Berlanda-Scorza, Director, GVGH said, “For more than a decade, GVGH has been advancing vaccines for under-recognised diseases, and as a result of an innovative partnership with Biological E to develop this vaccine, and TCV pre-qualification by WHO, many more children will have access to a much needed intervention for prevention of typhoid fever.” In March 2020, BE received approval from India's health regulators to authorise and market a new TCV (BE’s product TYPHIBEV) for infants, children and adults from 6 months. ]]> <![CDATA[SpiceJet partners with Om Logistics for seamless delivery of COVID-19 vaccine]]> https://biospectrumindia.com/news/95/17758/spicejet-partners-with-om-logistics-for-seamless-delivery-of-covid-19-vaccine.html https://biospectrumindia.com/news/95/17758/spicejet-partners-with-om-logistics-for-seamless-delivery-of-covid-19-vaccine.html Fri, 11 Dec 2020 12:25:00 +0530 SpiceJet, in its endeavour to provide seamless end-to-end cold chain solutions for COVID-19 vaccine delivery, has partnered with Om Logistics Limited, one of the largest logistics companies in India. The two Companies have joined hands with the intent to effectively carry out the herculean task of transporting temperature-sensitive COVID–19 vaccine. This strategic partnership aims to not only provide a speedy, seamless and reliable solution for COVID-19 vaccine movement and delivery but, to also create a sustainable cold chain network both, domestically and internationally. As a part of the association, Om Logistics Ltd will provide SpiceJet with the refrigerated trucks to cover the first mile and the last mile across length and breadth of the country. SpiceJet will provide the necessary air support to carry COVID–19 vaccines pan India and internationally in a temperature controlled environment. With a network spanning 54 domestic and 45 international destinations and a fleet of 17 cargo planes, SpiceXpress is capable of flying over 500 tonnes of cargo per day to both domestic and a wide list of international destinations. The airline has also tied up with global leaders in cold chain solutions offering active and passive packaging with dedicated equipment to perform seamless cold chain operations and is ready for the enormous task of distributing sensitive goods both domestically and internationally including COVID-19 vaccines that require stringent transportation conditions. Om Logistics Ltd’s international presence with its 1,200 offices world-wide and ability to cater to more than 19,000 pin codes in India will further boost SpiceJet’s strength. Ever since the lockdown began, SpiceJet and its cargo arm, SpiceXpress, have played a critical role and worked relentlessly to ensure that the country’s supply chain remained intact. The airline has helped in the transportation of vital goods and medical supplies to all corners of India and the world. SpiceXpress recently introduced a new specialised service called Spice Pharma Pro, which has the capability to transport extremely sensitive drugs, vaccines blood samples and medicines in controlled temperatures ranging from -40°C to +25°C. ]]> <![CDATA[70 Ambassadors, High Commissioners visit Bharat Biotech to discuss COVAXIN]]> https://biospectrumindia.com/news/95/17755/70-ambassadors-high-commissioners-visit-bharat-biotech-to-discuss-covaxin.html https://biospectrumindia.com/news/95/17755/70-ambassadors-high-commissioners-visit-bharat-biotech-to-discuss-covaxin.html Thu, 10 Dec 2020 18:25:00 +0530 A team of 70 Ambassadors and High Commissioners from several nations visited the Bharat Biotech facility at Genome Valley, Hyderabad on 9 December to learn more about their work to establish a safe and efficacious vaccine against COVID-19.   The delegation led by the Ministry of External Affairs comprised of High Commissioners and Government representatives of 70 countries across the world from Asia, Africa, Europe, North America, South America, and Oceania.     The delegation was briefed about Bharat Biotech’s vaccine development programme by Dr Krishna Ella, Chairman and Managing Director, spearheading the COVAXIN™️ research, development, clinical trials and production teams. The delegates were presented Bharat Biotech’s research process, manufacturing capabilities, expertise, given virtual and physical tours of the facilities. The envoys voiced their appreciation of Bharat Biotech work of national and global public health significance, working very hard for several months to establish a long-lasting efficacious vaccine to combat the extraordinary COVID-19, pandemic. The indigenous, inactivated vaccine is developed and manufactured in Bharat Biotech's BSL-3 (Bio-Safety Level 3) bio-containment facility. COVAXIN™️ is a highly purified and inactivated 2 dose SARS-CoV2 vaccine, manufactured in a vero cell manufacturing platform with an excellent safety track record of more than 300 million doses. COVAXIN™️ has been evaluated in approximately 1000 subjects in Phase I and Phase II clinical trials, with promising safety and immunogenicity results. The Phase III human clinical trials of COVAXIN™️ began in November, involving 26,000 volunteers across India. This is India’s first and only Phase III efficacy study for a COVID-19 vaccine, and the largest phase III efficacy trial ever conducted for any vaccine in India. Speaking on the occasion, Suchitra Ella, Joint Managing Director, Bharat Biotech added, “The development and clinical evaluation of COVAXIN™️ marks a significant milestone for novel vaccinology in India. COVAXIN™️ has garnered interest from several countries worldwide for supplies and introduction. It is an honour to have with us today all the distinguished ambassadors of various countries. It makes us proud to note that the world is looking up to India in the common fight against this deadly pandemic.” ]]> <![CDATA[Nua launches first-of-its-kind product to help with period pain]]> https://biospectrumindia.com/news/95/17741/nua-launches-first-of-its-kind-product-to-help-with-period-pain.html https://biospectrumindia.com/news/95/17741/nua-launches-first-of-its-kind-product-to-help-with-period-pain.html Wed, 09 Dec 2020 17:25:00 +0530 Period cramps affect close to 70 percent of menstruating women in India and can cause troubled sleep, erratic mood swings, often leaving women irate and feeling fatigued. To offer relief from period pain, women’s wellness brand Nua has launched an innovative self-heating patch uniquely designed to provide up to 8 hours of heat. Cramp Comfort, crafted after in-depth research and a profound understanding of consumer needs, is made entirely of natural ingredients. A pack of three heat patches is available at a cost-effective price range of Rs 299. Built on the principle of heat therapy that works by relaxing the muscles of the uterus and thereby increasing blood flow and easing pain, Cramp Comfort is convenient, lightweight, hands-free solution and a game-changer shift from the traditional hot water bag. These patches adhere to strict safety norms and regulate the temperature to a degree that is beautifully warm but not overly hot and hug a woman’s body to provide maximum relief. The patches are made of natural ingredients and can be used as fertilizers for potted plants during disposal. Mumbai based Nua is a new-age brand transforming the women's wellness space in India with holistic and personalized solutions that address real problems faced by women in managing their menstrual health and personal hygiene. Nua has developed an innovative range of products and services that include India's first customizable pack of sanitary pads and self-heating menstrual cramp patches. ]]> <![CDATA[Sodexo India unveils first bio-medical equipment mobile app]]> https://biospectrumindia.com/news/95/17739/sodexo-india-unveils-first-bio-medical-equipment-mobile-app.html https://biospectrumindia.com/news/95/17739/sodexo-india-unveils-first-bio-medical-equipment-mobile-app.html Wed, 09 Dec 2020 17:10:00 +0530 Sodexo India has introduced a path-breaking initiative -Sodexo Healthcare Technology Management (HTM), a mobile-app based service which will provide maintenance services for biomedical equipment and its life cycle management in partnership with Association of Healthcare Providers (India). The service is aimed at offering relief to the overburdened small and medium healthcare facilities, diagnostic centers, and laboratories, which are heavily dependent on Original Equipment Manufacturers (OEMs) for asset management services in the absence of a dedicated in-house team of professionals. Sodexo HTM makes available professional technical help at an affordable price within a response time of 24 hours. Launched in phase 1 in West Bengal, the expansion plan includes other regions like Northeast, Orissa, and rest of India by the end of the next fiscal year. Backed by nearly two decades of global expertise in managing medical equipment lifecycle, Sodexo India forayed into this field in 2017. Sodexo was awarded the contract for the Presidency division of West Bengal state, covering 6 District Hospitals, 8 Healthcare Districts, 10 Medical Colleges & Hospitals and 464 Healthcare Facilities. Today, with a team of 150+ biomedical engineers, Sodexo is overlooking asset tagging, user training, breakdown & preventive maintenance, calibration, installation and relocation of 60,000+ medical types of equipment for which, the company is ISO 13485: 2016 certified. Speaking at the launch event, Sambit Sahu – Segment Director, Sodexo Healthcare, India stated, “The changing medical technology landscape, improving healthcare delivery and strong competition from the large private sector healthcare providers has led to a rise in patient expectations. With Sodexo HTM, we are providing leverage to the small hospitals and diagnostics centres with our maintenance services that are real-time, competitive, and world-class, helping them focus on their core jobs. A well-trained team of engineers and a fully equipped lab with 3000+ spares and accessories will ensure impeccable repairs and maintenance of the medical equipment in West Bengal region”. ]]> <![CDATA[KARAM expands healthcare range to combat COVID-19]]> https://biospectrumindia.com/news/95/17734/karam-expands-healthcare-range-to-combat-covid-19.html https://biospectrumindia.com/news/95/17734/karam-expands-healthcare-range-to-combat-covid-19.html Tue, 08 Dec 2020 17:30:00 +0530 The ongoing novel coronavirus disease (COVID-19) pandemic has already impacted millions worldwide and with no vaccine available as of now, interventions to mitigate transmission has been the only way to control the pandemic. In its commitment to fight the spread of COVID-19 by supporting the healthcare workers and consumers in India and worldwide, KARAM – India’s leading Personal Protective Equipment (PPE) manufacturing company – has announced its expansion in the consumer healthcare segment today with the launch of its KARAM Plus range. With the launch, the company is expanding its medical, healthcare PPE product portfolio and expanding healthcare range in response to the number of cases getting reported. The latest product range under KARAM Healthcare include RF 101 – RFH 101 K-Air N 95 disposable face masks, with an aim to serve its customers in the healthcare sector to offer quality, comfort and affordability. Developed with certified US National Institute and Occupational Safety and Health (NIOSH) standards, the K-Air range has been designed to offer maximum protection to healthcare workers and consumers at large with comfort for prolonged usage. Announcing the new product range, Hemant Sapra, President, Global Marketing, KARAM Industries said, “As the COVID-19 pandemic accelerates, it is of utmost importance to safeguard medical fraternity and our consumers given that our fight against the pandemic is here to stay for a while. The launch of KARAM Healthcare range is yet another step in this vein and our humble effort in making India’s healthcare ecosystem Atmanirbhar (self-reliant).” The company has taken several initiatives to provide support to the frontline workers through safety products amid the ongoing situation. Earlier this year, the company was given Government’s sanction to manufacture protective goggles for doctors and the police workforce across the country and also started manufacturing medical face shields in order to fight the global pandemic. KARAM also initiated a safety awareness drive to highlight the threats being faced by healthcare workers every day. ]]> <![CDATA[Max Life launches critical illness and disability rider]]> https://biospectrumindia.com/news/95/17732/max-life-launches-critical-illness-and-disability-rider.html https://biospectrumindia.com/news/95/17732/max-life-launches-critical-illness-and-disability-rider.html Tue, 08 Dec 2020 16:45:00 +0530 Max Life Insurance Company Ltd has announced the launch of ‘Max Life Critical Illness and Disability Rider’ and with it, the launch of ‘Max Fit’, a comprehensive wellness programme. Max Fit is a wellness app designed to lead customers on a path of protection through holistic fitness and wellness. In line with the company’s brand philosophy of ‘#YouAreTheDifference’, the app promises to provide patrons with a unique and exciting opportunity to work towards a healthier lifestyle with the ultimate aim of helping them realise that their health is their biggest asset. Max Life’s newly launched ‘Max Life Critical Illness and Disability Rider’ provides comprehensive financial protection against a range of critical illnesses and disability. With many critical illnesses linked to lifestyle related habits, Max Life wants customers to stay fit, active and maximise their personal health and well-being. Speaking on the launch of the offerings, Prashant Tripathy, Managing Director & CEO, Max Life said, “With the launch of Max Life Critical Illness and Disability Rider, we aim to offer customers protection from any untoward circumstances, while rewarding them for taking care of their personal wellbeing. The accompanying Max Fit marks a great milestone in our digitisation journey to deliver superior customer experience.” ‘Max Life Critical Illness and Disability Rider’ offers customers protection from up to 64 critical illnesses, and has a cover under which one can protect themselves or their loved ones. It also comes with a flexible payment option wherein one can opt for limited pay or regular pay option as per the base plan. The rider can be attached to 11 of Max Life’s existing products ranging from term plans and saving plans to monthly income plans, and more. Available exclusively with the rider, ‘Max Fit Program’ is a wellness app with features such as a wellness assessment score, medicine reminder, daily health tips, digitised access to all health reports and a wellness calculator for illnesses such as diabetes, heart diseases, stress, anxiety, etc. Celebrated tennis player Mahesh Bhupathi whom Max Life has engaged to drive home the message of leading a healthy lifestyle, added, “Max Life is redefining the landscape of new age life insurance solutions. I’m happy to associate with the futuristic vision of the firm and look forward to our journey as we encourage Indians to adopt a physically sound approach to life.” ]]> <![CDATA[Colgate launches zig zag anti-bacterial toothbrush]]> https://biospectrumindia.com/news/95/17726/colgate-launches-zig-zag-anti-bacterial-toothbrush.html https://biospectrumindia.com/news/95/17726/colgate-launches-zig-zag-anti-bacterial-toothbrush.html Mon, 07 Dec 2020 18:45:00 +0530 Colgate-Palmolive (India) Limited, the market leader in oral care in the country, has announced the launch of the all-new Colgate Zig Zag Anti-Bacterial Toothbrush, a first of its kind in the Zig Zag portfolio. The brand has signed the inspirational Ayushmann Khurrana as the brand ambassador for the launch. Equipped with 100% silver-ion anti-bacterial bristles, Colgate India’s latest Zig Zag Anti-Bacterial Toothbrush repels bacteria from the bristle surface by disrupting their ability to form colonies. When toothbrushes are stored, bacteria are known to form colonies and spread diseases by attaching themselves to the toothbrush bristles and eventually ending up in our mouths while brushing. Any disruption in this ability prevents the growth of bacteria and stops the spread of environmental bacteria. In addition, Zig Zag's multi-angled bristles remove germs in between teeth and comes along with a soft tongue cleaner that gently removes odour causing germs for fresher breath. Its flexible handle reduces pressure on the wrist while brushing and softly massages gums, offering superior benefits for overall protection. Commenting on the campaign, Arvind Chintamani, Vice President, Marketing, Colgate-Palmolive (India) Limited, said, “We have introduced advanced silver-ion bristle technology on Colgate Zig Zag Anti-bacterial toothbrush at an affordable price ₹30. You can find this brush now in millions of stores across the country and on e-commerce platforms.”  Decoding the Science behind Colgate India’s latest innovation, Prof Dr Porus S Turner, leading Dental Surgeon and Implantologist said, “There is a great potential to have a proven antibacterial toothbrush worldwide. India has a large population that needs to be made aware of the importance of such sensitive oral health issues that could curb the growth of bacteria causing diseases.” ]]> <![CDATA[Zydus announces Ph 1 trial of novel molecule ZYIL1]]> https://biospectrumindia.com/news/95/17724/zydus-announces-ph-1-trial-of-novel-molecule-zyil1.html https://biospectrumindia.com/news/95/17724/zydus-announces-ph-1-trial-of-novel-molecule-zyil1.html Mon, 07 Dec 2020 18:00:00 +0530 Zydus, a leading discovery based, global pharmaceutical company has announced that it has received permission to initiate the Phase 1 clinical trial of ZYIL1, a novel oral small molecule NLRP3 inhibitor candidate. NLRP3 inflammasomes are involved in the inflammation process by production and release of proinflammatory cytokines IL-1β and IL-18. This harmful inflammation within the body leads to the onset and development of various kinds of diseases, including Acute Respiratory Distress Syndrome (ARDS), auto-immune diseases, inflammatory diseases, cardiovascular diseases, metabolic disorders, Gastro-intestinal diseases (inflammatory bowel disease), renal diseases and CNS diseases. Speaking on the development, Pankaj R Patel, Chairman, Cadila Healthcare Ltd, said, “We will study the safety, tolerability, pharmacokinetics and pharmacodynamics of ZYIL1 in this Phase I clinical trial in healthy human volunteers. We are committed to developing these pioneering novel treatments to the clinic for the patients in need.”   ]]> <![CDATA[Zydus Cadila receives DCGI approval for Ph 3 trial of biological therapy in COVID-19 patients]]> https://biospectrumindia.com/news/95/17713/zydus-cadila-receives-dcgi-approval-for-ph-3-trial-of-biological-therapy-in-covid-19-patients.html https://biospectrumindia.com/news/95/17713/zydus-cadila-receives-dcgi-approval-for-ph-3-trial-of-biological-therapy-in-covid-19-patients.html Fri, 04 Dec 2020 15:50:00 +0530 Zydus Cadila announced that it had received an approval from the Drugs Controller General of India (DCGI) to start the Phase 3 clinical trial in COVID-19 patients with its biological therapy, Pegylated Interferon alpha-2b, ‘PegiHepTM’. The trials which will commence in December will be conducted on 250 patients across 20-25 centres in India. In the Phase II clinical trials study established the early safety, efficacy and tolerability of PegiHep TM and has indicated that Pegylated Interferon alpha-2b having statistical clinical beneficial impact on the patient suffering from moderate COVID-19 disease by reducing their viral load helping in better disease management such as reduced duration of oxygen support. Moreover, a single dose therapy will improve compliance and also make it highly affordable for patients. Pegylated Interferon alpha-2b, ‘PegiHepTM is an approved drug and is being re-purposed for the treatment of COVID-19. Speaking on the development, Dr Sharvil Patel, Managing Director, Cadila Healthcare Ltd, said, “We are encouraged by the results of Phase II study of Pegylated Interferon alpha 2-b which has shown the potential to reduce virus titres when given earlier in the disease.” In the Phase 2 clinical trial which was open-label, randomised, comparator controlled study, involving 40 adult patients with moderate COVID-19 disease, 95 per cent subjects in the test arm who received a single dose of PegiHepTM along with the Standard Of Care (SOC), became virus free as assessed by RT-PCR on day 14 and showed a statistically significant clinical improvement over the patients in the reference arm, who received only the standard of care and where only 68 per cent patients showed an improvement in clinical symptoms and became RT-PCR negative. In the test arm 16 subjects were RT-PCR negative as early as day seven of treatment which was an improvement over the reference arm. Clinical improvement was assessed using a seven point ordinal scale where the patients were assessed on multiple criteria such as requirement and duration of hospitalisation, ventilation, supplemental oxygen etc. Zydus Cadila is also conducting a similar Phase 2 trial in Mexico. The Company is also working with the US FDA to open an Investigational New Drug (IND) application for Pegylated Interferon alpha-2b in order to initiate appropriate clinical trials in US. ]]> <![CDATA[Indifi Technologies forays into pharma segment by joining forces with Marg ERP ]]> https://biospectrumindia.com/news/95/17698/indifi-technologies-forays-into-pharma-segment-by-joining-forces-with-marg-erp.html https://biospectrumindia.com/news/95/17698/indifi-technologies-forays-into-pharma-segment-by-joining-forces-with-marg-erp.html Thu, 03 Dec 2020 00:00:00 +0530 Gurugram based Indifi Technologies has recently forayed into the pharma segment by joining forces with Marg ERP, India’s largest ERP solution provider with over 2.75 Lakh installations and over 1 Million users. Through this association, Indifi will be extending its credit line solution to retailers - especially Pharma Distributors and local chemists - for managing their working capital needs and cash flows using the Margpay platform. The offering comes with easy repayment options and provides a wider access to retailers, including those hailing from Tier 2 and 3 cities. With its new offering, Indifi is not only targeting retailers but also aiming to cater to distributors by offering them loans in the range of Rs 5-25 lakh for efficient working capital management. This makes it a holistic solution for every player within the pharma and FMCG supply chain, providing a boost to their businesses in terms of adequate capital and smooth flow of inventory. The collaboration between the two domain leaders will also digitise the collection and payment journey for distributors and retailers present on Marg’s platform. While distributors can notify retailers to clear their outstanding dues via a completely digital process, retailers can make payments via different modes, including UPI and credit, using the same platform as a one-stop solution. It will also enable both parties to track their receipts and payments, anywhere and anytime, thereby ensuring transparency in their operations. Alok Mittal, CEO & Founder, Indifi said, “Thanks to our new partner, Marg ERP, we will extend our credit services to their huge customer base, accounting to over 2 lakh merchants and distributors, of which 75 per cent are from the pharma segment. Together, not only we will be providing them with adequate credit access to ensure seamless operations, but we will also be driving financial inclusion and encouraging retailers from Tier 2 and 3 cities to go digital in every aspect.” Krishnam Raju, CEO, Marg ERP said, “The platform offers payment solutions, credit, easy reconciliation and many more exciting features. Our 850+ partner network will not only help customers get informed, but also extract the benefits of this credit system further.” ]]> <![CDATA[Dr Reddy’s, RDIF commence ph 2/3 trials in India for Sputnik V vaccine]]> https://biospectrumindia.com/news/95/17693/dr-reddys-rdif-commence-ph-2-3-trials-in-india-for-sputnik-v-vaccine.html https://biospectrumindia.com/news/95/17693/dr-reddys-rdif-commence-ph-2-3-trials-in-india-for-sputnik-v-vaccine.html Wed, 02 Dec 2020 11:25:00 +0530 Dr Reddy’s Laboratories Ltd and Russian Direct Investment Fund (RDIF) announced that they have commenced adaptive phase 2/3 clinical trials for Sputnik V vaccine in India after receiving the necessary clearance from the Central Drugs Laboratory, Kasauli, India. This will be a multi-centre and randomised controlled study, which will include safety and immunogenicity study. The clinical trials are being conducted by JSS Medical Research as the clinical research partner. Further, Dr Reddy’s has partnered with the Biotechnology Industry Research Assistance Council (BIRAC), Department of Biotechnology (DBT) for advisory support and to use BIRAC’s clinical trial centres for the vaccine. Recently, RDIF announced the second interim analysis of clinical trial data, which showed 91.4 per cent efficacy for the vaccine on day 28 after the first dose; vaccine efficacy over 95 per cent 42 days after the first dose. Currently, 40,000 volunteers are taking part in Phase III of Sputnik V clinical trials, out of which over 22,000 have been vaccinated with the first dose of the vaccine and more than 19,000 – with both the first and second doses of the vaccine. GV Prasad, Co-chairman and Managing Director, Dr Reddy’s Laboratories said, “This is another significant step as we continue to collaborate with multiple entities along with the government bodies to fast-track the process for launching the vaccine in India. We are working towards making the vaccine available with a combination of import and indigenous production model.” In September 2020, Dr Reddy’s and RDIF entered into a partnership to conduct clinical trials of the Sputnik V vaccine and the rights for distribution of the first 100 million doses in India. On August 11, 2020, the Sputnik V vaccine developed by the Gamaleya National Research Institute of Epidemiology and Microbiology was registered by the Ministry of Health of Russia and became the World’s first registered vaccine against COVID-19 based on the human adenoviral vector platform. ]]> <![CDATA[FDA approves Lupin’s Penicillamine Tablets USP]]> https://biospectrumindia.com/news/95/17691/fda-approves-lupins-penicillamine-tablets-usp.html https://biospectrumindia.com/news/95/17691/fda-approves-lupins-penicillamine-tablets-usp.html Tue, 01 Dec 2020 17:10:00 +0530 Pharma major Lupin Limited announced that it has received approval for its Penicillamine Tablets USP, 250 mg, from the United States Food and Drug Administration (US FDA), to market a generic equivalent of Depen® Tablets, 250 mg, of Mylan Specialty, LP. The product would be manufactured at Lupin’s Nagpur facility and is expected to be launched shortly. Penicillamine Tablets USP, 250 mg, are indicated in the treatment of Wilson’s disease, Cystinuria, and in patients with severe, active rheumatoid arthritis who have failed to respond to an adequate trial of conventional therapy. Penicillamine Tablets USP (RLD: Depen®) had an annual sales of approximately $4 million in the US (IQVIA MAT September 2020). ]]> <![CDATA[UK PM inspects Wockhardt’s fill finish production line ]]> https://biospectrumindia.com/news/95/17689/uk-pm-inspects-wockhardts-fill-finish-production-line-.html https://biospectrumindia.com/news/95/17689/uk-pm-inspects-wockhardts-fill-finish-production-line-.html Tue, 01 Dec 2020 15:40:00 +0530 Wockhardt, the global pharmaceutical and biotechnology major headquartered in Mumbai, hosted a visit at its Wrexham facility in North Wales of the Prime Minister of the United Kingdom, Boris Johnson on 30th November. The Prime Minister inspected the Wockhardt’s fill-finish production line and was accompanied by local Wrexham Conservative MP Sarah Atherton. The UK Government has reserved one fill and finish production line at Wockhardt UK for its exclusive use for 18 months in order to guarantee the supply of vaccines required to fight against COVID-19. Wockhardt is a global pharmaceutical and biotech organization that brings affordable, high-quality medicines to market. As a global organization, Wockhardt is focussed and committed to assisting in mitigating the worldwide impact of COVID-19 and the collaboration with the UK Government to make vaccines available upholds its ongoing commitment to fight against such a pandemic of global human importance. In the UK, Wockhardt is one of the largest suppliers into the NHS for over 20 years, has had a presence in Wrexham for over two decades and employs over 400 people at its 612,000 square feet high-tech manufacturing facility. Wockhardt’s New Drug Discovery programme has focussed on the unmet need of making anti-bacterial drugs effective in mitigating untreatable superbugs. Wockhardt is the only company in the world that has received  QIDP  Status (Qualified Infectious  Diseases Programme) from the US FDA for six anti-bacterial discovery programs – three of them are Gram-Negative and three Gram-Positive and are effective against untreatable “Superbugs”. Wockhardt has a dedicated and experienced Drug Discovery team as part of its clinical research organization.     ]]> <![CDATA[Curatio launches India's first AI powered conversational bot in healthcare]]> https://biospectrumindia.com/news/95/17682/curatio-launches-indias-first-ai-powered-conversational-bot-in-healthcare.html https://biospectrumindia.com/news/95/17682/curatio-launches-indias-first-ai-powered-conversational-bot-in-healthcare.html Tue, 01 Dec 2020 00:00:00 +0530 Chennai-based Curatio Healthcare, pioneers of dermatology and paediatric dermatology products since 2005, has teamed up with Mumbai based Conversational AI Company Engagely.ai to introduce India's first and one of its kind Artificial Intelligence Powered Conversational bot in the healthcare industry. Speaking about the initiative, PV Sankar Dass, CEO, Curatio Healthcare said, "We pride ourselves on being a customer-centric company. Until recently, our customer care team, marketing and sales team used to answer customer queries via our helpline or our customer care email. We wanted to enhance the customer experience and provide 24x7 support on general queries which can be addressed by 'Quree' (The Chatbot)." Generally, patients visiting a doctor have a few queries that remain unanswered or may need more information at the time of usage of a product. Not always can they find accurate information on search engines or call their doctor again for all their little doubts. "This was the starting point of the chatbot idea. We wanted to provide accurate information, allay their fears and build a community too. It made more sense considering the pandemic affected world where questions are many and misinformation is rampant," he added. "We encourage our employees to share ideas and the AI bot idea was a result of such internal brainstorming. After extensive due diligence, we zeroed in on Engagely.ai, one of the most advanced and trusted conversational AI platforms. In record time, it was launched by the team, and we are getting excellent feedback and are seeing massive uplift in Customer experience and support KPIs," he said. Himanshu Chauhan, Global Head, Engagely.ai said, "We believe the introduction of this AI chatbot will significantly impact the digital customer engagement of Curatio. Over 81 per cent of companies view customer experience as a competitive differentiator in decision making and conversational AI Bot helps in transforming your customer experience to the next level. Engagely.ai's Conversational AI Bots deliver effective customer experience on any desired channel and in the customer's preferred language using its proprietary ML engine.” ]]> <![CDATA[Marine Bio donates protective masks to Rajiv Gandhi Govt General Hospital, as part of CSR towards COVID-19 warriors]]> https://biospectrumindia.com/news/95/17680/marine-bio-donates-protective-masks-to-rajiv-gandhi-govt-general-hospital-as-part-of-csr-towards-covid-19-warriors.html https://biospectrumindia.com/news/95/17680/marine-bio-donates-protective-masks-to-rajiv-gandhi-govt-general-hospital-as-part-of-csr-towards-covid-19-warriors.html Mon, 30 Nov 2020 17:35:00 +0530 Marine Bio Co Ltd, a South Korean firm with the support of the Korean Trade-Investment Promotion Agency (KOTRA) donated hundreds of high-end Air Queen masks to Rajiv Gandhi Government General Hospital, as part of the corporate social responsibility initiative towards COVID-19 warriors. Dr E Theranirajan, Dean, Rajiv Gandhi Government General Hospital, received the high-end protective Air Queen masks from Marine Bio Co Ltd. Dr Theranirajan said, “Living in pandemic times, the need for protective face masks for the medical professionals is always critical. I thank Marine Bio and KOTRA for their kind gesture and support in the fight against coronavirus.” The Air Queen antibacterial nanofiber mask consists of three layers, three panels, and a fold, which filters virus and bacteria efficiently. The nanofiber filter’s average space is smaller than 1(0.6) micrometre (µm), which prevents the penetration of droplets and aerosol and ensures better prevention of viruses caused due to transmission. The product is a lightweight, ergonomic design that is certified by the US FDA and CE and it falls under the FFP2 category. Heo Yun-Young, CEO, Marine Bio Co Ltd, South Korea said, “The pandemic is unprecedented and the fight against the crisis is ongoing. It is essential to support the medical professionals, who work tirelessly on the frontlines of the pandemic. It is vital to safeguard the health of our medical personnel. We are glad to extend our support to Rajiv Gandhi Government General Hospital.” ]]> <![CDATA[PM interacts with three teams of COVID-19 vaccine developers ]]> https://biospectrumindia.com/news/95/17677/pm-interacts-with-three-teams-of-covid-19-vaccine-developers-.html https://biospectrumindia.com/news/95/17677/pm-interacts-with-three-teams-of-covid-19-vaccine-developers-.html Mon, 30 Nov 2020 14:45:00 +0530 Prime Minister Narendra Modi had virtual meetings with three teams working on developing & manufacturing vaccine for COVID-19. These teams were from Gennova Biopharmaceuticals Ltd Pune, Biological E Ltd Hyderabad and Dr Reddy’s Laboratories Ltd Hyderabad. The PM appreciated the efforts being taken by the scientists in these companies to come out with a vaccine solution to tackle COVID-19. The potential of various platforms for vaccine development was also discussed. PM also asked the companies to come out with their suggestions and ideas regarding the regulatory processes and related matters. He also suggested that they should take extra efforts to inform the general public in simple language about the vaccine and related matters such as its efficacy etc. Matters relating to logistics, transport, cold chain etc in respect of delivering the vaccines were also discussed. All the vaccine candidates discussed are at different stages of trials and detailed data and results are expected early next year onwards. The PM advised all the departments concerned to engage with the manufacturers and seek to resolve matters so that the efforts by these companies bear fruit in order to serve the needs of the country and the entire world. ]]> <![CDATA[Dr Reddy’s to acquire select anti-allergy brands from Glenmark]]> https://biospectrumindia.com/news/95/17674/dr-reddys-to-acquire-select-anti-allergy-brands-from-glenmark.html https://biospectrumindia.com/news/95/17674/dr-reddys-to-acquire-select-anti-allergy-brands-from-glenmark.html Mon, 30 Nov 2020 11:35:00 +0530 Dr Reddy’s Laboratories Ltd has announced that it has entered into a definitive agreement with Glenmark Pharmaceuticals Ltd to acquire, subject to completion of certain precedent actions and closing activities, brands Momat Rino (for Russia, Kazakhstan and Uzbekistan), Momat Rino Advance (for Russia), Momat A (for Kazakhstan and Uzbekistan), Glenspray and Glenspray Active (for Ukraine), along-with rights to the trademarks, dossiers and patents for the territories mentioned. The acquired brands represent two types of products, (a) mometasone mono product and (b) combination of mometasone with azelastine, and are indicated for the treatment of Seasonal and Perennial Allergic Rhinitis. MV Ramana, Chief Executive Officer, Branded Markets (India and Emerging Markets), Dr Reddy’s said, “The new brands are a great addition to our product portfolio in Russia, Ukraine, Kazakhstan and Uzbekistan which are important core markets for us. Momat Rino, the largest brand acquired, has recently received OTC registration in Russia and this will enable accelerated access of this product to patients. The acquired products will further add to Dr Reddy’s strong presence in the anti-allergy segment in these countries, and will also enable us to offer a more comprehensive solution to patients in this area.” ]]> <![CDATA[Dr. Reddy’s to acquire select anti-allergy brands from Glenmark in Russia, Ukraine, Kazakhstan and Uzbekistan]]> https://biospectrumindia.com/news/95/17673/dr-reddys-to-acquire-select-anti-allergy-brands-from-glenmark-in-russia-ukraine-kazakhstan-and-uzbekistan.html https://biospectrumindia.com/news/95/17673/dr-reddys-to-acquire-select-anti-allergy-brands-from-glenmark-in-russia-ukraine-kazakhstan-and-uzbekistan.html Mon, 30 Nov 2020 11:20:00 +0530 Dr Reddy’s Laboratories along with its subsidiaries together referred to as “Dr. Reddy’s”) today announced that it has entered into a definitive agreement with Glenmark Pharmaceuticals Ltd. to acquire, subject to completion of certain precedent actions and closing activities, brands Momat Rino (for Russia, Kazakhstan and Uzbekistan), Momat Rino Advance (for Russia), Momat A (for Kazakhstan and Uzbekistan), Glenspray and Glenspray Active (for Ukraine), along-with rights to the trademarks, dossiers and patents for the territories mentioned. The acquired brands represent two types of products, (a) mometasone mono-product and (b) combination of mometasone with azelastine, and are indicated for the treatment of Seasonal and Perennial Allergic Rhinitis. M V Ramana, Chief Executive Officer, Branded Markets (India and Emerging Markets) of Dr. Reddy’s said, “The new brands are a great addition to our product portfolio in Russia, Ukraine, Kazakhstan and Uzbekistan which are important core markets for us. Momat Rino, the largest brand acquired, has recently received OTC registration in Russia and this will enable accelerated access of this product to patients. The acquired products will further add to Dr. Reddy’s strong presence in the anti-allergy segment in these countries, and will also enable us to offer a more comprehensive solution to patients in this area.”   ]]> <![CDATA[HopeQure expands footprints in US markets]]> https://biospectrumindia.com/news/95/17669/hopequre-expands-footprints-in-us-markets.html https://biospectrumindia.com/news/95/17669/hopequre-expands-footprints-in-us-markets.html Fri, 27 Nov 2020 16:05:00 +0530 HopeQure, India’s fastest growing online mental health counseling platform based in New Delhi, achieves HIPPA (Health Insurance Portability and Accountability Act) security certification. Armed with HIPAA certification, HopeQure now plans to launch its operations in USA where the company is in advance stage of discussion to finalise its partners for growth. Bringing the global best practices and international security and confidentiality standards in mental health domain in India was necessary as this is customers topmost concern while dealing with mental health related issues. HopeQure is the fastest growing and highly admired online mental health video counselling platform for behavioral, psychological, emotional and relationship counselling. Its fully automated advance tech online video counselling platform is preferred by psychologists and clients for its pre and post counselling assistance while it is preferred by corporates for fully automated and customizable corporate employee mental wellness program. HopeQure has been leading the mental health counselling industry in India with its active interactions with stakeholders including the insurance companies for complying with the latest supreme court directive, IRDA and government order on inclusion of mental health treatment under insurance plans, acceptance of mental health as a normal pre-existing disease and to promote mental health counselling and make it affordable through insurance policies for the benefit of common people in India.  ]]> <![CDATA[RDIF, Hetero to produce over 100 M Sputnik V doses in India]]> https://biospectrumindia.com/news/95/17667/rdif-hetero-to-produce-over-100-m-sputnik-v-doses-in-india.html https://biospectrumindia.com/news/95/17667/rdif-hetero-to-produce-over-100-m-sputnik-v-doses-in-india.html Fri, 27 Nov 2020 12:05:00 +0530 The Russian Direct Investment Fund (RDIF) and Hyderabad based Hetero Labs, through its biologics arm Hetero Biopharma, have agreed to produce in India over 100 million doses per year of the world’s first registered vaccine against the novel coronavirus infection – Sputnik V. The parties intend to start the production of Sputnik V in the beginning of 2021. The Gamaleya Center and RDIF announced on November 24 positive results obtained during the second interim data analysis of the largest double-blind, randomised, placebo-controlled Phase III clinical trials in Russia’s history involving 40,000 volunteers. Currently Phase III clinical trials are approved and are ongoing in Belarus, the UAE, Venezuela and other countries, as well as Phase II-III in India. Requests for more than 1.2 billion doses of Sputnik V vaccine came from more than 50 countries. The vaccine supplies for the global market will be produced by RDIF’s international partners in India, Brazil, China, South Korea and other countries. Kirill Dmitriev, CEO, Russian Direct Investment Fund, commented,  “We are delighted to announce the agreement between RDIF and Hetero that will pave the way to production of the safe and highly effective Sputnik V vaccine on Indian soil. The vaccine’s interim clinical trial results show 95 per cent efficacy on the 42nd day after the first dose. I am confident that Sputnik V should become an integral part of the national vaccine portfolio of every country willing to protect its population from the coronavirus.” B Murali Krishna Reddy, Director – International Marketing, Hetero Labs Limited said, “We are pleased to collaborate with RDIF as a manufacturing partner for the most anticipated Sputnik V vaccine for the treatment of COVID-19.  While we look forward to the clinical trial results in India, we believe that manufacturing the product locally is crucial to enable swift access to patients.” ]]> <![CDATA[AIOCD pushes govt for effective distribution of COVID-19 vaccines]]> https://biospectrumindia.com/news/95/17659/aiocd-pushes-govt-for-effective-distribution-of-covid-19-vaccines.html https://biospectrumindia.com/news/95/17659/aiocd-pushes-govt-for-effective-distribution-of-covid-19-vaccines.html Thu, 26 Nov 2020 12:30:00 +0530 All Indian Origin Chemists & Distributors Ltd (AIOCD Ltd), based in Mumbai, is making efforts to convince the Government for utilizing a trade channel for the distribution of COVID vaccines likely available in India. AIOCD being Jan Swasthya Rakshak Chemists of the country serving the nation by providing medicines in nook and corner of the country has the best possible way for the large population waiting for the vaccine. Furthermore, the company as pharmacist and chemists have the duty to co-operate local and State Government to provide the Covid vaccine for the public. The company has even shared some aspects that need to be ensured for vaccine storage. The vaccine storage requires: +2 degree C to +8 degree C temperature range throughout production, storage & delivery stages COVID vaccines may require a temperature less than -20 degree C AIOCD is preparing a PowerPoint presentation for cold chain management based on requirements, which will be sent to all States and districts to improve the cold chain management. Covid Vaccine will also be required to be stored and transported in cold temperature containers like other vaccines. This could be a potential constraint, especially with a large number of doses as vaccines may lose potency when exposed to higher temperatures. Thus, temperature plays a critical role in preserving the efficacy of any vaccine.   ]]> <![CDATA[Lupin launches generic equivalent of immunosuppressant]]> https://biospectrumindia.com/news/95/17656/lupin-launches-generic-equivalent-of-immunosuppressant.html https://biospectrumindia.com/news/95/17656/lupin-launches-generic-equivalent-of-immunosuppressant.html Wed, 25 Nov 2020 16:20:00 +0530 Lupin has announced the launch of Tacrolimus Capsules USP, 0.5 mg, 1 mg, and 5 mg, after Lupin’s alliance partner Concord Biotech received approval for its ANDA from the United States Food and Drug Administration (US FDA). Tacrolimus Capsules USP, 0.5 mg, 1 mg, and 5 mg, are the generic equivalent of Prograf Capsules, 0.5 mg, 1 mg, and 5 mg, of Astellas Pharma US, and are indicated for the prophylaxis of organ rejection, in adult patients receiving allogeneic kidney transplant, liver transplant, and heart transplant, and in paediatric patients receiving allogeneic liver transplants, in combination with other immunosuppressants. Tacrolimus Capsules USP, 0.5 mg, 1 mg, and 5 mg (RLD: Prograf) had an annual sales of approximately $303 million in the US (IQVIA MAT September 2020). ]]> <![CDATA[GSK Consumer Healthcare launches denture care brand in India ]]> https://biospectrumindia.com/news/95/17654/gsk-consumer-healthcare-launches-denture-care-brand-in-india-.html https://biospectrumindia.com/news/95/17654/gsk-consumer-healthcare-launches-denture-care-brand-in-india-.html Wed, 25 Nov 2020 13:45:00 +0530 GSK Consumer Healthcare has introduced Polident in India. Backed by science, Polident is the global market leader in denture care and offers products to improve comfort, hygiene & oral health of denture wearers. The launch marks GSK’s foray into the specialised Denture Care category & reinforces its presence in the overall oral health category. Significant number of Denture Wearers today face discomfort while eating, speaking or even smiling with dentures. Polident Denture fixative cream creates a seal between denture and gum tissues – keeping out food particles and providing a strong, all day hold for dentures. Because of improved fit & comfort, Denture Wearers are able to eat, speak, smile & live with confidence without worrying about their dentures. Across the world, Polident has made a significant improvement in quality of life of Denture wearers. The product is free of zinc, as well as artificial colours and flavours – and therefore will not interfere with the taste of food. Anurita Chopra, Area Marketing Director, Oral Health, GSK Consumer Healthcare said, “Being a consumer preferred and leading Denture Care brand globally, we are confident that Polident will be well received by Denture wearers in India.” Polident Denture fixative will be available pan-India across pharmacies and leading e-commerce platforms. It is available in a pack size of 20 gm for Rs 315. Dental Experts and Chemists will play a critical role in establishing this nascent category in India. The company will therefore work with experts, who will develop India’s first Denture Care Guidelines – which will put in place a go-to-guide for use of Denture Care products in the country. The launch will also be supported with a strong media plan. The launch strengthens GSK’s Oral Health portfolio in India making it one of the formidable players in the space. Currently, the oral health portfolio consists of Sensodyne range of toothpaste and toothbrush especially designed for people with sensitive teeth. ]]> <![CDATA[Indian Immunologicals invests Rs 150 Cr in 2 new facilities]]> https://biospectrumindia.com/news/95/17653/indian-immunologicals-invests-rs-150-cr-in-2-new-facilities.html https://biospectrumindia.com/news/95/17653/indian-immunologicals-invests-rs-150-cr-in-2-new-facilities.html Wed, 25 Nov 2020 13:30:00 +0530 Indian Immunologicals Ltd (IIL) has announced the ground-breaking of a new viral antigen manufacturing facility in Phase III of Genome Valley, Karkapatla, Ranga Reddy District, Telangana.  With this investment of Rs 75 crore in the upcoming facility, Indian Immunologicals Limited expects to increase its capacity to supply additional quantities of high-quality and safe vaccines. The new facility will be specially designed as a multi-product facility and to cater to the need for viral vaccines in the pipeline that includes Dengue, Zika and Varicella. The senior management of the company including Dr K Anand Kumar, Managing Director and Dr Prasanna Deshpande, Deputy Managing Director were present during the ground-breaking of the upcoming viral antigen plant. Spread across 2,000 square meters, the state-of-the-art new plant will be designed with the latest biosafety - Bio Safety Level 3 suite and will complement Indian Immunologicals’ existing operation adding more equipped and high-speed production.  The company also plans to utilise the cutting-edge facility to manufacture COVID-19 vaccines post completion of its R&D with Griffith University, Australia. The Company also inaugurated a new Sterile Filling Facility that was commissioned last year at an additional investment of Rs 75 crore. This facility will increase IIL’s capacity to supply lifesaving vaccines such as the Anti Rabies Vaccine (ARV) – Abhayrab™. As a part of the expansion plan, Indian Immunologicals Limited will add over 150 new positions, bringing its total staff strength close to 1,500. The new facility will boost the production capacity by over 35 per cent and increase the supply capacity to key markets where rabies vaccine is critically needed. Dr Kumar said, “The total investment of over Rs 150 crore in in the same direction of our vision to increase the production capacities to ensure a reliable and affordable supply of high-quality vaccines to larger communities.” “The new plant is expected to be ready for operation by October 2021,” added Dr Deshpande. IIL has 4 manufacturing facilities at various locations – Karkapatla, Telangana – Human Vaccines & Animal Health Formulations; Ooty, Tamil Nadu – Anti Rabies production unit; Hyderabad, Telangana – Human Biologicals Unit (Gachibowli) and animal vaccines unit; Dargaville, New Zealand - New Bovine Serum.   Image caption- Left to right- Kamesh CHB, HR - IIL; Dr. Prasanna Deshpande, Deputy Managing Director, IIL; Dr. K Anand Kumar, Managing Director, IIL; MC Bhagyan Muthiah, VP - HR, IIL and Dr. Rajendra Ligala, VP, R&D, IIL   ]]> <![CDATA[Micro Labs launches cheaper version of diabetes combo drug]]> https://biospectrumindia.com/news/95/17652/micro-labs-launches-cheaper-version-of-diabetes-combo-drug.html https://biospectrumindia.com/news/95/17652/micro-labs-launches-cheaper-version-of-diabetes-combo-drug.html Tue, 24 Nov 2020 19:30:00 +0530 Micro Labs, based in Bengaluru, has announced the launch of anti-diabetic drug combo Dapagliflozin plus Metformin tablets under the brand name ZUCAPRIDE- M.  ZUCAPRIDE –M comes in two strengths ZUCAPRIDE –M 500 priced at Rs 12.80 per tablet and ZUCAPRIDE –M 1000 at Rs 14.80 against Rs 57.70 and 59.80 of existing brands in the market. In terms of monthly savings, a patient can save up to Rs 1347 when prescribed Zucapride M 500 & Rs 1350 when prescribed Zucapride M 1000. "Diabetes is a key area of focus for Micro Labs and with this launch, the company aims to access the 1000 Crs SGLT2 inhibitors market, by providing an effective, high quality and world-class treatment option to patients in India. Besides, strong R&D efforts have helped us develop our own API which is at par with the innovator brand,” says Ashok Jain, Executive Director, Micro Labs Ltd. ZUCAPRIDE- M, a once-daily oral treatment indicated as an adjunct to diet and exercise, aims to improve glycaemic control in adults with type 2 diabetes. ZUCAPRIDE -M contains two active pharmaceutical ingredients (APIs) Dapagliflozin, a novel anti-diabetic class called sodium-glucose co-transporter 2 (SGLT2) inhibitor & Metformin, a widely prescribed oral anti-diabetic drug. “This combination is set to gain acceptance as second line therapy for the management of diabetes owing to the large amount of published dapagliflozin data on cardio-renal safety and weight loss in diabetes individuals besides reduction of blood glucose levels” as per Dr S Manjula, Sr VP, Medical Services, Micro Labs Ltd. ]]> <![CDATA[Axio Biosolutions enters retail space in India]]> https://biospectrumindia.com/news/95/17647/axio-biosolutions-enters-retail-space-in-india.html https://biospectrumindia.com/news/95/17647/axio-biosolutions-enters-retail-space-in-india.html Tue, 24 Nov 2020 15:15:00 +0530 Axio Biosolutions has announced its strategic decision to enter the retail space in India. Axio is set to make its best-in-class wound care and Covid essential products available for Indian homes across 50 cities in the next one year. The B2C / D2C move is aimed at consolidating the company’s leadership position in the global advanced wound care space. Funded by Ratan Tata, Omidyar Network, Accel and Chiratae Ventures, Axio has seen exponential growth in the international markets in the last few years. With its patented and US FDA approved product, Axiostat– that stops uncontrollable bleeding within a few minutes of its application– Axio has the distinction of being the only company in Asia and among the top five global companies with the unique bleeding-control technology. With its presence in over 18 countries across the globe, Axiostat is the only ‘Made-in-India’ product to compete in the global market. With Axio’s entry into retail, consumers will now have access to world-class products such as : ASK+ Kits –  that consist of  Axiostat and other first-aid dressings that stop uncontrollable bleeding. MaxioCel – an advanced wound care dressing to provide comfort and faster healing to patients suffering from chronic wounds, such as pressure ulcers, diabetic foot ulcers, venous leg ulcers, post-operative surgical wounds and cavity wounds, among others RESIST+ – Covid essentials manufactured in compliance with WHO standards and pharma regulations. Products in this range include surgical disinfectants, hand sanitisers, multi-surface disinfectant sprays, and alcohol sanitising wipes among others. Commenting on the company’s latest development, Leo Mavely, CEO and Founder, Axio Biosolutions, said, “In an era of teleconsultations, democratisation of critical care products can elevate the overall health and safety ecosystem in the country.” In addition to the products being available on the company’s online store (www.axiobiostore.com), Axio has partnered with over 6,000+ brick-and-mortar stores as well as popular e-commerce platforms, such as Flipkart, Amazon, Moglix, to deliver its products directly to the end consumer. Axio Biosolutions has its corporate office in Bengaluru and a GMP, ISO 13485-certified manufacturing facility in Gujarat. ]]> <![CDATA[Favipiravir significantly improving clinical cure in COVID-19 patients]]> https://biospectrumindia.com/news/95/17645/favipiravir-significantly-improving-clinical-cure-in-covid-19-patients.html https://biospectrumindia.com/news/95/17645/favipiravir-significantly-improving-clinical-cure-in-covid-19-patients.html Tue, 24 Nov 2020 14:10:00 +0530 The oral antiviral medication Favipiravir, that prevents the replication phase of the virus life-cycle, leads to significant improvement in clinical cure in patients with mild to moderate COVID-19. These findings were observed in a randomised, controlled Phase 3 clinical study conducted by Glenmark Pharmaceuticals, and the results are now published online in The International Journal of Infectious Diseases (IJID). The IJID is a globally reputed, peer-reviewed, pubmed indexed, open access journal published monthly by the International Society for Infectious Diseases, US. The Phase 3 study with antiviral drug Favipiravir, brand name FabiFlu®, was conducted in 150 patients as part of a randomised, open label, multicentre, Phase 3 study. The study aimed to evaluate the efficacy and safety of Favipiravir plus standard supportive care (Favipiravir treatment arm), versus standard supportive care alone (control arm), in mild to moderate patients, randomised within a 48 hour window of testing RT-PCR positive for COVID-19. Favipiravir was found to provide multiple treatment benefits, demonstrated by faster time to clinical cure, and significantly delayed the need for supportive oxygen therapy. Additionally, patients of confirmed COVID-19 with moderate symptoms were discharged from hospital earlier than those patients that did not receive Favipiravir, with the median time to clinical cure reduced by 2.5 days compared with the control group. Robert Crockart, Chief Commercial Officer, Glenmark Pharmaceuticals, said, "It is encouraging to see our trial results now published in a reputed global medical journal, which we hope will support other countries in their fight against this disease.” Patients in the Glenmark clinical trial received Favipiravir tablets 3,600 mg (1,800 mg BID) (Day 1) + 1,600 mg (800 mg BID) (Day 2 or later) for up to maximum of 14 days, along with standard supportive care. Randomisation was stratified based on disease severity into mild and moderate. Favipiravir was well tolerated with no serious adverse events (SAEs) or deaths in the Favipiravir treated arm. The pre-specified primary endpoint, time from randomisation to cessation of oral shedding of the SARS-CoV-2 virus, demonstrated a two day earlier virological cure in the Favipiravir treatment group, though not statistically significant. However, significant improvement in time to clinical cure and other secondary end-points suggest Favipiravir may be beneficial in the treatment of mild-to-moderate COVID-19.  ]]> <![CDATA[Syngene, Deerfield collaborate to advance therapeutic discovery projects]]> https://biospectrumindia.com/news/95/17632/syngene-deerfieldcollaborate-to-advance-therapeutic-discovery-projects.html https://biospectrumindia.com/news/95/17632/syngene-deerfieldcollaborate-to-advance-therapeutic-discovery-projects.html Fri, 20 Nov 2020 12:45:00 +0530 Syngene International and Deerfield Discovery and Development Corporation (3DC), the drug discovery and development subsidiary of Deerfield Management Company (Deerfield) based in the US, have signed an agreement to collaborate to advance therapeutic discovery projects, from target validation through to pharmacological proof of concept and preclinical evaluation. This five-year collaboration unites the core skills of the investment management company Deerfield, through its drug discovery and development arm 3DC, and Syngene’s integrated drug discovery (IDD) services. Syngene’s Managing Director and CEO, Jonathan Hunt, said: “Syngene will deliver fully integrated therapeutic discovery programmes for 3DC. Syngene is an industry-leading collaboration partner for pharma, biotech, and venture capital firms, and we are delighted to have 3DC as a major strategic partner. Their reputation for identifying highly promising science is a great fit with our ability to lead and deliver world-class scientific execution for their growing portfolio.” “This collaboration forms an important part of our execution strategy. When we identify a promising biological target, our goal is to discover and deliver the best possible therapeutic agent to the clinic as quickly and safely as possible,” said Mike Foley, CEO, 3DC. “We believe the Syngene-Deerfield collaboration may provide critical new therapeutic options with pace and efficiency that could improve the lives of many patients.” 3DC has selected Syngene as a key execution partner for a developing portfolio of molecular entities, spanning multiple therapeutic areas and modalities. The ultimate goal is to deliver much-needed benefit to patients suffering from serious, unmet medical needs through innovation, scale, quality, and speed-to-market. The collaboration will start with immediate effect and is expected to run for an initial cycle of 5 years. ]]> <![CDATA[Cipla unveils Covi-G for COVID-19 rapid antibody detection]]> https://biospectrumindia.com/news/95/17616/cipla-unveils-covi-g-for-covid-19-rapid-antibody-detection.html https://biospectrumindia.com/news/95/17616/cipla-unveils-covi-g-for-covid-19-rapid-antibody-detection.html Wed, 18 Nov 2020 14:40:00 +0530 Cipla has announced that it signed a licensing agreement with a Belgium-based firm, Multi G for the distribution of their COVID-19 Rapid Antibody test kit, across most emerging markets and Europe. This licensing agreement is part of Cipla’s efforts to enhance global access to life- saving treatments and diagnostic infrastructure for patients in need. As part of this agreement, Cipla will be responsible for distribution of the COVID-19 rapid antibody kit that will be manufactured by MultiG. It is marketed under the brand name ‘Covi-G’, this was among the earliest Antibody kits to declare CE-compliance and is awaiting approval by ICH country regulators It has been commercialised in 20+ countries already, with sensitivity and specificity exceeding 92 per cent.  It tests for both IgM and IgG antibodies, using a single-prick blood test using of the test result indicator visual interpretation. The kit gives results within 10 minutes. Cipla’s expansive reach, network and partnerships with public health authorities as well as private institutions will help in ensuring the seamless access of these kits across 25+ markets in Asia, Middle-East and North Africa, Latin America, EU and Australia. This launch marks yet another addition to Cipla’s COVID portfolio after ELIFAST diagnostic kits. Apart from an epidemiological tool for mass screening, this point of care test can also be used to detect patients who have had a suspected asymptomatic or mild infection in the past, identify potential plasma donors and possibly prioritise susceptible populations for vaccines. ]]> <![CDATA[Zydus reports increased viral reduction with PegiHep in COVID-19 patients]]> https://biospectrumindia.com/news/95/17610/zydus-reports-increased-viral-reduction-with-pegihep-in-covid-19-patients.html https://biospectrumindia.com/news/95/17610/zydus-reports-increased-viral-reduction-with-pegihep-in-covid-19-patients.html Tue, 17 Nov 2020 00:00:00 +0530 Zydus Cadila has announced that it has successfully completed a Phase 2 clinical trial in CoVID-19 patients with its biological therapy, Pegylated Interferon alpha-2b, ‘PegiHepTM’. In this open-label, randomized, comparator controlled study, involving 40 adult patients with moderate COVID-19 disease, 95% subjects in the test arm who received a single dose of PegiHepTM along with the Standard Of Care (SOC), became virus free as assessed by RT-PCR on day 14 and showed a statistically significant clinical improvement over the patients in the reference arm, who received only the standard of care and where only 68% patients showed an improvement in clinical symptoms and became RT-PCR negative. In the test arm 16 subjects were RT-PCR negative as early as day 7 of treatment which was an improvement over the reference arm. Clinical improvement was assessed using a seven point ordinal scale where the patients were assessed on multiple criteria such as requirement and duration of hospitalization, ventilation, supplemental oxygen etc. The study established the early safety, efficacy and tolerability of PegiHepTM in moderate COVID-19 patients. The study so far has indicated that Pegylated Interferon alpha-2b could have a beneficial impact on the patient suffering from moderate COVID 19 disease by reducing their viral load helping in better disease management such as reduced duration of oxygen support. Moreover, a single dose therapy will improve compliance and also make it highly affordable for patients. Pegylated Interferon alpha-2b is not a new therapy. The product was first approved internationally in 2001 and is also included in WHO’s Essential Medicines List. Zydus Cadila’s Pegylated Interferon alpha-2b, PegiHepTM, was originally approved for Hepatitis C and was launched in the Indian market in 2011. Speaking on the development, Dr. Sharvil Patel, Managing Director, Cadila Healthcare Ltd., said, “We continue to look at possible treatment options that are safe and efficacious in the treatment and management of COVID 19. Pegylated Interferon alpha-2b has shown the potential to reduce virus titres when given earlier in the disease and we will like to explore this biological option further. We are hopeful of reinforcing our treatment options to fight COVID 19.” Based upon the results from its Phase 2 study, Zydus Cadila now plans to conduct a Phase 3 clinical trial in India. The Company is also conducting a similar Phase 2 trial in Mexico. The Company is also working with the USFDA to open an Investigational New Drug (IND) application for Pegylated Interferon alpha-2b in order to initiate appropriate clinical trials in US. ]]> <![CDATA[Biological E initiates Ph I/II trial of COVID-19 vaccine candidate]]> https://biospectrumindia.com/news/95/17604/biological-e-initiates-ph-i-ii-trial-of-covid-19-vaccine-candidate.html https://biospectrumindia.com/news/95/17604/biological-e-initiates-ph-i-ii-trial-of-covid-19-vaccine-candidate.html Mon, 16 Nov 2020 18:05:00 +0530 Biological E Limited (BE), a Hyderabad-based vaccines and pharmaceutical company, Dynavax Technologies Corporation, US-based vaccine focused biopharmaceutical company, and Baylor College of Medicine, a health sciences university in Houston, TX, have announced that BE has initiated a Phase I/II clinical trial of its COVID-19 subunit vaccine candidate in India following approval from the Drugs Controller General of India (DGCI). The vaccine candidate includes an antigen in-licensed from BCM Ventures, Baylor College of Medicine's integrated commercialisation team, along with Dynavax's advanced adjuvant CpG 1018. BE's Phase I/II clinical trial will evaluate the safety and immunogenicity of the vaccine candidate consisting of the Receptor Binding Domain of the Spike Protein of SARS-CoV-2 at three dose levels adjuvanted with CpG 1018 plus alum, in about 360 healthy subjects in the age range of 18 to 65 years. The vaccination schedule consists of two doses for each study participant, administered via intramuscular injection 28 days apart. The results of this clinical trial are expected to be available by February 2021. "The transition of our vaccine candidate into human trials is an important milestone, and exemplifies a successful transfer of technology with BE, that could lead to a safe, effective and affordable vaccine," said Dr Maria Elena Bottazzi, Associate Dean, National School of Tropical Medicine, Baylor College of Medicine and Co-Director, Texas Children's Hospital Centre for Vaccine Development.  "This vaccine represents an urgent biotechnology innovation for ensuring health equity and combating the COVID-19 pandemic," said Dr Peter Hotez, Professor, Dean, National School of Tropical Medicine, Baylor and Co-Director, Texas Children's Hospital Centre for Vaccine Development. "We are very happy indeed to transition our potential vaccine candidate to clinical trials and offer one more potential option for the prophylaxis of COVID-19," said Mahima Datla, Managing Director, Biological E Limited. "We are proud to contribute CpG 1018 to support development of an adjuvanted vaccine to prevent COVID-19. CpG 1018's potential to boost the immune response to produce more antibodies and longer lasting immunity may also minimise the dose of antigen needed, enabling vaccination of a greater number of people,” commented Ryan Spencer, Chief Executive Officer, Dynavax. ]]> <![CDATA[Dr Reddy’s launches succinylcholine chloride injection]]> https://biospectrumindia.com/news/95/17597/dr-reddys-launches-succinylcholine-chloride-injection.html https://biospectrumindia.com/news/95/17597/dr-reddys-launches-succinylcholine-chloride-injection.html Fri, 13 Nov 2020 15:50:00 +0530 Dr Reddy’s Laboratories announced the launch of Succinylcholine Chloride Injection USP, 200 mg/10 mL (20 mg/mL), Multiple-Dose Vials a therapeutic equivalent generic version of Quelicin® (Succinylcholine Chloride) Injection, 20 mg/mL, approved by the US Food and Drug Administration (USFDA).  The Quelicin® brand and generic market had US sales of approximately $74.8 million MAT for the most recent twelve months ending in September 2020 according to IQVIA Health. Dr Reddy’s Succinylcholine Chloride Injection USP, 200 mg/10 mL (20 mg/mL), is available in multi-dose vials. ]]> <![CDATA[Lupin’s Alliance Partner Concord receives FDA approval for tacrolimus capsules]]> https://biospectrumindia.com/news/95/17590/lupins-alliance-partner-concord-receives-fda-approval-for-tacrolimus-capsules.html https://biospectrumindia.com/news/95/17590/lupins-alliance-partner-concord-receives-fda-approval-for-tacrolimus-capsules.html Thu, 12 Nov 2020 16:05:00 +0530 Mumbai-based pharma major Lupin Limited (Lupin) in alliance with Concord Biotech Limited (Concord) announced today that it has received approval from the United States Food and Drug Administration (US FDA) for Tacrolimus Capsules USP, 0.5 mg, 1 mg, and 5 mg, to market a generic version of Prograf® Capsules, 0.5 mg, 1 mg, and 5 mg, of Astellas Pharma US, Inc. Tacrolimus Capsules USP are indicated for the prophylaxis of organ rejection in adult and paediatric patients receiving allogeneic liver, kidney or heart transplants, in combination with other immunosuppressants. Tacrolimus Capsules USP, 0.5 mg, 1 mg, and 5 mg (RLD: Prograf®) had an annual sales of approximately $303 million in the US (IQVIA MAT September 2020). ]]> <![CDATA[Pharma players accelerate global access to effective COVID-19 treatments]]> https://biospectrumindia.com/news/95/17585/pharma-players-accelerate-global-access-to-effective-covid-19-treatments.html https://biospectrumindia.com/news/95/17585/pharma-players-accelerate-global-access-to-effective-covid-19-treatments.html Thu, 12 Nov 2020 00:00:00 +0530 With COVID-19 infections surging worldwide, a coalition of 18 companies representing a large portion of the world’s generic pharmaceutical manufacturers pledged to work together to accelerate access to hundreds of millions of doses of new interventions for low- and middle-income countries via the non-profit Medicines Patent Pool (MPP).  The companies joining the effort are connected by their past work with MPP, an organisation created in 2010 by the global health initiative Unitaid to negotiate patent licence agreements with pharmaceutical companies that are placed in a pool to make them more easily accessible for generic manufacturers. Thus far, agreements negotiated by MPP with companies such as ViiV Healthcare, Bristol Myers Squibb and Abbvie have allowed generic producers to provide over 15 billion doses of HIV and hepatitis C medicines to low- and middle-income countries. Despite the logistical challenges of the pandemic, in the first six months of 2020 alone, MPP’s licensees have delivered three billion doses. Combining the capacity of generic firms with patent agreements negotiated by MPP is increasingly viewed as an important addition to efforts to ensure COVID-19 interventions are available outside of the world’s wealthiest countries. Full list of first signees of the open pledge: Adcock Ingram Arene Aurobindo Beximco Celltrion Desano Emcure Hetero Langhua Pharma Laurus Labs Lupin Macleods Mangalam Micro Labs Natco Strides Shasun Sun Pharma Zydus Cadila   Collectively the 18 companies joining the pledge have the capacity to deliver substantial amounts of conventional drugs, technically known as “small molecules” in industry parlance, and an increasing ability to produce more molecules known as biologics. Biologics include monoclonal antibodies targeting COVID-19 that have shown promise as potential ways to either treat or prevent infections—but cost and manufacturing capacity pose substantial barriers to deploying them globally.    ]]> <![CDATA[Serum Institute pursues early availability of Covishield vaccine in India]]> https://biospectrumindia.com/news/95/17586/serum-institute-pursues-early-availability-of-covishield-vaccine-in-india.html https://biospectrumindia.com/news/95/17586/serum-institute-pursues-early-availability-of-covishield-vaccine-in-india.html Thu, 12 Nov 2020 00:00:00 +0530 Serum Institute of India (SII) and Indian Council of Medical Research (ICMR) have announced completion of enrolment of phase 3 clinical trials for COVISHIELD in India. ICMR and SII have further collaborated for clinical development of COVOVAX (Novavax) developed by Novavax, USA and upscaled by SII. The partnership is a stellar example of private-public institutes collaborating to mitigate the dire consequences of the pandemic outbreak. ICMR has funded  the clinical trial site fees while SII has funded  other expenses for COVISHIELD. At present, SII and ICMR are conducting Phase 2/3 clinical trial of COVISHIELD at 15 different centres, across the country. It has completed the enrolment of all 1600 participants on 31 Oct 2020. COVISHIELD has been developed at the SII Pune laboratory with a master seed from Oxford University/Astra Zeneca. The vaccine made in UK is currently being tested in large efficacy trials in UK, Brazil, South Africa and USA. The promising results of the trials so far give confidence that COVISHIELD could be a realistic solution to the deadly pandemic.  COVISHIELD is by far the most advanced vaccine in human testing in India. Based on the Phase 2/3 trial results, SII with the help of ICMR will pursue the early availability of this product for India. SII has already manufactured 40 million doses of the vaccine, under the at-risk manufacturing and stockpiling license from DCGI. Furthermore, US-based Novavax has initiated its late phase trials in South Africa and in UK and will soon commence the same in the USA. SII has received the bulk vaccine and Matrix-M adjuvant from Novavax and will soon fill and finish them in vials. This vaccine formulated at SII (COVOVAX) will be tested in a Phase 3 trial in India and an application for the same to regulatory authorities will be made soon by ICMR and SII. Commenting on the association, Adar Poonawalla, CEO of Serum Institute of India, said, “ICMR has played a huge role in coming forward and strengthening India’s fight against COVID-19. The collaboration will further aid us in putting India at the forefront of developing an immunogenic and efficacious vaccine. The pandemic has presented a chance to foster structural reforms in building robust public healthcare infrastructure. The partnership further testifies the importance of private-public institutes coming together in scaling up the management and containing the spread of the virus.”  Dr. Balram Bhargava, Director General of Indian Council of Medical Research (ICMR), commented, “At present, India plays a prominent role in vaccine development and manufacturing globally. Buoyed by the latest technology and well-equipped facilities, SII has continually proven its research and manufacturing prowess. The partnership is our contribution to lending our expertise and support to bolster our fight against the global pandemic.” ]]> <![CDATA[SCHOTT opens new glass melting tank in Gujarat with €25M investment]]> https://biospectrumindia.com/news/95/17580/schott-opens-new-glass-melting-tank-in-gujarat-with-25m-investment.html https://biospectrumindia.com/news/95/17580/schott-opens-new-glass-melting-tank-in-gujarat-with-25m-investment.html Wed, 11 Nov 2020 14:00:00 +0530 SCHOTT AG, a global leader in pharmaceutical glass manufacturing, has inaugurated a new melting tank in its Gujarat-based facility with an approximate investment of €25 million. The new tank would help increasing the plant’s production capacity by 10,000 tonnes to reach an annual capacity of 40000 metric tonnes. SCHOTT AG has been a frontrunner in the global fight against Coronavirus, with commitment to provide its specialised pharma glass used for storing billions of COVID-19 vaccines. The melting furnace has been constructed within a span of one year, to enable a 25 per cent increase in the facility’s overall production capacity, to support the pharma industry that is facing a huge demand surge for pharma packaging products. Pawan Shukla, MD, SCHOTT Glass, India shared, “SCHOTT remains committed to ensure that there is adequate supply of its high-quality pharma glass for the Indian pharma industry. Moreover, as SCHOTT’s manufacturing hub in Asia, we have taken up the responsibility to cater to our clients in India as well as in neighbouring countries.” The melting tank is a part of the company’s commitment to invest over €47 million in its Indian facility, and to double its capacity of producing the highly specialised FIOLAX® tubing material for both domestic and export demands. Despite the pandemic induced lockdown, SCHOTT employees and engineers continued working at the Jambusar facility to enable the construction of the new tank in the defined timeframe. The expansion has resulted in additional employment of over 120 skilled workforce, taking the overall count to 420 employees. Norbert Osterhage, German Project Engineer and Expert for Melting Technology, who was overseeing the project, chose to stay in India during the lockdown to ensure that the melting tank is operational in time, especially now as quality glass vials and syringes have become need of the hour for COVID-19 treatment. “Our Indian facility is an integral part of our pledge to cater to any requirement of the pharma industry in a sustainable manner,” said Dr Patrick Markschläger, Executive Vice President, SCHOTT AG, Business Unit Tubing. ]]> <![CDATA[Allana Group, Adar Poonawalla invests Rs 1.3B in pharmacy chain Wellness Forever]]> https://biospectrumindia.com/news/95/17567/allana-group-adar-poonawalla-invests-rs-1-3b-in-pharmacy-chain-wellness-forever.html https://biospectrumindia.com/news/95/17567/allana-group-adar-poonawalla-invests-rs-1-3b-in-pharmacy-chain-wellness-forever.html Mon, 09 Nov 2020 17:30:00 +0530 Wellness Forever raised Rs 1.3 billion from Allana Group, Adar Poonawalla. Existing investors include banker and renowned investor Rajiv Dadlani and venture capitalist Sajid Fazalbhoy. The company is promoted by Gulshan Bakhtiani, Ashraf Biran and Mohan Chavan. The Mumbai based company has been profitable since inception, growing 35 per cent YoY with best in class retail metrics, employs over 4,000 people among which are over 800 qualified pharmacists and has over one million loyal paid customers. Dadlani said “Given their impressive track record and company’s vision, we continue to partake as long-term investors, and support them in their amazing journey, and next phase of growth.” Sharing his views Bhaktiani, Founder & Director said, “With this round of funding, we plan to strengthen our private labels that have gained popularity over the years. We will continue to add more retail stores and reach out to our customers not just through brick and mortar outlets but also through online channels.” From being a mere start-up a decade ago, to clocking revenues of over Rs 1,000 crore for the current fiscal year, Wellness Forever has swiftly expanded its footprint to over 200 stores in Maharashtra, Goa, Karnataka. The company aims to add over 150 more stores in the next year and 1000 retail outlets in the next three years. Funds will be utilised for store expansion, strengthening their highly profitable private label brands which are under its 100 per cent subsidiary Amore which focuses on wellness and health products and invest more in e-commerce. Wellness Forever has hired JM Financial for a secondary share sale for early investors and for pre IPO preparations. The company is on track to achieve sales of around Rs 4,000 crore in the next 3-4 years with a 1,000 store count across the country. The Company saw investor interest from several reputed private equity funds but decided to go with existing investors given their tremendous expertise in FMCG, Retail and Pharma. ]]> <![CDATA[Jubilant, Aavis launch HCQ sulfate tablets in US]]> https://biospectrumindia.com/news/95/17560/jubilant-aavis-launch-hcq-sulfate-tablets-in-us.html https://biospectrumindia.com/news/95/17560/jubilant-aavis-launch-hcq-sulfate-tablets-in-us.html Mon, 09 Nov 2020 11:30:00 +0530 Jubilant Pharma Ltd. and US-based Aavis Pharmaceuticals Inc. has recently announced the launch of Hydroxychloroquine (HCQ) Sulfate tablets, 200 mg, a therapeutic equivalent version of Plaquenil (hydroxychloroquine sulfate) 200 mg in the US market. The product will be distributed by Jubilant Cadista, a unit of Jubilant Pharma Ltd. Hydroxychloroquine Sulfate Tablets are indicated for the treatment of Malaria, Lupus Erythematosus and Rheumatoid Arthritis. "We are pleased to announce the commercial launch of Hydroxychloroquine Sulfate tablets in the US through our marketing partner," stated Ashok Barot, Chairman, Aavis Pharmaceuticals. "Our team is doing their best to fulfil the current surge in demand. We'll continue our efforts to be a significant and reliable supplier of this product," stated Swapnil Shah, Managing Director, Senores Pharmaceuticals, R&D partner and an affiliate of Aavis Pharmaceuticals. "We are excited about this launch," stated Pramod Yadav, CEO, Jubilant Pharma Limited. "We are pleased to partner with Aavis to create access for the growing demand for this product and expand our basket of offerings in the US market," he added. ]]> <![CDATA[Excelra provides Cellarity access to GOSTAR database for drug discovery]]> https://biospectrumindia.com/news/95/17538/excelra-provides-cellarity-access-to-gostar-database-for-drug-discovery.html https://biospectrumindia.com/news/95/17538/excelra-provides-cellarity-access-to-gostar-database-for-drug-discovery.html Thu, 05 Nov 2020 00:00:00 +0530 Excelra, a global data science & data analytics company based in Hyderabad, and Cellarity, a US based flagship pioneering company working on the development of a new generation of medicines to treat diseases at the level of cell behaviours, have announced an agreement whereby Excelra will provide Cellarity access to its Global Online Structure Activity Relationship database (GOSTAR). GOSTAR is the world's largest small molecule medicinal chemistry intelligence platform that encompasses over 8 million compounds, linking chemical structure to biological, pharmacological and therapeutic activities. With a vast knowledge base of 28 million SAR data points, GOSTAR equips researchers in the early as well as optimization stages of drug discovery. Cellarity's drug discovery platform uses high-resolution biological data and unique machine learning capabilities to pioneer an entirely new approach to drug discovery. Cellarity is designing medicines that target and change cell behaviors to unlock treatments in a large number of disease areas. "We are looking forward to using high quality annotated GOSTAR data on millions of small molecules, while leveraging Cellarity's proprietary AI/ML modules to generate predictable drug-like molecules that ultimately guide the design of novel Cell Behavior-Targeted therapies. Our preliminary assessment gives us the confidence in the utility of GOSTAR database," said Ramakanth Sarabu, Head of Chemistry, Cellarity. "GOSTAR is a widely used structure activity relationship database in AI/ML driven drug discovery programs. We strongly believe that this collaboration equips AI/ML and medicinal chemistry researchers at Cellarity to utilize curated interactions of millions of small molecules with potential drug targets to generate novel compounds with desired pharmacological profiles," said Raveendra Dayam, Director, Chemistry Services, Excelra. ]]> <![CDATA[Zydus files IND application for NLRP3 inhibitor candidate to fight COVID-19]]> https://biospectrumindia.com/news/95/17522/zydus-files-ind-application-for-nlrp3-inhibitor-candidate-to-fight-covid-19.html https://biospectrumindia.com/news/95/17522/zydus-files-ind-application-for-nlrp3-inhibitor-candidate-to-fight-covid-19.html Tue, 03 Nov 2020 16:30:00 +0530 Zydus has announced that it has filed the IND application of ZYIL1, a novel oral small molecule NLRP3 inhibitor candidate. Following up on its initiatives to fight COVID 19 with diagnostics, vaccines and therapeutics, the company is now focussing on cutting edge research to bring targeted therapies that can selectively modulate the inflammatory responses caused by the Cytokine Storm. NLRP3 inflammasomes are involved in the inflammation process by production and release of proinflammatory cytokines IL-1β and IL-18. This harmful inflammation within the body leads to the onset and development of various kinds of diseases, including auto-immune diseases, inflammatory diseases, cardiovascular diseases, metabolic disorders, Gastro-intestinal diseases (inflammatory bowel disease), renal diseases, CNS diseases as well as Acute Respiratory Distress Syndrome (ARDS). SARS-CoV-2 has been reported to activate the innate immune signalling sensor NLRP3 inflammasome thereby leading to ‘Cytokine Storm’ in COVID-19 patients and causing Acute Respiratory Distress Syndrome (ARDS) complications like organ failures, and death in severe cases. As an NLRP3 inflammasome inhibitor, ZYIL1 will bridge a critical unmet healthcare need in several inflammatory diseases including the current pandemic of COVID-19 and address complications caused by chronic, uncontrolled inflammation. Speaking on the development, Pankaj R Patel, Chairman, Cadila Healthcare, said, “We are at the forefront of targeting the innate immune system through novel NLRP3 inflammasome inhibitors candidates with deep understanding of the inflammasome biology. We are committed to developing these pioneering novel treatments to the clinic for the patients in need.” ZYIL1, has demonstrated promising efficacy in a number of validated pre-clinical models of Inflammatory Bowel Disease (IBD), Multiple Sclerosis (MS), Sepsis and acute lung injury models of Acute Respiratory Distress Syndrome (ARDS). The studies have demonstrated that ZYIL1 can selectively suppress inflammation caused by the NLRP3 inflammasome.  ]]> <![CDATA[Biocon ranks among top 5 biotech employers globally]]> https://biospectrumindia.com/news/95/17504/biocon-ranks-among-top-5-biotech-employers-globally.html https://biospectrumindia.com/news/95/17504/biocon-ranks-among-top-5-biotech-employers-globally.html Fri, 30 Oct 2020 13:55:00 +0530 Biocon has been ranked among the Top 5 Global Biotech Employers for 2020 on the prestigious US-based Science magazine’s annual ‘Science Careers Top 20 Employers’ list. Ranked at No 5 among global pharma and biotech companies in 2020, Biocon has moved up steadily from No 7 in 2018 and No 6 in 2019. The company has consistently featured among the top global employers for eight consecutive years, since its debut on the list in 2012. According to the Top Employers Survey of approximately 7,600 respondents from across the world this year, Biocon’s ranking was based on three key attributes: ‘innovative leader in the industry’, ‘is socially responsible’ and ‘has loyal employees’. Kiran Mazumdar-Shaw, Executive Chairperson, Biocon said, “We are delighted to be ranked among the Top Five Global Biotech Employers by Science Magazine. The ranking is a recognition of the passion that our employees bring to the job, which allowed us to run essential and critical manufacturing, quality and supply operations with reduced staffing despite the severe disruptions caused by the COVID-19 outbreak, thus minimising the impact on patients and partners. Their commitment also enabled us to rapidly develop novel therapeutics for the deadly coronavirus and serve humanity by fighting COVID-19.” “We will continue to build on Biocon’s employee-friendly culture that promotes ideation, experimentation and collaboration as we aspire to create future leaders who will revolutionise healthcare through innovative products and services,” she added. The Top 5 global players in this year’s list are Regeneron, Alnylam, Incyte, Syngenta and Biocon.   ]]> <![CDATA[Exalta launches mini ventilator with oxygen concentrator]]> https://biospectrumindia.com/news/95/17500/exalta-launches-mini-ventilator-with-oxygen-concentrator.html https://biospectrumindia.com/news/95/17500/exalta-launches-mini-ventilator-with-oxygen-concentrator.html Fri, 30 Oct 2020 10:55:00 +0530 Since the global outbreak of the novel coronavirus, the major concern for people was respiratory illness due to decreasing oxygen levels as the virus directly impacts the lungs of an individual. In a bid to help people tackle this concern, New Delhi based Exalta has developed a portable mini ventilator with inbuilt oxygen concentrator. A water-based pure oxygen concentrator, the mini ventilator provides 200mm hg of oxygen per minute. All that one needs to do is put water inside the ventilator and rest it’ll process on its own. It creates pure oxygen through the water like other different oxygen concentrators found in the market that are based on Normal PSA (Pressure Swing Adsorption). They consist of Pressure exhaust mechanism that draws oxygen from normal air with zeolite process. Zeolite is the process that purifies the air and removes other gases into a compressor. An effective way to process oxygen through water, consumption of this air for 15 minutes, shows increase in oxygen level, flow rate, P.I. (Perfusion Index) level, and other functions in the body. It also helps in treating health problems like Alzheimer's, Diabetes, toxicity, among others. Speaking about the launch Monika Singh, Director Exalta, said, “This product works as an Oxygen concentrator, Compressed Oxygen, and Mini Ventilator which is 100% made in India with no foreign components used. We’re calling it a Mini Ventilator because it can provide you the oxygen at the pressure of 200mm Hg to the lungs. Which can act as a ventilator at your home. It’s portable, handy, and easy to carry.”   ]]> <![CDATA[Dr Reddy’s teams up with BIRAC for advisory on Sputnik V trials]]> https://biospectrumindia.com/news/95/17494/dr-reddys-teams-up-with-birac-for-advisory-on-sputnik-v-trials.html https://biospectrumindia.com/news/95/17494/dr-reddys-teams-up-with-birac-for-advisory-on-sputnik-v-trials.html Thu, 29 Oct 2020 13:25:00 +0530 Dr Reddy’s Laboratories has announced its partnership with Biotechnology Industry Research Assistance Council (BIRAC), Department of Biotechnology (DBT), Government of India, for advisory support on clinical trials of Sputnik V vaccine in India. The partnership will allow Dr Reddy’s to identify and use some of BIRAC’s clinical trial centres for the vaccine, which are funded under the National Biopharma Mission (NBM), implemented by Project Management Unit-NBM at BIRAC. Further, the Company will have access to Good Clinical Laboratory Practice (GCLP) labs to conduct immunogenicity assay testing of the vaccine. Satish Reddy, Chairman, Dr Reddy’s Laboratories said, “We are pleased with the collaboration with BIRAC as an advisory partner for clinical trials of the Sputnik V vaccine in India. We look forward to working with them to accelerate our efforts in bringing the vaccine to India.” Commenting on the collaboration with Dr Reddy’s, Dr Renu Swarup, Secretary, DBT and Chairperson, BIRAC said, "The government is committed to fast track clinical development of COVID vaccine candidates and provide facilitation to accelerate market readiness of a suitable vaccine. We at DBT look forward to this partnership with Dr Reddy’s for this Indo Russian Collaboration for Vaccine Development."  Earlier this month, Dr Reddy’s and Russia Direct Investment Fund (RDIF) received approval from the Drugs Controller General of India (DCGI) to conduct an adaptive phase 2/3 human clinical trial for Sputnik V vaccine in India. On August 11, 2020, the Sputnik V vaccine developed by the Gamaleya National Research Institute of Epidemiology and Microbiology was registered by the Ministry of Health of Russia and became the World’s first registered vaccine against COVID-19 based on the human adenoviral vector platform.   ]]> <![CDATA[HCL launches mental health helpline in Madurai]]> https://biospectrumindia.com/news/95/17492/hcl-launches-mental-health-helpline-in-madurai.html https://biospectrumindia.com/news/95/17492/hcl-launches-mental-health-helpline-in-madurai.html Thu, 29 Oct 2020 01:05:00 +0530 HCL Foundation, the Corporate social responsibility (CSR) arm of HCL Technologies, multinational information technology services and consulting company headquartered in Noida, have launched mental health helpline in Madurai to support the students in distress and in need of any psychosocial support, in a much more streamlined and an effective manner. HCL Foundation is supporting the Happy Schooling Project, which is being implemented in Madurai among the 24 Corporation run schools since 2017-18. The project has helped in building a strong teacher student bond and has created a conducive and happy environment for students. It is being technically supported by NIMHANS, Bangalore and detailed curriculum has been set on mental health literacy. With the support of Madurai Corporation, the project is now launching a helpline which would support the students in distress and in need of any psychosocial support, in a much more streamlined and an effective manner. The project has reached out to 11,253 students and more than 250 teachers in the last three years. More than 50 teachers have been identified, along with the school heads, who will be trained through a six-day intensive training program for providing psychosocial support and to develop the competencies in providing counselling to the students in need. The training with further help them understand the use of the available referral network. A four-tier mental health literacy session is conducted with the Heads of the schools; Teachers; Parents and the Students themselves, to exclusively focus on the Mental wellbeing of the students.   ]]> <![CDATA[Wellthy Therapeutics, ManipalCigna collaborates to present Proheal]]> https://biospectrumindia.com/news/95/17490/wellthy-therapeutics-manipalcigna-collaborates-to-present-proheal.html https://biospectrumindia.com/news/95/17490/wellthy-therapeutics-manipalcigna-collaborates-to-present-proheal.html Thu, 29 Oct 2020 00:00:00 +0530 Mumbai-based startup Wellthy therapeutics has recently collaborated with ManipalCigna, to present Proheal, a wellness programme, to manage chronic illness and boost better health outcomes. The program can be availed by the existing as well as new policyholders of the Pro Health Insurance Plan. Proheal is designed with an objective to boost medical monitoring and encourage adherence to ongoing medication, the two crucial aspects to handle chronic conditions. Covering a realm of chronic conditions including diabetes, hypertension, Cardiovascular Diseases, obesity, and Dyslipidemia, ProHeal aims at sensitizing the policyholders about the importance and the role of medication adherence in combating chronic conditions and reducing incidences of hospitalizations. The combination of digital therapeutics and insurance offers a holistic healthcare plan for the beneficiaries. The suggestions and advice would include important factors like monitoring daily diet, exercise regime, stress-management, sugar and HB levels, and more.   At the renewal of the policy, the reports and medical adherence followed by the beneficiary will be assessed and basis the comparison of desired and achieved outcome, a discount on the policy renewal will be considered.   ]]> <![CDATA[Sesderma launches Lactyferrin nasal spray plus to beat COVID-19]]> https://biospectrumindia.com/news/95/17486/sesderma-launches-lactyferrin-nasal-spray-plus-to-beat-covid-19.html https://biospectrumindia.com/news/95/17486/sesderma-launches-lactyferrin-nasal-spray-plus-to-beat-covid-19.html Wed, 28 Oct 2020 16:05:00 +0530 Coronavirus continues to threaten the world, and the number of affected people continues to grow. Faced with this situation, Dr Gabriel Serrano, dermatologist and pioneer in lactoferrin research, is increasing his efforts to contribute to people’s health and wellbeing through different initiatives. Among them is the development of a complete line of products containing liposomal lactoferrin. In a virtual conference held on Wednesday 28th Oct 2020, Dr Gabriel Serrano, founder of Sesderma, Spain announced the launch of Lactyferrin Nasal Spray Plus in India for the prevention and treatment of Covid-19. The encapsulation of lactoferrin in liposomes increases its effectiveness in the target cell and increases its stability over time. Studies indicate that the main mode of transmission for Covid-19 continues to be the droplets exhaled through the airways when coughing, sneezing, singing, or speaking. These droplets may reach the mouth or nose of those nearby and end up in their lungs.  The latest launch to block the entry of the virus is Lactyferrin Defense Plus Nasal Spray, which strengthens the natural barrier of the airways thanks to its formula with liposomal lactoferrin. Dr Gabriel Serrano, a dermatologist with over 45 years of professional experience, has carried out several studies on the usefulness of lactoferrin in the prevention and treatment of Covid-19-affected patients. Lactoferrin is a milk-derived multifunctional protein, although it is also present in mucous secretions (tears and saliva, among others). Thus, the extensive studies performed conclude that lactoferrin forms part of the organism’s natural shield, and plays a very important role in innate immunity. ]]> <![CDATA[Medihauxe Pharma gears up to distribute COVID-19 vaccine]]> https://biospectrumindia.com/news/95/17480/medihauxe-pharma-gears-up-to-distribute-covid-19-vaccine.html https://biospectrumindia.com/news/95/17480/medihauxe-pharma-gears-up-to-distribute-covid-19-vaccine.html Tue, 27 Oct 2020 16:50:00 +0530 Amidst the buzz around an imminent COVID-19 vaccine to be available in near future, Hyderabad-based Medihauxe Pharma has announced that it is fully geared up to handle, store and distribute Corona Vaccine in both Telugu states as and when the vaccine is made available.  A vaccine’s journey can be risky with underdeveloped infrastructure. If there’s a break in the cold chain as a vaccine has to be taken to many places, it will lose its potency. And the entire purpose is defeated. “We have experience and expertise in handling temperature sensitive specialty medicine and Cold Chain Pharma Products, their storage and handling declares, Girish Bhat and P Manohar, MD and Director, Medihauxe Pharma. Our facility is the state-of-the-art one and the warehouse infrastructure is one of the best in the country. We equipped with the latest technology, coupled with time-tested systems, agile management to ensure world class service,” they added. The first-ever, temperature-sensitive medicine cooling facility, 2-8 degrees, at distribution level has all the requisite infrastructure such as Cold Chain, Walk-in-Cold Rooms, Data Loggers, informed Bhat. Medihauxe Pharma currently deals with medicine categories such as cancer; liver, lung, kidney and cardiac transplants. Its facilities are audited by international pharma majors. The currently the turnover of the company is Rs 180 crore and has 120 employees.       ]]> <![CDATA[Piramal Pharma launches multi-surfaces disinfectant effective against COVID-19]]> https://biospectrumindia.com/news/95/17474/piramal-pharma-launches-multi-surfaces-disinfectant-effective-against-covid-19.html https://biospectrumindia.com/news/95/17474/piramal-pharma-launches-multi-surfaces-disinfectant-effective-against-covid-19.html Tue, 27 Oct 2020 13:00:00 +0530 Piramal Pharma Limited’s Consumer Products Division has announced that its Tri-Activ Disinfectant Spray for multi-surfaces is ’99.9 per cent effective against the COVID-19 virus in one minute'. This spray has been tested and proven for efficacy as well as fast action on the COVID-19 virus by an independent accredited US-based lab. The Tri-Activ Disinfectant Spray can be used to disinfect a variety of hard and soft surfaces including delivery parcels, non-leather car interiors and shoes, glass table tops, door handles and knobs, lift buttons, children’s toys and cycles, and non-satin clothes, sofas, curtains and mattresses. Its regular usage also keeps fungus and mould away from high touch surfaces. This spray is available in three pack sizes – 100ml (convenient to carry), 230ml (medium) and 500ml (large) at affordable prices. Nandini Piramal, Director, Piramal Pharma Limited said, “With the threat of COVID-19 and the uncertainty around it, the demand for sanitisation and disinfectant products is on a significant rise as personal hygiene and environment sanitisation is of paramount importance. Piramal’s Consumer Products Division launched the Tri-Active range of products with an aim to provide complete protection to its consumers by catering to their various personal and household needs. Committed to our purpose of Doing Well and Doing Good, we’re now enabling more consumers to make their world ‘Tri-Activ’ safe.” Piramal’s Consumer Products Division recently launched its disinfectant product portfolio under the brand name Tri-Activ in Q1 FY2021. The products under this portfolio offer customers a complete range of protection from virus, bacteria and other germs. In addition to having adopted a WHO approved hand sanitiser liquid, this range comprises a variety of products including disinfectant spray, hand sanitiser gel, multi-purpose disinfectant liquid, as well as a 6-layer protective face mask with an anti-virus coating. Adopting an e-commerce first strategy, the complete Tri-Activ range of products is available across all major sales channels including general trade, modern trade and leading e-commerce platforms. Tri-Activ sprays and sanitisers are available at 50,000+ outlets in 177 towns in India across chemist and non-chemist channels. ]]> <![CDATA[DENTTABS arrives in India with toothpaste tablets]]> https://biospectrumindia.com/news/95/17469/denttabs-arrives-in-india-with-toothpaste-tablets.html https://biospectrumindia.com/news/95/17469/denttabs-arrives-in-india-with-toothpaste-tablets.html Mon, 26 Oct 2020 17:35:00 +0530 DENTTABS is delighted to announce its arrival in the Indian market, thereby paving way for the much needed sustainable brushing practices in India. Founded in Berlin, Germany, DENTTABS Toothpaste Tablets are the sustainable alternative to the conventional toothpaste as the brand offers its products in the form of toothpaste tablets composed of 100 per cent natural ingredients, vegan, free from plastic, artificial stabilisers or any other form of preservatives. Unlike the regular toothpastes, DENTTABS Toothpaste Tablets do not require any deleterious stabilisers and additives due to its solid tablet form that has no water in its composition. The distinctive fluoride properties of DENTTABS Toothpaste Tablets also help to prevent decay and revitalise the aching tooth necks. Owing to such natural, ecological and resource-frugal practices, the brand also takes pride in its BDIH-COSMOS certification. DENTTABS Toothpaste Tablets are not merely an organic way to maintain oral hygiene, but also functions as a tool to protect the environment as its packaging material is based on cornstarch laminated with paper, designed for industrial compost. Pragya Kapoor, a phenomenal producer, a loving mother of two and an avid conservationist with colossal zeal for sustainability and eco-friendly practices has been appointed as the face of DENTTABS brand in India. Pragya’s personal values strongly resonate with what the brand stands for, she is immensely delighted to represent DENTTABS in the Indian market. “DENTTABs reinvented the idea of dental care for me” says Pragya Kapoor. With just three simple steps, Bite-Chew, Brush-Polish and Rinse-Done, DENTTABS Toothpaste Tablets leave your teeth with a natural glow, smoothness and a refreshing feeling to start your day happy, healthy and enjoy the long lasting freshness through the day! The product portfolio offers customers the option of using the tablets with or without fluoride depending on their preferences. The brand also offers bamboo toothbrushes whose soft and supple Nylon 6 bristles make it possible to tenderly clean the inter-tooth spaces whilst polishing the enamel. The brand sells its products online through its own webshop and also in select sustainable e-com market places, zero waste shops in select cities in India. ]]> <![CDATA[Sai Life Sciences to expand biology capabilities at R&D campus ]]> https://biospectrumindia.com/news/95/17467/sai-life-sciences-to-expand-biology-capabilities-at-rd-campus-.html https://biospectrumindia.com/news/95/17467/sai-life-sciences-to-expand-biology-capabilities-at-rd-campus-.html Mon, 26 Oct 2020 16:55:00 +0530 Sai Life Sciences, one of India's fastest growing Contract Research, Development & Manufacturing (CRDMO), has recently announced plans to significantly expand its biology capabilities at its integrated R&D campus in Hyderabad, India with a dedicated 75,000 sq. ft. facility and an augmented team of 170 biologists. The new facility will house expanded in vitro and in vivo biology services, DMPK and toxicology capabilities with the first set of labs scheduled to open in March 2021. Sai Life Sciences has been steadily growing its biology capabilities to complement its strong foundation in medicinal chemistry, DMPK and toxicology for supporting its customers across the entire drug discovery journey from target ID and validation to IND. Last year, the company opened its first international R&D facility with a biology lab in Boston, USA. The Boston Biology Lab is designed to offer start-up and biotech companies in the region biology services to address exploratory and custom biology needs.  The company's discovery services support a wide range of global innovator companies from start-ups to large pharma companies, across a diverse set of therapeutic areas including oncology, CNS, antivirals, and inflammation among others. With a strong track record of enduring customer relationships averaging 10+ years, Sai Life Sciences has advanced 25+ programs to different clinical phases (IND to Phase-III) with the average turnaround time from Hit/Lead to Candidate being 18 months. Sai Life Sciences began a process of organizational transformation in 2019, through the Sai Nxt initiative, reinventing itself as a new generation global CRO/CDMO.   ]]> <![CDATA[BenQ Materials introduces acne patch in India ]]> https://biospectrumindia.com/news/95/17466/benq-materials-introduces-acne-patch-in-india-.html https://biospectrumindia.com/news/95/17466/benq-materials-introduces-acne-patch-in-india-.html Mon, 26 Oct 2020 16:40:00 +0530 After making waves in ASEAN countries, BenQ Materials Corp, leaders in the field of material science, have launched their multifunctional & powerful numero uno acne patch in Indian Market.  The country's first officially registered acne patch, both for men and women, will be marketed and distributed in India by KShipra Health Solutions. It is available in two variants -- Day Acne Patch and Night Acne Patch. While the ultra-thin Day patch conforms to any contour of the face, making acne highly invisible and working effectively for 12 hours, the Night acne patch is slightly bigger and thicker in the middle so that it absorbs pus all night. DermaAngel's Acne Patches have not one or two but three USPs - Invisibility, Anti-Acne and Protection. The wafer-thin translucent material ensures the patch is discreet and blends with the natural skin tone. It is makeup friendly too. Where else would you find hydrocolloid material on the inside effectively absorbing the exudate while protecting the wound from bacteria and other infections and reducing the chances of scarring. Meeting consumers' expectation backed by innovation is the need of the hour, feels Dr ZC Chen, Chairman & CEO - BenQ Materials. "With DermaAngel Acne patch, we will definitely revolutionise the skincare market in India," he said. He further added, "The company expects to hold a major percentage of the acne market in India over the next two-three years. In upcoming months, DermaAngel will be introducing other products from its skincare range." Talking about DermaAngel Acne Patch, Utpal Lomesh Limkar, Director, Kshipra Health Solutions shares the product is the most effective way to manage acne. "Skincare experts who understand skin best will promote/ recommend these acne patches. They are the right set of people to guide you on acne and how to prevent as well as manage it. Thankfully, these patches will be available at most dermatology clinics so you don't have to hunt them down," he puts in. "Once we are able to inculcate right knowledge among the consumers, in the second phase we will make the product available online on e-commerce portal," he further added. ]]> <![CDATA[Cadila Pharma, ISCR focus on innovation via pharmacoeconomics]]> https://biospectrumindia.com/news/95/17464/cadila-pharma-iscr-focus-on-innovation-via-pharmacoeconomics.html https://biospectrumindia.com/news/95/17464/cadila-pharma-iscr-focus-on-innovation-via-pharmacoeconomics.html Mon, 26 Oct 2020 12:40:00 +0530 Cadila Pharmaceuticals in association with the Indian Society for Clinical Research (ISCR) organized a webinar on “Pharmacoeconomics in Drug development and medicine accessibility on 18th October 2020 which saw the participation from some of the industry leaders from DCGI, ISCR, and international academicians. The session was a mix of industry and academic insights that talked about Pharmacoeconomics, role of Pharmacoeconomics in innovative drug development and Pharmacoeconomics as a tool to enable medicine accessibility.  The session saw the participation from - Dr Rubina Bose, Deputy DCGI, Dr Sanish Davis, General Secretary of Indian Society for Clinical Research (ISCR), Dr Subhrojyoti Bhowmick, Clinical Director, Peerless Hospital, Dr Amogh Dev Rai, Executive Director, Sanrachna, Dr Bakulesh Khamar, Executive Director-R&D at Cadila Pharmaceuticals Ltd. and Prof (Dr) Marcin Czech, Head of the dept. of Pharmacoeconomics, Institute of Mother and Child, Warsaw and ex-Deputy Minister of Health, Government of Poland who was the keynote speaker. “To achieve the public health objectives of national and global government, we need a strong regulatory system. In case of an inefficient regulatory system, it becomes a barrier to making quality and affordable medicines available to all” said Dr Rubina Bose, Deputy DCGI on the relevance of regulatory systems in the current scenario. “Pharmacoeconomics helps us make an informed decision regarding the appropriate use of drugs. It helps us make the best use of limited resources and extend quality healthcare to maximum people” Dr Subhrojyoti Bhowmick, Clinical Director, Peerless Hospital shared. “ISCR is always working towards innovation and I am grateful to be a part of this conclave to ideate more on working towards affordable healthcare for all” shared Dr Sanish Davis, General Secretary of Indian Society for Clinical Research (ISCR). “Pricing of drugs is an important factor for any country’s pharmaceutical industry. But we as a country need a clear strategy and need to learn from global industries, to move forward” shared Amogh Rai, Executive Director, Sanrachna. “Pharmacoeconomics plays an important role in innovative drug development. It helps with health-care policy decisions, provides guidance for funding of projects and creates demand/awareness. This collectively will enable the pharma organizations to provide innovative drugs at an affordable price” shared Dr Bakulesh Khamar, Executive director, Cadila Pharmaceuticals Ltd. “Globally, there is a limited budget for drugs. With Pharmacoeconomics, we want to enable the pharmaceutical industries to focus more on innovation while keeping the pricing in check” shared Prof (Dr) Marcin Czech, Head of the Dept. of Pharmacoeconomics, Institute of Mother and Child, Warsaw and ex-Deputy Minister of Health, Government of Poland. The session concluded with an engaging question and answer round where doctors and viewers talked about the future of Pharmacoeconomics and how can it change the landscape of the pharma industry. The session can be viewed here (https://www.facebook.com/officialcadilapharma/videos/353393889110743/). “Around 200 participants across India, Nepal & Sri Lanka joined as attendees in this insightful webinar. Apart from this lot of industry people and research aspirants were part of this event via Facebook live” said Snehendu Konar, one of the executives of organizing committee of this particular event. ]]> <![CDATA[Intexso launches anti bacterial & anti viral face masks]]> https://biospectrumindia.com/news/95/17454/intexso-launchesanti-bacterial-anti-viral-face-masks.html https://biospectrumindia.com/news/95/17454/intexso-launchesanti-bacterial-anti-viral-face-masks.html Mon, 26 Oct 2020 00:00:00 +0530 Intexso Biochem, based in Mumbai, has recently launched the TexsoGuard anti-viral and anti-bacterial face masks powered by HeiQ Viroblock NPJ03 and HeiQ Smart Temp. Intexso is the sole distributor of HeiQ products throughout India. While the HeiQ Viroblock NPJ03 is among the first textile technologies in the world to be tested successfully against SARS-CoV-2, the COVID-19 causing virus, HeiQ Smart Temp is a patented technology based on hydro-functional polymer, adding to the fabric the ability to response to the temperature change in the surrounding and activate a dynamic evaporative cooling property. The TexsoGuard face masks have been launched in two varieties namely, Premium and Classic. The Premium mask is made up of special fabrics, like dope dyed polyester on the outer layer and super soft Modal fabric on the inner layer, while the Classic mask is made of 100 per cent soft cotton knit fabric in both inner and outer layer. While the fibre composition in these two types of masks differ they carry exactly identical protection and the various chemical technologies used in both masks are exactly identical. The outer layer in both masks is treated with HeiQ Viroblock NPJ03 and a water repellent treatment HeiQ Eco Dry. The middle layer is made up of 60gsm SMMS fabric which effectively filters out all kinds of fine dust particles, giving a PFE value of 95 per cent plus. At the same time offering excellent breathability and withstanding repeated washings up to 30 times. The inner layer is once again treated with the HeiQ Viroblock technology as an additional protection point and also with the HeiQ Smart temp technology which keeps the wearer cool and comfortable even when one is wearing the mask for a long period of time at a stretch. Speaking about this, HP Shetty, Director, Intexso Biochem Pvt Ltd said, "We are happy to launch the TexsoGuard face masks treated with the state-of-the-art technologies from HeiQ Materials AG, a leader in textile innovation worldwide.” The TexsoGuard Face Masks are available on Flipkart & Amazon in the pack of 1 at a price of ₹ 250 for the Premium masks and ₹ 180 for the Classic masks. ]]> <![CDATA[Lupin wins five INDIASTAR 2020 awards for excellence in packaging]]> https://biospectrumindia.com/news/95/17460/lupin-wins-five-indiastar-2020-awards-for-excellence-in-packaging.html https://biospectrumindia.com/news/95/17460/lupin-wins-five-indiastar-2020-awards-for-excellence-in-packaging.html Sat, 24 Oct 2020 23:30:00 +0530 Pharma major Lupin Limited (Lupin) based out in Mumbai has recently announced that it has won five ‘INDIASTAR 2020’ awards under the category ‘Excellence in packaging, innovative design, and development’ for its derma products – Novegrow, Lupiaqua cream, Novilite cream, Noviglo face wash and Novishine shampoo. The award was conferred by the Indian Institute of Packaging (IIP). The INDIASTAR Award is a national award for excellence in packaging. A jury of eminent personalities from institutions, government bodies, and industry experts selected the winners from a total of 305 entries. INDIASTAR awards are duly recognized and endorsed by the Asian Packaging Federation (APF) and the World Packaging Organization (WPO). The winning of IIPs’ INDIASTAR award has opened the doors for winners to compete with their awarded designs for International Awards viz. ASIASTAR and WORLDSTAR. Commenting on the win Rajeev Sibal, President – India Region Formulations, Lupin Limited said, “Packaging is a key focus area for us and winning this award is a great honor as it demonstrates our level of commitment to excellence and design while keeping in mind quality, safety and compliance requirements.” ]]> <![CDATA[IAVI, Merck, Serum Institute partner to develop mAbs against COVID-19]]> https://biospectrumindia.com/news/95/17453/iavi-merck-serum-institute-partner-to-develop-mabs-against-covid-19.html https://biospectrumindia.com/news/95/17453/iavi-merck-serum-institute-partner-to-develop-mabs-against-covid-19.html Fri, 23 Oct 2020 17:00:00 +0530 IAVI, a nonprofit scientific research organisation dedicated to addressing urgent, unmet global health challenges, and Serum Institute of India, a leading manufacturer of vaccines and biologics, have announced an agreement with Merck, a leading science and technology company, to develop SARS-CoV-2 neutralising monoclonal antibodies (mAbs) co-invented by IAVI and Scripps Research as innovative interventions to address the COVID-19 pandemic. "We're acutely aware of the tremendous potential for monoclonal antibodies to be used in COVID-19 response,” said Mark Feinberg, President, CEO, IAVI. “I am extremely pleased that we have joined forces with IAVI and Merck in the fight against COVID-19 with the aim of developing monoclonal antibodies for global access,” said Adar Poonawalla, CEO, Serum Institute. Scientists at IAVI’s Neutralising Antibody Center (NAC) based at Scripps Research, along with fellow immunologists at Scripps Research, were part of a team that identified antibodies from the blood of recovered COVID-19 patients that are capable of potently neutralising SARS-CoV-2, the virus that causes COVID-19. Animals that received these neutralising antibodies were protected against disease after challenge with SARS-CoV-2. The results were published in Science in June 2020. Under IAVI’s agreement with Merck and Serum Institute, the partners will conduct an accelerated, integrated programme of preclinical and clinical research to evaluate the antibodies for treatment of COVID-19. A Phase I clinical trial is expected to start early in 2021. Joining the partners in this development effort are two highly regarded companies with unique capabilities. Syngene International Ltd, based in Bengaluru, India, is Asia's largest contract research and manufacturing organisation. Through their innovation-focused research and development capabilities they are a collaborating partner for the development and conduct of assays to support clinical development of the SARS-CoV-2 mAb candidates. ATUM, a California-based bioengineering company, has utilised its Leap-In Transposase® Platform to develop stable cell lines needed for the manufacture of the SARS-CoV-2 antibody candidates being advanced via this collaboration. ]]> <![CDATA[PNB Vesper initiates Ph 2 trials of NCE PNB-001 for COVID-19 treatment]]> https://biospectrumindia.com/news/95/17458/pnb-vesper-initiates-ph-2-trials-of-nce-pnb-001-for-covid-19-treatment.html https://biospectrumindia.com/news/95/17458/pnb-vesper-initiates-ph-2-trials-of-nce-pnb-001-for-covid-19-treatment.html Fri, 23 Oct 2020 01:05:00 +0530 PNB Vesper in Kochi, which had received approval from the Drug Controller General of India (DCGI) last month to conduct Covid-19  Phase 2 Clinical trials of their NEW CHEMICAL ENTITY PNB-001 (GPP-Baladol®), has been given the ethical committee approval to go ahead by the BJ Medical College and  Sasoon General Hospital, Pune, on 14th October. All necessary formalities have been completed with the Government to start the clinical trials in record time.  The first patient, having COVID-19 pneumonia and breathing problems has been administered GPP-Baladol. The principal Investigator of the Study is Dr Pradnya Bhalerao, MBBS, MD, Head, COVID-19 Department, at the medical college.  A group of Doctors from the USA, the UK and India will monitor the studies on a daily basis. The study will be completed in 60 days. The interim efficacy results will be released within 30 days. The effect of PNB 001 will be compared with Dexamethasone, currently the most used medication for COVID-19 treatment. The molecule has already been patented and the related Intellectual Property Rights (IPRs) have been secured by PNB VESPER in the US, Europe and rest of the world. In the Phase 1 clinical trials, GPP Baladol® (PNB-001) was found extremely safe and was tested in 74 healthy humans. Speaking on the breakthrough innovation, P N Balaram, CEO of PNB Vesper Life Science said, “This is indeed a very big step for mankind in its fight against the COVID-19 pandemic. The clinical trials would be completed in 60 days. Considering the novel mechanism of our molecule, we expect better results in the clinical trials, compared with Dexamethasone.  In COVID-19, the main symptoms are Pyrexia, Body Pain and inflammation in the Lung and we lose patients mainly because of Cytokine Storms and ARDS. PNB 001 is found to be effective against all Covid-19 symptoms. PNB 001 is further found to be very effective in Small Cell Lung Cancer.  If the molecule is found to work successfully in Covid-19 patients, PNB 001 may be the first New Chemical Entity in the world for COVID-19 treatment.” ]]> <![CDATA[Bharat Biotech receives DCGI approval for Ph 3 trial of COVID-19 vaccine]]> https://biospectrumindia.com/news/95/17456/bharat-biotech-receives-dcgi-approval-for-ph-3-trial-of-covid-19-vaccine.html https://biospectrumindia.com/news/95/17456/bharat-biotech-receives-dcgi-approval-for-ph-3-trial-of-covid-19-vaccine.html Fri, 23 Oct 2020 00:00:00 +0530 After successful completion of the interim analysis from the Phase 1 & 2 clinical trials of COVAXIN, Hyderabad based Bharat Biotech has received DCGI approval for Phase 3 clinical trials. The phase 3 trial will be conducted in 26,000 participants in over 25 centres across India. COVAXIN, India's indigenous COVID-19 vaccine by Bharat Biotech is developed in collaboration with the Indian Council of Medical Research (ICMR) - National Institute of Virology (NIV). The indigenous, inactivated vaccine is developed and manufactured in Bharat Biotech's BSL-3 (Bio-Safety Level 3) high containment facility. ]]> <![CDATA[Dr Reddy's shuts services post cyber attack]]> https://biospectrumindia.com/news/95/17445/dr-reddys-shuts-services-post-cyber-attack.html https://biospectrumindia.com/news/95/17445/dr-reddys-shuts-services-post-cyber-attack.html Thu, 22 Oct 2020 23:00:00 +0530 Recently in the new for receiving the approval from the Drug Control General of India (DCGI) to conduct an adaptive phase 2/3 human clinical trial for Sputnik V vaccine in India, Hyderabad based Dr Reddy's has become a victim of a mega data breach. Due to a ransomware attack on 22 October on its IT systems, the company has shut down all its servers. "In the wake of a detected cyber-attack, we have isolated all data center services to take required preventive actions", stated Dr Reddy's soon after the incident occured. Commenting on this development, Mukesh Rathi, CIO, Dr. Reddy’s Laboratories said, “We are anticipating all services to be up within 24 hours and we do not foresee any major impact on our operations due to this incident.” Although the reason behind this attack is unknown, it is likely that the target is the COVID-19 vaccine development data. Similar incidents of cyberattacks have been reported by a few Japanese research institutes last week. As a result, the National Center of Incident Readiness and Strategy for Cybersecurity (NISC), a Japanese government body that establishes standards for cybersecurity for government agencies, has urged companies to raise alert levels against such attempts to steal confidential information ]]> <![CDATA[UniMask partners with Wellness Forever to expand product reach]]> https://biospectrumindia.com/news/95/17442/unimask-partners-with-wellness-forever-to-expand-product-reach.html https://biospectrumindia.com/news/95/17442/unimask-partners-with-wellness-forever-to-expand-product-reach.html Thu, 22 Oct 2020 17:10:00 +0530 Ahead of the festival season, UniMask – a leading brand of antiviral treated mask; tested to kill 99.94 per cent virus within seconds of contact has collaborated with Wellness Forever – a leading pharmacy chain in western India. With this move, the revolutionary Antiviral Masks from the house of UniMask is now present in 200+ Wellness Forever stores. They are also available on online platforms like Amazon, Flipkart and on their website www.unimask.in Backed by Uniform Republic, an over two decade old company in the garment industry, these masks under the brand name of ‘UniMask’ is made from 100 per cent breathable cotton fabric with anti-viral treatment on the fabric. These masks are made with health-guard technology from Australia which is known for destroying 99.94 per cent of the virus like SARS-CoV-2, H1N1and other harmful viruses within minutes of coming in contact with the fabric. With this partnership people will get access to UniMask across 200+ Wellness Forever stores present in western India. Speaking on this new collaboration, Kapil Bhatia, CEO, UniMask, said, “We are extremely delighted to associate with a reputed brand like Wellness Forever. The primary reason behind this collaboration is to expand our product reach and cater to the demand of the maximum number of households as we can. Being associated with a well-known pharmacy chain like Wellness Forever will further add value to our products.” At present, UniMask has a range of adult face masks as a part of their product line-up. The brand further aims at expanding its product portfolio with kids face masks very soon along with a new line of products in the similar category. UniMask is also tying up with large corporates, banks and financial institutions for their festive offerings. ]]> <![CDATA[Comofi Medtech develops novel transparent NT masks]]> https://biospectrumindia.com/news/95/17439/comofi-medtech-develops-novel-transparent-nt-masks.html https://biospectrumindia.com/news/95/17439/comofi-medtech-develops-novel-transparent-nt-masks.html Thu, 22 Oct 2020 15:10:00 +0530 Face masks have become an indispensable part of our daily lives. On streets, in shops and on public transport, wearing masks has become compulsory in many nations, not just India. But when it comes to healthcare professionals, they have to interact with patients on a daily basis, without masks, whether or not they are suffering from the disease. In fact, thousands of healthcare professionals have lost their lives since this crisis took shape - and probably the most dominant reason was sample collection, where the healthcare professionals had no choice but to remove the patients’ face mask and conduct swab collection. With support from Department of Science & Technology, and KIIT technology business incubator under the CAWACH programme, Bengaluru based Comofi Medtech has launched two variations of N-95 transparent masks - also known as NT masks. Built with the best interests of the healthcare workers in mind, the NT Mask from Comofi Medtech effectively eliminates their droplet exposure while conducting tests or during treatment. The NT Mask also comes with a unique access window that enables swab collection or endoscopic treatments without the patient requiring to remove their face mask. And with a unique, breathable fabric-based construction, these masks are anti-fogging for better visibility. In terms of protection, the company claims that these masks offer 99.9 per cent bacterial filtration efficiency which is even better than N-95 masks. According to Dr Satish Kalme, Founder, CEO, Comofi Medtech, “While our NT masks offer better breathability and purification than N95 masks, our goal is to make it easily available for the underprivileged communities. With considerable support from the local government in procuring raw materials and setting up manufacturing, today we have a production capacity of 2000 NT masks per day.” To date, Comofi Medtech has donated over 10,000 masks across Gujarat, Maharashtra, Tamil Nadu, along with some tribal runs. In the long run, the company plans to donate over 32,000 masks to healthcare workers and the community. ]]> <![CDATA[BDR Pharma launches cost effective drug for cancer patients]]> https://biospectrumindia.com/news/95/17434/bdr-pharma-launches-cost-effective-drug-for-cancer-patients.html https://biospectrumindia.com/news/95/17434/bdr-pharma-launches-cost-effective-drug-for-cancer-patients.html Wed, 21 Oct 2020 18:20:00 +0530 BDR Pharmaceutical has announced the launch of 4mg and 10 mg of Lenvatinib under the brand name BDFOIE for the treatment of differentiated thyroid cancer, advanced liver cancer and advanced kidney cancer.  Lenvatinib is priced at Rs 1620 (4 mg) and Rs 2970 (10 mg) for a pack of 10 capsules. Lenvatinib is a molecule used to provide breakthrough therapy treatment for cancer patients. The results of clinical trials conducted showed encouraging results with safety and efficacy on patients treated with aggressive tumors. Dharmesh Shah, CMD, BDR Pharmaceuticals, Mumbai said, “2020 so far has been extraordinary on an operational front. By launching cost-effective therapy options, we want to mitigate the challenges faced by Indian patients in seeking access to treatment and finding a timely cure for life-threatening diseases. The launch of Lenvatinib is a step forward in providing breakthrough treatment options at an affordable price, reducing the average cost of treatment drastically.” ]]> <![CDATA[Excelra to develop GOSTAR for drug target identification ]]> https://biospectrumindia.com/news/95/17431/excelra-to-develop-gostar-for-drug-target-identification-.html https://biospectrumindia.com/news/95/17431/excelra-to-develop-gostar-for-drug-target-identification-.html Wed, 21 Oct 2020 11:20:00 +0530 Hyderabad-based Excelra a leading global Data & Analytics organization has recently announced that it has licensed its Global Online Structure Activity Relationship Database (GOSTAR) to Cyclica Inc., a leading biotechnology company based in Toronto whose AI-augmented integrated platform enables multi-objective, polypharmacology-informed design of drug molecules. GOSTAR is the largest online structure-activity relationship database comprising of over 5.5 million small molecules and their associated chemical, biological and pharmacological properties. The database is manually curated by our scientific team who excerpt and enrich datasets from functional assays, in vitro and in vivo studies. A variety of small molecule activities encompassing SAR, physicochemical, metabolic, ADME and toxicological profiles are captured and structured into a relational database. GOSTAR ultimately equips researchers with insights to generate novel ideas in drug design in the early as well as optimization stages of drug discovery. Dr Raveendra Dayam, Director, Chemistry Services, Excelra said: "GOSTAR provides access to more than 28 million experimentally determined quantitative interactions between small molecules and the vast druggable target space. Insights derived from these interactions complement Cyclica's polypharmacology approach in novel compound drug discovery. GOSTAR is a rich qualitative and quantitative dataset that is applied by many AI/ML companies and we are excited that the data will support Cyclica with its predictive analytics." ]]> <![CDATA[Excelra licenses drug discovery database to Canadian firm]]> https://biospectrumindia.com/news/95/17429/excelra-licenses-drug-discovery-database-to-canadian-firm.html https://biospectrumindia.com/news/95/17429/excelra-licenses-drug-discovery-database-to-canadian-firm.html Wed, 21 Oct 2020 00:00:00 +0530 Excelra, a global data & analytics organization based in Hyderabad, has announced that it has licensed its Global Online Structure Activity Relationship Database (GOSTAR) to Toronto based Cyclica Inc., a leading biotechnology company whose AI-augmented integrated platform enables multi-objective, polypharmacology-informed design of drug molecules. GOSTAR is the largest online structure activity relationship database comprising of over 5.5 million small molecules and their associated chemical, biological and pharmacological properties. The database is manually curated by our scientific team who excerpt and enrich datasets from functional assays, in vitro and in vivo studies. A variety of small molecule activities encompassing SAR, physicochemical, metabolic, ADME and toxicological profiles are captured and structured into a relational database. GOSTAR ultimately equips researchers with insights to generate novel ideas in drug design in the early as well as optimization stages of drug discovery. Dr. Raveendra Dayam, Director, Chemistry Services, Excelra said: "GOSTAR provides access to more than 28 million experimentally determined quantitative interactions between small molecules and the vast druggable target space. Insights derived from these interactions complement Cyclica's polypharmacology approach in novel compound drug discovery. GOSTAR is a rich qualitative and quantitative dataset that is applied by many AI/ML companies and we are excited that the data will support Cyclica with its predictive analytics." The breadth of data provided by GOSTAR will broaden the domain of applicability of Cyclica's models, as Dr. Stephen MacKinnon, VP of R&D at Cyclica indicates: "The collaboration with GOSTAR strengthens Cyclica's training data for our platform models by allowing Cyclica to annotate our proteome screening data, thus enhancing our predicted interaction capabilities. This will have a direct impact on the development of more precise and efficacious medicines for patients in need." ]]> <![CDATA[Divoc set to launch 20 telemedicine labs by 2021]]> https://biospectrumindia.com/news/95/17427/divoc-set-to-launch-20-telemedicine-labs-by-2021.html https://biospectrumindia.com/news/95/17427/divoc-set-to-launch-20-telemedicine-labs-by-2021.html Tue, 20 Oct 2020 17:25:00 +0530 With a mission to create the most advanced digital diagnostic laboratory network enabling the connected world and to provide telemedicine and instant care, DIVOC Health launched its first, one-of-a-kind, technologically advanced DIVOC Laboratories in New Delhi in August 2020. Within a month of its establishment, DIVOC Lab in New Delhi has over 100 patients each day and aims to be of assistance to 500-600 patients daily by the next 90 days. The laboratory has already been accredited by NABL and ICMR and have all tests and diagnosis available including COVID-19. Now successfully operational and gaining trust of many, DIVOC Labs is all set to expand its footprints in India. DIVOC Wellness sponsored by Venture Capitalist Impact Financing from London, England. They are preparing to open 20 labs across Tier II and Tier III cities like Lucknow, Bhopal and Jaipur, etc. The focus of the expansion will be on developing more number of ‘Labs of the Future’ where patients have access to instant diagnosis and results at the doorstep within minutes. This will support the growing demand for high-level testing in India and empower the telemedicine segment in faster patient care. Dr Kanav Kahol, CEO, DIVOC Health, says, “We are working on a unique platform that will allow phlebotomists to double their income. We aim to provide a modern, quality driven digital approach to laboratory operations that facilitate consumers with unprecedented reliability, convenience, and impactful innovations.” DIVOC Lab has setup a state of the art facility in Okhla, New Delhi which can enable a variety of testing. The lab of the future has collaborated with United Kingdom laboratories to bring 21st century innovations into diagnostics. It offers Clinical Chemistry, Clinical Microbiology, Haematology, Serology, Clinical Microscopy, Cytopathology and Molecular Biology. It also offers TRUNAAT, RT PCR and Antigen COVID Testing pending ICMR notifications and approvals. DIVOC Laboratories, formed by leading global health experts and practitioners, envisions enabling a digitally empowered integrated approach to diagnostics. It has also introduced at-home, instant diagnostics which would allow phlebotomists to conduct testing and deliver results right away.   ]]> <![CDATA[Cipla launches Nintib to treat idiopathic pulmonary fibrosis]]> https://biospectrumindia.com/news/95/17426/cipla-launches-nintib-to-treat-idiopathic-pulmonary-fibrosis.html https://biospectrumindia.com/news/95/17426/cipla-launches-nintib-to-treat-idiopathic-pulmonary-fibrosis.html Tue, 20 Oct 2020 17:00:00 +0530 Cipla has announced that it has launched generic Nintedanib for the treatment of idiopathic pulmonary fibrosis (IPF). Available as 100 mg and 150 mg capsules, it will be marketed under the brand name Nintib. This launch marks yet another milestone in Mumbai based company’s decade-long commitment to treat IPF, a rare lung disease that impacts ten in one lakh people. Cipla’s journey in IPF began in 2010 with the introduction of Pirfenex, the world’s first generic Pirfenidone and the first ever approved drug for IPF in India. Further to this, Cipla reduced the cost of its IPF therapy by 40 per cent in 2013 to provide patient-access to this critical treatment. In line with its endeavour of enabling effective and affordable management of IPF, Cipla’s Nintib is priced at Rs 69  (100 mg) and Rs 85  (150 mg) per capsule. IPF is a chronic progressive form of lung disease with an average survival rate of three to five years if left untreated. It is characterised by scarring in the lungs, wherein the lung tissue becomes stiff and thick. This interferes with a person's ability to breathe and reduces oxygen supply to the blood, resulting in shortness of breath. Over the past ten years, Cipla has played a pivotal role in creating awareness on the diagnosis and treatment of IPF amongst the medical fraternity. ]]> <![CDATA[OZiva launches HerBones to strengthen bones, support healthier joints, prevent calcium loss in women ]]> https://biospectrumindia.com/news/95/17422/oziva-launches-herbones-to-strengthen-bones-support-healthier-joints-prevent-calcium-loss-in-women-.html https://biospectrumindia.com/news/95/17422/oziva-launches-herbones-to-strengthen-bones-support-healthier-joints-prevent-calcium-loss-in-women-.html Tue, 20 Oct 2020 14:10:00 +0530 In line with raising bone-health awareness on the occasion of World Arthritis Day, OZiva, India’s leading clean plant-based nutrition brand, launched HerBones. The product features a remarkable array of 100 per cent plant based and vegan ingredients that aim to strengthen bones, support healthier joints and prevent calcium loss in women by maintaining optimum hormonal balance in women. HerBones is targeted towards women aged 25 years and above with potential calcium deficiency.   OZiva HerBones, the plant-based nutritional supplement, provides 420 mg Calcium in elemental form that has three times higher absorption rate as compared to rock and synthetic calcium. It is also fortified with 400 IU of Vitamin D3, 40 mcg Vitamin K2-MK7, 12 mg Vitamin C that is naturally sourced from Lichen, flower oil extract, and Acerola Cherry, respectively. What makes OZiva HerBones even more better is its 100 per cent clean and plant based ingredients unlike other supplements available in the market. It also contains naturally-occurring substances that enhance calcium absorption and bone power. It is packed with essential bone-strengthening elements such as calcium, magnesium, and boron from Lithothamnium Calcareum - a marine algae, which is well-endowed with necessary properties that boost bone structure and function.  Speaking on the novel product launch, Aarti Gill, Co-Founder, OZiva, said. “Our focus has always been on providing innovative plant based nutritional supplements for holistic wellness. Women’s nutrition is an important focus area for us at OZiva. We have heavily invested in marrying customer requirements with R&D solutions to provide clean plant based nutrition.”   HerBones also comprises standardised herbal extracts like Lodh Bark, Ashoka, and Black Cohosh that help in balancing hormones like oestrogen to reduce the risk of osteoporosis in women. With zero added sugar and no artificial sweeteners, it also boasts of zero trans-fat and non GMO properties. Moreover, being soy free, gluten free and lactose free, makes it the perfect supplement for even those women with certain substance intolerances.  The product is priced at an attractive price range of Rs 899 and is available on www.oziva.in.   ]]> <![CDATA[PURIFY’20 – getting ready to showcase its next edition in Hyderabad]]> https://biospectrumindia.com/news/95/17416/purify20-getting-ready-to-showcase-its-next-edition-in-hyderabad.html https://biospectrumindia.com/news/95/17416/purify20-getting-ready-to-showcase-its-next-edition-in-hyderabad.html Tue, 20 Oct 2020 00:00:00 +0530 PURIFY’19 exceeded the industry expectations with some of the finest content that was shared with over 113 fellow chromatographers across 19 cities representing 51 companies. On the dais we had 14 industry experts addressing the gathering with their phenomenal experience in Chromatography Purification. With this successful edition, Custage Marketing Solutions LLP, Mumbai is now busy getting its act together to raise the bar still further with PURIFY’20. So here is this curtain raiser to the bigger and still better PURIFY’20!   PURIFY’20 is going to be on a much grander scale; block the date -  15th December, 2020 at ITC Kohenur, Hyderabad. The entire ballroom at  ITC Kohenur has been booked to ensure utmost comfort and space for the growing number of attendees expected as well as for our galaxy of speakers.   We have been doing our homework and have carefully crafted this edition to cover a myriad of topics with high-power quality sessions to empower you for the Chromatography Purification of tomorrow, including a breakout session dedicated to bio-molecules.   With the last edition, being the maiden one, touched upon a horizontal spectrum of content covering a lot of lateral topics, this edition is positioned to provide penetrative insight into the various relevant facets that are a part and parcel of every day routine of a day of a purification chromatographer! He will find answers to improve this productivity, know of newer technologies, better comprehend the market and regulatory requirements, get updated on the latest in technologies - current and forthcoming, get to know of the best global practices, with lots of practical tips on finally getting that additional gram of pure product at the lowest possible price!   With a never-before-experienced networking opportunity, a number of sponsors of PURIFY’19 quickly decided on their participation at PURIFY’20 and some even raised their sponsorship levels as well! What attendees appreciated the most was the networking opportunity with senior management who otherwise aren’t accessible easily. As the time of this print, the sponsor list for PURIFY’20 include renowned brands who have well empowered this industry to deliver - Nilsan Nishotech, Teledyne, YMC, Shimadzu, Buchi, Millennial Scientific, Chemito, Biotage and Daicel.   The event has attracted most leading media of this industry to participate.   Another first from PURIFY being its post-event coverage. The industry saw a very elaborate compilation of all that happened at PURIFY’19. The industry was in fact agog with the quality of content, quality of delegates, choice of speakers and their topics, expansive venue, luck draws etc.   Putting wind under the wings of PURIFY are also its esteemed advisory board members comprising of Katkam Srinivas, Vice President - Business Head,  Maithri, MSN Group of Companies, Hyderabad; S. Damodharan, Executive Vice President - Operational Excellence & New Technologies, Sai Life Sciences Ltd., Hyderabad; Somesh Sharma, Sr. Vice President - Discovery & Development Solutions, GVK Biosciences Pvt. Ltd., Hyderabad; Y. S. Lakshmi Narasimham, General Manager - Analytical, Novel Drug Discovery and Development, Lupin Ltd. (Research Park), Pune and Manish Chawla, Managing Partner, Custage Marketing Solutions LLP, Mumbai. They together bring an unparalleled experience to PURIFY’20 and create a knowledge platform that will provide significant business opportunities to stakeholders in chromatography purification.   One of the best ways to know all about PURIFY’19 and stay updated with the latest updates about PURIFY’20 is to follow the PURIFY LinkedIn page, a fast-growing virtual platform for all stakeholder in chromatography purification. PURIFY’20 is definitely going to be a mammoth of an event. We have strengthened our strengths and weakened our weaknesses to deliver to you the near-perfect event. ]]> <![CDATA[BDR Pharma launches Nintenib for treating idiopathic pulmonary fibrosis]]> https://biospectrumindia.com/news/95/17412/bdr-pharma-launches-nintenib-for-treating-idiopathic-pulmonary-fibrosis.html https://biospectrumindia.com/news/95/17412/bdr-pharma-launches-nintenib-for-treating-idiopathic-pulmonary-fibrosis.html Mon, 19 Oct 2020 17:45:00 +0530 BDR Pharmaceuticals, based in Mumbai, has announced the launch of 100mg and 150 mg Nindetanib under the brand name Nintenib for the treatment of idiopathic pulmonary fibrosis (IPF). Nintenib is priced at Rs 750 (100 mg) and Rs 900 (150 mg) for a pack of 10 tabs. Idiopathic pulmonary fibrosis (IPF) is a lung disorder where there is scarring of the lungs from an unknown cause. It is usually a progressive disease with a poor long-term prognosis. The median survival in IPF patients is 2.5 to 3.5 years. Nintedanib received DCGI approval after showing a significant slowdown in the disease progression in patients with pulmonary fibrosis by reducing the rate of decline in forced vital capacity (FVC) in patients with IPF and mild or moderate lung function impairment. Currently, there are two clinical trials being conducted to study the safety and efficacy of Nintedanib for the treatment of moderately to critically ill COVID-19 patients suffering from IPF. Dharmesh Shah, CMD, BDR Pharmaceuticals said, “We are thrilled to innovate and work towards introducing newer, effective and affordable treatment options for patients. We are proud to launch the generic version of the drug for lung fibrosis in India especially during a time when there is an ardent need of the medicine for COVID-19 patients. We are happy to lend our hand in any way to ensure the community is better prepared during this pandemic. With the launch of Nintedanib, we are on the verge of changing the therapeutic dynamics in the segment of tyrosine kinase inhibitors”. Nintedanib is a small molecule tyrosine kinase inhibitor, targeting vascular endothelial growth factor receptor (VEGFR), fibroblast growth factor receptor (FGFR) and platelet-derived growth factor receptor (PDGFR) involved in signalling pathways which lead to its use in pulmonary fibrosis. It has also shown significant efficacy in the management of non-small cell carcinoma of the lung as well as systemic sclerosis. ]]> <![CDATA[Dr Reddy’s receives approval to conduct clinical trial for Sputnik V vaccine]]> https://biospectrumindia.com/news/95/17403/dr-reddys-receives-approval-to-conduct-clinical-trial-for-sputnik-v-vaccine.html https://biospectrumindia.com/news/95/17403/dr-reddys-receives-approval-to-conduct-clinical-trial-for-sputnik-v-vaccine.html Mon, 19 Oct 2020 01:05:00 +0530 Dr Reddy’s Laboratories Ltd. and Russian Direct Investment Fund (RDIF), Russia’s sovereign wealth fund, have announced that they have received approval from the Drug Control General of India (DCGI) to conduct an adaptive phase 2/3 human clinical trial for Sputnik V vaccine in India. This will be a multi-center and randomized controlled study, which will include safety and immunogenicity study. Earlier in September 2020, Hyferabad based Dr. Reddy’s and RDIF entered into a partnership to conduct clinical trials of Sputnik V vaccine and its distribution in India. As part of the partnership, RDIF shall supply 100 million doses of the vaccine to Dr. Reddy’s upon regulatory approval in India. G V Prasad, Co-chairman and Managing Director, Dr. Reddy’s Laboratories, said “This is a significant development that allows us to commence the clinical trial in India and we are committed to bringing in a safe and efficacious vaccine to combat the pandemic.” Kirill Dmitriev, CEO of the Russian Direct Investment Fund, said, “We are pleased to collaborate with the Indian regulators and in addition to Indian clinical trial data, we will provide safety and immunogenicity study from the Russian phase 3 clinical trial. This data will further strengthen the clinical development of Sputnik V vaccine in India.” On August 11, 2020, the Sputnik V vaccine developed by the Gamaleya National Research Institute of Epidemiology and Microbiology was registered by the Ministry of Health of Russia and became the world’s first registered vaccine against COVID-19 based on the human adenoviral vectors platform. Sputnik V is currently undergoing phase 3 clinical trial in Russia and the proposed number of subjects is 40,000. Additionally, phase 3 clinical trial of the vaccine has commenced in the UAE last week. ]]> <![CDATA[Breast cancer awareness month: Niramai promotes breast health]]> https://biospectrumindia.com/news/95/17398/breast-cancer-awareness-month-niramai-promotes-breast-health.html https://biospectrumindia.com/news/95/17398/breast-cancer-awareness-month-niramai-promotes-breast-health.html Fri, 16 Oct 2020 17:40:00 +0530 October is Breast Cancer Awareness Month giving us a good opportunity to create more awareness amongst people about breast cancer and the importance of early detection. Every year around this month Bangalore based Niramai, an AI-based health tech company offers breast cancer awareness, initiates various screening camps, and offers a bunch of discounts to encourage women to take the first step towards breast health. They ensure as many people as possible hear and understand the breast awareness message whether that’s through social media or one of the women’s health webinars.   Niramai has special offers to empower women with knowledge about their health and wellbeing. Some of the initiatives by team Niramai 40% discount on all breast health services Sponsored second screening at a 50% discount  Online breast health assessment test - (Free until 15th October) This allows you to get a complete breast health check Through their services, Niramai aims to educate women about their breast health and urge others to support them in promoting breast cancer awareness.  ]]> <![CDATA[Life Essentials launches protection spray range to inactivate Covid-19 virus]]> https://biospectrumindia.com/news/95/17383/life-essentials-launches-protection-spray-range-to-inactivate-covid-19-virus.html https://biospectrumindia.com/news/95/17383/life-essentials-launches-protection-spray-range-to-inactivate-covid-19-virus.html Wed, 14 Oct 2020 11:55:00 +0530 Gurugram based Life Essentials Personal Care has launched a path-breaking and innovative range of No Alcohol - No Bleach Protection Sprays. Named ‘W2 Protection Spray Range’. The product has been scaled up, manufactured and commercialized by Life Essentials and is based on licensing of the ECORSANI technology developed by IIT Bombay. Ecorsani TM technology by IIT Bombay relates to biodegradable, safe, GRAS approved compositions. The Ecorsani formulation is antibacterial, antiviral and antifungal and on direct application has inactivated coronavirus samples. This technology when tested on SARS-nCOV2 (COVID 19) virus on the direct application has proven to inactivate the Covid 19 virus. The W2 Protection Spray Range includes - W2 Apparel Protection Spray, W2 Room Protection Spray, W2 Hand-Body Protection Spray and W2 Surface Protection Spray. The alcohol and bleach-free products have been formulated with a blend of all-natural, biodegradable, safe to use and made of GRAS (Generally recognized as safe) approved composition. The W2 Apparel Protection Spray when directly applied on clothes ensures protection from viruses, bacteria and fungi for up to 24 hours. The W2 Room Protection Sprays can be used for protecting one’s home or carrying it along so that it can be sprayed wherever one goes, be it an elevator, a cab, metro, office or a restaurant. The W2 Hand and Body Protection Spray can be applied to hands and any of the exposed body parts. The formulation of this product has been approved by the Ministry of AYUSH. The W2 Surface Protection Spray once applied on any hard surface like wood, tiles, metallic surfaces, can give protection for up to 24 hours. Amandeep Singh, Director, Life Essentials Personal Care said, “There is an urgent need for personal protection, for the public at large and especially the people who are going out of their houses every day. Our products are made to minimize the risk you and your loved ones face when they are going out or when someone is coming to your home or office".   ]]> <![CDATA[Epygen Biotech partners with Dyadic International for COVID-19 vaccine development]]> https://biospectrumindia.com/news/95/17381/epygen-biotech-partners-with-dyadic-international-for-covid-19-vaccine-development.html https://biospectrumindia.com/news/95/17381/epygen-biotech-partners-with-dyadic-international-for-covid-19-vaccine-development.html Wed, 14 Oct 2020 00:00:00 +0530 Mumbai based Epygen Biotech has recently entered into a non-exclusive technology usage agreement with US based Dyadic International, Inc. for COVID-19 vaccine development. Dyadic has developed a COVID-19 vaccine antigen from its proprietary and patented C1 cell line that can be produced at three grams per liter (3 g/l) in only five days. The proprietary C1 expressed receptor binding domain (RBD) of the SARS-CoV-2 spike protein is being used in animal trials by seven different research groups, governmental agencies and biopharma companies (including the Israel Institute for Biological Research (IIBR) and a collaboration of European Union scientists that participated with Dyadic in the ZAPI program). These parties are testing the C1 expressed RBD vaccine candidate(s) in animal trials on a stand-alone basis as well as testing the C1 RBD with nanoparticles and adjuvants. The company currently expects up to ten animal trials to be completed by the end of 2020. Epygen Biotech after obtaining required funding, is expected to produce cGMP clinical trial material at their facility and conduct clinical trials in India using Dyadic's C1 expressed RBD antigen of the SARS-CoV-2 Spike Protein. "The Epygen agreement demonstrates how potential collaborators globally can develop and eventually manufacture vaccines and drugs on a regional basis that are affordable, safe and effective. Debayan Ghosh, President and Founder of Epygen, is intimately familiar with our technology from his work at Biocon as a biotechnologist, his time spent working for Dyadic in the late 90's and, most recently, as a result of Epygen's interest in the manufacturing of cGMP clinical grade C1 expressed RBD antigens. It is especially gratifying for us to be working with someone who understands, firsthand, C1's success in industrial biotech and appreciates how the technology can be broadly applied to biopharmaceuticals," said Dyadic CEO, Mark Emalfarb. ]]> <![CDATA[Glenmark launches affordable pulmonary fibrosis drug in India]]> https://biospectrumindia.com/news/95/17385/glenmark-launches-affordable-pulmonary-fibrosis-drug-in-india.html https://biospectrumindia.com/news/95/17385/glenmark-launches-affordable-pulmonary-fibrosis-drug-in-india.html Wed, 14 Oct 2020 00:00:00 +0530 Glenmark Pharmaceuticals has launched NINDANIB (Nintedanib 100 and 150 mg capsules) for the treatment of pulmonary fibrosis in India. Glenmark being a leader in the area of respiratory has been amongst the first to launch the branded generic version at an affordable cost for the treatment of Pulmonary Fibrosis in India. This will provide patients a far more cost effective treatment option, and enable doctors to treat a wider patient population in the country. Nintedanib is approved by the Indian drug regulator for the treatment of Idiopathic (unknown cause) Pulmonary Fibrosis (IPF). Since IPF is a progressive disease that gets worse over time, starting treatment early and continuing treatment are important to slow disease progression. A lower monthly treatment cost therefore becomes crucial to ensure patients adhere to prescribed treatment in the long term. So far Nintedanib has been studied extensively in various controlled clinical trials that have established its efficacy and safety. In a recently published INBUILDtm trial, Nintedanib showed significantly lower annual rate of decline in FVC (Forced Vital Capacity) – a measure of lung health – with various progressive fibrosing interstitial lung diseases . Moreover, two clinical trials are being rolled out for to study the efficacy and safety of Nintedanib as a treatment of SARS-COV2 induced pulmonary fibrosis in Moderate to Severe COVID-19 patients. “With limited treatment options available, interstitial lung diseases pose a significant treatment challenge in India. The high price of newer treatments and the pill burden of existing options only add to poor patient adherence. By introducing NINDANIB, we hope to substantially reduce both the pill and cost burden for patients in India,” said Mr. Alok Malik, Group Vice President & Business Head, India Formulations. He added, “Glenmark continues to invent and innovate healthcare solutions that meet specific and often hard-to-address needs of patients in India and the world.” ]]> <![CDATA[NephroPlus acquires majority stake in RCDC in Philippines]]> https://biospectrumindia.com/news/95/17375/nephroplus-acquires-majority-stake-in-rcdc-in-philippines.html https://biospectrumindia.com/news/95/17375/nephroplus-acquires-majority-stake-in-rcdc-in-philippines.html Tue, 13 Oct 2020 13:35:00 +0530 NephroPlus has announced its first major overseas acquisition. Hyderabad based NephroPlus has acquired a majority stake in Royal Care Dialysis Centers, Inc (RCDC), a reputed dialysis network in the Philippines with a deep focus in delivering high-quality care. Through this strategic partnership, NephroPlus has become the 1st Indian dialysis network to expand overseas, marking the company’s transition to becoming a Multi-National Corporation (MNC). RCDC Network is a growing network in the Philippines and currently treats 400 dialysis patients across its 6 dialysis clinics located in Metro Manila and other nearby provinces. Through this deal, NephroPlus will be responsible for the network’s existing operations and will lend all its India based protocols, technologies and operational expertise to RCDC with an aim to improve dialysis care in the Philippines. As part of the company’s overseas expansion strategy, NephroPlus aims to expand the services in other provinces and grow this network to 50 dialysis centers in the next 5 years to be the dominant dialysis network in the Philippines by 2025. On closing the first overseas acquisition, Vikram Vuppala, Founder and CEO, NephroPlus said: “We are excited to add the team from RCDC to our network. Working together with this leadership team of RCDC, we are now aiming to become the largest dialysis network in the Philippines in the next 5 years. We have already started talking to several dialysis centers in the Philippines to fuel our expansion plans. With this entry into the Philippines, we reiterate our commitment to build a dominant multinational network across Asia, Middle East and CIS geographies.” ]]> <![CDATA[Cadila Pharma, ISCR put focus on pharmacoeconomics]]> https://biospectrumindia.com/news/95/17373/cadila-pharma-iscr-put-focus-on-pharmacoeconomics.html https://biospectrumindia.com/news/95/17373/cadila-pharma-iscr-put-focus-on-pharmacoeconomics.html Tue, 13 Oct 2020 00:00:00 +0530 Cadila Pharmaceuticals in association with Indian Society for Clinical Research (ISCR) is organizing a webinar on " Pharmacoeconomics in Drug development and medicine accessibility" for 2 hours starting 5.30 pm IST on 18th October, 2020 Dr V K Somani, DCGI has kindly agreed to be the Chief Guest for this Pharmacoeconomics and medicine accessibility webinar.  This webinar will feature National faculties and world renowned Pharmacoeconomics expert Professor Marcin Czech, former Deputy Minister of Health, Government of Poland. The objective of the webinar is to discuss the importance of Pharmacoeconomics in drug development and medication accessibility in developing countries like India.   Following is the agenda :   Welcome address by Chief Guest: Dr V K Somani, DCGI : 10 mins   Address by President/ Leadership team representative from Indian Society for Clinical Research (ISCR) about ISCR training activities in India : 10 mins   Introduction to Pharmacoeconmics : Dr Subhrojyoti Bhowmick , Clinical Director, Peerless Hospital, Kolkata: 20 mins   Role of Pharmacoeconomics in Innovative Drug development: Dr Bakulesh Khamar Director & Head of Research  &  Mr Amogh Dev Rai : Executive Director at Sanrachna  SGT University : 20 mins   Pharmacoeconomics as a tool to enable medicine accessibility: Prof Marcin Czech, Head of the dept of Pharmacoeconomics, Institute of Mother and child, Warsaw and ex-Deputy Minister of Health, Government of Poland : 30 mins   Question and Answers: 20 mins   According to Dr Subhrojyoti Bhowmick, Convener of this webinar “Pharmacoeconomic evaluation is an important tool during drug development and medication accessibility in developing countries like India and this webinar emphasizes on it. Insights from Prof Czech, who has been practicing implementation of pharmacoeconomic tools in drug pricing and accessibility in Poland will help us design similar strategies for our country.” “It is a very timely and insightful webinar. Expecting collaboration from more pharmaceutical companies and CROs to organize such webinars related to clinical research and drug development in near future”, said Snehendu Konar, one of the senior executive from organizing committee.   ]]> <![CDATA[Immuneel Therapeutics to offer affordable CAR Ts for patients in India]]> https://biospectrumindia.com/news/95/17377/immuneel-therapeutics-to-offer-affordable-car-ts-for-patients-in-india.html https://biospectrumindia.com/news/95/17377/immuneel-therapeutics-to-offer-affordable-car-ts-for-patients-in-india.html Tue, 13 Oct 2020 00:00:00 +0530 Immuneel Therapeutics, based in Bengaluru, has announced that it has entered into a multi-asset collaboration & licensing agreement with Hospital Clínic de Barcelona (HCB) & Institut d’Investigacions Biomèdiques August Pi i Sunyer (IDIBAPS). Under the collaboration which opens up opportunities for co-development of advanced assets to be deployed in Spain & India, Immuneel acquired the exclusive rights to develop & commercialise autologous ARI-0001 – a CD19 Chimeric antigen receptor (CAR) T cell therapy, in India. This agreement puts Immuneel as a front-runner in the pursuit of offering accessible & affordable CAR Ts to patients in India through registration clinical trials & its investments in further process optimization. Speaking about this milestone collaboration: Kiran Mazumdar Shaw (Co-founder, Immuneel) said, “This partnership with HCB & IDIBAPS is pathbreaking & heralds the advent of life saving CAR T therapy for patients in India. Immuneel is committed to providing affordable access to this cutting- edge therapy at state-of-the-art facilities housed at the Mazumdar Shaw Cancer Centre. I would particularly like to call out Dr. Campistol & Dr. Juan Uriach for their willingness to partner with us in our mission to give hope to cancer patients who can benefit from cell therapies.” HCB/IDIBAPS are public institutions that collaborated with a vision to create ARI-0001 as a product that can be an affordable option to treat patients with B cell malignancies in Spain. Dr. JM. Campistol (CEO, HCB) said, “We are extremely proud about this collaboration with Immuneel. We are convinced about the benefits of our CAR T therapy on patients with Acute lymphoblastic leukemia (ALL). This is the beginning of a fruitful & promising collaboration between  our  academic research  efforts (HCB   & IDIBAPS) & Immuneel to improve the treatment of hematological disorders.” Dr. Elias Campo (Research Director, HCB-IDIBAPS) added, “CAR T based therapies have shown efficacy in the treatment of certain leukemias & lymphomas. With this partnership we will improve our knowledge on this kind of therapies & more patients will benefit from them.” Dr. Siddhartha Mukherjee (Co-founder, Immuneel) further added, “Immuneel is extremely proud to bring this cutting-edge cell therapy to India. These "living drugs", created from genetically modified cells, have saved the lives of hundreds of cancer patients around the world but have been unavailable in India. Unlike standard medicines, these cell therapies have to be produced & delivered with immense car e & technical finesse. A clinically tested target like CD19 will enable Immuneel validate its clinical delivery for CAR T cells in India.” ]]> <![CDATA[UNIQLO introduces AIRism mask in India]]> https://biospectrumindia.com/news/95/17366/uniqlo-introduces-airism-mask-in-india.html https://biospectrumindia.com/news/95/17366/uniqlo-introduces-airism-mask-in-india.html Mon, 12 Oct 2020 02:10:00 +0530 Global apparel retailer UNIQLO, headquartered in Japan, has launched the AIRism Mask in India. Face masks are a simple and effective means of staying healthy in these challenging times. Today, face masks have become an essential item and UNIQLO catered to the customer requests and developed a mask that would optimize protection and comfort in daily use. The AIRism Mask reflects the UNIQLO commitment to making everyone's life better through LifeWear. The AIRism Mask employs a triple-layer structure that enhances the performance that is essential for such items. The center of the mask employs a filter that delivers a bacterial filtration efficiency of 99%, blocking droplets and protecting the skin from bacteria, virus-contaminated particles, and pollen. Sandwiching the filter is AIRism mesh fabric. In addition, the triple-layer structure has a UPF 40 rating, so it cuts 90% of ultraviolet rays. UNIQLO decided to launch its mask internationally following a release in Japan in June, which proved wildly popular from the first day it went on sale ]]> <![CDATA[Cadila Pharma offers new hope to cardiac patients]]> https://biospectrumindia.com/news/95/17363/cadila-pharma-offers-new-hope-to-cardiac-patients.html https://biospectrumindia.com/news/95/17363/cadila-pharma-offers-new-hope-to-cardiac-patients.html Fri, 09 Oct 2020 01:05:00 +0530 Cadila Pharmaceuticals launches Tikacad® in India, an antiplatelet drug-containing Ticagrelor, a P2Y12 platelet inhibitor indicated to reduce the rate of cardiovascular death, myocardial infarction, and stroke in patients with acute coronary syndrome (ACS) or a history of myocardial infarction (MI).  One in 4 deaths in India are because of CVDs where ischemic heart disease and stroke is responsible for >80% of this burden. Acute coronary syndrome (ACS) is a syndrome (set of signs and symptoms) due to decreased blood flow in the coronary arteries such that part of the heart muscle is unable to function properly or later results into fatality. To reduce this burden, Ahmedabad based Cadila Pharmaceuticals launched Tikacad® which has shown to reduce stroke incidence by 19% and ischemic stroke by 20%. For at least the first 12 months following ACS, it superior to has shown better results compared to Clopidogrel.“With the launch of Tikacad®, we want to give quality care and medications to heart patients. Tikacad® is the next in the long line of Cardiac specialty drugs produced by Cadila Pharmaceuticals such as Nodon and Teli AM. We are on a mission to keep serving the community” said Mr. Ravikiran Numburi, Vice-President, Sales and Marketing.“Tikacad® is a ray of hope for patients of Cardio-vascular diseases. With Tikacad® we aim to reduce the suffering of these patients and help them lead a long and happy life. We are committed to our promise of quality care and are constantly working towards finding the next innovative drug for our patients” said Mr. O.P. Singh, President -Sales and Marketing, Cadila Pharmaceuticals Limited.Tikacad is available in the form of 90mg tablets. Tikacad® containing Ticagrelor reduces the rate of stent thrombosis in patients who have been stented for treatment of ACS. Ticagrelor can also be used for the primary prevention of stroke in patients with coronary artery disease as approved by the USFDA. ]]> <![CDATA[BioSpectrum ranking special issue for Biopharma coming soon!]]> https://biospectrumindia.com/news/95/17208/biospectrum-ranking-special-issue-for-biopharma-coming-soon.html https://biospectrumindia.com/news/95/17208/biospectrum-ranking-special-issue-for-biopharma-coming-soon.html Fri, 09 Oct 2020 00:00:00 +0530 Amidst the pandemic, one more financial year concluded with lots of figures, calculations, positives and negatives, all related to finance and money, telling us where exactly the organisation stands today compared to the previous years. Everybody is interested in knowing the organisation’s performance – independent as well as compared to others in the sector. To highlight the achievements of the Biopharma based companies in India, BioSpectrum is planning the ranking special issue in December 2020. Companies will be ranked on the basis of their revenues and other achievements that took place in the last financial year FY19-20.   The last date for application is 20 October. Click below to fill the form- https://www.biospectrumindia.com/ranking-survey   ]]> <![CDATA[Philips India enhances access to care for sleep disorder patients]]> https://biospectrumindia.com/news/95/17357/philips-india-enhances-access-to-care-for-sleep-disorder-patients.html https://biospectrumindia.com/news/95/17357/philips-india-enhances-access-to-care-for-sleep-disorder-patients.html Thu, 08 Oct 2020 17:10:00 +0530 Royal Philips, a global leader in health technology has partnered with Indian Sleep Disorders Association (ISDA) to offer a first-of-its-kind six-month online certified course in Sleep Medicine.  Aligned with its focus on providing quality treatment for sleep disorders, Philips has trained more than 500 sleep technicians and guided the launch of more than 650 sleep labs in the country till date. The company also launched a dedicated sleep helpline and Home Sleep Test Solution to enhance access to care for patients suffering from sleep disorders. The six-month course on Sleep Medicine will focus on the management, diagnosis and treatment of sleep disorders. Qualified clinicians will be able to take up this course under the able guidance of Dr JC Suri, Director and Head, Department of Pulmonary, Critical Care and Sleep Medicine, Fortis Flt. Lt. Rajan Dhall Hospital, Vasant Kunj, New Delhi and Founder, President and Chairman, Indian Sleep Disorders Association. Philips has also launched a dedicated free sleep helpline for patients suffering from sleep apnea. Through this helpline, certified sleep educators will assist callers and help them understand their sleep patterns, educate them on the implications of poor sleep and guide them in seeking detailed diagnosis and treatment. This Home Sleep Testing Solution offered by Philips will support clinicians in doing a sleep test for potential sleep apnea patients in the comfort of their homes. The solution consists of a chest effort belt, a pulse oximeter and a single-use nasal cannula which capture vitals overnight. ]]> <![CDATA[Zydus brings India’s first pressurized metered dose inhaler]]> https://biospectrumindia.com/news/95/17358/zydus-brings-indias-first-pressurized-metered-dose-inhaler.html https://biospectrumindia.com/news/95/17358/zydus-brings-indias-first-pressurized-metered-dose-inhaler.html Thu, 08 Oct 2020 00:00:00 +0530 Zydus Cadila is launching Forglyn pMDI, India’s first pressurized Metered Dose Inhaler (pMDI) with a combination of Long Acting Muscarinic Antagonist (LAMA) and Long Acting Beta Agonist (LABA) for patients suffering from Chronic Obstructive Pulmonary Disease (COPD) in India. Forglyn pMDI is priced at Rs. 495 per pack and has been developed in-house using Zydus’ innovations in formulation technology. The administration of the two drugs Formoterol fumarate (LABA) + Glycopyrrolate (LAMA) in a single inhalation will improve outcomes due to the desired synergistic effect of the two drugs and a better adherence to the treatment. Speaking on the development, Managing Director, Cadila Healthcare Ltd., Dr. Sharvil Patel said, “Our focus has always been on helping people lead a better quality of life and making therapies accessible and affordable to people. Our innovations have brought in next-generation therapies in respiratory, women’s healthcare, cardio-metabolic disorders, gastrointestinal and pain management segments. With this new technology, we hope to bring much relief to patients suffering from COPD and help them improve their health and quality of life.” The novel process for Forglyn pMDI developed at the group’s Pharmaceutical Technology Center, ensures that delivery of the two drugs administered simultaneously through the inhaler are consistent and uniform which is critical for inhalation products. The process technology employed for the manufacturing of this product is simple, affordable and scalable. The Company has also filed a patent application for the novel process of this product. ]]> <![CDATA[USFDA approves Lupin’s Dimethyl Fumarate Delayed-Release Capsules]]> https://biospectrumindia.com/news/95/17343/usfda-approves-lupins-dimethyl-fumarate-delayed-release-capsules.html https://biospectrumindia.com/news/95/17343/usfda-approves-lupins-dimethyl-fumarate-delayed-release-capsules.html Wed, 07 Oct 2020 10:55:00 +0530 Pharma major Lupin Limited (Lupin) announced that it has received approval for its Dimethyl Fumarate Delayed-Release Capsules, 120 mg and 240 mg, from the United States Food and Drug Administration (US FDA), to market a generic equivalent of Tecfidera® Delayed-Release Capsules, 120 mg and 240 mg, of Biogen,  Inc. The product is expected to be launched shortly. Dimethyl Fumarate Delayed-Release Capsules, 120 mg and 240 mg, are indicated for the treatment of patients with relapsing forms of multiple sclerosis, to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, in adults. Dimethyl Fumarate Delayed-Release Capsules (RLD: Tecfidera®) had an annual sales of approximately $3788 million in the US (IQVIA MAT June 2020). ]]> <![CDATA[Alliance inks marketing agreement with Alniche Life Sciences]]> https://biospectrumindia.com/news/95/17342/alliance-inks-marketing-agreement-with-alniche-life-sciences.html https://biospectrumindia.com/news/95/17342/alliance-inks-marketing-agreement-with-alniche-life-sciences.html Wed, 07 Oct 2020 00:00:00 +0530 The healthcare group, Alliance, based in the UK is pleased to announce that it has appointed Alniche as its exclusive marketing partner in India to market and distribute the Nizral/Nizoral range of formulations. Transfer of the business was successfully concluded during September.  To demonstrate its commitment to the Indian market, Alliance CHC (India) Private Limited was incorporated during August 2020, with its office located in the bustling city of Mumbai. Rajiv Ghildiyal, Alliance's Regional Business Director – Central Asia, Middle-East & Pacific commented, "With the acquisition of a great brand comes great responsibility, as we look to take over and maintain the long-standing quality, heritage and brand awareness built by our J&J colleagues over the past decades. Together with the marketing and distribution excellence of our local partner Alniche Life Sciences, we aim to consolidate and expand this awareness and reach beyond Metro's and Class A towns so that more of the Indian population can benefit from this time-tested remedy for scalp and related skin conditions." Girish Arora, Founder and Managing Director of Alniche Lifesciences expressed, "Nizral is a welcome addition in our product portfolio. With Nizral's excellent brand equity and seal of quality Alniche is confident to build this brand to attain leader position in Anti-dandruff market." Alliance acquired J&J's Nizoral range of shampoos in 2018 for the Asia Pacific region. In 2018, Alliance further strengthened its consumer healthcare portfolio with the acquisition of medicated antidandruff shampoo and lotion (lotion currently only available in Japan), Nizoral, from Janssen Pharmaceutica NV (a member of the Johnson & Johnson group) for the APAC (Asia Pacific) region. This acquisition significantly increased Alliance's presence in the 15 countries where Nizoral is currently registered. In India, Nizoral is registered as Nizral 2% and Nizoral 1%, both part of this acquisition. Nizoral's API, ketoconazole (antifungal) was discovered by Janssen in 1976. With more than 50 clinical studies carried out, it is one of the most widely prescribed anti-fungal medicine in the world, treating seborrheic capitis (dandruff), seborrheic dermatitis, pityriasis versicolor.   Image caption- Sitting (R-L): Mr. Alex Duggan - Chief Commercial Officer, Alliance Pharmaceuticals Limited, Mr. Girish Arora - Founder & MD, Alniche Life Sciences, Mr. Rajiv Ghildiyal - Regional Business Director, Central Asia Middle East and Pacific, Alliance Pharmaceuticals Limited, Ms. Ritu Hasija - Director Corporate Affairs, Alniche Life Sciences, Standing: Alniche Life Sciences Leadership Team ]]> <![CDATA[Medulance, MyGate to provide medical emergency transportation services ]]> https://biospectrumindia.com/news/95/17334/medulance-mygate-to-provide-medical-emergency-transportation-services-.html https://biospectrumindia.com/news/95/17334/medulance-mygate-to-provide-medical-emergency-transportation-services-.html Tue, 06 Oct 2020 12:55:00 +0530 Delhi-based Medulance Healthcare, a comprehensive end-to-end emergency response service provider has recently announced its partnership with MyGate, a security and community management app. The partnership will empower millions of MyGate users in 8 major cities with easy access to medical emergency transportation. The initiative will connect over 14 lakhs residential flats in Delhi-NCR, Pune, Mumbai, Chennai, Kolkata, Ahmedabad, Chandigarh, and Lucknow via a single emergency helpline number powered by Medulance. Amidst the pandemic, Medulance launched Medualert, a solution to cater to the emergency needs of residents of a society or employees of the organizations and their family members via a dedicated helpline number. MyGate users can avail of Medulance services via a dedicated Medualert Emergency Helpline Number set up exclusively for them. Leveraging the proprietary emergency management technology, Medualert assures 100% call answer, first-aid in the call within 30-45 seconds of a call being made, dispatching the ambulance within 3 minutes of the call, and providing a total response time of under 25 minutes. Founded in 2017, Medulance Healthcare is India’s first & leading comprehensive emergency response service provider, extensively dealing in ambulatory services, emergency management technology, activation of in-house medical rooms, specialized first-aid, and safety training. ]]> <![CDATA[LANXESS India receives multiple awards from Indian Chemical Council]]> https://biospectrumindia.com/news/95/17333/lanxess-india-receives-multiple-awards-from-indian-chemical-council.html https://biospectrumindia.com/news/95/17333/lanxess-india-receives-multiple-awards-from-indian-chemical-council.html Tue, 06 Oct 2020 11:55:00 +0530 LANXESS India was honoured with multiple awards by the the Indian Chemical Council (ICC) recently. The ICC Awards function was held virtually on September 25, in the presence of Chief Guest Rajesh Kumar Chaturvedi, IAS, Secretary, Department of Chemicals & Petrochemicals, Government of India and Purnendu Chatterjee, Founder & Chairman, Haldia Petrochemicals & The Chatterjee Group. LANXESS India, based in Thane, was recognised for its commitment and outstanding performance specifically in the areas of Environment and Human Resource Management under the ‘Large Companies’ category. It also won the Certificate of Merit for Best Compliant Company for two codes under Responsible Care - Process Safety Code & Distribution Code. Additionally, based on the Nicer Globe Initiative of ICC for Transportation Safety, two of the top three drivers who were engaged by LANXESS were awarded as the ‘Best Drivers’ for their disciplined performance towards road safety. The Responsible Care Award by ICC recognised the organisation’s ongoing efforts in maintaining high Process Safety and Distribution standards through effective site management. Commenting on the success, Neelanjan Banerjee, Vice Chairman and Managing Director, LANXESS India who was recently appointed the Vice Chair of the National Chemicals & Petrochemicals Committee of CII (Confederation of Indian Industry) for 2020 – 21 and also Head of the sub-committee on Safety and Sustainability at CII, said, “This is an extremely proud moment for us as we have been continually striving to set newer benchmarks in the areas of business processes and efficiencies with special focus on environmental topics and safety. We are privileged and honoured that our efforts in these areas have been acknowledged by ICC.” Wins following awards for the year 2019:  ·         Best Company  for Management of Environment ·         Best Company for Human Resource Management ·         Certificate of Merit for Best Compliant Company under Responsible Care - Process  Safety Code & Distribution Code ·         Under the Nicer Globe Initiative of ICC, two drivers contracted by LANXESS awarded as 'Best Drivers' ]]> <![CDATA[Medicure inks agreement with Reliance LS for marketing cardiovascular biosimilar]]> https://biospectrumindia.com/news/95/17340/medicure-inks-agreement-with-reliance-ls-for-marketing-cardiovascular-biosimilar.html https://biospectrumindia.com/news/95/17340/medicure-inks-agreement-with-reliance-ls-for-marketing-cardiovascular-biosimilar.html Tue, 06 Oct 2020 00:00:00 +0530 Medicure Inc., a pharmaceutical company based in the US, has announced that through its wholly-owned subsidiary, Medicure International Inc., it has entered into a License, Manufacture and Supply Agreement with Reliance Life Sciences for a cardiovascular biosimilar. Medicure is responsible for the regulatory approval process for the product. A biosimilar is a biological product that is highly similar to and has no clinically meaningful differences from an approved reference product. The Agreement grants an exclusive right to Medicure to market and sell the Product in the United States of America, Canada and the European Union. "We are very pleased with the agreement we have reached with RLS. The Product fits well with Medicure's mission of being a significant cardiovascular company focused on the U.S. market." commented Dr. Albert Friesen, Chief Executive Officer for Medicure. "We look forward to the growth of our portfolio of cardiovascular products." ]]> <![CDATA[Dr Reddy’s sets science based targets to minimize environmental impact]]> https://biospectrumindia.com/news/95/17329/dr-reddys-sets-science-based-targets-to-minimize-environmental-impact.html https://biospectrumindia.com/news/95/17329/dr-reddys-sets-science-based-targets-to-minimize-environmental-impact.html Mon, 05 Oct 2020 17:05:00 +0530 Hyderabad based Dr Reddy’s Laboratories Ltd. has recently joined the Science Based Targets initiative’s (SBTi) business ambition for 1.5°C, becoming the first Indian and the third Asian pharmaceutical company to have set its Science-Based Targets to further minimize environmental impact.  The Company has committed to reducing its Scope 1 and 2 greenhouse gas (GHG) emissions by 55 percent by 2030 from a FY2017-18 base year, which are in line with the latest climate science of limiting global warming to below 1.5°C above pre-industrial levels. As of FY 2019-20, Dr Reddy’s has reduced its Scope 1 emissions by 8.6% and Scope 2 emissions by 20.7 per cent over the baseline of FY 2017-18. The combined Scope 1 and 2 emissions have been reduced by 13% over the same base year, putting it on a fast track to achieving GHG reduction targets. Science-Based Targets initiative (SBTi), a joint initiative of Carbon Disclosure Project (CDP), United Nations Global Compact (UNGC), World Resources Institutes (WRI) and World Wide Fund (WWF), provides companies with a clearly defined pathway to future-proof growth by specifying how much and how quickly they need to reduce their greenhouse gas emissions to limit global warming to well-below 2°C above pre-industrial levels. 472 companies have already set their targets as per SBTi. In the Pharmaceutical & Biotech sector globally, 17 companies have successfully set their emission reduction targets affirming their pledge to mitigate climate change impacts. ]]> <![CDATA[Centaur launches novel drug for treating diabetic foot ulcer]]> https://biospectrumindia.com/news/95/17328/centaur-launches-novel-drug-for-treating-diabetic-foot-ulcer.html https://biospectrumindia.com/news/95/17328/centaur-launches-novel-drug-for-treating-diabetic-foot-ulcer.html Mon, 05 Oct 2020 16:55:00 +0530 Mumbai based Centaur Pharmaceuticals has recently announced the launch of a New Chemical Entity (NCE)- WOXheal®, for the first time in the world. With its dual mechanism of action, WOXheal® is a unique product in the treatment of diabetic foot ulcers, and it will save millions of diabetics who have to undergo foot amputation globally. Diabetic foot ulcer is the most common complication seen in India. Data indicates that 25% of people with Diabetes, will develop a Diabetic Foot Ulcer in their lifetime. 1 in 5 Diabetics who are hospitalized due to severe foot infection, undergo a foot amputation affecting the livelihood of the family. A globally patented product, WOXheal® topical solution, is effective in treating Diabetic foot ulcers. WOXheal® contains the NCE, Diperoxochloric acid, also called as DPOCL. WOXheal® has dual mechanism of action, i.e. it has functional antibacterial action against Gram-positive and Gram-negative bacteria and it also promotes the growth of fibroblast cells, thereby yielding complete wound closure. Randomized clinical trials conducted across India in over 15 clinical trial centres on WOXheal® elucidated that over 90 per cent of patients with non-healing diabetic foot ulcer showed a reduction in the size of the ulcer, and 75% out of these patients achieved complete healing within 6-8 weeks without any safety issue. The data and outcomes of the trial were submitted to the Indian Regulatory Authority and a manufacturing and marketing approval was granted to Centaur Pharmaceuticals for WOXheal®.   ]]> <![CDATA[SHARP-QNET offers air purifiers to deactivate coronavirus by 90%]]> https://biospectrumindia.com/news/95/17327/sharp-qnet-offers-air-purifiers-to-deactivate-coronavirus-by-90.html https://biospectrumindia.com/news/95/17327/sharp-qnet-offers-air-purifiers-to-deactivate-coronavirus-by-90.html Mon, 05 Oct 2020 16:50:00 +0530 QNET has recently offered SHARP-QNET ZENsational air purifier and Plasmacluster ion products with Sharp’s patented Plasmacluster® ion technology (PCI) in the device to help deactivate airborne novel coronavirus (SARS-CoV-2) when exposed to the technology for approximately 30 seconds by 90%. The PCI Technology has been certified by over 30 global Institutes, including IIT Delhi. The study on the efficacy of PCI technology in deactivating coronavirus was undertaken by Japanese professors of Nagasaki and Shimane University. SHARP-QNet ZENsational Air Purifier has Sharp’s patented Plasmacluster® ion technology, an integrated humidifier, and 7 Intelligent-Detection Modes, the first of its kind in this category. The co-branded air purifier is the second product partnership between QNET and SHARP. The product models - SHARP-QNET Plasmacluster® Ion Air Purifier and ZENsational Air purifier are QNET’s top-selling products in recent years in India. The ZENsational Air purifier has an intelligent sensor system that monitors and indicates the dust, odour, haze, temperature, and humidity conditions of the room. Based on the requirement, the sensors detect the need and automatically adjust the function, resulting in energy efficiency. This path-breaking achievement was accomplished in collaboration with internationally respected authorities on infectious diseases and research, through - National Research Center for the Control and Prevention of Infectious Diseases/Institute of Tropical Medicine, Nagasaki University, Japanese Society for Virology, Department of Microbiology, and Shimane University. Sharp has been demonstrating the effectiveness of Plasmacluster technology by working in collaboration with independent third-party research organizations around the world. ]]> <![CDATA[Zydus Healthcare launches Dapagliflozin tablets for T2D treatment]]> https://biospectrumindia.com/news/95/17322/zydus-healthcare-launches-dapagliflozin-tablets-for-t2d-treatment.html https://biospectrumindia.com/news/95/17322/zydus-healthcare-launches-dapagliflozin-tablets-for-t2d-treatment.html Mon, 05 Oct 2020 00:00:00 +0530 Zydus  Healthcare  Limited, headquartered in Ahmedabad, announced that it is launching the  anti-diabetic Dapagliflozin tablets in India upon its patent expiry under the brand name ‘Dapaglyn’. In keeping with its efforts to make therapies accessible and affordable to patients, the drug will be highly economical, priced at 1/3rd the cost than currently available Dapagliflozin brands in India. A once-daily oral treatment indicated as an adjunct to diet and exercise, Dapaglyn aims to improve glycemic control in adults with Type 2 diabetes mellitus. Dapagliflozin is part of a newer class of medications called sodium-glucose co-transporter 2 (SGLT2) inhibitors. It lowers blood sugar by causing the kidneys to get rid of more glucose in the urine. People who have diabetes can develop serious or life-threatening complications, including heart disease, stroke, kidney problems, nerve damage, and eye problems. Taking Dapagliflozin, alongwith lifestyle changes (e.g., diet, exercise, quitting smoking), and regularly checking one’s blood sugar may help patients manage their blood sugar levels and improve their health. With Dapaglyn, a new generation of anti-diabetic therapy will now be accessible to a larger number of patients, thereby bringing in better compliance and improved disease management. ]]> <![CDATA[GangaGen Biotech receives funds to tackle drug resistant pneumonia bacteria]]> https://biospectrumindia.com/news/95/17325/gangagen-biotech-receives-funds-to-tackle-drug-resistant-pneumonia-bacteria.html https://biospectrumindia.com/news/95/17325/gangagen-biotech-receives-funds-to-tackle-drug-resistant-pneumonia-bacteria.html Mon, 05 Oct 2020 00:00:00 +0530 Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator (CARB-X), based in the US, is awarding up to US$2.5 million to GangaGen Biotechnologies, headquartered in Bangalore, India, to develop novel antibacterial proteins, called klebicins, to treat pneumonia caused by Klebsiella pneumoniae, a difficult-to-treat bacteria belonging to the Enterobacterales family of Gram-negative pathogens. GangaGen will be eligible for an additional $8.1 million in funding from CARB-X if project milestones are met, subject to available funds. “GangaGen is researching a highly innovative approach to treat infections caused by multidrug-resistant K. pneumoniae, including the carbapenem-resistant and Extended-Spectrum β-Lactamase (ESBL)-expressing strains of particular clinical concern,” said Erin Duffy, R&D Chief of CARB-X, a global partnership led by Boston University dedicated to supporting the development of antibacterial products to diagnose, prevent and treat drug-resistant infections. “The project is in the early stages of development and if successful, it could represent progress in the treatment of multidrug-resistant bacterial infections.” Tanjore S Balganesh, President of GangaGen Biotechnologies, said: “We are delighted to receive CARB-X’s support to progress the klebicin programme. K. pneumoniae is a hard-to-treat pulmonary pathogen resistant to many of the current antibiotics. Additionally, hypervirulent strains of the pathogen are being isolated in many parts of the globe.” GangaGen is developing klebicins, which are naturally occurring protein antibiotics, as precision agents to target K. pneumoniae. Klebicins’ novel mechanism of action enables specific killing of the target pathogen without impacting the microbiome. Klebicins have shown potent activity against K. pneumoniae in in vivo studies. The CARB-X award will support further discovery, protein engineering and development of potent klebicins for the treatment of hospital-acquired pneumonia (HAP) and ventilator-associated pneumonia (VAP) caused by K. pneumoniae. Vivek Daniel Paul, GangaGen’s Principal Investigator said: “The klebicin molecules have a novel mode of action and represent a unique opportunity to discover, design and develop novel antibacterials. We look forward to progressing these molecules.” ]]> <![CDATA[Bharat Biotech partners with ViroVax for boosting immune response of Covaxin]]> https://biospectrumindia.com/news/95/17326/bharat-biotech-partners-with-virovax-for-boosting-immune-response-of-covaxin.html https://biospectrumindia.com/news/95/17326/bharat-biotech-partners-with-virovax-for-boosting-immune-response-of-covaxin.html Mon, 05 Oct 2020 00:00:00 +0530 Bharat Biotech has announced its novel Coronavirus vaccine COVAXIN® approved for human trials, will use adjuvant Alhydroxiquim-II to boost immune response and longer lasting immunity. The technology is being used under this licensing agreement with Kansas-based ViroVax LLC. COVAXIN® is an inactivated vaccine derived from a strain of SARS-CoV-2 virus, isolated at the National Institute of Virology (NIV), Pune, an Indian virology research institute. The inactivated virus is formulated with ViroVax’s adjuvant to produce the vaccine candidate. Hyderabad based Bharat Biotech is currently conducting Phase II human trials of COVAXIN after receiving approval from the Drug Controller General of India (DCGI). Dr. Krishna Ella, Chairman and Managing Director of Bharat Biotech, said, “There is critical need for development and availability of adjuvants that elucidate mechanisms of action inducing greater antibody responses to vaccine antigens, thus resulting in long-term protection against pathogens. Adjuvants also enhance the sustainability of the global vaccine supply on account of their antigen-sparing effect. Our partnership with ViroVax resonates with Bharat Biotech’s relentless efforts towards developing safe and effective vaccines coupled with long term immunity.” Dr. Ella further added, “The widely used adjuvant Aluminium hydroxide in the development of SARS CoV-2 vaccines is known to induce a Th2 based response (which are important for eradication of extracellular parasites and bacterial infection). The Th2 based response has a theoretical risk of vaccine associated enhanced respiratory diseases (VAERD or ADE). We have used Imidazoquinoline class of adjuvants (TLR7/8 agonists), which are known to induce Th1 based response which further reduces the risk of ADE (Anti-Body Dependent Enhancement). In the preclinical studies and animal challenge models (Syrian Hamster and Rhesus Macaques) we have shown that COVAXIN® induced Th1 based response due to the use of Algel-IMDG (chemosorbed imidazoquinoline onto the aluminum hydroxide gel) as an adjuvant." “ViroVax is delighted to partner with Bharat Biotech. This has been possible because of support from the National Institutes of Health,” said Dr. Sunil David of ViroVax.  In response to the COVID-19 pandemic, ViroVax also received supplemental funding for the development of subunit vaccine constructs for the prevention of COVID-19, and for the discovery and development of therapeutics for treating COVID-19. ViroVax is evaluating a subunit vaccine candidate and has identified potential antiviral therapeutics. It is currently in the process of testing the efficacy of these compounds. ViroVax is supported by contract HHSN272201800049C from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. ]]> <![CDATA[Sirona launches first period kit for menstruation management ]]> https://biospectrumindia.com/news/95/17310/sirona-launches-first-period-kit-for-menstruation-management-.html https://biospectrumindia.com/news/95/17310/sirona-launches-first-period-kit-for-menstruation-management-.html Thu, 01 Oct 2020 12:20:00 +0530 New Delhi based Team Sirona, the maker of PeeBuddy, has recently launched the first period kit for this Daughter’s Day. It is India’s first comprehensive period kit that has all a young girl needs to understand and manage periods in a healthy, unapologetic manner.  The kit has the Sirona First Period Booklet, designed especially for her to keep her informed about the changes in her body and the onset of periods. It has Sirona’s Flow Catchers box that holds an assortment of rash-free and biodegradable coloured pads, tampons and panty liners. For her period cramps, Sirona has added a pack of 100% herbal hydrogel-based pain relief patches that she can use on the go! The kit has a period calendar that helps her keep track of her period cycles. Then there is India’s 1st 100% herbal anti-chafing rash cream by Sirona that safely heals inner thigh rashes. To help her stay on top of hygiene, it has Sirona’s intimate wipes and intimate wash. It doesn’t end here; Sirona has added its oxo-biodegradable disposal bags to offer her a hassle-free and discreet way of sanitary waste disposal.  Sirona stands for solving unaddressed intimate and menstrual hygiene issues with our unique category-defining products. Keeping the legacy going, we have taken on yet another issue - lack of a comprehensive solution for young girls as they step into menstruation. Sirona First Period Kit aims to break these perceptions, by answering unaddressed questions and associating strength with periods.   ]]> <![CDATA[Jehan Impex introduces first swab flocking machine in India]]> https://biospectrumindia.com/news/95/17309/jehan-impex-introduces-first-swab-flocking-machine-in-india.html https://biospectrumindia.com/news/95/17309/jehan-impex-introduces-first-swab-flocking-machine-in-india.html Thu, 01 Oct 2020 11:55:00 +0530 Mumbai based Jehan Impex that stands at the forefront as a pioneer in India for manufacturing high voltage generators, ART-O-FLOCK™ electrostatic flocking machines, flocking assemblies, corona surface treaters and in-mould foil chargers, has recently taken a step ahead to become the pioneer in the manufacturing of the Swab Flocking machine in India. Jehan Impex started the development and innovation of existing flocking machines in March 2020 with the sole motive of manufacturing a machine that can help to produce flocked swabs in India at a cheaper rate and better quality in comparison with the international market. The approximate cost of Jehan Impex machinery is 2-5 Lakhs per unit depending on the model & customization whereas the cost of imported machinery 8-12 lakhs. An estimate of 400 swabs are flocked in 20 seconds for conducting mass tests in India. Flock swab marks an innovation in medical swab technology and features perpendicular Nylon Fibres that provide optimum collection and release of the specimen samples. The flocked technology turns each strand of fiber into a velvet brush-like texture and creates hundreds of contact points for superior collection and release of solid and semi-solid specimen samples.  Jehan Impex has been providing its machinery and raw materials to key pharmaceutical companies such as HiMedia Laboratories Pvt. Ltd., Micromaster Laboratories Pvt. Ltd., Suparshva Swab (I), CML Biotech Pvt. Ltd., Bhat Biotech Pvt. Ltd., Levram Lifesciences Pvt. Ltd, etc. ]]> <![CDATA[ABEC supports Serum Institute for large scale COVID-19 vaccine manufacturing]]> https://biospectrumindia.com/news/95/17306/abec-supports-serum-institute-for-large-scale-covid-19-vaccine-manufacturing.html https://biospectrumindia.com/news/95/17306/abec-supports-serum-institute-for-large-scale-covid-19-vaccine-manufacturing.html Thu, 01 Oct 2020 00:00:00 +0530 ABEC, a leading global provider of integrated solutions and services for biopharmaceutical manufacturing based in the US, has announced it is supporting Serum Institute of India Pvt. Ltd. (SIIPL) in Pune by delivering six 4,000L CSR bioreactors for the manufacturing of Novavax’ COVID-19 vaccine candidate, NVX‑CoV2373. Serum Institute, the world’s largest vaccine manufacturer by number of doses, will utilize ABEC’s single-use technologies to advance a global supply of NVX‑CoV2373 throughout India and low- and middle-income countries. Serum Institute’s new facility will be the largest single-use bioreactor-based vaccine manufacturing line in the world. ABEC’s 4,000L CSR single-use bioreactors are the largest in the industry by a factor of two, allowing Serum Institute to double productivity per unit floorspace and achieve the lowest possible cost per dose. Leveraging its global presence, ABEC is manufacturing the single-use bioreactors and disposable containers (DC) in its US and Ireland facilities to meet Serum Institute’s accelerated schedule. ABEC’s multi-site global ISO-7 cleanrooms ensure a robust supply chain with the industry’s shortest DC lead times, enabling Serum Institute to begin production in early 2021. ]]> <![CDATA[Syngene conducts proactive COVID-19 testing for all employees]]> https://biospectrumindia.com/news/95/17299/syngene-conducts-proactive-covid-19-testing-for-all-employees.html https://biospectrumindia.com/news/95/17299/syngene-conducts-proactive-covid-19-testing-for-all-employees.html Wed, 30 Sep 2020 15:30:00 +0530 Bengaluru-based Syngene, an integrated research, development and manufacturing services company, has taken the lead in proactively conducting free COVID-19 tests for its 5000 employees in Karnataka. As the number of new cases worldwide continues to escalate, the case for increasing the level of testing strengthens and these tests will ensure the highest safety standards for employees. The free COVID-19 tests are being conducted at the Syngene testing facility in Bangalore that was set-up in April 2020, in order to support the government initiative to increase testing. The main objectives of increased testing are to facilitate faster access to medical care; rapid testing and quarantining of primary contacts; greater protection for vulnerable populations; and, as a result, achieving a reduction in infection transmission. Increased testing has the additional benefit of reducing anxiety for individuals by providing greater certainty about their infection status. Syngene is working with more than 50 employers in and around Bangalore including Cipla, Tata Aerospace and Defence, a representative body of 200-member organizations in the Electronic City area to offer COVID-19 testing to their employees. With many months of experience, the company offers advice on supporting employees, practical COVID measures on site, evidence-based workforce planning and business continuity planning. With the broad range of scientific expertise in relevant disciplines available at Syngene, the company is also working to supply reagents, primers and probes for COVID-19 diagnostic testing to clients. Syngene is also working on research projects related to vaccine development which could represent a longer-term solution for fighting the coronavirus pandemic. ]]> <![CDATA[Sanofi Pasteur India launches booster vaccine for preschoolers]]> https://biospectrumindia.com/news/95/17304/sanofi-pasteur-india-launches-booster-vaccine-for-preschoolers.html https://biospectrumindia.com/news/95/17304/sanofi-pasteur-india-launches-booster-vaccine-for-preschoolers.html Wed, 30 Sep 2020 00:00:00 +0530 Sanofi Pasteur India, the vaccines global business unit of Sanofi announced the launch of Tetraxim® (DTaP-IPV). The booster vaccine is indicated for preschoolers and provides protection against four major diseases - Diphtheria, Pertussis, Tetanus and Polio. Tetraxim® combines four vaccines into one, thus reducing the number of injections, increasing comfort and improving vaccination compliance for children and reducing parental anxiety. As immunity against Diphtheria, Tetanus, and Pertussis wanes over time, it is important to ensure necessary protection by being up to date with booster vaccinations. A vaccine containing full-dose antigens stimulates adequate immune response with better tolerability. This ensures preschoolers receive the right vaccine with the appropriate antigen content at the right time and have sustained protection against disease. With Tetraxim®, Sanofi Pasteur currently protects school children in more than 100 countries, with 63 million doses distributed worldwide. Annapurna Das, COUNTRY HEAD, INDIA, Sanofi Pasteur said, “Booster vaccines are designed to boost the immunity acquired during prior vaccination. It works as a reminder for a child’s immune system and can also stop the spread of infection to their siblings and grandparents, making it important to maintain vaccination schedules of preschoolers.” The Indian Academy of Pediatrics, an association of Indian pediatricians, recommends full-dose DTaP for preschoolers.  ]]> <![CDATA[Serum Institute to produce additional 100M doses of COVID-19 vaccine]]> https://biospectrumindia.com/news/95/17294/serum-institute-to-produce-additional-100m-doses-of-covid-19-vaccine.html https://biospectrumindia.com/news/95/17294/serum-institute-to-produce-additional-100m-doses-of-covid-19-vaccine.html Tue, 29 Sep 2020 03:15:00 +0530 A further collaboration among the Serum Institute of India (SII), the world’s largest vaccine manufacturer by volume, Gavi and the Bill & Melinda Gates Foundation will accelerate the manufacture and delivery of up to 100 million doses of safe and effective COVID-19 vaccines for India and low-and middle-income countries (LMICs) as part of the Gavi COVAX AMC, a mechanism within the COVAX Facility. This brings the total number of vaccine doses to be covered by the partnership between SII, Gavi, and the Gates Foundation to an aggregate of up to 200 million doses, following the initial agreement for up to 100 million doses announced in August.The arrangement again provides an option to secure additional doses if the vaccines pillar of the Access to COVID-19 Tools (ACT) Accelerator sees a need for it. The collaboration will provide upfront capital to SII to help it increase manufacturing capacity now so that, once a vaccine, or vaccines, gains regulatory approval and WHO Prequalification, doses can be distributed at scale to LMICs as part of the Gavi COVAX AMC mechanism as early as the first half of 2021. “The collaboration further bolsters up our fight against COVID-19! Through the avid support of Gavi and the Bill & Melinda Gates Foundation, we will now manufacture and deliver up to an additional 100 million doses of immunogenic and safe-proven future COVID-19 vaccines to India andlow-and middle-income countries in 2021,” said Adar Poonawalla, CEO of Serum Institute of India “At this stage, It is important for governments, global health and financial institutions in the public and private sector to come together in ensuring that no one is left behind in the road to recovery. This association is In line with our efforts to see that the future vaccines reaches the remotest part of the world providing full immunization coverage in a bid to contain the spread ofthe pandemic.” The funding will help accelerate the manufacturing by SII for candidate vaccines licensed from AstraZeneca and Novavax, which will be available for procurement if they are successful in attaining full licensure and WHO Prequalification. The vaccines will have a ceiling price of US$3 per dose, a price enabled by investments made by partners such as the Coalition for Epidemic Preparedness Innovations (CEPI), the Bill and Melinda Gates Foundation and SII. ]]> <![CDATA[IIL points out deep rooted situation of rabies in India]]> https://biospectrumindia.com/news/95/17288/iil-points-out-deep-rooted-situation-of-rabies-in-india.html https://biospectrumindia.com/news/95/17288/iil-points-out-deep-rooted-situation-of-rabies-in-india.html Tue, 29 Sep 2020 00:00:00 +0530 Rabies is an infectious viral disease that is fatal by the time its symptoms start appearing after an animal bite. The WHO estimates the death toll caused by Rabies in India at about 1 lac in the last 5 years with more than 1/3rd (36%) of the total deaths across the globe. Every year in the world, 90% of Rabies deaths occur in the children living in rural areas of Africa and Asia while coming into contact with infected dogs. The number of Rabies deaths are still much above than COVID-19 related deaths reported so far (94,500 as on Sep 27). Hyderabad based Indian Immunologicals Limited (IIL), a leading biologicals company, organized a virtual session to address the issue with eminent heath experts on the occasion of World Rabies Day (Sept 28). The situation is deep-rooted in India due to the lack of awareness of preventive measures, uncontrolled canine population, insufficient dog vaccination, poor knowledge of proper post-exposure prophylaxis. The webinar on the topic of ‘Managing Animal Bites Better – Lets Collaborate, Educate and Vaccinated’ discussed on these issues. While speaking on the handing Rabies, Dr. K. Anand Kumar, Managing Director, Indian Immunologicals Limited said, “IIL is truly a One Health company, playing a significant role in eradicating and providing cost-effective tools for the control of various zoonotic diseases in the country including the dreaded Rabies. As we move ahead there is an acute need of increasing the awareness level among the population at large. On World Rabies Day, several organizations come forward to intensify actions for the awareness of Rabies. IIL’s initiative of ‘Fearless Against Rabies’ is well set to reach out to a larger population on the awareness of preventive measures for rabies.” “Indian Immunologicals has been a pioneer in making anti-rabies vaccine accessible for both humans and animals. IIL is one of the world’s largest producers of rabies vaccines and consistent supply of “Abhayrab” anti-rabies vaccine has helped reduce the burden of this deadly disease. This has been possible due to our committed people, wide and robust distribution network, and highly efficient manufacturing and quality systems ,” added Dr. Prasanna Deshpande, Deputy Managing Director, Indian Immunologicals Limited. ]]> <![CDATA[I2Pure launches hand hygiene solution with iodine in India]]> https://biospectrumindia.com/news/95/17291/i2pure-launches-hand-hygiene-solution-with-iodine-in-india.html https://biospectrumindia.com/news/95/17291/i2pure-launches-hand-hygiene-solution-with-iodine-in-india.html Tue, 29 Sep 2020 00:00:00 +0530 In the wake of a global pandemic, I2Pure, a US based biotechnology company that has harnessed the biocidal properties of molecular iodine, has launched I2Cure in India. I2Cure is a ‘Make in India’ product for the world with production facilities in Haridwar, Roorkee and Baddi (Himachal). It is priced at Rs 388. I2cure comes from the mind of Dr Jack Kessler (Father of I2) and is an FDA Compliant, ISO 9001:2015, and WHO GMP certified product. Dr. Jack Kessler has approx. 26 patents for his inventions [This number includes patent applications that are pending as well as patents that have already been granted by the United States Patent and Trademark Office (USPTO)]. I2Cure is a bio-shield antiseptic lotion and an easy, single-use broad-spectrum antimicrobial that provides the protection of iodine against COVID-19. Unlike the alcohol-based sanitizers, I2Cure provides 12-hour, fool-proof protection against viral, bacterial, and fungal threats. Moreover, iodine nourishes and hydrates the skin as opposed to dry and cracked skin from alcohol-based products. Speaking on the launch, Dr. Jack Kessler (The Inventor of I2Cure) said, “I2Cure was established with a mission to provide the world with a product that gave more than just a short-term, superficial protection against germs and microbes. In order to accomplish this feat, we have created a formulation that has evolved with years of research to give us an edge over our faceless, microscopic enemy. I2Cure stands apart from other quick-fix topical disinfectants in that it uses molecular iodine, rather than abrasive alcohol, to protect your skin. I2Cure's patented molecular iodine formulation is actually absorbed into the skin and then is released as a vapor which transforms the skin of your hands into an antimicrobial material for up to 12 hours." Adding to this, Douglas Spitz (Chief Executive Officer, I2Cure) said, “We are constantly striving towards formulating solutions that evolve to get the edge over our faceless, microscopic enemies. At I2Cure, we wanted to bring about a revolution. A solution to the hand-safety conundrum and we did. We developed a topical disinfectant with molecular iodine as the active ingredient. Iodine has been one of the oldest and most effective antimicrobial agents in medical practice. We have taken iodine's efficacy a step further by delivering free molecular iodine into the skin. Moreover, there is no bacteria or virus resistant to iodine, so no drug-resistant pathogens are created.” Molecular iodine is the active agent in I2Cure. Molecular iodine has the ability to enter your skin, leaving no stain or smell. This prevents it from being washed away or rubbed off. ]]> <![CDATA[Indira IVF adds 4 new centres in tier-III cities]]> https://biospectrumindia.com/news/95/17282/indira-ivf-adds-4-new-centres-in-tier-iii-cities.html https://biospectrumindia.com/news/95/17282/indira-ivf-adds-4-new-centres-in-tier-iii-cities.html Mon, 28 Sep 2020 17:35:00 +0530 Mumbai based Indira IVF, the largest player in the infertility treatment space in India, in its efforts to provide affordable and best in class treatment to couples seeking infertility treatment has recently added four new centres in Tier-III cities namely, Nanded, Warangal, Sirsa and Gulbarga in the first half of FY20-21. The infertility specialist clinics chain now runs 92 centres across the country helping desirous couples fulfil their dream of parenthood. Indira IVF’s intent for their patients' wellbeing goes beyond their reproductive health, and hence, abiding by the guidelines laid by the government, the organization had shut down all their treatment centres for over two months. On June 3, 2020, Indira IVF once again opened its doors to aspiring couples and is optimistic that the pre-COVID volume of IVF procedures will restore by December this year. Currently, all Indira IVF centres strictly adhere to government protocols of running the centres and ensures that the utmost safety standards are maintained for their staff and patients visiting the clinic.  Indira IVF today is the largest and most recognized fertility chain of hospitals in the country. Armed with state-of-the-art infrastructure, Indira IVF helps countless couples navigate the often-complicated journey of infertility and ultimately realize their dream of starting a family. ]]> <![CDATA[Dr Reddy's announces launch of dimethyl fumarate capsules in US]]> https://biospectrumindia.com/news/95/17280/dr-reddys-announces-launch-of-dimethyl-fumarate-capsules-in-us.html https://biospectrumindia.com/news/95/17280/dr-reddys-announces-launch-of-dimethyl-fumarate-capsules-in-us.html Mon, 28 Sep 2020 13:25:00 +0530 Hyderabad based Dr Reddy’s Laboratories Ltd., along with its subsidiaries together referred to as (“DrReddy’s”) have recently announced the launch of Dimethyl Fumarate Delayed-Release Capsules, a therapeutic equivalent generic version of Tecfidera® (dimethyl fumarate) Delayed-Release Capsules, approved by the US Food and Drug Administration (USFDA). The Tecfidera® brand and the generic market had U.S. sales of approximately $3.8 billion MAT for the most recent twelve months ending in June 2020 according to IQVIA Health*. Dr Reddy’s dimethyl fumarate delayed-release capsules are available in 120 mg and 240 mg. Tecfidera® is a trademark of Biogen. ]]> <![CDATA[Indoco Remedies launches Favipiravir 400 mg in India]]> https://biospectrumindia.com/news/95/17279/indoco-remedies-launches-favipiravir-400-mg-in-india.html https://biospectrumindia.com/news/95/17279/indoco-remedies-launches-favipiravir-400-mg-in-india.html Mon, 28 Sep 2020 00:00:00 +0530 Mumbai based Indoco Remedies has announced the launch of FEVINDO (Favipiravir) 400 mg Tablets in India. Fevindo - 400 (Favipiravir) is an antiviral drug, effective against the RNA-based influenza virus. The drug has been approved by DCGI in the treatment of Covid-19. Fevindo 400 reduces pill burden by 50% and ensures convenient dosing and better patient compliance. Aditi Kare Panandikar, Managing Director - Indoco Remedies Ltd. commented, “The Covid-19 crisis has created vast disruption to life in India and all over the globe. As part of pharma industry, we have been able to do our bit in prevention of Covid-19 with our brands Karvol Plus, ATM, Febrex Plus and Rexidin SRS Mouthwash. With the launch of FEVINDO, we are taking the next step from prevention to the treatment of Covid-19.” Fevindo - 400 (Favipiravir) will be made available at all government approved COVID care centres and selected medical practitioners across the country. In addition to Fevindo, Indoco has two more new products for launch in Covid Care range, i.e., Povidone Iodine Gargle and Immunity booster chewable tablets with Zinc, Vitamin C and Vitamin D. ]]> <![CDATA[Aequs launches low cost mechanical resuscitator]]> https://biospectrumindia.com/news/95/17266/aequs-launches-low-cost-mechanical-resuscitator.html https://biospectrumindia.com/news/95/17266/aequs-launches-low-cost-mechanical-resuscitator.html Thu, 24 Sep 2020 14:35:00 +0530 Aequs, based in Belagavi, one of India's leading aerospace precision engineering and manufacturing company, has announced the launch of AQoventTM, a medical-grade, low-cost, and mass-produced mechanical resuscitator.  AQoventTM is an oxygen-driven emergency resuscitator that can provide constant-flow, pressure-cycled ventilation automatically to patients in respiratory distress.  Aequs is manufacturing these resuscitators in India based on the license procured on the concept design from the University of Illinois, U.S.A. Aequs has stepped up to leverage its ‘Aerospace’ and ‘Consumer Divisions' capabilities in its vertically integrated ecosystem at the Special Economic Zone in Belagavi, Karnataka, to manufacture AQoventTM A dedicated team of cross-functional engineers at Aequs has pooled in their collective expertise to manufacture AQoventTM.  AQoventTM operates directly of oxygen, making it ideal for deployment in non-electriﬁed locations (also in an ambulance as it is portable) and in situations with limited medical facilities. These single-use resuscitators are compact and easily deployable for treating patients affected by the virus and other respiratory conditions.  As one of the leading manufacturing partners of global OEMs such as Airbus, Boeing, Collins Aerospace, SAFRAN, among others, Aequs specializes in high-level precision engineering and ensures 'zero-defect' product quality. The company has committed to deliver 2,000 units per month to start with and is looking at a phased distribution to Government Hospitals, Health Authorities, Government e-Sourcing platforms, Ambulance Services and NGO's in Tier II & Tier III markets across Karnataka. The distribution plan for AQoventTM follows a not-for-profit model. Following the surge in demand, the company intends to scale up its production to 10,000 units per month.  ]]> <![CDATA[Panacea Biotec completes Ph I/II study of dengue vaccine candidate]]> https://biospectrumindia.com/news/95/17267/panacea-biotec-completes-ph-i-ii-study-of-dengue-vaccine-candidate.html https://biospectrumindia.com/news/95/17267/panacea-biotec-completes-ph-i-ii-study-of-dengue-vaccine-candidate.html Thu, 24 Sep 2020 02:10:00 +0530 Panacea Biotec has announced successful completion of its Phase I/II study to evaluate the safety and immunogenicity of its vaccine, DengiAll, a single-dose live-attenuated tetravalent vaccine. Speaking on the occasion, Dr Rajesh Jain, Managing Director, said “DengiAll’s Phase I/II study results are even more important in the context of the Covid-19 pandemic. Co-infection of Dengue and Covid-19 in a Dengue endemic India may complicate approach to treatment and strain healthcare infrastructure. Panacea Biotec has already approached the DGCI to seek accelerated review of its data to bring DengiAll to market quickly and reduce burden on our healthcare infrastructure.” Dr Lalitendu Mohanty, Head of Clinical Research, said, “Dengue fever’s unique characteristics make vaccine development tricky and an ideal Dengue vaccine must be safe and offer balanced and robust immune response against all four Dengue serotypes. This is where, we believe that DengiAll has shown promising results. I would like to thank virologist Dr. Steven Whitehead and the team at the National Institute of Allergy and Infectious Disease, US and infectious disease specialist Dr. Anna Durbin at the John Hopkins School of Public Health for their continued and unfettered support in this journey to bring DengiAll to market.” Devender Gupta, Chief Financial Officer, said, “We would like to thank Technology Development Board, Ministry of Science and Technology for supporting Panacea Biotec through financial and technical resources to make DengiAll’s Phase I/II a success.” DengiAll has illustrated the strength of Panacea Biotec’s expertise in vaccinology, research, development, and manufacturing while leveraging NIH’s ability to work on complex biological challenges to develop breakthrough technologies. New Delhi based Panacea Biotec through continued support from National Institutes of Health, Technology Development Board, and other stakeholders is in a better position to increase affordable access to DengiAll to fight Dengue, a disease that has eluded mankind for generations. With more than 3.9 billion people living in Dengue endemic areas and over 390 million infections per year, DengiAll targets a global market of over $3 billion. ]]> <![CDATA[IICT partners with Mylan to identify COVID-19 therapies]]> https://biospectrumindia.com/news/95/17259/iict-partners-with-mylan-to-identify-covid-19-therapies.html https://biospectrumindia.com/news/95/17259/iict-partners-with-mylan-to-identify-covid-19-therapies.html Thu, 24 Sep 2020 00:00:00 +0530 The Council of Scientific & Industrial Research (CSIR) and Mylan Laboratories Limited, the India-based subsidiary of leading global pharmaceutical company Mylan, have announced a partnership to address unmet patient needs amidst the evolving COVID-19 pandemic. Under the partnership, CSIR’s constituent laboratory Indian Institute of Chemical Technology (CSIR-IICT), and Mylan will collaborate to identify potential therapies for COVID-19. A series of clinical trials will be conducted towards new and innovative solutions to manage COVID-19 pandemic in India as part of this collaboration. The first of the clinical trial to be rolled out is a multiple arm phase 3 study that will be conducted in adult patients with mild to moderate COVID -19 at risk of complications. Director General of CSIR, Dr. Shehkar C Mande stated, “The current collaboration with Mylan is a significant milestone and during the current COVID-19 pandemic, CSIR has prioritized conducting clinical trials of well proven drugs in partnership with industry towards the development of multiple therapeutic options for COVID-19.” Director of CSIR-IICT, Dr Chandrasekhar said, “CSIR is delighted to associate with Mylan as knowledge and scientific partner, and looks forward to working with the company, especially given Mylan’s vast industry experience in clinical trials and commercialization.” Mylan Chief Operating Officer, Sanjeev Sethi stated, “Our collaboration with CSIR is a strategic step forward aimed at identifying effective treatments for patients with COVID-19. In addition to bringing forward new indications, this partnership will also help us identify multiple molecules that can potentially be leveraged in therapies for various other infectious diseases in the future.” The application for the clinical trials has been submitted to the Drugs Controller General of India (DCGI) for regulatory approval. CSIR has appointed Dr. Ram Vishwakarma, Honorary Advisor to DG-CSIR and former Director CSIR-IIIM (Indian Institute of Integrative Medicine) as a mentor to lead this collaboration. ]]> <![CDATA[Bayer’s Eylea receives DCGI approval for diabetic macular edema treatment]]> https://biospectrumindia.com/news/95/17253/bayers-eylea-receives-dcgi-approval-for-diabetic-macular-edema-treatment.html https://biospectrumindia.com/news/95/17253/bayers-eylea-receives-dcgi-approval-for-diabetic-macular-edema-treatment.html Wed, 23 Sep 2020 12:55:00 +0530 Bayer has recently announced that the Drugs Controller General of India (DCGI) has approved a new indication for intravitreal Aflibercept (EyleaTM) injection solution to treat Diabetic Macular Edema (DME). The approval of Aflibercept injection for intravitreal use presents a new and alternative treatment option to currently available therapies, for patients with DME. India is estimated to have the second-highest number of diabetes cases in the world, with 77 million cases projected to grow to more than 100 million cases by 2030. Diabetic macular edema (DME) is the most common cause of moderate vision loss in patients with diabetic eye diseases and is expected to affect 22.4 million Indians within the next two decades. Dr Shobhit Chawla, Sr Vitreo-Retina Consultant, Lucknow and President, Vitreo-Retina Society of India said, “Based on existing medical literature, we can estimate that diabetic eye disease is found approximately in every fifth person living with diabetes in urban India, and every tenth person living with diabetes in rural India. However, very few diabetic patients get screened proactively. The current pandemic has exacerbated this situation, with many patients waiting until symptoms of vision loss worsen.  Manoj Saxena, Managing Director Bayer Zydus Pharma said, “India has a large and growing prevalence of diabetes, coupled with low levels of awareness and diagnosis of vision-related complications resulting from the condition. Since a significant number of people living with diabetes are under 50, are working and may have dependent families, the economic and social burden of such complications is high. Intravitreal Aflibercept (EyleaTM) offers patients impacted by diabetic vision loss a new option to be proactive and stay ahead of the disease, thereby allowing patients to maintain their vision and to continue to participate in important daily activities such as reading, working and driving.” ]]> <![CDATA[Bharat Biotech advances COVID-19 intranasal vaccine technology]]> https://biospectrumindia.com/news/95/17252/bharat-biotech-advances-covid-19-intranasal-vaccine-technology.html https://biospectrumindia.com/news/95/17252/bharat-biotech-advances-covid-19-intranasal-vaccine-technology.html Wed, 23 Sep 2020 02:10:00 +0530 Bharat Biotech has announced a licensing agreement with Washington University School of Medicine in St. Louis for a novel chimp-adenovirus, single dose intranasal vaccine for COVID-19. Hyderabad based Bharat Biotech owns the rights to distribute the vaccine in all markets except USA, Japan and Europe. While the Phase I trials will take place in Saint Louis University’s Vaccine & Treatment Evaluation Unit, Bharat Biotech, upon obtaining the required regulatory approval, will pursue further stages of clinical trials in India and undertake large scale manufacture of the vaccine at its GMP facility located in Genome Valley, Hyderabad. "We are proud to collaborate on this innovative vaccine. We envision that we will scale this vaccine to 1 billion doses, translating to 1 billion individuals vaccinated receiving a single-dose regimen. An intranasal vaccine will not only be simple to administer but reduce the use of medical consumables such as needles, syringes, etc., significantly impacting the overall cost of a vaccination drive. Our experience in viral vaccines, manufacturing capabilities, and distribution continue to be our strong suit in ensuring safe, efficacious, and affordable vaccines. It is prudent for Bharat to be involved in diverse but tenable projects to provide a much-needed vaccine against COVID-19 reaches all citizens of the world.” Dr. Krishna Ella, Chairman and Managing Director of Bharat Biotech, stated. This intranasal vaccine candidate has shown unprecedented levels of protection in mice studies; the technology and data having been recently published in the prestigious scientific journal Cell and in an editorial in Nature. Dr. David T. Curiel, MD, Ph.D., Director of Biologic Therapeutics Center and Professor of Radiation Oncology at Washington University School of Medicine in St. Louis and Precision Virologics Interim CEO said, “The ability to accomplish effective immunization with a single nasal dose is a major advantage, offering broader reach and easier administration. An effective nasal dose not only protects against COVID-19, but it also prevents the spread of the disease by offering another kind of immunity that occurs primarily in the cells that line the nose and throat. Most other vaccine candidates currently under development can’t do that.” This vaccine expands Bharat’s portfolio of vaccines that are currently being developed and are in various stages of clinical development including COVAXIN® which is currently in Phase II human clinical trials in India. ]]> <![CDATA[Hester Bio acquires Brucella vaccine technology from IVRI]]> https://biospectrumindia.com/news/95/17256/hester-bio-acquires-brucella-vaccine-technology-from-ivri.html https://biospectrumindia.com/news/95/17256/hester-bio-acquires-brucella-vaccine-technology-from-ivri.html Wed, 23 Sep 2020 01:00:00 +0530 Hester Biosciences has signed the agreement towards receiving the indigenously developed technology from ICAR-IVRI (Indian Council of Agriculture Research – Indian Veterinary Research Institute), for developing the Brucella Abortus S19 Delta Per vaccine. The agreement was signed through video conferencing on 22 September 2020. While Ahmedabad based Hester is currently manufacturing the conventional Brucella Abortus S19 vaccine and supplying to all the states in India, the S19 Delta Per new generation vaccine technology developed by IVRI will be a step forward towards developing a Brucella vaccine with enhanced safety, immunogenicity, as well as assuring lifelong immunity with a single shot in calf-hood.  The Government of India has planned to immunize 4 crore female calves in India in the first phase against Brucella through vaccination. Hester has been and commits to remain a part of the Government of India’s immunization program against Brucella in cattle. With this vaccine Hester hopes to reach new heights not only within India but also become a channel for immunizing cattle against Brucella, worldwide. The technology is developed by Dr. Pallab Chaudhari and his team from ICAR-IVRI through their relentless efforts as well as support from Biotech Consortium India Limited and The Department of Biotechnology (DBT), Government of India. Brucella is a disease of economic importance worldwide. Not only does it impact cattle, sheep, goat and swine, but it also gets transmitted to human beings. Incidentally there is no vaccine available to protect humans against Brucella. The animals need to be protected to protect mankind. Immunization with Brucella vaccine also helps cattle to remain healthy, thereby improving their milk production.  Hester hopes to launch the Brucella Abortus S19 Delta Per vaccine in 18 months. ]]> <![CDATA[BDR Pharma launches prostate cancer drug in India]]> https://biospectrumindia.com/news/95/17245/bdr-pharma-launches-prostate-cancer-drug-in-india.html https://biospectrumindia.com/news/95/17245/bdr-pharma-launches-prostate-cancer-drug-in-india.html Tue, 22 Sep 2020 00:00:00 +0530 BDR Pharmaceutical in Mumbai has announced the launch of 80mg advanced version of its Enzalutamide drug. BDR Pharma had earlier received approval from the Drugs Controller General of India (DCGI) to manufacture 40mg Enzalutamide in 2017 to treat men with metastatic castration-resistant prostate cancer (mCRPC) under the brand name BDENZA. The 80 mg version is an attempt to reduce the pill burden that has been a demand from doctors and patients to be used for the treatment of mCRPC. Reducing the pill burden is expected to increase the patient compliance. “At BDR Pharma, we aim to introduce innovative treatment options that will benefit cancer patients and improve their overall standard of care. This launch further strengthens our commitment to provide affordable and accessible treatment options for patients with prostate cancer in India. The approval for 80mg dosage of enzalutamide brings us a step closer to our goal of reducing the risk and progression of the disease and making it convenient for the patients to manage their dosage,” says Dharmesh Shah, CMD, BDR Pharma.  BDR Pharma was the first to manufacture and market enzalutamide in India in 2017 after being tested on 7000+ patients in different clinical settings. The potency of BDENZA was looked based on its potential to reduce the PSA levels by >50% compared to the baseline values among patients of metastatic prostate cancer. The results of our trail demonstrated a significant improvement in patients with nmCRPC who were treated with BDENZA 80mg.  ]]> <![CDATA[Bdiapers launches India's first hybrid cloth diapers with disposable inserts]]> https://biospectrumindia.com/news/95/17230/bdiapers-launches-indias-first-hybrid-cloth-diapers-with-disposable-inserts.html https://biospectrumindia.com/news/95/17230/bdiapers-launches-indias-first-hybrid-cloth-diapers-with-disposable-inserts.html Fri, 18 Sep 2020 11:25:00 +0530 Bangalore based Bdiapers has recently launched India’s 1st and only cloth diapers cover with chemical-free disposable nappy pads. Bdiapers has a patented design of diapers that provide the health of cloth and the convenience of disposables in a single diaper that is affordable, eco-friendly and trendy.   Hybrid Diapers are simply cloth shell covers with disposable or reusable inserts. Bdiapers is a patented design of hybrid diaper that works in a 2-part system with a cloth cover and a waterproof pouch that holds the disposable nappy pad. The cloth part being purely ornamental doesn’t need a wash until soiled. The waterproof pouch that holds the reusable or disposable inserts are leak-proof and unlike plastic, they not ‘crack’ over several hundreds of washes. The pouch helps separate the “cloth” from the “diaper” making it as close as possible to a disposable. The disposable inserts sold with the covers are bleach, fragrance and dye-free making them hypoallergic and easy on the baby’s delicate skin. Each and every aspect of the diaper is carefully designed stressing on safety and comfort.   Bdiapers Hybrid Diapers mimic the functionality of a disposable diaper while reducing the exposure to chemicals for babies and thereby the chance of rashes and allergies. The shell covers come in sizes from S to XL, and the company has a large pack of disposables inserts refills for moms who like to save. ]]> <![CDATA[Roche drug reduces need for mechanical ventilation in COVID-19 patients]]> https://biospectrumindia.com/news/95/17232/roche-drug-reduces-need-for-mechanical-ventilation-in-covid-19-patients.html https://biospectrumindia.com/news/95/17232/roche-drug-reduces-need-for-mechanical-ventilation-in-covid-19-patients.html Fri, 18 Sep 2020 02:10:00 +0530 Roche has announced that the phase III EMPACTA study met its primary endpoint, showing that patients with COVID-19 associated pneumonia who received Actemra®/RoActemra® (tocilizumab) plus standard of care were 44% less likely to progress to mechanical ventilation or death compared to patients who received placebo plus standard of care (log-rank p-value = 0.0348; HR [95% CI] = 0.56 [0.32, 0.97]). The cumulative proportion of patients who progressed to mechanical ventilation or death by day 28 was 12.2% in the Actemra/RoActemra arm versus 19.3% in the placebo arm. The EMPACTA study did not identify any new safety signals for Actemra/RoActemra. The study is the first global, phase III COVID-19 clinical trial to primarily enrol patient populations that are often underrepresented in clinical studies and have been disproportionately affected by the COVID-19 pandemic. Approximately 85% of the 389 patients were from minority racial and ethnic groups. The majority of patients were Hispanic, with significant representation of Native American and Black populations. The trial was conducted in the United States, South Africa, Kenya, Brazil, Mexico and Peru. “We have been striving to improve inclusion and diversity in our trials,” said Jamie Freedman, M.D., Ph.D., Head of U.S. Medical Affairs. “During the COVID-19 pandemic, we saw how high the stakes were for many communities of colour and made diversity the centerpiece of this trial.” ]]> <![CDATA[Fujifilm India enhances disease management & prognosis of Covid-19 ]]> https://biospectrumindia.com/news/95/17226/fujifilm-india-enhances-disease-management-prognosis-of-covid-19-.html https://biospectrumindia.com/news/95/17226/fujifilm-india-enhances-disease-management-prognosis-of-covid-19-.html Thu, 17 Sep 2020 16:45:00 +0530 Fujifilm India Private Limited, a pioneer in imaging and healthcare technologies, in line with its commitment to provide aid for the unprecedented crisis, has been strengthening its pledge to contribute to healthcare experts with the help of its progressive Dri Chemistry solutions that can aid LDH and CRP testing in just 6 minutes.  Recent research suggests that relatively high levels of LDH alone seem to play a crucial role in distinguishing the vast majority of cases that require immediate medical attention. This finding is consistent with current medical knowledge that high LDH levels are associated with tissue breakdown occurring in various diseases, including pulmonary disorders such as pneumonia. The use of the biomarkers suggests a simple and operable decision rule to quickly predict patients at the highest risk, allowing them to be prioritized and potentially reducing the mortality rate. With Fujifilm’s dry chemistry analyzer, healthcare professionals can perform multiple test parameters of Clinical Chemistry. It has a built-in auto-pipetting system, requires no calibration and no water, providing easy preparation and maintenance. The new FUJI DRI-CHEM NX500i and NX700i deliver results using a simple 3-step procedure. With its quick, easy operation and compactness, ‘Real Time and Borderless’ Clinical Chemistry has now been made possible. The clinical chemistry solutions deliver fine chemical technology which is Japanese patented technology for the manufacturing of Dri Chemistry Slides. Further, with plug and play equipment, the NX500i can run up to 128 tests per hour and the NX700i can run upto 190 tests per hour respectively. ]]> <![CDATA[Doceree streamlines physician marketing with new solution]]> https://biospectrumindia.com/news/95/17220/doceree-streamlines-physician-marketing-with-new-solution.html https://biospectrumindia.com/news/95/17220/doceree-streamlines-physician-marketing-with-new-solution.html Thu, 17 Sep 2020 11:45:00 +0530 Doceree, the 1st global network of physician-only platforms for programmatic marketing has recently launched India’s 1st Integrated Programmatic Email Ad-serving solution for Physicians, a product that brings in huge credibility in email marketing and promises to significantly enhance the performance of email campaigns.  With the launch of Doceree DirectTM, the company, which is the World’s Largest Programmatic Physician Engagement Platform, has expanded its product offering in India. Physician marketing in the country is scattered and the announcement of programmatic email ad serving solution is yet another attempt by Doceree to streamline the landscape.   World over, email marketing is a preferred mode of business communication with 73% of marketers choosing it to engage with their audience on a daily basis. But majority of the emails are not even opened once.   The company while analyzing the reasons for low output of email marketing efforts of Pharma brands surmised that credibility of the sender plays an important role in the opening rates and effectiveness of any emailer campaign.   Doceree DirectTM will not only ensure that messages sent by Rx drug brands are delivered into the inbox of Physicians, it will also help build an all-new source of revenue generation for doctor-only platforms.   The company had launched its India operations in March 2020.     ]]> <![CDATA[Dr Reddy’s to supply 100 M doses of Sputnik V vaccine to India]]> https://biospectrumindia.com/news/95/17221/dr-reddys-to-supply-100-m-doses-of-sputnik-v-vaccine-to-india.html https://biospectrumindia.com/news/95/17221/dr-reddys-to-supply-100-m-doses-of-sputnik-v-vaccine-to-india.html Thu, 17 Sep 2020 01:05:00 +0530 The Russian Direct Investment Fund (RDIF), Russia’s sovereign wealth fund, and Dr. Reddy’s Laboratories Ltd. (Dr. Reddy’s), a global pharmaceutical company headquartered in Hyderabad, have agreed to cooperate on clinical trials and distribution of Sputnik V vaccine in India. Upon regulatory approval in India, RDIF shall supply to Dr. Reddy’s 100 million doses of the vaccine. The Sputnik V vaccine, which is based on wellstudied human adenoviral vector platform with proven safety, is undergoing clinical trials for the coronavirus pandemic. Deliveries could potentially begin in late 2020 subject to completion of successful trials and registration of the vaccine by regulatory authorities in India. The agreement between RDIF and Dr Reddy’s reflects the growing awareness of countries and organizations to have a diversified anti-COVID vaccine portfolio to protect their populations. G V Prasad, Co-Chairman & Managing Director of Dr. Reddy’s Laboratories said, “We are pleased to partner with RDIF to bring the vaccine to India. The Phase I and II clinical trials have shown promising results. We will be conducting Phase-III trials in India to ensure safety and efficacy for the Indian population and to meet the requirements of the Indian regulators. Sputnik V vaccine could provide a credible option in our fight against COVID 19 in India.” On August 11, the Sputnik V vaccine developed by the Gamaleya National Research Institute of Epidemiology and Microbiology was registered by the Ministry of Health of Russia and became the world’s first registered vaccine against COVID-19 based on the human adenoviral vectors platform. Detailed information on the Sputnik V vaccine, the technological platform of human adenoviral vectors, and other details are available at sputnikvaccine.com On September 4, a research paper on the results of Phase I and Phase II clinical trials of the Sputnik V vaccine was published in The Lancet, one of the leading international medical journals, demonstrating no serious adverse effects and a stable immune response in 100% of participants. Post-registration clinical trials of the Sputnik V vaccine involving 40,000 volunteers are currently ongoing. More than 55,000 volunteers have applied to take part in post-registration trials. The first results of these trials are expected to be published in October-November 2020. ]]> <![CDATA[Serum Institute to manufacture 1 B doses of Novavax COVID-19 vaccine in 2021]]> https://biospectrumindia.com/news/95/17222/serum-institute-to-manufacture-1-b-doses-of-novavax-covid-19-vaccine-in-2021.html https://biospectrumindia.com/news/95/17222/serum-institute-to-manufacture-1-b-doses-of-novavax-covid-19-vaccine-in-2021.html Thu, 17 Sep 2020 01:05:00 +0530 Novavax, Inc., a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases in the US, has announced an amendment to its existing agreement with Pune based Serum Institute of India Private Limited (SIIPL) under which SIIPL will also manufacture the antigen component of NVX‑CoV2373, Novavax’ COVID‑19 vaccine candidate. With this agreement, Novavax increases its manufacturing capacity of NVX-CoV2373 to over two billion doses annually, when all planned capacity has been brought online by mid-2021. NVX‑CoV2373 is a stable, prefusion protein made using Novavax’ recombinant protein nanoparticle technology and includes Novavax’ proprietary Matrix‑M™ adjuvant. “Today’s agreement with Serum Institute enhances Novavax’ commitment to equitable global delivery of our COVID-19 vaccine. With this arrangement, we have now put in place a global supply chain that includes the recently acquired Praha Vaccines and partnerships with leading biologics manufacturers, enabling production on three continents,” said Stanley C. Erck, President and Chief Executive Officer of Novavax. “We continue to work with extraordinary urgency to develop our vaccine, now in Phase 2 clinical trials, and for which we anticipate starting Phase 3 efficacy trials around the world in the coming weeks.” The agreement with SIIPL augments a global supply chain that will deliver over two billion doses of NVX-CoV2373 annually as of 2021.  The antigen component of NVX-CoV2373 is being manufactured at Novavax CZ in Bohumil, Czech Republic (formerly Praha Vaccines), as well as at the following partnered manufacturing sites: Biofabri in Spain FUJIFILM Diosynth Biotechnologies (FDB) in both North Carolina and Texas in the United States FDB in the United Kingdom SIIPL in India SK Bioscience in the Republic of Korea Takeda Pharmaceutical Company Limited in Japan ]]> <![CDATA[Aurobindo Pharma setting up COVID-19 vaccine manufacturing platform]]> https://biospectrumindia.com/news/95/17215/aurobindo-pharma-setting-up-covid-19-vaccine-manufacturing-platform.html https://biospectrumindia.com/news/95/17215/aurobindo-pharma-setting-up-covid-19-vaccine-manufacturing-platform.html Wed, 16 Sep 2020 01:05:00 +0530 Biotechnology Industry Research Assistance Council (BIRAC), set up by Department of Biotechnology (DBT), Government of India is supporting COVID-19 vaccine development by facilitating  the establishment of the r-VSV vaccine manufacturing platform for the first time in India under the National Biopharma Mission. This support to establishing r-VSV vaccine manufacturing platform is being extended to Aurobindo Pharma Limited in Hyderabad which is developing a vaccine for SARS COV-2 (COVID-19). This SARS COV-2 vaccine candidate is based on the company’s proprietary replication-competent, attenuated, recombinant vesicular stomatitis (VSV, VesiculoVax™) vaccine delivery platform. Aurobindo is in the process of setting up a state-of-art manufacturing facility for viral vaccines which will be used to produce the COVID-19 vaccine and other viral vaccines.The plant will comply to global standards. Commenting on the collaboration with Aurobindo, Dr Renu Swarup, Secretary, DBT and Chairperson, BIRAC said, “The partnership with Aurobindo is to serve the country’s need for a vaccine to fight this pandemic. The government is focused on creating an ecosystem that nurtures and encourages new product innovation to address the most relevant issues to our society.” ]]> <![CDATA[Arvind Limited, ACT Grants to produce 30 M N95 masks in India]]> https://biospectrumindia.com/news/95/17211/arvind-limited-act-grants-to-produce-30-m-n95-masks-in-india.html https://biospectrumindia.com/news/95/17211/arvind-limited-act-grants-to-produce-30-m-n95-masks-in-india.html Wed, 16 Sep 2020 00:00:00 +0530 Bengaluru based textile company Arvind Limited and ACT Grants have partnered to produce 30 million N95 masks in the next 12 months. Arvind Limited has received a grant of Rs 100 million from ACT Grants, the non-profit coalition of VC funds and start-up founders, and will employ its manufacturing expertise on Medical Products and Working Capital to create a large, integrated facility for N95 mask production and distribution. Arvind and ACT Grants will jointly donate 9 million masks over the next year to charitable institutions, government bodies, and other organizations, focusing on medical and non-medical professionals with the highest risk of contracting the virus. The partnership is a swift response to PM Narendra Modi’s call to make wearing masks compulsory for the general public.  Upon complete scale-up, the daily N95 mask production capacity will be approximately 2 lakh units which would be operated, owned and managed by Arvind. This capacity would bridge the gap in supply and edge India towards self-sufficiency in N95 masks. The N95 masks will be available through Arvind Advanced Material Distribution partners, direct sales channels to Government, hospitals, and other corporates. Arvind Advanced Materials is a large, pioneering manufacturer of PPE Coveralls and Face Masks which are certified by BIS and Global agencies.  Apart from masks, Arvind also manufactures Protective Coveralls and Bio-Suits for medical practitioners and frontline warriors. Arvind has supplied more than 1 lakh coveralls so far to the Central and State Governments. ]]> <![CDATA[Johnson's unveils new Cottontouch range in India ]]> https://biospectrumindia.com/news/95/17202/johnsons-unveils-new-cottontouch-range-in-india-.html https://biospectrumindia.com/news/95/17202/johnsons-unveils-new-cottontouch-range-in-india-.html Mon, 14 Sep 2020 12:45:00 +0530 JOHNSON’S®, one of the world’s top healthcare companies has recently unveiled the innovative Cottontouch® range that is blended with natural cotton to provide the perfect way to care for a newborn’s delicate and sensitive skin. Exclusively launched on e-commerce, the new range of products comprises a wash, lotion, cream and oil and is available on platforms – Amazon, Flipkart, Big Basket, FirstCry, and Nykaa for the consumers.  JOHNSON’S® has a 125-year heritage of creating the safest products that moms have used with trust and confidence on their babies. This unique launch during these unprecedented times is an effort to address the increasing demand for efficacious products, based on science from trustworthy baby care brands in India. JOHNSON’S® has also onboarded over 700 influencers to welcome Cottontouch® in the Indian market. Cottontouch® is an innovative range, a result of intensive research and development. It is a world’s first in baby care products that are infused with natural cotton and formulated for zero irritation. The soft, absorbent and naturally hypoallergenic cotton is suspended for the softest experience.  The new Cottontouch® will be available in the retail stores in a few weeks. Manoj Gadgil, VP Marketing, Johnson & Johnson Consumer Division, India said, “We at JOHNSON’S® are known for our long-standing commitment towards safest baby care products that define what is best for baby. We have invested decades of research to understand baby skin and know the delicate skin of a newborn needs and deserves the gentlest care. That is why we are introducing Cottontouch® range that provides mothers with softness they have never experienced before. We have seen the demand for baby care significantly growing in the Indian market, even during lockdown phase and the ask from moms for the highest standard of safety in these times has inspired us to launch this product. We are hoping to reach out to as many parents possible through the e-commerce route and help them make their journey of parenthood more joyous.” ]]> <![CDATA[Granules receives USFDA approval for complex ADHD drug]]> https://biospectrumindia.com/news/95/17195/granules-receives-usfda-approval-for-complex-adhd-drug.html https://biospectrumindia.com/news/95/17195/granules-receives-usfda-approval-for-complex-adhd-drug.html Fri, 11 Sep 2020 14:05:00 +0530 Hyderabad based Granules, a world-leading APIs & formulations corporation recently announced its US subsidiary has received marketing approval from the U.S. Health Regulator (FDA) for Dexmethylphenidate HCl extended-release capsules for the treatment of attention-deficit hyperactivity disorder. Granules’ capsule product is bioequivalent to the reference listed drug (RLD), Focalin™ XR. Priyanka Chigurupati, Executive Director of Granules Pharmaceuticals Inc. said “This approval for Granules Pharmaceuticals Inc, received within 13 months of filing reiterates our strength in the development of complex generics. The approval of Dexmethylphenidate XR, a complex, extended-release C-II product, is a good addition to our portfolio. We will be launching the product in the US market soon.” The drug will be manufactured at the Granules manufacturing facility in Chantilly, Virginia. Granules now have a total of 30 ANDA approvals from the US FDA (28 Final approvals and 2 tentative approvals). According to IQVIA Health, Dexmethylphenidate HCl ER Capsules had U.S. sales of approximately $556 million for the most recent twelve months ending in July 2020. Focalin™ XR is a trademark of Novartis AG. ]]> <![CDATA[Sceptre Medical awarded as 'India's most admirable healthcare brand-2020' ]]> https://biospectrumindia.com/news/95/17191/sceptre-medical-awarded-as-indias-most-admirable-healthcare-brand-2020-.html https://biospectrumindia.com/news/95/17191/sceptre-medical-awarded-as-indias-most-admirable-healthcare-brand-2020-.html Fri, 11 Sep 2020 12:45:00 +0530 Sceptre Medical India, a leading manufacturer of antiseptic and disinfectants, has been awarded India's Most Admirable Healthcare Brand-2020 (Category: Emerging Healthcare Brands) for its impeccable contribution to the healthcare industry. Sceptre Medical India has emerged as one of the leading warriors during the Coronavirus pandemic. With a presence in antiseptics, wet wipes and disinfectants segments, Sceptre's product range includes hand hygiene and skin antiseptics, surface and environment disinfectants, instrument disinfectants, haemodialysis disinfectants, wet wipes, antiseptic swab stick for skin preparation, and other ancillary medical accessories. The Brand Story awarded Sceptre Medical India with India's Most Admirable Healthcare Brand-2020 for its unwavering efforts in achieving technical and technological competence, advanced products, prime focus on ethics and compliance, constant endeavour to commit to delivering its products and services.  Under the able leadership of Mr. Sanjay Manocha (Managing Director), Sceptre Medical, India Pvt. Ltd. has emerged as a market leader with a distribution network spreading all over India, and around the globe. Spectre has been a pioneer in the pharmaceutical and medical devices industry with its clients ranging over 65 hospitals like Max Healthcare, Fortis, Fresenius Medical Care, Apollo Hospitals, Rajiv Gandhi Cancer Institute and Research Centre. Spectre recently became one of the first pharmaceutical companies in the region to introduce a line of Ayurvedic disinfection products. Sceptre diversified its product offerings by adding Ayurvedic products like hand sanitizers, hand soaps, fruits and vegetables' cleaner, introduced with the sole aim of bringing effective sanitization and disinfection to homes. ]]> <![CDATA[PNB Vesper receives DCGI approval to test NCE PNB 001 in COVID-19 patients]]> https://biospectrumindia.com/news/95/17194/pnb-vesper-receives-dcgi-approval-to-test-nce-pnb-001-in-covid-19-patients.html https://biospectrumindia.com/news/95/17194/pnb-vesper-receives-dcgi-approval-to-test-nce-pnb-001-in-covid-19-patients.html Fri, 11 Sep 2020 01:05:00 +0530 PNB Vesper in Kochi has received approval from the Drug Controller General of India (DCGI) to conduct the Phase 2b Clinical trial of their propriety drug PNB-001 (GPP-Baladol®) in testing COVID-19 patients. PNB 001 may be the first New Chemical Entity (NCE) in the world for testing in COVID-19 patients. The company has filed the Clinical trial application with DCGI for the Phase 2 Clinical Trials and the study will be completed in 60 days. The study will be conducted in 40 Covid-19 positive patients at BMJ Medical College, Pune who are moderate patients on oxygen support.  The effect of PNB 001 will be compared with DEXAMETHASONE, currently the most popular medicine in COVID-19 treatment in the world. A larger population, approximately 350 Covid-19 patients will be enrolled Across the Country in 6 medical Colleges the Phase 3 Clinical trials  after reviewing the  phase 2 clinical trial results. The molecule has already been patented and the related Intellectual Property Rights (IPRs) have been secured by PNB VESPER in the US, Europe and rest of the world. As per the human Studies, GPP Baladol® (PNB-001) was found extremely safe in a PHASE 1 clinical trials with expected pharmacokinetics, and Pharmacodynamics leading to subsequent phase 2b /3 trials. It was tested in 74 healthy subjects at low, medium and high doses over a course of various periods. In the pre-clinical models, PNB-001 was found to be highly effective in inflammation compared with Steroids.  It was also found PNB 001 is twenty times more potent than Aspirin which is the gold standard for Pyrexia Studies. Further, the US FDA has shown interest in the drug and the discussions with USFDA are in the final stages.  Other than this, discussions have already been initiated with the UK Government to include PNB 001 in the ongoing COVID 19 clinical trials. PNB Vesper’s UK Scientific Team headed by Dr. Eric Lattmann is coordinating the UK developments. Highlighting the key findings of PNB – 001, Dr. Eric Lattmann, Vice President Research PNB VESPER said, “PNB-001 has been found to be twenty times more efficacious than Aspirin in the Antipyretic and Pain Studies. It has shown remarkable results in lung inflammation and ARDS (Acute Respiratory Distress Syndrome). In the Dengue Virus Viremia Model studies, PNB 001 reduced the mortality of animals significantly, almost 80% than the control group. It is also proved that the Cytokine storms and Spleen size reduced significantly. This means the mortality rate can be reduced considerably by using GPP Baladol”. Speaking on the breakthrough innovation, P N Balaram, CEO of PNB Vesper Life Pvt Ltd said, “This is indeed a very big step for mankind in its fight against the Covid-19 pandemic. Post the DCGI Permission, our initial clinical trials would be completed in 60 days. Considering the novel mechanism of our molecule, we expect much better results in the clinical trials compared with Dexamethasone.  In COVID-19, the main symptoms are Pyrexia, Body Pain and inflammation in the Lung and we lose patients mainly because of Cytokine Storms and ARDS. We have proved in the pre-clinical studies our drug is effective in reducing fever, body pain and inflammation. The drug GPP – Baladol has shown positive results in all the initial pre-clinical studies and we do hope that the final trials would prove the efficacy of the molecule in COVID-19 patients, which could lead to the manufacturing of the drug. PNB 001 is further found to be very effective in Small Cell Lung Cancer Xenograft and Allograft studies too.  If the molecule is found to work successfully in Covid-19 patients, PNB 001 may be the first new Chemical Entity in the world for COVID-19 treatment.” PNB Vesper has 6 molecules in various development stages targeting treatment for a number of health problems:  A CCK2 antagonist, is under development for the treatment of inflammatory pain, Arthritis and inflammatory bowel disease is in the phase 2 clinical trials. The clinical results will come out before September end 2020. PNB-028, a CCK isoform-selective antagonist is being developed for the treatment Pancreatic and Colon cancer is in the phase 2 a Clinical trials. The initial clinical studies will be completed before March 2021 PNB-081, a CK1 antagonist for the treatment of pain in conjunction with opioids and Pancreatitis is in the IND studies PNB-291 is in the Regulatory IND stage studies for neuroendocrine cancers ,Brain and Tripple resistant Breast Cancers PNB 291 found to be 20 times efficacious than TAMAZOLOMIDE and BCNU , the existing Brain Cancer molecules in the world  in the Xenograft and Alograft studies. PNB – 102 for Gastric Cancer and Small Cell Lung Cancer. ]]> <![CDATA[Sai Life Sciences expands suite of cellular analysis platforms]]> https://biospectrumindia.com/news/95/17190/sai-life-sciences-expands-suite-of-cellular-analysis-platforms.html https://biospectrumindia.com/news/95/17190/sai-life-sciences-expands-suite-of-cellular-analysis-platforms.html Fri, 11 Sep 2020 00:00:00 +0530 Hyderabad based Sai Life Sciences, one of India's fastest growing Contract Development & Manufacturing Organizations (CDMOs), has announced the addition of state-of-the-art cellular analysis platforms at its Discovery Biology facility in Cambridge, Massachusetts, USA.  Coinciding with its first anniversary in Cambridge, the expanded suite of capabilities include the Opera Phenix high content screening platform, FACSCelesta flow cytometer and FACSMelody flow sorter, enabling it to better serve start-up and biotech companies in the region, especially in projects exploring novel biology in oncology, neuroscience and rare diseases. Over the past year, the lab has delivered a range of projects including genetic and pharmacological target validation studies, reagent validation, and developed a variety of assays for its clients, such as cellular target engagement assays and in vitro biomarker assessments. Speaking about the company's plans, CEO & Managing Director of Sai Life Sciences, Krishna Kanumuri said, "We are committed to helping our clients successfully advance their internal discovery portfolios and are investing considerable resources to provide world-class service in the Boston area. These new capability additions are just the latest in our strategic growth plan with significant additional capabilities coming soon." The Cambridge lab serves as a vital bridge, enabling seamless integration with rest of the company's service offerings across UK and India, spanning the drug discovery and development continuum including medicinal chemistry, DMPK and toxicology, process chemistry and analytical development, and commercial scale manufacturing. ]]> <![CDATA[Hydraguard Plus to replace disinfectants during pandemic]]> https://biospectrumindia.com/news/95/17186/hydraguard-plus-to-replace-disinfectants-during-pandemic.html https://biospectrumindia.com/news/95/17186/hydraguard-plus-to-replace-disinfectants-during-pandemic.html Thu, 10 Sep 2020 15:10:00 +0530 Advanced NanoTech Lab, a specialty chemical manufacturer from Mumbai, has developed a durable antimicrobial nano coating branded as ‘Hydraguard Plus’ that lasts up to 90 days and can be extended up to 365 days. Antimicrobial coatings became the need of the hour to protect the surfaces and build structures from the virus. The antimicrobial coating has gained more relevance during the current time because of its safeguard and various other functions such as detection of coronavirus. Antimicrobials are generally understood to be chemical substances. Antimicrobial active substances also include ionizing radiation or technically produced surface structures. The antimicrobial coating is the best possible alternative to these chemically hazardous disinfectants to deal with the rapidly growing problem. Generally, the nanotechnology-based antimicrobial coating is very competent in killing bacteria and viruses. This technology is usually supported by different metal ions such as silver, gold, and other halides, etc. These ions can get attached to the film of cells and intervene with bacterial biotransformation to build pathogen-free surfaces.    The nanotechnology-based antimicrobial coating is one of the sustainable alternatives of chemically rich disinfectants.   HYDRAGUARD PLUS is a durable antimicrobial coating system that is non-toxic, transparent, nano-leaching, self-curing system, and its rare non-migrating technology works 24/7 to constrain bacteria's growth fungi, algae, infection on surfaces like glass, metal, plastic, stones, ceramic, etc. Even after 90 days, it can last without running thin its antiviral potency. It can kill 99.99 % of bacteria and viruses like E-bola, MS2, and many more for 90 days making disinfectants obsolete.   ]]> <![CDATA[Dr Reddy's unveils Redyx in India for COVID-19 treatment]]> https://biospectrumindia.com/news/95/17185/dr-reddys-unveils-redyx-in-india-for-covid-19-treatment.html https://biospectrumindia.com/news/95/17185/dr-reddys-unveils-redyx-in-india-for-covid-19-treatment.html Thu, 10 Sep 2020 00:00:00 +0530 Dr. Reddy’s Laboratories Ltd. has announced the launch of Remdesivir, under a brand name Redyx in India. The launch is part of the licensing agreement with Gilead Sciences, Inc. (Gilead) that grants Dr. Reddy’s the right to register, manufacture and sell Remdesivir, a potential treatment for Covid-19, in 127 countries including India. Remdesivir is approved by Drug Controller General of India (DCGI) for restricted emergency use in India for the treatment of Covid-19 patients hospitalized with severe symptoms. Dr. Reddy’s Redyx is available in strength of 100 mg vial. M V Ramana, Chief Executive Officer, Branded Markets (India and Emerging Markets), Dr. Reddy’s Laboratories, said "We will continue our efforts to develop products that address significant unmet needs of patients. The launch of Redyx reaffirms our commitment to bringing in critical medicine for patients suffering from Covid-19 in India.” ]]> <![CDATA[Dollar Industries, HealthGuard introduce anti-viral products ]]> https://biospectrumindia.com/news/95/17179/dollar-industries-healthguard-introduce-anti-viral-products-.html https://biospectrumindia.com/news/95/17179/dollar-industries-healthguard-introduce-anti-viral-products-.html Wed, 09 Sep 2020 14:55:00 +0530 Dollar Industries Limited, one of India’s leading brands based in Kolkata in the hosiery segment, has joined hands with Australia based company, HealthGuard and curated a new range of anti-viral products. The initial range consists of anti-viral masks and innerwear for men. The safe cosmetic based chemistry of HG AMIC is 100 per cent and skin-friendly and remains active on treated fabric achieving excellent wash performance.  Dollar Industries organized an insightful and knowledge-driven panel discussion, #DontBringTheVirusHome, on an e-platform recently. The brand addressed the best measures to protect oneself along with their loved ones. With a primary focus on #DontBringTheVirusHome, the panel discussion consisted of eminent medical practitioners - Dr Kunal Sarkar, Senior Vice-Chairman, Director and Head of Cardiac Surgery at Medica Superspeciality Hospital, Dr Uttiya Deb, Clinical Pharmacologist, Burdwan Medical College, Dr Shreevidya Venkatraman, Senior Consultant, Internal Medicine, MGM Healthcare, and Arindam Choudhuri, Business Head - Global, HealthGuard along with Vinod Kumar Gupta, Managing Director, Dollar Industries Limited. The session was all about sharing the correct information and building awareness about #DontBringTheVirusHome. The panelist shared their insights and suggestions to create awareness among the general public about personal hygiene and how to protect themselves now onwards with the new normal concept. Dollar Anti - Viral masks are priced at Rs120 for a pack of 2 pcs and the Men’s innerwear comprising of vests, briefs and trunks are priced between Rs130 to Rs190 and are available across the country. ]]> <![CDATA[Dr Reddy's launches diclofenac sodium topical gel 1% in US]]> https://biospectrumindia.com/news/95/17176/dr-reddys-launches-diclofenac-sodium-topical-gel-1-in-us.html https://biospectrumindia.com/news/95/17176/dr-reddys-launches-diclofenac-sodium-topical-gel-1-in-us.html Wed, 09 Sep 2020 12:50:00 +0530 Hyderabad based Dr Reddy’s Laboratories Ltd. (Dr Reddy’s), an integrated pharmaceutical company, committed to providing affordable and innovative medicines for healthier lives has recently announced the launch of over-the-counter Diclofenac Sodium Topical Gel 1%, the store brand version of Voltaren® Arthritis Pain in the U.S. market. Marc Kikuchi, CEO, North America Generics, Dr Reddy’s Laboratories, commented on the launch, “The launch of Dr Reddy’s Diclofenac Sodium Topical Gel, 1% (OTC), is an important addition to our Pain/ Analgesics portfolio of OTC products, and represents our continued commitment to the Private Label OTC space.” He added, “We are pleased to partner with Encube Ethicals to bring this product to market for the benefit of consumers.” Dr Reddy’s Diclofenac Sodium Topical Gel, 1% (OTC), is used for the temporary relief of arthritis pain ONLY in the following areas: Hand, wrist, elbow Foot, ankle, knee Voltaren® Arthritis Pain brand had total U.S. retail sales of approximately $44 million since launch in May 2020 according to IRI. Voltaren® is a trademark of Novartis Corporation. Dr Reddy’s Diclofenac Sodium Topical Gel, 1% (OTC), will soon be available in multiple pack sizes to allow consumers a variety of purchasing options. ]]> <![CDATA[TCS joins race for finding COVID-19 cure using AI]]> https://biospectrumindia.com/news/95/17173/tcs-joins-race-for-finding-covid-19-cure-using-ai.html https://biospectrumindia.com/news/95/17173/tcs-joins-race-for-finding-covid-19-cure-using-ai.html Wed, 09 Sep 2020 01:00:00 +0530 India, too, like the rest of the world, is part of this ongoing race to find a cure for COVID-19. A leading Indian pharma company had to undertake clinical trials for two of its drugs for COVID-19 patients. Typically, these trials would require that research associates to be present at the hospital or research facility to monitor proceedings in person and in real time.   But lockdown restrictions posed a challenge, making remote monitoring the only viable option. The pharma company was also up against a deadline to kick off trials at the earliest and looking to accelerate its timeline to test and study trial outcomes. It was technology that offered a solution.  TCS’ Advanced Drug Development (ADD) Analytics and Insights Platform furthered a digital transformation in clinical trials as it allowed the pharma team to remotely review critical parameters and key performance indices, execute data driven decisions and enable targeted operational monitoring. The pharma company was tech-enabled to manage the trials remotely using the TCSS ADD Platform setup in a record two weeks.  In a separate research endeavor at Tata Consultancy Services’ Innovation Lab in Hyderabad, a team of TCS Research and Innovation (R&I) scientists from the Life Sciences unit identified 31 molecular compounds that hold promise towards finding a cure for COVID-19. Artificial Intelligence (AI) was a key part of this discovery process.   The scientists began by focusing on de-novo drug design and the setting up of an AI model. The fundamental strength of AI is that it can rapidly evaluate multiple scenarios with a multitude of parameters while problem-solving; AI and medical research therefore make for a potent combination.   It is important to remember that the molecular universe comprises zillions of molecules, and the world of chemistry has probably looked at just about a 100 million of these. The next step in this Life Sciences R&I [SR1] research project was to ask the AI model specifically about the SARS-Coronavirus-2 (SARS-CoV-2), the virus that spawned COVID-19.   “We filtered the suggestions of the AI model to a set of 1,450 molecules, and further shortlisted 31 that could possibly be synthesized for further testing,” said Dr Gopalakrishnan Bulusu, a principal scientist involved in the exploration.   The results from the research -- put together by Dr Bulusu, Dr Arijit Roy, Dr Navneet Bung and Ms. Sowmya Krishnan -- have been published in the preprint open access chemistry archive, ‘ChemRxiv’.   The team is working closely with Council for Scientific and Industrial Research (CSIR) that agreed to provide its labs for the synthesized testing of these 31 molecular compounds. While much is still to come, for now, TCS R&I has taken its first step in the global battle against coronavirus.  ]]> <![CDATA[Bluemark Promotions’ innovative face shield draws huge response]]> https://biospectrumindia.com/news/95/17177/bluemark-promotions-innovative-face-shield-draws-huge-response.html https://biospectrumindia.com/news/95/17177/bluemark-promotions-innovative-face-shield-draws-huge-response.html Wed, 09 Sep 2020 01:00:00 +0530 As the number of Covid-19 cases rise across India, so is the demand for quality protective equipment. To cater to this growing demand for protective gear, Pune-based manufacturing company Bluemark Promotions brought together a R&D team comprising of doctors, engineers and product designers to develop an innovative product – Smartguard Face Shield under their brand Covid Comfort. Within a month of its launch, the Smartguard face shield has generated a huge response in both domestic as well as international markets. The Made in India product has become to go-to protective equipment for healthcare professionals and people moving out of their homes to resume work. “We have observed that the mass public finds it difficult and inconvenient to wear face masks since restricts comfortable breathing and also causes hindrance while talking. Face shields, though provide better protection are either too delicate or too heavy for the users to wear all day. The Smartguard provides best-in-class safety and comfort for the people and within a month of its launch we are receiving an overwhelming response from the Indian market as well as overseas. We are now working towards increasing our daily production capacity from 5,000 pcs a day to 10,000 pcs by end of this month” said Sachin Lunavat, Founder Director, Bluemark Promotions. The Smartguard weighs merely 100 grams and is designed to completely cover the users face. The shield comes with replaceable visors and filters – something no other product provides in this category and is designed to provide users a comfortable wearing experience without any fogging or voice echo. “It is really encouraging that the Smartguard has become the first choice for all health workers and the general public. We are receiving requests from distributors across India who are interested in associating with us to ensure it reaches to the mass public. Apart from the Indian market we will also be exporting this to San Francisco, Italy, Canada, UAE, Ecuador, Nairobi and other countries. The Smartguard is one of our first patented products under our brand ‘Covid Comfort’ and we have many more innovations in the pipeline focused towards pushing manufacturing of quality medical devices in India.” said Yash Lunavat, CEO, Bluemark Promotions. The Covid Comfort Smartguard face shields are available across India at all major medical stores. The company has also made them available through leading e-commerce platforms like Amazon and Flipkart. Given the growing demand for the product and the urgent need of protective products for fighting the pandemic, Bluemark Promotions has rapidly expanded its distribution network in the last month.  ]]> <![CDATA[Ipca partners with Dassault Systèmes for digital pharma experience]]> https://biospectrumindia.com/news/95/17169/ipca-partners-with-dassault-systmes-for-digital-pharma-experience.html https://biospectrumindia.com/news/95/17169/ipca-partners-with-dassault-systmes-for-digital-pharma-experience.html Wed, 09 Sep 2020 00:00:00 +0530 Dassault Systemes, headquartered in France, has announced that Ipca Laboratories Limited, a fully-integrated Indian pharmaceutical company in Mumbai, has chosen the ONE lab industry solution experience to improve overall laboratory operational excellence and support its digitalization journey. The ONE Lab industry solution experience offers research, development, analytical and manufacturing QC laboratories a unique opportunity to remove paper processes and better support end-to-end processes. It provides a standard understanding and usage of laboratory equipment, materials and procedure steps as well as a unified role-based user experience for the lab. The deployment will enable Ipca to improve processes that add value to the business, gain on-demand availability of historic data for audits, access real-time data to make decisions, ensure compliance and data integrity, and focus on quality. Today, pharmaceutical companies look for procedure execution with data and metadata capture with full instrument integration. Manual transcription from and into other IT systems is cumbersome, time-consuming and error-prone. Therefore, a platform for integration and interoperability with IT systems to support their data exchange activities and compliance is essential.  Science-based organizations need to optimize lab operations by improving efficiency, maximizing quality, complying with regulatory requirements and driving innovation. Contactless manufacturing is evolving to be the new norm and these goals can be achieved by removing paper-based and disconnected systems, which can hinder data and technology transfer between research, development and manufacturing. The ONE Lab industry solution experience works beyond traditional Laboratory Information Management System (LIMS) and Electronic Lab Notebook (ELN) products available in the market. ]]> <![CDATA[Hamdard Labs to start trials for two immunity boosting medicines]]> https://biospectrumindia.com/news/95/17165/hamdard-labs-to-start-trials-for-two-immunity-boosting-medicines.html https://biospectrumindia.com/news/95/17165/hamdard-labs-to-start-trials-for-two-immunity-boosting-medicines.html Tue, 08 Sep 2020 01:00:00 +0530 Hamdard Laboratories (Medicine Division), a progressive research-based health and wellness organization based in New Delhi, announced that it has received all the regulatory approvals to begin the proof of concept clinical trial for its Infuza and Kulzam drugs to prevent COVID-19 infection.  A research team from Hamdard Institute of Medical Sciences and Research (HIMSR) is going to start the clinical trial at HAH Centenary Hospital, New Delhi, to evaluate the efficacy of these drugs for the prevention of COVID-19 infection in high-risk subjects. The research group is working on a randomized, parallel group clinical trial for the repurposing of two popular Hamdard Medicines i.e. Infuza and Kulzum for the prevention of COVID-19 infection at HAHC hospital which conducts more than 100 COVID-19 tests per day. The Department of Microbiology at HIMSR & HAHC Hospital have a Biosafety Levels -2 (BSL-2) laboratory dedicated to RT-PCR testing for COVID-19 by CBNAAT technique. The testing process is certified by National Accreditation Board for Testing and Calibration Laboratories (NABL) and Indian Council of Medical Research (ICMR). Free antigen testing is also supported by Delhi Government at HAH Centenary Hospital. The Department is also equipped for COVID-19 serology testing.  Asad Mueed, Executive Trustee, Hamdard Laboratories India (Medicine Division) said “COVID-19 is arguably the biggest health crisis the world has faced in the 21st century. Hamdard Laboratories India (Medicine division) is working on the best of their capacity to face this pandemic. A research group of Hamdard Institute of Medical Sciences and Research (HIMSR) that comprises an Allopathic doctor, Unani Hakim, Microbiologist and Biochemist is working on a randomized, parallel group clinical trial for the repurposing of two popular Hamdard Medicines i.e. Infuza and Kulzum for the prevention of COVID-19 infection. Infuza has been used for the prevention and treatment of common cold and epidemic flu and popularly used for decades. Unani preparations that have immunomodulatory effects may be very helpful to combat against infectious diseases. Kulzum is one such preparation with chemical constituents like eucalyptol, menthol, thymol, eugenol, and l-limonene and these have anti-inflammatory, anti-microbial and most importantly immunomodulatory activities”. “We have completed the manufacturing of Infuza and Kulzum drugs as per GMP regulations and their quality is validated by using advanced techniques like HPTLC, and GC-MS” said Mr Santosh Joshi, Head, Research & Development, Hamdard Laboratories (Medicine Division). “Over the next week, we are going to start the clinical trial at HAH Centenary Hospital, New Delhi to evaluate the efficacy of these drugs for the prevention of COVID-19 infection in high risk subjects”, said Dr.  G. N. Qazi, Chief Executive Officer, Hamdard Institute of Medical Sciences and Research and associated HAH Centenary Hospital. “The study concept is approved by ‘Special Project Approval Committee’, Ministry of AYUSH and it is also cleared by Institutional Ethics Committee. The trial is registered in Clinical Trial registry of India, Indian Council of Medical Research and the registration number is CTRI/2020/08/027222” added Dr. Qazi. The clinical trials are an important part of India’s battle in fighting the novel coronavirus. In such unprecedented times, having a strong immune system is the ideal preventive measure while individuals practice social distancing. Hamdard products are developed with natural formulations that combine the benefits of time-tested herbs for strengthening overall immunity, which may be helpful in minimizing the impact of the COVID-19 virus through the development of specific antibodies. Effective adjunct therapy will push up innate immune capability and facilitate the development of specific antibodies to fight against coronavirus infections.   ]]> <![CDATA[Cadila Pharma unveils Obeticholic acid tablets in India]]> https://biospectrumindia.com/news/95/17162/cadila-pharma-unveils-obeticholic-acid-tablets-in-india.html https://biospectrumindia.com/news/95/17162/cadila-pharma-unveils-obeticholic-acid-tablets-in-india.html Mon, 07 Sep 2020 17:10:00 +0530 Ahmedabad based Cadila Pharmaceuticals has launched Obetocad in India, a generic version of Ocaliva® (Obeticholic Acid) primarily used for the treatment of Primary Biliary Cholangitis (PBC). For the treatment of PBC, currently, Ursodeoxycholic acid (UDCA) is being extensively used. Around 40% of the patients do not respond to UDCA treatment and 5-10% of patients observe severe side effects. Obetocad can be used as a monotherapy or along with UDCA for the treatment of patients who are unresponsive to UDCA therapy. Obetocad is available in 5 mg and 10 mg tablets in packs of 10 tablets. It is also USFDA and EMA approved and recently received its DCGI approvals. Obetocad also has the potential to be used in other indications such as NASH, NAFLD, severe acute hepatitis, bile acid diarrhea, bariatric and gallstone diseases. Cadila Pharmaceuticals has always been focused on making sure high quality, affordable, and life-saving treatments are within the reach of patients. Cadila Pharma has also recently launched 4 biosimilar products in the past 2 months under the brand name Bevaro™, Ritucad™, Cadalimab™, and NuPTH for the treatment of cancer and osteoporosis. Cadila plans to launch multiple biosimilar products this year for the Indian Market. Cadila, one of the largest privately-held pharmaceutical companies in India, has recently concluded and cleared USFDA inspection successfully in February 2020. Over the past six decades, Cadila Pharmaceuticals has been engaged in the development and manufacturing of affordable medicines and in making them available for patients across the world. Its innovation-driven drug discovery processes ensure the health and well-being of people around the world.   ]]> <![CDATA[GARDP partners with Bugworks to tackle serious bacterial infections]]> https://biospectrumindia.com/news/95/17153/gardp-partners-with-bugworks-to-tackle-serious-bacterial-infections.html https://biospectrumindia.com/news/95/17153/gardp-partners-with-bugworks-to-tackle-serious-bacterial-infections.html Fri, 04 Sep 2020 00:00:00 +0530 The Global Antibiotic Research and Development Partnership (GARDP) has announced a collaboration with Bugworks Research Inc (Bugworks), an Indian-USA-Australian biopharmaceutical group developing new treatments for antibiotic-resistant infections. GARDP and Bugworks have signed a Memorandum of Understanding (MOU) which puts in place a framework to enable Bugworks and GARDP to work together with the objectives of maximizing the resources and impact of both organizations to accelerate the development and availability of lifesaving treatments. This includes working together for the preparation of regulatory strategies, in particular for clinical development programmes and post-approval studies. “This Memorandum of Understanding with Bugworks recognizes the significant role of India in pharmaceutical research and development,” said Jean-Pierre Paccaud, GARDP Director of Business Development and Corporate Strategy. “It is an important opportunity to explore synergies in the development of urgently needed treatments for drug-resistant infections.” “Bugworks has the dual advantage of doing research and development in India, which has a high burden of drug-resistant infections, while still being able to work with the best research organizations all over the world,” said Dr Santanu Datta, Bugworks co-founder and Chief Scientific Officer. “Through our collaboration with GARDP, we are uniquely positioned to spearhead novel antibiotic development that serves the Indian subcontinent, the ASEAN group of countries, in addition to the EU and Americas. Importantly, our collaboration with GARDP is focused on the development of antibiotics addressing unmet needs, including for paediatric and neonatal populations.” ]]> <![CDATA[Roche Diabetes Care enters into strategic alliance with Indian partners]]> https://biospectrumindia.com/news/95/17141/roche-diabetes-care-enters-into-strategic-alliance-with-indian-partners.html https://biospectrumindia.com/news/95/17141/roche-diabetes-care-enters-into-strategic-alliance-with-indian-partners.html Thu, 03 Sep 2020 00:00:00 +0530 Roche Diabetes Care (RDC) India recently entered into strategic alliance with Indian partners to fulfil its commitment of providing true relief to persons with diabetes (PwD) through integrated Personalised Diabetes Management (iPDM) solutions. These are part of the company’s public-private-partnership model to create a holistic eco-system of care for PwDs by joining hands with like-minded partners. The company has partnered with emerging Indian business such as Phable, Wellthy Therapeutics and PharmEasy to bolster its outreach to the PwDs. Through its partnership with Phable, women with GDM using Accu-Chek meters will now have access to a healthcare practitioner (HCP) to monitor their diabetes closely and make necessary therapy titrations via the PhableCare app. This helps improve clinical outcomes and leads to deliveries with fewer complications. Renewing its existing partnership with Wellthy Therapeutics, the company is now offering its Accu-Chek Active users remote access to personalized coaching from highly skilled diabetes educators, round-the-clock support based on individual needs, and implementation of goal-and-condition based diabetes management plans to improve self-care behaviors for better health outcomes. Through the partnership with PharmEasy, RDC India has enhanced customer service by addressing key customer pain points. The new start up ecosystem has brought in process agility, thereby creating customer delight. To strengthen and optimize its distribution channels, the company has partnered with Udaan, a B2B e-commerce platform that enables retailers and businesses to source merchandise from manufacturers, brands, white labels, importers, etc. across the country, on a single platform. The tech-enabled national distribution model of Udaan will help RDC India bring agility and transparency in managing their primary and secondary distribution.  The model will be implemented throughout the country in a phased out manner.  Earlier this week Roche Diabetes Care India inaugurated the kit assembly site with Parekh Integrated Services Pvt. Ltd. (PISPL). This new kit assembly site is best in class facility compliant with Roche Global Quality & Safety standards and will assemble and pack blood glucose monitoring kits to fulfill India sales demand. As a strategic partner, PISPL will provide quality manpower and management system for the site.  Speaking about the developments, Omar Sherief Mohammad, Country Head, Roche Diabetes Care India, said, “At Roche we are committed to provide Persons with Diabetes (PwD) comprehensive diabetes management through innovative Integrated Personalised Diabetes Management(iPDM) solutions. In this journey we have chosen to partner with like-minded Indian companies who are doing path-breaking work to create innovative platforms that enable optimal personalised diabetes management and improve therapy outcomes. I am confident that together we can bring true relief to PwDs so that they can spend more time in range.” ]]> <![CDATA[Lupin launches US FDA approved leflunomide tablets USP]]> https://biospectrumindia.com/news/95/17137/lupin-launches-us-fda-approved-leflunomide-tablets-usp.html https://biospectrumindia.com/news/95/17137/lupin-launches-us-fda-approved-leflunomide-tablets-usp.html Wed, 02 Sep 2020 17:05:00 +0530 Lupin Limited (Lupin), an innovation-led transnational pharmaceutical company headquartered in Mumbai has recently announced the launch of leflunomide tablets USP, 10 mg and 20 mg. Having received approval from the United States Food and Drug Administration (U.S FDA) earlier, the product would be manufactured at Lupin’s Pithampur (Unit I) facility in India. Leflunomide Tablets USP, 10 mg, and 20 mg, is the generic equivalent of Arava® Tablets, 10 mg, and 20 mg, of Sanofi-Aventis U.S LLC., and is indicated for the treatment of adults with active rheumatoid arthritis (RA). Leflunomide Tablets USP (RLD: Arava®) had an annual sale of approximately USD 42 million in the U.S. (IQVIA MAT June 2020).   ]]> <![CDATA[CSM Technologies brings COVID-19 vaccine tracker]]> https://biospectrumindia.com/news/95/17135/csm-technologies-brings-covid-19-vaccine-tracker.html https://biospectrumindia.com/news/95/17135/csm-technologies-brings-covid-19-vaccine-tracker.html Wed, 02 Sep 2020 00:00:00 +0530 As the global quest continues for an effective panacea to forestall the spread of the CoVID-19 pandemic, GovTech pioneer CSM Technologies in Bhubaneshwar has designed and developed "CoVaTrack"- the first India focused Covid-19 vaccine & treatment tracker. Under its Corporate Social Responsibility programme, CSM has tried to bring some respite to the most concerned subject of today. CoVID-19 vaccine is one of the most searched topic in the Internet as people are sifting through volumes of information to find out about the latest developments in this space. CoVaTrack is a one stop destination to get information about the vaccine development, as pharma companies, researchers and nations from across the world are working at a feverish pace to stop coronavirus in its track, which has caused enormous havoc and distress world over. In the long-drawn process of vaccine development, CoVaTrack will keep a close track of the vaccine development efforts through multiple stages of clinical trials before regulatory approval and commercial release to market. Phase wise clinical trials are used to gauge the efficacy, dosage and side effects of either a vaccine that closely emulates the behaviour of the virus to generate antibodies or an existing drug repurposed for treating coronavirus, and similar other treatments. The tracker aims to provide every such information about the developers and researchers of ongoing trials that can encourage others in the similar lines and the development authorities to partner, invest and fast track such efforts. The tracker aggregates publicly available information from global clinical trials registries & other credible sources. Rich visualizations in a mobile first User Interface make the tracker interactive and user friendly. This tracker of Vaccines & Treatments also looks forward to provide insights in the area of researches and novel methodologies used or invented to further the process. It will inform about the promising efforts being made to find a lasting cure and instil hope & confidence in a safer tomorrow. ]]> <![CDATA[Globus Infocom launches disinfectant ULV fogger to tackle spread of viruses]]> https://biospectrumindia.com/news/95/17131/globus-infocom-launches-disinfectant-ulv-fogger-to-tackle-spread-of-viruses.html https://biospectrumindia.com/news/95/17131/globus-infocom-launches-disinfectant-ulv-fogger-to-tackle-spread-of-viruses.html Tue, 01 Sep 2020 17:15:00 +0530 Make in India brand Globus Infocom, one of the most innovatory firms with a key focus on providing highly advanced & reliable technological solutions to education technology has now forayed into the healthcare and wellness industry to craft an efficient and professional range of solutions to prevent the spread of any infectious disease and evidence management of suspected cases. The company has recently launched its new product disinfectant ULV cold fogger, which has been proven highly effective in curtailing the scope of infection by application of sanitizer and disinfectant liquid in high-touch areas preventing cross-contamination. It generates a fog or mist formed by Ultra Low Volume (ULV) droplets that remain in the air for several minutes after application. Studies have substantiated that droplets of smaller size are ideal for disinfecting and eliminating pathogens like Coronavirus from the surfaces. These droplets are capable of reaching the most inaccessible parts where conventional cleaning can’t reach. Unlike many other foggers available in the market, Globus ULV disinfectant is a cold fogger that uses 70 per cent alcohol-based sanitizer which is highly effective in managing virus contaminations. Globus disinfectant ULV foggers can also effectively reach a much larger area in a shorter time that helps to break the chain of infection efficiently. It has a wide spray range of 8-10 meters (in static wind) with a spraying rate of 150-260 ml/min.   ]]> <![CDATA[AZ reveals benefits of diabetes medicine on patients with CKD]]> https://biospectrumindia.com/news/95/17123/az-reveals-benefits-of-diabetes-medicine-on-patients-with-ckd.html https://biospectrumindia.com/news/95/17123/az-reveals-benefits-of-diabetes-medicine-on-patients-with-ckd.html Tue, 01 Sep 2020 00:00:00 +0530 AstraZeneca India (AstraZeneca Pharma India Limited) recently announced the full results from the clinical trials of its latest diabetes drug, dapagliflozin, showing significant benefits in reducing chronic kidney disease (CKD) progression in patients with and without type-2 diabetes. The DAPA-CKD study concluded globally on 30th March 2020 based on its effectiveness and safety.  Global disease burden report of 2015 pointed out that CKD is the 12th most common cause of death with a 37.1% rise in mortality over 10 years. The prevalence of CKD in India is estimated to be 17.2%, given its population >1 billion, the rising incidence of CKD is likely to pose major problems for both healthcare and the economy in future years.  Detailed results from the ground-breaking Phase III DAPA-CKD trial showed that AstraZeneca’s Dapagliflozin on top of standard of care reduced the composite measure of worsening of renal function or risk of cardiovascular (CV) or renal death by 39% compared to placebo (p<0.0001) in patients with CKD Stages 2-4 and elevated urinary albumin excretion. The results were consistent in patients both with and without type-2 diabetes (T2D). The primary composite endpoint was ≥50% sustained decline in estimated glomerular filtration rate (eGFR), the onset of end-stage kidney disease (ESKD) and CV or renal death. The absolute risk reduction (ARR) was 5.3% over the median time in study of 2.4 years. DAPA-CKD is the first trial to demonstrate efficacy, including improvement on survival, in CKD patients both with and without Type2 Diabetes.  ]]> <![CDATA[Biocon, Mylan launch Semglee in US to expand access for diabetic patients]]> https://biospectrumindia.com/news/95/17124/biocon-mylan-launch-semglee-in-us-to-expand-access-for-diabetic-patients.html https://biospectrumindia.com/news/95/17124/biocon-mylan-launch-semglee-in-us-to-expand-access-for-diabetic-patients.html Tue, 01 Sep 2020 00:00:00 +0530 Biocon Biologics India Ltd., a fully integrated biosimilars company and a subsidiary of Biocon Ltd. (BIOCON), and Mylan N V (MYL), recently announced the U.S. launch of Semglee™ (insulin glargine injection) in a vial and pre-filled pen presentations, approved to help control high blood sugar in adult and pediatric patients with type 1 diabetes and adults with type 2 diabetes. It is not recommended for the treatment of diabetic ketoacidosis. Semglee, which received final approval from the U.S. Food and Drug Administration (FDA), has an identical amino acid sequence to Sanofi’s Lantus® and is approved for the same indications. To encourage broad patient access to this important medicine, Mylan is offering Semglee at a wholesale acquisition cost (WAC) of $147.98 per package of five (5) 3ml pens and $98.65 per 10ml vial, representing the lowest WAC for any long-acting insulin glargine on the market. The list price of Semglee pen is equivalent to the Lantus launch price in 2007, and the Semglee vial is listed at Lantus’s 2010 pricing. Eligible patients may also qualify for patient assistance and/or a co-pay card, similar to other medications in this class. Additionally, Mylan has submitted to FDA all necessary documentation to request approval of Semglee as a biosimilar to Lantus under the 351(k) pathway and remains confident in seeking an interchangeability designation. ]]> <![CDATA[Biogetica receives US patent for ayurvedic research on herpes]]> https://biospectrumindia.com/news/95/17119/biogetica-receives-us-patent-for-ayurvedic-research-on-herpes.html https://biospectrumindia.com/news/95/17119/biogetica-receives-us-patent-for-ayurvedic-research-on-herpes.html Mon, 31 Aug 2020 00:00:00 +0530 Mumbai based Biogetica, has announced its groundbreaking trials result on Hherpe The research successfully marks reduced time & early treatment with the use of combination therapy of the company’s Hyperisince and Reginmune. The Ayurvedic remedy has been granted a patent by the US patent office. In 2004, Dr. T Vijayan from the JSS School of pharmaceuticals discovered that extracts of Hypericum Mysorense, a rare plant from the Nilgiri Hills could completely suppress the herpes virus in-vitro. Hyperisince has since been licensed by AYUSH for the management of herpes and is slowly but surely gaining popularity amongst both Doctors and Patients looking for a safe and effective way of dealing with this pest of a virus variants of which are called herpes simplex and herpes zoster. Speaking on the development, Dr. Vijay Kamat, Medical Director, Biogetica, said, “It is amazing to see how nature in its original perfection can outperform and complement synthetic molecules as medicine. This is a reality that both Doctors and Patients are waking up to globally. The old paradigm of patenting and mimicking molecules for profit is going away as the perfection of life cannot be recreated in a lab.  We are forever grateful to Doctors across the planet that have helped us reach this point and those that realize that their Hippocratic oath is made to patient healing and not a particular medicine system.” He further added that “We are successful, as each study we have conducted has shown groundbreaking results. We are failures as products such as hyperisince still yet do not sell even 1/10 of the pharmaceutical they outperformed in the studies. We keep going because each day we wake up to a letter of thanks from someone somewhere!” Clinical trials published in 2017 showed remarkable results for Herpes, busting the age-old myth that Ayurveda takes a longer time to show results and that someone with herpes will always have recurrences.  In the trial, it was seen that a herpes outbreak usually lasts 21 days without treatment. Acyclovir the FDA approved pharmaceutical for herpes can bring that duration down to 9 days. The combination therapy of Hyperisince and Reginmune however brought the average time down to 3 days.  Furthermore, 76% of patients with genital herpes who took the combination of Hyperisince and Reginmune did not have a relapse of herpes for the follow-up period of 2 years.   ]]> <![CDATA[Intas Pharma develops hyperimmune globulin for COVID-19 treatment]]> https://biospectrumindia.com/news/95/17120/intas-pharma-develops-hyperimmune-globulin-for-covid-19-treatment.html https://biospectrumindia.com/news/95/17120/intas-pharma-develops-hyperimmune-globulin-for-covid-19-treatment.html Mon, 31 Aug 2020 00:00:00 +0530 The R&D team at Ahmedabad based Intas Pharma has developed COVID-19 specific Hyperimmune Globulin as treatment for patients suffering from moderate to severe COVID-19 infection. Hyperimmune Globulin also has potential for use as prophylaxis for all high-risk population in contact with COVID-19 patients. This could be an important therapeutic option that can potentially help combat the disease until a vaccine is available. Intas is among the world's first to adopt this approach for treating COVID-19 patients.  This will be a Corporate Social Responsibility (CSR) initiative from Intas in collaboration with all Indian Blood Banks, that will help to procure convalescent plasma (plasma extracted from patients recovered from COVID-19 infection). Intas has received permission from the Drug Controller General of India (DCGI), to conduct clinical trial by using the newly developed COVID-19 specific Hyperimmune Globulin. After establishing its usefulness in the clinical trial, this product will be available for use in treating COVID-19 patients.  Commenting on the development, Dr Alok Chaturvedi, Head of Medical & Regulatory Affairs, Intas, mentioned that "This endeavour is a testament to Intas' commitment towards meeting unmet medical need of the society through research driven solutions." Intas is establishing an alliance with medical and research institutions, blood donation groups to collect the plasma from recovered COVID-19 patients. Intas will shortly launch a website to help recovered COVID-19 patients to locate the nearest Blood Bank where they can safely donate plasma. The company seeks government support to facilitate the supply of convalescent plasma for the manufacturing of these enriched Hyperimmune Globulin and thereby help more patients conquer COVID-19. ]]> <![CDATA[Sirona launches ayurvedic hydrogel-based pain relief patch]]> https://biospectrumindia.com/news/95/17110/sirona-launches-ayurvedic-hydrogel-based-pain-relief-patch.html https://biospectrumindia.com/news/95/17110/sirona-launches-ayurvedic-hydrogel-based-pain-relief-patch.html Fri, 28 Aug 2020 00:00:00 +0530 To solve feminine intimate and menstrual hygiene issues, Delhi based Sirona has launched a pain relief patch, this time for teens. It is 100% ayurvedic, hydrogel-based and offers an efficient and convenient solution for teens suffering from period pain. Sirona beginner’s hydrogel-based pain relief patch has the goodness of menthol, which eases cramps and muscle pain for up to 8 hours. The hydrogel layer on it adds to the cooling effect, is soft on the tender skin of teenagers and makes it easy to apply and remove after use.  Being chemical-free and ultra-thin, it sticks on the abdomen/ leg/ back discreetly under one’s clothes, easing pain without any side effects. Teenagers are now free of popping harmful painkillers and using impractical hot water bottles on their painful period days. They can apply the pain relief patch while traveling, in school, or at home, without disturbing their study or play routine and even mental peace.  ]]> <![CDATA[Premas Biotech planning to initiate COVID-19 vaccine trials]]> https://biospectrumindia.com/news/95/17113/premas-biotech-planning-to-initiate-covid-19-vaccine-trials.html https://biospectrumindia.com/news/95/17113/premas-biotech-planning-to-initiate-covid-19-vaccine-trials.html Fri, 28 Aug 2020 00:00:00 +0530 Gurugram based Premas Biotech has said that its triple-antigen vaccine candidate for COVID-19 has induced neutralizing immune response in mice during the four-week test of its SARS-CoV-2 vaccine candidate. The company is in talks with the regulatory authorities concerned to plan and initiate next steps towards conducting human trials. The study consisted of 50 mice, divided into 10 cohorts dosed with 5, 10 and 20 micrograms of PRAK-03202 vaccine candidate. The vaccine candidate was generally well tolerated and safe at all doses, with no adverse events reported. The vaccine candidate was safe even at higher doses and generated a robust immune response against all three SARS-Cov2 antigens, Spike (S), Envelope (E) and Membrane (M). PRAK-03202 elicited neutralizing antibody titers levels in all doses, from 5 microgram to 20 microgram dose regimens. After three doses in mice, all groups cohorts showed binding antibody levels similar to convalescent patients’ levels.  Prabuddha Kundu, Co-Founder and Managing Director at Premas Biotech, commented: “We are happy to report that the vaccine candidate study in mice has gone on well, and the results are positive and encouraging. We have engaged with the regulatory authorities in India and are working towards the next steps under their guidance.” Premas’ vaccine candidate is triple-antigen (based on the three COVID-19 proteins S, M & E) which differentiates it from other candidates under development around the world. Earlier in May, Premas Biotech had announced that it was the first in the world to obtain transmission electronic microscopic (TEM) images of the recombinant virus like particle (VLP) of SARS-CoV-2 virus. Dr Nupur Mehrotra, Co-founder & COO at Premas Biotech, said “Premas will seek to further characterize the immune response in the near term, while pursuing additional safety studies and later stage animal testing with the goal of an investigational new drug (IND) submission to follow.” ]]> <![CDATA[Cadila Pharma unveils arthritis biosimilar drug ]]> https://biospectrumindia.com/news/95/17116/cadila-pharma-unveils-arthritis-biosimilar-drug-.html https://biospectrumindia.com/news/95/17116/cadila-pharma-unveils-arthritis-biosimilar-drug-.html Fri, 28 Aug 2020 00:00:00 +0530 Ahmedabad based Cadila Pharmaceuticals has recently announced the launch of Adalimumab biosimilar under the brand name Cadalimab™ for the domestic market. Adalimumab is a disease-modifying antirheumatic drug and a monoclonal antibody that works by inactivating tumor necrosis factor-alpha (TNFα) recommended in the treatment of many diseases. Adalimumab, popular under the brand name Humira® by Abbvie is used to treat rheumatoid arthritis, psoriatic arthritis, Ankylosing Spondylitis and psoriasis. In an effort to strengthen their the biosimilar product portfolio, Cadalimab™ is the fourth biosimilar launched in the last 2 months by Cadila Pharmaceuticals. “Around 7 million* people in India suffer from rheumatoid arthritis, while 0.44-2.8%** of people in India suffer from Psoriasis. While these are not life-threatening, Psoriasis and RA can be painful to live with. With the launch of Cadalimab™, we want to reach these patients with a cost-effective solution and give them a chance at a better life.” shared Amit Ajmera, Vice President, Cadila Pharmaceuticals Limited. “With the launch of every product, we strengthen our core philosophy of providing quality medicines to all. Cadalimab™ comes in an easy pre-filled syringe which makes it easy to use for every patient and provides them relief from disorders such as arthritis and Psoriasis. We are on a journey to expand treatment options with affordable biosimilars”, said Mr. O.P. Singh, President -Sales and Marketing, Cadila Pharmaceuticals Limited. Cadalimab™ is available in 40mg/0.8ml injection and has shown to have significant reduction in signs and symptoms of Rheumatoid Arthritis, Juvenile Idiopathic Arthritis, Ankylosing Spondylitis, Psoriatic Arthritis and Psoriasis after the usage of Cadalimab™. Cadila Pharmaceuticals recently launched 3 more biosimilar products in the last 2 months under the name Bevaro™, Ritucad™ and NuPTH for treatment of cancer and osteoporosis. The pharma giant has always been focused on making sure high quality, affordable and life-saving treatments are within the reach of patients. Cadila plans to launch multiple biosimilar products this year for the Indian Market. ]]> <![CDATA[TUV Rheinland offers testing services of protective face masks in India]]> https://biospectrumindia.com/news/95/17108/tuv-rheinland-offers-testing-services-of-protective-face-masks-in-india.html https://biospectrumindia.com/news/95/17108/tuv-rheinland-offers-testing-services-of-protective-face-masks-in-india.html Thu, 27 Aug 2020 12:40:00 +0530 Bengaluru based TUV Rheinland, an international independent third-party testing, inspection, and certification service provider has announced the launch of testing services for protective face masks and medical coveralls that comply with national and international standards including Indian standards such as IS 16289 for surgical masks, EN 14683 and ASTM F2100. TUV Rhineland's state-of-the-art laboratory ensures the safety and quality of protective face masks remain uncompromised. Thomas Fuhrmann, Managing Director, TUV Rheinland India said, "Face masks play an important role in pandemic control. During the ongoing COVID-19 outbreak, the efficacy and quality of face masks has been a public awareness concern. Protecting people from COVID-19 is the utmost priority for businesses, organizations, and governments. Our testing and certification services verify the product's effectiveness as well as compliance with regulatory norms in the destination market." He added, "By providing nationally and internationally recognized tests and certifications, we offer an extensive range of services and comprehensive test reports. Our customers benefit from short test times, and speedier access to domestic and international markets. TUV Rheinland will continue to pay close attention to the fast-evolving pandemic situation, while fully cooperating with the government as well as relevant medical bodies and customers to strictly control the quality of personal protective equipment." ]]> <![CDATA[Piramal Pharma partners with Epirium Bio for orphan drugs]]> https://biospectrumindia.com/news/95/17106/piramal-pharma-partners-with-epirium-bio-for-orphan-drugs.html https://biospectrumindia.com/news/95/17106/piramal-pharma-partners-with-epirium-bio-for-orphan-drugs.html Thu, 27 Aug 2020 00:00:00 +0530 Mumbai based Piramal Pharma Solutions, a leading contract development and manufacturing organization (CDMO), has announced that the company will be partnering with US based Epirium Bio on an exclusive manufacturing relationship for new orphan drugs targeting rare diseases with high unmet needs. The Piramal Pharma Solutions (PPS) team is providing Epirium with an integrated program that encompasses formulation development, supply of APIs and intermediates, chemistry development and manufacturing, and solid oral dosage form drug product. The work is being completed across three PPS sites in India, with the seamless alignment of information, technology, and project management that will speed timelines and bring the drugs to market faster. According to Peter DeYoung, Chief Executive Officer, Piramal Pharma Solutions, “This program with Epirium exemplifies the ways we lead the market in delivering integrated services. We’ve back-integrated our supply of intermediates to ensure supply chain security and quality, we’ve invested more than $1 million to add a dedicated area to our plant with the specialized technologies required to produce Epirium’s product, and we’ve developed a fully integrated process that utilizes the expertise of our teams at three sites.” Dr. Sundeep Dugar, Chief Technology Officer for Epirium, added that “Our scientific insights have led to the discovery of a novel pharmacological approach for the treatment of diseases characterized by mitochondrial depletion and dysfunction. Proof of concept has been established in early human studies and we intend to advance our clinical candidate as a potential treatment for certain relevant rare diseases with high unmet need. We expect our partnership with PPS to expedite these efforts and help us bring high-quality orphan drugs to market.” The first cycle of drug substance to drug product has been successfully completed through the integrated program. Additional cycles are in progress, as are further evolutions that will benefit future indications and new clinical programs. ]]> <![CDATA[Lupin & Mylan launch arthritis drug in Germany ]]> https://biospectrumindia.com/news/95/17102/lupin-mylan-launch-arthritis-drug-in-germany-.html https://biospectrumindia.com/news/95/17102/lupin-mylan-launch-arthritis-drug-in-germany-.html Wed, 26 Aug 2020 00:00:00 +0530 Mumbai based Lupin Limited (Lupin) and Mylan N.V. in the US have announced the launch of Nepexto® , biosimilar etanercept, in the German market. Nepexto® is indicated for the treatment of moderate to severe active rheumatoid arthritis, juvenile idiopathic arthritis from the age of 2 years, active and progressive psoriatic arthritis, severe axial spondyloarthritis, moderate to severe plaque psoriasis and chronic severe plaque psoriasis in children and adolescents from the age of 6 years. Nepexto® is approved for all therapeutic indications of the reference product Enbrel® . The Tumor Necrosis Factor (TNF) inhibitor etanercept was first approved for the treatment of rheumatoid arthritis in Germany in 2000 and since then has offered an effective treatment option for several chronic inflammatory diseases. Nepexto® is available as a solution for injection in a pre-filled pen and pre-filled syringe . Data show a high patient acceptance of the easy-to-handle pre-filled pen. Patients favored this latex-free device for selfinjection, which can lead to improvement in compliance. Nepexto® , with an equivalent efficacy and safety to reference product Enbrel®, is an attractive cost-effective treatment alternative that can contribute to sustainable healthcare and treatment options. Nepexto is the second immunology product to be introduced into the German market. In addition to Hulio®, an adalimumab biosimilar, Nepexto® expands Mylan’s therapeutic portfolio for the effective treatment of various immune-mediated diseases including rheumatoid arthritis. ]]> <![CDATA[West begins warehousing operations in Chennai]]> https://biospectrumindia.com/news/95/17096/west-begins-warehousing-operations-in-chennai.html https://biospectrumindia.com/news/95/17096/west-begins-warehousing-operations-in-chennai.html Tue, 25 Aug 2020 17:30:00 +0530 West Pharmaceutical Services Inc. (WST), a global leader in innovative solutions for injectable drug administration, recently announced the official opening of its warehousing operations in Chennai, India. The warehouse in Sriperumbudur Chennai will serve customers within the Indian market and is integral to West's ongoing efforts to enhance the customer experience through shorter lead time and improved trading process. Alagu Subramaniam, Managing Director, West Pharmaceutical Services, India said, “Our pharmaceutical customers value speed and efficiency to facilitate their work developing solutions for patients. With the opening of our warehouse in Chennai, the delivery time will be reduced to one week for the most ordered SKUs in India. Previously, depending on the SKU and the region from which it was being ordered, delivery could take anywhere from five to 16 weeks. There will be significant time saved for our customers with the new warehouse, which will make it even easier for them to do business with West.” The warehouse is expected to reduce lead time for SKU deliveries significantly for existing and potential customers. To determine the SKUs with which to begin operations, the West India team has evaluated more than 500 SKUs being ordered from different geographies, such as Singapore, the United States, and the European Union. The warehouse will initially stock a small number of the top SKUs being ordered by customers from these regions and will expand to offer more SKUs by the end of 2020.   ]]> <![CDATA[RJ Group brings UVC lighting technology for disinfection]]> https://biospectrumindia.com/news/95/17095/rj-group-brings-uvc-lighting-technology-for-disinfection.html https://biospectrumindia.com/news/95/17095/rj-group-brings-uvc-lighting-technology-for-disinfection.html Tue, 25 Aug 2020 12:55:00 +0530 Mumbai based RJ Group of Companies, a pioneer in the hospitality and healthcare sector has introduced a wide product range with UV-C disinfection system, which has been validated to effectively inactivate SARS-CoV-2, the virus that causes COVID-19. The company has taken a fresh approach by offering products that are designed with UV-C light sterilization technology. The product is specially curated for healthcare facilities. RJ Group has ensured strict quality control on every single product. All its products are 100% designed from the homegrown tested technology with ISO certification to manufacture UVC systems and the testing report generated from Haffkine Institute. Made in India this new product is another step in the company’s support to the government’s call for ‘Aatmanirbhar’.  The UV-C technology in this is designed in accordance with the norms suggested by medical and research bodies to disinfect surfaces from germicidal bacteria.  UVC disinfection is often used with other technologies in a multibarrier approach to ensure that whatever pathogen is not killed by one method is inactivated by another (UVC). UVC could be installed now in clinical or other settings to augment existing processes or to shore up existing protocols where these are exhausted by excessive demands due to the pandemic. These devices actively reduce the bacterial and viral charge of the air in closed environments. This innovative design can provide fast sterilization for hospitals and clinics by illuminating the pathogens from air and surfaces around/in rooms and personal protective equipment. ]]> <![CDATA[FDC introduces two variants of favipiravir drug]]> https://biospectrumindia.com/news/95/17097/fdc-introduces-two-variants-of-favipiravir-drug.html https://biospectrumindia.com/news/95/17097/fdc-introduces-two-variants-of-favipiravir-drug.html Tue, 25 Aug 2020 00:00:00 +0530 Mumbai based pharma major, FDC Limited has announced its foray in the fight against COVID-19 by launching two variants of the COVID-19 drug, Favipiravir – PiFLU and Favenza – which will be used to treat mild to moderate cases of COVID-19 in India. With the third largest number of cases globally, at close to three million, and a daily increase rate that is on the rise, the Indian economy and populace have both seen major hits over the past two quarters. Earlier this year, the Drug Controller General of India (DCGI) approved the use of Favipiravir, an off patent, oral anti-viral drug that has been shown to quicken clinical recovery in COVID-19 patients with mild to moderate symptoms. It is a broad spectrum anti-viral agent, and selectively inhibits RNA polymerase of influenza and SARCOV-2 virus and prevents viral replication. Commenting on the development, Spokesperson of FDC Limited, Mayank Tikkha said, “With over 2.7 million cases of COVID-19, now is the time to provide healthcare warriors in our country with viable affordable options to fight the battle against this disease. Early diagnosis and treatment will help in arresting the deteriorating condition of patients, and we will be working with the government and healthcare fraternity to make Favenza and Piflu available across the country”. FDC’s PiFLU and Favenza is currently available across the country. FDC has also increased the production and availability of its brand of balanced electrolyte drink ‘Enerzal and Electral’ as according to ASPEN guidelines, 03 litres of fluid intake in a day (60 to 120 ml in every 30 min) helps in speedy recovery of people who are home quarantined.   ]]> <![CDATA[AIOCD appeals to chemists to boycott online purchases]]> https://biospectrumindia.com/news/95/17089/aiocd-appeals-to-chemists-to-boycott-online-purchases.html https://biospectrumindia.com/news/95/17089/aiocd-appeals-to-chemists-to-boycott-online-purchases.html Mon, 24 Aug 2020 00:00:00 +0530 All India Organisation of Chemists and Druggists (AIOCD) has appealed to all chemists to boycott online purchases. According to the AIOCD, Amazon and Reliance are now ready to fight with each other and have started the illegal business of e-pharmacies and to compete & kill medicine dealers & pharmacists with their cut-throat competition. The appeal mentions that Amazon has announced the start of illegal e-pharmacy from Bengaluru which is still not allows under laws. Reliance who wishes to become number one in the world, has also expressed their eagerness by purchasing the e-pharmacy which is doing illegal activity. In the recent past, this company has shown their art of monopoly by eliminating everyone in telecommunication sector also. "The medicine dealers / Pharmacists / Chemists of our country are taking care of their business by their own capital, following the drug act, pharmacy laws and other laws of the country. Our 8.50 lakh chemists and pharmacists are feeding 50 lakh members of their family and about 50 lakh employees , and 2.50 crore of their family members. We have proved our commitment to the people of our country as ‘Custodian of Health‘ and as protector of public health in the past and during this pandemic also", said J S Shinde, President, AIOCD. "Like other Corona Warriors, we also requested government to give insurance or give Corona insurance at the government fixed rate, but it was not even heard but still all 8.50 lakh chemists of the country are fulfilling their responsibilities for the people. We did not get distracted by the role of health care, but today it is time to save our livelihood. We indirectly are also promoting online and if we, and all the bricks and mortar / or offline retailers / small shopkeepers and millions of their families and our staff boycott online purchases ourselves, then we together can teach them a lesson", he added.     ]]> <![CDATA[VEVRA launches hospital pods to fight COVID-19]]> https://biospectrumindia.com/news/95/17078/vevra-launches-hospital-pods-to-fight-covid-19.html https://biospectrumindia.com/news/95/17078/vevra-launches-hospital-pods-to-fight-covid-19.html Fri, 21 Aug 2020 13:10:00 +0530 Bengaluru based VEVRA has allied with a Portugal based Healthcare IoT company InnoWave Group to introduce the Vevra Pods. Theses pods were launched recently to jointly fight the pandemic and other contagious and airborne diseases  The project consists of a set of movable capsules that aim to efficiently assist in the infrastructure of local/private/government hospitals across India. These Pods come with advanced IoT solutions at the heart of its operation on ViGIE+ platform by InnoWave. The Vevra pods come in five variants; General pod, ICU pod, Doctors stay pod, Operation theatre pod, and Scanning room pod. Features of Vevra Pods: These pods come with an antechamber airlock room to provide a safe area for healthcare professionals for donning and doffing. It also controls the quantity and quality of the air being circulated in and out of the room. The pod comes with PLC integrated air conditioning system to help in maintaining the temperature. The pod comes with a fire resistance structure and an anti-bacterial wall and bacterial and chemical resistance flooring. ICU pod comes with a provision for Oxygen supply, analyzer as per ICU guidelines.  RO water purifier, geyser in the shower area, 500Litre water storage tank along with mobile sewage treatment plant. Fire alarm, extinguisher, and emergency system with a safe evacuation plan. Re-usable after pandemic with 15 to 20 years’ structural warranty. Can be moved to any remote location in the world. Sufficient UPS power backup with earthing connection to each pod and I-3 processor Laptop loaded with AI, RFID, and MS office.   ]]> <![CDATA[Akron Healthcare unveils disinfectant tablets to fight COVID-19]]> https://biospectrumindia.com/news/95/17061/akron-healthcare-unveils-disinfectant-tablets-to-fight-covid-19.html https://biospectrumindia.com/news/95/17061/akron-healthcare-unveils-disinfectant-tablets-to-fight-covid-19.html Wed, 19 Aug 2020 00:00:00 +0530 New Delhi based entrepreneur and founder of Akron Healthcare Pvt. Ltd., Arrjun Sehgal has come up with disinfectant tablets by the brand name: Akrosept that is helping people to disinfect a surface, objects, airtight packets, incoming couriers, fruits & vegetables etc. at homes, workplace, clinics, hospitals, restaurants, hotels & religious establishments. Solution prepared from Akrosept tablets is effective against bacteria, microbes, fungi, germs & viruses including coronavirus. Since April till July 2020, the firm has sold over 14 million Akrosept disinfection tablets. Akrosept tablets carry a 12-year legacy of being a preferred disinfectant amongst leading govt. & private hospitals, nursing homes & clinics. Sharing more information about the disinfectant tablets, Sehgal, said “While companies were focussing on selling Sanitizers, Masks, PPE and other products, there was no stable disinfectant in the market for protection from COVID-19. We identified this gap and launched Multipurpose Akrosept Tablets on E-Commerce and OTC/Chemist channels to make it accessible to general public for Household & Workplace Disinfection. The formula and active ingredient of Akrosept Powerful Disinfectant Tablets - NaDCC Sodium Dichloroisocyanurate has been recommended by WHO World Health Organisation for Disinfection of High Touch Areas, Surface & Objects to protect against Novel Coronavirus (Covid-19) as part of their Recommended Disease Commodity Package – Novel Coronavirus (nCoV). Akrosept is so far the most stable & superior disinfectant available as compared to Alcohol-Based Disinfectants & Sodium Hypochlorite. It releases stable Hypochlorous Acid in Water & poses no threat of sparking or catching fire like in case of alcohol-based disinfectants.” Akrosept is competitively priced, more economical & gives value for money in comparison to other disinfectants and sanitizers available in the market. ]]> <![CDATA[Akron Healthcare unveils disinfectant tablets]]> https://biospectrumindia.com/news/95/17062/akron-healthcare-unveils-disinfectant-tablets.html https://biospectrumindia.com/news/95/17062/akron-healthcare-unveils-disinfectant-tablets.html Wed, 19 Aug 2020 00:00:00 +0530 New Delhi based young entrepreneur, Arrjun Sehgal, Founder of Akron Healthcare has come up with disinfectant tablets by the brand name: Akrosept that is helping people to disinfect surface, objects, air tight packets, incoming couriers, fruits & gegetables etc. at homes, workplace, clinics, hospitals, restaurants, hotels & religious establishments. Solution prepared from Akrosept tablets is effective against bacteria, microbes, fungi, germs & viruses including COVID-19 coronavirus. Since April till July 2020, the firm has sold over 14 million Akrosept disinfection tablets. Akrosept tablets carry a 12 year legacy of being a preferred disinfectant amongst leading govt. & private hospitals, nursing homes & clinics. Akrosept is competitively priced, more economical & gives value for money in comparison to other disinfectants and sanitizers available in the market. “While companies were focussing on selling Sanitizers, Masks, PPE and other products, there was no stable disinfectant in the market for protection from COVID-19. We identified this gap and launched Multipurpose Akrosept Tablets on E-Commerce and OTC/Chemist channels to make it accessible to general public for Household & Workplace Disinfection. The formula and active ingredient of Akrosept Powerful Disinfectant Tablets - NaDCC Sodium Dichloroisocyanurate has been recommended by WHO World Health Organisation for Disinfection of High Touch Areas, Surface & Objects to protect against Novel Coronavirus (Covid-19) as part of their Recommended Disease Commodity Package – Novel Coronavirus (nCoV),” said Arrjun Sehgal. ]]> <![CDATA[Dr Reddy's announces the launch of AVIGAN for COVID-19 treatment]]> https://biospectrumindia.com/news/95/17064/dr-reddys-announces-the-launch-of-avigan-for-covid-19-treatment.html https://biospectrumindia.com/news/95/17064/dr-reddys-announces-the-launch-of-avigan-for-covid-19-treatment.html Wed, 19 Aug 2020 00:00:00 +0530 Hyderabad based Dr. Reddy’s Laboratories has announced the launch of AVIGAN® (Favipiravir) 200 mg Tablets in India. The launch is part of the global licensing agreement with FUJIFILM Toyama Chemical Co. Ltd. that grants Dr Reddy’s the exclusive rights to manufacture, sell and distribute AVIGAN (Favipiravir) 200 mg Tablets in India. AVIGAN® (Favipiravir) has been approved by the Drugs Controller General of India (DCGI) for the treatment of patients with mild to moderate COVID-19 disease. M V Ramana, Chief Executive Officer, Branded Markets (India and Emerging Markets), Dr. Reddy’s Laboratories, said "We are pleased to bring this important innovator medicine to the patients in India. The need for high quality and efficacy, affordability and better disease management are key priorities for us. We believe that AVIGAN® would provide an effective treatment option to the COVID-19 impacted patients in India.” Dr. Reddy’s AVIGAN® comes in a complete therapy pack of 122 tablets with a two-year shelf life. ]]> <![CDATA[Davaindia signs 180 new generic medical stores in India]]> https://biospectrumindia.com/news/95/17054/davaindia-signs-180-new-generic-medical-stores-in-india.html https://biospectrumindia.com/news/95/17054/davaindia-signs-180-new-generic-medical-stores-in-india.html Tue, 18 Aug 2020 13:55:00 +0530 Gujarat based Davaindia is India’s fastest growing retail chain of generic pharmacy powered by Zota Health Care Limited. Inspired by the revolutionary campaign by our Prime Minister for generic medicines, the company launched its lowest-priced generic medical stores, by the brand name of Davaindia. The company has so far 550 stores across India with 15,000,00 happy customers and already signed up 444 new store agreements which will be operative soon. The company aims to spread its wings pan-India by opening new stores in every village, town, city in the next two years’ time.   More than 1500 drugs, ayurvedic, gym supplements, OTC, nutraceuticals, surgical, cosmetics and wellness products are available in the stores of Davaindia. The company has signed up for 180 new stores in just one month. The company launched 50 new franchise stores in this month.   The company is also planning to add 250 new products soon to its existing range of products. The company is motivated by the Atmanirbhar Bharat scheme and plans to start this new type of store with a very small investment. The company has recently launched its Android app so that customers can check the rate difference of Generic Medicine and Branded Medicine even while sitting at home. They can also check the nearby store of Davaindia. An app for Apple phones users will be launched soon.   Generic Medicine costs up to 90% less as compared to branded medicines. Generic medicines are equally effective as branded medicines and consist of the same composition. The company aims to reach as many people as possible with the benefits of over-the-counter medicines as the company maintains a low MRP of the existing medicines.  ]]> <![CDATA[Atrimed Pharma brings plant based drug for COVID-19 treatment]]> https://biospectrumindia.com/news/95/17055/atrimed-pharma-brings-plant-based-drug-for-covid-19-treatment.html https://biospectrumindia.com/news/95/17055/atrimed-pharma-brings-plant-based-drug-for-covid-19-treatment.html Tue, 18 Aug 2020 00:00:00 +0530 Bengaluru based Atrimed Pharmaceuticals, a pioneer in developing scientifically tested plant based medication, announced that, three of its samples tested positive against SARS-CoV-2 in the ICMR (Indian Council for Medical Research) designated laboratory and the developed drug will be available as an oral medicine.  Company leverages proven ntiviral and Plpant based medicinal expertise to evaluate the new approaches for treating COVID-19.   Atrimed Pharma is dedicated to develop phytomolecule drugs for viral infections and other diseases, and takes pride that it has initiated a program to discover drug candidates for the treatment of patients infected with the novel coronavirus COVID-19, also known as SARS-CoV-2. Commenting on the exclusive breakthrough Dr. Hrishikesh Damle MD & CEO stated, “Based on our proven track record in virology and our capabilities in rare diseases, we believe our core competencies position us well to discover a potential treatment for COVID-19, and we are delighted to establish that three molecules out of ten submitted are passed the test and ready for human/clinical Trial for developing drug for the treatment of Coronavirus.” He further added that these molecules were ready for scientific research in the month of March 2020 itself but took so long for clearance. “Our decision to initiate a drug discovery for COVID-19 is a natural evolution of our work and mission. Regional Centre for Biotechnology has recognised and approved 3 effective plant molecules against COVID-19 and further studies will begin shortly."   ]]> <![CDATA[Fusion Health Care launches COVID-19 drug Favipiravir]]> https://biospectrumindia.com/news/95/17044/fusion-health-care-launches-covid-19-drug-favipiravir.html https://biospectrumindia.com/news/95/17044/fusion-health-care-launches-covid-19-drug-favipiravir.html Mon, 17 Aug 2020 12:45:00 +0530 Fusion Health Care Pvt Ltd, a leading innovative pharmaceutical company based at Hyderabad, has announced the launch of its Favipiravir drug under the brand name XARAVIR, for the treatment of mild to moderate COVID-19 cases. “It gives us immense satisfaction to launch ‘XARAVIR’ as this drug has the potential to save precious lives. We have launched the product at an affordable price and strive to make it available in sufficient quantities to meet the high demand for the drug in the Indian market,” stated Mr. Madhu Ramadugu, Managing Director. Fusion Health Care is known for its innovation - with many “First Time in India Products” which include – SCORBIX (Vitamin C 1.5 g Injection), DIFIDOX (Doxycycline Injection 100 mg) the No.1 brand in India predominantly used in treating Dengue, Malaria & Fever of unknown origin, STAPHONEX (Flucloxacillin Injection 1 g/500 mg), ISEP (Isepamicin Injection 200/400 mg) and many more. The company has recently launched an Immunity Booster product under the brand name D’FEND. It consists of Vitamin C 1000 mg + Zinc 10 mg, available in sugar-free orange flavor, in a tube of 20 effervescent tablets. The role & benefits of Vitamin C + Zinc have been published in many established journals that indicate to improve immunity and avoid Flu. Marking its 13th anniversary, Fusion Health Care inaugurated its R&D Facility in Hyderabad to bring innovative & affordable products for the Indian Market. ]]> <![CDATA[Fusion Health Care launches new drugs to fight COVID-19 ]]> https://biospectrumindia.com/news/95/17042/fusion-health-care-launches-new-drugs-to-fight-covid-19-.html https://biospectrumindia.com/news/95/17042/fusion-health-care-launches-new-drugs-to-fight-covid-19-.html Mon, 17 Aug 2020 00:00:00 +0530 Fusion Health Care, a leading innovative pharmaceutical company based at Hyderabad, has announced the launch of its Favipiravir drug under the brand name XARAVIR, for the treatment of mild to moderate COVID-19 cases.“It gives us immense satisfaction to launch ‘XARAVIR’ as this drug has the potential to save precious lives. We have launched the product at an affordable price and strive to make it available in sufficient quantities to meet high demand for the drug in the Indian market,” stated Mr. Madhu Ramadugu, Managing Director. Fusion Health Care is known for its innovation - with many “First Time in India Products” which include – SCORBIX (Vitamin C 1.5 g Injection), DIFIDOX (Doxycycline Injection 100 mg) the No.1 brand in India predominantly used in treating Dengue, Malaria & Fever of unknown origin, STAPHONEX (Flucloxacillin Injection 1 g/500 mg), ISEP (Isepamicin Injection 200/400 mg) and many more.The company has recently launched an Immunity Booster product under the brand name D’FEND. It consists of Vitamin C 1000 mg + Zinc 10 mg, available in sugar free orange flavour, in a tube of 20 effervescent tablets. The role & benefits of Vitamin C + Zinc have been published in many established journals that indicate to improve immunity and avoid Flu.Marking its 13th anniversary, Fusion Health Care inaugurated its R&D Facility in Hyderabad to bring innovative & affordable products for Indian Market.Fusion Health Care has a strong Pan-India presence with a field force of 600 employees and an innovative portfolio of Critical Care & Cardio-Diabetes products. ]]> <![CDATA[Biological E announces acquisition of Akorn India]]> https://biospectrumindia.com/news/95/17049/biological-e-announces-acquisition-of-akorn-india.html https://biospectrumindia.com/news/95/17049/biological-e-announces-acquisition-of-akorn-india.html Mon, 17 Aug 2020 00:00:00 +0530 Biological E. Limited (BE), a Hyderabad-based pharmaceuticals & Biologics company, has announced the acquisition of Akorn India Limited, a subsidiary of Akorn Inc., USA, for an undisclosed amount. By this strategic acquisition, BE, which manufactures specialty generic injectable medicines and also vaccines, will be able to enhance its manufacturing capabilities and capacities to produce & supply its vaccines and injectable medicines. BE is in the process of developing a COVID-19 vaccine and may be able to use the facilities at Akorn India Paonta Sahib Plant in Himachal Pradesh for commercial scale manufacture of the vaccine at the appropriate time. The Akorn India plant in Paonta Sahib, Himachal Pradesh has a fully staffed sterile injectable manufacturing facility with a 39,000 sq. mtrs of built up area spread over a 14-acre campus with an annual capacity for about 135 Million Units with the potential for immediate expansion of a further 30 Million Units. Mahima Datla, Managing Director, Biological E. Limited, said: “We are happy to have made a strategic investment in acquiring Akorn India.  We would leverage BE’s and Akorn India’s capabilities to enhance our supply capacities both in Vaccines and in Generic Injectables. The timing of this acquisition is fortuitous as it will immediately allow us to expand our capacity to manufacture our investigational COVID-19 vaccine.  With these capacities, we would be in a position to offer over 1 billion doses per annum.” Commenting on the acquisition, Narender Dev Mantena, Director, BioE Holdings Inc., who heads BE’s novel vaccines initiative, said “We are glad to have acquired Akorn India, which is known for its injectables and specialty sterile pharmaceuticals capabilities. This acquisition will allow us to expand our capacities to meet the increasing demands of our Specialty Generic Injectables for the US and EU customers. This acquisition will pave a new way for BE and add a significant value for our business operations and global supply of our products ]]> <![CDATA[Ajinomoto Bio-Pharma Services expands India facility]]> https://biospectrumindia.com/news/95/17035/ajinomoto-bio-pharma-services-expands-india-facility.html https://biospectrumindia.com/news/95/17035/ajinomoto-bio-pharma-services-expands-india-facility.html Fri, 14 Aug 2020 00:00:00 +0530 US based Ajinomoto Bio-Pharma Services ("Aji Bio-Pharma"), a leading provider of biopharmaceutical contract development and manufacturing services, is pleased to announce a major expansion of small molecule manufacturing capabilities with the addition of a new production facility in Visakhapatnam, India. Construction of the 8,500 square meter facility began at the end of July 2020 and is expected to be completed mid-2022. To meet the current and future needs of customers, the new small molecule manufacturing facility doubles the production capacity at the site to 310 m3 for active pharmaceutical ingredients (API) and intermediates and has dedicated equipment to manage OEB 4 high potency ingredients. Further, the site has completed renovations on existing laboratory space to support additional R&D activities. It is estimated that the expansion will create at least 60 new jobs at the site. The US FDA approved Ajinomoto Bio-Pharma Services India manufacturing site, which was designed, constructed and is managed based on the Aji Bio-Pharma Belgian sites' GMP operating standards and quality systems, has successfully supported a number of the world's leading biopharmaceutical companies since its formation in 2011 and continues to win awards for sustainability and quality standards. ]]> <![CDATA[Biological E inks licensing agreement with BCM for COVID-19 vaccine]]> https://biospectrumindia.com/news/95/17036/biological-e-inks-licensing-agreement-with-bcm-for-covid-19-vaccine.html https://biospectrumindia.com/news/95/17036/biological-e-inks-licensing-agreement-with-bcm-for-covid-19-vaccine.html Fri, 14 Aug 2020 00:00:00 +0530 Baylor College of Medicine in the US and Hyderabad based Biological E. Limited have announced a licensing agreement for the development of a safe, effective and affordable COVID-19 vaccine.   BE has licensed the recombinant protein COVID-19 vaccine candidate developed at Baylor. The company engaged in license negotiations with the BCM Ventures team, part of Baylor College of Medicine, after initial discussions on Baylor’s technology and how it could possibly inform a vaccine to address the current global pandemic. The company will leverage its past experience for the further development and commercialization of the vaccine candidate, which currently is produced using a proven yeast-based expression technology.   The current focus is on transfer of the technology for BE to initiate scale-up of the manufacturing process and undertake further development of the vaccine candidate. “BE is pleased to be a part of the global scientific effort aimed at exploring ways to respond to the COVID-19 pandemic. The partnership with Baylor would help accelerate the development of an affordable vaccine, especially for India and other low- and middle-income nations,” said Mahima Datla, managing director of BE. “We look forward to leveraging our capabilities for the development and manufacturing of this much needed vaccine. If the vaccine development is successful, we expect to make several hundred million doses of the vaccine available annually,” said Narender Dev Mantena, director of BioE Holdings Inc., who heads BE’s novel vaccine initiative. ]]> <![CDATA[BE partners with J&J for COVID-19 vaccine development]]> https://biospectrumindia.com/news/95/17033/be-partners-with-jj-for-covid-19-vaccine-development.html https://biospectrumindia.com/news/95/17033/be-partners-with-jj-for-covid-19-vaccine-development.html Thu, 13 Aug 2020 16:40:00 +0530 Hyderabad-based Biological E. Limited (BE) has entered into an agreement with Janssen Pharmaceutica NV (Janssen), one of the Janssen Pharmaceutical Companies of Johnson & Johnson, for the creation/enhancement of manufacturing capacities for drug substance and drug product for Johnson & Johnson’s COVID-19 vaccine candidate, Ad26.COV2.S.  Johnson & Johnson’s COVID-19 vaccine candidate is currently in Phase 1/2a clinical trials. Mahima Datla, Managing Director of BE said, “We are very pleased indeed to collaborate with an organization like Johnson & Johnson. Given the magnitude of the COVID-19 pandemic, our ability to mount an effective response will be predicated on the ability to supply the vaccine globally and in significant quantities. This is best achieved through collaboration.”    The WHO has declared COVID-19, caused by the novel coronavirus SARS-CoV-2, a pandemic. Globally; over 17 million confirmed cases of COVID-19, including over 686,000 deaths have been reported to the WHO. Currently, there is no approved vaccine for COVID-19. ]]> <![CDATA[Zydus launches most economical Remdesivir brand]]> https://biospectrumindia.com/news/95/17031/zydus-launches-most-economical-remdesivir-brand.html https://biospectrumindia.com/news/95/17031/zydus-launches-most-economical-remdesivir-brand.html Thu, 13 Aug 2020 13:00:00 +0530 Ahmedabad based Zydus, a leading discovery-based, global pharmaceutical company has announced that it has launched Remdesivir under the brand name RemdacTM in the Indian market. Priced at Rs. 2800 for a 100 mg lyophilized injection, RemdacTM is the most economical Remdesivir brand in India. The drug will be made available across India through the group’s strong distribution chain reaching out to Government and private hospitals treating COVID patients. “RemdacTM is the most affordable drug as we would like to enable patients to have access to this critical drug in the treatment of COVID 19”, said Dr. Sharvil Patel, the Managing Director of Cadila Healthcare Limited. “Through the course of this pandemic, our efforts have been focused on supporting people in this healthcare crisis, whether it is through developing vaccines, ramping up production and distribution of critical drugs and therapies, making diagnostic tests available or exploring new treatment options”, he added. ]]> <![CDATA[OSRAM suggests augmenting UV-C lamps production]]> https://biospectrumindia.com/news/95/17021/osram-suggests-augmenting-uv-c-lamps-production.html https://biospectrumindia.com/news/95/17021/osram-suggests-augmenting-uv-c-lamps-production.html Tue, 11 Aug 2020 17:00:00 +0530 Ultraviolet (UV-C) lamps have emerged as a dependable solution to disinfect the surroundings against bacteria, moulds, yeasts and viruses. German multinational lighting manufacturer Osram, one of the pioneers of UV-C Germicidal Lamps in the world, offers these lamps with unmatched European technology to enable a strong competitive edge for worldwide users. Today when the entire world is facing an unprecedented crisis caused by the pandemic, it’s time to brainstorm over the effective ways to disinfect air, water and surface that can help to mitigate the risk of acquiring infection. “Since long UV-C sterilization has been a proven way to sterilize and disinfect air, water and surfaces. The International Ultraviolet Association (IUVA) believes that UV disinfection technologies can play a role in a multiple barrier approach to reduce the transmission of bacteria and viruses based on empirical evidence,” said Avinder Singh, CEO - OSRAM Lighting Pvt. Ltd. India. OSRAM’s UV‑C HNS lamps work at a wavelength of 253.7 nm and obliterate viruses and bacteria with a reliability of 99.9 percent. The use in hospitals in Wuhan and Beijing, China, has confirmed their effectiveness against coronavirus. “Considering the effectiveness of UV-C Lamps worldwide, hospitals have been using devices fitted with UV-C lamps to disinfect air and surfaces. These devices are also used to disinfect the personal protective equipment due to their large-scale efficacy against the drug resistant bugs,” added Mr. Singh. ]]> <![CDATA[Lupin launches Zileuton extended-release tablets]]> https://biospectrumindia.com/news/95/17020/lupin-launches-zileuton-extended-release-tablets.html https://biospectrumindia.com/news/95/17020/lupin-launches-zileuton-extended-release-tablets.html Tue, 11 Aug 2020 16:15:00 +0530 Mumbai based Lupin Limited (Lupin) has announced the launch of Zileuton Extended-Release Tablets, 600 mg, having received approval from the United States Food and Drug Administration (U.S. FDA) earlier. The product would be manufactured at Lupin’s Nagpur facility, India.  Zileuton extended-release tablets, 600 mg, is the generic equivalent of Zyflo CR® Extended-Release Tablets, 600 mg, of Chiesi USA, Inc. and is indicated for the prophylaxis and chronic treatment of asthma in adults and children 12 years of age and older. Zileuton Extended-Release Tablets (RLD: Zyflo CR®) had an annual sale of approximately USD 40 million in the U.S. ]]> <![CDATA[Mankind, Daewoong Pharma to use Niclosamide for COVID-19 treatment]]> https://biospectrumindia.com/news/95/17019/mankind-daewoong-pharma-to-use-niclosamide-for-covid-19-treatment.html https://biospectrumindia.com/news/95/17019/mankind-daewoong-pharma-to-use-niclosamide-for-covid-19-treatment.html Tue, 11 Aug 2020 13:45:00 +0530 Daewoong Pharmaceutical Co. Ltd., South Korea (through its subsidiary, Daewoong Pharmaceutical India Pvt. Ltd.) and New Delhi based Mankind Pharma, fastest-growing Indian Pharmaceutical Company, have collaborated for conducting Phase I clinical trial of a long-acting intramuscular formulation of Niclosamide. The trial is designed towards addressing the need for a science-based investigation on this new formulation “Niclosamide (DWRX2003)” based on encouraging preclinical evidence for the treatment of COVID-19. Niclosamide (DWRX2003) is already in clinical use as an anthelmintic; however, the current formulation is expected to be a long-acting variant for this alternate clinical indication. It is also expected to circumvent the downside of oral administration. In vitro, Niclosamide (DWRX2003) was found to be 40, 26 & 15 times more potent than Remdesivir, Chloroquine & Ciclesonide respectively for its anti-viral action against SARS-CoV-2 virus. Also, the injectable intramuscular (IM) formulation of Niclosamide successfully removed the virus from lungs in animal tests, thereby countering viral infection, besides preventing cytokine storm which is the major cause of mortality in moderate to severe cases of COVID-19. Through intensive motivated research, Daewoong researchers worked on quick development of the formulation to have reached the stage of “First-in-Human” evaluation, successful completion of which would immensely facilitate COVID-19 disease treatment.   ]]> <![CDATA[Dr. Reddy's launches generic version of Ciprodex Otic Suspension]]> https://biospectrumindia.com/news/95/17017/dr-reddys-launches-generic-version-of-ciprodex-otic-suspension.html https://biospectrumindia.com/news/95/17017/dr-reddys-launches-generic-version-of-ciprodex-otic-suspension.html Tue, 11 Aug 2020 11:30:00 +0530 Dr. Reddy’s Laboratories Ltd. (Dr.Reddy’s), an Indian multinational pharmaceutical company based out in Hyderabad, recently announced the launch of Ciprofloxacin 0.3% and Dexamethasone 0.1% Otic Suspension, USP, a therapeutic equivalent generic version of Ciprodex® (ciprofloxacin 0.3% and dexamethasone 0.1%) Otic Suspension, approved by the U.S. Food and Drug Administration (USFDA). Marc Kikuchi, Chief Executive Officer, North America Generics, Dr. Reddy’s Laboratories commented, “We are pleased to launch this first-to-market generic product, illustrating our continued commitment to bringing affordable generic medicines to market for patients. At the same time, this product demonstrates that we are actively expanding the depth of our portfolio with our first otic suspension dosage form.” The Ciprodex® brand had U.S. sales of approximately $453 million MAT for the most recent twelve months ending in June 2020 according to IQVIA Health*. Dr. Reddy’s Ciprofloxacin 0.3% and Dexamethasone 0.1% Otic Suspension, USP, is available as 7.5 mL fill in a 10 mL bottle. ]]> <![CDATA[Vector Informatik supports COVID-19 testing for underprivileged citizens ]]> https://biospectrumindia.com/news/95/17016/vector-informatik-supports-covid-19-testing-for-underprivileged-citizens-.html https://biospectrumindia.com/news/95/17016/vector-informatik-supports-covid-19-testing-for-underprivileged-citizens-.html Tue, 11 Aug 2020 11:10:00 +0530 Mumbai based Vector Informatik globally helps shape social values through its extensive involvement and attempts to reduce the social risks facing the general public. In line with its values Vector Informatik India, a 100% subsidiary of Vector Informatik GmbH has undertaken initiatives to contribute and invest Rs 55 Lakhs towards COVID-19 testing amongst citizens from weaker section of society residing in Pune and Mumbai. Vector India has collaborated with Krsnaa Diagnostics in Pune and the testing will be done at identified sites for the people residing in low-income zones. In Mumbai, Vector India has partnered with voluntary organization, Be Human Foundation to facilitate testing at Brihan Mumbai Corporation (BMC) identified labs and a mobile vehicle is deployed for collection of samples which facilitates increased reach across the underprivileged sections of city. The entire project was planned by Vector India’s Corporate Social responsibility (CSR) committee in collaboration with Krsnaa Diagnostics, Pune and Be Human Foundation, Mumbai. Vector India employees have also taken efforts at their personal level to support stranded people in various parts of our country by volunteering for food distribution and contributed to different non-profit foundations working towards helping people affected by the pandemic. ]]> <![CDATA[Textile Industry gears for swiss polymer technology to beat COVID-19]]> https://biospectrumindia.com/news/95/17011/textile-industry-gears-for-swiss-polymer-technology-to-beat-covid-19.html https://biospectrumindia.com/news/95/17011/textile-industry-gears-for-swiss-polymer-technology-to-beat-covid-19.html Mon, 10 Aug 2020 13:00:00 +0530 An innovative product has emerged in the Indian textile industry that promises to render viruses such as coronavirus ineffective. The credit to bring this technology goes to N9 World Technologies, a subsidiary of Bengaluru Resil Chemicals, and Consolidated Pathways Inc., USA. The two firms signed an agreement to build unique Swiss antiviral and antimicrobial technologies into sustainable, cost effective custom blends for India's textile industry.  At the centre of the partnership is N9's unique organ functional polymer marketed under the umbrella brand VIROBAN. The durable antiviral technology from the house of N9 brings hygiene to textile materials, thereby helping improve the fabric's resilience against viruses’ including Coronavirus. The VIROBAN N9 XTS-18 creates a highly-cationic charge density on the textile’s surface, deactivating the spread of the virus & bacteria upon contact. The technology is highly effective against enveloped and capsid viruses, having proven in reducing infective viruses by 99.99% in ISO 18184 tests. The technology is designed to quickly prevent transmission of viruses. VIROBAN polymers are highly compatible with other textiles while remaining gentle on human skin. ]]> <![CDATA[StepOne launches national COVID telemed helpline in India]]> https://biospectrumindia.com/news/95/17006/stepone-launches-national-covid-telemed-helpline-in-india.html https://biospectrumindia.com/news/95/17006/stepone-launches-national-covid-telemed-helpline-in-india.html Mon, 10 Aug 2020 12:05:00 +0530 Delhi based StepOne, a non-profit volunteer-driven collective of 7000 doctors, has announced a National COVID Telemed Helpline, offering inclusive and 24x7 access to Healthcare experts to citizens of India, free of cost.  The helpline, +91-9745697456, is now live for citizens across the country living in the shadow of the rising pandemic. The helpline will provide TeleMed services under COVID related, mental help and video consultation for non-COVID related cases. Callers can share the basis of their symptoms which, if required, a doctor would call back and guide them on the next steps. StepOne has also come up with a web-based tele-screening bot that interacts with citizens who wish to share their symptoms and passes the information to a doctor based on the symptoms. It has also come up with a mental health helpline providing counseling to citizens for expressing their issues for appropriate resolutions. For the next phase of expanding its services, StepOne plans to launch a mobile app for citizens of the country to share their symptoms with a doctor remotely for e-consultation and free of charge. It has introduced and launched "Isolation Monitoring" services across 4 states to monitor citizens who have been recommended quarantine and if they are following the given protocols. ]]> <![CDATA[Pankajakasthuri completes trials of ZingiVir-H as adjunct therapy for COVID-19 patients]]> https://biospectrumindia.com/news/95/17002/pankajakasthuri-completes-trials-of-zingivir-h-as-adjunct-therapy-for-covid-19-patients.html https://biospectrumindia.com/news/95/17002/pankajakasthuri-completes-trials-of-zingivir-h-as-adjunct-therapy-for-covid-19-patients.html Fri, 07 Aug 2020 17:00:00 +0530 Trivandrum based Pankajakasthuri Herbals India Private Limited has announced significant success in their study to find a treatment for the novel coronavirus patients. The company released the successful completion of the clinical trials for its tablet, ZingiVir-H as an add-on therapy for the pandemic. The clinical trials were conducted on 116 patients infected by COVID-19 at medical colleges across the country, with 58 being administered Zingivir-H and the rest given a placebo.  The studies found that 58 patients treated with the herbo-mineral drug, ZingiVir–H recovered and reported a negative Reverse Transcription Polymerase Chain Reaction (RT-PCR) recovery in an average of 5 days while others took an average of 8 days to recover. The clinical trials of ZingiVir–H have been completed following the guidelines provided by the World Health Organization and the final results have been submitted to the Ministry of Ayurveda, Yoga & Naturopathy, Unani, Siddha and Homoeopathy (AYUSH) for approval. Talking about the completion of the clinical trials, Padma Shri Dr. J Hareendran Nair, Founder and MD of PKHIL and Pankajakasthuri Herbal Research Foundation said, “It gives me immense pride and honour to announce that our medication, ZingiVir –H, has been successful in providing much-needed assistance and help to COVID-19 patients in their recovery. I would like to commend my team who have rigorously helped me with the clinical trials and associated studies. This is one of the first herbo-mineral drug and ayurvedic medicine for COVID-19 that has achieved a negative RT PCR test as a primary endpoint.” The clinical studies took place at KR Hospital, Mysuru, Karnataka; RCSM Medical College and CPR Hospital, Kolhapur, Maharashtra; Saveetha Medical College and Hospital, Chennai, Tamil Nadu and ESIC Medical College and Hospital, Faridabad, Haryana. “We wanted to test the efficacy of the drug, which is made with seven ingredients, on patients in various hospitals across the country. This has further encouraged us and strengthened our belief that Ayurveda-based drugs can play a vital role in this fight against COVID-19. We are also soon planning to announce the results of the ongoing clinical trial with standalone treatment on 135 patients”, Dr. Nair added. Commenting on the Ministry of AYUSH to expedite the process of necessary approvals for all the Ayurveda drugs that are undergoing clinical trials in various hospitals in the country Dr. Nair said, “Today, when millions of people suffering from this harmful disease and are in hospitals battling the virus, I would like to urge the Ministry of AYUSH to support scientifically backed modern Ayurveda-based treatments and drugs that have long-lasting benefits and can help save lives. At PKHIL, we are equipped to scale up and meet the requirements of the nation, once necessary approvals are issued by the ministry.” Pankajakasthuri Herbals India Pvt. Ltd. submitted the first reports of ZingiVir-H to Ministry of AYUSH at the end of June 2020, while the interim report of 42 patients examined by a peer review committee was submitted on July 8th and the primary endpoint result of 116 patients was submitted to on July 24th. The company is expecting the final decision from the ministry soon. ]]> <![CDATA[Serum Institute sets COVID-19 vaccine price at Rs 225 per dose]]> https://biospectrumindia.com/news/95/17003/serum-institute-sets-covid-19-vaccine-price-at-rs-225-per-dose.html https://biospectrumindia.com/news/95/17003/serum-institute-sets-covid-19-vaccine-price-at-rs-225-per-dose.html Fri, 07 Aug 2020 17:00:00 +0530 Serum Institute of India (SII), the world’s largest vaccine manufacturer by volume, has entered into a new landmark partnership with Gavi, The Vaccine Alliance and the Bill & Melinda Gates Foundation, to accelerate the manufacture and delivery of up to 100 million doses of COVID-19 vaccines for India and low- and middle-income countries (LMICs). The collaboration will provide upfront capital to SII to help them increase manufacturing capacity now so that, once a vaccine, or vaccines, gains regulatory approval and WHO prequalification, doses can be produced at scale for distribution to India and LMIC as part of the Gavi COVAX AMC mechanism as early as the first half of 2021. The funding will support at-risk manufacturing by SII for candidate vaccines from AstraZeneca and Novavax, which will be available for procurement if they are successful in attaining full licensure and WHO Prequalification. SII has set an affordable ceiling price of US$ 3 or Rs 225.03 per dose. The arrangement also provides an option to secure additional doses if the vaccines pillar of the ACT Accelerator sees a need for it. "In an attempt to make our fight against COVID-19 stronger and all-embracing; SII has partnered with Gavi and the Bill & Melinda Gates Foundation to advance the manufacturing and delivery of up to 100 million doses of future COVID vaccines for India and low and middle income countries in 2021,” said Adar Poonawalla, CEO of Serum Institute of India. “The rampant spread of the virus has rendered the entire world in an unimaginable halt of uncertainty. And to ensure maximum immunization coverage and contain the pandemic, it is important to make sure that the most remote and poorest countries of the world have access to affordable cure and preventive measures. Through this association, we seek to ramp up our constant efforts to save the lives of millions of people from this dreadful disease.” The Gavi COVAX AMC, which is currently seeking at least US$ 2 billion in initial seed funding, will meet at least part of the cost of procurement for the vaccine doses. Last week the Gavi Board agreed the final list of 92 countries that will be supported by the AMC. Under the new collaboration, AstraZeneca’s candidate vaccine, if successful, will be available to 57 Gavi-eligible countries. Novavax’s candidate, if successful, will be available to all 92 countries supported by the AMC The collaboration between Gavi, SII, and the Gates Foundation supports the efforts of the ACT Accelerator's vaccines pillar, also known as COVAX, co-led by Gavi, the Coalition for Epidemic Preparedness Innovations (CEPI) and the World Health Organization (WHO), to accelerate the development of COVID-19 vaccines and ensure rapid, global access to them. Decisions around investment in manufacturing are taken in close collaboration between these three lead organisations of the COVAX pillar. ]]> <![CDATA[Wockhardt Foundation and Biogetica collaborate to combat COVID 19]]> https://biospectrumindia.com/news/95/16979/wockhardt-foundation-and-biogetica-collaborate-to-combat-covid-19.html https://biospectrumindia.com/news/95/16979/wockhardt-foundation-and-biogetica-collaborate-to-combat-covid-19.html Fri, 07 Aug 2020 00:00:00 +0530 Mumbai based Biogetica and Wockhardt Foundation have come together to conduct multidisciplinary research into remedies and strategies to effectively combat the Novel Corona Virus.  The research to develop the remedy is being conducted under Corival Life Sciences in Mumbai, which boasts of one of its kind partnerships between global leaders in the field of Natural & Pharmaceutical Medicines. Corival Life Sciences has conducted reviews of published ‘in vivo’, ‘in vitro’, and ‘in silica’ research on COVID 19 basis which their first product called ‘Immunofree’ was launched. Immunofree is now being entered into a pharma control trial along with reginmune, a product made by Biogetica that has already shown ground-breaking results in herpes trials.  The USP of the Corival Life Sciences protocol apart from all others is the fact that it combines evidence-based nutraceuticals and potent full-spectrum herbal extracts, into easy to use pills that synergistically work in multifaceted ways, during these unprecedented times. This protocol combines learnings from Allopathy, Ayurveda, TCM, and Vibrational therapies. Immunofree blends a wide variety of phytochemicals, such as alkaloids, polyphenols, flavonoids, saponins, terpenoids, lignans, Xantones, etc. These herbs have specifically been chosen based on research done in 2020. ‘Immunofree’ serves as a multifaceted solution to the issues prevalent today. This is a one of kind partnership between pharmaceutical and herbal medicine providers and it has yielded a specific multifaceted formula for this unprecedented time. ]]> <![CDATA[Alkem Labs launches Alfluenza for COVID-19 treatment]]> https://biospectrumindia.com/news/95/16991/alkem-labs-launches-alfluenza-for-covid-19-treatment.html https://biospectrumindia.com/news/95/16991/alkem-labs-launches-alfluenza-for-covid-19-treatment.html Fri, 07 Aug 2020 00:00:00 +0530 The cases of COVID-19 is increasing significantly globally and India too is affected with around 50,000 new cases being added on a daily basis. In this backdrop, Mumbai based Alkem Laboratories Ltd. has launched Favipiravir under the brand name “Alfluenza” in India for the management of mild to moderate cases of COVID-19. Favipiravir is approved by DCGI (Drug Controller General of India) for restricted emergency use in India. Restricted use entails responsible medication use where every patient must have signed informed consent before treatment initiation. ]]> <![CDATA[Lupin signs pact with ForDoz for 2 complex injectable assets]]> https://biospectrumindia.com/news/95/16995/lupin-signs-pact-with-fordoz-for-2-complex-injectable-assets.html https://biospectrumindia.com/news/95/16995/lupin-signs-pact-with-fordoz-for-2-complex-injectable-assets.html Fri, 07 Aug 2020 00:00:00 +0530 Mumbai based pharma major Lupin Limited (Lupin) recently announced that its U.S. based wholly-owned subsidiary Lupin Pharmaceuticals Inc. has entered into an agreement with ForDoz Pharma Corp (ForDoz) for granting Lupin the exclusive rights to market and distribute 2 complex injectable assets in advanced stages of development in the U.S. and its territories.  The two assets are in the Oncology and Anti-infective therapeutic areas which when approved, will provide affordable alternatives to patients and healthcare professionals. The assets will be manufactured in ForDoz’s U.S. based manufacturing site and ForDoz will be responsible for the development and obtaining the necessary regulatory approvals. Lupin shall leverage its existing commercial infrastructure for the marketing and distribution of the two assets.    According to Alok Sonig, CEO, US Generics and Global Head, Generics R&D and Biosimilars, “The partnered assets are a key, strategic addition to our complex injectables pipeline and will bolster our Institutional business offering. These assets will complement Lupin’s ongoing organic R&D efforts in complex assets including inhalation and long-acting injectables as well as Biosimilars.”   ]]> <![CDATA[Lupin in alliance with Concord receives USFDA approval for Mycophenolate Mofetil ]]> https://biospectrumindia.com/news/95/16993/lupin-in-alliance-with-concord-receives-usfda-approval-for-mycophenolate-mofetil-.html https://biospectrumindia.com/news/95/16993/lupin-in-alliance-with-concord-receives-usfda-approval-for-mycophenolate-mofetil-.html Thu, 06 Aug 2020 16:05:00 +0530 An Indian multinational pharmaceutical company headquartered in Mumbai, Lupin Limited (Lupin) in alliance with Concord Biotech Limited (Concord) recently announced that it has received approval from the United States Food and Drug Administration (U.S. FDA) for Mycophenolate Mofetil Tablets USP, 500 mg, to market a generic version of CellCept® Tablets of Roche Palo Alto LLC (Roche). Mycophenolate Mofetil Tablets are indicated for the prophylaxis of organ rejection in recipients of allogeneic kidney, heart or liver transplants, in combination with other immunosuppressants. Mycophenolate Mofetil Tablets USP, 500 mg (RLD: CellCept®) had an annual sale of approximately USD 96 million in the U.S. (IQVIA MAT Mar 2020). ]]> <![CDATA[Glenmark introduces higher strength of FabiFlu drug]]> https://biospectrumindia.com/news/95/16992/glenmark-introduces-higher-strength-of-fabiflu-drug.html https://biospectrumindia.com/news/95/16992/glenmark-introduces-higher-strength-of-fabiflu-drug.html Thu, 06 Aug 2020 14:00:00 +0530 Mumbai based Glenmark Pharmaceuticals announced that it will introduce a 400 mg version of oral antiviral FabiFlu®, for the treatment of mild to moderate COVID-19 in India. The higher strength will improve patient compliance and experience, by effectively reducing the number of tablets that patients require per day. A higher pill burden has been associated with lower adherence to therapy, the latter affecting viral suppression and overall treatment outcomes. Also reducing the pill burden has been a demand from doctors and patients to enable adherence. The 200 mg dosage of FabiFlu® required patients to take 18 tablets on Day 1 (nine in the morning and nine in the evening), followed by 8 tablets each day thereafter for a maximum of 14 days. With the new 400 mg version, patients will now have a more relaxed dosage regimen, with 9 tablets required on Day 1 (4.5 in the morning and 4.5 in the evening), and thereafter 2 tablets twice a day from Day 2 till end of the course. Explaining the significance of this development, Dr. Monika Tandon, Vice President & Head, Clinical Development, Global Specialty/Branded Portfolio, Glenmark Pharmaceuticals Ltd., said, “Being the first company to launch Favipiravir in India, we continue to innovate and seek new treatment options for Covid-19 patients. Introducing this higher strength of FabiFlu® is in line with these efforts to ensure a smoother experience for patients, by reducing their daily pill burden.” “The 200 mg dosage of FabiFlu® was developed in line with global formulations of the drug Favipiravir, which had similar strength. The 400 mg version is a result of Glenmark’s own R&D efforts to improve treatment experience for patients in India,” she added. ]]> <![CDATA[Cadila Pharma launches osteoporosis biosimilar in India]]> https://biospectrumindia.com/news/95/16986/cadila-pharma-launches-osteoporosis-biosimilar-in-india.html https://biospectrumindia.com/news/95/16986/cadila-pharma-launches-osteoporosis-biosimilar-in-india.html Thu, 06 Aug 2020 00:00:00 +0530 Ahmedabad-based Cadila Pharmaceuticals Limited has announced the launch of NuPTH an Osteoporosis biosimilar of Forteo in India. The Forteo biosimilar is used for the treatment of osteoporosis and in patients with increased risk of fracture. India is the Osteoporosis capital of the world. It is a very common problem. As per a study in 2003 the number of osteoporosis patients in India were approximately 26 million. It is estimated that by 2050, half of the world's fractures will occur in Asia. “Difficulty in use and early drop-outs is often cited as a common reason for non-compliance of osteoporosis medication. The medication is primarily used by people of 50 years and above. We realized that if the delivery system is complex, people stop using it. The ease of use of delivery device is as important as the development of new drugs. The biosimilar NuPTH aims to be a cost-effective solution for patients and will be sold as an easy to use, pre-filled disposable pen,” shared Amit Ajmera, Vice President, Cadila Pharmaceuticals Limited. “Cadila has always been committed to quality and affordable care. With the launch of NuPTH, we intend to strengthen our orthocare portfolio and help increase choice, and access for osteoporosis care to patients in the Indian Market. NuPTH builds new bones with ease, and we want all patients to have access to it. Biosimilars market is a focus area for us and we will continue to strengthen our portfolio”, said Mr. O.P. Singh, President -Sales and Marketing, Cadila Pharmaceuticals Limited. NuPTH is the third biosimilar announced by the organization in the past one month. The pharma giant has recently launched Rituximab and Bevasizumab biosimilars, recommended in multiple indications under the brand names Ritucad™ and Bevaro™ respectively. ]]> <![CDATA[Pfanstiehl Launches New cGMP Histidine and Histidine HCl]]> https://biospectrumindia.com/news/95/16988/pfanstiehl-launches-new-cgmp-histidine-and-histidine-hcl.html https://biospectrumindia.com/news/95/16988/pfanstiehl-launches-new-cgmp-histidine-and-histidine-hcl.html Thu, 06 Aug 2020 00:00:00 +0530 Following a record 100th year in business, Pfanstiehl has launched high purity, low endotoxin, low metal L-Histidine and L-Histidine Hydrochloride Monohydrate and established a new quality standard for amino acids.  Amino acids are critical components utilized in bioprocessing for both upstream and downstream applications. With the ever-increasing regulatory requirements placed on bioprocessing components, there is a drive towards using higher- quality products when available. Availability of high-quality amino acids for the biopharma market has been a challenge, which is why many customers enlisted Pfanstiehl to help develop a better alternative.  Pfanstiehl’s new L-Histidine High Purity / Low Endotoxin-Low Metals-USP, EP, JP, ChP (H-116) and L-Histidine Hydrochloride Monohydrate, High Purity / Low Endotoxin-Low Metals, EP, JP, ChP (H-117) products have market leading specifications which show a tight control of endotoxin and trace metal impurities reflected with Elemental Impurity Data in parts per billion on their specifications. These products are suitable for bioprocessing, solubilization and stabilization applications.  “Pfanstiehl’s amino acid specifications exceed regulatory requirements and reflect our leadership in setting high quality industry standards for the biopharma market” – Hemasunder Reddy, Director of Business Development APAC  As a US-based manufacturer, Pfanstiehl’s Quality Systems are based on ICH Q7 “Good Manufacturing Practice Guide for Active Pharmaceutical Ingredients” guidelines. Pfanstiehl has Drug Master Files in process for these products.  Prior to launching any new product, Pfanstiehl completes full product characterization while validation is done at full scale. Pfanstiehl offers complimentary product characterization data to their customers, understanding the criticality of such information. This shows their commitment to customers’ success, as they deliver world-class levels of quality and consistency.  Commercial material and samples for both Histidine products are now available for customer qualification and manufacturing, along with product profiles and regulatory documentation.  In everything they do, Pfanstiehl is motivated by a concern for both product quality and commitment to their valued customers. ]]> <![CDATA[Thermo Fisher launches exclusive website for chemical business offerings in India]]> https://biospectrumindia.com/news/95/16983/thermo-fisher-launches-exclusive-website-for-chemical-business-offerings-in-india.html https://biospectrumindia.com/news/95/16983/thermo-fisher-launches-exclusive-website-for-chemical-business-offerings-in-india.html Wed, 05 Aug 2020 16:45:00 +0530 Thermo Fisher Scientific, the world leader in serving science, announced the launch of a new website for its chemicals business offerings in India. This website will serve as a dedicated platform towards an extensive range of Laboratory and Production chemicals. The new website will bring all major chemical brands from Thermo Fisher Scientific including Alfa Aesar, Acros Organics, Fisher Chemicals, Qualigens, Fisher Bioregaents and Maybridge under one umbrella.   Qualigens, the locally manufactured brand in India, will have its first online presence through this website. This will enable customers to explore the chemical portfolio and have a consistent digital experience.   Thermo Fisher invites customers from various segments including educational institutions, research, and development, pharmaceuticals, diagnostics, food & beverage and environmental sector. The website is equipped with customized chemical search capabilities like structure search and element search and options to view availability and pricing for specific brands. The website has also been designed to cater to distinct purchase lifecycles of buyers and customers, who can also explore on-demand seminars and technical literature. ]]> <![CDATA[BDR receives DCGI approval for launching Favipiravir in India]]> https://biospectrumindia.com/news/95/16978/bdr-receives-dcgi-approval-for-launching-favipiravir-in-india.html https://biospectrumindia.com/news/95/16978/bdr-receives-dcgi-approval-for-launching-favipiravir-in-india.html Wed, 05 Aug 2020 14:35:00 +0530 Mumbai based BDR Pharmaceuticals recently announced the launch of Favipiravir for the treatment of COVID-19 patients in India.  BDR Pharma has received approval from the Drugs Controller General of India (DCGI) to manufacture Favipiravir to treat mild to moderate patients with Covid-19 symptoms under the brand name BDFAVI. This approval comes after being one of the first companies to develop Remdesivir in the country and supply it on compassionate grounds to those suffering from the virus BDR Pharma has persistently been at the forefront in supporting India’s fight against COVID-19. In the short span of 4 months the company has launched 2 path-breaking drugs, to meet the increasing patients’ needs and provide timely therapy options during the pandemic. Favipiravir, an antiviral drug used for the treatment of influenza in Japan since 2014, was approved by Drug Controller General of India for the treatment of mild to moderate cases of COVID-19 in India. Favipiravir confirmed encouraging clinical evidence, with positive results in mild to moderate Covid-19 cases. BDR pharma has developed Favipiravir tablets in 200mg strengths with a strip of 10 tablets with the highest safety and manufacturing protocols in place to meet national and international demands. ]]> <![CDATA[Zydus commences Ph II trial of ZyCoV-D vaccine]]> https://biospectrumindia.com/news/95/16980/zydus-commences-ph-ii-trial-of-zycov-d-vaccine.html https://biospectrumindia.com/news/95/16980/zydus-commences-ph-ii-trial-of-zycov-d-vaccine.html Wed, 05 Aug 2020 14:10:00 +0530 Ahmedabad based Zydus Cadila, an innovation driven global pharmaceutical company focused on discovering and developing NCEs, Novel Biologicals, Biosimilars and Vaccines, has announced that its plasmid DNA vaccine to prevent COVID-19, ZyCoV-D was found to be safe and well tolerated in the Phase I clinical trial. The company has commenced Phase II clinical trials from the 6th of August, 2020. The company reports that the doses of the vaccine administered to healthy volunteers in the Phase I clinical trial, which began on 15th July 2020, has been well tolerated. Previously, the vaccine was found to be safe, immunogenic and well tolerated in the pre-clinical toxicity studies. The vaccine was able to elicit high level of neutralizing antibodies in animal studies. “The Phase I dosing to establish the safety of ZyCoV-D is an important milestone,” said Mr. Pankaj R. Patel, Chairman Zydus Cadila. “All the subjects in Phase I clinical trial were closely monitored in a clinical pharmacological unit for 24 hours post dosing for safety and for 7 days thereafter and vaccine was found to be very safe. We now begin the Phase II clinical trials and look forward to evaluating the safety and immunogenicity of the vaccine in a larger population.” The 7 day safety of the vaccine in all the subjects enrolled in the Phase I clinical trial has been endorsed by the independent Data Safety Monitoring Board (DSMB), which has been constituted to oversee the safety aspects of the clinical trial. The Phase II study of ZyCoV-D will be conducted in over 1000 healthy adult volunteers as part of the Adaptive Phase I/II dose escalation, multicentric, randomized, double-blind placebo controlled study. ]]> <![CDATA[Lupin launches Covihalt for treatment of COVID-19]]> https://biospectrumindia.com/news/95/16977/lupin-launches-covihalt-for-treatment-of-covid-19.html https://biospectrumindia.com/news/95/16977/lupin-launches-covihalt-for-treatment-of-covid-19.html Wed, 05 Aug 2020 12:45:00 +0530 Mumbai based pharma major Lupin Limited (Lupin) recently announced the launch of Favipiravir in India under the brand name Covihalt® for the treatment of mild to moderate COVID-19. Favipiravir has received authorization from the Drug Controller General of India (DCGI) for emergency use. Lupin’s Covihalt® dosage strength has been developed keeping in mind the convenience of administration. It is available as 200 mg tablets in the form of a strip of 10 tablets and priced at Rs. 49 per tablet.   Rajeev Sibal, President - India Region Formulations (IRF) commented on this development, “Lupin has always been committed to the fight against life-threatening diseases. COVID-19 is a global pandemic and in India, we are seeing a surge in the number of cases on a daily basis. Covihalt®, Lupin’s Favipiravir drug, is a vital step in this direction. We believe that we can leverage our expertise in managing widespread community diseases like TB to proactively reach patients across India and ensure access to Covihalt® through our strong distribution network and field force.”   ]]> <![CDATA[Zenara Pharma receives DCGI approval for Favipiravir tablets ]]> https://biospectrumindia.com/news/95/16976/zenara-pharma-receives-dcgi-approval-for-favipiravir-tablets-.html https://biospectrumindia.com/news/95/16976/zenara-pharma-receives-dcgi-approval-for-favipiravir-tablets-.html Wed, 05 Aug 2020 12:15:00 +0530 Hyderabad-based Zenara Pharma has announced that it has received approval from the Drugs Controller General of India (DCGI), to manufacture and sell Favipiravir tablets as a treatment option for patients with mild to moderate symptoms of Covid-19. The tablet, which will be sold under the brand name ‘Favizen’, is being manufactured at Zenara’s US FDA approved state-of-the-art facility in Hyderabad.  Dr. Jagadeesh Babu Rangisetty, Co-founder and Managing Director, commented, “I am proud to say that we have our own in-house API and are not dependent on any imports for the production. We believe that this will ensure the stability and rapid production and availability of this treatment for the Indian market. We are also in talks with various institutions to make the tablets available at discounted or no cost to underprivileged patients.”  Zenara Pharma is in talks with multiple state institutions and several hospitals in India to ensure that Favizen is readily available for patients in need. The company is also likely to tie up with other partners across the country to increase patient coverage. Internationally, Zenara has the manufacturing and distribution capabilities to improve access to this treatment around the world and has already begun exports to the Middle East and Latin American countries. So far, Favipiravir has demonstrated positive clinical outcomes in some trials and has already been approved for use to treat Covid-19 in Russia and parts of the Middle East. Advanced stage trials are currently underway in several countries including India. ]]> <![CDATA[Lupin receives tentative approval for Empagliflozin tablets]]> https://biospectrumindia.com/news/95/16973/lupin-receives-tentative-approval-for-empagliflozin-tablets.html https://biospectrumindia.com/news/95/16973/lupin-receives-tentative-approval-for-empagliflozin-tablets.html Tue, 04 Aug 2020 17:20:00 +0530 An innovation-led transnational pharmaceutical company headquartered in Mumbai, Lupin Limited (Lupin) has recently announced that it has received tentative approval for its Empagliflozin Tablets, 10 mg, and 25 mg, from the United States Food and Drug Administration (U.S. FDA) to market a generic version of Jardiance® Tablets, 10 mg, and 25 mg, of Boehringer Ingelheim Pharmaceuticals, Inc. Empagliflozin Tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Empagliflozin Tablets, 10 mg and 25 mg (RLD: Jardiance®) had an annual sale of approximately USD 4,368 million in the U.S. (IQVIA MAT Mar 2020). ]]> <![CDATA[Converge Biotech launches Vergiflu for COVID-19 treatment]]> https://biospectrumindia.com/news/95/16970/converge-biotech-launches-vergiflu-for-covid-19-treatment.html https://biospectrumindia.com/news/95/16970/converge-biotech-launches-vergiflu-for-covid-19-treatment.html Tue, 04 Aug 2020 10:10:00 +0530 Converge Biotech, a leading healthcare company based at Hyderabad, has announced the launch of generic Favipiravir tablet in India. It will be marketed under the brand name ‘VERGIFLU’ and is indicated for use in mild to moderate COVID-19 patients. Vergiflu is orally administered making it a convenient treatment option. Favipiravir is an off patent; broad spectrum oral anti-viral drug backed by strong clinical evidence and has been shown to hasten clinical recovery in COVID -19 patients with mild to moderate symptoms. The drug is already approved for novel or re-emerging pandemic influenza virus infection in Japan since 2014, where high recovery rates have been reported with both 7 and 14 days of therapy in both mild and moderate patients. The drug has shorter viral clearance and faster recovery rate and is reported to have a wide therapeutic safety margin for COVID-19 dose.The mechanism of action of Favipiravir is novel compared to existing influenza antivirals that primarily prevent entry and exit of the virus from cells. The drug has high affinity to RNA virus specific RNA polymerase and gets converted into an active phosphoribosylated form (favipiravir-RTP) in cells thereby inhibiting RNA polymerase activity.The product is available from today in all major hospitals across the country. It will be sold only on prescription and the company will make sure that the drug is available to the patients.Converge Biotech also has Prabinex HD (Injection vitamins c 1.5 g), Doxiverge (Inj Doxycycline 100 mg) and Oxihalt (Inj Glutathione 600mg) for hospitalised patients along with immunity boosters, Prabinex 500 mg (Tab Vitamin C 500mg) and Prabinex Z (Tab Vitamin C 500mg with Zinc 20mg); Divify (Vitamin D3 strips) and Tancyvit (Multivitamin). ]]> <![CDATA[Jubilant aims at making JUBI-R available to over 1000 hospitals]]> https://biospectrumindia.com/news/95/16968/jubilant-aims-at-making-jubi-r-available-to-over-1000-hospitals.html https://biospectrumindia.com/news/95/16968/jubilant-aims-at-making-jubi-r-available-to-over-1000-hospitals.html Tue, 04 Aug 2020 06:50:00 +0530 Noida headquartered Jubilant Life Sciences Limited, an integrated global pharmaceutical and life sciences company, is pleased to announce that its subsidiary, Jubilant Generics Limited, has launched remdesivir for injection under the brand name ‘JUBI-R’ in the Indian market at a price of Rs 4,700 per vial of 100 mg (lyophilized injection). The Company will make the drug available to over 1,000 hospitals providing COVID-19 treatment in India through its distribution network. Jubilant’s 24 hour help line will enhance access to ‘JUBI-R’ during these pandemic times, where timely access to the drug may prove critical to treatment outcomes. In order to increase accessibility of ‘JUBI-R’ to patients below the poverty line and to front line paramedical staff, Jubilant Bhartia Foundation, a not-for-profit organisation of Jubilant Group, is launching unique programs in India aimed at distribution of the drug. “It gives us immense satisfaction to launch ‘JUBI-R’ as this drug has a potential to save precious lives across the globe. We have launched the product at affordable prices and strive to make it available in sufficient quantities to meet high demand for the drug in the Indian market and in other countries,” stated Mr. Shyam S. Bhartia, Chairman & Managing Director and Mr. Hari S. Bhartia, Co-Chairman, Jubilant Pharma Limited.  “The Company’s ability to launch this product in such short timelines highlights our R&D and manufacturing capabilities and our continued commitment to provide leading healthcare solutions. Through the Jubilant Bhartia Foundation, we will distribute the drug on compassionate basis to save precious lives of people through unique programs.” ]]> <![CDATA[Sun Pharma launches Favipiravir at most affordable price]]> https://biospectrumindia.com/news/95/16972/sun-pharma-launches-favipiravir-at-most-affordable-price.html https://biospectrumindia.com/news/95/16972/sun-pharma-launches-favipiravir-at-most-affordable-price.html Tue, 04 Aug 2020 05:05:00 +0530 Mumbai based Sun Pharmaceutical Industries Limited recently announced that it has launched FluGuard® (Favipiravir 200 mg) at an economical price of Rs. 35 per tablet, for the treatment of mild to moderate cases of Covid-19 in India. Favipiravir is the only oral anti-viral treatment approved in India for the potential treatment of patients with mild to moderate Covid-19 disease. Kirti Ganorkar, CEO of India Business, Sun Pharma commented, “With over 50,000 Covid-19 cases being reported daily in India, there is an urgent need to provide more treatment options to healthcare professionals. We are launching FluGuard® at an economical price to make the drug accessible to more and more patients thereby reducing their financial burden. This is in line with our continuous efforts to support India’s pandemic response.” The company will work closely with the government and medical community to ensure the availability of FluGuard® to patients across the country. The stocks of FluGuard® will be available in the market from this week. ]]> <![CDATA[Wockhardt announces COVID-19 vaccine partnership with UK ]]> https://biospectrumindia.com/news/95/16967/wockhardt-announces-covid-19-vaccine-partnership-with-uk-.html https://biospectrumindia.com/news/95/16967/wockhardt-announces-covid-19-vaccine-partnership-with-uk-.html Mon, 03 Aug 2020 16:50:00 +0530 Mumbai based Wockhardt, the global pharmaceutical and biotechnology major has announced that it has entered into an agreement with the UK Government to fill-finish COVID-19 vaccines. The manufacturing will be undertaken at CP Pharmaceuticals, a subsidiary of Wockhardt based in Wrexham, North Wales.  As per the terms of the agreement the company has reserved manufacturing capacity to allow for the supply of multiple vaccines to the UK Government in its fight against COVID19, including AZD1222, the vaccine co-invented by the University of Oxford and its spinout company, Vaccitech and licensed by AstraZeneca. Dr. Habil Khorakiwala, Founder Chairman of Wockhardt emphasized, “The pandemic of COVID-19 is a challenge for all and needs a concerted effort to overcome. We are proud to be collaborating with the UK Government to make vaccines available and the arrangement brings in a huge sense of purpose and pride, it upholds our ongoing commitment to fighting against such a pandemic of global human importance. As a global organization, we are focussed and committed to assisting in mitigating the worldwide impact of COVID-19.”  The government has reserved one fill and finish production line for its exclusive use for the next 18 months in order to guarantee the supply of vaccines required to fight COVID-19 in the UK. In the UK, Wockhardt is one of the largest suppliers in the NHS for over 20 years, has had a presence in Wrexham for over two decades, and employs over 400 people at its 612,000 square feet high-tech manufacturing facility.  ]]> <![CDATA[DCGI approves Serum Institute for Phase II+III trials of Oxford University vaccine ]]> https://biospectrumindia.com/news/95/16966/dcgi-approves-serum-institute-for-phase-iiiii-trials-of-oxford-university-vaccine-.html https://biospectrumindia.com/news/95/16966/dcgi-approves-serum-institute-for-phase-iiiii-trials-of-oxford-university-vaccine-.html Mon, 03 Aug 2020 13:00:00 +0530 The Drugs Controller General of India (DCGI) has given approval to Serum Institute of India, Pune to conduct Phase II+III clinical trials of Oxford University-Astra Zeneca COVID-19 vaccine (COVISHIELD) in India. This will hasten the development of the COVID-19 vaccine. "We will begin with the trials for the vaccine in India. In addition, we will soon start manufacturing the vaccine in large volumes", said Adar Poonawalla, CEO, Serum Institute of India. Oxford and AstraZeneca are collaborating with clinical partners around the world as part of a global clinical programme to trial the Oxford vaccine. The global programme is made up of a Phase III trial in the US enrolling 30,000 patients, a paediatric study, as well as Phase III trials in low-to-middle income countries including Brazil and South Africa which are already underway. AstraZeneca remain committed to fulfilling their commitment for broad and equitable access to the vaccine, should late-stage clinical trials prove successful. So far, commitments to supply more than 2 billion doses of the vaccine have been agreed with the UK, US, Europe’s Inclusive Vaccines Alliance (IVA), the Coalition for Epidemic Preparedness (CEPI), Gavi the Vaccine Alliance and Serum Institute of India. ]]> <![CDATA[Tattvan E-clinics offer affordable & customized tele-health solutions ]]> https://biospectrumindia.com/news/95/16953/tattvan-e-clinics-offer-affordable-customized-tele-health-solutions-.html https://biospectrumindia.com/news/95/16953/tattvan-e-clinics-offer-affordable-customized-tele-health-solutions-.html Fri, 31 Jul 2020 14:00:00 +0530 In the time of the pandemic, many companies are evaluating options to provide hassle-free solutions for the well-being of their employees and improve efficiency and productivity. To improvise the well-being of employees, Delhi based Tattvan e-clinics are creating value by offering extremely affordable and customized tele-health solutions for corporate employees. A virtual tele-health ecosystem for corporate employees including specialized support for COVID19 is changing workplace wellbeing dynamics. Tattvan’s workplace wellbeing program is of particular use to companies in times of ‘work from home’. The program helps companies to reduce employee healthcare costs, boost productivity, improve employee satisfaction with the company, and also create a culture of solid employee engagement.  With the help, mobile application one can book Appointments, do unlimited text, phone or video consultations with specialists from Modern medicine, Ayurveda, and Homeopathy, track 50+ parameters via our trackers on daily basis, participate in remote monitoring programs and much more, participate in mental wellbeing programs, get unlimited access to Tattvan’s Second Opinion Service, unlimited physiology and vital diagnostics, discounts on pathology and radiology tests and also maintain their own and family members health records online and share with physicians. ]]> <![CDATA[Dassault Systemes partners in Drug Discovery Hackathon 2020]]> https://biospectrumindia.com/news/95/16945/dassault-systemes-partners-in-drug-discovery-hackathon-2020.html https://biospectrumindia.com/news/95/16945/dassault-systemes-partners-in-drug-discovery-hackathon-2020.html Fri, 31 Jul 2020 07:15:00 +0530 Bengaluru based Dassault Systemes has partnered in the Drug Discovery Hackathon 2020 (DDH2020), a joint initiative of AICTE (All India Council for Technical Education), CSIR (Council of Scientific and Industrial Research), CDAC (Centre for Development of Advanced Computing) and supported by the Office of Principal Scientific Advisor, Govt. of India, NIC (National Informatics Centre) and MyGov. Under the partnership, Dassault Systèmes is offering academic researchers, faculty and participants of the hackathon, access to BIOVIA Discovery Studio powered by 3DEXPERIENCE platform to assist in the search for rapid, safe and effective therapeutic drugs against COVID-19. The Drug Discovery Hackathon 2020 (DDH2020) vision and mission is to establish an “open innovation model” for in silico drug discovery against COVID-19 and will cover the various processes in drug discovery including, but not limited to, in silico screening of molecules, lead optimization and identification of druggable non-toxic targets. The targets, tools, or lead molecules identified through the process of DDH2020 will be taken forward for synthesis followed by subsequent steps in a routine drug discovery program. As an active supporter of the scientific community worldwide that is collaborating on COVID-19 solutions, Dassault Systèmes has developed BIOVIA Discovery Studio. It provides researchers with a complete toolset for use, from target identification through lead optimization including tools for biologics design and analysis, classical simulations, structure- and fragment-based design, virtual ligand screening, as well as ADME (Absorption, Distribution, Metabolism, Excretion) and toxicity prediction. ]]> <![CDATA[BSVL pledges Rs 10 L to support IVF treatments]]> https://biospectrumindia.com/news/95/16949/bsvl-pledges-rs-10-l-to-support-ivf-treatments.html https://biospectrumindia.com/news/95/16949/bsvl-pledges-rs-10-l-to-support-ivf-treatments.html Thu, 30 Jul 2020 19:05:00 +0530 Mumbai based Bharat Serums and Vaccines Ltd. (BSVL), recently announced a corpus of Rs 10 lacs towards a fund to support IVF treatment for couples who are eligible but poor at the ‘India IVF Summit’ by Integrated Health and Wellbeing (IHW) Council. Mr. Sanjiv Navangul, Managing Director and CEO, BSVL added that the company will conduct a multi-stakeholder study to quantify the economic cost of infertility.  Leading gynecologists and infertility specialists at the day-long virtual summit, organized on the World IVF Day and supported by BSVL, concurred that better diagnostics, affordable prices, and setting realistic expectations can shred the myth of infertility treatment being the privy to the rich. Eminent IVF experts Dr. Firuza Parikh, Director, Assisted Reproduction and Genetics, Jaslok Hospital and Research Centre, Mumbai, Dr. Hrishikesh Pai, Medical Director, Bloom IVF, Mumbai, Dr. Prakash Trivedi, President of Indian Society for Assisted Reproduction (ISAR), Dr. Jaideep Malhotra, Immediate Past President, ISAR, and Director, Rainbow IVF, and Dr. Neena Malhotra, Professor, ART Centre, Department of Obstetrics and Gynaecology, All India Institute of Medical Sciences, New Delhi as well as policymakers and legal experts attended the summit.  Infertility affects almost 27.5 million couples in India and the country is fast becoming a trusted destination for couples from abroad to get treated for fertility issues. However, the COVID-19-induced pandemic has halted infertility treatment globally as well as in India and may have dashed the last hope to have a baby for many couples. ]]> <![CDATA[PPS announces integrated development program with Bolt for ISAC]]> https://biospectrumindia.com/news/95/16947/pps-announces-integrated-development-program-with-bolt-for-isac.html https://biospectrumindia.com/news/95/16947/pps-announces-integrated-development-program-with-bolt-for-isac.html Thu, 30 Jul 2020 17:15:00 +0530 Mumbai based Piramal Pharma Solutions (PPS), leading contract development and manufacturing company (CDMO), recently announced that Bolt Biotherapeutics (Bolt) has both the immunostimulatory antibody conjugate (ISAC) drug substance BDC-1001 and the drug product for the ongoing phase 1/2 clinical trial in cancer patients. The PPS team applies its integrated drug development model to Bolt's BDC-1001 to treat patients with HER2-expressed solid tumors. The program includes formulation development and ISAC development and manufacturing at PPS's Grangemouth site in the United Kingdom. The drug substance is then filled into lyophilized, sterile vials at the Lexington PPS site in Kentucky, USA. This seamless integration across two PPS locations, which shortens delivery times and speeds up distribution to clinics, is an example of the patient-oriented philosophy of PPS. The first cycle from the manufacture of a drug substance to the manufacture of the drug itself has been successfully completed through the PPS integrated program. Further cycles are ongoing, as are further developments that will benefit future indications and new clinical programs. ]]> <![CDATA[Cadila Pharma unveils Ritucad for blood cancer treatment]]> https://biospectrumindia.com/news/95/16938/cadila-pharma-unveils-ritucad-for-blood-cancer-treatment.html https://biospectrumindia.com/news/95/16938/cadila-pharma-unveils-ritucad-for-blood-cancer-treatment.html Thu, 30 Jul 2020 07:10:00 +0530 Ahmedabad based Cadila Pharmaceuticals Limited recently announced the launch of biosimilar Rituximab for India market. Biosimilar Rituximab is used for treatment of blood cancer and rheumatoid arthritis, and will be launched under the brand name Ritucad™. Ritucad™ is used in the treatment of Non-Hodgkin’s lymphoma (a type of blood related cancer). Every year there are more than 28,000 new cases of Lymphoma in India. Cadila has been committed towards providing high quality and affordable care for the patients. Ritucad™ is the second biosimilar in a series of biosimilar products planned by the organization this year and will be made available in a single dose vial of two strengths, 100 mg and 500mg. Cadila Pharmaceuticals Ltd is working towards strengthening its biosimilar portfolio and is investing into launching more biosimilar products in the future. The pharma giant has recently launched Bevasizumab biosimilar which is a humanized monoclonal antibody, recommended in multiple indications under the brand name Bevaro™. ]]> <![CDATA[Hetero launches Favivir in India to treat mild to moderate COVID-19 cases]]> https://biospectrumindia.com/news/95/16934/hetero-launches-favivir-in-india-to-treat-mild-to-moderate-covid-19-cases.html https://biospectrumindia.com/news/95/16934/hetero-launches-favivir-in-india-to-treat-mild-to-moderate-covid-19-cases.html Wed, 29 Jul 2020 13:00:00 +0530 Hyderabad based Hetero, one of India’s leading generic pharmaceutical companies and the world’s largest producer of antiretroviral drugs, has announced the launch of generic Favipiravir in India under the brand name ‘Favivir.’ Hetero has been granted the manufacturing and marketing approval for Favipiravir from the Drug Controller General of India (DCGI). Favivir is the second drug developed by Hetero after Covifor (Remdesivir) used in the treatment of Covid-19. It is an oral antiviral medication that has demonstrated positive clinical outcomes. Favivir improves treatment accessibility to a significant amount of Covid 19 patient population, which usually sustains mild to moderate symptoms. Hetero’s Favivir is priced at Rs. 59 per tablet and is marketed and distributed by Hetero Healthcare Limited. The product is available from today at all retail medical outlets and hospital pharmacies across the country and will be sold only on prescription. Backed by strong vertical integration capabilities, the drug is being manufactured at our world-class formulation facility in India, which has been approved by stringent global regulatory authorities such as USFDA and the EU, among others. ]]> <![CDATA[Allmpus expedites OTC healthcare products in post-COVID world]]> https://biospectrumindia.com/news/95/16927/allmpus-expedites-otc-healthcare-products-in-post-covid-world.html https://biospectrumindia.com/news/95/16927/allmpus-expedites-otc-healthcare-products-in-post-covid-world.html Wed, 29 Jul 2020 08:20:00 +0530 Mumbai based Allmpus Laboratories, one of India's leading research-based pharmaceutical enterprises, eyes to enter the OTC market in the post-COVID world. The move will steer the enterprise into the new market, fulfilling the rising demand for OTC products amongst Indian consumers. The OTC drug market in India stood at $6.38 billion in 2019, with an estimated CAGR of 19.4%. By 2024 the market is expected to reach 15.48 billion. With the sentiment of self-sufficiency running strong in the country and anticipated positive growth may happen sooner than expected. Factors like unhealthy dietary habits, lifestyle diseases, rising fear of COVID-19, and the unavoidable need to build immunity have contributed to the spiraling demand for OTC products in India. Moreover, behavioral changes in society with more health-conscious consumers and their changing attitudes towards self-medication also act as catalysts in the increasing demand. India pharmaceutical companies are inclining towards OTC drug production in the coming future. Allmpus Laboratories carry out extensive R & D to come up with new medical essential products while mustering production strength to make them available on a large scale during the post-pandemic time. ]]> <![CDATA[Jubilant Biosys announces merger with Jubilant Chemsys]]> https://biospectrumindia.com/news/95/16929/jubilant-biosys-announces-merger-with-jubilant-chemsys.html https://biospectrumindia.com/news/95/16929/jubilant-biosys-announces-merger-with-jubilant-chemsys.html Wed, 29 Jul 2020 06:10:00 +0530 Bengaluru based Jubilant Biosys Limited, a wholly owned subsidiary of Jubilant Life Sciences Limited, has announced completion of the merger with its sister company Jubilant Chemsys Limited, based in Noida, India. The combined entities will now operate as Jubilant Biosys Limited. The merger will simplify operations and provide customers with a single brand access for a wide range of discovery, IND and PR&D and GMP development services. Biosys had earlier announced significant investment in building new state-of-the-art research facilities in Greater Noida and in Bengaluru, India to cater to increasing customer demand for its functional services (medicinal & synthetic chemistry, structural biology, DMPK, Biology & GMP scale-up) and notably integrated drug discovery services. Marcel Velterop, President- Jubilant Biosys Limited and CDMO, said: "We are delighted to make this merger happen and focus our investments for growth to expand both the chemistry as well as integrated drug discovery capabilities. It provides clarity to customers and enables us to better deliver on our '4D' promise of accelerating the discovery process through increased digitization of our operations and information flow." ]]> <![CDATA[Healthcare engagement platform Medimojo joins hands with THB]]> https://biospectrumindia.com/news/95/16928/healthcare-engagement-platform-medimojo-joins-hands-with-thb.html https://biospectrumindia.com/news/95/16928/healthcare-engagement-platform-medimojo-joins-hands-with-thb.html Tue, 28 Jul 2020 17:30:00 +0530 Delhi-based personalized patient engagement platform, Medimojo has recently joined hands with THB. Founders of Medimojo – Dr. Shikha Suman and Vikas Ranjan – as well as the entire team at Medimojo is now on board with THB. With this development, THB aims to further strengthen its product suite for healthcare providers, and accelerate presence across India. Medimojo offers patient engagement and advocacy solutions for diagnostic labs and hospitals. The company claims to have deployed its solution for over 5mn patients across the country. THB runs S. Asia’s largest clinical intelligence platform, enabling real-time processing of more than 50mn clinical records. THB offers clinical decision support and real-world evidence solutions for a wide range of clients across the healthcare ecosystem. THB has raised funds from Healthquad, Blume Ventures, Dream Incubator, HealthXCapital, among others, and is actively expanding its presence across providers, pharma, and insurance verticals across S. Asia, GCC and SE Asia. ]]> <![CDATA["Ph III results for BCG vaccine should come before 2020 ends"- Adar Poonawalla]]> https://biospectrumindia.com/news/95/16920/ph-iii-results-for-bcg-vaccine-should-come-before-2020-ends-adar-poonawalla.html https://biospectrumindia.com/news/95/16920/ph-iii-results-for-bcg-vaccine-should-come-before-2020-ends-adar-poonawalla.html Tue, 28 Jul 2020 07:15:00 +0530 Pune based Serum Institute of India Pvt Ltd (SIIPL) has been supported under Department of Biotechnology’s National Biopharma Mission for conduct of a multisite randomized double-blinded placebo-controlled phase III clinical trial ofa recombinant BCG vaccine candidate, VPM1002. The objective of this trial is to evaluate the ability of VPM1002 in reducing infection incidence and severe disease outcomes of COVID-19 among high-risk persons of advanced age or co-morbidities and high-exposure healthcare workers (HCWs). BCG vaccine is administered routinely to all newborn babies as a part of the National childhood immunization programme to prevent tuberculosis (TB), an infection caused by bacteria that mainly affects the lungs. It has beneficial heterologous effects and proven antiviral and immune modulatory properties that protect against infectious diseases through induction of trained innate immunity and heterologous adaptive immunity. About 6,000 health workers and high-risk individuals including those in close contact of COVID patients have been enrolled in a clinical trial to determine if the recombinant Bacillus Calmette-Guerian (rBCG) can boost immunity to fight against the virus. Dr Renu Swarup, Secretary, DBT and Chairperson, BIRAC speaking on the subject said that “BCG vaccine is a proven platform and utilizing its off-target effects for diseases other than TB is a very pragmatic approach to take. The trial began in May’ 2020 and has completed enrolment of 6000 subjects in almost 40 hospitals across the country. This is an important milestone, in the quest for preventing the disease and we look forward to the results of this important trial”.  “We are delighted to partner with DBT-BIRAC for this study and look forward to the positive results of the trial, which should be available before the end of this year”, said Adar Poonawalla, CEO, Serum Institute of India (SII). ]]> <![CDATA[Abbott & 1mg bring CGM solutions closer to Indian homes]]> https://biospectrumindia.com/news/95/16918/abbott-1mg-bring-cgm-solutions-closer-to-indian-homes.html https://biospectrumindia.com/news/95/16918/abbott-1mg-bring-cgm-solutions-closer-to-indian-homes.html Tue, 28 Jul 2020 06:10:00 +0530 In a move to expand access and empower Indian patients to take charge of their health, American multinational medical devices and healthcare company Abbott and Gurugram based online pharmacy and healthcare platform, 1mg has recently announced their collaboration to make Abbott’s continuous glucose monitoring (CGM) products available online, including its professional flash glucose monitoring system, FreeStyle ® Libre Pro. Patients in India can upload a healthcare practitioner’s prescription and purchase the product online on 1mg. An on-site phlebotomy service will be provided at the patient’s home with a phlebotomist helping the patient administer the sensor and take readings of the data after 14 days, enabling them to start using the device. Abbott′s FreeStyle Libre Pro consists of a small, round sensor — slightly larger than a 10-rupee coin. A phlebotomist applies the discreet, water-resistant 1, and disposable sensor on the back of the upper arm of a patient. The sensor is held in place with a self-adhesive pad and remains on the back of the upper arm for up to 14 days, requiring no patient interaction with the sensor. ]]> <![CDATA[Brinton Pharma gets approval to launch Favipiravir in India]]> https://biospectrumindia.com/news/95/16905/brinton-pharma-gets-approval-to-launch-favipiravir-in-india.html https://biospectrumindia.com/news/95/16905/brinton-pharma-gets-approval-to-launch-favipiravir-in-india.html Mon, 27 Jul 2020 06:10:00 +0530 Pune based Brinton Pharmaceuticals, one of the leading pharmaceutical companies in India has recently received approval from Drugs Controller General of India (DCGI) to market Favipiravir under the brand name Faviton. It will be available in 200mg tablets. Brinton is one of the top few companies to market this drug in India and it will also be exporting Faviton globally. Emerging favorable global clinical evidence suggests, Favipiravir is an effective treatment option in the management of mild to moderate COVID 19. As this is an orally administered medication, it is more convenient compared to intravenously administered medicines. In India, Favipiravir was first approved by the regulatory authorities in June’20 under emergency use authorization to treat COVID 19 patients. Mr. RahulKumar Darda, CMD commented, “As a socially responsible company, we always wanted to launch an “evidence-based cure” to combat COVID 19. Our strategic intent will be to improve the access through our strong distribution network that will help make Faviton available across all COVID treatment centers and our MRP is Rs.59 per tab”. Faviton will be available in a strip of 10 tablets and 50 tablets in a box, which is a rational pack for the treatment. Faviton is indicated in the treatment of patients with mild to moderate COVID-19 disease and comes with 90 days shelf-life. ]]> <![CDATA[Linc brings Pentonic Covid-19 killer]]> https://biospectrumindia.com/news/95/16910/linc-brings-pentonic-covid-19-killer.html https://biospectrumindia.com/news/95/16910/linc-brings-pentonic-covid-19-killer.html Mon, 27 Jul 2020 06:10:00 +0530 As the world looks for nifty ways to protect themselves in the battle against the pandemic, Linc Pen and Plastics Limited, a stationery manufacturing company based in Kolkata, has announced the launch of a gizmo of the future – the Pentonic Covid-19 Killer. An infinite quest for research and innovation has always set Linc’s Pentonic range apart as a trailblazer amongst its kind, and the company has risen to meet the need of the hour. The ground-breaking instrument is a finger-free touch device designed to keep one safe in instances of unavoidable physical contact, primed to be the most technologically advanced product from the house of Linc! The Pentonic Covid-19 Killer is a pocket-sized, retractable, sterilizing marker, to be used on surfaces while one is on the move, like elevator buttons, doorbells, card swipe machines, ATM buttons, vending machines, switches and innumerable other areas where physical contact might have otherwise been inevitable! Measuring 122mm in height and 20mm in width, it functions as an extension of one’s index finger, making it incredibly easy to carry and use anywhere. With this latest addition to the Pentonic range which is always driven by design, Linc has brought the future of safety to one’s fingertips! Reducing contact and contamination is only one thing under the arsenal of this gadget; the 70% ethanol-based ink of the Pentonic Covid-19 Killer also sterilizes the surface it touches, combating germs out of one’s way! The neat marker-like design enables an easy one-handed use, making it an indispensable go-to device while stepping out of home. The sleek, compact tool has a smooth, white, plastic body, operated with an easy push button. A refillable cartridge ensures that time never runs out on this mighty weapon. With the replaceable ethanol-based ink refill, it is a convenient and cost-effective product perfect for students, office goers and any and everyone. This futuristic innovation from one of the most trusted and valued writing instrument manufacturers of the country is crafted to pave the way for innovators in the field of safety and hygiene. The Pentonic Covid-19 Killer will be available at retail stores, stationery shops and pharmaceutical chains all across key cities like Kolkata, Delhi, Gurgaon, Jaipur, Mumbai, Pune,Ahmedabad, Hyderabad, Chennai, Bangalore and Trivandrum by August 1st week. This technological marvel can also be purchased on major e-commerce platforms like Amazon and Flipkart by 4th week of July, 2020 onwards. ]]> <![CDATA[Knam Marketing launches novel antimicrobial copper film]]> https://biospectrumindia.com/news/95/16913/knam-marketing-launches-novel-antimicrobial-copper-film.html https://biospectrumindia.com/news/95/16913/knam-marketing-launches-novel-antimicrobial-copper-film.html Fri, 24 Jul 2020 19:10:00 +0530 Noida based Knam Marketing, an international trader providing the best recyclables from all over the world has recently launched an SGS certified anti-microbial copper film. The protective film can act as a shield for surfaces from getting contaminated by bacterial-attacks. Approved by NABL India and the US Environmental Protection Agency (USEPA), the 100% Korean product is ideal for preventing toxic viruses and bacteria from growing and transmitting to humans. It takes only 5 minutes to detect and deactivate almost 99.9% of the viruses. As these copper films adhesive sheets are low in maintenance, they can last for 2 years. The anti-microbial and anti-inflammatory copper film is self-sterilizing, which means it can decontaminate itself. How antimicrobial copper film works against the viruses: The bacteria identify the copper ion as a nutrient on the surface and absorbs it into its cell. The absorbed copper ion then penetrates the cell membrane of bacteria, leading to water and essential nutrients' loss from the cell. The absorbed copper ion sucks out all the other essential-for-living elements from the cell, like active and reactive oxygen species. With the loss of water, oxygen, and nutrients, the metabolic and respiratory activity of bacteria stops forcing it to die. Some significant features that make the antimicrobial copper indispensable are; the strong anti-microbial properties of copper, which remain active until the film lasts; the film can be easily used to cover any desired surface and it will start exterminating the virus; and, it's natural antibiotic properties make it harmless for humans and the environment. ]]> <![CDATA[Cipla receives approval for Ciplenza to treat mild to moderate COVID-19]]> https://biospectrumindia.com/news/95/16909/cipla-receives-approval-for-ciplenza-to-treat-mild-to-moderate-covid-19.html https://biospectrumindia.com/news/95/16909/cipla-receives-approval-for-ciplenza-to-treat-mild-to-moderate-covid-19.html Fri, 24 Jul 2020 17:00:00 +0530 Mumbai based Cipla Limited has announced that it has been granted regulatory approval by the Drug Controller General of India (DCGI) for the launch of Favipiravir in the country under the brand name Ciplenza.  The accelerated approval for manufacturing and marketing of the drug is aimed at meeting the urgent and unmet medical need for COVID-19 treatment options in the country through restricted emergency use. As part of its efforts to enable speedy access to cater to the demand, Cipla will commercially launch Ciplenza in the first week of August priced at Rs 68 per tablet. To ensure fair and equitable distribution of the drug, supplies will be undertaken predominantly through hospital channels and via open channels, prioritised for regions with a high burden of COVID-19 cases.  The drug has been jointly developed by Cipla and CSIR-Indian Institute of Chemical Technology (IICT). As part of this partnership, CSIR-IICT has successfully developed a convenient and cost-effective synthetic process for Favipiravir. The entire process and Active Pharmaceutical Ingredient (API) of the drug has been transferred to Cipla to manufacture and market the drug at scale. Favipiravir is an off patent, oral anti-viral drug that has been shown to hasten clinical recovery in COVID -19 patients with mild to moderate symptoms.   ]]> <![CDATA[APAC Biotech gets patent for immunotherapy product]]> https://biospectrumindia.com/news/95/16908/apac-biotech-gets-patent-for-immunotherapy-product.html https://biospectrumindia.com/news/95/16908/apac-biotech-gets-patent-for-immunotherapy-product.html Fri, 24 Jul 2020 14:20:00 +0530 Delhi based APAC Biotech, a biotechnology company involved in extensive research on personalized immunotherapy using dendritic cells for over a decade, was finally granted Indian patent, entitled "Composition and method for producing activated dendritic cells.” The company has previously conducted trials and received the approval by the Drug Controller General of India in 2017 for its product APCEDEN. Being completely autologous in nature, it has been successfully infused to patients with an excellent safety profile and efficacy. APAC Biotech's present invention provides a composition comprising of a population of activated dendritic cells tutored in the lab to produce immunogens useful in the treatment of cancer. The invention also provides a method for producing a population of activated dendritic cells specific to a patient's whole tumor protein. Most significantly, the procedures used to manufacture dendritic cells replicate the natural environment of the human host very closely. APAC Biotech's new product is named LTR-MEMVAXRALEUCEL, which is a unique, advanced and never-been-used-before technology based on homogenous loading of the whole tumor amplified mRNA and whole tumor protein, specifically designed for Glioblastoma and Pancreatic Ductal Adenocarcinoma for which clinical trial is awaited, and APAC Biotech is in talks with various eminent hospitals and principal investigators to initiate the trial in India very soon. ]]> <![CDATA[Loyal Textile Mills unveils first reusable PPE]]> https://biospectrumindia.com/news/95/16899/loyal-textile-mills-unveils-first-reusable-ppe.html https://biospectrumindia.com/news/95/16899/loyal-textile-mills-unveils-first-reusable-ppe.html Fri, 24 Jul 2020 07:10:00 +0530 Chennai based Loyal Textile Mills Limited has launched Viral Shield, a line of COVID-19 Anti-Viral, Reusable Personal Protective Equipment (PPE), Masks and Protective Fashion Wear Range. The series has been launched in collaboration with Reliance Industries India and HeiQ from Switzerland. This PPE emerges as the World’s first Reusable PPE that has passed the Viral Penetration Test, nad Synthetic Blood penetration test. R|ElanTM FeelFresh (from Reliance Industries India) fibre used in manufacturing this fabric is inherently anti-microbial that inhibits any viral* or bacterial growth. The fabric is then specially treated with “HeiQ Viroblock” a latest technology innovation from Switzerland, proven to have astounding Anti-Viral efficacy of 99.99% against Coronavirus SARS-CoV-2 (COVID-19).  Triple shield protection R|Elan™ FeelFresh fabric which is inherently anti-microbial inhibiting bacterial and viral* growth HeiQ Viroblock anti-viral treatment on the fabric Viral barrier PU film lamination for the first time in the world. Loyal Textile Mills Limited has engineered the fabric with a Viral Barrier PU film lamination from Taiwan that adds up as another powerful protective later. ]]> <![CDATA[ Oorja launches VirusKiller to sterilize air]]> https://biospectrumindia.com/news/95/16898/-oorja-launches-viruskiller-to-sterilize-air.html https://biospectrumindia.com/news/95/16898/-oorja-launches-viruskiller-to-sterilize-air.html Thu, 23 Jul 2020 16:30:00 +0530 Hyderabad based company Oorja Cleantech LLP, a pioneer in providing cleantech solutions, has launched VirusKiller in India that neutralizes certain viruses and bacteria including coronavirus SARS CoV1, in a single air pass. Single-air pass kill rates are instrumental in minimizing the risk of cross-contamination. World Health Organisation (WHO) also recently confirmed that viruses can be transmitted through aerosols combined with droplet transmission in public settings like in very specific conditions, crowded, closed, poorly ventilated settings. VirusKiller has been tested on the coronavirus (SARS CoV1) in the Institute of Medical Sciences, School of Medicine National Kangwon University, South Korea. The test confirms that the air is completely sterilized, and no virus survived when it was passed through the machine. Oorja is importing the air sterilizers from South Korea-based INBair and Radic8. VirusKiller is also being tested in a lab in India for 15 different viruses & bacteria including the Covid19 virus. VirusKiller uses a two-stage process of filtration followed by sterilization. Oorja is launching three types of air sterilizers in India: Hextio, VK- 401, and VK-102 designed for both personal and commercial use.  VK 102 is a high-end air sterilizer that provides complete negative pressure sterilization, which ensures that the contaminants from one room do not escape to another. All the three air sterilizers require a simple installation process and maintenance and are available across India. ]]> <![CDATA[LifeCell makes landmark stride in stem cell treatments ]]> https://biospectrumindia.com/news/95/16893/lifecell-makes-landmark-stride-in-stem-cell-treatments-.html https://biospectrumindia.com/news/95/16893/lifecell-makes-landmark-stride-in-stem-cell-treatments-.html Thu, 23 Jul 2020 12:20:00 +0530 Chennai based LifeCell, India's first and largest stem cell bank, has recently announced its remarkable surge in its community banking inventory by clocking over 50,000 consented and qualified donor stem cell units.  This inventory will help in overcoming the search burden for finding matching stem cells when needed, by enabling a 97% probability of finding HLA matching stem cell unit on a match from the community inventory.  Stem cell transplantation is being considered as probably the only treatment option for a wide array of blood disorders. Hence this milestone further strengthens LifeCell’s community banking as India’s largest preserved inventory of cord blood stem cells that act as a closed donor group for the families that have preserved their baby's umbilical cord blood stem cells at birth. In 2013, LifeCell got an investment of Rs 35 crore from Helion Venture Partners, an India-focused venture fund, to support its plans of increasing market penetration of stem cell banking in India. With a turnover of Rs 126 crore (noted in the year 2017), LifeCell has a 60% share in the Indian market.  Reports have indicated that the stem cell therapy or global regenerative medicine market was worth $28 billion in 2018 and will grow to over $81 billion by 2023, with a compound annual growth rate (CAGR) of 23.3% during this period.  To date India has taken several initiatives to promote developments in this field. Pertaining to stem cells, the Department of Biotechnology (DBT) has invested in basic stem cell research since 2001, and currently, over 40 institutions, hospitals and industries in our country are actively involved in the research. The Institute for Stem Cell Biology and Regenerative Medicine (inStem) was also opened in the year 2009, which is an independent research institute in this field.   ]]> <![CDATA[Cadila Pharma expands oncology portfolio with Bevaro]]> https://biospectrumindia.com/news/95/16887/cadila-pharma-expands-oncology-portfolio-with-bevaro.html https://biospectrumindia.com/news/95/16887/cadila-pharma-expands-oncology-portfolio-with-bevaro.html Thu, 23 Jul 2020 04:00:00 +0530 Ahmedabad-based Cadila Pharmaceuticals Limited recently announced the launch of Bevasizumab biosimilar for the domestic market. Bevacizumab biosimilar is a humanized monoclonal antibody, recommended in multiple indications and will be launched under the brand name Bevaro™. Bevasizumab is used in the treatment of multiple cancers which are common in India like Ovarian Cancer, Glioblastoma Multiforme (a type of Brain cancer), Colorectal Cancer, Breast Cancer, Lung Cancer, Cervical Cancer and Kidney Cancer. In a commitment to further strengthen the oncology portfolio Cadila’s Bevaro™ will be made available in a single-dose vial of two strengths, 100 mg, and 400mg. The pharma giant has always been focused on making sure high quality, affordable, and life-saving treatments are within the reach of patients. Biosimilar products like Bevaro™ are safe and more efficacious compared to conventional treatment medicines. Cadila plans to launch multiple biosimilar products this year for the Indian Market. ]]> <![CDATA[Mylan receives DCGI approval for TB drug pretomanid ]]> https://biospectrumindia.com/news/95/16886/mylan-receives-dcgi-approval-for-tb-drug-pretomanid-.html https://biospectrumindia.com/news/95/16886/mylan-receives-dcgi-approval-for-tb-drug-pretomanid-.html Wed, 22 Jul 2020 16:30:00 +0530 Mylan, a global pharmaceutical company recently announced that the Drug Controller General of India (DCGI) has approved the anti-tuberculosis drug pretomanid for conditional access under the National Tuberculosis Elimination Program (NTEP) program, making India the second country in the world to provide regulatory approval for this product. Pretomanid has been approved as part of a three-drug, a six-month all-oral regimen consisting of bedaquiline, pretomanid, and linezolid, collectively referred to as “BPaL” for the treatment of adult patients with pulmonary extensively drug-resistant TB (XDR-TB), treatment intolerant or non-responsive multidrug-resistant TB (MDR-TB). Through the approval from DCGI, Mylan will initially make it's pretomanid available in India through a donation of 400 treatment courses to the Government’s National Tuberculosis Elimination Program (NTEP), which provides free, high-quality anti-tubercular drugs and care across the country to ensure that the treatment is accessible to patients who need it the most. The company also will provide commercial access to NTEP of US $364 for a six-month treatment course and will be manufacturing its pretomanid product both for domestic and global supply in India.   Mylan President Rajiv Malik said, “Mylan offers one of the world’s leading infectious disease portfolios and the approval of pretomanid in India further supports our global commitment to transform the TB treatment landscape through greater access and affordability. It also demonstrates the power of innovative partnerships, like the one we’re proud to have with TB Alliance, in expanding the availability of new medicines for patients. To date, Mylan and TB Alliance have secured approvals for pretomanid in two countries. As important, and thanks to DCGI’s continued focus on the treatment of TB even amidst the evolving COVID-19 pandemic, we achieved the approval in India with record speed. We look forward to continuing our journey to ensure the availability of treatment for those who most need it in high-burden countries globally.” ]]> <![CDATA[Richcore LifeSciences expands manufacturing capability]]> https://biospectrumindia.com/news/95/16879/richcore-lifesciences-expands-manufacturing-capability.html https://biospectrumindia.com/news/95/16879/richcore-lifesciences-expands-manufacturing-capability.html Wed, 22 Jul 2020 07:15:00 +0530 Bengaluru based biotech company, Richcore Life Sciences is expanding its manufacturing capability by building a second recombinant protein manufacturing facility, R2 at Vasanthanarasapura,Tumkur a tier two city in Karnataka. The facility will house a state-of-the-art 180 thousand Litre fermentation capability which can produce multiple recombinant biotechnology products for Biopharma, Cell culture and Food industries.  This new facility will help Richcore multiply its manufacturing capability 20 times by January 2021 and is the first of the many large scale global quality Bio-Manufacturing sites Richcore plans to establish in the next few years. The foundation stone for the Tumakuru facility was laid by the Deputy Chief Minister of Karnataka and  IT / BT, Sicence & Technology Minister,  Dr C.N Ashwathnarayan on June 15th 2020. While congratulating the Richcore team, he said, that it is “Great to see Karnataka’s BT sector continue expanding beyond the city limits of Bengaluru into innovative tier two cities” and appreciated Richcore’s “Make in India” Initiative. Richcore’s expansion will go a long way in augmenting indigenous manufacturing of biomedical resources and strengthening India’s domestic supply chain, especially important in the backdrop of the Government’s call for local sourcing and local manufacturing.   Established in 2005 and currently located in Jigani, Bengaluru, Richcore’s USP is Non-Animal Origin ‘green’ recombinant protein technology. Their products enable global biologics, vaccine and cell culture companies, achieve higher levels of drug safety compliance by replacing viral-contamination prone, animal-derived components with their recombinant Non-animal Origin (NAO) alternatives. For example, their recombinant trypsin (rcTrypsin) has enabled production of more than 10 billion doses of safer insulin shots till date. Moreover optimized cGMP development & cGMP certified manufacturing platforms enable them to adhere to international quality control and safety standards. ]]> <![CDATA[Jubilant launches JUBI-R for COVID-19 treatment]]> https://biospectrumindia.com/news/95/16880/jubilant-launches-jubi-r-for-covid-19-treatment.html https://biospectrumindia.com/news/95/16880/jubilant-launches-jubi-r-for-covid-19-treatment.html Wed, 22 Jul 2020 07:15:00 +0530 Noida headquartered Jubilant Life Sciences Limited, an integrated global pharmaceutical and life sciences company, is pleased to announce that its subsidiary, Jubilant Generics Limited, has received approval from the Drug Controller General of India (DCGI) to manufacture and market the investigational antiviral drug remdesivir for 100 mg/vial (lyophilized injection) for restricted emergency use in India for the treatment of severe COVID-19. Jubilant’s remdesivir product will be marketed under the brand name ‘JUBI-R’ in India and will be made available in 100 mg vials (injectable). It would be administered intravenously in a hospital setting under the supervision of a medical practitioner. The Company will distribute the drug in the Indian market through its distribution network and will be available by the first week of August 2020. In May 2020, Jubilant entered into a non-exclusive Licensing Agreement with Gilead Sciences, Inc. (NASDAQ: GILD) that granted it the right to register, manufacture and sell Gilead’s investigational drug remdesivir in 127 countries including India. Remdesivir is the only antiviral drug that has received Emergency Use Authorization (EUA) by the USFDA for treatment of suspected or laboratory confirmed COVID-19 in adults and children hospitalized with severe disease. “We are very pleased to launch ‘JUBI-R’, a drug with potential to save lives of people who have contracted COVID-19,” stated Mr. Shyam S. Bhartia, Chairman and Mr. Hari S. Bhartia, Co-Chairman & Managing Director, Jubilant Life Sciences Limited.  “At Jubilant, we are focused on quickly making this drug available in India in required quantities and at affordable prices. This milestone underscores our continued commitment to provide leading healthcare solutions as well as demonstrates our ability to leverage our broad capabilities to deliver important new medicines.” ]]> <![CDATA[Biocon Biologics, Voluntis to bring digital therapeutics for insulins]]> https://biospectrumindia.com/news/95/16878/biocon-biologics-voluntis-to-bring-digital-therapeutics-for-insulins.html https://biospectrumindia.com/news/95/16878/biocon-biologics-voluntis-to-bring-digital-therapeutics-for-insulins.html Tue, 21 Jul 2020 14:00:00 +0530 Biocon Biologics India Limited, a fully integrated ‘pure play’ biosimilars company,  a subsidiary of Biocon Ltd., and Paris based Voluntis, a leader in digital therapeutics, have announced a global collaboration agreement between Biocon Biologics’ subsidiary Biocon Sdn. Bhd., Malaysia and Voluntis to develop and distribute innovative digital therapeutics supporting people with diabetes on biologics therapy. The licensing agreement will make Biocon Biologics one of the first insulins companies to offer a U.S. Food and Drug Administration-cleared and CE-marked, highly validated digital therapeutic product, Insulia®, to Type 2 diabetes patients, across several markets in the world. Insulia® provides automated insulin dose recommendations enabling people with diabetes to self-manage their condition and healthcare teams to remotely monitor progress. Insulia® is the first digital therapeutic with regulatory clearance to provide automated titration recommendations for all types of basal insulins. The demand for at-home treatment and telemedicine solutions is dramatically increasing around the world, with select healthcare systems offering reimbursement for patients eligible for digital therapeutic solutions. Once developed, the Insulia® digital companion will be offered to people with Type 2 diabetes using Biocon Biologics’ insulins, in key global markets. Going forward, by extending the Insulia® platform to its complete range of insulin products, including Recombinant Human Insulin, Insulin Glargine and Insulin Aspart, Biocon Biologics will create a comprehensive digital therapeutics portfolio for patients. ]]> <![CDATA[Mylan initiates supply of DESREM for COVID-19 treatment]]> https://biospectrumindia.com/news/95/16872/mylan-initiates-supply-of-desrem-for-covid-19-treatment.html https://biospectrumindia.com/news/95/16872/mylan-initiates-supply-of-desrem-for-covid-19-treatment.html Mon, 20 Jul 2020 17:00:00 +0530 Mylan, a global pharmaceutical company, has announced the commercial launch of its Remdesivir under the brand name DESREMTM in India to address urgent, unmet needs amid the evolving coronavirus 2019 (COVID-19) pandemic. The drug is approved for the treatment of suspected or laboratory confirmed incidences of COVID-19 in adults and children hospitalized with severe presentations of the disease. The company also launched a 24/7 helpline where patients and healthcare practitioners can access information about Mylan’s Remdesivir and its availability. Mylan released the first batch of its generic Remdesivir (DESREMTM) and will continue to increase its supply across the country in the wake of the rising demand for the drug. Patients and healthcare practitioners can access information about the availability of DESREMTM in India through Mylan’s 24/7 national helpline number, +91.78299.80066. Mylan will manufacture DESREMTM in its state-of-the-art injectable facility in Bangalore, which will work to service the demand in India and other export markets where Mylan has received a license from Gilead for the commercialization of Remdesivir. The previously announced agreement between Mylan and Gilead is part of a long-standing history between the two organizations to tackle key public health issues in India and around the world, beginning with expanding access to high quality, affordable HIV/AIDS antiretrovirals and now extending its partnership to include COVID-19 treatments. President, India and Emerging Markets, Rakesh Bamzai said: “In the wake of increasing cases of COVID-19 across India, Mylan remains committed to continue its efforts in the fight against the pandemic. With the launch of DESREMTM and our national 24/7 COVID-19 helpline, we aim to enhance access to this critical medicine, used for treating adults and children with severe presentations of Covid-19. At Mylan, we believe we have a responsibility to help make the world a better place and the entire team at Mylan has stepped up in this time of need to serve patients and deliver better health for a better world.” ]]> <![CDATA[V B Pharma working on plasma-based treatment for COVID-19 patients]]> https://biospectrumindia.com/news/95/16864/v-b-pharma-working-on-plasma-based-treatment-for-covid-19-patients.html https://biospectrumindia.com/news/95/16864/v-b-pharma-working-on-plasma-based-treatment-for-covid-19-patients.html Mon, 20 Jul 2020 07:15:00 +0530 While India's hopes for an early vaccine against COVID-19 got delayed by a year, there's another beacon for cost-effective COVID treatment. A Karnataka based pharma company Vinodbadgu Pharmaceutical Pvt. Ltd. (V B Pharma) specializing in plasma technology has revealed that it is already working on research to synthesise a more effective plasma-based treatment for COVID patients."Since May 2020, we're on a mission to develop a safe, efficient and cost-effective treatment for COVID 19 patients in India", said Prashant Karulkar, director, Vinodbadgu Pharmaceutical Pvt. Ltd. (V B Pharma)."So far, we've evaluated donor plasma from COVID-recovered patients and identified different kinds of COVID strains across India. By our count, this number is 12. Our sample strengths are from Solapur. We've been able to identify specific antigens for the COVID strains from here and the most common antibodies against them", added Karulkar.Dr Vinodkumar Badgu, the managing director, Vinodbadgu Pharmaceutical Pvt. Ltd. (V B Pharma), shares Karulkar's enthusiasm. Sharing some of his observations on the research, Dr Badgu said, "Out of the 12 common COVID-19 strains, we've identified one common antibody which all recovered patients have created within themselves to fight against the virus. In total, we've observed seven kinds of antibodies that these patients hold."What's the next step? "The next step for us is antibody mapping, which usually spans 2-3 months and biopanning. Biopanning is where we will take a strain of the active virus and verify whether these antibodies will eliminate it. Once we're all successful, we will begin coding the winning antibody on a molecular level and recreate it artificially", Dr.Badgu explained.The plasma products company is on the same track as many other international organisations working on plasma-based solutions for COVID-19. The Houston Methodist Hospital in Houston, USA, the Pisa University Hospital, Italy and Sinovac in China are carrying out plasma-based research too. The organisation is also collaborating with Chandigarh-based BioBridge Healthcare Solutions and BioNEST Bioincubator, Punjab University to further its efforts. They're seeking multiple corporate partners and government support for resources, infrastructure and funding to expedite the research. "Right now, we appeal to corporates, industry bodies and the government to help us with funds to carry out this experimental work. We need to augment our infrastructure for equipment, instruments and talented resources. We also need regulatory support to expedite approvals through this process", said Karulkar."We will partner with someone with the facilities for large-scale, lab production of monoclonal (artificially created) antibodies", added Dr Badgu. Plasma treatment has turned into an important treatment for COVID-19, especially in India. Multiple states have approved its use for critically ill patients. Delhi has also begun the first Indian plasma bank and is requesting recovered patients to donate to it. ]]> <![CDATA[Cadila Pharma brings treatment for Vulvovaginal Candidiasis ]]> https://biospectrumindia.com/news/95/16849/cadila-pharma-brings-treatment-for-vulvovaginal-candidiasis-.html https://biospectrumindia.com/news/95/16849/cadila-pharma-brings-treatment-for-vulvovaginal-candidiasis-.html Thu, 16 Jul 2020 07:15:00 +0530 Ahmedabad-based Cadila Pharmaceuticals Limited recently announced the launch of Fenticonazole Nitrate Vaginal Capsules for treatment of Vulvovaginal Candidiasis (VVC) under the brand name Fenticad™. In a commitment to further strengthening the women’s healthcare portfolio Cadila’s Fenticad™ will be 35% more cost effective and a drug of choice. Fenticad™ will be made available in 600 mg tablets. VVC affects up to 75% of women once in their lifetime and severely impacts their quality of life. Almost 37% of women in rural India suffers from VVC in their reproductive age.* Itching (pruritus) and increased vaginal discharge are the most typical symptoms. Other symptoms are variable: soreness and burning, painful sexual intercourse (dyspareunia), or discomfort passing urine (dysuria). These symptoms may also occur in other vaginal infections. A recent dipstick survey revealed that 36% of women went into social isolation when they were having VVC and 33% women admitted that symptoms of VVC impacted their self-confidence (Data on file). Diabetes, pregnancy, inadequate intimate hygiene, unprotected and intense sexual activity, and antibiotic treatment can lead to high risk of developing VVC. During pregnancy, topical anti- fungal treatment (such as fenticonazole, clotrimazole, fluconazole) with the preparation of vaginal capsule or cream is preferred. ]]> <![CDATA[PwC launches study on reviving India's API industry]]> https://biospectrumindia.com/news/95/16852/pwc-launches-study-on-reviving-indias-api-industry.html https://biospectrumindia.com/news/95/16852/pwc-launches-study-on-reviving-indias-api-industry.html Thu, 16 Jul 2020 05:05:00 +0530 PwC has launched a study “Reviving India’s API industry”  to understand the challenges faced by the Indian active pharmaceutical ingredient (API) industry and interventions required to revive the industry. The study by PwC India talks about solving for drug shortages in the wake of supply chain disruptions caused by Covid- 19 where we have analyzed the stocking situation, cost differentials, and reliance on China. The Chinese API industry has a clear inherent advantage because of economies of scale and the support they receive in the form of large-scale manufacturing incentives and state-driven subsidies to promote exports. On the other hand, Indian manufacturers are stressed due to multiple reasons like the stricter implementation of pollution control norms, issues in the interpretation of the Drug Price Control Order (DPCO), no financial incentive, and lack of large-scale mega parks to manufacture bulk drugs. The study goes into specific measures, both short and long term, to revive the industry and reduce the impact of this and future pandemics on our patients and to be able to capitalize on the full potential of its API manufacturing capabilities. As immediate measures, India needs to focus on providing production incentives for critical API/KSMs to encourage investments, providing subsidies in form of cheaper utilities like power and water, faster environment clearances and facilitate alternative sources of imports Sujay Shetty, Partner and Leader Health Industries, PwC India, said, “High dependence on a single source can have a significant adverse impact in emergency situations like Covid-19. With recent changes in API’s prices rising up to 100%, it is time we revive our domestic API industry. While some policy changes may take time, we need to collectively evaluate and strategize for ways to encourage alternative sources.” From a long term perspective, India needs to develop 2–3 large clusters and provide plug-and-play infrastructural support in dedicated zones for manufacturing APIs and encourage industry-academia initiatives.   ]]> <![CDATA[Biophore ramps up Favipiravir production for COVID-19]]> https://biospectrumindia.com/news/95/16846/biophore-ramps-up-favipiravir-production-for-covid-19.html https://biospectrumindia.com/news/95/16846/biophore-ramps-up-favipiravir-production-for-covid-19.html Wed, 15 Jul 2020 06:10:00 +0530 Hyderabad-based Biophore India Pharmaceuticals has announced that it has successfully completed the validation of favipiravir and scaled-up its production. Favipiravir is the active pharmaceutical ingredient (API) that can be used in the finished formulation of an antiviral drug approved by the Drug Controller General of India (DCGI) for mild to moderate cases of Covid-19. Biophore has received the DCGI license to manufacture the API in India and has been cleared for export as well. It has also received approval in Turkey in collaboration with a local Turkish partner. Additionally, the company is in talks with several Indian partners to commercialize the product in India and with Bangladesh and Egypt-based companies for its export. Favipiravir is an antiviral agent that was initially discovered and developed because of its activity against another RNA virus, the influenza virus. Apart from India and Turkey, it has already been approved for use against Covid-19 in Russia and parts of the Middle East and advanced stage trials are currently underway in other parts of the world. Biophore is also awaiting DCGI approval for a favipiravir finished dosage form. Dr. Manik Reddy Pullagurla, Founder and Chief Scientific Officer (CSO) of Biophore, says, “The Covid-19 pandemic has emphasized the need for pharmaceutical companies to step up and develop effective solutions quickly, without compromising on safety. We have ensured that our favipiravir meets the highest standards of quality. Our manufacturing facilities comply with US and EU regulations and we have stringent internal impurity controls and quality checks to ensure that. Meeting favipiravir needs in India is our priority, and we have the capacity to scale up production of favipiravir to meet local requirements, without compromising on our export commitments.”. ]]> <![CDATA[Cipla receives approval for generic version of Shire’s Firazyr®]]> https://biospectrumindia.com/news/95/16840/cipla-receives-approval-for-generic-version-of-shires-firazyr.html https://biospectrumindia.com/news/95/16840/cipla-receives-approval-for-generic-version-of-shires-firazyr.html Tue, 14 Jul 2020 00:00:00 +0530 Cipla Limited has announced that it has received final approval for its Abbreviated New Drug Application (ANDA) for Icatibant Injectable 30mg/3mL from the United States Food and Drug Administration (US FDA). Cipla’s Icatibant Injectable Pre-Filled Syringe 30mg/3mL is AP-rated generic version of Shire’s Firazyr®. Icatibant injection is indicated for the treatment of acute attacks of hereditary angioedema (HAE) in adults 18 years of age and older.  According to IQVIA (IMS Health), Firazyr® and its generic equivalents had US sales of approximately $270M for the 12-month period ending May 2020. ]]> <![CDATA[CREA launches Mad Masks, India’s largest protective Masks E-Store]]> https://biospectrumindia.com/news/95/16843/crea-launches-mad-masks-indias-largest-protective-masks-e-store.html https://biospectrumindia.com/news/95/16843/crea-launches-mad-masks-indias-largest-protective-masks-e-store.html Tue, 14 Jul 2020 00:00:00 +0530 Gurugram based Crea Worldwide,an innovation first manufacturing company that manufactures high end Lifestyle bags, PPE Kits & Coveralls and Tactical gear, has announced the launch of India’s largest Protective Mask Brand, Mad Mask. Mad Masks sells over 1500 SKUs through its online store, www.madmasks.in with a vision to get every citizen to wear a mask to keep themselves safe.  The brand has sold over 1000 masks in beta phase without any marketing and promotions; getting interest from Tier 1 to Tier 3 towns and cities. The masks, meant for daily wear, are washable and reusable thus leading to zero BioMedical waste, another concern that CREA wants to address through Mad Masks. On the launch, Upkar Sharma, Founder & CEO, CREA Worldwide, opined, “Enforcement is not any easy, but when one gives the freedom to express themselves through a creative expression or showcasing their creative vibe, enforcement has a very different viewpoint. At CREA, we want people to be safe by protecting themselves. While we work hard on ensuring the medical standard of masks, we want the youth, the workforce, the parents and their kids to wear masks. While safety is first, we want to bring out the cool quotient of our generations.”  All masks have been created with a certified usage of the fabric and have in them 3 layers as follows: Outer Layer - Breathable fine soft touch polyester Filtration Layer - 25-30 GSM Meltblown Composite Material Inner Layer - Soft and Premium Poly Cotton Anti Microbial finish, Silicon washed fabric. The masks come in six different shapes and three sizes, starting from junior to large starting at INR 299. Mad Masks makes it easier for anyone to pick up a mask of the right shape or pick a design from over 590 designs that are available. The brand is shipping in India currently and aims to be a Market Leader in the Mask Category as a brand this fiscal year. Recently, CREA was awarded a grant of INR 41 Lakhs from Marico Innovation Foundation for ‘Innovate2Beat’ challenge and emerged as front-runner with their ingenious PPE solutions for their hydrophobic and breathable PPE solutions and coveralls.   ]]> <![CDATA[Pankajakasthuri offers ayurvedic hope to COVID-19 patients]]> https://biospectrumindia.com/news/95/16827/pankajakasthuri-offers-ayurvedic-hope-to-covid-19-patients.html https://biospectrumindia.com/news/95/16827/pankajakasthuri-offers-ayurvedic-hope-to-covid-19-patients.html Mon, 13 Jul 2020 08:20:00 +0530 Trivandrum based Pankajakasthuri Herbals India Private Limited (PKHIL) has announced promising interim clinical trial results for ZingiVir-H among patients suffering from COVID-19. Developed by Dr. J. Hareendran Nair, Founder of Pankajakasthuri Herbal Research Foundation, ZingiVir-H is a herbo-mineral drug made of a blend of seven ingredients. With the announcement, the company hopes to reiterate the tremendous potential of Ayurveda as a cost-effective and scalable solution to critical health conditions such as COVID-19. Clinical trials of ZingiVir-H, Pankajakasthuri’s new drug, are underway among 112 patients as an adjunct therapy for the pandemic as well as among 135 additional patients as a stand-alone treatment in a double-blind study. The trials are progressing in 96 of the patients undergoing adjunct therapy. Out of these, the results of 42 patients are being published as an interim report. Among the 42 patients, 22 were treated with ZingiVir-H and 20 were treated with a placebo. It was found that all the 22 patients treated with ZingiVir-H were discharged on the fourth day after real-time Reverse Transcription Polymerase Chain Reaction (RT-PCR). The remaining 20 patients in the control group who received placeboes continued to be COVID-19+ve for 5 to 11 days. ZingiVir-H tablets had obtained the Drugs License of the Government of Kerala and underwent cytotoxicity tests on human cells at the Rajiv Gandhi Center for Biotechnology and CSIR-NIIST at Thiruvananthapuram. After the animal studies were proved to be harmless, the clinical trial registration was obtained from the Clinical Trial Registry of India (CTRI). Thereafter, the drug was placed in Randomized Single Blind Placebo Controlled Multi-Center Clinical Trial as per World Health Organization (WHO)'s ICH-GCP standards at various medical colleges with approvals from respective ethical committees. ]]> <![CDATA[DCGI approves Biocon’s drug Itolizumab to fight COVID-19]]> https://biospectrumindia.com/news/95/16832/dcgi-approves-biocons-drug-itolizumab-to-fight-covid-19.html https://biospectrumindia.com/news/95/16832/dcgi-approves-biocons-drug-itolizumab-to-fight-covid-19.html Mon, 13 Jul 2020 06:10:00 +0530 Biocon Ltd., an innovation-led global biopharmaceuticals company, announced that it has received the Drugs Controller General of India’s (DCGI) approval to market Itolizumab Injection 25mg/5mL solution for emergency use in India for the treatment of cytokine release syndrome (CRS) in moderate to severe  ARDS (acute respiratory distress syndrome) patients due to COVID-19. Itolizumab is the first novel biologic therapy to be approved anywhere in the world for treating patients with moderate to severe COVID-19 complications. Biocon has repurposed Itolizumab, an anti-CD6 IgG1 monoclonal antibody launched in India in 2013 as ALZUMAb for treating chronic plaque psoriasis, for the treatment of CRS in moderate to severe ARDS patients due to COVID-19. Itolizumab will be manufactured and formulated as an intravenous injection at Biocon’s bio-manufacturing facility at Biocon Park, Bengaluru. The approval of Itolizumab, from the DCGI is based on the results from the successful conclusion of a randomized, controlled clinical trial at multiple hospitals in Mumbai and New Delhi.  The study focused on the safety and efficacy of Itolizumab in preventing CRS in moderate to severe ARDS patients due to COVID-19. The primary endpoints for reduction in mortality rate were met and other key secondary endpoints for efficacy and biomarkers were also achieved. ]]> <![CDATA[Cadila Pharma launches Esiloc for treating hyperacidity]]> https://biospectrumindia.com/news/95/16826/cadila-pharma-launches-esiloc-for-treating-hyperacidity.html https://biospectrumindia.com/news/95/16826/cadila-pharma-launches-esiloc-for-treating-hyperacidity.html Fri, 10 Jul 2020 19:00:00 +0530 Ahmedabad-based Cadila Pharmaceuticals Limited recently announced the launch of Esomeprazole tablets for the treatment of Hyperacidity & Drug Induced Gastritis under the brand name Esiloc™. In an endeavor to improve the treatment options available for hyperacidity & drug induced Gastritis, Esiloc™ will be 50% more economical, thus making it a superior yet affordable choice. Esiloc™ will be made available in 20 mg and 40 mg tablets. Esomeprazole which is a proton pump inhibitor (PPI), acts on the luminal surface of gastric parietal cells, resulting in inhibition of acid secretion. Esomeprazole provides higher rates of healing of erosive GERD and sustained resolution of heartburn in patients. Gastro-oesophageal reflux (GERD) is reflux of gastric contents into the esophagus. Heartburn is a very common symptom of GERD. GERD is often overseen and if untreated, can lead to conditions like peptic ulcer, chest pain, esophagus cancer & other fatal conditions. ]]> <![CDATA[Ziqitza Healthcare forays into corporate wellness sector]]> https://biospectrumindia.com/news/95/16828/ziqitza-healthcare-forays-into-corporate-wellness-sector.html https://biospectrumindia.com/news/95/16828/ziqitza-healthcare-forays-into-corporate-wellness-sector.html Fri, 10 Jul 2020 19:00:00 +0530 Mumbai based Ziqitza Healthcare Ltd (ZHL), Asia’s largest emergency medical service provider and one of the fastest-growing holistic healthcare solutions platforms in India, has announced its venture into Corporate Wellness services. The company has already signed up over 50 corporates from various sectors including E-commerce, Manufacturing companies, Insurance, IT, Real estate, FMCG amongst others. Aiming to become a “one-stop solution” for corporate wellness & holistic healthcare for corporates, ZHL offers turnkey solutions that include Ambulance at Site, Wellness at Workplace, Telehealth Services for Employees, Medical Rooms, Doctors on Site and Occupational Health Therapies, among others. Naresh Jain, CEO, Ziqitza Healthcare Ltd, shared his views on the expansion plan, “Since 2005, Ziqitza has consistently witnessed positive growth in the Ambulance Outsourcing and EMS segment. We have built a highly successful and differentiated PPP business and have introduced several international best practices in this area. The current pandemic has pretty much transformed the way urban India works and has underlined the need for actively reimagining workplace health and employee wellness. Ziqitza, with its vast experience in the pre-hospital segment and EMS outsourcing, is well-placed to provide solutions for the Corporate Wellness and Health sector. Focus on Quality Services and Customised Solutions are the main differentiators for ZHL from its peers in the industry.” “I am very happy to see the robust response we have received from the corporate world and we already have signed more than 50 clients since launched. Remote care for mental health has spiked, telehealth services are needed now more than ever. We are very confident about achieving our vision of becoming the leading EMS & Corporate Wellness Services provider in India and Mission 2025 of becoming a 100-crore company”, CEO, Naresh Jain. ]]> <![CDATA[Nav Wireless Technology extends help to combat COVID-19]]> https://biospectrumindia.com/news/95/16822/nav-wireless-technology-extends-help-to-combat-covid-19.html https://biospectrumindia.com/news/95/16822/nav-wireless-technology-extends-help-to-combat-covid-19.html Fri, 10 Jul 2020 08:40:00 +0530 Covid-19 patients in isolation wards at Surat Municipal Institute of Medical Education & Research (SMIMER), Surat (Gujarat) will get benefited from the latest Li-Fi technology. Ahmedabad based Li-Fi technology inventor, Nav Wireless Technology Pvt. Ltd is going to set up Li-Fi (Light Fidelity) technology-based communication facility at SMIMER. The company has extended its expertise to provide speedy, and safer light-based communication for Covid-19 patients and all the medical professionals. Li-Fi is a mobile wireless technology that uses light rather than radio frequencies to transmit data. In India, Nav Wireless is the only player working on Li-Fi in this segment. The company has successfully installed such a Li-Fi technology-based communication facility for various government institutions and private premises. With LiFi technology-based solutions, Doctors and Hospital Staff are minimized to the risk of spreading Coronavirus infection & at the same time provide a live health data monitoring system. “The administration had converted the multilevel parking premises at SMIMER into Covid-19 isolation wards in almost no time. These premises are going to be equipped with the latest Li-Fi technology. We are the only company in Asia in the Li-Fi sector to receive the first commercial Li-Fi project for the healthcare sector. We will set up around 600 such units there which are completely MADE IN INDIA. All the formalities related to this initiative have been completed with respective authority and we will start the commencement of the installation process very shortly", said Mr. Hardik Soni Co-founder & CTO, Nav Wireless Technology Pvt. Ltd. ]]> <![CDATA[Premas Biotech SARS-Cov-2 vaccine candidate moves ahead for animal trials]]> https://biospectrumindia.com/news/95/16821/premas-biotech-sars-cov-2-vaccine-candidate-moves-ahead-for-animal-trials.html https://biospectrumindia.com/news/95/16821/premas-biotech-sars-cov-2-vaccine-candidate-moves-ahead-for-animal-trials.html Fri, 10 Jul 2020 05:05:00 +0530 Gurugram-based Premas Biotech, which developed the world’s first triple antigen virus-like particle (VLP) vaccine candidate for SARS CoV-2 virus, announces that it has progressed into animal trials. At the moment, it is the only one from India to adopt a triple-antigen approach that is designed to produce an enhanced immune response. The four-week placebo-controlled, blinded and randomised tests to be conducted in mice, will seek to evaluate safety in the rodent model and examine immune response by dose titration. Premas Biotech plans to administer the test across different dose amounts, including human doses. The company has successfully completed the manufacturing process for the VLP (virus like particle) vaccine candidate, which includes three surface antigens from SARS-CoV-2. “We are excited that we have been able to manufacture and characterise the VLP containing three main proteins from SARS-CoV-2 virus. We are now moving ahead for animal trials using mice to analyse the safety and immunogenicity of the candidate. We believe it will be the first case of a triple-antigen VLP administered to an animal for SARS CoV-2,” said Prabuddha Kundu, Co-Founder and Managing Director, Premas Biotech. The data and findings of this study are expected in about six weeks. Describing the initiation of animal studies as an important milestone in the company’s vaccine development efforts, Dr Nupur Mehrotra, Chief Operating Officer and Co-Founder, Premas Biotech, said, “These animal trials will be crucial in testing the safety and efficacy of our vaccine candidate, and pave the path for our goal to enter first in human (FIH) trials. ” Premas Biotech, which is working on the development of the Covid-19 vaccine through proof of concept approach in collaboration with its US partner Akers Biosciences, has already established a manufacturing protocol and initiated large-scale production studies for the vaccine candidate. ]]> <![CDATA[Baxter India to use Oxiris Filter on COVID-19 patients]]> https://biospectrumindia.com/news/95/16818/baxter-india-to-use-oxiris-filter-on-covid-19-patients.html https://biospectrumindia.com/news/95/16818/baxter-india-to-use-oxiris-filter-on-covid-19-patients.html Thu, 09 Jul 2020 10:10:00 +0530 Baxter India has received approval from the Central Drugs Standard Control Organization (CDSCO) under Directorate General of Health Services, Ministry of Health & Family Welfare, India to use Oxiris Filter Set for the treatment of COVID-19 patients.  Oxiris Blood Purification Filter is intended for use in critically ill COVID-19 patients in need of Blood Purification where excessive Inflammatory Mediators are present i.e. Cytokine Storm release. Oxiris set was earlier used with the Prismaflex Control Unit for patients in need for Blood Purification including Continuous Renal Replacement Therapy (CRRT) and in conditions where excessive Endotoxins and Inflammatory Mediators level exists. “The COVID-19 cases in India have been spiralling and putting undue pressure on our healthcare system. This approval has come at a crucial time when such filter sets are much required to ease the burden on healthcare providers. We hope the availability of Oxiris will go a long way in fighting the COVID-19 cases in India. We extend our appreciation to the CDSCO for this approval”, said Ravinder Dang, VP, Commercial Excellence, APAC and General Manager, India. During Blood Purification Therapy, the patient’s blood passes through the Oxiris Filter Set, where it can absorb Inflammatory Mediators and remove Fluid, Electrolytes and Uremic Toxins, before returning the patient’s blood to the body. Making it the only filter set that does not necessitate the use of additional devices Renal Replacement Therapy (RRT) or removal of Troublesome Inflammatory Cytokines.  Oxiris is currently in use across countries in Europe and Asia and has been used for more than 10 years to treat thousands of patients. Oxiris has been validated for use with Baxter’s leading PrisMax and Prismaflex Systems.  ]]> <![CDATA[Takeda strengthens patient offering in India ]]> https://biospectrumindia.com/news/95/16823/takeda-strengthens-patient-offering-in-india-.html https://biospectrumindia.com/news/95/16823/takeda-strengthens-patient-offering-in-india-.html Thu, 09 Jul 2020 08:00:00 +0530 Takeda India, part of the Takeda Pharmaceutical Company Limited, a global values-based R&D-driven biopharmaceutical leader, has announced the expansion of its highly innovative portfolio for patients in the country with the launch of Kynteles® (generic name: Vedolizumab) as part of its Gastrointestinal (GI) portfolio. GI is Takeda's second therapeutic area in India after Rare Diseases (Haematology, Genetic Diseases, and Immunology). Kynteles® is used for the treatment of adult patients with moderate to severely active Ulcerative Colitis (UC) and Crohn's Disease (CD). Kynteles®, more widely known as Entvyio®, has shown favourable safety and efficacy results in treating patients suffering from moderate to severe IBD. Speaking about the launch, Koki Sato, Country Head, Takeda India, said, "At Takeda, we are continuously working towards developing innovative medicines to considerably improve the quality of life of patients. The launch of our highly innovative GI portfolio is a testimony of our commitment to India and patients living with diseases like UC and CD. Patient access to Kynteles® will further augment our vision of providing additional and innovative treatment options to HCPs treating UC and CD."   ]]> <![CDATA[Mylan secures DCGI approval for Remdesivir]]> https://biospectrumindia.com/news/95/16799/mylan-secures-dcgi-approval-for-remdesivir.html https://biospectrumindia.com/news/95/16799/mylan-secures-dcgi-approval-for-remdesivir.html Tue, 07 Jul 2020 07:15:00 +0530 Mylan N.V. has announced that the Drug Controller General of India (DCGI) has approved its remdesivir 100 mg/vial for restricted emergency use in India as part of the DCGI’s accelerated approval process to address urgent, unmet needs amid the evolving coronavirus 2019 (COVID-19) pandemic. The drug is approved for the treatment of suspected or laboratory confirmed incidences of COVID-19 in adults and children hospitalized with severe presentations of the disease.  The drug will be launched under the brand name DESREMTM in India and will be available to patients in July at a price of INR 4,800, which is more than 80% less than the price at which the branded version of this product will be available to governments in the developed world.   Mylan will manufacture remdesivir in India at its world-class injectables facilities, which also make product for the U.S. and have been inspected by the U.S. Food and Drug Administration (FDA) for compliance with good manufacturing practices. The company continues to work extensively toward expanding emergency use access for patients in the 127 low- and middle-income countries where it is licensed by Gilead Sciences to do so, subject to reviews by national regulatory bodies and the Prequalification Program of the World Health Organization (WHO). The approval by DCGI in India represents the first for Mylan in these 127 markets. Mylan President Rajiv Malik said: “Mylan and Gilead Sciences have partnered for many years to make high quality medicines available to people who need them and have made significant progress to reduce the incidence of infectious diseases, including HIV/AIDS, around the world. We commend Gilead for their continued leadership on this front, and also applaud and are proud to continue partnering with the DCGI for its ongoing efforts to accelerate access to critical medicine for patients with COVID-19 in India. Malik continued: “Our approval is a significant milestone for Mylan, for the global public health community and, most importantly, for patients who are battling this pandemic. Developing DESREM™ and bringing it to patients in India with such unprecedented speed is a testament to the strength of our global operations and scientific capabilities and our commitment to serving patients who continue to rely on us during this time. We are proud to continue our work in support of public health in partnership with governments and other stakeholders as we work together in the fight against COVID-19.” Rakesh Bamzai, President, India and Emerging Markets, said: “The growing global threat of COVID-19 requires a commitment to action by everyone involved in public health. Mylan is cognizant of its responsibility in fighting this pandemic and will leverage its global resources and capabilities including R&D, regulatory, manufacturing and supply chain, while engaging with key stakeholders across the licensed territories to serve the patients in need and further its mission of creating better health for a better world.”  ]]> <![CDATA[Zydus receives approval from Mexico to study Desidustat for COVID-19 management]]> https://biospectrumindia.com/news/95/16810/zydus-receives-approval-from-mexico-to-study-desidustat-for-covid-19-management.html https://biospectrumindia.com/news/95/16810/zydus-receives-approval-from-mexico-to-study-desidustat-for-covid-19-management.html Tue, 07 Jul 2020 00:00:00 +0530 Ahmedabad based Zydus, a leading discovery based global pharmaceutical company has announced that it has received approval from the regulatory authority of Mexico, COFEPRIS, for its one of its lead research candidate Desidustat to be tested in the management of COVID-19. COFEPRIS is a decentralized and autonomous body run by a commissioner appointed by the Mexican president . Clinical and regulatory development of Desidustat in COVID-19 is being executed in Mexico by Avant Santé Research Center S.A. de C.V., a leading Contract Research Organization (CRO) headquartered in Monterrey, Mexico. The company will be conducting a Phase 2b, Multicenter, Open-label, Randomized, Comparator- Controlled Study to Evaluate the Efficacy and Safety of Desidustat Tablet for the Management of COVID-19 patients. As a part of the study 100 mg tablets of Desidustat will be administered for a period of 14 days along with recommended standard care during the trial. Patients infected with COVID-19 have been reported to display signs of ‘Hypoxia’ leading to organ failure and death despite the use of antivirals, anti-inflammatory drugs or ventilators. The attack with the novel coronavirus pneumonia (COVID-19) will cause less and less haemoglobin that can carry oxygen and carbon dioxide. The lung cells have been reported to develop extremely intense poisoning and inflammation due to the inability to exchange carbon dioxide and oxygen frequently, which eventually results in ground-glass-like lung images. Desidustat (a hypoxia inducible factor prolyl hydroxylase inhibitor, currently undergoing Phase 3 trials) mimics the physiologic effect of altitude on oxygen availability. At higher altitudes, the body responds to lower oxygen availability with stabilization of hypoxiainducible factor, and this can lead to increased red blood cell production and improved oxygen delivery to tissues. Speaking on the development, Pankaj R. Patel, Chairman, Zydus Cadila said, “At Zydus, we have been stepping up our efforts to fight the Covid-19 pandemic through therapeutic drugs, diagnostics and vaccines. With Desidustat we will study a novel approach for management of Covid-19.” Zydus had initiated two Phase III trials of Desidustat. The DREAM-ND Phase III trial is being conducted in 588 CKD patients not-on-dialysis*. The DREAM-D Phase III trial is being conducted in 392 CKD patients on Dialysis# . Desidustat had previously met its primary endpoints in the Phase II clinical studies and showed good safety profile. The Phase I trials were earlier completed in Australia. ]]> <![CDATA[AstraZeneca’s Dapagliflozin receives approval in India for heart failure treatment]]> https://biospectrumindia.com/news/95/16797/astrazenecas-dapagliflozin-receives-approval-in-india-for-heart-failure-treatment.html https://biospectrumindia.com/news/95/16797/astrazenecas-dapagliflozin-receives-approval-in-india-for-heart-failure-treatment.html Mon, 06 Jul 2020 06:50:00 +0530 AstraZeneca Pharma India Limited (AstraZeneca India), a leading science-led biopharmaceutical company, has received the Marketing Authorization for Dapagliflozin (Forxiga),  for the treatment of patients with heart failure with reduced ejection fraction (HFrEF). This is the first in class SGLT-2 inhibitor drug approved for the treatment of  HFrEF and is the first drug proven to significantly reduce the risk of Cardiovascular death and hospitalisation for Heart Failure in patients with HFrEF. The approval follows positive results from the landmark Phase III DAPA-HF trial,  that proved that Dapagliflozin in addition to standard of care, reduced the risk of the composite outcome of Cardiovascular death or the worsening of Heart Failure versus placebo by 26%.   About one-fourth patients in the study population were  from Asian region including India. Gagandeep Singh, Managing Director, AstraZeneca Pharma India Limited said, “ Heart Failure is a serious health condition that affects ~6.4 crore people worldwide and at least 8–10 million in India. The accelerated regulatory approval in India will provide the much-needed treatment to help patients reduce their disease burden & live longer”. Dr. Anil Kukreja, Vice President – Medical Affairs & Regulatory, AstraZeneca India said, “Despite currently available therapies for management of Heart failure,  significant unmet needs exist globally as well as in India. This approval for Dapaglifozin (Forxiga) based on significant and clinically meaningful results from Dapa-HF trial provides much required confidence on a novel pharmacological approach, first in class SGLT2 inhibitor, for management of patients with HFrEF. This approval is boon for HFrEF patients in India where considerable efforts are required to address significant unmet needs of frequent hospitalization, urgent visits to hospital emergency room and cardiovascular death in HF patients despite available therapies ” The U.S. Food and Drug Administration approved Dapagliflozin to be used in management of patients with heart failure with reduced ejection fraction. The Canadian Cardiovascular Society has updated their guidelines  and recommend the use of SGLT2i drugs like Dapagliflozin to manage heart failure  to provide better patient care. Dapaglifozin (Forxiga) is also indicated as an adjunct to diet and exercise to improve glycaemic control in adults with T2D in India. The drug is also approved for reduction of risk of hospitalisation due to Heart failure in Type 2 Diabetes patients with high risk factors. ]]> <![CDATA[Zydus to initiate COVID-19 vaccine trials in July]]> https://biospectrumindia.com/news/95/16788/zydus-to-initiate-covid-19-vaccine-trials-in-july.html https://biospectrumindia.com/news/95/16788/zydus-to-initiate-covid-19-vaccine-trials-in-july.html Mon, 06 Jul 2020 05:10:00 +0530 Ahmedabad based Zydus has announced that it’s plasmid DNA vaccine candidate for COVID-19 (ZyCoV-D) developed indigenously at its Vaccine Technology Centre in Ahmedabad, has successfully completed the preclinical phase and has now received permission from the Drug Controller General of India - Central Drugs Standard Control Organisation (CDSCO) to initiate Phase I/II human clinical trials in India. In animal studies the vaccine was found to elicit a strong immune response in multiple animal species like mice, rats, guinea pigs and rabbits. The antibodies produced by the vaccine were able to completely neutralize the wild type virus in virus neutralization assay indicating the protective potential of the vaccine candidate. No safety concerns were observed for the vaccine candidate in repeat dose toxicology studies by both intramuscular and intradermal routes of administration. In rabbits, up to three times the intended human dose was found to be safe, well tolerated and immunogenic. Zydus has already manufactured clinical GMP batches of the vaccine candidate and plans to initiate the clinical trials in July 2020 across multiple sites in India in over 1000 subjects. With ZyCoV-D, the Company has successfully established the DNA vaccine platform in the country using non-replicating and non-integrating plasmid carrying the gene of interest making it very safe. Further, no vector response and with absence of any infectious agent, the platform provides ease of manufacturing the vaccine with minimal biosafety requirements (BSL-1). The platform is also known to show much improved vaccine stability and lower cold chain requirements making it easy for transportation to remotest regions of the country. Furthermore, the platform can be rapidly used to modify the vaccine in couple of weeks in case the virus mutates to ensure that the vaccine still elicits protection. Company intends to now rapidly ramp up the production capacities of ZyCoV-D at multiple sites and facilities to cater to Indian and global demand. ]]> <![CDATA[Emcure Pharma offers hope for CKD patients]]> https://biospectrumindia.com/news/95/16784/emcure-pharma-offers-hope-for-ckd-patients.html https://biospectrumindia.com/news/95/16784/emcure-pharma-offers-hope-for-ckd-patients.html Fri, 03 Jul 2020 07:15:00 +0530 Mumbai based Emcure Pharmaceuticals, an Indian integrated global pharmaceutical company has launched India's first generic version of sucroferric oxyhydroxide for the control of increased serum phosphorus levels in patients with chronic kidney disease (CKD) on dialysis. The drug will be sold under the brand name Dynulta. Its active component is sucroferric oxyhydroxide developed indigenously by Emcure. Dynulta will be manufactured at Emcure's state-of-the-art plant at Jammu and will be marketed at less than 70% cost of the innovator brand. "The incidence of CKD is on the rise in India. Dynulta will provide efficacious and cost- effective remedy for Indian patients", said Ms. Namita Thapar, Executive Director, Emcure Pharmaceuticals ltd Recent data from the International Society of Nephrology's Kidney Disease Data Centre reported a prevalence of 17% of CKD in India. Diabetes and hypertension accounts for most CKD cases. By 2030, India is expected to have the world's largest population of diabetes patients. There are several other issues that contribute to the high prevalence of CKD in India. Hyperphosphatemia is a serious and common consequence of advanced CKD. Hyperphosphatemia is associated with increased risk of cardiovascular events and mortality in patients undergoing dialysis. Dietary restrictions and dialysis alone are usually insufficient to control hyperphosphatemia therefore an effective phosphate binder is needed to control increased phosphate level. Sucroferric oxyhydroxide displays a high phosphate binding capacity, resulting in effective serum phosphorous control. This was demonstrated in a phase III study of sucroferric oxyhydroxide versus sevelamer. Real-world studies show that patients who switch to sucroferric oxyhydroxide from another phosphate binder achieve better long-term serum phosphorous control with a lower number of pills. A lower pill burden can translate into better patient compliance to treatment. Studies have shown that sucroferric oxyhydroxide is effective in the reduction of serum phosphorous in a broad range of dialysis patients. The innovator company for sucroferric oxyhydroxide is Vifor Fresenius Medical Care Renal Pharma Ltd, a joint operation between Vifor Pharma and Fresenius Medical care, providers of dialysis services. It is marketed internationally as Velphoro, which is not available in india. Emcure Pharmaceuticals ltd has made it available/accessible Dynulta, for the first time in India. ]]> <![CDATA[Dr Reddy's partners with Fujifilm for COVID-19 drug]]> https://biospectrumindia.com/news/95/16785/dr-reddys-partners-with-fujifilm-for-covid-19-drug.html https://biospectrumindia.com/news/95/16785/dr-reddys-partners-with-fujifilm-for-covid-19-drug.html Fri, 03 Jul 2020 06:10:00 +0530 Hyderabad based Dr. Reddy's Laboratories Ltd. has announced partnering with Japanese firm FUJIFILM Corporation through FUJIFILM Toyama Chemical Co. Ltd. and Global Response Aid (GRA) for the development, manufacture and sales of Avigan® Tablets (generic name: favipiravir), a potential treatment of COVID-19. Under the tripartite agreement signed, FUJIFILM grants Dr. Reddy’s the exclusive rights of manufacturing and also grants both Dr. Reddy’s and GRA the rights to develop, sell and distribute Avigan® in all countries other than Japan, China and Russia. Dr. Reddy’s would have exclusive rights for development, selling and distribution of Avigan® in India. Further, FUJIFILM would receive an upfront license fee and royalties on sales from Dr. Reddy’s and GRA. FUJIFILM will provide Dr. Reddy’s and GRA with an array of data on Avigan®’s preclinical and clinical studies that FUJIFILM has accumulated thus far. Dr. Reddy’s and GRA will use this data for clinical studies targeting COVID-19 in regions where infection has been spreading. In addition, FUJIFILM will grant Dr.Reddy’s right to use Avigan®’s patents of formulation and manufacturing method. Dr. Reddy’s will herewith establish a setup for manufacturing drugs of the same quality as Avigan®, and utilize GRA’s global sales network to supply the manufactured drugs swiftly and in a stable manner. The FUJIFILM Group is currently conducting a clinical study on Avigan® targeting COVID-19 patients in Japan and the US, and is working to increase the drug’s production by partnering with domestic and overseas companies. Dr. Reddy’s and GRA shall introduce the product in the market post all applicable approvals in the respective countries. ]]> <![CDATA[VingaJoy launches range of Essential Products]]> https://biospectrumindia.com/news/95/16794/vingajoy-launches-range-of-essential-products.html https://biospectrumindia.com/news/95/16794/vingajoy-launches-range-of-essential-products.html Fri, 03 Jul 2020 00:00:00 +0530 New Delhi based Vingajoy has launched its range of safety products that comprises of face shields, face masks and hand sanitizers. The brand through its latest product line is helping people to adopt a new habit, i.e., to own a basic kit of safety essentials that one must always carry with themselves before stepping out of their homes. All three products have been designed keeping in mind the unique features and importance they entail. VingaJoy’s Face Guard features a visor which is made up of high-quality polycarbonate material ensuring flexibility and full-face protection through its coverage. It comes with a comfortable headband and forehead support. Thus, maximum comfort is guaranteed for longer usage. It can effectively help in blocking droplets, bacteria, and dust; ensuring safety complete safety of your face. VingaJoy has come up with 2 variants of Face Mask VM-10 and VM- 33 ensuring maximum comfort and breathability. VM-33 Face Mask is a pure cotton mask offering a unique feature of reversible wear. This mask is completely made of soft cotton which comes with comfortable ear loops. It's three-dimensional structure prevents the anti-dust and germs from entering through the mask. Understanding a core element people sought out for while choosing a mask, this haze-free mask ensures that healthy air can easily be inhaled through its filtration. VingaJoy’s hand sanitizers are bottled in 3 different quantities, 100ml, 200ml, and 500ml respectively, which are easy to carry. The alcohol content in the liquid is sufficient to kill 99.99% of germs without water. It also protects the skin from oxidative damage and helps to prevent itching. The liquid is non-sticky with long-lasting fragrance. Commenting on the release of the new line-up, Mr. Lalit Arora, Co-Founder, VingaJoy commented, “Hon’ble Prime Minister of India appreciated the MSMEs for helping the nation fighting with COVID-19 in different ways. Our vision is clear, to make our nation self-sufficient with the manufacturing of safety products, consumer tech goods, and VocalforLocal Products. This move will surely help India in generating more jobs and higher GDP, promoting our mission of MAKE IN INDIA.” Aimed at eliminating the market shortage of safety products and serving as many customers as possible, the company is readily taking bulk orders for the same across the nation to provide utmost protection from the virus to one and all. ]]> <![CDATA[Cipla and Boehringer Ingelheim partner for three oral anti-diabetic drugs]]> https://biospectrumindia.com/news/95/16759/cipla-and-boehringer-ingelheim-partner-for-three-oral-anti-diabetic-drugs.html https://biospectrumindia.com/news/95/16759/cipla-and-boehringer-ingelheim-partner-for-three-oral-anti-diabetic-drugs.html Tue, 30 Jun 2020 05:05:00 +0530 Cipla Limited and Boehringer Ingelheim India Pvt. Ltd. have announced their partnership in India to co-market three new oral anti-diabetics drugs Oboravo® (Empagliflozin), Oboravo Met® (Empagliflozin+Metformin) and Tiptengio® (Empagliflozin+Linagliptin) Empagliflozin is approved for glucose-control in patients with type-2 diabetes; it is also approved for reducing the risk of cardiovascular death, in patients with type-2 diabetes and established cardiovascular disease. The Empagliflozin + Metformin combination Oboravo Met® can be given to newly diagnosed patients of type-2 diabetes who have higher baseline HbA1c levels. The Empagliflozin + Linagliptin combination Tiptengio® is the world’s first approved combination of an SGLT-2 inhibitor and DPP4 inhibitor. In addition to a strong effect on lowering blood sugar levels, it also addresses multiple pathophysiological defects in type 2 diabetes, and is a big step towards improved management of type 2 diabetes. It will also help in reducing the pill burden for patients and help improve adherence to the prescribed treatment. As per the International Diabetes Federation, India is home to 77 million adults aged between 20 and 79 years with diabetes, ranking second behind China; and is poised to 2 | 3 reach 134.2 million patients by 2045. Fortunately, while the number of patients is increasing, so is the awareness among the public to address it. The Indian diabetes market is valued at INR 1,45,451 million and is growing at 10.35% (IMS MAT May 2020) with the oral anti-diabetic market being valued at INR 1,07,354 million and growing at 11.34% (MS MAT May 2020). Commenting on the partnership, Nikhil Chopra, Executive Vice President & CEO - India Business, Cipla said, “We are committed to providing access to innovative medications that address unmet patient needs. Diabetes continues to be a focus area for Cipla and with a strategic partnership with Boehringer Ingelheim coupled with our strong brand building, patient access and reach capabilities, we will be at the forefront of providing holistic diabetes care.” Commenting on the expanded partnership, Mr. Sharad Tyagi, Managing Director Boehringer Ingelheim India said, “We are excited about the expansion of our partnership with Cipla to provide pioneering medicines through the new oral anti-diabetics drugs. As a dedicated organization to the field of diabetes, we aim to provide wider access and innovative solutions to the medical fraternity and patients with one of the most comprehensive Diabetes portfolios in the country.” ]]> <![CDATA[Bharat Biotech to initiate Ph 1 & 2 trials for COVID-19 vaccine]]> https://biospectrumindia.com/news/95/16761/bharat-biotech-to-initiate-ph-1-2-trials-for-covid-19-vaccine.html https://biospectrumindia.com/news/95/16761/bharat-biotech-to-initiate-ph-1-2-trials-for-covid-19-vaccine.html Tue, 30 Jun 2020 04:05:00 +0530 Bharat Biotech, has successfully developed COVAXIN™️,  India’s 1st  vaccine candidate for COVID-19, in collaboration with the Indian Council of Medical Research (ICMR) - National Institute of Virology (NIV). The SARS-CoV-2 strain was isolated in NIV, Pune and transferred to Bharat Biotech. The indigenous, inactivated vaccine developed and manufactured in Bharat Biotech’s BSL-3 (Bio-Safety Level 3) High Containment facility located in Genome Valley, Hyderabad, India.The Drug Controller General of India - CDSCO, Ministry of Health & Family Welfare granted permission to initiate Phase I & II Human clinical trials after the company submitted results generated from preclinical studies, demonstrating safety and immune response. Human clinical trials are scheduled to start across India in July 2020.Announcing the vaccine development milestone, Dr. Krishna Ella, Chairman and Managing Director said: “We are proud to announce COVAXIN™️, India’s first indigenous vaccine against COVID-19.The collaboration with ICMR and NIV was instrumental in the development of this vaccine. The proactive support and guidance from CDSCO has enabled approvals to this project. Our R&D and Manufacturing teams worked tirelessly to deploy our proprietary technologies towards this platform.”Expedited through national regulatory protocols , the company accelerated its objective in completing the comprehensive pre-clinical studies. Results from these studies have been promising and show extensive safety and effective immune responses. ]]> <![CDATA[Wellthy reveals success of digital therapeutics for diabetes control]]> https://biospectrumindia.com/news/95/16762/wellthy-reveals-success-of-digital-therapeutics-for-diabetes-control.html https://biospectrumindia.com/news/95/16762/wellthy-reveals-success-of-digital-therapeutics-for-diabetes-control.html Tue, 30 Jun 2020 00:00:00 +0530 Digital therapeutics innovator Wellthy Therapeutics showcased compelling data on the effectiveness of their digital therapeutics platform in combination with a self-monitoring blood glucose (SMBG) device by Roche Diabetes Care, at the annual American Diabetes Association conference. The study evaluated data from 286 individuals with diabetes over a period of six months, and tracked baseline, month 2, month 4 and month 6 blood sugar readings. Participants used both the Accuchek Active® blood glucose monitor and the Wellthy Care Digital Therapeutics platform, to form an iPDM (integrated personalized diabetes management) solution. The blood glucose monitor was used by patients to monitor blood glucose values while the digital therapeutic platform provided real-time support and guided digital journeys for better self-management of diabetes. Participants reported a significant drop in blood glucose levels in the first two months which was maintained consistently from month 2 to month 6. Mean Blood Glucose readings recorded a 24mg/dl reduction from 156.19mg/dl to 130.25mg/dl; Fasting Blood Glucose recorded a 16mg/dl reduction from 135.85mg/dl to 119.92mg/dl while Post Meal Blood Glucose recorded a 26mg/dl reduction from 178.21mg/dl to 153.37mg/dl. Participants progressively showed upto a 40% decrease in glucose variability with an 80% reduction in the proportion of hypoglycemic events over 6 months, while demonstrating better self-care behaviours such as better adherence to self-monitoring of blood glucose. Dr. Banshi Saboo, nationally acclaimed Diabetologist and co-author said, “This study is worth celebrating because it has achieved the trifecta of blood glucose control. It has proven SMBG adherence, sustained glycemic control and shown reduction in variability over a longer period of time. The impact of this combination therapy that uses a SMBG device and a digital therapeutic platform can have an exponential impact in tackling the diabetes burden in India and lower the burden on the healthcare sysem.” Abhishek Shah, CEO, Wellthy Therapeutics said, “Patient reported outcomes and a personalized insights engine on the same play an important role in the comprehensive management of a patient’s condition. Digital therapeutics take digital biomarkers and ePROs and combine these measurable health indicators with patient behaviours and clinical intelligence, to deliver actionable insights in the real world, while delivering guided digital therapeutics to handhold every user.  Empowered patients are capable of sustained improvement in health outcomes, which is the most important aspect of healthcare.”  ]]> <![CDATA[Sanofi launches 'Allegry Free' awareness campaign ]]> https://biospectrumindia.com/news/95/16765/sanofi-launches-allegry-free-awareness-campaign-.html https://biospectrumindia.com/news/95/16765/sanofi-launches-allegry-free-awareness-campaign-.html Tue, 30 Jun 2020 00:00:00 +0530 This World Allergy Week (June 28 – July 04), Sanofi India Limited launches a multi-channel educational initiative to raise awareness about allergies and their impact on the quality of life. Given the sensitivities of the current global pandemic, there is a lurking sense of fear that has gripped everyone. Allergy free helps keep people informed on the typical symptoms of allergies, flu and cold, and the main warning signs of COVID-19. The website www.allergyfree.co.in is a comprehensive and regularly updated portal. Taking this information to where our customers really access it, this portal also links across various social media channels including Facebook (@AllergyFreeInd), Twitter (@AllergyFree), Instagram @AllergyFreeIndia) and YouTube (AllergyFree India). Commenting on the launch, Nikhilesh Kalra, General Manager – Consumer Healthcare, India & South Asia, Sanofi, said, “In India, while the prevalence of allergies has increased five times, but  50% of the allergy sufferers are unaware of this problem. Allergies can have a major impact on people’s productivity and their sense of well-being. Importantly, if ignored, allergies could have long-term consequences on their health. Therefore, there is a real need for a revolutionary shift in mindset towards allergies. ‘AllergyFree’ is our endeavour to raise awareness so that people can ‘live allergy-free’.” The comapny also runs educational programs from time to time including medical experts and people living with allergies to help understand allergies better. They reach out to people via print, radio, digital platforms and now social media handles.  ]]> <![CDATA[Sun Pharma reveals new data to treat T2D & obesity]]> https://biospectrumindia.com/news/95/16750/sun-pharma-reveals-new-data-to-treat-t2d-obesity.html https://biospectrumindia.com/news/95/16750/sun-pharma-reveals-new-data-to-treat-t2d-obesity.html Mon, 29 Jun 2020 08:05:00 +0530 Mumbai based Sun Pharmaceutical Industries Ltd. has announced an update on a pre-clinical molecule. The experimental New Chemical Entity (NCE), GL0034 is a long-acting GLP-1R (Glucagon-Like Peptide-1 Receptor) agonist. Such agonists are used to treat patients with type 2 diabetes, including short-acting, intermediate-acting, and long-acting therapies. Pre-clinical performance of GL0034 was assessed in a highly relevant type 2 diabetes db/db mouse model. The NCE demonstrated significant outcomes on various diabetic parameters evaluated, viz. glucose reduction, decrease in HbA1c (an important marker for clinical efficacy), augmented insulin secretion, lowering of glucagon level and a marked and meaningful reduction in triglyceride levels. All these outcomes with GL0034 were found to be higher or significant to the currently marketed once a week GLP-1R agonists compared in the study. Yet another important feature in diabetes treatment is weight management. GL0034 induced a larger body weight reduction, 1.9x and 3.8x times higher than the two different standard once a week GLP-1R agonist drugs compared in the study, with similar food consumption. Dilip Shanghvi, Managing Director, Sun Pharma said, “We are excited by the robust pre-clinical data for GL0034 and believe that it has significant potential. We look forward to validating this data in human clinical trials.” Sun Pharma is planning to initiate Phase-1 clinical trials for GL0034 by Q3FY21. ]]> <![CDATA[Cadila Pharma launches anti allergic drug Bilastine in India]]> https://biospectrumindia.com/news/95/16742/cadila-pharma-launches-anti-allergic-drug-bilastine-in-india.html https://biospectrumindia.com/news/95/16742/cadila-pharma-launches-anti-allergic-drug-bilastine-in-india.html Fri, 26 Jun 2020 06:50:00 +0530 Cadila Pharmaceuticals Limited has recently announced the launch of Bilastine syrup (30 ml) and Bilastine tablets in the strength of 20mg. It is indicated that Bilastine, an antihistamine drug is used in the treatment of allergic rhinitis. Bilastine is an antihistamine which addresses the current gap in the treatment of Allergic Rhinitis and meets the expectations of doctors to treat their allergic rhinitis patients. The Bilastine has an advantage over other molecules available in the category, as faster onset of action, non-drowsy, cardiac safe. Cadila Pharmaceutical’s product under the brand name Bilacad also ensures better safety and efficacy. India has seen a growth in the number of cases of allergic rhinitis induced due to tobacco smoke, exposure to air pollutants, vehicular pollution, and other air pollution. Moreover as per a recent study published in Lung India 65% of the Indian allergic rhinitis patients also suffer from Asthma. Improved control of nasal allergies can help gain better control on Asthma. Cadila Pharmaceuticals Ltd. is one of the largest privately-held pharmaceutical company of India. It has recently concluded USFDA inspection successfully in February 2020. Over the past six decades, Cadila Pharmaceuticals is engaged into development and manufacturing of affordable medicines and make them available for patients across the world. Its innovation-led drug discovery processes ensure the health and well-being of people around the world. ]]> <![CDATA[Hetero set to supply Remdesivir as COVIFOR]]> https://biospectrumindia.com/news/95/16743/hetero-set-to-supply-remdesivir-as-covifor.html https://biospectrumindia.com/news/95/16743/hetero-set-to-supply-remdesivir-as-covifor.html Fri, 26 Jun 2020 06:10:00 +0530 Following the approval of 'COVIFOR', the generic of Remdesivir by DCGI, Hetero Healthcare Limited, a group company of Hetero is set to deliver the first set of 20,000 vials in two equal lots of 10,000 each, one of which, will be immediately supplied to Hyderabad, Delhi, Gujarat, Tamil Nadu, Mumbai and other parts of Maharashtra; while the other lot will be supplied to Kolkata, Indore, Bhopal, Lucknow, Patna, Bhubaneshwar, Ranchi, Vijayawada, Cochin, Trivandrum and Goa within a week's time, in order to meet the emergency requirements.Mr. M. Srinivasa Reddy, Managing Director, Hetero Healthcare Limited said: "The launch of COVIFOR in India is a significant milestone for all of us. Hetero Healthcare has always been at the forefront in addressing public health emergencies. Through Covifor, we hope to reduce the treatment time of a patient in a hospital, thereby reducing the increasing pressure on the medical infrastructure, overburdened currently due to accelerating COVID-19 infection rates. We are working closely with the Government and Medical Community to make 'Covifor' quickly accessible to both public and private healthcare settings across the country."Covifor is the first generic brand of Remdesivir which is indicated for the treatment of COVID-19 patients in adults and children, hospitalized with severe symptoms of the disease. The drug is available in 100 mg vial (Injectable). It needs to be administered intravenously in a hospital, critical care setting, under the supervision of a registered medical practitioner. Covifor is anticipated to play a significant role in bringing down the mortality rates caused by Covid-19, given its proven positive clinical outcomes. ]]> <![CDATA[Digital Transformation is need of the hour for Indian Pharma industry]]> https://biospectrumindia.com/news/95/16752/digital-transformation-is-need-of-the-hour-for-indian-pharma-industry.html https://biospectrumindia.com/news/95/16752/digital-transformation-is-need-of-the-hour-for-indian-pharma-industry.html Fri, 26 Jun 2020 00:00:00 +0530 C Com Digital – a full-service digital marketing agency, unveiled the details of its whitepaper study conducted to explore the impact of COVID-19 on the Indian Pharmaceutical industry. The report brought the attention firmly on the urgent need for the pharmaceutical organizations thriving on age-old business models to embrace the world of digital marketing and leverage technology to their optimum advantage. Nearly 35% of the operations of the pharma companies need to be shifted digital, according to the survey. The study was carried out in collaboration with some of the leading decisionmakers and business consultants from across India to gauge the impact of COVID-19 on their organizations as well as the whole of the pharma industry. Most of the respondents that participated in the survey experienced complacency in the industry with respect to heavy dependency on the out-of-date B2B model and hesitance to adopt changes due to ROI centricity prevailing for decades. The online digital survey said that majority of the top management officials believed that COVID-19 has already brought about a strategic shift in the way pharma companies function and engage with physicians and other clients on a day to day basis. Teleconsultation and online consultation has seen a steady spike infact, around 42% of patients are taking prescriptions by Tele Consultation and Doctor visits had dropped by almost 5% during the period of March – April 2020. To add, the biggest concern for most of these organizations remains to undertake measures for continued remote working facilities and minimizing direct engagement by establishing digital routes. C Com’s research highlights a heavy focus on digital engagement, with a majority of respondents seeking to invest in social media, video marketing, and online meeting set-ups for staying relevant as well as connected to the medical experts, customers, and other stakeholders. The study also saw that, pharmaceutical companies are considering dedicating about 5% to 10% of their marketing budget towards creating webinars and online communications. Moreover, the report identifies that many large-scale pharma companies are now looking to place their bet on online patient education and online training of field staff through the means of comprehensive soft skill modules and dedicated e-learning programs from a perspective of sustainable development goals. In fact, few of the companies are already leveraging AI-driven models to gain a competitive advantage over others and to build engagement with their clients from newsletters.   One of the insights from the study has been: 72% of consumers feels that it was appropriate for pharma to continue their promotions, only about a 25% of all consumers did not think pharma should promote during this time. 84% wanted to know how to deal with COVID-19 or communication related to it and 51% wanted public service messages during COVID-19 and 47% wanted patient assistance programs. “It’s time for pharma companies to respond positively to digitization; since it’s here to stay for a long while now. In general, when we are talking about the ‘new normal’, we must understand that employees can work remotely with utmost productivity, but the key remains to prepare ourselves, as an organization, to adjust and adopt new changes quickly as per the changing environment, so that there’s victory at the end of the dark tunnel. And now, as we analyze the report of the survey, it’s clear that to tackle the existing challenges in the pharma industry, we must let the best options and capabilities walk up to the table,” said Chandan Bagwe, Founder and Managing Director, C Com Digital. Guidelines or not, pharma companies are slowly picking up the pace to go digital, primarily by looking at social media for communication and engagement. In the days to come, it is certain that most of these businesses will find an alternative to demonstrate their offerings, either through applications or video content. Clearly, the position of the industry and the present-day scenario points out that more and more pharma companies will dedicate a larger portion of their budgets towards digital marketing as against advertising or branding. Perhaps, the progress and success post-COVID-19 will be primarily reliant on agile working models, sagacious strategies, and adaptable workforces. ]]> <![CDATA[Novaerus' air disinfectant device effectively reduces coronavirus surrogate]]> https://biospectrumindia.com/news/95/16741/novaerus-air-disinfectant-device-effectively-reduces-coronavirus-surrogate.html https://biospectrumindia.com/news/95/16741/novaerus-air-disinfectant-device-effectively-reduces-coronavirus-surrogate.html Thu, 25 Jun 2020 00:00:00 +0530 There is mounting research to suggest that clean, disinfected air plays a vital role in preventing the spread of SARS-CoV-2, the virus causing COVID -19. While respiratory droplets are considered the primary transmission route, aerosols are being considered by many health authorities as a possible mode of infection transmission. This advocates that viral particles can remain suspended in the air for long periods and can be inhaled. To combat that, Novaerus - an Irish company that manufactures and sells patented medical- grade, clean air solutions, has announced successful independent test results for the Defend 1050. The portable air disinfection device has shown effective results at reducing MS2 Bacteriophage, a surrogate for SARS-CoV-2 (COVID-19), by 99.99% in 15 minutes. The Defend 1050 combines rapid air disinfection and purification into one safe and portable device. Designed for continuous cleaning of the air in large spaces and rapid remediation in situations with a high risk of infection, the device uses Novaerus patented ultra-low energy plasma technology combined with a triple-stage filtration system from Camfil. As Novaerus plasma is a non-selective, rapid killing technology, it offers a unique and safe solution to kill airborne viruses 24/7, reducing the risk of disease and infectious outbreaks like COVID-19, Influenza, Tuberculosis, Measles, MRSA (Superbug), Norovirus, C-Difficile, Acinetobacter, Aspergillus Niger, etc. Since 2009, Novaerus has been researching and developing plasma technology that is unmatched in its ability to safely terminate airborne pathogens that lead to infection in populated indoor spaces. To bring this technology into India, Trivector Biomed LLP has been a partner to Novaerus since 2016. Mr. Dilip Patil, Director of Trivector Biomed LLP said, “Novaerus, specializes in non-chemical air disinfection using patented ultra-low energy plasma devices that has achieved a remarkable feat. The new Defend 1050 is a portable, easy to use device ideal for rapid disinfection and purification of the air in large spaces and high-risk situations such as operating theatres, ICUs, IVF labs, emergency and waiting rooms, schools, offices and construction zones. Our aim is to make this product available at a low cost or even put it out on rent in order to help maximum people in India.” The development of Novaerus has been supported by Enterprise Ireland through several support programs and market development activities.  ]]> <![CDATA[Cipla launches Cipremi for COVID-19 treatment]]> https://biospectrumindia.com/news/95/16714/cipla-launches-cipremi-for-covid-19-treatment.html https://biospectrumindia.com/news/95/16714/cipla-launches-cipremi-for-covid-19-treatment.html Tue, 23 Jun 2020 08:05:00 +0530 Mumbai based Cipla Limited has announced the launch of remdesivir under its brand name CIPREMI. The U.S. FDA issued an Emergency Use Authorization (EUA) to Gilead Sciences Inc. for emergency use of remdesivir for the treatment of hospitalized 2019 coronavirus disease (COVID-19) patients. It is the only U.S. FDA approved Emergency Use Authorisation (EUA) treatment for adult and paediatric patients hospitalized with suspected or laboratory confirmed COVID-19 infection. In May, Gilead Sciences Inc. extended a voluntary non-exclusive license to Cipla to manufacture and market Cipla’s generic version of remedisvir called CIPREMI. Cipla has been granted regulatory approval by the Drug Controller General of India (DCGI) for restricted emergency use in the country as part of the accelerated approval process considering the urgent and unmet medical need. As part of a risk management plan, Cipla will provide training on use of the drug, informed patient consent documents, conduct post marketing surveillance as well as conduct a Phase IV clinical trial on Indian patients. According to a preliminary report from the ACTT-1 (Adaptive COVID-19 Treatment Trial 1) study1, a randomized clinical trial conducted with remdesivir in 1063 patients over 60 centres across U.S., Europe and Asia demonstrated a faster time to clinical recovery in hospitalised patients as compared to placebo. Most of these patients were on oxygen therapy of which some were receiving high flow oxygen or non-invasive ventilation, and some were on a mechanical ventilator. The mortality rates in the study were 7.1% in those given remdesivir and 11.9% in those who were given placebo. As part of its efforts to enable speedy and equitable access to this treatment and in anticipation of demand, Cipla will be commercialising remdesivir through its own facilities and partnered sites. The drug will be supplied through Government and open market channels, to ensure equitable distribution. Commenting on the launch, Mr. Umang Vohra (MD and Global CEO, Cipla Limited) said, “Cipla appreciates the strong partnership with Gilead to bring remdesivir to patients in India. We have been deeply invested in exploring all possible avenues to save millions of lives impacted by COVID-19 pandemic, and this launch is a significant milestone in that direction. We will continue to collaborate with all stakeholders in the healthcare ecosystem towards providing access to such promising treatments in furtherance with our belief that no patient should be denied access to life-saving treatments.” ]]> <![CDATA[Roche Pharma India expands partnership with Cipla ]]> https://biospectrumindia.com/news/95/16689/roche-pharma-india-expands-partnership-with-cipla-.html https://biospectrumindia.com/news/95/16689/roche-pharma-india-expands-partnership-with-cipla-.html Mon, 22 Jun 2020 08:05:00 +0530 Roche Products (India) Pvt. Ltd. (Roche Pharma) and Cipla Limited have announced that the two companies have entered into an agreement to provide better access to innovative medicines for patients in India. Under this agreement, Cipla will be responsible for marketing and distribution of Roche Pharma’s key trademark oncology drugs viz.,Trastuzumab (Herclon), Bevacizumab (Avastin) and Rituximab (Ristova). Roche and Cipla had previously entered into a similar agreement in February 2018 for promotion and distribution of Tocilizumab (Actemra) and other products. “We have been working as a partner with Cipla for some of our products and it has been a great journey working with them in ensuring access to our innovations in India. We hope to extend the same support to patients in India through this new agreement.”, said V. Simpson Emmanuel, General Manager, Roche Products (India) Pvt. Ltd. “This deal will ensure that our focus on providing Roche innovations in India remains steadfast in this portfolio and we will keep on collaborating with the relevant stakeholders in Indian healthcare system to ensure better outcomes for patient..” Commenting on the partnership, Nikhil Chopra, Executive Vice President & CEO - India Business, Cipla said, “Enabling access to high quality life-saving treatments is core to our purpose of ‘Caring for Life’. We are pleased to strengthen our partnership with Roche towards bringing innovative oncology medications to India. This represents our unwavering commitment to address the unmet needs of cancer patients through an enhanced portfolio of offerings in this space. We look forward to leveraging our solid marketing and distribution strengths in India to provide broader access to such transformative treatments in the country.” ]]> <![CDATA[Piramal Pharma acquires SODD facility from G&W Labs]]> https://biospectrumindia.com/news/95/16711/piramal-pharma-acquires-sodd-facility-from-gw-labs.html https://biospectrumindia.com/news/95/16711/piramal-pharma-acquires-sodd-facility-from-gw-labs.html Mon, 22 Jun 2020 08:05:00 +0530 Piramal Enterprises Limited’s (PEL) Pharma Solutions business, a leading Contract Development and Manufacturing Organization (CDMO), has announced that the Company has entered into an agreement with G&W Laboratories Inc. to acquire its solid oral dosage drug (SODD) product manufacturing facility located in Sellersville, Pennsylvania. The transaction closure is subject to customary pre-closing conditions. According to the terms of the agreement, PEL, through one of its Affiliates, would acquire at closing a 100% stake in the entity that operates the facility and owns the related real estate. This acquisition broadens the offering of Piramal Pharma Solutions (PPS) by adding solid oral dosage form capabilities (tablets and capsules) in North America. Until now, PPS’ capabilities in solid oral dosage forms were all located in the UK and India. The Sellersville site can also produce liquids, creams, and ointments, further expanding the PPS portfolio. The site also can support product and process development for solid oral dosage and oral liquids, including immediate release, modified release, chewable & sublingual solid oral dosage forms, solutions and suspensions in liquids. The site has received certifications from the FDA and EMA. “Many of our customers are looking for US-based manufacturing partners to expand and support their pipeline. This acquisition strengthens our ability to partner with them on best-in-class drug products. It enhances our market-leading integrated services offering by adding a solid oral dosage capability in the US. We now offer solid oral drug product development and commercial manufacturing in all our major geographies, addressing a previously unmet customer need and strengthening our ability to work globally with customers to reduce the burden of disease on patients,” said Peter DeYoung, Chief Executive Officer, Piramal Pharma Solutions The Sellersville site covers 31.5 acres of land with over 221,000 square feet of manufacturing space, including 195,000 square feet of GMP area. The site features dedicated manufacturing and packaging technologies for solid oral dosage forms, liquids, creams, and ointments; QC and microbiology labs; state-of-the-art preformulation and analytical development infrastructure coupled with a pilot lab for research and development; and a temperature-controlled warehouse. The site currently has the necessary controls to support manufacturing of potent solid oral dosage forms. PPS intends to offer high potency drug manufacturing capabilities at the site, complementing the Company’s global strength in highly potent compounds. The site employs a highly knowledgeable and experienced workforce of ~100, with an average of 19 years of service with the site. PPS expects to further grow the site’s current strength to support development services as well as any COVID-19 management drug opportunities. Expanding the PPS service offerings directly supports the Company’s philosophy of Patient Centricity. Understanding the needs of patients and building an organization that is dedicated to addressing those needs is the foundation of Patient Centricity. By putting patients first, PPS is aligning its mission with that of its customers, becoming better partners who share a common goal. ]]> <![CDATA[Glenmark unveils FabiFlu for COVID-19 treatment]]> https://biospectrumindia.com/news/95/16712/glenmark-unveils-fabiflu-for-covid-19-treatment.html https://biospectrumindia.com/news/95/16712/glenmark-unveils-fabiflu-for-covid-19-treatment.html Sun, 21 Jun 2020 10:30:00 +0530 In a landmark development for COVID-19 patients in India, Mumbai based Glenmark Pharmaceuticals, a research-led, integrated global pharmaceutical company, has announced the launch of antiviral drug Favipiravir (brand name FabiFlu®) for the treatment of mild to moderate COVID-19 patients. Glenmark has received manufacturing and marketing approval from India’s drug regulator, making FabiFlu® the first oral Favipiravir-approved medication in India for the treatment of COVID-19. Favipiravir is backed by strong clinical evidence showing encouraging results in patients with mild to moderate COVID-19. The antiviral offers broad spectrum RNA virus coverage with clinical improvement noted across age groups 20 to >90 years. Favipiravir can be used in COVID-19 patients with co-morbid conditions such as diabetes and heart disease with mild to moderate COVID 19 symptoms. It offers rapid reduction in viral load within 4 days and provides faster symptomatic and radiological improvement.Of most importance, Favipiravir has shown clinical improvement of up to 88% in COVID-19 mild to moderate COVID 19 cases. Glenmark successfully developed the active pharmaceutical ingredient (API) and the formulation for FabiFlu® through its own in-house R&D team. Glenmark filed the product for clinical trial with India’s drug regulator DCGI and became the first pharmaceutical company in India to receive approval for conducting phase 3 clinical trial on mild to moderate COVID-19 patients. Most patients exhibiting mild to moderate symptoms can benefit from FabiFlu® use. The drug will be available as a prescription-based medication for INR 103/tablet, with recommended dose being 1800 mg twice daily on day 1, followed by 800 mg twice daily up to day 14. ]]> <![CDATA[Understanding practical approaches towards FDA investigations]]> https://biospectrumindia.com/news/95/16698/understanding-practical-approaches-towards-fda-investigations.html https://biospectrumindia.com/news/95/16698/understanding-practical-approaches-towards-fda-investigations.html Fri, 19 Jun 2020 14:00:00 +0530 Mumbai based BlueTech Media is organising a training programme on investigation, root cause analysis, risk assessment & CAPA on 23 and 24 June, 2020. The training will be conducted by Hitendra Kumar Sharma, CEO of NADH+ GXP Compliance Services, a Member of American Society for Quality & Indian Pharmaceutical Association   WORKSHOP OVERVIEW: It has been observed that one of the most common FDA 483 and Warning Letter citations continues to be inadequate investigations, Root Cause Analysis, CAPA & Risk assessment. The FDA uses the investigation reports and investigation trends to identify potential quality problems and action plan taken in all areas of the company. Ultimately, inadequate investigations can lead to 483 citations, Warning Letters, release of sub-standard product, or product recall. Furthermore, costly and time-consuming system remediation may be required. Having a procedure on Investigations, Root Cause analysis, CAPA & Risk assessment is not enough. It is the strategy, content, extent of efforts made and conclusions that truly count. This training will help attendees understand the fundamental steps, practical approach towards investigations, Root Cause analysis, CAPA and proactive approach as well as reactive approach of risk assessment. Key focus will be put on practical examples, implementation & compliance practices with respect to current guideline requirements, FDA citations and learning from observations.   BENEFITS OF ATTENDING THE WORKSHOP: 1. Skill shall be developed for formal investigation & risk assessment, how to arrive on root cause, what are the practical approach for CAPA2. During the course of workshop, participants will understand the easy, pragmatic and cost effective approaches to compliance3. The attendees will learn what are the current oversight about these topics, how they can be in compliance with respect to different guideline requirement4. Management and Oversight on the investigation, risk assessment & the CAPA system and its documentation5. Acquire new and enhanced skills in finding multiple root cause6. Methods to reduce & avoid human error7. Attendees will be able to understand the different types of investigations tools8. To avoid release of sub-standard product & product recall9. This training would enable attendees to overcome most common FDA 483 and Warning Letter citations caused due to inadequate investigations, Root Cause analysis, CAPA & Risk assessment      ]]> <![CDATA[Naari acquires ANDAs From Intas Pharma]]> https://biospectrumindia.com/news/95/16697/naari-acquires-andas-from-intas-pharma.html https://biospectrumindia.com/news/95/16697/naari-acquires-andas-from-intas-pharma.html Fri, 19 Jun 2020 00:00:00 +0530 Naari Pharma Private Limited has entered into a definitive asset purchase agreement to acquire 10 Abbreviated New Drug Applications (ANDAs) for the U.S. market from Intas Pharmaceuticals Ltd. The portfolio acquired comprises eight U.S. FDA approved ANDAs and two products pending approval. It includes generic products in female hormones which will be manufactured at Naari's dedicated female hormone facility in India and commercialized over the next 24 months. Naari is a vertically integrated global women's health pharmaceutical business focused on hormones and has development and manufacturing capabilities across intermediates, active pharmaceutical ingredients, and finished dosage forms (FDFs). Prithi S Kochhar, Co-Founder and CEO of Naari, said: "This is great news for us and another milestone in our journey towards becoming a leading global player in the field of women's health. This is an important step towards developing our U.S. portfolio. "With these newly acquired ANDAs we now have market access of USD 900 million as per IQVIA data." The acquisition follows a planned period of significant growth and investment for Naari. In October 2019 Naari acquired three ANDAs from OC Pharm in the U.S. and in February 2020 the company announced that it had received an equity investment of USD 17.5 million from Ascent Capital, a leading India-focused growth capital provider. Prithi S Kochhar continued: "Our journey into the U.S. market is well charted and we expect sales and a positive growth trajectory beginning in the next 12 months. "We now have all the key enablers in place towards achieving our revenue target of USD 100 million in the next 4-5 years, which should make us one of the top women's health companies in the world and enable us to continue providing vital products to support women's health across the globe." With a presence in more than 50 countries and over 30 hormonal generics currently available or under development, Naari has one of the most comprehensive hormonal portfolios in the world.   ]]> <![CDATA[Roche Pharma India, Entero Healthcare focus on nephrology medicines]]> https://biospectrumindia.com/news/95/16688/roche-pharma-india-entero-healthcare-focus-on-nephrology-medicines.html https://biospectrumindia.com/news/95/16688/roche-pharma-india-entero-healthcare-focus-on-nephrology-medicines.html Thu, 18 Jun 2020 11:00:00 +0530 Roche Products (India) Pvt. Ltd. (Roche Pharma) and Entero Healthcare Solutions Pvt. Ltd. (Entero) have announced that the two companies have entered into an agreement to provide better access to innovative medicines for patients in India. Under this agreement, Entero will be responsible for promotion, marketing and distribution of Roche Pharma’s key nephrology drugs viz., Mycophenolate Mofetil (Cellcept), Valganciclovir (Valcyte), Epoetin Beta (NeoRecormon), and Methoxy Polyethylene Glycol-epoetin Beta (Mircera) in India.  Roche Products (India) Pvt. Ltd. has been taking multiple steps to increase the reach of their innovations in India. The company is expanding its presence in different states in India by increasing its field force in a phased manner and investing in new talent in India over the next few months. The partnership deal, the discussions for which has been going on for the last few months, will help the company focus on these states and capabilities.Currently, the company has more than 2000 people working across states and through various partners in India. “While we keep working towards creating and enhancing the healthcare ecosystem in India, we need to differentiate between our existing products that can reach the patients at a faster pace through a valued partnership like this, and the newer innovative drugs that we can focus on bringing into India in next few years.” said V. Simpson Emmanuel, General Manager, Roche Products (India) Pvt. Ltd.”At Roche Pharma India, we are focusing on strategic approaches to ensure robust access, better healthcare financing and overall enhanced healthcare ecosystem. A partnership in India for our Nephrology portfolio is one such important step in ensuring that we bring world-class medicines and healthcare solutions to our country through an esteemed partner like Entero Healthcare Solutions.We remain committed to transforming healthcare in India to become a benchmark for other emerging markets around the globe.” Prabhat Agrawal, Co-founder and CEO, Entero Healthcare Solutions Pvt. Ltd. said, “We are delighted to enter this unique collaboration with Roche to be able to serve patient needs in the area of organ transplant and chronic kidney disease. There has been a significant rise in the number of patients with kidney related ailments and with Entero’s presence across major cities in India, we aspire to make these innovative set of medicines accessible to every patient.” ]]> <![CDATA[ICT, Lasa realise success in Favipiravir drug synthesis]]> https://biospectrumindia.com/news/95/16692/ict-lasa-realise-success-in-favipiravir-drug-synthesis.html https://biospectrumindia.com/news/95/16692/ict-lasa-realise-success-in-favipiravir-drug-synthesis.html Thu, 18 Jun 2020 00:00:00 +0530 Veterinary API Major, Lasa Supergenerics, and Institute of Chemical Technology had come together in the month of March 2020 in an effort to bring the antiviral to the market as a promising therapy to fight the ongoing Covid-19 pandemic. Commenting on the development, Dr. Omkar Herlekar, Chairman– Lasa Supergenerics Limited, said Efforts over the last few months has brought success and we are looking to manufacture close to 10,000 doses, to begin with, and in the meanwhile also apply for the drug license with competent authorities and continue to seek strategic private investments or Government aid. Our move into human steroid API is in line with the organization's inherent strengths and objectives to diversify. Commenting on the antivirals successful synthesis, Prof. Vikas N Telvekar, ICT, Mumbai, said we are happy to share with you that the Favipiravir molecule has been successfully synthesized in the ICT laboratory on a lab-scale and further pilot plan scale-up is required.” Recently in its Q4 results, the company reported a healthy increase in its PAT to Rs 3.63 cr for FY20, as compared to a loss of Rs 12.04 cr in the corresponding period last fiscal.   ]]> <![CDATA[Zydus signs deal with Gilead to manufacture, market remdesivir]]> https://biospectrumindia.com/news/95/16671/zydus-signs-deal-with-gilead-to-manufacture-market-remdesivir.html https://biospectrumindia.com/news/95/16671/zydus-signs-deal-with-gilead-to-manufacture-market-remdesivir.html Tue, 16 Jun 2020 10:00:00 +0530 Zydus Cadila, an innovation-driven, global healthcare company has announced that it has signed a non-exclusive licensing agreement with Gilead Sciences Inc., for the manufacturing and distribution of Remdesivir, the investigational drug, which has been issued an Emergency Use Authorization by the U.S. Food and Drug Administration (FDA) to treat patients suffering from severe symptoms of Novel Coronavirus. Zydus has been supporting the fight against COVID 19 with therapeutics, vaccines and diagnostics. Speaking on the development, Chairman of Zydus, Mr. Pankaj Patel said, “We are happy to collaborate with Gilead Sciences and increase the access to this life saving drug for patients suffering from COVID 19. Over the last decade, we have been partnering with Gilead Sciences to address various public healthcare challenges and improve global access to affordable need-based therapies. At this critical juncture, we join hands once again to ensure that no efforts are spared in the fight against this pandemic.” As part of the non-exclusive agreement, Zydus will receive the manufacturing know-how from Gilead Sciences Inc., to manufacture the API for Remdesivir and the finished product and market it in 127 countries, including India. Under the agreement, the license is royalty free until another pharmaceutical product or vaccine is approved for the treatment or prevention of COVID 19 by the USFDA or EMA or the WHO announcing the end of the public health emergency. Zydus will leverage its ability to scale up production to reach patients across India and across the 127 countries in Gilead’s Global Patient Solution region. The safety and efficacy of remdesivir to treat COVID-19 are being evaluated in multiple ongoing Phase 3 clinical trials. ]]> <![CDATA[Sun Pharma offers psoriasis treatment to Middle East, North Africa]]> https://biospectrumindia.com/news/95/16674/sun-pharma-offers-psoriasis-treatment-to-middle-east-north-africa.html https://biospectrumindia.com/news/95/16674/sun-pharma-offers-psoriasis-treatment-to-middle-east-north-africa.html Tue, 16 Jun 2020 10:00:00 +0530 Sun Pharmaceutical Industries Ltd. has announced that one of its wholly-owned subsidiaries and Hikma Pharmaceuticals PLC (Hikma) have entered into an exclusive licensing and distribution agreement for ILUMYA™, an innovative biologic product, for the Middle East & North Africa (MENA) region. ILUMYA™ (tildrakizumab) is an USFDA approved innovative IL-23p19 monoclonal antibody used for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. Under the terms of the licensing agreement, Hikma will be responsible for the registration and commercialization of the product in all MENA markets and Sun Pharma will be responsible for product supply. Sun Pharma is eligible for upfront and milestone payments from Hikma. The term of this agreement is 15 years from first sale, with two years’ automatic renewal periods. Aalok Shanghvi, Senior Vice President - Emerging Markets, Sun Pharma said, “We are pleased to partner with Hikma to offer ILUMYA™ to patients in the MENA region. Hikma’s strong presence in the MENA region will enable access to a new treatment option for people who are unable to manage their moderate-to-severe plaque psoriasis.” ]]> <![CDATA[Dr. Reddy's inks agreement with Gilead for remdesivir]]> https://biospectrumindia.com/news/95/16666/dr-reddys-inks-agreement-with-gilead-for-remdesivir.html https://biospectrumindia.com/news/95/16666/dr-reddys-inks-agreement-with-gilead-for-remdesivir.html Mon, 15 Jun 2020 08:00:00 +0530 Hyderabad based Dr. Reddy's Laboratories Ltd. has announced that it has entered into a non-exclusive Licensing Agreement with Gilead Sciences, Inc. (Gilead) that will grant Dr. Reddy’s the right to register, manufacture and sell Gilead’s investigational drug, Remdesivir, a potential treatment for Covid-19, in 127 countries including India. Dr. Reddy’s will receive technology transfer from Gilead for manufacturing of this drug. Dr. Reddy’s would need to do the manufacturing scale up and obtain regulatory approval for marketing of this drug in respective countries. Remdesivir, an investigational antiviral therapy developed by Gilead, received Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration (USFDA) to treat Covid-19. ]]> <![CDATA[Sun Pharma offering new solutions for treating skin cancer]]> https://biospectrumindia.com/news/95/16662/sun-pharma-offering-new-solutions-for-treating-skin-cancer.html https://biospectrumindia.com/news/95/16662/sun-pharma-offering-new-solutions-for-treating-skin-cancer.html Sun, 14 Jun 2020 17:05:00 +0530 Sun Pharmaceutical Industries Ltd. has announced that one of its wholly-owned subsidiaries presented data analyses for two of its specialty medicines – ODOMZO® (sonidegib) and LEVULAN® KERASTICK® (aminolevulinic acid HCl) + BLU-U ® – from its dermatology portfolio, providing insights to healthcare providers treating patients who have or are at risk for different types of skin cancer. These data analyses were presented at the American Academy of Dermatology (AAD) Virtual Meeting Experience 2020, June 12-June 14 ODOMZO, a hedgehog inhibitor, is used to treat adults with locally advanced basal cell carcinoma (laBCC) that has returned following surgery or radiation or that cannot be treated with surgery or radiation. Long-term analyses of the BOLT study confirmed that treatment with ODOMZO provided clinically meaningful outcomes to patients with laBCC who were taking common concomitant medicines, such as medicines for cardiovascular, inflammatory and auto-immune diseases. The safety profile for ODOMZO in these patients who were an average age of 67 years old was manageable and consistent with overall findings from the BOLT study.  LEVULAN KERASTICK for topical solution, 20%, plus blue light illumination using the BLU-U Blue Light Photodynamic Therapy Illuminator is used to treat minimally to moderately thick actinic keratoses of the face, scalp or upper extremities, which the Skin Cancer Foundation classifies as precancerous skin growths that if left untreated may turn into squamous cell carcinoma. While only about 10% of actinic keratoses become cancerous, the majority of squamous cell carcinoma cases start as actinic keratoses.   ]]> <![CDATA[Eris Lifesciences brings Boman Irani as brand ambassador for Circa]]> https://biospectrumindia.com/news/95/16657/eris-lifesciences-brings-boman-irani-as-brand-ambassador-for-circa.html https://biospectrumindia.com/news/95/16657/eris-lifesciences-brings-boman-irani-as-brand-ambassador-for-circa.html Sat, 13 Jun 2020 00:00:00 +0530 Eris Lifesciences has announced association with the well-known theatre and film actor, Boman Irani, for their circa range of devices. The association is aimed at highlighting importance of an accurate and validated BP monitoring device. The focus of the campaign is to encourage hypertensive patients to measure their blood pressure at home using a validated device while making an appeal to share their readings with doctor. The campaign theme #ShareYourPressure, urges users to stop worrying about getting false reading and trust the device to share their pressure. Sharing his comments on the partnership, Boman Irani said, “It gives me immense pleasure to start this journey with Circa. For blood pressure management, the latest norms require a person to monitor it at least 2 times a day in the morning and evening. With technology advancing manifolds, it is only important for us to bring the same into our healthcare systems and adopt validated devices that can provide timely updates when required.” Commenting on the development, Amit Bakshi, Chairman and Managing Director, Eris Lifesciences said, “Hypertension therapy is our second largest therapy and with cardiovascular being the No. 1 Chronic therapy, we are upping our ante by closing the loop with one of the most validated device for blood pressure management. We have world class data in the form of ‘India Heart Study’ conducted on the same ‘Circa’ device further validating our commitment to Hypertension therapy.With Boman Irani on board, we feel this partnership with the brand will increase awareness around Home Blood pressure monitoring (HBPM) and bring more people to target Blood pressure.”   ]]> <![CDATA[Hula Global expands PPE portfolio with face shields ]]> https://biospectrumindia.com/news/95/16658/hula-global-expands-ppe-portfolio-with-face-shields-.html https://biospectrumindia.com/news/95/16658/hula-global-expands-ppe-portfolio-with-face-shields-.html Sat, 13 Jun 2020 00:00:00 +0530 After building the capacity to produce near to a million medical coveralls during the ongoing lockdown, Noida based manufacturer & distributor of medical PPE gears Hula Global has introduced protective face shields for those associated with service industries, including restaurants, retailers, salons, grocery stores, food plants as well as the medical sector. With Prime Minister Narendra Modi raising a clarion call to the nation to go ‘Vocal for Local’, homegrown firms like Hula Global, which started the PPE manufacturing with coveralls under its brand name ULTRA has augmented its product offering with a broad range of PPE garments, including a variety of gloves, masks, etc. While the newly launched face shields are designed for the medical and service industry, they are available to the general public, too. Speaking on the launch, Mr. Karan Bose, MD, Hula Global said, “The demand for facial protection is rising rapidly as the government is finally moving towards unlocking the country. Along with shielding the front-line healthcare workers, we are now receiving inquiries from other service sectors as well. Our face shields have been designed to not only protect the customers but also make them feel comfortable once they step out of their homes for their respective businesses.” Having acquired deep knowledge and expertise in the manufacturing of medical-grade products since its inception in Dec 2018, Hula Global has been aggressively emphasizing manufacturing PPE gears to deal with the global COVID-19 crisis. Today, its brand, ULTRA Uniforms is the only Indian PPE and coverall brand that has been approved by the Bahrain government. With approvals from the government of Saudi Arabia and Iran as well, the firm has already established distributors of ULTRA in the countries. It is now awaiting the export ban to be lifted so that the shipping procedure to these countries can be conducted.  ]]> <![CDATA[Biocon, Mylan receive FDA approval of Insulin Glargine]]> https://biospectrumindia.com/news/95/16647/biocon-mylan-receive-fda-approval-of-insulin-glargine.html https://biospectrumindia.com/news/95/16647/biocon-mylan-receive-fda-approval-of-insulin-glargine.html Fri, 12 Jun 2020 10:00:00 +0530 Biocon Ltd. and Mylan N.V. have announced that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application (NDA) for Semglee™ (insulin glargine injection), in vial and pre-filled pen presentations, to control high blood sugar in adults with type 2 diabetes and adult and pediatric patients with type 1 diabetes.  Semglee has an identical amino acid sequence to Sanofi’s Lantus® and is approved for the same indications. Semglee, co-developed by Mylan and Biocon Biologics, was approved as a drug product under the 505(b)(2) NDA pathway and is now deemed a biologic under section 351(a) in accordance with the Biologics Price Competition and Innovation Act in line with other insulin products. Kiran Mazumdar Shaw, Chairperson, Biocon, said: “The approval of our insulin glargine by the U.S. FDA marks the culmination of a long journey. As an organisation committed to making insulin-based therapy increasingly accessible for people with diabetes globally, I am glad this approval will enable us to serve the needs of patients in the U.S. The approval is also an endorsement of our science, scale and expertise to develop high quality, more affordable insulins and shift the access paradigm in favour of patients, taking us closer to realizing our aspiration of reaching ‘one in five’ insulin dependent people with diabetes worldwide.” The approval for Semglee was based on a comprehensive analytical, preclinical and clinical program (including the INSTRIDE studies) which confirmed the PK/PD, efficacy, safety and immunogenicity of Semglee in comparison to Lantus in patients with type 1 and type 2 diabetes. ]]> <![CDATA[Excelra releases COVID-19 biomarker database]]> https://biospectrumindia.com/news/95/16652/excelra-releases-covid-19-biomarker-database.html https://biospectrumindia.com/news/95/16652/excelra-releases-covid-19-biomarker-database.html Fri, 12 Jun 2020 00:00:00 +0530 Hyderabad based Excelra, a leading global data-analytics company has announced the release of the COVID-19 Biomarker Database (https://www.excelra.com/covid-19-biomarker- database/) in support of the ongoing global scientific efforts, aimed at developing safe and effective therapeutic options to treat the novel coronavirus disease. This  resource is excerpted from Excelra’s GOBIOM platform -  the worlds largest biomarker intelligence database. With reference to this endeavour, Dr. Raveendra Dayam, Director, Chemistry and Biology Data Services, Excelra, said, “The COVID-19 Biomarker Database is a compilationof manually curated biomarkers from published clinical trials, evaluating potential drugs or biologics for the treatment of SARS-CoV-2. The database additionally includes information on FDA-NIH recommended BEST (Biomarkers, EndpointS and other Tools) classification of biomarkers, supported with referenced literature.” The information in the COVID-19 Biomarker Database is presented in a user-friendly online application and the data is regularly updated with new biomarkers from clinical trials published in clinicaltrials.gov. Excelra’s GOBIOM is the world’s largest manually curated database of validated and putative biomarkers, providing a comprehensive overview of the biomarker-disease relationship. Integrated with information encompassing the exploratory, preclinical and clinical domains, the database provides critical insights into diagnosis, prognosis, treatment response, safety, efficacy and toxicity. As a one-stop source for biomarker intelligence, GOBIOM enables informed clinical and therapeutic decision making to accelerate drug development. ]]> <![CDATA[Panacea Biotec, Refana announce landmark collaboration for COVID-19 vaccine]]> https://biospectrumindia.com/news/95/16634/panacea-biotec-refana-announce-landmark-collaboration-for-covid-19-vaccine.html https://biospectrumindia.com/news/95/16634/panacea-biotec-refana-announce-landmark-collaboration-for-covid-19-vaccine.html Wed, 10 Jun 2020 10:10:00 +0530 New Delhi based Panacea Biotec is advancing its response to address the unprecedented challenges of COVID-19 by collaborating with Refana Inc. USA to make candidate Covid-19 vaccine widely accessible around the world in an equitable manner through a Joint Venture company based in Ireland. The collaboration aims to bring to patients a whole inactivated virus-based vaccine for Covid-19. Under the collaboration, Panacea Biotec will be responsible for product development and commercial manufacturing, with the Joint Venture undertaking clinical development and regulatory submissions across the World. Both Panacea and Refana will undertake sales and distribution of the vaccine in their respective territories. Dr. Rajesh Jain, Managing Director, Panacea Biotec, said, “The world needs a vaccine that is safe, effective, and scalable in a cGMP compliant manufacturing facility that has sizeable capacity and capability to cater to global demand. Our collaboration with Refana aims to manufacture over 500 million doses of our Covid-19 candidate vaccine, with over 40 million doses expected to be available for delivery early next year. Our candidate vaccine is based on tried and tested technologies that have been proven over decades with existing vaccines. Whole inactivated viral vaccines have a higher probability of being safe and efficacious, given their long history and better understanding of their mechanism of action, which has been elucidated over many decades. Our vaccine leverages a dose-sparing Adjuvant to maximise the number of immunisations available for distribution. Additionally, intramuscular/sub-cutaneous mode of administration with pre-existing, compatible infrastructure ensures adequate supply chain availability until the last mile. This vaccine has the potential to become the Vaccine of Choice for the global fight against Covid-19. We believe and hope that our vaccine candidate will enable the world to get back to work fearlessly as soon as possible.” Dr Phillip Schwartz stated "Refana and its international network of scientific researchers and practitioners are dedicated to finding practical solutions to complex and urgent global medical problems. We are grateful for the input we have obtained from dozens of medical scientists and epidemiologists in more than a dozen countries in this unprecedented worldwide collaboration to end Covid-19. Our partnership with Panacea Biotec brings this dream to a practical realization with the ability to manufacture 500 million Covid-19 vaccines over 12 months. Utilizing proven models of viral pathogenesis and parallel conduct of multiple pre-clinical and clinical studies, Refana believes it can significantly accelerate the vaccine development and approval process for its tried and true whole inactivated viral vaccine approach. We are very excited to combine this approach with Panacea Biotec’s world class technology, development and production capabilities." This collaboration brings together the Panacea Biotec’s expertise in vaccinology, R&D, manufacturing and distribution capabilities with Refana’s Scientific team’s strong ability to work on complex challenges through innovative technologies. We believe that by joining forces, we can accelerate the globalisation of a vaccine to combat the virus and protect people from most contagious virus in more than a century. ]]> <![CDATA[Sun Pharma initiates Ph II trial on AQCH for COVID-19 treatment]]> https://biospectrumindia.com/news/95/16619/sun-pharma-initiates-ph-ii-trial-on-aqch-for-covid-19-treatment.html https://biospectrumindia.com/news/95/16619/sun-pharma-initiates-ph-ii-trial-on-aqch-for-covid-19-treatment.html Mon, 08 Jun 2020 07:15:00 +0530 Sun Pharmaceutical Industries Ltd. has announced that it has commenced Phase II clinical trial on AQCH, a phytopharmaceutical (plant derived) drug for treatment of COVID-19. The Company received approval from the Drugs Controller General of India (DCGI) for conducting Phase II clinical trial in April this year. The clinical trial will be conducted across 12 centers in India in 210 patients. The treatment duration for patients will be 10 days. The results of the clinical trial are expected by October 2020. Human safety study of AQCH has already been completed and the drug has been found safe at the recommended dose for Phase II study. Dilip Shanghvi, Managing Director, Sun Pharma said, “This is the first phytopharmaceutical drug approved for clinical trials by the DCGI as a potential treatment for COVID-19. AQCH has shown anti-SARS-CoV-2 effects in in-vitro studies conducted in collaboration with ICGEB, Italy. These results combined with information on mechanism of action through in-vitro and small animal studies give us the confidence to evaluate this potential treatment option for COVID-19 patients.” AQCH, which is being developed for dengue, has shown broad antiviral effect in in vitro studies and hence is being tested as a potential treatment option for COVID-19. Since 2016, Sun Pharma has been working very closely with DBT-ICGEB, under the leadership of Dr. Navin Khanna and CSIR-IIIM, under the leadership of Dr. Ram Vishwakarma, to develop a phytopharmaceutical drug for dengue. The work on evaluation of plant-derived drugs for the treatment of dengue started in 2007 under the auspices of the Department of Biotechnology’s (DBT) Task Force on Medicinal and Aromatic Plants. Dr. Renu Swarup, Secretary of Department of Biotechnology, Ministry of Science and Technology, stated “Our efforts to develop a safe, effective and affordable drug against dengue started about 13 years ago. The collaborating team quickly initiated studies for the development of a drug against COVID-19. I wish the collaborating team success in the conduct of the clinical trial against COVID-19 and for the development of phytopharmaceutical drugs against other infectious diseases.” Dr Shekhar C Mande, Director General, CSIR commented that “CSIR has had a long-standing association with the pharmaceutical industry in India and welcomes this collaboration with Sun Pharma in taking forward AQCH into clinical trials for COVID-19 patients. This collaboration aligns with our scientific rationale for the quickest way to develop drugs against SARS-CoV-2”. ]]> <![CDATA[CEPI grants $14.1M to Bharat Biotech, IVI for advancing Chikungunya vaccine]]> https://biospectrumindia.com/news/95/16601/cepi-grants-14-1m-to-bharat-biotech-ivi-for-advancing-chikungunya-vaccine.html https://biospectrumindia.com/news/95/16601/cepi-grants-14-1m-to-bharat-biotech-ivi-for-advancing-chikungunya-vaccine.html Thu, 04 Jun 2020 06:10:00 +0530 CEPI, the Coalition for Epidemic Preparedness Innovations, in collaboration with Ind-CEPI, has announced a new partnering agreement with a consortium comprising Bharat Biotech (BBIL) and the International Vaccine Institute (IVI) to advance the development of a Chikungunya vaccine. CEPI will fund the consortium with up to $14.1 million for vaccine manufacturing and clinical development of a two-dose live-inactivated vaccine (BBV87) against Chikungunya. This grant is supported by the European Union’s (EU’s) Horizon 2020 programme through an existing framework partnership agreement with CEPI. The consortium will be further supported with a grant of up to $2 million from the Indian Government’s Ind-CEPI initiative which will fund the set-up of GMP manufacturing facilities for the vaccine in India, and the subsequent manufacture of clinical trial materials. In addition to manufacturing, the partnering agreement will finance a multi-centre Phase 2/3 adaptive clinical trial to be conducted by IVI in Colombia, Panama and Thailand which will provide crucial data about the safety and immunogenicity of the vaccine candidate. The partnership will build on BBIL’s experience of developing and supplying affordable vaccines, and WHO prequalification procedures, to ensure affordable access to the vaccine in countries where Chikungunya is endemic, in line with CEPI’s core commitment to equitable access. The investment is part of CEPI’s third call for proposals which was launched in January 2019. Since the launch of this call, over $80 million of CEPI core funding has been committed to three Chikungunya vaccine candidates and two Rift Valley Fever vaccine candidates. BBIL’s BBV87 vaccine is an inactivated whole virion vaccine based on a strain derived from an East, Central, South African (ECSA) genotype. The vaccine has completed standard pre-clinical studies, and an optimum immune response was elicited by the adjuvanted vaccine in phase 1 clinical trials in India. Inactivated virions technology has a safety profile which potentially makes this vaccine accessible to special populations, such as the immunocompromised and pregnant women, that some other technologies cannot reach. Dr. Krishna Ella, Chairman and Managing Director of Bharat Biotech said, “We are immensely proud to be part of this esteemed alliance to bring to the world a safe and effective solution against the debilitating Chikungunya infection. At Bharat Biotech, we have always been at the forefront of innovation while developing vaccines for neglected diseases such as Typhoid and re-emerging epidemics such as Zika, H1N1 and Japanese Encephalitis. We are hopeful that with accelerated clinical development in endemic countries, the candidate CHIK vaccine will be successful. “We are witnessing that today’s neglected diseases are susceptible to become tomorrow’s pandemics and with this collaboration we have the opportunity to tackle them proactively,” he added.   ]]> <![CDATA[Lupin and Mylan receive EC marketing approval for Nepexto]]> https://biospectrumindia.com/news/95/16610/lupin-and-mylan-receive-ec-marketing-approval-for-nepexto.html https://biospectrumindia.com/news/95/16610/lupin-and-mylan-receive-ec-marketing-approval-for-nepexto.html Thu, 04 Jun 2020 00:00:00 +0530 Lupin Limited (Lupin) and Mylan N.V. have announced that the European Commission (EC) has granted marketing authorization for Nepexto®, a biosimilar to Enbrel® (etanercept), for all indications of the reference product including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, axial spondyloarthritis (including ankylosing spondylitis and non-radiographic axial spondyloarthritis), plaque psoriasis and paediatric plaque psoriasis. The regulatory approval follows the adoption of a positive opinion by the Committee for Medicinal Products for Human Use (CHMP) in March this year, which was based on a biosimilarity assessment including preclinical and clinical studies demonstrating bioequivalence to Enbrel. In addition, a phase 3 clinical study in patients with moderate-to-severe active rheumatoid arthritis confirmed equivalence of Nepexto to Enbrel in terms of efficacy, safety and immunogenicity.  The centralized marketing authorization applies to all member countries of the European Union.  Vinita Gupta, CEO, Lupin Limited said, “We are truly delighted with this approval. Nepexto is our first biosimilar to receive regulatory approval in Europe. With this important milestone, we bring an affordable biosimilar to the European market through our partner Mylan. Biosimilars like Nepexto will play a critical role in expanding access to patients in Europe, providing an effective treatment for multiple therapies including rheumatoid arthritis.” Mylan President, Rajiv Malik commented, “The approval of Nepexto, our biosimilar etanercept, is a positive step forward as we work to broaden our biosimilars franchise offerings and do our part to increase access to biologic treatments for patients in many European countries. This milestone reflects a strong scientific program behind Nepexto and commitment by our teams and our partner, Lupin, to bring the product to market as soon as possible. We look forward to launching Nepexto in the second half of this year.”  Enbrel had sales of approximately $9.6 billion globally for the 12 months ending December 2019, according to IQVIA.In June 2018, Lupin and Mylan announced a collaboration to commercialize a biosimilar to etanercept in several global markets.  ]]> <![CDATA[Lupin signs distribution agreement for orphan drug NaMuscla]]> https://biospectrumindia.com/news/95/16598/lupin-signs-distribution-agreement-for-orphan-drug-namuscla.html https://biospectrumindia.com/news/95/16598/lupin-signs-distribution-agreement-for-orphan-drug-namuscla.html Wed, 03 Jun 2020 11:15:00 +0530 Pharma major Lupin Limited has announced that it has entered into distribution agreement with three companies for its orphan drug NaMuscla (mexiletine). Exeltis Healthcare S.L, Cresco Pharma B.V and Macure Pharma ApS will commercialize NaMuscla for the symptomatic treatment of myotonia in adults with non-dystrophic myotonic (NDM) disorders in certain EU territories. NaMuscula is the first and only licensed product for this indication. NDM disorders are a group of rare, inherited neuromuscular disorders which cause the inability to relax muscles following voluntary contraction. NaMuscla reduces myotonia symptoms in adult patients, resulting in a significant improvement in patient quality-of-life and other functional and clinical outcomes. NaMuscla, which has been designated orphan drug status, received EU marketing authorization in December 2018. Under the agreements announced, Exeltis Healthcare S.L will commercialize NaMuscla in Spain and Portugal, Cresco Pharma B.V will commercialize NaMuscla in the Netherlands and Macure Pharma ApS in the Nordic countries. Lupin will continue commercialization of NaMuscla in Germany and UK and will launch the product in Austria and France later this year. Thierry Volle, President EMEA, Lupin said, “These distribution agreements represent an important milestone for Lupin as we roll out commercialization of NaMuscla® across Europe. Collaborating with partners that are highly effective in their focus territories ensures patients will receive the drug in as effective manner as possible. Lupin is committed to addressing the unmet needs of patients with NDM through the establishment of country-specific solutions and to ensuring patient access across Europe in alignment with national health authorities, healthcare providers and patient advocacy groups.” Today, more than 7,500 people in Europe living with NDM have limited access to a licensed treatment for myotonia that can reduce the daily burden of this disabling, lifelong symptom. Limited access leads to inconsistent medication supply, administrative challenges and associated financial burdens, which, along with low awareness and limited clinical experience among healthcare professionals due to rare nature of disease, may result in significant harm to patients. Lupin recently obtained approvals to begin a paediatric trial as part of the paediatric investigation plan for NaMuscla and a post authorization [safety] study to address long-term safety and treatment efficaciousness on patient reported outcomes. Both trials will begin later this year.   ]]> <![CDATA[SPARC, Sun Pharma move SCD-044 to Ph 2 trials]]> https://biospectrumindia.com/news/95/16573/sparc-sun-pharma-move-scd-044-to-ph-2-trials.html https://biospectrumindia.com/news/95/16573/sparc-sun-pharma-move-scd-044-to-ph-2-trials.html Mon, 01 Jun 2020 07:30:00 +0530 Sun Pharma Advanced Research Company Ltd. (SPARC) and Sun Pharmaceutical Industries Ltd. have announced a worldwide licensing agreement on the development and commercialization of SCD-044 which is being evaluated as a potential oral treatment for atopic dermatitis, psoriasis and other auto-immune disorders. SCD-044 is entering phase 2 clinical trials. Under terms of the license agreement, Sun Pharma will pay SPARC an upfront payment of US$ 20 million. SPARC will also be eligible to receive up to US$ 125 million as milestone payments contingent upon the achievement of clinical, regulatory and sales milestones, as well as tiered royalties on sales. Sun Pharma will be responsible for the development, regulatory filings, manufacturing and commercialization of the product globally. “SPARC is committed to progressing its pipeline to address the needs of patients. We are proud to be partnering with a global organization with a footprint in auto-immune disorders” said Anil Raghavan, CEO, SPARC. This agreement with Sun Pharma follows the recent announcement that SPARC has acquired Bioprojet SCR’s share of rights to SCD-044. “The in-licensing of SCD-044 adds to our specialty pipeline of innovative dermatology products. It also demonstrates our commitment to this important segment with significant unmet medical needs. SCD-044 may offer an alternate treatment option for patients in this segment who require systemic treatment and may offer benefits in terms of efficacy and safety over existing oral treatments for this population. SCD-044 has the potential to improve the current oral standard of care.” said Dilip Shanghvi, Managing Director, Sun Pharma. SCD-044 is a novel orally bio-available Sphingosine-1-P (S1P1) receptor agonist for the treatment of inflammatory diseases such as atopic dermatitis and psoriasis. S1P1 receptor agonists are promising for the treatment of autoimmune inflammatory diseases as they cause diminished migration of lymphocytes out of lymphatic tissue. This results in a decrease of circulating lymphocytes, thereby reducing inflammation. The phase 1 study of SCD-044 has been completed in healthy volunteers. This study established clinical proof-of-concept for SCD-044 in terms of its pharmacodynamics effects. Lymphocyte count reduction, a surrogate marker of efficacy for S1P1R agonists was observed at all dose levels evaluated ]]> <![CDATA[Bayer celebrates 60 Years of progress in empowering women]]> https://biospectrumindia.com/news/95/16579/bayer-celebrates-60-years-of-progress-in-empowering-women.html https://biospectrumindia.com/news/95/16579/bayer-celebrates-60-years-of-progress-in-empowering-women.html Mon, 01 Jun 2020 00:00:00 +0530 On the International Day of Action for Women’s Health, Bayer is celebrating the 60th anniversary of the Contraceptive Pill that has impacted millions of women across the globe. This pill has opened a world of opportunity by giving women and couples the right to have a child by choice, not chance. It has enabled women of different generations to engage in a wide range of careers, spanning continents and changing lives, in the last 60 years. Amidst this global pandemic, women have access to a limited set of health services and facilities. Many of them are also skipping important medical check-ups due to fear of contracting the virus. The United Nations Populations Fund (UNFPA) reported recently that 47 million women in 114 low- and middle-income countries may not be able to access modern contraceptives and 7 million unintended pregnancies are expected to occur if the lockdown continues for 6 months and there are major disruptions to health services. The pandemic is deepening inequalities, as millions of women and girls risk losing the ability to plan for their families and protect their bodies and their health[1].“Bayer’s commitment to women’s health dates back more than 90 years. As a trusted partner and leader in Women’s Health, Bayer has been supporting women’s health and family planning needs for the past decades and is committed to helping women achieve their aspirations for the next 60 years. We recognize the need to overcome social barriers and discuss topics like contraception and endometriosis which concern women’s health and society at large”, says Manoj Saxena, Managing Director Bayer Zydus Pharma. This year, with the ongoing pandemic, where a typical Indian homemaker caters to both young and old, many women are exposed to greater health risks, often at the expense of their own health. Although, many women play empowered roles in all spheres of life, they often ignore and keep silent about their own health issues. In India, where women’s health remains a primary concern, the means to receive credible and reliable information is often limited. It is therefore time to focus on what women look forward to – for themselves, for their health, for their families and for every woman. Not just today but for the next 60 years and beyond, women should be empowered to fulfill their healthcare needs and make informed decisions about their health. ]]> <![CDATA[Sun Pharma to initiate Nafamostat trial in Covid-19 patients]]> https://biospectrumindia.com/news/95/16569/sun-pharma-to-initiate-nafamostat-trial-in-covid-19-patients.html https://biospectrumindia.com/news/95/16569/sun-pharma-to-initiate-nafamostat-trial-in-covid-19-patients.html Fri, 29 May 2020 13:05:00 +0530 Sun Pharmaceutical Industries Ltd. has announced that it has received approval from the Drugs Controller General of India (DCGI) to initiate a clinical trial with Nafamostat Mesilate in Covid-19 patients. Nafamostat is approved in Japan for improvement of acute symptoms of pancreatitis and treatment of Disseminated Intravascular Coagulation (DIC). A group of scientists from the University of Tokyo, Japan and Leibniz Institute for Primate Research, Germany have recently demonstrated that Nafamostat, at very low concentrations, suppresses a protein (TMPRSS2) that the Covid-19 virus uses to enter human lung cells. Another group from Institut Pasteur, South Korea, also published data comparing antiviral efficacy of 24 drugs and Nafamostat, against SARSCoV-2 in in-vitro studies in human lung epithelial derived cells. In this research, Nafamostat was found to be the most potent drug and was able to inhibit virus entry at very low concentrations, consistent with findings from Japan and German labs. Globally, there are three clinical trials currently underway to test Nafamostat in Covid-19 patients. These trials are being led by the University of Tokyo Hospital, Japan; Gyeongsang National University Hospital (South Korea); and a collaborative trial by University Hospital, Padova, Italy, University of Zurich, Switzerland and Yokohoma City University, Japan (RACONA study). Considering the pandemic situation and urgent need for newer treatment options, Sun Pharma plans to initiate the clinical trials at the earliest. The company has initiated manufacturing of both, the API and the finished product of Nafamostat in India, using technology from its subsidiary, Pola Pharma Japan. ]]> <![CDATA[Healthium MedTech unveils novel anti-microbial gloves]]> https://biospectrumindia.com/news/95/16555/healthium-medtech-unveils-novel-anti-microbial-gloves.html https://biospectrumindia.com/news/95/16555/healthium-medtech-unveils-novel-anti-microbial-gloves.html Fri, 29 May 2020 08:10:00 +0530 Bengaluru based Healthium Medtech, one of the largest medical device companies in India, has announced the launch of the first of its kind Anti-Microbial Gloves, TruShield. Manufactured at Kunigal, Karnataka, these Anti-Microbial Gloves (AMGs) are made from a patented technology using a Quaternary Ammonium Compound that kills microbes and provides 99.99% protection for Healthcare professionals (HCPs) and patients up to 8 hours. The Anti-Microbial gloves are the 3rd Innovative launch for Healthium in the last 6 months. The company had launched Truglyde SN2355, a suture needles combination specially created for COMOC MG, an Innovative surgical technique to manage Postpartum Hemorrhage (PPH), which is one of the largest causes for maternal mortality. Healthium also launched the largest shoulder range of Arthroscopic devices in India benefitting Arthroscopy surgeons through simplified and functional patented designs. The Company holds 52 patents in India and the U.S.    These gloves have not yet been explored for anti-viral purposes but in the current pandemic scenario, the demand is the leading the makers to look into this aspect also. ]]> <![CDATA[IIL launches classical swine fever vaccine in India]]> https://biospectrumindia.com/news/95/16562/iil-launches-classical-swine-fever-vaccine-in-india.html https://biospectrumindia.com/news/95/16562/iil-launches-classical-swine-fever-vaccine-in-india.html Fri, 29 May 2020 07:15:00 +0530 Hyderabad based Indian Immunologicals Limited (IIL), a leading veterinary and human vaccines manufacturing company, today announced the launch of the Classical Swine Fever (CSF) vaccine under the  brand name – ‘Raksha Class’- into the market. This unique cell culture technology-based vaccine has been developed in collaboration with the Indian Veterinary Research Institute (IVRI), Bareilly. The Classical Swine Fever (CSF) is a highly contagious viral disease of pigs caused by an RNA virus. This disease has a high fatality rate and therefore, pig growers face serious economic problems with the loss of the herd. The Raksha Class vaccine is a live attenuated vaccine and has been tested for safety, sterility, and potency. The field trials for the vaccine were conducted at Bengaluru and Hyderabad Veterinary colleges. Raksha Class offers distinct advantages in terms of safety and can be scaled up in cell cultures to meet entire country’s requirements. The current requirement is about 22 million doses and the supply is less than a million doses. The current vaccines manufactured by a few state biologicals depend on the rabbits for vaccine production, where consistency in yields, virus titres, safety and efficacy might not be achieved to the desired levels. IIL’s manufacturing facilities can make several million doses of the vaccine. Speaking on the occasion, Dr K Anand Kumar, Managing Director, Indian Immunologicals Limited said, “The Classical Swine Fever is one of the major diseases of pigs in India. It causes a loss of about Rs. 400 crores per annum in India. The disease has led to a decrease of pig population in the country. With the launch of Raksha Class, we can ensure that the pig population in India can be increased and hence, the growers will be immensely benefited economically”. Elaborating the pig farming in the country, Dr Prasanna Deshpande, Dy. Managing Director, Indian Immunologicals Limited said, “The current pig population in India is estimated to be around 9 million. More than 50% of these piggery units are concentrated in North east region of the country.  Classical Swine Fever is prevalent in almost all the states where this pig population exists. Raksha Class will address the country’s requirements and offer the vaccine at an affordable cost to the growers in India”. Indian Immunologicals Limited was also the first company in the world to launch a vaccine for porcine cysticercosis – Cysvax – which targets a major parasitic disease that causes approximately 40% of epilepsy in humans in the developing world. ]]> <![CDATA[Biocon receives DCGI approval to use CytoSorb for COVID-19 patients]]> https://biospectrumindia.com/news/95/16542/biocon-receives-dcgi-approval-to-use-cytosorb-for-covid-19-patients.html https://biospectrumindia.com/news/95/16542/biocon-receives-dcgi-approval-to-use-cytosorb-for-covid-19-patients.html Thu, 28 May 2020 08:05:00 +0530 Bengaluru based Biocon Ltd., an innovation-led global biopharmaceuticals company, announced that its subsidiary Biocon Biologics has received the Drugs Controller General of India’s (DCGI) approval for an extracorporeal blood purification (EBP) device CytoSorb® to reduce pro-inflammatory cytokines levels in confirmed COVID-19 patients admitted to the intensive care unit (ICU) with confirmed or imminent respiratory failure. Biocon Biologics has been granted licence for emergency use of CytoSorb in public interest by the Indian health regulator to treat COVID-19 patients who are 18 years of age or older. The licence will be effective until control of the COVID-19 outbreak in the country. Studies have shown that COVID-19 patients who develop serious complications experience a ‘cytokine storm,’ also known as Cytokine Release Syndrome (CRS), which leads to excessive inflammation, organ failure and death. The goal of CytoSorb therapy is to reduce cytokine storm and the deadly inflammatory response through blood purification so that this injury may be mitigated or prevented.  The Company has received approval from DCGI in Form MD-15 (Medical Device) for reducing pro-inflammatory cytokine levels in order to control the ‘cytokine storm’ and benefit COVID-19 patients who are in a critical condition. Kiran Mazumdar-Shaw, Executive Chairperson, Biocon, said: “As a science-led organization, Biocon’s endeavour is to provide innovative solutions to patients to address their unmet needs. CytoSorb is an in-licensed unique device that reduces cytokine storm in critically ill patients and was introduced by Biocon in India in 2013. Since then many patients undergoing organ transplant and sepsis treatment have benefitted from it.  DCGI approval for emergency use of CytoSorb for critical COVID-19 patients is an important example of how industry and regulators are working in tandem to urgently provide physicians and patients with new treatment options in the fight against COVID-19. CytoSorb will be an important addition to the Indian medical community’s arsenal against the deadly coronavirus.” With more than 80,000* documented active coronavirus infections and over 4,000* deaths, India needs new therapies to reduce the severity of this disease.  CytoSorb is plug-and-play compatible with the most commonly used blood purification machines or pumps in the ICU used to treat COVID-19 patients, including hemoperfusion, hemodialysis, continuous renal replacement therapy (CRRT), and extracorporeal membrane oxygenation (ECMO) machines. In April, the U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) of CytoSorb for use in patients with COVID-19 infection. ]]> <![CDATA[Richcore produces two key enzymes for COVID-19 RT PCR kits]]> https://biospectrumindia.com/news/95/16544/richcore-produces-two-key-enzymes-for-covid-19-rt-pcr-kits.html https://biospectrumindia.com/news/95/16544/richcore-produces-two-key-enzymes-for-covid-19-rt-pcr-kits.html Thu, 28 May 2020 08:00:00 +0530 National Biomedical Resources Indigenisation Consortium (NBRIC) is delighted to announce that Richcore Life Sciences, a Bengaluru based biotech company, has optimised and produced two key enzymes, needed for RT PCR test kits, which were hitherto proving to be a key bottleneck in India’s efforts to mass produce indigenous test kits. In a true public-private partnership model, Richcore with help of scientists from IISER Chandigarh/Pune and IISC, has optimised and produced two key enzymes, “Taq Polymerase” and “Reverse Transcriptase” needed for RT PCR test kits. These enzymes are currently not produced at scale in India and require cGMP certification: these enzymes form a key bottleneck in India’s efforts to mass produce indigenous test kits. “We are currently providing enzyme samples to test kit manufacturers to confirm the stability and consistency of our enzymes. Once approved, we will be able to mass produce cGMP certified enzymes for millions of test kits in few weeks’ time” said Mr. R. Subramani, Chairman and Managing Director, Richcore. “I am pleased to see Richcore respond so rapidly to develop these key components for rt-PCR tests, which is reflection on their expertise. I am confident that we will have 100% Made in India Covid19 kits in the imminent future.”  Dr. Kiran Mazumdar Shaw, Chair, Governing Council, NBRIC said C-CAMP CEO and Director, Dr. Taslimarif Saiyed, also Convener of the NBRIC Governing Council, said “As India fights the Covid19 pandemic, we need key enzymes and reagents in large-scale to address the urgent need of testing kits across India. This recent development from Richcore further strengthens our efforts and takes us towards more self-reliant ecosystem during these difficult times. NBRIC will work with all stakeholders and bring more development to the fore, with an aim of a joint fight against Covid19 pandemic.” ]]> <![CDATA[Glenmark receives ANDA approval for Chlorzoxazone Tablets ]]> https://biospectrumindia.com/news/95/16539/glenmark-receives-anda-approval-for-chlorzoxazone-tablets-.html https://biospectrumindia.com/news/95/16539/glenmark-receives-anda-approval-for-chlorzoxazone-tablets-.html Wed, 27 May 2020 10:50:00 +0530 Glenmark Pharmaceuticals has been granted final approval by the United States Food & Drug Administration (USFDA) for Chlorzoxazone Tablets USP, 375 mg and 750 mg. This marks Glenmark’s first ANDA approval out of their new North American manufacturing facility based in Monroe, North Carolina. According to IQVIATM, sales data for the 12-month period ending March 2020, the Chlorzoxazone Tablets, 375 mg and 750 mg market2 achieved annual sales of approximately $20.9 million. Glenmark’s current portfolio consists of 163 products authorized for distribution in the U.S. marketplace and 45 ANDA’s pending approval with the USFDA. In addition to these internal filings, Glenmark continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio. ]]> <![CDATA[Hamdard Labs offers immunity booster medicine to fight COVID-19]]> https://biospectrumindia.com/news/95/16538/hamdard-labs-offers-immunity-booster-medicine-to-fight-covid-19.html https://biospectrumindia.com/news/95/16538/hamdard-labs-offers-immunity-booster-medicine-to-fight-covid-19.html Wed, 27 May 2020 10:00:00 +0530 Hamdard Laboratories (Medicine Division), a progressive, research based health and wellness organization plans to conduct clinical trial of its immunity booster medicines to assess its effectiveness against COVID-19. The company has submitted proposal for required permission from the concerned authorities and the clinical trial will be conducted at Hamdard Institute of Medical Sciences and Research in New Delhi. The Ministry of AYUSH has invited inputs from AYUSH practitioners and institutions including colleges/ universities, hospitals, research institutes, AYUSH manufacturers, AYUSH association’s etc. to prevent infection from Covid-19. Hamdard Laboratories is working in the same direction and has submitted its inputs to the AYUSH department.  AYUSH ministry’s task force is examining the proposals submitted by AYUSH Institutions. Then, it will be send to Indian Council of Medical Research (ICMR) which will register such clinical proposals and evaluate the outcome of studies for clinical efficacy of such products. Hamdard Laboratories (Medicine Division) has a wide range of immunity boosting Unani medicines in its portfolio. Hamdard’s immunity booster products such as Joshina, Joshanda, Kulzum, Infuza and Imyoton enhance the body’s immune system. These are effective herbal remedies for flu, cough and cold particularly in chronic cases. Mr. Abdul Majeed, Chairman, Hamdard Laboratories (Medicine Division) said, “Covid-19 is a deadly disease which has severely impacted the whole world. Scientists and pharmaceutical companies across the world are working tirelessly to come up with a vaccine that is effective against the virus. Currently, preventive measures are the only way to fight the Coronavirus and having a strong immunity system is one of the ways to minimize the impact of the virus on the body. We, at Hamdard Laboratories, are foreseeing that clinical trials of immunity boosting Unani medicines will further scientifically establish clinical evidence. Our products are developed with natural formulae that combine the benefits of time tested herbs for strengthening of innate immunity which may be helpful in minimizing the impact of COVID-19 virus through development of specific antibodies. Effective adjunct therapy will push up innate immune capability and facilitate development of specific antibodies to fight against Coronavirus infections. We are hopeful that the trials will yield positive results and will help us fighting the Covid-19 pandemic.” Elaborating on Hamdard’s clinical trial on immunity booster medicines, Dr. Santosh Joshi, Head, Research & Development, Hamdard Laboratories (Medicine Division) said, ‘We truly appreciate the initiatives of ministry of AYUSH for clinical trials and its emphasis on finding a preventive support in AYUSH systems ’. Hamdard has submitted proposal on two products from its portfolio which are proven to be effective immunity boosters as they are having ingredients with potential to adjuvate the immunity against Covid-19 infection. Our team is working tirelessly to test multiple formulations and combinations to study their effectiveness and impact on preventing the infection.” The clinical trials will be carried out on asymptomatic and suspected subjects (due to their exposure with infected patients/in quarantine) to test the efficacy of immunity boosters for preventing and curing the patients. Antibody profiling of the subjects has already been initiated at Hamdard Institute of Medical Sciences and Research (HIMSR) with ICMR approved kits. RT-PCR testing facility is starting very soon after NABL accreditation. The trials result will take couple of months and till then we need to practice social distancing, wear masks, follow good diet, and stay indoors as much as possible to limit the spread of the virus.” ]]> <![CDATA[Glenmark to test Favipiravir, Umifenovir for COVID-19 treatment]]> https://biospectrumindia.com/news/95/16532/glenmark-to-test-favipiravir-umifenovir-for-covid-19-treatment.html https://biospectrumindia.com/news/95/16532/glenmark-to-test-favipiravir-umifenovir-for-covid-19-treatment.html Tue, 26 May 2020 10:10:00 +0530 Glenmark Pharmaceuticals, a research-led, integrated global pharmaceutical company, has announced a new randomized, open-label study to test the combined efficacy of two antiviral drugs Favipiravir and Umifenovir as a potential COVID-19 treatment strategy. The two antiviral drugs have different mechanism of action, and their combination may demonstrate improved treatment efficacy by effectively tackling high viral loads in patients during early stage of disease. Early administration of a combination of antiviral medications acting by different mechanisms is desirable for the treatment of COVID-19, since the viral load of SARS-CoV-2 peaks around the time of symptom onset. Thus combining antiviral drugs could result in greater clinical effectiveness and could also prevent, or delay, the emergence of resistance. Favipiravir is an oral antiviral drug approved in Japan since 2014 for the treatment of novel or re-emerging influenza virus infections. It has a unique mechanism of action by which it inhibits viral replication: it is converted into an active phosphoribosylated form (favipiravir-RTP) in cells and recognized as a substrate by viral RNA polymerase, thereby inhibiting RNA polymerase activity that is required for viral replication. Umifenovir is another oral antiviral drug licensed for the treatment and prophylaxis of influenza A and B infections in Russia and China.5 Umifenovir impedes the viral attachment to cells and acts as a viral entry inhibitor. Additionally it exhibits modulatory effects on the immune system and induces interferon-production. Hence a combined use of Favipiravir and Umifenovir acting on different mechanisms offers a comprehensive antiviral cover on preentry and post-entry life-cycle of the SARS-CoV-2 virus. Both Favipiravir and Umifenovir inhibited virus infection in vitro and have shown efficacy in COVID-19 clinical trials. The current Glenmark study will examine whether early administration of a combination of Favipiravir and Umifenovir, both acting by different mechanisms, enhances antiviral efficacy on COVID-19 patients. The new combination clinical trial will be called FAITH – (FA vipiravir plus Um I fenovir (efficacy & safety) T rial in Indian H ospital setting). Duration of treatment will be 14 days and patients will be discharged after clinical cure and two consecutive negative tests for COVID-19 based on RT-PCR. ]]> <![CDATA[Natco supports Columbia Uni's trial of CQ against COVID-19]]> https://biospectrumindia.com/news/95/16525/natco-supports-columbia-unis-trial-of-cq-against-covid-19.html https://biospectrumindia.com/news/95/16525/natco-supports-columbia-unis-trial-of-cq-against-covid-19.html Mon, 25 May 2020 07:15:00 +0530 Hyderabad based Natco Pharma Limited reiterates its commitment in supporting a clinical trial to prevent symptomatic SARS-CoV-2 infections by donating Chloroquine Phosphate (CQ) Tablets through its marketing partner in the United States, Rising Pharmaceuticals, to a study conducted by Columbia University, New York. After NATCO’s recent donation to a global clinical trial conducted by the CROWN (COVID-19 Research Outcomes Worldwide Network) Collaborative at the Washington University School of Medicine in St. Louis it has now committed to support the Phase 2 of a clinical trial at Columbia University. The trial aims to determine the effectiveness of CQ in preventing COVID-19 infection in healthcare workers with moderate to high risk of exposure to the virus. Researchers at Columbia University are conducting this critical study to assess CQ as prophylaxis against COVID-19 in healthcare workers. The Phase 2 trial will enroll 350 volunteers who work in direct patient care roles at Columbia University Irving Medical Center and who have contact with patients who may have COVID-19 infection. NATCO has been supplying CQ Tablets, a USFDA approved drug, through its marketing partner to the United States since 2011. Columbia University, a private Ivy League research university in New York City established in 1754 is renowned across the world for its expertise in conducting well designed clinical trials and NATCO is glad to work with them on this path breaking trial. ]]> <![CDATA[Cipla receives final approval for generic version of Migranal]]> https://biospectrumindia.com/news/95/16520/cipla-receives-final-approval-for-generic-version-of-migranal.html https://biospectrumindia.com/news/95/16520/cipla-receives-final-approval-for-generic-version-of-migranal.html Fri, 22 May 2020 14:10:00 +0530 Cipla has announced that it has received final approval for its Abbreviated New Drug Application (“ANDA”) for Dihydroergotamine Mesylate Nasal Spray 4mg/mL from the United States Food and Drug Administration (U.S. FDA) with a Competitive Generic Therapy (“CGT”) designation. Cipla is the “first approved applicant” for such CGT and, is therefore, eligible for 180 days of CGT exclusivity which will begin to run from the commercial marketing of Cipla’s product. This 180-day CGT exclusivity will not block the commercialization of the existing approvals of Dihydroergotamine Mesylate Nasal Spray, 4 mg/mL. Cipla’s Dihydroergotamine Mesylate Nasal Spray 4mg/mL is AB-rated generic therapeutic equivalent version of Bausch Health US LLC’s Migranal®. This is Cipla’s first ANDA approval for a nasal spray. It is indicated for the acute treatment of migraine headaches with or without aura. According to IQVIA (IMS Health), Migranal® and its authorized generic equivalents had U.S. sales of approximately $102M for the 12-month period ending March 2020.   ]]> <![CDATA[Lupin receives approval for Trientine Hydrochloride Capsules]]> https://biospectrumindia.com/news/95/16519/lupin-receives-approval-for-trientine-hydrochloride-capsules.html https://biospectrumindia.com/news/95/16519/lupin-receives-approval-for-trientine-hydrochloride-capsules.html Fri, 22 May 2020 14:05:00 +0530 Lupin has announced that it has received approval for its Trientine Hydrochloride Capsules USP, 250 mg, from the United States Food and Drug Administration (USFDA), to market a generic equivalent of Syprine® Capsules, 250 mg, of Bausch Health US, LLC. The product would be manufactured at Lupin’s Nagpur (Unit 1) facility, India. Trientine Hydrochloride Capsules USP, 250 mg, are indicated in the treatment of patients with Wilson's disease who are intolerant of penicillamine. Trientine Hydrochloride Capsules USP (RLD: Syprine®) had an annual sales of approximately USD 86 million in the U.S. (IQVIA MAT March 2020). ]]> <![CDATA[Boehringer Ingelheim receives DCGI approval for SSc-ILD drug]]> https://biospectrumindia.com/news/95/16505/boehringer-ingelheim-receives-dcgi-approval-for-ssc-ild-drug.html https://biospectrumindia.com/news/95/16505/boehringer-ingelheim-receives-dcgi-approval-for-ssc-ild-drug.html Fri, 22 May 2020 07:15:00 +0530 Boehringer Ingelheim (India) announced that the DCGI has approved Nintedanib for the treatment of systemic sclerosis-associated interstitial lung disease (SSc-ILD) in adults. The approval comes after the Subject Expert Committee (CDSCO) had adopted a positive opinion for Nintedanib in treatment of SSc-ILD on 3rd March 2020. Systemic sclerosis (SSc), also known as scleroderma, is a disfiguring, disabling and potentially fatal rare autoimmune disease. It causes scarring (fibrosis) of various organs, including the lungs, heart, digestive tract and kidneys and can lead to life-threatening complications. When the lungs are affected, it can cause interstitial lung disease (ILD), known as SSc-ILD. ILD is a leading cause of mortality, accounting for almost 35% of SSc-related deaths. “Systemic sclerosis is a life- altering condition and Nintedanib is the first and only approved treatment for SSc-ILD, serving a high unmet need making a real positive difference. For the treatment of people living with SSc-ILD, this is a quantum leap” said Sharad Tyagi, MD, Boehringer Ingelheim India. “The DCGI approval is a milestone in Boehringer Ingelheim’s dedication towards providing the best possible treatment for people living with SSc-ILD in India.” he added. DCGI’s approval is based on the results of the SENSCIS® trial, a Phase III, double-blind, placebo-controlled trial conducted to investigate the efficacy and safety of Nintedanib in patients with SSc-ILD. The primary endpoint was the annual rate of decline in Forced Vital Capacity (FVC) assessed over a 52-week period. Results showed Nintedanib slowed the loss of pulmonary function by 44% (41mL/year) relative to placebo, as measured in FVC over 52 weeks.1 Furthermore, results showed that Nintedanib had a safety and tolerability profile similar to that observed in patients with idiopathic pulmonary fibrosis (IPF). Regulatory approvals for the treatment of patients living with SSc-ILD have also been granted in several countries including EU, Canada, Japan and Brazil. Nintedanib is approved in over 75 countries for the treatment of IPF, and it is the first approved treatment for SSc-ILD. ]]> <![CDATA[Sami-Sabinsa reveals benefits of its cosmeceutical ingredient]]> https://biospectrumindia.com/news/95/16506/sami-sabinsa-reveals-benefits-of-its-cosmeceutical-ingredient.html https://biospectrumindia.com/news/95/16506/sami-sabinsa-reveals-benefits-of-its-cosmeceutical-ingredient.html Thu, 21 May 2020 12:00:00 +0530 Two new studies have recently been published on the topical benefits of Sami-Sabinsa’s pTeroWhite® natural pterostilbene isolated and purified from Pterocarpus marsupium heartwood and formulated as a cream. The studies further the body of science into pTeroWhite’s value as a cosmeceutical ingredient for anti-aging, skin brightening, and as a natural SPF agent. An Open-Label Single-Arm, Monocentric Study Assessing the Efficacy and Safety of Natural Pterostilbene (Pterocarpus Marsupium) for Skin Brightening and Antiaging Effects , published in Clinical, Cosmetic and Investigational Dermatology, was conducted as an open-label, singlearm, monocentric efficacy investigation in 38 healthy volunteers who applied a cream containing 0.4% pterostilbene for eight weeks. The researchers observed a positive change at all time points in skin hydration and elasticity in both male and female subjects with regular usage of the pTeroWhite cream. They found significant improvement in under-eye fine lines at all-time points and in wrinkles, frown lines, and crow’s feet area at the end of the study. The pterostilbene preparation was able to improve the skin luminosity with continuous application. A second clinical study, A Randomized Study to Determine the Sun Protection Factor of Natural Pterostilbene from Pterocarpus Marsupium , published in the journal Cosmetics, demonstrated the effect of pTeroWhite as a natural SPF ingredient. The study concluded that pTeroWhite could be a safe ingredient in topical sun-protective formulations.  “We’ve long thought that natural pterostilbene had tremendous potential in cosmeceutical applications, which is why we began conducting research,” said Sami-Sabinsa Group’s Founder and Chairman Dr. Muhammed Majeed. “Investigations are continuing to further expand our knowledge to support new product applications.” ]]> <![CDATA[SCTIMST, Agappe unveil RNA extraction kit for COVID-19 detection]]> https://biospectrumindia.com/news/95/16503/sctimst-agappe-unveil-rna-extraction-kit-for-covid-19-detection.html https://biospectrumindia.com/news/95/16503/sctimst-agappe-unveil-rna-extraction-kit-for-covid-19-detection.html Thu, 21 May 2020 08:00:00 +0530 Agappe Chitra Magna, a magnetic nanoparticle-based RNA extraction kit has been launched for use during testing for detection of COVID-19. It is developed by Sree Chitra Tirunal Institute for Medical Sciences and Technology (SCTIMST) - Trivandrum, an Institute of National Importance of the Department of Science and Technology (DST) along with Agappe Diagnostics Ltd, an in vitro diagnostics manufacturing company based in Cochin. Inexpensive, fast, and accurate testing for COVID-19 virus is the cornerstone of containing its spread and providing appropriate help to the infected. The Chitra Magna, an innovative RNA extraction kit developed by SCTIMST under the leadership of senior scientist, Dr. Anoopkumar Thekkuveettil, was transferred to Agappe Diagnostics in April 2020, and will now be available in the market as Agappe Chitra Magna RNA Isolation Kit. This product has been independently validated at National Institute of Virology for Covid19 RNA isolation. Central Drugs Standard Control Organisation (CDSCO) has given approval for the commercialization of this kit. The kit can be used for RNA extraction for RT-LAMP, RT-qPCR, RT-PCR and other isothermal and PCR based protocols for the detection of SARS-COV-2. It uses an innovative technology for isolating RNA using magnetic nanoparticles to capture the RNA from the patient sample. The magnetic nanoparticle beads bind to the viral RNA and, when exposed to a magnetic field, give a highly purified and concentrated RNA. As the sensitivity of the detection method is dependent on getting an adequate quantity of viral RNA, this innovation enhances the chances of identifying positive cases. It is estimated that India would require about 8 lakh RNA extraction kits per month during the next six months, and Agappe Chitra Magna RNA Isolation Kit priced around Rs. 150 per kit is expected to reduce the cost of testing and the country’s dependence on imported kits which cost around Rs 300. Agappe Diagnostics has a manufacturing capacity of 3 lakh kits per month. ]]> <![CDATA[Lincoln Pharma receives EU GMP approval]]> https://biospectrumindia.com/news/95/16508/lincoln-pharma-receives-eu-gmp-approval.html https://biospectrumindia.com/news/95/16508/lincoln-pharma-receives-eu-gmp-approval.html Thu, 21 May 2020 00:00:00 +0530 Ahmedabad based Lincoln Pharmaceuticals Limited, one of India's leading healthcare companies has received the European Union (EU) GMP certification from Germany FDA for its manufacturing facility located at Khatraj in Gujarat. The certification will allow the company to market its products in all the 27 member countries of EU and also give access to the European Economic Area (EEA) countries. Company looks to enter the EU markets very soon with its dermatology, gastro and pain management products and gradually expand product portfolio. The inspection was done by the regulatory agency in December 2019 followed by final approval in May 2020. The company manufactures wide-range of drugs at its Khatraj facility and includes anti-infective, respiratory system, gynaecology, dermatology, gastro, pain management, cardio & CNS, anti-bacterial, anti-diabetic, anti-malaria among others. Mahendra Patel, Managing Director, Lincoln Pharmaceuticals Limited, said, "We are very pleased and excited to receive the EU GMP accreditation. This will be an important stepping stone in the journey of the company and will help to expand its presence in more regulated markets. The approval is valid for all three departments Tablet, Capsule and Cream & Ointment, which will cover wide range of Pharmaceutical Formulation manufactured by the Company. EU GMP approval is the result of stringent quality and compliance norms followed at Lincoln Pharma across all departments especially the R&D and compliance. The certification will allow us to address the growing needs of patients in the EU markets and provide affordable and innovative medicines." With the EU certification, company will expand its business network to 90 plus countries. Company currently exports to 60 plus countries including East & West Africa, Central & Latin America and Southeast Asia and has got many product registrations in these countries and is also awarded with number of global tenders. Export business has shown remarkable growth in the last few years. Exports have increased to 61% of total sales in FY20 from 11% of total sales in FY11. Company has almost doubled the export turnover in FY20 as compared to FY18. Export of the company stood at Rs. 227 crore in FY 20 as compared to Rs. 197 crore in FY 19, a growth of 15% Y-O-Y. "Over the years, company has seen good traction in the export business, which is expected to get further boost once EU operations begins. For the next phase of growth, company is building a strong portfolio in lifestyle and chronic segment especially dermatology, gastro and pain management to complement its strong presence in acute segment. Strategic growth initiatives, EU approval, new product approvals, better margin products along with operational efficiency are likely to contribute healthy growth and maximise value for all stakeholders in the near to medium term," said Mr. Patel. ]]> <![CDATA[Eris Lifesciences launches TruSaniz hand sanitizer]]> https://biospectrumindia.com/news/95/16511/eris-lifesciences-launches-trusaniz-hand-sanitizer.html https://biospectrumindia.com/news/95/16511/eris-lifesciences-launches-trusaniz-hand-sanitizer.html Thu, 21 May 2020 00:00:00 +0530 Eris Lifesciences under its fully owned subsidiary Eris Healthcare Pvt Ltd, has launched a hand sanitizer brand - TruSaniz. Through many years, Eris Lifesciences has maintained its focus in the disease management space by targeting therapies such as diabetology, cardiology, gastroenterology, neurology, etc. Now, with the launch of TruSaniz and other OTC products, the aim is to focus on disease prevention. The newly launched hand sanitizer is a part of the OTC product portfolio, which was envisaged earlier this year. With the rising number of COVID-19 cases, there is a greater need for maintaining personal hygiene and sanitation along with building immunity; even more for the people with comorbidities with reports that indicate higher mortality rates amongst these patients. Complying with the highest standards of quality and following all government regulations, the hand sanitizer will be made available across all chemist stores in India. Launched in two variants, liquid and spray, it is packaged in 100ml (Rs. 50), 250 ml (Rs 125) and 500ml (Rs 249) for the liquid variant, whereas the spray is available for Rs 179 for a bottle of 170gm. Commenting on the development, Amit Bakshi, Chairman and Managing Director, Eris Lifesciences said, “We have always worked towards managing disease burden for our patients. While control and management form an important aspect in building a strong healthcare system, disease prevention is equally important to strengthen pro-activity, and thus our range of products in this category will be helpful in combating diseases better. It will also help us expand our representation in the acute market.”     ]]> <![CDATA[Bharat Biotech pursuing new COVID-19 vaccine candidate]]> https://biospectrumindia.com/news/95/16499/bharat-biotech-pursuing-new-covid-19-vaccine-candidate.html https://biospectrumindia.com/news/95/16499/bharat-biotech-pursuing-new-covid-19-vaccine-candidate.html Wed, 20 May 2020 17:00:00 +0530 Global Leader and vaccine innovator Bharat Biotech and Thomas Jefferson University of Philadelphia have signed an exclusive deal to develop a new vaccine candidate for COVID-19 invented at Jefferson. The novel vaccine was developed using an existing deactivated rabies vaccine as a vehicle for coronavirus proteins. This is in part because this vehicle or carrier vaccine is known to produce a strong immune response, and is approved for the whole population including children and pregnant women. Infectious Diseases expert Professor Matthias Schnell’s lab developed the vaccine in January this year, and has recently completed preliminary tests in animal models. The vaccine showed a strong antibody response in mice receiving the vaccine.  The researchers are currently testing whether vaccinated animals are protected from SARS-CoV-2 infection with results expected in the next month. “Our partnership with Bharat Biotech will accelerate our vaccine candidate through the next phases of development,” says Prof. Schnell - a coronavirus expert who directs The Jefferson Vaccine Institute and chairs Jefferson’s Department of Microbiology and Immunology, “We will be able to complete animal testing and move to phase 1 clinical trial rapidly” he adds. Dr. Krishna Mohan, Chief Executive Officer of Bharat Biotech said, “In view of the imminent demand for an effective vaccine, Bharat Biotech is pleased to collaborate with Thomas Jefferson, USA towards developing a new vaccine for COVID-19 using an inactivated rabies vector platform. We are particularly excited about this technology since the basic proof of concept has been established while using it for other pandemic infectious diseases. Bharat Biotech is committed to global public health and will be involved in an end to end development of the vaccine including comprehensive clinical trials to achieve commercial licensure.” Under the license agreement, Bharat Biotech gains exclusive rights to develop, market and deliver Jefferson’s vaccine across the world excluding countries such as USA, Europe, Japan etc., where Jefferson continues to seek partners. With support from the Department of Biotechnology, Govt. of India, Bharat Biotech aims to get into human trials as soon as December 2020. “Bharat Biotech is the world’s largest supplier of rabies vaccines, and has been at the forefront of creating breakthrough vaccines for several challenging diseases”, said Dr. Rose Ritts, Jefferson’s Innovation EVP, who led the negotiations with the assistance of Dr. Heather Rose, Innovation VP. “They are the right partner for Jefferson to accelerate this important project with urgency.”  Of the 90 or so coronavirus vaccines in development, about 25% use an established vaccine to act as a “carrier” or vector for the target virus, in this case, the coronavirus SARS-COV-2 spike protein. The vector used in this new vaccine is a deactivated rabies vaccine that is known to produce a strong immune response, and that has been proven safe for all populations including children and pregnant women. Not every vaccine produces the same level of the immune response. The rabies vaccine has been shown to generate a rigorous but safe immune reaction that confers life-long protection. “Since we know the immune system reacts to the rabies vaccine with a strong response when we add the coronavirus component, we expect to see that level of protection, and immune memory, carry over to the SARS-CoV-2 viral protein as well,” says Prof. Schnell. Prof. Schnell’s prior research creating vaccines with this approach against two other strains of coronavirus (the 2003 SARS and 2012 MERS viruses), worked in this way, conferring strong immunity in animal models.  “We are leveraging the properties of a very effective vaccine – one that provides life-long immunity against one of the biggest global threats of our time,” says Dr. Mark Tykocinski MD, Provost and Executive Vice President for Academic Affairs of Thomas Jefferson University, and Dean of its Sidney Kimmel Medical College. “Rather than go with an untested approach, we have a leg-up by using a vaccine that is safe, effective, and exceptionally good at creating a strong immune response – which is something not every vaccine can do.” ]]> <![CDATA[Excelra inks agreement with Lawrence Livermore National Laboratory]]> https://biospectrumindia.com/news/95/16493/excelra-inks-agreement-with-lawrence-livermore-national-laboratory.html https://biospectrumindia.com/news/95/16493/excelra-inks-agreement-with-lawrence-livermore-national-laboratory.html Wed, 20 May 2020 05:05:00 +0530 Under a three-year agreement, Hyderabad based Excelra – a leading global data and analytics company – will provide US based Lawrence Livermore National Laboratory (LLNL) with GOSTAR, a small molecule medical chemistry intelligence database to aid drug design projects. The platform will support the aims of the Accelerating Therapeutics for Opportunities in Medicine (ATOM) consortium, which seeks to reduce the drug discovery process from six years down to one year. Excelra will give LLNL (a member of the ATOM consortium) full access to GOSTAR – a vast repository of approximately 8 million small molecule discovery compounds and ~40,000 preclinical/clinical candidates and approved drugs. In addition to periodic data updates, Excelra will also provide custom curation support and data preparation for AI/ML modelling on a need basis. GOSTAR is the world's largest small molecule medicinal chemistry intelligence platform that provides a comprehensive overview of millions of compounds, linking chemical structure to biological, pharmacological and therapeutic activities. It aids in early and optimization stages of drug discovery. The Accelerating Therapeutics for Opportunities in Medicine (ATOM) consortium is a public-private partnership with the mission of transforming drug discovery by accelerating the development of more effective therapies for patients.  Jonathan Allen, LLNL Bioinformatics Scientist and ATOM R&D Team Lead said: "Experimental data curated to support computational modeling work is a critical element of ATOM's pre-clinical discovery pipeline. We look forward to working with GOSTAR and leveraging Excelra's expertise to improve data-driven, small molecule property prediction."  Raveendra Dayam, Director Chemistry Services, Excelra said: "GOSTAR allows discovery researchers navigate through known and quantified interactions of small molecules with drug targets representing the vast biological space. We are glad to partner with LLNL to support their drug design platform aimed at shortening drug discovery timelines." ]]> <![CDATA[Lupin launches generic version of Apriso]]> https://biospectrumindia.com/news/95/16488/lupin-launches-generic-version-of-apriso.html https://biospectrumindia.com/news/95/16488/lupin-launches-generic-version-of-apriso.html Tue, 19 May 2020 13:45:00 +0530 Lupin has announced the launch of authorized generic version of Bausch Health’s Apriso® (Mesalamine Extended-Release Capsules 0.375 g) in the U.S. Mesalamine Extended-Release Capsules 0.375 g (authorized generic version) are indicated for the maintenance of remission of ulcerative colitis in patients 18 years of age and older. Mesalamine Extended-Release Capsules 0.375 g, RLD: Apriso® had an annual sales of approximately USD 290 million in the U.S. (IQVIA MAT March 2020).   ]]> <![CDATA[Premas Biotech, Akers Bio announce successful completion of COVID-19 vaccine prototype]]> https://biospectrumindia.com/news/95/16477/premas-biotech-akers-bio-announce-successful-completion-of-covid-19-vaccine-prototype.html https://biospectrumindia.com/news/95/16477/premas-biotech-akers-bio-announce-successful-completion-of-covid-19-vaccine-prototype.html Mon, 18 May 2020 08:05:00 +0530 US based Akers Biosciences, Inc., a developer of rapid health information technologies, has announced that Gurugram based Premas Biotech, its partner in the development of a vaccine candidate that is seeking to address the COVID-19 pandemic, has successfully completed its vaccine prototype. Premas obtained transmission electron microscopic (TEM) images of the recombinant virus like particle (VLP) assembled in yeast during the past week which marks a significant milestone and is believed by Premas to be one of the first in the world for VLP of SARS-CoV-2 virus. Premas, which is primarily responsible for the development of the vaccine candidate through proof of concept, is collating data at this time and, collectively with Akers, moving forward with conversations with regulatory authorities in India and continuing to develop a regulatory strategy in the United States. A manufacturing protocol has also been established and large-scale production studies have been initiated for the vaccine candidate. Prabuddha Kundu, Co-Founder and Managing Director at Premas Biotech, commented, “We are delighted to announce the three protein VLP formation as confirmed from the TEM images and other orthogonal analysis that have captured the distinct structural features of the VLP. The vaccine candidate is based on the three COVID-19 proteins; Spike, Envelope and Membrane. We believe that this combination of three proteins distinguishes us from other companies seeking to develop COVID-19 vaccines and makes the VLP promising as we work to proceed into pre-clinical trials.” Christopher Schreiber, Executive Chairman of Akers, stated, “We are encouraged by the recent progress made with Premas. As our next step, we will present our findings to regulatory authorities with the intent of initiating pre-clinical trials this summer. We will keep shareholders informed as we proceed through our milestones.” ]]> <![CDATA[Hikal announces the successful development of Favipiravir API]]> https://biospectrumindia.com/news/95/16461/hikal-announces-the-successful-development-of-favipiravir-api.html https://biospectrumindia.com/news/95/16461/hikal-announces-the-successful-development-of-favipiravir-api.html Fri, 15 May 2020 12:10:00 +0530 Hikal Limited, a leading manufacturer and supplier of API's and intermediates globally has announced the successful development of Favipiravir Active Pharmaceutical ingredient (API) and its intermediates. Favipiravir is a generic version of Avigan of Fujifilm Toyama Chemical Co. Ltd., Japan, a subsidiary of Fujifilm Corporation. Favipiravir has demonstrated activity against influenza viruses and has been approved in Japan for the treatment of novel influenza virus infections. It is in various stages of clinical trials in many countries as an experimental treatment of COVID-19. The company is in discussion with potential partners to supply the API and its intermediates. Hikal has developed this API in a record amount of time to make the product available for treatment of COVID-19. This demonstrates Hikal's commitment to support in the fight against COVID-19 virus and to provide high quality medicines to its customers globally.   ]]> <![CDATA[Cipla supports Siliguri in the fight against COVID-19 ]]> https://biospectrumindia.com/news/95/16452/cipla-supports-siliguri-in-the-fight-against-covid-19-.html https://biospectrumindia.com/news/95/16452/cipla-supports-siliguri-in-the-fight-against-covid-19-.html Thu, 14 May 2020 16:25:00 +0530 Cipla has announced a number of initiatives that it has undertaken to tackle the COVID-19 pandemic in Siliguri. The Company recently launched an INR 25 crore ‘Caring for Life’ COVID-19 dedicated Fund to further several immediate and long-term relief efforts that the country needs to combat the crisis. Through its wide-ranging relief measures pan India, the Company is focusing on initiatives that have the maximum impact and reach. In Siliguri, its efforts are primarily targeted at the safety and wellbeing of its employees as well as the lesser-privileged members of the community who have low access to basic necessities. Through a specially constituted central COVID-19 taskforce, Cipla Siliguri has designed an effective mechanism comprising various aspects to safeguard its employees. The Company is undertaking frequent sanitisation of the facility premises, employee transport vehicles and Goods carriers. All employees are provided with sanitizers, masks, hand gloves and safety goggles to ensure personal protection. The Company is ensuring business continuity so that manufacturing and distribution of essential medicines can continue for patients in these difficult times. Cipla has also launched a toll-free helpline to assist its patients in procuring essential medication across therapies from pharmacies and health-care institutions. In furtherance of its responsibility to the community, the Company has collaborated with ActionAid India to ensure the wellbeing of 100 families in need, who reside in the vicinity of the Cipla depot. As part of this, a total of 108 ration kits have been distributed. In addition, the Company has been supporting long distance truckers engaged in the transportation of goods to and fro for Cipla with ration kit   ]]> <![CDATA[Hetero partners with Gilead Sciences for manufacturing and distribution of Remdesivir ]]> https://biospectrumindia.com/news/95/16451/hetero-partners-with-gilead-sciences-for-manufacturing-and-distribution-of-remdesivir-.html https://biospectrumindia.com/news/95/16451/hetero-partners-with-gilead-sciences-for-manufacturing-and-distribution-of-remdesivir-.html Thu, 14 May 2020 16:15:00 +0530 Hetero, one of India's leading generic pharmaceutical companies and the world's largest producer of anti-retroviral drugs, announced that it has entered into a licensing agreement with Gilead Sciences, Inc. for the manufacturing and distribution of "Remdesivir" for the treatment of Covid-19. Under this licensing deal, Hetero will be supplying Remdesivir in 127 countries, including India, subject to regulatory approvals in respective countries.  Dr. B. Partha Saradhi Reddy, Chairman, Hetero Group of Companies commented, "Hetero is pleased to partner with Gilead to enable access for this important drug to India and other developing countries at this crucial time. This agreement also illustrates the significance of global collaboration and the need for coming together to fight the health crises impacting humanity. Hetero has developed this product in India and has already been working with the government, ICMR, and DCGI for necessary studies and approvals to bring this product to treat COVID-19 patients in India."  “Remdesivir will be manufactured in our formulation facility in Hyderabad, India, which has been approved by stringent global regulatory authorities such as USFDA and EU, among others. Hetero has developed the fully vertically integrated supply chain for this product complementing the "Make in India" campaign as defined by our Hon'ble Prime Minister”, he added. U.S. Food and Drug Administration (FDA) has granted emergency use authorization (EUA) for the investigational antiviral Remdesivir to treat COVID-19 ]]> <![CDATA[Cipla ties up with Gilead for manufacturing Remdesivir]]> https://biospectrumindia.com/news/95/16439/cipla-ties-up-with-gilead-for-manufacturing-remdesivir.html https://biospectrumindia.com/news/95/16439/cipla-ties-up-with-gilead-for-manufacturing-remdesivir.html Thu, 14 May 2020 04:00:00 +0530 Cipla has announced that it has signed a non-exclusive licensing agreement with Gilead Sciences, Inc. for the manufacturing and distribution of the investigational medicine Remdesivir, which has been issued an Emergency Use Authorization (EUA) by the U.S. Food and Drug Administration (FDA) to treat COVID-19 patients. This agreement is part of Cipla’s efforts to enhance global access to life-saving treatments for patients affected by the pandemic. As part of the agreement, Cipla will be permitted to manufacture the API and Finished product, and market it in 127 countries including India and South Africa under Cipla’s own brand name. Cipla will receive the manufacturing know-how from Gilead Sciences, Inc. to manufacture the API and Finished product at a commercial scale. Cipla’s extensive geographical and commercial footprint will help make this therapy accessible to more patients and markets.  According to the World Health Organisation (WHO)’s tracker, the number of reported COVID-19 cases has crossed the four million mark globally. The EUA will facilitate broader use of Remdesivir to treat hospitalized patients with severe symptoms of COVID-19. The EUA is based on available data from two global clinical trials-US National Institute for Allergy and Infectious Diseases’ placebo-controlled Phase 3 study in patients with moderate to severe symptoms of COVID-19, and Gilead’s global Phase 3 study evaluating Remdesivir in patients with severe disease. Multiple additional clinical trials are ongoing to generate more data on the safety and efficacy of Remdesivir as a potential treatment for COVID-19. Remdesivir continues to be an investigational drug that has not been approved by the FDA. Commenting on the partnership, Umang Vohra, MD and Global CEO, Cipla Limited said, “As the world is faced with the COVID-19 crisis, it is imperative that we collaborate and fight this virus together. We are pleased to partner with Gilead for this cause and take this treatment to patients across countries after the required regulatory approvals. At Cipla, it is our continuous endeavour to ensure that no patient is denied access to life-saving treatments. Our partnership with Gilead represents this unwavering commitment and is a significant step towards saving millions of lives impacted by the pandemic.” ]]> <![CDATA[Glenmark initiates Ph 3 trials on Favipiravir for COVID-19 in India]]> https://biospectrumindia.com/news/95/16438/glenmark-initiates-ph-3-trials-on-favipiravir-for-covid-19-in-india.html https://biospectrumindia.com/news/95/16438/glenmark-initiates-ph-3-trials-on-favipiravir-for-covid-19-in-india.html Wed, 13 May 2020 13:00:00 +0530 Glenmark Pharmaceuticals, a research-led integrated global pharmaceutical company, has initiated Phase 3 clinical trials in India on Antiviral tablet Favipiravir, for which it received approval from India's drug regulator DCGI in late April. Glenmark is the first company in India to initiate Phase 3 clinical trials on Favipiravir for COVID-19 patients in India. Favipiravir is a generic version of Avigan® of Fujifilm Toyama Chemical Co. Ltd., Japan, a subsidiary of Fujifilm Corporation. Clinical trials have commenced and over 10 leading government & private hospitals in India are being enrolled for the study. Glenmark estimates study completion by July/August 2020. Glenmark has successfully developed the API and the formulations for the product through its in-house R&D team. Favipiravir has demonstrated activity against influenza viruses and has been approved in Japan for the treatment of novel influenza virus infections. The molecule if commercialized, will be marketed under the brand name 'FabiFlu®' in India. Commenting on this development, Dr. Monika Tandon, Vice President & Head, Clinical Development, Global Specialty/Branded Portfolio, Glenmark Pharmaceuticals Ltd., said, "Several health and medical experts, both in and outside of Glenmark are eager to see the effect that Favipiravir has on COVID-19 cases. We believe the study results will be significant as there is currently no effective treatment for the virus." She added, "The data we get from these trials will point us in a clearer direction with regard to COVID-19 treatment and management."   Further, Mr. Sujesh Vasudevan, President, India Formulations, Middle East and Africa, Glenmark Pharmaceuticals Ltd. mentioned, "Our effort is to launch a treatment for COVID-19 patients as soon as possible and control the spread of the pandemic. We will do all it takes to ensure accessibility of the product across the country if the clinical trials are successful." ]]> <![CDATA[Jubilant inks licensing deal with Gilead for Remdesivir]]> https://biospectrumindia.com/news/95/16437/jubilant-inks-licensing-deal-with-gilead-for-remdesivir.html https://biospectrumindia.com/news/95/16437/jubilant-inks-licensing-deal-with-gilead-for-remdesivir.html Wed, 13 May 2020 12:00:00 +0530 Jubilant Life Sciences Limited, an integrated global pharmaceutical and life sciences company, is pleased to announce that its subsidiary, Jubilant Generics Limited (“Jubilant”), has entered into a non-exclusive Licensing Agreement with Gilead Sciences, Inc. that will grant Jubilant the right to register, manufacture and sell Gilead’s investigational drug, remdesivir, a potential therapy for Covid-19 in 127 countries including India. These countries consist of nearly all low-income and lower middle-income countries, as well as several upper-middle and high-income countries that face significant obstacles to healthcare access. Under the licensing agreement, Jubilant will have the right to receive a technology transfer of the Gilead manufacturing process to scale up production to enable expedited access of the medicine to Covid-19 patients upon approvals by regulatory authorities in respective countries. Commenting on the partnership, Mr. Shyam S. Bhartia, Chairman and Mr. Hari S. Bhartia, Co-Chairman & Managing Director, Jubilant Life Sciences Limited, said, “We are very happy to strengthen our partnership with Gilead to license remdesivir, which, based on initial data, shows promise to be a potential therapy for Covid-19, a pandemic creating unprecedented health and economic crisis globally. We will be monitoring the clinical trials and regulatory approvals very closely and would be ready to launch the drug shortly after the required regulatory approvals. We also plan to produce the drug’s Active Pharmaceutical Ingredient (“API”) in-house helping its cost effectiveness and consistent availability.” Remdesivir, an investigational antiviral therapy developed by Gilead, received Emergency Use Authorization (EUA) by USFDA to treat Covid-19. The EUA will facilitate broader use of remdesivir to treat hospitalized patients with severe COVID-19 disease. The EUA is based on available data from two global clinical trials – US National Institute for Allergy and Infectious Diseases’ placebo-controlled Phase 3 study in patients with moderate to severe symptoms of COVID-19, and Gilead’s global Phase 3 study evaluating remdesivir in patients with severe disease. Multiple additional clinical trials are ongoing to generate more data on the safety and efficacy of remdesivir as a treatment for COVID-19. Remdesivir remains an investigational drug and has not been approved by USFDA. ]]> <![CDATA[Glenmark launches 3-in-1 inhaler therapy for COPD ]]> https://biospectrumindia.com/news/95/16424/glenmark-launches-3-in-1-inhaler-therapy-for-copd-.html https://biospectrumindia.com/news/95/16424/glenmark-launches-3-in-1-inhaler-therapy-for-copd-.html Tue, 12 May 2020 13:05:00 +0530 Glenmark Pharmaceuticals has announced the launch of a Single Inhaler Triple Therapy AIRZ-FF - a combination of two bronchodilators, Glycopyrronium & Formoterol and the inhalation corticosteroid Fluticasone propionate, for Chronic Obstructive Pulmonary Disease (COPD). This new triple therapy innovation comes with multiple benefits: it offers significant bronchodilation (making breathing easier), reduces risk of severe attacks, and eliminates dependence on multiple inhalers. The reduction in risk of severe attacks decreases the requirement for hospitalization, a benefit of high significance in current prevailing situation. AIRZ-FF has been exclusively studied in the Indian population1 and introduced to address challenges faced by a significant portion of COPD patients in the country. COPD is a very common, serious and debilitating lung disease which like hypertension or diabetes, requires personalized treatment over the rest of the patient’s life. India is currently home to more than 55.3 million people living with COPD of varying degrees of severity. The disease prevalence has grown significantly by 24% in the last decade alone. Health experts attribute this rise to low levels of awareness and low rates of diagnosis of the disease. Together these factors have made COPD the second leading cause of death by disease in India. Sujesh Vasudevan, President, India Formulations, Middle East and Africa at Glenmark Pharmaceuticals said, “COPD poses a significant public health challenge in India for many reasons. When it comes to treatment, there is poor patient compliance and adherence to prescribed doses, owing to the need for multiple inhalers through the day. By introducing AIRZ-FF, we hope to reduce this burden for patients, by delivering three effective therapies together in the same inhaler.” He added, “Glenmark continues to invent and innovate healthcare solutions that meet specific and often hard-to-address needs of patients in India and the world.” Of the global COPD burden, about 35% is attributed to tobacco smoking. The remaining 65% is seen in non-smokers, mostly living in low- and middle-income countries. In India, a substantial number of COPD cases occur in people who have never smoked. They have been ascribed to ambient air pollution, occupational exposure to dust and gases, poor living conditions, repeated respiratory tract infections and exposure to indoor biomass smoke. According to global organizations on respiratory medicine, patients most likely to benefit from triple therapy include those with history of multiple or severe attacks, despite appropriate use of singular or dual bronchodilators alone. ]]> <![CDATA[Zydus launches enzalutamide for prostate cancer therapy]]> https://biospectrumindia.com/news/95/16414/zydus-launches-enzalutamide-for-prostate-cancer-therapy.html https://biospectrumindia.com/news/95/16414/zydus-launches-enzalutamide-for-prostate-cancer-therapy.html Tue, 12 May 2020 05:00:00 +0530 Zydus Cadila, a global innovation driven healthcare company, announced that it is launching Enzalutamide, a highly effective drug for the treatment of Prostate Cancer, under the brand name ‘Obnyx’ in India. In a step that can significantly reduce treatment cost by almost 70%, the drug is priced at Rs 5995 (weekly therapy) reducing the monthly treatment cost to less than Rs. 27000. The current MRP of Enzalutamide drug ranges from Rs. 70000 to Rs 80000 for a monthly therapy and can be a huge financial burden for the elderly patients as they need to continue the therapy for a long period of time. This price reduction will benefit many prostate cancer patients to adhere to the treatment One of the important aspects of prostate cancer treatment is reducing the effect of androgens (a male reproductive hormone) on prostate gland. Many patients require Androgen Receptor Targeted Therapies like Enzalutamide which works by blocking the effects of androgen to stop the growth and spread of prostate cancer cells. More importantly, it is a preferred option in patients with significant liver, heart and kidney diseases which is very common in the elderly men. Enzalutamide has an advantage of being taken through oral route. Zydus’ Obnyx scores over other formulations in the market as it is a soft gel capsule filled with liquid, similar to the innovator drug. This has been specially developed through in-house efforts. The other formulations available in the market are hard gelatin capsules Prostate cancer is one of the leading cancer in males in India and the risk increases with age. About 1 out of 9 men have risk of developing prostate cancer in lifetime. The incidence is nearly 60% in men over the age of 65 years. Other risk factors such as obesity, family history and improper diet have been identified as the main contributing factors towards an increased incidence of prostate cancer.   ]]> <![CDATA[HLL Lifecare invites bids for COVID 19 testing kits]]> https://biospectrumindia.com/news/95/16431/hll-lifecare-invites-bids-for-covid-19-testing-kits.html https://biospectrumindia.com/news/95/16431/hll-lifecare-invites-bids-for-covid-19-testing-kits.html Tue, 12 May 2020 00:00:00 +0530 The pre-bid conference of Government Agency HLL Lifecare saw participation from over 100 companies interested in supplying medical supplies for CoVoid testing. HLL Infra Tech Services Limited (HITES), a fully owned subsidiary of HLL Lifecare Ltd. (HLL), on behalf of Indian Council of Medical Research has floated a tender seeking supply of over 10 million units of medical supplies towards the CoVid testing. The tender has requested for quotations for 4 million units of Viral Transport Media, 3.3 million of RNA extraction kits and 2.9 million of Combo RT-PCR COVID-19 Tests. HLL Lifecare is the procurement agency for the hospitals and healthcare organisations under the Ministry of Health & Family Welfare, Government of India. The last date of submission for the tender is May 17 within seven days of being floated. Over 85 companies were present on the virtual platform for the pre-bid conference while the remaining had sent representitives. The total value of the bid is expected to be above The Viral Transport Media is used for transport of Swabs collected for testing, RNA extraction kits are used to draw out RNA, which are single strand genetic materials of viruses, from samples which are then converted into reverse-transcribed into DNA while Combo RT-PCR tests has proven to be the ‘gold standard’ of covid-19 diagnosis This tender comes close on the heels of the Central Government amending rules in terms of testing. As per the new policy, very mild or mild and moderate patients can be discharged without COVID-19 test, subject to clinical conditions. The new rules come into effect as India braces for a jump in Coronavirus cases, with mathematical modeling showing the peak of infections may come in June-July.   ]]> <![CDATA[Bharat Biotech leads CSIR-NMITLI project to fight COVID-19]]> https://biospectrumindia.com/news/95/16399/bharat-biotech-leads-csir-nmitli-project-to-fight-covid-19.html https://biospectrumindia.com/news/95/16399/bharat-biotech-leads-csir-nmitli-project-to-fight-covid-19.html Fri, 08 May 2020 12:45:00 +0530 The Council of Scientific and Industrial Research (CSIR) under its flagship programme NMITLI has sanctioned a project to develop human monoclonal antibodies as therapy for COVID-19 infections. The project is being led by Bharat Biotech, a leading manufacturer of vaccines and bio-therapeutics as well as supplier of products to over 65 countries in the world. This programme brings together academia - National Centre for Cell Science (NCCS), Pune and Indian Institute of Technology, Indore and industry - PredOmix Technologies, Gurgaon and Bharat Biotech in a collaborative mode for a public health emergency. Although efforts are underway for the development of drugs and vaccines for controlling the COVID-19 pandemic, these are slow and expensive processes with uncertainties. Therefore, an alternate therapeutic regimen for early deployment is critical.  The present project aims at such an alternate therapeutic regimen by generating highly effective and specific human monoclonal antibodies that are capable of neutralizing the SARS-CoV2 virus. Such virus-neutralizing antibodies can block the spread of infection by binding to the virus and rendering it ineffective. Monoclonal antibody therapy is a highly effective and safe method.  Expressing his happiness on receiving CSIR-NMITLI approval of the project, Dr. Krishna Ella, Chairman & Managing Director Bharat Biotech said, “The purpose of vaccination is to protect the healthy against future infections and it alone may not provide the complete solution. We feel the monoclonal antibody therapy will provide a viable option.” “The question is of how to treat those individuals who are already infected? plus, we do not yet know how effective an anti-SARS-CoV2 vaccine will be in the elderly people and those with co-morbidities. Given the large number of Indians suffering from hypertension, diabetes, and heart diseases, this becomes an important issue.” Dr. Ella added. Talking about the novel antibodies approach to deal with COVID19 Pandemic Dr. Ella stated, “While both Israel and The Netherlands have recently announced the development of virus-neutralizing antibodies, our approach is to develop a powerful cocktail of neutralizing antibodies that can also simultaneously block mutational variants of the virus. We are fast-tracking the development process, to make the antibodies available within the next 6 months and thus improve the treatment efficacy”. Bharat Biotech has excelled in identifying potential viral threats, and have successfully developed 10 different Viral vaccines. As a Pandemic Vaccines frontrunner, the company has delivered more than 5 billion doses of viral vaccines including Anti Rabies vaccines. As an innovative company, Bharat Biotech continues to solve Public Health and Virulent Disease burden with new vaccines and therapeutic approaches, on its own, and through Public-Private Partnerships. ]]> <![CDATA[‘Lock Out’ pain through Combiflam® Plus’ newest digital campaign #LockdownWaaliLife]]> https://biospectrumindia.com/news/95/16403/lock-out-pain-through-combiflam-plus-newest-digital-campaign-lockdownwaalilife.html https://biospectrumindia.com/news/95/16403/lock-out-pain-through-combiflam-plus-newest-digital-campaign-lockdownwaalilife.html Fri, 08 May 2020 00:00:00 +0530 Combiflam®, India’s most trusted pain relief brand took on an unusual and quirky route to promote Combiflam® Plus – its OTC variant for headache relief. Roping in influencers across Instagram, TikTok and Facebook, the campaign highlights the struggles and tussles of working-from-home and working-at-home, both at the same time. The campaign aims to connect with millennials who spend a fair share of their time on these channels. Popular influencers like Bharti, Shehnaaz Gill, Hina Khan, Sristhy Rode, Ishita Dutta, Sunny Chopra, Faisu, Awez Darbar and Sonam Gill are amongst the many who are creating and uploading humourous home-videos that capture the dilemma of leading an indoor life for a generation that has never had to do so before. The campaign has also extended reach through several posts and banner advertisements on the same theme, across various social media platforms.  The campaign is expected to garner a total reach of more than 24 million. Needless to say, the videos also convey an appeal to its viewers to maintain social distancing, stay at home and stay safe. Speaking about the campaign, Nikhilesh Kalra, General Manager, Consumer Healthcare, Sanofi, said, ““No amount of messaging on how to stay safe during this pandemic is enough. Everyone has received the strong and serious messages from the Government, news and social channels.  However, this has required a lot of adjustment and consequent physical and mental pain for us. Many of us are not used to doing household chores along with the rigour of working-from-home or studying-at-home or whatever-at-home. Combiflam® Plus understands the pain that Indians go through in their day to day life. This campaign demonstrates this understanding. In a light and humorous ways, we are telling everyone that while we may not be able to make all the lockdown related pains go away, for any physical pain Combiflam® Plus is always there for you.” Elaborating on the campaign, Elizabeth Dias and Srreram Athray, Group Creative Directors, Ogilvy said, “Combiflam® Plus stands for pain relief. And with the lockdown in place, everyone is experiencing pain of varying kinds. So, we thought it would be a good idea for the brand to help relieve some of this pain through a bit of humour and empathy. When we all go through the same pain, we can discuss it and have some fun. Since traditional media was currently out of question, we used some entertaining people and social media to take the message into everyone’s homes.” ]]> <![CDATA[Sai Life Sciences joins COVID Moonshot Project ]]> https://biospectrumindia.com/news/95/16388/sai-life-sciences-joins-covid-moonshot-project-.html https://biospectrumindia.com/news/95/16388/sai-life-sciences-joins-covid-moonshot-project-.html Thu, 07 May 2020 11:25:00 +0530 Hyderabad based Sai Life Sciences, Contract Development & Manufacturing Organizations (CDMOs) has announced its collaboration with the COVID Moonshot project that aims to deliver an antiviral drug candidate effective against COVID-19. With an in-kind contribution of a team of Medicinal Chemists and supporting infrastructure, Sai Life Sciences will help synthesize and profile analogues for NCEs and other previously known compounds tested for other viruses. PostEra, a US based biotechnology company specialising in machine learning for drug discovery, is leading the initiative. Joining them are leading experts in the fields of computational drug discovery, chemical synthesis and biochemical assays. In the three months since its start in February this year, the team has already identified over 60 experimentally-confirmed 'fragments' that effectively target a key protein associated with COVID-19. It has now opened a crowdsourcing initiative to accelerate the design of potential drug candidates from these fragments and received over 4,000 submissions from contributors around the world. Welcoming Sai Life Sciences into the consortium, CEO of PostEra, Aaron Morris, said, "We are immensely grateful for Sai Life Sciences' contribution to this project. They are helping take the most promising crowdsourced ideas from the Moonshot platform and turning these ideas into chemical reality. It is generosity like this that gives us hope that this moonshot of a project could achieve something ground-breaking in our search for an effective COVID antiviral." Speaking about its participation in the project, CEO & Managing Director of Sai Life Sciences, Krishna Kanumuri said, "We are delighted to join this important global initiative. The consortium approach to finding treatments for patients in the fight against COVID-19 is a worthy cause and something that aligns very well with our purpose of working with partners to accelerate solutions for improving life." Over the past two decades, Sai Life Sciences has built up a portfolio of NCE Discovery services on the foundation of a strong chemical synthesis platform. The company today offers innovator biotechs and pharmaceutical companies the full spectrum of Discovery services from Target ID & Validation through till IND, in addition to a robust suite of capabilities across NCE development and cGMP manufacturing.  ]]> <![CDATA[Glenmark to conduct clinical trials with Favipiravir]]> https://biospectrumindia.com/news/95/16357/glenmark-to-conduct-clinical-trials-with-favipiravir.html https://biospectrumindia.com/news/95/16357/glenmark-to-conduct-clinical-trials-with-favipiravir.html Mon, 04 May 2020 05:05:00 +0530 Glenmark Pharmaceuticals has announced that it has received approval from the DCGI (Drug Controller General of India), the regulator in India to conduct clinical trials on Favipiravir Antiviral tablets on COVID-19 patients. The product is a generic version of Avigan® of Fujifilm Toyama Chemical Co. Ltd., Japan, a subsidiary of Fujifilm Corporation. Favipiravir has demonstrated activity against influenza viruses and has been approved in Japan for the treatment of novel influenza virus infections. Recently in the past few months, post the outbreak of COVID-19, multiple clinical trials have been initiated on COVID-19 patients in China, Japan and in the US. Having internally developed the API and the formulations for the product, Glenmark filed the product for clinical trials with the DCGI and has received approval for conducting the trial on mild to moderate patients. As on date, Glenmark is the first pharmaceutical company in India to be given an approval by the regulator to start the trial on COVID-19 patients in India. Sushrut Kulkarni, Executive Vice President – Global R&D, Glenmark Pharmaceuticals Limited said, “After having successfully developed the API and the formulations through its in-house R&D team, Glenmark is all geared to immediately begin clinical trials on Favipiravir on COVID-19 patients in India. The clinical trial will let us know the efficacy of this molecule on COVID-19 patients.” He also added, “If the clinical trials are successful, Favipiravir could become a potential treatment for COVID-19 patients.” As per the clinical trial protocol approved, 150 subjects with mild to moderate COVID-19 will be randomized in the study in a 1:1 ratio to Favipiravir with standard supportive care or standalone standard supportive care. Treatment duration is a maximum of 14 days and the total study duration will be maximum for 28 days from randomization. ]]> <![CDATA[Shahlon Silk Industries to manufacture fabric for PPE ]]> https://biospectrumindia.com/news/95/16360/shahlon-silk-industries-to-manufacture-fabric-for-ppe-.html https://biospectrumindia.com/news/95/16360/shahlon-silk-industries-to-manufacture-fabric-for-ppe-.html Fri, 01 May 2020 18:10:00 +0530 Surat based Shahlon Silk Industries Limited, manufacturers of Man-made Fibre and Fabric in India, has received certification from the South India Textile Research Association (SITRA) for manufacturing of fabric meant for body coverall of Personal Protective Equipment (PPE) for Covid-19 pandemic. The company has overall woven fabric manufacturing capacity of 42 million meter per annum. The capacity will cater to the augmented demand for the PPE kits required for healthcare professionals attending to infected patients in isolation wards & the Intensive Care Units (ICU) and all the other National Healthcare services volunteers. The company has the capacity and capabilities to manufacture PPE in addition to PPE fabric under the existing manufacturing setup without any further CAPEX/ investment. The company is in the process for approval of manufacturing protective suits from the respective nodal agency for PPE. This product caters to wide range of protective apparels for medical, pharma, biotechnology, electronics and food & beverage industry. Commenting on the development, Dhirubhai Shah, Chairman, Shahlon Silk Industries Ltd. said, “Shahlon group, over the past few years, has focused on developing value added products and maintaining the quality, due to which we have gained a respectable name in the industry. The existing fabric manufacturing capacities would be utilized for manufacture of the fabric meant for PPE as service to humanity during the time of this pandemic. The certification confirms the requirement of Ministry of Health & family welfare guidelines dated 02.02.2020.”   ]]> <![CDATA[Premas biotech to develop vaccine against COVID-19]]> https://biospectrumindia.com/news/95/16355/premas-biotech-to-develop-vaccine-against-covid-19.html https://biospectrumindia.com/news/95/16355/premas-biotech-to-develop-vaccine-against-covid-19.html Fri, 01 May 2020 10:45:00 +0530 A team of researchers led by IIT Bombay alumnus Dr. Prabuddha Kundu, at Gurgaon based Premas Biotech, is developing a triple antigen vaccine. They have successfully identified three major antigens as a recombinant novel coronavirus vaccine candidate. Unlike single-protein vaccines currently under trials across the world, Premas Biotech has adopted a three-pronged approach to develop multi subunit vaccine, using recombinantly expressed antigens Spike (S), Envelope (E), and Membrane (M) proteins in multiple formats, which it hopes will provide a good chance of immunity against Covid-19. Premas has successfully completed expression of the three coronavirus antigens and is now moving forward with developing the scale up designs and is applying for animal trials. The multi-antigenic approach is being designed to try to overcome presently known and possible future mutations of novel coronavirus, which, if successful, would result in the development of an effective vaccine. Based on an exclusive D-Crypt™ technology that is developed and improved upon by Premas Biotech over the past decade, a modified version of baker’s yeast or Saccharomyces cerevisiae is being used to recombinantly produce the antigens, thus making the potential vaccine relatively easy to manufacture and produce at a mass scale to cater to large populations, not only in India but all over the world. Baker’s yeast grows fast, is more cost-effective as compared to other modern technologies and has been viewed as a safe compound by regulatory agencies like the US-FDA and DCGI in other drugs. Specifically, a yeast host platform has been successfully used to produce many drugs, including drugs like insulin and many blood products and hormones. “Using D-Crypt™ technology, we believe that we can produce multi million doses a week if the vaccine is approved, as drug manufacturers are used to this platform and there are many existing facilities and processes that can be used for such production. With this technology and collective knowledge of over three decades of usage of yeast as a host, we at Premas were able to express the three antigens in multiple formats in less than two months. We are working closely with our partners and the authorities to plan and role out our next steps.” said Dr.Kundu Dr. Nupur Mehrotra, Premas Biotech Co-Founder said, “Since yeast is used for expression and development of the vaccine, we believe that our technology will be more affordable than other vaccine candidates being developed and easier to manufacture. We believe that this could be the first triple antigen composition that will come from an Indian company, ready for the world.” Under the stewardship of Dr. Prabuddha Kundu, Premas Biotech has partnered with global companies on path breaking technologies, such as their partnership with Oramed Inc., as only manufacturer of the proteins required for Oral Insulin, which has successfully cleared Phase IIb trials in US.   ]]> <![CDATA[Strides commences export of Favipiravir tablets ]]> https://biospectrumindia.com/news/95/16351/strides-commences-export-of-favipiravir-tablets-.html https://biospectrumindia.com/news/95/16351/strides-commences-export-of-favipiravir-tablets-.html Fri, 01 May 2020 10:10:00 +0530 Bengaluru based Strides Pharma Science Limited, a global pharmaceutical company has announced that it has developed and commercialized Favipiravir Antiviral tablets. The product is a generic version of Avigan® of Toyama Chemical, Japan. Favipiravir is an antiviral medication that was initially developed to treat influenza in Japan. In February 2020, post the outbreak of Novel Coronavirus (Covid-19), Favipiravir was studied in China and several other countries as an experimental treatment of Covid-19. The drug has demonstrated positive outcomes, including a reduction in the duration of Covid-19 and improved lung conditions for the patients. Strides has developed Favipiravir tablets in 400mg and 200mg strengths for convenient dosage administration. The product is currently being exported to GCC countries to treat patients under their treatment program for Covid-19. Strides will also immediately apply to Indian Drug Authorities to commence necessary studies and make the drug available to Indian patients expeditiously. Favipiravir tablets are being manufactured at Strides’ flagship facility in Bengaluru, India. The facility can produce up to 6 billion units of solid orals annually and is approved by USFDA, MHRA, WHO, TGA among others. Strides has also entered into a preferred arrangement with a leading Indian API manufacturer for the supplies of Favipiravir API. The partner has already commercialized the Favipiravir API from its USFDA, KFDA, PMDA and WHO approved manufacturing facility and has capabilities to manufacture the Favipiravir API from its Key Starting Material (KSM) in-house. ]]> <![CDATA[IIT-G, Hester Biosciences to develop COVID-19 vaccine]]> https://biospectrumindia.com/news/95/16343/iit-g-hester-biosciences-to-develop-covid-19-vaccine.html https://biospectrumindia.com/news/95/16343/iit-g-hester-biosciences-to-develop-covid-19-vaccine.html Thu, 30 Apr 2020 09:00:00 +0530 Indian Institute of Technology Guwahati (IIT-G) is collaborating with Hester Biosciences Limited, a pharmaceutical company based in Ahmedabad, Gujarat, to work on the vaccine development against COVID-19. The agreement between the two parties was signed on 15th April 2020. The vaccine will be based on recombinant avian paramyxovirus-based vector platform. The recombinant avian paramyxovirus-1 will be used to express the immunogenic protein of SARS-CoV-2. The recombinant avian paramyxovirus-1 expressing the SARS-CoV-2 protein could be used as a vaccine candidate for further study. The avian paramyxovirus-1 has been explored as a vaccine vector for various animals and human pathogens. The avian paramyxovirus-1 has been used to express the immunogenic protein of human pathogens such as HIV, avian influenza virus, human parainfluenza virus, SARS-CoV. Similarly, it has also been explored as a vaccine vector for animal pathogens such as infectious bursal disease virus, infectious laryngotracheitis virus, bovine herpes virus, Nipah virus etc. The team at IIT Guwahati is headed by Dr. Sachin Kumar, Associate Professor, Department of Biosciences and Bioengineering. The team has generated the recombinant avian paramyxovirus-1 based vaccine flatform for Classical Swine Fever and Japanese encephalitis. The role of the Institute is to produce the recombinant vaccine candidate. Speaking about the vaccine for COVID-19, Dr. Sachin Kumar said, “It is too early to comment on the efficacy and immunogenicity of the vaccine; however, we will be able to reveal more details about this vaccine after the results of animal studies are obtained.” Speaking about the collaboration and role of Hester Biosciences Limited, Rajiv Gandhi, CEO and MD, Hester Biosciences Limited, said, “In the current pandemic situation of COVID-19, the world is looking at developing preventive and curative measures to safeguard mankind. IITG & Hester have collaborated to develop and manufacture a recombinant vaccine against COVID-19 disease as a preventive measure. Hester’s involvement would be from master seed development up to release of the commercial vaccine”. He further added, “Hester has 23 years of experience in vaccine manufacturing on the veterinary side. It manufactures vaccines by using fermentation, tissue culture, continuous cell line and chick embryo origin methods. Hester is also currently working towards developing next generation recombinant poultry vaccines. Being in veterinary vaccine manufacturing, as well as working towards developing recombinant vaccines, Hester has a fairly good understanding and the capability to get into human vaccines, specifically into a vaccine against the COVID-19 disease.” IIT Guwahati and Hester Biosciences Limited expect the vaccine to be ready by the end of this year to start animal studies. The work is currently in its early stage of development.   Prof. T. G. Sitharam, Director, IIT Guwahati, is hopeful that the outcome of this important collaboration will be a win-win situation for the country and will lead to breakthrough results in prevention of COVID-19 as well as provide leads for vaccine developments against other diseases as well in immediate future.   ]]> <![CDATA[Biocon and Mylan launches biosimilar Fulphila in Canada ]]> https://biospectrumindia.com/news/95/16344/biocon-and-mylan-launches-biosimilar-fulphila-in-canada-.html https://biospectrumindia.com/news/95/16344/biocon-and-mylan-launches-biosimilar-fulphila-in-canada-.html Wed, 29 Apr 2020 13:25:00 +0530 Biocon and Mylan has announced the launch of Fulphila®, a biosimilar to Neulasta® (pegfilgrastim). Fulphila is approved by Health Canada to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-neoplastic drugs. The approval of Fulphila was based on a comprehensive package of analytical, nonclinical and clinical data, which confirmed that the product is highly similar to Neulasta and no clinically meaningful differences in terms of safety and efficacy exist. Dr Christiane Hamacher, CEO, Biocon Biologics, CEO said, “We are pleased to expand access to our high quality biosimilar pegfilgrastim to patients in Canada, after a successful launch in the US. This is the second biosimilar from our portfolio to be launched in Canada by our partner Mylan and is an endorsement of our science, development and manufacturing capabilities in the area of biologics. We are committed to serve 5 million patients through our biosimilars portfolio and cross a revenue milestone of US$1bn by FY22.” David Simpson, Country Manager, Mylan Canada commented, “As a global leader in the development of complex products, including biosimilar medicines, Mylan is proud to launch Fulphila in Canada.  We have reached a negotiated agreement with the Pan-Canadian Pharmaceutical Alliance (pCPA) to help expand access to treatment and reduce costs for cancer patients. Fulphila is the second biosimilar to be offered by Mylan through the Mylan-Biocon Biologics partnership in Canada and the second biosimilar approved by Health Canada through this collaboration to support cancer patients. With Mylan’s global portfolio of 20 biosimilar and insulin analog products in development or on the market, we are bringing vast biosimilars experience to the market here in Canada. Among these products is an extensive oncology portfolio increasing choice and access for patients across the region.” A suite of patient services will be available at launch to further support patients and caregivers with treatment. Mylan and Biocon Biologics are exclusive partners on a broad portfolio of biosimilar and insulin products. Biosimilar pegfilgrastim is one of the 11 biologic products being co-developed by Mylan and Biocon for the global marketplace. Mylan has exclusive commercialization rights for the product in the U.S., Canada, Japan, Australia, New Zealand and in the European Union and European Free Trade Association countries. Biocon has shared or co-exclusive commercialization rights with Mylan for the product in the rest of the world.   ]]> <![CDATA[Glenmark receives ANDA tentative approval for generic version of Qtern ]]> https://biospectrumindia.com/news/95/16341/glenmark-receives-anda-tentative-approval-for-generic-version-of-qtern-.html https://biospectrumindia.com/news/95/16341/glenmark-receives-anda-tentative-approval-for-generic-version-of-qtern-.html Wed, 29 Apr 2020 11:50:00 +0530 Glenmark Pharmaceuticals has been granted tentative approval by the United States Food & Drug Administration for Dapagliflozin and Saxagliptin Tablets, 10 mg/5 mg, the generic version of Qtern Tablets, 10 mg/5 mg, of AstraZeneca AB. According to IQVIATM sales data for the 12-month period ending February 2020, the Qtern Tablets, 10 mg/5 mg market achieved annual sales of approximately $10.4 million. Glenmark’s current portfolio consists of 162 products authorized for distribution in the U.S. marketplace and 44 ANDA’s pending approval with the USFDA.   ]]> <![CDATA[IICT to reduce dependency for APIs]]> https://biospectrumindia.com/news/95/16337/iict-to-reduce-dependency-for-apis.html https://biospectrumindia.com/news/95/16337/iict-to-reduce-dependency-for-apis.html Wed, 29 Apr 2020 10:10:00 +0530 Active pharmaceutical ingredients (APIs) and intermediates are the key components of any drug that produces the intended effects. India is largely depended especially on China for supply of APIs and drug intermediates. Now Indian Institute of Chemical Technology (IICT), Hyderabad, is collaborating with another Hyderabad-based integrated pharmaceutical company, LAXAI Life Sciences, to develop and manufacture APIs and drug intermediates. The initiative may help in reducing the dependency of the Indian pharmaceutical sector on Chinese imports of these ingredients. IICT, a laboratory under the Council of Scientific and Industrial Research (CSIR), is working with LAXAI for synthesis of drugs being used in the fight against the Corona Virus.  The collaboration will primarily focus on Umifenovir, Remdesivir and a key intermediate of Hydroxy Chloroquine (HCQ).  India, one of the largest producers of anti-malarial drug HCQ, has seen a spurt in demand in the recent weeks. India has sent HCQ to over 50 countries over the last few days, including the United States. The collaboration will result in a cost-effective process with minimal dependency on China for key raw materials. In addition, Remdesivir, which has been previously administered to Ebola virus patients, is currently under clinical trials to evaluate efficacy and safety against COVID -19.  Realizing that drug security and undisrupted access to essential medicines are critical for public health, the Union Cabinet chaired by the Prime Minister, has approved a special package for promotion of bulk drug manufacturing in India and reduction of our dependence on China. The collaboration will use the know-how for commercial manufacturing of the products. LAXAI Life Sciences shall be one of the first few to commercialize these products.  The manufacturing of these APIs and intermediates will be taken up at U.S. Food and Drug Administration (USFDA)/Good manufacturing practice (GMP) approved plants held by LAXAI through its subsidiary, Therapiva Private Limited. ]]> <![CDATA[Lincoln Pharma receives approval to manufacture HCQ]]> https://biospectrumindia.com/news/95/16321/lincoln-pharma-receives-approval-to-manufacture-hcq.html https://biospectrumindia.com/news/95/16321/lincoln-pharma-receives-approval-to-manufacture-hcq.html Tue, 28 Apr 2020 08:25:00 +0530 Lincoln Pharmaceuticals Limited has received approval to manufacture Hydroxychloroquine (HCQ) among other critical drugs to fight COVID 19. Company received approval from Food & Drug Control Administration, Gujarat to manufacture varied dosages of Hydroxychloroquine Tablets and Hydroxychloroquine Sulfate Tablets among others at its plant in Khatraj in Ahmedabad. After necessary approval from Directorate General of Foreign Trade (DGFT) company will be able to export these products. Food & Drug Control Administration, Gujarat approved manufacture of following drugs from Lincoln Pharma's Khatraj facility. Hydroxychloroquine Sulfate Tablets USP in 200 MG, 300 MG and 400 MG dosages. Hydroxychloroquine Tablets IP in 200 MG, 300 MG and 400 MG dosages respectively. Mahendra Patel, Managing Director, Lincoln Pharmaceuticals Limited, said, "We have all the necessary infrastructure at our state-of-the-art manufacturing facility at Khatraj, Ahmedabad and look to expedite the commercial production of the approved drugs at the earliest. Company is committed to fight the COVID-19 pandemic and working closely with the governments and relevant stakeholders to ensure uninterrupted supply of medicines. Company has also constituted a task force to handle the distribution of medicines and essential drugs with the primary objective of dealing with any kind of emergency or distress situation by COVID-19." HCQ is a prescription based drug commonly recommended to Corona patients under treatment for the disease. India is the largest producer of HCQ and taking a lead in supplying this to the world in this time of crisis. Lincoln Pharmaceuticals Ltd develops and manufactures affordable and innovative medicines for healthier lives. The company has developed 300 plus formulations in 15 therapeutic areas and has a strong product/brand portfolio in anti-infective, respiratory system, gynaecology, cardio & CNS, antibacterial, anti-diabetic, anti-malaria among others. Company has filled 20 plus patent applications and is awarded five patents. Company has presence in more than 60 countries encompassing Africa, Central America and Southeast Asia.  ]]> <![CDATA[Syngene opens COVID-19 RT-PCR test centre in Bengaluru]]> https://biospectrumindia.com/news/95/16328/syngene-opens-covid-19-rt-pcr-test-centre-in-bengaluru.html https://biospectrumindia.com/news/95/16328/syngene-opens-covid-19-rt-pcr-test-centre-in-bengaluru.html Mon, 27 Apr 2020 21:00:00 +0530 Syngene International Ltd., a global research and development services company, has announced the opening of a COVID-19 testing laboratory at its Bengaluru site. In less than six weeks, the company used its expertise in clinical trial management, human clinical sample testing procedures, molecular biology and viral testing to gain the additional approvals, including ICMR approval, necessary to open the facility to support hospitals in the city. Commenting on the development, Dr Mahesh Bhalgat, Chief Operating Officer, Syngene International Ltd., said, “As India battles the COVID-19 pandemic, we are proud to contribute our scientific expertise and resources in supporting the nation in this hour of need. Our COVID-19 testing laboratory, using RT-PCR technology, will work with local hospitals to expand the testing capacity in Bengaluru and help reduce the spread of the virus in the community. The laboratory will be scaling up to operate round-the-clock sample processing and all tests will be offered free of charge.” Syngene has repurposed one of its laboratories to conduct the RT-PCR tests. A dedicated team of scientists has been trained to perform these tests as per the guidelines prescribed by national and global regulatory authorities. Necessary processes have been established for safe handling of the samples and testing kits have been sourced and validated. With the broad range of scientific expertise in relevant disciplines that Syngene offers, it is also working to supply reagents, primers and probes for COVID-19 diagnostic testing to clients, as well as working on research projects related to vaccine development which could represent a longer-term solution for fighting the coronavirus pandemic. RT-PCR or Real Time PCR is an advanced technology which is used to detect the expression level of the relevant RNA fragment. It monitors the amplification of a targeted oligonucleotide sequence in real-time and uses fluorescent dyes to detect the presence of the virus. At present, there are 277 government laboratories approved and supported by the ICMR and 16 private labs for testing Coronavirus including 6 in Bangalore. ]]> <![CDATA[Serum Institute to initiate COVID-19 vaccine trial in few weeks]]> https://biospectrumindia.com/news/95/16320/serum-institute-to-initiate-covid-19-vaccine-trial-in-few-weeks.html https://biospectrumindia.com/news/95/16320/serum-institute-to-initiate-covid-19-vaccine-trial-in-few-weeks.html Mon, 27 Apr 2020 10:00:00 +0530 Pune based vaccine maker Serum Institute of India (SII) has partnered with the University of Oxford in the UK for the COVID-19 vaccine trial.  University of Oxford researchers have begun testing a COVID-19 vaccine in human volunteers in Oxford. The vaccine is based on an adenovirus vaccine vector and the SARS-CoV-2 spike protein, and has been produced in Oxford. SII is hoping to bring this product to India in a few weeks and start the trials, based on the success of the UK trials. But even before the result for the trials is out in the UK, the company is planning to start manufacturing the vaccine by next month, in order to save time. SII is co-ordinating with the Indian Council of Medical Research (ICMR) to go ahead with the vaccine trials in India. "Normally vaccine development is a long process, but the regulatory approvals in India have been very carefully changed in the current scenario, for the COVID-19 vaccine development. The University of Oxford researchers have begun testing a COVID-19 vaccine in human volunteers in Oxford. If these trials are successful in the UK, we will start a trial in India. After we get positive results in these trials in India, then the COVID-19 vaccine will be made available by Oct- Nov. This is also dependent on the fact we will have to start producing the vaccine at our personal cost by next month. We hope to build up 40 million doses by Sept- Oct in the hope that if the trials work, then we have the product ready. Typically, one first waits for the trials to get over, and then start the manufacturing process, but that would be a longer wait. So yes, we are starting the manufacturing process early with 4-5 million doses. This way we shall be able to have a decent amount ready by October", reveals Adar Poonawalla, CEO, SII. SII will be using a temporary facility to carry out the COVID-19 vaccine production. An exclusive facility for this vaccine will eventually be built in 2-3 years. ]]> <![CDATA[StayHappi Pharmacy to launch online platform for generic medicines]]> https://biospectrumindia.com/news/95/16310/stayhappi-pharmacy-to-launch-online-platform-for-generic-medicines.html https://biospectrumindia.com/news/95/16310/stayhappi-pharmacy-to-launch-online-platform-for-generic-medicines.html Fri, 24 Apr 2020 12:10:00 +0530 StayHappi Pharmacy, an initiative of SarvaGunAushdhi Pvt Ltd is all set to launch its online store and make medicines accessible at affordable prices to people at their doorstep. Arushi Jain, executive director of StayHappi Pharmacy said, "COVID-19 has made all of us more conscious of our spendings. StayHappi Pharmacy App allows people to Compare & Save up to 30 to 90 percent on their medical bills. We are ready to work day and night and make affordable medicines accessible to people during this difficult time. The Stayhappi Online Pharmacy will first launch in Delhi, Gurugram, and Haridwar and as the lockdown unfolds, gradually across India. In line with Prime Minister’s vision of affordable medicines, and compliance with the guidelines issued by MCI and DCGI, StayHappi pharmacies will also sell generic unbranded medicines which are exactly the same in efficacy, safety, purity, dosage form and strength, route of administration, quality, performance characteristics, and intended use, as that of any best quality branded medicine in the country. The pharmacy believes that the products will rule the market only when they conform to the quality requirement of every customer – first time and every time, meeting world-class standards. “All our products are WHO-GMP, ISO NABL certified and from the best of India’s manufacturers. We offer Quality Medicines – that are affordable” said Arushi Jain StayHappi Pharmacy APP will provide for medicines for all major therapeutic segments like anti-diabetic, respiratory, gynecology, cardiac, CNS, gastrointestinal, antihypertensives, antibiotics, etc., while also providing consultation facility from renowned practitioners to help maximize benefits for patients. ]]> <![CDATA[Lupin Foundation contributes in combating COVID-19]]> https://biospectrumindia.com/news/95/16312/lupin-foundation-contributes-in-combating-covid-19.html https://biospectrumindia.com/news/95/16312/lupin-foundation-contributes-in-combating-covid-19.html Fri, 24 Apr 2020 12:00:00 +0530 At a time when our country is fighting an unprecedented battle with Covid-19, Lupin Human Welfare and Research Foundation, the CSR arm of pharma company Lupin Limited, has undertaken several initiatives across the country, at a district level, to help people during the global pandemic. Right from coordinating with district administration and collectors, to providing food and other necessary items to the migrant workers, poor and homeless, the Lupin Foundation team has been working relentlessly. PAN India: To prevent the spread of the Covid-19 virus, the team is producing and distributing masks and hand sanitizers. Additionally, awareness generation is also being done through various means. The Foundation is closely working with another trinity of the government – The Collectors, Superintendent of Police (SPs) and Chief Medical Officers (CMOs) around the country, which has made their programme more effective and acceptable for resource mobilisation. Through the efforts of Lupin Foundation, 11 districts in India were able to raise funds of INR 55,06,230, out of which INR 36,92,440 was raised by Lupin Foundation alone. State- District wise initiatives: Rajasthan: Bharatpur and Dholpur:    Bharatpur: The district was able to raise funds of INR 31,09,644, out of which INR 10,98,094 was raised by Lupin Foundation alone Lupin Foundation is helping in providing food not only to the people, but to the animals as well. The Foundation provided 12 qtl dry fodder & 3 qtl green fodder, 45 kg Bajara and Jowar grain to birds and 42 kg banana & 5 kg Chana to monkeys in the district. The Foundation along with the District Collector are educating the people about the importance of Social Distancing and Washing Hands. They are also spreading mass awareness by distributing & pasting flexes & pamphlets Overall, the Foundation distributed 4000 face masks, 2670 hand gloves, 2480 sanitizers, 3376 food ration kits to daily wage workers, 1200 Food packets to migrant workers and 7487 reusable face masks to the community   Dholpur: Manjari Foundation, an NGO in Dholpur, contributed Rs.51,000/- for the relief work o Lupin Foundation collaborated with Manjiri Foundation and started a community kitchen to serve food to the poor and needy Overall, the Foundation provided 1500 masks, 750 hand gloves and 750 sanitizers   Alwar: The district was able to raise funds of INR 9,26,840, out of which INR 7,32,020 was raised by Lupin Foundation alone Matashree Gomati Devi Jan Seva Nidhi (An NGO part of Lupin Foundation) provided 50 umbrellas at all Police checkpoints to help them beat the heat while being on duty o Overall, the Foundation provided 1500 masks, 500 hand gloves and 600 sanitizers in the district   Maharashtra: Pune: The district was able to raise funds of INR 6,88,221, out of which INR 6,71,401 was raised by Lupin Foundation alone Lupin Foundation distributed food grain kits to 13 poor families in Nande village, Mulshi Distributed masks, gloves and sanitizers to waste segregation plant workers in Pune Distributed 1600 bottles of sanitizers to the police officials, petrol pump workers and local cleaning workers in Junnar block Distributed 1020 triple layer disposable masks and 510 nitrile gloves to Police and government officials in Mulshi   Aurangabad: An amount of INR 5 lakh was donated by Lupin Ltd., Aurangabad to Dr. Bhagwat Karad, Rajya Sabha MP from Aurangabad. This donation is being utilised for food distribution to the poor and migrant labours through 9 food centres opened by him in Aurangabad feeding more than 3000 people daily. The food centre at his hospital is also providing food to 750 poor families in Samta Nagar slum area.   Dhule: Lupin Foundation was able to raise funds of INR 3,73,600 in the district o COVID-19 Has Caused A Shortage Of Face Masks. A group of 10 women employed by the Foundation, have stitched 2600 masks and have a target of achieving 10,000 masks in order to help the rural communities The field staff of Lupin Foundation along with their families are working all day, to stitch masks and distribute them free of cost The Foundation distributed 100 food ration kits to the ultra-poor families of the Sakri block   Tarapur: Lupin Foundation was able to raise funds of INR 1,61,000 in the district The Foundation distributed food grain kits to 200 poor families in Pam village Provided 5000 masks to PHC Police station and in the village   Sindhudurg: The district was able to raise funds of INR 60,000, out of which INR 50,000 was raised by Lupin Foundation alone The Foundation provided 171 Food kits to migrant labourers at Shiroda village, Vengurla   Nandurbar: The district was able to raise funds of INR 8,775, out of which INR 3,675 was raised by Lupin Foundation alone Provided sanitizers to the police department   Nagpur: Lupin Foundation was able to raise funds of INR 2500 in the district   Madhya Pradesh: Mandideep: Distributed 125 ration kits in cluster villages of block Obedullaganj, to all needy, handicapped, widow headed families and landless farmers The Foundation is providing N95 masks to Doctors   Vidisha: Distributed 50 Food ration kits and masks to poor families in cluster villages of Sironj block   Uttarakhand: Haridwar: The Foundation provided 200 face masks and 50 sanitizers to the main police station at Bahadarabad, Haridwar In the health center of the same region the Foundation donated 500 masks, 150 bottles of sanitizers and 300 gloves   Andhra Pradesh: Vizag: Lupin Foundation handed over 100 litres of hand sanitizer to M P (Member of parliament, Anakapalle) Dr BV Satyavathi Madam to distribute to Doctors & Nurses, Police, Sanitary workers etc. who are fighting against COVID-19. Distributed 40 litres of Sanitizer to Fishermen at Thikkavanipalem village in Parawada Mandal For Widows, Disabled, Kidney patients and 60 poor & needy families, the Foundation distributed grocery kits in two villages (Near LHWRF Skill training center) at pharmacity colony. ]]> <![CDATA[Essilor India donates 7.5 Million to PM Care Fund]]> https://biospectrumindia.com/news/95/16300/essilor-india-donates-7-5-million-to-pm-care-fund.html https://biospectrumindia.com/news/95/16300/essilor-india-donates-7-5-million-to-pm-care-fund.html Thu, 23 Apr 2020 18:15:00 +0530 Essilor, ophthalmic optics company has come forward to fight against COVID-19 and donated INR 7.5 Million for the Prime Minister’s CARES Fund. Essilor is also supporting Government in their efforts to contain the novel coronavirus pandemic in the country. The company has deployed multiple initiatives for those who are working as front-line responders and care givers of COVID-19 pandemic. These include the donation of 8000 Plano Eye Glasses to different State departments and other frontline responders and caregivers of COVID-19, which will help to minimize the direct exposure of eyes to the virus. Essilor is also supporting the Health Department by distributing over 500 surgical gloves, 500 face Shields masks and sanitizers to BBMP and other NGOs. Maarten Geraets, CEO, Essilor India said, “During this unprecedented crisis, it requires a collective and collaborative effort from all to respond to the COVID-19 pandemic in the best capacity. Corporates, Philanthropic organizations must come together to act swiftly to ensure food and medical aid is made available to those who need it the most. Essilor as a socially responsible corporate has stepped forward to make a meaningful contribution in these efforts of the government and supported India and those in gravest need. I would also like to take this opportunity to thank all employees for their generous contribution to the overall Essilor initiative for the PM CARES FUND. We stand together with India, and together we shall overcome this." Additionally, Essilor is responding to the COVID-19 outbreak with a humanitarian responsibility to Health staffs, BBMP staffs, and Para medical workers and has appreciated their efforts of risking their own lives to treat the vulnerable among us. In wake of the ongoing lockdown to mitigate the Covid-19 pandemic, the company through effective use of radio and electronic media, is also spreading the awareness regarding basic eye safety practices to be followed during the pandemic. As COVID-19 pandemic is marching on in India rapidly, Essilor feels there is an urgent need for more collaborative efforts to assist the authorities for providing facilities that can help curb this menace.     ]]> <![CDATA[Glenmark pledges support to tackle COVID-19 outbreak]]> https://biospectrumindia.com/news/95/16287/glenmark-pledges-support-to-tackle-covid-19-outbreak.html https://biospectrumindia.com/news/95/16287/glenmark-pledges-support-to-tackle-covid-19-outbreak.html Wed, 22 Apr 2020 17:55:00 +0530 As millions across the country grapple with the COVID-19 pandemic, Glenmark Foundation, the CSR arm of Glenmark Pharmaceuticals along with its NGO partners, is working closely in alignment with government directives and state health authorities to extend its support - through a combination of on-ground and remote health initiatives. Glenmark Foundation has pledged support in the form of food aid and health services for undernourished children, pregnant and lactating women, migrants, daily wage earners and healthcare providers on the frontlines of the outbreak. A key intervention is the launch of a tele-health solution by the Foundation and its NGO partner Institute for Global Development (IGD), which follows guidelines framed by the governors of the Medical Council of India (MCI) and NITI Aayog. A battery of medical doctors with various specialisations have committed support for the on-call service and have been mobilised to expand access to quality patient care. The services are being rolled out for over 3,00,000 people across the states of Himachal Pradesh, Gujarat and Madhya Pradesh. Commenting on Glenmark’s efforts, Cherylann Pinto, Executive Director, Corporate Services of Glenmark Pharmaceuticals said, “Giving back to the community has always been a Glenmark priority. The COVID-19 pandemic makes it even more imperative for us to support the country’s most vulnerable populations. We are working with the government and our NGO partners across states to extend our support on multiple fronts, to address the needs and challenges during this outbreak.” Glenmark’s efforts across Maharashtra, Gujarat, Himachal Pradesh, Madhya Pradesh, Goa and Sikkim are intended to support the local authorities and work in synergy with the states in the nation’s fight against COVID-19. Amidst the present crisis which has brought on a nationwide lockdown, Glenmark is providing psychological support to 10,000 lactating mothers and pregnant women through telecounselling. Additionally, it is also undertaking vaccination, attending to women undergoing antennal care (ANC), and postnatal care (PNC), and providing health support to children and other patients. The Foundation is also extending support by ensuring adequate monthly supply of food grains to undernourished children, pregnant and lactating women in 70 tribal villages, in Khandwa, Madhya Pradesh and 10 tribal hamlets in Sanjay Gandhi National Park, Mumbai. Apart from these, it has undertaken several initiatives - partnering with local administrations to extend support and feed families of migrant and daily wage workers during the lockdown. Glenmark Foundation is also providing Personal Protective Equipment (PPE) to medical staff in the public health sector in Maharashtra. PPE includes medical masks and gowns, gloves, eye and head protection gear, sanitizers, etc., all of which are critical for health workers. Over 3,500 litres of sanitizers are being distributed across villages, housing societies, police stations and government offices across these states. In acknowledgement of the contribution of law enforcement agencies during this unprecedented time, Glenmark has conducted medical check-ups for 400+ local law enforcement personnel in Ankleshwar, Gujarat. Glenmark Pharmaceuticals has also donated over INR 1.5 crores to various states’ CM Funds and to the PM CARES Fund. In addition, Glenmark will be supplementing to the funds donated generously by its employees for the COVID - 19 relief activities. ]]> <![CDATA[Redcliffe, Sapio work on hyperion plasma treatment for COVID-19]]> https://biospectrumindia.com/news/95/16278/redcliffe-sapio-work-on-hyperion-plasma-treatment-for-covid-19.html https://biospectrumindia.com/news/95/16278/redcliffe-sapio-work-on-hyperion-plasma-treatment-for-covid-19.html Wed, 22 Apr 2020 10:50:00 +0530 A novel treatment invented by a team of scientists from European Medical Association, together with New Delhi based Redcliffe Lifesciences and Mumbai based Sapio Analytics, is proven to cure COVID-19 with higher effectiveness than conventional plasma treatment. "We have innovated an accessible treatment of COVID-19, using the widely accepted concept of plasma treatment, and combining it with adjuvant negative ion therapy using a proprietary ionizer device. The treatment has already been applied in China and Germany (3000+ patients), with successful results, proving to be about 10 times more effective than conventional plasma therapy, with recovery rate of severe and acute patients being less than 48 hours”, informed the innovators of the treatment The group is in the process of seeking approvals from ICMR and other authorities in order to start off clinical trials in India. Dr. Ahmad Abdulaziz AlJaziri from UAE is the lead inventor, with Prof.em.Dr Amina Ather along with Dr.Nayak S.V under the umbrella of EMA as lead research and clinical leader. Redcliffe Lifesciences headed by Dheeraj Jain, Ashish Dubey and Rakesh Maurya is the exclusive commercial and clinical partner, while Sapio Analytics headed by Ashwin Srivastava and Hardik Somani is the government advisory, compliance, and planning partner. Dr Jaziri has previously invented a number of medical devices, including and not limited to, Dr.AlJaziri Mosulator for removing abdominal tumors in a none invasive way, and Clip Applicator patented in Germany in 1990 Prof. Ather has been contributing on non-invasive non drug therapy as an emeritus professor with Peoples republic of china since 2013 . “The treatment and its methodology are driven by data-based results of the said treatment of COVID-19 in UAE, China and Germany and combining the same with data-driven output models of plasma treatment and negative ion therapy, used outside of COVID-19. The methodology is designed and optimized in a manner that it can be administered on a range of patients with varying viral loads, using donors with varying levels of antibodies. This ability to create such a range makes it much more accessible than regular plasma treatment and helps usher India into an era of available COVID-19 treatment. The treatment is also combined with immune modulators of Phyto extracts and anti-influenza drugs”, adds the team about the methodology used in the treatment. Recent reports say that Indian Council of Medical Research (ICMR) has received approvals for clinical trials of plasma treatment in India by the central drug regulator. A list of institutes have received approval for the same. Sapio Umbrella, a brand entity of Sapio Analytics is already engaging with various state governments on a pro- bono basis to assist them with data backed decision support system, for combatting the pandemic. Redcliffe is operating COVID-19 testing labs with partnership with DST’s BSIP and involved in whole genome sequencing of COVID-19 strain apart from distribution of the RT PCR kits. ]]> <![CDATA[DCGI approves Sepsivac trial for COVID-19 treatment]]> https://biospectrumindia.com/news/95/16277/dcgi-approves-sepsivac-trial-for-covid-19-treatment.html https://biospectrumindia.com/news/95/16277/dcgi-approves-sepsivac-trial-for-covid-19-treatment.html Wed, 22 Apr 2020 09:00:00 +0530 The Council of Scientific and Industrial Research (CSIR), through its flagship New Millennium Indian Technology Leadership Initiative (NMITLI) program, has been supporting Cadila Pharmaceuticals Ltd., Ahmedabad since 2007 for developing a drug to save lives of critically ill patients suffering from Gram-negative sepsis. This entire development effort (pre-clinical and clinical studies) has been supervised by CSIR appointed Monitoring Committee. The drug has been shown to reduce the mortality of critically ill patients by more than half. It also leads to faster recovery of organ dysfunction seen in this condition. It is now approved for marketing in India. It will be available commercially as Sepsivac® from Cadila Pharmaceuticals Ltd. This is a moment of pride for all of us as, despite best efforts, no other drug was approved in Gram-negative sepsis for reducing mortality (death) globally. In Gram-negative sepsis as well as in critically ill COVID-19 patients, there is an altered immune response leading to a massive change in their cytokine profile. The drug modulates the immune system of the body and thereby inhibits the cytokine storm leading to reduced mortality and faster recovery. Looking at similarities between clinical characteristics of patients suffering from COVID-19 and Gram-negative sepsis, CSIR, is now initiating a randomized, blinded, two arms, active comparator-controlled clinical trial to evaluate the efficacy of the drug for reducing mortality (deaths) in critically ill COVID-19 patients. The Drugs Controller General of India (DCGI) has approved the trial and it will start soon at multiple hospitals. The drug contains heat-killed Mycobacterium W (Mw). It is found to be extremely safe in patients and no systemic side effects are associated with its use.It can be used concurrently with any other therapies required in the management of such critically ill patients without any restriction. Its unique properties include boosting protective immunity (Th1, TLR2 agonist) and suppressing non-protective response (Th2). CSIR has also planned to evaluate Mw for faster recovery of hospitalized COVID-19 infected patients and minimize the spread of disease through them as well for providing prophylaxis to persons coming in contact with COVID-19 infected patients like family members and health care workers. ]]> <![CDATA[Cipla sets up Rs 25Cr fund to battle COVID-19]]> https://biospectrumindia.com/news/95/16276/cipla-sets-up-rs-25cr-fund-to-battle-covid-19.html https://biospectrumindia.com/news/95/16276/cipla-sets-up-rs-25cr-fund-to-battle-covid-19.html Tue, 21 Apr 2020 16:00:00 +0530 Mumbai based pharma major Cipla has announced an INR 25 crore fund to support the Indian Government’s efforts to effectively combat the COVID-19 pandemic. This includes a voluntary donation of approximately INR 3 crore from Cipla employees who have stepped forward in this hour of national need. Through its wide-ranging relief efforts, the Company is focusing on initiatives that have the maximum impact and reach. It is currently supporting public health institutions, frontline healthcare workers, vulnerable patients and communities struggling in the aftermath. Of the INR 25 crores set aside for COVID response, the Company has announced a donation of INR 9 crore to the PM CARES Fund. In addition, Cipla has announced a donation of INR 8 crore to different State authorities. These contributions will help to further several immediate and long-term relief efforts that the country needs to combat the size and scale of the crisis it is confronted with. Over and above, Cipla Foundation, the social responsibility arm of Cipla, has committed INR 4 crore towards COVID response programmes, many of which are already underway. The Company has also allocated INR 4 crore towards the supply of essentials including medicines, personal protective equipment, sanitisers, masks, gloves and food. Cipla is committed to combatting the crisis on multiple fronts: Caring for patients The company has implemented a spate of stringent safety measures in line with social distancing norms so that manufacturing and distribution of essential medicines can continue despite challenges of remote working. Employees have been working at manufacturing locations and depots, driven to uphold the interest of patients in these difficult times.  Additionally, Cipla has also launched a toll-free helpline to assist its patients in procuring essential medication across therapies from pharmacies and health-care institutions. Through its Foundation, the company has been supporting public health and charitable hospitals to manage the crisis and serve vulnerable patients in need. Since Maharashtra is one of the worst affected, the Foundation has partnered with several hospitals in Mumbai to strengthen the state’s healthcare infrastructure to tackle the pandemic. Towards this, the organization has supported the setting-up of a COVID-19 24/7 testing laboratory at JJ Hospital that will benefit over 4,000 patients as well as the city’s only isolation ward for pediatric patients suspected of having COVID-19 at the BJ Wadia Hospital for Children. The Cipla Palliative Care & Training Centre in Pune continues to offer 24/7 care to patients and families during this challenging time. Caring for the healthcare workforce To safeguard frontline healthcare workers, the Company is supplying essential items like masks, PPE, gloves and sanitizers to over 10,000 doctors, paramedics and associated institutions including tertiary municipal and district hospitals Webinar series are also being organised through industry bodies like the Indian Chest Society, International Diabetes Federation to equip healthcare workers with necessary information on the pandemic. Through its Foundation, the company is aiming to connect doctors and healthcare workers across India with the AIIMS and ICMR led knowledge network on COVID-19 through ECHO India-a technology-based knowledge sharing platform. These online facilities, the first in India for the pandemic, will be set up at leading government and medical colleges. Caring for the community In furtherance of its responsibility to the community, Cipla is providing essential supplies, such as medicines, PPEs, food packets, sanitizers, masks, and gloves to those engaged in essential services like the police and public transport operators as well as individuals living near the Company’s facilities.   ]]> <![CDATA[Zydus explores biologicals route to treat novel coronavirus]]> https://biospectrumindia.com/news/95/16273/zydus-explores-biologicals-route-to-treat-novel-coronavirus.html https://biospectrumindia.com/news/95/16273/zydus-explores-biologicals-route-to-treat-novel-coronavirus.html Tue, 21 Apr 2020 14:00:00 +0530 Zydus Cadila, has announced that its biological therapy Pegylated Interferon alpha-2b, ‘PegiHepTM’ can emerge as one of the pathways to treat COVID 19. The treatment has emerged after the publication of two non-peer reviewed research articles at bioRxiv and medRxiv, the COVID-19 pre-print servers hosted by Cold Spring Harbor Laboratory. The first one by the University of Texas Medical Branch, Galveston, showed an evidence of a direct anti-viral effect of Interferon alpha against novel Coronavirus in vitro. The study demonstrated around 10,000 fold reduction in virus titre in cells that were pre-treated with Interferon alpha 48 hours earlier. The second by a group of universities in China, Australia and Canada retrospectively analysed 77 moderate COVID-19 subjects in Wuhan and observed that those who received Interferon alpha-2b showed a significant reduction in the duration of virus shedding period and even in levels of the inflammatory cytokine, IL-6. This suggests that if a long-acting molecule like Pegylated Interferon alpha is given early on in the infection, the patient suffering from COVID 19 will have a significant benefit as the viral load is reduced, lesser IL-6 is produced and virus eliminating specific immune response is generated. When the human body contracts an infection due to a viral attack, it produces a group of molecules called Type 1 interferons as a first line of defense. Interferon alpha is one such Type 1 Interferon molecule, that not only slows down the viral replication but also helps activate the two arms of our immune system – Innate, for immediate killing of the virus and Adaptive, for long lasting immunity. To make it more effective, the molecule is coupled with polyethylene glycol to produce a new molecule called, Pegylated Interferon alpha, that has the same functionality as Interferon alpha but remains in the body longer and therefore requires only once-a-week injection, thus providing a much better efficacy profile. Interferon alpha-2b has been used in the treatment of COVID-19 in China and Cuba and is a part of treatment guidelines of the Chinese Government. Zydus has been commercially manufacturing Pegylated Interferon alpha-2b under the brand name, PegiHep, since 2011 for the treatment of Hepatitis B and C with 1.5 lac doses being administered. PegiHep is not yet licensed or approved for the treatment of COVID-19. Additionally, Zydus is already manufacturing Hydroxychloroquine which has been found to be effective in treating patients suffering from COVID 19. The group is also working on an accelerated vaccine development programme which is currently in the animal testing stage and if the results are successful it should enter clinical studies in second quarter of this financial year. ]]> <![CDATA[Morepen Labs gets license to manufacture Hydroxychloroquine]]> https://biospectrumindia.com/news/95/16269/morepen-labs-gets-license-to-manufacture-hydroxychloroquine.html https://biospectrumindia.com/news/95/16269/morepen-labs-gets-license-to-manufacture-hydroxychloroquine.html Tue, 21 Apr 2020 11:45:00 +0530 New Delhi based Morepen Laboratories has launched a wide range of essential products being required to combat the growing menace of COVID-19 and to prevent further spread of this disease in the country. These include non-contact Infrared Thermometers, alcohol-based Hand Sanitizers, Hand Wash, Hand Rubs and Face Masks, all under its umbrella brand – Dr. Morepen. The Company has also received license to manufacture Hydroxychloroquine (HCQ) from State Drug Controller (HP) last week for its Baddi plant in Himachal Pradesh and is working towards commercializing the production of HCQ in both API as well as tablets form. HCQ is a prescription based drug commonly being recommended to Corona patients under treatment for the disease. India is taking a lead in supplying HCQ to the rest of the world including USA. India is the largest producer of HCQ and will continue to retain its leadership position in this time of crisis. Speaking on the development, Sushil Suri, Chairman and Managing Director, Morepen Laboratories Ltd., said, “The Contagion is spreading fast in every nook and corner of our country. As a result, we are working round the clock to maintain regular supply of all essential items and medical supplies required in the process even during these difficult times. We stand firmly with the Govt. of India and customers with all the vigor and commitment to help fight COVID-19.” ‘Non-Contact Infrared Thermometers’ measure temperature by Infrared rays from a distance without any physical contact with the person whose temperature is to be measured. These thermometers swiftly measure temperature from a distance of 1cm-5cm from the forehead of a person entering any public place like a hotel, airport, factory, office or any religious place. These are widely being used across the world to detect potential Corona carriers. These are battery-operated, handy and easy to use thermometers, which do not require any trained technicians. The company has also expanded its range of ‘Alcohol based Sanitizers’, ‘Hand Wash’, ‘Hand Rubs’ and ‘Face Masks’ under the brand ‘Dr. Morepen Protect’. The company is manufacturing sanitizers as per Govt. of India approved formula with 70% isopropyl alcohol and has also introduced a product with 83% ethyl alcohol (WHO formula). Further, ‘Hand Sanitizers’ and ‘Hand Rub’ produced by the company also contain moisturizers like Aloe Vera, which helps in preventing hands dryness if applied multiple times in a day. The wide variety of Dr. Morepen hand sanitizers catering to cross section of consumers like individuals, commercial establishments, hospitals and government bodies are being supplied in various pack sizes ranging from 100ml., 200 ml., 500 ml., 1000 ml. and bulk packs of 5 Liters. Company has ramped up its production base and supplied more than 2 million units of its hand sanitizers already. Dr. Morepen Face mask (2-ply and 3-ply) are being offered in a pack of five (5) and fifty (50) masks according to the market need. All the aforesaid products are being supplied to both private and government bodies involved in combat of Coronavirus. ]]> <![CDATA[Takeda India pledges to stand united for Hemophilia ]]> https://biospectrumindia.com/news/95/16257/takeda-india-pledges-to-stand-united-for-hemophilia-.html https://biospectrumindia.com/news/95/16257/takeda-india-pledges-to-stand-united-for-hemophilia-.html Fri, 17 Apr 2020 17:00:00 +0530 On World Hemophilia Day, Takeda India, part of Takeda Pharmaceutical Company Limited has announced that it pledges to stand united to support patients for a better life and brighter future.  Takeda says that it is committed to driving awareness and conversations around Hemophilia to ensure an increased number of diagnoses and, thus, timely treatment with quality replacement therapy.   Koki Sato, General Manager, Takeda India, commented, "As a company, we are committed to serving patients suffering from Hemophilia and support them in their journey to ensure an improved quality of life. Together with the hematology community, we are raising expectations for the future, including earlier diagnosis, earlier and full protection against bleeds, and more personalized patient care. With our innovative therapies, awareness drives, and initiatives, we aim to contribute towards building a bleed free India by 2030." Through Access to Medicine (AtM) strategy, Takeda aims to address the broader structural barriers that prevent patients in underserved communities from receiving the care and treatment they deserve. In addition to AtM, Takeda India in 2017, launched Purna Samparq, a patient support program to address the critical unmet needs of Hemophilic patients by offering them Counselling, Diagnostic, Physiotherapy, Nursing and Education Support under the guidance of the Consulting Physician to improve the quality of life. Gopal Agrawal, Head Market Access, Patient Advocacy, and Patient Services, Takeda India, said “We are committed to addressing the unmet needs of patients wherever they may be, and sustainably strengthening local health systems at every stage of the patient journey. We complement this approach with a commitment towards developing an end-to-end access approach to make our highly-innovative medicines available as soon as practically possible”. Hemophilia is an inherited single gene disorder that is usually inherited, and about one in every 5,000 males is born with the disorder. As per a reputed patient body in the country, there are approximately 21,000 registered hemophilia patients in India. This rare disease mostly impacts pediatric males. While most of the patients opt for on-demand treatment when an episode of bleed occurs, there is prophylaxis treatment that can reduce the annual bleed rate, therefore leading to a reduced lifetime risk of future bleeds and helping the patients to live a better-quality life.  ]]> <![CDATA[P&G India to donate face masks and hand sanitizers in response to COVID-19]]> https://biospectrumindia.com/news/95/16248/pg-india-to-donate-face-masks-and-hand-sanitizers-in-response-to-covid-19.html https://biospectrumindia.com/news/95/16248/pg-india-to-donate-face-masks-and-hand-sanitizers-in-response-to-covid-19.html Thu, 16 Apr 2020 18:30:00 +0530 Procter & Gamble India, has stepped up its efforts to serve the country in response to COVID-19 under its response program ‘P&G Suraksha India’. The company has announced that it will produce face masks and hand sanitizers for its employees, and to support the government and relief organizations who are on the front lines of this pandemic in India. The production of hand sanitizers has begun in Roorkee, and the company has manufactured the first batch already. The company will soon begin manufacturing 3-ply face masks in Hyderabad. Madhusudan Gopalan, MD & CEO, P&G Indian Subcontinent, said, “Under our program ‘P&G Suraksha India’ we are stepping up to support the government and those who are on the front line in India’s fight against COVID-19. We have started production of hand sanitizers and we will begin the production of masks soon, using it to ensure our people can continue operating safely and sharing it with those who are on the front line. To start with, we will donate 1.5 million masks to government and relief organizations to combat the spread of this pandemic. The face masks and hand sanitizers that we will make will also help us protect the health and safety of P&G people and to ensure that P&G can continue to serve Indian consumers with cleaning, health and hygiene products during this time when they are needed the most.” Madhusudan further added, “The P&G people remain committed to manufacture and make our critically important cleaning, health and personal hygiene available to serve the people of India during these unprecedented times. We are making these products available following the highest safety and health standards and advice from government and medical authorities. We will continue to step up as a ‘Force for Good’ and leverage our innovation, manufacturing and marketing expertise to support our communities during this time of need.” Under its response and relief program ‘P&G Suraksha India’, P&G has also undertaken the following initiatives to serve the communities during this challenging time: We are extending our support to the broader community through in-kind, product and critical supplies to aid frontline and essential workers who are tirelessly working to combat the spread of COVID-19 We are leveraging our advertising and brand voice on traditional and social media responsibly and our in-store and direct-to-consumer capability, to increase awareness on safety and hygiene measures among consumers and our community We are playing a pivotal role in partnership with government to leverage best in class P&G Capabilities to raise the Health & Hygiene standards in retail stores and manufacturing units across the country P&G employees in India are donating to the ‘PM Cares Fund’ to support India’s fight against COVID-19   ]]> <![CDATA[Emami launches anti-germ hand sanitizer]]> https://biospectrumindia.com/news/95/16247/emami-launches-anti-germ-hand-sanitizer.html https://biospectrumindia.com/news/95/16247/emami-launches-anti-germ-hand-sanitizer.html Thu, 16 Apr 2020 18:15:00 +0530 As demand for hand sanitizers reaches a new peak amidst the recent spread of the world pandemic of COVID 19, Emami Limited, manufacturer of personal care & beauty products forays into the hand sanitizer space under its flagship skincare brand BoroPlus by launching the BoroPlus Advanced Anti-Germ Hand Sanitizer. Emami has prioritised the launch of this Hand Sanitizer – an essential commodity in the midst of the Covid-19 epidemic, ensuring the maximum available production capacity in order to bring an effective product to consumers in the shortest possible time, given the dire need for the same. Speaking on the launch, Priti A. Sureka, Director, Emami Limited, said, “We are today going through a critical time and our foremost thought is to protect not only our own selves but also our families, friends and people around.   It is essential for us to inculcate & adhere to the increased hygiene guidelines as advised in view of the spread of COVID 19.  Hand Sanitizers have a key role and are an integral component in this fight against virus infection as stated by the WHO and various clinical establishments.   There is a huge gap in the demand & supply of hand sanitizers in the market, which puts all of us at risk.  We have, therefore, decided to launch the BoroPlus Hand Sanitizer from the house of Emami Limited. BoroPlus is well known for its antiseptic benefits, being the No.1 Antiseptic Cream brand in the country, and the launch of a hand sanitizer is a natural extension of the BoroPlus brand promise. We will leverage our strong distribution network as well as modern trade and e-commerce channels to make the product easily available.” The BoroPlus Advanced Anti-Germ Hand Sanitizer has an alcohol base of 70%. ]]> <![CDATA[Indira IVF adapts IoT technique in its embryology labs]]> https://biospectrumindia.com/news/95/16234/indira-ivf-adapts-iot-technique-in-its-embryology-labs.html https://biospectrumindia.com/news/95/16234/indira-ivf-adapts-iot-technique-in-its-embryology-labs.html Wed, 15 Apr 2020 17:25:00 +0530 Indira IVF, a fertility chain in India, uses Internet of Things (IoT) technique in their embryology labs. With the help of IoT, sophisticated sensors and chips are embedded in equipments which monitors and records the valuable data and also transmits in real time. IoT systems are based on web, application or cloud and also represent data graphically for real time monitoring. With this IoT technology, clinics can understand better how their system and equipment’s are working. Indira IVF was the first player to install lab care quality control systems in India by installing the Labcare system in its Udaipur centre. And as of today, 42 main centres of Indira IVF are equipped with Labcare system. In the process, IVF labs creates embryos which requires artificial womb and also factors like temperature, CO2, pH, humidity, etc. in lab as embryos are very susceptible to even minute changes in these conditions. With the help of IOT platform, it provides labs with accurate data, dual check point, data accessibility from anywhere and intelligent alarm systems. The alarm system send notification via email, automated calls, SMS etc. to concerned person and in case of no response it can also be escalated to senior management. The data collected by an automated system with actual insights without any human bias helps in minimizing errors. This technology allows us to access and monitor data by sitting at home helping us to keep an eye on quality control 24/7 X 365 days. Indira IVF is using two systems currently regarding IoT platform, firstly IVF Labcare system which take care of different specializations like lab care, lab health, Cyro sense, cold sense, freeze sense etc and secondly RI Witness system which ensure patient’s confidence about the safety of gametes and tracks length of procedures , exposure of samples out of incubators and person handling the samples. Speaking about IoT technique, Dr. Nitiz Murdia, Director Embryology, Indira IVF, said, “By using IoT, Indira IVF aims to provide quality care and quality treatment to the patients. For a large group like Indira IVF IoT adds versatility in its quality control and it not only also helps lab team to reduce its workload in a busy setup but also brings security and peace of mind to IVF patients. We aim to reproduce future in present by embracing technology for benefit of not only patients or our organization but for society.” Speaking about the same, Naval Shah, Head Embryology Quality Assurance, Indira IVF, stated, “IoT is a powerful tool which helps to analyze varied data of the entire group under one umbrella. This helps in monitoring lab and culture conditions that are very critical to human embryo growth and helps to produce excellent results. It optimizes efficiency of both lab and lab personals leading to Excellency.” Apart from Indira IVF, RI witness system is presently installed only in 4 other centers of India. With regards to electronic witnessing system the RI witness system was first incorporated in to Indira IVF in November 2019. Since then this has been installed actively in 20 out of 42 centers and have the target to install them in all the main centers by May, 2020. ]]> <![CDATA[Biocon and Mylan launch Fulphila]]> https://biospectrumindia.com/news/95/16228/biocon-and-mylan-launch-fulphila.html https://biospectrumindia.com/news/95/16228/biocon-and-mylan-launch-fulphila.html Wed, 15 Apr 2020 14:05:00 +0530 Biocon and Mylan has announced the launch of Fulphila®, a biosimilar to Neulasta® (pegfilgrastim) in Australia. Fulphila is approved by the Therapeutic Goods Administration for the treatment of cancer patients following chemotherapy, to decrease the duration of severe neutropenia and so reduce the incidence of infections, as manifested by febrile neutropenia. Fulphila is now available on the Pharmaceutical Benefits Scheme (PBS). The approval of Fulphila was based on a comprehensive package of analytical, nonclinical and clinical data, which confirmed that the product is highly similar to Neulasta and no clinically meaningful differences in terms of safety and efficacy exist. Dr Christiane Hamacher, CEO, Biocon Biologics said, “We are extremely pleased to enable access to our high quality, affordable biosimilar pegfilgrastim for patients in Australia. Fulphila, co-developed by Biocon Biologics and Mylan, is the third biosimilar to be commercialized in Australia and we hope that continued penetration of our biosimilars will enable higher cost savings for the Australian healthcare system. We are committed to use our science, scale and expertise to shift the access paradigm for patients in need of biosimilars like pegfilgrastim across the globe.” Mylan Australia Country Manager, Sylvain Vigneault, commented, “Mylan is proud to launch Fulphila, the third biosimilar to be offered through the Mylan-Biocon Biologics partnership in Australia, as part of its commitment to expand access to more affordable medicines. Biosimilars ensure patients have timely and affordable access to quality, safe and effective treatments in a way that is sustainable for the Pharmaceutical Benefits Scheme. Globally, Mylan is a leader in biosimilars with one of the largest and most diverse biosimilars portfolios which includes 20 biosimilar and insulin analog products in development or on the market. We’re pleased to continue to bring this experience and expertise to patients in Australia.” A suite of patient services will be available at launch to further support patients and caregivers with treatment. Fulphila, co-developed by Biocon Biologics and Mylan, was the first biosimilar pegfilgrastim to be approved in the U.S. and was successfully launched in July 2018, thus expanding access for patients in need of an affordable alternative. Fulphila has received regulatory approval in more than 30 countries around the world. More affordable treatment options such as biosimilars for healthcare providers and their patients enable savings for healthcare systems around the world, including the PBS in Australia. The Australian government recognises the importance of driving biosimilar uptake to create a competitive and sustainable biosimilars market. In 2015, they committed to the Biosimilar Awareness Initiative and in 2018 they increased their commitment by supporting the Generic and Biosimilar Medicines Association through a $5 million grant to undertake not only increased education around biosimilars in general, but also activities that further promote the appropriate prescribing, dispensing and use of biosimilar medicines. Biocon Biologics’ scientific expertise and world-class R&D and manufacturing facilities have enabled it to bring multiple biosimilar therapeutics to the US and Europe. It has a product pipeline of 28 molecules, including 11 with Mylan, several with Sandoz, and is developing many independently. The Company’s therapeutic basket includes molecules from diabetes, oncology, immunology, dermatology, ophthalmology, neurology, rheumatology and inflammatory diseases. Mylan and Biocon Biologics are exclusive partners on a broad portfolio of biosimilar and insulin products. Our biosimilar pegfilgrastim is one of the 11 biologic products being co-developed by Mylan and Biocon for the global marketplace. Mylan has exclusive commercialization rights for the product in the U.S., Canada, Japan, Australia, New Zealand and in the European Union and European Free Trade Association countries. Biocon has co-exclusive commercialization rights with Mylan for the product in the rest of the world.   ]]> <![CDATA[Mapmygenome launches Genomepatri Immunity ]]> https://biospectrumindia.com/news/95/16221/mapmygenome-launches-genomepatri-immunity-.html https://biospectrumindia.com/news/95/16221/mapmygenome-launches-genomepatri-immunity-.html Wed, 15 Apr 2020 09:10:00 +0530 Hyderabad based Mapmygenome announces the launch of a new product Genomepatri™ Immunity. It contains genetic risk factors for an array of immune system diseases along with some lifestyle diseases like diabetes, heart disease and other comorbidities that affect overall health status and immune function and thus, the severity of symptoms/infection.  The report also includes a person’s genetic response to a variety of drugs including antivirals and antifungals, and levels of various vitamins and minerals.  Anu Acharya, Mapmygenome CEO said, “The Genomepatri Immunity report is a result of extensive hours of hard work put in by our expert team. While this is not a diagnostic test, we see its tremendous potential in prevention and improving patient outcomes. A good immune response is a key in defeating COVID-19.  Genomepatri Immunity is intended to enable us to strengthen ourselves and fight COVID-19 and other diseases better.  The report also covers how we respond to drugs that may be used during treatment and that will be very useful to treating physicians.” Genetic factors related to immunity play a very important role in SARS-CoV pathogenesis and many genes have been tested for their association with infection. Inter-individual variation in coronavirus susceptibility may be caused by polymorphisms (small variations) in genes. Carriers of certain genetic variants are more likely to suffer from severe coronavirus infection. This report helps individuals in self-isolation watch out for the earliest presenting symptoms if exposed to the virus. Medical professionals can identify patients at risk for cytokine storms and use the pharmacogenomics information to devise personalised treatment plans. Mapmygenome’s current Genomepatri customers have already received a free COVID-19 Immunity and Risk panel report.  This report contains SARS-CoV susceptibility and severity (cytokine storm) and predicts genetic predisposition to immunity associated disease risk factors, nutrition elements such as Zinc and Vitamin levels as well as response to medications such as Chloroquine and Abacavir.   ]]> <![CDATA[Sanofi, GSK to develop adjuvanted COVID-19 vaccine ]]> https://biospectrumindia.com/news/95/16224/sanofi-gsk-to-develop-adjuvanted-covid-19-vaccine-.html https://biospectrumindia.com/news/95/16224/sanofi-gsk-to-develop-adjuvanted-covid-19-vaccine-.html Wed, 15 Apr 2020 08:00:00 +0530 Sanofi and GSK have announced that they have signed a letter of intent to develop an adjuvanted vaccine for COVID-19, using innovative technology from both companies, to help address the ongoing pandemic. Sanofi will contribute its S-protein COVID-19 antigen, which is based on recombinant DNA technology. This technology has produced an exact genetic match to proteins found on the surface of the virus, and the DNA sequence encoding this antigen has been combined into the DNA of the baculovirus expression platform, the basis of Sanofi’s licensed recombinant influenza product in the US. GSK will contribute its proven pandemic adjuvant technology. The use of an adjuvant can be of particular importance in a pandemic situation since it may reduce the amount of vaccine protein required per dose, allowing more vaccine doses to be produced and therefore contributing to protect more people.  The companies have set up a Joint Task Force, co-chaired by David Loew, Global Head of Vaccines, Sanofi and Roger Connor, President Vaccines, GSK. The taskforce will seek to mobilize resources from both companies to look for every opportunity to accelerate the development of the candidate vaccine. ]]> <![CDATA[Lasa’s Progesterone API receives FDA nod ]]> https://biospectrumindia.com/news/95/16222/lasas-progesterone-api-receives-fda-nod-.html https://biospectrumindia.com/news/95/16222/lasas-progesterone-api-receives-fda-nod-.html Tue, 14 Apr 2020 13:40:00 +0530 API major, Lasa Supergenerics Ltd has forayed into the hormone and steroid API segment for Human application with its approval from the Food and Drug Administration authorities to manufacture Progesterone, a steroid hormone, at its WHO GMP certified facility at Mahad Industrial Area. Commenting on the development, Dr Omkar Herlekar, Chairman, Lasa Supergenerics Limited, said “The trial batches have already been carried out and we are in good stead to start manufacturing from the current month itself. This foray may lead us to expanding the existing facilities to add capacities and capabilities to manufacture other hormonal drugs too” Additionally mentions “The progestin hormone is naturally occurring to women but growing demand for this drug comes due to increasing occurrences of infections to the likes of amenorrhea, uterine tumor, breast cancer and lifestyle caused issues such as infertility, absence of menstrual periods besides its use in contraceptive pills. The market for this drug has been anticipated to grow at a 14% CAGR and is dominated by the North American markets followed by Asia Pacific and Europe” Anticipating a shortage in domestic requirements, Progesterone is 1 of the 26 drugs that had a restriction for exports due to the COVID 19 situation due to India’s import dependencies on Chinese Suppliers. Though the ban was lifted by the DGFT on April 6, except for paracetamol, it seems in the times to come there is going to be a huge demand supply gap to be addressed in the times to come. The Hubei province of China caters to more than 2/3 of the $400 mn hormone and steroid API market which has a huge demand even in ROW countries. Progesterone is almost a 250 MT annual market spread over demand of over several Indian formulators including pharma mnc's. Currently local demand is catered mostly by imports from china. Other than domestic business, export potential is almost to the tune of 150 MT in ROW countries which anticipates the total market of progesterone at approximately $80 mn. Lasa had earlier announced its collaboration with ICT to work on the Favipiravir molecule considering it as a promising antiviral to treat the deadly COVID 19 virus due to its RNA capabilities against many viruses such as influenza and Ebola. Its efforts are underway, it currently seeks necessary permissions from DCGI for conducting bioequivalence clinical trials in India to showcase its effectiveness and get into full scale production with the support of the government or strategic investments or tie-ups.   ]]> <![CDATA[Lasa receives FDA nod for Progesterone API]]> https://biospectrumindia.com/news/95/16216/lasa-receives-fda-nod-for-progesterone-api.html https://biospectrumindia.com/news/95/16216/lasa-receives-fda-nod-for-progesterone-api.html Tue, 14 Apr 2020 12:00:00 +0530 API major, Lasa Supergenerics Ltd has forayed into the hormone and steroid API segment for Human application with its approval from the Food and Drug Administration authorities to manufacture Progesterone, a steroid hormone, at its WHO GMP certified facility at Mahad Industrial Area. Commenting on the development, Dr Omkar Herlekar, Chairman, Lasa Supergenerics Limited, said “The trial batches have already been carried out and we are in good stead to start manufacturing from the current month itself. This foray may lead us to expanding the existing facilities to add capacities and capabilities to manufacture other hormonal drugs too” Additionally mentions “The progestin hormone is naturally occurring to women but growing demand for this drug comes due to increasing occurrences of infections to the likes of amenorrhea, uterine tumor, breast cancer and lifestyle caused issues such as infertility, absence of menstrual periods besides its use in contraceptive pills. The market for this drug has been anticipated to grow at a 14% CAGR and is dominated by the North American markets followed by Asia Pacific and Europe” Anticipating a shortage in domestic requirements, Progesterone is 1 of the 26 drugs that had a restriction for exports due to the COVID 19 situation due to India’s import dependencies on Chinese Suppliers. Though the ban was lifted by the DGFT on April 6, except for paracetamol, it seems in the times to come there is going to be a huge demand supply gap to be addressed in the times to come. The Hubei province of China caters to more than 2/3 of the $400 mn hormone and steroid API market which has a huge demand even in ROW countries. Progesterone is almost a 250 MT annual market spread over demand of over several Indian formulators including pharma mnc's. Currently local demand is catered mostly by imports from china. Other than domestic business, export potential is almost to the tune of 150 MT in ROW countries which anticipates the total market of progesterone at approximately $80 mn. Lasa had earlier announced its collaboration with ICT to work on the Favipiravir molecule considering it as a promising antiviral to treat the deadly COVID 19 virus due to its RNA capabilities against many viruses such as influenza and Ebola. Its efforts are underway, it currently seeks necessary permissions from DCGI for conducting bioequivalence clinical trials in India to showcase its effectiveness and get into full scale production with the support of the government or strategic investments or tie-ups. ]]> <![CDATA[Dr Reddy's launches Leukemia drug in India]]> https://biospectrumindia.com/news/95/16214/dr-reddys-launches-leukemia-drug-in-india.html https://biospectrumindia.com/news/95/16214/dr-reddys-launches-leukemia-drug-in-india.html Tue, 14 Apr 2020 05:00:00 +0530 Dr. Reddy’s Laboratories Ltd., has announced the launch of Invista®, a formulation of Dasatinib that is bioequivalent to the innovator brand. It is indicated for the treatment of chronic accelerated or myeloid or lymphoid blast phase and newly diagnosed in chronic phase adult patients with Chronic Myeloid Leukemia (CML) in India. Commenting on the launch, M V Ramana, Chief Executive Officer, Branded Markets (India and Emerging Markets), Dr. Reddy’s Laboratories said, “We are pleased to bring this important and complex product to the market in India. The development and launch of Invista® is a significant step forward in improving access to medicines at an affordable price for CML patients in India. Dr. Reddy’s Invista® is available in strengths of 50, 70 and 100 mg tablets. Chronic Myeloid Leukemia is a type of blood-cell cancer that begins in the bone marrow. The median age of the patients in India is a decade earlier than the west, and every year about nine thousand new patients are diagnosed in the country. ]]> <![CDATA[Sesderma launches Lactyferrin to counter COVID-19]]> https://biospectrumindia.com/news/95/16187/sesderma-launches-lactyferrin-to-counter-covid-19.html https://biospectrumindia.com/news/95/16187/sesderma-launches-lactyferrin-to-counter-covid-19.html Mon, 13 Apr 2020 08:25:00 +0530 Sesderma, a Spanish company specializes in Nanotechnology, has managed to produce an effective drug named Lactyferrin (LF) to counter the COVID-19 strain. Lactyferrin (LF) is known to exhibit medicinal properties and strengthen the immune system. Since the COVID-19 strain targets immuno-compromised people, LF can turn out to be a very potent medicine against the disease. Antiviral activity is associated with the effect of acting as a competitor of cell membrane receptors commonly used by viruses to enter cells. Specifically, lactoferrin is an ACE2 blocker and prevents the binding of the protein S from the virus spike to the host cell, preventing the virus from being fused to the cell membrane. The nanoliposome also has a beneficial action related to its size and composition (phosphatidyl choline). Because of its smaller size (100 nm) than the virus (150 nm), the liposome competes in to reach the target cell more quickly, where it settles before the virus. Lactyferrin can also suppress replication of the virus after the virus enters the cell as in the case of AIDS (Puddu et al, 1998). Also, since the liposome that encases the Lactyferrin is made of soy lecithin (phosphatidyl choline), the medicine is biodegradable and biocompatible, which it means it is very safe. Dr. Gabriel Serrano Sanmiguel, CEO and Founder of Sesderma Laboratories said, “More than 75 patients affected by COVID-19 have been successfully treated to date with moderate to severe clinical features. Seeing the effectiveness of the medicine, the Madrid local authority has asked for the use of Lactyferrin as well. It has been also proven by us that from certain doses Lactyferrin is able to prevent COVID-19 infection. In addition, we have contributed to the success of compassionate treatments with Lactyferrin in at least 4 intubated hospitalized patients with high-risk and virtually evicted analytical signs.” “The sheer scale on which this catastrophe has encompassed the world has brought us to a point where we desperately need a cure for this disease and looking at the test results and patient response, I believe Lactyferrin can help shift the tide in our favour,” he further added. Treatment with Lactyferrin has already begun in Madrid at the Isema Hospital. The medicine will be tested on 300 patients at different hospitals in Madrid and Valencia. Seeing the overwhelming success of the medicine against the COVID-19 strain, Sesderma has initiated an official contract with the health authority of Valencian community. Recently, Sesderma contacted Dr Harsh Vardhan, Health Minister of India about the effectiveness of Lactyferrin against COVID-19, and how it has been successful in completely curing 75 patients. He directed Sesderma to share this solution with the Indian Council of Medical Research (ICMR). Sesderma has approached ICMR to conduct its own trial to verify the effectiveness Lactyferrin. Company has volunteered to support ICMR with 30 to 40 patients. Large scale production of LF is already under way, and once it gets its green flag from the ICMR, we finally might have an effective solution to end the pandemic.         ]]> <![CDATA[Excelra releases COVID-19 drug repurposing database ]]> https://biospectrumindia.com/news/95/16204/excelra-releases-covid-19-drug-repurposing-database-.html https://biospectrumindia.com/news/95/16204/excelra-releases-covid-19-drug-repurposing-database-.html Mon, 13 Apr 2020 06:30:00 +0530 Hyderabad based Excelra, a leading global data and analytics company today announced the release  of the COVID-19 Drug Repurposing Database (https://www.excelra.com/covid-19-drug-repurposing-database/). The ‘open-access’ database presents a compilation of ‘previously approved’ small molecules and biologics with known preclinical, pharmacokinetic, pharmacodynamic, and toxicity profiles that can rapidly enter either Phase 2 or 3 clinical trials on fast track basis for COVID-19.  In addition, the database also includes information on promising drug candidates that are in various ‘clinical, pre-clinical and experimental’ stages of drug discovery and development for COVID-19. Alluding to this wealth of information, Dr. Nandu Gattu, Senior Vice President, Pharma Analytics, Excelra said, “The COVID-19 DR database is a compilation of crucial data that is dispersed across numerous publications, reports, databases and knowledge-repositories along with referenced literature covering the drug, disease, target, and mechanism of action. Our endeavour is in support to the ongoing global scientific efforts for identifying safe and effective therapeutic options to treat the novel coronavirus disease.” Drug Repurposing at Excelra is powered by their Global Repurposing Integrated Platform (GRIP) that combines proprietary repurposing databases, algorithms, analytics tools and a visualization engine. The GRIP database is built by amassing vast chemical data, biological data and clinical data which together contribute to more than 10 million associations among ‘drug-disease-target’ triads. ]]> <![CDATA[Medikabazaar launches COVID Combat Collaborative Platform]]> https://biospectrumindia.com/news/95/16195/medikabazaar-launches-covid-combat-collaborative-platform.html https://biospectrumindia.com/news/95/16195/medikabazaar-launches-covid-combat-collaborative-platform.html Fri, 10 Apr 2020 00:00:00 +0530 In a bid to defeat coronavirus from further spreading its wings, Medikabazaar has instituted a COVID Combat Collaborative Platform on its website. The single platform connects COVID buyers, COVID sellers and COVID experts to facilitate timely and sufficient supply of medical essentials, vital for life-saving or preventive healthcare purposes against the pandemic. The step is aimed at eliminating misinformation regarding the demand-supply of essential medical goods, at all ends. The medtech company has established a single-point platform on their website to facilitate smooth communication regarding the supplies of medical equipment and commodities, amidst the mandated lockdown. The initiative directly connects sellers and buyers of the medical goods pertaining to coronavirus such as ventilators, hand-sanitizers, thermometers, personal protection equipment kit, 3 ply masks, goggles, and more. The efforts are made by the company to collaborate with the customers & suppliers to help supply hospitals, health centres, quarantine centres, pharmacies and other screening and medical facilities across the private and public sectors. Interested buyers/sellers can join the network through their website https://www.medikabazaar.com/. The easy-to-use interface of the platform displays the products available at the seller’s end and allows the buyer to order them directly in the desired quantity by filling in a simple form. Medikabazaar's COVID Collaboration Platform Team contacts the user within 24 hours to assist on the subject and provide active solutions. Speaking about the initiative, Mr. Vivek Tiwari, Founder and CEO, Medikabazaar, said, “Through COVID combat Collaboration Platform, we are looking to collaborate with all suppliers, healthcare institutions and industry experts to come together and help each other fight the deadly virus. The idea is to reduce confusion over demand and supply of COVID medical supplies in such crucial times, wherein any misinformation can be detrimental to human life.”   ]]> <![CDATA[Cipla receives approval for Albuterol Sulfate Inhalation Aerosol ]]> https://biospectrumindia.com/news/95/16181/cipla-receives-approval-for-albuterol-sulfate-inhalation-aerosol-.html https://biospectrumindia.com/news/95/16181/cipla-receives-approval-for-albuterol-sulfate-inhalation-aerosol-.html Thu, 09 Apr 2020 18:40:00 +0530 Cipla has announced the final approval for its Abbreviated New Drug Application (ANDA) for Albuterol Sulfate Inhalation Aerosol 90mcg (base)/actuation, from the United States Food and Drug Administration. It is the first AB-rated generic therapeutic equivalent version of Merck Sharp & Dohme Corp’s Proventil HFA Inhalation Aerosol and is used for treatment of acute episodes of bronchospasm or prevention of asthmatic symptoms. Umang Vohra, MD and Global CEO, Cipla Limited said, “We are pleased to receive the final approval for generic Albuterol MDI from the USFDA. This further strengthens our presence in the US market. Albuterol is the first generic metered dose inhaler of Proventil HFA Inhalation Aerosol ever approved by FDA in the US and Cipla’s first device-based inhalation product in the market. This development reiterates our commitment of strengthening our respiratory franchise and will further solidify our position as lung leader globally. We will continue to build on our portfolio of drug-device combinations in the respiratory space to serve the unmet needs of our patients across markets.” According to IQVIA (IMS Health), Proventil HFA Inhalation Aerosol and its authorized generic equivalent had US sales of approximately $153M for the 12-month period ending February 2020. The entire Albuterol Sulfate HFA Inhalation Aerosol market had US sales of approximately $2.8 Billion for the 12-month period ending February 2020.       ]]> <![CDATA[DCGI approves Roche’s Atezolizumab for breast cancer treatment ]]> https://biospectrumindia.com/news/95/16164/dcgi-approves-roches-atezolizumab-for-breast-cancer-treatment-.html https://biospectrumindia.com/news/95/16164/dcgi-approves-roches-atezolizumab-for-breast-cancer-treatment-.html Thu, 09 Apr 2020 05:05:00 +0530 Roche India has announced the launch of Atezolizumab for the treatment of metastatic triple-negative breast cancer (TNBC) in India. Atezolizumab (cancer immunotherapy drug) in combination with nab-Paclitaxel (Chemotherapy) can now be used as a first-line treatment for TNBC patients. This approval from the Drug Controller General of India (DCGI) is based on the data from phase III IMpassion130 study according to which Atezolizumab is proven to significantly reduce the risk of disease worsening or death (PFS) in the intention-to-treat and PD-L1 positive population with metastatic or unresectable locally advanced triple-negative breast cancer (TNBC). Additionally, it has shown an encouraging overall survival (OS) in the PD-L1 positive population at this interim analysis. V. Simpson Emmanuel, General Manager, Roche Products (India) Pvt. Ltd said, “Atezolizumab is the first immunotherapy drug to be approved globally and in India for triple negative breast cancer, an aggressive disease with very limited treatment options. Roche has been at the forefront of improving the lives of patients diagnosed with breast cancer. This launch further strengthens our commitment to provide better outcomes for patients with unresectable locally advanced and metastatic triple-negative breast cancer in India.” Breast cancer is the most common cancer amongst women across the world impacting 2.1 million women each year. According to Globocan 2018, over 160,000 new cases of breast cancer were in India. TNBC is a rare type of breast cancer that experiences rapid progression and it is defined by the lack of expression and/or amplification of the targetable receptors for oestrogen, progesterone and HER2 amplification. Triple negative breast cancer represents 31% of all breast cancers and is more common in women under the age of 50, compared with other forms of breast cancer. Atezolizumab in combination with nab-paclitaxel, is indicated for the treatment of patients with unresectable locally advanced or metastatic TNBC- whose tumors have PD-L1 expression ≥1%, and who have not received prior chemotherapy for metastatic disease. Previously, Atezolizumab has been approved either alone or in combination with targeted therapies and/or chemotherapies in various forms of Non-Small cell Lung Cancer (NSCLC) and Small Cell Lung Cancer(ES-SCLC) and for certain types of untreated or  previously treated metastatic Urothelial Carcinoma (mUC) with improved survival outcomes, comparable safety profile and improved quality of life.  Roche has been developing medicines with the goal to redefine treatment in oncology and investing more in bringing innovative treatment options that help a person’s own immune system fight cancer.   ]]> <![CDATA[IPA releases document on employee safety]]> https://biospectrumindia.com/news/95/16162/ipa-releases-document-on-employee-safety.html https://biospectrumindia.com/news/95/16162/ipa-releases-document-on-employee-safety.html Wed, 08 Apr 2020 12:00:00 +0530 India and the world today are going through unprecedented times on account of COVID 19 pandemic. During these trying times, supply of medicines is fundamental need of the hour for which smooth functioning of manufacturing operations is critical.  Recognizing this, the Government of India also categorized pharmaceutical manufacturing, distribution, ancillary and support operations as essential goods and services and exempted it from lockdown. Employee safety is vital for keeping the manufacturing operations open during this pandemic.  IPA and its members' companies have come together to develop the ‘Best Practices’ document to safeguard employee safety in pharmaceutical manufacturing. The document echoes general insights on preventative measures and provides a comprehensive set of best practices for the safety of employees engaged in manufacturing and covers:  Effective communication across manufacturing network Employee segregation and remote working for non- essential work force On-site personnel and material movement norms Workplace infrastructure & mechanisms to avoid contamination Mitigation measures for employees contacting COVID-19 Engaging local authorities and healthcare providers   Satish Reddy, President, Indian Pharmaceutical Alliance, acknowledged the role of pharma manufacturing operations and appreciating its employees’ efforts in ensuring the supply of medicines, and said, “Employees in the pharmaceutical manufacturing sector play a crucial role as they continue to work to produce and ensure uninterrupted supply of medicines to patients in these challenging times.” Sudarshan Jain, Secretary-General, Indian Pharmaceutical Alliance said, “These are unprecedented times. Employee Safety has and always been fundamental and our top priority. This document demonstrates our commitment to provide employees safe and healthy working environment.” IPA reaffirms its commitment to ensure sustained access to high quality medicines in the country and across the world. IPA acknowledges the relentless efforts by the employees in the pharma manufacturing industry. ]]> <![CDATA[CSIR-NCL identifies drug intermediates & KSMs from essential medicines list]]> https://biospectrumindia.com/news/95/16158/csir-ncl-identifies-drug-intermediates-ksms-from-essential-medicines-list.html https://biospectrumindia.com/news/95/16158/csir-ncl-identifies-drug-intermediates-ksms-from-essential-medicines-list.html Wed, 08 Apr 2020 11:50:00 +0530 CSIR-NCL has identified 8-10 drug intermediates and KSMs from the essential medicines list for strategic reasons posed by the COVID-19 crisis and possible shortage of raw materials. Continuous flow synthesis with minimal or no solvent use, process optimization and reaction engineering, the areas in which CSIR-NCL has prior experience and expertise, will bring down the production cost. NCL has recently developed environment friendly reactive distillation process for paracetamol from acetic acid as the acylating agent. NCL flow chemistry group has ready platform technologies for continuous nitration, halogenation, diazotization, ozonolysis, oxidation reactions which are routinely used in pharmaceuticals synthesis. In addition to cost economics, minimal chemicals, process safety, and environment friendly, the biggest advantage of multi-step continuous flow technology is that the production can be carried out on smaller scale in a distributed model at several locations, a factor which will be important in the medical emergency situation facing the country. Various KSMs of important drug intermediates identified by CSIR-NCL are: 2-Methyl-5-nitroimidazole (MNI) for the nidazole category of antibiotic and antiprotozoal medications such as Tinidazole, Metronidazole, Ornidazole, etc. Guanine for acyclovir (anti-viral) and as a basic heterocycle skeleton in drug molecules 1,1-Cyclohexane-diacetic acid (CDA) for gabapentin (neuropathic). India imports 15,000 tons of CDA annually Dicyandiamide (2-Cyanoguanidine) as basic raw material for metformin (largest selling anti-diabetic drug) as a bulk raw material for melamine. DCDA import is 21,000 tons per annum (TPA) and domestic production is presently nil Para-amino phenol (PAP) for the production of analgesic paracetamol. PAP imports is 30,000 TPA and domestic production is nil Salicylic acid used in the manufacture aspirin, and requirement is 25,000 TPA Fluorinated and chlorinated benzoic acids used in fluoroquinolone antibiotics, ciprofloxacin, olfloxacin, levofloxacin, etc. to treat serious bacterial infections, including skin, bone and joint, lower respiratory tract and urinary tract infections Newly announced drugs towards repurposing for the treatment of Covid-19 infections such as hydroxyl-chloroquine, Ritonavir-Lopinavir combination, and other anti-viral drugs will be designed using the optimal synthetic route and flow chemistry process for industry. Apart from chemical synthesis routes to abovementioned drugs and pharmaceuticals, several essential and important drugs such as penicillins, cephalosporins, tetracycline and streptomycin drugs class, as well as steroids and vitamins are manufactured using microbial and fermentation-based routes using microbes and enzymatic catalysis. Penicillin-G (Pen-G), 6-amino-penicillanic acid (6-APA) and 7-amino-cephalosporonic acid (7-ACA) building block chemicals together add up to about 15,000 tons of imports into India. Toward Penicillin intermediate production CSIR-NCL is working on a basic research program for discovery of indigenous biological strains and cultures to synthesize Pen intermediates. Out of 300 strains, a high throughput screen is set up to identify the high production cultures, which will be genetically modified to meet the requirements for commercialization. In a bottom up approach, metabolic engineering and synthetic biology methods are directed to build optimal microbial and biochemical routes for important pharmaceutical intermediates. The major challenges in this approach are to achieve higher titter for the product yield per fermentation batch in short reaction times and recycle of the enzymes and microbial strains. India’s drug manufacturing generic pharma industry has been predominantly relying on chemical synthesis and continuous process routes to production. CSIR-NCL R&D roadmap aims at enabling the industry to accelerate domestic production using innovative and economical processes under the Government scheme for distributed pharma hubs in the country.   ]]> <![CDATA[Merck gets second U.S. Patent for CRISPR Gene-Editing Technology]]> https://biospectrumindia.com/news/95/16157/merck-gets-second-u-s-patent-for-crispr-gene-editing-technology.html https://biospectrumindia.com/news/95/16157/merck-gets-second-u-s-patent-for-crispr-gene-editing-technology.html Wed, 08 Apr 2020 11:40:00 +0530 Merck, a leading science and technology company has announced that the United States Patent and Trademark Office has granted the company’s patent for CRISPR-chrom technology. With this allowance, Merck is the only provider with a patent covering the fusion of chromatin modulating peptides to CRISPR proteins, helping to clear chromatin out of the way, increasing access to the genome. Udit Batra, member of the Merck Executive Board and CEO, Life Science said, “This award marks our second U.S. CRISPR patent and our 23rd CRISPR-related patent worldwide, and as a leading innovator of CRISPR technology, we will continue to drive innovation and collaborate with scientists around the world to ensure that they have the most advanced gene-editing options.” Because genomic DNA in mammalian cells is wrapped tightly in protein complexes called chromatin, the genomic DNA is often inaccessible to CRISPR. Merck’s CRISPR-chrom technology works by fusing chromatin modulating peptides to a CRISPR protein, Cas9 (i.e., CRISPR’s DNA scissors), allowing for more efficient gene editing. The Life Science business of Merck, a leader in genome editing, conducts research and development to drive improvements in gene-editing technologies. The company’s CRISPR patent portfolio includes granted patents for CRISPR-related technologies covering foundational and alternative genome-editing methods. Patents for the company’s CRISPR integration technology have been granted in Australia, Canada, China, Europe, Israel, Singapore and South Korea. Patents granted in Europe and pending elsewhere cover plasmid or viral vectors encoding CRISPR systems, which are necessary to perform genome modification in eukaryotic cells. Other European patents and pending applications are for protein-RNA nickase compositions. Merck received its first U.S. patent in February 2019 for its proxy-CRISPR technology, which makes CRISPR more efficient, flexible and specific. The company has successfully out-licensed its CRISPR patent portfolio and continues to license its entire CRISPR patent portfolio for all fields of use.   ]]> <![CDATA[IIL to lead research collaboration for COVID-19 vaccine]]> https://biospectrumindia.com/news/95/16150/iil-to-lead-research-collaboration-for-covid-19-vaccine.html https://biospectrumindia.com/news/95/16150/iil-to-lead-research-collaboration-for-covid-19-vaccine.html Wed, 08 Apr 2020 08:00:00 +0530 Indian Immunologicals Limited (IIL), a leading vaccines manufacturing company, has announced that the company is going to commence research for developing a vaccine for Corona Virus (COVID-19), the pandemic which has infected more than a million and killed about 55,000 people across the world so far. The Hyderabad, India, headquartered vaccine maker joined hands with Griffith University of Australia by entering into an agreement for research collaboration to conduct exploratory research to develop a lead vaccine candidate for Coronavirus. In this significant cross-continental collaboration, scientists from Indian Immunologicals Limited and Griffith University (Australia) will develop a ‘Live Attenuated SARS – CoV-2 vaccine’ or Covid-19 vaccine using the latest codon de-optimization technology.  The technology looks promising for developing a vaccine for prophylactic, active, single dose immunization against coronavirus in humans, with an enhanced safety profile. The vaccine is expected to provide long-lasting protection with a single dose administration with an anticipated safety profile similar to other licensed vaccines for active immunization. Upon completion of the research, the vaccine strain will be transferred to Indian Immunologicals Limited and the vaccine maker will work accordingly with the country’s regulator – CDSCO (The Central Drugs Standard Control Organisation) - to further conduct clinical trials which will be taken up in a phased manner. IIL intends to use its existing Vero cell platform technology for mass production of the virus. Speaking on the development, Dr K Anand Kumar, Managing Director, Indian Immunologicals Limited said, “IIL is committed to addressing critical public health needs by engaging in this research collaboration. The mission at IIL is to develop and supply vaccines that support the One Health initiative. IIL has taken up this initiative to develop a vaccine candidate for the pandemic – COVID-19. IIL’s leadership in producing safe and affordable human and veterinary vaccines will enable us to progress well in this endeavor”. Commenting on the research collaboration, Dr Prasanna Deshpande, Dy. Managing Director, Indian Immunologicals Limited said, “After evaluating various options being followed across the world, we decided to develop a Live Attenuated Covid-19 vaccine based on codon de-optimization technology.  With our dedicated research and development capabilities supported with excellent team of scientists and engineers, IIL is committed to developing high-quality vaccines that are affordable. We are confident that this new cross-continental collaboration will yield the desired results”. “We are very excited to be able to work closely with Indian Immunological Limited for development of this important vaccine to solve this urgent public health crisis. Our live-attenuated vaccine will be developed using codon de-optimization technology and is expected to provide long lasting immunity against SARS – CoV-2 following a single immunisation and cross-protection against other coronaviruses (e.g. MERS, SARS-CoV-1). As this vaccine will be a live attenuated vaccine it is expected to be highly effective by providing very strong cellular and antibody immune responses against the virus. The other benefit of a live-attenuated vaccine is a proven track record for economical large-scale manufacturing and well-known regulatory approval pathway.” said Professor Suresh Mahalingam, Menzies Health Institute Queensland, Griffith University, Australia on the research collaboration. Indian Immunologicals Limited is already working with Griffith University, Australia for conducting research and development of Zika virus vaccine which is currently at pre-clinical toxicology testing stage. The joint project has been progressing well and Indian Immunologicals Limited is expected to submit the application for conducting clinical trials in due course. The codon de-optimization technology has been successfully employed to reduce the virulence of several RNA viruses including Enterovirus C (Poliovirus), Human Immunodeficiency virus type 1, Zika virus etc. ]]> <![CDATA[Stempeutics partners with Global Consortium of cell therapy companies]]> https://biospectrumindia.com/news/95/16153/stempeutics-partners-with-global-consortium-of-cell-therapy-companies.html https://biospectrumindia.com/news/95/16153/stempeutics-partners-with-global-consortium-of-cell-therapy-companies.html Wed, 08 Apr 2020 05:05:00 +0530 Bengaluru based Stempeutics Research, a group company of Manipal Education and Medical Group (MEMG), announced that it has partnered with Global Consortium of cell therapy companies seeking European Commission Funding to Fight Against Corona! (FAC!). Under this partnership, Stempeutics will export its stem cell product Stempeucel® (subject to regulatory approvals) for treating critically ill COVID-19 patients with lung disease. First the product will be clinically tested and upon successful outcomes, it intends to export the product on a regular basis. In this connection it is signing up an alliance with Educell Ltd, Slovenia. Stempeucel® is an allogeneic, off the shelf, pooled mesenchymal stromal cells having antiinflammatory and immune-modulatory properties which prevents the over activation of the immune system. Stempeucel® product exhibits a wide range of potent therapeutic properties. The product exhibits potent immunomodulatory and anti-inflammatory properties which could help in reducing the inflammation caused due to the cytokine storm elicited by the body’s immune cells in response to SARS-CoV-2 (COVID-19) related infection in the lungs. Also, the growth factor, Angiopoietin-1 (Ang-1) is effective in reducing alveolar epithelium permeability in the lung. Hence it is envisaged, Stempeucel® will reduce the fatal symptoms of COVID 19 induced pneumonia and its progression to ARDS. BN Manohar, CEO of Stempeutics said, “From the clinical data using Stempeucel® in different clinical trialsin other indications it may be postulated that Stempeucel® has the potential capability for treating COVID 19 infection. Together with the safety profile observed from DCGI approved clinical trials involving more than 350 patients injected with Stempeucel® by different routes of injection, this therapy may help in mitigating the lung tissue damaging effects of COVID 19 infection”. ]]> <![CDATA[Premas Biotech, Akers Bio announce progress of COVID-19 vaccine development]]> https://biospectrumindia.com/news/95/16151/premas-biotech-akers-bio-announce-progress-of-covid-19-vaccine-development.html https://biospectrumindia.com/news/95/16151/premas-biotech-akers-bio-announce-progress-of-covid-19-vaccine-development.html Tue, 07 Apr 2020 20:00:00 +0530 US based Akers Biosciences, Inc., a developer of rapid health information technologies, has announced that its collaboration with Gurugram based Premas Biotech has successfully completed the milestone of obtaining clones of all three coronavirus antigens, Spike (S), Envelope (E), and Membrane (M) that they have selected for their vaccine candidate. The clone development process has four primary steps including first, the design and synthesis of the genes; second, the selection of the right host; third, the insertion of the gene into the host; and fourth, the verification that the clone has the right gene, and all characteristics are correct. Prabuddha Kundu, Co-Founder and Managing Director at Premas Biotech, commented, “We are pleased with the successful completion of this phase in the development of our novel vaccine candidate. We believe that our ability to clone all three of these antigens will differentiate our vaccine candidate from others. Specifically, the surface of a virus is what the immune systems sees, and importantly has a multitude of proteins. We are providing the immune system with three shots on goal, instead of one, by including S, E, and M together. This is increasingly important due to the likelihood of protein mutation. If a protein mutates, a vaccine can be rendered non efficacious, a scenario often faced with seasonal flu variations. By including three at one time, the immune system can still recognize the other two antigens, which we believe will enhance its efficacy and assist us in making this vaccine candidate successful.” Christopher Schreiber, Executive Chairman of Akers, stated, “We believe that we are one step closer to an effective vaccine candidate for the coronavirus pandemic. We have now completed our first important milestone by generating these clones. We also have initiated the second stage in protein expression, which we hope to provide an update on later this month. We are optimistic about the continued success of our partnership with Premas, one that is already starting to bear fruit.” ]]> <![CDATA[TUV Rheinland offers free tests for ventilators]]> https://biospectrumindia.com/news/95/16130/tuv-rheinland-offers-free-tests-for-ventilators.html https://biospectrumindia.com/news/95/16130/tuv-rheinland-offers-free-tests-for-ventilators.html Tue, 07 Apr 2020 05:25:00 +0530 The dramatic spread of COVID-19 has disrupted lives, livelihoods, communities, and businesses worldwide. Organizations around the world are coming together and finding innovative ways to minimize the impact on public health and to limit disruptions to economies and supply chains. Keeping the current COVID-19 pandemic in mind, TUV Rheinland India has stepped up its humanitarian efforts by offering 'No Cost' Safety Critical type tests on Ventilator Systems which are produced in India at its Bangalore laboratory till 30th April 2020. TUV Rheinland's state-of-the-art laboratory is capable of testing a wide range of medical device categories, as per national and international standards. The laboratory has been recognized nationally and internationally for testing and certification by the National Accreditation Board for Testing and Calibration Laboratories (NABL) and International Commission on Rules for the Approval of Electrical Equipment (IECEE), for CB certification of medical devices. TUV Rheinland is offering free test services for Ventilator Systems according to IEC 60601-1, IEC 60601-1-2, and IEC 80601-2-12. Over 25 different types of tests were identified to ensure basic safety and part compliance with all applicable standards and requirements. Ventilators are one of the most important machines hospitals have for keeping COVID-19 critical care patients alive. Health authorities around the world are trying to find ways to supply hospitals with adequate number of ventilators to cope with the increasing number of Covid-19 patients. Commenting on the initiative, Thomas Fuhrmann, Managing Director, TUV Rheinland India said, "It is the responsibility of each one of us to play a role in lessening the damaging impact of the virus and TUV Rheinland would like to play our part in the fight against COVID- 19. This is our initiative to support vulnerable members of our society as well as healthcare professionals and all those who are at the forefront of this pandemic." He added, "We are offering free testing services to ensure uninterrupted, safe medical devices in the market.  TUV Rheinland India has in-house capability to test and evaluate medical devices for electrical safety, EMC, wireless and reliability parameters according to various national and international standards." ]]> <![CDATA[Bharat Biotech to develop one drop COVID-19 nasal vaccine]]> https://biospectrumindia.com/news/95/16119/bharat-biotech-to-develop-one-drop-covid-19-nasal-vaccine.html https://biospectrumindia.com/news/95/16119/bharat-biotech-to-develop-one-drop-covid-19-nasal-vaccine.html Fri, 03 Apr 2020 12:00:00 +0530 Bharat Biotech has announced that a unique intranasal vaccine for Coronavirus ‘CoroFlu’ is under development. An international collaboration of virologists at the University of Wisconsin–Madison and the vaccine companies FluGen along with Bharat Biotech has begun the development and testing of a unique vaccine against COVID-19 called CoroFlu. CoroFlu will build on the backbone of FluGen's flu vaccine candidate known as M2SR. Based on an invention by UW–Madison virologists and FluGen co-founders Yoshihiro Kawaoka and Gabriele Neumann, M2SR is a self-limiting version of the influenza virus that induces an immune response against the flu. Kawaoka’s lab will insert gene sequences from SARS-CoV-2, the novel coronavirus that causes the disease COVID-19, into M2SR so that the new vaccine will also induce immunity against the coronavirus. Sharing details about ‘CoroFlu’ far-reaching collaboration Dr.Raches Ella, Head of Business Development, Bharat Biotech said, “Bharat Biotech will manufacture the vaccine, conduct clinical trials, and prepare to produce almost 300 million doses of vaccine for global distribution.  Under the collaboration agreement, FluGen will transfer its existing manufacturing processes to Bharat Biotech to enable the company to scale up production and produce the vaccine for clinical trials. Raches added, Bharat Biotech has commercialized 16 vaccines, including a vaccine developed against the H1N1 flu that caused the 2009 pandemic.” Refinement of the CoroFlu vaccine concept and testing in laboratory animal models at UW–Madison is expected to take three to six months. Bharat Biotech in Hyderabad, India will then begin production scale-up for safety and efficacy testing in humans. CoroFlu could be in human clinical trials by the fall of 2020. Four Phase I and Phase II clinical trials involving hundreds of subjects have shown the M2SR flu vaccine to be safe and well tolerated. This safety profile, M2SR’s ability to induce a strong immune response, and the ability of influenza viruses to carry sequences of other viruses make M2SR an attractive option for rapidly developing CoroFlu as a safe and effective SARS-CoV-2 vaccine. “We are going to modify M2SR by adding part of the coding region for the coronavirus spike protein that the virus uses to latch onto cells and begin infection,” says Gabriele Neumann, a senior virologist in Kawaoka’s lab and co-founder of FluGen. “CoroFlu will also express the influenza virus hemagglutinin protein, which is the major influenza virus antigen, so we should get immune responses to both coronavirus and influenza.” M2SR is a unique form of the flu virus. It lacks a gene called M2, which restricts the virus to undergoing only a single round of replication in cells. “The single replication means the virus can enter the cell, but it can’t leave,” says FluGen co-founder, president and CEO Paul Radspinner. “So, in essence it tricks the body into thinking it’s infected with flu, which triggers a full immune response. But since it can’t replicate further, you don’t get sick.” CoroFlu, like M2SR, will be delivered intranasally. This route of administration mimics the natural route of infection by coronavirus and influenza and activates several modes of the immune system. Intranasal delivery is more effective at inducing multiple types of immune responses than the intramuscular shots that deliver most flu vaccines. The Kawaoka group will insert genetic sequences from SARS-CoV-2 into M2SR and then assess CoroFlu’s safety and efficacy in animal models at UW–Madison’s Influenza Research Institute. The institute has a high-level biosafety facility designated Biosafety Level 3 Agriculture with the ability to safely handle and study pathogens like highly pathogenic influenza viruses and the novel coronavirus. M2SR was developed by FluGen and includes technology exclusively licensed through the Wisconsin Alumni Research Foundation (WARF), which manages patents for UW–Madison. “To confront a global challenge, this is collaborative discovery at its best,” says Erik Iverson, CEO of WARF.  “The partners in this endeavor — University of Wisconsin researchers, a biotech startup, and an international vaccine developer — are moving forward with a sense of urgency and integrity incumbent upon us as scientists and world citizens.” “The core mission of Bharat Biotech is to apply innovative technologies in addressing the healthcare concerns of the developing world and to provide them with affordable, high quality vaccines and therapeutics,” Raches Ella, expressed. “Ninety percent of our vaccines are sold in lower middle-income countries with affordable pricing being core to our business model. We will fervently work toward the successful development of an efficacious COVID-19 vaccine.”  THE BIG DIFFERENTIATOR OF ‘COROFLU’ Mucosal immunity (derived in the lining of the nose and respiratory tract) is very critical for respiratory illness. CoroFlu is based on the influenza vaccine and will provide immunity to the H2N2 strain of seasonal influenza. Bharat Biotech is confident CoroFlu will be the most effective in the prevention of COVID-19. Today, infectious diseases not only kill people, but hurt the economy of the country, says Dr. Raches Ella.  Of Late, we have more seasonal flu problems in the country which is also getting into pandemic as recent evidence indicates in Delhi, Hyderabad, and other cities. We are attempting to solve both the problems together with a new approach for the first time in the world. ]]> <![CDATA[Transasia’s latest manufacturing facility receives ISO certification]]> https://biospectrumindia.com/news/95/16106/transasias-latest-manufacturing-facility-receives-iso-certification.html https://biospectrumindia.com/news/95/16106/transasias-latest-manufacturing-facility-receives-iso-certification.html Thu, 02 Apr 2020 13:10:00 +0530 Transasia Bio-Medical Ltd’s recently inaugurated state-of-the-art manufacturing unit at SEEPZ has been certified by ISO and ICMED. The facility and processes were subjected to a stringent evaluation by the UL LLC India, a global safety certification company. Post assessment, we have received the certificate for ISO 9001:2015 and ISO 13485: 2016 and have been deemed compliant for design, development, manufacture, installation and service of our entire range of IVD analyzers and reagents at this facility as well. All our other manufacturing facilities at Mumbai, Daman, Baddi and Sikkim are already ISO and ICMED certified and have been employing GMP and rigorous quality standards and meeting the requisites laid down by ISO and ICMED.We are now aiming to boost our annual production capacity by 50% and facilitate manufacturing of new products that are in the pipeline and are likely to be launched in the near future. In these trying times, while the focus is on increasing testing capacities, we would once again like to assure our doctors, healthcare professionals and patients, the Transasia-Erba group continues its legacy of offering the highest quality analyzers and reagents to ensureaccuracy and precision for timely diagnosis. ]]> <![CDATA[Clensta International launches instant hand hygiene solution]]> https://biospectrumindia.com/news/95/16100/clensta-international-launches-instant-hand-hygiene-solution.html https://biospectrumindia.com/news/95/16100/clensta-international-launches-instant-hand-hygiene-solution.html Thu, 02 Apr 2020 00:00:00 +0530 Clensta International, a leading biotechnology company has announced the launch of Clensta Instant Hand Hygiene Solution; an advance formula for hand sanitization. The novel product offers instant 99.9% germ protection with antimicrobial and antiseptic properties that will establish the new product as a quick solution for all-round protection and freshness. The move augments the company’s personal hygiene portfolio, which currently has Instant Body Sanitation - Comprehensive Antiseptic Body Hygiene Solution (Waterless Body Bath) and Instant Head Hygiene - Comprehensive Head Hygiene Solution (Waterless Shampoo) in the market. The launch comes in the wake of the Covid-19 pandemic. This waterless product is in line with Clensta’s commitment to providing sustainable hygiene solutions which do not use water thereby encouraging water conservation. Dr. Puneet Gupta, CEO Clensta International said, “We are excited to introduce an all-new category in waterless hygiene segment in India with the launch of Clensta Instant Hand Hygiene Solution; an advance formula for hand sanitizer. Clensta, over the years, has been a driver of change to help and protect our loved ones by providing instant hygiene to anyone, anywhere and anytime, hence we conducted research to understand the new cleanliness regime and mindset. Interestingly, the findings reveal that 70% of mothers believe cleaning is equivalent to germfree. This waterless hand rub is an ideal offering to ensure cleanliness and underscores our commitment to maintaining a germ-free environment." Clensta Instant Hand Hygiene Solution is enriched with the integration of active portent and extracts that kills 99.9% germs without the use of water and disinfects hands.  A skin-friendly hand hygiene solution is effective against germs, bacteria and viruses to protect hands in regular routine use. The product is easy to use by applying directly on your palm, back of hands, fingertips, nail grooves for 30 seconds to cover the sides thoroughly and rub until dry. Clensta’s latest product is an easy, one-stop solution which can be used to protect from 100 illness-causing germs.  The company further stressed the need to educate people about proper hygiene. What appears to be visibly clean is not necessarily germ- free and that there is a need to practise cleanliness in day to day activities. Thus, waterless innovation will be a novel solution to ensuring cleanliness. Clensta International holds recognition by Hon’ble President of India and was also selected among the best five start-ups for a presentation to Hon’ble Prime Minister of India. The company also holds a National award for contribution to healthcare. ]]> <![CDATA[Cipla completes Phase-3 trails for generic version of GSK’s Advair Diskus]]> https://biospectrumindia.com/news/95/16102/cipla-completes-phase-3-trails-for-generic-version-of-gsks-advair-diskus.html https://biospectrumindia.com/news/95/16102/cipla-completes-phase-3-trails-for-generic-version-of-gsks-advair-diskus.html Thu, 02 Apr 2020 00:00:00 +0530 Cipla Limited has announced the successful completion of Phase-3 clinical end-point study for fluticasone propionate and salmeterol inhalation powder (100/50 mcg). Fluticasone propionate and salmeterol inhalation powder 100/50 mcg, 250/50 mcg and 500/50 mcg are generic versions of GSK’s Advair Diskus®. The product is indicated to treat asthma in patients 4 years and older as a twice-daily prescription medicine and in long term to treat chronic obstructive pulmonary disease (COPD), including chronic bronchitis, emphysema, or both, for better breathing and fewer flare-ups. The Phase-3 study, successfully completed in the first attempt, was conducted over a period of 15 months at over 100 sites in the US enrolling 1400 asthma patients. The study results demonstrate that Cipla’s fluticasone propionate and salmeterol inhalation powder 100/50 mcg is therapeutically equivalent to Advair Diskus® 100/50mcg. The study demonstrated therapeutic equivalence by assessing the primary end points which is in accordance with regulatory recommendations and guidelines. There were no safety concerns identified during the trials. Commenting on the trial completion, Umang Vohra (MD and Global CEO, Cipla, Limited) said “I am extremely pleased with the successful completion of the Phase-3 clinical study of generic Advair Diskus®. Considering the complexity of clinical endpoint study in the Fluticasone + Salmeterol combination, it is heartening to see that our study was successful in the first attempt. This is an important milestone and is a testament to Cipla’s strong respiratory capabilities and will go a long way in strengthening our respiratory franchise in the US. Unmatched presence across the care continuum and the widest range of drug-device combinations has established Cipla’s position as a lung leader in India and other key emerging markets. Our endeavour is to extend this expertise across developed markets through niche product development.”  According to IQVIA (IMS Health), Advair Diskus® and its generic equivalents had US sales of approximately US$2.9bn for the 12-month period ending February 2020. ]]> <![CDATA[NovaLead identifies 42 approved drugs to potentially treat COVID-19]]> https://biospectrumindia.com/news/95/16067/novalead-identifies-42-approved-drugs-to-potentially-treat-covid-19.html https://biospectrumindia.com/news/95/16067/novalead-identifies-42-approved-drugs-to-potentially-treat-covid-19.html Tue, 31 Mar 2020 09:05:00 +0530 NovaLead Pharma, the Pune based pioneer in the field of drug repurposing in India, has deployed its proprietary computational technology for identifying existing drugs which may be potentially effective against the SARS-Cov2 virus as well as for minimizing its impact on human body. Through a complex and extensive computational study involving 2010 approved drugs and 30 potential viral and human targets, NovaLead has identified 42 existing drugs which may be helpful to patients at different stages of SARS-Cov-2 infection. The CEO of NovaLead Pharma, Mr. Supreet Deshpande said - “Use of existing drugs already approved by the regulators can offer a huge relief in the short to medium term, if found effective against Covid 19. The major advantage with this approach is that the drugs being approved are already proved to be safe for humans, are being actively manufactured and therefore can be immediately put to use in a very short time. If successful, the Physicians can save lives and also prevent early infections from turning critical. The fight against Covid19 is a race against time and we are deploying whole of our computational infrastructure and technology platform armed with Artificial Intelligence (AI) and uses Machine Learning (ML) techniques, along with intensive statistical modeling and simulations.” Novalead’s technology has an established track record of successfully discovering repurposed drug candidates with its lead drug candidate, Galnobax® currently being in Phase 3 trial in India, for diabetic foot ulcers, a global unmet medical need. The second repurposed candidate identified by NovaLead, NLP91 is for the treatment of psoriasis which will get in clinical trial in 2021. Informing about status of their research, NovaLead Pharma’s head of research, Dr. Sudhir Kulkarni said – “Novalead is pursuing a multi-pronged strategy involving multiple scientific computational approaches. We have completed three phases of rational computational screenings and our discoveries so far include drugs that show promise as effective treatment either by directly attacking the virus proteins or by empowering the human proteins to minimize it’s spread. Our research effort shall continue to further shortlist candidates for specific stages of infection by SARS-Cov-2 virus including those reaching the Acute respiratory distress syndrome (ARDS) stage.” ]]> <![CDATA[CSIR-NCL makes R&D roadmap for indigenous drug intermediates]]> https://biospectrumindia.com/news/95/16073/csir-ncl-makes-rd-roadmap-for-indigenous-drug-intermediates.html https://biospectrumindia.com/news/95/16073/csir-ncl-makes-rd-roadmap-for-indigenous-drug-intermediates.html Tue, 31 Mar 2020 09:05:00 +0530 The Union Cabinet headed by Prime Minister Narendra Modi approved on 21 March a special package for the Promotion of Bulk Drugs Parks to finance common infrastructural facilities and production-linked incentive schemes for the manufacture of key starting materials (KSMs)/ drug intermediates and active pharmaceutical ingredients (APIs) in the country, in response to the medical emergency situation which might arise due to COVID-19 lockdown for extended period. A list of 53 APIs / bulk drugs was identified, half of them are based on chemical synthesis on which Pune based CSIR-National Chemical Laboratory (CSIR-NCL) is focusing. The Indian pharmaceutical industry is the third largest by volume but it is critically dependent on imports of raw materials or KSMs, in some cases to over 80% extent, mainly from China. Drug security, self-sufficiency and continuous supply of essential medicines are the need of the hour for national security and healthy population. India has the largest number of FDA approved manufacturing sites outside of USA.  The more than 27 or so bulk drugs covering different therapeutic classes such as anti-viral, retro-viral, antibiotics, anti-bacterial, anti-fungal, cardiovascular, diabetes, cholesterol lowering, anti-cancer to simple pain killer like paracetamol, are synthesized from about 10-12 simpler building blocks or KSMs/ drug intermediates. Self-sufficiency in drug supply chain for India means indigenous processes and platform technology to produce these important KSMs. In consultation with industry experts and from the list of essential APIs, the Organic Chemistry and Chemical Engineering scientists of CSIR-National Chemical Laboratory analysed the structures of chemical intermediates and the state of readiness employing synthetic routes which are scaleable and economical. For 3-4 drug intermediates/ bulk chemicals, R&D projects are already ongoing and these will be fast tracked. For remaining 4-5 molecules, the most efficient routes considering atom economy, novel catalysis, flow chemistry, process intensification, plant safety, cost of raw materials, reagents and solvents, and recycling of by-products, and energy management have been designed. These chemical processes will bring down the cost of production through continuous flow synthesis, process optimization and reaction engineering, an area in which CSIR-NCL has prior experience and expertise. CSIR-NCL scientists have reported a novel and economical chemical synthesis of cystic fibrosis drug Ivacaftor in 2018, which is one of the highest priced drugs for patients (US $300 000 per year per patient). CSIR-NCL has recently demonstrated flow synthesis with minimal or no solvent use which will make significant economic benefit when translated for the identified molecules. Apart from cost economics, minimal chemicals, process safety, and environment friendly, the biggest advantage of multi-step continuous flow technology is that the production can be carried out on smaller scale in a distributed model at several locations, a factor which will be important in the medical emergency situation facing the country. Director Prof. Ashwini Kumar Nangia is hopeful that CSIR-NCL will be able to release the R&D reports to Govt. and chemicals and pharmaceutical industry bodies soon as each laboratory scale process is ready in the next few weeks and months to be taken up for manufacturing by Indian drug companies. The capability and infrastructure for further synthesis of final APIs from the intermediate KSMs largely exists in the country.    ]]> <![CDATA[Lupin’s Inhalation Research Center receives EIR from USFDA ]]> https://biospectrumindia.com/news/95/16060/lupins-inhalation-research-center-receives-eir-from-usfda-.html https://biospectrumindia.com/news/95/16060/lupins-inhalation-research-center-receives-eir-from-usfda-.html Mon, 30 Mar 2020 11:40:00 +0530 Lupin has announced the receipt of the Establishment Inspection Report (EIR) from the USFDA for its Inhalation Research Center located at Coral Springs, Florida. The facility was inspected by the USFDA, between February 19, 2020 and February 26, 2020, on behalf of the U.K. MHRA for Lupin’s generic Fostair application to the U.K. MHRA. Commenting on the receipt of the EIR, Vinita Gupta, CEO, Lupin said, “The Inhalation Research Center at Florida was established to develop quality respiratory products to benefit patients across the U.S. and other advanced markets. The receipt of the EIR with satisfactory VAI status validates our commitment towards ensuring the highest levels of quality and CGMP compliance at all our sites. We are grateful for the U.S. FDA’s confidence in our team during this critical juncture in the fight against COVID-19, when it has become imperative that we focus on bringing high quality respiratory products to market.” Lupin’s Inhalation Research Center at Coral Springs, Florida, inaugurated in August 2015, focuses on research and development of respiratory products for the treatment of asthma, chronic obstructive pulmonary diseases and other respiratory ailments.   ]]> <![CDATA[Sun Pharma to donate Rs 250 M of medicines, hand sanitizers]]> https://biospectrumindia.com/news/95/16051/sun-pharma-to-donate-rs-250-m-of-medicines-hand-sanitizers.html https://biospectrumindia.com/news/95/16051/sun-pharma-to-donate-rs-250-m-of-medicines-hand-sanitizers.html Mon, 30 Mar 2020 08:55:00 +0530 Sun Pharmaceutical Industries Ltd. has announced its commitment to donate Rs 250 Million (Indian Rupees Two Hundred and Fifty Million) of Hydroxychloroquine (HCQS), Azithromycin, other related drugs and hand sanitizers to support India’s COVID-19 pandemic response. Sun Pharma urges people both in India and around the world not to hoard medicines, in order to make sure they are available to those in genuine need. The company is committed to working closely with the governments and relevant stakeholders to ensure there is uninterrupted supply of medicines. Sun Pharma is constituting a task force to handle the distribution of these products in India. ]]> <![CDATA[Lupin, Mylan announce positive EMA opinion of Biosimilar Etanercept]]> https://biospectrumindia.com/news/95/16057/lupin-mylan-announce-positive-ema-opinion-of-biosimilar-etanercept.html https://biospectrumindia.com/news/95/16057/lupin-mylan-announce-positive-ema-opinion-of-biosimilar-etanercept.html Sun, 29 Mar 2020 00:00:00 +0530 Lupin Limited and Mylan ave announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the approval of Nepexto®, a biosimilar to Enbrel® (etanercept), for all indications of the reference product including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, axial spondyloarthritis (including ankylosing spondylitis and non-radiographic axial spondyloarthritis), plaque psoriasis and paediatric plaque psoriasis. The positive CHMP opinion is based on a biosimilarity assessment which included preclinical and clinical studies demonstrating bioequivalence to the reference product. In addition, a phase 3 clinical study in patients with moderate-to-severe active rheumatoid arthritis confirmed equivalence of Nepexto to the reference product in terms of efficacy, safety and immunogenicity.  The CHMP positive opinion will now be considered by the European Commission (EC). Once approved, the EC will grant a centralized marketing authorization for member countries of the EU. The decision on the EC’s approval is expected in May 2020. Vinita Gupta, CEO, Lupin Limited said, “Biosimilars like Nepexto will play a critical role in expanding access to patients in Europe, providing an effective treatment for multiple therapies including rheumatoid arthritis. We are extremely pleased with the positive CHMP opinion on our application. This milestone brings us one step closer to bringing an affordable biosimilar to etanercept to the European market through our partner Mylan. Once approved by the European Commission, Nepexto will be our first biosimilar to receive regulatory approval in Europe. Building on this progress, we continue to focus on advancing our biosimilar pipeline.” Mylan President, Rajiv Malik commented, “We are pleased with the positive CHMP opinion for Nepexto, biosimilar etanercept. This recommendation validates the strong scientific program supporting this important treatment, which is one of 20 biosimilar products in our broad and diverse biosimilars portfolio, and our shared commitment with Lupin to help increase access to more affordable biologics treatments, such as etanercept, in Europe and many other regions around the world.” Enbrel had sales of approximately US$ 9.6 billion globally for the 12 months ending December 2019, according to IQVIA. In June 2018, Lupin and Mylan announced a collaboration to commercialize a biosimilar to etanercept in several global markets. ]]> <![CDATA[mCaffeine partners with Clinikk]]> https://biospectrumindia.com/news/95/16058/mcaffeine-partnerswith-clinikk.html https://biospectrumindia.com/news/95/16058/mcaffeine-partnerswith-clinikk.html Sun, 29 Mar 2020 00:00:00 +0530 mCaffeine, India’s fastest growing caffeine infused personal care brand has partnered with Clinikk, the healthcare startup to provide free medical facilities for the employees and their families in this current 21 days lockdown due to COVID-19 pandemic.   This association will help mCaffeine employees and their families to get access to 24*7 medical support and unlimited and free consultations with doctors on call through their helpline number. All doctors are qualified (MBBS or specialization), with extensive training in telemedicine. Post the consultation; a signed prescription will be shared on SMS/WhatsApp & the Clinikk App. If a further diagnosis requires lab tests, the sample will get collected at home. Employees can also order medicines online and can get benefited from discounts.  Tarun Sharma, co-founder & CEO, mCaffiene said, “The need of the hour is to extend maximum possible support to your employees and their families. Besides assuring the job and financial security, it is pertinent to take care of their physical and mental well being. In a lockdown scenario when one cannot step out of their home more so because of the spread of a highly contagious virus, its our responsibility to take care of their health needs. We don’t want them to compromise or neglect themselves. In such a panic scenario one may not know whom to approach or where to go.  While all employees are working from home; we want them to be tension free regarding any health problems of themselves and their families by providing them door-step medical facilities. Clinikk app which gives a one-stop solution will provide the much required ease and convenience. Employee wellness is prime at mCaffeine. More than 400 people will benefit from this association.’’ Bengaluru based health tech startup, Clinikk is revolutionizing the approach to healthcare in India, by building a one-stop solution for all healthcare needs at just one-phone-call-away. The ability of Clinikk is to diagnose and treat certain ailments using remote technology instead of person-to-person contact, thereby creating ease of access to medical care.  “At Clinikk we believe in becoming the first point of contact for any medical need that a family might have. Being there for them 24*7 ensures that we are able to detect any medical problem proactively at its onset and make necessary intervention before it manifests itself as a more serious issue&quot;, Said, Bhavjot Kaur, co-founder of Clinikk Healthcare. Apart from doctor consultations, if any medical information is required for eg. partner hospitals, it can be directed to the Health Assistants, who provide relevant, accurate information. Based on seasonal change, medical history etc. - Clinikk provides personalized awareness building information through WhatsApp, SMS and IVR calls. The languages currently supported are; English, Hindi, Kannada, Tamil, Telugu, Malayalam, Bangla, Assamese, Marathi. ]]> <![CDATA[Lanxess India donates disinfectants to Thane Municipal Corporation]]> https://biospectrumindia.com/news/95/16050/lanxess-india-donates-disinfectants-to-thane-municipal-corporation.html https://biospectrumindia.com/news/95/16050/lanxess-india-donates-disinfectants-to-thane-municipal-corporation.html Sat, 28 Mar 2020 00:00:00 +0530 To help fight the current COVID-19 pandemic in India, specialty chemicals company LANXESS India has donated its highly effective Rely+On™ Virkon™ disinfectant to Thane Municipal Corporation (TMC) to reduce the cross contamination of COVID-19 in civic hospitals and other establishments.  Rely+On™ Virkon™ inactivates coronavirus quickly With regard to the current global Coronavirus situation, independent tests have proven that Rely+On™ Virkon™ quickly inactivates a closely related surrogate of the currently spreading coronavirus strain. From these tests it can be concluded that Rely+On™ Virkon™ would also be effective against SARS-CoV-2 which is causing the current COVID-19 epidemic. The independent test results indicated that Rely+On™ Virkon™ achieved inactivation of the coronavirus strain at a 1:100 dilution rate with a 10-minute contact time. This corresponds to test conditions required by the U.S. Environmental Protection Agency (EPA) and proves the performance and suitability of Rely+On™ Virkon™ for practical use. Rely+On™ Virkon™ is diluted for application and sprayed on hard surfaces and equipment. It can therefore help to reduce the risk of cross contamination from surfaces, door handles, tables or chairs during disinfection measures at public transport terminals, airports, hospitals, clinics, shopping malls, etc. Due to this wide application range, there has been a significant increase in demand from the Indian industry as many private hospitals and several corporations have placed significant orders of the disinfectant in their own efforts to limit the spread of the disease in their organizations. Neelanjan Banerjee, Vice Chairman and Managing Director, LANXESS India commented, “We are working concertedly to ensure that our production and logistics capacities are optimally aligned to cater to the surge in demand for Rely+On Virkon. We are committed to fully utilize our product expertise to help fight the spread of COVID-19.” ]]> <![CDATA[Global Biopharma Industry pulls out all stops to address COVID-19]]> https://biospectrumindia.com/news/95/16048/global-biopharma-industry-pulls-out-all-stops-to-address-covid-19.html https://biospectrumindia.com/news/95/16048/global-biopharma-industry-pulls-out-all-stops-to-address-covid-19.html Fri, 27 Mar 2020 17:00:00 +0530 The International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), representing the world’s leading biopharmaceutical companies, has confirmed that having already mobilized on an unprecedented scale to respond to the COVID-19 pandemic, they commit to do more. The biopharmaceutical industry commits to accelerate its effort to use its skills, technology and resources to bring safe, effective diagnostics, treatments and vaccines to patients around the world as a matter of urgency. David Ricks, Chairman and CEO of Eli Lilly and Co and IFPMA President, said: “We are sending a clear signal of how seriously industry is taking the pandemic and the need to act as one team. So, we are sharing our commitments on how we, as an industry, are stepping up to do all we can to fight this pandemic”. The commitments demonstrate the combined will of leading companies in the field to share scientific expertise, technical skills and manufacturing capabilities to bring forward therapies and vaccines to protect humankind from this escalating pandemic. The biopharmaceutical industry is uniquely positioned to work in partnership with governments, the WHO and health systems across the world in a concerted, collective response. Among the commitments are to: use industry’s expertise and know-how to speed up the development of safe and effective vaccines, partnering with others to make it possible; use industry’s medical expertise to support global healthcare systems to manage the unprecedented increase in pressure they face; share tools and insights to test potential therapies and vaccines as well as developing and scaling up capacity ofdiagnostics for testing for COVID-19 patients as much as possible; increase industry’s manufacturing capabilities and willingly share available capacity to ramp up production once a successful vaccine or treatment is developed; work to secure continuity of supply for all essential medicines, vaccines and diagnostics for patients with other life-threatening diseases, calling on governments to implement policies and decisions that facilitate access for those in need. Biopharmaceutical companies began screening their libraries of medicines to identify potential treatments once the novel coronavirus (SARS-CoV-2) genome sequence was shared, building on the knowledge gained from decades of experience with new viruses such as SARS, MERS, Zika, and Ebola. The industry has devoted significant resources and worked with partners in public health to develop technologies that have dramatically shortened the time it takes to decode viruses and develop a potential vaccine. Hence, platforms are available to facilitate development of vaccines that swiftly enter clinical trials. Today, more than 80 clinical trials are underway to test new and existing medicines. At least nine IFPMA member companies are researching and developing new diagnostic tests, vaccines or treatments and testing existing medicines to treat those infected with the virus. Other companies are involved in fast-tracking diagnostic technology to help detect cases more rapidly. There is an unprecedented level of collaboration taking place across the industry as it joins hands with public agencies to further accelerate the development of new diagnostic tests, vaccines and treatments for patients. Numerous collaborative research programmes have been agreed in order to fast-track the development of therapeutics and vaccines with institutions such as BARDA, CEPI, IMI and others. The biopharmaceutical industry commits to continue collaborating with government agencies, academia and other health care stakeholders to ensure patients get the care they need. Thomas Cueni, IFPMA Director General, says the gravity of the COVID-19 pandemic demands extraordinary efforts across the board. He declares: “Society needs to know it can count on the biopharmaceutical industry to work to rapidly bring forward therapies, vaccines and diagnostics that protect humankind from this escalating pandemic and prepare the industry to better respond to future global health crises”. He adds: “My first thoughts are obviously with all those impacted by the pandemic”. The gravity of the situation calls for an unprecedented one-team approach across the entire pharmaceutical industry: “We need to rally around this action plan that demonstrates our willingness to act”. The profound global impact of the COVID-19 pandemic means business as usual is not an option. It is posing a serious threat to the functioning of healthcare systems and to healthcare professionals. If not contained, the expected impact of COVID-19 on all health systems, let alone weaker health systems in low- and middle-income countries, will be devastating. ]]> <![CDATA[Jubilant Life Sciences gives free hand sanitizers to fight against COVID-19]]> https://biospectrumindia.com/news/95/16046/jubilant-life-sciences-gives-free-hand-sanitizers-to-fight-against-covid-19.html https://biospectrumindia.com/news/95/16046/jubilant-life-sciences-gives-free-hand-sanitizers-to-fight-against-covid-19.html Fri, 27 Mar 2020 00:00:00 +0530 Jubilant Life Sciences Limited, a Jubilant Bhartia Group company, announced that its research and development team has developed formulation for hand sanitizer using its own produced Ethanol. The company got necessary approvals & has quickly realigned its manufacturing facility to start producing hand sanitizers at a short notice. This was made possible due to support byGovernment of Uttar Pradesh & its departments, who gave all the necessary approvals in record time, including Food Safety and  Drug Administration, the Excise Department and the Uttar Pradesh Pollution Control Board. Jubilant Life Sciences has started supplying, free of cost, these hand sanitizers to Governments both at the national &amp; the state level. Noida Administration, Government Hospital, Municipal, District Administration, Police Personnel at Jyotiba Phuley Nagar and Gautam Budha Nagar and the healthcare staff &amp; volunteers working at All India Institute of Medical Sciences, Delhi have received the first instalment. Government of India has taken commendable actions against the spread of COVID-19. Jubilant Bhartia Group companies are committed to support these measures through the supply of hand sanitizers to the healthcare workers in the hospitals and in the field, to control the spread of thispandemic. ]]> <![CDATA[Mylab develops fast Covid-19 test kits for government and private labs]]> https://biospectrumindia.com/news/95/16038/mylab-develops-fast-covid-19-test-kits-for-government-and-private-labs.html https://biospectrumindia.com/news/95/16038/mylab-develops-fast-covid-19-test-kits-for-government-and-private-labs.html Thu, 26 Mar 2020 17:00:00 +0530 Pune-based molecular diagnostics company Mylab Discovery Solutions Pvt Ltd the developed first Made in India Covid-19 testing kit on Wednesday announced that it is ready with the first batch of test kits and will start supplying to the government and private labs.  In the first batch, Mylab Discovery Solutions will supply testing kits to conduct 15,000 tests. The kit is the first one to receive commercial approval from Indian FDA/ Central Drugs Standard Control Organisation (CDSCO) and is developed in a record time of six weeks. Given the low testing rate in the country, India’s very own testing kit will help in fighting back the global pandemic Covid-19. Mylab PathoDetect COVID-19 Qualitative PCR kit screens and detects the infection within 2.5 hours, compared to 7+ hours taken by current protocols.“At present, Mylab can produce kits to test for 20,000 samples per day. However, in case of an adverse situation, the company can ramp-up its capacity to ship kits to conduct 50,000 tests per day.”, said, Rahul Patil, Executive Director and Operations Head, Mylab Discovery Solutions.  Mylab test kits cost nearly one-third to one-fourth of the cost of the price cap provided by ICMR. But private and government labs approved by ICMR can conduct the tests for Covid-19. As of 25th March, ICMR has approved more than 100 government labs and 29 private labs across the country for testing.“We are continuously working with all the testing labs to predict the demand and schedule the supplies of the testing kits.We are letting them know of supply schedules ahead of time”, said Sujit Jain, Advisor and Mentor on Corporate Strategy, Mylab Discovery Solutions.The Mylab manufacturing facility, approved by FDA/CDSCO is compliant with MDR 2017 regulation for Manufacturing Medical Device of Class A,B,C and D and ISO 13485: 2016 certification ]]> <![CDATA[Life Sciences firms collaborate with BMGF to fight COVID-19]]> https://biospectrumindia.com/news/95/16030/life-sciences-firms-collaborate-with-bmgf-to-fight-covid-19.html https://biospectrumindia.com/news/95/16030/life-sciences-firms-collaborate-with-bmgf-to-fight-covid-19.html Thu, 26 Mar 2020 11:45:00 +0530 A consortium of life sciences companies announced an important collaboration to accelerate the development, manufacture, and delivery of vaccines, diagnostics, and treatments for COVID-19. The life sciences industry brings a range of assets, resources, and expertise needed to identify effective and scalable solutions to the pandemic, which is affecting billions worldwide. The impact on health systems, economies, and livelihoods is profound, and an effective response requires an unprecedented collaboration across governments, academia, the private sector, and the philanthropic community.  As co-chair of a consortium life science companies headquartered across three continents, Vas Narasimhan, chief executive officer of Novartis, said, “We feel a deep shared responsibility to see if there are specific areas where collaboration across the life sciences industry and the Bill & Melinda Gates Foundation (BMGF) can accelerate solutions to this pandemic. In addition to the individual contributions companies are already making, collective action is critical to ensure any promising studies into vaccines, drugs, and diagnostics are quickly scaled to people around the world who are affected by this pandemic.” Trials of existing drugs, diagnostic tests, compounds, and investigational vaccines have begun across the globe to identify interventions that could slow or end the pandemic. Products that demonstrate efficacy will require clinical study, scale up of manufacturing, and distribution if proven effective. The life sciences industry has extensive experience in managing these processes for products that reach billions of people every day. Mark Suzman, chief executive officer of the Bill & Melinda Gates Foundation said, “We know that the private sector is where the technical skills and know-how regarding discovery, clinical trials, and commercialization sit. We look to harness that knowledge and experience—combining it where possible—to connect with national regulators and the World Health Organization to see if we can help flatten the curve of this epidemic and make sure the results reach everyone around the world, particularly those at highest risk and the poorest.” Following a conference call with Gates Foundation leadership earlier this month, companies are working to identify concrete actions that will accelerate treatments, vaccines, and diagnostics to the field. As a first step, 15 companies have agreed to share their proprietary libraries of molecular compounds that already have some degree of safety and activity data with the COVID-19 Therapeutics Accelerator—launched by the Gates Foundation, Wellcome, and Mastercard two weeks ago—to quickly screen them for potential use against COVID-19. Successful hits would move rapidly into in vivo trials in as little as two months. “This is an encouraging start in a critical area, because if any of these compounds are shown to be effective against COVID-19, it dramatically accelerates the path to product approval and scale up. While each of the consortium’s partners will also be pursuing independent efforts with national governments and others, we are optimistic that this unprecedented collaboration will provide a platform for a fundamentally different kind of partnership to help address this global health emergency", said Suzman. Companies participating in the collaboration include BD, bioMérieux, Boehringer Ingelheim, Bristol-Myers Squibb, Eisai, Eli Lilly, Gilead, GSK, Johnson & Johnson, Merck (known as MSD outside the U.S. and Canada), Merck KGaA, Novartis, Pfizer, and Sanofi. ]]> <![CDATA[Cipla receives final approval for Esomeprazole ]]> https://biospectrumindia.com/news/95/16029/cipla-receives-final-approval-for-esomeprazole-.html https://biospectrumindia.com/news/95/16029/cipla-receives-final-approval-for-esomeprazole-.html Thu, 26 Mar 2020 11:25:00 +0530 Cipla has announced that it has received final approval for its Abbreviated New Drug Application (ANDA) for Esomeprazole for Oral Suspension 10mg, 20mg and 40mg from the United States Food and Drug Administration (USFDA). It is the first company to file for the 10mg strength. Esomeprazole for Oral Suspension 10mg, 20mg and 40mg is AB-rated generic therapeutic equivalent version of AstraZeneca Pharmaceutical’s Nexium. It is a proton pump inhibitor indicated for the following: Treatment of gastroesophageal reflux disease (GERD). Risk reduction of NSAID-associated gastric ulcer. H. pylori eradication to reduce the risk of duodenal ulcer recurrence. Pathological hypersecretory conditions, including Zollinger-Ellison syndrome. According to IQVIA (IMS Health), Nexium and its generic equivalents had US sales of approximately $70M for the 12-month period ending November 2019. The product is available for shipping immediately.     ]]> <![CDATA[Akers Bio inks agreement with Premas Biotech for COVID-19 vaccine candidate]]> https://biospectrumindia.com/news/95/16018/akers-bio-inks-agreement-with-premas-biotech-for-covid-19-vaccine-candidate.html https://biospectrumindia.com/news/95/16018/akers-bio-inks-agreement-with-premas-biotech-for-covid-19-vaccine-candidate.html Wed, 25 Mar 2020 09:05:00 +0530 US based Akers Biosciences, Inc., a developer of rapid health information technologies, has announced that it has acquired a licensing agreement with Gurugram based Premas Biotech, under which Akers will in-license a novel coronavirus vaccine candidate under development by Premas using Premas’ genetically engineered S. cerevisiae platform, D-Crypt™, and partner with Premas to ultimately seek FDA approval. The current global crisis has created the potential for an expedited review process from the FDA, which has recently noted its willingness to fast-track human clinical trials for certain coronavirus candidates. Prabuddha Kundu, Co-Founder and Managing Director at Premas Biotech, added, “The strategic relationship today between Premas and Akers should accelerate our development timeline as we leverage the proven D-CryptTm platform and Akers’ 30 years of operational experience navigating the healthcare regulatory environment. We believe our platform has three key advantages which we believe will set our potential vaccine apart in the industry. First, it has successfully expressed more than 30 proteins of similar profile to those in the structure of COVID-19. We believe our platform is well suited for the expression of difficult vaccine candidate proteins, a key and difficult step in the process of developing a vaccine. Second, the technology platform is highly scalable with a robust process, which should represent significant cost savings compared to other similar vaccine platforms, which we believe is a key advantage to peers in the field. Third, we believe the current global pandemic might allow for an expedited FDA review timeline based on recent pronouncements regarding other COVID-19 vaccine and treatment candidates. In fact, we would hope to have material updates regarding proof of concept, drug design, and regulatory discussions in the near term.” Premas is utilizing its D-Crypt™ platform to recombinantly express the major structural proteins of the coronavirus. Based on genetically engineered baker’s yeast S. cerevisiae, D-Crypt™ is highly scalable into commercial production quantities and has been previously utilized for the production of multiple human and animal health vaccines candidates during its 10-year development track record. Prabuddha Kundu summarized, “Premas has worked successfully with global pharmaceutical companies over the past 14 years and has been recognized as one of the 20 key global manufacturers for difficult protein expression and production. We are experts in enabling gene to IND studies for drug and vaccine candidates and currently have four candidates in clinical trials globally for our partners. Our processes are robust, fast, and scalable, and aimed at reducing cost of goods, which if successful, will provide Akers with a significant competitive advantage as they move through the milestone pathway for an nCoV-19 vaccine.” Christopher Schreiber, Executive Chairman of Akers, stated, “Akers is a Nasdaq Listed company with a 30-year history in the development and manufacturing of rapid diagnostic tests. We have always been focused on solving global health challenges. After careful evaluation, partnering with Premas to address the global health pandemic of Coronavirus represents an important opportunity to leverage our expertise, leadership, and access to capital as a public company to end this threat. We are also evaluating the utilization of our facility with Premas for the development of this vaccine candidate as we move the product forward.” Under the terms of the agreement, Akers is acquiring Cystron Biotech LLC for a $1 million upfront payment, 622,756 shares of common stock or common stock equivalents and a royalty on net sales. In addition, Akers shall make additional payments of cash and stock to the sellers of Cystron Biotech LLC upon the achievement of certain milestones, along with a change of control. Akers is also required to make certain cash payments to Premas upon the achievement of additional milestones.  ]]> <![CDATA[Glenmark sells VWash brand to Hindustan Unilever ]]> https://biospectrumindia.com/news/95/16009/glenmark-sells-vwash-brand-to-hindustan-unilever-.html https://biospectrumindia.com/news/95/16009/glenmark-sells-vwash-brand-to-hindustan-unilever-.html Mon, 23 Mar 2020 17:00:00 +0530 Glenmark Pharmaceuticals Ltd, a research-led global pharmaceutical company has announced that it has entered into an agreement with Hindustan Unilever Limited (HUL) for divestment of its VWash brand and other extensions. Under this agreement, the brand and other trademarks, copyrights, know-how associated with Glenmark’s VWash business will be transferred to HUL. Glenmark will receive an upfront payment and royalty on sales for 3 years. No employees will be transferred as a part of this agreement. The transaction is expected to be completed in the next few months subject to customary approvals. Glenmark launched VWash, a liquid vaginal wash, as an OTC product in 2013.  Sujesh Vasudevan, President India Formulations, Middle East and Africa at Glenmark said, “The decision to divest VWash brand is driven by the strategy to focus on our core therapy areas. While Glenmark has been able to establish VWash as a category leader, we are confident that HUL’sstrong market presence and large distribution network will accelerate future growth of VWash.” Glenmark’s OTC business will focus on its other leading brands like Candid Powder, Scalpe and introduce new Rx to OTC switches. ]]> <![CDATA[Clinikk Healthcare launches protection plans against Coronavirus ]]> https://biospectrumindia.com/news/95/16007/clinikk-healthcare-launches-protection-plans-against-coronavirus-.html https://biospectrumindia.com/news/95/16007/clinikk-healthcare-launches-protection-plans-against-coronavirus-.html Mon, 23 Mar 2020 14:45:00 +0530 Clinikk Healthcare, the company behind India’s one-click/phone-call-away health companion has announced the launch of Coronavirus Support Plan- India’s first comprehensive protection plan against the Coronavirus disease (COVID-19). This new-age product will serve as a comprehensive healthcare safety net for individuals infected with the coronavirus, and ensure ongoing treatment for customers and their families in a hassle-free environment. Clinikk’s Coronavirus Support Plan provides customers with a 360-degree coverage of their health needs while infected with the coronavirus. Combining primary care and financial protection, customers are assured of end-to-end treatment services, including consultations with qualified doctors, 24*7 doctor assistance, and INR 1 lac insurance cover against any hospitalisation costs related to coronavirus. The company also offers an all-in-one insurance solution custom-designed to aid businesses and corporate concerns in ensuring the wellbeing of their staff in the face of the disease. Through this offering, Clinikk will support and enhance an organisation’s existing health services through awareness building, doctor consultations, and insurance products. Dr Suraj Baliga, Co-Founder of Clinikk Healthcare said, “COVID-19, the coronavirus disease, is a serious illness that poses a grave threat to public health. The ease with which it transfers between individuals has seen it rapidly spread across the world, and infect approximately 150,000 people in over 150 countries at present. As such, Clinikk Healthcare has chosen a course of proactive action in the face of this global health crisis. Through our newly launched plan, we offer both individuals and organisations a comprehensive package designed to handle every aspect of treatment in the event of infection. Additionally, we’ve also opened our teleconsultation lines to the public for free. This step will allow individuals to have their questions on the disease be answered by qualified professionals, allaying the stress placed on India’s public health system and reducing the spread of misinformation.”  In addition to these efforts, Clinikk has also taken steps to enhance its existing services by opening its teleconsultation channels to the general public for free. This move will allow concerned individuals to interface directly with qualified doctors for any questions they may have on coronavirus, including its symptoms, precautionary measures to take, and screening procedures.     ]]> <![CDATA[Glenmark receives tentative ANDA approval for Dapagliflozin Tablets]]> https://biospectrumindia.com/news/95/16001/glenmark-receives-tentative-anda-approval-for-dapagliflozin-tablets.html https://biospectrumindia.com/news/95/16001/glenmark-receives-tentative-anda-approval-for-dapagliflozin-tablets.html Mon, 23 Mar 2020 10:40:00 +0530 Glenmark Pharmaceuticals has announced the tentative approval by the United States Food & Drug Administration (USFDA) for Dapagliflozin Tablets, 5 mg and 10 mg, the generic version of Farxiga Tablets, 5 mg and 10 mg, of AstraZeneca AB. According to IQVIATM sales data for the 12-month period ending January 2020, the Farxiga Tablets, 5 mg and 10 mg market2 achieved annual sales of approximately $1.8 billion. Glenmark’s current portfolio consists of 165 products authorized for distribution in the U.S. marketplace and 45 ANDA’s pending approval with the USFDA. ]]> <![CDATA[FICCI welcomes Cabinet decision on Bulk Drug Parks ]]> https://biospectrumindia.com/news/95/16002/ficci-welcomes-cabinet-decision-on-bulk-drug-parks-.html https://biospectrumindia.com/news/95/16002/ficci-welcomes-cabinet-decision-on-bulk-drug-parks-.html Mon, 23 Mar 2020 00:00:00 +0530 Mr S Sridhar, Chair, FICCI Pharmaceuticals Committee and MD, Pfizer, India, today said, "The Indian pharma industry has been a world leader in generics both globally and in domestic markets contributing significantly to the global demand for generics in terms of volume. 'Made in India' drugs supplied to the developed economies such as the US, EU, Japan and many other countries are known for their safety and quality." India's large import dependence on China (nearly 70% by value) has become a significant threat to India's healthcare manufacturing and global supply chain. While Indian pharma companies over years have climbed up the value chain to focus on value-added formulations, but this over dependence on China has increased the threat to the nation's health security as some of these critical and complex APIs are crucial to address India's growing disease burden. "Government of India's decision for promotion of Bulk Drug Parks for financing Common Infrastructure facilities in 3 Bulk Drug Parks with financial implication of Rs 3,000 crore over next 5 years to boost domestic manufacturing of critical KSMs/ Drug Intermediates and APIs is a welcome move which FICCI and its pharma member companies widely support," said Mr Sridhar. "India should not look at these Bulk Drug Parks only for Domestic requirement. China became big supplier because of scale which looked into both domestic and export requirement. Domestic will not give scale and is always exposed to cost and pricing pressures. With this new policy initiative Government must look at incentivising the manufacturing of the critical 54 APIs which were recently restricted for exports and together with Industry should work for not just domestic capacities but fulfilling global export demands too," added Mr Sridhar. India needs to be seen as a World leader for not just Generic formulations but APIs too. Government of India's efforts to announce these parks with incentives in these testing global health threat times of COIVD19 are welcome and at right time. It reflects the direction, leadership and firm resolve of Prime Minister, Mr Narendra Modi to make India self-dependent and support the healthcare as a critical industry for the growth of the nation."We at FICCI whole heartedly support Prime Minister's vision which will drive toward enhancing India's API capacities," added Mr Sridhar ]]> <![CDATA[CII proposes strengthening of pharma, healthcare sectors amidst crisis]]> https://biospectrumindia.com/news/95/16003/cii-proposes-strengthening-of-pharma-healthcare-sectors-amidst-crisis.html https://biospectrumindia.com/news/95/16003/cii-proposes-strengthening-of-pharma-healthcare-sectors-amidst-crisis.html Mon, 23 Mar 2020 00:00:00 +0530 The Confederation of Indian Industry (CII) has brought out action points for strengthening the healthcare and pharmaceutical sectors for combating the Coronavirus crisis. The private sector can be support the Government in medical facilities, pharmaceuticals and medical equipment. On healthcare, CII has recommended that hospitals in larger cities, and district hospitals in smaller cities and towns, should be identified or designated as ‘COVID hospital’ for testing and isolation of patients. Private sector hospitals can contribute to the required equipment and the manpower. CII further suggested the adoption of widescale E-ICU/teleconsultation to tackle the spread of COVID-19, especially in its phase 3 and 4. CII has already set up the control centre and the backend systems required for E-ICU and these can be scaled up with the support of the Government, as necessary. On pharmaceuticals, CII said that the current situation makes a compelling case for Indian Government to declare API as a strategic sector as most inputs are imported.  Industry also suggests that firms for which capacity utilization is 40% may be permitted to produce API which are being imported. Approvals for new investments should be fast-tracked. CII has proposed that blanket environment permission be provided to manufacture any API on submission of self-certification to comply with pollution load requirement.  Other CII recommendations to strengthen API and intermediates production in the country include creation of large API parks with fiscal benefits for existing API and intermediates plants; supportive regulatory framework and common infrastructure facilitating single window clearances for API parks; boosting drug formulations from indigenous API and its intermediates; and providing incentives for new product development, processes and technology, among others. CII stated that the outbreak could lead to significant shortage of supply in the medical technology sector as well, especially for critical medicines and medical devices such as thermometers, nebulizers, glucometers, etc.  The medical devices market too is heavily import dependent, at around 70-80%, with imaging equipment (CT & MRI scanners), cardiac stents, orthopedic implants, glucometers, and critical care equipment cornering a large share. Many raw materials and components are imported from China. While the real impact on industry is likely to be visible only after April 2020, the local manufacturer’s capacities will need to be bolstered, which would likely become reliable sources amidst global shortages, said CII. ]]> <![CDATA[Dr. Reddy's launches generic Daraprim in US market]]> https://biospectrumindia.com/news/95/15994/dr-reddys-launches-generic-daraprim-in-us-market.html https://biospectrumindia.com/news/95/15994/dr-reddys-launches-generic-daraprim-in-us-market.html Fri, 20 Mar 2020 14:00:00 +0530 Dr. Reddy’s Laboratories has announced the launch of Pyrimethamine Tablets USP, 25 mg, a therapeutic equivalent and first-wave generic version of Daraprim® (pyrimethamine) Tablets, approved by the U.S. Food and Drug Administration (USFDA). This product is the only AB-rated generic version Daraprim® (pyrimethamine) Tablets approved by the USFDA. “I am extremely proud of our teams at Dr. Reddy’s and Cerovene whose hard work and efforts, coupled with significant financial investments over the past seven years journey, have helped bring this important product to market,” says, Marc Kikuchi, Chief Executive Officer, North America Generics, Dr.Reddy’s Laboratories. “Our team’s relentless pursuit of this difficult-to-procure reference drug and its active pharmaceutical ingredients—in addition to recent actions from the USFDA — will benefit patients by providing a more affordable alternative to the brand.” According to Kikuchi, the company is offering this product at a substantial discount compared with the current brand price. “The achievements of the Cerovene team to develop, file and manufacture Pyrimethamine Tablets is a testament to our dedication and commitment to be able to provide this product to the patients who need it most. We are pleased to collaborate with Dr. Reddy’s as our commercial partner to make this important drug available to patients in the U.S.,” says, Ray DiFalco, Co-Founder and Vice President of Operations for Cerovene. “This approval represents our continued commitment to develop and provide patients with greater choices and lower-cost alternatives for prescription pharmaceuticals.” In a recent press release regarding the approval of this product, the USFDA reiterated its commitment to improve “the efficiency of the generic drug development, review and approval process, as well as closing loopholes that allow brand-name drug companies to delay the generic competition.” The approval and launch of Dr. Reddy’s Pyrimethamine is a testament to the agency’s actions, providing generic drug companies the opportunity to compete fairly in the marketplace. Pyrimethamine is indicated for the treatment of toxoplasmosis when used conjointly with a sulfonamide, since synergism exists with this combination.The Daraprim® (pyrimethamine) brand had U.S. sales of approximately $10 million MAT for the most recent twelve months ending in January 2020 according to IQVIA Health*. Dr. Reddy’s Pyrimethamine Tablets USP, are available in 25 mg dose in bottle count sizes of 30 and 100. ]]> <![CDATA[Cipla inks agreement with IICT to develop COVID-19 drug]]> https://biospectrumindia.com/news/95/15991/cipla-inks-agreement-with-iict-to-develop-covid-19-drug.html https://biospectrumindia.com/news/95/15991/cipla-inks-agreement-with-iict-to-develop-covid-19-drug.html Fri, 20 Mar 2020 10:10:00 +0530 Mumbai based pharmaceutical company Cipla has teamed up with the Hyderabad based Council of Scientific & Industrial Research-Indian Institute of Chemical Technology (CSIR-IICT) to develop potential candidates for treating COVID-19. Scientists from IICT will be working of existing anti-viral drugs like remdesivir, favipiravir and bolaxavir. Further on, Cipla will start the next phase of trials, take up regulatory authority approvals and subsequent mass production of the anti-viral drugs, for the treatment of COVID-19.   ]]> <![CDATA[Dr. Reddy's announces the launch of Ziprasidone Mesylate ]]> https://biospectrumindia.com/news/95/15972/dr-reddys-announces-the-launch-of-ziprasidone-mesylate-.html https://biospectrumindia.com/news/95/15972/dr-reddys-announces-the-launch-of-ziprasidone-mesylate-.html Tue, 17 Mar 2020 16:10:00 +0530 Dr. Reddy’s Laboratories has announced the launch of Ziprasidone Mesylate for Injection, 20 mg (base)/mL Single-dose Vials, the therapeutic generic equivalent of Geodon® (ziprasidone mesylate) Injection, 20 mg/mL, approved by USFDA. Marc Kikuchi, Chief Executive Officer, North America Generics, Dr. Reddy’s Laboratories said, “We’re pleased to bring the first generic of Ziprasidone Mesylate for Injection to market for patients who will benefit from access to affordable medicine. With every new product launch, we believe we are making healthcare more affordable by delivering value to the pharmacy. This is a great addition to our injectable offering in the U.S. market as we continue to augment our portfolio and drive growth within the hospital segment.” The Geodon® brand had U.S. sales of approximately $21.8 million MAT for the most recent twelve months ending in January 2020 according to IQVIA Health. ]]> <![CDATA[Lasa & ICT explore Favipiravir therapy against COVID-19]]> https://biospectrumindia.com/news/95/15970/lasa-ict-explore-favipiravir-therapy-against-covid-19.html https://biospectrumindia.com/news/95/15970/lasa-ict-explore-favipiravir-therapy-against-covid-19.html Tue, 17 Mar 2020 11:40:00 +0530 API major, Lasa Supergenerics Ltd In collaboration with the Institute of Chemical Technology (ICT) recently announced commencement for the Development of antiviral Compound Favipiravir as Covid19 Treatment. Commenting on the development, Dr. Omkar Herlekar, Chairman– Lasa Supergenerics Limited, said Health and safety of our countrymen is of pristine importance and to safeguard them from deadly corona we have joined hands with one of Government recognised Institute in India “Institute of Chemical Technology” to develop Favipiravir for Treatment of “COVID19” which has currently emerged as a pandemic. We are working together with all our efforts to commence the research and scale-up activity of Favipiravir, antiviral drug, showing its promising activity for inhabitation of wide range of viruses, we will take necessary steps for getting permission from Drug Controller General of India to Launch product in Indian Market at the earliest, Once the Favipiravir therapy is approved by global regulatory authorities we would approach DCGI for conducting required bioequivalence clinical trials in India and also seek for strategic private investments and/or Government aid to commercialise this product subject to all regulatory approvals and trials. About ICT, Institute of Chemical Technology (ICT) Formerly the University Department of Chemical Technology (UDCT) is a Public deemed University specialized in Chemical Technology located in Mumbai, India. It is focused in training and research in various branches of chemical engineering, chemical technology and pharmacy.  Commenting on the Collaboration, Dr Vikas Terlvekar, Professor– Institute of Chemical Technology (ICT) Said, we appreciate this great step by Lasa Supergenerics Ltd and Dr.Omkar which shall help nation and support government to treat this deadly Covid-19, we have accepted the challenge to fight against virus with each other’s support and expect to succeed the battle.  Favipiravir is an antiviral drug and is a promising antidote for the treatment of Coronavirus disease (COVID-2019). It possesses activity against many RNA viruses. It is a guanine analogue approved for influenza treatment. It can effectively inhibit the RNA-dependent RNA polymerase of RNA viruses such as influenza, Ebola, yellow fever, chikungunya, norovirus and enterovirus, and a recent study reported its activity against 2019-nCoV. ]]> <![CDATA[Lasa, ICT to use Favipiravir therapy to fight COVID 19]]> https://biospectrumindia.com/news/95/15969/lasa-ict-to-use-favipiravir-therapy-to-fight-covid-19.html https://biospectrumindia.com/news/95/15969/lasa-ict-to-use-favipiravir-therapy-to-fight-covid-19.html Tue, 17 Mar 2020 10:10:00 +0530 Mumbai based API major, Lasa Supergenerics Ltd In collaboration with the Institute of Chemical Technology (ICT) recently announced commencement for the development of antiviral compound Favipiravir as Covid19 treatment. Commenting on the development, Dr. Omkar Herlekar, Chairman– Lasa Supergenerics Limited, said "We are working together with all our efforts to commence the research and scale-up activity of Favipiravir, antiviral drug, showing its promising activity for inhabitation of wide range of viruses, we will take necessary steps for getting permission from Drug Controller General of India to Launch product in Indian Market at the earliest, Once the Favipiravir therapy is approved by global regulatory authorities we would approach DCGI for conducting required bioequivalence clinical trials in India and also seek for strategic private investments and/or Government aid to commercialise this product subject to all regulatory approvals and trials. Commenting on the Collaboration, Dr Vikas Terlvekar, Professor– Institute of Chemical Technology (ICT) Said, we appreciate this great step by Lasa Supergenerics Ltd and Dr.Omkar which shall help nation and support government to treat this deadly Covid-19, we have accepted the challenge to fight against virus with each other’s support and expect to succeed the battle. Favipiravir is an antiviral drug and is a promising antidote for the treatment of Coronavirus disease (COVID-2019). It possesses activity against many RNA viruses. It is a guanine analogue approved for influenza treatment. It can effectively inhibit the RNA-dependent RNA polymerase of RNA viruses such as influenza, Ebola, yellow fever, chikungunya, norovirus and enterovirus, and a recent study reported its activity against 2019-nCoV. ]]> <![CDATA[OPPI commits to address COVID-19 situation in India]]> https://biospectrumindia.com/news/95/15964/oppi-commits-to-address-covid-19-situation-in-india.html https://biospectrumindia.com/news/95/15964/oppi-commits-to-address-covid-19-situation-in-india.html Mon, 16 Mar 2020 15:10:00 +0530 In line with its patient-first approach, Organisation of Pharmaceutical Producers of India (OPPI), which represents the research-based pharmaceutical companies, reiterates the support and commitment of its members towards working with the Government of India in addressing the COVID-19 situation by ensuring: Supply Continuity of Medicines: OPPI and its member companies reassure availability of adequate supplies of medicines for those in need of them. OPPI confirms that currently its member companies have adequate inventory in India and efforts are being made to step up further production. OPPI members are committed to working on measures to ensure that there are no shortages and that there is continuity in the pharmaceutical supply chain through a focused engagement with all critical stakeholders across the supply chain. Response to public health challenge driven by scientific research: As a science-driven industry that aims to address some of the world’s biggest health care challenges, the research-based pharmaceutical industry clearly has a role to play in developing new and improved medicines and vaccines to help respond to this epidemic. From the outset of the epidemic, global research-based pharmaceutical companies have reviewed their drug and vaccine portfolios to see if there is any research that could be of help. This analysis involved scientists assessing the companies’ libraries for potentially useful assets that could help with the development of new or repurposed treatments or vaccines to fight against the novel coronavirus: Relevant assets include diagnostics and biomarkers, approved therapies or compounds in development which could be repurposed for use in treating patients with the coronavirus. In addition, these companies are undertaking to identify any ACE inhibitors, protease inhibitors or immunotherapies that could be relevant in the context of novel coronavirus. Health & Safety of Employees: In line with the advisories issued by the Government and Ministry of Health & Family Welfare on COVID-19, OPPI members are tracking the updates and implementing them on a regular basis. In view of addressing the safety, well-being and good health of employees, partners and other stakeholders, members are committed to following the general precautionary measures that include the universal or standard precautions of general hygiene; maintaining a social distancing of 2 meters or more and avoiding mass gatherings. Members have postponed internal and external meetings, events & gatherings, and travels, until further notice.      ]]> <![CDATA[Serum Institute collaborates with Novavax for malaria vaccine]]> https://biospectrumindia.com/news/95/15951/serum-institute-collaborates-with-novavax-for-malaria-vaccine.html https://biospectrumindia.com/news/95/15951/serum-institute-collaborates-with-novavax-for-malaria-vaccine.html Fri, 13 Mar 2020 09:25:00 +0530 US based Novavax, Inc., a late-stage biotechnology company developing next-generation vaccines for serious infectious diseases, and Serum Institute of India (SII) have announced a commercial license agreement for the use of Novavax’ proprietary Matrix-M™ vaccine adjuvant with SII’s malaria vaccine candidate. SII licensed the R21 malaria vaccine, which targets the most severe plasmodium falciparum-induced malaria disease, from the Jenner Institute at Oxford University in 2017. Matrix-M is a key component in the malaria vaccine candidate, currently in a Phase 2b clinical trial sponsored by the Jenner Institute, with top-line data expected to be reported in the second quarter of 2020. Under the terms of the agreement, SII is granted rights to use Matrix-M in the vaccine in regions where the disease is endemic and will pay Novavax royalties on its market sales of the vaccine. Matrix-M will be manufactured and supplied to SII by Novavax AB, a wholly-owned subsidiary of Novavax based in Uppsala, Sweden. In addition, as part of the arrangement, Novavax has gained the rights to sell and distribute the SII-manufactured vaccine in high-income countries, primarily in the travelers and military vaccine markets. ]]> <![CDATA[Lupin receives ISRS certification]]> https://biospectrumindia.com/news/95/15947/lupin-receives-isrs-certification.html https://biospectrumindia.com/news/95/15947/lupin-receives-isrs-certification.html Fri, 13 Mar 2020 06:00:00 +0530 Pharma major Lupin Limited (Lupin) has announced that the Company has received certification for International Sustainability Rating System (ISRS), 8th edition, from DNV GL, a global service provider for managing risk and helping customers to safely and responsibly improve their business performance. The certification was received after audits were conducted at four of the company’s manufacturing facilities located at Mandideep, Tarapur, Ankleshwar and Dabhasa, in India. The results were declared on 6th March 2020. ISRS is a leading global system to assess, improve and demonstrate the health of an organization’s business processes. The ISRS certification helps ensure that business operations are safe and sustainable. Commenting on the certification, Mr. Rajendra B. Chunodkar, President - Manufacturing Operations, Lupin said, “Lupin had first received the ISRS 8th edition certification in 2013 and was then the first pharmaceutical company globally to be recognized by DNV. Maintaining the certification and improving this year’s ranking by achieving the highest level for three of our locations endorses the best practices we have adopted in Risk Management, Safety and Sustainability at our manufacturing sites.”   ]]> <![CDATA[Biocon & Mylan win patent litigation by Sanofi for Insulin Glargine Device in US]]> https://biospectrumindia.com/news/95/15946/biocon-mylan-win-patent-litigation-by-sanofi-for-insulin-glargine-device-in-us.html https://biospectrumindia.com/news/95/15946/biocon-mylan-win-patent-litigation-by-sanofi-for-insulin-glargine-device-in-us.html Thu, 12 Mar 2020 12:35:00 +0530 Biopharmaceutical firm Biocon Ltd and its partner Mylan have won a U.S. court ruling that invalidated a Sanofi patent on the Insulin Glargine device, removing a key legal hurdle to commercializing Semglee (Insulin Glargine) co-developed by Biocon and Mylan, in the U.S. The U.S. District Court of New Jersey found the device patent claims asserted by Sanofi against Biocon and Mylan’s Insulin Glargine product ‘not infringed’ and ‘invalid’ for lack of written description. Dr Christiane Hamacher, CEO, Biocon Biologics said, “We are extremely pleased with the U.S. court ruling in favour of our Insulin Glargine device as this takes us closer towards bringing a more affordable Insulin Glargine for patients with diabetes in the U.S. Today, patients in parts of Europe, Australia, India and key emerging markets are already benefiting from our Insulin Glargine. Once approved and commercialized our Semglee will expand access to this therapy. This patent win endorses our commitment to innovation and value creation through incisive IP strategy. Biocon Biologics remains committed to use its science, scale and expertise to shift the access paradigm for patients in need of insulins across the globe.” Biocon remains confident of being able to commercialize the product in calendar year 2020. The market opportunity for Insulin Glargine in the U.S. is estimated at US$ 2.2 billion.              ]]> <![CDATA[Important to fast-track regulatory clearances for the COVID-19 vaccine: Adar Poonawalla]]> https://biospectrumindia.com/news/95/15936/important-to-fast-track-regulatory-clearances-for-the-covid-19-vaccine-adar-poonawalla.html https://biospectrumindia.com/news/95/15936/important-to-fast-track-regulatory-clearances-for-the-covid-19-vaccine-adar-poonawalla.html Wed, 11 Mar 2020 14:15:00 +0530 At the forefront of discovering effective treatments and vaccines to combat the outbreak of COVID-19, coronavirus; Serum Institute of India Pvt. Ltd. (SIIPL), the world's largest vaccine manufacturer by number of doses produced and sold globally recently stated that the vaccine for COVID-19 will require fast-tracking of regulatory clearances, and a due diligence of ethics and safety standards for it to be market ready by 2022. Following the same, the development has now progressed to the pre-clinical test phase i.e. the animal trial phase, with results awaited to release in the next two months. In a bid to generate a vaccine candidate at the earliest, the SII-Codagenix developed novel coronavirus virus-vaccine strain is pegged as the first in its form to progress to the pre-clinical trial phase. Talking about the urgent need to formulate a robust way ahead to control the global pandemic, Adar Poonawalla, CEO, SIIPL said, “SII and Codagenix have been working with utmost diligence and meticulous effort to develop a preventive vaccine against the novel coronavirus. The vaccine-virus strain is identical to the original virus and can generate a robust immune response. At present we are the pre-clinical phase, i.e. the animal trial phase. In two- month time, we hope to get some results on the animal studies and then based on the regulatory path we take, and which countries allow for the most ethical and fastest approval clearance for the human trial phase; the way ahead will be determined.” SIIPL seeks to do its clinical trials in India, while adhering to all the ethics and safety standards prescribed by the Government of India, however, the final decision is yet to be taken and will be dependent on varied factors. The vaccine-virus strain will be the fastest ‘Made in India’ vaccine to progress to the human trials phase within six months, if succeeded. The cost of the project has been estimated at INR 300 crores, SII aims to secure external funding for the project via various global partners. Adding to the above, Mr. Poonawalla, said, “The company plans to do its clinical (human) trials in India, adhering to the ethics and safety standards. We have also been approached by other companies and things are in process. As the vaccine leaders of the world, we should step up and contribute towards combatting these kinds of pandemics.” Highlighting on the manufacturing challenges he added, “This product will have to be handled under BSL 3 (biosafety level) conditions which basically is a very high containment level. I don't know how many facilities in the world have high volume manufacturing in BSL 3, we don't. We will have to see if this can be toned down. Even if you have the vaccine the main challenge will be to manufacture it at a large volume.” Since the outbreak of COVID-19, coronavirus has claimed an estimated 3,300 lives worldwide while over 98,000 people have been infected by the virus. Recognized as a ‘global health emergency’ by the World Health Organization, proactive and urgent strides are being made by global institutions and drug-makers towards finding a viable cure in controlling the outbreak. Marching towards generating a vaccine candidate, SIIPL had recently announced its partnership with American Biotechnology firm, Codagenix.     ]]> <![CDATA[ Lupin wins India Pharma Leader Award at India Pharma 2020]]> https://biospectrumindia.com/news/95/15933/-lupin-wins-india-pharma-leader-award-at-india-pharma-2020.html https://biospectrumindia.com/news/95/15933/-lupin-wins-india-pharma-leader-award-at-india-pharma-2020.html Mon, 09 Mar 2020 00:00:00 +0530 Pharma major Lupin Limited (Lupin) won the coveted India Pharma Leader Award at the India Pharma 2020 and India Medical Device 2020 conference. This was the 5th edition of the event organized by FICCI in collaboration with the Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers, Government of India. Lupin was presented the award by Shri. Vijay Rupani, Chief Minister of Gujarat and Shri. D.V. Sadananda Gowda, Union Minister, Ministry of Chemicals and Fertilizers, Government of India. Speaking on this win, Nilesh D. Gupta, Managing Director, Lupin said, “We are delighted to receive the India Pharma Leader Award from the Department of Pharmaceuticals, Government of India. It is indeed a moment of pride for us. This award acknowledges our contributions toward strengthening the Indian Pharmaceuticals Market and recognizes our all-round performance.” This year, the event was held at Ahmedabad from March 5 – 7, 2020. The event theme focused on “Clarity on Changing Regulatory Scenarios,” and witnessed participation of more than 1,200 delegates from all over India. ]]> <![CDATA[Manipal Hospitals launches ‘Well Women Package’ ]]> https://biospectrumindia.com/news/95/15920/manipal-hospitals-launches-well-women-package-.html https://biospectrumindia.com/news/95/15920/manipal-hospitals-launches-well-women-package-.html Fri, 06 Mar 2020 14:55:00 +0530 In an endeavour to prioritise preventive healthcare and make women aware of a healthy life, Manipal Hospitals, Dwarka recently launched ‘The Well Women Package that aims at preventive measures for women. Celebrity chef Sanjeev Kapoor unveiled the Package and also provided tips for a healthy diet while demonstrating a quick recipe of a healthy salad on table every day. The event was organised to mark the International Women’s Day (March 8) and it also witnessed a brainstorming Panel discussion on ‘Healthy Diet= Healthy Women’ and survivors sharing their experience. Dr Yugal K Mishra, Chief of Clinical Services & Head of Cardiac Sciences, Manipal Hospitals Dwarka, New Delhi said, “We have aligned ourselves with this year theme of International Women’s Day – ‘An equal world is an enabled world.’ We have specially created the Wellness Package for Women and it aims at prioritising preventive healthcare. We firmly believe that all is well when women are well in our family.”  “Women’s Health need to be dealt holistically. I strongly recommend women to go for regular check-ups and the government should also come out guidelines for their overall wellbeing. Today, we encourage them to pay attention to a healthy diet and that will make them healthy”, he added. Celebrity Chef Sanjeev Kapoor while expressing concerns over the neglect of health by women and lack of adequate access to healthcare said, “It should remind all of us that a woman plays the numerous roles but at the same time she neglects her health. Lack of timely access or delay in treatment aggravates their problems. Hence women’s timely access to healthcare without any bias is a very critical issue and we urgently need to address this.’’ Dr Leena Sridhar, Consultant Obstetrics & Gynaecology said, “Personal health takes a backseat for most women, with their hectic schedule of taking care of work, home, and all the people in their lives. This Women’s Day we should make a positive change and encourage them to make health a priority.” Over 100 women from all walks of life participated in the event and availed the Package that will encourage them to focus on their wellness.     ]]> <![CDATA[Zydus brings world's first drug for treating NASH]]> https://biospectrumindia.com/news/95/15916/zydus-brings-worlds-first-drug-for-treating-nash.html https://biospectrumindia.com/news/95/15916/zydus-brings-worlds-first-drug-for-treating-nash.html Thu, 05 Mar 2020 17:35:00 +0530 Zydus Cadila, an innovation-driven global pharmaceutical company has announced that the Drug Controller General of India (DCGI) has approved its New Drug Application (NDA) for Saroglitazar for the treatment of Non-Cirrhotic Non-Alcoholic SteatoHepatitis (NASH) in India. The drug will enter the Indian market within three months. The drug will also be launched in Mexico soon. NASH is a progressive disease of the liver, which starts with fat accumulation in the liver known as Non-Alcoholic Fatty Liver Disease (NAFLD). This condition could progress to cirrhosis and liver failure.  It is a large unmet medical need as there is currently no approved drug for the treatment of NASH anywhere in the world, a disease that is highly prevalent with 10% to 30% of the global population being affected by it. The prevalence of NASH in India is estimated to be nearly 25% of the population. NASH ranks as one of the major causes of cirrhosis, behind hepatitis C and alcoholic liver disease. Liver transplantation is the only option for managing advanced cirrhosis with liver failure. Speaking about the development, Pankaj Patel, Chairman, Zydus Group mentioned, “We are happy that our efforts to discover and develop a novel drug for patients living with NASH, an unmet healthcare need globally have been successful. Saroglitazar will provide hope and new lease of life for millions of patients in India suffering from NASH.” Saroglitazar was launched in India in September 2013, for the treatment of diabetic dyslipidemia and hypertriglyceridemia in patients with type-2 diabetes not controlled by statins alone. In January this year, Saroglitazar received an approval for the treatment of Type 2 Diabetes Mellitus. In the last seven years, over a million patients have benefitted from this drug. Saroglitazar is uniquely poised with its dual PPAR alpha and gamma properties – reducing the comorbidities (dyslipidemia, hypertriglyceridemia, diabetes mellitus) and causing NASH resolution.   ]]> <![CDATA[Strides launches two products in consumer healthcare market]]> https://biospectrumindia.com/news/95/15895/strides-launches-two-products-in-consumer-healthcare-market.html https://biospectrumindia.com/news/95/15895/strides-launches-two-products-in-consumer-healthcare-market.html Wed, 04 Mar 2020 09:50:00 +0530 Bangalore based consumer healthcare company, Strides Consumer Private Limited (SCPL), has announced its entry into western Indian with two uniquely developed products- NIXIT, an oral Nicotine Replacement Therapy (NRT) and JOINTFLEX, a topical analgesic cream for joint care. The company’s new move comes immediately after its recent successful expansion into eastern and northern markets, while it was first launched in south in 2019. SCPL is headed by industry veteran Mr. Subodh Marwah and it has two marquee investors - India Life Sciences Fund with ~74% holdings and Strides Pharma Science Ltd (a listed company) with ~26%. With its intense understanding about Indian consumer healthcare market, SCPL thrives to cater the Indian consumers with high quality and differentiated products inspired from the best of global products with Indian customization. NIXIT is a great tasting NRT Gum. NRT is the recommended first-line therapy by WHO and USFDA which helps to quit smoking. NIXIT follows the 3 months step down dosage schedule of NRT. At present, the NRT market is pegged at Rs 156 crore and projected to reach Rs 450 crore by 2023. SCPL’s NIXIT has launch its gums at a very attractive price point – Rs. 49 for 2 mg gum &amp; Rs 55 for 4 mg gum. In research, the flavour and mouth feel of NIXIT Gums has been highly appreciated by theconsumers. JOINTFLEX, a topical analgesic cream, helps build healthy joints. Fortified with super ingredients GLUCOSAMINE and CHONDROITIN SULPHATE, it provides powerful, fast-acting and long-lasting pain relief. While India is home to 180 million arthritic patients, most of the current topical analgesic products treat only muscle pain, leaving the huge section of joint pain unattended. JOINTFLEX is exclusively designed to address the joint pain segment and is a complete joint care product. JOINTFLEX has been a preferred brand in the US for over 20 years now and also helping consumers in 15 other countries. In India, it comes as an ayurvedic formulation. Speaking about the expansion, Mr. Subodh Marwah, CEO, Strides Consumer Private Limited said, “Today, the consumer healthcare sector in India is valued at $ 3 Bn and expected to witness a twofold growth by 2024. It is set to redefine itself with the increasing knowledge about preventative healthcare among customers and need for niche customer-centric products. In such a scenario, it is imperative for any brand to deliver a proven solution in order to achieve high customer confidence. And, this is perhaps what we want to deliver to our customers through our products. Our expansioninto the new geographic sphere testifies our vision to take our brand and products to every customer in the nation. Our products NIXIT and JOINTFLEX are based on advanced formulations with extensive research to ensure we cater to the requirements of every consumer.” Backed with a wide distribution network, SCPL is currently present in all the states of southern, eastern and northern regions. With today’s expansion, it aims to reach out to all the parts of western India with similar and robust distribution strategy. NIXIT Gum comes in two strengths – 2 mg for light smokers and 4 mg for heavy smokers, priced at Rs 49 and Rs 55, respectively.  JOINTFLEX comes in two packs – 15 g and 30 g, priced at Rs 65 and Rs 120, respectively. NIXIT can also be ordered through Amazon, e pharmacies and www.nixitindia.in. ]]> <![CDATA[Zydus receives Ph I approval for RA drug from DCGI]]> https://biospectrumindia.com/news/95/15900/zydus-receives-ph-i-approval-for-ra-drug-from-dcgi.html https://biospectrumindia.com/news/95/15900/zydus-receives-ph-i-approval-for-ra-drug-from-dcgi.html Wed, 04 Mar 2020 00:00:00 +0530 Zydus Cadila, an innovation-driven, global pharmaceutical company, announced that it has received approval from the Drug Controller General of India (DCGI) to initiate Phase I clinical trials for its Investigational New Drug (IND) ZYBK2, a New Chemical Entity (NCE) intended to treat Rheumatoid Arthritis (RA). RA is a progressive, systemic autoimmune disease that affects at least 1 in every 100 people worldwide. Autoimmune diseases cause the body’s immune system to mistakenly attack one’s own healthy normal tissues. In the case of RA, the body’s own immune system attacks the lining of joints and can affect other body organs as well. While its most visible hallmarks are pain, stiffness, inflammation and eventual deterioration of joints, patients also are at heightened risk for cardiovascular disease and other inflammatory complications. Nearly 13 million are estimated to suffer from the disease in India ZYBK2 has been specifically designed to inhibit HLA-DRB1 Shared Epitope (SE) that determines the susceptibility of a person to develop rheumatoid arthritis. The vast majority of RA patients carry this genetic sequence. Several studies have pointed out that the SE binds to cell-surface calreticulin and causes an inflammatory response and bone erosion, a characteristic feature present in millions of patients with RA. ZYBK2 inhibits this SE and calreticulin interaction. The molecule addresses a high unmet medical need and has a large market potential for the treatment of RA. Speaking on the development, Mr Pankaj Patel, Chairman, Zydus Group said, “There are significant unmet medical needs among patients with Rheumatoid Arthritis (RA). Unlike other therapeutic strategies for managing RA, targeting upstream molecular interactions with ZYBK2 is less likely to cause adverse events. This clinical trial will seek to find answers if inhibiting HLA-DRB1- mediated effects could provide a safe remedy for treating this debilitating disease”. The pioneering work on the SE concept that led to the identification of the discovery of the ZYBK2 molecule was conducted at the University of Michigan, in the laboratories of Dr Joseph Holoshitz, Professor of Internal Medicine, Division of Rheumatology and Dr Henry Mosberg, Tom D Rowe Collegiate Professor of Pharmacy of Medicinal Chemistry, College of Pharmacy. Zydus acquired the rights for this molecule and conducted all the development work including IND enabling nonclinical studies at Zydus Research Centre, the R&D hub of the Zydus Group ]]> <![CDATA[Strides receives USFDA approval for generic antibiotic capsules]]> https://biospectrumindia.com/news/95/15909/strides-receives-usfda-approval-for-generic-antibiotic-capsules.html https://biospectrumindia.com/news/95/15909/strides-receives-usfda-approval-for-generic-antibiotic-capsules.html Wed, 04 Mar 2020 00:00:00 +0530 Strides Pharma Science Limited (Strides) today announced that its step-down wholly-owned subsidiary, Strides Pharma Global Pte. Limited, Singapore, has received approval for Tetracycline Hydrochloride Capsules USP, 250 mg and 500 mg from the United States Food & Drug Administration (USFDA). The product is a generic version of Achromycin V Capsules, 250 mg and 500 mg, of Avet Pharmaceuticals Inc (previously Heritage Pharmaceuticals Inc.) According to IQVIA MAT data, the US market for Tetracycline Hydrochloride Capsules USP, 250 mg and 500 mg are approximately US$ 16 Mn. The product will be manufactured at the company’s flagship facility at Bangalore and will be marketed by Strides Pharma Inc. in the US market. The company has 123 cumulative ANDA filings with USFDA of which 84 ANDAs have been approved and 39 are pending approval. About Tetracycline Hydrochloride Capsules:- Tetracycline Hydrochloride Capsule is an antibiotic used to treat many different bacterial infections of the skin, intestines, respiratory tract, urinary tract, genitals, lymph nodes, and other body systems. In some cases, tetracycline Hydrochloride Capsule is used when penicillin or another antibiotic cannot be used to treat serious infections such as Anthrax, Listeria, Clostridium, Actinomyces. ]]> <![CDATA[Tricog raises $10.5M in Series B funding]]> https://biospectrumindia.com/news/95/15897/tricog-raises-10-5m-in-series-b-funding.html https://biospectrumindia.com/news/95/15897/tricog-raises-10-5m-in-series-b-funding.html Tue, 03 Mar 2020 00:00:00 +0530 Bengaluru based Tricog, one of the world’s largest healthcare analytics firms, has raised 10.5 million USD in Series B funding round from UTEC - The University of Tokyo Edge Capital, Japan; Aflac Ventures, LLC, Japan; TeamFund, USA and Dream Incubator, Japan. Existing investors Inventus Capital and Blume Ventures also participated in this round. The investment comes two years after Tricog’s Series A funding round, bringing the company’s total funding to 17.5 million USD. Since the previous round, Tricog has grown its presence in over 12 countries in South-East Asia and Africa. Tricog’s AI-powered platform has been used by over 3 million patients globally for wellness, screening and diagnosis of acute as well as chronic heart diseases. Founded in 2015 by Dr. Charit Bhograj, Dr. Zainul Charbiwala, Dr. Udayan Dasgupta and Abhinav Gujjar, Tricog leverages its deep medical and technology expertise, to provide Virtual Cardiology Services to remote clinics, powered by ground-breaking AI and medical experts. Tricog’sInsta ECG platform has been deployed in over 2,500 Cathlabs, Hospitals, Clinics and Diagnostic Centres to help diagnose and manage patients with critical cardiac diseases including heart attacks. The platform has been deployed across both government and private health care networks and has demonstrated a significant reduction in mortality and morbidity. Dr. Charit Bhograj, CEO & Founder said, “We have witnessed phenomenal growth from our initial investments, both in terms of footprints in new geographies as well as revenue growth. Through this round of investment, we reinforce our commitment to strengthen our AI-powered platform for faster diagnosis, expand our product line and establish strong presence in Africa and Asia including India, China and Japan.” Tricog has recently launched the InstaEcho platform for remote echocardiography with a focus on using AI to enable Point of Care Cardiac Ultrasound for the diagnosis of Heart Failure, Valvular Heart disease and screening for Congenital Heart Disease. Tricog is also awaiting USFDA approval for its proprietary DeepRhythm platform for real-time patient monitoring. Noriaki Sakamoto, Partner and Board Director, UTEC, Japan said: “Tricog is a shining illustration of a multidisciplinary deep-technology innovation originating in Asia while solving a large global unmet need.  As the lead investors of their Series A round in 2018, we were especially impressed with their scientific rigor, exemplary leadership, revenue prospects and commitment to saving lives. We are now proud to lead their Series B as well, and supplement Tricog with Japanese medical device partnerships and R&D collaborations.” Inventus Capital and Blume Ventures are the earliest investors in Tricog. Parag Dhol, Director, Inventus Capital, said  “The Tricog team is amongst the most well-rounded we have backed. It is a privilege to have a ringside seat as Dr. Charit, Zainul, Udayan and Abhinav build out a classy healthcare technology company.” Sanjay Nath, Managing Partner at Blume Ventures, quoted “We’ve seen Tricog’s evolution from an India-based ECG healthcare startup to an integrated, AI-driven full-stack ‘virtual cardiologist’ platform. Most Indian B2B startups have traditionally focused on Enterprise/SaaS.  We’re proud to see DrCharit and the co-founding team at Tricog  lead the way in building out deep-tech innovation, expanding product lines and creating impact by saving lives across developing markets globally”.  Yousuf Mazhar, Partner at TeamFund, an impact focused fund based in the US, said: “Tricog’s solution in low resource settings is a game changer by allowing not only instant ECG and Echo readings without a Cardiologist present, but also the ability to immediately detect life threatening situations such as heart attacks, allowing appropriate care to be administered in a timely manner.” Managing Director, Tomoyuki Shimada, Aflac Innovation Partners G.K. Japan, said, “It is an honor for Aflac Ventures, LLC. to invest in Tricog, an excellent professional team. We believe Tricog's approach using ECG plus AI should have a huge impact on our healthcare experience. As an insurance company, Aflac will seek possibilities collaborating with the Tricog team to achieve their mission and try to create opportunities in improving people's quality of life."   ]]> <![CDATA[Takeda India reaffirms commitment on World Rare Disease Day]]> https://biospectrumindia.com/news/95/15873/takeda-india-reaffirms-commitment-on-world-rare-disease-day.html https://biospectrumindia.com/news/95/15873/takeda-india-reaffirms-commitment-on-world-rare-disease-day.html Mon, 02 Mar 2020 08:00:00 +0530 India is grappling with the challenges posed by rare diseases. The absence of a rare disease policy, low disease awareness amongst patients and lack of accessibility to specialists are critical factors that make the rare disease patients furthermore vulnerable. The most common rare diseases identified in India are Haemophilia, Thalassemia, Sickle-cell Anaemia, Primary Immuno Deficiency, Lysosomal Storage Disorders such as Gaucher Disease, Fabry Disease, Hunter Syndrome and Pompe’s Disease.  To celebrate Rare Diseases Day, Takeda, a global, R&D-driven biopharmaceutical company has pledged to drive increased awareness around rare diseases in India through its Indian entity. The company is committed to support faster diagnosis and better access to treatments for patients with rare diseases. Speaking on the occasion of Rare Disease Day, Vineet Singhal, General Manager and Country Head, Takeda India, said “As a company, we are committed to serve patients suffering from rare diseases like Hunter’s syndrome, Gaucher and Fabry and support them in their disease journey to ensure improved quality of life. We intend to leverage and replicate curated initiatives and global best practices in India for the benefit of the patients.” Takeda has established practices in the rare disease space across the globe. Access to Medicine (AtM) is one such strategy that aims to address the broader structural barriers that prevent patients in underserved communities from receiving the care and treatment they need. The Access to Medicine Foundation and The Access to Medicines Index recognised and ranked Takeda at number five in 2018, where Takeda was also recognised as the biggest upward mover, moving up 10 places to rank number five. Gopal Agrawal, Head Market Access, Patient Advocacy and Patient Services, Takeda India, said: “As a part of the global community, Takeda has focused its efforts and approach to Access to Medicines (AtM) for the patients suffering with rare diseases. We concentrate our efforts to serve and support the patients through numerous initiatives. We engage with patient bodies, not-for-profit organisations, industry bodies and others to support the interest of patients.” The company believes access to healthcare and medicines should be universal by being accessible and available to the Patients across the country. Takeda is committed to help strengthen the healthcare systems in a sustainable way. Dr Sandeep Arora, Medical Affairs Head, Takeda India, said: “There are significant unmet medical needs in the management of rare disorders in India, and it is imperative that all stakeholders such as treating physicians, health-care providers, policy-makers and patient groups come together to ensure timely diagnosis and intervention. It is important to raise awareness about the treatable rare diseases so that patients diagnosed with such conditions can access early treatment and have better outcomes. With focus on patients, Takeda runs specific charitable access programs and patient assistance programs to help get access to treatment and ensure they lead near normal lives.” As part of International Rare Disease Day, Takeda globally has launched "Constellation of Rare Stars" to honour patients, families, caregivers, health care professionals and community members who have helped to “Reframe Rare.”   ]]> <![CDATA[ Oracura launches new range of smart water flossers ]]> https://biospectrumindia.com/news/95/15885/-oracura-launches-new-range-of-smart-water-flossers-.html https://biospectrumindia.com/news/95/15885/-oracura-launches-new-range-of-smart-water-flossers-.html Mon, 02 Mar 2020 00:00:00 +0530 Oracura, India’s leading pioneer of innovative dental healthcare products launches its avant-grade range of smart water flossers. The novel flossers reach every nook & cranny of mouth to help cope with the age-old oral health problems. It removes 99.9% plaque especially from hard to reach areas plummeting away bad breath and making you feel, clean and healthy.  Ideal for cleaning, the rich line-up is easy to use around critical areas like braces, bridges, and crowns and clinically proven to be 3 times more effective in removing plaque than the traditional approach. The technology used drives sophistication to the conventional string floss as it efficiently removes plaque around complex dental implants as well.   “We provide our customers with top-notch products while securing maximum functionality and ease of use. Our diverse range of water flossers is carefully devised to cater to specific needs and situations of different individuals. The majority of our efforts are emphasized on delivering wholesome dental hygiene for the user and balance out the rise of poor dental hygiene in the country”, said Mr. Sagar Awatad, Founder and Director, Oracura.   Water flossers secure a deeper cleanse by spraying water along the gum line. The ordinary floss serves the basic purpose while water flossers get deeper into the gum pockets to remove the majority of trapped food, debris, and plaque from hard-to-reach places. The enhanced accessibility is a bonus since it requires low manual work and the possibility of exercising a poor technique is also minimal.   Furthermore, the pulse-modulation technology used is quickly becoming instrumental in promoting gum health by flushing away bacteria responsible for gingivitis and other oral infections. It also massages the gums and stimulates treated areas to reduce gum bleeding.   Oracura’s next-gen flossers are complemented with different types of 360-degree nozzles, a high capacity water tank, pulse mode to massage gums, tongue scrapper, and multiple setting options to modulate water pressure.   About Oracura- ORACURA is an oral care company founded in June 2014. It has gained popularity within a short span of time due to its innovative designs and patented technology. It is headquartered in Navi Mumbai, Maharashtra. The company operates facilities all over India and has a pan India presence. ]]> <![CDATA[IPA focuses on patient centricity and integrated quality management]]> https://biospectrumindia.com/news/95/15868/ipa-focuses-on-patient-centricity-and-integrated-quality-management.html https://biospectrumindia.com/news/95/15868/ipa-focuses-on-patient-centricity-and-integrated-quality-management.html Fri, 28 Feb 2020 10:55:00 +0530 Patient Centricity and Integrated Quality Management is the theme for this year’s India Pharmaceutical Forum, organized by the Indian Pharmaceutical Alliance (IPA) in Mumbai. Now in its 5th edition, the event brought together manufacturers, regulators, academia and other relevant stakeholders together facilitate discussions resulting in meaningful and actionable outcomes. Dr VG Somani, Drugs Controller General of India delivered the Keynote Address and released the IPA guidelines on Market Complaints. Dr VG Somani, Drugs Controller General of India said, “We are working to simplify regulatory framework in pharma sector in India as we believe the pharma industry should focus on simplicity to achieve efficient compliance. The key for regulation lies not in what is written, but how it is implemented. Patient centricity is vital to Indian Pharmaceutical industry and regulations should be able to enhance it than restrain.” “Indian Pharmaceutical Forum (IPF) is a pioneering initiative of IPA that lays a strong foundation for quality culture and capability building. Quality is fundamental to our industry and would help to take India to next level. This Forum is a unique platform which brings together all stakeholders comprising of Indian and global regulators, government policymakers, industry, academia to move forward the quality agenda. This year’s theme Patient Centricity and Integrated Quality Management will be pivotal for our journey on quality,” said Mr. Sudarshan Jain, Secretary-General, Indian Pharmaceutical Alliance The 2020 Forum focused on patient-centric approach to the manufacturing of quality medicines. With ten sessions spread over two days, the conference focused on some of the pressing issues in pharmaceutical industry such as Quality, Capability Building, Affordability and Patient-Centric Approach among other topics. With international and Indian stakeholders coming together to discuss pertinent issues related to quality management systems and thereof, the Forum brought together the relevant stakeholders in the Pharmaceutical industry to map a way forward for the Indian pharmaceutical industry. “Indian pharma has made considerable progress in our quality journey. Forums such as the IPF play a significant role in achieving the vision of the industry - to be the global benchmark in quality. Several eminent speakers participated in this edition of the IPF and made it an enriching experience,” said Mr. Satish Reddy, President, Indian Pharmaceutical Alliance. The CEO Panel on Patient Centricity and Integrated Quality Management by the CEO’s of Lupin, Dr. Reddy’s Laboratories, Sun Pharmaceuticals, Cadila Healthcare, and Cipla will reflect thoughts on the Indian pharmaceutical industry current standing and the path ahead. ]]> <![CDATA[Sun Pharma launches RIOMET ER oral suspension in the US]]> https://biospectrumindia.com/news/95/15864/sun-pharma-launches-riomet-er-oral-suspension-in-the-us.html https://biospectrumindia.com/news/95/15864/sun-pharma-launches-riomet-er-oral-suspension-in-the-us.html Fri, 28 Feb 2020 09:00:00 +0530 Sun Pharmaceutical Industries has announced that one of its wholly-owned subsidiaries has launched Riomet ER™ in the U.S. as an adjunct to diet and exercise to improve glycemic control in patients 10 years of age and older with type 2 diabetes mellitus. Riomet ER was approved by the U.S. Food and Drug Administration (FDA) on August 29, 2019. Riomet ER, dosed once daily, is the first and only FDA-approved liquid formulation of extended-release metformin. It can be prepped and poured, thereby eliminating the need to crush the medication. The availability of a liquid formulation addresses the needs of patients with type 2 diabetes mellitus, including residents in long-term care facilities, who often have issues swallowing solid medications. Riomet ER offers dosing flexibility and an acceptable taste. “As the fourth Sun Pharma product designed to address the needs of the 40% of U.S. adults who cannot or will not swallow solid medications, Riomet ER™ reflects our continued commitment to providing alternative formulations to underserved patient populations,” said Abhay Gandhi, CEO, North America, Sun Pharma. “Our sprinkle and liquid formulation products treat common, chronic diseases – type 2 diabetes, hypertension, elevated cholesterol, pain and depression – where adherence issues are common and can be life-threatening.” The label for Riomet ER™ carries a boxed warning about the risk of lactic acidosis with excessive alcohol intake, as alcohol increases the effect of Riomet ER™ on lactate metabolism. The label also includes a warning about the risk of vitamin B12 deficiency, as well as a warning about the risk of hypoglycemia with concomitant use with insulin and insulin secretagogues. In placebo-controlled clinical trials of Riomet ER, the most common adverse reactions (occurring in greater than 5% of participants) were diarrhea, nausea/vomiting, flatulence, asthenia, indigestion, abdominal discomfort, and headache. More than 30 million Americans, or about 1 person in 10 in the U.S., have diabetes. The vast majority of those individuals (90% to 95%) have type 2 diabetes1, which is also known as non-insulin-dependent diabetes. Although type 2 diabetes can affect people of any age, the disease occurs most often in middle-aged and older people.2 The risk of developing type 2 diabetes is increased in people who are age 45 or older, have a family history of diabetes, or are overweight or obese. ]]> <![CDATA[Dr. Reddy's Laboratories launches Delayed-Release Tablets in the U.S. Market]]> https://biospectrumindia.com/news/95/15876/dr-reddys-laboratories-launches-delayed-release-tablets-in-the-u-s-market.html https://biospectrumindia.com/news/95/15876/dr-reddys-laboratories-launches-delayed-release-tablets-in-the-u-s-market.html Fri, 28 Feb 2020 00:00:00 +0530  Dr. Reddy’s Laboratories has announced the first-to-market launch of Naproxen and Esomeprazole Magnesium Delayed-Release Tablets, a therapeutic equivalent generic version of Vimovo® (Naproxen and Esomeprazole Magnesium) Delayed-Release Tablets approved by the U.S. Food and Drug Administration (USFDA). “This launch is a testament to our core strengths in areas of research and development and intellectual property,” says Marc Kikuchi, Chief Executive Officer, North America Generics. “We are excited to be a part of forming the first generic market for Vimovo® Tablets and to provide an affordable treatment alternative for patients.” The Vimovo® (Naproxen and Esomeprazole Magnesium) Delayed-Release Tablets brand had U.S. sales of approximately $414 million MAT for the most recent twelve months ending in December 2019 according to IQVIA Health*. Dr. Reddy’s Naproxen and Esomeprazole Magnesium Delayed-Release Tablets are available in 375 mg/20 mg and 500 mg/20 mg tablets in bottle count sizes of 60. ]]> <![CDATA[Novartis launches Biome India, Asia's first digital innovation hub]]> https://biospectrumindia.com/news/95/15852/novartis-launches-biome-india-asias-first-digital-innovation-hub.html https://biospectrumindia.com/news/95/15852/novartis-launches-biome-india-asias-first-digital-innovation-hub.html Wed, 26 Feb 2020 00:00:00 +0530 Novartis announced the launch of the Novartis Biome India, a digital innovation hub aimed at boosting the connection and interaction between Novartis and partners from across the digital ecosystem, from nimble startups and academia to the biggest players in the industry. The first in Asia, the Novartis Biome India will act as a bridge to the external ecosystem, enabling Novartis teams to better discover, develop and drive collaborations that transform innovative initiatives into impactful and scalable solutions for patients. By joining this global network, the Novartis Biome India can tap into the assets and expertise of the broader Novartis portfolio to have even greater impact, including: access to anonymized data customized residency programs personalized mentoring “India has a rich and vibrant technology community. Together, we have a fantastic opportunity to combine our scientific know-how with the expertise of tech players, big and small, to create digital solutions for patients, at scale,” Bertrand Bodson, Chief Digital Officer, Novartis. “Partnerships are at the core of this effort. The Biome’s suite of end-to-end services will ensure we deliver on our commitment to both our internal teams and our collaboration partners.” “We are proud to have the first Novartis Biome in Asia being launched in India. It is testimony to our technology ecosystem. Our ambition is to use data and digital to improve and extend people’s lives. We look forward to seeing the outcome of this initiative in the near future,” Sanjay Murdeshwar, Country President, Novartis India. “We are pleased to have Biome India in Hyderabad and want to leverage this ecosystem to work with startups and innovators to disrupt healthcare in the country and perhaps the world. We will work closely with internal and external partners in pursuit of high value, potentially disruptive innovations,” said Naveen Gullapalli, Head Novartis Hyderabad ]]> <![CDATA[Novartis to develop new oral drug for visceral leishmaniasis]]> https://biospectrumindia.com/news/95/15847/novartis-to-develop-new-oral-drug-for-visceral-leishmaniasis.html https://biospectrumindia.com/news/95/15847/novartis-to-develop-new-oral-drug-for-visceral-leishmaniasis.html Tue, 25 Feb 2020 14:20:00 +0530 Novartis and the Drugs for Neglected Diseases initiative (DNDi), a not- for-profit research and development (R&D) organization, have signed a collaboration and licence agreement to jointly develop LXE408, as a potential new oral treatment for visceral leishmaniasis, one of the world’s leading parasitic killers. LXE408 is a first-in-class compound, discovered at Novartis with financial support from the Wellcome Trust. Within the scope of the agreement, Novartis is responsible for completing Phase I clinical trials. In addition, it will drive pharmaceutical development and regulatory submissions. Upon approval, Novartis has committed to distributing the drug on an affordable basis worldwide with a focus on maximizing access in endemic countries. DNDi will lead Phase II and Phase III clinical development, with the first Phase II study scheduled to start in early 2021 in India. Additional trials are planned to take place in East Africa, which has the highest burden of visceral leishmaniasis. “Existing treatments for visceral leishmaniasis are simply not good enough. They are too long increasingly ineffective, and can be toxic, painful, and costly,” said Dr Bernard Pécoul, Executive Director of DNDi. “Our hope is to radically transform this by developing new oral drugs that are affordable, safe, effective, easy to take, and can also be adapted to meet the treatment needs of patients in different countries.” Over one billion people worldwide are at risk of leishmaniasis, which is transmitted by the bite of a sand fly. Visceral leishmaniasis, also known as kala-azar, is the most serious form of leishmaniasis, causing fever, weight loss, spleen and liver enlargement, and if left untreated, death. There are an estimated 50 000 to 90 000 new cases per year. Treating the disease is complex as it is dependent on the species of infecting parasite and the country, as treatment responses differ from region toregion. “Novartis has a long-term commitment to neglected tropical diseases that spans several decades. Diseases caused by kinetoplastid parasites, such as leishmaniasis, are one of our strategic research priorities and, together with our partners, we have developed a promising portfolio of drug candidates,” said Dr Lutz Hegemann, Chief Operating Officer for Global Health at Novartis. “We are excited to collaborate with DNDi to reimagine treatment options for people with leishmaniasis around the world.” Broader partnerships The collaboration between DNDi and Novartis is aligned with a broader program with Wellcome and other partners to develop new combinations of entirely new, all-orally acting chemical entities, to treat visceral leishmaniasis and cutaneous leishmaniasis, another form of the disease. The program brings together a strong consortium of R&D partners, including the University of Dundee, GSK, Pfizer, TB Alliance, and Takeda Pharmaceutical Company Limited. These partners have built a portfolio of lead series, pre-clinical and clinical drug candidates, originating from different chemical classes with different mechanisms of action against leishmania parasites.  “We are delighted to be partnering with Novartis from drug development to delivering a promising new oral treatment for visceral leishmaniasis. Together, we can contribute to sustaining elimination efforts in India and altering the treatment landscape in East Africa,” said Dr Fabiana Alves, Head of Visceral Leishmaniasis Clinical Program at DNDi. ]]> <![CDATA[Lupin launches Ethacrynic Acid Tablets USP]]> https://biospectrumindia.com/news/95/15846/lupin-launches-ethacrynic-acid-tablets-usp.html https://biospectrumindia.com/news/95/15846/lupin-launches-ethacrynic-acid-tablets-usp.html Tue, 25 Feb 2020 14:10:00 +0530 Pharma major Lupin Limited (Lupin) announced the launch of Ethacrynic Acid Tablets USP, 25 mg, having received an approval from the United States Food and Drug Administration (U.S. FDA) earlier. The product would be manufactured at Lupin’s Nagpur OSD facility, India. Ethacrynic Acid Tablets USP, 25 mg, is the generic equivalent of Edecrin® Tablets, 25 mg, of Bausch Health Americas, Inc. and are indicated for the treatment of edema when an agent with greater diuretic potential than those commonly employed is required. • Treatment of the edema associated with congestive heart failure, cirrhosis of the liver, and renal disease, including the nephrotic syndrome.• Short-term management of ascites due to malignancy, idiopathic edema, and lymphedema.• Short-term management of hospitalized pediatric patients, other than infants, with congenital heartdisease or the nephrotic syndrome.• Intravenous ethacrynic acid sodium is indicated when a rapid onset of diuresis is desired, e.g., in acute pulmonary edema, or when gastrointestinal absorption is impaired or oral medication is not practicable. Ethacrynic Acid Tablets USP (RLD: Edecrin®) had an annual sales of approximately USD 20 million in the U.S.(IQVIA MAT December 2019). ]]> <![CDATA[Abbott unveils new four strain flu vaccine for influenza ]]> https://biospectrumindia.com/news/95/15836/abbott-unveils-new-four-strain-flu-vaccine-for-influenza-.html https://biospectrumindia.com/news/95/15836/abbott-unveils-new-four-strain-flu-vaccine-for-influenza-.html Mon, 24 Feb 2020 14:20:00 +0530 Abbott, the global healthcare company, recently launched a new inactivated quadrivalent vaccine for influenza, the first of its kind sub-unit vaccine offering protection against four virus strains, in India. It is the only 0.5 ml quadrivalent flu vaccine in India that has been approved for use in children below 3 years. In fact, it can be given to children from 6 months onwards, and to adults. A 0.5 ml vaccine could improve the immune response in children below 3 years. A globally approved product, Abbott’s vaccine offers wide protection by immunizing against four different flu virus strains simultaneously. Hence, it is called a quadrivalent or tetravalent vaccine. It includes a second B-strain of influenza virus, compared to one B-strain included in trivalent vaccines. Recommending a vaccine can be complex for the health authorities. This is because there may be a mismatch in the vaccine strain and the circulating viral strain. Therefore, the inclusion of an additional B-strain in quadrivalent vaccines can help broaden protection. As per a recently published study on this vaccine globally, in children, quadrivalent vaccines demonstrated superior immunogenicity or immune response compared with the alternate- lineage B-strains in trivalent vaccines, with comparable safety. This is the first 3rd generation, quadrivalent sub-unit flu vaccine in India. A sub-unit vaccine is the most advanced flu vaccine. The benefit of a sub-unit vaccine is that it undergoes a further step of purification as compared to split vaccines, and thus is more refined. This may lead to lesser side-effects. In clinical studies conducted globally across high-risk groups including children, the elderly, pregnant women, asthmatics and diabetics, sub-unit vaccines have shown better tolerability and a favourable safety profile compared to other flu vaccine types. An inactivated influenza vaccine is beneficial in high risk populations, since it can be given to a larger set of people, such as pregnant women, children below 2 years, older adults and immunocompromised patients. Dr. Srirupa Das, Medical Director, Abbott India said, “We are excited with the launch of the quadrivalent version of our flu vaccine, which can be offered to both children above 6 months and adults.  This particular type of vaccine provides good immune response with less side-effects. This is yet another significant step in Abbott’s endeavor to protect as many people as possible against the flu. As part of its “Mothers Against Influenza” (MAI) campaign, which recognizes the potentially serious consequences that influenza can have, Abbott is raising awareness among people on the importance of protecting families against influenza so that they may live healthier, fuller lives.” A respiratory infection that affects all ages, influenza is distinct from the common cold. An influenza infection typically results in high fever lasting for 3 to 4 days, including symptoms such as headache, myalgia or muscle pain, exhaustion and severe chest discomfort and cough. Moreover, influenza can cause serious complications in certain groups such as those with respiratory ailments, cardiac disease and diabetes, as well as young children and the elderly. Influenza A and B, the two viruses that cause human disease, are currently circulating globally and in India causing seasonal outbreaks. The disease burden of influenza is substantial, and B viruses have been estimated to be associated with 25% of all influenza related mortality. Dr. Bhaskar Shenoy, Head Department of Pediatrics & Chief, Division of Pediatric Infectious Disease, Manipal Hospital, Bangalore and Life Member, Infectious Disease Chapter, Indian Academy of Pediatrics said, “The National Center of Disease Control estimates show that influenza reported cases have increased 5-fold in India from 5,044 in 2012 to 28798 in 2019. And in Delhi, influenza reported cases have increased around 70% per annum from 151 in 2013 to 3627 reported cases in 2019. Vaccination is the best defense against influenza. What makes high vaccination rates so important is the ‘herd-immunity’ benefit. Widespread immunization of otherwise healthy populations may result in interruption of transmission of influenza and thereby may indirectly protect those in high-risk groups.  Every day, we come in contact with the elderly, parents of children and pregnant women, all of whom could be put at risk of getting the flu virus from us. Getting a flu vaccine before influenza season is advisable, not only for you and your family, but for the entire community.” Children are particularly vulnerable to influenza. One India study estimates over 16 million influenza cases occurred in 2016 in under-5-year-old patients, accounting for 10.9 million outpatient visits and 109,000 hospitalizations. Despite the proven benefits of influenza vaccination in children as well as adults and the elderly, immunization rates across all vaccine preventable diseases remain low.   ]]> <![CDATA[AstraZeneca India launches advanced treatment option for T2D]]> https://biospectrumindia.com/news/95/15821/astrazeneca-india-launches-advanced-treatment-option-for-t2d.html https://biospectrumindia.com/news/95/15821/astrazeneca-india-launches-advanced-treatment-option-for-t2d.html Fri, 21 Feb 2020 06:00:00 +0530 AstraZeneca India has announced the launch of Qtern® (Dapagliflozin 10mg + Saxagliptin 5mg film Coated Tablets) for treatment of type 2 diabetes (T2D). Qtern® is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus (T2DM). Dr Anil Kukreja, Vice President, Medical Affairs and Regulatory, AstraZeneca India commenting on the launch said, “Qtern® combines two anti-hyperglycaemic agents (SGLT-2 inhibitor and DPP-4 inhibitor) with complementary mechanisms of action in a convenient dosing option of once-daily tablet. Type-2 diabetes is a complex disease and 2 out of 3 patients remain inadequately controlled on their current glucose-lowering regimen. Qtern®, will provide an additional oral medicine option to improve blood sugar levels with significantly low risk of hypoglycaemia.” SGLT-2 inhibitors help patients achieve improved glycaemic control by reducing the reabsorption of glucose from the renal tubules of kidneys and enabling its removal via the urine. Dapagliflozin (SGLT-2 inhibitor), has already demonstrated reductions in HbA1c and has also shown additional advantages including weight reduction, blood pressure reduction and cardiac protection in type 2 diabetes patients as per research carried out for over 5 years. Similarly, Saxagliptin (DPP-4 Inhibitor) reduced blood glucose and has proven primary cardiovascular safety endpoint in cardiovascular outcome trial for anti-diabetes drug conducted in more than 16000 patients. Further, DISCOVER, a large observational study enrolling more than 3000 type 2 diabetes patients in India revealed that diabetes patients in India have high mean glycosylated hemoglobin 8.6% even after 4.5 years after treatment initiation (for well controlled diabetics HbA1c should be less than 7%). These interim study findings presented at the international congress indicate need for early treatment intensification to minimize risk of complications associated with type 2 diabetes. Qtern® can be given at any time in the day with or without food. ]]> <![CDATA[EY suggests imperative need of reinventing pharma biz]]> https://biospectrumindia.com/news/95/15811/ey-suggests-imperative-need-of-reinventing-pharma-biz.html https://biospectrumindia.com/news/95/15811/ey-suggests-imperative-need-of-reinventing-pharma-biz.html Wed, 19 Feb 2020 10:50:00 +0530 As Indian pharma companies prepare to shift from supplying commodities to supplying innovations, technology is altering the way health care is imagined and delivered, according to an EY report, “Today for tomorrow: realizing the potential of Life Sciences 4.0”, released at BioAsia 2020 in Hyderabad. The accelerated technology and scientific advancement in the Fourth Industrial Revolution, or Life Sciences 4.0, is changing the traditional model of health. The combination of smart devices and sophisticated AI-based algorithms has made it possible to remotely diagnose, monitor and treat disease, leading to a shift in health care delivery from hospitals and clinics to patients’ homes. People are now comfortable using wearables and sensors to track their health and fitness. Data generated from these devices empowers individuals to make their own health choices and fuels a shift from disease treatment to better management, and ultimately disease prevention. With the increasing focus on personalization, there is a shift from a one-size-fits-all model of care, where treatments are developed for the entire population, to tailored interventions. This is becoming the reality in the oncology and rare disease space, where individualized cell and gene therapies (ICGT) are manufactured from a patient’s own tissue. Because the delivery of ICGT treatments requires new manufacturing, delivery and information management processes, companies need to plan and ensure the entire product value chain is aligned to deliver such innovative individualized therapies at scale in the future. Sriram Shrinivasan, Global Generics and National Health and Lifesciences Leader, EY, says: “Life Sciences 4.0 is all about the ability of the life sciences companies to strategically move from one stage of business maturity to another at the right time and with the right capabilities. Indian companies may be behind their global peers, but they have the advantage of learning from global failures and successes. Executives in most of the companies understand the urgent need to embrace digital. Those that differentially invest in data-centric technologies and change management to accelerate the business impact will be best positioned to reap reward. As organizations plan their digital agendas, it is important to bridge the gap between a technology’s potential and its successful delivery. Companies need to develop an exponential mindset that leverages technology for business model reinvention and empowering the workforce.” Pamela Spence, EY Global Health Sciences and Wellness Industry Leader, says, “We are in the midst of moving from population care to personalised care. Future value in Health Care lies in how organisations can unlock the power of data to fuel innovation to deliver better personalised health outcomes. It is also access to skills rather than total ownership of skills that will become important as we see the emergence of fluid ecosystems operating across industries to deliver health benefit” ]]> <![CDATA[Novartis launches digital innovation hub in Hyderabad]]> https://biospectrumindia.com/news/95/15809/novartis-launches-digital-innovation-hub-in-hyderabad.html https://biospectrumindia.com/news/95/15809/novartis-launches-digital-innovation-hub-in-hyderabad.html Wed, 19 Feb 2020 10:30:00 +0530 Novartis has announced the launch of the Novartis Biome India, a digital innovation hub aimed at boosting the connection and interaction between Novartis and partners from across the digital ecosystem, from nimble startups and academia to the biggest players in the industry. The first in Asia, the Novartis Biome India will act as a bridge to the external ecosystem, enabling Novartis teams to better discover, develop and drive collaborations that transform innovative initiatives into impactful and scalable solutions for patients. By joining this global network, the Novartis Biome India can tap into the assets and expertise of the broader Novartis portfolio to have even greater impact, including: access to anonymized data customized residency programs personalized mentoring “India has a rich and vibrant technology community. Together, we have a fantastic opportunity to combine our scientific know-how with the expertise of tech players, big and small, to create digital solutions for patients, at scale,” Bertrand Bodson, Chief Digital Officer, Novartis. “Partnerships are at the core of this effort. The Biome’s suite of end-to-end services will ensure we deliver on our commitment to both our internal teams and our collaboration partners.” “We are proud to have the first Novartis Biome in Asia being launched in India. It is testimony to our technology ecosystem. Our ambition is to use data and digital to improve and extend people’s lives. We look forward to seeing the outcome of this initiative in the near future,” Sanjay Murdeshwar, Country President, Novartis India. “We are pleased to have Biome India in Hyderabad and want to leverage this ecosystem to work with startups and innovators to disrupt healthcare in the country and perhaps the world. We will work closely with internal and external partners in pursuit of high value, potentially disruptive innovations,” said Naveen Gullapalli, Head Novartis Hyderabad.   ]]> <![CDATA[K T Rama Rao inaugurates BE’s plant at genome valley & unveils typhoid conjugate vaccine]]> https://biospectrumindia.com/news/95/15805/k-t-rama-rao-inaugurates-bes-plant-at-genome-valley-unveils-typhoid-conjugate-vaccine.html https://biospectrumindia.com/news/95/15805/k-t-rama-rao-inaugurates-bes-plant-at-genome-valley-unveils-typhoid-conjugate-vaccine.html Tue, 18 Feb 2020 12:35:00 +0530 Mr. K T Rama Rao, Honourable Minister for Information Technology, Industries & Commerce, Municipal Administration and Urban Development, Government of Telangana, inaugurated  Biological E. Limited’s (BE) Plant and unveiled its new Typhoid Conjugate Vaccine (TCV) today  in the Special Economic Zone at Genome Valley in Kolthur Village on the outskirts of Hyderabad.    Addressing the gathering, IT and Industries Minister Mr. K T Rama Rao appreciated the expansion initiatives of Biological E. Limited and said: “We are committed to making the State of Telangana number one State in terms of industrial growth and employment generation with a special focus on life sciences. In fact, these growth engines will not only boost the economy of the State but also improve the livelihood of people, who depend directly or indirectly on these industries. We are happy to see that this massive state-of-the-art plant, the foundation stone for which was laid during BioAsia 2017, is getting inaugurated during this 17th edition of BioAsia today.’’ Welcoming the gathering, Ms. Mahima Datla, Managing Director, Biological E. Limited, thanked the honourable Minister for inaugurating the plant and unveiling the vaccine. Ms. Mahima said: ``BE has invested around Rs.300 crore for building this plant, which is now ready for commercial production, on about 29 acres of land. This Plant would generate employment opportunities for around 1000 people. This new facility will help our existing Vaccines Plant enhance the production and manufacture new products, which are in the pipeline.’’   Recently, BE received the authorisation from the health regulatory authorities of India to license and market a new Typhoid Conjugate Vaccine. The approval from the Central Drugs Standard Control Organisation (CDSCO) is based on a thorough assessment of the vaccine’s efficacy and safety profile.. TCV is an injectable single-dose vaccine to be administered to children from 6 months old as well as adults and it contains Vi Polysaccharide derived from C. Freundii conjugated to CRM197 protein. The clinical studies conducted in India demonstrated that the safety and immunogenicity profiles of this vaccine are comparable to the other licensed and WHO Pre-qualified Typhoid conjugate vaccine. This vaccine was developed in partnership with the GSK Vaccines Institute for Global Health, based in Siena (Italy), which first developed the asset and transferred it to BE in 2013. Subsequent developmental work on the vaccine was done by BE, including manufacturing process optimization and scale up, pre-clinical studies and full clinical trials in India. This vaccine will be manufactured in BE’s GMP manufacturing facilities in Hyderabad, India and could be commercially available within 3 months. With this authorization from CDSCO the vaccine is now approved to be marketed in India, and it also allows BE to submit the vaccine for WHO pre-qualification (PQ) and registration in several other countries. This will help to expand its current portfolio of seven WHO PQ vaccines. Ms. Mahima Datla, Managing Director, Biological E. Limited, commented on the development: “We are happy that our joint efforts have successfully produced a promising Typhoid vaccine. This is a remarkable milestone in our collaborative journey with the GSK Vaccine Institute for Global Health to save the maximum number of people, particularly children, around the world from Typhoid, which is a deadly, yet vaccine preventable disease.” Dr Thomas Breuer, Chief Medical Officer of GSK Vaccines, commented: “Having this new vaccine approved is an important milestone for Global Health. It shows that GSK’s innovative and sustainable partnership model works to deliver vaccines based on GSK latest science to help protect people in developing countries against major health threats. We are very pleased with the excellent and close collaboration with BE.” Upon pre-qualification by WHO, which is anticipated in 2020, this new vaccine is anticipated to significantly contribute to the unmet public health need in developing countries by helping protect children against typhoid fever and by contributing to securing the supply typhoid vaccines. ]]> <![CDATA[Industry sees no shortage of drugs and medicines in India]]> https://biospectrumindia.com/news/95/15801/industry-sees-no-shortage-of-drugs-and-medicines-in-india.html https://biospectrumindia.com/news/95/15801/industry-sees-no-shortage-of-drugs-and-medicines-in-india.html Tue, 18 Feb 2020 10:25:00 +0530 Keeping in view the country’s over dependence on import of Active Pharmaceutical Ingredients (APIs), Government of India has constituted a Task Force on APIs under the chairmanship of Mansukh Mandaviya, Minister of State for Shipping (I/C) and Chemicals & Fertilizers to formulate a road map for the enhanced production of APIs in the country.            The 5th Meeting of the Task Force was recently held where several important issues were discussed regarding policy relaxations to small, medium and large API units and also simplification of the process for environment clearance for production and availability of medicines. In the meeting, Mansukh Mandaviya took stock of the situation of availability of drugs and medicines. The Industry Representatives has explained thoroughly to Shri Mansukh Mandaviya that they have enough drugs and medicines to deal with any contingency arising out of impact of CoronaVirus. They ensured that there will be no shortage of any Drugs, APIs and Medicines in the coming days in India. During the meeting, the challenges faced by the Pharmaceutical Industry in obtaining Environment Clearance were also discussed. The representative of Ministry of Environment and Forest, Climate Change (MoEF&CC) has stated that steps are being taken to expedite Environment Clearances and also mentioned that recently MoEF&CC has modified the guidelines so that there is no need to obtain separate Environment Clearance, if the production of the Pharma unit is increased by 50%.   ]]> <![CDATA[Biological E unveils new typhoid conjugate vaccine]]> https://biospectrumindia.com/news/95/15800/biological-e-unveils-new-typhoid-conjugate-vaccine.html https://biospectrumindia.com/news/95/15800/biological-e-unveils-new-typhoid-conjugate-vaccine.html Mon, 17 Feb 2020 18:10:00 +0530 K T Rama Rao, Minister for Information Technology, Industries & Commerce, Municipal Administration and Urban Development, Government of Telangana, inaugurated  Biological E. Limited’s (BE) Plant and unveiled its new Typhoid Conjugate Vaccine (TCV)  in the Special Economic Zone at Genome Valley in Kolthur Village on the outskirts of Hyderabad.    Addressing the gathering, IT and Industries Minister K T Rama Rao appreciated the expansion initiatives of Biological E. Limited and said: “We are committed to making the State of Telangana number one State in terms of industrial growth and employment generation with a special focus on life sciences. In fact, these growth engines will not only boost the economy of the State but also improve the livelihood of people, who depend directly or indirectly on these industries. We are happy to see that this massive state-of-the-art plant, the foundation stone for which was laid during BioAsia 2017, is getting inaugurated during this 17th edition of BioAsia.’’ Welcoming the gathering, Mahima Datla, Managing Director, Biological E. Limited, thanked the honourable Minister for inaugurating the plant and unveiling the vaccine. Mahima said: ``BE has invested around Rs.300 crore for building this plant, which is now ready for commercial production, on about 29 acres of land. This Plant would generate employment opportunities for around 1000 people. This new facility will help our existing Vaccines Plant enhance the production and manufacture new products, which are in the pipeline.’’   Recently, BE received the authorisation from the health regulatory authorities of India to license and market a new Typhoid Conjugate Vaccine. The approval from the Central Drugs Standard Control Organisation (CDSCO) is based on a thorough assessment of the vaccine’s efficacy and safety profile.. TCV is an injectable single-dose vaccine to be administered to children from 6 months old as well as adults and it contains Vi Polysaccharide derived from C. Freundii conjugated to CRM197 protein. The clinical studies conducted in India demonstrated that the safety and immunogenicity profiles of this vaccine are comparable to the other licensed and WHO Pre-qualified Typhoid conjugate vaccine. This vaccine was developed in partnership with the GSK Vaccines Institute for Global Health, based in Siena (Italy), which first developed the asset and transferred it to BE in 2013. Subsequent developmental work on the vaccine was done by BE, including manufacturing process optimization and scale up, pre-clinical studies and full clinical trials in India. This vaccine will be manufactured in BE’s GMP manufacturing facilities in Hyderabad, India and could be commercially available within 3 months. With this authorization from CDSCO the vaccine is now approved to be marketed in India, and it also allows BE to submit the vaccine for WHO pre-qualification (PQ) and registration in several other countries. This will help to expand its current portfolio of seven WHO PQ vaccines. Mahima Datla, Managing Director, Biological E. Limited, commented on the development: “We are happy that our joint efforts have successfully produced a promising Typhoid vaccine. This is a remarkable milestone in our collaborative journey with the GSK Vaccine Institute for Global Health to save the maximum number of people, particularly children, around the world from Typhoid, which is a deadly, yet vaccine preventable disease.” Dr Thomas Breuer, Chief Medical Officer of GSK Vaccines, commented: “Having this new vaccine approved is an important milestone for Global Health. It shows that GSK’s innovative and sustainable partnership model works to deliver vaccines based on GSK latest science to help protect people in developing countries against major health threats. We are very pleased with the excellent and close collaboration with BE.” Upon pre-qualification by WHO, which is anticipated in 2020, this new vaccine is anticipated to significantly contribute to the unmet public health need in developing countries by helping protect children against typhoid fever and by contributing to securing the supply typhoid vaccines.   Photo Caption : Left to Right Mahima Datla, Managing Director, Biological E Limited, Kiran Mazumdar-Shaw, KT Rama Rao, Minister for IT, MA&UD, Govt. of Telangana, Prof. Baron Peter Piot, Director,  London School of Hygiene & Tropical Medicine, And Jayesh Ranjan. ]]> <![CDATA[IPA to host 5th India Pharmaceutical Forum ]]> https://biospectrumindia.com/news/95/15794/ipa-to-host-5th-india-pharmaceutical-forum-.html https://biospectrumindia.com/news/95/15794/ipa-to-host-5th-india-pharmaceutical-forum-.html Mon, 17 Feb 2020 00:00:00 +0530 Patient Centricity and Integrated Quality Management is the theme for this year’s India Pharmaceutical Forum, organized by the Indian Pharmaceutical Alliance (IPA) to be held in Mumbai from February 27-28. Now in its 5th edition, the event will bring manufacturers, regulators, academia and other relevant stakeholders together facilitate discussions resulting in meaningful and actionable outcomes. Dr P D Vaghela, Secretary, Department of Pharmaceuticals, Government of India will deliver the Keynote Address and release the IPA guidelines on Market Complaints. An update on the Center for Drug Evaluation and Regulation (CDER) and recent Cross-Contamination Case Studies will be presented by Dr. Francis Godwin, Director, Office of Manufacturing Quality (OMQ), Office of Compliance (OC), USFDA. Dr. Samantha Atkinson, Director of Inspection, Enforcement and Standards (IE & S), Medicines and Healthcare Products Regulatory Agency (MHRA), will helm a session on Culture Transformation Best Practices, along with Ms Susan Schniepp, Chair-elect, Parenteral Drug Association (PDA) and Mr Johnny Mikell, President, Global Quality, Lupin. “We are in the midst of a patient-centred care revolution in healthcare. The 5th India Pharmaceutical Forum provides an apt opportunity for industry, regulators and other players to engage in discussions on patient centricity and quality management systems. At the same time, the forum will provide a platform to pharma and healthcare professionals to reflect on the journey so far in terms of Quality” said Mr Sudarshan Jain, Secretary-General, IPA. “India is the pharmacy of the world and accounts of approximately 20 per cent of market share globally in volume terms and IPA is committed to providing quality medicines to its consumers across the globe. For us patient safety and health is paramount,” he added. The 5th India Pharmaceutical Forum has ten sessions addressing various aspects of drug manufacturing such as Quality, Capability Building, Affordability and Patient-Centric Approach among other topics. The Forum will culminate with a Panel Discussion on Patient Centricity and Integrated Quality Management which will bring together the CEOs of top Indian Pharma companies such as Lupin, Dr. Reddy’s, Sun Pharma, Cadila and Cipla among others on one platform to discuss a way forward for the Industry. ]]> <![CDATA[Zydus to develop vaccine against COVID-19]]> https://biospectrumindia.com/news/95/15795/zydus-to-develop-vaccine-against-covid-19.html https://biospectrumindia.com/news/95/15795/zydus-to-develop-vaccine-against-covid-19.html Mon, 17 Feb 2020 00:00:00 +0530 Zydus Cadila, an innovation-driven, global pharmaceutical company, announced that it has initiated an accelerated research programme with multiple teams in India and Europe developing a vaccine for the novel coronavirus, 2019-nCoV (COVID-19) based on two approaches. The first approach deals with the development of a DNA vaccine against the major viral membrane protein responsible for the cell entry of the novel coronavirus, now called COVID19. The second approach deals with the development of a live attenuated recombinant measles virus vectored vaccine against COVID-19. Speaking on the development, Chairman of the Zydus Group, Mr. Pankaj R. Patel said, “There is an urgent and pressing need to develop a safe and efficacious vaccine that can prevent the spread of this deadly virus. Our researchers are working to bring a speedy solution to this most devastating outbreak in recent times.” The group’s Vaccine Technology Centre in India which is working on the plasmid DNA vaccine also has wide ranging capabilities in developing and manufacturing different vaccines for unmet needs. The group was the first to develop and indigenously manufacture the vaccine to combat Swine Flu during outbreak in 2010. The group’s research arm in Europe, Etna Biotech is working on measles reverse genetics technology which has been used earlier to successfully develop the SARS-vaccine. The vaccines developed through this platform are safe, efficacious and large doses can be manufactured for which Zydus already has production facilities in place. The company’s robust manufacturing facilities for producing recombinant antigens and measles containing vaccines would enable rapid ramping up of the production for both vaccine candidates, once the proof-of-concept is established. ]]> <![CDATA[Codagenix, Serum Institute to co-develop vaccine against COVID-19]]> https://biospectrumindia.com/news/95/15784/codagenix-serum-institute-to-co-develop-vaccine-against-covid-19.html https://biospectrumindia.com/news/95/15784/codagenix-serum-institute-to-co-develop-vaccine-against-covid-19.html Fri, 14 Feb 2020 10:55:00 +0530 Codagenix, Inc., a clinical-stage biotechnology company developing prophylactic vaccines and oncolytic virus therapies has announced a collaboration with the Serum Institute of India to rapidly co-develop a live-attenuated vaccine against the emergent coronavirus. There are no licensed vaccines or therapeutics for this novel coronavirus, now referred to as COVID-19. A live-attenuated vaccine has multiple advantages, including mounting an immune response to multiple antigens of the virus and the ability to scale for mass production. Codagenix uses viral deoptimization to synthesize "rationally designed," live-attenuated vaccines. Company’s technology allows for the rapid generation of multiple vaccine candidates against emerging viruses, starting with only the digital sequence of the viral genome. Thanks to major advances in the speed and quality of genome sequencing in recent years, in addition to open-source data sharing among scientists and public health agencies around the world, the nCoV genome was available to the public in a matter of days after the virus was first isolated. Thanks to the availability of this data, Codagenix has already designed multiple nCoV vaccine candidate genomes using its proprietary deoptimization technology. The vaccine viruses will then be grown and tested in vivo by contracted laboratories suitable for containment, prior to testing in clinical trials. The Serum Institute of India, a vaccine manufacturer and distributor with a global footprint, will then scale-up the manufacture of the vaccine to ensure its availability to meet a critical public health need. Codagenix and Serum Institute are pursuing an accelerated development pathway with built-in redundancies to increase speed and likelihood of success. Dr. Adar Poonwalla, the CEO of Serum Institute, commented, "We are very excited for this new partnership with Codagenix and we hope that we can establish a platform dealing with new infectious diseases and outbreaks beginning with the coronavirus epidemic." Robert Coleman, CEO of Codagenix said, "We are honored to form a collaboration with the Serum Institute, one of the world's leading vaccine manufacturers. With the Serum Institute's financial and technical support, we will be able to push a coronavirus vaccine into the clinic on an extremely rapid timeline. Live-attenuated vaccines like the ones developed by Codagenix are ideally suited to outbreak scenarios as they scale rapidly and generally require only modest amounts of active ingredient for each immunization, as compared to inactivated and subunit vaccines. We are proud to be confronting this public health crisis head-on.” Glenn Rockman, of Adjuvant Capital, added: "One of the many compelling features of the Codagenix technology is the theoretical ability to rapidly respond to emerging viral threats. We never imagined the Codagenix platform would be tested by a possible pandemic so soon after we invested, but we are nonetheless grateful for the opportunity to contribute to the global nCoV response. The Codagenix team has been working around the clock with our new colleagues at the Serum Institute of India, and both companies are eager to manufacture and test these new vaccine candidates as quickly as possible." The newly identified coronavirus causes mild to severe respiratory illness, with symptoms including cough and fever. Until an effective vaccine becomes available, transmission of the virus can be prevented by frequent handwashing and avoiding close contact with people who are sick.   ]]> <![CDATA[Vildagliptin’s affordability to offer competitive advantage to Eris and Cipla, says GlobalData]]> https://biospectrumindia.com/news/95/15758/vildagliptins-affordability-to-offer-competitive-advantage-to-eris-and-cipla-says-globaldata.html https://biospectrumindia.com/news/95/15758/vildagliptins-affordability-to-offer-competitive-advantage-to-eris-and-cipla-says-globaldata.html Tue, 11 Feb 2020 16:05:00 +0530 Novartis has recently sold its anti-diabetic drug vildagliptin (branded as Zomelis, Vysov and Vysov M) to Ahmedabad-based Eris Lifesciences and Mumbai-based pharmaceutical major Cipla Ltd, in India. The orally active, potent and selective dipeptidyl peptidase -4 (DPP-4) inhibitor’s patent has expired in India leading to increased affordability of vildagliptin. Product acquisition and increased affordability of vildagliptin will provide a competitive advantage to both the companies in a market crowded with several players, says GlobalData, a leading data and analytics company. According to GlobalData’s upcoming report, ‘Type 2 Diabetes – Global Drug Forecast and Market Analysis to 2028’, the Indian type 2 diabetes (T2D) market, similar to other major markets, is mature and crowded with both expensive branded therapies and inexpensive generics. With an estimated diagnosed prevalent T2D population of about 90 million by 2028, approximately 80% of which are treated using anti-diabetics, India has a burgeoning T2D market with a robust and competitive pipeline. The main drivers of market growth will be the dramatic increase in disease prevalence, and physicians' efforts to delay disease progression and reduce the costly burden of diabetic complications through the use of combination therapies and novel branded drugs. Prashant Khadayate, Pharma Analyst at GlobalData, says: “The Indian diabetes market is highly competitive and price sensitive. Companies are always on the lookout for ways to differentiate themselves in this crowded market. Vildagliptin has shown good traction in the Indian market and patent expiry of vildaglitpin in the Indian market will increase the affordability and will lead to easier access.” Earlier, Zomelis was sold in India by Abbott under a license from Novartis. On the other hand, Cipla was co-marketing vildagliptin in agreement with Novartis under brand names Vysov and Vysov M (vildagliptin and metformin). As per Q2 FY’20 results, Eris Lifesciences was ranked third in terms of the number of prescriptions within the Indian diabetology segment. In FY’19, the company’s overall leading brand Glimisave (glimepiride) generated sales of INR2,212m (US $32.5m*). Tendia (tenegliptin) and Cyblex (gliclazide) are the other leading diabetic brands of Eris Lifesciences which generated sales of INR598m (US$8.8m*) and INR396m (US$5.8m*), respectively. In contrast, Cipla views diabetes as a main therapeutic area of focus, due to the large market opportunity in India. In the past, the company has collaborated with Eli Lilly to market and distribute Basaglar (insulin glargine), with Janssen to market canagliflozin under brand name Prominad and with Mannkind USA to market inhaled insulin Afrezza, which is in clinical development. Cipla will be responsible to get the regulatory approval for Afrezza in India. Khadayate concludes: “Eris Lifesciences has already emerged as one of the key players in the diabetes market through its leading brands. Sales from its diabetes portfolio makes up approximately 25% of total company sales, as witnessed in FY’19, whereas Cipla’s diabetes portfolio accounted for only 2% of total company sales in FY’18-19. However, both companies continue to be committed to bringing effective and life-changing anti-diabetic drugs to an ever-growing diabetic population in India.  in India and innovator vildagliptin brands acquisition will provide a competitive edge over the vildagliptin generics.” ]]> <![CDATA[Sun Pharma launches campaign for awareness on acne]]> https://biospectrumindia.com/news/95/15753/sun-pharma-launches-campaign-for-awareness-on-acne.html https://biospectrumindia.com/news/95/15753/sun-pharma-launches-campaign-for-awareness-on-acne.html Tue, 11 Feb 2020 11:00:00 +0530 Sun Dermatology, a division of Sun Pharmaceutical Industries, Inc., USA, which is a wholly owned subsidiary of Sun Pharmaceutical Industries Ltd., announced the launch of Take on Acne – a new advertising campaign designed to raise awareness of the profound impact of acne on everyday life, particularly among teenagers and young adults (roughly 12-25 years of age). A common condition, acne affects more than 85% of adolescents and, depending on its severity, persistence and other factors, is highly correlated with psychosocial problems and low self-esteem. The ad concept is the result of research Sun Pharma conducted to understand how acne impacts teens and young adults, and how they experience this condition in their own words. The research uncovered common themes through personal expressions of psychosocial angst, hopelessness, and isolation. Research participants reported viewing themselves through a distorted lens, as if defined by their condition, and admitted to self-retreating to avoid being judged. “Take on Acne is meant to empower people with acne to re-gain control as their lives are interrupted by breakouts that can feel uncontrolled and overwhelming,” said Andy Nelson, Vice President, Sales and Marketing, Medical Dermatology, Sun Pharma. “By showing what adolescents with acne are going through, our aim is to give rise to the voice of the patient in a meaningful way, underscoring our commitment to these patients and the dermatology professionals who serve them.” ]]> <![CDATA[Cipla signs agreement for anti-psychotic drug]]> https://biospectrumindia.com/news/95/15748/cipla-signs-agreement-for-anti-psychotic-drug.html https://biospectrumindia.com/news/95/15748/cipla-signs-agreement-for-anti-psychotic-drug.html Tue, 11 Feb 2020 09:50:00 +0530 As part of its quest to provide access to life-saving medication and making a difference in the lives of patients, Cipla Medpro South Africa (Pty) Limited (“Cipla Medpro”), wholly-owned subsidiary of Cipla Limited, India (“Cipla”) and South Africa’s third largest pharmaceutical company in the private sector, has recently concluded an exclusive agreement (the “Agreement”) securing originator and authorised generic brands of an atypical anti-psychotic drug, Quetiapine (the “Medicine”).  The agreement involves AstraZeneca Pharmaceuticals (Pty) Limited, the originator of the Medicine, and Luye Pharma Hong Kong Limited, which acquired the assets and rights to the medicine in select territories. The transaction allows Cipla Medpro to market and distribute the Medicine in South Africa and neighbouring countries.  The existing portfolio consists of the originator brand Seroquel® and the authorised generic brand Truvalin®, medication which is used to treat mental health conditions such as schizophrenia, bipolar disorder, and major depressive disorder. Paul Miller, CEO of Cipla South Africa, said the agreement strategically enhances Cipla’s Central Nervous System (CNS) portfolio: “We want people to live a long and healthy life and have invested significantly in public awareness campaigns to educate people about the importance of mental health and the fact that there is help and hope. This transaction will help ensure that people have access to affordable and quality medicine that will help improve quality of life for people living with these conditions.” “This partnership amplifies Cipla’s growing intent to partner with innovator companies and this is a further demonstration of our core competence in building and growing originator brands, ably strengthened by strong corporate governance and quality mindset,” said Miller. ]]> <![CDATA[Lupin receives approval for Leflunomide Tablets ]]> https://biospectrumindia.com/news/95/15727/lupin-receives-approval-for-leflunomide-tablets-.html https://biospectrumindia.com/news/95/15727/lupin-receives-approval-for-leflunomide-tablets-.html Wed, 05 Feb 2020 17:35:00 +0530 Lupin Limited has announced the approval for its Leflunomide Tablets USP, 10 mg and 20 mg, from the United States Food and Drug Administration, to market a generic equivalent of Arava® Tablets, 10 mg and 20 mg, of Sanofi Aventis. The product would be manufactured at Lupin’s Pithampur (Unit 1) facility, India.  Leflunomide Tablets USP, 10 mg and 20 mg, are indicated for the treatment of adults with active rheumatoid arthritis (RA).   Leflunomide Tablets USP (RLD: Arava® Tablets) had an annual sales of approximately USD 44 million in the U.S.  (IQVIA MAT December 2019). ]]> <![CDATA[Sun Pharma launches drug for acne treatment in US]]> https://biospectrumindia.com/news/95/15720/sun-pharma-launches-drug-for-acne-treatment-in-us.html https://biospectrumindia.com/news/95/15720/sun-pharma-launches-drug-for-acne-treatment-in-us.html Wed, 05 Feb 2020 10:30:00 +0530 Sun Pharmaceutical Industries Ltd. has announced that one of its wholly owned subsidiaries has launched ABSORICA LD™ (isotretinoin) capsules in U.S. for the management of severe recalcitrant nodular acne in patients 12 years of age and older. ABSORICA LD is the only isotretinoin formulation to feature Sun Pharma’s micronization technology, which utilizes micronized particles to optimize absorption at a 20% lower dose. ABSORICA LD can be taken with or without food. “The launch of ABSORICA LD – which offers the proven efficacy and safety of ABSORICA® at a lower dose – underscores our commitment to making a difference in the lives of people with severe recalcitrant nodular acne,” said Abhay Gandhi, CEO, North America, Sun Pharma. “Severe recalcitrant nodular acne is characterized by nodules, which are hard, solid, painful lumps in the skin, and primarily affects teens and young adults,” noted Nicholas Squittieri, MD, Chief Medical Officer, North America, Sun Pharma. “Ineffective acne treatment can cause lifelong physical scars as well as psychosocial issues such as feelings of isolation. ABSORICA LD makes visibly clearer skin possible within just five months, removes the uncertainty surrounding timing of dosing, and makes absorption more predictable. The availability of a low-dose, highly bioavailable oral isotretinoin option should be welcome news for those suffering from this very severe form of acne.” ]]> <![CDATA[PerkinElmer unveils Advanced Drug Discovery and Disease Research Solutions]]> https://biospectrumindia.com/news/95/15728/perkinelmer-unveils-advanced-drug-discovery-and-disease-research-solutions.html https://biospectrumindia.com/news/95/15728/perkinelmer-unveils-advanced-drug-discovery-and-disease-research-solutions.html Wed, 05 Feb 2020 00:00:00 +0530 PerkinElmer, Inc., a global leader committed to innovating for a healthier world,  introduced new workstations and a high content screening system at SLAS2020 International Conference and Exhibition, being held on January 27–29, at Booth #929 at the San Diego Convention Center, San Diego, California. These technologies automate workflows so that disease research and drug discovery professionals can improve productivity, increase reproducibility, and garner key insights. PerkinElmer highlights these new systems, along with several key offerings from its comprehensive portfolio of instruments and reagents at SLAS2020:   JANUS® G3 Blood iQ™ Workstation: for biobanking workflows, it offers front end reformatting of plasma and buffy coat layers from centrifuged blood tubes, enabling highly reproducible, downstream genetic analysis. Sciclone® G3 NGSx HT Workstation: helps simplify the miniaturization of NGS library prep. Coupled with a new NEXTFLEX® Rapid XP DNA-seq kit, this library preparation workflow is designed to enable researchers to increase their NGS throughput while decreasing their cost per reaction. Opera Phenix® Plus High Content Screening System: for fast response analysis of physiologically relevant model systems, this enhancement to PerkinElmer’s high content imaging platform adds fast frame rate image capture for assays such as cardiomyocyte beat rate monitoring. It also offers an optional liquid handling module to enable assays like Ca2+ flux, important to the study of neurological diseases such as Alzheimer’s, Huntington’s and Parkinson’s. Designed to drive more relevant testing earlier in the drug discovery process, the Opera Phenix Plus system can also be used with two cell cultures, primary cells, 3D organoids, spheroids and microtissues. PerkinElmer is showcasing additional technologies that enable disease research and life sciences: LabChip® GX Touch™ Nucleic Acid Analyzer; explorer™ G3 Integrated Workstations; MuviCyte™ Live-Cell Imaging Kit; VICTOR® Nivo™ Multimode Microplate Reader; EnVision® Multimode Plate Reader; and EnSight™ Multimode Plate Reader. SLAS attendees learn about PerkinElmer’s industry-leading no-wash assay technologies including the Alpha, LANCE® Ultra™ and HTRF® assays.  The Alpha CETSA® assays combine PerkinElmer’s Alpha and Pelago Biosciences' Cellular Thermal Shift assays (CETSA®), which enable the assessment of target engagement in cell-based assays and generate more physiologically-relevant results. These products are for research use only. Not for use in diagnostic procedures.  “Advancing disease research and bringing new drugs to market quickly is often supported by innovative testing and analysis solutions that deliver fast, more accurate and reproducible results and novel insights,” said Alan Fletcher, VP/GM, Life Sciences at PerkinElmer. “These new offerings will help scientists and technicians meet key needs across critical lab workflows as they leverage our robust portfolio, spanning from instruments and software, plate readers and integrated workstations, to assays, reagents and services.”   PerkinElmer’s experts delivered the following presentations at SLAS2020: “The Importance of Sample Management in Precision Medicine: A High-Throughput Biobanking Workflow Solution”, “An Automated Deep-Learning Workflow for Analyzing HCS Screens”, “Technical and Workflow Considerations for cfDNA Applications”, “Taking the Guesswork Out of NGS Library Prep Reaction Miniaturization” ]]> <![CDATA[Zydus receives approval from DCGI for diabetes drug]]> https://biospectrumindia.com/news/95/15710/zydus-receives-approval-from-dcgi-for-diabetes-drug.html https://biospectrumindia.com/news/95/15710/zydus-receives-approval-from-dcgi-for-diabetes-drug.html Tue, 04 Feb 2020 11:00:00 +0530 Zydus Cadila, an innovation-driven, global pharmaceutical company, announced that it has received the approval from the Drug Controller General of India (DCGI) for use of Saroglitazar Mg in the treatment of Type II Diabetes Mellitus as an add on therapy with Metformin. The drug was previously approved in the year 2013 for the treatment of Hypertriglyceridemia and Diabetic Dyslipidemia in India. More than 1 Million patients are being treated with Lipaglyn. The Diabetes Phase 3 clinical trial was a Multi-centric, Prospective, Randomized, Double- blind Study to Evaluate the Safety and Efficacy of Saroglitazar Mg 2 mg and 4 mg as compared to Pioglitazone 30 mg in patients with type 2 diabetes. The Phase 3 trial conducted in 1140 type 2 diabetes patients for a total of 56 weeks met the primary end-points (CTRI/2015/09/006203). The primary outcome measure was the change from baseline in glycosylated hemoglobin (HbA1c) for Saroglitazar 4 mg, 2 mg and Pioglitazone 30 mg at 24 weeks. The secondary outcome measures included the change from baseline in fasting plasma glucose, 2 hour postprandial plasma glucose, lipid profile, Triglyceride (TG) cholesterol, Low density lipoprotein (LDL) cholesterol, Very low density lipoprotein (VLDL) cholesterol, High density lipoprotein (LDL) cholesterol, Total cholesterol (TC) cholesterol, Non HDL cholesterol, Apolipoprotein (Apo) A1 and Apo B between Saroglitazar (4 mg, 2 mg) and Pioglitazone (30 mg) treatment at Week 12, 24 and 56. In Phase III diabetes trial, at 24 weeks, HbA1c was reduced by 1.38 g/dL with Saroglitazar 2 mg, 1.47 g/dL with Saroglitazar 4 mg and 1.41 g/dL with Pioglitazone 30 mg. At 56 weeks, HbA1c reduced by 1.34 g/dL with Saroglitazar 2 mg, 1.49 g/dL with Saroglitazar 4 mg and 1.47 g/dL with Pioglitazone 30 mg. Saroglitazar did not cause hypoglycemia or weight gain in this trial. Lipalgyn™ was first launched in India during September 2013. Over the last several years, more than 1 Million patients have been treated with Lipaglyn™ in India for management of Hypertriglyceridemia and Diabetic Dyslipidemia, and data has been presented at several scientific and medical conferences ]]> <![CDATA[Roche Diabetes Care opens new warehouse in Mumbai]]> https://biospectrumindia.com/news/95/15707/roche-diabetes-care-opens-new-warehouse-in-mumbai.html https://biospectrumindia.com/news/95/15707/roche-diabetes-care-opens-new-warehouse-in-mumbai.html Tue, 04 Feb 2020 06:25:00 +0530 Roche Diabetes Care (RDC) India has announced the inauguration of its new warehouse in Mumbai, Maharashtra. This new warehouse will help optimise the RDC India’s warehousing footprint to enable and support its new business strategy. The warehouse meets with Roche global quality standards making it one of the best in class. It is fitted with a temperature-controlled HVAC system and state of the art material handling equipment (MHEs). Fully complying with Roche standards of safety, the warehouse is enabled to detect fire between eight to nine seconds (before visible to the human eye) and comes equipped with fire protection systems of Very Early Smoke Detection Apparatus (VESDP system), laser-based smoke detectors, fire hydrant system and top sprinklers. “At RDC India we are gearing up for a transformation to change the way people manage their diabetes by designing innovative integrated personalised diabetes management solutions. To make these solutions easily accessible to all we are in the process of optimising our distribution footprint such that it gives us improved agility. This new warehouse in the west region will enable us to cater to our current & future business requirements.” says Omar Sherief Mohammad, General Manager, Roche Diabetes Care, India. With this, Roche Diabetes Care India now has a total of four warehouses in India which are compliant with Roche global standards and is fully prepared to cater to the projected increase in volume over the next five years.   ]]> <![CDATA[Bayer Zydus launches app to manage endometriosis]]> https://biospectrumindia.com/news/95/15693/bayer-zydus-launches-app-to-manage-endometriosis.html https://biospectrumindia.com/news/95/15693/bayer-zydus-launches-app-to-manage-endometriosis.html Mon, 03 Feb 2020 07:20:00 +0530 In India, where women’s health remains a primary concern, access to credible and reliable information is often limited. Women in India suffer from several diseases that go unnoticed & undiagnosed due to lack of awareness. As a global leader in women’s health, Bayer believes that with the assistance of digital tools in the healthcare space, more women can be empowered to take ownership and manage their health and well-being on a more personalized level than ever before. To address these unmet needs, Bayer Zydus Pharma has launched ‘Bare Your Pain’, an application to help women better manage their endometriosis, as well as ‘Ask Tanu’, chatbot, which is the first of its kind in India to provide a reliable resource for advice on contraception and reproductive health.   The ‘Bare Your Pain’ application targets a chronic and painful disease like endometriosis, which are known to affect ten per cent of women of childbearing age. About 176 million women suffer from it globally, and of these 26 million women belong to India alone. The application will enable endometriosis patients to better manage and monitor this chronic health condition. For many women in India, visiting the doctor for regular health check-ups is not a priority. This app would help empower women with the information to manage their disease at home, and also monitor the progression, which would, in turn, help them have better discussions and outcomes whenever they visit the doctor.  “Disease management plays a very important role in Endometriosis. The condition can be managed well when the patient is better aware and is able to monitor the symptoms. In many cases, the patients are unable to provide a clear description of their present condition. Digital interventions in healthcare like the Bare Your Pain application will advance awareness levels and allow us to provide a better quality of life to patients,” said Dr. Narendra Malhotra, well - known Gynecologist and Obstetrician practising in Agra. With half of the country’s population younger than 25 years of age, there is also a need to raise awareness on the use of contraception among the youth, and better family planning amongst young couples. Women often shy away from these conversations due to fear of being judged. ‘Ask Tanu’ chatbot aims to address misinformation on contraception, reproductive & sexual health, by offering key information and resources on reproductive health in the convenience of a smartphone via the Facebook Messenger app, in a safe and private setting. “According to the NFHS 4 survey, 47% of the married women between 15-49 years did not use any method of family planning[iii][iv], which highlights the pressing need for raising awareness on the topic. Women generally feel more comfortable asking friends or looking up for information on the internet over sensitive topics. What Ask Tanu will provide them is one-on-one engagement online. This type of private service will encourage women to ask questions and get the right answers pertaining to their health conditions from a verified source. This will also prompt them to consult physicians if they have more pressing questions,” said Dr. Nozer Sheriar leading Obstetrician and Gynecologist based in Mumbai. “With almost nine decades of experience, Bayer has been a true pioneer in the field of women's health, and we are constantly seeking new ways to engage and empower women on the diseases impacting them,” said Manoj Saxena, Managing Director Bayer Zydus Pharma & South Asia Head at Bayer.“We recognize the power and reach of digital platforms today. The launch of Bare Your Pain App and Ask Tanu chatbot, will allow us to connect better and raise awareness amongst women across India. Both platforms will give women access to credible and reliable information anytime, anywhere without having to worry about possible stigma to make the right decisions.” The ‘Bare Your Pain’ app and ‘Ask Tanu’ chatbot will be able to provide 24/7 support and monitoring, along with sharing credible information, for women in India. Both tools are available across India in the English language. ]]> <![CDATA[Cipla sets up chemistry research lab at IISER Pune]]> https://biospectrumindia.com/news/95/15676/cipla-sets-up-chemistry-research-lab-at-iiser-pune.html https://biospectrumindia.com/news/95/15676/cipla-sets-up-chemistry-research-lab-at-iiser-pune.html Thu, 30 Jan 2020 07:00:00 +0530 Cipla Foundation, the social responsibility arm of Cipla Ltd, has funded the set-up of a chemistry research laboratory at the Indian Institute of Science Education and Research (IISER) Pune. The lab aims to provide practical training in Chemistry to undergraduates and researchers in the varsity campus along with support to the national outreach programme for school children. The centre and the labs will help strengthen science education in India by engaging with various stakeholders, including students, academicians, scientists, teachers of schools and undergraduate level science and mathematics.  Dr. Y. K. Hamied, Chairman, Cipla; Rumana Hamied, Managing Trustee, Cipla Foundation and Prof. Jayant B Udgaonkar, Director, IISER Pune were present at the campus for the unveiling of the facility along with senior leaders from Cipla and IISER Pune. The expansive 27,000 square feet, ground plus two floor facility has been constructed in an eco-friendly zone in adherence with the green building GRIHA standards. In line with the international standards of chemistry practicals, four state-of-the-art four laboratories have been set up, each appointed with best-in-class equipment including virtual reality functionalities, interactive gadgets, demonstration facilities and more. In addition to academic learning, the facilities will also be utilized for real-life industry driven research projects and contribute to the latest scientific innovation taking place in the country.     Given the absence of adequate infrastructure for chemistry laboratories in surrounding Pune Municipal Corporation schools and other colleges, lesser privileged students and teachers from these institutions will also be granted access to this facility.  At the event, Dr. Y K Hamied said, “India has the potential to be at the frontier of research and innovation, particularly in the areas of chemistry, healthcare and life-sciences. IISER, Pune will certainly contribute to this achievement with the help of of ‘state-of-the-art’ facilities and this means increased responsibility for both the staff and the students to excel” Prof Jayant, Director of IISER Pune shared, “This is the first industry and academic interaction with IISER and Cipla and I am sure that this is just the beginning. This collaboration will be more fruitful in the areas of pharma research in the years to come”. He also mentioned about the expansion of the outreach programme especially in training of secondary school students and most importantly, the teachers.  The outreach programme will help impart pedagogy training to teachers as well as hands on science education to teachers and students from schools, colleges and universities and ignite passion for science. Over 1000 teachers and 5000 students will be reached out to each year. ]]> <![CDATA[Sai Life Sciences starts hiring for R&T Centre]]> https://biospectrumindia.com/news/95/15678/sai-life-sciences-starts-hiring-for-rt-centre.html https://biospectrumindia.com/news/95/15678/sai-life-sciences-starts-hiring-for-rt-centre.html Thu, 30 Jan 2020 00:00:00 +0530 Sai Life Sciences, one of India's fastest growing Contract Development & Manufacturing Organizations (CDMOs), has announced that it has initiated the recruitment of 300+ scientists for its upcoming integrated Research & Technology (R&T) centre in Hyderabad, India. This will result in doubling the full-time equivalents (FTEs) in the areas of discovery chemistry, process chemistry and analytical chemistry. Making the announcement, Krishna Kanumuri, CEO & MD, Sai Life Sciences said, "We are at a very exciting point in our journey and are looking to expand our team of highly-motivated scientists. This will help us better serve our customers by accelerating their projects involving complex chemistry and next-generation technologies." The current expansion is part of Sai Nxt, an organization-wide initiative aimed at transforming the company into a new generation CDMO, with investments of over US$150 million during the period. Scheduled to be functional by May 2020, the upcoming R&T facility in genome valley, Hyderabad, will have 83,000 sq. ft. of lab space and house state-of-the-art research capabilities with advanced technology platforms. The facility adds to the company's growing range of capabilities and facilities across drug discovery, development and manufacturing. Over the past few months, Sai Life Sciences has added 172 KL cGMP API & Intermediate manufacturing capacity, opened a Biology Lab in Cambridge, Massachusetts, USA, and is setting up a Process R&D Lab in Manchester, UK.  The company is looking to on-board top-notch global scientific talent with M.Sc./PhD / Post Doctorates in synthetic organic/analytical chemistry from reputed academic institutions, and experience in global pharma R&D of up to 20 years, for various roles across levels in discovery chemistry, process R&D, analytical R&D as well as in Biology, DMPK, Toxicology among others. The list of open positions are available on the careers page of the website. ]]> <![CDATA[GSK launches Iodex UltraGel]]> https://biospectrumindia.com/news/95/15687/gsk-launches-iodex-ultragel.html https://biospectrumindia.com/news/95/15687/gsk-launches-iodex-ultragel.html Thu, 30 Jan 2020 00:00:00 +0530 GSK has announced the launch of Iodex UltraGel, a new age clinically proven gel-based body pain solution. Backed by science, the new variant penetrates to the root cause of pain, reduces internal swelling and gives 3X effective relief. ^ With this launch, GSK strengthens its presence in the topical pain relief category. While ordinary counter-irritant pain relief creams give burning sensation on the skin, the new Iodex UltraGel with emulgel formulation contains Diclofenac Diethylamine 1.16% w/w, that penetrates deep to the source of pain to give effective relief. The product has modern sensorial like the pleasant smell, non-greasy texture and cooling sensation which makes it a convenient pain relief solution both at home and on the go. The launch strengthens GSK’s pain relief portfolio in India making it one of the formidable players in the non-prescription space. GSK is a global leader in pain management (OTC). Iodex UltraGel was exclusively previewed at the Indian Orthopaedic Association Annual Conference’19  (IOACON), one of the biggest orthopaedic conglomerations in South Asia. As part of the launch, the brand will be reaching out to over 5000 orthopaedics to promote the clinically proven credentials of the new product.  Naveed Ahmed, Area Marketing Director, GSK said, “Brand Iodex has stayed relevant for over a century making it a household name that is trusted by millions. Today’s changing lifestyle has resulted in an increase in pain occurrences, be it back, neck & shoulder or joint pains.  We are addressing the needs of these sets of consumers by launching Iodex UltraGel, a clinically proven formulation that will offer effective pain relief, making it one of the best pain solutions available in the market. We are confident that this launch will further augment consumer trust in the brand and help strengthen our topical pain relief portfolio.” Iodex is one of India's leading topical pain relievers. It was launched 100 years ago and has since become a household brand, selling over 4 million bottles every month. ]]> <![CDATA[Cipla Foundation sets up state-of-the-art chemistry laboratory at IISER Pune]]> https://biospectrumindia.com/news/95/15677/cipla-foundation-sets-up-state-of-the-art-chemistry-laboratory-at-iiser-pune.html https://biospectrumindia.com/news/95/15677/cipla-foundation-sets-up-state-of-the-art-chemistry-laboratory-at-iiser-pune.html Wed, 29 Jan 2020 00:00:00 +0530 In continuance of its efforts to advance quality education andpromote industry-academia collaboration, Cipla Foundation, the social responsibilityarm of Cipla Ltd, has funded the set-up of a world class chemistry research laboratory at the Indian Institute of Science Education and Research (IISER) Pune. The lab aims to provide practical training in Chemistry to undergraduates and researchers in the varsity campus along with support to the national outreach programme for school children. The centre and the labs will help strengthen science education in India by engaging with various stakeholders, including students,academicians, scientists, teachers of schools and undergraduate level science and mathematics. Dr. Y. K. Hamied, Chairman, Cipla, Ms. Rumana Hamied, Managing Trustee, Cipla Foundation and Prof. Jayant B Udgaonkar, Director, IISER Pune were present at the campus for the unveiling of the facility along with senior leaders from Cipla and IISER Pune.  The expansive 27,000 square feet, ground plus two floor facility has been constructed in an eco-friendly zone in adherence with the green building GRIHA standards. In line with the international standards of chemistry practicals, four state-of-the-art four laboratories have been set up, each appointed with best-in-class equipment including virtual reality functionalities, interactive gadgets, demonstration facilities and more. In addition to academic learning, the facilities will also be utilized for real-life industry-driven research projects and contribute to the latest scientific innovation taking place in the country.       Given the absence of adequate infrastructure for chemistry laboratories in surrounding Pune Municipal Corporation schools and other colleges, lesser privileged students and teachers from these institutions will also be granted access to this facility. The outreach programme will help impart pedagogy training to teachers as well as hands on science education to teachers and students from schools, colleges and universities and ignite passion for science. Over 1000 teachers and 5000 students will be reached out to each year.   At the event, Dr. Y K Hamied, Chairman Cipla Ltd. said, “India has the potential to be at the frontier of research and innovation, particularly in the areas of chemistry, healthcare and life-sciences. IISER, Pune will certainly contribute to this achievement with the help of of ‘state-of-the-art’ facilities and this means increased responsibility for both the staff and the students to excel”   Prof Jayant, Director of IISER Pune shared, “This is the first industry and academic interaction with IISER and Cipla and I am sure that this is just the beginning. This collaboration will be more fruitful in the areas of pharma research in the years to come”. He also mentioned about the expansion of the outreach programme especially in training of secondary school students and most importantly, the teachers.   ]]> <![CDATA[Biocon’s API facility gets 5 observations]]> https://biospectrumindia.com/news/95/15649/biocons-api-facility-gets-5-observations.html https://biospectrumindia.com/news/95/15649/biocons-api-facility-gets-5-observations.html Mon, 27 Jan 2020 12:30:00 +0530 Biocon is Asia's premier biopharmaceutical company that is driven by the vision to make a difference to global healthcare through improved access to high quality, life-saving biotherapeutics by making them affordable for patients across the world.  The company has announced that its API manufacturing facility has completed the pre-approval and GMP U.S. FDA inspection. The US drug regulator issued a Form 483 with five observations for the company's API manufacturing facility.  The US Food and Drug Administration (FDA) conducted a pre-approval inspection (PAI) and Good Manufacturing Practice (GMP) inspection of the Active Pharmaceutical Ingredient (API) manufacturing facility of Biocon.  At the conclusion of the inspection of the Bengaluru facility, which took place between 20 and 24 January 2020, the agency issued a Form 483, with five observations. Biocon will respond to the FDA with a corrective and preventive action plan (CAPA) and is confident of addressing these observations expeditiously. The company said it remains committed to global standards of quality and compliance. ]]> <![CDATA[Abbott presents Dydrogesterone's clinical study data]]> https://biospectrumindia.com/news/95/15640/abbott-presents-dydrogesterones-clinical-study-data.html https://biospectrumindia.com/news/95/15640/abbott-presents-dydrogesterones-clinical-study-data.html Mon, 27 Jan 2020 10:30:00 +0530 A quarter of the women who suffer from infertility in the world, i.e., 15-20 million, reside in India. Moreover, there seems to be a higher prevalence of miscarriage among Indian women, as compared to western data. Scientific solutions such as oral dydrogesterone, which helps improve pregnancy outcomes, are essential. Evidence from over 300 published studies, including the recent LOTUS II study, shows oral dydrogesterone is a potent treatment for many different gynecological disorders, including prevention of miscarriage during the first trimester and for luteal phase support for in-vitro fertilization. Over 60 years, Abbott’s dydrogesterone has had a lasting impact on the lives of millions of women worldwide by helping them with healthy pregnancy outcomes. Commenting on the importance of addressing infertility and pregnancy health in India, Dr. Nandita Palshetkar, President Federation of Obstetric & Gynecological Societies of India (FOGSI), observed, “Though infertility has multiple causes, studies suggest that advancing age of motherhood is one of the key risk factors. Given rapid urbanization and the shift in cultural dynamics, maternal age in India is advancing. Moreover, an increase in the number of miscarriages can lead to an increase in the likelihood of subsequent miscarriages, to 13-17% after the first miscarriage, and 55% after the third miscarriage. This underscores the need for medicines and treatments that ensure healthy pregnancies.” Studies indicate higher prevalence of miscarriage in Indian women with history of miscarriage at 32% , as well as recurrent spontaneous miscarriage at a prevalence as high as 7.5% compared to the global average of 0.8–1.4%. Dr. Ameet Patki, Medical Director, Fertility Associates and the investigator from India for the international LOTUS II study explained, “To have a healthy pregnancy, a woman needs to have sufficient levels of progesterone, which is an important female hormone. A deficiency of progesterone can cause implantation failure and early miscarriages. Dydrogesterone, a progesterone, can increase the chances of a successful pregnancy in women with a history of recurrent abortions. In fact, one study shows that the use of dydrogesterone can reduce theincidence of miscarriage in women by 47%. And the LOTUS I and LOTUS II studies have shown that dydrogesterone can be used effectively and safely for luteal phase support as part of in-vitro fertilization (IVF) treatments. Approximately 40,000 women in India undergoing in vitro fertilization (IVF) treatment each year can benefit from oral dydrogesterone. ” Abbott is the world’s leading manufacturer of dydrogesterone, which has supported over 20 million pregnancies across 100 countries over 60 years. Sieneke Bult-Muntinga, Site Director, Abbott Netherlands commented on the significance of the new indication to support women undergoing IVF treatment, “Both micronized progesterone and dydrogesterone can increase progesterone levels in a woman’s body. Compared to micronized progesterone, dydrogesterone is easily absorbed by the body and is more effective orally. This means dydrogesterone can be effective at a dose that is 10-20 times lower. It is taken orally as a tablet, which is more convenient than a vaginal cream orintramuscular injection. Of course, like any other prescription medicine, it should always be taken as per the advice of one’s doctor.” The repercussions of infertility and pregnancy health go beyond birth outcomes. For many couples, the inability to conceive a child can be devastating. Sieneke Bult-Muntinga said, “Pregnancy is an emotional journey even when everything goes right. Any medicine which can improve the conditions for birth is invaluable. But such medicines need to be of the highest manufacturing quality and need to be accurate in their ingredients. Dydrogesterone with its unique manufacturing process is one of many examples of Abbott's life changing technologies that are helping people live better and healthier lives. And we are proud to aid healthier pregnancies in India by making quality dydrogesteroneavailable in this country.” ]]> <![CDATA[Cadila trains 200 youths through apprenticeship program]]> https://biospectrumindia.com/news/95/15616/cadila-trains-200-youths-through-apprenticeship-program.html https://biospectrumindia.com/news/95/15616/cadila-trains-200-youths-through-apprenticeship-program.html Thu, 23 Jan 2020 10:00:00 +0530 Pharma major Cadila Pharmaceuticals is actively contributing to the central government’s skilling mission through its unique apprenticeship program. With the apprentice program, Cadila Pharma employs almost 200 youths across its plants, thus supporting the central government’s cause of skill development. All the apprentices are enlisted under the National Apprenticeship Promotion Scheme (NAPS). They are also paid the prescribed stipend amount. With an objective of handholding young talent and helping them groom themselves for a better future, Cadila Pharma’s Dholka facility has nearly 100 apprentices in various functions. Similarly, it employs 42 apprentices at its Jammu facility and 52 apprentices at its Ankleshwar facility. Cadila Pharma’s apprentices are deployed across various functions such as production, finance, quality assurance, quality control, supply chain, etc. “The best way to empower today’s youth is to equip them with the right kind of skills and an environment where they can grow. For this reason, we don’t just stop at basic training for the individuals. After completion of the Apprenticeship period, they are converted to Technical Trainees where their training is divided into 2 phases, each phase of 6 months. Many of these apprentices are also absorbed within the company depending on vacancies. We also have an ITI Trainee Engagement Plan where they are engaged for 3 years in the company’s training scheme,” Dr Sunil Singh CHRO, Cadila Pharma said. Cadila Pharma selects candidates with qualifications such as B Pharm, M Pharm, M. Sc, B. Tech, and M.Tech, as well as pass-outs in various trades from Industrial Training Institutes (ITIs), through the apprenticeship portal. The apprenticeship opportunity allows the candidates to refine their skills through on the job training, while also providing a steady stream of skilled workforce to the pharma industry. Cadila Pharma, being an equal opportunity provider, runs multiple focused program to hire and develop young talent in its workforce. With programs like Cadila Young Leadership Program (CYLP), Cadila Sales Excellence Program (CSEP) and Cadila ITI Engagement Program (CIEP), Cadila has made significant strides in creating an ecosystem for young employees to grow. ]]> <![CDATA[Biocon’s Bengaluru unit completes inspection with zero observations]]> https://biospectrumindia.com/news/95/15615/biocons-bengaluru-unit-completes-inspection-with-zero-observations.html https://biospectrumindia.com/news/95/15615/biocons-bengaluru-unit-completes-inspection-with-zero-observations.html Wed, 22 Jan 2020 14:45:00 +0530 Biocon is an innovation-led global biopharmaceuticals company committed to enhance affordable access to complex therapies for chronic conditions like diabetes, cancer and autoimmune. It is a leading global player for high quality biosimilars, APIs including statins, immunosuppressants and specialty molecules. The company has announced that its oral solid dosage manufacturing facility completed pre-approval USFDA inspection with zero observations. The inspection of the Bengaluru facility, which took place between 13 and 17 January 2020, concluded with zero observations and no Form 483 was issued. The company said in statement,"This is to inform you that the U.S. Food and Drug Administration (FDA) conducted a Pre-Approval Inspection (PAI) of the Oral Solid Dosage Manufacturing Facility of Biocon Pharma Ltd, a subsidiary of Biocon Ltd, which was triggered by the submission of an Abbreviated New Drug Application (ANDA).We remain committed to global standards of Quality and Compliance" ]]> <![CDATA[Glenmark sells gynaecology biz for Rs 115 Cr]]> https://biospectrumindia.com/news/95/15611/glenmark-sells-gynaecology-biz-for-rs-115-cr.html https://biospectrumindia.com/news/95/15611/glenmark-sells-gynaecology-biz-for-rs-115-cr.html Wed, 22 Jan 2020 11:00:00 +0530 Mumbai based pharmaceutical company Glenmark Pharmaceuticals has sold its gynaecology business in India and Nepal to private equity firm True North, formerly known as India Value Fund Advisors or IVFA, for Rs 115 crore. The business has been sold to the new entity incorporated by True North called Intergrace. Back in August 2018, Glenmark had  transferred its orthopaedic and pain management business in India and Nepal to True North's new entity Intergrace. ]]> <![CDATA[Johnson & Johnson launches edutainment campaign on TB]]> https://biospectrumindia.com/news/95/15595/johnson-johnson-launches-edutainment-campaign-on-tb.html https://biospectrumindia.com/news/95/15595/johnson-johnson-launches-edutainment-campaign-on-tb.html Tue, 21 Jan 2020 00:00:00 +0530 Johnson & Johnson Services Inc. is proud to announce its collaboration with the internationally acclaimed social change organization the MTV Staying Alive Foundation on a youth-focused 'Edutainment' campaign in India, MTV Nishedh, which aims to raise awareness and reduce stigma around critical health and social issues facing young people. Through an educational grant, Johnson & Johnson is supporting the inclusion of tuberculosis (TB) messaging for the very first time in an MTV Staying Alive campaign, as part of the Company's 10-year initiative to fight TB and in support of the Government of India's goal of ending TB by 2025. One of the seminal components of the MTV Nishedh campaign - a 7-week, 13-part TV drama series, which will air from January 25, 2020, at 8 pm IST on MTV India - was officially announced at an event in Mumbai. Among other storylines, the drama follows the struggles and triumphs of two characters with TB to help inform young people about the signs and symptoms of the disease, encourage those who might be affected to seek care and debunk common myths to help reduce the social stigma often faced by patients.   "It's time to make more people aware of TB, remove the stigma associated with the disease, and help those in need of treatment access the best possible care," said Sarthak Ranade, Managing Director, Janssen India, Johnson & Johnson Private Limited. "At Johnson & Johnson, we have been working closely with the Government of India, NGOs and other local partners to combat TB and DR-TB at all levels by building capacity and expanding access to treatment. Building on this commitment, our Company is incredibly proud to support the MTV Nishedh campaign to empower youth and advocate for a TB-free India." Despite being a preventable and treatable disease, TB kills one person every minute in India, and the vast majority of TB cases are reported among young people in their most productive years. Of the 10 million estimated cases of TB in 2018, only 7 million were diagnosed, meaning there are 3 million 'missing' patients who are not aware that they are infected - approximately 700,000 of which live in India. Further, the emergence of drug-resistant TB (DR-TB) has made addressing the disease even more challenging, and TB is now the leading cause of deaths due to antimicrobial resistance (AMR) globally. Stigma and lack of awareness are often key reasons why those affected are not diagnosed and treated. By engaging young people - which comprise two-thirds of the population in India - MTV Nishedh is setting out to address this. The campaign builds on the success of MTV Staying Alive Foundation's multi-award-winning campaign with proven impact, 'MTV Shuga', which has helped to generate positive behaviour change around HIV and sexual and reproductive health across Africa.  In addition to the TV drama, the J&J-supported campaign also includes a 15-part MTV Nishedh Live radio program, which has been airing on RED FM since October, as well as compelling and informative online content. A peer-to-peer education program, which will also feature TB modules, will be launching soon. "We are thrilled to be working with Johnson & Johnson to include TB in our campaign programming for the first time - particularly in India, a country so hard hit by this devastating disease," said Georgia Arnold, Executive Director of the MTV Staying Alive Foundation and Executive Producer of MTV Nishedh. "We hope that the MTV Nishedh campaign will play a key role in helping to improve diagnosis rates in the country by informing young people about TB, breaking down the stigma around the disease and, ultimately, encouraging youth to treat those impacted by TB with the respect, courtesy and dignity that they deserve." For our part, Johnson & Johnson TB experts provided critical input to the MTV team on the technical aspects of TB disease and enabled TB survivors to inform the campaign to ensure the experiences and emotions faced by patients are realistically portrayed. "Johnson & Johnson is incredibly proud to be working with the MTV Staying Alive Foundation on this important campaign - which we hope will engage more young people in the fight against TB and help bring conversations about this disease out of the shadows," said Cat Oyler, Vice President, Tuberculosis, Global Public Health, Johnson & Johnson. "This collaboration is one of a series of new partnerships that Johnson & Johnson will be undertaking to help reach the 'missing millions' of TB and DR-TB patients in India and around the world, as part of our global 10-year initiative to help create a world without TB." ]]> <![CDATA[Lupin Foundation Wins IDMA Corporate Citizen Award 2019]]> https://biospectrumindia.com/news/95/15597/lupin-foundation-wins-idma-corporate-citizen-award-2019.html https://biospectrumindia.com/news/95/15597/lupin-foundation-wins-idma-corporate-citizen-award-2019.html Tue, 21 Jan 2020 00:00:00 +0530 Pharma major Lupin Limited (Lupin) announced that its corporate social responsibility (CSR) arm, Lupin Foundation, has won the prestigious Indian Drug Manufacturers’ Association (IDMA) Corporate Citizen Award 2019, at the IDMA 58th Annual Day Celebrations held in Mumbai on January 18, 2020. Lupin was conferred this award in the CSR category ‘Initiative towards Agriculture,’ for its beekeeping project that has directly benefitted nearly 4000 families. Lupin is considered a torchbearer in the Bharatpur district of Rajasthan for introducing beekeeping as a means of rural livelihood in the region. While the region is an export hub for honey today, it did not produce any honey prior to 1995. Since its introduction by Lupin, Beekeeping has become a massive programme in the district and provided employment and alternative source of income for farmers. Lupin Foundation’s support extends beyond providing training and microfinance credit to beekeepers. It has helped farmers to establish their network across markets through various state-level and national-level fairs. This enterprising project has provided a livelihood for landless and marginal farmers, and the unemployed rural youth. The honey plant established with the support of the Lupin Foundation is now the number one honey exporter in the country. Commenting on the occasion, Shri Sita Ram Gupta, Executive Director, Lupin Foundation said, “It is an honour to be bestowed with this prestigious award. As a leader in the CSR space, we have always strived to give back to society and make a positive impact. This award recognises the organisation’s commitment to driving progress in society. Such recognitions encourage us to expand our CSR footprint.” For the Beekeeping Project, Lupin Foundation collaborated with the National Mustard Research Center (NMRC) and National Bee Board for knowledge partnership. The Horticulture department of the Rajasthan government as well as the Khadi and Village Industries Commission (KVIC). Going ahead Lupin Foundation plans to extend the beekeeping programme further and enable Rajasthan to produce more than 12 thousand metric tons of honey in the near future. This award recognizes this effort.   ]]> <![CDATA[LifeCell gets accreditation from AATB]]> https://biospectrumindia.com/news/95/15592/lifecell-gets-accreditation-from-aatb.html https://biospectrumindia.com/news/95/15592/lifecell-gets-accreditation-from-aatb.html Mon, 20 Jan 2020 16:20:00 +0530 LifeCell International, India's premier human cells tissues and genetics services provider, has now received accreditation from the American Association of Tissue Banks (AATB) for its birth tissue products. This accreditation positions LifeCell as the first & only company not only in India but also outside the US to receive this accreditation. This accreditation certifies the entire process of consent, birth tissue acquisition, processing, release, storage and distribution. Birth tissue products include the placenta, umbilical cord, and amniotic fluid. Of these the most widely used product is the placental amniotic membrane, which is used as a biological bandage for management of wounds in a variety of specialties such as podiatry, ophthalmology, burns, gynaecology, general and plastic surgery.    This membrane is distributed in a sterile and dehydrated form and used as an intervention when standard wound care has failed. Over 200 growth factors, cytokines and speciality proteins, that are naturally present in the tissue, act as a catalyst for wound closure enabling a quick healing process. A fast and effective wound healing process would substantially decrease medical & hospitalisation costs, treatment period and significantly improve patients' quality of life.   The birth tissue products can be stored at room temperature at hospitals / pharmaceutical outlets without requiring any special storage requirements. Most importantly it can be used on any person without requiring any tissue matching criteria.  With these significant advantages the rising awareness in the recent past has led to a surge in usage of these birth tissue products. The global market for birth tissue derived membrane was valued at USD 2.26 Billion in 2017 with an estimated growth of 12% annually.  LifeCell will soon launch the product in India under the brand "Amchoplast" from it's manufacturing facility in Chennai.  Mr. Mayur Abhaya, Managing Director, LifeCell said, "India is the world's largest birthing country and therefore provides a natural opportunity for India to a leading supplier of these tissues in the world. LifeCell aims to be a global market leader in this category and with this AATB accreditation we would soon set our foot-prints in the global export market to meet the growing demand for birth tissue products."  The American Association of Tissue Banks (AATB) is a professional, non-profit, scientific organization dedicated to improving and saving lives by promoting the safety, quality and availability of donated human tissue. The American Association of Tissue Banks is the premier standard setting body promoting the safety and use of donated human tissue. AATB publishes standards, accredits tissue banks and certifies personnel and is the only national tissue banking organization in the United States. ]]> <![CDATA[Pain for big pharma as US FDA warnings double ]]> https://biospectrumindia.com/reports-white-papers/95/15590/pain-for-big-pharma-as-us-fda-warnings-double-.html https://biospectrumindia.com/reports-white-papers/95/15590/pain-for-big-pharma-as-us-fda-warnings-double-.html Mon, 20 Jan 2020 14:45:00 +0530 Warning letters issued by the US Food and Drug Administration (FDA) to large Indian pharmaceutical firms more than doubled in the first ten months of calendar 2019 compared with 2018. This will impact about 180 abbreviated new drug applications, or 18% of the total pipeline of large drug makers, delaying new product launches, a CRISIL analysis of current regulatory actions, including adverse observations on FDA audit indicates. The US market accounts for more than a third of overall revenue of the big drug makers or Rs 55,000 crore of sales annually. Says Sameer Charania, Director, CRISIL Ratings, “With intensifying regulatory scrutiny, sales growth from the US market will drop to 10-11% during fiscals 2020-22, compared with a growth of 16% in fiscal 2019. Large players are banking heavily on successful launch of complex generic products – these filings have risen to about 25% of the overall new product pipeline from nearly zero three years ago. A substantial delay in resolution of regulatory issues and/or heightened scrutiny could derail the US growth story.” A similar trend was noticed in calendar 2015, when FDA scrutiny of Indian drug makers had intensified largely citing data integrity issues by and large. Consequently, US revenue growth had dropped to 6% in fiscal 2017 as new product launches got delayed amid inherent price erosion. However, the recent FDA observations are relatively less severe and pertain largely to upkeep of facility, cleanliness, and enhanced manufacturing systems. As a result, resolution is expected to be faster. That said, remediation costs to resolve the regulatory observations are likely to increase for big pharma. This is expected to shave off operating profitability by 100-150 basis points over the next two fiscals from the current 19%. Therefore, cost optimisation and rationalisation of research and development expenses will be critical to arrest further decline in operating profitability of these players. Says Tanvi Shah, Associate Director, CRISIL Ratings, “The players are, however, taking steps to contain the impact of regulatory scrutiny and moderate its impact on exports to the US. De-risking strategies such as dual-product filings from different plants and transfer of high-value products to unaffected plants through FDA approvals, which reduce the dependence on a single plant, may help partially contain the impact.” Besides, steady double-digit domestic sales growth, prudent capital expenditure, and strong balance sheets are expected to help the big pharma companies maintain healthy credit metrics. The debt-to-EBITDA ratio is expected to sustain at 1.6-1.7 times over the medium term. ]]> <![CDATA[USFDA approves Strides Loratadine OTC Softgel Capsules]]> https://biospectrumindia.com/news/95/15577/usfda-approves-strides-loratadine-otc-softgel-capsules.html https://biospectrumindia.com/news/95/15577/usfda-approves-strides-loratadine-otc-softgel-capsules.html Fri, 17 Jan 2020 11:15:00 +0530 Strides Pharma Science Limited (Strides) announced that its step‐down wholly owned subsidiary, Strides Pharma Global Pte. Limited, Singapore, has received approval for Loratadine Softgel Capsules, 10 mg (OTC) from the United States Food & Drug Administration (USFDA). The product is a generic version of Claritin® Liqui‐Gels® Capsules, 10 mg, of Bayer HealthCare LLC.   Strides is focusing on building a private label business in the US by leveraging its portfolio of products across soft gels, tablets, capsules and other proprietary formats. Loratadine Softgel Capsules, 10 mg (OTC) is part of Strides niche and small volume product portfolio with limited competition in the US private label market. According to IRi data, the US market for Loratadine Softgel Capsules, 10 mg (OTC) is approximately US$ 50 Mn with only one other generic approval. The product will be manufactured at the company’s Oral dosage facility at Bangalore.      The company has 102 cumulative ANDA filings with USFDA of which 68 ANDAs have been   approved and 34 are pending approval.   ]]> <![CDATA[Metropolis Healthcare to acquire Shraddha Diagnostics]]> https://biospectrumindia.com/news/95/15571/metropolis-healthcare-to-acquire-shraddha-diagnostics.html https://biospectrumindia.com/news/95/15571/metropolis-healthcare-to-acquire-shraddha-diagnostics.html Fri, 17 Jan 2020 00:00:00 +0530 Metropolis Healthcare Ltd, the leading pan-India ‘pathology specialist’, has signed a binding agreement to acquire Ahmedabad based Shraddha Diagnostics Pvt Ltd. With this acquisition, Metropolis has expanded its lab footprint from 17 to 20 in nine cities and towns of Gujarat; Ahmedabad, Surat, Baroda, Mehsana, Rajkot, Navsari, Jamnagar, Bharuch and Gandhidham. Besides, presently, the company has 300 patient service network centres across Gujarat and services over 1500+ clients through its robust B2B network. Ameera Shah, Promoter and Managing Director, Metropolis Healthcare Ltd said, “Gujarat has always been an important market for us. In October 2019, we acquired 4 laboratories in Surat that increased our market share and we are now leaders in the region. With the Ahmedabad acquisition, we are aiming to gain profitable market share by building better leadership, operational capabilities, and expanding our test menu. Our immediate focus would be to fully integrate and modernize these laboratories and in terms of diagnosis,deliver on our promise of integrity, empathy, and accuracy.” Shraddha Diagnostic Pvt Ltd was started by Dr. Hiren Shah and Dr. Dushyant Patel. With these two young and dynamic pathologists joining the Metropolis Family, it is the right launchpad for modern and integrated laboratory services in Ahmedabad. Metropolis has a track record of acquiring and successfully integrating companies by bringing in industry best practices to these acquired businesses including standardized machines and standard operating procedures, in a phased manner, resulting in efficiency and quality enhancement. Metropolis, since 2002 has successfully used its brand strength to established large networks through acquisitions in Chennai, Rajkot, Surat, Bangalore, Pune as well as outside India. ]]> <![CDATA[Wockhardt receives DCGI approval for new drug to tackle AMR]]> https://biospectrumindia.com/news/95/15564/wockhardt-receives-dcgi-approval-for-new-drug-to-tackle-amr.html https://biospectrumindia.com/news/95/15564/wockhardt-receives-dcgi-approval-for-new-drug-to-tackle-amr.html Thu, 16 Jan 2020 13:00:00 +0530 Indian drug regulator, DCGI has approved Wockhardt’s 2 new antibiotics, EMROK (IV) and EMROK O (Oral), for acute bacterial skin and skin structure Infections including diabetic foot infections and concurrent bacteraemia based on the Phase 3 study involving 500 patients in 40 centres across India. The new drug will target superbug like Methicillin resistant Staphylococcus aureus (MRSA), which is a leading cause of rising antimicrobial resistance (AMR). The size of Indian Antibiotic market is approx. 16,000 Crore, growing at 7% and is one of the largest therapeutic segment, with a 12% market share of the Indian Pharmaceutical Market. “By virtue of its broad spectrum activity against widely prevalent pathogens including MRSA, superior safety over the currently available anti-MRSA agents and its unique properties, I believe EMROK/EMROK-O has a strong potential to effectively address the unmet medical need of the clinicians in the country thereby helping to reduce the morbidity and mortality”- said Dr. Habil Khorakiwala, Founder Chairman, Wockhardt Group. Antimicrobial Resistance: A Medical Challenge (38% Resistance in India) AMR is a major public health problem globally. India carries one of the largest burdens of drug‑resistant pathogens worldwide. Infections caused by drug-resistant organisms could lead to increased mortality and prolonged duration of hospitalization, causing a huge financial burden to the affected persons, health-care systems, and hinder the goals of sustainable development. Two million deaths are projected to occur in India due to AMR by the year 2050. World Health Organisation (WHO) in 2017 has listed Methicillin resistant S. aureus (MRSA) as a ‘high’ priority pathogen due to high prevalence of resistance, mortality rate, burden on community and health care settings. In 2018, a national study conducted by the Indian council of Medical research (ICMR) and Anti-microbial resistant surveillance network (AMRSN) group highlighted the high prevalence of 38.6% of MRSA in India4. A recent Indian study reports that 1 in 6 patients infected with multidrug resistant Gram positive infections die in intensive care units.   Limitations of Current Treatments Currently available anti-MRSA agents have multiple side effects such as kidney damage, decrease in platelet cell counts, muscle pain, to name a few; which limits their use for a longer period and compromise the safety of critically ill patients in the ICU. The patient management is further complicated due to increasing resistance to these agents and drying antimicrobial pipeline.   EMROK / EMROK O: The Modern Gram positive Antibiotic against Methicillin Resistant Staphylococcus aureus Infections EMROK and EMROK-O are the first novel chemical entity antibiotics researched and developed in India with various international collaborations across globe. While the non-clinical and Phase 1 studies have been undertaken in U.S. Europe and India, the Phase 2 and Phase 3 clinical studies have been successfully completed in India. More than 50 international publications/posters in top-notch journals/scientific conferences and studies by leading international experts have established that EMROK/EMROK-O represents a truly multi-spectrum MRSA drug with potent bactericidal action against Gram positive, quinolone susceptible Gram negative, anaerobic and atypical bacteria. Clinical and non-clinical studies have established advantageous safety features of EMROK/EMROK-O compared to older MRSA drugs vancomycin, teicoplanin, daptomycin and linezolid which are beset with unfavourable features of nephrotoxicity, bone-marrow toxicity and muscle toxicity therefore cannot be given in patients with impaired kidney/liver function and seriously ill patients requiring for longer duration therapy. After a significant gap of 14 years, a new anti-MRSA agent will be made available by Wockhardt as ‘EMROK’ for the management of resistant superbug. ]]> <![CDATA[Alembic receives USFDA approval for depression drug]]> https://biospectrumindia.com/news/95/15562/alembic-receives-usfda-approval-for-depression-drug.html https://biospectrumindia.com/news/95/15562/alembic-receives-usfda-approval-for-depression-drug.html Thu, 16 Jan 2020 12:00:00 +0530 Alembic Pharmaceuticals Limited (Alembic) has announced that the Company has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Vilazodone Hydrochloride Tablets, 10 mg, 20 mg, and 40 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Viibryd Tablets, 10 mg, 20 mg, and 40 mg, of Allergan Sales, LLC (Allergan). Vilazodone Hydrochloride Tablets are indicated for the treatment of major depressive disorder. Vilazodone Hydrochloride Tablets, 1 O mg, 20 mg, and 40 mg have an estimated market size of US$ 469 million for twelve months ending September 2019 according to IQVIA. Alembic had previously received tentative approval for this ANDA. Alembic was one of the first ANDA applicants to submit a substantially complete ANDA with a paragraph IV certification and hence is eligible for 180 days of shared exclusivity. The launch of this product will be as per settlement agreement with Allergan. Alembic has a cumulative total of 110 ANDA approvals (98 final approvals and 12 tentative approvals) from USFDA. ]]> <![CDATA[Roche Diabetes Care India launches new Accu-Chek Guide]]> https://biospectrumindia.com/news/95/15561/roche-diabetes-care-india-launches-new-accu-chek-guide.html https://biospectrumindia.com/news/95/15561/roche-diabetes-care-india-launches-new-accu-chek-guide.html Thu, 16 Jan 2020 10:00:00 +0530 Roche Diabetes Care (RDC) India has announced the launch of its new Accu-Chek® Guide blood glucose monitoring system, which offers unique features and an innovative design that makes it easy to use. The new Accu-Chek Guide is easy to use with an intuitive user interface and improved testing experience. Accuracy provided by the meter exceeds the ISO 15197:2013/EN ISO 15197:2015 system accuracy criteria for blood glucose monitoring systems.   Easier testing and tighter accuracy Unlike conventional test strip vials, the new Accu-Chek Guide SmartPack test strip vial is spill-resistant. It holds test strips tightly in place while also making it easy to remove just one strip at a time. The test strip quickly wicks just a small drop of blood (0.6 µL) from anywhere on the edge of the wide yellow dosing area, which helps make blood application less of a challenge - especially for those with vision or dexterity issues. The test strip port light and the bright backlit display are particularly helpful for people with poor eyesight or when testing under poor lighting conditions. Once the blood sample has been applied, results are available in less than four seconds. Finally, the strip ejector on the meter enables easy and sanitary removal of the used test strip without having to touch it. The Accu-Chek Guide system delivers an advanced level of accuracy, 10/10, that is even tighter than the current global system accuracy criteria (ISO 15197:2013/EN ISO 15197:2015). Consistently accurate measurements are essential for reliable BG monitoring and deriving the correct therapy decisions.   Connectivity for patient information all in one place The Accu-Chek Guide meter offers Bluetooth low energy connectivity to the mySugr app, providing automatic data logging and secure online data sharing. Results can be transmitted wirelessly from the Accu-Chek Guide meter to the mySugr app on the user’s mobile device, and from there it can be shared with HCPs and caregivers, as needed. The integrated platform provides a clear picture of what’s working for people with diabetes and what’s not. This approach can help turn reliable data into actionable information that can support improved outcomes. “Diabetes management is evolving and has gone beyond just monitoring to include connectivity and communication between people with diabetes and their healthcare professionals to ensure personalised diabetes management. At Roche Diabetes Care India we are prepared to usher in this transformation with cutting edge solutions in the form of integrated personalised diabetes management solutions that connect innovative hardware with digital technology. Successful diabetes management relies on accurate and reliable information. Appropriate use of SMBG (self-monitoring of blood glucose) can enhance diabetes self-management. Non-adherence to routine SMBG remains a common issue in India and world over and people with diabetes report they would test more frequently if the procedure was easier and more discreet. The new Accu-Chek Guide system has been tailored to the specific needs of people with diabetes to make everyday blood glucose monitoring easier, thereby improving adherence.” says Omar Sherief Mohammad, General Manager, Roche Diabetes Care India. ]]> <![CDATA[Sun Pharma enters into partnership with Rockwell Medical]]> https://biospectrumindia.com/news/95/15555/sun-pharma-enters-into-partnership-with-rockwell-medical.html https://biospectrumindia.com/news/95/15555/sun-pharma-enters-into-partnership-with-rockwell-medical.html Wed, 15 Jan 2020 00:00:00 +0530 Sun Pharmaceutical Industries Ltd.and  its subsidiaries and/or associate companies) today announced that one of its wholly-owned subsidiaries has entered into exclusive licensing and supply agreements with Rockwell Medical Inc. (Rockwell), to commercialize Rockwell's Triferic, a proprietary iron replacement and haemoglobin maintenance drug, for treating anaemia in hemodialysis patients in India. Triferic is approved in USA. As per the terms of the agreement, Sun Pharma will be the exclusive development and commercialization partner for Triferic during the term of the agreement, subject to its approval in India. In consideration for the license, Rockwell will be eligible for upfront and milestone payments as well as a royalty on net sales. The financial terms of the agreement are confidential. Kirti Ganorkar, CEO of India business, Sun Pharma, said, “We are excited to build a partnership with Rockwell who has developed an innovative product, Triferic for haemodialysis patients. Triferic is an innovative anaemia therapy for patients who are undergoing haemodialysis and offers a unique treatment option. Triferic will help Sun Pharma expand its portfolio in its core therapy areas.” According to the 2017 Global Burden of Disease Study, chronic kidney disease was the 10th leading cause of mortality in India, having risen from 14th rank in 20071. In India, there are approximately 130,000 patients receiving hemodialysis, and the number is increasing by about 232 per million population ]]> <![CDATA[ AstraZeneca's Lynparza gets FDA priority review for PAOLA-1]]> https://biospectrumindia.com/news/95/15548/-astrazenecas-lynparza-gets-fda-priority-review-for-paola-1.html https://biospectrumindia.com/news/95/15548/-astrazenecas-lynparza-gets-fda-priority-review-for-paola-1.html Tue, 14 Jan 2020 14:45:00 +0530 AstraZeneca and MSD Inc. have announced that a supplemental New Drug Application for Lynparza (olaparib) in combination with bevacizumab has been accepted and granted Priority Review in the US for the maintenance treatment of patients with advanced ovarian cancer who are in complete or partial response to 1st-line platinum-based chemotherapy with bevacizumab. A Prescription Drug User Fee Act (PDUFA) date is set for the second quarter of 2020. The Priority Review by the US Food and Drug Administration (FDA) was based on results from the pivotal Phase III PAOLA-1 trial. The trial compared Lynparza when added to standard-of-care (SoC) bevacizumab vs. bevacizumab alone in patients with advanced ovarian cancer in the 1st-line maintenance setting, regardless of their biomarker status or outcome from previous surgery. The investigator-assessed results showed Lynparza added to bevacizumab reduced the risk of disease progression or death by 41% based on a hazard ratio of 0.59 (p<0.0001) and improved progression-free survival (PFS) to a median of 22.1 months vs. 16.6 months for patients treated with bevacizumab alone. At two years after trial initiation, 46% of patients treated with Lynparza added to bevacizumab showed no disease progression vs. 28% of patients treated with bevacizumab alone. The safety and tolerability profiles of Lynparza and bevacizumab were consistent with previous trials for each medicine and showed no detriment to quality of life. Lynparza is the only PARP inhibitor with two positive randomised Phase III trials in the 1st-line maintenance setting for advanced ovarian cancer. It is the only PARP inhibitor approved in the US as a 1st-line maintenance treatment for patients with BRCA-mutated advanced ovarian cancer, based on the SOLO-1 trial. If approved, this would be the fourth indication for ovarian cancer patients in the US for Lynparza. ]]> <![CDATA[P&G Health partners with PHFI for digital project at Goa ]]> https://biospectrumindia.com/news/95/15537/pg-health-partners-with-phfi-for-digital-project-at-goa-.html https://biospectrumindia.com/news/95/15537/pg-health-partners-with-phfi-for-digital-project-at-goa-.html Mon, 13 Jan 2020 16:50:00 +0530 Procter & Gamble Health Limited has announced its partnership with the Public Health Foundation of India (PHFI) to implement a digital health project in the state of Goa under its corporate social responsibility (CSR) program ‘SEHAT’. Speaking about the program, Milind Thatte - Managing Director, Procter & Gamble Health Limited stated, “The uniqueness of this project is the coming together of diverse partners who are pooling in their resources and expertise to make a sustainable difference to public health in the state. Funded by P&G Health, the project will be implemented by PHFI in partnership with the Directorate of Health Services Goa and Department of Women & Child Development Goa and comprises the deployment of PHFI’s ‘Swasthya Sahayak’ digital device at 30 ‘Health and Wellness Centers’ to improve delivery of reproductive and maternal health services.” The project was launched at an event at Goa by Minister Smriti Irani (Union Minister of Women and Child Development, and Textiles), Minister Dr. Pramod Sawant (Chief Minister of Goa), Minister Vishwajit P Rane (Minister of State for Health, Women and Child Development, Skill Development, Industries, Trade and Commerce & Law and Judiciary), Dr. K Srinath Reddy (President- Public Health Foundation of India) and Milind Thatte (Managing Director – Procter & Gamble Health Limited). Speaking at the launch event, Vishwajit P Rane stated, “We are very excited to be working with P&G Health and PHFI to deploy this innovative program at ‘Health & Wellness Centres’ across Goa. Using the portable ‘Swasthya Sahayak’ device, frontline health workers and anganwadi workers will be able to digitize health information of families, conduct diagnostic tests for early detection of deficiencies, identify high-risk pregnancy cases for timely referrals, and help promote healthy lifestyles that benefit both mother and child. Our teams at the Directorate of Health Services, and Department of Women & Child Development will be working together to extend all required support to PHFI to ensure effective project execution and impact.” Procter & Gamble Health Limited (PGHL) aims to channel its CSR efforts towards building a Healthier India through its umbrella program ‘SEHAT’. Projects under SEHAT include, but are not limited to Preventive Health, Community Health and Public Health interventions; Health Awareness, screening and education; Financial Support for Healthcare needs of marginalized & underprivileged communities; Capability-Building of Healthcare Professionals, Healthcare Infrastructure and Healthcare Assistance as part of disaster relief and support.   ]]> <![CDATA[Lupin’s Ankleshwar facility wins par excellence award at 33rd NCQC]]> https://biospectrumindia.com/news/95/15534/lupins-ankleshwar-facility-wins-par-excellence-award-at-33rd-ncqc.html https://biospectrumindia.com/news/95/15534/lupins-ankleshwar-facility-wins-par-excellence-award-at-33rd-ncqc.html Mon, 13 Jan 2020 12:40:00 +0530 Pharma major Lupin Limited (Lupin) won the Par Excellence Award at the 33rd National Convention on Quality Concept (NCQC), organised by the Quality Circle Forum of India (QCFI).  The event was held  at IIT BHU — Varanasi from November 26 -30, 2019. Lupin’s nomination summarised its transformation project to improve the yield and quality of Cefadroxil products.  Speaking on the occasion, Rajendra B Chunodkar, President — Manufacturing Operations, Lupin said, “As a leading pharmaceutical company, we have persistently focused our efforts toward enabling manufacturing excellence at all our sites. This award endorses our approach and felicitates our efforts toward quality and continuous improvement.” Twice in short succession, Lupin’s Ankleshwar facility received recognition for its “Cefadroxil Yield and Quality Improvement " project.  In the previous  instance, the facility won the gold award by the American Society for Quality at the Annual Conference on Quality Management in Ahmedabad. ]]> <![CDATA[FDA approves Merck’s keytruda for Invasive bladder cancer treatment]]> https://biospectrumindia.com/news/95/15513/fda-approves-mercks-keytruda-for-invasive-bladder-cancer-treatment.html https://biospectrumindia.com/news/95/15513/fda-approves-mercks-keytruda-for-invasive-bladder-cancer-treatment.html Thu, 09 Jan 2020 13:10:00 +0530 Merck, known as MSD outside the United States and Canada, has announced that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA, Merck’s anti-PD-1 therapy, as monotherapy for the treatment of patients with Bacillus Calmette-Guerin (BCG)-unresponsive, high-risk, non-muscle invasive bladder cancer (NMIBC) with carcinoma in situ (CIS) with or without papillary tumors who are ineligible for or have elected not to undergo cystectomy. “Today’s approval of KEYTRUDA reinforces our company’s commitment to expanding existing treatment options for certain patients with high-risk, non-muscle invasive bladder cancer,” said Dr. Scot Ebbinghaus, vice president, clinical research, Merck Research Laboratories. “As the first anti-PD-1 therapy approved in this setting, KEYTRUDA will be a new clinical option for a patient population that previously had limited FDA-approved therapies available.” “High-risk, non-muscle invasive bladder cancer is a serious disease, characterized by frequent recurrences and progression,” said Arjun V. Balar, M.D., associate professor of Medicine and director of Genitourinary Medical Oncology at NYU Langone Health’s Perlmutter Cancer Center. “Historically, patients with high-risk, non-muscle invasive bladder cancer with CIS whose cancer is unresponsive to BCG treatment had limited non-surgical treatment options. As a physician who specializes in the management of bladder cancer, it is encouraging to now have a new treatment option for these patients.” ]]> <![CDATA[Serum Institute, Aragen Bio announce vaccine development collaboration]]> https://biospectrumindia.com/news/95/15509/serum-institute-aragen-bio-announce-vaccine-development-collaboration.html https://biospectrumindia.com/news/95/15509/serum-institute-aragen-bio-announce-vaccine-development-collaboration.html Thu, 09 Jan 2020 10:00:00 +0530 Aragen Bioscience, Inc., a subsidiary of GVK BIO and one of the leading preclinical ORCs specializing in the development of monoclonal antibodies and other products based on large molecules , and Serum Institute of India Pvt. Ltd. (SIIPL), the world's largest vaccine manufacturer, are pleased to announce their collaboration on the development of multiple stable cell lines to support Serum's HIV program.  This partnership between Serum and Aragen brings together two organizations committed to "Accelerating R&D in the life sciences", with the objective of developing affordable monoclonal antibodies that improve the quality of life for human beings. Aragen will leverage its expertise in the RapTr ™ platform , which uses proprietary vectors and CHO DG44 host cells to develop cell lines. Combined with the analytical platform, Aragen is preparing to supply Serum with high extraction cell lines allowing Serum to rapidly advance its program towards manufacturing. With a proven experience of more than 50 years in the development of affordable drugs, Serum will focus its efforts on the transformation of these innovative molecules into vaccines or decisive treatments that treat and prevent diseases around the world. "We are delighted to partner with the world leader in vaccines," said Manni Kantipudi, President of Aragen and President and CEO of GVK BIO . “The Aragen team is renowned worldwide for its ability to clone and express complex proteins. Through this collaboration with Serum, we hope to use this expertise to develop and deliver affordable organic products. " “SIIPL is very happy to collaborate with Aragen. SIIPL is already collaborating with IAVI and Scripps Research to discover innovative monoclonal antibodies against HIV. Thanks to our manufacturing capabilities and this collaboration to develop stable cell lines with Aragen, SIIPL will be able to provide cost-effective monoclonal antibodies against HIV for developing and developed countries, "said Mr. Adar Poonawalla, CEO of SIIPL . ]]> <![CDATA[IIL unveils eco-friendly pack for anti-rabies vaccine]]> https://biospectrumindia.com/news/95/15505/iil-unveils-eco-friendly-pack-for-anti-rabies-vaccine.html https://biospectrumindia.com/news/95/15505/iil-unveils-eco-friendly-pack-for-anti-rabies-vaccine.html Wed, 08 Jan 2020 20:00:00 +0530 As a socially committed organization Human Biologicals Institute, a division of Indian Immunologicals Limited (IIL) - a leading vaccines company, has announced that it has taken a significant step towards reducing the plastic burden on the environment by launching an eco-friendly pack for its highly successful Anti Rabies Vaccine – Abhayrab. The vaccine has saved millions of lives from the fatal Rabies disease since its launch two decades ago.  As per a study conducted by ASSOCHAM, India is likely to generate about 775.5 tonnes of medical waste per day by 2022 at a compounded annual growth rate (CAGR) of about 7 percent. The new packaging of Abhayrab is manufactured using only paper-based materials which helps in reducing the carbon footprint as well. The organization supplies millions of Abhayrab dosages every year through governmental organizations, medical practitioners and in retail markets. Speaking on the occasion Dr. K. Anand Kumar, Managing Director, IIL said, “As a responsible organization, we make conscious efforts to contribute to the society, including the important one to reduce the plastic burden on the environment. The introduction of an eco-friendly pack of Abhayrab will help reducing more than 160 tons of plastic used each year. The smaller eco-friendly packing will also require less storage and transportation space, thus reducing energy consumption.” The Human Biologicals Institute has always believed that awareness plays a major role in rabies prevention. To combat the issue, a digital campaign ‘Fearless against Rabies’ has been developed to create awareness among the public and medical practitioners. This campaign was launched at an experts’ conclave at Hyderabad in the presence of key opinion leaders in rabies management from across the country. ]]> <![CDATA[AstraZeneca’s heart failure drug Farxiga gets FDA priority review ]]> https://biospectrumindia.com/news/95/15487/astrazenecas-heart-failure-drug-farxiga-gets-fda-priority-review-.html https://biospectrumindia.com/news/95/15487/astrazenecas-heart-failure-drug-farxiga-gets-fda-priority-review-.html Tue, 07 Jan 2020 13:05:00 +0530 AstraZeneca has announced the US Food and Drug Administration (FDA) has accepted a supplemental New Drug Application (sNDA) and granted Priority Review for Farxiga (dapagliflozin) to reduce the risk of cardiovascular (CV) death or the worsening of heart failure (HF) in adults with heart failure with reduced ejection fraction (HFrEF) with and without type-2 diabetes (T2D). Farxiga is a first-in-class, oral once-daily selective inhibitor of human sodium-glucose co-transporter 2 (SGLT2). The Prescription Drug User Fee Act date, the FDA action date for this supplemental application, is scheduled for the second quarter of 2020. The sNDA was based on results from the landmark Phase III DAPA-HF trial published in September 2019 in The New England Journal of Medicine, which showed Farxiga on top of standard of care reduced the incidence of the composite outcome of CV death or the worsening of HF versus placebo. Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, said: “Farxiga is well established in the treatment of type-2 diabetes and this Priority Review shows its potential to also impact millions of patients with heart failure. If approved, Farxiga will be the first and only medicine of its kind indicated to treat patients with heart failure.” In September 2019, the FDA granted Fast Track designation for the development of Farxiga in HF. In August 2019, the FDA also granted Fast Track designation for the development of Farxiga to delay the progression of renal failure and prevent CV and renal death in patients with chronic kidney disease, with and without T2D. Farxiga is indicated as a monotherapy and as part of combination therapies to improve glycaemic control in adults with T2D. In October 2019, the FDA also approved Farxiga to reduce the risk of hospitalisation for heart failure in patients with T2D and established cardiovascular disease or multiple CV risk factors. ]]> <![CDATA[Glenmark receives ANDA approval for Deferasirox Tablets ]]> https://biospectrumindia.com/news/95/15485/glenmark-receives-anda-approval-for-deferasirox-tablets-.html https://biospectrumindia.com/news/95/15485/glenmark-receives-anda-approval-for-deferasirox-tablets-.html Tue, 07 Jan 2020 11:45:00 +0530 Glenmark Pharmaceuticals has been granted final approval by the United States Food & Drug Administration (U.S. FDA) for Deferasirox Tablets for Oral  Suspension,  125  mg,  250  mg  and  500  mg,  the  generic  version  of  Exjade® Tablets  for  Oral Suspension, 125 mg, 250 mg and 500 mg, of Novartis Pharmaceuticals Corporation.   According to IQVIATM sales data for the 12‐month period ending November 2019, the Exjade® Tablets  for Oral  Suspension,  125 mg,  250 mg  and  500 mg market2 achieved annual  sales  of approximately $106.4 million. Glenmark’s  current  portfolio  consists  of  165  products  authorized  for  distribution  in  the  U.S.  marketplace and 43 ANDA’s pending approval with the U.S. FDA. ]]> <![CDATA[Polyganics achieves CE mark certification for LIQOSEAL]]> https://biospectrumindia.com/news/95/15490/polyganics-achieves-ce-mark-certification-for-liqoseal.html https://biospectrumindia.com/news/95/15490/polyganics-achieves-ce-mark-certification-for-liqoseal.html Tue, 07 Jan 2020 00:30:00 +0530 Polyganics, a medical technology company developing, manufacturing and commercializing bioresorbable medical devices, has announced that it has obtained CE marking for LIQOSEAL®, its easy-to-use and innovative dural sealant patch, and will launch the device in Europe with immediate effect. Approval of the CE mark is based on outstanding data from polyganics encase I clinical trials, evaluating the safety and performance of LIQOSEAL® in reducing cerebrospinal fluid (CSF) leakage after elective cranial surgery. 3-month follow-up results showed the absence of CSF leakage, as confirmed by MRI, no clinically significant swelling, and no device-related adverse events following surgery. Initially, Polyganics will commercialize LIQOSEAL® in selected European countries with renowned distribution partners which have extensive experience in neurosurgical products. During 2020, the Company will then grow its network with the addition of multiple distributors throughout Europe. Polyganics is also preparing to launch LIQOSEAL® in selected non-European countries. In addition, arrangements are well underway for the start of ENCASE II, a randomized controlled trial, which will enable the Company to submit the patch for pre-market approval to the US Food and Drug Administration. Rudy Mareel, CEO of Polyganics, commented: “CSF leakage remains a devastating complication of neurosurgical procedures and represents a significant patient burden with a high associated cost. The CE approval of this product is testament to the strength and quality of the clinical data from ENCASE I, showing that LIQOSEAL® establishes effective and enduring watertight dural closure. This is a key milestone in our journey to deliver our dural sealant patch to surgeons and patients in Europe and ultimately worldwide.” ]]> <![CDATA[Bausch + Lomb introduces MEDIVISION contact lenses]]> https://biospectrumindia.com/news/95/15478/bausch-lomb-introduces-medivision-contact-lenses.html https://biospectrumindia.com/news/95/15478/bausch-lomb-introduces-medivision-contact-lenses.html Mon, 06 Jan 2020 16:05:00 +0530 Bausch + Lomb, the global leader in contact lenses and lens care solutions recently announced the launch of MEDIVISION contact lenses – the first and only contact lens brand that is available exclusive through Hospitals and Ophthalmologists. With MEDIVISION, Bausch + Lomb, a brand renowned world over for their history and quality, aims to provide a viable and effective option that can be the first step in the refractive journey of young patients before they are ready for refractive surgery. MEDIVISION is primarily aimed at people who for various reasons either don’t want or qualify for a LASIK surgery. For such people, MEDIVISION would offer natural vision and comfort. These monthly disposable contact lenses have been priced at Rs 1499. Speaking about the launch Mr. Sanjay Bhutani, Managing Director, Bausch + Lomb India said, “Bausch + Lomb has always been at the forefront of bringing quality solutions to our consumers. With MEDIVISION we are aiming to bridge a gap faced by our consumers in their refractive journey, by providing them the experience of natural, uninhibited vision from the early stages of vision correction needs. We believe in helping our consumers to See Better Live Better and seeing the world naturally is a big part of that experience. With MEDIVISION, we are bringing the experience of natural vision to all patients.” With the launch of MEDIVISION, Bausch + Lomb has also introduced an exclusive education programme- MediQuest, for the hospitals and optometrists. The objective of this programme is to equip Eye Care Professionals to provide optimal level of care and advice related to Contact Lenses. Bausch + Lomb would be collaborating with leading eye-care hospitals across the country to make MEDIVISION available for patients. Leading Ophthalmologists across these hospitals have expressed their faith in the product and would be recommending it to their patients.   ]]> <![CDATA[Lupin’s Ankleshwar Facility wins award from American Society for Quality ]]> https://biospectrumindia.com/news/95/15463/lupins-ankleshwar-facility-wins-award-from-american-society-for-quality-.html https://biospectrumindia.com/news/95/15463/lupins-ankleshwar-facility-wins-award-from-american-society-for-quality-.html Fri, 03 Jan 2020 11:20:00 +0530 Lupin has won the gold award at the 9th Annual Conference on Quality Management, organised by the American Society for Quality (ASQ) at Ahmedabad on 22 November, 2019. The nomination case study submitted for this award summarised the transformation project to improve the yield and quality of Lupin’s Cefadroxil products. Speaking on the occasion, Rajendra B Chunodkar, President — Manufacturing Operations, Lupin Ltd. said, “It is a moment of pride. This is the fourth consecutive year that Lupin’s Ankleshwar facility has won the Gold Award from the American Society for Quality. As a leading pharmaceutical company, we have constantly focused our efforts towards enabling manufacturing excellence at all our manufacturing sites. This award highlights and validates our approach toward quality and continuous improvement.” While, this year Lupin’s nomination highlighted the key outcomes of its “Cefadroxil Yield and Quality Improvement” project, in the past three years, Lupin won the award for projects that focused on Ethambutol Yield Improvement (2018), 7AE Yield Improvement (2017) and 7ACCA Yield Improvement (2016). ]]> <![CDATA[Lupin's Ankleshwar Facility wins recognition]]> https://biospectrumindia.com/news/95/15462/lupins-ankleshwar-facility-wins-recognition.html https://biospectrumindia.com/news/95/15462/lupins-ankleshwar-facility-wins-recognition.html Fri, 03 Jan 2020 10:35:00 +0530 Pharma major Lupin Limited (Lupin) won the gold award at the 9th Annual Conference on Quality Management, organised by the American Society for Quality (ASQ) at Ahmedabad on 22 November, 2019. The nomination case study submitted for this award summarised the transformation project to improve the yield and quality of Lupin’s Cefadroxil products. Speaking on the occasion, Rajendra B Chunodkar, President — Manufacturing Operations, Lupin Ltd. said, “It is a moment of pride. This is the fourth consecutive year that Lupin’s Ankleshwar facility has won the Gold Award from the American Society for Quality. As a leading pharmaceutical company, we have constantly focused our efforts towards enabling manufacturing excellence at all our manufacturing sites. This award highlights and validates our approach toward quality and continuous improvement.” While, this year Lupin’s nomination highlighted the key outcomes of its “Cefadroxil Yield and Quality Improvement” project, in the past three years, Lupin won the award for projects that focused on Ethambutol Yield Improvement (2018), 7AE Yield Improvement (2017) and 7ACCA Yield Improvement (2016). ]]> <![CDATA[Indoco Remedies receives FDA nod for gout medication]]> https://biospectrumindia.com/news/95/15452/indoco-remedies-receives-fda-nod-for-gout-medication.html https://biospectrumindia.com/news/95/15452/indoco-remedies-receives-fda-nod-for-gout-medication.html Thu, 02 Jan 2020 06:05:00 +0530 Indoco Remedies Ltd., headquartered in Mumbai, is a fully integrated, research-oriented pharma Company with presence in 55 countries. The company has received final approval of its ANDA for Febuxostat Tablets 40 mg and 80 mg, which is therapeutically equivalent to the Reference Listed Drug (RLD), viz., Uloric Tablets 40 mg and 80 mg of Takeda Pharmaceuticals U.S.A., Inc. The market size of Febuxostat Tablets in USA is over USD 500 million. Febuxostat is used for the treatment of gout caused by excessive levels of uric acid in the blood (Hyperuricemia). Febuxostat prevents the production of uric acid by blocking the activity of the enzyme (xanthine oxidase) that converts purines to uric acid. Uric acid forms crystals in joints and tissues, causing inflammation and pain. Hyperuricemia can cause kidney disease and kidney stones as well. Commenting on this achievement Ms. Aditi Kare Panandikar, Managing Director - Indoco Remedies Ltd. said, “Receipt of ANDA approval for Febuxostat Tablets for the US market is very encouraging and has added another feather to Indoco’s cap." ]]> <![CDATA[GSK completes divestment of rabies and tick-borne encephalitis vaccines to Bavarian Nordic]]> https://biospectrumindia.com/news/95/15455/gsk-completes-divestment-of-rabies-and-tick-borne-encephalitis-vaccines-to-bavarian-nordic.html https://biospectrumindia.com/news/95/15455/gsk-completes-divestment-of-rabies-and-tick-borne-encephalitis-vaccines-to-bavarian-nordic.html Wed, 01 Jan 2020 17:55:00 +0530 GlaxoSmithKline has announced the completion of the divestment of travel vaccines Rabipur (tradename Rabavert in the US) for the prevention of rabies, and Encepur for the prevention of tick-borne encephalitis, to Bavarian Nordic. Consistent with the terms of the agreement first announced on October 21st 2019, GSK has received an upfront payment of EUR308 million (£263m), and in due course will receive further milestone payments for a total consideration of up to EUR955 million. The decision to divest these brands supports GSK’s strategic intent to increase focus and reinvest in growth assets, innovation and a simplified supply chain in its vaccines business. Rabipur is a well-established life-saving vaccine (rabies virus causes acute invariable fatal disease) with 30 years of market experience supported by extensive clinical and safety evidence and WHO pre-qualification. It is indicated both in persons bitten by suspect animals (PEP) and non-immune subjects at risk of rabies (PrEP). Encepur is indicated for active immunization of high-risk populations against tick-borne encephalitis (TBE). It has unique dosing flexibility supported by proven efficacy and long-term persistence data.   ]]> <![CDATA[Novadoz /MSN Labs get FDA approval of generic Febuxostat tablets]]> https://biospectrumindia.com/news/95/15450/novadoz-msn-labs-get-fda-approval-of-generic-febuxostat-tablets.html https://biospectrumindia.com/news/95/15450/novadoz-msn-labs-get-fda-approval-of-generic-febuxostat-tablets.html Wed, 01 Jan 2020 14:15:00 +0530 Novadoz Pharmaceuticals, the U.S based sales & marketing affiliate for MSN Labs, based in Hyderabad India, has received FDA approval for their generic version of Febuxostat 40mg and 80mg tablets.  The product is AB rated to the brand Uloric©, marketed by Takeda Pharmaceuticals America, Inc.  The company has commenced shipping of the product that is available in bottles of 30 tablets. Febuxostat brand and generic sales are trending over $430MIL over the previous 12 months according to recent published sales data. Febuxostat is a xanthine oxidase inhibitor indicated for the chronic management of hyperuricemia (elevated levels of uric acid) in adult patients with gout who have a poor response to a maximally titrated dose of Allopurinol, patients intolerant to Allopurinol, and for treatment where Allopurinol is not advisable. Seshu Akula, Novadoz President North America Generics, states, "FDA approval of Febuxostat is the 12th product introduction for the Novadoz label in the first 20 months of our U.S commercialization.  Novadoz and the MSN organizations are committed to being part of DAY 1 and DAY 181 product launches, providing high value to our customers, and to the pharmacies and companies in their supply chain. Our vertical integration through MSN, the #1 API supplier in the world, continues to define our success now and in the future.  We expect continued success in 2020 with multiple product approvals, including several in the specialty oncology space." Tom DeStefano, Novadoz Vice President Sales & Marketing quotes, "2019 had many successes in our first full year of operation.  We have gratitude for the customers that placed confidence in our ability to supply high volume, and specialty products.  Our successful supply chain management ensures customers on-time order fulfillment.  The FDA approval of Febuxostat furthers our emergence as a future leader in the generic pharma industry."   MSN Labs is engaged in the development and manufacturing of API (active pharmaceutical ingredients), KSMs (key starting materials), and product intermediates.  MSN is the global leader in this category. Additionally, the company also manufactures oral solids, liquids, and specialty injectable products in sixty-five markets throughout the world, doing business in the U.S as Novadoz Pharmaceuticals. ]]> <![CDATA[Medkart gives out expansion plans for next three years]]> https://biospectrumindia.com/news/95/15441/medkart-gives-out-expansion-plans-for-next-three-years.html https://biospectrumindia.com/news/95/15441/medkart-gives-out-expansion-plans-for-next-three-years.html Tue, 31 Dec 2019 06:05:00 +0530 Ahmedabad based Medkart Pharmacy has aggressive expansion plans to strengthen the footprints across the Gujarat and nearby states. Aiming to benefit more and more people financially by providing them genuine, affordable and branded generic drugs, Medkart is eying to open 250+ stores in the next three years. Speaking on the company's plans, Parasharan Chari, Founder, and Director, Medkart Pharmacy Pvt. Ltd. said "Opening more stores are part of the company's strategy to increase company's retail sales through direct interaction with customers. The company aims to cover 60% of population of Gujarat by opening stores in all the towns, irrespective of company own or franchise formats. About 90 percent of our sales come from chronic segment therapies like diabetes and cardiac problems. The company currently makes around Rs 20 crores turnover a year and with this expansion plan, we are expecting a turnover of Rs. 300 crores by the year 2023.” Ankur Agarwal, Founder, and Director of the company said "Gujarat's generic drug market is around Rs. 300 crores and will reach Rs. 800 crore in the next three years. As the state has no. of pharmaceutical companies and contract manufacturers for drugs, it enjoys around 30% share in overall exports of generic drugs from India. As the awareness for generic drugs is rising, the adoption of generic medicines will increase multiple folds and that will become the new norm. We expect the government to implement the prescription guidelines set by them so that consumers can be benefited." Headquartered in Ahmedabad, Medkart has total 31 pharmacy stores across the state out of which 19 are company-owned stores and rest are with the franchise models. Apart from Gujarat, the company also has a presence in Rajasthan and Maharastra. Started in September 2014 by young entrepreneurs, Medkart Pharmacy has the largest range of 1500+ molecules in generic drugs, more than any generic medical store across Gujarat. More than 1500 doctors buy their own medicines from Medkart. Till date, Medkart Pharmacy has saved around Rs. 80 crores for over two lakh patients by providing affordable generic drugs. For every Rs. 10 spent on Medkart, Rs. 25 is saved by the customer. Medical Council of India (MCI) had issued a circular five-years ago directing doctors to prescribe generic medicines. However, the same has not been followed and the ground reality is that doctors continue to prescribe expensive branded drugs.   ]]> <![CDATA[Dr Reddy's launches generic hypotensive injection in US]]> https://biospectrumindia.com/news/95/15443/dr-reddys-launches-generic-hypotensive-injection-in-us.html https://biospectrumindia.com/news/95/15443/dr-reddys-launches-generic-hypotensive-injection-in-us.html Tue, 31 Dec 2019 06:00:00 +0530 Dr. Reddy’s Laboratories Ltd. has announced the launch of Sodium Nitroprusside Injection, 50 mg/2 mL (25 mg/mL) Single-dose Vial, the therapeutic generic equivalent of Nitropress® (sodium nitroprusside) Injection, 50 mg/2mL vial, approved by the U.S. Food and Drug Administration (USFDA).    According to IQVIA Health, The Nitropress® brand and generics had U.S. sales of approximately $8 million MAT for the most recent twelve months ending in October 2019 .  Dr. Reddy’s Sodium Nitroprusside Injection is available in single-dose 50 mg/2 mL (25 mg/mL) vials.  Nitropress® is a trademark of Hospira, Inc. Sodium Nitroprusside is indicated for the immediate reduction of blood pressure of adult and pediatric patients in hypertensive crises. ]]> <![CDATA[Suraksha Naturals launches Antioxidant in Easy to Use Spray]]> https://biospectrumindia.com/news/95/15427/suraksha-naturals-launches-antioxidant-in-easy-to-use-spray.html https://biospectrumindia.com/news/95/15427/suraksha-naturals-launches-antioxidant-in-easy-to-use-spray.html Fri, 27 Dec 2019 09:50:00 +0530 Indian brand Suraksha Naturals is known in their home market, and across the globe for their superior quality health and wellness products that combine the proven history of Ayurvedic Medicine with the innovation of modern science. Most famously, Suraksha's Keto-Veyda product line caters to customers who are looking for natural, holistic supplements and shakes that work in conjunction with a keto diet. One such product attracting the attention of health-conscious consumers, as well as anti-aging scientists is Suraksha's Glutathione Spray. Glutathione (GSH) is a powerful, naturally occurring antioxidant comprised of amino acids that can help fight cell damage. Though the human body produces GSH on its own, internal production seems to slow with age, leaving cells more susceptible to damage, and become harder to repair. The three vital amino acids that form into glutathione are cysteine, glutamate, and glycine. While taking supplemental forms of each of these amino acids separately can be beneficial, the effect is not the same as taking fully ready to absorb GSH dose.  Suraksha's sprayable GSH is designed to be easily and immediately absorbed by the body since supplement sprays do not require digestion to extract the vitamin component. Supplement sprays are also highly effective for people who have a difficult time swallowing vitamins, which can include adults with swallowing disorders, as well as people undergoing certain types of cancer treatment. Glutathione is often used by cancer patients because of its ability to combat free radicals, the molecules that cause damage to the body's cell structures. In addition to protecting healthy cells from future damage, GSH can begin the process of repairing cells damaged by age or illness, as it acts as a detoxifying agent in the body. Other common uses for glutathione include natural prevention of ailments like glaucoma, liver disease, and heart disease, and it is also used side by side with conventional medicine in the treatment of immune disorders like Chronic Fatigue, Hepatitis, and HIV. Though GSH is naturally produced in the human body, when supply levels begin to drop off, supplemental sources can be found in nature - from plant sources to fungi, animal sources, and even certain types of bacteria. Suraksha Natural's Glutathione is an appealing and accessible alternative to swallowing dozens of pills or tablets, which often deliver a less pure form of this essential antioxidant. Suraksha Naturals is set to debut its revolutionary health and wellness product to American buyers in 2019. In addition to its GSH spray, the company will introduce its full line of natural, holistic supplements sprays, as well as a variety of other products that will be available for purchase for the first time. ]]> <![CDATA[Nectar Biopharma rolls out generic diabetes drug]]> https://biospectrumindia.com/news/95/15418/nectar-biopharma-rolls-out-generic-diabetes-drug.html https://biospectrumindia.com/news/95/15418/nectar-biopharma-rolls-out-generic-diabetes-drug.html Thu, 26 Dec 2019 09:05:00 +0530 In what comes as good news for over 72 million diabetics in India, more affordable diabetic care is finally here with Nectar Biopharma, a leading company specialising in generic formulations, launching the generic version of vildagliptin, one of the most widely prescribed drugs, the patent for which had expired on December 9. Chandigarh based Nectar Biopharma will sell vildagliptin, which is used to treat uncontrolled type 2 diabetes mellitus, under the brand name Galvilda and the combination drug containing vildagliptin and metformin under the brand name Galvildamet. Nectar Biopharma is among the first companies to come up with the generic version of vildagliptin since the expiry of the drug patent. Commenting on the development, Nectar Biopharma Executive Director Saurabh Goyal said, “Riding on the success of our generics business, we are looking to garner a 5 per cent share in the Rs 1,500-crore market for vildagliptin and its combination drugs.” Nectar Biopharma’s portfolio includes innovative products in the therapeutic area of diabetes, like Gilmebest. The company is also working on a robust pipeline of generic formulations that have a high entry barrier. Nectar Biopharma is known for leading brands like Fivederm for skincare, Neclix and Necxon (cephalosporin antibiotics range) and Getnews Pregnancy Test. By means of its extensive Pan-India network of 450 distributors, 10,000 stockists and 2 lakh retailers spread over Tier 2 and 3 cities as well as metros, the company has made its products available all over the country through on-ground retail. Maintaining that vildagliptin would be prescribed to more and more patients as it gets cheaper in coming months, Goyal said, “Vildagliptin offers a high-volume and high-growth market where there is room for many good companies.” Despite being higher priced, vildagliptin is the second largest diabetes drug in terms of sales volumes with a market share of around 25 per cent of the dipeptidyl peptidase IV (DPP4) market since it is a better and safer formulation. ]]> <![CDATA[RDC India announces ISO compliance for Accu-Chek brand]]> https://biospectrumindia.com/news/95/15415/rdc-india-announces-iso-compliance-for-accu-chek-brand.html https://biospectrumindia.com/news/95/15415/rdc-india-announces-iso-compliance-for-accu-chek-brand.html Thu, 26 Dec 2019 07:45:00 +0530 Roche Diabetes Care (RDC) India announced that its Accu-Chek brand of blood glucose motoring products are compliant with the revised standards of IS/ISO 15197:2013 announced by Central Drugs Standard Control Organisation (CDSCO), Directorate General of Health Services, Ministry of Health & Family Welfare.  The original notification issued on 16 February 2016 stated that the revised IS/ISO 15197:2013 were to be effective after 36 months of its publication by Bureau of Indian Standards (BIS), which was stated to be October, 19, 2016. Given the 36-month period of transition the effective date for the implementation of IS/ISO 15197:2013 is now 18 October 2019. Using products that comply with the above mentioned standards will give confidence to people with diabetes that their meter gives most accurate readings of their blood glucose level, thereby enabling better management of their condition. ]]> <![CDATA[Lupin’s Ankleshwar facility wins Frost & Sullivan’s India manufacturing excellence awards 2019]]> https://biospectrumindia.com/news/95/15417/lupins-ankleshwar-facility-wins-frost-sullivans-india-manufacturing-excellence-awards-2019.html https://biospectrumindia.com/news/95/15417/lupins-ankleshwar-facility-wins-frost-sullivans-india-manufacturing-excellence-awards-2019.html Tue, 24 Dec 2019 17:00:00 +0530 Pharma major Lupin Limited announced that its Ankleshwar facility has been awarded “Future Ready Factory of the Year | Pharmaceutical Sector, Large Business,” by Frost & Sullivan’s India Manufacturing Excellence Awards (IMEA) 2019. The 2019 evaluation was done on the basis of an organisations’ Manufacturing Capability, Extended Supply Chain Reliability and Technology Adoption. On the occasion, Rajendra B Chunodkar, President — Manufacturing Operations, Lupin Limited said, “We are delighted to receive the award for Future Ready Factory of the Year. We strive to benchmark our manufacturing processes to the best practices in the world and we will continuously strive to get better and emerge successfully in a competitive market.”  IMEA was conceptualised with a mission “to recognise Indian Manufacturing capability and assess its global competitiveness” and has been the premier platform to identify Future Ready Factories in the country. The awards recognise best-in-class innovation, success stories and stellar performances exhibited in the manufacturing industry. ]]> <![CDATA[Mankind, Glenmark to co-market anti-diabetes drug in India]]> https://biospectrumindia.com/news/95/15403/mankind-glenmark-to-co-market-anti-diabetes-drug-in-india.html https://biospectrumindia.com/news/95/15403/mankind-glenmark-to-co-market-anti-diabetes-drug-in-india.html Tue, 24 Dec 2019 10:00:00 +0530 Mankind Pharmaceuticals Ltd. and Glenmark Pharmaceuticals Ltd. have inked a sub-licensing agreement to co-market sodium glucose co-transporter-2 (SGLT2) inhibitor, Remogliflozin Etabonate (Remogliflozin) in India. Under the agreement, Mankind will market the drug under its own trademark while Glenmark will manufacture and supply Remogliflozin to Mankind. In April 2019, Glenmark received approval from the Drugs Controller General of India (DCGI) for Remogliflozin Etabonate after successfully completing Phase-3 clinical trials. During the trials Remogliflozin demonstrated good efficacy and safety profile in a head-to-head comparison against Dapagliflozin. Subsequently, Glenmark launched Remogliflozin indicated in the treatment of Type 2 diabetes mellitus in adults under the brand names ‘Remo’ and ‘Remozen’. Remogliflozin has been launched at a breakthrough price that is significantly lower and cost-effective over other SGLT2 inhibitors available in the country. In fact, Remogliflozin is the only SGLT-2 inhibitor to be manufactured in India from an active pharmaceutical ingredient (API) to the formulation.   ]]> <![CDATA[Pneumococcal vaccine from SII achieves WHO prequalification]]> https://biospectrumindia.com/news/95/15398/pneumococcal-vaccine-from-sii-achieves-who-prequalification.html https://biospectrumindia.com/news/95/15398/pneumococcal-vaccine-from-sii-achieves-who-prequalification.html Tue, 24 Dec 2019 06:00:00 +0530 PNEUMOSIL®, a vaccine against a leading cause of deadly childhood pneumonia—the pneumococcus bacterium—has achieved prequalification by the World Health Organization (WHO). Developed through a collaboration spanning over a decade between Serum Institute of India, Pvt., Ltd. (SIIPL) and PATH and with funding from the Bill & Melinda Gates Foundation, the vaccine is expected to provide protection for children on par with other pneumococcal conjugate vaccines at a price that is more affordable for low- and middle-income countries. Prequalification allows PNEUMOSIL® to be procured by United Nations agencies and Gavi, the Vaccine Alliance. This news marks an important milestone toward alleviating one of the biggest barriers to sustainable access to pneumococcal conjugate vaccine that countries face—price. Dr. Rajeev Dhere, executive director of SIIPL said, “PNEUMOSIL® can be manufactured at high volume with current capacity at 100 million doses per annum, which will be augmented to over 150 million doses per annum in two to three years. It will be made available at a target Gavi price of around US$2 per dose, which is roughly 30% less than the current Gavi price for these kinds of vaccines.” Dr. Mark Alderson, director of PATH’s pneumococcal vaccine project explains, “The vaccine provides an alternate vaccine for low- and middle-income countries to ensure lifesaving access to pneumococcal disease prevention over the long term.” Pneumococcal conjugate vaccines have helped significantly reduce pneumococcal deaths and illness where introduced but are difficult for many countries to afford without considerable donor financial support. Although such support has been instrumental in helping to expand country access, implementing and sustaining pneumococcal vaccine programs continues to be difficult for many countries due to the vaccine price. PNEUMOSIL® addresses a need for a more affordable option that can make access easier for nations and free up country and donor funds for other health priorities. Dr Seth Berkley, CEO of Gavi, the Vaccine Alliance said, “There has been unprecedented demand for the pneumococcal vaccine from Gavi-supported countries. Within the last decade, we have supported the vaccination of 185 million children against this leading killer of children—but there is still work to be done. This new vaccine gives us more options in the fight to ensure no child dies from this preventable and treatable disease.” Dr. Keith Klugman, director of the pneumonia team at the Bill & Melinda Gates Foundation said, Vaccines are one of the best investments we can make to give every child a healthy start at life and build stronger communities and economies. As pneumonia continues to be the leading cause of death for young children worldwide, we welcome this new vaccine that will allow for more children to be protected from this debilitating disease.”  In addition to pneumonia, the pneumococcus bacterium causes other serious, life-threatening diseases like meningitis and sepsis. It is estimated to cause nearly 400,000 deaths in children under five years of age each year worldwide. PNEUMOSIL® covers the types of the bacterium most likely to cause serious illness in low- and middle-income countries. Its manufacturing process has been optimized to make it more efficient—reducing costs while preserving vaccine quality and making the vaccine a more affordable option for countries with the highest burdens of pneumococcal disease. Neeraj Jain, PATH country director in India said, “Pneumococcal conjugate vaccines are among the most complex vaccines to manufacture. As a vaccine developed and produced in India that will benefit the world, PNEUMOSIL®’s WHO prequalification is a landmark achievement.” Prior to WHO prequalification, a recent PATH-sponsored Phase 3 clinical study of PNEUMOSIL® in infants in The Gambia was conducted at the MRC Unit in The Gambia—part of the London School of Hygiene and Tropical Medicine. The study provided the pivotal results for the data package required for WHO prequalification. In the study, the vaccine met all primary and secondary endpoints with key findings showing the vaccine to have an acceptable safety profile and to generate a protective immune response similar to a WHO-prequalified comparator pneumococcal vaccine without interfering with other routine childhood immunizations. These results were presented at the 2019 European Symposium on Pediatric Infectious Diseases and a study manuscript is in preparation for peer-reviewed publication. Other study collaborators included FHI Clinical and the WHO Reference Laboratory for Pneumococcal Serology at the Great Ormond Street Institute of Child Health, University College London.   ]]> <![CDATA[Mankind Pharma & Glenmark collaborates for co-marketing of Remogliflozin Etabonate in India]]> https://biospectrumindia.com/news/95/15405/mankind-pharma-glenmark-collaborates-for-co-marketing-of-remogliflozin-etabonate-in-india.html https://biospectrumindia.com/news/95/15405/mankind-pharma-glenmark-collaborates-for-co-marketing-of-remogliflozin-etabonate-in-india.html Mon, 23 Dec 2019 13:35:00 +0530 Mankind Pharmaceuticals Ltd. and Glenmark Pharmaceuticals Ltd. have inked a sub-licensing agreement to co-market sodium glucose co-transporter-2 (SGLT2) inhibitor, Remogliflozin Etabonate (Remogliflozin) in India. Under the agreement, Mankind will market the drug under its own trademark while Glenmark will manufacture and supply Remogliflozin to Mankind. In April 2019, Glenmark received approval from the Drugs Controller General of India (DCGI) for Remogliflozin Etabonate after successfully completing Phase-3 clinical trials. During the trials Remogliflozin demonstrated good efficacy and safety profile in a head-to-head comparison against Dapagliflozin. Subsequently, Glenmark launched Remogliflozin indicated in the treatment of Type 2 diabetes mellitus in adults under the brand names ‘Remo’ and ‘Remozen’. Remogliflozin has been launched at a breakthrough price that is significantly lower and cost-effective over other SGLT2 inhibitors available in the country. In fact, Remogliflozin is the only SGLT-2 inhibitor to be manufactured in India from an active pharmaceutical ingredient (API) to the formulation. Dr Sanjay Koul , Director of Marketing, Mankind Pharma Ltd. said, “We are pleased to collaborate with Glenmark for the new anti-diabetic Remogliflozin because it provides a much-needed option to help adults with Type 2 diabetes to manage this disease. Mankind Pharma is committed to addressing some of the most pressing health problems faced by patients with cardiovascular and metabolic diseases, by identifying and mitigating specific risks. This is particularly important in reducing overall disease burden. Moreover, this strategic decision will not only strengthen our diabetes portfolio but also help consolidate our position as the fastest-growing player in the anti-diabetes segment. Remogliflozin is 50% economical than rest of the other similar agents currently available in SGLT-2 inhibitors class, which shall help for its better access among middle & low socio-economic strata of the society.” Sujesh Vasudevan, President, India Formulations, Middle East and Africa at Glenmark Pharmaceuticals said, “Our collaboration with Mankind demonstrates our commitment towards providing novel, innovative treatment options for efficient diabetes management. Our partnership with Mankind is an important milestone in our strategy to widen patients’ access to the latest, novel and globally-researched SGLT2 inhibitor, Remogliflozin in India and will provide a strong foundation for a long-term collaboration with Mankind for Remogliflozin.” Remogliflozin, a selective sodium-glucose co-transporter subtype 2 (SGLT2) inhibitor, which is to be administered as remogliflozin etabonate, the prodrug for remogliflozin, recently received its first approval as a treatment for type 2 diabetes mellitus in India. Glenmark secured certain rights to Remogliflozin through a licensing collaboration agreement with a subsidiary of Avolynt, Inc. which is based in North Carolina, USA, and conducted the Phase-3 clinical trial, which included the largest number of Indian patients tested for any SGLT2 inhibitor. ]]> <![CDATA[Panacea Biotec receives $24.32M award from UN Agencies]]> https://biospectrumindia.com/news/95/15395/panacea-biotec-receives-24-32m-award-from-un-agencies.html https://biospectrumindia.com/news/95/15395/panacea-biotec-receives-24-32m-award-from-un-agencies.html Mon, 23 Dec 2019 09:45:00 +0530 New Delhi based biotechnology company Panacea Biotec has received Awards worth USD 24.32 Million (Over Rs.170 crores) from U.N. Agencies (UNICEF and PAHO) for supply of its Easyfive-TT, a fully liquid WHO prequalified Pentavalent Vaccine. UNICEF award is for year 2020 and award of PAHO is for three (3) years i.e. 2020-2022. Pediatric vaccination plays an important role to achieve Sustainable Development Goals set by the United Nations, in particular the target to reduce under-five mortality rate to less than 25 per 1000 live births. Pentavalent vaccine protects children against five deadly diseases; Diphtheria, Tetanus, Pertussis, Hepatitis B and invasive infections caused by Haemophilus Influenza Type b – becoming the foundation of paediatric immunization programs across the world. Easyfive-TT (DTwP-HepB-Hib) was introduced by Panacea Biotec as world’s first fully liquid wP-based pentavalent vaccine in Indian market in 2005. With WHO prequalification in 2008, over 100 million doses have been supplied to more than 50 countries globally. Easyfive-TT is ready for use without further preparation by healthcare workers in the field, which offers major healthcare advantages in countries with challenging infrastructure and hygiene problems. Panacea Biotec has contributed significantly for Children’s Health and has partnered with WHO, UNICEF & PAHO in their efforts to maximize coverage of vaccines under the Expanded Program on Immunization (EPI) in developing countries. The Company has pioneered in development of wP based fully-liquid combination vaccines and has launched: Ecovac (Diphtheria, Wholecell Pertussis, Tetanus, Hepatitis B), Easyfour (Diphtheria, Wholecell Pertussis, Tetanus and Hib), Easyfive-TT (Diphtheria, Whole cell Pertussis, Tetanus, Hepatitis B and Hib), Easysix (Diphtheria, Whole cell Pertussis, Tetanus, Hepatitis B, Hib and IPV) – the world’s first and only wP-IPV hexavalent vaccine) to meet to  programmatic needs of evolving immunization programs. As a responsible and reliable partner, Panacea Biotec thus contributes to the success of the Global Alliance for Vaccines and Immunization (GAVI Alliance) in accelerating access to these vaccines across the globe. Dr. Rajesh Jain, Managing Director, commented, “I have always believed that innovation delivers sustainable business value and we are glad to witness the same once again.  We are re-building on our deep-rooted foundation in biological business and would like to congratulate all our team members, employees, shareholders and other stakeholders. We look forward with confidence and conviction about our performance year after year.” ]]> <![CDATA[Lupin set to market Betamethasone Dipropionate Ointment ]]> https://biospectrumindia.com/news/95/15392/lupin-set-to-market-betamethasone-dipropionate-ointment-.html https://biospectrumindia.com/news/95/15392/lupin-set-to-market-betamethasone-dipropionate-ointment-.html Fri, 20 Dec 2019 16:35:00 +0530 Pharma major Lupin Limited (Lupin) announced that it has received approval for its Betamethasone Dipropionate Ointment USP (Augmented), 0.05%, from the United States Food and Drug Administration (U.S. FDA), to market a generic equivalent of Diprolene® Ointment, 0.05%, of Merck Sharp and Dohme Corp. The product will be manufactured at Lupin’s Pithampur (Unit 3) facility, India.  Betamethasone Dipropionate Ointment USP (Augmented), 0.05%, is a corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses in patients 13 years of age and older.  Betamethasone Dipropionate Ointment USP (Augmented), 0.05%, (RLD: Diprolene®) had an annual sales of approximately USD 22 million in the U.S. (IQVIA MAT September 2019). ]]> <![CDATA[Merck gets FDA approval for Ebola vaccine]]> https://biospectrumindia.com/news/95/15389/merck-gets-fda-approval-for-ebola-vaccine.html https://biospectrumindia.com/news/95/15389/merck-gets-fda-approval-for-ebola-vaccine.html Fri, 20 Dec 2019 12:00:00 +0530 The U.S. Food and Drug Administration has announced the approval of Ervebo, the first FDA-approved vaccine for the prevention of Ebola virus disease (EVD), caused by Zaire ebolavirus in individuals 18 years of age and older. Cases of EVD are very rare in the U.S., and those that have occurred have been the result of infections acquired by individuals in other countries who then traveled to the U.S., or health care workers who became ill after treating patients with EVD. EVD is contagious and is transmitted through direct contact with blood, body fluids and tissues of infected wild animals or people, as well as with surfaces and materials, such as bedding and clothing, contaminated with these fluids. Onset of symptoms of EVD can be sudden and can include fever, fatigue, muscle pain, headache and sore throat. This is followed by vomiting, diarrhea, rash, impaired kidney and liver function and in some cases internal and external bleeding. EVD has an incubation period that ranges from 2 to 21 days. Individuals who provide care for people with EVD, including health care workers who do not use correct infection control precautions, are at the highest risk for infection.  “Ebola virus disease is a rare but severe and often deadly disease that knows no borders. Vaccination is essential to help prevent outbreaks and to stop the Ebola virus from spreading when outbreaks do occur,” said Peter Marks, M.D., Ph.D., director of the FDA’s Center for Biologics Evaluation and Research. “The FDA’s approval of Ervebo is a major advance in helping to protect against the Zaire ebolavirus as well as advancing U.S. government preparedness efforts. The research approach used to study the effectiveness and safety of this vaccine was precedent-setting during a public health emergency and may help create a model for future studies under similar circumstances. The FDA is committed to continuing our work across the U.S. government and with our international partners to prevent future Ebola outbreaks and mitigate the current outbreak in the DRC, reflecting our nation’s commitment to preparing for and responding to biological threats, like Ebola.” Ervebo is administered as a single-dose injection, and is a live, attenuated vaccine that has been genetically engineered to contain a protein from the Zaire ebolavirus. The FDA granted this application Priority Review and a Tropical Disease Priority Review Voucher under a program intended to encourage development of new drugs and biologics for the prevention and treatment of certain tropical diseases. The FDA also granted Breakthrough Therapy designation for Ervebo to facilitate the development and scientific evaluation of the vaccine. Because of the public health importance of a vaccine to prevent EVD, the FDA worked closely with the company and completed its evaluation of the safety and effectiveness of Ervebo in less than six months. The approval was granted to Merck & Co., Inc ]]> <![CDATA[Glenmark Pharmaceuticals announces product approval for Ryaltris® in Australia]]> https://biospectrumindia.com/news/95/15382/glenmark-pharmaceuticals-announces-product-approval-for-ryaltris-in-australia.html https://biospectrumindia.com/news/95/15382/glenmark-pharmaceuticals-announces-product-approval-for-ryaltris-in-australia.html Fri, 20 Dec 2019 11:00:00 +0530 Glenmark Pharmaceuticals has announced that Seqirus Pty. Ltd. (Seqirus) has received marketing approval for Ryaltris® from the Therapeutic Goods Administration (TGA), Australia. This paves the way for the launch of Ryaltris® in Australia through the partner, Seqirus. Australia will be the first market globally where Ryaltris® will be launched. Seqirus, part of Australia-based specialty biotechnology company CSL Ltd., entered into an exclusive licensing agreement in July 2018 with Glenmark's subsidiary Glenmark Specialty S.A. to commercialize Ryaltris® in Australia. Ryaltris® is a new fixed-dose combination nasal spray of an antihistamine and a steroid, indicated for treatment of symptoms associated with allergic rhinitis (AR) and rhinoconjunctivitis in patients over 12 years of age. Under the terms of the agreement, Glenmark will be responsible for product supply and Seqirus will be responsible for regulatory filing and commercialization of the product in Australia. Glenmark is entitled to receive commercial milestone payments from Seqirus. Ryaltris® will be manufactured at Glenmark's Baddi manufacturing facility, Himachal Pradesh, India. Australia has one of the world's highest rates of allergic rhinitis with nearly 20% of the country's population suffering annually from this disease. Allergic rhinitis can lead to a reduction in quality of life and functional impairment. Glenn Saldanha, Chairman and Managing Director of Glenmark Pharmaceuticals said, "We are delighted to receive an approval from TGA for Ryaltris® through our partner Seqirus to commercialize Ryaltris® in Australia. Seqirus' strong presence in allergy in this market makes them an ideal partner for Glenmark.” Dr. Lorna Meldrum, Seqirus' VP Asia Pacific Commercial Operations said, "We are very excited to be working with Glenmark on the distribution, marketing and sales of their novel fixed dose combination product for allergic rhinitis. Ryaltris® is an important addition to Seqirus' growing product range and strengthens our broad portfolio of in-licensed pharmaceuticals and vaccines in Australia.” Glenmark plans to commercialize Ryaltris® in several key markets globally. Glenmark will explore commercial partnerships for Ryaltris® in markets where it doesn't have direct presence. ]]> <![CDATA[Lupin’s Alliance Partner Concord receives approval for Mycophenolic Acid Delayed Release Tablets ]]> https://biospectrumindia.com/news/95/15381/lupins-alliance-partner-concord-receives-approval-for-mycophenolic-acid-delayed-release-tablets-.html https://biospectrumindia.com/news/95/15381/lupins-alliance-partner-concord-receives-approval-for-mycophenolic-acid-delayed-release-tablets-.html Fri, 20 Dec 2019 10:50:00 +0530 Lupin in alliance with Concord Biotech Limited (Concord) announced that it has received approval from the United States Food and Drug Administration (U.S. FDA) for Mycophenolic Acid Delayed-Release Tablets USP, 180 mg and 360 mg, to market the generic equivalent of Myfortic® Delayed-Release Tablets, 180 mg and 360 mg, of Novartis Pharmaceuticals Corporation. Mycophenolic Acid Delayed-Release Tablets USP, 180 mg and 360 mg, are indicated for: Prophylaxis of organ rejection in adult patients receiving kidney transplants and in pediatric patients at least 5 years of age and older who are at least 6 months post kidney transplant. Use in combination with cyclosporine and corticosteroids. Mycophenolic Acid Delayed-Release Tablets USP, 180 mg and 360 mg (RLD: Myfortic®) had an annual sales of approximately USD 174 million in the U.S. (IQVIA MAT September 2019). ]]> <![CDATA[Fermenta Biotech announces merger with DIL]]> https://biospectrumindia.com/news/95/15383/fermenta-biotech-announces-merger-with-dil.html https://biospectrumindia.com/news/95/15383/fermenta-biotech-announces-merger-with-dil.html Fri, 20 Dec 2019 10:25:00 +0530 Thane based biotech company Fermenta Biotech has announced that  the  Indian  courts  recently  approved  the  merger  of  the  company,  Fermenta  Biotech  Limited  (‘FBL’),  with   its   parent   company,   DIL   Limited (‘DIL’), which  held  91.20%  of  the  equity  share  capital  of  FBL.  Post  the  merger,  the  control and management of the company, remain unchanged. Also,  as  a  result,  DIL  has  been   renamed   as   Fermenta   Biotech   Limited.   The company has  highlighted  that  this  merger  brings  together  the  rich  asset  base  of  DIL  and  the strong  operational  business  of  FBL  into  a  single  entity,  thereby   strengthening   the company's  balance sheet and cashflows further.     ]]> <![CDATA[Lupin launches Doxercalciferol Injection ]]> https://biospectrumindia.com/news/95/15376/lupin-launches-doxercalciferol-injection-.html https://biospectrumindia.com/news/95/15376/lupin-launches-doxercalciferol-injection-.html Thu, 19 Dec 2019 15:25:00 +0530 Lupin announced the launch of Doxercalciferol Injection, 4 mcg/2 mL (2 mcg/mL) Multi-dose Vials, having received an approval from the United States Food and Drug Administration (U.S. FDA) earlier. Lupin’s Doxercalciferol Injection, 4 mcg/2 mL (2 mcg/mL) Multi-dose Vials, is the therapeutic generic equivalent of Sanofi Genzyme’s Hectorol® Injection, 4 mcg/2 mL (2 mcg/mL) Multi-dose Vials. It is indicated for the treatment of secondary hyperparathyroidism in adult patients with CKD on dialysis. Doxercalciferol Injection, 4 mcg/2 mL (2 mcg/mL) Multi-dose Vials, (RLD: Hectorol®) had an annual sales of approximately USD 132 million in the U.S. (IQVIA MAT October 2019). ]]> <![CDATA[Glenmark's Baddi facility gets GMP certificate from European regulator]]> https://biospectrumindia.com/news/95/15371/glenmarks-baddi-facility-gets-gmp-certificate-from-european-regulator.html https://biospectrumindia.com/news/95/15371/glenmarks-baddi-facility-gets-gmp-certificate-from-european-regulator.html Thu, 19 Dec 2019 11:30:00 +0530 Glenmark Pharmaceuticals has announced that its Baddi manufacturing unit has received Good Manufacturing Practice (GMP) certificate from European regulator State Institute for Drug control (SUKL).  Glenmark Pharmaceuticals said in statement that, “The European regulator has just issued a certificate of compliance for the facility stating that it complies with the principles and guidelines of Good Manufacturing Practice laid down in the directive 2003/94/EC which stipulates the requirements to fulfil GMP recommendations of WHO.”  “Baddi manufacturing unit of Glenmark Pharmaceuticals was inspected by the leading European regulator, SUKL (State Institute for Drug control), Czech Republic in the week of Oct 21, 2019.”The company statement added.   ]]> <![CDATA[IDBS expands operations in India to capitalize on R&D growth]]> https://biospectrumindia.com/news/95/15360/idbs-expands-operations-in-india-to-capitalize-on-rd-growth.html https://biospectrumindia.com/news/95/15360/idbs-expands-operations-in-india-to-capitalize-on-rd-growth.html Thu, 19 Dec 2019 07:00:00 +0530 IDBS, a software informatics solution provider for biotech and pharma, has expanded its global reach in India and made two strategic hires in the region. The latest move by the firm is in response to growing demand and an expanding customer base in the region. R&D spending in India is expected to reach US$94 billion in 2020, up from US$86 billion in 2019 and the country is now the third largest pharma sector globally. As R&D firms look to innovate to meet demand, IDBS believes there is a strong opportunity for its cloud data management software solution, The E-Workbook Cloud, to help build paperless, flexible and scalable labs. To manage the firm’s market presence in India, IDBS has appointed Manish Manakchand as Commercial Director and Braj Thakur as National Sales Manager. Manakchand joins the firm from a five-year period as Senior Global Marketing Manager for the Global Business Unit at Beckman Coulter Life Sciences, part of Danaher. Thakur joins from Laurus Infosystems, where he was Head of Sales and Marketing. Both will report into Christian Marcazzo, General Manager at IDBS. “IDBS’ digital technologies have set the standard in scientific informatics solutions,” Manakchand commented. “I am excited about helping customers in India to transform their data management processes, reduce their time to market, as well as their time to value.” Marcazzo said: “These new appointments come at a time of rapid growth in the biologics and preclinical markets, alongside the increased use of third-party contract research organizations in India – mirroring the global trend. As these firms seek to discover and develop new therapeutics, the adoption of transformative technologies that streamline data management and facilitate collaboration with partners is essential.” The E-Workbook Cloud provides enterprise-wide scientific data management to pharmaceutical, biotech, and other R&D firms working across the fields of biologics, drug discovery and development. The platform, which can be deployed via the cloud or on-premise in both GxP and non GxP environments, allows firms to capture, manage, share and gain insight from their data. IDBS also provides configured solutions for specific verticals. This includes the IDBS Bioprocess Solution, which optimises workflows across people, equipment and data sources throughout the development lifecycle. Marcazzo added: “The combination of IDBS’ expertise in enterprise scientific informatics platforms and Danaher’s business systems and global reach will be a driver of long-term growth and innovation for our customers in the life sciences markets in India.” IDBS is owned by Fortune 500 science and technology corporation, Danaher. It is part of Danaher’s Life Sciences division, which also incudes Beckman Coulter Life Sciences, Pall Corporation and Sciex.   ]]> <![CDATA[Hetero launches 3-in-1 single pill for HIV treatment]]> https://biospectrumindia.com/news/95/15369/hetero-launches-3-in-1-single-pill-for-hiv-treatment.html https://biospectrumindia.com/news/95/15369/hetero-launches-3-in-1-single-pill-for-hiv-treatment.html Thu, 19 Dec 2019 07:00:00 +0530 Hetero, one of India’s leading generic pharmaceutical companies and the world’s largest producer of antiretroviral drugs,  announced the launch of the latest 3-in-1 antiretroviral combination drug under the brand name ‘TAFFIC’ in India. The product ‘TAFFIC’ is the generic version of Gilead’s Biktarvy® and has been approved by the Drug Controller General of India (DCGI). The product will be marketed and distributed by Hetero Healthcare Ltd. in India. TAFFIC, a once-a-day single pill, is a combination of three medicines – Bictegravir (50mg), Emtricitabine (200mg), and Tenofovir Alafenamide (25mg). The product is indicated for the treatment of human immunodeficiency virus type (HIV-1) infection in adults who have no antiretroviral treatment history or replacing the current antiretroviral regimen in those who have viral copies less than 50 per ml in the blood at least for three months with no prior treatment failure and resistance to any components. The 3-in-1 combination drug helps to prevent HIV from multiplying and works together to decrease the amount of HIV in the patient’s blood to undetectable levels. This lowers the prospects of patients developing various HIV associated illnesses, thereby improving their quality of life. Studies suggest that the combination of Bictegravir, Emtricitabine, and Tenofovir Alafenamide has shown high antiviral efficacy and safety profile in HIV patients. TAFFIC is manufactured in Hetero’s world-class manufacturing facility in Hyderabad, India, which is approved by international regulatory bodies. Hetero is recognized as a leader in ARVs with a product portfolio of over 30 drugs and is committed to the cause of alleviating HIV/AIDS for more than two decades. The launch of this product emphasizes Hetero’s ongoing commitment to provide advanced and effective treatments to HIV patients worldwide. To further this mission, Hetero will be making the latest combination drug available in 116 low and middle-income countries and is subject to approvals from the regulatory authorities in these countries. ]]> <![CDATA[Ziqitza Healthcare bags two prestigious healthcare Awards]]> https://biospectrumindia.com/news/95/15366/ziqitza-healthcare-bags-two-prestigious-healthcare-awards.html https://biospectrumindia.com/news/95/15366/ziqitza-healthcare-bags-two-prestigious-healthcare-awards.html Wed, 18 Dec 2019 12:25:00 +0530 Ziqitza Healthcare Ltd ( ZHL), Asia's largest private medical service provider company, recently bagged the two most significant awards in the healthcare industry - 'Best Post-Crash Service' at the FICCI Road Safety Awards 2019  and the Healthcare Excellence Award for 'Integrated referral transport Ambulance Service in Madhya Pradesh' at the Elets Annual Healthcare Excellence Awards 2019. FICCI Road Safety Awards is designed for creating awareness among people about the need and essence of road safety alongside identifying common causes of road accidents & fatalities and derive possible solutions offered by industry. The prestigious award was conferred in New Delhi by Shri Baijayant Jay Panda, National Vice President, and Spokesperson, Bhartiya Janta Party. Ziqitza rightly fitting into the title, has been providing relentless and timely support to the victims, ZHL alone has helped save more than 22 million lives, and have attended to more than 4 lakh accidents cases to date in the said regions. The jury also appreciated the fact that ZHL has not only used ambulances to save lives but also trained over 3.33 lakh bystanders in first aid training who are equipped to act at the time of road accidents and increase the survival rate within the Golden Hour. Elets Healthcare Innovation Summit and Annual Healthcare Excellence Awards 2019 celebrate the excellence in Healthcare and felicitate healthcare providers for their critical contributions and services to the industry. The recognition for ZHL's continuous efforts - the Integrated referral transport Ambulance Service in MP was presented by Mr. S.R Marak, Additional Resident Commissioner, Government of Meghalaya and Ms. Padma Jaiswal, Secretary, Directorate of IT, Government of Puducherry. This award recognized that the EMS service provided by ZHL in the state, has served 12196963 people via a network of 606 ambulances, 150 MMU's (Mobile Medical Units) and 350 number of Call Centre Executives. The services can be availed by dialling a single number of Dial-in 108 for an Ambulance for a medical emergency, Ambulance for pregnant women, health helpline for medical queries and Mobile Medical Unit. The event was well attended by stalwarts in the health care industry - Mr. Ashwini Kumar Choubey, Hon'ble Minister of State for Health & Family Welfare, Government of India; Mr. Jai Pratap Singh, Hon'ble Minister, Medical and Health, Family Welfare, Mother and Child Welfare, Government of Uttar Pradesh amongst other health policymakers and experts. Commenting proudly on the win, Mr. Naresh Jain, CEO, Ziqitza Healthcare Ltd said, "We thank FICCI and Elets for recognising us and our efforts in India. Such awards and recognition work as an added booster to organisations that work towards the wellbeing of the society. This win is dedicated to the entire workforce of Ziqitza Family that goes beyond the call of duty and serves the society. We are also thankful to the state governments who have given us this opportunity to serve people and our private partners for always believing in our work. We want to continue with our commitment to meeting international standards of quality in Emergency Medical Services and be accessible to all people regardless of their income." ]]> <![CDATA[Excelra enters into Drug Repurposing partnership with Keio University]]> https://biospectrumindia.com/news/95/15365/excelra-enters-into-drug-repurposing-partnership-with-keio-university.html https://biospectrumindia.com/news/95/15365/excelra-enters-into-drug-repurposing-partnership-with-keio-university.html Wed, 18 Dec 2019 12:05:00 +0530 Hyderabad based Excelra, a leading global Data and Analytics company, has announced a Drug Repurposing partnership with Keio University School of Medicine – a top research university in Japan, to explore new therapeutics for a rare indication. Under the agreement, a team of chemo-informaticians and data scientists at Excelra will collaborate with Dr. Toshiki Takenouchi, Assistant Professor of Paediatrics, to identify drugs with activity against a key target in the Takenouchi-Kosaki syndrome. The Takenouchi-Kosaki syndrome is a highly heterogenous autosomal complex congenital developmental disorder affecting multiple organ systems. Excelra's scientists will leverage its proprietary Global Integrated Drug Repurposing Platform, comprising comprehensive repurposing databases, repurposing algorithms, analytics tools and visualization engines to expand the utility of approved drugs. The database within the Drug Repurposing Platform has been built by amassing chemical data (over 7 million chemical entities), biological data and clinical data (over 200,000 data points), together contributing to more than 10 million associations among 'drug-disease-target' triads. Dr. Nandu Gattu, Senior Vice President, Pharma Analytics, Excelra, said, "Drug Repurposing is an attractive strategy to reduce the cost of developing new therapies by tapping into the repertoire of approved drugs with a known safety profile. It is our privilege to work with Dr. Takenouchi in this endeavour to explore the therapeutic potential of existing drugs for a rare disease." ]]> <![CDATA[Kerala CM visits Pranex centre of Terumo in Japan]]> https://biospectrumindia.com/news/95/15345/kerala-cm-visits-pranex-centre-of-terumo-in-japan.html https://biospectrumindia.com/news/95/15345/kerala-cm-visits-pranex-centre-of-terumo-in-japan.html Wed, 18 Dec 2019 10:05:00 +0530 As part of his ongoing 11-day trip to Japan and South Korea, Kerala CM P Vijayan recently visited Japanese health care giant Terumo’s Pranex and R&D Centre in Nakai Machi, Kanagawa, Japan. Terumo Pranex Centre is a training facility that recreates the functions of actual hospitals and helps in training of medical professionals. It trains medical professional in specialized knowledge and skills while nurturing their situational judgment capabilities, leadership and communication skills, along with other non-technical skills. P Vijayan said, “I am happy to learn about activities and facilities of Pranex, as training is an essential pillar for development and improvement of the skill set of medical practitioners.” The Chief Minister also invited Terumo Corporation, to invest in the Life Sciences Park in Kerala and partner with the state in establishing a Skill Centre for training health care professionals. He assured that the Government will provide the infrastructure necessary to house the center. This would be advantageous for Terumo, he said, since the company already has a large manufacturing facility and R&D centre in Thiruvananthapuram which has grown firmly over the past 20 years. Developing a pranex centre in the country will be beneficial in developing the skill set of medical practitioners in India and eventually will help in attaining the Prime Minister’s vision of Healthy India under Ayushman Bharat. Moreover, Kerala had emerged as the top-ranking state in terms of overall health performance, according to second health index launched by NITI Aayog in 2019; hence the value addition to the Indian health sector can be immense once the centre becomes operational. Chandrasekhar Padmakumar, Chairman of Terumo Penpol mentioned, “It is an honour for Terumo to host the Chief Minister of Kerala and showcase the Pranex Centre in Japan; the state government have been very supportive over the years  in our journey and we are thankful to him for extending his support in developing a Pranex centre in Kerala. The visit to the Pranex Centre helped the delegation led by the CM have a firsthand experience of how medical professionals can acquire a wider range of more specialized knowledge and non-technical skills like situational judgment capabilities, leadership, communication skills, and teamwork.” The Chief Minister was accompanied by E P Jayarajan, Minister for Industries; A K Saseendran, Minister for Transport,; Tom Jose, Chief Secretary; Dr K Ellangovan, Principal Secretary Industries; Dr Usha Titus Principal Secretary Higher Education and Environment, and Mona Khandhar, Minister (Economic), Embassy of India, Tokyo. ]]> <![CDATA[Gilead announces NASH combo results from Phase 2 ATLAS Study ]]> https://biospectrumindia.com/news/95/15341/gilead-announces-nash-combo-results-from-phase-2-atlas-study-.html https://biospectrumindia.com/news/95/15341/gilead-announces-nash-combo-results-from-phase-2-atlas-study-.html Tue, 17 Dec 2019 10:50:00 +0530 Gilead Sciences has announced topline results from the 48-week, Phase 2 ATLAS study of combination and monotherapy investigational treatments for advanced fibrosis (F3-F4) due to NASH. While no regimen led to a statistically significant increase in the proportion of patients who achieved the primary efficacy endpoint of a ≥1-stage improvement in fibrosis without worsening of NASH, statistically significant improvements in multiple response measures of fibrosis and liver function were observed in patients treated with a combination of the acetyl-CoA carboxylase (ACC) inhibitor firsocostat and the selective, nonsteroidal farnesoid X receptor (FXR) agonist cilofexor, compared with placebo in patients with advanced fibrosis. The Phase 2 ATLAS study is a randomized, double-blind, placebo-controlled study that evaluated the safety and efficacy of monotherapy and dual combination regimens of cilofexor 30 mg, firsocostat 20 mg and selonsertib 18 mg in patients with advanced fibrosis (F3-F4) due to NASH. The selonsertib monotherapy treatment group was discontinued following termination of the previously reported STELLAR trials of selonsertib. Statistically significant improvements in multiple secondary endpoints were observed in patients treated with firsocostat and cilofexor compared with placebo, including a ≥2-point reduction in the NAFLD Activity Score (NAS) and ≥1-point reductions in steatosis, hepatocellular ballooning and lobular inflammation. Statistically significant improvements in noninvasive tests of fibrosis, liver injury and function, including ALT, AST, bilirubin and ELF score, were also observed in patients treated with this regimen compared with placebo. Firsocostat, cilofexor and selonsertib, as monotherapies and dual combination regimens, were generally well tolerated. Further results from the ATLAS study will be presented at an upcoming scientific conference. “NASH is a complex disease driven by multiple mechanisms. The results from the ATLAS study suggest the potential for a combination therapeutic approach for patients with advanced fibrosis by targeting different aspects of this disease,” said Merdad Parsey, MD, PhD, Chief Medical Officer, Gilead Sciences. “We continue to analyze the ATLAS data and will work with regulators to determine appropriate next steps for these therapies.” “This trial provides novel data showing consistent improvements in liver histology and noninvasive tests, demonstrating the value of a combination approach to deliver meaningful changes in fibrosis, the key determinant of disease severity in NASH,” said Rohit Loomba, MD, MHSc, Director of NAFLD Research Center and Director of Hepatology, University of California, San Diego. Cilofexor, firsocostat and selonsertib, alone or in combination, are investigational compounds and are not approved by the U.S. Food & Drug Administration (FDA) or any other regulatory authority. Safety and efficacy have not been established for these agents. ]]> <![CDATA[Cipla acquires trademark rights of Vysov ]]> https://biospectrumindia.com/news/95/15337/cipla-acquires-trademark-rights-of-vysov-.html https://biospectrumindia.com/news/95/15337/cipla-acquires-trademark-rights-of-vysov-.html Tue, 17 Dec 2019 10:05:00 +0530 Cipla has acquired the brand name and trademark rights for Vysov ® & Vysov M® (Vildagliptin + Metformin) of the anti-diabetic drug, Vildagliptin for the Indian market. The company has been co-marketing Vildagliptin in agreement with Novartis under brand names Vysov® & Vysov M® and has witnessed a strong uptake for the product in India for the last couple of years. It is currently available across the country. Vildagliptin is an orally active, potent and selective DPP-4 inhibitor that improves glycemic control in patients primarily by enhancing pancreatic (α and β) islet functions. The drug is backed by strong clinical data & is therefore a widely prescribed antidiabetic medicine for adults with type 2 diabetes mellitus. Nikhil Chopra, Executive Vice-President & Head India Business, Cipla Ltd. said “Owing to the increased affordability of Vildagliptin it is more accessible for better management of the disease. Cipla’s acquisition of the trademark rights of Vysov® will enable us to contribute to easier access of the drug in India.” The current market size of Vildagliptin is INR 818 Cr. as per IQVIA MAT Nov’ 2019 in India.   ]]> <![CDATA[Healthcare textile firm MIP enters India]]> https://biospectrumindia.com/news/95/15334/healthcare-textile-firm-mip-enters-india.html https://biospectrumindia.com/news/95/15334/healthcare-textile-firm-mip-enters-india.html Tue, 17 Dec 2019 06:05:00 +0530 Global leader in reusable healthcare textile industry, MIP Inc., was launched in India recently by Tor Lund, President and CEO of MIP Inc. and Bollywood actor Ameesha Patel in Delhi.  MIP Inc. has come to India after being in the business of reusable healthcare textiles for the last 40 years. MIP started its journey in 1977 from Canada. It is a manufacturer and distributor of high performance textile and related products to healthcare facilities and distributors and outsourced laundry service providers. It has manufacturing facilities in Quebec, China and Germany. The brand is worth Canadian Dollar $115 million. Speaking at the launch, Tor Lund said, “This is an exciting time for MIP as the brand has experienced strong growth in revenue and market share across the globe. Having make our presence felt it in Canada, US, UK and Europe, we felt this was an opportune time to enter the growing Indian healthcare sector. With a proud history of supplying quality products and providing outstanding service we have a long-term strategy for India. We wish our employees and stake-holders in India the very best.” Adding her views, Ameesha Patel, said, “I am happy to be here at the start of MIP Inc. India journey. It is a well-recognized brand and a leader in its segment and I believe that they will revolutionize the reusable healthcare textile segment in India.”  On what motivated MIP to enter the Indian market now, Tor said, “The Indian health care market is growing rapidly and increasingly becoming more sophisticated and we have had the fortune of teaming up with a local team that has the passion, dedication, knowledge as well as shared values with the MIP culture. In addition, there seems to be an increasing need for high quality textile products that support the world class medical infrastructure and expertise that currently exists.” On what the brand hopes to achieve in its first year of operations in India, Tor added, “We hope to have our products used in 20 private as well as public hospitals and that these will serve as showcases and proof of concept for further growth in 2021 and beyond.” The company now in India aims to power the healthcare segment with effective, affordable and quality healthcare textile products.    ]]> <![CDATA[Sai Life Sciences to develop into New Gen CDMO]]> https://biospectrumindia.com/news/95/15326/sai-life-sciences-to-develop-into-new-gen-cdmo.html https://biospectrumindia.com/news/95/15326/sai-life-sciences-to-develop-into-new-gen-cdmo.html Mon, 16 Dec 2019 09:45:00 +0530 Hyderabad based Sai Life Sciences, one of India's fastest growing Contract Development & Manufacturing Organizations (CDMOs), has announced Sai Nxt, an organization-wide initiative aimed at transforming the company into a new generation CDMO. Guided by the insights and feedback from its customers, the company is investing upwards of US $ 150 million over the period between 2019 and 2023 as a part of Sai Nxt, with a focus on three key areas – People & culture Processes & automation Infrastructure & scientific capabilities Making the announcement, Krishna Kanumuri, CEO & Managing Director of Sai Life Sciences said, "Sai Nxt marks a transformative phase in our journey. Our growth over the years has essentially been driven by our scientific capabilities and customer focus. Raising the bar further, Sai Nxt will help us better serve the growing demand from global innovator pharma and biotech companies for speed and flexibility, with an assurance of compliance and dependability." Built on the foundation of partnership, Sai Life Sciences has grown to become one of India's most trusted CDMOs. Coinciding with the completion of 20 years since its inception, Sai Nxt is the transformative lever aimed to propel the organization in the next phase of its growth. Sai Nxt initiatives (illustrative)  People & Culture:Expanding scientific talent pool, inducting top-notch global scientific and leadership talent, role-based integrated online training, shop floor transformation, nurturing culture of excellence Processes & Automation: Process simplification, strengthening governance systems, electronic manufacturing records, IT systems integration, foundation for seamless data capture across operations, leveraging latest technologies (RPA, IOT, AI / ML, AR/ VR) for innovation and intelligence Infrastructure & Capabilities:Biology lab in Cambridge (MA, USA), Process R&D lab in Manchester (UK), Integrated Discovery and Development campus, expanded suite of technology platforms, early phase delivery facility, flexible manufacturing with 2.5x capacity, advanced safety & quality systems Through Sai Nxt, the company aims to significantly expand and upgrade its R&D and manufacturing facilities, deepen scientific & technological capabilities, strengthen automation and data systems, and above all raise the bar for safety, quality and customer focus. ]]> <![CDATA[Zydus unveils affordable oral anti-diabetic tablet Vinglyn]]> https://biospectrumindia.com/news/95/15310/zydus-unveils-affordable-oral-anti-diabetic-tablet-vinglyn.html https://biospectrumindia.com/news/95/15310/zydus-unveils-affordable-oral-anti-diabetic-tablet-vinglyn.html Wed, 11 Dec 2019 17:25:00 +0530 Zydus Cadila takes yet another step towards diabetes care with the launch of an affordable oral anti-diabetic agent, Vinglyn (Vildagliptin) & Vinglyn M (Vildagliptin plus metformin). The drug belongs to the class of oral anti-diabetic agents, known as DPP4 inhibitors, which have shown promise in achieving glycaemic control without deterioration in beta cell function and are one of the recent advancements in diabetes care and management. Vinglyn and Vinglyn M will be marketed by Zydus Healthcare Ltd. Priced at just Rs 4.95 per tablet, which is almost 1/6th the price at which the patented Vildagliptin was initially launched in India, Vinglyn is now one of the most affordable brands of Vildagliptin for diabetic patients in India. Commenting on the launch, Dr. Sharvil Patel, Managing Director, Zydus Cadila, said, "Diabetes is becoming a major health burden globally. Fortifying our fight against diabetes, our aim is to make therapies affordable and accessible to patients from across sections of society. With Vinglyn, we believe that we have once again been able to offer this. The access to one of the most affordable gliptin therapies will help a large number of patients suffering from Type II diabetes, in India.” ]]> <![CDATA[Novartis gets FDA filing acceptance of Xolair® to treat nasal polyps]]> https://biospectrumindia.com/news/95/15307/novartis-gets-fda-filing-acceptance-of-xolair-to-treat-nasal-polyps.html https://biospectrumindia.com/news/95/15307/novartis-gets-fda-filing-acceptance-of-xolair-to-treat-nasal-polyps.html Wed, 11 Dec 2019 12:25:00 +0530 Novartis announced that the US Food and Drug Administration (FDA) has accepted the company's supplemental Biologics License Application (sBLA) for Xolair® (omalizumab) for the treatment of nasal polyps in adult patients 18 years of age and older with inadequate response to intranasal corticosteroids. If approved, Xolair would become the first antibody to help reduce the size of nasal polyps and help improve symptoms through targeting and blocking immunoglobulin E (IgE). The FDA is expected to make a decision on approval for this indication by Q3 2020. "With millions of Americans living with this serious respiratory condition, there is a significant unmet need for additional treatment options for patients who do not respond to intranasal corticosteroids," said Victor Bultó, President, Novartis Pharmaceuticals Corporation. "The FDA's acceptance of this sBLA is an important step on our path to continually reimagining medicine and understanding the full potential of Xolair across allergic, respiratory and inflammatory conditions and associated comorbidities." Xolair is an injectable biologic medicine designed to target and block IgE. Xolair is currently approved for the treatment of moderate to severe persistent allergic asthma in people six years of age or older whose asthma symptoms are not controlled by inhaled corticosteroids, and for chronic idiopathic urticaria (CIU) in people 12 years of age and older who continue to have hives that are not controlled by H1 antihistamines. In the US, Novartis Pharmaceuticals Corporation and Genentech work together to develop and co-promote Xolair. In November 2019, Novartis submitted to the European Medicines Agency a Type II variation application for Xolair for the treatment of nasal polyps. A decision is expected in 2020. ]]> <![CDATA[Panacea Biotec launches anti-diabetes drug ViLACT]]> https://biospectrumindia.com/news/95/15303/panacea-biotec-launches-anti-diabetes-drug-vilact.html https://biospectrumindia.com/news/95/15303/panacea-biotec-launches-anti-diabetes-drug-vilact.html Wed, 11 Dec 2019 10:40:00 +0530 Panacea Biotec is pleased to announce launch of brand ViLACT in India. ViLACT is used in the treatment of Uncontrolled Type 2 Diabetes Mellitus patients with HbA1c >6.5%.   VilACT is available in four formulations:  1. ViLACT                     :         Vildagliptin 50 mg Tablet. 2. ViLACT M 500         :         Vildagliptin 50 mg + Metformin HCL 500 mg Tablet. 3. ViLACT  M 850        :         Vildagliptin 50 mg + Metformin HCL 850 mg Tablet. 4. ViLACT M 1000       :         Vildagliptin 50 mg + Metformin HCL 1000 mg Tablet.   The total market size of this molecule and its combination is Rs 969 Crore as per AIOCD MAT October ‘2019 and is growing at the rate of 4%. Vildagliptin product patent (IN 212815) in India has expired on 09th December ‘2019. Vildagliptin is a new oral antidiabetic agent that enhances pancreatic islet cell responsiveness to glucose, is an incretin enhancer, a potent and selective inhibitor of dipeptidyl peptidase-4 (DPP-4), the enzyme responsible for the rapid degradation of the incretin hormones glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic peptide (GIP). This activity increases levels of active incretins and enhances pancreatic islet α- and β-cell responsiveness to glucose, thus improving insulin secretion and reducing inappropriate glucagon production, improving insulin sensitivity, improving postprandial lipid and lipoprotein metabolism, and reducing fasting and prandial glucose and HbA1c.   Speaking on the occasion Dr. Rajesh Jain, Managing Director said: “Diacar Strategic Business Unit (SBU) has launched ViLACT brand family.  This will open up a new segment for accelerated growth of the SBU.  I am pleased to share that during pre-launch activity that started in the month of October ‘2019, an innovative campaign was launched to protect our environment wherein 10,000 Doctors from all over India participated by pledging I “ViL ACT” to save the environment by planting over 10,000 plants, saying NO to plastic using Khadi bags, in the process giving boost to MSME sector as part of promoting use of Khadi.   In New Year 2020, our aim is to reach 100,000 Doctors and plant over 100,000 saplings and we have created a website https://vilact.panaceabiotec.com on this occasion.   Susheel Umesh, Chief Executive, Domestic Formulation said the VilACT brand will be an affordable, high quality medicine in the armamentarium of a physician treating patients with Diabetes. The patients have always been and will continue to be the center of our business. The Physician needs a lot of options to bring down the burden of Diabetes and we with the VilACT range will continue to support the patient and physician in this journey.”  ]]> <![CDATA[Sanofi reveals new plan to drive innovation and growth]]> https://biospectrumindia.com/news/95/15298/sanofi-reveals-new-plan-to-drive-innovation-and-growth.html https://biospectrumindia.com/news/95/15298/sanofi-reveals-new-plan-to-drive-innovation-and-growth.html Tue, 10 Dec 2019 11:50:00 +0530 At Sanofi’s Capital Markets Day tomorrow with the financial community, the company will provide details of a new strategic framework with four key priorities to drive innovation and growth. Sanofi will also discuss the alignment of the organization to support this new strategy. Sanofi Chief Executive Officer Paul Hudson and Executive Committee members will provide a detailed overview of the company’s strategy based on four main priorities – focusing the portfolio, leading with science, accelerating efficiency, and reinventing how the company works. “Our new strategy positions Sanofi to achieve breakthroughs with our most promising medicines, addressing significant patient needs. We will anchor our efforts in leading-edge science with clearer priorities and a focus on delivering results,” said Hudson. “Sanofi gained leadership and changed the practice of medicine in diabetes and cardiovascular diseases. We are now preparing for our next cycle, with a new round of innovative solutions for patients. I’m confident we will achieve long-term growth and value for shareholders while turning innovation into transformative medicines for patients.” Focus on growth Dupixent® (dupilumab)2 – Sanofi expects to deliver strong growth for Dupixent with the ambition of achieving more than €10 billion in peak sales driven by its unique mechanism of action targeting the type 2 inflammation pathway. Vaccines – Vaccines are expected to deliver a mid-to-high single-digit net sales CAGR from 2018 to 2025, through differentiated products, market expansion and new launches. Pipeline – The company has identified and prioritized six potentially transformative therapies. Additional core drivers include treatments for oncology, hematology, rare diseases, neurology, and Sanofi’s strong presence in China. Lead with innovation Sanofi has six potentially practice changing therapies in areas of high unmet patient need. These investigational therapies are listed as follows in order of planned submission timing: Fitusiran is an RNAi therapeutic in development for the treatment of hemophilia A and B with or without inhibitors with the potential to provide once-monthly dosing convenience.  BIVV0013 is a factor VIII therapy designed to extend protection from bleeds with prophylaxis dosing of once weekly for people with hemophilia A that seek to enjoy a normalized lifestyle. Venglustat is an oral therapy in development for several rare diseases in the category of lysosomal storage disorders (Gaucher type 3, Fabry, Tay-Sachs disease, etc.), and also showing promise for more common disorders including autosomal dominant polycystic kidney disease and some sub-types of Parkinson’s disease. SERD (‘859) is a selective estrogen receptor degrader which aims to be the new standard of care in hormone-receptor-positive breast cancer. Nirsevimab4 is a potentially cost-effective prevention against respiratory syncytial virus, with initial focus on protecting infants. BTKi (‘168)5 is an oral medicine for multiple sclerosis with potential to be the first disease-modifying therapy to address inflammation and disability drivers in the brain.  The company also announced plans to acquire Synthorx, Inc. which will bolster its immuno-oncology (IO) pipeline with both a proprietary IO platform synergistic with Sanofi’s existing therapeutics platforms, and a lead IO candidate (THOR-707) being explored across multiple solid tumor types both alone and in combination with immune checkpoint inhibitors and other future IO combinations. Sanofi plans to hold a R&D Day in 2020 to provide a detailed review of its R&D portfolio of candidate medicines, strategy, and specifically productivity. Accelerate efficiency Sanofi expects to expand its business operating income (BOI) margin1  to 30% by 2022, with an ambition for its BOI margin to exceed 32% by 2025. The company is also announcing efficiency initiatives that are expected to generate €2 billion savings by 2022. These savings will fund investment in its key growth drivers and accelerate priority pipeline projects as well as support the expansion of the BOI margin. The efficiency savings are expected to result primarily from limiting spend on de-prioritized businesses, from smart spending (procurement) initiatives and from operational excellence in manufacturing and organizational productivity. Regarding de-prioritized businesses, Sanofi is announcing a discontinuation of research in diabetes and cardiovascular (DCV) and will not pursue plans to launch efpeglenatide6. The company will also optimize the commercial model for DCV and rheumatoid arthritis, including right-sizing the resources deployed behind Praluent® (alirocumab)2 and Kevzara® (sarilumab)2. Reinventing how we work Sanofi will be structured with three core global business units to support the company’s strategy7 – Speciality Care (immunology, rare diseases, rare blood disorders, neurology and oncology), Vaccines, and General Medicines (diabetes, cardiovascular, and established products). Consumer Healthcare will be a standalone business unit with integrated R&D and manufacturing functions. Hudson explained, “Our objective for the Consumer Healthcare business is to unlock value and entrepreneurial energy by growing faster than the market over mid-term. We believe the new standalone structure, coupled with plans to accelerate the over-the-counter switches for Cialis® and Tamiflu®, will position the business well to accomplish this ambition.” Focused capital allocation Sanofi expects to increase its annual Free Cash Flow by approximately 50% by 2022 compared with an adjusted base of €4.1bn in 2018.8 Sanofi continues its focused and disciplined capital allocation policy. It expects to deploy cash generated from its three core GBUs as well as the standalone CHC business with the following order of preference: Organic investment Business Development and M&A activities, focusing on bolt-on, value-enhancing opportunities to drive scientific and commercial leadership in core therapeutic areas Growing the annual dividend Anti-dilutive share buybacks Additionally, Sanofi has the potential to raise capital through asset disposals, including streamlining “tail” brands in its Established Products business, and by monetizing its stake after the expiry of the lock-up under the amended and restated investor agreement with Regeneron. ]]> <![CDATA[FDA approves Amgen's biosimilar AVSOLA]]> https://biospectrumindia.com/news/95/15284/fda-approves-amgens-biosimilar-avsola.html https://biospectrumindia.com/news/95/15284/fda-approves-amgens-biosimilar-avsola.html Mon, 09 Dec 2019 10:15:00 +0530 Amgen has announced that the U.S. Food and Drug Administration (FDA) has approved AVSOLA™ (infliximab-axxq) for all approved indications of the reference product, Remicade® (infliximab): for the treatment of moderate-to-severe rheumatoid arthritis (RA), moderate-to-severe Crohn's Disease (CD) in the adult and pediatric population, moderate-to-severe ulcerative colitis (UC) in the adult and pediatric population, chronic severe plaque psoriasis (PsO), psoriatic arthritis (PsA) and ankylosing spondylitis (AS). "The approval of AVSOLA represents an important milestone across our biosimilar and inflammation portfolios," said Murdo Gordon, executive vice president of Global Commercial Operations at Amgen. "Following July's exciting launches of our two biosimilars in oncology, AVSOLA highlights Amgen's long-term commitment to providing more affordable biological treatment options to patients across critical disease states, including chronic inflammatory conditions." AVSOLA, an anti-tumor necrosis factor alpha (anti-TNF) monoclonal antibody, was proven to be highly similar to Remicade with no clinically meaningful differences based on a totality of evidence which included comparative analytical, nonclinical and clinical data. The data package was composed of, in part, results from a pharmacokinetic (PK) similarity study conducted in healthy subjects, and a comparative clinical study conducted in patients with moderate to severe RA. Amgen has a total of 10 biosimilars in its portfolio, four of which have been approved in the U.S., and 3 that are approved in the European Union (EU). ]]> <![CDATA[Mankind Pharma develops dydrogesterone for infertility & pregnancy related complications]]> https://biospectrumindia.com/news/95/15277/mankind-pharma-develops-dydrogesterone-for-infertility-pregnancy-related-complications.html https://biospectrumindia.com/news/95/15277/mankind-pharma-develops-dydrogesterone-for-infertility-pregnancy-related-complications.html Fri, 06 Dec 2019 12:55:00 +0530 Mankind Pharma has launched a Dydrogesterone-containing drug, for treatment of pregnancy-related complications. The company is now the first Indian and second global company to develop the drug and make it available at an affordable price. Progesterone is a natural hormone involved in the menstrual cycle, implantation, and in successful maintenance of pregnancy. Any deficiency of progesterone during different stages of the reproductive process can cause infertility, menstrual disorders and miscarriage. Dydrogesterone has a similar molecular structure to natural progesterone but it has enhanced bioavailability and fewer side-effects. R.C. Juneja, Chairman and Founder, Mankind Group said, “The launch of this drug is an important milestone for Mankind Pharma. We are the first Indian pharmaceutical company to develop this drug & second company in the world. We have been successful in developing the drug as an ideal alternative.  It was only possible after the endless efforts of our scientists that we could achieve the unachievable. Our focus is to earn the trust of our customers by marketing it at an affordable price while ensuring high quality.” It took nine years for a team of 400 scientists at Mankind Research Centre to develop this drug, which is the only retroprogesterone available commercially. The manufacturing process of Dydrogesterone is very complex as it involves the conversion of natural progesterone.   ]]> <![CDATA[HEC Pharm, Biocon, Sun Pharma get FDA approval for MS drug]]> https://biospectrumindia.com/news/95/15269/hec-pharm-biocon-sun-pharma-get-fda-approval-for-ms-drug.html https://biospectrumindia.com/news/95/15269/hec-pharm-biocon-sun-pharma-get-fda-approval-for-ms-drug.html Fri, 06 Dec 2019 10:30:00 +0530 The U.S. Food and Drug Administration has approved three applications for first generics of Gilenya (fingolimod) capsules for the treatment of relapsing forms of multiple sclerosis (MS) in adult patients. "Approving safe and effective generics so patients have more treatment options continues to be a priority for the FDA," said Janet Woodcock, M.D., director of the FDA's Center for Drug Evaluation and Research. "Having access to affordable treatments is important for patients with conditions that require ongoing care. The FDA has a longstanding commitment to increasing patient access to lower-cost, high-quality generic medicines." MS is a chronic, inflammatory, autoimmune disease of the central nervous system that disrupts communication between the brain and other parts of the body. It is among the most common causes of neurological disability in young adults and occurs more frequently in women than men. For most people with MS, episodes of worsening function and appearance of new symptoms, called relapses or flare-ups, are initially followed by recovery periods (remissions). Over time, recovery may be incomplete, leading to progressive decline in function and increased disability. Gilenya is a widely used orally administered treatment option. Fingolimod must be dispensed with a Medication Guide that contains important information about its uses and risks. Serious risks include slowing of the heart rate, especially after the first dose. Fingolimod may increase the risk of serious infections. Patients should be monitored for infection during treatment and for two months after discontinuation of treatment. A rare brain infection that usually leads to death or severe disability, called progressive multifocal leukoencephalopathy (PML) has been reported in patients being treated with the drug. PML cases usually occur in patients with weakened immune systems. The FDA granted approvals of generic fingolimod applications to HEC Pharm Co. Limited, Biocon Limited and Sun Pharmaceutical Industries Limited. ]]> <![CDATA[Mankind develops drug for pregnancy related complications]]> https://biospectrumindia.com/news/95/15268/mankind-develops-drug-for-pregnancy-related-complications.html https://biospectrumindia.com/news/95/15268/mankind-develops-drug-for-pregnancy-related-complications.html Fri, 06 Dec 2019 06:05:00 +0530 Mankind Pharma, a Rs 5,600 crore pharmaceutical company, has launched a Dydrogesterone-containing drug, for treatment of pregnancy-related complications. Mankind Pharma becomes the first Indian and second global company to develop the drug and make it available at an affordable price.  Progesterone is a natural hormone involved in the menstrual cycle, implantation, and in successful maintenance of pregnancy. Any deficiency of progesterone during different stages of the reproductive process can cause infertility, menstrual disorders and miscarriage. Dydrogesterone has a similar molecular structure to natural progesterone but it has enhanced bioavailability and fewer side-effects.  It took nine years for a team of 400 scientists at Mankind Research Centre to develop this drug, which is the only retroprogesterone available commercially. The manufacturing process of Dydrogesterone is very complex as it involves the conversion of natural progesterone.  R.C. Juneja, Chairman and Founder, Mankind Group said, “The launch of this drug is an important milestone for Mankind Pharma. We are the first Indian pharmaceutical company to develop this drug & second company in the world. We have been successful in developing the drug as an ideal alternative.  It was only possible after the endless efforts of our scientists that we could achieve the unachievable. Our focus is to earn the trust of our customers by marketing it at an affordable price while ensuring high quality.”    ]]> <![CDATA[Biocon Biologics to unlock universal access to insulins globally]]> https://biospectrumindia.com/news/95/15267/biocon-biologics-to-unlock-universal-access-to-insulins-globally.html https://biospectrumindia.com/news/95/15267/biocon-biologics-to-unlock-universal-access-to-insulins-globally.html Thu, 05 Dec 2019 14:15:00 +0530 Biocon Biologics, a fully integrated 'pure play' global biosimilars organisation, is taking forward its mission of unlocking affordable access to quality insulins for people with diabetes across the world. As a credible, global insulins player, it is committed to address the growing healthcare challenges associated with diabetes worldwide and is driven by its mission to enable affordable access. Even as we near the 100th anniversary of the discovery of insulin, lack of equitable access to affordable insulin remains a key impediment to successful treatment for diabetes, leading to co-morbid complications and premature deaths. Diabetes currently affects over 463 million people worldwide and is projected to reach 578 million by 2030.  Biocon Biologics has taken the lead to enable affordable access to insulins for patients across the world to ensure that people with diabetes who need insulins must get them. Pursuing an innovation strategy that is rooted in affordability, Biocon has cumulatively supplied over 2 billion doses of biosimilar insulins to patients globally over the last 15 years. In September 2019, the Company made an announcement to enable universal access to recombinant human Insulin (rh-Insulin), by offering it at less than 10 US cents / day for Governments in LMICs. Kiran Mazumdar Shaw, Chairperson & MD, Biocon, said: "At Biocon, we are guided by the conviction that a lifesaving product like insulin cannot be priced out of the reach of those that need it on an everyday basis. We are committed to reducing the price of our insulin even further through partnerships with agencies like WHO, UNAIDS & others in order to break the barrier to access in certain geographies which are too poor to deal with the challenge of Diabetes on their own."   Taking ahead its commitment to provide Universal Access to high quality insulins, Biocon Biologics made its debut at the International Diabetes Federation (IDF) Congress at Busan, South Korea, held from December 2-6, 2019.    Christiane Hamacher, CEO, Biocon Biologics, said: "In the run-up to the 100th anniversary of insulin, Biocon Biologics has embarked on a mission to unlock universal access to high quality insulin, guided by the conviction that a lifesaving product like this needs to be accessible to patients globally, both in emerging and developed countries. Our participation at the IDF Congress 2019 is aimed at addressing current issues around insulin access, especially opportunities and value offered by biosimilars, how to achieve equitable care and sustaining India's role as pharmacy to the world. In line with our aspiration to reach 'one in five' insulin-dependent people with diabetes globally, we want to work closely with key stakeholders worldwide to find ways to ensure that insulin reaches those who need them the most." ]]> <![CDATA[Strides gets USFDA tentative nod for pain relieving drug]]> https://biospectrumindia.com/news/95/15266/strides-gets-usfda-tentative-nod-for-pain-relieving-drug.html https://biospectrumindia.com/news/95/15266/strides-gets-usfda-tentative-nod-for-pain-relieving-drug.html Thu, 05 Dec 2019 11:10:00 +0530 Strides Pharma Science Limited (Strides) has announced that its step‐down wholly owned subsidiary, Strides Pharma Global Pte. Limited, Singapore, has received tentative approval for Diclofenac Potassium Softgel Capsules, 25 mg from the United States Food & Drug Administration (USFDA). The product is a generic version of Zipsor Capsules, 25 mg, of Assertio Therapeutics, Inc.  Strides specializes in softgel domain and is a global leader in the Rx space. Strides now has a   large portfolio of softgel products which comprises of 11 approved products for the US markets along with a strong product pipeline cutting across several therapeutic segments. Diclofenac Potassium Softgel Capsules is part of Strides niche and small volume product portfolio with limited competition in the US market. According to IQVIA MAT data, the US market for Diclofenac Potassium Softgel Capsules, 25 mg is approximately US$ 30 Mn. Strides can launch the product earliest by September 2022 based on terms of settlement. On receiving full approval, the product will be manufactured at the company’s Oral dosage facility at Bangalore and marketed by Strides Pharma Inc in the US Market.   The company has 102 cumulative ANDA filings with USFDA of which 67 ANDAs have been approved and 35 are pending approval.  About Diclofenac Potassium Softgel Capsules Diclofenac Potassium Softgel Capsule is a nonsteroidal anti‐inflammatory drug used to relieve pain and swelling from various mild to moderate painful conditions. It is used to treat muscle aches, backaches, dental pain, menstrual cramps, and sports injuries.   ]]> <![CDATA[Eris buys Zomelis from Novartis AG for $13M]]> https://biospectrumindia.com/news/95/15257/eris-buys-zomelis-from-novartis-ag-for-13m.html https://biospectrumindia.com/news/95/15257/eris-buys-zomelis-from-novartis-ag-for-13m.html Thu, 05 Dec 2019 06:05:00 +0530 Gujarat based Eris Lifesciences has announced the acquisition of the trademark Zomelis (for Vildagliptin based formulations) and its associated trademarks from Novartis AG, Switzerland for a consideration of $13 million. Zomelis is used in the treatment of type 2 diabetes and comes under a new class of anti-diabetic drugs known as DPP 4 inhibitors. The Company will start selling the product from December 10 in the Indian market. Eris is among the top 10 players in the anti-diabetes drugs segment in the Indian Pharmaceutical Market (IPM). Amit Bakshi, Chairman and Managing Director, Eris Lifesciences, said, “The acquisition of Zomelis will help us strengthen our position in the diabetes care market in India. Zomelis is a strong brand amongst the super speciality prescriptions and has been promoted for close to 10 years. Our inorganic growth strategy continues as we explore good opportunities to strengthen our product offering for patients.” This is the first innovator pharmaceutical product trademark acquisition by Eris. The company did four acquisitions earlier. In December 2017, Eris acquired the branded business portfolio of Strides Shasun in a deal worth Rs 500 crore gaining a foothold, inter-alia, in the CNS drug segment. Three earlier acquisitions of UTH, Kinedex and Amay Pharma (trademarks) provided entry for Eris in the nutraceuticals, women health, IVF, etc.   ]]> <![CDATA[Piramal Pharma collaborates with BerGenBio]]> https://biospectrumindia.com/news/95/15256/piramal-pharma-collaborates-with-bergenbio.html https://biospectrumindia.com/news/95/15256/piramal-pharma-collaborates-with-bergenbio.html Thu, 05 Dec 2019 05:05:00 +0530 The Pharma Solutions business of Piramal Enterprises Limited, a leading development and contract manufacturing company (CDMO), announced that the company is going to Associate with BerGenBio ASA to develop bemcentinib for the treatment of elderly patients with recurrent acute myeloid leukemia (AML). Bemcentinib has recently been designated as a fast track  drug by the US Food and Drug Administration (FDA), as for the patients with recurrent AML, there are currently no marketed drugs specifically approved for use in Canada. Peter DeYoung ,  CEO of Piramal Pharma Solutions , said, "The fact that BerGenBio decided to partner with us validates our integrated business model. The breadth and depth of our assets and the expertise we have gained as a leading CDMO allow us to tailor our services to their needs and deliver solutions that bring benefits to patients. " Richard Godfrey , BerGenBio's President and Chief Executive Officer , said, "We urgently need outsourcing of development and manufacturing services and we have been rigorous in our pre-audit with potential partners. The capabilities of Piramal Pharma Solutions, in particular the Xcelerate Integrated Solutions Platform, represent an ideal solution for BerGenBio. " In order to accelerate the time required to implement the expedited procedure, PPS will develop the drug based on its Xcelerate Integrated Solutions ™ platform that provides speed, flexibility and versatility in the drug development process. The Xcelerate platform, which responds to the sector's growing need for close relationships with partners, has been successfully applied to more than 80 programs. Xcelerate Integrated Solutions ™ leverages PPS's broad network of drug discovery and development capabilities, which can be found at its sites in North America, Europe and India. Customers benefit from streamlined and fully integrated services, all of which are managed by a single point of contact, speeding up the exchange of information and deadlines. The bemcentinib development program encompasses a fully integrated program of PPS resources that includes intermediate products from India, development of pilot processes and validation of active ingredients in North America, as well as formulation development in Europe. As part of the partnership agreement, PPS should also ensure the commercial manufacture of the final pharmaceutical product. ]]> <![CDATA[Dr. Reddy's announces the launch of Bortezomib ]]> https://biospectrumindia.com/news/95/15262/dr-reddys-announces-the-launch-of-bortezomib-.html https://biospectrumindia.com/news/95/15262/dr-reddys-announces-the-launch-of-bortezomib-.html Wed, 04 Dec 2019 16:05:00 +0530 Dr. Reddy’s Laboratories has announced the launch of Bortezomib for Injection 3.5 mg/vial, approved by USFDA via a 505(b)(2) new drug application (NDA) pathway for intravenous use only. Marc Kikuchi, Chief Executive Officer, North America Generics, Dr. Reddy’s Laboratories said, “We’re pleased to bring this product to market for the customers and patients who will benefit from this cost efficient alternative in the market place. This is a great addition to our injectable offering in the U.S. market as we continue to augment our portfolio of products in the Hospital segment.” Dr. Reddy’s Bortezomib for Injection 3.5 mg/vial is for intravenous use only and is indicated for the treatment of adult patients with multiple myeloma and for the treatment of adult patients with mantle cell lymphoma who have received at least one prior therapy.     ]]> <![CDATA[Bharat Biotech rolls out ROTAVAC 5D vaccine]]> https://biospectrumindia.com/news/95/15255/bharat-biotech-rolls-out-rotavac-5d-vaccine.html https://biospectrumindia.com/news/95/15255/bharat-biotech-rolls-out-rotavac-5d-vaccine.html Tue, 03 Dec 2019 18:15:00 +0530 Bharat Biotech announced the commercial roll-out of ROTAVAC 5D-Lowest dose volume rotavirus vaccine in the world. M Venkaiah Naidu, Vice President of India launched the vaccine in New Delhi. The first generation, rotavirus vaccine, ROTAVAC was developed under a Public-Private Partnership with the Department of Biotechnology and other international partners. Congratulating Bharat Biotech about its milestone achievement in delivering 100 Million doses of ROTAVAC vaccine and launching the new generation ROTAVAC 5D, in his address the vice-president urged the media and medical professionals to create awareness about various health problems. He said, “There is a need for vaccination at the right time, while the government is doing its best, it is a greater social responsibility which every medical professional should take upon themselves, remove apprehension about vaccination, for prevention of disease and to better the health of the nation and its people.” Developed by Bharat Biotech, oral rotavirus vaccine ROTAVAC 5D is safe and effective in the prevention of rotavirus diarrhea. ROTAVAC 5D can be stored at 2-8 degree, administered in 5 drops. ROTAVAC 5D is available in single-dose, multi-dose vials and pre-filled syringes. The company received commercial licensure and the vaccine is available for sale. Speaking on the launch, Dr Krishna Ella, Chairman & MD, Bharat Biotech said, “We are proud to announce the milestone of 100 million doses of ROTAVAC supplies, the fastest among rotavirus vaccines in the world. Building on this success, we are pleased to announce the introduction of ROTAVAC 5D the lowest dose volume rotavirus vaccine in the world.” Dr Ella added, “We have designed and developed a vaccine that is cost-effective due to its efficacy and low cold chain footprint. ROTAVAC 5D presented in multi dose vials, results in savings of app. $0.30/dose in supply chain and delivery costs.” ROTAVAC 5D has been evaluated in clinical trials in India and other countries. This vaccine is safe, effective and affordable, besides being cross-protective against a variety of rotavirus strains. Its efficacy compares favorably with the efficacy of the currently licensed rotavirus vaccines in low-resource countries. The study results showed clear evidence of protection across different rotavirus strains and continued efficacy in the second year of life. Currently, over 25 countries have granted patents for ROTAVAC 5D. Dr Ella also revealed, “Bharat Biotech has invested approx. 20 million to develop new manufacturing facilities and supporting infrastructure in its Genome Valley plant in Hyderabad, with an installed manufacturing capacity of app 200 million doses/year. The project was supported in part by the Bill & Melinda Gates Foundation.” Dr Seth Berkley, CEO of Gavi, the vaccine Alliance said, “The introduction of this rotavirus vaccine has helped protect millions against the leading cause of deadly diarrhea in children worldwide and has been critical in ensuring better supply availability as well as diversity of product profiles. Bharat Biotech has been a key partner for Gavi, and I commend the company and its employees for reaching this milestone so quickly.” Steve Davis, President & CEO of the PATH said, “Rotavirus continues to cause severe diarrheal disease and deaths, mostly among the most vulnerable children in the world. We are proud of PATH’s partnership with Bharat Biotech and other international researchers in the development of ROTAVAC and ROTAVAC 5D, and we are pleased to see them helping to improve the supply of affordable rotavirus vaccines as they are rolled out in public health programs in India and around the world.” Globally rotavirus disease burden is estimated at approx. 200,000 deaths and approx. 2.0 million hospitalizations annually, mostly in low income countries. Prevention of rotavirus infections would lead to a significant reduction in infant mortality rates and reduce economic impact of hospitalizations to national governments across the globe. ]]> <![CDATA[Lupin Foundation wins Award at India Pharma Awards 2019 ]]> https://biospectrumindia.com/news/95/15252/lupin-foundation-wins-award-at-india-pharma-awards-2019-.html https://biospectrumindia.com/news/95/15252/lupin-foundation-wins-award-at-india-pharma-awards-2019-.html Tue, 03 Dec 2019 16:20:00 +0530 Lupin has announced that its corporate social responsibility (CSR) arm, the Lupin Foundation won the prestigious award for ‘Excellence in Corporate Social Responsibility’ at the India Pharma Awards 2019 held in Greater Noida. Lupin was conferred this award in the category for companies with turnover more than INR 500 Cr. The jury panel, represented by various segments of the Indian Pharmaceutical Industry chose the Lupin Foundation for its unwavering commitment and efforts to uplift the rural population in remote areas across India through initiatives focused on socio-economic improvement and women and children welfare.  Commenting on the occasion, Ram Gupta, Executive Director, Lupin Foundation said, “It is an honour to be bestowed with this prestigious award. As a frontrunner in the CSR space, we strive to give back to society and make a positive impact. This award acknowledges the organisation’s commitment towards society. Such recognitions also encourage us to deepen our CSR footprint — continually building on the vision provided by our beloved founder, Dr. Desh Bandhu Gupta.”   Currently in its seventh year, the India Pharma Awards celebrates the advancements and achievements of the Indian Pharmaceutical Industry.  The event was a part of the India Pharma Week 2019 and recognises companies and personnel from this industry.   ]]> <![CDATA[Alembic’s JV Aleor gets USFDA nod for Diclofenac Sodium Solution]]> https://biospectrumindia.com/news/95/15249/alembics-jv-aleor-gets-usfda-nod-for-diclofenac-sodium-solution.html https://biospectrumindia.com/news/95/15249/alembics-jv-aleor-gets-usfda-nod-for-diclofenac-sodium-solution.html Tue, 03 Dec 2019 11:40:00 +0530 Alembic Pharmaceuticals Limited (Alembic), a vertically integrated research and development pharmaceutical company, headquartered in India, manufactures and markets generic pharmaceutical products all over the world. Alembic has announced that its joint venture Aleor Dermaceuticals Limited (Aleor) has received tentative approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Diclofenac Sodium Topical Solution USP, 2% w/w. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Pennsaid Topical Solution, 2% w/w, of HZNP Medicines LLC (HZNP). Diclofenac Sodium Topical Solution USP, 2% w/w is indicated for the treatment of the pain of osteoarthritis of the knee(s). Diclofenac Sodium Topical Solution USP, 2% w/w, has an estimated market size of US$ 974 million for twelve months ending December 2018 according to IQVIA. Alembic has a cumulative total of 109 ANDA approvals (96 final approvals and 13 tentative approvals) from USFDA. Alembic Pharmaceuticals Limited, a vertically integrated research and development pharmaceutical company, Headquartered in India, manufactures and markets generic pharmaceutical products all over the world. ]]> <![CDATA[Biocon, Mylan launch Ogivri in the US]]> https://biospectrumindia.com/news/95/15248/biocon-mylan-launch-ogivri-in-the-us.html https://biospectrumindia.com/news/95/15248/biocon-mylan-launch-ogivri-in-the-us.html Tue, 03 Dec 2019 10:15:00 +0530 Biocon Ltd. and Mylan N.V. have announced the U.S. launch of Ogivri™ (trastuzumab-dkst), a biosimilar to Herceptin® (trastuzumab). Ogivri is available in a 420mg multi-dose vial and a 150mg single-dose vial in order to provide patient dosing and treatment flexibility. Ogivri was the first biosimilar trastuzumab approved by the U.S. Food and Drug Administration (FDA) and unanimously recommended by the FDA Oncologic Drugs Advisory Committee (ODAC). Ogivri is approved for all indications of Herceptin including for the treatment of HER2-overexpressing breast cancer and metastatic stomach cancer (gastric or gastroesophageal junction adenocarcinoma). Trastuzumab and biosimilar trastuzumab products contain a Boxed Warning for cardiomyopathy, infusion reactions, pulmonary toxicity and embryo-fetal toxicity.  Two supplemental Biologics License Applications were recently approved by the FDA, expanding the manufacturing capability for Ogivri, as well as Mylan and Biocon’s first U.S. biosimilar, Fulphila®, a biosimilar to Neulasta®. Mylan and Biocon Biologics have sufficient manufacturing capacity to fulfil demand in the U.S. and global markets for both products. Dr Christiane Hamacher, CEO, Biocon Biologics, said: “The U.S. launch of Ogivri, the biosimilar trastuzumab co-developed by Biocon Biologics and Mylan, marks a significant milestone in our biosimilars journey. It is an important endorsement of our science, development and manufacturing capabilities in the area of monoclonal antibodies. The introduction of both 420mg multi-use vials and 150mg single-use vials of a high quality biosimilar trastuzumab with robust long-term efficacy and safety data will offer greater choice and value to patients, prescribers and payors in the U.S. As a global frontrunner in biosimilars, Biocon Biologics is committed to fulfil unmet patient needs by providing greater affordability for enhanced patient access. We aspire to serve 5 million patients through our biosimilars portfolio and cross a revenue milestone of US$ 1bn by FY22.” Mylan President Rajiv Malik commented: “As one of the largest suppliers of oncology medicines in the U.S., we are proud to offer Ogivri, biosimilar trastuzumab, in both the 420mg and 150mg strengths and help increase more affordable access to this important treatment option for breast and gastric cancer patients. With regulatory approval for our biosimilar trastuzumab in more than 80 countries worldwide, we are bringing vast global biosimilars experience to the U.S. and look forward to continuing our work with all stakeholders in the healthcare system to reduce costs, improve access and advance care. With Ogivri, Fulphila and our generic oncology portfolio, Mylan is uniquely positioned to provide a broad range of treatment options for oncology patients.”  FDA approval of Ogivri was based on robust data demonstrating that Ogivri is highly similar to Herceptin and no clinically meaningful differences exist between the biosimilar product and Herceptin in terms of safety, purity and potency. Long-term results of the landmark HERITAGE study including overall survival data at 36 months were presented at this year’s American Society of Clinical Oncology (ASCO) Annual Meeting. Dr. Hope S. Rugo, professor of medicine at the University of California, San Francisco, and lead author of the HERITAGE study commented: “Trastuzumab-dkst (Ogivri) has many firsts to its credit. It was one of the first biosimilar oncology products to get a unanimous approval vote at an ODAC meeting, and it was the first biosimilar study to be published in the Journal of the American Medical Association. In this context, the HERITAGE study had a unique trial design that not only evaluated objective response rate at week 24 as its primary endpoint but also assessed key endpoints including progression-free survival rate and overall survival at 36 months. The concordant efficacy data across all three endpoints conclusively demonstrated that Ogivri was similar to Herceptin, and patients without progression now continue on Ogivri as maintenance therapy. We are pleased that patients with HER2-positive cancers now have an additional treatment option backed by robust safety and efficacy data, including long-term 36-month data. The worldwide introduction of this agent has already improved access to trastuzumab.” ]]> <![CDATA[CAS launches Formulus in India]]> https://biospectrumindia.com/news/95/15244/cas-launches-formulus-in-india.html https://biospectrumindia.com/news/95/15244/cas-launches-formulus-in-india.html Tue, 03 Dec 2019 06:05:00 +0530 CAS, a division of the American Chemical Society that specializes in scientific information solutions, has now launched Formulus® in India, the collection of formulations sourced from journals, patents and product inserts. Formulus is the new one-stop shop for research scientists looking to search through millions of formulations quickly and efficiently. This product can be a potential gamechanger for India’s pharmaceutical and agrochemical sector because it streamlines and simplifies the time-consuming process of formulating new products and can help new innovations get to market faster. CAS will be holding workshops this week in Mumbai, Hyderabad and Bangalore to demonstrate its capabilities for formulators and researchers. Formulation is a critical component of drug or product development. However, current formulation resources and solutions are lacking, data sources are disparate and existing libraries are small. This causes 60% of companies to experience a project delay or failure due to formulation challenges. In response to this situation, CAS has invested millions of dollars over the past 3 years and conducted over 500 research sessions with formulation scientists in order to develop this tool. Speaking about the launch, Molly Strausbaugh, Assistant Director, CAS, said, “The new CAS collection of formulations has been curated from information found by hundreds of scientists from numerous sources. This data clearly identifies formulation ingredients and their roles and provides users with critical insights, decreasing development time. By speeding up this process, formulators are able to receive reliable information more quickly, allowing them more time to spend on the real-world challenges they’re trying to solve.” Over 70% of formulators that tested Formulus confirmed that it helped them narrow focus more quickly and 73% of formulators agreed that it helped them get up to speed about a new product. CAS formulations content can also be licensed for in-house projects and applications. Formulus is integrated with CAS substance collection, detailed supplier specifications and regulatory resources and the data is also being made available in leading CAS solutions STNext® and SciFindern. ]]> <![CDATA[SCHOTT inaugurates new production facility in Gujarat]]> https://biospectrumindia.com/news/95/15239/schott-inaugurates-new-production-facility-in-gujarat.html https://biospectrumindia.com/news/95/15239/schott-inaugurates-new-production-facility-in-gujarat.html Mon, 02 Dec 2019 06:05:00 +0530 SCHOTT AG, a global leader in pharmaceutical glass manufacturing, has inaugurated its new glass tank facility in Jambusar, Gujarat following an investment of €21 million last year. The company forecasts a rapid growth trend for high quality glass material in the pharma industry, and has thus committed additional investments of €26 million for yet another tank facility in 2020. Each of the new production facilities with a combined investment of €47 million, will double the capacity of SCHOTT Glass India’s manufacturing plant, allowing the group to produce its highly specialised FIOLAX® tubing material for both domestic and export demands. SCHOTT began the construction of its first new facility last year on the occasion of completing two decades of operations in India. The facility finished construction within a record time of one year, enabling employment of another 100 skilled local workforce. The new set-up brings together SCHOTT’s state-of-the-art technology and Indian ingenuity together to produce pharmaceutical packaging and tubing equipment in line with ‘Industry 4.0’ standards. Talking about SCHOTT Glass India’s future plans, Managing Director, Georg Sparschuh shared, “While domestic market remains our key focus, our India plant also caters to the Asian market, thereby contributing to pharmaceutical industry exports and the Indian government’s vision of becoming a global pharmaceutical hub. SCHOTT also takes cognizance of the Indian Health Ministry’s initiative to provide affordable and accessible healthcare to its citizens. In this regard, we wish to be part of such initiatives by contributing to the pharmaceutical value chains and by providing high-quality glass products for pharma packaging, ensuring highest global safety standards.” SCHOTT’s success story runs parallel to India’s phenomenal performance in the World Bank’s Ease of Doing Business Rankings, where India jumped 14 places this year to be ranked 63rd out of 190 countries. “We are among the benefactors of the efforts made by the Government of India in creating an environment conducive for international businesses to invest and set up manufacturing facilities. We plan to continue investing in India as a part of Make in India, as we believe there is great potential in our Indian facilities becoming the hub for providing pharmaceutical equipment for global pharmaceutical supply chains as well. SCHOTT is also collaborating with Indian universities and training institutes to focus on skilling, preparing trainees to match the demands of future industry 4.0 requirements,” said Dr Patrick Markschläger, Executive Vice President, SCHOTT AG, Business Unit Tubing. Dignitaries from the German Consulate, Mumbai, key partners and industry associations such as the CII also graced the inauguration of the new facility. On the occasion, Marja Einig - Deputy Counsul General, German Consulate, Mumbai commended the efforts and said, “SCHOTT is playing a pivotal role in giving a fillip to our efforts in strengthening the Indo-German partnership. Time and again, SCHOTT has showcased its commitment towards India. With its expanded operations in the country, it is catering to the needs of the Indian health industry and contributing to the Indian government’s initiatives such as Make in India and Pharma Vision 2020.” SCHOTT’s India plant functions as a production hub for SCHOTT pharmaceutical tubing in Asia and produces the branded FIOLAX® pharmaceutical tubing. FIOLAX® glass exists since 1911 and provides an unprecedented quality standard in the industry through SCHOTT’s perfeXion® process since 2017. perfeXion® stands for the transition from statistical quality control to 100% automated inspection of each individual FIOLAX® tube – based on big data. Hence, it is introducing Germany’s Industry 4.0 to its Indian factory in the most effective manner. ]]> <![CDATA[Jubilant Biosys selects CDD Vault for next five years]]> https://biospectrumindia.com/news/95/15228/jubilant-biosys-selects-cdd-vault-for-next-five-years.html https://biospectrumindia.com/news/95/15228/jubilant-biosys-selects-cdd-vault-for-next-five-years.html Fri, 29 Nov 2019 10:50:00 +0530 Jubilant Biosys and Collaborative Drug Discovery (CDD) have recently announced that, following an exhaustive evaluation, Jubilant has chosen CDD Vault as their discovery research informatics platform for the next 5 years. Jubilant will be using CDD Vault as their informatics platform to facilitate and boost transparent distribution of research data and information. CDD Vault manages biological assay data, involved chemical structures, reactions and compound properties in a cohesive environment. “CDD Vault will be used across Jubilant research sites; to keep experimental information centralized, both structured and unstructured, to share with clients.” said Marcel Velterop, President of Drug Discovery Services & CDMO at Jubilant Biosys Limited. “Scientists will be able to explore their chemistry and biology data in real-time, enabling rapid decision-making of discovery programs with CDD Vault”. “Jubilant is a leading collaborator for pharmaceutical and biotechnology companies worldwide and we are delighted to assist them in sharing their high quality preclinical R&D services with the life science industry” said Dr. Mariana Vaschetto, General Manager, CDD Global Business. “CDD Vault has been designed for collaborative research within or between organizations in a secure and easy to use way. We are looking forward to this long term relationship with Jubilant and helping them ensure the success of their customers’ research.” ]]> <![CDATA[Jubilant to expand its drug discovery services biz]]> https://biospectrumindia.com/news/95/15227/jubilant-to-expand-its-drug-discovery-services-biz.html https://biospectrumindia.com/news/95/15227/jubilant-to-expand-its-drug-discovery-services-biz.html Fri, 29 Nov 2019 10:10:00 +0530 Jubilant Biosys, a Bengaluru-based subsidiary of Jubilant Lifesciences Limited, has announced commencement of two expansion projects in Greater Noida and Bengaluru. Due to growing customer demand for its range of functional and integrated drug discovery services, Jubilant Biosys has started design and construction of brand new and state-of-theart chemistry services laboratories on the existing Jubilant Greater Noida site. The chemistry FTE capacity will be doubled and operations are expected to commence from H2 2020. The new site can accommodate up to 500 Chemistry FTE’s. The site will be designed for the highest global compliance standards and deliver superior speed and quality in the entire drug discovery process. In Bengaluru, Jubilant Biosys has obtained a 10-acre plot in the Devanahalli Industrial Park which is adjacent to the International Airport. A completely new drug discovery services site will be constructed in phases for further expansions. In addition, we have formed a new digital business unit comprising of Bio-Informatics, Datacuration for AI/ML, TrialStat EDC software as well as discovery focussed AI/ML capabilities.This business unit will also further expand on the new site and deliver increased benefits to our customers. Marcel Velterop, President – Jubilant Biosys and CDMO, said: “The improving customer confidence earned through exemplary scientific execution and a positive outlook in the global drug discovery industry has resulted in the largest investment program in Jubilant Biosys since its inception. We will soon be able to offer our customers much improved capacity and services as well as ability to deliver an integrated IND package along with superior functional discovery services. A combination of the best talent and state-of-the-art technology and instrumentation will be offered to pursue drug discovery collaborations and help deliver new innovation to patients faster than ever. ” ]]> <![CDATA[Japanese firm receives patent in India for nanosheet technique]]> https://biospectrumindia.com/news/95/15222/japanese-firm-receives-patent-in-india-for-nanosheet-technique.html https://biospectrumindia.com/news/95/15222/japanese-firm-receives-patent-in-india-for-nanosheet-technique.html Thu, 28 Nov 2019 15:00:00 +0530 A novel cell transplantation method to treat corneal endothelial diseases such as bullous keratopathy using a nano-composite gel sheet developed by Japanese scientists was granted Indian patent to GN Corporation (GNC), Japan. This method was earlier granted a Japanese patent, in which one cadaver donor cornea derived cells could be used to save vision of several patients’ eyes using lab grown corneal endothelial precursor cells. GNC has partnered with JBM Inc., & Edogawa Evolutionary Laboratory of Science, Tokyo to set up a nanomaterial development facility to produce this nano-composite gel sheet and are open for collaboration with both academic and industry partners in propagating this technique globally. Patients in developing nations where the corneal donor grafts are inadequate to meet the need for patients with corneal diseases waiting for transplantation, will be benefitted by this technique according to the inventors. ]]> <![CDATA[IMCD opens 3 Pharma Technical Centres in Asia Pacific]]> https://biospectrumindia.com/news/95/15220/imcd-opens-3-pharma-technical-centres-in-asia-pacific.html https://biospectrumindia.com/news/95/15220/imcd-opens-3-pharma-technical-centres-in-asia-pacific.html Thu, 28 Nov 2019 13:25:00 +0530 Netherlands based IMCD N.V., a leading distributor of speciality chemicals and food ingredients, has announces the expansion of its global network of Pharmaceutical Technical Centres with the opening of three new locations in India, Southeast Asia and China. These three new centres are part of IMCD’s continued global expansion of its pharmaceuticals network and are the Company’s most substantial investment to date in bolstering its technical pharmaceuticals infrastructure.  The new technical centres will each be able to provide formulation support to the pharma industry in their respective geographies, offering a complete range of formulatory capabilities in oral solid, semi solid and topical pharmaceutical formulations. These capabilities will not only support customers in formulation development but will also provide training and development opportunities for IMCD’s sales team in Asia Pacific. This network of technical centres will be invaluable in growing both IMCD and its supplier partners’ business pipeline in the years ahead. Paul Mimnagh, IMCD Asia Pacific Pharmaceuticals Business Group Director, comments, “The Asia Pacific region is the engine of global pharma growth with rising GDP, increasing access to medicine, improving regulatory landscape, increasing drive for production efficiency and an increasing focus on innovation; all important factors for driving market growth rates far in excess of what we see in the more mature markets of Europe and the North America. Alongside our recently announced acquisitions, this investment in the supporting infrastructure for our pharma business strengthens our global footprint and our capabilities to offer a world-class, value-based offering, locally delivered to our clients in Asia.’’ While each centre will offer a regional support and training function in their respective markets, each will additionally focus on specific areas of formulation technology as part of IMCD’s efforts to cross-fertilise expertise in its growing global network. The Mumbai location will have a focus on topical pharmaceutical applications; SEA will specialise in nutraceuticals, controlled release and coatings expertise; while China will focus on being a Centre of Excellence for reverse engineering and for supporting our generic customers.   ]]> <![CDATA[USFDA approves Biocon’s sBLA for Pegfilgrastim Bengaluru facility]]> https://biospectrumindia.com/news/95/15213/usfda-approves-biocons-sbla-for-pegfilgrastim-bengaluru-facility.html https://biospectrumindia.com/news/95/15213/usfda-approves-biocons-sbla-for-pegfilgrastim-bengaluru-facility.html Wed, 27 Nov 2019 12:45:00 +0530 Biocon Ltd has announced that Biocon and Mylan's supplemental Biologics License Application (sBLA) for Pegfilgrastim Drug Substance to be manufactured at Biocon’s new Biologics manufacturing facility has been approved by the U.S. Food and Drug Administration (FDA). This additional approval of its new manufacturing facility for Pegfilgrastim in Bengaluru will enable Biocon Biologics, a subsidiary of Biocon Ltd, and Mylan to scale up capacity multi-fold and address the growing market opportunities in the U.S. and other global markets. The U.S. FDA had conducted a Pre-Approval Inspection of this new Drug Substance manufacturing facility from Sep 10 to Sep 19, 2019.  Biocon Biologics is uniquely positioned as a fully integrated ‘pure play’ biosimilars organization in the world. It has been investing in expanding its manufacturing capacity in line with its expectations of higher biosimilars penetration in developed and emerging markets. Dr. Christiane Hamacher, CEO, Biocon Biologics, said: “We are extremely pleased with the U.S. FDA approval of our sBLA for Pegfilgrastim manufactured at our new Biologics Drug Substance facility. This is a significant milepost in our journey of serving 5 million patients by FY22 and crossing a revenue milestone of USD 1 billion. Biocon Biologics has been making continued investments in building global-scale, cost-competitive, complex manufacturing capabilities to address global market opportunities. This approval will help us better meet global patient needs for Fulphila®, a high quality biosimilar Pegfilgrastim co-developed with Mylan and manufactured by Biocon Biologics. “Continued penetration of biosimilars will enable higher cost savings for the U.S. healthcare system leading to expansion of patient access to high quality affordable biologics. We are committed to use our science, scale and expertise to shift the access paradigm for patients in need of biosimilars like Pegfilgrastim across the globe,” she added. Biocon Biologics, through its partner Mylan, has commercialized three of its co-developed biosimilars in developed markets like U.S., Canada, EU and Australia.   Fulphila®, a biosimilar Pegfilgrastim co-developed by Biocon and Mylan, was the first biosimilar Pegfilgrastim to be approved in the U.S. and was commercially launched in July 2018. It was one of the most successful biosimilar launches in the U.S. With the approval of this additional facility, Biocon Biologics and Mylan will be able to address the growing needs of patients for biosimilar Pegfilgrastim in the U.S. where introduction of the biosimilar has expanded the overall market, increasing access for patients in the U.S., as well as in other global markets. Fulphila® is also approved in other developed markets of EU, Australia and Canada.   ]]> <![CDATA[GE Healthcare unveils Edison Developer Program]]> https://biospectrumindia.com/news/95/15211/ge-healthcare-unveils-edison-developer-program.html https://biospectrumindia.com/news/95/15211/ge-healthcare-unveils-edison-developer-program.html Wed, 27 Nov 2019 11:55:00 +0530 GE Healthcare has launched the Edison Developer Program to accelerate the adoption and impact of intelligent applications and developer services across health systems. The program is based on Edison, GE Healthcare’s secure intelligence platform, and helps healthcare providers gain easier access to market-ready algorithms and applications by directly integrating these technologies into existing workflows. For developers, the Edison Developer Program offers a rich set of healthcare services to help accelerate their ability to build innovations that improve operational and clinical outcomes – and also gives them access to scale and the ability to deploy applications across GE Healthcare’s massive customer base. This program expands the existing Edison ecosystem of leading researchers, technology providers and academic institutions who develop, manage, secure and distribute advanced applications, services and AI algorithms to drive real healthcare outcomes. GE Healthcare has also unveiled several new, Edison-powered technologies, including smart devices and intelligent applications, across a variety of clinical areas. These new solutions are designed to make data, insights and clinical context more accessible and actionable across the health system, creating new value for providers and patients — from reducing costs and complexity to increasing the speed and accuracy of diagnosis. “We introduced Edison just one year ago to help health providers take advantage of data in new and significant ways,” said Kieran Murphy, President and CEO, GE Healthcare. “With the introduction of the Edison Developer Program, and a suite of new intelligent applications and smart devices powered by Edison, we are building on that promise as we continue to work with partners to realize our collective goal of advancing the future of health. ]]> <![CDATA[13th CPhI & P-MEC India Expo transforms global Pharma space]]> https://biospectrumindia.com/news/95/15205/13th-cphi-p-mec-india-expo-transforms-global-pharma-space.html https://biospectrumindia.com/news/95/15205/13th-cphi-p-mec-india-expo-transforms-global-pharma-space.html Tue, 26 Nov 2019 16:50:00 +0530 The 13th edition of South Asia’s biggest Pharma event, CPhI & P-MEC India expo, a three-day exhibition is being held from November 26th – 28th, 2019, at the India Expo Centre in Greater Noida. The event featured industry leaders from across the globe with 1,600 exhibitors from 44 countries. The gathering represented the latest developments in the pharmaceutical space across the globe. Pharmaceutical governing bodies like Pharmexcil, CIPI and IDMA supported the Expo making it yet another groundbreaking event. The expo was inaugurated by Dr Dinesh Dua, Chairman, Pharmexcil; Mahendra Mehta, President, Indian Pharmaceutical Machinery Manufacturers Association; Samir Limaye, Vice President, IPMME; Ravi Uday Bhaskar, Director-General, Pharmexcil; Dr Satish Wagh, CMD, Supriya Lifesciences; Michael Duck, Executive VP, Informa Markets in Asia, Yogesh Mudras, Managing Director, Informa Markets in India, and Rahul Deshpande, Group Director, Informa Markets in India, amidst a gathering of industry experts from across the globe.  Commenting on this year’s CPhI & P-MEC India Expo, Yogesh Mudras, Managing Director, Informa Markets in India said, “The past 12 editions of the CPhI & P-MEC India expo have paved the way for advancement in the Pharma space. It is always a pleasure for us to provide a forum to the industry leaders to present their contributions to the industry and at the same time, witness those of their peers. With a 12% growth rate annually, the India Pharmaceutical market is growing steadily, almost twice the world market growth rate. Having said that, unless we capture new market trends, innovate, adapt and seek newer opportunities, there is a risk of losing relevance in this dynamic global market. “The CPhI & P-MEC India Expo is also an inherent part of our magnum opus, India Pharma Week (IPW), an array of marquee events celebrating the pharma industry, which started its 4th edition with the Pre-Connect Congress yesterday. Always staying sensitive and true to trends, this year the theme for the IPW is ‘Adapt, Collaborate and Reinvent’, to achieve the next phase of growth for the Indian pharma domain. It is imperative to ‘Embrace Disruption to Avoid Being Disrupted’ and for the same to happen, among other factors, Indian companies need to evolve from the low-pricing approach, diversify their product range, and tap the growth potential through Clinical Trial Market, High End Drugs, Penetration into the Rural Market, and the Contract Research and Manufacturing Services (CRAMS), all of which will be discussed at length at the influential and reputable show” With the events of IPW hosted at the India Expo Centre, industry stakeholders and professionals have the liberty to attend the marquee show, network and celebrate the industry under one platform. The shift to the Delhi-NCR region has been a major factor in developing a complete pharma ecosystem in the sectoral pockets of the North, including the power corridors of the Centre. Key exhibitors at the CPhI & P-MEC India expo included ACG, Excellence United, Aurobindo Pharma, Nectar Lifesciences, Hoong-A Corporation, Supriya Lifesciences, IMA, GEA Group, Optel Group, Bosch, Bowman & Archer, Solace Engineers, Morepen Laboratories, Hetero Labs, Neogen Chemicals, Akums Drugs & Pharmaceuticals, Granules India, Acebright Pharma, Zim Laboratories, Nitika Pharmaceuticals Specialities, Scope Ingredients, Evonik India, Colorcon Asia, Pioma Chemicals, IMCD India, Accupack Engineering, Pharmalab India, Ace Technologies, Gerresheimer, Uflex, Nipro PharmaPackaging, and Indo German Pharma Engineers, among many more.   Day 1 of the expo concurrently witnessed the following events of the IPW: The CEO Roundtable: Gathering the leaders of the industry, the CEO Roundtable is a conference of change-makers of the Industry. The Roundtable featured stalwarts of the industry like Prashant Nagre, CEO, Fermenta Biotech Ltd.; Yugal Sikri, Managing Director, RPG Life Sciences Ltd.; Vivek Vasudev Kamath, Managing Director and General Manager, Abbott Specialty Care; Sanjay Kumar Jain, President , Amneal Pharmaceuticals, India; Dr. Sanjit Singh Lamba, Managing Director, Eisai Pharmaceuticals India Pvt. Ltd.; Dr. Dinesh Dua, Chairman, Nectar Lifesciences Limited; S V Veerramani, Chairman & Managing Director, Fourrts (India) Laboratories Private Limited,  among others deliberating on issues plaguing the industry and the best ways to solve them. The India Pharma Awards (IPA) & Networking Night: A Night of recognition for the champions of the Pharmaceutical space, the latest edition of the India Pharma Awards recognized the contributions of the greatest minds in the Industry. Dr. Arun Chandavarkar, CEO, Biocon, delivered the keynote address to those in attendance. ]]> <![CDATA[Alembic Pharma set to treat benign prostatic hyperplasia]]> https://biospectrumindia.com/news/95/15204/alembic-pharma-set-to-treat-benign-prostatic-hyperplasia.html https://biospectrumindia.com/news/95/15204/alembic-pharma-set-to-treat-benign-prostatic-hyperplasia.html Tue, 26 Nov 2019 16:30:00 +0530 Alembic Pharmaceuticals Limited has received final approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Silodosin Capsules, 4 mg and 8 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Rapaflo Capsules, 4 mg and 8 mg, of Allergan Sales, LLC. Silodosin capsule, a selective alpha1 adrenergic receptor antagonist, is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH). Silodosin Capsules have an estimated market size of US$ 114 million for twelve months ending June 2019 according to IQVIA. Alembic now has a total of 108 ANDA approvals (96 final approvals and 12 tentative approvals) from USFDA. ]]> <![CDATA[Glenmark receives final approval for Metformin Hydrochloride ER tablets]]> https://biospectrumindia.com/news/95/15203/glenmark-receives-final-approval-for-metformin-hydrochloride-er-tablets.html https://biospectrumindia.com/news/95/15203/glenmark-receives-final-approval-for-metformin-hydrochloride-er-tablets.html Tue, 26 Nov 2019 14:05:00 +0530 Glenmark Pharmaceuticals Inc., (Glenmark) has been granted final approval by the United States Food & Drug Administration (U.S. FDA) for Metformin Hydrochloride Extended-Release Tablets USP, 500 mg and 1000 mg, the generic version of Glumetza®1 Extended-Release Tablets, 500 mg and 1000 mg, of Salix Pharmaceuticals Inc. According to IQVIATM sales data for the 12-month period ending September 2019, the Glumetza® Tablets, 500 mg and 1000 mg market2 achieved annual sales of approximately $226.7 million. Glenmark’s current portfolio consists of 164 products authorized for distribution in the U.S. marketplace and 44 ANDA’s pending approval with the U.S. FDA. In addition to these internal filings, Glenmark continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio. ]]> <![CDATA[FDA approves novel treatment for sickle cell disease abnormalities]]> https://biospectrumindia.com/news/95/15201/fda-approves-novel-treatment-for-sickle-cell-disease-abnormalities.html https://biospectrumindia.com/news/95/15201/fda-approves-novel-treatment-for-sickle-cell-disease-abnormalities.html Tue, 26 Nov 2019 11:40:00 +0530 The U.S. Food and Drug Administration granted accelerated approval to Oxbryta (voxelotor) for the treatment of sickle cell disease (SCD) in adults and pediatric patients 12 years of age and older. "Today's approval provides additional hope to the 100,000 people in the U.S., and the more than 20 million globally, who live with this debilitating blood disorder," said Acting FDA Commissioner Adm. Brett P. Giroir, M.D. "Our scientific investments have brought us to a point where we have many more tools available in the battle against sickle cell disease, which presents daily challenges for those living with it. We remain committed to raising the profile of this disease as a public health priority and to approving new therapies that are proven to be safe and effective. Together with improved provider education, patient empowerment, and improved care delivery systems, these newly approved drugs have the potential to immediately impact people living with SCD." Nonclinical studies have demonstrated that Oxbryta inhibits red blood cell sickling, improves red blood cell deformability (ability of a red blood cell to change shape) and improves the blood's ability to flow. "Oxbryta is an inhibitor of deoxygenated sickle hemoglobin polymerization, which is the central abnormality in sickle cell disease," said Richard Pazdur, M.D., director of the FDA's Oncology Center of Excellence and acting director of the Office of Oncologic Diseases in the FDA's Center for Drug Evaluation and Research. "With Oxbryta, sickle cells are less likely to bind together and form the sickle shape, which can cause low hemoglobin levels due to red blood cell destruction. This therapy provides a new treatment option for patients with this serious and life-threatening condition." Oxbryta's approval was based on the results of a clinical trial with 274 patients with sickle cell disease. In the study, 90 patients received 1500 mg of Oxbryta, 92 patients received 900 mg of Oxbryta and 92 patients received a placebo. Effectiveness was based on an increase in hemoglobin response rate in patients who received 1500 mg of Oxbryta, which was 51.1% for these patients compared to 6.5% in the placebo group. Oxbryta was granted Accelerated Approval, which enables the FDA to approve drugs for serious conditions to fill an unmet medical need based on a result that is reasonably likely to predict a clinical benefit to patients. Further clinical trials are required to verify and describe Oxbryta's clinical benefit. The FDA granted this application Fast Track designation. Oxbryta also received Orphan Drug designation, which provides incentives to assist and encourage the development of drugs for rare diseases. The FDA granted the approval of Oxbryta to Global Blood Therapeutics. ]]> <![CDATA[Portea receives ‘Mark of Sustained Quality’ for its services in multiple cities]]> https://biospectrumindia.com/news/95/15196/portea-receives-mark-of-sustained-quality-for-its-services-in-multiple-cities.html https://biospectrumindia.com/news/95/15196/portea-receives-mark-of-sustained-quality-for-its-services-in-multiple-cities.html Mon, 25 Nov 2019 15:40:00 +0530 Portea Medical has announced that it has been awarded the ‘Mark of Sustained Quality’ by the Quality and Accreditation Institute (QAI) for a period of 3 years starting November 2019. With this, Portea Medical becomes the first home healthcare company to receive the accreditation for multiple cities including Bengaluru, Delhi, and Chennai. QAI is the gold standard for home healthcare and will help in setting standardization norms and providing accreditation to organizations in the domain. This will enable home healthcare solutions to be covered by health insurance and make it more affordable for the masses. QAI designed these standards with support of a Technical Committee comprising health industry leaders and stalwarts of home healthcare in India including Portea Medical. Speaking about this, Dr Vishal Sehgal, Medical Director, Portea Medical, said, “Home healthcare is integral in the Indian context due to many reasons. Hospital beds are always at a premium and it’s better for recovery to happen at home rather than in a hospital. Until recently, this sector was largely disorganized with no control over quality or actual registrations and qualifications of people. The QAI accreditation is thus very important for players doing actual work in this sector to be recognized for their standardized services and will help bring in more regulation. We are happy to have received the ‘Mark of Sustained Quality’. The QAI standards are a much-needed step towards standardization of home healthcare and a welcome move for the industry.” Adding further, Dr BK Rana, Founding CEO, QAI said, "Access to affordable and quality healthcare – including that within the home setup -- is the need of the hour in India. This can only be ensured when there is standardization and regulation. We at QAI have created one of the first standardization modules for home healthcare. Accredited home Healthcare is one of the key to achieve Universal health coverage. Portea Medical is not only a leader in this domain across many Indian cities but is also pioneering innovations. Their processes adhere to the highest quality standards and therefore, we are happy to accredit them with the 'Mark of Sustained Quality'. QAI will continue to recognize similar organizations going forward as well.”     The QAI standards rely on measurable criteria to ensure proper governance, competent human resources, adequate facility, appropriate information management, quality improvement opportunities and safe practices. The organization accredits home healthcare organizations by evaluating them on 69 standards and 278 parameters, spread across 9 chapters.   ]]> <![CDATA[India to grow strongly in 2020 as CPhI & P-MEC India opens]]> https://biospectrumindia.com/news/95/15192/india-to-grow-strongly-in-2020-as-cphi-p-mec-india-opens.html https://biospectrumindia.com/news/95/15192/india-to-grow-strongly-in-2020-as-cphi-p-mec-india-opens.html Mon, 25 Nov 2019 09:45:00 +0530 CPhI & P-MEC India – organised by Informa Markets – is set to open its doors from 26-29 November, at Greater Noida, to more than 43,000 attendees from 120 countries and 1,500 exhibitors, as new analysis shows a massive improvement in India’s global reputation. The India-specific findings of the CPhI Annual Report highlight the significant jumps made by the country in many categories. India showed the largest gains in terms of ‘perceived growth potential’ and ‘biologics knowledge’, proving that industry efforts to align standards more closely with the USA and Europe, as well as growth in biosimilars, have clearly been noted. But perhaps most significantly, these efforts are also being transferred into a reported increased confidence in outlook for 2020. According to the Report, India is rated as having the second highest overall growth potential of any market globally. What’s more, it also boasts the second-best score for ‘competitiveness’, and a separate report by IBEF has found that Indian pharma companies are now forecast to see exports of $20 billion in 2020. Survey respondents cited India’s ‘high-growth domestic market’ and ‘expanding manufacturing exports’ as the major drivers. The rise in exports growth potential is believed to be in response to concerted reforms by the CDSCO (Central Drugs Standard Control Organisation) and industry quality improvements in the last few years. Such was the confidence in India’s pharma market, the nation was ranked second for the ‘overall competitiveness’ of its pharma industry. India scored an average of 6.61 (out of ten), placing it behind only the US (7.03) and just above Germany (6.47). With these hugely positive results as its backdrop, the 13th Annual CPhI & P-MEC India will take place in Delhi’s India Expo Centre. The event will be held in the nation’s capital and is designed to attract a wider international audience, helping more closely integrate vital regulatory pathways into event content, and allowing an even more diverse range of partnerships. Ultimately, this empowers attendees to meet with API suppliers, distributors, contract providers and machinery specialists all in one venue. Cara Turner, Brand Director at Informa, said: “It’s such an exciting time to be working in India, with so many new opportunities now merging. This year looks set to see India’s biggest ever CPhI and that bodes extremely well for the wider industry in 2020.” The Pre-Connect Congress and the daily series of Pharma Insight Briefings in the InnoPack Theatre will deliver topical analysis to keep the industry abreast of the biggest opportunities. The CEO Roundtable is expected to be another highlight of the event. This ‘closed door’ session will deliver the discussions and conclusions that help this market to enhance its position as a global superpower in the pharma world. Encouragingly for deal-making at the event, the number of visitors and exhibitors signed up to take part in Live Pharma Connect the ‘Match and Meet’ service this year has doubled – meaning 2020 looks set to be a record-breaking year for pharma in India. In addition, a key part of Indian Pharma Week is the ‘Women in Pharma’ Forum. Under the theme of ‘Women Empowers’, this event is designed to celebrate the influential contribution of women executives in the pharmaceutical industry. This event allows women to share their stories, experience and knowledge, as they help redefine and assert the leadership role women play. Finally, P-MEC India is again playing a key role in helping this burgeoning market advance by supplying the latest technologies and machinery. Globally there has been a tremendous push to lower the cost of healthcare, with an increased use of generics and a commitment to lower manufacturing costs, improve process R&D and reduce waste. The net result of these changes is fundamentally shifting the tools we use to develop, test and manufacture the drugs of tomorrow. “As the pharma industry looks increasingly towards India for high-quality, low-cost pharma solutions, CPhI & P-MEC India is the ideal event for companies wanting to pick up on the latest trends and innovations the market has to offer. At the event you will meet the movers and shakers from India's pharma machinery, technology and ingredients industries, giving you a competitive advantage that will help grow your business,” commented Rahul Deshpande Group Director at Informa ]]> <![CDATA[The 13th edition of CPhI & P-MEC India Expo to script the growth story of global Pharma ]]> https://biospectrumindia.com/news/95/15188/the-13th-edition-of-cphi-p-mec-india-expo-to-script-the-growth-story-of-global-pharma-.html https://biospectrumindia.com/news/95/15188/the-13th-edition-of-cphi-p-mec-india-expo-to-script-the-growth-story-of-global-pharma-.html Fri, 22 Nov 2019 17:30:00 +0530 Informa Markets in India (Formerly UBM India) gears up to kick start South Asia’s largest Pharma event, CPhI & P-MEC India Expo. Driving the global pharmaceutical industry forward, the event congregates top companies across the pharma value chain. The event serves as a melting pot of ideas to drive innovation and progress for the industry. Taking the networking experience to the next level in 2019, the CPhI & P-MEC India expo over the course of three-days will begin from November 26th – 28th, 2019 at the India Expo Centre, Greater Noida, Delhi-NCR. The curated expo is supported in its by governing bodies such as Pharmexcil, CIPI and IDMA. Speaking on IPW 2019, Yogesh Mudras, Managing Director, for Informa markets in India said, “We are excited to be back to Delhi NCR for the 13th edition of CPhI & P-MEC India expo this year. The expo continues to receive an overwhelming response at the IEML, Greater Noida this year too. As the industry looks increasingly towards India for high quality, low cost pharma solutions, the expo serves as the ideal platform to pick up the latest trends and innovations that the market has to offer.  Further, the choice of location  bring us closer to the Centre, policy makers, consulates and government bodies and this will enhance our community building efforts. Apart from the business, and diverse events, key discussion areas will include ‘Growth of Indian Pharmaceutical industry, identifying the strength of collaboration for research and development of new products, embrace disruption to avoid being disrupted among many others, for the community to ruminate and act upon.” he further added “With CPhI and P-MEC India, we are proud of the way we have engaged the powerhouses of the industry to elevate their business and transform the pharma space with innovations.” With over 1,600 exhibitors from 44 countries, the expo will have special pavilions by The Global Organization for EPA and DHA (GOED), China Chamber of Commerce for Import & Export of Medicines & Health Products (CCCMHPIE), China Council for the Promotion of International Trade (CCPIT) and the Pharmaceuticals Export Promotion Council of India (Pharmexcil). The participants from the countries apart from India include China, USA, United Kingdom, Brazil, Thailand, Taiwan, France, Germany, Italy, Belgium, Switzerland, Singapore, Slovenia, Spain, UAE, Netherlands, Poland, Hong Kong, Japan and Russia. The CPhI & P-MEC India was first introduced in 2006 and is currently South Asia’s leading pharma convention. It covers every step of the supply chain, from drug discovery to finished dosage. The expo has rapidly grown over the years to become a trusted barometer of the burgeoning India pharma story, with domestic and foreign exhibitors, and visitors engaging over significant levels of business. The India Pharma Week, the umbrella event which is in its 4th year, stems from the proactive role it plays in driving key Governmental initiatives such as ‘Make in India’, ‘Start-Up India, Stand Up India’, and ‘Skill India’ connecting the global community to eke out solutions to challenges, and establishing superior standards within it. This year, the expo comprises exciting facets such as ICSE meeting Areas, a Live Pharma Connect, an Innopack Theatre and an Exhibitor Showcase among others to make the IPW a true engagement platform to Indian and global pharma companies for knowledge sharing, co-operation, collaboration, celebration and mapping the addressable issues in the industry. Further, interesting debates and sessions will be hosted as a part of The Women Leaders in Pharma which will bring the experiences to light through its Talk Show ‘Following your purpose Talking’. The discussions will cover various subjects including obstacles and hurdles faced such as underestimation, stereotyping, sexism, and marginalization, stories of women who stepped up to leadership, the underlying issues they faced, along with their practical advice for all women leaders and those who aspire to lead. Along with this, other interesting sessions will include Purposeful inclusion - Accelerating through diversity and Breaking the stereotype. Key exhibitors for the three day expo include ACG, Cadmach, IMA-PG SpA, Excellence United, NPM Machinery, Maharshi, Parle Global, Signet Chemical Corporation Pvt Ltd, Hetero Labs Limited, Shah TC Overseas Private Limited, Swati Spentose Pvt. Ltd, Chemet, Gangwal Chemicals Pvt. Ltd, Nectar Lifesciences Limited, Anshul Life Sciences, Colorcon Asia Pvt Ltd, Oceanic Pharma Chem Pvt. Ltd, Pioma Chemicals, MSN Laboratories Pvt. Ltd., Esschem Overseas Pvt. Ltd., Scope Ingredients Pvt. Ltd, Granules India Pvt. Ltd., Supriya Lifesciences Ltd., Aurobindo Pharma Ltd., Vita Pharma Agencies, and Dow Chemical.   ]]> <![CDATA[Zydus gets approval to market chest pain drug and corticosteroid cream]]> https://biospectrumindia.com/news/95/15185/zydus-gets-approval-to-market-chest-pain-drug-and-corticosteroid-cream.html https://biospectrumindia.com/news/95/15185/zydus-gets-approval-to-market-chest-pain-drug-and-corticosteroid-cream.html Fri, 22 Nov 2019 14:00:00 +0530 Zydus Cadila has received the final approval from the USFDA to market Isosorbide Dinitrate Tablets USP (US RLD – Isordil Tablet) in the strengths of 5 mg, 10 mg, 20 mg, 30 mg and 40 mg. The drug is used to prevent attacks of chest pain (angina). It dilates (widens) blood vessels, making it easier for blood to flow through them and easier for the heart to pump. It will be manufactured at the group’s formulations manufacturing facility at Baddi. The group also received the final approval for Desonide Cream (US RLD – Desonide Cream), 0.05%. The drug is a mild corticosteroid, used to treat a variety of skin conditions (e.g., eczema, dermatitis, allergies, rash) to reduce swelling, itching and redness that can occur in these types of conditions. It will be manufactured at the group’s Topical manufacturing facility at Ahmedabad. The group now has 278 approvals and has so far filed over 330 ANDAs since the commencement of the filing process in FY 2003-04. ]]> <![CDATA[Roche launches small cell lung cancer drug in India]]> https://biospectrumindia.com/news/95/15172/roche-launches-small-cell-lung-cancer-drug-in-india.html https://biospectrumindia.com/news/95/15172/roche-launches-small-cell-lung-cancer-drug-in-india.html Fri, 22 Nov 2019 07:30:00 +0530 Atezolizumab is the first cancer immunotherapy to receive an approval in India for the first line treatment of ES-SCLC when given in combination with chemotherapy. Clinical study has shown significant improvement in the survival outcomes in the patients compared to the available chemotherapy options.   The cancer immunotherapy harnesses the person’s immune system to combat cancer more effectively for better patient outcomes.  Lung cancer is one of the leading cause of cancer deaths in India. Each year around 63,000 people die as a result of the disease. Lung cancer can be broadly divided into two major types: NSCLC and SCLC, with SCLC accounting for approximately 15% of all lung cancer cases, with the majority of patients (70%) diagnosed in the “extensive stage”, often leading to poor prognosis.  “Roche is committed to bring to India all the innovations being developed in its pipeline, to benefit patients.” said Lara Bezerra, Chief Purpose Officer (Managing Director), Roche Products (India) Pvt. Ltd. “Because of the aggressive nature, rapid growth, and early development of this metastatic disease, bringing an advanced treatment with improved survival has always been a challenge. Launching Atezolizumab is an important step for SCLC patients in India and reflects our commitment to “Doing now what patients need next”.  In a clinical study Atezolizumab has demonstrated improved survival outcomes, comparable safety profile and improved the quality of life for the already approved indications, previously been approved for other two types of cancers: Non-Small Cell Lung Cancer (NSCLC) and Urothelial Carcinoma, a type of bladder and urinary tract cancer. The Phase III IMpower133 study, showed that it has significantly improved Overall Survival (OS) and Progression-free survival (PFS) for the first time in over 20 years for patients with Extensive-stage Small cell lung cancer. ]]> <![CDATA[Lupin launches generic KCl for Oral Solution USP, 20 mEq ]]> https://biospectrumindia.com/news/95/15158/lupin-launches-generic-kcl-for-oral-solution-usp-20-meq-.html https://biospectrumindia.com/news/95/15158/lupin-launches-generic-kcl-for-oral-solution-usp-20-meq-.html Wed, 20 Nov 2019 11:15:00 +0530 Lupin has announced the launch of Potassium Chloride (KCl) for Oral Solution USP, 20 mEq, having received an approval from the USFDA earlier. Lupin’s Potassium Chloride for Oral Solution USP, 20 mEq, is the generic equivalent of Pharma Research Software Solution, LLC’s Potassium Chloride for Oral Solution USP, 20 mEq, and is indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis in patients for whom dietary management with potassium-rich foods or diuretic dose reduction is insufficient. Potassium Chloride for Oral Solution USP, 20 mEq, had an annual sales of approximately USD 90 million in the U.S. (IQVIA MAT September 2019). ]]> <![CDATA[Excelra to develop novel therapeutic hypotheses in Dermatology]]> https://biospectrumindia.com/news/95/15156/excelra-to-develop-novel-therapeutic-hypotheses-in-dermatology.html https://biospectrumindia.com/news/95/15156/excelra-to-develop-novel-therapeutic-hypotheses-in-dermatology.html Wed, 20 Nov 2019 08:25:00 +0530 Hyderabad based Excelra, a leading global Data and Analytics Company has announced a Drug Repurposing collaboration with Osaka-based Maruho – a pharmaceutical company specialising in Dermatology. Under the agreement, the Drug Repurposing Data Scientists and Therapeutic area experts at Excelra will jointly work with Maruho's research team to discover and develop novel therapeutic hypotheses in Dermatology. The collaboration also gives Maruho an access to Excelra's proprietary Drug Repurposing Platform (GRIP) which comprises of proprietary Repurposing Database, Repurposing Algorithms, Analytics tools and Visualization engine. The database within GRIP has been built by amassing chemical data (over 7 million chemical entities), biological data and clinical data (over 200,000 data points) which together contribute to more than 10 million associations among 'drug-disease-target' triads. Dr. Nandu Gattu, Senior Vice President, Pharma Analytics, Excelra said, "We are excited to work with Maruho's Research team to help augment their dermatology pipeline. Together we aim at unlocking innovative treatments to improve the quality of life of millions of patients worldwide." ]]> <![CDATA[Advent to acquire majority stake in Bharat Serums ]]> https://biospectrumindia.com/news/95/15148/advent-to-acquire-majority-stake-in-bharat-serums-.html https://biospectrumindia.com/news/95/15148/advent-to-acquire-majority-stake-in-bharat-serums-.html Wed, 20 Nov 2019 05:00:00 +0530 Advent International (“Advent”), one of the largest and most experienced global private equity investors has signed a definitive agreement to acquire a majority interest in Bharat Serums and Vaccines Limited (“Bharat Serums” or “BSV”), a biopharmaceutical leader in women’s healthcare, assisted reproductive treatment, critical care and emergency medicine in India and emerging markets. With this transaction, OrbiMed PE and Kotak PE, two private equity firms that previously held minority positions in Bharat Serums, will fully exit their investments in the company. The Daftary family, which founded BSV, is retaining a meaningful equity stake in the business and is partnering with Advent on the company’s next stage of growth. Founded in 1971 in Mumbai, Bharat Serums is one of the fastest-growing biopharmaceutical companies in India. BSV researches, develops, manufactures and markets specialized injectable medicines with a portfolio focused on biotech and biological products. The company has multiple niche products that are leading brands across women’s health, assisted reproductive treatment, critical care and emergency medicine. Including the BSV acquisition, Advent has invested or committed $2.2 billion in seven companies across the healthcare industry in 2019, further expanding its depth and commitment to the sector globally. The firm has also invested or committed more than $600 million in five Indian businesses this year in sectors such as healthcare, consumer products and financial services. “Bharat Serums has a differentiated portfolio of biotech and biological offerings in high-growth segments,” said Pankaj Patwari, a Director at Advent International in Mumbai. “We are also excited about the company’s robust R&D pipeline, which offers the potential to capture whitespace both in India and global markets.” “Drawing on our deep experience in pharmaceuticals and our global platform, we see significant opportunity to further strengthen the company’s leadership position in India, particularly in women’s health, and scale its presence in emerging markets around the world,” said Shweta Jalan, a Managing Director and Head of India at Advent International in Mumbai. “Advent’s high level of investment activity in India this year demonstrates the attractiveness of the market and our commitment to investing here.” “We are thrilled to partner with Advent and continue BSV’s journey to deliver innovative and specialized products,” said Bharat V. Daftary, a member of the founding family of Bharat Serums. “Our business has demonstrated consistent product innovation and revenue growth, and with this partnership we will seek to further expand our presence in select large emerging markets. We look forward to the resources and expertise Advent will offer BSV.” Innergize Solutions acted as Strategic Advisor to BSV on the transaction. The acquisition is expected to close by the end of 2019. Financial terms were not disclosed. ]]> <![CDATA[South Asia’s largest Pharma event to kick start in India]]> https://biospectrumindia.com/news/95/15155/south-asias-largest-pharma-event-to-kick-start-in-india.html https://biospectrumindia.com/news/95/15155/south-asias-largest-pharma-event-to-kick-start-in-india.html Tue, 19 Nov 2019 15:40:00 +0530 Informa Markets in India (Formerly UBM India), a leading B2B exhibition organizer, gears up to kick start South Asia’s largest Pharma event, CPhI & P-MEC India Expo. Driving the global pharmaceutical industry forward, the event congregates top companies across the pharma value chain. The event serves as a melting pot of ideas to drive innovation and progress for the industry.  Taking the networking experience to the next level in 2019, the CPhI & P-MEC India expo over the course of three-days will begin from November 26th – 28th, 2019 at the India Expo Centre, Greater Noida, Delhi-NCR. The curated expo is supported in its endeavours by governing bodies such as Pharmexcil, CIPI and IDMA. Speaking on IPW 2019, Mr. Yogesh Mudras, Managing Director, for Informa markets in India said, “We are excited to be back to Delhi NCR for the 13th edition of CPhI & P-MEC India expo this year. The expo continues to receive an overwhelming response at the IEML, Greater Noida this year too. As the industry looks increasingly towards India for high quality, low cost pharma solutions, the expo serves as the ideal platform to pick up the latest trends and innovations that the market has to offer.  Further, the choice of location  bring us closer to the Centre, policy makers, consulates and government bodies and this will enhance our community building efforts. Apart from the business, and diverse events, key discussion areas will include ‘Growth of Indian Pharmaceutical industry, identifying the strength of collaboration for research and development of new products, embrace disruption to avoid being disrupted among many others, for the community to ruminate and act upon.” he further added “With CPhI and P-MEC India, we are proud of the way we have engaged the powerhouses of the industry to elevate their business and transform the pharma space with innovations.” With over 1,600 exhibitors from 44 countries, the expo will have special pavilions by The Global Organization for EPA and DHA (GOED), China Chamber of Commerce for Import & Export of Medicines & Health Products (CCCMHPIE), China Council for the Promotion of International Trade (CCPIT) and the Pharmaceuticals Export Promotion Council of India (Pharmexcil). The participants from the countries apart from India include China, USA, United Kingdom, Brazil, Thailand, Taiwan, France, Germany, Italy, Belgium, Switzerland, Singapore, Slovenia, Spain, UAE, Netherlands, Poland, Hong Kong, Japan and Russia. The CPhI & P-MEC India was first introduced in 2006 and is currently South Asia’s leading pharma convention. It covers every step of the supply chain, from drug discovery to finished dosage. The expo has rapidly grown over the years to become a trusted barometer of the burgeoning India pharma story, with domestic and foreign exhibitors, and visitors engaging over significant levels of business. The India Pharma Week, the umbrella event which is in its 4th year, stems from the proactive role it plays in driving key Governmental initiatives such as ‘Make in India’, ‘Start-Up India, Stand Up India’, and ‘Skill India’ connecting the global community to eke out solutions to challenges, and establishing superior standards within it. Starting from November 25th with the Pre-Connect Congress, a precursor event driven by powerful content and unmatched speakers, the scene of action will shift to Greater Noida, where turnkey engagements including the CEO Roundtable and the Women Leaders in Pharma are scheduled for 26th November and 27th November respectively. With the events of IPW hosted at the India Expo Centre, industry stakeholders and professionals will be offered the convenience to congregate at the marquee show, network and celebrate the industry under one platform. The shift to the Delhi-NCR region has helped it further develop and nurture a complete pharma ecosystem in the sectoral pockets of the North, including the power corridors of the Centre. This year, the expo comprises exciting facets such as ICSE meeting Areas, a Live Pharma Connect, an Innopack Theatre and an Exhibitor Showcase among others to make the IPW a true engagement platform to Indian and global pharma companies for knowledge sharing, co-operation, collaboration, celebration and mapping the addressable issues in the industry. Further, interesting debates and sessions will be hosted as a part of The Women Leaders in Pharma which will bring the experiences to light through its Talk Show ‘Following your purpose Talking’. The discussions will cover various subjects including obstacles and hurdles faced such as underestimation, stereotyping, sexism, and marginalization, stories of women who stepped up to leadership, the underlying issues they faced, along with their practical advice for all women leaders and those who aspire to lead. Along with this, other interesting sessions will include Purposeful inclusion - Accelerating through diversity and Breaking the stereotype. Key exhibitors for the three day expo include ACG, Cadmach, IMA-PG SpA, Excellence United, NPM Machinery, Maharshi, Parle Global, Signet Chemical Corporation Pvt Ltd, Hetero Labs Limited, Shah TC Overseas Private Limited, Swati Spentose Pvt. Ltd, Chemet, Gangwal Chemicals Pvt. Ltd, Nectar Lifesciences Limited, Anshul Life Sciences, Colorcon Asia Pvt Ltd, Oceanic Pharma Chem Pvt. Ltd, Pioma Chemicals, MSN Laboratories Pvt. Ltd., Esschem Overseas Pvt. Ltd., Scope Ingredients Pvt. Ltd, Granules India Pvt. Ltd., Supriya Lifesciences Ltd., Aurobindo Pharma Ltd., Vita Pharma Agencies, and Dow Chemical.   ]]> <![CDATA[Merck wins R&D 100 Award for First-to-Market Biopharma Purification Innovation]]> https://biospectrumindia.com/news/95/15153/merck-wins-rd-100-award-for-first-to-market-biopharma-purification-innovation.html https://biospectrumindia.com/news/95/15153/merck-wins-rd-100-award-for-first-to-market-biopharma-purification-innovation.html Tue, 19 Nov 2019 14:00:00 +0530 Merck has announced that it has received a prestigious R&D 100 Award for its Eshmuno® CP-FT Resin, a first-to-market product used in biopharmaceutical manufacturing. The R&D 100 Awards honor the 100 most innovative and significant technologies introduced in the past year. Merck has received 10 R&D 100 Awards in the past seven years. Udit Batra, CEO, Life Science at Merck said, “This award recognizes our innovation in research and development for a product that helps biomanufacturers bring new therapies to patients faster and more cost effectively,” said. “Congratulations to our extended teams, who live our purpose every day by solving the toughest problems in life science in collaboration with the global scientific community.” Aggregates are impurities in monoclonal antibody drugs that can reduce efficacy and therefore pose significant risk to patients. These impurities are challenging to remove in the purification process of drug manufacturing. Merck’s Eshmuno® CP-FT resin is a tool that removes aggregates, delivering capacities 10 times higher than traditional bind/elute chromatography. The significant reduction in resin and buffer volume results in a smaller manufacturing footprint as well as lower costs. The Eshmuno® CP-FT resin is part of Merck’s BioContinuum™ Polishing Platform. The R&D 100 Awards are among the most prestigious innovation awards in the world, honoring research and development pioneers. Merck representatives will accept the award at the 57th Annual R&D 100 Awards gala in San Francisco, California on December 5.           ]]> <![CDATA[Chiron Behring re-launches Rabies Vaccine as Chirorab]]> https://biospectrumindia.com/news/95/15106/chiron-behring-re-launches-rabies-vaccine-as-chirorab.html https://biospectrumindia.com/news/95/15106/chiron-behring-re-launches-rabies-vaccine-as-chirorab.html Thu, 14 Nov 2019 09:15:00 +0530 Chiron Behring Vaccines has announced the re-launch its purified chick embryo cell (PCEC) vaccine manufactured at its WHO pre-qualified facility in Ankleshwar, Gujarat as Chirorab®. Earlier marketed under the trade name Rabipur®, this vaccine is presently manufactured using the same technology at the same site. The vaccine is an inactivated vaccine used for active pre and post exposure immunisation against Rabies. Chiron Behring Vaccines was acquired by Bharat Biotech from GSK in March 2019 and commercial operations were restarted in May 2019. Dedicating the vaccine to India and presenting to the world, Dr. Krishna Ella said “I am proud to introduce Chirorab® to the world! We were highly committed in expediting the manufacturing and commercialisation of Chirorab® whilst maintaining the highest standards of quality to meet the urgent global requirement.” Chirorab® supplies will be made available to government hospitals in various states through tenders, with the remaining available for the private markets and exports. Dr. Ella further added “In our ongoing commitment to address the supply shortages of rabies vaccines, we are making additional investments to increase production capacity to over 15 million doses annually.” Dr. Charles Ruprecht, retired chief of the Rabies programme at CDC, Atlanta, USA and world renowned authority on Rabies said “As reflective in the mythological figure renowned in wisdom and medicine, renewed local production of the human rabies vaccine, Chirorab® should be a major opportunity for the achievement towards the 'Zero By Thirty' goal for human rabies prevention on the Indian sub-continent and the region as a whole.” The immunogenicity, efficacy, and safety of Chirorab® has been assessed in several clinical trials in pre- and post-exposure regimens, using both intramuscular and intradermal routes of administration. Chirorab® has been evaluated in over 25 controlled clinical trials in 5 countries in more than 7000 subjects. During the past 30 years, more than 80 million doses of this vaccine has been distributed worldwide with an excellent safety and efficacy profile.  According to a WHO report, rabies is a vaccine-preventable disease that claims over 59,000 lives each year, mostly in Asia and Africa. Recent studies estimate that India witnesses 17.4 million animal bites annually with 20,800 rabies deaths, being the highest in the world. India, which has a large stray dog population, reportedly needs 35 million doses of the anti-rabies vaccine per annum.    ]]> <![CDATA[Imagion Biosystems receives patent from India]]> https://biospectrumindia.com/news/95/15104/imagion-biosystems-receives-patent-from-india.html https://biospectrumindia.com/news/95/15104/imagion-biosystems-receives-patent-from-india.html Wed, 13 Nov 2019 15:40:00 +0530 Imagion Biosystems Limited, an Australian company dedicated to improving healthcare through the earlier detection of cancer, has been issued patent #320872 from the Government of India Patent Office for the Company's core intellectual property related to detection, measurement and imaging using targeted magnetic nanoparticles. The newly issued patent adds India to the Company's existing global market coverage which includes Australia, Canada, China, Israel, Japan, Russia, and the U.S. The term of the India patent extends to 2030. The number of people receiving a diagnosis of cancer in India is expected to increase from 1.15 million in 2018 to 1.41 million by 2026, according to the International Agency for Research on Cancer. Alongside this, the Indian Council of Medical Research (ICMR) has reported that breast cancer and lung cancer make up some of the most common cancers in the country, with nearly 60 per cent of breast cancer patients being diagnosed in late stages. "This is an important addition to our intellectual property portfolio," said Bob Proulx, Executive Chairman of Imagion Biosystems. "Sadly, much like the rest of the globe, the incidence of cancer in India, particularly breast cancer, is growing.  In markets like India where diagnoses often only occur in later stages, there is a huge opportunity to impact survival rates. The ability of our technology to detect cancer earlier, without the use of radiation or invasive procedures fulfills an unmet need in the diagnosis and management of cancer." Imagion Biosystems' current focus on diagnostic imaging addresses a $2 billion market worldwide. This includes breast, prostate, lung and ovarian cancer, which Imagion's MagSense technology looks to address. India will become a growing part of the addressable market due to the size of its population and its growth, and the development of cancer diagnostic technology in the country, of which MagSense seeks to be a part of. ]]> <![CDATA[Biocon Biologics debuts on the ASIA IP ELITE 2019 List]]> https://biospectrumindia.com/news/95/15102/biocon-biologics-debuts-on-the-asia-ip-elite-2019-list.html https://biospectrumindia.com/news/95/15102/biocon-biologics-debuts-on-the-asia-ip-elite-2019-list.html Wed, 13 Nov 2019 12:00:00 +0530 Biocon Ltd, an innovation-led global biopharmaceuticals company, has announced that it has been recognised as the ASIA IP ELITE for the fourth year in a row and its wholly-owned subsidiary Biocon Biologics makes its debut on this prestigious list in 2019 by the IP Business Congress Asia (IPBC Asia) for robust Intellectual Property (IP) management and consistent IP value creation. In 2016, Biocon became the first and only Indian pharmaceutical company to be featured on the prestigious ASIA IP ELITE list. This year its subsidiary Biocon Biologics, a fully integrated ‘pure play’ global biosimilars company, dedicated to developing high quality, affordable biosimilars for patients globally, has made it to the ASIA IP ELITE 2019 list, reinforcing Biocon’s commitment towards creating intellectual wealth and value for its stakeholders. Biocon Biologics received this Award at the recently concluded IP Business Congress Asia in Tokyo, Japan. Dr. Christiane Hamacher, Chief Executive Officer, Biocon Biologics, said: "We are pleased that Biocon Biologics has been inducted into the Asia IP ELITE 2019 List. This recognition is an endorsement of Biocon Group’s strategy of value creation through innovation and IP to serve patient needs across the world.  Biocon Biologics has a strong portfolio of Intellectual Property assets with granted patents and trademarks. Our IP team has demonstrated a sustained commitment to building best-in-class in-house IP function focussed on continuous excellence in IP value creation." Biocon Biologics has a product pipeline of 28 molecules, including 11 partnered with Mylan, several with Sandoz, and many being developed independently. The company’s therapeutic basket includes molecules from diabetes, oncology, immunology, dermatology, ophthalmology, neurology, rheumatology and inflammatory diseases. The companies selected as the Asia IP Elite 2019 were honoured at the latest edition of the IP Business Congress Asia, which is hosted by Intellectual Asset Management, the publishers of the world’s leading IP magazine IAM. ]]> <![CDATA[Dr. Reddy’s wins API Supplier of the Year award in Germany]]> https://biospectrumindia.com/news/95/15101/dr-reddys-wins-api-supplier-of-the-year-award-in-germany.html https://biospectrumindia.com/news/95/15101/dr-reddys-wins-api-supplier-of-the-year-award-in-germany.html Wed, 13 Nov 2019 11:05:00 +0530 At the recently held 6th Annual Global Generics & Biosimilars Awards in Frankfurt, Germany, Dr. Reddy’s has been awarded with the prestigious API Supplier of the Year. The award recognizes Dr. Reddy’s proactive and methodical approach in addressing the global sartan APIs concern.  Speaking on the achievement, Deepak Sapra, Global Head of Pharmaceutical Services and Active Ingredients’ business, commented, “Dr. Reddy's began its journey 35 years ago with the API business. Today, we are on a journey to be the world number one partner for APIs and Pharma Services. This award is a testimony to our strength in customer service, regulatory and scientific excellence, and supply of high quality APIs enabling our global pharma customers to accelerate access to affordable medicines worldwide.”  The Global Generics & Biosimilars Awards reward ‘best practice’ in both industries, as well as encourage improvements in every aspect of the way business is conducted. The award ceremony was hosted during CPhI Worldwide, on November 5th, 2019 by the Generics Bulletin. ]]> <![CDATA[Novartis inks acquisition deal with Aspen worth EUR 400M]]> https://biospectrumindia.com/news/95/15092/novartis-inks-acquisition-deal-with-aspen-worth-eur-400m.html https://biospectrumindia.com/news/95/15092/novartis-inks-acquisition-deal-with-aspen-worth-eur-400m.html Tue, 12 Nov 2019 06:40:00 +0530 Sandoz, a Novartis division, has announced that it has entered into a binding agreement for the planned acquisition of the Japanese business of Aspen Global Incorporated (AGI), a wholly owned subsidiary of Aspen Pharmacare Holdings Limited. The planned acquisition consists of shares in Aspen Japan K.K. and associated assets held by AGI. Pursuant to the agreed terms of the transaction, on closing Sandoz will pay an initial cash consideration of EUR 300 million.  Sandoz has also agreed, upon certain conditions being fulfilled after closing, to pay certain deferred consideration to AGI. It is currently anticipated that the amount of deferred consideration to be paid will not exceed EUR 100 million. Aspen’s portfolio in Japan consists of off-patent medicines with a focus on anesthetics and specialty brands. Additionally, AGI has entered into a five year manufacturing and supply agreement (with an additional two year extension option) with Sandoz, which will take effect from completion of the transaction, for the supply of active pharmaceutical ingredients, semi-finished and finished goods related to the portfolio of divested brands. Aspen’s portfolio in Japan comprises approximately 20 products, now off-patent branded medicines with a focus on anesthetics (including Xylocaine®), specialty brands (including Imuran®) and local brands. Full-year sales for the fiscal year ending in 2019 were EUR 130 million. Aspen Japan K.K. is a wholly owned subsidiary of AGI and forms part of the Aspen Group which is headquartered in Durban, South Africa. ]]> <![CDATA[Glenmark receives ANDA approval for Adapalene and Benzoyl Peroxide Gel, 0.1%|2.5% ]]> https://biospectrumindia.com/news/95/15090/glenmark-receives-anda-approval-for-adapalene-and-benzoyl-peroxide-gel-0-12-5-.html https://biospectrumindia.com/news/95/15090/glenmark-receives-anda-approval-for-adapalene-and-benzoyl-peroxide-gel-0-12-5-.html Mon, 11 Nov 2019 18:00:00 +0530 Glenmark Pharmaceuticals has been granted final approval by the USFDA for Adapalene and Benzoyl Peroxide Gel, 0.1%|2.5% It is the generic version of Epiduo®1 Gel, 0.1%|2.5%, of Galderma Laboratories L.P. According to IQVIATM sales data for the 12 month period ending September 2019, the Epiduo® Gel, 0.1%|2.5% market2 achieved annual sales of approximately $33.7 million* Glenmark’s current portfolio consists of 163 products authorized for distribution in the U.S.  marketplace and 45 ANDA’s pending approval with the USFDA.   ]]> <![CDATA[Laurus Labs gets 2 USFDA observations]]> https://biospectrumindia.com/news/95/15083/laurus-labs-gets-2-usfda-observations.html https://biospectrumindia.com/news/95/15083/laurus-labs-gets-2-usfda-observations.html Mon, 11 Nov 2019 10:25:00 +0530 Laurus Labs Limited, a leading research and development driven pharmaceutical company in India, has completed the US Food and Drug Administration (USFDA) inspection of its Unit – 2 (FDF&API integrated facility), located at APSEZ, Atchutapuram, Visakhapatnam, Andhra Pradesh, with two observations which are procedural in nature. This is a product pre-approval audit by USFDA, and no data integrity issues were observed in the inspection. “The company is pleased to announce that the USFDA inspection of its FDF & API Integrated Facility, Unit 2, at Visakhapatnam has been completed with two observations which are procedural in nature. This is a product pre-approval audit by USFDA, and no data integrity issues were observed in the inspection,” Laurus Labs said in satement. The inspection was carried out from 04 November, 2019 – 08 November, 2019. ]]> <![CDATA[Strides to relaunch Ranitidine tablets for the US Market ]]> https://biospectrumindia.com/news/95/15080/strides-to-relaunch-ranitidine-tablets-for-the-us-market-.html https://biospectrumindia.com/news/95/15080/strides-to-relaunch-ranitidine-tablets-for-the-us-market-.html Mon, 11 Nov 2019 06:00:00 +0530 Strides Pharma Science Limited (Strides or company) has announced relaunch of Ranitidine tablets for the US market. USFDA had tested numerous ranitidine tablets on the market over the past few months and released a summary of the results on November 1, 2019. The agency had indicated that if the NDMA levels were above the acceptable limits (96 nanograms per day or 0.32 ppm), they are asking companies to recall ranitidine products voluntarily. Strides’ Ranitidine Tablets 300 mg (Rx) were within the acceptable limits for NDMA of 96 nanograms per day or 0.32 ppm. Strides has now completed comprehensive testing of several of its batches available in market and in stock meeting the limits prescribed by the USFDA. Basis the outcome company has decided to relaunch its product with immediate effect.    Strides have approvals for Ranitidine tablets USP 150 mg and 300 mg. According to IQVIA MAT data, the US market for Ranitidine tablets USP 150 mg and 300 mg is ~ US$ 76 Mn. The company also has approvals for several OTC strengths but has not commercialized these products.   ]]> <![CDATA[IQVIA opens second Kochi office]]> https://biospectrumindia.com/news/95/15077/iqvia-opens-second-kochi-office.html https://biospectrumindia.com/news/95/15077/iqvia-opens-second-kochi-office.html Fri, 08 Nov 2019 12:30:00 +0530 IQVIA, the Human Data Science company, recently inaugurated its second office in Kochi, Kerala. The new facility at the World Trade Centre will house employees from IQVIA’s DSSR (Data Sciences, Safety and Regulatory) team. IQVIA’s first office in Kochi was inaugurated in early 2019 and seats employees drawn from its clinical, technology and analytics businesses. Currently IQVIA has a staff strength of over 500 in Kochi with several open positions across all its businesses. IQVIA is a world leader in using data, technology, advanced analytics and expertise to help customers drive healthcare - and human health - forward. ]]> <![CDATA[Enzene opens its first continuous biologics manufacturing facility]]> https://biospectrumindia.com/news/95/15076/enzene-opens-its-first-continuous-biologics-manufacturing-facility.html https://biospectrumindia.com/news/95/15076/enzene-opens-its-first-continuous-biologics-manufacturing-facility.html Fri, 08 Nov 2019 11:25:00 +0530 Enzene Biosciences, a subsidiary of Alkem Laboratories, has formally opened its first fully connected continuous Biologics manufacturing facility in Pune. This first-of-its-kind facility was built in half the time as compared to the conventional biologics manufacturing plants. The state-of-the-art manufacturing plant has a significantly smaller footprint than the conventional manufacturing facilities. Enzene is amongst the first movers in end-to-end connected bio manufacturing to have set up a fully automated continuous cGMP compliant manufacturing plant for mAb production. This plant as compared to a traditional manufacturing plant is capable of delivering higher production, and will also enable Enzene as well its potential clients to rapidly move their early/pre-clinical assets to the later stage of development or to the commercial stage. With this, the company lives up to it's mission of delivering cost effective biosimilars by developing disruptive technologies, advanced analytics and state-of-the-art manufacturing facility. "Some of the world's biggest drugs are biologics and Alkem laboratories Ltd. always aspired to enter the arena of biologics. With that intent, we have invested significantly into this space. Our new biologics manufacturing plant endorses our commitment to expand into the space of biotech innovations," said Mr. Sandeep Singh, the MD of Alkem Laboratories Ltd. Enzene aims to broaden its footprint for innovative technologies through strategic global alliances and has taken first steps towards it by procuring its first European client project for cGMP manufacturing of clinical material and create minimal solid waste and carbon emission.  "High cost of manufacturing is one of the major barriers for the entry of biologics into the clinical stage of development. Enzene wishes to disrupt this cost barrier through the launch of their innovative manufacturing plant," expressed Dr. Himanshu Gadgil, Whole-Time Director and CSO at Enzene. With this, Enzene Biosciences aspires to be the most sought after CDMO/CMO and aims to be a responsible corporate citizen on all aspects of environment, health and safety. ]]> <![CDATA[Sun Pharma, AstraZeneca to take novel oncology products to China ]]> https://biospectrumindia.com/news/95/15071/sun-pharma-astrazeneca-to-take-novel-oncology-products-to-china-.html https://biospectrumindia.com/news/95/15071/sun-pharma-astrazeneca-to-take-novel-oncology-products-to-china-.html Thu, 07 Nov 2019 12:55:00 +0530 Sun Pharmaceutical Industries Ltd. has announced that it has entered into a licensing agreement with AstraZeneca UK Ltd. to introduce certain novel ready-to-use (RTU) infusion oncology products in China. The agreement will help to bring cost effective and quality drugs to patients in China. As per the terms of the agreement, Sun Pharma will be responsible for development, regulatory filings and manufacturing the products covered in the agreement while AstraZeneca will exclusively promote and distribute these products in China. The initial tenure of the agreement is 10 years from the first commercial sale of the said products in China. The financial terms of the agreement are confidential. Kal Sundaram, Director of Corporate Development, Sun Pharma said, “We are pleased to partner with AstraZeneca for commercialisation of our select novel oncology products in China. AstraZeneca’s leadership position will help us to make our products available to patients and doctors in China. We see a great potential to introduce our speciality and generics products in the growing China market and this licensing agreement is another positive step in that direction.” The agreement will be announced today at the China International Import Expo (CIIE) in Shanghai. CIIE is a world-class expo that is organised by Ministry of Commerce of the People's Republic of China. It is an open cooperation platform to invite countries into China to showcase their national image and engage in international trade. ]]> <![CDATA[Lupin Q2 revenue surges by10% ]]> https://biospectrumindia.com/news/95/15065/lupin-q2-revenue-surges-by10-.html https://biospectrumindia.com/news/95/15065/lupin-q2-revenue-surges-by10-.html Thu, 07 Nov 2019 11:00:00 +0530 Pharma major Lupin Limited reported its financial performance for the quarter and six months ended September 30, 2019. These results were taken on record by the Board of Directors at a meeting held in Mumbai. Lupin announces 10 per cent rise in consolidated revenue at Rs.4,359.7 crore for the quarter ended September 30, 2019 as against Rs.3,951 crore for the corresponding quarter of last year Lupin’s September 2019 quarter (second quarter, or Q2) numbers were boosted by Rs 144 crore of income earned from licensing out a new chemical entity, but one-offs (Rs 546.5 crore) related to US lawsuits and losses on divestment in Japan pulled down the overall performance. As a result, while profit before tax and exceptional items was up 3.6 per cent year-on-year (YoY), Lupin posted a net loss of Rs 127 crore in Q2 versus a net profit of Rs 266 crore in the year-ago period. Among geographies, North America seems to be stabilising, with sales up 6.1 per cent YoY. Though the same is down sequentially, it is mainly due to the end of the exclusivity period for sales of angina treatment generics of Ranexa. Domestic sales, contributing 31 per cent to overall revenue (equal to US market’s contribution), clocked 11.5 per cent growth and emerging markets grew 8.3 per cent, providing impetus to overall sales.  During the quarter, the divestment of Kyowa CritiCare Co Ltd (KCC) was completed. This was a strategic move to streamline our Japanese operations due to limited synergy potential of KCC business with the Company’s operations. The resultant loss on divestment was Rs 167.3 crore.  Commenting on the results, Mr. Nilesh Gupta, Managing Director, Lupin Limited said, “The reported performance for the quarter was bolstered by the NCE licensing income but impacted by one-off items, adjusted for which, the operational performance was as expected. The US business has now stabilized and will grow based on ramp up of our in-line products and levothyroxine and the launch of our injectables portfolio. Markets like India continue to deliver solid growth. The next financial year is now looking very strong with important growth drivers like India, the in-line generic business in the US coupled with important launches like generic Albuterol in US and Fostair and Etanercept in Europe. Regulatory compliance remains a top organizational priority and we are making steady progress” ]]> <![CDATA[Datar Cancer Genetics offers new hope for late-stage cancer patients]]> https://biospectrumindia.com/news/95/15050/datar-cancer-genetics-offers-new-hope-for-late-stage-cancer-patients.html https://biospectrumindia.com/news/95/15050/datar-cancer-genetics-offers-new-hope-for-late-stage-cancer-patients.html Tue, 05 Nov 2019 15:50:00 +0530 Datar Cancer Genetics Limited, a molecular genomics company has announced outcomes of their ‘Resilient’ study, which offers new hope for late-stage cancer patients. The study showed that in a majority of these patients (90.5%), further progression of cancer was halted, while a significant number of patients (43%) responded to the treatment, leading to a healthy decrease in the extent of their cancers. The trials, named RESILIENT, had patients with difficult cancers receiving treatment guidance based on the Exacta solution analysis. Under this trial, 143 patients started off being given the treatment, and 126 patients were evaluable as per the study criteria. In these patients, cancer had progressed following multiple treatment failures. All patients underwent PET-CT and brain MRI scans prior to the start of the treatment. At the end of the treatment too, they were made to undergo the same scans. In an encouraging sign, while no treatment-related mortalities or critical adverse events were reported in this study, a majority of these patients reported improvement in the quality of their lives, said the ISO15189 and College of American Pathologists (CAP)-accredited Company. The approach adopted in the trial for determining the drugs that can be effective for cancer patients has been made possible through the Exacta analysis offered by Datar Cancer Genetics. It uses the technologies that analyse the DNA, RNA, proteins and circulatory tumour cells of the patient. The Exacta analysis allows for the identification of critical features of cancer. And based on the established efficacy and safety profile, certain drugs or a combination of drugs thereof are then indicated for treatment. The solution involves comprehensive in-depth tumour gene expression analysis, integration of millions of data points at the molecular level to reveal all possible targets for precision drugs, which in turn enables effective tumour burden monitoring, therapy response monitoring and detects early therapy failure or recurrence. Dr. Tim Crook, Medical Oncologist - St. Luke’s Cancer Centre, Royal Surrey County Hospital, Guildford, UK, one of the authors of the study, said, “Patients in the United Kingdom and all over the world have much to gain from the outcome of this trial.” According to Dr. Vineet Datta, another of the authors, said, “The conventional ‘Standard of Care’ approach does not take into consideration the overall genetic architecture of a particular patient’s tumour, and consequently, the patient could suffer from failed therapies or aggressive relapse. Difficult cancers do not always need new treatments; rather an intelligent approach can yield treatment benefits with existing anti-cancer drugs.” One of the most formidable challenges faced by the cancer-treating community is to be able to achieve superior clinical outcomes for refractory late-stage solid cancers among patients who have not responded positively to multiple lines of clinical therapy. The reasons for this are many. For one, some cancers become resistant to various types of drugs. And once cancer turns drug-resistant, it poses serious clinical challenges, including there being virtually no lines of treatment available to tackle it, and the outcome moving towards palliative care. In such a scenario, genetic tests serve diverse purposes, including screening and diagnosis of genetic diseases, prediction of drug responses and identifying targeted therapies to provide customised cancer care. With the benefits of genetic testing increasingly getting established, it is essential to make efforts to increase the level of access to genomic services for all who can benefit from this late-stage condition. According to the Indian Council of Medical Research (ICMR), India was home to 14 lakh cancer patients in 2016. And this number is increasing year after year. Breast cancer, cervical cancer, oral cancer, and lung cancer account for about 41 percent of the nation’s cancer burden. Of this, breast cancer is the number one killer of women, and lung cancer the top killer of men in the country.   ]]> <![CDATA[FDA approves Influenza Vaccine for older people]]> https://biospectrumindia.com/news/95/15047/fda-approves-influenza-vaccine-for-older-people.html https://biospectrumindia.com/news/95/15047/fda-approves-influenza-vaccine-for-older-people.html Tue, 05 Nov 2019 13:25:00 +0530 The U.S. Food and Drug Administration (FDA) has approved a supplemental Biologics License Application for Fluzone® High-Dose Quadrivalent (Influenza Vaccine) for use in adults 65 years of age and older. Fluzone® High-Dose (Influenza Vaccine) was approved by the FDA in 2009 as a trivalent influenza vaccine, including two influenza A strains and one influenza B strain. Fluzone High-Dose Quadrivalent contains an additional influenza B strain. Fluzone High-Dose Quadrivalent is given to people 65 years of age and older to help prevent influenza disease caused by influenza A and B strains contained in the vaccine. “Increasing protection and delivering improved influenza vaccines are critical to public health,” said David Loew, Sanofi Executive Vice President and head of Sanofi Pasteur. “We are excited to build upon the success of trivalent Fluzone High-Dose with this FDA approval to expand protection for an additional B strain. We have submitted filings with additional regulatory bodies outside the U.S. and anticipate approval in the European Union next spring.” This approval is the final step toward the company’s complete transition to quadrivalent influenza vaccines in the U.S. Fluzone High-Dose Quadrivalent will be made available for immunization efforts during the 2020-2021 influenza season. Sanofi Pasteur will continue to deliver and offer the trivalent formulation of Fluzone High-Dose through the end of the 2019-2020 influenza season. FDA approval was based on data from a Phase 3 immunogenicity and safety study, in which Fluzone High-Dose Quadrivalent achieved the primary endpoint of non-inferior immunogenicity compared to two trivalent formulations of Fluzone High-Dose, each containing one of the two influenza B strains recommended for inclusion in the vaccine for the 2017-2018 influenza season. In a secondary endpoint of the trial, each B strain in Fluzone High-Dose Quadrivalent induced a superior immune response compared to the trivalent formulation not containing the corresponding B strain. Rates of local and systemic reactions that occurred following immunization with Fluzone High-Dose Quadrivalent were similar to those induced by trivalent formulations of Fluzone High-Dose. The most common reactions occurring after administration were injection-site pain (41.3 percent), myalgia (22.7 percent), headache (14.4 percent), and malaise (13.2 percent). Onset usually occurred within the first three days after vaccination, and the majority of solicited reactions were resolved within three days of vaccination. Results from the study were published in Vaccine in September 2019. Fluzone High-Dose is the first and only influenza vaccine proven to provide superior efficacy compared to Fluzone® (Influenza Vaccine) in adults 65 years of age and older, based on results in a randomized controlled trial.This study evaluated nearly 32,000 adults 65 years of age and older over two influenza seasons in the U.S. and Canada.  Results showed that Fluzone High-Dose prevented 24 percent more cases of influenza caused by any circulating influenza strain and 51 percent more cases of influenza caused by strains similar to those contained in the vaccine compared to Fluzone. Based on data from Fluzone High-Dose, solicited injection site reactions and systemic adverse reactions were slightly more frequent after vaccination with Fluzone High-Dose compared to a standard-dose vaccine. As of the end of the 2018-2019 influenza season, over 112 million doses of Fluzone High-Dose have been distributed in the U.S. In the 2018-2019 influenza season, nearly two-thirds of U.S. adults 65 years of age and older who received an influenza vaccine received Fluzone High-Dose. ]]> <![CDATA[Biocon’s Bengaluru Facility gets EIR from U.S. FDA]]> https://biospectrumindia.com/news/95/15045/biocons-bengaluru-facility-gets-eir-from-u-s-fda.html https://biospectrumindia.com/news/95/15045/biocons-bengaluru-facility-gets-eir-from-u-s-fda.html Tue, 05 Nov 2019 11:25:00 +0530 Biocon Ltd, an innovation-led global biopharmaceuticals company, has received an Establishment Inspection Report (EIR) from the U.S. Food and Drug Administration (FDA) for its Biologics Drug Product facility in Bengaluru, stating the inspection is closed. This reaffirms Biocon Biologics’ global scale manufacturing capability for high quality, affordable biosimilars for the U.S. market. Biocon had undergone a surveillance (routine) cGMP inspection of this Drug Product facility in Bengaluru from Aug 22 to Aug 30, 2019. The receipt of EIR indicates a successful closure of this inspection. Biocon is committed to highest standards of Quality and Compliance. Dr Christiane Hamacher, CEO, Biocon Biologics said, “We are pleased to receive the EIR from the U.S. FDA for our large Biologics Drug Product facility in Bengaluru, which is a strong building block for our US$ 1 billion  revenue target. The EIR for this facility reaffirms our manufacturing capabilities for high quality biosimilars to serve the needs of patients in the U.S. Through our partner Mylan we have U.S. FDA approvals for bPegfilgrastim and bTrastuzumab, and have been making a difference to cancer patients with bPegfilgrastim. We are confident of providing an affordable alternative with commercialization of bTrastuzumab soon, leading to tremendous cost savings to the U.S. healthcare system.” The U.S. FDA in October had also approved Biocon’s new Drug Product (DP) filling line for biosimilar Trastuzumab 150 mg vials at the Biologics facility in Bengaluru, following a pre-approval Inspection (PAI) of the facility in September 2019. Biocon Biologics is uniquely positioned as a fully integrated ‘pure play’ biosimilars organization in the world, committed to enable affordable access to patients across the globe. We are targeting to serve the needs of over 2.5 million patients in FY20. We aspire to serve nearly 5 million patients and cross revenues of US$ 1 billion by FY22, driven by the near term  commercialization of Trastuzumab and Insulin Glargine in the U.S., continual growth in existing developed and emerging markets and launch of Insulin Aspart and Bevacizumab in various global markets. The Company, which has one of the broadest and deepest pipelines in the industry straddling insulins, monoclonal antibodies and other recombinant proteins, has core expertise in developing, manufacturing and commercializing high quality biosimilars. Biocon Biologics has a product pipeline of 28 molecules, including 11 with Mylan, several with Sandoz, and is developing many independently. The Company’s therapeutic basket includes molecules from diabetes, oncology, immunology, dermatology, ophthalmology, neurology, rheumatology and inflammatory diseases. In August, Biocon's Malaysia Insulin Glargine manufacturing facility received the Certificate of GMP compliance from the European Medicines Agency, expanding its capacities multi-fold to serve the needs of people with diabetes in EU. To address volume growth on account of increased penetration of its products in developed and emerging markets and also to support new biosimilar pipeline development and launches, Biocon Biologics is investing in expanding its manufacturing capacities in line with its approach of modular expansion. The company has also been undertaking strategic partnerships and acquisitions to rapidly expand its biosimilars portfolio and increase the addressable market opportunity. ]]> <![CDATA[Aurobindo gets USFDA nod for Guaifenesin Extended-Release Tablets ]]> https://biospectrumindia.com/news/95/15044/aurobindo-gets-usfda-nod-for-guaifenesin-extended-release-tablets-.html https://biospectrumindia.com/news/95/15044/aurobindo-gets-usfda-nod-for-guaifenesin-extended-release-tablets-.html Tue, 05 Nov 2019 11:05:00 +0530 Aurobindo Pharma Limited, headquartered at Hyderabad, India, manufactures generic pharmaceuticals and active pharmaceutical ingredients. Aurobindo Pharma is pleased to announce that the company has received final approval from the US Food & Drug Administration (USFDA) to manufacture Guaifenesin extended-release tablets, 600 mg and 1200 mg (OTC). Aurobindo’s Guaifenesin extended-release tablets are the AB rated generic equivalent of RB Health (US) LLC’s Mucinex® tablets. The product is expected to launch in Q4FY20. Guaifenesin extended-release tablets helps to loosen phlegm (mucus), and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive. The approved product has an estimated market size of US$ 301 million for the twelve months ending July 2019, according to IRI database. This is the 10 th ANDA (including 1 tentative approval) approved out of Unit X formulation facility in Naidupet, Andhra Pradesh, India used for manufacturing oral products. Aurobindo now has a total of 419 ANDA approvals (392 Final approvals including 21 from Aurolife Pharma LLC and 27 tentative approvals) from USFDA. ]]> <![CDATA[J&J expands efforts to help end TB in India]]> https://biospectrumindia.com/news/95/15036/jj-expands-efforts-to-help-end-tb-in-india.html https://biospectrumindia.com/news/95/15036/jj-expands-efforts-to-help-end-tb-in-india.html Mon, 04 Nov 2019 12:30:00 +0530 Johnson & Johnson has announced the expansion of its tuberculosis (TB) program in India. Through a series of new collaborations with several multilateral and non-governmental organizations (NGOs), as well as the Government of India, the company aims to help support the country’s efforts to end TB by 2025, as outlined in its National Strategic Plan for TB Elimination. A major part of Johnson & Johnson’s comprehensive 10-year initiative to achieve a world without TB, this expanded India program aims to broaden appropriate access to treatment for multidrug-resistant TB (MDR-TB), improve detection of undiagnosed cases, build critical health systems capacity, and raise awareness about TB at the community level. Earlier this month, Johnson & Johnson committed to invest $500 million over the next four years to help end the TB and HIV epidemics. “TB is a devastating disease that needlessly claims nearly half a million lives in India every year,” says Sarthak Ranade, Managing Director, Janssen India, Johnson & Johnson Private Limited. “Fortunately, we have better tools today than ever before, which offer new hope to patients, families and communities affected by TB. What is needed now – and urgently – is coordinated action. This is why we are proud to collaborate with our partners to comprehensively address the challenges presented by TB and DR-TB.” Johnson & Johnson’s Expanded TB Program in India includes: Improving diagnosis rates and linkage to care A new effort with The Foundation for Innovative New Diagnostics (FIND), in collaboration with India’s Revised National Tuberculosis Control Programme (RNTCP), will provide technical assistance to build capacity and establish new TB culture and drugsusceptibility testing facilities in at least seven sites across India – with a focus on the high-burden TB states of Maharashtra, Himanchal Pradesh and Tamil Nadu. This will help accelerate efforts to reach the WHO-recommended number of facilities in the country. Expanded funding for state governments and NGOs to enhance rates of early TB diagnosis. To date, J&J funding has enabled the provision of nearly 50,000 X-ray tests, approximately 32,000 molecular tests, and 4,600 pre-evaluation tests free-of-charge. Approximately 8,000 new TB cases and 1,000 DR-TB cases have been detected to date. Pilot initiative with TB Alert India to expand TB-control efforts in the private sector, where most patients initially seek care. This pilot project aims to strengthen the referral of patients from the private to public health system for appropriate and timely diagnosis and treatment. The model involves deployment of field staff, a dedicated call center and an online treatment adherence platform, Connect for LifeTM, developed by Johnson & Johnson to help track and support patients throughout their treatment. Training healthcare workers to improve standards of care A unique collaboration with the International Union Against Tuberculosis and Lung Disease (The Union) South-East Asia office, to support efforts aimed at building capacity of public sector healthcare providers for the effective management of TB and DR-TB. Through this project, Johnson & Johnson will support capacity building workshops & trainings and the development of training materials to improve the understanding of India’s guidelines on programmatic management of DR-TB among clinicians and healthcare workers in seven high-burden states. Ongoing efforts to elevate the standard of care for DR-TB management in the country, which to date have supported the training of more than 15,000 healthcare professionals across ten high-burden states, with plans to train an additional 5,000 healthcare professionals by 2020. Raising awareness of signs and symptoms of tuberculosis • Launch of a mass awareness and behavior-change campaign “MTV Nishedh,” in partnership with the MTV Staying Alive Foundation. Launched in September 2019, the campaign aims to place a spotlight on TB as an urgent public health issue, while at the same time helping to reduce the social stigma associated with the disease in order to prevent TB transmission and encourage patients to seek treatment. • Launch of a Metro Awareness project in Hyderabad in collaboration with local government and TB Alert India, that aims to increase awareness of TB through visual campaigns in 45 metro trains. • In addition to this, Johnson & Johnson has supported community awareness campaigns that involved 24,000 auto-rickshaws, 21,000 buses, 200 taxis, 11 trains, 7 radio stations, 112 theatre screens and 590 street plays. “Johnson & Johnson’s experience in introducing a new TB medicine shows that medicines alone are not enough to tackle AMR,” says Dr Vandita Gupta, Franchise Head, Infectious Diseases, Janssen India, Johnson & Johnson Private Limited. “We must strengthen our public health systems, train more health workers on the appropriate management of TB and DR-TB, raise community awareness, and ensure patients are diagnosed in a timely way and then successfully treated. The programs announced today form part of our broad commitment to helping India reach its ambitious goal of ending the TB epidemic by 2025.” For the past four years, Johnson & Johnson has worked with the government of India to help scale up access to bedaquiline, including by providing 22,000 courses free-of-charge as part of a donation program, coordinated in partnership with the United States Agency for International Development (USAID). ]]> <![CDATA[Lupin receives sANDA approval from USFDA for Levothyroxine Sodium Tablets]]> https://biospectrumindia.com/news/95/15028/lupin-receives-sanda-approval-from-usfda-for-levothyroxine-sodium-tablets.html https://biospectrumindia.com/news/95/15028/lupin-receives-sanda-approval-from-usfda-for-levothyroxine-sodium-tablets.html Fri, 01 Nov 2019 15:30:00 +0530 Lupin has announced the approval for its sANDA for Levothyroxine Sodium Tablets USP from the USFDA to market a generic equivalent of LEVOXYL® 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg, 200 mcg, and 300 mcg, manufactured by King Pharmaceuticals Research and Development LLC. Lupin’s Levothyroxine Sodium Tablets USP, 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg, 200 mcg, and 300 mcg was originally approved on January 18, 2019 as generic equivalent of SYNTHROID® manufactured by ABBVIE Inc. Earlier, Lupin also received sANDA approval dated September 19, 2019 for its Levothyroxine Sodium Tablets USP, 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg, 200 mcg, and 300 mcg, from the United States Food and Drug Administration (U.S. FDA), to market a generic equivalent of UNITHROID® manufactured by Jerome Stevens Pharmaceuticals Inc. With this sANDA approval, Lupin’s Levothyroxine Sodium Tablets USP, 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg, 200 mcg, and 300 mcg are now AB rated (therapeutically equivalent) with Reference Listed Drugs, SYNTHROID®, UNITHROID® and LEVOXYL® and are the only product approved with FDA’s new Narrow Therapeutic Index guidance for Levothyroxine. Lupin’s Levothyroxine Sodium Tablets are indicated for: Hypothyroidism: As replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression: As an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer ]]> <![CDATA[GSK Consumer Healthcare re-launches Crocin pain relief]]> https://biospectrumindia.com/news/95/15024/gsk-consumer-healthcare-re-launches-crocin-pain-relief.html https://biospectrumindia.com/news/95/15024/gsk-consumer-healthcare-re-launches-crocin-pain-relief.html Fri, 01 Nov 2019 09:05:00 +0530 GSK Consumer Healthcare strengthens its position in the pain relief category by re-launching the iconic Crocin Pain Relief, which is especially designed to offer relief from headaches. Delivering targeted pain relief, its formula contains clinically proven ingredients, that act at the centre of pain. Naveed Ahmed, Area Marketing Director, Wellness, GSK Consumer Healthcare said, “In today’s times when everyone has multiple priorities, dealing with a headache should never come in the way of everyday life. Keeping this in mind, GSK Consumer Healthcare is excited to re-launch Crocin Pain Relief, a solution that is specially designed as an effective yet gentle product for everyday headaches. Crocin is a household name, trusted by millions and with this launch we are confident to build on that trust further. Crocin Advance is one of the leading brands in the fever segment and with Crocin Pain Relief we are poised to win in the headache segment too”, added Ahmed. As part of the launch, the brand has released three relatable video films that bring alive the condition and its impact on peoples’ lives. The launch is being supported with an awareness campaign across television and digital platforms. The awareness plan also includes an extensive outreach to Heath care Professionals and chemists to create awareness and education on the condition and the product benefits. ]]> <![CDATA[J&J unveils next-gen monofocal intraocular lens in India]]> https://biospectrumindia.com/news/95/15022/jj-unveils-next-gen-monofocal-intraocular-lens-in-india.html https://biospectrumindia.com/news/95/15022/jj-unveils-next-gen-monofocal-intraocular-lens-in-india.html Fri, 01 Nov 2019 09:00:00 +0530 In an endeavour recognizing the need to provide solutions to post-operative cataract patients to enhance vision, Johnson & Johnson Vision, a global leader in eye health, has announced the launch of TECNIS Eyhance™ intraocular lens (IOL), a superior monofocal IOL implant for patients who have undergone cataract removal surgery procedures. This IOL is designed to extend depth of focus from distance to intermediate vision, to help meet varied modern lifestyle requirements of patients post cataract surgery. Cataract surgeries are commonly performed around the world and are considered one of the safest, most effective treatments for cataract. While older procedures required patients to wear thick lensed spectacles after the surgery, modern and technologically advanced procedures use artificial lens (or IOL). Over the past several decades, India’s eye care system has made tremendous strides towards high quality, accessible solutions to treat growing rates of preventable blindness, with cataracts being one of the leading causes. Cataract accounts for 62.6% of all preventable blindness in India. Among several solutions available, patients may opt to undergo a surgical procedure to fit an artificial lens to restore sight after removal of cloudy natural lens. “This latest innovation from Johnson & Johnson Vision defies conventional thinking about monofocal IOLs by not only delivering high-quality distance vision, but also enhancing vision and better low-light contrast. This will allow patients greater ease in performing important daily tasks which may include focusing on the car navigation system while driving, reading a sign in a store, reading TV subtitles, and walking on uneven surfaces,”  said Burzin Shahana, Country Manager at Johnson & Johnson Vision – India & South Asia. “The launch of TECNIS Eyhance™ monofocal IOL in India coincides with this month’s celebration of World Sight Day and its theme of ‘Vision First” – which resonates perfectly with Johnson & Johnson Vision’s goal of changing the trajectory of eye health and raising the standards of eye care for patients in India and around the world.” The TECNIS Eyhance™ IOL is an important first for the monofocal category, as most lenses today only correct vision to help patients see things at a distance, but do not improve intermediate vision required for many important daily tasks.  This new IOL offers breakthrough refractive design resulting in continuous increase in power from the periphery to the center of the lens and that will help patients undergoing eye surgery to experience high quality vision at both intermediate and far distances post operation allowing patients to achieve significantly improved intermediate vision, especially in low-illumination settings, compared with a standard aspheric monofocal IOL, along with 20/20 distance vision. Additionally, data has shown a low incidence of halo, glare or starburst (bright circles of light that surround headlights and other light sources) in TECNIS Eyhance™, comparable to what has been reported with the TECNIS® one-piece IOL. This product from the TECNIS® family leverages the proven design of TECNIS® one-piece platform and provides a superior solution to improved vision and eye health. In India, TECNIS Eyhance™ IOL has been approved by the Central Drugs Standard Control Organization (CDSCO). ]]> <![CDATA[Merz Aesthetics introduces evolved Ultherapy treatment to India]]> https://biospectrumindia.com/news/95/15020/merz-aesthetics-introduces-evolved-ultherapy-treatment-to-india.html https://biospectrumindia.com/news/95/15020/merz-aesthetics-introduces-evolved-ultherapy-treatment-to-india.html Thu, 31 Oct 2019 22:25:00 +0530 Every aesthetic patient’s need is different and with Ultherapy’s presence at top listed partner clinics in India, anyone can now experience the natural yet noticeable lifting effects of the first and only US FDA-cleared nonsurgical procedure for lifting the skin on your neck, chin and brow, and for improving the appearance of fine lines and wrinkles on the décolletage. The treatment was developed by one of the world’s leading aesthetics and neurotoxin companies, Merz Aesthetics which is part of the global Merz Pharma Group. Ultherapy is another of their many innovations in the field of aesthetic medicine since creating the world’s first anti-wrinkle cream in 1953. “Till date more than 1.5 million treatments have been accomplished globally with Ultherapy” said Merz Regional Commercial Director - Raymond Ong. “We’re very happy to see how it has been received, and are inspired to continue providing patients with more ways to have access to Ultherapy as Merz enjoys 111th year of existence in the industry. Also, as the world of aesthetic treatment is now moving towards a combination treatment approach, we are happy to remain the only company in the world to offer a combination of toxin, dermal fillers and energy-based devices for skin lifting & tightening to the patients”, he asserts. Since its debut in India, Ultherapy has been made available at more than 20 accredited partner clinics across all metro cities in India. “Ultherapy is a great addition to country’s beauty and wellness industry. There is great demand for non-invasive procedures, especially for skin lifting. Ultherapy answers that call for people who have mild to moderate skin laxity, those who want to ‘stay ahead of the game’ with preventive measures, and even those looking to prolong the effects of cosmetic surgery. We’re proud how Indians has responded to Ultherapy and we hope to be able to widen its reach in coming years”, said Merz India Country Manager - Manju Garg. “Indians have always believed in natural methods of taking care of their skin, likewise, Ultherapy’s procedure is non-invasive, safe and a natural way of stimulating body’s response to aging and it’s for Indians to try their hands on” she mentions. To break down this beauty breakthrough and why it’s gained a lot of popularity – Ultherapy lifts the skin using micro-focused ultrasound technology to stimulate the body’s own healing process, treating the deeper layers of the skin without disrupting or cutting the surface. The micro-focused ultrasound technology used in Ultherapy triggers the skin’s natural response, jumpstarting the regenerative process that stimulates the production of new collagen which creates a natural lifting effect. Results are visible after two to three months, and further improvements can appear up to six months after a procedure, as the collagen building process continues. Because of how convenient and flexible the treatment is, it’s no surprise that women & men of all ages and lifestyles are drawn to it. Moreover, Ultherapy works on patients ranging from as young as 20 years to as old as 70 years and more, with results lasting from anywhere between 1 year to 1.5 years after a single treatment. Since it received US FDA clearance in 2009, Ultherapy has been improving and innovating with its technology, while still maintaining its unparalleled patient safety and efficacy. "Ultherapy’s patented DeepSee visualization technology is unique as it helps a doctor to reach to the deeper skin layers and treating them without any damage to the outer layers. Other treatments either treat on the surface (e.g. lasers) or do not reach to the all the layers where treatment is required for skin tightening (e.g. radio-frequency). These treatments may also not be US FDA-cleared to lift the skin”, says Dr. Tatjana Pavicic. As a thought leader on aesthetic treatments and regarded as one of the forwards of combination treatment approach globally, Dr. Tatjana has been an advocate of an aesthetic treatment plan customized to the patient’s need.  “Aging is a result of the interplay of changes occurring in all five facial anatomical layers: skeleton, ligaments, muscles, adipose tissue, and skin. To target these, multilayer, combined intervention is required to relax, volumize, resurface, and re-drape facial skin. No single technology, filler, or neuromodulator can achieve all the results desired in treating the aging face. The question is when and how to combine different aesthetic interventions safely and effectively for the face, hands, neck, and décolletage”, she asserts. No doubt, she introduced for the first time in India, different uniquely customized treatment packages using combination treatment of Botulinum toxin, Fillers and Micro Focused Ultrasound with Visualization for fulfilling the need of Indian patients during recently organized DEEPSEE Master Course event at New Delhi organized specially for Ultherapy users in India to aid to their learning on a new Ultherapy treatment protocol and Merz Aesthetics Serendipity Journey (MASJ) treatment packages. ]]> <![CDATA[Covestro looks forward to well regulated medtech sector]]> https://biospectrumindia.com/news/95/15008/covestro-looks-forward-to-well-regulated-medtech-sector.html https://biospectrumindia.com/news/95/15008/covestro-looks-forward-to-well-regulated-medtech-sector.html Thu, 31 Oct 2019 10:00:00 +0530 Covestro, one of the world’s leading producers of advanced and high-performance polymers has welcomed the health ministry’s attention to improve safety and quality of medical devices under a single regulatory framework for all medical devices under Central Drugs Standard Control Organization (CDSCO). India has approximately 800 medical device manufacturers, but standard regulation for materials used in medical devices still remains a major concern for the health sector. Currently, only 37 categories of medical devices are regulated in India under the  Indian Medical Device Rule (IMDR 2017). India’s medical devices industry has grown from $2.2 billion to $ 5.2 billion at a compounded annual growth rate (CAGR) of 15.8%. Covestro India urges the government to chalk out a roadmap for improving the safety of medical device end-users and patients with inputs from industry experts and associations. “Since medical devices are vital to life, there is a serious need to draw mandatory guidelines to be met by every manufacturer and importer of medical devices. Advancements in medical technology require innovation in materials that help break new ground in safety and Covestro has been making healthcare future-ready with innovations in versatile polycarbonates used for diverse medical and wellness devices with direct patient contact”, says Anand Srinivasan, Head Of Polycarbonates, Covestro India. “Covestro has been providing polycarbonate material solutions to global medical device manufacturers for over 50 years . Formulation consistency, a reliable global supply network, a broad portfolio of biocompatible medical grades fulfilling ISO 10993 standards, along with strong techincal and regulatory support are provided to device manufacturers worldwide.  This helps our customers keep up with tightening medical device industry regulations while delivering innovativeproducts, including wearable devices and self administered drug delivery, for the treatment of chronic diseases,” said Dr Douglas Hamilton, Global Marketing Leader of Healthcare Industry, Polycarbonate Division. Covestro India is also making efforts to bring stakeholders of the healthcare community onto a common platform to help bring focus on increased safety of patients using medical devices. Through various initiatives, Covestro India aims to bring attention to the characterization and testing methodologies, manufacturing practices, product standards, scientific protocols, compliance criteria, ingredient specification, labeling and other technical aspects of policy criteria. ]]> <![CDATA[TB Alliance and Macleods announce commercial partnership ]]> https://biospectrumindia.com/news/95/15005/tb-alliance-and-macleods-announce-commercial-partnership-.html https://biospectrumindia.com/news/95/15005/tb-alliance-and-macleods-announce-commercial-partnership-.html Wed, 30 Oct 2019 15:05:00 +0530 Non-profit drug developer TB Alliance has granted Macleods Pharmaceuticals Limited a non-exclusive license to manufacture the anti-TB drug pretomanid as part of the three-drug “BPaL” regimen. Pending regulatory approvals, Macleods has agreed to commercialize the anti-tuberculosis (TB) medicine in approximately 140 countries and territories. Mel Spigelman, president and CEO, TB Alliance said, “TB Alliance is committed to ensuring an affordable, sustainable and competitive market for all our new TB products. We are proud to partner with Macleods, which has a strong record of delivering high-quality, affordable tuberculosis medicines.” Vijay Agarwal, business development director at Macleods said, “Our zeal to bridge unmet needs ensures that we make Tomorrow’s Medicine Available Today. This important collaboration with TB Alliance will ensure accessibility of pretomanid in countries where it is needed the most.” TB Alliance has previously collaborated with Macleods on the introduction of child-friendly formulations of first-line TB medicines. Since launched in 2015, more than one million treatment courses have been ordered by 94 countries, which represent approximately 95% of the global childhood TB burden. ]]> <![CDATA[Macleods inks drug license agreement with TB Alliance]]> https://biospectrumindia.com/news/95/15001/macleods-inks-drug-license-agreement-with-tb-alliance.html https://biospectrumindia.com/news/95/15001/macleods-inks-drug-license-agreement-with-tb-alliance.html Wed, 30 Oct 2019 07:00:00 +0530 Non-profit drug developer TB Alliance has granted Mumbai based firm Macleods Pharmaceuticals Limited a non-exclusive license to manufacture the anti-TB drug pretomanid as part of the three-drug “BPaL” regimen. Pending regulatory approvals, Macleods has agreed to commercialize the anti-tuberculosis (TB) medicine in approximately 140 countries and territories. “TB Alliance is committed to ensuring an affordable, sustainable and competitive market for all our new TB products,” said Mel Spigelman, president and CEO, TB Alliance. “We are proud to partner with Macleods, which has a strong record of delivering high-quality, affordable tuberculosis medicines.” “Our zeal to bridge unmet needs ensures that we make Tomorrow’s Medicine Available Today. This important collaboration with TB Alliance will ensure accessibility of pretomanid in countries where it is needed the most,” said Vijay Agarwal, business development director at Macleods. TB Alliance has previously collaborated with Macleods on the introduction of child-friendly formulations of first-line TB medicines. Since launched in 2015, more than one million treatment courses have been ordered by 94 countries, which represent approximately 95% of the global childhood TB burden. ]]> <![CDATA[Strides completes USFDA inspection for Alathur facility]]> https://biospectrumindia.com/news/95/14989/strides-completes-usfda-inspection-for-alathur-facility.html https://biospectrumindia.com/news/95/14989/strides-completes-usfda-inspection-for-alathur-facility.html Thu, 24 Oct 2019 16:05:00 +0530 Strides Pharma Science LTd., has announced that inspection by the US health regulator of its formulations facility in Alathur in Tamil Nadu has been completed without any adverse observations.  The company stated in the statement that, the inspection conducted in August 2019 had concluded with Zero 483 observations.  The Alathur facility manufactures solid dosage medicines, and was initially part of the company’s and Vivimed Labs’ 50:50 joint venture. Strides Pharma acquired the balance 50% from Vivimed Labs earlier this year. The facility has recently completed a significant capacity expansion and will support the growth momentum for the US business.  It has received the establishment inspection report (EIR), thereby confirming the successful closure of the inspections, the company added.  Clearance from the regulator for the facility will solve near term capacity issues for the company as its Puducherry plant is currently under remediation for violations of good manufacturing practices. ]]> <![CDATA[Cadila gets USFDA nod for Haloperidol Decanoate Injection]]> https://biospectrumindia.com/news/95/14985/cadila-gets-usfda-nod-for-haloperidol-decanoate-injection.html https://biospectrumindia.com/news/95/14985/cadila-gets-usfda-nod-for-haloperidol-decanoate-injection.html Thu, 24 Oct 2019 13:55:00 +0530 Liva Pharmaceuticals Limited, a wholly-owned subsidiary company of Cadila Healthcare Limited has received the approval from the USFDA for Haloperidol Decanoate Injection, 50 mg (base)/mL and 100 mg (base)/mL, single-dose vials, 250 mg (base)/5 mL (50 mg (base)/mL) and 500 mg (base)/5 mL (100 mg (base)/mL), multiple-dose vials (US RLD – Haldol Decanoate Injection, 50 mg (base)/mL and 100 mg (base)/mL).  It will be manufactured at Liva Pharma’s manufacturing facility at Vadodara. Haloperidol is used in the treatment of schizophrenia and for the control of tics and vocal utterances of Tourette syndrome.  The group now has 274 approvals and has so far filed over 360 ANDAs since the commencement of the filing process in FY 2003-04. ]]> <![CDATA[BioInvent signs manufacturing agreement with Cancer Research UK]]> https://biospectrumindia.com/news/95/14982/bioinvent-signs-manufacturing-agreement-with-cancer-research-uk.html https://biospectrumindia.com/news/95/14982/bioinvent-signs-manufacturing-agreement-with-cancer-research-uk.html Wed, 23 Oct 2019 17:35:00 +0530 BioInvent International AB has concluded a production agreement with Cancer Research UK, the world's largest independent funder of cancer research, for the production of Hummingbird Bioscience's anti-HER3 antibody drug HMBD-001 for use within a clinical partnership formed between Cancer Research UK and Hummingbird Bioscience to test the agent in a phase I trial. Under the agreement, which is expected to generate revenue of approximately SEK 30 million (~$3 million), mostly in 2020, BioInvent will provide HMBD-001 to Cancer Research UK. It includes process, analytical and formulation development, process scale up and manufacturing of toxicology and clinical grade material in 200- and 1,000-liters scale. "We are very pleased to have concluded an agreement to provide this service to Cancer Research UK and are looking forward to producing Hummingbird's drug candidate for clinical trials. The fact that BioInvent has its own production facility gives us added flexibility, meaning we can develop our proprietary immuno-oncology programs more efficiently, and also generate revenue from our services to help fund our pipeline," says Martin Welschof, CEO of BioInvent. Dr Nigel Blackburn, Cancer Research UK's director of drug development, says: "We are delighted to be partnering with BioInvent who will produce Hummingbird Bioscience's anti-HER3 antibody, ready to be tested in clinical trials. Our clinical development partnerships fast track promising new treatments like this through one of the most difficult stages of drug development, benefitting people with cancer much sooner." Cancer Research UK's Centre for Drug Development entered into a partnership with Hummingbird Bioscience to manufacture clinical grade anti-HER3 antibody and conduct a Phase I clinical trial to evaluate drug safety, toxicity and efficacy. HMBD-001 is the only anti-HER3 antibody in development that binds to the most critical region involved in HER3 activation, turning off this signal completely. If successful, this new antibody could be used in the treatment of multiple cancers and be effective against drug resistant cancers.   ]]> <![CDATA[Lincoln Pharma receives patent for Diclofenac Rectal Spray]]> https://biospectrumindia.com/news/95/14976/lincoln-pharma-receives-patent-for-diclofenac-rectal-spray.html https://biospectrumindia.com/news/95/14976/lincoln-pharma-receives-patent-for-diclofenac-rectal-spray.html Wed, 23 Oct 2019 10:00:00 +0530 Ahmedabad based healthcare company, Lincoln Pharmaceuticals Ltd is awarded a patent for its liquid Diclofenac Metered-Dose Rectal Spray (Diclofenac Rectal Spray). The patent has been awarded by the Government of India for “A Novel Liquid Rectal Spray Dosage Form Containing Diclofenac and Its Pharmaceutically Active Salts” This patent is valid for 20 years. The company has necessary approvals from Drug Controller General of India (DCGI) and planning to launch it in the Indian market by January 2020. The Company is also planning to apply for a Global Patent for this novel solution. As per the release, “Lincoln Pharma's Liquid rectal spray dosage offers faster and better absorption of the drug resulting in quick relief and speedy recovery to patients compared to the existing therapeutic options. Clinical Trials conducted suggest that Diclofenac Rectal Spray is highly effective in patients suffering from pre and postoperative pain, gynaecological surgery and musculoskeletal disorders such as muscular pain, pain associated with arthritis, acute pain in renal colic and mild body ache.” Speaking on this development, Mahendra Patel, Managing Director, Lincoln Pharmaceuticals Ltd, said, "Globally, No liquid formulation of diclofenac for rectal administration is available. Lincoln Pharma will be the first company to introduce this novel solution aimed at better patient compliance, rapid drug release and greater bioavailability. We have developed this formulation with Diclofenac Sodium BP 25% W/V, each squirt delivers Diclofenac Sodium 50 mg, Non-steroidal Anti-inflammatory Agent (NSAIDs). Due to this innovation, now patients can get far better results by using Diclofenac Rectal Spray as compared to the existing Diclofenac Suppository available in the market. We are planning to apply for a Global patent for this solution."  Diclofenac Rectal Suppository market is Rs. 20 crore in India and growing at 16% per annum. The company see huge export potential for this product and will start product registration in markets including African continents, Latin America and Southeast Asian markets and gradually expand to other markets. ]]> <![CDATA[Lupin receives USFDA approval for Divalproex Sodium ER Tablets USP]]> https://biospectrumindia.com/news/95/14974/lupin-receives-usfda-approval-for-divalproex-sodium-er-tablets-usp.html https://biospectrumindia.com/news/95/14974/lupin-receives-usfda-approval-for-divalproex-sodium-er-tablets-usp.html Tue, 22 Oct 2019 15:25:00 +0530 Lupin has announced that it has received approval for its Divalproex Sodium Extended-Release (ER) Tablets USP, 250 mg and 500 mg, from the United States Food and Drug Administration to market a generic equivalent of Depakote® Extended-Release Tablets, 250 mg and 500 mg, of AbbVie Inc. Lupin’s Divalproex Sodium ER Tablets USP, 250 mg and 500 mg are indicated for: Acute treatment of manic or mixed episodes associated with bipolar disorder, with or without psychotic features Monotherapy and adjunctive therapy of complex partial seizures and simple and complex absence seizures; adjunctive therapy in patients with multiple seizure types that include absence seizures Prophylaxis of migraine headaches Divalproex Sodium Extended-Release (ER) Tablets USP, 250 mg and 500 mg (RLD: Depakote® ER) had annual sales of approximately USD 159 million in the U.S. ]]> <![CDATA[AstraZeneca’s diabetes drug gets USFDA nod to ease heart failure risk]]> https://biospectrumindia.com/news/95/14968/astrazenecas-diabetes-drug-gets-usfda-nod-to-ease-heart-failure-risk.html https://biospectrumindia.com/news/95/14968/astrazenecas-diabetes-drug-gets-usfda-nod-to-ease-heart-failure-risk.html Tue, 22 Oct 2019 13:00:00 +0530 AstraZeneca has announced that the US Food and Drug Administration (FDA) has approved Farxiga (dapagliflozin) to reduce the risk of hospitalisation for heart failure (hHF) in adults with type-2 diabetes (T2D) and established cardiovascular disease (CVD) or multiple cardiovascular (CV) risk factors. The approval is based on results from the landmark DECLARE-TIMI 58 CV outcomes trial (CVOT), the largest sodium-glucose cotransporter 2 (SGLT2) inhibitor CVOT conducted to date to evaluate T2D patients with multiple CV risk factors or established CV disease.  Today’s US FDA approval follows the update to the marketing authorisation in the EU in August 2019. Farxiga is also under regulatory review in China with a decision anticipated in the first half of 2020. The US FDA has granted Fast Track designation for Farxiga to reduce the risk of CV death, or the worsening of heart failure in adults with heart failure with reduced ejection fraction (HFrEF) or preserved ejection fraction (HFpEF) based on the Phase III DAPA-HF and DELIVER trials, and Fast Track designation to delay the progression of renal failure and prevent CV and renal death in patients with chronic kidney disease (CKD) based on the Phase III DAPA-CKD trial.   ]]> <![CDATA[AstraZeneca commits $35m to reduce non-communicable diseases]]> https://biospectrumindia.com/news/95/14967/astrazeneca-commits-35m-to-reduce-non-communicable-diseases.html https://biospectrumindia.com/news/95/14967/astrazeneca-commits-35m-to-reduce-non-communicable-diseases.html Tue, 22 Oct 2019 12:25:00 +0530 AstraZeneca will extend funding for its award-winning Young Health Programme for a further five years with a pledge of $35m (£28m) to help to educate young people on the steps they can take to reduce the risk of non-communicable diseases. These diseases, which include cancer, diabetes, heart disease and heart failure, are responsible for the majority of deaths worldwide, and over two-thirds of those deaths can be directly attributed to behaviour that begins in adolescence. The Young Health Programme was launched in 2010 as the focus of AstraZeneca’s global philanthropy. It is a disease prevention programme designed to reach adolescents in under-resourced communities and work with them to reduce risk behaviours including smoking, the harmful use of alcohol, poor diet and lack of exercise. Marc Dunoyer, Chief Financial Officer, said: “Non-communicable diseases continue to be the number one cause of death worldwide, and around 70% of those deaths can be linked to behaviour that begins in adolescence. The Young Health Programme is AstraZeneca’s key philanthropic initiative that has already reached more than three million young people across the world. I’m proud to say that this extra funding will see the programme expand into Thailand, Egypt, Colombia and beyond, and reach a further five million young people by 2025.” Rose Caldwell, Chief Executive, Plan International UK, said: “Ten years ago we co-founded the Young Health Programme with AstraZeneca and at the time, we were entering a space where we knew there was a lot that needed to be done. The health of young people was not high on the global agenda and their rights were not being recognised. What we have accomplished together is a true reflection of the trust and collaboration of our partnership and learnings shared across the globe from Brazil to Indonesia. We are moving in the right direction with a marked increase in global health discussions addressing the health rights of young people and the threat of non-communicable diseases. Together over the next five years we will continue to champion the rights of young people.” The announcement comes as the One Young World Summit takes place in London, bringing together more than 2,500 young people from all over the world to highlight and discuss some of the most serious issues facing the next generation and build connections that work towards solutions. The Summit is aligned to the Sustainable Development Goals and increases awareness of the work of young people in this space. AstraZeneca’s Young Health Programme has this year provided scholarships to 25 young people from all over the world, aged 18 to 30. These scholars are global changemakers in their own right and are actively leading efforts to improve the health and wellbeing of young people in their home countries. They will attend the summit to learn, network and hear testimony from talented and motivated young people from all walks of life.   ]]> <![CDATA[Lupin targets Europe and US biosimilars market]]> https://biospectrumindia.com/news/95/14960/lupin-targets-europe-and-us-biosimilars-market.html https://biospectrumindia.com/news/95/14960/lupin-targets-europe-and-us-biosimilars-market.html Tue, 22 Oct 2019 11:05:00 +0530 Pharma major Lupin plans to launch its flagship biosimilar drug, Etarnecept along with its collaborator Mylan in Europe in July 2020.  Lupin had announced its partnership with Mylan to commercialize Lupin's etanercept biosimilar in Europe, Australia, New Zealand, Latin America, Africa and most markets throughout Asia, last year. Etarnecept is a TNF-inhibitor1 indicated to treat certain autoimmune diseases, including rheumatoid arthritis, psoriatic arthritis, plaque psoriasis and ankylosing spondylitis. Recently, Lupin received full approval to manufacture and sell YLB113, the biosimilar etanercept product, in Japan. The product is Lupin’s first biosimilar to come to the Japanese market. Dr Cyrus Karkaria, President, Biotech division, Lupin said, “After significant investment in our biotechnology division over the years, this is the first biosimilar for regulated markets developed in-house at Lupin and the first etanercept biosimilar developed by an Indian pharmaceutical player. It is an important achievement for us that sets the tone for future biosimilar development. We are planning to launch the product in Europe very soon. We are in the final stages of the approval process.” Around the same time, the company is also exploring the US market. “We are taking it cautiously and are studying the market carefully to see which drugs from our pipeline will work in the US market. We are also looking actively for collaborator for the US to understand when we take the leap”, added Dr Karkaria. ]]> <![CDATA[Lupin’s Nagpur facility receives EIR from the USFDA ]]> https://biospectrumindia.com/news/95/14947/lupins-nagpur-facility-receives-eir-from-the-usfda-.html https://biospectrumindia.com/news/95/14947/lupins-nagpur-facility-receives-eir-from-the-usfda-.html Fri, 18 Oct 2019 16:55:00 +0530 Lupin has announced the receipt of the Establishment Inspection Report (EIR) from the USFDA for its Nagpur facility. The facility was inspected by the USFDA between August 5, 2019 and August 8, 2019. The inspection for the oral solid facility at Nagpur closed without any Form 483 observation. Commenting on the receipt of the EIR, Nilesh Gupta, Managing Director, Lupin said, “Excelling at Quality and Compliance is one of our top priorities and we remain committed to meeting and exceeding standards set by regulatory agencies globally.” The Nagpur facility is Lupin’s largest and most advanced oral solid dosage facility and has maintained a solid track record of compliance. ]]> <![CDATA[Glenmark receives ANDA approval for Abiraterone Acetate Tablets USP, 250 mg]]> https://biospectrumindia.com/news/95/14939/glenmark-receives-anda-approval-for-abiraterone-acetate-tablets-usp-250-mg.html https://biospectrumindia.com/news/95/14939/glenmark-receives-anda-approval-for-abiraterone-acetate-tablets-usp-250-mg.html Fri, 18 Oct 2019 10:35:00 +0530 Glenmark Pharmaceuticals has been granted final approval by the United States Food & Drug Administration for Abiraterone Acetate Tablets USP, 250 mg, a generic version of Zytiga®Tablets, 250 mg, of Janssen Biotech, Inc. According to IQVIATM sales data for the 12 month period ending August 2019, the Zytiga® Tablets, 250 mg market2 achieved annual sales of approximately $794.1 million. Glenmark’s current portfolio consists of 162 products authorized for distribution in the U.S. marketplace and 46 ANDA’s pending approval with the U.S. FDA. ]]> <![CDATA[Cipla acquires Elores in its bid to fight AMR]]> https://biospectrumindia.com/news/95/14937/cipla-acquires-elores-in-its-bid-to-fight-amr.html https://biospectrumindia.com/news/95/14937/cipla-acquires-elores-in-its-bid-to-fight-amr.html Fri, 18 Oct 2019 10:00:00 +0530 Cipla Limited has announced the acquisition of a novel and patented anti-infective product, Elores, from Venus Remedies Limited (“VRL”) for the Indian market to further strengthen its presence in the branded Indian critical care space and as a part of its agenda to contribute to the fight against Anti-Microbial Resistance (AMR). Elores is a novel combination of Ceftriaxone (a third generation beta-lactam cephalosporin), Sulbactam (a beta-lactamase inhibitor) and Disodium EDTA (an Antibiotic Resistance Breaker) indicated for the treatment of life threatening infections caused by gram-negative bacteria. It preserves the efficacy of the antibiotic using appropriate Antibiotic Resistance Breakers (ARBs). The product was launched in India across select tertiary care hospitals in the country in 2013 after approval from the Drug Controller General of India. Umang Vohra, Managing Director and Global Chief Executive Officer, Cipla, said: “Cipla has consistently been at the forefront of promoting rational and judicious use of antibiotics, and has been a leading industry voice in the fight against AMR. Elores underscores our commitment to anti-microbial stewardship and is a significant addition to our branded portfolio of anti-infectives in India. We recently acquired ZEMDRI™, and with the acquisition of Elores, we have added to our offering of new generation antibiotics. In keeping with our purpose of Caring for Life, Elores will improve patient access to innovative quality medicines and help patients battle life-threatening resistance at critical junctures.” Saransh Chaudhary, CEO, Venus Medicine Research Centre, said: “VRL has been leading the research on novel anti-infectives in India. We’ve always viewed anti-microbial resistance (AMR) as a huge public health crisis that needs to be dealt with immediately and at all levels of the healthcare setup. Elores was our response to the problem and it has been very satisfying to see the difference that it has made in the lives of patients. I'm positive that Cipla will expand the reach of Elores to many more patients in India while ensuring a similar commitment to anti-microbial stewardship. AMR continues to be the core focus for us going forward and we hope that our consistent efforts in this space will lead to better outcomes for patients dealing with life-threatening infections.” AMR has emerged as a critical threat to public health. At the present rate, it is estimated that as many as 10 million individuals worldwide could die annually from complications related to AMR. India carries one of the largest burdens of drug-resistant pathogens worldwide. In India, Cipla has a long history of antibiotic development from ampicillin in the 1970s to quinolones in the 1990s.   ]]> <![CDATA[Cadila pharma wins compliance awards]]> https://biospectrumindia.com/news/95/14930/cadila-pharma-wins-compliance-awards.html https://biospectrumindia.com/news/95/14930/cadila-pharma-wins-compliance-awards.html Thu, 17 Oct 2019 14:35:00 +0530 The leadership team at Cadila bagged two awards on October 10, at an event hosted by Legasis group. The award ceremony honored the companies which consistently meet compliance requirements in their respective industries. Cadila Pharmaceuticals’ B.V. Suresh and Rohan Parikh were awarded for their efforts and compliance excellence.Out of 860 nominations, Cadila was chosen for two awards. B. V. Suresh was awarded the Compliance Evangelist award, an award for recognizing department heads for evangelizing the culture of compliance in their organization. Rohan Parikh was awarded the Compliance 40 under 40, an award recognizing young compliance professionals (under age 40) that have made a significant impact on their profession in achieving corporate compliances.  The jury finalized the winners based on parameters such as level of compliance in the company, timely compliances, efforts taken by the nominated person in achieving corporate compliance and cultural drive or change brought in the company for adhering compliance.“It is an honour to be the recipient of this award. We at Cadila, make it our priority to follow various guidelines and compliance to ensure the best quality of products and employees’ safety. Getting recognized for our hard work acts as a great motivator.” Shared Mr. B.V. Suresh, President, External Relations.The event witnessed the participation of 800 companies including the likes of Tata Group, Birla Group, Reliance Group, Adani Group, SBI group, GMR Group, HDFC group etc.  This recognition comes recently after Cadila Pharmaceuticals won multiple awards at TISS LeapVault Summit and awards for its learning and development initiatives and the ObserveNow Future of Workplace Award for their employee-friendly futuristic workplace. Cadila was also awarded the Brand Leadership Award and Best Employer Brand Award by CMO ASIA, the Best Warehouse Workforce Award, and WorldStar Packaging Award.Cadila Pharmaceuticals Ltd. is one of the largest privately-held pharmaceutical companies. Over the past six decades, we have been developing and manufacturing affordable medicines for patients around the world. Its innovation-led drug discovery processes ensure the health and well-being of people around the world. Being a care-focused, research-driven company, we are committed to complying with the highest ethical standard in clinical research and medical practice.   ]]> <![CDATA[Sun Pharma launches Drizalma Sprinkle in the U.S.]]> https://biospectrumindia.com/news/95/14919/sun-pharma-launches-drizalma-sprinkle-in-the-u-s-.html https://biospectrumindia.com/news/95/14919/sun-pharma-launches-drizalma-sprinkle-in-the-u-s-.html Thu, 17 Oct 2019 10:00:00 +0530 Sun Pharma including its subsidiaries and/or associate companies) today announced that one of its wholly owned subsidiaries has launched Drizalma Sprinkle™ (duloxetine delayed-release capsules) in the U.S. for oral use. Drizalma Sprinkle is a serotonin and norepinephrine reuptake inhibitor (SNRI) designed for the treatment of various neuro-psychiatric and pain disorders in patients who have difficulty swallowing – a problem that is estimated to affect approximately 30-35% of long-term care residents. The U.S. Food and Drug Administration (FDA) approved Drizalma Sprinkle on July 19,2019. The availability of Drizalma Sprinkle expands Sun Pharma’s portfolio of alternative formulation products designed for individuals with swallowing difficulties, the risk of which increases with agea nd exposure to age-related diseases and conditions - including depression, anxiety, and pain disorders. Drizalma Sprinkle joins Ezallor Sprinkle™ (Rosuvastatin) and Kapspargo Sprinkle™ (metoprolol succinate) extended-release capsules as the third product in Sun Pharma’s US portfolio designed for individuals in long-term care. It is common practice in long-term care facilities to crush medications to ease administration, but crushing tablets introduces additional risks into the administration process. The Joint Commission International Accreditation Standards for Long Term Care urges facilities to dispense medications in forms that require minimal manipulation.  “The launch of Drizalma Sprinkle is an important milestone for people with difficulty swallowing, as this formulation of duloxetine can facilitate treatment of common neuro-psychiatric disorders while preserving the quality of the medicine,” said Abhay Gandhi, CEO, North America, Sun Pharma. “This launch further underscores our commitment to providing a portfolio of alternative formulation products to treat common diseases – especially in long-term care, where 30-35% of individuals have difficulty swallowing. These patients often encounter medication errors and challenges with medication administration.” Drizalma Sprinkle is indicated for the treatment of major depressive disorder (MDD) in adults, generalized anxiety disorder (GAD) in adults and pediatric patients 7-17 years old, diabetic peripheral neuropathic pain (DPNP) in adults, and chronic musculoskeletal pain in adults. It is available in four dosage strengths (20mg, 30mg, 40mg, and 60mg). Drizalma Sprinkle is the first and only FDASun Pharmaceutical Industries Ltd.   ]]> <![CDATA[Morepen Labs adds three new drugs to API portfolio ]]> https://biospectrumindia.com/news/95/14909/morepen-labs-adds-three-new-drugs-to-api-portfolio-.html https://biospectrumindia.com/news/95/14909/morepen-labs-adds-three-new-drugs-to-api-portfolio-.html Wed, 16 Oct 2019 08:00:00 +0530 New Delhi based Morepen Laboratories Ltd. has developed and added three blockbuster drugs to its portfolio of Active Pharmaceutical Ingredients (APis) for sale in domestic and global markets. The three bulk drugs / APis are Rivaroxa ban (trade nameXarelto), Vildagliptin (trade names- Galvus, Zomelis) and UDCA (Ursodeoxycholic Acid). While two products Rivaroxaban and Yildagliptin will augment Morepen's presence in the Cardiac and Diabetic segments respectively, the third product UDCA will cater to the Liver segment. The current global market size for Rivaroxaban, a powerful anticoagulant (blood thinner), is $7.1 9Billion (Rs. 51,000 cores) and that ofVildagliptin, which is a strong oral Anti-diabetic drug used for the treatment of type 2 diabetes, is $1.28 Billion (Rs. 9,000 cores). The global market size for Rivaroxaban is likely to touch $9.00 Billion(Rs. 64,000 crore) by year 2023 and that of Yildagliptin $1.35 Billion (Rs. 9,600 crore) by 2021 . Morepen Labs will initially target patent free markets for these two drugs globally. The Drug Master File (DMF) for regulatory markets like US etc will be filed within the next 12 months' time frame. ]]> <![CDATA[Eli Lilly presents positive results for Taltz in Plaque Psoriasis patients]]> https://biospectrumindia.com/news/95/14898/eli-lilly-presents-positive-results-for-taltz-in-plaque-psoriasis-patients.html https://biospectrumindia.com/news/95/14898/eli-lilly-presents-positive-results-for-taltz-in-plaque-psoriasis-patients.html Mon, 14 Oct 2019 13:05:00 +0530 Eli Lilly and Company has announced that Taltz met co-primary endpoints as well as all major secondary endpoints in a Phase 3 study in pediatric patients with moderate to severe plaque psoriasis, demonstrating that 89 percent of patients treated with Taltz achieved a significant 75 percent improvement from baseline to Week 12 on their Psoriasis Area and Severity Index score (PASI 75) and 81 percent of patients treated with Taltz achieved a static Physician's Global Assessment of clear or almost clear skin (sPGA 0,1). Results of the study are being presented as a late-breaking oral presentation at the European Academy of Dermatology and Venereology Congress (EADV) in Madrid, Spain. Based on these positive results, Lilly plans to submit for U.S. regulatory approval for pediatric patients with moderate to severe plaque psoriasis. "Results from our study indicate that Taltz may have the potential to clear skin and reduce itch in pediatric patients with moderate to severe plaque psoriasis," said study investigator Kim Papp, MD, PhD, Probity Medical Research, Inc., Waterloo, Ontario, Canada. "While it is estimated that up to one third of people with psoriasis first develop symptoms during childhood, there are limited medications available for pediatric patients. This study provides encouraging data supporting the potential for Taltz to become another treatment option for this patient population." "We recognize that psoriasis can have a significant impact on children and adolescents, causing challenging symptoms and affecting their self-esteem and ability to connect to peers," said Lotus Mallbris, M.D., Ph.D., vice president of immunology development at Lilly. "We're pleased to see positive results for Taltz in pediatric patients. These results build on more than five years of safety and efficacy data in adults and support the potential for Taltz in this new population, pending regulatory approvals." In this trial, the overall safety profile of Taltz was consistent with previously reported results. The Taltz safety profile has been studied across 15 clinical trials in plaque psoriasis and psoriatic arthritis, with 6,989 patients receiving Taltz, with a total exposure of 16,586 patient-years. ]]> <![CDATA[FDA approves Eli Lilly's migraine treatment]]> https://biospectrumindia.com/news/95/14896/fda-approves-eli-lillys-migraine-treatment.html https://biospectrumindia.com/news/95/14896/fda-approves-eli-lillys-migraine-treatment.html Mon, 14 Oct 2019 12:30:00 +0530 Eli Lilly and Company has announced that USFDA has approved REYVOW™ (lasmiditan) an oral medication for the acute treatment of migraine, with or without aura, in adults. REYVOW has a unique mechanism of action and is the first and only FDA-approved medicine in a new class of acute treatment for migraine (serotonin (5-HT)1F receptor agonists). Gudarz Davar, M.D., vice president, neurology development, Lilly Bio-Medicines said, "Millions of people with migraine face an ongoing battle with the unresolved pain and symptoms of a migraine attack. There is a substantial unmet need for new acute treatments for migraine, like REYVOW, which is why we are proud of today's approval and Lilly's continuing contribution to the migraine community. New expectations have been set in migraine care; pain freedom is now the treatment goal for people living with migraine and those who treat them. At Lilly, we are pioneering innovative medicines to provide new options for patients with migraine." As with other medicines with central nervous system (CNS) activity, the FDA required abuse potential studies for REYVOW. Abuse potential refers to the likelihood that abuse will occur with a particular drug product or substance with CNS activity. Consistent with the FDA's guidance, Lilly conducted a human abuse potential assessment; as part of that assessment, therapeutic doses of REYVOW were associated with less drug liking when compared to alprazolam, but more than placebo. The recommended controlled substance classification for REYVOW is currently under review by the Drug Enforcement Administration (DEA) and is expected within 90 days of today's FDA approval, after which REYVOW will be available to patients in retail pharmacies. Jan Brandes, M.D., MS, FAAN, assistant clinical professor, Department of Neurology, Vanderbilt University said, "As a physician who specializes in the treatment of migraine and headache disorders, I commonly treat patients who are looking for acute treatment options that offer the chance for pain freedom during migraine attacks. This approval is especially significant because migraine pain is so often severe and incapacitating. With new science comes new hope. Considering up to 40% of people with migraine do not get adequate responses from their initial acute treatment prescription, having a new and novel option like REYVOW is an important development for physicians and the patients we treat.” Patrik Jonsson, senior vice president and president, Lilly Bio-Medicines said, "For over 25 years, Lilly has been committed to helping people affected by disabling headache disorders, investigating more than a dozen different compounds. The approval of REYVOW is an exciting development for patients and physicians seeking the potential for pain freedom when a migraine attack happens." REYVOW is a new oral treatment that binds to 5-HT1F receptors with high affinity and is approved by the FDA for the acute treatment of migraine, with or without aura, in adults. Its therapeutic effects are presumably mediated by agonist effects at this receptor; however, the precise mechanism is unknown.   ]]> <![CDATA[Sun Pharma launches CEQUA for dry eyes treatment in the US]]> https://biospectrumindia.com/news/95/14892/sun-pharma-launches-cequa-for-dry-eyes-treatment-in-the-us.html https://biospectrumindia.com/news/95/14892/sun-pharma-launches-cequa-for-dry-eyes-treatment-in-the-us.html Mon, 14 Oct 2019 11:15:00 +0530 Sun Pharmaceutical Industries Ltd. has announced that one of its wholly-owned subsidiaries has commercialized CEQUA (cyclosporine ophthalmic solution) 0.09% in the U.S. CEQUA, which offers the highest concentration of cyclosporine for ophthalmic use approved by the U.S. Food and Drug Administration (FDA), is indicated to increase tear production in patients with keratoconjunctivitis sicca (dry eye), an inflammatory disease that afflicts more than 16 million people in the U.S.  CEQUA is the first and only FDA-approved cyclosporine treatment delivered with nanomicellar (NCELL™) technology, which helps to improve the bioavailability and physicochemical stability of cyclosporine, resulting in improved ocular tissue penetration. Sun Pharma is also introducing CEQUA SUPPORT™ Specialty Pharmacy, a program designed to enable commercially insured patients to easily obtain CEQUA. Once a patient’s prescription is submitted, CEQUA SUPPORT will provide several important services including insurance plan benefits verification, prior authorization support, and appeals assistance. This program is structured to minimize out-of-pocket cost and provides free home delivery. ]]> <![CDATA[MaxiVision acquires Sharat laser Eye hospital ]]> https://biospectrumindia.com/news/95/14890/maxivision-acquires-sharat-laser-eye-hospital-.html https://biospectrumindia.com/news/95/14890/maxivision-acquires-sharat-laser-eye-hospital-.html Fri, 11 Oct 2019 14:15:00 +0530 MaxiVision has acquired Sharat laser Eye hospital of Warangal and carved its way to be the leader in Eye health care in India. This joint venture will covet leadership in Indian vision care segment with chain of super speciality eye hospitals across the country. The new Joint venture has been named as ”Sharat MaxiVision eye hospital” after it has forged an alliance with Sharat laser Eye hospital of Warangal. Speaking on the Occasion Dr GSK Velu - Chairman, MaxiVision Super Speciality Eye hospitals group & Trivitron Healthcare, said, “With the new Joint venture MaxiVision has emerged as an undisputed leader in eye care sector in both the telugu states i.e Telangana & Andhra Pradesh and aims high to be the second largest eye care services provider in India in the years to come. We are happy to forge an alliance with Dr Sarath Babu Chilukuri, a leading eye care practitioner, in district of Warangal and joined hands to this enterprise.” “Dr Sharath is one of the largest eye care practice in Warangal, with Super Speciality technology, and specialists. Dr Sharath Eye hospital is one of the first eye hospitals to have NABH accreditation amongst eye care players in the region. He is also actively involved in various academic and research forums, and conduct advanced surgical training programs for budding ophthalmologists in India and Overseas. With over 400 people walking in to his enterprise for eye care, he need additional strengths to grow his enterprise to other districts of Telangana and AP, which was his vision over past decade”, he added. With this strategic merger, the vision of reaching out quality eye care to every district of Telangana & Andhra will be achieved. Dr Sharath will forge his strengths, expertise and knowledge to MaxiVision group, to augment the journey of becoming one of India’s Largest Eye Care Chain. Dr.Sharath, will add value to MaxiVision group in its expansion plans in the region, and also initiate training and academic projects for the group. He will be partnering Dr.Kasu Prasad Reddy, in all clinical strategies, and technology induction to the group, to benefit the people of twin states of Telangana and Andhra. The expansion spree in Joint venture will continue to redefine the competitive landscape. As a successful entrepreneur in joint venture MaxiVision aims to launch 15 more hospitals by 2021 in JV. Warangal, Karimnagar, Khammam, Miryalaguda hospitals will be launched by end of 2019.We target MaxiVision to be seen as a 500 crores group company in the next 5 years. MaxiVision has forged a vision plan ‘EMERGE’ to grow its network to other parts of Hyderabad City, over 10 districts in Telangana and AP and spread its network to neighbouring states of Tamilnadu, Kerala and Karnataka, from 2020. This will elevate MaxiVision Group of Eye Hospitals, to be 2nd largest chain of eye care hospital in India, from the current position of 4th largest eye care chain in the country. Elaborating more on the acquisition Dr Kasu Prasad Reddy, Founder Mentor, Co-Chairman, MaxiVision Super Specialty Eye hospitals group said, “25 years ago I came back from England to give the best of eye care service to my state which educated me the values and knowledge to what I am today. With a non-compromising ethical practice over the years, my practice grew beyond the capacity of an Individual eye care service provider. Joining hands with Dr Velu, and my expert team of doctors has helped grow my practice even better, and spread to various locations. The need of the clinical partner arose to the current vision of MaxiVision to be a national player, and timing couldn’t be better than this, for entry of Dr Sharath, an exemplary young surgeon, with a vision to grow, to this growing group. Together under the guidance and leadership of Dr. GSK Velu, and a team of professionals, this group will grow to the vision in short time” Speaking on the Occasion, Dr Sharath babu chilukuri added, “I have been always carrying a vision in my mind to grow my practice to tier 2 and Tier 3 towns of Telangana and Andhra Pradesh. After the bifurcation of the state, and emerging new towns, and population, the need of eye care is growing ominously, in all pockets of these two states. Watching MaxiVision grow its own as an undisputed leader, in Telangana and AP, I decided to partner with them, forge energies and grow together with a network of super specialty eye care provider. I am convinced that Dr.GSK Velu, a dynamic health care entrepreneur, Dr.Kasu Prasad Reddy, who is a guru and example for many Opthalmologists like me, we will be very successful in this journey.” Giving more insights on Maxivision, Sudheer, COO said, “The success of any health care service provider, is the best combination of clinical and strategic business management expertise. The objective of any ethical health care service provider is to give the best outcome out of surgeries of procedures. This require extensive clinical knowledge and expertise, and a strategic input to invest on right technology, at right time, in right place, on right price, for best results.Today MaxiVision has 11 State of the art eye hospitals across Telangana and AP. Maxivision also hosts all the latest Super Specialty eye care technology, to treat entire gamut of eye diseases.  For the last 25 years MaxiVision has treated over 4 million eyes with the best super specialty surgeons in the state. This Joint Venture will carry forward the legacy of maxiVision to other parts of the country and acquire more like minded successful practices to combine positive vision and grow to be a leader in eye care in India.”     ]]> <![CDATA[Biocon, Evotec sign licensing deal for biosimilar asset]]> https://biospectrumindia.com/news/95/14881/biocon-evotec-sign-licensing-deal-for-biosimilar-asset.html https://biospectrumindia.com/news/95/14881/biocon-evotec-sign-licensing-deal-for-biosimilar-asset.html Fri, 11 Oct 2019 09:00:00 +0530 Biocon Limited and Evotec SE have announced that Biocon Biologics, a wholly owned subsidiary of Biocon Ltd, and Just - Evotec Biologics, wholly owned by Evotec, have entered into a strategic licensing agreement for an early-stage, pre-clinical biosimilar asset. Biocon Biologics will take this biosimilar asset through end-to-end development, IND filing, manufacturing and commercialization post-regulatory approval, under its own label in global markets. Biocon Biologics aims to address the needs of a large patient pool through this differentiated therapy. Through this in-licensing deal, Biocon Biologics has expanded its current therapeutic basket of biosimilars going beyond diabetes, oncology and immunology. Just – Evotec Biologics has a unique platform with deep experience in the fields of protein, process and manufacturing sciences, which it has leveraged to develop this complex molecule. Just – Evotec Biologics has received an undisclosed license fee from Biocon Biologics and will be eligible to receive development, regulatory and commercial milestone payments. Dr Christiane Hamacher, CEO, Biocon Biologics, said: “We are extremely confident of the quality of the biosimilar asset developed by Just – Evotec Biologics and this collaboration will provide a head start for Biocon Biologics to commercialize a biosimilar under its own brand. Leveraging our R&D skills and manufacturing expertise, we aim to take this differentiated therapy from ‘bench to bedside.’ This product expands our therapeutic basket and will enable us to address unmet patient needs for a high quality affordable therapy.” Dr James N. Thomas, EVP, Global Head Biotherapeutics & President US Operations at Just - Evotec Biologics, said: “We are excited to enter into this partnership with Biocon Biologics, a multinational company with a strong presence in biosimilars. Just – Evotec Biologics’ optimised product and process platform has generated an excellent early-stage product candidate which we have licensed to Biocon Biologics for further development using their late-stage development, manufacturing and commercial capabilities to bring a compelling treatment to patients. We look forward to providing support to the Biocon Biologics team as their program advances towards the clinic.” “This is the beginning of a great relationship between Just – Evotec Biologics and Biocon Biologics,” Dr Thomas added. Under the agreement, Biocon Biologics will now assume all development and commercialization responsibilities for the program. Biocon Biologics will benefit from Just – Evotec Biologics’ vast experience in the process development domain particularly with respect to optimised manufacturability. R&D is at the core of Biocon Biologics' journey towards meeting its strategic long-term goal of addressing the needs of millions of patients worldwide. Biocon Biologics’ scientific expertise and world class R&D and manufacturing facilities have enabled it to bring multiple biosimilar therapeutics to the US and Europe. Biocon Biologics has a product pipeline of 28 molecules, including 11 with Mylan, several with Sandoz, and is developing many independently. The Company’s therapeutic basket includes molecules from diabetes, oncology, immunology, dermatology, ophthalmology, neurology, rheumatology and inflammatory diseases. Financial details of the licensing transaction have not been disclosed. ]]> <![CDATA[ Sun Pharma's FDEC initiative wins recognition]]> https://biospectrumindia.com/news/95/14877/-sun-pharmas-fdec-initiative-wins-recognition.html https://biospectrumindia.com/news/95/14877/-sun-pharmas-fdec-initiative-wins-recognition.html Thu, 10 Oct 2019 15:25:00 +0530 The Malaria Elimination Demonstration Project (MEDP) started by the Foundation for Disease Elimination and Control of India (FDEC India) was conferred with the Mahatma Award for Social Good 2019 at the 'Mahatma Awards’ ceremony held at Gurgaon, Delhi NCR as part of Mahatma Gandhi’s 150th Birth Anniversary. FDEC India, has been established by Sun Pharma as part of its Corporate Social Responsibility initiative. MEDP was started in September 2017 as a Public Private Partnership between FDEC India, the Indian Council of Medical Research (ICMR) and the Government of Madhya Pradesh. The Mahatma Awards, constituted in 2017 in the United States, are presented annually to honor and popularizing the social good impact of thousands of individuals and organizations. The awards are given to individuals, NGOs, nonprofits, corporations and public sector enterprises, who are working towards sustainable development goals set by United Nations.   The goal of MEDP is to demonstrate successful elimination of malaria from 1233 villages of Mandla district in Madhya Pradesh. Within 24 months of operations, FDEC India has achieved 83% reduction in indigenous cases in the entire district and 90% reduction in high endemic blocks. The project involves robust surveillance through the T4 approach - Track, Test, Treat and again Track to eliminate malaria.  ]]> <![CDATA[Glenmark receives tentative ANDA approval for MS drug]]> https://biospectrumindia.com/news/95/14875/glenmark-receives-tentative-anda-approval-for-ms-drug.html https://biospectrumindia.com/news/95/14875/glenmark-receives-tentative-anda-approval-for-ms-drug.html Thu, 10 Oct 2019 13:25:00 +0530 Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted tentative approval by the United States Food & Drug Administration (U.S. FDA) for Dimethyl Fumarate Delayed-Release Capsules, 120 mg and 240 mg, a generic version of Tecfidera®1 Capsules, 120 mg and 240 mg, of Biogen Inc. It is used for treating multiple sclerosis. According to IQVIATM sales data for the 12 month period ending August 2019, the Tecfidera® Capsules, 120 mg and 240 mg market2 achieved annual sales of approximately $3.7 billion. Glenmark’s current portfolio consists of 161 products authorized for distribution in the U.S. marketplace and 49 ANDA’s pending approval with the U.S. FDA. In addition to these internal filings, Glenmark continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio. ]]> <![CDATA[Zydus gets final USFDA approval for Colesevelam Hydrochloride Tablets ]]> https://biospectrumindia.com/news/95/14874/zydus-gets-final-usfda-approval-for-colesevelam-hydrochloride-tablets-.html https://biospectrumindia.com/news/95/14874/zydus-gets-final-usfda-approval-for-colesevelam-hydrochloride-tablets-.html Thu, 10 Oct 2019 13:00:00 +0530 Zydus Cadila has received the final approval from the USFDA to market Colesevelam Hydrochloride Tablets, (US RLD - Welchol), 625 mg. This medication is used along with a proper diet and exercise, to lower cholesterol in people with high levels of cholesterol in the blood. Lowering cholesterol decreases the risk of heart disease and helps prevent strokes and heart attacks. It will be manufactured at the group’s formulations manufacturing facility at SEZ, Ahmedabad. The group now has 273 approvals and has so far filed over 360 ANDAs since the commencement of the filing process in FY 2003-04. ]]> <![CDATA[MaxiVision aims to be a Rs 500Cr group company by 2024]]> https://biospectrumindia.com/news/95/14872/maxivision-aims-to-be-a-rs-500cr-group-company-by-2024.html https://biospectrumindia.com/news/95/14872/maxivision-aims-to-be-a-rs-500cr-group-company-by-2024.html Thu, 10 Oct 2019 12:05:00 +0530 MaxiVision has added another feather in its cap as it has acquired Sharat laser Eye hospital of Warangal and carved its way to be the leader in Eye health care in India. This dynamic joint venture will covet leadership in Indian vision care segment with chain of super speciality eye hospitals across the country .  MaxiVision group are the pioneers in  various cutting edge eye care  technologies  while Dr. Sharat and his team of doctors under Dr Sharat laser eye hospital is fore runner in eye care services in Telangana.The new Joint venture has been named  as ”Sharat MaxiVision eye hospital” after it has forged an alliance today with Sharat laser Eye hospital of Warangal. Speaking on the Occasion Dr. GSK Velu - Chairman, MaxiVision Super Speciality Eye hospitals group & Trivitron Healthcare, said with the new Joint venture MaxiVision has emerged as an undisputed leader in eye care sector in both the telugu states i.e Telangana & Andhra Pradesh and aims high to be the second largest eye care services provider in India in the years to come. We are happy to forge an alliance with Dr.Sarath Babu Chilukuri, a leading eye care practitioner, in district of Warangal and joined hands to this enterprise. Dr.Sharath is one of the largest eye care practice in Warangal, with Super Speciality technology, and specialists. Dr. Sharath Eye hospital is one of the first eye hospitals to have NABH accreditation amongst eye care players in the region. He is also actively involved in various academic and research forums, and conduct advanced surgical training programs for budding ophthalmologists in India and Overseas. With over 400 people walking in to his enterprise for eye care, he need additional strengths to grow his enterprise to other districts of Telangana and AP, which was his vision over past decade. With this strategic merger, the vision of reaching out quality eye care to every district of Telangana & Andhra will be achieved. Dr. Sharath will forge his strengths, expertise and knowledge to MaxiVision group, to augment the journey of becoming one of India’s Largest Eye Care Chain. Dr. Sharath, will add value to MaxiVision group in its expansion plans in the region, and also initiate training and academic projects for the group. He will be partnering Dr.Kasu Prasad Reddy, in all clinical strategies, and technology induction to the group, to benefit the people of twin states of Telangana and Andhra.  The expansion spree in Joint venture will continue to redefine the competitive landscape. As a successful entrepreneur in joint venture MaxiVision aims to launch 15 more hospitals by 2021 in JV. Warangal, Karimnagar, Khammam, Miryalaguda hospitals will be launched by end of 2019.We target MaxiVision to be seen as a 500 crores group company in the next 5 years.MaxiVision has forged a vision plan ‘EMERGE’ to grow its network to other parts of Hyderabad City, over 10 districts in Telangana and AP and spread its network to neighbouring states of Tamilnadu, Kerala and Karnataka, from 2020. This will elevate MaxiVision Group of Eye Hospitals, to be 2nd largest chain of eye care hospital in India, from the current position of 4th largest eye care chain in the country.  Elaborating more on the acquisition Dr. Kasu Prasad Reddy, Founder Mentor, Co-Chairman, MaxiVision Super Speciality Eye hospitals group said the “ 25 years ago I came back from England to give the best of eye care service to my state which educated me the values and knowledge to what I am today. With a non-compromising ethical practice over the years, my practice grew beyond the capacity of an Individual eye care service provider. Joining hands with Dr.Velu,and my expert team of doctors has helped grow my practice even better, and spread to various locations. The need of the clinical partner arose to the current vision of MaxiVision to be a national player, and timing couldn’t be better than this, for entry of Dr.Sharath, an exemplary young surgeon, with a vision to grow, to this growing group. Together under the guidance and leadership of Dr.GSK Velu, and a team of professionals, this group will grow to the vision in short time”.  Speaking on the Occasion, Dr. Sharath babu chilukuri  added “ I have been always carrying a vision in my mind to grow my practice to tier 2 and Tier 3 towns of Telangana and Andhra Pradesh. After the bifurcation of the state, and emerging new towns, and population, the need of eye care is growing ominously, in all pockets of these two states. Watching MaxiVision grow its own as an undisputed leader, in Telangana and AP, I decided to partner with them, forge energies and grow together with a network of super specialty eye care provider. I am convinced that Dr.GSK Velu, a dynamic health care entrepreneur, Dr.Kasu Prasad Reddy, who is a guru and example for many Opthalmologists like me, we will be very successful in this journey. Giving more insights on Maxivision, Sudheer, COO said, “The success of any health care service provider, is the best combination of clinical and strategic business management expertise. The objective of any ethical health care service provider is to give the best outcome out of surgeries of procedures. This require extensive clinical knowledge and expertise, and a strategic input to invest on right technology, at right time, in right place, on right price, for best results. Today MaxiVision has 11 State of the art eye hospitals across Telangana and AP. Maxivision also hosts all the latest Super Specialty eye care technology, to treat entire gamut of eye diseases.  For the last 25 years MaxiVision has treated over 4 million eyes with the best super specialty surgeons in the state. This Joint Venture  will carry forward the legacy of maxiVision to other parts of the country and acquire more like minded successful practices to combine positive vision and grow to be a leader in eye care in India.   ]]> <![CDATA[Novartis receives FDA approval for Beovu]]> https://biospectrumindia.com/news/95/14865/novartis-receives-fda-approval-for-beovu.html https://biospectrumindia.com/news/95/14865/novartis-receives-fda-approval-for-beovu.html Wed, 09 Oct 2019 16:10:00 +0530 Novartis announced that the U.S. Food and Drug Administration (FDA) approved Beovu® (brolucizumab) injection, also known as RTH258 for the treatment of wet age-related macular degeneration (AMD). Beovu is the first FDA approved anti-VEGF to offer both greater fluid resolution versus aflibercept and the ability to maintain eligible wet AMD patients on a three-month dosing interval immediately after a three-month loading phase with uncompromised efficacy. “Beovu meets our goals in clinical practice for treating wet AMD: improving vision and drying retinal fluid,” said Dr. Pravin U. Dugel, Managing Partner, Retinal Consultants of Arizona; Clinical Professor, Roski Eye Institute, Keck School of Medicine, University of Southern California; and principal investigator of the HAWK clinical trial. “With Beovu, greater fluid reduction was demonstrated through larger decreases in retinal thickness and a higher proportion of patients with drier retinas. Coupled with the potential to treat patients with quarterly injections, this approval may change the way we approach the treatment of wet AMD.” The approval of Beovu was based on findings from the Phase III HAWK and HARRIER clinical trials, in which Beovu demonstrated non-inferiority versus aflibercept in mean change in best-corrected visual acuity (BCVA) at year one (week 48). Wet AMD is a chronic, degenerative eye disease caused by an excess of VEGF, a protein that promotes the growth of abnormal blood vessels underneath the macula, the area of the retina responsible for sharp, central vision. Fluid that leaks out of these abnormal blood vessels disrupts the normal retinal structure and ultimately damages the macula. The Beovu molecule is engineered to deliver the highest concentration of drug, providing more active binding agents than other anti-VEGFs. By inhibiting VEGF, Beovu suppresses the growth of abnormal blood vessels and the potential for fluid leakage into the retina. Beovu exhibited an overall safety profile comparable to aflibercept. Beovu is contraindicated in patients with ocular or periocular infections, active intraocular inflammation or with known hypersensitivity to brolucizumab or any of the excipients in Beovu.  Hypersensitivity reactions may manifest as rash, pruritus, urticaria, erythema or severe intraocular inflammation.  With this approval, Novartis is offering BEOVU Your WayTM in the U.S. This program provides personalized, one-on-one support for patients and caregivers, with access to a care specialist committed to understanding patients’ unique needs and preferences. Novartis is proud to be partnering with patient advocacy organizations to deliver educational materials for patients and caregivers, with the goal of empowering wet AMD patients to live safely and independently ]]> <![CDATA[Japan’s PMDA issues GMP Certificate to Lupin’s Unit II Mandideep facility]]> https://biospectrumindia.com/news/95/14864/japans-pmda-issues-gmp-certificate-to-lupins-unit-ii-mandideep-facility.html https://biospectrumindia.com/news/95/14864/japans-pmda-issues-gmp-certificate-to-lupins-unit-ii-mandideep-facility.html Wed, 09 Oct 2019 14:35:00 +0530 Lupin has announced the receipt of GMP (Good Manufacturing Practice) Certificate from the Pharmaceutical and Medical Devices Agency (PMDA), Japan for its Mandideep API facility (Unit II). The GMP Certificate was issued following an inspection conducted by PMDA between May 14, 2019 and May 17, 2019. The PMDA inspection closed with no critical or major observations. The GMP Certificate issued by PMDA for Mandideep facility (Unit II) is valid till September 2024. ]]> <![CDATA[Glenmark receives tentative ANDA approval for generic version of Tecfidera® Capsules ]]> https://biospectrumindia.com/news/95/14862/glenmark-receives-tentative-anda-approval-for-generic-version-of-tecfidera-capsules-.html https://biospectrumindia.com/news/95/14862/glenmark-receives-tentative-anda-approval-for-generic-version-of-tecfidera-capsules-.html Wed, 09 Oct 2019 14:05:00 +0530 Glenmark Pharmaceuticals has been granted tentative approval by the United States Food & Drug Administration for Dimethyl Fumarate Delayed-Release Capsules, 120 mg and 240 mg, a generic version of Tecfidera® Capsules, 120 mg and 240 mg, of Biogen Inc. According to IQVIATM sales data for the 12 month period ending August 2019, the Tecfidera® Capsules, 120 mg and 240 mg market achieved annual sales of approximately $3.7 billion. Glenmark’s current portfolio consists of 161 products authorized for distribution in the US marketplace and 49 ANDA’s pending approval with the USFDA. ]]> <![CDATA[Alembic Pharma gets USFDA approval for generic Clobex spray]]> https://biospectrumindia.com/news/95/14843/alembic-pharma-gets-usfda-approval-for-generic-clobex-spray.html https://biospectrumindia.com/news/95/14843/alembic-pharma-gets-usfda-approval-for-generic-clobex-spray.html Mon, 07 Oct 2019 15:55:00 +0530 Alembic Pharmaceuticals Limited, a vertically integrated research and development pharmaceutical company, announces its joint venture Aleor Dermaceuticals receives Approval from US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Clobetasol Propionate Spray, 0.05%.  The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Clobex® Spray, 0.05% of Galderma Laboratories L.P. (Galderma). Clobetasol Propionate Spray, 0.05% is indicated for the treatment of moderate to severe plaque psoriasis affecting up to 20% body surface area (BSA) in patients 18 years of age or older. Clobetasol Propionate Spray, 0.05%, has an estimated market size of US$ 22 million for twelve months ending December 2018 according to IQVIA. Alembic has a cumulative total of 103 ANDA approvals (91 final approvals and 12 tentative approvals) from USFDA.   ]]> <![CDATA[Lupin launches Mycophenolate Mofetil Capsules USP]]> https://biospectrumindia.com/news/95/14839/lupin-launches-mycophenolate-mofetil-capsules-usp.html https://biospectrumindia.com/news/95/14839/lupin-launches-mycophenolate-mofetil-capsules-usp.html Fri, 04 Oct 2019 16:35:00 +0530 Pharma major Lupin Limited (Lupin) announced the launch of Mycophenolate Mofetil Capsules USP, 250 mg. Lupin’s alliance partner Concord Biotech Limited (Concord) had received an approval from the United States Food and Drug Administration (U.S. FDA) earlier. Mycophenolate Mofetil Capsules USP, 250 mg, is the generic version of Roche’s CellCept®. Mycophenolate Mofetil Capsules are an antimetabolite immunosuppressant indicated for the prophylaxis of organ rejection in recipients of allogeneic kidney, heart or liver transplants, and should be used in combination with other immunosuppressants. Mycophenolate Mofetil Capsules USP, 250 mg, had annual sales of approximately USD 53 million in the U.S. (IQVIA MAT August 2019).   ]]> <![CDATA[Novartis and Microsoft to transform medicine with AI]]> https://biospectrumindia.com/news/95/14816/novartis-and-microsoft-to-transform-medicine-with-ai.html https://biospectrumindia.com/news/95/14816/novartis-and-microsoft-to-transform-medicine-with-ai.html Thu, 03 Oct 2019 10:55:00 +0530 Novartis has announced an important step in reimagining medicine by founding the Novartis AI innovation lab and by selecting Microsoft as its strategic AI and data-science partner for this effort. The new lab aims to bolster Novartis AI capabilities from research through commercialization and help accelerate the discovery and development of transformative medicines for patients worldwide. As part of the strategic collaboration announced, Novartis and Microsoft have committed to a multi-year research and development effort. This strategic alliance will focus on two core objectives: 1) AI Empowerment. The lab will aim to bring the power of AI to the desktop of every Novartis associate. By bringing together vast amounts of Novartis datasets with Microsoft’s advanced AI solutions, the lab will aim to create new AI models and applications that can augment our associates’ capabilities to take on the next wave of challenges in medicine.  2) AI Exploration. The lab will use the power of AI to tackle some of the hardest computational challenges within life sciences, starting with generative chemistry, image segmentation & analysis for smart and personalized delivery of therapies and optimization of cell and gene therapies at scale. Microsoft and Novartis will also collaborate to develop and apply next-generation AI platforms and processes that support future programs across these two focus areas. The overall investment will include project funding, subject-matter experts, technology, and tools.  Vas Narasimhan, CEO of Novartis, said, “As Novartis continues evolving into a focused medicines company powered by advanced therapy platforms and data science, alliances like this will help us deliver on our purpose to reimagine medicine to improve and extend patients’ lives. Pairing our deep knowledge of human biology and medicine with Microsoft’s leading expertise in AI could transform the way we discover and develop medicines for the world.” Microsoft CEO, Satya Nadella, added, “Our strategic alliance will combine Novartis' life sciences expertise with the power of Azure and Microsoft AI. Together, we aim to address some of the biggest challenges facing the life sciences industry today and bring AI capabilities to every Novartis employee so they can unlock new insights as they work to discover new medicines and reduce patient costs.” ]]> <![CDATA[Biocon, Mylan launch Semglee in Australia]]> https://biospectrumindia.com/news/95/14817/biocon-mylan-launch-semglee-in-australia.html https://biospectrumindia.com/news/95/14817/biocon-mylan-launch-semglee-in-australia.html Thu, 03 Oct 2019 10:55:00 +0530 Biocon Ltd and Mylan N.V.  have announced the launch of Semglee® (insulin glargine solution for injection 100 IU/mL in a 3mL pre-filled pen), the first insulin glargine biosimilar in Australia available on the Pharmaceutical Benefits Scheme (PBS). Insulin glargine is a long-acting basal insulin analogue, given once daily to help control the blood sugar levels of those with diabetes. It is indicated for the treatment of type 1 diabetes mellitus in adults, adolescents and children aged six years and above and type 2 diabetes mellitus in adults. Diabetes is recognised as the world’s fastest growing chronic condition and is the biggest challenge confronting Australia’s health system. Almost two million Australians have diabetes, with 280 Australian developing diabetes every day – one person every five minutes. The total annual cost impact of diabetes in Australia is estimated at $14.6 billion. More affordable treatment options for healthcare providers and their patients, such as biosimilars, generate savings that help manage the growing costs of Australia’s health care system, particularly the PBS. The Government recognises the importance of driving biosimilar uptake to create a competitive and sustainable biosimilars market. In 2015, the Government committed to the Biosimilar Awareness Initiative and in 2018 increased its commitment by supporting the Generic and Biosimilar Medicines Association through a $5 million grant to undertake activities that further promote the appropriate prescribing, dispensing and use of biosimilar medicines. Dr Christiane Hamacher, CEO, Biocon Biologics said, “We are extremely excited to enable affordable access to Semglee, a high quality biosimilar Insulin Glargine, co-developed and manufactured by Biocon Biologics, to people with diabetes in Australia. We are committed to use our science, scale and expertise to shift the access paradigm for patients in need of insulins across the globe. As a leading global insulins player, Biocon has been addressing the needs of patients with diabetes for over 15 years and we are confident that availability of Semglee through the Pharmaceutical Benefits Scheme will expand patient access to this therapy in Australia and will reduce the cost burden for PBS.  Today, patients in Europe, India and key emerging markets are already benefiting from our biosimilar Insulin Glargine.” Mylan Australia Country Manager, Sylvain Vigneault commented, "The launch of Semglee further demonstrates Mylan’s ongoing commitment to increase access to biosimilars for patients. Biosimilars mark a new era in treatment. They enable more patients to be treated, deliver significant savings to the PBS and help provide sustainability to the healthcare system overall. “We are delighted that Semglee enables Mylan to strengthen and support its global diabetes and metabolism portfolio of approximately 400 products.” Biosimilars have been used safely and effectively in Europe, USA, Australia and many other countries. Since 2006, in the EU alone, over 700 million patient days of clinical experience to more than 20 biosimilar medicines have been recorded. TGA approval of Semglee, co-developed by Biocon and Mylan, was based on robust data that demonstrated that Semglee is highly similar to the reference insulin glargine, with no clinically meaningful differences in efficacy, safety, purity and potency. Mylan and Biocon's insulin glargine biosimilar is currently approved in more than 40 countries around the world.  ]]> <![CDATA[Lupin gets FDA nod for Extended Phenytoin Sodium capsules ]]> https://biospectrumindia.com/news/95/14810/lupin-gets-fda-nod-for-extended-phenytoin-sodium-capsules-.html https://biospectrumindia.com/news/95/14810/lupin-gets-fda-nod-for-extended-phenytoin-sodium-capsules-.html Tue, 01 Oct 2019 15:25:00 +0530 Pharma major Lupin Limited (Lupin) announced that it has received approval for its extended Phenytoin Sodium Capsules USP, 100 mg, from the United States Food and Drug. Administration (U.S.FDA), to market a generic equivalent of Dilantin® 100 mg, of Parke-Davis, division of Pfizer Inc.  Lupin’s Extended Phenytoin Sodium Capsules USP, 100 mg, are indicated for: Treatment of tonic-clonic (grand mal) and psychomotor (temporal lobe) seizures Prevention and treatment of seizures occurring during or following neurosurgery  Extended Phenytoin Sodium Capsules USP,100 mg (RLD: Dilantin®) had annual sales of approximately USD 105 million in the U.S. (IQVIA MAT June 2019). ]]> <![CDATA[AstraZeneca selects N-SIDE suite for clinical trials ]]> https://biospectrumindia.com/news/95/14808/astrazeneca-selects-n-side-suite-for-clinical-trials-.html https://biospectrumindia.com/news/95/14808/astrazeneca-selects-n-side-suite-for-clinical-trials-.html Tue, 01 Oct 2019 12:30:00 +0530 N-SIDE, provider of innovative software and strategic consulting services, announced that AstraZeneca has signed an agreement to implement the N-SIDE Suite for Clinical Trials. Within the scope of this agreement, AstraZeneca will use specifically the N-SIDE Supply and Dashboard Apps in order to design, plan and monitor their clinical trial supply chain. John Murray, Supply Chain Transformation Lead at AstraZeneca, commented: “N-SIDE’s Suite provides a tremendous opportunity for AstraZeneca to collaborate across key areas of clinical development and deliver the best studies for our patients." Thanks to the N-SIDE Suite for Clinical Trials, AstraZeneca will achieve a centralization of their clinical supply chain management. The N-SIDE solution will support both strategic decision-making during protocol design as well as operational planning and change management of on-going trials. The business intelligence dashboards will be used for real-time trial monitoring, results visualization and supporting cross-department communication. "We are proud to further our collaboration with AstraZeneca as they implement the N-SIDE Suite for Clinical Trials to manage their clinical supply chain” stated Jacques Parlongue, N-SIDE CEO. N-SIDE has provided consulting services for AstraZeneca clinical trial supply optimization since 2017. The N-SIDE Suite for Clinical Trials is a cutting edge, cloud-based software that enables clinical trial managers to future-proof their clinical trial supply chain management while minimizing costs, drug waste and risk. With interconnected applications, the N-SIDE Suite for Clinical Trials uses advanced analytics, including optimization and machine learning, to support strategic and operational decision-making as well as facilitate trial monitoring with real-time data and knowledge sharing. ]]> <![CDATA[Lupin launches Sildenafil Tablets USP]]> https://biospectrumindia.com/news/95/14806/lupin-launches-sildenafil-tablets-usp.html https://biospectrumindia.com/news/95/14806/lupin-launches-sildenafil-tablets-usp.html Tue, 01 Oct 2019 12:10:00 +0530 Lupin has announced the launch of Sildenafil Tablets USP, 25 mg, 50 mg, and 100 mg, having received an approval from the United States Food and Drug Administration earlier. Lupin’s Sildenafil Tablets USP, 25 mg, 50 mg, and 100 mg, is the generic version of Pfizer Inc’s Viagra® Tablets, 25 mg, 50 mg, and 100 mg. Sildenafil Tablets are a phosphodiesterase-5 (PDE5) inhibitor and are indicated for the treatment of erectile dysfunction (ED). Sildenafil Tablets USP, 25 mg, 50 mg, and 100 mg had an annual sales of approximately USD 216 million in the US (IQVIA MAT July 2019). ]]> <![CDATA[Lupin launches Sildenafil Tablets USP ]]> https://biospectrumindia.com/news/95/14799/lupin-launches-sildenafil-tablets-usp-.html https://biospectrumindia.com/news/95/14799/lupin-launches-sildenafil-tablets-usp-.html Mon, 30 Sep 2019 17:25:00 +0530 Pharma major Lupin Limited (Lupin) announced the launch of Sildenafil Tablets USP, 25 mg, 50 mg, and 100 mg, having received an approval from the United States Food and Drug Administration (U.S. FDA) earlier.  Lupin’s Sildenafil Tablets USP, 25 mg, 50 mg, and 100 mg, is the generic version of Pfizer Inc’s Viagra® Tablets, 25 mg, 50 mg, and 100 mg. Sildenafil Tablets are a phosphodiesterase-5 (PDE5) inhibitor and are indicated for the treatment of erectile dysfunction (ED).  Sildenafil Tablets USP, 25 mg, 50 mg, and 100 mg had an annual sales of approximately USD 216 million in the US (IQVIA MAT July 2019).   ]]> <![CDATA[Glenmark receives approval from Russia to market Montlezir ]]> https://biospectrumindia.com/news/95/14793/glenmark-receives-approval-from-russia-to-market-montlezir-.html https://biospectrumindia.com/news/95/14793/glenmark-receives-approval-from-russia-to-market-montlezir-.html Mon, 30 Sep 2019 14:30:00 +0530 Glenmark Pharmaceuticals has announced the approval from the Ministry of Healthcare, Russia to market Montlezir (Levocetirizine Dihydrochloride 5mg + Montelukast Sodium 10mg) film-coated tablets as a prescription product for the treatment of seasonal and perennial allergic rhinitis in patients above 15 years of age. Montlezir is expected to be available in the Russian market in Q3 FY 2019-20. Csaba Kantor, Senior Vice President and Head - Asia, Russia & CIS region, Glenmark Pharmaceuticals said, “Glenmark has built strong capabilities in the area of respiratory and is among the leading players in this therapy area across several markets globally. Russia is one of the key markets for us and we are consistently looking to expand our product portfolio. We believe that approval for Montlezir will help enhance our presence in this segment.” Oxana Pozdnyakova, Vice President and Business Head – Russia, Glenmark Pharmaceuticals said, “Allergic rhinitis affects a significant number of people in Russia, and we already have a number of products in our portfolio for the treatment of this condition. The approval to market Montlezir will further strengthen our company’s position in this segment and we are delighted to be able to bring new products to the market for patients suffering from this condition." According to IQVIA, Glenmark ranked 47th in the retail segment of the Russian pharmaceutical market as of MAT July 2019. ]]> <![CDATA[Strides receives USFDA approval for Solifenacin Succinate tablets ]]> https://biospectrumindia.com/news/95/14787/strides-receives-usfda-approval-for-solifenacin-succinate-tablets-.html https://biospectrumindia.com/news/95/14787/strides-receives-usfda-approval-for-solifenacin-succinate-tablets-.html Fri, 27 Sep 2019 17:20:00 +0530 Strides Pharma Science Limited (Strides) has announced that its step‐down wholly owned subsidiary, Strides Pharma Global Pte. Limited, Singapore,  has received approval for Solifenacin Succinate Tablets, 5 mg and 10 mg  from the United  States  Food  &  Drug  Administration  (USFDA). The  product  is  a  generic  version  of  Vesicare  Tablets, 5 mg and 10 mg, of Astellas Pharma US, Inc.   According to IQVIA MAT data, the US market for Solifenacin Succinate Tablets, 5 mg and 10  mg  is  approximately  US$  820 Mn.  The  product  will  be manufactured  at  Alathur  facility  in Chennai and will be marketed by Strides Pharma Inc. in the US market.      The company has 102 cumulative ANDA  filings with USFDA of which 66 ANDAs have been  approved and 36 are pending approval.  Solifenacin Succinate Tablet is an antispasmodic indicated for the  treatment  of  overactive  bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency. ]]> <![CDATA[Zydus’ Clobetasol Propionate Lotion gets final USFDA nod ]]> https://biospectrumindia.com/news/95/14781/zydus-clobetasol-propionate-lotion-gets-final-usfda-nod-.html https://biospectrumindia.com/news/95/14781/zydus-clobetasol-propionate-lotion-gets-final-usfda-nod-.html Fri, 27 Sep 2019 15:10:00 +0530 Zydus Cadila is an innovative, global pharmaceutical company that discovers, develops, manufactures and markets a broad range of healthcare therapies. Zydus Cadila has received the final approval from the USFDA to market Clobetasol Propionate Lotion, (US RLD - Clobex Lotion), 0.05%. This medication is used to treat a variety of skin conditions like eczema, psoriasis, dermatitis, allergies and rash. Clobetasol reduces the swelling, itching and redness that can occur in these types of conditions. It will be manufactured at the group’s Topical manufacturing facility at Ahmedabad. The group now has 272 approvals and has so far filed over 360 ANDAs since the commencement of the filing process in FY 2003-04. ]]> <![CDATA[Biocon announces price reduction for insulin]]> https://biospectrumindia.com/news/95/14777/biocon-announces-price-reduction-for-insulin.html https://biospectrumindia.com/news/95/14777/biocon-announces-price-reduction-for-insulin.html Fri, 27 Sep 2019 10:50:00 +0530 Kiran Mazumdar-Shaw, CMD, Biocon has promised to enable universal access to rh-Insulin by reducing prices to less than 10 US cents /Day for Low and middle income countries which bear the 80% diabetes burden. The Joint United Nations Programme on HIV and AIDS (UNAIDS) welcomes this announcement to offer recombinant human insulin (rh-insulin) at US$ 0.10 per day (for the average 40 units of insulin that is required per patient per day) to low- and middle-income countries, a reduction of 50% from current prices. This announcement was made at an event hosted by UNAIDS to promote innovation in access to health care. “Price should not be reason to choose between life and death,” said Gunilla Carlsson, UNAIDS Executive Director, a.i. “AIDS activism has led the way in reducing the price of life-saving medicines and saving millions of lives. Today, we are glad that the universal health coverage movement is also benefitting from the lessons learned by the AIDS response.” More than 400 million people worldwide are affected by diabetes. Evidence shows that, as they live longer, many people living with HIV and on HIV treatment are increasingly susceptible to noncommunicable diseases. Several other companies made new commitments in support of increasing access to health care at an event organized by the UNAIDS Health Innovation Exchange on the topic of decentralization, innovation and sustainable financing, which was held in collaboration with the Center for Global Health and Development at the United Nations General Assembly in New York, United States of America. The Wadhwani Institute for Artificial Intelligence, an independent, non-profit research institute and global hub based in India, that is developing artificial intelligence solutions for social good, has committed to establishing a centre of excellence to leverage the use of artificial intelligence for global health. ThoughtFocus, a US based technology services company working on the internet of things (IoT), will provide access to its IoT platform, which is optimized to serve as an affordable, reliable and efficient platform to build and extend IoT solutions for transportation, logistics, manufacturing and utilities related to health-care services. The IoT has opened up a world of possibilities in health: when connected to the Internet, ordinary medical devices can collect invaluable additional data, give extra insight into symptoms and trends, enable remote care and generally give people more control over their lives and quality of treatment. Zenysis, another US based technology company, announced that it was investing US$ 3.5 million to implement data pilots in five countries over the coming three years that will help countries to make evidence-informed decisions in rolling out universal health coverage and prioritizing investments in health systems. “The private sector has a key role to play in advancing the Sustainable Development Goals,” said Ms Carlsson. “At UNAIDS, we believe that innovation and partnerships are the future to solving many of the basic development issues that confront us daily.” ]]> <![CDATA[Cipla launches Daptomycin for Injection]]> https://biospectrumindia.com/news/95/14776/cipla-launches-daptomycin-for-injection.html https://biospectrumindia.com/news/95/14776/cipla-launches-daptomycin-for-injection.html Thu, 26 Sep 2019 17:20:00 +0530 Cipla Limited and its subsidiary Cipla USA, Inc., (hereafter referred to as “Cipla”), The pharmaceuticals and drug company, announce the launch of Daptomycin for Injection, 500mg/vial, single-dose vial, AP-rated generic equivalent of Cubicin® for Injection in the United States.  According to IQVIA (IMS Health), Cubicin® for Injection (daptomycin for injection) had U.S. sales of approximately $606 Million for the 12-month period ending June 2019. The product is available for shipping immediately. ]]> <![CDATA[AstraZeneca receives DCGI approval for type 2 diabetes drug]]> https://biospectrumindia.com/news/95/14771/astrazeneca-receives-dcgi-approval-for-type-2-diabetes-drug.html https://biospectrumindia.com/news/95/14771/astrazeneca-receives-dcgi-approval-for-type-2-diabetes-drug.html Thu, 26 Sep 2019 11:55:00 +0530 AstraZeneca Pharma India Limited (AstraZeneca India) announced that it has received Import & Market permission for QTERN® (Fixed dose combination of Dapagliflozin 10mg + Saxagliptin 5mg) in India by the Drug Controller General of India (DCGI). This permission paves way for the launch of QTERN® in India, subject to the receipt of further related statutory approvals and licenses. QTERN® is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus (T2DM). QTERN® combines two anti-hyperglycaemic agents with complementary mechanisms of action in a once-daily tablet. The drug comprises sodium-glucose cotransporter 2 (SGLT2) inhibitor- dapagliflozin and a dipeptidyl peptidase-4 (DPP-4) inhibitor saxagliptin. SGLT-2 inhibitors help patients achieve improved glycaemic control by reducing the reabsorption of glucose from the blood and enabling its removal via the urine. SGLT-2 inhibitors, including Forxiga (dapagliflozin), have demonstrated reductions in HbA1c and have also been shown to reduce weight and blood pressure. DPP-4 inhibitors reduce blood glucose as measured by HbA1c. Type 2 diabetes in India is a disease of epidemic scale affecting over 63 million people. Rapid urbanization, industrialization and demographic transition resulting in altered lifestyles have been identified as the main causes for this alarming number. Significant unmet needs still exist, as many patients remain inadequately controlled on their current glucose-lowering regimen. QTERN® will provide yet another option to physicians to help them in managing type 2 diabetes of their patients. Gagandeep Singh Bedi, Managing Director, AstraZeneca India said, “Type-2 diabetes is a complex disease that is at epidemic proportions, affecting more than 63 million people in India. The approval of QTERN® is good news for patients who may benefit from improved glycaemic control by adding a DPP-4 inhibitor to a SGLT-2 inhibitor in a convenient once-daily tablet” ]]> <![CDATA[EISAI India collaborates with Mylan to commercialise Teceris]]> https://biospectrumindia.com/news/95/14768/eisai-india-collaborates-with-mylan-to-commercialise-teceris.html https://biospectrumindia.com/news/95/14768/eisai-india-collaborates-with-mylan-to-commercialise-teceris.html Wed, 25 Sep 2019 17:05:00 +0530 Eisai Pharmaceuticals and Mylan Pharmaceuticals have jointly announced that they have entered into a marketing license agreement to commercialize TECERIS®, the Innovator’s second brand of the anticancer agent Eribulin mesylate (eribulin) in India. TECERIS® will be manufactured and supplied by Eisai India and marketed by Mylan. This agreement is an important strategy for expanding the access of eribulin for the treatment of metastatic breast cancer (MBC) patients in India. Eribulin, a novel anticancer agent, discovered in-house by Eisai was approved in India in April 2013 for the treatment of locally advanced or metastatic breast cancer which previously was being treated with at least two chemotherapy regimens including an anthracycline and a taxane. In October 2013, Eisai India launched the eribulin brand Halaven® for eligible patients under its patient assistance programme. Commenting on the co-exclusive, marketing relationship, Dr. Sanjit Singh Lamba, Managing Director, Eisai India said, “Our endeavor at Eisai group always has been to ensure that we make our innovative products more accessible to patients who have an unmet medical need. We have been doing it through our tiered pricing programs and now we have entered into a partnership with Mylan to address unmet medical needs. This step is a part of our hhc philosophy of human health care thereby keeping the patient at the center and ensuring our medicines are accessible and affordable.” Commenting on the partnership, Rakesh Bamzai, President, India and Emerging Markets, Mylan said, “The launch of the innovator’s second brand of Eribulin, TECERIS® will enable enhanced access to the medicine through our co-exclusive marketing relationship as both Eisai India and Mylan share a commitment to bring affordable and high-quality medicines to market, especially in areas of unmet need. Eribulin is an important addition to our growing oncology portfolio and, expands the available treatment options for women with advanced or metastatic stages of breast cancer. The collaboration with Eisai India is yet another positive step in our ongoing efforts to help improve affordability and access to essential oncology treatments in India and serve the patient community.” The number of women diagnosed with breast cancer in India has increased in the recent years, with an estimated 163,000 new cases of breast cancer and approximately 87,000 related deaths in 2018. Breast cancer is now the most frequently diagnosed cancer in Indian women. The partnership between Eisai India and Mylan aims to enhance access and affordability of cancer treatment for breast cancer patients in India. Mylan’s oncology portfolio in India includes high quality, affordable cancer-related cytotoxic and targeted therapies for breast, lung and colorectal cancer.       ]]> <![CDATA[Transasia receives ZED Diamond Quality rating ]]> https://biospectrumindia.com/news/95/14762/transasia-receives-zed-diamond-quality-rating-.html https://biospectrumindia.com/news/95/14762/transasia-receives-zed-diamond-quality-rating-.html Wed, 25 Sep 2019 11:20:00 +0530 Transasia Bio-Medicals Ltd., India’s Leading IVD Company has announced that it has received the Diamond rating in ZED Quality Certification from the Ministry of MSME, Government of India and the Quality Council of India for its manufacturing facility at Mumbai (Seepz). The plant was assessed on 30 stringent parameters including manufacturing infrastructure, Lean concepts, 5S, Kaizen, daily management practices, manufacturing process and FMEA, impact of manufacturing on the environment. The entire assessment process is very elaborate and lasted a year. The ZED Quality Certification is an initiative by the Government to encourage ‘Make in India’ and export of Indian products, through manufacturing practices, aligned towards providing products aimed at Zero Defect (for customers) and Zero Effect (on the environment). First announced by Hon’ble Prime Minister Narendra Modi in 2014, the initiative is meant to raise quality levels in the MSME sector and is seen as the cornerstone of the Make in India programme. So far, 266 companies have been awarded in 23 manufacturing sectors. The extensive assessment process comprises self, desktop and site assessment and evaluates the companies on a total of 50 varied parameters. At the end of the assessment and evaluation, the final rating is provided to MSMEs based on the maturity assessment model (Bronze-Silver-Gold-Diamond-Platinum). Speaking on the achievement, Suresh Vazirani, Chairman & Managing Director said, “Transasia has been manufacturing in India from the early 1990s, much before the Make in India concept actually came into existence. Over the last forty years, our mission has always been to provide high quality diagnostic solutions that are reliable and environmentally sustainable. The quality of our products and solutions is recognized not only in India but in over 100 countries globally. As India’s No. 1 IVD Company, this recognition is an affirmation of the high quality of all our products.” “While we celebrate the fact that we are the first and only IVD Company in India to win this recognition, more importantly this milestone is a testimony that we employ GMP, Kaizen, Lean and other innovative processes to develop technologically advanced products that are also environmentally sustainable”, he further added. All of Transasia’s facilities have been awarded ISO 9001 and ISO 13485 since 1999 and 2008 respectively and all the products are European CE mark approved. In addition to it, some products as well as our Mumbai (Seepz) factory have been approved by US FDA. Infact, Transasia is the only Indian IVD Company to have US FDA approval. ]]> <![CDATA[Laurus Labs acquires subsidiary of Aspen Pharmacare ]]> https://biospectrumindia.com/news/95/14755/laurus-labs-acquires-subsidiary-of-aspen-pharmacare-.html https://biospectrumindia.com/news/95/14755/laurus-labs-acquires-subsidiary-of-aspen-pharmacare-.html Wed, 25 Sep 2019 10:00:00 +0530 Hyderabad based Laurus Labs Limited, a leading research and development driven pharmaceutical company, is pleased to announce that it has agreed to acquire 100% shares of Phekolong Pharmaceuticals Pty Ltd, a wholly owned subsidiary company of Pharmacare Ltd. t/a Aspen Pharmacare, South Africa, subject to completion of conditions precedent, by way of cash consideration of ZAR 75,000 (Seventy-five thousand South African Rands). The acquisition is expected to be completed by the end of November, 2019. At the conclusion of the transaction, all residual assets and liabilities that are within the target company immediately prior to completion will be for Pharmacare Limited's account and accordingly all such assets and liabilities will be transferred from the target company to Pharmacare Limited immediately prior to completion. ]]> <![CDATA[Engineers at Jaguar develop novel 3D printed gloves for workers]]> https://biospectrumindia.com/news/95/14754/engineers-at-jaguar-develop-novel-3d-printed-gloves-for-workers.html https://biospectrumindia.com/news/95/14754/engineers-at-jaguar-develop-novel-3d-printed-gloves-for-workers.html Tue, 24 Sep 2019 12:20:00 +0530 Engineers from Jaguar Land Rover are working on the next generation of protective workplace clothing – a lightweight 3D-printed glove which could help better protect employees from the threat of a musculoskeletal disorder. The 3D glove is designed for people working on the production line, for example those required to fit clips or fasteners into the chassis during assembly of Jaguar and Land Rover’s luxury vehicles. Musculoskeletal disorders, which include more than 100 different types of conditions, make up around 30% of all workplace injuries that result in time off* and account for a third of the money paid in compensation to employees. Musculoskeletal disorders affect an estimated 10% of the global population, rising to as much as 40% in certain industries**. Engineers at Jaguar Land Rover’s Gaydon site – home to one of the largest 3D printing facilities in the UK – saw an opportunity to use the company’s advanced manufacturing expertise to design and 3D print a lattice-style structure which would provide support to reduce muscle fatigue, but also be flexible and comfortable enough to wear during an eight-hour shift. Using 3D computer-aided design (CAD) software, the team modelled designs in different densities using a variety of materials for testing. Following feedback from trials, the team is now working on a second-generation prototype. It will include a foam pad made using impact additive D30 – a polymer material which absorbs impacts when placed under pressure. This will make the glove suitable for those who fit parts, such as door casings, using the palm of the hand. In the short term the gloves will support workers across Jaguar Land Rover’s facilities, helping to protect against musculoskeletal disorders. These form part of a wider future plan to deploy a range of technologies to assist those with muscle weakness or patients who suffer from physical or neurological disorders – helping employees return to work.  Chris Noble, Additive Manufacturing Strategic Engineer for Jaguar Land Rover, said: “The health and wellbeing of our workforce remains our priority across all factories and facilities. “Technologies like the 3D-printed glove allow us to use the world-leading expertise and equipment we have in-house to protect the hands of our makers, developing equipment that will make Jaguar Land Rover a great place to work, now and in the future.” The Jaguar Land Rover Additive Manufacturing Centre produces over 80 000 parts a year for a variety of applications, including functional prototyping, design mock-ups and manufacturing assembly aids and fixtures. Jaguar Land Rover is also able to 3D print parts for production cars with the Jaguar XE SV Project 8 one of the first vehicles to use them. The programme forms part of Jaguar Land Rover’s Destination Zero vision; an ambition to make societies safer and healthier, and the environment cleaner. Delivered through relentless innovation, the company’s focus is on achieving a future of zero emissions, zero accidents and zero congestion – across its facilities, and through its products and services. ]]> <![CDATA[Rybelsus by Novo Nordisk gets USFDA approval]]> https://biospectrumindia.com/news/95/14744/rybelsus-by-novo-nordisk-gets-usfda-approval.html https://biospectrumindia.com/news/95/14744/rybelsus-by-novo-nordisk-gets-usfda-approval.html Mon, 23 Sep 2019 14:15:00 +0530 Novo Nordisk has announced that the USFDA approval for Rybelsus® (semaglutide tablets), as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus. Rybelsus®, the brand name for oral semaglutide in the US, is the first approved glucagon-like peptide-1 (GLP-1) receptor agonist in a tablet. The approval of Rybelsus® is based on the results from 10 PIONEER clinical trials which included 9,543 adults with type 2 diabetes. Rybelsus® more effectively lowered blood sugar than sitagliptin and empagliflozin. Furthermore, treatment with Rybelsus® resulted in up to 4.4 kg reduction in body weight. Rybelsus® demonstrated a safe and well-tolerated profile across the PIONEER programme, with the most common adverse event being mild to moderate nausea which diminished over time. Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk said, “We are very excited that we can make the first oral GLP-1 available in the US and thereby expand the treatment options for adults living with type 2 diabetes. Novo Nordisk has a very long legacy of developing innovative injectable medicines for people living with diabetes and, with the approval of Rybelsus®, we are now able to bring our innovation into the market for oral antidiabetics.” Novo Nordisk plans to make Rybelsus® available to adults with type 2 diabetes in the US in the fourth quarter of 2019. ]]> <![CDATA[Dr. Reddy’s launches OTC Lansoprazole capsule in the U.S. market]]> https://biospectrumindia.com/news/95/14743/dr-reddys-launches-otc-lansoprazole-capsule-in-the-u-s-market.html https://biospectrumindia.com/news/95/14743/dr-reddys-launches-otc-lansoprazole-capsule-in-the-u-s-market.html Mon, 23 Sep 2019 14:05:00 +0530 Dr. Reddy’s Laboratories Ltd. has announced the launch of Lansoprazole Delayed-Release Capsules USP, 15 mg, an over-the-counter (OTC) store-brand equivalent of Prevacid® 24HR Capsules, in the United States market, as approved by the U.S. Food and Drug Administration (USFDA). Dr. Reddy’s OTC Lansoprazole Delayed-Release Capsules USP, 15 mg, is an over-the-counter, Proton Pump Inhibitor (PPI) used to treat frequent heartburn occurring two or more days a week. "We are pleased to continue to expand our antacids and PPI portfolio for our customers,” says Milan Kalawadia, Senior Vice President and Head of US OTC and Specialty Rx Divisions, Dr. Reddy’s Laboratories. “We look forward to collaborating with our customers to provide high-quality, affordable alternatives to consumers.” The Prevacid® 24HR brand and generic had U.S. sales of approximately $57 million MAT for the most recent twelve months ending in August 2019 according to IRi. Dr. Reddy’s OTC Lansoprazole Delayed-Release Capsules USP, 15 mg, are available in 14, 28 and 42 count sizes. Prevacid® is a registered trademark of Takeda Pharmaceuticals North America, Inc. ]]> <![CDATA[Eisai Pharma and Mylan collaborate to promote, distribute eribulin]]> https://biospectrumindia.com/news/95/14740/eisai-pharma-and-mylan-collaborate-to-promote-distribute-eribulin.html https://biospectrumindia.com/news/95/14740/eisai-pharma-and-mylan-collaborate-to-promote-distribute-eribulin.html Mon, 23 Sep 2019 12:10:00 +0530 Eisai Co., Ltd. based in Tokyo, announced that Eisais subsidiary Eisai Pharmaceuticals India Pvt. Ltd. (Location: Andhra Pradesh,Eisai India) and Mylan N. V. (Headquarters: Pennsylvania, United States) subsidiary Mylan India have entered into a license agreement to promote and distribute the second brand TECERIS® for the anticancer agent eribulin mesylate (eribulin) in India.  Under this agreement, eribulin will be supplied to Mylan India by Eisai India as well as promoted and distributed by Mylan India as TECERIS. Mylan India has a wide portfolio of medicines in oncology and brand building ability in India. Eisai group positions this agreement as an important strategy for expanding access to eribulin following the tiered-pricing model* in which the cost burden to patients is differentiated according to income level. Further availability of eribulin to patients all over India is expected by supplying eribulin in two brands, two channels: Halaven® by Eisai India and TECERIS by Mylan India.  Eribulin is a novel anticancer agent discovered in-house by Eisai. In India, Eisai is steadily expanding the availability of eribulin to patients since Eisai India has launched eribulin as Halaven and introduced a tiered-pricing model in October 2013. Eribulin’s indication for breast cancer in India is the locally advanced or metastatic breast cancer who have progressed after at least one chemotherapeutic regimen for advanced disease. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting unless patients were not suitable for these treatments.  Eisai group positions oncology as a key therapeutic area, and is aiming to discover revolutionary new medicines with the potential to cure cancer. In addition, Eisai group will continue to adopt proactive measures aimed at increasing access to its innovative pharmaceutical products in emerging countries and the developing world in order to contribute to an increase in the benefits provided to local patients and their families. ]]> <![CDATA[Lupin receives sANDA approval for Levothyroxine Sodium Tablets ]]> https://biospectrumindia.com/news/95/14727/lupin-receives-sanda-approval-for-levothyroxine-sodium-tablets-.html https://biospectrumindia.com/news/95/14727/lupin-receives-sanda-approval-for-levothyroxine-sodium-tablets-.html Fri, 20 Sep 2019 15:25:00 +0530 Lupin has announced that it has received approval for its sANDA for Levothyroxine Sodium Tablets USP, 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg, 200 mcg, and 300 mcg, from the United States Food and Drug Administration (U.S. FDA), to market a generic equivalent of UNITHROID® 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg, 200 mcg, and 300 mcg, manufactured by Jerome Stevens Pharmaceuticals Inc. Lupin’s Levothyroxine Sodium Tablets USP, 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg, 200 mcg, and 300 mcg was originally approved on January 18, 2019 as generic equivalent of SYNTHROID® 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg, 200 mcg, and 300 mcg, manufactured by ABBVIE Inc. With this sANDA approval, Lupin’s Levothyroxine Sodium Tablets USP, 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg, 200 mcg, and 300 mcg are now AB rated (therapeutically equivalent) with Reference Listed Drugs, SYNTHROID® and UNITHROID®. Lupin’s Levothyroxine Sodium Tablets are indicated for: Hypothyroidism: As replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression: As an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer Levothyroxine Sodium Tablets USP (RLD: UNITHROID® and SYNTHROID®) had annual sales of approximately USD 2581 million in the US (IQVIA MAT June 2019). ]]> <![CDATA[ACG selects Salesforce to empower customer relationships]]> https://biospectrumindia.com/news/95/14718/acg-selects-salesforce-to-empower-customer-relationships.html https://biospectrumindia.com/news/95/14718/acg-selects-salesforce-to-empower-customer-relationships.html Fri, 20 Sep 2019 10:00:00 +0530 ACG group, an integrated pharma manufacturing solutions company, has announced that it has chosen Salesforce, the global leader in CRM, to accelerate its digital transformation journey, strengthen customer relationships and foster its global expansion. As a fully-integrated machinery and materials supplier, ACG is the preferred partner for pharmaceutical businesses across the globe. The company aims to further strengthen this position through extensive R&D investments and strategic alliances, making ACG the 'first choice' supplier for the global pharmaceutical industry. ACG is deploying Salesforce Sales Cloud to modernize its sales processes and better integrate customer data, providing sales teams with access to rich insights into customer needs and preferences. The solution will provide a single, 360-degree view of each customer that will enable ACG to strengthen its customer relationships and deliver more personalized customer experiences. In addition, deeper business intelligence will help the team to make data-driven decisions, setting ACG up for increased customer success and growth.   Peter Neve, CMO at ACG, said, “For over five decades, we have been empowering businesses with integrated solutions across the world. Our partnership with Salesforce will help us drive holistic growth by increasing overall business efficiency and providing stellar customer experiences. We look forward to taking our business to the next level with Salesforce and becoming the preferred partners for pharmaceutical businesses across the globe.” Sunil Jose, SVP and Country Leader, Salesforce India, said "Technological innovations have changed the face of modern customer engagement. Companies are being challenged to rethink how they engage with increasingly connected, empowered, and discerning customers. We are proud to be a technology partner for ACG Group in helping them supercharge growth and surpass customer expectations.”   ]]> <![CDATA[AstraZeneca strengthens partnership with NASSCOM to fight NCDs]]> https://biospectrumindia.com/news/95/14716/astrazeneca-strengthens-partnership-with-nasscom-to-fight-ncds.html https://biospectrumindia.com/news/95/14716/astrazeneca-strengthens-partnership-with-nasscom-to-fight-ncds.html Fri, 20 Sep 2019 09:00:00 +0530 A day-long flagship health-tech event of NASSCOM, LHIF “Re-defining the Healthcare Landscape - The Digital Shift”, was inaugurated on 19th Sept by some of the leading names in the industry.  LHIF (Lifesciences & Healthcare Innovation Forum) is a platform created by NASSCOM to drive digital transformation in the Lifesciences and Healthcare Industry. This Forum is one of the largest neutral eco-systems comprising stakeholders from Pharmaceutical Industry, Med-Tech Companies, Health Insurance organizations, Hospitals, Radiology and Imaging companies, Technology Companies, Industry Associations, Startups, Academia and government bodies. Nearly 300+ participants from across the life sciences & healthcare supply chain attended from all over India.  Keynotes were given by Dr. Devi Shetty, Chairman & Executive Director, Narayana Health, Mr. Nalinikanth Gollagunta, Managing Director, Wipro GE Healthcare, Mr. Niclas Jacobson, Deputy Director - Ministry of Health and Social Affairs, Govt. of Sweden and Mr. Gagan Singh, Managing Director, AstraZeneca Pharma India Ltd. The event discussed a wide range of topics in healthcare such as Med-Tech Innovation in Healthcare, The Digital Doctor Of The Future, Societal Impact Through Health-Tech, Cloud Computing In Healthcare & Lifesciences, Building a Unified Digital Health Platform and Current Trends in Healthcare.  Sankara Nethralaya Medical Research Foundation presented a collection of industry success stories in digital adoption. In addition, the #LHIF Startup Awards were presented to SIX high-impact and tech-driven healthcare startups breaking new ground in innovation & healthcare. Speaking on the occasion, Debjani Ghosh, President, NASSCOM states, “Advanced technology adoption in Indian healthcare sector is poised for substantial growth as it continues to emerge as a game-changer in the delivery of quality healthcare services. Technological innovations and interventions are crucial to convert today’s expensive medical discoveries into affordable solutions. The NASSCOM LHIF is an important step in developing a closer partnership between health-tech companies, global healthcare organisations, academia and the government to work collaboratively in deploying proven innovation to solve critical healthcare challenges present today and at pace to enable the local population to get the best and most efficient healthcare services possible. NASSCOM’s collaboration with AstraZeneca is one such effort in this area to further promote digitally-enabled technologies, across regions, so that evidence can be generated, and tech adoption is scaled at speed, both domestically and internationally.” Delivering the opening Keynote address at the forum, Gagan Singh, Managing Director, AstraZeneca Pharma India Limited shared that both NASSCOM and AstraZeneca are committed to strengthening their collaboration towards driving the digital healthcare agenda. This partnership would focus on healthcare delivery interventions via digital technologies and collaboration towards Healthcare Innovation Centers showcasing the impact of such solutions across the patient journey, from early diagnosis, to treatment and wellness. NASSCOM & AstraZeneca’s have an existing partnership under the iDREAM programme – a health tech start-up accelerator programme and incubation centre in Bengaluru that supports start-ups in bringing innovative and frugal solutions that can help in the management of NCDs in India and beyond.   AstraZeneca’s iDREAM platform is a global initiative that seeks to create innovative solutions for improving patient’s lives through partnerships with start-ups, companies and academia to develop patient-centric solutions. ]]> <![CDATA[Novartis announces positive results from VERIFY study in type 2 diabetes]]> https://biospectrumindia.com/news/95/14710/novartis-announces-positive-results-from-verify-study-in-type-2-diabetes.html https://biospectrumindia.com/news/95/14710/novartis-announces-positive-results-from-verify-study-in-type-2-diabetes.html Thu, 19 Sep 2019 13:40:00 +0530 Early combination treatment strategy with vildagliptin and metformin was superior to standard of care in newly diagnosed type 2 diabetes patients Novartis has announced the key results from the Phase IV clinical study VERIFY evaluating the long-term efficacy and safety of early combination treatment strategy with metformin plus vildagliptin (dipeptidyl peptidase-4 [DPP-4] inhibitor) compared to the traditional stepwise approach with metformin as initial therapy followed by vildagliptin, added at the time of metformin failure. The key study findings were presented today at the European Association for the Study of Diabetes (EASD) Annual Meeting and published simultaneously in The Lancet. VERIFY is a unique study designed to determine durability, over a pre-specified five-year follow-up of early use of combination therapy strategy with vildagliptin-metformin. The study was conducted across 254 centers in 34 countries and involved 2001 treatment-naïve diverse individuals recently diagnosed with T2DM (HbA1c between 6.5–7.5% [48–58 mmol/mol]). Professor David Matthews, EASD President and Emeritus Professor of Diabetic Medicine, University of Oxford, UK said, “The initial findings from the VERIFY study uniquely demonstrate that early intervention with a combination therapy strategy provides greater and durable long-term benefits for patients. The currently recommended initial monotherapy approach with later treatment intensification in type 2 diabetes management is now shown to be an inferior strategy.” The overall safety and tolerability profile was similar between the treatment approaches, with no unexpected or new safety findings reported. Sanjay Murdeshwar, Managing Director, Novartis in India said, “In light of the existing gaps in diabetes management in India which is home to over 72 million people living with diabetes, we continue to focus on driving science in order to improve patient outcomes. The VERIFY study is an extension of our efforts towards continuing to win for as many patients with diabetes. The positive results from the VERIFY study further affirm the importance of early treatment intensification in newly diagnosed type 2 diabetes patients.” Additional pre-defined secondary analyses of the VERIFY study results are ongoing and data will be disclosed over the coming months at international and local medical congresses and in scientific journals.   ]]> <![CDATA[AskBio acquires assets from RoverMed BioSciences]]> https://biospectrumindia.com/news/95/14704/askbio-acquires-assets-from-rovermed-biosciences.html https://biospectrumindia.com/news/95/14704/askbio-acquires-assets-from-rovermed-biosciences.html Wed, 18 Sep 2019 14:30:00 +0530 Asklepios BioPharmaceutical (AskBio), a fully integrated Adeno-Associated Virus (AAV) gene therapy platform company focused on providing curative therapeutics for genetic disorders, has acquired the technology assets of RoverMed BioSciences. RoverMed developed nanotechnology cargo delivery of therapeutics into the nucleus of diseased cells without affecting healthy cells. Under the terms of the agreement, AskBio will integrate the company's technology and assume all assets of RoverMed.  Consistent with AskBio's focus on meeting the challenges of gene therapy head-on, RoverMed's nanocapsule technology carries large or small molecules, naked DNA and/or viral particles across biological barriers and into the nuclei of the targeted cells, no matter where they are located in the body. This non-viral nanotechnology can potentially achieve unequalled delivery efficiency and precision targeting, as well as repeat administration to reach and treat diseases from inside the cell. "The addition of RoverMed technology provides us with another means for delivering therapeutic molecules, including large or small molecules, to increase stability and specificity and could enable entire new tissues and diseases to be reachable," said Sheila Mikhail, CEO of AskBio. "We continue to explore new technologies and expand therapeutic innovation to ensure that effective gene therapies for genetic disorders can be accessible to patients in need across the globe without limits." AskBio's integrated gene therapy platform includes an expansive capsid library, scaled Pro10™ manufacturing and new delivery methods to accelerate and lower the cost of end-to-end gene therapy processes and support its portfolio of curative therapeutics. ]]> <![CDATA[Glenmark receives ODD for Multiple Myeloma drug]]> https://biospectrumindia.com/news/95/14687/glenmark-receives-odd-for-multiple-myeloma-drug.html https://biospectrumindia.com/news/95/14687/glenmark-receives-odd-for-multiple-myeloma-drug.html Tue, 17 Sep 2019 14:50:00 +0530 Glenmark Pharmaceuticals has announced that the USFDA has granted Orphan Drug Designation to its bispecific antibody candidate GBR 1342 for the treatment of patients with multiple myeloma who have received prior therapies. Derived from the company’s proprietary BEAT® (Bispecific Engagement by Antibodies based on the T cell receptor) technology, GBR 1342 is being investigated for the treatment of multiple myeloma. The candidate is one of five clinical-stage assets in the pipeline of Glenmark’s new innovation company. GBR 1342 is designed to bind to both CD3 on T cells and CD38, an antigen known to be implicated in hematological malignancies, on target cells. This activates T cells and redirects them toward CD38+ tumor cells found in multiple myeloma. Once directed at the right target, the T cells help destroy the tumor cells. A first-in-human, open-label, Phase 1 trial of GBR 1342 in multiple myeloma, is ongoing to assess the safety and tolerability of increasing doses of GBR 1342, and will also evaluate biomarkers, immunogenicity, and additional measures of disease activity. Alessandro Riva, MD, CEO of the new company said, “Patients who are struggling with diseases like multiple myeloma are seeking new treatment options and innovative approaches. We believe the focus of our new company is essential to these patients and to the healthcare system. As one of our first important pipeline milestones, we are excited that the FDA has recognized the potential for GBR 1342 to offer a significant advancement for patients with multiple myeloma.” Multiple myeloma is a rare blood disorder in which plasma cells in the bone marrow become malignant and replicate unchecked. The malignant plasma cells can displace normal blood cells in the body, leading to anemia and uncontrolled bleeding. It can also cause issues with bone density and strength, as well as lead to an increased risk of infection by lowering the body’s immune response. More than 32,000 new cases of multiple myeloma are expected to be diagnosed in 2019 in the U.S.2 During that same time, about 13,000 people are expected to die from the disease. The FDA Office of Orphan Products Development grants orphan drug designation to novel drugs and biologics that are intended for the safe and effective treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the United States. ]]> <![CDATA[Ambit Bio Medix opens cardio diabetic care division]]> https://biospectrumindia.com/news/95/14684/ambit-bio-medix-opens-cardio-diabetic-care-division.html https://biospectrumindia.com/news/95/14684/ambit-bio-medix-opens-cardio-diabetic-care-division.html Tue, 17 Sep 2019 14:40:00 +0530 Gujarat based Ambit Bio Medix, which is a leading PCD Pharma Franchise Company in India, has announced the implementation of their exclusive cardio diabetic division of care. The elite division of care by Ambit is a dedicated entity which will support the enablement of quality pharmaceutical products for franchise models as well as distributorships. Ambit Bio Medix has achieved several critical milestones. And with this franchise model, the company wants to spread out its business network with premium quality cardio diabetic Pharma franchise programs. With this program, they have come forward with a unique PCD pharma franchise business model for medical representatives and stakeholders at national horizons. ]]> <![CDATA[Lupin receives Health Canada approval for Propranolol Hydrochloride ER Capsules]]> https://biospectrumindia.com/news/95/14673/lupin-receives-health-canada-approval-for-propranolol-hydrochloride-er-capsules.html https://biospectrumindia.com/news/95/14673/lupin-receives-health-canada-approval-for-propranolol-hydrochloride-er-capsules.html Mon, 16 Sep 2019 11:40:00 +0530 Pharma major Lupin Limited (Lupin) announced that it has received approval for its Propranolol Hydrochloride Extended-Release (ER) Capsules, 60 mg, 80 mg, 120 mg and 160 mg from Health Canada. Lupin is the first generic company to receive an approval for generic Inderal®-LA Capsules for the Canadian market and the product has been approved and will be manufactured from Lupin’s Pithampur Unit-2 Facility. Lupin’s Propranolol Hydrochloride Extended-Release (ER) Capsules, 60 mg, 80 mg, 120 mg and 160 mg, are the generic version of Inderal®-LA Capsules, 60 mg, 80 mg, 120 mg and 160 mg of Pfizer Canada ULC, and are indicated in the treatment of hypertension and for the prophylaxis of angina pectoris. Propranolol Hydrochloride Extended-Release (ER) Capsules (Canadian Reference Product: Inderal®-LA Capsules) had an annual sales of approximately CAD 8.6 million. ]]> <![CDATA[Biocon to enter Greater China market]]> https://biospectrumindia.com/news/95/14665/biocon-to-enter-greater-china-market.html https://biospectrumindia.com/news/95/14665/biocon-to-enter-greater-china-market.html Thu, 12 Sep 2019 19:30:00 +0530 Biocon Ltd, Asia’s premier biopharmaceuticals company, has announced that it has signed a License and Supply Agreement with a subsidiary of China Medical System Holdings Ltd. (CMS) for three Generic Formulation products in Greater China. This development is in line with Biocon’s long term generic formulations strategy and expands our Generic Formulations business footprint to the Chinese pharmaceuticals market, which is the second largest pharmaceutical market in the world. Under the terms of the agreement, Biocon will be responsible for the development, manufacturing and supply of the products. CMS will be responsible for registration and commercialization of the products in China. The total addressable market size for these three products in Mainland China is about US$ 0.8 billion, as per recent IQVIA data. The initial term of the agreement shall be for 10 years from the date of commercialization, extendable by two years on a product basis by mutual consent. This collaboration can be extended to a broader portfolio in future. Dr Arun Chandavarkar, CEO and Joint Managing Director, Biocon, said: “We are excited to partner with CMS, which is  a leading Chinese pharma company in the Greater China region. This collaboration will allow us to take our US approved Generic Formulations to patients in China, allowing us an early entry in the world's second largest, and rapidly-growing generics market.” China's National Medical Products Administration (NMPA) has recently introduced the Quality Consistency Evaluation (QCE) system, which aims to ensure that all generic medicines marketed or manufactured in China meet internationally recognized quality standards. The QCE regulations are part of a wide-ranging package of healthcare system reforms introduced by the Chinese government over the past few years to accelerate generic penetration. Biocon's Generic Formulations business is built on the back of Company’s strong portfolio of complex and differentiated APIs. Through forward integration into dosage forms, the Company seeks to provide a safe, efficacious and continuous supply of high quality affordable drugs to address patient needs in diverse markets. We have commenced multiple programs to build a robust pipeline of technology-intensive molecules for global markets. Biocon has successfully commercialized a few products under its own label in the US. ]]> <![CDATA[Dr. Reddy's announces the launch of Fosaprepitant for Injection in US market]]> https://biospectrumindia.com/news/95/14664/dr-reddys-announces-the-launch-of-fosaprepitant-for-injection-in-us-market.html https://biospectrumindia.com/news/95/14664/dr-reddys-announces-the-launch-of-fosaprepitant-for-injection-in-us-market.html Thu, 12 Sep 2019 17:40:00 +0530 Dr. Reddy’s Laboratories has announced the launch of Fosaprepitant for Injection, the therapeutic generic equivalent of EMEND® (fosaprepitant) for injection, approved by the USFDA. Marc Kikuchi, Chief Executive Officer, North America Generics, Dr. Reddy’s Laboratories said, “We are pleased to be among the first generics to launch this product. This is a great addition to our injectable portfolio in the U.S. market as we continue to augment our product offering and drive growth for the hospital segment.” The EMEND® for Injection brand had an U.S. sales of approximately $279 million MAT for the most recent twelve months ending in July 2019 according to IQVIA Health. Dr. Reddy’s Fosaprepitant for Injection is available in 150 mg single-dose vial for reconstitution.   ]]> <![CDATA[IIL hosts Cabinet Minister Giriraj Singh]]> https://biospectrumindia.com/news/95/14653/iil-hosts-cabinet-minister-giriraj-singh.html https://biospectrumindia.com/news/95/14653/iil-hosts-cabinet-minister-giriraj-singh.html Wed, 11 Sep 2019 14:45:00 +0530 Indian Immunologicals Limited (IIL), a leading biologicals company in India, hosted Giriraj Singh, Cabinet Minister for Animal Husbandry, Dairying and Fisheries, Government of India at its Gachibowli plant in Hyderabad. The Minister visited the company and was given a presentation taking him through the various initiatives of the company in manufacturing quality vaccines at affordable prices to ensure better animal health and human health. The Minister accompanied by a delegation of high officials took a tour of the state-of-the-art automated FMD vaccine manufacturing facility of Indian Immunologicals. The minister was highly impressed with the infrastructure at the facility. On the visit of the Central Minister, Dr. K. Anand Kumar, Managing Director - Indian Immunologicals said, “Since its inception in 1982, IIL has been working towards producing quality vaccines at affordable costs. We are delighted and highly motivated to have the honorable Minister Mr. Giriraj Singh visiting us. We will take all possible steps as desired by the Minister and assist the Government in working towards eradication of FMD and Brucellosis diseases.” IIL has 4 manufacturing facilities at various locations – Karkapatla, Telangana – Human Vaccines & Animal Health Formulations; Ooty, Tamil Nadu – Anti Rabies production unit; Hyderabad, Telangana – Human Biologicals Unit (Gachibowli) and animal vaccines unit; Dargaville, New Zealand - Bovine Serum. IIL exports various Human and animal vaccines to over 50 countries and currently employs around 1,300 people. ]]> <![CDATA[Sanofi India to sell Ankleshwar site to Zentiva]]> https://biospectrumindia.com/news/95/14652/sanofi-india-to-sell-ankleshwar-site-to-zentiva.html https://biospectrumindia.com/news/95/14652/sanofi-india-to-sell-ankleshwar-site-to-zentiva.html Wed, 11 Sep 2019 13:40:00 +0530 The Board of Directors of Sanofi India Limited (SIL) has approved a transaction for the slump sale and transfer of its manufacturing facility at Ankleshwar, Gujarat to Zentiva and its legal entity in India, Zentiva Private Limited for a consideration of Rs. 2,617 million, subject to customary working capital adjustments.  This transaction is subject to shareholders’ approval and the completion of certain conditions as defined under the Business Transfer Agreement. In 2018, as part of a global transaction, Zentiva, which was Sanofi’s European generics business, was sold to Advent International. “Sanofi’s long-term strategy is to focus on manufacturing Sanofi branded products. Given that the two companies share similar values and commitment towards serving patients and their employees, the Board of Directors of Sanofi India Limited approved this transaction in the long-term interest of all stakeholders.” said Rajaram NARAYANAN, Managing Director – Sanofi India Limited.  The Ankleshwar site is Sanofi India’s oldest manufacturing facility where brands like Combiflam®, Allegra® and Amaryl® are made. The production of these iconic brands will now be moved to the Company’s Goa site and external manufacturing sites as well. About the Ankleshwar site: Established in 1987, the site has a chemistry & biotechnology development centre, and manufactures both intermediates and pharmaceutical formulations. A large producer of tablets, Sanofi’s Ankleshwar site manufactures more than 6 billion tablets annually. ]]> <![CDATA[LifeSan Clinical Research receives zero 483 observations from USFDA inspections]]> https://biospectrumindia.com/news/95/14649/lifesan-clinical-research-receives-zero-483-observations-from-usfda-inspections.html https://biospectrumindia.com/news/95/14649/lifesan-clinical-research-receives-zero-483-observations-from-usfda-inspections.html Wed, 11 Sep 2019 11:00:00 +0530 LifeSan Clinical Research, the clinical research division of Centaur Pharmaceuticals was audited by the USFDA and was concluded with zero 483 observations which signifies compliance and conformance to applicable GCP regulations.  LifeSan has successfully faced 6 inspections from USFDA; 2 inspections from MHRA/ EMA and 1 inspection from MCC, South Africa, in its twelve years of existence. It undertakes bioavailability/ bioequivalence studies, which are mandatory for generic drug approval process and phase II/III clinical trials. Since inception, LifeSan has submitted many studies to regulatory agencies of USFDA, EMA, MCC South Africa and TGA, Australia as well as CDSCO, the Indian Drug Regulatory Authority, including successful conduct of phase II and III clinical trial of a new chemical entity [NCE]. S.D Sawant, Managing Director, Centaur Pharmaceuticals said, “The zero 483 observations to our clinical research division, LifeSan Clinical Research is yet another feather in our cap. We are happy with this significant development not only for Centaur but also for the Indian pharmaceutical industry. In addition to USFDA accreditation, the said facility also conforms to MHRA (UK), TGA (Australia), Health Canada, MCC (South Africa) and WHO-GMP standards.” Earlier in May 2019, Centaur Pharmaceuticals oral solid dosage facility in Pune had received no action indicated (NAI) compliance status with zero 483 observations from the USFDA. In addition to USFDA accreditation, the Pune facility also conforms to MHRA (UK), TGA (Australia), Health Canada, MCC (South Africa) and WHO-GMP standards.    ]]> <![CDATA[Glenmark receives ANDA approval for Clobetasol Propionate Foam, 0.05% ]]> https://biospectrumindia.com/news/95/14644/glenmark-receives-anda-approval-for-clobetasol-propionate-foam-0-05-.html https://biospectrumindia.com/news/95/14644/glenmark-receives-anda-approval-for-clobetasol-propionate-foam-0-05-.html Tue, 10 Sep 2019 16:20:00 +0530 Glenmark Pharmaceuticals has been granted final approval by the United States Food & Drug Administration for Clobetasol Propionate Foam, 0.05% (Emulsion Formulation), a generic version of Olux®-E Foam, 0.05%, of Mylan Pharmaceuticals Inc According to IQVIATM sales data for the 12 month period ending July 2019, the Olux®-E Foam, 0.05% market2 achieved annual sales of approximately $11.1 million. Glenmark’s current portfolio consists of 161 products authorized for distribution in the U.S. marketplace and 54 ANDA’s pending approval with the USFDA. ]]> <![CDATA[Lupin receives USFDA approval for Fosaprepitant for Injection]]> https://biospectrumindia.com/news/95/14623/lupin-receives-usfda-approval-for-fosaprepitant-for-injection.html https://biospectrumindia.com/news/95/14623/lupin-receives-usfda-approval-for-fosaprepitant-for-injection.html Fri, 06 Sep 2019 15:15:00 +0530 Lupin has announced that it has received approval for its Fosaprepitant for Injection, 150 mg Single-Dose Vial, from the United States Food and Drug Administration. Lupin’s Fosaprepitant for Injection, 150 mg Single-Dose Vial, is the generic version of Emend® for Injection, 150 mg Single-Dose Vial, of Merck Sharp & Dohme Corp. (Merck). It is indicated for adults in combination with other antiemetic agents, for the prevention of: Acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin. Delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC). Fosaprepitant for Injection, 150 mg Single-Dose Vial, had annual sales of approximately USD 285 million in the US (IQVIA MAT June 2019). ]]> <![CDATA[Alkem Labs receives USFDA’s Form 483 with 2 observations]]> https://biospectrumindia.com/news/95/14620/alkem-labs-receives-usfdas-form-483-with-2-observations.html https://biospectrumindia.com/news/95/14620/alkem-labs-receives-usfdas-form-483-with-2-observations.html Fri, 06 Sep 2019 12:55:00 +0530 Alkem Laboratories has announced that the US FDA had conducted an inspection at the Company's manufacturing facility located at Daman, India from 26th August, 2019 to 30th August, 2019. At the end of the inspection, the Company has received a Form 483 with two (2) observations. The Company shall put together a detailed response with adequate corrective and preventive measures to address the US FDA observations and the same is proposed to be filed within the timeline stipulated by US FDA. ]]> <![CDATA[EC approves Merck’s KEYTRUDA in combination with Inlyta to treat RCC]]> https://biospectrumindia.com/news/95/14616/ec-approves-mercks-keytruda-in-combination-with-inlyta-to-treat-rcc.html https://biospectrumindia.com/news/95/14616/ec-approves-mercks-keytruda-in-combination-with-inlyta-to-treat-rcc.html Thu, 05 Sep 2019 15:20:00 +0530 Merck , known as MSD outside the United States and Canada,has announced that the European Commission has approved KEYTRUDA, Merck’s anti-PD-1 therapy, in combination with Inlyta (axitinib), a tyrosine kinase inhibitor, for the first-line treatment of patients with advanced renal cell carcinoma (RCC). This approval includes patients in all IMDC risk groups. It is based on findings from the pivotal Phase 3 KEYNOTE-426 trial, which demonstrated that KEYTRUDA in combination with axitinib reduced the risk of death by 47% compared with sunitinib (HR=0.53 [95% CI, 0.38, 0.74]; p=0.00005) in patients with advanced RCC. The KEYTRUDA with axitinib combination also demonstrated an improvement in progression-free survival (PFS) and objective response rate (ORR) compared with sunitinib. “Advanced renal cell carcinoma is one of the most lethal types of cancer, with the majority of patients dying within five years of their initial diagnosis,” said Prof. Thomas Powles, lead investigator for KEYNOTE-426 and director of Barts Cancer Centre. “It’s encouraging that we can now offer patients in Europe the KEYTRUDA with axitinib combination as a first-line treatment option.” The approval allows marketing of the KEYTRUDA combination in all 28 EU member states plus Iceland, Lichtenstein and Norway. “The European approval of the KEYTRUDA with axitinib combination for the treatment of advanced RCC marks an important milestone in our efforts for patients with this aggressive disease,” said Dr. Scot Ebbinghaus, vice president, clinical research, Merck Research Laboratories. “Offering an additional treatment option in the first-line setting is particularly important in patients with advanced RCC and underscores our commitment to develop KEYTRUDA in areas of unmet need.” ]]> <![CDATA[Cadila Pharma creates awareness on depression]]> https://biospectrumindia.com/news/95/14608/cadila-pharma-creates-awareness-on-depression.html https://biospectrumindia.com/news/95/14608/cadila-pharma-creates-awareness-on-depression.html Thu, 05 Sep 2019 11:55:00 +0530 Cadila Pharmaceuticals under its Cure with Compassion program   conducted a social media campaign recently for creating awareness regarding Depression, a disease identified by the World Health Organization (WHO) as a major health hazard. According to WHO, an estimated 300 million people in the world suffer from depression.  In India, 6.5 crore people, or roughly 8 crore people, suffer from some form of serious mental disorder. Unfortunately, while other chronic diseases such as heart disease or diabetes aren’t looked down upon or stigmatized, depression is highly stigmatized in our society. Sensing the need of the hour, Cadila Pharmaceuticals roped in leading psychiatrists from Gujarat and Uttar Pradesh, and ran a social media awareness campaign from August 21 to 23 on depression. The experts said that people with depression normally suffer from loss of energy, loss of appetite, change in sleeping pattern, anxiety, restlessness, guilt, reduced concentration, etc. Even suicidal thoughts are seen in many patients. They also spoke about various causes of depression, and appealed to the citizens to not ignore mental disorders. In his message, Dr. Vishal Damani from Ahmedabad, said, “WHO has classified Depression as the fourth most dangerous disease. Depression is a common mental order, characterized by persistent sadness and loss of interest in activities that one normally enjoys.” Dr. Samyak Tiwari from Lucknow said, “Depression is widespread and can affect anyone – be it a child or the elderly. The chances of women suffering from depression are greater than men.” Dr. Bhavesh Kotak from Rajkot said that depression can be genetic, and can also be caused by a variety of other factors. Dr. Kritugnasinh Vaghela from Vadodara, Dr Anoop Srivastava from Gorakhpur and Dr. Pranav Pacchighar from Surat also shared valuable insights in their videos. The campaign was a success with people getting sensitized to the mental disorders. ]]> <![CDATA[Lupin collaborates with Boehringer Ingelheim for novel oncology drug ]]> https://biospectrumindia.com/news/95/14597/lupin-collaborates-with-boehringer-ingelheim-for-novel-oncology-drug-.html https://biospectrumindia.com/news/95/14597/lupin-collaborates-with-boehringer-ingelheim-for-novel-oncology-drug-.html Wed, 04 Sep 2019 12:40:00 +0530 Boehringer Ingelheim and Lupin Limited have announced a licensing, development and commercialization agreement for Lupin’s MEK inhibitor compound (LNP3794) as a potential targeted therapy for patients with difficult-to-treat cancers. The partnership aims to develop Lupin’s lead MEK inhibitor compound in combination with one of Boehringer Ingelheim’s innovative KRAS inhibitors for patients with gastrointestinal and lung cancers harboring a broad range of oncogenic KRAS mutations. Commenting on the partnership, Nilesh Gupta, Managing Director, Lupin Limited said, “With the success of our second new drug discovery program in oncology, we have made a significant mark in bringing novel treatments to patients. Lupin’s MEK Inhibitor program successfully cleared early clinical stages, demonstrating our capabilities in delivering world class innovation. We are proud of the achievements of our team and the capabilities we have built which enable us to further our new drug discovery program. We are delighted to partner with Boehringer Ingelheim in developing treatments that will truly benefit patients in need.” Dr. Raj Kamboj, President of Lupin’s Novel Drug Discovery and Development (NDDD) stated, “The success of our second NDDD program in Oncology has added to our confidence in bringing highly differentiated and best-in-class innovation from India for patients globally. Carrying forward our founder, Dr. Desh Bandhu Gupta’s dream in shaping true innovation, we have delivered a novel treatment from conceptualization to clinical stage development with promising results that can be a potential combination treatment for precision oncology.” Norbert Kraut, Ph.D., Head of Global Cancer Research at Boehringer Ingelheim said, “The licensing of Lupin’s novel MEK inhibitor enables us to pair with our innovative KRAS inhibitors to develop new combination treatment concepts providing more effective and durable responses for patients with cancers driven by activated KRAS who currently have limited treatment options available. We believe this collaboration will significantly strengthen our KRAS program. We have developed comprehensive approaches to successfully tackle the oncogenic KRAS–RAF–MEK–ERK pathway from the ground up and this partnership is another key building block in our long-term strategy to bring novel treatments to patients in our quest to defeat intractable cancer types.” The collaboration has a strategic goal to focus on patients with gastrointestinal or lung cancers defined by KRAS mutations, sub-populations that currently need more effective therapeutic options. KRAS mutations occur in 1 in 7 of all human metastatic cancers making it the most frequently mutated cancer-causing gene, with mutation rates of more than 90 percent in pancreatic cancers, more than 40 percent in colorectal cancers and more than 30 percent in lung adenocarcinomas. Preclinical data has shown that the combination of Boehringer Ingelheim’s novel KRAS inhibitors with MEK inhibitors results in increased anti-tumor activity based on their complementary mechanisms of action in keeping KRAS-driven cancers in check. Lupin’s MEK inhibitors developed as part of its oncology pipeline have shown pre-clinical activity as a single agent as well as in combination. Furthermore, they have also shown early clinical benefit in a small subset of patients. Lupin will receive an upfront payment of $20 million and potential additional payments for successful achievement of defined clinical, regulatory and commercial milestones for a total deal value of more than $700 million. Additionally, Lupin will be entitled to receive double-digit royalties on the sales of the product. ]]> <![CDATA[USFDA issues CRL for Biocon's NDA for insulin glargine]]> https://biospectrumindia.com/news/95/14593/usfda-issues-crl-for-biocons-nda-for-insulin-glargine.html https://biospectrumindia.com/news/95/14593/usfda-issues-crl-for-biocons-nda-for-insulin-glargine.html Tue, 03 Sep 2019 16:45:00 +0530 Biocon said that the US Food and Drug Administration (US FDA) has issued a complete response letter (CRL) for the New Drug Application (NDA) for insulin glargine filed by partner Mylan.  The company said in statement that, the CRL has been issued pending completion of the corrective and preventive actions (CAPAs) submitted to the US FDA in response to the observations made at the conclusion of the pre-approval inspection of insulin manufacturing facility in Malaysia in June 2019. The company added that CRL did not identify any outstanding scientific issues with the application. We remain confident of the quality of our application and do not anticipate any impact of this CRL on the commercial launch timing of our Insulin glargine in the US. "We remain committed to global standards of quality & compliance and are working closely with our Partner and the regulator to complete these CAPAs to the satisfaction of the US FDA," added Biocon. Biocon also declared that The US Food and Drug Administration conducted a current good manufacturing practice (cGMP) inspection at one of biologics drug product facilities in Bengaluru from August 22 to August 30, 2019.  The inspection concluded with four observations which it believe will not impact supplies from this facility.We are confident of addressing these observations through a corrective and preventive action plan in a timely manner." The company said in statement. ]]> <![CDATA[DCGI approves Zydus to market biologic for rabies]]> https://biospectrumindia.com/news/95/14586/dcgi-approves-zydus-to-market-biologic-for-rabies.html https://biospectrumindia.com/news/95/14586/dcgi-approves-zydus-to-market-biologic-for-rabies.html Tue, 03 Sep 2019 11:35:00 +0530 Zydus has announced that it has received marketing authorization for TwinrabTM (RabiMabs) from the Drug Controller General of India (DCGI). The novel biologic which will be marketed under the brand name, Twinrab, is indicated in combination with rabies vaccine for rabies post-exposure prophylaxis. The United States Food and Drug Administration (USFDA) has granted an orphan drug status to this candidate. In 2008, Zydus had entered into an agreement with the World Health Organization (WHO) to explore opportunities in the development of a cocktail of monoclonal antibodies for the treatment of rabies. The use of rabies monoclonal antibodies could emerge as an innovative therapy and form a potent alternative to current blood derived rabies immunoglobulins (RIG’s) produced by vaccinating horses (ERIG) or humans (HRIG). WHO encourages the use of monoclonal antibodies over blood derived RIG where available and has identified the development of products containing two or more antibodies that bind to two different sites on the rabies virus as a research priority. Zydus’ Twinrab is the only therapy that meets this requirement. Speaking on the development, Mr. Pankaj R. Patel, Chairman, Zydus Group said, “After the successful launch of Lipaglyn, our first NCE, we are now ready to launch our Novel Biological Entity, TwinrabTM. Our journey of discovery and the ability to take NCEs and NBEs from lab to market, is in line with our commitment to innovate and bridge unmet healthcare needs. This approval marks a transformational next-gen therapy for rabies treatment as we take a step forward from RIG to Twinrab .” Zydus currently also manufactures and markets the rabies vaccine – VaxiRab N which is a WHO pre-qualified vaccine. ]]> <![CDATA[Glenmark receives ANDA approval for Pimecrolimus Cream, 1%]]> https://biospectrumindia.com/news/95/14574/glenmark-receives-anda-approval-for-pimecrolimus-cream-1.html https://biospectrumindia.com/news/95/14574/glenmark-receives-anda-approval-for-pimecrolimus-cream-1.html Fri, 30 Aug 2019 10:40:00 +0530 Glenmark Pharmaceuticals has been granted final approval by the USFDA for Pimecrolimus Cream, 1%, a generic version of Elidel®1 Cream, 1%, of Bausch Health US, LLC. According to IQVIATM sales data for the 12 month period ending July 2019, the Elidel® Cream, 1% market2 achieved annual sales of approximately $198.8 million. Glenmark’s current portfolio consists of 160 products authorized for distribution in the U.S. marketplace and 55 ANDA’s pending approval with the USFDA. ]]> <![CDATA[Granules India to divest its stake in its JV located in India]]> https://biospectrumindia.com/news/95/14566/granules-india-to-divest-its-stake-in-its-jv-located-in-india.html https://biospectrumindia.com/news/95/14566/granules-india-to-divest-its-stake-in-its-jv-located-in-india.html Thu, 29 Aug 2019 14:55:00 +0530 Granules India Ltd. has announced its intention to divest its entire equity shareholding in Granules OmniChem Private Limited (GOC) by selling its stake to its joint venture partner. GOC is an equal joint venture between Granules India Limited and S.A. Ajinomoto Omnichem N.V. (now doing business as Ajinomoto Bio-Pharma Services), an integrated contract development and manufacturing organization. The manufacturing facility of this joint venture entity is located in Visakhapatnam, India. Conclusion of this transaction is subject to fulfilment of certain closing conditions as well as customary government approvals. Krishna Prasad Chigurupati, Chairman and Managing Director, Granules India Limited said, “The proposed divestment of our 50% stake in the joint venture aligns with our focus on strengthening our core area of business. With this transaction, S.A. Ajinomoto Omnichem N.V. will take over full control of the CRAMS business. Through this deal we would like to extend our support to our joint venture partner for their business plan to integrate their small and large molecule businesses which in turn strengthens their business operation and client relations. I believe this is a win-win situation for both the companies as we continue to build upon our business model based on our area of concentration.” Granules India is a growing pharmaceutical manufacturing company with best in class facilities and is committed to operational excellence, quality and customer service. The Company produces Finished Dosages (FDs), Pharmaceutical Formulation Intermediates (PFIs) and Active Pharmaceutical Ingredients (APIs) which gives the customers flexibility and choice. ]]> <![CDATA[Alstrut launches ‘Cobotizur’ ]]> https://biospectrumindia.com/news/95/14563/alstrut-launches-cobotizur-.html https://biospectrumindia.com/news/95/14563/alstrut-launches-cobotizur-.html Thu, 29 Aug 2019 10:40:00 +0530 Alstrut is a company based out of Chennai offering robotics and end of line automation solutions to discrete manufacturing industries across India. Solutions include automated/semi-automated assembly lines, conveyors, work stations, end of line automation, etc.  Industry verticals where we have delivered projects are Automobile, Auto-component, Electrical, Electronics, FMCG, Food, Packaging, Pharma etc. The company has chosen PackPlus as a platform to launch our new product cobotizur’ which has applications specifically in the packaging industry i.e. FMCG, Food and Pharmaceutical. Anuj Bihani, Managing Director, Alstrut India Private Limited said “Cobotizur is a flexible palletizing system that combines a palletizing cell with a collaborative robot and it provides end-users the features needed to quickly setup a robot for palletizing boxes or cartons on a standard pallet. Not only does it relieve humans from the laborious task of stacking boxes, it enhances the efficiencies of the operators and hence increasing throughput.” The key features of Cobotizur is Quick Installation, Vertical 7th axis, Minimal footprint, Modular easy to move, Continuous operation, Easy programming, Save to use and Minimal maintenance” ‘Cobotizur’ is a modular, plug and play equipment which can be integrated with the UR10 or UR10e collaborative robot from Universal Robots to provide the user a ‘collaborative robot palletizer’, automating palletizing of carton boxes on to a pallet.  The cobotizur is shipped as an all-inclusive unit, inclusive of a vertical 7th axis, a custom designed vacuum gripper to grip carton boxes of varying sizes and weights and a vacuum pump. Deploying the cobotizur requires absolutely no expertise or programming knowledge. A simple one-time three-point calibration is all that is needed. Using the intuitive touch-panel interface, users can in a few minutes, enter the dimensions and weight of all SKU, storing over 200 SKU types. It has a compact foot print, enabling installation at existing site with minimal change in layout. The modular design also enables the palletizing solution to be relocated. System integrators or end-users worldwide need to follow five simple steps to deploy a safe palletizing solution at the End of Line in just a few hours.  The ‘platform approach’ of providing a plug and produce equipment, empowers users to now deploy a simplified palletizing solution which earlier was perceived as a complex project.   ]]> <![CDATA[Strides acquires USFDA approved manufacturing facility in the US]]> https://biospectrumindia.com/news/95/14547/strides-acquires-usfda-approved-manufacturing-facility-in-the-us.html https://biospectrumindia.com/news/95/14547/strides-acquires-usfda-approved-manufacturing-facility-in-the-us.html Wed, 28 Aug 2019 09:25:00 +0530 Strides Pharma Science Limited (Strides) has announced that its step  down  subsidiary  Strides  Pharma  Inc. (SPI)  has  acquired  a  USFDA (FDA)  approved  manufacturing  facility  in  Florida, US from Micelle BioPharma, Inc.  Micelle’s facility is based in Riviera Beach, Florida and is one of the very few manufacturing facilities in the US with a soft gel capsule (SGC) manufacturing suite for formulations with containment needs.  It is also the only FDA approved integrated manufacturing‐packaging SGC facility in the US.  The site has undergone several successful FDA inspections and has no outstanding FDA observations. SPI has acquired the manufacturing facility under an asset purchase agreement with Micelle Biopharma, Inc.  for  a  consideration  of  US$  0.5  Million  and  will  invest  up  to  US$  10  Million  to  build  incremental capabilities and add additional dosage formats. With the addition of the Florida site, Strides now has eight formulation sites globally catering to the regulated and emerging markets.   ]]> <![CDATA[Lupin signs commercial agreement with Creso Pharma for cannaQIX]]> https://biospectrumindia.com/news/95/14536/lupin-signs-commercial-agreement-with-creso-pharma-for-cannaqix.html https://biospectrumindia.com/news/95/14536/lupin-signs-commercial-agreement-with-creso-pharma-for-cannaqix.html Tue, 27 Aug 2019 09:00:00 +0530 Pharma major Lupin Limited has announced that its subsidiary in South Africa, ‘Pharma Dynamics’ has signed a Commercial Agreement with Creso Pharma for the hemp oil based cannaQIX®. Creso affords Pharma Dynamics sole distribution rights of its organic, broad spectrum hemp oil nutraceutical, cannaQIX®10, across South Africa, Namibia, Botswana, Zimbabwe, Swaziland, Lesotho, Angola, Mozambique and Uganda. The cannaQIX® range of products are cannabidiol (CBD) hemp oil-based nutraceuticals, which contain full spectrum organic hemp oil extracts with CBD, vitamins and zinc, aiming to reduce stress and to support mental and nervous functions. Cannabidiol is one of many identified cannabinoids in cannabis plants and has been linked to improved anxiety, pain management, movement therapy and cognition. The products are sugar free and contain no Tetrahydrocannabinol (THC) – the principal psychoactive constituent of cannabis. The standardized, user-friendly strength and formulation allows precise dosage control, ensuring a reliable and stable effect over several days. The cannaQIX® range has been developed per Good Manufacturing Practice standards and is produced in Switzerland by Creso’s partner, Swiss-based food and pharma development company, Domaco, Dr. med Aufdermaur AG (Domaco) to the highest Swiss quality with a “Swiss Made” label. Pharma Dynamics CEO, Erik Roos, said that in line with our organization’s ethos of increasing access to affordable, quality medicines, we have identified Creso Pharma as a partner of choice. This partnership enables us to bring novel products to patients in South Africa. “Creso Pharma is globally recognized as a leader in the production of cannabis products with distribution agreements already in place in various countries in Europe and Asia-Pacific. The company cultivates its cannabis at its state-of-the-art Mernova Medical facility in Windsor, Nova Scotia and its pharmaceutical leadership team ensures cutting edge science and research to develop, innovative cannabis and hemp derived products. We hope that this agreement will form the foundation of a longstanding relationship as we grow our footprint from nutraceuticals into the scheduled market as well.” Dr. Miri Halperin Wernli, Creso Pharma’s CEO and co-founder said, that the evolving regulatory situation in South Africa is providing a solid foundation on which to build this close relationship with Pharma Dynamics. “We are encouraged to see a wide range of opportunities opening up to bring premium hemp oil nutraceutical products to customers in South Africa.” Pharma Dynamics hopes that the products will be available at leading retail pharmacies by year end. cannaQIX®10 is available without a prescription and comes in packs of 24 lozenges. ]]> <![CDATA[Glenmark receives ANDA approval for Fulvestrant Injection ]]> https://biospectrumindia.com/news/95/14530/glenmark-receives-anda-approval-for-fulvestrant-injection-.html https://biospectrumindia.com/news/95/14530/glenmark-receives-anda-approval-for-fulvestrant-injection-.html Mon, 26 Aug 2019 12:25:00 +0530 Glenmark Pharmaceuticals has been granted final approval by the United States Food & Drug Administration for Fulvestrant Injection, 250 mg/5 mL (50 mg/mL). It is a generic version of Faslodex® Injection, 250 mg/5 mL (50 mg/mL), of AstraZeneca Pharmaceuticals LP. According to IQVIATM sales data for the 12 month period ending June 2019, the Faslodex® Injection, 250 mg/5 mL (50 mg/mL) market2 achieved annual sales of approximately $549.9 million. Glenmark’s current portfolio consists of 159 products authorized for distribution in the U.S. marketplace and 56 ANDA’s pending approval with the USFDA. ]]> <![CDATA[Lupin launches generic antidepressant drug ]]> https://biospectrumindia.com/news/95/14517/lupin-launches-generic-antidepressant-drug-.html https://biospectrumindia.com/news/95/14517/lupin-launches-generic-antidepressant-drug-.html Fri, 23 Aug 2019 13:05:00 +0530 Pharma major Lupin Limited (Lupin) announced the launch of Fluoxetine Tablets USP, 10 mg and 20 mg, having received an approval from the United States Food and Drug Administration (U.S. FDA) earlier. Lupin’s Fluoxetine Tablets USP, 10 mg and 20 mg, is the generic equivalent of Eli Lilly and Company’s  Prozac® Tablets, 10 mg and 20 mg. It is indicated in the treatment of: Major Depressive Disorder (MDD) Fluoxetine is indicated for the acute and maintenance treatment of Major Depressive Disorder in adult patients and in pediatric patients aged 8 to 18 years Obsessive Compulsive Disorder (OCD) Fluoxetine is indicated for the acute and maintenance treatment of obsessions and compulsions in adult patients and in pediatric patients aged 7 to 17 years with Obsessive Compulsive Disorder (OCD) Bulimia Nervosa Fluoxetine is indicated for the acute and maintenance treatment of binge‑eating and vomiting behaviors in adult patients with moderate to severe Bulimia Nervosa. Panic Disorder Fluoxetine is indicated for the acute treatment of Panic Disorder, with or without agoraphobia, in adult patients. Fluoxetine Tablets USP, 10 mg and 20 mg (RLD: Prozac®) had an annual sales of approximately USD 53 million in the US (IQVIA MAT June 2019).       ]]> <![CDATA[Lupin gets USFDA nod for Hydrocortisone Valerate cream]]> https://biospectrumindia.com/news/95/14507/lupin-gets-usfda-nod-for-hydrocortisone-valerate-cream.html https://biospectrumindia.com/news/95/14507/lupin-gets-usfda-nod-for-hydrocortisone-valerate-cream.html Thu, 22 Aug 2019 14:45:00 +0530 Pharma major Lupin Limited (Lupin) announced that it has received approval for its Hydrocortisone Valerate Cream USP, 0.2% from the United States Food and Drug Administration (U.S. FDA). Lupin’s Hydrocortisone Valerate Cream USP, 0.2%, is the generic version of Westcort® Cream, 0.2%, of Sun Pharmaceutical Industries, Inc. It is indicated for the relief of the Inflammatory and pruritic manifestations of corticosteroid responsive dermatoses in adult patients. Hydrocortisone Valerate Cream USP, 0.2%, (RLD: Westcort®) had an annual sales of approximately USD 15 million in the US (IQVIA MAT March 2019). ]]> <![CDATA[Lupin divests Kyowa Criticare to Neopharma group]]> https://biospectrumindia.com/news/95/14506/lupin-divests-kyowa-criticare-to-neopharma-group.html https://biospectrumindia.com/news/95/14506/lupin-divests-kyowa-criticare-to-neopharma-group.html Thu, 22 Aug 2019 14:20:00 +0530 Pharma major Lupin Limited (including its subsidiaries together referred to as   Lupin) announced that it has entered into a definitive agreement through its Japanese subsidiary Kyowa (Kyowa Pharmaceutical Industry Co., Ltd.) for the sale of its Japanese Injectables business and related assets in Japan to neo ALA Co. Ltd, a wholly owned subsidiary of Neopharma group, the UAE’s largest pharmaceutical manufacturer headquartered in Abu Dhabi. The plant and associated facilities are based out of Atsugi, Japan and has been engaged in sales and contract manufacturing of injectable products to meet various medical needs. Under the terms of the agreement, Lupin has agreed to sell all the issued and outstanding share capital in Kyowa Criticare Co. Ltd to neo ALA Co. Ltd. The transaction is subject to customary closing conditions and has been approved by the Board of Directors of Lupin. This transaction does not involve or affect the other operations of Kyowa, namely research, manufacturing, marketing and distribution of oral solids and other dosage forms in Japan. “The divestiture of our Injectables business in Japan is a step towards streamlining our Japan operations and bringing sharper focus on building a hybrid (Brand/ generics) pharma model in Japan. We believe that Neopharma group is the right partner for Kyowa Criticare as they appreciate the strategic importance of this business unit and would be able to deliver value to business partners and customers, leveraging Kyowa Criticare’s people who are critical assets,” said Fabrice Egros, President Lupin APAC and Representative Director – Kyowa. Suresh Nandiraju, Chief Operating Officer of Neopharma, said, “This acquisition is synergetic and will strengthen our product offerings in the Japanese market, a focus market for Neopharma group for driving long-term, sustainable growth by leveraging our global presence.” ]]> <![CDATA[Zydus initiates phase II trial for NAFLD drug]]> https://biospectrumindia.com/news/95/14500/zydus-initiates-phase-ii-trial-for-nafld-drug.html https://biospectrumindia.com/news/95/14500/zydus-initiates-phase-ii-trial-for-nafld-drug.html Thu, 22 Aug 2019 14:00:00 +0530 Zydus Cadila, an innovation-driven, global pharmaceutical company, announced that it has initiated a Phase 2 clinical trial for evaluating the effect of Saroglitazar Mg in the treatment of NonAlcoholic Fatty Liver Disease (NAFLD) in women with polycystic ovary syndrome (PCOS). The EVIDENCES VII trial is currently recruiting patients across several clinical sites in the United States of America and Mexico. Research suggests that in women with polycystic ovary syndrome (PCOS), the risk for NonAlcoholic Fatty Liver Disease is increased. PCOS affects fertility and also significantly increases metabolic complications. Saroglitazar Magnesium is an investigational molecule in USA, undergoing clinical evaluation for treatment of liver diseases like NAFLD with PCOS, Non-Alcoholic SteatoHepatitis (NASH) and Primary Biliary Cholangitis (PBC). Speaking on the development, Mr. Pankaj R. Patel, Chairman, Zydus Group said, “We are happy with the progress of our investigational molecule, Saroglitazar Mg in the study for addressing several unmet healthcare needs including Non-Alcoholic SteatoHepatitis and NAFLD. Our research programme aims at bringing innovative therapies that make a difference to human lives in keeping with our mission to create healthier communities.” The trial will evaluate the change in hepatic fat content from baseline following 24 weeks of treatment as measured by MRI-PDFF in patients treated with Saroglitazar Magnesium as compared to placebo as the primary endpoint. The secondary endpoints of the trial also include measurements of liver enzymes, insulin resistance, liver fibrosis, liver stiffness, BMI, waist circumference, MRIderived measures of total liver fat index, MRI-derived measures of total liver volume, lipid and lipoprotein levels, SHBG level, ovarian function, free androgen index and pharmacokinetic parameters. ]]> <![CDATA[Health Meets Hope at OPPI Health Dialogue 2019]]> https://biospectrumindia.com/news/95/14501/health-meets-hope-at-oppi-health-dialogue-2019.html https://biospectrumindia.com/news/95/14501/health-meets-hope-at-oppi-health-dialogue-2019.html Thu, 22 Aug 2019 11:50:00 +0530 The OPPI Health Dialogue 2019 held in the nation’s capital saw its mission ‘Health Meets Hope’ focus on the convergence of regulations, financing, technology and advanced pharma science to realize the true healthcare potential for patients across the country. The Health Dialogue 2019, curated by the Organisation of Pharmaceutical Producers of India (OPPI), witnessed policy makers, regulators, global experts, patient groups and members of the healthcare and pharmaceutical industry coming together to discuss the need to build an inclusive healthcare ecosystem, with patient well-being at the core. A key initiative announced on the occasion was the launch of a nationwide digital campaign, #RefreshingResearch, across pharma colleges in the country to highlight the role of science and research in improving patient lives. Kanchana TK, Director General, OPPI said; “The research-based pharmaceutical industry is proud to be playing its part in the quest to find effective and sustainable solutions to today’s most pressing health concerns. Thanks to the innovative medicines developed by our member companies, patients all over the world are living longer, healthier and more productive lives.  #Refreshing Research, OPPI’s digital campaign to be launched shortly aims at engaging younger minds, thus enabling them to be ambassadors for Science and Research. It aims at building a community of researchers who are not afraid to take that one brave step into the dark blind alley and come up with solutions that are not merely confined to addressing problems, but come up with treatments and cures that were hitherto unknown.” Beginning with the National Institute of Pharmaceutical Education and Research (NIPERs), under the aegis of the Department of Pharmaceuticals, Ministry of Chemicals & Fertilizers, #Refreshing Research proposes to initiate an inter-collegiate competition among pharma colleges across the country.   The contest will encourage participants to come up with innovation/incremental innovation in any of the following areas: Women’s health; Public Health – AMR & Vaccines; Mental Health; Supply chain management and Sustainability in the pharma industry. An online jury, along with broader participation from the student community, who can publicly vote for their favourites, will award scores to participants.  The final scores will have winners emerge with their winning ideas. The Government’s announcement of Ayushman Bharat has stirred a nation-wide interest in the subject of healthcare access and universal health coverage.  #HealthDialogue2019 provided a platform to discuss multifaceted approaches to developing an innovative and sustainable healthcare financing model. Vaidheesh, President, OPPI and Managing Director - India & Vice President – South Asia, Glaxo SmithKline Pharmaceuticals Ltd. said, “India’s public health system is taking steps in the right direction, with the introduction of Ayushman Bharat and most individual states having health coverage in place. With the end objective of providing solutions to healthcare coverage for all, the PwC-OPPI study titled ‘Role of Healthcare Financing in improving access to state of the art treatments’ illustrates the mechanism of market-based model for financing treatment of serious conditions like lung cancer, for example. This small step, we believe, will be the beginning of solutioning healthcare coverage for serious ailments in providing a multiple stakeholder innovative financing model.” On the role of technology in impacting health outcomes, he elaborated, “A technology enabled path to achieve better health outcomes could have significant economic benefit to the country. The BCG-OPPI report titled, ‘Leapfrogging India’s health outcomes’  clearly outlines the need for Government and  private sector to come together to create a new ecosystem that factors the convergence of  healthcare and technology towards implementation of healthcare initiatives. With the Government’s intent to increase healthcare spend to 5-6% of GDP, it calls for multi-stakeholder participation, in all areas of patient care.  The time to unlock the healthcare potential for citizens in India has arrived and the next few years are critical as they will put India on the leap frogging trajectory of enhanced health.” Mary Kom, celebrated Indian Olympic Boxer was also present at the Summit.   Through her session she highlighted the fact that "Staying healthy and fit is critical not just for sports but for living itself.  I am a living proof to Health Meets Hope, the mission for the OPPI Health Dialogue 2019. As a winner both inside and outside the boxing ring, I believe that good health makes life hopeful and fuller. I recognize and appreciate the years of research devoted by researchers in towards transforming human lives, as it is similar to the years of rigorous training a sportsperson undergoes.  And success lies in reaching newer heights and setting benchmarks that push boundaries.  So to all the researchers out there, keep refreshing your research and let’s continue to punch above our weight.” The occasion also witnessed eminent personalities who have contributed in building a patient-focused healthcare ecosystem in the country recognised for their outstanding contributions.  Lifetime Achievement Award: Dr Sarada Menon, Founder & Advisor: Schizophrenia Research Foundation (SCARF) for her tireless dedication towards improving mental health in India. Late Shri D G Shah, Founder of Indian Pharmaceutical Alliance for his long-standing contribution to the pharmaceutical industry in India. Special Recognition: Dr Gagandeep Kang, Executive Director, Translational Health Science and Technology Institute (THSTI) for her unparalleled work in studying the transmission, development and prevention of enteric infections and their sequelae in children in India. Dr Y K Gupta, Principal Advisor (Projects), THSTI, for his tireless efforts in building an innovation-driven pharmaceutical ecosystem in India. Access Champions 2019: Dr A Seema, Centre for Materials for Electronics Technology (C-MET) was recognised for her contribution towards improving women’s health.  Geeta Verma, Shakardahra Health sub-center in Jhanjeli block of Mandi was recognised for her work in child health. Mritunjay Kumar Tiwary, Project Head & Trustee, Akhand Jyoti Eye Hospitals for his commitment towards improving healthcare access in India. OPPI Scientist Awards 2019: Dr Gajendra Pal Singh Raghava, Head Computational Biology, Indraprastha Institute of Information Technology won the Scientist of the year award.  Dr Nirmala Jagadish, Staff Scientist, Cancer Research Program (CRP), National Institute of Immunology bagged the Woman Scientist of the year award Dr Sandip B Bharate, Principal Scientist, Medicinal Chemistry Division, CSIR - Indian Institute of Integrative Medicine was recognised as the Young Scientist of the year.  Some recommendations from the discussions of the Summit: A clear solution for health insurance coverage of critical illnesses at the state level through a mutil-stakeholder engagement A tech enabled path to achieve better health outcomes could have significant economic benefit to the country As research-based pharma industry aims to bring the fruits of research to patients across the world, there is need for a robust policy framework governing healthcare regulations in the country   ]]> <![CDATA[Alembic Pharma, Vadodara announces completion of USFDA inspection ]]> https://biospectrumindia.com/news/95/14494/alembic-pharma-vadodara-announces-completion-of-usfda-inspection-.html https://biospectrumindia.com/news/95/14494/alembic-pharma-vadodara-announces-completion-of-usfda-inspection-.html Wed, 21 Aug 2019 17:00:00 +0530 Alembic Pharmaceuticals Limited is one of the leading pharmaceutical companies in India. The company aims to explore opportunities in the therapeutic areas such as Dermatology, Oncology, and Injectable Formulations. APL also has also co-promoted a company focused on discovery and development of innovative, small molecule drugs that target signal transduction networks and ion channels for the treatment of cancer, inflammation, autoimmune diseases and metabolic disorders.   The company has established a state-of-the-art research facility – Alembic Research Centre (ARC)-including formulation research, and 150-bed bioequivalence facility at Vadodara, Gujarat. Additionally, APL has recently invested in ultra-modern R&D center at Hyderabad. APL is one of the leading players in the industry to have invested about 11% of its turnover in R&D. USFDA inspected Alembic Pharmaceuticals Ltd bioequivalence facility at Vadodara between August 12, 2019 and August 16, 2019 and also between August 12, 2019 and August 20, 2019 for bioequivalence bioanalytical and bioequivalence clinical compliance. US Food & Drug Administration (USFDA) through its recent inspection of Alembic Pharma Vadodara facility concluded that there were no 483s issued at the end of the inspection. An FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator has observed any condition that in their judgment may constitute violation of the Food Drug and Cosmetic (FD&C) Act and related Acts. ]]> <![CDATA[Dr. Reddy's launches Vigabatrin Powder for Oral Solution in US]]> https://biospectrumindia.com/news/95/14493/dr-reddys-launches-vigabatrin-powder-for-oral-solution-in-us.html https://biospectrumindia.com/news/95/14493/dr-reddys-launches-vigabatrin-powder-for-oral-solution-in-us.html Wed, 21 Aug 2019 16:35:00 +0530 Dr. Reddy’s Laboratories Ltd. is an integrated pharmaceutical company, committed to providing affordable and innovative medicines for healthier lives. Through its three businesses - Pharmaceutical Services & Active Ingredients, Global Generics and Proprietary Products.  Dr. Reddy’s Laboratories Ltd. has announced the launch of Vigabatrin Powder for Oral Solution, USP in 500 mg per packet, a therapeutic equivalent generic version of Sabril® (vigabatrin) Powder for Oral Solution, USP, approved by the U.S. Food and Drug Administration (USFDA).  The Sabril® brand and generic had U.S. sales of approximately $274 million MAT for the most recent twelve months ending in June 2019 according to IMS Health. Dr. Reddy’s Vigabatrin Powder for Oral Solution, USP is available in 500 mg per packet in count size of 50 per carton. ]]> <![CDATA[Sustainable Manufacturing Practices Needed to Combat Growing AMR]]> https://biospectrumindia.com/news/95/14486/sustainable-manufacturing-practices-needed-to-combat-growing-amr.html https://biospectrumindia.com/news/95/14486/sustainable-manufacturing-practices-needed-to-combat-growing-amr.html Tue, 20 Aug 2019 16:15:00 +0530 Centrient Pharmaceuticals, a global leader in sustainable antibiotics manufacturing, in partnership with Indian Institute of Technology - Delhi, organized a workshop on ‘Sustainability Through Excellence in Manufacturing’ (STEM) in Seoul recently. The workshop imparted training and education on advanced clean and sustainable manufacturing techniques for pharmaceuticals. The session was attended by nearly 50 participants from Manufacturing, R&D, Regulatory Affairs, Quality Control/Assurance and Purchasing departments of leading pharmaceutical companies in Korea. The World Health Organization (WHO) recognizes Antimicrobial Resistance (AMR) as one of the top ten threats to public health worldwide. According to the AMR Review (2014), nearly 700,000 people die each year due to AMR, and by 2050, this number is projected to reach 10 million per year unless strong actions against the drivers of AMR are taken. Next to misuse and overuse of antibiotics, environmental factors like release of inadequately treated antibiotic manufacturing effluent into the environment play an important role in development of drug resistant ‘superbugs’. Tim Rutten, Business Director – Asia Pacific and Africa, Centrient Pharmaceuticals stated, “To effectively tackle AMR, a ‘One Health’ approach with multi-sectoral involvement is required, with governments, civil society, and industry playing their part. Many treatments and medical procedures, including surgery, we take for granted would be impossible without antibiotics and it is essential to safeguard these essential medicines for future generations. At Centrient Pharmaceuticals, we believe that the pharmaceutical industry needs to take the lead to ensure antibiotics are produced sustainably and to prevent the release of effluent containing antimicrobial activity into the environment. Advanced technologies and processes are available to remove antibiotic residues from pharmaceutical waste. Through STEM workshops, we aim to share expertise with our industry partners to jointly raise the bar and combat AMR.” A WHO report revealed that overuse of antibiotics was a major factor contributing to resistance in South Korea, with an average of 28 defined daily doses (DDD) being used per 1000 people in 2015, higher than other developed countries. Over the past years, South Korea has made advancements in AMR containment and in 2016, launched their National Action Plan on AMR (2016-2020) in line with the One Health approach. Besides promoting prudent use of antibiotics, Korea’s National Action Plan focuses on strengthening the surveillance system, which is expected to impact monitoring of environmental factors of AMR as well. The Centers for Disease Control and Prevention of South Korea established a customized surveillance system for South Korea, called Kor-GLASS, in 2016, which is now being scaled up. Prof. Anurag S. Rathore, Indian Institute of Technology, Delhi stated“Adoption of advanced technological innovation is needed to ensure that pharmaceutical manufacturing becomes sustainable and does not contribute to the rise in AMR. Since Korea is a manufacturer as well as consumer of antibiotics, training of representatives of pharmaceutical companies can help address multiple facets of the issue. The STEM workshops introduce participants to clean manufacturing and waste management practices to reduce antibiotic pollution, which can eventually also be scaled up to other sectors.” To further R&D, by 2017, Korea had allocated funds worth 65 million euros to AMR related research, including developing new-age antimicrobials and modernization of livestock and poultry management systems to eliminate non-therapeutic use of antibiotics.               ]]> <![CDATA[Glenmark receives approval for combination drug for diabetes]]> https://biospectrumindia.com/news/95/14469/glenmark-receives-approval-for-combination-drug-for-diabetes.html https://biospectrumindia.com/news/95/14469/glenmark-receives-approval-for-combination-drug-for-diabetes.html Tue, 20 Aug 2019 09:00:00 +0530 Glenmark Pharmaceuticals has received regulatory approval to market a combination of its novel, patent protected and globally-researched sodium glucose co-transporter-2 (SGLT2) inhibitor Remogliflozin etabonate (Remogliflozin) and Metformin Hydrochloride (Metformin) film coated tablets in India. The drug is indicated in the treatment of type-2 diabetes mellitus in adults. Glenmark will commercialize the product under the brand names ‘Remo-M’ and Remozen-M’.  Earlier in April 2019, Glenmark received regulatory approval for Remogliflozin etabonate 100 mg tablets, twice daily, after successfully completing Phase-3 clinical trials in which Remogliflozin demonstrated good efficacy and safety profile in a head-to-head comparison against Dapagliflozin. With this approval Glenmark became the first company in the world to launch the novel SGLT2 inhibitor Remogliflozin with India being the first country to get access to this innovative drug. Glenmark subsequently launched Remogliflozin in India under the brand names ‘Remo’ and ‘Remozen’.   Glenmark has now received regulatory approval for a combination of Remogliflozin and Metformin film coated tablets. The approved dosage strengths are 100 mg of Remogliflozin combined with either 500 mg or 1,000 mg of Metformin. This combination is indicated as an adjunct to diet and exercise to improve glycemic control in type-2 diabetes mellitus patients. Sujesh Vasudevan, President, India Formulations, Middle East and Africa at Glenmark Pharmaceuticals said, “The approval for Remogliflozin and Metformin combination is a testament of our commitment towards revolutionizing diabetes management in India. Glenmark is a pioneer in providing access to the latest treatment options to diabetes patients in India. Earlier this year, we launched Remogliflozin with an aim to increase patients’ access to SGLT2 inhibitors as this class of drugs have proven benefits for effective diabetes management. As the prevalence of diabetes continues to rise rapidly, we are pleased to offer an additional treatment option to patients. This approval for combination of Remogliflozin and Metformin will only help us get closer to our goal of providing an effective, high quality and world-class treatment option and improving access to SGLT2 inhibitors for patients in India.” The company had launched Remogliflozin as a mono-therapy, at a breakthrough price which is over 50% lower than the existing SGLT2 inhibitors available in India.  Prior to the launch of Remogliflozin, the average per day therapy cost of SGLT2 inhibitors in India was about Rs. 55.   ]]> <![CDATA[Dr. Reddy's launches Versavo in India ]]> https://biospectrumindia.com/news/95/14474/dr-reddys-launches-versavo-in-india-.html https://biospectrumindia.com/news/95/14474/dr-reddys-launches-versavo-in-india-.html Mon, 19 Aug 2019 15:30:00 +0530 Dr. Reddy’s Laboratories Ltd. has launched Versavo® (bevacizumab), a biosimilar of Roche’s Avastin® in India, indicated for the treatment of several types of cancers (metastatic colorectal cancer, non-squamous non-small cell lung cancer, recurrent glioblastoma, metastatic renal cell carcinoma, cervical cancer, metastatic breast cancer and epithelial ovarian, fallopian tube and primary peritoneal cancer). Dr. Reddy’s Versavo® is available in strengths of 100mg and 400mg single use vials. Commenting on the launch, MV Ramana, CEO - India and Emerging Markets, Dr. Reddy’s Laboratories, said, “We regard the good health of our patients as our responsibility and are committed to ensure that they always have access to the medicines they need. The launch of Versavo® is another step in that journey and helps strengthen our Oncology portfolio.” Dr. Raymond De Vré, Global Head, Biologics, Dr. Reddy’s Laboratories added “Versavo® will help improve access to high quality therapy at an affordable cost, addressing the needs of patients with different cancers in India.” Avastin® and its biosimilars had India sales of approximately INR 223 Crore MAT for the most recent twelve months ending in December 2018, according to Ipsos. Dr. Reddy’s now has six biosimilar products commercialized in India and various emerging markets and an active development pipeline of several biosimilar products in the oncology and immunology space. ]]> <![CDATA[SII invents first ever heat stable Rotavirus vaccine]]> https://biospectrumindia.com/news/95/14466/sii-invents-first-ever-heat-stable-rotavirus-vaccine.html https://biospectrumindia.com/news/95/14466/sii-invents-first-ever-heat-stable-rotavirus-vaccine.html Mon, 19 Aug 2019 11:40:00 +0530 In a landmark development, the world's largest vaccine manufacturer by number of doses produced and sold globally (more than 1.5 billion doses last year), Serum Institute of India (SII) and the National Institute of Allergy and Infectious Diseases (NIAID), part of the U.S. National Institutes of Health (USA), joined hands to create the first-ever heat-stable Rotavirus vaccine in the world. Albert Z. Kapikian, M.D., a pioneering virologist at NIAID defined the mode of transmission of Rotavirus, identified the viral proteins critical for triggering an immune response, and formulated a vaccine that targeted several important Rotavirus strains. In 2005, NIAID and Serum Institute of India Pvt. Ltd. (SIIPL) joined hands for the development of a Rotavirus Vaccine. The collaboration, through a license agreement, aimed at finding a solution that was not just affordable, but would reduce the operational difficulties faced by the poor countries for vaccine distribution and administration. Both parties were cognizant of the fact that the single biggest challenge faced by the distribution channel was the ability to maintain the vaccine under refrigeration. Costs associated with the maintenance of a cold chain can be in the region of 200 Million Dollars a year, which clearly adds to the cost of vaccination. SII worked to develop a heat stable formulation to overcome this problem and Rotasiil®, is today the only Rotavirus vaccine to have the ability to withstand extreme temperatures. It can be stored at temperatures up to 25°C throughout its shelf life of 30 months, which makes Rotasiil® completely unique from other vaccines that require refrigeration for storage and transportation. The vaccine will revolutionize healthcare for children across the globe due to its potency, longevity and ability to endure severe changes in temperature, thereby reducing wastage and storage costs. Introduction of the Rotasiil® vaccine, with its long shelf life and lack of need for refrigeration, is a timely boon for millions affected by Rotavirus. SII and NIAID’s joint endeavor in creating the heat-stable Rotasiil® vaccine effectively fills the need, reducing costs and relieving bottlenecks in the vaccine supply-chain. This breakthrough invention has also been awarded a patent for being the first-of-its-kind thermostable Rotavirus vaccine by United States Patent and Trademark Office (USPTO). In addition to the patent, Rotasiil® has also been assigned the VVM 250 label, which had to be specially developed for Rotasiil for its high heat stability. Accepted by the World Health Organization (WHO), the VVM250 label on Rotasiil® helps immunization managers across the world to store it at room temperature, while allowing excursion in temperatures during storage and transportation up to 39°C. Speaking about this development, Mr. Adar Poonawalla, CEO of SII said, “Providing a healthy life to their children is the dream of every parent, and the thermo stabilizing of the Rotasiil® vaccine is one step towards that direction. Among all the barriers that led to decreasing of vaccine potency, heat-instability ranks highest causing the vaccine to become ineffective and therefore increasing wastage. Rotasiil® will help reduce misapplication, wastefulness, cost for logistics, increase availability and therefore, help millions more, lead a healthier life.” Adding to the above, Dr. Rajeev Dhere, Executive Director of SII said, “The enhanced penetration and increased longevity of the Rotasiil® vaccine will not only lead to more infants being protected but will also reduce the number of clinic visits and associated medical costs. Receiving a Patents for Humanity award, by the United States Patent and Trade Office is extremely prestigious for everyone associated with it, especially those of us at SII. In addition to the patent awarded, the development of the VVM label indicator is no less than a breakthrough achievement in our fight to eradicate this severe health hazard.” SII and NIAID, jointly developed the heat-stable Rotasiil® and received two prestigious awards in 2018.  The Deal of Distinction award was given by Licensing Executive society of US and Canada (LES) for development of ROTASIIL®, a low-cost, temperature tolerant Rotavirus vaccine for developing countries in the category of Industry-University-Government Interface (IUGI) Sector. The Patent for Humanity award was given by the United States Patent and Trademark Office. The Government of India is already using ROTASIIL in the Universal Immunization Programme. ROTASIIL is also available in India’s private market. It is also exported to several countries.   ]]> <![CDATA[Sun Pharma to develop more generic products in China]]> https://biospectrumindia.com/news/95/14465/sun-pharma-to-develop-more-generic-products-in-china.html https://biospectrumindia.com/news/95/14465/sun-pharma-to-develop-more-generic-products-in-china.html Mon, 19 Aug 2019 09:00:00 +0530 Sun Pharmaceutical Industries Ltd. has announced that one of its wholly owned subsidiaries has granted an exclusive license to a subsidiary of China Medical System Holdings Ltd. (CMS) to develop and commercialize seven generic products in Mainland China. The collaboration with CMS now covers eight generic products including the seven products referred above. The total addressable market size for all these eight products is about US$ 1 billion (as per recent IQVIA data) in Mainland China. The initial term of the agreement shall be 20 years from the first commercial sale of the respective products in Mainland China and may be extended for additional three years’ as per mutual agreement of the two parties. “This collaboration gives us entry into the Chinese generic pharmaceutical market. We see lot of potential in China for both, our generics and speciality portfolio. With more than 65% generics penetration, China represents a significant opportunity for generic pharmaceutical companies,” said Dilip Shanghvi, Managing Director, Sun Pharma. In June 2019, Sun Pharma had announced collaboration with CMS on two speciality products, Tildrakizumab and Cyclosporine A 0.09% (CsA) eye drops for the Greater China market. ]]> <![CDATA[FDA approves Roche’s entrectinib for people with lung cancer ]]> https://biospectrumindia.com/news/95/14462/fda-approves-roches-entrectinib-for-people-with-lung-cancer-.html https://biospectrumindia.com/news/95/14462/fda-approves-roches-entrectinib-for-people-with-lung-cancer-.html Fri, 16 Aug 2019 12:50:00 +0530 Roche has announced that the US Food and Drug Administration (FDA) has approved Rozlytrek™ (entrectinib) for the treatment of adults with ROS1-positive, metastatic non-small cell lung cancer (NSCLC). The FDA has also granted accelerated approval to Rozlytrek for the treatment of adult and paediatric patients 12 years of age and older with solid tumours that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have progressed following treatment or have no satisfactory alternative therapy. These approvals are based on results from the integrated analysis of the pivotal Phase II STARTRK-2, Phase I STARTRK-1 and Phase I ALKA-372-001 trials, and data from the Phase I/II STARTRK-NG study. Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development said, “Rozlytrek’s FDA approval for two rare types of cancer is an important advance for patients, combining a targeted medicine and genomic testing to bring this new treatment option to patients who are waiting. Rozlytrek is the first FDA-approved treatment that selectively targets both ROS1 and NTRK fusions, and, importantly, has also shown responses in these rare cancer types that have spread to the brain.” The most common adverse reactions (≥20 percent) with Rozlytrek were fatigue, constipation, altered sense of taste (dysgeusia), swelling (oedema), dizziness, diarrhoea, nausea, nervous system disorders (dysaesthesia), shortness of breath (dyspnoea), muscle pain (myalgia), cognitive impairment, increased weight, cough, vomiting, fever (pyrexia), joint pain (arthralgia) and vision disorders. The FDA’s Accelerated Approval Program allows conditional approval of a medicine that fills an unmet medical need for a serious or life-threatening disease or condition. The accelerated approval for NTRK gene fusion-positive solid tumors is based on tumour response rate and durability of response, and continued approval may be contingent upon verification and description of clinical benefit in the confirmatory trials. Biomarker testing for ROS1 in NSCLC and NTRK gene fusions across all solid tumours is the only way to identify people who are eligible for treatment with Rozlytrek. Roche is leveraging its expertise in developing personalised medicines and advanced diagnostics, in conjunction with Foundation Medicine, to help identify people with ROS1 and NTRK gene fusions. Foundation Medicine will submit FoundationOne®CDx to the FDA for approval as a companion diagnostic for Rozlytrek. An FDA-approved companion diagnostic for Rozlytrek is not available at this time.     ]]> <![CDATA[Roche announces first FDA approved tumour agnostic medicine]]> https://biospectrumindia.com/news/95/14456/roche-announces-first-fda-approved-tumour-agnostic-medicine.html https://biospectrumindia.com/news/95/14456/roche-announces-first-fda-approved-tumour-agnostic-medicine.html Fri, 16 Aug 2019 10:45:00 +0530 Roche has announced that the US Food and Drug Administration (FDA) has approved Rozlytrek™ (entrectinib) for the treatment of adults with ROS1-positive, metastatic non-small cell lung cancer (NSCLC). ROS1 is a tyrosine kinase, which plays a role in controlling how cells grow and proliferate. When a ROS1 gene fusion occurs, cancer cells grow and proliferate in an uncontrolled manner. Blocking this abnormal signalling can cause tumour cells to shrink or die. The FDA has also granted accelerated approval to Rozlytrek for the treatment of adult and paediatric patients 12 years of age and older with solid tumours that have a neurotrophic tyrosine receptor kinase (NTRK) gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have progressed following treatment or have no satisfactory alternative therapy. These approvals are based on results from the integrated analysis of the pivotal Phase II STARTRK-2, Phase I STARTRK-1 and Phase I ALKA-372-001 trials, and data from the Phase I/II STARTRK-NG study. The FDA’s Accelerated Approval Program allows conditional approval of a medicine that fills an unmet medical need for a serious or life-threatening disease or condition. The accelerated approval for NTRK gene fusion-positive solid tumors is based on tumour response rate and durability of response, and continued approval may be contingent upon verification and description of clinical benefit in the confirmatory trials. Biomarker testing for ROS1 in NSCLC and NTRK gene fusions across all solid tumours is the only way to identify people who are eligible for treatment with Rozlytrek. Roche is leveraging its expertise in developing personalised medicines and advanced diagnostics, in conjunction with Foundation Medicine, to help identify people with ROS1 and NTRK gene fusions. Foundation Medicine will submit FoundationOne®CDx to the FDA for approval as a companion diagnostic for Rozlytrek. An FDA-approved companion diagnostic for Rozlytrek is not available at this time. ]]> <![CDATA[Sun Pharma announces licensing agreement with CSIR-IICT]]> https://biospectrumindia.com/news/95/14448/sun-pharma-announces-licensing-agreement-with-csir-iict.html https://biospectrumindia.com/news/95/14448/sun-pharma-announces-licensing-agreement-with-csir-iict.html Wed, 14 Aug 2019 12:55:00 +0530 Sun Pharmaceutical Industries Ltd. has entered into a global licensing agreement with the CSIR Indian Institute of Chemical Technology, Hyderabad (CSIR-IICT), for patents related to certain compounds with potential therapeutic activity across multiple indications in Sun Pharma’s specialty focus areas. Under the terms of the license agreement, Sun Pharma gets exclusive global license for the said patents and any other future patents covered in the agreement. Sun Pharma will pay CSIR-IICT upfront and potential development, regulatory and sales milestone payments totaling up to Rs.2.40 billion, plus royalties on net sales from commercialization of the products developed using these patents. Sun Pharma will be responsible for development, regulatory filings, manufacturing and commercialization of these potential products. Dilip Shanghvi, Managing Director, Sun Pharma said, “This collaboration with CSIR-IICT for developing new drugs is part of our broader strategy for enhancing our global specialty pipeline. CSIR-IICT is well-known for its high quality research and we are proud to be associated with them. We are making earnest efforts to bring innovations from Indian research institutes to the market to address the unmet needs of patients globally. Our collaboration with CSIR-IICT is a step in this direction.” This agreement will facilitate addition of pre-clinical candidates to Sun Pharma’s global specialty pipeline. A successful clinical development of these potential compounds may enable Sun Pharma to commercialize pharmaceutical products for various therapeutic indications over the long term. ]]> <![CDATA[Abbott to showcase technologies overcoming health challenges ]]> https://biospectrumindia.com/news/95/14446/abbott-to-showcase-technologies-overcoming-health-challenges-.html https://biospectrumindia.com/news/95/14446/abbott-to-showcase-technologies-overcoming-health-challenges-.html Wed, 14 Aug 2019 11:20:00 +0530 Abbott builds on the success of its “Real Heroes campaign,” which was shortlisted for a Cannes Lion award, with new advertisements that demonstrate how our life-changing technology can enable people to move beyond their health challenges and pursue all that inspires them. The campaign articulates the thought, ‘the most personal technology is the technology with the power to change your life.’ While health conditions may be seen to limit a person’s capabilities and begin to define them, innovative new medical technologies from Abbott can help empower people with the data and knowledge they need to live longer and better.   Commenting on the campaign, Vivek Mohan, divisional vice president, corporate global marketing, Abbott said, “Abbott has always been at the forefront of innovation. For us, it has been about celebrating the unstoppable spirit of people and inspiring them to discover the possibilities that good health can bring. We are shaping the future of healthcare in India with leading technologies, products and services. This year, we are showcasing the ways in which we help touch the lives of people through these technologies to live healthier, better and fuller lives." The campaign is now live on major digital platforms and broadcast channels. The television commercial (TVC) portrays how one such technology, the insertable cardiac monitor, enables people to stay directly connected to their doctor no matter where they are or what they’re doing e.g. biking, swimming, and even piloting a plane. This product is a paperclip-sized implantable device that combines smartphone connectivity and continuous, remote monitoring to track unpredictable heart rhythm problems for fast and accurate diagnosis. It helps physicians make quicker decisions on their patients’ health in ways that fit into their lives. This is a contrast to the old way of diagnosing cardiac arrhythmias, in which detecting cardiac conditions required intermittent visits to the clinic or hospital to have wires and monitors connected to examine their hearts. The TVC will be followed by a series of video and editorial content that speaks to other such technologies and how they have impacted people.     ]]> <![CDATA[Alembic pharma receives USFDA approval for two new drugs]]> https://biospectrumindia.com/news/95/14439/alembic-pharma-receives-usfda-approval-for-two-new-drugs.html https://biospectrumindia.com/news/95/14439/alembic-pharma-receives-usfda-approval-for-two-new-drugs.html Tue, 13 Aug 2019 15:10:00 +0530 Gujarat based Alembic Pharmaceuticals Limited has announced that the Company has received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Fenofibrate Tablets USP, 48 mg and 145 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Tricor Tablets, 48 mg and 145 mg, of AbbVie Inc. (AbbVie). Fenofibrate Tablets, USP are indicated as adjunctive therapy to diet to reduce elevated low-density lipoprotein cholesterol (LDL-C), total cholesterol (Total-C), Triglycerides and apolipoprotein B (Apo B), and to increase high-density lipoprotein cholesterol (HDLC) in adult patients with primary hypercholesterolernla or mixed dyslipidemia. It is also indicated as adjunctive therapy to diet for treatment of adult patients with severe hypertriglyceridemia. Improving glycemic control in diabetic patients showing fasting chylomicronemia will usually obviate the need for pharmacologic intervention. Markedly elevated levels of serum triglycerides (e.g. > 2,000 mg/dl) may increase the risk of developing pancreatitis. The effect of fenofibrate therapy on reducing this risk has not been adequately studied. The company has also announced approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) for Dorzolamide Hydrochloride Ophthalmic Solution USP, 2%. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Trusopt Ophthalmic Solution, 2%, of Merck Sharp & Dohme Corp. Dorzolamide Hydrochloride Ophthalmic Solution is a carbonic anhydrase inhibitor indicated in the treatment of elevated intraocular pressure in patients with ocular hypertension or open-angle glaucoma.  ]]> <![CDATA[Erba introduces new product at AACC 2019]]> https://biospectrumindia.com/news/95/14429/erba-introduces-new-product-at-aacc-2019.html https://biospectrumindia.com/news/95/14429/erba-introduces-new-product-at-aacc-2019.html Mon, 12 Aug 2019 17:15:00 +0530 Erba Mannheim, a leading global In-vitro Diagnostic Company and a part of the global Transasia-Erba group, recently participated in the 71st Annual Scientific Meeting of AACC (American Association of Clinical Chemistry). In addition to showcasing their latest, high quality, affordable IVD solutions in Hematology, Clinical Chemistry, Urinalysis and Immunoassay, the Erba group also introduced NEXUS, its advanced automation range. Aimed at delivering mid-scale, advanced automation across immunology, clinical chemistry and hematology, the Erba NEXUS range employs advanced technology including AI-based blood cell image analysis, advanced CLIA magnetic beads, thick film ISE analysis and an intuitive sample transport system to deliver affordable modular automation. “Mid-sized labs need to streamline workflow, optimise space usage and accelerate turn-around time (TAT) with high result quality to keep their operations viable. But the challenge that they face, is that they are either too small for big automated systems, or too big to keep adding stand-alone auto-samplers. We developed the NEXUS range to fill this gap, giving mid-scale labs access to advanced modular automation. It offers technology specifically designed to improve workflow with high analytical test quality at an affordable price,” said Alastair McLeod, Vice President Global Marketing, Erba group. Nikhil Vazirani, Managing Director, Erba group further added, “NEXUS is an exciting development based on years of close customer feedback. Our vision is to make total lab automation more common in emerging markets and allow the average mid-sized lab to offer higher quality diagnostics to millions of underserved patients.” Besides unveiling NEXUS, the Erba Group showcased some other products such as, XL 200 and XL 640, clinical chemistry analyzers now upgraded to include a touch screen with improved software for easier operation, longer walk-away time and faster TAT. Elan 30s, a fully automated compact benchtop ELISA microstrip processor was also showcased. Elan 30s can perform 6 different tests simultaneously. Not just the analyzers, the Erba group also introduced the new Erba LIMS software with mobile app providing high function device interfacing and remote online approval of patient reports, eliminating need for expensive LIS systems. Along with new products, the existing suite of Erba solutions was also featured, including the LAURA XL, fully automatic urine analyzer and the H560 and ELITE 580, fully automatic hematology analyzers. The product display was supported by four on-booth insightful sessions by Erba’s team of product experts. Varied topics on AI enabling urine analyzers to achieve efficiency of sample processing, choosing the appropriate lab method for ovarian reserve test, assessing the performance of biomarkers for clinical chemistry analyzers, and affordability of LIMS software apps to add flexibility, quality and speed to data management were covered. Erba is a part of the global Transasia-Erba group founded by Mr. Suresh Vazirani in India, and with operations in Europe and the US. It serves millions across 100 countries. Transasia-Erba group is India's No. 1 In-vitro Diagnostic (IVD) company and among the leading global IVD players focused on emerging markets. At present, there are just three companies in the world who can offer complete range of products to a clinical lab. The Transasia-Erba group is working to become the fourth company in the world to offer a complete line of IVD products. ]]> <![CDATA[USFDA completes audit of Dr Reddy's US based plant]]> https://biospectrumindia.com/news/95/14425/usfda-completes-audit-of-dr-reddys-us-based-plant.html https://biospectrumindia.com/news/95/14425/usfda-completes-audit-of-dr-reddys-us-based-plant.html Mon, 12 Aug 2019 12:35:00 +0530 Dr Reddys Laboratories Ltd. is an integrated pharmaceutical company, committed to providing affordable and innovative medicines for healthier lives. The company offers a portfolio of products and services including APIs, custom pharmaceutical services, generics, biosimilars and differentiated formulations. Dr Reddys operates in markets across the globe. Dr Reddy's Laboratories said that the US health regulator has completed audit of its Louisiana-based formulations manufacturing facility, following which no form 483 was issued. The audit of our formulations manufacturing facility at Shreveport, Louisiana, USA by the the US Food and Drug Administration (USFDA), has been completed on August 8, 2019.  As per the USFDA, a Form 483 is issued to a firm's management at the conclusion of an inspection when investigator has observed any conditions that in its judgment may constitute violations of the Food Drug and Cosmetic Act and related Acts. ]]> <![CDATA[Cadila Pharma bags TISS LeapVault CLO awards in two categories]]> https://biospectrumindia.com/news/95/14416/cadila-pharma-bags-tiss-leapvault-clo-awards-in-two-categories.html https://biospectrumindia.com/news/95/14416/cadila-pharma-bags-tiss-leapvault-clo-awards-in-two-categories.html Fri, 09 Aug 2019 16:25:00 +0530 Cadila Pharmaceuticals bagged two TISS LeapVault CLO awards under the categories of ‘Program for Sales Enablement’ and ‘Social Media Based Learning Program’. Tata Institute of Social Science-Leapvault CLO Summit and Award is a prestigious event, which brings together leaders from human resource, corporate learning, coaching, organization, and leadership development. This award was conferred on the Learning and Development (L&D) team of Cadila Pharma for their initiative of training the field force using WhatsApp. When the world is trying to build specialized apps for specific functions, Cadila’s L&D team thought of an idea of using the existing platform of Whatsapp to increase their reach. Hence, the team merged e-learning with social media for the training of the field force. The L&D team of Cadila Pharmaceuticals began its training program in January 2019. The objective of the training is to build customer-centric capabilities of its diversified field force using new-age learning tools. The company adopted a mix of classroom teaching and e-learning using WhatsApp as a tool to ensure the application of the key learnings. The L&D team trained 1,999 employees across 13 locations in ten days. For the remainder of the training program, the team used WhatsApp to ensure a regular connect was maintained with the teams. Through innovative weekly campaigns of selfies, audio and video clips to ensure the application of the learning, which included grooming, interpersonal skills, and communication. Dr. Sunil Singh, the Chief Human Resource Officer of Cadila Pharmaceuticals and Mr. Ajay Tyagi, Chief Learning Officer of Cadila Pharma were the brains behind this creative solution. “We observed 30% adoption among our colleagues, which is higher than the standard 20-25% usually seen in e-learning. This initiative is one more step towards our vision of becoming a progressive, transformative and a caring organization.” Dr Singh said in a statement. This recognition comes recently after two awards won by Cadila Pharmaceuticals for the “Best Warehouse Workforce Award” at the Second Annual Future Warehouse Summit Awards 2019 in the month of July 2019 and a WorldStar Packaging Award in May 2019. Cadila Pharma has been making bold moves to ensure a culture of excellence. With multiple initiatives like four-day summer break, leave on first Saturdays and Flexi timings, Cadila Pharma has remained committed towards breaking the age-old practices of the manufacturing industry. Cadila Pharmaceuticals Ltd. is one of the largest privately-held pharmaceutical companies. Over the past six decades, we have been developing and manufacturing affordable medicines for patients around the world. Its innovation-led drug discovery processes ensure the health and well-being of people around the world. Being a care-focused, research-driven company, we are committed to complying with the highest ethical standard in clinical research and medical practice. ]]> <![CDATA[Cadila Pharma bags TISS LeapVault CLO awards in two categories]]> https://biospectrumindia.com/news/95/14415/cadila-pharma-bags-tiss-leapvault-clo-awards-in-two-categories.html https://biospectrumindia.com/news/95/14415/cadila-pharma-bags-tiss-leapvault-clo-awards-in-two-categories.html Fri, 09 Aug 2019 16:20:00 +0530 Cadila Pharmaceuticals bagged two TISS LeapVault CLO awards under the categories of ‘Program for Sales Enablement’ and ‘Social Media Based Learning Program’. Tata Institute of Social Science-Leapvault CLO Summit and Award is a prestigious event, which brings together leaders from human resource, corporate learning, coaching, organisation and leadership development. This award was conferred on the Learning and Development (L&D) team of Cadila Pharma for their initiative of training the field force using WhatsApp.  When the world is trying to build specialized apps for specific functions, Cadila’s L&D team thought of an idea of using the existing platform of Whatsapp to increase their reach. Hence, the team merged e-learning with social media for the training of the field force. The L&D team of Cadila Pharmaceuticals began its training program in January 2019. The objective of the training is to build customer-centric capabilities of its diversified field force using new-age learning tools. The company adopted a mix of classroom teaching and e-learning using WhatsApp as a tool to ensure the application of the key learnings. The L&D team trained 1,999 employees across 13 locations in ten days. For the remainder of the training program, the team used WhatsApp to ensure a regular connect was maintained with the teams. Through innovative weekly campaigns of selfies, audio and video clips to ensure the application of the learning, which included grooming, interpersonal skills, and communication.  Dr. Sunil Singh, the Chief Human Resource Officer of Cadila Pharmaceuticals and Mr. Ajay Tyagi, Chief Learning Officer of Cadila Pharma were the brains behind this creative solution. “We observed 30% adoption among our colleagues, which is higher than the standard 20-25% usually seen in e-learning. This initiative is one more step towards our vision of becoming a progressive, transformative and a caring organization.” Dr Singh said in a statement. This recognition comes recently after two awards won by Cadila Pharmaceuticals for the “Best Warehouse Workforce Award” at the Second Annual Future Warehouse Summit Awards 2019 in the month of July 2019 and a WorldStar Packaging Award in May 2019.  Cadila Pharma has been making bold moves to ensure a culture of excellence. With multiple initiatives like four-day summer break, leave on first Saturdays and flexi timings, Cadila Pharma has remained committed towards breaking the age-old practices of manufacturing industry. ]]> <![CDATA[Eversana expands APAC business with new office in Mumbai]]> https://biospectrumindia.com/news/95/14391/eversana-expands-apac-business-with-new-office-in-mumbai.html https://biospectrumindia.com/news/95/14391/eversana-expands-apac-business-with-new-office-in-mumbai.html Wed, 07 Aug 2019 11:20:00 +0530 EVERSANA, the leading independent provider of global commercial services to the life science industry, has announced the rapid expansion of its Asia Pacific business with the addition of two new offices in Singapore and Mumbai. The announcement comes as the company appoints a regional leadership team which will be based in Singapore to drive the company's growth and ensure client service. EVERSANA offers a fully integrated and independent commercial services platform designed to solve patient support, distribution, field force, compliance and marketing challenges in the life science sector. As the Asia Pacific market grows, there is an increased need for global solution capabilities for companies headquartered in the area or aiming to expand in the region, as well as US and European headquartered companies looking to bring solutions to the APAC markets. Worldwide, EVERSANA has more than 2,000 employees working from 25 locations, including offices in North America, Europe and Asia. EVERSANA plans to invest significant capital resources to build its regional footprint and support talent development. The company expects to open offices in Shanghai and Tokyo by the end of 2019. ]]> <![CDATA[Sai Life Sciences adopts ProcessMAP platform]]> https://biospectrumindia.com/news/95/14389/sai-life-sciences-adopts-processmap-platform.html https://biospectrumindia.com/news/95/14389/sai-life-sciences-adopts-processmap-platform.html Wed, 07 Aug 2019 11:15:00 +0530 ProcessMAP Corporation, the industry leader in cloud-based data intelligence platform for Environmental Health and Safety and Quality (EHSQ) announced that Sai Life Sciences Ltd. has adopted ProcessMAP’s platform enterprise-wide to support strategic initiatives in its Health, Safety, and Environmental sustainability (HSE) programs. Hyderebad Sai Life Sciences is a leading pharmaceutical services company that delivers advanced discovery, contract development and manufacturing solutions to about 7 out of the top 10 innovator pharmaceutical companies, apart from several small and medium sized biotech companies. ProcessMAP’s EHSQ platform will support Sai Life Sciences achieve several key HSE objectives, including: ● Establish consistency across various HSE processes ● Improve reporting, investigation and corrective actions or preventive actions (CAPAs) management throughout incident life cycle ● Provide actionable insight to reduce injuries and illnesses ● Enable compliance management via task and action item management ● Facilitate collection and aggregation of sustainability metrics, and public reporting of corporate social responsibility (CSR) performance under the GRI G4 framework ● Help the organization accelerate initiatives to build safety as an operational culture   “We required a comprehensive EHSQ platform that complements our robust internal programs and help us move from manual processes to next generation digital capabilities," said Ch. Sree Krishna, VP & Head EHSS at Sai Life Sciences Ltd. ]]> <![CDATA[Natco Pharma gets USFDA EIR for Telangana plant]]> https://biospectrumindia.com/news/95/14385/natco-pharma-gets-usfda-eir-for-telangana-plant.html https://biospectrumindia.com/news/95/14385/natco-pharma-gets-usfda-eir-for-telangana-plant.html Tue, 06 Aug 2019 18:40:00 +0530 Natco Pharma Limited is pleased to announce successful closure of inspection with the receipt of Establishment Inspection Report (EIR) from the U.S. Food and Drug Administration (FDA) for the inspection conducted at its drug formulations facility in Kothur Village, Telangana, India, during the period May 30th – June 5th, 2019. Natco Pharma Limited was incorporated in Hyderabad in the year 1981. With a modest beginning of operations as a single unit with 20 employees, Natco has seven manufacturing facilities spread across India with modern research laboratories, capabilities in new drug development, etc.  Natco, currently consists of around 5,000 employees and is consistently ranked among fastest growing pharmaceutical companies in India and is well recognized for its innovation in pharmaceutical research and development. In FY 2018-19, NATCO recorded consolidated total revenue of INR 22,247 million as against INR 22,424 million for the last year. The net profit for the period, on a consolidated basis, was INR 6,444 million, as against INR 6,962 million last year. ]]> <![CDATA[Cadila Pharma accredited as authorized economic operator]]> https://biospectrumindia.com/news/95/14378/cadila-pharma-accredited-as-authorized-economic-operator.html https://biospectrumindia.com/news/95/14378/cadila-pharma-accredited-as-authorized-economic-operator.html Tue, 06 Aug 2019 11:15:00 +0530 Adding another feat to their success story, the pharmaceutical major Cadila Pharmaceuticals was recognized as an Authorized Economic Operator (AEO) by The Central Board of Indirect Taxes and Customs, which functions under the Ministry of Finance. “In recognition and appreciation of your commitment to secure the international supply chain and in compliance with the WCO’s SAFE Framework of Standards, Indian Customs certifies your esteemed organization in the Authorized Economic Operator (AEO) program,” stated the accreditation dated July 26. The AEO aims to enhance international supply chain security and facilitate movement of legitimate goods. It enables Indian Customs to enhance and streamline cargo security through close operation with principle stakeholders such as importers, exporters, logistics providers, custodians or terminal operators, customs brokers, and warehouse operators. It is also aimed at promoting Ease of Doing Business and to emulate global best practices. On getting AEO accreditation Mr. K.V.R. Sarma, Vice President, Head Supply Chain said, “We have been making serious strides to strengthen our Supply Chain operations. We recently won the Best Warehouse Workforce award and now with AEO accreditation we can see our efforts paying off.” The AEO members are eligible for various benefits such as inclusion of direct port delivery of imports to ensure just-in-time inventory management by manufacturers, inclusion of direct port entry for factory stuffed containers meant for exports by AEOs, faster disbursal of drawback amount, priority processing of assessment/examination, faster disbursal of refund, automatic activation of deferred duty payment option, among others. Cadila Pharmaceuticals Ltd. is one of the largest privately held pharmaceutical companies. Over the past six decades, we have been developing and manufacturing affordable medicines for patients around the world. Its innovation-led drug discovery processes ensure the health and well-being of people around the world. Being a care-focused, research-driven company, we are committed to complying with the highest ethical standard in clinical research and medical practice.   ]]> <![CDATA[Lupin’s Aurangabad facility receives EIR from the USFDA]]> https://biospectrumindia.com/news/95/14376/lupins-aurangabad-facility-receives-eir-from-the-usfda.html https://biospectrumindia.com/news/95/14376/lupins-aurangabad-facility-receives-eir-from-the-usfda.html Mon, 05 Aug 2019 17:55:00 +0530 Pharma major Lupin Limited (Lupin) has announced the receipt of the Establishment Inspection Report (EIR) from the U.S. FDA for its Aurangabad facility. The facility was inspected by the U.S. FDA between May 6, 2019 and May 15, 2019.   Lupin’s Aurangabad facility is involved in the manufacture of Oral Solid Dosage, Oral Liquid and Powder for Oral Suspension products for the US Market, WHO/Global Institution markets and the India market. Commenting on the development, Nilesh Gupta, Managing Director, Lupin said, “Lupin is committed to adherenceand full compliance with cGMP regulations and all other applicable regulatory requirements at our manufacturing sites. We are very happy to receive the EIR for our Aurangabad facility marking the satisfactory closure of the US FDA inspection.” ]]> <![CDATA[Zydus completes phase III trial of diabetes drug in India]]> https://biospectrumindia.com/news/95/14374/zydus-completes-phase-iii-trial-of-diabetes-drug-in-india.html https://biospectrumindia.com/news/95/14374/zydus-completes-phase-iii-trial-of-diabetes-drug-in-india.html Mon, 05 Aug 2019 17:30:00 +0530 Zydus Cadila, an innovation-driven, global pharmaceutical company, announced that it has completed Phase 3 Clinical Trial in India of Saroglitazar Mg for treating Type 2 Diabetes. The trial was a multi-centric, randomized, double blind study to evaluate the safety and efficacy of 2mg and 4mg of Saroglitazar compared to Pioglitazone 45mg in patients with Type 2 Diabetes Mellitus. The Phase 3 trial enrolled 1140 subjects and studied the patients over a period of 56 weeks. The primary outcome of the trial was a change from baseline in glycosylated haemoglobin (HbA1c) for Saroglitazar 4 mg, 2 mg and Pioglitazone 30 mg at 24 weeks. The study also measured glycosylated haemoglobin (HbA1c) and other secondary outcome measures including fasting plasma glucose, Triglyceride (TG) cholesterol, Low Density Lipoprotein (LDL) cholesterol, Very Low Density Lipoprotein (VLDL) cholesterol, High Density Lipoprotein (HDL) cholesterol, Total Cholesterol (TC) cholesterol, Non HDL cholesterol, Apolipoprotein (Apo) A1, Apo B between Saroglitazar 4 mg, 2 mg and Pioglitazone 30 mg at Week 12, Week 24, and Week 56. The Phase 3 trial has demonstrated efficacy and achieved statistical significance for its primary endpoint which was the change in mean HbA1c as compared to the baseline. No severe hypoglycaemia events were reported. There was no weight gain or edema observed with Saroglitazar Mg. “Insulin resistance is the root cause of Type 2 Diabetes Mellitus and the data from this trial reveals that Saroglitazar Mg, a next-generation Insulin Sensitizer without the edema and weight gain sideeffects, could emerge as a potent anti-diabetic agent for millions of patients suffering from Type-2 Diabetes.” said Pankaj R. Patel, Chairman, Zydus group. Saroglitazar Magnesium was launched in India during September 2013 under the brand name ‘Lipaglyn’, for the treatment of hypertriglyceridemia and diabetic dyslipidemia in patients with Type-2 diabetes not controlled by statins. ]]> <![CDATA[GSK completes transaction with Pfizer to form new Consumer Healthcare JV]]> https://biospectrumindia.com/news/95/14358/gsk-completes-transaction-with-pfizer-to-form-new-consumer-healthcare-jv.html https://biospectrumindia.com/news/95/14358/gsk-completes-transaction-with-pfizer-to-form-new-consumer-healthcare-jv.html Fri, 02 Aug 2019 10:55:00 +0530 GlaxoSmithKline plc has announced that it has completed its transaction with Pfizer to combine their consumer healthcare businesses into a world-leading Joint Venture. The Joint Venture brings together two highly complementary portfolios of consumer health brands, including GSK’s Sensodyne, Voltaren and Panadol and Pfizer’s Advil, Centrum and Caltrate. The Joint Venture will focus on completing the integration of the two businesses, which is expected to realise annual cost savings of £0.5bn by 2022 for expected total cash costs of £0.9 billion and non-cash charges of £0.3 billion. Up to 25% of the cost savings are intended to be reinvested in the business to support innovation and other growth opportunities. Brian McNamara, Chief Executive Officer, GSK Consumer Healthcare said, “Now the deal has closed, our focus will be on completing the integration of these two businesses and leveraging their combined strength. With our portfolio of brilliant, science-based brands and strong talent and capabilities, we are well-positioned to create a world-leading consumer healthcare business with stronger sales, cash flow and contribution to earnings.” Emma Walmsley, Chief Executive Officer, GSK and Chair of the Joint Venture said, “The completion of the joint venture with Pfizer marks the beginning of the next phase of our transformation of GSK. This is an important moment for the Group, laying the foundation for two great companies, one in Pharmaceuticals and Vaccines and one in Consumer Health.” As previously announced, GSK intends to demerge the Joint Venture from the company within three years and to list the GSK Consumer Healthcare business on the UK equity market.   ]]> <![CDATA[Biocon, Mylan launch first Trastuzumab Biosimilar Ogivri in Australia]]> https://biospectrumindia.com/news/95/14352/biocon-mylan-launch-first-trastuzumab-biosimilar-ogivri-in-australia.html https://biospectrumindia.com/news/95/14352/biocon-mylan-launch-first-trastuzumab-biosimilar-ogivri-in-australia.html Thu, 01 Aug 2019 15:40:00 +0530 Biocon Ltd. and Mylan N.V. have announced the launch in Australia of Ogivri™ (trastuzumab), a biosimilar to Herceptin®1 (trastuzumab), for the treatment of HER2-overexpressing breast cancer and metastatic stomach cancer (gastric or gastroesophageal junction adenocarcinoma). Ogivri is the first trastuzumab biosimilar approved and launched in Australia and available on the Pharmaceutical Benefits Scheme (PBS). Biosimilars generate savings that help manage the growing costs of Australia’s health care system, particularly the PBS. They enable greater patients access to necessary treatments and free up funding for the listing of the latest treatments. The Government recognises the importance of driving biosimilar uptake to create a competitive and sustainable biosimilars market. In 2015, the Government committed to the Biosimilar Awareness Initiative and in 2018 increased its commitment by supporting the Generic and Biosimilar Medicines Association through a $5 million grant to undertake activities that further promote the appropriate prescribing, dispensing and use of biosimilar medicines. Biosimilars have been used safely and effectively in Europe, USA, Australia and many other countries. Since 2006, in the EU alone, over 700 million patient days of exposure to more than 20 biosimilar medicines have been recorded2,3,4,5. TGA approval of Ogivri was based on robust data that demonstrated that Ogivri is highly similar to Herceptin with no clinically meaningful differences in efficacy, safety, purity and potency. One of the comparative studies, the HERITAGE study - published in the Journal of the American Medical Association (Rugo H. et al, JAMA, 2017; 317;1:37-47) -  involved 500 patients with HER2 positive metastatic breast cancer from 95 participating sites around the world. It found patient response to the two treatments to be equivalent in terms of reduction in tumour size at 24 weeks and overall survival at 48 weeks. Dr Christiane Hamacher, CEO, Biocon Biologics said, “We are extremely excited to enable access to Ogivri, in Australia, a high quality biosimilar trastuzumab, co-developed and manufactured by Biocon. Thousands of patients in Europe, India, and key emerging markets are benefitting from our biosimilar trastuzumab. Commercialisation of Ogivri by Mylan, in Australia, extends the global footprint of our biosimilar trastuzumab. We remain committed to transforming healthcare globally, by addressing patient needs through our high quality, affordable biologics.” Mylan Australia Country Manager, Sylvain Vigneault commented, "As a global leader in the development of complex products, including biosimilar medicines, we're pleased to launch our first biosimilar in Australia. Biosimilars increase timely and affordable patient access to the latest treatments and help deliver a sustainable PBS. Mylan's investment in biosimilars is an exciting evolution in how we can treat Australian patients. We are delighted that Ogivri enables Mylan, with our partner Biocon, to bring this treatment option to Australian patients with HER2-positive breast and gastric cancers.” Mylan and Biocon's trastuzumab biosimilar is currently approved in more than 65 countries around the world, including the U.S.  ]]> <![CDATA[Sun Pharma announces regulatory filing of Tildrakizumab in Japan ]]> https://biospectrumindia.com/news/95/14351/sun-pharma-announces-regulatory-filing-of-tildrakizumab-in-japan-.html https://biospectrumindia.com/news/95/14351/sun-pharma-announces-regulatory-filing-of-tildrakizumab-in-japan-.html Thu, 01 Aug 2019 14:05:00 +0530 Sun Pharmaceutical Industries Ltd. has announced that one of its wholly owned subsidiaries has filed an application for Manufacturing and Marketing Authorization of Tildrakizumab for moderate-to-severe psoriasis and psoriatic arthritis with the Pharmaceuticals and Medical Devices Agency (PMDA), Japan.  Kirti Ganorkar, EVP & Head Global Business Development, Sun Pharma said, “Sun Pharma is committed to growing its global dermatology franchise, with Tildrakizumab as its lead product. We continue to build our pipeline and capabilities in this important therapeutic area of significant unmet need. This filing in Japan is a step forward for Sun Pharma in expanding the global franchise for the product. It offers a potential new treatment option to patients who struggle everyday with the chronic nature of these aliments.” The recent acquisition of Pola Pharma (Pola) in Japan will help Sun Pharma leverage Pola’s strong presence in the dermatology segment to commercialize Tildrakizumab post regulatory approval. Sun Pharma had announced the closure of the Pola acquisition in January 2019. ]]> <![CDATA[Mylan and Pfizer collaborate to form new global medicine biz]]> https://biospectrumindia.com/news/95/14342/mylan-and-pfizer-collaborate-to-form-new-global-medicine-biz.html https://biospectrumindia.com/news/95/14342/mylan-and-pfizer-collaborate-to-form-new-global-medicine-biz.html Wed, 31 Jul 2019 14:50:00 +0530 Mylan N.V. and Pfizer Inc. have announced a definitive agreement to combine Mylan with Upjohn, Pfizer’s off-patent branded and generic established medicines business, creating a new global pharmaceutical company. Under the terms of the agreement, which is structured as an all-stock, Reverse Morris Trust transaction, each Mylan share would be converted into one share of the new company. Pfizer shareholders would own 57% of the combined new company, and Mylan shareholders would own 43%. The Boards of Directors of both Mylan and Pfizer have unanimously approved the transaction. The new company will transform and accelerate each businesses’ ability to serve patients’ needs and expand their capabilities across more than 165 markets by bringing together 2 two highly complementary businesses. Mylan brings a diverse portfolio across many geographies and key therapeutic areas, such as central nervous system and anesthesia, infectious disease and cardiovascular, as well as a robust pipeline, high-quality manufacturing and supply chain excellence. Upjohn brings trusted, iconic brands, such as Lipitor (atorvastatin calcium), Celebrex (celecoxib) and Viagra (sildenafil), and proven commercialization capabilities, including leadership positions in China and other emerging markets. The transaction will allow the new company to meaningfully expand the geographic reach of Mylan’s existing broad product portfolio and future pipeline – including significant investments that have been made across complex generics and biosimilars – into new growth markets where Upjohn has existing sales infrastructure and local market expertise. The combination will drive a sustainable, diverse and differentiated portfolio of prescription medicines, complex generics, over-the-counter products and biosimilars supported by commercial and regulatory expertise, established infrastructure, best-in-class R&D capabilities and high-quality manufacturing and supply chain excellence. ]]> <![CDATA[J Mitra receives recognition at Global Healthcare Excellence Awards 2019]]> https://biospectrumindia.com/news/95/14339/j-mitra-receives-recognition-at-global-healthcare-excellence-awards-2019.html https://biospectrumindia.com/news/95/14339/j-mitra-receives-recognition-at-global-healthcare-excellence-awards-2019.html Wed, 31 Jul 2019 11:35:00 +0530 India’s leading in-vitro diagnostics company, J Mitra & Co has been awarded for Innovation & Research in Healthcare at the 7th Global Healthcare Excellence Awards 2019 held in Delhi. This prestigious award was given out to J Mitra & Co by the Minister of State for Health and Family Welfare Ashwini Kr Choubey.J Mitra & Co is a research-based biotechnology company that has been driving innovation in the healthcare (diagnostics) space since 1969. With over 55 patents to its credit which is the highest in its segment, J Mitra and Co has been constantly innovating to bring cost effective potent solutions for the global healthcare industry.J Mitra’s latest innovation is India’s first portable diagnostic solution - the iQuant immunoassay analyzer. Launched in collaboration with IIT Madras’ HTIC (Healthcare Technology Innovation Centre), this portable state-of-the-art Fluorescence Immunoassay Analyzer provides quantitative and qualitative determination of blood test parameter – that includes TSH (Thyroid Stimulating Hormone), T3 (Tri-iodo thyronine), T4 (Thyroxin), Vitamin D, Dengue NS1 Antigen, Dengue IgM, Dengue IgG and HbA1c test. With this innovation, various highly-active and sought-after diagnostic solutions are now available across the country and in the remotest of locations at the fraction of a cost.Speaking on the occasion, Jatin Mahajan, managing director, J Mitra said, “Innovation is the cornerstone of everything that we do at this company. We believe in launching innovative, path-breaking products that greatly influence the detection and diagnostic process, which hasten the treatment and cure process – resulting in a healthier India, in line with government’s healthcare-for-all initiative.”This is a home-grown innovative solution – a “completely Made-in-India” offering. While being the most cost-effective solution available in the market today, what sets it apart is the fact that it is completely portable. It can be carried with ease and has a self-sustaining power supply. It is thus quite suited for Indian conditions, especially for remote and electricity-dark areas. ]]> <![CDATA[Biological E, GVK BIO announce strategic R&D partnership]]> https://biospectrumindia.com/news/95/14336/biological-e-gvk-bio-announce-strategic-rd-partnership.html https://biospectrumindia.com/news/95/14336/biological-e-gvk-bio-announce-strategic-rd-partnership.html Wed, 31 Jul 2019 11:10:00 +0530 GVK BIO, a leading global Contract Research and Development Organisation (CRDO), and BE Pharmaceuticals Inc (BE Inc), a rapidly growing pharmaceutical company that develops, manufactures and markets complex and critical injectable products, have announced a strategic collaboration in drug product development. BE Pharmaceuticals Inc is a subsidiary of Biological E. Limited and focuses on Speciality Generic Injectables. As part of the partnership, GVK BIO will develop certain set of injectable products for BE Inc.  Development work will include Pre-Formulation studies, Formulation Development, Analytical Method Development and Technology Transfer to a BE facility. The goal of the collaboration will be the successful regulatory submissions and marketing authorizations for the products in the US, Europe and RoW markets.  “GVK BIO’s Formulations Development team has the technical expertise and track record to deliver on projects, and we look forward to working with the BE team to accelerate product development timelines and reduce cost to market,” said Manni Kantipudi, Director & Chief Executive Officer, GVK BIO.  “We are excited to work with GVK BIO, an established CRDO,” said Narender Mantena, CEO, Speciality Generic Injectable, BE Pharmaceuticals. “This collaboration will support BE in building a robust pipeline, especially for critical injectable products.”   ]]> <![CDATA[Dr. Reddy's launches Pregabalin capsules in the U.S. Market]]> https://biospectrumindia.com/news/95/14331/dr-reddys-launches-pregabalin-capsules-in-the-u-s-market.html https://biospectrumindia.com/news/95/14331/dr-reddys-launches-pregabalin-capsules-in-the-u-s-market.html Tue, 30 Jul 2019 15:30:00 +0530 Dr. Reddy’s Laboratories Ltd., has announced the launch of Pregabalin Capsules a therapeutic equivalent generic version of Lyrica® (pregabalin) Capsules approved by the U.S. Food and Drug Administration (USFDA).   The Lyrica® (pregabalin) Capsules brand had U.S. sales of approximately $5,462 million MAT for the most recent twelve months ending in May 2019 according to IQVIA Health.  Dr. Reddy’s Pregabalin Capsules are available in 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg and 300 mg capsules in bottle count sizes of 90. This is also a controlled substance schedule V product. Lyrica® is a trademark of C.P. PHARMACEUTICALS INTERNATIONAL C.V. ]]> <![CDATA[Strides forms JV with Sihuan Pharmaceutical in China]]> https://biospectrumindia.com/news/95/14330/strides-forms-jv-with-sihuan-pharmaceutical-in-china.html https://biospectrumindia.com/news/95/14330/strides-forms-jv-with-sihuan-pharmaceutical-in-china.html Tue, 30 Jul 2019 15:05:00 +0530 Strides Pharma Global Pte, Singapore (SPG), subsidiary of Strides Pharma Science Limited (Strides) has entered into a Joint Venture (JV) with Sun Moral International (HK) Limited, a wholly-owned subsidiary of Sihuan Pharmaceutical Holdings Group Ltd (Sihuan), one of China’s leading pharmaceutical companies. The JV fast tracks Strides’ entry into China,the second-largest pharmaceutical market in the World offering a $137 billion (IQVIA) market opportunity. Sihuan is one of the leading pharmaceutical companies in China’s prescription drug market with a market share of 8.3% in the cardio-cerebral vascular market and strong positioning in other therapeutic areas. The recent regulatory developments in China have enabled fast track approvals of differentiated highquality generics approved in key regulated markets. Strides’ specialized basket of 140+ products qualifies for the program, and this JV will be able to leverage it in China. Strides will immediately license four high potential products to the JV which will add significant value to Sihuan’s existing portfolio. Strides will supply these products to the JV from its manufacturing facilities at India and Singapore. The JV will explore setting up local manufacturing in China in due course. Sihuan will leverage its 4000+ strong salesforce and 3000+ distributors across Mainland China to market the products. ]]> <![CDATA[Mylan and Pfizer to create a new company ]]> https://biospectrumindia.com/news/95/14319/mylan-and-pfizer-to-create-a-new-company-.html https://biospectrumindia.com/news/95/14319/mylan-and-pfizer-to-create-a-new-company-.html Mon, 29 Jul 2019 18:05:00 +0530 Mylan and Pfizer Inc. has announced a definitive agreement to combine Mylan with Upjohn, Pfizer’s off-patent branded and generic established medicines business, creating a new global pharmaceutical company. Under the terms of the agreement, which is structured as an all-stock, Reverse Morris Trust transaction, each Mylan share would be converted into one share of the new company. Pfizer shareholders would own 57% of the combined new company, and Mylan shareholders would own 43%. The Boards of Directors of both Mylan and Pfizer have unanimously approved the transaction. The new company will transform and accelerate each businesses’ ability to serve patients’ needs and expand their capabilities across more than 165 markets by bringing together two highly complementary businesses. Mylan brings a diverse portfolio across many geographies and key therapeutic areas, such as central nervous system and anesthesia, infectious disease and cardiovascular, as well as a robust pipeline, high-quality manufacturing and supply chain excellence. Upjohn brings trusted, iconic brands, such as Lipitor (atorvastatin calcium), Celebrex (celecoxib) and Viagra (sildenafil), and proven commercialization capabilities, including leadership positions in China and other emerging markets. The transaction will allow the new company to meaningfully expand the geographic reach of Mylan’s existing broad product portfolio and future pipeline – including significant investments that have been made across complex generics and biosimilars – into new growth markets where Upjohn has existing sales infrastructure and local market expertise. The combination will drive a sustainable, diverse and differentiated portfolio of prescription medicines, complex generics, over-the-counter products and biosimilars supported by commercial and regulatory expertise, established infrastructure, best-in-class R&D capabilities and high-quality manufacturing and supply chain excellence. The new company is expected to have pro forma 2020 revenues1 of $19 to $20 billion. Pro forma 2020 adjusted EBITDA is anticipated to be in the range of $7.5 to $8.0 billion, including phased synergies of approximately $1 billion annually to be realized by 2023. Pro forma free cash flow for 2020 is expected to be more than $4 billion. The new company will be focused on returning capital to shareholders, while maintaining a solid investment grade credit rating. It expects to achieve a ratio of debt to adjusted EBITDA of 2.5x by the end of 2021. In addition, the new company intends to initiate a dividend of approximately 25% of free cash flow beginning the first full quarter after close and the potential for share repurchases once the debt to adjusted EBITDA target is sustained. The new company, which will be renamed and rebranded at close, will be led by Mylan’s current Chairman Robert J. Coury, who will serve as Executive Chairman of the new company; Michael Goettler, current Group President, Upjohn, who will serve as Chief Executive Officer (CEO); and Rajiv Malik, current Mylan President, who will serve as President. Ken Parks, currently CFO of Mylan, has agreed to depart the company at closing. Heather Bresch, Mylan’s current CEO, will retire from Mylan upon the close of this transaction. Robert J. Coury, Mylan Chairman, said, “Over the past year and a half, I have spent a lot of time speaking with and listening attentively to our shareholders. Today’s announcement builds upon many of those meaningful conversations and represents a transformative move for Mylan. The new company, which combines the unique assets of Mylan with the iconic brands of Pfizer’s Upjohn business, will not only accelerate our mission to serve the world’s changing health needs, but also further unlock the true value of our platform while delivering attractive returns to shareholders for many years to come. Importantly, the combined organization will have a presence across nearly every continent and major market, establishing a new leadership position in Asia, and offering products capable of treating all major therapeutic areas. This combination also further accelerates Mylan’s longstanding strategy to create the operational scale and commercial capabilities necessary to provide the world’s more than 7 billion people with access to medicine. As important, the transaction we are announcing today will enhance the strength of our balance sheet by scaling and increasing our existing strong cash flows, providing the new company with the financial flexibility to support and accelerate deleveraging and the expected initiation of a meaningful dividend from the first full quarter after the transaction closes. There will also be potential for share repurchases once the long-term leverage target is achieved. This powerful new profile positions the new company for sustained success and long-term value creation.” The Board of Directors of the new company will include its Executive Chairman and its CEO, as well as eight members designated by Mylan, and three members designated by Pfizer, for a total of thirteen members. The new company will be domiciled in the U.S. and incorporated in Delaware and will operate Global Centers in Pittsburgh, Pennsylvania; Shanghai, China, and Hyderabad, India. Dr. Albert Bourla, Pfizer CEO, stated, “We are creating a new champion for global health—one poised to bring world-class medicines to patients across a wide range of therapeutic areas. I believe that Mylan’s unique profile and strategy has made it the obvious partner of choice in creating this powerful combination. By bringing Mylan’s growth assets to Upjohn’s growth markets, we will create a financially strong company with true global reach. I’m also excited about the management team, which combines strong executive talent from both companies, whose commitment to improving global health for patients and to delivering returns to shareholders are great assets for the new company. For Pfizer, this transaction represents our sharpened focus on innovative medicines and is a testament to our purpose – breakthroughs that change patients’ lives. At the same time, we’ll maintain the financial flexibility to advance our strong pipeline, invest for growth and continue to return capital to our shareholders.” Coury continued: “The combination announced today also comes with Mylan CEO Heather Bresch’s decision to announce her intention to retire upon deal close after 27 years of distinguished service and leadership within Mylan. Heather has left a significant positive mark to the benefit of our company, patients and shareholders in so many ways including through her leadership and execution of our efforts to create a more sustainable Mylan. Her leadership helped to further position Mylan for this important milestone. Her presence and her impact will not only be missed by our Board of Directors, but also by our entire workforce of 35,000 across the world. We wish her much success with her future endeavors.” Heather Bresch, Mylan CEO said, “Mylan was founded nearly 60 years ago with the core purpose to provide access to medicine. Thanks to the hard work and dedication of thousands of Mylan employees and the transformative vision from leaders past and present, including Board Chair Robert J. Coury, Mylan has made significant strides toward providing that same access at a global level for the world’s 7 billion people. And now, the creation of this new company introduces a powerful expanded platform with the potential for patient impact that will be truly transformative and unique within the industry. Nearly eight years after becoming CEO, I’m proud to say that this milestone represents the culmination of the goals I set for myself when I challenged Mylan and our amazing workforce to set new standards in healthcare. And so, as the company prepares to set out on this exciting new journey under the next era of leadership, I too have decided to pursue a new chapter – one that will continue to be focused on serving people, patients and public health.” Coury continued: “Additionally, it is with great pleasure that I welcome Michael Goettler, a seasoned and high-quality pharma executive, as CEO of the new company. I am also pleased that Rajiv Malik will continue to serve in the role of president. Rajiv has been and continues to be instrumental in the building and execution of our true one-of-a-kind and very complex platform, and he will serve as a strong complementary partner to Michael. Lastly, I would like to thank Ken Parks for his leadership and service to Mylan, which has provided significant value to our company over the last three years, and know that he will continue to do so as we work toward a successful deal close.” Michael Goettler, Group President, Upjohn added: “I’m honored by the opportunity to lead this new company, which will deliver more medicines to more patients across the globe. I’m also excited to combine two talented and deeply experienced teams that share a passion for providing patients with access to medicines. I look forward to delivering on that shared commitment by combining Mylan’s broad and diverse portfolio with Upjohn’s iconic, trusted brands and bringing the Mylan growth products to the Upjohn growth markets. I share Robert’s commitment to leading this new company with a focus on total shareholder return and look forward to working with leaders at the company towards that end.” Mark Parrish, Chair of Mylan’s Strategic Review Committee, said: “This compelling combination concludes the work of Mylan’s Strategic Review Committee, which after our exhaustive review of available alternatives best positions the company to unlock value for our shareholders.” The combination will be effected through a Reverse Morris Trust, under which Upjohn is expected to be spun off or split off to Pfizer’s shareholders and simultaneously combined with Mylan. The transaction is expected to be tax free to Pfizer and Pfizer shareholders and taxable to Mylan shareholders. The transaction is anticipated to close in mid-2020, subject to approval by Mylan shareholders and customary closing conditions, including receipt of regulatory approvals. No vote is required by Pfizer shareholders. Upjohn will issue $12 billion of debt at or prior to separation, with gross debt proceeds retained by Pfizer. Upon closing, the new company is expected to have a solid investment grade credit rating. The new company will have approximately $24.5 billion of total debt outstanding at closing.   ]]> <![CDATA[Alvotech, Cipla Gulf to commercialize key Biosimilar in few emerging markets]]> https://biospectrumindia.com/news/95/14307/alvotech-cipla-gulf-to-commercialize-key-biosimilar-in-few-emerging-markets.html https://biospectrumindia.com/news/95/14307/alvotech-cipla-gulf-to-commercialize-key-biosimilar-in-few-emerging-markets.html Mon, 29 Jul 2019 09:35:00 +0530 Biopharmaceutical company Alvotech and Cipla Gulf FZ LLC, a wholly-owned subsidiary of the leading global pharmaceutical company Cipla Limited has announced that Alvotech and Cipla Gulf have entered into an exclusive partnership for the commercialization of AVT02, an adalimumab biosimilar, in select emerging markets. AVT02 is a mAb biosimilar to AbbVie’s HUMIRA®, which is a leading drug indicated for the treatment of several autoimmune diseases, including (but not limited to) Rheumatoid Arthritis (RA), Ankylosing Spondylitis (AS), Plaque Psoriasis (PP), Psoriatic Arthritis, Ulcerative Colitis (UC), and Crohn’s Disease (CD). It neutralizes the Tumor Necrosis Alpha (TNF-α) involved in systemic inflammation and the above-mentioned diseases. AbbVie’s HUMIRA® recorded sales of about US$20 billion in 2018, making it the largest-selling blockbuster medicine worldwide. Under the partnership, Alvotech will be responsible for development and supply of the product, while Cipla Gulf will be responsible for registration and commercialization. Alvotech’s AVT02 is in Phase-3 clinical development ahead of filing with the European Medicines Agency (EMA) and United States Food and Drug Administration (USFDA) by early 2020. Robert Wessman, Alvotech’s founder and Chairman said, “We are very proud to announce our strategic alliance with Cipla, a leading global company with over 84 years of history. By partnering with Cipla, Alvotech gains access to Cipla’s strong commercial network in select emerging markets and deep market experience, which will ultimately benefit patients who will get better access to high-quality biosimilars.” Nishant Saxena, CEO, International Business (Europe & Emerging Markets), Cipla, said: “This is a significant addition to our portfolio of offerings in the global biosimilars space which includes trastuzumab, bevacizumab, etanercept and pegfilgrastim. Adalimumab is the highest-selling pharmaceutical product in the world and the preferred anti-inflammatory treatment option for several autoimmune diseases. We look forward to partnering with Alvotech and leveraging our own strong commercial strengths and capabilities to make this highly effective treatment option available to patients in several countries.” Alvotech‘s initial pipeline contains several monoclonal-antibody and fusion-protein biosimilar candidates aimed at treating autoimmunity, oncology and inflammatory conditions to improve quality of life for patients around the world.   ]]> <![CDATA[Cipla USA furthers AMR stewardship with acquisition of key anti-infective ZEMDRI™ ]]> https://biospectrumindia.com/news/95/14286/cipla-usa-furthers-amr-stewardship-with-acquisition-of-key-anti-infective-zemdri-.html https://biospectrumindia.com/news/95/14286/cipla-usa-furthers-amr-stewardship-with-acquisition-of-key-anti-infective-zemdri-.html Thu, 25 Jul 2019 15:55:00 +0530 Cipla USA Inc. has announced the acquisition of the prescription drug ZEMDRI™ (Plazomicin) from Achaogen Inc. It has acquired worldwide rights of ZEMDRI™ (excluding Greater China) with its allied assets and limited liabilities.  ZEMDRI™ is a once-daily novel intravenous (IV) aminoglycoside for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis, in adults who are unresponsive to currently available treatment options. ZEMDRI™ was approved by the United States Food & Drug Administration (USFDA) in June 2018, and was launched in the same year, with patent protection expected to continue until 2031 or 2032. It has been granted a new technology add-on payment (NTAP) by the Centers for Medicare & Medicaid Services (CMS), for its administration in a hospital in-patient setting. The product has also been filed for approval in the European Union (EU). ZEMDRI™ is the latest milestone in Cipla’s history of proactive and humanitarian leadership in enabling access to life-saving drugs. In 2001, at the height of the global HIV movement, Cipla changed the treatment paradigm with its offer of a triple combination anti-retroviral therapy at less than a dollar a day in Africa against the prevailing price of around USD 12,000 a year for one patient. With anti-microbial resistance (AMR) today being an urgent global healthcare challenge, Cipla has been at the forefront of AMR stewardship. Plazomicin is a novel antibiotic effective against some of the cUTI-causing gram-negative bacteria that are resistant to beta-lactam antibiotics including carbapenems. Clinical studies have shown sustained microbiological eradication of the bacteria with Plazomicin.  Cipla is a signatory to the Industry Declaration on AMR at the World Economic Forum in Davos in 2016 that laid out a roadmap to combat AMR. An independent analysis released by the Access to Medicine Foundation in January 2018 identified Cipla as one of the drug-makers leading the effort to curb overuse of antibiotics, and implement production and source systems that help prevent environmental release of antibiotics. Umang Vohra, Managing Director and Global Chief Executive Officer, Cipla, said: “The acquisition of ZEMDRI™ deepens our pipeline of specialty products in the U.S. in our identified focus areas of central nervous system, lung delivery of medicines, and institutionally administered products. With a robust front-end commercial infrastructure for U.S. hospital sales in place, we expect to extract strong synergy from our IV Plazomicin and IV Tramadol assets. Cipla has been a leading industry voice in the fight against AMR and our expertise in manufacturing, marketing and conducting educational programs in the antibiotic segment makes us well-placed to take ZEMDRI™ globally to expand our leadership position.” Its Antibiotic Benchmark Report recognised Cipla for its work in educating healthcare practitioners (HCPs), illustrating AMR trends in marketing material, adapting packaging to support rational use, and engaging in AMR surveillance2. In India, Cipla has a long history of antibiotic development from ampicillin in the 1970s to quinolones in the 1990s. More recently, Cipla introduced the extremely effective antibiotic colistin in India.   ]]> <![CDATA[Strides gets EIR from USFDA on continued GMP status]]> https://biospectrumindia.com/news/95/14285/strides-gets-eir-from-usfda-on-continued-gmp-status.html https://biospectrumindia.com/news/95/14285/strides-gets-eir-from-usfda-on-continued-gmp-status.html Thu, 25 Jul 2019 13:10:00 +0530 Strides Pharma Science has announced that its formulations facility located at the KRSG Gardens, in Bengaluru was which was inspected by the US FDA in May 2019, has received the Establishment Inspection Report (EIR). The Bengaluru- based company confirms the successful closure of the inspections by the regulatory authority. Early this week the company communicated that the inspection of the facility was completed successfully with a Voluntary Action Indicated (VAI) classification. This production plant according to Strides is the largest manufacturing facility for it with capabilities to produce finished dosage formulation products across multiple dosage formats including tablet, capsules, ointments, creams and liquids. The products manufactured in India are exported to the key regulated markets of the US, Europe, and Australia. ]]> <![CDATA[Cipla buys prescription drug Zemdri]]> https://biospectrumindia.com/news/95/14284/cipla-buys-prescription-drug-zemdri.html https://biospectrumindia.com/news/95/14284/cipla-buys-prescription-drug-zemdri.html Thu, 25 Jul 2019 12:55:00 +0530 Cipla USA furthers AMR stewardship with acquisition of key anti-infective ZEMDRI™ (IV Plazomicin) Acquisition consistent with Cipla’s legacy of pioneering contribution to global healthcare challenges, industry leadership in anti-microbial resistance (AMR) stewardship practices and expertise in manufacturing, marketing and educational programs in the anti-infective segment Cipla USA Inc. a wholly-owned subsidiary of the leading global pharmaceutical company Cipla Limited has announced the acquisition of the prescription drug ZEMDRI™ (Plazomicin) from Achaogen Inc. (“Achaogen”) in a Chapter 11, U.S. Bankruptcy Code auction of Achaogen’s assets. Cipla USA has acquired worldwide rights of ZEMDRI™ (excluding Greater China) with its allied assets and limited liabilities. ZEMDRI™ is a once-daily novel intravenous (IV) aminoglycoside for the treatment of complicated urinary tract infections (cUTI), including pyelonephritis, in adults who are unresponsive to currently available treatment options. ZEMDRI™ was approved by the United States Food & Drug Administration (USFDA) in June 2018, and was launched in the same year, with patent protection expected to continue until 2031 or 2032. It has been granted a new technology add-on payment (NTAP) by the Centers for Medicare & Medicaid Services (CMS), for its administration in a hospital in-patient setting. The product has also been filed for approval in the European Union (EU). ZEMDRI™ is the latest milestone in Cipla’s history of proactive and humanitarian leadership in enabling access to life-saving drugs. In 2001, at the height of the global HIV movement, Cipla changed the treatment paradigm with its offer of a triple combination anti-retroviral therapy at less than a dollar a day in Africa against the prevailing price of around USD 12,000 a year for one patient. With anti-microbial resistance (AMR) today being an urgent global healthcare challenge, Cipla has been at the forefront of AMR stewardship. Plazomicin is a novel antibiotic effective against some of the cUTI-causing gram-negative bacteria that are resistant to beta-lactam antibiotics including carbapenems. Clinical studies have shown sustained microbiological eradication of the bacteria with Plazomicin. Cipla is a signatory to the Industry Declaration on AMR at the World Economic Forum in Davos in 2016 that laid out a roadmap to combat AMR. More recently, Cipla introduced the extremely effective antibiotic colistin in India. ]]> <![CDATA[Stempeutics partners with Kemwell for stem cell therapeutics]]> https://biospectrumindia.com/news/95/14279/stempeutics-partners-with-kemwell-for-stem-cell-therapeutics.html https://biospectrumindia.com/news/95/14279/stempeutics-partners-with-kemwell-for-stem-cell-therapeutics.html Thu, 25 Jul 2019 11:15:00 +0530 Stempeutics Research, a group company of Manipal Education and Medical Group (MEMG), announced that it has signed a strategic deal with Kemwell Biopharma for global commercialization of its stem cell product Stempeucel®.  Under this agreement, Kemwell will take a minority stake in Stempeutics and invest up to Rs 950 Million based on certain milestones as well as establish a world class cGMP cell therapy manufacturing facility at Kemwell’s facility in Bangalore for contract manufacturing of cell therapy products. Currently Stempeutics is working on three key indications i.e. Critical Limb Ischemia (CLI), Osteoarthritis (OA) and Diabetic Foot Ulcer (DFU).  For marketing the products in India, it has partnered with Cipla for the CLI indication and with Alkem Labs for OA indication. Stempeutics is now exploring registration and commercialization of Stempeucel® in the developed markets i.e. the US, Europe and Japan and has initiated discussions with US FDA, EMA and Japan PMDA. Funds received from Kemwell will be utilized for achieving key regulatory milestones in the US, Europe and Japan. Commenting on the Kemwell collaboration, Dr Ranjan Pai, Chairman, Manipal Education & Medical Group said, “We are progressing well towards our goal of bringing stem cell-based products for unmet medical needs in the Indian market by 2020. Stempeutics has done pioneering work in stem cells R&D and by far, it is the first stem cell company in Asia to demonstrate significant clinical outcomes in CLI. The synergistic combinations of Kemwell & Stempeutics will accelerate the development of novel stem cell-based products for patients and transform India into a global player in stem cell therapeutics”. Mr. Anurag Bagaria, Chairman and CEO, Kemwell added “We believe that Stem Cells will become a major branch of medical treatment and will become a standard of care for challenging diseases. Kemwell is looking forward in building a world-class cGMP facility in Bangalore and make India as an emerging hub for cell therapy manufacturing. We are happy in partnering with Stempeutics because of their strength in developing innovative stem cell products starting from basic research, preclinical studies, large scale manufacturing and conducting multi-centre clinical studies meeting international standards.” Chandru Chawla, Executive Vice President Cipla and Board Member, Stempeutics added “Stempeutics has been at the cutting edge of Stem cell research and remains among the top cell therapy companies in the world bringing therapeutic products for difficult to treat diseases. It has made Invent-in-India a reality”. Mr. BN Manohar, CEO of Stempeutics said, “Our Company’s mission is to “Develop innovative stem cell products addressing major unmet medical needs with an India first, global next approach”. In the past 10 years, we have developed cutting edge technology to bring stem cell products in India to physicians who now have an off-the-shelf stem cell therapy in their hand to fight diseases like Critical Limb Ischemia.  With Kemwell’s investments we plan to register for additional indications for Stempeucel®, expand into the developed markets, and further develop our pipeline.”   ]]> <![CDATA[FDA approves Pfizer’s biosimilar RUXIENCE]]> https://biospectrumindia.com/news/95/14271/fda-approves-pfizers-biosimilar-ruxience.html https://biospectrumindia.com/news/95/14271/fda-approves-pfizers-biosimilar-ruxience.html Wed, 24 Jul 2019 11:50:00 +0530 Pfizer has announced that USFDA has approved RUXIENCE™ (rituximab-pvvr), a biosimilar to Rituxan® (rituximab) for the treatment of adult patients with non-Hodgkin’s lymphoma (NHL), chronic lymphocytic leukemia (CLL), and granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA). Andy Schmeltz, Global President, Pfizer Oncology said, “Biosimilars like RUXIENCE have the potential to deliver real value in healthcare, improving access to and affordability of an important cancer treatment which could help more patients receive optimal care. The FDA approval marks our third oncology biosimilar to be approved in the U.S. this year, reinforcing our commitment to bring these important medicines to patients living with cancer.” The FDA approval was based on the review of a comprehensive data package, which demonstrated biosimilarity of RUXIENCE to the reference product. This includes results from the REFLECTIONS B3281006 clinical comparative study, which evaluated the efficacy, safety and immunogenicity, pharmacokinetics and pharmacodynamics of RUXIENCE and found no clinically meaningful differences in safety or efficacy compared to the reference product in patients with CD20-positive, low tumor burden follicular lymphoma. Dr. Jeff Sharman, medical director, US Oncology Hematology Research said, “Rituximab became one of the first monoclonal antibody (mAb) cancer treatments when it was initially approved by the FDA, representing a significant treatment advance and the only option available to oncologists and their patients for a period of time. With this FDA approval, clinicians have an additional treatment option that will help improve access to care for patients in need of anti-CD20 mAb therapy.” Biosimilars have been a significant catalyst for change for the healthcare industry over the last decade, with the potential to create a more sustainable healthcare system. With more than 10 years of global in-market experience and seven approved biosimilar products in the U.S., Pfizer is proud to be a leader and at the forefront of this vital healthcare segment. RUXIENCE is Pfizer’s third oncology mAb biosimilar to be approved by the FDA this year. RUXIENCE has also been filed for regulatory approval with the European Medicines Agency (EMA) and is under review. RUXIENCE is a mAb biosimilar to Rituxan which works by targeting a protein called CD20, which is present on the surface of B cells. When it attaches to CD20, rituximab helps destroy the B cells.   ]]> <![CDATA[Dr. Reddy's announces launch of Ramelteon Tablets in U.S. Market]]> https://biospectrumindia.com/news/95/14269/dr-reddys-announces-launch-of-ramelteon-tablets-in-u-s-market.html https://biospectrumindia.com/news/95/14269/dr-reddys-announces-launch-of-ramelteon-tablets-in-u-s-market.html Wed, 24 Jul 2019 09:00:00 +0530 Dr. Reddy’s Laboratories Ltd. has announced the launch of Ramelteon Tablets, 8 mg, a therapeutically equivalent generic version of Rozerem® (ramelteon, 8 mg) Tablets, approved by the U.S. Food and Drug Administration (USFDA). The Rozerem® brand had U.S. sales of approximately $91.3 million MAT for the most recent twelve months ending in May 2019 according to IQVIA Health. Dr. Reddy’s Ramelteon Tablets are available as 8 mg tablets in bottle count sizes of 30, 100, and 1000. Rozerem® is a trademark of Takeda Pharmaceutical Company Limited. ]]> <![CDATA[Piramal Pharma Solutions receives recognition from Frost & Sullivan]]> https://biospectrumindia.com/news/95/14265/piramal-pharma-solutions-receives-recognition-from-frost-sullivan.html https://biospectrumindia.com/news/95/14265/piramal-pharma-solutions-receives-recognition-from-frost-sullivan.html Tue, 23 Jul 2019 17:40:00 +0530 Based on its recent analysis of the contract development and manufacturing organization market, Frost & Sullivan recognized Piramal Pharma Solutions ('PPS', 'the business') with the 2019 Global Customer Service Leadership Award. Through its 12 development centers and manufacturing sites across North America, Europe, and Asia, PPS provides end-to-end capabilities to its pharmaceutical customers across the entire drug development life cycle. It combines its global operational capabilities and standardized scheduling to minimize supply chain constraints and shorten delivery timelines for customers. The business also deploys an innovative quality framework across its global manufacturing network. "With unparalleled research and development (R&D) focus, PPS strives to re-engineer its internal capabilities, programs, and new technologies to expedite a drug's time-to-market," said Khushbu Jain, Industry Analyst at Frost & Sullivan. "PPS' offerings include drug discovery, drug development, and drug substance and product commercial manufacturing. By having half of its manufacturing sites in the East and the other half in the West, it ensures flexible scheduling for shorter delivery timelines and significant resource and time savings." PPS' R&D team resolves complex process development and formulation challenges and develops robust processes for customers. The business has proven expertise in injectable capabilities and provides complete contract development and manufacturing capabilities across active pharmaceutical ingredients (API) and formulations, including niche capabilities in handling cytotoxic injectables, hormonal formulations, and high potency APIs (HPAPIs).  ]]> <![CDATA[Laurus Labs launches Pregabalin Capsules in US market]]> https://biospectrumindia.com/news/95/14252/laurus-labs-launches-pregabalin-capsules-in-us-market.html https://biospectrumindia.com/news/95/14252/laurus-labs-launches-pregabalin-capsules-in-us-market.html Tue, 23 Jul 2019 11:05:00 +0530 Laurus Labs Limited, a Hyderabad based research and development driven pharmaceutical company along with its exclusive distribution partner Rising Pharmaceuticals, a Rising Pharma Holdings Inc. company, announce the launch of the generic version of Lyrica®, (pregabalin) Capsules, in all eight commercially available strengths (25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg, & 300 mg) in US market. Rising recently received the final approval from the U.S. Food and Drug Administration (FDA) for the Abbreviated New Drug Application (ANDA). Pregabalin Capsules are indicated for management of neuropathic pain associated with diabetic peripheral neuropathy, for the management of postherpetic neuralgia, for adjunctive therapy for the treatment of partial onset seizures in patients 4 years of age and older, for the management of fibromyalgia, and for the management of neuropathic pain associated with spinal cord injury. The product should be taken only as prescribed. Pregabalin Capsules and had U.S. sales of approximately $5,497 million for the 12 months ending March 2019, according to IMS Health. “Laurus Labs is a fully integrated pharmaceutical company, backed by the state of the art manufacturing facilities in Visakhapatnam, Andhra Pradesh. We are happy to develop and manufacture the Pregabalin capsules for our exclusive distribution partner Rising Pharmaceuticals in US. Currently we have 5 billion units per year capacity which can be expanded to 8 million units per year based on the demand. As we move forward in the FDF segment backed by our strong API manufacturing facilities, with strategic partnerships in place, we will strengthen our portfolio for driving long-term, sustainable growth by leveraging our partnerships and global presence,” said Dr. Satyanarayana Chava, Founder & CEO , Laurus Labs. “The commercialization of Pregabalin Capsules is one of the largest volume launches for the company this year and will provide a cost effective treatment option for people living with debilitating neuropathic pain conditions,” said Vimal Kavuru, Chief Executive Officer for Rising Pharmaceuticals. Rising Pharmaceuticals sells generic prescription products and over-the-counter pharmaceutical products under the Rising label to leading wholesalers, chain drug stores, distributors and mass merchandisers. ]]> <![CDATA[Hamdard launches Wellness Centres in Ghaziabad and Meerut]]> https://biospectrumindia.com/news/95/14245/hamdard-launches-wellness-centres-in-ghaziabad-and-meerut.html https://biospectrumindia.com/news/95/14245/hamdard-launches-wellness-centres-in-ghaziabad-and-meerut.html Tue, 23 Jul 2019 09:00:00 +0530 Hamdard Laboratories, over a 100 year old iconic FMCG company, and India’s leading Health & Wellness business house furthers its expansion into retail with the launch of their next Wellness Centre ‘Hamdard Wellness’ in Ghaziabad recently. The event also marked the launch of the wellness center in Meerut. The Wellness centers in Delhi, Hyderabad, Kanpur, Patna and Bengaluru have been launched, and are hugely successful. Shripad Naik, Minister of State (Independent Charge - AYUSH) & Defence, Govt of India unveiled the Ghaziabad centre. The objective is to spread the natural healing touch of Unani, and reach out to people wanting natural, herbal treatment for lifestyle diseases, and a host of other ailments. The center will offer specialized Unani consultation by experienced doctors and Unani medicines at the fully stocked Unani pharmacy for problems related to Diabetes, Heart, Men Health & Vitality, Women Health & Fertility, Skin & Hair, Digestion & Piles, Bones & Joints, Liver & Gall Bladder, Kidney & Urinary Tract and General Health issues. The center will also offer disease management services by disseminating information on lifestyle related disorders through a series of experiential and awareness focused sessions involving communities. Speaking at the launch, Shripad Naik said, “I appreciate the systematic and dedicated efforts taken by Hamdard to encourage one of the most ancient and effective form of treatment, the Unani system. This is in alignment with the objective of AYUSH ministry to promote and propagate alternative medicine systems and offer quality healthcare services to the society. I am sure that the people of Uttar Pradesh will avail, in large number, this “gateway of health” provided to them by Hamdard.” Commenting on the launch, Hammad Ahmed, Chief Mutawalli, Hamdard Laboratories (India) said, “Uttar Pradesh, and particularly Ghaziabad and Meerut have been key locations in our growth story. We are proud to expand our presence in the city and spread awareness of Unani wellness. It is our mission to strive for the health and well-being of all our customers, and Hamdard Wellness allows us to achieve that mission”. Speaking at the launch event, Mansoor Ali, Chief Marketing & Sales Officer, Hamdard Laboratories (India) said, “There is an increased affinity of consumers towards herbal and natural medicines. People are distancing themselves from synthetic and chemical based products. Evoking huge trust in consumers’ minds, Hamdard sits organically on this positioning. Carrying the distinguished tradition of Unani healing, Hamdard Wellness Centres provide healthcare services to people wanting natural, herbal treatment for lifestyle diseases, and a host of other ailments. Each centre provides specialized Unani consultation by 2-3 doctors, and medicines at the fully stocked pharmacy. Ghaziabad and Meerut are important markets for us and with the launch; we aim to position Hamdard Wellness as the driving force to natural healing. I encourage the consumers of these two cities to experience the healing touch of Unani." Hamdard India is over a 100-year old manufacturer of iconic Unani brands and herbal FMCG products such as RoohAfza, Safi blood purifier, Roghan Badam Shirin, Joshina, Sualin and Cinkara tonic. The flagship centre is located at Asaf Ali Road in New Delhi apart from centres in Lal Kuan, and Jamia Hamdard University (Delhi). There are centres in Hyderabad, Kanpur, Patna, and Bengaluru too.   ]]> <![CDATA[Lupin receives ENR Global Best Project Award for Nagpur facility]]> https://biospectrumindia.com/news/95/14241/lupin-receives-enr-global-best-project-award-for-nagpur-facility.html https://biospectrumindia.com/news/95/14241/lupin-receives-enr-global-best-project-award-for-nagpur-facility.html Mon, 22 Jul 2019 11:45:00 +0530 Pharma major Lupin Limited (Lupin) announced that it has won the Engineering News-Record’s (ENR) Global Best Project Award of Merit in the Manufacturing category. The award was given to Lupin’s Oral Solid Dosage (OSD) and Injectable Pharmaceutical Manufacturing Facility at Nagpur, India. The ENR Global Best Projects Awards are annual awards given by ENR globally as part of an annual competition that identifies and honours the best project teams behind outstanding design and construction efforts. Lupin’s OSD and Injectable facility at Nagpur is Lupin’s latest and most advanced manufacturing unit commissioned in 2018. It is equipped with technologies like an advanced robotic storage and retrieval system and error-free and automated data storage, and the facility is designed to minimise risks associated with cross-contamination using air locks  and multiple process control systems that are automated to keep human intervention to the bare minimum. It is also designed keeping Green building concepts in mind using glass walls for natural light and consideration for LEED® criteria as well as advanced Fire detection and protection systems. Speaking on the win, Mr. Rajendra B Chunodkar, President – Manufacturing Operations, Lupin Limited said, “We are delighted to receive this global award for our Nagpur OSD and Injectable manufacturing facility. Lupin’s Nagpur facility is equipped with the leading manufacturing technologies and automation and robotic systems that enable safe, compliant and error-free production of complex dosage forms. We remain committed to world-class manufacturing and offering superior quality medicines for our customers.” ]]> <![CDATA[Dr Reddy's completes deal with Upsher-Smith Laboratories]]> https://biospectrumindia.com/news/95/14238/dr-reddys-completes-deal-with-upsher-smith-laboratories.html https://biospectrumindia.com/news/95/14238/dr-reddys-completes-deal-with-upsher-smith-laboratories.html Mon, 22 Jul 2019 11:30:00 +0530 Dr. Reddy’s Laboratories Limited announces the closure of the transaction with Upsher-Smith Laboratories, LLC (Upsher-Smith), pursuant to the satisfactory completion of all customary closing conditions including the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (HSR Act), as amended. Under the agreement Dr. Reddy’s sold its US and select territory rights for ZEMBRACE® SYMTOUCH® (sumatriptan injection) 3 mg and TOSYMRATM (sumatriptan nasal spray) 10 mg, which were commercialized through its wholly owned subsidiary, Promius Pharma, LLC. ]]> <![CDATA[Dr Reddy's launches generic version of Allegra-D in the US]]> https://biospectrumindia.com/news/95/14239/dr-reddys-launches-generic-version-of-allegra-d-in-the-us.html https://biospectrumindia.com/news/95/14239/dr-reddys-launches-generic-version-of-allegra-d-in-the-us.html Mon, 22 Jul 2019 11:30:00 +0530 Dr. Reddy’s Laboratories Ltd.has announced the launch of Fexofenadine HCl 60 mg and Pseudoephedrine HCl 120 mg Extended-Release Tablets, USP, an over-thecounter (OTC) store-brand equivalent of Allegra-D® 12 HR Allergy and Congestion Extended-Release Tablets, in the United States market, as approved by the U.S. Food and Drug Administration (USFDA). Dr. Reddy’s OTC Fexofenadine HCl 60 mg and Pseudoephedrine HCl 120 mg Extended-Release Tablets, USP, are used:  For temporary relief of symptoms due to hay fever or other upper respiratory allergies that include runny nose; sneezing; itchy, watery eyes; itching of the nose or throat  For temporary relief of nasal congestion due to the common cold, hay fever or other upper respiratory allergies  To reduce swelling of nasal passages  For temporary relief of sinus congestion and pressure  To temporarily restore freer breathing through the nose "We are pleased to be expanding our pseudoephedrine-based product offering in time for the cough, cold and allergy season,” says Milan Kalawadia, Senior Vice President and Head of US OTC and Specialty Rx Divisions, Dr. Reddy’s Laboratories. “We look forward to collaborating with our customers to provide high-quality, affordable alternatives to consumers.”   ]]> <![CDATA[Cipla gets final approval for generic version of Pfizer’s Lyrica]]> https://biospectrumindia.com/news/95/14235/cipla-gets-final-approval-for-generic-version-of-pfizers-lyrica.html https://biospectrumindia.com/news/95/14235/cipla-gets-final-approval-for-generic-version-of-pfizers-lyrica.html Mon, 22 Jul 2019 11:10:00 +0530 InvaGen Pharmaceuticals, Inc. (“InvaGen”), a wholly-owned subsidiary of the leading global pharmaceutical company Cipla Limited announced the receipt of final approval for its Abbreviated New Drug Application (ANDA) for Pregabalin capsules, 25mg, 50mg, 75mg, 100mg, 150mg, 200mg, 225mg and 300mg from the United States Food and Drug Administration (US FDA).   InvaGen’s Pregabalin Capsules, 25mg, 50mg, 75mg, 100mg, 150mg, 200mg, 225mg and 300mg is AB-rated generic therapeutic equivalent version of Pfizer’s Lyrica®. Pregabalin capsules are indicated for:  Management of neuropathic pain associated with diabetic peripheral neuropathy Management of postherpetic neuralgia Adjunctive therapy for the treatment of partial onset seizures in patients 17 years of age and older Management of fibromyalgia Management of neuropathic pain associated with spinal cord injury  According to IQVIA (IMS Health), Lyrica® had US sales of approximately $5.4Billion for the 12month period ending March 2019. The product is available for shipping immediately. ]]> <![CDATA[Bayer, Bristol-Myers Squibb and Ono Pharma enter into clinical collaboration ]]> https://biospectrumindia.com/news/95/14233/bayer-bristol-myers-squibb-and-ono-pharma-enter-into-clinical-collaboration-.html https://biospectrumindia.com/news/95/14233/bayer-bristol-myers-squibb-and-ono-pharma-enter-into-clinical-collaboration-.html Fri, 19 Jul 2019 14:10:00 +0530 Bayer, Bristol-Myers Squibb Company and Ono Pharmaceutical Co., Ltd. have entered into a clinical collaboration agreement to evaluate the combination of Bayer's kinase inhibitor Stivarga® (regorafenib) and Bristol-Myers Squibb's / Ono's anti-PD-1 immune checkpoint inhibitor, Opdivo® (nivolumab) in patients with micro-satellite stable metastatic colorectal cancer (MSS mCRC), the most common form of mCRC. Regorafenib as monotherapy has demonstrated an overall survival benefit versus placebo in the pivotal Phase III CORRECT study and has shown activity irrespective of micro-satellite status in a retrospective analysis from this study, though with limited responses observed. Despite progress in the treatment of CRC, including the advance of effective immuno-oncology (I-O) treatments for certain subsets of CRC, around 95% of mCRC patients have MSS tumors, for which I-O monotherapy treatment approaches have shown limited activity. Thus, the need for additional treatment options including combination approaches remains high. Encouraging early data have been seen with the combination of regorafenib and nivolumab. In a Phase 1b investigator sponsored trial from Japan called REGONIVO (NCT03406871, EPOC1603), the combination of regorafenib and nivolumab has shown promising preliminary efficacy results. The detailed data of the study were presented at the 2019 American Society of Clinical Oncology (ASCO) Annual Meeting.   Further terms of the clinical collaboration were not disclosed. ]]> <![CDATA[Strides announces final closure of Arrow transaction ]]> https://biospectrumindia.com/news/95/14231/strides-announces-final-closure-of-arrow-transaction-.html https://biospectrumindia.com/news/95/14231/strides-announces-final-closure-of-arrow-transaction-.html Fri, 19 Jul 2019 13:10:00 +0530 Strides Pharma Science has announced the closure of Arrow transaction. Strides Pharma Global Pte Limited, a step-down subsidiary of the Company in Singapore has received AUD 300 Million immediately at closing, while the balance AUD 94 Million will be a deferred consideration backed by a secured interest-bearing instrument. All proceeds net of transaction cost will be used to pare down debt. Strides shall retain global access to IP’s of over 140 products and has concurrently entered into a preferred supply agreement with Arrow and Apotex as the major supplier which will enable Strides to retain profits equivalent to 40%-50% of current Arrow EBITDA. ]]> <![CDATA[Zydus completes enrollment in 3 Phase III trials of NASH drug]]> https://biospectrumindia.com/news/95/14230/zydus-completes-enrollment-in-3-phase-iii-trials-of-nash-drug.html https://biospectrumindia.com/news/95/14230/zydus-completes-enrollment-in-3-phase-iii-trials-of-nash-drug.html Fri, 19 Jul 2019 11:20:00 +0530 Zydus Cadila, an innovation-driven, global pharmaceutical company, announced that it has completed enrollment in EVIDENCES II, EVIDENCES III and EVIDENCES V Phase 3 clinical trials of Saroglitazar Mg for treating Non-Alcoholic SteatoHepatitis (NASH). Patients with NASH have been enrolled in these trials across clinical sites in India and Mexico. Speaking on the development Mr. Pankaj R. Patel, Chairman, Zydus group said, “We are excited about the progress that Saroglitazar Mg has been making in the NASH trials. It is currently being evaluated in over 23 different controlled clinical trials, involving over 3,800 patients. NASH is an area of unmet healthcare need and we are committed to develop this therapy for millions of patients suffering from this deadly disease.” EVIDENCES II is a Phase 3 biopsy-driven trial of Saroglitazar 4 mg versus Placebo in patients with Non-Alcoholic SteatoHepatitis. The primary endpoint will be evaluated by histological improvement of NASH using liver biopsy at the end of 52 weeks. EVIDENCES III is the prospective, multicenter, randomized, double-blind study of Saroglitazar 4 mg versus Placebo in patients with Non-Alcoholic Fatty Liver Disease (NAFLD). This trial will measure the change in liver fat content as measured by non-invasive magnetic resonance imaging (MRI) at week 24. Several other secondary endpoints including Liver stiffness as measured by transient elastography/FibroScan® and Serum alanine aminotransferase (ALT) level will also be evaluated. EVIDENCES V will evaluate the NASH patients over a period of 18 months, measure the change in the liver fat content by magnetic resonance imaging-derived proton density-fat fraction (MRIPDFF) at Week 24 and evaluate the liver biopsy driven endpoints of Saroglitazar 4 mg from baseline to Week 76. Saroglitazar Magnesium was launched in India during September 2013, for the treatment of hypertriglyceridemia and diabetic dyslipidemia in patients with type-2 diabetes not controlled by statins. Saroglitazar Mg has demonstrated beneficial effects in NASH animal models. Saroglitazar Mg favorably affects all components of NASH including steatosis, ballooning, inflammation and fibrosis in NASH models. Saroglitazar Mg has previously demonstrated improvement in both liver enzymes along with favorable effects on lipid and glycemic indices in patients with nonalcoholic fatty liver disease in Phase II clinical trials. NASH is a progressive disease of the liver and a significant unmet medical need. Starting with fat accumulation in liver, this condition can progress to cirrhosis and liver failure. ]]> <![CDATA[Datar Cancer Genetics launches operations in Germany]]> https://biospectrumindia.com/news/95/14214/datar-cancer-genetics-launches-operations-in-germany.html https://biospectrumindia.com/news/95/14214/datar-cancer-genetics-launches-operations-in-germany.html Wed, 17 Jul 2019 12:15:00 +0530 Datar Cancer Genetics (Europe) GmbH has set up its operations in Germany. It will advance access to Datar Cancer Genetics Ltd’s (DCGL) innovative solutions across the European Union and is a key milestone for the organisation. DCGL is one of the leading companies in molecular and genetic analysis and through the GmbH will offer molecular genetic services across the European region. Dr Stefan Schuster, a specialist in oncology diagnostics, will provide strategic leadership to the European operations and expand the outreach of DCGL. “This is a significant step to enhance our international presence in one of the most important markets,” stated Dr Vineet Datta, Executive Director at DCGL. “This reflects our commitment to better serve our customers in Europe, and we will continue to expand our international network“. “The world is facing great challenges today to determine the best strategy for cancer patients, especially those difficult cases with cancer recurrence or lack of treatment response. Our approach in overcoming these challenges comprises of not a single, but an integrative combination of DNA, RNA and cell based analytes to identify the most optimal therapy. We are now very happy to extend this extraordinary service also to Europe” explained Dr Stefan Schuster, MD, Datar Cancer Genetics (Europe) GmbH. Dr Datta added, “Our focus is to change the current oncology paradigm of “one size fits all” model in most of the cancers, to one that is proactive and adapted to the individual patient needs with long-term benefits at all stages. “ ]]> <![CDATA[FDA approves Bayer's Gadavist® injection for use in cardiac MR]]> https://biospectrumindia.com/news/95/14207/fda-approves-bayers-gadavist-injection-for-use-in-cardiac-mr.html https://biospectrumindia.com/news/95/14207/fda-approves-bayers-gadavist-injection-for-use-in-cardiac-mr.html Tue, 16 Jul 2019 15:25:00 +0530 Bayer announced the U.S. Food and Drug Administration (FDA) has approved Gadavist® (gadobutrol) injection for use in cardiac magnetic resonance (MR) imaging to assess myocardial perfusion (stress, rest) and late gadolinium enhancement in adult patients with known or suspected coronary artery disease (CAD). Gadavist is now the first and only contrast agent FDA approved for use in cardiac MR – an important diagnostic tool for patients with CAD. "Gadobutrol-enhanced cardiac MR demonstrated efficacy in a large global multicenter clinical trial," said Daniel S. Berman, MD, FACC, Chief of Cardiac Imaging and Nuclear Cardiology at the Cedars-Sinai Heart Institute and the S. Mark Taper Foundation Imaging Center. "The FDA approval is a landmark for making this validated, non-invasive method available to healthcare professionals to evaluate their patients for the most common form of heart disease in the world." The approval was based on two multinational, non-randomized, blinded-read Phase 3 studies of almost 1,000 adults with suspected or known CAD based on signs and symptoms. Nearly 800 of those patients were evaluated for efficacy. First approved in 2011, cardiac MR is now the fourth FDA approved indication for Gadavist. The Society for Cardiovascular Magnetic Resonance recognizes cardiac MR as a non-invasive tool that provides relevant and actionable information to healthcare professionals. "We now have an approved contrast agent for use in cardiac MR to assess perfusion and late gadolinium enhancement in less than one hour," said Scott Flamm, MD, MBA, Head of Cardiovascular Imaging, Cleveland Clinic. "A Gadavist-enhanced cardiac MR is a key diagnostic tool, providing additional important clinical information, which can help physicians manage their patients with known or suspected CAD." "This latest FDA approval represents another first from Bayer, as Gadavist is the first and only contrast agent approved for cardiac MR," said Dennis Durmis, SVP and Head of Americas Region at Bayer Radiology. "Not only does this approval add to our existing indications for Gadavist, expanding scientific knowledge, but also underscores our dedication to research and provides radiologists and cardiologists with another diagnostic option as they manage their patients with known or suspected CAD." ]]> <![CDATA[Sun Pharma launches Ezallor Sprinkle in the U.S. ]]> https://biospectrumindia.com/news/95/14201/sun-pharma-launches-ezallor-sprinkle-in-the-u-s-.html https://biospectrumindia.com/news/95/14201/sun-pharma-launches-ezallor-sprinkle-in-the-u-s-.html Tue, 16 Jul 2019 12:00:00 +0530 Sun Pharmaceutical Industries Ltd. has announced the U.S. launch of Ezallor Sprinkle (rosuvastatin) capsules for the treatment of three types of elevated lipid disorders in people who have difficulty swallowing, a problem that is estimated to affect approximately 30-35% of long-term care residents. Ezallor Sprinkle is indicated as an adjunct to diet for the treatment of adult patients with hypertriglyceridemia, as an adjunct to diet for the treatment of adult patients with primary dysbetalipoproteinemia (type III hyperlipoproteinemia), and as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) or as monotherapy if such treatments are unavailable, to reduce LDL-C, total cholesterol, and ApoB in adult patients with homozygous familial hypercholesterolemia. Ezallor Sprinkle has not been studied in Fredrickson Type I and V dyslipidemias. “With the introduction of Ezallor Sprinkle, Sun Pharma continues our commitment of providing a portfolio of alternative formulation products to address the needs of people who have difficulty swallowing, which is especially prevalent among residents in long-term care facilities,” said Abhay Gandhi, CEO, North America, Sun Pharma. “These patients often encounter more medication errors and challenges with medication administration as compared to long-term care residents who do not have difficulty swallowing.” “The risk of medication errors increases when people have difficulty swallowing, due to the crushing of medicines that shouldn’t be crushed, or from residual medication leftover in crushing devices,” said Dr. Chris Chappel, certified Medical Director, Chappel Senior Care and Chappel Group Research. “This formulation will help in administering medication for patients with common types of elevated lipid disorders, especially in the geriatric population.” Ezallor Sprinkle is formulated as extended-release-coated pellets that may be sprinkled over soft food such as applesauce, can be swallowed whole, or administered via a nasogastric tube to facilitate long-term, once-daily administration. Ezallor Sprinkle joins Kapspargo Sprinkle (metoprolol succinate) extended-release capsules as the second product in the Sun Pharma portfolio designed for individuals in long-term care. Ezallor Sprinkle is contraindicated in patients with any known hypersensitivity to rosuvastatin, which may include rash, pruritus, urticaria, and angioedema; patients with active liver disease, which may include unexplained persistent elevations of hepatic transaminase levels, and females who are pregnant or breastfeeding. In the controlled clinical trials database, the most common adverse reactions with rosuvastatin were a headache, myalgia, abdominal pain, asthenia, and nausea. ]]> <![CDATA[Jubilant announces price increase of 10% for Vitamin B3 ]]> https://biospectrumindia.com/news/95/14195/jubilant-announces-price-increase-of-10-for-vitamin-b3-.html https://biospectrumindia.com/news/95/14195/jubilant-announces-price-increase-of-10-for-vitamin-b3-.html Tue, 16 Jul 2019 11:20:00 +0530 Jubilant Life Sciences Limited, an integrated global Pharmaceutical and Life Sciences Company, has announced a price increase of 10% for its Vitamin B3 (Niacin & Niacinamide) with immediate effect, for non-contract customers and wherever existing contracts permit. Jubilant is currently the second largest producer of Vitamin B3 globally. The Vitamin B3 business is part of company’s Life Science Ingredients (LSI) segment, which offers a broad portfolio of ingredients that find application in wide range of industries. ]]> <![CDATA[Sun Pharma launches rosuvastatin for lipid disorder treatment]]> https://biospectrumindia.com/news/95/14197/sun-pharma-launches-rosuvastatin-for-lipid-disorder-treatment.html https://biospectrumindia.com/news/95/14197/sun-pharma-launches-rosuvastatin-for-lipid-disorder-treatment.html Tue, 16 Jul 2019 11:20:00 +0530 Sun Pharmaceutical Industries Ltd. has announced the U.S. launch of Ezallor Sprinkle™ (rosuvastatin) capsules for the treatment of three types of elevated lipid disorders in people who have difficulty swallowing, a problem that is estimated to affect approximately 30- 35% of long-term care residents. Ezallor Sprinkle is indicated as an adjunct to diet for the treatment of adult patients with hypertriglyceridemia, as an adjunct to diet for the treatment of adult patients with primary dysbetalipoproteinemia (type III hyperlipoproteinemia), and as an adjunct to other lipid-lowering treatments (e.g., LDL apheresis) or as monotherapy if such treatments are unavailable, to reduce LDL-C, total cholesterol, and ApoB in adult patients with homozygous familial hypercholesterolemia. Ezallor Sprinkle has not been studied in Fredrickson type I and V dyslipidemias. “With the introduction of Ezallor Sprinkle, Sun Pharma continues our commitment of providing a portfolio of alternative formulation products to address the needs of people who have difficulty swallowing, which is especially prevalent among residents in long-term care facilities,” said Abhay Gandhi, CEO, North America, Sun Pharma. “These patients often encounter more medication errors and challenges with medication administration as compared to long-term care residents who do not have difficulty swallowing.” “The risk of medication errors increases when people have difficulty swallowing, due to crushing of medicines that shouldn’t be crushed, or from residual medication left over in crushing devices,” said Dr. Chris Chappel, certified Medical Director, Chappel Senior Care and Chappel Group Research. “This formulation will help in administering medication for patients with common types of elevated lipid disorders, especially in the geriatric population.” Ezallor Sprinkle is formulated as extended-release-coated pellets that may be sprinkled over soft food such as applesauce, can be swallowed whole, or administered via a nasogastric tube to facilitate long-term, once-daily administration. Ezallor Sprinkle joins Kapspargo Sprinkle™ (metoprolol succinate) extended-release capsules as the second product in the Sun Pharma portfolio designed for individuals in long-term care. Ezallor Sprinkle is contraindicated in patients with any known hypersensitivity to rosuvastatin, which may include rash, pruritus, urticaria, and angioedema; patients with active liver disease, which may include unexplained persistent elevations of hepatic transaminase levels, and females who are pregnant or breastfeeding. In the controlled clinical trials database, the most common adverse reactions with rosuvastatin were headache, myalgia, abdominal pain, asthenia, and nausea. ]]> <![CDATA[Cipla EU, Jiangsu Acebright enter into a joint venture]]> https://biospectrumindia.com/news/95/14193/cipla-eu-jiangsu-acebright-enter-into-a-joint-venture.html https://biospectrumindia.com/news/95/14193/cipla-eu-jiangsu-acebright-enter-into-a-joint-venture.html Tue, 16 Jul 2019 11:00:00 +0530 Cipla (EU) Limited, a U.K. based wholly-owned subsidiary of the leading global pharmaceutical company Cipla and Jiangsu Acebright Pharmaceutical Co. Ltd.have announced that they have entered into an agreement to set up a joint venture company in the People’s Republic of China. According to the agreement, upon incorporation, the JV Co will become a subsidiary of Cipla. Cipla EU will hold an 80% stake and Acebright will hold a 20% stake in it for a combined investment of USD 30mn. Upon incorporation, the JV Co will set up a manufacturing facility for local manufacture of respiratory products. Shengping Xu, Chairman of Acebright Group, said, “We have a long-standing partnership of more than 20 years with Cipla which shares our vision and approach towards patients. We are pleased to strengthen our relationship with Cipla through this joint venture and strongly believe the joint venture will bring more products to Chinese patients in the respiratory segment.”  Umang Vohra, MD & Global CEO of Cipla, said, “While our core home markets remain our current growth anchors, we see China as a crucial part of our future roadmap. In May, we inaugurated our office in Shanghai. We have a long-standing relationship with Acebright, and this partnership to build a manufacturing facility in China is a significant step for us. We are keen to take our well-established expertise in the respiratory segment to patients in China. Simultaneously, we will explore various routes to build a portfolio of products in other therapeutic segments such as oncology. For over eight decades, Cipla has stood for Caring for Life in India and around the world, and we will continue to work towards meeting unmet patient needs through this venture.”   ]]> <![CDATA[Takeda expands India portfolio of rare disease therapies ]]> https://biospectrumindia.com/news/95/14186/takeda-expands-india-portfolio-of-rare-disease-therapies-.html https://biospectrumindia.com/news/95/14186/takeda-expands-india-portfolio-of-rare-disease-therapies-.html Tue, 16 Jul 2019 09:00:00 +0530 Takeda has announced the launch of its Enzyme Replacement Therapy portfolio for Lysosomal Storage Disorders (LSD) in India in line with its commitment to address the unmet needs of patients living with rare diseases in India. Under Lysosomal Storage Disorders – India has been recording the prevalence of Hunter Syndrome, Gaucher Disease and Fabry Disease. To address these, Takeda brings to the market Idursulfase for Hunter Syndrome, Velaglucerase Alpha for Gaucher Disease and Agalsidase Alfa for Fabry Disease. These launches build on the company’s heritage and commitment to India and its strong legacy of making live a better health and brighter future to patients with rare diseases. According to Vineet Singhal, Country Head, Takeda India, “At Takeda, we are committed to patient care by developing innovative new medicines and making existing medicines more readily available. Takeda is working towards shortening the time to diagnosis for rare diseases, with the aim to help healthcare practitioners support patients along the entire journey to enable them to better manage their care. Takeda in India has also been the pioneer in the management of Haemophilia which has transformed the lives of thousands of patients.” Fabry disease interferes with the body's ability to break down a specific fatty substance (globotriaosylceramide or Gb3). Nearly 8,000 to 10,000 people worldwide, including both males and females has been affected by Fabry. Hunter Syndrome is a serious genetic disorder that interferes with the body's ability to break down specific mucopolysaccharides, also known as glycosaminoglycans or GAGs. It primarily affects males. Gaucher is a rare inherited metabolic condition which affects approximately 1 in 100,000 people in the general population. Patients with type 1 Gaucher disease may experience varying symptoms and degrees of disease severity, making it difficult to diagnose. In 2006, the U.S. Food and Drug Administration granted Takeda (erstwhile Shire Pharmaceuticals) approval to market Idursulfase. Since then, more than 95% of Hunter patients have benefited from this drug globally. The use of Idursulfase has shown an increased life expectancy of 11.8 years with 54% reduction in mortality for patients. Velaglucerase Alpha was approved by the U.S. FDA in 2010, showcasing Gaucher patients reach normalization across various clinical parameters like, Liver volume, Spleen volume, Lumbar Spine BMD Z score, Blood Platelet count and Hb count with a marked reduction in Lyso-Gb1 level. 3.  The European Medicines Agency has also granted the use of Velaglucerase Alpha in the European Union. Agalsidase Alfa brings almost 2 decades of global clinical experience with majority of patients using it. Data shows Agalsidase Alfa demonstrated 10-year benefit across cardiac function, structure and symptoms. It is in use in many countries, including Canada, Russia, the United Kingdom, Mexico, Israel, and many members of the European Union.     ]]> <![CDATA[Experts focus on critical management of pharma supply chain]]> https://biospectrumindia.com/news/95/14177/experts-focus-on-critical-management-of-pharma-supply-chain.html https://biospectrumindia.com/news/95/14177/experts-focus-on-critical-management-of-pharma-supply-chain.html Fri, 12 Jul 2019 21:00:00 +0530 In the emerging age of biologics, gene therapies and personalised medicine, pharmaceutical products – drugs and medicines – will have short lifespans, must be shipped in tightly managed, cryogenic conditions and in just-in-time timelines. And here is where supply chain management becomes critical. During a day-long series of panel discussions in Mumbai on ‘The Future of Supply Chain Management’, participants and discussants underscored the importance of putting the patient at the centre of healthcare delivery and medicine. In other words, meeting global standards in supply chain management are essential for ensuring safe, efficacious and quality medicines to people who need them, when they need them. This process begins with the sourcing of the active pharmaceutical ingredient (API) and goes through the manufacture, packaging, distribution and storage of medicines before it reaches the patient at the other end. The integrity of the supply chain is what makes the outcomes patient-centric. Yet, many of us are familiar with media reports of frequent instances wherein counterfeit and poor quality medicines have caused unnecessary loss of people’s lives. Participants and experts on the panels shared learnings and cited lessons from other industries like fast moving consumer goods (FMCG), an industry which also deals extensively in perishables. Others talked about what it took to build a really good supply chain, the roles that logistics and warehousing played in making sure that medicines do not lose their efficacy (or curative power) during transportation and storage. A key panel explained how artificial intelligence and blockchain technology ensures that supply chains operate with 100 per cent precision. Case studies and examples of what other countries are doing that we can learn from were also shared. Ensuring quality of medicine is a responsibility of the pharmaceutical industry, said A Vaidheesh, President Organisation of Pharmaceutical Producers of India (OPPI). “Global best- practices ensure that the quality of medicine is not compromised for the Indian patient.” Kanchana TK, Director General, OPPI added, “Making medicines is a series of complex processes involving manufacturing, supply chain, intermediaries and markets. Ensuring the integrity of the supply chain till it reaches the patient is critical. The future of the pharma supply chain will only get more advanced with the advent of technology and its interface.” “The future of pharma supply chain will need to ensure that medicines delivered to patient retain effectiveness. Tech-enabled supply chain will not only increase efficiency and quality of medicines dispensed but will also encourage patient-centred care.” said Sudarshan Jain, Director General, Indian Pharmaceutical Alliance (IPA). Daara Patel, Secretary General, Indian Drug Manufacturers Association (IDMA) was just as emphatic on the importance of supply chain integrity. “We have several thousand manufacturers involved in making medicines,” he said. “Making sure that they all adhere to the global manufacturing practices is important to patient safety.”   ]]> <![CDATA[Natco files ANDA for Bosentan 32mg Tablets ]]> https://biospectrumindia.com/news/95/14175/natco-files-anda-for-bosentan-32mg-tablets-.html https://biospectrumindia.com/news/95/14175/natco-files-anda-for-bosentan-32mg-tablets-.html Fri, 12 Jul 2019 13:25:00 +0530 Natco Pharma Limited is pleased to announce its submission of an Abbreviated New Drug Application (ANDA) with Para IV certification with U.S. Food and Drug Administration (FDA) for the generic version of Bosentan 32mg tablets for oral suspension. Bosentan 32mg tablets are sold by Actelion Pharmaceuticals US, Inc. (acquired by Johnson & Johnson), under the brand Tracleer®. NATCO believes that its ANDA is possibly the sole first-to-file based on the filing date. We further believe that our ANDA may be eligible for 180 days of marketing exclusivity at the time of potential launch of the product. Tracleer® is indicated for the treatment of pulmonary arterial hypertension. As per Johnson & Johnson’s annual report, for the year ending 2018, Tracleer® had registered sales of approx. $268million in the US market, and the 32 mg is one strength that is indicated for pediatric patients. ]]> <![CDATA[Glenmark & Torrent to co-market diabetic drug in India]]> https://biospectrumindia.com/news/95/14174/glenmark-torrent-to-co-market-diabetic-drug-in-india.html https://biospectrumindia.com/news/95/14174/glenmark-torrent-to-co-market-diabetic-drug-in-india.html Fri, 12 Jul 2019 13:00:00 +0530 Glenmark Pharmaceuticals Ltd. (Glenmark), and Torrent Pharmaceuticals Limited (Torrent) have announced that they have entered into a non-exclusive sub-licensing agreement to co-market sodium glucose co-transporter-2 (SGLT2) inhibitor, Remogliflozin Etabonate (Remogliflozin) in India. Under the terms of the agreement, Glenmark will receive an upfront payment, license fees and royalties for the non-exclusive sub-license rights from Torrent. Glenmark will manufacture and supply Remogliflozin while Torrent will market the drug under its own trademark ‘Zucator’ in India. In April 2019, Glenmark received approval from the Drugs Controller General of India (DCGI) for Remogliflozin Etabonate after successfully completing Phase-3 clinical trials in which Remogliflozin demonstrated good efficacy and safety profile in a head-to-head comparison against Dapagliflozin. Subsequently, Glenmark launched Remogliflozin indicated in the treatment of Type 2 Diabetes Mellitus in adults under the brand names ‘Remo’ and ‘Remozen’ while Torrent will commercialize Remogliflozin under the brand name ‘Zucator’. Moreover, Remogliflozin is available at a breakthrough price that is significantly lower and cost effective over other SGLT-2 inhibitors available in the country. Infact, Remogliflozin is the only SGLT2 inhibitor to be manufactured in India from active pharmaceutical ingredient (API) to formulation. “We are pleased to partner and work closely with Torrent to provide access to innovative solutions for efficient diabetes management in India. The burden of diabetes in India is growing at an alarming rate and through this collaboration, we aim to improve access to the latest, novel and globally researched SGLT2 inhibitor by providing an effective, high quality and world-class treatment option to patients in India. This partnership will also lay the foundation for a long term collaboration with Torrent for Remogliflozin in terms of its additional line extensions and further clinical development,” said Sujesh Vasudevan, President, India Formulations, Middle East and Africa at Glenmark Pharmaceuticals. Dhruv Gulati, Executive Director (India & ROW), Torrent Pharma, said “We are pleased to collaborate with Glenmark for the novel anti-diabetic drug Remogliflozin. The drug will augment the Type 2 Diabetes Mellitus treatment armamentarium in the country and this partnership will be an important step towards enhancing access to the growing needs of diabetic patients.” ]]> <![CDATA[Abbott's FreeStyle Libre System reduces HbA1c levels in people with Type 2 diabetes ]]> https://biospectrumindia.com/news/95/14169/abbotts-freestyle-libre-system-reduces-hba1c-levels-in-people-with-type-2-diabetes-.html https://biospectrumindia.com/news/95/14169/abbotts-freestyle-libre-system-reduces-hba1c-levels-in-people-with-type-2-diabetes-.html Thu, 11 Jul 2019 12:10:00 +0530 Abbott has announced new data showing use of its FreeStyle Libre system, the company's revolutionary continuous glucose monitoring (CGM) technology, significantly reduced hemoglobin A1c (HbA1c) levels for people living with Type 2 diabetes on intensive insulin therapy.2 The results were analyzed from retrospective, real-world data in three countries across Europe and presented as a late-breaker (Abstract 99-LB) at the American Diabetes Association (ADA) 79th Scientific Sessions in San Francisco. The goal of the combined analysis of three individual studies was to determine the impact of using the FreeStyle Libre system on glycemic control in people on intensive insulin therapy living with Type 2 diabetes, the most common form of diabetes where the body is unable to make enough insulin to keep blood glucose levels normal. Researchers evaluated de-identified records of 363 individuals across France, Germany and Austria, assessing their HbA1c levels over three to six months in people averaging about 63 years in age who use insulin multiple times a day for an average of more than eight years. The results – which represent the first time researchers evaluated real-world data specifically from people with Type 2 diabetes who use the FreeStyle Libre system3 – showed lower HbA1c levels with the use of Abbott's technology after at least three months of use. The nearly 1% drop (-0.9% or -9.7 mmol/mol) in HbA1c represents a significant reduction of glucose levels toward the ADA's recommended A1c goal of 7% for adults with diabetes (not including women who are pregnant).4 Other notable findings showed: Average HbA1c was 8.9% (73.3 mmol/mol) prior to FreeStyle Libre system use and 8.0% (63.6 mmol/mol) following use of the technology.There were no differences detected based on age group, gender, body mass index or duration of insulin use, indicating the findings apply to the broad population of people with Type 2 diabetes and not just a particular subset."These real-world findings highlight how Abbott's FreeStyle Libre system can fundamentally change how people manage their diabetes, especially for people living with Type 2 diabetes," said Helene Hanaire, M.D., University Hospital Center of Toulouse in Toulouse, France, and one of the lead authors of the study. "By using the real-time results, trends and patterns from the technology right at their fingertips, people with diabetes are becoming more actively engaged in making better decisions to control their glucose levels and improve their own health." Real-World Data and Clinical Research Emphasize the Role of the FreeStyle Libre System in Potentially Changing the Standard of Care Hemoglobin A1c levels, which reflect a person's average blood sugar over a period of three months, serve as the gold standard to indicate a person's risk for developing long-term complications from diabetes. For people managing diabetes, the goal of reaching normal A1c levels is one of the critical success measurements because it is correlated with long-term health outcomes. This real-world data, coupled with a recently published independent randomized controlled trial study in Diabetes Care, further confirms that the use of FreeStyle Libre system significantly reduces HbA1c levels and improves glucose control in people with Type 2 diabetes.5 Additionally, growing evidence shows access to time in range (TIR) and reports like the Ambulatory Glucose Profile (AGP), which gives a more simplified and clear overview of glucose levels and patterns over time, can be valuable tools to improve glycemic control and enhance the standard of care in addition to HbA1c to better manage diabetes. "Doctors tell us that FreeStyle Libre is changing the course of care for people with diabetes, and the combination of these real-world data and clinical research is further proof that our technology delivers significant reductions in HbA1c in people with Type 2 diabetes," said Mahmood Kazemi, M.D., divisional vice president, global medical and scientific affairs, Diabetes Care, Abbott. "This adds to growing evidence from more than half a million users in real-world settings showing time after time, use of FreeStyle Libre is associated with improved glucose control and better health outcomes. With more than 425 million people living with diabetes around the world, there's an immense opportunity for Abbott's technology to change more lives and the future of those with diabetes." Abbott′s FreeStyle Libre system is now being used by more than 1.5 million people living with diabetes across 46 countries.6 Abbott has secured partial or full reimbursement for the FreeStyle Libre system in 33 countries, including France, Ireland, Japan, the United Kingdom, and the U.S. FreeStyle Libre 14 day system is also offered for Medicare patients in the U.S. based on eligibility.7 1 International Diabetes Federation. About Diabetes. https://www.idf.org/aboutdiabetes/what-is-diabetes/facts-figures.html. Accessed May 2019. 2 Kröger, J., Fasching, P, Hanaire, H, Meta-Analysis of Three, Real-World, Chart Review Studies to Determine the Effectiveness of FreeStyle Libre Flash Glucose Monitoring System on HbA1c in Adults with Type 2 Diabetes. Presented at the American Diabetes Association (ADA) 79th Scientific Sessions in San Francisco, California, USA. 3 Compared to anonymized data evaluating records from both Type 1 and Type 2 patients. 4 American Diabetes Association. A1C and eAG. http://www.diabetes.org/living-with-diabetes/treatment-and-care/blood-glucose-control/a1c/. Last accessed May 2019. 5 Yaron, M. et al. Effect of Flash Glucose Monitoring Technology on Glycemic Control and Treatment Satisfaction in Patients with Type 2 Diabetes. Diabetes Care. Published online April 29, 2019. 6 Data on file. Abbott Diabetes Care. 7 For Medicare patients, please visit the Medicare Guide for more information. Patients must meet Medicare eligibility coverage criteria. ]]> <![CDATA[Lupin launches Imatinib Mesylate tablets]]> https://biospectrumindia.com/news/95/14150/lupin-launches-imatinib-mesylate-tablets.html https://biospectrumindia.com/news/95/14150/lupin-launches-imatinib-mesylate-tablets.html Wed, 10 Jul 2019 09:00:00 +0530 Pharma major Lupin Limited (Lupin) announced the launch of Imatinib Mesylate Tablets, 100 mg (base) and 400 mg (base). Lupin’s alliance partner Natco had received an approval from the United States Food and Drug Administration (U.S. FDA) earlier. Lupin’s Imatinib Mesylate Tablets, 100 mg (base) and 400 mg (base), is the generic version of Novartis Pharmaceuticals Corporation’s (Novartis) Gleevec® Tablets, 100 mg and 400 mg. It is indicated for the treatment of: Newly diagnosed adult and pediatric patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase. Patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in blast crisis (BC), accelerated phase (AP), or in chronic phase (CP) after failure of interferon-alpha therapy Adult patients with relapsed or refractory Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL) Adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with PDGFR (platelet- derived growth factor receptor) gene re-arrangements as determined with an FDA-approved test Adult patients with aggressive systemic mastocytosis (ASM) without the D816V c-Kit mutation as determined with an FDA-approved test or with c-Kit mutational status unknown Adult patients with hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukemia (CEL) who have the FIP1L1-PDGFRα fusion kinase (mutational analysis or FISH demonstration of CHIC2 allele deletion) and for patients with HES and/or CEL who are FIP1L1-PDGFRα fusion kinase negative or unknown Adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (DFSP)  Imatinib Mesylate Tablets, 100 mg (base) and 400 mg (base), had annual sales of approximately USD 548 million in the US (IQVIA MAT May 2019). ]]> <![CDATA[Intas becomes first to launch Romiplostim in India]]> https://biospectrumindia.com/news/95/14151/intas-becomes-first-to-launch-romiplostim-in-india.html https://biospectrumindia.com/news/95/14151/intas-becomes-first-to-launch-romiplostim-in-india.html Wed, 10 Jul 2019 09:00:00 +0530 One of India's leading pharmaceutical companies, Intas Pharmaceuticals, takes a revolutionary step towards making therapy for chronic immune thrombocytopenia (ITP) more accessible to patients by being the first to launch Romiplostim in India under the name Romy. Romiplostim is one of the most efficacious agents with proven long-term benefits in chronic ITP. It represents the standard of care but has been available only internationally since 2008. It is estimated that around 42,000 patients are diagnosed with ITP in India every year. Less than 10% of patients which include adults, as well as children, have access to the treatment which is required to maintain adequate platelet counts for a longer duration. In ITP, long term use of drugs is required to maintain adequate platelet count.    The currently available standard of care therapy for chronic ITP costs approximately ~Rs.60,000 per month, which can financially drain most patients. Hence, there was an unmet need for a drug like Romiplostim, which is accessible to the majority of patients and gives one of the best responses amongst the available treatment options. To fulfil this unmet need, Intas Pharmaceuticals Ltd. introduces Romiplostim for the first time in India, with the brand name Romy®. With the launch of Romy®, which is priced at Rs. 2,995 for a dose of 250 mcg, the monthly cost of treatment for most patients will be less than Rs.12,000, a huge relief to the chronic ITP patients across the country. Dr. Mammen Chandy, Director of Tata Medical Center, Kolkata and Padma Shri award winner, shared his views on this landmark launch, saying, "Romiplostim's introduction in India will help clinicians immensely as it will add to their therapeutic armamentarium in managing thrombocytopenia due to Chronic ITP and Bone Marrow Failure. Even in patients developing hepatotoxicity due to Eltrombopag, Romiplostim will be considered as a choice of treatment."  Talking more about the launch, Dr. MB Agarwal, one of the leading haematologists in the country, said, "Romiplostim is an injection given below the skin (like insulin) once a week which was available in U.S., Europe and Australia for almost a decade but was never marketed in India. Patients were using an oral pill - Eltrombopag on a daily basis at the cost of almost 2,750 per day. With Intas, Romiplostim's cost for treating chronic ITP will come down by almost six times. Approved for ITP, this drug may be used by clinicians as per their discretion for managing low platelet counts due to other reasons as well." ITP is an autoimmune blood disorder which leads to low platelet counts. Platelets are responsible for the clotting of blood, and a reduced platelet count can lead to life-threatening bleeding complications, including bleeding in the brain.   ]]> <![CDATA[Dr. Reddy’s launches OTC store brand equivalent of Mucinex® D tablets]]> https://biospectrumindia.com/news/95/14148/dr-reddys-launches-otc-store-brand-equivalent-of-mucinex-d-tablets.html https://biospectrumindia.com/news/95/14148/dr-reddys-launches-otc-store-brand-equivalent-of-mucinex-d-tablets.html Tue, 09 Jul 2019 14:15:00 +0530 Dr. Reddy’s Laboratories Ltd. has announced the launch of an over-the-counter (OTC) store-brand equivalent of Mucinex® D Extended Release Tablets in two strengths—Guaifenesin 600 mg and Pseudoephedrine HCl 60 mg, and Guaifenesin 1200 mg and Pseudoephedrine HCl 120 mg—in the United States market, as approved by the U.S. Food and Drug Administration (USFDA).  Dr. Reddy’s OTC Guaifenesin and Pseudoephedrine HCl is used to help loosen phlegm (mucus) and thin bronchial secretions to rid the bronchial passageways of bothersome mucus and make coughs more productive; temporarily relieve nasal congestion due to common cold, hay fever, and upper respiratory allergies; temporarily restore freer breathing through the nose; promote nasal and/or sinus drainage; and temporarily relieve sinus congestion and pressure.  "We are excited to bring first to market the store-brand equivalent of Mucinex® D Maximum Strength Extended Release Tablets. These launches illustrate our continued commitment to the OTC business and our growing portfolio in the cough, cold and allergy category,” says Milan Kalawadia, Senior Vice President and Head of US OTC and Specialty Rx Divisions, Dr. Reddy’s Laboratories.  The Mucinex® D brand and store brands had combined U.S. sales of approximately $71 million MAT for the most recent twelve months ending in May 2019 according to IRI.  Dr. Reddy’s OTC Guaifenesin 1200 mg and Pseudoephedrine HCl 120 mg is available in 24-count packages.  Dr. Reddy’s OTC Guaifenesin 600 mg and Pseudoephedrine HCl 60 mg is available in 18- and 36-count packages.  Mucinex is a trademark of RB HEALTH (US) LLC. ]]> <![CDATA[Glenmark receives ANDA approval for Ranolazine Extended-Release Tablets]]> https://biospectrumindia.com/news/95/14142/glenmark-receives-anda-approval-for-ranolazine-extended-release-tablets.html https://biospectrumindia.com/news/95/14142/glenmark-receives-anda-approval-for-ranolazine-extended-release-tablets.html Tue, 09 Jul 2019 11:20:00 +0530 Glenmark Pharmaceuticals Inc. has been granted final approval by the United States Food & Drug Administration for Ranolazine Extended-Release Tablets, 500 mg and 1,000 mg, a generic version of Ranexa® Extended-Release Tablets, 500 mg and 1,000 mg, of Gilead Sciences, Inc. According to IQVIATM sales data for the 12 month period ending May 2019, the Ranexa® Extended-Release Tablets, 500 mg and 1,000 mg market2 achieved annual sales of approximately $929.0 million. Glenmark’s current portfolio consists of 158 products authorized for distribution in the U.S. marketplace and 57 ANDA’s pending approval with the USFDA. ]]> <![CDATA[IIL organises animal vaccination camps]]> https://biospectrumindia.com/news/95/14141/iil-organises-animal-vaccination-camps.html https://biospectrumindia.com/news/95/14141/iil-organises-animal-vaccination-camps.html Tue, 09 Jul 2019 11:15:00 +0530 Indian Immunologicals Limited (IIL), a leading biologicals company, recently organized free Vaccination Camps in over 170 centres across the country. The market leader in veterinary biologicals and one of the largest animals & human health players in India, IIL has been organizing these Vaccination and Rabies awareness camps at Veterinary dispensaries, NGOs and Veterinarians across the country every year on “World Zoonosis Day” which is observed every year on the 6th of July. Around 50,000 doses of RAKSHARAB (anti-rabies vaccine) produced by IIL was administered free of cost in as many as 20 states and Union Territories through veterinary dispensaries, NGOs etc.   Diseases that transmit from animals to human beings are called Zoonotic diseases and 70% of all emerging diseases that affect humans are zoonotic in nature. In India, occurrence of Rabies is prevalent and accounts for more than 90% of all zoonotic cases reported in the country. The World Health Organisation (WHO) estimates around 1.75 million dog bite cases every year causing around 59,000 deaths worldwide each year with majority of cases (95%) taking place in Africa and Asia. A 2015 study, published in peer-reviewed PLOS Neglected Tropical Diseases estimates about 20,800 rabies deaths every year in India - the highest in the world at 36% of total deaths due to rabies.   The economic cost of dog mediated rabies has been estimated to be $ 8.6 billion. The high incidence of rabies in India is due to large uncontrolled stray dog population in India. Stray dogs account for nearly 80% of the canine population in India. There are several reasons for the high incidence including poor vaccination. Prophylaxis through vaccination is the most cost-effective intervention to reduce incidence of disease. Several countries have been able to reduce the number of rabies related human deaths through vaccination of dogs.   On the occasion of World Zoonosis Day, Dr.K. Anand Kumar, Managing Director, Indian Immunologicals Limited said, “IIL is truly a One Health company, playing a significant role in providing cost effective tools for the control of various zoonotic diseases in the country including the dreaded Rabies. Working with various other stake holders including the common public, IIL is determined to eradicate disease.”   “IIL wishes to spread the message that preventive vaccination is a proven and cost-effective means to minimize incidence of zoonotic diseases. Effective implementation of Swachh Bharat programme and preventive vaccination would vastly improve the health status of the country,” added Dr. Prasanna Deshpande, Deputy Managing Director, Indian Immunologicals Limited.   In addition to Rabies, other Zoonotic diseases such as Brucellosis, Leptospirosis, Swine Flu, Porcine Cysticercosis, Nipah, Zika etc. also affect human beings. Awareness, accurate diagnosis, improvement in sanitary conditions, prophylactic vaccination are all measures that need to be taken to restrain/eradicate spread.   Indian Immunologicals Limited (a subsidiary company of National Dairy Development Board) is leading biologicals manufacturer. Through extensive research, the company has delivered affordable vaccines for the consumers in India. IIL continues to be a leading manufacturer of animal rabies vaccine (Raksharab) and human rabies vaccine (Abhayrab) in the country. IIL’s CYSVAX is the world’s first vaccine for Porcine Cysticercosis in Pigs. Cysticercosis is a very important zoonotic disease and it is understood that it is a prime cause of epilepsy in humans. Vaccinating Pigs against Porcine Cysticercosis can help significantly reduce the incidence of epilepsy in humans. ]]> <![CDATA[Lupin receives USFDA approval for Cinacalcet Tablets]]> https://biospectrumindia.com/news/95/14119/lupin-receives-usfda-approval-for-cinacalcet-tablets.html https://biospectrumindia.com/news/95/14119/lupin-receives-usfda-approval-for-cinacalcet-tablets.html Fri, 05 Jul 2019 15:20:00 +0530 Lupin has announced that it has received approval for its Cinacalcet Tablets, 30 mg, 60 mg, and 90 mg from the United States Food and Drug Administration. Lupin’s Cinacalcet Tablets, 30 mg, 60 mg, and 90 mg, is the generic version of Sensipar Tablets, 30 mg, 60 mg, and 90 mg, of Amgen Inc. It is indicated in the treatment of: secondary hyperparathyroidism (HPT) in adult patients with chronic kidney disease on dialysis hypercalcemia in adult patients with Parathyroid Carcinoma severe hypercalcemia in adult patients with primary HPT who are unable to undergo parathyroidectomy Cinacalcet Tablets, 30 mg, 60 mg, and 90 mg, had annual sales of approximately USD 1527 million in the US. ]]> <![CDATA[GSK gets EU marketing nod for its HIV drug]]> https://biospectrumindia.com/news/95/14114/gsk-gets-eu-marketing-nod-for-its-hiv-drug.html https://biospectrumindia.com/news/95/14114/gsk-gets-eu-marketing-nod-for-its-hiv-drug.html Thu, 04 Jul 2019 15:55:00 +0530 ViiV Healthcare, the global specialist HIV company, majority owned by GlaxoSmithKline, with Pfizer Inc. and Shionogi Limited as shareholders, have announced that the European Commission has granted Marketing Authorisation for Dovato (dolutegravir/lamivudine) for the treatment of HIV-1 infection in adults and adolescents above 12 years of age weighing at least 40 kg, with no known or suspected resistance to the integrase inhibitor class, or lamivudine.   Deborah Waterhouse, CEO, ViiV Healthcare, said: “For many years, the standard of care for treatment-naïve people living with HIV in Europe has been a three-drug regimen. The data from our dolutegravir-based two-drug regimen development programme challenges this, and with the authorisation of Dovato, people living with HIV can for the first time start treatment on a once-daily, single-pill, two-drug regimen with the knowledge that efficacy is non-inferior to a three-drug regimen whilst containing fewer antiretrovirals. Dovato strengthens ViiV Healthcare’s industry-leading portfolio of innovative treatment approaches for people living with HIV.” With around 25,000 new HIV diagnoses in Europe every year, and the fact that today HIV is considered a chronic condition which requires people living with HIV (PLHIV) to remain on antiretroviral (ARV) treatment for life, it is ever more important to provide innovative treatment options. Marketing Authorisation for Dovato is supported by data from the landmark global GEMINI 1 and 2 studies that included more than 1,400 HIV-1 infected adults. In these studies, dolutegravir  and lamivudine demonstrated non-inferior efficacy based on plasma HIV-1 RNA <50 copies per millilitre (c/mL), a standard measure of HIV control, at week 48 when compared to a three-drug regimen of dolutegravir and two nucleoside reverse transcriptase inhibitors (NRTIs), tenofovir disoproxil fumarate/emtricitabine (TDF/FTC), in treatment-naïve, HIV-1 infected adults. The safety results for dolutegravir and lamivudine seen in GEMINI 1 and 2 were consistent with the product labelling for dolutegravir and lamivudine. Four patients (1%) in both the dolutegravir and lamivudine, and the dolutegravir and TDF/FTC, study arms experienced drug-related serious adverse events, and 15 patients (2%) in the dolutegravir and lamivudine arm and 16 patients (2%) in the dolutegravir and TDF/FTC arm had adverse events that led to discontinuation. The most common adverse reactions included headache, diarrhoea, nausea, insomnia, and fatigue. No patient who experienced virologic failure in either treatment arm developed treatment-emergent resistance also up to week 48. ]]> <![CDATA[Dr. Reddy's announces first-to-market launch of Carboprost Tromethamine Injection USP]]> https://biospectrumindia.com/news/95/14097/dr-reddys-announces-first-to-market-launch-of-carboprost-tromethamine-injection-usp.html https://biospectrumindia.com/news/95/14097/dr-reddys-announces-first-to-market-launch-of-carboprost-tromethamine-injection-usp.html Wed, 03 Jul 2019 13:30:00 +0530 Dr. Reddy’s Laboratories Ltd., along with its subsidiaries together referred to as “Dr. Reddy’s”) today announced the launch of Carboprost Tromethamine Injection USP, 250 mcg/mL (1mL) Single-dose Vial, a therapeutic equivalent generic version of Hemabate® injection,  250 mcg/mL, approved by the U.S. Food and Drug Administration (USFDA).   “We are pleased to be first-to-market with this product that has been designated as a Competitive Generic Therapy (CGT) by the FDA,” says Marc Kikuchi, Chief Executive Officer, North America Generics, Dr. Reddy’s Laboratories. “With a CGT designation, we have 180-day CGT exclusivity to market this product.”  The Hemabate® injection, 250 mcg/mL brand had U.S. sales of approximately $55 million MAT for the most recent twelve months ending in April 2019 according to IQVIA Health.  ]]> <![CDATA[Gilead Sciences announces launch of APAC Rainbow Grants Program in India]]> https://biospectrumindia.com/news/95/14094/gilead-sciences-announces-launch-of-apac-rainbow-grants-program-in-india.html https://biospectrumindia.com/news/95/14094/gilead-sciences-announces-launch-of-apac-rainbow-grants-program-in-india.html Wed, 03 Jul 2019 12:00:00 +0530 Gilead Sciences has announced the launch of the 2019 Gilead Asia Pacific Rainbow Grants program, an initiative that supports community-led programs for people living with HIV in the Asia Pacific region. For the first time, non-governmental or advocacy organizations in India are invited to submit their applications for funding online at the Gilead Grant Portal starting today. The submission deadline ends on 30 September 2019. This year’s grants program seeks to improve the quality of life of people living with HIV by focusing on three priority areas: 1) access and quality of life; 2) multidisciplinary care; and 3) diversity andinclusion. In 2016, UNAIDS established the 90-90-90 targets, which aim to diagnose 90 percent of all HIV-positive persons, provide treatment to 90 percent of those diagnosed and achieve viral suppression for 90 percent of those treated. However, as HIV care evolves, there is an increasing need to look at HIV outcomes beyond viral suppression. The “Fourth 90,” an additional target to the UNAIDS 90-90-90 goals, adds a focus on the experience of people living with the disease, setting a target to ensure their care extends beyond viral suppression to health-related quality of life.  “We are pleased to bring the Rainbow Grants program to India this year. Gilead has been championing the cause of access to care in India and we believe in the power of partnerships to bring about solutions that can make a difference,” said Rahul Bargaje, MD, Public Health and Medical Affairs Director at Gilead Sciences India. “We hope this grants program will help civil society organizations in India further their efforts in improving HIV management and positively impact the care and support for local community members living with HIV.” “At Gilead, we believe that strong community partnerships can have a significant impact in improving the care and support for people living with serious diseases,” said Amy Flood, Senior Vice President, Public Affairs, Gilead Sciences. “Gilead’s Asia Pacific Rainbow Grants program is one way that we work with community groups and support projects that place people at the center of care. We look forward to supporting organizations in the region, to help enable people living with HIV reach their fullest potential each day and live a fulfilling life.” Gilead has expanded the grants program to 18 countries or territories in the region – nearly doubling the geographic scope from last year’s program. More than USD $1 million was awarded to 28 organizations across 10 countries or territories last year. ]]> <![CDATA[Alembic Pharmaceuticals receives USFDA approval for Febuxostat tablets]]> https://biospectrumindia.com/news/95/14083/alembic-pharmaceuticals-receives-usfda-approval-for-febuxostat-tablets.html https://biospectrumindia.com/news/95/14083/alembic-pharmaceuticals-receives-usfda-approval-for-febuxostat-tablets.html Tue, 02 Jul 2019 14:45:00 +0530 Alembic Pharmaceuticals Limited has received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Febuxostat Tablets, 40 mg and 80 mg. The approved ANDA is therapeutically equivalent to the: reference listed drug (RLD), Uloric Tablets, 40 mg and 80 mg, of Takeda Pharmaceuticals U.S.A., Inc. (Takeda). Febuxostat Tablets are xanthine oxidase (XO) inhibitor indicated for the chronic management of hyperuricemia in adult patients with gout who have an inadequate response to a maximally titrated dose of allopurinol, who are intolerant to allopurinol, or for whom treatment with allopurinol is not advisable. Febuxostat Tablets are not recommended for the treatment of asymptomatic hyperuricemia. Febuxostat Tablets have an estimated market size of US$ 578 million for twelve months ending December 2018 according to IQVIA. Alembic had previously received tentative approval for this ANDA. ]]> <![CDATA[Alembic Pharma set to treat seizures with Clonazepam ]]> https://biospectrumindia.com/news/95/14082/alembic-pharma-set-to-treat-seizures-with-clonazepam-.html https://biospectrumindia.com/news/95/14082/alembic-pharma-set-to-treat-seizures-with-clonazepam-.html Tue, 02 Jul 2019 14:30:00 +0530 Alembic Pharmaceuticals Limited has received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Clonazepam Orally Disintegrating Tablets USP, 0.125 mg, 0.25 mg, 0.5 mg, 1 mg and 2 mg. The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Klonopin Orally Disintegrating Tablets, 0. 125 mg, 0.25 mg, 0.5 mg, 1 mg and 2 mg, of Hoffmann-La Roche, Inc. (Roche). Clonazepam orally disintegrating tablet is useful alone or as an adjunct in the treatment of the Lennox-Gastaut syndrome (petit mal variant), akinetic and myoclonic seizures. In patients with absence seizures (petit mal) who have failed to respond to succinimides, clonazepam orally disintegrating tablets may be useful. It is also indicated for the treatment of panic disorder, with or without agoraphobia, as defined in DSMV. Clonazepam Orally Disintegrating Tablets USP has an estimated market size of US$ 20 million for twelve months ending December 2018 according to IQVIA. Alembic now has a total of 98 ANDA approvals (86 final approvals and 12 tentative approvals) from USFDA. ]]> <![CDATA[Cadila Pharma organizes Care with Compassion]]> https://biospectrumindia.com/news/95/14068/cadila-pharma-organizes-care-with-compassion.html https://biospectrumindia.com/news/95/14068/cadila-pharma-organizes-care-with-compassion.html Tue, 02 Jul 2019 09:00:00 +0530 Stressing that Epilepsy is completely curable and there is no need to panic, a group of doctors from Gujarat and Uttar Pradesh took part in a social media campaign to bust the various myths associated with the neurological disorder, and to urge patients to trust modern medicine. The patient awareness campaign Care with Compassion was undertaken by Ahmedabad-based pharma major Cadila Pharmaceuticals and was aimed at creating awareness about Epilepsy and the available treatments. Lack of knowledge of anti-epileptic drugs, poverty, cultural beliefs, stigma, poor health infrastructure, and shortage of trained professionals contribute to the treatment gap, according to experts. As a part of the campaign, Dr Lomesh Bhirud of Surat stressed on the need to take Epilepsy patients to neurologists rather than risking their lives by taking them to Bhuvas. Dr Vishal Jogi of Ahmedabad reiterated that the latest technological advancements have made Epilepsy completely curable. Dr Amit Patanvadiya from Surat emphasized on the need for using proper anti-epileptics to control epileptic attacks. Epilepsy affects 14 people per 1,000 population in India, the majority of them children and young adults, and in rural areas. An estimated 12 million people in India are epileptics. In fact, the country is home to one of every six people suffering from Epilepsy worldwide. What has made Epilepsy a bigger problem than it is a lack of awareness and social stigma attached with the disorder. According to estimates, 60% of the Persons with Epilepsy consult a doctor after suffering a seizure. However, the corresponding number is just 10% in rural areas. Further, a staggering 95% of the people with active Epilepsy do not receive appropriate treatment for their condition, leading to large treatment gap. Dr YC Shah from Ahmedabad spoke about various common myths associated with epilepsy. Dr Kaushik Rana of Vadodara supported the latest research on epilepsy and urged patients and caretakers not to get panicky. Dr. Malay Ghodasara of Rajkot urged patients to avail of modern treatment, and not to opt for traditional rituals for treatment. Doctors from Uttar Pradesh were also roped in for the awareness campaign Dr Ashish Tiwari from Varanasi provide valuable insights into the signs and symptoms of the disease. Dr Arun Kumar Singh from Lucknow reiterated that there was no need to fear Epilepsy anymore. Dr Sanjeev Suri of Kanpur spoke about the various stigmas that surround the disorder, and urged people to treat it like just any other disease. Cadila Pharmaceuticals launched the campaign Care with Compassion last month with doctors coming together to spread awareness around Schizophrenia. The campaign had garnered more than 1 lakh impressions. ]]> <![CDATA[Lupin receives tentative USFDA approval for Mirabegron ER Tablets]]> https://biospectrumindia.com/news/95/14034/lupin-receives-tentative-usfda-approval-for-mirabegron-er-tablets.html https://biospectrumindia.com/news/95/14034/lupin-receives-tentative-usfda-approval-for-mirabegron-er-tablets.html Fri, 28 Jun 2019 11:05:00 +0530 Lupin has announced that it has received tentative approval for its Mirabegron Extended Release (ER) Tablets, 25 mg and 50 mg, from the United States Food and Drug Administration (FDA), to market a generic version of Myrbetriq Extended Release Tablets, 25 mg and 50 mg, of Astellas Pharma Global Development Inc. (Astellas). Lupin’s Mirabegron ER Tablets, 25 mg and 50 mg, is a generic version of Myrbetriq Extended Release Tablets, 25 mg and 50 mg, of Astellas. It is indicated for the treatment of Overactive Bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency.  Mirabegron ER Tablets 25 mg and 50 mg had annual sales of approximately USD 1501.6 mn in the US (IMS MAT March 2019). ]]> <![CDATA[Glenmark receives ANDA approval for Ezetimibe and Simvastatin Tablets]]> https://biospectrumindia.com/news/95/14033/glenmark-receives-anda-approval-for-ezetimibe-and-simvastatin-tablets.html https://biospectrumindia.com/news/95/14033/glenmark-receives-anda-approval-for-ezetimibe-and-simvastatin-tablets.html Fri, 28 Jun 2019 11:00:00 +0530 Glenmark Pharmaceuticals has been granted final approval by the USFDA for Ezetimibe and Simvastatin Tablets, 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg, and 10 mg/80 mg, a generic version of Vytorin Tablets, 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg, and 10 mg/80 mg, of MSD International GmbH. According to IQVIATM sales data for the 12 month period ending April 2019, the Vytorin® Tablets market achieved annual sales of approximately $92.4 million. Glenmark’s current portfolio consists of 157 products authorized for distribution in the U.S. marketplace and 58 ANDA’s pending approval with the USFDA. ]]> <![CDATA[Lupin Foundation organizes Dr. Desh Bandhu Gupta Memorial Lecture]]> https://biospectrumindia.com/news/95/14023/lupin-foundation-organizes-dr-desh-bandhu-gupta-memorial-lecture.html https://biospectrumindia.com/news/95/14023/lupin-foundation-organizes-dr-desh-bandhu-gupta-memorial-lecture.html Fri, 28 Jun 2019 09:00:00 +0530 Lupin Foundation, the CSR arm of Lupin organized a memorial lecture to remember their Founder and Chairman, Dr. Desh Bandhu Gupta on his second death anniversary. The lecture was held at the India International Centre, New Delhi on June 26, 2019. Inaugurated and introduced by Sita Ram Gupta, Executive Director, Lupin Human Welfare & Research Foundation (LHWRF), the event hosted over 200 dignitaries. It was also graced by Sompal Shastri - Former Union Minister for Agriculture; Uma Suresh Prabhu; I.C. Shrivastava - Ex IAS Officer and Ex Collector of Bharatpur District and Yaduvendra Mathur - Special Secretary, NITI Aayog. Sompal Shastri addressed the audience with the first Dr. Desh Bandhu Gupta Memorial Lecture wherein he spoke about the efforts undertaken to overcome rural distress. Speaking on the event Sita Ram Gupta said, “Lupin Foundation today remembers its guiding light Dr. Desh Bandhu Gupta for his philanthropic and pioneering efforts in India’s CSR space. His far-sighted leadership enabled us to touch lives of over 2.8 million people in more than 4371 villages across the country through a growth oriented model of rural development. Our job is not yet over, we will continue to strive hard and keep his vision alive for betterment of rural development.” The Memorial Day also recognized ‘18 Rural Achievers’ who successfully overcame their hurdles and set out to be an example in their communities.   ]]> <![CDATA[Sun Pharma enters into two agreements with China Medical System]]> https://biospectrumindia.com/news/95/14029/sun-pharma-enters-into-two-agreements-with-china-medical-system.html https://biospectrumindia.com/news/95/14029/sun-pharma-enters-into-two-agreements-with-china-medical-system.html Fri, 28 Jun 2019 09:00:00 +0530 Sun Pharmaceutical has announced that one of its wholly owned subsidiaries has entered into two exclusive licensing agreement with a subsidiary of China Medical System Holdings Ltd. (CMS) for the development and commercialization of Cyclosporine A 0.09% (CsA) eye drops, an innovative formulation, for dry eye disease; and for the development and commercialization of Tildrakizumab, an innovative biologic product, for psoriasis and psoriatic arthritis in Greater China (including Mainland China, Hong Kong Special Administrative Region, Macao Special Administrative Region and Taiwan). Under terms of the license agreement, CMS will pay Sun Pharma an initial upfront payment, regulatory and sales milestone payments, and royalties on net sales, the terms of which are confidential. CMS will be responsible for development, regulatory filings and commercialization of the product in China. The initial tenure of the agreement shall be 15 years from the first commercial sale of CsA in Greater China, and may be extended for additional 3 years subject to certain conditions defined in the agreement. Kirti Ganorkar, Executive Vice President and Head, Global Business Development, Sun Pharma said, “We are pleased to enter into a licensing arrangement with CMS, a leading pharmaceutical company in Greater China. Dry Eye disease represents an area of high unmet medical need, with a significant number of patients having moderate to severe form of this disease. Sun Pharma is committed to growing its global ophthalmology franchise, with cyclosporine as its lead product.” Cyclosporine A 0.09% ophthalmic solution (CsA) is a patented, novel, proprietary nanomicellar formulation in a clear, preservative-free, aqueous solution. Dilip Shanghvi, Managing Director, Sun Pharma said, “This licensing agreement marks our entry into the Greater China market which is the second largest pharmaceutical market globally. Sun Pharma is committed to growing its dermatology franchise, with Tildrakizumab as its lead product. We continue to build our pipeline and capabilities in this important therapeutic area of significant unmet need. We are excited to be partnering with a leading pharmaceutical company like CMS to offer Tildrakizumab as an alternative treatment for psoriasis and psoriatic arthritis in Greater China.” Tildrakizumab-asmn is a humanized lgG1/k monoclonal antibody designed to selectively bind to the p19 subunit of interleukin-23 (IL-23) and inhibit its interaction with the IL-23 receptor, leading to inhibition of the release of pro-inflammatory cytokines and chemokines. It was approved by USFDA in March 2018 and is being currently marketed in the US under the ILUMYATM brand name. It is indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. ]]> <![CDATA[Sun Pharma and CMS enter into a License Agreement for Tildrakizumab in Greater China]]> https://biospectrumindia.com/news/95/14030/sun-pharma-and-cms-enter-into-a-license-agreement-for-tildrakizumab-in-greater-china.html https://biospectrumindia.com/news/95/14030/sun-pharma-and-cms-enter-into-a-license-agreement-for-tildrakizumab-in-greater-china.html Thu, 27 Jun 2019 17:10:00 +0530 Sun Pharmaceutical has announced that one of its wholly owned subsidiaries has entered into a licensing agreement with a subsidiary of China Medical System Holdings Ltd. (CMS) for the development and commercialization of Tildrakizumab, an innovative biologic product, for psoriasis and psoriatic arthritis in Greater China (including Mainland China, Hong Kong Special Administrative Region, Macao Special Administrative Region and Taiwan). Under terms of the license agreement, CMS will pay Sun Pharma an initial upfront payment, regulatory and sales milestone payments, and royalties on net sales, the terms of which are confidential. CMS will be responsible for development, regulatory filings and commercialization of the product in China. The initial tenure of the agreement shall be 15 years from the first commercial sale of Tildrakizumab in Greater China, and may be extended for additional 3 years’ subject to certain conditions defined in the agreement.  Dilip Shanghvi, Managing Director, Sun Pharma said, “This licensing agreement marks our entry into the Greater China market which is the second largest pharmaceutical market globally. Sun Pharma is committed to growing its dermatology franchise, with Tildrakizumab as its lead product. We continue to build our pipeline and capabilities in this important therapeutic area of significant unmet need. We are excited to be partnering with a leading pharmaceutical company like CMS to offer Tildrakizumab as an alternative treatment for psoriasis and psoriatic arthritis in Greater China.” Tildrakizumab-asmn is a humanized lgG1/k monoclonal antibody designed to selectively bind to the p19 subunit of interleukin-23 (IL-23) and inhibit its interaction with the IL-23 receptor, leading to inhibition of the release of pro-inflammatory cytokines and chemokines. It was approved by USFDA in March 2018 and is being currently marketed in the US under the ILUMYATM brand name. It is indicated for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. ]]> <![CDATA[Hilleman Lab licenses Oral Cholera Vaccine Hillchol to Bharat Biotech]]> https://biospectrumindia.com/news/95/14010/hilleman-lab-licenses-oral-cholera-vaccine-hillchol-to-bharat-biotech.html https://biospectrumindia.com/news/95/14010/hilleman-lab-licenses-oral-cholera-vaccine-hillchol-to-bharat-biotech.html Wed, 26 Jun 2019 16:55:00 +0530 Hilleman Laboratories, a global research and development organization focused on delivering high-impact and affordable vaccines, has announced that it has entered into a collaboration with Bharat Biotech International Ltd. (BBIL), a leading vaccine and biotechnology company in India for further development, manufacturing and commercialization of its next-generation Oral Cholera Vaccine, Hillchol®.  This collaboration will strengthen the ability of both organizations towards prevention of Cholera through rapid and cost-effective deployment of vaccine doses in low and middle-income countries. Cholera is an acute diarrheal infection caused by Vibrio Cholerae and has been responsible for seven pandemics till date. Cholera is a poverty-related disease, endemic in South Asia and Africa, and is on the WHO priority list. Globally, Cholera accounts for ~2.8 million cases and an estimated 95,000 deaths annually. In India, about 30% of the population - 375 million people - remain at risk. Deployment of oral Cholera vaccines (OCVs) are an essential public health component of comprehensive Cholera prevention and control, recommended by the WHO and an element of its “EndCholera” initiative. Hillchol® was designed at the University of Gothenburg in Sweden and subsequently developed by Hilleman Labs including demonstration of safety and immunogenicity in an age de-escalating Phase I/II clinical trial conducted in Bangladesh with the assistance of icddr,b and Incepta Vaccines Ltd.  Prof. Jan Holmgren, University of Gothenburg who along with his colleague Dr. Michael Lebens and their team invented the vaccine commented, “Hillchol® contains a single recombinant Hikojima strain which expresses both Inaba and Ogawa antigens, resulting in a shorter and simpler manufacturing process as compared to licensed OCVs. Hillchol® will therefore be of great importance and value to help to meet the urgent demands from Cholera afflicted countries for much expanded oral Cholera vaccines manufacturing and supplies for the control of Cholera globally” Speaking about the partnership, Dr. Davinder Gill, Chief Executive Officer, Hilleman Laboratories said, “Vaccines play a critical role in improving healthcare outcomes globally, and Hilleman Laboratories is honoured to work with Bharat Biotech, a leading vaccine manufacturer in India for development, and if licensed, eventual manufacturing and commercialization of our innovative oral Cholera vaccine Hillchol®. Availability of an affordable Cholera vaccine is particularly significant considering that more than 50 GAVI eligible countries have been categorized as Cholera-endemic. We hope this collaboration will provide an innovative vaccine solution which is both affordable and accessible.” Dr. Krishna Ella, Chairman & Managing Director of Bharat Biotech International Limited, said, “We are delighted to lead the scale-up, development, manufacturing and commercialisation efforts for Hillchol®️ with our collaboration marking an important step. Our capacity to deliver 50 million doses per year and the addition of a WHO pre-qualification of Hillchol®️in the future, will not only solve the demand uncertainty but aid in affordability thereby resulting in the wider use of such a vital oral Cholera vaccine worldwide.” Dr. Gerd Zettlmeissl, Chairman, Hilleman Laboratories congratulated both partners on entering into collaboration agreement to align efforts and said “By working together, we can move even closer to meeting the critical public health goal of reducing Cholera burden by 90% by 2030, a key objective of WHO End Cholera initiative” For further development of Hillchol®, Hilleman Labs has entered into a licensing and manufacturing agreement with BBIL, who will scale the manufacturing process to commercial stage and establish product specifications required for WHO pre-qualification.   ]]> <![CDATA[Dr. Reddy's announces the launch of Tobramycin Inhalation Solution ]]> https://biospectrumindia.com/news/95/14002/dr-reddys-announces-the-launch-of-tobramycin-inhalation-solution-.html https://biospectrumindia.com/news/95/14002/dr-reddys-announces-the-launch-of-tobramycin-inhalation-solution-.html Tue, 25 Jun 2019 15:40:00 +0530 Dr. Reddy’s Laboratories has announced the launch of Tobramycin Inhalation Solution, USP a therapeutic equivalent generic version of TOBI® (tobramycin) Inhalation Solution, approved by the U.S. Food and Drug Administration (USFDA).  The TOBI® (tobramycin) Inhalation Solution brand and generic had U.S. sales of approximately $97 million MAT for the most recent twelve months ending in April 2019 according to IQVIA Health. Dr. Reddy’s Tobramycin Inhalation Solution, USP is available in a 300 mg/5 mL, single-dose Ampule. Tobi® is a trademark of Mylan. ]]> <![CDATA[IIL to invest Rs 75 Cr for expanding Karkapatla Plant]]> https://biospectrumindia.com/news/95/13993/iil-to-invest-rs-75-cr-for-expanding-karkapatla-plant.html https://biospectrumindia.com/news/95/13993/iil-to-invest-rs-75-cr-for-expanding-karkapatla-plant.html Mon, 24 Jun 2019 13:55:00 +0530 Indian Immunologicals Ltd (IIL), a leading biologicals company, has announced the ground-breaking of a new Sterile Filling Facility (SFF) at its manufacturing plant in Phase III of Genome Valley, Karkapatla, Ranga Reddy District, Telangana. With this investment of INR 75 crores in the upcoming filling facility, Indian Immunologicals Limited expects to increase its capacity to supply lifesaving vaccines such as the Anti Rabies Vaccine (ARV) – Abhayrab™. The new state-of-the-art facility expected to be ready later next year. The sterile facility is equipped with hi-end filling equipment from the world’s best manufacturers, in line with the requirements of the nature of work handled at the plant. Dr. K. Anand Kumar, Managing Director – Indian Immunologicals Limited said, “IIL has a long history of supplying vaccines critical to public health. We are constantly striving to make the vaccines affordable and accessible to reach the benefits of preventive healthcare to maximum number of people. The expansion at Karkapatla plant is in line with our mission and will help meet the growing requirements of critical vaccines”. Various reports in the past few months indicate that several states in the country have reported shortages of ARV, due to a combination of factors including growing demand, imperfect demand signal, and supply disruptions. Reports indicate that the shortages sometime extend to the tune of 60-80%. “Currently there are reports of shortages of anti-rabies vaccine in the country. Investment in a new sterile filling facility shows that IIL is committed to expanding manufacturing capacity to meet unmet public health needs in India. With supply from this facility, IIL will continue to be the largest rabies vaccine manufacturer in the country,” added Dr. Prasanna Deshpande, Deputy Managing Director, Indian Immunologicals Limited. IIL has 4 manufacturing facilities at various locations – Karkapatla, Telangana – Human Vaccines & Animal Health Formulations; Ooty, Tamil Nadu – Anti Rabies production unit; Hyderabad, Telangana – Human Biologicals Unit (Gachibowli) and animal vaccines unit; Dargaville, New Zealand - New Bovine Serum. IIL exports various Human and animal vaccines to over 50 countries and currently employs around 1,300 people. ]]> <![CDATA[Cadila explores international collaborations to improve healthcare]]> https://biospectrumindia.com/news/95/13989/cadila-explores-international-collaborations-to-improve-healthcare.html https://biospectrumindia.com/news/95/13989/cadila-explores-international-collaborations-to-improve-healthcare.html Mon, 24 Jun 2019 12:50:00 +0530 Cadila Pharmaceuticals, a global leader in the Pharmaceutical Industry, participated in IPHEX 2019, to further enhance its scope by opening new avenues. IPHEX hosted by PHARMEXCIL at the Helipad Ground, Gandhinagar on June 10 brought together buyers from more than 130 countries.Participating in this three-day future-oriented development event of this industry Cadila Pharma, presented its life-science value chain amongst thousands of industry experts, seller, manufacturers and policymakers. Furthermore, the company’s primary capabilities were discussed at this platform to encourage business enquires from over 150 buyers from 50 countries. With a vision to improve business outcomes with collaborative efforts, the exhibition came as a great opportunity for Cadila Pharma, along with those from the farthest corners of India. Representing an offering of customized solutions for every business need, Mr Mahidhwaj Sisodia, Executive Vice President, International Business, said “The Indian healthcare and pharmaceutical industry is at its pinnacle and the demand for finished formulations and APIs is growing. We had one of the busiest stall in IPHEX and received a stellar review and interest by the countries and attendees coming forth. We would like to thank all the delegates and partners for having shown the confidence in the interactions with our team”. Cadila Pharma’s extensive range of finished dosage formulations covers every aspect of human life. We provide affordable innovations that make life better and healthier. Our basket of formulations contains more than 850 products belonging to 45 therapeutic segments and 12 specialties including Anti TB, Cardiovascular, Gastrointestinal, Analgesics, Haematinics, Anti-infectives, Respiratory, Antidiabetics, and Oncology. Their strength area includes contract research facility; discovering unmet medical needs for generics and new chemical entities; synthesizing and exporting high-quality API and intermediaries; finished formulations for multiple therapies and much more. ]]> <![CDATA[Dr. Reddy's announces the launch of Phytonadione Injectable Emulsion USP]]> https://biospectrumindia.com/news/95/13984/dr-reddys-announces-the-launch-of-phytonadione-injectable-emulsion-usp.html https://biospectrumindia.com/news/95/13984/dr-reddys-announces-the-launch-of-phytonadione-injectable-emulsion-usp.html Mon, 24 Jun 2019 11:25:00 +0530 Dr. Reddy’s Laboratories Ltd. has announced the launch of Phytonadione Injectable Emulsion USP, 10 mg/ml Single-Dose Ampules, a therapeutic equivalent generic version of Vitamin K1 (Phytonadione) Injectable Emulsion USP, 10 mg/ml, approved by the U.S. Food and Drug Administration (USFDA). “We’re pleased to bring this product to market for the customers and patients who will benefit from access to this medicine and who have in the past experienced supply disruptions in the market place,” explains Marc Kikuchi, Chief Executive Officer, North America Generics, Dr. Reddy’s Laboratories. “This is a great addition to our injectable offering in the U.S. market as we continue to augment our portfolio to drive growth for the Global Hospitals segment.” The Vitamin K1 (Phytonadione) for Injectable Emulsion USP, 10 mg/ml brand and generic had combined U.S. sales of approximately $46.6 million MAT for the most recent twelve months ending in April 2019 according to IQVIA Health*. Dr. Reddy’s Phytonadione Injectable Emulsion USP, 10 mg/ml Single-Dose Ampules is available in 1 mL Ampule containing 10 mg/mL of Phytonadione. Dr. Reddy’s Laboratories Ltd. is an integrated pharmaceutical company, committed to providing affordable and innovative medicines for healthier lives. Through its three businesses - Pharmaceutical Services & Active Ingredients, Global Generics and Proprietary Products – Dr. Reddy’s offers a portfolio of products and services including APIs, custom pharmaceutical services, generics, biosimilars and differentiated formulations. Our major therapeutic areas of focus are gastrointestinal, cardiovascular, diabetology, oncology, pain management and dermatology. Dr. Reddy’s operates in markets across the globe. Our major markets include – USA, India, Russia & CIS countries, and Europe.  *IQIA Retail and Non-Retail MAT April 2019 RDY-0519-248   ]]> <![CDATA[Piramal invests $10M to expand API capability in U.S.]]> https://biospectrumindia.com/news/95/13965/piramal-invests-10m-to-expand-api-capability-in-u-s-.html https://biospectrumindia.com/news/95/13965/piramal-invests-10m-to-expand-api-capability-in-u-s-.html Fri, 21 Jun 2019 10:05:00 +0530 Piramal Pharma Solutions (PPS), a leading Contract Development and Manufacturing Organization (CDMO) has announced the Grand Opening of a new wing at the Riverview site dedicated to the production of high potency active pharmaceutical ingredients (HPAPIs) with low Occupational Exposure Levels (OELs). The total investment required to upgrade the site was approximately $10 million USD. This includes the new QC/analytical lab and two kilo-labs, as well as a doubling of the office space, which was needed to support the dramatic growth at the Riverview site. Local dignitaries participated in the event, including Riverview Mayor Andrew Swift, Wayne County Executive Warren C. Evans and other officials representing the City of Riverview, Wayne County and Michigan Economic Development Corporation (MEDC).         To date, the Riverview site has had the containment capability and engineering controls to safely handle HPAPIs with OELs down to 1mcg/m3, at scales ranging from grams to ~250 kilos. The new wing, which consists of two kilo-labs and a QC/analytical lab, brings more to the table. It was designed with the required engineering controls and containment solutions to handle HPAPIs with OELs <1mcg/m3 and as low as ~20ng/m3. Materials will primarily be produced in this new wing at kilo-lab scales; lots of <5 kilos can be produced in this new state-of-the-art facility. Vivek Sharma, CEO, Piramal Pharma Solutions said, “We are one of only a few companies in the contract development and manufacturing market that have the capability to produce HPAPIs at such low OELs. It’s another example of how we remain committed to partnering with our customers to serve the patient community and reduce the burden of disease.” Historically, the site operated as one shift, five days a week. Today, the site operates twelve hours a day, seven days a week, and is headed towards being a full 24/7 site. The Riverview site expansion also provides significant benefits to the local economy, including the addition of new high-tech jobs. The local staff has increased from 80 to 127 people, with a projected total of approximately 150 employees in the near future. This includes high-tech staffing of PhD and BS degreed scientists, plus manufacturing operators and other skilled workers. Vince Ammoscato, Vice President and Riverview Site Head, added “This new, enhanced capability opens the site up to a new base of customers, including the antibody drug conjugate (ADC) market. We are equipped to offer ADC customers a seamless end-to-end solution, since we can develop the HPAPI payloads and linkers here in Riverview, send them to our site in Scotland for the antibody conjugation, then back to our Lexington, Kentucky site for sterile fill and finish.” The ability to offer a fully integrated solution for the ADC market – from proof-of-concept studies to conjugation development, clinical and commercial ADC GMP batch manufacturing and fill/finish – represents a significant strategic advantage for Piramal Pharma Solutions. According to Ammoscato, more expansions are forthcoming. There is additional real estate available on the site for added capacity and new capability enhancements that will be designed to match the market needs of the pharmaceutical industry.   ]]> <![CDATA[Cadila Pharma upgrades ETP towards sustainable development]]> https://biospectrumindia.com/news/95/13952/cadila-pharma-upgrades-etp-towards-sustainable-development.html https://biospectrumindia.com/news/95/13952/cadila-pharma-upgrades-etp-towards-sustainable-development.html Fri, 21 Jun 2019 09:00:00 +0530 Cadila Pharmaceuticals Ltd upgrades their Effluent Treatment Plant (ETP) at Dholka to Supervisory Control and Data Acquisition (SCADA), an online monitoring system for the same along with new constructions for chemical treatments and green walkways. After the United Nations declared the Sustainable Development Goals (SDGs), otherwise known as the Global Goals, are a universal call to action, SDG 9 aimed to build resilient infrastructure, sustainable industrialization and SDG6 aimed at clean water and sanitation. Cadila Pharma committed towards the same by up-scaling their Effluent Treatment Plant (ETP) at Dholka to Supervisory Control and Data Acquisition (SCADA), an online monitoring system for the Final Water Analysis. This method will ensure safer treatment of the effluents released while keeping the environment around the production plant, clean. The overhaul also consists of the construction of a neutralization tank, where the chemicals are added for pH correction and effluent subjected to coagulation-flocculation. In addition to this, a process for Clariflocculator, the main clarifying unit which is a secondary treatment unit, both for water as well as wastewater, was established. It was separated from the integrated tank to lead to an aeration tank (existing and newly constructed) to handle the activated sludge.  Along with this, Cadila Pharma installed an advanced filtration with decanter machine in the sludge holding tank which will provide for dry cakes that can be disposed of in an easier and safer manner. A walkway and garden laid out in planned manner to deal with other environment issues.   ]]> <![CDATA[Novo Nordisk’ Victoza gets FDA nod to treat type 2 diabetes]]> https://biospectrumindia.com/news/95/13960/novo-nordisk-victoza-gets-fda-nod-to-treat-type-2-diabetes.html https://biospectrumindia.com/news/95/13960/novo-nordisk-victoza-gets-fda-nod-to-treat-type-2-diabetes.html Thu, 20 Jun 2019 16:25:00 +0530 Novo Nordisk has announced that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for Victoza® (liraglutide) injection to lower blood sugar along with diet and exercise in children and adolescents aged 10-17 years with type 2 diabetes. As the first glucagon-like peptide-1 (GLP-1) receptor agonist approved for children and adolescents with type 2 diabetes, Victoza® provides this population with a new treatment option beyond metformin and insulin for the first time in 19 years. Victoza® was first approved in the U.S. in 2010 as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. The update is based on results from the global ELLIPSE trial, the first phase 3 trial completed in over a decade in children and adolescents with type 2 diabetes. In this study, patients aged 10 to 17 were randomized to receive liraglutide up to 1.8 mg/day or placebo, in combination with metformin with or without basal insulin over a 26-week double-blinded period followed by a 26-week open-label extension period. "We are delighted with the label expansion for Victoza®, which now includes an indication for use in children and adolescents with type 2 diabetes in the U.S. - this is a landmark approval as the first-ever GLP-1 receptor agonist approved for this population," commented Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk. "The prevalence of type 2 diabetes in the U.S. is ever increasing and we are seeing a higher number of diagnoses in children and adolescents, for whom there are limited treatment choices. Victoza® will provide a new option for clinicians treating this challenging disease, helping to address the growing need for this population." ]]> <![CDATA[Gilead collaborates with Nurix to develop new cancer therapies]]> https://biospectrumindia.com/news/95/13959/gilead-collaborates-with-nurix-to-develop-new-cancer-therapies.html https://biospectrumindia.com/news/95/13959/gilead-collaborates-with-nurix-to-develop-new-cancer-therapies.html Thu, 20 Jun 2019 15:50:00 +0530 Gilead Sciences and Nurix Therapeutics, Inc., a company discovering drugs that harness the body’s natural process to control protein levels, today announced a global strategic collaboration to discover, develop and commercialize a pipeline of innovative targeted protein degradation drugs for patients with cancer and other challenging diseases. Dysregulated and/or mutated proteins play a central role in the development and progression of many human diseases. Nurix’s technology platform is focused on the manipulation of the ubiquitin system and its component E3 ligases, the key enzymes responsible for controlling protein levels in human cells. Under the multi-year collaboration, Nurix will utilize its proprietary drug discovery platform to identify novel agents that utilize E3 ligases to induce degradation of specified drug targets and Gilead will have an option to license drug candidates directed to up to five targets resulting from the work. Nurix will retain the option to co-develop and co-detail up to two programs in the United States. The collaboration excludes Nurix’s lead degradation program, for which Nurix retains all rights. “There are many molecular targets involved in disease pathways that have traditionally been challenging to manipulate using conventional approaches,” said John McHutchison, A.O., M.D., Chief Scientific Officer and Head of Research and Development, Gilead Sciences. “Nurix’s innovative protein degradation discovery technology provides Gilead with a new strategy to interrogate these drug targets, as we continue to build a pipeline of small molecule therapeutics for patients with cancers and other diseases.” “Gilead is an ideal partner to help us bring potentially transformative treatments to patients,” said Arthur T. Sands, M.D., Ph.D., Nurix’s Chief Executive Officer. “This partnership expands our ability to build our pipeline of novel targeted protein degradation drugs based on our established expertise in the field of protein homeostasis, while we continue to independently advance our lead programs into the clinic.” Under the terms of the agreement, Nurix will receive an upfront payment of $45 million and will be eligible to receive up to approximately $2.3 billion in total additional payments based on the successful completion of certain research, pre-clinical, clinical, regulatory and commercialization milestones as well as up to low double-digit tiered royalties on net sales. For those programs that Nurix opts in to co-develop and co-detail, the parties will split development costs as well as profits and losses 50/50 for the U.S., and Nurix will be eligible to receive royalties on ex-U.S. sales and reduced milestone payments. ]]> <![CDATA[Glenmark receives tentative ANDA approval for Clindamycin Phosphate Foam, 1%]]> https://biospectrumindia.com/news/95/13953/glenmark-receives-tentative-anda-approval-for-clindamycin-phosphate-foam-1.html https://biospectrumindia.com/news/95/13953/glenmark-receives-tentative-anda-approval-for-clindamycin-phosphate-foam-1.html Thu, 20 Jun 2019 10:20:00 +0530 Glenmark Pharmaceuticals has been granted tentative approval by the United States Food & Drug Administration for Clindamycin Phosphate Foam, 1%, a generic version of EVOCLIN® Foam, 1%, of Mylan Pharmaceuticals Inc. According to IQVIATM sales data for the 12 month period ending April 2019, the EVOCLIN® Foam, 1% market achieved annual sales of approximately $17.0 million. Glenmark’s current portfolio consists of 156 products authorized for distribution in the U.S. marketplace and 59 ANDA’s pending approval with the USFDA. ]]> <![CDATA[Cognizant to acquire Zenith Technologies]]> https://biospectrumindia.com/news/95/13947/cognizant-to-acquire-zenith-technologies.html https://biospectrumindia.com/news/95/13947/cognizant-to-acquire-zenith-technologies.html Wed, 19 Jun 2019 16:10:00 +0530 Cognizant has agreed to acquire Zenith Technologies, a privately-held life sciences manufacturing technology Services Company. Zenith Technologies specializes in implementing digital technologies to manage, control and optimize drug and medical device production for maximum operational efficiency and regulatory compliance.  The acquisition extends Cognizant's capabilities for designing, implementing and managing end-to-end operational and information technology systems for connected biopharmaceutical and medical device manufacturers.  Interconnected "smart factories" have become a strategic priority for the industry, with production systems and processes becoming more complex because of research advances and increased demand for large-molecule biologics.  The combined Cognizant-Zenith Technologies expertise will deliver a range of Industry 4.0 capabilities, from factory design consultation, machine sensor and controller instrumentation, supervisory control, and data acquisition, to manufacturing execution systems, batch automation, enterprise resource planning integration and managed services.  The company's operating hubs in Ireland, Germany, India, Singapore, the United States and other sites around the world are located near manufacturing facilities of many Cognizant clients. Cognizant is a leading services provider to the life sciences industry, working with all of the world's top 30 life sciences companies. "Industry 4.0 solutions, encompassing Internet of Things (IoT), automation and analytics, are a strategic focus area for Cognizant," said Brian Humphries, Chief Executive Officer, Cognizant. "In acquiring Zenith Technologies, we expand Cognizant's IoT portfolio and extend our life sciences domain expertise by becoming a single-source provider of end-to-end smart factory capabilities.  Together, we are better positioned to help clients realize information and operational technology convergence in their manufacturing operations, and advance the development of life-saving drugs, biologics, specialized pharmaceuticals and medical devices. We look forward to welcoming Zenith Technologies' employees to Cognizant." "In joining Cognizant, we are bringing together two respected life sciences service provider brands with complementary technology and manufacturing operations expertise," said Joe Haugh, Chief Executive Officer, Zenith Technologies. "It's an exciting time for us, with the life sciences industry embracing digital transformation to enable more flexible and efficient manufacturing facilities to bring new treatments to market faster. Our combined business will drive process excellence through tighter integration of manufacturing processes and systems, the efficient harnessing of information and analytics across the manufacturing value chain, and the adoption of IoT technologies delivering manufacturing 4.0. Together, we are well-positioned to help clients more efficiently produce the life-changing medicines and medical devices for patients who need them most."   The transaction is expected to close in the third quarter of 2019, subject to satisfaction of closing conditions, including regulatory review. Financial details were not disclosed.  ]]> <![CDATA[Piramal Pharma Solutions recognized by Frost & Sullivan for its end-to-end Integrated services ]]> https://biospectrumindia.com/news/95/13941/piramal-pharma-solutions-recognized-by-frost-sullivan-for-its-end-to-end-integrated-services-.html https://biospectrumindia.com/news/95/13941/piramal-pharma-solutions-recognized-by-frost-sullivan-for-its-end-to-end-integrated-services-.html Wed, 19 Jun 2019 14:45:00 +0530 Based on its recent analysis of the contract development and manufacturing organization market, Frost & Sullivan recognized Piramal Pharma Solutions ('PPS', 'the business') with the 2019 Global Customer Service Leadership Award. Through its 12 development centers and manufacturing sites across North America, Europe, and Asia, PPS provides end-to-end capabilities to its pharmaceutical customers across the entire drug development life cycle. It combines its global operational capabilities and standardized scheduling to minimize supply chain constraints and shorten delivery timelines for customers. The business also deploys an innovative quality framework across its global manufacturing network. "With unparalleled research and development (R&D) focus, PPS strives to re-engineer its internal capabilities, programs, and new technologies to expedite a drug's time-to-market," said Khushbu Jain, Industry Analyst at Frost & Sullivan. "PPS' offerings include drug discovery, drug development, and drug substance and product commercial manufacturing. By having half of its manufacturing sites in the East and the other half in the West, it ensures flexible scheduling for shorter delivery timelines and significant resource and time savings." PPS' R&D team resolves complex process development and formulation challenges and develops robust processes for customers. The business has proven expertise in injectable capabilities and provides complete contract development and manufacturing capabilities across active pharmaceutical ingredients (API) and formulations, including niche capabilities in handling cytotoxic injectables, hormonal formulations, and high potency APIs (HPAPIs). In October 2018, PPS announced the launch of its 'Xcelerate Integrated Solutions platform, addressing the growing industry need for preferred collaboration with service providers that can provide world-class solutions across the entire drug-cycle. This platform offers customized solutions through which its customers can accelerate their programs from clinical through approval and launch for both large volume indications and niche fast-track medicines. In addition, as one of the world leaders in the antibody drug conjugates (ADC) segment, the business provides integrated ADC manufacturing solutions ranging from development through clinical and commercial batch manufacturing to ADC fill/finish. PPS is also involved in the supply of commercial ADCs on the market and is working on several Phase II and Phase III drugs designated as breakthrough therapies with multiple pharmaceutical companies. "With a focus on compliance, quality standards, and reliability, PPS cleared 33 United States Food and Drug Administration (US FDA) inspections, 143 other regulatory inspections including by authorities from Europe, Canada, Brazil and Japan, and 971 customer audits across all its facilities without closing production," noted Jain. "Strengthening its value proposition for pharma and biotech companies, PPS is building new capabilities in outsourcing, as well as strategic partnerships with customers. Its inorganic growth strategies and on-going investments at sites allow it to address key customer requirements and ultimately, position itself for greater growth." Vivek Sharma, CEO, Piramal Pharma Solutions said, "We are delighted to receive this award from Frost & Sullivan, one of the industry's most credible companies, for quality recognition. At Piramal Pharma Solutions, we are committed to serving our customers and through them, the patients, with the highest standards of quality. This recognition is a validation of our commitment to be an integrated solutions provider for our customers, and our robust track record. We continue to be the 'Partner of Choice' for global pharmaceutical companies as we continue to invest in capacities and capabilities across our manufacturing and R&D Sites. We remain committed to partnering with our customers to serve the patient community and to reduce the burden of disease." Each year, Frost & Sullivan presents this award to the company that maintains consistently high standards for customer service quality that result in trusted and strategic relationships. PPS is recognized as a company that leverages customer feedback, demonstrates superior speed/timeliness, ensures frictionless interaction and outstanding price/performance value, offers a rich customer purchase/ownership experience, thus raising its overall brand equity. Frost & Sullivan Best Practices awards recognize companies in a variety of regional and global markets for demonstrating outstanding achievement and superior performance in areas such as leadership, technological innovation, customer service, and strategic product development. Industry analysts compare market participants and measure performance through in-depth interviews, analysis, and extensive secondary research to identify best practices in the industry. Piramal Pharma Solutions is a contract development and manufacturing organization (CDMO), offering end-to-end development and manufacturing solutions across the drug life cycle. ]]> <![CDATA[Zydus’ Nesher Pharma gets final USFDA nod for Lovaza capsules ]]> https://biospectrumindia.com/news/95/13916/zydus-nesher-pharma-gets-final-usfda-nod-for-lovaza-capsules-.html https://biospectrumindia.com/news/95/13916/zydus-nesher-pharma-gets-final-usfda-nod-for-lovaza-capsules-.html Mon, 17 Jun 2019 14:20:00 +0530 Zydus’ Nesher Pharmaceuticals, a subsidiary of Zydus Pharmaceuticals USA has received the final approval from the USFDA to market Omega-3-Acid Ethyl Esters Capsules USP (US RLD – Lovaza Capsules), 1 gram. Omega-3 acid ethyl esters, a type of fat found in fish oil, is used along with diet and exercise to help lower levels of a certain blood fat (triglyceride). It may also raise good cholesterol (HDL). The drug will be manufactured at Nesher Pharmaceuticals’ manufacturing facility located at St. Louis, MO, USA. The group now has 267 approvals and has so far filed over 360 ANDAs since the commencement of the filing process in FY 2003-04. ]]> <![CDATA[USFDA grants NAI to Centaur Pharma’s FD facility in Pune]]> https://biospectrumindia.com/news/95/13899/usfda-grants-nai-to-centaur-pharmas-fd-facility-in-pune.html https://biospectrumindia.com/news/95/13899/usfda-grants-nai-to-centaur-pharmas-fd-facility-in-pune.html Mon, 17 Jun 2019 09:00:00 +0530 Mumbai based Centaur Pharmaceuticals' finished dosage facility in Pune was audited by the USFDA in May 2019 and the audit was concluded with NIL 483 observations. The company received No Action Indicated (NAI) compliance status with zero 483 observations from the USFDA which signifies compliance and conformance to applicable cGMP regulations According to Mr. S.D Sawant, Managing Director, Centaur Pharmaceuticals “The NAI is a significant development not only for Centaur but also for the Indian pharmaceutical industry, considering the increasing global regulatory headwinds in the last few years.” In addition to USFDA accreditation, the said facility also conforms to MHRA (UK), TGA (Australia), Health Canada, MCC (South Africa) and WHO-GMP standards. If the investigating officer observes conditions which in his or her judgment are violations of the Food Drug and Cosmetic (FD&C) Act or related acts, then he or she may issue the concerned firm an FDA Form 483. On the other hand, an inspection results in a NAI inspection classification when the inspection either reveals no objectionable conditions or that the significance of the documented objections does not warrant further action.  This classification signifies the compliance status of the concerned establishment at the time of inspection, based on the recorded observations. “The conclusions of the inspection are reported as No Action Indicated (NAI) which is vindication of Centaur’s efforts over the past 40 years in ensuring quality and maintaining international standards across the pharmaceutical value chain in API, formulations, clinical research and contract manufacturing” says Dr. Jayashing Sawant, President- Technical, Centaur Pharmaceuticals. Centaur is also India’s largest and the world’s third largest manufacturer of psychotropic API with state of the art facility conforming to USFDA, EUGMP/ANSM (France), TGA, PMDA (Japan), KFDA (Korea), ANVISA (Brazil), COFEPRIS (Mexico) and WHO-GMP standards. Centaur’s API (Active Pharmaceuticals Ingredients) formulations plant situated in Ambernath, Maharashtra is also an US FDA approved plant. In addition, Centaur Pharmaceuticals also has two world class formulations facilities in Goa which are WHO-GMP approved. ]]> <![CDATA[Sun Pharma’s ILUMYA improves joint and skin symptoms of Psoriatic Arthritis]]> https://biospectrumindia.com/news/95/13896/sun-pharmas-ilumya-improves-joint-and-skin-symptoms-of-psoriatic-arthritis.html https://biospectrumindia.com/news/95/13896/sun-pharmas-ilumya-improves-joint-and-skin-symptoms-of-psoriatic-arthritis.html Fri, 14 Jun 2019 14:55:00 +0530 Sun Pharmaceutical Industries Ltd. recently announced interim results from a Phase 2 study of interleukin-23 (IL-23) inhibitor ILUMYA™ (tildrakizumab-asmn) in patients with active psoriatic arthritis that was presented in a late-breaking oral presentation at the Annual European Congress of Rheumatology (EULAR 2019) in Madrid, Spain.  The interim analysis revealed that over 71 percent of patients treated with ILUMYA™ experienced a 20 percent improvement in joint and skin symptoms (ACR20), meeting the primary endpoint of the study. The interim results showed ILUMYA™ was well tolerated with a low rate of serious treatment-emergent adverse events. ILUMYA™ is approved in the U.S. for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy and is being investigated for psoriatic arthritis. Psoriatic arthritis, which affects up to 42 percent of people with plaque psoriasis, is an inflammatory condition that impacts both the joints and skin. It is painful, causes fatigue, and can lead to swelling and stiffness of the joints that may reduce range of motion. If left untreated, this chronic condition can lead to permanent joint damage. The Phase 2 study interim results showed that across all patients receiving ILUMYA™, 75.3 percent experienced a 20 percent improvement in symptoms of psoriatic arthritis (ACR20) at week 24 compared to 50.6 percent of patients on placebo. The findings were similar in patients receiving 100 mg or 200 mg of ILUMYA™ on a quarterly dosing schedule. For some patients on 100 mg ILUMYA™, results were seen as early as 8 weeks. Furthermore, an average of 47.1 percent of all patients receiving ILUMYA™ achieved an ACR50 response with some results seen as early as 12 weeks, compared to 24.1 percent of patients on placebo. The interim results also showed ILUMYA™ was well tolerated with a low and comparable rate of adverse events to placebo. Serious treatment-emergent adverse events occurred in 2.2 percent of patients treated with ILUMYA™ and 2.5 percent in those on placebo, with no patients discontinuing treatment due to these events. The most common adverse events through week 24 included common cold (nasopharyngitis), upper respiratory tract infection, and headache. There were no reports of candidiasis, inflammatory bowel disease, major adverse cardiac events, malignancy, or deaths. ]]> <![CDATA[Dr. Reddy's enters into a definitive agreement to sell its neurology branded products to Upsher Smith Laboratories]]> https://biospectrumindia.com/news/95/13895/dr-reddys-enters-into-a-definitive-agreement-to-sell-its-neurology-branded-products-to-upsher-smith-laboratories.html https://biospectrumindia.com/news/95/13895/dr-reddys-enters-into-a-definitive-agreement-to-sell-its-neurology-branded-products-to-upsher-smith-laboratories.html Fri, 14 Jun 2019 14:45:00 +0530 Dr. Reddy’s Laboratories Limited has announced that it has  entered into a definitive asset purchase agreement with Upsher-Smith Laboratories pursuant to which Dr. Reddy’s would sell its US and select territory rights for ZEMBRACE SYMTOUCH (sumatriptan injection) 3 mg and TOSYMRA (sumatriptan nasal spray) 10 mg (formerly referred to as “DFN-02”), which are commercialized through its wholly owned subsidiary, Promius Pharma, LLC. Under the agreement, Dr. Reddy’s will receive U.S.$70 million as upfront consideration, U.S.$40.5 million in near term milestones and additional financial considerations including existing contractual obligation and inventory. Subsequently, Dr. Reddy’s will receive sales based royalties on a quarterly basis. The closing of the transaction is subject to various customary closing conditions including antitrust review under Hart-Scott-Rodino Act. “This is a testament to our strong R&D capabilities, and delivering solutions to unmet needs of patients. In a short time, we created a well-recognized migraine specialty business in the US and we look forward to our partnership with Upsher-Smith,” said G.V. Prasad, Co-Chairman and CEO, Dr. Reddy’s Laboratories Limited. “Tosymra and Zembrace were designed and developed with the goal of addressing unmet needs of large but discrete segments of patients suffering from episodic migraine who need options other than their current therapies. We are excited to partner with Upsher-Smith, which has established a strong presence in neurology,” said Anil Namboodiripad, Ph.D., Senior Vice President, Proprietary Products and Head, Promius Pharma.   ]]> <![CDATA[Dr. Reddy’s to sell its neurology products to Upsher-Smith Labs]]> https://biospectrumindia.com/news/95/13891/dr-reddys-to-sell-its-neurology-products-to-upsher-smith-labs.html https://biospectrumindia.com/news/95/13891/dr-reddys-to-sell-its-neurology-products-to-upsher-smith-labs.html Fri, 14 Jun 2019 11:35:00 +0530 Dr. Reddy’s Laboratories Limited announces that it has entered into a definitive asset purchase agreement with Upsher-Smith Laboratories, LLC (Upsher-Smith), pursuant to which Dr. Reddy’s would sell its US and select territory rights for ZEMBRACE® SYMTOUCH® (sumatriptan injection) 3 mg and TOSYMRATM (sumatriptan nasal spray) 10 mg, (formerly referred to as “DFN-02”), which are commercialized through its wholly owned subsidiary, Promius Pharma, LLC.   Under the agreement, Dr.Reddy’s will receive U.S.$70 million as upfront consideration, U.S.$40.5 million in near term milestones and additional financial considerations including, existing contractual obligation and inventory.  Subsequently, Dr. Reddy’s will receive sales based royalties on a quarterly basis.  The closing of the transaction is subject to various customary closing conditions including antitrust review under Hart-Scott-Rodino Act.  “This is a testament to our strong R&D capabilities, and delivering solutions to unmet needs of patients. In a short time, we created a well-recognized migraine specialty business in the US and we look forward to our partnership with Upsher-Smith” said G.V. Prasad, Co-Chairman and CEO, Dr. Reddy’s Laboratories Limited.  “Tosymra and Zembrace were designed and developed with the goal of addressing unmet needs of large but discrete segments of patients suffering from episodic migraine who need options other than their current therapies.  We are excited to partner with Upsher-Smith which has established a strong presence in neurology” said Anil Namboodiripad, Ph.D., Senior Vice President, Proprietary Products and Head, Promius Pharma. ]]> <![CDATA[Lupin positions itself to enter sterile injectables category ]]> https://biospectrumindia.com/news/95/13883/lupin-positions-itself-to-enter-sterile-injectables-category-.html https://biospectrumindia.com/news/95/13883/lupin-positions-itself-to-enter-sterile-injectables-category-.html Thu, 13 Jun 2019 12:35:00 +0530 With flexibility in both the operation and supply chain, Mumbai based multi national pharmaceutical company Lupin is now well-positioned to make their entry into the sterile injectable product category in a unique ready-to-use platform. The injectables facility at Nagpur got commissioned in 2018. In total, Lupin has 18 manufacturing and 9 R&D sites across the globe. The manufacturing capabilities are spread across tablets, capsules, sterile and non-sterile liquids, injectable, metered dose inhalers (MDIs) and dry powder inhalers (DPIs). The new injectable facility in Nagpur manufactures prefilled syringes, and liquids, as well as lyophilized vials, single dose auto injectors, multi-dose pen devices, lyophilized vials. Barrier isolation technology provides the enhanced containment solution during aseptic processing, and novel technologies are considered for automation of component tub and tray debagging and delidding facilitates a no-touch transfer and handling. Exhibit batches of 3 products have been taken for advanced market from the Nagpur facility. The facility has aseptic isolators (from Skan) worth Rs 20 crore installed for prefilled syringe and vials filling. The lyophilizer (from Telstar) is equipped with an automatic vial loading and unloading system and minimized human intervention during the lyophilization to prevent product contamination and increases the lifespan of sensitive products. There is presence of fully automated line for syringe packing with latest technology of Denesting, Plunger Rod insertion, safety device insertion and Blister packaging, along with fully automated assembly machines for auto Injectors and pen devices from M/s Bosch – Moeller Devicon. "We will be very soon conducting biosimilar filling also at our Nagpur facility. Besides the injectables facility, Lupin also has two blocks of Oral Solid Dosage (OSD) facility here in Nagpur. There is an investment of Rs 489 crore involved in the OSD units and Rs 264 crore for the injectables facility. The second OSD block is Lupin's most recent one and the first commercial batch was released in May 2019. We have applied new-age technologies at our Nagpur facility in order to meet our business goals", said Rajendra B. Chunodkar, President – Manufacturing Operations, Lupin.  At present, Lupin has 6-7 biosimilars in the pipeline along with six-times expansion plans at the biosimilar facility in Pune. ]]> <![CDATA[Merck to Acquire Tilos Therapeutics]]> https://biospectrumindia.com/news/95/13868/merck-to-acquire-tilos-therapeutics.html https://biospectrumindia.com/news/95/13868/merck-to-acquire-tilos-therapeutics.html Tue, 11 Jun 2019 15:45:00 +0530 Merck known as MSD outside the United States and Canada has announced that it has entered into a definitive agreement to acquire Tilos Therapeutics, a privately held biopharmaceutical company developing therapeutics targeting the latent TGFβ complex for the treatment of cancer, fibrosis and autoimmune diseases. Dr. Dean Li, senior vice president, discovery and translational medicine, Merck Research Laboratories said, “At Merck we continue to enhance our robust pipeline through active execution of our business development strategy. Tilos has developed a compelling portfolio of candidates that employ a novel approach to modulating the potent signaling molecule TGFβ by binding to latency-associated peptide, with potential applications across a range of disease indications.” Under the terms of the agreement, Merck, through a subsidiary, will acquire all outstanding shares of Tilos for total potential consideration of up to $773 million, including an upfront payment as well as contingent milestone payments. Dr. Barbara Fox, CEO, Tilos said, “We are proud that the Tilos team has advanced the discoveries of our scientific founders by developing a portfolio of anti-LAP antibodies designed to realize the full potential of TGFβ-modulating therapeutics. This agreement with Merck, an industry leader in biopharmaceutical research and development, provides meaningful validation for our therapeutic approach and best positions our pipeline for broad clinical and commercial success.” Tilos was founded by Boehringer Ingelheim Venture Fund and Partners Innovation Fund, based on discoveries by the laboratory of Dr. Howard Weiner at Brigham and Women’s Hospital and Harvard Medical School. Additional investment was provided by ShangPharma Innovation Fund. TGFβ is a potent cytokine believed to play an important role in the development of cancer and fibrotic diseases. TGFβ is secreted as a complex with the protein, latency-associated peptide (LAP). LAP forms a cage around TGFβ, holding the cytokine in an inactive state until it is deployed. Evidence has shown that anti-LAP antibodies block the release of TGFβ from the TGFβ-LAP complex with the potential to provide a novel therapeutic mechanism to reduce TGFβ activity.   ]]> <![CDATA[IPHEX 2019 mega pharma show opens in Gandhinagar]]> https://biospectrumindia.com/news/95/13852/iphex-2019-mega-pharma-show-opens-in-gandhinagar.html https://biospectrumindia.com/news/95/13852/iphex-2019-mega-pharma-show-opens-in-gandhinagar.html Mon, 10 Jun 2019 14:55:00 +0530 Gujarat is set to be the Hub of Indian Pharma Sector. Speaking at the inauguration, Gujarat Chief Minister, Shri Vijay Rupani welcomed over 650 overseas pharma buyers and Government delegates to Gujarat and invited the Indian Pharma sector to consider Gujarat for their future investment plans. Shri Vijay Rupani said, “I am pleased to note that global buyers from over 130 countries are today with us to source quality pharmaceuticals from India. India is a well-recognized quality manufacturer of generics and formulations and their visit to IPHEX will enable them procure their requirements from 350 + exhibitors present at the show.” “Gujarat welcomes investments from all Indian large and SME enterprises and will facilitate collaborative partnerships with overseas companies keen to invest in India,” added, Shri Rupani. Shri Udaya Bhaskar, Director General, The Pharmaceuticals Export Promotion Council of India (PHARMEXCIL) said, ”IPHEX is our flagship event and this edition is the largest ever. Indian pharma exports are current at USD 19.15 billion and more than 50% are exported to highly regulated markets. We expect Industry to benefit from overseas buyer meetings at IPHEX. We are focusing on emerging markets of Latin America, Africa, CIS and ASEAN at IPHEX. Shri Udaya Bhaskar thanked Ministry of Commerce, Govt of India for their support for IPHEX 2019. Shri Vijay Shah, Chairman IPHEX 2019 said, “IPHEX 2019 is India’s Pharma Market place for Global Buyers and Industry will see mega dividends in coming times.” iPHEX is an exhibition that brings together the drugs, pharmaceutical and healthcare industry – all under one roof. It is one of the largest showcases of Indian pharmaceutical products and technologies to a global audience. It offers the industry majors from India and all across the world a great platform to network and grow their businesses.  PHARMEXCIL is the nodal agency to represent Drugs, Pharmaceutical & Healthcare industry in the global arena. With over 3500 members, PHARMEXCIL is mandated to help them achieve excellence in exports and facilitate overseas buyers to find suitable trade partners from the Indian pharma industry.  PHARMEXCIL acts as a single contact point for the overseas buyers and investors by providing a list of manufacturers/exporters of the Pharma Products of interest to them, provide assistance in coordinating appointments for the overseas buyers/investors during their visits to India through its offices at Hyderabad, Mumbai and New Delhi. PHARMEXCIL arranges for visits to manufacturing facilities, research institutes and meetings for overseas buyers with the exporting community for mutual exchange of ideas and information. ]]> <![CDATA[PharmaLytica 2019 set for an impressive debut in Mumbai]]> https://biospectrumindia.com/news/95/13847/pharmalytica-2019-set-for-an-impressive-debut-in-mumbai.html https://biospectrumindia.com/news/95/13847/pharmalytica-2019-set-for-an-impressive-debut-in-mumbai.html Mon, 10 Jun 2019 12:45:00 +0530 UBM India, organizers of CPhI / P-MEC India, the leading global pharma trade show and conference, has announced the 6th edition of the PharmaLytica expo. Formerly a two-day event, Pharmalytica 2019 is a comprehensive three-day show starting from June10-12, 2019 at the Bombay Exhibition Center, Mumbai. The reputed pharma related expo seeks to leverage the opportunities provided by the impressive pharma hub in West India, while also being in close proximity to the South Indian market. The expo enables the pharmaceutical community to pick up on the latest industry trends, innovations and conduct business with Analytical, Laboratory, Machinery, Packaging, Pharma ingredients and other allied Industries. The expo is well supported by associations including Pharmexcil, Confederation of Indian Pharmaceutical Industry (CiPi) and Indian Drug Manufacturers’ Association ( IDMA ). In the current edition, PharmaLytica is about to witness the participation of over 300 exhibitors from across the country including notable industry players, many of whom are making their maiden showcasing at Pharmalytica. Some of the exhibitors include Elmach Packages, Shimadzu, Dockweiler AG, Micronclean, Rotarex, Bruker India Scientific, Sartorius, Schott Kaisha, Gattefosse, Perkin Elmer; Thermolab Scientific Equipments, Nicomac Cleanrooms, Mack Pharmatech, Gangwal Chemicals; Kirloskar Pneumatic, Swati Spentose, Borosil Glass Works, Accupack Engineering, NPM Machinery, Toshvin Analytical, Spinco Biotech, Scientific Research Instruments, LP Global, Bitzer India and Anton Paar among others. With country participation from Luxembourg, United Kingdom, Germany and China, as well as state presence from Maharashtra, Gujarat, Andhra Pradesh, Telangana, Punjab, Haryana, Tamil Nadu, Delhi and Uttarakand,  PharmaLytica is well on its way to becoming a truly pan-India congregation that reaches out to all major Industry sectors and Pharma Hubs. This year, there will be special pavilions dedicated to Pharma Machinery & Packaging; Lab Analytical & Cleanroom and API’s & Excipients Pavilion. To enhance the touch-and-feel aspect of the expo, one of the much-anticipated highlights will be the inclusion of Exhibitor Showcase, where visitors can attend featured presentations, hear best of case studies around innovations and technologies trending within the Pharma marketplace. Exclusive B2B Meeting Area and Customer Insight Lounge will also be organised to connect buyers and sellers, enhance the ease of doing business as well as to increase sectoral insights.  Among other notable showcases, India’s top academic institution IIT Powai, Bombay, Mumbai will exhibit its State of Art Analytical Lab - the Sophisticated Analytical Instrument Facility (SAIF). The facility was originally established at the Indian Institute of Technology, Bombay, in the year 1976, with the support of the Department of Science & Technology, Government of India, New Delhi.  Speaking on the announcement of the 6th edition of PharmaLytica, Mr. Yogesh Mudras, Managing Director, UBM India said, “Over the years, PharmaLytica has evolved as the leading marketplace for products and services along the entire value chain in niche segments within the Pharma industry. This year, we are delighted to move the expo to Mumbai to leverage the proliferating pharma hub of West India in addition to the Southern market. Meanwhile, with our rich legacy of knowledge sharing in the South, I am also pleased to announce the separate launch of PharmaLytica Confex on August 8-9 in Hyderabad. Cumulatively, the PharmaLytica brand seeks to deepen understanding of the changing landscape in the sector to enable strategically sound responses to marketplace trends. It will also play a key role in establishing a unique drug safety ecosystem in India”.“By 2020, India is likely to be among the top three pharmaceutical markets by incremental growth and the 6th largest market globally in absolute size. The pharma companies are making tremendous efforts to discover new drugs, increasing R&D expenditure, implementing technology and introducing new methodologies to improve quality of manufacturing. Our focus at PharmaLytica, would be to keep the companies abreast with innovations in the growing businesses of India’s pharma industry,” he further added.India enjoys an important position in the global pharmaceuticals sector and the largest provider of generic drugs globally. The country’s pharmaceutical industry is expected to expand at a CAGR of 22.4 per cent over 2015–20 to reach US$ 55 billion. India’s pharmaceutical exports stood at US$ 17.27 billion in FY18 and have reached US$ 15.52 billion in FY19 (up to January 2019). The various economic drivers and government policies like pharma parks, allowing 100 per cent FDI, boosting the biosimilars and biologics sector, along with ancillary sectors, and reducing manufacturing costs are the key driving factors for the growth of the sector in the country. The ‘Pharma Vision 2020', introduced to make India a global leader in end-to-end drug manufacturing, has also boosted investments.  ]]> <![CDATA[FDA approves Elli Lilly’s Emgality® (galcanezumab-gnlm) for Episodic Cluster Headache ]]> https://biospectrumindia.com/news/95/13837/fda-approves-elli-lillys-emgality-galcanezumab-gnlm-for-episodic-cluster-headache-.html https://biospectrumindia.com/news/95/13837/fda-approves-elli-lillys-emgality-galcanezumab-gnlm-for-episodic-cluster-headache-.html Fri, 07 Jun 2019 15:50:00 +0530 Eli Lilly and Company has announced that the U.S. Food and Drug Administration (FDA) has approved Emgality®(galcanezumab-gnlm) injection (300 mg) for the treatment of episodic cluster headache in adults. Emgality is an innovative therapeutic approach for this neurologic disease and the first and only calcitonin gene-related peptide (CGRP) antibody approved by the FDA for two distinct headache disorders.1 After training by a healthcare professional, patients can administer Emgality at home through subcutaneous injections at the onset of a cluster headache period, and then monthly until the end of a cluster period. Emgality was first approved by the FDA in September 2018 for the preventive treatment of migraine in adults and is contraindicated in patients with serious hypersensitivity to galcanezumab-gnlm or to any of the excipients. Christi Shaw, president, Lilly Bio-Medicines said, "Episodic cluster headache can be devastating. The approval of Emgality for the treatment of episodic cluster headache is an important milestone as it provides a new treatment option, which has been long-awaited by those impacted by this disease.” Cluster headache is characterized by the abrupt onset of severe to very severe pain on one side of the head. Pain is felt in the orbital, supraorbital, and/or temporal regions (around or above the eye and/or temple) and can be accompanied by symptoms on the same side of the body: conjunctival injection (eye redness), lacrimation (tearing), nasal congestion, rhinorrhea (runny nose), forehead and facial sweating, miosis (constriction of the pupil), ptosis (drooping eyelid) and/or eyelid edema (swollen eyelid), and/or restlessness or agitation. Cluster headache, although severely crippling, is challenging to diagnose because of limited awareness and, for some, may take five years or more to diagnose on average. It has been historically challenging to conduct clinical trials that identify treatment options that help reduce the frequency of attacks for those with episodic cluster headache. During a cluster period, which usually spans two weeks to three months, attacks last 15 to 180 minutes and can occur from once every other day to eight times per day.2People with episodic cluster headache represent 85 to 90 percent of cluster headache prevalence, with approximately 250,000 adults living with this disease in the U.S.  Bob Wold, founder, Clusterbusters, Inc said, "As someone impacted by cluster headache and an advocate for others living with this disease, I know firsthand the desperation that we have felt for additional treatment options that can reduce the frequency of these attacks that have such a debilitating impact on our lives. The approval of Emgality for the treatment of episodic cluster headache is a cause for celebration and hope. On behalf of this community, we thank the FDA, Lilly, the researchers and the patients who helped to usher forward this innovative treatment." Overall, the safety profile observed in patients with episodic cluster headache treated with Emgality 300 mg monthly is consistent with the safety profile in patients with migraine treated with Emgality 120 mg monthly. Two Emgality-treated patients discontinued double-blind treatment during the episodic cluster headache study because of adverse events. David Kudrow, M.D., director, California Medical Clinic for Headache said, "For years, there have been few therapeutic options to offer patients for the treatment of episodic cluster headache. With today's approval, physicians are now armed with an FDA-approved medication that has the potential to help patients living with this condition by reducing the frequency of cluster attacks.” For episodic cluster headache, the recommended dosage of Emgality is 300 mg (administered as three consecutive subcutaneous injections of 100 mg each) at the onset of the cluster period, and then monthly until the end of the cluster period. Emgality will be available to patients for pickup at retail pharmacies. The U.S. list price of Emgality for the treatment of episodic cluster headache is the same per milligram as the migraine indication.     ]]> <![CDATA[Dr. Reddy's announces the re-launch of Zenatane]]> https://biospectrumindia.com/news/95/13803/dr-reddys-announces-the-re-launch-of-zenatane.html https://biospectrumindia.com/news/95/13803/dr-reddys-announces-the-re-launch-of-zenatane.html Thu, 06 Jun 2019 09:00:00 +0530 Dr. Reddy’s Laboratories has announced the relaunch of Zenatane® (Isotretinoin Capsules, USP), 10 mg, 20 mg, 30 mg and 40 mg a therapeutic equivalent generic version of Accutane®, approved by the U.S. Food and Drug Administration (USFDA). The product is being launched with an approved Risk Evaluation and Mitigation Strategy (REMS) Program. Marc Kikuchi, Chief Executive Officer, North America Generics said, “We’re pleased to bring this important product back to market for the customers and patients who will benefit from access to this medicine and who have had witnessed limited supply and options in the market place. Furthermore, this is important for our company as we have commercialized the first Softgel dosage product from Dr. Reddy’s own manufacturing plant to ensure consistent and robust supply for this product in the U.S. market.” The Zenatane (Isotretinoin Capsules, USP), 10 mg, 20 mg, 30 mg and 40 mg brand and generic had U.S. sales of approximately $525 million MAT for the most recent twelve months ending in March 2019 according to IQVIA Health. Dr. Reddy’s Zenatane (Isotretinoin Capsules, USP) are available in 3x10 (30-count) blister packages of 10 mg, 20 mg, 30 mg, and 40 mg Capsules, USP. ]]> <![CDATA[NATCO settles generic Carfilzomib Injection patent litigation in US ]]> https://biospectrumindia.com/news/95/13815/natco-settles-generic-carfilzomib-injection-patent-litigation-in-us-.html https://biospectrumindia.com/news/95/13815/natco-settles-generic-carfilzomib-injection-patent-litigation-in-us-.html Wed, 05 Jun 2019 15:05:00 +0530 NATCO Pharma Limited is pleased to announce that it has reached a Settlement Agreement with Onyx Therapeutics, Inc. on patent litigation related to generic versions of 10mg, 30mg and 60mg of Kyprolis®. NATCO has partnered with Breckenridge Pharmaceutical, Inc., who will market the product in the United States. The parties have reached a Settlement Agreement and the District Court case has been dismissed. By virtue of the settlement, NATCO and Breckenridge have been granted a license permitting the launch of their generic carfilzomib product on a date that is held as confidential in 2027 or sooner depending on certain occurrences. The parties cannot make further comment as to the terms of the Settlement Agreement. NATCO believes that its 10mg ANDA is sole first to file and could be eligible for 180-days marketing exclusivity for the 10mg strength under certain circumstances. Kyprolis® reportedly had sales of USD 586 million for the year ending December 2018 in the United States. ]]> <![CDATA[Japan’s PMDA completes inspection of Lupin’s Mandideep facility (Unit-2)]]> https://biospectrumindia.com/news/95/13811/japans-pmda-completes-inspection-of-lupins-mandideep-facility-unit-2.html https://biospectrumindia.com/news/95/13811/japans-pmda-completes-inspection-of-lupins-mandideep-facility-unit-2.html Wed, 05 Jun 2019 12:25:00 +0530 Pharma major Lupin has announced the completion of the Good Manufacturing Practices (GMP) inspection of its Mandideep facility (Unit-2), by the Pharmaceutical and Medical Devices Agency (PMDA), Japan. The inspection was conducted between May 14, 2019 and May 17, 2019. The PMDA inspection closed with no critical or major observations. Lupin is the 8th largest generics pharmaceutical company by revenues. The Company is the 3rd largest pharmaceutical player in the US by prescriptions (IQVIA MAT Mar 2019); 3rd largest Indian pharmaceutical company by global revenues; 5th largest company in the Indian Pharmaceutical Market and 6th largest generic pharmaceutical player in Japan (IQVIA MAT Mar 2019). For the financial year ended 31st March 2019, Lupin’s Consolidated sales and Net profits before exceptional items were at INR 163,694 million (USD 2.34 billion) and INR 9,466 million (USD 136 million) respectively. ]]> <![CDATA[Bio-Techne to acquire B-MoGen Biotechnologies Inc.]]> https://biospectrumindia.com/news/95/13810/bio-techne-to-acquire-b-mogen-biotechnologies-inc-.html https://biospectrumindia.com/news/95/13810/bio-techne-to-acquire-b-mogen-biotechnologies-inc-.html Wed, 05 Jun 2019 11:40:00 +0530 Bio-Techne Corporation announced it has reached agreement to acquire all of the stock of B-MoGen Biotechnologies Inc. The transaction has been completed and is being financed through available cash on hand. "We are very pleased to include the B-MoGen technology in Bio-Techne's expanding portfolio of products that serve the rapidly growing cell and gene therapy markets," commented Charles R. Kummeth, President and Chief Executive Officer of Bio-Techne.  "B-MoGen's technologies solve the most complex gene editing problems with proprietary, cutting edge gene editing and delivery tools, enabling and accelerating growth in immunotherapy treatments. This technology holds the promise of being able to deliver personalized therapeutic agents that have greater target effect and less off-target side effects. We are excited to continue to build our portfolio in cell and gene therapy workflow solutions, from cGMP grade antibodies and proteins for cell activation and expansion to the novel releasable, non-magnetic, Quickgel™ technologies. B-MoGen's key non-viral vector technology obviates several concerns associated with the use of viral vectors, including simplification of the entire vector manufacturing process, reduced biosafety concerns related to cytotoxicity, mutagenesis or malignant transformation of target cells and greater flexibility in payload size. The above assets represent key components of our burgeoning cell and gene therapy offering."     B-MoGen Biotechnologies' President and Chief Executive Officer Jeff Liter added, "Given our shared goal to move our products into clinical and commercial applications, there is a great strategic fit between the two companies. Our technology has delivered favorable results to those that have evaluated it and now with the resources and reagents Bio-Techne can provide, we will move more expeditiously to commercialize our technology. We are delighted with this transaction and we are pleased to have found a local home for our products and technology. The broad array of products, along with additional marketing and commercial resources, will serve our customers more efficiently and allow our products to be available on a global scale." B-MoGen Biotechnologies of Minneapolis was founded in 2015 as a startup out of the University of Minnesota and has approximately 20 employees. Co-founders include University of Minnesota researchers David Largaespada, Branden Moriarity and Beau Webber. ]]> <![CDATA[Lupin wins Packaging Award for its patient awareness initiative ‘Lupin Sahayak’]]> https://biospectrumindia.com/news/95/13804/lupin-wins-packaging-award-for-its-patient-awareness-initiative-lupin-sahayak.html https://biospectrumindia.com/news/95/13804/lupin-wins-packaging-award-for-its-patient-awareness-initiative-lupin-sahayak.html Tue, 04 Jun 2019 11:50:00 +0530 Lupin has announced that it has won the India Packaging Award 2019 for its patient awareness initiative ‘Lupin Sahayak’ and its special packaging for Telista. Telista is Lupin’s brand of Telmisartan and combinations that is used in the treatment of hypertension (high blood pressure), prevention of heart attack and stroke. Lupin Sahayak is a new initiative by Lupin’s Synox Team, that focuses on diabetes and hypertension. It offers a 24×7 WhatsApp helpline that will enable patients to get more information on hypertension. Speaking on the win Rajeev Sibal, President – India Region Formulations, Lupin Limited said, “Packaging is a key focus area for us and it is critical to get this right in keeping with the needs of customers. We at Lupin are delighted with this recognition on innovative packaging that enables patient awareness and meets the need of our valued customers.” The India Packaging Award 2019 given by UBM India was received for the category ‘Innovation in Patient Awareness Award’.   ]]> <![CDATA[PHARMEXCIL to host IPHEX 2019 in Gujarat]]> https://biospectrumindia.com/news/95/13795/pharmexcil-to-host-iphex-2019-in-gujarat.html https://biospectrumindia.com/news/95/13795/pharmexcil-to-host-iphex-2019-in-gujarat.html Tue, 04 Jun 2019 09:00:00 +0530 Bridging the gap between the global pharmaceutical procurement agencies and the small and medium scale sellers in the Indian market, the Pharmaceuticals Export Promotion Council of India (PHARMEXCIL), are set to host the 7th edition of their flagship event IPHEX 2019, at Helipad, Gandhinagar from June 10-12, 2019. This major initiative will welcome over 350 enterprises from all over India as well as more than 700 international buyers to interact on a single platform. Spread over the area of 30,000 sq.mt, this event will celebrate Gujarat’s active contribution in the industry. Previously, since its inception in 2013, it has been held in Mumbai, Delhi and Hyderabad.The exhibition aims to boost revenue brought in by the exports of drugs to 15% this year, as opposed to 11% growth with 19.13 billion in 2018. Speaking in an interaction with media, Mr. Vijay Shah, IPHEX-Chairman, said, “By creating an addition of 200 formulations to the already existing 800, we are looking to raise the bar of a percentage of exports from the current 30% in the global scenario. In its 7th edition, we may witness novel ideas being implemented, such as real-time online feedback system for both buyers and exhibitors, profiling of domestic visitors, color-coded panels for a tracked one-on-one interaction to act as a pre-information method. “ He also informed about the industry framework. “IPHEX is an integral part of PHARMEXCIL’s export market development strategy. IPHEX is helping Indian companies to establish a market in the United States, followed by Europe and Africa, but also explore the potential in China, Latin American countries and the CIS nation conglomeration as the new frontiers for Indian pharmaceutical exports.” IPHEX 2019 will also function as a mentoring event, with lounge area access for consultation and knowledge exchange, for those who want to enter this sector. Mr. Raghuveer Kini, Executive Director, PHARMEXCIL, mentioned that 7th IPHEX 2019 is a step forward by the Ministry of Commerce and Industry, Government of India, to encourage overseas buyers to recognize quality standards achieved by the sector and provide a much-needed push to consolidate India’s global leadership position in bulk and generic drug manufacturing. “With the states such as Gujarat, which has been one of the largest yet continuously evolving manufacturing laboratories, it will be great if we can showcase significant strides in the sector through this exhibition and simultaneously also help garner business for the industry ”, concluded Mr. Raghuveer Kini, Executive Director, PHARMEXCIL. ]]> <![CDATA[Cadila Pharma receives GLP certificate from government]]> https://biospectrumindia.com/news/95/13785/cadila-pharma-receives-glp-certificate-from-government.html https://biospectrumindia.com/news/95/13785/cadila-pharma-receives-glp-certificate-from-government.html Mon, 03 Jun 2019 12:45:00 +0530 Cadila Pharma recently received the Good Laboratory Practices Certification from National Good Laboratory Practice (GLP) compliance Monitoring Authority (NGCMA), Dept. of Science and Technology, Govt. of India, for their Pre-Clinical Department after an inspection was held from 4th to 6th February 2019. This certificate is for Dholka facility which is capable of conducting toxicity studies, mutagenicity studies, and analytical and clinical testing. Certificate  no. GLP/C-135/2019  was  issued on 6th May 2019. GLP is a data-driven system that establishes the use of industrial chemicals, pharmaceuticals, veterinary drugs, pesticides, cosmetic products, food products, feed additives products, etc. do not pose any hazards to human health and the environment. The inspection includes: Test Facility Inspection: An on-site examination of the test facility’s procedures and practices to assess the degree of compliance with GLP Principles. During inspections, the management structures and operational procedures of the test facility are examined, the key technical personnel is interviewed, and the quality and integrity of data generated by the facility are assessed and reported. Study Audit: A comparison of raw data and associated records with the interim or final report in order to determine whether the raw data have been accurately reported, to determine whether testing was carried out in accordance with the study plan and Standard Operating Procedures, to obtain additional information not provided in the report, and to establish whether practices were employed in the development of data that would impair their validity. Breaking the news Mr. Chintan Patel, Head Pre-Clinical & Innovation Team at Cadila Pharmaceuticals Ltd quoted “We are unique in a way where we can say we are ‘One stop solution’ and in pre-clinical research we do offer our pharma research experience and expertise for basic research as well as regulatory studies.” "With this milestone we are a GLP compliant facility, our regulatory research dossier will have an acceptance in all OECD member countries (>35).Also an additional support to offer services from NCE synthesis to clinical trials is added advantage for contracting R&D.” ]]> <![CDATA[Novartis gets FDA approval for gene therapy labeled at $2M]]> https://biospectrumindia.com/news/95/13774/novartis-gets-fda-approval-for-gene-therapy-labeled-at-2m.html https://biospectrumindia.com/news/95/13774/novartis-gets-fda-approval-for-gene-therapy-labeled-at-2m.html Fri, 31 May 2019 11:40:00 +0530 AveXis, a Novartis company, has announced the US Food and Drug Administration (FDA) has approved Zolgensma®(onasemnogene abeparvovec-xioi) for the treatment of pediatric patients less than 2 years of age with spinal muscular atrophy (SMA) with bi-allelic mutations in the survival motor neuron 1 (SMN1) gene. Zolgensma is designed to address the genetic root cause of SMA by providing a functional copy of the human SMN gene to halt disease progression through sustained SMN protein expression with a single, one-time intravenous (IV) infusion. Zolgensma is the first and only gene therapy approved by the FDA for the treatment of SMA, including those who are pre-symptomatic at diagnosis. This therapy comes with a price tag of $2.1 million, making it the most expensive drug. SMA is a rare, genetic neuromuscular disease caused by a defective or missing SMN1 gene. Without a functional SMN1 gene, infants with SMA lose the motor neurons responsible for muscle functions such as breathing, swallowing, speaking and walking. Zolgensma will be made available in the US and will be marketed by AveXis, a Novartis company. Outside of the US, Zolgensma has PRIME (PRIority MEdicines) designation in Europe and is being reviewed under Accelerated Assessment Procedure, and also has accelerated Sakigake designation in Japan. ]]> <![CDATA[AstraZeneca expands clinical research operations in India]]> https://biospectrumindia.com/news/95/13764/astrazeneca-expands-clinical-research-operations-in-india.html https://biospectrumindia.com/news/95/13764/astrazeneca-expands-clinical-research-operations-in-india.html Thu, 30 May 2019 15:30:00 +0530 Global science-led biopharmaceutical company, AstraZeneca officially announces the expansion of its clinical research operations in India with the launch of a new dedicated unit in Bengaluru. Inaugurated by Richard Homer, Deputy Head of Mission, British Deputy High Commission - Bengaluru, this new Development Operations centre will cement AstraZeneca’s position as a leading initiator of clinical research in the country. AstraZeneca is among the top 3 initiators of clinical studies among foreign pharmaceutical companies in India in the past three years, according to publicly available data. The new centre is located at Manyata business park alongside the India marketing and manufacturing headquarters.  The Development Operations centre will employ over 30 clinical research experts that handle over 20 studies in 150 sites across India.  This expansion will focus on managing studies in India to not only support the global clinical drug development, but also the local business with clinical data and evidence. The unit will support development of AstraZeneca’s medicines, hosting clinical trial experts focused on the company’s core therapeutic areas: oncology, cardiovascular, renal and metabolism, as well as respiratory. Dr. Melissa Grady, Senior Regional Director, Development Operations (Site Management and Monitoring), Asia, Middle East & Africa (AMEA) AstraZeneca present at the inauguration of the new clinical development center in Bengaluru said, “Over the last 40 years India has seen AstraZeneca’s commitment to enhance scientific innovation. Because of the excellent skills of Indian clinical research experts and the improvement of regulations and approval timelines, we are pleased to expand our operations and continue to lead clinical research in India. With the opening of this new office I am delighted to confirm the company’s continued commitment to the country. It is a next step towards supporting further expansion of both: the team and clinical trial activities in the country." With the improving regulations and approval timelines in India, AstraZeneca in India increased its local clinical trial activities during the last four years. As a result, the development operations team has grown from seven clinical trial experts in 2015 to 33 who are currently handling more than 20 clinical trials across 150 sites in India. Overall AstraZeneca in India, present through two legal entities, employs 4000 experts working across sales, marketing, manufacturing, Information Technology, research and development and clinical functions. “The new development operations site will see clinical trial experts working side by side to advance science in our core therapeutic areas - Oncology, Cardiovascular, Renal and Metabolism, and Respiratory. This will support and strengthen our focus on combining the expertise across our business to develop new ways to treat patients and tackle the significant unmet medical needs that exist in areas of non-communicable diseases,” said Mr. Gagandeep Singh Bedi, Managing Director, AstraZeneca Pharma India Limited. In line with the government’s “Make in India” initiative, AstraZeneca in India is committed to developing local skills, drive domestic scientific innovation and promote quality manufacturing with the aim to improve overall health outcomes in the country. In April 2018, AstraZeneca in India announced USD 90 million in new investment in India over five years, during Prime Minister Shri Narendra Modi’s state visit to Sweden. In India, AstraZeneca boasts of a strong presence with more than 4000 employees working across sales, marketing, manufacturing, Information Technology and development operations.  ]]> <![CDATA[Indian e-pharma market poised to touch US$2.7 billion by 2023: EY]]> https://biospectrumindia.com/news/95/13743/indian-e-pharma-market-poised-to-touch-us2-7-billion-by-2023-ey.html https://biospectrumindia.com/news/95/13743/indian-e-pharma-market-poised-to-touch-us2-7-billion-by-2023-ey.html Wed, 29 May 2019 15:10:00 +0530 According to a new EY report ‘e-pharma: delivering healthier outcomes’, e-pharma players are expected to attain a combined market size of US$2.7 billion by 2023 from about US$360 million currently in the next four years. The key growth drivers for e-pharma market are increase in internet penetration and smartphone ownership along with the ease of ordering medications through an e-commerce platform, increase in chronic diseases, rising per capita income and resultant healthcare spend. Ankur Pahwa, Partner and National Leader – E-Commerce and Consumer Internet, EY India, says, “Today, India is adapting to e-commerce rapidly with mobile-first consumer behavior and improving digital payments infrastructure, and online pharmacies, one of the verticals of e-commerce, are starting to gain momentum and have tremendous growth potential. The e-pharmacy market is expected to grow at a substantial pace in the next four years on the back of the renewed focus of the government and households on healthcare spending and the faster adoption of internet amongst users. It will not only create value for the customers but also generate a host of B2B opportunities going forward.” e-pharma presents a total addressable market size of US$9.3 billion as of 2019 and is estimated to grow at a CAGR of 18.1% to reach US$18.1billion by 2023. Interestingly, 35% of the domestic pharmaceutical market relates to chronic medications and the remaining 65% to acute medicines. Out of this, e-pharmacies are expected to target 85% of the chronic market and 40% of the acute medicine market (up from 25% in 2019) by 2023. This expected rise in the acute target market by e-pharmacies, can be attributed to an improvement in last mile logistics through collaboration with local pharmacies and integrating into existing hyperlocal models. Based on EY analysis, some of the other key findings from the report are: Cash burn in the e-pharma industry is common, because the discounts (up to 35% for some) exceed the margins in the chain (about 30-32%). While the race to scale, requires greater adoption and discounts are integral to that, but profitability cannot be achieved only by operational efficiency and lowering of delivery costs; discounts have to come down to reasonable levels to achieve breakeven and any meaningful profitability. e-pharmacies have other potential revenue generating opportunities that can further increase their overall market beyond the estimated US$2.7 billion by 2023. Providing diagnostics (collection of samples), ePrescription (where both doctors and patients will get the option to view past prescriptions, irrespective of their physical location) and health insurance services can enhance stickiness and engagement with customers, lower acquisition costs, help improve unit economics and widen the services portfolio. Despite increasing downloads of the mobile applications, certain challenges like trust deficit (arising from the fear of receiving counterfeit medicines), customer support issues (linked to timely delivery and quick redressal), language barrier (lack of mobile apps in regional languages), access (unable to reach remote parts of cities) and data privacy (especially with health records and prescriptions) remains in the online space. e-pharma companies are likely to rely on innovative digital marketing strategies to increase their customer base, user engagement and transactions/user. A major issue with the online pharmaceutical sector is compliance, i.e., the online players only dispense medicines after they verify the prescription. e-pharma companies are likely to be more compliant than their traditional counterparts, who refrain from keeping records of any sort. Use of technology in e-pharmacies to improve pharma supply chain: While a blockchain based system might enable e-pharma companies to efficiently manage their inventory levels to prepare for spikes in demand; similarly, an AI assistant can be employed for patient routing, symptom and medical record collection connected to doctor’s dashboard thereby providing accuracy of online consultations. Some of the key concerns faced by consumers while dealing with online pharmacies include order placement and delivery (cancellation after the order is placed or delay in the delivery), replacement with substitutes (i.e., same formulation, different brand as compared to what the doctor prescribed), order manipulation (delivering more quantities than needed), incorrect pricing (higher than MRP) and lack of customer support (i.e., delays and refusal to process refunds; absence of order tracking, among others). “In the near future, global e-commerce players will use their international experience and local omni-channel presence to make in-roads into the e-pharma segment. Fintech and healthtech players can look to expand offerings by getting into the segment. Hyperlocal players (food tech, grocery, delivery only companies) can also add on this segment to their existing portfolio to build efficiency on the delivery side. Even Indian players with deep omni-channel presence especially in emerging tier 2/3 towns with growing healthcare spends can add this vertical stream and can make a deep impact in the e-pharma sector,” adds Ankur Pahwa. e-pharma is emerging as an interesting space with large opportunities that are gaining interest from some of the key players in the e-commerce, consumer tech, fintech and hyperlocal space and from investors, both in India and globally. The below table lists the some of the key PE/VC deals in the e-pharma sector in the last two years. EY is a global leader in assurance, tax, transaction and advisory services. The insights and quality services we deliver help build trust and confidence in the capital markets and in economies the world over. We develop outstanding leaders who team to deliver on our promises to all of our stakeholders. In so doing, we play a critical role in building a better working world for our people, for our clients and for our communities.   ]]> <![CDATA[Glenmark receives ANDA approval for Aspirin and generic version of Aggrenox® Capsules ]]> https://biospectrumindia.com/news/95/13721/glenmark-receives-anda-approval-for-aspirin-and-generic-version-of-aggrenox-capsules-.html https://biospectrumindia.com/news/95/13721/glenmark-receives-anda-approval-for-aspirin-and-generic-version-of-aggrenox-capsules-.html Mon, 27 May 2019 12:40:00 +0530 Glenmark Pharmaceuticals has been granted final approval by the United States Food & Drug Administration (U.S. FDA) for Aspirin and Extended-Release Dipyridamole Capsules, 25 mg/200 mg, a generic version of Aggrenox® Capsules, 25 mg/200 mg, of Boehringer Ingelheim Pharmaceuticals, Inc. According to IQVIATM sales data for the 12 month period ending March 2019, the Aggrenox® Capsules, 25 mg/200 mg market2 achieved annual sales of approximately $165.6 million. Glenmark’s current portfolio consists of 155 products authorized for distribution in the U.S. marketplace and 57 ANDA’s pending approval with the U.S. FDA. ]]> <![CDATA[Zydus gets final approval from the USFDA for acid reflux drug]]> https://biospectrumindia.com/news/95/13716/zydus-gets-final-approval-from-the-usfda-for-acid-reflux-drug.html https://biospectrumindia.com/news/95/13716/zydus-gets-final-approval-from-the-usfda-for-acid-reflux-drug.html Fri, 24 May 2019 16:35:00 +0530 Zydus Cadila has received the final approval from the USFDA to market Esomeprazole Magnesium Delayed-Release Capsules USP (US RLD – NEXIUM), 25 mg and 40 mg. It will be manufactured at the group’s formulations manufacturing facility at SEZ, Ahmedabad. Esomeprazole belongs to the group of medicines termed as proton pump inhibitors. Esomeprazole reduces the amount of acid secreted by the stomach. It is used to treat the symptoms of gastroesophageal reflux disease, to reduce the risk of stomach ulcers in some people taking pain medicines, to treat patients with stomach infection (Helicobacter pylori) along with certain antibiotics and long-term treatment of conditions where stomach makes too much acid. The group now has 266 approvals and has so far filed over 350 ANDAs since the commencement of the filing process in FY2003-04. ]]> <![CDATA[Lupin launches Budesonide Inhalation Suspension]]> https://biospectrumindia.com/news/95/13709/lupin-launches-budesonide-inhalation-suspension.html https://biospectrumindia.com/news/95/13709/lupin-launches-budesonide-inhalation-suspension.html Fri, 24 May 2019 11:55:00 +0530 Lupin has announced the launch of its Budesonide Inhalation Suspension, 0.5 mg/2 mL Single-Dose Ampules in the US market, having received an approval from the United States Food and Drug Administration (FDA) earlier. Lupin’s Budesonide Inhalation Suspension, 0.5 mg/2 mL Single-Dose Ampules is a generic version of AstraZeneca Pharmaceuticals LP’s Pulmicort Respules Inhalation Suspension, 0.5 mg/2 mL. It is indicated for the maintenance treatment of asthma and as prophylactic therapy in children from 12 months to 8 years of age. Budesonide Inhalation Suspension, 0.5 mg/2 mL Single-Dose Ampules had annual sales of approximately USD 385.4 million in the US (IMS MAT March 2019).   ]]> <![CDATA[Health Canada approves Biocon and Mylan’s Ogivri]]> https://biospectrumindia.com/news/95/13701/health-canada-approves-biocon-and-mylans-ogivri.html https://biospectrumindia.com/news/95/13701/health-canada-approves-biocon-and-mylans-ogivri.html Thu, 23 May 2019 10:20:00 +0530 Biocon Ltd. and Mylan N.V. have announced that Health Canada has approved Mylan’s Ogivri™ (trastuzumab), a biosimilar to Herceptin® (trastuzumab) co-developed with Biocon, for the treatment of HER2-overexpressing breast cancer and metastatic stomach cancer (gastric or gastroesophageal junction adenocarcinoma). Ogivri is the first trastuzumab biosimilar approved in Canada and the second biosimilar from Biocon and Mylan’s joint portfolio approved in the market. Mylan plans to launch the product this quarter and anticipates potentially being the first company to offer a trastuzumab biosimilar in Canada. Dr Christiane Hamacher, CEO, Biocon Biologics said, “We are pleased to enable access to Ogivri, a high quality biosimilar trastuzumab co-developed and manufactured by Biocon as an affordable treatment option for HER2- positive breast and gastric cancer patients in Canada. The Health Canada approval granted to Ogivri, will pave the way for its commercialization by our partner Mylan. Thousands of patients in Europe, India and key emerging markets are benefitting from our biosimilar trastuzumab. Biocon Biologics is committed to address unmet patient needs through its high quality, affordable biologics, globally.” Mylan’s Chief Commercial Officer Tony Mauro commented, “As a global leader in the development of complex products, including biosimilar medicines, we’re pleased to reach this approval milestone for Ogivri and the opportunity to bring this important treatment option to market for Canadian patients with HER2-positive breast and gastric cancers. We look forward to continuing our reimbursement discussions with the Canadian Agency for Drugs and Technologies in Health (CADTH) and the Pan-Canadian Pharmaceutical Alliance (pCPA) to ensure that patients have access to Ogivri.” Approval by Health Canada was based on robust data from structural and functional characterization using multiple orthogonal techniques, nonclinical studies and pharmacokinetic evaluation in healthy subjects and patients and a safety, efficacy and immunogenicity study in relevant patient populations, which compared Ogivri to Herceptin. The data demonstrated that Ogivri is highly similar to Herceptin with no clinically meaningful differences in terms of efficacy, safety, purity and potency. Biocon and Mylan’s trastuzumab biosimilar is currently approved in more than 65 countries around the world, including the U.S.  ]]> <![CDATA[8th Annual InnoPack Pharma Confex engages industry audience]]> https://biospectrumindia.com/news/95/13699/8th-annual-innopack-pharma-confex-engages-industry-audience.html https://biospectrumindia.com/news/95/13699/8th-annual-innopack-pharma-confex-engages-industry-audience.html Thu, 23 May 2019 09:00:00 +0530 CPhI Conferences, a division of UBM India, which hosts a number of successful pharmaceutical conferences announced the 8th Annual InnoPack Pharma Confex slated for 21 - 22 May, 2019 at The Sahara Star, Mumbai. The Confex promised to be the biggest platform for professionals from the Pharma packaging industry to congregate, network, exchange ideas and knowledge, form alliances and shape the future of the pharma packaging industry, all under one roof.  The Indian pharmaceutical industry is undergoing fast-paced changes. According to the recent report from ResearchAndMarkets, the Indian generics market is witnessing rapid growth opening up immense opportunities for firms. This is further triggered by the fact that generics worth over $40 billion are going off patent in the coming few years which is close to 15% of the total prescription market of the US. The Indian Pharmaceutical Industry is growing at 11% annually and is ranked fourth globally in terms of volume, and thirteenth in terms of value. The Global Pharmaceutical Packaging Equipment market accounted for $5.98 billion in 2017 and is expected to reach $12.25 billion by 2026 growing at a CAGR of 8.3%. The pharmaceutical packaging market is increasingly playing a vital role in ensuring overall patient safety by carrying key information pertaining to product manufacturing, ensuring traceability of products and the industry is thriving with modernization due to several drivers. There is a growing regulatory thrust in this direction with complete unit level track and trace, innovations, patient safety and consumer preference becoming an everyday reality. The Confex ensured the continuous engagement of the audience, speakers and exhibitors through various networking activities and discussing the ever-evolving challenges and solutions in pharmaceutical packaging like ensuring patient safety through packaging, technological innovations, insights on successful and compliant implementation for pharmaceutical packaging. Last year, the 7th edition attracted above 700 delegates from across the country, over two action-packed days. This year, Ravi Udaya Bhaskar - Director General at Pharmaceuticals Export Promotion Council of India (PHARMEXCIL) inaugurated the Confex and shared his views on the evolution of the Indian pharma industry. The sessions over the two-day conference will be delivered by Richard HUA, International Affairs - Director, China Pharmaceutical Packaging Association; Crystal Edwards, Packaging Development Manager, Aspen Pharmacar e; Milagro Lopez - Director, Segment Marketing, Generics, West Pharma Inc; Bill Welch, Chief Technology Officer, Phillips-Medisize; Shaunak J. Dave, CEO (ASIA), Optel Group; Chakravarthi AVPS, Global Ambassador, World Packaging Organisation; Ashok Kumar Bhattacharya, Executive Director at Takeda Pharmaceuticals India Pvt. Ltd, and many more. InnoPack Pharma has already established itself as a premiere platform for Pharma packaging innovations. The conference will be followed by the fourth edition of The India Packaging Awards (21st May). The awards will recognize excellence and innovation in the packaging industry and celebrate the thinkers and creators who break new grounds in packaging. The evening witnessed the industry champions coming under a unique umbrella to cheer the inspiring masterminds and will comprise presentations, exclusive product launches, entertainment acts, along with the awards and recognition ceremony. Speaking on the announcement of the 8th Pharma InnoPack Conference, Mr Yogesh Mudras, Managing Director, UBM India, said, "According to industry reports, the Indian pharmaceutical packaging market, valued at an estimated Rs 147.8 billion in 2017, is now all set to reach a valuation of Rs 245.5 billion by the end of 2023. Besides, the focus on recycling and sustainability is also gaining popularity as is digitalization of packaging through smart methods. These aspects are no doubt transforming the pharmaceutical packaging industry and improving consumer interaction." "The 2 day InnoPack Pharma Confex is thus as timely as it is relevant. After all, to sustain serious growth, it is imperative for pharma packaging companies to focus on upscaled, quality-driven and creative solutions in terms of packaging. While appealing to the consumer, it needs to factor in the latest technology and sustainability so that the product is used under the best circumstances of temperature and usability. InnoPack has a legacy of showcasing the best of pharma packaging solutions in terms of quality and design. It is also set to witness scintillating panel discussions by leading experts, with a pulse on the key trends and issues in the sector, while updating it in the latest innovations across the globe," he added.   ]]> <![CDATA[Glenmark receives ANDA approval for generic version of Vesicare® Tablets ]]> https://biospectrumindia.com/news/95/13686/glenmark-receives-anda-approval-for-generic-version-of-vesicare-tablets-.html https://biospectrumindia.com/news/95/13686/glenmark-receives-anda-approval-for-generic-version-of-vesicare-tablets-.html Tue, 21 May 2019 14:50:00 +0530 Glenmark Pharmaceuticals has been granted final approval by the USFDA for Solifenacin Succinate Tablets, 5 mg and 10 mg, a generic version of Vesicare® Tablets, 5 mg and 10 mg, of Astellas Pharma US, Inc. According to IQVIATM sales data for the 12 month period ending March 2019, the Vesicare® Tablets, 5 mg and 10 mg market achieved annual sales of approximately $942.7 million. Glenmark’s current portfolio consists of 154 products authorized for distribution in the U.S. marketplace and 58 ANDA’s pending approval with the U.S. FDA. ]]> <![CDATA[Nestlé enters into exclusive negotiations to sell Nestlé Skin Health]]> https://biospectrumindia.com/news/95/13666/nestl-enters-into-exclusive-negotiations-to-sell-nestl-skin-health.html https://biospectrumindia.com/news/95/13666/nestl-enters-into-exclusive-negotiations-to-sell-nestl-skin-health.html Fri, 17 May 2019 14:50:00 +0530 Nestlé announced that it has entered into exclusive negotiations with a consortium led by EQT and a wholly owned subsidiary of the Abu Dhabi Investment Authority (ADIA) for the sale of Nestlé Skin Health for a value of CHF 10.2 billion. Nestlé Skin Health had net sales of CHF 2.8 billion in 2018. The proposed transaction will be subject to employee consultations and approval of regulatory authorities and is expected to close in the second half of 2019. The company will provide an update on the use of proceeds and its future capital structure at that time. Nestlé Skin Health provides science-based solutions to meet the specific skin health needs of healthcare professionals, patients and consumers. It offers a range of leading medical and consumer brands through three complementary business units in prescription, aesthetics and consumer care. Headquartered in Lausanne, Switzerland, Nestlé Skin Health employs more than 5,000 people across 40 countries. ]]> <![CDATA[Thermo Fisher to acquire GSK API Site for €90 M]]> https://biospectrumindia.com/news/95/13665/thermo-fisher-to-acquire-gsk-api-site-for-90-m.html https://biospectrumindia.com/news/95/13665/thermo-fisher-to-acquire-gsk-api-site-for-90-m.html Fri, 17 May 2019 12:30:00 +0530 Thermo Fisher Scientific Inc. the world leader in serving science, has entered into a definitive agreement to acquire a drug substance manufacturing site in Cork, Ireland, from GlaxoSmithKline plc (GSK) for approximately €90 million in cash. The Cork site will expand capacity to meet customer demand for the development and commercial manufacturing of complex active pharmaceutical ingredients (APIs). With more than 400 employees, the site produces highly specialized APIs for treating diseases including childhood cancer, depression and Parkinson's. Thermo Fisher will continue to produce APIs for GSK under a multi-year supply agreement and plans to expand use of the site to develop and produce complex APIs for other customers as well. The site contains 270 cubic meters of reactor capacity, 10 production buildings, an R&D pilot plant and lab infrastructure to support process development, scale-up and physical characterization of APIs. "The GSK Cork site will enhance our API offering by expanding our development and commercial capabilities to provide much-needed capacity for APIs currently in development," said Michel Lagarde, senior vice president and president of Pharma Services for Thermo Fisher Scientific. "This transaction is another great example of our strategy to build on our strong foundation by adding capacity and capabilities to our pharma services offering through a combination of capital investments and M&A." This announcement follows the recently completed acquisition of Brammer Bio, a leader in viral vector manufacturing for gene and cell therapies. Thermo Fisher is also investing $150 million to expand its sterile fill-finish sites in Monza and Ferentino, Italy, and Greenville, North Carolina, and plans to complete the previously announced $50 million expansion of its St. Louis, Missouri, biologics facility later this year. The GSK transaction, which is expected to be completed by the end of 2019, is subject to customary closing conditions, including regulatory approvals. Upon completion, the site will become part of Thermo Fisher's Pharma Services business within its Laboratory Products and Services Segment. ]]> <![CDATA[Roche gets FDA approval for Venclexta plus Gazyva]]> https://biospectrumindia.com/news/95/13656/roche-gets-fda-approval-for-venclexta-plus-gazyva.html https://biospectrumindia.com/news/95/13656/roche-gets-fda-approval-for-venclexta-plus-gazyva.html Thu, 16 May 2019 14:45:00 +0530 Roche announced that the US Food and Drug Administration (FDA) has approved Venclexta® (venetoclax) in combination with Gazyva®(obinutuzumab) for the treatment of people with previously untreated chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL). “Venclexta plus Gazyva is the only chemotherapy-free option of fixed duration that provides durable responses to help people live longer without progression of their disease, compared to a standard-of-care,” said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. “Today’s approval represents our long-standing commitment to helping people with blood cancers throughout the course of their disease, and we are excited to provide this new option for untreated chronic lymphocytic leukaemia.” The approval is based on the results of the randomised phase III CLL14 study, which evaluated 12-month, fixed-duration treatment with Venclexta plus Gazyva compared to Gazyva plus chlorambucil. Results showed the combination of Venclexta plus Gazyva produced a durable and significant reduction in the risk of disease worsening or death. The FDA rapidly reviewed and approved the supplemental New Drug Application (sNDA) under the FDA’s Real-Time Oncology Review (RTOR) and Assessment Aid pilot programmes. This is the second regimen of Roche medicines approved under the RTOR pilot programme, which is exploring a more efficient review process to ensure safe and effective treatments are available to patients as early as possible. The sNDA was also granted Priority Review, a designation given to medicines that the FDA has determined to have the potential to provide significant improvements in the treatment, prevention or diagnosis of a disease. The FDA previously granted Breakthrough Therapy Designation for Venclexta in combination with Gazyva for the treatment of previously untreated CLL with co-existing medical conditions. Additional submissions of the CLL14 data to health authorities around the world are ongoing. Venclexta is being developed by AbbVie and Roche. It is jointly commercialised by AbbVie and Genentech, a member of the Roche group, in the US and commercialised by AbbVie outside of the US. ]]> <![CDATA[Dr. Reddy's launches Daptomycin for Injection ]]> https://biospectrumindia.com/news/95/13642/dr-reddys-launches-daptomycin-for-injection-.html https://biospectrumindia.com/news/95/13642/dr-reddys-launches-daptomycin-for-injection-.html Wed, 15 May 2019 14:50:00 +0530 Dr. Reddy’s Laboratories Ltd. announced the launch of Daptomycin for Injection, 500mg/vial single-dose vial, a therapeutic equivalent generic version of Cubicin® for Injection, approved by the U.S. Food and Drug Administration (USFDA).   The Cubicin® for Injection (daptomycin for injection) brand and generic had U.S. sales of approximately $640.8 million MAT for the most recent twelve months ending in March 2019 according to IQVIA Health.  Dr. Reddy’s Daptomycin for Injection is available in single-dose 15 ml vials containing 500 mg of daptomycin. ]]> <![CDATA[GVK Bio, LifeArc celebrate a decade of partnership]]> https://biospectrumindia.com/news/95/13639/gvk-bio-lifearc-celebrate-a-decade-of-partnership.html https://biospectrumindia.com/news/95/13639/gvk-bio-lifearc-celebrate-a-decade-of-partnership.html Wed, 15 May 2019 14:40:00 +0530 GVK BIO, a leading global Contract Research and Development Organisation (CRDO), and LifeArc, one of UK’s top medical research charities, are pleased to announce the 10th anniversary of a successful partnership. The collaboration between LifeArc and GVK BIO brings together two organizations with a singular vision: advancing novel research ideas into potential medicines that can make a significant difference to patients. LifeArc’s novel approach involves levering partnerships with academia and leading service organizations to advance discoveries into promising medicines.  Over the past decade, LifeArc scientific teams have focused their efforts on modulating novel targets with therapeutic potential in diseases where there is patient need, with the GVK BIO team assisting in synthesizing complex molecules rapidly and cost effectively to drive iterative improvement in efficacy and safety. Promising novel chemical entities discovered from this partnership have been either advanced by LifeArc into clinical development, or have been licensed out to leading global pharmaceutical companies, including a recently announced deal in neuroscience. As the partnership evolved from a tactical relationship into a preferred partnership, the GVK BIO team has augmented LifeArc’s internal biology efforts, by supporting biochemical assays, carrying out drug metabolism and pharmacokinetics profiling studies, and soon, will be developing cell-based assays and running protein expression and purification studies. “It has been our privilege to have collaborated with LifeArc and its world class team of scientists that have delivered medicines such as Keytruda®, Tysabri®, and Entyvio® among others”, said Manni Kantipudi, Director & Chief Executive Officer, GVK BIO. “The longevity of this partnership, and the transformative results of the collaboration, serve as a testament to the capabilities of the GVK BIO team and its commitment to work with customers to make a difference in human life. We look forward to continuing this successful relationship with LifeArc in the coming years.” Commenting on the partnership, Melanie Lee, Chief Executive Officer, LifeArc said: “At LifeArc, we’re committed to translating scientific innovation to benefit patients. Our partnership with GVK BIO is a strong example of how shared goals and collaboration can create real value.” ]]> <![CDATA[Lupin receives EIR for Pharmacovigilance inspection from the USFDA]]> https://biospectrumindia.com/news/95/13633/lupin-receives-eir-for-pharmacovigilance-inspection-from-the-usfda.html https://biospectrumindia.com/news/95/13633/lupin-receives-eir-for-pharmacovigilance-inspection-from-the-usfda.html Tue, 14 May 2019 16:15:00 +0530 Pharma major Lupin Limited (Lupin) announced that it has received the Establishment Inspection Report (EIR) from the United States Food and Drug Administration (U.S. FDA) for the Post-marketing Adverse Drug Experience (PADE) inspection, indicating successful closure of the inspection.  The inspection was conducted at Lupin’s global pharmacovigilance group DSRM (Drug Safety & Risk Management) based out of Mumbai between 14th January, 2019 and 18th January, 2019. The inspection included a comprehensive scrutiny of practices and procedures for reporting of adverse events of Lupin’s marketed products worldwide. The inspection closed with four observations. ]]> <![CDATA[Glenmark receives ANDA approval for generic version of Nexium®]]> https://biospectrumindia.com/news/95/13625/glenmark-receives-anda-approval-for-generic-version-of-nexium.html https://biospectrumindia.com/news/95/13625/glenmark-receives-anda-approval-for-generic-version-of-nexium.html Tue, 14 May 2019 11:20:00 +0530 Glenmark Pharmaceuticals has been granted final approval by the United States Food & Drug Administration (U.S. FDA) for Esomeprazole Magnesium Delayed-Release Capsules USP, 20 mg and 40 mg, a generic version of Nexium® Delayed-Release Capsules, 20 mg and 40 mg, of AstraZeneca Pharmaceuticals LP. According to IQVIATM sales data for the 12 month period ending March 2019, the Nexium® Delayed Release Capsules, 20 mg and 40 mg market2 achieved annual sales of approximately $395.1 million. Glenmark’s current portfolio consists of 153 products authorized for distribution in the U.S. marketplace and 58 ANDA’s pending approval with the U.S. FDA. ]]> <![CDATA[Zydus receives USFDA nod for hypertension drug]]> https://biospectrumindia.com/news/95/13618/zydus-receives-usfda-nod-for-hypertension-drug.html https://biospectrumindia.com/news/95/13618/zydus-receives-usfda-nod-for-hypertension-drug.html Mon, 13 May 2019 15:50:00 +0530 Zydus Cadila has received the final approval from the USFDA to market Chlorthalidone Tablets USP (US RLD – THALITONE®), 25 mg and 50 mg. Chlorthalidone is used to treat high blood pressure (hypertension). It is also used to treat fluid retention (edema) in people with congestive heart failure, cirrhosis of the liver or kidney disorders or edema caused by taking steroids or estrogen. It will be manufactured at the group’s formulations manufacturing facility at SEZ, Ahmedabad. The group now has 266 approvals and has so far filed over 350 ANDAs since the commencement of the filing process in FY 2003-04. ]]> <![CDATA[Drug Control Lab functional at Bengaluru airport]]> https://biospectrumindia.com/news/95/13613/drug-control-lab-functional-at-bengaluru-airport.html https://biospectrumindia.com/news/95/13613/drug-control-lab-functional-at-bengaluru-airport.html Mon, 13 May 2019 14:25:00 +0530 The Kempegowda International Airport, Bengaluru (BLR Airport) – operated by Bangalore International Airport Ltd. (BIAL) now has a fully functional Drug Control Lab. “We are the first Airport in South India to house a fully operational Drug Control Lab, which incidentally is only the second and the largest such facility in the Country. Testing of all export and import of pharmaceuticals that is required by customs, is therefore done at the Cargo Terminal itself. In addition, the Coolport has also been awarded the Group Distribution Practices Certification for WHO-mandated standards," said Satyaki Raghunath, Chief Strategy and Development Officer, Bangalore International Airport Limited. “Our Drug Control Lab is now fully operational and our clients need not go to a city laboratory for the testing required by customs. This has enabled shippers considerable savings in transportation cost and time. Historically, raw material used to be imported to Mumbai and then ferried by road to Bengaluru. We are witnessing a 100 percent growth in import volumes with cargo now being sent directly to Bengaluru as it saves importers a huge amount of transaction cost. ” Raghunath said. BIAL’s vision is to make BLR Airport a successful passenger and cargo hub with state-of-the-art infrastructure and technological advancements that deliver efficient airport operations. ]]> <![CDATA[Lupin launches Clobazam tablets]]> https://biospectrumindia.com/news/95/13601/lupin-launches-clobazam-tablets.html https://biospectrumindia.com/news/95/13601/lupin-launches-clobazam-tablets.html Fri, 10 May 2019 13:45:00 +0530 Pharma major Lupin Limited (Lupin) announced the launch of Clobazam Tablets, 10 mg and 20 mg, having received an approval from the United States Food and Drug Administration (FDA) earlier.  Lupin’s Clobazam Tablets, 10 mg and 20 mg is the generic version of Lundbeck Pharms, LLC’s Onfi® Tablets, 10 mg and 20 mg. It is indicated for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 2 years of age or older.  Clobazam Tablets, 10 mg and 20 mg, had an annual sale of approximately USD 479 million in the US (IQVIA MAT March 2019). ]]> <![CDATA[Lupin to market Osteoarthritis product by Aptissen in Canada]]> https://biospectrumindia.com/news/95/13592/lupin-to-market-osteoarthritis-product-by-aptissen-in-canada.html https://biospectrumindia.com/news/95/13592/lupin-to-market-osteoarthritis-product-by-aptissen-in-canada.html Fri, 10 May 2019 09:00:00 +0530 Lupin Limited (Lupin) and Aptissen S.A. (Aptissen) announced that they have entered into a definitive distribution agreement under which Aptissen has granted Lupin the exclusive rights to market, distribute and sell the current Aptissen products in Canada. This includes immediate rights to distribute Synolis VA for the treatment of Osteoarthritis. Based on Statistics Canada, Osteoarthritis affects more than 10% of Canadians aged 15 or older. Synolis VA (Visco-Antalgic) is the intra-articular injection product for osteoarthritis with a unique combination of Hyaluronic Acid and high concentration of Sorbitol. Synolis VA 40/80 is already approved by Health Canada and an additional strength is currently under review. Commenting on this development, Dr. Sofia Mumtaz, President of Lupin Pharma Canada stated, “We are pleased to partner with Aptissen for marketing and distribution of Synolis VA, a branded product in Canada. This partnership helps us expand our product portfolio in the Canadian market. We remain committed to bring superior medical products and leverage our distribution strength to allow easy access to specialty medicines in the market.” Aptissen S.A. is a Swiss company founded in 2013 as a spin-off of ANTEIS and is based in the Geneva area, Switzerland.  Aptissen revolutionized the market by launching Synolis VA, the first intra-articular injection which combines Hyaluronic Acid (HA) with antioxidant (Sorbitol). ]]> <![CDATA[Glenmark announces results from a Phase 3 Study of Ryaltris™ ]]> https://biospectrumindia.com/news/95/13585/glenmark-announces-results-from-a-phase-3-study-of-ryaltris-.html https://biospectrumindia.com/news/95/13585/glenmark-announces-results-from-a-phase-3-study-of-ryaltris-.html Thu, 09 May 2019 14:20:00 +0530 Glenmark Pharmaceuticals has announced positive results from a Phase 3 study of Ryaltris, an investigational fixed-dose combination nasal spray for the treatment of seasonal allergic rhinitis (SAR). The study in patients aged 6 to under 12 years met its primary endpoint in achieving clinically meaningful and statistically significant change from baseline in average morning and evening Reflective Total Nasal Symptom Score (rTNSS) compared to placebo. Ryaltris (olopatadine hydrochloride [665 mcg] and mometasone furoate [25 mcg]), also known as GSP 301 Nasal Spray, has been conditionally accepted by the FDA as the brand name. Mahboob Rahman, Chief Medical Officer at Glenmark Pharmaceuticals said, “It has become increasingly important to conduct studies specifically designed for pediatric patients, so that we may gain insights into potential differences in safety, efficacy and dosing compared to studies in adult and adolescent populations. We are pleased to report that the safety and effectiveness observed in this pediatric population is consistent with our overall Phase 3 development program in SAR patients 12 years of age and older. These robust data contribute to the extensive clinical background supporting the effectiveness and tolerability of Ryaltris.” Glenmark Pharmaceuticals has studied Ryaltris in seven clinical trials involving more than 4,000 adult and adolescent patients (12 years of age and older). If approved by the FDA, Ryaltris will be commercialized by Glenmark Therapeutics Inc. USA, a wholly-owned subsidiary of Glenmark Holding, SA, that is dedicated to launching a portfolio of branded products in the therapeutic areas of respiratory and dermatology in the US. According to the most recent CDC data, almost 20 million adults in the United Sates are affected by seasonal allergic rhinitis every year. It is the primary diagnosis in over 11 million doctor’s visits annually and is estimated to affect more than seven percent of adults aged 18 years and over in the United States. ]]> <![CDATA[Biocon retains economic interest in global commercialization of Hulio]]> https://biospectrumindia.com/news/95/13578/biocon-retains-economic-interest-in-global-commercialization-of-hulio.html https://biospectrumindia.com/news/95/13578/biocon-retains-economic-interest-in-global-commercialization-of-hulio.html Wed, 08 May 2019 16:20:00 +0530 Pharma major Biocon retains economic interest in global commercialisation of Hulio in-licensed by Mylan. “Following the successful approval and European launch of Hulio®, (biosimilar Adalimumab) in-licensed by our partner Mylan from Fujifilm Kyowa Kirin Biologics, the commercialization rights have been extended from Europe to Global Markets,”stated the spokesperson of Biocon. Biocon, under the terms of its global partnership with Mylan for monoclonal antibodies, retains its economic interest in this expanded in-licensing arrangement and will gain a share of profits from Global Markets. The company said that, “Biocon is committed to enable patient access to affordable biosimilars and this partnership accelerates that process.” ]]> <![CDATA[Lupin receives tentative U.S. FDA approval for Fosaprepitant for Injection]]> https://biospectrumindia.com/news/95/13571/lupin-receives-tentative-u-s-fda-approval-for-fosaprepitant-for-injection.html https://biospectrumindia.com/news/95/13571/lupin-receives-tentative-u-s-fda-approval-for-fosaprepitant-for-injection.html Wed, 08 May 2019 12:05:00 +0530 Pharma major Lupin has announced that it has received tentative approval for its Fosaprepitant for Injection, 150 mg Single-Dose Vial, from the United States Food and Drug Administration (FDA) to market a generic version of Emend for Injection, 150 mg Single-Dose Vial, of Merck Sharp & Dohme Corp. (Merck). Lupin’s Fosaprepitant for Injection, 150 mg Single-Dose Vial, is the generic version of Merck’s Emend for Injection, 150 mg Single-Dose Vial. It is indicated for adults in combination with other antiemetic agents, for the prevention of: acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin. delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC). Fosaprepitant for Injection, 150 mg Single-Dose Vial, had annual sales of approximately USD 312 million in the US (IQVIA MAT March 2019). Lupin is an innovation led transnational pharmaceutical company developing and delivering a wide range of branded & generic formulations, biotechnology products and APIs globally. The Company is a significant player in the Cardiovascular, Diabetology, Asthma, Pediatric, CNS, GI, Anti-Infective and NSAID space and holds global leadership position in the Anti-TB segment. Lupin is the 8th largest generics pharmaceutical company in terms of market capitalization (28th December 2018, Bloomberg) and the 8th largest generics pharmaceutical company in terms of revenues (30th September 2018, Bloomberg LTM) globally. The Company is the 3rd largest pharmaceutical player in the US by prescriptions for the Total Market (IQVIA MAT December 2018); 3rd largest Indian pharmaceutical company by global revenues (30th September 2018, Bloomberg LTM); 6th largest generic pharmaceutical player in Japan (IQVIA MAT December 2018) and 5th largest company in the Indian Pharmaceutical Market (IQVIA MAT December 2018). For the financial year ended 31st March, 2018, Lupin’s Consolidated sales and Net profits before exceptional items were at Rs. 155,598 million (USD 2.41 billion) and Rs. 13,934 million (USD 216 million) respectively.  ]]> <![CDATA[Lupin receives tentative USFDA approval for Fosaprepitant for Injection]]> https://biospectrumindia.com/news/95/13570/lupin-receives-tentative-usfda-approval-for-fosaprepitant-for-injection.html https://biospectrumindia.com/news/95/13570/lupin-receives-tentative-usfda-approval-for-fosaprepitant-for-injection.html Wed, 08 May 2019 12:00:00 +0530 Lupin Limited (Lupin) has received tentative approval for its Fosaprepitant for Injection, 150 mg Single-Dose Vial, from the United States Food and Drug Administration (FDA) to market a generic version of Emend for Injection, 150 mg Single-Dose Vial, of Merck Sharp & Dohme Corp. (Merck). Lupin’s  Fosaprepitant for Injection, 150 mg Single-Dose Vial, is the generic version of Merck’s Emend for Injection, 150 mg Single-Dose Vial. It is indicated for adults in combination with other antiemetic agents, for the prevention of: acute and delayed nausea and vomiting associated with initial and repeat courses of highly emetogenic cancer chemotherapy (HEC) including high-dose cisplatin. delayed nausea and vomiting associated with initial and repeat courses of moderately emetogenic cancer chemotherapy (MEC). Fosaprepitant for Injection, 150 mg Single-Dose Vial, had annual sales of approximately USD 312 million in the US (IQVIA MAT March 2019). ]]> <![CDATA[Alembic gets USFDA nod for Olopatadine Hydrochloride Ophthalmic Solution]]> https://biospectrumindia.com/news/95/13569/alembic-gets-usfda-nod-for-olopatadine-hydrochloride-ophthalmic-solution.html https://biospectrumindia.com/news/95/13569/alembic-gets-usfda-nod-for-olopatadine-hydrochloride-ophthalmic-solution.html Wed, 08 May 2019 11:45:00 +0530 Alembic Pharmaceuticals Limited recently announced that the Company has received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Olopatadine Hydrochloride Ophthalmic Solution USP, 0.2%. The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Pataday Ophthalmic Solution, 0.2%, of Novartis Pharmaceuticals Corporation. Olopatadine Hydrochloride Ophthalmic Solution USP, 0.2% is indicated for the treatment of ocular itching associated with allergic conjunctivitis. Olopatadine Hydrochloride Ophthalmic Solution USP, 0.2% has an estimated market size of US$ 62 million for twelve months ending December 2018 according to IQVIA. Alembic now has a total of 93 ANDA approvals (81 final approvals and 12 tentative approvals) from USFDA. ]]> <![CDATA[Alembic forms JV to sell products in Chinese market]]> https://biospectrumindia.com/news/95/13567/alembic-forms-jv-to-sell-products-in-chinese-market.html https://biospectrumindia.com/news/95/13567/alembic-forms-jv-to-sell-products-in-chinese-market.html Wed, 08 May 2019 11:10:00 +0530 Alembic has entered into a Joint Venture Agreement (JVA) dated 7th May, 2019 with SPH SINE Pharmaceutical Laboratories Co Ltd, China ('SPH Sine') & Adia (Shanghai) Pharma Co Ltd, China ('Adia') to promote and sell pharmaceutical products for the Chinese market. Initially this JV will commercialize products manufactured by Alembic Pharmaceuticals Limited. Subsequently the JV plans to set up a manufacturing facility in China. The JV will commercialize products in the Chinese market which has an increasing demand for generic drugs. It will initially launch with a portfolio of oral solids and is expected to widen to other areas like injectable, ophthalmology, dermatology & oncology which arebeinq currently developed and manufactured by Alembic. SPH Sine, Alembic & Adia shall hold 51%, 44% & 5% equity in the JVA. The JVA has standard terms including management functioning, restriction on transfer of shares, non-compete and termination events and consequences. The signing of JVA was done at the Vadodara Headquarters of Alembic Pharmaceuticals Limited in august presence of: Mr. Zhao Yong, Chief Minister of SPH Group; Mr. Gu Haoliang, Chairman of SPH Sine; Mr. Chirayu Amin, Chairman & CEO of Alembic; Mr. Pranav Amin, Managing Director of Alembic; Mrs. Hua Wei, President of Adia; and other senior level dignitaries from all the organizations. ]]> <![CDATA[Merck Limited changes name to Procter & Gamble Health Limited]]> https://biospectrumindia.com/news/95/13557/merck-limited-changes-name-to-procter-gamble-health-limited.html https://biospectrumindia.com/news/95/13557/merck-limited-changes-name-to-procter-gamble-health-limited.html Tue, 07 May 2019 11:45:00 +0530 Following P&G’s global acquisition of the consumer health business of Merck KGaA, Darmstadt, the Company has received approval from the Registrar of Companies, Mumbai, Maharashtra for change of name from Merck Limited to Procter & Gamble Health Limited effective May 6, 2019. Commenting on the name change, Milind Thatte, Managing Director, Procter & Gamble Health Limited said, “Today marks the beginning of an exciting new era for Procter & Gamble Health Limited (formerly Merck Limited), one of India’s largest Consumer Health companies. Our new name reflects our new identity as part of the P&G Group and signifies the coming together of strong consumer health capabilities and cultures. Together, we are working towards leveraging our combined expertise to develop categories and brands that meet today’s needs and tomorrow’s opportunities.” The decision to change the name of the listed entity in India follows the successful completion of P&G’s global acquisition of the consumer health business of Merck KGaA, Darmstadt, Germany. The consumer health business was transferred to P&G on December 1, 2018. Tom Finn, President, Global Personal Health Care, Procter & Gamble shared “I am delighted to announce the new name of our listed entity which will now be known as Procter & Gamble Health Limited. With India’s OTC market growing at double the global growth rate, this is a very exciting phase for all of us as we now move forward to realize the great potential of our two health-related P&G businesses in India.” Procter & Gamble Health Limited will be a part of P&G’s Personal Health Care International Business Unit led by Uta Kemmerich-Keil (Vice President, Personal Health Care International) which encompasses our health care businesses in Europe, Latin America, and Asia/IMEA (India, Middle East and Africa). “We are extremely pleased with this development. With our strong portfolio of brands that are backed by science and trusted by doctors, pharmacists and consumers, we believe that we are wellpositioned to enable consumers in India to live longer, healthier and more vibrant lives,” said Uta Kemmerich-Keil, Vice President, Personal Health Care International, Procter & Gamble. ]]> <![CDATA[USFDA classifies Strides Puducherry facility as Official Action Initiated (OAI)]]> https://biospectrumindia.com/news/95/13544/usfda-classifies-strides-puducherry-facility-as-official-action-initiated-oai.html https://biospectrumindia.com/news/95/13544/usfda-classifies-strides-puducherry-facility-as-official-action-initiated-oai.html Mon, 06 May 2019 14:05:00 +0530 Strides Pharma Science ltd. has received a communication from the US Food and Drug Administration (USFDA) on May 4, 2019, classifying the facility as OAI based on the inspection conducted from January 28 to February 5, 2019.  According to the USFDA, an OAI means regulatory and/or administrative actions will be recommended for the facility which was inspected after it determines if the areas evaluated were in compliance with applicable laws and regulations.  "While the company is disappointed with the outcome of the inspection, the company believes that the classification will not have an impact on the current supplies and revenues from the facility," Strides Pharma Sciences said in statement.  However, of the 34 ANDA’s pending approval, Puducherry has 10 ANDA’s where the Company expects delays until the facility is reclassified. ]]> <![CDATA[Dr Reddy's launches testosterone gel in US market]]> https://biospectrumindia.com/news/95/13541/dr-reddys-launches-testosterone-gel-in-us-market.html https://biospectrumindia.com/news/95/13541/dr-reddys-launches-testosterone-gel-in-us-market.html Mon, 06 May 2019 11:15:00 +0530 Dr. Reddy’s Laboratories Ltd., along with its subsidiaries together referred to as “Dr. Reddy’s” has announced the launch of Testosterone Gel 1.62%, a therapeutic equivalent generic version of AndroGel® (testosterone gel) 1.62%, approved by the U.S. Food and Drug Administration (USFDA).  The AndroGel® (testosterone gel) brand and generic had U.S. sales of approximately $815.6 million MAT for the most recent twelve months ending in February 2019 according to IQVIA Health. Dr. Reddy’s Testosterone Gel 1.62% (20.25 mg/1.25 g pump actuation) is available in a net quantity of 88 g pump which dispenses 20.25 mg of testosterone per actuation. Each metered-dose pump is capable of dispensing 60 metered pump actuations. ]]> <![CDATA[Dr. Reddy's announces the launch of Testosterone Gel ]]> https://biospectrumindia.com/news/95/13542/dr-reddys-announces-the-launch-of-testosterone-gel-.html https://biospectrumindia.com/news/95/13542/dr-reddys-announces-the-launch-of-testosterone-gel-.html Mon, 06 May 2019 11:15:00 +0530 Dr. Reddy’s Laboratories has announced the launch of Testosterone Gel 1.62%, a therapeutic equivalent generic version of AndroGel® (testosterone gel) 1.62%, approved by the U.S. Food and Drug Administration (USFDA).  The AndroGel® (testosterone gel) brand and generic had U.S. sales of approximately $815.6 million MAT for the most recent twelve months ending in February 2019 according to IQVIA Health. Dr. Reddy’s Testosterone Gel 1.62% (20.25 mg/1.25 g pump actuation) is available in a net quantity of 88 g pump which dispenses 20.25 mg of testosterone per actuation. Each metered-dose pump is capable of dispensing 60 metered pump actuations.   ]]> <![CDATA[Glenmark announces co-promotion agreement with Otonomy]]> https://biospectrumindia.com/news/95/13527/glenmark-announces-co-promotion-agreement-with-otonomy.html https://biospectrumindia.com/news/95/13527/glenmark-announces-co-promotion-agreement-with-otonomy.html Fri, 03 May 2019 10:00:00 +0530 Glenmark Therapeutics has announced a co-promotion agreement with Otonomy, a biopharmaceutical company dedicated to the development of innovative therapeutics for neurotology. Glenmark Therapeutics is dedicated to developing and commercializing a franchise of branded products for Glenmark Pharmaceuticals and is focused in the areas of respiratory and dermatology. Ryaltris™ (olopatadine hydrochloride [665 mcg] and mometasone furoate [25 mcg]), formerly GSP 301 Nasal Spray, is the company’s leading respiratory pipeline asset and currently under review with the U.S. Food and Drug Administration (FDA) as a treatment of seasonal allergic rhinitis in patients 12 years and older. “Ryaltris” has been conditionally accepted by the FDA as the brand name. This agreement provides Glenmark Therapeutics with an exclusive right to promote OTIPRIO (ciprofloxacin otic suspension) for the treatment of acute otitis externa (AOE) in patients 6 months of age and older due to Pseudomonas aeruginosa and Staphylococcus aureus in ear, nose and throat specialist offices in the United States and its territories. Robert Matsuk, President North America for Glenmark Therapeutics said, “We are pleased to collaborate with Otonomy on this agreement which represents an excellent opportunity to fit within our respiratory franchise and supports our strategy of maintaining commercial emphasis on specialists. With FDA review of our first New Drug Application for Ryaltris well underway, we remain focused on developing new partnerships that bolster our specialty portfolio and commercial footprint in the U.S. This agreement is a clear example of Glenmark Therapeutics’ efforts to maximize and grow our presence by pursuing opportunities both through external partnerships and our internal R&D pipeline.” Financial terms for the multi-year agreement were not disclosed; however, Glenmark Therapeutics will provide Otonomy an annual co-promotion fee and provide reimbursement of a proportion of product support expenses. In addition, Otonomy will retain a share of the adjusted gross profits from the sale of OTIPRIO to Glenmark's accounts. Commercial rights for use of OTIPRIO in other indications, including treatment of bilateral otitis media with effusion in patients 6 months and older who need ear tubes, will remain with Otonomy.   ]]> <![CDATA[SIFI, Zydus to launch innovative intraocular lenses in India]]> https://biospectrumindia.com/news/95/13508/sifi-zydus-to-launch-innovative-intraocular-lenses-in-india.html https://biospectrumindia.com/news/95/13508/sifi-zydus-to-launch-innovative-intraocular-lenses-in-india.html Wed, 01 May 2019 12:25:00 +0530 SIFI, the Italian leader in the development of therapeutic solutions to treat ophthalmic disorders and global pharmaceutical major, Zydus Cadila, have tied up to market innovative IOLs (Intraocular lenses) and surgical products developed in Italy and licensed in India by SIFI.SIFI's innovative IOLs (Intraocular lenses) have been approved by the Central Drugs Standards Control Organization (Directorate General of Health Services) and Ministry of Health & Family Welfare (Medical Device and Diagnostic Division). These surgical devices represent the most advanced solution for cataract refractive surgery and the correction of astigmatism (a type of refractive error where the cornea is irregularly shaped) and presbyopia (natural loss of the ability to focus on nearby objects that occurs with ageing).‘Refractive cataract’ is nowadays at the frontier of cataract surgery as it combines clouded lens removal to the simultaneous correction of refractive errors such as myopia, hypermetropia, astigmatism and presbyopia, in order to free the patient from wearing glasses following the surgery.The most advanced IOLs for this purpose are the EDOF (Extended Depth of Focus) lenses that present an optical plate with a continuous series of focuses to ensure a continuum correction from far to near in case of presbyopia and in case of astigmatism to provide compensation of the corneal abnormal curvature.SIFI and Zydus look forward to bringing such innovations to India and to the entire South Asia region in order to empower surgeons with an advanced technology and consequently better the quality of vision and life of patients. ]]> <![CDATA[AstraZeneca starts AI collaboration to accelerate drug discovery]]> https://biospectrumindia.com/news/95/13507/astrazeneca-starts-ai-collaboration-to-accelerate-drug-discovery.html https://biospectrumindia.com/news/95/13507/astrazeneca-starts-ai-collaboration-to-accelerate-drug-discovery.html Wed, 01 May 2019 11:50:00 +0530 AstraZeneca and BenevolentAI have begun a long-term collaboration to use artificial intelligence (AI) and machine learning for the discovery and development of new treatments for chronic kidney disease (CKD) and idiopathic pulmonary fibrosis (IPF). Scientists from the two organisations will work side-by-side to combine AstraZeneca’s genomics, chemistry and clinical data with BenevolentAI’s target identification platform and biomedical knowledge graph – a network of contextualised scientific data (genes, proteins, diseases and compounds) and the relationship between them. Machine learning systematically analyses data to find connections between facts, and AI-based reasoning is used to extrapolate previously unknown connections. Together, the companies will interpret the results to understand the underlying mechanisms of these complex diseases and more quickly identify new potential drug targets. Mene Pangalos, Executive Vice President and President BioPharmaceuticals R&D, said: “The vast amount of data available to research scientists is growing exponentially each year. By combining AstraZeneca’s disease area expertise and large, diverse datasets with BenevolentAI’s leading AI and machine learning capabilities, we can unlock the potential of this wealth of data to improve our understanding of complex disease biology and identify new targets that could treat debilitating diseases.”   Joanna Shields, Chief Executive Officer, BenevolentAI, said: “Millions of people today suffer from diseases that have no effective treatment. The future of drug discovery and development lies in bridging the gap between AI, data, and biology. We are thrilled to be joining forces with AstraZeneca to develop new insights and identify promising new treatments for chronic kidney disease and idiopathic pulmonary fibrosis.” CKD and IPF are complex diseases in which the underlying disease biology is poorly understood. This disease complexity requires the interrogation of vast, rich datasets. BenevolentAI is a global AI leader focused on drug discovery. The company has developed the Benevolent Platform, an AI discovery platform which can be used by scientists to try to discover novel pathways and mechanisms important in the pathophysiology of disease.    ]]> <![CDATA[Lupin in alliance with Natco receives FDA approval for Bosentan Tablets]]> https://biospectrumindia.com/news/95/13506/lupin-in-alliance-with-natco-receives-fda-approval-for-bosentan-tablets.html https://biospectrumindia.com/news/95/13506/lupin-in-alliance-with-natco-receives-fda-approval-for-bosentan-tablets.html Wed, 01 May 2019 11:45:00 +0530 Lupin in alliance with Natco Pharma (Natco) announced that it has received approval for Bosentan Tablets, 62.5 mg and 125 mg, from the United States Food and Drug Administration (FDA) to market a generic version of Actelion Pharmaceuticals Limited’s Tracleer Tablets, 62.5 mg and 125 mg. Lupin and Natco’s Bosentan Tablets, 62.5 mg and 125 mg, is the generic version of Actelion Pharmaceuticals Limited’s Tracleer Tablets, 62.5 mg and 125 mg. It is indicated for the treatment of pulmonary arterial hypertension in adults to improve exercise ability and to decrease clinical worsening. Bosentan Tablets, 62.5 mg and 125 mg had an annual sales of approximately USD 84.8 million in the US (IQVIA MAT March 2019).   ]]> <![CDATA[Glenmark launches novel anti-diabetes drug in India]]> https://biospectrumindia.com/news/95/13499/glenmark-launches-novel-anti-diabetes-drug-in-india.html https://biospectrumindia.com/news/95/13499/glenmark-launches-novel-anti-diabetes-drug-in-india.html Tue, 30 Apr 2019 11:35:00 +0530 Glenmark Pharmaceuticals Ltd. (Glenmark), a research-led global integrated pharmaceutical company, has announced the launch of its novel, patent protected and globally-researched sodium glucose co-transporter-2 (SGLT2) inhibitor Remogliflozin etabonate (Remogliflozin) in India. The drug is indicated in the treatment of type-2 diabetes mellitus in adults. SGLT2 inhibitors are novel anti-diabetic drugs that help achieve glycemic control by acting on the SGLT2 receptors in the proximal tubule of the kidney, thereby preventing renal reabsorption of glucose and promoting excretion of glucose in the urine. SGLT2 drugs provide glycemic control, induce weight loss and reduce cardiovascular risks. Glenmark is the first company in the world to launch the novel SGLT2 inhibitor Remogliflozin and India is the first country to get access to this innovative drug. Glenmark will commercialize Remogliflozin in India under the brand names “Remo” and “Remozen”. Glenmark received regulatory approval for Remogliflozin etabonate 100 mg tablets, twice daily, after successfully completing Phase-3 clinical trials in which Remogliflozin demonstrated good efficacy and safety profile in a head-to-head comparison against Dapagliflozin. Remogliflozin, the latest drug in SGLT2 inhibitors’ class to get regulatory approval in the world, has been studied in 26 clinical trials globally, covering around 2,500 patients from various ethnicities. Remogliflozin was discovered and developed by Japanese firm Kissei Pharmaceutical Co. Ltd. and later developed by GlaxoSmithKline plc and Glenmark collaborator BHV Pharma, a wholly owned subsidiary of Avolynt, Inc. which is based in North Carolina, USA. Glenmark secured certain rights to Remogliflozin through a licensing collaboration agreement with BHV Pharma, and conducted the Phase-3 clinical trial. “Globally, SGLT2 inhibitors are emerging as a preferred treatment for management of type-2 diabetes and Glenmark is proud to introduce a novel molecule in this class, which is cutting-edge and researched extensively. Diabetes is a key area of focus for Glenmark and with the launch of Remogliflozin, the company aims to improve access to SGLT2 inhibitors by providing an effective, high quality and world-class treatment option to patients in India,” said Sujesh Vasudevan, President, India Formulations, Middle East and Africa at Glenmark Pharmaceuticals. The American Diabetes Association and the European Association for the Study of Diabetes have recommended use of SGLT2 inhibitors as an alternative first line treatment to Metformin or as an adjunctive treatment in the management of type-2 diabetes mellitus. SGLT2 inhibitors are particularly recommended for use in patients that have certain established cardiovascular diseases. India is estimated to have around 72 million adults living with diabetes, according to the International Diabetes Federation’s Diabetes Atlas 2017.   ]]> <![CDATA[Cipla receives final approval for generic version of Letairis® ]]> https://biospectrumindia.com/news/95/13493/cipla-receives-final-approval-for-generic-version-of-letairis-.html https://biospectrumindia.com/news/95/13493/cipla-receives-final-approval-for-generic-version-of-letairis-.html Tue, 30 Apr 2019 09:50:00 +0530 Cipla has announced the receipt of final approval for the Abbreviated New Drug Application (ANDA) for Ambrisentan Tablets 5mg & 10mg from the United States Food and Drug Administration (US FDA).  Cipla’s Ambrisentan Tablets 5mg & 10mg is AB-rated generic therapeutic equivalent version of Gilead Sciences, Inc’s Letairis®. Ambrisentan tablet is an endothelin receptor antagonist indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise ability and delay clinical worsening.  The U.S. Sales of Letairis® Tablets USP stood at $943 million in 2018. The product is available for shipping immediately. ]]> <![CDATA[Regeneron, Sanofi’s Praluent set to reduce heart problems]]> https://biospectrumindia.com/news/95/13487/regeneron-sanofis-praluent-set-to-reduce-heart-problems.html https://biospectrumindia.com/news/95/13487/regeneron-sanofis-praluent-set-to-reduce-heart-problems.html Mon, 29 Apr 2019 15:00:00 +0530 Regeneron Pharmaceuticals, Inc. and Sanofi have announced that the U.S. Food and Drug Administration (FDA) has approved Praluent® (alirocumab) to reduce the risk of heart attack, stroke and unstable angina requiring hospitalization in adults with established cardiovascular (CV) disease. "Heart disease accounts for one quarter of all American deaths each year and many others are at risk for heart attack and stroke due to uncontrolled LDL-C levels," said George D. Yancopoulos, M.D., Ph.D., President and Chief Scientific Officer, Regeneron. "The Phase 3 ODYSSEY OUTCOMES trial showed that people who received Praluent significantly reduced their risk for serious cardiovascular events. There was also a clinically-meaningful reduction in death from any cause with Praluent treatment. With this approval, and the recent introduction of a lower U.S. Praluent list price, we hope that more patients in need will be able to access Praluent." High levels of "bad" cholesterol, also known as low-density lipoprotein cholesterol (LDL-C), increase patients' risk for serious CV events such as heart attack or stroke. Adults who experience a heart attack or stroke have an approximately one in three chance to have another CV event.  The FDA approval is based on data from ODYSSEY OUTCOMES. The FDA also approved Praluent as an adjunct to diet, alone or in combination with other lipid-lowering therapies (e.g., statins, ezetimibe), for the treatment of adults with primary hyperlipidemia (including heterozygous familial hypercholesterolemia) to reduce LDL-C. Praluent was the first PCSK9 (proprotein convertase subtilisin/kexin type 9) inhibitor approved by the FDA and is the only PCSK9 inhibitor available in two doses with two levels of efficacy as a single 1 mL injection (75 mg and 150 mg) once every two weeks. It can also be administered as 300 mg once every four weeks (monthly), enabling physicians to tailor treatment based on an individual patient's LDL-C-lowering needs. ]]> <![CDATA[ACG commits to further investment in Brazil]]> https://biospectrumindia.com/news/95/13485/acg-commits-to-further-investment-in-brazil.html https://biospectrumindia.com/news/95/13485/acg-commits-to-further-investment-in-brazil.html Mon, 29 Apr 2019 09:00:00 +0530 ACG Capsules headquartered in Mumbai, launches a new factory in Pouso Alegre-MG, generating local employment ACG Group, the only supplier in the world offering end-to-end manufacturing solutions for the pharmaceutical industry, has expanded its footprint in Brazil with the launch of its new capsules manufacturing plant in Pouso Alegre-Minas Gerais. With approximately R$(Brazilian Real) 350 million invested, this factory spans an area of 14,000 m² and will generate around 500 new jobs locally. Following the acquisition of Nova Nordeplast (Films and Foils company) in 2017, this is the second ACG manufacturing facility in the region. Both will serve the entire LATAM and neighboring areas. The new ACG capsule manufacturing facility complies with the highest standards defined by the Brazilian Health Regulatory Agency ANVISA & GMP regulatory bodies. Selwyn Noronha, CEO ACG Capsules, said, “ACG Capsules is one of the largest capsule manufacturers in the world, servicing pharmaceutical and nutraceutical customers in more than 100 countries. The company already has a significant presence in LATAM, and following this investment, ACG will further be able to meet the growing requirements of the region.” Both Nova Nordeplast and the new ACG Capsule plant will offer unique and differentiated solutions with faster response times to customers in the region. ACG Capsules has also pioneered printing on hard capsules that allows the pharmaceutical companies to create brand differentiation in the market and thwart the threat of counterfeit or falsified drugs. “ACG is extremely proud of this new state-of-the-art facility, which demonstrates our long-term commitment to Brazil. As the fifth largest pharmaceutical market in the world, Brazil is a key strategic one for ACG. And the benefit of having local manufacturing will certainly strengthen ties with our customers”, commented Roberson Petrungaro, Commercial Director – LATAM, ACG Capsules. ]]> <![CDATA[Biocon Q4FY19 Revenue Rs 1,557 Cr, Up 26%]]> https://biospectrumindia.com/news/95/13484/biocon-q4fy19-revenue-rs-1557-cr-up-26.html https://biospectrumindia.com/news/95/13484/biocon-q4fy19-revenue-rs-1557-cr-up-26.html Fri, 26 Apr 2019 16:50:00 +0530 Biocon Ltd, Asia's premier biopharmaceuticals company, today announced its consolidated financial results for the fourth quarter and fiscal year ended March 31st , 2019. Commenting on the highlights, Kiran Mazumdar-Shaw, Chairperson & Managing Director, stated: “Our Q4 FY19 performance was led by robust growth in our Biologics and Research Services business segments, supported by a significant growth in the Small Molecules business. “On an annual basis, our Revenue grew 31% to Rs 5,659 Crore, and Net Profit soared 143% to Rs 905 Crore. FY19 was a landmark year for the Biologics business, which reported a growth of 97%, thus emerging as a key driver for Biocon’s incremental growth. Our three strategic business segments Small Molecules, Biologics and Research Services have reported a top-line of over Rs 1,500 Crore each this fiscal. A higher share of Biologics revenue boosted profitability as reflected in the consolidated EBITDA margin of 27% for the full year despite a 34% increase in Net R&D expenses. “Looking ahead in FY20, we expect to sustain the growth momentum across our business segments led by biosimilars. We expect to sustain core EBITDA margins despite higher R&D investments to fuel our future growth.” Highlights: Q4FY19  Biologics revenue nearly doubled, led by biosimilars portfolio performance in developed and emerging markets.  Branded Formulations India business reported a strong double digit growth which was offset by a decline in UAE.  Generic Formulations business grew multi-fold off a low base, reflecting our focus on vertical integration in the Small Molecules business  Research Services subsidiary Syngene crossed the Rs 500 Crore Revenue milestone with a Net Profit milestone of Rs 100 Crore in Q4 on a standalone basis.  To commemorate the 40th anniversary of Biocon Limited the Board recommended the issue of 1 bonus share for every 1 share held in Biocon. ]]> <![CDATA[Teva Pharmaceuticals issues voluntary nationwide recall of Losartan Potassium]]> https://biospectrumindia.com/news/95/13477/teva-pharmaceuticals-issues-voluntary-nationwide-recall-of-losartan-potassium.html https://biospectrumindia.com/news/95/13477/teva-pharmaceuticals-issues-voluntary-nationwide-recall-of-losartan-potassium.html Fri, 26 Apr 2019 15:25:00 +0530 Teva Pharmaceuticals USA, Inc. has initiated a voluntary recall in the United States, to the patient level, of 35 lots of bulk Losartan Potassium USP Tablets (6 lots of 25 mg strength and 29 lots of 100 mg strength). This recall is due to the detection of an impurity – N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) – found in six lots of active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited that is above the US Food & Drug Administration’s interim acceptable exposure limit of 9.82 ppm. Based on the available information, the risk of developing cancer in a few patients following long-term use of the product cannot be ruled out. Losartan Potassium is indicated for the treatment of hypertension, hypertensive patients with left ventricular hypertrophy, and nephropathy in Type 2 diabetic patients. The lots were sold exclusively to Golden State Medical Supply of Camarillo, California. Golden State Medical Supply packages this bulk product under its own label and distributes in retail bottles of 30, 90, and 1000 tablets. To date, Teva has not received any reports of adverse events related to the lots being recalled. No other Teva Losartan Potassium finished drug products have been identified, in the United States, containing API above the interim specification levels set for NMBA. The affected Losartan Potassium tablets being recalled are described as: Losartan Potassium tablets, USP 25 mg, are light-green, film-coated, teardrop-shaped biconvex tablet with “LK 25” on one side and ">" on the other side. Losartan Potassium tablets, USP 100 mg, are dark green, film-coated, oval-shaped biconvex tablets with “LK100” on one side and ">" on the other side. Teva promptly notified Golden State Medical Supply of the presence of the impurity in Hetero’s API and Teva will recall thirty-five (35) lots of bulk Losartan Potassium tablets sold to that company. The tablets, which have been packaged and sold by Golden State Medical Supply, will be recalled from their customers and patients. Distributors and retailers that have the product being recalled should immediately stop distribution, quarantine all remaining product in their control, and return the recalled product per the instructions given to them by Golden State Medical Supply. Patients taking Losartan Potassium tablets are advised to continue taking their medication and contact their pharmacist, physician, or medical provider for advice regarding alternative treatment. The immediate risk of harm to a patient’s health is likely to be higher if the medicine is stopped abruptly without any alternative treatment. For full drug product information, please refer to the full prescribing information for Losartan Potassium tablets USP.   ]]> <![CDATA[FDA approves Bausch Health's DUOBRII™ to treat Plaque Psoriasis ]]> https://biospectrumindia.com/news/95/13475/fda-approves-bausch-healths-duobrii-to-treat-plaque-psoriasis-.html https://biospectrumindia.com/news/95/13475/fda-approves-bausch-healths-duobrii-to-treat-plaque-psoriasis-.html Fri, 26 Apr 2019 14:55:00 +0530 Bausch Health Companies Inc. and its dermatology business, Ortho Dermatologics, one of the largest prescription dermatology health care businesses, announced that the U.S. Food and Drug Administration (FDA) has approved the New Drug Application for DUOBRII™ (halobetasol propionate and tazarotene) Lotion, 0.01%/0.045%, indicated for the topical treatment of plaque psoriasis in adults. DUOBRII is the first and only topical lotion that contains a unique combination of halobetasol propionate and tazarotene in one formulation. In a year-long safety study, patients used DUOBRII Lotion for up to 24 weeks of continuous use and up to 52 weeks of as-needed use. DUOBRII is expected to be available in June 2019. When used separately to treat plaque psoriasis, the duration of use of halobetasol propionate is limited by FDA labeling constraints and the use of tazarotene can be limited due to tolerability concerns. By combining halobetasol propionate and tazarotene in an advanced, patented once-daily moisturizing lotion, the DUOBRII formulation ensures uniform distribution, allowing for simultaneous contact with the skin surface. "DUOBRII provides the known benefits of a potent topical corticosteroid and a topical retinoid with synergistic efficacy. Combination therapy is the mainstay of topical treatment for plaque psoriasis, making DUOBRII an important new option," said Linda Stein Gold, M.D., director, Dermatology Clinical Research, Henry Ford Health System. "Although effective, topical retinoids have had limited use as monotherapy due to tolerability concerns. DUOBRII provides improved local tolerability, allowing patients to benefit from an extended duration of use." ]]> <![CDATA[GVK's Mumbai International Airport awarded CEIV Pharma certification]]> https://biospectrumindia.com/news/95/13461/gvks-mumbai-international-airport-awarded-ceiv-pharma-certification.html https://biospectrumindia.com/news/95/13461/gvks-mumbai-international-airport-awarded-ceiv-pharma-certification.html Thu, 25 Apr 2019 14:45:00 +0530 The GVK led Mumbai International Airport Limited (MIAL) becomes the first airport in India and third in Asia to achieve IATA CEIV certification. The certificate is an industry recognition, supporting the air transport industry to comply with pharmaceutical manufacturers’ requirements. The Mumbai International Airport has achieved this quality milestone for Pharma Logistics following successful completion of training courses, on-site assessment, and complex validation processes. Acknowledging the importance of this initiative, MIAL has initiated the certification process in a community approach together with its air cargo supply chain partners. The IATA CEIV Pharma certification was introduced to prevent temperature excursions of Pharma products during air transport with the key objective of patient safety and reduction of losses attributed to logistical issues. Apart from being awarded this key accreditation, GVK MIAL is also a strategic member of ‘Pharma Aero’ and the project lead for ‘Airside Transport Benchmark’. The airport will be soon launching India’s largest Temperature Controlled Solution for the transport of Pharmaceuticals on the Tarmac region. The IATA CEIV aims to improve the handling of Pharmaceutical cargo by complying with existing national and international regulations. The authorization ensures adequately equipped facilities, safety & security, standardization and transparency across the air transport supply chain. GVK Mumbai International Airport Ltd (MIAL) is a Public Private Partnership joint venture between a GVK-led consortium and the Airports Authority of India (AAI). GVK MIAL was awarded the mandate for operating and modernizing Chhatrapati Shivaji Maharaj International Airport, Mumbai (CSMIA). Through this transformational initiative, GVK MIAL aims to make CSMIA one of the world’s best airports, which consistently delights customers besides being the pride of Mumbai. The new integrated Terminal 2 at CSMIA enhances the airport’s capacity to service 40 million passengers and one million tons of cargo annually. ]]> <![CDATA[Glenmark receives approval to market Momate Rhino metered nasal spray ]]> https://biospectrumindia.com/news/95/13456/glenmark-receives-approval-to-market-momate-rhino-metered-nasal-spray-.html https://biospectrumindia.com/news/95/13456/glenmark-receives-approval-to-market-momate-rhino-metered-nasal-spray-.html Thu, 25 Apr 2019 12:55:00 +0530 Glenmark Pharmaceuticals has announced that it has received approval from the Ministry of Healthcare, Russia to market Momate Rhino (Mometasone Furoate 50 mcg) metered nasal spray as an over-the-counter (OTC) product for the treatment of seasonal and perennial allergic rhinitis in patients above 18 years of age. Csaba Kantor, Senior Vice President and Head - Asia, Russia & CIS region, Glenmark Pharmaceuticals said, “Glenmark has built strong capabilities in the area of respiratory and is among the leading players in this therapy in several markets globally. Russia is an important market for us and we are consistently looking to expand product offerings. We believe OTC is an interesting space and this approval for Momate Rhino nasal spray will help enhance our presence in this segment.” Oxana Pozdnyakova, Vice President and Business Head – Russia, Glenmark Pharmaceuticals said, “Allergic rhinitis affects a significant number of people in Russia. The approval to market Momate Rhino as an OTC product paves way for the company to widen patient accessibility of this medicine, which is particularly important at the start of the allergy season.” According to IQVIA, Glenmark ranked 41st in the retail segment of the Russian pharmaceutical market as of MAT February 2019.   ]]> <![CDATA[Alembic’s Bimatoprost gets USFDA approval ]]> https://biospectrumindia.com/news/95/13434/alembics-bimatoprost-gets-usfda-approval-.html https://biospectrumindia.com/news/95/13434/alembics-bimatoprost-gets-usfda-approval-.html Tue, 23 Apr 2019 11:40:00 +0530 Alembic Pharmaceuticals Limited recently announced that the company has received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Bimatoprost Ophthalmic Solution, 0.03%. The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Lumigan, 0.03% of Allergan Sales, LLC (Allergan). Bimatoprost Ophthalmic Solution, 0.03% is indicated for the reduction of elevated intraocular pressure in patients with open angle glaucoma or ocular hypertension. Bimatoprost Ophthalmic Solution, 0.03% have an estimated market size of US$ 10 million for twelve months ending December 2018 according to IQVIA. Alembic now has a total of 90 ANDA approvals (78 final approvals and 12 tentative approvals) from USFDA. ]]> <![CDATA[TB Alliance, Mylan to commercialize pretomanid to treat TB]]> https://biospectrumindia.com/news/95/13429/tb-alliance-mylan-to-commercialize-pretomanid-to-treat-tb.html https://biospectrumindia.com/news/95/13429/tb-alliance-mylan-to-commercialize-pretomanid-to-treat-tb.html Tue, 23 Apr 2019 10:40:00 +0530 Non-profit drug developer, TB Alliance, and pharmaceutical company, Mylan N.V. have announced a global collaboration to make the experimental drug pretomanid accessible for use in two investigational drug regimens for pulmonary tuberculosis (TB). Pretomanid is a new chemical entity and a member of a class of compounds known as nitroimidazooxazines. TB Alliance began preclinical development of pretomanid in 2002, and it has since studied pretomanid in 20 clinical trials alone or in combination with other anti-TB drugs. Pretomanid has been administered in a clinical trial setting to more than 1,200 people in 14 countries. The two pretomanid-based regimens under development include: (i) For XDR-TB and MDR-TB that is treatment-intolerant or non-responsive: All oral, six- to nine-month treatment regimen consisting of bedaquiline, pretomanid and linezolid (BPaL regimen); (ii) For DS-TB and MDR-TB: All oral, four- and six-month treatments, respectively, consisting of bedaquiline, pretomanid, moxifloxacin and pyrazinamide (BPaMZ regimen) As part of the BPaL regimen, TB Alliance has granted a license to Mylan to manufacture and commercialize pretomanid, pending regulatory approval, for XDR-TB and treatment-intolerant or non-responsive MDR-TB. As part of the BPaMZ regimen, TB Alliance has licensed pretomanid to Mylan for DS- and MDR-TB, and has granted a sublicense for bedaquiline to Mylan, for its development and commercialization for use in DS-TB only, under its license agreement with Janssen Pharmaceutica N.V.   ]]> <![CDATA[RegenOrthoSport completes 481 regenerative procedures in two and a half years]]> https://biospectrumindia.com/news/95/13428/regenorthosport-completes-481-regenerative-procedures-in-two-and-a-half-years.html https://biospectrumindia.com/news/95/13428/regenorthosport-completes-481-regenerative-procedures-in-two-and-a-half-years.html Tue, 23 Apr 2019 10:30:00 +0530 RegenOrthoSport, India’s Regenexx center offering advanced stem cell and blood platelet procedures, has completed 481 regenerative procedures in two and a half years. They render non-surgical treatment alternatives for those experiencing joint pain or torn or strained tendons and ligaments, or any other degenerative conditions or common musculoskeletal injuries. Now there is no need to worry about the hassle of surgery for your orthopedic conditions. At RegenOrthoSport, stem cell therapy, and platelet rich plasma therapy are the two main interventional orthopedic treatments available. Regenexx procedures offer a feasible alternative for patients with chronic pain, who may be considering orthopedic surgery. These procedures are an alternative to traditional surgical joint replacements. With this advanced treatment, lost cartilage tissues, meniscus, and torn ligaments can be treated without surgery. Patients return to their loved activities in no time as the procedure involves the stem cells from the patient’s body itself. The stem cell orthopedics procedures can also treat the majority of lifestyle-related conditions like lower back pain, hip arthritis, bulging discs, ankle and shoulder rotator cuff tears, etc. This is the first time India was introduced to the Regenexx procedures that are the most advanced orthopedic stem cell procedures in the world. Against the number of methods conducted in India, Regenexx doctors have performed more than 86000 procedures and are pioneers in the field of Orthopedic Stem Cell Treatments. RegenOrthoSport is a regenerative treatment facility available at Hyderabad and Mumbai in India currently and are the only Regenexx provides in South-east Asia. Considering the increasing count in the number of people suffering from orthopedic and sports conditions, like arthritis and injuries caused due to sports activities, there is a higher demand for non-surgical treatments that ensure better results than the ones existing. To aid this requirement, RegenOrthoSport has extended its scion to provide Knee stem cell therapy in Mumbai after Hyderabad. At RegenOrthoSport treatments for knee, shoulder, elbow, hip, spine, ankle, foot, hand, and wrist under Interventional Orthopedics is provided. The sports medicine, also known as sport and exercise medicine, is a branch of medication in which prevention of injuries related to sports and physical fitness are dealt with. For many years although most sports teams have employed team physicians, sports medicine has emerged as a distinct field of health care only since the late 20th century. RegenOrthoSport provides specialized training and the latest non-invasive therapies and also focuses on both chronic and acute sports injury conditions as well as preventive interventional treatments. RegenOrthoSport has well-trained doctors and therapists who have been trained in Sports Medicine and are board certified in Pain Management. Dr. Venkatesh Movva has his practice, providing various cutting edge treatments while Dr. Apurv Mahalle is a doctor specialized regenerative orthopedics/Interventional Pain Medicine. RegenOrthoSport provides stem cell treatment in Mumbai and Hyderabad. ]]> <![CDATA[analytica Anacon India and India Lab Expo sets strong impression with new records at the Mumbai show]]> https://biospectrumindia.com/news/95/13427/analytica-anacon-india-and-india-lab-expo-sets-strong-impression-with-new-records-at-the-mumbai-show.html https://biospectrumindia.com/news/95/13427/analytica-anacon-india-and-india-lab-expo-sets-strong-impression-with-new-records-at-the-mumbai-show.html Tue, 23 Apr 2019 10:25:00 +0530 The recently concluded 13th edition of analytica Anacon India and India Lab Expo, India’s leading exhibition on laboratory and analytical technologies, held over two days from 16 to 17 April at Bombay Exhibition Centre, Mumbai set new records of visitor and exhibitor participation. The exhibition; spread over 3,500+ sqms, featured 102 global and Indian companies interacting with 4505 visitors which was complemented by 100+ delegates participating in industry specific knowledge enriched seminars. The exhibition gathered best of the technologies pertaining to chromatographs, spectroscopes, microscopes and imaging, bioinformatics, medicine &amp; diagnostics, life sciences, analytical instrumentation systems and laboratory furniture from across the globe. The Mumbai edition attracted numerous trade visitors from pharmaceuticals, chemicals, food processing, biotechnology, healthcare, diagnostics and R&D industry. Bhupinder Singh, Chief Executive Officer of Messe Muenchen India highlights: "analytica Anacon India and India Lab Expo once again proved to be the ideal platform for the matchmaking between buyers and sellers. We are extremely happy with the overall feedback received at the exhibition. Our visitors were able to effectively source their requirements and our exhibitors showcased the latest technologies available in the market. We are all set to welcome all our exhibitors and buyers at our upcoming exhibition in Hyderabad from 19th to 21 st September. “ Supporting program: Buyer-Seller Meetings With over 375 meetings, the Buyer-Seller forum was very well received. Prior to the trade fair, potential customers were able to register for the meetings in order to meet specific exhibitors and initiate new business relationships. The meetings gathered strong participation from Cipla Pharma, Troy Life Sciences, Ritik Healthcare, Arabian Petroleum Limited, Municipal Laboratory (Municipal Corporation), Alkem Laboratories, Aurochem Pharma, Envirocare Labs, Franco IndianPharma, Johnson Mathey Chemicals and Ministry of Defence to name a few. Abhishek Awasthi, International Marketing Manager of Mircrolit commented, “India Lab Expo in Mumbai has been great. We had many visitors from different industries like pharmaceutical, research and governmental institutes along with many channel partners who have visited our stand”100+ delegates participated in analytical and laboratory-specific seminars. The accompanying program; Anacon-JAIMA Technology Showcase and NABL Seminar was well received by 100+ delegates with 10+ speakers sharing their insights on the latest developments in analytical technologies along with an in-depth understanding of the accreditation process and general requirements for the competence of testing and calibration laboratories. Top industry leaders also shared their views on Digitization challenges in manufacturing units and laboratories during the pharma roadshow conducted. Industry trade bodies like Indian Analytical Instruments Association (IAIA), Indian Drug Manufacturers’ Association (IDMA), Bulk Drug Manufacturers’ Association (BDMA), Federation of Telangana and Andhra Pradesh Chambers of Commerce and Industry (FTACCI) also offered their support towards the success of the trade show. Hibiki Kera from Tanaka Scientific one of the exhibitors expressed, “I came to this conference for the first time and was quite impressed with the number of people attending and how the venue is built. We saw a lot of customers coming to our booth as well and it is always nice to be present in all the countries where we sell our products.” ]]> <![CDATA[Lupin gets FDA nod for Fluoxetine Tablets USP]]> https://biospectrumindia.com/news/95/13418/lupin-gets-fda-nod-for-fluoxetine-tablets-usp.html https://biospectrumindia.com/news/95/13418/lupin-gets-fda-nod-for-fluoxetine-tablets-usp.html Mon, 22 Apr 2019 14:40:00 +0530 Pharma major Lupin Limited (Lupin) announced that it has received approval for its Fluoxetine Tablets USP, 10 mg and 20 mg, from the United States Food and Drug Administration (FDA) to market a generic version of Eli Lilly and Company’s (Eli Lilly) Prozac Tablets, 10 mg and 20 mg. Lupin’s Fluoxetine Tablets USP, 10 mg and 20 mg, is the generic version of Eli Lilly’s Prozac Tablets, 10 mg and 20 mg. It is indicated in the treatment of: Major Depressive Disorder (MDD): Fluoxetine is indicated for the acute and maintenance treatment of Major Depressive Disorder in adult patients and in pediatric patients aged 8 to 18 years Obsessive Compulsive Disorder (OCD): Fluoxetine is indicated for the acute and maintenance treatment of obsessions and compulsions in adult patients and in pediatric patients aged 7 to 17 years with Obsessive Compulsive Disorder (OCD) Bulimia Nervosa: Fluoxetine is indicated for the acute and maintenance treatment of binge eating and vomiting behaviors in adult patients with moderate to severe Bulimia Nervosa. Panic Disorder: Fluoxetine is indicated for the acute treatment of Panic Disorder, with or without agoraphobia, in adult patients. Fluoxetine Tablets, 10 mg and 20 mg, (RLD: Prozac) had annual sales of approximately USD 68.2 million in the US (IQVIA MAT December 2018). ]]> <![CDATA[Roche launches Hemlibra in India]]> https://biospectrumindia.com/news/95/13389/roche-launches-hemlibra-in-india.html https://biospectrumindia.com/news/95/13389/roche-launches-hemlibra-in-india.html Sun, 21 Apr 2019 09:00:00 +0530 Roche announced that Emicizumab (Hemlibra) has been approved in India for Haemophilia A with factor VIII inhibitors. It is indicated as a prophylactic(preventive) treatment to prevent or reduce the frequency of bleeding episodes. Hemlibra is the first weekly subcutaneous (under the skin) prophylaxis injection shown to prevent or reduce the frequency of bleeding episodes and improve the quality of life. It is designed to bring together factor IXa and factor X proteins required to activate the natural coagulation cascade and restore the blood clotting process for people with Haemophilia A. All current prophylactic treatment options for people with Haemophilia A with factor VIII inhibitors require intravenous infusions several times a week. Even then, some people may experience joint bleeds that can lead to long-term damage. The approval of Emicizumab is an important advancement for the entire Haemophilia A community. It is a first-in-class of treatments for people with severe Hemophilia A, with inhibitors in nearly 20 years. The clinical evidence of Hemlibra is supported by a comprehensive and extensive development program in Haemophilia A across all ages. “The introduction of Emicizumab (Hemlibra) is a significant milestone in the treatment of Haemophilia A in India and reaffirms our commitment to bring Roche's groundbreaking medicines to patients in India as early as possible,” said Lara Bezerra, Chief Purpose Officer (MD), Roche Pharma India. “This break-through medicine represents a completely new way to manage haemophilia Aand redefines the standard of care. With this new therapy, patients now have a stronger chance of leading a healthy and active life.” According to the World Federation of Haemophilia, India records for the highest number of Haemophilia patients in the world. With the current birth rate in India being 32/1000, 1,300 new patients with Haemophilia are born each year. As of 2018 estimates, there are about 50,000 patients suffering from Hemophilia, of which 20,000 people have been identified and there are still about 30,000 unidentified people with Haemophilia in India.  Lack of disease awareness and inadequate infrastructure result in high rates of under-diagnosis and sub-optimal treatment, both of which strongly influence not only the quality of life but also the lifespan of people with Hemophilia. Hemlibra is approved by multiple regulatory authorities across the world and is now also approved and available in India. In the HAVEN 1 pivotal Phase III clinical study, 62.9% of patients had zero bleeds with Hemlibra prophylaxis. In the HAVEN 2 study, 87% of pediatric patients had zero treated bleeds.   ]]> <![CDATA[Granules India gets US FDA approval for Acetaminophen]]> https://biospectrumindia.com/news/95/13409/granules-india-gets-us-fda-approval-for-acetaminophen.html https://biospectrumindia.com/news/95/13409/granules-india-gets-us-fda-approval-for-acetaminophen.html Sat, 20 Apr 2019 20:00:00 +0530 Granules India Ltd has announced that the US FDA has approved its Abbreviated New Drug Application (ANDA) for Acetaminophen 650 mg Tablets, Extended Release, bioequivalent to the reference listed drug product (RLD), Tylenol 650mg tablets, Extended Release. Acetaminophen 650 mg extended release tablets are used primarily for temporary pain management including arthritis relief. “The addition of Acetaminophen 650mg, extended release tablets to our OTC portfolio leverages several components of our value proposition. Granules’ is the only supplier that is backward integrated up to the API on this product. Our vertically integrated approach will enable us to provide a high-quality, cost-efficient product that benefit consumers. With a capacity of over 24,000 mt/year of Acetaminophen API and finished dosage capacity of more than 18 billion units/year, we are confident that we will ensure supply security to our customers which will support us to capture our target market share,” said Mr. Krishna Prasad Chigurupati, Chairman & Managing Director of Granules India. Granules India is a growing pharmaceutical manufacturing company with best in class facilities and is committed to operational excellence, quality and customer service. The Company produces Finished Dosages (FDs), Pharmaceutical Formulation Intermediates (PFIs) and Active Pharmaceutical Ingredients (APIs) which gives the customers flexibility and choice. Granules support customers with unique value, extensive product range, and proactive solutions. The Company’s global presence extends to over 250 customers in 60 countries through offices in India, U.S., and U.K. The Company has 8 manufacturing facilities out of which 6 are located in India, 1 in China and 1 in USA and has regulatory approvals from US FDA, EDQM, EU GMP, COFEPRIS, WHO GMP, TGA, K FDA, DEA, MCC and HALAL. ]]> <![CDATA[GakSung Global celebrates its India Foundation Day ]]> https://biospectrumindia.com/news/95/13405/gaksung-global-celebrates-its-india-foundation-day-.html https://biospectrumindia.com/news/95/13405/gaksung-global-celebrates-its-india-foundation-day-.html Fri, 19 Apr 2019 12:25:00 +0530 GakSung Global recently celebrated its India Foundation Day in New Delhi. Chaired by Cho Je Yun, the Global CMD of GakSung World, the celebration was attended by over 500 Gaksung customers and health facilitators. The customers also experienced the latest Low Level Laser therapies sessions with GakSung World. Cho Je Yun said, “LLLT has become a synergistic approach in alternative healthcare ensuring the best treatment for all kinds of diseases and health issues. From Musculoskeletal, Cancer, and Brain Injuries to the treatment of tuberculosis, mucositis, migraine, and hair loss, our wide range of LLLT based products have established a successful treatment record.” GakSung World is providing Low-Level Laser Therapy (LLLT) with the combination of Thermal therapy which is highly accepted and appreciated in European and many other countries. The products are presently being used in the Neurology Department at KGMC hospital in Lucknow, and many other renowned hospitals as well. The Indian operations of the company are carried out from it’s headquarter based in New Delhi under the leadership of Ranjan Ojha. ]]> <![CDATA[India to be one of the world’s ‘fastest growing bio’ hubs in 2019: CPhI data ]]> https://biospectrumindia.com/news/95/13401/india-to-be-one-of-the-worlds-fastest-growing-bio-hubs-in-2019-cphi-data-.html https://biospectrumindia.com/news/95/13401/india-to-be-one-of-the-worlds-fastest-growing-bio-hubs-in-2019-cphi-data-.html Thu, 18 Apr 2019 14:50:00 +0530 New data from CPhI shows that, despite ongoing reputational challenges, India’s biologics market is set for robust growth in 2019 driven by biosimilars production. The India specific findings from CPhI’s bio league tables predict strong ‘bio growth potential’ in India throughout 2019 in the build-up to the 13th edition of CPhI India 2019, which will take place at the India Expo Centre in Delhi NCR. However, highlighting the market’s ambivalent reputation, India also received the second lowest overall scores for ‘quality of biologics manufacturing’ and ‘biologics innovation’. Yet for ‘growth potential’ India (7.05) scored extremely highly, finishing broadly level with the well-established advanced bio markets Germany (7.2), Ireland (7.2) and Japan (7.3), and behind only the United States (7.8) – but significantly, ahead of China (6.9) and its widely documented rapidly expanding bio sector. India’s growing biosimilars industry is the primary driver of growth, with respondents citing ‘India’s rising domestic demand, bio investments and the potential for increased exports to advanced markets’.  Already, India has over 70 approved biosimilars in the domestic market (more than any other country) and market penetration – which is currently relatively low – is expected to increase quickly in 2019 as the middle classes increase demand. This growth potential is augmented by government subsidies for production of biosimilars, expiration of existing biologics patents and India’s Central Drugs Standard Control Organisation aligning guidelines closely with other regulators such as the US FDA. In fact, the Associated Chambers of Commerce of India 2017 report predicts that the biosimilars market in India was worth $2.2bn and is expected to reach an astonishing $40bn by 2030. Cara Turner, Brand Director, Pharma, commented; “CPhI and P-MEC India has been extremely successful and we announced before the event that India had secured the number one spot for growth potential of small molecules in 2019. These new findings however, show that biosimilars are also set for dramatic growth in 2019 and that India is expected to be amongst the fastest growing bio regions. In fact, over the next few years we anticipate seeing more bio machinery manufacturers attending P-MEC and a steady growth in our bio audiences.” Demand in Europe and the USA is expected to sustain longer term growth rates as these markets open-up further to biosimilar encroachment and encourage new entrants. Undoubtedly, the lower cost of manufacturing in India makes biosimilars exports attractive to Western markets. Initial market entry may be slowed by high clinical development costs – which can be as much as $150million for an approval in the United States. As a result, it is predicted that in 2019 we will see a greater number of Western-Indian partnerships (aka the Mylan-Biocon model) jointly bringing new biosimilars to patients in both the EU and USA. The research highlighted that unlike its small molecule industry – which improved rapidly in the 2018 league tables – the bio industry in India is still viewed by international pharma as substantially behind the leading markets in terms of quality and innovation. Notably, the top ranked nations of the United States, Germany, and Japan, and the second tier of advanced nations, Sweden, Ireland, Switzerland, the UK, France and Korea. The relatively low score for both quality (6.0) and innovation (6.0) is probably reflective of the lack of any patented biologic development in India, with the majority of this work being retained in Europe and the United States. However, the nation did score intermediately for ‘knowledge of its bio professionals’ (6.6) and its ‘ability to meet future capacity requirements’ (6.7) – suggesting that there is more than adequate facilities built or under construction to meet rising future demand. Rahul Deshpande, Group Director, UBM India added, “What is most exciting is that we’ll be returning to a single site event taking place in the nation’s capital Delhi, bringing together regulators, industry and international pharma in what will have been a record-breaking year for the pharma industry in India”. CPhI & P-MEC India 2019 will be returning to the India Expo Centre in the nation’s capital for the second time.   ]]> <![CDATA[Merck launches drug compound to treat and prevent Folate deficiencies]]> https://biospectrumindia.com/news/95/13398/merck-launches-drug-compound-to-treat-and-prevent-folate-deficiencies.html https://biospectrumindia.com/news/95/13398/merck-launches-drug-compound-to-treat-and-prevent-folate-deficiencies.html Thu, 18 Apr 2019 12:40:00 +0530 Merck has launched a new and improved proprietary product: Arcofolin™ L-Methylfolate, a monosodium salt of L-5-methyltetrahydrofolic acid for nutritional and pharmaceutical applications.  Identical to the naturally occurring predominant form of folate, Arcofolin™ L-Methyfolate provides supplementation aimed at enriching the diet with natural folate. Low levels of folate have been associated with various disorders including anemia, neural tube defects, depression and osteoporosis. It can be difficult to meet the recommended daily folate intake with food alone, as large amounts of food folate can be lost during processing and cooking. Dietary supplements bridge that gap.  Arcofolin™ L-Methylfolate is an active form of vitamin B9, also known as folic acid. Unlike folic acid, this biologically active form of folate is easy for the body to metabolize: its unique formula does not require any extra steps to be absorbed and enter circulation once ingested.  Dietary supplement and pharmaceutical manufacturers can benefit from the compound’s high active folate content, enhanced water solubility, higher purity and improved overall stability. Arcofolin™ L-Methylfolate is protected against generics due to comprehensive intellectual property protection (patent pending).  Merck’s Arcofolin™ L-Methylfolate is developed and produced under cGMP conditions in a U.S. FDA- and Swissmedic-inspected facility using advanced manufacturing technologies. Merck launched Metafolin® L-Methylfolate in 2001 as the first commercially available form of the naturally occurring folate vitamer. This ingredient is aimed at helping millions of people around the world maintain sufficient folate levels in all stages of life.   Merck provides the most comprehensive portfolio of high-quality folates for nutritional and pharmaceutical applications as well as excipients and drug delivery compounds to meet the industry’s formulation needs, with the right documentation at the right time. ]]> <![CDATA[Cipla Medpro acquires a stake in Brandmed]]> https://biospectrumindia.com/news/95/13394/cipla-medpro-acquires-a-stake-in-brandmed.html https://biospectrumindia.com/news/95/13394/cipla-medpro-acquires-a-stake-in-brandmed.html Thu, 18 Apr 2019 11:45:00 +0530 In recognition of the importance of the critical shift to a more patient-centric, integrated and predictive healthcare environment, Cipla Medpro South Africa will acquire a 30% stake upon closure in the connected healthcare company, Brandmed. In February, Cipla had announced a similar partnership in India with Wellthy Therapeutics to offer a clinically-validated digital disease management platform to patients in cardio-metabolic health. Following the Definitive Agreement, Cip Tec will make an upfront payment of $22 million to Pulmatrix in exchange for assignment of all rights for Pulmazole in relation to pulmonary indications to Cip Tec. Thereafter, both parties will equally share costs related to the future development and commercialization of Pulmazole, and equally share worldwide free cash flow from future sales of Pulmazole. Pulmatrix will remain primarily responsible for the execution of the clinical development of Pulmazole, and Cip Tec will be responsible for the commercialization of the product. The partnership will be overseen by a Joint Steering Committee with equal representation from both companies.  Brandmed, founded in 2014, has developed a fully integrated end to end solution to address outcomes and value-based care for patients with chronic lifestyle and Non-Communicable- Diseases (NCDs) such as hypertension, diabetes, high cholesterol, asthma and chronic obstructive pulmonary disease. KardioGroup, a subsidiary of Brandmed was awarded the prestigious Frost & Sullivan South African Product Line Strategy Leadership, Internet of Medical Things South Africa, award in 2019. The Brandmed ecosystem, developed in South Africa, seamlessly integrates a combination of connected solutions across the health continuum for patients, healthcare professionals, practices and institutions, and aims to deliver personalised patient care.  Paul Miller, CEO of Cipla Medpro said, “This transaction will help to transition healthcare from being reactive to a proactive and real-time monitoring model that focuses on promoting wellness instead of managing illness. This aligns with Cipla’s vision and focus on ‘human care’ and a future where good health is expected, not for the few, but for the many.” “By pairing our strengths with Brandmed’ s innovative, patient centric approach to healthcare, Cipla Medpro will enhance its diverse portfolio in the NCD area to provide holistic care to patients from awareness through to disease management, thereby enabling patient adherence and compliance.”  The brainchild behind Brandmed, cardiologist Dr Riaz Motara said, “Drugs alone are not enough to manage a disease and the disease burden will become unmanageable unless innovative solutions are implemented.” “We’re integrating medical expertise with ground-breaking technology to deliver better patient care and offer an integrated disease management solution. We’re also shifting the focus from managing diseases in separate silos to a comprehensive risk reduction and treatment approach. Greater success in patient health outcomes, value-based care and efficiencies could be achieved in South Africa if more healthcare stakeholders are willing to work together,” said Motara. The Indigo Wellness Index report reveals that South Africa has tremendous scope for improvement on various health indicators. Measures captured included healthy life expectancy, blood pressure, blood glucose (diabetes risk), obesity, depression, happiness, alcohol use, tobacco use, inactivity (too little exercise), and government spending on healthcare. According to the World Health Organisation, NCDs – mainly cardiovascular diseases, cancers, chronic respiratory diseases, and diabetes – are the leading cause of death worldwide. More than 38 million people die annually from NCDs (63% of global deaths), including 16 million people who die before the age of 70. Nearly 50% of global disability is attributed to NCDs. Reducing the avoidable burden caused by NCDs and their risk factors means taking actions now to change the narrative around NCDs.   ]]> <![CDATA[Digene launched a campaign focusing on lifestyle-related hyperacidity ]]> https://biospectrumindia.com/news/95/13393/digene-launched-a-campaign-focusing-on-lifestyle-related-hyperacidity-.html https://biospectrumindia.com/news/95/13393/digene-launched-a-campaign-focusing-on-lifestyle-related-hyperacidity-.html Thu, 18 Apr 2019 11:30:00 +0530 In order to meet the underlying need and reach a broader audience, Digene has launched a new campaign focusing on providing a scientific solution to lifestyle-related hyperacidity, with Tapsee Pannu who talks about the issues related to life-style related hyperacidity. She represents the challenges and problems faced by modern day consumers. New market research shows that lifestyle-related hyperacidity is a growing concern for consumers. In fact, 61 per cent of the population in urban India suffers from hyperacidity at some point in time. Abbott’s Digene, one of the key antacid brands in the country, is a scientifically proven solution to hyperacidity for modern-day hectic lifestyles. While hyperacidity has traditionally been associated by consumers with life-stage or body type, new market research shows that consumers believe hyperacidity is increasingly rooted in the lifestyle they lead. Due to the pressures of urban life, consumers report consumption of more culprit foods than ever, erratic eating habits and an increase in stress and tension. And data from one study found that nearly 70 per cent of acid reflux patients were aged below 50 years. This indicates that hyperacidity and related conditions are increasingly being driven by lifestyle factors and are thus more prevalent among younger populations. Dr. Srirupa Das, Director, Medical Affairs at Abbott explains, “Digene provides fast and effective relief based on science, with active ingredients that relieve symptoms and protect the stomach lining. This translates into better relief – which means people can get back to living their life.” Commenting on the scientific approach presented to younger consumers, Ambati Venu, Managing Director, Abbott India Limited said, “Research indicates one of the leading causes of hyperacidity is hectic and erratic lifestyle, which is common among today’s urban consumers. Digene is an effective solution that is trusted by most doctors in India. Importantly, the product is backed by science through its high acid neutralizing capacity. As we further grow our consumer portfolio in the country, Abbott is committed to providing scientific solutions to help people get and stay healthy.” Digene has been available in India for nearly 90 years, and is mostly prescribed antacid among doctors. Moreover, its efficacy is rooted in science. It has what is called high acid neutralizing capacity (ANC), which means it is very effective at reducing the acid in a person’s stomach to give them relief.   ]]> <![CDATA[Zydus Cadila announces phase III trial of Desidustat]]> https://biospectrumindia.com/news/95/13388/zydus-cadila-announces-phase-iii-trial-of-desidustat.html https://biospectrumindia.com/news/95/13388/zydus-cadila-announces-phase-iii-trial-of-desidustat.html Wed, 17 Apr 2019 14:20:00 +0530 Zydus Cadila, an innovation-driven, global pharmaceutical company, announced the Phase III trials of Desidustat, an Investigational New Drug targeted at treating anemia in non-dialysis dependent chronic kidney disease (NDD-CKD) patients. This Phase III study will be a multicenter (50- 60 sites), randomized, active-controlled clinical trial to evaluate the efficacy and safety of Desidustat versus Darbepoetin for the treatment of anaemia in patients with chronic kidney disease (CKD) who are not on dialysis. Speaking on the development, Mr. Pankaj R. Patel, Chairman, Zydus Group said, “This innovation has the potential to bring about a paradigm shift in the management of CKD patients with anemia. An HIF-PH inhibitor could provide an oral, safer alternative to currently available erythropoietinstimulating agents (ESAs), which are associated with increased risk of cardiovascular events and have to be given via injections and a cold chain has to be maintained. This is a significant milestone in our research journey.” Earlier, Desidustat had met its primary endpoints in the Phase II clinical study of Non-dialysis dependent Chronic Kidney Disease (NDD-CKD) patients suffering from anemia. The Phase II NDD-CKD study was a randomized, double-blind, placebo-controlled study of the efficacy and safety of Desidustat for the treatment of anemia in CKD patients not on dialysis. ]]> <![CDATA[Cipla with Pulmatrix to develop and commercialize Pulmazole]]> https://biospectrumindia.com/news/95/13372/cipla-with-pulmatrix-to-develop-and-commercialize-pulmazole.html https://biospectrumindia.com/news/95/13372/cipla-with-pulmatrix-to-develop-and-commercialize-pulmazole.html Tue, 16 Apr 2019 11:00:00 +0530 Cipla Technologies LLC , a subsidiary of Cipla Limited along with its subsidiaries( "Cipla") and Pulmatrix, Inc. a clinical stage biopharmaceutical company focused on developing novel inhaled therapeutics to serve unmet needs in respiratory disease, have announced their entry into a Definitive Agreement for the co-development and commercialization of Pulmazole (PUR1900) – an inhaled iSPERSE™ formulation of the antifungal drug itraconazole for the treatment of allergic bronchopulmonary aspergillosis (ABPA) in patients with asthma.  Following the Definitive Agreement, Cip Tec will make an upfront payment of $22 million to Pulmatrix in exchange for assignment of all rights for Pulmazole in relation to pulmonary indications to Cip Tec. Thereafter, both parties will equally share costs related to the future development and commercialization of Pulmazole, and equally share worldwide free cash flow from future sales of Pulmazole. Pulmatrix will remain primarily responsible for the execution of the clinical development of Pulmazole, and Cip Tec will be responsible for the commercialization of the product. The partnership will be overseen by a Joint Steering Committee with equal representation from both companies.   With the signing of the Definitive Agreement, Pulmatrix is in a strong position to complete the Phase 2 study entitled: ‘A Randomized, Double-Blind, Multicenter, Placebo Controlled, Phase 2 Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Itraconazole Administered as a Dry Powder for Inhalation (PUR1900) in Adult Asthmatic Patients with Allergic Bronchopulmonary Aspergillosis (ABPA)’. Pulmatrix plans to initiate this study in April 2019.   ]]> <![CDATA[Suven secures product patents in Israel, Japan, NZ, SL]]> https://biospectrumindia.com/news/95/13356/suven-secures-product-patents-in-israel-japan-nz-sl.html https://biospectrumindia.com/news/95/13356/suven-secures-product-patents-in-israel-japan-nz-sl.html Tue, 16 Apr 2019 09:00:00 +0530 Suven Life Sciences Ltd (Suven) has announced that the grant of one (1) product patent from Israel (257869), one (1) product patent from Japan (6466602), one (1) product patent from New Zealand (737892) and one (1) product patent from Sri Lanka (16614) corresponding to the New Chemical Entities for the treatment of disorders associated with Neurodegenerative diseases and patents are valid through 2036 and 2029 respectively. The granted claims of the patents include the class of selective 5-HT4 and M1 PAM compounds and are being developed as therapeutic agents for neurodegenerative disorders such as for the treatment of cognitive impairment associated with neurodegenerative disorders like Alzheimer’s disease, Attention deficient hyperactivity disorder (ADHD), Huntington’s disease, Pain, Parkinson Disease and Schizophrenia etc. “We are very pleased by the grant of these patents to Suven for our pipeline of molecules in CNS arena that are being developed for cognitive disorders with high unmet medical need with huge market potential globally” says Venkat Jasti, CEO of Suven. ]]> <![CDATA[TA Associates announces partnership with Indira IVF]]> https://biospectrumindia.com/news/95/13369/ta-associates-announces-partnership-with-indira-ivf.html https://biospectrumindia.com/news/95/13369/ta-associates-announces-partnership-with-indira-ivf.html Mon, 15 Apr 2019 15:35:00 +0530 TA Associates, global growth private equity firm has announced that it has completed a significant minority investment in Indira IVF, a leading India-based infertility treatment provider. Financial terms of the transaction were not disclosed. Founded in 2014, Indira IVF currently operates 59 centers across 16 states in India and has completed nearly 27,000 IVF cycles in the last 12 months. Naresh Patwari, a Director at TA Associates Advisory Private Limited said, “We are excited about the opportunity to partner with Indira IVF, a leader in IVF in India that aims to provide affordable, high-quality IVF services, while delivering best-in-class clinical outcomes. IVF is a large and fast-growing opportunity in India that we believe has the ability to make a lasting positive impact on the lives of millions of people. We look forward to working with Dr. Ajay Murdia and the management team at Indira IVF to help them continue their growth efforts in India and in international markets, both organically and inorganically, and to help them offer additional adjacent clinical services.” Dr. Ajay Murdia, Founder and Chairman of Indira IVF said, “We have built a strong relationship with the TA Associates team. TA has made many investments in healthcare services businesses, both in India and globally, and has a deep understanding of our industry. We believe that our partnership with TA will help Indira IVF enhance its mission of providing world-class IVF services at affordable rates with best-in-class clinical outcomes, while simultaneously maintaining our patient-first approach and sharp focus on clinical excellence. We welcome TA to Indira IVF, and look forward to a successful, long-term partnership.” Dhiraj Poddar, a Managing Director at TA Associates Advisory Private Limited said, “The infertility treatment space, in particular IVF, represents a large and growing market. We look forward to this partnership with Indira IVF and are thrilled to be supporting this seasoned, talented and passionate team of professionals to help Indira IVF enter into its next phase of growth.” Naresh Patwari and Dhiraj Poddar will join the Board of Directors of Indira IVF as nominee directors of TA Associates Advisory Private Limited. Pioneer Legal (previously with DSK Legal) provided legal counsel and KPMG served as financial advisor to TA Associates. Veritas Legal provided legal counsel to Indira IVF. TA Associates Advisory Private Limited provided advisory services on the investment.     ]]> <![CDATA[Suven receives court approval to buy assets of Rising Pharmaceuticals]]> https://biospectrumindia.com/news/95/13368/suven-receives-court-approval-to-buy-assets-of-rising-pharmaceuticals.html https://biospectrumindia.com/news/95/13368/suven-receives-court-approval-to-buy-assets-of-rising-pharmaceuticals.html Mon, 15 Apr 2019 15:05:00 +0530 Suven Life Sciences Limited, a biopharmaceutical company provider of Contract Research and Manufacturing Services (CRAMS) for global life science companies, has received the US Bankruptcy Court approval of “Stalking Horse” Agreement to buy the assets of Rising Pharmaceuticals through its joint venture partner Shore Suven Pharma Inc. The sale was conducted through a Court-supervised process under Section 363 of the Bankruptcy Code. Under that process, Shore Suven Pharma’s purchase agreement served as the “stalking horse agreement” and an auction would have been conducted had the Company received qualified offers from other bidders reflecting potentially higher and/or otherwise better terms. No such bids were received prior to the bid deadline. Therefore, no auction was conducted and Shore Suven Pharma was selected as the successful bidder for the Rising Pharmaceuticals on March 29, 2019.The transaction is expected to close on April 19, 2019, subject to the satisfaction of certain other conditions.  “This Court approval brings closure to the sale process for Rising Pharmaceuticals and paves the way for a seamless transition of the portfolio, customer programs and manufacturing and drug development relationships to Shore Suven Pharma Inc. which in turn will pave the way for continuity of product supply to the customers,” said Mr. Venkat Jasti, CEO of Suven Life Sciences Ltd. “We are very pleased to have completed a “stalking-horse” agreement to buy the assets of Rising Pharmaceuticals through this court approval process. This acquisition of Rising’s assets would transform Shore Suven Pharma into a strong U.S. generic pharmaceutical company. Leveraging Rising’s extensive product portfolio and vertically integrating with Suven’s world class API and finished dose manufacturing capabilities will enable us to better serve U.S. customers,” said Mr. Vimal Kavuru, CEO of Shore Suven Pharma Inc. ]]> <![CDATA[Dr. Reddy's announces acquisition of ANDA portfolio]]> https://biospectrumindia.com/news/95/13366/dr-reddys-announces-acquisition-of-anda-portfolio.html https://biospectrumindia.com/news/95/13366/dr-reddys-announces-acquisition-of-anda-portfolio.html Mon, 15 Apr 2019 14:00:00 +0530 Dr. Reddy’s Laboratories Ltd., along with its subsidiaries together referred to as “Dr. Reddy’s” has entered into a definitive agreement to acquire a portfolio of 42 approved, non-marketed Abbreviated New Drug Applications (ANDAs) in the U.S. The portfolio includes more than 30 generic injectable products. These products will require to be technology transferred and could be launched within the next one to two years. The value of total addressable market for these products in the U.S. is approximately $645 million for the calendar year ending in December 2018 according to IQVIA. Erez Israeli, Chief Operating Officer of Dr. Reddy’s Laboratories, commented, “The acquisition is in line with our stated strategy to significantly enhance our portfolio in our chosen growth markets. This transaction will help augment our injectables product portfolio in the U.S. market and globally.” ]]> <![CDATA[Lupin launches Testosterone Gel]]> https://biospectrumindia.com/news/95/13365/lupin-launches-testosterone-gel.html https://biospectrumindia.com/news/95/13365/lupin-launches-testosterone-gel.html Mon, 15 Apr 2019 12:00:00 +0530 Lupin has announced the launch of Testosterone Gel, 1.62% (20.25 mg/1.25 g pump actuation), having received an approval from the United States Food and Drug Administration (FDA). Lupin’s Testosterone Gel, 1.62% (20.25 mg/1.25 g pump actuation), is the generic equivalent of AbbVie Inc’s AndroGel, 1.62%. It is indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone Primary hypogonadism (congenital or acquired) and Hypogonadotropic hypogonadism (congenital or acquired) Testosterone Gel, 1.62% (20.25 mg/1.25 g pump actuation) had an annual sales of approximately USD 893 million in the US (IQVIA MAT December 2018). ]]> <![CDATA[Cipla lauches ICS-LABA combination HFA inhaler Niveoli]]> https://biospectrumindia.com/news/95/13355/cipla-lauches-ics-laba-combination-hfa-inhaler-niveoli.html https://biospectrumindia.com/news/95/13355/cipla-lauches-ics-laba-combination-hfa-inhaler-niveoli.html Fri, 12 Apr 2019 16:30:00 +0530 Cipla has announced that it has  launched Niveoli, India’s first extra-fine particle beclomethasone-formoterol combination hydrofluoroalkane (HFA) inhaler for adults, targeting drug delivery to the small airways. Niveoli is a proprietary Cipla inhaler, and the latest offering from Cipla in respiratory inhalation therapy that addresses an unmet need associated with obstructive airway diseases (OAD) such as asthma and chronic obstructive pulmonary disorder (COPD). Asthma and COPD are lung conditions that affect the ability to breathe. Extensive research and an evolved understanding of the diseases over the years has shown the significant role of small airway disease in asthma and COPD. A recent meta-analysis showed that small airway disease is prevalent in 50-60% of asthma patients. Another study has indicated that routine lung function tests can underestimate problems in the small airways[2]. Small airway disease is a common feature of COPD and gets worse with increasing severity of the condition. Niveoli’s novelty and strength lies in HFA propelled delivery of extra-fine particles of beclomethasone, an inhaled corticosteroid (ICS) and formoterol, a fast-onset long acting beta agonist (LABA) to the small airways. Commenting on the launch, Nikhil Chopra, Head – India business, Cipla, said, “Cipla is pleased to offer yet another milestone in respiratory inhalation therapy. Niveoli™ marks a first in acknowledging and addressing the issue of drug delivery to the small airways. Cipla has a long history of blazing the trail in innovations in combination formulations and drug-device combinations in the respiratory therapy, and Niveoli™ is a painstaking result of these strengths. Be it the transparent dry powder inhaler, the static-free spacer with valve mechanism, the mask-spacer combination for children or our novel breath-actuated inhaler with dose counter called Synchrobreathe™, the list is long. We see our market leadership as well as the range and depth of our R&D and manufacturing capabilities in this therapy as a privilege and a responsibility to do more for patients. In keeping with our purpose of ‘Caring for Life’, we are constantly studying OADs and working towards products that offer greater efficacy, ease of use and drug delivery to patients. I believe Niveoli represents a new paradigm in inhalation therapy.”  ]]> <![CDATA[Sandoz to sell Rizmoic in Germany, UK and Netherlands]]> https://biospectrumindia.com/news/95/13347/sandoz-to-sell-rizmoic-in-germany-uk-and-netherlands.html https://biospectrumindia.com/news/95/13347/sandoz-to-sell-rizmoic-in-germany-uk-and-netherlands.html Fri, 12 Apr 2019 13:15:00 +0530 Sandoz recently announces that it has signed an agreement with Shionogi & Co Ltd for commercialization of Rizmoic® (naldemedine) in the key European markets of Germany, the UK and the Netherlands, plus right of first refusal for certain other European markets.  Rizmoic®, a once-daily 200-microgram oral tablet discovered and developed by Shionogi, is an innovative medicine indicated to treat opioid induced constipation (OIC) in adult patients previously treated with a laxative. Shionogi announced on February 22, 2019 that it had received EU marketing authorization for Rizmoic®. OIC is a prevalent and distressing side-effect of opioid therapy that does not respond reliably to treatment with conventional laxatives. Sandoz has a strong presence in the European market for anti-pain therapeutics, as well as a complementary strategic focus on innovative therapeutic alternatives to combat opioid dependency. This year saw the US launch of two such products, including the first prescription digital therapeutic in this field. Under the terms of the agreement, Sandoz will be responsible for commercializing Rizmoic® in Germany, the UK and the Netherlands and Shionogi will be responsible for its manufacturing and development. Further details of the deal are not being disclosed. ]]> <![CDATA[Cipla launches Niveoli inhaler ]]> https://biospectrumindia.com/news/95/13344/cipla-launches-niveoli-inhaler-.html https://biospectrumindia.com/news/95/13344/cipla-launches-niveoli-inhaler-.html Fri, 12 Apr 2019 10:20:00 +0530 Cipla has announced that it has launched Niveoli™, India’s first extra-fine particle beclomethasone-formoterol combination hydrofluoroalkane (HFA) inhaler for adults, targeting drug delivery to the small airways. Niveoli™ is a proprietary Cipla inhaler, and the latest offering from Cipla in respiratory inhalation therapy that addresses an unmet need associated with obstructive airway diseases (OAD) such as asthma and chronic obstructive pulmonary disorder (COPD). Asthma and COPD are lung conditions that affect the ability to breathe. Extensive research and an evolved understanding of the diseases over the years has shown the significant role of small airway disease in asthma and COPD. A recent meta-analysis showed that small airway disease is prevalent in 50-60% of asthma patients. Commenting on the launch, Nikhil Chopra, Head – India business, Cipla, said, “Cipla is pleased to offer yet another milestone in respiratory inhalation therapy. Niveoli™ marks a first in acknowledging and addressing the issue of drug delivery to the small airways. Cipla has a long history of blazing the trail in innovations in combination formulations and drug-device combinations in the respiratory therapy, and Niveoli™ is a painstaking result of these strengths. Be it the transparent dry powder inhaler, the static-free spacer with valve mechanism, the mask-spacer combination for children or our novel breath-actuated inhaler with dose counter called Synchrobreathe™, the list is long. We see our market leadership as well as the range and depth of our R&D and manufacturing capabilities in this therapy as a privilege and a responsibility to do more for patients. In keeping with our purpose of ‘Caring for Life’, we are constantly studying OADs and working towards products that offer greater efficacy, ease of use and drug delivery to patients. I believe Niveoli™ represents a new paradigm in inhalation therapy.”  Another study has indicated that routine lung function tests can underestimate problems in the small airways. Small airway disease is a common feature of COPD and gets worse with increasing severity of the condition. Niveoli™’s novelty and strength lies in HFA propelled delivery of extra-fine particles of beclomethasone, an inhaled corticosteroid (ICS) and formoterol, a fast-onset long acting beta agonist (LABA) to the small airways.   ]]> <![CDATA[Lupin receives FDA approval for Testosterone Gel]]> https://biospectrumindia.com/news/95/13338/lupin-receives-fda-approval-for-testosterone-gel.html https://biospectrumindia.com/news/95/13338/lupin-receives-fda-approval-for-testosterone-gel.html Thu, 11 Apr 2019 12:50:00 +0530 Pharma major Lupin has announced that it has received approval for its Testosterone Gel, 1.62% (20.25 mg/1.25 g pump actuation), from the United States Food and Drug Administration (FDA) to market a generic version of AbbVie, Inc’s (AbbVie) AndroGel 1.62%. Lupin’s Testosterone Gel, 1.62% (20.25 mg/1.25 g pump actuation), is the generic equivalent of AbbVie’s AndroGel, 1.62%. It is indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone: Primary hypogonadism (congenital or acquired) and Hypogonadotropic hypogonadism (congenital or acquired) Testosterone Gel, 1.62% (20.25 mg/1.25 g pump actuation), (RLD: AndroGel) had annual sales of approximately USD 893 million in the US (IQVIA MAT December 2018). Lupin is an innovation led transnational pharmaceutical company developing and delivering a wide range of branded & generic formulations, biotechnology products, and APIs globally. The Company is a significant player in the Cardiovascular, Diabetology, Asthma, Pediatric, CNS, GI, Anti-Infective and NSAID space and holds the global leadership position in the Anti-TB segment. Lupin is the 8th largest generics pharmaceutical company in terms of market capitalization (28th December 2018, Bloomberg) and the 8th largest generics pharmaceutical company in terms of revenues (30th September 2018, Bloomberg LTM) globally. The Company is the 3rd largest pharmaceutical player in the US by prescriptions for the Total Market (IQVIA MAT December 2018); 3rd largest Indian pharmaceutical company by global revenues (30th September 2018, Bloomberg LTM); 6th largest generic pharmaceutical player in Japan (IQVIA MAT December 2018) and 5th largest company in the Indian Pharmaceutical Market (IQVIA MAT December 2018). For the financial year ended 31st March, 2018, Lupin’s Consolidated sales and Net profits before exceptional items were at Rs. 155,598 million (USD 2.41 billion) and Rs. 13,934 million (USD 216 million) respectively.     ]]> <![CDATA[Wockhardt receives US FDA approval for cancer drug]]> https://biospectrumindia.com/news/95/13334/wockhardt-receives-us-fda-approval-for-cancer-drug.html https://biospectrumindia.com/news/95/13334/wockhardt-receives-us-fda-approval-for-cancer-drug.html Thu, 11 Apr 2019 11:05:00 +0530 Pharmaceutical and biotechnology major Wockhardt has received approval from the United States Food & Drug Administration (US FDA) for an ANDA for 50mg injection of Decitabine, which is used to treat certain forms of cancer. Wockhardt’s Decitabine Injection is a generic version of Dacogen®, marketed in USA and other countries by Otsuka. Decitabine is used to treat Myelodysplastic syndromes (MDS), a group of cancers in which immature blood cells in the bone marrow do not mature and therefore do not become healthy blood cells. According to IQVIA February 2019 data, the product has sales of $120 million in the US. “This is the third US FDA approval for an oncology product for Wockhardt during the past three months, and has added to our growing portfolio of cancer drugs” said Dr. Habil Khorakiwala, Founder Chairman, Wockhardt Group. “Wockhardt has been sustaining growth in the US and worldwide through an increasing portfolio of specialty products including oncology drugs” he said. Wockhardt will be launching this product in the United States, in a short period of time. With its nationwide distribution network and its excellent relationship with all major trade, retail and institutional customers, Wockhardt is already a significant player in the US pharmaceutical market. The product is being manufactured at a contract manufacturing facility, based near Hyderabad, India. ]]> <![CDATA[Lupin launches Fluoxetine Tablets USP]]> https://biospectrumindia.com/news/95/13333/lupin-launches-fluoxetine-tablets-usp.html https://biospectrumindia.com/news/95/13333/lupin-launches-fluoxetine-tablets-usp.html Wed, 10 Apr 2019 16:35:00 +0530 Lupin Limited (Lupin) announced the launch of Fluoxetine Tablets USP, 60mg, having received an approval from the United States Food and Drug Administration (FDA) earlier. Lupin’s Fluoxetine Tablets USP, 60mg, is the generic version of Alvogen Group Holdings 3 LLC’s Fluoxetine Tablets, 60mg. It is indicated in the treatment of: Major Depressive Disorder (MDD) Adults: Efficacy was established in one 5-week trial, three 6-week trials, and one maintenance study. Pediatrics: Efficacy was established in two 8- to 9-week trials of patients 8 to 18 years of age. Obsessive Compulsive Disorder (OCD) Adults: Efficacy was established in two 13-week trials. Pediatrics: Efficacy was established in one 13-week trial in pediatric patients 7 to 17 years of age. Bulimia Nervosa Adults: Efficacy was established in two 8-week trials and one 16-week trial. Panic disorder, with or without agoraphobia Adults: Efficacy was established in two 12-week trials.   ]]> <![CDATA[Alcon debuts as independent, publicly traded company]]> https://biospectrumindia.com/news/95/13331/alcon-debuts-as-independent-publicly-traded-company.html https://biospectrumindia.com/news/95/13331/alcon-debuts-as-independent-publicly-traded-company.html Wed, 10 Apr 2019 15:20:00 +0530 Alcon, the global leader in eye care dedicated to helping people see brilliantly has announced its debut as an independent, publicly traded company and the completion of its separation from Novartis. The company’s shares begin trading today on the SIX Swiss Exchange and New York Stock Exchange (NYSE) under the symbol “ALC.” Alcon is the largest eye care device company in the world, with complementary businesses in Surgical and Vision Care. The company has a global presence in 74 countries and serves patients in more than 140, with fast-growing businesses in emerging markets. Alcon has the widest array of eye care offerings in the industry with products that can treat eye disorders at each stage of life. “For more than 70 years, Alcon has been dedicated to helping people see brilliantly and now, as an independent company, we are pursuing even more opportunities to further that mission,” said David Endicott, Chief Executive Officer of Alcon. “We are poised to achieve sustainable growth and create long-term shareholder value as a standalone company. We have a long history of industry firsts and, as a nimble medical device company, we are sharply focused on providing innovative products that meet the needs of our customers, patients and consumers.” Eye care is an approximately $23 billion a year market, growing at roughly 4 percent annually. Last year, Alcon had sales of $7.1 billion, including $4.0 billion in Surgical – up 7 percent from the prior year – and $3.1 billion in Vision Care – up 3 percent. Under the terms of the separation, each Novartis shareholder or ADR (American Depositary Receipt) holder will receive one Alcon share for every five Novartis shares or ADRs they held as of the close of business on April 1, 2019, the record date for the distribution. As an independent company, Alcon will have more focus and flexibility in pursuing its own growth strategy driven by rapid iterative innovation. The company will have a distinct investment identity with a more efficient capital structure that will allow it to expand markets, enter promising adjacencies and introduce new business models. These benefits, combined with Alcon’s industry-leading customer relationships, favorably position the company to achieve sustainable growth. Endicott continued: “Demand for eye care is growing significantly as our population ages and people spend more time in front of screens and mobile devices. As we mark this new chapter in the life of our company, all of us at Alcon are committed to addressing the growing consumer need for improved vision and eye health and to expanding access to quality eye care all around the world.” Mr. Sunil Vasanth, General Manager, India, and South East Asia Cluster, Alcon said "With the completion of the spin-off, Alcon will become the largest eye care devices company in the world. As a standalone, publicly-traded company, we intend to use our deep eye care expertise to drive long term sustainable growth, augmented by innovation through R&D to generate tremendous value for our customers.  He added, "We see India as a key growth engine for our business, and we will continue to focus on creating a sustainable, nimble and brilliant business through focused and growth-oriented surgical, vision care and dry eye portfolios. We stand by our commitment of over 2 decades in India, to help Indian patients see brilliantly." Members of the company’s executive leadership team, Board of Directors and Alcon associates celebrated the milestone by ringing the opening bell at the SIX and NYSE on April 9. Alcon is headquartered in Geneva. The company has maintained a presence in Switzerland for more than 40 years and it is where the company was incorporated prior to the Novartis acquisition. Alcon’s facilities in Fort Worth, Texas, will remain a major operational center and innovation hub with a large base of employees. Alcon will continue its substantial Corporate Giving efforts, which in 2018 included $62 million in monetary and product donations. Through its charitable organizations, the Alcon Foundation and Alcon Cares, Alcon partners with hundreds of charitable organizations to help increase access to eye care, providing sight-restoring surgeries, eye exams and other services to people in underserved communities around the world. Alcon also sponsors hands-on and virtual eye care provider training and skills-transfer to strengthen the level of care and supports its communities through charitable donations and associate volunteerism.   ]]> <![CDATA[USFDA approves ViiV Healthcare’s Dovato ]]> https://biospectrumindia.com/news/95/13322/usfda-approves-viiv-healthcares-dovato-.html https://biospectrumindia.com/news/95/13322/usfda-approves-viiv-healthcares-dovato-.html Wed, 10 Apr 2019 10:45:00 +0530 ViiV Healthcare, a global specialist HIV company established in November 2009 by GlaxoSmithKline has announced that the US Food and Drug Administration (FDA) approved Dovato, a complete, once-daily, single-tablet regimen of dolutegravir (DTG) 50 mg and lamivudine (3TC) 300 mg for the treatment of HIV-1 infection in adults with no antiretroviral (ARV) treatment history and with no known resistance to either DTG or 3TC. Dovato, a two-drug regimen (2DR), reduces exposure to the number of ARVs from the start of treatment, while still maintaining the efficacy and high barrier to resistance of a traditional DTG-based three-drug regimen. Deborah Waterhouse, CEO, ViiV Healthcare, said, “Building on our innovative portfolio of medicines, Dovato is powered by dolutegravir, an antiretroviral included in multiple combination therapies and the most prescribed integrase inhibitor in the world, coupled with the established profile of lamivudine. With Dovato, the first complete, single-tablet, two-drug regimen for treatment-naïve adults, ViiV Healthcare is delivering what patients are requesting—a chance to treat their HIV-1 infection with as few drugs as possible, marking a significant step in HIV treatment.” The approval of Dovato is supported by the global GEMINI 1 and 2 studies that included more than 1,400 HIV-1 infected adults. Pedro Cahn, principal investigator for the GEMINI study program said, “People are now living longer with HIV and will spend a lifetime taking drugs to suppress their virus. The approval of the fixed dose combination of dolutegravir and lamivudine, a complete, single-tablet, two-drug regimen, marks a pivotal moment in the treatment of HIV-1. Treatment-naïve people living with the virus have a powerful option that delivers non-inferior efficacy to a dolutegravir-based three-drug regimen, allowing them to take fewer ARVs and get and remain suppressed.” Jeff Berry, Test Positive Aware Network (TPAN), said, “The approval of Dovato is a welcome paradigm shift, as it brings an innovative treatment approach to newly diagnosed adults with HIV-1. By exposing patients to fewer drugs at the start of treatment, the hope is to help address concerns arising from overall management of prolonged ARV therapy.”   DTG/3TC as a complete, once-daily, single-tablet, two-drug regimen for HIV-1 therapy is currently under review by the European Medicines Agency (EMA) and regulatory authorities in Canada, Australia, Switzerland, and South Africa and several additional submissions are planned throughout 2019.     ]]> <![CDATA[Novartis completes spin-off of the Alcon eye care devices business ]]> https://biospectrumindia.com/news/95/13321/novartis-completes-spin-off-of-the-alcon-eye-care-devices-business-.html https://biospectrumindia.com/news/95/13321/novartis-completes-spin-off-of-the-alcon-eye-care-devices-business-.html Wed, 10 Apr 2019 10:35:00 +0530 Novartis has completed the spin-off of the Alcon eye care devices business through a dividend-in-kind distribution to holders of Novartis shares and ADRs (American Depositary Receipts), with each holder receiving one Alcon share for every 5 Novartis shares or ADRs held on April 8, 2019, at the close of business. The successful execution of the Alcon spin-off allows Novartis to fully focus its capital allocation and management attention on medicines. The spin-off gives Novartis a financial profile closer to its pharmaceutical industry peers, including higher group margins. As a focused medicines company, Novartis is well-positioned for sustained top- and bottom-line growth and plans to improve Innovative Medicines core margins into the mid-30s by 2022. Vas Narasimhan, CEO of Novartis, said: "This is an incredibly exciting day for both Novartis and Alcon. Alcon has demonstrated consistent growth, and is coming to market from a position of strength. We wish them the very best for the future. At Novartis, we continue to reimagine ourselves as a leading medicines company powered by breakthrough medicines, data science and advanced therapy platforms. We are well positioned for the future and I am excited for our associates, our investors, and most importantly for patients." As per the company statement, “Novartis has an industry-leading, catalyst-rich pipeline with 10 potential blockbuster launches expected in the next two years and an additional 20 potential blockbusters on the horizon. Of these potential blockbuster launches, four are planned in 2019, including brolucizumab (RTH258). RTH258 is part of the leading ophthalmology pharmaceuticals business retained by Novartis, with 2018 sales of USD 4.6 billion and a pipeline of potential novel treatments for presbyopia, dry eye and genetic diseases.” “Novartis reiterated its disciplined shareholder focused approach to capital allocation, including its intention to continue paying a strong and growing annual dividend up from the CHF 2.85 per share paid in 2019, without adjustments for the Alcon spin-off. Share buybacks will continue to be part of the mix to create shareholder value, with USD 0.8 billion of an up to USD 5 billion commitment completed in 2018, and the remainder expected to be completed by the end of 2019.” Novartis plans to provide more information on its strategic priorities and prospects to investors and analysts at its annual Meet Novartis Management event in Cambridge, Massachusetts, on May 22-23, 2019.     ]]> <![CDATA[ViiV Healthcare’s Dovato gets USFDA nod to treat HIV-1]]> https://biospectrumindia.com/news/95/13313/viiv-healthcares-dovato-gets-usfda-nod-to-treat-hiv-1.html https://biospectrumindia.com/news/95/13313/viiv-healthcares-dovato-gets-usfda-nod-to-treat-hiv-1.html Tue, 09 Apr 2019 13:10:00 +0530 ViiV Healthcare, a subsidiary of GSK announced that the US Food and Drug Administration (FDA) approved Dovato, a complete, once-daily, single-tablet regimen of dolutegravir (DTG) 50 mg and lamivudine (3TC) 300 mg for the treatment of HIV-1 infection in adults with no antiretroviral (ARV) treatment history and with no known resistance to either DTG or 3TC. Dovato, a two-drug regimen (2DR), reduces exposure to the number of ARVs from the start of treatment, while still maintaining the efficacy and high barrier to resistance of a traditional DTG-based three-drug regimen. Deborah Waterhouse, CEO, ViiV Healthcare, said: “Building on our innovative portfolio of medicines, Dovato is powered by dolutegravir, an antiretroviral included in multiple combination therapies and the most prescribed integrase inhibitor in the world, coupled with the established profile of lamivudine. With Dovato, the first complete, single-tablet, two-drug regimen for treatment-naïve adults, ViiV Healthcare is delivering what patients are requesting—a chance to treat their HIV-1 infection with as few drugs as possible, marking a significant step in HIV treatment.” Approval based on GEMINI pivotal trials in which Dovato achieved non-inferior efficacy compared to a dolutegravir-based, traditional, three-drug regimen through 48 weeks, with no cases of resistance. ]]> <![CDATA[Vanta Bioscience signs Rs 29 Cr deal with Emcure Pharma]]> https://biospectrumindia.com/news/95/13310/vanta-bioscience-signs-rs-29-cr-deal-with-emcure-pharma.html https://biospectrumindia.com/news/95/13310/vanta-bioscience-signs-rs-29-cr-deal-with-emcure-pharma.html Tue, 09 Apr 2019 09:00:00 +0530 Vanta Bioscience Limited has announced that its step-down subsidiary ‘Vayam Research Solutions Limited’ has entered into a non-exclusive CRO Service Agreement with Emcure Pharmaceuticals Limited, Pune, for providing services of Bio-Analytical and Bio-Equivalence services to the Company for a period of three years from 2019 to 2022. The development was shared with BSE – the designated Stock Exchange. The CRO Service Agreement provides for a minimum revenue assurance between Rs. 7.00 crores - Rs.9.00 crores for the financial year 2019-2020 and Rs. 20.00 crores for financial year 2020-2021. Speaking on the development, Mr. Dopesh Raja Mulakala, Managing Director, Vanta Bioscience Limited, said, “This deal broadens our horizon. With a steady and assured revenue, we are further encouraged to shorten the timeframe for dominating the category. We now have state-of-the-art facility and world-class expertise to offer services as per global standards. We are confident that we will deliver impeccable results and add continuously value to their business. It is a matter of pride to be associated with an established company like Emcure Pharmaceuticals.” The official spokesperson of Emcure Pharmaceuticals Ltd. added, “Service-efficiency, confidentiality and belief in team in-charge of execution are important factors for selecting the service providers for carrying out our bio-analytical and bio-equivalence studies and we believe that Vayam has the capabilities.” ]]> <![CDATA[Sun Pharma launches ready-to-infuse INFUGEM in the US]]> https://biospectrumindia.com/news/95/13304/sun-pharma-launches-ready-to-infuse-infugem-in-the-us.html https://biospectrumindia.com/news/95/13304/sun-pharma-launches-ready-to-infuse-infugem-in-the-us.html Mon, 08 Apr 2019 14:40:00 +0530 Sun Pharmaceutical Industries Ltd. has announced that INFUGEM™ (gemcitabine in sodium chloride injection), for intravenous use, is now commercially available in the U.S. INFUGEM, the first chemotherapy product that comes in a premixed, ready-to-infuse formulation, was approved by the U.S. Food and Drug Administration (FDA) in July 2018 in combination with other drugs for the treatment of breast, ovarian, non-small cell lung cancers, and as a single agent for the treatment of pancreatic cancer. INFUGEM is an alcohol-free, clear, colorless, sterile solution of 10mg/mL gemcitabine in 0.9% sodium chloride that is supplied to pharmacists in ready-to-infuse bags as a Spike & Go™ package. It involves dose banding practice, whereby standardized doses of intravenous cytotoxic drugs are used for ranges (or “bands”) of doses calculated for individual patients. INFUGEM is the only available gemcitabine formulation that does not require reconstitution and syringe withdrawal prior to intravenous administration. Eliminating these steps reduces complexity and minimizes the inherent risks of hazardous drug exposure, contamination, and medication errors. INFUGEM is the first product using Sun’s proprietary technology which allows cytotoxic oncology products to be premixed in a sterile environment and supplied to the prescribers in ready-to-infuse final dosage bags. The product is stable at room temperature storage conditions for two years, even without the use of alcohol and other preservatives in the bag. By contrast, other gemcitabine products require reconstitution and/or dilution for patient use, and remain stable at room temperature for only 24 hours. ]]> <![CDATA[Lupin Bioresearch Centre completes fifth successful USFDA inspection]]> https://biospectrumindia.com/news/95/13303/lupin-bioresearch-centre-completes-fifth-successful-usfda-inspection.html https://biospectrumindia.com/news/95/13303/lupin-bioresearch-centre-completes-fifth-successful-usfda-inspection.html Mon, 08 Apr 2019 13:15:00 +0530 Lupin has announced the successful completion of the United States Food and Drug Administration (U.S. FDA) inspection at its Lupin Bioresearch Centre (LBC) without any observations. As per the statement, “This is the fifth successive inspection without any 483 observations, indicating superior quality compliance maintained at this global bioresearch facility.” Commenting on the successful inspection, Nilesh Gupta, Managing Director, Lupin expressed satisfaction about the quality management system maintained in LBC and said “Such a high level of compliance reiterates Lupin’s commitment to high-quality standards across its world class research centres.” Lupin Bioresearch Centre (LBC) conducts the in-vivo and in-vitro bioequivalence studies for Lupin in Pune. This inspection also included review of studies done at the center’s new site at Lupin Research Park, Pune.   ]]> <![CDATA[Olon to acquire Mahad plant in India]]> https://biospectrumindia.com/news/95/13312/olon-to-acquire-mahad-plant-in-india.html https://biospectrumindia.com/news/95/13312/olon-to-acquire-mahad-plant-in-india.html Mon, 08 Apr 2019 12:20:00 +0530 OlonS.p.A., a world leading Active Pharmaceutical Ingredients (API) contract development and manufacturing organization (CDMO) and generics supplier has announced the closing of the acquisition of the manufacturing facility in Mahad, India. Paolo Tubertini, CEO of Olon, commented, "With this acquisition Olon achieved another successful milestone toward our growing strategy." Following the acquisition of Ricerca Biosciences' Chemical Division in mid-2017 and Capua BioServices S.p.A. - the global provider of CDMO services in the field microbial fermentation in January 2019 - we have now completed a further step in our strategic plan. With this acquisition, Olon has successfully finalized its 3 years' development plan, we will move to the next target: to play an important role in the manufacturing of biologics API's. The CEO of Olon India Mr Claudio Massari, told: "A new most important journey will start for Mahad site with the new company Olon API India Pvt Ltd. I am looking forward to the future of this company in India as one of Company leader in the API manufacturing not only for the Indian market but for the entire world. Thanks to the excellent facility, strong experienced and talented people, I'm proud to lead Olon India and sure of the long success". After the carve out from Sandoz, as part of the asset purchase agreement, the parties have committed to sign a long-term supply contract to guarantee continuous supply of Sandoz products manufactured in Mahad. The plant's main product is Rifampicin - used to treat several types of bacterial infections, including tuberculosis - and its derivate. Olon intends to invest in the site and pursue business development opportunities to optimize the plant's utilization and expand its customer base. The new company Olon API India Pvt Ltd. has already launched important investment project, establishing a new head office in Mumbai, hiring additional people, improving the organization and Indian market presence and beginning a Technology Transfer introducing new production to the Mahad site. The Mahad site, which supplies products to Sandoz, a division of the Novartis Group,is an established and reputable API manufacturing facility in India with a reaction capacity of 580 m3 and approximately 270 employees. This site provides a number of lifesaving medicines to the Indian healthcare system and patients around the world, with a 2018 turnover equally divided between Indian and foreign markets.  Olon is an Italian company leader in the production of Active Pharmaceutical Ingredients (APIs) via synthesis and biological processes for the generic market and for contract development and manufacturing (CDMO) requirements. Complementary to its activities is the Dossier Unit, whose team of dedicated professionals work on the development of the Finished Drug Formulations (FDFs) and the preparation of the Common Technical Documents (CTD) dossier. Turnover in 2018 of US$ 400 million, with more than 230 APIs (20 under CMO) for the Generic market and 33 chemical intermediates (under CMO). Olon is holder of about 155 active US DMFs and 69 granted CoS. and is able to handle several particular process technologies, such as Fluorination, Carbonylation and Fermentation. With 2000 employees, of which 200 alone are in the specialized R&D team, Olon offers complete integrated packages and services to support  full development of APIs based on strong knowledge in both Chemical and Biological process, all in full cGMPs and with  regulatory coverage. Headquartered in Rodano (Milan, Italy), Olon has 10 manufacturing facilities – 8 located in Italy, 1 in Spain and 1 in USA, all compliant with international requirements, and 3 branch offices in Hamburg (Germany), Florham Park NJ (USA) and Shanghai (China). The manufacturing sites are regularly inspected by the most important national and international Authorities, and regularly audited by our partners and customers. The facilities are FDA-inspected and self-identified under GDUFA. ]]> <![CDATA[Everstone to sell controlling stake in Rubicon Research]]> https://biospectrumindia.com/news/95/13300/everstone-to-sell-controlling-stake-in-rubicon-research.html https://biospectrumindia.com/news/95/13300/everstone-to-sell-controlling-stake-in-rubicon-research.html Mon, 08 Apr 2019 11:35:00 +0530 Everstone is a premier investment group focused on India and South East Asia. Everstone Group’s Singapore fund, will sell its entire stake in Rubicon Research (Rubicon) to a global private equity player, generating 4.5x multiple and a 92% IRR in a span of two and a half years. This would be one of the best returns generated in the pharmaceutical industry. Founded by Pratibha Pilgaonkar, Rubicon is a specialty generics pharmaceutical product development company engaged in research, development and manufacturing of branded and specialty generic products, and OTC products. Everstone’s Singapore fund had acquired a controlling stake in Rubicon and along with co-investor Mankekars, bought out Kotak Private Equity and other shareholders and also invested primary capital in the company. Backed by robust business performance, Rubicon has grown its’ profits by over 5x in a short span of two and a half years, through multiple product approval and launches. Led by Dr Arjun Oberoi and Puncham Mukim, both Managing Directors and Board Members of Rubicon, the Everstone team worked closely with the promoters on their overall strategy, helping them on molecule identification and scaling their manufacturing network. Everstone, through their global network, also brought in external expertise of David Silver, a US pharma industry veteran, to help the company in market feasibility studies. This is yet another successful exit for Everstone managed funds in the healthcare space after their exit from Global Hospitals – sold to IHH in 2015 generating over 3x returns.  ]]> <![CDATA[Olon completes acquisition of Mahad plant]]> https://biospectrumindia.com/news/95/13297/olon-completes-acquisition-of-mahad-plant.html https://biospectrumindia.com/news/95/13297/olon-completes-acquisition-of-mahad-plant.html Mon, 08 Apr 2019 09:00:00 +0530 OlonS.p.A., a world leading Active Pharmaceutical Ingredients (API) contract development and manufacturing organization (CDMO) and generics supplier, has announced the closing of the acquisition of the manufacturing facility in Mahad, India. After an intensive transition period started on September 4th, Olon India will start definitively all the activities the next April 1st according to the strategy of Olon S.p.A. Paolo Tubertini, CEO of Olon, commented, “With this acquisition Olon achieved another successful milestone toward our growing strategy. Following the acquisition of Ricerca Biosciences’ Chemical Division in mid-2017 and Capua BioServices S.p.A. - the global provider of CDMO services in the field microbial fermentation in January 2019 - we have now completed a further step in our strategic plan. With this acquisition, Olon has successfully finalized its 3 years’ development plan, we will move to the next target: to play an important role in the manufacturing of biologics API’s." After the carve out from Sandoz, as part of the asset purchase agreement, the parties have committed to sign a long-term supply contract to guarantee continuous supply of products manufactured in Mahad. The plant’s main product is Rifampicin - used to treat several types of bacterial infections, including tuberculosis - and its derivate. Olon intends to invest in the site and pursue business development opportunities to optimize the plant’s utilization and expand its customer base. The new company Olon API India Pvt Ltd. has already launched important investment project, establishing a new head office in Mumbai, hiring additional people, improving the organization and Indian market presence and beginning a Technology Transfer introducing new production to the Mahad site. The Mahad site, which supplies products to Sandoz, a division of the Novartis Group,is an established and reputable API manufacturing facility in India with a reaction capacity of 580 m3 and approximately 270 employees. This site provides a number of lifesaving medicines to the Indian healthcare system and patients around the world, with a 2018 turnover equally divided between Indian and foreign markets. ]]> <![CDATA[Syngene International and BIRAC set up CAPS]]> https://biospectrumindia.com/news/95/13294/syngene-international-and-birac-set-up-caps.html https://biospectrumindia.com/news/95/13294/syngene-international-and-birac-set-up-caps.html Fri, 05 Apr 2019 14:20:00 +0530 Syngene International Ltd., a leading global contract research organization, announced the opening of its Centre for Advanced Protein Studies (CAPS) by the Secretary, Department of Biotechnology, Government of India. The Centre has been set up in collaboration with the Biotechnology Industry Research Assistance Council (BIRAC) at Syngene’s campus in Bengaluru and will host a state-of-the-art GLP accredited analytical laboratory. Regulatory approval of complex biological molecules involves extensive and advanced analytics including assessment of physiochemical characteristics, efficacy, immunogenicity (antidrug antibody), contamination, strength and more. All these tests need to be performed in a GLP compliant analytical facility. Availability of appropriate certified facilities at affordable costs is a challenge that the start-ups, SMEs/MMEs and the academia in India, have to often face. CAPS will help address this challenge and will be a big boost in advancing biopharma research and product development in India. Spread across an area of 2000 sq. ft, the Centre will run under the ‘Innovate in India’ program of the National Biopharma Mission, Department of Biotechnology, announced by the Government of India. Speaking on the occasion, Kiran Mazumdar Shaw, Managing Director, Syngene International Ltd. said, “I am extremely excited to see this partnership between Syngene and BIRAC. In the last few years, India’s biotechnology sector has seen tremendous action. India has immense scientific and entrepreneurial talent available in the country which gives it strong potential to emerge as the R&D hub for the global biotechnology industry. The CAPS facility will provide the right ecosystem for this talent to pursue their research objectives.” Jonathan Hunt, Chief Executive Officer, Syngene International Ltd., said, “It is indeed an honour for Syngene to collaborate with BIRAC in setting up the CAPS facility. As India’s largest scientific services provider, this collaboration will help Syngene play an active role in the development of India's biotechnology industry as well as nurture the innovative spirit within the industry.” Apart from providing the necessary infrastructure support at affordable cost, CAPS will also focus on advancing technical skill development to global standards, by conducting various trainings and workshops involving eminent subject experts. National Biopharma Mission is an industry-academia collaborative mission of the Department of Biotechnology (DBT) and World Bank for accelerating early development of biopharmaceuticals and is being implemented by BIRAC.   ]]> <![CDATA[Syngene, BIRAC set up Centre for Advanced Protein Studies]]> https://biospectrumindia.com/news/95/13293/syngene-birac-set-up-centre-for-advanced-protein-studies.html https://biospectrumindia.com/news/95/13293/syngene-birac-set-up-centre-for-advanced-protein-studies.html Fri, 05 Apr 2019 14:15:00 +0530 Syngene International Ltd., a leading global contract research organization, has announced the opening of its Centre for Advanced Protein Studies (CAPS) by the Secretary, Department of Biotechnology, Government of India. The Centre has been set up in collaboration with the Biotechnology Industry Research Assistance Council (BIRAC) at Syngene’s campus in Bengaluru and will host a state-of-the-art GLP accredited analytical laboratory. Regulatory approval of complex biological molecules involves extensive and advanced analytics including assessment of physiochemical characteristics, efficacy, immunogenicity (antidrug antibody), contamination, strength and more. All these tests need to be performed in a GLP compliant analytical facility. Availability of appropriate certified facilities at affordable costs is a challenge that the start-ups, SMEs/MMEs and the academia in India, have to often face. CAPS will help address this challenge and will be a big boost in advancing biopharma research and product development in India. Spread across an area of 2000 sq. ft, the Centre will run under the ‘Innovate in India’ program of the National Biopharma Mission, Department of Biotechnology, announced by the Government of India. Speaking on the occasion, Kiran Mazumdar Shaw, Managing Director, Syngene International Ltd. said, “I am extremely excited to see this partnership between Syngene and BIRAC. In the last few years, India’s biotechnology sector has seen tremendous action. India has immense scientific and entrepreneurial talent available in the country which gives it strong potential to emerge as the R&D hub for the global biotechnology industry. The CAPS facility will provide the right ecosystem for this talent to pursue their research objectives.” Jonathan Hunt, Chief Executive Officer, Syngene International Ltd., said, “It is indeed an honour for Syngene to collaborate with BIRAC in setting up the CAPS facility. As India’s largest scientific services provider, this collaboration will help Syngene play an active role in the development of India's biotechnology industry as well as nurture the innovative spirit within the industry.” Apart from providing the necessary infrastructure support at affordable cost, CAPS will also focus on advancing technical skill development to global standards, by conducting various trainings and workshops involving eminent subject experts. National Biopharma Mission is an industry-academia collaborative mission of the Department of Biotechnology (DBT) and World Bank for accelerating early development of biopharmaceuticals and is being implemented by BIRAC. ]]> <![CDATA[Emcure launches world’s first generic Eribulin for treatment of metastatic breast cancer]]> https://biospectrumindia.com/news/95/13272/emcure-launches-worlds-first-generic-eribulin-for-treatment-of-metastatic-breast-cancer.html https://biospectrumindia.com/news/95/13272/emcure-launches-worlds-first-generic-eribulin-for-treatment-of-metastatic-breast-cancer.html Thu, 04 Apr 2019 09:00:00 +0530 Emcure Pharmaceuticals, a leading integrated global pharmaceutical company from India has announced the launch of the world’s first generic version of Eisai Pharmaceutical’s Halaven (Eribulin) for the treatment of metastatic breast cancer (MBC). Emcure will be marketing the drug under brand name ‘Eribilin’, with an aim to offer high-quality and cost-effective treatment option to breast cancer patients in India. As per reports from the Indian Council of Medical Research & Population Based Cancer Registry (ICMR-PBCR) Breast cancer is the commonest occurring cancer in urban Indian women and the second commonest in rural women. Although world class breast cancer treatment is available in India, majority of the patients are unable to access it due to lack of quality infrastructure, skills and above all financial resources. “Incidence of breast cancer is on the rise in India and being a price sensitive market with low awareness, with the launch of Eribilin we aim to provide a proven and cost-effective treatment of high quality and efficacy as offered by the innovator brand. It is a proud moment for Emcure to launch Eribilin, the world’s first generic version of the innovator brand that will break the price barrier making it a cost-effective option for patients,” said Mr. Sainath Iyer, President – Business Strategy & Specialty Business – Emcure Pharmaceuticals Ltd Various Indian studies suggest that about 20% of breast cancers are triple-negative breast cancers. Triple-negative breast cancer (TNBC) is cancer that tests negative for estrogen receptors, progesterone receptors, and excess HER2 protein. It means that the growth of the cancer is not fuelled by the hormones estrogen and progesterone, or by the HER2 protein. Even though chemotherapy may work well for this type of breast cancer, the chance of relapse is high and overall prognosis is poor than the other types of breast cancer. Emcure’s Eribilin has been approved by DCGI to be marketed in India. “Breast cancer is the most common type of cancer affecting women in India and its incidence is on the rise. Currently available treatment for triple negative breast cancer in India is out of reach of most patients due to its high cost. Emcure’s Eribilin will change this scenario by offering a world-class, high quality drug at a reasonable price to the patients in India” said Mr. Sainath Iyer, President – Business Strategy & Specialty Business – Emcure Pharmaceuticals Ltd. Eribulin is a non-taxane inhibitor of microtubule dynamics and remains effective in MBC previously treated with an anthracycline and a taxane. Eribulin is a complex API derived from a marine natural product called Halocondrin B. “Emcure’s R&D resources are equipped with technical competence and state-of-the-art development facility to develop such complex generics. Generic Eribulin is a landmark achievement of Emcure’s R&D efforts both in API manufacturing and formulation,” said Dr. Mukund Gurjar, Chief Scientific Officer, Emcure Pharmaceuticals. Emcure will manufacture generic Eribulin at its state of the art plant at Hinjewadi in Pune and market it at a cost which will be approximately 40% less than the innovator brand bringing hope to millions of breast cancer patients in India. The drug would currently be marketed in India, however Emcure plans to register the brand in international markets as well, wherever the drug is about to go off-patent. Eribilin is world’s first generic version of Eisai Pharmaceutical’s Halaven (Eribulin) for the treatment of metastatic breast cancer (MBC). Eribulin is a mechanistically unique inhibitor of microtubule dynamics and binds predominantly to a small number of high affinity sites through both cytotoxic and non-cytotoxic mechanisms. It eliminates cancer cells through prolonged and irreversible mitotic blockade. The parent molecule is a potent, naturally occurring mitotic inhibitor found in the sponge genus Halichondria. ERIBILIN has been developed indigenously by Emcure Pharmaceuticals and offers the same quality and efficacy as the original brand. ERIBILIN will be manufactured in Emcure’s plant at Hinjewadi, Pune. Emcure Pharmaceuticals Ltd. is a leading vertically integrated global pharmaceutical company from India focusing on R&D, marketing and manufacturing of acute and chronic therapy range of products. It is ranked among the top 10 pharmaceutical companies in India and is the leading provider of oncology, nephrology, antiretroviral, gynaecology, cardiac, anti-malarial and anti-infective therapies. Globally it is present in 70 countries with 15 subsidiaries and 7 representative offices. Its range of products for the treatment of breast cancer includes Taxotere (docetaxel), Palcitaxel, Fulvestrant, Letrozole and Lapatinib. ]]> <![CDATA[Himedia wins Pride of Maharashtra award]]> https://biospectrumindia.com/news/95/13273/himedia-wins-pride-of-maharashtra-award.html https://biospectrumindia.com/news/95/13273/himedia-wins-pride-of-maharashtra-award.html Wed, 03 Apr 2019 15:45:00 +0530 Maharashtra Industrial and Economic Development Association (MIEDA) which represents members from manufacturing and service sector Industries, recently honored HiMedia Laboratories Pvt Ltd with the prestigious “Pride of Maharashtra Award” under the category of “Best Company of The Year Award”. HiMedia received the unique recognition for translating research into biotech products applications for scientists and innovators. HiMedia is an established company with professionals and technologists for manufacturing high quality culture media for microbiology, has over the years created a rich portfolio of exemplar quality products. Today it is a leading biosciences organisation with strong research based products portfolio in various areas of bioscience. The company has its global presence in more than 150 countries and is amongst the top three brands in microbiology in the world. The HiMedia Laboratories Pvt Ltd is spearheaded by the Warke Family since 1973. It was founded by Dr. Gangadhar Motiram Warke (Chairman & Managing Director), co-founded by Dr. G.M. Warke’s spouse Mrs. Saroj Warke (Co-founder and Director-IT) and younger brother Mr. Vishnu M. Warke (Co-founder and Director-Marketing). The technical directors of the next generation, Dr. Vishal G. Warke (Director- Cell culture & Immunology and higronics), Dr.Rahul G. Warke (Director – Microbiology), Dr.Priti V. Warke (Director-Cell culture & Immunology and higronics), Dr. Rajas V. Warke (Director- Molecular Biology andVirology) and Dr.Kavita Khadke (Associate Director-Molecular biology and Virology). The innovation and strong capabilities of Dr.G.M. Warke in translating research into biotech products applications for scientists and innovators are appreciated and recognised by MIEDA. Towards this MIEDA further honored Dr.G.M.Warke for special felicitation by presenting “Brand Ambassador of Maharashtra in Research &amp; Innovation category”.The awards and conference was presented and addressed by Padma Vibhushan Dr. Raghunath Mashelkar- President, Global Research Alliance & Former Director General of Council of Scientific & Industrial Research (CSIR), Shri Subhash Desai-Hon’ble Minister for Industry and Dr. Lalit Kanodia, CMD, Datamatics Group of Companies. The ceremony was held during the inaugural of the 5th Edition of “Maharashtra Economic Summit” and 25th Foundation Day Function of MIEDA at MCA, BKC, Mumbai with support of Government of Maharashtra and in association with SME Chamber of India. ]]> <![CDATA[Lupin launches Tadalafil Tablets USP]]> https://biospectrumindia.com/news/95/13256/lupin-launches-tadalafil-tablets-usp.html https://biospectrumindia.com/news/95/13256/lupin-launches-tadalafil-tablets-usp.html Tue, 02 Apr 2019 14:10:00 +0530 Lupin has announced the launch of Tadalafil Tablets USP, 2.5 mg, 5 mg, 10 mg, and 20 mg, having received an approval from the United States Food and Drug Administration (FDA) earlier. Lupin’s Tadalafil Tablets USP, 2.5 mg, 5 mg, 10 mg, and 20 mg, is the generic equivalent of Eli Lilly and Company’s Cialis Tablets, 2.5 mg, 5 mg, 10 mg, and 20 mg. It is indicated for the treatment of: erectile dysfunction (ED) the signs and symptoms of benign prostatic hyperplasia (BPH) ED and the signs and symptoms of BPH (ED/BPH) Tadalafil Tablets USP, 2.5 mg, 5 mg, 10 mg, and 20 mg (RLD: Cialis) had annual sales of approximately USD 1780 million in the US (IQVIA MAT December 2018). ]]> <![CDATA[Lupin’s Pithampur Unit-3 (Indore) receives EIR from USFDA]]> https://biospectrumindia.com/news/95/13255/lupins-pithampur-unit-3-indore-receives-eir-from-usfda.html https://biospectrumindia.com/news/95/13255/lupins-pithampur-unit-3-indore-receives-eir-from-usfda.html Tue, 02 Apr 2019 14:05:00 +0530 Lupin has announced the receipt of the Establishment Inspection Report (EIR) for its Pithampur (Unit-3) facility. The inspection was conducted between October 8, 2018 to October 18, 2018. Commenting on the development, Nilesh Gupta, Managing Director, Lupin said, “Receiving the EIR for our Pithampur Unit-3 facility is a very positive development and brings us one step closer to bringing important MDIs and DPIs to the market. We are committed to ensuring the quality, safety and efficacy of the products that we manufacture across our facilities.” Lupin’s Pithampur Unit-3 is involved in the manufacture of Metered Dose Inhalers (MDIs), Dry Powder Inhalers (DPIs) and Topical Formulations for the regulated markets.   ]]> <![CDATA[Dr. Reddy’s announces US rights for its dermatology brands ]]> https://biospectrumindia.com/news/95/13249/dr-reddys-announces-us-rights-for-its-dermatology-brands-.html https://biospectrumindia.com/news/95/13249/dr-reddys-announces-us-rights-for-its-dermatology-brands-.html Tue, 02 Apr 2019 11:50:00 +0530 Dr. Reddy’s Laboratories Limited, through its wholly owned subsidiary Promius Pharma, LLC, announces the sale of its rights for SERNIVO® (betamethasone dipropionate) Spray, 0.05% and assignment of its rights to market and distribute, PROMISEB®Topical Cream and TRIANEX® 0.05% (Triamcinolone Acetonide Ointment, USP) in the United States, to Encore Dermatology. Under the terms of the agreement, Promius Pharma is eligible to receive an upfront payment and future milestone payments contingent upon achievement of certain commercial objectives. “This is in line with our renewed strategy to enable us achieve self-sustainability and profitable growth for each of our businesses,” said G.V. Prasad, Co-Chairman and CEO, Dr. Reddy’s. “We are confident in Encore’s ability to realize the full potential of the enlisted products. We look forward to working with Encore to ensure a smooth transition of these brands and to ensure they are able to quickly deliver these products to providers and patients.” says Anil Namboodiripad, Ph.D., Senior Vice President, Proprietary Products, and President, Promius Pharma. ]]> <![CDATA[Pulmatrix signs binding agreement with Cipla worth $22M]]> https://biospectrumindia.com/news/95/13247/pulmatrix-signs-binding-agreement-with-cipla-worth-22m.html https://biospectrumindia.com/news/95/13247/pulmatrix-signs-binding-agreement-with-cipla-worth-22m.html Tue, 02 Apr 2019 10:50:00 +0530 Pulmatrix, Inc., a clinical stage biopharmaceutical company focused on developing novel inhaled therapeutics to serve unmet needs in respiratory disease, has announced its entry into a Binding Term Sheet with Cipla Technologies LLC, a subsidiary of Cipla Limited for the co-development and commercialization of Pulmazole (PUR1900) – an inhaled iSPERSE™ formulation of the anti-fungal drug itraconazole for the treatment of allergic bronchopulmonary aspergillosis (ABPA) in patients with asthma. As per the Binding Term Sheet, subject to entry into the definitive agreement, Cip Tec will make an upfront payment of $22 million to Pulmatrix in exchange for an assignment of all rights to Pulmazole to Cip Tec. However, following this assigning, Pulmatrix will retain the right to receive 50% of the free cash flow from future sales of Pulmazole. In addition, Pulmatrix will remain primarily responsible for the implementation of the clinical development of Pulmazole and Cip Tec will be responsible for implementation of the commercialization of the product. Entry into a definitive agreement is contingent upon, Pulmatrix having at least $15 million in unencumbered funds. ABPA is a disease that occurs most often in patients with underlying asthma or cystic fibrosis, and it is characterized by an exaggerated allergic hypersensitivity response of the immune system to the fungus Aspergillus colonizing and growing in the airways. Oral itraconazole (Sporanox®) is currently used as an adjunctive treatment to corticosteroids in ABPA patients. However, its use is limited by poor bioavailability, variable pharmacokinetics, and toxicity concerns related primarily to the risk of gastrointestinal and cardiac side effects, as well as extensive drug-drug interactions. Pulmatrix Pulmazole program is the first inhaled dry powder version of itraconazole known to the company to be advanced into clinical development, with the goal of improving upon the known safety and efficacy profile associated with oral Sporanox by delivering the drug directly to the lung. ]]> <![CDATA[Jubilant Biosys adds advanced Pioneer FE system to its platform of drug discovery solutions]]> https://biospectrumindia.com/news/95/13238/jubilant-biosys-adds-advanced-pioneer-fe-system-to-its-platform-of-drug-discovery-solutions.html https://biospectrumindia.com/news/95/13238/jubilant-biosys-adds-advanced-pioneer-fe-system-to-its-platform-of-drug-discovery-solutions.html Mon, 01 Apr 2019 14:25:00 +0530 Jubilant Biosys, a subsidiary of Jubilant Life Sciences Ltd has announced that it has added advanced Pioneer FE system to its platform of drug discovery solutions available to customers. The Pioneer FE system from ForteBio, the Biologics Business Unit of Molecular Devices, represents the next generation SPR instrumentation for label-free characterization of biomolecules. The Pioneer system uses a unique OneStep gradient injection technology to facilitate fragment screening and is also sensitive enough to measure high affinity and covalent binding events. Pioneer systems with OneStep technology can analyze up to 768 fragments in 24 hours, obtaining kinetics during the primary screen and eliminating the need for additional screens. The Pioneer system is the first placed in India, and part of Jubilant's continuing investment in new technologies supporting their innovator customers' needs. Commenting on the development, Marcel Velterop, President, Jubilant Biosys, "The addition of the Pioneer SPR system will significantly upgrade and speed-up our small molecule-hit finding engine for novel target classes." Greg Milosevich, President of Molecular Devices, commented, "We are pleased to have Jubilant adopt the Pioneer platform and look forward to supporting them and their customers' goals in fast-tracking small molecule drug discovery programs." Jubilant Biosys, a subsidiary of Jubilant Life Sciences Ltd., an integrated global pharmaceutical and life sciences company, has presence in Bengaluru and Noida in India. Jubilant Biosys has demonstrated expertise across multiple therapeutic areas including but not limited to Oncology, Metabolic Disorders, Pain & Inflammation and CNS. Business models include both functional and integrated discovery services upto IND including GLP and GMP services, proprietary in-house innovation and strategic investments as the core components which are available for collaborative research, partnership and out-licensing. ]]> <![CDATA[Novartis to acquire IFM Tre in a $310M deal]]> https://biospectrumindia.com/news/95/13235/novartis-to-acquire-ifm-tre-in-a-310m-deal.html https://biospectrumindia.com/news/95/13235/novartis-to-acquire-ifm-tre-in-a-310m-deal.html Mon, 01 Apr 2019 11:45:00 +0530 IFM Therapeutics (IFM), a privately held biopharmaceutical company focused on developing therapies that modulate novel targets in the innate immune system, announced that it has reached a definitive agreement with Novartis, under which Novartis will acquire all of the outstanding capital stock of IFM Tre, a subsidiary company of IFM. Upon the closing of the agreement, IFM will receive $310 million in upfront payments and will be eligible for up to $1.265 billion in milestone payments, for a total of $1.575 billion in total consideration. IFM Tre launched in July 2018, with a focus on developing a suite of NLRP3 antagonists for the treatment of inflammatory diseases. The acquisition will give Novartis full rights to IFM Tre's portfolio of NLPR3 antagonists, which consists of one clinical and two pre-clinical programs: IFM-2427, a first-in-class, clinical stage systemic antagonist for an array of chronic inflammatory disorders including atherosclerosis and nonalcoholic steatohepatitis (NASH); a pre-clinical stage gut-directed molecule for the treatment of inflammatory bowel disease; and a pre-clinical stage central nervous system (CNS)-penetrant molecule.  NLRP3 (NOD-, LRR- and pyrin domain-containing 3) is an intracellular innate immune signaling receptor that allows immune cells to detect the presence of pro-inflammatory foreign or endogenous molecules that signal infection, tissue damage or metabolic derangements. These conditions trigger the assembly of a multi-protein complex called an inflammasome, which then initiates an immune response. While this response can be useful for fending off foreign pathogens, abnormal or chronic activation of the NLRP3 inflammasome is known to cause negative downstream effects and the onset and progression of numerous diseases.   IFM Tre's programs target the innate immune system by suppressing only the inflammation mediated by the NLRP3 pathway, leaving other immune pathways unsuppressed and free to produce inflammatory responses to confront harmful pathogens. The transaction has been approved by the board of directors and stockholders of IFM. IFM and Novartis anticipate the transaction will close during the second quarter of 2019. Closing of the transaction is subject to customary closing conditions, including clearance under the Hart-Scott-Rodino Antitrust Improvements Act. ]]> <![CDATA[Zydus gets USFDA nod to treat pulmonary arterial hypertension]]> https://biospectrumindia.com/news/95/13229/zydus-gets-usfda-nod-to-treat-pulmonary-arterial-hypertension.html https://biospectrumindia.com/news/95/13229/zydus-gets-usfda-nod-to-treat-pulmonary-arterial-hypertension.html Fri, 29 Mar 2019 14:00:00 +0530 Zydus Cadila is an innovative, global pharmaceutical company that discovers, develops, manufactures and markets a broad range of healthcare therapies The company has received the final approval from the USFDA to market Ambrisentan Tablets USP (US RLD – Letairis Tablets), 5 mg and 10 mg. It is used to treat high blood pressure in the lungs (pulmonary arterial hypertension) and will be manufactured at the group’s formulations manufacturing facility at SEZ, Ahmedabad. The US sales of Ambrisentan Tablets USP stood at $ 943 million in 2018. The group now has 258 approvals and has so far filed over 350 ANDAs since the commencement of the filing process in FY 2003-04. ]]> <![CDATA[Lupin launches Fluocinonide Ointment USP 0.05%]]> https://biospectrumindia.com/news/95/13227/lupin-launches-fluocinonide-ointment-usp-0-05.html https://biospectrumindia.com/news/95/13227/lupin-launches-fluocinonide-ointment-usp-0-05.html Fri, 29 Mar 2019 12:45:00 +0530 Lupin announced the launch of Fluocinonide Ointment USP, 0.05%, having received an approval from the United States Food and Drug Administration (FDA) earlier. Lupin’s Fluocinonide Ointment USP, 0.05%, is the generic version of County Line Pharmaceuticals LLC’s Lidex® Ointment 0.05%. It is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Fluocinonide Ointment USP, 0.05% had annual sales of approximately USD 15 million in the U.S (IQVIA MAT January 2019). ]]> <![CDATA[Indian Pharma Sector: What Next After Gottlieb?]]> https://biospectrumindia.com/news/95/13225/indian-pharma-sector-what-next-after-gottlieb.html https://biospectrumindia.com/news/95/13225/indian-pharma-sector-what-next-after-gottlieb.html Fri, 29 Mar 2019 12:00:00 +0530 Indian drug makers, whose major part of business comes from the sale of generics in the US, received all the encouragement needed when the US Food and Drug Administration (USFDA) Commissioner Dr. Scott Gottlieb came out in support of generics manufactured in India. Under Gottlieb, the USFDA in 2017 permitted a record 844 generic drugs, a 36 percent rise compared to previous year. Indian companies alone accounted for 42 percent of all those approvals. In 2018, the regulatory body approved 810 generic drugs, out of which India's share was a substantial 40 percent. Gottlieb also made efforts to bring low-cost generic versions of complex drugs such as inhalation drugs, transdermal patches, injectables and biosimilars faster to the market, which have long avoided competition. Complex generics are drugs that are harder to copy under traditional approaches. As a result, these drugs often face less competition and are more expensive. However, the recent exit of Gottlieb from the agency has set in a mood of anxiety for the Indian pharma industry. But whether the steps taken by Gottlieb in favour of the pharma companies in India goes back to square one, is something that needs to be watched. Currently, the U.S. President Donald Trump’s administration has tapped National Cancer Institute Director Norman Sharpless to serve as the acting commissioner for the Food and Drug Administration.   BioSpectrum interacted with few industry experts to find out about their views on this development-   “USFDA is a process driven organisation. It has always been very fair and objective in its approach towards industry and in ensuring compliance. Over time we have seen its processes evolve, help the industry raise the bar and it has always been sharply focused on patients. We are sure the USFDA will continue to serve patients and help the industry go to the next level.” Prashant Sharma, President, Group Manufacturing & Operations, Zydus Cadila   “The faster pace of ANDA approvals was initially triggered by the GDUFA Act in 2012.  Enhancing level of competition in generic drugs has been a continued agenda of the US Government as a means to reduce overall healthcare cost.  The most recent budget document from the Trump Administration emphasizes the intent emphatically.  Hence, I don’t anticipate a significant impact of Commissioner Gottileb’s resignation.  While I don’t perceive this as a challenge for industry, I would like to emphasize that faster approvals and a more generics friendly environment has also been the largest bane for industry.  The level of price erosion that industry is shuddering under is also a consequence of more intense competition – a new world where more than 10 companies sharing Para IV exclusivity or stand in line with tentative approvals more than 12 months before the market actually opens.  While I don’t expect the pace of regulatory support to change, the new normal of commercial reality may not change as well.”  Pushpa Vijayaraghavan, Director & Practice Lead – Healthcare, Sathguru Management Consultants   “Scott Gottlieb resignation from USFDA comes a shock to both industry and patients alike. He advocated improved patient care and was instrumental in promoting innovative solutions for addressing most pressing health challenges. He advocated that regulations should foster improved healthcare and not impede innovation. His unique background as physician with venture capital experience made him extremely empathetic in understanding the needs of the patients and as well as revenue driven healthcare industry. During his tenure he initiated the generic drug user fee program and record number of generic drugs and novel medical devices approval. Under his regime, FDA made efforts to reorganize the approval pathways, including the De Novo and 510(k) processes for medical devices approvals.” Nita Sachan, Head Strategy, Medical Technology and Healthcare (MT&H), Cyient ]]> <![CDATA[Jubilant Biosys adopts ForteBio's latest SPR System in India]]> https://biospectrumindia.com/news/95/13218/jubilant-biosys-adopts-fortebios-latest-spr-system-in-india.html https://biospectrumindia.com/news/95/13218/jubilant-biosys-adopts-fortebios-latest-spr-system-in-india.html Thu, 28 Mar 2019 16:35:00 +0530 Jubilant Biosys, a subsidiary of Jubilant Life Sciences Ltd has added advanced Pioneer FE system to its platform of drug discovery solutions available to customers. The Pioneer FE system from ForteBio, the Biologics Business Unit of Molecular Devices, represents the next generation SPR instrumentation for label-free characterization of biomolecules.  The Pioneer system uses a unique OneStep® gradient injection technology to facilitate fragment screening and is also sensitive enough to measure high affinity and covalent binding events. Pioneer systems with OneStep® technology can analyze up to 768 fragments in 24 hours, obtaining kinetics during the primary screen and eliminating the need for additional screens. The Pioneer system is the first placed in India, and part of Jubilant's continuing investment in new technologies supporting their innovator customers' needs. Commenting on the development, Marcel Velterop, President, Jubilant Biosys, "The addition of the Pioneer SPR system will significantly upgrade and speed-up our small molecule-hit finding engine for novel target classes." ]]> <![CDATA[1mg Technologies gets ISO 27001 certification]]> https://biospectrumindia.com/news/95/13209/1mg-technologies-gets-iso-27001-certification.html https://biospectrumindia.com/news/95/13209/1mg-technologies-gets-iso-27001-certification.html Thu, 28 Mar 2019 11:50:00 +0530 There has been a huge information imbalance in the field of medicine and 1mg.com has been working towards providing reliable and authentic medicine related information to the consumers for close to five years. 1mg.com has received the ISO 27001 certification for compliance with the international standards, making it one of the pioneers in the Indian healthcare industry to achieve this major certification. This certification will further enhance the focus of the company towards process of continuous improvement and innovation. ISO/IEC 27001:2013, also known as 'Information Security Management Systems (ISMS)', is an independent voluntary certification which lays out implementation and management guidelines to safeguard digital information such as financial data, intellectual property or sensitive customer information. This robust framework also helps in identifying risks and puts in place security measures that are right for businesses, so that they can manage their information prudently. It helps in continuous review and refinement of the process. Having ISO 27001 certification ensures that an organization has implemented the required legal, statutory, regulatory and quality standards to protect all sensitive information against unauthorized access. 1mg.com has made its mark across India for being a pioneer in providing integrated healthcare services through digital platform. 1mg.com is one of India's leading digital consumer healthcare platform providing access to allopathic, ayurvedic, homeopathic, health supplements and other health-related products at consumers' doorstep across Indiafrom licensed and verified pharmacies. 1mg.com also provides e-diagnostic with free home sample collection and e-consultation services through its integrated healthcare platform. 1mg.com has strived to make health care accessible to millions by giving them quality care at affordable prices. Gaurav Agarwal, CTO and Co-founder, 1mg Technologies shared this accomplishment and said, "At 1mg we've always given patient safety and privacy utmost importance. ISO 27001 certification, gold standard in information security, is a timely validation of our values - safeguarding patient's healthcare and privacy information at all levels and with the best available technology and tools. We remain committed to ensuring that best practices in information security management are complied by 1mg in order to strengthen the trust placed by the consumer on us."   ]]> <![CDATA[Madras High Court upholds Kibow Biotech’s Indian patent for Renadyl]]> https://biospectrumindia.com/news/95/13204/madras-high-court-upholds-kibow-biotechs-indian-patent-for-renadyl.html https://biospectrumindia.com/news/95/13204/madras-high-court-upholds-kibow-biotechs-indian-patent-for-renadyl.html Wed, 27 Mar 2019 16:50:00 +0530 In a major victory for global patent standards and for efforts to offer Indian consumers top international healthcare options, Kibow Biotech Inc, USA was awarded a huge win on its Indian patent by the Madras High Court last week. The Philadelphia-based biotech firm’s Indian patent for Renadyl™, its flagship kidney health supplement, was granted in September 2008, but later challenged by La Renon, an Ahmedabad-based company which marketed a similar product. In a well- reasoned decision, India’s specialized intellectual property tribunal, IPAB denied La Renon’s challenge and upheld Kibow’s patent in 2013. La Renon then sought a review of this ruling before the Madras high court, which effectively agreed with the IPAB and once again upheld Kibow’s patent [Patent No. 351/MUMNP/2006, 224100 “Compositions for Augmenting Kidney Function” Patent No. 224100]. Kibow Biotech Inc has also obtained the same patent (and several more, totaling 35 patents thus far) in Australia, Canada, China, Japan, South Korea, the European Union and USA. Dr. Natarajan Ranganathan, KIBOW’s founder and chief architect, hailed the ruling as a huge victory for innovation and “the long years of intensive research and development” that went into developing Kibow’s unique “Enteric Dialysis” platform TECHNOLOGY that forms the basis for Renadyl™. This special probiotic dietary supplement uses the bowel and the gut microbiome to assist ailing kidneys in metabolizing uremic toxins like urea, creatinine, uric acid and several cardiovascular toxins and thus potentially delay the need for Hemo- Dialysis and Peritoneal Dialysis in many patients. "Renadyl™ is a product backed by two decades of wide-ranging international research, extensive pharma like validation including three human clinical trials and the endorsement of some of the world’s leading nephrologists for its, safety, efficacy and improving quality of life for many patients,” says Dr. Ranganathan, while also pointing to the global health community’s increasing realization of the vital role the gut microbiome plays in many of our health processes. “Given their easy availability and innocuous nature, the use of well researched and highly strain specific probiotics to modulate an unhealthy gut microbiome in CKD patients is a very promising intervention and helps preserve renal function,” he added. Kibow’s Indian partner Centaur Pharmaceuticals also applauded the ruling. The Mumbai-based company Centaur Pharmaceuticals has the exclusive rights for importing, packaging, marketing, distribution and sale of Renadyl™ throughout India. Centaur Pharmaceuticals are also planning to import the identical specific probiotic strains/ingredients and manufacture the product in their US FDA approved facilities in Pune by the end of this year. ]]> <![CDATA[Lupin receives FDA approval for Tadalafil Tablets USP]]> https://biospectrumindia.com/news/95/13202/lupin-receives-fda-approval-for-tadalafil-tablets-usp.html https://biospectrumindia.com/news/95/13202/lupin-receives-fda-approval-for-tadalafil-tablets-usp.html Wed, 27 Mar 2019 15:55:00 +0530 Pharma major Lupin Limited (Lupin) announced that it has received approval for its Tadalafil Tablets USP, 2.5 mg, 5 mg, 10 mg, and 20 mg, from the United States Food and Drug Administration (FDA) to market a generic version of Eli Lilly and Company’s Cialis Tablets, 2.5 mg, 5 mg, 10 mg, and 20 mg. Lupin’s Tadalafil Tablets USP, 2.5 mg, 5 mg, 10 mg, and 20 mg, is the generic equivalent of Eli Lilly and Company’s Cialis Tablets, 2.5 mg, 5 mg, 10 mg, and 20 mg. It is indicated for the treatment of: •Erectile dysfunction (ED) •The signs and symptoms of benign prostatic hyperplasia (BPH) •ED and the signs and symptoms of BPH (ED/BPH) Tadalafil Tablets USP, 2.5 mg, 5 mg, 10 mg, and 20 mg (RLD: Cialis) had annual sales of approximately USD 1780 million in the US (IQVIA MAT December 2018). Lupin is an innovation led transnational pharmaceutical company developing and delivering a wide range of branded &generic formulations, biotechnology products and APIs globally. The Company is a significant player in the Cardiovascular, Diabetology, Asthma, Pediatric, CNS, GI, Anti-Infective and NSAID space and holds global leadership position in the Anti-TB segment.   ]]> <![CDATA[Lupin's Pune Biotech facility receives EU GMP clearance]]> https://biospectrumindia.com/news/95/13201/lupins-pune-biotech-facility-receives-eu-gmp-clearance.html https://biospectrumindia.com/news/95/13201/lupins-pune-biotech-facility-receives-eu-gmp-clearance.html Wed, 27 Mar 2019 15:25:00 +0530 Pharma major Lupin Limited has announced that it has received the ‘European Good Manufacturing Practice’ (EU GMP) certificate for its Mammalian Facility in Pune where Etanercept Biosimilar is intended to be manufactured. This GMP certification further confirms that Lupin has a robust manufacturing facility that ensures consistent and controlled production as per EU quality standards. Commenting on this development, Mr. Nilesh Gupta, Managing Director, Lupin Limited stated, “Etanercept is a complex product that requires a sophisticated development facility for production. The EU GMP certificate is a noteworthy achievement by the Biotech manufacturing team. With this timely approval of our biotech facility we are well on track to start preparing for the manufacture and launch of our Etanercept Biosimilar for Europe. This will enable us to offer a high-quality option that helps reducing healthcare expenses”. “Etanercept is used globally in the fight against a range of severe autoimmune disorders. The successful approval of the facility is testament to our quality and compliance standards and is a major step in achieving our goal for market entry in to Europe post approval of the product,” said Dr. Cyrus Karkaria, President, Lupin Biotech. “After significant investment in our biotechnology R&D division over the years, this is the first biosimilar for regulated markets developed and manufactured in-house at Lupin. It is an important achievement for us and sets the tone for future biosimilar development.” Lupin is an innovation led transnational pharmaceutical company developing and delivering a wide range of branded & generic formulations, biotechnology products and APIs globally. The Company is a significant player in the Cardiovascular, Diabetology, Asthma, Pediatric, CNS, GI, Anti-Infective and NSAID space and holds global leadership position in the Anti-TB segment. ]]> <![CDATA[Novartis’ Mayzent gets FDA nod to treat multiple sclerosis]]> https://biospectrumindia.com/news/95/13199/novartis-mayzent-gets-fda-nod-to-treat-multiple-sclerosis.html https://biospectrumindia.com/news/95/13199/novartis-mayzent-gets-fda-nod-to-treat-multiple-sclerosis.html Wed, 27 Mar 2019 12:15:00 +0530 Novartis has received the US Food and Drug Administration (FDA) approval of Mayzent® (siponimod) for the treatment of adults with relapsing forms of multiple sclerosis, including secondary progressive multiple sclerosis (SPMS) with active disease, relapsing remitting multiple sclerosis (RRMS) and clinically isolated syndrome (CIS). SPMS is a debilitating form of multiple sclerosis (MS) characterized by progressive and irreversible neurological disability. Mayzent is expected to be available in the US in approximately one week. Patients will not require a first dose observation (FDO, cardiac monitoring upon initiation) unless they have certain pre-existing cardiac conditions. "One of the most important aims of MS treatment is delaying disability progression and preserving cognition," said Paul Hudson, Chief Executive Officer, Novartis Pharmaceuticals. "With Mayzent, SPMS patients with active disease will have access to the first effective oral therapy directed towards disease progression, even when MS transitions to a stage where deterioration is less dependent on the usual relapse activity. Mayzent is a testament to the Novartis mission to reimagine medicine. We are delighted that our ongoing commitment to stop MS has led to a much awaited treatment for these patients in need." This approval will stimulate a conversation between patients and healthcare professionals about disability progression after relapsing remitting MS and its early management." Approval is based on the Phase III EXPAND trial, the largest controlled clinical study of SPMS patients, showing Mayzent significantly reduced the risk of disease progression, including impact on physical disability and cognitive decline. Novartis is committed to bringing Mayzent to patients worldwide, and additional regulatory filings are currently underway with other health authorities outside the US. Regulatory action for Mayzent in the European Union is anticipated in late 2019, with additional regulatory action anticipated in Switzerland, Japan, Australia and Canada this year. ]]> <![CDATA[Novartis plans for Alcon spin-off on April 9, 2019]]> https://biospectrumindia.com/news/95/13197/novartis-plans-for-alcon-spin-off-on-april-9-2019.html https://biospectrumindia.com/news/95/13197/novartis-plans-for-alcon-spin-off-on-april-9-2019.html Wed, 27 Mar 2019 11:50:00 +0530 Novartis confirmed that certain important conditions precedent for the 100% spin-off of the Alcon eye care business have been met, including receipt of certain necessary authorizations and rulings. Completion of the transaction, by way of a distribution of a dividend in kind to Novartis shareholders and ADR (American Depositary Receipt) holders, is expected to be on April 9, 2019.In the distribution, each Novartis shareholder will receive 1 Alcon share for every 5 Novartis shares/ADRs they hold on April 8, 2019, close of business. Approval has been given, subject to customary conditions, by the SIX Exchange Regulation for the listing of the shares of Alcon Inc. on the SIX Swiss Exchange (SIX) pursuant to the International Reporting Standard. Authorization has also been received for the listing of shares in Alcon Inc. on the New York Stock Exchange (NYSE).  Alcon will seek effectiveness of the Alcon Inc. Form 20-F registration statement from the US Securities and Exchange Commission (SEC). Shares in Alcon Inc. are expected to be listed and traded from April 9, 2019 on the SIX and the NYSE under the ticker symbol "ALC". Alcon will also be included in both the Swiss Market Index (SMI®) and Swiss Performance Index (SPI®) from the first day of trading, as recently announced by the SIX. Alcon has secured debt financing of USD 3.5 billion through a group of banks. The Alcon credit rating will be investment grade following the spin-off. Moody's Investor Service and S&P Global Ratings have rated Alcon at Baa2 and BBB, respectively, with a stable outlook. Bank of America Merrill Lynch and UBS AG are advising Novartis on the transaction. ]]> <![CDATA[Lupin and YL Biologics receives PMDA approval for Etanercept biosimilar in Japan]]> https://biospectrumindia.com/news/95/13186/lupin-and-yl-biologics-receives-pmda-approval-for-etanercept-biosimilar-in-japan.html https://biospectrumindia.com/news/95/13186/lupin-and-yl-biologics-receives-pmda-approval-for-etanercept-biosimilar-in-japan.html Tue, 26 Mar 2019 11:40:00 +0530 Lupin has announced that YL Biologics Limited (YLB), a joint venture between Lupin’s subsidiary Lupin Atlantis Holdings SA (LAHSA) and Yoshindo Inc. in Japan, and Lupin (through its Japanese subsidiary, Kyowa Pharmaceutical Industry Co. Ltd) have received an approval to manufacture and sell their biosimilar Etanercept in Japan. The approval to treat moderate to severe Rheumatoid Arthritis (RA) and Juvenile Idiopathic Arthritis was received today. Commenting on this development, Nilesh Gupta, Managing Director, Lupin Limited stated, “We are delighted to bring our first biosimilar to market in Japan. Etanercept is a very complex product and this was a truly world-class development. The timely approval of our filing which involved successfully addressing the PMDA queries as well as going through a PMDA inspection for our Biosimilar drug substance facility in Pune, India speaks volumes of the quality that we have been able to build into the product, our process and our facilities. We now look forward to bringing this important product to Japanese patients. We have a carefully selected, high-value pipeline of biosimilars going forward and are committed to advancing research and development in this space. This is part of our overall move to evolve our complex generic portfolio and offer better access to affordable and high-quality products for patients across the world.” Dr. Toshihiko Hibino, President, YL Biologics Limited emphasized that “We are delighted to receive the approval from the authorities and this makes it a significant milestone for the JV. YLB will continue to offer high quality yet cost-effective medical solutions to the Japanese patients. YLB113 is one such product that reduces the healthcare burden of patients suffering from Rheumatoid Arthritis (RA) and Juvenile Idiopathic Arthritis”. Dr. Cyrus Karkaria, President, Lupin Biotech said, “Etanercept is used globally in the fight against a range of severe autoimmune disorders. The successful filing and eventual approval of YLB113 is a major step in the fight against these diseases, and will allow access to an effective, affordable equivalent. After significant investment in our biotechnology R&D division over the years, this is the first biosimilar for regulated markets developed in-house at Lupin and the first etanercept biosimilar developed by an Indian pharmaceutical player. It is an important achievement for us that sets the tone for future biosimilar development.” In February 2018, YL Biologics announced the successful completion of the global Phase III study of their biosimilar Etanercept (YLB113). The study was a multi-country randomized double-blind controlled trial of 52 weeks duration which included more than 500 patients with rheumatoid arthritis (RA) across 11 countries. It compared YLB113’s efficacy and safety directly against Enbrel®. The study was conducted at 110 rheumatology clinics across Japan, Europe and India. This study included over 260 Japanese patients from 62 rheumatology clinics, a scale that is distinctive for a global RA trial. Based on the results of this Phase III study, YLB and Lupin (through its Japanese subsidiary, Kyowa Pharmaceutical Industry Co. Ltd) submitted an NDA to the Pharmaceutical and Medical Devices Agency (PMDA) in Japan in March 2018. In addition to addressing queries on its applications, Lupin Biotech facilities at Pune, India were inspected by the PMDA, with successful outcome.   ]]> <![CDATA[Lupin receives FDA approval for Sildenafil Tablets]]> https://biospectrumindia.com/news/95/13182/lupin-receives-fda-approval-for-sildenafil-tablets.html https://biospectrumindia.com/news/95/13182/lupin-receives-fda-approval-for-sildenafil-tablets.html Mon, 25 Mar 2019 13:15:00 +0530 Lupin has announced that it has received approval for its Sildenafil Tablets USP, 25 mg, 50 mg, and 100 mg from the United States Food and Drug Administration (FDA) to market a generic version of Pfizer Inc’s Viagra Tablets, 25 mg, 50 mg, and 100 mg. Lupin’s Sildenafil Tablets USP, 25 mg, 50 mg, and 100 mg, is the generic version Pfizer Inc’s Viagra Tablets, 25 mg, 50 mg, and 100 mg. Sildenafil Tablets are a phosphodiesterase-5 (PDE5) inhibitor indicated for the treatment of erectile dysfunction (ED). Sildenafil Tablets USP, 25 mg, 50 mg, and 100 mg had an annual sales of approximately USD 611 million in the US.   ]]> <![CDATA[Alembic Pharma set to launch allergic conjunctivitis drug ]]> https://biospectrumindia.com/news/95/13167/alembic-pharma-set-to-launch-allergic-conjunctivitis-drug-.html https://biospectrumindia.com/news/95/13167/alembic-pharma-set-to-launch-allergic-conjunctivitis-drug-.html Fri, 22 Mar 2019 16:25:00 +0530 Alembic Pharmaceuticals Limited has received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Azelastine Hydrochloride Ophthalmic Solution, 0.05%. The approved ANDA is therapeutically equivalent to the reference listed drug (RLD), Optivar Ophthalmic Solution, 0.05%, of Mylan Specialty L.P. (Mylan). Azelastine Hydrochloride Ophthalmic Solution 0.05% is indicated for the treatment of itching of the eye associated with allergic conjunctivitis. Azelastine Hydrochloride Ophthalmic Solution, 0.05%, has an estimated market size of US$ 8.5 million for twelve months ending December 2018 according to IQVIA. Alembic now has a total of 89 ANDA approvals (76 final approvals and 13 tentative approvals) from USFDA. ]]> <![CDATA[Lupin launches generic Thyroid tablets in The US]]> https://biospectrumindia.com/news/95/13166/lupin-launches-generic-thyroid-tablets-in-the-us.html https://biospectrumindia.com/news/95/13166/lupin-launches-generic-thyroid-tablets-in-the-us.html Fri, 22 Mar 2019 15:50:00 +0530 Pharma major Lupin Limited (Lupin) announced the launch of Levothyroxine Sodium Tablets USP, having received an approval from the United States Food and Drug Administration (FDA) earlier. Lupin’s Levothyroxine Sodium Tablets USP, is the generic equivalent of AbbVie, Inc’s Synthroid® Tablets. It is indicated for Hypothyroidism: As replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism. It is also used for Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression: As an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer. Levothyroxine Sodium Tablets, 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg, 200 mcg, and 300 mcg had an annual sale of approximately USD 2.5 billions in the U.S (IQVIA MAT January 2019). ]]> <![CDATA[J&J joins forces with Monash University to advance novel technology ]]> https://biospectrumindia.com/news/95/13161/jj-joins-forces-with-monash-university-to-advance-novel-technology-.html https://biospectrumindia.com/news/95/13161/jj-joins-forces-with-monash-university-to-advance-novel-technology-.html Fri, 22 Mar 2019 12:05:00 +0530 Janssen Pharmaceutica N.V, one of the Janssen Pharmaceutical Companies of Johnson & Johnson has announced that it has entered into a sponsored research agreement with the Monash Institute of Pharmaceutical Sciences (MIPS) at Monash University to advance the development of an inhaled version of oxytocin to help prevent and manage Post-Partum Hemorrhage (PPH). PPH, a condition of excessive blood loss after birth, is the leading cause of maternal mortality globally, resulting in an estimated 60,000 deaths per year, overwhelmingly in resource-limited countries. Jaak Peeters, Global Head, Johnson & Johnson Global Public Health, Janssen-Cilag GmBH said, “When you consider the lifetime risk of dying for a woman in child birth is 23 times higher in resource-limited settings than anywhere else you must act if you have the scientific capabilities to potentially help overcome that inequity. We hope to address this significant unmet need by helping accelerate the development of what would be a truly life-saving innovation and give women and their families everywhere the same chance at life.” Most deaths resulting from PPH could be avoided if access to suitable medical innovation were available. It is effectively managed in developed countries using the gold standard therapy, oxytocin, a manufactured form of a natural hormone. Accessibility to quality oxytocin in resource-poor countries is however limited as current products are only available in an injectable form requiring supply and storage under refrigerated conditions and trained personnel to administer the product safely. This new research agreement builds on an existing collaboration between MIPS and GSK which was established in 2014. Formulated as a dry powder, inhaled oxytocin would eliminate the need for refrigerated storage conditions, while delivering oxytocin via a powder inhaler could ease its administration allowing for its use by frontline health workers, birth attendants and mothers themselves. Combined, this innovative approach also aims to support attended births outside of medical facilities. Professor Michelle McIntosh, Monash Institute of Pharmaceutical Sciences, Monash University who has pioneered the inhaled delivery of oxytocin said, “This is an exciting opportunity to expand this collaboration between industry and academia to develop an important healthcare innovation that aims to address a critical unmet medical need. There is a massive ripple effect when a mother dies – it's a very significant burden for these families and communities, and we are committed to bringing the gold-standard care to all mothers.” Kathy Connell, Senior Director, New Ventures, Australia & New Zealand, Johnson & Johnson Innovation said, “Australia is a thriving hub of life science innovation with a proven track-record of delivering innovative healthcare solutions for people globally. This latest agreement between Johnson & Johnson and Monash University, an internationally renowned leader in pharmacy and pharmacology, builds on our legacy of innovative academic-industry collaborations in Australia focused on developing life-saving treatments for the highest unmet needs.” The collaboration was facilitated by Johnson & Johnson Innovation. The announcement was made recently at the Johnson & Johnson Innovation Partnering Office at Monash which was established in January 2018 by Johnson & Johnson Innovation, Australia’s Victorian Government and Monash University to enable access by Victorian researchers and companies to the expertise across Johnson & Johnson’s scientist research, investor and commercial operations. ]]> <![CDATA[J&J joins forces with Monash University-led Partnership to advance novel technology ]]> https://biospectrumindia.com/news/95/13160/jj-joins-forces-with-monash-university-led-partnership-to-advance-novel-technology-.html https://biospectrumindia.com/news/95/13160/jj-joins-forces-with-monash-university-led-partnership-to-advance-novel-technology-.html Fri, 22 Mar 2019 11:55:00 +0530 Janssen Pharmaceutica N.V, one of the Janssen Pharmaceutical Companies of Johnson & Johnson has announced that it has entered into a sponsored research agreement with the Monash Institute of Pharmaceutical Sciences (MIPS) at Monash University to advance the development of an inhaled version of oxytocin to help prevent and manage Post-Partum Hemorrhage (PPH). PPH, a condition of excessive blood loss after birth, is the leading cause of maternal mortality globally, resulting in an estimated 60,000 deaths per year, overwhelmingly in resource-limited countries. Jaak Peeters, Global Head, Johnson & Johnson Global Public Health, Janssen-Cilag GmBH said, “When you consider the lifetime risk of dying for a woman in child birth is 23 times higher in resource-limited settings than anywhere else you must act if you have the scientific capabilities to potentially help overcome that inequity. We hope to address this significant unmet need by helping accelerate the development of what would be a truly life-saving innovation and give women and their families everywhere the same chance at life.” Most deaths resulting from PPH could be avoided if access to suitable medical innovation were available. It is effectively managed in developed countries using the gold standard therapy, oxytocin, a manufactured form of a natural hormone. Accessibility to quality oxytocin in resource-poor countries is however limited as current products are only available in an injectable form requiring supply and storage under refrigerated conditions and trained personnel to administer the product safely. This new research agreement builds on an existing collaboration between MIPS and GSK which was established in 2014. Formulated as a dry powder, inhaled oxytocin would eliminate the need for refrigerated storage conditions, while delivering oxytocin via a powder inhaler could ease its administration allowing for its use by frontline health workers, birth attendants and mothers themselves. Combined, this innovative approach also aims to support attended births outside of medical facilities. Professor Michelle McIntosh, Monash Institute of Pharmaceutical Sciences, Monash University who has pioneered the inhaled delivery of oxytocin said, “This is an exciting opportunity to expand this collaboration between industry and academia to develop an important healthcare innovation that aims to address a critical unmet medical need. There is a massive ripple effect when a mother dies – it's a very significant burden for these families and communities, and we are committed to bringing the gold-standard care to all mothers.” Kathy Connell, Senior Director, New Ventures, Australia & New Zealand, Johnson & Johnson Innovation said, “Australia is a thriving hub of life science innovation with a proven track-record of delivering innovative healthcare solutions for people globally. This latest agreement between Johnson & Johnson and Monash University, an internationally renowned leader in pharmacy and pharmacology, builds on our legacy of innovative academic-industry collaborations in Australia focused on developing life-saving treatments for the highest unmet needs.” The collaboration was facilitated by Johnson & Johnson Innovation. The announcement was made recently at the Johnson & Johnson Innovation Partnering Office at Monash which was established in January 2018 by Johnson & Johnson Innovation, Australia’s Victorian Government and Monash University to enable access by Victorian researchers and companies to the expertise across Johnson & Johnson’s scientist research, investor and commercial operations. ]]> <![CDATA[Syngene International wins CMO Leadership Awards]]> https://biospectrumindia.com/news/95/13158/syngene-international-wins-cmo-leadership-awards.html https://biospectrumindia.com/news/95/13158/syngene-international-wins-cmo-leadership-awards.html Fri, 22 Mar 2019 11:25:00 +0530 Syngene International Ltd., an innovation focused global discovery, development and manufacturing organization, announced that it has won the CMO Leadership Awards presented by Life Science Leader magazine. This award was announced on the sidelines of the DCAT™ Week held from March 18-21, 2019 in New York City. The CMO Leadership Awards was instituted by Life Science Leader magazine in 2011 to recognize leading contract manufacturing organizations globally. The magazine caters to the life sciences industry and provides insight into areas such as research and development, manufacturing, regulatory landscape, clinical trials. Syngene was successfully rated across the six categories - Capabilities, Compatibility, Expertise, Quality, Reliability and Service – that were used to gauge the eventual winner. For the 2019 CMO Leadership Awards, Life Science Leader teamed up with Industry Standard Research (ISR) to assess more than 120 contract manufacturers and determine the award recipients. Jonathan Hunt, Chief Executive Officer, Syngene International, said, “We are delighted to receive the CMO Leadership Award. This award is a recognition of the exemplary work done by our staff to deliver truly excellent service to our growing global customer base. Syngene’s track record of delivering innovation at the highest global quality standards is a real differentiator. Our investments in expanded manufacturing capacities, for both small and large molecules, ensure we can be a ‘one stop’ solution provider for our clients across all stages of the drug discovery, development and manufacturing value chain.” ]]> <![CDATA[Pharmexcil to organize India Pavilion at Korea Pharm ]]> https://biospectrumindia.com/news/95/13156/pharmexcil-to-organize-india-pavilion-at-korea-pharm-.html https://biospectrumindia.com/news/95/13156/pharmexcil-to-organize-india-pavilion-at-korea-pharm-.html Thu, 21 Mar 2019 15:55:00 +0530 Pharmaceuticals Export Promotion Council of India (Pharmexcil) is organizing India Pavilion at Korea Pharm, being held at Korea International Exhibition Center (KINTEX), Goyang, South Korea from 16th-18th April 2019. This is the 5th time Pharmexcil is participating in the event. Korea Pharm is an exhibition focused for APIs, Chemicals, Laboratory and Packaging materials. This is the only exhibition supported by the Korea Food & Drug Administration (KFDA) and Korea Pharmaceutical Industry (KPMA). Korea Pharm & Bio is an international trade fair for the pharmaceutical industry in Korea and presents its visitors products and raw materials for the pharmaceutical industry. The government of Korea has announced capital and institutional support to boost Pharmaceutical Manufacturing in Korea and thereby making Korea is one of the top 7 global pharmaceutical producing countries by 2020. ]]> <![CDATA[C2 PHARMA acquires Digoxin API portfolio from Nobilus Ent]]> https://biospectrumindia.com/news/95/13136/c2-pharma-acquires-digoxin-api-portfolio-from-nobilus-ent.html https://biospectrumindia.com/news/95/13136/c2-pharma-acquires-digoxin-api-portfolio-from-nobilus-ent.html Tue, 19 Mar 2019 13:35:00 +0530 C2 PHARMA s.a.r.l., a phytochemical and chemical pharmaceutical manufacturing and distribution group, has acquired the Digoxin API product portfolio of Polish company, Nobilus Ent, self-developed and inherited from Roche/Galenus Mannheim. Through the agreement, C2 PHARMA is the product owner, and Nobilus is a manufacturing partner and releasing entity for the API. Parallel manufacturing to ensure redundancy is supported by long-term partner, Laurus Labs, an India-based API manufacturer with an impeccable track record.  Since 2014, Digoxin API availability has been frequently and severely disrupted causing shortages of product due to high levels of impurities and an unreliable supply chain. To mitigate the expected future impact of those Digoxin API shortages, C2 PHARMA has taken various actions, including this recent agreement, as well as setting up a fully independent supply chain for digitalis leaves and investing in a brand new, dedicated, state-of-the-art manufacturing facility with Laurus Labs in India. Tech transfer has been completed and validated, and the Digoxin API is currently in production at the Nobilus Ent and Laurus Lab sites. Purchases can be made directly from C2 PHARMA. ]]> <![CDATA[EC approves Roche’s MabThera for a rare autoimmune disease]]> https://biospectrumindia.com/news/95/13133/ec-approves-roches-mabthera-for-a-rare-autoimmune-disease.html https://biospectrumindia.com/news/95/13133/ec-approves-roches-mabthera-for-a-rare-autoimmune-disease.html Tue, 19 Mar 2019 12:05:00 +0530 Roche announced that the European Commission has approved MabThera® (rituximab) for the treatment of adults with moderate to severe pemphigus vulgaris (PV), a rare condition characterised by progressive painful blistering of the skin and/or mucous membranes. Extensive blistering can lead to serious, life-threatening fluid loss, infection and/or death. MabThera is the first biologic therapy approved by the European Commission for PV and the first major advancement in the treatment of the disease in more than 60 years. Following approval by the US Food and Drug Administration (FDA) in June 2018 and current decision, MabThera is now approved to treat four autoimmune diseases in the US and Europe. The European approval is based on data from the phase III Ritux 3 trial, a Roche-supported randomised controlled study, conducted in France, which evaluated MabThera plus a tapering regimen of oral corticosteroids (CS) compared to a standard dose of CS alone, as a first-line treatment in patients with newly diagnosed moderate to severe pemphigus.  Recently, an international panel of experts, the International Bullous Disease Group, published new recommendations on the diagnosis and management of pemphigus in the Journal of the American Academy of Dermatology, and recommended the use of an anti-CD20 monoclonal antibody, such as MabThera combined with a tapering regimen of oral CS, as a first-line therapy option for moderate to severe pemphigus. ]]> <![CDATA[Dr Reddy’s launches advanced service portal for customers]]> https://biospectrumindia.com/news/95/13132/dr-reddys-launches-advanced-service-portal-for-customers.html https://biospectrumindia.com/news/95/13132/dr-reddys-launches-advanced-service-portal-for-customers.html Tue, 19 Mar 2019 10:55:00 +0530 Dr. Reddy’s Laboratories Ltd. announces the launch of its advanced B2B Customer Service Portal “XCEED.” Fully focused on meeting the growing demand for Dr. Reddy’s portfolio of generic active pharmaceutical ingredients (APIs), the customer service portal significantly increases the operational efficiency in doing business with Dr. Reddy’s. The no-boundaries platform designed based on customers’ insights and feedback, is a huge step forward in providing an advanced customer experience and facilitating collaboration. Customers are now able to manage the whole business process in real time, from ordering samples to submit and track their orders, but also to closely interact with Dr. Reddy’s interdisciplinary support team and much more. Catering to leading innovator and generic companies across the U.S., Europe, Latin America, Japan, Korea and other emerging markets, Dr. Reddy’s is recognized as one of the largest API suppliers. The launch of XCEED gives now instant access to an industry leading portfolio which spans across a wide range of indications and complex molecules such as steroids, peptides or highly potent APIs (HPAPI). “We strive to provide the best service experience for our customers and the launch of our Customer Service Portal “XCEED” strongly underlines our commitment to meet and exceed customer expectations,” commented Deepak Sapra, Senior Vice President and Global Head of Custom Pharma Services and Active Pharmaceutical Ingredients business at Dr. Reddy’s Laboratories. “We are confident that XCEED will increase the operational efficiency for our partners by enabling them to transact online and access real time information about their business and products with Dr. Reddy's. This will further enable us to support them in their mission to bring medicines to patients faster.” The platform will be presented for the first time to customers during DCAT week in New York from March 18-21, 2019 and will be available to API customers across the globe during the next week. ]]> <![CDATA[SCHOTT KAISHA's five city roadshow concludes with resounding success]]> https://biospectrumindia.com/news/95/13129/schott-kaishas-five-city-roadshow-concludes-with-resounding-success.html https://biospectrumindia.com/news/95/13129/schott-kaishas-five-city-roadshow-concludes-with-resounding-success.html Tue, 19 Mar 2019 09:00:00 +0530 In a first-ever industry initiative, leading pharmaceutical packaging company SCHOTT KAISHA successfully concluded its 5-city roadshow, bringing together industry experts, R&D specialists, business and sales leaders for discussions on the latest technological advancements and best practices that lead to drug safety. Held over 2 weeks, the events gave participants a clear understanding on the importance of conversion process in tubular glass manufacturing, and showcased SCHOTT KAISHA’s upcoming product portfolio, tailor-made design and development capabilities. Rishad Dadachanji, Director, SCHOTT KAISHA shared, “the Indian packaging industry is undergoing rapid growth and we have always been committed to address the demands and challenges of our customers. Hence, we always work together with our partners to deliver better integrated lines of solutions and services. We are extremely happy with the response at the roadshow. This has helped us further strengthen our position in the industry as a catalyst of innovation and technology. As a key takeaway, we have decided to work even closer with our stakeholders and meet their demands by investing in yet another manufacturing unit in Umarsadi, Gujarat as well as plan to set up an entirely new plant in northern India.” With fresh investments in new sites in Gujarat and North India, expansion and upgradation of existing plants in Daman and Jambusar, SCHOTT KAISHA’s financial commitment will further increase by upto INR 500 crores between 2018 and 2020. The increased capacity will cater to the growing demand of ampoules, vials, syringes, cartridges and sterile portfolio. Through this increased production capacity, the company is focussing on catering to the domestic market first, with a current supply to export ratio of 75:25. Major Customers of SCHOTT KAISHA played an active role during the roadshow, in giving a feedback from an end-user perspective. Mr. Ajay Bapat from Emcure shared his impression, “This is a great initiative by SCHOTT KAISHA. Companies like ours, who are closest to the end-users, look forward to such events which gives us valuable insights on solutions and innovations available for the final consumer. In any industry, and more particularly, for pharmaceuticals where customer’s health is at stake, it is important to have a feedback mechanism in place. Being an informal gathering of professionals from all spheres, the event gave participants an opportunity to share challenges and demands of their customers. Now, it becomes even more important for us to work closely to overcome challenges.” Similarly, the roadshow provided a platform for partners of SCHOTT KAISHA to showcase their unique offerings to potential clients. Severine Duband, Global Category Manager, Nemera said, “Most events in the industry generally cover a wide spectrum of offerings and cater to a mix audience. However, such a roadshow is much more targeted and caters to our specific audience. Hence, this is a much more effective platform for us resulting in quality over quantity in terms of prospective business opportunities.” Other partners included global industry leaders such as ACE Technologies, Aptar Pharma, Datwyler, Kaisha Lifesciences, Nemera, Packwell Industries, Shakai Packaging Pvt. Ltd., Smart Skin Technologies, Snowbell Machines Pvt. Ltd., Sovereign Pharma Pvt. Ltd. and Vanrx Pharmasystems Inc. Jayant Joshi, Managing Partner of Shreedhar Group, distributors for VANRX in India shared, “We appreciate this association as it is the first time that so many players – representing foreign brands and local players have come together on a common platform. We use SCHOTT KAISHA products and in fact, design our machines accordingly. Such events through the company are instrumental for us to get closer to our customers, gather new learnings and, in turn evolve our solutions.” Today, India is undoubtedly a huge pharmaceutical market for the world, exerting unmatched strength in manufacturing of generic drugs for US and other global markets. With the Indian pharmaceutical packaging market estimated at INR 147.8 billion in 2017 and expected to reach INR 245.5 billion by the end of 2023, there is huge demand for an increased supply of high quality primary packaging material. SCHOTT KAISHA has always given preference to a ‘quality by design’ approach, benchmark manufacturing and quality control processes using breakthrough inspection technology, combined with best-in-class components. ]]> <![CDATA[Glenmark receives ANDA approval for Clindamycin and Benzoyl Peroxide Gel, 1%|5%]]> https://biospectrumindia.com/news/95/13111/glenmark-receives-anda-approval-for-clindamycin-and-benzoyl-peroxide-gel-15.html https://biospectrumindia.com/news/95/13111/glenmark-receives-anda-approval-for-clindamycin-and-benzoyl-peroxide-gel-15.html Fri, 15 Mar 2019 11:45:00 +0530 Glenmark Pharmaceuticals Inc., has been granted final approval by the United States Food & Drug Administration for Clindamycin and Benzoyl Peroxide Gel, 1%|5%, a generic version of BenzaClin® Gel, 1%|5%, of Valeant Bermuda. According to IQVIATM sales data for the 12 month period ending January 2019, the BenzaClin® Gel, 1%|5% market achieved annual sales of approximately $99.4 million. Glenmark’s current portfolio consists of 151 products authorized for distribution in the U.S. marketplace and 53 ANDA’s pending approval with the U.S. FDA.   ]]> <![CDATA[Zydus set to market generic anti-diabetic drug]]> https://biospectrumindia.com/news/95/13110/zydus-set-to-market-generic-anti-diabetic-drug.html https://biospectrumindia.com/news/95/13110/zydus-set-to-market-generic-anti-diabetic-drug.html Fri, 15 Mar 2019 11:40:00 +0530 Zydus Cadila is an innovative, global pharmaceutical company that discovers, develops, manufactures and markets a broad range of healthcare therapies The company has received the tentative approval from the USFDA to market Sitagliptin and Metformin Hydrochloride Extended-Release Tablets, (US RLD – JANUMET® XR), 50 mg/500 mg, 50 mg/1,000 mg and 100 mg/1,000 mg. It will be manufactured at the group’s formulations manufacturing facility at SEZ, Ahmedabad. It contains two oral antidiabetic medications used in the management of type 2 diabetes - sitagliptin and metformin hydrochloride extended-release. The group now has 255 approvals and has so far filed over 350 ANDAs since the commencement of the filing process in FY 2003-04. ]]> <![CDATA[Roche, Jothydev’s Diabetes Research Centre set up CoE]]> https://biospectrumindia.com/news/95/13107/roche-jothydevs-diabetes-research-centre-set-up-coe.html https://biospectrumindia.com/news/95/13107/roche-jothydevs-diabetes-research-centre-set-up-coe.html Fri, 15 Mar 2019 09:00:00 +0530 Roche, a pioneer in innovative diabetes technologies, has signed a Memorandum of Understanding (MOU) with Jothydev’s Diabetes Research Centre to develop a Centre of Excellence to fight diabetes across South India. Roche and Jothydev’s Diabetes Research Centre (JDC) have their visions aligned in having a patient-centric approach to healthcare. The Centre of Excellence will deepen education and raise awareness about diabetes and the different ways it can be treated. Roche will facilitate training and education for healthcare professionals at this Centre in order to upgrade their skill sets by teaching them about iPDM (Integrated Personalised Diabetes Management), a new model of diabetes treatment. The company will also provide clinical research and patient support. As per the International Diabetes Federation (IDF), about 425 million people are affected with DM worldwide, and this number is estimated to reach 629 million by the year 2045. India ranks second in the world, closely following China, with almost 73 million Indians living with diabetes. With a projected prevalence of over 134 million, India is estimated to surpass China by the year 2045. Jothydev’s Diabetes Research Centres(JDC), Kerala is a pioneer in evidence based technologies, telemedicine and team based care with a proven track record over two decades. The major strength of this organization is the practice of structured glucose monitoring programs integrated with training, teaching and customized treatment protocols. JDC has been in the forefront introducing the safest and the latest therapies and technologies such as newer oral medications, insulin, insulin pumps, glucose sensors and AI based platforms.  JDC is an ISO certified centre and is the International Diabetes Federation (IDF) approved Centre of Excellence in Diabetes Care and Excellence in Education in Kerala. The centre is known for its unique telemedicine-based follow-up (DTMS®) facility and virtual consultations and caters to the requirements of thousands of patients in more than 25 countries. The core strength of the centre is its trained team of physicians and the multidisciplinary team involved in patient care. The centre is also known for original research in the field of diabetes, most of which have been published in indexed medical journals and presented at scientific conventions at international (USA, Europe, Australia, Canada etc.) and national level. The centre also publishes a free monthly internet-based diabetes newsletter ‘JDC Diabetes Gems’ since 2008 to impart education to the patients and medical fraternity.  Recognising Jothydev’s Diabetes Research Centre as a pioneer in the fight against diabetes, Dr. Gaurav Laroia, General Manager, Roche Diabetes Care India said, “With the government’s focus on diabetes, there is tremendous opportunity for us to partner closely with different stakeholders to help manage the rising prevalence of diabetes in India. Roche Diabetes Care, India has been collaborating with various critical stakeholders to tackle healthcare challenges associated with diabetes care. With the MOU to set up the Centre of Excellence in the treatment of diabetes across India, it pairs our expertise in advanced diabetes management with Dr. Jothydev’s experience in holistic diabetes care.” Dr. Jothydev Kesavadev, the founder Chairman and Managing Director of Jothydev’s Diabetes Research said that “Diabetes is a dynamic disease. The high failure rates in the current treatment are often due to the underuse of life-saving, available and emerging technologies. The Centre of Excellence will help in delivering practice changing and life-saving technologies in diabetes.  Medication and behavioural therapies can bring about a change only when integrated with patient-friendly devices and physician-friendly interpretations. This partnership is committed to delivering training and expertise to empower the physicians to serve society and to save the treatment costs and the lives of those affected with diabetes.” With the development of science and technology, newer methods of diagnosis, monitoring and treatment, diabetes today can be managed far more effectively. Nevertheless, several patients still struggle to reach therapeutic targets and are, therefore, at an increased risk of developing complications. Thus, patient awareness, active participation in self-care and constant research to prevent both acute and long-term complications are equally important for effective management of diabetes. Our mission is to deliver holistic diabetes care for people with diabetes across the care continuum, including physicians and caregivers, to ensure better disease control and management. ]]> <![CDATA[LANXESS' Virkon S helps contain Bird Flu outbreak in Patna zoo]]> https://biospectrumindia.com/news/95/13108/lanxess-virkon-s-helps-contain-bird-flu-outbreak-in-patna-zoo.html https://biospectrumindia.com/news/95/13108/lanxess-virkon-s-helps-contain-bird-flu-outbreak-in-patna-zoo.html Thu, 14 Mar 2019 21:15:00 +0530 Virkon S, one of the world's leading veterinary disinfectants, from specialty chemicals company LANXESS, has helped contain the recent outbreak of Avian Influenza (commonly known as Bird Flu) in the Sanjay Gandhi Biological Park, Patna in Bihar. Incidentally, the presence of H5N1 strain of Avian Influenza was first detected in Bihar from the viscera of dead birds in six villages of Asarganj block in Munger district of Bihar on December 21. The report of the bird flu outbreak led to the culling of over 1400 birds in Munger district alone and another 100 in Patna. Virkon S is recognized worldwide as the disinfectant of choice for the emergency disease control of Avian Influenza. Sanitization work for the containment of bird flu in Patna zoo was successfully performed by local authorities and Virkon S has been independently proven to be effective against highly pathogenic Avian Influenza virus strains. It has also been sprayed in the lion, tiger and leopard enclosures as a precautionary measure. Studies carried out by independent international test laboratories have proven that Virkon S inactivates highly pathogenic Avian Influenza strains with a short contact time and in the face of challenging farm conditions such as heavy organic challenge, dilution by rain water and a wide range of temperatures, and the broad range of disease-causing organisms that can exist on farms. Virkon S is recommended for use at a dilution rate of 1:100 for preventative and continuous biosecurity measures to provide high levels of efficacy. The highly efficacious nature of Virkon S has been demonstrated in a series of tests against members of the orthomyxoviridae virus family (including Avian influenza H5N1), and, by association, would be expected to inactivate the H5N8 strain. In recent years, India has suffered multiple outbreaks of Avian Influenza H5N1 and it is becoming a growing concern for poultries. Various factors like high density of poultry population, movement of poultry and poultry products from infected areas within the country and mixed rearing of chickens has made India vulnerable to primary incursion of Avian Influenza. The main source of such outbreaks are the migratory birds that fly in from Siberia into India and is further spread by the inward movement of the infected birds within the country. Anand Muthureddy, Head – Business Unit Material Protection Products, LANXESS India, commented, “Our product Virkon S has proven to be highly effective in tackling such highly contagious diseases as we have put in a lot of R&D and testing behind it to make it a potent measure against such diseases and outbreaks. We are happy to be able to help the local authorities in containing the avian influenza outbreak effectively.”   ]]> <![CDATA[Zydus gets USFDA approval for hypertension drug ]]> https://biospectrumindia.com/news/95/13088/zydus-gets-usfda-approval-for-hypertension-drug-.html https://biospectrumindia.com/news/95/13088/zydus-gets-usfda-approval-for-hypertension-drug-.html Wed, 13 Mar 2019 14:10:00 +0530 Zydus Cadila has received the final approval from the USFDA to market Atenolol and Chlorthalidone Tablets USP (US RLD – Tenoretic®), 50 mg/25 mg and 100 mg/25 mg. It will be manufactured at the group’s formulations manufacturing facility at SEZ, Ahmedabad. This medication is used to treat high blood pressure (hypertension). Lowering high blood pressure helps prevent strokes, heart attacks and kidney problems. Atenolol belongs to a class of drugs known as beta blockers. It works by blocking the action of certain natural chemicals in your body, such as epinephrine on the heart and blood vessels. This effect lowers the heart rate, blood pressure and strain on the heart. Chlorthalidone is a ‘water pill’ (diuretic) and causes the body to get rid of extra salt and water. It also helps to relax the blood vessels so that blood can flow easily. The group now has 253 approvals and has so far filed over 330 ANDAs since the commencement of the filing process in FY 2003-04 ]]> <![CDATA[Zydus gets USFDA approval for hypertension drug ]]> https://biospectrumindia.com/news/95/13089/zydus-gets-usfda-approval-for-hypertension-drug-.html https://biospectrumindia.com/news/95/13089/zydus-gets-usfda-approval-for-hypertension-drug-.html Wed, 13 Mar 2019 14:10:00 +0530 Zydus Cadila has received the final approval from the USFDA to market Atenolol and Chlorthalidone Tablets USP (US RLD – Tenoretic®), 50 mg/25 mg and 100 mg/25 mg. It will be manufactured at the group’s formulations manufacturing facility at SEZ, Ahmedabad. This medication is used to treat high blood pressure (hypertension). Lowering high blood pressure helps prevent strokes, heart attacks and kidney problems. Atenolol belongs to a class of drugs known as beta blockers. It works by blocking the action of certain natural chemicals in your body, such as epinephrine on the heart and blood vessels. This effect lowers the heart rate, blood pressure and strain on the heart. Chlorthalidone is a ‘water pill’ (diuretic) and causes the body to get rid of extra salt and water. It also helps to relax the blood vessels so that blood can flow easily. The group now has 253 approvals and has so far filed over 330 ANDAs since the commencement of the filing process in FY 2003-04 ]]> <![CDATA[Zydus gets final USFDA nod to sell Potassium Chloride capsules ]]> https://biospectrumindia.com/news/95/13087/zydus-gets-final-usfda-nod-to-sell-potassium-chloride-capsules-.html https://biospectrumindia.com/news/95/13087/zydus-gets-final-usfda-nod-to-sell-potassium-chloride-capsules-.html Wed, 13 Mar 2019 14:00:00 +0530 Zydus Cadila is an innovative, global pharmaceutical company, has received the final approval from the USFDA to market Potassium Chloride Extended-Release Capsules USP (US RLD – Micro-K® Extended-Release Capsules), 8 mEq (600 mg) and 10 mEq (750 mg). It will be manufactured at the group’s formulations manufacturing facility at SEZ, Ahmedabad. This medication is a mineral supplement used to treat or prevent low amounts of potassium in the blood. Potassium helps your cells, kidneys, heart, muscles, and nerves work properly. Some conditions that can lower the body's potassium level include severe prolonged diarrhoea and vomiting, hormone problems such as hyperaldosteronism, or treatment with ‘water pills’/diuretics.  The group now has 254 approvals and has so far filed over 350 ANDAs since the commencement of the filing process in FY 2003-04. ]]> <![CDATA[AstraZeneca enters into research collaboration with Seres Therapeutics]]> https://biospectrumindia.com/news/95/13080/astrazeneca-enters-into-research-collaboration-with-seres-therapeutics.html https://biospectrumindia.com/news/95/13080/astrazeneca-enters-into-research-collaboration-with-seres-therapeutics.html Wed, 13 Mar 2019 10:45:00 +0530 Seres Therapeutics has announced a three-year research collaboration with AstraZeneca. The collaboration will focus on advancing mechanistic understanding of the microbiome in augmenting the efficacy of cancer immunotherapy, including potential synergy with AstraZeneca compounds. Preclinical and early clinical evidence suggests that the composition of the gastrointestinal microbiome impacts clinical response to checkpoint inhibitor immunotherapy and supports the hypothesis that modification of the microbiome may improve outcomes. These data provide strong support for continued research to further understand the microbiome as a predictor of response to checkpoint inhibitors and to elucidate the potential of microbiome therapeutics to augment immunotherapy. Under the collaboration, research will evaluate microbiome-based approaches as a predictor for which patients may respond best to certain cancer immunotherapies. Additionally, SER-401, an investigational microbiome therapeutic, may be studied in combination with AstraZeneca compounds targeting various cancers. The collaboration will apply Seres’ microbiome drug discovery and manufacturing expertise with AstraZeneca’s extensive oncology experience to evaluate the potential for microbiome therapy to improve clinical response when used in conjunction with adjunctive pharmaceutical approaches. Eric Shaff, President and Chief Executive Officer of Seres Therapeutics said, “We are very pleased to be collaborating with AstraZeneca, a global leader in oncology, to advance the development of potential microbiome-based therapies for cancer. Through the activities under this collaboration and in our SER-401 Phase 1b clinical study in metastatic melanoma, we hope to meaningfully advance our understanding of the potential for microbiome therapeutics to magnify the impact of cancer immunotherapy.” Jean-Charles Soria, Senior Vice President, Research & Development Oncology at AstraZeneca said, “Our new collaboration with Seres Therapeutics represents an important opportunity to advance our understanding of the relationship between the microbiome and the immune system’s ability to respond to cancer therapy. Despite progress in the field of immunotherapy, we are only at the tip of the iceberg. Too many patients are still unable to benefit from existing therapies, so we must continue following the science in pursuit of new and innovative solutions.” Under the terms of the exclusive collaboration, AstraZeneca will provide Seres with $20 million in three equal installments over two years, with the first payment due at the start of the agreement. In addition, AstraZeneca will also reimburse Seres for research activity related to the collaboration. Seres will maintain rights to oncology targeted microbiome therapeutic candidates, and AstraZeneca will obtain the option to negotiate for rights to those programs and other inventions arising out of the collaboration.   ]]> <![CDATA[Piramal launches Cinacalcet in the US market]]> https://biospectrumindia.com/news/95/13075/piramal-launches-cinacalcet-in-the-us-market.html https://biospectrumindia.com/news/95/13075/piramal-launches-cinacalcet-in-the-us-market.html Tue, 12 Mar 2019 20:15:00 +0530 Piramal Enterprises Limited has announced that one of its partners for its global pharma businesses - Slate Run Pharmaceuticals LLC. (‘Slate Run’), has launched generic cinacalcet hydrochloride tablets (30mg, 60mg and 90mg) in the United States. Piramal’s subsidiary, Piramal Healthcare (UK) Limited (‘PHL’), has partnered with Slate Run Pharmaceuticals with the goal of developing a non-infringing formulation of cinacalcet hydrochloride tablets. Cinacalcet tablets are indicated for the treatment of secondary hyperthyroidism (‘HPT’) in adult chronic kidney disease patients on dialysis and hypercalcemia in adult patients with parathyroid carcinoma.  “As part of our patient focus strategy, we are working with global pharmaceutical firms, to co-develop products, where our R&D competencies can bring about a differentiated and cost effective value proposition for the global healthcare system. With world class R&D and fully integrated network of manufacturing capabilities across the globe, for both drug substance and drug product, Piramal is uniquely positioned to solve both complex chemistries and formulation challenges in the pharmaceutical domain with innovative solutions for partners.” said Vivek Sharma, CEO – Piramal Pharma Solutions, Piramal Group. PHL received the final Abbreviated New Drug Application (‘ANDA’) approval for its generic abbreviated bio-equivalent (‘AB’) rated version of Amgen Inc.’s Sensipar® (cinacalcet hydrochloride) tablets on August 1, 2018. Piramal received a favourable US district court ruling which holds that Piramal’s generic version does not infringe any of the asserted claims of Amgen’s Patent No. 9,375,405. Amgen has filed an appeal which is currently pending in the U.S. Court of Appeals for the Federal Circuit. ]]> <![CDATA[Piramal Critical Care announces launch of Mitigo in the US]]> https://biospectrumindia.com/news/95/13066/piramal-critical-care-announces-launch-of-mitigo-in-the-us.html https://biospectrumindia.com/news/95/13066/piramal-critical-care-announces-launch-of-mitigo-in-the-us.html Tue, 12 Mar 2019 10:40:00 +0530 Piramal Critical Care, a global leader in anesthesia, pain management, and intrathecal therapy, today announced the launch of MITIGO™ (Morphine Sulfate Injection, USP – Preservative-free) in 10 mg/mL and 25 mg/mL concentrations in the US market. Piramal Critical Care will continue to work with wholesalers, hospitals, interventional pain doctors, and pain management centres across the country to ensure availability of MITIGO™ for patients with intractable chronic pain. Peter DeYoung, Chief Executive Officer, Piramal Critical Care said: “Piramal Critical Care has established itself as the leader in U.S. intrathecal therapy with Gablofen® which we have successfully integrated post its acquisition from Mallinckrodt. We are pleased to support intrathecal therapy for pain management with FDA approval and our launch of MITIGO™. We continue to expand our leadership in intrathecal therapy through this launch, as well as in inhaled anesthesia and the injectable anesthesia and pain management drugs that we acquired from Janssen. We stay committed to executing on our strategy to expand our portfolio, address patient and customer needs, and deliver high quality critical care solutions to the market.” MITIGO (Morphine Sulfate Injection, USP – Preservative-free) is an opioid agonist, for use in continuous microinfusion devices indicated only for intrathecal or epidural infusion for the management of intractable chronic pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. ]]> <![CDATA[FDA grants accelerated approval to Roche’s Tecentriq in combination with Abraxane ]]> https://biospectrumindia.com/news/95/13065/fda-grants-accelerated-approval-to-roches-tecentriq-in-combination-with-abraxane-.html https://biospectrumindia.com/news/95/13065/fda-grants-accelerated-approval-to-roches-tecentriq-in-combination-with-abraxane-.html Tue, 12 Mar 2019 09:30:00 +0530 Roche has announced that the US Food and Drug Administration (FDA) has granted accelerated approval to Tecentriq® (atezolizumab) plus chemotherapy (Abraxane® [paclitaxel protein-bound particles for injectable suspension (albumin-bound); nab-paclitaxel]) for the treatment of adults with unresectable locally advanced or metastatic triple-negative breast cancer (TNBC) in people whose tumours express PD-L1, as determined by an FDA-approved test. This indication is approved under accelerated approval based on progression-free survival (PFS). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). The FDA’s Accelerated Approval Programme allows conditional approval of a medicine that fills an unmet medical need for a serious or life-threatening disease or condition. Sandra Horning, Roche’s Chief Medical Officer and Head of Global Product Development said, “The FDA approval of this Tecentriq combination is an important treatment advance for people with PD-L1-positive, metastatic triple-negative breast cancer, a disease with high unmet medical need. This Tecentriq combination is the first cancer immunotherapy regimen to be approved in breast cancer, representing a meaningful step forward in the understanding of this disease.” This accelerated approval is based on data from the Phase III IMpassion130 study, which demonstrated that Tecentriq plus nab-paclitaxel significantly reduced the risk of disease worsening or death (PFS) by 40% compared with nab-paclitaxel alone. Tecentriq is a monoclonal antibody designed to bind with a protein called PD-L1 expressed on tumour cells and tumour-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq may enable the activation of T cells. Tecentriq has the potential to be used as a foundational combination partner with cancer immunotherapies, targeted medicines and various chemotherapies across a broad range of cancers. Tecentriq is already approved in the European Union, United States and more than 85 countries for people with previously treated metastatic non-small cell lung cancer (NSCLC) and for certain types of untreated or previously treated metastatic urothelial carcinoma (mUC). Tecentriq was also recently approved in the United States for the initial treatment of people with metastatic non-squamous NSCLC with no EGFR or ALK genomic tumour aberrations.   ]]> <![CDATA[Lupin receives FDA approval for Atorvastatin Calcium Tablets ]]> https://biospectrumindia.com/news/95/13043/lupin-receives-fda-approval-for-atorvastatin-calcium-tablets-.html https://biospectrumindia.com/news/95/13043/lupin-receives-fda-approval-for-atorvastatin-calcium-tablets-.html Fri, 08 Mar 2019 18:10:00 +0530 Lupin has announced that it has received approval for its Atorvastatin Calcium Tablets USP, 10 mg, 20 mg, 40 mg, and 80 mg, from the United States Food and Drug Administration (FDA) to market a generic version of Pfizer Inc’s Lipitor® Tablets, 10 mg, 20 mg, 40 mg and 80 mg. Lupin’s Atorvastatin Calcium Tablets USP 10 mg, 20 mg, 40 mg, and 80 mg, is the generic version of Pfizer Inc’s Lipitor® Tablets, 10 mg, 20 mg, 40 mg and 80 mg. It is indicated to lower cholesterol in blood for adults and children over 10 years of age. Atorvastatin is also prescribed to lower the risk for heart attack, stroke in patients with cardiovascular diseases, diabetes and other risk factors such as eye problems, kidney diseases or high blood pressure. Atorvastatin Calcium Tablets USP, 10 mg, 20 mg, 40 mg, and 80 mg had annual sales of approximately USD 696 million in the US (IQVIA MAT December 2018). ]]> <![CDATA[West opens new digital technology centre in India]]> https://biospectrumindia.com/news/95/13041/west-opens-new-digital-technology-centre-in-india.html https://biospectrumindia.com/news/95/13041/west-opens-new-digital-technology-centre-in-india.html Fri, 08 Mar 2019 16:00:00 +0530 West Pharmaceutical Services, Inc., a global leader in innovative solutions for injectable drug administration, has officially opened the Company’s new Digital Technology centre (DTC) in Bengaluru, India, a regional hub of digital and technology talent. This state-of-the-art business space will serve as a global centre of excellence for the Company’s Digital and Transformation (D&T) team, alongside teams based in Exton, Pennsylvania, and Eschweiler, Germany. “Our team at West appreciates and understands the important role that technology plays in our business, and the tremendous opportunity it has to enhance the way in which we operate, both externally and internally,” said Silji Abraham, Chief Digital and Transformation Officer, West. “This Digital Technology centre will allow our team to create compelling digital experiences for our global customer base across hemispheres, source talent from India’s fast-growing technology industry and bring forward the latest digital advancements to create insights and value for our customers and team members—ultimately delivering better business results.” The DTC is an important part of West's ongoing efforts to enhance customer engagement through digital marketing, digital manufacturing and automations to accelerate internal and external business processes. Last year, West launched its online Knowledge centre, which provides scientific insight and detailed technical information in the form of scientific reports, bulletins, presentations and literature from our skilled team of professionals. Earlier this year, West also launched its e-commerce platform, a one-stop solution for small quantity containment and delivery products and services from West, designed to improve access to its high-quality product offerings. The DTC spans 17,000 square feet in the heart of Bengaluru’s Outer Ring Road (ORR) technology district. Bengaluru, popularly known as the Silicon Valley of India, hosts millions of engineers from across the country. The Company is currently recruiting for technology professionals in various domains such as network security, cloud architecture, ERP and applications development. These teams will work globally to support the Company’s efforts in e-Commerce, Digital Marketing, the SAP S/4 HANA (ERP)® Cloud business suite roll-out, Digital Manufacturing, and Product Development, including embedded solutions such as artificial intelligence, the Internet of Things, and smart devices. West has had a presence in India since 2014, with a manufacturing plant in Sri City and a commercial office in Hyderabad. ]]> <![CDATA[Lilly to introduce lower-priced Insulin]]> https://biospectrumindia.com/news/95/13028/lilly-to-introduce-lower-priced-insulin.html https://biospectrumindia.com/news/95/13028/lilly-to-introduce-lower-priced-insulin.html Thu, 07 Mar 2019 16:20:00 +0530 Reinforcing our commitment to lower out-of-pocket costs for people who need insulin, Eli Lilly and Company has announced we will introduce a lower-priced version of Humalog® (insulin lispro injection 100 units/mL) in the United States -- providing people with diabetes an insulin option that will have a list price 50 percent lower than the current Humalog list price. "We've engaged in discussions about the price of insulin with many different stakeholders in America's health care system: people living with diabetes, caregivers, advocacy groups, health care professionals, payers, wholesalers, lawmakers, and leading health care scholars," said David A. Ricks, Lilly's chairman and chief executive officer. "Solutions that lower the cost of insulin at the pharmacy have been introduced in recent months, but more people need help. We're eager to bring forward a low-priced rapid-acting insulin.” The lower-priced version will be called Insulin Lispro—the same molecule as Humalog—and will be available in vial and pen options. The list price of a single vial will be $137.35. The list price of a five-pack of KwikPens will be $265.20. Vials and pens of the lower-priced insulin have been manufactured, and Lilly will now work with supply chain partners to make them available in pharmacies as quickly as possible. It will be made available as an authorized generic through a Lilly subsidiary, ImClone Systems. Humalog will also remain available for people who want to continue accessing it through their current insurance plans. Introducing an alternative insulin option allows Lilly to provide a lower-priced insulin more quickly while providing payers time to renegotiate downstream contracts and adjust to new system economics. "While this change is a step in the right direction, all of us in the health care community must do more to fix the problem of high out-of-pocket costs for Americans living with chronic conditions," Ricks said. "We hope our announcement is a catalyst for positive change across the U.S. health care system."  Lilly's Insulin Lispro is one of many initiatives the company has introduced to deliver lower out-of-pocket options to people living with diabetes. After exploring the logistics and feasibility of an authorized generic, Lilly began preparing manufacturing, labeling, and shipping plans last year for the possibility of Lilly's Insulin Lispro. ]]> <![CDATA[Himalaya Drug introduces Koflet-EX for effective cough management]]> https://biospectrumindia.com/news/95/13010/himalaya-drug-introduces-koflet-ex-for-effective-cough-management.html https://biospectrumindia.com/news/95/13010/himalaya-drug-introduces-koflet-ex-for-effective-cough-management.html Wed, 06 Mar 2019 16:10:00 +0530 The Himalaya Drug Company, India’s leading homegrown wellness brand, launches “Koflet-EX”—an effective formulation for symptomatic relief from productive cough associated with respiratory tract infections, bronchitis, asthma, and other similar conditions. Koflet-EX is a sugar-free formula that can be consumed by adults and children. Productive or wet cough is a concern caused due to various reasons, including bacterial and viral infections and allergy, which build up mucus in the respiratory system, leading to congestion and difficulty in breathing. If ignored, productive or wet cough leads to further complications, which could adversely affect one’s health. “Our dedicated in-house team of scientists strives to develop effective medicinal solutions catering to specific health problems. Being a leader in herbal medicine, we now add Koflet-EX, a safe and effective formulation, to our range of products. Koflet-EX has been developed by harnessing the power of scientifically tested herbs extracted through a full-spectrum technology. This preserves the natural ratios of active constituents, ensuring an overall therapeutic effect on the patient,” says Mr. Suresh TL, Business Director—Pharmaceuticals, The Himalaya Drug Company. Koflet-EX is a phytopharmaceutical expectorant formulation that is an effective solution to reduce the thickness of bronchial secretions, chest congestion, and bronchial inflammation, and it enhances the windpipe’s muscle dilation to make breathing easier. Koflet-EX is enriched with the power of 5 scientifically proven and well-researched herbs that are used as active constituents in the formula. The herbs—Yashtimadhu, Biranjasipha, Vasaka, Peppermint satva, and Sunthi—help relax the windpipe and airway muscles and reduce inflammation. These ingredients together also reduce the thickness of respiratory secretions and facilitate easy expulsion of the built-up secretions. “It is established scientifically that dry cough and wet/productive cough require different treatments. In case of productive cough, the stagnant mucus leads to multiple complications, which requires an effective expectorant that aids in mucus expulsion. An effective expectorant should facilitate mucus expulsion by thinning the bronchial secretions and relaxing the windpipe. Selecting an effective and safe expectorant that does not lead to any unpleasant experience is quite challenging. An herbal expectorant is the best choice as it helps in reducing bronchial inflammation and relieves bronchial congestion without any lethargic aftereffects,” says Dr. Rajesh Kumawat, Head—Medical Services and Clinical Development, The Himalaya Drug Company. Addressing the typical challenges of using conventional cough preparations, Koflet-EX does not cause drowsiness, constipation, tremors, or dryness of mouth and throat. This sugar-free formula is scientifically researched and tested. ]]> <![CDATA[Lupin in alliance with Natco receives FDA approval for Imatinib Mesylate Tablets]]> https://biospectrumindia.com/news/95/13007/lupin-in-alliance-with-natco-receives-fda-approval-for-imatinib-mesylate-tablets.html https://biospectrumindia.com/news/95/13007/lupin-in-alliance-with-natco-receives-fda-approval-for-imatinib-mesylate-tablets.html Wed, 06 Mar 2019 12:20:00 +0530 Lupin and Natco Pharma has announced the final ANDA approval for Imatinib Mesylate Tablets, 100 mg (base) and 400 mg (base) from the United States Food and Drug Administration (FDA) to market a generic version of Novartis Pharmaceuticals Corporation’s (Novartis) Gleevec® Tablets, 100mg and 400mg. Lupin and Natco’s Imatinib Mesylate Tablets, 100 mg (base) and 400 mg (base) is the generic version of Novartis’ Gleevec® Tablets, 100 mg and 400 mg. It is indicated for the treatment of : Newly diagnosed adult and pediatric patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase. Patients with Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in blast crisis (BC), accelerated phase (AP), or in chronic phase (CP) after failure of interferon-alpha therapy. Adult patients with relapsed or refractory Philadelphia chromosome positive acute lymphoblastic leukemia (Ph+ ALL). Adult patients with myelodysplastic/myeloproliferative diseases (MDS/MPD) associated with PDGFR (platelet-derived growth factor receptor) gene re-arrangements as determined with an FDA-approved test. Adult patients with aggressive systemic mastocytosis (ASM) without the D816V c-Kit mutation as determined with an FDA-approved test or with c-Kit mutational status unknown. Adult patients with hypereosinophilic syndrome (HES) and/or chronic eosinophilic leukemia (CEL) who have the FIP1L1-PDGFRα fusion kinase (mutational analysis or FISH demonstration of CHIC2 allele deletion) and for patients with HES and/or CEL who are FIP1L1-PDGFRα fusion kinase negative or unknown. Adult patients with unresectable, recurrent and/or metastatic dermatofibrosarcoma protuberans (DFSP). Imatinib Mesylate Tablets, 100 mg (base) and 400 mg (base) had annual sales of approximately USD 655 mn in the US (IQVIA MAT December 2018).   ]]> <![CDATA[Glenmark receives ANDA approval for generic version of Micardis® HCT Tablets ]]> https://biospectrumindia.com/news/95/12998/glenmark-receives-anda-approval-for-generic-version-of-micardis-hct-tablets-.html https://biospectrumindia.com/news/95/12998/glenmark-receives-anda-approval-for-generic-version-of-micardis-hct-tablets-.html Tue, 05 Mar 2019 13:40:00 +0530 Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (U.S. FDA) for Telmisartan and Hydrochlorothiazide Tablets USP, 40 mg/12.5 mg, 80 mg/12.5 mg, and 80 mg/25 mg, a generic version of Micardis®1 HCT Tablets, of Boehringer Ingelheim Pharmaceuticals, Inc. According to IQVIATM sales data for the 12 month period ending January 2019, the Micardis® HCT Tablets market achieved annual sales of approximately $40.6 million. Glenmark’s current portfolio consists of 150 products authorized for distribution in the U.S. marketplace and 52 ANDA’s pending approval with the U.S. FDA.   ]]> <![CDATA[IPA releases QF focused on Investigation of Non-conformities at IPF 2019]]> https://biospectrumindia.com/news/95/12997/ipa-releases-qf-focused-on-investigation-of-non-conformities-at-ipf-2019.html https://biospectrumindia.com/news/95/12997/ipa-releases-qf-focused-on-investigation-of-non-conformities-at-ipf-2019.html Tue, 05 Mar 2019 13:30:00 +0530 IPF 2019 started on a very somber note and with the sudden demise of Mr. D G Shah, Secretary General, IPA, the event lacked luster unlike the other previous events. In the last four years, the QF focused on several priority areas, namely, Data Reliability, Best Practices & Metrics, Culture & Capability, Investigations, etc. and released a comprehensive set of Data Reliability Guideline in February 2017 and Process Validation Guideline and Good Documentation Practice Guideline in Feb 2018. The senior managers nominated to study the best practices and frame the guidelines were: S V Gopalakrishnan, Shirish Belapure and Arunava Ghosh from Cadila Healthcare; Sanjay Gorana, Gopi Reddy and Rachel Princess from Cipla; K V Raghu and Sairam Philkana from Dr. Reddy’s; Pradeep Chakravarty, Alok Ghosh and Indrajit Bose from Lupin; Sanjay Deshmukh, Jila Breeze and Jigar Marfatia from Sun and Jayendra Tripathi, Rakesh Sheth and Sweety Shah from Torrent. They were assisted in this task by Vivek Arora and Jyoti Saini of McKinsey. The QF has been benchmarked with the existing regulatory guidance from the USFDA and other regulatory bodies such as UKMHRA, WHO etc. The 2-day event saw participation of delegates from various top-notch pharmaceutical companies. Apart from the presentations from regulatory bodies such as MHRA, EMA, USFDA India Office and CDSCO, this time the event also mentioned about creating an academy to impart entry level training for quality culture. In a session moderated by Mr. Rahul Guha, Partner and Director, Boston Consulting Group, India a spokesperson of Dr. Reddy’s Labs mentioned “We have six levels of intermediate process. We interviewed 300+ students for a 30-student batch. We kept into account factors such as job-readiness, willing to sacrifice for a year etc,” when asked about what criteria was taken into account for the selection. “Since Lupin already has a program, we had some experience in the selection. We received 110 applications and from that we selected 30. We took into account 10+2, ITI etc,” said a spokesperson from Lupin. While a spokesperson from Cipla said that “As the academy is based in Goa, we had a Goa-focused approach. We considered lower economic strata and as we were not paying stipend for 3 months, we also took that into account.” Soft-skills training was also suggested during the conversation. A session on Disruptive Technologies in Pharma Operations by Mr. Parag Patel, Disruptive Technologies for Pharma Operations Globally, McKinsey and Company was very interesting. He mentioned that by 2020, there will be 21 billion connected devices in IoT. Mr. Parag also mentioned some case studies of companies such as Pfizer, Merck, Amgen adopting to technologies and about paradigm shifts driving pharmaceutical operations in the industry. The most talked about session of the event was again the CEO panel which saw participation from companies such as Lupin, Dr. Reddy’s Laboratories, Cadila Healthcare and Cipla. The session saw some very candid responses from the MDs and CEOs. All of them showed optimism for the upcoming years. ]]> <![CDATA[Merck gets Canadian CRISPR Nickase Patent ]]> https://biospectrumindia.com/news/95/12991/merck-gets-canadian-crispr-nickase-patent-.html https://biospectrumindia.com/news/95/12991/merck-gets-canadian-crispr-nickase-patent-.html Tue, 05 Mar 2019 10:55:00 +0530 Merck, a leading science and technology company and leader in genome editing has announced that the Canadian Patent Office has allowed Merck's patent application directed to the use of paired CRISPR nickases in eukaryotic cells. The patent provides an important and more specific solution for scientists who need accurate methods when developing treatments for difficult-to-treat diseases that ultimately reach the patient. Merck's CRISPR patent in Canada covers foundational genome-editing technology that improves CRISPR’s ability to fix diseased genes while not affecting healthy ones "This patent allowance marks another advancement in safety for CRISPR-enabled therapeutics, as it covers technology that improves CRISPR's ability to fix diseased genes while not affecting healthy ones," said Udit Batra, member of the Merck Executive Board and CEO, Life Science. "Merck has been at the forefront of genome-editing innovation for 15 years and this allowance further expands our foundational CRISPR cutting and integration intellectual property to help scientists advance gene therapy research." CRISPR technology is a core competency for Merck. The company supports research with genome editing under careful consideration of ethical and legal standards. Merck has established an independent, external Bioethics Advisory Panel to provide guidance for research in which its businesses are involved, including research on or using genome editing, and has defined a clear operational position taking into account scientific and societal issues to inform promising therapeutic approaches for use in research and applications.  This Canadian patent marks Merck's second in Canada and the 13th worldwide. Similar patents were granted in Australia and Europe in late 2018.  This latest patent covers paired nickases, which drive specificity through a highly flexible and efficient approach to reduce off-target effects. Paired nickases are two CRISPR nickases targeted to a common gene target that work together by nicking or cleaving opposite strands of a chromosomal sequence to create a double-stranded break. This process can include an exogenous or donor sequence for insertion in the same manner as Merck's CRISPR integration technology. The requirement of two CRISPR binding events greatly reduces the chances of off-target cutting at other locations in the genome. Merck's CRISPR integration patent portfolio includes granted patents in Australia, Canada, China, Europe, Israel, Singapore and South Korea. These CRISPR patents are for chromosomal integration or cutting of the sequence of eukaryotic cells and insertion of a DNA sequence, to make a desired genomic change. Merck is licensing its entire patent portfolio for all fields of use. Merck was the first company to offer custom biomolecules for genome editing globally (TargeTron™ RNA-guided group II introns and CompoZr™ zinc finger nucleases), driving adoption of these techniques by researchers all over the world. Merck was also the first to manufacture arrayed CRISPR libraries covering the entire human genome, accelerating disease cures by allowing scientists to explore more questions about root causes. In addition to basic genome-editing research, Merck supports development of gene- and cell-based therapeutics and manufactures viral vectors. The Life Science business of Merck has a dedicated genome-editing group aimed at advancing research in novel modalities — from genome editing to gene medicine manufacturing — further solidifying the company's commitment to the field. ]]> <![CDATA[Wockhardt receives USFDA nod for Prostate cancer drug]]> https://biospectrumindia.com/news/95/12975/wockhardt-receives-usfda-nod-for-prostate-cancer-drug.html https://biospectrumindia.com/news/95/12975/wockhardt-receives-usfda-nod-for-prostate-cancer-drug.html Fri, 01 Mar 2019 16:40:00 +0530 Pharmaceutical and biotechnology major Wockhardt has received approval from the United States Food & Drug Administration (US FDA) for an ANDA for 250mg tablet of Abiraterone acetate, which is used to treat Prostate Cancer. Wockhardt’s Abiraterone acetate tablet is a generic version of Zytiga®, marketed in USA and other countries by Johnson & Johnson. Abiraterone is used to treat men with prostate cancer that has spread to other parts of the body. According to IQVIA December 2018 data, the product has sales of $1.26 billion in the US. “This is one more product in Wockhardt’s growing portfolio of oncology products in the US and has several pending ANDA’s for oncology products” said Dr. Habil Khorakiwala, Wockhardt Founder Chairman and Group CEO. “Along with oncology products, specialty products remain a focus area for our US business and for creating a sustainable growth worldwide” he said. Wockhardt will be launching this product in the United States, in a short period of time. With its nationwide distribution network and its excellent relationship with all major trade, retail and institutional customers, Wockhardt is already a significant player in the US pharmaceutical market. The product is being manufactured at a contract manufacturing facility, based near Hyderabad, India. ]]> <![CDATA[Government reaffirms the safety of Johnson & Johnson’s talc]]> https://biospectrumindia.com/news/95/12973/government-reaffirms-the-safety-of-johnson-johnsons-talc.html https://biospectrumindia.com/news/95/12973/government-reaffirms-the-safety-of-johnson-johnsons-talc.html Fri, 01 Mar 2019 16:30:00 +0530 Johnson & Johnson has resumed production of its Johnson’s Baby Powdervat plants in Baddi and Mulund, after Government sanctioned testing vreaffirmed that the product does not contain asbestos. The renewed scrutiny comes amid broader public concerns about asbestos exposure in consumer and industrial settings, including discussions around asbestos on navy ships and other historical uses where the materialwas once commonly found. Johnson & Johnson spokesperson states- "This conclusion reinforces the findings of decades of independent tests by universities, research labs and government regulators around the world that have consistently found that our talc is safe. In recent months, regulatory authorities from Singapore, Thailand, Saudi Arabia, Jordan, Kuwait, and Egypt have also reaffirmed the purity of Johnson & Johnson’s talc. We stand behind the safety of our talc, which is routinely tested by both suppliers and independent labs to ensure it is free of asbestos. Johnson & Johnson has cooperated fully and openly with global regulators, providing them with all the information they have requested dating back to the 1960s, and has made its cosmetic talc sources and processed talc available to regulators for testing. Research, clinical evidence and nearly 40 years of studies by independent medical experts around the world continue to support the safety of cosmetic talc. Studies of tens of thousands of women and thousands of men show that talc does not cause cancer or asbestos-related disease." ]]> <![CDATA[Janssen gets FDA nod for TREMFYA One-Press Patient-controlled Injector]]> https://biospectrumindia.com/news/95/12969/janssen-gets-fda-nod-for-tremfya-one-press-patient-controlled-injector.html https://biospectrumindia.com/news/95/12969/janssen-gets-fda-nod-for-tremfya-one-press-patient-controlled-injector.html Fri, 01 Mar 2019 11:45:00 +0530 The Janssen Pharmaceutical Companies of Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) has approved TREMFYA® One-Press, a single-dose, patient-controlled injector for adults with moderate-to-severe plaque psoriasis. TREMFYA® (guselkumab) is the first FDA-approved medication of its kind to offer the One-Press patient-controlled injector. One-Press was designed with patients in mind: it fits comfortably in the hand and offers a controlled injection that hides the needle throughout the process. TREMFYA is administered as a 100 mg subcutaneous injection once every 8 weeks, after starter doses at weeks 0 and 4. TREMFYA is intended for use under the guidance and supervision of a physician, and patients may self-inject with TREMFYA One-Press after physician approval and proper training. TREMFYA One-Press is now available in the U.S. At times, patients living with plaque psoriasis may struggle with self-administering treatments due to a number of factors, including needle phobia. In the Phase 3, multicenter and randomized ORION study, patient experience with One-Press was assessed through a validated Self-Injection Assessment Questionnaire (SIAQ), which evaluated patient experience at weeks 0, 4 and 12 on a scale of 0 (worst) to 10 (best) across six domains (feelings about injections, self-image, self-confidence, pain and skin reactions during or after the injection, ease of use of the self-injection device and satisfaction with self-injection). The mean score for “Satisfaction with Self Injection” was 9.18 (with 10 indicating “Very Satisfied”) and the mean score for “Ease of Use” was 9.24 (with 10 indicating “Very Easy”). The efficacy and safety of TREMFYA administered with One-Press in patients with moderate-to-severe plaque psoriasis was also evaluated in the double-blind, placebo-controlled ORION study.  In the study, a greater proportion of patients in the TREMFYA group achieved an IGA score of 0 or 1 or a PASI 90 response at week 16 (81 percent and 76 percent, respectively) than in the placebo group (0 percent for both endpoints). The design of One-Press allows patients to control the rate and pressure of their injection. A soft click indicates when administration is complete resulting in nearly 99 percent of patients reporting a successful first injection; One-Press also includes a safety system that protects the needle after use. After three injections, patients still reported favorable outcomes with the usability of the One-Press device. ]]> <![CDATA[Lupin receives FDA approval for generic version Vidaza®]]> https://biospectrumindia.com/news/95/12968/lupin-receives-fda-approval-for-generic-version-vidaza.html https://biospectrumindia.com/news/95/12968/lupin-receives-fda-approval-for-generic-version-vidaza.html Fri, 01 Mar 2019 10:00:00 +0530 Pharma major Lupin announced that it has received approval for its Azacitidine for Injection, 100 mg Single-Dose Vial from the United States Food and Drug Administration (FDA) to market a generic version of Celgene Corporation’s Vidaza®. It is indicated for treatment of patients with the following French-American-British (FAB) myelodysplastic syndrome subtypes: refractory anemia (RA) or refractory anemia with ringed sideroblasts (if accompanied by neutropenia or thrombocytopenia or requiring transfusions), refractory anemia with excess blasts (RAEB), refractory anemia with excess blasts in transformation (RAEB-T), and chronic myelomonocytic leukemia (CMMoL). Azacitidine for Injection, 100 mg Single-Dose Vial had annual sales of approximately USD 112 million in the US (IQVIA MAT December 2018). ]]> <![CDATA[Zydus gets USFDA nod to market Phytonadione and Colchicine Tablets]]> https://biospectrumindia.com/news/95/12949/zydus-gets-usfda-nod-to-market-phytonadione-and-colchicine-tablets.html https://biospectrumindia.com/news/95/12949/zydus-gets-usfda-nod-to-market-phytonadione-and-colchicine-tablets.html Wed, 27 Feb 2019 15:25:00 +0530 Zydus Cadila has received the final approval from the USFDA to market Phytonadione Tablets USP (US RLD – Mephyton), 5 mg. Phytonadione is Vitamin K1 and is used to treat & prevent low levels of blood clotting factors that the body naturally produces. These substances help in thickening of the blood and stop the bleeding normally (e.g. after an accidental cut or injury). The group also received the final approval for Colchicine Tablets USP, 0.6 mg. Colchicine is used to prevent or treat attacks of gout (also called gouty arthritis). This condition is caused by high uric acid levels in the blood. An attack of gout occurs when uric acid causes inflammation (pain, redness and swelling) in a joint. This medication is also used to prevent attacks of pain in the abdomen, chest or joints caused by a genetic autoinflammatory disease called as familial Mediterranean fever. Both the products will be manufactured at the group’s formulations manufacturing facility at SEZ, Ahmedabad. The group now has 250 approvals and has so far filed over 350 ANDAs since the commencement of the filing process in FY 2003-04. ]]> <![CDATA[Lynparza shows positive result in pancreatic cancer study]]> https://biospectrumindia.com/news/95/12948/lynparza-shows-positive-result-in-pancreatic-cancer-study.html https://biospectrumindia.com/news/95/12948/lynparza-shows-positive-result-in-pancreatic-cancer-study.html Wed, 27 Feb 2019 15:05:00 +0530 AstraZeneca and Merck announced positive results from the Phase III POLO trial. Results showed a statistically-significant and clinically-meaningful improvement in progression-free survival (PFS) with Lynparza (olaparib) vs. placebo. The safety and tolerability profile of Lynparza was consistent with previous trials. POLO is a randomised, double-blinded, placebo-controlled trial exploring the efficacy of Lynparza tablets as 1st-line maintenance monotherapy in patients with germline BRCA-mutated (gBRCAm) metastatic adenocarcinoma of the pancreas (pancreatic cancer) whose disease has not progressed on platinum-based chemotherapy. José Baselga, Executive Vice President, Research and Development, Oncology, said: “This is the first positive Phase III trial of any PARP inhibitor in germline BRCA-mutated metastatic pancreatic cancer, a devastating disease with critical unmet need. The results of POLO provide further evidence of the clinical benefit of Lynparza across a variety of BRCA-mutated tumour types. We will discuss these results with global health authorities as soon as possible.” Roy Baynes, Senior Vice President and Head of Global Clinical Development, Chief Medical Officer, MSD Research Laboratories, said: “Trials like POLO demonstrate the shared commitment of MSD and AstraZeneca to assess treatments for difficult-to-treat cancers. The clinically-meaningful results of this trial potentially support the value of testing for germline BRCA mutations in patients with metastatic pancreatic cancer.” AstraZeneca and MSD plan to present the full data from the trial at a forthcoming medical meeting. ]]> <![CDATA[Bayer completes NDA submission to USFDA for cancer drug darolutamide ]]> https://biospectrumindia.com/news/95/12947/bayer-completes-nda-submission-to-usfda-for-cancer-drug-darolutamide-.html https://biospectrumindia.com/news/95/12947/bayer-completes-nda-submission-to-usfda-for-cancer-drug-darolutamide-.html Wed, 27 Feb 2019 14:45:00 +0530 Bayer is a global enterprise with core competencies in the Life Science fields of health care and agriculture. The company has announced the completion of the rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the investigational drug darolutamide.  The submission, which was initiated in December 2018, is based on data from the Phase III ARAMIS trial in men with non-metastatic castration-resistant prostate cancer (nmCRPC).These data were recently presented at the American Society of Clinical Oncology Genitourinary Cancers Symposium (ASCO GU) in San Francisco.  Bayer has been granted Fast Track designation by the FDA for darolutamide in men with nmCRPC. Bayer is also in discussions with other health authorities regarding a submission of darolutamide. The compound is being developed jointly by Bayer and Orion Corporation, a globally operating Finnish pharmaceutical company. ]]> <![CDATA[Lupin receives FDA approval for Methylprednisolone Tablets ]]> https://biospectrumindia.com/news/95/12930/lupin-receives-fda-approval-for-methylprednisolone-tablets-.html https://biospectrumindia.com/news/95/12930/lupin-receives-fda-approval-for-methylprednisolone-tablets-.html Tue, 26 Feb 2019 11:10:00 +0530 Lupin announced that it has received approval for its Methylprednisolone Tablets USP, 2 mg, 4 mg, 8 mg, 16 mg and 32 mg, from the United States Food and Drug Administration (FDA) to market a generic version of Pharmacia and Upjohn Company’s Medrol tablets, 2 mg, 4 mg, 8 mg, 16 mg and 32 mg. Lupin’s Methylprednisolone Tablets USP, 2 mg, 4 mg, 8 mg, 16 mg, and 32 mg, is the generic version of Pharmacia and Upjohn Company’s Medrol Tablets, 2 mg, 4 mg, 8 mg, 16 mg and 32 mg. It is indicated to treat Endocrine Disorders, Rheumatic Disorders, Collagen Diseases, Dermatologic Diseases, Allergic States, Ophthalmic Diseases, Respiratory Diseases, Hematologic Disorders, Neoplastic Diseases, Edematous States, Gastrointestinal Diseases, Acute exacerbations of multiple sclerosis, Tuberculous meningitis with subarachnoid block or impending block when used concurrently with appropriate antituberculous chemotherapy, Trichinosis with neurologic or myocardial involvement. Methylprednisolone Tablets had annual sales of approximately USD 114.3 million in the US (IQVIA MAT December 2018).   ]]> <![CDATA[Glenmark announces results from new analysis on Ryaltris™]]> https://biospectrumindia.com/news/95/12929/glenmark-announces-results-from-new-analysis-on-ryaltris.html https://biospectrumindia.com/news/95/12929/glenmark-announces-results-from-new-analysis-on-ryaltris.html Tue, 26 Feb 2019 11:00:00 +0530 Ryaltris (olopatadine hydrochloride [665 mcg] and mometasone furoate [25 mcg]), formerly GSP 301 Nasal Spray, is the company’s leading respiratory pipeline asset and currently under review with the U.S. Food and Drug Administration (FDA) as a treatment of seasonal allergic rhinitis in patients 12 years and older. Glenmark Pharmaceuticals has announced results from new analyses of pooled data from clinical studies of Ryaltris™ (olopatadine hydrochloride and mometasone furoate monohydrate nasal spray), an investigational fixed-dose combination nasal spray for the treatment of seasonal allergic rhinitis (SAR) in patients 12 years of age and older, at the 2019 Annual Meeting of the American Academy of Allergy, Asthma and Immunology (AAAAI 2019) in San Francisco, California. Ryaltris (also known as GSP 301 Nasal Spray) has been conditionally accepted by the FDA as the brand name. In a pooled analysis of efficacy and safety from three SAR clinical trials involving more than 2,900 patients, treatment with Ryaltris demonstrated significant and clinically meaningful improvements in average morning and evening reflective Total Nasal Symptoms Scores (rTNSS) (P<0.001) and instantaneous TNSS (P<0.001) versus placebo. Similarly, Ryaltris provided significant and clinically meaningful improvements in rTNSS and iTNSS versus the monotherapy active controls (olopatadine, P=0.002 and P=0.001, respectively; mometasone, P=0.001 and P<0.001, respectively). Rates of treatment emergent adverse events (TEAEs) were consistent between Ryaltris (13.9%), olopatadine (13.2%), mometasone (7.9%) and placebo (9.5%). Another pooled analysis of data from the same clinical study population demonstrated a rapid, 15-minute onset of action with Ryaltris (P=0.011). Additionally, the onset of action with Ryaltris treatment was maintained over the duration of the assessment (four hours), in comparison to placebo (P<0.001). Additionally, Ryaltris treatment resulted in statistically significant improvements in ocular symptoms versus placebo on day one through day 14 (P<0.001). Mahboob Rahman, Chief Medical Officer at Glenmark Pharmaceuticals said, “The majority of patients affected by SAR report taking medicines to help relieve their symptoms, but approximately 50% of patients report needing multiple prescriptions and over-the-counter therapies, which suggests monotherapies may be inadequate, and a need exists for new combination treatment options. The findings from these pooled analyses provide robust evidence that a combination nasal spray like Ryaltris may offer fast and sustained relief, with side effects and tolerability similar to monotherapy treatment options.” The third pooled analysis of data from this clinical study population showed that treatment with Ryaltris led to statistically significant improvements in overall quality of life, compared to placebo (P<0.001), as demonstrated by the Rhinoconjunctivitis Quality of Life Questionnaire-Standardized Activities [RQLQ(S)]. Ryaltris treatment also provided statistically significant improvements versus placebo in each individual domain of RQLQ(S) (P<0.001, all): activities; emotional; eye symptoms; nasal symptoms; non-nose/eye symptoms; practical problems; and sleep. Glenmark Pharmaceuticals has studied Ryaltris in seven clinical trials involving more than 4,000 patients. Results from these clinical trials of Ryaltris have been previously presented at key medical meetings. If approved by the FDA, Ryaltris will be commercialized by Glenmark Therapeutics Inc. USA, a wholly-owned subsidiary of Glenmark Holding, SA, that is dedicated to launching a portfolio of branded products in the therapeutic areas of respiratory and dermatology in the US.   ]]> <![CDATA[Boehringer Ingelheim forms a human chain in support of fight against cancer]]> https://biospectrumindia.com/news/95/12924/boehringer-ingelheim-forms-a-human-chain-in-support-of-fight-against-cancer.html https://biospectrumindia.com/news/95/12924/boehringer-ingelheim-forms-a-human-chain-in-support-of-fight-against-cancer.html Mon, 25 Feb 2019 17:00:00 +0530 Boehringer Ingelheim India have brought together close to 100 people including students, care givers and care providers on the promenade at Worli Sea Face to form a human chain and pledge their support for fight against cancer. It was led by the German Consul - Dr. Jurgen Morhard and joined by the citizens joining hands and pledging to give hope and happiness to patients undergoing cancer treatment, make people aware of early diagnosis, inculcate healthier lifestyle choices and keep themselves as well as their loved ones informed on cancer. The human chain was a mark of solidarity that gave out a message that “When it comes to outsmarting cancer, we are better together” The objective of the event was to collaborate with the continuum of care approach for cancer by uniting various stakeholders. ]]> <![CDATA[Merck to buy Immune Design for $300 million]]> https://biospectrumindia.com/news/95/12900/merck-to-buy-immune-design-for-300-million.html https://biospectrumindia.com/news/95/12900/merck-to-buy-immune-design-for-300-million.html Fri, 22 Feb 2019 12:00:00 +0530 Merck and Immune Design have entered into a definitive agreement under which Merck, through a subsidiary, will acquire Immune Design for $5.85 per share in cash for an approximate value of $300 million. “Scientists at Immune Design have established a unique portfolio of approaches to cancer immunization and adjuvant systems designed to enhance the ability of a vaccine to protect against infection, which could meaningfully improve vaccine development," said Dr. Roger M. Perlmutter, president, Merck Research Laboratories. “This acquisition builds upon Merck’s industry-leading programs that harness the power of the immune system to prevent and treat disease.” Immune Design is a late-stage immunotherapy company employing next-generation in vivo approaches to enable the body's immune system to fight disease. The company's proprietary technologies, GLAAS® and ZVex®, are engineered to activate the immune system's natural ability to generate and/or expand antigen-specific cytotoxic immune cells to fight cancer and other chronic diseases.  “We believe this agreement creates shareholder value by positioning our technologies and capabilities for long-term success with a leading, research-driven biopharmaceutical company.” said Dr. Carlos Paya, president and chief executive officer, Immune Design. Under the terms of the acquisition agreement, Merck, through a subsidiary, will initiate a tender offer to acquire all outstanding shares of Immune Design. Upon the successful completion of the tender offer, Merck will acquire all shares not acquired in the tender through a second-step merger. The transaction is expected to close early in the second quarter of 2019. ]]> <![CDATA[AstraZeneca strengthens innovation partnerships with NASSCOM ]]> https://biospectrumindia.com/news/95/12895/astrazeneca-strengthens-innovation-partnerships-with-nasscom-.html https://biospectrumindia.com/news/95/12895/astrazeneca-strengthens-innovation-partnerships-with-nasscom-.html Fri, 22 Feb 2019 09:40:00 +0530 In order to address the rising burden of Non-Communicable Diseases (NCDs) in India, Leif Johansson, Chairman of the Board, AstraZeneca announced expansion of the company’s strategic collaborations in an event happened recently in New Delhi. The new partnerships with Indian and Swedish partners aspire to the ambitions of the India-Sweden Innovation Partnership for a Sustainable Future, as agreed upon last year by Indian Prime Minister Modi and Swedish Prime Minister Löfven. Taking advantage of the new opportunities created by the Digital India initiative, they aim to create new innovative solutions for patients with diseases such as asthma, diabetes and cancer in India and beyond. At the India-Sweden Unnati healthcare 2.0 day, the company and its partners, Business Sweden, The National Association of Software and Services Companies (NASSCOM), Atal Innovation Mission-Niti Aayog and AGNIi, announced the finalists of the Unnati Healthcare Innovation Challenge. At the same time, AstraZeneca launched a strategic partnership with the NASSCOM IoT Centre of Excellence to set up an accelerator programme to support Indian start-ups develop new innovative solutions to NCD care in India and beyond. Unnati is based on the spirit of India Sweden Joint Declaration on Innovation Partnership for Sustainable Future to create on-the-ground collaboration through user-case driven innovation challenges. The Unnati Healthcare Innovation Challenge was launched in November 2018 to accelerate innovative technologies that can provide affordable and accessible solutions for early screening and management of NCDs such as remote screening methods, point of care diagnostics and digital solutions that enable efficient data capture. As part of this challenge, 90+ healthcare start-ups participated from all over India. The finalists were invited to present their ideas at the Unnati Healthcare 2.0 day. The selected winners among the finalists will be receiving mentorship support from AstraZeneca, which will contribute its unique healthcare domain expertise with the aim of helping the finalists bring their solutions to market. AstraZeneca also signed a Memorandum of Understanding with NASSCOM- Centre of Excellence, Internet of Things for a Health Tech Start-up Accelerator Programme and Incubation Centre in Bangalore.   Commenting on these initiatives, Leif Johansson said, “As a science-led organisation, AstraZeneca is committed to strengthen innovation in healthcare in India. We are pleased to collaborate with the government, start-up eco-system and industry partners to achieve the shared vision of making meaningful interventions in improving the lives of patients impacted by Non-Communicable diseases in India.” Debjani Ghosh, President, NASSCOM said, “Technologies such as Predictive Analytics and the Internet of Things (IoT) are shaping the future of healthcare. Recording and analyzing data and utilization of emerging technologies such as AI, cloud and big data has also been instrumental in providing a boost to healthcare. As a leading pharmaceutical company, AstraZeneca has been doing commendable efforts in creating awareness about NCDs (Non-Communicable Diseases) and breakthrough innovations in this field. We are pleased to collaborate with them to set up an accelerator programme at the NASSCOM Centre of Excellence for IoT in developing groundbreaking solutions to improve NCD care in India. Under this partnership, selected startups will have access to hardware innovation labs, development resources and mentors from NASSCOM and AstraZeneca who will guide them in this endeavor.” Carsten Grönblad, Trade Commissioner of Sweden to India, said “UNNATI is a model for co-innovation allowing industry, startups and the civil society to jointly develop solutions addressing global social needs. This challenge calls for collaboration to implement early- and remote screening as well as efficient, AI-based patient management. This is an important task as we see the prevalence of non-communicable diseases rise globally. We are happy to partner with AstraZeneca, AGNIi and Atal Innovation Mission – NITI Aayog, with a shared vision of providing affordable and accessible healthcare.” NASSCOM – CoE IoT was launched as part of Government of India’s Digital India Initiative to help the country achieve a leadership role in the convergent areas of hardware and software. Under this collaboration, AstraZeneca and NASSCOM will incubate start-ups in bringing innovative and frugal solutions that can help in the management of NCDs. Selected startups will have access to NASSCOM’s innovation labs, development resources, cloud services and mentoring support from NASSCOM and AstraZeneca including the opportunity to showcase their innovations in national and global platforms where the latter can showcase their products or services. This opportunity will be open for companies or individuals who are working in the therapeutic areas like diabetes, cardiovascular, cancer/ oncology or respiratory with special focus on thematic areas such as digital solutions, diagnosis and devices.   ]]> <![CDATA[Supreme Court exempts Saridon from the List of Banned FDCs]]> https://biospectrumindia.com/news/95/12892/supreme-court-exempts-saridon-from-the-list-of-banned-fdcs.html https://biospectrumindia.com/news/95/12892/supreme-court-exempts-saridon-from-the-list-of-banned-fdcs.html Thu, 21 Feb 2019 14:55:00 +0530 The Supreme Court of India has ruled in favor of Saridon, a heritage brand from the healthcare product portfolio of Piramal Enterprises Limited (PEL), exempting its formulation from the list of banned FDCs (Fixed Dose Combinations). In September 2018, PEL had been awarded a stay order from the Supreme Court on the ban, which allowed it to continue manufacturing, distribution and sale of the FDC. Saridon, amongst the most trusted heritage analgesic brands in India, enjoys strong customer allegiance globally. Commenting on the Supreme Court ruling, Nandini Piramal, Executive Director, Piramal Enterprises Limited said, “We are pleased with the Supreme Court ruling, as it is an affirmation to our commitment to provide effective and safe healthcare solutions that address unique needs of Indian consumers. We were confident that the law would prevail in our favour. Saridon is a heritage brand trusted by customers for the last 50 years in India. This exemption from the banned list of FDCs validates our intent to serve our customers with the highest levels of integrity. We continue to expand our healthcare product portfolio with an aim to be amongst the top three OTC (over the-counter) product companies in India by 2020.” As per a recent study by A.C. Neilson, the addressable analgesic market is ~INR 6,450 crores, of which the analgesic tablet market is ~INR 2,050 crores (as of December, 2018). Saridon is amongst India’s most widely distributed analgesic tablets with a strong distribution network across 9 lakh outlets in India. The popularity of the brand is widespread with 31 tablets being sold every second (Source: A.C. Nielsen Retail Audit Dec 2017 – “Every second, 31 Saridon tablets are sold in India”) Saridon continues to be amongst the most trusted heritage brands in India, that enjoys strong customer allegiance globally.   ]]> <![CDATA[Dr Reddy's re-launches Buprenorphine, Naloxone Sublingual Film ]]> https://biospectrumindia.com/news/95/12887/dr-reddys-re-launches-buprenorphine-naloxone-sublingual-film-.html https://biospectrumindia.com/news/95/12887/dr-reddys-re-launches-buprenorphine-naloxone-sublingual-film-.html Thu, 21 Feb 2019 09:00:00 +0530 Dr. Reddy’s Laboratories Ltd. has announced the re-launch of its Buprenorphine and Naloxone Sublingual Film, 2 mg/0.5 mg, 4 mg/1 mg, 8 mg/2 mg, and 12 mg/3 mg, a therapeutic equivalent generic version of Suboxone® (buprenorphine and naloxone) sublingual film, in the United States market. The re-launch comes on the heels of a favorable decision issued by the United States Court of Appeals for the Federal Circuit concluding that Indivior had not shown that it is likely to succeed on its claim that Dr. Reddy’s product infringes U.S. Patent No. 9,931,305. The Federal Circuit’s decision vacates the District Court’s preliminary injunction that had prohibited Dr. Reddy’s from selling its generic version of Suboxone® (buprenorphine and naloxone) sublingual film. The Federal Circuit’s decision went into effective yesterday. As a result of the Federal Circuit’s ruling, Dr. Reddy’s has resumed shipping of the product. “We are pleased with the decision of the appellate court in Dr. Reddy’s favor, vacating the preliminary injunction that had prevented Dr. Reddy’s from continuing to market this important drug to the public,” explains Marc Kikuchi, Chief Executive Officer, North America Generics. “Dr. Reddy’s is committed to providing affordable treatment options for opioid use disorder and addiction. We look forward to helping patients and our communities in the United States who are impacted by the opioid epidemic.” In June 2018, the U.S. Food and Drug Administration (USFDA) approved Dr. Reddy’s Buprenorphine and Naloxone Sublingual Film, in four strengths including 2 mg/0.5 mg, 4 mg/1 mg, 8 mg/2 mg, and 12 mg/3 mg, for sale in the U.S. market. The product was launched immediately after approval, with sales and commercialization activities halted as a result of a court-imposed temporary restraining order (TRO) and preliminary injunction against Dr. Reddy’s. The TRO and preliminary injunction did not prohibit commercial manufacturing of the product. ]]> <![CDATA[SCHOTT KAISHA’s first-of-its kind roadshow to bring multiple customers, partners and prospects together]]> https://biospectrumindia.com/news/95/12882/schott-kaishas-first-of-its-kind-roadshow-to-bring-multiple-customers-partners-and-prospects-together.html https://biospectrumindia.com/news/95/12882/schott-kaishas-first-of-its-kind-roadshow-to-bring-multiple-customers-partners-and-prospects-together.html Wed, 20 Feb 2019 14:40:00 +0530 Starting next week, leading pharmaceutical packaging company, SCHOTT KAISHA will host a roadshow in five Indian cities: Chandigarh, Ahmedabad, Mumbai, Bangalore and Hyderabad to ensure that its customers are up to date with industry trends and best practices. The Indo-German joint venture aims to promote optimal process-driven technologies and their impact on Type 1 primary packaging glass containers for life saving drugs. To be held over 2 weeks starting February 25th, the roadshow will provide customers and potential partners key insights into the manufacturing process of primary pharma packaging, the advanced technology SCHOTT KAISHA uses and the impact that this technology has on the container during the conversion process. This will give participants a clear understanding on the importance of conversion process in tubular glass manufacturing. In addition, the event shall also showcase SCHOTT KAISHA’s upcoming product portfolio, tailor-made design and development capabilities. Rishad Dadachanji, Director, SCHOTT KAISHA shares, “We have always believed in not finding customers for our products, but in finding products for customers. That is why we have always worked with our partners to ensure product compatibility between their solutions and ours. The roadshow is thus, not only a platform to bring us closer, but also an opportunity for our partners to showcase unique solutions available with them.” It is for the first time that a pharma packaging company is taking such a grand initiative to bring together a wide array of customers from all functions (including FR&D, Packaging Development, Production, Quality and Procurement) under one roof in multiple cities over a short period of time. Moreover, SCHOTT KAISHA will be hosting industry partners such as ACE Technologies, Aptar Pharma, Datwyler, Kaisha Lifesciences, Nemera, Packwell Industries, Shakai Packaging Pvt. Ltd., Smart Skin Technologies, Snowbell Machines Pvt. Ltd., Sovereign Pharma Pvt. Ltd. and Vanrx Pharmasystems Inc. Information regarding roadshow: Date City February 25 Chandigarh February 27 Ahmedabad March 1 Mumbai March 11 Bangalore March 15 Hyderabad   ]]> <![CDATA[Glenmark to present new analysis on Ryaltris at the AAAAI 2019 ]]> https://biospectrumindia.com/news/95/12881/glenmark-to-present-new-analysis-on-ryaltris-at-the-aaaai-2019-.html https://biospectrumindia.com/news/95/12881/glenmark-to-present-new-analysis-on-ryaltris-at-the-aaaai-2019-.html Wed, 20 Feb 2019 12:55:00 +0530 Glenmark Pharmaceuticals has announced upcoming presentations of pooled data from clinical studies of Ryaltris™ (olopatadine hydrochloride [665 mcg] and mometasone furoate [25 mcg]), formerly GSP 301 Nasal Spray, an investigational fixed-dose combination nasal spray for the treatment of seasonal allergic rhinitis (SAR) in patients 12 years of age and older, at the 2019 Annual Meeting of the American Academy of Allergy, Asthma and Immunology (AAAAI 2019) in San Francisco, California. “Ryaltris” has been conditionally accepted by the FDA as the brand name. Mahboob Rahman, Chief Medical Officer at Glenmark Pharmaceuticals said, “We continue to evaluate the clinical profile of Ryaltris based on findings from our completed efficacy and safety studies. These new, pooled analyses on key outcomes from thousands of patients provide additional insights into the potential effectiveness of Ryaltris. With the target action date for completion of FDA review of Ryaltris less than two months away, we are pleased for the opportunity to present these data at AAAAI 2019.” Glenmark Pharmaceuticals has studied Ryaltris in seven clinical trials involving more than 4,000 patients. Results from clinical trials of Ryaltris have been previously presented at key medical meetings. If approved by the FDA, Ryaltris will be commercialized by Glenmark Therapeutics Inc., USA, a wholly-owned subsidiary of Glenmark Holding, SA, that is dedicated to launching and commercializing a portfolio of branded products in the therapeutic areas of respiratory and dermatology in the United States.   ]]> <![CDATA[Thermo Fisher to expand with $35M supply chain facility]]> https://biospectrumindia.com/news/95/12877/thermo-fisher-to-expand-with-35m-supply-chain-facility.html https://biospectrumindia.com/news/95/12877/thermo-fisher-to-expand-with-35m-supply-chain-facility.html Wed, 20 Feb 2019 11:15:00 +0530 Thermo Fisher Scientific announces to start construction of a new $35 million state-of-the-art pharma services supply chain facility in Rheinfelden (Baden) Germany.  The facility expands Thermo Fisher’s footprint in the European Union. The new facility will feature the latest technology and modern infrastructure to significantly increase European capacity for cold and ambient clinical trial materials in support of complex clinical research and so meet the growing needs of customers. The facility will be scalable for mixed-use space and provide a strategic logistical location for shipping either by road or air.  Construction of the 8,000 square meter facility is expected to take 12 to 18 months. Once complete, this new facility will provide up to 200 new jobs locally. The investment includes the option for additional expansion with the potential for doubling the footprint.  The company’s decision to expand is in response to a growing demand for global clinical supply services, worldwide. The new facility will also serve to address GDP guidelines, Clinical Trial Regulations Annex 6 and the new Falsified Medicines Directive 2019. This GMP/GDP facility builds on the company’s existing footprint of 20 purpose-built cGMP facilities globally. ]]> <![CDATA[Essilor India unveils Crizal Sapphire 360° UV lenses for Millennial]]> https://biospectrumindia.com/news/95/12868/essilor-india-unveils-crizal-sapphire-360-uv-lenses-for-millennial.html https://biospectrumindia.com/news/95/12868/essilor-india-unveils-crizal-sapphire-360-uv-lenses-for-millennial.html Tue, 19 Feb 2019 15:05:00 +0530 Essilor, who was ranked for the 7th consecutive year by Forbes among the 100 most innovative companies of the world, launched a new lens of Crizal named Crizal Sapphire 360° UV with the thought of, ‘Making the invisible, a new visible’, targeted towards the millennial. The millennial are not an easy demography to crack, but marketers are tapping their love for technology, innovation, minimalistic lifestyle to grab their attention, and this time Crizal in an effort to market the millennial and their individualism, launched Crizal Sapphire 360° UV, a nearly invisible anti - reflective lenses with the notion of making the invisible a new visible. Crizal Sapphire 360°UV coating is the latest innovation in the 25 years history of one of the Group’s flagship brands – Crizal, first launched in 1992 to improve visual comfort by reducing glare and enhancing the transparency and durability of lenses. The world is changing and so is Essilor. Maarten Geraets, CEO, Greater India said,“Our business serves an essential purpose of improving lives by improving sight and at Essilor we constantly strive to be relevant with changing times. Keeping in mind the minimalistic design preference of the millennials, the nearly invisible Crizal Sapphire 360° UV helps them enjoy uninterrupted and more vivid vision.”He continues, “Through an in-depth study of the changes in our daily light environment as well as consumer expectations, Essilor R&D teams set out to improve visual comfort through better anti-reflective performance and lens transparency with another level of innovation. Crizal Sapphire 360o UV is a revolutionary vision solution targeted towards the millennial, who are the game changers in today’s dynamic market.” Ramachandran P, COO, Essilor India said, “When it comes to innovation, Essilor is the leader in the ophthalmic lens category andwith the launch of Crizal Sapphire 360o UV we are taking another step forward. Through a new consumer-focused approach, we are offering nearly invisible anti-reflective lenses with the best in class transparency.” Essilor India is a 100% subsidiary of Essilor International marks its 20th year since its advent in India this year. The Company through its excellent services, quality products and a wide network of distributors and franchise labs has been able to revolutionize the Indian ophthalmic lens market and cause a shift from the predominant glass lenses to the safer and more superior plastic lenses. Essilor offers a wide range of the world’s best lenses- “Varilux” range of Progressive Lenses, “Crizal” Hard Multicoated Lenses , “Optifog” anti-fog technology, ”Airwear” polycarbonate lenses to suit all lifestyles and “Titus” Hard Coated Lenses which have set benchmarks for quality and performance. Besides these products, Essilor has an impressive array of photo chromic, tinted and high index lenses as well as lenses for special applications. Essilor also has brought international best practices into India in the areas of training and promotional activities. The company, which distributes products in more than 100 countries, has 28 production plants, more than 450 prescription laboratories and cutting and mounting centres as well as several research and development centers worldwide.   ]]> <![CDATA[India Ratings and Research maintains a stable outlook on the Indian pharmaceutical sector ]]> https://biospectrumindia.com/reports-white-papers/95/12865/india-ratings-and-research-maintains-a-stable-outlook-on-the-indian-pharmaceutical-sector-.html https://biospectrumindia.com/reports-white-papers/95/12865/india-ratings-and-research-maintains-a-stable-outlook-on-the-indian-pharmaceutical-sector-.html Tue, 19 Feb 2019 14:50:00 +0530 India Ratings and Research (Ind-Ra) has maintained a stable outlook on the Indian pharmaceutical sector due to the expected recovery in margins, improved cash generation on the back of emerging pricing stability in the US generic drug market, and robust growth in the domestic pharmaceutical market. While investment requirements are likely to increase substantially, strong balance sheets and adequate liquidity lend additional support to the outlook. With the exit of major global companies from select product segments in the US generic drug market and the slim likelihood of buyer consolidation intensifying further, the improvements in the pricing environment might sustain well into FY20. Most large Indian pharmaceutical companies have robust product pipelines, which could support margin recovery. The domestic pharmaceutical sector is likely to maintain its current growth momentum in FY20, with chronic therapies emerging as strong drivers of growth. Considering the government’s increasing focus on providing greater access to quality healthcare in the country, this segment would continue to see regulatory interventions, especially in terms of price controls. Ind-Ra believes the US generic drug market is undergoing a rapid transformation, and over the next decade, Indian pharmaceutical companies would need to possess different product capabilities to remain profitable. Complex generics, such as injectables, long-acting drugs and other alternate dosage forms, will have relatively better margin profiles compared to traditional oral solids, which remains a mainstay for most Indian companies. Biosimilars, as a product category, have gained approval momentum in 2018 and are likely to grow multifold in the medium term. Most large Indian pharmaceutical companies have sizeable pipelines of complex generics and are gradually shifting focus towards specialty drugs. However, the absence in the biosimilar space will remain a glaring gap in the product strategies of most Indian companies. Ind-Ra expects most large issuers to aggressively deploy capital in FY20 towards necessary investments in new product platforms to strengthen their market-readiness for the medium term. Prices of active pharmaceutical ingredients produced by China have started to soften. However, Ind-Ra believes the prices are likely to settle at higher-than-the-previous-average levels. To implement strict environmental regulations, most Chinese producers had to upgrade facilities, and in some cases, tweak production processes. This has permanently increased the production cost and cycle times, which will act as a floor for price correction. However, most large Indian pharmaceutical companies are pursuing meaningful cost-saving initiatives, including portfolio optimisation, divesting non-core manufacturing facilities and optimising research and development expenditure. This along with currency depreciation could largely offset the increase in input costs. While the sector is accustomed to acquisition-driven growth, most of the current investments are medium-term plays, wherein the deriving of synergy benefits could take three to five years from the deployment of capital. This could result in a more gradual deleveraging. ]]> <![CDATA[Cipla, Wellthy to offer digital therapeutics for Diabetes, CVDs]]> https://biospectrumindia.com/news/95/12858/cipla-wellthy-to-offer-digital-therapeutics-for-diabetes-cvds.html https://biospectrumindia.com/news/95/12858/cipla-wellthy-to-offer-digital-therapeutics-for-diabetes-cvds.html Tue, 19 Feb 2019 09:00:00 +0530 Cipla Limited and Wellthy Therapeutics have announced that they have entered into a partnership to offer a combination of pharmacotherapy and digital therapeutics for improved patient outcomes in the chronic therapies of diabetology and cardiology. Under the agreement, a multi-lingual clinically-validated digital disease management platform will be made available to patients living with diabetes or cardiovascular diseases via doctors’ clinics or co-packaging on select Cipla brands. The platform brings together behavioural science, real world clinical evidence and artificial intelligence to provide real time monitoring, coaching and advice to patients, and virtual clinical assistance to doctors. This partnership is a result of Cipla’s campaign, Innoventia, which was envisioned as a first-of-its-kind challenge by an Indian pharmaceutical company to encourage innovation-led entrepreneurship and to harness disruptive ideas in healthcare to fulfil unmet patient needs. Umang Vohra, MD & Global CEO of Cipla, said, “The future of healthcare will be driven by increased use of technology, and this partnership gives Cipla the ability to offer this combination of prescription drugs and artificial intelligence-powered digital therapeutics to patients in cardio-metabolic health. It will allow patients to make informed decisions and take charge of their own health. By pairing our pharmacotherapy strengths with the digital approach to healthcare taken by Wellthy Therapeutics, Cipla will add to its diversified portfolio in the cardio-metabolic area to provide holistic care to patients from awareness, diagnosis and compliance to well-being.” Abhishek Shah, Co-founder & CEO of Wellthy Therapeutics, said, “We are excited to work with Cipla to bring digital therapeutics to patients in India. Companion digital therapeutics are redefining the treatment of chronic conditions, by helping personalise and simplify disease management for patients, and driving precision clinical insights to clinicians. With the combination of Cipla’s world class formulations and clinically validated digital therapeutics of Wellthy Therapeutics, we look forward to helping empower and inspire millions of patients to achieve better, sustainable health outcomes.”   ]]> <![CDATA[Orit Lab gets USFDA nod for Fenofibrate Tablets]]> https://biospectrumindia.com/news/95/12846/orit-lab-gets-usfda-nod-for-fenofibrate-tablets.html https://biospectrumindia.com/news/95/12846/orit-lab-gets-usfda-nod-for-fenofibrate-tablets.html Mon, 18 Feb 2019 12:30:00 +0530 Alembic Pharmaceuticals Limited (Alembic) has announced that its wholly owned step down subsidiary Orit Laboratories LLC has received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Fenofibrate Tablets USP, 54 mg and 160 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Tricor Tablets, 54 mg and 160 mg, of AbbVie Inc. (AbbVie). Fenofibrate Tablets USP, 54 mg and 160 mg are indicated as an adjunct to diet to reduce elevated LDL-C, Total-C, TG and Apo B, and to increase HDL-C in adult patients with primary hypercholesterolemia or mixed dyslipidaemia and for treatment of adult patients with severe hypertriglyceridemia. Fenofibrate Tablets USP, 54 mg and 160 mg have an estimated market size of US$ 92 million for twelve months ending December 2018 according to IQVIA. Alembic has a cumulative total of 85 ANDA approvals (72 final approvals and 13 tentative approvals) from USFDA. ]]> <![CDATA[Glenmark receives ANDA approval for Clobetasol Propionate Foam]]> https://biospectrumindia.com/news/95/12845/glenmark-receives-anda-approval-for-clobetasol-propionate-foam.html https://biospectrumindia.com/news/95/12845/glenmark-receives-anda-approval-for-clobetasol-propionate-foam.html Mon, 18 Feb 2019 12:10:00 +0530 Glenmark Pharmaceuticals has been granted final approval by the United States Food & Drug Administration (U.S. FDA) for Clobetasol Propionate Foam, 0.05%, a generic version of Olux®1 Foam, 0.05%, of Mylan Pharmaceuticals, Inc. According to IQVIATM sales data for the 12 month period ending December 2018, the Olux® Foam, 0.05% market2 achieved annual sales of approximately $50.9 million. Glenmark’s current portfolio consists of 150 products authorized for distribution in the U.S. marketplace and 52 ANDA’s pending approval with the U.S. FDA. ]]> <![CDATA[Alembic Pharma gets USFDA nod for Moxifloxacin Ophthalmic Solution ]]> https://biospectrumindia.com/news/95/12844/alembic-pharma-gets-usfda-nod-for-moxifloxacin-ophthalmic-solution-.html https://biospectrumindia.com/news/95/12844/alembic-pharma-gets-usfda-nod-for-moxifloxacin-ophthalmic-solution-.html Mon, 18 Feb 2019 10:05:00 +0530 Alembic Pharmaceuticals Limited (Alembic) announced that it has received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Moxifloxacin Ophthalmic Solution USP, 0.5%. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD) Vigamox Ophthalmic Solution USP, 0.5%, of Novartis Pharmaceuticals Corporation. Moxifloxacin Ophthalmic Solution USP, 0.5% is indicated for the treatment of bacterial conjunctivitis caused by susceptible strains of certain organisms. Moxifloxacin Ophthalmic Solution USP, 0.5% has an estimated market size of US$ 68 million for twelve months ending December 2018 according to IQVIA. Alembic has a cumulative total of 86 ANDA approvals (73 final approvals and 13 tentative approvals) from USFDA. ]]> <![CDATA[Bharat Biotech acquires Chiron Behring Vaccines]]> https://biospectrumindia.com/news/95/12839/bharat-biotech-acquires-chiron-behring-vaccines.html https://biospectrumindia.com/news/95/12839/bharat-biotech-acquires-chiron-behring-vaccines.html Mon, 18 Feb 2019 09:00:00 +0530 Bharat Biotech has announced the forthcoming acquisition of Chiron Behring Vaccines Pvt Ltd, located in Ankleshwar, Gujarat from GlaxoSmithKline Asia. Bharat Biotech will acquire 100% equity stake in Chiron Behring Vaccines in an all cash transaction, subject to a number of closing conditions which Bharat Biotech and GSK intend to complete in the coming weeks. Chiron Behring Vaccines was formed as a result of the purchase of the vaccines business of Hoechst AG by Chiron Corporation USA. It is one of the largest manufacturers of high quality rabies vaccines in the world. Chiron Behring Vaccines is a WHO Pre-qualified manufacturer of rabies vaccines, eligible for supplies to UN agencies and has product registrations in more than 20 countries. The rabies vaccinemanufactured at Ankleshwar is a result of decades of research & product development. Bharat Biotech has a wide portfolio of vaccines, with market access to more than 70 countries. The addition of this rabies vaccine will establish Bharat Biotech as a global leader in rabies vaccines manufacturing. Bharat Biotech plans to enhance upon the manufacturing capabilities at Chiron Behring Vaccines and expand market access through product registrations in additional high demand countries. Announcing the deal, Dr. Krishna Ella, Chairman and Managing Director of Bharat Biotech, said: “This acquisition is strategic in helping us enhance our opportunities to achieve greater scale in tackling public health problems. Bharat Biotech will strengthen its product portfolio and substantially increase product availability in response to the growing demand for this vaccine.  With the significant disease burden of rabies in India and other countries, I appreciate GSK’s vision in this transition to Bharat Biotech, to continue to meet the needs of the patients.” ]]> <![CDATA[Lupin launches Clobazam Oral Suspension to treat seizures]]> https://biospectrumindia.com/news/95/12843/lupin-launches-clobazam-oral-suspension-to-treat-seizures.html https://biospectrumindia.com/news/95/12843/lupin-launches-clobazam-oral-suspension-to-treat-seizures.html Mon, 18 Feb 2019 09:00:00 +0530 Pharma major Lupin has announced the launch of Clobazam Oral Suspension, 2.5mg/mL, having received an approval from the United States Food and Drug Administration (FDA) earlier. Lupin’s Clobazam Oral Suspension, 2.5mg/mL is the generic version of Lundbeck Pharmaceuticals LLC’s Onfi Oral Suspension, 2.5mg/mL. It is indicated for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 2 years of age or older. Clobazam Oral Suspension, 2.5mg/mL had annual sales of $253 million in the US (IQVIA MAT December 2018). ]]> <![CDATA[Glenmark to spin off its innovation business in US]]> https://biospectrumindia.com/news/95/12833/glenmark-to-spin-off-its-innovation-business-in-us.html https://biospectrumindia.com/news/95/12833/glenmark-to-spin-off-its-innovation-business-in-us.html Fri, 15 Feb 2019 09:30:00 +0530 Glenmark Pharmaceuticals has announced that its Board of Directors has given an in-principle approval to spin off the innovation business into a new company in the US. Setting up of the new company will provide an enhanced focus to the innovation business and help accelerate the pipeline towards commercialization. The new innovation company will be a wholly-owned subsidiary of Glenmark and will be based in the US. It will have an independent board and a new Chief Executive Officer. The other members of the management and the team remain unchanged. According to the plan, all innovative molecules in the pipeline, including preclinical assets and technology; the R&D centres in Switzerland, R&D centre at Paramus in the US and R&D centre at Navi Mumbai, India related to the innovation business, and the biologics manufacturing facility in Switzerland along with all employees associated with innovative R&D will be part of the new company. The new company will have over 400 employees as part of this business. The specialty and generics business will continue to be housed in the parent company and will not be part of this new company. The transfer of the assets and employees to the new innovation company is expected to be completed in the next 6 to 9 months. Glenn Saldanha, chairman and managing director of Glenmark Pharmaceuticals said, “Glenmark has built strong capabilities in the area of innovation in terms of world class infrastructure, talent pool, and technology. We currently have a pipeline of 8 NMEs most of which are first-in-class globally. The cutting edge work that the innovation team has delivered over the years has resulted in numerous achievements most notably among them being the fact that we have out-licensed our novel molecules to big pharmaceutical organizations consistently. With the pipeline at an advanced stage, we believe it’s the right time for the innovation business to be an independent entity and charter its own journey towards becoming a leading biotech organization globally. This change will provide enhanced focus to the business, a better operating ecosystem and additional opportunities to unlock value for the parent company in future.” Glenmark’s current innovation pipeline consists of 8 assets, including new chemical entities (NCEs) and new biological entities (NBEs), in various stages of development in the areas of immunology, oncology and pain management. The pipeline includes 3 immuno-oncology bispecific antibodies developed through Glenmark’s proprietary BEAT® platform. The new company will further leverage the BEAT platform to enhance the pipeline. Of the 5 clinical and 3 pre-clinical assets in development, 2 clinical assets are currently in Phase 2b, and 1 asset is likely to enter Phase 2b in FY20. ]]> <![CDATA[Jubilant Biosys collaborates with Sanofi in CNS therapeutic area]]> https://biospectrumindia.com/news/95/12819/jubilant-biosys-collaborates-with-sanofi-in-cns-therapeutic-area.html https://biospectrumindia.com/news/95/12819/jubilant-biosys-collaborates-with-sanofi-in-cns-therapeutic-area.html Thu, 14 Feb 2019 10:00:00 +0530 Jubilant Biosys, a Bengaluru-based subsidiary of Jubilant Life Sciences has announced a new integrated drug discovery collaboration with Sanofi in the CNS therapeutic area. The first collaboration with Sanofi started in 2016, to discover and develop small molecule inhibitors for multiple targets in the metabolic disorders therapeutic area. Marcel Velterop, President – Jubilant Drug Discovery Services and CDMO, said: “We are delighted and privileged to have been selected again by a major pharmaceutical company such as Sanofi to help bring new innovation to the clinic. This achievement is a testimony to the high quality science and capability which Jubilant has built over the past decade. It fits well with our growth strategy and we are committed to expand our world class integrated drug discovery capabilities.” Rita Balice-Gordon, Global Head of Rare and Neurologic Diseases Therapeutic Area, said: “We are looking forward to collaborating further with Jubilant. This new collaboration demonstrates Sanofi’s commitment to working to discover new medicines that target neurological diseases with high unmet need around the globe.” The new research collaboration is aimed at discovering therapeutic small molecules that will address unmet needs in neurological diseases. Jubilant Biosys shall provide Sanofi drug discovery services utilizing its integrated drug discovery platform to identify lead candidates. ]]> <![CDATA[Lupin launches Tadalafil Tablets]]> https://biospectrumindia.com/news/95/12813/lupin-launches-tadalafil-tablets.html https://biospectrumindia.com/news/95/12813/lupin-launches-tadalafil-tablets.html Wed, 13 Feb 2019 10:30:00 +0530 Pharma major Lupin announced the launch of Tadalafil Tablets USP 20mg, having received an approval from the United States Food and Drug Administration (FDA) earlier. Lupin’s Tadalafil Tablets USP 20mg is the generic equivalent of Eli Lilly’s Adcirca Tablets 20mg. It is indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise ability. Tadalafil Tablets, 20mg had annual sales of approximately US$474.3 million in the US (IQVIA MAT December 2018). ]]> <![CDATA[Lupin receives FDA approval for Fluoxetine Tablets ]]> https://biospectrumindia.com/news/95/12812/lupin-receives-fda-approval-for-fluoxetine-tablets-.html https://biospectrumindia.com/news/95/12812/lupin-receives-fda-approval-for-fluoxetine-tablets-.html Wed, 13 Feb 2019 10:25:00 +0530 Pharma major Lupin announced that it has received approval for its Fluoxetine Tablets USP, 60mg, from the United States Food and Drug Administration (FDA) to market a generic version of Alvogen’s Fluoxetine Tablets, 60mg. Lupin’s Fluoxetine Tablets USP, 60mg, is the generic version of Alvogen’s Fluoxetine Tablets, 60mg. It is indicated in the treatment of: Major Depressive Disorder (MDD) Adults: Efficacy was established in one 5-week trial, three 6-week trials, and one maintenance study. Pediatrics: Efficacy was established in two 8- to 9-week trials of patients 8 to 18 years of age. Obsessive Compulsive Disorder (OCD) Adults: Efficacy was established in two 13-week trials. Pediatrics: Efficacy was established in one 13-week trial in pediatric patients 7 to 17 years of age. Bulimia Nervosa Adults: Efficacy was established in two 8-week trials and one 16-week trial. Panic disorder, with or without agoraphobia Adults: Efficacy was established in two 12-week trials. Fluoxetine Tablets, 60mg, had annual sales of approximately USD 42.5 million in the US (IQVIA MAT December 2018).   ]]> <![CDATA[Aurobindo completes acquisition of Apotex’s five European Biz]]> https://biospectrumindia.com/news/95/12807/aurobindo-completes-acquisition-of-apotexs-five-european-biz.html https://biospectrumindia.com/news/95/12807/aurobindo-completes-acquisition-of-apotexs-five-european-biz.html Wed, 13 Feb 2019 09:00:00 +0530 Aurobindo Pharma Limited, a world-leading marketer and manufacturer of generic pharmaceuticals and active pharmaceutical ingredients, has announced that it has closed the acquisition of Apotex’s commercial operations and certain supporting infrastructure in five European countries. The binding agreement to acquire five of Apotex' European businesses, including infrastructure, personnel, products, certain established trademarks, marketing authorizations and dossier license rights in Poland, the Czech Republic, the Netherlands (including the manufacturing facility in Leiden), Spain and Belgium was announced on 14 July 2018. This announcement does not constitute a recommendation to shareholders or potential investors. Jefferies International Limited acted as sole financial advisor and Herbert Smith Freehills LLP acted as legal counsel to Aurobindo. Ernst & Young, India provided financial due diligence services. ]]> <![CDATA[Dr. Reddy's Laboratories launches Tadalafil Tablets USP in the U.S. Market]]> https://biospectrumindia.com/news/95/12811/dr-reddys-laboratories-launches-tadalafil-tablets-usp-in-the-u-s-market.html https://biospectrumindia.com/news/95/12811/dr-reddys-laboratories-launches-tadalafil-tablets-usp-in-the-u-s-market.html Tue, 12 Feb 2019 18:25:00 +0530 Dr. Reddy’s Laboratories Ltd. ((BSE: 500124, NSE: DRREDDY, NYSE: RDY), along with its subsidiaries together referred to as “Dr. Reddy’s”) has announced the launch of Tadalafil Tablets USP, a therapeutic equivalent generic version of Adcirca (tadalafil) Tablets in the United States market, approved by the U.S. Food and Drug Administration (USFDA). The Adcirca brand and generic had U.S. sales of approximately $490 million MAT for the most recent twelve months ending in November 2018 according to IMS Health*. Dr. Reddy’s Tadalafil Tablets are available in 20 mg with 60 count bottle size. Adcirca is a trademark of Eli Lilly and Company and is indicated in adults for the treatment of pulmonary arterial hypertension (PAH) classified as WHO functional class II and III, to improve exercise capacity. Dr. Reddy’s Laboratories Ltd. is an integrated pharmaceutical company, committed to providing affordable and innovative medicines for healthier lives. Through its three businesses - Pharmaceutical Services & Active Ingredients, Global Generics and Proprietary Products – Dr. Reddy’s offers a portfolio of products and services including APIs, custom pharmaceutical services, generics, biosimilars and differentiated formulations. Our major therapeutic areas of focus are gastrointestinal, cardiovascular, diabetology, oncology, pain management and dermatology. Dr. Reddy’s operates in markets across the globe. Our major markets include – USA, India, Russia & CIS countries, and Europe. *IMS National Sales Perspective: Retail and Non-Retail MAT November 2018 RDY-0219-234 ]]> <![CDATA[Dr. Reddy's launches Tadalafil Tablets ]]> https://biospectrumindia.com/news/95/12805/dr-reddys-launches-tadalafil-tablets-.html https://biospectrumindia.com/news/95/12805/dr-reddys-launches-tadalafil-tablets-.html Tue, 12 Feb 2019 15:35:00 +0530 Dr. Reddy’s Laboratories has announced the launch of Tadalafil Tablets USP, a therapeutic equivalent generic version of Adcirca (tadalafil) Tablets in the United States market, approved by the U.S. Food and Drug Administration (USFDA). The Adcirca brand and generic had U.S. sales of approximately $490 million MAT for the most recent twelve months ending in November 2018 according to IMS Health. Dr. Reddy’s Tadalafil Tablets are available in 20 mg with 60 count bottle size. Adcirca is a trademark of Eli Lilly and Company. ]]> <![CDATA[USFDA completes inspection of Lupin’s Goa facility]]> https://biospectrumindia.com/news/95/12797/usfda-completes-inspection-of-lupins-goa-facility.html https://biospectrumindia.com/news/95/12797/usfda-completes-inspection-of-lupins-goa-facility.html Tue, 12 Feb 2019 09:40:00 +0530 Pharma major Lupin announced the completion of the United States Food and Drug Administration (U.S. FDA) inspection at its Goa manufacturing facility. The inspection was carried out between January 28 to February 8, 2019. As per the company statement, ”The inspection at the Goa facility closed with 2 observations. The observations are procedural in nature and the Company is confident of addressing them satisfactorily.” For the financial year ended 31st March, 2018, Lupin’s Consolidated sales and Net profits before exceptional items were at Rs. 155,598 million (USD 2.41 billion) and Rs. 13,934 million (USD 216 million) respectively ]]> <![CDATA[Zydus receives USFDA approval for anticonvulsant drug]]> https://biospectrumindia.com/news/95/12796/zydus-receives-usfda-approval-for-anticonvulsant-drug.html https://biospectrumindia.com/news/95/12796/zydus-receives-usfda-approval-for-anticonvulsant-drug.html Tue, 12 Feb 2019 09:00:00 +0530 Zydus Cadila has received the final approval from the USFDA to market Carbamazepine Extended-Release Tablets USP (US RLD – Tegretol XR), 100 mg, 200 mg, and 400 mg. It will be manufactured at the group’s formulations manufacturing facility at Moraiya, Ahmedabad. Carbamazepine is an anticonvulsant agent. It works by reducing excessive nerve signals in the brain and restoring the normal balance of nerve activity. This medication is used to treat certain types of seizures (partial, generalized tonic-clonic, mixed) and certain types of nerve pain (trigeminal and glossopharyngeal neuralgia). The group now has 248 approvals and has so far filed over 350 ANDAs since the commencement of the filing process in FY 2003-04 ]]> <![CDATA[IPA urges USTR for removal of India from Priority Watch List]]> https://biospectrumindia.com/news/95/12786/ipa-urges-ustr-for-removal-of-india-from-priority-watch-list.html https://biospectrumindia.com/news/95/12786/ipa-urges-ustr-for-removal-of-india-from-priority-watch-list.html Mon, 11 Feb 2019 10:40:00 +0530 IPA has drawn the attention of the USTR to the rapid progress made by India on a number of fronts which were cited by the USTR while placing India on the Priority Watch List in 2018. The 2018 Report had asserted that ‘India has yet to take steps to address longstanding patent issues’, among which were the ‘long timelines for receiving patents’. IPA has pointed out that a number of steps have been taken by the Patent Office to augment manpower and streamline procedures which have resulted in the transformation of the Patent Office. As a result, patent examination time has been brought down drastically. Patents pending examination have come down from 204,177 as on 31 March 2017 to 127, 881 as on 31 December 2018. India now examines trademark applications in about one month and registrations are completed in a year or less. Commenting on this development, D G Shah, the Secretary General of the IPA said, ‘India now has one of the lowest examination times for trademark registration in the world and the indications are that patent examination backlog will be eliminated in about two years. Processing delays are no longer a concern and we hope that the USTR will take note of this.’ The more substantive concerns of the U.S. pharmaceutical industry stemming from some provisions in India’s IP Laws are: One that is particularly troublesome to innovator companies is Section 3(d) which prohibits the grant of ‘evergreening’ patents. These are additional patents for a drug with no therapeutic benefit and serve only to increase the term of patent monopoly. Consequently, the availability of affordable generics is delayed and assures innovators of an extended period of monopoly pricing. India also does not provide a term of data (market) exclusivity for a new drug, quite apart from the monopoly conferred by a patent for it. Compulsory licensing of patent permitting generic manufacturers to develop and market an affordable generic version when the price of the innovator drug is very high is another major irritant to innovator companies. The extraordinarily high prices of new drugs is a cause of considerable concern globally’, says D G Shah. ‘Even developed countries in Europe such as Netherlands and Switzerland are exploring the possibility of compulsory licensing as a means to control prices of new drugs’. IPA has strongly defended India’s patent law which is TRIPS-compliant and strikes a balance between the need to assure innovators of profits for their useful inventions and safeguarding public health. Each year, the Office of the United States Trade Representative (USTR) conducts a Special 301 review to identify countries that deny adequate and effective protection of intellectual property rights (IPR) or deny fair and equitable market access to U.S. persons who rely on intellectual property protection. Based on this review, the United States Trade Representative determines which of these countries are identified as Priority Foreign Countries. Once a country is identified as a Priority Foreign Country, the USTR must open a Section 301 investigation, which may lead to trade sanctions. In addition, USTR has created a “Priority Watch List” and “Watch List” to assist the U.S. Administration in pursuing the goals of the Special 301 provisions. Placement of a trading partner on the Priority Watch List or Watch List indicates that particular problems exist in that country with respect to IPR protection, enforcement, or market access for persons that rely on intellectual property protection. Trading partners placed on the Priority Watch List are the focus of increased bilateral attention concerning the problem areas. To facilitate the Special 301 Review, USTR invites written submissions. The period for submissions closed on 7 February 2019. The USTR will hold a public hearing for those who wish to appear before it as a witness and make oral submissions on 27 February 2019. The Special 301 Report will be released on or about 26 April 2019. India is one of the twelve countries placed in the Priority Watch List consequent to the 2018 Special Review. The other countries are Algeria, Argentina, Canada, Chile, China, Colombia, Indonesia, Kuwait, Russia, Ukraine and Venezuela. The Indian Pharmaceutical Alliance (IPA) is an association of twenty-two pharmaceutical companies which collectively account for over 85 per cent of the private sector investment in pharmaceutical research and development, more than 80 per cent of India’s pharmaceutical exports and over 50 per cent of the domestic pharmaceutical market. ]]> <![CDATA[Glenmark receives ANDA approval for Sevelamer Hydrochloride Tablets]]> https://biospectrumindia.com/news/95/12784/glenmark-receives-anda-approval-for-sevelamer-hydrochloride-tablets.html https://biospectrumindia.com/news/95/12784/glenmark-receives-anda-approval-for-sevelamer-hydrochloride-tablets.html Mon, 11 Feb 2019 09:40:00 +0530 Glenmark Pharmaceuticals has been granted final approval by the United States Food & Drug Administration for Sevelamer Hydrochloride Tablets, 400 mg and 800 mg, a generic version of Renagel Tablets, 400 mg and 800 mg, of Genzyme Corporation. According to IQVIATM sales data for the 12 month period ending December 2018, the Renagel Tablets, 400 mg and 800 mg market2 achieved annual sales of approximately $102.1 million. Glenmark’s current portfolio consists of 149 products authorized for distribution in the U.S. marketplace and 53 ANDA’s pending approval with the U.S. FDA.   ]]> <![CDATA[Lupin receives FDA approval for Tadalafil ]]> https://biospectrumindia.com/news/95/12760/lupin-receives-fda-approval-for-tadalafil-.html https://biospectrumindia.com/news/95/12760/lupin-receives-fda-approval-for-tadalafil-.html Thu, 07 Feb 2019 14:35:00 +0530 Pharma major Lupin announced that it has received approval for its Tadalafil Tablets USP, 20 mg from the United States Food and Drug Administration (FDA) to market a generic version of Eli Lilly and Company’s Adcirca Tablets, 20 mg. Lupin’s Tadalafil Tablets USP, 20 mg is the generic version of Eli Lilly and Company’s Adcirca Tablets, 20 mg. It is indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise ability. Tadalafil Tablets, 20 mg had annual sales of approximately USD 474.3 million in the US (IQVIA MAT December 2018).   ]]> <![CDATA[Cipla receives final approval for generic version of Adcirca]]> https://biospectrumindia.com/news/95/12756/cipla-receives-final-approval-for-generic-version-of-adcirca.html https://biospectrumindia.com/news/95/12756/cipla-receives-final-approval-for-generic-version-of-adcirca.html Thu, 07 Feb 2019 10:20:00 +0530 Cipla has announced that it has received final approval for its Abbreviated New Drug Application (ANDA) for Tadalafil Tablets 20mg from the United States Food and Drug Administration (US FDA). Cipla’s Tadalafil Tablets 20mg is AB-rated generic therapeutic equivalent version of Eli Lilly & Co.’s Adcirca. It is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise ability. According to IQVIA (IMS Health), Adcirca and its generic equivalents had US sales of approximately $490M for the 12-month period ending November 2018. The product is available for shipping immediately. ]]> <![CDATA[Glenmark receives tentative ANDA approval for Fulvestrant]]> https://biospectrumindia.com/news/95/12755/glenmark-receives-tentative-anda-approval-for-fulvestrant.html https://biospectrumindia.com/news/95/12755/glenmark-receives-tentative-anda-approval-for-fulvestrant.html Thu, 07 Feb 2019 10:15:00 +0530 Glenmark Pharmaceuticals has been granted tentative approval by the United States Food & Drug Administration (U.S. FDA) for Fulvestrant Injection, 250 mg/5 mL (50 mg/mL), a generic version of FASLODEX Injection, 250 mg/5 mL (50mg/mL), of AstraZeneca Pharmaceuticals LP. According to IQVIATM sales data for the 12 month period ending December 2018, the FASLODEX® Injection, 250 mg/5 mL (50 mg/mL) market2 achieved annual sales of approximately $533.3 million. Glenmark’s current portfolio consists of 148 products authorized for distribution in the U.S. marketplace and 54 ANDA’s pending approval with the U.S. FDA. ]]> <![CDATA[Cipla receives final approval for generic version of Adcirca]]> https://biospectrumindia.com/news/95/12751/cipla-receives-final-approval-for-generic-version-of-adcirca.html https://biospectrumindia.com/news/95/12751/cipla-receives-final-approval-for-generic-version-of-adcirca.html Thu, 07 Feb 2019 09:20:00 +0530 Cipla Limited has announced that it has received final approval for its Abbreviated New Drug Application (ANDA) for Tadalafil Tablets 20mg from the United States Food and Drug Administration (US FDA). Cipla’s Tadalafil Tablets 20mg is AB-rated generic therapeutic equivalent version of Eli Lilly & Co.’s Adcirca. It is a phosphodiesterase 5 (PDE5) inhibitor indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise ability. According to IQVIA (IMS Health), Adcirca® and its generic equivalents had US sales of approximately $490M for the 12-month period ending November 2018. The product is available for shipping immediately.   ]]> <![CDATA[Glenmark Pharma signs an agreement with Grandpharma ]]> https://biospectrumindia.com/news/95/12745/glenmark-pharma-signs-an-agreement-with-grandpharma-.html https://biospectrumindia.com/news/95/12745/glenmark-pharma-signs-an-agreement-with-grandpharma-.html Wed, 06 Feb 2019 14:30:00 +0530 Glenmark Pharmaceuticals has announced that its Swiss subsidiary, Glenmark Specialty S.A., has entered into an exclusive licensing agreement with Grandpharma (China) Co. Ltd. for commercializing its novel nasal spray Ryaltris in China. The agreement with Grandpharma is Glenmark’s third regional licensing deal for Ryaltris. Glenmark has already signed licensing deals for commercializing Ryaltris in Australia, New Zealand and South Korea. Ryaltris [olopatadine hydrochloride (665 mcg) and mometasone furoate (25 mcg)], developed by Glenmark, is a novel, investigational, fixed-dose combination nasal spray of an anti-histamine and a steroid, indicated for treatment of symptoms associated with seasonal allergic rhinitis (SAR) in patients over 12 years of age. Under the terms of the agreement, Glenmark will be responsible to manufacture and supply Ryaltris, while Grandpharma will be responsible for regulatory filing and commercialization of Ryaltris in China. Glenmark will receive an upfront payment, regulatory filing, regulatory approval and commercial milestone payments as well as royalties from Grandpharma for Ryaltris. Glenn Saldanha, Chairman and Managing Director of Glenmark Pharmaceuticals said, “We are happy to partner with Grandpharma in China as its product portfolio complements well with Ryaltris and this partnership gives us an opportunity to tap into one of the largest pharmaceutical markets in the world. This step is aligned with our vision to make Ryaltris the first global brand of Glenmark through launches in multiple markets across the globe.” In May 2018, Glenmark filed a New Drug Application (NDA) for Ryaltris with the US Food and Drug Administration (US FDA), which is currently under review with the regulator. Glenmark plans to commercialize Ryaltris in various markets globally.   ]]> <![CDATA[Lupin launches drug to treat OCD]]> https://biospectrumindia.com/news/95/12736/lupin-launches-drug-to-treat-ocd.html https://biospectrumindia.com/news/95/12736/lupin-launches-drug-to-treat-ocd.html Wed, 06 Feb 2019 09:00:00 +0530 Pharma major Lupin recently announced the launch of Clomipramine Hydrochloride Capsules USP, 25 mg, 50 mg, and 75 mg having received an approval from the United States Food and Drug Administration (FDA) earlier. Lupin’s Clomipramine Hydrochloride Capsules USP, 25 mg, 50 mg, and 75 mg is the generic equivalent of SPECGX LLC’s Anafranil Capsules, 25 mg, 50 mg, and 75 mg. It is indicated for the treatment of obsessions and compulsions in patients with Obsessive-Compulsive Disorder (OCD). Clomipramine Hydrochloride Capsules USP, 25 mg, 50 mg, and 75 mg had annual sales of $96.2 million in the US (IQVIA MAT December 2018). ]]> <![CDATA[Indian Cancer Society & AstraZeneca launch early cancer screening programme for women nationwide]]> https://biospectrumindia.com/news/95/12725/indian-cancer-society-astrazeneca-launch-early-cancer-screening-programme-for-women-nationwide.html https://biospectrumindia.com/news/95/12725/indian-cancer-society-astrazeneca-launch-early-cancer-screening-programme-for-women-nationwide.html Tue, 05 Feb 2019 11:35:00 +0530 Indian Cancer Society and AstraZeneca Pharma India Limited has announced the launch of a nationwide cancer awareness initiative - Cancer Screening for Women. Under this programme, free, specialized cancer-screening will be conducted across the country for women from underprivileged families. These screening camps will focus on prevalent cancers such as oral, cervical and breast and will follow a rigorous process to link the suspect cases with health care facilities for further management. The programme also aims to raise awareness about risk factors, symptoms, removing stigma, and promoting healthy lifestyle for cancer prevention. The first screening camp to mark this launch was held on World Cancer Day at Indian Cancer Society, Mumbai, where over 100 women were screened. Mr. Naveen Kshatriya, Honorary Secretary & Managing Trustee, of the Indian Cancer Society said, “With the increasing incidence of cancer cases in women, there is an urgent need to raise awareness about early cancer detection at grass-roots level. With this initiative, we aim to enable people to stay ahead of cancer through early detection and timely treatment.’’ Commenting on the occasion, Mr. Gagan Singh, Country President and Managing Director, AstraZeneca Pharma India Limited said, “We are pleased to partner with Indian Cancer Society and other partners to achieve our shared vision of curing cancer through early detection. Women’s health is integrally linked to access to available resources and we believe that opportunistic screening with a robust framework to link them to the healthcare system is an important pathway to address this challenge” As part of Phase 1 of this programme, around 4000 women beneficiaries from vulnerable section of society will be screened in identified high priority district areas of Maharashtra, Tamil Nadu, Kerala and Karnataka with the help of mobile detection units with qualified technicians across urban and rural areas. In Phase 2, the specialised screening camps will be expanded to states in North & North - East India. The entire programme will run over the coming years. We thank our chief Guest Shri Vishwanath Mahadeshwar The Mayor of Brihanmumbai Municipal Corporation , Mumbai and Shri Kalidas Kolambkar MLA, Wadala Constituency. Indian Cancer Society (ICS) is India's first voluntary, non-profit, National Organization for  Awareness, Screening, Treatment Support, Survivorship and Rehabilitation, of those affected with cancer, Cancer Registry. ICS was established in 1951 by Dr. D.J. Jussawalla and Mr. Naval Tata and since then Indian Cancer Society has been doing sterling work in fighting cancer across India. ICS is actively involved with Tata Trusts, Tata Memorial Hospital, Govt of Maharashtra and various local organisations in executing awareness, screening, research and education, treatment support, survivorship and rehabilitation of cancer patient. AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three therapy areas - Oncology, Cardiovascular, Renal & Metabolism and Respiratory. AstraZeneca India was established in 1979 and is marking its 40th year of long standing commitment to India. It is headquartered at Bengaluru, Karnataka. AstraZeneca India has a workforce of over 1200 employees across the country committed to deliver great medicines to patients through innovative science and global excellence in development and commercialization. ]]> <![CDATA[CORE Diagnostics supports walk-a-thon against Cancer ]]> https://biospectrumindia.com/news/95/12719/core-diagnostics-supports-walk-a-thon-against-cancer-.html https://biospectrumindia.com/news/95/12719/core-diagnostics-supports-walk-a-thon-against-cancer-.html Mon, 04 Feb 2019 15:55:00 +0530 CanSupport , a WHO awarded organization providing free palliative and supportive care services to cancer patients since 1996 organized its 12th annual walk-a-thon called Walk for Life: Stride against cancer supported by ONGC, CORE Diagnostics, Boeing International Corporation India Private Limited and Max India Foundation. The walk was organized to draw public attention to the growing and menacing presence of cancer in our country, to show support for cancer patients, honor those lost to cancer and raise funds for CanSupport’s free of charge home care services to people with cancer in Delhi/NCR and Amritsar. Ms Harmala Gupta, Founder-President, CanSupport gave the welcome address followed by a speech by Ms. Jeannie Mulford wife of Ex US Ambassador to India, a breast cancer survivor. Guest of honour Mrs. Gursharan Kaur flagged off the Walk. Dr. A.P Maheshwari, DG Bureau of Police Research & Development; Ms. Mary Carlson, Deputy Chief Of Mission, US Embassy; Mr Manoj Barthwal, GM-HR, ONGC; Ms. Mohini Daljeet Singh, CEO, Max India Foundation and Ms. Praveena Yagambhatt, Leader for Boeing Global Engagement India were some of the distinguished guests at the Walk. This year, the Walk saw the youth taking the lead and individuals from more than 30 Corporates, Embassy, 50 Schools and Colleges Institutes came forward to show solidarity with those suffering from cancer and remove the stigma attached to cancer. The Walk also witnessed participation from the Harley Davidson Rider Group who rode with cancer survivors to show their support. The Band from BSF, Drummers from Djembe Circle and Zumba performance by Fantezy group kept the walkers entertained as they walked down Rajpath, the route of the walk. Ms. Harmala Gupta, Founder-President CanSupport said “The huge turnout at CanSupport’s Walk for Life and the variety of participants are a reminder that cancer does not recognise boundaries of country, class, age or gender. What unites us all today is our determination to stand shoulder to shoulder and not allow cancer to crush our spirit” Ms. Zoya Brar, Founder & Managing Director, CORE Diagnostics said, “We are grateful and privileged to support CanSupport’s initiative to spread positivity and celebrate cancer survivorship. In order to give back to society, we believe that such first-hand partnerships can immensely transform the state of cancer awareness, care and support in our country. Being so closely entwined with cancer care, we are happy to associate with a cause at this scale to spread much-needed awareness about early detection and prevention to save more lives. We will continue to walk and work for the community this way.” CORE Diagnostics is a high-end clinical laboratory focused on next generation diagnostics for disease stratification and therapy selection. The company focuses on bringing the most advanced testing techniques and expertise to India and is the destination for all of India’s high-end diagnostic needs. CORE Diagnostics has a rich menu of high-end tests; provides a second opinion on every test from a global panel of pathologists; and has the shortest turnaround time. The company’s test offerings are in the areas of cardiology, oncology, reproductive disorders, endocrinology, and infectious diseases. CORE Diagnostics also has international roots in the United States, Dubai, Africa and various countries in South Asia. ]]> <![CDATA[Alkermes announces rejection of ALKS 5461 NDA]]> https://biospectrumindia.com/news/95/12707/alkermes-announces-rejection-of-alks-5461-nda.html https://biospectrumindia.com/news/95/12707/alkermes-announces-rejection-of-alks-5461-nda.html Mon, 04 Feb 2019 11:20:00 +0530  Alkermes plc has announced that it received a Complete Response Letter (CRL) from the U.S. Food and Drug Administration (FDA) regarding its New Drug Application (NDA) for ALKS 5461 for the adjunctive treatment of major depressive disorder (MDD). According to the DSM-5(Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition), major depressive disorder (MDD) is a condition in which patients exhibit depressive symptoms, such as a depressed mood or a loss of interest or pleasure in daily activities consistently for at least a two-week period, and demonstrate impaired social, occupational, educational or other important functioning. An estimated 16.2 million people in the U.S. suffered from MDD in 2016,1 the majority of whom may not adequately respond to initial antidepressant therapy. The CRL states that the FDA is unable to approve the ALKS 5461 NDA in its present form and is requesting additional clinical data to provide substantial evidence of effectiveness of ALKS 5461 for the adjunctive treatment of MDD. Alkermes plans to meet with the FDA to discuss the contents of the CRL and potential next steps for ALKS 5461. This interaction with the Agency will inform whether there is a viable path forward for the ALKS 5461 program. The NDA submission for ALKS 5461 was based on results from a clinical efficacy and safety package with data from more than 30 clinical trials and more than 1,500 patients with MDD. Throughout the clinical development program, ALKS 5461 demonstrated a consistent profile of antidepressant activity, safety and tolerability in the adjunctive treatment of MDD. ALKS 5461 is a proprietary, investigational, once-daily oral medicine that acts as an opioid system modulator and represents a novel mechanism of action for the adjunctive treatment of major depressive disorder (MDD) in patients with an inadequate response to standard antidepressant therapies. ALKS 5461 is a fixed-dose combination of buprenorphine, a partial mu-opioid receptor agonist and kappa-opioid receptor antagonist, and samidorphan, a mu-opioid receptor antagonist. ]]> <![CDATA[Lupin announces launch of NaMuscla]]> https://biospectrumindia.com/news/95/12704/lupin-announces-launch-of-namuscla.html https://biospectrumindia.com/news/95/12704/lupin-announces-launch-of-namuscla.html Mon, 04 Feb 2019 10:40:00 +0530 Lupin has announced the launch of NaMuscla® (mexiletine) in Germany and the United Kingdom (UK). NaMuscla® is approved across the European Union (EU) for the symptomatic treatment of myotonia in adults with non-dystrophic myotonic (NDM) disorders. These disorders are a group of rare, inherited neuromuscular conditions in which myotonia, the inability to relax muscles following voluntary contraction, is the most prominent clinical symptom. NaMuscla® reduces myotonia symptoms in adult patients, resulting in a significant improvement in patient quality-of-life and other functional outcomes. The launch of NaMuscla® in Germany and the UK follows the European Commission’s approval of the product on 18 December 2018. NaMuscla®, designated an Orphan Drug by the European Medicines Agency (EMA), is the first treatment to be licensed across the EU for the symptomatic treatment of myotonia in adults with NDM disorders. The product will be commercialized in Germany by Hormosan Pharma GmbH, a full subsidiary of Lupin Ltd., and in the UK by Lupin Healthcare (UK) Ltd. Thierry Volle, President EMEA, Lupin said, “We are delighted to be able to provide patient and market access to NaMuscla® in Germany and the UK. NaMuscla® is the first licensed therapy for myotonia across the EU and offers an effective treatment option for patients living with this life-altering symptom. We look forward to additional launches for patients in other EU territories through 2019 and 2020.” Lupin has ongoing partnering discussions for the commercialization of NaMuscla® in European territories outside of Germany and the UK.   ]]> <![CDATA[Dermozone to launch its +dalethyne based skincare products in India]]> https://biospectrumindia.com/news/95/12696/dermozone-to-launch-its-dalethyne-based-skincare-products-in-india.html https://biospectrumindia.com/news/95/12696/dermozone-to-launch-its-dalethyne-based-skincare-products-in-india.html Fri, 01 Feb 2019 15:10:00 +0530 Indonesia-based Dermozone, a renowned wound healing and skincare products company, has announced its plans to shortly launch in India a total of five ‘+dalethyne’ based skincare products under its two product categories i.e. The Dermozone Acne Solution Category which will have three products namely Dermozone Acne Wax, Dermozone Face Wash & Dermozone Face Scrub and the Dermozone Baby category which will have two products namely Dermozone Baby Wax and Dermozone Baby Massage Oil. Dermozone is in the process of identifying potential organizations in India with whom it will enter into a partnership for the entire marketing and sales of the above mentioned five skincare products. The company had recently announced the India launch of its Dermozone range of ‘+dalethyne’ based wound care products that would be a new hope for unsolved chronic, acute, and burn wounds, which are now increasing rapidly in India. Dermozone has partnered with Delhi-based Alniche Life Sciences Pvt. Ltd., a specialty healthcare company, to handle the complete marketing and sales of the wound care products. +dalethyne, a breakthrough in medicinal science and the key ingredient of the complete range of Dermozone’s wound care and skincare products was invented after 18 years of untiring research since 2000 by Kayapan Satya Dharshan, the Founder and Chairman of Dermozone, +dalethyne, a clinically tested compound, is obtained from a process of fatty acid segregation of extra virgin olive oil. “+dalethyne has proven effect of anti-microbial, fungicidal and antiviral quality with deep skin-penetrable quality. Investigations have revealed that +dalethyne reduces inflammation and accelerates wound healing,” said Kayapan Satya Dharshan. “+dalethyne has been patented in several countries under my name and this patent is certified as a Novel Innovation Patent in Geneva. All Dermozone products use the power of goodness of +dalethyne to heal any skin related issue without any side-effects,” he further added.    ]]> <![CDATA[Natco Pharma submits ANDA for Ibrutinib generic]]> https://biospectrumindia.com/news/95/12693/natco-pharma-submits-anda-for-ibrutinib-generic.html https://biospectrumindia.com/news/95/12693/natco-pharma-submits-anda-for-ibrutinib-generic.html Fri, 01 Feb 2019 11:40:00 +0530 Natco Pharma Limited has announced submission of an Abbreviated New Drug Application (ANDA) containing a paragraph IV certification with the U.S. Food and Drug Administration (FDA) for generic version of Ibrutinib Tablets of 140mg, 280mg, 420mg and 560mg strength (proposed generic equivalents to Imbruvica® Tablets). NATCO and its co-development & marketing partner, Alvogen Pine Brook LLC, USA, believe that the ANDA is possibly sole first-to-file based on the ANDA filing dates. According to the company, the ANDA may be eligible for 180 days of marketing exclusivity at the time of potential launch of the product under certain circumstances. In the United States Imbruvica® brand is owned and marketed by Pharmacyclics LLC and Janssen Biotech, Inc. Imbruvica® had U.S. Sales of approximately US$ 2.6 Billion for twelve months ending September, 2018, according to data from IQVIA. As per the last tracked prescription sales, almost 83% of the sales contribution has come from the above mentioned tablet dosage forms. ]]> <![CDATA[Strides to acquire full stake in Vensun Pharma]]> https://biospectrumindia.com/news/95/12660/strides-to-acquire-full-stake-in-vensun-pharma.html https://biospectrumindia.com/news/95/12660/strides-to-acquire-full-stake-in-vensun-pharma.html Wed, 30 Jan 2019 09:00:00 +0530 Strides Pharma Science Limited has announced that its step down subsidiary Strides Pharma, Inc has entered into an arrangement to acquire 100 per cent stake in Vensun Pharmaceuticals, Inc, a US-based Generics Company. The board of directors of Strides have taken the same on record. Vensun was founded in 2011 with an asset-light partner-driven business model to develop products for the US generics markets. It entered into a partnership with the erstwhile Shasun Pharmaceuticals Limited for a range of difficult to develop products on a 50:50 profit share arrangement. Vensun has a strategic focus on niche ANDAs with a portfolio of 16 commercialized ANDAs, four of which are partnered with Strides and constitute a significant part of Vensun’s current revenues of US$ ~17 Million. Its portfolio also comprises additional 13 filed ANDAs which includes Strides Competitive Generic Therapy (CGT) designated product with US$ 400 Million market opportunity. Vensun also has a development pipeline with two other partners for ten products.   ]]> <![CDATA[LANXESS expands range of membranes for reverse osmosis]]> https://biospectrumindia.com/news/95/12652/lanxess-expands-range-of-membranes-for-reverse-osmosis.html https://biospectrumindia.com/news/95/12652/lanxess-expands-range-of-membranes-for-reverse-osmosis.html Tue, 29 Jan 2019 14:30:00 +0530 Specialty chemicals company LANXESS is expanding its range of membrane elements for reverse osmosis (RO). The new Lewabrane HP (high performance) series comprises elements that consist of an enhanced brackish water membrane to serve applications in which high rejection and energy efficiency are important. Using the new types in combination with monodisperse Lewatit ion exchange resins provides high quality produced water at lower operational cost. With an average salt rejection of 99.7 percent (at 2,000 ppm NaCl; 225 psi) and high permeability, the new product types are a further development of the high cross-linked polyamide membrane which LANXESS launched in 2012. Controlling the degree of polyamide cross-linking during production process provides a small effective “pore size” that results in high rejection of solutes, regardless their charge. “By optimization of the process, the flux could be improved without compromising permeate quality. Therefore, high rejection, even at changing feed parameters like pH or salinity, can be achieved at high flux rate,” explains Dr. Jens Lipnizki, head of Technical Marketing Membranes in the Liquid Purification Technologies business unit. LANXESS is showcasing its new Lewabrane HP membrane elements for the first time at the Membrane Technology Conference & Exposition, hosted by the American Membrane Technology Association (AMTA) and the American Water Works Association (AWWA) in New Orleans (LA), USA, February 25 to 28, 2019. Efficient even at changing conditions Reverse osmosis is used for desalination and purification of water and has been growing rapidly in industrial, municipal and waste water reuse applications, where parameters can change quickly. The Lewabrane HP types ensure high rejection of critical ions even at changing temperature and pH levels. Depending on the application, different species are rated as critical. For boiler feed water silica is critical, while wastewater applications focus on nitrate or organics. “In a number of industries high salt rejection combined with high energy efficiency is useful. Especially if the RO process is designed in combination with another separation process like ion exchange. The benefit is based on the lower applied pressure and on the higher rejection, which lead to longer cycle times of the ion exchange units,” says Lipnizki. Therefore, the typical applications are combined processes like production of boiler feed water for power generation, zero liquid discharge processes (ZLD), or production of ultrapure water. Yet, the product can also be used in innovative processes like closed circuit reverse osmosis (CCRO), in which the feed water composition changes with each cycle, the constant rejection is an important benefit of the new Lewabrane HP type. Well designed LewaPlus, the engineering tool developed by LANXESS, enables easy and reliable design of water treatment facilities. The software allows designing ion exchange and RO membrane based plants separately as well as combined systems. It pools the knowledge and experience of LANXESS in both technologies and is giving plant designers a recommendation on how they can best arrange the membrane components to their needs. The latest 2.0.9 version already includes the new Lewabrane HP types. ]]> <![CDATA[J&J announces USFDA approval of IMBRUVICA]]> https://biospectrumindia.com/news/95/12643/jj-announces-usfda-approval-of-imbruvica.html https://biospectrumindia.com/news/95/12643/jj-announces-usfda-approval-of-imbruvica.html Tue, 29 Jan 2019 10:25:00 +0530 The Janssen Pharmaceutical Companies of Johnson & Johnson has announced the U.S. Food and Drug Administration (FDA) approval of IMBRUVICA® (ibrutinib) in combination with obinutuzumab in treatment-naïve patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL), the most common form of leukemia in adults. This is the first approval for a non-chemotherapy combination regimen for treatment-naïve patients with CLL/SLL, and marks the tenth FDA approval for IMBRUVICA since its U.S. launch in November 2013. The approval expands the label for IMBRUVICA in frontline CLL/SLL beyond its use as a monotherapy to include combination use with obinutuzumab. This approval is based on results from the Phase 3 iLLUMINATE study. Craig Tendler, Vice President, Clinical Development and Global Medical Affairs, Janssen Research & Development said, “This label update builds upon the established efficacy and safety of IMBRUVICA in the frontline treatment of patients with CLL/SLL, as a monotherapy or in combination with other treatments. This milestone represents our continued commitment to develop IMBRUVICA-based, non-chemotherapy regimens to address the clinical needs of patients living with CLL/SLL.” IMBRUVICA, a Bruton's tyrosine kinase (BTK) inhibitor, is jointly developed and commercialized by Janssen Biotech, Inc. and Pharmacyclics LLC, an AbbVie company.   ]]> <![CDATA[Dr Reddy's receives FDA approval for nasal spray in US]]> https://biospectrumindia.com/news/95/12630/dr-reddys-receives-fda-approval-for-nasal-spray-in-us.html https://biospectrumindia.com/news/95/12630/dr-reddys-receives-fda-approval-for-nasal-spray-in-us.html Mon, 28 Jan 2019 15:35:00 +0530 Dr. Reddy’s Laboratories Ltd. and its subsidiary, Promius Pharma, LLC have announced the approval of TOSYMRA (previously known as DFN-02) by the U.S. Food and Drug Administration (FDA). TOSYMRA is indicated for the acute treatment of migraine with or without aura in adults. TOSYMRA is the latest product to join the Promius Pharma acute migraine treatment portfolio. The company is working toward commercialization of this product. “We are excited about the approval of TOSYMRA. This approval affirms our ability to develop well-differentiated products to meet the unmet needs of patients with migraine and HCPs treating them,” said G.V. Prasad, Co-Chairman and CEO, Dr. Reddy’s Laboratories. According to Dr. Anil Namboodiripad, PhD, President, Promius Pharma, “TOSYMRA nasal spray is formulated using a proprietary novel excipient known as Intravail® to achieve blood levels similar to a 4-mg sumatriptan subcutaneous injection, resulting in rapid onset of action. Independent research shows that 26% to 40% of migraine patients are not optimally controlled with their current treatment. For patients who suffer from the debilitating and disruptive effects of migraine, there continues to be a need for reliable and efficacious treatment options. At Promius, we are committed to developing new ways of improving patient experiences. TOSYMRA is a mist-like nasal spray that acts rapidly and is well tolerated.” ]]> <![CDATA[Natco Pharma invests Rs 100Cr in agrochemical space]]> https://biospectrumindia.com/news/95/12626/natco-pharma-invests-rs-100cr-in-agrochemical-space.html https://biospectrumindia.com/news/95/12626/natco-pharma-invests-rs-100cr-in-agrochemical-space.html Mon, 28 Jan 2019 13:40:00 +0530 Natco Pharma Limited has initiated work on green-field manufacturing facilities for producing Niche Agrichemical products in the Nellore District of Andhra Pradesh. These facilities will manufacture both Agrichemical Technical and Formulation products. Natco strongly believes that its pharma strength in chemistry coupled with an acumen towards selection of niche molecules would differentiate itself in the Agrichemical space as well. Natco expects the facilities in Nellore district to be commissioned by end of 2019 with a total capital expenditure of Rs 100 crores. ]]> <![CDATA[Olon S.p.A. expands globally by acquiring Capua BioServices]]> https://biospectrumindia.com/news/95/12625/olon-s-p-a-expands-globally-by-acquiring-capua-bioservices.html https://biospectrumindia.com/news/95/12625/olon-s-p-a-expands-globally-by-acquiring-capua-bioservices.html Mon, 28 Jan 2019 12:40:00 +0530 Olon S.p.A., a world leading Active Pharmaceutical Ingredients (API) contract development and manufacturing organization (CDMO) and generics supplier, has announced the acquisition of Capua BioServices S.p.A., a global provider of CDMO services in the field of microbial fermentation, as part of a continuing expansion of its global footprint. "Following the acquisition of Ricerca Biosciences' Chemical Division in mid-2017 and the manufacturing site in Mahad (India), announced in Q3 2018 with closing in Q1 2019, we have now completed a further step in our strategic plan. With this acquisition Olon has successfully finalized his 3 years' development plan,"said, Paolo Tubertini, CEO of Olon. Capua BioServices is a global provider of high-quality services in the field of custom microbial process development and manufacturing. Capua BioServices offers dedicated solutions for proteins, specialty small molecules and microorganisms for applications in pharma, food, feed and other bio-industrial markets. The site is beta-lactam free with a total fermentation capacity of about 1.400 m3, with approximately 230 employees. Over the past 60 years, the company has built a track record based on extensive experience in working with a variety of bacterial, yeast and fungal systems. No impact on jobs is planned and Olon intends to invest in the site and pursue business development opportunities to optimize the plant's utilization and expand its customer base. ]]> <![CDATA[Aurobindo recalls nearly 5 lakh bottles of blood pressure drug in US]]> https://biospectrumindia.com/news/95/12623/aurobindo-recalls-nearly-5-lakh-bottles-of-blood-pressure-drug-in-us.html https://biospectrumindia.com/news/95/12623/aurobindo-recalls-nearly-5-lakh-bottles-of-blood-pressure-drug-in-us.html Mon, 28 Jan 2019 11:55:00 +0530 Drug firm Aurobindo is recalling close to 5 lakh bottles of blood pressure lowering drugs in the US after the American health regulator found certain deviations from Current Good Manufacturing Practice (CGMP) regulations. According to the latest Enforcement Report by the the US Food and Drug Administration (USFDA), the Hyderabad-based Aurobindo Pharma is recalling 1,62,301 bottles of Amlodipine and Valsartan Tablets, 3,12,095 bottles of Valsartan and Hydrochlorothiazide tablets and 20,604 bottles of Valsartan tablets in the US. The drug firm is recalling the drugs after FDA lab confirmed presence of an impurity N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product, above the interim acceptable daily intake level of 0.083 parts per million. The company's US-based arm Aurobindo Pharma USA Inc is recalling the lots. The USFDA has classified it as a Class-II recall, which is initiated in a "situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote". Another drug maker Lupin is voluntarily recalling 7,215 bottles of Cephalexin for Oral Suspension USP, used to treat a wide variety of bacterial infections, in the US due CGMP deviations. This story has been published from a wire agency without modifications to the text.   ]]> <![CDATA[USFDA completes inspection at Lupin’s Indore facility]]> https://biospectrumindia.com/news/95/12618/usfda-completes-inspection-at-lupins-indore-facility.html https://biospectrumindia.com/news/95/12618/usfda-completes-inspection-at-lupins-indore-facility.html Mon, 28 Jan 2019 10:40:00 +0530 United States Food and Drug Administration (USFDA) has completed inspection at Lupin’s Pithampur Unit-2 (Indore) facility. The inspection was carried out between January 14 and January 25, 2019. The inspection at Pithampur Unit-2 (Indore) closed with 6 observations.  Lupin is an innovation led transnational pharmaceutical company developing and delivering a wide range of branded & generic formulations, biotechnology products and APIs globally ]]> <![CDATA[Cipla receives approval for pfizer's Depo-Provera]]> https://biospectrumindia.com/news/95/12616/cipla-receives-approval-for-pfizers-depo-provera.html https://biospectrumindia.com/news/95/12616/cipla-receives-approval-for-pfizers-depo-provera.html Mon, 28 Jan 2019 09:20:00 +0530 Global pharma company, Cipla has announced that it has received final approval for its Abbreviated New Drug Application (ANDA) for Medroxyprogesterone Injectable, 150mg/mL from the United States Food and Drug Administration (US FDA). Cipla’s Medroxyprogesterone Injectable, 150mg/mL is AB-rated generic therapeutic equivalent version of Pfizer’s Depo-Provera. It is a progestin indicated only for the prevention of pregnancy. According to IQVIA (IMS Health), Depo-Provera and its generic equivalents had US sales of approximately $159M for the 12-month period ending November 2018. ]]> <![CDATA[Basilea announces collaboration with Roche]]> https://biospectrumindia.com/news/95/12604/basilea-announces-collaboration-with-roche.html https://biospectrumindia.com/news/95/12604/basilea-announces-collaboration-with-roche.html Fri, 25 Jan 2019 12:15:00 +0530 Commercial stage biopharma company, Basilea Pharmaceutica has announced that it entered into a collaboration with Roche to explore a combination of Basilea's derazantinib and Roche's PD-L1-blocking immune-checkpoint inhibitor atezolizumab (Tecentriq®) in patients with urothelial cancer. Basilea expects to start a biomarker-driven multi-cohort phase 1/2 study mid-2019. Dr. Marc Engelhardt, Chief Medical Officer of Basilea, said, "We are very pleased with this collaboration. This is an important study as it explores a novel targeted treatment approach that addresses the high medical need of patients with urothelial cancer." He also added, "The combination of derazantinib and atezolizumab is based on a sound scientific rationale. In addition to its effects on FGFR kinases, derazantinib also inhibits the colony-stimulating factor-1-receptor kinase (CSF1R). CSF1R inhibition has the potential to enhance the response to atezolizumab's immune-checkpoint inhibition. The combination of inhibiting FGFR while, at the same time, enhancing T cell-mediated antitumor effects through CSF1R inhibition is potentially a promising new treatment approach in patients with urothelial cancer." The planned study will assess the safety, tolerability and efficacy of the derazantinib-atezolizumab combination in patients with advanced urothelial cancer and confirmed FGFR genomic aberrations. Basilea will be the sponsor of the study and Roche will provide clinical supply of atezolizumab for the study. Urothelial cancer is the sixth most common cancer in the U.S. These cancers start in the urothelial cells that line the inside of the bladder. 80,000 new cases of bladder cancer have been estimated in the U.S. for 2017. Up to 20 percent of patients will have muscle-invasive disease and present with or will later develop metastases. For patients with metastatic disease, outcomes can be poor due to the often rapid progression of the tumor and the lack of efficacious treatments, especially in relapsed or refractory disease.   ]]> <![CDATA[Dr Reddy’s launches sedation drug in US market]]> https://biospectrumindia.com/news/95/12595/dr-reddys-launches-sedation-drug-in-us-market.html https://biospectrumindia.com/news/95/12595/dr-reddys-launches-sedation-drug-in-us-market.html Fri, 25 Jan 2019 10:40:00 +0530 Dr. Reddy’s Laboratories Ltd. has announced the launch of Propofol Injectable Emulsion, USP, a therapeutic equivalent generic version of DIPRIVAN (propofol) Injectable Emulsion, USP, approved by the U.S. Food and Drug Administration (USFDA). Propofol injectable emulsion is an intravenous general anesthetic and sedation drug for use in the induction and maintenance of anesthesia, or sedation. The Diprivan brand and generic had U.S. sales of approximately $310 million MAT for the most recent twelve months ending in November 2018 according to IMS Health. ]]> <![CDATA[Dr. Reddy's announces the launch of sedation drug in US ]]> https://biospectrumindia.com/news/95/12593/dr-reddys-announces-the-launch-of-sedation-drug-in-us-.html https://biospectrumindia.com/news/95/12593/dr-reddys-announces-the-launch-of-sedation-drug-in-us-.html Fri, 25 Jan 2019 10:30:00 +0530 Dr. Reddy’s Laboratories Ltd. has announced the launch of Propofol Injectable Emulsion, USP, a therapeutic equivalent generic version of DIPRIVAN (propofol) Injectable Emulsion, USP, approved by the U.S. Food and Drug Administration (USFDA). As per the company statement, “Dr. Reddy’s is committed to providing affordable and innovative medicines for healthier lives. To that end, Dr. Reddy’s neither condones nor supports the off-label use or misuse of its drugs. In the strongest possible terms, Dr. Reddy’s objects to the use of any of its products to facilitate or otherwise aid lethal injections. Consistent with this position, Dr. Reddy’s uses distribution controls to market Propofol Injectable Emulsion, USP.” The statement also says that, “Dr. Reddy’s will not accept orders from correctional facilities and prison systems whose intended use of the product is to aid in lethal injection. We require the same commitment from our wholesalers and distributors.” The Diprivan brand and generic had U.S. sales of approximately $310 million MAT for the most recent twelve months ending in November 2018 according to IMS Health. Dr. Reddy’s Propofol Injectable Emulsion, USP is available in 10 mg/mL vials for Single Patient Use Only. Propofol injectable emulsion is an intravenous general anesthetic and sedation drug for use in the induction and maintenance of anesthesia, or sedation. ]]> <![CDATA[PHARMASEAL launches clinical trial platform for integrated governance]]> https://biospectrumindia.com/news/95/12586/pharmaseal-launches-clinical-trial-platform-for-integrated-governance.html https://biospectrumindia.com/news/95/12586/pharmaseal-launches-clinical-trial-platform-for-integrated-governance.html Thu, 24 Jan 2019 14:50:00 +0530 PHARMASEAL provides clinical trial management platform and governance solutions to enter the market, has launched Engility™ CTMS, the first product to be released from its Engility B2B platform. PHARMASEAL has industry expertise, innovative thinking and advanced automation to build and operate an integrated enterprise platform which allows biopharmaceutical and medical device companies to manage all of their clinical trials effectively. With a focus on usability and rapid implementation, this innovative new generation clinical trial management system (CTMS) has been designed to increase the level of governance and control that organisations demand from their management systems to enable effective oversight of their clinical trials. A key challenge to overcome in the design was to optimise the cost of software validation so that new innovations can be introduced easily for the benefit of customers. Engility CTMS is engineered for change and benefits from extensive automation to deliver new features in a regulated industry, faster than current products. With an intuitive interface and flexible cloud architecture, biopharmaceutical and medical device companies of all sizes can leverage affordable enterprise technology to fit their particular organisation model.   ]]> <![CDATA[Cadila collaborates with Norwegian startup for unique heart treatment ]]> https://biospectrumindia.com/news/95/12585/cadila-collaborates-with-norwegian-startup-for-unique-heart-treatment-.html https://biospectrumindia.com/news/95/12585/cadila-collaborates-with-norwegian-startup-for-unique-heart-treatment-.html Thu, 24 Jan 2019 13:05:00 +0530 The Norwegian start-up company SERCA Pharmaceuticals has entered into a unique agreement with the Indian pharmaceutical company Cadila Pharmaceuticals. The agreement is about developing a new and better treatment for patients afflicted with heart attack. The signing of the agreement took place in New Delhi recently in connection with the official state visit to Prime Minister Erna Solberg. In the deal, Cadila Pharmaceuticals will use its development organization to make part of the development of a new treatment for patients afflicted with heart attack, which SERCA Pharmaceuticals can advance to global markets. The new drug is based on an invention made by Professor Kjetil Taskén and co-workers at the University of Oslo and Oslo University Hospital, and SERCA Pharmaceuticals was established by the university's TTO, Inven2. SERCA Pharmaceuticals will develop a drug treatment for injuries that occur when treating myocardial infarction. ]]> <![CDATA[Glenmark receives tentative ANDA approval for generic QUDEXY]]> https://biospectrumindia.com/news/95/12582/glenmark-receives-tentative-anda-approval-for-generic-qudexy.html https://biospectrumindia.com/news/95/12582/glenmark-receives-tentative-anda-approval-for-generic-qudexy.html Thu, 24 Jan 2019 10:20:00 +0530 Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted tentative approval by the United States Food & Drug Administration (U.S. FDA) for Topiramate Extended-Release Capsules, 25 mg, 50 mg, 100 mg, 150 mg, and 200 mg. It is a generic version of QUDEXY®1 XR Extended-Release Capsules, 25 mg, 50 mg, 100 mg, 150 mg, and 200 mg, of UpsherSmith Laboratories, LLC. According to IQVIATM sales data for the 12 month period ending November 2018, the QUDEXY® XR Extended-Release Capsules, 25 mg, 50 mg, 100 mg, 150 mg, and 200 mg market2 achieved annual sales of approximately $84.0 million. Glenmark’s current portfolio consists of 148 products authorized for distribution in the U.S. marketplace and 54 ANDA’s pending approval with the USFDA. In addition to these internal filings, Glenmark continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio. ]]> <![CDATA[Lupin gets USFDA nod for hypothyroidism treatment drug]]> https://biospectrumindia.com/news/95/12581/lupin-gets-usfda-nod-for-hypothyroidism-treatment-drug.html https://biospectrumindia.com/news/95/12581/lupin-gets-usfda-nod-for-hypothyroidism-treatment-drug.html Wed, 23 Jan 2019 17:50:00 +0530 Drug firm Lupin has  said that it has received approval from the US health regulator to market Levothyroxine Sodium tablets used for treatment of hypothyroidism. The company has received an approval from the United States Food and Drug Administration (USFDA) to market the tablets in the strengths of 25 microgram (mcg), 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg, 200 mcg, and 300 mcg, Lupin said. The product is a generic version of AbbVie Inc's Synthroid tablets in the same strengths, it added. According to IQVIA MAT September 2018 data, Levothyroxine Sodium tablets had an annual sale of about USD 2.5 billion in the US market, Lupin said. The tablets are indicated for hypothyroidism and as an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer, it added. ]]> <![CDATA[FDA accepts Roche’s supplemental biologics license application for Tecentriq ]]> https://biospectrumindia.com/news/95/12571/fda-accepts-roches-supplemental-biologics-license-application-for-tecentriq-.html https://biospectrumindia.com/news/95/12571/fda-accepts-roches-supplemental-biologics-license-application-for-tecentriq-.html Wed, 23 Jan 2019 13:10:00 +0530 Roche announced that the US Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) for Tecentriq® (atezolizumab) in combination with Abraxane® [albumin-bound paclitaxel; nab-paclitaxel]) and carboplatin for the initial (first-line) treatment of people with metastatic non-squamous non-small cell lung cancer (NSCLC) who do not have EGFR or ALK genomic tumour aberrations. The FDA is expected to make a decision on approval by 2 September 2019. “We look forward to working with the FDA in order to bring this Tecentriq-based combination to people with non-squamous non-small cell lung cancer as soon as possible,” said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. “Lung cancer is a challenging disease to treat, and this review takes us one step closer towards offering a new treatment option that has shown a clinically meaningful survival benefit in the treatment of this type of disease.” This sBLA is based on results from the Phase III IMpower130 study, which met its co-primary endpoints of overall survival (OS) and progression-free survival (PFS) in the initial treatment of people with metastatic non-squamous NSCLC.   ]]> <![CDATA[Glenmark receives tentative ANDA approval for generic Zytiga]]> https://biospectrumindia.com/news/95/12569/glenmark-receives-tentative-anda-approval-for-generic-zytiga.html https://biospectrumindia.com/news/95/12569/glenmark-receives-tentative-anda-approval-for-generic-zytiga.html Wed, 23 Jan 2019 10:35:00 +0530 Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted tentative approval by the United States Food & Drug Administration (U.S. FDA) for Abiraterone Acetate Tablets USP, 250 mg, a generic version of Zytiga®1 Tablets, 250 mg, of Janssen Biotech, Inc. According to IQVIATM sales data for the 12 month period ending November 2018, the Zytiga® Tablets, 250 mg market2 achieved annual sales of approximately $1.3 billion. Glenmark’s current portfolio consists of 148 products authorized for distribution in the U.S. marketplace and 54 ANDA’s pending approval with the U.S. FDA.  ]]> <![CDATA[Sun Pharma transfers domestic formulations distribution to subsidiary]]> https://biospectrumindia.com/news/95/12561/sun-pharma-transfers-domestic-formulations-distribution-to-subsidiary.html https://biospectrumindia.com/news/95/12561/sun-pharma-transfers-domestic-formulations-distribution-to-subsidiary.html Tue, 22 Jan 2019 13:25:00 +0530 Sun Pharma, India's top pharmaceutical company has announced some changes and clarifications. It has decided to transfer its domestic formulations distribution from Aditya Medisales Ltd to a wholly owned subsidiary. This change will be made effective by Q1FY20, post receipt of all requisite regulatory approvals. Sun Pharma also declared to settle down loans & advances given to Atlas Global Trading amounting to Rs.2,238 crore as the parties to the supply contract have now agreed in principle, that Atlas will assign its rights and obligations arising from contract, to wholly owned subsidiary of the company. In September 2014, Sun Pharma’s Halol facility (Gujarat) was impacted by US FDA cGMP issues which were finally resolved in June 2018, after nearly 4 years. These cGMP non compliances resulted in supply constraints thereby, Sun Pharma was not able to adhere to the agreed supply schedule with Atlas. Sun Pharma, in FY18, has funded Atlas towards non-fulfilment of its supply obligations till the time such obligations are fulfilled as per the agreement. The said funding was included in Loans & Advances schedule of Sun Pharma’s FY18 consolidated balance sheet. his transaction is expected to be concluded in FY19. Sun Pharma has initiated steps to induct S R B C & CO LLP, its statutory auditors, as auditors of subsidiaries that are currently audited by Valia & Timbadia. Sun Pharma hereby confirms affirmatively that neither any loans nor guarantees have been given to Suraksha Realty. Sun Pharma would like to dispel all falsehoods being spread about its financial dealings with Suraksha Realty. The company states unequivocally that it does not have any financial transactions with Suraksha Realty. ]]> <![CDATA[Zydus gets tentative USFDA approval for acid reflux capsules]]> https://biospectrumindia.com/news/95/12560/zydus-gets-tentative-usfda-approval-for-acid-reflux-capsules.html https://biospectrumindia.com/news/95/12560/zydus-gets-tentative-usfda-approval-for-acid-reflux-capsules.html Tue, 22 Jan 2019 12:00:00 +0530 Zydus Cadila is an innovative, global pharmaceutical company that discovers, develops, manufactures and markets a broad range of healthcare therapies. The company has received the tentative approval from the USFDA to market Esomeprazole Magnesium Delayed-Release Capsules (US RLD – NEXIUM). It will be manufactured at the group’s formulations manufacturing facility at SEZ, Ahmedabad. Esomeprazole belongs to the group of medicines termed as proton pump inhibitors. Esomeprazole reduces the amount of acid secreted by the stomach. The drug is used to treat the symptoms of gastroesophageal reflux disease, to reduce the risk of stomach ulcers in some people taking pain medicines, treat patients with stomach infection (Helicobacter pylori) along with certain antibiotics and long-term treatment of conditions where stomach makes too much acid. The group now has 247 approvals and has so far filed over 330 ANDAs since the commencement of the filing process in FY 2003-04. ]]> <![CDATA[GSK plans to appoint new Chairman]]> https://biospectrumindia.com/news/95/12555/gsk-plans-to-appoint-new-chairman.html https://biospectrumindia.com/news/95/12555/gsk-plans-to-appoint-new-chairman.html Tue, 22 Jan 2019 10:25:00 +0530 GlaxoSmithKline plc (GSK), a science-led global healthcare company, has announced that Sir Philip Hampton has informed the Board of his intention to step down as non-executive Chairman and the Board has started the process to find a successor. Sir Philip was appointed to the Board on 1st January 2015. He was appointed as Deputy Chairman from 1st April 2015 and as Chairman from 7th May 2015. Vindi Banga, GSK’s Senior Independent Director, said: “The Group has a clear strategy, is delivering improved operating performance and has a clear pathway forward, this is a good time to start the process to find Philip’s successor.” ]]> <![CDATA[Lupin receives FDA approval for Levothyroxine Sodium Tablets]]> https://biospectrumindia.com/news/95/12554/lupin-receives-fda-approval-for-levothyroxine-sodium-tablets.html https://biospectrumindia.com/news/95/12554/lupin-receives-fda-approval-for-levothyroxine-sodium-tablets.html Tue, 22 Jan 2019 09:55:00 +0530 Pharma major Lupin announced that it has received approval for its Levothyroxine Sodium Tablets USP, 25 mcg, 50 mcg, 75 mcg,  88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg, 200 mcg, and 300 mcg from the United States Food and Drug Administration (FDA) to market a generic version of AbbVie, Inc’s Synthroid Tablets, 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg, 200 mcg, and 300 mcg. Lupin’s Levothyroxine Sodium Tablets USP, 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg, 200 mcg, and 300 mcg is the generic version of AbbVie, Inc’s Synthroid Tablets, 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg, 200 mcg, and 300 mcg. It is indicated for: Hypothyroidism: As replacement therapy in primary (thyroidal), secondary (pituitary), and tertiary (hypothalamic) congenital or acquired hypothyroidism Pituitary Thyrotropin (Thyroid-Stimulating Hormone, TSH) Suppression: As an adjunct to surgery and radioiodine therapy in the management of thyrotropin-dependent well-differentiated thyroid cancer Levothyroxine Sodium Tablets, 25 mcg, 50 mcg, 75 mcg, 88 mcg, 100 mcg, 112 mcg, 125 mcg, 137 mcg, 150 mcg, 175 mcg, 200 mcg, and 300 mcg had annual sales of approximately USD 2519.6 million in the US (IQVIA MAT September 2018). ]]> <![CDATA[Lilly reports results of ANNOUNCE]]> https://biospectrumindia.com/news/95/12550/lilly-reports-results-of-announce.html https://biospectrumindia.com/news/95/12550/lilly-reports-results-of-announce.html Mon, 21 Jan 2019 16:15:00 +0530 Eli Lilly and Company has reported that the results of ANNOUNCE, the Phase 3 study of LARTRUVO (olaratumab), in combination with doxorubicin in patients with advanced or metastatic soft tissue sarcoma (STS), did not confirm the clinical benefit of LARTRUVO in combination with doxorubicin as compared to doxorubicin, a standard of care treatment. Specifically, the study did not meet the primary endpoints of overall survival (OS) in the full study population or in the leiomyosarcoma (LMS) sub-population; there was no difference in survival between the study arms for either population. LARTRUVO was well tolerated; there were no new safety signals identified and the safety profile was comparable between treatment arms. LARTRUVO in combination with doxorubicin previously showed an OS benefit in STS in a 133-patient, U.S.-only, randomized Phase 2 trial, which led to accelerated approval by the U.S. Food and Drug Administrationand conditional marketing authorization by the European Medicines Agency. Continued approval is contingent upon verification of clinical benefit in a confirmatory trial. As ANNOUNCE did not confirm clinical benefit, Lilly is working with global regulators to determine the appropriate next steps for LARTRUVO. While these discussions are ongoing, patients who are currently receiving LARTRUVO may, in consultation with their physician, continue their course of therapy if they are receiving clinical benefit. For patients who have not previously received LARTRUVO, the results of the Phase 3 trial do not support initiating treatment with LARTRUVO in patients with STS, outside of participation in a clinical trial. At this time, Lilly is suspending promotion of LARTRUVO. Anne White, president, Lilly Oncology said, "Lilly was surprised and disappointed that LARTRUVO did not improve survival for patients with advanced soft tissue sarcoma in this study. Lilly is committed to helping people who have soft tissue sarcoma and we will carefully study the detailed data in an effort to better understand the different results between the two trials. We are thankful for the patients and physicians who have participated in the ANNOUNCE study." LARTRUVO is also being studied in an ongoing global, randomized, double-blind, placebo-controlled Phase 2 trial in advanced STS in combination with gemcitabine and docetaxel. Lilly expects to incur a charge in the first quarter of 2019 related to LARTRUVO. The exact amount of the charge has not yet been determined, but is estimated to be in the range of $70 million to $90 million (pre-tax), or approximately $0.10 per share (after tax). In addition, the company expects this to have an impact of approximately $0.17 per share on Lilly's full-year 2019 earnings per share guidance. Lilly will provide a full update to its 2019 financial guidance, including the impact of the potential Loxo Oncology acquisition, when it announces Q4 2018 earnings. This announcement does not change Lilly's 2020 minimum financial goals. ]]> <![CDATA[AffordPlan remarks 300% growth in maternity patient base]]> https://biospectrumindia.com/news/95/12547/affordplan-remarks-300-growth-in-maternity-patient-base.html https://biospectrumindia.com/news/95/12547/affordplan-remarks-300-growth-in-maternity-patient-base.html Mon, 21 Jan 2019 13:10:00 +0530 AffordPlan, a first-of-its-kind financial technology platform that enables healthcare savings for individuals, registers an annual growth of 300 percent in maternity patient care. Set up in 2016, AffordPlan has expanded its presence in five key cities including Delhi,  Bangalore,  Mumbai,  Pune and Ahmedabad. Of the total cost incurred during a treatment in private hospitals, 90 percent costs is out-of-pocket expenses which includes ultrasound scans, X-rays, medicines, etc. The fintech platform has received an overwhelming response from the hospitals and patients because of the unique nature of the product and services as it brings down the overall cost (including out-of-pocket expenses) of treatments by as much as 15-20 percent.   AffordPlan has partnered with 800 hospitals and healthcare ancillaries like pharmacies, path labs, etc. across the country. It has successfully tied up with over 60 percent hospitals in the small and midsize category in New Delhi NCR, helping patients to plan, save, and pay for planned, non-emergency, medical procedures, such as maternity, dental, cataract surgery and more. It smoothens the cash flow for the patient by breaking up the lump sum amount into smaller manageable instalments. AffordPlan allows patients to save an amount they are comfortable with on a daily, weekly, or monthly basis and to make payments as per their convenience through a number of platforms including cash payment at the AffordPlan desk or the local pharmacy; bank transfer and online payment; or the payments can even be collected from the customer's doorstep.    ]]> <![CDATA[Wockhardt receives USFDA approval for Leukemia drug]]> https://biospectrumindia.com/news/95/12544/wockhardt-receives-usfda-approval-for-leukemia-drug.html https://biospectrumindia.com/news/95/12544/wockhardt-receives-usfda-approval-for-leukemia-drug.html Mon, 21 Jan 2019 11:40:00 +0530 Pharmaceutical and biotechnology major Wockhardt has received approval from the United States Food & Drug Administration (US FDA) for an ANDA for 100mg and 400mg tablets of Imatinib Mesylate, which is used to treat many kinds of cancers and tumors. Wockhardt’s Imatinib Mesylate tablets are a generic version of Gleevec®, marketed in USA and other countries by Novartis. Imatinib stops the cancer cells from growing and is indicated for treating cancers like Leukemia and some Gastro-Intestinal tumors. According to IMS MAT1118, the product has sales of $707 million in the US. “Wockhardt is building a portfolio of oncology products in the US and has several pending ANDA’s for oncology products” said Dr. Habil Khorakiwala, Wockhardt Founder Chairman and Group CEO. “Further, oncology and other specialty products have always been a priority area for our US business and this product will further boost this focus” he said. Wockhardt will be launching this product in the United States, in a short period of time. With its nationwide distribution network and its excellent relationship with all major trade, retail and institutional customers, Wockhardt is already a significant player in the US pharmaceutical market. The product is being manufactured at a contract manufacturing facility, based near Hyderabad, India. ]]> <![CDATA[LupinLife to launch Corcal Bone & Beauty at LFW]]> https://biospectrumindia.com/news/95/12541/lupinlife-to-launch-corcal-bone-beauty-at-lfw.html https://biospectrumindia.com/news/95/12541/lupinlife-to-launch-corcal-bone-beauty-at-lfw.html Mon, 21 Jan 2019 10:20:00 +0530 LupinLife’s Corcal Bone & Beauty announces a collaboration with Lakme Fashion Week to celebrate #beautifullystrong women across India at the upcoming Lakme Fashion Week Summer/Resort 2019 edition. Marking its launch in India, the Corcal Bone & Beauty show will bring strong and beautiful women to walk the ramp through an online audition for women across India. Anil V Kaushal, Head, LupinLife Consumer Healthcare said, “It’s often seen that Women’s health doesn’t receive the attention it deserves. With demanding and multifaceted roles, from homemakers to working women, women’s health usually takes a back seat. Corcal Bone & Beauty is true health and beauty partner of all women which helps them prioritize health – focusing on being healthy within to stay beautiful." "Everyone is beautiful the way they are but only good health from within can help stay that way. To create awareness about the link between inner health and beauty, we are delighted to partner with Lakme Fashion Week to showcase a very beautiful collection by designer Rina Singh of Eka as well as have women tell their stories of inner strength and beauty", he added. Calcium deficiency is quite prevalent amongst the Indian women and more over with age there is a gradual erosion of good health affecting appearance of hair, skin and nails. All this gets pronounced particularly post pregnancy up to and beyond menopause. Corcal Bone & Beauty is a calcium supplement for women that helps strengthen bones along with healthy hair, skin, nails and teeth. It is available in a pack size of 10 easy-to-consume mini-tabs, at all leading pharmacy stores and e-commerce sites.   ]]> <![CDATA[Sesderma to launch Dr. Serrano Clinics in India]]> https://biospectrumindia.com/news/95/12534/sesderma-to-launch-dr-serrano-clinics-in-india.html https://biospectrumindia.com/news/95/12534/sesderma-to-launch-dr-serrano-clinics-in-india.html Fri, 18 Jan 2019 11:35:00 +0530 Sesderma India recently organised a press conference in New Delhi. The company which is a subsidiary of Sesderma Laboratories headquartered in Valencia, Spain announce its plan of launching Dr Serrano Clinics in India. Headed by Dr. Gabriel Serrano Sanmiguel, Founder and MD of Sesderma Laboratories, the press conference highlighted all the technological advancements and innovations that have been adopted by the company so far to deal with the rising dermo-cosmetic needs of people in India. Speaking on the same, Dr Gabriel Serrano Sanmiguel, Founder and MD of Sesderma Laboratories has mentioned, “Through the launch of Dr. Serrano Clinics across the length and breadth of Indian landscape, we aim to deliver the best aesthetic solutions, to the people who want to keep their skin looking youthful and beautiful for a longer time. At Dr. Serrano Clinics, they will be benefitted by our exclusive cosmeticprocedures based on Nanotechnology; customized to suit every skin need.” Sesderma was the first lab in Spain to use the nanotechnology in the formulation of their dermo-cosmetics and was also the first to launch a full line of products containing glycolic acid. As time progressed, the company expanded its reach worldwide and is now aiming to strengthen their foothold in Indian through their products and Aesthetic medicine formulations.     ]]> <![CDATA[Aurobindo Pharma’s subsidiary to acquire products from Spectrum Pharma]]> https://biospectrumindia.com/news/95/12532/aurobindo-pharmas-subsidiary-to-acquire-products-from-spectrum-pharma.html https://biospectrumindia.com/news/95/12532/aurobindo-pharmas-subsidiary-to-acquire-products-from-spectrum-pharma.html Fri, 18 Jan 2019 10:55:00 +0530 Aurobindo Pharma announces the signing of a definitive agreement to acquire a portfolio of seven branded oncology injectable products from Spectrum pharmaceuticals Inc. The acquisition also brings-in an experienced branded commercial infrastructure in the US. Acrotech Biopharma, a wholly-owned subsidiary of Aurobindo Pharma USA Inc., which in turn a wholly-owned subsidiary of Aurobindo Pharma Limited, will be acquiring the portfolio on a debt free and cash free basis. This acquisition is in line with our strategy to commercialize innovative proprietary medications. Commenting on the transaction, Dr. Ashish Anvekar, President of Acrotech, said: “We are excited to jump-start our mission of helping cancer patients across the globe by delivering clinically differentiated medications and leveraging strategic partnerships. We look forward to welcome an experienced team of employees from Spectrum who are essential to our mission.” Commenting on the transaction, Mr. N. Govindarajan, Managing Director of Aurobindo, said, “The acquisition announced today creates an ideal launch pad for Acrotech, and establishes our presence in the branded market, which is in line with our strategy to grow and diversify our business in the US.” Govindarajan added, “We look forward to deliver the benefits of this transaction to all our stakeholders including employees, patients, customers and healthcare providers across the US. “ The acquisition will help Aurobindo Group to enter the branded oncology market with a range of products which are well recognized by the oncology community. Aurobindo Group will also acquire a well-established and experienced branded commercial infrastructure to continue commercializing these brands.   ]]> <![CDATA[Zydus receives USFDA approval for glaucoma, altitude sickness drug]]> https://biospectrumindia.com/news/95/12531/zydus-receives-usfda-approval-for-glaucoma-altitude-sickness-drug.html https://biospectrumindia.com/news/95/12531/zydus-receives-usfda-approval-for-glaucoma-altitude-sickness-drug.html Fri, 18 Jan 2019 10:15:00 +0530 Zydus Cadila has received the final approval from the USFDA to market Acetazolamide ER Capsules (US RLD – Diamox). It will be manufactured at the group’s formulations manufacturing facility at Moraiya, Ahmedabad. Acetazolamide is a potent carbonic anhydrase inhibitor. Acetazolamide ER capsules are used to treat certain types of glaucoma (caused by increased ocular pressure) and to treat or prevent altitude sickness (acute mountain sickness). The group now has 246 approvals and has so far filed over 330 ANDAs since the commencement of the filing process in FY 2003-04. ]]> <![CDATA[Suven Life Sciences secures Product Patents in Australia and Singapore]]> https://biospectrumindia.com/news/95/12527/suven-life-sciences-secures-product-patents-in-australia-and-singapore.html https://biospectrumindia.com/news/95/12527/suven-life-sciences-secures-product-patents-in-australia-and-singapore.html Thu, 17 Jan 2019 15:05:00 +0530 Suven Life Sciences Ltd. has announced that the grant of one product patent from Australia and one product patent from Singapore corresponding to the New Chemical Entities for the treatment of disorders associated with Neurodegenerative diseases and patents are valid through 2036. The granted claims of the patents include the class of selective 5-HT4 and M1 PAM compounds respectively and are being developed as therapeutic agents for neurodegenerative disorders such as for the treatment of cognitive impairment associated with neurodegenerative disorders like Alzheimer’s disease, Attention deficient hyperactivity disorder (ADHD), Huntington’s disease, Parkinson and Schizophrenia etc. “We are very pleased by the grant of these patents to Suven for our pipeline of molecules in CNS arena that are being developed for cognitive disorders with high unmet medical need with huge market potential globally” says Venkat Jasti, CEO of Suven. Suven Life Science is a biopharmaceutical company focused on discovering, developing and commercializing novel pharmaceutical products, which are first in class or best in class CNS therapies using GPCR targets. Suven has 4 clinical stage compounds, a Phase 2 undergoing SUVN-502, Phase 2 ready SUVN-G3031, Phase 1 completed SUVN-D4010 and SUVN-911. In addition to these clinical compounds the Company has nine internally-discovered therapeutic drug candidates currently in various stages of pre-clinical development targeting conditions such as ADHD, dementia, depression, Huntington’s disease, Parkinson’s disease and pain. ]]> <![CDATA[Regulatory submission of Tafamidis by Pfizer accepted by USFDA]]> https://biospectrumindia.com/news/95/12517/regulatory-submission-of-tafamidis-by-pfizer-accepted-by-usfda.html https://biospectrumindia.com/news/95/12517/regulatory-submission-of-tafamidis-by-pfizer-accepted-by-usfda.html Thu, 17 Jan 2019 11:15:00 +0530 Pfizer has announced that the US Food and Drug Administration (FDA) accepted for filing the company’s New Drug Applications (NDAs) for tafamidis for the treatment of transthyretin amyloid cardiomyopathy (ATTR-CM). Pfizer has submitted two NDAs based on two forms of tafamidis: meglumine salt and free acid. Tafamidis is the only product to complete a Phase 3 trial evaluating its efficacy, safety, and tolerability in patients with ATTR-CM, a rare, fatal, and underdiagnosed condition. The tafamidis meglumine form (20 mg capsule) has been granted Priority Review. The FDA grants Priority Review to medicines that may offer significant advances in treatment or may provide a treatment where no adequate therapy exists. The tafamidis free acid form (61 mg capsule) will be under Standard Review. This form is bioequivalent to the 80 mg tafamidis meglumine dose, which was administered as four 20 mg capsules in the pivotal trial; it was developed for patient convenience to enable a single capsule for daily administration. The target PDUFA action date for a decision by the FDA is in November 2019. Brenda Cooperstone MD, Senior Vice President and Chief Development Officer, Rare Disease, Pfizer Global Product Development said, “The diagnosis of ATTR-CM is often delayed, primarily because disease awareness is low and patients often present with symptoms similar to more common causes of heart failure. In fact, we believe less than one percent of patients living with this disease are currently diagnosed. The FDA’s filing acceptance is an encouraging step toward our goal of further raising awareness and providing a treatment option for ATTR-CM patients who are in desperate need of an approved pharmacologic therapy. We look forward to working with the FDA to bring the first treatment for this deadly disease to patients.” The submission is based on findings from the pivotal Phase 3 Transthyretin Amyloid Cardiomyopathy (ATTR-ACT) study, which evaluated the efficacy, safety, and tolerability of tafamidis meglumine compared to placebo for the treatment of patients with ATTR-CM. ATTR-CM is a rare and progressive disease caused by destabilization of a transport protein called transthyretin, which is composed of four identical subunits (a tetramer). In ATTR-CM, heart failure occurs when unstable tetramers dissociate, resulting in misfolded proteins that aggregate into amyloid fibrils and deposit predominantly in the heart. Tafamidis is an oral, investigational product being evaluated as a potential treatment for ATTR-CM. Tafamidis is a small molecule that selectively binds at specific sites on the transthyretin tetramer to prevent destabilization of the transthyretin transport protein and formation of amyloid that causes ATTR-CM. It is not approved for any use in the United States.     ]]> <![CDATA[Merck, Roche to renew global distribution agreement]]> https://biospectrumindia.com/news/95/12495/merck-roche-to-renew-global-distribution-agreement.html https://biospectrumindia.com/news/95/12495/merck-roche-to-renew-global-distribution-agreement.html Tue, 15 Jan 2019 12:40:00 +0530 Merck and Roche have agreed to renew their current distribution agreement for the Biochemical Reagents and Kapa Biosystems product portfolios, as well as select qPCR & Nucleic Acid Purification products.  Under the agreement, Merck will continue to employ its sales, marketing and e-commerce expertise, providing customers with continued access to high quality Roche products.  This agreement, initiated between the two life science industry leaders in 2015 and originally extending to 2020, will now continue for an additional five years, maintaining global exclusivity in most regions.The extension demonstrates the two organizations’ commitment to bringing high-quality products to customers and providing them with the research tools needed to solve the toughest problems in life science.  The global distribution agreement will extend through 2025 and is effective January 1, 2019.   ]]> <![CDATA[Zydus receives USFDA approval for skin, heart drugs]]> https://biospectrumindia.com/news/95/12487/zydus-receives-usfda-approval-for-skin-heart-drugs.html https://biospectrumindia.com/news/95/12487/zydus-receives-usfda-approval-for-skin-heart-drugs.html Mon, 14 Jan 2019 10:10:00 +0530 Zydus Cadila has received the final approval from the USFDA to market Betamethasone Dipropionate Cream USP (US RLD – DIPROLENE® AF), 0.05%. It will be manufactured at the group’s Topical manufacturing facility at Ahmedabad. This medication is a strong corticosteroid and is used to treat a variety of skin conditions (e.g., eczema, dermatitis, allergies, rash). Betamethasone reduces the swelling, itching and redness that can occur in these types of conditions. The group also received a final approval for Amlodipine and Atorvastatin Tablets USP (US RLD – Caduet) in the strengths of 2.5 mg/10 mg, 2.5 mg/20 mg, 2.5 mg/40 mg, 5 mg/10 mg, 5 mg/20 mg, 5 mg/40 mg, 5 mg/80 mg, 10 mg/10 mg, 10 mg/20 mg, 10 mg/40 mg, and 10 mg/80 mg. It will be manufactured at the group’s formulations manufacturing facility at SEZ, Ahmedabad. This combination product contains two active ingredients - amlodipine and atorvastatin. Amlodipine reduces blood pressure and the workload on the heart by relaxing the walls of the blood vessels. It is used to lower blood pressure and to treat angina (chest pain). Atorvastatin is used in combination with diet and exercise to treat high cholesterol. It works by blocking an enzyme that is needed to make cholesterol in the body. ]]> <![CDATA[Organisational change at AstraZeneca to drive innovation]]> https://biospectrumindia.com/news/95/12486/organisational-change-at-astrazeneca-to-drive-innovation.html https://biospectrumindia.com/news/95/12486/organisational-change-at-astrazeneca-to-drive-innovation.html Mon, 14 Jan 2019 09:00:00 +0530 AstraZeneca has recently announced organisational changes to support continued scientific innovation and commercial success in the main therapy areas as the Company enters a new phase in its strategic development. Included in the changes will be the arrival at AstraZeneca of the world-renowned oncology scientist, José Baselga, as well as the creation of: Therapy area-focused Research and Development units that are responsible for discovery through to late-stage development - one for BioPharmaceuticals (Cardiovascular, Renal & Metabolism (CVRM) and Respiratory) and one for Oncology - with dynamic resource allocation across the Company’s pipeline. Mirrored commercial units - one for BioPharmaceuticals and one for Oncology. The creation of the BioPharmaceuticals commercial unit aligns product strategy and commercial delivery across CVRM and Respiratory. The Research and Development units and the commercial units will each be represented on the Senior Executive Team of AstraZeneca and report to Chief Executive Officer (CEO), Pascal Soriot. The Research and Development unit for BioPharmaceuticals will be led by Mene Pangalos, who was previously responsible for the Company’s Innovative Medicines and Early Development Biotech Unit. The Research and Development unit for Oncology will be led by Dr. Baselga, a foremost Oncology leader with vast experience in the development of innovative cancer therapies. ]]> <![CDATA[Hetero launches Generic Lapatinib in India]]> https://biospectrumindia.com/news/95/12479/hetero-launches-generic-lapatinib-in-india.html https://biospectrumindia.com/news/95/12479/hetero-launches-generic-lapatinib-in-india.html Fri, 11 Jan 2019 16:05:00 +0530 Hetero, one of India’s leading generic pharmaceutical companies and world’s largest producer of anti-retroviral drugs, has announced the launch of generic version of Lapatinib (250 mg) tablets in India. The product is marketed and distributed under the brand name ‘HERTAB’ by Hetero Healthcare Ltd. It is made available in two SKUs, each consisting of 30 tablets and 150 tablets. HERTAB (Lapatinib) is an oral therapy indicated for the treatment of postmenopausal women with HER2-positive advanced breast cancer patients whose disease has progressed after taking Trastuzumab therapy. Lapatinib is used in combination with other medication Capecitabine or Letrozole, which together, inhibit the growth of cancer cells in patients. ]]> <![CDATA[Sun Pharma recalls anesthesia injection from US market]]> https://biospectrumindia.com/news/95/12467/sun-pharma-recalls-anesthesia-injection-from-us-market.html https://biospectrumindia.com/news/95/12467/sun-pharma-recalls-anesthesia-injection-from-us-market.html Thu, 10 Jan 2019 15:45:00 +0530 Sun Pharmaceutical Industries, Inc. (SPII), a wholly owned subsidiary of Sun Pharmaceutical Industries, Ltd. is voluntarily recalling three lots of Vecuronium Bromide for Injection, 10 mg (lyophilized powder), and one lot of Vecuronium Bromide for Injection, 20 mg (lyophilized powder) to the hospital level. The Vecuronium Bromide for Injection has been found to contain particulate matter identified as glass. Sun Pharma said in a letter to the USFDA. Vecuronium Bromide for Injection is used as an adjunct to general anesthesia, to facilitate endotracheal intubation and to provide skeletal muscle relaxation during surgery or mechanical ventilation and is packaged in a glass vial. This product was distributed nationwide to wholesale customers and medical facilities, the drug maker said. The administration of a glass particulate, if present in an intravenous drug, may result in local irritation or swelling in response to the foreign material. More serious potential outcomes would include blockage and clotting in blood vessels, which may be life-threatening. To date, the company has not received any reports of adverse events related to this recall. ]]> <![CDATA[analytica Anacon India, India Lab Expo gearing up for 2019]]> https://biospectrumindia.com/news/95/12464/analytica-anacon-india-india-lab-expo-gearing-up-for-2019.html https://biospectrumindia.com/news/95/12464/analytica-anacon-india-india-lab-expo-gearing-up-for-2019.html Thu, 10 Jan 2019 14:20:00 +0530 With more than 9,500 visitors, analytica Anacon India, India Lab Expo 2018 and PHARMA Pro&Pack Expo had smashed all the records. With 9,641 visitors and 261exhibitors, analytica Anacon India, India Lab Expo and PHARMA Pro&Pack Expo has chalked up the best-ever result in its decade-old history and surpassed all expectations. The number of visitors rose by 25% over the previous edition in Hyderabad. Jointly held with PHARMA Pro&Pack Expo for the second year, the synergies between the trade fairs has resulted to setting of new records. Visitors from pharmaceuticals, chemicals, food processing, research and development among other segments explored the latest innovations from the laboratory technology, analysis, biotechnology, diagnostics, pharma packaging and processing. Almost all top companies within and around Hyderabad attended in large numbers and delegation trips were arranged by Messe Muenchen India for several companies. “The most important innovation platform for the industry” In view of the new record figures, Bhupinder Singh, CEO of Messe Muenchen India, stated: “We are pleased with the positive results and with the positive feedback from our exhibitors on the quality of attendees. Large delegations from Hetero, Aurobindo, Karnataka Drugs and Pharmaceuticals Manufacturers Association, Indian Drugs Manufacturers Association among others attended. Huge participation at the networking forums has reinstated our position as the most important innovation platform for the industry.” “Preparing for the future of research and instrumentation” Gautam Rajan, President, Indian Analytical Instruments Association on Anacon India conference said: “We organized the conference to cover advancements in analytical solutions for life sciences. This is a very relevant topic today, because the future of research and instrumentation lies in this industry. There are many changes taking place and this conference addressed these changes and how the industry will cope with such changes.” “Good footfall – we look forward to come back next year” One of the exhibitor representing Siemens Limited, Ajay Bhosle, Chief Manager – Healthcare & Pharmaceuticals said: We participated for the first time at analytica Anacon India andIndia Lab Expo where the footfall has been good and as per our expectations. We look forward to taking part in the next edition of the trade fairs.” “Fifth time participation and many more to come” Keith Hulme, Director at Starna Scientific Limited said: “We have been participating at the show for the last four years. We connected with many customers who are interested in our range of products. We have been successful in developing our business these last four years and will continue to participate at the trade fairs to grow our business further.” ]]> <![CDATA[Glenmark enters commercialization agreement for novel nasal spray]]> https://biospectrumindia.com/news/95/12461/glenmark-enters-commercialization-agreement-for-novel-nasal-spray.html https://biospectrumindia.com/news/95/12461/glenmark-enters-commercialization-agreement-for-novel-nasal-spray.html Thu, 10 Jan 2019 10:00:00 +0530 Mumbai headquartered Glenmark Pharmaceuticals Ltd. has announced that its Suisse subsidiary, Glenmark Specialty S.A., has entered into an exclusive licensing agreement with Yuhan Corporation for commercializing its novel nasal spray Ryaltris in South Korea. The agreement with Yuhan is Glenmark’s second regional licensing deal for Ryaltris. In July 2018, Glenmark entered into an exclusive licensing agreement with Seqirus Pty. Ltd. to commercialize Ryaltris in Australia and New Zealand. Ryaltris [olopatadine hydrochloride (665 mcg) and mometasone furoate (25 mcg)], developed by Glenmark, is a novel, investigational, fixed-dose combination nasal spray of an anti-histamine and a steroid, indicated for treatment of symptoms associated with seasonal allergic rhinitis (SAR) in patients over 12 years of age. Under the terms of the agreement, Glenmark will be responsible for manufacturing and supply of the product, while Yuhan will be responsible for regulatory filing and commercialization of Ryaltrisin South Korea. Glenmark will receive an upfront payment, regulatory and commercial milestone payments as well as royalties from Yuhan. “This partnership with Yuhan is in line with our vision to make Ryaltris the first global brand of Glenmark by launching it in several key markets. We are happy to collaborate with Yuhan as it is a strong and reputed player in South Korea and is aligned with Glenmark’s objective to provide quality novel products to fulfill unmet needs of patients,” said Glenn Saldanha, Chairman and Managing Director of Glenmark Pharmaceuticals. In May 2018, Glenmark filed a New Drug Application (NDA) for Ryaltris with the US Food and Drug Administration (US FDA), which is currently under review with the regulator. Glenmark plans to commercialize Ryaltris in various markets globally. The company will continue to explore commercial partnerships for Ryaltris in markets where it doesn’t have direct presence. ]]> <![CDATA[SEG101 therapy by Novartis gets FDA approval]]> https://biospectrumindia.com/news/95/12453/seg101-therapy-by-novartis-gets-fda-approval.html https://biospectrumindia.com/news/95/12453/seg101-therapy-by-novartis-gets-fda-approval.html Wed, 09 Jan 2019 12:40:00 +0530 Novartis has announced that the US Food and Drug Administration has granted crizanlizumab (SEG101) Breakthrough Therapy designation for the prevention of vaso-occlusive crises (VOCs) in patients of all genotypes with sickle cell disease (SCD). Also known as sickle cell pain crises, VOCs are unpredictable and extremely painful events that can lead to serious acute and chronic complications2. VOCs happen when multiple blood cells stick to each other and to blood vessels, causing blockages. Treatments that make blood cells and blood vessels less sticky may help reduce the number of days patients experience VOCs. Samit Hirawat, Head, Novartis Oncology Global Drug Development said, "Painful sickle cell crises matter because they can disrupt patients' lives, and often require hospital visits and medical attention. We look forward to working closely with the FDA over the coming months toward making crizanlizumab, a therapy that has the potential to prevent sickle cell pain crises, available in the US as soon as possible." According to FDA guidelines, treatments that receive Breakthrough Therapy designation are those that treat a serious or life-threatening disease or condition and demonstrate a substantial improvement over existing therapies on one or more significant end points based on preliminary clinical evidence. The FDA granted Breakthrough Therapy designation for crizanlizumab based on positive results of the Phase II SUSTAIN trial, which compared the P-selectin inhibitor crizanlizumab with placebo in patients with sickle cell disease. SUSTAIN showed that crizanlizumab reduced the median annual rate of VOCs leading to health care visits by 45.3% compared to placebo (1.63 vs 2.98, P=0.010) in patients with or without hydroxyurea therapy. The study also demonstrated that crizanlizumab significantly increased the percentage of patients who did not experience any VOCs vs placebo (35.8% vs 16.9%, P=0.010) during treatment. Patients taking crizanlizumab (5 mg/kg) experienced a similar incidence of treatment-emergent adverse events (AEs) (86.4% vs 88.7%) and serious AEs (25.8% vs 27.4%) compared to placebo, and a low incidence of discontinuations (3%) due to adverse events. Adverse events that occurred in 10% or more of the patients in either active-treatment group (2.5 mg/kg; 5 mg/kg) and at a frequency that was at least twice as high as that in the placebo group included arthralgia, diarrhea, pruritus, vomiting, and chest pain. There were no apparent increases in infections with crizanlizumab treatment.   ]]> <![CDATA[Zydus receives final USFDA approval for antipsychotic drug]]> https://biospectrumindia.com/news/95/12448/zydus-receives-final-usfda-approval-for-antipsychotic-drug.html https://biospectrumindia.com/news/95/12448/zydus-receives-final-usfda-approval-for-antipsychotic-drug.html Wed, 09 Jan 2019 10:45:00 +0530 Zydus Cadila has received the final approval from the USFDA to market Aripiprazole Tablets USP (US RLD – Abilify) in the strengths of 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg. It will be manufactured at the group’s formulations manufacturing facility at Moraiya, Ahmedabad. Aripiprazole is an antipsychotic drug (atypical type). It is used to treat mental/mood disorders such as bipolar disorder, schizophrenia, Tourette's disorder, and irritability associated with autistic disorder. It is also used in combination with other medications to treat depression. It works by helping to restore the balance of certain natural chemicals in the brain (neurotransmitters). The group now has 243 approvals and has so far filed over 330 ANDAs since the commencement of the filing process in FY 2003-04. ]]> <![CDATA[Lupin's NaMuscla® gets EC nod to treat Myotonia ]]> https://biospectrumindia.com/news/95/12443/lupins-namuscla-gets-ec-nod-to-treat-myotonia-.html https://biospectrumindia.com/news/95/12443/lupins-namuscla-gets-ec-nod-to-treat-myotonia-.html Tue, 08 Jan 2019 15:40:00 +0530 Lupin is pleased to announce that the European Commission (EC) has approved NaMuscla® (mexiletine) for the symptomatic treatment of myotonia in adults with non-dystrophic myotonic (NDM) disorders. Non-dystrophic myotonic disorders are a group of rare, inherited neuromuscular disorders which cause the inability to relax muscles following voluntary contraction. NaMuscla® reduces myotonia symptoms in adult patients, resulting in a significant improvement in patient quality-of-life and other functional outcomes. Lupin has partnering discussions ongoing for commercialization of NaMuscla® in European territories outside Germany and the UK. The EC approval follows the positive opinion which was issued by the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), in October 2018 and will apply to all 28 countries of the European Union, Norway, Iceland and Liechtenstein. The approval makes NaMuscla®, which recently had its orphan drug designation ratified by the EMA’s Committee for Orphan Medicinal Products (COMP), the first treatment to be licensed throughout the EU for the symptomatic treatment of myotonia in adults with NDM disorders. Lupin is preparing for the launch of NaMuscla®, which will occur in the initial markets of Germany and the UK in Q1 2019. “We are delighted by the decision of the European Commission to approve NaMuscla®, making it the first treatment to be licensed across the EU for patients with non-dystrophic myotonia,” said Thierry Volle, President EMEA, Lupin.   The approval was based on a pivotal Phase III clinical study (MYOMEX1) which enrolled 25 participants who were diagnosed with non-dystrophic myotonic disorders and symptomatic myotonia, in addition to bibliographical references, including a randomized, placebo-controlled clinical study and an observational study, to support the efficacy and safety of mexiletine. ]]> <![CDATA[Sanofi, Regeneron reform global Immuno-Oncology Partnership ]]> https://biospectrumindia.com/news/95/12440/sanofi-regeneron-reform-global-immuno-oncology-partnership-.html https://biospectrumindia.com/news/95/12440/sanofi-regeneron-reform-global-immuno-oncology-partnership-.html Tue, 08 Jan 2019 14:50:00 +0530 Sanofi and Regeneron Pharmaceuticals, Inc. have restructured their global Immuno-oncology Discovery and Development Agreement for new immunooncology cancer treatments. The 2015 Agreement was scheduled to end in approximately mid-2020, and this revision provides for ongoing collaborative development of two clinical stage bispecific antibody programs. This provides Sanofi increased flexibility to advance its early-stage immuno-oncology pipeline independently while Regeneron retains all rights to its other immuno-oncology discovery and development programs. Under the terms of the restructured Agreement: Sanofi will pay Regeneron $462 million representing the balance of payments due under the original Immuno-oncology Agreement, which covers the Sanofi share of the immuno-oncology discovery program costs for the last quarter of 2018 and up to $120 million in development costs for the two selected clinical-stage bispecific antibodies, plus the termination fee for the other programs under the original immuno-oncology agreement. Sanofi secures the right to opt-in to the BCMAxCD3 and MUC16xCD3 bispecific programs when proof of concept is achieved or when the allocated funding is expended. Regeneron will commit up to $70 million to further develop the BCMAxCD3 bispecific antibody for multiple myeloma and up to $50 million to further develop the MUC16xCD3 bispecific for mucin-16 expressing cancers. Post-opt-in, Sanofi will lead development and commercialization of the BCMAxCD3 bispecific and fund 100 percent of development costs, with Regeneron reimbursing up to 50 percent out of its share of collaboration profits. Sanofi and Regeneron will share global profits equally. Post-opt-in, Regeneron will lead MUC16xCD3 bispecific development and lead commercialization in the U.S. The companies will share development costs and global profits equally. Sanofi will lead commercialization outside the U.S. The companies’ ongoing collaboration for the development and commercialization of Libtayo® (cemiplimab-rwlc), a PD1 antibody, is unaffected by the amended Discovery and Development Agreement. Regeneron retains full rights to its other immuno-oncology programs. Under the Immuno-Oncology License and Collaboration Agreement, the companies have developed and received U.S. Food and Drug Administration approval of Libtayo for advanced cutaneous squamous cell carcinoma (CSCC). A regulatory application for Libtayo has also been submitted in the EU. An ongoing joint clinical program is investigating Libtayo in multiple other cancers, and includes potentially pivotal trials in lung, cervical and skin cancers. Libtayo’s safety and efficacy has not been fully evaluated by any regulatory authority for indications beyond advanced CSCC. ]]> <![CDATA[Holmusk gets residency of Johnson & Johnson Innovation ]]> https://biospectrumindia.com/news/95/12436/holmusk-gets-residency-of-johnson-johnson-innovation-.html https://biospectrumindia.com/news/95/12436/holmusk-gets-residency-of-johnson-johnson-innovation-.html Tue, 08 Jan 2019 13:05:00 +0530 Holmusk became a resident company of Johnson & Johnson Innovation, JLABS (JLABS @ NYC), a premier life science incubator program. With its residency, Holmusk is excited to interact with other resident companies and looks forward to expanding its US footprint and deepening its relationship with partners and stakeholders within the pharma/life science hub of the US east coast. Holmusk's team at JLABS @ NYC will focus on building the world's largest real-world evidence (RWE) platform for behavioral health. This platform will incorporate the latest evidence from clinical trials and real-world data, brining insights to the point of care. Additionally, the platform will serve as a stepping stone to drive innovation among pharma companies to serve patients with unmet needs and allow quicker access to new drugs. Holmusk is proud to be a part of JLABS @ NYC, which provides an ideal stage to interact with the life science ecosystem. "Being part of JLABS is like being part of a world class network of entrepreneurs and thought leaders - we are excited to join the conversation," said Holmusk's Founder and CEO Nawal Roy. JLABS is a global network of open innovation ecosystems, enabling and empowering innovators to create and accelerate the delivery of life-enhancing health and wellness solutions to patients around the world. As a leader in innovation, JLABS helps entrepreneurs in pharmaceutical, medical device, consumer, and health tech bring healthcare solutions to patients and consumers.   ]]> <![CDATA[NaMuscla from Lupin receives EC Approval ]]> https://biospectrumindia.com/news/95/12435/namuscla-from-lupin-receives-ec-approval-.html https://biospectrumindia.com/news/95/12435/namuscla-from-lupin-receives-ec-approval-.html Tue, 08 Jan 2019 12:55:00 +0530 Lupin has announced that the European Commission has approved NaMuscla® (mexiletine) for the symptomatic treatment of myotonia in adults with non-dystrophic myotonic (NDM) disorders. Non-dystrophic myotonic disorders are a group of rare, inherited neuromuscular disorders which cause the inability to relax muscles following voluntary contraction. NaMuscla® reduces myotonia symptoms in adult patients, resulting in a significant improvement in patient quality-of-life and other functional outcomes. Lupin has partnering discussions ongoing for commercialization of NaMuscla® in European territories outside Germany and the UK. The EC approval follows the positive opinion which was issued by the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), in October 2018 and will apply to all 28 countries of the European Union, Norway, Iceland and Liechtenstein. The approval makes NaMuscla®, which recently had its orphan drug designation ratified by the EMA’s Committee for Orphan Medicinal Products (COMP), the first treatment to be licensed throughout the EU for the symptomatic treatment of myotonia in adults with NDM disorders. Lupin is preparing for the launch of NaMuscla®, which will occur in the initial markets of Germany and the UK in Q1 2019. Thierry Volle, President EMEA, Lupin said, “We are delighted by the decision of the European Commission to approve NaMuscla®, making it the first treatment to be licensed across the EU for patients with non-dystrophic myotonia. The EC approval represents a further important milestone for Lupin as we build a leading specialty pharma company focused on the development, registration and commercialization of science-based therapies and solutions for areas of unmet medical need.  We are now closer to being able to provide patients with an effective treatment for myotonia symptoms and we look forward to launching the product in the first territories in Q1 2019.” The approval was based on a pivotal Phase III clinical study (MYOMEX1) which enrolled 25 participants who were diagnosed with non-dystrophic myotonic disorders and symptomatic myotonia, in addition to bibliographical references, including a randomized, placebo-controlled clinical study and an observational study, to support the efficacy and safety of mexiletine. Professor Christiane Schneider-Gold of St. Josef und St. Elisabeth Hospital / Neurologische Universitätsklinik (Bochum, Germany) said, “The EC approval of NaMuscla® is very good news and an important step forward for NDM patients across the EU living with the burden of symptomatic myotonia.” “The approval and commercialization of NaMuscla brings to an end the difficult off-label treatment challenges faced by these patients. With no licensed antimyotonic drug being available to date, many patients have lived without treatment. NaMuscla® fills an important, unmet clinical need for a licensed, efficacious treatment with a positive risk-benefit profile which is proven to significantly improve patient quality-of-life and disability caused by myotonia’s lifelong impact”, he added. Today, more than 7500 people in Europe living with NDM have limited access to a licensed treatment for myotonia which reduces the daily burden of this disabling, lifelong symptom. Limited access leads to inconsistent medication supply, administrative challenges and associated financial burdens, which, along with low awareness and clinical experience among healthcare professionals, may result in harm to patients4. Lupin is also pursuing a paediatric investigation plan (PIP) for NaMuscla®.     ]]> <![CDATA[Vyome raises $22M to advance dermatology pipeline]]> https://biospectrumindia.com/news/95/12431/vyome-raises-22m-to-advance-dermatology-pipeline.html https://biospectrumindia.com/news/95/12431/vyome-raises-22m-to-advance-dermatology-pipeline.html Mon, 07 Jan 2019 16:20:00 +0530 Vyome Therapeutics Inc, a clinical-stage specialty pharmaceutical company developing novel medicines for treating skin diseases caused by resistant microbes has announced the closing of a $22 million financing. Vyome Therapeutics Inc. will primarily use the funds to advance its lead molecule, VB1953, through phase 2 studies for treatment of moderate to severe acne and for operations. Part of the funds raised are used for facilitating a secondary transaction. Venkateswarlu Nelabhotla, Chief Executive Officer of Vyome Therapeutics said, “The closing of Vyome’s Series D comes at a transformational time for the company, as we prepare to initiate a phase 2b clinical trial with our lead candidate, VB 1953, and as we establish the center of operations and headquarters in the United States through a corporate restructuring exercise. We see this investment as validation of Vyome’s innovative approach to efficient specialty pharmaceutical development and the ability of the company’s scientific platform to help solve the problem of microbial resistance in dermatology.” The financing was led by Iron Pillar, a venture growth investment fund with locations in Palo Alto and Mumbai. Existing investors, including Perceptive Advisors, Romulus Capital and Kalaari Capital also participated in this round. Mohanjit Jolly, Partner at Iron Pillar, added “We are thrilled to partner with Vyome and cement our long-standing relationship with the co-founders. This investment fits well with Iron Pillar’s approach of backing visionary entrepreneurs, together with patented platform technologies and products that have the potential to leapfrog the current market. Our advisors, who are dermatology experts in the U.S., are very encouraged by the early clinical efficacy and safety data from studies of VB 1953, and the depth and quality of science around the novel mechanism. We look forward to leveraging our cross-border network and U.S. capital markets experience to support Vyome as it seeks to establish itself as a leading specialty pharmaceuticals company.” Vyome’s lead molecule, VB 1953, is a topical bactericidal antibiotic candidate with a novel mechanism of action that includes inflammation reducing capabilities as well as the demonstrated ability to treat antibiotic resistant P. acnes strains and currently, a US phase 2b clinical trial is being initiated. In preclinical studies, VB 1953 is active against clindamycin resistant P. acnes bacteria, has a low emergence of resistance and reduces inflammation. VB 1953 is delivered with a microtechnology gel system that ensures the drug is retained at the site of infection and minimizes systemic exposure. ]]> <![CDATA[Lupin Pharma issues voluntary recall of Ceftriaxone for Injection ]]> https://biospectrumindia.com/news/95/12430/lupin-pharma-issues-voluntary-recall-of-ceftriaxone-for-injection-.html https://biospectrumindia.com/news/95/12430/lupin-pharma-issues-voluntary-recall-of-ceftriaxone-for-injection-.html Mon, 07 Jan 2019 16:05:00 +0530 Lupin Pharmaceuticals is voluntarily recalling 5 lots of Ceftriaxone for Injection, USP, 250mg, 10 lots of Ceftriaxone for Injection, USP, 500mg, 24 lots of Ceftriaxone for Injection, USP, 1g and 3 lots of Ceftriaxone for Injection, USP 2g, to the hospital/physician level. The products have been found to contain visual grey particulate matter in reconstituted vials. Improper piercing and use of a needle greater than 21 gauge (larger internal diameter), while reconstituting the vial, can push rubber flecks into the solution. There were no grey flecks seen prior to the reconstitution of the vials and the issue was identified upon standard visual inspection prior to patient administration. If injected, this product (containing rubber particulate matter from the stopper) could cause vein irritation/phlebitis or pulmonary embolic events that could result in permanent impairment of body function or damage to body structures, such as the lungs and vascular system. In addition, as ceftriaxone can be administered intramuscularly, the use of the product may result in local muscle inflammation and/or abscesses. Ceftriaxone for Injection, USP, is used as a sterile, semi-synthetic, broad-spectrum cephalosporin antibiotic for intravenous or intramuscular administration. It is used to reduce the development of drug-resistant bacteria and maintain the effectiveness of ceftriaxone sodium and other antibacterial drugs Ceftriaxone for Injection, USP, should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria. Ceftriaxone for Injection, USP, is packaged in a glass vial, in pack of 10, containing 10 vials in a carton, with NDC   ]]> <![CDATA[Lupin receives FDA approval for Lurasidone Hydrochloride Tablets]]> https://biospectrumindia.com/news/95/12429/lupin-receives-fda-approval-for-lurasidone-hydrochloride-tablets.html https://biospectrumindia.com/news/95/12429/lupin-receives-fda-approval-for-lurasidone-hydrochloride-tablets.html Mon, 07 Jan 2019 15:45:00 +0530 Pharma major Lupin has announced that it has received approval for its Lurasidone Hydrochloride Tablets, 20 mg, 40 mg, 60 mg, 80 mg & 120 mg from the United States Food and Drug Administration (FDA) to market a generic version of Sunovion Pharmaceuticals, Inc’s Latuda Tablets, 20 mg, 40 mg, 60 mg, 80 mg, and 120 mg. Lupin’s Lurasidone Hydrochloride Tablets, 20 mg, 40 mg, 60 mg, 80 mg & 120 mg is the generic version of Sunovion Pharmaceuticals, Inc’s Latuda Tablets, 20 mg, 40 mg, 60 mg, 80 mg, and 120 mg. It is indicated for treatment of adult patients with schizophrenia, monotherapy treatment of adult patients with major depressive episode associated with bipolar I disorder (bipolar depression), adjunctive treatment with lithium or valproate in adult patients with major depressive episode associated with bipolar I disorder (bipolar depression). Latuda Tablets, 20 mg, 40 mg, 60 mg, 80 mg, and 120 mg had annual sales of approximately USD 3217.3 million in the US (IQVIA MAT September 2018). For the financial year ended 31st March, 2018, Lupin’s Consolidated sales and Net profits before exceptional items were at Rs. 155,598 million (USD 2.41 billion) and Rs. 13,934 million (USD 216 million) respectively.     ]]> <![CDATA[every sixth person with respiratory disease lives in India: Cipla]]> https://biospectrumindia.com/news/95/12415/every-sixth-person-with-respiratory-disease-lives-in-india-cipla.html https://biospectrumindia.com/news/95/12415/every-sixth-person-with-respiratory-disease-lives-in-india-cipla.html Fri, 04 Jan 2019 15:25:00 +0530 Respiratory diseases are the second leading cause of death in the population aged 25 – 69 years in India. Worldwide, asthma is the second most common respiratory condition after COPD. It affects around 339 million people worldwide, 37.86 million of whom lives in India. The numbers mean that India ranks second globally in the Asthma prevalence ranking. Some may justify this ranking by the fact that India is the second most populous country. However, when we see the highest deaths and disability adjusted life years (DALYs) due to asthma, India tops the ranking. Dr Jaideep Gogtay, Global Chief Medical Officer of Cipla while speaking at HEAL Foundation’s 6th National Writers and Editors Convention highlighted that every sixth person with respiratory disease lives in India. He said, “Although India contributes to 15.69% in the prevalence of respiratory disease, the percentage rises to 30.28% for death and 32.07% for DALYs, which means every third respiratory disease patient who dies or contributes to DALYs is from India.” DALYs stands for Disability Adjusted Life Years and is now the main unit to measure the burden of a disease in a country. World Health Organization (WHO) defined 1 DALY as one lost year of healthy life. It is the gap between the current health status and the ideal health status of a person. “The state-wise disease burden is higher in states with weak infrastructure large population. Sadly, children make a large chunk of asthmatic patients with a horrifying figure of 18 million.  As asthma control remains dismal in India, 42% of patients have to visit the emergency department around 5 times a year and 18% of patients have to stay in hospitals for 2 to 3 times a year. The impact on ideal health can be understood by the fact that 93% of asthma patients reported absent from work or school”, Dr Gogate added.  The horrifying figures around asthma are a result of poor management. If the disease is managed properly, the patient can live a healthy life without any barriers. To highlight the importance of correct management Cipla has launched a campaign called #Berok Zindagi targeted to bust the myths around the management of asthma. The most effective treatment for asthma is inhalers, which are poorly accepted among masses. Many factors like lack of awareness, fear of social stigma, incorrect knowledge (last resort, habit-forming), a time constraint for educating and counselling patients, availability of alternative therapies have contributed to the rejection of inhalation therapy. However, it is important that people understand that inhalation therapy treats the disease with much lower doses than oral alternatives. Low doses mean low side-effects and better treatment means fewer absences from work and schools and fewer visits to emergency departments. With rising pollution, respiratory diseases can also be expected to rise. It is very important that people understand the disease and chose the correct treatment. Doctors also need to spend more time with their patients to be able to guide and counsel them. If India has to go down in the Asthma ranking, which we are not proud of, everyone has to come together to spread awareness and launch more programs like BerokZindagi.   ]]> <![CDATA[HealthCare atHOME receives GPW Certification]]> https://biospectrumindia.com/news/95/12413/healthcare-athome-receives-gpw-certification.html https://biospectrumindia.com/news/95/12413/healthcare-athome-receives-gpw-certification.html Fri, 04 Jan 2019 12:40:00 +0530 HealthCare atHOME (HCAH) has announced that it has been certified as a great workplace by the independent analysts at Great Place to Work®. HCAH earned this credential based on extensive ratings provided by its employees in anonymous surveys. HCAH is operational since 2012 and has grown from a 2-employee company to a company with more than 1500 resources. Maintaining the standards of employee satisfaction with such rapidly rising growth graph is not easy. Healthcare is a challenging job and the employees are always under the pressure to perform their best because one lapse can be a question of life or death for their clients. In such extreme working conditions, it is very important that employees are treated nicely and given due benefits. Happiness is contagious; a happy employee is a happy customer. People centric approach of the company has made it possible for HCAH to have a huge pool of happy customers and employees.  Any company is as great at its employee and HCAH has successfully made sure that their employees are upgraded with the latest technology and researches in the field of healthcare. Capacity building training, operational transparency and opportunities for talent have helped HCAH in securing a Trust Index Score of 82% in a survey conducted by GTPW®, which gauges credibility, respect, reasonableness, pride, and kinship. Vivek Srivastava, CEO & Co-founder HCAH says, “We are humbled to be recognized as one of the best places to work for in India. At HCAH, we practice an open-door policy where every employee has the freedom to express their views for the betterment of our operations. Work culture at HCAH revolves around four key values of trust, empathy, excellence, and care. Earlier the recognition was our happy patients and now receiving this certification confirms that the culture we have established is the right one, and we look forward to continuing and refining it further. The recognition was not possible without the support and dedication of HCAH family and I thank every single employee for playing their part in making HCAH a great place to work." "I hope, HCAH will maintain its rising growth graph and HCAH family members will keep raising the standard and quality bar in the years to come", he added. Great Place to Work® Certification Program is the first step for an organization in its journey to build a High-Trust, High-Performance Culture™ and HCAH has successfully achieved this milestone.   ]]> <![CDATA[India Pharma 2019 & India Medical Device 2019 to be held in Bengaluru ]]> https://biospectrumindia.com/news/95/12408/india-pharma-2019-india-medical-device-2019-to-be-held-in-bengaluru-.html https://biospectrumindia.com/news/95/12408/india-pharma-2019-india-medical-device-2019-to-be-held-in-bengaluru-.html Thu, 03 Jan 2019 16:25:00 +0530 The Department of Pharmaceuticals (DoP), Ministry of Chemicals and Fertilizers, along with Federation of Indian Chambers of Commerce & Industry (FICCI), is organising the 4th International Conference on Pharmaceutical & Medical Device sector on 18th – 19th February, 2019 in Bengaluru.  The theme for India Pharma 2019 is ‘Enabling Quality Affordable Healthcare’ and that of India Medical Device 2019 is ‘Med-Tech India: Gearing up for Ayushman Bharat’. V. Sadananda Gowda, Union Minister for Chemicals & Fertilizers and Statistics & Programme Implementation while addressing the media during the Curtain Raiser Press Conference for India Pharma 2019 & India Medical Device 2019 said, “Endevour of the Government is to provide affordable quality healthcare for all and boost indigenous pharma sector through ‘Make in India’. In this direction, Cabinet has given approval for 100 % FDI under automatic route for manufacturing of medical devices." He will inaugurate the two-day event, which is India’s biggest Global Conference on Pharma Industry and Medical Devices, and address the distinguished gathering in the presence of Mansukh L. Mandaviya, Minister of State for Chemicals & Fertilizers and Road Transport & Highways, Shipping. “The flagship event would bring key stakeholders of the pharma and medical devices sectors under one roof and provide an opportunity to discuss Government policy and challenges facing the Industry. Government is striving to make the processes in the sector as transparent and easy as possible.” Mansukh Mandaviya informed the gathering that, “the 4th edition of the event will have brainstorming sessions on  various aspects of Pharmaceuticals and Medical Device sector and in its 4th edition the event will help in resolving the bottlenecks of growth in the sectors.” Talking on the rationale of holding the annual conference, J.P. Prakash, Secretary (Pharmaceuticals) said that, “the event is held annually to get new and innovative ideas from all stakeholders in the conference. This helps the department to prepare the annual action plan for the Pharma and Medical Device Sectors. During the Conference, the annual action taken report on the issues raised at the last edition of the event, along with new areas of concern, will be discussed.” In the main event in Bengaluru, over 150 CEOs of the global pharma and medical device industry are expected to participate. International Drug Regulators from 15 countries have been invited to the event for interaction with Indian Drug Regulators and Industry Regulatory Officers. Ambassadors  & Commercial Counsellors of more than 50 countries have been invited for close interaction with Government of India and participating Industry. Thematic sessions will be held on areas of Artificial Intelligence in Pharma, Import Export issues, Biologicals, Biopharmaceuticals and New Chemical Entities (NCEs) for the Pharmaceutical Sector. For the Medical Devices Sector, thematic sessions will be held on Diagnostics Ecosystem, Ease of Doing Business and Health Technology Assessment (HTA) Framework. Technical workshop by World Health Organization will help in addressing key challenges before the industry and will also provide tremendous business linkages to the participating companies. The annual India Pharma & Medical Device Awards will be conferred by Department of Pharmaceuticals for various categories including India Pharma Leader Award, Innovation of Year Award, Bulk Drug Company of the Year Award and Medical Device Company of the Year Award. Other dignitaries present on the occasion today included Navdeep Rinwa, JS (Pharmaceuticals), Rajneesh Tingal;  Shubhra Singh, Chairperson, NPPA; Dr. S. Eswara Reddy, DCGI; and Dilip Chenoy, SG, FICCI. ]]> <![CDATA[Eris Life sciences join hands with Medtronic ]]> https://biospectrumindia.com/news/95/12407/eris-life-sciences-join-hands-with-medtronic-.html https://biospectrumindia.com/news/95/12407/eris-life-sciences-join-hands-with-medtronic-.html Thu, 03 Jan 2019 16:15:00 +0530 Pharma company Eris Lifesciences and medical technology company Medtronic Pvt. Ltd has announced their collaboration for a diabetes monitoring initiative in India. The two companies will utilize their respective strengths in helping patients monitor their diabetes better.  Medtronic will bring to India its latest US FDA approved Guardian™ Connect device for real-time evaluation of glucose variability in diabetes patients.  Eris through its national reach will provide the device at clinics and healthcare delivery units under its patient care initiative. Guardian Connect is the world’s first Smart Continuous Glucose Monitoring System connected with smartphone displays for real-time data viewing of glucose levels, without a separate hardware monitor.  Guardian Connect is a cutting edge device that stands out with built-in mechanisms for sending out alerts predicting high and low blood sugars 10-60 minutes in advance. These alerts pop up on the user’s smartphone (or Apple Watch) as notifications, just like regular text messages that pop up at regular intervals on mobile phones. The device also includes features like remote monitoring alerts via text messages and a web app that can be accessed from any internet-connected device. For example, in juvenile diabetes, a parent could view their child’s CGM data and receive alerts for low and high measurements in real-time. Commenting on the development, Amit Bakshi, Chairman and Managing Director, Eris Lifesciences said, “For better patient outcomes in diabetes, we believe that a holistic approach of medicine, diet and continuous monitoring is important. Technology has emerged as a great enabler in healthcare. While technology is transforming healthcare delivery, on the patient and physician end there is a need to create more awareness of how to use technology and how technology can make managing diabetes easier. Through this initiative, we aim to make patients and physicians adopt newer technologies for better health.” Describing the benefits of the collaboration, Madan Krishnan, Managing Director & Vice President, India Medtronic Pvt. Ltd., said, “Medtronic’s innovations in the space of Continuous Glucose Monitoring and Insulin Pumps has transformed diabetes management. Guardian Connect is a technological breakthrough that will change the diabetes treatment landscape. It empowers the patient to take control in real-time and the physician to be fully-equipped with data and evidence. In a large country like India, with high incidence of diabetes, we are happy to align with a partner who understands the challenges of diabetes management and has the reach to take our solutions across the country.” Although India has one of the highest incidence of diabetes, diagnosis and monitoring remain a challenge. Monitoring sugar levels is a critical element of managing diabetes. From the earlier blood glucose monitors (prick and test blood) to the new-age continuous monitoring device like Guardian Connect which has a small transmitter, mobile app and disposable sensor, monitoring glucose level has become very convenient and painless.   ]]> <![CDATA[4th edition of India Pharma & India Medical Device will shape pharma action plan for 2019]]> https://biospectrumindia.com/news/95/12406/4th-edition-of-india-pharma-india-medical-device-will-shape-pharma-action-plan-for-2019.html https://biospectrumindia.com/news/95/12406/4th-edition-of-india-pharma-india-medical-device-will-shape-pharma-action-plan-for-2019.html Thu, 03 Jan 2019 16:10:00 +0530 The Department of Pharmaceuticals will prepare its annual action plan which may re-visit the current policies based on inputs received from CEOs and international agencies, including the WHO, at the 4th edition of INDIA PHARMA 2019 and INDIA MEDICAL DEVICE 2019, to be held on 18-19 February 2019, in Bengaluru, Karnataka. This was stated by Mr D V Sadananda Gowda, Minister for Chemicals and Fertilizers, Government of India, while addressing the media at curtain raiser for the two-day event. INDIA PHARMA 2019 & INDIA MEDICAL DEVICE 2019 is a flagship annual event of Department of Pharmaceuticals, Ministry of Chemicals & Fertilizers and the Federation of Indian Chambers of Commerce and Industry (FICCI). The event will see the participation of some of the biggest names in the Indian pharmaceutical and medical devices industry who will come together on a common B2G platform to deliberate with the Government, drug regulatory agencies, pricing regulators and WHO on key policy changes required for the growth of the pharma and medical devices Industry. Drug regulators from US, European Union, United Kingdom, Mexico, Russia, Singapore, Indonesia, Vietnam, China, Uzbekistan, Argentina, Brazil, Ghana, Nigeria, Bangladesh and Sri Lanka are expected to take part in the event. Mr. Gowda said that affordability of medicines and medical devices and implants has been the subject of discussions between industry and government. He assured industry that the government will work with it to ensure the accessibility of medicines to all. He said that the government was striving to make processes in the sector as relevant and simple as possible. He cited the example of single window clearance in the pharma sector, which he described as a huge step as “We are dealing with medicines and the nature of the sector demands several checks and scrutiny at various levels. At present, our focus is on stabilising policies in terms of pricing and enabling a conducive environment for manufacturing in India”. Mr. Mansukh L. Mandaviya, Minister of State for Chemicals and Fertilizers, said that event will have brainstorming sessions on various aspects of pharmaceuticals and medical device sectors and hoped that the 2019 edition would help in resolving the issues impacting the growth of the sectors. ]]> <![CDATA[Diabetes major Eris Lifesciences joins hands with Medtronic for diabetes monitoring initiative]]> https://biospectrumindia.com/news/95/12404/diabetes-major-eris-lifesciences-joins-hands-with-medtronic-for-diabetes-monitoring-initiative.html https://biospectrumindia.com/news/95/12404/diabetes-major-eris-lifesciences-joins-hands-with-medtronic-for-diabetes-monitoring-initiative.html Thu, 03 Jan 2019 15:55:00 +0530 In a first of its kind collaborative initiative in India between a pharmaceutical and medical device company, Eris Lifesciences, one of the leading players in the chronic drugs segment and India Medtronic Pvt. Ltd, a wholly owned subsidiary of Medtronic plc, the global leader in medical technology has announced their collaboration for a diabetes monitoring initiative in India. The two companies will utilize their respective strengths in helping patients monitor their diabetes better. Medtronic will bring to India its latest US FDA approved Guardian Connect device for real-time evaluation of glucose variability in diabetes patients. Eris through its national reach will provide the device at clinics and healthcare delivery units under its patient care initiative. Guardian Connect is the world’s first Smart Continuous Glucose Monitoring System connected with smartphone displays for real-time data viewing of glucose levels, without a separate hardware monitor. Guardian Connect is a cutting edge device that stands out with built-in mechanisms for sending out alerts predicting high and low blood sugars 10-60 minutes in advance. These alerts pop up on the user’s smartphone (or Apple Watch) as notifications, just like regular text messages that pop up at regular intervals on mobile phones. The device also includes features like remote monitoring alerts via text messages and a web app that can be accessed from any internet-connected device. For example, in juvenile diabetes, a parent could view their child’s CGM data and receive alerts for low and high measurements in real-time. Although India has one of the highest incidence of diabetes, diagnosis and monitoring remain a challenge. Monitoring sugar levels is a critical element of managing diabetes. From the earlier blood glucose monitors (prick and test blood) to the new-age continuous monitoring device like Guardian Connect which has a small transmitter, mobile app and disposable sensor, monitoring glucose level has become very convenient and painless. Commenting on the development, Amit Bakshi, Chairman and Managing Director, Eris Lifesciences said, “For better patient outcomes in diabetes, we believe that a holistic approach of medicine, diet and continuous monitoring is important. Technology has emerged as a great enabler in healthcare. While technology is transforming healthcare delivery, on the patient and physician end there is a need to create more awareness of how to use technology and how technology can make managing diabetes easier. Through this initiative, we aim to make patients and physicians adopt newer technologies for better health.” Describing the benefits of the collaboration, Madan Krishnan, Managing Director & Vice President, India Medtronic Pvt. Ltd., said, “Medtronic’s innovations in the space of Continuous Glucose Monitoring and Insulin Pumps has transformed diabetes management. Guardian Connect is a technological breakthrough that will change the diabetes treatment landscape. It empowers the patient to take control in real-time and the physician to be fully-equipped with data and evidence. In a large country like India, with high incidence of diabetes, we are happy to align with a partner who understands the challenges of diabetes management and has the reach to take our solutions across the country.” ]]> <![CDATA[Alembic Pharma gets USFDA nod for Parkinson's treatment drug]]> https://biospectrumindia.com/news/95/12402/alembic-pharma-gets-usfda-nod-for-parkinsons-treatment-drug.html https://biospectrumindia.com/news/95/12402/alembic-pharma-gets-usfda-nod-for-parkinsons-treatment-drug.html Thu, 03 Jan 2019 13:10:00 +0530 Drug firm Alembic Pharmaceuticals has said that it has received approval from the US health regulator for Pramipexole Dihydrochloride extended-release tablets used for the treatment of Parkinson's disease. The approval from the United States Food and Drug Administration is for the company's abbreviated new drug application (ANDA) for Pramipexole Dihydrochloride extended-release tablets, in the strengths of 0.375 mg, 0.75 mg, 1.5 mg, 2.25 mg, 3 mg, 3.75 mg, and 4.5 mg, Alembic Pharmaceuticals said in a filing to BSE. The approved product is a therapeutic equivalent to the reference listed drug product (RLD) Mirapex ER tablets, of Boehringer lngelheim Pharmaceuticals Inc. Quoting IQVIA data, Alembic Pharma said Pramipexole Dihydrochloride extended-release tablets have an estimated market size of USD 38.6 million for twelve months ending December 2017. The company currently has a total of 84 ANDA approvals (71 final approvals and 13 tentative approvals) from USFDA, it added. ]]> <![CDATA[Hetero's subsidiary Amarox acquires TARBIS FARMA ]]> https://biospectrumindia.com/news/95/12397/heteros-subsidiary-amarox-acquires-tarbis-farma-.html https://biospectrumindia.com/news/95/12397/heteros-subsidiary-amarox-acquires-tarbis-farma-.html Wed, 02 Jan 2019 14:45:00 +0530 Hetero, India’s leading generic pharmaceutical companies and the world’s largest producer of anti-retroviral drugs, announced that its European subsidiary Amarox Limited has acquired Tarbis Farma, S.L.U., a company operating in Spain from Grupo Ferrer Internacional, S.A. Tarbis Farma comes with a robust product portfolio and an extensive marketing network with well-experienced personnel in Retail business across Spain. The acquisition enables Hetero with a strong front-end marketing presence giving the required commercial infrastructure, product portfolio, manpower and a seamless entry into the Retail, Hospital and Tender business channels in Spain. Mr. A V Narasa Reddy, Executive Director of Hetero Labs Limited, stated that this acquisition fits very well with Hetero’s growth strategy in EU giving Amarox a platform to reach out to the customers in a robust way with the present portfolio and Hetero’s pipeline of products. The buyer and seller were advised by Crowe and Deloitte respectively. ]]> <![CDATA[Shilpa Medicare receives US FDA approval for Irinotecan injection]]> https://biospectrumindia.com/news/95/12393/shilpa-medicare-receives-us-fda-approval-for-irinotecan-injection.html https://biospectrumindia.com/news/95/12393/shilpa-medicare-receives-us-fda-approval-for-irinotecan-injection.html Wed, 02 Jan 2019 12:00:00 +0530 Shilpa Medicare has announced that it has received approval from the US health regulator for Irinotecan HCL injection, used for treatment of certain kind of cancers.  The company has received US Food and Drug Administration (USFDA) approval for its ANDA Irinotecan HCL injection USP in the strengths 40 mg/2mL and 100 mg/5mL (20mg/mL) single dose vials. Irinotecan injection is used in the treatment of patients with metastatic carcinoma of the colon or rectum. Shilpa Medicare has been on path of expansion ever since its inception in 1987. With a regulatory recognized manufacturing set up and excellent scientific expert team in place, Shilpa Medicare has since been on a steady growth path. C Currently it is one of the leaders in the Oncology market and offers a complete range of products in this segment spanning across APIs, formulations both in terms of R&D and manufacturing capabilities. Further to consolidation in field of oncology API and formulations it is striving to put in its efforts in the field of novel drug delivery systems and biotech products along with widening its focus to other therapy areas. ]]> <![CDATA[Nuvo Pharma completes acquisition of Aralez Pharma]]> https://biospectrumindia.com/news/95/12390/nuvo-pharma-completes-acquisition-of-aralez-pharma.html https://biospectrumindia.com/news/95/12390/nuvo-pharma-completes-acquisition-of-aralez-pharma.html Tue, 01 Jan 2019 17:40:00 +0530 Nuvo Pharmaceuticals Inc. a globally focused, Canadian healthcare company with a portfolio of commercial products today announced that it has closed the previously announced acquisition of a portfolio of more than 20 revenue-generating products from Aralez Pharmaceuticals Inc. (Aralez). Key Benefits of the Transaction: Immediately and significantly accretive to revenue and adjusted EBITDA Revenue diversification from product sales and royalty revenues Provides Canadian platform with national sales infrastructure and an ability to launch and commercialize additional products Significant cash flow from U.S. and international royalties of global Vimovo® sales Low-cost financing from Deerfield Management Company, L.P. (Deerfield) Existing commercial infrastructure remains in place to ensure a smooth transition Products Acquired From AralezNuvo has acquired Aralez's Canadian specialty-pharmaceutical business, which was formerly known as Tribute Pharmaceuticals Canada Inc.  This is a growing business that includes: Cambia®, BlextenTM, SuvexxTM (sold as Treximet®in the U.S.), as well as the Canadian distribution rights to Resultz®, and will create a platform for Nuvo to acquire and launch additional commercial products in Canada.  Nuvo has also acquired the worldwide rights and royalties from licensees for Vimovo, Yosprala® and global, ex-U.S. product rights to MT400 (to be sold as Suvexx in Canada once registered and approved) which is currently commercialized in the U.S. as Treximet.   Transaction and Financing TermsThe aggregate purchase price paid by Nuvo to Aralez at closing was US$110 million (less a US$4.4 million deposit previously paid and subject to certain working capital and indebtedness adjustments).  Nuvo satisfied the purchase price through funding provided by certain funds managed by Deerfield, a leading, global, healthcare-specialized investor.  The transaction was approved by the Courts supervising Aralez's restructuring proceeds in both Canada and the United States. The funding arrangements with Deerfield include a 6-year, 3.5% p.a. interest amortizing loan in the principal amount of US$60 million, an 18-month 12.5% p.a. bridge loan in the principal amount of US$6.0 million, the issuance by Nuvo to Deerfield of 6-year, 3.5% p.a. interest, senior secured convertible notes in the principal amount of US$52.5 million, initially convertible into 19,444,444 common shares of the Company at a conversion price of US$2.70 (the Notes) and approximately 25,555,556 million common share purchase warrants, each such warrant initially exercisable for one common share of the Company for a period of six years from the date of issuance at an exercise price of $3.53 per share (the Warrants). The issuance of common shares of the Company upon the conversion of the Notes and the exercise of the Warrants is subject to shareholder approval under the rules of the Toronto Stock Exchange (TSX).  The Company intends to seek such shareholder approval on a post-closing basis (either by way of written consent or at a meeting of shareholders).   ]]> <![CDATA[Lupin gets FDA approval for Clobazam oral suspension]]> https://biospectrumindia.com/news/95/12389/lupin-gets-fda-approval-for-clobazam-oral-suspension.html https://biospectrumindia.com/news/95/12389/lupin-gets-fda-approval-for-clobazam-oral-suspension.html Tue, 01 Jan 2019 16:40:00 +0530 Pharma major Lupin announced that it has received approval for its Clobazam Oral Suspension, 2.5 mg/mL from the United States Food and Drug Administration (FDA) to market a generic version of Lundbeck Pharmaceuticals LLC’s Onfi Oral Suspension, 2.5 mg/mL. Lupin’s Clobazam Oral Suspension, 2.5 mg/mL is the generic version of Lundbeck Pharmaceuticals, LLC’s Onfi Oral Suspension, 2.5 mg/mL. It is indicated for adjunctive treatment of seizures associated with Lennox-Gastaut Syndrome (LGS) in patients 2 years of age or older. Clobazam Oral Suspension, 2.5 mg/mL had annual sales of approximately USD 260.2 million in the US (IQVIA MAT September 2018). ]]> <![CDATA[Ocular Therapeutix Announces Completion of Debt Refinancing]]> https://biospectrumindia.com/news/95/12388/ocular-therapeutix-announces-completion-of-debt-refinancing.html https://biospectrumindia.com/news/95/12388/ocular-therapeutix-announces-completion-of-debt-refinancing.html Tue, 01 Jan 2019 15:50:00 +0530 Ocular Therapeutix, a biopharmaceutical company focused on the formulation, development, and commercialization of innovative therapies for diseases and conditions of the eye, today announced that it has closed a refinancing of its existing debt by entering into a new $25.0 million term loan with MidCap Financial and Silicon Valley Bank. The 5-year term loan facility allows for an expansion of the Company’s prior $18 million credit facility to $25.0 million, all of which was drawn at closing. The proceeds from the loan were used to repay the approximately $12.3 million remaining balance under the prior facility and provide an additional $12.0 million of new funds, net of expenses and fees. The restated and amended agreement extends the term of the credit facility until December 21, 2023 and permits the Company to make interest-only payments until January 1, 2021. “We are pleased with the expansion and extension of our credit facility which not only strengthens our balance sheet with net new funds of $12.0 million but also improves near term cash flow through interest-only payments for the next 24 months, collectively extending the Company’s cash runway, based on current plans and forecasted expenses, into the third quarter of 2019,” said Donald Notman, Chief Financial Officer. ]]> <![CDATA[Zydus gets final USFDA approval for acne gel]]> https://biospectrumindia.com/news/95/12380/zydus-gets-final-usfda-approval-for-acne-gel.html https://biospectrumindia.com/news/95/12380/zydus-gets-final-usfda-approval-for-acne-gel.html Mon, 31 Dec 2018 15:05:00 +0530 Zydus Cadila has received the final approval from the USFDA to market Clindamycin Phosphate and Benzoyl Peroxide Gel, (US RLD – DUAC® Gel), 1.2%/5%. It will be manufactured at the group’s Topical manufacturing facility at Ahmedabad. This combination medication is used to treat a certain type of acne (inflammatory acne vulgaris). It helps to decrease the number of acne pimples. Clindamycin is an antibiotic that stops the growth of acne-causing bacteria. Benzoyl peroxide can also stop the growth of bacteria as well as reduce oil production in the skin. The group now has 242 approvals and has so far filed over 340 ANDAs since the commencement of the filing process in FY 2003-04. ]]> <![CDATA[NMPA approves Innovent's Tyvyt to market in china]]> https://biospectrumindia.com/news/95/12368/nmpa-approves-innovents-tyvyt-to-market-in-china.html https://biospectrumindia.com/news/95/12368/nmpa-approves-innovents-tyvyt-to-market-in-china.html Fri, 28 Dec 2018 15:45:00 +0530  Innovent Biologics, and Eli Lilly and Company ("Lilly") jointly announce today that the co-developed Tyvyt® (fully human anti-PD-1 therapeutic monoclonal antibody, generic name: sintilimab injection) has been granted approval for market authorization by the National Medical Products Administration of China ("NMPA", formerly the China Food and Drug Administration) for the treatment of patients with classical Hodgkin's lymphoma (cHL) that has relapsed or refractory (r/r) after two or more lines of systemic chemotherapy (r/r cHL). The approval of Tyvyt® (sintilimab injection) highlights the emergence of China in the field of Immuno-Oncology. Dr. Michael Yu, the Founder, Chief Executive Officer and Chairman of Innovent, said, "Tyvyt® (sintilimab injection) is an example of our success with the National Mega Innovation Program, and its approval highlights our achievements in immunotherapy and contributions to China's efforts to deliver innovative medicines. Innovent has shown its ability to develop large molecule drug and this approval is also a validation and the recognition of Innovent's R&D capabilities. I have confidence that Tyvyt® (sintilimab injection), with its global quality and cost-effectiveness, will bring better treatment to cancer patients in China." Dr. Wang Li, Senior Vice-President of Lilly China and Head of Lilly China Drug Development and Medical Affairs, said, "The efficacy and safety profile of Tyvyt® (sintilimab injection) is well proven in the ORIENT-1 trial. The drug provides a new immuno-oncology treatment option for patients with relapsed/refractory classical Hodgkin's lymphoma (r/r cHL). Lilly will continue to collaborate with outstanding local pharmaceutical companies to bring more innovative medicines to patients and help in demonstrating local R&D capabilities in global oncology community." Currently, Tyvyt® (sintilimab injection) is being studied in more than twenty clinical trials, including studies in first line non-squamous non-small cell lung cancer (NSCLC), first line squamous NSCLC, second line squamous NSCLC, EGFR mutant NSCLC after EGFR TKI treatment failure, first line gastric cancer, first line liver cancer, first line esophageal cancer, and second line esophageal cancer.   ]]> <![CDATA[SCHOTT KAISHA brings new portfolio of highly customizable prefillable glass syringes to India]]> https://biospectrumindia.com/news/95/12366/schott-kaisha-brings-new-portfolio-of-highly-customizable-prefillable-glass-syringes-to-india.html https://biospectrumindia.com/news/95/12366/schott-kaisha-brings-new-portfolio-of-highly-customizable-prefillable-glass-syringes-to-india.html Fri, 28 Dec 2018 12:30:00 +0530 Leading pharmaceutical packaging company, SCHOTT KAISHA has launched a highly specialized glass syringe portfolio in India, that further minimizes the risk of drug/container interactions for sensitive drugs. As part of its German partner SCHOTT’s iQ platform, syriQ BioPure is a hugely customizable glass prefillable staked-needle syringe (PFS) specifically designed to keep sensitive drugs stable over shelf life and shorten time to market while making administration more convenient for patients. Complex biotech drugs always face a threat of interacting with their container system. These interactions cannot be predicted and can lead to unintentional aggregation or deterioration of the drug which may eventually compromise the total cost of ownership, shelf life of the drug and treatment efficiency. Rishad Dadachanji, Director, SCHOTT KAISHA shares, “The syriQ BioPure syringes, manufactured in St. Gallen, Switzerland, combine features to ensure stability and safe administration of sensitive drugs. Our clients often work with complex biologicals that require an extremely reliable PFS solution. We are happy with the response that this offering is receiving from our existing and potential clients.” A Quality by Design approach, benchmark manufacturing and quality control processes using breakthrough inspection technology, combined with best-in-class components has established syriQ BioPure as a preferred container solution globally. Its application has proven to be beneficial in achieving: Ultra-low tungsten residuals (ICP-MS certificate available) Uniform silicon layer Low adhesive residuals Low E&L from latest high-quality elastomer formulations The new glass syringes work with leading safety and autoinjector devices, meeting market demand for products that can be administered at home for patient comfort. Seamless integration into these devices is reached thanks to the syringe’s high dimensional accuracy. About SCHOTT KAISHA: The company was established in 1991 as a premium manufacturer of pharmaceutical containers made of neutral glass in India under the name KAISHA Manufacturers Pvt. Ltd. In 2008, it started cooperation with the international technology group SCHOTT. The Indo-German joint venture is a leading supplier for the pharmaceutical industry offering a “one stop shop” solution for the entire range of small volume tubular glass parenteral packaging including ampoules, vials, cartridges and sterile prefillable glass syringes. About SCHOTT AG: SCHOTT is a leading international technology group in the areas of specialty glass and glass-ceramics. The company has more than 130 years of outstanding development, materials and technology expertise and offers a broad portfolio of high-quality products and intelligent solutions. SCHOTT is an innovative enabler for many industries, including the home appliance, pharma, electronics, optics, life sciences, automotive and aviation industries. SCHOTT strives to play an important part of everyone’s life and is committed to innovation and sustainable success. With more than 15,500 employees at production sites and sales offices in 33 countries, the group has a global presence. In the 2016/2017 fiscal year, SCHOTT generated sales of 2.05 billion euros. The parent company, SCHOTT AG, has its headquarters in Mainz (Germany) and is solely owned by the Carl Zeiss Foundation. As a foundation company, SCHOTT assumes special responsibility for its employees, society and the environment. ]]> <![CDATA[Suven Life Sciences secures Product Patents in Brazil and Eurasia ]]> https://biospectrumindia.com/news/95/12365/suven-life-sciences-secures-product-patents-in-brazil-and-eurasia-.html https://biospectrumindia.com/news/95/12365/suven-life-sciences-secures-product-patents-in-brazil-and-eurasia-.html Fri, 28 Dec 2018 11:45:00 +0530 Suven Life Sciences Ltd. has announced that the grant of  one (1) product patent from Brazil (PI 0312174-7) and one (1) product patent from  Eurasia (030947) corresponding to the New Chemical Entities for the treatment of disorders associated with Neurodegenerative diseases and patents are valid through 2023 and 2034 respectively. The granted claims of the patents include the class of selective 5-HT6 and 5-HT4 compounds respectively and are being developed as therapeutic agents for neurodegenerative disorders such  as for the treatment of cognitive impairment associated with neurodegenerative disorders like Alzheimer’s disease, Attention deficient hyperactivity disorder (ADHD), Huntington’s disease,  Parkinson and Schizophrenia etc. “We are very pleased by the grant of these patents to Suven for our pipeline of molecules in CNS arena that are being developed for cognitive disorders with high unmet medical need with huge market potential globally” says Venkat Jasti, CEO of Suven. Suven Life Science is a biopharmaceutical company focused on discovering, developing and commercializing novel pharmaceutical products, which are first in class or best in class CNS therapies using GPCR targets. Suven has 4 clinical stage compounds, a Phase 2 undergoing SUVN-502, Phase 2 ready SUVN-G3031, Phase 1 completed SUVN-D4010 and SUVN-911. In addition to these clinical compounds, the Company has nine internally-discovered therapeutic drug candidates currently in various stages of pre-clinical development targeting conditions such as ADHD, dementia, depression, Huntington’s disease, Parkinson’s disease and pain. ]]> <![CDATA[Dr. Reddy's laboratories announces the launch of Sevelamer Carbonate ]]> https://biospectrumindia.com/news/95/12364/dr-reddys-laboratories-announces-the-launch-of-sevelamer-carbonate-.html https://biospectrumindia.com/news/95/12364/dr-reddys-laboratories-announces-the-launch-of-sevelamer-carbonate-.html Fri, 28 Dec 2018 11:00:00 +0530 Dr. Reddy’s today announced the launch of Sevelamer Carbonate for Oral Suspension, in 0.8 g and 2.4 g packets. It is a therapeutic equivalent generic version of Renvela (sevelamer carbonate) for Oral Suspension, approved by the U.S. Food and Drug Administration (USFDA). The Renvela brand and generic had U.S. sales of approximately $101 million MAT for the most recent twelve months ending in October 2018 according to IMS Health. Dr. Reddy’s Sevelamer Carbonate for Oral Suspension is available in 0.8 g and 2.4 g packets in count size of 90. Renvela is a trademark of Sanofi ]]> <![CDATA[Sun Pharma arm gets relief from US court in trade secrets case]]> https://biospectrumindia.com/news/95/12360/sun-pharma-arm-gets-relief-from-us-court-in-trade-secrets-case.html https://biospectrumindia.com/news/95/12360/sun-pharma-arm-gets-relief-from-us-court-in-trade-secrets-case.html Thu, 27 Dec 2018 14:45:00 +0530 DUSA Pharmaceuticals, Inc., ("DUSA"), a wholly owned subsidiary of Sun Pharmaceutical Industries Ltd announced that DUSA has been granted preliminary injunctive relief by a federal district court prohibiting defendants Biofrontera Inc., Biofrontera Bioscience GmbH, Biofrontera Pharma GmbH, and Biofrontera AG (together known as "Biofrontera") from using DUSA's confidential and proprietary trade secret information. DUSA had filed a lawsuit against the Biofrontera defendants earlier this year in the US District Court for the District of Massachusetts. The lawsuit alleges trade secret misappropriation and patent infringement of DUSA's photodynamic therapy ("PDT") patents, US 9,723,991 and US 8,216,289, covering DUSA's product, LEVULAN® KERASTICK® (aminolevulinic acid HCl) for a topical solution, 20% used with DUSA's BLU-U Blue Light Photodynamic Therapy Illuminator.   DUSA, in its amended complaint filed in July 2018, had additionally alleged that the Biofrontera defendants misappropriated confidential and trade secret information from DUSA and improperly obtained confidential DUSA information from former DUSA employees to sell and market defendants' own products, including Ameluz (aminolevulinic acid hydrochloride) gel 10% and BF-RhodoLED. The lawsuit seeks an assessment of both damages and injunctive relief against the Biofrontera defendants. DUSA filed a motion for preliminary injunctive relief in November 2018 requesting an order prohibiting Biofrontera from using DUSA's confidential and proprietary trade secret information to sell and market its own products, including Ameluz and BF-RhodoLED. The court issued a preliminary injunction order, finding that "Biofrontera by its own admission is in possession of at least 600 DUSA documents obtained from 20+ employees that have left DUSA for Biofrontera in recent years," "that these documents contain confidential and proprietary information," and "that Biofrontera has competed against DUSA unfairly exploiting know-how that took DUSA years to develop." The court's order enjoins and prohibits Biofrontera from "making use of or disseminating DUSA's sales and financial information, customer lists and customer target lists, training and marketing materials, standard operating procedures, technical information, and unpublished clinical data, and any derivations thereof," effective immediately. The court also stated that "at this early stage, it would appear that DUSA has a reasonable prospect of success on the merits."   ]]> <![CDATA[Dr. Reddy's launches Sevelamer Carbonate for Oral Suspension ]]> https://biospectrumindia.com/news/95/12359/dr-reddys-launches-sevelamer-carbonate-for-oral-suspension-.html https://biospectrumindia.com/news/95/12359/dr-reddys-launches-sevelamer-carbonate-for-oral-suspension-.html Thu, 27 Dec 2018 13:05:00 +0530 Dr. Reddy’s Laboratories Ltd., along with its subsidiaries together referred to as “Dr. Reddy’s”) today announced the launch of Sevelamer Carbonate for Oral Suspension, in 0.8 g and 2.4 g packets, a therapeutic equivalent generic version of Renvela (sevelamer carbonate) for Oral Suspension, approved by the U.S. Food and Drug Administration (USFDA).    The Renvela brand and generic had U.S. sales of approximately $101 million MAT for the most recent twelve months ending in October 2018 according to IMS Health.  Dr. Reddy’s Sevelamer Carbonate for Oral Suspension is available in 0.8 g and 2.4 g packets in count size of 90.  Renvela is a trademark of Sanofi. ]]> <![CDATA[ICRA assigns stable outlook for Indian Pharma companies]]> https://biospectrumindia.com/news/95/12357/icra-assigns-stable-outlook-for-indian-pharma-companies.html https://biospectrumindia.com/news/95/12357/icra-assigns-stable-outlook-for-indian-pharma-companies.html Thu, 27 Dec 2018 13:00:00 +0530 ICRA has given a stable outlook on the Indian pharmaceutical industry. The headwinds from pricing pressure in large regulated markets, especially USA, increased cost related to regulatory compliances but are largely offset by growing scale of business, increased focus on specialty/ niche segments and comfortable balance sheet structure. The domestic pharmaceutical industry has gained adequate scale and generic drug development capabilities over a decade of growth which will keep them in good stead to capture bigger opportunities in the regulated market. The FY2018-2021 CAGR is expected to be around 8-10% for domestic Pharmaceutical companies. The credit metrics of leading pharma companies are likely to remain stable in view of steady growth prospects in regulated markets and limited dependence of Indian pharmaceutical companies on bank borrowings. The OPBITDA/Interest and TD/OPBITDA for ICRA set of 21 entities in Indian pharmaceutical industry has been healthy at 10.2x and 2.3x for FY2018. They are expected to remain in similar range in medium term despite some pressure on profitability and marginal rise in debt levels, given inorganic investments. The key sensitivity to our outlook remains productivity of R&D expenditure, increasing competition in the U.S. generics space and operational risk related to increased level of due diligence by regulatory agencies. The growth from US has come down sharply from 14.4% in FY2016, 4.0% in FY2017 to -13.1% in FY2018. Going forward the growth momentum would face continued headwinds given the relatively moderate proportion of large size drugs going off patent, increased competition, generic adoption reaching saturation levels in the US market along base effect catching up for Indian exporters. Further increased regulatory scrutiny as reflected in increased issuance of warning letters/import alerts and consolidation of supply chain in US market resulting in pricing pressures has impacted competitiveness of Indian pharmaceutical companies. The profitability for the industry, though expected to remain healthy, faces pressure from rising pricing pressures in US, increased regulatory compliance costs, rising R&D costs and other overheads and currency volatility related challenges in EMs. Overall, company specific factors would continue to play a pivotal role with quality of product pipeline (i.e. higher share of limited competition launches in the U.S.) being the single most differentiating factor. Companies with growing portfolio comprising of niche/complex products in regulated markets, diversified geographic-mix and established brands in EMs would be better placed to manage some of the headwinds.Over the past few years, pharma companies have increased their R&D budgets significantly in view of their growing focus on regulated markets and complex molecules/therapy segments. With R&D optimization efforts underway, we expect aggregate R&D spend to maintain at current levels despite requirements arising from expanding presence in complex therapy segment such as injectables, inhalers, dermatology, controlled-release substances and even biosimilars. ]]> <![CDATA[Dr. Reddy's launches Aspirin and Extended-Release Dipyridamole Capsules ]]> https://biospectrumindia.com/news/95/12354/dr-reddys-launches-aspirin-and-extended-release-dipyridamole-capsules-.html https://biospectrumindia.com/news/95/12354/dr-reddys-launches-aspirin-and-extended-release-dipyridamole-capsules-.html Thu, 27 Dec 2018 11:25:00 +0530 Dr. Reddy’s has announced the launch of Aspirin and Extended-Release Dipyridamole Capsules, a therapeutic equivalent generic version of Aggrenox (aspirin and extended-release dipyridamole) Capsules in the United States market from the U.S. Food and Drug Administration (USFDA). The Aggrenox brand and generic had U.S. sales of approximately $182 million MAT for the most recent twelve months ending in October 2018 according to IMS Health. Dr. Reddy’s Aspirin and Extended-Release Dipyridamole Capsules is available in 25 mg/200 mg strength with 60 count bottle size. Aggrenox is a trademark of Boehringer Ingelheim.   ]]> <![CDATA[Strand Life Sciences Organizes a Symposium in Noida ]]> https://biospectrumindia.com/news/95/12352/strand-life-sciences-organizes-a-symposium-in-noida-.html https://biospectrumindia.com/news/95/12352/strand-life-sciences-organizes-a-symposium-in-noida-.html Thu, 27 Dec 2018 10:25:00 +0530 According to the data by the Indian Council of Medical Research (ICMR), India is projected to have 17.3 lakh new cases of cancer by 2020 and over 8.8 lakh patients are expected to die from the disease. Breast cancer which has the highest incidence of all cancers in females has also become frequent in a population younger than 50 years. At times, breast/ovarian cancer occur due to inherited genetic mutations (this is called Hereditary Breast and Ovarian Cancer syndrome). A symposium was organized at Hotel Park Ascent in Noida by Strand Life Sciences to bring together domain experts from gynaecology and IVF to discuss this trend of higher incidence of breast and ovarian cancer and associated screening for early diagnosis. Dr. Ramesh Hariharan, CEO of Strand Life Sciences, was present at this occasion and shared Strand's capabilities as a diagnostic lab to screen such cancers. With the acquisition of Quest Diagnostics' India business, Strand is now better placed to cater to the North Indian market as well. He added, "We bring cutting-edge diagnostics to India with world class quality at affordable prices. This will help us all in our fight against cancer." Dr. Pooja Agrawal, from Strand Life Sciences, shared that the incidence of hereditary breast and ovarian cancer is much higher in India as compared to western countries and cited data from an original research paper from Strand along with cancer cases where Strand could help patients. Dr. Agrawal said, "It is not only important but also critical that early screening of cancer, which is cost-effective and comprehensive, should be adopted by the healthcare industry in India to reduce the high mortality rate in patients." The discussion was followed by a panel discussion on the topic 'Building synergy to screen early cancer in India'. The panel comprised of experts like Dr. Sushma Dikhit (Max hospital Vaishali), Dr. Anjana Singh (Fortis Hospital Noida), and Dr. Smita Jain (Neo IVF, Indirapuram). The symposium concluded with a final thought that we need more awareness and screening to help reduce the incidence of the breast and ovarian cancer.   ]]> <![CDATA[Aster CMI Hospital recognized for its excellence in Bariatric and Metabolic Surgery]]> https://biospectrumindia.com/news/95/12350/aster-cmi-hospital-recognized-for-its-excellence-in-bariatric-and-metabolic-surgery.html https://biospectrumindia.com/news/95/12350/aster-cmi-hospital-recognized-for-its-excellence-in-bariatric-and-metabolic-surgery.html Wed, 26 Dec 2018 17:55:00 +0530 In an acknowledgement of the advanced capabilities of Aster CMI hospital and its doctors and surgeons, the Obesity and Metabolic Surgery Society of India (OSSI) accredited the Bariatric and Metabolic Surgery unit of Aster CMI Hospital as a first Centre of Excellence (COE) in Karnataka and recognised Dr. H V Shivaram as its Programme Director. The Certification, conferred for a duration of three years, from December 2018 to December 2021, has recognised the unit for its excellent work and for following global standards in Laparoscopic, Bariatric and Metabolic surgeries. The department underwent a rigorous process of evaluation in the supervision of OSSI experts and was evaluated on various parameters such as facilities, capabilities and experience of the surgeons of the department, number of surgeries performed in stipulated timeline, infrastructure to manage special patients who are 200-300 kgs, specialized rooms, beds, cots and chair, and toilets as normal toilet would not be appropriate for patients who are heavy and so on. The unit was declared safe and as a Centre of Excellence for Bariatric and Metabolic surgery after meeting all the parameters. Commenting on the achievement Dr. Nitish Shetty, CEO, Aster CMI Hospital said “We would like to congratulate the entire department of Bariatric and Metabolic Surgery on being awarded the Centre Excellence for Bariatric and Metabolic surgery. We take immense pride in achieving this status. It gives us a sense of satisfaction and reassures the patients who undergo treatment at our hospital that they will be receiving quality care that meets best in class standards." "We would also like to thank Dr. Shivaram H.V. for helping us achieve this feat through his expertise and guidance. It is under his leadership, with a vast experience of conducting more than 400 such successful surgeries, our Bariatric and Metabolic surgery department has attained this distinction", he added. Dr. Shivaram H.V, Senior Consultant and Head of GI and Bariatric Surgery, Aster CMI Hospital on being awarded the programme director for Center of Excellence said “We have always endeavored to give the best of care and compassion to patients who visit our hospital. Achievements such as this highlight the efforts of our entire team and the prowess of the world class facilities at the hospital. While we have always believed that we are one of the best multi-specialty hospitals in the country, acknowledgement of our services from experts coming from outside the city encourages us to aim for higher goals.” The hospital has recently upgraded its bariatric unit with the launch of robotic bariatric surgery. In India presently, there are only about seven or eight hospitals which have been conferred the status of Centre of Excellence for their bariatric and metabolic surgery units.   ]]> <![CDATA[Lupin, AbbVie partner to develop novel oncology drug]]> https://biospectrumindia.com/news/95/12349/lupin-abbvie-partner-to-develop-novel-oncology-drug.html https://biospectrumindia.com/news/95/12349/lupin-abbvie-partner-to-develop-novel-oncology-drug.html Wed, 26 Dec 2018 11:25:00 +0530 Pharma major Lupin Limited and global biopharmaceutical company AbbVie Inc. has announced that AbbVie has licensed Lupin’s MALT1 (Mucosa-Associated Lymphoid Tissue Lymphoma Translocation Protein 1) inhibitor program. Through this partnership, AbbVie gains exclusive global rights to develop and commercialize Lupin’s MALT1 inhibitors. MALT-1 is a protein involved in T-cell and B-cell lymphocyte activation and AbbVie intends to pursue development across a range of hematological cancers, many with limited current treatment options. Commenting on the development, Nilesh Gupta, Managing Director, Lupin Limited said, “Delivering on new drugs was a key element of Dr. Deshbandhu Gupta’s vision. We are extremely proud of being able to realize his vision to bring new treatments to patients in need. We are very pleased to partner with AbbVie who share a commitment to deliver high quality medicines in areas that lack approved treatment and have a dire medical need. Their proven success in rapidly commercializing new targeted oncology treatments made them our partner of choice for this program.” Commenting on the partnership announcement, Dr. Raj Kamboj, President of Lupin’s Novel Drug Discovery and Development (NDDD) stated, “We are delighted with the success of our NDDD program to bring India’s first pharmaceutical innovation in this space. This is a first-in-class drug discovery program delivered exclusively by Lupin right from concept generation through the various stages of drug discovery and development. We are proud of the conceptualization, strategic direction and impeccable execution done by the team at Lupin that meets the global standard of pharmaceutical research.” Tom Hudson, M.D., Vice President, Discovery, AbbVie commented, “Lupin’s MALT1 program is exploring a new and innovative approach in difficult-to-treat cancers. AbbVie is committed to pursuing advanced treatment options for patients and we look forward to partnering our expertise in hematological oncology with Lupin’s discovery program to offer new hope to patients.” Under the terms of the agreement, AbbVie will pay Lupin an upfront payment of US$ 30 million for an exclusive license to the program. Upon successful completion of regulatory, development and commercial milestones, Lupin is eligible to receive total milestone payments of up to US$ 947 million. Additionally, Lupin will be entitled to receive a double-digit royalty on the sales of the product and will retain commercial rights to the program in India. Lupin’s Novel Drug Discovery and Development team is focused on building a pipeline of highly differentiated and innovative new chemical entities in the therapeutic areas of Oncology, Immunology and Metabolic disorders. Lupin’s NDDD activities were started in 2010 with the vision to use cutting-edge research in bringing novel molecules that address unmet medical needs in multiple therapeutic areas to market globally. ]]> <![CDATA[Transasia highlights the importance of Automation in Clinical Diagnostics]]> https://biospectrumindia.com/news/95/12348/transasia-highlights-the-importance-of-automation-in-clinical-diagnostics.html https://biospectrumindia.com/news/95/12348/transasia-highlights-the-importance-of-automation-in-clinical-diagnostics.html Wed, 26 Dec 2018 11:10:00 +0530 Transasia Bio-Medicals Ltd, India’s leading in-vitro Diagnostic Company recently organized a scientific seminar on the latest advancements in clinical diagnostics. Titled Transasia ScientificSeminar (TSS) Ace, this pioneering academic initiative aims at bringing together doctors in Tier II andTier III cities, thereby encouraging the exchange of technical know-how. This is the first time, that TSS Ace was conducted in Nanded, the city of Gurudwaras. The seminar highlighted biochemistry and hematology-the two most critical areas for in-vitro diagnostics. The session on ‘Journey from semi-automated to fully automated biochemistry analyzers’ by Dr. Milind Bhide, Managing Director-Bhide Laboratory, Mumbai; focused on the role of automation in increasing lab efficiency and decreasing manual intervention, leading to greater precision. This was followed by a discussion on ‘Shaping Hematology with 6 PDA automation’ led by Dr. Shanaz Khodaiji, Consultant – Dept.of Hematology and Transfusion Medicine, Hinduja Hospital, Mumbai. She emphasized on how the latest technologies assist in precise enumeration of the different parameters, thereby giving an in-depth analysis. Both the sessions were moderated by Chairperson, Dr Rajendra Mundra , a senior pathologist Practicing in Nanded past 40 years and also the head of Pahologist association of Nanded. The seminar received an overwhelming response with full house participation. In fact, the over 48 attendees also comprised pathologists and clinicians from nearby towns such as Latur, Aurangabad, Beed and Usmanabad. The attending doctors highly appreciated the efforts and demanded more such seminars to be held in the future as well. Speaking on the occasion Mr. Y.S. Prabhakar, CEO, Transasia Bio-Medicals Ltd. said, “There is an alarming burden on the society from both communicable and non communicable diseases in India. 70% of the treatment decisions are based on lab results. Yet, less than 30% of the Indian population has ever got their blood test done. The major chunk of the 70% population is in the smaller towns. At Transasia, we are committed to reaching out to the pathologists and clinicians in every nook and corner of the country, so that they are well equipped to cater to this population. TSS Ace is a unique platform that empowers the pathologists with the technological advances and encourages exchange of scientific updates, backed by expertise and experience. ” Over the years, TSS Ace has grown in popularity and has become Transasia’s identity. It has been well accepted as a successful forum and benefits more than 800 pathologists and clinicians annually. ]]> <![CDATA[Strides gets USFDA nod to market laxative drug in US]]> https://biospectrumindia.com/news/95/12346/strides-gets-usfda-nod-to-market-laxative-drug-in-us.html https://biospectrumindia.com/news/95/12346/strides-gets-usfda-nod-to-market-laxative-drug-in-us.html Wed, 26 Dec 2018 11:00:00 +0530 Drug firm Strides Pharma Science's subsidiary has received approval from the US health regulator to market laxative Polyethylene Glycol 3350 and Electrolytes for Oral Solution. Strides Pharma Global, Singapore, has received approval for Polyethylene Glycol 3350 and Electrolytes for Oral Solution USP in the strengths of 236 grams/2.97 grams/6.74 grams/5.86 grams/22.74 grams/4 Liter from the United States Food and Drug Administration (USFDA), Strides Pharma Science said in a filing to BSE. The approved product is a generic version of GoLYTELY of Braintree Laboratories. With the current approval, Strides now offers a complete range of PEG 3350 Laxatives for the US markets comprising of three approved products addressing a combined prescription and OTC opportunity of USD 400 million as per IMS and IRi data, the company said. The product will be manufactured at Strides' facility in Bengaluru and will be marketed by Strides Pharma in the US market. ]]> <![CDATA[Zydus Cadila gets USFDA nod for 2 drugs]]> https://biospectrumindia.com/news/95/12341/zydus-cadila-gets-usfda-nod-for-2-drugs.html https://biospectrumindia.com/news/95/12341/zydus-cadila-gets-usfda-nod-for-2-drugs.html Mon, 24 Dec 2018 14:35:00 +0530 Zydus Cadila has received final approval from the US health regulator to market Doxycycline Hyclate delayed-release tablets, used to treat bacterial infections.  Zydus Cadila has received the final approval from the United States Food and Drug Administration (USFDA) to market the drug in the strengths of 75 mg, 100 mg and 150 mg.  Zydus Cadila said the drug will be produced at the group’s formulations manufacturing facility at SEZ, Ahmedabad.  The group has also received tentative approval for Febuxostat tablets in the strengths of 40 mg and 80 mg, used to treat hyperuricemia (constantly high levels of uric acid) in adults who have gout.  The group has more than 241 approvals, and so far filed over 340 abbreviated new drug applications (ANDAs) since it started filings in 2003-04.   ]]> <![CDATA[Lupin announce partnership with AbbVie]]> https://biospectrumindia.com/news/95/12338/lupin-announce-partnership-with-abbvie.html https://biospectrumindia.com/news/95/12338/lupin-announce-partnership-with-abbvie.html Mon, 24 Dec 2018 13:15:00 +0530 Pharma major Lupin Limited (Lupin) and global biopharmaceutical company AbbVie Inc., has announced that AbbVie has licensed Lupin’s MALT1 (Mucosa-Associated Lymphoid Tissue Lymphoma Translocation Protein 1) inhibitor program.  Through this partnership, AbbVie gains exclusive global rights to develop and commercialize Lupin’s MALT1 inhibitors. MALT-1 is a protein involved in T-cell and B-cell lymphocyte activation and AbbVie intends to pursue development across a range of hematological cancers, many with limited current treatment options. Commenting on the development, Nilesh Gupta, Managing Director, Lupin Limited said, “Delivering on new drugs was a key element of Dr. Deshbandhu Gupta’s vision. We are extremely proud of being able to realize his vision to bring new treatments to patients in need. We are very pleased to partner with AbbVie who share a commitment to deliver high quality medicines in areas that lack approved treatment and have a dire medical need. Their proven success in rapidly commercializing new targeted oncology treatments made them our partner of choice for this program.” Commenting on the partnership announcement, Dr. Raj Kamboj, President of Lupin’s Novel Drug Discovery and Development (NDDD) stated, “We are delighted with the success of our NDDD program to bring India’s first pharmaceutical innovation in this space. This is a first-in-class drug discovery program delivered exclusively by Lupin right from concept generation through the various stages of drug discovery and development. We are proud of the conceptualization, strategic direction and impeccable execution done by the team at Lupin that meets the global standard of pharmaceutical research.” Tom Hudson, M.D., Vice President, Discovery, AbbVie commented, “Lupin’s MALT1 program is exploring a new and innovative approach in difficult-to-treat cancers. AbbVie is committed to pursuing advanced treatment options for patients and we look forward to partnering our expertise in hematological oncology with Lupin’s discovery program to offer new hope to patients.” Under the terms of the agreement, AbbVie will pay Lupin an upfront payment of US$ 30 million for an exclusive license to the program. Upon successful completion of regulatory, development and commercial milestones, Lupin is eligible to receive total milestone payments of up to US$ 947 million. Additionally, Lupin will be entitled to receive a double-digit royalty on the sales of the product and will retain commercial rights to the program in India.   ]]> <![CDATA[Holistic quality enhancement is the need of the hour: 70th Indian Pharmaceutical Congress ]]> https://biospectrumindia.com/news/95/12336/holistic-quality-enhancement-is-the-need-of-the-hour-70th-indian-pharmaceutical-congress-.html https://biospectrumindia.com/news/95/12336/holistic-quality-enhancement-is-the-need-of-the-hour-70th-indian-pharmaceutical-congress-.html Mon, 24 Dec 2018 12:05:00 +0530 With the aim of sharing best practices to aid the domestic industry become a world leader by 2030, the three-day 70thIndian Pharmaceutical Congress was organized at the Amity University Campus, NOIDA recently. It was inaugurated by Venkaiah Naidu, Vice President of India. More than 60 speakers from both India and abroad participated in the power-packed panel discussions on the critical topics like Over-The-Counter drug regulation, risk and safety in the era of multi-drug resistant microbial strains, the challenges people face in accessing quality diagnostic services, the relationship between the pharmacist – as the first point of contact – and the patient and how the menace of fake medicines can be curbed. Atul Nasa, Head of Office/ Controlling Authority, Drugs Control Department, Delhi, said on the occasion, “The coming months will see stricter implementation of quality standards and increased awareness of the risks of online pharmacy. OTC drugs need greater regulation to prevent unmonitored use and abuse”. BR Sikri, Chairman, LOC of 70th IPC said, “No other country in the world is able to supply affordable medicines to the world at affordable prices than India. The interaction between regulating authorities and top CEOs of industry will ensure that there is a more congenial interface between industry and the government to promote smoother access of life-saving medicines to all our people.” Whereas the Indian diagnostics market was a $ 9.6 million industry, just under 20% of Indians have ever given their blood for testing while Tier III & IV towns are deprived of quality diagnostic facilities. However, the government is fully geared to increase healthcare spending from 1.3% of the GDP to 2.5% of the GDP by 2025. Tele-pathology could play a great role in reducing costs of diagnostics in such cases. Increased penetration of health insurance can also play a pivotal role in increasing diagnostic access. Diagnosis was now moving from simple intervention to real-time monitoring and predictive markers. Hence, it offers vast employment opportunities to young and passionate learners. The Panel Discussion on Over-the-Counter drug retail and regulation, threw up crucial points such as the dangers of self-medication and the need to raise awareness of the rules concerning OTC medicine delivery and consumption. Dr. R Chandershekhar, Deputy Drugs Controller (I), CDSCO, stressed on the importance of compliance, safety and risk control standards in the age of e-pharmacy and online pharmacy. India exports pharmaceutical products to over 180 countries around the globe, of which, 30% goes to the US alone. While India’s drug industry is set to grow at 13%, the same sector in the US was growing at just 3%. For the first time, India exported drugs worth $ 17 billion – a huge achievement. In the next 10 years, India’s pharma trade will be worth $ 200 billion which speaks for the efficacy of India-made drugs in the world.   ]]> <![CDATA[Arvind and JCB India partner to provide safety-compliant industrial uniforms]]> https://biospectrumindia.com/news/95/12333/arvind-and-jcb-india-partner-to-provide-safety-compliant-industrial-uniforms.html https://biospectrumindia.com/news/95/12333/arvind-and-jcb-india-partner-to-provide-safety-compliant-industrial-uniforms.html Sat, 22 Dec 2018 09:00:00 +0530 Arvind Ltd. and JCB India Ltd. has announced a partnership to introduce protective, smart, comfortable, and stylish ready-to-wear Industrial Uniforms. This partnership is the first of its kind to offer co-branded protective wear and industrial uniforms for India’s workforce. The product range will be made available through Arvind & JCB India’s distribution network and point-of-sale locations across the country. Industrial uniforms have become essential in view of the increasing focus on occupational safety and health (OSH) and regulatory compliance in India. Stringent government norms, growing awareness about safety regulations, globalization of domestic companies, and the growing number of MNCs setting up manufacturing facilities in India have contributed to the increase in demand for safety-compliant and comfortable industrial uniforms. While the OSH market is growing, there is limited choice in branded ready-to-wear industrial uniforms in the country. The partnership between Arvind and JCB India will unlock new opportunities in this market segment by offering best-in-class products for core sectors like healthcare, pharmaceuticals, iron & steel manufacturing, mining, automobiles, defence, armed forces, and construction, among others. Arvind will complement JCB India’s safety shoes business with its value-added protective wear and personal protective equipment (PPE) product basket, which includes coveralls, dungarees, rain wear, and balaclavas. These products are fire-resistant, chemical-resistant, and shock-resistant, and possess other such properties that serve to protect factory workers, fire-fighters, construction crew, soldiers, healthcare professionals, and security personnel from the harsh operating environments that their respective jobs entail. Commenting on the partnership Mr. Ashish Kumar, CEO – Advanced Materials Division & Arvind Envisol, Arvind Limited said, “We are transforming our business quickly through technologies and partnerships that enable us to explore and create new opportunities. Extending textile manufacturing beyond fashion and into areas like safety and protection, is one of the areas we are focusing on. This partnership will leverage JCB’s market presence with Arvind’s textile manufacturing capabilities to provide industrial wear that will meet the highest standards of safety and protection.” “Safety is of paramount importance for us at JCB. It does not get limited to our machines on Construction sites only, but is an overarching philosophy. We are committed to introducing products which enhance safety and protection and our partnership with Arvind Limited gives us an exciting opportunity to do just that in the area of apparel. In India’s rapidly growing occupational safety and health market, we look forward to working together to create a market presence for value-added protective wear and personal protective equipment," said Mr. Vipin Sondhi, MD and CEO, JCB India Limited ]]> <![CDATA[Aurobindo Pharma to market Potassium Chloride ER Tablets ]]> https://biospectrumindia.com/news/95/12332/aurobindo-pharma-to-market-potassium-chloride-er-tablets-.html https://biospectrumindia.com/news/95/12332/aurobindo-pharma-to-market-potassium-chloride-er-tablets-.html Fri, 21 Dec 2018 17:20:00 +0530 Aurobindo Pharma Limited is pleased to announce that the company has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Potassium Chloride Extended Release tablets, 8 mEq (600 mg) and 10 mEq (750 mg). Potassium Chloride Extended-Release tablets, a generic version of Upsher-Smith’s Klor-Con® Extended Release tablets. The product will be launched in January 2019. Potassium Chloride tablets are indicated for the treatment of hypokalemia, with or without metabolic alkalosis, in digitalis intoxication, and in hypokalemic familial periodic paralysis. The approved product has an estimated market size of ~US$ 60 million for the twelve months ending October 2018, according to IQVIA. This is the 5 th ANDA (including 2 tentative approvals) to be approved out of Unit X formulation facility in Naidupet, India used for manufacturing oral products. Aurobindo now has a total of 396 ANDA approvals (368 Final approvals including 20 from Aurolife Pharma LLC and 28 tentative approvals) from USFDA. ]]> <![CDATA[Pharma World to discuss burning industry issues]]> https://biospectrumindia.com/news/95/12321/pharma-world-to-discuss-burning-industry-issues.html https://biospectrumindia.com/news/95/12321/pharma-world-to-discuss-burning-industry-issues.html Thu, 20 Dec 2018 17:25:00 +0530 While the Indian pharmaceutical industry registered sales of USD 36.7 Bn in 2017, the overall global market was USD 1.13 Trillion in 2017. Although it is expected to grow at a compound annual growth rate (CAGR) of 22.4 per cent to reach USD 55 billion by 2020, there still remains a major distance to travel before India can establish itself as an international pharma leader. With the theme Pharma Vision 2030 aimed at establishing India as the global industry leader, the 70th edition of the Indian Pharmaceutical Congress (IPC) is set to see one of the largest congregation of pharmacists and pharmaceutical  professionals discussing burning issues in the pharmaceutical industry, from December 21-23, 2018 at Amity University. Organized by the Indian Pharmaceutical Congress Association, a federation of five professional pharmaceutical bodies, and hosted by the Indian Pharmacy Graduates’ Association, IPC 2018 will see industry captains and thought leaders to discuss the challenges and solutions in the road to achieve Pharma Vision 2030. The 70th IPC will be inaugurated by the Vice-President of India, Shri Venkaiah Naidu, and presided by Dilip Shanghvi, President of 70th IPC and Managing Director of Sun Pharma. In a press conference,  Dr. Atul Nasa, Head of Office/Controlling Authority, Drugs Control Department, Delhi and Organising Secretary, LOC of 70th IPC, B R Sikri Managing Director, ABS Mercantile Pvt Ltd; Chairman – LOC, 70th IPC;  Dr Ashok K  Chauhan, Founder President RBEF, Chief Patron 70th IPC, and Mr. Pawan Kumar Jaggi, Former Drug Controller  addressed  the media about 70th IPC. The event is expected to attract 6,000 delegates this year from all the sections of the pharma fraternity. The event will also have 125 national and international speakers debating various high issues related to the India. A series of firsts amongst other highlights will rule the three-day mega pharma event. The Vice-President of India for the first time will meet 50 CEOs of top 50 companies in the Indian Pharma Industry. For the first time, a session has been kept on women empowerment and a Women Empowerment Committee  has been constituted. For the first time, rare disease and orphan drugs will discussed in IPC as well as in India, as the nation still stands unaware about unrecognized disease which are extremely hard to treat with known drugs. The latest developments of Make in India, Entrepreneurship, and Skill-Development will be discussed in the various sessions pertaining to the pharma industry. It is the largest ever congregation of minds from academia, regulatory, industry, student community will deliberate upon to gain more say in the world pharma space than what India enjoys today. Areas like ePharmacy, biosimilars, APIs and many other topics will be deliberated upon during the sessions. An open session has been kept where the regulator and industry will openly criticize each other, sharing various ideas without reservation. “The future looks bright and full of potential for the Indian pharma industry which is known globally for being a leading supplier of quality, affordable drugs to more than 200 countries. It has the highest number of USFDA approved plants, outside the USA. India accounts for the second largest number of Abbreviated New Drug Applications (ANDAs) and is global leader in Drug Master Files (DMFs) applications in the US. However, we have many challenges to counter on the road to achieve the vision of 2030. For the past 70 years, the meeting of minds at each edition of IPC has played a significant role in what we have achieved today. With endeavours to continue the momentum, the engaging discourses at IPC 70 will not only bring broad consensus across industry but also will help us map the way ahead”, said Dr. Atul Nasa, Head of Office/Controlling Authority, Drugs Control Department, Delhi and Organising Secretary, LOC of 70th IPC. With stimulating discourses planned over the three days, industry leaders and all stakeholders will deliberate upon important topics including APIs; generic formulations; diagnostics and medical devices; to biosimilar; pharmacovigilance; clinical research; herbal drugs and many more. Other key burning issues that would be discussed include the need for adequate regulatory framework to support investment on innovative products and expedite pre-clinical research launch of new drugs; need for time-bound implementation of policy interventions; boost clinical trial activity in India; shorten the approval processes and timelines; and reassess the available infrastructure for conducting clinical trial in India. IPC 70 will also act as a perfect platform to note the positive developments in the pharma and healthcare domains and will facilitate the drafting of a bigger strategy to maximize the positive developments. “There has been many positive and noteworthy developments in the past few years, as a result of the Government actively working to make healthcare more accessible everyone in India. While the launch of “Ayushman Bharat” is highly valued and will provide means for the Pharma Industry to serve the underserved, “Jan Aushadhi Kendra” is already reaping dividends. The “Make in India” initiative too has emboldened the ambition of Indian pharmaceuticals, with significant support from the government. Other initiatives like “Kaushal Bharat Kushal Bharat” for skill development and “Digital India” are pushing innovation and furthering the cause,” said Mr. Dilip Shanghvi, President of 70th IPC and Managing Director of Sun Pharma. Apart from industry debates on industry challenges and events, IPC 70 for the first time has a Women Empowerment Committee which will push for growth of women participation in the growth story of the industry. There is also a Health Awareness Walk for all age groups organized and awareness campaign to promote Swachch Bharat. As a boost to student fraternity who envision their career in the industry, for the first time, a Training and Placement Committee has been planned that will play an important role in giving leverage to the right talent. “One of the industry challenges is the lack of skilled workforce with the right knowledge. The curriculum and syllabus at Pharma Graduate and Post Graduate level should continuously be upgraded in line with newer regulations, guidelines, innovations and research, to keep it relevant and contemporary. A robust collaboration between industry and academia will enable innovation and growth in the education system and produce an employment-ready workforce,” said Mr. B. R. Sikri, Chairman Local Organizing Committee. The 70th IPC will also showcase a host of innovation in pharma technology and machineries as per the latest developments in the industry.   ]]> <![CDATA[Pfizer, GSK to create premier healthcare company]]> https://biospectrumindia.com/news/95/12319/pfizer-gsk-to-create-premier-healthcare-company.html https://biospectrumindia.com/news/95/12319/pfizer-gsk-to-create-premier-healthcare-company.html Thu, 20 Dec 2018 14:40:00 +0530 Pfizer Inc. and GlaxoSmithKline plc have entered into an agreement to create a premier global consumer healthcare company with robust iconic brands. The Boards of Directors of both companies have unanimously approved the transaction under which Pfizer will contribute its consumer healthcare business to GlaxoSmithKline’s existing consumer healthcare business. The 2017 global sales for the combined business were approximately $12.7 billion. Under the terms of the transaction, Pfizer will receive a 32% equity stake in the joint venture, entitling Pfizer to its pro rata share of the joint venture’s earnings and dividends, which will be paid on a quarterly basis. Pfizer will have the right to appoint three out of the nine members of the joint venture’s board. The transaction is expected to deliver $650 million in peak cost synergies and to be slightly accretive for Pfizer in each of the first three years after the close of the transaction, which is anticipated during the second half of 2019, subject to receipt of GSK shareholder approval and regulatory approvals, and satisfaction of other customary closing conditions. The joint venture will be a category leader in pain relief, respiratory, vitamin and mineral supplements, digestive health, skin health and therapeutic oral health and will be the largest global consumer healthcare business. In addition, the joint venture is expected to be the first or second largest consumer healthcare player in key geographies, including the United States, Europe, China, India and Australasia. The joint venture will operate globally under the GSK Consumer Healthcare name. ]]> <![CDATA[Ajinomoto and XL-protein unite to develop therapeutic compounds]]> https://biospectrumindia.com/news/95/12312/ajinomoto-and-xl-protein-unite-to-develop-therapeutic-compounds.html https://biospectrumindia.com/news/95/12312/ajinomoto-and-xl-protein-unite-to-develop-therapeutic-compounds.html Wed, 19 Dec 2018 15:35:00 +0530 Ajinomoto Bio-Pharma Services is a fully integrated contract development and manufacturing organization with sites in Belgium, United States, Japan and India.  Ajinomoto Bio-Pharma pleased to announce a Strategic alliance with XL-protein GmbH, a privately owned German biopharmaceutical company. Ajinomoto will apply its proprietary Corynex® expression system together with XL-protein's proprietary PASylation® technology for plasma half-life extension to develop a series of therapeutic compounds. Ajinomoto and XL-protein have established the efficient production of a PASylated proprietary GLP-1 variant with an extended half-life at laboratory scale yielding >3 grams soluble protein per liter bacterial culture including facile purification from the supernatant. The PASylated GLP-1 variant maintains high receptor affinity. In vivo pharmacokinetic studies in mice have revealed a drastically prolonged half-life, suggesting potentially weekly or biweekly dosing in human patients. Ajinomoto has started a partnering process for this molecule. Financial terms of the agreement have not been disclosed.   ]]> <![CDATA[Strides gets USFDA nod for Lidocaine Ointment ]]> https://biospectrumindia.com/news/95/12311/strides-gets-usfda-nod-for-lidocaine-ointment-.html https://biospectrumindia.com/news/95/12311/strides-gets-usfda-nod-for-lidocaine-ointment-.html Wed, 19 Dec 2018 13:20:00 +0530 Strides Pharma Science Limited (Strides) has announced that it step down wholly owned subsidiary, Strides Pharma Global Pte. Limited, Singapore, has received approval forLidocaine Ointment USP 5% from the United States Food & Drug Administration (US FDA). Lidocaine Ointment is a generic version of Xylocaine® Ointment of AstraZeneca Pharmaceuticals LP. Lidocaine Ointment contains a local anesthetic agent which is administered topically to numb and relieve pain from minor burns, skin abrasions, and other painful conditions affecting mucous membranes.  Lidocaine Ointment is also used to numb the skin before certain medical procedures. According to IQVIA MAT data, the US market for Lidocaine Ointment USP 5% is approximately $ 50million.  The product will be marketed by Strides Pharma Inc. in the US Market and will be launched immediately.   The company has 80  cumulative  ANDA filings with USFDA of which 54 ANDAs have been approved as of the date and 26 are pending approval. ]]> <![CDATA[The 12th edition of CPhI & P-MEC India Expo successfully organized at India Expo Centre]]> https://biospectrumindia.com/news/95/12307/the-12th-edition-of-cphi-p-mec-india-expo-successfully-organized-at-india-expo-centre.html https://biospectrumindia.com/news/95/12307/the-12th-edition-of-cphi-p-mec-india-expo-successfully-organized-at-india-expo-centre.html Wed, 19 Dec 2018 10:45:00 +0530 UBM India organized the 12th edition of South Asia’s largest Pharma event, the CPhI & PMEC India expo which was a three day show happened from December 12th–14th, 2018, at the India Expo Centre, Greater Noida, Delhi-NCR. The signature expo has been comprehensively assisted in its endeavors by governing bodies such as Pharmexcil, CIPI and IDMA. This year's edition witnessed participation from more than 1,600 exhibitors from 42 countries. Special pavilions by Pharmaceuticals Export Promotion Council of India (Pharmexcil), China Chamber of Commerce for Import & Export of Medicines & Health Products (CCCMHPIE) and China Council for the Promotion of International Trade (CCPIT) formed an intrinsic part of the expo. The expo was inaugurated by Guests of Honour, Satish W. Wagh, Chairman- CHEMEXCIL; Dr. Dinesh Dua, Chairman, Nectar Life Sciences Ltd; Ravi Uday Bhaskar, Director General, Pharmexcil; KV Rajendranath Reddy, IPS, Director General, Drugs Control Administration, Government of Andhra Pradesh; Mr Michael Duck, Executive Vice President, UBM Asia Ltd; Yogesh Mudras, Managing Director, UBM India, Adam Andersen, Group Brand Director Pharma, Informa and Rahul Deshpande, Group Director, UBM India, amidst an august industry gathering.  The 3rd edition of the India Pharma Week (IPW), the week-long pharma celebration packed with a melange of events was started on December 9, with the event, Pharma Leaders Golf, taking place in Mumbai as a tribute to the city where it was born. Speaking at the inauguration of the expo, Yogesh Mudras  said, “With the 12 edition of the CPhI & P-MEC India expo along with the India Pharma Week shifting to Delhi-NCR region, an important chapter in the pharma industry has unfolded today. According to our worldwide reputation pharma report, the CPhI Global Pharma Index, India has taken huge strides in terms of its reputation with a 10.92 per cent rise in reputation. This is the maximum increase globally and extremely impressive given the quality and compliance issues it had faced previously. It also ranks no 1 in terms of pharma market growth potential and is in the top 3 countries in terms of competitiveness. A lot of it is the result of government initiatives focusing on improving the health infrastructure especially in the rural markets, providing fiscal incentives, and streamlined development procedures, based on recommendation by industry thought leaders.”  “With the key stakeholders of the pharma industry congregated under the giant umbrella of the IPW here, these are some of the subjects -- along with the business -- that we will take to the next level at the power-packed sessions and engagements of this unrivalled celebration of the pharma industry,” he added. Key exhibitors at the CPhI & P-MEC India expo included Thermo Fisher Scientific, ACG, Excellence United, Aurobindo Pharma, Nectar Lifesciences, Hoong-A Corporation, Supriya Lifesciences, IMA, GEA Group, Optel Group, Bosch, Bowman & Archer, Solace Engineers, Morepen Laboratories, Hetero Labs, Neogen Chemicals, Akums Drugs & Pharmaceuticals, Granules India, Acebright Pharma, Zim Laboratories, Nitika Pharmaceuticals Specialities, Scope Ingredients, Evonik India, Colorcon Asia, Pioma Chemicals, IMCD India, Accupack Engineering, Pharmalab India, Ace Technologies, Gerresheimer, Uflex, Nipro Pharma Packaging, and Indo German Pharma Engineers, among many more. "CPhI and PMEC India offer a great platform to showcase products to our customers and network with existing and new clients. Given the number of suppliers that participate every year, CPHI-PMEC India has established itself as a premiere event in this segment. Customers not just from India but also from Middle-east, Africa and surrounding Asian countries attend the show to view products and explore new technologies and suppliers. We at Thermo Fisher have been consistently exhibiting at this event over the past nine years and have always received a great response. We presented our solutions through two separate booths, one each in CPhI and PMEC respectively. While the CPhI booth showcases our range of laboratory chemicals, consumables and lab equipment, the booth in PMEC offers customers glimpse into our industry leading cutting-edge analytical solutions in chromatography, mass spectrometry, molecular and elemental spectroscopy, informatics and data management. The 2018 show was a great success and offered an opportunity to interact with prospective clients. Customers were excited to see the workflow approach and appreciated our initiatives to provide holistic solutions that align with our mission to enable our customers to make the world healthier, cleaner and safer", pointed out Amit Chopra, Managing Director and VP/ GM India and Middle East, Thermo Fisher Scientific. Onsite, several innovative engagement platforms such as Supplier Finder, CPhI TV, Live Streaming, Mobile Apps, Tech Walls, Matchmaking - Live Pharma Connect, Exhibitor Showcase, and Innovation Gallery among others made the visitor experience an engaging and memorable one.   ]]> <![CDATA[Biocon Biosimilar Trastuzumab receives approvals in EU]]> https://biospectrumindia.com/news/95/12306/biocon-biosimilar-trastuzumab-receives-approvals-in-eu.html https://biospectrumindia.com/news/95/12306/biocon-biosimilar-trastuzumab-receives-approvals-in-eu.html Wed, 19 Dec 2018 10:35:00 +0530 Ogivri, a biosimilar Trastuzumab jointly developed by Biocon and Mylan, has been approved in the EU. The European Commission has granted Marketing Authorization for Ogivri to Biocon’s partner Mylan. The European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP} previously issued a positive opinion recommending approval of Ogivri as a biosimilar to Roche's Herceptin (Trastuzumab) on October 18,2018. Ogivri is indicated for the treatment of patients with HER2 positive early breast cancer (EBC), metastatic breast cancer (MBC) and metastatic gastric cancer (MGC). Under supervision of the relevant healthcare professional it can be prescribed as either monotherapy or in combination with other medicines dependent on the relevant diagnosis.    ]]> <![CDATA[Glenmark gets USFDA nod for contraceptive tablets]]> https://biospectrumindia.com/news/95/12288/glenmark-gets-usfda-nod-for-contraceptive-tablets.html https://biospectrumindia.com/news/95/12288/glenmark-gets-usfda-nod-for-contraceptive-tablets.html Tue, 18 Dec 2018 10:15:00 +0530 Glenmark Pharmaceuticals has received final approval from the US health regulator for generic version of Loestrin tablets used to prevent pregnancy."Glenmark Pharmaceuticals USA has been granted final approval by the US Food and Drug Administration (USFDA) for Hailey 24 Fe (Norethindrone Acetate and Ethinyl Estradiol tablets, USP and Ferrous Fumarate tablets), 1 mg/20 mcg, the generic version of Loestrin 1 24 Fe tablets, of Allergan Pharmaceuticals," the company said in a BSE filing today.According to IQVIATM sales data for the 12 months to September 2017, the Loestrin 24 Fe tablets market achieved annual sales of approximately USD 96.7 million, Glenmark said.The company's current portfolio consists of 128 products authorised for distribution at the US marketplace and 59 Abbreviated New Drug Applications (ANDA) pending approval with the USFDA. ]]> <![CDATA[Zydus receives USFDA approvals for Albendazole Tablets, Pregabalin Capsules]]> https://biospectrumindia.com/news/95/12287/zydus-receives-usfda-approvals-for-albendazole-tablets-pregabalin-capsules.html https://biospectrumindia.com/news/95/12287/zydus-receives-usfda-approvals-for-albendazole-tablets-pregabalin-capsules.html Tue, 18 Dec 2018 09:00:00 +0530 Zydus Cadila has received the final approval from the USFDA to market Albendazole Tablets USP (US RLD – ALBENZA tablets), 200 mg. It will be manufactured at the group’s formulations manufacturing facility at SEZ, Ahmedabad. This medication is used to treat certain tapeworm infections (such as neurocysticercosis and hydatid disease). The group also received a tentative approval for Pregabalin Capsules (US RLD – Lyrica) in the strengths of 25 mg, 50 mg, 75 mg, 100 mg, 150 mg, 200 mg, 225 mg and 300 mg. It will be manufactured at the group’s formulations manufacturing facility at Moraiya, Ahmedabad. Pregabalin is used to help control certain kinds of seizures, painful nerve diseases and fibromyalgia. ]]> <![CDATA[Lupin receives USFDA approval for Clobazam Tablets, 10 mg and 20 mg]]> https://biospectrumindia.com/news/95/12283/lupin-receives-usfda-approval-for-clobazam-tablets-10-mg-and-20-mg.html https://biospectrumindia.com/news/95/12283/lupin-receives-usfda-approval-for-clobazam-tablets-10-mg-and-20-mg.html Mon, 17 Dec 2018 15:35:00 +0530 Pharma company Lupin has announced that it has received approval for its Clobazam Tablets, 10 mg and 20 mg from the United States Food and Drug Administration (FDA) to market a generic version of Lundbeck Pharmaceuticals, LLC's Onfi Tablets, 10 mg and 20 mg. Lupin's Clobazam Tablets, 10 mg and 20 mg is the generic version of Lundbeck Pharmaceuticals, LLC's Onfi Tablets, 10 mg and 20 mg. It is indicated for the adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) in patients 2 years of age or older. Onfi Tablets, 10 mg and 20 mg had annual sales of approximately USD $601.2 million in the US (IQVIA MAT September 2018). ]]> <![CDATA[Biocon API facility in Telangana completes USFDA inspection]]> https://biospectrumindia.com/news/95/12284/biocon-api-facility-in-telangana-completes-usfda-inspection.html https://biospectrumindia.com/news/95/12284/biocon-api-facility-in-telangana-completes-usfda-inspection.html Mon, 17 Dec 2018 15:35:00 +0530 Biocon Ltd, Asia’s premier biopharmaceuticals company, has recently announced that the USFDA conducted a Good Manufacturing Practice (GMP) inspection of the APIs manufacturing facility at Telangana from Dec 12- Dec 14, 2018. The inspection concluded without any observations and no Form 483 was issued. According to the company, the successful inspection of this site reflects their strong commitment to quality and Current Good Manufacturing Practice (cGMP) compliance. ]]> <![CDATA[Lupin receives tentative USFDA approval for Tadalafil Tablets USP, 20 mg ]]> https://biospectrumindia.com/news/95/12282/lupin-receives-tentative-usfda-approval-for-tadalafil-tablets-usp-20-mg-.html https://biospectrumindia.com/news/95/12282/lupin-receives-tentative-usfda-approval-for-tadalafil-tablets-usp-20-mg-.html Mon, 17 Dec 2018 15:30:00 +0530 Pharma company Lupin has announced that it has received tentative approval for its Tadalafil Tablets USP, 20 mg from the United States Food and Drug Administration (FDA) to market a generic version of Eli Lilly and Company's (Lilly) Adcirca Tablets, 20 mg. Lupin's Tadalafil Tablets USP, 20 mg is the generic version of Lilly's Adcirca Tablets, 20 mg. It is indicated for the treatment of pulmonary arterial hypertension (PAH) (WHO Group 1) to improve exercise ability. Adcirca Tablets, 20 mg, had annual sales of approximately USD $ 503.8 million in the US (IQVIA MAT September 2018). ]]> <![CDATA[Glenmark gets ANDA approval for Hydrocortisone Valerate Ointment]]> https://biospectrumindia.com/news/95/12280/glenmark-gets-anda-approval-for-hydrocortisone-valerate-ointment.html https://biospectrumindia.com/news/95/12280/glenmark-gets-anda-approval-for-hydrocortisone-valerate-ointment.html Mon, 17 Dec 2018 15:20:00 +0530 Glenmark Pharmaceuticals Inc.,(Glenmark) has been granted final approval by the United States Food & Drug Administration (U.S. FDA) for Hydrocortisone Valerate Ointment USP, 0.2%, a generic version of Westcort® 1 Ointment, 0.2%, of Sun Pharmaceutical Industries, Inc. Glenmark has been granted a competitive generic therapy (CGT) designation for Hydrocortisone Valerate Ointment USP, 0.2%, therefore, with this approval, Glenmark is eligible for 180 days of CGT exclusivity upon commercialization. This is Glenmark’s first granted CGT product approved by the FDA. According to IQVIATM sales data for the 12 month period ending October 2018, the Westcort® Ointment, 0.2% market2 achieved annual sales of approximately $11.1 million*. Glenmark’s current portfolio consists of 145 products authorized for distribution in the U.S. marketplace and 55 ANDA’s pending approval with the U.S. FDA. In addition to these internal filings, Glenmark continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio. ]]> <![CDATA[Lupin receives tentative US FDA nod for multiple sclerosis drug]]> https://biospectrumindia.com/news/95/12272/lupin-receives-tentative-us-fda-nod-for-multiple-sclerosis-drug.html https://biospectrumindia.com/news/95/12272/lupin-receives-tentative-us-fda-nod-for-multiple-sclerosis-drug.html Fri, 14 Dec 2018 22:10:00 +0530 Pharma major Lupin has announced that it has received tentative approval for its Apixaban Tablets, 2.5 mg and 5 mg from the United States Food and Drug Administration (FDA) to market a generic version of Bristol-Myers Squibb Company's Eliquis® Tablets, 2.5 mg and 5 mg. Lupin's Dimethyl Fumarate Delayed Release Capsules, 120 mg and 240 mg is the generic version of Biogen, Inc's Tecfidera Capsules, 120 mg and 240 mg. It is indicated for the treatment of patients with relapsing forms of multiple sclerosis. Tecfidera Capsules, 120 mg and 240 mg had annual sales of approximately USD $3,545.4 million in the US (IQVIA MAT September 2018). ]]> <![CDATA[Medanta sets new benchmark of clinical excellence ]]> https://biospectrumindia.com/news/95/12267/medanta-sets-new-benchmark-of-clinical-excellence-.html https://biospectrumindia.com/news/95/12267/medanta-sets-new-benchmark-of-clinical-excellence-.html Fri, 14 Dec 2018 15:20:00 +0530 In continuation of its commitment to bringing world-class healthcare to all citizens, Medanta-The Medicity’s Cancer Institute met the exacting  international metrics of Postal Dosimetry Audit for CyberKnife and Tomotherapy. The audit is conjointly conducted by World Health Organisation and the International Atomic Energy Agency to optimize dose delivery in radiation therapy. IAEA has provided Postal Audit of Radiation Beam Dosimetry since 1969 to standardize treatment delivery. Medanta Cancer Institute offers the gold standard of internationally benchmarked radiation therapies to patients. Medanta Cancer Institute was among 15 centres worldwide to participate in the audit. It has successfully conducted 1,340 successful CyberKnife therapies and 780 Tomotherapy treatments till date. Dr. Naresh Trehan, Chairman and Managing Director, Medanta said, ‘’I congratulate the team for passing the world-renowned Postal Dosimetry Audit and becoming the first organisation in India to receive this certification. Exercises such as this re-enforce our credo of delivering excellent radiation therapy treatment for all our patients.” With the incidence of cancer cases rising exponentially, Radiation Oncology will play a crucial role in managing and curing cancer. Specialised treatment options such as CyberKnife and Tomotherapy that are non-invasive provide greater accuracy and minimise patient discomfort. Speaking on the achievement, Dr. Tejinder Kataria, Chairperson, Radiation Oncology, Medanta Cancer Institute said, ‘We are proud to have cleared this internationally benchmarked quality assurance audit and hope to deliver radiation therapies of global standards to patients. We look forward to serving both national and international patients who need superlative care through world-class treatment under a single roof.’’ ]]> <![CDATA[West showcases scientific insights, solutions for drug packaging, delivery]]> https://biospectrumindia.com/news/95/12268/west-showcases-scientific-insights-solutions-for-drug-packaging-delivery.html https://biospectrumindia.com/news/95/12268/west-showcases-scientific-insights-solutions-for-drug-packaging-delivery.html Fri, 14 Dec 2018 15:20:00 +0530 West Pharmaceutical Services, Inc., a global leader in innovative solutions for injectable drug administration, today announced the successful conclusion to a week of knowledge-sharing at CPhI India / P-MEC India.  Taking place in Delhi, the co-located CPhI India and P-MEC India tradeshows are the largest and most comprehensive pharmaceutical industry events in South Asia. During the meeting, West shared scientific insights and best practices in drug containment and delivery and showcased its Integrated Solutions Program.  “At West, our top priority is delivering quality products that meet the exact product specifications customers and regulators require and expect,” said Alagu Subramaniam, Managing Director, India, at West. “We have a well-established presence in India and work by the side of generics, biologics and pharmaceutical manufacturers in the Asia Pacific region and around the world, helping them respond to evolving market demand while meeting increasing quality standards. At CPhI India / P-MEC India we are proud to share our insights into bringing safe, effective drug products to patients quickly and efficiently.”  During the tradeshow, West highlighted its Integrated Solutions Program, which provides drug manufacturers with a comprehensive approach to injectable drug containment and delivery system development.  The program combines West’s suite of drug packaging and delivery products with its proven expert testing and support services to Simplify the Journey™ from molecule to patient by reducing development and supply risk, accelerating the path to market, minimizing total cost of ownership and improving the patient experience.  West also highlighted the following technologies during CPhI India / P-MEC India: AccelTRA™ component program—By offering market-leading delivery times and a single next-generation formulation for stoppers, the AccelTRA program can help generics manufacturers meet increasing quality standards, ensure fast response to market volatility and bring drug products to market quickly. SelfDose™ patient-controlled injector—An award-winning, off-the-shelf delivery system that is ergonomically designed for optimal patient administration. Extensive human factors studies have been performed with the SelfDose injector, confirming the intuitive design, supporting ease of use, patient safety and acceptance and potentially minimizing the need for validation, which can be costly and can affect speed to market. NovaGuard® SA Pro safety system—An innovative safety system that helps protect healthcare workers and patients from accidental needle stick injury. The NovaGuard SA Pro system can be deployed using a single-handed technique and was designed to prevent pre-activation during handling.  Additionally, West showcased insights from the Knowledge Centre in its booth at CPhI India / P-MEC India. The West Knowledge Centre provides scientific insight and detailed technical information on key areas of expertise, including technical reports, bulletins and science posters from West’s cross-functional team of scientists, engineers and technical experts, as well as respected industry organizations. It has quickly become a go-to destination for research and development professionals, scientists and other pharmaceutical professionals in India and across the globe seeking data and information on the science behind many of the industry’s top concerns regarding containment and delivery of injectable medicines. ]]> <![CDATA[Roquette announces its acquisition of major stake in Crest Cellulose]]> https://biospectrumindia.com/news/95/12260/roquette-announces-its-acquisition-of-major-stake-in-crest-cellulose.html https://biospectrumindia.com/news/95/12260/roquette-announces-its-acquisition-of-major-stake-in-crest-cellulose.html Thu, 13 Dec 2018 16:15:00 +0530 Roquette, a global leader in plant-based ingredients for Food, Nutrition and Health markets, announced the completion of the acquisition of a majority stake in Crest Cellulose, from Pravesha Industries, a major Pharma packaging company in India The creation of this joint-venture will reinforce Roquette’s position as a major supplier to the pharmaceutical industry and a global leader in superior natural-based pharmaceutical excipients. The addition of Crest Cellulose’s know-how and production capabilities to Roquette’s strong expertise and track-record in the pharmaceutical excipients market will create new opportunities for both Roquette’s and Crest Cellulose’s customers and employees as the companies both share a commitment towards innovation, quality and excellence. As a privately-owned company incorporated in 2012 and located in Hyderabad and in Nellore (India), Crest Cellulose takes pride in its robust infrastructure and technical platform. The company manufactures a wide range of superior excipients to address a strong and increasing demand in the pharmaceutical market. This strategic investment allows Roquette to expand its offering of pharmaceutical excipients and nutraceuticals, following the acquisition of Blanver Pharmaceutical’s excipients division in 2017. It also underpins Roquette’s commitment to increasing its footprint and proximity to customers in India to serve the large and fast-growing pharmaceutical sector. The size of this market was estimated at US$ 33 billion in 2017 and was growing at over 10% per year at the beginning of 2018. India supplies over half of the global demand for various vaccines, and 25% of all medicines in the world. As the majority shareholder, Roquette will have a controlling stake and manage the day-to-day operations of Crest Cellulose. ]]> <![CDATA[Indus Health Plus launches DNAwise, a personal genetic test]]> https://biospectrumindia.com/news/95/12246/indus-health-plus-launches-dnawise-a-personal-genetic-test.html https://biospectrumindia.com/news/95/12246/indus-health-plus-launches-dnawise-a-personal-genetic-test.html Wed, 12 Dec 2018 08:55:00 +0530 Indus Health Plus, the pioneer in the preventive healthcare sector, launched a revolutionary next-generation preventive healthcare service, DNAwise. DNAwise is a personal genetic test that decodes the genetic makeup and generates a report through which one can understand the health risks& personalize diet and fitness according to what suits them the best. Amol Naikawadi, Joint Managing Director, Indus Health Plus said, “The growing number of lifestyle diseases, irrespective of the age groups,stimulated us to create this unique platform of prevention. In an endeavor to create healthy future for individuals by expanding the umbrella of prevention, we have launched DNAwise. DNAwise analyses the health risks and food & fitness traits on the basis of one’s genetics. It can empower people to personalize their health checkups and make informed lifestyle choices. Knowing the genetic predispositions to various diseases helps an individual to delay/prevent the onset of diseases by modifying lifestyle.” “With the launch of DNAwise, we are advancing our mission to make healthcare accessible, available and affordable. At Indus, we believe that the culture of prevention and healthy wellbeing should start at an early age”added Naikawadi. DNAwise is a salvia based user-friendly genetic test which can be done from the comfort of home. The reporting and testing involvescutting edge technology and international standards. DNAwise is designed for all age groups and has 60 parameters related to Health, Nutrition and Fitness. The package is availablepan India, at INR14,999+GST and includessaliva sample kit, report andcounseling by a qualified genetic counselor. A successful pilot project ofDNAwise genetic test was conducted recently across 17 Indian cities. It was accepted very well amongst the consumers and they are now taking it for their family members. We have received a feedback that the report and recommendations are empowering them to live a happy and healthy life. Many are also taking the report to their doctors, fitness trainers and dieticians for more benefits and help in lifestyle personalization. DNAwiseis once-in-a-lifetime investment for health that is recommended for all family members to know the predisposition of diseases, followed by yearly health examination. The genetic test report can be the guide for one’s lifelong wellness. ]]> <![CDATA[Dr. Reddy’s announces the launch of Omeprazole Delayed-Release Tablets ]]> https://biospectrumindia.com/news/95/12239/dr-reddys-announces-the-launch-of-omeprazole-delayed-release-tablets-.html https://biospectrumindia.com/news/95/12239/dr-reddys-announces-the-launch-of-omeprazole-delayed-release-tablets-.html Tue, 11 Dec 2018 12:20:00 +0530 Dr. Reddy’s has announced the launch of Omeprazole Delayed-Release Tablets, 20 mg, an over-the-counter (OTC) store-brand equivalent of Prilosec OTC (omeprazole delayed-release) Tablets, 20 mg, in the United States market as approved by the U.S. Food and Drug Administration (USFDA). OTC Omeprazole Delayed-Release Tablets, 20 mg, is a proton pump inhibitor used to treat frequent heartburn occurring two or more days per week in adults. Milan Kalawadia, Vice President and Head, US OTC and Speciality Rx businesses, Dr. Reddy’s Laboratories said, "This launch illustrates our continued commitment to the OTC business as well as the depth and breadth of our OTC portfolio. We look forward to collaborating with our customers to provide high-quality, affordable alternatives to consumers.” Dr. Reddy’s Omeprazole Delayed-Release Tablets, 20 mg, is available in 14 count bottles sold in cartons of 1, 2, or 3 bottles each. Each bottle contains one complete 14-day course of treatment. ]]> <![CDATA[Lupin’s Pithampur Unit-3 receives EIR from USFDA ]]> https://biospectrumindia.com/news/95/12233/lupins-pithampur-unit-3-receives-eir-from-usfda-.html https://biospectrumindia.com/news/95/12233/lupins-pithampur-unit-3-receives-eir-from-usfda-.html Mon, 10 Dec 2018 18:25:00 +0530 Pharma major Lupin has announced the receipt of the Establishment Inspection Report (EIR) for its Pithampur (Unit 3) facility. The inspection at the site was conducted between June 12, 2017 and June 16, 2017. This was a Pre-approval inspection for Albuterol Sulfate Inhalation product. Commenting on the development, Nilesh Gupta, Managing Director, Lupin said, “The receipt of the EIR for our Pithampur Unit 3 is an encouraging development. This is a validation of our commitment to maintain the highest standards in quality and compliance across our facilities.” Lupin’s Pithampur (Unit 3) facility manufactures Dermatological Products, Dry Product Inhalers and Metered Dose Inhalers. ]]> <![CDATA[Over 8000 to participate in 70th Indian Pharma Congress]]> https://biospectrumindia.com/news/95/12228/over-8000-to-participate-in-70th-indian-pharma-congress.html https://biospectrumindia.com/news/95/12228/over-8000-to-participate-in-70th-indian-pharma-congress.html Mon, 10 Dec 2018 15:05:00 +0530 Indian Pharmaceutical Congress (IPC) is held every year in the country under the aegis of Indian Pharmaceutical Congress Association (IPCA) which is a federation of five professional pharmaceutical bodies, namely,Indian Pharmacy Graduates’ Association (IPGA) Indian Pharmaceutical Association (IPA), Association of Pharmaceutical Teachers of India (APTI), Indian Hospital Pharmacists’ Association (IHPA) and All India Drugs Control Officers’ Confederation (AIDCOC) This year IPGA, the national body of pharmacy graduates, is set to host the 70th session of the Indian Pharmaceutical Congress (IPC), the largest congregation of pharmacists and pharmaceutical professionals.IPGA, founded in 1973, undertakes to improve the professional status of pharmacy graduates and to secure their rightful positions in pharmacy and other allied professions. The 70th IPC will be inaugurated on December 21st by the Vice-President of India, Venkaiah Naidu, and presided by Dilip Shanghvi, President of 70th IPC and Managing Director of Sun Pharma. The three-day mega annual event is set to be held at Amity University, Noida, Delhi NCR from December 21 to 23, 2018, is set to attract more than 8,000 delegates this year from all the sections of the pharma fraternity. Dr Ashok K. Chauhan, Founder President, Amity Universities and Institutions.; along with R.C. Juneja,  Chairman, Mankind Pharma Ltd. who are the Chief Patrons of the 70th IPC will be present on the occasion along with Chairman of the Local Organizing Committee (LOC) B.R. Sikri and Organizing Secretary-LOC AtulNasa. With the rapid growth of the Indian pharma economy, which is expected to reach US $100 billion by 2025, the 70th edition of IPC selected its theme “Pharma Vision 2030: Indian Pharma Industry – A Global Leader". Commenting on the selection of the theme, DilipShanghvi, MD of Sun Pharma and President of 70th IPC, in a statement, said, “There is an urgent need to reinforce and rebuild standards with statutory bodies and to restore the confidence of  pharmacy graduates. The quality of education has to be improved by industrial participation so that the stakeholders are accepted in the global pharma industry. The regulatory policies of India are to be harmonized so that India becomes global leader in pharma, including generics, active pharmaceutical ingredients, medical devices and diagnostics.” Currently, the Indian pharmaceutical sector accounts for about 3.1-3.6% of the global pharma industry in value terms and 10% in volume terms.  Moreover, the Indian pharma industry is witnessing a market growth of 12.8% due to an increase in consumer spending, rapid urbanization, and  increase in healthcare insurance. Over the years, IPC has evolved as a platform for showcasing the progress made by pharma professionals in India. The unique feature of the IPC is that it has helped create more awareness of the pharmacy profession in the country. The 70th IPC, with its power-packed scientific programs is set to leave an indelible mark in the minds of pharma professionals, while demonstrating the latest advances in the pharma sector in the areas of drug development, manufacture and regulatory framework.The scientific sessions will delve into new frontiers of drug discovery, drug development, pharmaceutical regulations and other related fields. The event will see discourses on latest burning topics/challenges being faced by the pharma profession, which  include regulatory landscape of the Indian pharma industry; addressing talent gaps in the industry; India’s  dependence on cheaper APIs from China; mushrooming of e-pharmacies in  the country and its ripple effect on the brick and mortar stores; and  prescribing only generic drugs instead of branded generics. Moreover, the conference will help in disseminating scientific knowledge and facilitate exchange of new ideas among the members of the pharmacy profession.  Other focus areas include increasing leadership of the women working within the pharmacy profession, newly designed ‘Job Fair’ for student delegates, and a road-map for the Indian pharma industry to meet the demands of the most  ambitious health insurance scheme “Ayushman Bharat”. Based on discussions held during the congress and the problems faced by the pharmacy profession, resolutions are passed by the organizing Association and forwarded to the concerned authorities.  ]]> <![CDATA[Building an Inclusive Organisation Should Be a Priority for All Corporates: Dr. Azad Moopen]]> https://biospectrumindia.com/news/95/12221/building-an-inclusive-organisation-should-be-a-priority-for-all-corporates-dr-azad-moopen.html https://biospectrumindia.com/news/95/12221/building-an-inclusive-organisation-should-be-a-priority-for-all-corporates-dr-azad-moopen.html Sat, 08 Dec 2018 05:20:00 +0530 To commemorate International Day of Persons with Disabilities, Aster DM Healthcare organized an event called “Common Ground” for the differently abled employed with the Company across India and GCC. Hosted at Aster Medcity Hospital in Kochi, the event was held to recognize the efforts of differently abled individuals and highlight their contributions across the company. Broadcasted live across all Aster units globally, the event brought together the Company’s 17,700 employees on one platform to celebrate an inclusive culture. Speaking on the occasion, Dr. Azad Moopen, Founder Chairman and Managing Director of Aster DM Healthcare said, “I believe that every individual who has the passion to achieve their dreams and motivated to work-hard should be given an opportunity, without discrimination. Inclusion and diversity are a part of our ethos at Aster DM Healthcare and forms the basis of our strength as an organisation. We have seen individuals challenged with a disability, driven by sheer determination and hard-work excelling at their jobs. As such, we are further committing to include differently-abled as 1% of our total employee base across 9 countries. Let us encourage the differently-abled to become active participants in the society.” The event saw the presence of an inspirational speaker Preeti Monga, the Founder and CEO of the Silver Linings Trust & Silver Linings Services. Speaking on the occasion, Preeti Monga said, “Being differently abled should not be a hindrance in the path of your success. With the advent of technology and change in the corporate structure of organizations, inclusion is the new pillar of building a successful eco-system. Inclusion empowers us to be self-dependent and adds value to the organization. I am delighted to be a part of this great event and would want to wish all the best to the Asterians.” She has been visually impaired since age six. Through her various portfolios, she works for differently abled people, promotion of eye donation and empowerment of women. Out of the 108 differently abled employees at Aster DM Healthcare, 63 are based across Aster India’s 11 hospitals and the remaining 45 are based in GCC and other countries. Initiated as a part of Aster Volunteers Global Programme, the initiative aims to make a sustainable impact in the lives of people. ]]> <![CDATA[Pharma torch bearers congregate to select industry’s best in class in Mumbai]]> https://biospectrumindia.com/news/95/12217/pharma-torch-bearers-congregate-to-select-industrys-best-in-class-in-mumbai.html https://biospectrumindia.com/news/95/12217/pharma-torch-bearers-congregate-to-select-industrys-best-in-class-in-mumbai.html Fri, 07 Dec 2018 20:00:00 +0530 The India Pharma Awards, conducted by UBM India, India’s leading B2B exhibitions organizer, concluded the second and final round of jury selection at The Lalit, Mumbai recently. The Awards follow a two-step judging process that has been highly appreciated by both, jury and participants, and it has strengthened the evaluation process, pulling in nominees of extremely high calibre. An esteemed jury panel including industry thought leaders such as Bhalchandra G. Barve, Joint Managing Director of Blue Cross Laboratories Ltd.; Lion Daara B. Patel, Secretary-General Indian Drug Manufacturers Association; Sunil Bambarkar, Managing Director, Gattefosse India Pvt Ltd; Subodh Priolkar, CEO, Wincoat Colours & Coatings; S M Mudda, Director Global Strategy, Microlabs and Dr R B Smarta, Secretary, HADSA were present today to select the winners after judging presentations more than 65 nominations from among companies such as  Cipla Ltd,  Dr. Reddy’s Laboratories Ltd., Abbott Healthcare Pvt Ltd,  Fermenta Biotech Limited, Parle Global Technologies Pvt. Ltd.,  ACG and Clariant Healthcare Packaging  The IPA is conducted methodically with a process driven robust approach in partnership with Process Advisors, EY that involves a neutral jury which comprises industry think tanks who have championed the cause of their chosen domain expertise within the pharma sector. The winners will be formally recognized and rewarded at the India Pharma Awards and Networking Night on December 12, 2018 at the India Expo Centre, Greater Noida, as a part of the much feted India Pharma Week.  As announced earlier, UBM India, India's leading B2B exhibition organizer, is all set to bring in the third edition of the widely appreciated India Pharma Week, alongside the 12th edition of its flagship expo CPhI and P-MEC India at the India Expo Centre, Greater Noida, Delhi-NCR.  While the 6th edition of the India Pharma Awards is going to be held in the Delhi-NCR region for the first time, as a tribute to the city in which it was born and reared, the selections happened in Mumbai. India Pharma Awards, one of the most transparent & process driven awards are conducted professionally as well as methodically to draw out the best in the industry, and it stands as an opportunity to position your brand with the best in the Pharmaceutical space. This is done with a neutral Jury Panel representing various segments of the industry. ]]> <![CDATA[Schrödinger, SPARC to accelerate CNS drug development]]> https://biospectrumindia.com/news/95/12216/schrdinger-sparc-to-accelerate-cns-drug-development.html https://biospectrumindia.com/news/95/12216/schrdinger-sparc-to-accelerate-cns-drug-development.html Fri, 07 Dec 2018 18:05:00 +0530 Schrödinger and Sun Pharma Advanced Research Company Ltd. (SPARC) have announced a research collaboration to accelerate the discovery of novel CNS therapeutics by leveraging Schrödinger’s advanced computational platform and SPARC’s extensive drug development expertise and insights in neurodegeneration. Schrödinger, a privately held company committed to revolutionizing drug discovery through advanced molecular simulation, will focus on lead discovery and optimization. SPARC, a clinical-stage company focused on improving patient care through innovation, will be responsible for compound synthesis and assays. “This research collaboration is particularly exciting because neurodegeneration is an area where we urgently need more options for patients through novel approaches to drug discovery and development,” said Ramy Farid, Ph.D., president and CEO of Schrödinger. “SPARC has been working with leading academic researchers to explore pathways relevant to disorders of the central nervous system, and their insights are quite compelling. Teaming up will allow us to rapidly interrogate therapeutic compounds that target these pathways.” “We have used Schrödinger’s software for years and have experienced directly the power of their physics-based approaches to computational modeling, so we’re delighted to form a collaboration that lets us tap into the expertise of their drug discovery team as well,” said Anil Raghavan, CEO of SPARC. “At SPARC, we’re committed to fueling innovation through both internal R&D and strategic partnerships with industry leaders, and this collaboration is a strong step in that direction. By working together, we can greatly accelerate the pace of innovation.” ]]> <![CDATA[Novartis India MD to step down ]]> https://biospectrumindia.com/news/95/12211/novartis-india-md-to-step-down-.html https://biospectrumindia.com/news/95/12211/novartis-india-md-to-step-down-.html Fri, 07 Dec 2018 11:30:00 +0530 Drug firm Novartis India recently announced that its Vice Chairman and Managing Director Milan Paleja has decided to step down from company, with effect form May 31, 2019. According to the company statement, “Paleja has informed the company's board of his decision to resign as the vice chairman and managing director effective May 31, 2019 for embracing challenges outside of Novartis.” The company board is now identifying a suitable successor for the role.   ]]> <![CDATA[Shire launches DosEdge in India ]]> https://biospectrumindia.com/news/95/12205/shire-launches-dosedge-in-india-.html https://biospectrumindia.com/news/95/12205/shire-launches-dosedge-in-india-.html Thu, 06 Dec 2018 18:45:00 +0530 Shire India, a leading global biotechnology company focused on serving people with rare diseases, has announced the availability of DosEdge. The new free mobile app aids healthcare professionals in determining the appropriate dosage of antihemophilic factor/drug. Currently, healthcare professionals manually calculate factor dosage and frequency use variables like severity level, bleeding spot, patient’s body weight, and the treatment type – prophylactic or on-demand. Missing any of the parameters may lead to sub-optimal treatment. DosEdge safeguards dosage accuracy and reduces the incidence of error, thereby helping physicians develop personalized dosing regimens tailored to specific needs of their respective patients. The app is available to healthcare professionals through the Apple App Store and Google Play Store. The app is free, does not require an active internet connection, has a simple user interface and needs minimal data inputs. However, the app uses data analysis to make accurate and critical dosage calculations for factor replacement. With just a few clicks, the app enables healthcare professionals to assess their patients’ accurate factor dosage requirement and helping them retain full control over their prescription practice. “As part of our commitment to meeting the unmet needs of hemophilia patients, we are pleased to introduce DoseEdge, an innovative mobile app for healthcare professionals in India.” said Vineet Singhal, Country Head, Shire India. Hemophilia is a lifelong bleeding disorder in which patients do not have enough clotting factor, a naturally occurring protein in blood that controls bleeding. People with Hemophilia do not bleed more profusely or faster than normal, but bleed for a longer period of time. The disease primarily affects males, and with about 1 in 5,000 people being born with the condition. Alugh there is no cure, patients with Hemophilia typically receive a treatment called “factor replacement therapy” to help their blood clot (the body’s normal process to stop bleeding). ]]> <![CDATA[Lupin launches generic Silodosin Capsules 4mg and 8mg]]> https://biospectrumindia.com/news/95/12196/lupin-launches-generic-silodosin-capsules-4mg-and-8mg.html https://biospectrumindia.com/news/95/12196/lupin-launches-generic-silodosin-capsules-4mg-and-8mg.html Thu, 06 Dec 2018 09:25:00 +0530 Lupin announced the launch of Silodosin Capsules 4mg and 8mg, having received an approval from the United States Food and Drug Administration (FDA) earlier. Lupin's Silodosin Capsules 4mg and 8mg; is the generic equivalent of Allergan's Rapaflo®. An alpha-1 adrenergic receptor antagonist, it is indicated for the treatment of the signs and symptoms of benign prostatic hyperplasia (BPH). Rapaflo® had annual sales of $198.5 million in the US (IQVIA MAT September 2018). ]]> <![CDATA[USFDA completes inspection of Lupin’s Mandideep location]]> https://biospectrumindia.com/news/95/12195/usfda-completes-inspection-of-lupins-mandideep-location.html https://biospectrumindia.com/news/95/12195/usfda-completes-inspection-of-lupins-mandideep-location.html Thu, 06 Dec 2018 09:20:00 +0530 Lupin has announced the completion of United States Food and Drug Administration (US FDA) inspections carried out at its Mandideep location. Lupin’s Mandideep location houses the company’s cardiovascular “Pril” API facilities, Cephalosporin API facilities and Cephalosporin Solid Oral Dosage Form facility. These inspections were carried out between November 26 and December 4, 2018. The inspection at Unit-2, the Cardiovascular “Pril” API facilities closed with 4 observations. The inspection at Unit-1, the Cephalosporin facilities closed with 10 observations for the Cephalosporin API facilities and 8 observations for the Cephalosporin Solid Oral Dosage Form facility. The observations are largely procedural in nature with some gaps identified in the aseptic processing areas of the Cephalosporin API block and the company is confident of addressing them satisfactorily.   ]]> <![CDATA[Alembic Pharma gets USFDA nod for hypertension drug]]> https://biospectrumindia.com/news/95/12193/alembic-pharma-gets-usfda-nod-for-hypertension-drug.html https://biospectrumindia.com/news/95/12193/alembic-pharma-gets-usfda-nod-for-hypertension-drug.html Wed, 05 Dec 2018 20:45:00 +0530 Alembic Pharmaceuticals Limited has announced that the Company has received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Candesartan Cilexetil Tablets USP, 4 mg, 8 mg, and 16 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Atacand Tablets, 4 mg, 8 mg, and 16 mg, of ANI Pharmaceuticals, Irie. Candesartan cilexetil tablets are indicated for the treatment of hypertension in adults and in children 1 to <17 years of age to lower blood pressure. Candesartan cilexetil tablets also indicated for the treatment of heart failure. Candesartan Cilexetil Tablets USP, 4 mg, 8 mg, and 16 mg, hzve an estimated market size of $ 22 million for twelve months ending December 2017 according to IQVIA. Alembic has a cumulative total of 82 ANDA approvals (69 final approvals and 13 tentative approvals) from USFDA.         ]]> <![CDATA[Orit Labs receives USFDA approval for peptic ulcer therapy]]> https://biospectrumindia.com/news/95/12181/orit-labs-receives-usfda-approval-for-peptic-ulcer-therapy.html https://biospectrumindia.com/news/95/12181/orit-labs-receives-usfda-approval-for-peptic-ulcer-therapy.html Wed, 05 Dec 2018 10:40:00 +0530 Alembic Pharmaceuticals Limited recently announced its wholly owned subsidiary Orit Laboratories LLC has received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Glycopyrrolate Tablets USP, 1 mg and 2 mg. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Robinul and Robinul Forte Tablets, 1 mg and 2 mg, of Casper Pharma LLC (Casper Pharma). Glycopyrrolate Tablets are indicated for use as adjunctive therapy in the treatment of peptic ulcer. Glycopyrrolate Tablets USP, 1 mg and 2 mg have an estimated market size of $ 15 million for twelve months ending December 2017 according to IQVIA. Alembic has a cumulative total of 81 ANDA approvals (68 final approvals and 13 tentative approvals) from USFDA. ]]> <![CDATA[Third edition of India Pharma Week gears up for debut in Delhi-NCR]]> https://biospectrumindia.com/news/95/12178/third-edition-of-india-pharma-week-gears-up-for-debut-in-delhi-ncr.html https://biospectrumindia.com/news/95/12178/third-edition-of-india-pharma-week-gears-up-for-debut-in-delhi-ncr.html Tue, 04 Dec 2018 16:45:00 +0530 UBM India, India's leading B2B exhibition organizer, is all set to bring in the third edition of the widely appreciated India Pharma Week, a week-long celebration packed with avant-garde events from 9th – 14th December, alongside the 12th edition of its flagship expo CPhI and P-MEC India. South Asia’s largest Pharma event will be held for the first time at the world class venue of the India Expo Centre, Greater Noida, with all its attendant facilities, moving away from the commercial capital of Mumbai. This will enable all the key stakeholders and professionals of the pharma industry the convenience to congregate at the marquee show, network and celebrate the industry under one giant umbrella for an entire week. Commemorating the 12 years of the CPhI & P-MEC India expo, the India Pharma Week will organize more than 7 events and activities pertaining to the streams of business, knowledge, leadership, innovation, recognition and networking in the field of Pharma. As a tribute to the city in which it was born and reared, the India Pharma Week will tee off with a Pharma Leaders Golf in Mumbai. The scene of action will then shift to Greater Noida where the IPW will be packed with a series of dynamic engagements such as Pharma Connect Congress, Women in Pharma, India Pharma Awards, Networking Evening, the CPhI & P-MEC India Exhibition and a closed-door CEO Roundtable, among others. The shift to the Delhi-NCR region will help the magnum opus further develop and nurture a complete pharma ecosystem in the sectoral pockets of the North, also keeping in mind its power corridors. Originally Incepted in 2006, the CPhI & P-MEC India exhibition has grown remarkably larger over the years with exhibitors and visitors from Indian and overseas engaging over significant levels of business. It has been approved and comprehensively assisted in its endeavors by governing bodies such as Pharmexcil, CIPI and IDMA. This year's edition will witness participation from more than 1,600 exhibitors from over 42 countries. Special pavilions by Pharmaceuticals Export Promotion Council of India (Pharmexcil), China Chamber of Commerce for Import & Export of Medicines & Health Products (CCCMHPIE) and China Council for the Promotion of International Trade (CCPIT) will form an intrinsic part of the expo. The India Pharma Week with its mélange of events was launched in 2016 to celebrate CPhI & P-MEC’s ten years of existence. Onsite, several innovative engagement platforms such as Supplier Finder, CPhI TV, Live Streaming, Mobile Apps, Tech Walls, Matchmaking - Live Pharma Connect, Exhibitor Showcase, and Innovation Gallery among others are sure to make the visitor experience an engaging and memorable one. Speaking on IPW 2018, Yogesh Mudras, Managing Director, UBM India said, “I am delighted to announce the third edition of the weeklong India Pharma Week -- an unrivalled offering to the world of exhibitions -- along with the CPhI & P-MEC India, UBM’s flagship engagement platform, and the world’s leading Pharmaceutical networking event in the Delhi-NCR region at a world class venue that an elite congress such as the one at IPW richly deserve. The shift to the region, in close geographical proximity to the Centre, policy makers, consulates and government bodies will enhance our community building efforts. Apart from the business, and the medley of captivating events, key discussion areas will include ‘Growth of Indian Pharmaceutical industry: Vision 2020’, ‘Transforming the Pharma industry architecture through collaborations’, and ‘Strategies to strengthen regulatory policies in India’ among many others, for the community to ruminate and act upon,”.  “With an estimated spend of over US$ 200 billion on medical infrastructure in the next decade; India is keen to make drugs affordable as well as available in all corners of the country. What is also equally required to make India a global leader in end to end pharma manufacturing, as encapsulated by The ‘Pharma Vision 2020' is a heightened appreciation and awareness about compliance requirements and investment in R&D. These factors seem to have been comprehended by the pharma community with around 9 per cent of sales by organisations being re-invested in R&D and 46 mergers having been affected in 2017-18. These will, no doubt, go a long way in leading the country on to further innovation, discovery and patents to maintain its stronghold over the sector,” he further added   Events under IPW: Pharma Leaders Golf: Scheduled for 9th December, this off-the-beaten track event will have leaders from top pharmaceutical companies getting together over a game of Golf. Around 25 chiefs will tee off under the balmy winter sun for a fun and networking day. Innumerable business opportunities and contacts will be built over a friendly round of golf – a perfect way to warm-up a few days before the grand CPhI & P-MEC India exhibition begins. CPhI & P-MEC: As the pharma industry is increasingly looking towards India for high quality, low cost pharma solutions, CPhI & P-MEC India is the perfect event for companies to pick up on the latest trends and innovations the market has to offer. The event is scheduled for 12th – 14th December, and enables attendees to meet the movers and shakers in India’s pharma machinery, technology and ingredients industry for a competitive advantage that will help grow your business. India Pharma Awards and Networking Night: The grand stage of India Pharma Awards is back in its 6th year to celebrate the advances & achievements of the Indian Pharmaceutical Industry on 12th December 2018. A part of the Recognition & Networking stream, India Pharma Awards 2018 will bring together industry champions, stalwarts & visionaries from around the world. The journey for the awards has proved to be interesting with increased number of nominations, partnerships and audience footfalls year-on-year. India Pharma Awards is not only a platform for the pharma companies in the country but also a platform that honours individual achievements within those companies, hence, serving as the best platform for the universe of pharma. India Pharma Awards, one of the most transparent & process driven awards are conducted professionally as well as methodically to draw out the best in the industry, and it stands as an opportunity to position your brand with the best in the Pharmaceutical space. This is done with a neutral Jury Panel representing various segments of the industry. Pharma Connect Congress: India’s pharma market is set to outperform the global industry. To boost the sector further, with the theme of ‘Ideate. Innovate. Integrate’, the Pharma Connect Congress will work cohesively towards achieving the Pharma Vision of making India the next major hub of end-to-end drug discovery. The event is scheduled for 12th December 2018 and the topics of discussion will include ‘Transforming the Pharma Industry Architect Through Collaborations’, ‘Strategies to Strengthen Regulatory Policies in India’, ‘Role of Digitalization in Transforming the Pharmaceutical Sector’ and ‘Leveraging Latest Innovations in Technology’ amongst others. CEO Roundtable: For the last 2 years, this has been known as the one of the marquee events of IPW. In the 3rd edition, which is scheduled for 12th December, the exclusive, closed door CEO Roundtable has been eminently successful as a strategic gathering of CEOs of leading pharma companies who will deep dive into thought-provoking discussions. Women Leaders in Pharma: This summit celebrates the does and the doing – an initiative aimed at acknowledging and celebrating the significant and continued contribution of women to the pharma industry. Scheduled for 13th December, it will bring women luminaries from around the world on a common platform to share their success stories, experiences and knowledge. Revolving on 3 core pillars; leadership, entrepreneurship and gender diversity, the 3rd edition of Women in Pharma will feature scintillating discussions like ‘Can Women have it all? Balancing Life and Work’ and ‘Strategies to Make our Organizations More Diverse and Adopting Inclusive Leadership’ amongst many more. ]]> <![CDATA[Glenmark receives tentative ANDA approval for Clobetasol Propionate Foam]]> https://biospectrumindia.com/news/95/12170/glenmark-receives-tentative-anda-approval-for-clobetasol-propionate-foam.html https://biospectrumindia.com/news/95/12170/glenmark-receives-tentative-anda-approval-for-clobetasol-propionate-foam.html Mon, 03 Dec 2018 15:45:00 +0530 Glenmark Pharmaceuticals Inc., has been granted tentative approval by the United States Food & Drug Administration (U.S. FDA) for Clobetasol Propionate Foam, 0.05% (Emulsion Formulation). It is a generic version of Olux-E®1 Foam, 0.05%, of Mylan Pharmaceuticals, Inc. According to IQVIATM sales data for the 12 month period ending September 2018, the Olux-E® Foam, 0.05% market2 achieved annual sales of approximately $13.2 million. Glenmark’s current portfolio consists of 144 products authorized for distribution in the U.S. marketplace and 55 ANDAs pending approval with the U.S. FDA. In addition to these internal filings, Glenmark continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio. ]]> <![CDATA[Sun Pharma gets USFDA nod for generic Ganirelix Acetate Injection]]> https://biospectrumindia.com/news/95/12167/sun-pharma-gets-usfda-nod-for-generic-ganirelix-acetate-injection.html https://biospectrumindia.com/news/95/12167/sun-pharma-gets-usfda-nod-for-generic-ganirelix-acetate-injection.html Mon, 03 Dec 2018 12:35:00 +0530 Sun Pharmaceutical Industries Ltd., a generic pharmaceutical company today announced that it has received final approval from US FDA for its Abbreviated New Drug Application (ANDA) for a generic version of Ganirelix Acetate Injection, 250 mcg/0.5 mL. The generic version is therapeutic equivalent to Organon’s Ganirelix Acetate Injection, 250 mcg/0.5 mL. As per IQVIA, Ganirelix Acetate Injection, 250 mcg/0.5 mL had annual sales of approximately US$ 67 million in the US for the 12 months ended September 2018. The commercialization of this product in the US market is expected in Q4FY19. ]]> <![CDATA[CPhI report: India with strongest global growth in 2019]]> https://biospectrumindia.com/news/95/12162/cphi-report-india-with-strongest-global-growth-in-2019.html https://biospectrumindia.com/news/95/12162/cphi-report-india-with-strongest-global-growth-in-2019.html Mon, 03 Dec 2018 10:25:00 +0530 CPhI & P-MEC India, organised by UBM, is set to open its doors to more than 40,000 attendees from 120+ countries and 1500 exhibitors, as new analysis shows a massive improvement in India’s global reputation. The India specific findings of the CPhI Annual Report highlight that India has seen significant jump across all (six) categories, improving its overall score by a massive 11.06% in a single year. The country showed the largest gains in terms of perceived ‘quality of API’ and ‘finished product’ manufacturing, proving that industry efforts to align standards more closely with the USA and Europe have clearly been noted. But perhaps most significantly, these efforts are also being transferred into reported growth potential for 2019, with India forecast to grow faster than all other major pharma economies, scoring an average of 7.16 – placing it ahead of the USA (7.04) and China (6.81). Survey respondents cited India’s ‘high-growth domestic market’ and ‘expanding manufacturing exports’ as the major drivers. The rise in exports growth potential is believed to be in response to concerted reforms by the CDSCO (Central Drugs Standard Control Organisation) and industry quality improvements in the last few years. Such was the confidence in India’s pharma market, the nation was ranked joint second for ‘overall competitiveness’ of its pharma industry. India scored an average of 6.53, placing it behind only the US (6.98) and level with Germany (6.53). In addition to this, India saw the largest percentage shift in score for quality of finished formulations, improving by 14.72% since 2017. Most impressively, should the same change be seen in 2019, the country’s reputation for finished product manufacturing will likely see it achieve parity with many European nations (who’s scores have remained the same year-on-year) – a dramatic improvement on just a few years ago. With these hugely positive results as its backdrop, the 12th Annual CPhI & P-MEC India will take place on 12th-14th December 2018, alongside India Pharma week (9th- 14th December). To help further drive forward the market’s growth potential, the event has moved to the Indian capital, taking place at Delhi’s India Expo Centre, Greater Noida, and will return to single venue format. These changes are expected to bring a wider international audience, help more closely integrate vital regulatory pathways into the events content, and allow an even more diverse cross-pollination of partnerships – meaning visitors can meet with API suppliers, distributors, contract providers and machinery specialists all in the same morning. In keeping with the international nature of this regional hub, India Pharma Week once again returns for its third edition, with five events running from December 9th until the 14th – including the Pharma Connect Congress, the India Pharma Awards, CEO Roundtable, Networking Evening and Women in Pharma panel amongst others. “What has been achieved in this country in the last decade is truly remarkable, and it’s clear from the sentiments we hear in the market that we are set for another wave of significant growth and advancement over the next few years. It’s undoubtedly a hugely exiting time for anyone looking to do business in this region.. There is a notable excitement about CPhI & P-MEC India this year, and the feedback we get from visitors and exhibitors is that they have an extremely confident outlook for 2019 – with all looking for new partners to help drive the country’s next wave of growth. This, coupled with a new single-site location at the India ExpoCentre, will deliver economies of scale and more partnerships and networking opportunities at this event than ever before.” Cara Turner, Brand Director – Pharma at UBM (part of Informa PLC). Highlights from this year’s pharma connect congress include sessions on topics as diverse as ‘transforming the pharma industry architecture through collaborations’, ‘strategies to strengthen regulatory policies in India’, ‘efficient clinical trial data management’, ‘winning with biosimilars’ and ‘leveraging latest innovations in technology’. Finally, this year will also feature the third annual Women in Pharma Summit, which will deliver keynote addresses and panel discussions revolving around leadership, entrepreneurship and gender diversity. ]]> <![CDATA[Lupin launches generic Nystatin and Triamcinolone Acetonide Cream ]]> https://biospectrumindia.com/news/95/12155/lupin-launches-generic-nystatin-and-triamcinolone-acetonide-cream-.html https://biospectrumindia.com/news/95/12155/lupin-launches-generic-nystatin-and-triamcinolone-acetonide-cream-.html Fri, 30 Nov 2018 14:50:00 +0530 Pharma company Lupin has announced the launch of Nystatin and Triamcinolone Acetonide Cream USP 100,000 units/gm; 0.1 %, having received an approval from the United States Food and Drug Administration (FDA) earlier. Lupin's Nystatin and Triamcinolone Acetonide Cream USP 100,000 units/gm; 0.1 % is the generic equivalent of Taro Pharmaceuticals' Nystatin and Triamcinolone Acetonide Cream. It is indicated for the treatment of cutaneous candidiasis. Nystatin and Triamcinolone Acetonide Cream had annual sales of $54.3 million in the US (IQVIA MAT September 2018).   ]]> <![CDATA[Baclofen by Zydus gets USFDA approval]]> https://biospectrumindia.com/news/95/12151/baclofen-by-zydus-gets-usfda-approval.html https://biospectrumindia.com/news/95/12151/baclofen-by-zydus-gets-usfda-approval.html Fri, 30 Nov 2018 10:50:00 +0530 Pharma company, Zydus Cadila has received the final approval from USFDA to market Baclofen Tablets(US RLD- Lioresal) 10 mg and 20 mg. According to the company statement, “It will be manufactured at the group’s formulations manufacturing facility at Baddi.” Baclofen is used to treat muscle spasms caused by certain conditions such as multiple sclerosis, spinal cord injury/disease. It works by helping to relax the muscles.  With this approval, Zydus now has 234 approvals and has so far filed over 340 ANDAs since the commencement of the filing process in FY 2003-04.  ]]> <![CDATA[Dr. Reddy's launches Chlorthalidone Tablets in the U.S. Market]]> https://biospectrumindia.com/news/95/12144/dr-reddys-launches-chlorthalidone-tablets-in-the-u-s-market.html https://biospectrumindia.com/news/95/12144/dr-reddys-launches-chlorthalidone-tablets-in-the-u-s-market.html Thu, 29 Nov 2018 22:20:00 +0530  Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, along with its subsidiaries together referred to as “Dr. Reddy’s”) today announced the launch of Chlorthalidone Tablets USP, 25 mg and 50 mg, a therapeutic equivalent generic version of Hygroton (chlorthalidone) Tablets, approved by the U.S. Food and Drug Administration (USFDA). The Hygroton brand and generic had U.S. sales of approximately $122 million MAT for the most recent twelve months ending in September 2018 according to IMS Health*.  Dr. Reddy’s Chlorthalidone Tablets, USP are available in 25 mg tablets in the bottle-count sizes of 100 and 1000, and 50 mg tablets in the bottle-count size of 100. ]]> <![CDATA[Dr. Reddy's Laboratories announces the launch of Chlorthalidone Tablets in U.S.]]> https://biospectrumindia.com/news/95/12140/dr-reddys-laboratories-announces-the-launch-of-chlorthalidone-tablets-in-u-s-.html https://biospectrumindia.com/news/95/12140/dr-reddys-laboratories-announces-the-launch-of-chlorthalidone-tablets-in-u-s-.html Wed, 28 Nov 2018 15:40:00 +0530 Dr. Reddy’s Laboratories Ltd. has announced the launch of Chlorthalidone Tablets USP, 25 mg and 50 mg, a therapeutic equivalent generic version of Hygroton (chlorthalidone) Tablets, approved by the U.S. Food and Drug Administration (USFDA). The Hygroton brand and generic had U.S. sales of approximately $122 million MAT for the most recent twelve months ending in September 2018 according to IMS Health. Dr. Reddy’s Chlorthalidone Tablets, USP are available in 25 mg tablets in the bottle-count sizes of 100 and 1000, and 50 mg tablets in the bottle-count size of 100. ]]> <![CDATA[Lupin CFO Ramesh Swaminathan quits]]> https://biospectrumindia.com/news/95/12139/lupin-cfo-ramesh-swaminathan-quits.html https://biospectrumindia.com/news/95/12139/lupin-cfo-ramesh-swaminathan-quits.html Wed, 28 Nov 2018 15:00:00 +0530 Ramesh Swaminathan, Chief Financial Officer of Lupin Pharma has decided to quit the company to pursue opportunities outside of pharmaceutical industry. He was part of Lupin for the last 12 years where he was also a whole time director. Swaminathan was part of some of company's biggest mergers and acquisition. Swaminathan joined Lupin in August 2007 and has been its executive director since October 27, 2015. The company is yet to announce a replacement for Swaminathan. ]]> <![CDATA[Pricing pressure in US generic pharma market to normalise soon: ICRA]]> https://biospectrumindia.com/news/95/12135/pricing-pressure-in-us-generic-pharma-market-to-normalise-soon-icra.html https://biospectrumindia.com/news/95/12135/pricing-pressure-in-us-generic-pharma-market-to-normalise-soon-icra.html Wed, 28 Nov 2018 11:40:00 +0530 Indian pharma companies with significant presence in the US generic business have been grappling with slow growth as a result of intense US generics pricing pressure and thereby eroding operating profits, are likely to see favourable times in the next 12-15 months. As per an ICRA report, covering a sample of seven large Indian pharma companies, the US generic pricing pressure is expected to normalise, going back   to earlier levels of low to mid-single digit. Positive and selective price changes too are not ruled out. This is as against the low teens pricing pressure seen during CY2017 and 10-12% estimated by ICRA during CY2018. Elaborating further, Gaurav Jain, Vice President, Corporate Sector ratings, ICRA says, “The competitive intensity of US generic business and the pricing pressure thereof was due to the consolidation in distribution supply chain and monopolistic conditions, with three large buying group controlling 90% of the distribution channel. This coupled with the faster pace of ANDA approvals adopted by USFDA too has played its part. Consequently, the US generic business which has been a significant contributor to growth and profitability for Indian pharma players over the last decade faced slowdown registering growth of 4.0%, -13.1%, 1.5% in FY2017, FY2018 & Q1FY2019 respectively.” The faster pace of ANDA approvals by USFDA impacted generic prices thereby increasing competitive intensity. ANDA approvals rose from 409 in FY2014 (October to September period) to 763 and 781 in FY2017 and FY2018 respectively. The pace increased because in October 2012, the Generic Drug User Fee Act (GDUFA) was implemented in the US leading to increased pricing pressure. Before GDUFA, while the average approval time was 36 months, under GDUFA, action on 90% of the standard ANDAs submitted needs to be taken within 10 months and; for priority ANDAs, the timelines has been reduced to 8 months subject to meeting certain requirements. Priority ANDAs are those drugs that have less than three approved generics or Para IV filings among others. The USFDA has already issued draft guidelines to promote entry of complex generics such as complex transdermal and topical and is further expected to issue guidelines for injectables, metered dose inhalers, peptides under the Drug Competition Action Plan thereby simplifying the scientific evidence required to show bioequivalence. The aftermath of this measure is that while higher ANDA approvals leads to high competitive intensity, mid and large size pharma companies will be selective in new launches owing to inadequate profitability, enabling normalisation of prices to some extent. Already between October to September in FY2018, companies have withdrawn 606 approved ANDAs, as compared to 214 and 248 withdrawals in FY2017 and FY2016 respectively. ICRA note says that, domestic pharma players have exited several products where pricing was unsustainable in the last 12-15 months; the freed capacities have been realigned for manufacturing higher volumes of existing products having strong market, so as to benefit from economies of scale or for new product introductions. The initiatives are likely to reduce competitive pressures and normalise prices. On the R&D front, companies are rationalising their spending by dropping plain vanilla generics development where there are already several ANDA filers awaiting approval or existing competition is high. They are instead focussing their spends towards complex generics, specialty products including NCEs (New Chemical Entities) & NTEs (New Therapeutic Entities) and bio-similars where less competition is expected. Players are progressively focusing on developing value-added generics (NTEs) by combining drugs, new route of administration or dosage form which allows them certain exclusivity and at the same time the risk reward ratio is more favourable. These drugs are improved or enhanced version of approved drugs. The average R&D cost (as a %age to sales) has reduced from 9.0% in FY2017 to 8.8% in FY2018 and 8.6% in Q1FY2019 for ICRA’s sample and is expected to remain at similar levels. Companies operating profits which fell from 26-28% till Q3FY2017 to current 19.0-21.0% has been cushioned by the cost reduction exercise, undertaken across various expense heads SG&A (selling, general and administrative expenses), R&D as well as employee cost. This has resulted from streamlining of product portfolio and manufacturing facilities. “Going forward, the profitability will get support from new launches and thereby the impact of on-going pricing pressure will be absorbed. ICRA expects significant reduction in prices will render the US generic business unattractive for many players enabling stabilisation and positive price changes in the medium term. Further, Indian companies having pipeline of complex generics will benefit from faster approval cycle and higher margins before other complex generics entry intensify pricing pressure. All these initiatives combined are likely to reduce competitive pressures enabling normalisation of prices and; will auger well for the Indian pharma players in the medium term,” concludes Jain. ]]> <![CDATA[Tarapur facility of Lupin receives EIR from USFDA ]]> https://biospectrumindia.com/news/95/12133/tarapur-facility-of-lupin-receives-eir-from-usfda-.html https://biospectrumindia.com/news/95/12133/tarapur-facility-of-lupin-receives-eir-from-usfda-.html Wed, 28 Nov 2018 10:55:00 +0530 Lupin has announced the receipt of the Establishment Inspection Report (EIR) on the completion of an inspection by the US FDA (United States Food & Drug Administration) at its facility in Tarapur, Maharashtra. The inspection conducted between August 27 and August 31, 2018 concluded with one inspectional observation. Commenting on the development, Nilesh Gupta, Managing Director, Lupin said, “For Lupin, meeting and exceeding global quality and procedural standards has always been paramount. We are committed to upholding the highest levels of quality and compliance standards across all our facilities.” This facility was founded in 1992 and is a state-of-the-art unit for manufacturing Active Pharmaceuticals Ingredients (API), both fermentation-based and synthetic.   ]]> <![CDATA[Merck grabs two R&D 100 Awards]]> https://biospectrumindia.com/news/95/12131/merck-grabs-two-rd-100-awards.html https://biospectrumindia.com/news/95/12131/merck-grabs-two-rd-100-awards.html Wed, 28 Nov 2018 10:25:00 +0530 Merck, a leading science and technology company has won two R&D 100 Awards. The 56th annual R&D 100 Awards program, honoring the 100 most innovative and significant technologies introduced in the past year, recognized Merck for its BioReliance® Viral and Gene Therapy Assay Portfolio and proxy-CRISPR technology. Merck has received nine R&D 100 Awards in the past six years. "We are honored to receive two R&D 100 Awards, one recognizing our continuous focus on making gene therapy more widely accessible to patients in need by developing and implementing our BioReliance®Viral and Gene Therapy assays rapidly," said Udit Batra, member of the Merck Executive Board and CEO, Life Science. He stated further, “The second award highlights Merck as a market leader in gene editing — the result of our longstanding R&D focus on CRISPR technology. I am immensely proud of our teams, who, every day, live our purpose to solve the toughest problems in life science." Merck's BioReliance® Viral and Gene Therapy Assay Portfolio won a R&D 100 Award in the Analytical/Test category. The BioReliance® Viral and Gene Therapy Assay Portfolio is a platform of assays that allows the timely release of viral and gene therapy vectors, cutting testing time nearly in half, while providing accurate and reliable results. Merck developed the assays specifically for viral gene therapy product characterization, purity, potency, safety and release testing. Merck's proxy-CRISPR technology won a Special Recognition Market Disruptor --Products award. Market disruptor awards are given to those that have the potential to be "game changers," disrupting established technologies and transforming their respective industry. Proxy-CRISPR is a new genome-editing tool for improving the performance of other newly discovered CRISPR proteins. This technology makes CRISPR more efficient, flexible and specific by opening up the DNA helix so researchers can make targeted sequence changes in previously inaccessible regions of the genome. Merck's proxy-CRISPR provides a rapid and simple method to increase usability without the laborious need to re-engineer native CRISPR proteins. The R&D 100 Awards are among the most prestigious innovation awards, honoring research and development pioneers.   ]]> <![CDATA[FDA approves Lupin's KCl for Oral Solution 20 mEq ]]> https://biospectrumindia.com/news/95/12122/fda-approves-lupins-kcl-for-oral-solution-20-meq-.html https://biospectrumindia.com/news/95/12122/fda-approves-lupins-kcl-for-oral-solution-20-meq-.html Tue, 27 Nov 2018 11:10:00 +0530 Pharma company Lupin has announced that it has received approval for its Potassium Chloride for Oral Solution USP, 20 mEq from the United States Food and Drug Administration (FDA) to market a generic version of Pharma Research Software Solution LLC’s Potassium Chloride for Oral Solution, 20 mEq. Lupin’s Potassium Chloride for Oral Solution USP, 20 mEq is the generic version of Pharma Research Software Solution, LLC’s Potassium Chloride for Oral Solution, 20 mEq. It is indicated for the treatment and prophylaxis of hypokalemia with or without metabolic alkalosis, in patients for whom dietary management with potassium-rich foods or diuretic dose reduction is insufficient. Potassium Chloride for Oral Solution USP, 20 mEq had annual sales of approximately USD 105 million in the US (IQVIA MAT September 2018).   ]]> <![CDATA[Clomipramine HCl Capsules by Lupin approved by FDA ]]> https://biospectrumindia.com/news/95/12121/clomipramine-hcl-capsules-by-lupin-approved-by-fda-.html https://biospectrumindia.com/news/95/12121/clomipramine-hcl-capsules-by-lupin-approved-by-fda-.html Tue, 27 Nov 2018 11:05:00 +0530 Pharma company, Lupin has announced that it has received approval for its Clomipramine Hydrochloride Capsules USP, 25 mg, 50 mg, and 75 mg from the United States Food and Drug Administration (FDA) to market a generic version of SpecGx LLC’s Anafranil Capsules, 25 mg, 50 mg, and 75 mg. Lupin’s Clomipramine Hydrochloride Capsules USP, 25 mg, 50 mg, and 75 mg is the generic version of SpecGx LLC’s Anafranil Capsules, 25 mg, 50 mg, and 75 mg. It is indicated for the treatment of obsessions and compulsions in patients with Obsessive-Compulsive Disorder (OCD). Anafranil Capsules, 25 mg, 50 mg, and 75 mg had annual sales of approximately USD 109.6 million in the US (IQVIA MAT September 2018).   ]]> <![CDATA[Alembic Pharma gets USFDA nod for Xylocaine pain relief ointment ]]> https://biospectrumindia.com/news/95/12115/alembic-pharma-gets-usfda-nod-for-xylocaine-pain-relief-ointment-.html https://biospectrumindia.com/news/95/12115/alembic-pharma-gets-usfda-nod-for-xylocaine-pain-relief-ointment-.html Mon, 26 Nov 2018 22:10:00 +0530 Alembic Pharmaceuticals Limited has announced that its joint venture Aleor Dermaceuticals Limited has received approval from the US Food & Drug Administration (USFDA) for its Abbreviated New Drug Application (ANDA) Lidocaine Ointment USP, 5%. The approved ANDA is therapeutically equivalent to the reference listed drug product (RLD), Xylocaine Ointment, 5%, of AstraZeneca Pharmaceuticals LP (AstraZeneca). Lidocaine Ointment USP, 5% are indicated for production of anesthesia of accessible mucous membranes of the oropharynx. It is also useful as an anesthetic lubricant for intubation and for the temporary relief of pain associated with minor burns, including sunburn, abrasions of the skin and insect bites. Lidocaine Ointment USP, 5%, has an estimated market size of $ 97 million for twelve months ending December 2017 according to IQVIA. Alembic has a cumulative total of 79 ANDA approvals (66 final approvals and 13 tentative approvals) from US FDA, including this first ANDA approval for Aleor. ]]> <![CDATA[Rohto Pharma launches cooling eye drops in India ]]> https://biospectrumindia.com/news/95/12114/rohto-pharma-launches-cooling-eye-drops-in-india-.html https://biospectrumindia.com/news/95/12114/rohto-pharma-launches-cooling-eye-drops-in-india-.html Mon, 26 Nov 2018 22:00:00 +0530 The red, irritated eye because of pollution, the itchy eye after a mid-day hike; even the dry eye because of screen time. All of these can make the warm weather months a less than eye-opening experience. ROHTO has launched cooling eye drops that has the right formula to tackle any of these problems and keep eyes looking and feeling good all day long. Packed sterile in a small, attractive clear bottle, ROHTO Cooling Eye Drops are easy to pack in any bag. Perfect to take along to dusty road travels, backyard BBQ’s, and days spent at the pool or beach. Currently ROHTO Pharma (India) has launched below variants of Cooling Eye Drops: Icy Fresh Eye drops for Dry and Tired Eyes - its unique cooling formula delivers relief in a clear and non-blurring drop, so you can get right back to the things you love. No need to wait for the blur to go away, a common problem with other lubricant eye drops. It brings fast-acting, long-lasting relief for dry, irritated eyes due to overuse of digital devices, extended use of contact lenses, hormonal changes, or dry indoor or outdoor environments. Icy Clear Eye Drops for Red and Tired Eyes, which reduces redness and delivers an intense freshness that brings instant cooling comfort to irritated eyes due to late nights, eye strain, environmental conditions, pollen, dust and inadequate tear production. ROHTO endeavors to make the eyes healthier all around the world. On the Launch of ROHTO Cooling Eye Drops, Rohto Pharma (India) Managing Director, Mr. Koji Suzuki said, “Eye has been overused in today’s modern life exposed by UV ray outside, blue light of screen and atmospheric dust and pollution. Over a hundred years, ROHTO has been a symbol of eye care in the World. Just like dental care, ROHTO brought the daily care on the eyes via eye drops to protect the vision for long years. Feeling is Believing! ROHTO Cooling Eye Drops are available at our on-line partner, ‘SastaSundar.com’.where genuine drugs are always available with quick delivery." ]]> <![CDATA[Lupin launches India's first chatbot for patients ]]> https://biospectrumindia.com/news/95/12106/lupin-launches-indias-first-chatbot-for-patients-.html https://biospectrumindia.com/news/95/12106/lupin-launches-indias-first-chatbot-for-patients-.html Mon, 26 Nov 2018 10:10:00 +0530 Pharma major Lupin announced the launch of a chatbot named ‘ANYA’ specially designed to provide medically verified information for health-related queries. ANYA is the first bot of its kind to be launched in India for disease awareness. It’s a made in India for India initiative aimed at answering patient queries related to ailments. Launched at the 46th Annual Meeting of the Research Society for the Study of Diabetes, ANYA is an intelligent and patient-friendly chatbot trained to help patients with health-related concerns as part of their disease-management. As a start to digitize the patient journey in the overall healthcare space, Lupin is starting with ANYA to address queries related to diabetes. Recent research suggests that India is estimated to have had 72 million cases of diabetes in 2017 and the figure is expected to almost double to 134 million by 2025. Patients today are technologically advanced and like to be well informed on managing their health conditions. However, there is a lack of trusted and comprehensive sources on disease-management information for patients. The idea behind launching ANYA is to bridge this gap by providing medically verified information and acting as a preferred partner for doctors in resolving patient queries anytime. “At Lupin, we continue to explore ways to integrate technology to support effective patient care. Chatbot as a technology has enormous potential to aid in medical assistance and to support in building awareness and breaking myths associated with various therapies. We are taking the first step to offer this AI-based chatbot for patients and health-givers and we believe this will be a game changer in the field of disease management in the future. This will also be a significant step in providing better access in rural markets as we adopt and launch digital healthcare platforms for better outreach.” said Rajeev Sibal, President - IRF, Lupin. ANYA in Sanskrit means inexhaustible or limitless and this is the prime quality of the bot. As it evolves, ANYA will address all queries of patients and ensure their health conversations continue. ANYA is essentially a disease-management partner who aims to facilitate users in partnering with doctors in their journey to manage ailments. The main idea is to create a platform where patients can get easy and ready access to medically verified information, for their queries at any given time. ANYA will not replace Doctor’s diagnosis but rather act as a trusted information provider. ]]> <![CDATA[Dr. Reddy's Labs announces favorable outcome in patent litigation]]> https://biospectrumindia.com/news/95/12091/dr-reddys-labs-announces-favorable-outcome-in-patent-litigation.html https://biospectrumindia.com/news/95/12091/dr-reddys-labs-announces-favorable-outcome-in-patent-litigation.html Thu, 22 Nov 2018 16:00:00 +0530 Dr. Reddy's Laboratories Ltd. along with its subsidiaries together referred to as Dr. Reddy’s has announced that the United States Court of Appeals for the Federal Circuit issued a decision in favor of Dr. Reddy’s Laboratories Inc. concluding that Indivior had not shown that it is likely to succeed on the merits of its infringement case on U.S. Patent No. 9,931,305. This decision vacates the District Court’s preliminary injunction that had prohibited Dr. Reddy’s from selling its generic version of Suboxone (buprenorphine and naloxone) sublingual film. As a result of this ruling, Dr. Reddy’s will resume its launch activities as soon as permitted. A company spokesperson stated, “We are pleased with the decision of the appellate court in Dr. Reddy’s favor, vacating the preliminary injunction that had prevented Dr. Reddy’s from bringing this important drug to the public. We are committed to providing affordable and innovative medicines that address the unmet and under-met needs of patients around the world and in particular look forward to taking the lead in helping to fight Opioid Use Disorder.” In June, the U.S. Food and Drug Administration (USFDA) approved Dr. Reddy’s Buprenorphine and Naloxone Sublingual Film, in four strengths including 2 mg/0.5 mg, 4 mg/1 mg, 8 mg/2 mg, and 12 mg/3 mg, for sale in the U.S. market. The product was launched immediately after approval, with sales and commercialization activities halted as a result of a court-imposed temporary restraining order (TRO) against Dr. Reddy’s. The TRO did not include a prohibition on commercial manufacturing of the product. ]]> <![CDATA[USFDA approves Glenmark’s pneumonia treatment drug]]> https://biospectrumindia.com/news/95/12089/usfda-approves-glenmarks-pneumonia-treatment-drug.html https://biospectrumindia.com/news/95/12089/usfda-approves-glenmarks-pneumonia-treatment-drug.html Thu, 22 Nov 2018 15:40:00 +0530 Glenmark Pharmaceuticals said it has received final approval from the US health regulator for Atovaquone, used for prevention and treatment of a type pneumonia. Glenmark Pharmaceuticals Inc., USA has been granted final approval by the United States Food and Drug Administration (USFDA) for Atovaquone Oral Suspension USP in the strength of 750 mg/5 mL. The approved drug is a generic version of GlaxoSmithKline's Mepron Oral Suspension of similar strength. Quoting IQVIA sales data, Glenmark said, Mepron Oral Suspension market achieved annual sales of approximately USD 119.1 million. The company's current portfolio consists of 144 products authorised for distribution in the US marketplace and 55 abbreviated new drug applications (ANDAs) pending approval with the USFDA. ]]> <![CDATA[Kuehne + Nagel acquires Quick Group ]]> https://biospectrumindia.com/news/95/12086/kuehne-nagel-acquires-quick-group-.html https://biospectrumindia.com/news/95/12086/kuehne-nagel-acquires-quick-group-.html Thu, 22 Nov 2018 13:20:00 +0530 The Quick Group has entered into an agreement to be acquired by Kuehne + Nagel, one of the world's leading logistics companies in the airfreight, seafreight, contract logistics, and overland businesses. Quick will continue to offer tailor-made solutions to all the industries they serve and will operate as independent specialized product brands: Sterling Aviation, QuickSTAT, Quick Healthcare, and Quick Logistics. The Quick/Sterling team, including management, will continue to support their client base. Unitrans International Logistics will not be part of this transaction. The partnership will offer Quick's customers additional service and resource capabilities, with an expanded global footprint within Kuehne + Nagel's operating network across more than 100 countries. "We are very excited to become part of the Kuehne + Nagel Group and further expand the services we provide to our customers, with a clear focus on providing integrated logistics solutions with speed, control, communication, and IT efficiencies. We plan to continue leading the industry, providing the very best specialized solutions," says Dominique Bischoff-Brown, CEO, The Quick Group of Companies. The closing of the transaction is subject to the satisfaction of customary conditions. ]]> <![CDATA[Lupin launches generic Tetrabenazine Tablets ]]> https://biospectrumindia.com/news/95/12079/lupin-launches-generic-tetrabenazine-tablets-.html https://biospectrumindia.com/news/95/12079/lupin-launches-generic-tetrabenazine-tablets-.html Wed, 21 Nov 2018 15:30:00 +0530 Pharma major Lupin has announced the launch of Tetrabenazine Tablets, 12.5 mg and 25 mg having received an approval from the United States Food and Drug Administration (FDA) earlier. Lupin’s Tetrabenazine Tablets, 12.5 mg and 25 mg are the generic equivalent of Valeant Pharmaceuticals North America, LLC’s Xenazine® tablets. It is indicated for the treatment of chorea associated with Huntington’s disease. Xenazine® tablets had annual sales of $153 million in the US (IQVIA MAT September 2018). For the financial year ended 31st March, 2018, Lupin's Consolidated sales and Net profits before exceptional items were at Rs. 155,598 million (USD 2.41 billion) and Rs. 13,934 million (USD 216 million) respectively. ]]> <![CDATA[Piramal Pharma Solutions unveils new suite at Chennai API site]]> https://biospectrumindia.com/news/95/12076/piramal-pharma-solutions-unveils-new-suite-at-chennai-api-site.html https://biospectrumindia.com/news/95/12076/piramal-pharma-solutions-unveils-new-suite-at-chennai-api-site.html Wed, 21 Nov 2018 10:45:00 +0530 Piramal Pharma Solutions (PPS), a leading Contract Development and Manufacturing Organization (CDMO), announced the completion of its new cGMP kilo lab suite at its API (Active Pharmaceutical Ingredient) site in Ennore, Chennai, India. The suite will formally open on December 1, 2018. Ennore is a key API site in the PPS integrated site network, with capabilities from early development through commercial manufacturing, with an available capacity of over 300kL. The site supplies Key Starting Materials, Registered Starting Materials, Advanced Intermediates and APIs for both large pharma and biotech firms, in North America, Europe, and RoW markets. Anchored by a world-class R&D center, the cGMP kilo lab facility at Ennore will bridge the gap between Discovery and early Clinical development, addressing the needs of several discovery customers that want to rapidly advance their programs into the clinic. The facility operates in an ISO-8 certified clean room environment, with single fluid utility systems, supports temperatures ranging from -90°C to 200°C, and can handle batch sizes of up to 15 kg. Subsequent development and manufacturing of APIs as the programs advance can be carried out at the Piramal sites in Riverview (USA), Aurora (Canada), Digwal (India), in addition to Ennore. Vivek Sharma, Chief Executive Officer, Piramal Pharma Solutions, said, "Ennore continues to grow in terms of customer interest. Recently, we have seen an increase in demand for stand-alone early cGMP development projects, further augmented by requests from our discovery customers, to support early clinical development API supply from India. By adding this new cGMP kilo lab, we can now supply Phase I clinical requirements through several Piramal sites: Ennore, Riverview, and Aurora. With this kilo lab addition, we continue to offer choices to our partners, as they seek to advance projects from 'Concept to Commercial', all within the Piramal network." ]]> <![CDATA[Zydus Cadila gets USFDA nod to market generic Deferasirox tablets]]> https://biospectrumindia.com/news/95/12071/zydus-cadila-gets-usfda-nod-to-market-generic-deferasirox-tablets.html https://biospectrumindia.com/news/95/12071/zydus-cadila-gets-usfda-nod-to-market-generic-deferasirox-tablets.html Tue, 20 Nov 2018 15:45:00 +0530 Drug firm Zydus Cadila Tuesday said it has received a tentative nod from the US health regulator to market generic Deferasirox tablets used to treat high iron levels in the body. The company has received tentative approval from the United States Food and Drug Administration (USFDA) to market Deferasirox tablets in the strengths of 90 mg, 180 mg, and 360 mg.  The product will be manufactured at the group's formulations manufacturing facility at special economic zone (SEZ) in Ahmedabad.  The tablets are used to treat ongoing high levels of iron in the body caused by multiple blood transfusions. It is also used to treat high levels of iron in people with a certain blood disorder who do not require blood transfusions (non-transfusion dependent thalassemia).  The group has now 231 approvals and has so far filed over 340 abbreviated new drug applications (ANDAs) since the commencement of its filing process.  ]]> <![CDATA[Pharma Franchise, PCD Pharma biz to reach $250B by 2020: PharmaHopers ]]> https://biospectrumindia.com/news/95/12070/pharma-franchise-pcd-pharma-biz-to-reach-250b-by-2020-pharmahopers-.html https://biospectrumindia.com/news/95/12070/pharma-franchise-pcd-pharma-biz-to-reach-250b-by-2020-pharmahopers-.html Tue, 20 Nov 2018 15:20:00 +0530 Pharma Franchise & PCD Pharma has emerged as a potential business sector in the Pharmaceutical Industry. Indian Pharmaceutical Industry is growing with the CAGR of 15% and is expected to touch USD 250 billion by 2020. Investing in Pharma Franchise is considered profitable by pharma experts. With the increasing scope of Pharma Franchise & PCD Pharma in India, it is not wrong to say that PCD Pharma Franchise is the backbone of Pharmaceutical companies. The trajectory of Indian Pharmaceutical is strong from past few years due to: The rise in disposable income Increase in the number of Aging Population Rising Literacy Level Improvement in Medical Infrastructure High fragmentation with the low prices of drugs, low production costs, skills, knowledge, and quality makes the future of PCD Pharma Franchise business bright in the domestic market. If pharma scholars to believed, India's pharmaceutical industry is expected to expand at a CAGR of 22.4 per cent over 2015-20 to reach US$ 55 billion. 180 New Units are coming up in Gujarat with an Investment of around Rs 7,000 Crore  Alone in Gujarat, the pharma industry is booming; "Pharma companies have applied for registration of around 180 new units are to be set up in Gujarat, which is a significant happening. This registration has happened during the past one year. Earlier, we had received around 70 applications annually," said State Foods and Drugs Control Authority (FDCA) Commissioner Hemant Koshiya. Although this is also due to the expiry of incentives given by the hilly regional states like the north-eastern states and Himachal Pradesh, for which one cannot deny the growth of the pharma sector in India. These are just the figures about Gujarat, there are many other states as well which have pharma industry and great scope for Pharma Franchise business. Pharmaceutical Franchise  Franchise generally helps in escaping the 'corporate world' and makes one an entrepreneur. PCD Pharma Franchise business initially may keep investors on their toes but the rewards, both emotionally and financially, are immeasurable. By being a part of the Pharma Franchise Company, one can achieve good supply of stocks, high advertisement in the market and low-priced products, catering the requirements of a great work experience and helps the individual to earn well.   PCD (propaganda Cum Distribution) and Pharma Franchise both work in the same process where a pharma individual gets the marketing and distribution right from a pharma company and the company provides products, brand name, and support to its franchise partner. ]]> <![CDATA[Glenmark gets USFDA nod for generic acne treatment gel ]]> https://biospectrumindia.com/news/95/12067/glenmark-gets-usfda-nod-for-generic-acne-treatment-gel-.html https://biospectrumindia.com/news/95/12067/glenmark-gets-usfda-nod-for-generic-acne-treatment-gel-.html Tue, 20 Nov 2018 13:15:00 +0530 Glenmark Pharmaceuticals has said that it has received approval from the US health regulator for Azelaic Acid gel used in treatment of acne. The approval granted to Glenmark Pharmaceuticals Inc by the US Food and Drug Administration (USFDA) is for Azelaic Acid Gel, 15 per cent, which is a generic version of Finacea Gel (15 per cent) of Leo Pharma, the company said in a statement. Glenmark Pharmaceuticals has said that it has received approval from the US health regulator for Azelaic Acid gel used in treatment of acne. The approval granted to Glenmark Pharmaceuticals Inc by by the US Food and Drug Administration (USFDA) is for Azelaic Acid Gel, 15 per cent, which is a generic version of Finacea Gel (15 per cent) of Leo Pharma, the company said in a statement. According to the news reported by PTI, citing market data, the company said for the 12-month period ended September 2018, Finacea Gel (15 per cent ) achieved annual sales of approximately USD 64.1 million. Glenmark has a portfolio comprising 143 products authorised for distribution in the US market and 56 ANDAs pending approval with the USFDA. ]]> <![CDATA[AstraZeneca India & Business Sweden launch ‘Unnati Healthcare 2.0 – Innovation Challenge]]> https://biospectrumindia.com/news/95/12059/astrazeneca-india-business-sweden-launch-unnati-healthcare-2-0-innovation-challenge.html https://biospectrumindia.com/news/95/12059/astrazeneca-india-business-sweden-launch-unnati-healthcare-2-0-innovation-challenge.html Mon, 19 Nov 2018 17:55:00 +0530 AstraZeneca Pharma India Limited, a leading global science-led biopharmaceutical organisation & Business Sweden - The Swedish Trade and Invest Council has announced the launch of ‘Unnati Healthcare 2.0- An Innovation Challenge. This challenge, which has been launched for the first time, aims to encourage innovative solutions that can positively impact the treatment paradigm of Non-Communicable Diseases (NCDs) in India. Recent years have seen an alarming shift from communicable diseases (CDs) to Non-Communicable Diseases (NCDs) in the Indian Healthcare system. Technology and competence to cater to these NCD’s are largely concentrated in hospitals, as well as the increased cost-factor makes it difficult to cater to everyone’s requirements, when it comes to early screening and disease management. Over 2.7 million cases of cardiovascular diseases, 62 million of diabetes, 1.5 million of stroke, 30 million chronic respiratory diseases and 1 million of cancer has further strengthened India’s commitment of working towards reduction of premature deaths due to NCDs through varied prevention measures and treatments.[i] The need of the hour is to come up with diverse expertise that can provide solutions like: Remote/Portable screening methods for early detection of NCDs Precise, handy point of care diagnostic solutions that will ease detection and monitoring Digital tools/techniques that enable efficient health record capture, patient monitoring, treatment pathway solutions and adherence trackers Unnati Healthcare 2.0 is an initiative to celebrate the spirit of Indo-Swedish Innovation partnership and providing proficiency towards disease management, reducing healthcare costs and saving lives. The registration process for this challenge is open until 10thDecember, 2018 and is especially suitable for companies, entrepreneurs and people working in healthcare areas including diabetes, cardiovascular diseases, cancer/ oncology or respiratory. Speaking on the rationale behind this challenge, Gagan Singh Bedi, Managing Director, AstraZeneca Pharma India Limited said, “There is a requirement to establish an incubation of providers with diverse expertise who can bring relevant, meaningful innovative solutions that can foster holistic management of non-communicable diseases. We are pleased to partner with Business Sweden, Atal Innovation Mission – NITI Aayog, AGNIi and other reputed industry partners for this challenge and hope to receive positive response from stakeholders across the ecosystem, who are working hard to impact patients’ lives.” Carsten Grönblad, Swedish Trade Commissioner to India said, “UNNATI is a model for co-innovation allowing industry, startups and the civil society to jointly develop solutions addressing global social needs. This challenge calls for collaboration to implement early- and remote screening as well as efficient, AI-based patient management. This is an important task as we see the prevalence of non-communicable diseases rise globally. We are happy to partner with AstraZeneca India, AGNIi and Atal Innovation Mission – NITI Aayog, with a shared vision of providing affordable and accessible healthcare.” Selected participants will be invited to present their ideas at the Indo-Sweden workshop scheduled in the first quarter of 2019 in New Delhi. Winners of the challenge will receive expert support from AstraZeneca India and funding by the Swedish innovation fund allocated to India, in order to further develop their ideas.   ]]> <![CDATA[Aurobindo Pharma to launch products in US by 2021]]> https://biospectrumindia.com/news/95/12053/aurobindo-pharma-to-launch-products-in-us-by-2021.html https://biospectrumindia.com/news/95/12053/aurobindo-pharma-to-launch-products-in-us-by-2021.html Mon, 19 Nov 2018 12:25:00 +0530 Aurobindo Pharma is looking to launch first set of oncology, respiratory, complex injectables and topical products in the US in the next three years as part of plans to build a robust specialty products portfolio. The company is also planning to launch first set of biosimilars and vaccines in growth markets during this time, Aurobindo Pharma said in an investor presentation. The growth markets for the company include Gulf Cooperation Council (GCC) countries, Ukraine, South Africa, East Africa, Myanmar, Canada, Mexico, Colombia and Brazil. Sharing the medium-term road map (from 2019-2021), the company said it will focus on launching "first set of oncology, respiratory, complex injectables, topical products and ADF products in the US." The company is also focussing on securing intellectual property (IP) and ramping up and filing of specialty products, it said, reported PTI. For the long term, from 2022 onwards, Aurobind Pharma plans "launch of inhalers, transdermals, biosimilars, and branded (both Rx and OTC) products in advanced markets," the presentation said. The company is also looking to work on biologic licence applications (BLAs), it added. ]]> <![CDATA[Zydus Cadilla gets USFDA nod to market generic HIV treatment tablets]]> https://biospectrumindia.com/news/95/12043/zydus-cadilla-gets-usfda-nod-to-market-generic-hiv-treatment-tablets.html https://biospectrumindia.com/news/95/12043/zydus-cadilla-gets-usfda-nod-to-market-generic-hiv-treatment-tablets.html Fri, 16 Nov 2018 15:15:00 +0530 Drug firm Zydus Cadila has said that it has received final approval from the US health regulator to market generic Abacavir and Lamivudine tablets used for treatment of a type of HIV infection. The company also said in the regulatory filing that it had received final approval from the United States Food and Drug Administration (USFDA) to market generic Fondaparinux Sodium injection. The approval from the USFDA is for Abacavir and Lamivudine tablets USP in the strength of 600 mg/300 mg, Zydus Cadila said. The tablets are used with other antiretroviral medicines to treat human immunodeficiency virus-type 1 (HIV-1) infection that causes acquired immune deficiency syndrome (AIDS), it added. "The product will be manufactured at the group's formulations manufacturing facility at special economic zone (SEZ), Ahmedabad," Zydus Cadila said. The nod for the Fondaparinux Sodium injection USP is in the strengths of 2.5 mg/0.5 mL, 5 mg/0.4 mL, 7.5 mg/0.6 mL and 10 mg/0.8 mL single-dose, it added. Fondaparinux Injection is used to treat blood clots in deep veins and the lungs. It can also be used to prevent blood clots in patients undergoing certain types of surgeries, Zydus Cadila said. "It will be manufactured at a partner's manufacturing site," it added. Zydus Cadila said that the group now has more than 230 approvals and has so far filed over 330 abbreviated new drug applications (ANDAs) since the commencement of its filing process, reported PTI. ]]> <![CDATA[Lupin receives FDA nod for blood cells disorder drug]]> https://biospectrumindia.com/news/95/12034/lupin-receives-fda-nod-for-blood-cells-disorder-drug.html https://biospectrumindia.com/news/95/12034/lupin-receives-fda-nod-for-blood-cells-disorder-drug.html Thu, 15 Nov 2018 16:55:00 +0530 Pharma major Lupin announced that it has received approval for its Decitabine for Injection, 50 mg/vial, Single-Dose Vial from the United States Food and Drug Administration (FDA) to market a generic version of Otsuka Pharmaceutical Co. Ltd.’s (Otsuka) Dacogen for Injection, 50 mg/vial, Single-Dose Vial. Lupin’s Decitabine for Injection, 50 mg/vial, Single-Dose Vial is the generic version of Otsuka’s Dacogen for Injection, 50 mg/vial, Single-Dose Vial. It is indicated for the treatment of patients with myelodysplastic syndromes (MDS) including previously treated and untreated, de novo and secondary MDS of all French-American-British subtypes (refractory anemia, refractory anemia with ringed sideroblasts, refractory anemia with excess blasts, refractory anemia with excess blasts in transformation, and chronic myelomonocytic leukemia) and intermediate-1, intermediate-2, and high-risk International Prognostic Scoring System groups. Decitabine for Injection, 50 mg/vial, Single-Dose Vial had annual sales of approximately USD 135.9 million in the US (IQVIA MAT September 2018). ]]> <![CDATA[India’s Translumina Becomes First Company in the world to present 10-year safety data of drug eluting stents]]> https://biospectrumindia.com/news/95/12030/indias-translumina-becomes-first-company-in-the-world-to-present-10-year-safety-data-of-drug-eluting-stents.html https://biospectrumindia.com/news/95/12030/indias-translumina-becomes-first-company-in-the-world-to-present-10-year-safety-data-of-drug-eluting-stents.html Thu, 15 Nov 2018 12:25:00 +0530 Proving to be a major boost for the Indian medical device manufacturing industry, which is majorly dominated by US multinationals, a leading Indian producer Translumina Therapeutics LLP achieves a special feat of becoming the first company in the world to demonstrate a 10-year patient safety and efficacy data of its drug eluting stent (DES) Yukon Choice PC. This is for the first time that a decade long research data has been presented for the efficacy and safety of DES since its launch in 2001, as no other research has published data of more than 5 years. The research findings of a randomized control trial called ISAR-TEST 4 were presented by leading cardiac expert from Germany, Dr. Sebastian Kufner at the prestigious 2018 American Heart Association Scientific Sessions at Chicago, Illinois, United States, today in the presence of leading cardiologists from all over the world. “It was a privilege for me to present the first long-term data of Yukon Choice PC DES of 10 years efficacy and safety. This will not only prove the efficacy and safety of DES for long term, but also gives boost for the long-term success of the procedure of angioplasty after the launch of DES”, said Dr Sebastian Kufner, Associate Professor of Cardiology, German Heart Centre, Munich, Germany. The data demonstrated that at 10 years, both Indian made ‘Yukon Choice PC’ and much used USFDA approved ‘Xience’ stents showed significantly better results than the Cypher stent regarding major adverse cardiac events, with a risk reduction of 18% and 21% and mortality risk reduction of 18% and 22%, respectively. There were no significant differences between Yukon Choice PC and Xience stents regarding these outcomes. However, Yukon Choice PC showed the lowest rate of definite or probable stent thrombosis with a significant risk reduction than the ‘Cypher’ stent (50% reduction) and even a numerically lower rate as than the ‘Xience’ stent (29% reduction). The significance of this data has been further acknowledged by one of the most respected journals of cardiology, ‘Circulation’ that published it in its exclusive ahead-of-print online edition simultaneously. Mr. Gurmit Singh Chugh, Managing Director, Translumina Therapeutics, who was present during the data presentation, was very excited with results and its presentation at this prestigious forum. He stated “We are excited with this first long term data which is a new milestone and a benchmark for efficacy and safety of DES Worldwide. Yukon Choice PC showing the lowest Stent thrombosis rates compared to Xience and Cypher at 10 years creates a strong testimony that this technology is truly next generation in terms of safety. Prof Adnan Kastrati, Principal Investigator of ISAR Test 4 and the Director of Cardiac Cath Lab at German Heart Centre, Munich stated “The 10-year results achieved in this trial with new-generation DES provide a strong argument against still existing concerns about the long-term safety of DES”. He elaborated that Yukon Choice PC uses a unique technology consisting in the combination of special surface modification and low polymeric load for controlled and optimal release kinetics of an anti-proliferative drug. The excellent results are a confirmation of the great and durable performance of this device. Yukon Choice PC stents are manufactured at the Dehradun facility of Translumina Therapeutics, which holds around 15 per cent share of the Rs 1,500 crore stents market in India.  The trial ISAR-TEST 4 compared Yukon Choice PC against Xience (manufactured by Abbott Vascular, USA) in 2603 patients in Germany for a follow-up period of 10 years. It is interesting to note that National Pharmaceutical Pricing Authority (NPPA) had put an upper ceiling of MRP in Feb 2017 by slashing the MRP of DES by over 70%. This move proved to be extremely beneficial for domestic manufacturers to make their high end technologies available to the hospitals at a time when multinational players were withdrawing their DES citing unaffordability. Translumina Therapeutics emerged a stronger player post price ceiling as it offered high quality and proven DES at the ceiling prices. “I wish to dedicate this success to our Prime Minister Shri Narendra Modi who created a belief about the possibility of manufacturing high-end medical devices in India. He has provided an encouraging and conducive ecosystem for the manufacturing of complex technologies in India,” said Punita Sharma, Co-Founder, Translumina Therapeutics. The DES market in the World was dominated by US multinationals for more than 15 years since the launch of DES. Most of the pivotal randomized trials of DES had a maximum follow-up for up to 5 years. With more young patients getting CAD, cardiologists from all over the world were anxious to get some insights on the long-term performance of the new generation DES in terms of efficacy and safety. “The long-term data from the ISAR-TEST 4 trial shall not only increase the confidence of Cardiologists on these new generation DES but shall also reassure patients who have received these DES for the treatment of coronary artery disease. I am pleased that one of these technologies is coming from India which shall create immense positivity and high acceptance for Indian manufactured DES world over” said Dr. Robert Byrne, Deputy Director of Cardiology at German Heart Center and Senior Author of the presented study. ]]> <![CDATA[Aurobindo Pharma to acquire Australian firm's product]]> https://biospectrumindia.com/news/95/12018/aurobindo-pharma-to-acquire-australian-firms-product.html https://biospectrumindia.com/news/95/12018/aurobindo-pharma-to-acquire-australian-firms-product.html Wed, 14 Nov 2018 12:55:00 +0530 Aurobindo Pharma has said it's wholly-owned subsidiary has entered into an agreement to acquire a product under development and related assets from Australia-based Advent Pharmaceuticals Pty Ltd for $12.5 million. "Our wholly-owned subsidiary, Aurobindo Pharma USA Inc., USA, has entered into an agreement to acquire a product under development and related assets from Advent Pharmaceuticals Pty Ltd, Australia, through AuroScience Pty Limited, Melbourne, a 100 per cent subsidiary of Aurobindo Pharma USA Inc, USA," a regulatory filing from Aurobindo said Monday. Based out of Melbourne, Advent Pharmaceuticals is engaged in developing and commercialising generic inhaled medicines for global markets. ]]> <![CDATA[Suven secures product patents in Australia, Hong Kong]]> https://biospectrumindia.com/news/95/12016/suven-secures-product-patents-in-australia-hong-kong.html https://biospectrumindia.com/news/95/12016/suven-secures-product-patents-in-australia-hong-kong.html Wed, 14 Nov 2018 11:15:00 +0530 Suven Life Sciences Ltd (Suven) recently announced that the grant of one product patent from Australia (2016276139) and one product patent from Hong Kong (HK1217483) corresponding to the New Chemical Entities for the treatment of disorders associated with Neurodegenerative diseases and patents are valid through 2036 and 2033 respectively. The granted claims of the patents include the class of selective M1 PAM and 5-HT4 compounds respectively and are being developed as therapeutic agents for neurodegenerative disorders such as for the treatment of cognitive impairment associated with neurodegenerative disorders like Alzheimer’s disease, Attention deficient hyperactivity disorder (ADHD), Huntington’s disease, Parkinson and Schizophrenia etc. “We are very pleased by the grant of these patents to Suven for our pipeline of molecules in CNS arena that are being developed for cognitive disorders with high unmet medical need with huge market potential globally” says Venkat Jasti, CEO of Suven. ]]> <![CDATA[Lupin launches generic solution of pneumonia in US]]> https://biospectrumindia.com/news/95/12007/lupin-launches-generic-solution-of-pneumonia-in-us.html https://biospectrumindia.com/news/95/12007/lupin-launches-generic-solution-of-pneumonia-in-us.html Tue, 13 Nov 2018 10:10:00 +0530 Pharma major Lupin has announced the launch of Atovaquone Oral Suspension USP, 750 mg/5 mL having received an approval from the United States Food and Drug Administration (FDA) earlier. Lupin’s Atovaquone Oral Suspension USP, 750 mg/5 mL is the generic equivalent of Glaxosmithkline LLC’s Mepron® oral suspension 750 mg/5 mL. It is indicated for the prevention of Pneumocystis jirovecii pneuomonia (PCP) in adults and adolescents aged 13 years and older who cannot tolerate trimethoprimsulfamethoxazole (TMP-SMX). It is also for the treatment of mild-to-moderate PCP in adults and adolescents aged 13 years and older who cannot tolerate TMP-SMX. Atovaquone Oral Suspension USP, 750 mg/5 mL had annual sales of approximately $119 million in the US (IQVIA MAT September 2018). ]]> <![CDATA[InvaGen announces acquisition agreement with Avenue Therapeutics]]> https://biospectrumindia.com/news/95/12006/invagen-announces-acquisition-agreement-with-avenue-therapeutics.html https://biospectrumindia.com/news/95/12006/invagen-announces-acquisition-agreement-with-avenue-therapeutics.html Tue, 13 Nov 2018 09:55:00 +0530 InvaGen Pharmaceuticals Inc., a subsidiary of the leading global pharmaceutical company Cipla Limited, has announced that it has entered into definitive agreements with two closing stages for a proposed acquisition of Avenue Therapeutics, Inc., a Fortress Biotech company focused on the development and commercialization of intravenous (IV) Tramadol. The transaction will be subject to Avenue stockholders’ and regulatory approvals, and other closing conditions. At the first stage closing, InvaGen or its affiliates will acquire, through the issuance by Avenue of new shares, shares representing a 33.3% stake in Avenue’s capital stock on a fully diluted basis for $35 million. Based on current assumptions, such stake is expected to consist of 5,833,333 shares of Avenue’s common stock issued at $6.00 per share. Simultaneously with the closing of the stock issuance, InvaGen or its affiliates will appoint three members (including one independent) on Avenue’s seven-member Board of Directors. At the second stage closing, InvaGen or its affiliates will acquire the remaining shares of Avenue’s common stock, pursuant to a reverse triangular merger with Avenue remaining as the surviving entity, for up to $180 million in the aggregate, which is currently expected to represent approximately $13.92 per share, subject to certain terms to be outlined in the Form 8-K and proxy statement to be filed by Avenue with the SEC in connection with the proposed transactions. The second stage closing is subject to the satisfaction of certain closing conditions, including conditions pertaining to US FDA approval, labeling, scheduling and the absence of any REMS or similar restrictions in effect with respect to IV Tramadol. Umang Vohra, Managing Director & Global Chief Executive Officer, Cipla, said  “Our investment in and proposed acquisition of Avenue establishes our presence in the specialty institutional business in the US. The novel intravenous drug delivery method of Tramadol addresses extremely crucial and hitherto unmet needs in pain management. This investment is in keeping with our stated intention to build a specialty pipeline in the US market, and reinforces Cipla’s innovation-led approach and commitment to caring for the life of patients.” Lucy Lu, M.D., President & Chief Executive Officer, Avenue, said “We are very pleased to partner with InvaGen to accelerate the Phase 3 clinical development and potential commercialization of IV Tramadol in the United States. IV Tramadol offers a novel mechanism of action among intravenous analgesics and could be an important new therapy that fills a significant gap in pain management. We believethat this transaction creates significant value for our shareholders and creates a path to maximize their return on investment.” Torreya Capital LLC is acting as exclusive financial advisor to Avenue. Oppenheimer & Co, Inc. provided a fairness opinion on the transaction to Avenue’s Board of Directors. Alston & Bird LLP and Richards, Layton & Finger, P.A. served as legal counsel to Avenue, and Hughes Hubbard & Reed LLP served as legal counsel to Cipla. ]]> <![CDATA[Cipla gets USFDA nod for pain relief gel of osteoarthritis]]> https://biospectrumindia.com/news/95/12000/cipla-gets-usfda-nod-for-pain-relief-gel-of-osteoarthritis.html https://biospectrumindia.com/news/95/12000/cipla-gets-usfda-nod-for-pain-relief-gel-of-osteoarthritis.html Mon, 12 Nov 2018 11:55:00 +0530 Drug major Cipla has received final approval from the United States Food and Drug Administration (USFDA) for Diclofenac Sodium Topical Gel, indicated for the relief of the pain of osteoarthritis of joints such as the knees and hands. Diclofenac Sodium Topical Gel, 1 per cent is a generic therapeutic equivalent to the reference listed drug (RLD), Voltaren Gel, 1 per cent of GlaxoSmithKline Consumer Health, Cipla in a BSE filing. Citing IQVIA data, the company said Voltaren Gel and its generic equivalents had US sales of approximately $353 million for the 12 month period ending June 2018. Cipla said the product will be available for shipping in the US in the upcoming week. ]]> <![CDATA[Biocon's Bengaluru plant completes USFDA inspection without any observations ]]> https://biospectrumindia.com/news/95/11999/biocons-bengaluru-plant-completes-usfda-inspection-without-any-observations-.html https://biospectrumindia.com/news/95/11999/biocons-bengaluru-plant-completes-usfda-inspection-without-any-observations-.html Mon, 12 Nov 2018 11:50:00 +0530 Biotechnology major Biocon said that the US health regulator has completed inspection of its new manufacturing facility in Bengaluru without any observations. "The United States Food and Drug Administration (USFDA) conducted a pre-approval inspection of our new oral solid dosage forms manufacturing facility at Biocon Park in Bengaluru from November 5-9, 2018," Biocon said in a regulatory filing. The audit concluded without any observations and no Form 483 was issued, reported PTI. A Form 483, is issued by the USFDA to notify a company's management of any objectionable conditions at its manufacturing facilities. It is issued to the management of a firm at the conclusion of an inspection. ]]> <![CDATA[Lupin gets EIR from USFDA for Nagpur facility]]> https://biospectrumindia.com/news/95/11998/lupin-gets-eir-from-usfda-for-nagpur-facility.html https://biospectrumindia.com/news/95/11998/lupin-gets-eir-from-usfda-for-nagpur-facility.html Mon, 12 Nov 2018 11:40:00 +0530 Pharma major Lupin has announced the receipt of the Establishment Inspection report (EIR) post the completion of a Pre-Approval Inspection (PAI) for its Phenytoin Sodium Extended Release 100 mg capsules, carried out by the US FDA at its Nagpur facility in Maharashtra. The inspection conducted in September 2018 concluded without any observations. Lupin’s Nagpur facility is the company’s latest site and manufactures Oral Solid Dosage products. The site also houses Lupin’s state of the art injectable manufacturing facility. Commenting on the development, Nilesh Gupta, Managing Director, Lupin said, “The receipt of the EIR for our Nagpur facility is a positive development as we continue our journey on meeting and exceeding global quality standards at all of our facilities.” ]]> <![CDATA[Strides enters into partnership with SUDA Pharma for migraine drug]]> https://biospectrumindia.com/news/95/11992/strides-enters-into-partnership-with-suda-pharma-for-migraine-drug.html https://biospectrumindia.com/news/95/11992/strides-enters-into-partnership-with-suda-pharma-for-migraine-drug.html Fri, 09 Nov 2018 18:35:00 +0530 Strides Pharma Science Limited (Strides)  has announced  that  its  step‐down  wholly  owned  subsidiary,  Strides  Pharma  Global  Pte Limited,  Singapore  has  entered  into  an  exclusive  product  development,  licensing  and supply agreement with SUDA Pharmaceuticals Ltd for its novel drug SUD‐001H, an oral spray of sumatriptan to treat migraine headache for the US market.  Sumatriptan is one of the most widely used drugs for the treatment of acute migraine in adults. SUD‐001H is a first‐in‐class mint‐flavoured oral spray formulation of sumatriptan (marketed in tablet form and in a nasal spray by GlaxoSmithKline under the brand name Imitrex). The product will be filed with the USFDA under the 505B (2) regulatory pathway and on approval is expected to be the first fast‐acting oral spray of sumatriptan in the US market.  The product will utilize SUDA’s recently developed proprietary OroMist hydrotrope technology that significantly improves the rate of absorption and the quantity of drug that is absorbed across the mucosal membranes. A primary market assessment on the potential for SUD‐001H for the treatment of adult migraine confirmed the need for a product that could demonstrate a faster onset of action and the same was supported by medical practitioners. SUDA is to receive an upfront cash payment of $0.4 million and a further payment of $ 0.6 million on reaching certain milestones including the pilot first‐in‐man clinical study, submission and approval of the product in the US. ]]> <![CDATA[AstraZeneca to sell rights of Alvesco, Omnaris, Zetonna]]> https://biospectrumindia.com/news/95/11986/astrazeneca-to-sell-rights-of-alvesco-omnaris-zetonna.html https://biospectrumindia.com/news/95/11986/astrazeneca-to-sell-rights-of-alvesco-omnaris-zetonna.html Wed, 07 Nov 2018 12:05:00 +0530 AstraZeneca has entered into an agreement with Covis Pharma B.V. (Covis Pharma) to sell its rights to the medicines Alvesco (ciclesonide), used for the treatment of persistent asthma, and Omnaris and Zetonna (ciclesonide), used for the treatment of nasal symptoms associated with rhinitis. The rights cover markets outside the US and the US royalties for the medicines. Covis Pharma currently commercialises Alvesco, Omnaris and Zetonna in the US and will become the owner of the medicines upon closing. The transaction does not include the transfer of any AstraZeneca employees or facilities. Alvesco is an inhaled anti-inflammatory maintenance therapy delivered by a metered-dose inhaler to help control persistent asthma. Omnaris and Zetonna are nasal sprays for the treatment of nasal symptoms associated with seasonal allergic and allergic/non-allergic perennial rhinitis. The active ingredient in all three medicines is ciclesonide, a synthetic corticosteroid that helps relieve inflammation. Covis Pharma will pay AstraZeneca $350 million upon closing, in addition to conditional sales-related payments of up to $21 million over four years from 2019. The agreement is subject to customary closing conditions and is expected to complete by the end of 2018. As AstraZeneca will not maintain a significant ongoing interest in the medicines following completion, the payments will be recognised as Other Operating Income in the Company’s financial statements. Combined 2017 Product Sales of Alvesco, Omnaris and Zetonna, recorded by AstraZeneca, were $106 million. The agreement does not affect the Company’s financial guidance for 2018. ]]> <![CDATA[Lilly, NextCure to develop novel immuno-onco medicines]]> https://biospectrumindia.com/news/95/11983/lilly-nextcure-to-develop-novel-immuno-onco-medicines.html https://biospectrumindia.com/news/95/11983/lilly-nextcure-to-develop-novel-immuno-onco-medicines.html Tue, 06 Nov 2018 12:50:00 +0530 Eli Lilly and Company and NextCure, Inc. have announced a multi-year collaboration focused on the discovery and development of immuno-oncology therapies. The collaboration seeks to discover novel cancer targets utilizing NextCure's proprietary FIND-IO platform. Under the terms of the agreement, Lilly and NextCure will each receive options to exclusively license antibodies resulting from the collaboration. NextCure will receive an upfront payment of $25 million, and will be eligible for development and commercial milestones and royalty payments, should Lilly successfully develop and commercialize new cancer therapies resulting from the collaboration. Additionally, Lilly has made a $15 million equity investment in NextCure. "The emerging field of immuno-oncology is offering new treatment options and hope to cancer patients," said Greg Plowman, M.D., Ph.D., vice president of oncology research at Lilly. "Through this collaboration, we hope to leverage NextCure's discovery platform to expand the reach of this class of groundbreaking treatments by identifying novel cancer targets that could enable the development of a new generation of immuno-oncology therapies." ]]> <![CDATA[FDA completes successful inspection of DCA Bavla site]]> https://biospectrumindia.com/news/95/11981/fda-completes-successful-inspection-of-dca-bavla-site.html https://biospectrumindia.com/news/95/11981/fda-completes-successful-inspection-of-dca-bavla-site.html Tue, 06 Nov 2018 12:05:00 +0530 India-based Dishman Carbogen Amcis Limited (DCA), a global outsourcing partner for the pharmaceutical industry, has announced that its manufacturing and development facility in Bavla, Gujarat has successfully completed an inspection by the U.S. Food and Drug Administration (FDA). The FDA’s Current Good Manufacturing Practices (CGMP) audit, which is performed to ensure proper design, monitoring and control of manufacturing processes and facilities, was held from October 22-26. The five-day inspection focused on the Active Pharmaceutical Ingredient (API) units and ancillary areas of the Bavla site, specifically the quality system, production and packaging operations. The inspection also included examinations of the warehouses and quality control areas. No critical observations were reported and the final Establishment Inspection Report (EIR) is expected within the next six months. “I am extremely pleased with the positive outcome of this FDA inspection. It is the result of our ongoing dedication to maintaining high quality standards and continuously meeting our customers’ expectations,” said J. R. Vyas, Chairman and Founder of the Dishman Carbogen Amcis Group. “It was especially rewarding for us to hear that the auditor appreciated our teams’ open communication and transparent way of working. I am very proud of our staff. Their commitment to excellence every day is the key to our performance and our long track record of successful audits,” said Dr. Himani Dhotre, CEO of the DCAL Bavla site. The Bavla facility manufactures products according to CGMP standards and is routinely inspected by legal authorities and external customers. The facility underwent successful FDA inspections in 2006, 2012, 2015 and 2016. ]]> <![CDATA[Lupin receives FDA approval for Doxercalciferol Injection]]> https://biospectrumindia.com/news/95/11976/lupin-receives-fda-approval-for-doxercalciferol-injection.html https://biospectrumindia.com/news/95/11976/lupin-receives-fda-approval-for-doxercalciferol-injection.html Mon, 05 Nov 2018 22:20:00 +0530 Pharma major Lupin has received approval for its Doxercalciferol Injection, 4 mcg/2 mL (2 mcg/mL) Multi-dose Vials from the United States Food and Drug Administration (FDA) to market a generic version of Sanofi Genzyme’s Hectorol Injection. Lupin’s Doxercalciferol Injection, 4 mcg/2 mL (2 mcg/mL) Multi-dose Vial is the generic version of Genzyme’s Hectorol Injection. It is indicated for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease on dialysis. Doxercalciferol Injection, 4 mcg/2 mL (2 mcg/mL) Multi-dose Vials had annual sales of approximately $ 133 million in the US. ]]> <![CDATA[Nephroplus acquires DaVita Care India]]> https://biospectrumindia.com/news/95/11975/nephroplus-acquires-davita-care-india.html https://biospectrumindia.com/news/95/11975/nephroplus-acquires-davita-care-india.html Mon, 05 Nov 2018 16:20:00 +0530 NephroPlus, India’s largest dialysis care network and a trailblazer in redefining dialysis care in India announced the acquisition of DaVita Care India, part of DaVita Inc., a Fortune 500® company, and a leading provider of kidney care in India today.  Under the terms of the agreement, which closed today, NephroPlus will acquire DaVita Care India’s network of 22 centers which serve more than 1,700 dialysis patients nationwide. With this acquisition, Nephroplus will further strengthen its servicing capacity as the dominant dialysis centre network and will have a presence in 18 states of India with 176 centers across 97 cities.   DaVita Care (India) Pvt. Ltd. owns and operates a network of dialysis and kidney care centers that provide care for acute and end-stage renal disease patients in India. The company offers dialysis services, including in-center and home hemodialysis, peritoneal dialysis, and AV Fistula and AV graft procedures and allied services that include psychological counseling and diet and nutrition advice.   ]]> <![CDATA[Lupin recalls 6,752 bottles of Testosterone Topical solution from U.S.]]> https://biospectrumindia.com/news/95/11971/lupin-recalls-6752-bottles-of-testosterone-topical-solution-from-u-s-.html https://biospectrumindia.com/news/95/11971/lupin-recalls-6752-bottles-of-testosterone-topical-solution-from-u-s-.html Mon, 05 Nov 2018 15:00:00 +0530 The US arm of drug firm Lupin is recalling 6,752 bottles of Testosterone Topical solution from the American market on account of defective container, the USFDA said. The product is indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone. Lupin Pharmaceuticals Inc is recalling the 6,752 bottles of Testosterone Topical solution in the strength of 30mg/1.5mL manufactured by Lupin at its Pithampur plant, the US health regulator said in an Enforcement Report. The reason for recall is "Defective Container: Repetitive complaints received indicating pump not working," it added. The voluntary ongoing nationwide recall is a class III recall, the report said. As per the United States Food and Drug Administration (USFDA), a class III recall is initiated in a situation,"in which use of or exposure to a violative product is not likely to cause adverse health consequences." ]]> <![CDATA[Aurobindo initiates to recall oncogenic hypertension drug ]]> https://biospectrumindia.com/news/95/11968/aurobindo-initiates-to-recall-oncogenic-hypertension-drug-.html https://biospectrumindia.com/news/95/11968/aurobindo-initiates-to-recall-oncogenic-hypertension-drug-.html Mon, 05 Nov 2018 11:45:00 +0530 Aurobindo Pharma Limited has initiated voluntary recall of 22 batches of drug substance Irbesartan, used in treatment of hypertension, from the US market due to the presence of an impurity, which is believed to cause cancer, the US Food and Drug Administration has announced. The impurity, N-nitrosodiethylamine (NDEA), is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes and has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC), the FDA said. According to a notification by the American drug regulator on its website, these 22 batches of Irbesartan drug substance were supplied by the city-based Aurobindo to ScieGen Pharmaceuticals Inc., US, for manufacturing finished Irbesartan drug for the treatment of hypertension. It may be used alone or in combination with other anti-hypertensive agents. The finished Irbesartan drug of 75 mg, 150 mg, and 300 mg manufactured by ScieGen Pharmaceuticals Inc have been labeled as Westminster Pharmaceuticals and Golden State Medical Supply, Inc (GSMS). “Aurobindo Pharma Limited has notified ScieGen Pharmaceuticals, Inc. of the recall and is arranging for the return of all available Irbesartan drug substance,” the FDA said. The company further advised Sciegen Pharmaceuticals, Inc. to contact its distributors and retailers for a return of identified batches of Irbesartan drug product and finished Irbesartan tablets, it added. ]]> <![CDATA[Roche's new drugs will replace lost sales: Schwan]]> https://biospectrumindia.com/news/95/11967/roches-new-drugs-will-replace-lost-sales-schwan.html https://biospectrumindia.com/news/95/11967/roches-new-drugs-will-replace-lost-sales-schwan.html Mon, 05 Nov 2018 11:20:00 +0530 Roche Chief Executive Severin Schwan said new drugs the pharma company is developing will replace the roughly 10 billion Swiss francs ($9.97 billion) lost from old cancer drugs. Roche's three best-selling drugs - all for cancer - had combined sales of $21 billion last year, accounting for 40 percent of the company’s overall sales. But the drugs - Rituxan, Herceptin, and Avastin  - now face a steep decline due to cheap near-copies, known as biosimilars, made by rivals including Switzerland's Novartis and South Korea's Celltrion "We have five, six cancer products potentially worth billions (of Swiss francs)," Schwan said "In addition to multiple sclerosis, there are also new drugs for haemophilia or nerve diseases. In sum, they will replace the lost sales." He further stated.  ]]> <![CDATA[Zydus Cadila launches generic erectile dysfunction drug in US]]> https://biospectrumindia.com/news/95/11958/zydus-cadila-launches-generic-erectile-dysfunction-drug-in-us.html https://biospectrumindia.com/news/95/11958/zydus-cadila-launches-generic-erectile-dysfunction-drug-in-us.html Fri, 02 Nov 2018 09:55:00 +0530 Drug firm Zydus Cadila has said that it has launched generic Vardenafil Hydrochloride tablets used for the treatment of erectile dysfunction in the American market. The company has launched the tablets in the strengths of 2.5 mg, 5 mg, 10 mg and 20 mg in the US market after receiving the final approval from the United States Food and Drug Adminstration (USFDA), Zydus Cadila said in a statement. The product will be manufactured at the group's formulations manufacturing facility at SEZ, Ahmedabad, it added. The group has also received the final approval from the USFDA to market generic Ursodiol tablets, 250 mg and 500 mg, which will be manufactured at the group's formulations manufacturing facility at Baddi, Zydus Cadila said. The Ursodiol tablets are indicated for the treatment of patients with primary biliary cirrhosis, a chronic disease in which the bile ducts in liver are slowly destroyed, it added. The group now has 226 approvals and has so far filed over 330 abbreviated new drug applications (ANDAs) since the commencement of its filing process. ]]> <![CDATA[Glenmark launches Nourkrin to treat hair loss in Russia ]]> https://biospectrumindia.com/news/95/11957/glenmark-launches-nourkrin-to-treat-hair-loss-in-russia-.html https://biospectrumindia.com/news/95/11957/glenmark-launches-nourkrin-to-treat-hair-loss-in-russia-.html Thu, 01 Nov 2018 18:05:00 +0530 Glenmark Pharmaceuticals, a research-led globally integrated pharmaceutical company, today announced the launch of Nourkrin in Russia. Nourkrin is a globally renowned, clinically-proven proteoglycan replacement formula, for addressing one of the key underlying causes of hair loss in males and females. Nourkrin Woman and Nourkrin Man will be exclusively marketed in Russia by Glenmark Impex LLC, the Russian subsidiary of Glenmark Pharmaceuticals Ltd., under a licensing agreement with Denmark headquartered firm Pharma Medico ApS. Glenmark had already launched NourkrinÂ® Woman in India in early 2018. Nourkrin contains Marilex, a unique and proprietary scientific formula, rich in specific proteoglycans essential for hair follicle growth. Nourkrin is a proven formula based on more than 56 scientific studies and is recognized by leading regulatory agencies globally. ''We are very happy to launch Nourkrin for both women and men in Russia. It is a much-awaited product, as the problem of hair loss affects quite a significant proportion of the population. Glenmark has a strong portfolio of dermatology products in Russia offering patients relief from different types of skin disorders for several decades and Nourkrin will be a great addition to this portfolio,'' said, Csaba Kantor, Senior Vice President & Head, Asia, Russia & CIS, Glenmark Pharmaceuticals. Nourkrin Woman and Nourkrin Man, available as tablets, are easy-to-use therapy compared to clinical procedures and hair sprays and creams. The product will be available through retail pharmacy chains as well as online pharmacies. According to a survey conducted by market research firm GfK in 2017, 18.7 million women and 14.1 million men in Russia experienced hair loss over the preceding 12 months. ]]> <![CDATA[TAKE Solutions Q2 net profit up by 65.68%]]> https://biospectrumindia.com/news/95/11951/take-solutions-q2-net-profit-up-by-65-68.html https://biospectrumindia.com/news/95/11951/take-solutions-q2-net-profit-up-by-65-68.html Thu, 01 Nov 2018 11:50:00 +0530 TAKE Solutions, a globally recognized domain intensive services provider in Life Sciences, announced its financial results for Quarter and Half-Year ending 30th September 2018. The company reports a net profit of INR 607.93 Mn, growing at 65.68% as against INR 366.93 Mn in the year-ago period. Key Highlights from this quarter: Revenue at INR 5,158.79 Mn; growth of 39.08% Y-o-Y and 10.34% Q-o-Q; Profit at INR 607.93 Mn, growing at 65.68% Y-o-Y Gartner recognized TAKE Solutions amongst Top 20 Global Solution Providers in its Market Guide for Track-and-Trace and Serialization Software Providers for Life Sciences Companies Regulatory, clinical trials, Research & Development Awards and recognition Winner of the Golden Peacock Award for Excellence in Corporate Governance 2018 Increasing Traction in Consulting Business both in terms of Volume and Size Multi-year, Multi-million Dollar Engagement with top global pharma for Clinical Services Multiple Transformative Deals in Regulatory and Pharmacovigilance Srinivasan H R, Vice Chairman, and Managing Director, TAKE Solutions said, “TAKE recorded a high growth rate this quarter and we continue to invest ahead of the growth curve in the right technology and infrastructure to position us as the most preferred partner for global pharma. Our 2021 growth strategy is on track and we are seeing a consistent growth trajectory. We have a healthy cash balance and a strong pipeline of key prospects to complete our expansion in key markets including North America and Europe.” ]]> <![CDATA[Dr.Reddy’s launches Atomoxetine Capsules, USP in the U.S. Market]]> https://biospectrumindia.com/news/95/11946/dr-reddys-launches-atomoxetine-capsules-usp-in-the-u-s-market.html https://biospectrumindia.com/news/95/11946/dr-reddys-launches-atomoxetine-capsules-usp-in-the-u-s-market.html Wed, 31 Oct 2018 15:35:00 +0530 Dr. Reddy’s Laboratories Ltd., along with its subsidiaries together referred to as “Dr. Reddy’s” today announced the launch of Atomoxetine Capsules, USP, a therapeutic equivalent generic version of Strattera® (atomoxetine) Capsules in the United States market approved by the U.S. Food and Drug Administration (USFDA).  The Strattera® brand and generic had U.S. sales of approximately $304 million MAT for the most recent twelve months ending in August 2018 according to IMS Health.  Dr. Reddy’s Atomoxetine Capsules, USP is available in 10 mg, 18 mg, 25 mg, 40 mg, 60 mg, 80 mg, 100 mg with 30 counts bottle size.  Straterra® is a registered trademark of Eli Lilly and Company.   ]]> <![CDATA[Biocon ranks 7th on global Pharma & Biotech employers list 2018]]> https://biospectrumindia.com/news/95/11940/biocon-ranks-7th-on-global-pharma-biotech-employers-list-2018.html https://biospectrumindia.com/news/95/11940/biocon-ranks-7th-on-global-pharma-biotech-employers-list-2018.html Tue, 30 Oct 2018 14:55:00 +0530 Biocon Ltd, Asia’s premier biopharmaceuticals company, has moved up in the Top 10 Global Biotech Employers ranking for 2018 and continues to be the only Company from Asia to feature on the prestigious U.S.-based Science magazine's annual 'Science Careers Top 20 Employers' list, since its debut in 2012. Ranked at No. 7 amongst global pharma and biotech companies in 2018, Biocon’s position has moved up two ranks from No. 9 last year. Biocon has been recognized for these three key attributes: ‘innovative leader in the industry’, ‘is socially responsible’ and ‘makes changes needed´. The ranking is a result of a global survey conducted by the Science magazine to determine which companies in the biotech and pharmaceutical industry have the best reputations as employers globally. Kiran Mazumdar Shaw, CMD , Biocon said: “We are delighted to be ranked at No. 7 on Science magazine’s Top Global Pharma & Biotech Employers List for 2018. This is a recognition of Biocon's high-end scientific talent who are aligned with the vision of a socially responsible organization that is making a difference to global healthcare through innovation and affordable access for patients. It encourages us to continue our journey of endurance with a focus on nurturing a culture of quality and compliance aimed at operational excellence. It is also a recognition of the grit, courage and commitment needed to emerge among the frontrunners in the global biosimilars race while operating in India’s risk-averse investment environment.” The Science and Science Careers’ 2018 annual Top Employers Survey polled employees in the biotechnology, biopharmaceutical, pharmaceutical and related industries to determine the best employers in these industries, as well as their driving characteristics. This year more than 8,000 people participated, the most in the history of the survey; and these respondents were from North America (63%), Europe (24%), and Asia/Pacific Rim (9%); 93% of these were from biotechnology, biopharmaceutical, and pharmaceutical companies. The overall driving characteristics of top employers as per survey respondents are ‘innovative leader in the industry’, ‘work culture values aligned’, ‘treats employees with respect’, ‘is socially responsible’, and ‘makes changes needed’. Some of the other leading global players are Regeneron, Novozymes, Merck KGaA, Novo Nordisk, Genentech, AbbVie etc. ]]> <![CDATA[Glenmark gets USFDA nod for generic Derma-Smoothe Topical Oil]]> https://biospectrumindia.com/news/95/11937/glenmark-gets-usfda-nod-for-generic-derma-smoothe-topical-oil.html https://biospectrumindia.com/news/95/11937/glenmark-gets-usfda-nod-for-generic-derma-smoothe-topical-oil.html Tue, 30 Oct 2018 13:35:00 +0530 Glenmark Pharmaceuticals has said that it has received final approval from the US health regulator for generic version of Derma-Smoothe Topical Oil, used in the treatment of scalp psoriasis. "Glenmark Pharmaceuticals Inc, USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (USFDA) for Fluocinolone Acetonide Topical Oil, 0.01 per cent (scalp oil), a generic version of Derma-Smoothe/FS Topical Oil, 0.01 per cent (scalp oil), of Hill Dermaceuticals, Inc," the company said in a BSE filing. For the 12 months to September 2018, DermaSmoothe/FS Topical Oil, 0.01 per cent (scalp oil), achieved annual sales of around USD 14 million, Glenmark said, citing IQVIA sales data. The company's current portfolio consists of 141 products authorised for distribution at the US marketplace and 58 Abbreviated New Drug Applications (ANDAs) pending approval with the USFDA. ]]> <![CDATA[Vaseline enters in Clinical Care ]]> https://biospectrumindia.com/news/95/11933/vaseline-enters-in-clinical-care-.html https://biospectrumindia.com/news/95/11933/vaseline-enters-in-clinical-care-.html Tue, 30 Oct 2018 12:00:00 +0530 Vaseline, which has been treating consumer's skin for nearly 150 years, is introducing the next generation of healing with new Vaseline Clinical Care, a breakthrough line of dermatologist-tested hypoallergenic body products aimed to rescue hard-to-heal dry skin. Vaseline Clinical Care lotions help transforms extremely dry skin with fast-absorbing, hypoallergenic formulas that deliver clinical strength moisturization. As the original skin healer, Vaseline knows that hard-to-heal dry skin can be stressful and uncomfortable. While other lotions only temporarily relieve surface hydration, the innovative Clinical Care lotions deeply strengthen skin's moisture barrier using a unique Barrier Repair Complex, which is proven to transform skin from extremely dry to heal in five days. The line features six new products that offer treatment and relief from a variety of skin concerns which can be associated with situational and ongoing skin conditions. "At Vaseline, we're always striving to create the absolute best for our consumers, who aren't looking for short cuts when it comes to their skin health," says Dawn Hedgepeth, General Manager/Vice President of Hand & Body Lotion at Unilever. "We're truly thrilled to introduce Clinical Care and its deep healing powers to help people with all types of dry skin needs." ]]> <![CDATA[Mitra Biotech, Brigham and Women’s Hospital team up for Cancer Immunotherapies]]> https://biospectrumindia.com/news/95/11925/mitra-biotech-brigham-and-womens-hospital-team-up-for-cancer-immunotherapies.html https://biospectrumindia.com/news/95/11925/mitra-biotech-brigham-and-womens-hospital-team-up-for-cancer-immunotherapies.html Mon, 29 Oct 2018 14:55:00 +0530 Mitra Biotech is a global leader in advancing personalized oncology treatment and supporting more effective and efficient cancer drug development. Mitra is headquartered in Greater Boston and maintains a significant research and laboratory presence in Bengaluru, India. The company has announced a collaborative research partnership with Brigham and Women’s Hospital and the Department of Neurosurgery to further transform personalized immuno-oncology drug development. The agreement, with Dr Sean Lawler, PhD, assistant professor of medicine and managing director of the Harvey Cushing Neuro-oncology Laboratories at the Brigham, is to evaluate oncolytic viruses that have been developed in the Department of Neurosurgery at the hospital. These novel engineered versions of the Herpes Simplex Virus 1 (HSV-1), which have been extensively characterized preclinically, are capable of selective infection and replication within tumor cells, and can stimulate the immune system. Clinical trials are now underway at the Brigham to investigate oncolytic viruses in patients with the aggressive and incurable brain tumor glioblastoma multiforme (GBM). To better understand how oncolytic viruses work in human GBM patients, Dr Lawler is leveraging Mitra’s CANscript platform to study their biological mechanisms of action, with the goal of identifying key features involved in response to oncolytic virus therapy. “Currently, there is a lack of reliable methods to study oncolytic viruses in the laboratory that directly translate to in vivo human activity,” says Dr Lawler. He continues, “CANscript allows us to have insight into what type of patients produce response. For the first time, we may be able to predict how these oncolytic viruses might work in actual human patients, which helps us better determine trial populations.” Mitra’s CANscript platform is a human, immune-relevant ex vivo model that allows researchers and drug developers to understand the performance of novel agents, such as oncolytic viruses, in human tissue, providing an informed approach to clinical development and patient response. CANscript is a uniquely effective platform in which to test such an immune response because it recreates the in vivo tumor microenvironment, maintaining the heterogeneity of the tumor while preserving its immune compartment. ]]> <![CDATA[Dr. Reddy’s Q2 net profit surges up to 77%]]> https://biospectrumindia.com/news/95/11918/dr-reddys-q2-net-profit-surges-up-to-77.html https://biospectrumindia.com/news/95/11918/dr-reddys-q2-net-profit-surges-up-to-77.html Fri, 26 Oct 2018 16:55:00 +0530 Dr. Reddy’s, the Hyderabad-based pharma company’s net profit increased 76.84 percent year-on-year to Rs 504 crore in the July-September period, according to its exchange filing.  Revenue from pharmaceutical services and active ingredients rose 7 percent on a yearly basis to Rs 600 crore, while revenue from emerging markets and global generics rose 36 percent and 7 percent respectively to Rs 750 crore and Rs 3,050 crore.  The company’s operating income, or earnings before interest, tax, depreciation and amortisation, rose 25.5 percent on a yearly basis to Rs 865 crore the consensus estimate was Rs 732 crore. The operating margin expanded to 22.8 percent during the period from 19.4 percent.  “Going forward, our priority will be to resolve pending regulatory issues, and continue to work on execution and cost structures that will enable affordable medicines for more patients,” Co-Chairman GV Prasad said.  Shares of Dr. Reddy’s Laboratories fluctuated between gains and losses to trade higher at Rs 2,396 apiece after the results announcement. That’s against a 0.3 percent fall in the NSE Nifty Pharma Index.   ]]> <![CDATA[Philips launches first start-up programme for AI in healthcare ]]> https://biospectrumindia.com/news/95/11911/philips-launches-first-start-up-programme-for-ai-in-healthcare-.html https://biospectrumindia.com/news/95/11911/philips-launches-first-start-up-programme-for-ai-in-healthcare-.html Thu, 25 Oct 2018 15:25:00 +0530 Philips announced the launch of their first global startup collaboration program involving Philips’ innovation hubs in Cambridge (US), Eindhoven, Bengaluru and Shanghai, focused on the application of artificial intelligence in healthcare. The programme focuses on the application of AI-based clinical decision support tools, such as image interpretation, analysis and integration; and workflow tools like intelligent treatment plans for radiology, ultrasound and oncology. After careful analysis, the most promising 19 start-ups out of 750 applicants were selected for inclusion in Philips’ proven accelerator program for early-stage startup companies. Srinivas Prasad, CEO Philips Innovation Campus, Bengaluru, said, “The Indian Start-up ecosystem is demonstrating an increasing trend of applications based on deep learning and AI in the healthcare domain. Philips is engaging with entrepreneurs who are developing AI-enabled solutions for improving clinical and operational outcomes. This year, the chosen start-ups are unique and the team at Philips Innovation Campus is committed to helping startups strengthen their value proposition and become successful sustainable businesses.” The startup program at Philips Innovation Campus, Bangalore caters to innovation ecosystems across India, Japan, South East Asia, Australia, and New Zealand, Middle East and Turkey. The team screened more than 150 healthcare start-ups that had AI and radiology as part of their proposition and the most promising five start-ups joined the global cohort. They will now be coached and facilitated from Philips Innovation Campus, Bangalore and gain access to some of the best experts from the ecosystem.   ]]> <![CDATA[BRS Ventures to invest in Indian Healthcare]]> https://biospectrumindia.com/news/95/11909/brs-ventures-to-invest-in-indian-healthcare.html https://biospectrumindia.com/news/95/11909/brs-ventures-to-invest-in-indian-healthcare.html Thu, 25 Oct 2018 12:35:00 +0530 The UAE-based USD 3 billion BRS Ventures plans to acquire hospitals in India, as it looks to consolidate its healthcare practice. BRS Ventures through BR Life, which is a holding company for Indian healthcare enterprises, plans to invest USD 300 million in the country to acquire hospitals in various cities. “Our strategy is to acquire a majority stake in hospitals or fully acquire them, invest back and expand their operations,” Binay R Shetty, Vice-Chairman and CEO, BRS Ventures. BRS Ventures operates across eight main sectors, including healthcare. In the healthcare vertical, it has three separate entities, including NMS Royal Hospital, which owns a 3000-bed hospital in Abu Dhabi and is listed on the London Stock Exchange, with a market valuation of USD 10 billion. In India, BR Life has acquired five hospitals with total bed strength of 1500. “We expect to grow that to about 10,000 beds in another five years, which is comparable to any big hospital chain,” said Shetty. Shetty said the focus of the company is to provide affordable, high-quality healthcare and add value to the acquired properties. He said that acquisition of a large chain of hospitals can be challenging as it involves changing their culture. “We are not looking at profitability as our focus but want to add value, and we consider ourselves as long-term players in India,” he said. The group also runs a financial services company, Unimoni, which focuses on inward remittances. In India, it handles 10 per cent of inward remittances, with a total of about USD 7 billion.   ]]> <![CDATA[Sun Pharma launches psoriasis treatment drug Ilumya in US]]> https://biospectrumindia.com/news/95/11903/sun-pharma-launches-psoriasis-treatment-drug-ilumya-in-us.html https://biospectrumindia.com/news/95/11903/sun-pharma-launches-psoriasis-treatment-drug-ilumya-in-us.html Wed, 24 Oct 2018 12:25:00 +0530 Sun Pharmaceutical Industries has announced that it has launched its plaque psoriasis treatment drug Ilumya (tildrakizumab-asmn) in the US market. Ilumya in the strength of 100 mg/mL is now available in the US for the treatment of moderate-to-severe psoriasis, the company said in a statement. "The availability of Ilumya is an important milestone for Sun Pharma as we expand our speciality medicine portfolio in the US," Sun Pharma North America's CEO Abhay Gandhi said. Ilumya offers a new, safe and effective treatment option for people who are still struggling to manage their moderate-to-severe plaque psoriasis, he added. "We understand the importance of patient and physician choice, and are committed to making Ilumya among the most cost-effective treatments in the market today," Gandhi said. The company is working closely with relevant stakeholders to ensure that Ilumya, a monoclonal antibody, is accessible to the patients across the US who may benefit from this new treatment option, Sun Pharma said. ]]> <![CDATA[WHO prequalifies inactivated polio vaccine ShanIPV]]> https://biospectrumindia.com/news/95/11901/who-prequalifies-inactivated-polio-vaccine-shanipv.html https://biospectrumindia.com/news/95/11901/who-prequalifies-inactivated-polio-vaccine-shanipv.html Wed, 24 Oct 2018 11:55:00 +0530 Sanofi Pasteur, the vaccines division of Sanofi, is proud to announce that its standalone IPV (Inactivated Polio Vaccine) – ShanIPV, developed by its affiliate Shantha Biotechnics, has received prequalification status from the World Health Organization (WHO). This status qualifies ShanIPV vaccine for purchase by the United Nations’ agencies. The WHO prequalification programme is a service provided to the United Nations’ procurement agencies. The goal of the programme is to ensure that the vaccines used in immunization programmes are safe and effective, the vaccine efficacy data and studies are relevant to the target population, and that the vaccine meets the specific needs of the programme, reflected by the tender specifications: i.e. potency, thermostability, presentation, labeling, shipping conditions, etc. “WHO-prequalification of a vaccine is a stringent process wherein the WHO reviews the production process, quality control procedures, tests consistency of various batches and works closely with the responsible National Regulatory Authority in this process. The prequalification is testament to our commitment to provide high quality vaccines. ShanIPV™ plays a crucial part in keeping India polio-free and we are proud to have supplied more than 28 million doses of this vaccine to the Indian Government since 2015.” said Dr. Mahesh Bhalgat, Executive Director & COO, Shantha Biotechnics, a Sanofi Pasteur company. “Over the last two decades, Sanofi Pasteur has been serving the vaccination needs of India by making available the highest quality products. Today, the only 2 WHO-prequalified IPV containing vaccines that are available in India are both from Sanofi Pasteur (ShanIPV™ and Hexaxim®). Through our partnership with the Government of India, I’m proud to share that every one-out-of-two babies born in the country is protected with an IPV from Sanofi Pasteur.” said Jean-Pierre Baylet, Country Head – Sanofi Pasteur, India & South Asia. India is currently in its fifth year of being polio-free and its seventh, since the last reported polio case. According to the GPEI (Global Polio Eradication Initiative) Endgame Strategic Plan 2013-2018, introducing at least one dose of IPV in current polio eradication programs and completely switching from OPV to IPV in the next few years, is critical to ending polio transmission. As per the dashboard of India’s Ministry of Health & Family Welfare (April 2018), the coverage of IPV dose 1 is 62% and that of dose 2 is 52%. Given India’s high birth cohort, Sanofi Pasteur has invested significantly over the years to ensure access to high-quality vaccination against polio for a large number of babies in India. ]]> <![CDATA[Abbott brings two new web-based lab information management systems]]> https://biospectrumindia.com/news/95/11894/abbott-brings-two-new-web-based-lab-information-management-systems.html https://biospectrumindia.com/news/95/11894/abbott-brings-two-new-web-based-lab-information-management-systems.html Tue, 23 Oct 2018 11:00:00 +0530 Abbott announced the launch of two web-based laboratory information management systems to enable laboratories to make data management simpler, better integrated, and more user-friendly.  STARLIMS Life Sciences Solution CL 11.0, which includes the industries of pre-clinical, clinical research, biorepository, molecular and academic research, and STARLIMS Quality Manufacturing Solution QM 11.1, which includes the industries of pharmaceutical, biotech, chemical, food and beverage and petrochemical/refining, are both new offerings built on the latest version of the STARLIMS Technology platform 11.6.  Continual improvements in laboratory information management system (LIMS) platforms are crucial as regulatory scrutiny increases, the amount of data grows exponentially, many industries move towards molecular testing and precision medicine, and pressure mounts to bring new products to market faster.  Both new products are fully integrated solutions, which include an industry leading Advanced Analytics platform.  Advanced Analytics allows clients to analyze lab data via enhanced data visualization capabilities, which enables better, faster, and business-critical, decision making.  The integrated solution also includes a Scientific Data Management System (SDMS), Electronic Laboratory Notebook (ELN), and mobile capabilities, with a powerful LIMS as the centerpiece. "STARLIMS was designed to empower laboratories around the world to deliver high-quality, safe products to market as quickly as possible," said Mark Spencer, vice president and general manager, Informatics, Abbott. "These enhancements to STARLIMS Life Sciences and Quality Manufacturing solutions reflect Abbott’s ongoing commitment to innovation and meeting customer needs." STARLIMS Life Sciences Solution CL 11.0 features intuitive enhancements for streamlining sample management, simplifying accessioning, and interfacing with third-party instruments and the conversion to HTML5 web platform.  These upgrades are designed to increase lab flexibility, productivity and efficiency, and reduce the complexities of working with different software platforms. "Laboratories make major investments in analytical equipment, but interfacing proprietary instrument software directly with some LIMS can be problematic," said Mark Spencer. "Thanks to a partnership between Abbott and Data Innovation, the STARLIMS Life Sciences Solution can now connect directly with an even wider range of third-party instrumentation, giving laboratories more freedom to choose their tools based on scientific and business requirements rather than data system limitations." STARLIMS Quality Manufacturing Solution QM 11.1 offers the following benefits: Features a new, integrated request management portal, a user-friendly, customizable dashboard, and out-of-the-box, pre-aided graphical workflows for five key testing lifecycles (manufacturing, contract laboratories, stability, environmental, and process samples).  The integrated portal allows for direct management of test requests within the STARLIMS QM Solution, rather than the support of a third-party platform. Additional updates include Northwest Analytical (NWA) trending enhancements, mobility applications, and regulatory and performance enhancements. Supports laboratory productivity and efficiency across diverse sectors of the global manufacturing industry.  "Manufacturers can operate more effectively if they have a real-time, holistic view of workflow progress in their laboratories," adds Spencer. "The product enhancements in the new version of the STARLIMS QM Solution not only provide an intuitive visual interface but also help ensure transparency and support regulatory compliance."   ]]> <![CDATA[Lupin receives FDA approval for generic skin ointment]]> https://biospectrumindia.com/news/95/11892/lupin-receives-fda-approval-for-generic-skin-ointment.html https://biospectrumindia.com/news/95/11892/lupin-receives-fda-approval-for-generic-skin-ointment.html Tue, 23 Oct 2018 10:50:00 +0530 Pharma major Lupin announced that it has received approval for its Triamcinolone Acetonide Ointment USP, 0.1% from the United States Food and Drug Administration (FDA) to market a generic version of Mylan Pharmaceuticals, Inc.’s (Mylan) Triamcinolone Acetonide Ointment, 0.1%. Lupin’s Triamcinolone Acetonide Ointment USP, 0.1% is the generic version of Mylan’s Triamcinolone Acetonide Ointment, 0.1%. It is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Triamcinolone Acetonide Ointment USP, 0.1% had annual sales of approximately $ 25.7 million in the US (IQVIA MAT June 2018). ]]> <![CDATA[ Strides Pharma gets USFDA nod for its anti-epileptic drug]]> https://biospectrumindia.com/news/95/11890/-strides-pharma-gets-usfda-nod-for-its-anti-epileptic-drug.html https://biospectrumindia.com/news/95/11890/-strides-pharma-gets-usfda-nod-for-its-anti-epileptic-drug.html Mon, 22 Oct 2018 13:30:00 +0530 Strides Pharma Science (Strides) on Saturday announced that its global arm Strides Pharma Global Pte Singapore has received USFDA approval for Gabapentin capsules. Gabapentin capsules is a generic version of Neurontin capsules of Pfizer Inc.  The product received approval in the first cycle of review of 10 months under the GDUFA II regime. The drug will be available in three doses of 100 mg, 300 mg, and 400 mg. The US market for these three doses is $270 million. The medicine is a generic version of Neurontin capsules of Pfizer, and is an antiepileptic drug used with other medications to prevent and control seizures. It is also used to relieve nerve pain following shingles, in adults. The product will be marketed by Stride Pharma in the US market. ]]> <![CDATA[Lupin Neurosciences receives CHMP nod for NaMuscla]]> https://biospectrumindia.com/news/95/11889/lupin-neurosciences-receives-chmp-nod-for-namuscla.html https://biospectrumindia.com/news/95/11889/lupin-neurosciences-receives-chmp-nod-for-namuscla.html Sun, 21 Oct 2018 16:10:00 +0530 Lupin Neurosciences, a specialty pharma division of Lupin Ltd, recently announced that the Committee for Medicinal Products for Human Use (CHMP), the scientific committee of the European Medicines Agency (EMA), has adopted a positive opinion recommending the marketing authorization of NaMuscla (mexiletine hydrochloride) for the symptomatic treatment of myotonia in adults with non-dystrophic myotonic (NDM) disorders. Non-dystrophic myotonic disorders are a group of rare, inherited neuromuscular disorders which cause the inability of muscle relaxation following voluntary contraction. NaMuscla reduces myotonia symptoms in adult patients, resulting in a significant improvement in patient quality-of-life and other functional outcomes. The CHMP’s positive opinion will now be reviewed by the European Commission (EC), which has the authority to approve medicines for the European Union (EU). The EC decision is expected within three months and will apply to all 28 countries of the European Union, Norway, Iceland and Liechtenstein. If approved, NaMuscla will be the first treatment licensed throughout the EU for the symptomatic treatment of myotonia in adults with NDM disorders. The therapy had already been awarded Orphan Drug designation. “With this positive CHMP opinion we are now one step closer to offering NaMuscla to patients with non-dystrophic myotonia, for whom there are currently no licensed treatment options available across all EU countries”, said Thierry Volle, President EMEA, Lupin. “We eagerly await the next step; namely the European Commission’s decision, but the positive opinion represents an important milestone for Lupin Neurosciences as we build a leading specialty pharma company focused on the development, registration and commercialization of science-based therapies and solutions for neurological disorders that can restore function and significantly improve lives.” The positive opinion from the CHMP was based on a pivotal Phase III clinical study (MYOMEX) which enrolled 25 participants who were diagnosed with non-dystrophic myotonic disorders and symptomatic myotonia, in addition to bibliographical references, including three controlled clinical studies, to support the efficacy and safety of mexiletine. Today, more than 7500 people in Europe living with NDM have limited access to a licensed treatment for myotonia which reduces the daily burden of this life-altering symptom. Limited access leads to inconsistent medication supply, administrative challenges and associated financial and geographical burdens, which, along with low awareness and clinical experience among healthcare professionals, may result in harm to patients. “The positive CHMP opinion in favour of the registration of NaMuscla (mexiletine hydrochloride) for the symptomatic treatment of myotonia in adults with non-dystrophic myotonic disorders is a very positive step towards meeting the significant unmet medical needs of this patient group across the European Union,” said Prof. Dr. med. Benedikt Schoser, FEAN (Neurologische Klinik und Poliklinik, Klinikum der Universität München). “Untreated myotonia in NDM patients can lead to significant lifetime disability due to the stiffness, pain and fatigue associated with myotonic syndromes. Access to a consistent mexiletine formulation is the first step in removing barriers to myotonia treatment and optimizing care for these patients.” ]]> <![CDATA[Biocon, Mylan receive positive CHMP opinion for Ogivri]]> https://biospectrumindia.com/news/95/11885/biocon-mylan-receive-positive-chmp-opinion-for-ogivri.html https://biospectrumindia.com/news/95/11885/biocon-mylan-receive-positive-chmp-opinion-for-ogivri.html Fri, 19 Oct 2018 19:30:00 +0530 Biocon Ltd. and Mylan N.V. have announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending approval of Ogivri, a biosimilar to Roche’s Herceptin (trastuzumab). The positive CHMP opinion is based on data submitted as part of the Marketing Authorization Application which included similarity assessment in analytical testing, preclinical and clinical studies. Results demonstrated no clinically meaningful differences in quality, potency and safety; therefore, establishing biosimilarity to the reference product, Herceptin. In addition, the Phase III clinical study (Heritage) demonstrated no clinically meaningful differences in terms of safety, efficacy and immunogenicity when compared to Herceptin in metastatic breast cancer patients, further reinforcing the highly similar nature of Ogivri.    The CHMP positive opinion will now be considered by the European Commission. The decision on approval is expected by the end of 2018. Ogivri is indicated for treatment of patients with HER2 positive early breast cancer (EBC), metastatic breast cancer (MBC) and metastatic gastric cancer (MGC). Under supervision of the relevant healthcare professional it can be prescribed as either monotherapy or in combination with other medicines dependent on the relevant diagnosis. Dr Arun Chandavarkar, CEO and Joint Managing Director, Biocon said: “CHMP's positive opinion on Biocon and Mylan's biosimilar Trastuzumab is yet another endorsement of our ability to develop and manufacture complex biosimilars for the benefit of patients globally.  This is the third molecule from our collaboration portfolio to receive positive opinion from the European CHMP.  We shall continue to execute on our biosimilars strategy of expanding affordable access to high quality products targeting critical illnesses like cancer.” Mylan President Rajiv Malik commented: “Obtaining positive CHMP opinion for Ogivri is another significant achievement in Mylan’s continued efforts to bring more affordable medicines to the market. The strong science and technology program behind this product has been instrumental in achieving this milestone and moving us one step closer to providing patients with this alternative option. Mylan has a comprehensive and diverse biosimilars portfolio, and we are dedicated to bringing these complex medicines to market around the world.” Herceptin had brand sales of approximately $1.9 billion in Europe for the 12 months ending July 31, 2018, according to IQVIA. Ogivri was approved by the U.S. Food and Drug Administration (FDA) in 2017 and is the first FDA-approved biosimilar for Herceptin in the U.S. Additional regulatory approvals have been secured in 35 countries around the world. ]]> <![CDATA[Piramal Pharma becomes Industry Partner of the Year]]> https://biospectrumindia.com/news/95/11880/piramal-pharma-becomes-industry-partner-of-the-year.html https://biospectrumindia.com/news/95/11880/piramal-pharma-becomes-industry-partner-of-the-year.html Fri, 19 Oct 2018 13:15:00 +0530 Piramal Pharma Solutions (PPS) has been recognized as the Industry Partner of the Year at the prestigious Global Generics & Biosimilars Awards 2018, held recently in Madrid, Spain. This is the second consecutive year that PPS has won this coveted award. PPS competed with several global peers for this recognition in a category that resonates with the Piramal Group’s core belief of building strong collaborations with its strategic partners. Vivek Sharma, Chief Executive Officer, Piramal Pharma Solutions said, “We are honored to receive this award, and I congratulate the Piramal Pharma Solutions team that made this victory possible through its collective efforts and dedication. We focus on Customer Centricity, Quality, and Innovation as the foundation for strong collaborations, as we strive to become the ‘Partner of Choice’ for our customers. One of our stated goals is to work with our partners to improve affordability, accelerate timelines, and increase accessibility to life saving medicines that impact human lives. This recognition serves as a testament to the progress that we have made, and I would like to thank our partners for their trust in us, and our peers for their efforts in improving health care. It is gratifying that all of us work in an industry that makes an impact on bettering human life. This recognition motivates us to better ourselves at delivering innovative solutions to our customers and end patients.” The Global Generics & Biosimilars Awards are amongst the most coveted recognitions in the pharmaceutical industry, that recognize the efforts made by global generics and biosimilars sectors, to make affordable medicines available to more patients across the globe. ]]> <![CDATA[Novartis to acquire Endocyte in $2.1B deal]]> https://biospectrumindia.com/news/95/11877/novartis-to-acquire-endocyte-in-2-1b-deal.html https://biospectrumindia.com/news/95/11877/novartis-to-acquire-endocyte-in-2-1b-deal.html Fri, 19 Oct 2018 11:05:00 +0530 Novartis AG will acquire U.S.-based cancer drugmaker Endocyte Inc for $2.1 billion in cash as the Swiss drugmaker expands its radiopharmaceuticals business. The $24-per-share offer represents a premium of 54 percent to Endocyte's Wednesday closing price. Endocyte said the deal will help develop a broader role for radioligand therapies in cancer treatment. The deal will also enable Novartis to investigate the potential development of a drug candidate for use in earlier lines of prostate cancer therapy. Endocyte will be merged with a newly formed Novartis subsidiary. The transaction is expected to be completed in the first half of 2019 and Endocyte will continue to operate as a separate and independent company until then. Novartis said in September that it will cut 2,550 jobs in Switzerland and Britain over four years, as it strives to boost profits and focus on new medicines. ]]> <![CDATA[Zydus Cadila to market generic gout attacks drug in US]]> https://biospectrumindia.com/news/95/11876/zydus-cadila-to-market-generic-gout-attacks-drug-in-us.html https://biospectrumindia.com/news/95/11876/zydus-cadila-to-market-generic-gout-attacks-drug-in-us.html Fri, 19 Oct 2018 10:50:00 +0530 Drug firm  Zydus Cadila has received a tentative nod to market generic Colchicine tablets used for prevention and treatment of gout attacks in the US market. The company has received the tentative approval from the United States Food and Drug Administration (USFDA) to market Colchicine tablets USP in the strength of 0.6 mg, Zydus Cadila said in a statement.  The product is the generic version of Colcyrs tablets in the same strength, it added.  The tablets "will be manufactured at the group's formulations manufacturing facility at SEZ, Ahmedabad," it said.  The drug is used to prevent or treat attacks of gout, a condition caused by high uric acid levels in the blood. The medication is also used to treat familial Mediterranean fever.  The group now has 223 approvals and has so far filed over 330 abbreviated new drug applications (ANDAs) since the commencement of its filing process, Zydus Cadila said.   ]]> <![CDATA[Mylan Hackathon develops solutions for healthcare challenges]]> https://biospectrumindia.com/news/95/11865/mylan-hackathon-develops-solutions-for-healthcare-challenges.html https://biospectrumindia.com/news/95/11865/mylan-hackathon-develops-solutions-for-healthcare-challenges.html Tue, 16 Oct 2018 16:30:00 +0530 Mylan Pharmaceuticals Private Limited announced the winners of its second edition of the Mylan Hackathon held in Bengaluru. The two-day event took place on October 13 and 14, at Mylan’s Global Centre in the city, where students and professionals connected and collaborated with people at Mylan to innovate solutions that address real-world health challenges. For the Professional Hackers Category, Team Smart from Atos won for their novel solution to adherence of treatment of TB patients. For the Students Category, Team from Sri Sairam Institute of Technology wons for its solution for tracking ARV medicines till it reaches the consumer. Commenting on the initiative, Mylan spokesperson Rakesh Bamzai, President – India and Emerging Markets said, “We are proud to be one of the few pharmaceutical companies in the world to host a hackathon for digital innovation. Initiatives such as these foster engagement and collaboration between students, professionals and institutions, to develop innovative and cost-effective solutions for real-world health problems and enhance access to affordable medicines. At Mylan, the Hackathon initiative focuses not only on the current challenges in Healthcare, but also on developing solutions for the future". This year, the Hackathon teams were asked to ‘Hack for a Cause’ to find solutions to leading healthcare challenges such as adverse event / side effect reporting of pharmaceutical products; detection of early signs and symptoms of cancer and addressing the resource scarcity problem by automating preliminary analysis of reports; a patient’s real-world outcome tracking through technology/AI; patient’s adherence to TB treatment and traceability of Mylan’s ARV drugs to the end consumer. The 2018 event attracted more than 200 participants from 44 cities across India who were joined by Mylan employees and Mylan coaches. The two-day event included top notch giveaways, spot quizzes and a session with Shakthi Vadakkepat, founder of The Quill, who spoke to the participants about innovation driven solutions to today's medical problems. One of the members of the winning team, Ganesh Mahadevan said, “This event was an exceptional learning platform for me. It allowed me to interact and collaborate with brilliant like-minded innovators to develop solutions that could have a positive impact on patients and the industry. I believe that anyone who wants to find viable solutions for health problems should participate in the Mylan Hackathon.” Mylan held its first hackathon in India in 2016 and has since been fueling the push for new creative and innovative solutions in the healthcare segment for patients, payers, providers and other healthcare professionals. Mylan Pharmaceuticals, a global pharmaceutical company has an ambitious mission of providing the world’s 7 billion people access to high quality medicine. The Hackathon is conducted by Mylan in India and globally. ]]> <![CDATA[Alembic Pharma receives USFDA approval for diabetes drug]]> https://biospectrumindia.com/news/95/11864/alembic-pharma-receives-usfda-approval-for-diabetes-drug.html https://biospectrumindia.com/news/95/11864/alembic-pharma-receives-usfda-approval-for-diabetes-drug.html Tue, 16 Oct 2018 15:55:00 +0530 Drug firm Alembic Pharmaceuticals has received tentative nod from the US health regulator for its Alogliptin tablets used for treatment of type 2 diabetes.  The company has received tentative approval from the US Food and Drug Administration (USFDA) for its Alogliptin tablets in the strengths of 6.25 mg, 12.5 mg and 25mg, Alembic Pharma said in a BSE filing.  The product is generic version of Takeda Pharms USA's Nesina tablets in the same strengths. The tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus, Alembic Pharma said. "Alogliptin tablets, 6.25 mg, 12.5 mg and 25mg has an estimated market size of USD 65.6 million for twelve months ending December 2017 according to IQVIA," it added. The company now has a total of 78 abbreviated new drug application (ANDA) approvals (64 final approvals and 14 tentative approvals) from USFDA, Alembic Pharma said. ]]> <![CDATA[Medlife awarded India’s Best Pharma Delivery e-Platform Company ]]> https://biospectrumindia.com/news/95/11861/medlife-awarded-indias-best-pharma-delivery-e-platform-company-.html https://biospectrumindia.com/news/95/11861/medlife-awarded-indias-best-pharma-delivery-e-platform-company-.html Tue, 16 Oct 2018 11:30:00 +0530 Medlife, India’s largest online e -pharmacy Company, has been awarded India’s Best Pharma Delivery e-Platform Company of the Year by Frost & Sullivan at the 5th Annual 2018 India Best Practices Awards. The Annual Best Practices Awards in India is presented across industry sectors such as Electronics & Appliances, Energy & Environment, Digital media, Industrial Automation & Process Control, Metals & Minerals, Mobility, Tech Vision and Transformational Health, following a comprehensive research and analysis were done by the eminent jury members.  Frost & Sullivan Best Practices Awards is part of the Global program that recognizes outstanding industry achievements by companies across the globe. It recognizes companies for their overall performance and efforts in achieving excellence in the ever-changing business environment through superior leadership, technological innovation, customer service and strategic product development.  Medlife with a market share of over 45% in the e-pharmacy space in India has been exploring newer horizons in Tier 2 and Tier 3 cities and not restricting its operations to Metros while developing various customer-centric healthcare product and services and providing the solution to people belonging to every pocket of the society.  Medlife strives to be the best in the healthcare hub, with intent to offer its users the convenience of an online pharmacy where one can get prescribed medicines delivered at your doorstep in a hassle-free manner. Adhering to all the applicable laws and regulations, they have successfully branched their operations in over 465+ cities.   ]]> <![CDATA[Dr. Reddy's gets USFDA nod for Aspirin, Extended-Release Dipyridamole capsules ]]> https://biospectrumindia.com/news/95/11858/dr-reddys-gets-usfda-nod-for-aspirin-extended-release-dipyridamole-capsules-.html https://biospectrumindia.com/news/95/11858/dr-reddys-gets-usfda-nod-for-aspirin-extended-release-dipyridamole-capsules-.html Mon, 15 Oct 2018 17:25:00 +0530 Dr. Reddy’s Laboratories Ltd announced receipt of approval for Aspirin and Extended-Release Dipyridamole Capsules, a therapeutic equivalent generic version of Aggrenox (aspirin and extended-release dipyridamole) Capsules in the United States market from the U.S. Food and Drug Administration (USFDA). The Company is working towards launching the product. The Aggrenox brand and generic had U.S. sales of approximately $183 million MAT for the most recent twelve months ending in August 2018 according to IMS Health. Dr. Reddy’s Aspirin and Extended-Release Dipyridamole Capsules are available in 25 mg/200 mg strength with 60 count bottle size. Aggrenox is a registered trademark of Boehringer Ingelheim.       ]]> <![CDATA[ Dr. Reddy's to sell API unit to Therapiva]]> https://biospectrumindia.com/news/95/11857/-dr-reddys-to-sell-api-unit-to-therapiva.html https://biospectrumindia.com/news/95/11857/-dr-reddys-to-sell-api-unit-to-therapiva.html Mon, 15 Oct 2018 17:15:00 +0530 Dr. Reddy’s Laboratories Ltd. along with its subsidiaries together referred to as “Dr. Reddy’s” has announced that it has entered into a definitive agreement for the sale of its API manufacturing business unit  located in Jeedimetla, Hyderabad, to Therapiva Private Ltd, an emerging generics pharmaceutical company. This divestiture is being done by way of slump sale (as a going concern) and includes all related fixed assets (land and building), current assets, current liabilities, and its employees.  “The divestiture of our API manufacturing business unit is a step towards streamlining our manufacturing operations and optimizing our cost structures,” said Sanjay Sharma, Executive Vice President & Head, Global Manufacturing Operations. “We are confident that we have found in Therapiva, a buyer-partner who fully understands and appreciates the business unit and its people as a powerful strategic asset.” Therapiva Private Limited is a joint venture between Omnicare Drugs India Private Limited (100% subsidiary of Neopharma LLC, Abu Dhabi) and Laxai Life Sciences Private Ltd.  “This acquisition represents a unique opportunity to further strengthen Therapiva’s position as a premier supplier of APIs. There is a strong cultural fit between our companies and we are excited to welcome the employees of Dr. Reddy’s to accelerate our ambitious growth plans.” said Vamsi Maddipatla, CEO of Therapiva and Laxai Life Sciences.  “We are very excited with this acquisition which will augment Neopharma’s vertical integration advantage and provide us with a high quality manufacturing base in India. This is a key milestone in our acquisition strategy over the next few years to increase Neopharma’s presence in the global generics space" said BR Shetty, Chairman of Neopharma LLC, Abu Dhabi.   ]]> <![CDATA[Nayati Healthcare introduces eICU at Nayati Medicity in Mathura]]> https://biospectrumindia.com/news/95/11855/nayati-healthcare-introduces-eicu-at-nayati-medicity-in-mathura.html https://biospectrumindia.com/news/95/11855/nayati-healthcare-introduces-eicu-at-nayati-medicity-in-mathura.html Mon, 15 Oct 2018 13:00:00 +0530 Nayati Healthcare has announced the introduction of India’s first Digital Intensive Care units (eICU) at its flagship hospital, Nayati Medicity at Mathura. The introduction of the state of the art technology, reiterates Nayati’s commitment of bringing the world’s most advanced healthcare services and technology to the people in Tier 2 and Tier 3 cities. With this, Nayati Medicity has become India’s first hospital to adopt a secured cloud-based model which uses minimal infrastructure cost, making it affordable. The technology, introduced in collaboration with Cohere Med, a health-tech company based in Bangalore, will allow clinicians to monitor multiple critically ill patients remotely, alert ICU staff to any issues, and ensure early intervention to improve outcomes.  The newly installed system uses Critibot (a registered trademark of Cohere Med) a bot built to serve customized information for every doctor. The goal is to optimize clinical expertise and facilitate 24-hour-a-day care by ICU caregivers. ]]> <![CDATA[Concept Medical raises $60M for innovative Sirolimus-Coated Balloon]]> https://biospectrumindia.com/news/95/11853/concept-medical-raises-60m-for-innovative-sirolimus-coated-balloon.html https://biospectrumindia.com/news/95/11853/concept-medical-raises-60m-for-innovative-sirolimus-coated-balloon.html Mon, 15 Oct 2018 11:20:00 +0530 Concept Medical Inc. raises $60 million for Investigational Device Exemption (IDE) for the world's first sirolimus-coated balloon. Sirolimus balloon catheter is a drug-coated balloon, which is a replacement of the stent. If a stent cannot be placed in a human body or doesn't have a good outcome, then sirolimus balloon is used. Concept Medical Inc. (CMI) has approached the FDA for an Investigational Device Exemption (IDE) for their Sirolimus-Coated Balloon (DCB). To support this process, they have raised $60mn (for an undisclosed valuation) from cardiologist and serial entrepreneur Dr. Kiran Patel. An IDE allows the investigational device to be used in a clinical study to collect safety and effectiveness data. The funds will also be utilized to augment clinical data and clinical registries to qualify for reimbursement in the European markets, where the Company has commercially launched the product. CMI, headquartered in Florida, has a manufacturing subsidiary in India, by the name, Envision Scientific Pvt. Ltd. (ESPL), where all their products are made. A portion of the funds will also be utilized to bolster the manufacturing operations to meet the increasing demand for their products globally. Their global distribution and marketing network are operated from offices in India, Singapore, Netherlands and Brazil. ESPL also has an India-focused, marketing and distribution business. The Companies (CMI and ESPL), which were established about 10 years ago, have developed innovative and disruptive platform technologies in drug-delivery systems to address the unmet medical needs in interventional cardiology. They have 96 patents granted (another 40 under process) around the world in major markets like USA, China, Japan, Europe, India, Australia and others. They have, since, successfully commercialized globally, their first product, "Abluminus-DES coronary stent", using their proprietary drug delivery and coating systems. "MagicTouch-DEB" (sirolimus-coated balloon with application in coronary and peripheral artery disease), is commercially sold in many European countries including the UK and other countries like South Africa, Mexico, Malaysia, Indonesia, Singapore, MENA region. Extended applications of "MagicTouch-DEB" in Renal transplant, Erectile dysfunction, and AVF/AVG for Renal dialysis patients are under on-going clinical trials. CMI raised the funds from the family office of 'Dr. Kiran and Pallavi Patel'. With the fresh infusion of funds, both CMI and ESPL aim to bolster their operations in the existing and new markets. ]]> <![CDATA[OPPI releases Shaping India’s OTC Policy 2018 ]]> https://biospectrumindia.com/news/95/11847/oppi-releases-shaping-indias-otc-policy-2018-.html https://biospectrumindia.com/news/95/11847/oppi-releases-shaping-indias-otc-policy-2018-.html Fri, 12 Oct 2018 18:15:00 +0530 On behalf of the pharmaceutical industry in India, the Organisation of Pharmaceutical Producers of India (OPPI), along with a few members from the domestic pharmaceutical industry and consumer industry, released a study titled Shaping India’s OTC Policy 2018 at the Annual CubeX-Nicholas Hall OTC Conference, held in Mumbai, recently.  In collaboration with CubeX and the Nicholas Hall Group of Companies, this Study calls for a well-regulated OTC framework that not only helps improve access to medicines but also supports responsible self-medication to achieve multiple health and economic objectives. While proposing the policy for India, the study- Shaping India’s OTC policy 2018- considers the best practices that have been adopted by the most evolved OTC markets of US and UK, the most dynamic OTC market of China, the well-defined OTC market of Australia and the evolving OTC markets of Brazil, Indonesia and Mexico. Commenting on the release of the Study, A. Vaidheesh, President-OPPI and Managing Director-India & Vice President- South Asia, Glaxo SmithKline Pharmaceuticals Ltd said, “Access to medicines in India has long ignored the critical role of the viability of OTC medicines in the remotest areas. A well-regulated OTC guideline will expand access for patients. Shaping India’s OTC Policy 2018 is an illustration of the collaborative effort of the entire pharmaceutical industry in empowering patients to make responsible and wise choices and self-manage their health outcomes.” “OTC medicines save health systems valuable resources and can save consumers time and money. However, consumers need to be educated on the practice of healthy living habits and self-care.  OTC medicines have played a significant role in expanding access to safe and effective treatments in developing regions of the world,” said G. Sathya Narayanan, Chairman-OPPI OTC Taskforce and Managing Director, South Asia, Nestle Skin Health India Pvt Ltd. Some key recommendations of the Study include: the need for a legislation that would serve as the principal law regulating import, manufacture, promotion, distribution and sale of OTC drugs. Hence, the suggestion to include a separate Rule and a separate Schedule on OTC (proposed nomenclature Schedule “O”) in the Drugs and Cosmetics Act, 1940 and Drugs and Cosmetics Rules, 1945. the need for essential parameters such as quality, safety and efficacy standards to remain the same as for “Prescription” drugs Kanchana TK, Director General, OPPI added, “OPPI keeps the patient at the core of all our activities.  A well-regulated OTC guideline promotes a favourable ecosystem that educates patients on responsible self-medication, empowering them to manage their health by themselves.” ]]> <![CDATA[ AMETEK India opens technology solutions centre in Bangalore]]> https://biospectrumindia.com/news/95/11843/-ametek-india-opens-technology-solutions-centre-in-bangalore.html https://biospectrumindia.com/news/95/11843/-ametek-india-opens-technology-solutions-centre-in-bangalore.html Fri, 12 Oct 2018 13:20:00 +0530 AMETEK Instruments (India) Pvt. Ltd. has established a technology solutions centre at its headquarters in Whitefield, Bangalore, to support the growth of its electronic instrument and electromechanical products businesses in India. AMETEK invested $5.5 million in establishing the Technology Solutions Centre and expects it to be a great resource for its customers in designing new products, selecting the right equipment to meet their application needs, servicing and calibrating devices, and providing hands-on demonstrations and training. AMETEK India is a unit of AMETEK, Inc., a leading global manufacturer of electronic instruments and electromechanical devices with annualized revenue of more than $4.8 billion and headquartered in Berwyn, Pennsylvania, USA. AMETEK has 17,000 colleagues at more than 150 operating locations, and a global network of sales, service and support locations in 30 countries around the world. “We are very pleased with our new Technology Solutions Centre. It represents a significant expansion of our technical and support capabilities in India and reflects the importance of our growing customer base in India. We now can provide customers with a wider range of services and support, including product demonstrations, training seminars and application workshops, along with factory-direct service, repair and support,” commented Milind Palsule, AMETEK Managing Director for India and the Middle East. AMETEK is celebrating 10 years in India we expect very strong growth in as we continue to expand our capabilities and presence across India. It is not only a key market but a great resource for global R&D hub & sourcing too and AMETEK is committed to investing in India growth & supporting our customers, commented Emanuela Speranza, VP & GM of AMETEK Europe, India and Brazil. The Centre is equipped with products from nearly 20 AMETEK businesses. It showcases the latest AMETEK solutions for Aerospace & Defense, Academia & Scientific Research, Automotive, Power, Metal, Pharma and Process instrumentation, Factory automation, and Precision manufacturing instruments and electro-mechanical devices. Among AMETEK India’s customers are many of India’s leading companies in aerospace; automotive manufacturing; energy production; glass, metal and steel processing; industrial and academic research; ultraprecision manufacturing, and other high technology fields. ]]> <![CDATA[OPPI advocates for policies that promote scientific temperament]]> https://biospectrumindia.com/news/95/11834/oppi-advocates-for-policies-that-promote-scientific-temperament.html https://biospectrumindia.com/news/95/11834/oppi-advocates-for-policies-that-promote-scientific-temperament.html Thu, 11 Oct 2018 16:50:00 +0530 The Organisation of Pharmaceutical Producers of India (OPPI) celebrated their 52nd Annual Day recently. Themed #HealthMeetsHope, the Chief Guest of the Annual Day celebrations, Shri. Sidharth Nath Singh, Hon’ble Minister for Health, Govt. of Uttar Pradesh delivered the inaugural address. At the event, he also released OPPI’s annual publication- ‘In Science we trust’. Science continues to transform and inspire humankind and this publication has content curated from across the globe on developments, large and small across a broad spectrum of scientific research that have promoted purpose and wellbeing in the society. Shri Sidharth Nath Singh, Health Minister, Uttar Pradesh appreciated OPPI’s efforts in building the pharma landscape of India.    Speaking about the relevance of the OPPI Annual Day  theme ‘Health Meets Hope’, Singh said it is “relevant” with the  pharma industry delivering "hope" while facilitating ‘health’ remains the responsibility of  Government. He believes that the industry and Government need to collaborate  to deliver a sustainable model of healthcare.   Elaborating on the efforts to improve health outcomes in the state of Uttar Pradesh, Singh mentioned that the state with a population of 23 crore people it recorded a low levels of AMR and  mortality rates- both maternal and infant.     Singh said that the State  is focused on leveraging technology for improving healthcare delivery.   Incentivising the industry through mega pharma parks with fully equipped R&D centres and pathological laboratories, he said, “UP is a land of ‘Unlimited Potential’ so I urge you to come to Uttar Pradesh and enjoy the ease of doing business here.  We have a single window system that allows quick approvals and vlearances.  Above all, we adhere to ethical practices in the best interest of our people."   Speaking on the occasion, A.Vaidheesh, President- OPPI and Vice President, South Asia & Managing Director, GlaxoSmithKline Pharmaceuticals Ltd said, “Millions of patients, over the world are in good health today, because of scientific research that has brought new treatments to them. Discovery of new treatments calls for dedicated commitment from researchers fueled by hope from patients as they battle diseases, both known and unknown. Research in medicine does not end with one discovery it is a series of continuous efforts to better outcomes for patients. As we celebrate the 52nd OPPI Annual Day, we celebrate this very spirit of science as OPPI members are committed to bringing newer treatments for unmet medical needs.” Kanchana TK, Director General, Organisation of Pharmaceutical Producers of India, added, “Our annual publication ‘In Science We Trust’ acknowledges the fact that scientific advancements enable social change and need thoughtful public policies that promote innovation and discovery. Collaborative partnerships between Government, research institutions, the industry and Academia to drive the scientific temperament is required for the progress of mankind.” The event also witnessed the release of the ‘inclUsion’ a compendium of Diversity & Inclusion (D&I) initiatives of OPPI members. Commenting on the release, Kanchana TK continued, “Diversity and inclusion reinforce organizational performance. It needs to be on the dashboard of every business head and not just remain a HR responsibility. OPPI member companies have several initiatives for D&I that makes for an inclusive ecosystem that fosters a more productive and collaborative work environment, in which there are many you’s and one us.” OPPI conferred the OPPI Lifetime Achievement Award 2018 to Dr Abhay and Dr Rani Bang, Indian social activists, and researchers known in the medical fraternity for their ground-breaking research on community health in Gadchiroli district of Maharashtra. OPPI acknowledged the outstanding contribution of scientists towards finding innovative methods for developing a healthier today and tomorrow. Prof Padma Venkitachalam Devarajan (Professor in Pharmacy, Head, Department of Pharmaceutical Sciences and Technology, Institute of Chemical Technology) was awarded the OPPI Scientist award. Dr Sripada S. V. Rama Sastry (Associate Professor, Department of Chemical Sciences, Indian Institute of Science Education and Research, Mohali) was handed over the OPPI Young Scientist award. Dr Indu Pal Kaur (Professor of Pharmaceutics, University Institute of Pharmaceutical Sciences, Punjab University) won the OPPI Women Scientist award. ]]> <![CDATA[USFDA approves Aurobindo Pharma’s Azithromycin to treat infections]]> https://biospectrumindia.com/news/95/11831/usfda-approves-aurobindo-pharmas-azithromycin-to-treat-infections.html https://biospectrumindia.com/news/95/11831/usfda-approves-aurobindo-pharmas-azithromycin-to-treat-infections.html Thu, 11 Oct 2018 15:20:00 +0530 Drug firm Aurobindo Pharma received a final nod from the US health regulator for its Azithromycin Oral suspension used for the treatment of infections. The company has received final approval from the US Food and Drug Administration (USFDA) to manufacture and market Azithromycin Oral suspension 100 mg /5 mL and 200 mg/5 mL.  The product is a generic version of Pfizer Inc's Zithromax oral suspension. "The product will be launched in November 2018," Aurobindo Pharma said. Azithromycin oral suspension is indicated for the treatment of patients with mild to moderate infections, it added. According to IQVIA, the approved product has an estimated market size of $ 71 million for the 12 months ending August 2018. The company now has a total of 386 abbreviated new drug application (ANDA) approvals (357 final approvals including 19 from Aurolife Pharma LLC and 29 tentative approvals) from the USFDA, it added.  Aurobindo Pharma manufactures generic pharmaceuticals and active pharmaceutical ingredients. The company's product portfolio is spread over major therapeutic/product areas encompassing Antibiotics, Anti-Retrovirals, CVS, CNS, Gastroenterologicals, Anti-Allergies and Anti-Diabetics. Shares of Aurobindo Pharma were trading at Rs 773.75 per scrip on the BSE, down by 0.58 per cent from its previous close. On the BSE, 86,000 shares were traded in the counter so far compared with average daily volumes of 1.89 lakh shares in the past two weeks On a consolidated basis, Aurobindo Pharma's net profit fell 12.12% to Rs 455.66 crore on 15.48% increase in net sales to Rs 4181.56 crore in Q1 June 2018 over Q1 June 2017.   ]]> <![CDATA[Lilly India enters the autoimmune segment with Olumiant]]> https://biospectrumindia.com/news/95/11828/lilly-india-enters-the-autoimmune-segment-with-olumiant.html https://biospectrumindia.com/news/95/11828/lilly-india-enters-the-autoimmune-segment-with-olumiant.html Wed, 10 Oct 2018 20:45:00 +0530 Eli Lilly and Company (India) Pvt. Ltd. (Lilly India) has announced the launch of Olumiant (baricitinib). This announcement is taking place few days ahead of World Arthritis Day (October 12th) and is marking the company’s entry into the autoimmune segment in India. Olumiant™ (baricitinib) is a once-daily oral medication for the treatment of adults with moderate-to-severe active Rheumatoid Arthritis who have responded inadequately to, or who are intolerant to one or more disease-modifying anti-rheumatic drugs (DMARDs). Olumiant may be used as monotherapy or in combination with methotrexate. Olumiant will be available in India starting October 2018 in 4mg and 2mg dosage forms. Olumiant is approved in more than 50 countries across the world. Despite the multiple options available for Rheumatoid Arthritis, there still exists an unmet need. More than half of the patients with moderate-to-severe Rheumatoid Arthritis do not experience remission through conventional DMARDs. In clinical studies, Olumiant has demonstrated statistically significant improvements in a number of outcome measures including patient reported outcomes at various time points with rapid onset of action and sustained efficacy as well as superiority to standard of care at ACR 20 (American College of Rheumatology) and DAS (Disease Activity Score) 28 at 12 weeks. Luca Visini, Managing Director, Eli Lilly and Company India said, “Few days ahead of World Arthritis Day, Lilly India is excited to announce the introduction of its innovative therapy for patients living with Rheumatoid Arthritis. It is an announcement that builds on our heritage and commitment to India, a 25 years strong legacy of making life better and addressing the unmet needs of patients living with chronic diseases.” He added, “People with Rheumatoid Arthritis continue to struggle with the debilitating effects of the disease, endure pain and do not achieve disease management goals. This can lead to longterm joint damage and even disability. Olumiant is an effective, advanced once-daily oral treatment option for people suffering from Rheumatoid Arthritis who have not responded well to conventional DMARDs. In clinical trials, Olumiant has proven efficacy and demonstrated rapid and significant improvement in patient related outcomes such as pain, fatigue and joint stiffness. It is important for patients with Rheumatoid Arthritis to have multiple treatment options available to best suit their disease characteristics and experience.” ]]> <![CDATA[MedinCell lists on Euronext Paris, raises €30M]]> https://biospectrumindia.com/news/95/11826/medincell-lists-on-euronext-paris-raises-30m.html https://biospectrumindia.com/news/95/11826/medincell-lists-on-euronext-paris-raises-30m.html Wed, 10 Oct 2018 16:50:00 +0530 Euronext welcomed MedinCell, a Pharma tech company that develops injectable drug delivery solutions, to listing in compartment C of Euronext Paris. MedinCell is hoping to improve patient compliance with medication regimes by injecting them with a drug-infused gel. Patient compliance with taking medication can be as low as 30% and non-compliance is costly for healthcare systems. The French company’s tech, called BEPO, consists of a gel with which it can mix drugs already on the market. Once injected into patients, the drug-infused gel degrades and releases the drug automatically for up to a year. According to the company, you can fine tune how quickly the drug is released just by altering the gel’s ingredients. MedinCell’s lead project is being tested in a US Phase III trial for the treatment of schizophrenia. In partnership with Teva, the biotech combined its BEPO tech to allow the slow release of the antipsychotic risperidone. The biotech is also running a Phase II trial in the US for treating postoperative pain and inflammation. For this trial, it partnered up with the orthopedic surgery company AIC to test BEPO with the anti-inflammatory drug celecoxib. In addition to its IPO, Medincell received a €20M loan from the European Investment Bank in March this year. With the funding, the company plans to develop and expand its portfolio. Other companies in Europe are also injecting cash into slow-release technology. Danish biotech Ascendis hopes to achieve the slow release of hormones such as growth hormone by injecting them with protective carrier molecules. Ascendis aims to reduce the frequency that patients need growth hormone injections and is testing this lead application in a Phase III trial. ]]> <![CDATA[Dr Reddy launches cholesterol-lowering medicine in US market]]> https://biospectrumindia.com/news/95/11825/dr-reddy-launches-cholesterol-lowering-medicine-in-us-market.html https://biospectrumindia.com/news/95/11825/dr-reddy-launches-cholesterol-lowering-medicine-in-us-market.html Wed, 10 Oct 2018 13:15:00 +0530 Dr Reddy’s Laboratories Ltd. has announced the launch of a cholesterol-lowering medication Colesevelam HCl Tablets in the United States market approved by the US Food and Drug Administration (USFDA). The Colesevelam HCI tablet is a generic version of Japanese pharmaceutical company Daiichi Sankyo's Welchol. The WELCHOL brand and generic had an US sale of approximately $ 471 million for the most recent twelve months ending in August 2018 according to IMS Health. The tablets will be available in 625 mg with 180-count bottle size, Dr Reddy's said in a statement. After the launching Shares of Dr Reddy's Laboratories climbed about 1 percent in early trade. Shares of the company hit an intraday high of Rs 2,600 on BSE, up as much as 6.3 percent. ]]> <![CDATA[LANXESS India bags two awards for Sustainable practices, CSR initiatives]]> https://biospectrumindia.com/news/95/11824/lanxess-india-bags-two-awards-for-sustainable-practices-csr-initiatives.html https://biospectrumindia.com/news/95/11824/lanxess-india-bags-two-awards-for-sustainable-practices-csr-initiatives.html Wed, 10 Oct 2018 12:50:00 +0530 LANXESS India Private Limited, the leading specialty chemicals company has been acknowledged for its diligent adherence towards sustainable practices and concerted efforts in the field of corporate social responsibility (CSR), and has been conferred with the Indo-German Chamber of Commerce (IGCC) Award for ‘Outstanding Contribution towards best Sustainable Business Practices by a Large Enterprise’ for the year 2018 and the Indian Chemical Council (ICC) Award 2017 Certificate of Merit for Social Responsibility. Both the awards were presented to LANXESS at different events held in Mumbai towards the end of September after a detailed study by eminent juries constituted by the organizing committees of both the organizations. Namitesh Roy Choudhary, Vice President, PTSE, LANXESS India, received the IGCC Award for Sustainable practices on behalf of LANXESS at the Taj Hotel, Mumbai on 20th September. The award came on the back of the organization’s specific processes and systems to ensure that it follows social and environmental policies in the supply chain and conforms to all standards. Having invested a sizeable amount in India over the years in greenfield investments, acquisitions and in upgradation of assets, LANXESS has been a founder member of Together for Sustainability (TfS) initiative, which is a joint initiative of chemical companies that focuses on the promotion of sustainability practices in the chemical industry's supply chain around a single standard of auditing and assessment. LANXESS’ sites focus on optimal use of natural resources ensuring minimum impact on the environment. At its Jhagadia site, LANXESS has spent 20 percent of total building cost on sustainability projects like Effluent treatment plant, Sewage treatment plant, Multi-fuel boiler, Off-gas Incinerator and creating a Green zone. Similarly, the Nagda site has Co-generation plant, Waste water treatment, Sewage treatment plant, Waste water post treatment plant and Off-gas Incinerator. Further, to significantly reduce Carbon foot-print, 96% of Jhagadia’s and 60% of Nagda’s export consignments have been shifted from road to railways. The ICC Award 2017 Certificate of Merit for Social Responsibility was presented to LANXESS India on the 27th September in Mumbai and was received by Mr. Neelanjan Banerjee, Vice Chairman and Managing Director, LANXESS India and Mr. Sunder Rajan, Head – CSR, LANXESS India. The organization initiated and completed twelve unique CSR projects across locations in the country in 2017. This included projects like Teach for India, empowering municipal school with digital classrooms, infrastructure development of municipal schools, sanitation & hygiene camps for working women from slums in Thane, upgrading healthcare facilities in Nagda Municipal Hospital by way of installing a sonography machine, maintenance of overhead water tank in Nagda supplying water to the local population and installing solar street lamps among others. LANXESS has always selected CSR projects through a bottom-up approach, wherein the needs of the communities are identified after discussions with the local authorities and other stakeholders. The corporate philosophy of the organization in the context of its Social Responsibility initiatives has firmly been “To give back to society a part of its success”. On the receipt of the two awards Mr. Banerjee said, “LANXESS is a good example of creating a long-term vision to develop our business while keeping our commitment to sustainable practices and giving back to society a part of our success.” ]]> <![CDATA[Armas, Shilpa ink distribution pact for oncology products]]> https://biospectrumindia.com/news/95/11818/armas-shilpa-ink-distribution-pact-for-oncology-products.html https://biospectrumindia.com/news/95/11818/armas-shilpa-ink-distribution-pact-for-oncology-products.html Tue, 09 Oct 2018 19:40:00 +0530 Armas Pharmaceuticals Inc., a NJ based pharmaceutical marketing & distribution corporation, and Shilpa Medicare Limited, a Karnataka based pharmaceutical company, have announced a distribution partnership agreement. This agreement will encompass various generic oncology injectables and orals within the U.S. market. The first product, an oncology injectable, to be introduced in late October 2018, has an approximate market size of $116 million annually. Armas expects to launch additional oncology products through the 1st quarter of 2019, with a market size totaling more than $430 million annually. “We are extremely pleased to have an opportunity to partner with Shilpa Medicare Limited, to provide to the US market quality oncology products. Our highly skilled team also looks forward to identifying products for development, utilizing alternative dosage forms, and delivery methods to improve the patient experience.”, says John Niemi, President & CEO of Armas. “We are very excited about this partnership. The combination of Armas’ deep customer experience and Shilpa’s vertical integration, high quality development and manufacturing capabilities are well suited to launch our portfolio of products approved and under FDA review while providing affordable medicines to patients”, says Adam Levitt, CEO of Shilpa North America. ]]> <![CDATA[Lupin announces skin ointment launch in the US]]> https://biospectrumindia.com/news/95/11817/lupin-announces-skin-ointment-launch-in-the-us.html https://biospectrumindia.com/news/95/11817/lupin-announces-skin-ointment-launch-in-the-us.html Tue, 09 Oct 2018 19:30:00 +0530 Pharma major Lupin has announced the launch of Clobetasol Propionate Ointment USP 0.05%, having received an approval from the United States Food and Drug Administration (FDA) earlier. Lupin’s Clobetasol Propionate Ointment USP, 0.05% is the generic equivalent of Fougera Pharmaceuticals Inc.’s Temovate Ointment, 0.05%. It is a super-high potency corticosteroid indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Clobetasol Propionate Ointment USP 0.05% had annual sales of approximately $ 93.4 million in the US. ]]> <![CDATA[Zydus receives final approval for Exemestane Tablets]]> https://biospectrumindia.com/news/95/11801/zydus-receives-final-approval-for-exemestane-tablets.html https://biospectrumindia.com/news/95/11801/zydus-receives-final-approval-for-exemestane-tablets.html Fri, 05 Oct 2018 18:05:00 +0530 Zydus Cadila has received the final approval from the USFDA to market Exemestane Tablets, (US RLD – AROMASIN Tablets), 25 mg. It will be manufactured at the group’s formulations manufacturing facility at SEZ, Ahmedabad. The estimated sale for Exemestane Tablets is $68.6 million (Source: IMS Health, IMS National Sales Perspective Audit, MAT August 2018, extracted September 2018.) Exemestane belongs to the group of medicines called aromatase inhibitor. It is used in women after menopause for the treatment of early breast cancer in women who have cancer that needs the female hormone estrogen to grow, have had other treatments for breast cancer for 2-3 years and are switching to Exemestane to complete 5 years in a row of hormonal therapy. It is also used in the treatment of advanced breast cancer after treatment with other therapies, where it has not benefitted the patient or is no longer effective. The group now has 220 approvals and has so far filed over 330 ANDAs since the commencement of the filing process in FY 2003-04. ]]> <![CDATA[Piramal Pharma introduces Xcelerate Integrated Solutions]]> https://biospectrumindia.com/news/95/11800/piramal-pharma-introduces-xcelerate-integrated-solutions.html https://biospectrumindia.com/news/95/11800/piramal-pharma-introduces-xcelerate-integrated-solutions.html Fri, 05 Oct 2018 18:00:00 +0530 Piramal Pharma Solutions (PPS), a global leader in Contract Development and Manufacturing Solutions, announced the launch of its Xcelerate Integrated Solutions platform to address a rapidly growing market need. This platform will serve the increasing demand from pharmaceutical firms, both large and small, for preferred partnerships with organizations that can provide world-class solutions across a range of verticals - drug discovery, drug substance, drug product, and clinical trial services. Rationalization, restructuring initiatives, and consolidation among customers, combined with an increasing interest in virtualization have led to externalization of clinical program development as a preferred option. Recently, as Contract Manufacturing Organizations have developed scale and expertise across multiple verticals, customers have begun to consider 'program based outsourcing' for better efficiency on time, costs, and management. Xcelerate Integrated Solutions stands out for its flexibility and versatility. For example, the extensive network of PPS sites across the globe allows customers to launch local - irrespective of whether it is North America, Europe, or Asia. The Xcelerate platform provides integrated solutions for orphan diseases, niche therapies, and fast track medicines, where the volume requirements are small, while also having the capacity and track record to address large volume needs of metabolic diseases and neuroscience therapies. The distinct footprint of PPS, with around half its sites in the East and the other half in the West, allows customers to manufacture the final API or Drug product out of the West, while back integrating into starting materials and intermediates out of its sites in the East. ]]> <![CDATA[Dr Reddy's sells Cloderm cream rights to EPI Health]]> https://biospectrumindia.com/news/95/11784/dr-reddys-sells-cloderm-cream-rights-to-epi-health.html https://biospectrumindia.com/news/95/11784/dr-reddys-sells-cloderm-cream-rights-to-epi-health.html Wed, 03 Oct 2018 11:25:00 +0530 Dr. Reddy’s Laboratories Ltd. recently announced that it’s wholly owned subsidiary Promius Pharma, LLC, has sold its rights of Cloderm (clocortolone pivalate) Cream, 0.1% and its authorized generic to EPI Health, LLC, an affiliate of EPI Group, LLC. Under the terms of the agreement, Promius Pharma is eligible to receive an upfront payment followed by future royalties as the consideration for Cloderm Cream and its authorized generic in the United States, effective immediately. “We look forward to EPI continuing to support Cloderm, a brand that providers have prescribed for several decades and find as an important treatment option for their patients.” says Anil Namboodiripad, Ph.D., Senior Vice President, Proprietary Products, and President, Promius Pharma. Ron Owens, President of EPI Health, said, "We are very pleased to have completed this agreement with Dr. Reddy’s to acquire Cloderm® Cream in the United States.  Cloderm® Cream, and its authorized generic, are widely recognized and time-tested among the dermatology community. The addition of this product to our growing portfolio will support our ongoing efforts to build a successful prescription branded franchise in the United States while contributing to EPI Health’s goal of becoming a leader in medical dermatology." ]]> <![CDATA[Lupin, Lilly partner for innovative diabetes treatment in India]]> https://biospectrumindia.com/news/95/11781/lupin-lilly-partner-for-innovative-diabetes-treatment-in-india.html https://biospectrumindia.com/news/95/11781/lupin-lilly-partner-for-innovative-diabetes-treatment-in-india.html Wed, 03 Oct 2018 10:15:00 +0530 Pharma Major Lupin Limited and Eli Lilly and Company (India) Pvt. Ltd., have announced the expansion of their business partnership aimed at widening access to innovative diabetes medicines in India. Under the new partnership, Lupin will distribute and market Lilly’s Aplevant (dulaglutide), a once-weekly injection for type 2 diabetes treatment. Aplevant (dulaglutide) is a once-weekly injectable solution for adults with type 2 diabetes mellitus. Lupin expects to make Aplevant available in India in October 2018. This announcement builds on the Lupin and Lilly India business partnership initiated in 2011 to expand the promotion and distribution of Lilly’s diabetes portfolio in India where Lupin has a large network. Rajeev Sibal, President – India Region Formulations, Lupin said, “Our long-standing partnership with Lilly has enabled us to emerge as a strong contender in the diabetes treatment arena. Lupin is the fastest growing company in the Indian diabetes market and is now ranked as the third largest company in the Anti-diabetes market in India on a MAT basis as of August 2018*. With this new partnership, we are expanding our diabetes portfolio to include a once-weekly diabetes treatment, and improving access to innovative medications for better diabetic care in India. We are delighted to partner with Lilly India and hope to continue building our product pipeline through strategic tie-ups for innovative healthcare solutions for patients and healthcare practitioners in India.” Luca Visini, Managing Director, Lilly India said, “Lilly's heritage in diabetes spans from the first commercial release of insulin in 1923, to leading scientific discoveries of today. Since 1923, we have continuously strived to innovate to meet the diverse needs of people living with diabetes offering a wide portfolio of treatments among which include the first biosynthetic 'human' insulin with recombinant DNA technology, the first rapid insulin analog, and a once weekly non-insulin injection for type 2 diabetes. Building on this strong heritage and legacy in the diabetes field, and our commitment to make life better for all those living with diabetes in India, we are thrilled to work with Lupin to make our innovative therapies and solutions available to the large number of healthcare professionals and patients who need them.”   ]]> <![CDATA[Rotavirus vaccine options expand with WHO prequalification]]> https://biospectrumindia.com/news/95/11764/rotavirus-vaccine-options-expand-with-who-prequalification.html https://biospectrumindia.com/news/95/11764/rotavirus-vaccine-options-expand-with-who-prequalification.html Fri, 28 Sep 2018 11:15:00 +0530 PATH welcomes the World Health Organization's (WHO's) prequalification of the thermostable rotavirus vaccine, ROTASIIL, manufactured by Serum Institute of India. The vaccine, which prevents severe rotavirus-induced diarrhea in infants, provides an innovative and affordable option to the global market as it is the first rotavirus vaccine that does not require constant refrigeration and will help meet the critical public health goal of improving vaccine supply worldwide. Achieving WHO prequalification means that ROTASIIL will now be available for procurement by United Nations agencies and Gavi, the Vaccine Alliance, for use in low- and middle-income countries. This will help accelerate availability of the vaccine in countries experiencing the highest burden of rotavirus-induced diarrhea by providing a practical and affordable option for vaccine introduction. Rotavirus is the most common cause of severe diarrheal disease in children worldwide, and vaccination is the best way to prevent severe rotavirus illness. According to a recent study, 37 percent of global childhood diarrheal deaths in 2013 were due to rotavirus, a total of 215,000 rotavirus deaths. More than 90 percent of these deaths occurred in low-resource settings. ROTASIIL was licensed by the Drugs Controller General of India in January 2017. Subsequently, data analysis from a Phase 3 study that gathered additional information required for WHO prequalification was completed and submitted in September 2017. The study found no interference with the immune response to childhood vaccines when co-administered with ROTASIIL and confirmed the consistency of three different and independent lots of the vaccine produced by Serum Institute. India began using ROTASIIL in its national immunization program starting in April 2018 in Jharkhand state, with further roll-out expected. ROTASIIL is also currently available for sale in India's private market. The international nonprofit PATH partnered with Serum Institute on evaluating ROTASIIL in the Phase 3 studies conducted in India and assisted with their applications for local licensure and WHO prequalification. PATH is continuing to work with Serum Institute on additional studies on ROTASIIL effectiveness (disease reduction in the population) and cost-effectiveness of the vaccine in India. "PATH congratulates our partner, Serum Institute of India, for achieving the critical milestone for global access, WHO prequalification, of their oral rotavirus vaccine, ROTASIIL. PATH looks forward to contributing to the ongoing evaluation of this vaccine, and seeing a thermostable product added to the global supply of rotavirus vaccines in the fight against diarrheal disease," said Dr. David C. Kaslow, PATH's vice president for Essential Medicines and global head of the Center for Vaccine Innovation and Access. Médecins Sans Frontières and Epicentre also evaluated the efficacy and safety of ROTASIIL in a separate Phase 3 study in Niger. The ROTASIIL used in the Niger study was stored at less than 25°C and transported for vaccination at ambient temperature, thus bypassing the typically challenging and costly cold-chain requirements that apply to most other vaccines. These data were included in the WHO prequalification dossier that led to the approval of the vaccine as a thermostable product. ROTASIIL is an oral vaccine administered to infants in a three-dose course at 6, 10, and 14 weeks of age, at the same time as routine vaccinations. The WHO-prequalified ROTASIIL formulation is a lyophilized (freeze-dried) presentation packaged in single-dose vials alongside a diluent. ROTASIIL contains bovine-human reassortant rotaviruses against the most common rotavirus serotypes (G1, G2, G3, G4, and G9). The bovine-human reassortant rotaviruses were developed by the US National Institutes of Health and licensed to several emerging-country manufacturers and one US company for further development. Serum Institute was one of the licensees and developed it as ROTASIIL, a pentavalent (five-strain) vaccine product. ]]> <![CDATA[AstraZeneca receives European marketing authorisation for Imfinzi]]> https://biospectrumindia.com/news/95/11742/astrazeneca-receives-european-marketing-authorisation-for-imfinzi.html https://biospectrumindia.com/news/95/11742/astrazeneca-receives-european-marketing-authorisation-for-imfinzi.html Tue, 25 Sep 2018 15:00:00 +0530 AstraZeneca and MedImmune, its global biologics research and development arm, have announced that the European Commission has granted marketing authorisation for Imfinzi (durvalumab) as monotherapy for the treatment of locally-advanced, unresectable non-small cell lung cancer (NSCLC) in adults whose tumours express PD-L1 on ≥1% of tumour cells and whose disease has not progressed following platinum-based chemotherapy and radiation therapy (CRT). The approval is based on results from the Phase III PACIFIC trial. Dave Fredrickson, Executive Vice President, Head of the Oncology Business, said: “Patients in Europe diagnosed with locally-advanced, unresectable non-small cell lung cancer now have a new treatment option. Imfinzi is the only immunotherapy to be approved in this curative-intent setting, and we are proud to bring a new standard of care for this difficult disease.” Dr. Luis Paz-Ares, co-principal investigator of the PACIFIC trial, from the Hospital Universitario Doce de Octubre, Madrid, Spain, said: “Lung cancer is the leading cause of cancer-related death in Europe and approximately a third of European patients with NSCLC present with locally-advanced disease. For decades, the standard of care for these patients has been chemotherapy and radiation therapy followed by active surveillance, after which the majority of patients progress to advanced disease. Imfinzi has demonstrated a compelling survival benefit for these patients in this area of significant unmet need.” ]]> <![CDATA[Accord Healthcare recalls diuretics due to labelling mix up]]> https://biospectrumindia.com/news/95/11732/accord-healthcare-recalls-diuretics-due-to-labelling-mix-up.html https://biospectrumindia.com/news/95/11732/accord-healthcare-recalls-diuretics-due-to-labelling-mix-up.html Mon, 24 Sep 2018 11:25:00 +0530 Accord Healthcare Inc, the US arm of Intas Pharmaceuticals, is recalling over 46,000 bottles of Hydrochlorothiazide tablets manufactured by the Ahmedabad-based firm, on account of labelling mix-up, USFDA said. Hydrochlorothiazide tablets belong to a class of drugs known as diuretics and are used for treatment of high blood pressure and edema. Accord Healthcare is recalling 46,632 bottles of Hydrochlorothiazide tablets USP in the strength of 12.5 mg, the Enforcement Report by United States Food and Drug Administration (USFDA) said. The reason for the recall is "Labelling: label mix-up: customer complaint that a sealed bottle labelled as Hydrochlorothiazide tablets USP 12.5 mg contained only Spironolactone tablets USP 25 mg," it added. The voluntary nationwide recall in the US and Puerto Rico has not been classified yet, the report said. ]]> <![CDATA[Biocon, Mylan announce positive CHMP opinion for Fulphila]]> https://biospectrumindia.com/news/95/11731/biocon-mylan-announce-positive-chmp-opinion-for-fulphila.html https://biospectrumindia.com/news/95/11731/biocon-mylan-announce-positive-chmp-opinion-for-fulphila.html Mon, 24 Sep 2018 11:05:00 +0530 Biocon Ltd. and Mylan N.V. has announced that the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending approval of Fulphila, a biosimilar to Amgen’s Neulasta (pegfilgrastim). The CHMP positive opinion is based upon a review of evidence demonstrating biosimilarity. Data submitted as part of the Marketing Authorization Application included similarity assessment in analytical testing, preclinical and clinical studies that demonstrated biosimilarity to the reference product, Neulasta. The Phase I program in healthy volunteers and Phase III clinical study conducted in breast cancer patients receiving adjuvant and neoadjuvant chemotherapy, demonstrated no clinically meaningful differences in terms of pharmacokinetics, pharmacodynamics, safety, efficacy and immunogenicity compared to Neulasta. The CHMP positive opinion will now be considered by the European Commission. The decision on approval is expected by November 2018. Fulphila was approved by the U.S. Food and Drug Administration (FDA) earlier this year and is the first FDA-approved biosimilar for Neulasta in the U.S. Regulatory applications for Fulphila also have been submitted in Australia, New Zealand, Canada and several other countries. Biocon CEO & Joint Managing Director, Dr. Arun Chandavarkar, said: "CHMP's decision to recommend approval of Biocon and Mylan's biosimilar Pegfilgrastim brings us a step closer to offer this high quality, affordable biologic therapy for cancer patients in the EU, having launched this product in the US, earlier this year. It is an outcome of our commitment to enhance access for patients and be a leading global biosimilars player on the back of significant investments in R&D and global scale manufacturing, together with our partner Mylan.” Mylan President Rajiv Malik commented: “We are very proud to be a leader in bringing the first wave of biosimilars to the European market and driving greater access to more affordable treatment options for patients living with chronic and life-threatening illness such as cancer. Receiving CHMP positive opinion for our pegfilgrastim biosimilar, Fulphila, is a key milestone in this journey, demonstrating our commitment to patient and healthcare communities across Europe and the strength of our collaboration with Biocon.” ]]> <![CDATA[Almirall gets EC approval for psoriasis drug]]> https://biospectrumindia.com/news/95/11713/almirall-gets-ec-approval-for-psoriasis-drug.html https://biospectrumindia.com/news/95/11713/almirall-gets-ec-approval-for-psoriasis-drug.html Thu, 20 Sep 2018 12:00:00 +0530 Sun Pharma has said that Spanish firm Almirall has received approval from the European Commission (EC) for Ilumetri, a drug used for treating psoriasis. In July 2016, Sun Pharma out-licensed Ilumetri (tildrakizumab) to Almirall, for the development and commercialisation of the product in Europe. "As indicated by Almirall, rollout of Ilumetri in Europe will start in the next few weeks," Sun Pharma said in a statement. Psoriasis is a chronic immune disease that appears on the skin. It affects an estimated 7.8 million adults in Europe and around 125 million people worldwide.     ]]> <![CDATA[Strides Shasun receives USFDA observations for Bengaluru unit]]> https://biospectrumindia.com/news/95/11712/strides-shasun-receives-usfda-observations-for-bengaluru-unit.html https://biospectrumindia.com/news/95/11712/strides-shasun-receives-usfda-observations-for-bengaluru-unit.html Thu, 20 Sep 2018 11:50:00 +0530 Strides Pharma Science has received three observations from the USFDA after the inspection of its formulations facility in Bengaluru. “The formulations facility in Bangalore recently underwent pre-approval product inspection by the US Food and Drug Administration (USFDA). The inspection had ended on August 25, 2018 and the company has been issued Form 483 with 3 observations,” Strides Pharma Science has said in a regulatory filing. The company believes that the observations are not material in nature and it has already responded to the USFDA. It has recently received a product approval for potassium chloride extended release tablets from the facility. As per the USFDA, Form 483 is issued to a firm management at the conclusion of an inspection when an investigator (s) has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts. ]]> <![CDATA[Mylan Hackathon 2018 to ‘Connect, Collaborate and Innovate’]]> https://biospectrumindia.com/news/95/11705/mylan-hackathon-2018-to-connect-collaborate-and-innovate.html https://biospectrumindia.com/news/95/11705/mylan-hackathon-2018-to-connect-collaborate-and-innovate.html Wed, 19 Sep 2018 11:30:00 +0530 Mylan, a global pharmaceutical company is hosting the 2018 Mylan Hackathon at its Global Centre in Bengaluru on October 13-14, 2018. The event will focus on creating innovative solutions in the healthcare segment for patients, payers, providers and other healthcare professionals. This is a unique opportunity for students and professionals to connect, collaborate and innovate to come up with solutions that address real-world challenges in the healthcare industry. Teams consisting of students, engineers, developers, designers, analysts, tinkerers, mavens, game-changers and Mylan employees will compete for the first prize of Rs 100000 and a second prize of Rs 50000. Top notch giveaways, spot quizzes and free refreshments will add to the excitement. Date: Saturday October 13th and Sunday October 14th, 2018 Venue: Mylan, Platina-3, Prestige Technology Park, Marathahalli Outer Ring Road, Bangalore – 560103 Registrations: Individuals can register themselves and get more information on the challenge at https://www.mylanhackathon.com ]]> <![CDATA[Aurobindo Pharma gets SA health authority nod for HIV drug ]]> https://biospectrumindia.com/news/95/11700/aurobindo-pharma-gets-sa-health-authority-nod-for-hiv-drug-.html https://biospectrumindia.com/news/95/11700/aurobindo-pharma-gets-sa-health-authority-nod-for-hiv-drug-.html Tue, 18 Sep 2018 15:45:00 +0530 Aurobindo Pharma has received approval from the South African Health Products Regulatory Authority (SAHPRA) for its Dolutegravir, Lamivudine and Tenofovir Disoproxil Fumarate (DLT) tablets, 50mg/300mg/300mg, the first-line preferred regimen for HIV patients as per latest WHO guidelines. Aurobindo is now among the first few companies which have received approval for this product. This approval demonstrates our commitment towards HIV patients and enables the company to participate in South African HIV tender as well as launch in private market. The approval further strengthens Aurobindo's HIV product basket in South Africa, which has the potential to improve the lives of millions of patients, as per BSE filing.  Prior to SAHPRA's approval, Aurobindo has received tentative approval for the drug from USFDA and launched in Sub-Saharan African markets as part of its commitment to bring affordable HIV drugs to millions of patients globally. ]]> <![CDATA[Glenmark gets USFDA approval for menopause symptom relief drug]]> https://biospectrumindia.com/news/95/11691/glenmark-gets-usfda-approval-for-menopause-symptom-relief-drug.html https://biospectrumindia.com/news/95/11691/glenmark-gets-usfda-approval-for-menopause-symptom-relief-drug.html Mon, 17 Sep 2018 18:10:00 +0530 Glenmark Pharmaceuticals has received final approval from the US health regulator for a generic version of Nordisk Inc's VAGIFEM, used for providing relief from menopause symptom. Glenmark Pharmaceuticals Inc., USA has been granted final approval by the United States Food and Drug Administration (USFDA) for Estradiol Vaginal Inserts USP, 10 mcg. The approved product is a generic version of Novo Nordisk Inc's VAGIFEM. Quoting IQVIA sales data for the 12 month period ending July 2018, Glenmark said VAGIFEM, 10 mcg, market achieved annual sales of approximately $286.3 million. The company's current portfolio consists of 139 products authorised for distribution at the US marketplace and 61 abbreviated new drug applications (ANDAs) pending approval with the USFDA.   ]]> <![CDATA[German firm MANN+HUMMEL launches ‘OurAir’ in the Indian market]]> https://biospectrumindia.com/news/95/11690/german-firm-mannhummel-launches-ourair-in-the-indian-market.html https://biospectrumindia.com/news/95/11690/german-firm-mannhummel-launches-ourair-in-the-indian-market.html Mon, 17 Sep 2018 16:40:00 +0530 Germany based MANN+HUMMEL Group, a leading global filtration specialist with revenues of 4 Billion Euro and 20,000 employees at 80 locations worldwide, has announced the launch of its OurAir brand in the Indian market.   OurAir offers end-to-end indoor air quality solutions that combine MANN+HUMMEL’s 77 years of filtration expertise with cutting-edge digital innovation. These solutions are based on smart devices, where air quality monitors, filters, purification and ventilation systems, integrate seamlessly with the OurAir digital platform.   With OurAir solutions, building owners, facility managers and tenants can “KNOW, IMPROVE and MANAGE” the air quality in commercial buildings.   The launch in India also coincided with the official announcement of the accreditation of both the OurAir air quality monitors and digital platform by RESET, the world’s first sensor-based and performance-driven building standard and certification program. The RESET Standard is created with the aim of improving indoor environments and occupant health on a global scale.   OurAir is the first company to successfully achieve RESET accreditation for both its cloud software (OurAir Digital Platform), and air quality monitors (OurAir SPS208, SPB308, and SPB358), making it the largest complete end-to-end solution provider in the world.   “Access to clean air is vital for human health and well-being. Unfortunately air pollution in India continues to pose a serious challenge. Based on a WHO ranking of particulate pollution in cities in 2018, 14 of the 20 cities with the highest levels are located in our country.” said Pradeep Randhawa, Managing Director, MANN+HUMMEL India. “We are paying a high price for this, where 30% of all premature deaths today are due to air pollution. As a company MANN+HUMMEL wants to contribute. While it is challenging to eliminate outdoor air pollution, there are effective solutions to ensure good air quality indoors, where we spend up to 90% of our time.”   “The launch of OurAir in India is timely. There is an increase in public awareness, growing demand for pollution-free offices and homes, and new government regulations and building standards supporting the adoption of clean air solutions. We expect the market to grow rapidly over the next few years” added Pradeep Randhawa.    To mark the OurAir launch in India, MANN+HUMMEL sponsored the inaugural Air Quality Expert Series in Bangalore. Bringing together thought leaders and representatives from government, industry and trade associations, this event explored trends driving the shift in focus from green to healthy buildings, and how the adoption of new air quality solutions, and building standards such as RESET, are helping to support this shift.  ]]> <![CDATA[Zydus Cadila to bring 50 products in US market]]> https://biospectrumindia.com/news/95/11684/zydus-cadila-to-bring-50-products-in-us-market.html https://biospectrumindia.com/news/95/11684/zydus-cadila-to-bring-50-products-in-us-market.html Mon, 17 Sep 2018 12:45:00 +0530 Zydus Cadila is an innovative, global pharmaceutical company that discovers, develops, manufactures and markets a broad range of healthcare therapies. Ahmedabad-based Cadila Healthcare, on the back of a 64 percent surge in its last financial year’s business in the US, is going strong on boosting its pipeline for the world’s largest single-country drug market. Cadila Healthcare is one such company that can deliver on multiple fronts. Strong domestic presence, growing US pipeline especially in complex generics and biologics, which have high entry barriers and a robust position in high-growth therapeutic areas, including dermatology, pain management, respiratory and cardiology, are positives. The management has guided for 50+ product launches in the US in FY19. Its US pipeline (cumulative) consists of 330 filed ANDAs, and 144 pending final approvals. The company’s shift in focus towards building its specialty pipeline in the US in pain management, dermatology and oncology products should pay off well in one to two years. Cadila Healthcare has at least ten para IV filings for the US. As such, the company aims to launch 50 products in the US during the current fiscal year. Zydus aspires to be a research-based pharmaceutical company by 2020. When an abbreviated new drug application (ANDA) filed with the US Food and Drug Administration (USFDA) contains a paragraph IV certification, the product (when it gets the final approval from the FDA) can be eligible for 180 days of marketing exclusivity. Under paragraph IV, a company can seek FDA approval to market a generic drug before the patent expires. This involves litigation with the patent holder.   ]]> <![CDATA[Alembic Pharma receives approval for diabetes drug]]> https://biospectrumindia.com/news/95/11680/alembic-pharma-receives-approval-for-diabetes-drug.html https://biospectrumindia.com/news/95/11680/alembic-pharma-receives-approval-for-diabetes-drug.html Sun, 16 Sep 2018 22:00:00 +0530 Alembic Pharmaceuticals has said that it has received tentative approval from the US health regulator to market Alogliptin and Metformin Hydrochloride tablets, an anti-diabetes medication, in the US market. The company's product is a generic version of Takeda Pharma USA's Kazano tablets, Alembic Pharmaceuticals said in a regulatory filing. Alogliptin and Metformin Hydrochloride tablets had an estimated market size of USD 22.5 million in the US for 12 months ending December 2017, according to the market data. Alembic now has a total of 77 abbreviated new drug application (ANDA) approvals from the USFDA. ]]> <![CDATA[Mitra Biotech, Glenmark to advance immuno-oncology portfolio]]> https://biospectrumindia.com/news/95/11670/mitra-biotech-glenmark-to-advance-immuno-oncology-portfolio.html https://biospectrumindia.com/news/95/11670/mitra-biotech-glenmark-to-advance-immuno-oncology-portfolio.html Fri, 14 Sep 2018 10:55:00 +0530 Mitra Biotech has announced a partnership with Glenmark Pharmaceuticals focused on advancing Glenmark's proprietary immuno-oncology drug pipeline utilizing Mitra's CANscript platform. CANscript is a human, immune-relevant ex vivo platform that allows drug developers to understand drug performance in human tissue, which in turn allows for an informed approach to clinical development and patient response. CANscript recreates the in vivo tumor microenvironment, maintaining the heterogeneity of the tumor while preserving its immune compartment. This uniquely positions the platform to provide drug developers with answers to mechanistic questions about their immuno-oncology drug candidates and prioritize the most promising candidates for advancement into clinical trials. Glenmark's immuno-oncology pipeline currently includes three bispecific monoclonal antibody (bsAb) candidates being studied in a wide range of tumor types. GBR 1302, a HER2xCD3 bsAb and GBR 1342, a CD38XCD3 bsAb are currently in Phase 1; and GBR 1372, an EGFRxCD3 bsAb, is in preclinical development. ]]> <![CDATA[Kusum Group launches Rs 90 Cr Manufacturing Plant in Indore]]> https://biospectrumindia.com/news/95/11667/kusum-group-launches-rs-90-cr-manufacturing-plant-in-indore.html https://biospectrumindia.com/news/95/11667/kusum-group-launches-rs-90-cr-manufacturing-plant-in-indore.html Wed, 12 Sep 2018 17:20:00 +0530 Pharmaceutical major Kusum Group of Companies has announced the launch of its latest 90 crore Indore plant at the special economic zone in Pithampur. Built on an area of over 4.88 acres, the state-of-the-art Greenfield manufacturing plant is equipped with latest technology and will comply with cGMP (Current Good Manufacturing Practice) PIC/S (Pharmaceutical Inspection Co-operation Scheme) and EU (European Union) quality standards. Presently in its first phase, the plant will be completed in three phases with an investment of additional 120 crores in over 3 years. “We are extremely happy to have launched our 3rd plant in India and 4th overall. The plant has the manufacturing capacity of 390 million units to manufacture different types of tablets, capsules, sachet products and effervescent tablets which require manufacturing condition of 18% to 60% relative humidity. In the first phase, operation in the plant has begun for the filing batches of about 25 products. Upon completion of the two phases, the capacity will increase up to 1550 million units. This is an important milestone in the our growth story as the plant will further boost our national and international expansion plans and will help us serve the needs of newer markets.”, said Mr. Sanjeev Gupta, Managing Director, Kusum Group of Companies. Detailing more about the technology that is powering the plant, Mr. Sanjeev Gupta, said “Our focus has always been on creating export oriented products and to ensure that the best quality standards are adhered to while manufacturing. The plant is equipped with the robust Quality Management System as per the current GMP requirements to ensure that there are proper and consistent controls at each stage of manufacturing to ensure products of consistent quality are manufactured. Our Quality Control laboratory has the latest instruments such as HPCL, GC, UV-Vis spectrophotometer, Polarimeter, FTIR technology, etc.  to control the quality of our products.” While in the first phase, the plant is ready for manufacturing tablets, capsules, Effervescent tablets and products in sachets, in the second phase, the capacity of tablets and sachets will be increased and while in the third Phase, a new manufacturing unit will be set up to manufacture injectable products. With the launch of the 1st phase of the Indore plant, the Kusum Group has created employment opportunities for around 100 jobs. The plant will further help the company gain more grounds in the Indian market share and will support the distribution network of south Indian markets.    ]]> <![CDATA[Zydus receives USFDA nod for diabetes drug]]> https://biospectrumindia.com/news/95/11656/zydus-receives-usfda-nod-for-diabetes-drug.html https://biospectrumindia.com/news/95/11656/zydus-receives-usfda-nod-for-diabetes-drug.html Tue, 11 Sep 2018 13:10:00 +0530 Zydus Cadila is an innovative, global pharmaceutical company that discovers, develops, manufactures and markets a broad range of healthcare therapies. The company has received the tentative approval from the USFDA for Sitagliptin Tablets USP,25 mg, 50 mg, and 100 mg indicated for treating diabetes, in the American market. It will be manufactured at the group’s formulations manufacturing facility at SEZ, Ahmedabad. Sitagliptin is used along with diet and exercise and sometimes with other medications to lower blood sugar levels in patients with type 2 diabetes (condition in which blood sugar is too high because the body does not produce or use insulin normally). Sitagliptin is in a class of medications called dipeptidyl peptidase—4 (DPP-4) inhibitors. It works by increasing the amounts of certain natural substances that lower blood sugar when it is high. The group has more than 217 approvals, and so far filed over 330 abbreviated new drug applications (ANDAs). ]]> <![CDATA[Glenmark to market Fluticasone DPI in Germany ]]> https://biospectrumindia.com/news/95/11645/glenmark-to-market-fluticasone-dpi-in-germany-.html https://biospectrumindia.com/news/95/11645/glenmark-to-market-fluticasone-dpi-in-germany-.html Mon, 10 Sep 2018 13:25:00 +0530 Glenmark Pharmaceuticals Ltd., a research-led global integrated pharmaceutical company announced that its subsidiary Glenmark Arzneimittel GmbH has secured marketing authorization in Germany for Fluticasone/Salmeterol Dry Powder Inhaler (DPI), a generic version of GlaxoSmithKline's Seretide® Accuhaler®. Fluticasone/Salmeterol DPI is a combination product for the treatment of asthma and chronic obstructive pulmonary disease (COPD). Glenmark will sell the product in Germany under the name 'SALFLUTIN'. Glenmark had entered into a strategic development and licensing agreement with Celon Pharma S.A. (Celon) in 2015 to develop and market generic Fluticasone/Salmeterol DPI in 15 European countries. The company has already launched this product in Denmark, Sweden and Norway. According to IQVIA data, Fluticasone/Salmeterol Dry Powder Inhaler (DPI) had sales of USD 844 million in Europe in the 12 month period ended March 2018. ]]> <![CDATA[Lupin to create skilled job-ready graduates by 2020]]> https://biospectrumindia.com/news/95/11634/lupin-to-create-skilled-job-ready-graduates-by-2020.html https://biospectrumindia.com/news/95/11634/lupin-to-create-skilled-job-ready-graduates-by-2020.html Fri, 07 Sep 2018 11:55:00 +0530 Under the Learn and Earn Initiative, Lupin Pharma expecting to train more than 1000 under graduates into pharma professionals by the year 2020. Lupin has launched its Learn and Earn initiative in which candidate who has passed Standard 12 in the science stream with a minimum of 50 percent marks but are facing financial constraints are taken for three-year-long course during which they are paid stipend and provided all the facilities. The company has initiated the Learn and Earn Initiative at its facilities in Goa, Tarapur (Maharashtra), Indore (MP), Aurangabad (Maharashtra) and Sikkim, he said. During the course period, the candidate undergoes five days on-the-job training with one day of classroom session. Further, the students have to compulsorily work with Lupin for two years, after completing their course before they have their options open to join any other pharmaceutical firm. Mumbai-headquartered Lupin has estimated that by the year 2020 they would be spending almost Rs20 crore on this program. This program will bridge the manpower requirement of pharmaceutical sector in a big way. Yashwant Mahadik, president, global human resource, Lupin said “program was conceptualized in the year 2010 due an acute shortage of skilled manpower. Historically, Lupin was recruiting 1000 plus fresh graduates every year with no relevant job skill, and sensed that there was a need of job-ready graduates with appropriate technical and life skills”. Lupin’s main focus to start this program was to create a ready pool of talent and skilled professionals in Indian pharmaceuticals.   ]]> <![CDATA[Aurobindo Pharma secures Sandoz's biz in US for $900 M]]> https://biospectrumindia.com/news/95/11626/aurobindo-pharma-secures-sandozs-biz-in-us-for-900-m.html https://biospectrumindia.com/news/95/11626/aurobindo-pharma-secures-sandozs-biz-in-us-for-900-m.html Thu, 06 Sep 2018 11:50:00 +0530 Aurobindo Pharmaceuticals has announced the acquisition of Sandoz's generic business in the US for $900 million. The deal gives the Hyderabad based company access to Sandoz's portfolio of oral solids and dermatology drugs and manufacturing footprint and makes it the second largest generic player in the US-based on prescriptions. Aurobindo said the acquisition will be funded through debt but did not disclose further details in an announcement. The acquisition will add approximately 300 products including projects in development as well as commercial and manufacturing capabilities in the US, complementing and expanding the group's portfolio and pipeline. Sandoz's generic portfolio generated sales of $600 million in H1 2018 and is expected to generate a sale of $900 million in one year of completion of an acquisition. With this acquisition, Aurobindo will grow and diversify its business in the US. Acquiring these businesses from Sandoz will allow the company to further expand its product offering and to become a leading player in the generic dermatology market. ]]> <![CDATA[Pharma outlook stable despite intensifying profitability headwinds]]> https://biospectrumindia.com/news/95/11612/pharma-outlook-stable-despite-intensifying-profitability-headwinds.html https://biospectrumindia.com/news/95/11612/pharma-outlook-stable-despite-intensifying-profitability-headwinds.html Tue, 04 Sep 2018 17:25:00 +0530 India Ratings and Research (Ind-Ra) has maintained a stable outlook for the pharmaceutical sector for the rest of FY19. The domestic pharmaceutical market growth is likely to remain robust, largely supported by various measures adopted by the government of India to improve access to medicines. Steady investment in research and development is likely to support companies focused on regulated markets, such as Europe and the US, to sustain healthy product pipelines. Ind-Ra expects the Indian pharmaceutical sector’s operating profitability to remain subdued in FY19 on account of the twin headwinds of input price inflation and elevated pricing erosion in key target markets. The implementation of strict environmental regulations by the Chinese authorities has adversely affected the manufacturers of active pharmaceutical ingredients and intermediates. The Indian pharmaceutical industry is heavily dependent on China for various active pharmaceutical ingredients and key starting materials. Pricing erosion in the US generic drug market continues to remain elevated for most Indian pharmaceutical companies, as the progress made by them to expand their portfolios of difficult-to-manufacture, chemically complex drugs has been slow. Complex generic drugs generally have more defensible margins than immediate-release oral solid dosages. While the measures taken by the US Food and Drug Administration to usher in more clarity on regulatory pathways for the approval of complex generics and address the strategies of large innovator companies to delay the market entry of generic drugs can benefit generic drug makers, the benefits are not likely to be seen in FY19. Consequent to constrained EBITDA generation, operational cash flow generation is likely to soften in FY19 and keep free cash flow generation moderately negative. The sector’s net leverage is likely to deteriorate marginally but it would still remain comfortable at the FY18 level of about 2.0x. ]]> <![CDATA[DiabetOmics set to sprawl in Hyderabad ]]> https://biospectrumindia.com/news/95/11611/diabetomics-set-to-sprawl-in-hyderabad-.html https://biospectrumindia.com/news/95/11611/diabetomics-set-to-sprawl-in-hyderabad-.html Tue, 04 Sep 2018 17:00:00 +0530 US-based DiabetOmics Inc, which has set up a facility to manufacture rapid testing kits (including one for saliva-based diabetes monitoring) on Hyderabad’s outskirts at Mupireddipally in Medak district, is planning to raise about $20 million early next year to fund the commercialisation of its products and expansion of its recently commissioned global facility in Hyderabad. DiabetOmics Inc founder CEO Dr Srinivasa Nagalla said,“We plan to raise $20 million via private placement in the first quarter of 2019 for commercialising the three tests we have developed and expanding our India manufacturing facility to meet the global supply of our products. The full-scale expansion to meet global demand is expected to be completed by 2020”. The company plans to scale up its existing 37,000sft facility by another 20,000sft as part of the second phase. The company, which has developed a rapid test for preeclampsia as part of its maternal health focus as well as a blood test for detecting type-1 diabetes and a saliva-based test for type-II diabetes (1-2 week average blood glucose levels), is also looking at going public in 2020 with a potential $70-80million offering. The medical diagnostics player had, in 2015 and 2016, raised $4.5million from Ventureast and 0.5 million from Shantha Biotech founder Dr KI Varaprasad Reddy, who is also the chairman of DiabetOmics India Pvt Ltd, the Indian arm of DiabetOmics Inc. Talking about the roadmap ahead, Nagalla said the facility has the capacity to manufacture about 1 lakh readers per annum and 5-6 million test strips per annum and will begin introducing them in the Indian market later this month. It will initially target physicians and clinics, NGOs working in the healthcare space as well as government bodies. It will then target pharmacies and look at putting its products in the OTC market over the next 2-3 years. "Government adoption at primary healthcare level will take at least 2-3 years. We are already working with global diabetes organisations like JDRF and Helmsley charitable trust and are also talking to others like the Bill & Melinda Gates Foundation, who are working in the maternal health space," Nagalla said. Exports are also on the cards from the facility from the first half of 2019. It will target neighboring countries, South East Asia as well as Europe and US. “We have got CE approval for Europe and are talking to a few maternal health MNCs there. We hope to begin selling our preeclampsia kits in Europe by the first half of 2019. We have also initiated the process for 510K approval from USFDA, which should take about 6-8 months to come through,” he explained. DiabetOmics is also working on developing an early marker test for diabetic nephropathy, which leads to diabetics losing renal function, and hopes to launch it by 2019 end. “The year 2019 will be our first full year of operations and we hope to break even in 2019-20,” said Nagalla, pointing out that the expansion will hike the capacity of the Hyderabad facility to about 10 million strips per annum. ]]> <![CDATA[Bayer gets FDA Approval for Jivi to treat Hemophilia A]]> https://biospectrumindia.com/news/95/11600/bayer-gets-fda-approval-for-jivi-to-treat-hemophilia-a.html https://biospectrumindia.com/news/95/11600/bayer-gets-fda-approval-for-jivi-to-treat-hemophilia-a.html Mon, 03 Sep 2018 12:35:00 +0530 Bayer announced that the U.S. Food and Drug Administration (FDA) has approved Jivi® (BAY94-9027, antihemophilic factor [recombinant] PEGylated-aucl) for the routine prophylactic treatment of hemophilia A in previously treated adults and adolescents 12 years of age or older. The initial recommended prophylactic regimen for Jivi is twice weekly with the ability to dose every five days and further individually adjust to less or more frequent dosing based on bleeding episodes. The FDA also approved Jivi for on-demand treatment and the perioperative management of bleeding in the same population. This approval is based on results from the Phase 2/3 PROTECT VIII trial, which demonstrated bleed protection and safety of up to a median of 1.9 years (range of 0-2.6 years). Jivi is the third FDA-approved hemophilia A treatment in Bayer's Hematology portfolio. Jivi works by replacing the reduced or missing factor VIII (FVIII) in adults and adolescents 12 years of age or older with hemophilia A. Through its site-specific PEGylation, Jivi has a half-life of 17.9 hours that delivers sustained levels in the blood. Jivi is an important new treatment option in recombinant FVIII (rFVIII) replacement therapy. Recombinant factor VIII is the standard of care for hemophilia A and has proven efficacy and safety established over decades of clinical trials and real-world experience. Treatment with Jivi was well tolerated in the majority of adult and adolescent patients in clinical trials. The most frequently reported adverse reactions in previously treated patients 12 years of age or older were headache, cough, nausea, and fever. A FVIII inhibitor (1.7 BU/mL) was reported in one previously treated adult subject. Repeat testing did not confirm the presence of a FVIII inhibitor. Bayer has also submitted marketing authorization applications for BAY94-9027 for the treatment of hemophilia A in the European Union and Japan. ]]> <![CDATA[Suven secures product patents in China, Eurasia]]> https://biospectrumindia.com/news/95/11586/suven-secures-product-patents-in-china-eurasia.html https://biospectrumindia.com/news/95/11586/suven-secures-product-patents-in-china-eurasia.html Fri, 31 Aug 2018 11:15:00 +0530 Suven Life Sciences has said that it has been granted a product patent each by China and Eurasia corresponding to a new chemical entity (NCE) for the treatment of disorders associated with neurodegenerative diseases. These patents are valid till 2034, the company said in a BSE filing "We are pleased by the grant of these patents to Suven for our pipeline of molecules in the CNS arena, which are being developed for cognitive disorders with high unmet medical needs with a huge market potential globally," Suven Life CEO Venkat Jasti said. The granted claims of the patents are being developed as therapeutic agents useful in the treatment of cognitive impairment associated with neurodegenerative disorders like Alzheimer's disease, attention deficient hyperactivity disorder (ADHD), Huntington's disease, Parkinson's and schizophrenia, it added. ]]> <![CDATA[Glenmark to market Tiotropium Bromide DPI in Europe]]> https://biospectrumindia.com/news/95/11585/glenmark-to-market-tiotropium-bromide-dpi-in-europe.html https://biospectrumindia.com/news/95/11585/glenmark-to-market-tiotropium-bromide-dpi-in-europe.html Thu, 30 Aug 2018 20:55:00 +0530 Glenmark Pharmaceuticals Europe has entered into an exclusive licensing agreement for marketing generic Tiotropium Bromide dry powder inhaler, used in the treatment of chronic obstructive pulmonary disease, in Western Europe. According to Glenmark, respiratory is a core area of focus and this deal shows their commitment to increase product offerings within this segment. This is the second inhalation product in-licensed by Glenmark for the European market after Fluticasone/Salmeterol dry powder inhaler. Tiotropium Bromide DPI is a generic version of Boehringer Ingelheim’s Spiriva Handihaler. ]]> <![CDATA[CitiusTech inks strategic partnership with FluidEdge ]]> https://biospectrumindia.com/news/95/11568/citiustech-inks-strategic-partnership-with-fluidedge-.html https://biospectrumindia.com/news/95/11568/citiustech-inks-strategic-partnership-with-fluidedge-.html Wed, 29 Aug 2018 12:00:00 +0530 CitiusTech, a leading provider of healthcare technology solutions and services, announced today that it has made a strategic investment in FluidEdge Consulting (FluidEdge), a national healthcare management consulting company headquartered in Philadelphia, PA.     FluidEdge focuses its capabilities within the operations and IT areas of health plan, life sciences and provider organizations. It has an experienced team of healthcare technology and management consulting professionals with deep expertise in business, operations and technology, along with a strong understanding of emerging trends in value-based care.     CitiusTech has successfully developed deep and long-term relationships with leading healthcare organizations and technology companies. The company reached over $130 million in revenue in 2017 with a CAGR of over 30% over the last five years, through a mix of healthcare technology services and platforms. CitiusTech has been ranked in the 2018 Healthcare Informatics (HCI) 100 list, putting it among the top 100 companies in the US healthcare industry for the third consecutive year.   ]]> <![CDATA[Lupin launches generic contraceptive drugs]]> https://biospectrumindia.com/news/95/11566/lupin-launches-generic-contraceptive-drugs.html https://biospectrumindia.com/news/95/11566/lupin-launches-generic-contraceptive-drugs.html Tue, 28 Aug 2018 16:15:00 +0530 Pharma major Lupin announced the launch of Drospirenone, Ethinyl Estradiol, Levomefolate Calcium Tablets and Levomefolate Calcium Tablets, 3 mg/0.02 mg/0.451 mg and 0.451 mg (EQ Beyaz®), having received an approval from the United States Food and Drug Administration (FDA) earlier. Lupin’s Drospirenone, Ethinyl Estradiol, Levomefolate Calcium Tablets and Levomefolate Calcium Tablets, 3 mg/0.02 mg/0.451 mg and 0.451 mg, are the generic equivalent of Bayer’s Beyaz® Tablets. It is indicated for use by women to: Prevent pregnancy; Treat symptoms of premenstrual dysphoric disorder (PMDD) for women who choose to use an oral contraceptive for contraception; Treat moderate acne for women at least 14 years old, only if the patient desires an oral contraceptive for birth control; and Raise folate levels in women who choose to use an oral contraceptive for contraception.   Drospirenone, Ethinyl Estradiol and Levomefolate Calcium Tablets and Levomefolate Calcium Tablets, 3 mg/0.02 mg/0.451 mg and 0.451 mg had annual sales of approximately USD 80.8 million in the US (IQVIA MAT June 2018). ]]> <![CDATA[Lupin gets FDA nod for generic Gabapentin Tablets]]> https://biospectrumindia.com/news/95/11565/lupin-gets-fda-nod-for-generic-gabapentin-tablets.html https://biospectrumindia.com/news/95/11565/lupin-gets-fda-nod-for-generic-gabapentin-tablets.html Tue, 28 Aug 2018 16:00:00 +0530 Pharma major Lupin announced that it has received final approval for its Gabapentin Tablets USP, 600 mg and 800 mg from the United States Food and Drug Administration (FDA) to market this drug. Lupin’s Gabapentin Tablets USP, 600 mg and 800 mg is the generic version of Pfizer’s Neurontin® Tablets, 600 mg and 800 mg. It is indicated for the treatment of postherpetic neuralgia in adults and adjunctive therapy in the treatment of partial onset seizures, with and without secondary generalization, in adults and pediatric patients 3 years and older with epilepsy. Gabapentin Tablets USP, 600 mg and 800 mg had annual sales of approximately USD 180.7 million in the US (IQVIA MAT June 2018). ]]> <![CDATA[GNG, DMIMS to develop bio-banks for cancer tissues]]> https://biospectrumindia.com/news/95/11564/gng-dmims-to-develop-bio-banks-for-cancer-tissues.html https://biospectrumindia.com/news/95/11564/gng-dmims-to-develop-bio-banks-for-cancer-tissues.html Tue, 28 Aug 2018 15:50:00 +0530 GeNext Genomics Pvt. Ltd (GNG) and Research Cell, Datta Meghe Institute of Medical Sciences (DMIMS) have signed a Memorandum of Understanding (MoU) for collaboration to develop Bio-Banking of fully characterized and validated cancer patient tissues and cell lines, first of its kind in the country. As an innovation-led research-based company in engineered antibodies, GNG with its complete portfolio of monoclonal antibodies and cell culture expertise will not only develop various cancer cell lines along with DMIMS but will also validate and characterize tissue samples. This joint effort of GNG with DMIMS on bio-banking builds upon India’s bio-pharma mission for speedy drug discovery and biomarker studies. The roadmap is to create a system where Proteomics and Genomics data can be aligned, and research can be expediated for personalized medicine. With a lot  of focus  from Govt. of India on translational research, this collaboration will further strengthen the synergies between researchers and the medical fraternity to assess bench to bedside needs. It will also support some of the repurposing of the already available cancer drugs by means of antibody drug conjugates etc. ]]> <![CDATA[Panacea Biotec collaborates with Natco, Breckenridge]]> https://biospectrumindia.com/news/95/11556/panacea-biotec-collaborates-with-natco-breckenridge.html https://biospectrumindia.com/news/95/11556/panacea-biotec-collaborates-with-natco-breckenridge.html Tue, 28 Aug 2018 10:45:00 +0530 Panacea Biotec, one of the India's leading research based pharmaceutical and biotechnology companies, has entered into a tripartite agreement with Natco Pharma Ltd. and Breckenridge Pharmaceutical Inc. for the manufacture and supply of Azacitidine injection for the U.S. market under Breckenridge's already approved ANDA. Azacitidine is a generic equivalent of Vidaza which is marketed by Celgene Corporateion, U.S. As per the terms of the agreement, Natco has provided the technology for manufacturing Azacitidine to Panacea Biotec's facility located at Baddi, Himachal Pradesh, India. Panacea Biotec will be responsible for manufacture and supply of the product, which will be marketed, sold and distributed by Breckenridge in the U.S. The application (Prior Approval Supplement) for qualifying Panacea Biotec's site has been filed with US FDA and approval is expected in due course of time. Azacitidine is a nucleoside metabolic inhibitor indicated for the treatment of patients with the B myelodyplastic syndrome (MDS), having annual sales of about $ 140 million as reported by IMS, MAT, Dec 2017. Speaking on the occassion, Dr. Rajesh Jain, Managing Director, Panacea Biotec said, "We are excited about the collaboration with Natco and Breckenridge on Azacitidine. This collaboration will enable the company to grow its revenues and will also ensure increased capacity utilization of our state of the art oncology plant at Baddi." ]]> <![CDATA[Abbott India lines up 100 product launches over the next 5 years ]]> https://biospectrumindia.com/news/95/11552/abbott-india-lines-up-100-product-launches-over-the-next-5-years-.html https://biospectrumindia.com/news/95/11552/abbott-india-lines-up-100-product-launches-over-the-next-5-years-.html Mon, 27 Aug 2018 13:10:00 +0530 Drug major Abbott India aims to launch around 100 products over the next five years as it looks to strengthen existing therapy areas as well as grow over-the-counter portfolio. The Mumbai-based firm, which is a subsidiary of US-based Abbott Laboratories, had launched 21 new products in the country last fiscal. "Abbott plans to launch around 100 products over the next five years. Our focus remains on growing existing therapy areas such as gastroenterology, metabolics, vaccines, central nervous system and women's health," the company's Managing Director Ambati Venu said. The company is also looking at strengthening its over-the-counter portfolio with a wider range of product formats, he added. "In total, our pharmaceutical business covers 90 per cent of therapies in India so our goals are to increase the depth and breadth of the medicines we offer in these areas, ensure broader reach to people in India and continue to launch improved medicines that make it better or easier for people to get healthy," Venu said. He added that the company's strategic priorities are focused on making life better for the patient. "Over the next five years, we want to create an innovative healthcare ecosystem that improves access and is based on technology and insights, for both now' and next' therapies," he said. As part of the growth strategy, the company wants to accelerate its established brands by creating innovative services for patients, doctors, care givers and chemists across the continuum of care, he added. "And we believe that technology innovation through digital ecosystem is a key in markets like India, with increased penetration due to the recent boom in the telecom sector. "The current state of digital innovation in India, though rapid, is perhaps being carried out in silos pharma, diagnostics and doctors need to collaborate effectively to truly help improve health for people in India," Venu said. The company is in the unique position to help connect all the parties and be a holistic healthcare provider across the continuum of care, keeping patients as the focal point and that is going to be the key to company's sustainable success, he added. Abbott India, which is listed on the BSE, currently offers over 110 brands which cover multiple therapeutic areas such as women's health, gastroenterology, neurology, thyroid, pain management, general care, vitamins and vaccines. Therapeutic segments related to cardiac, diabetes, derma, neuro portfolio and hospital business fall under another group entity Abbott Healthcare Pvt Ltd (AHPL). Together, Abbott India and AHPL form the Established Pharmaceuticals business of Abbott in India. ]]> <![CDATA[Ozempic reduces major cardiovascular risk in Type 2 diabetics ]]> https://biospectrumindia.com/news/95/11548/ozempic-reduces-major-cardiovascular-risk-in-type-2-diabetics-.html https://biospectrumindia.com/news/95/11548/ozempic-reduces-major-cardiovascular-risk-in-type-2-diabetics-.html Mon, 27 Aug 2018 11:45:00 +0530 Novo Nordisk’s  Ozempic® (semaglutide) consistently reduced the risk of the composite outcome of time to first occurrence of non-fatal heart attack, non-fatal stroke or cardiovascular death (collectively termed major adverse cardiovascular events, MACE) in people with type 2 diabetes at high cardiovascular risk regardless of previously having had a cardiovascular event at the start of the trial. Findings from two post-hoc subgroup analyses of the SUSTAIN 6 trial and one post-hoc meta-analysis of MACE in the SUSTAIN 1-5 trials were presented today at the ESC Congress 2018, organised by the European Society of Cardiology, in Munich, Germany. The SUSTAIN 6 post-hoc analyses found that reduction in the risk of MACE was consistent in people at high cardiovascular risk treated with Ozempic® regardless of their cardiovascular risk profile at the start of the trial, including whether or not they had a prior heart attack or stroke, and whether they had cardiovascular risk factors or established cardiovascular disease. SUSTAIN 6 was a pre-approval cardiovascular outcomes trial in 3,297 people with type 2 diabetes and established cardiovascular disease or with at least one cardiovascular risk factor, compared to placebo, both in addition to standard of care. The post-hoc pooled meta-analysis of the SUSTAIN 1-5 efficacy trials, which included 4,807 people, trended towards a lower risk of MACE in people taking Ozempic®. The comparators included in SUSTAIN 1-5 were placebo, sitagliptin, exenatide extended-release and insulin glargine U100. The overall incidence of MACE was low across the SUSTAIN 1-5 trials and, due to the low number of events, this reduction did not achieve statistical significance.   ]]> <![CDATA[Sun Pharma’s Aggrenox gets USFDA nod]]> https://biospectrumindia.com/news/95/11542/sun-pharmas-aggrenox-gets-usfda-nod.html https://biospectrumindia.com/news/95/11542/sun-pharmas-aggrenox-gets-usfda-nod.html Fri, 24 Aug 2018 11:25:00 +0530 Sun Pharma has received final USFDA approval for Aspirin and Dipyridamole. This is a generic copy of Boehringer Ingelheim Pharma’s drug Aggrenox.  Aggrenox is used to lower the risk of stroke in people who have had a mini-stroke or stroke due to a blood clot. Aggrenox and its generics are estimated to have US sales of approximately $230mn in the US and with the lower competition, Sun pharma expect to make $8-10mn/annum from this drug. ]]> <![CDATA[Hindustan Syringes, Niraj Industries get MDSAP certification]]> https://biospectrumindia.com/news/95/11539/hindustan-syringes-niraj-industries-get-mdsap-certification.html https://biospectrumindia.com/news/95/11539/hindustan-syringes-niraj-industries-get-mdsap-certification.html Thu, 23 Aug 2018 15:25:00 +0530 The group companies of Hindustan Medical Devices- Hindustan Syringes & Medical Devices Ltd, one of the largest manufacturers of Disposable Syringes in the World and the largest for Auto Disable syringes and a strong advocate for Make in India for Medical Devices and Niraj Industries were among the first set of Indian Manufacturers of Disposable Medical Devices to be awarded the prestigious MDSAP quality assurance certificate. The Medical Device Single Audit Program (MDSAP) allows a single regulatory audit of a medical device manufacturer's Quality Management System (QMS) which satisfies the requirements of multiple regulatory jurisdictions to address Patient Safety concerns. Manufacturers can be audited once for compliance with the standard and regulatory requirements of up to five different medical device markets: Australia, Brazil, Canada, Japan and the United States. For manufacturers, MDSAP is of benefit as it reduces the overall number of audits or inspections and optimizes the time and resources expended on audit activities. MDSAP certificate aims to promote globally a greater alignment of regulatory approaches and technical requirements which are based on international standards and best practices. Additionally, it also promotes consistency, predictability and transparency of regulatory programs. MDSAP certificate is an addition to ICMED (Indian Certification for Medical Devices) HMD received from QCI (Quality Council of India). ICMED Certification process allowed us to build competencies and confidence needed to strive for MDSAP - explained Rajiv Nath “This tough certificate also endorses the robustness and world class quality assurance of HMD factories that produce disposable and auto disable syringes, insulin pen needles, and surgical blades among other devices, “Niraj Industries is dedicated to Surgical Blades & Scalpels and Hindustan Syringes is making the balance range of Disposables” - Rajiv Nath added. Audits are conducted by Auditing Organizations (AO), such as UL, authorized by the participating Regulatory Authorities (RA) to audit under tough MDSAP requirements. In India 23 Categories of Medical Devices are Regulated under Medical Device Rules 2017 under Drugs & Cosmetics Act. Manufacturers & Exporters need to comply with importing Countries Regulatory requirements to address importing Countries Patient Safety Concerns which also act as Market Access Trade Barriers. Manufacturers need to continually upgrade their manufacturing capabilities to address these Market Access Regulatory requirement that keep getting tougher by the day. ]]> <![CDATA[Wasazra Pharma to expand its biz in India]]> https://biospectrumindia.com/news/95/11538/wasazra-pharma-to-expand-its-biz-in-india.html https://biospectrumindia.com/news/95/11538/wasazra-pharma-to-expand-its-biz-in-india.html Thu, 23 Aug 2018 13:15:00 +0530 Wasazra is one of the emerging pharmaceutical companies in India, whose goal is to ensure that no patient is denied access to high quality & affordable medicines. The company has spread across Uttar Pradesh with presence in more than 50 territories. This public limited company is led by Mr. Syed Mohammad Fauzan Akhtar, a young entrepreneur spreading his wings in pharma industry by giving affordable and result oriented medicines. Wasazra started its business in June 2017 and has grown multifold in a span of one year and now plans to expand its business operations throughout India. 3rd Eye Advisory Ltd. is the strategic consultant for its business growth and marketing. The company is on a mission to ensure 'Reachability, Affordability & Quality' of the products, across the globe for a healthier and happier world. Wasazra has a portfolio into tablets, injections, syrups, capsules, soft-gelatin capsules and sachets. The product line falls into anti-allergic, anti-bacterial injections, calcium and multivitamin tablets and pre-biotic. The company further intends to expand its portfolio by adding anti-cancer, anti-malarial, vaccines and anti-emetic drugs. Wasazra aims to set up a state of the art self-manufacturing facility which will generate employment and contribute towards Pradhan Mantri Bharatiya Jan Aushdhi Yojana as public social responsibility. Fauzan Akhtar, Director Wasazra Pharmaceuticals Ltd. said, "We believe in ethical business model which creates a win-win situation for everyone in the ecosystem. Since 2017, with a small team of MRs and ASMs we have covered major markets in Uttar Pradesh. We plan to become a recognized brand in pharma industry. Wasazra being an Indian company and promoted under Make in India, we have a huge scope to build business and be in every household as and when required. Speedy introduction of generic drugs into the market is our mainfocus." ]]> <![CDATA[Torrent Pharmaceuticals Recalls 14 Lots of Valsartan]]> https://biospectrumindia.com/news/95/11519/torrent-pharmaceuticals-recalls-14-lots-of-valsartan.html https://biospectrumindia.com/news/95/11519/torrent-pharmaceuticals-recalls-14-lots-of-valsartan.html Tue, 21 Aug 2018 13:20:00 +0530 Torrent Pharmaceuticals Limited is voluntarily recalling 14 lots of Valsartan/Amlodipine/HCTZ tablets to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Zhejiang Huahai Pharmaceuticals. The impurity detected in the API is N-nitrosodimethylamine (NDMA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC) classification. To date, Torrent Pharmaceuticals Limited has not received any reports of adverse events related to this recall. Valsartan is used to control high blood pressure and for the treatment of heart failure. In combination with amlodipine plus hydrochlorothiazide, it is used to control high blood pressure. Patients should contact their pharmacist or physician who can advise them about an alternative treatment prior to returning their medication. Patients who are on valsartan should continue taking their medication, as the risk of harm to the patient's health may be higher if the treatment is stopped immediately without any alternative treatment. This recall is being conducted with the knowledge of the U.S. Food and Drug Administration. ]]> <![CDATA[Jubilant Life Sciences earmarks Rs. 550 Cr capex]]> https://biospectrumindia.com/news/95/11515/jubilant-life-sciences-earmarks-rs-550-cr-capex.html https://biospectrumindia.com/news/95/11515/jubilant-life-sciences-earmarks-rs-550-cr-capex.html Mon, 20 Aug 2018 14:30:00 +0530 Pharma company Jubilant Life Sciences has earmarked Rs 550 crore for capital expenditure in the current financial year.  It is also planning to invest Rs 300 crore in research and development (R&D) in FY19.  "To meet the increased demand in our businesses, we plan to invest about Rs 550 crore in capital expenditure and Rs 300 crore in R&D during the year," Jubilant Life Sciences Chairman Shyam S Bhartia has said at a recent conference call. He said the company will continue its efforts to strengthen its balance sheet by reducing debt and improving financial ratios.  The drug-maker is also looking to grow its revenue and operating profits in FY19 and is banking on growth drivers such as speciality pharmaceuticals, active pharmaceutical ingredient (API) and generics and life science ingredients, according to Bhartia.  In speciality pharmaceuticals, new products and current contracts execution in radio-pharmaceuticals are expected to drive growth, while in API and generics, growth will be driven by higher volumes from new product launches and market expansions and also from initiatives to optimise costs from higher efficiencies, he said.  "In the life science ingredients segment, will see growth in revenues from new product launches, new orders, new capacities coming on stream and de-bottlenecking of existing plants," he said.  Bhartia informed that the company is increasing capacity in solid dosage formulations at Roorkee, which is expected to be completed in December quarter to meet the increasing requirements.  It is also taking various initiatives to reduce cost from higher efficiencies and also input material cost optimisation.  Commenting on filings and registrations, Bhartia said the company has filed 107 ANDAs (abbreviated new drug applications) in the US market, including a mix of solid dosage filings, injectable filings and NDA and 505 (b) (2) filings, of which 37 are pending approval.  "We have filed two ANDAs during the (June) quarter and expect to file around 10 ANDAs during the year. We have a pipeline of at least five products in our radio-pharmaceuticals business which we expect to file and launch in the next few years," he said.  Jubilant Life Sciences reported a 39.42 per cent rise in consolidated net profit to Rs 200.37 crore for the June quarter.  Its revenue from operations also grew to Rs 2,079 crore for the quarter, from Rs 1,596.05 crore in the same year-ago period.  ]]> <![CDATA[Cadila to acquire majority stake in Windlas Healthcare]]> https://biospectrumindia.com/news/95/11513/cadila-to-acquire-majority-stake-in-windlas-healthcare.html https://biospectrumindia.com/news/95/11513/cadila-to-acquire-majority-stake-in-windlas-healthcare.html Mon, 20 Aug 2018 10:50:00 +0530 Cadila Healthcare Ltd, which operates under the Zydus Cadila brand, has agreed to acquire a 51 per cent stake in pharmaceuticals company Windlas Healthcare Pvt. Ltd for Rs 155.5 crore. The acquisition will help the company expand its pharmaceutical manufacturing footprint. Windlas Healthcare is a subsidiary of Windlas Biotech Pvt. Ltd, which is backed by private equity firm Tano Capital. Tano had invested $12.96 million in Windlas Biotech in 2015. Windlas Healthcare, which was set up in February 2010, develops and market pharmaceutical products and formulations. The company clocked revenue of Rs 33.31 crore in the year ended 31 March 2018 compared with Rs 27.67 crore and Rs 29.12 crore in 2016-17 and 2015-16, respectively. It recorded a net profit of Rs 5.37 crore in the last financial year. ]]> <![CDATA[Sun Pharma announces FDA approval for cyclosporine ophthalmic solution]]> https://biospectrumindia.com/news/95/11508/sun-pharma-announces-fda-approval-for-cyclosporine-ophthalmic-solution.html https://biospectrumindia.com/news/95/11508/sun-pharma-announces-fda-approval-for-cyclosporine-ophthalmic-solution.html Fri, 17 Aug 2018 17:35:00 +0530 Sun Pharmaceutical Industries Ltd. has announced that Sun Pharma has received approval for CEQUA (cyclosporine ophthalmic solution) 0.09%, from the U.S. Food and Drug Administration. CEQUA is indicated to increase tear production in patients with keratoconjunctivitis sicca (dry eye). CEQUA provides the highest FDA-approved concentration of cyclosporine A (CsA) and is the first and only approved CsA product that incorporates a nanomicellar technology. The innovative nanomicellar formulation allows the CsA molecule to overcome solubility challenges, penetrate the eye’s aqueous layer and prevents the release of the active lipophilic molecule prior to penetration. In the Phase 3 confirmatory trial on CEQUA, after 12 weeks of treatment, as compared to vehicle, CEQUA showed statistically significant improvement in the primary endpoint, Schirmer’s score (a measurement of tear production) (p<0.01). Improvements in secondary endpoints (i.e. ocular staining assessments) were seen as early as 1 month after initiating treatment. CEQUA is dosed twice daily and will be available as a single-use vial. The nanomicellar formulation technology uses micelles, which are gelatinous aggregates of amphipathic (both hydrophobic and hydrophilic) molecules formed at a well-defined concentration. The small size of the nanomicelles facilitates entry into corneal and conjunctival cells, enabling delivery of high concentrations of CsA. “Dry Eye Disease represents an area of high unmet medical need, with a significant number of patients who are currently untreated,” said Abhay Gandhi, CEO, North America, Sun Pharma. “The U.S. FDA approval of CEQUA represents a long-awaited dry eye treatment option and is an important milestone in the development of Sun’s Ophthalmics business. CEQUA, with its novel nanomicellar formulation for a proven dry eye medication, delivers a lipophilic molecule in a clear solution form.” Additionally, Jodi Luchs, MD, the principal investigator behind the CEQUA confirmatory Phase 3 trial, noted: “Dry eye is a complex disease that lacks a ‘one-size-fits-all’ approach. As a clinician treating a high volume of dry eye patients, it’s important to have multiple treatment modalities available at my disposal. Given its strong clinical trial performance, the approval of CEQUA is welcomed news, and I look forward to offering my patients this compelling new option.” CEQUA (cyclosporine ophthalmic solution) 0.09%, for topical ophthalmic use will be commercialized in the U.S. by Sun Ophthalmics, the branded ophthalmics division of Sun Pharma’s wholly owned subsidiary.   ]]> <![CDATA[AstraZeneca receives marketing permission for cancer drug in India ]]> https://biospectrumindia.com/news/95/11504/astrazeneca-receives-marketing-permission-for-cancer-drug-in-india-.html https://biospectrumindia.com/news/95/11504/astrazeneca-receives-marketing-permission-for-cancer-drug-in-india-.html Fri, 17 Aug 2018 12:20:00 +0530 AstraZeneca Pharma India Limited (AZPIL) recently announced that it has received Import & Market permission for olaparib (Lynparza® )100 mg and 150 mg tablets in India by the Drug Controller General of India (DCGI). The receipt of this permission paves way for the launch of olaparib (Lynparza®) in India, subject to the receipt of further related statutory approvals and licenses. For ovarian cancer, olaparib is indicated for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube or primary peritoneal cancer, who are in a complete or partial response to platinum-based chemotherapy. It is also indicated for the treatment of adult patients with deleterious or suspected deleterious germline BRCA-mutated advanced ovarian cancer who have been treated with three or more prior lines of chemotherapy. For breast cancer, olaparib is indicated for patients with deleterious or suspected deleterious gBRCAm, human epidermal growth factor receptor 2 (HER2)-negative metastatic breast cancer who have previously been treated with chemotherapy in the neoadjuvant, adjuvant or metastatic setting. Patients with hormone receptor (HR)-positive breast cancer should have been treated with a prior endocrine therapy or be considered inappropriate for endocrine treatment Olaparib (Lynparza®) is a patented product of the AstraZeneca group. Gagan Singh, Managing Director, AstraZeneca Pharma India Limited said, “The import and market permission for olaparib is a significant milestone for women in India living with platinum-sensitive relapsed ovarian cancer and BRCA-mutated HER-2 negative metastatic breast cancer, which has historically been difficulty-to-treat diseases. Today’s approval will bring this innovative, targeted option that may help to delay disease progression for these patients.” Breast and ovarian cancers are the leading causes of cancer-related deaths in women of India. As per three-year report of population based cancer registries-2012-2014 in India, ovarian cancer is the third leading site of cancer among women, trailing behind breast and cervical cancer. The age-adjusted incidence rates of ovarian cancer vary between 1.7 and 15.2 per 100,000 population in different parts of the country. Ovarian cancer has the worst prognosis among all gynaecological malignancies. The overall 5-year survival rate was 46% in USA in 2017 while it was 15·6% during the period of 2010-14 in India, primarily due to the late stage of the disease at diagnosis. As there is no cure for relapsed ovarian cancer, the primary aim of treatment is to slow progression of the disease for as long as possible and improve or maintain the patient’s quality of life. Breast cancer has been ranked number one cancer among Indian females with age adjusted rate ranging from 4.4 to 41.0 per 100,000 women. Mortality-to-incidence ratio was for breast cancer was found to be as high as 0.66 in rural registries whereas as low as 0.08 in urban registries. It is projected that 56,276 and 1,79,790 Indian patients will be suffering from ovarian cancer and breast cancer respectively in 2020. In India, 5-year survival rate for patients with breast cancer is 66·1% during the period of 2010-14. Most of the Indian studies have showed an inverse relationship of stage-of disease with survival. Patients diagnosed with BRCA-related metastatic breast cancer are often younger than other breast cancer patients, and their disease is often much more aggressive and difficult to treat. While there is currently no cure for metastatic breast cancer, olaparib now offers a new, targeted option that may help to delay disease progression for these patients. ]]> <![CDATA[Merck snatches Australian CRISPR nickase patent]]> https://biospectrumindia.com/news/95/11496/merck-snatches-australian-crispr-nickase-patent.html https://biospectrumindia.com/news/95/11496/merck-snatches-australian-crispr-nickase-patent.html Thu, 16 Aug 2018 13:50:00 +0530 Merck, the vibrant science and Technology Company announced that the Australian Patent Office has allowed the company's patent application for the use of paired CRISPR nickases. Paired nickases represent a significant step in increasing safety by driving specificity through a highly flexible and efficient approach to reduce off-target effects. This improves CRISPR's ability to fix diseased genes while not affecting healthy ones. Paired CRISPR nickase methods build on other technologies in Merck’s CRISPR patent portfolio, including CRISPR integration. Commercial organizations need Merck’s IP for CRISPR-based insertion of DNA if they want correct genetic defects in the somatic cells of gene therapy patients. Merck is licensing this patent portfolio for all fields of use. The allowed patent application covers a foundational CRISPR strategy in which two CRISPR nickases are targeted to a common gene target and work together by nicking or cleaving opposite strands of chromosomal sequence to create a double-stranded break. This process can optionally include an exogenous or donor sequence for insertion in the same manner as Merck's patented CRISPR integration technology. The requirement of two CRISPR binding events greatly reduces the chances of off-target cutting at other locations in the genome. In addition to allowing a patent application on paired nickases, the Australian Patent Office recently announced the formal grant of Merck's 2017 CRISPR integration patent, following withdrawal of four independent, anonymously filed oppositions. Merck's CRISPR integration patent portfolio includes granted patents in Australia, Canada, China, Europe, Israel, Singapore and South Korea. These CRISPR patents are directed to chromosomal integration, or cutting of the sequence of eukaryotic cells and insertion of a synthetic exogenous DNA sequence to make a desired genomic change. Paired CRISPR nickase methods build on other technologies in Merck's CRISPR patent portfolio, including CRISPR integration. Commercial organizations need Merck's intellectual property for CRISPR-based insertion of DNA if they seek to correct genetic defects in the somatic cells of gene therapy patients. Merck is licensing this patent portfolio for all fields of use. As a company that for the past 14 years has been highly involved in genome-editing innovation, Merck recognizes that genome editing has resulted in major advancements in biological research and medicine. At the same time, the growing potential of genome-editing technologies has opened scientific, legal and societal concerns. As both a user and supplier of genome-editing technology, Merck supports research with genome editing under careful consideration of ethical and legal standards. Merck has established a Bioethics Advisory Panel to provide guidance for research in which its businesses are involved, including research on or using genome editing, and has defined a clear operational position taking into account scientific and societal issues to inform promising therapeutic approaches for use in research and applications. Merck was the first company to offer custom biomolecules for genome editing globally (TargeTron™ RNA-guided group II introns and CompoZr™ zinc finger nucleases), driving adoption of these techniques by researchers all over the world. Merck was also the first company to manufacture arrayed CRISPR libraries covering the entire human genome, accelerating disease cures by allowing scientists to explore more questions about root causes. ]]> <![CDATA[Pharma exports to cross $19 B in FY19: Pharmexcil]]> https://biospectrumindia.com/news/95/11480/pharma-exports-to-cross-19-b-in-fy19-pharmexcil.html https://biospectrumindia.com/news/95/11480/pharma-exports-to-cross-19-b-in-fy19-pharmexcil.html Tue, 14 Aug 2018 10:15:00 +0530 Pharmaceutical exports from the country are expected to cross $19 billion in worth during the current fiscal despite muted growth in the North American markets, according to Pharmexcil, a body under Union Commerce Ministry. Pharma exports fetched $17.27 billion in the previous fiscal and this year it was expected to be between $19 billion and $20 billion, Pharmaceuticals Export Promotion Council (Pharmexcil), Director General Uday Bhaskar said. During the first quarter of the current fiscal, pharma exports clocked an increase of 17.76 percent to $4.6 billion against $3.9 billion during the corresponding quarter a year ago, he said. "Last year we had 2.92 percent growth in Pharma exports. We are expecting that we may reach $19 billion to $20 billion in the year 2018-19. Old markets are getting revived and we are also entering into new markets," said Mr. Bhasker. He said most of the issues with regards to the United States Food and Drug Administration (USFDA), which had impacted exports from India in the first five months of last fiscal, were getting resolved. "Chinese market is also opening up. We are working on that. China has removed tariff on certain cancer drugs. All these create conducive atmosphere for Indian drug exporters," he said. Bhaskar said Pharmexcil had been advising drug manufacturers in the country to look for emerging markets to offset the US impact. North America, the largest market for Indian Pharma exporters, witnessed a negative growth of 7.35 percent to $5.35 billion in FY 18 against $ 5.77 billion in the previous year. It constitutes over 30 percent of Indian pharma exports followed by Africa and the European Union with 19.37 percent and 15.92 percent respectively. However, during the first quarter ending June 30, exports to North America registered 17.67 percent growth to $ 1.40 billion, Bhaskar added. Bhaskar said that Pharmexcil was also taking a business delegation to China later this month to tap the potential of the Asia's largest economy following some regulatory changes in the neighbouring country. "China made zero duty on anti-cancer drugs. They also simplified product registration procedures... there are some proactive steps by the Chinese Government," he said. Pharma exports to China during the last fiscal registered a growth of over 37 percent to $ 200 million against $145.5 million in 2016-17, according to Pharmexcil statistics.   ]]> <![CDATA[Epygen Biotech gets CSIR IMTECH Permit for Ischemic Stroke drug]]> https://biospectrumindia.com/news/95/11476/epygen-biotech-gets-csir-imtech-permit-for-ischemic-stroke-drug.html https://biospectrumindia.com/news/95/11476/epygen-biotech-gets-csir-imtech-permit-for-ischemic-stroke-drug.html Mon, 13 Aug 2018 14:55:00 +0530 Epygen Biotech Pvt. Ltd. became the first company in India to acquire the exclusive licensing of Novel Biological Entity (NBE) from CSIR-IMTECH for treatment of Ischemic strokes CSIR transferred the technology to Epygen Biotech Pvt Ltd that would carry out pre-clinical studies and subsequently clinical trials. Epygen is the first company in India with the exclusive license of this Novel Biological Entity (NBE) thrombolytic protein for ischemic stroke. This drug will revolutionize the way Ischemic strokes are treated around the globe. Ischemic  Stroke : Brain stroke, which occurs due to the blockage of an artery that supplies oxygen to the brain, is the leading cause of death and disability in the patients. An estimated 12 lakh Indians suffer from it every year. According to the American Stroke Association (ASA), brain strokes are the second leading cause of death in the world with a staggering 15 million people effected causing 11 million people either die or become permanently disabled. The prevalence of stroke is much higher in India than the west and about 87% of all the strokes are ischemic strokes. This drug that can be administered to ischemic stroke patient within 8-10 hours, unlike a popular medicine that needs to be given within the first three hours, it is low in cost and doesn’t have side effects unlike other drugs used for Ischemic strokes.   ]]> <![CDATA[WaveMaker launches HyScale for digital enterprise]]> https://biospectrumindia.com/news/95/11475/wavemaker-launches-hyscale-for-digital-enterprise.html https://biospectrumindia.com/news/95/11475/wavemaker-launches-hyscale-for-digital-enterprise.html Mon, 13 Aug 2018 14:35:00 +0530 WaveMaker Inc. / Pramati Technologies has launched WaveMaker HyScale, a continuous delivery automation platform that accelerates container adoption for large deployments in regulated industries like BFSI, healthcare, and telecom. HyScale is part of the WaveMaker modernization suite for enterprises.   The current wave of micro services are supporting long term investments by enterprises on new applications. But there is a shortage of skills and time to deploy these applications at scale, and in a way that’s lighter on infrastructure. This is where HyScale helps by providing an automated containerization workflow.    HyScale abstracts underlying complexity with Docker and Kubernetes, allowing DevOps teams to focus on what matters most, the application and its services.   “Kubernetes solves the container orchestration problem but how to generate containers at scale? HyScale plugs into existing enterprise CI tools like Jenkins and automatically generates container images which can be pushed in a click to any container runtime that supports Kubernetes. It acts a single pane of glass for the entire delivery workflow across multiple Kubernetes clusters.” said WaveMaker director of platform, Mayur Shah.   WaveMaker HyScale is free for the first 30 days. It can be used on the cloud or on-premise. HyScale can also be white-labeled for companies looking for custom delivery systems.   ]]> <![CDATA[PharmaLytica 2018 highlights Quality Culture and Regulatory Compliance trends of the Pharma Sector]]> https://biospectrumindia.com/news/95/11464/pharmalytica-2018-highlights-quality-culture-and-regulatory-compliance-trends-of-the-pharma-sector.html https://biospectrumindia.com/news/95/11464/pharmalytica-2018-highlights-quality-culture-and-regulatory-compliance-trends-of-the-pharma-sector.html Mon, 13 Aug 2018 10:30:00 +0530 UBM India, the organisers of CPhI / P-MEC India, the leading global pharma trade show and conference, recently hosted the 5th edition of PharmaLytica 2018 in Hyderabad at the HITEX Exhibition Centre, with BioSpectrum serving as the conference partner. The two day event, 10-11th Auguest 2018, was inaugurated by Dr. Preeti Meena IAS, Director, Drugs Control Administration, Hyderabad along with Mr. Uday Bhaskar Reddy, Director General, Pharmaceuticals Export Promotion Council (PHARMEXCIL); Dr. P V Appaji, Director General Emeritus, Pharmaceuticals Export Promotion Council (PHARMEXCIL); Mr. Avinash Talwar, Director & Head, Global Sourcing (Strategic & Plant) Dr. Reddy's Laboratories Ltd, Dr. R B Smarta, MD, Interlink Marketing Consultancy, Mr. Yogesh Mudras, Managing Director, UBM India and Mr. Rahul Deshpande, Group Director, UBM India amidst an industry gathering. During the inaugural ceremony, Uday Bhaskar Reddy stated, "In FY 2017-18, Indian Pharma exports grew to $ 17.26 billion. One of the key development to notice is, despite 8% negative growth witnessed in the US market, we still grew positive by 2.92%. There are potential markets to explore like China, South Africa and CIS markets and even if negative growth continues in the US market, the Indian Pharma companies should be confident and focus on growth and explore opportunities in the potential markets”. The two day event saw brainstorming sessions by industry experts focusing on developing a quality manufacturing setup in the pharma sector, involving more technologies to revolutionize the sector further striking a balance between pricing and quality. The event witnessed a participation from over 150 exhibitors from across the country including notable industry players such as Kirloskar, Standard Group of Companies, Borosil Glass Works, Bry-Air Asia, Rotomark Innovations, Control Print, Gandhi Automation, Leistung Engineering, Mack Pharmatech, Domino Printech, Autocal Solutions, FLIR Systems, Helios Concrew, Kirloskar Pneumatics, S.K. Pharma Machinery, NPM Machinery, Goel Scientific, GMM Pfaudler, ELGI Equipments, First Source Lab, Apex Chromatography, Valfit Engineers, Integrated Cleanroom Technology, Dumra Machines, Sigma Scientific Glass, among many others. ]]> <![CDATA[Cipla gets selling rights for cancer drug in US]]> https://biospectrumindia.com/news/95/11463/cipla-gets-selling-rights-for-cancer-drug-in-us.html https://biospectrumindia.com/news/95/11463/cipla-gets-selling-rights-for-cancer-drug-in-us.html Sat, 11 Aug 2018 11:45:00 +0530 Drug major Cipla said its subsidiary has secured rights from Hyderabad-based MSN Laboratories to market and distribute colon cancer treatment drug Capecitabine in the US market.   Cipla USA, Inc, a subsidiary of the company will be marketing the drug in strengths of 150 and 500 mg tablets.   The company's product is generic equivalent of Genentech's Xeloda.   Capecitabine tablets are indicated in patients with colon cancer and for the treatment of patients with metastatic breast cancer after failure of prior anthracycline-containing chemotherapy.   As per IQVIA (IMS Health) data, Xeloda and its generic equivalents had sales of around USD 178 million in the US for 12-month period ending June 2018. ]]> <![CDATA[Glenmark inks pact with True North for pain management]]> https://biospectrumindia.com/news/95/11462/glenmark-inks-pact-with-true-north-for-pain-management.html https://biospectrumindia.com/news/95/11462/glenmark-inks-pact-with-true-north-for-pain-management.html Sat, 11 Aug 2018 11:25:00 +0530 Glenmaerk has formed a joint venture with private equity firm True North for its pain management and orthopedic products business in India and Nepal. Under this collaboration, Glenmark's orthopaedic and pain management business, valued at Rs 635 crore, will be transferred to a new entity to-be incorporated by True North. The new entity would be named as 'Integrace Private Ltd' and will market the product portfolio in India and Nepal, Glenmark said in a statement.   The transaction is expected to be completed in 2-3 months, it added. As part of the deal, Sujesh Vasudevan, President India Formulations, Middle East and Africa at Glenmark will join the board of Integrace. Glenmark's orthopaedic and pain management business in India, consisting of brands such as Esoz, Bon K2, Collasmart, and Lizolid, clocked revenue of Rs 155.8 crore in 2017-18.   Sujesh Vasudevan, who heads Glenmark's India formulations business, will join the board of the new entity, which will house two businesses.   ]]> <![CDATA[TAKE Solutions reports a strong profit growth of 51.65% YoY in Q1 FY19]]> https://biospectrumindia.com/news/95/11461/take-solutions-reports-a-strong-profit-growth-of-51-65-yoy-in-q1-fy19.html https://biospectrumindia.com/news/95/11461/take-solutions-reports-a-strong-profit-growth-of-51-65-yoy-in-q1-fy19.html Sat, 11 Aug 2018 10:50:00 +0530 TAKE Solutions Ltd. a globally recognized domain intensive services provider in Life Sciences announced its financial results for Quarter ending 30th June 2018. Key Highlights from this quarter: Revenue at INR 4675.4 Mn; growth of 31.9% Y-o-Y and 3% Q-o-Q; Profit at INR 541.68 Mn, growing at 51.65% Y-o-Y Bioanalytical facility at Bangalore and Manipal have successfully completed USFDA inspections with no observations Closed a landmark renewal contract with a large pharma player for regulatory outsourcing services Expanded capacity by moving to larger facilities in Princeton and Bangalore Recognized as a ‘Leader’in the IDC MarketScape: Worldwide Life Science R&D BPO Services 2018 Vendor Assessment Awarded 20+ BA/BE studies across APAC Srinivasan H R, Vice Chairman and Managing Director, TAKE Solutions said, “We have started the new fiscal year on a very strong note. Our life sciences business continues to be our growth engine this quarter, while other verticals maintained momentum. Customers across geographies especially North America and Europe are embracing our robust solution and technology framework to accelerate their digital transformation journeys. With a good set of wins during the quarter, a robust deal in pipeline and investments in research and innovation in the Life Science industry, we are well positioned for the future to be a half a million-dollar enterprise by 2021.” ]]> <![CDATA[Akums Bags Prestigious Business Leadership Award ]]> https://biospectrumindia.com/news/95/11458/akums-bags-prestigious-business-leadership-award-.html https://biospectrumindia.com/news/95/11458/akums-bags-prestigious-business-leadership-award-.html Fri, 10 Aug 2018 13:20:00 +0530 Akums Drugs and Pharmaceuticals Ltd., one of India’s largest Contract Drug Research and Manufacturing Organizations (CRAMS), has won the prestigious Business Leadership Award at the National CSR Summit and Awards by the Indian Achievers Forum. The company offers exclusive services in the field of commercial drug development from the point of formulation till its market launch. The organization has 13 advanced manufacturing units which collectively are producing 12 per cent of the nation’s drug supply. Earlier this year, Akums was awarded the ‘Indian Pharma Leader Award’ by the Department of Pharmaceuticals, Government of India. Moreover, the organization has been featured in 2016 issue of Next Fortune 500. The National CSR Summit and Awards is organized regularly by the Indian Achievers Forum. The purpose of this award ceremony is to bring people from diverse fields together and give them a common platform to share their knowledge, experiences, ideas and thoughts as well as to network. This year’s award ceremony was held at the SILVER OAK, Habitat World, India Habitat Centre, New Delhi.   ]]> <![CDATA[Astrazeneca gets import and market permission for its cancer drug]]> https://biospectrumindia.com/news/95/11453/astrazeneca-gets-import-and-market-permission-for-its-cancer-drug.html https://biospectrumindia.com/news/95/11453/astrazeneca-gets-import-and-market-permission-for-its-cancer-drug.html Thu, 09 Aug 2018 15:55:00 +0530  Astrazeneca Pharma has received Import and Market permission in Form 45 (Marketing Authorization- Additional Indication) from the Drugs  Controller General of India .   The approval has been for Osimertinib Tablet 40 mg and 80 mg (TagrissoTM) indicated as first-line treatment of patients with locally advanced or metastatic Non-Small Cell Lung Cancer (NSCLC) whose tumours have Epidermal Growth Factor Receptor (EGFR) exon 19 deletions or exon 21 (L858R) substitutions mutations.   The receipt of this Import and Market permission paves way for the launch of Osimertinib Tablets (TagrissoTM) for first-line treatment of patients in India, subject to the receipt of other related statutory approvals and licenses.   The first-line use of Osimertinib offers potential new standard of care. ]]> <![CDATA[Siemens Healthineers opens diagnostics manufacturing unit in Gujarat]]> https://biospectrumindia.com/news/95/11452/siemens-healthineers-opens-diagnostics-manufacturing-unit-in-gujarat.html https://biospectrumindia.com/news/95/11452/siemens-healthineers-opens-diagnostics-manufacturing-unit-in-gujarat.html Thu, 09 Aug 2018 14:55:00 +0530 Siemens Healthcare aspires to become the trusted partner of healthcare providers worldwide. The partner that they can rely on to help drives their clinical excellence, operational efficiency, and profitability. Siemens Healthineers has started diagnostics manufacturing facility at Vadodara, Gujarat with an aim to help deliver better outcomes to patients and significantly reduce their wait time for results and revisits.  The new state-of-the-art facility is spread across 3150 square meters, and is equipped with bench-marked manufacturing facility and globally renowned processes and systems for Indian healthcare industry.   As a part of skill development initiative, the facility also serves as centre of excellence for training in laboratory diagnostics, point-of-care testing and diagnostic imaging, across South Asia region. The future ready site has a fully-functional PLM Lab set up for product development and validation.   The manufacturing unit comprises of two product lines namely urine strips; autopak biochemistry reagent and reagent grade water aqualab. From being pioneers in diagnostic manufacturing, Siemens Healthineers has maintained a high level of quality and reliability in diagnostics operations for over 40 years in India, and has been consistently tracking changes in consumer demands and met majority of consumer requirements in time. ]]> <![CDATA[Glenmark gets FDA nod of company’s first NDA for Ryaltris]]> https://biospectrumindia.com/news/95/11448/glenmark-gets-fda-nod-of-companys-first-nda-for-ryaltris.html https://biospectrumindia.com/news/95/11448/glenmark-gets-fda-nod-of-companys-first-nda-for-ryaltris.html Wed, 08 Aug 2018 15:35:00 +0530 Glenmark Pharmaceuticals announced that the U.S. Food & Drug Administration (FDA) has accepted for review the company's New Drug Application for its leading respiratory pipeline candidate Ryaltris™.   It is an investigational fixed-dose combination nasal spray of an antihistamine and a steroid, as a treatment for seasonal allergic rhinitis (SAR) in patients 12 years of age and older.   Ryaltris (olopatadine hydrochloride [665 mcg] and mometasone furoate [25 mcg]), formerly GSP 301 Nasal Spray, has been conditionally accepted by the FDA as the brand name.   The filing for Ryaltris includes efficacy and safety results from two pivotal, randomized, multicenter, double-blind, placebo-controlled trials in adults and adolescents 12 years of age and older with SAR.   The similarly designed trials lasted two weeks and enrolled 2,352 patients. Assessment of efficacy was based on patient-reported reflective total nasal symptom score (rTNSS), along with other patient-reported measures of nasal and ocular symptoms.   Across the two studies, treatment with Ryaltris resulted in statistically significant improvements in rTNSS compared to placebo.   ]]> <![CDATA[Suven Life Sciences Secures Product Patents In Mexico & NZ]]> https://biospectrumindia.com/news/95/11444/suven-life-sciences-secures-product-patents-in-mexico-nz.html https://biospectrumindia.com/news/95/11444/suven-life-sciences-secures-product-patents-in-mexico-nz.html Wed, 08 Aug 2018 12:40:00 +0530 Suven Life Sciences has announced grant of one product patent from Mexico and one product patent from New Zealand corresponding to the New Chemical Entities or the treatment of disorders associated with Neurodegenerative diseases and patents are valid through 2030 and2036 respectively. The granted claims of the patents include the class of selective H3 and 5-HT4 compounds respectively and are being developed as therapeutic agents for neurodegenerative disorders such as for the treatment of cognitive impairment associated with neurodegenerative disorders like Alzheimer’s disease, Attention deficient hyperactivity disorder (ADHD), Huntington’s disease, Parkinson and Schizophrenia and sleep disorders like Narcolepsy etc. “We are very pleased by the grant of these patents to Suven for our pipeline of molecules in CNS arena that are being developed for cognitive disorders with high unmet medical need with huge market potential globally” says Venkat Jasti, CEO of Suven.   ]]> <![CDATA[I-Mab Biopharma, MorphoSys declares China IND Submission of monoclonal antibody ]]> https://biospectrumindia.com/news/95/11443/i-mab-biopharma-morphosys-declares-china-ind-submission-of-monoclonal-antibody-.html https://biospectrumindia.com/news/95/11443/i-mab-biopharma-morphosys-declares-china-ind-submission-of-monoclonal-antibody-.html Wed, 08 Aug 2018 10:50:00 +0530 On August 8, 2018, Beijing time I-Mab Biopharma ("I-Mab"), a Shanghai-based biotech company focused on innovative biologics in oncology and autoimmune disease, and German biopharma company MorphoSys AG announced that I-Mab has Submitted an investigational new drug (IND) application to China National Drug Administration (CNDA) for TJ202/MOR202, a human monoclonal antibody directed against CD38 for the treatment of multiple myeloma.   TJ202/MOR202 is a monoclonal antibody derived from MorphoSys's HuCAL antibody technology. The antibody is directed against CD38 on the surface of multiple myeloma cells, and, according to its suggested mode of action, recruits cells of the body's immune system to kill the tumor. Scientific research suggests that an anti-CD38 antibody may have therapeutic potential in other cancers, as well as autoimmune diseases.   China recently issued a new round of reform initiatives to accelerate clinical trial approval for new drugs, especially in oncology. "The IND submission was done after a successful pre-submission consultation meeting with Center for Drug Evaluation (CDE) of CNDA, which is required under China's new drug regulation unless waived," said Dr. Joan Shen, Head of R&D at I-Mab.   "CNDA has endorsed the overall clinical and regulatory strategy, as well as the study designs, which should lead to the biologics license application (BLA)," said Dr. Joan Shen. Through a licensing agreement with MorphoSys AG in November 2017, I-Mab gained exclusive rights to develop and commercialize TJ202/MOR202 in Greater China territory, including mainland China, Hong Kong, Macau and Taiwan.   After observing patient responses in an interim analysis from an ongoing Phase I/IIa trial in patients with relapsed/refractory MM in Germany and Austria, MorphoSys decided to support I-Mab to lead clinical development of TJ202/MOR202 in Greater China. MorphoSys will continue to evaluate additional other suitable indications for further global development of TJ202/MOR202.     ]]> <![CDATA[Merck’s BioReliance services help to ensure purity, safety and efficacy]]> https://biospectrumindia.com/news/95/11442/mercks-bioreliance-services-help-to-ensure-purity-safety-and-efficacy.html https://biospectrumindia.com/news/95/11442/mercks-bioreliance-services-help-to-ensure-purity-safety-and-efficacy.html Tue, 07 Aug 2018 18:20:00 +0530 Merck has launched its BioReliance® Product Characterization Portfolio of tests for quality assessment of biologic drugs. This new, comprehensive suite of tests, provides critical information that biologic manufacturers need as they design their production process.      The purity, safety and efficacy of a drug must be identified and continuously monitored in order to support development and meet regulatory requirements necessary for commercialization. Manufacturers can better understand their molecule’s function, through comparison of structure and activity, helping them to make critical decisions.     This portfolio of assays enables the characterization of mAbs, including physicochemical and immunochemical properties, biological activity, stability, and purity as outlined in the ICH Q6B guidelines, as well as EMEA and FDA regulatory requirements. In addition, specialized capabilities, such as hydrogen-deuterium exchange technology and highly sensitive surface plasmon resonance instrumentation, are available. Merck’s experienced team is prepared for all testing needs, along with the ability for GMP validation as needed.     Merck provides the industry’s most comprehensive portfolio of high quality products, services, and testing for biopharmaceutical manufacturing. BioReliance® services offer risk-mitigating approaches, critical testing services and customized solutions to help bring life-changing therapies to market.     ]]> <![CDATA[Glenmark signs licence deal with Harbour BioMed ]]> https://biospectrumindia.com/news/95/11441/glenmark-signs-licence-deal-with-harbour-biomed-.html https://biospectrumindia.com/news/95/11441/glenmark-signs-licence-deal-with-harbour-biomed-.html Tue, 07 Aug 2018 11:45:00 +0530 Glenmark Pharmaceuticals S.A. and Harbour BioMed have entered into an exclusive license agreement for the Greater China territory to develop, manufacture and commercialize GBR 1302, Glenmark's bispecific antibody targeting HER2 and CD3 for the treatment of HER2-positive cancers. Under the terms of the agreement, Glenmark will receive an upfront payment and is eligible to receive payments for achieving pre-specified development, regulatory and commercialization milestones, as well as tiered royalties on net sales for any approved products from Harbour BioMed. The agreement is potentially worth more than $120 million in addition to royalties for Glenmark. Harbour BioMed will lead the clinical development and commercialization of GBR 1302, with the option to manufacture GBR 1302 for the Greater China market. The companies will collaborate on the generation of clinical data to support the registration of GBR 1302 in HER2-positive indications in their respective territories. GBR 1302, Glenmark's lead immuno-oncology candidate, works by stimulating the patient's immune system against HER2 overexpressing tumor cells. GBR 1302 is currently in a first-in-human study to determine the maximum tolerated dose (MTD) in an all-comers population of patients with a variety of HER2-positive cancers. Enrollment for the GBR 1302 clinical study is currently ongoing in the U.S. and Germany. ]]> <![CDATA[Cipla receives final approval for Diclofenac Sodium Topical Gel]]> https://biospectrumindia.com/news/95/11434/cipla-receives-final-approval-for-diclofenac-sodium-topical-gel.html https://biospectrumindia.com/news/95/11434/cipla-receives-final-approval-for-diclofenac-sodium-topical-gel.html Tue, 07 Aug 2018 10:10:00 +0530 Cipla Limited has announced that it has received final approval for its Abbreviated New Drug Application (ANDA) for Diclofenac Sodium Topical Gel, 1% from the United States Food and Drug Administration (US FDA). Cipla’s Diclofenac Sodium Topical Gel, 1% is AB-rated generic therapeutic equivalent to the reference listed drug (RLD), Voltaren Gel, 1% of GlaxoSmithKline Consumer Health. It is a non-steroidal anti-inflammatory drug indicated for the relief of the pain of osteoarthritis of joints amenable to topical treatment, such as the knees and those of the hands.According to IQVIA (IMS Health), Voltaren Gel and its generic equivalents had US sales of approximately $353M for the 12-month period ending June 2018. The product will be available for shipping in the US in the upcoming week. ]]> <![CDATA[DNAtix, Mapmygenome partner to advance personalized preventive medicine]]> https://biospectrumindia.com/news/95/11432/dnatix-mapmygenome-partner-to-advance-personalized-preventive-medicine.html https://biospectrumindia.com/news/95/11432/dnatix-mapmygenome-partner-to-advance-personalized-preventive-medicine.html Mon, 06 Aug 2018 13:20:00 +0530 Digital DNAtix Ltd., the blockchain genetics company, and Mapmygenome, a molecular diagnostics company has announced their alliance to advance cutting-edge, personalized and preventive medicine using blockchain technologies. The DNAtix genetics ecosystem links individual users in search of genetically-based health and lifestyle solutions with products and services that fit their needs. Mapmygenome offers a range of genetic tests and, as a provider on DNAtix’s growing genetic ecosystem, this collaboration will allow users to explore their genetic makeup in entirely new ways, with security and anonymity as a top priority. “India is an important market for the use of DNAtix blockchain-based genetic services, based on population numbers alone. Mapmygenome is a major player in the field of genetics and this partnership opens up a tremendous opportunity to help more people really utilize genetic testing and research,” said Ofer A. Lidsky, CEO of DNAtix. “Anyone can anonymously upload partial and/or full genome sequences onto the DNAtix platform; and then have access to to their genomic data which they can use to make informed decisions.” The DNAtix direct-to-consumer (D2C) platform provides full genome testing and access to services and solutions on the blockchain, and it allows researchers to use anonymous DNA stored on the DNAtix infrastructure to create tests, do research, and design new treatments. Mapmygenome will use DNAtix’s breakthrough infrastructure and working D2C genetic platform to provide in-depth analysis of full genome sequences with the speed, security and anonymity of blockchain technology. “We are quite excited about this partnership,” said Anu Acharya, CEO, Mapmygenome. “It opens doors to a much larger audience base, and adds another layer of security with the promise of blockchain in addition to our secure Lab Information Management Systems. By utilizing DNAtix’s blockchain-based platform for furthering the availability and accessibility to genomic services globally, we are taking yet another step towards empowering the masses with the promise of personal genomics – a doorway to preventive, predictive, personalized, precise medicine.” ]]> <![CDATA[Sun Pharma voluntarily recalls over 5.2k units of testosterone cypionate injections]]> https://biospectrumindia.com/news/95/11431/sun-pharma-voluntarily-recalls-over-5-2k-units-of-testosterone-cypionate-injections.html https://biospectrumindia.com/news/95/11431/sun-pharma-voluntarily-recalls-over-5-2k-units-of-testosterone-cypionate-injections.html Mon, 06 Aug 2018 13:05:00 +0530 The US arm of the domestic drug major Sun Pharmaceutical Industries is recalling over 5.2 thousand units of testosterone cypionate injections from the American market, the latest enforcement report of the US health regulator has said. Sun Pharmaceutical Industries Inc is recalling 5,215 units of 10 mL vials testosterone cypionate injections in the strength of 200 mg/mL, on account of "presence of particulate matter: organic and inorganic compounds detected in vials of product," the report said. The injections were manufactured by Sun Pharmaceutical Industries at its Halol facility, it added. As per the report by the United States Food and Drug Administration (USFDA), the ongoing voluntary nationwide recall is a class II recall. According to the US health regulator, a class II recall is initiated in a situation "in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote." The injections are indicated for replacement therapy in the male in conditions associated with symptoms of deficiency or absence of endogenous testosterone.   ]]> <![CDATA[Sanofi launches Aubagio for treatment of Multiple Sclerosis in India]]> https://biospectrumindia.com/news/95/11430/sanofi-launches-aubagio-for-treatment-of-multiple-sclerosis-in-india.html https://biospectrumindia.com/news/95/11430/sanofi-launches-aubagio-for-treatment-of-multiple-sclerosis-in-india.html Mon, 06 Aug 2018 12:00:00 +0530 Sanofi Genzyme, the specialty care global business unit of Sanofi, brings to India - Aubagio, from its international Multiple Sclerosis (MS) portfolio. A chronic and debilitating disease of the nervous system, Multiple Sclerosis has varied symptoms like weakness in the limbs, poor vision, fatigue or slurred speech. Aubagio (Teriflunomide, 14 mg) is the first original ‘once-daily’ oral ‘disease modifying therapy’ (DMT) for Multiple Sclerosis to be approved in India. It offers an effective, safe and a convenient option that is indicated as a first-line treatment for relapsing forms of Multiple Sclerosis that must be taken once a day, with or without food. Commenting on the launch, N. Rajaram, Managing Director, Sanofi India said, “There are around two lakh people living with this disease in India. Increasingly, new cases are being detected due to greater awareness and access to better diagnostic facilities. For over a decade Sanofi has invested in developing and delivering novel therapeutic solutions for treatment of Multiple Sclerosis around the world; and is now bringing Aubagio, our original research product to India.” He further added, “This product has the potential to offer an efficacious and convenient treatment regimen of just once a day oral tablet, vis-à-vis commonly available injectable treatment options. With Aubagio, we reaffirm Sanofi Genzyme’s commitment to improve and empower the lives of people with debilitating diseases in India.” Dr. Shalini Menon, Country Medical Director, South Asia, Sanofi said, “Aubagio is a differentiated disease modifying therapy, that blocks the enzyme involved in multiplication of overactive immune cells. When taken daily, Aubagio reduces the number of overactive immune cells that cause the disease flare-ups, while still allowing normal immune cell activity to occur. It is important to note that Aubagio has demonstrated consistent efficacy in reducing the frequency of relapses, delaying the progression of physical disability and, arresting further decrease in brain volume. In addition, since Aubagio is an oral medicine, people with Multiple Sclerosis will find it very convenient and can continue with long-term treatment.” First approved by the US FDA in 2012, Aubagio has a strong global presence today with approvals in more than 81 countries. It has been extensively studied in >5,500 patients with up to 13 years of clinical and follow-up studies with proven clinical efficacy, safety and tolerability outcomes. Globally, >85,000 patients with Multiple Sclerosis are benefitting from the use of Aubagio. ]]> <![CDATA[Lindström launches India’s first cleanroom unit in Pune ]]> https://biospectrumindia.com/news/95/11427/lindstrm-launches-indias-first-cleanroom-unit-in-pune-.html https://biospectrumindia.com/news/95/11427/lindstrm-launches-indias-first-cleanroom-unit-in-pune-.html Mon, 06 Aug 2018 10:55:00 +0530 Lindström India, a 100% subsidiary of the Finnish Lindström Oy launched its second line of business, called Cleanroom services in India to ensure the highest quality, hygiene, safety and reliability which is most critical to customers in the pharmaceutical, food and electronics industry. Lindström’s cleanroom service ensures hygienic production facilities by providing garments serviced in cleanroom laundries which prevent contaminations during process hereby ensuring complete safety of the products being manufactured. The cleanroom unit, spread over 50,000 square feet has a capacity of servicing 400,000 numbers of uniforms per month. The staff in the unit has received special training from experts in Finland and operates under classified cleanroom environment to guarantee the supply of particle free and contamination free garments to its customers. Inaugurating the new unit in Chakan in Pune, Dr. Suresh Jadhav, Executive Director, Serum Institute of India Pvt. Ltd. said, “We’re very excited about the launch of Lindström’s first cleanroom unit for us. We have been working with Lindström for the last two years on this project and see huge value in the professional workwear services they offer. The Cleanroom Unit is a huge step in our mission of conforming to the highest industry standards and our commitment to quality.” ]]> <![CDATA[Mankind Pharma launches KABZEND to prevent constipation]]> https://biospectrumindia.com/news/95/11420/mankind-pharma-launches-kabzend-to-prevent-constipation.html https://biospectrumindia.com/news/95/11420/mankind-pharma-launches-kabzend-to-prevent-constipation.html Fri, 03 Aug 2018 11:25:00 +0530 Mankind Pharma, a quality-driven pharmaceutical company in India has launched a new Over-the-counter (OTC) product, ‘KABZEND Natural Laxative Granules’ to help relieve constipation. Mankind Pharma has chosen Veteran Actor Rishi Kapoor as the brand ambassador of its new product. KABZEND is an Ayurvedic-based formulation that will help maintain regular bowel movements and ensure proper cleansing of the body which is available in trendy 50g bottle packaging. KABZEND is a blend of time-tested potent & quality herbs to effectively pacify the problems leading to gastrointestinal disorders such as constipation, indigestion, gas and irregular bowel syndrome. Herbs used in the formulation of KABZEND are undertaken with intense care and good manufacturing guidelines to ensure quality standards, making it safe for consumption. Inspired by Pradhan Mantri Jan Aushadi Scheme to deliver pharmaceuticals products at affordable prices, Mankind Pharma with its Make in India approach has set up goals to sustain a balance in the healthcare of the country. ]]> <![CDATA[Agilent Technologies concludes acquisition of ProZyme]]> https://biospectrumindia.com/news/95/11414/agilent-technologies-concludes-acquisition-of-prozyme.html https://biospectrumindia.com/news/95/11414/agilent-technologies-concludes-acquisition-of-prozyme.html Thu, 02 Aug 2018 17:15:00 +0530 Agilent Technologies has completed the acquisition of ProZyme, Inc., a leading provider of glycan reagents, kits and standards. This acquisition expands Agilent’s portfolio of biopharma consumables.   Founded in 1990, Hayward-Calif. based ProZyme is an industry leading developer and manufacturer of glycan reagents, kits and standards, which are required for efficient sample prep in the analysis of free glycans.   Glycobiology is one of the fastest-growing segments in biopharma, as glycans play diverse roles in biotherapeutics, novel drug development, the study of bacterial physiology, and proteomics research.   The acquisition of ProZyme follows the recent acquisition of Ultra Scientific, a leading provider of chemical standards and certified reference materials. ]]> <![CDATA[Hyderabad to witness latest pharma innovations and trends with PharmaLytica 2018]]> https://biospectrumindia.com/news/95/11403/hyderabad-to-witness-latest-pharma-innovations-and-trends-with-pharmalytica-2018.html https://biospectrumindia.com/news/95/11403/hyderabad-to-witness-latest-pharma-innovations-and-trends-with-pharmalytica-2018.html Wed, 01 Aug 2018 11:35:00 +0530 UBM India, organizers of CPhI / P-MEC India, the leading global pharma trade show and conference, has announced the 5th edition of PharmaLytica 2018. The two-day event will be held at Hyderabad, the Bulk Drug capital of India, at the HITEX Exhibition Center on 10th & 11thAugust 2018. The most important pharma related expo in South India, PharmaLytica 2018 will enable the pharmaceutical community pick up on the latest industry trends, innovations and conduct business with Analytical, Laboratory, Machinery, Packaging and other allied Industries. The expo is well supported by associations including Pharmexcil, Confederation of Indian Pharmaceutical Industry (CiPi) and Indian Drug Manufacturers’ Association ( IDMA ). In the current edition, PharmaLytica will witness the participation of over 150 exhibitors from across the country including notable industry players such as Kirloskar, Standard Group of Companies, Bry-Air Asia, Allyone Industries, Rotomark Innovations, Gandhi Automation, Mack Pharmatech, Autocal Solutions, Helios Concrew, S.K. Pharma Machinery, NPM Machinery, GMM Pfaudler, ELGI Equipments, First Source Lab, Apex Chromatography, Valfit Engineers, Integrated Cleanroom Technology,  Dumra Machines, Sigma Scientific Glass, among many others. The event also comprises the PharmaLytica Seminar, covering a number of insightful sessions and discussions on the latest industry trends. Some of these include subjects such as ‘A Smart Pharma Manufacturing for Operational Excellence; Latest in Pharmaceutical, Analytical & Lab’ ; ‘Technology Edge’ that will talk about the Importance of information in the pharmaceutical industry; ‘Cost-Quality Efficiency’; ‘Setting Quality Culture Parameters’ that will talk about challenges pertaining to quality culture articulation; ‘A distant view of Indian Pricing & Regulatory: US Perspective’; ‘Presentation of Case study on Pharmacoeconomics’; ‘Is Regulatory Compliance much more than good manufacturing Practices (GMP)?’and  ‘Regulatory, Pricing & Patients – Equilibrium. The expo plans to spread out its wings in 2019 by venturing into the Western region with its strong pharma market by hosting PharmaLytica for the first time in Mumbai. While targeting the South-West market with sectors such as Lab & Analytical, Pharma Machinery & Packaging , PharmaLytica will also launch API and Excipients zone to continue its pre-eminence in this region. This will enhance the exhibition profile as a one stop shop for all end-to-end Pharma solutions under one roof. Speaking on the announcement of the 5th edition of PharmaLytica, Mr. Yogesh Mudras, Managing Director, UBM India said, “Over the years, PharmaLytica has evolved as the leading marketplace for products and services along the entire value chain in niche segments within the Pharma industry. The expo and especially the conference within it, seeks to deepen understanding of the changing landscape in the sector to enable responses to marketplace trends. It will also play a key role in establishing a unique drug safety ecosystem in India”. “By 2020, India is likely to be among the top three pharmaceutical markets by incremental growth and 6th largest market globally in absolute size. The pharma companies are making tremendous efforts to discover new drugs, increasing R&D expenditure, implementing technology and introducing new methodologies to improve quality of manufacturing. Our focus at PharmaLytica, would be to keep the companies abreast with innovations in the growing businesses of India’s pharma industry. Given our growing and unrivalled offering in the pharma domain, and the fact that the expo has been growing in tandem with the growth of the sector including in the ancillary side, we are pleased to move PharmaLytica to Mumbai in 2019. Side by side, we are also increasing our offerings and this will no doubt, add immense value to the strong Western market in addition to the Southern one.” he further added. Renowned as the pharmacy of the world, the Indian pharma economy has been lauded for its rapid growth in recent decades. The pharmaceutical sector was valued at $ 33 billion in 2017. The country’s pharmaceutical industry is expected to expand at a CAGR of 22.4 per cent over 2015–20 to reach US$ 55 billion. India’s pharmaceutical exports stood at $ 17.27 billion in 2017-18 and are expected to reach US$ 20 billion by 2020. The various economic drivers and government policies like pharma parks, boosting the biosimilars and biologics sector, along with ancillary sectors, and reducing manufacturing costs are the key driving factors for the growth of the sector in the country. The ‘Pharma Vision 2020', introduced to make India a global leader in end-to-end drug manufacturing, has also boosted investments. ]]> <![CDATA[Biocon aims $200M revenue from biosimilars]]> https://biospectrumindia.com/news/95/11401/biocon-aims-200m-revenue-from-biosimilars.html https://biospectrumindia.com/news/95/11401/biocon-aims-200m-revenue-from-biosimilars.html Wed, 01 Aug 2018 11:15:00 +0530 Bengaluru-based Biotechnology firm, Biocon is targeting to register a 66 per cent growth in its biologics business this fiscal, which the company hopes will help it clock revenue of $200 million on the back of emerging markets growth.   Its current revenue from the biosimilars market is around $120 million. In the last six months, the company (along with its partner Mylan) has made significant progress on the regulatory front in the US and EU markets and has built a biosimilars pipeline.   However, it is still some time away for these markets to drive growth. The company feels that developed markets would drive revenue growth in the next three years.   Building on its India experience, the firm has been unlocking value in other emerging markets with Recombinant Human Insulin (rh-insulin), which has already been approved in 60 countries. The approval of Mylan and Biocon’s biosimilar insulin Glargine in about 25 countries will also be a revenue-driving force.   Besides expansion of territories, another factor that will help the company meet the $200 million target is the integrated insulins manufacturing facility in Malaysia which has got regulatory approvals from various emerging markets.    In the first quarter of this financial year, the biologics segment recorded a revenue growth of 36 per cent at Rs 2.5 billion. This came on the back of biosimilar sales as Biocon’s novels such as the oral insulin are still a long way from commercialisation.   Another driver for growth will be biosimilar Trastuzumab, used for the treatment of breast and stomach cancer. It witnessed a strong retail market uptake in Brazil, one of the top four emerging markets for this drug globally. It is gaining traction in other emerging markets, according to the company.   Biocon feels new launches in the developed world will drive the company’s revenue only in the next three years.   The company has made several inroads into the developed markets on the back of biosimilars. Fulphila, co-developed by Biocon and Mylan, became the first biosimilar to pegfilgrastim being approved in the US.   It has a huge market base as pegfilgrastim innovator Amgen’s Neulasta has an annual global sales of $4.7 billion out of which $3.9 billion is generated from the US alone. Oncology biosimilar Trastuzumab has also been given USFDA approval.   It is also currently under regulatory review in geographies such as European Union and Australia. There are also plans to launch Insulin Glargine in Europe and Australia later in the year. Glargine has already been commercialised in Japan. ]]> <![CDATA[Vanta Bioscience to foray into clinical research business]]> https://biospectrumindia.com/news/95/11400/vanta-bioscience-to-foray-into-clinical-research-business.html https://biospectrumindia.com/news/95/11400/vanta-bioscience-to-foray-into-clinical-research-business.html Wed, 01 Aug 2018 11:10:00 +0530 Hyderabad-based Vanta Bioscience which provides pre-clinical services has announced its foray into clinical research. Further to this, the Board of Vanta Bioscience has approved incorporation of a 100% subsidiary in the name of Vanta Clinical Research at Hyderabad. Additionally, the Board has also approved incorporation of a 51% step down subsidiary of the above mentioned company in the name of Vanta Research Solutions at Hyderabad. The company has said in a statement that the clinical research business will begin contributing to the topline in the last quarter of the current financial year. The company is projecting to add revenue of Rs. 250 crore in the fifth year through clinical research services. Vanta Bioscience is an emerging, full service preclinical contract research organization, headquartered in the USA and operating out of Chennai, India. Vanta Bioscience is established as a center of excellence for GLP toxicology and safety assessment. It is housed in a new, 56,000 square foot state-of-the-art facility specifically designed for compliance with GLP and AAALAC international guidelines for humane care and use of small animal species involved in Vanta Bioscience studies. The facility is registered with the CPCSEA, Govt. of India and has acquired the OECD GLP Accreditation from the National GLP Monitoring Authority of India, in addition to the AAALAC International Accreditation, joining an elite group of facilities in India. AAALAC certification is valued as the gold standard for animal care and use.  ]]> <![CDATA[Digital Mammography Equipment Introduced In Karnataka]]> https://biospectrumindia.com/news/95/11395/digital-mammography-equipment-introduced-in-karnataka.html https://biospectrumindia.com/news/95/11395/digital-mammography-equipment-introduced-in-karnataka.html Tue, 31 Jul 2018 13:25:00 +0530 Breast cancer is one of the most common cancers affecting Indian women and early diagnosis of the disease is imperative for better survival rate. Bearing this important thought in mind Trivitron Healthcare in association with Bangalore Baptist Hospital have introduced the 3D Tomosynthesis and Stereotactic guided Vacuum assisted Biopsy system which will be the most advanced digital mammography equipment in Karnataka. 3D Tomosynthesis is an advanced technology which takes less than 4 seconds to scan any abnormality in the breast. Studies have shown that the chances for successful treatment are nearly 100 per cent if breast cancer is detected early. 3D Tomosynthesis removes overlapping, increases lesion visibility, helps to localize structures, reduces repeat studies, helps to detect cancer and improves the quality of patient care with painless mammogram procedures. The accuracy of breast cancer detection through the usage of 3D Tomosynthesis has been incrementally high at 40 percent better detection when compared to 2D mammogram. Complimenting on the inauguration, Mr. R Sampath Raj, the Honourable Mayor of Bangalore said, ‘My hearty congratulations to Bangalore Baptist Hospital for bringing first of its kind advanced 3D Digital Mammography technology to Bangalore. Across the world, breast cancer is the No.1 cause of cancer death in women. Early detection of breast cancer is the key to save lives. My humble request to all women above 40 years is to get their annual mammogram screening done as this will help them to detect breast cancer at an early stage.’ Addressing his thoughts about the innovation, Dr. Naveen Thomas Director, Baptist Hospital said, ‘Bangalore Baptist Hospital is committed to fight breast cancer with world-class technologies and we now have the first of its kind advanced digital mammography equipment in Karnataka with 3D Tomosynthesis technology and stereotactic guided vacuum assisted biopsy. The advanced 3D Tomosynthesis technology removes the overlapping structures and increases the lesion visibility allowing the clinicians to pick up cancer at a very early stage.  The stereotactic guided vacuum assisted biopsy system helps in localizing and removing the lesion completely resulting in therapeutic treatment as well. The entire procedure is painless and improves the overall patient care. We now have a world-class comprehensive breast care centre in Bangalore that will benefit the people of Karnataka.’ Commenting on this initiative, Mr. M Brahadeesh, President – Imaging, Trivitron Healthcare said, ‘Trivitron is committed to reduce the breast cancer deaths in India by improving mammography penetration in both urban and rural locations. Selenia Dimensions with 3D Tomosynthesis which is installed at Baptist Hospital, Bangalore is the most advanced 3D Digital Mammography equipment available in Karnataka as of now. The time taken for a Tomosynthesis scan will be less than 4 Seconds. We are proud to be associated with Baptist Hospital and are certain that this advanced mammography technology will save many lives in the coming years. ]]> <![CDATA[Biocon to focus on innovative therapy for Head & Neck cancer in India ]]> https://biospectrumindia.com/news/95/11393/biocon-to-focus-on-innovative-therapy-for-head-neck-cancer-in-india-.html https://biospectrumindia.com/news/95/11393/biocon-to-focus-on-innovative-therapy-for-head-neck-cancer-in-india-.html Tue, 31 Jul 2018 11:55:00 +0530 Biocon Ltd., Asia's premier biopharmaceuticals company, organized a scientific session and a panel discussion on Creating a paradigm shift in patient outcomes in cancer treatment through innovative targeted therapies. A panel of leading Oncologists focused on the evolution of cancer care treatment in India and highlighted the role of Biosimilars and Biologics in driving newer standards of testing and care in the country. In particular, the discussion focused on targeted therapies in Head and Neck Cancer, including the usage of Biocon’s novel Biologic – BioMab EGFR (Nimotuzumab). The discussion saw an exchange of views from an august panel of senior specialists: Dr. G K Rath, Head, National Cancer Institute, AIIMS;  Dr. Harit Chaturvedi, Director of Surgical Oncology, Max Super Speciality Hospital, Saket; Dr. Kumar Prabash, Professor & Head Solid Unit, Medical Oncology, Tata Memorial Hospital; Dr Shyam Aggarwal, Senior Consultant, Medical Oncology, Sir Ganga Ram Hospital; Dr Vijay Anand Reddy, Senior Consultant - Clinical Oncology & Radiotherapy at Apollo Health City; Dr Sumit Goyal, Senior Consultant, Department of Medical Oncology at RGCI; Dr. Atul Sharma, Professor, Medical Oncology, IRCH, AIIMS. The panellists agreed that “Developments focused on accuracy and precision have improved quality of life for cancer patients. Dependence on targeted therapies proves that drugs specifically designed to target tumour cells, offer better efficacy, safety and tolerability and may eventually become the standard of care, bringing a paradigm shift in cancer management.” Head and neck cancers are a significant problem in our country constituting approximately one-third of all cancer cases, in contrast to 4-5% in the developed world.  Paradoxically, however, management of these cancers is dictated by guidelines emanating from the West, with just a handful of seminal publications from India. Hence, there is a necessity to bring to the fore, novel treatments and interventions that address disease management and cure in the Indian context. Against this backdrop, Biocon had developed a novel biologic in early 2000’s and launched in India, its flagship Oncology Product BioMab EGFR (Nimotuzamab) for Head and Neck Cancer in 2006. The product has made a difference to several thousand patients so far and a new large scale investigator-led randomized clinical study at Tata Memorial Hospital   has demonstrated the superior profile of this therapy leading to better patient outcomes for head and neck cancer patients.  Conducted with 536 patients from Tata Memorial Hospital, the results of this study, which were recently presented at the annual conference of the American Society of Clinical Oncologists (ASCO), evaluated the efficacy and safety of administering Nimotuzumab. Among the largest randomized clinical studies on head and neck cancer, it proved how the introduction of this molecule, to the existing standard of care in patients of Head and Neck cancer, dramatically improved treatment outcomes on factors like progression-free survival, disease-free survival, duration of loco-regional control and overall survival. Till now the main management of Head and Neck Cancer was Chemotherapy + Radiation therapy however this study opens up a new improved way of manging Locally Advanced Head and Neck Cancer as it will now allow clinicians to add Biomab ( Nimotuzumab ) which is a targetedtherapy to the current standard of Care (CRT). Biomab has a unique bivalent binding, because of which it binds primarily at the site of cancer cells where there is over expression of the EGFR protein. This is significant since this mechanism of action of Biomab ensures that only the cancerous cells are destroyed, unlike other targeted agents, ensuring that it does not cause additional toxicity.   Key results of the study:   Improvement in median progression free survival by almost three times: Patients who were administered Biomab along with the usual chemo – radiation therapy, had survived without the disease progressing for almost three times more than patients who were only administered chemo-radiation.   Reduction in risk of disease progression by 26%   Reduction in grade 3-5 adverse events (except mucositis): This led to better compliance in the study, with no patient drop off due to severe side effects   Significant improvement in Loco-regional control and disease free survival: Which means that further growth of tumour may get arrested     In an additional scientific meeting of Oncologists at Chennai, 50% of the oncologists in attendance suggested said that these results are practice changing and they will like to add Nimotuzumab to current standard of Care (CRT) to all their patients of locally advanced Head and Neck Cancer. Suresh Subramanian, Senior Vice President & Head, Branded Formulations business – India and South Asia, Biocon said “As the first company in India to successfully introduce a novel targeted anti-EGFR biologic, for the treatment of head and neck cancers, the positive results from this large randomized study are a significant milestone in our ongoing efforts to establish Nimotuzumab’s ‘best-in-class’ status for the treatment of one of the most common forms of cancer in the country. We are pleased with the global recognition of the superior efficacy and safety profile of Nimotuzamab and the difference it can make in improving clinical outcomes of head and neck cancer patients by its addition to the standard of care. ” Biocon has been in the forefront of a long-running crusade against cancer. India’s first indigenously manufactured novel biologic Nimotuzumab (BIOMAb EGFR®) was Biocon’s first effort at providing an affordable therapy to patients in India. As India’s leading Oncology Company, Biocon has already introduced several anti-cancer therapies, ranging from premium generics to biosimilars and novel biologics, for the benefit of patients, caregivers and medical practitioners in the country. Biocon’s portfolio of therapies covers a wide range of cancer sites across head and neck, breast, colorectum, ovary, cervix, kidney, brain and lungs, as well as, supportive therapy. Through its niche portfolio of oncology therapeutics, Biocon has been able to make a significant impact in the area of cancer care in India. In addition to novel biologics, Biocon is addressing a large unmet need for advanced cancer medicines in India through high quality, affordable biosimilars that provide cost-effective alternatives to expensive reference biologics. Beyond medicines, Biocon has adopted a 360-degree strategy which involves establishing the scientific concept of a therapy through science symposia and advisory boards; generating scientific data through investigator-initiated studies and then publishing the results in reputed journals to build prescriber confidence; creating disease awareness through campaigns, free diagnostic consultations and referral meets; and patient assistance programs involving part therapy assistance and patient counselling helplines.  Biocon also conducts 'Converge', an international summit for tumor specific discussions focused on breast and head & neck cancer. Biocon’s CSR arm, Biocon Foundation, implements several technology-based interventions for early detection, prevention and treatment of cancer. We organise screening camps for the underprivileged in rural and semi-urban India, thus facilitating early detection at the doorstep. By empowering frontline health workers to conduct cancer screening in a low resource settings, Biocon Foundation has ensured that these services reach remote pockets in a cost-effective manner. Through its flagship cancer detection program, the Foundation has screened over 53,000 men and women for oral, breast and cervical cancers till date. Patients with potential risk have been supported to undergo further evaluation. In a developing country like India, innovations enabling cheaper drugs and early diagnosis can work wonders in cancer care. Biocon has carved out its own path keeping in view India’s healthcare challenges, and with the realization that without affordability medicines would not reach patients. Our cancer therapies developed on this philosophy – from supportive care and cytotoxic drugs to biosimilar antibodies and novel molecules – have made an enduring impact on the lives of thousands of cancer patients in India. ]]> <![CDATA[Lupin gets EDQM nod for its Mandideep facility]]> https://biospectrumindia.com/news/95/11385/lupin-gets-edqm-nod-for-its-mandideep-facility.html https://biospectrumindia.com/news/95/11385/lupin-gets-edqm-nod-for-its-mandideep-facility.html Mon, 30 Jul 2018 14:25:00 +0530 Drug firm Lupin has said that it has received attestation from European Directorate for the Quality of Medicines (EDQM) for its Mandideep facility in Madhya Pradesh. The unit was inspected by EDQM in March this year. "The inspection was focused on the application for certificate of suitability for the dossier of Cefaclor along with facility inspection for Quality Management Systems based on cGMP as laid under European Union rules governing medicinal products," according to the company. Lupin MD Nilesh Gupta said: "We are happy to receive the EDQM attestation for our Mandideep facility." Over the past few months, Lupin has continued to drive multiple initiatives to further strengthen manufacturing standards and best practices to be amongst the best, he added. ]]> <![CDATA[Wockhardt starts manufacturing and R&D facility in Dubai]]> https://biospectrumindia.com/news/95/11381/wockhardt-starts-manufacturing-and-rd-facility-in-dubai.html https://biospectrumindia.com/news/95/11381/wockhardt-starts-manufacturing-and-rd-facility-in-dubai.html Mon, 30 Jul 2018 11:30:00 +0530 Wockhardt, an India-based pharmaceutical company and Biotech major, sets up its first facility in Middle East for manufacturing of NCEs (New Chemical Entities) catering to the global markets through its Dubai arm of its subsidiary Wockhardt Bio AG.   With an aim to grow and further establish their international presence in pharmaceutical manufacturing, Wockhardt inaugurated a ‘state-of-the-art’ manufacturing facility for the production and packaging of sterile dry powder injection in Dubai. On approval of the new drug by US FDA, this manufacturing facility will be commissioned for commercial production.   Antimicrobial resistance (AMR) the ability of infections to resist antibiotics to work against it is increasingly recognized as growing global health problem. Infections caused by antimicrobial resistant strains of bacteria-also called “superbugs” are unlikely to respond to standard treatments resulting in prolonged illness and a greater risk to health, and severely impacting clinical outcomes, leading to further higher healthcare costs due to consumption of healthcare resources.   Wockhardt currently has 5 novel antibiotic drugs in advanced stages of global clinical development which will be effective against these “superbugs” threats identified by the Center of Disease Control, USA. Considering the strategic importance of these antibiotics, the US FDA has granted Qualified Infectious Disease Program (QIDP) status to the 5 novel antibiotic drugs.   Wockhardt Bio AG manufacturing facility is designed to meet standards of various international regulatory agencies and the standards as set by the Local Ministry of Health. The facility meets the needs of Aseptic Dry Powder Injectable manufacturing and filling with a high quality operation. This facility is dedicated to launch its novel New Chemical Entities in the Antibiotics segment to the world from UAE.   The facility is spread over 10,000 sq. meters of space, self-sufficient for handling Warehousing, Manufacturing Operations, Product Testing and Product Stability.   The facility is equipped with best-in-class and fully automated manufacturing equipment and clean utility systems. The design takes into account the requirements for Product & Personnel Safety and Product Quality with complete close transfers and high levels of sterility assurances.   ]]> <![CDATA[Sanofi Pasteur launches FluQuadri vaccine in India]]> https://biospectrumindia.com/news/95/11374/sanofi-pasteur-launches-fluquadri-vaccine-in-india.html https://biospectrumindia.com/news/95/11374/sanofi-pasteur-launches-fluquadri-vaccine-in-india.html Fri, 27 Jul 2018 12:05:00 +0530 Sanofi Pasteur, the vaccine division of Sanofi, recently announced the launch of its 4-strain influenza vaccine FluQuadri® in India. FluQuadri® will be India’s first quadrivalent vaccine to provide broader protection against influenza to population above 3 years of age. Currently, the majority of seasonal influenza vaccines are trivalent, meaning that they protect against: two A strains and one single B lineage (B/Victoria or B/Yamagata) of Influenza virus. However, over the recent flu seasons, co-circulation of both B lineages has been consistently observed, making it difficult for the World Health Organization (WHO) to recommend which B strain should be incorporated in trivalent influenza vaccines. Given the change in epidemiology, quadrivalent vaccination represent the next logical step to an advanced level of protection. The WHO includes quadrivalent influenza vaccines in its recommendations, stating “Quadrivalent influenza vaccines that could potentially provide wider protection against influenza B viruses are becoming available and recommendations should not be limited to trivalent vaccine.” Dr. Vijay Yewale, Director & Consultant Pediatrician, Dr.Yewale’s Multispecialty Hospital, Navi Mumbai; and Head, ICH, Apollo Hospitals, Navi Mumbai said, “There are 2 different subtypes of influenza type B causing disease in human. The vaccine available until now includes only one of the influence B subtypes and thus protects against only against the one included in the vaccine. The influenza vaccine is freshly prepared twice in a year and influenza viruses types, both A and B are included in the vaccine based on the scientific prediction made about the types likely to circulate in the year. In the decade between 2000 and 2010, 50 % of the times in Europe and USA the disease causing B subtype in circulation was different from the one included in the vaccine. This would leave vaccinated individuals unprotected against the subtype that’s not included in the vaccine. A quadrivalent vaccine offers protection against all four subtypes – two Influenza B and the two Influenza A subtypes. This protects them against all the circulating subtypes.” India has also seen circulation of type B influenza strains. The IDSP (Integrated Disease Surveillance Program) annual report 2017 stated that in the wake of high number of influenza deaths and cases in Gujarat, an expert committee noted that one of the main reasons of flu epidemic in Gujrat was that during last year, the H3N2 and B subtypes of influenza virus were circulating, but not H1N1, leading to a build-up of the susceptible population. As a result, the committee has suggested that in future, in all IEC (Information Education Communication) material the words “swine flu” to be replaced by the words “seasonal flu” and all references to H1N1 be omitted. In another instance, a surveillance project for acute febrile illnesses, anchored at the Manipal Centre for Virus Research in Karnataka, found that influenza accounts for nearly 20% of fevers across rural areas in 10 Indian States and during the years when the H1N1 burden is low in these regions, H3N2 and Influenza B circulation tends to spike. “Sanofi Pasteur remains at the forefront of innovation to fight the underestimated burden of influenza. Our 60+ years of expertise in influenza prevention inspires us to pursue better vaccine solutions to combat the burden of the disease. We are proud to bring this innovation to India, which has seen quite a few influenza epidemics in the past decade. By making FluQuadri® available to the Indian population, we aim to provide broader protection for people 3 years of age and older against this severe disease and its potentially life-threatening complications”, said Jean-Pierre Baylet, Country Head – Sanofi Pasteur South Asia. ]]> <![CDATA[Dr. Reddy's Laboratories Announces the Launch Of Trastuzumab Biosimilar In India]]> https://biospectrumindia.com/news/95/11371/dr-reddys-laboratories-announces-the-launch-of-trastuzumab-biosimilar-in-india.html https://biospectrumindia.com/news/95/11371/dr-reddys-laboratories-announces-the-launch-of-trastuzumab-biosimilar-in-india.html Thu, 26 Jul 2018 14:25:00 +0530 Dr. Reddy’s Laboratories Ltd. has announced that it has launched Hervycta (trastuzumab), a biosimilar of Roche’s Herceptin, in India, indicated for the treatment of HER2-positive cancers (early breast cancer, metastatic breast cancer, and metastatic gastric cancer). Dr. Reddy’s Hervycta is available in strengths of 150mg and 440mg multiple dose vials. Commenting on the launch, MV Ramana, CEO-Branded Markets (India and Emerging Markets), Dr. Reddy’s Laboratories, said, “We strive every day to do what matters most for patients. Hervycta is a step forward in our effort to accelerate access to cancer patients in India, in the Oncology biosimilar space.” Dr. Raymond De Vré, Senior Vice President and Head, Biologics, Dr. Reddy’s Laboratories, added, “The launch of Hervycta will immensely benefit women in India who are suffering from HER2-positive breast cancer and are in need of access to high quality, affordable and innovative medicines.” Herceptin, marketed as Herclon in India and its biosimilars had India sales of approximately INR 290 Crore MAT for the most recent twelve months ending in December 2017, according to Ipsos*. Dr. Reddy’s currently has four biosimilar products commercialized in India and various emerging markets, and an active pipeline of several biosimilar products in the oncology and immunology space. *Ipsos India Tandem Oncology Monitor 2017 ]]> <![CDATA[Glenmark Pharma announces positive Results of GBR 310]]> https://biospectrumindia.com/news/95/11369/glenmark-pharma-announces-positive-results-of-gbr-310.html https://biospectrumindia.com/news/95/11369/glenmark-pharma-announces-positive-results-of-gbr-310.html Thu, 26 Jul 2018 13:30:00 +0530 Glenmark Pharmaceuticals, a global pharmaceutical company announced results from a Phase 1 study that suggest similarity in pharmacokinetic, pharmacodynamic, safety and immunogenicity profiles between Glenmark's GBR 310 proposed biosimilar and reference product omalizumab, marketed in the U.S. under the brand name Xolair®.   GBR 310 is a recombinant DNA-derived humanized immunoglobulin G1 kappa monoclonal antibody. The proposed indications for GBR 310 are for the treatment of allergic asthma and chronic idiopathic urticaria (CIU).   The now completed Phase 1 study enrolled 168 healthy adult volunteers, randomized 1:1 to receive either a single 150 mg dose of GBR 310 subcutaneously (SC) or a single 150 mg dose of U.S.-sourced omalizumab SC. The total duration of participation for each volunteer was approximately 127 days, including screening, in-house stay, outpatient and follow-up visits.   According to IQVIA sales data for the 12-month period ending May 2018, annual sales of Xolair were approximately $2.0 billion in the U.S. ]]> <![CDATA[LANXESS India incumbent MD Neelanjan Banerjee to lead India region]]> https://biospectrumindia.com/news/95/11366/lanxess-india-incumbent-md-neelanjan-banerjee-to-lead-india-region.html https://biospectrumindia.com/news/95/11366/lanxess-india-incumbent-md-neelanjan-banerjee-to-lead-india-region.html Thu, 26 Jul 2018 11:15:00 +0530 German specialty chemicals company LANXESS is establishing a new regional structure which will comprise the regions EMEA (Europe, Middle East and Africa), Americas (North and South America), APAC (Asia-Pacific) and India for enhanced focus and growth in the new regions.   As part of the new organization, the newly formed India region will be headed by the then LANXESS India Managing Director & Country Representative, Neelanjan Banerjee starting September 1, 2018.   He will undertake these tasks in addition to his current function as head of the Advanced Industrial Intermediates business unit (BU AII) in India. Banerjee joined LANXESS in 2006 as head of the former Basic Chemicals business unit and the Saltigo business unit in India.   ]]> <![CDATA[Kilitch Drugs hires V.S. Rajan, Prof. V.K Murti to the Board]]> https://biospectrumindia.com/news/95/11364/kilitch-drugs-hires-v-s-rajan-prof-v-k-murti-to-the-board.html https://biospectrumindia.com/news/95/11364/kilitch-drugs-hires-v-s-rajan-prof-v-k-murti-to-the-board.html Wed, 25 Jul 2018 17:20:00 +0530 The Board of Directors of Kilitch Drugs Ltd announced the appointment of Mr. V.S. Rajan and Prof. V.K Murti as Independent Non-executive Directors.   Mr.  Mukund P Mehta, Managing Director, Kilitch Drugs Ltd said, “We welcome Mr. Rajan and Prof. Murti to the Board. Both bring rich experience in the field of pharmaceuticals and organisational development. Their support and guidance will be of great value as Kilitch prepares to chart a new growth agenda.”   V.S. Rajan has been in executive roles with companies such as Pfizer India, Warner Hindustan, Anamed Instruments, among others. He holds a Business Management Degree and a Masters in Marketing.   Prof. V K Murti is an adviser to many owner managed companies and is also on the Board of Gem & Jewellery Skill Council of India. He is a faculty member at S P Jain Institute of Management & Research.     ]]> <![CDATA[Sun Pharma brings generic Glumetza tablets in US market]]> https://biospectrumindia.com/news/95/11362/sun-pharma-brings-generic-glumetza-tablets-in-us-market.html https://biospectrumindia.com/news/95/11362/sun-pharma-brings-generic-glumetza-tablets-in-us-market.html Wed, 25 Jul 2018 15:45:00 +0530 Sun Pharmaceutical Industries said one of its wholly owned subsidiaries has launched generic metformin hydrochloride extended release tablets, used for glycemic control, in the US market.   The tablets have been launched in the strengths of 500 mg and 1000 mg.   The tablets are generic versions of Santarus Inc's Glumetza HCl extended release tablets in the same strengths, it added.   "The addressable market size is approximately USD 443 million for the 12 months ending April 2018, as per IQVIA," Sun Pharma said.    The tablets are used to improve glycemic control in adults with type 2 diabetes.   ]]> <![CDATA[USFDA opens door to drug import]]> https://biospectrumindia.com/news/95/11361/usfda-opens-door-to-drug-import.html https://biospectrumindia.com/news/95/11361/usfda-opens-door-to-drug-import.html Wed, 25 Jul 2018 15:30:00 +0530 US Department of Health & Human Services (HHS) said that the Donald Trump administration is working on ways to import drugs from other countries. US President Trump has been vocal about the administration’s concern over the soaring novel drug prices and lower competition.   In order to overcome the shortcoming and lower the price of prescription drugs, the Trump administration is now exploring ways to safely import certain drugs from foreign countries.   As per HHS Secretary, Alex Azar, USFDA is forming a working group to examine how to safely import prescription drugs from other countries in an event of a dramatic price increase for a drug produced by one manufacturer and not protected by patents or exclusivities.   This working group will examine the potential to promote competition for drugs that are off-patent or off-exclusivity and produced by one manufacturer. This stands in contrast to proposals to import a broader range of drugs, which raise additional questions about how to protect American patients.   The working group will consider drugs unprotected by patents or exclusivities, which will allow other manufacturers to introduce new competition. Importation will be limited to cases where drugs can be imported with adequate assurances of safety and effectiveness.   Because the drugs being considered for importation are off-patent and have no exclusivity remaining, the proposals contemplated by the working group would not dilute intellectual property rights or affect incentives for innovation. Rather, they would provide a new avenue for competition to drive down prices for American patients.   This is positive for Indian pharma industry as India is having highest number of USFDA approved drug manufacturing plants outside the US.  If this opportunity comes, Indian companies are likely to benefit. ]]> <![CDATA[Dr Reddy’s launches Esomeprazole capsules]]> https://biospectrumindia.com/news/95/11347/dr-reddys-launches-esomeprazole-capsules.html https://biospectrumindia.com/news/95/11347/dr-reddys-launches-esomeprazole-capsules.html Mon, 23 Jul 2018 16:15:00 +0530 Dr Reddy’s Laboratories Ltd has launched Esomeprazole Magnesium Delayed-Release Capsules in the US market. This is an over-the-counter (OTC) therapeutic equivalent generic version of Nexium capsules. Esomeprazole Magnesium Delayed-Release Capsules is an OTC proton pump inhibitor used to treat frequent heartburn occurring two or more days in a week in adults. "This launch continues to demonstrate our R&D and manufacturing capabilities to bring newer store-brand OTC medications to the market,” said Milan Kalawadia, Vice President and Head, US OTC and Speciality Rx businesses, Dr. Reddy’s Laboratories. The combined market of Nexium capsules and private label OTC Esomeprazole Magnesium products had US sales of approximately $311 million for the most recent 12 months ended May 2018. ]]> <![CDATA[Hairline International launches therapies across five specialities]]> https://biospectrumindia.com/news/95/11345/hairline-international-launches-therapies-across-five-specialities.html https://biospectrumindia.com/news/95/11345/hairline-international-launches-therapies-across-five-specialities.html Mon, 23 Jul 2018 12:25:00 +0530 Hairline International Hair and Skin Clinic will now offer patients a range of therapies across 5 specialities of Trichology. Patients visiting any of the 7 centres of Hairline International, can now avail of specialized care focused on Geriatric, Endocrine, Pediatric, Gynaecology-related and Psychiatric-related hair loss issues. Each of these specialities will be medically managed by in-house specialized doctors, with consultants being brought on board, based on need. Speaking on the launch of these 5 specialities, Dr. Bani Anand, Founder and Managing Director, Hairline International Hair and Skin Clinic says, "The hair care needs of people varies at different stages in life and now Hairline International offers specialty treatment options in trichology catering to every segment. Eventually we will get to launching specific products which will also be used in therapies for each of these groups." Speaking on the specialities, Dr. Divya K G, Dermatologist, Hairline International Hair and Skin Clinic says, "These specialities allow us to examine each patient for specific issues that may be afflicting them based on their general health, age and gender. This allows for a more focussed approach to therapy protocols that we work out for them." Addressing the media on the importance of nutrition in Trichology care, Mansi Belani, Fitness Nutritionist, Hairline International Hair and Skin Clinic says, "While overall good nutrition may be common across age groups and genders, there is a need for customized dietary and nutritional approaches. Such approaches take into consideration age or gender specific ailments, personal health levels and more. Good nutrition is a very important factor to determine good hair and skin." Here is a look at each of the specialities- Geriatric Trichology: Besides male and female pattern baldness, alopecia areata and senescent alopecia there are several ailments that can lead to geriatric hair loss. This is particularly for patients in the age bracket of 60 years and above. These ailments can cause scarring alopecias likes LPP, Frontal Fibrosing Alopecia, Folliculitis Decalvans etc. There is also hair loss that is caused due to tumour metastasis to the scalp, commonly seen among breast cancer patients. Menopause can also cause hair loss. Overall hair loss among the elderly is multifactorial and warrants close inspection. Specialized treatments in the form of hormonal therapies, topical treatments, SMP as well as non-surgical options of hair weaving and bonding, in addition to hair transplants, will be offered to geriatric patients at Hairline International. Endocrinal Trichology: Endocrinal ailments cut across age groups. It is a fact that hair growth is regulated by hormonal changes in the body. In this specialty, patients will be diagnosed through a series of thorough blood tests. Based on individual cases, nutritional counseling will be provided. Medications that specifically deal with endocrine-related ailments will be prescribed. Additional therapies such as micro-grafting, SMP as well as hair transplants and micro-grafting options will be offered under this specialty at Hairline International. Pediatric Trichology: There are several medical reasons for hair loss in children (here considered till the age of 15 years) such as fungal infections, lice infestations, alopecia areata, Trichotillomania, tractional alopecia, Telogen Effluvium as well as endocrinal and nutritional deficiencies that can cause unusual hair loss among children. Non-medical reasons include new born hair loss, frictional hair loss as well as hair abuse. These require specialized attention, counselling as well as treatment therapies that will now be managed through the specialties at Hairline International. Gynaecology-Related Trichology: There are several gynaecological reasons why hair may be affected, especially in the age bracket of 18-55 years of age. During pregnancy, an increased number of hair go into resting phase which is a part of normal hair loss cycle. It may occur due to vitamin or mineral deficiency. Most common period of hairloss is 3 months post-delivery or post-partum. Upto 60% of hair that is in the growth phase may enter the resting phase leading to acute or chronic Telogen Effluvium. Hairloss is also triggered by the change in the estrogen levels which is characteristic of the peri- and post-menopausal stages in a woman's life. These changes in estrogen level can also affect hair in the post-menopausal stage. Each case will be examined and a personalized therapy approach will be created. Psychiatric Trichology: Many psychiatric issues such as anxiety, depression, anorexia, bulimia, schizophrenia etc., can cause issues like Alopecia areata, Tellogen effluvium and Trichotillomania etc. These issues can affect any age group. These problems can be addressed by a psychiatrist, a nutritionist and a dermatologist at Hairline by providing aesthetic help to improve confidence, self-esteem and external appearances. Each of these specialties will also involve intense focus on the diet of an individual and will be examined and prescribed by a qualified nutritionist. A psychologist will also be available at each of the 7 centers of Hairline International for counselling who will consult across all specialities. Hairline International now offers appointments across its centres for consultation under each of these specialties, based on doctor consultation and advice. What the Specialists say: There are several causes for hair loss. These causes may be related to age, sex, overall health or may be the result of complications arising for certain ailments. Dr. Sharat Honnatti, Consultant Geriatric Physician Geriatric Trichology "As a person ages, the growth rate of hair decreases. This happens because the follicles simply do not allow for hair growth as quickly. By the time a man is in his late 60s, 80% of men have some substantial balding or thinning present. Elderly women are affected, too. Hair loss in elderly individuals may also have a direct relation to a disease or other health conditions. In addition, medications used to treat some illnesses can trigger hair loss. All this and more will be investigated in Geriatric Trichology that is being offered at Hairline International." Dr. Ananthraman R, Consultant Endocrinologist Endocrinal Trichology "Endocrine problems can cause hair loss. Hair loss is a major problem among women, and it's a serious problem. The most common endocrine cause of hair loss is hypothyroidism. And patients with hypothyroid are known to have thinning of their hair, losing their hair in the shower, and especially for example their hair on the outer portion of their eyebrows is very commonly lost. The other endocrine causes of hair loss are the hormones, the sexual hormones, and also patients with too high level of testosterone can also have hair loss. These are among the basics that will be evaluated in the course of treatment under endocrinal trichology, based on symptoms presented by patients." Dr. Priyadarshini PG, Pediatric Dermatologist Pediatric Trichology: "Hair loss in children can be extremely stressful for the caretaker. Recognizing symptoms and bringing children in for examination is of utmost importance. For the majority of children 26 months or older suffering hair loss, the following could be the causes - tinea capitis, Trichotillomania, Telogen Effluvium as well as nutritional deficiencies such as the lack of Vitamin H or biotin, Vitamin A deficiency or even a Zinc deficiency. Hypothyroidism can also affect the hair in the children. There are non-medical reasons where newborns lose hair to make way for permanent hair. Hair loss from friction while rubbing on the pillow or mattress can also occur. Vigorous brushing and pulling of hair also causes hair loss." Dr. Priyanka Shukla, Obstetrician and Gynaecologist Gynaecology-Related Trichology: "There are several gynaecological reasons why hair may be affected, especially in the age bracket of 18-55 years of age. These can be related to various stages in a woman's life. These can be from hormonal changes that take place at pregnancy, post-delivery or post-partum. It can be from the stress of child birth. It can also be a result of diet and lack of exercise. Some women are also genetically inclined to hair loss. Hormonal changes in the monarchy to menopausal stage can also result in hair loss." Dr. Shilpasri SK, Consultant Psychiatrist Psychiatric Trichology: "Your mental health can be the cause of hair loss as well. Depression can affect the quality of your hair. The various physiological states of depression such as low mood, discouragement, low self-esteem and feeling drained can be a factor in reducing the hair growth phase, leading to hair loss. Anti-depressent medication too can create hair trouble. Chronic and emotional stress too can lead to hair loss. Stress related hair loss, in most cases, stops it's growth phase during a stressful period and lie dormant, causing the hair to shed. If the stress continues, the hair continues not to grow." ]]> <![CDATA[WHO identifies new antifungal class by granting "ibrexafungerp" to SCYNEXIS]]> https://biospectrumindia.com/news/95/11331/who-identifies-new-antifungal-class-by-granting-ibrexafungerp-to-scynexis.html https://biospectrumindia.com/news/95/11331/who-identifies-new-antifungal-class-by-granting-ibrexafungerp-to-scynexis.html Thu, 19 Jul 2018 15:45:00 +0530 SCYNEXIS a biotechnology company delivering innovative therapies for difficult-to-treat and often life-threatening infections, announced that the World Health Organization's (WHO) International Non-proprietary Name (INN) group has assigned the generic name "ibrexafungerp" for its lead candidate SCY-078, the first representative of a novel oral and intravenous (IV) triterpenoid antifungal family. SCYNEXIS is developing ibrexafungerp for the treatment of multiple serious fungal infections, including vulvovaginal candidiasis (VVC), invasive candidiasis (IC), invasive aspergillosis (IA) and refractory invasive fungal infections. "For nearly two decades, only three drug classes have encompassed all FDA-approved antifungal treatments. Ibrexafungerp has the potential to represent the first new antifungal class approved since 2001, providing unique benefits of critical importance given the rapidly rising rates of antifungal resistance to many standards of care therapies," said Marco Taglietti, M.D., President and Chief Executive Officer of SCYNEXIS. The INN system was established to facilitate the identification of pharmaceutical substances or active pharmaceutical ingredients in a unique, globally-recognized manner. Obtaining a non-proprietary, or generic, name is a required step in bringing a new drug to market. Generic names of pharmacologically-related substances demonstrate their relationship by using a common "stem," allowing medical practitioners and pharmacists to recognize substances having similar pharmacological activity. This is important for the clear identification, safe prescription and dispensing of medicines to patients. The generic name ibrexafungerp includes a new stem, "-fungerp," which indicates that SCY-078 is unlike any previously-approved drug, and reflects its first-in-class nature.   ]]> <![CDATA[Cipla with partnership plans to enter new therapies in Africa]]> https://biospectrumindia.com/news/95/11323/cipla-with-partnership-plans-to-enter-new-therapies-in-africa.html https://biospectrumindia.com/news/95/11323/cipla-with-partnership-plans-to-enter-new-therapies-in-africa.html Wed, 18 Jul 2018 17:50:00 +0530 Since last two years, Cipla acquired second South African over-the-counter medicine (OTC) manufacturer and distributor company Mirren, for Rs 2.28 billion. The acquisition brings cold, flu and pain relief brands to Cipla. Cipla is the fourth-largest generic drug maker in South Africa.   Africa is the second largest market for the drugmaker after India as it accounted for 22 percent of its consolidated revenue in FY 2018. Also, its Ebidta margin in South Africa is higher than its consolidated margin of 18.6 per cent (FY18).   The company's Africa portfolio includes central nervous system medication, respiratory drugs and HIV drugs in Africa. Acquisition and partnerships would give it access to other growing therapies such as cancer and hypertension.   The company is looking at inorganic growth opportunities to offset delays in product approvals and a decline in institutional tender business.   Kedar Upadhye, Cipla's global chief financial officer said that the drug major is evaluating various opportunities but refused to comment on potential deal sizes and therapies.   Cipla's main focus markets are South Africa, East Africa (Uganda, Kenya, Tanzania). Also, it has a large institutional tender business (called global access) consisting of anti-malarial and HIV drugs.   In Uganda, the company is looking to partner with the government to increase access to cancer treatment for the local population. ]]> <![CDATA[Amazon to invest in Indian Pharma brand MedPlus]]> https://biospectrumindia.com/news/95/11322/amazon-to-invest-in-indian-pharma-brand-medplus.html https://biospectrumindia.com/news/95/11322/amazon-to-invest-in-indian-pharma-brand-medplus.html Wed, 18 Jul 2018 16:00:00 +0530 Amazon is looking forward to start another business in India by buying into a pharmacy chain. The retail giant is in early talks to invest in Medplus, the second largest Indian pharmacy chain.   The online pharma industry is relatively new in India. But like with other sectors upended by Amazon in the past, offline presence is going to be at the centre of its gameplan. Medplus, founded by Madhukar Gangadi in 2006, runs over 1,400 stores across 12 Indian states.   Amazon’s move comes barely a month after it announced intentions of getting into the pharmaceuticals space by acquiring PillPack, an online pharmacy for about $1 billion. The PillPack deal wiped out $15 billion in Pharma stocks.   India’s health ministry has plans to amend the Drugs and Cosmetics Rules, 1945, to regulate online pharmacies. Companies that sell drugs online will have to register with a central organisation and won’t be allowed to sell narcotics, psychotropics and tranquillisers, as per draft rules formulated by the government.                   ]]> <![CDATA[Glenmark gets U.S. FDA nod for cholesterol lowering drug]]> https://biospectrumindia.com/news/95/11321/glenmark-gets-u-s-fda-nod-for-cholesterol-lowering-drug.html https://biospectrumindia.com/news/95/11321/glenmark-gets-u-s-fda-nod-for-cholesterol-lowering-drug.html Wed, 18 Jul 2018 11:25:00 +0530 Glenmark Pharmaceuticals has received final approval from the US health regulator for Colesevelam Hydrochloride for oral suspension, used to lower cholesterol levels in the blood. The approval has been granted by the United States Food and Drug Administration (USFDA) in the strengths of 1.875 grams/packet and 3.75 grams/packet, the company said in a BSE filing. The approved product is a generic version of Daiichi Sankyo Inc's Welchol. Quoting IQVIA sales data for the 12-month period ended May 2018, the company said Welchol achieved annual sales of around USD 73 million. The company's current portfolio consists of 138 products authorised for distribution in the US market, and 62 Abbreviated New Drug Applications (ANDAs) are pending approval with the USFDA, it added. Shares of Glenmark Pharmaceuticals were trading 1.17 per cent higher at Rs 558.05 on the BSE. ]]> <![CDATA[Aurobindo acquires Apotex for 74M euro]]> https://biospectrumindia.com/news/95/11301/aurobindo-acquires-apotex-for-74m-euro.html https://biospectrumindia.com/news/95/11301/aurobindo-acquires-apotex-for-74m-euro.html Mon, 16 Jul 2018 10:40:00 +0530 Aurobindo Pharma has signed a definitive agreement to acquire Apotex's businesses in Czech Republic, Poland, Spain, Belgium and the Netherlands for 74 million euro. The move is seen as Aurobindo's attempt to strengthen its commercial infrastructure, particularly in the generics market of Eastern Europe. At present, Aurobindo Pharma has presence in nine European countries. The acquisition was made by Aurobindo’s wholly-owned subsidiary Agile Pharma B.V. (Netherlands). Aurobindo will acquire commercial infrastructure including experienced personnel, products, marketing authorizations and dossier license rights in Poland, the Czech Republic, the Netherlands (including the manufacturing facility in Leiden), Spain and Belgium. In Poland and the Czech Republic, Aurobindo will become one of top 15 generics (Gx) companies in each country. In Poland, Aurobindo will add significant sales based on the established brand name “APO” and a dedicated sales force covering physicians and the pharmacy network. Aurobindo will also add an OTC offering in the Netherlands and will become a leading OTC company by volume. In Belgium, the acquisition will provide Aurobindo with an entry into the retail generics space, where it will become one of the top 5 players. ]]> <![CDATA[Aurigene declares first Human Dosing with AUR-101]]> https://biospectrumindia.com/news/95/11292/aurigene-declares-first-human-dosing-with-aur-101.html https://biospectrumindia.com/news/95/11292/aurigene-declares-first-human-dosing-with-aur-101.html Thu, 12 Jul 2018 12:10:00 +0530 Aurigene, a biotechnology company focused on discovering and developing drugs for oncology and inflammatory disorders, announced that it has commenced dosing in INDUS, a Phase 1 trial of AUR-101 in healthy volunteers. The study is designed to evaluate the safety signals, pharmacodynamic modulation, and recommended dosage for Phase 2 studies (RP2D). AUR-101 is a selective, potent inverse agonist of the receptor RoRγt, designed as an oral agent for the treatment of IL17-driven immunological conditions, including psoriasis. Aurigene expects data from the INDUS study to be available by December 2018. Aurigene currently has three programs from its pipeline in clinical development. Aurigene's oral PD-L1/ VISTA antagonist CA-170 is currently in Phase 2 clinical development in India. Commenting on the trial, CSN Murthy, CEO of Aurigene said: "This is the first study of the planned global clinical development for AUR-101; we are excited to have started the clinical evaluation of the compound and expect to mirror the excellent results seen in established pre-clinical disease models". ]]> <![CDATA[Boehringer Ingelheim, Lupin to market two anti-diabetic drugs]]> https://biospectrumindia.com/news/95/11291/boehringer-ingelheim-lupin-to-market-two-anti-diabetic-drugs.html https://biospectrumindia.com/news/95/11291/boehringer-ingelheim-lupin-to-market-two-anti-diabetic-drugs.html Thu, 12 Jul 2018 11:10:00 +0530 Boehringer Ingelheim and Lupin Limited (Lupin) announced the expansion of their partnership with plans to market two new oral anti-diabetics Gibtulio Met® (Empagliflozin + Metformin) and Ajaduo® (Empagliflozin + Linagliptin) which are recently approved by the Drugs Controller General of India (DCGI)   Both these products belong to a novel class of oral anti-diabetic drugs patented in India and will be launched for the first time by an Indian company. The two products will be co-marketed simultaneously by Boehringer Ingelheim and Lupin across India under different brand names. The Empagliflozin + Linagliptin combination is the world’s first approved combination of an SGLT-2 inhibitor and DPP4 inhibitor. In addition to a strong effect on lowering blood sugar levels, it also addresses multiple pathophysiological defects in type 2 diabetes and is a big step towards improved management of type 2 diabetes. It will also help in reducing the pill burden for patients and help improve adherence to the prescribed treatment. The Empagliflozin + Metformin combination can be given to newly diagnosed patients at higher baseline HbA1c levels and would help manage cardiac complications in patients with type 2 diabetes with heart disease. Lupin’s India business grew to INR 44,129 Mn, and is the 5th largest pharmaceutical company by sales in the Indian Pharmaceutical Market, with a focus on its top three therapies areas of Cardiac, Anti-Diabetes and Respiratory. Lupin is the fastest growing company amongst leading majors in the Anti-Diabetes market and on a monthly basis is ranked as the 3rd largest company in the Indian Diabetes market as per IQVIA. The sales of Lupin’s Diabetes portfolio grew to INR 8,430 Mn at a growth rate of 24% YOY which is more than twice that of the market growth rate.   ]]> <![CDATA[Aurobindo Pharma to bring Azithromycin tablets to market]]> https://biospectrumindia.com/news/95/11285/aurobindo-pharma-to-bring-azithromycin-tablets-to-market.html https://biospectrumindia.com/news/95/11285/aurobindo-pharma-to-bring-azithromycin-tablets-to-market.html Wed, 11 Jul 2018 15:00:00 +0530 Aurobindo Pharma has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Azithromycin tablets. These tablets will be used for the treatment of patients with mild to moderate infections, in the US market. Hyderabad-based company said that the product will be launched in July 2018. The approval has been granted in the strengths of 250 mg and 500 mg, and the product will be launched this month. The approved product is a generic equivalent of Pfizer Inc's Zithromax tablet. Quoting IQVIA sales data, the company said, the approved product has an estimated market size of USD 132 million for the 12 months ending May 2018. This is the 146th ANDA (including 19 tentative approvals) to be approved out of the Unit VII formulation facility in Hyderabad, used for manufacturing oral products. ]]> <![CDATA[Dr. Reddy’s announces launch of Plaquenil generic]]> https://biospectrumindia.com/news/95/11283/dr-reddys-announces-launch-of-plaquenil-generic.html https://biospectrumindia.com/news/95/11283/dr-reddys-announces-launch-of-plaquenil-generic.html Wed, 11 Jul 2018 14:25:00 +0530 Dr. Reddy’s Laboratories Ltd. has announced the launch of Hydroxychloroquine Sulfate Tablets USP, 200 mg, a therapeutic equivalent generic version of Plaquenil (hydroxychloroquine sulfate) Tablets, in the U.S. market, approved by the U.S. Food and Drug Administration (USFDA). The Plaquenil brand and generic had U.S. sales of approximately $215 million MAT for the most recent twelve months ending in May 2018 according to IMS Health. Dr. Reddy’s Hydroxychloroquine Sulfate Tablets are available in 200 mg tablets in the bottle count sizes of 100 and 500. Plaquenil is a trademark of Concordia International Corp. ]]> <![CDATA[Pfizer rolls back increase in drug price]]> https://biospectrumindia.com/news/95/11280/pfizer-rolls-back-increase-in-drug-price.html https://biospectrumindia.com/news/95/11280/pfizer-rolls-back-increase-in-drug-price.html Wed, 11 Jul 2018 10:50:00 +0530 Pharmaceutical giant Pfizer has announced it will roll back the price increase of some 40 drugs after US President Donald Trump issued public warnings to the company. Pfizer said in a statement on Tuesday that it would postpone the price hike to at least the beginning of 2019. "Pfizer is rolling back price hikes, so American patients do not pay more. We applaud Pfizer for this decision and hope other companies do the same. Great news for the American people!" Trump said on his Twitter account later. Pfizer's decision comes a day after Trump threatened the company with unspecified measures following its price increase announcement a few days earlier. "Pfizer and others should be ashamed that they have raised drug prices for no reason," Trump tweeted. "They are merely taking advantage of the poor and others unable to defend themselves, while at the same time giving bargain basement prices to other countries in Europe and elsewhere. We will respond!" he added. Among the products affected by the price increase include Viagra, an erectile dysfunction medication; Xalkori, a lung cancer medicine and Lyrica, a medication used in treating neuropathic or nerve pain. This is the second time the New York-based pharmaceutical company has raised prices of its products in 2018, while other companies, such as the French Sanofi group, have also increased their prices, according to the Wall Street Journal.Trump, who is currently in Brussels for a North Atlantic Treaty Organization (NATO) summit, also said he had spoken with Pfizer CEO Ian Read and Secretary of Health and Human Services Alex Azar about his drug pricing proposal. In May, Trump announced a plan to reduce drug costs, a strategy that aims to force other countries to raise their drug prices and reduce them in the US. However, his plan did not impose any concrete price ceiling for drug manufacturers, which can charge customers in the US according to market demand as the American government does not regulate their prices like other countries. According to data from the Organization for Economic Cooperation and Development, each US citizen spent an average of $1,162 on pharmaceutical products in 2015, compared to $756 in Canada and $497 in the UK, where the governments impose measures to regulate the prices. ]]> <![CDATA[DNP+ challenges patents on Gilead’s hepatitis C drugs ]]> https://biospectrumindia.com/news/95/11273/dnp-challenges-patents-on-gileads-hepatitis-c-drugs-.html https://biospectrumindia.com/news/95/11273/dnp-challenges-patents-on-gileads-hepatitis-c-drugs-.html Tue, 10 Jul 2018 12:55:00 +0530 Delhi Network of Positive People (DNP+) has filed two patent oppositions before the Indian patent office, challenging additional patent claims by US pharmaceutical corporation-Gilead Sciences for the hepatitis C medicines sofosbuvir and velpatasvir. These oppositions challenge Gilead’s patent applications for the tablet formulation of the fixed-dose combination of sofosbuvir/velpatasvir and the polymorph form of velpatasvir. Velpatasvir, a direct acting antiviral (DAA), is one of the key medicines used in combination with sofosbuvir for the oral treatment of people with all six major genotypes of hepatitis C virus. Its effectiveness as a pan-genotypic medicine makes it a key drug in the fight against hepatitis C. Access to affordable generic sources of this medicine, and its combination with sofosbuvir, are therefore critical for all countries with a high burden of people living with hepatitis C. Sofosbuvir/velpatasvir was launched in the United States by Gilead at over $74,000 for a 12-week regimen in 2016. The grounds for these two patent oppositions are based on provisions in the Indian Patents Act that prevent patent evergreening, which restricts the patentability of a host of secondary patents, i.e., new forms of known substances, new property or new use of known substances, use of known processes without showing any enhanced therapeutic efficacy, and admixtures without synergistic effect. India plays a critical role in supplying developing countries with affordable, quality lifesaving generic medicines, largely because the country’s patent law strikes a balance between promoting public health and access to medicines, while also protecting companies’ intellectual property rights by granting patents for true innovative developments. However, a recent study on the Indian patent office has highlighted that a larger number  over 70% of the patents analysed from 2009-2016 – are for marginal improvements, many of which were granted erroneously even though India’s Patents Act explicitly aims to protect against corporations being able to ‘evergreen’ their patent claims. This lack of rigorous assessment of the patentability requirements in pharmaceuticals is a worrying development in India. Through these patent oppositions, DNP+ aims to prevent such unmerited patent applications from being granted and encourage open competition on the combination of sofosbuvir and velpatasvir after the basic compound patents have expired or are revoked in countries excluded from Gilead’s license agreements.   ]]> <![CDATA[China ready to slash Indian medicine tariffs ]]> https://biospectrumindia.com/news/95/11272/china-ready-to-slash-indian-medicine-tariffs-.html https://biospectrumindia.com/news/95/11272/china-ready-to-slash-indian-medicine-tariffs-.html Tue, 10 Jul 2018 11:35:00 +0530 China and India have entered in an agreement to reduce tariffs and increase imports of Indian medicines, particularly anti-cancer drugs, part of moves to broaden its trade relations amid its on-going spat with the United States. Both India and China slashed import tariffs of a range of products starting July 1, following the fourth round of negotiations under the Asia Pacific Trade Agreement (APTA), which also includes Bangladesh, Laos, South Korea and Sri Lanka. China said it would reduce tariffs on 8549 items including chemical and agricultural products, while India would do likewise for 3142 products. India has particularly pressed China to open up its market for pharmaceuticals, which was highlighted by Prime Minister Narendra Modi during the April 28 Wuhan Summit with President Xi. The Chinese Foreign Ministry said on Monday that China and India had reached an agreement on reducing tariffs on Indian medicines, especially anti-cancer drugs. There is widespread demand in China for Indian anticancer drugs which are often one-tenth the cost of the Western drugs that are available in China. Indian drugs, especially cancer curing medicines, are in big demand in China as they are far cheaper. About 4.3 million people are diagnosed with cancer annually in China. In May, China had lifted tariffs on the import of cancer drugs. India has been demanding the opening of China's IT and medicine sectors as part of measures to reduce over USD 51 billion trade deficit in over USD 84 billion bilateral trade. Both the sides have stepped up negotiation to import Indian rice, sugar and pharmaceuticals after a meeting between Prime Minister Narendra Modi and Chinese President Xi Jinping during the April 28 Wuhan informal summit. ]]> <![CDATA[Dr Reddy's, UCB to promote Briviact for epilepsy treatment]]> https://biospectrumindia.com/news/95/11268/dr-reddys-ucb-to-promote-briviact-for-epilepsy-treatment.html https://biospectrumindia.com/news/95/11268/dr-reddys-ucb-to-promote-briviact-for-epilepsy-treatment.html Mon, 09 Jul 2018 16:15:00 +0530 Dr. Reddy's Laboratories Limited and UCB, a biopharmaceutical company, have announced that they have entered into a distribution and co-promotion agreement for Briviact®, a brand of brivaracetam. The agreement grants Dr. Reddy’s the exclusive right to distribute Briviact® in India. Briviact® (brivaracetam) is approved as an adjunctive therapy for the treatment of partial-onset seizures in epilepsy patients who are 16 years of age and older.   V. Ramana, CEO - Branded Markets (India and Emerging Markets), Dr. Reddy’s said, “In our endeavor to make innovative medicines accessible to patients in India, we are excited to partner withUCB India for Briviact®, a novel treatment for epilepsy that will make a difference to the lives of patients living with epilepsy.”  “We know that as many as one third of people with epilepsy are currently uncontrolled on their existing medicines.” Explained Max Bricchi, Head of International Markets, UCB Neurology Patient Value Unit. “This partnership is another important step towards us providing value together to patients by making Briviact® available as an additional treatment choice for epilepsy.” Epilepsy is the second most common neurological condition and as per a recent study*, an estimate of 70 million people suffer from it worldwide. There are over 12 million people suffering from epilepsy in India, which contributes to nearly one-sixth of the global burden. ]]> <![CDATA[Merck introduces Ready-to-use PyroMAT In Vitro System ]]> https://biospectrumindia.com/views/95/11266/merck-introduces-ready-to-use-pyromat-in-vitro-system-.html https://biospectrumindia.com/views/95/11266/merck-introduces-ready-to-use-pyromat-in-vitro-system-.html Mon, 09 Jul 2018 15:10:00 +0530 Pyrogen Detection: Want to stop using animal based methods and get higher sensitivity? We are glad to inform you that our new in vitro solution for pyrogen detection is now available: our PyroMAT™ system is the only cell-line based Monocyte Activation Test (MAT) provided as a ready-to-use kit on the market. The PyroMAT™ system is based on the use of the Mono-Mac-6 cell line: it is designed to provide a standardized reactivity. Once these human monocytes come into contact with pyrogens from a contaminated sample, they produce cytokines such as interleukin-6 (IL-6), which can be detected with enzyme-linked immunosorbent assay (ELISA). With the PyroMAT™ System, we offer a new robust and sensitive solution for pyrogen detection supported by international regulations and guidelines to reduce animal consumption for pyrogen tests. Make the move to in vitro methods, and benefit from our expertise: The advantages of monocyte activation test… Detection of the full range of pyrogens to ensure patient safety. Like the rabbit pyrogen test, MAT is effective in the detection of both endotoxins and Non-Endotoxin Pyrogens (NEP). Extended range of testable products: the most frequently applied methods are limited in the product types they are able to test. The MAT offers more flexibility regarding its applications. In vitro assay that mimics the human immune reaction: for a robust predictive model that reduces animal consumption. Compliance with international regulations and guidelines in line with ethical trends of industry and regulatory authorities to decrease the use of animal based testing. ... Combined with the benefits of using a cell line Standardized reactivity and high sensitivity (LOD 0.05 EU/mL) Convenience of a ready-to-use cell line to avoid laborious lab work to maintain the cell line and avoids the need of a culture cell laboratory. Qualified cells: in addition to being cited in the international validation of MAT, MonoMac-6 cells are qualified for the detection of all types of pyrogens via testing of the expression of all surface Toll-Like Receptors (TLRs). ]]> <![CDATA[Dr Batra's Healthcare receives Iconic Brand title]]> https://biospectrumindia.com/news/95/11264/dr-batras-healthcare-receives-iconic-brand-title.html https://biospectrumindia.com/news/95/11264/dr-batras-healthcare-receives-iconic-brand-title.html Mon, 09 Jul 2018 13:35:00 +0530 Dr Batra's Healthcare is recognised as an 'Icon of Indigenous Excellence in Healthcare' at the recently held The Economic Times Iconic Brands of India 2018 awards. The global leader in homeopathy is recognised for its unprecedented success and contribution in the field of homeopathy. Having carved a distinct niche for itself in the last four decades globally in the field of Homeopathy, Dr Batra' Healthcare is known for its stringent medical protocols that provide patients with the best treatment and experience in medical care. With an extensive pool of medical knowledge and experience of over 400 doctors having treated over 15 lakh patients, Dr Batra's Healthcare provides safe and effective treatment without side effects for the varied disorders including Allergies, Child Health, Hair loss Preventive Health (Male/Female/Child), Skin Disorders, Stress Management, Weight Management, Women's Health and Sexual Health. Commenting on the receiving this prestigious title, Dr. Mukesh Batra, Founder & Chairman Emeritus, Dr Batra's Healthcare, said, "We are extremely privileged to be recognised as an 'Iconic Brand of India'. Every award we receive is not just an appreciation of the achievement but also a responsibility for us to strive to reach greater successes through innovation and excellence in homeopathic healthcare. This award is all the more special as we launch one of our most innovative treatments, Dr Batra's Geno Homeopathy that will help us revolutionize the future of healing. At Dr Batra's, we have always believed that technology and research should be at the core of evolving therapies and through our continuous efforts, we hope to always provide uncompromising levels of expertise and unmatched medical experience to our patients in India and across the globe." ]]> <![CDATA[Lupin mandates Trend Micro to ensure security]]> https://biospectrumindia.com/news/95/11258/lupin-mandates-trend-micro-to-ensure-security.html https://biospectrumindia.com/news/95/11258/lupin-mandates-trend-micro-to-ensure-security.html Fri, 06 Jul 2018 11:50:00 +0530 Trend Micro Incorporated, a global leader in cybersecurity solutions secures Lupin Limited, a transnational  leader in the pharmaceutical industry, by addressing their security needs across data centres, endpoints, email and networks. Trend Micro was also able to complement the existing security solutions of Lupin Limited through a comprehensive security across their major vectors, advanced shielding from vulnerabilities with virtual patching and safeguarding of networks and endpoints against advanced attacks. By providing out-of-box integration with existing perimeter security solutions, Trend Micro was able to further simplify Lupin’s security operations with a single management dashboard for all capabilities. Lupin Limited required a high-level security solution to safeguard critical applications in its data centres, while also requiring protection of email on Microsoft Office 365 against advanced attacks a priority. With more than 300 servers running on multiple operating systems, Lupin also required the ability to detect targeted attacks, advanced threats, and ransomware across the network, capturing lateral, inbound and outbound traffic. Finally, Lupin wanted to manage the solution through a single console. “Trend Micro is a huge plus to our organization. It has increased security by reducing the risk of data breaches. The virtualized environment has streamlined administration, without compromising security or flexibility,” said Mr. Mayur Danait, CIO, Lupin Limited. ]]> <![CDATA[Ideal Cures launches new film coatings for pharma applications ]]> https://biospectrumindia.com/news/95/11249/ideal-cures-launches-new-film-coatings-for-pharma-applications-.html https://biospectrumindia.com/news/95/11249/ideal-cures-launches-new-film-coatings-for-pharma-applications-.html Thu, 05 Jul 2018 11:30:00 +0530 Ideal Cures, an Indian company headquartered in Mumbai, India, launched two new ready-to-use film coating products INSTACOAT QD and INSTACOAT T2F, at the 2nd Formulation and Drug Delivery Conclave (FDD), held on 15th-16th June 2018, at Hyderabad, India where more than 110 formulators of top India based pharma companies were present. INSTACOAT QD, quick disintegrating film coating product is revolutionary for pharmaceutical applications which provides fast disintegration of film within 3-30 seconds. INSTACOAT T2F is a brilliant ready-to-use coating product by Ideal Cures that is completely free from Talc and TiO2. This product was developed because there have been many speculations, questions and concerns about talc and titanium dioxide as being carcinogenic. Hence, their use is discouraged in Europe and US. Mr. Suresh Pareek, Managing Director of Ideal Cures Pvt. Ltd., who is also one of the inventors, said, "Ideal Cures is driven by its vision to provide the best solutions to the industry by continuously developing new and innovative products. We aimed to add another milestone to our mission of assisting the pharma industry with its need for better drug delivery systems and regulatory compliances with these two products." ]]> <![CDATA[Biocon receives EU approval for Biosimilar facility]]> https://biospectrumindia.com/news/95/11247/biocon-receives-eu-approval-for-biosimilar-facility.html https://biospectrumindia.com/news/95/11247/biocon-receives-eu-approval-for-biosimilar-facility.html Thu, 05 Jul 2018 10:00:00 +0530 Biocon Ltd, Asia’s premier biopharmaceutical company, has announced that it has received the EU GMP certification for its Sterile Drug Product manufacturing facility in Bengaluru, which was inspected by the European agencies in March 2018. This facility is used for the manufacturing of Biocon’s portfolio of biosimilars.  Biocon remains committed to global standards of quality and compliance. ]]> <![CDATA[Suven Life Sciences secures product patents]]> https://biospectrumindia.com/news/95/11242/suven-life-sciences-secures-product-patents.html https://biospectrumindia.com/news/95/11242/suven-life-sciences-secures-product-patents.html Wed, 04 Jul 2018 14:00:00 +0530 Suven Life Sciences secures four product patents from India, Singapore, South Korea and Israel. Suven Life Sciences has secured four product patents from India, Singapore, South Korea and Israel corresponding to the New Chemical Entities (NCEs) for the treatment of disorders associated with Neurodegenerative diseases and these Patents are valid through 2031, 2034, 2034 and 2036 respectively. The granted claims of the patents include the class of selective 5-HT4 compounds and are being developed as therapeutic agents for neurodegenerative disorders such as for the treatment of cognitive impairment associated with neurodegenerative disorders like Alzheimer’s disease, Attention deficient hyperactivity disorder (ADHD), Huntington’s disease, Parkinson and Schizophrenia etc. “We are very pleased by the grant of these patents to Suven for our pipeline of molecules in CNS arena that are being developed for cognitive disorders with high unmet medical need with huge market potential globally” says Venkat Jasti, CEO of Suven. ]]> <![CDATA[Natco Pharma launches Hepatitis C drug in India]]> https://biospectrumindia.com/news/95/11236/natco-pharma-launches-hepatitis-c-drug-in-india.html https://biospectrumindia.com/news/95/11236/natco-pharma-launches-hepatitis-c-drug-in-india.html Tue, 03 Jul 2018 12:40:00 +0530 Natco Pharma has launched a fixed dose combination of Sofosbuvir-Daclatasvir tablets for the treatment of Hepatitis C under the brand name Hepcinat Plus in India. The product is a generic fixed dose combination of Sofosbuvir 400 mg and Daclatasvir 60mg tablets used for the treatment of patients with chronic Hepatitis C virus infection, the company said in a filing to the BSE. Natco Pharma has launched the drug at a maximum retail price of Rs 17,500 for a bottle of 28 tablets. Shares of Natco Pharma were trading down by 2.01 per cent at Rs 787.35 on the BSE. ]]> <![CDATA[Boiron brings pre-medicated homeopathic globules in Indian market]]> https://biospectrumindia.com/news/95/11232/boiron-brings-pre-medicated-homeopathic-globules-in-indian-market.html https://biospectrumindia.com/news/95/11232/boiron-brings-pre-medicated-homeopathic-globules-in-indian-market.html Tue, 03 Jul 2018 11:25:00 +0530 Boiron India, subsidiary of Boiron France, worldwide leader in homeopathy has launched pre-medicated standardised homeopathic medicines for the first time in India.   The initiative will boost homeopathy standards and ensure patients have access to high quality and reliable homeopathic products.   Available globally, the pre-medicated globules in innovative packaging provide superior quality, convenience and experience compared to traditional homeopathy products.   The globules are manufactured in-house with a two-week long process and a proprietary technology to ensure uniform size, layered formation and optimal porosity for retention of the dilution.   A proprietary triple medication system ensures uniform absorption of the dilution to the core of the globules.   This innovative global product called ‘Boiron Tubes’ provides the homeopathic remedies in an innovative delivery system. Boiron Tubes provide patients with ease-of-use & guaranteed delivery of the right dose.     Boiron’s R&D effort is focused on developing effective & standardized products by conducting clinical trials.   Boiron uses patented processes and technologies that combine traditional methods with modern science so that the products comply not only with homeopathic principles but also exhibit high quality standards. Prashant Surana, MD, Boiron India said, “We are introducing medicated globules in the form of Multidose Tubes and Single Dosages which are made in France and offer the highest level of standardisation and convenience to the patients. Indian patients and practitioners will tend to benefit from such high-quality offerings that include evidence-based products with reproducible results. The same product is available in US and Europe at much higher price.”     Boiron products are used by over 30 crore patients and prescribed by over 4 lakh health professionals across the world.     Mr Surana said, “With economic growth and rising life-style and education levels, Indian consumers are becoming more demanding and more appreciative of world class quality. Our research with consumers shows that they appreciate the quality and innovation in our products.” ]]> <![CDATA[Natco Pharma releases Hepatitis C drug in India]]> https://biospectrumindia.com/news/95/11229/natco-pharma-releases-hepatitis-c-drug-in-india.html https://biospectrumindia.com/news/95/11229/natco-pharma-releases-hepatitis-c-drug-in-india.html Tue, 03 Jul 2018 10:50:00 +0530 Fixed dose combination of Sofosbuvir-Daclatasvir tablets for the treatment of Hepatitis C under the brand name Hepcinat Plus, has been launched by Natco Pharma in India.  The product is a generic fixed dose combination of Sofosbuvir 400 mg and Daclatasvir 60mg tablets, used for the treatment of patients with chronic Hepatitis C virus (HCV) infection  The company has launched the drug at a maximum retail price of Rs 17,500 for a bottle of 28 tablets.      ]]> <![CDATA[Ferring Pharma invests $250M in new Hyderabad facility]]> https://biospectrumindia.com/news/95/11220/ferring-pharma-invests-250m-in-new-hyderabad-facility.html https://biospectrumindia.com/news/95/11220/ferring-pharma-invests-250m-in-new-hyderabad-facility.html Mon, 02 Jul 2018 11:30:00 +0530 Switzerland-based Ferring Pharmaceuticals has recently laid the foundation for its R&D laboratory and manufacturing facility at Genome Valley, Hyderabad. The new facility will also add to the group’s global R&D capabilities and will cater to building a pool of novel research for emerging healthcare challenges around the world. Ferring plans to complete the project in three phases with a total proposed investment of $250 million, with an estimated Rs 235 crores into the first phase itself. Minister for Industries, IT, MA & UD, Government of Telangana, K Taraka Rama Rao and several dignitaries including senior TSIIC officials took part in the ceremony. Ferring Pharmaceuticals deals with reproductive medicine and women’s health with strong presence in areas within gastroenterology and urology. The group has headquarters in St Prex, Switzerland with a portfolio of manufacturing facilities across Europe, North America, South America, China and India marketing its products in over 110 countries. ]]> <![CDATA[Lupin collaborates with European Association of Urology]]> https://biospectrumindia.com/news/95/11219/lupin-collaborates-with-european-association-of-urology.html https://biospectrumindia.com/news/95/11219/lupin-collaborates-with-european-association-of-urology.html Mon, 02 Jul 2018 11:25:00 +0530 Mumbai based pharma major Lupin and the European Association of Urology (EAU) have recently announced a collaboration to further the cause of Urology in India. With this collaboration, Lupin brings European Association of Urology's biggest event and experts to India for the very first time. The first activity as part of this collaboration will be a medical symposium for the Indian urology community scheduled to be held in July across five cities. By bringing the best of Annual EAU Congress, this program will provide Indian Urology practitioners an opportunity to get accustomed with the latest advancements made at a global level and to apply these global best practices for patients in India. This is the first time such a program will be conducted in India, and will see a select group of world-renowned urologists in attendance to discuss clinical practices and key research developments in the field. ]]> <![CDATA[Boiron launches pre-medicated homeopathic medicines in India]]> https://biospectrumindia.com/news/95/11214/boiron-launches-pre-medicated-homeopathic-medicines-in-india.html https://biospectrumindia.com/news/95/11214/boiron-launches-pre-medicated-homeopathic-medicines-in-india.html Fri, 29 Jun 2018 15:25:00 +0530 Boiron India, subsidiary of Boiron France, worldwide leader in homeopathy has launched pre-medicated standardised homeopathic medicines for the first time in India. The initiative will boost homeopathy standards and ensure patients have access to high quality and reliable homeopathic products. Available globally, the pre-medicated globules in innovative packaging provides superior quality, convenience and experience compared to traditional homeopathy products. The globules are manufactured in-house with a two-week long process and a proprietary technology to ensure uniform size, layered formation and optimal porosity for retention of the dilution. A proprietary triple medication system ensures uniform absorption of the dilution to the core of the globules. This innovative global product called ‘Boiron Tubes’ provides the homeopathic remedies in an innovative delivery system. Boiron Tubes provide patients with ease-of-use & guaranteed delivery of the right dose. Prashant Surana, MD, Boiron India said, “We are introducing medicated globules in the form of Multidose Tubes and Single Dosages which are made in France and offer the highest level of standardisation and convenience to the patients. Indian patients and practitioners will tend to benefit from such high-quality offerings that includes evidence-based products with reproducible results. The same product is available in US and Europe at much higher price.” Boiron's R&D effort is focused on developing effective & standardized products by conducting clinical trials. Boiron uses patented processes and technologies that combine traditional methods with modern science so that the products comply not only with homeopathic principles but also exhibit high quality standards. Mr Surana said, “Ever since our inception, our mission has been to improve technical manufacturing conditions to ensure large scale production of reproducible and reliable homeopathic medicines. Since we control the entire production process – from the source of raw material to what the patient consumes, we can ensure that the patient receives an uncontaminated product of consistent purity and quality.” Boiron, headquartered in France, is the worldwide leader in the field of homeopathy, with presence in more than 50 countries. Boiron products are used by over 30 crore patients and prescribed by over 4 lakh health professionals across the world. Since its inception in 1932, the company has been a pioneer in advancing the frontiers of homeopathy in various areas, such as education, practice, research, innovative technologies, quality, standardisation and ease of use. Boiron’s manufacturing plant is approved by US FDA and EMEA that ensures products are made under Current Good Manufacturing Practice (CGMPs) for the highest standards. Mr Surana said, “With economic growth and rising life-style and education levels, Indian consumers are becoming more demanding and more appreciative of world class quality. Our research with consumers shows that they appreciate the quality and innovation in our products.” ]]> <![CDATA[Lupin, MCGM unite to launch Anti-TB Campaign in Mumbai]]> https://biospectrumindia.com/news/95/11212/lupin-mcgm-unite-to-launch-anti-tb-campaign-in-mumbai.html https://biospectrumindia.com/news/95/11212/lupin-mcgm-unite-to-launch-anti-tb-campaign-in-mumbai.html Fri, 29 Jun 2018 15:20:00 +0530 Pharma major Lupin, a pioneer in the fight against Tuberculosis (TB), along with the Municipal Corporation of Greater Mumbai (MCGM) has announced a joint campaign to detect and address active cases of TB in Mumbai. The door-to-door Active Case Finding (ACF) campaign will cover all high-risk population areas selected from all 24 wards under the MCGM. A contagious and airborne disease, TB ranks as the 2nd leading cause of death from a single infectious agent, after the Human Immunodeficiency Virus (HIV).The incidence of TB has been steadily increasing in the country, with India having the highest burden of TB in the world; an estimated 28 lakh cases annually, which accounts for one fourth of the global incidence of the disease. This results in almost 500,000 Indians losing their lives to TB each year. This is further compounded by a lack of awareness, which in turn leads to delay in the commencement of treatment. One of the main hurdles for TB eradication is the inability to detect all active cases from the community. There is a growing need to identify undetected cases from the community to prevent covert transmission. This campaign and the methodology of execution follows the success of the Active Case Finding (ACF) pilot that was conducted by Lupin along with the TB department of the MCGM in 2017. The new 12-month project will involve comprehensive end-to-end TB detection, treatment and follow-up with door-to-door visits conducted in high-risk areas to identify symptomatic patients. Speaking at the launch of this campaign, Mr. Nilesh Gupta, Managing Director, Lupin said, “With a high rate of prevalence and resultant mortality, TB has reached epidemic proportions impacting especially underprivileged sections of the community. As a global leader in anti-TB medicines, we have concentrated our energies in combatting TB for nearly five decades. As part of Dr. Desh Bandhu Gupta’s vision to address areas of high national priority, we would like to extend our responsibility beyond research, manufacture, supply and marketing of TB drugs to create community outreach programs of the type we are launching today. Our partnership with MCGM is aligned with the national mission of making India TB-free by 2025 and this step will help move in the right direction towards a TB-free Mumbai.” The project will enlist the services of over 3,000 Community Health Volunteers (CHVs) of the TB department of MCGM, who will be imparted special training for this project. The efforts of the CHVs will be further supported by volunteers for facilitating the effective diagnosis of suspected patients and delivering their test results, arranging for treatment with the Revised National Tuberculosis Control Programme (RNTCP), and following the outcome of each individual case to closure. Commenting on the partnership Dr. Padmaja Keskar, Executive Health Officer, MCGM said, “Great things can be achieved if the public and private sector in India collaborate to resolve major issues faced by the nation. Through this partnership with Lupin, it would be possible to reach out to unidentified patients of TB in the community and treat them effectively. This initiative will adopt a door-to-door approach for a 12-month period and intends to cover all high-risk population in Mumbai.” Lupin is the world’s largest manufacturer of anti-TB drugs and has been active in this space for 50 years. In 2016, Lupin developed a new approach for finding active cases of TB that was piloted in Mumbai between 2016 and 2017, and covered a population of over 21 lakh. The pilot conducted in 5 wards of the MCGM, involved deployment of an ecosystem of partner NGOs and community workers who made door-to-door visits, facilitated testing to verify positive cases and ensured follow-ups for treatment.   ]]> <![CDATA[Lupin, Mylan to commercialize Enbrel Biosimilar]]> https://biospectrumindia.com/news/95/11197/lupin-mylan-to-commercialize-enbrel-biosimilar.html https://biospectrumindia.com/news/95/11197/lupin-mylan-to-commercialize-enbrel-biosimilar.html Thu, 28 Jun 2018 11:00:00 +0530 Pharma major Lupin Limited and global pharmaceutical company Mylan have announced that the two companies will partner to commercialize a biosimilar to Enbrel (etanercept). Through the partnership agreement, Mylan will commercialize Lupin's proposed etanercept biosimilar in Europe, Australia, New Zealand, Latin America, Africa and most markets throughout Asia. Enbrel is a TNF-inhibitor indicated to treat certain autoimmune diseases, including rheumatoid arthritis, psoriatic arthritis, plaque psoriasis and ankylosing spondylitis. Enbrel had global brand sales of approximately $11.6 billion for the 12 months ending Dec. 31, 2017, according to IQVIA. Lupin successfully completed its Etanercept biosimilar Phase 3 clinical trial in February 2018. Lupin has filed the product with the European Medicines Agency and plans to file the product in other jurisdictions. Under the terms of the agreement, Lupin will receive an up-front payment of $15 million and potential commercial milestones together with an equal share in net profits of the product. ]]> <![CDATA[AstraZeneca, Merck hope for expansion of Lynparza use]]> https://biospectrumindia.com/news/95/11195/astrazeneca-merck-hope-for-expansion-of-lynparza-use.html https://biospectrumindia.com/news/95/11195/astrazeneca-merck-hope-for-expansion-of-lynparza-use.html Wed, 27 Jun 2018 17:30:00 +0530 AstraZeneca's oncology business received a boost recently as results of a clinical trial showed its drug Lynparza helped women with ovarian cancer live longer without their disease worsening when given as a first-line treatment. Lynparza was the first poly (ADP-ribose) polymerase (PARP) class drug approved and is one of AstraZeneca’s fastest growing sales prospects. The result should pave the way for expanded use of the medicine, which is being developed and marketed with Merck & Co under a deal struck last year.   Lynparza is already approved for later use in patients with so-called BRCA genetic mutations. Its success in first-line therapy could expand the number of women with newly diagnosed ovarian cancer who are suitable for the drug by 30-50 percent, AstraZeneca believes.   Based on the strong results seen in the latest Phase III study, known as SOLO-1, AstraZeneca and Merck said they would talk to regulators about approving the earlier use of the medicine in women with BRCA mutations, which can drive tumour growth.   "It is the first time that we see a significant and clinically impactful improvement in progression-free survival in the first-line maintenance setting for women with BRCA-mutated ovarian cancer treated with a PARP inhibitor," said Sean Bohen, chief medical officer at AstraZeneca.   A spokeswoman said AstraZeneca viewed competitors as 18 months behind in generating similar clinical data. ]]> <![CDATA[APAC Biotech, Diakonos to bring new immunotherapy technology to India]]> https://biospectrumindia.com/news/95/11187/apac-biotech-diakonos-to-bring-new-immunotherapy-technology-to-india.html https://biospectrumindia.com/news/95/11187/apac-biotech-diakonos-to-bring-new-immunotherapy-technology-to-india.html Tue, 26 Jun 2018 17:25:00 +0530 India-Based APAC Biotech and US-Based Diakonos Research sign a first-of-its-kind technology transfer and licensing agreement to bring new immunotherapy technology to India as an advancement of immuno-oncology therapeutics for solid tumors. This new path breaking technology effectively targets and activates the tumor antigen specific CTL-response and is differentiated from peer technologies in its ability to generate durable immunological memory. On the basis of pre-clinical animal data shared by Dr. William Decker and his research team at Baylor College of Medicine, APAC Biotech plans to launch phase II clinical trials in India for advanced brain and pancreatic cancers that have limited treatment options. "We are committed to accelerating the availability of novel immuno-oncology treatments to patients with high unmet medical needs in India and around the globe," said Mr. Arun K. Mehra, CEO, APAC Biotech Pvt. Ltd, the new long-term memory potentiation technology is a highly promising, best-in-class cancer immunotherapy anticipated to improve outcomes even further. APAC management is in talks with large investors for production scale-up of currently approved products and future clinical development trials.  ]]> <![CDATA[IIT-D, DSM Sinochem host workshop on effective manufacturing processes]]> https://biospectrumindia.com/news/95/11186/iit-d-dsm-sinochem-host-workshop-on-effective-manufacturing-processes.html https://biospectrumindia.com/news/95/11186/iit-d-dsm-sinochem-host-workshop-on-effective-manufacturing-processes.html Tue, 26 Jun 2018 16:40:00 +0530 DSM Sinochem Pharmaceuticals (DSP), a global leader in sustainable production of antibiotics, in collaboration with the Indian Institute of Technology (IIT), New Delhi hosted a Sustainability Through Excellence in Manufacturing (STEM) workshop on advanced, clean, sustainable manufacturing and quality techniques to share best practices with participants from leading pharmaceutical companies in Malaysia. The training and education session was attended by approximately 50 participants across the Manufacturing, R&D, Regulatory Affairs, Quality Control/Assurance and Purchasing sectors. Factors that commonly contribute to antimicrobial resistance (AMR) include misuse and overuse of antibiotics, as well as rising industrial pollution, particularly pharmaceutical waste. The discharge of pharmaceutical waste into the environment containing antimicrobial activity can contribute to the growth of AMR, even during the production of these life-saving medicines, endangering their future efficacy. DSP recently organized similar awareness workshops on these issues with industry stakeholders in India, UAE, South Korea, Vietnam, Thailand and Indonesia. Prof. Anurag S. Rathore, Indian Institute of Technology, New Delhi stated: “While antibiotic resistance is a global challenge, solutions need to be determined at national and regional levels. Consumers, stakeholders and the pharmaceutical industry must be more responsive about the environmental implications of antibiotics residues in pharmaceutical effluents. Next to investments to develop new drugs, sustainable manufacturing processes must continue to develop, while ensuring that quality and affordability concerns remain addressed.” ]]> <![CDATA[SMT’s Biodegradable Polymer Coated Stent shows long term safety]]> https://biospectrumindia.com/news/95/11180/smts-biodegradable-polymer-coated-stent-shows-long-term-safety.html https://biospectrumindia.com/news/95/11180/smts-biodegradable-polymer-coated-stent-shows-long-term-safety.html Mon, 25 Jun 2018 17:00:00 +0530 SMT (Sahajanand Medical Technologies Pvt. Ltd.), India’s largest manufacturer of cardiovascular medical stents, today, announced the successful clinical study result of their Biodegradable Polymer Coated Supralimus Sirolimus-Eluting Stent(S-SES) in India.   The result came from an observational and retrospective study that was carried out in 346 patients with a follow-up compliance of 94.5% (327 patients) in seven years. The aim of the study which started in January 2011 was to assess seven-year clinical outcomes of biodegradable polymer coated Supralimus Sirolimus-Eluting stent at Shree B.D. Mehta Mahavir Heart Institute, Surat.   The study was conducted by an independent clinical research organization and was supervised by an independent cardiologist from a remote institute.   Titled as ‘Seven-year clinical outcomes in patients undergoing percutaneous coronary intervention with biodegradable polymer coated sirolimus-eluting stent: Results from a single-center real-world experience’, was presented at EURO PCR 2018 in Paris and was published in Indian Heart Journal this year. The module for the study and population included all real-world patients who were implanted with the S-SES during the said period.   In this clinical study, patient population had high rates of hypertension (34.9%), hypercholesterolemia (31.2%), high complex (61.4%) lesions, and total occluded (4.7%) lesions. The seven year study revealed a long-term safety of the biodegradable polymer coated Supralimus SES in patients.   The principal investigator of the study Dr. Atul Abhyankar, Interventional Cardiologist, said, “The present study is the first ever longest study conducted on biodegradable polymer coated SES. Regardless of the complicated patient population for this study which is usually challenging, the study showed remarkable results. The interesting part of this study is that there is a high percentage of follow-ups of patients which has shown satisfactory and sustained seven –year clinical outcomes suggesting long-term benefits of biodegradable polymer-based SES.”    Mr. Ganesh Sabat, CEO, SMT said, “The result from this study answers a very critical question regarding safety and efficacy of our drug coating technology. The longest ever follow up data also signifies our commitment towards sustained effort on innovation and building a unique product. More importantly it gives scientific proof and strong clinical evidence to the cardiologist community to use our product with confidence. The patients implanted with SMT stents should be free of worries for the rest of their life.” ]]> <![CDATA[ACG launches India’s first one stop packaging solution for OSD drugs]]> https://biospectrumindia.com/news/95/11168/acg-launches-indias-first-one-stop-packaging-solution-for-osd-drugs.html https://biospectrumindia.com/news/95/11168/acg-launches-indias-first-one-stop-packaging-solution-for-osd-drugs.html Sat, 23 Jun 2018 14:35:00 +0530 ACG Films & Foils is the major pharma grade packaging producer in the world. With the launch of the state-of-the-art lamination facility at Shirwal near Pune, ACG has become India’s first in-house complete packaging solution provider for oral solid dosage formulation for the healthcare sector.   ACG Films & Foils business is the first in the country to manufacture primary packaging material from the basic raw material (resin) to the finished films and similarly from raw aluminum foil to the final laminate.   The machine uses superior European technology that allows lacquering, laminating and a combination of both processes, for cold form laminates, blister lid foils and a wide range of specialty aluminum laminates.   The final laminates produced from these machines are used by the pharmaceutical companies for packaging and protecting the medicines in capsules and tablets dosage forms.   In addition, all products of ACG Films & Foils meets international standards such as DMF- USFDA, European Pharmacopeia, Canada -DMF, ISO certifications.   At the launch, S.R. Shivshankar, CEO, ACG Films & Foils said “Our Shirwal facility is now a one-stop solution for pharma companies when it comes to packaging material for capsules and tablets. The launch of our new facility has further strengthened our product portfolio. For packaging operations, there are certain regulatory requirements that need to be fulfilled, such as, safety, protection, suitability, compatibility, quality control, and stability of the packaging material. At ACG we are committed to partner with our customers and provide superior quality and ensure traceability of every batch supplied.”   ACG Films & Foils has two manufacturing facilities catering to the pharmaceutical and allied industries across the globe - one in India and the second one in Brazil.   They manufacture a wide range of high-quality barrier packaging films for the Pharmaceutical, Medical-device and Healthcare industry.   High barrier materials prevent the permeation of water vapour, oxygen, light and gas in and out of the package. ACG Films & Foils has sales offices, slitting units and warehouses spread across the globe. ]]> <![CDATA[WHO prequalifies Strides Shasun's RAS product]]> https://biospectrumindia.com/news/95/11166/who-prequalifies-strides-shasuns-ras-product.html https://biospectrumindia.com/news/95/11166/who-prequalifies-strides-shasuns-ras-product.html Fri, 22 Jun 2018 15:25:00 +0530 Drug firm Strides Shasun has received pre-qualification from the World Health Organization (WHO) for its rectal artesunate product for the pre-referral management of severe malaria.   The pre-qualification from the WHO for the 100mg rectal artesunate suppositories (RAS) has been achieved with support from Medicines for Malaria Venture (MMV) and funding from Unitaid.   This pre-qualification enables countries to procure life-saving RAS with donor funding, thus ensuring increased access to this potentially life-saving intervention.   The company will now leverage its significant presence in Africa to register and distribute the product where needed on the continent. To this end, dossiers have already been submitted in 25 of the countries that could benefit most. ]]> <![CDATA[AstraZeneca receives marketing permission for Durvalumab in India]]> https://biospectrumindia.com/news/95/11160/astrazeneca-receives-marketing-permission-for-durvalumab-in-india.html https://biospectrumindia.com/news/95/11160/astrazeneca-receives-marketing-permission-for-durvalumab-in-india.html Fri, 22 Jun 2018 11:35:00 +0530 AstraZeneca Pharma India Limited recently announced that it has received Import & Market permission for Durvalumab (Imfinzi) in India by the Drug Controller General of India (DCGI). The receipt of this permission paves way for the launch of durvalumab (ImfinziTM) in India, subject to the receipt of further related statutory approvals and licenses. Durvalumab provides a treatment option for patient with locally advanced, unresectable Non-Small Cell Lung Cancer (NSCLC) and metastatic urothelial carcinoma. Durvalumab is a patented product of AstraZeneca global. Gagan Singh, Managing Director, AstraZeneca Pharma India Limited said, “The import and market permission for Durvalumab for unresectable stage III Non-Small Cell Lung Cancer (NSCLC) and locally advanced or metastatic urothelial carcinoma is a significant milestone for patients who have currently limited treatment options. In India, approximately one third of patients with NSCLC are present with Stage III disease and we are excited to bring the first immunotherapy into this setting for patients.” AstraZeneca’s Durvalumab is a part of a new class of immunotherapy drugs known as ‘checkpoint inhibitors’. Some forms of bladder and lung cancer use the PD-L1 protein to evade the immune system. Durvalumab, is a human monoclonal antibody that binds to PD-L1 and blocks the interaction of PD-L1 with PD-1 and CD80, countering the tumour's immune-evading tactics and releasing the inhibition of immune responses. ]]> <![CDATA[Verscend to acquire health care payments company Cotiviti for $4.9 billion ]]> https://biospectrumindia.com/news/95/11149/verscend-to-acquire-health-care-payments-company-cotiviti-for-4-9-billion-.html https://biospectrumindia.com/news/95/11149/verscend-to-acquire-health-care-payments-company-cotiviti-for-4-9-billion-.html Wed, 20 Jun 2018 17:10:00 +0530 Cotiviti Holdings a leading provider of payment accuracy and analytics-driven solutions focused primarily on the healthcare industry and Verscend Technologies, a portfolio company of Veritas Capital (“Veritas”) and a leader in data-driven healthcare solutions, announced today that they have entered into a definitive agreement whereby Verscend has agreed to acquire Cotiviti for $4.9 billion in cash.   Under the terms of the agreement, Cotiviti shareholders will receive $44.75 in cash per share of Cotiviti common stock, and Verscend will assume all of Cotiviti’s outstanding debt, resulting in an enterprise value of approximately $4.9 billion. The offer price represents a 32% premium to Cotiviti’s unaffected share price as of June 4, 2018 and a 136% premium to the initial public offering price of Cotiviti’s common stock.   The combined business will operate as a private healthcare information technology company with unique, data-driven capabilities. Together, the companies are expected to have greater impact in the healthcare IT market by increasing affordability, reducing waste and improving outcomes and quality as well as offer new opportunities to create substantial value for clients, including complementary solutions across multiple intervention points in the payment process.   Veritas Capital has a proven track record of driving growth for companies within the Healthcare Technology IT space, as illustrated by the firm’s recent acquisition of GE Healthcare’s Value-Based Care Division and investments in Truven Health Analytics and Verscend Technologies.   Veritas has a deep understanding of the urgent need to digitalize our healthcare system and brings a culture of intense customer focus and a drive for growth through focused R&D and product innovation.   The transaction, which was unanimously approved by Cotiviti’s Board of Directors, is expected to close during the fourth quarter of 2018. Closing of the transaction is subject to the approval of Cotiviti shareholders and the satisfaction of customary closing conditions, including applicable regulatory approvals.   Advent International has entered into a voting agreement whereby it has agreed to vote shares representing approximately 44% of the Company’s voting power in favor of the transaction. ]]> <![CDATA[Cipla receives USFDA nod to market its HIV drug]]> https://biospectrumindia.com/news/95/11146/cipla-receives-usfda-nod-to-market-its-hiv-drug.html https://biospectrumindia.com/news/95/11146/cipla-receives-usfda-nod-to-market-its-hiv-drug.html Wed, 20 Jun 2018 14:35:00 +0530 Drug major Cipla on Tuesday said it has received approval from the US health regulator to market Efavirenz tablets, used to treat HIV-1 infections in adults.   The Mumbai-based firm has received final nod from the United States Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Efavirenz tablets in 600mg strength, Cipla said in a statement.   The product is available for shipping immediately, it added.   Cipla's product is the generic version of Bristol-Myers Squibb Pharma Company's Sustiva which is indicated in combination with other antiretroviral agents for the treatment of human immunodeficiency virus type 1 infection in adults.   As per IQVIA (IMS Health), Sustiva and its generic equivalents had US sales of around USD 105 million for the 12-month period ending April 2018.   ]]> <![CDATA[TBWA\India wins Grand Prix at ongoing Cannes Lions]]> https://biospectrumindia.com/news/95/11140/tbwaindia-wins-grand-prix-at-ongoing-cannes-lions.html https://biospectrumindia.com/news/95/11140/tbwaindia-wins-grand-prix-at-ongoing-cannes-lions.html Tue, 19 Jun 2018 15:00:00 +0530 TBWA\India’s campaign for Asha Ek Hope Foundation bagged a Grand Prix for Good. The campaign titled ‘Blink to Speak’ created an eye sign language guidebook for patients suffering from non-curable amyotrophic lateral sclerosis (ALS) which weakens muscles and impacts physical function.  The new language solved the problem of communicating with ALS patients as they tend to lose their ability to speak. Instead, they use their hands to communicate. Blink to Speak alphabet has eight letters that can be used to communicate everything. TBWA\ India, CEO, Govind Pandey said “We believe in power of disruptively simple ideas to make a difference to humanity. This was not done for awards. This was a heartfelt intervention from a team that genuinely wanted to help and make a difference,” reported ET Brand Equity. Speaking about the winning entry, jury member Rajesh Mirchandani, chief communication officer of the United Nations Foundation said, “This could go global. Why can’t this be as universal as bread?” He praised the analogue nature and simplicity of the work, adding that it bears one of the markers of true creativity: “the ability to reach those left behind,” reported ET Brand Equity. According to media reports, apart from the Grand Prix, the TBWA\ entry also bagged a Gold Lion in the Pharma category. In the Health & Wellness category, Grey and DDB Mudra bagged a Silver Lion each for work on Mahindra Rise and Stayfree sanitary napkins from Johnson & Johnson, respectively. Last year’s big winner, McCann Health, rounded out the Indian award tally with a Bronze trophy for Kwality Milk.  ]]> <![CDATA[Strides Shasun rises over 3% after USFDA clearance ]]> https://biospectrumindia.com/news/95/11138/strides-shasun-rises-over-3-after-usfda-clearance-.html https://biospectrumindia.com/news/95/11138/strides-shasun-rises-over-3-after-usfda-clearance-.html Tue, 19 Jun 2018 11:20:00 +0530 Drugmaker Strides Shasun is a vertically integrated global pharmaceutical company headquartered in Bengaluru. The company’s stock jumped over 3 per cent on Tuesday after its wholly owned subsidiary Strides Pharma Global received USFDA approval for a generic version of fungal infection drug.   Following the announcement, the stock rose 3.66 per cent to hit a high of Rs 419.70 on the BSE.   The drug, Ketoconazole Tablets USP, 200 mg, is a generic version of Nizoral Tablets, 200 mg, made by Janssen Pharmaceuticals. It belongs to the class of drugs called azole antifungals and is used to treat certain serious fungal infections in the body. It works by blocking the growth of the fungus.   The product, with $7 million market in the US, will be manufactured at the company’s oral dosage facility in Bengaluru and marketed by Strides Pharma in the US market. ]]> <![CDATA[Lupin, Nichi-Iko unite to market biosimilar Etanercept in Japan]]> https://biospectrumindia.com/news/95/11135/lupin-nichi-iko-unite-to-market-biosimilar-etanercept-in-japan.html https://biospectrumindia.com/news/95/11135/lupin-nichi-iko-unite-to-market-biosimilar-etanercept-in-japan.html Mon, 18 Jun 2018 13:25:00 +0530 Pharma major Lupin and Nichi-Iko announced that the two companies have entered into an agreement for the distribution, promotion and sale of Lupin’s recently-filed biosimilar Etanercept (YLB113) in Japan. Developed by YL Biologics, a joint venture between Lupin’s subsidiary Lupin Atlantis Holdings SA (LAHSA) and Yoshindo, the product will be launched by Nichi-Iko after receiving approval from the Pharmaceuticals and Medical Devices Agency (PMDA).   “Etanercept is a key product as we build our biosimilars and complex generics pipeline. Our partnership with Nichi-Iko, takes us a step closer to the launch of our first in-house developed biosimilar that is used to combat a range of severe autoimmune disorders. The market for biologics in Japan is expected to reach $13.5 bn next year. The successful commercialization of our first biosimilar will help our foray into the fast-growing biologics space and also provide patients in Japan access to a highquality affordable alternative," Nilesh Gupta, Managing Director of Lupin stated.   In addition to Japan, Lupin has also submitted the Marketing Authorization Application (MAA) for its Etanercept biosimilar to the European Medicines Agency (EMA).   The indications targeted for approval are Rheumatoid Arthritis (RA), Psoriatic Arthritis, Ankylosing Spondylitis, Axial spondyloarthritis, Non-radiographic Axial Spondyloarthritis and Plaque Psoriasis.   The ex-US market for Etanercept is estimated at $4 billion in Japan and Europe, along with other regulated and emerging markets. ]]> <![CDATA[Dr. Reddy's launches generic Suboxone in the U.S. Market]]> https://biospectrumindia.com/news/95/11129/dr-reddys-launches-generic-suboxone-in-the-u-s-market.html https://biospectrumindia.com/news/95/11129/dr-reddys-launches-generic-suboxone-in-the-u-s-market.html Fri, 15 Jun 2018 17:05:00 +0530 Dr. Reddy’s Laboratories Ltd. has received final approval from the U.S. Food and Drug Administration (USFDA) and is launching Buprenorphine and Naloxone Sublingual Film, 2 mg/0.5 mg, 4 mg/1 mg, 8 mg/2 mg, and 12 mg/3 mg, a therapeutic equivalent generic version of Suboxone® (buprenorphine and naloxone) sublingual film, in the United States market. The product is being launched with an approved Risk Evaluation and Mitigation Strategy (REMS) Program.   Buprenorphine and naloxone are used to treat adults with opioid dependence/addiction. Buprenorphine helps suppress withdrawal symptoms caused by discontinuation of opioid drugs, and naloxone reverses and blocks the effect of opioids. This combination of medications is used as part of a complete treatment program including prescription monitoring, counseling, and psychosocial support.     In a statement released earlier today by the USFDA, Commissioner Scott Gottlieb, M.D., explained, “The FDA is taking new steps to advance the development of improved treatments for opioid use disorder, and to make sure these medicines are accessible to the patients who need them. That includes promoting the development of better drugs, and also facilitating market entry of generic versions of approved drugs to help ensure broader access.”   “With opioid addiction becoming increasingly prevalent in America, the full approval and launch of our generic equivalent of Suboxone® could not have come at a more critical time to help patients,” explains Alok Sonig, Chief Executive Officer, Developed Markets. “We are excited to be launching this important product that will help enable patients to prevail over this insidious disease.”     Sonig adds. “This approval is an important milestone for our company and a testament to our commitment to bring affordable generic medicines to market for patients. Our company will continue to look for opportunities to acquire and manufacture assets that accelerate access to innovative and affordable medicines for patients.”   The Suboxone® brand had U.S. sales of approximately $1.86 billion MAT for the most recent twelve months ending in April 2018 according to IMS Health. ]]> <![CDATA[Strategic acquisition of GlobalSpace in Miljon Medi APP]]> https://biospectrumindia.com/news/95/11127/strategic-acquisition-of-globalspace-in-miljon-medi-app.html https://biospectrumindia.com/news/95/11127/strategic-acquisition-of-globalspace-in-miljon-medi-app.html Fri, 15 Jun 2018 15:00:00 +0530 GlobalSpace Technologies Limited a fast-growing new-age technology company today announced the acquisition of 70.80% stake in Miljon Medi APP for an undisclosed sum.   Miljon Medi APP is a health tech startup with B2B Digital Platform (“Platform”) that connects Generics pharmaceutical manufacturers to the entire Pharma channel till retail chemist. Company claims to have some of the leading Generics Manufacturers already on the Platform with an existing network of around 73 distributors & 9380 Chemists as its active users. Company’s vision is to enable quality & certified generics reach the last mile so as to benefit the patients.   For GlobalSpace, it’s a strategic acquisition which would further consolidate its vision of creating truly integrated digital healthcare ecosystem. Company is having thought leadership in creating digital platform for Pharma sales force & Doctors.   Commenting on the transaction, Mr. Krishna Singh, MD, GlobalSpace said “This is a synergistic acquisition for us, we have already built an evolved digital platform for Pharma distribution including ERP, Mobile & Web app, it would provide the much-needed technical scalability & viability to Miljhon Mediapp. Merging GlobalSpace’s tech platform with Miljhon’s existing network would surely provide us the initial impetus to grow this platform to be India’s largest Pharma channel network. ]]> <![CDATA[Transasia Bio-Medicals Ltd receives ICMED 13485 certification]]> https://biospectrumindia.com/news/95/11123/transasia-bio-medicals-ltd-receives-icmed-13485-certification.html https://biospectrumindia.com/news/95/11123/transasia-bio-medicals-ltd-receives-icmed-13485-certification.html Thu, 14 Jun 2018 17:30:00 +0530 Transasia Bio-Medicals Ltd., India’s leading In-vitro DiagnosticCompany has announced that they have been recently certified by ICMED 13485 - Indian Certification for Medical Devices (ICMED) Certification Scheme. This is in addition to the latest ISO 9001:2015 certification. The company has been audited and registered by UL India Private Limited. ICMED is the country’s first indigenous quality assurance system for India manufactured medical devices. It is an initiative of Association of Indian Medical Device Industry (AIMED) in collaboration with the Quality Council of India (QCI) and the National Accreditation Board forCertification Bodies (NABCB). ICMED is aimed at enhancing patient safety, by providing the product credentials to manufacturers and is intended to significantly eliminate trading of sub-standard products or devices. Transasia received the ICMED 13485 certification for its manufacturing facilities at Mumbai, Daman and Baddi. All the three facilities were successfully audited for quality compliance for the design, development, manufacture, installation and service of IVD analyzers and reagentsused in diagnosis. “We are glad that alongwith all existing national and international quality certifications we are now also certified by India’s very own QA system. We are committed to always deliver innovative products of the highest quality and consistent efficiency. The ICMED 13485 alongwith the latest ISO 9001:2015 certification is an assurance of our focus on continuousimprovement of our systems and processes, leading to greater customer satisfaction.” said Transasia’s Chairman & Managing Director, Suresh Vazirani. He further added, “The Indian medical device industry has long needed its own quality assessment system. I am grateful to AIMED, QCI and NABCB for their joint efforts in making ICMED 13485 a reality. It a boon for IVD manufacturers like us, as it will bring down the substantial time and monetary investment to obtain globally accepted quality certifications. It will also give a boost to the ‘make in India’ focus on this industry. From the customer’s perspective, it will help in assuring standardized products.” For over three decades, Transasia has been delivering the highest quality of IVD instruments and reagents, not just in India but also globally. Infact it was the first company to attain the CE certification and enter the European market, way back in the 1990s. Over the years, Transasiahas been successfully certified as compliant and adherent to all international regulatory norms, and has well established documentation and procedures. ]]> <![CDATA[Lupin brings generic antibiotic inhalation solution in US market]]> https://biospectrumindia.com/news/95/11115/lupin-brings-generic-antibiotic-inhalation-solution-in-us-market.html https://biospectrumindia.com/news/95/11115/lupin-brings-generic-antibiotic-inhalation-solution-in-us-market.html Thu, 14 Jun 2018 10:00:00 +0530 Drug firm Lupin today said it has launched its antibiotic Tobramycin inhalation solution in the US market.   The company has launched the product as it has received an approval from the US Food and Drug Administration (USFDA) earlier, Lupin said.   The company's Tobramycin Inhalation Solution USP, 300 mg/5 ml, is the generic version of Novartis Pharmaceuticals Corporation's Tobi 300 mg/5 ml, it added.   The product is indicated for the management of cystic fibrosis patients with P aeruginosa, Lupin said.   As per IQVIA MAT April 2018 data, Tobramycin inhalation solution USP, 300 mg/5 ml, had annual sales of nearly USD 99 million in the American market, it added. ]]> <![CDATA[ CPhI & P-MEC India 2018 shifts to Indian capital]]> https://biospectrumindia.com/news/95/11103/-cphi-p-mec-india-2018-shifts-to-indian-capital.html https://biospectrumindia.com/news/95/11103/-cphi-p-mec-india-2018-shifts-to-indian-capital.html Tue, 12 Jun 2018 11:05:00 +0530 CPhI & P-MEC India (December 10-14, 2018) organised by UBM announces that the 12th edition of Asia’s largest Pharma exhibition is moving to the India Expo Mart, New Delhi.   The new venue will see the exhibition now hosted in a single venue, bringing it closer to the Indian regulatory and legislative capital. New Delhi is also the country’s main international transport hub and will encourage an increased international attendance. In total, more than 50,000 people from 122 countries are expected, along with nearly 1,500 exhibitors.    CPhI & P-MEC India comes with the backing of the Delhi-based Pharmaceuticals Export Promotion Council of India (Pharmexcil) – the organisation behind key Government international strategies such as ‘Made in India’. Mr. Yogesh Mudras, Managing Director, UBM India commented “the shift to the Delhi-NCR region, in close geographical proximity to the policy makers, consulates and government bodies will enhance our community building efforts, as well as the creation of a robust pharma eco-system.”    Government investment plans – including a US$ 640 million venture capital fund to boost drug discovery and strengthen pharmaceutical infrastructure – and the ‘Pharma Vision 2020’ initiative are creating new benefits for government engagement with industry.    UBM cited rising international interest in the event as a key factor in the move, with numbers of both international and domestic exhibitors requiring a far bigger venue – and on a single site.    The venue change is also seen as a boost to domestically focused markets by bringing a wider remit of attendees and greater access to national regulatory pathways. The country registers the second largest Abbreviated New Drug Applications (ANDAs) globally and is the world’s leader in Drug Master Files (DMFs) applications, so access to regulatory expertise has never been greater.    The 2018 edition will also feature India Pharma Week (returning for a third year), with 10 unique events and activities spanning the Indian Capital. These include dynamic engagements such as the Pharma Leader’s Golf Pre-Connect Congress, Plant Visits, Women in Pharma – Power Breakfast, India Pharma Awards, Networking Evening, and a closed-door CEO Roundtable, amongst others.     The ultimate goal of all these intertwined events is to help nurture a complete pharma ecosystem in India and better enable networking with the country’s corridors of power. In fact, the recent CPhI Global Pharma Index showed India represents global pharma’s second fastest growing market and praised the Delhi based regulator, the CDSCO (Central Drugs Standard Control Organization) for its efforts in introducing a certification programme and initiatives for increased compliance. Impressively, 52% of international respondents believed the CDSCO is moving toward comparability with the regulatory standards of the EMA and FDA.     ]]> <![CDATA[Cipla, Unitaid join hands to reduce HIV drug price]]> https://biospectrumindia.com/news/95/11101/cipla-unitaid-join-hands-to-reduce-hiv-drug-price.html https://biospectrumindia.com/news/95/11101/cipla-unitaid-join-hands-to-reduce-hiv-drug-price.html Mon, 11 Jun 2018 19:55:00 +0530 Cipla and Unitaid have inked a pact to lower the price of the first combination therapy (containing co-trimoxazole, isoniazid and vitamin B6) that prevents opportunistic infections in people living with HIV. Under this agreement, Cipla will reduce the ceiling price of the medicine by more than 30 per cent from $ 3 to $ 1.99 per person, per month, for all public-sector procurers in low and middle-income countries. The price of the product is expected to come down more as governments and international funding bodies procure larger quantities for their HIV treatment programmes.The combination therapy is a once-daily pill that protects in three ways against TB, the leading cause of death among people with HIV, and against other life-threatening bacterial, and protozoan infections. ]]> <![CDATA[J&J announces Health for Humanity report]]> https://biospectrumindia.com/news/95/11100/jj-announces-health-for-humanity-report.html https://biospectrumindia.com/news/95/11100/jj-announces-health-for-humanity-report.html Mon, 11 Jun 2018 19:40:00 +0530 Johnson & Johnson has released its 2017 Health for Humanity Report, demonstrating its approach and the considerable progress it has made toward an ambitious social, environmental and governance commitment to advance the Company’s mission to drive better health for all. The report also highlights Johnson & Johnson’s pioneering public health initiatives in India, with a special focus on supporting the country’s efforts to eradicate deadly diseases such as tuberculosis (TB), progress in maternity and infant care and the company’s initiatives towards enhancing workplace diversity & inclusion. “Johnson & Johnson works every day to ensure the next generation is healthier than the last,” said Alex Gorsky, Chairman and Chief Executive Officer, Johnson & Johnson. “Our work pushes for healthier societies and serves as a reminder that our job is not yet done. We must continue to raise the bar for ourselves and for the healthcare industry at large, so we can continue to earn our place in people’s hearts and minds everywhere.” The following reflect 2017 highlights for India:   Maintaining our commitment to eradicating and preventing disease – collaborating for a TB-free India   Johnson & Johnson is a committed partner to the Government of India for combating drug-resistant TB at every level. To date, the company has donated approximately 11,000 courses of bedaquiline, the first new TB treatment in nearly 50 years, as part of a Donation Program with the United States Agency for International Development (USAID), its Compassionate Use Programs and a Conditional Access Program (CAP). Beyond this, Johnson & Johnson has partnered at the central and state levels to ensure appropriate use of medications, training more than 4,000 health care workers on the clinical management of TB and multi-drug resistant- (MDR-) TB; provided around 35,000 X-ray tests and 20,000 molecular tests to improve access to diagnosis; and helped raised awareness about TB among nearly 11 million people at the community level.   Further, Johnson & Johnson is working closely with scientists from the Council of Scientific & Industrial Research’s Institute of Microbial Technology (CSIR-IMTECH), based in Chandigarh.  The research and discovery program is aimed at exploring the development of next-generation treatment regimens to tackle multidrug-resistant TB, as well as new molecular entities to treat all TB patients.   Reflecting on the progress of initiatives in India, Sanjiv Navangul, Managing Director, Janssen, pharmaceutical division of Johnson & Johnson India said, “For over seventy years, India has been an important part of Johnson & Johnson’s efforts to ensure health for humanity around the world. We are driven by the belief that patients are waiting and there is no time to waste, and this report, which highlights the progress we have made over the last year, underlines our deep commitment to solving some of India’s greatest health challenges”.   Reimagining how care is delivered   Introduced GenH, a global social venture competition bringing ideas from more than 54 countries, harnessing the power of innovators and entrepreneurs to design locally-tailored and globally-relevant solutions for some of the world's toughest health problems, and offering mentorship and financial prizes to the winners for establishing those ventures in countries such as India, Ghana, and Brazil. Achieved broad expansion of mMitra, a groundbreaking mobile-messaging program in India that sends vital health information to expectant and new moms living in low-income urban communities. The program has been cited by the World Health Organization and others as a global example of a scaled digital health program.   Promoting lifelong health and wellbeing, and environmental health   Johnson & Johnson India has been committed to the well-being of its workforce implementing programs for several decades now. Case in point: Johnson & Johnson’s manufacturing facility in Mulund (Mumbai) has had a creche for over thirty years now. Today, the company offers such best-in-class benefits as on-site health centres, height-adjustable tables for the health-conscious; parental leaves for birth or adoption, and family support through programs such as the Nurturing Family Bonds.   Speaking at the announcement, Vikas Srivastava, Managing Director, Consumer, Johnson & Johnson India said, “We at Johnson & Johnson India are committed to supporting the health and well-being of our employees and their families. We have also introduced family-friendly policies which make it possible for employees to more easily balance family and work, and to fulfill their obligations. For new mothers, we were amongst the first organizations, six years ago, to offer 26 weeks of maternity leave.  In August 2017, we introduced a new global standard for Parental Leave, where our employees across the globe - including India - are eligible to take a minimum of eight weeks paid parental leave for birth or adoption.” Looking across all Johnson & Johnson’s business practices, the Company shares important disclosure about how it supports good health for patients, consumers, employees and local communities on a global scale. The report tracks how Johnson & Johnson is striving to eradicate and prevent disease, reimagine how care is delivered, and put a healthy mind, body and environment within reach of all people around the world. ]]> <![CDATA[MedGenome's OncoPept wins Best Overall Genomic Solution Award]]> https://biospectrumindia.com/news/95/11099/medgenomes-oncopept-wins-best-overall-genomic-solution-award.html https://biospectrumindia.com/news/95/11099/medgenomes-oncopept-wins-best-overall-genomic-solution-award.html Mon, 11 Jun 2018 17:05:00 +0530 MedGenome's OncoPept platform of advanced genomics-based solutions designed to accelerate cancer immune-oncology research, was named the winner of the 2018 MedTech Breakthrough Awards for 'Best Overall Genomics Solution.' OncoPept platform is used by researchers to help identify biomarkers aimed at delivering personalized therapies including more durable, improved and responsive cancer immunotherapy treatments. It offers a personalized cancer therapy approach leveraging a novel T cell receptor binding algorithm to predict personalized cancer vaccine candidates, and provides a high-throughput multi-dimensional view of the tumor microenvironment using NGS (Next Generation Sequencing) based solutions. "We thank the MedTech Breakthrough Awards for recognizing our research solutions that benefit a global community of patients dealing with various types of cancer.  As a leading genomics-based research company, it is our mission to improve health worldwide by developing deep insights into diseases, ultimately leading to treatments and – eventually – cures," said Dr. Amitabha Chaudhuri, VP, Research and Development at MedGenome. "The genomics market is incredibly competitive, and we are thrilled to recognize industry innovator, MedGenome, for their breakthrough OncoPept cancer immunotherapy biomarker platform," said James Johnson, Managing Director at MedTech Breakthrough. "MedGenome's solutions are delivering a truly personalized cancer therapy approach, and we are excited to recognize their platform as our 'Best Overall Genomics Solution' award winner in the 2018 MedTech Breakthrough Awards program." The MedTech Breakthrough Awards recognize the top companies, people, platforms and products in the health, fitness and medical technology industries today. The mission of the MedTech Breakthrough Awards is to honor excellence and recognize the creativity, hard work and success of health and medical technology companies, services and products. With over 3,000 global nominations this year for the MedTech Breakthrough Awards, the competition was incredibly fierce. Notable winners from other categories include GE, WebMD, FitBit, Philips, 23andMe, Humana, Abbott, Apple and an impressive list of top companies and startups in the MedTech industry.   ]]> <![CDATA[Natco Pharma introduces generic Posaconazole injection in India]]> https://biospectrumindia.com/news/95/11098/natco-pharma-introduces-generic-posaconazole-injection-in-india.html https://biospectrumindia.com/news/95/11098/natco-pharma-introduces-generic-posaconazole-injection-in-india.html Mon, 11 Jun 2018 16:55:00 +0530 Natco Pharma has launched a generic version of Posaconazole Injection, 300 mg/16.7ml, under its brand POSANAT.   This is the first time an injection version of this drug is available in India. POSANAT will be available in 18 mg/ml strength, a formulation for intravenous (IV) use.   Posaconazole Injection is sold in the USA market by Merck under its brand name of NOXAFIL.   Posaconazole injection is an antifungal agent & used in patients who are at high risk of developing infections due to being severely immunocompromised, such as associated with stem cell transplant or from chemotherapy.   The stock ended at Rs786.75 up by Rs21.8 or 2.85% from its previous closing of Rs764.95 on the BSE.   The scrip opened at Rs762 and touched a high and low of Rs792.50 and Rs755.90 respectively.   Natco Pharma, a leading domestic player in the oncology and Hepatitis C, derived 22% of its Q4FY18 sales from domestic markets of which 52% came from oncology business. The company derived 69% revenue from international formulations and rest 8.4% from in Q4FY18.   Domestically, the company is expanding presence in speciality segment with launches of HEPCINAT and HEPCINAT LP for Hepatitis C. It will be focusing on high-value and first-to-market generic drugs in India, Brazil and Canada going ahead. The company has launched two new divisions in India i.e. Cardiology and Diabetology. ]]> <![CDATA[Alembic Pharma gets USFDA permission for anti-depression drug]]> https://biospectrumindia.com/news/95/11093/alembic-pharma-gets-usfda-permission-for-anti-depression-drug.html https://biospectrumindia.com/news/95/11093/alembic-pharma-gets-usfda-permission-for-anti-depression-drug.html Mon, 11 Jun 2018 12:00:00 +0530 Alembic Pharmaceuticals has received the US health regulator's nod for Bupropion Hydrochloride tablets, used for treatment of major depressive disorder.   "The company has received approval from the United States Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Bupropion Hydrochloride tablets," Alembic Pharmaceuticals said in a BSE filing.   The approval is for strengths of 75 mg and 100 mg.   The approved product is therapeutically equivalent to the reference listed drug product (RLD) Wellbutrin tablets of GlaxoSmithKline LLC.   Quoting IMS December 2017 data, the company said Bupropion Hydrochloride tablets had an estimated market size of USD 37 million. ]]> <![CDATA[Cipla, Eli Lilly sign distribution agreement for diabetes drug]]> https://biospectrumindia.com/news/95/11089/cipla-eli-lilly-sign-distribution-agreement-for-diabetes-drug.html https://biospectrumindia.com/news/95/11089/cipla-eli-lilly-sign-distribution-agreement-for-diabetes-drug.html Fri, 08 Jun 2018 18:30:00 +0530 Cipla has entered into a partnership with Eli Lilly and Co (India) Pvt. Ltd., a 100 per cent subsidiary of Eli Lilly and Company, a global multinational pharmaceutical leader, for the marketing and distribution of Lilly’s Basaglar (insulin glargine injection) in India. Under this agreement, Lilly’s Basaglar will be marketed and distributed in India by Cipla. It expects to start commercialising Basaglar in India by end of the year 2018. Diabetes continues to be a focus area for Cipla and with the launch of strong brand like Basaglar, Cipla will be at the forefront of providing a holistic diabetes care with the most comprehensive portfolio across orals and injectables. Cipla’s focus continues to revolve around care continuum approach for the patients it serves and create greater access to high quality treatment and medication. According to Eli Lilly, this strategic partnership leverages the company’s commitment to bring innovation to people suffering from diabetes in India and Cipla’s strong on-ground footprint across the country. ]]> <![CDATA[USFDA approves Aurobindo’s heartburn drug]]> https://biospectrumindia.com/news/95/11087/usfda-approves-aurobindos-heartburn-drug.html https://biospectrumindia.com/news/95/11087/usfda-approves-aurobindos-heartburn-drug.html Fri, 08 Jun 2018 18:20:00 +0530 Aurobindo Pharma has received final approval from the US health regulator to manufacture Omeprazole delayed-release tablets OTC, 20mg, used in the treatment of frequent heartburn. The approved product is a generic equivalent of AstraZeneca's Prilosec tablets. Omeprazole tablets are indicated for the treatment of frequent heartburn (occurring two or more days a week). This is the 141st ANDA (abbreviated new drug application), including 20 tentative approvals, to be approved out of unit VII formulation facility in Hyderabad used for manufacturing oral products. According to Aurobindo Pharma, the estimated market size of Prilosec OTC tablets is $222 million for the twelve months ending March 2018. ]]> <![CDATA[Pharma experts address quality as a critical issue]]> https://biospectrumindia.com/news/95/11077/pharma-experts-address-quality-as-a-critical-issue.html https://biospectrumindia.com/news/95/11077/pharma-experts-address-quality-as-a-critical-issue.html Wed, 06 Jun 2018 17:05:00 +0530 (L-R) Dr. Ajit Dangi (President & CEO, Danssen Consulting), Deepshika Jakate (Regional Quality Head-South Asia, GSK Pharmaceuticals Ltd), Ashwani Sood (Sr. Director- Industrial Affairs, Sanofi India Ltd.), Annaswamy Vaidheesh (President, OPPI), Deepnath Roy Chowdhury (President, IDMA), Dr. Sanjit Singh Lamba (Managing Director, Eisai Pharmaceuticals) and Jaidev Rajpal (Partener, McKinsey)   Government officials, industry representatives, industry associations and patient groups met recently to address quality in the pharmaceutical industry. India’s reputation as ‘Pharmacy to the World’ makes it incumbent upon us to achieve the acceptable quality standards across the entire value chain, from R&D to the point it reaches the patient buying medicine from the pharmacy. In collaboration with the Department of Pharmaceuticals (DoP), Ministry of Chemicals and Fertilisers, all the major industry associations, viz, the Indian Pharmaceutical Alliance (IPA), the Indian Drug Manufacturers Association (IDMA) and the Organisation of Pharmaceutical Producers of India (OPPI) participated in a Quality Summit to set an agenda that would: Align on the importance of setting and adopting best-in-class global quality standards for the pharmaceutical industry; Bring all stakeholders together – regulators, industry and governments, both state and central – to create the enabling conditions for achieving this goal, and Define the quality roadmap for India The gamut of issues covering quality, ranging from labelling to packaging and storage, were discussed at the summit. According to a 2015 study by the Uttar Pradesh Department of Food Safety and Drug Administration, 38 percent of medicines are not effective because of low quality. This highlights the need for a baseline quality standard across the spectrum from the laboratory to the market. Commenting on the deliberations in the Quality Summit, A. Vaidheesh, President, OPPI said. “Quality is the differentiator and a key factor in competitive advantage. It is a continuous journey, not a destination. We have to keep working at it in sustained fashion. Quality of medicines are pivotal in delivering patient care and the entire pharmaceutical industry has come together to stress the importance of quality in delivering responsible and safe patient care.” Deepnath Roy Chowdhury, National President IDMA, was also categorical in his position on the importance of quality medicines in India. “Our industry has taken the lead in pledging support towards making global quality medicines,” he said. “We will do our utmost in maintaining our country’s leadership in providing quality affordable medicines and ensure that Indian Pharmaceuticals continues to be the Nation’s Pride”. ]]> <![CDATA[FGI confers Sun Pharma with CSR award]]> https://biospectrumindia.com/news/95/11073/fgi-confers-sun-pharma-with-csr-award.html https://biospectrumindia.com/news/95/11073/fgi-confers-sun-pharma-with-csr-award.html Wed, 06 Jun 2018 15:25:00 +0530 Sun Pharmaceutical Industries Ltd has recently received a Corporate Social Responsibility (CSR) Award from the Federation of Gujarat Industries (FGI) for outstanding contribution in the field of CSR. The award was presented to Sun Pharma for its CSR efforts in the areas of healthcare, education, safe drinking water, sanitation & hygiene, environment conservation, rural development, disaster relief and malaria elimination. The Company’s CSR initiatives benefited around 1.2 million people from 3800 villages spread over 11 states in India last year (2017-18). The award was presented by Maneka Gandhi, Hon’ble Union Cabinet Minister for Women & Child Development, Govt. of India at the 15th FGI Awards function organised at Vadodara, Gujarat. On behalf of Sun Pharma, the award was received by Dr. Azadar Khan, Sr. VP - corporate relations. Earlier in the year, Sun Pharma was conferred with the ‘CSR Leadership Award’ for making a positive impact in the lives of marginalised & backward communities. The award was given by World CSR Congress. ]]> <![CDATA[USFDA approves Mylan and Biocon’s Fulphila]]> https://biospectrumindia.com/news/95/11065/usfda-approves-mylan-and-biocons-fulphila.html https://biospectrumindia.com/news/95/11065/usfda-approves-mylan-and-biocons-fulphila.html Tue, 05 Jun 2018 10:10:00 +0530 Mylan N.V.  and Biocon Ltd. have announced that the U.S. Food and Drug Administration (FDA) has approved Mylan’s Fulphila (pegfilgrastim-jmbd), a biosimilar to Neulasta (pegfilgrastim), co-developed with Biocon. Fulphila has been approved to reduce the duration of febrile neutropenia (fever or other signs of infection with a low count of neutrophils, a type of white blood cells) in patients treated with chemotherapy in certain types of cancer. Fulphila is the first FDA-approved biosimilar to Neulasta and the second biosimilar from Mylan and Biocon’s joint portfolio approved in the U.S. Mylan anticipates launching Fulphila in the coming weeks, representing the first alternative, more affordable treatment option to Neulasta for oncology patients. A suite of patient services also will be available at launch to further support patients and caregivers with treatment.  Mylan CEO Heather Bresch commented: “I couldn’t be prouder of this approval for Fulphila, the first alternative option for pegfilgrastim approved in the U.S., as it represents an important milestone for patients and further demonstrates Mylan’s continued fight to expand access to medicine. FDA’s approval of this product, as well as the agency’s continued focus on biosimilars, mark crucial steps towards lowering treatment costs and providing alternative options for patients. As a leading supplier of cancer medicines in the U.S, Mylan is committed to offering affordable and accessible solutions for patients with cancer at every step of their journey. Enhancing access to treatment has always been our top priority and what we’ll continue to deliver to the healthcare system in the U.S. and beyond.” Mylan President Rajiv Malik added: “Today’s approval of Fulphila represents a meaningful step forward in the affordability and accessibility of cancer care in the U.S. It also is yet another confirmation of Mylan’s deep scientific, clinical, regulatory and intellectual property capabilities, which are widely recognized in the industry and bolster Mylan’s reputation as a partner of choice in the global effort to bring complex medicines to market. The approval of Fulphila, the first biosimilar to Neulasta, joins other recent examples such as the approval of Ogivri, the first biosimilar to Herceptin, in the growing portfolio of complex medicines that Mylan is making available for patients who need them. We’re pleased to reach this important milestone in partnership with Biocon and proud of the progress of our biosimilars program. We look forward to launching Fulphila and continuing to increase access to more affordable treatments.” As a global leader in the development and manufacturing of complex products, Mylan has a portfolio of 20 biosimilar and insulin analog products – one of the industry’s largest and most diverse portfolios – and deep experience with more than 60 marketing authorizations for biosimilar products worldwide. Mylan was the first company to receive FDA approval of Ogivri, a biosimilar to Herceptin (trastuzumab), in late 2017 and has continued to obtain regulatory approvals for biosimilar trastuzumab in nearly 30 additional countries around the world. Biocon CEO & Joint Managing Director, Dr. Arun Chandavarkar, said: “It’s a moment of great pride to be the first to receive approval for a biosimilar pegfilgrastim by the USFDA. This important milestone comes soon after our achievement of being the first to receive USFDA approval for biosimilar trastuzumab. It represents a further endorsement of the Biocon-Mylan partnership’s ability to successfully develop complex molecules to exacting quality and regulatory standards. This approval expands our oncology portfolio for the benefit of cancer patients and supports our mission to improve access to high quality, affordable biopharmaceuticals globally.” The approval for Fulphila was based on a comprehensive package of analytical, nonclinical and clinical data, which confirmed that the product is highly similar to Neulasta. The data demonstrated that there were no clinically meaningful differences between the biosimilar product and Neulasta in terms of safety, purity and potency.  Neulasta had U.S. sales of $4.2 billion for the 12 months ending March 31, 2018, according to IQVIA. Fulphila is not indicated for the mobilization of peripheral blood progenitor cells for hematopoietic stem cell transplantation. Do not administer Fulphila to patients with a history of serious allergic reactions to pegfilgrastim or filgrastim. Splenic rupture and sickle cell crisis, including fatal cases, can occur following the administration of Fulphila. Discontinue Fulphila in patients with Acute Respiratory Distress Syndrome and consider dose reduction or interruption in patients with glomerulonephritis. The most common adverse reactions are bone pain and pain in extremity. Ogivri is approved for the treatment of HER2-overexpressing breast cancer and metastatic stomach cancer (gastric or gastroesophageal junction adenocarcinoma). It may cause cardiomyopathy, infusion reactions, embryo-fetal toxicity and pulmonary toxicity. Cardiomyopathy: Ogivri can result in subclinical and clinical cardiac failure manifesting as CHF, and decreased LVEF, with greatest risk when administered concurrently with anthracyclines. Evaluate cardiac function prior to and during treatment. Discontinue Herceptin for cardiomyopathy. Infusion Reactions, Pulmonary Toxicity: Discontinue Herceptin for anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndrome. Embryo-Fetal Toxicity: Exposure to Herceptin during pregnancy can result in oligohydramnios, in some cases complicated by pulmonary hypoplasia and neonatal death. Advise patients of these risks and the need for effective contraception. Bringing Access to Biologics Biologic drugs, like Neulasta, represent a large and increasing portion of the overall prescription drug market. They are important in the treatment of many chronic and acute diseases, including cancer. However, these drugs can cost far more than traditional prescription drugs, and their cost can prohibit access. According to a survey from the American Society for Clinical Oncology, more than half (56%) of respondents said they were very or somewhat concerned they could afford treatment. Biologics accounted for 70% of drug spending growth between 2010 and 2015. Biosimilar medicines are deemed by FDA to be highly similar to an already-approved biologic product. They fill an urgent and unmet need for more affordable alternatives to biologic therapies, increasing access and providing savings for patients and the overall healthcare system. It is projected that biosimilars will generate a savings of $54 billion in direct spending on biologic drugs in the U.S. between 2017 and 2026. ]]> <![CDATA[TMH team presents Biocon’s Nimotuzumab study results at ASCO 2018]]> https://biospectrumindia.com/news/95/11061/tmh-team-presents-biocons-nimotuzumab-study-results-at-asco-2018.html https://biospectrumindia.com/news/95/11061/tmh-team-presents-biocons-nimotuzumab-study-results-at-asco-2018.html Mon, 04 Jun 2018 16:45:00 +0530 Biocon Ltd., Asia's premier biopharmaceuticals company, recently announced that a Tata Memorial Hospital (TMH), Mumbai team led by Dr Kumar Prabhash, Head, Solid Unit, Medical Oncology presented the results of a study with Biocon’s novel biologic molecule Nimotuzumab at the 2018 American Society of Clinical Oncology (ASCO) Annual Meeting held in Chicago from June 1-5. This 536- patient study was conducted by Dr. Vanita Noronha, Dr. Amit Joshi, Dr. Vijay Patil, Dr. A. K. D’cruz, Dr. Sarbani Lasker, Dr. J. P. Agarwal with Dr. Kumar Prabash as the lead investigator, over a period of 6 years. The study successfully met the primary endpoint of median progression free survival which was three times than that of standard of care. The investigator-initiated study, one of the largest randomized clinical studies on head and neck cancer patients in India, evaluated the efficacy and safety of administering Nimotuzumab during concurrent chemo-radiation in locally advanced head and neck squamous cell carcinoma (LAHNSCC). Adult patients of LAHNSCC were randomized 1:1 into either radical radiotherapy with weekly cisplatin (CRT arm) or the same schedule of chemo-radiation with weekly Nimotuzumab (NCRT arm). The primary endpoint of the study was ‘progression free survival’, while other key secondary endpoints were ‘disease free survival’, ‘duration of loco-regional control’ and overall survival. The study successfully met the primary endpoint Median progression free survival of 60.3 months in NCRT arm as compared to 21 months in CRT arm which was statistically significant. We believe Nimotuzumab, will benefit a large number of head and neck cancer patients in India. Nimotuzumab with chemo-radiotherapy will provide an  alternate therapeutic option in the armamentarium against locally advanced head and neck cancer,” said Principal investigator, Dr Kumar Prabhash, Head, Solid Unit, Medical Oncology, TMH. "As the first company in India to successfully introduce a novel targeted anti-EGFR biologic,  for the treatment of head and neck cancers in India, the positive results from this large randomized study are a significant milestone in Biocon’s ongoing efforts to establish Nimotuzumab’s ‘best-in-class’ status for the treatment of one of the most common forms of cancer in the country. We are pleased that ASCO has recognized the superior efficacy and safety profile of Nimotuzamab and the difference it can make in improving clinical outcomes of head and neck cancer patients by its addition to the standard of care,” said Suresh Subramanian, Senior Vice President & Head, Branded Formulations-India, Biocon. Nimotuzumab is the first indigenously produced novel biologic developed by Biocon and introduced in India as  BIOMAb EGFR® for head and neck cancer in 2006. Head and neck cancer is one of the leading cancers in India. Over 16 new patients are diagnosed with this specific cancer every hour in India, and 12 deaths recorded every hour*. Dr Kumar Prabhash and his team has conducted this large patient study over a period of 6  years to establish the superior profile of Nimotuzumab and the difference it can make to patients. The results also showed that the addition of Nimotuzumab to chemo-radiotherapy improved the locoregional control rate, disease free survival and had a trend towards improvement in overall survival. ]]> <![CDATA[Lupin launches oral drug Solosec in US]]> https://biospectrumindia.com/news/95/11056/lupin-launches-oral-drug-solosec-in-us.html https://biospectrumindia.com/news/95/11056/lupin-launches-oral-drug-solosec-in-us.html Sun, 03 Jun 2018 19:10:00 +0530 Pharma major Lupin has recently announced the launch of Solosec (secnidazole) 2g oral granules in the US market, having received an approval from the United States Food and Drug Administration (FDA) earlier. Lupin’s Solosec (secnidazole) 2g oral granules is a 5-nitroimidazole antimicrobial agent indicated for the treatment of bacterial vaginosis (BV) in adult women. Solosec, the first new oral antibiotic to treat BV in more than a decade, is designed to deliver a full course of therapy in a single 2g oral dose and is the first and only single-dose oral therapy for BV, the most common vaginal infection in the US among women of childbearing age. The FDA approval of Solosec was supported by a comprehensive set of studies, including two pivotal trials in BV and an open label safety study, which found efficacy for single-dose secnidazole 2g. Across both studies, Solosec was generally well tolerated with a low incidence of side effects.  ]]> <![CDATA[Lupin appoints Nicholas Hart as head of specialty biz in US]]> https://biospectrumindia.com/news/95/11052/lupin-appoints-nicholas-hart-as-head-of-specialty-biz-in-us.html https://biospectrumindia.com/news/95/11052/lupin-appoints-nicholas-hart-as-head-of-specialty-biz-in-us.html Fri, 01 Jun 2018 13:25:00 +0530 Drug maker Lupin has appointed Nicholas Hart as President of its Specialty business in US. Hart will lead the specialty strategic business unit in the US and will be responsible for its business growth strategy and organisation. Most recently, Hart was the Business Unit Head for Reproductive Health at Ferring Pharmaceuticals, Inc. Prior to Ferring, he served as Senior Vice President of Sales and Marketing at URL Pharma.  "We are delighted to welcome Nick to Lupin at a crucial time as we prepare to launch Solosec in the US market and accelerate efforts to build our Specialty business,"  Lupin CEO Vinita Gupta said . His knowledge and experience in the industry will be valuable for company's growth aspirations in the US market, she added. Hart will be based in Baltimore, Maryland in the US, and will report to Gupta. ]]> <![CDATA[Pfizer's Xalkori receives FDA breakthrough therapy designation ]]> https://biospectrumindia.com/news/95/11041/pfizers-xalkori-receives-fda-breakthrough-therapy-designation-.html https://biospectrumindia.com/news/95/11041/pfizers-xalkori-receives-fda-breakthrough-therapy-designation-.html Thu, 31 May 2018 12:30:00 +0530 Pfizer Inc. has announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for XALKORI (crizotinib) for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with MET exon 14 alterations with disease progression on or after platinum-based chemotherapy. The FDA also granted Breakthrough Therapy designation for XALKORI for the treatment of patients with relapsed or refractory systemic anaplastic large cell lymphoma (ALCL) that is anaplastic lymphoma kinase (ALK)-positive. MET is a trans membrane tyrosine receptor kinase which is expressed in several types of cells. In patients with NSCLC, MET exon 14 alterations occur in approximately three percent of NSCLC tumors. Anaplastic large cell lymphoma is a rare type of non-Hodgkin lymphoma, divided into ALK-positive or ALK-negative disease. Despite the activity of chemotherapy, many patients with ALCL relapse or require alternative treatment approaches. “Biomarker-driven therapies have changed the way we treat cancer, helping to ensure that patients receive the right medicine for their disease,” said Mace Rothenberg, M.D., chief development officer, Oncology, Pfizer Global Product Development. “These Breakthrough Therapy designations for XALKORI exemplify our commitment to precision medicine development and delivering medicines that have the potential to transform the lives of patients whose cancers carry these genomic alterations.” XALKORI is currently approved in the U.S. for the treatment of patients with metastatic NSCLC whose tumors are ALK-positive or ROS1-positive as detected by an FDA-approved test. XALKORI became a first-line standard of care for ALK-positive metastatic NSCLC in its first approved indication and has proven to be a practice-changing treatment for patients with ALK-positive and ROS1-positive NSCLC, globally. It is the only FDA-approved treatment indicated for both ALK-positive and ROS1-positive metastatic NSCLC. If approved in patients with metastatic NSCLC with MET exon 14 alterations, XALKORI will be the only TKI with demonstrated efficacy in three separate biomarker-driven indications in NSCLC. The Breakthrough Therapy designation for patients with metastatic NSCLC with MET exon 14 alterations was supported by results from an expansion cohort of the Phase 1 PROFILE 1001 study, in which XALKORI showed antitumor activity.  The designation for patients with relapsed or refractory systemic ALCL that is ALK-positive was supported by the results from Study ADVL0912 (NCT00939770) and Study A8081013 (NCT01121588). Study ADVL0912 is a Phase 1/2 study conducted by the Children’s Oncology Group evaluating the maximum dose that is safe and tolerable, and assessing preliminary clinical activity in pediatric patients with relapsed or refractory solid tumors and ALCL. Study A8081013 evaluated XALKORI in pediatric and adult patients with advanced malignancies known to be ALK-positive other than NSCLC and included patients with relapsed/refractory ALCL. These two studies showed compelling antitumor activity in pediatric and adult patients who received XALKORI. The FDA’s Breakthrough Therapy designation is intended to expedite the development and review of a medicine if it is intended to treat a serious or life-threatening disease and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies. The Breakthrough Therapy designation is distinct from the FDA’s other mechanisms to expedite drug development and review.   ]]> <![CDATA[Granules Pharma launches generic Methylergonovine tablets]]> https://biospectrumindia.com/news/95/11037/granules-pharma-launches-generic-methylergonovine-tablets.html https://biospectrumindia.com/news/95/11037/granules-pharma-launches-generic-methylergonovine-tablets.html Thu, 31 May 2018 10:30:00 +0530 Granules Pharmaceuticals, Inc., the wholly owned subsidiary of Granules India Ltd., has launched the generic version of Methylergonovine Maleate Tablets, USP, 0.2mg, the generic equivalent to Methergine in partnership with West-Ward Pharmaceuticals Corp. (West-Ward), a wholly-owned subsidiary of Hikma Pharmaceuticals PLC (Hikma). Methylergonovine is a semi-synthetic ergot alkaloid used for the prevention and control of postpartum haemorrhage. “This is the first product we have commercialized from our R&D and manufacturing facility in Virginia and we are happy to have collaborated with Hikma . Apart from the fact that Hikma has a proven history of being a responsible player in the market, we look at this launch as the inception towards building a strategic relationship.The launch of generic Methergine tablets playsinto our strategy of identifying patient needs and catering to them with economical alternatives.” said Ms. Priyanka Chigurupati, Executive Director, Granules Pharmaceuticals, Inc. Brian Hoffmann, President of West-Ward,said, “We are very pleased to be entering into a partnership with Granules Pharmaceuticals, Inc., adding this important oxytocic agent to our product portfolio in the US. This partnership demonstrates our focus on improving patient’s access to high-quality, affordable medicines.” ]]> <![CDATA[AstraZeneca expands Global Medicines Development centre in India]]> https://biospectrumindia.com/news/95/11035/astrazeneca-expands-global-medicines-development-centre-in-india.html https://biospectrumindia.com/news/95/11035/astrazeneca-expands-global-medicines-development-centre-in-india.html Wed, 30 May 2018 16:30:00 +0530 Global science-led biopharmaceutical company AstraZeneca officially opened its new Global Medicines Development (GMD) Centre in Bengaluru, India today. This unit is one of AstraZeneca’s nine GMD centres around the world that transform breakthrough molecules into medicines and monitor their use and safety. With this opening, India will now play an even bigger role in AstraZeneca’s global operations. Globally, GMD works with AstraZeneca’s two biotech units – Innovative Medicines and Early Development (IMED) and MedImmune – and the Global Portfolio and Product Strategy (GPPS) organisation to understand where there is unmet medical need, to shape AstraZeneca’s therapy area strategies from early development through to commercialisation. The GMD Bengaluru team will focus on supporting AstraZeneca’s medicines, which covers treatments across a range of therapy areas, including oncology, respiratory and cardiovascular and metabolic diseases. GMD Bengaluru plays a key role supporting 51 of AstraZeneca’s mature brands which are used by patients around the world. During the last year, the team has recruited scientific experts in the fields of regulatory science, clinical, and patient safety, and has grown from 30 to 70 people. The expansion will see a further increase to more than 100 specialists. His Excellency Klas Molin, Swedish Ambassador to India and Chief Guest for the inauguration stated, “Further to the bilateral innovation partnership between India and Sweden, we are pleased to bring more Swedish innovation into the country. The opening of AstraZeneca GMD unit in India is yet another promising step for strengthening this partnership for a sustainable future between Sweden and India.” Ms. Elisabeth Björk VP, Global Medicines Development Unit Head for Cardiovascular, Metabolic Renal Diseases, AstraZeneca present at the inauguration of the new GMD office space in Bengaluru said, “AstraZeneca has a long-standing commitment in India over 40 years. The GMD expansion is part of AstraZeneca’s continued commitment to enhance scientific innovation in the country and I am delighted to open our newest GMD site and to welcome our new colleagues to the AstraZeneca team". Ms. Veena Rajan, GMD Site Lead Bengaluru, AstraZeneca India Private Limited stated, “We plan to recruit more physicians, scientists and regulatory experts to support the GMD Bengaluru, and continue to deliver value for our global mature brands in oncology, respiratory, cardiovascular and metabolic diseases.” Mr. Siva Padmanabhan, Centre Head, Global Technology Centre Chennai, AstraZeneca India Private Limited said, “The GMD expansion further strengthens AstraZeneca’s commitment to invest in scientific capabilities to deliver more effective medicines to help meet unmet treatment needs for patients around the world.” ]]> <![CDATA[Sanofi Genzyme partners with MSSI]]> https://biospectrumindia.com/news/95/11031/sanofi-genzyme-partners-with-mssi.html https://biospectrumindia.com/news/95/11031/sanofi-genzyme-partners-with-mssi.html Wed, 30 May 2018 13:05:00 +0530 Sanofi Genzyme, the specialty care global business unit of Sanofi, and Multiple Sclerosis Society of India (MSSI) join hands to raise awareness and to provide better treatment solutions for the 130,000 people living with Multiple Sclerosis (MS) in India. Sanofi Genzyme and MSSI are working together to ensure that people affected with multiple sclerosis can continue to live fuller lives through support programs that enhance their quality of life. The eight MSSI chapters in - Delhi, Mumbai, Bengaluru, Chennai, Hyderabad, Kolkata, Indore and Pune, along with Sanofi Genzyme are rolling out this year’s campaign #bringinguscloser, through various awareness programs such as symposiums, MS camps, MS walks, medical seminars, photo exhibitions, and laughter & music therapy sessions. These programs will help bring the multiple sclerosis (MS) community together to share stories and raise awareness about the condition. Sanofi Genzyme in India is focused on treatment for multiple sclerosis, rare diseases, and immunology. Through its partnership with the MSSI in India, Sanofi Genzyme is playing a critical role in enabling and empowering the lives of people with multiple sclerosis. Globally, Sanofi Genzyme is continuously working to advance multiple sclerosis treatment and care with therapies, portfolio of research and development-stage programs, and MS research collaborations. N. Rajaram, Managing Director, Sanofi India, said, “At Sanofi, one of our priorities is to empower people with multiple sclerosis and improve their quality of life. Sanofi Genzyme is proud to support initiatives, including educational projects, and provide information and resources to raise awareness of multiple sclerosis in India. In line with that objective, we are in the process of introducing new and effective treatment options in India that would help in the management of this debilitating disease.” Viresh Oberoi, Honorary President, Multiple Sclerosis Society of India (MSSI) said, “During the month of May, every year, around the World, an added focus is brought to spread solidarity amongst our Members (those afflicted with multiple sclerosis, their care givers and family members, doctors, nurses, well-wishers) and, to reach out to those who are not currently our Members to share with them how we can help them cope with this affliction. Even today we do not know with certainty what causes multiple sclerosis and how we can eliminate it. The theme of this year’s ‘celebration’ of World MS Day is ‘Bringing us closer - An objective, which I am sure which will make us all stronger and will provide hope for the future.” Dr. P. Satishchandra, Senior Professor, Department of Neurology, Apollo Hospital & Former Director & Vice Chancellor National Institute of Mental Health & Neuro Sciences (NIMHANS), said, “Today, with the advancement of technologies, we are better equipped to diagnose more cases of multiple sclerosis. Most people with MS have what is known as ‘relapsing-remitting MS’ where the relapse can be prevented with the use of appropriate disease modifying therapies. As a neurologist who treats many patients with MS, I wish to urge everyone to be more aware of the symptoms of this condition because an early diagnosis and appropriate treatment can ensure a healthier life.” About Multiple Sclerosis (MS) Multiple Sclerosis is an autoimmune, debilitating disease of the nervous system that affects the spinal cord and brain. In multiple sclerosis, there is progressive damage to the sheath that protects nerve cells, impairing communication between the brain and the nervous system. Signs and symptoms vary from one person to another and may include: weakness and numbness in the limbs, poor vision, tingling and pain in parts of the body, unsteady gait, lack of coordination, fatigue or slurred speech. Multiple sclerosis can be difficult to diagnose and requires lifelong management. About World MS Day  A day to commemorate global solidarity and hope for the future, World MS Day is officially marked on the last Wednesday of May, each year. Events and campaigns are organized throughout the month of May. It brings the global MS community together to share real life stories, raise awareness and campaign with and for everyone affected by multiple sclerosis. The 2018 campaign is called and the theme is ‘research’. In 2009, the MS International Federation (MSIF) and its members initiated the first World MS Day. ]]> <![CDATA[Himalaya BabyCare honours nurses across India]]> https://biospectrumindia.com/news/95/11028/himalaya-babycare-honours-nurses-across-india.html https://biospectrumindia.com/news/95/11028/himalaya-babycare-honours-nurses-across-india.html Tue, 29 May 2018 18:15:00 +0530 Himalaya BabyCare, India’s leading homegrown baby care brand, recognized and felicitated over 80 nurses across various government and private hospitals at Mumbai. A flagship initiative by Himalaya BabyCare, this initiative aims at celebrating the work done by health care practitioners who have completed 25 years and above in the field.   The guests of honor at the event were Dr. Neha Pawar and Dr. Sushanta Pai who also felicitated the nurses. The initiative aims to honor nurses for their selfless contribution towards establishing and implementing nursing care with compassion. Himalaya BabyCare will be honouring nurses across major cities in the country like Pune, New Delhi, Agra, Varanasi, Lucknow, Ghaziabad, Ambala, Jalandhar, Surat and Nagpur with gifts and certificates.   Speaking about the initiative, Mr. Chakravarthi, Business Head Himalaya BabyCare, said “Nurses play a significant role in patient care and safety. They are filled with compassion and treat each patient with the same compassion and care. They work around the clock to provide the patient the best care. This goes a long way in healing patients, both physically and emotionally. Through this initiative, we extend our gratitude to all the nurses across the globe for their selfless contribution.”   Himalaya BabyCare celebrates the nursing profession and the role that a nurse plays in the health of a patient and understands the selfless dedication and support that has helped improve the quality of many lives.   “We truly value and respect the efforts made by the nurses to ensure patient safety and care. They are an important resource to the healthcare organization and are the primary care giver in the hospitals for holistic health supervision. I would like to thank Himalaya for recognizing nurses efforts in patient care,” says Dr. Neha Pawar. ]]> <![CDATA[Strides Shasun needs shareholders' nod to change its name ]]> https://biospectrumindia.com/news/95/11024/strides-shasun-needs-shareholders-nod-to-change-its-name-.html https://biospectrumindia.com/news/95/11024/strides-shasun-needs-shareholders-nod-to-change-its-name-.html Tue, 29 May 2018 12:45:00 +0530 Drug firm Strides Shasun has sought shareholders' nod to change its name to Strides Pharma Science.   This is the second time in three years when the name of the company will change.   In November 2015, Strides Arcolab had changed its name to Strides Shasun post amalgamation of Shasun Pharmaceuticals with Strides Arcolab.   "Approval of the members is sought by way of a special resolution for the proposed name change of the company from Strides Shasun to Strides Pharma Science," Strides Shasun said in a postal ballot notice seeking approval of shareholders.   "Consequent to the demerger of the company from its Commodity API business to Solara, it is proposed to change the name of the company from," it added.   ]]> <![CDATA[Ajanta, Aurobindo, Sun Pharma gets tentative FDA approval of Tadalafil ]]> https://biospectrumindia.com/news/95/11007/ajanta-aurobindo-sun-pharma-gets-tentative-fda-approval-of-tadalafil-.html https://biospectrumindia.com/news/95/11007/ajanta-aurobindo-sun-pharma-gets-tentative-fda-approval-of-tadalafil-.html Thu, 24 May 2018 13:20:00 +0530 Tadalafil, an oral drug that is used for treating impotence, has seen the first wave of approvals and Indian companies - Ajanta, Aurobindo and Sun Pharma, all have seen tentative approvals in this. Tadalafil is manufactured by Eli Lilly and it is sold under two brands as Cialis and Adcirca. Adcirca and Cialis will lose their first patent in 2018 and last patent in 2021. Cialis also has pediatric exclusivity which will expire in 2021. Cialis reported annual sales of $2.3bn and Adcirca reported sales of $290mn in 2017. Teva has received final approval in the first wave. ]]> <![CDATA[Qure.ai partners with TRS and Telerad Tech to enable better patient care]]> https://biospectrumindia.com/news/95/11005/qure-ai-partners-with-trs-and-telerad-tech-to-enable-better-patient-care.html https://biospectrumindia.com/news/95/11005/qure-ai-partners-with-trs-and-telerad-tech-to-enable-better-patient-care.html Thu, 24 May 2018 11:20:00 +0530 Qure.ai, a healthcare AI provider has announced that it has partnered with Teleradiology Solutions (TRS), a global pioneer in remote radiology interpretation and telehealth, and Telerad Tech (T2), a global health IT company and AI-enabled RIS-PACS provider, to enable smarter and faster diagnoses of X-ray and CT-scan data, and reduce costs.  Through this partnership, Qure.ai’s chest X-ray technology will be integrated with Telerad Tech’s proprietary RIS PACS platform – RADSpa that TRS uses to provide teleradiology services globally. “At Qure.ai, we are expanding the reach of our AI algorithms to help medical professionals deliver better outcomes to their patients,” said Prashant Warier, Co-Founder and CEO, Qure.ai. “TRS and Telerad Tech are pioneers in their respective domains, and we are excited about the impact this partnership will have on the millions of patients’ lives they touch.”  TRS has reported scans for over five million patients since inception in 2002, and currently caters to the requirements of 150 hospitals and healthcare centers in more than 20 countries, including the United States, Singapore, Nigeria, Tanzania, Uganda, Maldives and India.  Telerad Tech’s RADSpa platform is deployed in 24 countries and has processed more than 20 million studies and billions of images. RADSpa is FDA approved and CE certified.  TRS’s clinical expertise and Telerad Tech’s RADSpa platform consolidates radiology report information from diverse sources so radiologists can review these reports from anywhere and anytime. By integrating Qure.ai’s algorithms that automatically generate abnormality reports from X-rays and CT scans, radiologists and hospitals using RADspa will now have cutting-edge algorithms at their disposal to help prioritize care, make smarter and faster diagnoses, and reduce costs. This integration is expected to go-live in the next four months in several Indian states where TRS provides teleradiology services.  “Making sure that doctors and hospitals have the necessary and highest quality information has to be the topmost priority,” said Dr Arjun Kalyanpur, CEO Teleradiology Solutions. “Diseases that are of public health importance worldwide such as tuberculosis, are within our focus of interest with a goal of providing high quality diagnostics to facilitate early detection. Qure.ai, TRS & T2 have a shared vision when it comes to achieving this goal, and we strongly believe this will be highly beneficial for doctors, hospitals and patients alike”.  Qure.ai’s chest X-ray solution can automatically screen for abnormal chest X-rays and tuberculosis. Qure.ai’s automated reads can have a substantial impact on the screening protocol for tuberculosis globally.  “Qure.ai’s chest X-ray solution helps in early identification of probable TB cases and helps doctors in fast-tracking of TB patients for confirmatory diagnosis. It will act as a force multiplier for early and fast detection” says Dr. Shibu Vijayan, Director at PATH India, an NGO that has been working to improve TB outcomes in India for years.  Founded in 2016, Qure.ai is funded by Fractal Analytics, a global leader in artificial intelligence and analytics that powers decision-making in Fortune 500 companies. ]]> <![CDATA[Sun Pharma announces USFDA approval for YONSA ]]> https://biospectrumindia.com/news/95/10997/sun-pharma-announces-usfda-approval-for-yonsa-.html https://biospectrumindia.com/news/95/10997/sun-pharma-announces-usfda-approval-for-yonsa-.html Wed, 23 May 2018 13:55:00 +0530 Sun Pharmaceutical Industries has announced that one of Sun Pharma’s wholly owned subsidiary companies has received approval from the U.S. Food and Drug Administration for YONSA, a novel formulation in combination with methylprednisolone, for the treatment of patients with metastatic castration-resistant prostate cancer. Churchill is eligible to receive upfront and sales-linked milestone payments, and royalties on sales from Sun Pharma pursuant to an agreement between the two companies to commercialize YONSA in the U.S. Churchill Pharmaceuticals is focused on providing value to cancer care by developing quality orally delivered oncology products with optimized clinical profiles. Churchill has a license from iCeutica to the SoluMatrix Fine Particle Technology, a proprietary manufacturing process that may unlock the potential of certain oral drugs by changing how well they dissolve and how efficiently they are absorbed. “We are pleased to add YONSA to our growing oncology portfolio and continue to deliver on Sun Pharma’s commitment for enhanced patient access to innovative cancer therapies,” said Abhay Gandhi, CEO - North America, Sun Pharma.  YONSA in combination with methylprednisolone was filed as a New Drug Application (NDA) under the 505(b)(2) regulatory pathway and will be promoted as a branded product in the U.S.   ]]> <![CDATA[Glenmark Pharma submits First New Drug Application for Ryaltris]]> https://biospectrumindia.com/news/95/10996/glenmark-pharma-submits-first-new-drug-application-for-ryaltris.html https://biospectrumindia.com/news/95/10996/glenmark-pharma-submits-first-new-drug-application-for-ryaltris.html Wed, 23 May 2018 13:30:00 +0530 Glenmark Pharmaceuticals, a global pharmaceutical company announced that the company has submitted a New Drug Application (NDA) to the U.S. Food & Drug Administration (FDA) for its leading respiratory pipeline candidate Ryaltris™ (rye - al' - tris), an investigational fixed-dose combination nasal spray of an antihistamine and a steroid, as a treatment for seasonal allergic rhinitis (SAR) in patients 12 years of age and older. Ryaltris (olopatadine hydrochloride (665 mcg) and mometasone furoate (25 mcg)), formerly GSP 301 Nasal Spray, has been conditionally accepted by the FDA as the brand name. Glenmark expects the FDA will determine whether the NDA is complete for filing within 60 days. If the NDA is accepted, the Prescription Drug User Fee Act (PDUFA) target action date will be assigned at that time. Glenmark has studied Ryaltris in seven clinical trials involving more than 4,000 patients. Phase 3 results of Ryaltris have been previously presented at key medical meetings, most recently at the Joint Congress of the American Academy of Allergy, Asthma and Immunology and the World Allergy Organization held in March 2018. ]]> <![CDATA[Pharma Packaging Market to face significant growth]]> https://biospectrumindia.com/news/95/10991/pharma-packaging-market-to-face-significant-growth.html https://biospectrumindia.com/news/95/10991/pharma-packaging-market-to-face-significant-growth.html Tue, 22 May 2018 17:45:00 +0530 Packaging is greatest industry sections in the world of value in several billion. Pharmaceutical packaging signifies a small percentage of this immense market. The worldwide healthcare market has seen a change in an idea and is now tilted towards effectual and meaningful packaging. The global Pharmaceutical Packaging Market is expected to witness a significant growth owing to the requirement for pharmaceutical packaging is growing and will carry on to increase as companies depend more on labelling and packaging as media to defend and promote their goods, boost patient compliance coupled with a need to meet novel regulations. The pharmaceutical package ought to ensure sufficient stability of the product throughout its life. Pharmaceutical packaging fundamentally classified into three types primary, tertiary and secondary. Initial pharmaceutical packaging products such as blister packs, plastic bottles, caps & closures, ampoules & vials, and so on govern the pharmaceutical packaging market and will be increasing at a healthy rate over the forecast period. Within the most important packaging products, inhalers, pre-fillable syringes and other innovative and advanced products are expected to drive the future growth in the pharmaceutical packaging industry over the forecast period. The increasing requirement for drug delivery equipment is a big enhancement for the packing companies as it demands high-quality basis and provides high profitability for the provider. Oral drugs, injectable, Transdermal and pulmonary are the rapidly growing sections in the drug deliverance business globally. The global pharmaceutical packaging industry is expected to see major push owing to a ceaselessly growing requirement of biologics. Advancements in biotechnology often direct to the introduction of novel therapies that have to be injected. The rapid growth in the pharmaceutical packaging market is expected to approach parenteral vials, which will carry on expanding as advancement in biotechnology direct to the introduction of novel therapies that must be injected. The growing demand for biologics will reinforce demand for pioneering product packaging system in the worldwide pharma packaging market. All these regions, coupled with the increasing pharma industry, will carry on driving a requirement for packaging over the forecast period. Moreover, the packaging market will have to conquer challenges, such as the accessibility and price instability of raw materials and altering health regulations, in order to congregate growing demand from the increasing pharma industry. The fast growing demand for pre-fillable syringes is the main augmentation driver for this market over the forecast period. These syringes provide numerous advantages such as reduction of drug waste, growing usefulness product life, and handiness in drug administration and are incorporated by advanced deliverance systems such as auto-injectors and pens. Glass is the mainly popular packaging substance for these injections with the great demand. The market is expected to get benefit from technical advancements such as the beginning of nano able packaging, this packaging type that presently offers the most superior barrier properties in opposition to light, moisture and mechanical forces. On the basis of products, the pharmaceutical packaging market can be segregated into closures, blister packaging, parenteral packaging, plastic bottles, other primary packaging and others. Parenteral containers are expected to capture maximum revenue over the forecast period owing to its increasing demand in health care industry coupled with the initiation of better-injected therapies across the world. Blister Packaging is expected to grow rapidly over the forecast period owing to its increasing demand. On the basis of the geographical region, the market can be segregated into North America, Europe, Asia Pacific and Rest of world. North America and Europe is expected to cover maximum profit over the forecast period owing to increasing pharma industry in this area. Europe is also expected to capture considerable profit over the forecast period owing to latest technological advancements that are happening in this part of the world. ]]> <![CDATA[Suven Life procures patents from New Zealand and Norway]]> https://biospectrumindia.com/news/95/10989/suven-life-procures-patents-from-new-zealand-and-norway.html https://biospectrumindia.com/news/95/10989/suven-life-procures-patents-from-new-zealand-and-norway.html Tue, 22 May 2018 15:10:00 +0530 Suven Life Sciences has been granted a product patent by New Zealand and Norway each corresponding to a new chemical entity (NCE) for treatment of disorders associated with neurodegenerative diseases. These patents are valid till 2034 and 2027, respectively, the company said in a BSE filing. "We are pleased by the grant of these patents to Suven for our pipeline of molecules in the CNS arena, which are being developed for cognitive disorders with high unmet medical need with a huge market potential globally," Suven Life CEO Venkat Jasti said. The granted claims of patents are being developed as therapeutic agents useful in treatment of cognitive impairment associated with neurodegenerative disorders like Alzheimer's disease, attention deficient hyperactivity disorder (ADHD), Huntington's disease, Parkinson's and schizophrenia, it added. ]]> <![CDATA[Stempeutics inks a deal with Cipla for Stempeucel]]> https://biospectrumindia.com/news/95/10974/stempeutics-inks-a-deal-with-cipla-for-stempeucel.html https://biospectrumindia.com/news/95/10974/stempeutics-inks-a-deal-with-cipla-for-stempeucel.html Fri, 18 May 2018 16:00:00 +0530 Biotech firm Stempeutics Research has said that it has inked an out-licensing deal with drug major Cipla for its stem cell therapy product Stempeucel, indicated for treating critical limb ischemia.  "Under this agreement, Cipla will get exclusive marketing rights for five years in India for critical limb ischemia due to atherosclerotic peripheral arterial disease (CLI-PAD) with Stempeutics manufacturing and supplying the product to Cipla," the company said in a statement.    CLI-PAD is characterised by narrowing of arteries in the legs limiting blood flow to the muscles due to the build-up of fatty deposits called plaque, Stempeutics said.  "The product is expected to be available in the Indian market in the beginning of 2020 after undergoing the phase 3 clinical trial in India, which is expected to commence in 2018," it added.  Stempeutics CEO BN Manohar said, "Although alternate treatments exist for CLI-PAD, only 50 per cent of patients can be  managed with contemporary vascular techniques, while satisfactory clinical outcomes are evident in about 25 per cent of the patients," Manohar said.  Stempeucel has significant potential to overcome limitations of traditional treatment approaches for CLI due to anti-inflammatory properties, ability to promote neovascularization and promote healing of non-healing ischemic ulcers, he added.    ]]> <![CDATA[Jubilant Life gets USFDA nod for Niacin tablets]]> https://biospectrumindia.com/news/95/10955/jubilant-life-gets-usfda-nod-for-niacin-tablets.html https://biospectrumindia.com/news/95/10955/jubilant-life-gets-usfda-nod-for-niacin-tablets.html Wed, 16 May 2018 17:50:00 +0530 Jubilant Life Sciences Ltd recently announced that it has received the final approval from USFDA for its generic Niacin extended-release tablets used for controlling cholesterol levels. According to the company statement, “The approval granted by the US Food and Drug Administration (USFDA) to the company's wholly-owned arm Jubilant Pharma Ltd, is for multiple strengths of Niacin extended-release tablets of 500 mg, 750 mg, and 1,000 mg.” These are the generic equivalent of AbbVie's Niaspan, which is indicated to reduce elevated high-density lipoprotein among others while increasing HDL-C (good cholesterol) in patients with primary hyperlipidemia and mixed dyslipidemia. “The drug helps reduce the risk of recurrent nonfatal myocardial infarction (heart attack) in patients with a history heart disease and hyperlipidemia. This is the first approval that we have received from the USFDA during the current financial year”, the statement added. ]]> <![CDATA[Glenmark Pharma launches generic Seretide Accuhaler to treat asthma]]> https://biospectrumindia.com/news/95/10952/glenmark-pharma-launches-generic-seretide-accuhaler-to-treat-asthma.html https://biospectrumindia.com/news/95/10952/glenmark-pharma-launches-generic-seretide-accuhaler-to-treat-asthma.html Wed, 16 May 2018 13:20:00 +0530 Glenmark Pharmaceuticals Europe Ltd has launched a generic version of Seretide Accuhaler, used to treat asthma, in Denmark. The product was developed by Celon Pharma and Glenmark has marketing and distribution rights for the product across 15 European countries. "This is Glenmark's first inhaled respiratory product launch in Europe. Glenmark is the first generic company to receive regulatory approval for substitution in Denmark for its generic of Seretide Accuhaler," said Glenmark Pharmaceuticals Ltd. Glenmark had entered into a strategic development and licensing agreement with Celon Pharma S.A. to develop and market a generic version of GlaxoSmithKline's Seretide Accuhaler product - Fluticasone/Salmeterol dry powder inhaler in 15 European countries. Fluticasone/Salmeterol dry powder inhaler is a combination product for the treatment of asthma and chronic obstructive pulmonary disease (COPD), it added. Glenmark said it has already received National Marketing Authorizations for the product in Sweden, Finland, Norway and Iceland. Quotng IQVIA data, Glenmark Pharma said Fluticasone/Salmeterol dry powder Inhaler (DPI) had sales of USD 864 million in Europe in the 12 month period ending September 2017. ]]> <![CDATA[Agilent completes acquisition of Genohm]]> https://biospectrumindia.com/news/95/10946/agilent-completes-acquisition-of-genohm.html https://biospectrumindia.com/news/95/10946/agilent-completes-acquisition-of-genohm.html Tue, 15 May 2018 17:15:00 +0530 Agilent Technologies, Inc. has completed the acquisition of Lausanne, Switzerland-based Genohm, a developer of highly differentiated, on-premise and cloud-based software solutions for laboratory management. Genohm’s main laboratory software automation suite, SLIMS, is a digital platform that provides laboratories with a rapidly deployable and seamless laboratory information management system (LIMS) and electronic lab notebook (ELN) environment that is used in biobanks, research labs and next generation sequencing facilities. This acquisition enhances Agilent’s current software portfolio, adding LIMS and workflow management, while expanding ELN capability. This combination will allow Agilent to bring greater context to analytical data, enabling scientists to generate results more efficiently. “We are pleased to complete our acquisition of Genohm,” said John Sadler, Vice President and General Manager of Agilent’s Software and Informatics Division. “Agilent and Genohm are both focused on customer-centric innovation and committed to helping our customers do more with their data. The addition of Genohm’s SLIMS platform is an outstanding strategic fit with our company, and together we look forward to accelerating development of the digital lab.” Financial terms are not being disclosed ]]> <![CDATA[Aurobindo Pharma's arm voluntarily recalls two antibiotic injections]]> https://biospectrumindia.com/news/95/10940/aurobindo-pharmas-arm-voluntarily-recalls-two-antibiotic-injections.html https://biospectrumindia.com/news/95/10940/aurobindo-pharmas-arm-voluntarily-recalls-two-antibiotic-injections.html Tue, 15 May 2018 12:15:00 +0530 AuroMedics Pharma LLC, a US subsidiary of Aurobindo Pharma Ltd has initiated voluntary recall of two lots each of two injections from the US market following customer complaints about presence of particles in the vial.  The fresh recall follows a recent withdrawal of over 1.5 million injections by the company due to “Lack of Assurance of Sterility.” According to a letter issued to the US Food and Drug Administration department, the recall of Ampicillin and Sulbactam for injection, USP, Single-Dose vial, to the hospital has been initiated due to customer complaints of the presence of red particulate matter in the product.  Two lots of Piperacillin and Tazobactam for injection, USP 3.375 g (Piperacillin Sodium equivalent to 3 g of Piperacillin USP and Tazobactam Sodium equivalent to 0.375 g of Tazobactam USP are being recalled. Each vial contains 7.05 mEq (162 mg) of Sodium) in a Single-Dose vial, to the hospital level. The products have been found to contain particulate matter, visible only after reconstitution that was confirmed to be glass within the vial. The administration of a glass particulate, if present in an intravenous drug, may result in local irritation or swelling in response to the foreign material. More serious potential outcomes would include blockage and clotting in blood vessels, which may be life-threatening. To date, AuroMedics Pharma LLC has not received reports of any adverse events or identifiable safety concerns attributed to the product consumed from these lots. “Piperacillin and Tazobactam for Injection is used for treatment of patients with moderate to severe infections caused by susceptible isolates of the designated bacteria in intra-abdominal, skin and skin structure and female pelvic infections as well as community acquired and nosocomial pneumonia,” said a statement.  It is packaged in a carton containing 10 single- dose vials. “The product can be identified as a clear vial stoppered with grey rubber stopper and sealed with aluminum seals having a Royal Blue color polypropylene disc,” a statement issued by FDA stated further. ]]> <![CDATA[Lupin launches Corcal Bone and Beauty supplement]]> https://biospectrumindia.com/news/95/10935/lupin-launches-corcal-bone-and-beauty-supplement.html https://biospectrumindia.com/news/95/10935/lupin-launches-corcal-bone-and-beauty-supplement.html Mon, 14 May 2018 12:25:00 +0530 Pharma major Lupin, under its consumer healthcare division – LupinLife announced the launch of Corcal Bone and Beauty, a novel calcium health supplement for women. Made from 100% natural coral grains sourced from Okinawa, Japan, Corcal Bone and Beauty contains natural Coral Calcium and over 70 trace minerals like Zinc, Selenium, Gold, Magnesium, and Silica. Corcal helps strengthen bones and maintain healthy hair, skin, nails and teeth. Speaking on the matter, Nilesh Gupta – Managing Director, Lupin said, “The steady growth of the Indian OTC segment presents Lupin with an ideal opportunity to expand its product portfolio. Women’s health is a key focus area for us and nutrition-linked conditions are widely prevalent amongst women in India. We are very excited with the launch of Corcal Bone and Beauty, a unique health supplement to address the needs of progressive and modern women.” Most medical practitioners believe that calcium deficiency is an important reason for poor bone health. As per the International Osteoporosis foundation, more than 30% of women are at risk of bone fracture. Moreover, there is a gradual erosion of good health affecting appearance of teeth, hair, skin and nails amongst women. This condition gets pronounced particularly post pregnancy up to and beyond menopause. Anil V Kaushal – Head of LupinLife, Consumer Healthcare Division of Lupin said, “Women’s health is a topic that has been neglected in India. With demanding and multifaceted roles, as a homemaker, a professional and also a mother, women lead challenging lifestyles. Due to this, they often ignore their own health and avoid the care they deserve. During interactions with women across the country, our key insight was that women believe the key to lasting beauty is maintaining their inner health. Corcal Bone and Beauty is a unique Calcium health supplement that meets the growing needs of women to maintain their inner health and beauty. We are excited about expanding our portfolio and contributing towards the untapped health needs of our consumers.” The Indian OTC market is estimated to be worth INR 18,862 crores in 2016 (Nicholas Hall’s global OTC sales database DB6 ) and is expected to grow at a CAGR of 9% to a size of approximately INR 44,100 crores by 2026. The Vitamins, Minerals and Supplements category is the largest in the OTC space, constituting 28% as per Nicholas Hall’s global OTC sales database DB6. With the launch of Corcal Bone and Beauty, Lupin Life aims to develop the nascent Women’s Health segment within the Vitamins, Mineral and Supplements space. Corcal Bone and Beauty is available in packs of 10 easy-to-consume mini-tablets, and comes with a serving suggestion of one to two tablets with a glass of water. It is available at leading pharmacy stores across India, in addition to online e-commerce sites.   ]]> <![CDATA[Lupin's Nagpur facility US FDA inspection concluded with no observations]]> https://biospectrumindia.com/news/95/10934/lupins-nagpur-facility-us-fda-inspection-concluded-with-no-observations.html https://biospectrumindia.com/news/95/10934/lupins-nagpur-facility-us-fda-inspection-concluded-with-no-observations.html Mon, 14 May 2018 12:20:00 +0530 Pharma major Lupin has announced the successful completion of an inspection carried out by the US FDA at its Nagpur facility. The inspection concluded without any observations. Lupin’s Nagpur facility is the company’s latest facility and manufactures oral solid products. Currently, Lupin is the 11th and 7th largest generics pharmaceutical company by market capitalization The Company is the 4th largest pharmaceutical player in the US by prescriptions; 2nd largest Indian pharmaceutical company by global revenues; 6th largest generic pharmaceutical player in Japan and 5th largest company in Indian Pharmaceutical Market . For the financial year ended 31st March, 2017, Lupin’s consolidated sales and Net profit stood at Rs. 171,198 million (USD 2.55 billion) and Rs. 25,575 million (USD 381 million) respectively. ]]> <![CDATA[Glenmark Pharma gets USFDA nod for skin treatment cream]]> https://biospectrumindia.com/news/95/10930/glenmark-pharma-gets-usfda-nod-for-skin-treatment-cream.html https://biospectrumindia.com/news/95/10930/glenmark-pharma-gets-usfda-nod-for-skin-treatment-cream.html Mon, 14 May 2018 11:45:00 +0530 Glenmark Pharmaceuticals has received final approval from the USFDA for the generic version of Temovate cream used to treat inflammation and itching. “Glenmark Pharmaceuticals Inc., USA has been granted final approval by the USFDA for Clobetasol Propionate cream USP, 0.05%, the generic version of Temovate Cream, 0.05%, of Fougera Pharmaceuticals, the firm said in a BSE filing. Citing IQVIA sales data, Glenmark said that the company achieved annual sales of approximately $118 million from Temovate cream. The company’s current portfolio consists of 134 products authorised for distribution in the US marketplace and 61 abbreviated new drug applications (ANDA) pending approval with the USFDA. Glenmark shares were trading 1.75 per cent lower at Rs 507 on the BSE. ]]> <![CDATA[USFDA completes inspection of Lupin's Nagpur plant]]> https://biospectrumindia.com/news/95/10929/usfda-completes-inspection-of-lupins-nagpur-plant.html https://biospectrumindia.com/news/95/10929/usfda-completes-inspection-of-lupins-nagpur-plant.html Mon, 14 May 2018 11:35:00 +0530 Pharma major Lupin today said the US health regulator has completed inspection of its Nagpur facility without making any observations. In a BSE filing, Lupin "announced successful completion of an inspection carried out by the United States Food and Drug Administration (USFDA) at its Nagpur facility. The inspection concluded without any observations". Lupin said its Nagpur facility manufactures oral solid products. ]]> <![CDATA[Nightingales Home Health opens branch in Chennai]]> https://biospectrumindia.com/news/95/10921/nightingales-home-health-opens-branch-in-chennai.html https://biospectrumindia.com/news/95/10921/nightingales-home-health-opens-branch-in-chennai.html Fri, 11 May 2018 13:40:00 +0530 Nightingales Home Health Services, a Medwell Ventures company, announced its entry into Chennai, as a part of its plans to expand amidst increasing demand for post-hospitalization care is on the rise. In Chennai, its first branch has come up in Adyar with a multi-disciplinary team consisting of doctors, nurses, physiotherapists, respiratory therapists and wound care therapists. The branch has started with 25 people. Four more branches will be set up in 12-18 months. Nightingales aims to establish a home healthcare delivery network in 10 metro clusters and increase its subscriber base to over 500,000 families by 2020 Chennai is the fifth city of their foray, after Bengaluru, Mumbai, Pune and Hyderabad, the next on the list being Delhi ]]> <![CDATA[Indian Intellectual Property and liabilities law creates obstacle to invest in pharma sector]]> https://biospectrumindia.com/news/95/10917/indian-intellectual-property-and-liabilities-law-creates-obstacle-to-invest-in-pharma-sector.html https://biospectrumindia.com/news/95/10917/indian-intellectual-property-and-liabilities-law-creates-obstacle-to-invest-in-pharma-sector.html Fri, 11 May 2018 11:05:00 +0530 India’s intellectual property regulations and liabilities laws pose a major barrier to foreign companies, specially from the US, that prevents them from increasing their footprint in the countrys huge market, pharma sector leaders have said. Andrew Plump, chief medical and scientific officer of Takeda Pharmaceuticals, a major Japanese drugmaker, said his company has a very limited presence in India. "But it is open to increase its footprint in India, with the improvement in IP protection laws and those related to liabilities," Plump said. "Historically it (IP sector regulations and liabilities law) has been not just a hindrance but a barrier and impediment (for the US pharma companies to invest in India),"he added. On Tuesday, Takeda announced plans to acquire London-listed Shire Plc for USD 62 billion, which is being described as the biggest ever overseas acquisition by a Japanese company. "Our geographical spread hasn’t taken us to India, which is quite unusual for us because we’re a company that thinks about patients and access and there’s such a huge unmet medical need in India. So, I am hopeful that as we move forward well find ways to bring medicines to patients in India," he said. Observing that India has outstanding data scientists, strong capabilities that it has in the pharma sector, Plump said relative to the academic excellence in India, relative to the population size and, a concentration in healthcare, "its underrepresented in R&D" in healthcare. According to the India Brand Equity Foundation, Indias pharmaceutical industry is expected to grow to USD 100 billion by 2025. William W Chin, professor of Medicine, Emeritus, Harvard Medical School acknowledged that it is important that the ecosystem that helps one discover and develop medicines focus on meeting great unmet medical needs. Noting that the Indian government has made good progress recently, Chin said changes in science and regulatory policy which allows for more rapid development of medicines. "But I think that the government will need to continue to invest in those academic groups and even companies want to innovate. They have to provide additional incentives for companies to solve the problems, but also create medicines that could be used for the global market as well, in which case it becomes very important to help the economy of India also," Chin said. Karun Rishi, head of the US India Chambers of Commerce, which organizes the annual US-India Biopharma and Healthcare Summit, said that India can be a significant player in artificial intelligence, machine learning and blockchain technologies. "The use of Blockchain can add muscle to the digital economy especially in the Biopharma and healthcare sector. This is one area, we see India playing a significant role globally," Rishi said. The 12th edition of the annual biopharma and healthcare summit attracted top corporate leaders from the American pharma sector with a collective research and development budget of more than USD 50 billion. During the day-long session, scientists, academicians and experts from the sector brain stormed on various aspects of India’s biopharma and healthcare sector ]]> <![CDATA[MannKind to enter deal with Cipla for Afrezza in India]]> https://biospectrumindia.com/news/95/10909/mannkind-to-enter-deal-with-cipla-for-afrezza-in-india.html https://biospectrumindia.com/news/95/10909/mannkind-to-enter-deal-with-cipla-for-afrezza-in-india.html Thu, 10 May 2018 13:20:00 +0530 MannKind Corporation announced an exclusive marketing and distribution agreement for Afrezza in India with Cipla Ltd., a global pharmaceutical company. MannKind Corporation is a company focused on the development and commercialization of inhaled therapeutic products for patients with diseases such as diabetes and pulmonary arterial hypertension. Afrezza is the only United States Food and Drug Administration (USFDA) approved inhaled insulin available for patients suffering from diabetes. Under the terms of the agreement, Cipla will be responsible for obtaining regulatory approvals to distribute Afrezza in India, including approval from the Drug Controller General of India (DCGI). Cipla will also be responsible for all marketing and sales activities of Afrezza in India. MannKind is responsible for supplying Afrezza to Cipla. ]]> <![CDATA[Lupin submits New Drug Application for Etanercept biosimilar in Japan]]> https://biospectrumindia.com/news/95/10901/lupin-submits-new-drug-application-for-etanercept-biosimilar-in-japan.html https://biospectrumindia.com/news/95/10901/lupin-submits-new-drug-application-for-etanercept-biosimilar-in-japan.html Wed, 09 May 2018 15:05:00 +0530 Pharma major Lupin announced that YL Biologics (YLB) – its JV with Yoshindo and Kyowa (Lupin’s Subsidiary) in Japan has submitted a New Drug Application (NDA) for Marketing Authorization to the Pharmaceuticals and Medical Devices Agency (PMDA) for a biosimilar of Etanercept (YLB113) to treat indications for moderate to severe Rheumatoid Arthritis (RA) and Juvenile Idiopathic Arthritis. YL Biologics  and Kyowa filed the NDA in Japan in March, 2018. Nilesh Gupta, Managing Director of Lupin Limited said, “The application for Etanercept biosimilar is a significant milestone for Lupin as we build our biosimilars pipeline. With the application now filed, we are preparing to launch an affordable and high-quality biosimilar for consumers in Japan. This is an encouraging outcome as we make a strategic shift across Lupin to higher complexity products.” In February this year, YL Biologics announced the successful conclusion of its global Phase III study of biosimilar of Etanercept (YLB113). The study was a multinational randomized double-blind controlled trial of 52 weeks duration which included more than 500 patients with rheumatoid arthritis (RA) in 11 countries. It compared YLB113’s efficacy and safety directly against Enbrel® (of Pfizer). The study was conducted at 110 rheumatology clinics across Japan, Europe and India. This study included over 260 Japanese patients from 62 rheumatology clinics, a scale that is distinct for a global RA trial in Japan. According to Dr. Toshihiko Hibino, President of YLB, “This application marks the first biosimilar developed as part of the JV between Lupin and Yoshindo. We are excited by the development which is a complex fusion protein for a regulated market like Japan, and will help make the product accessible to the patients. The Biologics market in Japan is expected to reach $13.5 Billion (1480 Bn JPY) next year and the current healthcare spends on biologics is around 14% by the government in Japan and this is expected to rise in the coming years.” Dr. Cyrus Karkaria, President, Lupin Biotech said, “Etanercept is used globally in the fight against a range of severe autoimmune disorders. The successful filing and eventual approval of YLB113 is a major step in the fight against these diseases, and will allow access to an effective, affordable equivalent.” “After significant investment in our biotechnology R&D division over the years, this is the first biosimilar for regulated markets developed in-house at Lupin and the first ever complex fusion protein like etanercept in regulated markets by an Indian pharmaceutical player. It is an important achievement for us that sets the tone for future developments”, he added. This filing also opens up other key markets like Europe, Canada, Australia, the Middle East, South East Asia and Latin America for this product. The approvals for these markets are expected within the next 12 to 18 months timeframe. The ex-US market for Etanercept is estimated at USD 4 billion in Japan and Europe along with other regulated and emerging markets. Lupin is also on course with its plans for filing in the US and is targeting a filing in FY 2019-20.   ]]> <![CDATA[Lupin receives FDA approval for generic Temovate Ointment, 0.05% ]]> https://biospectrumindia.com/news/95/10900/lupin-receives-fda-approval-for-generic-temovate-ointment-0-05-.html https://biospectrumindia.com/news/95/10900/lupin-receives-fda-approval-for-generic-temovate-ointment-0-05-.html Wed, 09 May 2018 15:00:00 +0530 Pharma major Lupin announced that it has received final approval for its Clobetasol Propionate Ointment USP, 0.05% from the United States Food and Drug Administration (FDA) to market a generic version of Fougera Pharmaceuticals Inc.’s Temovate Ointment, 0.05%. Lupin’s Clobetasol Propionate Ointment USP, 0.05% is the AB rated generic equivalent of Fougera Pharmaceuticals Inc.’s Temovate Ointment, 0.05%.  It is indicated for relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses. Clobetasol Propionate Ointment USP, 0.05% had annual sales of approximately 120 million in the US (IQVIA MAT January 2018).   ]]> <![CDATA[LANXESS backings Tech empowered schooling to municipal schools in Jhagadia]]> https://biospectrumindia.com/news/95/10892/lanxess-backings-tech-empowered-schooling-to-municipal-schools-in-jhagadia.html https://biospectrumindia.com/news/95/10892/lanxess-backings-tech-empowered-schooling-to-municipal-schools-in-jhagadia.html Tue, 08 May 2018 11:50:00 +0530 LANXESS India Private Limited, the leading specialty chemicals company reaffirmed its commitment to the region by supporting five schools in Jhagadia with interactive e-learning tools in a major push for quality education infrastructure. This followed the company’s efforts of improving the infrastructure facilities of two municipal schools Anganwadi School, Fulwadi and Secondary school in Selod.   Over the past years, LANXESS has closely worked with government and local communities to conduct various CSR initiatives in the field of Health and Education. LANXESS believes that it is their inherent responsibility to support education as it is among the necessary building blocks for any developing country. In 2017 – 2018, the company initiated key CSR outreach projects in Jhagadia and its surrounding region for providing better education. LANXESS contributed towards upgradation of the municipal schools by providing best in class infrastructure and amenities. The company announced the completion of its CSR projects in an event which was held on the 3rd of May, 2018 in the presence of Utpal Kachchhi, Head-Site Infrastructure, LANXESS Jhagadia and Sunder Rajan, Head – CSR, LANXESS India. LANXESS took strong steps to integrate technology into the education system and supported the digital classroom initiative by installing interactive e-learning tools in five schools in Jhagadia namely  Fulwadi Primary school, Kapalsadi Primary school, Kapalsadi government secondary school, Selod Primary school and St.Xavier’s High school, Gujarati. The e-learning tools will help in familiarizing students with the technological advances in education that the students from urban regions enjoy. These tools have pre-loaded content for students that are mapped with the education board. They are loaded with virtual activities like 2D and 3D graphics, voice overs and interactive content among others and helps the students as well as the teachers in explaining and understanding basic concepts.This project is in line with LANXESS’ vision of a digital future and also finds resonance with the current government’s focus on creating a digitally empowered nation.  In Fulwadi and Selod, LANXESS undertook initiatives to renovate the school building and play area for children and incorporated various facilities like watercoolers, ceiling fans, toilet blocks, repairing of school gate and painting the boundary walls among others.   ]]> <![CDATA[Vidhi to head consumer healthcare biz at Sun Pharma ]]> https://biospectrumindia.com/news/95/10866/vidhi-to-head-consumer-healthcare-biz-at-sun-pharma-.html https://biospectrumindia.com/news/95/10866/vidhi-to-head-consumer-healthcare-biz-at-sun-pharma-.html Wed, 02 May 2018 17:35:00 +0530 Sun Pharmaceutical Industries, India’s largest drug maker, may be struggling to rebuild its generic business, but billionaire founder Dilip Shanghvi is putting in place a succession plan, handing over some of the reins of the company to his children.  Three years after son Aalok Shanghvi was inducted as emerging markets head of Sun Pharma, the company introduced daughter Vidhi Salgaocar as head of the Consumer Healthcare business, a separate division, on Monday. The announcement was made at the launch of its over-the-counter anti-fungal product ABZORB.  A graduate in economics from the Wharton School of the University of Pennsylvania, Salgaocar joined Sun Pharma in 2012. Before officially taking charge as head of the consumer division she led the marketing function of the India business.  Salgaocar played a “major role in developing the nutrition business of Sun Pharma and spearheaded the company’s strategy to enter the nutrition space,” said a company official. “Fungal infections are a common occurrence and are often left untreated because of the associated social stigma,” Salgaocar said in a statement. The marketing campaign will raise consumer awareness regarding fungal infections and empower them to treat the infection, she said. Sun Pharma’s consumer healthcare division has five key brands including Revital H and Volini, according to the company website. Sun Pharma CHC said its sales and distribution strategy involves penetrating up to Class II towns directly and smaller towns through the ‘hub and spoke’ model.    ]]> <![CDATA[BioAgile Therapeutics wins recognition for fast growth]]> https://biospectrumindia.com/news/95/10859/bioagile-therapeutics-wins-recognition-for-fast-growth.html https://biospectrumindia.com/news/95/10859/bioagile-therapeutics-wins-recognition-for-fast-growth.html Wed, 02 May 2018 11:25:00 +0530 BioAgile Therapeutics Private Limited was honoured as “The Fastest Growing Indian Company Award” presented with deep appreciation by the Deputy Prime Minister of Thailand Mr. Korn Dabbaransi and Princess Isabelle Lafforgue at 10th International Achievers summit on “Global Corporate Achievements and Social Responsibilities” organized by the International Achievers Conference on Friday, April 20 2018 in Bangkok, Thailand. The Founder and CEO of BioAgile Therapeutics Ms. Divya Chandradhar received this prestigious award followed by a Certificate of Excellence. The award also recognizes the rapid growth of the company and up surging on its way of providing best in class clinical services in short span of time after the establishment. The CEO during the award ceremony also added, “It gives me immense pleasure to be receiving this prestigious award representing our Country and Organization. I would also like to thank everyone in BioAgile team, for this outstanding achievement, wouldn’t have done it without your support”. ]]> <![CDATA[Trivitron to set up new facilities across India]]> https://biospectrumindia.com/news/95/10855/trivitron-to-set-up-new-facilities-across-india.html https://biospectrumindia.com/news/95/10855/trivitron-to-set-up-new-facilities-across-india.html Tue, 01 May 2018 21:10:00 +0530 Chennai-based medical diagnostics company Trivitron Healthcare is planning to invest Rs100 crore in the next 12-18 months, which will go into creating new manufacturing facilities and rolling out new products. Through nine manufacturing facilities spread across India, Finland, and Turkey, Trivitron manufactures products across IVD segment, imaging products (ultrasound/X-ray/X-ray accessories), radiation protection products, intensive care (ICU), operation theatre, dialysis, and newborn screening products. The company will be adding two more manufacturing facilities, one in Chennai to make operation room equipment with an investment of Rs15 crore. Another facility will come up in Pune which will make X-ray equipment. The company is waiting for approvals for this facility. In the coming 1-2 years, Trivitron plans to develop a series of new products that will include point-of-care devices, self-testing devices for thyroid and other disorders and deficiencies. ]]> <![CDATA[Govt’s new regulations to define 'stem cell therapy' from 'stem cell drug']]> https://biospectrumindia.com/news/95/10851/govts-new-regulations-to-define-stem-cell-therapy-from-stem-cell-drug.html https://biospectrumindia.com/news/95/10851/govts-new-regulations-to-define-stem-cell-therapy-from-stem-cell-drug.html Mon, 30 Apr 2018 12:25:00 +0530 Stem Cell Society of India had organized its 4th international conference SCSICON 2018 in Delhi on April 28th and 29th in New Delhi. This year was the 4th annual international conference of the society. “When the Prime Minister’s new and ambitious ‘Ayushman Bharat’,the National Health Protection Scheme, becomes operational, Stem cell therapy for providing relief to the disabilities in the ‘Rights of Persons with Disabilities Act,2016 may be considered for inclusion under this scheme” Honorable Minister of Health &Family Welfare,Govt.of India,Shri Jagat Prakash Nadda  mentions in a message for the SCSICON 2017-18 souvenir.   “The Drugs and Cosmetics Rules, 1945 are proposed to be amended to provide regulation of Stem Cell based drugs. At the same time, the stem cell based drugs are demarcated from stem cell therapy not to overstep the role of the treating physician”- Dr. S Eswara Reddy, Drug Controller General (India)   DrAlok Sharma, President, StemCell Society of India said “The focus of the discussion in the conference was about the regulations for stem cell therapy in India. The scientists and doctors are hopeful about the future of stem cell therapy and welcome the new Indian Gazette. The progressive changes suggested in the Indian Drugs and Cosmetics Rule are highly appreciated.   As per the Gazette of India published on 4th April 2018; following additions are suggested as amendment of the Drugs and Cosmetics Rule, 1945. As per this Gazette it is proposed that, minimally manipulated stem cells will not be considered as ‘ a Drug’ and therefore will be excluded from the Drugs and Cosmetics Rule; while the more than minimally manipulated and substantially manipulated stem cells will be considered as ‘a drug’ and will therefore be under the purview of the Drugs and Cosmetics Rule.” Dr Alok Sharma explaining and elaborating further on the new regulations said, “Cells or tissues taken from the patients body, subjected to cleaning and separation for administering immediately without multiplying outside the body is termed as minimally manipulated cells. This is “stem cell therapy” which is under the surgeons or clinicians purview as opposed to “stem cell drugs” which would be a product or a drug. The cells or tissues which are taken from the body, multiplied in the laboratory or undergoes any genetic manipulation and stored in the laboratory to be used by the same patient or another patient are termed as more than minimally manipulated and these would be termed as “drugs” as per the amended Drugs and Cosmetics Act 1945 and will need to go through screening and trials as is expected from a new drug”.   DrAlok Sharma further said “These changes are very progressive following the recent developments in countries like Japan, Korea and USA. This amendment will facilitate growth of cell therapies in India and will also make these therapies available to lakhs of patients who are currently suffering with incurable diseases.” ]]> <![CDATA[LKKHPG Named One of the Best Companies to Work for in Asia 2018]]> https://biospectrumindia.com/news/95/10847/lkkhpg-named-one-of-the-best-companies-to-work-for-in-asia-2018.html https://biospectrumindia.com/news/95/10847/lkkhpg-named-one-of-the-best-companies-to-work-for-in-asia-2018.html Mon, 30 Apr 2018 10:30:00 +0530 LKK Health Products Group (LKKHPG) was awarded as one of the Best Companies to Work for in Asia 2018 (Hong Kong Edition) by HR Asia Magazine, one of the most authoritative publications for senior HR professionals in Asia. It has won this honor for three consecutive years since 2016. Best Companies to Work for in Asia™ is one of the most authoritative business management awards in Asia. LKKHPG was one of the 33 winners this year out of 168 nominees from a dozen industries across Hong Kong. Other awardees include Swarovski, A.S. Watson Group, Hang Lung Properties, Pfizer, and KPMG.   "While the program is Asia-centric, the survey's parameters are benchmarked against the best in the world," said Mr. William Ng, group publisher and editor-in-chief of Business Media International, the publisher of HR Asia.   The Awards was judged by an independent panel of industry experts, academics, journalists and government representatives based on the HR Asia Employee Input Survey™ (EIS) Report and the HR Asia Workplace and Employee Engagement Survey™ (WEES).   The judges examined companies' HR practices, employee engagement, job satisfaction and workplace environment. The evaluation report shows that LKKHPG acquired high scores in all dimensions.   LKKHPG's care for and devotion to employees continue to earn widespread social recognition. In 2018, it was honored as a Caring Company again by the Hong Kong Council of Social Service, and named a Happy Company again by the Promoting Happiness Index Foundation and Hong Kong Productivity Council. ]]> <![CDATA[Mylan launches generic version of Oral Contraceptive Yaz]]> https://biospectrumindia.com/news/95/10841/mylan-launches-generic-version-of-oral-contraceptive-yaz.html https://biospectrumindia.com/news/95/10841/mylan-launches-generic-version-of-oral-contraceptive-yaz.html Thu, 26 Apr 2018 18:30:00 +0530 Global pharmaceutical company Mylan announced the U.S. launch of Drospirenone and Ethinyl Estradiol Tablets USP, 3 mg/0.02 mg, a generic version of Bayer's Yaz® Tablets. Mylan Pharmaceuticals received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product, which is indicated for use by women to prevent pregnancy and for the treatment of acne vulgaris in women at least 14 years of age who have achieved menarche and desire an oral contraceptive for birth control.   In the U.S., Mylan offers more than 20 generic birth control medicines in multiple dosage forms. The products are a part of Mylan's growing U.S. women's healthcare portfolio, which includes a vast suite of medicines to help women manage their health across all the stages of their lives.   Women over 35 years old who smoke should not use Drospirenone and Ethinyl Estradiol Tablets USP, 3 mg/0.02 mg. Cigarette smoking increases the risk of serious cardiovascular events from combination oral contraceptive use.   ]]> <![CDATA[PULSUS inks agreement with 25 Scientific and Healthcare societies]]> https://biospectrumindia.com/news/95/10839/pulsus-inks-agreement-with-25-scientific-and-healthcare-societies.html https://biospectrumindia.com/news/95/10839/pulsus-inks-agreement-with-25-scientific-and-healthcare-societies.html Thu, 26 Apr 2018 13:15:00 +0530 Realizing the great potentialities of the European countries including Germany, Spain, Netherlands, France and Portugal, PULSUS Group announced their expansion of its scientific research and publication activities to Europe apart from the Asia Pacific, Middle East, and America. To establish its operations into these new markets PULSUS inked a mutual partnership agreement with 25 scientific and healthcare societies. The latest addendum to this initiative is support from the European region which includes Polish Society of Orthopaedics and Traumatology, European Biotechnology Thematic Network Association, World Federation of Pediatric Intensive and Critical Care Societies, International Society for Ceramics in Medicine, Thalassaemia International Federation and World Association of Integrated Medicine and Switch Biotech Association. Recently Belgium High commission team and Mr. Jean François AERNOUTS visited PULSUS office at Hyderabad to sign an arrangement to establish PULSUS center in Belgium. With the support from industry and academia, Pulsus and its subsidiaries omics international, meetings international and conference series will be able to schedule 3,000 global annual events in 40 countries for 2018. These conferences attract 50 million+ visitors, 25000+ unique visitors per conference and 75000+ page views for every individual conference would help in quantifying every presenter's research and biography visibility to the online communities and get recognized worldwide. “This expansion will create another 1000 jobs in Hyderabad to provide the backend Knowledge Process Outsource outsource (KPO) support services from our Hyderabad SEZ Units.” Dr. SrinuBabu CEO of PULSUS said. Pulsus meetings provide a high-class opportunity to the nurse practitioners to publish their abstract and full-length article in the respective journals. Speaker’s profiles displayed on the conference websites give a special recognition to the new nursing practitioners. Pulsus Meetings also provides CME, CPD, CE and CNE credit essential to maintain competency. ]]> <![CDATA[India, World Bank to invest into Biopharmaceutical Industry]]> https://biospectrumindia.com/news/95/10836/india-world-bank-to-invest-into-biopharmaceutical-industry.html https://biospectrumindia.com/news/95/10836/india-world-bank-to-invest-into-biopharmaceutical-industry.html Thu, 26 Apr 2018 12:10:00 +0530 The Government of India and the World Bank have recently signed a $125-million agreement to support India in developing an innovative biopharmaceutical and medical devices industry, which aims to be globally competitive and addresses the country’s major concerns around barriers to affordable healthcare. The $125 million loan from the International Bank for Reconstruction and Development (IBRD), has a 5-year grace period, and a maturity of 19 years. The agreement was signed by Mr Sameer Kumar Khare, Joint Secretary, Department of Economic Affairs, Ministry of Finance, on behalf of the Government of India; Mr Mohd. Aslam, Managing Director, Biotechnology Industry Research Assistance Council (BIRAC); and Mr Hisham Abdo, Acting Country Director, World Bank India. The project will also promote industry-academia interface and enable start-ups and small and medium enterprises to build innovation research capacities for developing affordable healthcare products. ]]> <![CDATA[WELTEC BIOPOWER Expands Plant Lineup in Northern Ireland]]> https://biospectrumindia.com/news/95/10829/weltec-biopower-expands-plant-lineup-in-northern-ireland.html https://biospectrumindia.com/news/95/10829/weltec-biopower-expands-plant-lineup-in-northern-ireland.html Wed, 25 Apr 2018 11:45:00 +0530 German biogas specialist WELTEC BIOPOWER is currently building three anaerobic digestion plants in Northern Ireland. All three 500-kW plants will shortly be completed and will go live in summer 2018. Two of them are being set up in County Antrim in north-east Northern Ireland. Another plant is being built in Benburb in County Tyrone. Thus, WELTEC will soon account for nine of a total of about 40 biogas plants in Northern Ireland. In recognition of this strong overseas commitment, WELTEC BIOPOWER recently qualified for the second place in the ranking of the German Foreign Trade Award.  At first glance, the three new 500-kW plants look similar. Henceforth, all biogas plants will largely be charged with slurry and pig, cattle and poultry manure as well as a small amount of renewable raw materials. Nevertheless, the WELTEC engineers have developed an individual concept for each plant, as the substrate composition and retention times vary. For example, the plant in County Antrim will only have one 2,625-m3 stainless-steel digester. The second plant, which is located nearby, provides for two digesters with a capacity of 2,625 m3 each. The plant in Benburb will use a slightly larger stainless-steel digester in order to extract as much energy as possible from the substrates. The strong market position of WELTEC in the United Kingdom has a solid basis. From the outset, the company from Lower Saxony has played a key role in the field of AD plant construction. On 19 April 2018, the award was conferred for the 10th time. The ceremony was conducted at the end of the German Foreign Trade Day by Dr. Carsten Sieling, mayor of Bremen, and Harald Emigholz, Chairman of the Bremen Chamber of Commerce.              Specifying the reasons for the bestowal of the award, the jury pointed out that WELTEC BIOPOWER started engaging in foreign trade as early as a year after its foundation in 2001. Today, more than 300 WELTEC plants exist in 25 countries on five continents. At present, additional energy plants are being built in Uruguay, France, Croatia and Greece. The export of German regenerative energy know-how has greatly contributed to WELTEC's sales and earnings performance. True to its convictions, WELTEC has retained the main elements of its value chain in the region and in Germany. In this way, the company provides its customers around the globe in various industries with a consistent quality level. ]]> <![CDATA[Alivira acquires Cadila’s animal health biz in Germany]]> https://biospectrumindia.com/news/95/10828/alivira-acquires-cadilas-animal-health-biz-in-germany.html https://biospectrumindia.com/news/95/10828/alivira-acquires-cadilas-animal-health-biz-in-germany.html Wed, 25 Apr 2018 11:05:00 +0530 Mumbai-based pharmaceutical company SeQuent Scientific's subsidiary Alivira Animal Health Ltd has acquired 100 per cent stake in Cadila Healthcare’s animal health business in Germany. Alivira Animal Health, through Alivira Ireland, has bought Bremer Pharma GmbH from Cadila for an enterprise value of 2.26 million euros ($2.8 million). Founded in 1982, Bremer Pharma is a veterinary health company in Germany which focuses on the cattle and swine segments. It has an injectable manufacturing facility. This acquisition provides Alivira's with a beta-lactam & non-beta lactam injectables facility for EU markets, which compliments its Orals & Powders beta-lactam and non-beta lactam facility based at Barcelona in Spain. EU is Alivira's largest market accounting to 60 per cent of revenues.   ]]> <![CDATA[SRL to expand its diagnostic centres in Kolkata]]> https://biospectrumindia.com/news/95/10824/srl-to-expand-its-diagnostic-centres-in-kolkata.html https://biospectrumindia.com/news/95/10824/srl-to-expand-its-diagnostic-centres-in-kolkata.html Tue, 24 Apr 2018 16:00:00 +0530 SRL Diagnostics will nearly double its pathology centre network in Kolkata over the next three months. The company is in the process of opening new centres across Kolkata including Kankurgachi, Kasba and Ranikuthi. The first centre in Kolkata will come up on Maniktala main road. With the launch of these flagship centres, SRL Diagnostics would have eight company-owned pathology centres in the city. The expansion in Kolkata is part of the company’s plans to improve its focus on patient care and will also involve new centres opening up across the country in the near future, the company release stated. The newly launched spacious pathology centres serve a comprehensive menu of more than 3500 tests, performed under the supervision of highly experienced pathologists, the release added. Presently, SRL carries out around 1.25 lakh tests a day across a network of 376 laboratories and a footprint spanning more than 6300 collection points. The company also has large labs in the UAE, Sri Lanka and Nepal, and about 70 collection points in various countries outside India. The company hopes to provide customised healthcare options to the residents of Kolkata.   ]]> <![CDATA[Pharma formulators diverge on strategy for NP biz]]> https://biospectrumindia.com/news/95/10801/pharma-formulators-diverge-on-strategy-for-np-biz.html https://biospectrumindia.com/news/95/10801/pharma-formulators-diverge-on-strategy-for-np-biz.html Wed, 18 Apr 2018 14:30:00 +0530 India Ratings and Research (Ind-Ra) expects Indian formulators to continue to make investments to grow their domestic non-prescription business through organic and inorganic routes. This would be driven by the need to further diversify the domestic prescription business. Strong fundamentals will aid Indian formulators’ increased focus with an expected CAGR of 8.8% over 2017-2022 for the domestic over the counter (OTC) market. Investments by Indian formulators are likely to be in consumer healthcare and wellness products, apart from the traditional OTC product categories through new launches, brand extensions and switches from prescription products. This strategy is in sharp contrast to some global majors looking for strategic alternatives to exit their mature consumer health business owing to low single-digit growth and shift in focus back to the core prescription business. The agency believes the non-prescription business to contribute a solid 15%-20% to the domestic revenues of Indian formulators over the next five years. Structurally, the margin and return profile of an optimised non-prescription business with a mix of OTC, consumer and wellness products is structurally better than that of an acute prescription portfolio, but may significantly be lower than that for a chronic prescription portfolio. The profitability from a non-prescription business happens with a lag, subject to significant investments in media spends and distribution to establish/enhance consumer appeal or brand recall. The agency believes that large Indian formulators with demonstrated brand building capabilities and established distribution network can break-even faster and achieve profitability early. While FMCG players are likely to maintain market leadership in consumer products, competition for Indian formulators is expected to be moderate due to inherent strengthens and limited product overlap. ]]> <![CDATA[China’s Fosun becomes a competitor in the race for Fortis ]]> https://biospectrumindia.com/news/95/10795/chinas-fosun-becomes-a-competitor-in-the-race-for-fortis-.html https://biospectrumindia.com/news/95/10795/chinas-fosun-becomes-a-competitor-in-the-race-for-fortis-.html Wed, 18 Apr 2018 11:25:00 +0530 China’s Fosun international group has become the fourth suitor for cash-strapped hospital chain Fortis healthcare signalling a bidding war is in the works for the company after a TPG-Manipal combine, Malaysia’s IHH healthcare and Munjal-Burman family combination have made offers for the company. Fortis healthcare confirmed in a late night stock exchange filing on Tuesday that hong kong stock exchange-listed Fosun had made an ‘unsolicited’ non-binding expression of interest for the company, through its wholly-owned subsidiary Fosun Health Holdings.  Fosun has offered to invest upto $350 million in the hospital chain provided it is given a three week timeframe to conduct due diligence on the company. It also said it was willing to make a preliminary investment of Rs. 100 crore in the company through a convertible debt instrument, according to the stock exchange filing. Fosun has offered to subscribe to fresh shares in fortis healthcare at a price of Rs.156 per share and said its investment would cap its shareholding in the company at below 25%. Fosun has assets of $75 billion and an existing investment in India’s Gland Pharma, which it purchased from US buyout giant KKR. The company has invested over $1 billion in India and has been aggressively scouting for assets across sectors.   ]]> <![CDATA[AstraZeneca strengthens innovation partnership in India]]> https://biospectrumindia.com/news/95/10792/astrazeneca-strengthens-innovation-partnership-in-india.html https://biospectrumindia.com/news/95/10792/astrazeneca-strengthens-innovation-partnership-in-india.html Tue, 17 Apr 2018 20:40:00 +0530 Leading global science-led biopharmaceutical company AstraZeneca has announced its decision of further investing $ 90 million over the next 5 years in India. The announcement was made following a meeting between the company’s Executive Vice President for International Region – Mr. Leon Wang and Honorable Prime Minister of India, Shri Narendra Modi, during the latter’s visit to Sweden, where the two countries signed a joint declaration on innovation partnership for a sustainable future. This investment commitment will span across AstraZeneca’s diverse footprint in India with an aim to strengthen its manufacturing, clinical operations, patient safety & regulatory science, IT services and commercial operations. Furthermore, this investment will support scientific data generation, quality manufacturing, science talent development and collaborative development of innovative solutions to improve the standard of care of non-communicable diseases in India. The commitment also aligns closely with the Indian government’s initiatives to create a stronger business, innovation, and healthcare environment such as “Skill India”, “National Health Policy” and “Ayushman Bharat.”    Leon Wang, Executive Vice President for International Region, AstraZeneca, said “AstraZeneca has a long-standing commitment in India of 40 years. Our latest investment reflects our commitment to address the unmet needs in non-communicable diseases, enable high-value job creation and boost medical innovation in the country. We believe, this investment commitment across AstraZeneca’s business footprint in India, will make a positive impact. It also aligns closely with the government’s vision for healthcare and innovation.” AstraZeneca’s strategy in India is to address the growing burden of non-communicable diseases. The company invests in many initiatives and programs such as the Young Health Programme, Early action in Diabetes & Healthy Lung for early action in awareness, prevention, detection and holistic management of non-communicable diseases.   At present, AstraZeneca has a workforce of over 4000 employees in India spanning manufacturing, sales and marketing, clinical operations, IT services, digital services and Global medicines development. The company recently announced expansion of its Global Technology Centre (GTC) in Chennai, now employing more than 2000 employees. GTC is AstraZeneca’s first, insourced IT facility. AstraZeneca’s manufacturing facility in Bengaluru has a sophisticated production facility designed to meet the most stringent international standards, conforming to World Health Organisation cGMP (current Good Manufacturing Practices) norms. AstraZeneca also has a sizeable clinical operation and is expanding its Global medicines development unit that focusses on patient safety and regulatory science in India. ]]> <![CDATA[GE launches new facility for viral vector based therapeutics]]> https://biospectrumindia.com/news/95/10790/ge-launches-new-facility-for-viral-vector-based-therapeutics.html https://biospectrumindia.com/news/95/10790/ge-launches-new-facility-for-viral-vector-based-therapeutics.html Tue, 17 Apr 2018 17:40:00 +0530 GE Healthcare is launching a ready-to-run factory-in-a-box to speed up the production of viral vector based therapeutics, including viral vector based vaccines, oncolytic viruses and gene and cell therapies. The new, prefabricated and modular KUBio biomanufacturing facility is designed, constructed, assembled and fully fitted-out to current good manufacturing practice (cGMP) standards significantly faster that is required to build a traditional, stick-built manufacturing facility. This makes it possible to build capacity quickly and easily, allowing drug manufacturers to adapt to market requirements. The factory is also pre-engineered so that it can be expanded at a later stage to offer increased manufacturing output according to the drug demand.  Viral vectors are modified viruses that are being used as vehicles (or ‘carriers’) to deliver genetic material into target cells. They protect the new gene from degradation, while delivering it to the target cells that start using the new genetic code to cure or treat a certain disease. GE’s newest KUBio is designed for products requiring a biosafety level 2 (BSL2) environment such as viral vector based therapies, but even monoclonal antibody (mAb) and multi-product manufacturers can use the facility. The standard KUBio BSL2 includes a FlexFactory single-use biomanufacturing platform, where the recommended bioreactor size is between 200 and 1,000 liters. The facility can be extended with a larger, or additional manufacturing suite according to the market need. As a part of the project, GE provides end-to-end bioprocessing support including manufacturing equipment, a prefabricated modular facility and accompanying suite of services, including installation, financial guidance, project coordination, qualification and equipment maintenance services. GE already offers a prefabricated manufacturing solution, KUBio for the production of monoclonal antibodies (mAbs), a FlexFactory biomanufacturing platform for a variety of biologics and most recently, a scalable FlexFactory platform for cell therapy. Three KUBios and over 40 FlexFactories have already been purchased globally.   ]]> <![CDATA[Sanofi to sell generics arm to Advent for $2.4B]]> https://biospectrumindia.com/news/95/10787/sanofi-to-sell-generics-arm-to-advent-for-2-4b.html https://biospectrumindia.com/news/95/10787/sanofi-to-sell-generics-arm-to-advent-for-2-4b.html Tue, 17 Apr 2018 15:25:00 +0530 French healthcare group Sanofi is in exclusive talks to sell its Zentiva European generics drugs arm to private equity firm Advent International for 1.9 billion euros ($2.4 billion). Sanofi said the sale was expected to be completed before the end of the year, and Advent's offer was binding and fully financed. The 1.9 billion euros price is an enterprise value, including equity and debt. The planned Zentiva sale follows a move by UK group Shire this week to sell its oncology business to unlisted French drugmaker Servier for $2.4 billion.  Sanofi has been reshaping its business in recent months, spending more than $16 billion to buy biotech company Ablynx and U.S. haemophilia specialist Bioverativ, but also selling off some assets. This week, it sold some brands to Charterhouse Capital Partners' Cooper-Vemedia drugs manufacturing arm for 158 million euros. Zentiva operates in 50 markets and has a strong presence in Eastern Europe, particularly in the Czech Republic, Slovakia and Romania. ]]> <![CDATA[Glenmark Pharma to Initiate Phase 2b Trial of atopic dermatitis drug ]]> https://biospectrumindia.com/news/95/10786/glenmark-pharma-to-initiate-phase-2b-trial-of-atopic-dermatitis-drug-.html https://biospectrumindia.com/news/95/10786/glenmark-pharma-to-initiate-phase-2b-trial-of-atopic-dermatitis-drug-.html Tue, 17 Apr 2018 13:25:00 +0530 Drug major Glenmark Pharmaceuticals has announced initiation of phase 2b clinical trial of GBR 830, a novel investigational treatment for moderate-to-severe atopic dermatitis. According to company, the trial's primary endpoint will assess the efficacy of GBR 830, compared to placebo. Secondary and exploratory trial endpoints include additional measures of efficacy, safety and pharmacodynamics. Trial enrollment is expected to begin in June 2018, it added.  Glenmark said in addition to moderate-to-severe atopic dermatitis, the company is also evaluating the potential for conducting studies with GBR 830 for the treatment of other inflammatory autoimmune conditions. Preparations for a clinical trial assessing GBR 830 for the treatment of systemic lupus erythematosus (SLE) are currently underway. ]]> <![CDATA[Malaysia's IHH: Fortis declines to involvement in buyout offer]]> https://biospectrumindia.com/news/95/10780/malaysias-ihh-fortis-declines-to-involvement-in-buyout-offer.html https://biospectrumindia.com/news/95/10780/malaysias-ihh-fortis-declines-to-involvement-in-buyout-offer.html Mon, 16 Apr 2018 13:15:00 +0530 Malaysia's IHH Healthcare said that India’s Fortis Healthcare Ltd declined to engage with the company regarding a takeover offer, citing binding agreements with other parties. IHH, one of Asia's largest healthcare operators, offered to buy Fortis last week at a price that values the hospitals chain at about $1.3 billion. Some of Fortis's minority shareholders are dissatisfied with the Manipal offer, and it is unclear if the IHH price appeals to them. A merger with a hospitals chain such as Manipal might make more sense, said an analyst with a brokerage in Mumbai, adding that more details of the IHH offer were needed. Fortis, which is under investigation over financial fraud, has seen interest from multiple parties since Manipal offered to buy it last month. Two Indian investors Sunil Munjal's Hero Enterprise and the Burman Family Office offered last week to make an investment worth 12.5 billion rupees ($191.5 million). On Monday the Malaysian firm said the Fortis board sent it a response letter indicating it was unable to engage with IHH due to binding agreements with Manipal Health Enterprises Private Limited, Manipal Global Health Services and TPG Asia. "Given the everchanging competitive dynamics, IHH reserves the right to pursue all necessary steps to ensure that the shareholders of Fortis are provided with the opportunity to realise the value inherent in our proposal," IHH had said in the letter. ]]> <![CDATA[Mylan, Biocon to launch Adalimumab Biosimilar in EU]]> https://biospectrumindia.com/news/95/10767/mylan-biocon-to-launch-adalimumab-biosimilar-in-eu.html https://biospectrumindia.com/news/95/10767/mylan-biocon-to-launch-adalimumab-biosimilar-in-eu.html Fri, 13 Apr 2018 10:35:00 +0530 Mylan and Biocon have agreed to accelerate introduction of adalimumab biosimilar in Europe through Mylan’s in-licensing arrangement with Fujifilm Kyowa Kirin Biologics (FKB).  FKB’s product is at an advanced stage of review and could potentially obtain approval in Europe in the second half of 2018.  “We believe that through this arrangement, Mylan could commercialize FKB’s Adalimumab in EU around market formation.  Biocon retains its economic interest in this arrangement vis-a-vis Mylan in line with its existing global collaboration with Mylan for monoclonal antibodies”, adds Biocon Spokesperson. ]]> <![CDATA[Aster DM to expand in TN for healthcare services]]> https://biospectrumindia.com/news/95/10761/aster-dm-to-expand-in-tn-for-healthcare-services.html https://biospectrumindia.com/news/95/10761/aster-dm-to-expand-in-tn-for-healthcare-services.html Thu, 12 Apr 2018 11:50:00 +0530 Aster DM Healthcare, a leading healthcare service provider in India and in GCC with presence in 9 countries, has entered into an agreement with Subramanya Constructions & Development Company Limited (SCDC), to construct a new hospital in Chennai. This 500 bedded, multi-specialty hospital is expected to be commissioned in 2020. The total project cost of the hospital is estimated at Rs 400 crore. Aster DM Healthcare operates 11 hospitals in South India with 4037 installed beds. Commenting on the expansion into the Chennai healthcare market, founder chairman and managing director of Aster DM Healthcare, Azad Moopen said, “Looking at the demand supply gap, there is a requirement for more hospitals in India in general and in Chennai in particular. With our presence in Kerala, Karnataka, Telangana, Andhra and Maharashtra, we believe that our presence in Tamil Nadu would benefit patients in the country. We also see India as a key market for Aster DM Healthcare in future.” Aster DM Healthcare is present in the Middle East, India and the Philippines with a large number of health facilities including 20 hospitals and 98 clinics. ]]> <![CDATA[Sundyota Numandis offers most researched probiotic product to India]]> https://biospectrumindia.com/news/95/10759/sundyota-numandis-offers-most-researched-probiotic-product-to-india.html https://biospectrumindia.com/news/95/10759/sundyota-numandis-offers-most-researched-probiotic-product-to-india.html Thu, 12 Apr 2018 11:05:00 +0530 Sundyota Numandis Group of companies, a global health oriented organization, has signed a pact with global probiotic leader Probiotical of Italy to offer world's most researched probiotic product Lactobacillus rhamnosus GG in Indian market. The product procured will be strategically marketed by Sundyota Numandis and Cipla - a leading healthcare organization in India. Lactobacillus rhamnosus GG is meant to support gastro-intestinal health and general well-being in children as well as adults with no adverse effects. It is also the world’s most scientifically studied probiotic. Sundyota Numandis has introduced the probiotic in a technologically superior and consumer compliant oro-dispersible powder form that is stable in Indian climate; and is called as Microbac GG. As a part of the pact, Sundyota Numandis procures coated oro-soluble L. rhamnosus GG from Probiotical, Italy and undertakes its manufacturing for the Indian market. It has introduced the product under the brand name ‘SuperFlora GG’. Additionally, Sundyota Numandis has entered into a strategic alliance with Cipla for parallel launch and co-marketing of the same product. Cipla has introduced the product as ‘Unobiotics’. Addressing the media, Dinesh Arora, MD & CEO, Sundyota Numandis Group of Companies said, “Sundyota Numandis is focused on providing safe human healthcare products and clinically proven therapies from non-chemical sources. Probiotics are going to become the mainstay in future healthcare. Keeping this in mind, we’re already associated with many leading probiotic companies of the world to offer the best of probiotic researches in India. Lactobacillus rhamnosus GG is globally the number one choice amongst probiotics. Our association with Probiotical facilitates the introduction of a stable form of this probiotic in India, whereas our alliance with Cipla extends its benefits to a larger consumer base. The Indian probiotic market is valued at approximately Rs. 1000 Crores and is growing at a rate of 15%. We estimate that in the first 12 months of launch, Microbac GG will attain a value of Rs. 30 Crores. We would be manufacturing 1 million sachets of Microbac GG every month. In future, we will also introduce L. rhamnosus GG in various formulations like drops and capsules”. L. rhamnosus GG has been globally available since 1990. Since then, it has been a preferred choice of healthcare professionals for various health conditions, particularly gastrointestinal complaints like diarrhoea of various types, Irritable Bowel Syndrome (IBS), Inflammatory Bowel Disease (IBD) etc. As the nature and sensitivity of L. rhamnosus GG does not allow it to survive in climatic conditions of high temperature and humidity (like India), it necessitates a technological advancement to increase its viability and stability. Probiotical (Italy) is a global leader for research and development of bacterial probiotic therapies. Probiotical has developed a unique probiotic coating technology (Microencapsulation) which increases L. rhamnosus GG’s survivability and stability during packaging, transportation, storage and consumption. Moreover, it offers five times more probiotic activity compared to uncoated L. rhamnosus GG. Also, its oro-dispersible form ensures significant consumer compliance. Francesco Girardo, Director Sales – Probiotical said, “We are really excited to have Sundyota Numandis as our partner. This alliance will result in the introduction of series of technologically advanced probiotics from Probiotical in India. With a like-minded partner as Sundyota Numandis, our association is bound to be long lasting”. In due course, the partnership between Sundyota Numandis and Probiotical will widen its scope of concurrence; and look at developing various new molecules that will address need gaps in Indian healthcare and are best suited to Indian patient profile. ]]> <![CDATA[Dr Reddy's gets EIR from USFDA for Mexico plant]]> https://biospectrumindia.com/news/95/10754/dr-reddys-gets-eir-from-usfda-for-mexico-plant.html https://biospectrumindia.com/news/95/10754/dr-reddys-gets-eir-from-usfda-for-mexico-plant.html Wed, 11 Apr 2018 11:15:00 +0530 Reddy's Laboratories has received establishment inspection report (EIR) from the US health regulator for its Cuernavaca facility in Mexico. The company had earlier said in a regulatory filing that audit of its active pharmaceutical ingredient (API) Cuernavaca plant in Mexico by the United States Food and Drug Administration (USFDA) was completed with zero observations. As per the USFDA, after the completion of an inspection of a facility, an EIR is issued to a company detailing inspectional findings. ]]> <![CDATA[Roche to launch startup in India]]> https://biospectrumindia.com/news/95/10747/roche-to-launch-startup-in-india.html https://biospectrumindia.com/news/95/10747/roche-to-launch-startup-in-india.html Tue, 10 Apr 2018 11:40:00 +0530 Swiss drug maker Roche is looking for startups in India that will help the company bring evidence-based medicine in India through its proprietary technology, according to the company’s newly appointed India head.  Lara Bezerra, Roche Managing Director (India), who moved from the troubled Venezuela market to India, told that as part of its long-term strategy the company can bring applications of Flatiron, a tech company that it acquired this year to India.  Flatiron Health is a market leader in oncology-specific electronic health record (EHR) software, as well as the curation and development of real-world evidence for cancer research. Roche during the acquisition of the company in February said that with its large network of community oncology practices and academic medical centres across the US, Flatiron Health has created a technology platform designed to learn from the experience of every patient. “When we are having this vision for India we realised that whatever you do in India you can’t do in short term. So we have to think something long term. So we are looking how we should bring Flatiron tech to India,” said Benzerra. “May be there is startup in India that can work with Flatiron so we are looking at all these options.”   ]]> <![CDATA[Beauty and wellness firm VLCC to expand internationally]]> https://biospectrumindia.com/news/95/10740/beauty-and-wellness-firm-vlcc-to-expand-internationally.html https://biospectrumindia.com/news/95/10740/beauty-and-wellness-firm-vlcc-to-expand-internationally.html Mon, 09 Apr 2018 12:05:00 +0530 Beauty and wellness firm VLCC is on the expansion spree with a target to add 50 new training institutes in India over the next five years.  The company, which has about 70 institutes in India, has also chalked out plans to foray into international markets such as Canada, Malaysia, Srilanka, Kenya, Oman and Bangladesh.  With the opening of more institutes, VLCC is eyeing a 35 per cent year on year revenue growth. In FY 2018, it had a turnover of Rs 55 crore for the skilled business.  "We will add 50 new institutes in India and also in countries such as Canada, Malaysia, Oman and Srilanka with a target to train approximately 15,000 students," said Mr.Sandeep Ahuja, Director VLCC Group.  The company offers about 100 courses and workshops in the beauty and wellness space and has trained over 1 lakh students so far.  The institutes have crossed the target of Rs 50 crore and are set to go over Rs 100 crore with international expansion by this fiscal end, as per the company.  With regard to retail expansion in the personal care category, Ahuja said VLCC has recently added close to 100 new distributors and is betting on the modern trade across national and regional customers besides giving leverage to the e-commerce.  The contribution from e-commerce was close to 15 per cent in FY 2018. Total turnover from personal care category stood at Rs 400 crore in the last financial year. The company has 197 wellness centres in India and markets over 169 skincare, haircare, bodycare, functional foods and fortified food products. ]]> <![CDATA[Lupin receives EIR from USFDA for Pithampur facility]]> https://biospectrumindia.com/news/95/10731/lupin-receives-eir-from-usfda-for-pithampur-facility.html https://biospectrumindia.com/news/95/10731/lupin-receives-eir-from-usfda-for-pithampur-facility.html Fri, 06 Apr 2018 12:45:00 +0530 Drug Pharmaceutical Company has received establishment investigation report (EIR) from the United States Food and Drug Administration (US FDA) for the successful inspection of Pithampur, Unit 1 manufacturing facility in Madhya Pradesh. The inspection was conducted in July 2017. USFDA gives EIR on closure of inspection of an establishment that is the subject of an FDA or FDA-contracted inspection. "The successful outcome of this inspection is encouraging, and further validates our commitment to meeting global manufacturing standards. We are committed to upholding the highest levels of quality and compliance standards across all our facilities,” said Nilesh Gupta, Managing Director, Lupin.   ]]> <![CDATA[Apax acquires Healthium MedTech for $350M]]> https://biospectrumindia.com/news/95/10730/apax-acquires-healthium-medtech-for-350m.html https://biospectrumindia.com/news/95/10730/apax-acquires-healthium-medtech-for-350m.html Fri, 06 Apr 2018 12:30:00 +0530 Apax Partners Llp has acquired Bengaluru-based medical devices company Healthium MedTech Pvt. Ltd (formerly known as Sutures India). British buyout fund Apax Partners is acquiring Healthium Medtech (HMPL) for $300 million (₹1,950 crore) from its existing private equity owners TPG Growth, which holds 73%, homegrown PE firm CX Partners and founding shareholders. This will be London-headquartered Apax’s second healthcare deal in India after its 2007 India debut with an investment in Apollo Hospitals Enterprises. Healthium is the country’s largest medical consumables and surgical sutures company. It also owns Quality Needles and UK-based Clini Supplies. The transaction would be the second major M&A for TPG within a week. Last week, it backed Manipal Health Enterprises to buy Fortis Healthcare. This will be Apax’s eighth investment in India for the Apax Funds over the past 11 years, having already deployed $2 billion in this country. Healthium manufactures and sells a broad range of medical devices and consumable products including wound closure products, minimally invasive products including endo surgery and arthroscopy consumables, and urology products. Through its strong pan-India distribution presence under the Sutures India division, Healthium sells its products across large and corporate hospitals, nursing homes, and government hospitals and institutions, and services over 10,000 hospitals across the country. It also exports products to 91 countries in Europe, South America, Africa and Asia. The Sutures India division of the company has a strong sales and distribution network in India comprising over 400 sales personnel and over 1,500 distributors. Backed by Apax, Healthium plans to further deepen its presence in the Indian market and broaden its portfolio of specialty medtech products.   ]]> <![CDATA[Natco launches generic drug for sclerosis in India]]> https://biospectrumindia.com/news/95/10727/natco-launches-generic-drug-for-sclerosis-in-india.html https://biospectrumindia.com/news/95/10727/natco-launches-generic-drug-for-sclerosis-in-india.html Thu, 05 Apr 2018 12:50:00 +0530 Drug firm Natco Pharma has launched a generic version of Teriflunomide tablets used for the treatment of relapsing and remitting forms of multiple sclerosis in India. The company has launched the product under brand name 'Denopsy', Natco Pharma said. "This is the first oral medicine for relapsing and remitting forms of multiple sclerosis being offered in India at two different strengths - 14 mg and 7 mg tablets" it added. Teriflunomide is sold by Sanofi-Genzyme under the brand name of Aubagio in the US market, Natco Pharma said.  The generic product is priced much lower than other alternate options in India. ]]> <![CDATA[Roche launches new cancer drug in India]]> https://biospectrumindia.com/news/95/10723/roche-launches-new-cancer-drug-in-india.html https://biospectrumindia.com/news/95/10723/roche-launches-new-cancer-drug-in-india.html Thu, 05 Apr 2018 11:30:00 +0530 Multinational healthcare company Roche has launched monoclonal antibody atezolizumab under the brand name Tecentriq in India for treatment of lung and bladder cancer. According to Roche, Tecentriq has shown to extend survival and improve the quality of life in the approved indications. The product has been approved in India for two types of cancers- non-small cell lung cancer (NSCLC) and urothelial carcinoma, a type of bladder and urinary tract cancer. The drug will now be available to patients in India on the prescription of oncologists. The company believes that Tecentriq will play an important role in the treatment of people with advanced bladder cancer and metastatic non-small cell lung cancer in India. ]]> <![CDATA[Lupin’s Goa facility completes successful UK MHRA inspection]]> https://biospectrumindia.com/news/95/10719/lupins-goa-facility-completes-successful-uk-mhra-inspection.html https://biospectrumindia.com/news/95/10719/lupins-goa-facility-completes-successful-uk-mhra-inspection.html Wed, 04 Apr 2018 12:20:00 +0530 Pharma major Lupin Limited (Lupin) announced the successful completion of the inspection by the UK MHRA at its Goa facility in March, 2018. There were no critical or major observations in the inspection. Responding to the positive outcome, Nilesh Gupta, Managing Director, Lupin said: “We are committed to maintaining truly global quality standards at our manufacturing units. The successful inspection by UK MHRA is a meaningful development for our Goa plant”. For the financial year ended 31st March, 2017, Lupin’s consolidated sales and Net profit stood at Rs. 171,198 million (USD 2.55 billion) and Rs. 25,575 million (USD 381 million) respectively.                                                                                                                                                                                  ]]> <![CDATA[Slayback Pharma appoints Abhijit Mukherjee as Senior Advisor]]> https://biospectrumindia.com/news/95/10717/slayback-pharma-appoints-abhijit-mukherjee-as-senior-advisor.html https://biospectrumindia.com/news/95/10717/slayback-pharma-appoints-abhijit-mukherjee-as-senior-advisor.html Wed, 04 Apr 2018 10:55:00 +0530 Slayback Pharma is a privately held pharma research and development company, announced the appointment of Abhijit Mukherjee as a Senior Advisor to the Board and Management of Slayback, effective immediately. In this role, Abhijit will advise the company on strategic and operational matters. "There are very few leaders like Abhijit who have the rare ability of appreciating the smallest details while still maintaining a sharp understanding of the big picture. Abhijit's leadership experience in the pharmaceutical industry as well as his ability to connect the dots will be extremely valuable to the company. I am personally delighted to be working with him again,” said CEO Ajay Singh. Abhijit has a Bachelor of Technology in Chemical Engineering from the Indian Institute of Technology Kharagpur. He is a seasoned veteran in the pharmaceutical industry with a proven track record. For more than 15 years, Abhijit held a number of leadership roles at Dr. Reddy’s Laboratories Ltd, most recently serving as Chief Operating Officer leading operations of the company’s businesses globally. ]]> <![CDATA[East Bridge Capital buys 3.86% extra stake in Fortis]]> https://biospectrumindia.com/news/95/10714/east-bridge-capital-buys-3-86-extra-stake-in-fortis.html https://biospectrumindia.com/news/95/10714/east-bridge-capital-buys-3-86-extra-stake-in-fortis.html Tue, 03 Apr 2018 16:15:00 +0530 East Bridge Capital Master Fund has bought an additional 3.86 per cent stake in Fortis Healthcare for over Rs 256 crore through a market transaction. According to a regulatory filing, East Bridge Capital Master Fund, which held 5.87 per cent stake in Fortis Healthcare, increased its shareholding in the healthcare services provider to 9.73 per cent by buying 2 crore shares on March 28. Based on the weighted average price of the stock on March 28, at Rs 128.15 apiece, the transaction is estimated at Rs 256.30 crore.  Last week, Fortis Healthcare board had approved the demerger of its hospitals business, which will be acquired by Manipal Hospitals and TPG Capital, along with the sale of 20 per cent stake in its diagnostics chain SRL Ltd., in a Rs 3,900-crore deal. Manipal Hospitals, a part of Manipal Education and Medical Group (MEMG) has been backed by TPG, a leading global alternative asset firm and experienced healthcare investor since 2015. ]]> <![CDATA[Strides Shasun’s generic Ibuprofen receives USFDA approval ]]> https://biospectrumindia.com/news/95/10710/strides-shasuns-generic-ibuprofen-receives-usfda-approval-.html https://biospectrumindia.com/news/95/10710/strides-shasuns-generic-ibuprofen-receives-usfda-approval-.html Mon, 02 Apr 2018 17:00:00 +0530 Drug firm Strides Shasun has received approval from the US health regulator for generic Ibuprofen capsules, 200 mg, used for relieving pain. The company's wholly-owned subsidiary Strides Pharma Global has received approval for Ibuprofen capsules in the strength of 200 mg from the United States Food & Drug Administration (USFDA). The company's product is a generic version of Pfizer Inc's Advil Liqui-Gels 200 mg. "With a focus to secure its API supply chain for the product, the company under prior approval supplements filing will apply for a source change to Solara Active Pharma Sciences, a group company having a leading API franchise," Strides Shasun said. The product will be commercialised in Q4 of FY19 post completion of API source change process.The product will be manufactured at the company's oral dosage facility in Bangalore. The company has 74 cumulative abbreviated new drug application (ANDA) filings with USFDA of which 45 ANDAs have been approved as of date and 29 are pending approval. ]]> <![CDATA[Chrys Capital to buy 10% in Mankind for $350 M]]> https://biospectrumindia.com/news/95/10709/chrys-capital-to-buy-10-in-mankind-for-350-m.html https://biospectrumindia.com/news/95/10709/chrys-capital-to-buy-10-in-mankind-for-350-m.html Mon, 02 Apr 2018 15:45:00 +0530 India-bred private equity firm Chrys Capital is set to acquire 10 per cent in fast-growing Mankind Pharmaceuticals for $350 million. GIC of Singapore and CPPIB of Canada may co-invest in the deal, likely to be signed this week. This will mark Chrys Capital’s return to Mankind Pharma, a company it helped build  in 2015, it had sold 11 per cent stake in Mankind to another PE firm Capital International for $214 million, making a tenfold return in seven years. Chrys Capital, arguably the most successful investor in Indian pharma, came in late to pip global PE firms like Advent International and Carlyle who had made binding bids. Having worked with it, the promoters preferred Chrys Capital. Chrys Capital’s partner Sanjiv Kaul, a former Ranbaxy executive, has backed several pharmaceutical companies including Glenmark, Zydus, Intas, Torrent, GVK Pharma, Eris Life Sciences, among others. The deal may involve a secondary sale of shares by the promoter family, who currently hold 89 per cent stake in the company, said two people familiar with the deal. It’s not clear if Capital International will also partly divest its stake. Mankind Pharmaceuticals is India’s fifth largest drug company with domestic sales of Rs 500 billion and an EBITDA (earnings before interest depreciation and amortisation) of Rs 10 billion, which may go for an IPO next year. ]]> <![CDATA[MedGenome concludes the Study on Non-invasive Prenatal Testing]]> https://biospectrumindia.com/news/95/10707/medgenome-concludes-the-study-on-non-invasive-prenatal-testing.html https://biospectrumindia.com/news/95/10707/medgenome-concludes-the-study-on-non-invasive-prenatal-testing.html Mon, 02 Apr 2018 15:10:00 +0530 Genomics based diagnostics and research company, MedGenome along with ten other research collaborators conducted India’s first systematic study on Non-invasive prenatal screening test (NIPT). The study was conducted to analyse the performance of NIPT in Indian population at MedGenome’s CAP certified Bangalore Laboratory. The main objective was to evaluate the performance of NIPT for trisomies 21,18,13, X & Y chromosome abnormalities and triploidy in a cohort of pregnant women with intermediate to high risk on conventional screening. With a small blood sample taken from the mother’s arm, the NIPT screening test analyses cell free DNA of the fetus to detect chromosomal abnormalities. The screening test is safe and non-invasive. With a detection rate of over 99% and a false positive rate of less than 0.03 % the screening test is highly accurate. In situations where NIPT has been implemented, a significant reduction of 50-70% in invasive procedures has been observed. In the study, NIPT screening was performed on 516 pregnancies, who had tested intermediate to high risk on conventional screening test (Double marker, Quadruple marker test) in the first and second trimester. The results were confirmed through invasive testing or clinical examination post birth. Over 98% were reported low risk and 2% tested high risk on NIPT for the conditions tested. The test showed that an abnormality detected by NIPT was much more likely to be actually present and therefore authenticating that NIPT test was much more likely to truly detect abnormalities as compared to conventional screening (Double Marker test, Quadruple marker test) It is remarkable to note that those considered intermediate to high risk pregnancies through conventional screening were found to be low risk with NIPT. Meaning, a large number (98.2%) of the women could potentially avoid invasive procedures such as amniocentesis which cause emotional anxiety and come with a small risk of miscarriage. Dr. Priya Kadam, Program Director- NIPT, MedGenome, emphasizing the importance of non-invasive screening process said, “NIPT is not gestation age specific and can be offered to all pregnant women to be assured of their baby’s health. Also, due to high accuracy, safety and low false positive rate NIPT is a viable option for any pregnant woman and can be performed from as early as the 9th week of a pregnancy.” She further added, “NIPT is a revolutionary test and with increased awareness and adoption  this test can help significantly reduce our country’s genetic disorder burden. Currently, NIPT may be used in cases with high-risk results on conventional screening to avoid unnecessary invasive tests. Further reduction in cost and greater awareness would provide the beneﬁts of this. The leading hospitals and institutes participated in the study were: Sir Ganga Ram Hospital, New Delhi, Rainbow Hospital, Hyderabad, Amrita Institute of Medical Sciences and Research Center, Kochi, Sri Ramchandra Medical College, Chennai, All India Institute of Medical Sciences, New Delhi, Post graduate institute and Medical Research Center, Chandigarh, Jawaharlal Nehru Institute of Post graduate Medical Education and Research, Pondicherry, CIMAR Fertility Center, Kochi, Manipal Hospital, Bengaluru, Indraprastha Apollo Hospital, New Delhi.   ]]> <![CDATA[Dr Reddy's, Promius Pharma file NDA for DFN-02 to treat migraine ]]> https://biospectrumindia.com/news/95/10708/dr-reddys-promius-pharma-file-nda-for-dfn-02-to-treat-migraine-.html https://biospectrumindia.com/news/95/10708/dr-reddys-promius-pharma-file-nda-for-dfn-02-to-treat-migraine-.html Mon, 02 Apr 2018 15:10:00 +0530 Dr Reddy's Laboratories Ltd and its subsidiary, Promius Pharma, LLC have announced the filing of New Drug Application (NDA) for its migraine candidate DFN-02 with the U.S. Food and Drug Administration (USFDA). According to Dr. Anil Namboodiripad, Senior Vice President, Proprietary Products and President, Promius Pharma, the NDA for DFN-02 is an important step forward in the company’s mission to bring solutions that address unmet needs. "The filing of DFN-02 NDA represents our continuing commitment to bring innovative solutions in migraine treatment," Namboodiripad said. "Acute migraine attacks are typically associated with pain and symptoms, such as nausea, photophobia, and phonophobia. It is important that an effective migraine treatment helps address associated symptoms. Equally important is having a well-tolerated treatment that provides patients a satisfactory resolution of their migraine attack," he added. In a multicentre, double-blind, randomised, placebo controlled study with 107 subjects, DFN-02 has demonstrated that it can effectively treat pain and associated symptoms during a migraine attack, the Hyderabad-based Dr Reddy's claimed in a statement. Upon approval, the product will be commercialised by Promius Pharma. ]]> <![CDATA[Lupin’s Pithampur Unit gets clearence by Health Canada]]> https://biospectrumindia.com/news/95/10704/lupins-pithampur-unit-gets-clearence-by-health-canada.html https://biospectrumindia.com/news/95/10704/lupins-pithampur-unit-gets-clearence-by-health-canada.html Mon, 02 Apr 2018 11:30:00 +0530 Pharma major Lupin Limited (Lupin) has announced the successful facility review carried out by Health Canada for its Pithampur Unit 2 (Indore) manufacturing facility. Following the review, Health Canada has maintained the compliant rating for Unit 2 at Pithampur (Indore) and has issued a revised ‘Establishment License’. Commenting on the development, Nilesh Gupta, Managing Director, Lupin said: “Lupin is committed to maintaining truly global quality standards at our manufacturing units. The successful review by Health Canada is a significant milestone in that journey for Pithampur Unit 2 (Indore).” For the financial year ended 31st March, 2017, Lupin’s consolidated sales and Net profit stood at Rs. 171,198 million (USD 2.55 billion) and Rs. 25,575 million (USD 381 million) respectively. ]]> <![CDATA[Apollo Pharmacy opens 3000th outlet]]> https://biospectrumindia.com/news/95/10703/apollo-pharmacy-opens-3000th-outlet.html https://biospectrumindia.com/news/95/10703/apollo-pharmacy-opens-3000th-outlet.html Mon, 02 Apr 2018 11:20:00 +0530 Apollo Pharmacy recently commissioned its 3000th retail unit at Seevaram, Thuraipakkam. Apollo Pharmacy was started in 1987 with the single-minded goal of ensuring consumers were protected from spurious drugs and had round-the-clock access to genuine life-saving and OTC drugs. It is today India’s largest retail pharmacy chain with a presence in 18 states across India covering over 400 cities and dispenses over 3.5 Lakh prescriptions per day. Chairman & Founder Dr. Prathap C. Reddy’s message on this occasion, “I am very pleased that the movement against spurious drugs that we started in 1987 with a single store has today blossomed into a countrywide presence.  Apollo Pharmacy has always upheld Apollo’s patient first philosophy and consumers can depend on us to always safeguard them when it matters most. We greatly value the trust that has been placed in us and as clinicians we appreciate the role pharmaceuticals play in the healthcare value chain.”  Speaking on the occasion, Shobana Kamineni, Joint Vice-Chairman Apollo Hospitals said, “Apollo Pharmacy is not just Asia’s first and largest branded pharmacy network, but it has pioneered value-added services like free home delivery, refill reminder programs and community health camps. She added that this milestone had been possible because of the trust customers have reposed in Apollo pharmacy and the commitment and hard work of its 19,000 dedicated employees who serve 3,50,000 customers per day in over 400 cities and towns in 18 states.” Apollo pharmacy has conceptualized new format stores with a focus on providing the latest therapies against NCD’s cognizant of the huge burden it places on public health and the nation’s economy. In the days to come Apollo pharmacy is looking to introduce several programs for chronic care and preventive care. This year, Apollo Pharmacy also introduced Holland & Barrett, UK. ]]> <![CDATA[AstraZeneca’s Lokelma receives EU approval]]> https://biospectrumindia.com/news/95/10699/astrazenecas-lokelma-receives-eu-approval.html https://biospectrumindia.com/news/95/10699/astrazenecas-lokelma-receives-eu-approval.html Fri, 30 Mar 2018 14:45:00 +0530 AstraZeneca is a global, science-led biopharmaceutical company, announced that the European Commission has granted marketing authorisation for Lokelma (formerly ZS-9, sodium zirconium cyclosilicate) for the treatment of adults with hyperkalaemia. Hyperkalaemia is a serious condition characterised by elevated potassium levels in the blood associated with cardiovascular, renal and metabolic diseases. Lokelma is a highly-selective, oral potassium-removing agent. The approval is supported by data from three double-blind, placebo-controlled trials and one open-label trial, where patients with hyperkalaemia were treated for up to 12 months. In these trials, for patients receiving Lokelma the median time to achieving normal potassium levels in the blood was 2.2 hours, with 98% achieving normal levels within 48 hours from baseline. Lokelma also demonstrated sustained potassium control for up to one year. Elisabeth Björk, Vice President, Head of Cardiovascular, Renal and Metabolism, Global Medicines Development, AstraZeneca, said: “The consequences of hyperkalaemia can be serious, even life-threatening, and can occur in patients either with chronic kidney disease or as a result of taking some medications for heart failure. Today’s approval of Lokelmaaddresses a significant unmet need by bringing a rapid and sustained therapeutic option for patients with hyperkalaemia.” Lokelma is currently under separate regulatory review in the US, with a decision expected in the first half of 2018. ]]> <![CDATA[“We keep quality at the forefront of everything that we do”]]> https://biospectrumindia.com/interviews/95/10698/we-keep-quality-at-the-forefront-of-everything-that-we-do.html https://biospectrumindia.com/interviews/95/10698/we-keep-quality-at-the-forefront-of-everything-that-we-do.html Fri, 30 Mar 2018 12:30:00 +0530 In an interaction with BioSpectum Peter DeYoung, the CEO of Piramal Critical Care, who is a member of the Piramal Pharma Operating Board and a member of the Board of Piramal Imaging SA shared his views about the company’s expansion plans and maintaining compliance to US FDA rules.   Piramal Critical Care is the world’s 3rd largest producer of inhaled anesthetics, what plans you have to reach the no 1 position? We are the world’s third largest producer of Inhaled Anaesthetics with a global market share of 10 per cent and the only company with the complete inhalation anaesthetic product portfolio, but we have a long way to go before we could contemplate a number one position. We are also a leader in intrathecal spasticity products. Our products are sold directly or through our network of distribution partners in over 110 countries across the world, with widespread availability in the US, Europe, Japan and a number of important Emerging Markets, including India. Piramal Critical Care follows a strategy that is a combination of both organic and inorganic growth. We aim to build on our strength in the hospital and institutional segment by further augmenting our generic hospital pharmaceutical product portfolio and by increasing the market share of our current products. In order to ensure the long-term sustainability of our business, we are pursuing profitable growth in our inhalation anesthetics business and our hospital portfolio overall. With that in mind, while we believe we have headroom to increase volume and market share with each of our current offerings, it also needs to be done in the context of profitability. Thus we are pursuing a balanced strategy of profitable market share growth coupled with efforts to broaden our basket of offerings to further increase our relevance to our customers. After acquiring drugs from Mallinckrodt and Janssen, are you planning any other acquisition or are you in any talks? As a company we have a long history of pursuing both organic and in-organic avenues in parallel to driving profitable growth. However, given the size and importance of the transactions, one of our main focus areas over the last year has been to successfully integrate the products that we acquired from Janssen in October 2016 and Mallinckrodt in March 2017. Now that we have made substantial progress in these important segments, we are once again looking at organic as well as inorganic growth opportunities. In the coming years, we foresee a number of exciting growth opportunities for Piramal Critical Care. As mentioned earlier, with less than 10 per cent global market share in inhalation anaesthesia niche, we are yet to maximise our full potential of these products. To accelerate growth, we have some regionally important product enhancements underway for our lead inhalation anaesthetic product, Sevoflurane, and we also plan to launch Desflurane. In addition, as we continue to transition, integrate, and gain experience with the products that we acquired from Janssen and Mallinckrodt, we believe that there is potential to grow these franchises. Further, as one of the few independent pharmaceutical companies with commercial capabilities dedicated to the hospital channel, we plan on marketing products that are developed or made by partners that lack effective commercial front-ends, particularly in the US and Europe.   You have a strong presence in countries like US and Europe. Are there any further expansion plans? Our products are currently sold in 110 countries, either directly or through our local partners. We currently have direct capabilities in the US as well as a number of countries in Europe and work through partners in the rest of the world. Our primary focus for expansion is to add compelling hospital pharmaceutical products to our portfolio. With respect to our in-country presence, we periodically evaluate our go-to-market strategy in each country to determine the most effective way forward. While it makes sense in some countries such as the US, UK, Italy, or Germany, to have our own commercial capabilities, in a number of other countries we are better served with a local marketing partner. Our decision to work directly in a market is based on our understanding of the market size and attractiveness, our product portfolio and pipeline for that market, the local partner ecosystem, and our ability to do business in that market.   How do you ensure adherence to global standards/ what steps do you take to ensure compliance to US FDA rules? Our products are used in a challenging and unforgiving environment – i.e. operating theatres in hospitals. Providing our customers with reliable, uninterrupted, high quality supply coupled with responsive customer service, are essential differentiators in a market where our customers frequently suffer from product shortages, due to quality issues. We are able to meet these product expectations through our established network of internal manufacturing capabilities and external supply partners in the US, Europe and India. Our commitment to quality resonates through stringent global regulatory approvals that are accredited to our manufacturing network. We keep quality at the forefront of everything that we do. We start with accountability: quality is in everyone’s Key Results Area, including mine, and not just those of the quality department. In addition to our dedicated business and site-specific quality teams, the corporate quality team has developed a number of tools and processes that are applied across Piramal pharmaceutical businesses, including Piramal Critical Care. For example, we look to learn from others. The quality team examines citations given to our competitors and when they both conduct scheduled and unscheduled internal peer audits of Piramal manufacturing sites, they look for gaps versus current or emerging expectations. Finally the Quality team reports independently from the business team, up to the Piramal Enterprises Board, ensuring that it is empowered to enable balanced decisions. Across the company, not just limited to Piramal Critical Care, Piramal has maintained a clean slate over a long period of time. We are glad to report that in 2017, 28 regulatory agency inspections were conducted, including five US FDA audits across plant locations, including Piramal Critical Care sites, with all of the audits being cleared successfully without a single day of production stoppage. What trends do you see in the industry in coming year? As we experienced last year, our customers remain under intense pressure to manage healthcare costs and they do have alternatives given we operate in the generics segment. We expect this to continue in 2018. This drives us to constantly ensure and demonstrate that we provide value to our customers. So in addition to reliable, high quality supply and excellent service, competitive pricing is a crucial factor to increase both market share and volumes for our existing products. Keeping these trends in mind, within the global generics market, our product portfolio is focused on generic hospital pharmaceutical products that have complexities around manufacturing, sales or distribution. In markets where it is relevant, many of our offerings are branded, including the products recently acquired from Janssen and Mallinckrodt. These attributes make for comparatively attractive niches vis-à-vis other generic products. As we look at line extensions and new product additions, we hope to replicate our track record in selecting attractive niches while meeting our customer’s needs. ]]> <![CDATA[Godrej Interio’s office wellness portfolio to expand offering in Pune]]> https://biospectrumindia.com/news/95/10696/godrej-interios-office-wellness-portfolio-to-expand-offering-in-pune.html https://biospectrumindia.com/news/95/10696/godrej-interios-office-wellness-portfolio-to-expand-offering-in-pune.html Fri, 30 Mar 2018 11:00:00 +0530 Godrej Interio, India’s leading furniture brand in institutional segments with a strong commitment to sustainability and centers of excellence in design, manufacturing and retail launched an exclusive product ‘Motion Chair’ in Pune. The product was launched by Mr. Anil Mathur, Chief Operating Officer, Interio Division. Aided by this innovative product, the retail brand aims to spearhead and play a significant role in growth across Pune’s health and wellness category. Office workers today spend many more hours at work. Furthermore, most of these hours in office are spent working on the computer or laptop. Remaining seated at the workstation for extended periods force the modern office worker to sit in highly strained postures for longer duration which lead to irreversible spine damage over time.  Therefore this innovative product will be a boon for such individuals. Anil Mathur, Chief Operating Officer, Interio Division said, “The rising popularity of health and wellness products has enhanced demand for new-age office furniture. This huge untapped opportunity spurred us to invest 20 Cr in health and wellness category furniture manufacturing.” Godrej Interio has a wide office product range in wellness portfolio meeting different various needs and tastes based on Wellness Insights. ‘Motion Chair’ is based on a unique concept where the product is responsive to the natural postural change needs of the user and enables active sitting and dynamic body movements for overall wellness and efficiency of the user. ]]> <![CDATA[Merck to launch three new products at INTERPHEX 2018]]> https://biospectrumindia.com/news/95/10691/merck-to-launch-three-new-products-at-interphex-2018.html https://biospectrumindia.com/news/95/10691/merck-to-launch-three-new-products-at-interphex-2018.html Thu, 29 Mar 2018 18:00:00 +0530 Merck, a leading science and technology company, will introduce three new products for the flexible manufacturing of biologics at INTERPHEX, April 17-19, in New York City, USA. Pellicon® Capsule with Ultracel® Membrane. This first-of-its-kind single-use tangential flow filtration device is used for bioprocessing of antibody-drug conjugates and monoclonal antibodies. Millipak® Final Fill Filter. These filters provide maximum product yield in high-value, small-volume processing. Mobius® Power MIX 2,500-Liter and 3,000-Liter large-scale single-use mixers. These mixing systems combine high-performance technology with design elements that make them easy to use when mixing the most challenging buffers, media and biopharmaceutical ingredients. Attendees are invited to learn more about how Merck is innovating flexible manufacturing to save customer’s time and money. Merck experts will share best practices and insights across a variety of pharmaceutical manufacturing topics at the various presentations and panel discussions. ]]> <![CDATA[GSK Consumer Healthcare organises TB awareness rally]]> https://biospectrumindia.com/news/95/10687/gsk-consumer-healthcare-organises-tb-awareness-rally.html https://biospectrumindia.com/news/95/10687/gsk-consumer-healthcare-organises-tb-awareness-rally.html Thu, 29 Mar 2018 14:30:00 +0530 GSK Consumer Healthcare’s Sonepat Unit and its NGO partner Sakshi organised a Tuberculosis (TB) awareness rally in Khewra Gaon in Sonipat on the occasion of World Tuberculosis (TB) Day. As a part of its Corporate Social Responsibility initiative- Mission Health, GSK supported the awareness drive. Dr Mahender Singh, MD Community Medicine- Civil surgeon (Retd.) addressed and took part in the rally. The theme for this year was “Wanted: Leaders for a TB-free world”. Along with various awareness initiative a rally was organised with an aim to help in building commitment to bring an end to TB. The event witnessed participation of over 140 local residents including children, women, anganwadi workers and other community members who carried plaque cards to create awareness around TB. Informative education and communication material were also distributed towards the end. ]]> <![CDATA[Piramal Pharma Solutions emerges as a winner]]> https://biospectrumindia.com/news/95/10686/piramal-pharma-solutions-emerges-as-a-winner.html https://biospectrumindia.com/news/95/10686/piramal-pharma-solutions-emerges-as-a-winner.html Thu, 29 Mar 2018 13:55:00 +0530 Piramal Pharma Solutions (PPS) has been recognized as a winner at the CMO Leadership Award 2018 in six categories. The event was held on March 21st, 2018 in New York during the Drug, Chemical and Associated Technologies Association (DCAT) week. Piramal was recognized across all six categories - Capabilities, Compatibility, Expertise, Quality, Reliability, and Service. Vivek Sharma, Chief Executive Officer at Piramal Pharma Solutions, said, "We are delighted to be recognized again at the CMO Leadership Awards, this is the sixth consecutive year that we have won. To be one of the few service providers to be recognized in all six categories is humbling, and I would like to congratulate the entire PPS team for their efforts. I also want to thank our customers for their continued trust in us, as we seek to serve the needs of the end patients." Vivek Sharma added, "Piramal Pharma Solutions continues to make significant strides as we build around the pillars of Customer Centricity, Innovation, and Quality, with an emphasis on scientific excellence. We are focused on investing in our customers' future needs, and be the 'integrated partner of choice' for pharma and biotech organizations, world-wide." ]]> <![CDATA[Lupin receives FDA approval for generic Clobex Spray, 0.05%]]> https://biospectrumindia.com/news/95/10683/lupin-receives-fda-approval-for-generic-clobex-spray-0-05.html https://biospectrumindia.com/news/95/10683/lupin-receives-fda-approval-for-generic-clobex-spray-0-05.html Thu, 29 Mar 2018 10:25:00 +0530 Pharma major Lupin announced that it has received final approval for its Clobetasol Propionate Spray, 0.05% from the United States Food and Drug Administration (FDA) to market a generic version of Galderma Laboratories, L.P.’s Clobex® Spray, 0.05%. Lupin’s Clobetasol Propionate Spray, 0.05% is the generic equivalent of Galderma Laboratories, L.P.’s Clobex® Spray, 0.05%. It is indicated for the treatment of moderate to severe plaque psoriasis affecting up to 20% body surface area (BSA) in patients 18 years of age or older. Clobetasol Propionate Spray, 0.05% had annual sales of approximately USD 30.5 million in the US (IQVIA MAT January 2018). ]]> <![CDATA[Biocon gets European nod for its insulin to market globally]]> https://biospectrumindia.com/news/95/10682/biocon-gets-european-nod-for-its-insulin-to-market-globally.html https://biospectrumindia.com/news/95/10682/biocon-gets-european-nod-for-its-insulin-to-market-globally.html Wed, 28 Mar 2018 15:05:00 +0530 Indian biotech major Biocon said that the biosimilar insulin glargine co-developed with US drug major partner Mylan received approval from the European Commission and the Australian regulatory body for marketing it globally. The Australian regulatory body Therapeutic Goods Administration (TGA) also approved the insulin in a pre-filled pen for diabetics in that country. The Pennsylvania headquartered Mylan is an American global generic and specialty pharma firm registered in the Netherlands, with a presence at Hatfield in Britain's Hertfordshire county. "The approval of EC and TGA are a milestone in our collaboration as it furthers our mission to provide a quality and affordable insulin analog for the people with diabetes globally," Biocon Chief Executive Arun Chandavarkar said on the occasion. As a global insulin player, Biocon addresses healthcare challenges associated with diabetes by investing in research and development and manufacturing to build scale and make the drug affordable in many markets. The EC approval applies to all 28 European Union member states and the European Economic Area member states of Norway, Iceland and Liechtenstein. ]]> <![CDATA[Lumenis brings technology for Skin Pigmentation ]]> https://biospectrumindia.com/news/95/10680/lumenis-brings-technology-for-skin-pigmentation-.html https://biospectrumindia.com/news/95/10680/lumenis-brings-technology-for-skin-pigmentation-.html Wed, 28 Mar 2018 14:00:00 +0530 Change in the lifestyle and changing latest trends have increased the demand for tattoo removals and skin rejuvenation especially among youngsters in the recent times. To address this challenge, Lumenis India have launched a technology ‘Naturalase QS’ for the first time in India. Naturalase QS’ is new advanced highest energy Q-switched system in the world and is used for skin pigmentation & tattoo removal.  ‘Naturalase QS’ can successfully treat skin rejuvenation, tattoo removal (all colors), pigmented lesions, vascular lesions and hair removal with more energy and a better beam giving more accurate and better results. The technology has been launched for the first time in India which is currently installed in Dr P.N Behl Skin Institute & School of Dermatology Hospital in New Delhi. While the other laser treatments uses small spot sizes with high energy, which results in scarring and skin pigmentation changes, Naturalase QS offered deep penetration of the laser beam into the skin yet provide better protection to the top layer of the skin. Dharmendra Mistry, Lumenis India & South Asia Country Head said “With the launch of Naturalase QS in India, there is an opportunity for those who regret their ink. People who wish to join armed forces due to strict job codes faces lot of problems to get removal of tattoos. Resultant to that many government & army hospitals could not easily address the tattoo removal cases. We are happy to announce the new innovative effective technology for the first time in India which will benefit all our stakeholders. Naturalase QS uses high energy levels, short pulse durations and wide treatments, which is more effective, quicker, safe and most comfortable treatments with better results and higher customer satisfaction, The high energy, nano quick laser pulse reaches deep into the skin where it shatters the natural or ink pigments into particles small enough to be cleared by the body’s lymphatic system” Dr Vikas Kapoor, Skin Institute & School of Dermatology, Senior Consultant said “Skin Institute is the first in the country to acquire Naturalase (Q-Switch laser). It is safe, effective, long lasting treatment for all skin problems. Naturalase is the latest technology to treat uneven skin tone, hyperpigmentation, freckles, tattoos and birth marks. This revolutionary service is a boon to dermatology. Naturalase is a powerful high energy Q-Switch laser. Confident of the results, The Skin Institute assures and offers the best at affordable prices.” Dr Poonam Sharma, Skin Institute & School of Dermatology, Senior Consultant said “Naturalase QS is an effective treatment for tattoos removal, Nevus of OTA & laser toning. There is 10-15% improvement in skin tone and visible lightening of pigmentation with each sitting. There is less downtime with the laser which adds to the patient satisfaction.” Naturalase QS technology is also known as giant pulse formation, which is a technique in which a laser is made to produce a pulsed beam. Naturalase QS offers four different wavelengths to effectively deal with a wide range of tattoo colors, on a wide range of skin types. Its four wavelengths- 1064nm, 532nm, 650nm & 585nm- target nine of the most frequently used tattoo colors ranging from light orange to dark black.   ]]> <![CDATA[Mylan, Biocon receive EC approval for Semglee]]> https://biospectrumindia.com/news/95/10673/mylan-biocon-receive-ec-approval-for-semglee.html https://biospectrumindia.com/news/95/10673/mylan-biocon-receive-ec-approval-for-semglee.html Wed, 28 Mar 2018 10:55:00 +0530 Mylan N.V., one of the world’s leading pharmaceutical companies, and Biocon Ltd., Asia’s premier biopharmaceutical company, have announced that their co-developed biosimilar insulin glargine Semglee™ has received marketing authorization approval from the European Commission following the positive recommendation by the Committee for Medicinal Products for Human Use (CHMP) of European Medicines Agency. Semglee™ 100 units/mL 3 mL prefilled disposable pen for people with diabetes, is the first biosimilar from Biocon and Mylan’s joint portfolio to be approved in Europe. Additionally, the Therapeutic Goods Administration (TGA), Australia has also approved biosimilar insulin glargine Semglee™ 100 IU/mL 3 mL prefilled pen for the people with diabetes in Australia. Mylan President Rajiv Malik said, “We are excited to be able to bring Mylan and Biocon’s biosimilar insulin glargine to Europe and Australia where millions of people are currently living with diabetes, and we are committed to continuing to bring high quality, more affordable biosimilar products to markets around the world. The investments that we have made to develop and manufacture a leading portfolio of complex products, including Semglee™, is one way that we are delivering on our commitment to expand access to high quality medicine.” Dr. Arun Chandavarkar, CEO and Joint Managing Director, Biocon, said, "The approval of  Mylan and Biocon’s biosimilar insulin glargine by the European Commission and TGA Australia are important milestones in our collaboration. It furthers our mission to provide a high quality, affordable insulin analog for people with diabetes globally. As a credible, global insulins player, we are committed to address the growing healthcare challenges associated with diabetes and have made significant investments in R&D and manufacturing to build scale and make our affordable insulins portfolio available in many markets.” The EC approval of Semglee™ applies to all 28 European Union (EU) member states and the European Economic Area (EEA) member states of Norway, Iceland and Liechtenstein. In addition to  these approvals  marketing applications for Semglee™ have also been submitted in Canada and the U.S. Several submissions are planned for key Emerging Markets. Diabetes is the fastest growing chronic condition in the world and the prevalence of this disease is increasing among all ages. In Europe the number of diabetics are expected to grow to 38 million by 2030, while in Australia it currently affects nearly two million* people. Mylan plans to launch Semglee™ in Australia later this year and expects to begin launching the product across various markets in Europe in the second half of 2018.  ]]> <![CDATA[Indian Immunologicals launches VAXTAR 5]]> https://biospectrumindia.com/news/95/10671/indian-immunologicals-launches-vaxtar-5.html https://biospectrumindia.com/news/95/10671/indian-immunologicals-launches-vaxtar-5.html Tue, 27 Mar 2018 15:40:00 +0530 Indian Immunologicals Limited has launched VAXTAR 5, Pentavalent vaccine for the children. IIL is all set to make this vaccine in its state-of-the-art vaccine manufacturing facility in Hyderabad for retail market and for the national “Universal Immunisation Programme” (UIP) implemented by Ministry of Health and Family Welfare (MOHFW), Government of India. Indian Immunologicals Limited (IIL) is a wholly owned subsidiary of the National Dairy Development Board (NDDB). IIL is one of the leading human vaccine manufacturer, producing several vaccines for adults and children VAXTAR 5 (Pentavalent vaccine with Diptheria, Pertussis, Tetanus, Hepatitis B and HiB) is available in single dose and multidose presentations. The vaccine was developed indigenously using IIL’s R&D expertise and has been tested in multiple centres under prescribed government guidelines. IIL leverages its strength in manufacturing and quality assurance system to produce a highly effective and moderately priced vaccine. Ministry of Health and Family Welfare (MOHFW) introduced Pentavalent vaccine four years ago and are in the process of scaling up use of Pentavalent vaccine across the country. MOHFW procures about 85 to 90 million doses of Pentavalent vaccine annually. Dr. K Anand Kumar, Managing Director, Indian Immunulogicals Limited said, “In the recent tender floated by the Ministry of Health for Pentavalent vaccine, IIL has emerged as the most competitive bidder. With IIL’s entry into the Pentavalent market, there will be significant savings to the exchequer.” IIL launched several other human vaccines over the past decade and has been successfully supplying its Hepatitis B, DPT (Triple Antigen) and TT (Tetanus Toxoid) vaccines to the UIP programme. IIL is also actively pursuing work on hexavalent vaccine which includes inactivated polio antigen.     ]]> <![CDATA[SMT, Cardinal Health collaborate for the Indian market]]> https://biospectrumindia.com/news/95/10670/smt-cardinal-health-collaborate-for-the-indian-market.html https://biospectrumindia.com/news/95/10670/smt-cardinal-health-collaborate-for-the-indian-market.html Tue, 27 Mar 2018 15:05:00 +0530 SMT (Sahajanand Medical Technologies), the leading manufacturer of cardiac stents in India, announces a strategic partnership with Cordis, Cardinal Health’s interventional vascular business.  The new partnership with SMT in India will provide Cardinal Health access to the fast-growing Indian cardiology market, as the latter marks its entry into the Indian market. SMT has a strong and established sales and direct distribution network across India including Tier II & III cities. Through this partnership, the Cordis range of products would be made available to patients across the country. Collaboration between Cardinal Health and SMT will address the high disease burden of cardiac mortality and hospitalizations in India, by providing global quality cardiology and endovascular solutions to hospitals and patients. The new partnership with Cardinal Health will provide best in class products in cardio access, endo-access, cardiac guide catheter and PTCA balloons segment. SMT will take up this basket of quality products to the fast-growing Indian cardiology market with a strong and established sales and direct distribution network across India including Tier II & III cities. This will help Indian patients to have access to world class products in cardiovascular segment. Through this partnership, Cardinal Health will be able to build reliable and efficient channels to reach deep into the Indian market for Cordis products. ]]> <![CDATA[USV forays into German market ]]> https://biospectrumindia.com/news/95/10669/usv-forays-into-german-market-.html https://biospectrumindia.com/news/95/10669/usv-forays-into-german-market-.html Tue, 27 Mar 2018 13:40:00 +0530 Mumbai based pharma company, USV Pvt. Ltd enters the highly competitive German drug market by acquiring Juta Pharma GmbH. Germany is home to Europe’s largest and the world’s fourth largest pharmaceuticals market. It is a highly attractive R&D location ranked first in Europe and second in the world, with respect to clinical trials. According to market intelligence firm, the volume of generic drugs in Germany is expected to reach USD 9.5 bn by end 2021. Leena Gandhi Tewari, Chairperson, USV Pvt. Ltd. said, "This is a positive move to have a presence in the German market and also the tender business. We are excited with the synergies and the opportunities that come from the acquisition of Juta Pharma GmbH. The strong work culture possessed by both the organisations will enable business growth in Germany and the strategic pursuit in the European market.” USV is relying on US and Europe markets as key drivers of its export revenues, having overcome the remediation hurdles for its Daman manufacturing facility. On the acquisition, Prashant Tewari, M.D., USV Pvt. Ltd. said, “Germany’s drug market is a highly competitive market. Acquisition of Juta Pharma GmbH enables launch of a basket of products with greater speed and also the direct participation in the tender market. The generic volume share is much higher in Germany compared to many other European countries. We expect the business to grow to USD 25 million in next five years.” Torben Laursen, M.D., Juta Pharma GmbH said, “We are very pleased to have found an organisation with similar values, beliefs and business goals. We really appreciate having joined the USV family and look forward to leveraging the strengths of the combined organization.”     ]]> <![CDATA[Syngene inks drug discovery agreement with GSK]]> https://biospectrumindia.com/news/95/10667/syngene-inks-drug-discovery-agreement-with-gsk.html https://biospectrumindia.com/news/95/10667/syngene-inks-drug-discovery-agreement-with-gsk.html Tue, 27 Mar 2018 12:40:00 +0530 Biocon's contract research arm Syngene International inked a drug discovery agreement with global drug firm GSK. The multi-year R&D agreement between the two companies will focus on accelerating the discovery of new drug candidates using Syngene's discovery services platforms. As part of the collaboration, Syngene will set-up a customised discovery research laboratory to support projects across several therapeutic areas.  A team of Syngene scientists will work closely with GSK's global R&D teams on discovery research projects to identify new drug candidates with the potential to address some of the world's most pressing healthcare needs. Syngene started offering discovery services to global R&D focused organisations from 1994 onwards. Over the years, it has consolidated its position in offering integrated discovery, development and manufacturing services across small and large molecules within both the pharmaceutical and biotechnology industries. ]]> <![CDATA[Lupin brings generic Lodosyn tablets to US market for Parkinson's]]> https://biospectrumindia.com/news/95/10666/lupin-brings-generic-lodosyn-tablets-to-us-market-for-parkinsons.html https://biospectrumindia.com/news/95/10666/lupin-brings-generic-lodosyn-tablets-to-us-market-for-parkinsons.html Tue, 27 Mar 2018 12:15:00 +0530 Drug firm Lupin launched its Carbidopa tablets, used for the treatment of symptoms of Parkinson's disease and Parkinsonism, in the American market. The company has launched the product in the strength of 25 mg after approval from the United States Food and Drug Administration (USFDA). The product is the generic version of Aton Pharma Inc's Lodosyn tablets in the same strength. The tablets are indicated for use "with Carbidopa-Levodopa or with Levodopa in the treatment of the symptoms of idiopathic Parkinson's disease, postencephalitic parkinsonism, and symptomatic parkinsonism, which may follow injury to the nervous system by carbon monoxide intoxication and/or manganese intoxication," Company stated. As per IQVIA MAT January 2018 data, Carbidopa tablets, 25 mg, had annual sales of approximately $17.4 million in the US. ]]> <![CDATA[Thermo Fisher’s MR-proADM to address sepsis treatment]]> https://biospectrumindia.com/news/95/10658/thermo-fishers-mr-proadm-to-address-sepsis-treatment.html https://biospectrumindia.com/news/95/10658/thermo-fishers-mr-proadm-to-address-sepsis-treatment.html Mon, 26 Mar 2018 15:40:00 +0530 A new analysis of 1089 patients with sepsis and septic shock across 33 German Intensive Care Units was recently published in Critical Care by SepNet Critical Care Trials Group in collaboration with Thermo Fisher. The biomarker, mid-regional proadrenomedullin (MR-proADM), was found to add significant clinical value in identifying the likelihood of further disease progression, the earlier escalation of therapy in patients at risk of treatment failure, and the subsequent de-escalation of treatment and early discharge of low risk patients. Increased levels of Adrenomedullin (ADM) are generated in disease conditions in order to stabilize the microcirculation and protect against vascular permeability. However, the reliable measurement of ADM is complicated by its short half-life and rapid degradation. The stable fragment of the peptide, MR-proADM, allows the accurate quantification of incremental changes over the course of therapy. Recent evidence highlights the use of MR-proADM as a highly sensitive biomarker to assess disease severity in patients with sepsis with concentrations rapidly induced in the initial stages of sepsis development following burns and neurological disorders, as well as in response to invasive fungal infections in septic shock patients.   ]]> <![CDATA[Public Perception towards Mental Health in India]]> https://biospectrumindia.com/news/95/10657/public-perception-towards-mental-health-in-india.html https://biospectrumindia.com/news/95/10657/public-perception-towards-mental-health-in-india.html Mon, 26 Mar 2018 14:40:00 +0530  ‘How India Perceives Mental Health,’ a report published by The Live Love Laugh Foundation (TLLLF) to gauge the public perception of mental health across 8 Indian cities has revealed that 87% of respondents associate mental illness with severe disorders (like schizophrenia and Obsessive Compulsive Disorder) and their symptoms. Illustrating the poor understanding of the broad spectrum of mental illness, respondents were unlikely to associate mental illness with symptoms of more common mental disorders such as anxiety, when describing people with mental illness. The survey also revealed high prevalence of stigma with 47% of people using the word “retard” to describe people with mental illness. Further, 60% of respondents believe that people with mental illness “should have their own groups to avoid contaminating healthy people” and 68% believe that they “should not be given any responsibility.”60% believe that mental illness is caused by a “lack of self-discipline and willpower”. The study has revealed three broad segments of people based on their attitudes towards mental illness: Segment 1 (27%) - Those who indicate support for people perceived as having mental illness. They would not discriminate against people with mental illness and predominantly believe that anyone can suffer from mental illness. This segment was seen predominantly in cities such as Kanpur, Patna and Delhi; Segment 2 (47%) - Those who are judgmental against people perceived as having a mental illness. This segment includes people who are more aware of mental illnesses and associated symptoms, but also display some stigma against people with mental illness. While the individuals in this segment sympathise with people with mental illness, they themselves would like to keep a safe distance. This segment was seen predominantly in Mumbai, Hyderabad and Kolkata; Segment 3 (26%): This group comprises individuals who display fear towards people perceived as having mental illness. This segment are “frightened of living in the same neighbourhood as and interacting with someone suffering from mental illness”. Bangalore and Pune were seen to have a larger representation from this segment. The findings illustrate the often ignored, but, critical role of stigma-reduction programmes in addressing mental health. TLLLF 2018 National Survey Report: ‘How India Perceives Mental Health,’ is the result of a five-month research project commissioned in July 2017 by TLLLF that covered 3,556 respondents across eight Indian cities. The report was released by Sanjeeva Kumar, Additional Secretary, Department of Health & Family Welfare, and Deepika Padukone, Founder - TLLLF, Anna Chandy, Chair of TLLLF’s Board of Trustees and Dr Shyam Bhat, Trustee - TLLLF. Speaking at the launch, Deepika Padukone, Founder, TLLLF said, “This research initiative is part of our ongoing efforts to build a better understanding about mental health in our country.Our research shows that only over a quarter of the respondents are willing to be supportive in many aspects, while the remaining are either judgmental or fearful of those affected with mental illness. This is an extremely unfortunate situation for us to be in. It is absolutely critical that we as a society work together towards increasing awareness, reducing stigma and normalizing the need to seek support for mental illness." Anna Chandy, Chairperson – The Board of Trustees at TLLLF, said: “Traditionally and historically, India is a collectivistic society, now slowly moving towards a more individualistic one. This transition is evident in the data presented in the report. In larger cities, we see a more dramatic shift towards individualism, possibly due to an increase in the amount of access to information and migrant need for survival. However, smaller cities like Kanpur and Patna seem to retain some of their collectivistic roots, and are moving towards an individualistic society at a slower pace." Noting that mental health had to be looked at holistically, she said, “Focussing both on decreasing stigma and increasing awareness is the key. By inculcating collectivist practices into our more individualistic lifestyles we can shape the conversation to build an inclusive society to a) provide support to people with mental illness; and b) Increase India’s awareness about mental health concerns."   ]]> <![CDATA[Dr Reddy's launches Palonosetron Hydrochloride Injection in US]]> https://biospectrumindia.com/news/95/10653/dr-reddys-launches-palonosetron-hydrochloride-injection-in-us.html https://biospectrumindia.com/news/95/10653/dr-reddys-launches-palonosetron-hydrochloride-injection-in-us.html Mon, 26 Mar 2018 13:00:00 +0530 Dr. Reddy’s Laboratories Ltd. has launched Palonosetron Hydrochloride Injection, 0.25 mg (base)/ 5 mL, a therapeutic equivalent generic version of ALOXI®(palonosetron hydrochloride) Injection approved by the U.S. Food and Drug Administration (USFDA).  The ALOXI® brand and generic had U.S. sales of approximately $446 million MAT for the most recent twelve months ending in January 2018 according to IMS Health*. Dr. Reddy’s Palonosetron Hydrochloride Injection is available in a strength of 0.25 mg/5 mL (free base) in a single-dose vial packaged in a carton containing one vial. ALOXI® is a registered trademark of Helsinn Healthcare SA. ]]> <![CDATA[Zydus Cadila receives FDA approval for Metoprolol Succinate]]> https://biospectrumindia.com/news/95/10651/zydus-cadila-receives-fda-approval-for-metoprolol-succinate.html https://biospectrumindia.com/news/95/10651/zydus-cadila-receives-fda-approval-for-metoprolol-succinate.html Mon, 26 Mar 2018 11:45:00 +0530 Zydus Cadila is an innovative, global pharmaceutical company that discovers, develops, manufactures and markets a broad range of healthcare therapies. Zydus Cadila has received the final approval from the USFDA to market Metoprolol Succinate Extended-Release Tablets USP in the strengths of 25 mg, 50 mg, 100 mg and 200 mg. The drug is used to treat chest pain (angina), heart failure and high blood pressure. Lowering high blood pressure helps prevent strokes, heart attacks and kidney problems. It will be manufactured at the group’s formulations manufacturing facility at SEZ, Ahmedabad. The group now has more than 185 approvals and has so far filed over 320 ANDAs since the commencement of the filing process in FY 2003-04. Zydus aspires to be a research-based pharmaceutical company by 2020 ]]> <![CDATA[Ping An Technology wins recognition yet again]]> https://biospectrumindia.com/news/95/10649/ping-an-technology-wins-recognition-yet-again.html https://biospectrumindia.com/news/95/10649/ping-an-technology-wins-recognition-yet-again.html Fri, 23 Mar 2018 17:55:00 +0530 The results of the Indian Diabetic Retinopathy Image Dataset (IDRiD) fundus analysis competition organized by the IEEE International Symposium on Biomedical Imaging (ISBI) were recently announced. Ping An Technology's PAMIA (Ping An Medical Imaging Assistant) performed head and shoulders above its peers, including a world first in EX (hard exudates) image segmentation, world second in HE (bleeding) segmentation and world third in MA (microaneurysm) segmentation task.  This is the second time this year that Ping An Technology has garnered awards in a world-class competition in the medical imaging research sector, heralding another milestone for the company in artificial intelligence. Earlier in the year, PAMIA had set a new record for nodule detection with an accuracy rate of 95.1 percent, and beat its own previous record for false positive reduction with an accuracy rate of 96.8 per cent in the international authoritative Lung Nodule Analysis (LUNA) rankings for medical imaging. PAMIA ranks first worldwide when it comes to EX, the most difficult yet most important lesions segmentation challenge, while ranking among the top three globally for the segmentation of other lesions. The fundus image is different from other image scenarios, as these lesions only occupy a few dozen pixels. PAMIA, in order to ensure the detection sensitivity, combined its comprehensive advantages in the field of medical diagnosis and deep learning with its experience of setting new world records in the LUNA competition at the beginning of the year to design a new segmentation network that used deep and transfer learning theories to identify suspected lesions quickly and achieve boundary segmentation. At present, the marking and segmentation of lesions can be completed in a few seconds, greatly improving the reading speed and accuracy rate. Ping An Technology has achieved several milestones in the intelligent film reading field since 2016 when it entered the medical imaging sector. These achievements reflect the company's leadership and dominant position in the technologies related to medical imaging. With this award as a new milestone, PAMIA plans to devote itself to furthering its research on medical artificial intelligence, helping to achieve a strategic development goal for China's artificial intelligence sector. ]]> <![CDATA[Suven Life Sciences secures 3 product patents]]> https://biospectrumindia.com/news/95/10642/suven-life-sciences-secures-3-product-patents.html https://biospectrumindia.com/news/95/10642/suven-life-sciences-secures-3-product-patents.html Thu, 22 Mar 2018 18:15:00 +0530 Suven Life Sciences has announced that it has been granted a patent each by Norway, South Korea and Singapore corresponding to new chemical entities (NCEs) for the treatment of disorders associated with neurodegenerative diseases. The patents are valid till 2027, 2034 and 2036, respectively, the company said in a BSE filing. "We are pleased by the grant of these patents to Suven for our pipeline of molecules in the CNS arena, which are being developed for cognitive disorders with high unmet medical need with a huge market potential globally," Suven Life CEO Venkat Jasti said. The granted claims of the patents are being developed as therapeutic agents and are useful in the treatment of cognitive impairment associated with neurodegenerative disorders like Alzheimers disease, attention deficient hyperactivity disorder (ADHD), Huntingtons disease, Parkinsons and Schizophrenia. ]]> <![CDATA[Tata Chemicals launches a pharma grade sodium bicarbonate ]]> https://biospectrumindia.com/news/95/10640/tata-chemicals-launches-a-pharma-grade-sodium-bicarbonate-.html https://biospectrumindia.com/news/95/10640/tata-chemicals-launches-a-pharma-grade-sodium-bicarbonate-.html Thu, 22 Mar 2018 15:00:00 +0530 Tata Chemicals Ltd., the country’s leading producer of Soda Ash and Sodium Bicarbonate, announced the launch of MedikarbTM – India’s first branded pharmaceutical grade sodium bicarbonate for pharma API and formulation manufacturing. MedikarbTM will be manufactured in state of the art FDA certified facilities that are compliant with GMP standards to ensure the highest quality product conforming to Indian Pharmacopoeia specifications.  Sanjiv Lal, COO, India Chemicals Operations, Tata Chemicals Ltd. said, “MedikarbTM is India’s first branded premium grade of sodium bicarbonate suitable for use as an Active Pharmaceutical Ingredient (API) and as an excipient in pharma formulations”. This will give Indian pharma manufacturers a high-quality product manufactured in a state of the art FDA certified facility from a trusted brand. MedikarbTM will be produced through a highly mechanized automated manufacturing process designed as per GMP principles. Quality of the end product is assured through an end-to-end Tata Quality Management System (QMS), with the product manufactured, processed, packed and distributed under the applicable licensing and operational guidelines. Customers will also have the backing of technical sales support through an in-house R&D and Technical Services team. Tata Chemicals' with its sodium bicarbonate business has a presence in both domestic and global market. With an annual capacity of 100,000 MT in India, the company also has two other brands SodakarbTM, customized for use as a food additive and AlkakarbTM, for use in animal feed. This introduction of MedikarbTM as a customized product will cater specifically to the pharmaceutical industry. ]]> <![CDATA[Sun Pharma gets FDA approval for Plaque Psoriasis drug]]> https://biospectrumindia.com/news/95/10636/sun-pharma-gets-fda-approval-for-plaque-psoriasis-drug.html https://biospectrumindia.com/news/95/10636/sun-pharma-gets-fda-approval-for-plaque-psoriasis-drug.html Thu, 22 Mar 2018 11:20:00 +0530 Sun Pharmaceutical Industries announced that the U.S. Food and Drug Administration (FDA) have approved ILUMYA™ (tildrakizumab-asmn) for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for systemic therapy or phototherapy. ILUMYA selectively binds to the p19 subunit of IL-23 and inhibits its interaction with the IL-23 receptor leading to inhibition of the release of pro-inflammatory cytokines and chemokines.  ILUMYA is administered at a dose of 100 mg by subcutaneous injection every 12 weeks, after the completion of initial doses at weeks 0 and 4. ILUMYA is contraindicated in patients with a previous serious hypersensitivity reaction to tildrakizumab or to any of the excipients.  The FDA approval of ILUMYA for the treatment of adults with moderate-to-severe plaque psoriasis was supported by data from the pivotal Phase-3 reSURFACE clinical development program. ]]> <![CDATA[Dr. Reddy's launches generic version of Xyzal in US]]> https://biospectrumindia.com/news/95/10617/dr-reddys-launches-generic-version-of-xyzal-in-us.html https://biospectrumindia.com/news/95/10617/dr-reddys-launches-generic-version-of-xyzal-in-us.html Mon, 19 Mar 2018 11:10:00 +0530 Dr. Reddy's Laboratories Ltd. announced that it has launched Levocetirizine Dihydrochloride Tablets USP, 5 mg, an over-the-counter therapeutic equivalent generic version of Xyzal® Allergy 24HR Tablets in the United States market as approved by the U.S. Food and Drug Administration (USFDA). Levocetirizine Dihydrochloride Tablets USP, 5 mg is an over-the-counter antihistamine used for 24-hour relief of allergy symptoms such as watery eyes, runny nose, itching eyes/nose, and sneezing. "This first-to-market launch for the store brand is the testament to the deep capabilities of our store brand OTC business,” says Milan Kalawadia, Vice President and Head, US Over-the-Counter and Speciality Rx businesses, Dr. Reddy’s Laboratories. “We look forward to collaborating with our customers to bring high-quality, affordable store brand alternatives to the market.” Dr. Reddy’s Levocetirizine Dihydrochloride Tablets USP is available in 5 mg strength and in various consumer oriented package sizes. ]]> <![CDATA[Arsanis gets Patent from USPTO for ASN100]]> https://biospectrumindia.com/news/95/10602/arsanis-gets-patent-from-uspto-for-asn100.html https://biospectrumindia.com/news/95/10602/arsanis-gets-patent-from-uspto-for-asn100.html Thu, 15 Mar 2018 17:50:00 +0530 Arsanis, Inc.,a clinical-stage biopharmaceutical company focused on applying monoclonal antibody immunotherapies to address serious infectious diseases, announced that the United States Patent and Trademark Office ("USPTO") issued U.S. Patent No. 9914767 to the company. This patent broadly claims composition of matter for antibodies that cross-neutralize Staphylococcus aureus alpha hemolysin (Hla) and up to four additional S. aureus leukocidins targeted by ASN-1, one of the two antibodies in the company’s lead product candidate, ASN100. ASN100 is a combination of two fully human monoclonal antibodies (mAbs) that together neutralize the six cytotoxins critical to S. aureus pneumonia pathogenesis, including toxins that damage lung tissue and destroy human immune cells. This patent grants intellectual property protection in the United States through 2033. “The USPTO granting of this important patent follows similar patents for the composition-of-matter for these cross-reactive antibodies, including patent grants issued by the European Patent Office in 2015, and by the Japan Patent Office and IP Australia in 2017,” said Michael Gray, chief operating officer and chief financial officer of Arsanis. “We plan to continue our efforts to strengthen our intellectual property portfolio for ASN100 and our other pipeline programs.” ]]> <![CDATA[OptraSCAN introduces Third Generation On-Demand Digital Pathology® System ]]> https://biospectrumindia.com/news/95/10598/optrascan-introduces-third-generation-on-demand-digital-pathology-system-.html https://biospectrumindia.com/news/95/10598/optrascan-introduces-third-generation-on-demand-digital-pathology-system-.html Thu, 15 Mar 2018 11:35:00 +0530 OptraSCAN announced its third generation On-Demand Digital Pathology® system for researchers and clinicians. The third generation OptraSCAN® brightfield scanner is now able to acquire a whole slide image from a FFPE glass slide in under 60 seconds timeframe at the cost of a traditional digital microscope.  Dr. Clive Taylor, CMO, OptraSCAN, unveiling 3rd Gen High-Speed & Affordable Scanner in presence of founders Dr. Gauri Naik and Abhi Gholap CEO Abhi Gholap will be present at USCAP for meetings and personal demonstrations of the On-Demand Digital Pathology suite of solutions.  Keeping true to its mission statement, OptraSCAN has been working to make digital pathology affordable and accessible to all pathologists worldwide. The third generation system, with faster scan times, will provide technicians and physicians access to images quickly and help keep their workflow moving at a steady pace. This next generation system is being unveiled at $20,000 USD price and includes On-Demand Digital Pathology solutions IMAGEPath® image management and TELEPath™ telepathology (amongst others).  “Our goal at OptraSCAN has always been to build a solution for the global pathology community that removes the bottleneck of price,” said Founder and CEO Abhi Gholap.  Early this year Optra SCAN announced its mass validation and approval from the Government of India for use of its digital pathology system in research and medical settings. Going forward, OptraSCAN is in the process of applying for a CE Mark for medical device clearance in the EU. ]]> <![CDATA[USFDA approves Strides Shasun's HIV drug]]> https://biospectrumindia.com/news/95/10596/usfda-approves-strides-shasuns-hiv-drug.html https://biospectrumindia.com/news/95/10596/usfda-approves-strides-shasuns-hiv-drug.html Thu, 15 Mar 2018 10:30:00 +0530 Bengaluru based pharmaceutical company Strides Shasun has received approval from the US health regulator for its generic Efavirenz tablet USP, 600mg  used for treatment of HIV Type-1 infected adults and adolescents. The product will be manufactured at the company's oral dosage facility at Bengaluru and will be marketed by Strides Pharma Inc in the US market. Efavirenz Tablet is a generic version of Sustiva Tablets of Bristol-Myers Squibb Company. According to IQVIA data, the US market for Efavirenz Tablets USP, 600 mg is approximately $115 million and Strides is only the second generic company to get the approval for the product under the para IV route.   ]]> <![CDATA[Guided Therapeutics ready to sale LuViva in India]]> https://biospectrumindia.com/news/95/10590/guided-therapeutics-ready-to-sale-luviva-in-india.html https://biospectrumindia.com/news/95/10590/guided-therapeutics-ready-to-sale-luviva-in-india.html Wed, 14 Mar 2018 11:45:00 +0530 Guided Therapeutics, Inc. is the maker of a rapid and painless testing platform based on its patented biophotonic technology that utilizes light for the early detection of disease at the cellular level. The company received Regulatory Approval from the Indian Ministry of Health & Family Welfare to allow commercialization of the LuViva device and disposables. The Ministry concluded that the LuViva device is “Non Invasive” and as such is “not regulated under the Drugs and Cosmetics Act 1940 and Medical Device Rules 2017 thereunder.” As a result, LuViva can now be commercialized in India.  LuViva doesn’t require a patient sample or a laboratory, and a result is given in approximately 1 minute at the point of care. There are about 2.6 billion women aged 15 years and older who are at risk of developing cervical cancer worldwide. The world market for cervical cancer screening and diagnostics, as currently practiced using cytology (Pap test) for primary screening, is estimated at $6 billion and is projected to grow to almost $9 billion by 2020. ]]> <![CDATA[Sciex introduces OptiFlow Quant Solution for BioPharma Peptide Quantitation]]> https://biospectrumindia.com/news/95/10585/sciex-introduces-optiflow-quant-solution-for-biopharma-peptide-quantitation.html https://biospectrumindia.com/news/95/10585/sciex-introduces-optiflow-quant-solution-for-biopharma-peptide-quantitation.html Tue, 13 Mar 2018 16:30:00 +0530 SCIEX, a global leader in life science analytical technologies, introduced the OptiFlow Quant Solution for easy yet highly sensitive biomolecule quantitation. This latest addition to the growing line of SCIEX solutions for biopharmaceutical laboratories comprises the new M5 Microflow LC with Phenomenex microflow columns and new OptiFlow™ Turbo V™ Source. It offers scientists the most flexible microflow quantitation solution with better sensitivity than analytical flow systems, but without sacrificing robustness or usability. Pharmaceutical, biopharmaceutical and contract research organizations (CRO) currently struggling with bioanalysis projects on challenging analytes, such as peptides, mAbs, and ADCs, will now be able to obtain better data while achieving maximal throughput by utilizing microflow separations, without the traditional complex setup and impact of low flow workflows. SCIEX users now have a simple and easy path to boost sensitivity, allowing the laboratory to reach the ultimate limits of quantitation. Dominic Gostick, Vice President and General Manager, SCIEX stated that “The OptiFlow Quant Solution enables researchers to easily adopt microflow workflows that save time and cost, and improve throughput for development of quantitation methods for challenging analytes." ]]> <![CDATA[Agilent won two 2018 Scientists’ Choice Awards]]> https://biospectrumindia.com/news/95/10584/agilent-won-two-2018-scientists-choice-awards.html https://biospectrumindia.com/news/95/10584/agilent-won-two-2018-scientists-choice-awards.html Tue, 13 Mar 2018 12:55:00 +0530 Agilent Technologies Inc. is a global leader in life sciences, diagnostics, and applied chemical markets. The company has received two 2018 Scientists' Choice Awards; Best New Separation Product for the Agilent 1260 Infinity II Prime LC system and Best New Spectroscopy Product for the Agilent Ultivo Triple Quadrupole LC/MS system. SelectScience announced the winners of the 2018 Scientists’ Choice Awards during a special ceremony held on February 28 at the international conference Pittcon 2018 in Orlando FL. This year marks the third time Agilent products have won Scientists’ Choice Awards in both best new separation and best new spectroscopy categories. The Agilent 1260 Infinity II Prime LC system offers outstanding functionality and operational convenience for HPLC and UHPLC analysis. Excellent results are achieved with the system’s pressure range (up to 800 bar) together with the automation capabilities which reduces error-prone manual interaction. Agilent’s Intelligent System Emulation Technology (ISET) facilitates seamless transfer of methods between LCs, regardless of the brand.  The Agilent Ultivo Triple Quadrupole LC/MS system was designed around customer workflows that require robust performance, superior uptime, and easy serviceability, all in a footprint that is 70% smaller than previous instruments. Agilent’s user configurable Quant-My-Way MassHunter software interface makes the Ultivo one of the most user-friendly triple quadrupole LC/MS systems, allowing scientists to significantly increase their analytical throughput without having to increase the size of their existing laboratories or incur costly software training. When combined with the 1260 Infinity II Prime LC system, these two instruments make a powerful LC/MS triple quadrupole system. ]]> <![CDATA[CDSCO to set up support system for pharma sector]]> https://biospectrumindia.com/news/95/10576/cdsco-to-set-up-support-system-for-pharma-sector.html https://biospectrumindia.com/news/95/10576/cdsco-to-set-up-support-system-for-pharma-sector.html Fri, 09 Mar 2018 12:55:00 +0530 At the Central Drugs Standard Control Organisation in New Delhi, a new public relation office will be operative soon. It would serve as a ‘single window’ for disposal of grievances of stakeholders as well as provide information to innovators regarding regulatory requirements for commercialisation of their products. The new facility would be headed by Assistant Drugs Controller (India) Sunil Kulshreshtra, Drug Inspector Sanjay Aggarwal and Assistant Drug Inspector Vibha Sharma. They would be reporting to the Drugs Controller General of India (DCGI) S. Eswara Reddy. Mr. Reddy had spoken on the plan to set up a dedicated cell for supporting and providing information pertaining to the regulations to start-ups in the pharma sector, at the BioAsia 2018 held in Hyderabad recently.  The public relation office would provide clarifications pertaining to Drugs & Cosmetics Act-1940 and other rules. It would guide and assist the investors in various phases of the business lifecycle.  Big firms or start-ups working on innovative products or solutions can approach the office at any stage for any purpose. It would give information on the regulatory framework that they need to comply with for market authorisation or commercialisation of their products. ]]> <![CDATA[Lupin inks research pact with CSIR-NCL, DST]]> https://biospectrumindia.com/news/95/10573/lupin-inks-research-pact-with-csir-ncl-dst.html https://biospectrumindia.com/news/95/10573/lupin-inks-research-pact-with-csir-ncl-dst.html Fri, 09 Mar 2018 10:45:00 +0530 Lupin has entered into an agreement with CSIR-National Chemical Laboratory (CSIR-NCL, Pune) and Department of Science and Technology, (DST, Delhi) for conducting research on a continuous purification process development of a biosimilar monoclonal antibody therapeutic (mAb). With an increasing demand for biosimilar therapeutics and an ever-increasing pressure for manufacturing cost reduction with quality maintenance, the biopharmaceutical industry is showing keen interest in the development of continuous manufacturing processes. Through this research collaboration, CSIR-NCL and Lupin would together work towards the development of a novel continuous purification process for manufacturing mAb therapeutics. Biopharmaceuticals, biologics and monoclonal antibodies are the next wave of discovery and innovation in new pharmaceuticals. ]]> <![CDATA[Microsoft & Apollo Hospitals builds an AI system to detect cardiac diseases promptly]]> https://biospectrumindia.com/news/95/10572/microsoft-apollo-hospitals-builds-an-ai-system-to-detect-cardiac-diseases-promptly.html https://biospectrumindia.com/news/95/10572/microsoft-apollo-hospitals-builds-an-ai-system-to-detect-cardiac-diseases-promptly.html Thu, 08 Mar 2018 16:45:00 +0530 At the Healthcare Information and Management Systems Society (HIMSS) annual conference and exhibition in Las Vegas, Microsoft announced the expansion of the Microsoft Intelligent Network for eye care (MINE). Microsoft has now partnered with Apollo Hospitals to create an AI-focused network in cardiology.  This is part of Microsoft Healthcare NExT to accelerate innovation through artificial intelligence and cloud computing. The partnership between Microsoft and Apollo will work to develop and deploy new machine learning models to predict patient risk for heart disease and assists doctors on treatment plans.  The team is already working on an AI-powered Cardio API (application program interface) platform. This union will be a major step in the journey towards providing accessible healthcare to everyone. Microsoft Intelligent Network for Eyecare is an association of eye care providers, led by L V Prasad Eye Institute and include Bascom Palmer - University of Miami, Flaum Eye Institute - University of Rochester (USA), Federal University of Sao Paulo (Brazil) and Brien Holden Vision Institute (Australia). ]]> <![CDATA[Zydus teams up with Medicure to introduce cholestrol drug in US]]> https://biospectrumindia.com/news/95/10570/zydus-teams-up-with-medicure-to-introduce-cholestrol-drug-in-us.html https://biospectrumindia.com/news/95/10570/zydus-teams-up-with-medicure-to-introduce-cholestrol-drug-in-us.html Thu, 08 Mar 2018 13:35:00 +0530 Zydus Cadila has entered into a definitive agreement with US-based Medicure International Inc. to commercialise its new drug application (NDA) product pitavastatin magnesium in the US. The launch of ZYPITAMAG, which is used to manage cholesterol levels, marks the first branded product launch for Zydus in the US As part of this agreement, Zydus will hold the NDA and Medicure will be responsible for the sales and marketing of ZYPITAMAG. ZYPITAMAG has been approved in strengths of 1 mg, 2 mg and 4 mg. ]]> <![CDATA[Abbott develops world’s first tiny Mechanical Heart Valve ]]> https://biospectrumindia.com/news/95/10561/abbott-develops-worlds-first-tiny-mechanical-heart-valve-.html https://biospectrumindia.com/news/95/10561/abbott-develops-worlds-first-tiny-mechanical-heart-valve-.html Wed, 07 Mar 2018 12:25:00 +0530 Abbott  announced that U.S. Food and Drug Administration (FDA) approved the Masters HP™ 15mm rotatable mechanical heart valve, the world's smallest mechanical heart valve, that will allow doctors to treat babies and toddlers in need of a mitral or aortic valve replacement. Until today, surgeons could only use a range of larger-sized valves to replace a pediatric heart valve that could not be repaired, and larger valves are often not suitable given the smaller size of children's hearts. This dime-sized new valve is the first and only pediatric mechanical heart valve developed for newborns and infants, and offers hope for pediatric patients in urgent need of treatment who have no other approved options. ]]> <![CDATA[Centaur, Kibow Biotech team up to market Renadyl in India for CKD]]> https://biospectrumindia.com/news/95/10559/centaur-kibow-biotech-team-up-to-market-renadyl-in-india-for-ckd.html https://biospectrumindia.com/news/95/10559/centaur-kibow-biotech-team-up-to-market-renadyl-in-india-for-ckd.html Wed, 07 Mar 2018 11:40:00 +0530 Centaur Pharmaceuticals and Kibow Biotech USA has announced a strategic long-term alliance to market Renadyl in India. Centaur will initially import and market the product in India, and will eventually manufacture and market with technical inputs from Kibow Biotech. In an opening address, Mr. Gregory Taevs thanked Centaur and Kibow for inviting him to the occasion & wished the strategic alliance a grand success. Commenting on this strategic alliance, Dr. Natrajan Ranganathan, Ph.D. (Bio-organic Chemistry), inventor of the globally patented product, and the Founder and Managing Director of Kibow Biotech, said, “As my roots are from India, I am extremely happy that my company Kibow Biotech has collaborated with Centaur Pharmaceuticals. Now we can together offer the benefits of my 20 years of research to millions of Indian patients suffering from Chronic Kidney Disease (CKD) and make their lives better. Kibow also has an interesting research pipeline which we hope to bring to India for the benefit of Indian patients.” Speaking on this occasion, Mr. S. D. Sawant, Chairman and MD of Centaur Pharmaceuticals, said, “Kibow has a strong research infrastructure and expertise in modulating gut microbiome. Through this alliance, Centaur will leverage Kibow’s research expertise and its own strong manufacturing and marketing skills to offer hope in the form of Renadyl to patients in India suffering from CKD. We are happy to announce this alliance in the backdrop of World Kidney Day and World Women’s Day coming up on 8th March, A globally patented product, Renadyl, is an effective kidney health therapy, targeted towards CKD patients, particularly those in Stage III/ IV (pre-dialysis). Renadyl is clinically proven to reduce nitrogenous waste and delay the need for dialysis. Renadyl also provides improved quality of life for Stage V patients on dialysis. ]]> <![CDATA[Mitra Biotech announces CAP accreditation]]> https://biospectrumindia.com/news/95/10538/mitra-biotech-announces-cap-accreditation.html https://biospectrumindia.com/news/95/10538/mitra-biotech-announces-cap-accreditation.html Mon, 05 Mar 2018 17:15:00 +0530 Mitra Biotech, a global leader in advancing the personalization of cancer treatment, has announced that its Woburn, MA laboratory facility is now accredited by the College of American Pathologists (CAP) Laboratory Accreditation Program. Mitra's CANscript platform recreates a patient's own tumor microenvironment in vitro, measures multiple parameters to determine whether a tumor is responding to physician-selected treatments, and then converts these parameters into a single score that predicts clinical response to each of the physician-selected therapies. According to CAP's website, the Laboratory Accreditation Program inspects a variety of laboratory settings from complex university medical centers to physician office laboratories, and covers a complete array of disciplines and testing procedures. This peer-based inspection model helps laboratories: Meet Clinical Laboratory Improvement Amendments (CLIA) Regulatory Requirements, Ensure compliance through the guidance of the most comprehensive scientifically endorsed laboratory standards, Maintain accuracy of test results and ensure accurate patient diagnosis, and Increase the value they bring to organizations, customers, and patients. "We're dedicated to being a leader in advancing patient care," said Mallik Sundaram, Mitra CEO and Co-Founder. "The CAP accreditation reflects the high standards to which we hold ourselves accountable, and we are honored to receive this prestigious recognition." CANscript delivers powerful, individualized treatment response predictions — with exceptionally high correlation to clinical outcomes — to inform patient-specific cancer treatment selection and support more effective and efficient cancer drug development. CANscript has been validated using thousands of cancer cases, with a published 90% overall correlation between the platform's treatment predictions and actual clinical outcomes. Founded in 2010, Mitra is headquartered in Greater Boston and maintains a significant research and laboratory presence in Bengaluru, India. An accomplished leadership team of industry professionals heads the company, with a dedicated focus on enhancing the personalization of cancer treatment and care worldwide. ]]> <![CDATA[USFDA approves Zydus Cadila’s sedative injection]]> https://biospectrumindia.com/news/95/10510/usfda-approves-zydus-cadilas-sedative-injection.html https://biospectrumindia.com/news/95/10510/usfda-approves-zydus-cadilas-sedative-injection.html Thu, 01 Mar 2018 11:55:00 +0530 Zydus Cadila provides total healthcare solutions ranging from formulations, active pharmaceutical ingredients and animal healthcare products to wellness products. The company has received final approval from US health regulator to market Dexmedetomidine Hydrochloride injection used for sedation of intubated and mechanically ventilated patients. The approval from USFDA is to market Dexmedetomidine Hydrochloride injection 200 mcg (base)/ 2 ML and 100 mcg (base)/ ML single dose virals. The injection will be manufactured at the group's formulations manufacturing facility at Moraiya, Ahmedabad. The drug is indicated for sedation of intubated and mechanically ventilated patients during treatment in an intensive care setting and for sedation of non-intubated patients prior to and/or during surgical and other procedures. ]]> <![CDATA[ABL Europe unites with Hookipa Biotech]]> https://biospectrumindia.com/news/95/10509/abl-europe-unites-with-hookipa-biotech.html https://biospectrumindia.com/news/95/10509/abl-europe-unites-with-hookipa-biotech.html Thu, 01 Mar 2018 11:20:00 +0530 Hookipa Biotech AG, a clinical stage biotech company aiming to develop best-in-class active immunization therapies for infectious diseases and oncology. ABL Europe SAS, an ABL Inc. company providing dedicated viral vector GMP contract manufacturing (CMO) services for oncolytic, vaccine and gene therapy projects in all stages of clinical development through to commercial launch, have entered in a manufacturing collaboration. Under the agreement, ABL will perform process transfer, scale-up and GMP manufacturing of attenuated replicating viral vectors based on Hookipa's proprietary arenavirus heterologous TheraT® platform. Under the manufacturing collaboration, Hookipa will utilize the recently expanded GMP viral vector facilities and capacities of ABL Europe's new state-of-the-art single use suite able to support both adherent and suspension cell culture capabilities at a 200 L and 500 L SUB scale. In addition to the supply of drug substance, ABL will manufacture aseptic drug product for Hookipa in-house at the Strasbourg facility, able to accommodate batch sizes in the region of 10,000 vials. ]]> <![CDATA[Hetero launches anti-retroviral drug in India]]> https://biospectrumindia.com/news/95/10508/hetero-launches-anti-retroviral-drug-in-india.html https://biospectrumindia.com/news/95/10508/hetero-launches-anti-retroviral-drug-in-india.html Thu, 01 Mar 2018 10:55:00 +0530 Hyderabad based Hetero Healthcare has recently launched generic anti-retroviral fixed-dose combination (FDC) of ‘Emtricitabine (200mg) and Tenofovir Alafenamide (25mg) in India. The product is the first generic version of Gilead’s Descovy. The product has been approved by the Drug Controller General of India (DCGI) and will be marketed and distributed under the brand name ‘TAFERO-EM’. The medication is indicated in combination with other anti-retroviral agents for the treatment of human immunodeficiency virus (HIV-1) infection in adults and pediatric patients 12 years of age and older. ]]> <![CDATA[Cipla teams up with Roche to sell 2 cancer drugs in India]]> https://biospectrumindia.com/news/95/10499/cipla-teams-up-with-roche-to-sell-2-cancer-drugs-in-india.html https://biospectrumindia.com/news/95/10499/cipla-teams-up-with-roche-to-sell-2-cancer-drugs-in-india.html Wed, 28 Feb 2018 11:00:00 +0530 Mumbai based drug firm Cipla has entered into an agreement with Roche Pharma to promote and distribute the latter's cancer drugs in India. The pharma major will distribute Tocilizumab and Syndyma, the second brand of Roche's cancer therapy bevacizumab in India. This partnership is in line with Cipla and Roche's efforts to improve healthcare and increase access to innovative, life-changing medicines in India, particularly to patients who currently do not have access to them. Accroding to cipla, the prevalence of cancer and rheumatoid arthritis is widely spread across India, and the company intends to contribute to provide broader access to innovative medicines like tocilizumab and bevacizumab. ]]> <![CDATA[OPTIMA pharma offers a glimpse into the future ]]> https://biospectrumindia.com/news/95/10496/optima-pharma-offers-a-glimpse-into-the-future-.html https://biospectrumindia.com/news/95/10496/optima-pharma-offers-a-glimpse-into-the-future-.html Tue, 27 Feb 2018 15:20:00 +0530 Smart Solutions for Pharma experts is the Optima Pharma theme at Achema 2018. Small batch sizes and flexible filling equipment and processes are trending requirements for the pharmaceutical industry. With the MultiUse platform, Optima Pharma offers a concept for pharmaceutical companies to handle small batch sizes and diverse container types. Optima Pharma also introduces Comprehensive Scientific Process Engineering (CSPE), a process that generates a timeline from the order to start of production that is safe and efficient. The freeze dryer CS and the sterility test isolator STISO are two new developments by Optima Pharma and will be displayed at Achema. ]]> <![CDATA[Eli Lilly announces additional FDA approval for Verzenio]]> https://biospectrumindia.com/news/95/10488/eli-lilly-announces-additional-fda-approval-for-verzenio.html https://biospectrumindia.com/news/95/10488/eli-lilly-announces-additional-fda-approval-for-verzenio.html Tue, 27 Feb 2018 10:55:00 +0530 Eli Lilly and Company (LLY) announced the U.S. FDA has approved Verzenio (abemaciclib) in combination with an aromatase inhibitor as initial endocrine-based therapy for the treatment of postmenopausal women with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced or metastatic breast cancer.  The company noted that the additional FDA approval marks the third indication for Verzenio within five months. The recommended dose of Verzenio in combination with an aromatase inhibitor is 150 mg orally twice daily, continued until disease progression or unacceptable toxicity. Verzenio is available in four tablet strengths. ]]> <![CDATA[Novo Nordisk presents the first successful data for diabetes pill]]> https://biospectrumindia.com/news/95/10485/novo-nordisk-presents-the-first-successful-data-for-diabetes-pill.html https://biospectrumindia.com/news/95/10485/novo-nordisk-presents-the-first-successful-data-for-diabetes-pill.html Mon, 26 Feb 2018 17:35:00 +0530 Novo Nordisk, the world’s largest diabetes drugmaker has presented the first successful data from a large final-stage study of a pill it hopes will transform the diabetes market. The oral form of the drug, known generically as semaglutide, is crucial for ensuring the group's long-term growth, as price pressure mounts in a crowded market targeting the world's 450 million diabetics. The new medicine is a threat to Eli Lilly, a key rival in the multibillion-dollar diabetes market. Novo said the first of 10 Phase III trials that are due this year had met its primary goal by demonstrating "significant and superior" improvements in long-term blood sugar levels compared to a placebo. The trial also showed that the highest of the three tested doses - 3, 7 and 14 mg demonstrated "significant and superior" weight loss. While weight loss was also observed for two lower doses, they did not reach statistical significance. Importantly, nausea was not a major problem with the new pill, as some experts had feared. The once-daily pill belongs to a blockbuster class of treatments known as GLP-1s that stimulate insulin production, the first of which were derived from the venomous bite of North America's Gila monster lizard. So far, all have been injections. UBS analyst Michael Leuchten said the blood sugar reductions were as good if not better than those achieved with two successful injectable GLP-1 medicines - Lilly's Trulicity and Novo's own Victoza. The fact that mild-to-moderate nausea was reported in just 5 to 16 percent of patients - less than nausea levels observed with injections - was also a positive surprise. Novo Nordisk said it aims to provide data from the remaining nine trials this year and expects to submit the drug for regulatory approval in 2019, ahead of the drug's potential 2020 launch. Doctors believe oral semaglutide will provide a new weapon to tackle diabetes earlier with a highly effective therapy, especially in patients who are reluctant to start on injections. But price will be critical in determining its uptake both among U.S. insurers and cost-conscious European healthcare systems.   ]]> <![CDATA[Mylan launches natural female hygiene product Saugella in India]]> https://biospectrumindia.com/news/95/10480/mylan-launches-natural-female-hygiene-product-saugella-in-india.html https://biospectrumindia.com/news/95/10480/mylan-launches-natural-female-hygiene-product-saugella-in-india.html Mon, 26 Feb 2018 15:55:00 +0530 Mylan Pharmaceuticals Private Limited recently announced the launch of SAUGELLA Dermoliquido, suitable for use for daily intimate hygiene use, and SAUGELLA Attiva, designed for expecting mothers, new mothers, women athletes, and for protection from infection during menstruation. Rakesh Bamzai, President, India and Emerging Markets said, “While the awareness of intimate hygiene products in India is growing, women are wary about using them for fear of chemicals used in these products being harmful for the skin. SAUGELLA is backed by 40 years of intense research with its efficacy, safety and tolerability well tested in studies covering more than 2,000 research volunteers, including young and middle-aged women, and expectant and new mothers. With SAUGELLA, women across the country can now take care of intimate hygiene with surety and confidence.” India's first ‘natural’ feminine intimate hygiene product, SAUGELLA intimate hygiene wash is pH-balanced, 100% free of preservatives used in cosmetic/pharmaceutical products, and is tested by gynecologists. SAUGELLA is based on natural plants extracts with pharmacological properties. It is a mild, water-based solution that addresses the intimate personal care needs of women while ensuring safety and respecting the physiological vaginal environment for all ages. SAUGELLA contains natural plant extracts, which have proven antifungal and antibacterial action that allow it to gently deodorize the area of application and provide a balanced solution that caters to every skin type. This gentle formula is designed to maintain hygiene, comfort and intimate balance, while preventing skin irritation and making women less susceptible to infections caused by natural changes in vaginal pH. With today’s fast paced and dynamic lifestyles, women have become more prone to infections and need to pay special attention to personal hygiene. Research indicates that more than 90% of Indian women suffer from a vaginal infection at least once during their life time. In healthy women, the normal vaginal environment has certain ‘good bacteria’ that protect the vagina and prevent infection by harmful bacteria. Using SAUGELLA regularly can help maintain this healthy environment in a safe and effective manner that in turn improves the overall vaginal health and wellness. The two variants of SAUGELLA, SAUGELLA Dermoliquido and SAUGELLA Attiva are available in a 100ml bottle and a 250ml value pack. ]]> <![CDATA[Strides Shasun, Vivimed Labs to launch ranitidine OTC tablets in US]]> https://biospectrumindia.com/news/95/10477/strides-shasun-vivimed-labs-to-launch-ranitidine-otc-tablets-in-us.html https://biospectrumindia.com/news/95/10477/strides-shasun-vivimed-labs-to-launch-ranitidine-otc-tablets-in-us.html Mon, 26 Feb 2018 13:15:00 +0530 Bengaluru based Strides Shasun has entered into a 50:50 joint venture (JV) with Vivimed Labs to launch ranitidine tablets USP, 150 mg (OTC) in the US markets. The company is already a key player in the US ranitidine Rx market with 32 per cent market share through its approval for ranitidine tablets USP, 150 mg and 300 mg. The new launch will further strengthen company’s ranitidine franchise. According to IRI data, the US OTC market for ranitidine tablets, which is the generic form of the popular brand Zantac, is approximately $ 200 million. This is the first product approval from company’s 50:50 JV with Vivimed Labs. The product will be backward integrated and will be manufactured at the JV’s Oral dosage facility in Chennai. Strides will have exclusive marketing rights for the product in the US. Ranitidine belongs to a class of drugs known as H2 histamine blockers. It is used to treat peptic ulcers of the stomach and intestines and gastroesophageal reflux and heartburn related to indigestion. ]]> <![CDATA[GSK confers new efficacy data for Influenza Vaccine]]> https://biospectrumindia.com/news/95/10466/gsk-confers-new-efficacy-data-for-influenza-vaccine.html https://biospectrumindia.com/news/95/10466/gsk-confers-new-efficacy-data-for-influenza-vaccine.html Fri, 23 Feb 2018 16:45:00 +0530 GSK presented at the Centers for Disease Control and Prevention (CDC) Advisory Committee on Immunization Practices meeting that FLUARIX® QUADRIVALENT demonstrated 63.2% efficacy against moderate to severe influenza and 49.8% efficacy against influenza of any severity in children 6 months through 35 months of age. These results are based on a randomized, observer-blind, non-influenza vaccine-controlled trial that enrolled 12,018 children in five independent cohorts in 13 countries in Asia, Europe, and Central America from 2011 through the end of 2014. FLUARIX® QUADRIVALENT was immunogenic against all four vaccine strains (i.e., A/H1N1, A/H3N2, B/Victoria and B/Yamagata). The safety and reactogenicity profile was similar to vaccines used in the same age group. No safety signal was observed. Additionally, the study found that FLUARIX® QUADRIVALENT reduced healthcare utilization (i.e., antibiotic use, general practitioner visits and emergency department visits) related to confirmed influenza illness. ]]> <![CDATA[India signs pharma pact with Uzbekistan]]> https://biospectrumindia.com/news/95/10465/india-signs-pharma-pact-with-uzbekistan.html https://biospectrumindia.com/news/95/10465/india-signs-pharma-pact-with-uzbekistan.html Fri, 23 Feb 2018 15:20:00 +0530 India and the Andijan Region of Uzbekistan have inked an agreement for cooperation in the pharmaceutical industry. Both sides will develop cooperation in the implementation of a program for the production of pharmaceutical, bio-pharmaceutical products and medical equipment in the Andijan region of Uzbekistan. Both the countries have agreed to work together in principle on the issue of creating an Uzbek-Indian free pharmaceutical zone in the Andijan region and start joint development of a business plan for this project. Both sides will be working on the issue of attracting direct investments of Indian companies and Uzbek investors to create modern production facilities for the production of pharmaceutical products and medicines with high value. ]]> <![CDATA[Novartis announces CLAIM study for COPD]]> https://biospectrumindia.com/news/95/10459/novartis-announces-claim-study-for-copd.html https://biospectrumindia.com/news/95/10459/novartis-announces-claim-study-for-copd.html Fri, 23 Feb 2018 11:35:00 +0530 Novartis has announced the publication of the CLAIM* study in the Lancet Respiratory Medicine, which demonstrated that treatment once-daily Ultibro® Breezhaler® (indacaterol/glycopyrronium 110/50 mcg) significantly improved lung and cardiac function, when compared to placebo, in chronic obstructive pulmonary disease (COPD) patients with lung hyperinflation. Many people living with COPD are at increased risk of death and disability due to comorbid cardiovascular disease. Lung hyperinflation is common in people with COPD3, and has been linked to impaired cardiac function and a worsening of COPD symptoms, especially breathlessness4-6. CLAIM is the first study to investigate the effects of dual bronchodilation on cardiac function and lung hyperinflation. The CLAIM study met its primary endpoint demonstrating that treatment with Ultibro Breezhaler led to decreased lung hyperinflation and improvements in cardiac function after 14 days of treatment1. This translated into clinically relevant patient benefits of improved health status and breathlessness (dyspnea), studied as exploratory endpoints. The CLAIM study was a randomized, double-blinded, placebo-controlled, single-center, two period cross-over study comparing the effects of 14-day Ultibro® Breezhaler® therapy with placebo on cardiac and lung function in hyperinflated COPD patients1. It involved a total of 62 patients, of whom 57 completed both treatment periods1. All patients had moderate-to-very severe COPD and confirmed lung hyperinflation (residual volume >135% predicted). The primary endpoint of the study was to demonstrate the effect of 14-day once-daily Ultibro Breezhaler treatment on left ventricular end-diastolic volume (LV-EDV) as measured by MRI1. Secondary endpoints included effects on lung function parameters as measured by residual volume (RVol), forced expiratory volume in one second (FEV1) and forced vital capacity (FVC). Cardiac assessments included right ventricular end-diastolic volume (RV-EDV), left and right ventricular stroke volume (LV-SV and RV-SV), left and right ventricular end-systolic volumes (LV-ESV and RV-ESV) and cardiac index (CI). Shreeram Aradhye, Chief Medical Officer and Global Head of Medical Affairs for Novartis Pharmaceuticals said, “Lung hyperinflation is often associated with impaired cardiac function in patients with COPD. The publication of the CLAIM study is important for any COPD patient with signs of lung hyperinflation. For the first time, we demonstrated that treatment with Ultibro Breezhaler can reduce lung hyperinflation and improve cardiac function, breathlessness and health status.” In the CLAIM study Ultibro Breezhaler was well tolerated and its safety profile was comparable with placebo.   ]]> <![CDATA[Glenmark, SCD Pharma sign pact for marketing ophthalmic products]]> https://biospectrumindia.com/news/95/10458/glenmark-scd-pharma-sign-pact-for-marketing-ophthalmic-products.html https://biospectrumindia.com/news/95/10458/glenmark-scd-pharma-sign-pact-for-marketing-ophthalmic-products.html Thu, 22 Feb 2018 15:30:00 +0530 Global pharmaceutical company, Glenmark Pharmaceuticals has entered into an exclusive agreement with Sam Chun Dang Pharm. Co. Ltd. (SCD), to develop, manufacture and market a portfolio of ophthalmic products in the US and Canada. As per the agreement, these products will be developed and manufactured by SCD in South Korea. Glenmark will seek all market authorizations and commercialize the products in North America. It is expected that Glenmark will file six Abbreviated New Drug Applications (ANDAs) in the first half of 2019 for the licensed SCD ophthalmic products. According to IMS sales figures, the US brand sales for the six products was approximately $1.7 billion for calendar year 2017. ]]> <![CDATA[Lupin receives FDA approval for generic Tamiflu for Oral Suspension]]> https://biospectrumindia.com/news/95/10453/lupin-receives-fda-approval-for-generic-tamiflu-for-oral-suspension.html https://biospectrumindia.com/news/95/10453/lupin-receives-fda-approval-for-generic-tamiflu-for-oral-suspension.html Wed, 21 Feb 2018 15:35:00 +0530 Pharma major Lupin announced that it has received final approval for its Oseltamivir Phosphate for Oral Suspension from the United States Food and Drug Administration (FDA) to market the generic version of Hoffman-La Roche, Inc.’s Tamiflu for Oral Suspension, 6 mg/mL. Lupin shall commence promoting the product shortly. Lupin’s Oseltamivir Phosphate for Oral Suspension, 6 mg (base)/mL is AB rated generic equivalent of Hoffman-La Roche, Inc’s Tamiflu® for Oral Suspension, 6 mg (base)/mL. Oseltamivir Phosphate for Oral Suspension, 6 mg (base)/mL is indicated for i) treatment of acute, uncomplicated influenza A and B in patients 2 weeks of age and older who have been symptomatic for no more than 48 hours and ii) prophylaxis of influenza A and B in patients 1 year and older. Oseltamivir Phosphate for Oral Suspension, 6 mg (base)/mL had annual sales of approximately USD 358 million in the US (IQVIA MAT October 2017).     ]]> <![CDATA[Lupin launches generic Namenda XR capsules in the US]]> https://biospectrumindia.com/news/95/10452/lupin-launches-generic-namenda-xr-capsules-in-the-us.html https://biospectrumindia.com/news/95/10452/lupin-launches-generic-namenda-xr-capsules-in-the-us.html Wed, 21 Feb 2018 15:30:00 +0530 Pharma major Lupin announced the launch of its Memantine Hydrochloride Extended-Release Capsules, 7mg, 14mg, 21mg, 28mg having received an approval from the United States Food and Drug Administration (FDA) earlier. Lupin’s Memantine Hydrochloride ER capsules 7mg, 14mg, 21mg, 28mg are the generic equivalents of Allergan’s Namenda XR® capsules. It is indicated for the treatment of moderate to severe dementia of the Alzheimer’s type. Memantine Hydrochloride ER capsules 7mg, 14mg, 21mg, 28mg had annual sales of approximately USD 936 million in the US (IQVIA MAT December 2017). ]]> <![CDATA[GNH India clears Oman Pharmacy and Poison board audit]]> https://biospectrumindia.com/news/95/10449/gnh-india-clears-oman-pharmacy-and-poison-board-audit.html https://biospectrumindia.com/news/95/10449/gnh-india-clears-oman-pharmacy-and-poison-board-audit.html Wed, 21 Feb 2018 14:50:00 +0530 GNH India which is a global source for priority pharmaceuticals has cleared an audit conducted by the Muscat Pharmacy and Poisons board to export pharmaceuticals and priority medications into the Gulf state of Oman. Earlier GNH India had cleared audits to trade orphan drugs with the UK. In 2010, India ranked fifth largest source of imports into Oman after the UAE, Japan, United States and China. The audit will give preferential status to GNH India in the Oman trade market over other suppliers from countries including USA and EU but will also lead the company to become a key player in contributing towards the growth of Indian’s pharma export share to Oman which in 2016 stands at 39.07%. On January 25th, two delegates from Oman Health Ministry visited GNH India’s warehouse in Prabhadevi, Mumbai to audit the company and to inspect its GDP standard. After receiving a positive response from the auditors, GNH India immediately lined up the export of scheduled drugs to Oman and is looking to establish long lasting business relations with the country. GNH India has been trading with Oman for past eight years, leading as largest pharma suppliers to the market for life-saving and orphan drugs. Commenting on this, Dr. Piyush Gupta, Associate Director, GNH India said, “The visit from the official of the Pharmacy and poison board of Oman authenticates and further validates GNH India as a distributor of priority medicines. There is no stone left unturned to ensure that all the measures taken are compliant with international standards. Getting through this audit has opened a new vista for GNH India and has propelled trade relations with Oman in a great way.” GNH India exports to more than 180 countries and has 135,000 product lines to choose from which makes this company one of the leading businesses in the $12.5 billion Indian pharmaceutical export industry. It has recently exported a large non- profit shipment to Somalia to aid the people with basic medicines which are lacking in the country.     ]]> <![CDATA[Samsung India launches 15 health centres in TN]]> https://biospectrumindia.com/news/95/10435/samsung-india-launches-15-health-centres-in-tn.html https://biospectrumindia.com/news/95/10435/samsung-india-launches-15-health-centres-in-tn.html Tue, 20 Feb 2018 11:10:00 +0530 Samsung India and the Tamil Nadu government have launched 15 Samsung Smart Healthcare centres in the state. Chief Minister K. Palaniswami formally launched the centres by inaugurating one such centre at the government hospital at Edappadi in Salem district. A Memorandum of Understanding (MoU) was signed between Samsung India and the State Department of Medical, Health and Family Welfare in November last year. As part of the MoU, Samsung will provide advanced and innovative healthcare equipment such as digital ultrasound and digital x-ray machines manufactured by the company along with LED TVs, air conditioners and refrigerators to selected government hospitals. Samsung Smart Healthcare programme aims to support the government's efforts to benefit communities with limited access to quality healthcare across primary, secondary and tertiary levels. So far, over 3.5 lakh patients from the economically and socially-deprived sections of the society have been benefited at these centres across India. ]]> <![CDATA[Industry leaders from pharma and medical devices sectors raise key demands with the Government]]> https://biospectrumindia.com/news/95/10428/industry-leaders-from-pharma-and-medical-devices-sectors-raise-key-demands-with-the-government.html https://biospectrumindia.com/news/95/10428/industry-leaders-from-pharma-and-medical-devices-sectors-raise-key-demands-with-the-government.html Fri, 16 Feb 2018 18:45:00 +0530 A delegation of key industry leaders from the pharma and medical devices sectors highlighted their pressing demands and concerns to the Union minister of Chemicals & Fertilizers Mr. Ananth Kumar at the third edition of India Pharma and Medical Device 2018 that is being held in Bengaluru from Feb 15-17, 2018. The demands, if met, will give the industries a boost and make India a world leader in the pharmaceuticals and medical devices. Five Key Demands of medical device makers: Continue to adhere to globally harmonized standards (ISO and IEC) for patient safety and development of the sector Medical Devices should be separated from Drugs through a new Act should come up with a medical device policy for inclusive growth of the sector Early decision should be taken on Trade Margin Rationalization Current price control mechanism should be altered to take “Value Based Healthcare” approach, focusing on long term health outcome and innovation While congratulating the Government on implementation of New Medical Devices Rules which will help ease of doing business, eminent Medtech CEOs, including those from leading indigenous manufacturers, asked that ICMED-type India-only standards should be stopped and India must abide by globally harmonized standards like ISO and IEC which will allow Indian firms to export medical devices and ensure safety of Indian patients. The CEOs requested the government to separate medical devices from drugs through a new Act, in accordance with global best practices. They said that the Government's move not to increase import duty is a positive step towards maintaining affordability of the Indian patients in a highly out-of-pocket scenario. “We request that the Government draft a Medical Device Policy for inclusive growth of the sector,” they added, asking for Trade Margin Rationalization to ensure affordable Medical Devices for all and an early decision regarding the matter to end business and strategic uncertainty. The industry leaders requested the Government to alter the current price control mechanism and take the approach of “Value Based Healthcare” by focusing on long term health outcome and innovation. The CEOs said they eagerly await the swift implementation of the Ayushman Bharat insurance schems, as it will give a boost to India’s healthcare infrastructure. The leaders of the pharma industry met the minister and asked for a differentiated GST rate for pharma companies. “The country urgently needs revival of domestic API industry to reduce dependence on imports. The government needs to encourage innovation and ‘Make in india’ to promote Indian manufactured drugs,” the CEOs said. The also asked for rationalization of regulators in the pharma sector and greater transparency in the working of NPPA.  Ten Demands of Pharma Industry: Differentiated GST rate for pharma companies Retrospective pricing for NLEM drugs Relook at pricing of injectables Revival of domestic API industry to reduce dependence on imports Promote Indian-manufactured drugs Rationalization of regulators in pharma sector Greater transparency in NPPA working Address implementation issues in DPCO 2013 Widening of scope of Govt. power to review as per Para 31 of DPLCO 2013 Create level playing field The pharma industry leaders also asked for a relook at the pricing of injectables and retrospective for NLEM drugs (applicable to batches manufactured after 15 days of order issue). They strongly urged the Government to create a level playing field such as in the case of testing fee for products exported to China as compared to Chinese products. A host of dignitaries are present at the mega-event, including the Who’s Who of the pharma and medical devices industry and government officials from India and abroad. Hundreds of delegates, including 50 Hosted Delegates from other nations and over 10,000 business visitors, are attending the event. Over 300 companies and 50 start-ups are showcasing their products. Themed around ‘Affordable, Quality Healthcare, 'the three-day conference has back to back sessions with over 90 industry leaders as speakers. This is the third time that Karnataka is hosting this co-located conference on Medical Device & Pharmaceutical sector. The state pharma industry constitutes 264 manufacturing units, providing direct employment to 25,000 people. Karnataka stands 5th in Pharmaceuticals exports with 40% of its pharma produce being exported overseas. The delegation of CEOs that met the Minister Mr. Ananth Kumar was led by Mr. Sashi Kumar, MD of Phoenix Medical Systems who is Co-Chair, FICCI Medical Device Forum and; Probir Das, MD, Terumo India, who is Chair, FICCI Medical Devices Forum; as well as Mr. S Sridhar, MD of Pfizer India, who is Co-Chair, FICCI Pharma Committee. ]]> <![CDATA[LANXESS supports NGO to provide better education for underprivileged kids ]]> https://biospectrumindia.com/news/95/10427/lanxess-supports-ngo-to-provide-better-education-for-underprivileged-kids-.html https://biospectrumindia.com/news/95/10427/lanxess-supports-ngo-to-provide-better-education-for-underprivileged-kids-.html Fri, 16 Feb 2018 15:55:00 +0530 LANXESS India Private Limited, a subsidiary of leading global specialty chemicals company LANXESS, has continued its association with Teach for India, which promotes the need for quality education throughout the country. The company has committed a sum of EUR 75000 (approx. INR 53 lakhs) per year for Corporate Social Responsibility projects in India. It is a five year commitment to support the not-for-profit organization’s efforts towards providing quality education to under-privileged children. LANXESS relationships with Teach for India will continue to prosper as LANXESS always look forward to extend its supports towards health and education.  Dr. Jacques Perez, Managing Director and Country Representative, LANXESS India Pvt. Ltd. handed over the cheque to Ms. Dimple Gujral, Chief Financial Officer, Teach for India (TFI) at LANXESS House in Thane. LANXESS has supported over 15 TFI fellows (trained teachers on a 2 year full time paid commitment) and over 675 students directly so far. This contribution works as a support for the fellows who volunteer to teach the kids at the municipal schools since they generally have given up their jobs to fulfill these social commitments. LANXESS believes in empowering education and has taken many initiatives in India, in the areas of education, skills training and preserving cultural heritage. Teach for India is a nationwide NGO, that aims to eliminate inequity in education in India. ]]> <![CDATA[GE Healthcare bags The Indian Medical Device Company of the Year award]]> https://biospectrumindia.com/news/95/10426/ge-healthcare-bags-the-indian-medical-device-company-of-the-year-award.html https://biospectrumindia.com/news/95/10426/ge-healthcare-bags-the-indian-medical-device-company-of-the-year-award.html Fri, 16 Feb 2018 15:20:00 +0530 GE Healthcare was announced as the Indian Medical Device Company of the Year 2018 at India’s biggest Global Conference on Pharma Industry and Medical Devices. The ‘India Pharma & India Medical Device 2018’ conference, with the theme - ‘Affordable and Quality Healthcare’, is the 3rd International exhibition and conference on Pharmaceutical & Medical Device sector from 15th-17th February, 2018in Bengaluru. GE Healthcare was conferred the award for strong business performance and robust growth in revenue and exports. Nalinikanth Gollagunta, President and CEO, GE Healthcare, India and South Asia said “We are thrilled that GE Healthcare has been recognized as The Indian Medical Device Company of the Year. This recognition is a reflection of our commitment to bring high-quality affordable medical technologies to solve the pressing healthcare needs of the country.”   ]]> <![CDATA[Need of separate ministry of pharma and medical devices: Ananth Kumar]]> https://biospectrumindia.com/news/95/10424/need-of-separate-ministry-of-pharma-and-medical-devices-ananth-kumar.html https://biospectrumindia.com/news/95/10424/need-of-separate-ministry-of-pharma-and-medical-devices-ananth-kumar.html Fri, 16 Feb 2018 13:05:00 +0530 Union Chemicals and Fertilisers Minister Ananth Kumar announced that the government is looking to bring in a new pharma policy for implementing the proposed healthcare plan across the country in the upcoming months.  After taking views and discussions new dimension has been added in this budget of universal healthcare that also has to be chosen into this pharma policy.  While doing so, we will go for all-round reforms so that ease of doing business and ease of living can go hand in hand, he added.  The big healthcare initiative announced in the budget for 2018-19 seeks to cover 10 crore households requires many verticals infrastructure, human resources along with pharma and medical device products.  According to Mr. Kumar, to fulfill this huge demand have urged the participants of the conclave to ensure implementation of healthcare initiative through Make in India efforts. The moto of the prime minister is to provide quality and affordable healthcare, he added. Pharma and Medical Devices sector will be a major employment provider going forward. "We have global presence and supply pharmaceutical to more than 215 countries and are the third biggest manufacturers. Compared to global growth rate of 5 per cent we are growing at the rate of 15 per cent," Kumar said. The minister pointed out the country needs a separate ministry of pharma and medical devices. "I have been pursuing this. My ministry is pursuing this with the Prime Minister," Kumar said. ]]> <![CDATA[Vetter grabs 3rd position at CLEAN! 2018]]> https://biospectrumindia.com/news/95/10423/vetter-grabs-3rd-position-at-clean-2018.html https://biospectrumindia.com/news/95/10423/vetter-grabs-3rd-position-at-clean-2018.html Fri, 16 Feb 2018 12:00:00 +0530 Vetter is one of the winners of the clean manufacturing award CLEAN! 2018. The company persuaded the independent expert jury of the Fraunhofer Institute for Manufacturing Engineering and Automation (IPA) with its innovative Vetter CleanRoom Technology V-CRT®. The prize was awarded as part of the LOUNGES 2018, an associated trade event in the clean manufacturing sector. V-CRT® is a holistic manufacturing technology developed by Vetter for the safe aseptic filling of injection systems. The innovative approach combines the advantages of isolators with Restricted Access Barrier Systems (RABS) and is based on the idea of fully automated decontamination of the entire cleanroom with hydrogen peroxide (H2O2). The result is the highest possible safety in the prevention of contamination as well as a flexible production process. Following the successful commercial implementation and validation of V-CRT® in 2017, the technology will be used in all cleanrooms at Vetter by 2025. ]]> <![CDATA[Government of India bestows Transasia with ‘India Medical Devices Export Company of the Year’ award ]]> https://biospectrumindia.com/news/95/10416/government-of-india-bestows-transasia-with-india-medical-devices-export-company-of-the-year-award-.html https://biospectrumindia.com/news/95/10416/government-of-india-bestows-transasia-with-india-medical-devices-export-company-of-the-year-award-.html Fri, 16 Feb 2018 09:45:00 +0530 Transasia Bio-Medicals Ltd., India’s Leading In-vitro Diagnostic Company, announced today that it has been conferred the ‘India Medical Devices Export Company of the Year’ award by the Ministry of Chemicals & Fertilizers, Government of India. Mr. Suresh Vazirani, Chairman & Managing Director, Transasia Bio-Medicals Ltd. received the award through the hands of Shri Ananth Kumar, Hon’ble Minister (Chemicals & Fertilizers), Government of India, at the 3rd International Exhibition & Conference on Pharmaceutical & Medical Devices Industry – India Pharma 2018 & India Medical Device 2018 held today at the Bangalore International Exhibition Centre, Bengaluru. Shri Suresh Prabhu, Union Minister of Commerce and Industry, Shri Jagat Prakash Nadda, Hon’ble Union Minister for Health & Family Welfare and other well known dignitaries graced the conference. On receiving the award, Mr. Vazirani remarked, “I am honored to receive this prestigious award and grateful to the Ministry of Chemicals & Fertilizers, Government of India for conferring it on us. I am proud that Transasia is contributing to the growth of the economy through its exports to over 110 countries. With a vision of creating a ‘Healthier and Happier World’, Transasia has been successfully combining world-class technologies from our global subsidiaries with efficient, low cost manufacturing in India to meet the diagnostic needs of India and the other emerging markets.” He further added, “On this note, I would like to thank the Government of India for recognizing medtech as a sunrise sector in its Make in India initiative. India’s products are being recognized worldwide for their quality, reliability and affordability. The recent reforms are giving an impetus to the growth of this sector. Further boosts are welcome.” The award for the ‘India Medical Devices Export Company of the year’ category along with other categories was instituted by the Govt. of India in order to encourage indigenous manufacturing of medical devices.   To this effect, Transasia is the first Indian In-vitro Diagnostic Company to manufacture and export state-of-the-art blood analyzers and reagents, way back in 1990s. Transasia's main focus remains on the emerging countries in Asia, Africa, the Middle East, Latin America and Eastern Europe. In Asia, besides India it caters to the diagnostic needs of countries such as Thailand, Indonesia, Philippines and Vietnam. With over 14 overseas acquisitions in countries as varied as the Czech Republic, Germany, U.K, France, Italy, Russia, Turkey, and the US, Transasia serves millions. The exhibition brought together key decision makers from the realms of the industry, academia, regulators and government to gauge opportunities and estimate the potential of indigenous manufacturing for medical devices in India and thereby create an ecosystem to enable path breaking initiatives and innovations. ]]> <![CDATA[Pfizer gets Breakthrough Therapy designation from FDA to treat atopic dermatitis]]> https://biospectrumindia.com/news/95/10413/pfizer-gets-breakthrough-therapy-designation-from-fda-to-treat-atopic-dermatitis.html https://biospectrumindia.com/news/95/10413/pfizer-gets-breakthrough-therapy-designation-from-fda-to-treat-atopic-dermatitis.html Thu, 15 Feb 2018 14:55:00 +0530 Pfizer Inc. announced its once-daily oral Janus kinase 1 (JAK1) inhibitor PF-04965842 received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) for the treatment of patients with moderate-to-severe atopic dermatitis (AD). The Phase 3 program for PF-04965842 initiated in December and is the first trial in the JAK1 Atopic Dermatitis Efficacy and Safety (JADE) global development program.  Breakthrough Therapy Designation was initiated as part of the Food and Drug Administration Safety and Innovation Act (FDASIA) signed in 2012. PF-04965842 is an oral small molecule that selectively inhibits Janus kinase1. Inhibition of JAK1 is thought to modulate multiple cytokines involved in pathophysiology of AD including interleukin (IL)-4, IL-13, IL-31 and interferon gamma. Pfizer has established a leading kinase research capability with multiple unique kinase inhibitor therapies in development. As a pioneer in JAK science, the Company is advancing several investigational programs with novel selectivity profiles. Achieving Breakthrough Therapy Designation from FDA is an important milestone for Pfizer and patients living with the often devastating impact of moderate-to-severe atopic dermatitis, their providers and caregivers. ]]> <![CDATA[Novartis, Bill & Melinda Gates team up against infectious diarrheal disease]]> https://biospectrumindia.com/news/95/10410/novartis-bill-melinda-gates-team-up-against-infectious-diarrheal-disease.html https://biospectrumindia.com/news/95/10410/novartis-bill-melinda-gates-team-up-against-infectious-diarrheal-disease.html Thu, 15 Feb 2018 11:45:00 +0530 Novartis and the Bill & Melinda Gates Foundation have formed an alliance to advance development of Novartis' drug candidate KDU731 for the treatment of cryptosporidiosis. Diarrheal diseases are one of the leading causes of childhood mortality globally, resulting in approximately 525,000 deaths each year and cryptosporidiosis is the second leading cause of infectious diarrhea in children under 2 years of age. KDU731 is a Cryptosporidium lipid kinase PI(4)K (phosphatidylinositol-4-OH kinase) inhibitor, which has been shown to effectively treat Cryptosporidium infection in preclinical models and is currently undergoing safety studies prior to the initiation of clinical trials. Under the terms of the agreement, the Bill & Melinda Gates Foundation will provide $6.5 million to support the development of this drug candidate for the treatment of children by the Novartis Institute for Tropical Diseases (NITD).  NITD is a Novartis research institute dedicated solely to the discovery and development of new medicines to treat malaria, cryptosporidiosis, and three major kinetoplastid diseases - human African trypanosomiasis (sleeping sickness), chagas disease and leishmaniasis.  ]]> <![CDATA[AVEO receives NICE approval for Fotivda ]]> https://biospectrumindia.com/news/95/10407/aveo-receives-nice-approval-for-fotivda-.html https://biospectrumindia.com/news/95/10407/aveo-receives-nice-approval-for-fotivda-.html Wed, 14 Feb 2018 16:40:00 +0530 AVEO Oncology has announced that the United Kingdom’s National Institute for Health and Care Excellence (NICE) has published a Final Appraisal Determination (FAD) recommending FOTIVDA (tivozanib) for the first line treatment of adult patients with advanced renal cell carcinoma (aRCC). In the European Union, Norway and Iceland, tivozanib is indicated for the first line treatment of adult patients with aRCC and for adult patients who are vascular endothelial growth factor receptor (VEGFR) and mTOR pathway inhibitor naive following disease progression after one prior treatment with cytokine therapy for aRCC. Tivozanib is an oral, once-daily, potent and highly-selective vascular endothelial growth factor receptor tyrosine kinase inhibitor (VEGFR-TKI). EUSA Pharma is the licensee for tivozanib in Europe, North and South Africa, Latin America and Australasia. The positive recommendation triggers a $2M milestone payment to AVEO from EUSA Pharma.  As per the agreement EUSA Pharma will pay up to $386 million to AVEO for future research and development. ]]> <![CDATA[AstraZeneca India launches Xigduo XR tablets for type 2 diabetes management]]> https://biospectrumindia.com/news/95/10402/astrazeneca-india-launches-xigduo-xr-tablets-for-type-2-diabetes-management.html https://biospectrumindia.com/news/95/10402/astrazeneca-india-launches-xigduo-xr-tablets-for-type-2-diabetes-management.html Wed, 14 Feb 2018 15:05:00 +0530 AstraZeneca Pharma India Limited has announced the launch of its innovative anti-diabetic combination once-daily therapy Xigduo XR for treatment of adults with type 2 diabetes. Xigduo XR, is a product of AstraZeneca Group and is approved in 61 countries to date including US, EU & Japan. It combines two anti-diabetic agents with complementary mechanisms of action, the widely recommended first line monotherapy (metformin) with a clinically trusted dapagliflozin, an inhibitor of sodium-glucose cotransporter 2 (SGLT2), in a once-daily oral tablet. This combination backed by the XR (extended release) technology provides 24-hour sugar control offering physicians and patients a new approach to early achievement of treatment goals.  XIGDUO XR is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both dapagliflozin and metformin is appropriate. SGLT2 inhibitors are a relatively new class of medicines that provide comprehensive control through HbA1c reduction, blood pressure control and weight reduction along with clinically proven better cardiovascular outcomes. Earlier in 2015, AstraZeneca India had launched the first CDSCO approved SGLT2 inhibitor in India under the brand name Forxiga (dapagliflozin). Commenting on the launch, Mr. Gagan Singh Bedi, Managing Director, AstraZeneca Pharma India Limited said, “Over 74 million patients are affected by diabetes today and a significant number do not reach their treatment goals. We believe this novel once-daily combination therapy of dapagliflozin and metformin can address an unmet medical need by offering a comprehensive and convenient treatment option for the Indian phenotype patient predisposed to comorbidities such as blood pressure and weight gain. Xigduo XR is an exciting new addition to our diabetes portfolio and signifies our commitment to improve diabetes care through innovative treatment solutions” Eight in ten Indians display a characteristic feature of the Indian Phenotype (greater degree of central body obesity, higher insulin resistance and characteristic dyslipidemia) making them highly vulnerable to developing the nexus of type 2 diabetes, obesity and hypertension. Clinical evidence further reveals that Indian diabetic patients have comorbidities such as hypertension and abdominal obesity and are at two-fold risk of cardiovascular and 40-70% increased risk of renal complications. Xigduo XR’s unique mode of action offers an alternate treatment solution that caters to these complications in Indian diabetic patients. Dr. Anilda Dsouza, Head Medical Affairs, AstraZeneca India said, “Type 2 diabetes is a progressive disease and we are pleased to bring this innovative treatment option for physicians and patients that combines two trusted agents to help intensify the treatment right from the start and has the potential to delay the disease progression” Substantial delays in treatment intensification in patients with type 2 diabetes is an important barrier to optimal patient outcomes. XIGDUO XR acts to significantly lower A1C levels by reducing circulating blood sugar, decreasing the amount of glycated hemoglobin in the body. XIGDUO XR does this through its multi-level action: its metformin component improves insulin sensitivity, increases peripheral glucose uptake and utilization, and reduces glucose production by the liver and its absorption by the intestine; and its dapagliflozin component prevents the kidneys from reabsorbing glucose and helps increase glucose excretion. XIGDUO XR is available in multiple dosage strengths of dapagliflozin and metformin HCl extended-release including 10/500 mg and 10/1000 mg and the starting dose can be individualized based on each patient’s current treatment regimen. It is not recommended for patients with type 1 diabetes mellitus or diabetic ketoacidosis. Xigduo XR joins the family of SGLT2i brands (Forxiga) in AstraZeneca’s strong diabetes portfolio. AstraZeneca offers products in three novel and fast- growing classes of diabetes treatments: DPP4, SGLT-2 and GLP-1. AstraZeneca India has two patented brands-Onglyza (Saxagliptin) and Kombiglyze XR in the DPP4i segment, Bydureon in the GLP1 Analog treatment segment and FORXIGA & XIGDUO XR in the SGLT2i segment. ]]> <![CDATA[Teva launches Qvar Redihaler inhalation aerosol in US market]]> https://biospectrumindia.com/news/95/10404/teva-launches-qvar-redihaler-inhalation-aerosol-in-us-market.html https://biospectrumindia.com/news/95/10404/teva-launches-qvar-redihaler-inhalation-aerosol-in-us-market.html Wed, 14 Feb 2018 15:05:00 +0530 Teva Pharmaceutical’s QVAR RediHaler (beclomethasone dipropionate HFA) Inhalation Aerosol is now commercially available in the market. In the US QVAR RediHaler is the first and only breath-actuated aerosol inhaled corticosteroid. It is used for the treatment of asthma as a prophylactic therapy in patients 4 years of age and older. It is not indicated for the relief of acute bronchospasm.  QVAR RediHaler differs from conventional metered-dose inhalers (MDIs) as it delivers medication via a breath-actuated inhaler, eliminating the need for hand-breath coordination during inhalation. QVAR RediHaler administers the same active ingredient found in the previously available QVAR (beclomethasone dipropionate HFA) Inhalation Aerosol, but utilizes innovative breath-actuated inhaler technology. QVAR RediHaler was also designed to be ready for use, with no shaking or priming needed. Because the medication delivery is breath actuated, it should not be used with a spacer or volume holding chamber. ]]> <![CDATA[Merck launches Viresolve Barrier Capsule Filters]]> https://biospectrumindia.com/news/95/10401/merck-launches-viresolve-barrier-capsule-filters.html https://biospectrumindia.com/news/95/10401/merck-launches-viresolve-barrier-capsule-filters.html Wed, 14 Feb 2018 13:05:00 +0530 Merck, a leading science and technology company, has introduced Viresolve® Barrier capsule filters to reduce the risk of bioreactor contamination. Viresolve® Barrier filters are designed to remove viruses, mycoplasma and bacteria from cell culture media. Viresolve® Barrier filters are a key component of Merck’s Viral Safety Assurance Program to mitigate the risk of viral contamination in upstream bioprocesses and minimizes the potential impact on drug supply and patient safety. The Viral Safety Assurance Program takes a holistic approach to viral safety, offering solutions to prevent viruses from entering upstream processes detect viruses in cells, raw materials and process intermediates and remove viruses in downstream processes.  Scalable from bench through commercial manufacturing, Viresolve® Barrier filters offer high flux and high capacity virus filtration to ensure productivity, without impacting cell culture performance or protein quality attributes. These capsule filters are easy to implement directly in front of the bioreactor or into a media storage container.  The company’s process solution business zone provides the industry’s most comprehensive portfolio of high quality products and services for biopharmaceutical manufacturing. ]]> <![CDATA[Lupin launches generic Kapvay tablets in the US]]> https://biospectrumindia.com/news/95/10394/lupin-launches-generic-kapvay-tablets-in-the-us.html https://biospectrumindia.com/news/95/10394/lupin-launches-generic-kapvay-tablets-in-the-us.html Tue, 13 Feb 2018 15:55:00 +0530 Pharma major Lupin announced the launch of its Clonidine Hydrochloride extended-release tablets, 0.1mg, having received an approval from the United States Food and Drug Administration (FDA) earlier. Lupin’s Clonidine Hydrochloride ER tablets is the generic equivalent of Concordia International Corp’s Kapvay® tablets. It is indicated for the treatment of attention deficit hyperactivity disorder (ADHD) as monotherapy or as adjunctive therapy to stimulant medications. Kapvay® tablets had annual sales of approximately USD 66 million in the US (IQVIA MAT December 2017). ]]> <![CDATA[Lupin receives tentative FDA approval for generic Locoid Lotion]]> https://biospectrumindia.com/news/95/10393/lupin-receives-tentative-fda-approval-for-generic-locoid-lotion.html https://biospectrumindia.com/news/95/10393/lupin-receives-tentative-fda-approval-for-generic-locoid-lotion.html Tue, 13 Feb 2018 15:50:00 +0530 Pharma major Lupin has announced the tentative approval for its Hydrocortisone Butyrate Lotion, 0.1% from the United States Food and Drug Administration (FDA) to market a generic version of Precision Dermatology, Inc.’s Locoid® Lotion, 0.1%. Lupin’s Hydrocortisone Butyrate Lotion, 0.1% is the generic equivalent of Precision Dermatology, Inc.’s Locoid® Lotion, 0.1%. It is indicated for the topical treatment of mild to moderate atopic dermatitis in patients 3 months of age and older. Hydrocortisone Butyrate Lotion, 0.1% had annual sales of approximate USD 16.1millionin the US (IQVIA MAT October 2017). ]]> <![CDATA[Sandoz launches generic version for relapsing forms of multiple sclerosis]]> https://biospectrumindia.com/news/95/10391/sandoz-launches-generic-version-for-relapsing-forms-of-multiple-sclerosis.html https://biospectrumindia.com/news/95/10391/sandoz-launches-generic-version-for-relapsing-forms-of-multiple-sclerosis.html Tue, 13 Feb 2018 13:20:00 +0530 Sandoz, a Novartis division, announced the US FDA approval and launch of Glatopa® (glatiramer acetate injection) 40 mg/mL. Glatopa (glatiramer acetate injection) 40 mg/mL is FDA-approved as a fully substitutable, AP rated generic version of Copaxone® (glatiramer acetate injection) 40 mg/mL three times-a-week therapy for relapsing forms of multiple sclerosis (MS). Glatopa was developed under a collaboration agreement between Momenta Pharmaceuticals, Inc. and Sandoz and is produced in the US.  Glatopa 40 mg/mL is indicated for the treatment of patients with relapsing forms of multiple sclerosis. Glatopa 40 mg/mL, along with Glatopa 20 mg/mL, will offer patients a complete range of dosing options. "The approval and launch of Glatopa 40 mg/mL reinforces our leadership in delivering complex, differentiated generic products. We look forward to bringing this product to patients and healthcare professionals and providing a full range of patient support services for Glatopa through GlatopaCare®," said Richard Francis, CEO, Sandoz. ]]> <![CDATA[Lonza enriches its Cell-Culture techniques with Quasi Vivo System]]> https://biospectrumindia.com/news/95/10390/lonza-enriches-its-cell-culture-techniques-with-quasi-vivo-system.html https://biospectrumindia.com/news/95/10390/lonza-enriches-its-cell-culture-techniques-with-quasi-vivo-system.html Tue, 13 Feb 2018 12:05:00 +0530 Lonza announced the latest addition to its cell-culture product portfolio with the Quasi Vivo® System. The Quasi Vivo® Device consists of an advanced, interconnected fluidics system to create more physiologically relevant cell-culture conditions, helping researchers improve the predictive value of their studies.  This new product offering from Lonza is a result of a worldwide marketing and distribution agreement with Kirkstall (a biotechnology company based in Rotherham, UK).  Kirkstall developed the Quasi Vivo® System, which consists of interconnected cell-culture chambers and a peristaltic pump to create a continuous flow of media over cells. As a result, cultures are exposed to more physiologically relevant conditions, increasing the predictive value of in vitro experiments.  The Quasi Vivo® System is available with three different culture chambers (QV500, QV600, and QV900) to support a wide range of applications, including submerged cell culture, co-culture and modeling of air-liquid and liquid-liquid interfaces. Not only is the Quasi Vivo® System easy to set up, it also enables close monitoring of variables during an experiment. Furthermore, the large scale and user configurability of the Quasi Vivo® System allows assays to be performed that are not possible using microfluidic systems. ]]> <![CDATA[Lupin introduces generic substitute for Tamiflu in US]]> https://biospectrumindia.com/news/95/10387/lupin-introduces-generic-substitute-for-tamiflu-in-us.html https://biospectrumindia.com/news/95/10387/lupin-introduces-generic-substitute-for-tamiflu-in-us.html Tue, 13 Feb 2018 10:55:00 +0530 Pharma major Lupin announced the launch of its Oseltamivir Phosphate Capsules, used for treatment of influenza in the US markets. The company said in a BSE filing that it has launched its tablets after receiving the approval from the United States Food and Drug Administration (USFDA).  Lupin’s Oseltamivir Phosphate Capsules, USP, 30 mg (base), 45 mg (base), and 75 mg (base) are the generic equivalent of Hoffman-La Roche, Inc.’s Tamiflu®Capsules, 30 mg, 45 mg, and 75 mg. Oseltamivir Phosphate Capsules USP, 30 mg (base), 45 mg (base), and 75 mg (base) are indicated for the treatment of acute, uncomplicated influenza A and B in patients 2 weeks of age and older who have been symptomatic for no more than 48 hours, and prophylaxis of influenza A and B in patients 1 year and older. The capsules had annual sales of about US $518 million in the US as per IQVIA MAT December 2017 data ]]> <![CDATA[Medlife.com is the first to launch its line of generic drugs]]> https://biospectrumindia.com/news/95/10381/medlife-com-is-the-first-to-launch-its-line-of-generic-drugs.html https://biospectrumindia.com/news/95/10381/medlife-com-is-the-first-to-launch-its-line-of-generic-drugs.html Mon, 12 Feb 2018 15:40:00 +0530 Medlife.com, India’s fastest growing healthcare company and largest omni-channel pharmacy, is all set to launch its private label generic drugs. A first for any online pharmacy, Medlife’s launch of generic drugs is in keeping with the Government of India’s recent efforts to encourage the use of affordable generic drugs, instead of expensive brand-named alternatives.  As the largest e-pharmacy in India, covering over 80% of the country’s pin-code, Medlife has plans to launch about 30 generic drugs and 40 OTC products by the next financial year. The Bengaluru-based health technology company expects a revenue of INR 100 cr from the private label offering.  A drug master file (DMF) is a confidential, detailed document submitted by Active Pharmaceutical Ingredient (API) manufacturers to the U.S. Food and Drug Administration (FDA).  Currently, it is the non-DMF grade products that is available in the Indian market and that too at a higher cost. Medlife is the first Indian company to use DMF grade material for its pure generic medicines and yet have kept the pricing economical. This is in line with Medlife`s vison to provide quality healthcare while relentlessly driving down the costs to make it more affordable for the people of India. FDA-approved products, like Medlife paracetamol, provide greater assurance of quality and are held to high quality standards compared to products that are not approved by the FDA.  This is going to be a major disruption in the Indian pharma market. With its launch of private label generics, Medlife aims to make quality medicines affordable for Indians. For instance, the company will soon launch reasonably-priced, DMF-grade Paracetamol 650 mg that promises up to 92% drug release within just five minutes, to provide instant relief from fever and pain. The drugs will be manufactured in a WHO-GMP, PICS, HACCP, ISO 22000:2005 certified and approved plant. Speaking about the company’s long-term plans, Tushar Kumar, CEO, Medlife said, “Being on the frontlines of the healthcare sector, pharmacy has the potential to be a real game-changer. Our vision is to develop a comprehensive and ethical healthcare ecosystem that makes healthcare affordable, accessible and responsive to the needs of all Indians. Promotion of generic drugs is a significant step in bringing down healthcare expenses and making medicines easily available to the common man. We need to spread awareness about the promise of pure generics among doctors and patients alike. In line with the Government of India’s push for generic drugs, we believe in its far-reaching benefits, especially in public health. Bringing together the best of technology and robust healthcare delivery system, Medlife is committed to bridging the yawning gaps in India’s healthcare system.” India is the largest provider of generic drugs globally, with the Indian generics accounting for 20 per cent of global exports in terms of volume. By 2020, the Indian pharmaceutical sector is expected to grow to US$ 55 billion, thereby emerging as the sixth largest pharmaceutical market globally. Since its inception as an e-pharmacy company in 2014, Medlife has diversified into 24X7 e-consultation, laboratory services, app-based healthcare-related services, and now, private label generics, to become an integrated healthcare service provider with a pan-India presence. In a short span of just over two years post-launch, Medlife went on to create a customer base of one million unique customers. Backed by promoters with credible experience in pharmaceutical and healthcare e-commerce businesses, Medlife is known for its best-in-class quality, 100% regulatory compliance and zero-delivery error. With a planned internal investment of $30 million to scale up operations, the company expects to earn a revenue of Rs 900-1000 crores by financial year 2019. ]]> <![CDATA[Lonza Pharma, Denali Therapeutics to develop biologic medicines]]> https://biospectrumindia.com/news/95/10382/lonza-pharma-denali-therapeutics-to-develop-biologic-medicines.html https://biospectrumindia.com/news/95/10382/lonza-pharma-denali-therapeutics-to-develop-biologic-medicines.html Mon, 12 Feb 2018 15:40:00 +0530 Lonza Pharma & Biotech and Denali Therapeutics have announced an exclusive strategic partnership on Denali’s biologic pipeline products for neurodegenerative diseases. The agreement covers all stages of the development and manufacturing.  To treat neurodegenerative diseases biologics should be able to cross the tightly controlled blood-brain barrier (BBB). Denali is engineering its biologic product candidates. Through this partnership Denali will have access to Lonza’s extensive expertise and technologies from cell-line development using the GS Xceed Gene Expression System to process development and manufacturing at facilities in Slough (UK) and Hayward, CA (USA). In addition, Lonza’s in-house Drug Product Services in Basel (CH) will focus on ensuring that Denali’s finished product candidates are designed with optimal formulation, stability and delivery system in mind. Denali aims to discover and develop therapies to defeat degeneration, including diseases such as Alzheimer’s, Parkinson’s and ALS. Denali selects its targets based on validated genetic drivers of neurodegeneration, develops molecules that effectively cross the BBB and uses biomarkers to select the right patient population and demonstrate target and pathway engagement in clinical trials. ]]> <![CDATA[Bengaluru to witness India’s biggest global conference on pharma industry and medical devices]]> https://biospectrumindia.com/news/95/10379/bengaluru-to-witness-indias-biggest-global-conference-on-pharma-industry-and-medical-devices.html https://biospectrumindia.com/news/95/10379/bengaluru-to-witness-indias-biggest-global-conference-on-pharma-industry-and-medical-devices.html Mon, 12 Feb 2018 12:25:00 +0530 The third international conference and exhibition on pharmaceuticals industry and medical devices, India Pharma & India Medical Device 2018, will be held at Bengaluru from February 15-17, 2018, by the Federation of Indian Chambers of Commerce and Industry (FICCI) in collaboration with the Dept. of Pharmaceuticals (DoP), Ministry of Chemicals and Fertilizers, Govt. of India. The chosen theme for this year is ‘Affordable, Quality Healthcare.’ Mr. Ananth Kumar, Minister for Chemicals & Fertilizers, Govt. of India, will inaugurate the three-day mega-event and address the distinguished gathering in the presence of dignitaries such as Mr. JP Nadda, Union Health Minister; Mr. Siddaramaiah, Chief Minister, Karnataka; and Mr. Mansukh L Mandaviya, Minister of State for Chemicals & Fertilizers, Govt. of India. India Pharma & India Medical Device 2018 will bring key stakeholders of the pharma and medical devices sectors under one roof, with hundreds of delegates and 50 Hosted Delegates from other nations attending the show. Over 300 companies and 50 startups will showcase their products at the grand exhibition. The event will also see more than 90 eminent industry leaders speak at various sessions lined over three days. More than 20 international drug and device regulators will participate in a meet with Indian regulators. Ministerial delegations from CIS and BIMSTEC countries will also attend the event. A key highlight of India Pharma & India Medical Device 2018 is a workshop by World Health Organization on “Regulatory System Strengthening and Prequalification updated by WHO.” A conference will also be organized by NASSCOM on “Digital Transformation through Innovation in Pharmaceutical, Medical Devices and Healthcare Industries.” The event will see a roundtable of pharma and medical devices CEOs with the Union Minister of Chemicals & Fertilizers, Mr. Ananth Kumar. India Pharma & India Medical Device Awards will be announced to honor excellence and innovation in the field of pharmaceuticals and medical devices. For three days, the event will host sessions build around themes like Discovering Innovative Medicines in India; Making India a Part of Global Supply Chain in Medical Devices; Opportunities, Challenges and Regulatory Requirements in the Development of Biologics; Opportunities & Challenges for Stem cells & Regenerative Medicine; Emerging Global Trends in Self Care and Relevance of OTC Regulatory Framework for Indian Public Healthcare System; a Sub-sectoral Approach to Make in India; and Moving towards API Self Sufficiency. ]]> <![CDATA[Sanofi launches new insulin Toujeo in India]]> https://biospectrumindia.com/news/95/10378/sanofi-launches-new-insulin-toujeo-in-india.html https://biospectrumindia.com/news/95/10378/sanofi-launches-new-insulin-toujeo-in-india.html Mon, 12 Feb 2018 11:40:00 +0530 Sanofi India continues to deliver breakthrough medicines for the management of diabetes with the launch of its new product - Toujeo, the next generation basal insulin. Toujeo is a once-daily, long-acting basal analog insulin that improves glycemic control in adults with type 1 and type 2 diabetes. Low blood sugar, or hypoglycemia is a constant fear amongst people on insulin. Toujeo has demonstrated that it effectively lowers blood glucose, while minimizing the risk of hypoglycemia. It works by slowly releasing small amounts of insulin to provide continuous glucose-lowering activity that lasts beyond 24 hours. With its stable and flat/peak-less action profile, Toujeo reduces glycemic variability, i.e. the daily highs and lows that people with diabetes on insulin may experience. The product also comes with an impressive MY COACH patient support program (offered free to patients prescribed Toujeo).  This patient support program provides six comprehensive months of hand-holding patients through their treatment journey - tips on diet and lifestyle, training on injection techniques, sugar monitoring and more, via a mix of telephonic and in-person sessions. MY COACH will be offered under Sanofi’s Saath-7 initiative, the longest running patient support program in India, which has serviced more than 4,12,000 people with diabetes on insulin till date. Rajaram, Managing Director, Sanofi India, said, “At Sanofi, it is our continuous endeavor to expand our product portfolio and to offer newer healthcare solutions to people in the therapy areas such as Diabetes & Cardiovascular Diseases, Consumer Healthcare, Central Nervous System, Thrombosis, Anti-infectives, to name a few. For over ten years, we have been supporting people with diabetes through an integrated care approach with our comprehensive diabetes management portfolio of differentiated products and services, to help meet their treatment goals. As a health journey partner, Sanofi understands the challenges of people with diabetes. Toujeo is an extension of Sanofi’s continued product innovation and complements the portfolio by maximizing the patient's comfort and safety. The launch of Toujeo reaffirms our strong commitment of expanding Sanofi’s portfolio and to drive better diabetes management in India.” Oral drugs remain the mainstay and first line of treatment for diabetes. However, in time, many people with diabetes find that these drugs alone are not sufficient to control blood sugar and they may eventually need to include insulin as part of their diabetes management. Dr. Mubarak Naqvi, Medical Head of Insulins, Diabetes and Cardiovascular Franchise, GEM Business Unit, Sanofi, said, “Basal insulins are considered the most convenient option for initiating people with diabetes on insulin. Being an ultra-long acting basal insulin, with its action lasting beyond 24 hours, Toujeo not only meets a patient’s basal insulin needs for a whole day, but also reduces blood sugar fluctuations for a smooth and predictable control.  Patients usually fear the risk of hypoglycemia with insulins, but Toujeo has demonstrated a low hypoglycemia inducing risk, both during the night and daytime. Doctors can now confidently prescribe this advanced formulation of insulin for patients to have an optimized insulin experience.” Toujeo was first approved in 2015 in the United States and since then, has been approved in over 65 countries worldwide. Toujeo is a prescription drug and is available in the newly designed SoloSTAR pen. It is a simple and easy to use pre-filled pen and contains 50 per cent more insulin than the Lantus pen (450U in Toujeo SoloSTAR, as compared to 300U in Lantus SoloSTAR). ]]> <![CDATA[TATA to launch 17 cancer care centres in Assam]]> https://biospectrumindia.com/news/95/10371/tata-to-launch-17-cancer-care-centres-in-assam.html https://biospectrumindia.com/news/95/10371/tata-to-launch-17-cancer-care-centres-in-assam.html Fri, 09 Feb 2018 15:45:00 +0530 In Guwahati, Tata Sons chairman Natarajan Chandrasekaran declared that the Tata Group will join hands with Assam government to roll out an elaborate cancer care programme across 15 districts of the state from next year.  Chandrasekaran said that its proposed healthcare initiative will be spread across 15 districts of the state.  The proposed infrastructure footprint comprises 17 centres across the state and it will be able to provide much-needed services starting early next year.  The programme will work in hub-and-spoke model with all the medical colleges acting as the hubs, while the district hospitals will function as diagnosis and day-care centres.  The official also said that a three-tiered model has been conceived with leading oncologists, which would offer different levels of cancer care ranging from complicated procedures to simple diagnostic tests.  The model is centered on the use of technology and task shifting to facilitate operations in remote areas, and patient-centric design principles to provide a good in-hospital experience to the patient and care-giver.  The model will ensure that no patient will have to travel more than a few hours for accessing the full suite of cancer treatment services.  This 3-tier model will be supported by an extensive awareness, screening and early detection programme at the population level. ]]> <![CDATA[USFDA gives nod to Jubilant’s generic version of Symmetrel]]> https://biospectrumindia.com/news/95/10368/usfda-gives-nod-to-jubilants-generic-version-of-symmetrel.html https://biospectrumindia.com/news/95/10368/usfda-gives-nod-to-jubilants-generic-version-of-symmetrel.html Fri, 09 Feb 2018 13:30:00 +0530 Drug firm Jubilant Life Sciences announced that its subsidiary has received final approval from the US health regulator for Amantadine Hydrochloride tablets, an anti-viral and anti-Parkinsons drug. The approved drug, generic version of Symmetrel of Endo, is indicated for the prophylaxis and treatment of signs and symptoms of infection caused by various strains of influenza A virus.  It is also indicated in the treatment of Parkinsonism and drug-induced extrapyramidal reactions. For Amantadine Hydrochloride tablets (100 mg), Jubilant Pharma Ltd, a material wholly owned subsidiary of the company, has received final approval of abbreviated new drug application (ANDA). This is the ninth approval received by the company from the USFDA during the current financial year. As per the company’s statistics, till December 31, 2017, Jubilant Life Sciences had 86 ANDAs for oral solids filed in the US, of which 56 have been approved and 12 injectable filings, of which 10 had been approved. ]]> <![CDATA[Alkem partners with Dong A to launch anti-diabetic drug]]> https://biospectrumindia.com/news/95/10364/alkem-partners-with-dong-a-to-launch-anti-diabetic-drug.html https://biospectrumindia.com/news/95/10364/alkem-partners-with-dong-a-to-launch-anti-diabetic-drug.html Thu, 08 Feb 2018 17:30:00 +0530 Mumbai-based Alkem Pharma is foraying into the antidiabetic drug market in the country through partnership with South Korean drug maker Dong A to launch the latter’s Evogliptin. Alkem is in the process of filing for regulatory approvals, and is expected to launch the drug in six to eight months. Evogliptin has been approved in South Korea and the company is waiting for an approval from the USFDA authorities for its North American launch. Gliptins, or class of DPP4 drug inhibitors, are considered far more effective in controlling blood sugar levels than the previous class of drugs. Evogliptin is a new oral DPP4 inhibitor developed for the treatment of patients with type 2 diabetes inadequately controlled by diet and exercise. ]]> <![CDATA[Stempeutics signs a co-development agreement with Alkem for treating Osteoarthritis]]> https://biospectrumindia.com/news/95/10363/stempeutics-signs-a-co-development-agreement-with-alkem-for-treating-osteoarthritis.html https://biospectrumindia.com/news/95/10363/stempeutics-signs-a-co-development-agreement-with-alkem-for-treating-osteoarthritis.html Thu, 08 Feb 2018 16:55:00 +0530 Osteoarthritis (OA) is a common and debilitating chronic degenerative disease of large joints, especially the hip and knee, characterized by a loss of articular cartilage, subchondral sclerosis, and marginal osteophyte formation. Worldwide, approximately 9.6% of men and 18% of women aged ≥60 years have symptomatic osteoarthritis. Current treatment in early-stage OA includes weight reduction, quadriceps strengthening exercises, non-steroidal anti-inflammatory drugs, intra-articular (IA) glucocorticoid injections, viscosupplements, and bracing. Total joint arthroplasty is the mainstay treatment for end-stage OA of the knee joint, which is often associated with serious and life-threatening complications including increased risk of infection. Currently, cell therapy and tissue engineering-based approaches are being used to address the issue of repair of damaged articular cartilage. Allogeneic MSCs are rapidly emerging as an investigational product for cartilage repair. The anti-inflammatory and immunomodulatory properties of MSCs suggest that these cells can reduce inflammation and pain reduction in the knee. Stempeutics Research, a group company of Manipal Education and Medical Group (MEMG) has announced that it has signed an out-licensing deal with Alkem Laboratories for Stempeucel product for OA indication. Out licensing deal comprises of upfront payment, royalties and various regulatory & sales based milestones payments. Under this agreement, Alkem will get the exclusive marketing rights for Stempeucel in India for Osteoarthritis with Stempeutics manufacturing & supplying the product to Alkem. The product is expected to be available in Indian market by 2020 after undergoing the Phase 3 Clinical trial in India, which is expected to commence in 2018. Earlier Stempeutics had successfully completed a Phase 2 clinical trial in India & the outcomes have been published in the peer-reviewed indexed journal Arthritis Research & Therapy, UK. Phase 2 trial data showed that a single intra articular injection of Stempeucel with 25 million cell dose was well tolerated and had positive effects on long term pain reduction and overall improvement in WOMAC scores which measures Pain, Stiffness and Physical Function of the patient.  Commenting on the tie up with Stempeutics Mr Sandeep Singh, MD of Alkem said, “We are pleased to be associated with Stempeutics and the Manipal Group in bringing the next generation of biologics to address unmet medical needs in India. Stempeucel offers a novel treatment approach to the physicians in India to treat Osteoarthritis Knee and will substantially improve the quality of life of millions of patients suffering from this painful disease.” Speaking about the Stempeutics tie-up, Mr Satyen Manikani, Vice President, Strategy & Business Development of Alkem said “We are very happy to tie-up with Stempeutics because of their strong domain expertise in developing world class stem cell products. Regenerative medicine is a rapidly emerging area of biomedical research with enormous therapeutic potential worldwide. The launch of Stempeucel in partnership with Stempeutics will mark Alkem’s foray into this futuristic segment, further strengthening our Pain management franchise.” Mr. BN Manohar, CEO of Stempeutics said, “Current OA treatments are more symptomatic in nature whereas Stempeucel drug has a potential to address the root cause of the disease. In Phase III trial we are going to administer Stempeucel using ultrasound guidance and use new MRI techniques called T2 mapping to assess the quality of articular cartilage and also to assess the quantitative analyses of articular cartilage. We are extremely happy to collaborate with Alkem in developing Stempeucel for OA treatment”. Speaking on the licensing deal with Alkem, Dr Raviraja, Director Business Development, Stempeutics, said “We are progressing well towards our goal of bringing the first stem cell based product for OA treatment in India in the near future. Allogeneic Stem Cell therapy currently dominates the Global Stem Cells Market with a share of almost 63% compared to the autologous market (37%). The potential for stem cell therapy market in India is approx. US$ 540 million and expected to grow rapidly. While the opportunity is good, it is important that the stem cell therapy is affordable for the common man. Therefore our focus is on to develop innovative production techniques for up scaling and making the product affordable”. ]]> <![CDATA[Cipla ties up with Novartis, J&J to market their products]]> https://biospectrumindia.com/news/95/10362/cipla-ties-up-with-novartis-jj-to-market-their-products.html https://biospectrumindia.com/news/95/10362/cipla-ties-up-with-novartis-jj-to-market-their-products.html Thu, 08 Feb 2018 16:40:00 +0530 India’s third-largest drug maker Cipla has tied up with Swiss drug maker Novartis and US firm Johnson and Johnson to market their anti-diabetic drug Vildagliptin and Canagliflozin, respectively.  Historically known for its respiratory portfolio, Cipla will use its over 10,000 strong sales force to make a dent in this space. The other players who have tied up with Novartis for Vildagliptin are USV Pharma, Emcure, and Abbott. For Cipla, one of the oldest drug makers in the country, it’s a late entry into gliptin space. Gliptins, or class of DPP4 drug inhibitors, are considered far more effective in controlling blood sugar levels than the previous class of drugs. In India, the gliptin market is one of the most competitive with over 160 brands vying for a pie of the 10,000-crore anti-diabetes market. Four gliptin drugs — Sitagliptin, Vildagliptin, Saxagliptin and Teneligliptin — are sub licensed to over 20 drug makers who are engaged in a price war. ]]> <![CDATA[BioAsia 2018: Ireland encourages Indian pharma firms ]]> https://biospectrumindia.com/news/95/10356/bioasia-2018-ireland-encourages-indian-pharma-firms-.html https://biospectrumindia.com/news/95/10356/bioasia-2018-ireland-encourages-indian-pharma-firms-.html Thu, 08 Feb 2018 12:30:00 +0530 Ireland is looking forward to BioAsia 2018, the next in the series of the premier event for life sciences, pharmaceuticals and healthcare sector, to encourage Indian pharma companies. BioAsia will be held in Hyderabad on 22nd February to provide a platform to companies, research institutes, investors and regulators to foster growth and innovation. Ireland is one of the international partners for the event. With an open, globalised economy and only 12.5 percent corporate tax, Ireland is looking at investments from India, especially in hi-tech areas, both for the domestic market and as a gateway to Europe.  The past year has been challenging for Indian generic companies from an export perspective as well. Price erosion, coupled with regulatory activism and protectionism, Brexit and lack of new opportunities in tradition chemistry-based products has significantly impacted export revenues and margins. The insistance of Ireland to encourage Indian firms will be beneficial in the backdrop of Brexit. To maintain their leadership position, Indian pharma companies need to innovate and move up the value chain and many of them are choosing Ireland to do so. Ireland has been a popular destination for the life sciences industry due to the ecosystem developed over a period of 50 years.  Telangana Minister for Industries and IT K.T. Rama Rao said “we found that Ireland has robust life sciences and bio-pharmaceutical ecosystem and is one of the key global destinations for pharmaceuticals”. ]]> <![CDATA[Merck gears up for its 350th Anniversary]]> https://biospectrumindia.com/news/95/10353/merck-gears-up-for-its-350th-anniversary.html https://biospectrumindia.com/news/95/10353/merck-gears-up-for-its-350th-anniversary.html Thu, 08 Feb 2018 11:15:00 +0530 Merck, a leading science and technology company, will celebrate its 350th anniversary this year with customers, partners and employees under the motto "Past. Present. Future." The foundation of Merck was laid in 1668 by the pharmacist Friedrich Jacob Merck for what Merck is today a vibrant, global science and technology company. "350 years, that's an incredible number, especially if you consider everything that has happened in the world of science between 1668 and today. We are proud of the many contributions Merck has made to research and development. And we will also continue to do exactly the same. In other words, we are infinitely curious about what is coming," said Stefan Oschmann, Executive Board Chairman and CEO of Merck. A highlight of the anniversary year will be the "Curious2018 - Future Insight" conference in Darmstadt in mid-July 2018. This will be attended by more than 35 renowned international scientists including five Nobel Prize winners: Joachim Frank (2017, Chemistry), Fraser Stoddart (2016, Chemistry), Bruce Beutler (2011, Medicine), Harald zur Hausen (2008, Medicine), Jean-Marie Lehn (1987, Chemistry). They will be presenting their work and discussing the future of science and technology. Merck is supporting this premiere event as the main sponsor. The speakers will present to an audience of around 1,000 guests from all over the world topics focused on Healthcare,Life Science,Materials & Solutions,chemistry and beyond,digitalization and new forms of collaboration. Many more renowned representatives of the scientific and business communities, among others, will be present at "Curious2018 - Future Insight". Another central event in Merck's anniversary year is the European ceremony on May 3, 2018 in a pavilion especially constructed for the celebrations. Around 900 guests from the worlds of politics and business are invited to this event in Darmstadt. Further regional ceremonies will take place in June in Shanghai, China and in October in Boston, USA. In addition, as part of the European ceremony on May 3, the new Innovation Center will be officially opened. Before Merck celebrates with external customers, partners and representatives of society, a celebration for employees will take place on April 18/19. This is planned for the around 50,000 people working at Merck worldwide and will extend over all continents for 24 hours. To encourage the young researchers, competition under the auspices of German Federal President Frank-Walter Steinmeier, will take place in Darmstadt from May 24 to 27. The "Federal President's Award for Outstanding Work" will be given to the German national finals.  At the the end of the anniversary celebrations in autumn will be an Open Day on September 22, 2018 at global headquarters in Darmstadt. Interested visitors will then have the opportunity to take a look behind the scenes of the science and technology company Merck. ]]> <![CDATA[Lupin’s JV yields positive results for Etanercept clinical trials]]> https://biospectrumindia.com/news/95/10351/lupins-jv-yields-positive-results-for-etanercept-clinical-trials.html https://biospectrumindia.com/news/95/10351/lupins-jv-yields-positive-results-for-etanercept-clinical-trials.html Thu, 08 Feb 2018 10:30:00 +0530 YL Biologics (YLB), a joint venture by drugmaker Lupin and Yoshindo, has successfully completed the late phase clinical studies on a biosimilar version of Etanercept (YLB113). YLB is a joint venture company founded by Yoshindo and Lupin in 2014, which focuses on clinical development, NDA filing and PMDA approval, and sales and marketing of biosimilar drugs in Japan. The global Phase III study of YLB113 was a multinational randomised double-blind controlled trial of 52 weeks on more than 500 patients with rheumatoid arthritis in 11 countries. The study compared YLB113's efficacy and safety directly against Enbrel, the branded version of the biological drug from innovator Amgen which has an estimated $11-billion market. The study was conducted at 110 rheumatology clinics across Japan, Europe and India and included 260 Japanese patients from 62 rheumatology clinics, a scale distinct for a global RA trial in Japan. YLB is in the process of compiling a regulatory dossier for submission to Japanese regulator PMDA for its marketing authorisation. ]]> <![CDATA[ProBioGen and TEVA team up for Human Artificial Lymph Node Technology]]> https://biospectrumindia.com/news/95/10346/probiogen-and-teva-team-up-for-human-artificial-lymph-node-technology.html https://biospectrumindia.com/news/95/10346/probiogen-and-teva-team-up-for-human-artificial-lymph-node-technology.html Wed, 07 Feb 2018 15:00:00 +0530 ProBioGen, a leading specialist for contract development and manufacturing of complex glycoproteins announced the signature of a non-exclusive license agreement on its proprietary human Artificial Lymph Node (HuALN) platform technology with TEVA. The unique human Artificial Lymph Node model was developed by ProBioGen as superior 3D-micro-organoid model for analyzing substance effects on the human immune system in vitro. It is based on a patented, miniaturized and perfused bioreactor for long-term cultivation of immune cells. Human blood-derived dendritic cells, T & B lymphocytes and Mesenchymal Stem Cells (MSC)-derived stromal cells are inoculated into the bioreactors’ 3-dimensional hydrogel matrix which is perfused with cell culture medium and aerated, just as in a real human lymph node. Upon antigen-stimulation the cells’ self-organize into immune-competent micro-organoid structures within the 3D matrix. The perfused bioreactor is typically operated for 4 weeks and thus allows multiple and repeated expositions of the immune cells to the test compounds. Under the terms of the agreement the technology platform will be transferred to TEVA as a predictive tool to assist in the assessment of TEVA’s biopharmaceutical drug candidates. ]]> <![CDATA[Mapmygenome, ThinkGenetic team up to enhance genetic services]]> https://biospectrumindia.com/news/95/10344/mapmygenome-thinkgenetic-team-up-to-enhance-genetic-services.html https://biospectrumindia.com/news/95/10344/mapmygenome-thinkgenetic-team-up-to-enhance-genetic-services.html Wed, 07 Feb 2018 13:00:00 +0530 ThinkGenetic has announced a partnership with Mapmygenome, a leading personal genomics company based in India specializing in clinical genomics and molecular diagnostics focused on preventive healthcare. Through this partnership, ThinkGenetic users from India will be able to connect more easily to resources closer to them. Mapmygenome currently has teams providing genetic services all over India. “We are happy to have the opportunity to provide a streamlined option for our users from India,” explains ThinkGenetic Co-Founder and President, Len Barker. “While we do not provide medical services ourselves and continue to be U.S.-based, we are passionate about offering those living with a genetic condition access to the help they need wherever they are located.” ThinkGenetic regularly receives inquiries from users worldwide with their questions or concerns about living with genetic disorders. If appropriate for answering a question received from a user from India, ThinkGenetic will provide the user with a trusted referral to board certified genetic counselors at Mapmygenome. “ThinkGenetic is a unique platform offering resources for patients on genetic conditions at a scale no one else has,” says Mapmygenome CEO Anu Acharya. “Mapmygenome’s mission is to empower consumers, patients, and physicians with knowledge about genetics and genomics through genetic testing and genetic counseling services. We believe this partnership will empower more patients from India in their quest in finding a solution with our partnership genetic counseling services.” While most of the ThinkGenetic knowledge base is currently written in English and focuses on those in the U.S. and Canada, ThinkGenetic currently has visitors from over 170 countries and aims to increase the focus and reach to meet global needs. This partnership is an important step in fulfilling this. ]]> <![CDATA[Thermo Fisher’s Laboratory Automation Solutions designed to boost productivity ]]> https://biospectrumindia.com/news/95/10343/thermo-fishers-laboratory-automation-solutions-designed-to-boost-productivity-.html https://biospectrumindia.com/news/95/10343/thermo-fishers-laboratory-automation-solutions-designed-to-boost-productivity-.html Wed, 07 Feb 2018 11:25:00 +0530 Thermo Fisher Scientific, the world leader in serving science, announced new laboratory automation technologies designed to streamline workflows, optimize productivity, and speed time to results. The new solutions are on display this week at the 2018 Society for Laboratory Automation and Screening (SLAS) conference, Booth 1105, San Diego Convention Center, California. The new Thermo Scientific inSPIRE vertical modular robotic platform is designed to integrate multiple instruments in an easy-to-use, space-saving solution. It provides intuitive control of all integrated systems, both online and offline, and uses the Thermo Scientific Spinnaker XT robot. As a microplate mover with built-in vision capability, Spinnaker XT can identify potential positional issues and take corrective actions to improve sample safety without interrupting the system’s operation. The platform operates on Thermo Scientific Momentum software, which enables users to define, execute and monitor multiple workflows through a simple yet powerful interface. Designed to address the high throughput needs of pharmaceutical and biotechnology laboratories, the Thermo Scientific Cytomat SkyLine microplate storage and sequential delivery device can hold up to 728 microplates and/or lids in 14-stackers. Providing rapid plate access in less than 12 seconds, its built-in plate sequencer is designed to allow for the safe separation and precise centering of labware for optimal transfer placement. Following use, plates can be loaded back into the system and stored at ambient conditions, eliminating the need for any additional storage. With laboratory space at a premium, an optional plate lift device enables up to 150 mm of transfer position range, allowing flexible placement of the Cytomat SkyLine in laboratory automation systems. For researchers looking to optimize results and accelerate throughput using less time and budget as is needed to develop and program customized systems, Thermo Fisher is introducing a series of automated turnkey workflow-based solutions. The first in a series of systems is a cell-free DNA (cfDNA) extraction device, which combines the Thermo Scientific Spinnaker robot, Thermo Scientific KingFisher Presto purification system and MagMAX Cell-Free DNA Isolation Kit with Analytik Jena’s CyBio FeliX liquid handling system. Leveraging Thermo Fisher’s genomics expertise, this end-to-end solution is easily configurable and expandable, offering a complete sample-to-knowledge workflow for next generation sequencing (NGS), reverse transcription polymerase chain reaction (RT-PCR) and capillary electrophoresis (CE) sequencing applications.  In conjunction with industry and company experts, Thermo Fisher will also host educational tutorials to highlight the latest scientific developments, innovations and applications. ]]> <![CDATA[Oracle Health Sciences Reimagines Clinical Development Technology ]]> https://biospectrumindia.com/news/95/10337/oracle-health-sciences-reimagines-clinical-development-technology-.html https://biospectrumindia.com/news/95/10337/oracle-health-sciences-reimagines-clinical-development-technology-.html Tue, 06 Feb 2018 16:55:00 +0530 Oracle announced the launch of Oracle Health Sciences Clinical One Platform, a cloud-based eClinical environment that is intended to redefine the way technology supports clinical research, during a roadshow in Mumbai. Oracle also announced Clinical One Randomization and Supplies Management. Developing a potentially life-saving drug from a promising molecule to an FDA-approved therapy can take more than a decade and cost billions of dollars due to redundant processes, increasing volumes and variety of patient data, and older technology systems that don’t communicate with one another. Oracle Health Sciences is tackling these issues with its Clinical One Platform, a new cloud-based eClinical solution that will unify clinical development operations and information in a single environment with shared functions and an easy-to-use interface for sites, clinical coordinators and their counterparts. Unlike other products in the market, which are point solutions that address only a single part of the drug development lifecycle or a single area within clinical research, Clinical One Platform is a holistic, unified cloud environment. It is being built from the ground-up to address the needs of the entire drug development lifecycle – everyone and every process required to get a drug to market. The vision for its Clinical One Platform is to bring more drugs to market faster and offer hope for more cures by eliminating redundancies, creating process efficiencies and sharing information—in a way that has never been done before. In addition to unveiling its Clinical One Platform, Oracle also launched its first capability in the new environment, Clinical One Randomization and Supplies Management. Designed with self-service in mind and to eliminate the need for customization, this capability will feature an intuitive user interface, enabling clinical teams to design, validate and deploy a study in days with the click of a button. This enables clinical coordinators to quickly add patients to a trial, collect screening information and ensure eligibility for randomization in record time. Jim Streeter, Global Vice President Life Sciences Product Strategy, Oracle said, “The pharmaceutical industry has been facing challenges in bringing new drugs to the market in a timely manner, while maintaining quality and safety. Clinical operations rely on a collection of point solutions that are residing in silos and creating redundancy in the process. The Oracle Health Sciences Clinical One platform is the only cloud environment built from the ground-up to support the core capabilities required for effective study management throughout the entire clinical development lifecycle – from design and planning, to start-up and conduct, to close-out and post-marketing.” “The aim of launching the Clinic One platform is to enable organisations to accelerate the entire drug development process by eliminating redundancies and creating process efficiencies, while maintaining safety and compliance”, he added. ]]> <![CDATA[Lupin receives FDA approval for generic Temovate Cream, 0.05%]]> https://biospectrumindia.com/news/95/10334/lupin-receives-fda-approval-for-generic-temovate-cream-0-05.html https://biospectrumindia.com/news/95/10334/lupin-receives-fda-approval-for-generic-temovate-cream-0-05.html Tue, 06 Feb 2018 15:55:00 +0530 Pharma major Lupin has announced that it has received final approval for its Clobetasol Propionate Cream USP, 0.05% from the United States Food and Drug Administration (FDA) to market a generic version of Fougera Pharmaceuticals Inc.’s Temovate Cream, 0.05%. Lupin’s Clobetasol Propionate Cream USP, 0.05% is the generic equivalent of Fougera Pharmaceuticals Inc.’s Temovate Cream, 0.05%. It is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid responsive dermatoses. Clobetasol Propionate Cream USP, 0.05% had annual sales of approximately USD 135 million in the US. (IQVIA, erstwhile IMS, MAT October 2017) ]]> <![CDATA[Admedus launches adapt® technology in India]]> https://biospectrumindia.com/news/95/10331/admedus-launches-adapt-technology-in-india.html https://biospectrumindia.com/news/95/10331/admedus-launches-adapt-technology-in-india.html Tue, 06 Feb 2018 15:10:00 +0530 In a significant development for Indian patients requiring treatment for structural or congenital heart disease and defects, Admedus Limited in partnership with Syncronei Medical India Pvt Ltd, and supported by the Australian Trade and Investment Commission (Austrade) has introduced its ground-breaking and clinically-superior ADAPT® technology in India. Physicians in India can now access the transformative power and significant patient benefits of ADAPT® engineered tissue and Admedus’ flagship product CardioCel® which is a bio-scaffold for the management of congenital and adult structural heart abnormalities. Wayne Paterson, CEO, Admedus said, “In a country with approximately 50 million cardiac patients and 280,000 babies born annually with a Congenital Heart Defect (CHD), the introduction of our disruptive ADAPT® technology is a significant opportunity for India’s physicians to provide life-changing outcomes for their patients. CardioCel® has been available in North America and Europe for some time but this is the first time Indian physicians and patients have had access to Admedus’ world-class ADAPT® technology,” he said. Primarily used in restorative structural heart repair and reconstruction, ADAPT® treated tissue provides unparalleled resistance to calcification, delivering transformative repair with long-term durability that enables native cells to successfully grow and differentiate through the entire repair, without calcification or toxicity. “Our clinically superior ADAPT® products, invented and manufactured in our state-of-the-art manufacturing facility in Australia, are the only ones to have achieved nine years without calcification or degradation, providing Indian surgeons with a potential lifetime solution for their patients,” Paterson said. To support the launch of CardioCel® in India, ADAPT® inventor and Admedus Vice President of Cardiovascular Technologies Professor Leon Neethling will deliver a comprehensive series of meetings and presentations with physicians in major health centres across India to demonstrate the product’s clinical applications and benefits. The official launch activities follow the announcement of 22 November 2017 that Admedus had received regulatory approval to launch our CardioCel® product in the Republic of India, with Syncronei Medical India Pvt Ltd appointed as exclusive commercial partner managing all sales, marketing and distribution.   ]]> <![CDATA[IHH Healthcare, Temasek looking to buy majority stake in India’s Medanta]]> https://biospectrumindia.com/news/95/10330/ihh-healthcare-temasek-looking-to-buy-majority-stake-in-indias-medanta.html https://biospectrumindia.com/news/95/10330/ihh-healthcare-temasek-looking-to-buy-majority-stake-in-indias-medanta.html Tue, 06 Feb 2018 14:45:00 +0530 Malaysia's IHH Healthcare Berhad and Singapore investor Temasek Holdings are in separate discussions to acquire controlling interest in Global Health, the parent of Naresh Trehan-founded Medanta hospitals, in a deal valued at around Rs 5,800 crore ($900 million).  IHH Healthcare, the world's second-largest hospital chain by market value, is keen on becoming a strategic partner to Trehan, a well-known cardiovascular surgeon turned medical entrepreneur, who will retain significant minority ownership. IHH is attempting to string together shares held by Carlyle, Temasek and the founding partners of Trehan all of which would give the acquirer majority shares. Private equity investor Carlyle and Singapore state investor Temasek together own about 45% stake, leaving the remaining 55% with Trehan's family and other promoters, including co-founder Sunil Sachdeva.  However, Temasek in recent weeks has stepped into the fray, looking to buy out investors who are in exit mode. Temasek has been keen on acquiring a large private healthcare services provider in Asia's third-largest economy. Medanta operates more than 1,600 beds, mostly from its large Gurgaon facility spread over 43 acres. Besides a few shareholders seeking exit, the company also needs fresh capital to expand footprint in newer markets such as Lucknow, Indore and Ranchi. Sources mentioned earlier in this report said IHH was actively pursuing a deal with Medanta after its proposed acquisition of Fortis Healthcare suffered setbacks. IHH was also eyeing a deal with Max Healthcare, in which South African partner Life Care is selling 50% ownership. IHH is seeking to expand its footprint into northern states after gaining foothold in the west and south following the acquisition of Global Hospitals for $194 million three years ago. ]]> <![CDATA[LANXESS extends partnership with Novozymes]]> https://biospectrumindia.com/news/95/10324/lanxess-extends-partnership-with-novozymes.html https://biospectrumindia.com/news/95/10324/lanxess-extends-partnership-with-novozymes.html Mon, 05 Feb 2018 18:15:00 +0530 Leading specialty Chemicals Company LANXESS and Novozymes, a global biotechnology company, have renewed their global engagement of the existing strategic partnership. The two organizations will continue to cooperate on existing enzyme solutions and joint innovations for future enzyme technologies to enhance sustainable production concepts in the leather industry.  X-Zyme® is the outcome of an exclusive partnership between LANXESS and Novozymes. Novozymes’ leading-edge knowhow in enzyme technology research is ideally matched by LANXESS’ long-term global expertise in the development of leather-making processes. The enzymes involved were meticulously selected and developed by using protein engineering and advanced robotic, high-throughput screening to obtain the desired characteristics. Since they are produced by microbial fermentation, the highest levels of purity, quality, consistency, and specificity in use are ensured. In addition, LANXESS has deployed its process know-how to ensure that the enzymes can be successfully employed under real-life beamhouse production conditions. This excellent combination of enzyme development expertise and beamhouse process know-how guarantees a high degree of process stability. This brings together the best of both worlds in the industry; leather chemicals & applications knowhow from LANXESS combined with leading enzyme technology from Novozymes. ]]> <![CDATA[MedGenome Expands Its NGS Capabilities in research]]> https://biospectrumindia.com/news/95/10314/medgenome-expands-its-ngs-capabilities-in-research.html https://biospectrumindia.com/news/95/10314/medgenome-expands-its-ngs-capabilities-in-research.html Fri, 02 Feb 2018 18:35:00 +0530 MedGenome has expanded its capacity at its Foster City, Calif., headquarters laboratory, adding HiSeqX and NovaSeq 6000 platforms to meet the rising demands for Next Generation Sequencing (NGS) in research and clinical settings. The new additions increase MedGenome's data-generation capability by a factor of five. Additionally, availability of a wide range of sequencing platforms gives MedGenome the flexibility to provide customized services at scale, thousands of whole genomes a month and deliver high quality data quickly at a competitive price. The NGS lab has also added sample processing automation from Agilent to support the sequencing capacity.  To capture the power of single cell sequencing, MedGenome has started the Chromium™ Genome Solution from 10X Genomics, for use in multiple applications, including whole-genome phasing and structural-variant analysis, de novo genome assembly, remapping of difficult regions of the genome, and dynamic gene expression of single cells. The new platform allows deconstruction of complex tissue microenvironments at single cell resolution, which enables biomarker discoveries in the area of cancer immunotherapy.  ]]> <![CDATA[Dr. Reddy's announces the launch of Tetrabenazine Tablets in U.S. Market]]> https://biospectrumindia.com/news/95/10310/dr-reddys-announces-the-launch-of-tetrabenazine-tablets-in-u-s-market.html https://biospectrumindia.com/news/95/10310/dr-reddys-announces-the-launch-of-tetrabenazine-tablets-in-u-s-market.html Fri, 02 Feb 2018 12:50:00 +0530 Dr. Reddy’s Laboratories Ltd has announced the launch of Tetrabenazine Tablets, a therapeutic equivalent generic version of Xenazine (tetrabenazine) in the United States market approved by the U.S. Food and Drug Administration (USFDA). The Xenazine brand and generic had U.S. sales of approximately $322 million MAT for the most recent twelve months ending in November 2017 according to IMS Health. Dr. Reddy’s Tetrabenazine Tablets are available in strengths of 12.5 mg and 25 mg, each strength is available in a bottle count size of 112. Xenazine is a registered trademark of Valeant Pharmaceuticals Luxembourg S.A.R.L. ]]> <![CDATA[Thermo Fisher Scientific gets awarded with Manufacturing Leaders’ Innovation Award]]> https://biospectrumindia.com/news/95/10304/thermo-fisher-scientific-gets-awarded-with-manufacturing-leaders-innovation-award.html https://biospectrumindia.com/news/95/10304/thermo-fisher-scientific-gets-awarded-with-manufacturing-leaders-innovation-award.html Fri, 02 Feb 2018 11:30:00 +0530 InSight wireless cold storage monitoring solution by Thermo Scientific has been awarded with the 2017 Manufacturing Leaders’ Innovation Award recently. The InSight wireless monitoring system features advanced analytics and remote diagnostics to protect valuable samples, and avoid costly repairs and equipment failures by proactively identifying issues. By moving from a ‘fail and fix’ method of equipment maintenance to a ‘predict and prevent’ method, customers can gain better insight into the overall health of a unit over time instead of having to wait for an issue to arise. Accepting the award was Sung-Dae Hong, vice president and general manager, Laboratory Equipment Technologies, Thermo Fisher Scientific said, “The annual Manufacturing Leaders’ Innovation Award provides a platform that enables the scientific community to recognize products developed by successfully integrating new technologies, such as sensor networks, Internet of things (IOT), advanced robotics and 3D printing. We are honored to receive this award in recognition of the positive impact that the InSight system has on improving laboratory processes, maximizing system uptime and enhancing productivity.” This system is designed to allow laboratories to proactively monitor the operation of cold storage equipment, anticipating system failure and maintenance needs, and triggering necessary corrective actions. Using Wi-Fi or proprietary wireless protocols, the system continuously collects and analyzes data for parameters such as cabinet temperature, energy consumption, door openings and ambient temperature. It automatically issues alerts to users’ email and mobile devices when set point breaches are detected. In response, laboratory managers can make knowledge-based service and support or service vs. buy decisions. Overall, system downtime is minimized, giving researchers peace of mind that their work is protected at all times. This system can enable the labs to keep their units running optimally and consuming less energy, thereby minimizing their environmental footprint while reducing operating costs. ]]> <![CDATA[ZIM Laboratories develops oral soluble strips]]> https://biospectrumindia.com/news/95/10301/zim-laboratories-develops-oral-soluble-strips.html https://biospectrumindia.com/news/95/10301/zim-laboratories-develops-oral-soluble-strips.html Thu, 01 Feb 2018 15:20:00 +0530 Nagpur-based ZIM Laboratories that develops and manufactures innovative and differentiated pharmaceutical products, has now developed affordable orally disintegrating strips (ODS) formulations up to 100 milligram that critically ill and bed-ridden patients can consume instead of swallowing tablets and taking painful injections. These films, based on a patented oral thin film technology, adhere to the tongue mucosa and disintegrate almost instantaneously, when placed on the tongue.  Market opportunity for the drug is huge in the country, as about Rs. 35,000 crore worth of drugs are delivered every year in oral solid dosage forms.  Moreover, the company, in association with a leading pharmaceutical company, will soon launch multi-layer orally soluble thin films that can carry dosages above 100 milligrams. ZIM Labs is in advanced stages of further researching the product to launch thin films with fixed-dose combinations and liquid drugs, 3D printed tablets for personalised medicines and nanofiber based complex generics. ]]> <![CDATA[Ardigen achieved second place in the DREAM-Proteogenomics Challenge]]> https://biospectrumindia.com/news/95/10282/ardigen-achieved-second-place-in-the-dream-proteogenomics-challenge.html https://biospectrumindia.com/news/95/10282/ardigen-achieved-second-place-in-the-dream-proteogenomics-challenge.html Tue, 30 Jan 2018 15:10:00 +0530 Ardigen, a leading Polish company in bioinformatics & AI for precision medicine, proves its excellence in AI by winning the 2nd place in the prestigious NCI-CPTAC DREAM-Proteogenomics Challenge. The competition gathered more than 500 participants from leading research institutions and universities including Stanford and Harvard. Ardigen joins forces with other top performing teams to further improve understanding of cancerogenesis.  The key components of the Challenge are the novel proteogenomic data measured by the Clinical Proteomic Tumor Analysis Consortium (CPTAC). In order to draw meaningful conclusions from such a complex dataset one needs to combine knowledge in molecular biology with that in statistical learning.  Ardigen AI Labs supports bioinformatics projects in providing state of the art AI and data science solutions. Close collaboration of data scientists with experts in cancer biology, immunology, microbiome, or central nervous system gives the synergy effect and results in competitive edge. ]]> <![CDATA[Lumenis India Organises Master Classes in Urology at USICON 2018]]> https://biospectrumindia.com/news/95/10278/lumenis-india-organises-master-classes-in-urology-at-usicon-2018.html https://biospectrumindia.com/news/95/10278/lumenis-india-organises-master-classes-in-urology-at-usicon-2018.html Tue, 30 Jan 2018 12:20:00 +0530 Medical device company Lumenis Ltd recently organised the ‘Meet the Experts’ exclusive master classes at USICON event in Jaipur. The master classes organised by Lumenis were specially designed to provide training to doctors practicing in the field of Urologic stones management and Enlarged prostate management. Various eminent Urologists and Key Opinion Leaders  conducted knowledge enhancement sessions using breakthrough technologies MOSES P120 and Pulse 100H which are used for Urologic stone management & enlarged prostate. On the occasion, Rashid Mokhdoomi, Senior Director Marketing, Lumenis India & South Asia, said “We take pride to conduct Master Class training sessions for the Urologists,  that came from all over India to attend USICON. This was an excellent platform where various training sessions about our path breaking technologies MOSES P120 and Pulse 100H have kept doctors abreast of latest advancements in the field of Urology treatments. Such sessions enable doctors to enhance their laser procedure techniques and perform procedures in a more convenient and controlled way.” Dr Mahesh Desai, Sr. Consultant, Urologist, said “It was a great honour to be part of the initiative taken by Lumenis where they organized master classes on newest technology introduced in the field of medical sciences. MOSES P120 technology is a path breaking pulse delivery technology which remarkably improves energy transmission and overcoming energy reduction in working distances.” Dr. Anil Varshney, Urologist, said “We are thankful to Lumenis for conducting Master Classes on HOLEP using Lumenis Pulse 100H at USICON . Pulse 100H is a highly versatile & powerful technology for effective HOLEP procedures. Using this breakthrough technology, doctors can perform procedures with the best of outcome.” On this occasion, Navkaran Singh Chimni, Senior Director (Medical Business), Lumenis India & South Asia, felicitated the doctors to honour their contribution in the event.     MOSES P120 technology by Lumenis significantly reduces retropulsion during lithotripsy and minimises stone migration resulting in better control. The Urological Society of India (USICON 2018) was organized under the aegis of The Urological Society of India and Jaipur Urology Society. The annual USICON 2018 focused on latest advances in urology and offers a platform to keep abreast with cutting edge technology in the world of lasers.         ]]> <![CDATA[Mylan, Biocon receive positive CHMP opinion for Semglee]]> https://biospectrumindia.com/news/95/10277/mylan-biocon-receive-positive-chmp-opinion-for-semglee.html https://biospectrumindia.com/news/95/10277/mylan-biocon-receive-positive-chmp-opinion-for-semglee.html Tue, 30 Jan 2018 11:00:00 +0530 Mylan and Biocon Ltd. have announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending approval of Semglee, insulin glargine, a long-acting insulin analog used in the treatment of diabetes mellitus in adults, adolescents and children aged 2 years and above. The CHMP positive opinion will be considered by the European Commission. The European Commission decision on the approval is expected in April. Mylan President Rajiv Malik commented, “We are pleased with CHMP’s decision to recommend approval of Mylan and Biocon’s biosimilar insulin glargine. With approximately 60 million people living with diabetes in the European Region and prevalence on the rise, we have an important role to play to help increase access to high-quality, more affordable treatment options for patients. Mylan is a global leader in the development and manufacturing of complex products, and we are proud of our regulatory, clinical and scientific capabilities that have allowed us to reach this important milestone.”  Arun Chandavarkar, CEO and Joint Managing Director, Biocon said, “CHMP’s decision to recommend approval of Biocon and Mylan’s biosimilar insulin glargine brings us a step closer to offer high quality, affordable options for people with diabetes in the EU.  This is an outcome of our commitment to be a credible, global insulins player on the back of significant investments together with our partner Mylan in global scale manufacturing and R&D after having previously obtained approvals for our insulin glargine in Japan and key emerging markets." Data submitted as part of the Marketing Authorization Application included analytical similarity data, metabolic assays, euglycemic clamp data in type 1 diabetes patients for demonstration of similar PD and PK response, as well as robust clinical endpoint studies in patients with Type 1 and Type 2 Diabetes comparing Semglee with the reference product, insulin glargine to demonstrate similar safety, efficacy and immunogenicity up to 52 weeks. In addition to the European submission, marketing applications for Semglee have been submitted in Australia, Canada, and the U.S. and are planned for key Emerging Markets. Biocon and Mylan are exclusive partners on a broad portfolio of biosimilars and insulin analogs. Glargine is one of the three insulin analogs being co-developed by Mylan and Biocon for the global marketplace. Mylan has exclusive commercialization rights for insulin glargine in the U.S., Canada, Australia, New Zealand, the European Union and European Free Trade Association countries. Biocon has exclusive rights for Japan and a few emerging markets, and co-exclusive commercialization rights with Mylan in the rest of the world. ]]> <![CDATA[Araclon & TFS to continue partnership, advancing Alzheimer’s vaccine to Phase II]]> https://biospectrumindia.com/news/95/10271/araclon-tfs-to-continue-partnership-advancing-alzheimers-vaccine-to-phase-ii.html https://biospectrumindia.com/news/95/10271/araclon-tfs-to-continue-partnership-advancing-alzheimers-vaccine-to-phase-ii.html Mon, 29 Jan 2018 15:10:00 +0530 After completion of Phase I, Araclon Biotech extending the partnership with TFS, advancing their Alzheimer’s disease (AD) vaccine ABvac40 into phase II.  The placebo-controlled phase II trial will be carried out at 21 clinical investigational sites across Europe over the next two years.  AD is a progressive disease associated with the accumulation, aggregation, and deposition of amyloid beta (Abeta) peptides in the brain.  ABvac40 is an innovative, active immunotherapy that uses the C-terminal fragment of the amyloid-beta 40 peptide as an immunogen.  This is a different approach to other AD vaccines, because the immunogen peptide of ABvac40 (Aβx-40) seems to be more relevant to the development of the disease than other peptides targeted by other vaccines. In the phase I study, the vaccine demonstrated a good safety and tolerability profile and produced an immune response in a high percentage of patients. In the phase II for ABvac40, of the 120 participants, some will have amnestic mild cognitive impairment (MCI) and some will have very mild AD, in order to evaluate the efficacy and safety at early stages of the disease, both at the cognitive and molecular levels. ]]> <![CDATA[Strides Shasun, Cipla receive FDA approval for HIV drug]]> https://biospectrumindia.com/news/95/10269/strides-shasun-cipla-receive-fda-approval-for-hiv-drug.html https://biospectrumindia.com/news/95/10269/strides-shasun-cipla-receive-fda-approval-for-hiv-drug.html Mon, 29 Jan 2018 14:45:00 +0530 The wholly owned subsidiary of Strides Shasun and Cipla have obtained the final approval from the US Food and Drug Administration Drug (USFDA) for tenofovir disoproxil fumarate tablets, used for the treatment of HIV-1 infections in adults. This is a generic version of Gilead Sciences' Viread Tablets, 300mg which is indicated in combination with other antiretroviral (ARV) agents for the treatment of HIV-1 infection in adults. The final approval means that product is available for immediate commercialization in the US. Strides Shasun will be launching the product immediately, as the company already had a tentative approval for the product from the USFDA. As per the reports, the US market for tenofovir disoproxil fumarate tablets is approximately $750 million. ]]> <![CDATA[Angiex honored with a Golden Ticket at LabCentral]]> https://biospectrumindia.com/news/95/10265/angiex-honored-with-a-golden-ticket-at-labcentral.html https://biospectrumindia.com/news/95/10265/angiex-honored-with-a-golden-ticket-at-labcentral.html Mon, 29 Jan 2018 12:50:00 +0530 Agilent Technologies Inc. has announced that biotech startup Angiex, Inc., has been awarded an Agilent Golden Ticket at LabCentral, providing funding of one lab bench space for a year.  Three semi-finalists presented their proposals at LabCentral’s Cambridge, Massachusetts, facility on Jan. 22, 2017. The winner was chosen by a panel of judges consisting of Johannes Fruehauf, M.D., Ph.D., cofounder and president, LabCentral; Darlene Solomon, Ph.D., senior vice president and chief technology officer, Agilent; and John Gavenonis, vice president and general manager, Chemistries Division, Agilent CrossLab Group. “All the semi-finalists in our Golden Ticket Event exhibited strong entrepreneurship, innovative scientific approaches, and great promise to advance healthcare. Angiex, our first-place winner, demonstrated an excellent combination of scientific impact, enthusiasm to collaborate with Agilent, and personal drive to advancing cancer treatments,” said Darlene Solomon, senior vice president and chief technology officer for Agilent. Angiex was founded by world-class scientists to develop vascular-targeted biotherapeutics. The main product of Angiex’s is an antibody-drug conjugate therapy for cancer. Agilent as a platinum sponsor has equipped LabCentral's shared laboratory workspace with a variety of Agilent technology, including a high-resolution mass spectrometry system, and a cell analysis extracellular flux (XF) analyzer. The sponsorship also includes a Golden Ticket which represents one year of bench space for a scientist, including benefit of LabCentral's shared infrastructure and services. ]]> <![CDATA[Novartis to expand Hyderabad research facility]]> https://biospectrumindia.com/news/95/10261/novartis-to-expand-hyderabad-research-facility.html https://biospectrumindia.com/news/95/10261/novartis-to-expand-hyderabad-research-facility.html Thu, 25 Jan 2018 19:50:00 +0530 Novartis is most likely to expand operations at its Hyderabad R&D centre. The pharma major currently operates a research and development centre along with data support and analytics from its Hyderabad facility. The current footprint is about 90,000 square feet of laboratory space employing about 350 scientific researchers. The company will be expanding to 1,62,000 sft to establish its High Potent Formulation Development labs along with an Analytical Development Facility which will facilitate 150 more scientific researchers. The issue recently came up for a discussion at the World Economic Forum. Hyderabad has already earned the reputation of being the life sciences capital of the country and establishment of pharma city would give a major push to the sector in the coming days. It is expected that the expansion of the Novartis R&D Centre will significantly boost the development of Genome Valley. ]]> <![CDATA[USFDA gives nod to more than 300 Indian pharma industries]]> https://biospectrumindia.com/news/95/10259/usfda-gives-nod-to-more-than-300-indian-pharma-industries.html https://biospectrumindia.com/news/95/10259/usfda-gives-nod-to-more-than-300-indian-pharma-industries.html Thu, 25 Jan 2018 17:10:00 +0530 Domestic pharma companies received more than 300 approvals in 2017 to launch generic drugs in the US, which is an all-time high. The clearances came despite regulatory pressure from the US Food and Drug Administration (FDA), and unprecedented warning letters issued to the pharma companies' facilities. The final approvals for Indian players are up by nearly 43% from 211 in 2016, and corner about 40% of all global filings in the highly lucrative around $70-billion US market.  The US generics market, a key driver of Indian pharma's growth, has always been a dynamic market. But the pace of change has accelerated in the last few years. The increase in competition and consolidation of distribution channels have led to the US generics business getting commoditised. Price erosion has been at an all-time high and this has impacted operating margins significantly. Major domestic companies earn at least 40% of their overall sales from the US.  To maximise margins, companies are now launching complex generics and speciality products. ]]> <![CDATA[Navitas Life Science at the 11th Indian Society for Clinical Research (ISCR) Annual Conference, Bangaluru]]> https://biospectrumindia.com/news/95/10253/navitas-life-science-at-the-11th-indian-society-for-clinical-research-iscr-annual-conference-bangaluru.html https://biospectrumindia.com/news/95/10253/navitas-life-science-at-the-11th-indian-society-for-clinical-research-iscr-annual-conference-bangaluru.html Wed, 24 Jan 2018 17:15:00 +0530 In 11th Indian Society for Clinical Research (ISCR) an Annual Conference themed “Collaborative Clinical Research for better Patient outcomes” was held in Bangaluru from 19 - 20 January 2018. Navitas Life Sciences (brand of Take Solutions) as a Gold Sponsor participated in the conference. The two-day event, preceded by pre-conference workshops, saw over 800 clinical research professionals from across the globe deliberate on the collaborative role required of clinical research stakeholders in a strengthened and improved clinical research regulatory environment. On behalf of the global Navitas Life Sciences team, Ram Yeleswarapu, President of TAKE Solutions thanked ISCR for this fantastic opportunity. He was also grateful to have experience to know about clinical research development, innovations, new found mechanisms and investments that are happening around the world. Navitas Life Sciences helps biopharmaceutical companies address their most critical problems by bringing together the capabilities of a full-service CRO, a technology-led life sciences services provider across clinical, regulatory and safety, and a life sciences big data services and analytics provider. Navitas Life Sciences has delivered 330+ Phase II-III Clinical studies and over 400 Non-Interventional Studies across multiple therapeutic areas including Oncology, Endocrinology, Metabolic, Ophthalmology, Cardiovascular, Respiratory, Dermatology, Neurology, etc.  Navitas’ clinical trials capabilities are improved by OneClinical, an optimized eClinical and Analytics platform that offers comprehensive trial oversight. ]]> <![CDATA[Equashield’s revenue rose up in U. S. and international market]]> https://biospectrumindia.com/news/95/10250/equashields-revenue-rose-up-in-u-s-and-international-market.html https://biospectrumindia.com/news/95/10250/equashields-revenue-rose-up-in-u-s-and-international-market.html Wed, 24 Jan 2018 15:20:00 +0530 Equashield is a leading provider of Closed System Transfer Devices (CSTDs) for hazardous drugs.  The company discloses its 2017 growth results, including a 42 percent year-over-year increase in revenues. In addition, the company projects a higher growth rate in 2018, driven in part by the company's newly introduced hazardous drug compounding robot.  Equashield's customer base continues to expand, with 60 percent of new customers transitioning away from competing systems to Equashield's CSTD, while 40 percent of customers are introducing CSTDs into their hazardous drug handling practice for the first time. At the end of 2017, over 1,000 sites were using Equashield's closed system, including major hospital systems and NCI and NCCN facilities dedicated to cancer care. Equashield also expanded into new markets internationally in 2017, including Singapore, Hong Kong, Greece, Portugal, Spain, Germany, and the United Kingdom.  ]]> <![CDATA[Torrent Pharma acquires Bio-Pharm]]> https://biospectrumindia.com/news/95/10223/torrent-pharma-acquires-bio-pharm.html https://biospectrumindia.com/news/95/10223/torrent-pharma-acquires-bio-pharm.html Fri, 19 Jan 2018 10:15:00 +0530 US based drugmaker Bio-Pharma has been acquired by Ahmedabad based Torrent Pharmaceuticals. This acquisition is an important step for increasing Torrent’s presence in the United States, is consistent with their strategy of dosage form diversification. Bio-Pharm, Inc. has a 75,000 sqft manufacturing facility, and boasts of 10 abbreviated new drug applications (ANDAs) already approved by the US Food and Drug Administration (FDA).  This is the third acquisition for Torrent Pharma in the last three years. Last year it had acquired India business of Unichem to strengthen its presence in the domestic market. Torrent Pharma plans further investments to expand the Bio-Pharma facilities, including its research and development (R&D) capabilities, and increase the number of product filings from Bio-Pharma. ]]> <![CDATA[Biocon collaborates with Sandoz for Next Generation Biosimilars]]> https://biospectrumindia.com/news/95/10219/biocon-collaborates-with-sandoz-for-next-generation-biosimilars.html https://biospectrumindia.com/news/95/10219/biocon-collaborates-with-sandoz-for-next-generation-biosimilars.html Thu, 18 Jan 2018 20:10:00 +0530 Biocon Ltd, Asia's premier biopharmaceuticals company, and Sandoz, a Novartis division and a global leader in  biosimilars, have announced a global partnership to develop, manufacture and commercialize multiple biosimilars in immunology and oncology for patients worldwide.  Under the terms of the agreement, both companies will share responsibility for end-to-end development, manufacturing and global regulatory approvals for a number of products and will have a cost and profit share arrangement globally. Worldwide commercialization responsibilities will be divided and each company’s strengths will be leveraged within specific geographies. Sandoz will lead commercialization in North America and the EU while Biocon will lead commercialization in Rest of the World. Biocon Chairperson & Managing Director Kiran Mazumdar-Shaw said: "We are pleased to announce our collaboration with Sandoz for developing a set of next generation biosimilar products.   This synergistic partnership will enable us to scale up our capabilities for an ‘end to end’ play in the global biosimilars space. We remain committed to pursue our mission of developing biopharmaceuticals that have the potential to benefit a billion patients across the globe.” Dr. Arun Chandavarkar, CEO & Joint MD, Biocon, added: “Biocon has worked at the leading edge of science and has demonstrated its capabilities in developing high quality biosimilars. Our credibility has been further endorsed by the recent USFDA approval of our Biosimilar Trastuzumab, which is also the first in the US.  Our collaboration with Sandoz will bolster our existing global biosimilars portfolio comprising biosimilar antibodies & insulin analogs and will enable us to address the next wave of global biosimilars opportunities.”   As an innovation-led biopharmaceutical company, Biocon has successfully developed and taken a range of novel biologics, biosimilar antibodies, rh-insulin and insulin analogs from 'lab to market'. The collaboration with Sandoz builds upon Biocon's successful progress in its existing global biosimilars program. The most recent USFDA approval of the first biosimilar of Trastuzumab, marks an important milestone for Biocon as it is also the first biosimilar to be approved in the US for any Company from India.  An early mover in the biosimilars space, Biocon has successfully launched its insulin glargine in Japan, Trastuzumab & Bevacizumab biosimilars in India and rh- Insulin, Insulin Glargine and biosimilar Trastuzumab in few emerging markets. Sandoz is committed to increasing patient access to high-quality biosimilars and has five biosimilars currently marketed worldwide, as well as a rich global pipeline. Sandoz is well placed to strengthen its position in the biosimilars space based on its experience and capabilities in development, manufacturing and commercialization. As a division of Novartis, the first global healthcare company to establish a leading position in both innovative and off-patent medicines, Sandoz benefits strongly from this unique blend of experience and expertise in many different market environments. Biocon’s collaboration with Sandoz addresses some of the biosimilar opportunities beyond the near term opportunities being addressed by Biocon’s existing successful global partnership with Mylan. This new partnership is a significant milestone in Biocon’s journey of developing advanced therapies that have the potential to benefit billions of patients. ]]> <![CDATA[Panacea Biotech and Serum team up for six-in-one vaccine]]> https://biospectrumindia.com/news/95/10218/panacea-biotech-and-serum-team-up-for-six-in-one-vaccine.html https://biospectrumindia.com/news/95/10218/panacea-biotech-and-serum-team-up-for-six-in-one-vaccine.html Thu, 18 Jan 2018 17:05:00 +0530 Panacea Biotec is research based pharmaceutical and health Management Company has signed two long-term agreements with Serum Institute of India and its wholly-owned subsidiary Bilthovan Biologicals BV, involving a fully liquid six-in-one vaccine.  Under the collaboration, Serum will be allowed to make and sell fully liquid Whole cell Pertussis (wP) and Salk-based Injectable Polio Vaccine (IPV) based Hexavalent vaccine (DTwP-HepB-Hib-IPV) developed and commercialised by Panacea Biotec. It is the first fully liquid wP-IPV-based hexavalent vaccine in the world. Serum Institute will ensure supply of IPV bulk to Panacea Biotec, an important constituent of the hexavalent vaccine, from its wholly-owned subsidiary Bilthovan Biologicals B V (BBIO). Bilthovan is a bioengineering and Pharmaceutical company registered in the Netherlands; BBIO has the technology to make the IPV, earlier possessed by only three other vaccine manufacturers in the world. In the next two years, both companies will work together to get this vaccine introduced in the National Immunisation Programme of the government and developing countries by working closely with key stakeholders. Panacea Biotec will work with stakeholders including government of different countries, World Health Organisation (WHO), Global Alliance for Vaccines & Immunisation (GAVI), Bill and Melinda Gates Foundation (BMGF) and other United Nations agencies. ]]> <![CDATA[Advertorial: Merck products touch lives in diverse ways]]> https://biospectrumindia.com/views/95/10216/advertorial-merck-products-touch-lives-in-diverse-ways.html https://biospectrumindia.com/views/95/10216/advertorial-merck-products-touch-lives-in-diverse-ways.html Thu, 18 Jan 2018 13:15:00 +0530 Before researchers can make scientific breakthroughs, they must have access to state-of-the-art tools, services and expertise in order to perform experiments and engineer new products. That’s where Merck foots in. Merck products touch lives in diverse ways and provide best-in-class lab materials, technologies and services. “Merck offer quality product solutions in all stages of analysis to help achieve fast, accurate results. Our workflow solutions for sample preparation, separation, detection and analysis. Speed and resolution are key in determining purity, identity or verifying composition. Merck is working towards solving the toughest problems of customers by collaborating with the global scientific community and through that, we aim to accelerate access to better health for people everywhere. The Sigma-Aldrich brand aroma raw materials consist of certified food grade, IFRA, natural, kosher and halal ingredients. All safe, all high-quality, all shipped fast to you. It might be floral or sweet. Fruity or waxy. Maybe you’re looking for documentation, or quick delivery options and pricing. Whatever you need for flavors and fragrances, we're here to serve you.  Flavor Ingredients As consumers are looking for new and interesting flavors, we strive to provide you with the newest ingredients for your next flavor formulation. From aroma chemicals to reaction flavors, we have the right products with a large organoleptic range.  Fragrance Ingredients When the right aromatic fragrance evokes an emotion, it can create great demand among consumers. That’s why we are dedicated to providing you with high-quality aroma chemicals that follow the guidelines designated by IFRA (International Fragrance Association) and meet the EU Regulation 1223/2009 so you can safely meet that demand with products you trust.” Explore your Senses with Merck ! Visit us at Flavours & Fragrance Expo on 16th & 17th February in Mumbai. Booth C 24, Bombay Exhibition Centre, Goregaon, Mumbai. ]]> <![CDATA[Piramal Enterprises exploring to restart formulation business in India ]]> https://biospectrumindia.com/news/95/10214/piramal-enterprises-exploring-to-restart-formulation-business-in-india-.html https://biospectrumindia.com/news/95/10214/piramal-enterprises-exploring-to-restart-formulation-business-in-india-.html Wed, 17 Jan 2018 15:50:00 +0530 Piramal Enterprises is assessing to come back in the domestic formulation market after a non-compete agreement with AbbottBSE 0.85 % expires this year. Piramal sold its domestic formulations business to Abbott for $3.8 billion in 2010 and then scaled up its remaining pharma businesses, focusing on over-the-counter products, global generics, contract manufacturing and critical care. The company is looking at introducing respiratory and central nervous system formulations in India. It has lined up meetings with distributors and trade channels to evaluate the market for such products and is expected to roll out the business by September.  Top executives of Piramal Enterprises were noncommittal about the specific therapies it would likely target.  Amid a slowdown due to regulatory action, India's Rs 1 lakh crore pharma spaces has emerged as a lucrative bet for companies that have seen their overseas markets, predominantly the US, getting eroded due to pricing and quality pressures. Piramal's OTC business is now among the top five in India and the company's goal is to enter the top three in the next three years. ]]> <![CDATA[Syndax Pharmaceuticals collaborates with Genentech ]]> https://biospectrumindia.com/news/95/10208/syndax-pharmaceuticals-collaborates-with-genentech-.html https://biospectrumindia.com/news/95/10208/syndax-pharmaceuticals-collaborates-with-genentech-.html Wed, 17 Jan 2018 10:55:00 +0530 Syndax Pharmaceuticals, Inc. is a clinical stage biopharmaceutical company developing entinostat and SNDX-6352 in multiple cancer indications. The company declared a new clinical partnership with Genentech, a member of the Roche Group. As part of the collaboration, the two companies will evaluate the combination of Syndax's entinostat, an oral, small molecule, class I HDAC inhibitor, and Genentech's programmed cell death ligand 1 (PD-L1) blocking antibody, atezolizumab (TECENTRIQ®).  The planned Phase Ib/II, open-label, multicenter, randomized trial will enroll patients with metastatic HR+, HER2- breast cancer who have experienced disease progression during or following first-line therapy. Genentech will be responsible for conducting the trial. The trial will be conducted as part of MORPHEUS, Roche's novel cancer immunotherapy development platform.  This is an adaptive platform that aims to develop combinations of cancer immunotherapies more rapidly and efficiently.  Syndax also has a separate collaboration with Genentech for ENCORE 602, a trial examining safety, tolerability and clinical activity of entinostat in combination with Tecentriq in triple-negative breast cancer. ENCORE 602 is expected to complete enrollment in the Phase II portion of the trial in the first half of 2018. ]]> <![CDATA[Forty Seven Inc. and Genentech work together for Leukemia and Bladder Cancer]]> https://biospectrumindia.com/news/95/10202/forty-seven-inc-and-genentech-work-together-for-leukemia-and-bladder-cancer.html https://biospectrumindia.com/news/95/10202/forty-seven-inc-and-genentech-work-together-for-leukemia-and-bladder-cancer.html Tue, 16 Jan 2018 13:25:00 +0530 Forty Seven Inc., a clinical-stage company focused on developing the next generation of transformational immuno-oncology treatments to enable patient's immune systems to defeat their cancer. The company has announced an agreement with Genentech Inc., a member of the Roche Group. The agreement for Genentech to sponsor two clinical trials combining Forty Seven's CD47 antibody, Hu5F9-G4, with Genentech's PD-L1 antibody, atezolizumab (TECENTRIQ), in patients with acute myeloid leukemia (AML) and with urothelial (bladder) cancer.  CD47 is an immune modulator molecule overexpressed on cancer cells that sends inhibitory signals to macrophages. Binding of Hu5F9-G4 to CD47 takes the brakes off macrophages enabling them to phagocytose, or swallow, tumor cells. ]]> <![CDATA[Jubilant got approval for pesticide project ]]> https://biospectrumindia.com/news/95/10198/jubilant-got-approval-for-pesticide-project-.html https://biospectrumindia.com/news/95/10198/jubilant-got-approval-for-pesticide-project-.html Mon, 15 Jan 2018 18:00:00 +0530 Jubilant Life Sciences has received a green nod for setting up a greenfield pesticide manufacturing unit at Bharuch, Gujarat at a cost of around Rs 250 crore, as per the official document.  The proposal is to set up a technical grade pesticide and pesticide-specific intermediate manufacturing facilities having a total production capacity of 32,350 tonnes per annum at a SEZ in Bharuch, Gujarat. In the letter issued to Jubilant Life Sciences, the Union environment ministry has said it has given the environment clearance to the company's greenfield project with some conditions after taking into account experts' views. Among conditions specified, the company has been asked to ensure that total pesticides production for domestic sales should include manufacturing of 10 per cent bio-pesticides and that to be achieved in five years from the date of commissioning of the project. The estimated cost is Rs 250 crore for setting up this Greenfield pesticide manufacturing unit in Bharuch.  The company has been asked to get 'consent to establish/operate' from the state pollution control board and conform to standards the effluent discharge to deep sea. According to the proposal, the proposed greenbelt pesticide manufacturing unit will be set up on 16,000 square meter of area in the the Bharuch Special Economic Zone (SEZ).  The company has total 20 hectares of area within the Bharuch SEZ, which is operated by Jubilant Infrastructure Ltd (JIL). ]]> <![CDATA[Lupin with Softovac enters the OTC segment ]]> https://biospectrumindia.com/news/95/10197/lupin-with-softovac-enters-the-otc-segment-.html https://biospectrumindia.com/news/95/10197/lupin-with-softovac-enters-the-otc-segment-.html Mon, 15 Jan 2018 17:25:00 +0530 Lupin Limited (Lupin) has made a foray into the over-the counter (OTC) segment under the ‘Lupin Life Consumer Healthcare’ umbrella with the pan-India launch of Softovac. Softovac is a 34 year old company has been trusted by millions of consumers who suffer from constipation and irregular bowel habits. Pegged at over USD 2.7 billion (INR 18862 crores) as on 2016 as per Nicholas Hall 2017 report , the Indian OTC market is expected to grow at a CAGR of 9 percent to cross the USD 6.5 billion (INR 44115 crores)mark by 2026. Softovac’s shift to OTC was piloted in West Bengal during which the brand witnessed a growth in sales of over 25 percent, and post the success of the pilot, a pan-India roll-out was initiated. As part of the launch, the brand has also launched a 360-degree communications campaign based on the insight of ‘incomplete evacuation creates a deep sense of dissatisfaction amongst consumers’. The brand has signed actor Anil Kapoor as a brand ambassador for Softovac who features in the TV campaign currently on air. This is also supplemented by print and digital campaigns, below-the-line and point-of sale activations, as well as outreach with key stakeholders in the healthcare industry. Softovac is available as a pack of 100 grams with two variants, regular and sugar-free. ]]> <![CDATA[USFDA accepts NDA of Ortho Dermatologics for acne treatment]]> https://biospectrumindia.com/news/95/10192/usfda-accepts-nda-of-ortho-dermatologics-for-acne-treatment.html https://biospectrumindia.com/news/95/10192/usfda-accepts-nda-of-ortho-dermatologics-for-acne-treatment.html Mon, 15 Jan 2018 12:30:00 +0530 Ortho Dermatologics, a Valeant Pharmaceuticals International, Inc. company, is one of the largest prescription dermatology businesses in the world dedicated to helping patients in the treatment of a range of therapeutic areas The company announced that the U.S. Food and Drug Administration (FDA) have accepted the New Drug Application (NDA) for IDP-121 (tretinoin 0.05%) lotion (ALTRENO™1) with a PDUFA action date of Aug. 27, 2018. If approved, ALTRENO will be the first tretinoin product in lotion form rather than a gel or cream. Acne, also known as acne vulgaris, is the most common skin disease in the United States, and as many as 50 million people in the United States may have the disease. As per the company, More than 4 million patients make appointments with dermatologists each year for acne. After approval, ALTRENO will be great resource for the treatment of all dermatological conditions. ]]> <![CDATA[Credihealth ties up with the Ministry of Electronics and Information Technology]]> https://biospectrumindia.com/news/95/10187/credihealth-ties-up-with-the-ministry-of-electronics-and-information-technology.html https://biospectrumindia.com/news/95/10187/credihealth-ties-up-with-the-ministry-of-electronics-and-information-technology.html Fri, 12 Jan 2018 15:30:00 +0530 To enable consumers to consult and book appointments with doctors and specialists from any of its 630 partner hospitals across the country, Credihealth has tied up with the Ministry of Electronics and Information Technology. With a strong commitment to simplifying access to healthcare through mobile technologies, Credihealth, India’s leading online medical assistance company, has tied up with the Ministry of Electronics and Information Technology to deliver its online services through 2.5 lakh Common Services Centres (CSC) across India. Under this partnership, Credihealth will now be able to deliver its services to consumers across 16,000 pin codes from urban, semi-urban, and rural areas of the country through these Common Services Centres. With 70% of these centres located in rural regions, patients across tier-3 and 4 locations, in addition to urban consumers, will be able to conveniently book appointments with doctors at any of its 630 partner hospitals. The Common Services Centres (CSC) scheme is one of the key projects under the Digital India programme, aimed to facilitate easy access points for delivery of essential public utility services, social welfare schemes, healthcare, financial, educational, and agricultural services, in addition to serving as points of access for B2C services for citizens in rural and remote areas of the country. Initially established to provide e-services at the gram panchayat level, the pan-India network caters to the various regional, geographic, linguistic, and cultural diversities of the Indian populace, thus furthering the government’s mandate of a socially, financially, and digitally inclusive society. Commenting on the announcement, Ravi Virmani, Founder and Managing Director, Credihealth said, “A majority of rural consumers in India face several problems when accessing medical services or seeking advanced treatment. Usually, the only option available to them is travelling several kilometres to the nearest city or town where there’s a hospital, despite which there’s seldom any guarantee that they will be able to find and book an appointment with the right doctor." "Through strategically located Common Services Centres, Credihealth will now help solve this problem for patients across rural and urban areas, by providing them with easily accessible and affordable ways of consulting doctors and specialists from some of the leading hospitals and healthcare providers in the country.” Credihealth will be offering exclusive discounted rates for consultations to low-income rural consumers. With each Common Service Centre (CSC) being equipped with computers, internet connectivity, and printers, Credihealth will soon also enable access to its remote diagnostics and telemedicine services for patients in the near future. ]]> <![CDATA[Lymphoseek is launched Finland and Sweden]]> https://biospectrumindia.com/news/95/10188/lymphoseek-is-launched-finland-and-sweden.html https://biospectrumindia.com/news/95/10188/lymphoseek-is-launched-finland-and-sweden.html Fri, 12 Jan 2018 15:15:00 +0530 Norgine B.V. announced the launch of LYMPHOSEEK® (Tc 99m tilmanocept) in Finland and Sweden. LYMPHOSEEK® is a radiopharmaceutical used for diagnostic purposes by nuclear medicine specialists and surgeons. It is specifically designed for a procedure called sentinel lymph node biopsy (SLNB) and represents a significant alternative to the current method of identifying sentinel lymph nodes in adult patients with breast cancer, melanoma, or localised squamous cell carcinoma of the oral cavity. LYMPHOSEEK® has been specifically designed to target, and be retained in sentinel lymph nodes, the first lymph node (or group of nodes) to which cancer cells are most likely to spread from a primary tumour. It detected sentinel lymph nodes in 99% of patients with Tis, Tx or T1-T4cN0 breast cancer and in 97% of patients with T1-T4cN0 melanoma.  LYMPHOSEEK® offers particular value in identifying lymphatic drainage from tumours in the floor of the mouth (underneath the tongue) which can prove especially difficult. Currently up to 70-80% of patients with early oral cancer receive elective neck dissection surgery, a major procedure which could be avoided by using sentinel lymph node biopsy (SLNB) for staging. ]]> <![CDATA[HITLAB and Unitus Seed Fund Invite Healthcare Innovators to the 2018 HITLAB World Cup: India]]> https://biospectrumindia.com/news/95/10185/hitlab-and-unitus-seed-fund-invite-healthcare-innovators-to-the-2018-hitlab-world-cup-india.html https://biospectrumindia.com/news/95/10185/hitlab-and-unitus-seed-fund-invite-healthcare-innovators-to-the-2018-hitlab-world-cup-india.html Fri, 12 Jan 2018 11:30:00 +0530 NEW DELHI: HITLAB, in association with StartHealth, an initiative of Unitus Seed Fund and part of India's leading impact venture fund investing in early-stage startups innovating for the masses, announced the 2018 HITLAB World Cup: India. Innovators worldwide are invited to submit their original technology-enabled healthcare solutions and finalists, selected by a panel of healthcare experts, will have the opportunity to make pitches for up to USD $500,000 (INR 3.5 crore) in grants and equity funding. The pitch event will take place during the HITLAB Innovators Summit: India, held on February 10, 2018 at the India Institute of Technology in Delhi. The HITLAB Innovators Summit offers a series of curated talks, panels, and collaboration opportunities to engage the most creative minds in health and technology. The theme for this year's Summit—the fourth to be held in India—is Enabling Inclusive Digital Health Innovation and Diffusion. "HITLAB World Cup: India empowers innovators to translate ingenious ideas into practicable solutions that have immense potential to improve healthcare design, delivery, and access in Indiaand across the globe. We're very excited to have Unitus Seed Fund partner with us to expand the impact of groundbreaking innovations," said Devmalya Sarkar, Summit Director, HITLAB. "India ranks sixth among the 50 low-middle income nations in regards to out-of-pocket healthcare spend. Startups are addressing this by building novel solutions to make healthcare more accessible and affordable to millions of Indians for whom it is otherwise out of reach. At Unitus Seed Fund, healthcare continues to be an exciting sector, and we plan to invest in innovative and scalable health-tech businesses over the next three years. We've set aside INR 100 crore for this, and are very excited to partner with HITLAB to find and nurture new-age startups in India's healthcare sector," said Milind Shah, Venture Partner, Unitus Seed Fund. The deadline for innovators to submit their concepts is January 14, 2018 ]]> <![CDATA[ISCR conference 2018: Collaborative clinical research for better patient outcomes]]> https://biospectrumindia.com/news/95/10176/iscr-conference-2018-collaborative-clinical-research-for-better-patient-outcomes.html https://biospectrumindia.com/news/95/10176/iscr-conference-2018-collaborative-clinical-research-for-better-patient-outcomes.html Wed, 10 Jan 2018 15:05:00 +0530 Collaborative Clinical Research for Better Patient Outcomes will be the theme of the 11th Annual Conference of the Indian Society for Clinical Research (ISCR) which will be held at JW Marriott, Bangalore, from January 19th to 20th. The two-day event is focused on bringing together different stakeholders across the clinical research continuum on a common platform to deliberate on the future that the clinical research fraternity in India needs to take in an improved regulatory environment.   Stakeholders will meet and deliberate on opportunities to learn, partner and collaborate while strengthening the ethical conduct of clinical research and creating better outcomes for patients. Around 400-500 clinical research professionals are expected to attend the event. Leading up to the annual conference, five pre-conference workshops have been scheduled for the clinical researcher fraternity and medical and pharma students on January 17th and 18th. These workshops will focus on principles of evidence based medicine and its applicability in India, career opportunities in clinical research and associated fields, pharmacovigilance (PV) audits and inspections, role of clinical pharmacology in drug discovery and development and risk based monitoring in clinical trials. ]]> <![CDATA[Triesta Unit of HCG to Combine with Strand Life Sciences]]> https://biospectrumindia.com/news/95/10175/triesta-unit-of-hcg-to-combine-with-strand-life-sciences.html https://biospectrumindia.com/news/95/10175/triesta-unit-of-hcg-to-combine-with-strand-life-sciences.html Wed, 10 Jan 2018 14:45:00 +0530 Healthcare Global Enterprises, Ltd. has announced execution of definitive agreements for the business combination of its Triesta Sciences business unit (“Triesta”) with Strand Life Sciences Pvt. Ltd. (“Strand”). Strand, established in 2000 as a spin-off from the Indian Institute of Science, is a bioinformatics company working with global technology vendors and research laboratories, and is the leader in genomic testing for cancer and inherited diseases in India. Triesta is a unit of HCG and offers comprehensive molecular diagnostics services and research services in the field of oncology. The combination of Triesta and Strand creates an integrated platform with end to end capabilities in precision medicine - proprietary analytics, clinical research, access to the HCG biorepository, genomic technologies, assay development and validation and a network of laboratories offering a broad menu of tests. Dr. B.S. Ajaikumar, Chairman and CEO of HCG, said “Strand and Triesta have been working together in bioinformatics and clinical genomics. We are now excited to combine our strengths and resources towards redefining precision medicine. In an era of data driven healthcare, Strand’s exceptional team of computer and life scientists with access to a well annotated clinical substrate, provides a unique opportunity to create exceptional value.” Dr. Ramesh Hariharan, Founder and CEO of Strand, said “Triesta and HCG have been pioneers in bringing the latest advancements in molecular biomarkers into clinical practice in the country. Together we are well on the path to building Asia’s leading integrated analytics driven diagnostic and genomics research company. Through this alliance we will work together to be at the forefront of precision medicine”.       ]]> <![CDATA[Agilent acquired Luxcel Biosciences]]> https://biospectrumindia.com/news/95/10172/agilent-acquired-luxcel-biosciences.html https://biospectrumindia.com/news/95/10172/agilent-acquired-luxcel-biosciences.html Wed, 10 Jan 2018 11:50:00 +0530 Agilent Technologies Inc. announced that it has acquired Cork, Ireland-based Luxcel Biosciences (“Luxcel”), a developer of real time fluorescence plate-reader based in vitro cell assay kits. This acquisition expands Agilent’s cell analysis portfolio with the addition of easy-to-use assay kits that are compatible with industry standard plate-readers. Luxcel is developing a portfolio of in vitro cell-based assay kits and solutions targeting cell metabolism, drug safety and toxicity, as well as hypoxia and oxidative stress for a variety of life science customers from research institutions to pharmaceutical companies. Scientists use this technology to understand the roll of cell metabolism across a variety of important research areas including cancer, metabolic disorders, cardiovascular disease, immunology, and infectious disease.  Agilent entered the cell analysis market in 2015 with the acquisition of Seahorse Bioscience, a leader in providing specialized instruments and live-cell, kinetic assays.  The Luxcel team will remain in Cork and form a dedicated sensor chemistries and bioassay solutions group within Agilent’s Cell Analysis Division. Financial terms of the deal are not being disclosed. ]]> <![CDATA[Abbott, YRGCARE team up to track HIV, Hepatitis patterns ]]> https://biospectrumindia.com/news/95/10171/abbott-yrgcare-team-up-to-track-hiv-hepatitis-patterns-.html https://biospectrumindia.com/news/95/10171/abbott-yrgcare-team-up-to-track-hiv-hepatitis-patterns-.html Wed, 10 Jan 2018 11:20:00 +0530 Strengthening India’s efforts in combating HIV and hepatitis viruses, Abbott has announced its partnership with Y.R. Gaitonde Centre for AIDS Research and Education (YRGCARE) to study the country’s viral diversity to improve accuracy of diagnostic tests. Abbott will provide study protocol and diagnostic equipment and YRGCARE will help in screening and sequencing rich patient data from infected populations in India.  HIV and viral hepatitis are among the biggest public health threats in India today as they can produce many genotypes, which keep combining to form recombinant strains or mutations making detection trickier. Therefore, understanding the distribution of genotypes and recombinants is critical to the development of diagnostic tests.  With more than 2.1 million people living with HIV, India has the third largest HIV incidence in the world with a large part co-infected with hepatitis C virus (HCV). People who inject drugs (PWID) and sex workers are identified as key affected populations for which the epidemic is growing. Established more than twenty years ago, Abbott’s Global Surveillance Programme spans 40 countries across six continents, identifying and characterizing more than 5,000 virus strains, ensuring that current diagnostic tests to detect a wide range of HIV and hepatitis viruses and determine the need for newer tests to stay ahead of evolving viruses.  India is the latest addition to Abbott’s recent surveillance efforts in Asia-Pacific to provide new insights on the strains and transmission of these viruses specific to India. Abbott is the only diagnostic test manufacturer with such a unique, longstanding and large-scale virus Surveillance Programme. Besides India, Abbott has collaborated with partners in China, Australia, Vietnam, Laos and Pakistan to ensure its Surveillance Programme covers key regions.  In addition, Abbott works with commercial partners in Nepal the Philippines as well as the Red Cross in Thailand to gain access to circulating strains of HIV and hepatitis viruses, thus ensuring a real representation of the prevalent infections. ]]> <![CDATA[Ratan Tata invests in a marijuana research startup based in Mumbai]]> https://biospectrumindia.com/news/95/10131/ratan-tata-invests-in-a-marijuana-research-startup-based-in-mumbai.html https://biospectrumindia.com/news/95/10131/ratan-tata-invests-in-a-marijuana-research-startup-based-in-mumbai.html Tue, 09 Jan 2018 17:25:00 +0530 Ratan Tata, the chairman emeritus of Tata Sons, and Google India's managing director Rajan Anandan are among a group of investors supporting the Bombay Hemp Company (Boheco), the first startup in the country to study the medical use of cannabis in partnership with the Council of Scientific and Industrial Research (CSIR). The Mumbai-based company has raised a seed capital of around Rs 6.5 crores from the marquee investors. Boheco will grow cannabis and study its medicinal properties for use in the treatment of epilepsy and breast cancer, as well as for palliative care. According to a media report, “In 2016, cannabis-related startups raised $66.3 million in venture capital funding, mostly in the United States. Globally, the cannabis market is expected to hit $31.4 billion by 2021, with the US currently driving 90% of the sales, according to a recent report from cannabis market research firm, the Brightfield Group. In recent years, China has also increased its focus on hemp cultivation, with the China Hemp Research Centre being set up in Beijing.” "Jahan Peston Jamas, co-founder of Boheco said the company reached another milestone this year with the creation of nanocarbon, a form of renewable energy from the hemp fibre, making it one of the only Asian startups to be invited to join the Singularity University Accelerator in California", says the report. ]]> <![CDATA[INC Research/inVentiv Health is now Syneos Health]]> https://biospectrumindia.com/news/95/10169/inc-research-inventiv-health-is-now-syneos-health.html https://biospectrumindia.com/news/95/10169/inc-research-inventiv-health-is-now-syneos-health.html Tue, 09 Jan 2018 14:35:00 +0530 INC Research/inVentiv Health has announced that it has changed its brand identity to Syneos Health, Inc., effective January 4, 2018. More than 21,000 of the top minds in clinical and commercial development are now united under this singular brand, signifying the culmination of a thoughtful merger combining industry-leading Contract Research Organization (CRO) and Contract Commercial Organization (CCO) capabilities. Purpose-built for modern biopharmaceutical market realities, Syneos Health is the only fully integrated, end-to-end biopharmaceutical solutions organization.   Alistair Macdonald, Chief Executive Officer of Syneos Health said, “Syneos Health fully expresses our value proposition – that is, our ability to deliver integrated end-to-end solutions and create new paths for our customers to develop and commercialize their therapies.Unlike traditional CROs and commercialization businesses, we are knocking down walls and enabling clinical and commercial experts to work in sync by using the latest technologies, advanced business practices and the advantages of scale. Our Biopharmaceutical Acceleration Model is unique to the industry, and from this ambitious vision, Syneos Health was born.” Macdonald continued, “As commercialization experts, we understand the importance a strong brand plays in creating differentiation, conversion and loyalty. Our new identity reinforces our fully integrated business model, positions Syneos Health as a high-value solutions partner, and is designed to attract and retain top talent committed to shortening the distance from lab to lifeTM.” In connection with the name change, Syneos Health common shares are expected to trade on the Nasdaq Global Select Market under the new ticker symbol “SYNH” by January 9, 2018.Until then, Syneos Health will continue to be listed under INC Research Holdings, Inc. and the symbol “INCR.” ]]> <![CDATA[Palatin Technologies received FDA nod of Investigational New Drug Application for PL-8177]]> https://biospectrumindia.com/news/95/10164/palatin-technologies-received-fda-nod-of-investigational-new-drug-application-for-pl-8177.html https://biospectrumindia.com/news/95/10164/palatin-technologies-received-fda-nod-of-investigational-new-drug-application-for-pl-8177.html Mon, 08 Jan 2018 15:45:00 +0530 Palatin Technologies is a biopharmaceutical company developing targeted, receptor-specific peptide therapeutics for the treatment of diseases with significant unmet medical need and commercial potential. The company  announced that the U.S. Food and Drug Administration (FDA) has notified Palatin that it may proceed with its clinical investigation of subcutaneous injection PL-8177 as a potential treatment for patients with ulcerative colitis. The notice to proceed was received following Palatin's submission of an investigational new drug (IND) application for this program. Palatin expects to commence a Phase 1 single and multiple ascending dose study in the current quarter.  PL-8177, a selective melanocortin receptor 1 (MC1r) agonist peptide, is Palatin's lead clinical development candidate for ulcerative colitis and other inflammatory bowel diseases.  Agents that modulate the MC1r system may have therapeutic potential in a variety of inflammatory disease indications.  PL-8177 is a cyclic peptide that has demonstrated efficacy in animal inflammatory bowel disease models.  Palatin has developed an oral formulation of PL-8177 that has been validated in animal studies, and is scheduled to be explored in future clinical investigations.  PL-8177 is highly specific for MC1r, with sub-nanomolar affinity binding and EC50 functional values.   ]]> <![CDATA[Merck Foundation partners with India to enhance healthcare]]> https://biospectrumindia.com/news/95/10161/merck-foundation-partners-with-india-to-enhance-healthcare.html https://biospectrumindia.com/news/95/10161/merck-foundation-partners-with-india-to-enhance-healthcare.html Sun, 07 Jan 2018 17:35:00 +0530 Merck Foundation has partnered with India to provide training for future African oncologists and fertility specialists to improve access to quality and equitable cancer and fertility care in Africa. In partnership with Asian Academia and Maharashtra University, Merck Foundation conducted their advisory board to define the strategy to scale up the Merck Foundation programs across Asia, through providing training and fellowship programs in India and Europe. In 2017, through their Merck cancer access program, Merck Foundation partnered with Tata Memorial center and Maharashtra University to provide one and two years oncology fellowship program for more than 30 Doctors from African countries. Merck Foundation has also partnered with IIRRS (International Institute for Training and Research in Reproductive Health), to provide three months clinical and practical training for future African fertility and embryologists, as many African countries do not have fertility specialists or Embryologists. Merck Foundation has expanded their Cancer access program and 'Merck more than a Mother' campaign to more Asian countries such as; Nepal, Bangladesh, Cambodia, Myanmar, Sire Lanka, Indonesia, Malaysia in addition to India. Merck KGaA Germany launched their Merck Foundation, a non-profit company established in June 2017 at the Fourth edition of their annual "Merck Africa Asia Luminary" held in Cairo, Egypt. ]]> <![CDATA[ANTABIO declares key designations]]> https://biospectrumindia.com/news/95/10158/antabio-declares-key-designations.html https://biospectrumindia.com/news/95/10158/antabio-declares-key-designations.html Fri, 05 Jan 2018 18:20:00 +0530 Antabio SAS, a biopharmaceutical company developing novel antibacterial treatments in areas of highest unmet needs. The company has announced the addition of four highly successful and accomplished biotech executives to the management team. These appointments came after the first closing of Antabio’s Series A financing round and notification that Antabio has been selected as one of 18 out of 368 international candidates for a CARB-X subsidy award of up to $8,9 million.  Starting January 1st 2018 and on a part-time basis, Gordon Waldron will lead Finance, Carole Sable will oversee Clinical Strategy, Helmuth van Es will direct Business Development and David Lathbury will manage CMC activities.  These executives have built strong track records directing and growing innovative biotech companies, forging alliances, maximizing shareholder value and taking products through pre-clinical and clinical development to market. Gordon Waldron and Carole Sable have previously worked together at Novexel (as CFO and CMO, respectively) where they held leadership roles in the financing and development of a novel anti-infective pipeline prior to concluding the successful sale of Novexel in 2010.  Helmuth van Es was a founder of Galapagos which has become one of the leading biotech companies in Europe with a market capitalization of €4 billion. David Lathbury was previously Director of Process Chemistry at AstraZeneca and VP of Chemical Development at AMRI.  Antabio’s lead molecule is now in preclinical development and is expected to enter the clinic in early 2019 with fast track to potential market approval by 2023. This programme aims to develop a metallo beta-lactamase inhibitor (“MBLI”) combined with meropenem. The incidence of metallo beta-lactamase resistance is rising sharply in many areas of the world and in particular in China. Antabio’s second programme targets chronic Pseudomonas infections. This programme has recently earned support from the global CARB-X initiative with up to $8.9M non-dilutive funding and free access to NIH preclinical services up to completion of Phase 1.  The company is in the process of seeking further pipeline expansion through external opportunities and additional funds to accelerate development. ]]> <![CDATA[Infosys collaborates with ValGenesis for digitising healthcare sector]]> https://biospectrumindia.com/news/95/10151/infosys-collaborates-with-valgenesis-for-digitising-healthcare-sector.html https://biospectrumindia.com/news/95/10151/infosys-collaborates-with-valgenesis-for-digitising-healthcare-sector.html Fri, 05 Jan 2018 11:00:00 +0530 Infosys has teamed up with the California-headquartered paperless validation company ValGenesis to help biopharma and medical devices customers transform to next generation of automation driven quality and compliance services which will help organisations generate significant efficiencies and allow them to focus on their core business. Under the partnership, Infosys will integrate ValGenesis' "Validation Lifecycle Management System" (VLMS) within its suite of services for the pharmaceutical and biotech industry which will be delivered in secure Cloud environment. The ValGenesis Validation Lifecycle Management System (VLMS) manages all types of validation activities such as equipment, computer systems, cleaning, analytical methods, and process validation. The system delivers technology solutions that are fully configurable and rapidly deployable onsite or by way of a secured Cloud environment. Healthcare is potentially the world's most stringently-regulated industry. The huge volumes of highly-sensitive information that biotech and life sciences firms generate is subject to incredibly strict standards - for example, recording the outcomes from clinical trials. Infosys intends to enhance compliance and quality management for its customers in the healthcare and life sciences sectors.      ]]> <![CDATA[Glenmark launches biosimilar Adalimumab in India ]]> https://biospectrumindia.com/news/95/10148/glenmark-launches-biosimilar-adalimumab-in-india-.html https://biospectrumindia.com/news/95/10148/glenmark-launches-biosimilar-adalimumab-in-india-.html Thu, 04 Jan 2018 14:25:00 +0530 Mumbai based Glenmark Pharmaceuticals said it has launched the biosimilar Adalimumab under a licensing agreement with Cadila Healthcare Ltd. Adalimumab is used in the treatment of Plaque Psoriasis and Rheumatoid Arthritis is the spin off version of US drug maker AbbVie which sells the drug in the name of Humira. Adalimumab biosimilar in India was first launched by Zydus in 2014. Glenmark will market the biosimilar drug under the name of ADALY. Glenmark did not give any financial detail for the drug, but globally Adalimumab is estimated to be a $16 billion drug in 2016, making it the "best" selling drug in the world. For Glenmark this is the first biosimilar launch in India. "The launch of this biosimilar will significantly enhance our presence in this segment. We are encouraged by the recent launch of Apremilast for psoriasis in India and the launch of ADALY reaffirms our commitment towards meeting unmet needs of patients and providing the latest treatment options," said Sujesh Vasudevan, President - India Formulations, Middle East and Africa at Glenmark. ]]> <![CDATA[Hetero introduces HumiraTM to treat rheumatoid arthritis in India]]> https://biospectrumindia.com/news/95/10140/hetero-introduces-humiratm-to-treat-rheumatoid-arthritis-in-india.html https://biospectrumindia.com/news/95/10140/hetero-introduces-humiratm-to-treat-rheumatoid-arthritis-in-india.html Wed, 03 Jan 2018 18:00:00 +0530 Hetero is one of India’s leading generic pharmaceutical companies and the world’s largest producer of anti-retroviral drugs for the treatment of HIV/AIDS. The company has launched its fourth biosimilar drug ‘Adalimumab’ under the brand name ‘MaburaTM’ in India. Adalimumab is the first fully human monoclonal antibody which was first approved by US FDA in 2002. Indian drug maker Hetero has launched a biosimilar of AbbVie’s 'HumiraTM' (adalimumab) for the treatment of rheumatoid arthritis and other auto immune disorders in India.  MaburaTM is an anti-inflammatory biologic medication specific for human tumor necrosis factor (TNF) and the auto-immune disorders it is indicated for include psoriatic arthritis, ankylosing spondylitis, Crohn’s disease and ulcerative colitis. According to company, the product will be marketed by Hetero Healthcare under the brand name ‘MaburaTM’ in India. MaburaTM will be available as a pre-filled syringe (PFS) of 40mg and is administered subcutaneously. Hetero did not disclose the price at which it would be marketing the drug in the country. ]]> <![CDATA[Coromandel acquires EID Parry ]]> https://biospectrumindia.com/news/95/10139/coromandel-acquires-eid-parry-.html https://biospectrumindia.com/news/95/10139/coromandel-acquires-eid-parry-.html Wed, 03 Jan 2018 15:30:00 +0530 Secunderabad based, Coromandel International Ltd (CIL) is an India's second largest phosphatic fertiliser and crop protection player which is a part of the diversified Rs 300 billion conglomerate Murugappa Group. The company has announced the acquisition of Bio-Pesticides business from E.I.D. Parry together with its wholly owned subsidiary Parry America, Inc, USA. The transaction is valued at Rs 338 crore. EID Parry, which is in the business of sugar, nutraceuticals and bio pesticides. The bio-pesticides business is engaged in the manufacture and marketing of neem based Azadirachtin technicals and formulations, plant extract based bio-stimulants, etc. It has a manufacturing facility in Tamil Nadu and a research and development centre. In R & D unit it has made significant progress on bio-stimulants, microbials and household pesticide segment for domestic and global markets. Coromandel International feels that the complementary market presence in both Indian and global markets by both the companies provides an opportunity for both chemical and bio-pesticides to grow. Post-acquisition, Coromandel will further strengthen its position in the crop protection segment. While the bio pesticide business of EID Parry clocked a turnover of Rs 121.74 crore in 2016-17, Parry America Inc logged a turnover of $8.525 million in 2016-17. The acquisition is expected to be completed by April 2018. ]]> <![CDATA[WHO prequalifies Bharat Biotech’s typhoid conjugate vaccine]]> https://biospectrumindia.com/news/95/10138/who-prequalifies-bharat-biotechs-typhoid-conjugate-vaccine.html https://biospectrumindia.com/news/95/10138/who-prequalifies-bharat-biotechs-typhoid-conjugate-vaccine.html Wed, 03 Jan 2018 14:45:00 +0530 Bharat Biotech’s Typbar TCV, the world’s first clinically proven Typhoid Conjugate Vaccine against typhoid fever has received prequalification from World Health Organisation (WHO). This enables the procurement and supplies of this life saving vaccine to UNICEF, Pan-American Health Organization (PAHO) and GAVI supported countries. Typbar TCV has been evaluated in Human Challenge Studies at Oxford University and typhoid conjugate vaccines have been recommended by WHO’s Strategic Advisory Group of Experts on Immunization (WHO-SAGE).    Typbar TCV is the first typhoid vaccine, clinically proven to be administered to children from 6 months of age to adults and confers long term protection against typhoid fever.  International Health Metrics and Evaluation (IHME) estimates that in 2016, there were approximately 12 million cases of typhoid fever resulting in around 130,000 deaths. Typhoid fever is caused by the bacterium Salmonella Typhi (S. Typhi), which infects humans due to contaminated food and beverages from sewage and other infected humans. Currently a third of the global population is at risk of typhoid fever, which results in reduced school attendance, loss of work and wages, lowered pregnancy outcomes and impaired physical and cognitive development of children. In most developing countries the cost of a course of treatment for typhoid fever ranges from $50 to $5000 for outpatient and inpatient treatments.           Typbar TCV is a result of dedicated product development at Bharat Biotech since 2001, where all aspects of the product profile were studied and evaluated in human clinical trials. With 5 years of follow up data for seroconversion, Typbar TCV at 25µg / dose has proven long term protection for children and adults alike, and can be administered to children from 6 months of age. Bharat Biotech is thankful to Dr. John Robbins, who in 1999 trusted the team to deliver the promise of vaccines against typhoid fever.   Enlightening the importance of WHO prequalification for an effective typhoid vaccine that is also safe for infants Dr. Krishna Ella, Chairman and Managing Director of Bharat Biotech said “Typbar TCV is the first typhoid conjugate vaccine, clinically proven to be administered to children from 6 months of age to adults and confers long term protection against typhoid fever. When we started this project, Typhoid fever was a neglected tropical disease. This success is a true reflection of Team Bharat Biotech’s, ability to develop novel vaccines and sustain long term product development for fighting infectious diseases. It demonstrates the power of global partnerships to achieve novel breakthroughs.” WHO-SAGE recommended the use of typhoid conjugate vaccines for use in infants between 6 and 23 months of age and catch up vaccinations for children between 2 and 15 years of age. This recommendation paves the way for countries to introduce the vaccine into their immunization programs. “With the recent Gavi Board approval of an US$ 85 million funding window to make the typhoid conjugate vaccine available in Gavi-supported countries, we now expect the first introductions to take place as soon as the first half of 2019,” said Dr Seth Berkley, CEO of Gavi, the Vaccine Alliance. “One of the main barriers to controlling typhoid has been the availability of a vaccine that is effective in young children, so this vaccine will be a game-changer for millions of the most vulnerable. This vaccine will not only save lives but considering the growing spread of drug resistant strains of typhoid, it will also prove to be a valuable weapon against antimicrobial resistance.” Revealing the go-to-community strategy for its affordable global typhoid fever vaccine in the global markets Dr. Ella said; “For Typbar TCV to reach vulnerable populations, we are pleased to announce the price of $ 1.50/ dose for procurement for GAVI supported countries. Also, recognizing the importance of sustained vaccine procurement for low income and low-middle income countries, and in the interest of global public health, we announce a further price reduction to around $ 1.0 or below  / dose, post procurement of 100 million doses for LIC’s and LMIC’s.”   The threat of antimicrobial resistance due to the overuse of antibiotics has resulted in multi drug resistant typhoid, similar to the reports from several parts of the world, and especially from Hyderabad Pakistan, where ceftriaxone-resistant typhoid was detected during 2016. Bharat Biotech has partnered with Aga Khan University Hospital in Hyderabad, Pakistan to introduce Typbar TCV to vulnerable populations in Pakistan. Towards this endeavor Bharat Biotech had generously donated 50,000 doses and agreed to supply an additional 200,000 doses at highly subsidized rates.     “India’s leadership in developing this new typhoid vaccine reinforces a national commitment to improving the health of children around the world. For too long, typhoid, which invariably affects the world’s poorest people, has been neglected in efforts to improve global health,” said Dr. Anita Zaidi, the director of the Vaccine Development, Surveillance, and Enteric and Diarrheal Diseases teams at the Bill & Melinda Gates Foundation, which supported efforts that helped generate data for prequalification. “With this new vaccine – the first-ever to be useful for preventing typhoid in young children – countries will finally be able to protect millions of children who are most vulnerable to this deadly disease.” Oxford University conducted a human challenge study with Typbar TCV at 25µg / dose, where the subjects were challenged with live S. Typhi proving a protective efficacy of 87% against typhoid fever.       “The WHO prequalification of Typbar TCV marks an important milestone in the global effort to rid the world of typhoid fever and improve health for some of the most vulnerable populations in the world.” said Prof Andrew Pollard, University of Oxford. With the aim to accelerate the introduction of new typhoid conjugate vaccines as part of an integrated approach to reduce the burden of typhoid disease, Bharat Biotech has partnered with the Typhoid Vaccine Acceleration Consortium (TyVAC), a union between the Center for Vaccine Development at the University of Maryland, the Oxford Vaccine Group at Oxford University, and PATH. The consortium is conducting effectiveness studies for typhoid conjugate vaccines in Nepal, Malawi, and Bangladesh. Bharat Biotech has donated 50,000 doses of Typbar TCV, towards the conduct of these studies.   “The prequalification of the first typhoid conjugate vaccine is a major advancement for child health,” said Dr. Kathy Neuzil, director of the Center for Vaccine Development at the University Of Maryland School Of Medicine. “Typbar TCV can be incorporated into routine vaccination schedules, giving us the best chance to reach children most at risk for this devastating disease.” In its efforts to become a comprehensive health care solutions provider for vaccine preventable infectious diseases, Bharat Biotech has partnered with the University of Maryland and the Wellcome Trust to develop and evaluate vaccines for non typhoidal salmonella (NTS) against the serovars Typhimurium and Enteritidis. The burden of disease from NTS is highest in sub Saharan Africa and a successful vaccine will result in a major impact on the disease burden from salmonellosis in Africa. Further, to develop a Salmonella Paratyphi A vaccine with the aim of providing future combination vaccines towards complete protection against salmonellosis, Bharat Biotech has an ongoing partnership with the University of Maryland. Bharat Biotech has also partnered with the Navi Mumbai Municipal Corporation and the Centers for Disease Control USA, to evaluate the effectiveness of Typbar TCV in Navi Mumbai. Dr. Krishna Ella, has generously donated 100,000 doses and agreed to supply an additional 300,000 doses at highly subsidized rates towards the conduct of these effectiveness studies.        Dr. M. K. Bhan, Former Secretary, Department of Biotechnology, Govt of India, said “Typbar TCV is a weapon against the high but under appreciated burden of Typhoid fever in children and adults. Immunisation will reduce use of antibiotics in acute febrile illnesses and antibiotic resistance.” To provide global access to Typhoid Conjugate Vaccines, to save lives of populations in low income countries, Bharat Biotech is collaborating with the Clinton Health Access Initiative (CHAI). Bharat Biotech is able to supply up to 50 million doses / year and is actively working on expanding its manufacturing capacity to reach ~ 200 million doses. This will truly fulfill its mission to develop novel vaccines, manufacture and supply high volumes of high quality vaccines at affordable prices for low income countries and low-middle income countries. Mr. Ira C. Magaziner, Chief Executive Officer at CHAI stated, “This significant price reduction for the typhoid conjugate vaccine will help save thousands of lives, particularly of the most vulnerable children. With its promise of an even lower price in the future, Bharat Biotech is making an important contribution to enable sustainable access to this vaccine in low-income countries. Registrations for Typbar TCV are in process in more than 30 countries globally. With the vaccine already registered in India, Nigeria, Cambodia, Nepal, etc signaling assured global access to this life saving vaccine and delivering it to the populations that need it the most.       ]]> <![CDATA[Cargill to broaden India portfolio, invest Rs 15 bn in coming years]]> https://biospectrumindia.com/news/95/10134/cargill-to-broaden-india-portfolio-invest-rs-15-bn-in-coming-years.html https://biospectrumindia.com/news/95/10134/cargill-to-broaden-india-portfolio-invest-rs-15-bn-in-coming-years.html Wed, 03 Jan 2018 12:15:00 +0530 Cargill India is expanding its presence in the country and has prepared a plan to broaden its portfolio, which includes aqua feed and aqua premix, animal feed, plant for transfer fuels, strengthening edible oil brand, corn wet milling, and cocoa products for catering to the needs of chocolate making companies. Around Rs 15 billion in investments has been committed by its parent for the Indian market over the next few years. Cargill is already supplying cocoa products like cocoa powder, cocoa butter and cocoa liquor to global chocolate giants. Cargill is also exploring investment in the cocoa and chocolate space in India. Now, the company plans to prepare these product mixes in India and supply them to domestic Chocolate companies. As of now, cocoa products are largely imported because they are duty-free while making them in India requires importing cocoa beans, which attract 30 per cent import duty. Cargill India Chairman Siraj Chaudhry said, "The government should consider the proposal to change this inverse duty structure to promote 'Make in India'." Cargill has a few brands – Nature Fresh, Gemini, Sweekar, Leonardo, and Rath Vanaspati – in India, and the company is prominent in edible oils and aata (flour). It is already supplying to meet the edible oil requirements of global quick service restaurant (QSR) companies in India and major food companies. It is also supplying glucose and maltodextrin to leading food and healthcare companies. Cargill India's other plans include expanding or acquiring new units in the area of aqua premix and animal feed-nutrition. "We have also set up a plan and started last fortnight for manufacturing natural transformer fuel from edible oil, which is much more environmentally friendly and useful in green cities that are coming up," said Chaudhry. This is a first in India as, so far, this fuel is made from mineral oil. Cargill has set up a storage facility for grains and oilseeds in Karnataka and a part of its future investments will go towards expanding the company's storage capacity. Already, an investment of Rs 1 billion is underway for storage. Cargill India has also acquired an animal feed plant in Andhra Pradesh that the firm will spend money on to improve technology and for its expansion. Animal premix required for making animal feed will also be a focus area and, whenever an opportunity arises, "we may also go for an acquisition", Chaudhry said.   ]]> <![CDATA[Patent for Flu Vaccine granted in India]]> https://biospectrumindia.com/news/95/10133/patent-for-flu-vaccine-granted-in-india.html https://biospectrumindia.com/news/95/10133/patent-for-flu-vaccine-granted-in-india.html Wed, 03 Jan 2018 11:55:00 +0530 BiondVax is an advanced clinical stage biopharmaceutical company developing a universal flu vaccine. The company announced that one of its key patents titled "A Synthetic or Recombinant Influenza Multi-Epitope Polypeptide" has been granted in India. The patent belongs to BiondVax's portfolio family titled "Multimeric Multi-Epitope Influenza Vaccines" and has now been granted in over 30 countries.  India, with high population is an important potential market for BiondVax and a universal flu vaccine may significantly improve public health.  Authorities worldwide recognize that currently marketed influenza vaccines fall short. M-001, which is designed to cover current, future, seasonal and pandemic flu strains, is preparing to enter Phase 3 trials later in 2018.  There is a general recommendation for seasonal influenza vaccination in India for healthcare workers, pregnant women, and people with some chronic illnesses. However, Northern and Southern Hemisphere flu strains dominate at different times and in different regions of the Indian subcontinent. A universal flu vaccine, designed to cover all flu strains, would provide consistent coverage, and be appropriate for vaccination throughout the year.  The patent describes influenza vaccines comprised of multiple copies of several epitopes, such as M-001 which contains nine common and conserved influenza virus epitopes. ]]> <![CDATA[Lupin receives FDA approval for generic Safyral Tablets]]> https://biospectrumindia.com/news/95/10129/lupin-receives-fda-approval-for-generic-safyral-tablets.html https://biospectrumindia.com/news/95/10129/lupin-receives-fda-approval-for-generic-safyral-tablets.html Tue, 02 Jan 2018 16:30:00 +0530 Pharma Major Lupin recently announced that it has received final approval for its Tydemy (Drospirenone, Ethinyl Estradiol, and Levomefolate Calcium Tablets, 3 mg/0.03 mg/0.451 mg and Levomefolate Calcium Tablets, 0.451 mg) from the United States Food and Drug Administration (FDA) to market a generic version of Safyral Tablets of Bayer HealthCare Pharmaceuticals Inc. Lupin’s Tydemy (Drospirenone, Ethinyl Estradiol, and Levomefolate Calcium Tablets, 3 mg/0.03 mg/0.451 mg and Levomefolate Calcium Tablets, 0.451 mg) is the AB rated generic equivalent of Safyral Tablets of Bayer HealthCare Pharmaceuticals Inc. Tydemy is indicated for use by women to prevent pregnancy and to raise folate levels in women who choose to use an oral contraceptive for contraception. Drospirenone, Ethinyl Estradiol, and Levomefolate Calcium Tablets, 3 mg/0.03 mg/0.451 mg and Levomefolate Calcium Tablets, 0.451 mg tablets had annual sales of approximately USD 22.9 million in the US. (IMS MAT October 2017). ]]> <![CDATA[Abbott India to train medical device auditors]]> https://biospectrumindia.com/news/95/10125/abbott-india-to-train-medical-device-auditors.html https://biospectrumindia.com/news/95/10125/abbott-india-to-train-medical-device-auditors.html Tue, 02 Jan 2018 11:40:00 +0530 As part of the Gujarat Food and Drug Administration (FDCA)'s collaboration with Abbott India, hands-on training will be provided to around 62 newly recruited drug inspectors on auditing a medical device manufacturing facility. Gujarat today boasts of having the highest number of 200 plus licensed medical device units under Central Licensing Approval Authority (CLAA) scheme as against a total 284 medical device units in the entire country. The devices currently regulated under CLAA scheme include cardiac stents, drug eluting stents, catheters, intra ocular lenses, I.V. Cannula, bone cements, heart valves, scalp vein set, orthopaedic implants and internal prosthetic replacements. CLAA scheme was formed to oversee the regulatory activities related to grant of manufacturing license for hi- tech medical devices in India. It aims at ensuring that the medical devices being manufactured in India follow the standard requirements set by the government to ensure safety, efficacy and quality of the devices.  Gujarat government had signed eight such strategic partnerships with overseas and Indian companies to upgrade the knowledge of the Gujarat FDCA officers on relevant areas of concern of the regulatory authorities globally and in India. Gujarat FDCA had previously done a similar kind of exercise of training 50 drug inspectors to detect faulty medical devices and sub-standard drugs in line with the training imparted to US FDA inspectors through a collaboration with US-based Underwriters Laboratories (UL). This initiative was led by the compliance education and training services business division of UL, UL EduNeering. ]]> <![CDATA[First generic cream Estrace lanunched by Mylan]]> https://biospectrumindia.com/news/95/10123/first-generic-cream-estrace-lanunched-by-mylan.html https://biospectrumindia.com/news/95/10123/first-generic-cream-estrace-lanunched-by-mylan.html Mon, 01 Jan 2018 12:35:00 +0530 Global pharmaceutical leader Mylan announced the U.S. launch of Estradiol Vaginal Cream USP, 0.01%, the first generic version of Allergan's Estrace® Cream.  Mylan received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product, which is indicated in the treatment of vulvar and vaginal atrophy.  The approval showcases Mylan's ongoing investment in complex products. Mylan is now one of only a few companies that will offer Estradiol as an option across four delivery systems – cream, gel, transdermal patch and tablet.  Estradiol Vaginal Cream USP, 0.01% had U.S. sales of approximately $449 million for the 12 months ending Oct. 31, 2017, according to IQVIA.  Currently, Mylan has 211 ANDAs pending FDA approval representing approximately $93.4 billion in annual brand sales, according to IQVIA. Forty-six of these pending ANDAs are potential first-to-file opportunities, representing $42.1 billion in annual brand sales, for the 12 months ending July 31, 2017, according to IQVIA. ]]> <![CDATA[Lupin’s generic psoriasis treatment approved by USFDA ]]> https://biospectrumindia.com/news/95/10120/lupins-generic-psoriasis-treatment-approved-by-usfda-.html https://biospectrumindia.com/news/95/10120/lupins-generic-psoriasis-treatment-approved-by-usfda-.html Fri, 29 Dec 2017 16:30:00 +0530 Lupin Pharmaceuticals, Inc. is the U.S. wholly owned subsidiary of Lupin Limited, which is among the top five pharmaceutical companies in India. Lupin is developing and delivering a wide range of branded & generic formulations, biotechnology products and APIs globally. The company has received final approval from the US health regulator for its generic version of Dovonex scalp solution used in treatment of psoriasis of scalp.  The approval by the US Food and Drug Administration (USFDA) to Lupin's calcipotriene topical solution is for strength of 0.005 per cent (scalp solution. It is the generic version of Dovonex scalp solution of Lep Pharmaceutical Products Ltd. It is used for topical treatment of chronic, moderately severe psoriasis of the scalp.  Citing IMS data, the company said Calcipotriene topical solution had annual sales of USD 5.9 million in the US till October this year. ]]> <![CDATA[Dr. Reddy's launches Melphalan Hydrochloride for Injection in the U.S. Market]]> https://biospectrumindia.com/news/95/10106/dr-reddys-launches-melphalan-hydrochloride-for-injection-in-the-u-s-market.html https://biospectrumindia.com/news/95/10106/dr-reddys-launches-melphalan-hydrochloride-for-injection-in-the-u-s-market.html Wed, 27 Dec 2017 17:30:00 +0530 Dr. Reddy’s Laboratories Ltd has announced that it has launched Melphalan Hydrochloride for Injection which is a therapeutic equivalent generic version of Alkeran® (melphalan hydrochloride) for Injection in the United States market approved by the U.S. Food and Drug Administration (USFDA). According to IMS Health data, The Alkeran® brand and generic had U.S. sales of approximately $107 million MAT for the most recent twelve months ending in October 2017. Dr. Reddy’s Melphalan Hydrochloride for Injection is available in a carton containing one single dose clear glass vial of freeze-dried melphalan hydrochloride equivalent to 50 mg melphalan and one 10 mL clear glass vial of sterile diluent. ]]> <![CDATA[Sun Pharma’s NDA for OTX-101 accepted by USFDA]]> https://biospectrumindia.com/news/95/10108/sun-pharmas-nda-for-otx-101-accepted-by-usfda.html https://biospectrumindia.com/news/95/10108/sun-pharmas-nda-for-otx-101-accepted-by-usfda.html Wed, 27 Dec 2017 17:30:00 +0530 Sun Pharmaceutical Industries announced that the US FDA has accepted a new drug application (NDA) filed by its US based wholly owned subsidiary for OTX-101 (cyclosporine A, ophthalmic solution) 0.09% It is a novel nanomicellar formulation of cyclosporine A 0.09% in a clear, preservative-free aqueous solution. OTX-101 is now under review for approval by the US FDA and can be an important developmental milestone for Sun Pharma’s dry eye candidate. Previously, in a completed phase 2b/3 clinical trial in 455 patients, OTX-101 demonstrated a rapid onset of action and was well tolerated by the study population. Based on published data, the efficacy and safety endpoints in these trials compared favorably to other formulations of cyclosporine A with the advantage of faster onset. Dilip Shanghvi, managing director, Sun Pharma, said: “Dry eye disease is a complex, chronic condition that affects patient quality of life, often significantly. OTX-101, a novel formulation of cyclosporine, will allow us to participate in the rapidly growing underserved and dynamic dry eye market. When approved, it will be a milestone for millions of dry eye patients across the globe that are yet to find relief for their condition.” Commenting on the development Abhay Gandhi, CEO - North America Business, Sun Pharma, said, “We are excited about the acceptance of this filing by the US FDA. In January 2017, we had announced positive topline results of confirmatory phase-3 clinical trial for OTX-101, demonstrating both efficacy and faster onset of action in a trial environment.” “The 12 week trial saw 744 dry eye patients being treated either with OTX-101, or its vehicle. Compared to the vehicle, OTX-101 showed statistically significant improvement in the primary end point in the trial. The demonstration of efficacy of OTX-101 was earlier than other drugs approved for dry eye in the same class1. We hope to bring OTX-101 to patients in the United States as soon as possible, and look forward to working closely with the US FDA over the coming months”, he added.   ]]> <![CDATA[Dr. Reddy's launched generic cancer injection]]> https://biospectrumindia.com/news/95/10100/dr-reddys-launched-generic-cancer-injection.html https://biospectrumindia.com/news/95/10100/dr-reddys-launched-generic-cancer-injection.html Tue, 26 Dec 2017 17:05:00 +0530 A therapeutic equivalent generic version of Alkeran (melphalan hydrochloride) for Injection is launched by Dr. Reddy’s laboratories in the United States market. The drug, which is used to treat certain types of cancer, was earlier approved by the US Food and Drug Administration (USFDA). According company, IMS Health figures shows the Alkeran brand and generic drug had US sales of approximately $107 million for the most recent twelve months ending in October 2017.  Dr. Reddy's Melphalan Hydrochloride for Injection is available in a carton. The carton consisting of one single-dose clear glass vial of freeze-dried melphalan hydrochloride equivalent to 50 mg melphalan and one 10 mL clear glass vial of sterile diluent. ]]> <![CDATA[Dr. Reddy’s announces its settlement with the US Government]]> https://biospectrumindia.com/news/95/10094/dr-reddys-announces-its-settlement-with-the-us-government.html https://biospectrumindia.com/news/95/10094/dr-reddys-announces-its-settlement-with-the-us-government.html Tue, 26 Dec 2017 11:55:00 +0530 The US subsidiary of Dr. Reddy’s Laboratories Ltd. has announced that it has reached a settlement with the US Government, in a case that is more than six years old, involving packaging for five blister-packed prescription products. In a joint filing by the parties, Dr. Reddy’s and the US Department of Justice agreed to the settlement of the action without any adjudication of any issue of fact or law. In order to avoid any unnecessary costs and the distractions of prolonged litigation, the company has chosen to settle the matter for USD five million. According to the company statement, “Dr. Reddy’s is not aware of any reports that any child gained access to these products as a result of the packaging or that any of the products caused children harm as a result of the packaging. These products have not been distributed in the packaging at issue since June 2012.” “Dr. Reddy’s remains firmly committed to complying with all applicable requirements of the Consumer Product Safety Act, including applicable packaging and reporting requirements.” ]]> <![CDATA[Infertility & contraception, adolescent & behavioral psychology gain traction: Lybrate Report]]> https://biospectrumindia.com/news/95/10090/infertility-contraception-adolescent-behavioral-psychology-gain-traction-lybrate-report.html https://biospectrumindia.com/news/95/10090/infertility-contraception-adolescent-behavioral-psychology-gain-traction-lybrate-report.html Fri, 22 Dec 2017 17:30:00 +0530 Infertility and contraception along with adolescent and behavioral psychology were among the health issues in 2017 that saw a phenomenal growth in terms of interactions with doctors over a year back, as per Lybrate Healthscape India 2017. As per the annual report released recently by Lybrate, India’s first and largest online doctor consultation platform, the number of interactions on infertility and contraception saw a 290% jump as compared to last year, followed by interactions on adolescent and behavioral psychology, which recorded a 265% spike.  In Delhi, 23% people consulted doctors for Infertility and Contraception, while 31% reached out to them for issues related to adolescent/behavioral psychology. In Mumbai, 32% people talked about Infertility and Contraception and 31% consulted healthcare experts about adolescent/behavioral psychology. Kolkata and Ahmedabad had the highest number of queries around Infertility and Contraception with 36% and 35% people, respectively reaching out to doctors for the same. Pune (33%) and Bangalore (24%) also had a significant number of queries on adolescent/behavioral psychology. Diabetes too was a major topic of discussion with 33% people in Bangalore, 32% in Kolkata, 29% in Hyderabad and Chennai and 26% in Delhi and Ahmedabad consulting doctors on Lybrate for the same. Lybrate released the report post analysis of around 80 million interactions, including booking of lab tests that happened on the platform over a period of 12 months, starting January 1 this year.  The other health issues that witnessed a remarkable rise have been: Respiratory Issues (215%), Diabetes & Hypertension (205%), Vitamin and Mineral Deficiency (220%) and Fitness and Wellness (195%). While Tier 1 cities contributed to the growth of interactions on infertility and contraception, majority of interactions from Tier 2 cities led to a staggering growth in interactions in the sexual health category.  Saurabh Arora, Founder and CEO, Lybrate said, “The trend that people are getting concerned and aware about being psychologically healthy and are reaching out to healthcare experts is a positive development. It becomes all the more significant because parents and loved ones too are seeking help for their children and themselves to connect with each other better and fix any behavioral issue. We all ignore our psychological health, not understanding that it is key to our overall good health. Being psychologically healthy saves us from a gamut of lifestyle-triggered diseases that have become a major concern for people across age-groups as also healthcare infrastructure in the country.” “For three years, we have been committedly collating data and churning out useful insights which can play a key role in devising healthcare strategies in accordance with the existing healthcare realities prevalent in the country.”    ]]> <![CDATA[Gleneagles Global Hospitals launch new program in Karnataka]]> https://biospectrumindia.com/news/95/10089/gleneagles-global-hospitals-launch-new-program-in-karnataka.html https://biospectrumindia.com/news/95/10089/gleneagles-global-hospitals-launch-new-program-in-karnataka.html Fri, 22 Dec 2017 16:10:00 +0530 Gleneagles Global Hospitals has announced the launch of their Heart and Lung Transplant program in Karnataka in order to serve the local community and promote the benefits of these procedures. This initiative will help boost the healthcare sector of the state while also build awareness regarding end-stage heart and lung conditions, providing options to those who may not have had viable treatment options in the past. With the launch of this program, Gleneagles Global Hospitals brings to Karnataka the experience of Dr Thasee Pillay, a world renowned cardiothoracic surgeon, and his team of medical professionals experienced in the field of transplants. Dr Thasee Pillay, Advisor & Sr. Consultant Cardiac & Cardiopulmonary Transplant at BGS Gleneagles Global Hospitals, said, “Heart transplantation is a major, critical and complex surgery. It should only be considered if the surgery is going to improve the recipient’s chance of survival or quality of life, post-transplant. Over the years, results have shown that the survival rates of cardiac failure patients have risen from 20% to 80% due to the availability of this procedure, making it a true life-saver and game changer for those patients suffering from heart failure.”  Dr Sandeep HS, Consultant Transplant Pulmonologist at BGS Gleneagles Global Hospitals, said, “There is no way through which lost lung function can be restored completely in respiratory diseases like COPD and ILDs. Despite medical management these diseases continue to progress and the patients eventually end up with respiratory failure. Lung transplantation is the only option to improve quality of life and increase the longevity in such situations. Lung Transplantation is being done worldwide for more than 30 years and the time has come now for our countrymen to utilise this life saving treatment modality.” With the launch of this program, the medical team at Gleneagles Global Hospitals will be available for consultations, assessment, and performance of transplants in the state of Karnataka at their hospitals. Should the necessity present itself, these doctors will also be at hand to do outreach programs to help remote areas of the state. These transplant procedures will follow internationally established protocols, from assessing whether the patient’s condition necessitates a transplant, to assessing the patient’s ability to withstand the procedure, inclusive of evaluation of the damaged organ as well as other organ functions, to identifying and minimising all potential risks that could arise from the performance of these transplant procedures. Dr K Ravindranath, Chairman, Gleneagles Global Hospitals Group said, “With the launch of this transplant program, we hope to educate the public on the benefits of undergoing transplants. These medical procedures offer patients a new lease of life, and a better quality of life than the one they were going through while on medical management. Gleneagles Global Hospitals Group is a pioneering institution in multi organ transplantation in India with cutting edge technology for transplant procedures since it is a world-class transplant center. With our team of experienced medical professionals and a laboratory devoted to transplant immunology, I am sure that this program will be able to benefit all members of the society who need transplant for Heart failure.”   ]]> <![CDATA[To cut down imports India developing bulk drugs]]> https://biospectrumindia.com/news/95/10083/to-cut-down-imports-india-developing-bulk-drugs.html https://biospectrumindia.com/news/95/10083/to-cut-down-imports-india-developing-bulk-drugs.html Thu, 21 Dec 2017 12:30:00 +0530 India is the importer of drugs from China, now it’s time to reduce that import dependence we are in stage to evolve range of bulk drugs.  According to G N Singh, Drug Controller General of India (DCGI); India has adequate ability for producing active pharmaceutical ingredients (API). While India is importing drugs from China in large quantity, we are exporting to most of the developed markets including EU, US and Japan.  “So there is capacity, excepting some of the molecules, where we are working, so that (import) dependency may also be reduced.Threfore, in due course of time that threat would not be there”. Singh said India's bulk drug imports from top five countries stood at Rs. 18,372.54 crore in 2016-17 with China accounting for 66 per cent.  The country's import of APIs from China stood at Rs. 12,254.97 crore in 2016-17, while that from the US was at Rs.820.18 crore.  As per DCGI, India has both capacity and capability to produce APIs although production of some of the bulk drugs was curtailed, driven by market dynamics. "If need arises, the industry, the regulator, the scientific fraternity and the government are ready to meet the challenges," Singh said.  The regulator is constantly engaged with the industry on ways to address the issue, he added.  "It is an issue but not something, which cannot be solved," Singh said.  The challenges are faced by Indian pharmaceutical industry in terms of scrutiny by regulators from across the world. Singh Commented on these regulations “It is good. When you are growing, you should be ready for scrutiny and when other regulators are coming it gives opportunity to address our weakness and convert it into strength."  The industry should take it as an opportunity, he added. ]]> <![CDATA[Strides Shasun procures Controlling Stake In Trinity Pharma]]> https://biospectrumindia.com/news/95/10077/strides-shasun-procures-controlling-stake-in-trinity-pharma.html https://biospectrumindia.com/news/95/10077/strides-shasun-procures-controlling-stake-in-trinity-pharma.html Wed, 20 Dec 2017 17:45:00 +0530 Strides Shasun, is an Indian pharmaceutical company, headquartered at Bangalore, India. The company manufactures pharmaceutical products, over-the-counter drugs and nutraceuticals. The company announced its subsidiary has entered into an agreement to acquire controlling stake in South Africa's Trinity.  According to stides Shasun, Strides Pharma Asia Pte, Singapore, a wholly-owned subsidiary of Strides Shasun has entered into definitive agreements with Trinity Pharma Proprietary, South Africa for acquisition of controlling stake in Trinity.  Strides Pharma Asia Pte will acquire 55 per cent stake in Trinity for a cash consideration of South African Rand 55 million (approximately Rs 27.5 crore)  The company said the transaction allows Strides to establish presence in the high entry barrier market of South Africa, where product dossiers approval takes more than five years. This transaction will provide access to pipeline of more than 110 product dossiers already submitted.  The transaction is subject to customary closing conditions including approvals from the South African regulatory authority and is expected to close on or before 5 January 2018. ]]> <![CDATA[Rohit Sathe appointed as president of Philips India Healthcare]]> https://biospectrumindia.com/news/95/10075/rohit-sathe-appointed-as-president-of-philips-india-healthcare.html https://biospectrumindia.com/news/95/10075/rohit-sathe-appointed-as-president-of-philips-india-healthcare.html Wed, 20 Dec 2017 15:05:00 +0530 Philips India has announced the appointment of Mr. Rohit Sathe as President in Philips India Healthcare. The designation is operational from December 4th, 2017. Rohit will be a part of the Philips India Leadership team and will be responsible for bringing in leadership experience and extensive industry knowledge to contribute to Philips’ overall growth plans. He will administer key initiatives to improve access to healthcare in the areas of prevention, diagnostics and treatment.  Almost two decades of work experience in the healthcare, Rohit Sathe is also having knowledge and experience of construction and e-learning industries in India and UK. He has joined Philips from Johnson & Johnson Medical India (JJMI) where his last role was Senior Director of Strategy, Key Accounts and International (SAARC) Business. He has vast awareness and understanding of healthcare as he worked in the Cardiology, Orthopaedics and Neuro segments for12+ years of tenure at J&J. His achievements include launching coronary drug eluting stents (DES), integrating the recently acquired Synthes business into J&J and turning around and improving profitability of the Trauma and Neuro businesses. Philips target of touching 200 million patients in India by 2025 will be in reach by Rohit Sathe’s presence, as he is having ironic experience in sales, marketing strategy and project management across diverse industries. ]]> <![CDATA[BD launches a campaign to encourage usage of safety engineered devices]]> https://biospectrumindia.com/news/95/10074/bd-launches-a-campaign-to-encourage-usage-of-safety-engineered-devices.html https://biospectrumindia.com/news/95/10074/bd-launches-a-campaign-to-encourage-usage-of-safety-engineered-devices.html Wed, 20 Dec 2017 13:55:00 +0530 To encourage the usage of safety engineered devices, BD is organizing a ‘Santa Says…Stay Sharp Be Safe’ pan India campaign. Aligned with its commitment towards safety of healthcare workers, the campaign will run during December 20-31 to spread awareness of healthcare worker safety across hospitals such as Medanta, Gangaram, Artemis, Columbia Asia, Apollo, PSRI, ESI, BLKapur to name a few in Delhi. Realising the occupational hazards faced by workers in a healthcare setup, BD had initiated this campaign last year. This year, the campaign focuses on the issues faced by healthcare workers – needle stick injuries including exposure to bloodborne pathogens such as HIV/AIDS and hepatitis, being the most highest of all. According to a study, India contributes to 30% of the 16 billion injections administered worldwide. Sadly, of these, 63% are estimated to be unsafe due to improper sterilization, reuse or faulty administration, making them a leading cause of infection to healthcare workers. There have been epidemics of Hepatitis B and Hepatitis C in many parts of the country due attributable to reuse of syringes and needles. Dr. Deepak Singla, Medical Director, Maharaja Agrasen Hospital, NABH Assessor (QCI), JCI Accreditation Coordinator, New Delhi says” Injuries from blood-filled needles is the major reason because of which healthcare workers become vulnerable to blood borne pathogens and life- threatening diseases. Needles are mostly used in performing high-risk procedures like drawing blood, intravascular catheterization etc. The good news is that majority of the infections through needle stick injuries are preventable. Program like this one from (BD) like Santa Says… Stay Sharp, Be Safe campaign focusing on education and training of healthcare workers pertaining to needle stick injury prevention and use of safety engineered devices can go a long way in bringing down the incidence of infections.” A study undertaken in AIIMS Trauma centre in 2014 showed about 36% of doctors, 14.6% of nurses and 7% of housekeeping staff had accidental needle stick injuries. Moreover, a policy guidance released by the WHO in February 2015 highlighted needle- stick injury as one of the major issues and have advocated for the use of Sharps Injury Protection (SIP) devices. This policy also provides guidance to key stakeholders that play a critical role in the adoption and implementation of safe injection practices, i.e., in endorsing the policy, manufacturing the devices, ensuring their procurement and distribution at the country level, promoting their correct use by health-care providers and their evaluation in terms of safety and effectiveness Vishal Taneja, Business Director-BD Medical, BD in India commented, “Backed by 120 years of tradition and heritage in safety, BD brings an expertise in manufacturing high quality safety-engineered medical devices that is unrivaled. With ‘Santa says..Stay Sharp Be Safe’ campaign across hospitals this festive season, we would seek to advance the right spirit of education and training on infection prevention and control, including needlestick and sharps safety, use of safety-engineered devices for better clinical practices and also enhance our engagement to protect healthcare workers from sharps injuries in the country. BD’s portfolio of safety devices for blood collection, injection, infusion, and sharps collection helps ensure patient safety and healthcare provider protection from the risks associated with unsafe practices.”     ]]> <![CDATA[Abbott launches first insertable cardiac monitor to detect Arrhythmias]]> https://biospectrumindia.com/news/95/10068/abbott-launches-first-insertable-cardiac-monitor-to-detect-arrhythmias.html https://biospectrumindia.com/news/95/10068/abbott-launches-first-insertable-cardiac-monitor-to-detect-arrhythmias.html Wed, 20 Dec 2017 10:55:00 +0530 With the new Insertable Cardiac Monitor (ICM), physicians can remotely monitor their patients for even the most difficult to detect cardiac arrhythmias, including irregular heartbeats Healthcare company Abbott has recently launched the latest in Insertable Cardiac Monitor (ICM) across India, providing patients access to the world's first and only smartphone compatible ICM. The technology is designed to help physicians remotely identify cardiac arrhythmias. Abbott’s latest ICM is the world’s first smartphone compatible ICM to help physicians identify even the most difficult to detect cardiac arrhythmias, including atrial fibrillation (AF), in order to help guide appropriate therapy. It is designed to continuously monitor a patient's heart rhythm and proactively transmit information via Bluetooth® wireless technology to Abbott’s dedicated mobile app for this, allowing physicians to follow their patients remotely and accurately diagnose arrhythmias that may require further treatment. The device has already received the CE Mark and USFDA approvals and is available in the EU, USA, as well as Australia. Speaking on the importance of the device, Dr. Balbir Singh, Chairman of Medanta Hospital said, “The insertable cardiac monitor is extremely useful, because as the smallest cardiac care device which can diagnose some unknown, yet dangerous heart rhythm problems, it provides early diagnosis and timely treatment to events which could be catastrophic.” An arrhythmia is an abnormal heart rhythm that develops when disease or injury disrupts the heart's electrical signals, causing the heart to beat erratically. As the heart begins to beat too fast or too slow, changes in blood flow can expose patients to symptoms such as palpitations, dizziness, shortness of breath or even sudden death. Ajay Singh Chauhan, General Manager, India & Subcontinent, Abbott-St. Jude Medical says, “This new ICM is taking cardiac monitoring to a whole new level. The device provides patients a new way to monitor for abnormal heart rhythms while staying connected to their physician remotely and engaged in their health care. For physicians, the device allows for effective management of patients while enhancing patient compliance through smartphone connectivity.  If left undetected, arrhythmias can lead to additional – and often serious – complications for patients.” At times, it is not easy to determine infrequent arrhythmias. Dr. Aparna Jaswal, Associate Director at Fortis-Escorts Heart Institute, New Delhi says, “The ICM can help us diagnose patients having infrequent, but potentially fatal episodes of cardiac arrhythmias and choose the appropriate treatment modalities for such patients.” Once implanted—just under the skin in the chest during a quick, minimally-invasive outpatient procedure—the Abbott ICM continuously monitors heart rhythms to detect a range of cardiac arrhythmias, including irregular heartbeats, or atrial fibrillation, and is the slimmest ICM available today. It is the size of two paper clips, stacked on top of each other. The device also allows patients to avoid a separate or cumbersome recording device, which is often the requirement. Reiterating this, Dr. Vanita Arora, Director and Head, Max Hospital, Saket, New Delhi says, “Having a smart phones enabled patient activator increases compliance and leads to better correlation between symptoms and cardiac rhythm.” While the ICM continuously monitors for abnormal heart rhythms and transmits data to a patient’s physician, the app also allows patients to track symptoms proactively, sync their data with their clinic at any time, and view their transmission history without having to contact their clinic to confirm successful data transfers. Patients can also record their symptoms such as fainting spells or heart palpitations in the app on their smart phones, to complement the information being monitored by the device. ICM helps enhance patient compliance, without additional clinic burden. Thus it can effectively manage patients from a simple insertion procedure to streamlined remote follow-up.   ]]> <![CDATA[Marken expands its presence in India ]]> https://biospectrumindia.com/news/95/10063/marken-expands-its-presence-in-india-.html https://biospectrumindia.com/news/95/10063/marken-expands-its-presence-in-india-.html Tue, 19 Dec 2017 17:35:00 +0530 Marken made an announcement that it is going to open new branch in Ahmedabad and expand into larger spaces in Hyderabad and Delhi. Both offices will be operational in the first quarter, 2018. The opening of office will beneficial to fulfill client demand and also enables further expansion of its transportation network in the country. Marken will have six fully equipped locations in India, including its 24/7 Global Control Center in Mumbai.   The Indian biotech industry holds a 2% share of the global biotech market, but is growing fast. This growth is still continuing due to growing demand, rigorous R&D and various government initiatives. India is among the top 12 biotech destinations in the world and ranks third in the Asia-Pacific region. India has the second-highest number of US Food and Drug Administration (USFDA)–approved manufacturing plants, after the USA. India has emerged as a leading source of drug manufacturing but is also a growing destination for clinical trials and contract research. ]]> <![CDATA[Biocon plans investment in UP’s health sector]]> https://biospectrumindia.com/news/95/10059/biocon-plans-investment-in-ups-health-sector.html https://biospectrumindia.com/news/95/10059/biocon-plans-investment-in-ups-health-sector.html Tue, 19 Dec 2017 16:25:00 +0530 Biopharma company Biocon is planning to invest in the healthcare centres of Uttar Pradesh and encourage entrepreneurs in the biotech space, especially the startups, to work in the state. Accroding to the company, a survey should be conducted in all districts of UP, including Gorakhpur, for starting e-health care centres under a pilot project. A campaign should also be launched to attract investors in the health sector. UP's industrial development minister Satish Mahana stated that UP has increased the limit of start-up corpus fund from Rs 100 crore to Rs 1,000 crore. These developments took place during the second road show that was held in Bengaluru as a precursor for the Investment Meet to be held in Lucknow on February 21 and 22, 2018. ]]> <![CDATA[Govt awards patent to Lincoln Pharma]]> https://biospectrumindia.com/news/95/10057/govt-awards-patent-to-lincoln-pharma.html https://biospectrumindia.com/news/95/10057/govt-awards-patent-to-lincoln-pharma.html Tue, 19 Dec 2017 14:25:00 +0530 Government has awarded a patent to Gujarat based Lincoln Pharmaceuticals for anti-malarial drug in India. The patent has been awarded for an Arteether injection to treat malaria. The drug is painless and gives faster relief to the patients. The company expects significant rise in the revenue from exports to Africa after the introduction of this injection in the African market. With the introduction of this injection in African countries, where total anti-malarial market is Rs. 586 crore, the company expects to increase revenue from Africa by Rs. 35-40 crore. At present, the company’s anti-malarial drug exports to Africa amounts to Rs. 50 crore. The Research & Development center at Lincoln is furnished with state-of-the-art devices and equipments for internal physical, chemical and microbiological analysis of all products. ]]> <![CDATA[Dr Reddy's makes settlement with US Govt]]> https://biospectrumindia.com/news/95/10054/dr-reddys-makes-settlement-with-us-govt.html https://biospectrumindia.com/news/95/10054/dr-reddys-makes-settlement-with-us-govt.html Tue, 19 Dec 2017 11:25:00 +0530 The US subsidiary of Dr. Reddy’s Laboratories Ltd. has reached a settlement with the US Government, in a case that is more than six years old, involving packaging for five blister-packed prescription products. In a joint filing by the parties, Dr. Reddy’s and the US Department of Justice agreed to the settlement of the action without any adjudication of any issue of fact or law. Dr. Reddy’s has taken this investigation seriously, cooperating with the Government over the past six years. The safety of patients and consumers is of paramount importance to Dr. Reddy’s, and the Company firmly disagrees with the Government’s allegations. However, in order to avoid any unnecessary costs and the distractions of prolonged litigation, the company has chosen to settle the matter for USD five million. Dr. Reddy’s is not aware of any reports that any child gained access to these products as a result of the packaging or that any of the products caused children harm as a result of the packaging.  These products have not been distributed in the packaging at issue since June 2012. Dr. Reddy’s remains firmly committed to complying with all applicable requirements of the Consumer Product Safety Act, including applicable packaging and reporting requirements.  ]]> <![CDATA[Sanofi India Limited appoints N. Rajaram as Managing Director]]> https://biospectrumindia.com/news/95/10045/sanofi-india-limited-appoints-n-rajaram-as-managing-director.html https://biospectrumindia.com/news/95/10045/sanofi-india-limited-appoints-n-rajaram-as-managing-director.html Fri, 15 Dec 2017 17:00:00 +0530 Sanofi India Limited (SIL) announced the elevation of N. Rajaram as the Managing Director of the Company, with effect from 1st January, 2018. His appointment was approved by the Sanofi India Board of Directors earlier. N. Rajaram joined Sanofi India in February 2014 and was appointed as Whole Time Director in October 2015. Under his leadership, the Company has doubled the size of its diabetes business and established a foothold in the consumer healthcare sector, while significantly transforming its market operations.  Rajaram brings with him diverse experience of nearly two decades in the FMCG industry with Hindustan Unilever, and in the telecom industry with Airtel. Rajaram holds a bachelor’s degree in Engineering from the Birla Institute of Technology & Science (BITS), Pilani, India and an MBA in International Business from the Indian Institute of Foreign Trade (IIFT), New Delhi. He is also an alumnus of the Advanced Managed Program of the Harvard Business School.  N. Rajaram succeeds Dr. Shailesh Ayyangar who has been the Managing Director of Sanofi India Limited for over 12 years. Dr. Ayyangar will take up a new role in the Sanofi Asia region effective January 1st, 2018. He will also continue as a Non-Executive Director on the Board of Sanofi India Limited.  Speaking about the transition, Dr. Ayyangar said, “I am truly grateful for the trust and confidence reposed on me over the years, by Sanofi India Limited’s shareholders, and other stakeholders including our employees and the senior leadership within Sanofi. It has been a real privilege to serve the Company and the country over a long period.” He further added that “While I am looking forward to taking on a new position in Sanofi Asia region, I am delighted to welcome N. Rajaram as the new Managing Director of SIL. This transition has been planned well in advance and I am very confident that under his leadership, SIL will scale greater heights of performance and continue to serve the patients of our country”.  Speaking on the occasion, N. Rajaram said, “Sanofi is a great global organization, which is focused on delivering transformational outcomes for patients based on scientific innovation and improved access to healthcare solutions. Our people have a contagious commitment and passion to empower the lives of the millions of patients we serve, making Sanofi an exciting and purposeful place to work. I’m thrilled to be part of this journey and hope to steer the Company through its next phase of growth”. ]]> <![CDATA[MedGenome receives Accreditation from College of American Pathologists (CAP)]]> https://biospectrumindia.com/news/95/10029/medgenome-receives-accreditation-from-college-of-american-pathologists-cap.html https://biospectrumindia.com/news/95/10029/medgenome-receives-accreditation-from-college-of-american-pathologists-cap.html Wed, 13 Dec 2017 17:45:00 +0530 CAP Accreditation is awarded to Clinical Laboratories Meeting the Highest Standards in Quality Laboratory Practices Diagnostics company, MedGenomd has announced today that its NGS (Next Generation Sequencing) technology based clinical laboratory in Bangalore has been awarded accreditation from the College of American Pathologists (CAP) based on the results of an on-site inspection. The CAP Laboratory Accreditation Program is a globally recognized program and is the only one of its kind that utilizes teams of practicing laboratory professionals as inspectors and is designed to go well beyond regulatory compliance. During the accreditation process, inspectors do a detailed check of the laboratory’s records and quality control procedures. They also assess the laboratory’s staff competency/qualifications, equipment, facilities, safety program, and overall management to ensure it meets CAP’s broad and stringent quality criteria. This accreditation is awarded to facilities meeting the highest standard of excellence in clinical laboratory practices. With this accreditation, MedGenome’s India laboratory joins the ranks of the most elite laboratories in the world. Dr. V.L Ramprasad, COO MedGenome said, “Being awarded the accreditation by CAP is an extremely proud moment for us. It further validates our commitment to provide the highest standards in quality laboratory services. Having launched India’s first validated Liquid biopsy and the carrier screening tests, we are trying to find answers to some of the most complex diseases. We strive to provide the most accurate results    based on thorough and rigorous processes to clinicians across India, so that they can produce the best outcomes for patients”.  With this accreditation, MedGenome is the only Indian laboratory to be CAP accredited for Whole genome/exome sequencing, CfDNA (Cell free DNA) testing for liquid biopsy and NIPT (Non-invasive prenatal screening test) and high resolution HLA typing.   ]]> <![CDATA[Novo Nordisk India and Torrent Pharma expand their insulin manufacturing facility ]]> https://biospectrumindia.com/news/95/10030/novo-nordisk-india-and-torrent-pharma-expand-their-insulin-manufacturing-facility-.html https://biospectrumindia.com/news/95/10030/novo-nordisk-india-and-torrent-pharma-expand-their-insulin-manufacturing-facility-.html Wed, 13 Dec 2017 17:45:00 +0530 Novo Nordisk India and Torrent Pharmaceuticals on Monday announced expansion of their insulin manufacturing facility at the latter's Indrad factory, 40 kms from state capital Gandhinagar. Currently reaching out to 3mn patients, the expansion would enable Novo Nordisk to tap 5 mn patients, Melvin D'souza, Managing Director, Novo Nordisk India said. The facility was inaugurated by Peter Taksoe-Jensen, Ambassador to India, Embassy of Denmark, Jinesh Shah, Executive Director, Torrent Pharmaceuticals, Frederik Kier, Senior Vice President, Region AAMEO, Novo Nordisk, and Melvin D'souza, Managing Director, Novo Nordisk India. The new facility will increase capacity by 35%. The plant was producing 26 mn vials. "With the expansion of the facility at Indrad, we reiterate our commitment to ensuring the provision of affordable, quality insulin for people with diabetes. At Novo Nordisk, we are committed to addressing the growing diabetes burden by working with likeminded stakeholders to change diabetes," said Frederik Kier, Senior Vice President, Region AAMEO, Novo Nordisk. D'souza said: "The growth of diabetes in India is alarming and people with diabetes have a right to access affordable, quality medication. Through this partnership, we will continue to ensure the provision of cost-effective yet high-quality medication." Torrent Pharmaceuticals and Novo Nordisk began their partnership 25 years ago in 1992 with the manufacture and launch of insulin in 40 IU vials. In 2009, an integrated manufacturing and vial packaging plant was inaugurated.   ]]> <![CDATA[Merck joined hands with Avanti Polar Lipids ]]> https://biospectrumindia.com/news/95/10018/merck-joined-hands-with-avanti-polar-lipids-.html https://biospectrumindia.com/news/95/10018/merck-joined-hands-with-avanti-polar-lipids-.html Tue, 12 Dec 2017 14:25:00 +0530 Merck is a leading science and technology company in healthcare, life science and performance materials. Company announced that it has entered into an agreement with Avanti® Polar Lipids. It will be exclusive multinational distributor of the USA-based company's research lipids portfolio outside of the United States.  Under the terms of the agreement, Merck will employ its sales, marketing and e-commerce expertise to distribute Avanti® Polar Lipids research lipid portfolio. The distribution agreement includes all regions worldwide, except for the United States, where Avanti® Polar Lipids will continue to reach customers via its own channels. Financial details were not disclosed.  "High-quality lipids are an essential component of precision in the laboratory. Avanti Polar Lipids' research lipids strengthen Merck's overall Life Science portfolio, giving our customers access to a broad portfolio of the highest purity lipids on the market." said Klaus Bischoff, Head of the Research Solutions business area, Life Science at Merck.  Merck offers a complete portfolio of products and solutions that enable scientific discovery, including life science reagents and kits, lab and specialty chemicals and lab separation and workflow tools.  Avanti® Polar Lipids is a leading manufacturer and supplier of the highest purity lipids for research and pharmaceutical product development. Through this agreement, customers outside of the United States will have enhanced on-demand access to the Avanti® research lipid portfolio. The access will make available through life science business of Merck's robust e-commerce platform, SigmaAldrich.com, regional inventory and company sales representatives. Products will be stocked globally for improved availability to customers.  Transition of approximately 2,000 products from the Avanti® research lipid portfolio to Merck is expected to be completed in early 2018. In the interim, these products will continue to be available through existing Avanti® Polar Lipids' channels. Avanti® lipidomics products included in this agreement provide a new approach to answer fundamental questions about lipid structure and function and meet the demands of lipid researchers. ]]> <![CDATA[Novo Nordisk and Torrent expand insulin facility]]> https://biospectrumindia.com/news/95/10013/novo-nordisk-and-torrent-expand-insulin-facility.html https://biospectrumindia.com/news/95/10013/novo-nordisk-and-torrent-expand-insulin-facility.html Tue, 12 Dec 2017 10:45:00 +0530 Novo Nordisk India and Torrent Pharmaceuticals recently announced the expansion of their insulin manufacturing facility at Torrent's Indrad factory. The facility was inaugurated by Peter Taksoe-Jensen, Ambassador to India, Embassy of Denmark, Jinesh Shah, Executive Director, Torrent Pharmaceuticals, Frederik Kier, Senior Vice President, Region AAMEO, Novo Nordisk, and Melvin D'souza, Managing Director, Novo Nordisk India. Novo Nordisk believes that this expansion would enable the company to tap 5 million patients as compared to 3 million currently. Torrent Pharmaceuticals and Novo Nordisk began their partnership 25 years ago in 1992 with the manufacture and launch of insulin in 40 IU vials. In 2009, an integrated manufacturing and vial packaging plant was inaugurated. As world leaders in diabetes care, Novo Nordisk partners with patients, policymakers, healthcare professionals and non-governmental organisations to address diabetes risk factors, thus ensuring that people with diabetes are diagnosed earlier. Through the Changing Diabetes Barometer project, Novo Nordisk has partnered with seven state governments to create awareness about diabetes. As part of the project, till date, 700,000 people have been educated about diabetes and over 3700 doctors and paramedics have been trained through various capacity building programs ]]> <![CDATA[‘Alcon More to See’ survey released by Alcon]]> https://biospectrumindia.com/news/95/10011/alcon-more-to-see-survey-released-by-alcon.html https://biospectrumindia.com/news/95/10011/alcon-more-to-see-survey-released-by-alcon.html Mon, 11 Dec 2017 17:35:00 +0530 Division of Novartis and global leader in eye care, Alcon has released the ‘Alcon More to See’ survey that highlights the critical gaps in the knowledge and awareness of cataracts across six Asian countries, including India. Despite cataracts being a leading cause of vision impairment in the above 60+ age-groups in India and other parts of Asia, senior citizens surveyed revealed high levels of ignorance or incorrect beliefs with regards to cataracts and their progression. According to the survey, “The knowledge that age–related cataracts are a progressive disease, a part of aging and can lead to visual impairment and blindness unless treated was missing. In fact, when it comes to eye check-ups, many senior citizens revealed that they do not regularly consult with an eye care professional. This, even when over 96 percent Indians in this age-group revealed that when compared to touch, taste, scent and hearing, vision is the most important of the five senses.” “The majority of senior citizens, 77% understand that cloudy vision is a symptom of cataract. Yet almost half (42%) of the Indian respondents were unable to name even one symptom. Plus, 16% erroneously listed itchy eyes as a symptom”, survey says Sandeep Bothra, Country Business Head – Surgical said, “While lifestyle factors may impact cataract, it’s a progressive disease that can only be treated by surgery. Alcon is encouraging people 50 years and up to get their eyes checked annually. Annual check-ups are very important for seniors and it worries us that so few are regularly seeing an eye care professional.” Interestingly, when compared to their Asian peers, Indian respondents showed significantly higher levels of awareness when it came to having a full understanding of cataract (37%) compared to an average of 22% across the rest of the Asia region.The number of respondents with ‘no knowledge at all’ on cataract was considerably lower in India, at 3% compared to 7% for the Asia region.   ]]> <![CDATA[Novartis announces Scapho data]]> https://biospectrumindia.com/news/95/10010/novartis-announces-scapho-data.html https://biospectrumindia.com/news/95/10010/novartis-announces-scapho-data.html Mon, 11 Dec 2017 17:25:00 +0530 Novartis has announced new long-term Scapho (secukinumab) data for patients with Ankylosing Spondylitis (AS). This study is unique as these data show, for the first time with any biologic, that almost 80 percent of AS patients treated with Scapho have no radiographic progression (mSASSS <2) of the spine at 4 years. The new data also confirm sustained improvement in signs and symptoms in almost 80 percent of patients, while Scapho delivers a favorable and consistent safety profile. The new data was presented as a late-breaker during the 2017 American College of Rheumatology/Association of Rheumatology Health Professionals (ACR/ARHP) Annual Meeting in San Diego, United States. Jawed Zia, Country President, Novartis India said, “Staying true to our philosophy of Winning for Patients, these data now give us an opportunity to fulfil the unmet needs of people suffering with ankylosing spondylitis. Chronic and disabling conditions such as these impact the productive years of people. With Scapho we are now even more confident of offering patients an active life with enhanced mobility.” Secukinumab is the first and only fully human IL-17A inhibitor approved to treat AS, PsA and psoriasis. Secukinumab is a targeted treatment that specifically inhibits the IL-17A cytokine, which plays a significant role in the pathogenesis of AS, PsA and plaque psoriasis. Recognizing these data findings as a pivotal milestone in treatment for ankylosing spondylitis, Dr. Jyotsna Oak, Consultant Internal Medicine and Rheumatology, Kokilaben Dhirubhai Ambani Hospital said, “Nearly 30 – 40 lakh people in India suffer from ankylosing spondylitis. It results in serious impairment of movement impacting the quality of life. Young working population is most commonly affected. It is important that the disease is diagnosed and treated at an early stage in order to control disease progression. This promising data boosts our confidence to improve outcomes in Ankylosing Spondylitis patients from a long-term perspective.” In India, Secukinumab is known as Scapho and it was approved for the treatment moderate-to-severe plaque psoriasis in October 2015 and for the treatment of AS and PsA in January 2017.     ]]> <![CDATA[Lupin, Cadila Healthcare recall drugs in US]]> https://biospectrumindia.com/news/95/10002/lupin-cadila-healthcare-recall-drugs-in-us.html https://biospectrumindia.com/news/95/10002/lupin-cadila-healthcare-recall-drugs-in-us.html Sun, 10 Dec 2017 19:25:00 +0530 Drug firms Lupin and Cadila Healthcare are recalling nearly 1.11 lakh units of Duloxetine delayed-release capsules and 19,812 bottles of Paroxetine tablets, respectively, from the US market, the US health regulator has said. Lupin Pharmaceuticals is recalling 1,11,648 units of Duloxetine delayed-release capsules USP, in the strength of 30 mg, on account of failed dissolution specification, the United States Food and Drug Administration (USFDA) said in its latest Enforcement Report. The drug was manufactured by Lupin Goa, the report added. The ongoing voluntary nationwide recall is a class III recall, it said. Zydus Pharmaceuticals USA Inc, arm of Cadila Healthcare, is also recalling 19,812 bottles of Paroxetine tablets in the strength of 30 mg from the US market. The reason for the ongoing voluntary nationwide recall is "presence of foreign tablets/capsules: Risperidone tablets were found in bottle of Paroxetine tablets", the report stated. The product was manufactured by Cadila Healthcare and the recall is a class II recall, the regulator added. A class II recall is initiated in a "situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote". A class III recall, on the other hand, kicks in where use of or exposure to a violative product is not likely to cause adverse health consequences. ]]> <![CDATA[Glenmark initiates myeloma drug trial]]> https://biospectrumindia.com/news/95/9998/glenmark-initiates-myeloma-drug-trial.html https://biospectrumindia.com/news/95/9998/glenmark-initiates-myeloma-drug-trial.html Fri, 08 Dec 2017 15:20:00 +0530 Glenmark Pharma has initiated the phase-1 clinical trial of GBR 1342, an investigational antibody for treatment of multiple myeloma. GBR 1342 is an investigational new drug from the company's immuno-oncology portfolio. Glenmark had received clearance from US health regulator in May this year, for the investigational new drug application to initiate phase-1 study of GBR 1342. This first-in-human, open-label study's primary objective is to assess the safety and tolerability of increasing doses of GBR 1342 in multiple myeloma patients until a maximum tolerated dose is reached. The additional study objectives include assessment of biomarkers, immunogenicity and additional measures of anti- tumour activity. ]]> <![CDATA[Suven Life Sciences secures product patents in Eurasia and Norway]]> https://biospectrumindia.com/news/95/9990/suven-life-sciences-secures-product-patents-in-eurasia-and-norway.html https://biospectrumindia.com/news/95/9990/suven-life-sciences-secures-product-patents-in-eurasia-and-norway.html Thu, 07 Dec 2017 16:25:00 +0530 Suven Life Sciences has been granted product patents each from Eurasia and Norway which corresponds to the new chemical entities for the treatment of disorders associated with neurodegenerative diseases. These patents are valid through 2034 and 2026, respectively, said the company in a BSE filing. The granted claims of the patents include the class of selective 5-HT6 compounds and are being developed as therapeutic agents and are useful in the treatment of cognitive impairment associated with neurodegenerative disorders like Alzheimer’s disease, Attention deficient hyperactivity disorder (ADHD), Huntington’s disease, Parkinson and Schizophrenia. Venkat Jasti, CEO of Suven said, “We are very pleased by the grant of these patents to Suven for our pipeline of molecules in CNS arena that are being developed for cognitive disorders with high unmet medical need with huge market potential globally." Shares of Suven Life Sciences saw a rise in 5%and ended at Rs 197.15on the BSE. ]]> <![CDATA[Mylan launches HepBest for chronic hepatitis B treatment]]> https://biospectrumindia.com/news/95/9988/mylan-launches-hepbest-for-chronic-hepatitis-b-treatment.html https://biospectrumindia.com/news/95/9988/mylan-launches-hepbest-for-chronic-hepatitis-b-treatment.html Thu, 07 Dec 2017 15:35:00 +0530 Mylan Pharmaceuticals Private Limited has launched HepBest 25 mg (tenofovir alafenamide, TAF), a once-daily tablet for the treatment of chronic hepatitis B in adults. According to World Health Organization (WHO) estimates, more than 2 billion people worldwide are infected with the hepatitis B virus (HBV), of which more than 240 million have chronic liver infection. These patients are at risk of developing serious illness and death, largely resulting from liver cirrhosis and liver cancer. HepBest (TAF) is the first drug in eight years to be approved for the management of chronic hepatitis B in India. TAF demonstrates comparable efficacy with an enhanced renal and bone safety profile as compared to the earlier formulation of tenofovir (tenofovir disoproxil fumarate). TAF also has greater plasma stability, which ensures efficient drug delivery to the site of action. Commenting on the launch, Rakesh Bamzai, President, India and Emerging Markets said, “India has an estimated 40 million HBV carriers, of which 15% to 25% could go on to suffer from cirrhosis and liver cancer. Mylan continues to be in the forefront of introducing new treatment regimens for the management of hepatitis in India. By bringing the best-in-class drug for hepatitis B management, HepBest, to India, Mylan hopes to provide care for chronic hepatitis B patients and improve overall management of the disease.” In 2014, Mylan signed an agreement with Gilead to enhance access to TAF-based HIV treatments in developing countries. As part of the licensing agreement, on U.S. Food and Drug Administration (FDA) approval, Mylan received a technology transfer from Gilead, enabling it to manufacture low-cost versions of TAF. ]]> <![CDATA[Gleneagles Global Hospitals launched mobile stroke exhibition ]]> https://biospectrumindia.com/news/95/9972/gleneagles-global-hospitals-launched-mobile-stroke-exhibition-.html https://biospectrumindia.com/news/95/9972/gleneagles-global-hospitals-launched-mobile-stroke-exhibition-.html Tue, 05 Dec 2017 21:00:00 +0530 In an attempt to increase stroke awareness, Gleneagles Global Hospitals has set up a Stroke “Museum on the Move” in Bangalore The exhibition consisting of 13 informational poster is set to circulate throughout various locations in the city. It began its journey on October 29th, also observed as World Stroke Day, at BGS Gleneagles Global Hospitals in Kengeri. Gleneagles Global Hospitals is part of Parkway Pantai, a fully owned subsidiary of IHH Healthcare. In India, Gleneagles Global Hospitals operates a chain of multi-super specialty hospitals in Hyderabad, Chennai, Bangalore and Mumbai. The exhibition consists of 13 informational posters that cover all the basic facts and information one needs regarding strokes. The information provided follows the flow right from what the brain is to what a stroke is to stroke symptoms, diagnosis, treatment, rehabilitation, and prevention. The exhibition also provides additional information on strokes regarding neurosonology and the role of neurosurgery in the diagnosis and treatment of strokes. The posters supply information in both English and Kannada, in order to have a larger effect on the overall population of Bengaluru. The final poster demands a call-to-action, requiring each and every audience member to take a pledge to create and spread stroke awareness. In addition to these posters, awareness talk sessions were organized by Dr Suryanarayana Sharma, Consultant Neurologist and Stroke Specialist at BGS Gleneagles Global Hospitals. The exhibition was previously displayed at Mindtree in the Global Village Tech Park, where it remained until November 30th. It was then moved to Bosch at Bidadi, where it will be displayed until December 7. Previously, the exhibition was also displayed at BGS Gleneagles Global Hospitals, Kengeri and Lalbagh gate. The exhibition was open to employees of Mindtree, but the exhibition at Kengeri and Lalbagh was open to the general public, helping Gleneagles Global Hospitals edge closer to its mission of spreading awareness to 15,000 residents of the city. Volunteers were present at the event to guide the audience and help them understand the information from the posters. As per Dr Suryanarayana Sharma, “Stroke is the 3rd leading cause of death worldwide, and has been declared a global emergency. Every year, hospitals and medical organization take initiatives around the world take steps to promote stroke awareness on 29th October, which is World Stroke Day. BGS Gleneagles Global Hospitals, which has been a stroke-ready and stroke-conscious hospital for over a decade now, had also hosted a 10k run and a 3 km walkathon to promote stroke awareness in the city, in addition to organizing this exhibition.” Thomas Mathew, COO, Gleneagles Global Hospitals, Bengaluru adds “Gleneagles Global Hospitals has been very active in tackling the problem of strokes within the Bengaluru community. The hospital has its own stroke survivor group, which helps stroke survivors cope with their post-treatment phase, and aims at avoiding further recurrences of the same. Due to increased stress levels and sedentary lifestyles, strokes have been on the rise. We hope to reach out to all the citizens of the city, especially the younger generations through this exhibition in order to take active steps in avoiding new diagnoses of this ailment. It is our consistent approach to increase awareness on issues faced by our communities so that we can effectively manage this calamity.”     ]]> <![CDATA[US give nod to Biocon-Mylan's biosimilar of cancer drug Herceptin]]> https://biospectrumindia.com/news/95/9953/us-give-nod-to-biocon-mylans-biosimilar-of-cancer-drug-herceptin.html https://biospectrumindia.com/news/95/9953/us-give-nod-to-biocon-mylans-biosimilar-of-cancer-drug-herceptin.html Mon, 04 Dec 2017 16:15:00 +0530 The FDA said Mylan's drug Ogivri, which was co-developed with Biocon, was the first biosimilar approved in the United States to treat breast or stomach cancer. Herceptin and other complex medicines called biologics are made from living cells, making them difficult to copy with precision. Their similar versions are called biosimilars, instead of generics.  Ogivri’s permission is based on a review of evidence that included extensive structural and functional characterisation, animal study data, human pharmacokinetic and pharmacodynamic data, clinical immunogenicity data and other clinical safety and effectiveness data that demonstrates its biosimilarity to Herceptin (trastuzumab). Like Herceptin, the labeling for Ogivri (trastuzumab-dkst) contains a Boxed Warning to alert healthcare professionals and patients on increased risks of heart disease, infusions reactions, lung damage and harm to a developing fetus.  "The approval of Ogivri represents a monumental achievement for Mylan to increase patient access to biosimilars and deliver significant savings to the US healthcare system,” said Mylan’s chief executive Heather Bresch.  “It will allow us to bring this important biosimilar – the first of its kind to market in the US, expanding cancer-patient access to more affordable treatment.”  Mylan and Biocon had reached a settlement and licensing agreement with Roche in March to launch the biosimilar in major markets. The terms of the deal and launch dates for the biosimilar in different markets were not disclosed, Mylan said.  Barclay’s analyst Douglas Tsao said “although the drug is not expected to be launched until 2019, the approval adds credibility to Mylan's biosimilar efforts”.  Mylan and Biocon are also developing a biosimilar to Amgen's drug Neulasta, which got a complete response letter (CRL) from the FDA in October, asking for more data related to their manufacturing facilities.  Mylan and Biocon's biosimilar for Herceptin also is under review by regulatory authorities in Australia, Canada, Europe and several additional markets. It is already approved in 19 countries around the world, including India,thus providing increased access to this more affordable biologic for cancer patients. ]]> <![CDATA[Cadila organises Walk-a-thon for AIDS awareness]]> https://biospectrumindia.com/news/95/9945/cadila-organises-walk-a-thon-for-aids-awareness.html https://biospectrumindia.com/news/95/9945/cadila-organises-walk-a-thon-for-aids-awareness.html Fri, 01 Dec 2017 18:10:00 +0530 On the occasion of World AIDS Day, the employees of Cadila Pharmaceuticals Ltd took a 'Step to Stop AIDS' by participating in an AIDS Walk-a-thon organised on Friday, December 1, 2017. The aim of the walk-a-thon was to raise awareness about AIDS and also to open a dialogue for discussion.The walk-a-thon was flagged off at ISKCON and saw the enthusiastic participation of the company's employees. Dressed in blue and white, over 150 employees marched to Prahladnagar raising slogans and banners to throw spotlight on AIDS prevention. Several key messages about this pandemic disease were highlighted as well as archaic, discriminatory myths were busted. Slogans such as "START TALKING, STOP HIV", "SILENCE=DEATH", "Kissing and Hugging doesn't spread HIV" were carried by the participants.Adding further fervour to this walkathon were the members of the Avengers Biker Club of Ahmedabad who had specially escorted the participants throughout their stride.At the end of the walk the participants gathered together in a group and took an oath to remain committed to fight the battle against AIDS by continuing to spread awareness on the disease. ]]> <![CDATA[Himalaya launches herbal medicine for cancer patients]]> https://biospectrumindia.com/news/95/9943/himalaya-launches-herbal-medicine-for-cancer-patients.html https://biospectrumindia.com/news/95/9943/himalaya-launches-herbal-medicine-for-cancer-patients.html Fri, 01 Dec 2017 14:55:00 +0530 Himalaya Drug Company has launched a novel herbal medicine, Oro-T, an advanced mouth rinse with turmeric powder for cancer patients. It is a first-of-its-kind product with preventive and curative properties for Oral Mucositis, which occurs in cancer patients undergoing chemotherapy and radiotherapy.  The product is developed by infusing herbal ingredients like Turmeric, Triphala, and Honey.  Oro-T also helps in treating Oral Submucous Fibrosis (OSF or OSMF), a chronic debilitating disease of the oral cavity characterized by inflammation and progressive fibrosis (hardening) of the underlying tissues of the mouth. OSF or OSMF is mainly associated with chronic Pan and Ghutka users. The clinical trials conducted for Oro-T at a few prominent hospitals have adjudged its effectiveness, attesting that the product is free from any kind of side effects on the body. The product is proven to improve the quality of life of a cancer patient through PROMs (Patient Reported Outcome Measures), a validated and globally accepted tool to analyze the quality of life. ]]> <![CDATA[Dr. Reddy’s achievement: Got first-cycle NDA approval of Impoyz cream]]> https://biospectrumindia.com/news/95/9939/dr-reddys-achievement-got-first-cycle-nda-approval-of-impoyz-cream.html https://biospectrumindia.com/news/95/9939/dr-reddys-achievement-got-first-cycle-nda-approval-of-impoyz-cream.html Fri, 01 Dec 2017 11:30:00 +0530 Dr. Reddy’s Laboratories Ltd., through its wholly owned subsidiary Promius Pharma, LLC, today announced its fifth consecutive, first-cycle NDA approval for the Proprietary Products Group, a substantial milestone within the pharmaceutical industry.  Impoyz (clobetasol propionate) Cream, 0.025% is a high potency topical steroid approved for the treatment of moderate to severe plaque psoriasis in patients 18 years of age or older. The most common side effect of IMPOYZ Cream includes discoloration of the treated site. Psoriasis is a serious medical condition affecting approximately 7.5 million people in the United States. Impoyz, formerly referred to as DFD-06, had been recently licensed to Encore Dermatology Inc. for the commercialization of the product in the United States. This approval is another example of the deep and broad capabilities within the Proprietary Products business unit at Dr. Reddy’s. The organization has achieved several milestones within drug, device, and formulation research and development for novel therapies.  “The fifth consecutive first cycle NDA approval represents Dr. Reddy’s long-term commitment to building an organization that delivers innovative medical solutions,” said Anil Namboodiripad, Senior Vice President, Proprietary Products and President, Promius Pharma. “We are looking forward to working with our partner, Encore Dermatology, to bring this novel treatment to providers and their patients.” “Encore is excited about adding another great product to our portfolio and looking forward to the opportunity to commercialize a new product for the treatment of mild to moderate psoriasis as well as broadening our portfolio outside of atopic dermatitis and acne,” said Robert Moccia, CEO, Encore Dermatology, Inc. ]]> <![CDATA[CEO round table at Indian Pharma Week]]> https://biospectrumindia.com/news/95/9937/ceo-round-table-at-indian-pharma-week.html https://biospectrumindia.com/news/95/9937/ceo-round-table-at-indian-pharma-week.html Thu, 30 Nov 2017 19:25:00 +0530   India’s pharmaceutical leaders deliberated vital issues like efforts for quality compliance, make in India in pharma sector, affordable health care and Indian pharma’s supremacy at the CEO Round Table organised as a part of second edition of Indian pharma week organised by UBM in Mumbai. Most influential CEOs, Presidents & Founders from leading pharmaceutical companies, Policy Makers and Senior Representatives from Pharmaceutical Associations participated in the close door round table. On the quality compliance issue, the industry leaders were of the opinion that approach towards quality compliance should be a behavioural priority with a bottom up direction. A distinction should be made between adherence and compliance and the focus should be on the former when it comes to ground level implementation. In this regards, the leaders opined that more collaboration between academia and the industry was required. An intrinsic link between the industry, government and educational institutions is also highly recommended, they felt. After the round table, the media was briefed about the deliberations jointly by Mr. Sriram Shrinivasan, Partner, EY; Mr. Kewal Handa, Director, Salus Lifesciences; Dinesh Dua, CEO & Director, Nectar Lifesciences; D G Shah, Secretary General, Indian Pharmaceutical Alliance, S M Mudda, Director Global Strategy, Microlabs and Yogesh Mudras, Managing Director, UBM India. Speaking to the media, Mudda said there was need to create quality management system. Shah said culture and behaviour are linked and they need to be nurtured. He said companies were becoming conscious on quality issue. Unless there were some failures they would not improve so it was good to have some failures in the initial phase. On government industry relationship, Handa said industry should have mind set to align with government. He said SME was a priority of r the government. Funds were available for the MSE sector on the projct should be viable and there should be integrity of management. Responding to a question on pricing issue, Dua said government was looking at manufacturing cost, but what about the distribution cost. Sriram pointed out that there were 8 to 10 different methods to control prices. Mudras said, while India ranks amongst the top four pharmaceutical markets in terms of volume of produced drugs, certain challenges continue to surround its pharma industry. India faces issues including a time-consuming approval process, dependence on China for cheaper API sources, sub-optimal infrastructure, lack of funding avenues, and a shortage of highly skilled talent, among others. Those who participated in the round table included S V Veeramani, Chairman & MD, Fourrts (India) Laboratories Pvt Ltd; Prashant Nagre, CEO, Fermenta Biotach; Ranga Iyer, Former MD, Wyeth; Rajiv Gulati, Former President, Ranbaxy; Suresh Subramanium, Senior VP & Head, Branded Formulations, South Asia; Ashok Bhattacharya, Executive Director/ Country Manager, Takeda Pharmaceuticals India Pvt Ltd; Prof. Pierre Pienaar, President, WPO; Dev Prakash Yadava, Managing Director , Shardachem; Dr. G.M. Warke, Founder & CMD HiMedia Laboratories;  A. Vaidheesh, MD, GSK; Ziva Abraham, CEO, Microrite Inc;  Srinivas Lanka, Vice Chairman Pharma and Bio Taskforce, Andhra Pradesh Economic Development Board; B.G. Barve, Joint Managing Director, Bluecross Laboratories Pvt Ltd. ]]> <![CDATA[WHO approves Q-TIB drug by Cipla]]> https://biospectrumindia.com/news/95/9936/who-approves-q-tib-drug-by-cipla.html https://biospectrumindia.com/news/95/9936/who-approves-q-tib-drug-by-cipla.html Thu, 30 Nov 2017 16:50:00 +0530 Cipla has received an approval from the World Health Organisation (WHO) for Q-TIB, a combination drug indicated to help prevent tuberculosis infection in people living with HIV. The company will be marketing the product globally. As per WHO’s Global TB Report, 2016, about one million people died of AIDS-related illness. Most of them succumbed to infections, and among them, 4 lakh died of tuberculosis. Q-TIB is a novel fixed dose combination in a single tablet and it is for the first time that such a combination has been made available in the world. Q-TIB will help prevent tuberculosis infection in people living with HIV as they face a challenged immune system and are prone to infections, which constitute the major source of premature deaths among them. ]]> <![CDATA[Zydus Cadila gets USFDA nod for blood pressure treatment drug]]> https://biospectrumindia.com/news/95/9934/zydus-cadila-gets-usfda-nod-for-blood-pressure-treatment-drug.html https://biospectrumindia.com/news/95/9934/zydus-cadila-gets-usfda-nod-for-blood-pressure-treatment-drug.html Thu, 30 Nov 2017 15:55:00 +0530 Cadila Healthcare said group firm Zydus Cadila has received final approval from the US health regulator to market Candesartan Cilexetil and Hydrochlorothiazide tablets formulations used in treating high blood pressure. The approval by the US Food and Drug Administration (USFDA) is for multiple Candesartan Cilexetil and hydrochlorothiazide tablets of 16 mg/12.5 mg, 32 mg/12.5 mg and 32 mg/25 mg, Cadila Healthcare said in a BSE filing. The drug is used to treat high blood pressure. Lowering blood pressure helps prevent strokes, heart attacks and kidney problems, it added. “It will be manufactured at the group’s formulations manufacturing facility at Moraiya, Ahmedabad,” the filing said. The group has now more than 175 approvals and has so far filed 310 ANDAs since the commencement of filing process in FY2003-04, it said. ]]> <![CDATA[Piramal Enterprises acquires Digeplex and associated brands for its consumer products business]]> https://biospectrumindia.com/news/95/9930/piramal-enterprises-acquires-digeplex-and-associated-brands-for-its-consumer-products-business.html https://biospectrumindia.com/news/95/9930/piramal-enterprises-acquires-digeplex-and-associated-brands-for-its-consumer-products-business.html Thu, 30 Nov 2017 15:10:00 +0530 Piramal Enterprises’ Consumer Products Division announces the acquisition of Digeplex and associated brands from Shreya Lifesciences. Piramal Enterprises Limited is an Indian multi-national business conglomerate expands its Gastro-Intestinal Product Portfolio with this acquisition. It is complementary to its existing brands - Polycrol and Naturolax, in the GI segment and these brands hold rich legacy amongst consumers across India. Nandini Piramal, Executive Director, Piramal Enterprises said, “Our aim is to be a significant player in every business under the Healthcare vertical of Piramal Enterprises Limited. Acquisition is one of the important routes to help us achieve our goal and in the last 2 years, we have completed three acquisitions in the Consumer Products business, itself. According to her, the company  believe Digeplex and its associated brands are a strategic fit for their product portfolio that will help them to move closer towards their stated objective. The combination of organically growing their existing core brands and strategically acquiring accretive brands has helped them create a powerful portfolio of OTC brands in India.  Kedar Rajadnye, COO - Consumer Products Division, Piramal Enterprises said, “Today’s consumers lead a fast and hectic lifestyle, which coupled with stress and infrequent food habits, tends to take a toll on their digestive wellbeing. As per AIOCD October 2017 data, the Gastro Intestinal market in India, which addresses the constipation, diarrhea and appetite stimulant categories, is almost INR 13,000 Crore market and has grown at around 11% yearly.  “We already have a well-established antacid brand – Polycrol, and Naturolax, an Isabgol husk based brand which helps in treating constipation. With these additions, our basket of offerings in the Gastro Intestinal market will become larger. We expect these brands to leverage the strong sales and distribution capability that we have built over the years and help us improve our profit margins. This brand has a huge potential to become a power brand in its category.” He believed and said ]]> <![CDATA[Mitra Biotech Partners with Gotect Diagnostic in Israel]]> https://biospectrumindia.com/news/95/9928/mitra-biotech-partners-with-gotect-diagnostic-in-israel.html https://biospectrumindia.com/news/95/9928/mitra-biotech-partners-with-gotect-diagnostic-in-israel.html Thu, 30 Nov 2017 13:15:00 +0530 Biotech company Mitra Biotech has recently announced an agreement with Gotect Diagnostic for the exclusive right to represent Mitra in Israel. Mitra is headquartered in Greater Boston and maintains a significant research and laboratory presence in Bengaluru, India Mitra's CANscript™ platform recreates a patient's own tumor microenvironment in vitro, measures multiple parameters to determine whether a tumor is responding to physician-selected treatments, and then converts these parameters into a single score that predicts clinical response to each of the physician-selected therapies. CANscript delivers powerful, individualized treatment response predictions. The company has been validated using thousands of cancer cases, with a published 90% overall correlation1 between the platform's treatment predictions and actual clinical outcomes. Gotect is based in Tel Aviv, and supports technological and scientific innovation in the pursuit of improving patient health in Israelas well as other Mediterranean markets. Mallik Sundaram, Mitra CEO and Co-Founder said, "We're proud and pleased to have secured a quality partner like Gotect to introduce CANscript into Israel. Together we look forward to helping inform the selection of effective treatments for Israeli cancer patients." ]]> <![CDATA[Mylan launches biosimilar Bevacizumab, ABEVMY, in India]]> https://biospectrumindia.com/news/95/9927/mylan-launches-biosimilar-bevacizumab-abevmy-in-india.html https://biospectrumindia.com/news/95/9927/mylan-launches-biosimilar-bevacizumab-abevmy-in-india.html Thu, 30 Nov 2017 10:25:00 +0530 Mylan Pharmaceuticals Private Limited today announced the launch of ABEVMY (Injection Bevacizumab 100 mg and 400 mg), an anti-angiogenic drug approved by the Drug Controller General of India (DCGI). It is approved for all indications of the Roche’s Avastin, including for the treatment of metastatic colorectal, non-small-cell lung carcinoma, glioblastoma, ovarian, cervical and renal cancer as part of specific regimens for Indian patients.  The approval of ABEVMY was supported by a comprehensive data package to prove biosimilarity including robust analytical, pharmacokinetic, and pharmacodynamic studies and an India-specific, randomized, double-blind clinical trial in metastatic colorectal cancer patients.  ABEVMY is a recombinant improved monoclonal antibody that selectively binds to human vascular endothelial growth factor (VEGF) and neutralizes its biologic activity. Bevacizumab inhibits the formation of tumor vasculature, thereby inhibiting tumor growth. An important benefit for patients is its price for each therapy cycle, which is comparatively lower than the existing options.  Mentioning on the launch, Mr. Rakesh Bamzai, President, India and Emerging Markets said, “Advancements in research and development have made it possible to deliver better therapy outcomes that improve the quality of patient lives and expand access to treatment options. ABEVMY is the second biosimilar that Mylan has launched to help improve affordability and access to essential oncology treatments in India. We’re proud to bring this product to market and remain deeply committed to serving this patient community through the introduction of biosimilars.”  According to data from the Indian Council of Medical Research, 1.45 million new cases of cancer in the country were reported in 2016. This figure is estimated to increase by approximately 1.73 million new cases annually by 2020.  Mylan’s oncology portfolio in India includes cytotoxic and targeted oncology therapies for common types of cancer. ]]> <![CDATA[Jubilant Biosys announces successful achievement of collaborative discovery programs]]> https://biospectrumindia.com/news/95/9926/jubilant-biosys-announces-successful-achievement-of-collaborative-discovery-programs.html https://biospectrumindia.com/news/95/9926/jubilant-biosys-announces-successful-achievement-of-collaborative-discovery-programs.html Wed, 29 Nov 2017 18:20:00 +0530 Aiming to the discovery and development of small molecule inhibitors for multiple targets intended to achieve the medical needs in diabetes and obesity, union was done in 2016 as a part of a portfolio of programs. From the beginning of this collaboration, the teams of Jubilant Biosys and Sanofi have worked closely on several first-in-class metabolic disease programs. Jubilant Biosys confirmed receiving payment for the first milestone achievement for this collaboration. Jubilant Biosys will continue to apply its effective integrated drug discovery platform to generate novel molecules that can demonstrate clinical proof of mechanism. "Jubilant Biosys has invested in its metabolic disease platform to enable the discovery and development of small molecule therapeutics. We look forward to advancing these programs further through the discovery and development process to deliver important new therapeutics to treat diabetes," said Mr. Steven Hutchins, Jubilant Biosys, President, Drug Discovery Solutions. Dr. Philip, Global Head of Diabetes Research & Chief Scientific Officer, Sanofi, Germany, said: "Sanofi works on continuously innovating to deliver value for people living with metabolic disorders. This productive collaboration with Jubilant Biosys further illustrates our commitment to discover and develop new therapies to support patients with diabetes or its complications." ]]> <![CDATA[Women in Pharma : Aspire, Lead, Inspire]]> https://biospectrumindia.com/news/95/9923/women-in-pharma-aspire-lead-inspire.html https://biospectrumindia.com/news/95/9923/women-in-pharma-aspire-lead-inspire.html Wed, 29 Nov 2017 15:55:00 +0530 The 2nd edition of the celebrated India Pharma Week, a UBM India initiative -- introduced last year to celebrate a decade of CPhI & P-MEC, UBM’s flagship engagement platform, and the world’s leading Pharmaceutical networking event -- witnessed one of its most inspiring and scintillating initiatives, ‘Women in Pharma : Aspire, Lead, Inspire’. The event saw a congregation of some of the most sought-after women leaders in senior-management levels, entrepreneurs, and mentors from the pharmaceutical and bio-pharmaceutical industry to celebrate the significant contribution of women in this industry and share their inspiring stories, experiences and knowledge. Encouraged by the overwhelming response it got last year, the 2nd edition of ‘Women in Pharma’ came with a broader, all-encompassing agenda that also included deliberating discussions by involving senior male leaders from the industry as well. With several global studies pointing to the fact that gender diversity promotes stability and sustainability of the business achieving long-terms goals for the organization. Hence organizations are increasingly channelizing their efforts towards building a gender rich workforce, with a special focus on women in leadership roles. According to Grant Thornton’s global survey report on Women in Businesses 2017, India is the third lowest country in having women in leadership roles. The survey conducted includes 5,500 businesses in 36 economies across the globe also says that 41% of the Indian businesses have no women in leadership roles. The percentage of women executive directors in the pharmaceutical industry is only 7.69%. However, with the latest SEBI guidelines on board representation along with an increasing number of women inspired to make a difference, these figures are slowly changing. Marina Wyatt, CFO, UBM plc, observed: “The issue of gender sensitisation and diversity at the workplace is no longer about 'why', but about 'how' -- how we get the systems and structure in place to drive the same. Similarly, it’s not as much about work-life balance nowadays in the digital world, as much as it is about work-life blend and the opportunity to do so -- where one can seamlessly transition from one to the other, where the personal and professional may merge and enhance the other. We've had similar platforms in other parts of the world such as Women in Engineering, Women in Cruise, Women in Technology etc. She added, “What we are noticing is this 'pipeline' where at the entry level, there is not much of a gap, but gradually, as the seniority level increases, so does the gender gap. At UBM plc, we are getting more proactive on the gender issue from the grass-root level and some of the key themes we are focusing on is 'recruitment', 'development' and 'compensation' and, linking it to the concerned teams' KPIs. Some of the best-in-class professionals of the industry who were a part of the by-invitation only interaction included Sindhushree Khullar, former Chief Executive Officer, NITI Aayog, Former Secretary-Planning Commission, Government of India; Savindu Kudrigikar, Business Head (South Asia), Pharma, Food and Medical, Dow Chemical International Pvt. Ltd.; Aparna Thomas, Senior Director – Communications & CSR (India & South Asia), Sanofi; Deepshikha Mukerji, Regional Human Resources Director, Established Pharmaceuticals, Abbott; Pratima Reddy, Director – R&D Portfolio, Governance and Strategy Merck Consumer Health (CH), Merck; Rajiv Oza, HRBL - Global Manufacturing & Supply (GMS) , South Asia, GlaxoSmithKline Pharmaceuticals Ltd.; Dr. Sofia Mumtaz, President-Portfolio and Legal, Lupin Ltd.; Ameera Shah, Promoter & Managing Director, Metropolis Healthcare Ltd.; and Kanchana TK, Director General, Organisation of Pharmaceutical Producers of India along with an inspirational talk by Vasu Primlani, Corporate trainer and stand-up comedian. Speaking on the occasion of ‘Women in Pharma: Aspire, Lead, Inspire’, Mr. Yogesh Mudras, Managing Director, UBM India said, “Diversity and inclusion, especially gender diversity is a granted principle in the workplace today, but unfortunately still not well-executed. One of the major reason why ‘Women in Pharma conference’ is an integral part of India Pharma Week is to address and raise the key issues of lower women leaders in the pharma sector. Given the upsurge in the pharmaceutical sector in India with over 25,000 companies, there is a tremendous potential for jobs for women in leadership positions and otherwise. However, according to the Skill India Report, while the industry-wise hiring targets for women in pharma and healthcare sectors currently is about 38.67 per cent, the total employability of women is only about 28.28 per cent.” He added, "In spite of the obvious benefits, most sectors are failing to hire, retain and promote qualified women. What would make a vital difference then would be to spread awareness, education and a can-do attitude. It is for women leaders – and their male counterparts – to share their experiences as well as encourage and inspire other women to take the lead and a platform like Women in Pharma provides just that.”  ]]> <![CDATA[Azafran Innovacion introduces new SPF Crème]]> https://biospectrumindia.com/news/95/9909/azafran-innovacion-introduces-new-spf-crme.html https://biospectrumindia.com/news/95/9909/azafran-innovacion-introduces-new-spf-crme.html Tue, 28 Nov 2017 15:40:00 +0530 Azafran Innovacion Ltd has launched D’Fend SPF Crème, SPF 30 and SPF 50. The new D’Fend SPF Crème by Azafran is a sun warrior. It is a daily use sunscreen made with natural ingredients like Mineral rich water and Organic Soya Butter. It can be used for face and body and gives high broad-spectrum sun protection against harmful UVB and UVA rays. It protects the skin from seasonal pollution, reduces pigmentation, sun burn and sun tan.  Apart from this, mineral rich water in the crème hydrates the skin, while organic soya butter moisturizes, soothes wrinkles and nourishes the skin. So, by adopting this crème in their regular skin care routine, one can get moisturization and sun protection in a single step. There are two variants of the crème- SPF 30 and SPF 50. While SPF 30 can be used for indoors, SPF 50 gives very high sun protection for those who are engaged in any outdoor and sports activities. Sweat and water-resistant formula makes it ideal for those involved in activities like swimming. Both the sunscreens have UVA protection which blocks more than 90% of the sun rays. It is suitable for all skin types and can also be applied on babies 2 years and above. As the crème is made with natural ingredients, it does not block the skin pores, so will not cause acne and breakouts. Its light weight texture gets absorbed into the skin within seconds without making the skin white. It can be ordered online through Azafran’s own website (azafranorganics.com) and amazon.in. It is also available at selected general trade and modern trade stores. Skin needs protection from sun induced skin damage throughout the year and Azafran’s sunscreens are ideal to be used all year round. ]]> <![CDATA[MSD announces major investment in the UK]]> https://biospectrumindia.com/news/95/9899/msd-announces-major-investment-in-the-uk.html https://biospectrumindia.com/news/95/9899/msd-announces-major-investment-in-the-uk.html Mon, 27 Nov 2017 17:10:00 +0530 The investment announced by MSD, known as Merck and co. in North America, will support a new life sciences discovery research facility in the UK, supporting a total of 950 jobs in highly skilled research roles. The news comes as the government is set to unveil its industrial strategy, with a long-term plan for how Britain can build on its economic strengths and embrace technological change. Business secretary Greg Clark said: “We are at one of the most important, exciting and challenging times there has ever been in the history of the world’s commerce and industry. “Powered by new technology, new industries are being created, existing ones changing and the way we live our lives – as workers, citizens and consumers – transformed. “In this Industrial Strategy we set out how we will maintain and enhance these and other strengths and deploy them to our advantage.” Investments by pharmaceutical companies into the UK will form a key part of the sector deal, a central industrial strategy measure, set to be signed in the coming weeks by the life sciences sector and government. Announcing the investment, business secretary Greg Clark said: “Our life sciences sector is one of the UK’s fastest developing industries, with a turnover in excess of £64bn, employing 233,000 across the UK. “MSD’s commitment today, and the wider sector deal investment we have secured, proves the process outlined in the Industrial Strategy can give companies the confidence and direction they need to invest in the UK. It will ensure Britain continues to be at the forefront of innovation and represents a huge vote of confidence in our Industrial Strategy.” Health secretary Jeremy Hunt said: “I want patients to continue to be at the front of the queue for the best treatments available. The NHS has a proud history of spearheading medical innovation and today’s investment in our strong and growing life sciences sector will see patients in the UK continue to benefit from world-leading research and pioneering medicines.” MSD managing director in the UK and Ireland, Louise Houson said: “We believe the UK to be a unique bioscience centre of excellence and this investment presents a major opportunity for us to work in collaboration with the UK government to build on the forward thinking and ambitious Industrial Strategy white paper being published by the governmen.” ]]> <![CDATA[Glenmark’s Kwitz: A substitute for tobacco]]> https://biospectrumindia.com/news/95/9900/glenmarks-kwitz-a-substitute-for-tobacco.html https://biospectrumindia.com/news/95/9900/glenmarks-kwitz-a-substitute-for-tobacco.html Mon, 27 Nov 2017 17:05:00 +0530 Kwitz® is a Nicotine Replacement Therapy (NRT) that helps to slow down the desire of smoking over three months. In India, approximately 2,200 people die every day from tobacco-related diseases, and World Health Organization (WHO) predicts that the death toll will cross 1.5 million annually by 2020. Glenmark Pharmaceuticals Limited announced the launch of Kwitz®, a medically approved nicotine replacement therapy that helps smokers to achieve the smoke free life step by step. Kwitz® Nicotine gum will be available in two variants. Kwitz® 2mg will be available as an OTC product for smokers having less than 20 cigarettes per day and Kwitz® 4mg for smokers consuming more than 20 cigarettes per day as prescription product. Kwitz®, a Nicotine Replacement Therapy (NRT) product, provides treatment to smokers who are willing to get on a journey to quit smoking altogether by reducing dependency on cigarettes gradually. NRTs substitute a small quantity of nicotine otherwise obtained from cigarette smoking, with clean nicotine in moderate amounts to help satiate the cravings, thereby assisting an individual in controlling the withdrawal symptoms and reduce chances of a relapse. Unlike tobacco smoke, it allows users to access nicotine, which is free from harmful chemicals like carbon monoxide, tar and other irritants hence providing a safe way for smokers to achieve a smoke-free life. On the occasion of the launch Sujesh Vasudevan, President, and Head - India, Middle East and Africa, Glenmark Pharmaceuticals Ltd, said, "Glenmark is proud to bring Kwitz®, a nicotine replacement therapy in India. This product will help smokers to achieve a healthier life by quitting tobacco smoking. We hope that Kwitz® will help individuals find a sustainable way to stop smoking in an easy step by step process." He further added, "Kwitz® is not just a product but a helping hand and support system for those who would want to quit smoking completely, thereby helping the individual and those who are around them." ]]> <![CDATA[Portea pumps $26 million funding in its Series C round from Sabre Partners, others]]> https://biospectrumindia.com/news/95/9898/portea-pumps-26-million-funding-in-its-series-c-round-from-sabre-partners-others.html https://biospectrumindia.com/news/95/9898/portea-pumps-26-million-funding-in-its-series-c-round-from-sabre-partners-others.html Mon, 27 Nov 2017 16:45:00 +0530 Consumer healthcare solutions provider Portea Medical, owned by HealthVista India Pvt. Ltd, has raised US $26 million in a Series C funding round led by Sabre Partners and Manipal Group’s MEMG CDC fund. Portea’s existing investors Accel Partners, International Finance Corporation and Qualcomm Ventures also participated in this round. “With this funding round, we will add more depth to our services and consolidate our position as a trusted port-of-call for every healthcare need that an individual and his/her family members may have outside of hospital care,” said Meena Ganesh, chief executive officer (CEO) of Portea. Portea provides four broad healthcare services on its online platform—primary care, chronic disease management, elder care and post-operative care. Services offered include physiotherapy, doctor consultations, specialty pharmacy, wellness and diabetic care. The start-up works with more than 50 hospitals and 15 pharmaceutical and insurance companies in India for offering its services online.  Portea raised US $37.5 million in a Series B funding round led by Accel and International Finance Corp in September 2015. The company was founded in 2012 by Zachary Jones and Karan Aneja. It was then acquired by serial entrepreneurs Krishnan Ganesh and his wife Meena Ganesh in 2013 for an undisclosed amount, in an all-equity deal. “Portea has built a comprehensive, tightly integrated platform for a range of tech-led healthcare services. In less than five years, we have served more than 2.5 lakh customers across 16 cities in India and created hundreds of jobs. We look forward to further refining the paradigm for consumer-centric healthcare in India with the continued support of our customers, investors and healthcare industry partners,” Ganesh said in a statement. “Our investment in Portea will help the company scale and embed technology to improve efficiency and effectiveness in its delivery. Considering that (online) home care service will be delivered significantly through people, this will directly lead to employment generation (the company will engage close to 6000 people in two years’ time) and skill upgradation for its (Portea’s) personnel,” said Harinarayan Sharma, managing director (MD), MEMG CDC Ventures in a statement. Till date the company has raised more than US $70 million in funding and acquired two companies to expand its offerings in the home healthcare segment. In March 2016, it acquired Health Mantra to expand into specialty care segments like respiratory care, geriatric care and orthopedics. In November 2015, Portea acquired Medybiz Pharma Pvt. Ltd, a pharmaceutical distributor for an undisclosed amount. Portea competes with other online healthcare providers like Practo, Lybrate, and 1mg which offers online ordering of medicines. Practo had acquired its smaller rival Qikwell in 2015. Practo had also raised US $55 million from China’s Tencent and others in January. ]]> <![CDATA[Cadila Pharma receives Healthcare leadership award]]> https://biospectrumindia.com/news/95/9895/cadila-pharma-receives-healthcare-leadership-award.html https://biospectrumindia.com/news/95/9895/cadila-pharma-receives-healthcare-leadership-award.html Mon, 27 Nov 2017 15:30:00 +0530 Cadila Pharmaceuticals Ltd. has won the prestigious Healthcare Leadership Award instituted by World Health Congress. The company won the award in the HR category for Excellence in Training and Development. The award is in recognition of Cadila Pharmaceuticals’ outstanding initiatives in contribution towards Government of India‘s ‘Skill India’ mission. Dr. Sudendra Rao, Global Head of HR and Mr. Nilesh Deshmukh, Sr. GM HR received the award from Mr. Nurul Islam Nahid, Hon'ble Education Minister, Bangladesh at a grand event held recently at Taj Lands End, Mumbai. Commenting on the achievement, Dr. Rajiv Modi, Chairman and Managing Director, Cadila Pharmaceuticals Ltd. said, “Cadila Pharmaceuticals has pioneered in building a quality culture by developing our employees through continuous training and development programs as well as nurturing fresh talent for making them industry ready”.  Cadila Pharmaceuticals has made sizeable investments in infrastructure, equipment, campus, competent trainers and mentors. Cadila Pharma has also set up a Life Science Finishing School at its pioneer educational institute - Indrashil Institute of Science and Technology (IIST), Kadi.  In addition, Cadila Pharmaceuticals has a dedicated training centre known as “Centre for Professional Excellence (CPEX)” for developing its field staff. This is the first training center accredited in Gujarat by Life Science Sector Skill Development Council (LSSSDC) and has emerged as an Academy of Excellence, augmenting a pool of quality Trainers and Assessors. ]]> <![CDATA[Sun Pharma recalls Riomet due to contamination]]> https://biospectrumindia.com/news/95/9891/sun-pharma-recalls-riomet-due-to-contamination.html https://biospectrumindia.com/news/95/9891/sun-pharma-recalls-riomet-due-to-contamination.html Mon, 27 Nov 2017 11:05:00 +0530 Sun Pharma has voluntarily recalled two lots of its diabetes drug 'Riomet' due to microbial contamination. According to reports by the US Food and Drug Administration (US FDA), this is one of the several voluntary recalls that the firm has carried out this year for different products. The Indian drug major has decided to recall the lots of Riomet to the retail level as part of a 'Class II' recall after it was found they were contaminated with Scopulariopsis brevicaulis, a microfungus. According to US FDA, a Class II recall occurs in a situation where use of or exposure to the product may lead to temporary or medically reversible adverse health consequences. The microbial contamination was discovered during sample preparation for the 'Antimicrobial Preservative Effectiveness Testing' (AMPET) being performed as part of the drug's 12-month stability study interval. Riomet is indicated to treat type-2 diabetes mellitus in adults and children over 10 years old. The company has stated that the use of Riomet potentially could result in a risk of infection, especially in immuno-compromised patients.   ]]> <![CDATA[Pharma Park- quality drug at low cost ]]> https://biospectrumindia.com/news/95/9884/pharma-park-quality-drug-at-low-cost-.html https://biospectrumindia.com/news/95/9884/pharma-park-quality-drug-at-low-cost-.html Fri, 24 Nov 2017 15:15:00 +0530 In order to ensure quality drugs at affordable cost, a Pharma Park, which can manufacture at least a part of the medicines currently being purchased by the state from private players, is being planned. A medical device park also is in the pipeline. The medicinal drug market in Kerala constitutes around 10% of the total sales in India whopping Rs 6,000-8,000 crore every year and many pharmaceutical companies, mostly multinationals, take advantage of the situation and charge exorbitant rates. The Kerala Drugs and Pharmaceuticals Limited can meet orders to the tune of Rs. 40 crore annually. So, government intervention is needed to bring down the prices of drugs, says the new health policy. The production capacity of Kerala State Drugs and Pharmaceuticals Limited (KSDP) can be augmented to manufacture medicines worth around Rs 100 crores. The Pharma Park should be able to manufacture at least Rs. 1,000 crore worth of drugs within 5-10 years. The drugs produced here, branded as Kerala Generic, will be made available both in the government hospitals and the open market. "We are purchasing drugs at 30 to 40% discount and this could be done through negotiation process. Actual price of many of the drugs, especially cancer medicines, are very low," said Dr Paul Sebastian, director, Regional Cancer Centre (RCC), Thiruvananthapuram. "Once more drugs are produced in the public sector, it would help decrease the price considerably," he added. Patented drugs, mostly those for cancer management are sold at exorbitant prices. To ensure that medicines are affordable and accessible to common man, the state government should make use of the provisions of Indian Patent Act, 1970, states the policy. There is vast scope for producing high quality ayurveda, siddha and unani drugs in the state. "Government has used the provisions in the Patent Act on earlier occasions as well. Kerala government, a few years ago had given compulsory licence to a few manufacturing companies to produce two or three types of medicines to ensure quality drugs at affordable prices," Paul Sebastian said. ]]> <![CDATA[Biocon launches KRABEVA to treat cancer ]]> https://biospectrumindia.com/news/95/9877/biocon-launches-krabeva-to-treat-cancer-.html https://biospectrumindia.com/news/95/9877/biocon-launches-krabeva-to-treat-cancer-.html Thu, 23 Nov 2017 16:15:00 +0530 Biocon Ltd, Asia's premier biopharmaceuticals company, has launched KRABEVA, a biosimilar Bevacizumab for the treatment of patients with metastatic colorectal cancer and other types of lung, kidney, cervical, ovarian and brain cancers, in India. KRABEVA, a monoclonal antibody (mAb) developed by Biocon, will help expand access to a world class, high quality biosimilar Bevacizumab for cancer patients in India. It is the world’s first and only Bevacizumab with a unique ‘Qual-Check’ mechanism, which will ensure that patients get a quality-ascertained product right up to infusion.  Bevacizumab is indicated as a first-line treatment of patients with metastatic colorectal cancer (mCRC).It is accepted as a standard treatment option in combination with chemotherapy for patients with non-small-cell lung cancer (NSLC), metastatic renal cell carcinoma and recurrent ovarian cancer. Dr Arun Chandavarkar, CEO & Joint Managing Director, Biocon said: “With KRABEVA we intend to provide a high quality, world-class biosimilar Bevacizumab as an affordable therapy option for patients of various types of cancer. We believe KRABEVA will be an important addition to our Oncology portfolio of novel biologics as well as biosimilars, which are making a significant impact in the realm of cancer care in India.” KRABEVA is the second key oncologic biosimilar product from Biocon’s global biosimilars portfolio to be launched in India, in order to address the unmet patient need for affordable biological therapies. It is being offered to patients at an MRP of Rs 24,000 for 100 mg / 4 ml vials and Rs 39,990 for 400 mg / 16 ml vials, making it a high quality affordable alternative to the innovator brand. KRABEVA is being launched post successful completion of Phase III clinical trials and approval of Biocon’s Marketing Authorization Application by the Drug Controller General of India (DCGI). Most biologic products require a specific storage condition to maintain the safety, purity and potency of the drug. An efficient and seamless cold chain prevents denaturation of antibodies due to heat. KRABEVA is being introduced with an innovative temperature-sensitive packaging that includes thermo-chromic stickers, which change colour irreversibly if the cold chain temperature is not maintained. This first-of-its-kind ‘Qual Check’ feature ensures quality check of the product up to the point of administration to the patient. This will provide greater confidence to pharmacists, nurses and caregivers about the quality of the product they are dispensing and will enable better patient safety.   Biocon’s biosimilar Bevacizumab has been developed for global markets with a clear focus to meet strict quality and regulatory requirements and provide access to a high quality biosimilar to patients. The Phase III clinical study involving 146 patients of mCRC, has been conducted after obtaining regulatory approvals in India. The extrapolation to other indications has been approved by the DCGI.  The global Phase III trial in non-small-cell lung cancer (NSLC) patients is being conducted at more than 100 sites across multiple countries using an EU and US sourced reference product. Prior to this, a three-way Phase I PK study in healthy volunteers was conducted in Europe.  Bevacizumab is a monoclonal antibody (mAb) targeting Vascular Endothelial Growth Factor- A (VEGF-A), a   cell protein that induces growth of blood vessels that feed tumors.  By blocking this protein, Bevacizumab cuts the supply of food and oxygen to the tumor, thus starving it.  Bevacizumab is prescribed in the treatment of several cancers including metastatic colorectal cancer, ovarian cancer, advanced non-small-cell lung cancer, recurrent glioblastoma, cervical cancer and renal cancer.  The launch of KRABEVA, biosimilar Bevacizumab, comes at a time when the incidence of cancer is projected to reach alarming numbers, with over 17.3 lakh new cases of cancer and over 8.8 lakh cancer deaths projected in India by 2020 as per the Indian Council of Medical Research (ICMR).  An estimated 64,000 cases of colorectal cancer were diagnosed and 49,000 deaths recorded due to the disease in India, according to GLOBOCAN’s 2012 estimates of the worldwide incidence and mortality from cancers. There were an estimated 1.14 lakh new lung cancer cases in India in 2016 and the number is projected to grow to 1.40 lakh by 2020, according to ICMR. Similarly, new cervical cancer cases are expected to rise from an estimated 1 lakh in 2016 to about 1.04 lakh by 2020.  Global sales of the innovator product in 2016 were pegged at USD 6.9 billion. The market size for Bevacizumab, both innovator product and biosimilar, in India is estimated at Rs. 177 Crore (USD 27 million), according to IPSOS June MAT 2017 data.     ]]> <![CDATA[Strand life sciences receives college of American Pathologists (cap) re-accreditation]]> https://biospectrumindia.com/news/95/9873/strand-life-sciences-receives-college-of-american-pathologists-cap-re-accreditation.html https://biospectrumindia.com/news/95/9873/strand-life-sciences-receives-college-of-american-pathologists-cap-re-accreditation.html Thu, 23 Nov 2017 12:30:00 +0530 Bangalore based bioinformatics company Strand Life Sciences has been awarded accreditation by the Accreditation Committee of the College of American Pathologists (CAP) for quality assurance in diagnostics for the Strand Centre for Genomics and Personalized Medicine Lab in Bangalore. The federal government of the United States of America recognizes the CAP Laboratory Accreditation Program to be equal to or more stringent than the government’s own inspection program. The primary goal for the CAP accreditation is patient safety and prevention of medical malpractice. The CAP accreditation process is designed to ensure the highest standards of operations for all laboratory procedures. A CAP-accredited lab’s records and quality control procedures, followed for two years, are checked thoroughly by the inspectors at the time of the inspection. CAP inspectors also examine laboratory staff qualifications, equipment, facilities, safety programs, safety record as well as overall management prior to awarding the accreditation to any organization. Dr. Satish Sankaran, Vice President – Clinical Operations & Laboratory Director – Clinical Lab, Strand Life Sciences said, “In order to maintain the high standards that are expected by CAP, we conduct a voluntary process audit every 6 months to ensure consistent and accurate analyses. It also ensures that we maintain quality control at every step in the workflow and use CAP-validated bioinformatics and analytics protocols to provide diagnostic solutions to all patients. Safety and accuracy are our primary objectives.” Dr. Vijay Chandru, Chairman and Managing Director, Strand Life Sciences said, “Moreover, implementation of CAP guidelines shows reduction of methodological errors by 35% in clinical research settings. The Strand Centre for Genomics and Personalized Medicine received the CAP accreditation in 2015 and the same has been reaffirmed in 2017.”   ]]> <![CDATA[Avantor completes acquisition of VWR]]> https://biospectrumindia.com/news/95/9868/avantor-completes-acquisition-of-vwr.html https://biospectrumindia.com/news/95/9868/avantor-completes-acquisition-of-vwr.html Thu, 23 Nov 2017 09:55:00 +0530 Avantor, Inc. is a global supplier of ultra-high-purity materials for the life sciences and advanced technology industries. Avantor, announced the successful completion of its acquisition of VWR Corporation (NASDAQ: VWR). It is the leading global independent provider of product, supply chain, and service solutions to laboratory and production customers. VWR will operate as a wholly-owned subsidiary of Avantor. Michael Stubblefield, Chief Executive Officer of Avantor, will lead the combined company. The acquisition reflects an enterprise value of approximately $6.5 billion for VWR, with stockholders receiving $33.25 per share in cash.As a result of the closing of the transaction, VWR common stock will cease trading today on the Nasdaq Stock Market. “The completion of this acquisition marks the beginning of an exciting new chapter for our combined organization. The new Avantor is a leading global provider of discovery-to-delivery solutions that offer more value to customers along with an additional layer of supply chain security.” said Mr. Stubblefield. “With enhanced scale and favorable long-term industry dynamics, we are well positioned to accelerate growth, benefiting from deeper access to the high-growth biopharma, industrial, and applied research sectors. Together we have increased reach and direct channel access, customized logistics and product requirements, and a strong local presence in both developed and emerging markets. Just as important, the combined company will create new opportunities for our stakeholders, including our employees, customers and the industries in which we operate.” He added further. Stubblefield continued, “We are pleased with the significant progress that our cross-functional teams have made through the integration planning process. We intend to successfully combine the best attributes of our operational models, harmonize processes and expand our product and service solutions to best serve our customers. These efforts will create a foundation for success well into the future.”  Manuel Brocke-Benz, former Chief Executive Officer of VWR, commented, “By executing on our business plan and growth strategy, VWR built a truly differentiated company, with broad global distribution capabilities and a breadth of essential products, services and technology offerings for laboratory and production customers around the world. I have every confidence that combining VWR with Avantor’s expertise in high-purity materials will enable the new organization to even better meet our global customers’ evolving needs.” New Mountain Capital will be the lead shareholder of the combined company. As part of the transaction, the Goldman Sachs Merchant Banking Division is leading an equity investment in the company.  Matt Holt, Managing Director at New Mountain Capital, said, “The combination of Avantor and VWR creates a vertically integrated global company, optimally positioned to drive growth in dynamic sectors and serve an expanding global customer base. We look forward to our continued partnership with management through its next phase of successful value creation.”  Avantor will be the corporate name of the new company, and the VWR name will remain in place as one of the company’s selling channels. By ensuring a seamless transition for customers and offering the ability to continue ordering from vwr.com. Avantor will maintain a strong presence in both the Lehigh Valley and Radnor, Pennsylvania regions.  Goldman Sachs, Jefferies LLC, Barclays and JP Morgan acted as financial advisors to Avantor, and Simpson Thacher & Bartlett LLP acted as legal advisor to Avantor. BofA Merrill Lynch acted as exclusive financial advisor to VWR, and Kirkland & Ellis LLP acted as legal advisor. ]]> <![CDATA[PULSUS;expanding at Chennai and Gurgaon]]> https://biospectrumindia.com/news/95/9866/pulsusexpanding-at-chennai-and-gurgaon.html https://biospectrumindia.com/news/95/9866/pulsusexpanding-at-chennai-and-gurgaon.html Wed, 22 Nov 2017 13:25:00 +0530 Pulsus focus will be to lead Pharmacovigilance works including collection, archival and monitoring of Individual Case Study Reports, studies in the global market. To increase headcount from 500 to 2000 by 2018  Hyderabad based Serial entrepreneur Dr. Srinubabu has acquired Canada based scientific medical informatics Pulsus Group Inc. The company will foray into big scientific, medical informatics market worldwide for an undisclosed amount.  Dr. Srinubabu also announced PULSUS will expand in India with 2 new centers; Chennai and Gurgaon in next few months and these 2 centers will be an addition to Hyderabad center.  Established in the year 1984, Pulsus initially focused on American region and presently it is expanding to healthcare informatics platform to the medical and pharma professionals throughout Europe, America, Asia, Australia and all other continents.  Since its inception, Pulsus received the endorsements of the medical associations and industries of the international reputation.  "PULSUS is committed to building the domestic scientific and medical Informatics market supported by a team of 500 people with a target to grow the team to 2000 by early next year. This is a 100% acquisition through a combination of cash and equity.” Dr. Srinubabu stated who will spearhead the venture as CEO.  Dr. Srinu commented on release that “In recent years, cities like Chennai and Gurgaon has become increasingly important as a center for science and research, as can be seen in the growing number of universities and companies with R & D departments”.  “PULSUS is young in India; our aim is to become the authentic healthcare informatics source for university libraries, research institutes, students and academics, as well as for corporate R & D departments”. Dr. Srinu said.  Stating about PULSUS activities Dr. Srinu said “In every city we will work with partners in the region to develop publications of worldwide interest and enhance reputation to our high scientific standards.  These offices will be serving all of its clients and potential clients for all related products and services. Our target is to open our center in New Delhi early 2018. ]]> <![CDATA[India Pharma Week to start from Nov 25]]> https://biospectrumindia.com/news/95/9865/india-pharma-week-to-start-from-nov-25.html https://biospectrumindia.com/news/95/9865/india-pharma-week-to-start-from-nov-25.html Wed, 22 Nov 2017 11:55:00 +0530 UBM India, India's leading B2B exhibition organizer, is all set to bring in the second edition of  India Pharma Week, a week-long celebration packed with avant-garde events from 25th to 30th November alongside its flagship expo CPhI and P-MEC India. In its 11th edition, the marquee expo will be held at two venues in Mumbai: MMRDA Grounds, Bandra Kurla Complex (27th to 29th November) and Bombay Exhibition Centre (28th to 30th November).     Celebrating 11 years of CPhI and P-MEC India, the India Pharma Week will organise more than 10 events and activities taking place across the city of Mumbai. In event, 1500+ exhibitors from 40+ countries are participating. It is the South Asia’s largest Pharma event pertaining to the streams of business, knowledge, leadership, innovation, recognition and networking in the field of Pharma.  Speaking on the announcement of the IPW, Mr. Yogesh Mudras, Managing Director, UBM India said, “I am delighted to announce the second edition of the India Pharma Week, an unrivalled offering to the world of exhibitions along with CPhI & P-MEC India, UBM’s flagship engagement platform, and the world’s leading Pharmaceutical networking event. An epitome of India’s strength in the Pharma industry, the expo has consistently grown to serve as an exclusive congregation of key global players across the pharmaceutical sector. Further, the expo would deliberate upon Government of India’s ‘Pharma Vision 2020' to make India a global leader in end-to-end drug manufacturing in boosting investments. “The India Pharma Week stems from the proactive role it plays in driving key Governmental initiatives such as ‘Make in India’, ‘Start-Up India, Stand Up India’, and ‘Skill India’ connecting the global community to eke out solutions to challenges, and establishing superior standards within it. With the recent proposal by the Drug Controller General of India (DCGI) to make it mandatory for all employees in pharmaceutical manufacturing facilities to get skill certification, a notable congregation of industry experts and knowledge sharing, such as IPW provides, becomes even more significant,” he further added. The week will commence with a Plant visit followed by a series of engagements such as Pharma Leaders Golf, Pre-Connect Congress, Women in Pharma, Power Breakfast, India Pharma Awards, Networking Evening, the CPhI & P-MEC India Exhibition, a closed-door CEO Roundtable and many more activities. “CPHI provides global platform for the Indian Pharma industry to know and have the exposure of the latest technology available. In the past, Indian Pharmaceutical decision makers had to travel to international exhibitions to get to know new innovations on the technology front. However CPHI & P-Mec has brought this information to Indian pharma’s doorsteps”, said Mr. Damanjit Singh, CEO, Food & Pharma Specialities. Ms. Saloni Wagh, Marketing & Business Development ,Asia Pacific, Supriya Lifescience also shared her past experiences of the CPhI conference and said, “CPhI is one of the leading Pharma events in the world where the entire Industry comes together to discuss and get updated on the current trends, information and issues”. She further added “CPhI Worldwide exhibitions do play an important role in our marketing strategy as it is a platform for us to meet all our customers from across the globe under one roof. It is also a great platform to launch new products and to identify potential customers”, Incepted in 2006, the CPhI & P-MEC India exhibition has grown remarkably larger over the years with exhibitors and visitors engaging over significant levels of business. It has been approved and comprehensively assisted in its endeavours by governing bodies such as Pharmaceuticals Export Promotion Council (Pharmexcil).  Spread across two locations, this year's edition will see more than 1500 exhibitors and participation from over 40 countries. ]]> <![CDATA[Maha govt, Centre to join hands for developing APIs, device parks at MIHAN, Nagpur]]> https://biospectrumindia.com/news/95/9856/maha-govt-centre-to-join-hands-for-developing-apis-device-parks-at-mihan-nagpur.html https://biospectrumindia.com/news/95/9856/maha-govt-centre-to-join-hands-for-developing-apis-device-parks-at-mihan-nagpur.html Tue, 21 Nov 2017 13:45:00 +0530 Maharashtra Chief Minister Devendra Fadnavis and Union Minister for Road Transport, Highways and Shipping Nitin Gadkari are scheduled to discuss an action plan in Mumbai shortly for developing bulk drugs and medical devices park at Multi-Model International Cargo Hub and Airport at Nagpur (MIHAN) through a collaborative approach. As a part of its policy of ease of doing business, center is planning to develop multi-product Special Economic Zone (SEZ) at MIHAN.Both the ministers are scheduled to discuss modalities and explore areas of investment for setting up common facilities of manufacturing and testing in consultation with pharma industry, according to an official associated with the development. This comes close on the heels of Maharashtra Food and Drug Administration (FDA) holding talks with pharmaceutical companies in Nashik, Aurangabad, Mumbai, Pune and Thane to explore investment opportunities for developing pharma hub at Multi-Model International Cargo Hub and Airport at Nagpur (MIHAN) multi-product Special Economic Zone. According to officials, 1000 acres of land in MIHAN SEZ is likely to be developed for API production, which will boost exports and deemed exports. Meanwhile, a technical feasibility study is also underway for setting up of medical device park at MIHAN which will also be equipped with common facilities for testing and manufacturing competencies on par with Andhra Pradesh Med Tech Zone (AMTZ) at Visakhapatnam in Andhra Pradesh. The MIHAN management is also in the process of earmarking the land, land rate and formulating policies on the same for developing medical device park. Currently, medical device manufacturing by few players have also started at MIHAN. These ongoing developments which are also in the interest of domestic industry is supplemented by the coming up of institutions like All India Institute of Medical Sciences (AIIMS) in an area of 150 acres in the coming years and Indo UK Medicity in an area of 152 acres at MIHAN. This will pave the way for development of pharma and life sciences cluster in the country.  The Indo-UK medicity currently being run in coordination with King’s College London for treating foreign patients is aimed at giving boost to medical tourism which will bring in foreign investments. Setting up of a medical device park at MIHAN, Nagpur has been deliberated comprehensively between MIHAN management team and medical device associations.  Seeing the potential in terms of investment and business prospects, the Maharashtra Airport Development Company Ltd (MADC) is inviting pharmaceutical companies to set up their units in MIHAN project. The project will have a dedicated zone along with certain benefits for the pharmaceutical companies setting up their units in the project. The multi product Special Economic Zone in MIHAN is sought to be developed for both API and formulations. These units will have the benefits of duty free import or domestic procurement of goods for development, operation and maintenance of SEZ units; 100 per cent income tax exemption on export income for SEZ units for the first 5 years, 50 per cent for the next 5 years thereafter and 50 per cent of the ploughed back export profit for the next 5 years; external commercial borrowing (ECB) by SEZ units up to US$ 500 million in a year without any maturity restriction through recognized banking channels; exemption from central sales tax; exemption from service tax; single window clearance for central and state level approvals; exemption from state sales tax and other levies as extended by the state government and 100 per cent FDI is being allowed. ]]> <![CDATA[First made-in-India DIGITAL PILL for diabetes]]> https://biospectrumindia.com/news/95/9857/first-made-in-india-digital-pill-for-diabetes.html https://biospectrumindia.com/news/95/9857/first-made-in-india-digital-pill-for-diabetes.html Tue, 21 Nov 2017 13:10:00 +0530 The WeDiDiT (Wellthy Digital Diabetes Therapy) trial is all set to prove the efficacy of its 16-week structured diabetes management programme delivered through a mobile app. The trial was launched by Past President of RSSDI, Dr. Sarita Bajaj at the RSSDI Annual Conference in Bhubaneswar, in the first week of November. The outcome of this multi-center randomized control trial will be measured by the HbA1C levels of patients before and after the trial.  As part of the programme, personalized diabetes self-management education and real time coaching will be offered through dedicated health coaches and an artificial intelligence powered chat bot, to engage and improve the health of patients with type2 diabetes by facilitating behavior change.  Commenting on the first-of-its-kind initiative in India, Mr. Abhishek Shah, Co-founder and CEO of Wellthy Therapeutics said, “On World Diabetes Day, we re-affirm our commitment to solve for the diabetes epidemic. Conducting a clinical trial on a mobile app is unprecedented in India and we are extremely optimistic about the study outcomes. The Wellthy app has already demonstrated its efficacy in various pilot studies. This formal clinical trial will  show that digital therapeutics have the potential to improve the lives of diabetes patients in India and around the world.”  Dr. Rajeev Chawla, Current President Elect of RSSDI said, “The need for digital interventions in diabetes care is more now than ever, especially in India. The Wellthy Diabetes intervention is an innovation born out of India, for Indians and South Asians. This clinical trial holds tremendous potential in terms of changing outcomes for persons living with diabetes, by making it easier for them to manage their blood sugar levels and improving their overall quality of life.”  Dr. Sarita Bajaj, the Past President of RSSDI added, “Wellthy and RSSDI together are set to launch the first ever landmark trial in South Asia to test the impact of using digital technologies to manage diabetes, which is the need of the hour today. The RSSDI doctors conducting the trial will offer the app to their patients to download, and as the intervention progresses, study how it impacts their patients and their clinical management. “  Diabetes is a chronic disease that requires treatment for life. This makes adherence to blood sugar controlling lifestyle modifications such as healthy eating, physical activity, and timely medication mandatory. It is common for patients to make an error in their diabetes management by either overeating carbohydrates on a particular day, not exercising enough, or forgetting to take their medicine.  “From a patient safety perspective, the benefits offered by digital therapeutics are immense. Diabetes care needs to be continual versus the episodic care. Patient journey data is essential for the treating doctor to further personalize advice and pharmacological care. It is the ultimate win-win designed with a patient-centric approach, enhancing quality of care, access and affordability.” noted Mr. Shah.  The diabetes burden in India is enormous. As per data by the International Diabetes Federation, there are an estimated 69.1 million people living with diabetes in India and another 77.2 million with pre-diabetes. This is a high-risk condition for diabetes and cardio-vascular disease. The need of an hour is to manage this epidemic, using behavioural change in the population and only technology seems like the likely answer to scale it up at an economical cost. ]]> <![CDATA[Cipla gets USFDA approval for anti-asthma product]]> https://biospectrumindia.com/news/95/9851/cipla-gets-usfda-approval-for-anti-asthma-product.html https://biospectrumindia.com/news/95/9851/cipla-gets-usfda-approval-for-anti-asthma-product.html Mon, 20 Nov 2017 15:00:00 +0530 More than one billion people worldwide suffer from chronic respiratory diseases. Cipla is proud of its commitment to respiratory diseases with the introduction of Salbutamol tablets in 1976 and Salbutamol inhaler in 1978 in India. Since then Cipla has consistently introduced new products for asthma, Chronic Obstructive Pulmonary Disease (COPD) and Allergic Rhinitis (AR) and more recently in other diseases such as Pulmonary Arterial Hypertension (PAH), lung cancer and Idiopathic Pulmonary Fibrosis (IPF). Cipla received final approval from the US health regulator for a new suspension product used for treatment of asthma.   Cipla said "it has received final approval for its abbreviated new drug application (ANDA) for Budesonide Inhalation Suspension, 0.25mg/2mL, 0.5mg/2mL, and 1mg/2mL from the United States Food and Drug Administration (USFDA)". The approved product is a generic version of Astrazeneca's Pulmicort Respules, it added. Pulmicort Respules are indicated for maintenance treatment of asthma and as prophylactic therapy in children of 12 months to 8 years. Citing IMS Health data, Cipla said Pulmicort Respules and generic equivalents had US sales of approximately USD 825 million for the 12 months to September 2017. ]]> <![CDATA[Centre to allocate funds to develop pharma research in Nagpur]]> https://biospectrumindia.com/news/95/9850/centre-to-allocate-funds-to-develop-pharma-research-in-nagpur.html https://biospectrumindia.com/news/95/9850/centre-to-allocate-funds-to-develop-pharma-research-in-nagpur.html Mon, 20 Nov 2017 14:35:00 +0530 The central government is prepared to allocate Rs200 to 400 crore to universities to encourage pharmaceutical research and training, said union transport minister Nitin Gadkari in Nagpur. The minister was addressing pharmacists at a national seminar organized by Central India Pharmacy Promotion and Research Association (Cippara) at a city hotel on Saturday. Gadkari also suggested setting up of a centre for sickle cell and thalassemia patients in north Nagpur and invited pharmaceutical companies to establish manufacturing units in special economic zone (SEZ) in Mihan and MIDC Hingna. "There is a lot of potential for the pharmaceutical industry to grow in Nagpur given its central location. The city is also being developed as a logistics hub which will allow swift transportation of manufactured products here," said Gadkari. Gadkari urged universities to develop their pharmaceutical departments to be able to conduct research and provide training to pharmacy students. "A strong infrastructure will create a good opportunity because there are already special degree courses in pharmacy and people with good technical abilities," he said. The minister estimates that a sickle cell and thalassaemia centre will cost around Rs15 crore to build and another Rs25 crore each year for maintenance. Gadkari said, "It has been brought to my attention that cases of the two diseases have been growing among the Scheduled Castes and Scheduled Tribes community in north Nagpur. The situation is similar in districts like Bhandara, Gadchiroli, Gondia and Chandrapur. A speciality centre would serve the patients in the region." The minister said that though the construction of All India Institute of Medical Science (AIIMS) in the city has stalled, he will follow it up with the ministries concerned. By that time, he said, such projects should be contracted to private companies. ]]> <![CDATA[Eurofins takes over Spectro Analytical Lab]]> https://biospectrumindia.com/news/95/9833/eurofins-takes-over-spectro-analytical-lab.html https://biospectrumindia.com/news/95/9833/eurofins-takes-over-spectro-analytical-lab.html Fri, 17 Nov 2017 12:30:00 +0530 A global leader in bioanalytical testing, Eurofins Scientific, recently announced the acquisition of Spectro Analytical Labs, a leading environment, analytical product testing and inspection company in India.The company has over 22 years of experience in quality testing and inspection-related services, and owns accreditations from the National Accreditation Board for Testing and Calibration Laboratories (NABL) in six fields: Chemical, Mechanical, Biology, Non-destructive Testing, Calibration and Electrical and Electronics. Starting from a small facility in New Delhi, Spectro has steadily achieved strong growth to become India’s leading environment and analytical laboratory with operations and joint ventures all over the country, catering to more than 8,000 customers. The company operates 5 state-of-the-art laboratories in India, with a total surface area of ca. 10,000 m2, and employs close to 450 staff.The acquisition of Spectro will enable Eurofins to have a strong environment and analytical testing market entry in India and significantly increase Eurofins’ market position in this geographical region. This transaction is another demonstration of Eurofins’ commitment to expand its global network of analytical services laboratories across all geographical regions where it anticipates significant growth. ]]> <![CDATA[Technology Development Board enters into an agreement with Panacea Biotech]]> https://biospectrumindia.com/news/95/9828/technology-development-board-enters-into-an-agreement-with-panacea-biotech.html https://biospectrumindia.com/news/95/9828/technology-development-board-enters-into-an-agreement-with-panacea-biotech.html Thu, 16 Nov 2017 12:55:00 +0530 Technology Development Board which is a part of department of science and technology enters into an agreement with Panacea Biotec Pvt Ltd. for the late stage development including Phase II & III of the attenuated dengue vaccine. An agreement has been signed on 14th November 2017; and the trials are expected to be completed by 2019. Dengue is a mosquito-borne flavivirus disease that has spread to most tropical and many subtropical areas. Caused by four closely related viruses, the Dengue viruses 1-4, there are no specific dengue therapeutics; hence prevention limited to vector control measures is the most adopted method. A dengue vaccine would therefore represent a major advance in the control of the disease. There are many dengue vaccines under development, including live attenuated virus vaccines, live chimeric virus vaccines, inactivated virus vaccines, live recombinant, DNA, and subunit vaccines. Scientists at National institutes of Health (NIH), USA developed the attenuated strains of Dengue viruses that were tested in non-human primates for their safety and immunogenicity properties. The studies show that the attenuated viruses are able to replicate and trigger the generation of antibody response against each serotype, a primary requirement of a successful Dengue Vaccine. The vaccine strains did not have any adverse reactions and a challenge with respective wild type virus led to neutralization of the wild type viruses in immunized non-human primates.   As part of technology transfer, NIH USA has supplied fully characterized Virus seeds of the four Dengue Vaccine candidate viruses to PBL. Working further on this, PBL developed in-house process to produce the vaccine virus Drug Substance (DS); analytical methods to qualify the vaccine; and lyophilized formulation for longer stability.   PBL submitted a loan application to the TDB for setting up of a project envisaging “Development and commercialization of Dengue Tetravalent Vaccine (Live Attenuated, Recombinant, Lyophilized)” based on the technology licensed from NIH and perfected indigenously through in-house R&D.   ]]> <![CDATA[Sun Pharma develops machine for testing drug drop size]]> https://biospectrumindia.com/news/95/9826/sun-pharma-develops-machine-for-testing-drug-drop-size.html https://biospectrumindia.com/news/95/9826/sun-pharma-develops-machine-for-testing-drug-drop-size.html Thu, 16 Nov 2017 11:55:00 +0530 Pharma major Sun Pharmaceutical Industries has developed a machine for automatic drop size testing for measuring the weight of a drop of opthalmic drug dispensed from a plastic container. Sun Pharma is the first company to design and execute this machine and the company has filed critical products for regulated markets by generating data on this machine. This machine will be a benchmark to generate equivalency data in the future. Ophthalmic products are generally packed in a three-piece plastic container. It is important to design a perfect nozzle tip, which will deliver exact volume of the drug when the user squeezes the bottle and dispenses the drug into the eye. In regulated markets for ophthalmic products, the generic pharma companies need to show the equivalency of drop size as it has direct impact of drug assay. The machine consists of two servo motors, a sensitive weighing balance, a printer, special probes to simulate human finger forces, pressure gauge, PLC and MMI. The two micro servo motors fitted with special squeezing probes simulate the human finger operation. It has the capabilities to adjust both angle of dispensing and the squeeze force in order to measure the drop size of branded products and use that data to design the nozzle tip cap. The machine is also programmed to shake the bottle every time before it dispenses the drop to get uniform results. ]]> <![CDATA[Lakshminarayan joins Religare as Chairman]]> https://biospectrumindia.com/news/95/9813/lakshminarayan-joins-religare-as-chairman.html https://biospectrumindia.com/news/95/9813/lakshminarayan-joins-religare-as-chairman.html Wed, 15 Nov 2017 10:50:00 +0530 Religare Enterprises has appointed former Home Secretary S Lakshminarayanan as executive chairman after undergoing a major overhaul of its board. Following the board's decision, promoter Malvinder Mohan Singh will relinquish his position as non-executive chairman and also resigned as Chief Executive Officer (CEO) of the company. Lakshminarayanan is currently non-executive chairman of Shriram Transport Finance. The board has also roped in former Deputy Governor of Reserve Bank of India Kishori Udeshi. Chief executive Maninder Singh, chief financial officer Anil Saxena and company secretary Mohit Maheshwari stepped down with the board deciding to virtually induct a fresh management team. The company plans to sell a state through an issue of fresh shares. Promoters are in discussion with some of the overseas financial investors that include Shyam Maheshwari led Hong Kong-based SSG Capital and expect to close to the deal shortly. The board also decided to raise fund through issue of fresh shares in Religare Enterprise and its subsidiaries. The company is looking at strategic partnership with investors with complementary business.     ]]> <![CDATA[FDA approves new GONAL-f Prefilled Pen by Merck]]> https://biospectrumindia.com/news/95/9803/fda-approves-new-gonal-f-prefilled-pen-by-merck.html https://biospectrumindia.com/news/95/9803/fda-approves-new-gonal-f-prefilled-pen-by-merck.html Tue, 14 Nov 2017 11:05:00 +0530 Merck, a leading science and technology company, has received approval for a new version of GONAL-f (follitropin alfa injection) prefilled pen from the U.S. Food and Drug Administration (FDA). Known as GONAL-f RFF Redi-ject prefilled pen in the U.S. and originally approved by the FDA in 2013, the new version of the pen is easy-to-learn and easy-to-use. Aspiring to be an integrated fertility treatment partner, our strategy focuses on developing user-friendly treatment options for patients," said Luciano Rossetti, Head of Global Research and Development, at the biopharma business of Merck. "We understand that the best drivers for innovation come from insights from the people using our products. Their advice was a significant factor in the development of the new version of the GONAL-f prefilled pen." To date, an estimated 2.5 million babies have been brought to the world with the help of Merck fertility products and services. GONAL-f is the only gonadotropin that comes in prefilled, ready-to-use pen in the U.S. The new GONAL-f pen, like its predecessor, enables a fine-tuning of treatment allowing for minimum increments of 12.5 IU to titrate a wide range of doses and precisely target the dosing to patients' needs. In addition, its new design features include an amendment to the dose display window for readability. Patients suffering from infertility are a key focus for Merck as the company continuously seeks to expand its fertility offering. The latest version of the GONAL-f prefilled pen is the most recent addition to Merck's growing portfolio to support women and couples faced with infertility in the U.S., where one in six couples is affected by infertility. ]]> <![CDATA[Roche appoints Lara Bezerra as MD, Roche Pharma India]]> https://biospectrumindia.com/news/95/9812/roche-appoints-lara-bezerra-as-md-roche-pharma-india.html https://biospectrumindia.com/news/95/9812/roche-appoints-lara-bezerra-as-md-roche-pharma-india.html Mon, 13 Nov 2017 20:10:00 +0530 Roche has announced the appointment of Lara Bezerra as Managing Director for Roche Products (India) Pvt. Ltd. She succeeds Maturin Tchoumi who has now moved to Roche Finland in a new role. Lara has held various positions of leadership across geographies, including Europe and Latin America. With over 24 years of experience in the pharmaceutical industry, Lara comes to India after a successful assignment as the General Manager of Roche Venezuela. Her tenure in Venezuela was among the most turbulent times in the country’s history, and her leadership was critical in navigating that period. In 2016, Roche was named among the Top 20 Places to Work in Venezuela.  “We are delighted to have Lara Bezerra join Roche India from Venezuela,” says Dr. Christiane Hamacher, Region head of Roche Pharmaceutical Asia Pacific. “With her strong business acumen and unique, people-centric leadership approach, Lara is ideally positioned to drive Roche’s efforts to bring our innovative treatments to patients in India.” “I am excited to join the India team that has already made significant strides in bringing innovative healthcare solutions here,” says Lara Bezerra. “I look forward to building on this foundation by bringing our transformational medicines to the country, being a strong healthcare partner and making a meaningful difference for patients in India.” Lara has a degree in Business Administration from the Fundacao Getulio Vargas (FGV) University, Sao Paulo, Brazil. Source ET ]]> <![CDATA[Equashield signs deal with Transmedic to provide protection for Healthcare Workers]]> https://biospectrumindia.com/news/95/9785/equashield-signs-deal-with-transmedic-to-provide-protection-for-healthcare-workers.html https://biospectrumindia.com/news/95/9785/equashield-signs-deal-with-transmedic-to-provide-protection-for-healthcare-workers.html Thu, 09 Nov 2017 15:00:00 +0530 Equashield Signs Exclusive Distribution Deal with Singapore's Transmedic Pte Ltd to Provide Superior Protection for Healthcare Workers Equashield is leading provider of Closed System Transfer Devices (CSTDs) for the safe and simple handling of hazardous drugs. It is expanding globally by announcing today a new exclusive partnership in Singapore with distributor Transmedic Pte Ltd. "After comparing many clinical studies, it was clear to us that Equashield's system provides a higher level of safety and ease-of-use compared with other competing CSTDs," said Teo Kee Meng, Managing Director of Transmedic Pte Ltd. "Equashield is the pacesetter in the closed systems market. We are pleased to offer its leading solutions to Singapore healthcare facilities, and are confident that our customers will see the quality and safety inherent in Equashield's devices." Stated by Teo Kee Meng Singapore is an advanced market in its approach to safe handling practices, with CSTD-use supported by government regulations. Singapore's Ministry of Manpower's Workplace Safety and Health Council suggests the use of CSTDs in both, the compounding and administration of hazardous drugs.  "We are pleased that Transmedic Pte Ltd, a specialist in advanced medical technologies in Asia, has become our trusted partner in Singapore," said Adi Shor, VP of Sales, ROW for Equashield.  Acording to Adi Shor(VP, of Sales), With Transmedic's strong regional network, including offices in Malaysia, Indonesia, Hong Kong, Vietnam and the Philippines, Equashield and Transmedic can work together to support the safety of compounding pharmacy practitioners throughout the Asia Pacific region. This new cooperation with Transmedic Pte Ltd continues Equashield's global expansion, following the October announcement of Equashield's expansion to Portugal with its Spanish distributor, Palex Medical.   ]]> <![CDATA[Abbott pioneers unique dosing device in India]]> https://biospectrumindia.com/news/95/9784/abbott-pioneers-unique-dosing-device-in-india.html https://biospectrumindia.com/news/95/9784/abbott-pioneers-unique-dosing-device-in-india.html Wed, 08 Nov 2017 15:50:00 +0530 Abbott has pioneered in India LiDoCon, short for Liquid Dosing Concept, a first of its kind device for liquid medicines that provides accurate, hygienic and convenient dosing. This novel technology currently is being used for a cough syrup, but in time, will be extended to different types of liquid formulations. LiDoCon was conceptualized at Abbott’s Innovation and Development Center in Mumbai. "Our goal is to help people get and stay healthy. If you’re taking medicine to get better, you have to know you’re getting the right amount," said Raviraj Pillai, Head of Abbott’s pharmaceutical Innovation and Development Center in Mumbai. "Our new LiDoCon dosing device is simple, compact and helps avoid spillage and product contamination. This provides safer, more accurate and convenient dosing of liquid medicines, ultimately making it easier for people to take their medicine and get better." The special LiDoCon cap is locked on to the neck of the bottle. By a simple four-step process of "Fill, Invert, Lock and Revert," a specific amount of liquid is dispensed, ensuring that there is no backflow. A premeasured quantity is dispensed from the bottle, which means that no washing is required. This greatly reduces risk of contamination and reduces overall preparation time. The insights behind LiDoCon originally came from an Abbott employee in Mumbai, whose son suffers from asthma. His family experienced the herculean task of constantly cleaning and keeping track of the various dispensing caps from his son’s multiple syrups. That is when he approached Abbott’s innovation team for a solution. LiDoCon was born of a practical need felt by a parent so that monitoring of dosage and hygiene could be made easy.  Physicians across the country have shown a positive response to this new dosing technique. LiDoCon ensures that only a measured amount is dispensed, and hence prevents overdosing and accidental ingestion of a large amount of liquid. ]]> <![CDATA[QuintilesIMS is now IQVIA]]> https://biospectrumindia.com/news/95/9783/quintilesims-is-now-iqvia.html https://biospectrumindia.com/news/95/9783/quintilesims-is-now-iqvia.html Wed, 08 Nov 2017 14:55:00 +0530 QuintilesIMS has announced that it will be changing its name to IQVIA, a company dedicated to using analytics and science to help healthcare stakeholders find better solutions for their patients, effective November 6, 2017. IQVIA’s client solutions are powered by the IQVIA CORE. The CORE enables IQVIA to provide customized solutions for clients leveraging the world’s largest curated healthcare information source, advanced analytics, leading technologies and extensive industry knowledge across diseases, geographies, and scientific methods. It fuels the company’s approach to human data science, including faster, more predictable clinical development, innovative approaches to generating real-world evidence, machine learning to improve patient care, and strategies for precision commercial engagement. The seamless integration of these elements from molecule to market enables our customers to drive enhanced value, access and health outcomes around the world. Beginning on November 15, 2017, equity shares of the company will trade on the NYSE under the new name and new ticker symbol “IQV.” Until then, IQVIA will continue to be listed under QuintilesIMS and symbol “Q” per the listing notification requirements of the NYSE. Ari Bousbib, IQVIA Chairman and CEO said, “Our clients have been instrumental in our becoming IQVIA. IMS Health and Quintiles came together because our clients were asking for better, faster ways to bring innovations to patients and capture the improvements the industry has been pursuing for years.” “Since the merger, we’ve worked to integrate our capabilities in advanced analytics, leading technologies and therapeutic expertise into powerful, differentiated offerings. Our vision is to outpace the inevitable progress of change across the life sciences and accelerate our ability to empower healthcare decision makers to meet the future head on”, added Ari “IQVIA’s ongoing commitment to data security and privacy protection measures and decades of deep, practical experience are critical drivers of our global leadership. As a company, we will continue to engage in a wide variety of governance practices and administrative, technical and physical safeguards and controls to protect individual privacy. We work closely with data protection authorities, trusted third parties and privacy experts around the world to ensure we are diligent in the protection of individual privacy.” ]]> <![CDATA[Lupin gets warning letter from USFDA for Goa, Indore units ]]> https://biospectrumindia.com/news/95/9782/lupin-gets-warning-letter-from-usfda-for-goa-indore-units-.html https://biospectrumindia.com/news/95/9782/lupin-gets-warning-letter-from-usfda-for-goa-indore-units-.html Wed, 08 Nov 2017 14:40:00 +0530 Pharma company Lupin has announced that it has received warning letter from the US health regulator for its manufacturing facilities in Goa and Indore.  According to the company statement, "The company has received a warning letter issued by the United States Food and Drug Administration (USFDA) on November 6, 2017 for our formulation manufacturing facilities at Goa and Indore (Pithampur Unit II). The company had earlier received three form 483 observations for the Goa facility on April 7, 2017 and six form 483 observations for Pithampur (Unit II) on May 19, 2017, and responded to all the observations.” The company is deeply disappointed to have received this outcome, adding that while there will be no disruption of product supplies from either of these locations, there is likely be a delay of new product approvals. We plan to address the concerns raised by the USFDA expeditiously and will work with the USFDA to resolve these issues at the earliest.” The company upholds quality and compliance issues with utmost seriousness and remains fully committed to be compliant with cGMP quality standards across all the facilities, it added.    ]]> <![CDATA[Generic Azacitidine for injection in Canadian market launched by Dr Reddy’s lab]]> https://biospectrumindia.com/news/95/9778/generic-azacitidine-for-injection-in-canadian-market-launched-by-dr-reddys-lab.html https://biospectrumindia.com/news/95/9778/generic-azacitidine-for-injection-in-canadian-market-launched-by-dr-reddys-lab.html Tue, 07 Nov 2017 12:45:00 +0530 Dr. Reddy’s Laboratories Ltd. has announced the launch of generic Azacitidine for injection 100 mg/vial in the Canadian Market. Azacitidine is a bioequivalent generic version of VIDAZA® approved by Health Canada. Alok Sonig, Executive Vice President and Head of the North America Generics business, Dr. Reddy’s Laboratories said, “Bringing Azacitidine for Injection to the Canadian market at this time is very important for us, as well as for our customers and their patients. This launch represents Dr. Reddy’s commitment to make affordable injectable drugs available in Canada.” Dr. Reddy’s is first to market with this Azacitidine for injection in Canada. Vinod Ramachandran, Ph.D., Country Manager, Dr. Reddy’s Canada said, “The approval and launch of Azacitidine for injection is an important milestone for Dr. Reddy's in Canada. The launch of first generic Azacitidine for injection is another step in our long-term commitment to bring more cost-effective options to Canadian patients.” ]]> <![CDATA[Generic acticlate tablets launched by Lupin in USA ]]> https://biospectrumindia.com/news/95/9773/generic-acticlate-tablets-launched-by-lupin-in-usa-.html https://biospectrumindia.com/news/95/9773/generic-acticlate-tablets-launched-by-lupin-in-usa-.html Mon, 06 Nov 2017 15:05:00 +0530 Pharma Major Lupin announced the launch of its Doxycycline Hyclate Tablets USP, 75 mg and 150 mg after an approval from the United States Food and Drug Administration (FDA). Lupin’s Doxycycline Hyclate Tablets USP, 75 mg and 150 mg are the AB rated generic equivalent of Aqua Pharmaceuticals, LLC’s Acticlate® Tablets, 75 mg and 150 mg. They are indicated in the treatment of infections caused by various microorganisms and as an adjunctive therapy in severe acne. Doxycycline Hyclate Tablets USP, 75 mg and 150 mg had annual sales of approximately USD 263 million in the US (IMS MAT June 2017).   ]]> <![CDATA[Alembic Pharma acquires Orit Laboratories]]> https://biospectrumindia.com/news/95/9768/alembic-pharma-acquires-orit-laboratories.html https://biospectrumindia.com/news/95/9768/alembic-pharma-acquires-orit-laboratories.html Fri, 03 Nov 2017 15:10:00 +0530 Gujarat-based drugmaker Alembic Pharmaceuticals Ltd has bought US-based generic drug developer Orit Laboratories LLC from Okner Realty LLC in its first cross-border acquisition.The acquisition increases Alembic’s US product portfolio with seven approved and four pending Abbreviated New Drug Applications (ANDA). Alembic will now have 69 ANDA approvals from the US Food and Drug Administration. Orit, based in New Jersey, was founded in 2005 by Satish Patel. It has an 8,600 square feet R&D and pilot manufacturing facility. Patel will join Alembic Group along with eight other scientists. Orit will also bring complementary skills sets in soft gelatin-based oral solid and liquid products. The acquisition reflects the Alembic’s ambition to grow its US generics business in a measured way. It will also expand the company’s basket of product offerings to the customers, showing commitment to be a long-term player in the US generic industry, and will help the company establish a powerful R&D footprint in the US. ]]> <![CDATA[Serum aims high revenue growth through new launches]]> https://biospectrumindia.com/news/95/9757/serum-aims-high-revenue-growth-through-new-launches.html https://biospectrumindia.com/news/95/9757/serum-aims-high-revenue-growth-through-new-launches.html Wed, 01 Nov 2017 13:10:00 +0530 Serum Institute of India, at Pune, aims to achieve revenues of Rs 10,000 crore in the next five years period through new launches and expanding footprints in Europe and US. The company is developing vaccine and drug for dengue fever. It has commenced first phase of trials in Singapore and hopes to launch vaccine in 2020. The company has also launched Rotasiil vaccine and Rabishield, Rabies monoclonal antibody which will help in achieving 30 per cent growth this year. The availability of Rotasiil and Rabishield worldwide will help reduce deaths caused due to Rotavirus and Rabies which cause fatal diseases. Rabishield has been developed in research partnership with Massachusetts Medical School, US. Rabishield will be 25 per cent cheaper than the existing rabies immunoglobulins, it would meet the needs of the poor countries Serum intends to launch more vaccines in coming years. It is the world's largest manufacturer of vaccines and sells about 1.3 billion doses a year globally across 147 countries.       ]]> <![CDATA[Lupin receives FDA approval for generic Axiron topical solution]]> https://biospectrumindia.com/news/95/9735/lupin-receives-fda-approval-for-generic-axiron-topical-solution.html https://biospectrumindia.com/news/95/9735/lupin-receives-fda-approval-for-generic-axiron-topical-solution.html Fri, 27 Oct 2017 11:50:00 +0530 Pharma Major Lupin has received final approval for its Testosterone Topical Solution, 30 mg per actuation from the United States Food and Drug Administration (FDA) to market a generic version of Eli Lilly and Company’s Axiron® Topical Solution, 30 mg per actuation. Lupin’s Testosterone Topical Solution, 30 mg per actuation is therapeutically equivalent to Eli Lilly and Company’s Axiron® Topical Solution, 30 mg per actuation. It is indicated for replacement therapy in males for conditions associated with a deficiency or absence of endogenous testosterone. Testosterone Topical Solution, 30 mg per actuation, had annual sales of approximately USD 244.2 million in the US. (IMS MAT June 2017). ]]> <![CDATA[Lupin receives FDA approval for generic Lodosyn tablets and Kapvay Extended-Release tablets]]> https://biospectrumindia.com/news/95/9734/lupin-receives-fda-approval-for-generic-lodosyn-tablets-and-kapvay-extended-release-tablets.html https://biospectrumindia.com/news/95/9734/lupin-receives-fda-approval-for-generic-lodosyn-tablets-and-kapvay-extended-release-tablets.html Fri, 27 Oct 2017 11:45:00 +0530 Pharma Major Lupin has announced that it has received final approval for its Carbidopa Tablets, 25 mg and Clonidine Hydrochloride Extended-Release Tablets, 0.1 mg from the United States Food and Drug Administration (FDA) to market a generic version of Aton Pharma, Inc.’s Lodosyn Tablets, 25 mg and generic version of Concordia Pharmaceuticals Inc.’s Kapvay Extended-Release Tablets 0.1 mg respectively. Lupin’s Carbidopa Tablets, 25 mg is the AB rated generic equivalent of Aton Pharma, Inc.’s Lodosyn Tablets, 25 mg. It is indicated for use with carbidopa-levodopa or with levodopa in the treatment of the symptoms of idiopathic Parkinson’s disease (paralysis agitans), postencephalitic parkinsonism, and symptomatic parkinsonism, which may follow injury to the nervous system by carbon monoxide intoxication and/or manganese intoxication. Clonidine Hydrochloride Extended-Release Tablets, 0.1 mg is the AB rated generic equivalent of Concordia Pharmaceuticals Inc.’s Kapvay® Extended-Release Tablets 0.1 mg. It is indicated for the treatment of attention deficit hyperactivity disorder (ADHD) as monotherapy or as adjunctive therapy to stimulant medications. Carbidopa Tablets, 25 mg had annual sales of approximately USD 21.9 million in the US (IMS MAT June 2017). Clonidine Hydrochloride Extended-Release Tablets, 0.1 mg had annual sales of approximately USD 66 million in the US. (IMS MAT Jun 2017).   ]]> <![CDATA[Ayurveda Attracts US Students to India]]> https://biospectrumindia.com/news/95/9729/ayurveda-attracts-us-students-to-india.html https://biospectrumindia.com/news/95/9729/ayurveda-attracts-us-students-to-india.html Thu, 26 Oct 2017 16:25:00 +0530 Ayurveda, regarded as the mother of all medical sciences in the world, is increasingly attracting educated Western citizens to India, especially youth from the US who have shed their hippy-dippy image and started embracing organic food and lifestyle habits as never before. A 25-member postgraduate students' team, primarily comprising of US nationals, had their first exposure to the ancient healthcare tradition that has been practiced in India for 5,000 years at Sukhayus, a heritage wellness retreat at Fort Kochi, India by Punarnava Ayurveda Hospital, the globally acclaimed Ayurveda curative brand from India that has catered to thousands of patients from across the world during the last 25 years. The student tour was coordinated by Dr. Jaime Llambias-Wolff, Associate Professor at Division of Social Science, York University, Toronto and the group comprised of postgraduate students from various US universities. The visit to Punarnava was as part of a global tour to expose students to other systems of medicines that are in practice across the world. Dr. Jaseela Anvar, BAMS, MS, Medical Director of Punarnava Ayurveda led the scientific sessions on Ayurveda, she introduced students to the basics of Ayurveda, explained how it works in curative and wellness perspectives. Delegates actively participated in the sessions to better understand the Ayurveda approach towards managing various lifestyle disorders, degenerative autoimmune diseases and developmental delay in children. Students were exposed to Panchakarma process with the support of a live demonstration. A team of specialist doctors and researchers at Punarnava addressed their specific queries on Ayurveda, Yoga, and Naturopathy as well. "Ayurveda has influenced the origin and evolution of many other traditional systems of healing in the world. A precise blend of Ayurveda and other interdisciplinary sciences along with modern diagnostics can work wonders in the management of many degenerative and auto-immune spectrum of disorders," said Dr. A.M. Anvar, Chairman and Managing Director of Punarnava Ayurveda. "The recent years have witnessed an increased influx of students of Ayurveda from various countries especially the West and many of them are from reputed medical universities. This is a definite indication towards the widening acceptance for Ayurveda globally, and we are considering a global roadshow to take Ayurveda to more countries as part of our silver jubilee initiatives," said Dr. A.M. Anvar. ]]> <![CDATA[CertiTrek Group launches International Medical Assistant Certification in India]]> https://biospectrumindia.com/news/95/9728/certitrek-group-launches-international-medical-assistant-certification-in-india.html https://biospectrumindia.com/news/95/9728/certitrek-group-launches-international-medical-assistant-certification-in-india.html Thu, 26 Oct 2017 16:15:00 +0530 Specialty Certified Medical Assistant (SCMA), a medical certification business unit of the CertiTrek Group announced the launch of its anchor program, International Medical Assistant Certification. SCMA also made the new course a pre-requisite for all their speciality programs offered. SCMA has been focusing on training and certifying medical assistants in more than 13 specialised practice areas. The International Medical Assistant Certification introduces an advanced curriculum to assess a medical assistant on international healthcare standards of practice and laws. The certification is aimed at entrusting medical assistants with clinical knowledge, professional behaviour & approach, and administrative accords of assistance. The certification is an encouraging step in the direction of skill development in India, focusing on creating valuable talent that can act as a backbone in supporting the healthcare industry. Dr. Ruchi Girotra, President, SCMA, suggests, "Over the past 12 months, healthcare employment has increased by 328,000 jobs and is at a fast growing rate with healthcare services improving in India and various government initiatives, providing healthcare to all. With our International Medical Assistant Certification, we are determined at bringing job-ready medical assistants to keep up with the talent needs of the healthcare industry." Postulated for a senior secondary pass-out as a pre-requisite of the course, International Medical Assistant Certification would focus on skilling staff for the healthcare industry, employable across spectrums like hospitals, outpatient care units, physicians and other healthcare facilities. The courses would be offered at various partnering centres across India starting from the first week of November. ]]> <![CDATA[US company expands its Irish campus]]> https://biospectrumindia.com/news/95/9727/us-company-expands-its-irish-campus.html https://biospectrumindia.com/news/95/9727/us-company-expands-its-irish-campus.html Thu, 26 Oct 2017 15:30:00 +0530 US biotech company Regeneron Pharmaceuticals revealed plans to create some 300 new jobs in Ireland's Limerick County. The jobs form part of a US$100m (€85m) expansion plan for the company's campus there. The site in Limerick was opened in 2014 and classifies as one of the largest biologic production operations in the world. The 300 new jobs will come on top of 500 existing ones. The expansion is expected to be finished by the end of 2018. Regeneron plans to hire specialists in commercial manufacturing, process sciences, quality assurance/control/validation, chemistry and various support functions. Dan Van Plew, Executive Vice President and General Manager of Industrial Operations and Product Supply at Regeneron, said, “Gut feel is a large portion of any site selection. When we picked Limerick years ago, we simply felt good about the community, universities and people. A few years and a lot of experience later, I can now confidently say I know Limerick is a place where you can build and thrive as a biotech.“ Van Plew described the Limerick site as Regeneron’s bridge head in Europe. The latest investment of US$100m (€85m) by Regeneron brings the total investment sum at the site to US$750m. The money will support the construction of a number of manufacturing suites to increase drug substance production capacity, Regeneron stated. The campus, dubbed Industrial Operations and Product Supply (IOPS) facility, is responsible for the production, packaging, labelling and delivery of Regeneron medicines. The expansion is supported by the Irish government through IDA Ireland. ]]> <![CDATA[Midmark India develops motorised bed 'Electra' for Indian hospitals]]> https://biospectrumindia.com/news/95/9726/midmark-india-develops-motorised-bed-electra-for-indian-hospitals.html https://biospectrumindia.com/news/95/9726/midmark-india-develops-motorised-bed-electra-for-indian-hospitals.html Thu, 26 Oct 2017 14:40:00 +0530 Midmark (India), a leader in the area of patient positioning equipment, has now developed a motorised bed 'Electra', designed to capture a new market in the country’s  tertiary care sector. The new bed manufactured and designed entirely in India aims to revolutionize the traditional hospital bed. It is designed to enhance patient comfort and caregiver efficiency. Priced between the range of INR 1,30,000 to INR 1,50,000 it is advanced but simpler to use at the same time. Based out of Ohio, Midmark Corporation has been the first in India to develop intensive care bed, emergency and recovery trolleys, two section labour tables, India’s first electrically operated hospital bed and has sales and technical support network across India in its category. It was  formerly known as Janak Healthcare tgat was established in 1951. According to  Sumeet Aggarwal, managing director, Midmark(India), Electra is powered by the most experienced and largest customer support network in India which will result in a lower cost of ownership. The company is looking to increase sales of motorised beds by 20% overall. Through the launch of Electra, we look forward to meet the growing demand of quality motorised beds in India and enter competitive global markets like Africa, Latin America and East Europe over the next 2 years, he added. “As always, safety and flexibility are the hallmarks of any Midmark India product and Electra is no different. It is well equipped to keep the patients rested with its versatile and smoothly attained clinical positions ensuring complete contouring”, stated Aggarwal. Electra is in compliance with IEC 60601-2-52, the latest safety international standards for hospital beds. Its anti-microbial powder coat and an uncluttered access to all its segments make the bed easy to clean for a better infection control. It has an adjustable platform that can be lowered to a minimum height, ensuring comfort and safety to the patients by providing them with an easy entry and exit to the bed. It can also be increased up to a maximum height making it easy for the caregivers to easily access and deliver healthcare from a secure position.  ]]> <![CDATA[Nightingales collaborates with Amplifon to bring hearing home]]> https://biospectrumindia.com/news/95/9715/nightingales-collaborates-with-amplifon-to-bring-hearing-home.html https://biospectrumindia.com/news/95/9715/nightingales-collaborates-with-amplifon-to-bring-hearing-home.html Wed, 25 Oct 2017 15:05:00 +0530 Bangalore based company, Nightingales Home Health Services has announced its association with Amplifon. Amplifon is an award winning company for providing the best hearing care solutions and treatments in India. Through this association, Nightingales and Amplifon are providing hearing aid services to anyone in need within the comfort of their homes. This service will be available in Bangalore, Mumbai, Pune and Hyderabad. According to statistics, in India, 6.3% of the population (63 million) suffers from hearing loss. The estimated prevalence of adult onset deafness was found to be 7.6% and childhood onset to be 2%. Four in every thousand children are born with severe to profound hearing loss. It has been noted by the WHO that half the causes of deafness are preventable and about 30%, though not preventable, are treatable or can be managed with assistive devices. Thus, about 80% of all deafness can be said to be avoidable.  The severity of the hearing defect can be measured in several ways. While the main procedure involves how well a patient responds to a normal speech or whispers, the tests are segregated into mainly two categories. The first procedure involves tests on how difficult it is for the patient to maintain constant speech intensity and secondly, it is tested whether the patient is particularly impaired at a certain frequency range. Nightingales’ collaboration with Amplifon also aims at revolutionizing the method of detecting hearing loss by testing at home. This enables the audiologist to test the hearing capacity of a patient in a regular environment with noise and disturbance which they are exposed to on a daily basis. This set up increases accuracy in comparison to a test conducted in a sound proof room. Speaking on the occasion, Lalit Pai, CEO and Co-founder of Medwell Ventures said, “Nightingales witnessed an overwhelming response to providing hassle free dental services in the comfort of your home. While speaking with our patrons, we felt the need to expand our offerings by adding specialized services such as providing hearing impairment solutions to our varied categories. With more than 60% of people over the age of 60 suffering from some degree of hearing impairment, loss of hearing is becoming a common household problem. Statistics suggest that 1/12th of the whole population suffer from some extent of hearing loss. While not many realize they have a problem, people across age groups have been diagnosed with early hearing impairment issues which could be resolved with timely medical assistance.”   ]]> <![CDATA[India’s generics exports expanding 22% per year]]> https://biospectrumindia.com/news/95/9709/indias-generics-exports-expanding-22-per-year.html https://biospectrumindia.com/news/95/9709/indias-generics-exports-expanding-22-per-year.html Tue, 24 Oct 2017 15:15:00 +0530 The India Brand Equity foundation (IBEF) and the Pharmaceuticals Export Promotion Council (PHARMEXCIL) provide an update on the country’s generics market as the world’s pharma industry meets for its annual exposition at CPhI Worldview in Frankfurt. Data confirms that the country’s branded generic sector accounts for a massive 98% of the marketplace – reaching a value in excess of US$12 billion – with India remaining the world’s leadingexporter. PHARMEXCIL confidently forecast that generic exports are now growing at around 22% per year, with India accounting for around 20-22% of the world’s production, covering more than 60,000 brands and 60 therapeutic classes. Total exports of pharmaceuticals – including APIs, generics and alternative systems of medicine – climbed to $16.84 billion during 2016-17, with 34% and 15% supplied to the US and EU markets respectively. Shri Ravi Udaya Bhaskar, Director General, Pharmexcil, commented: “A key driver for this growth is India’s extensive product portfolio, which provides the capability to manage and treat any ATC (Anatomical therapy classification) – to the same quality as the innovators  – at highly affordable costs.” According to the analysis India has provided up to 50% of new DMFs and between a quarter and a third of new ANDAs each year for the past decade – in addition to supporting hundreds of ANDAs filed by US and EU companies. The country was also credited with between 30% and 50% of the total CEPS between 2013 and 2017, including being the first to file generic drugs in the EU and the USA. Consequently, India now boasts 7 companies amongst the top 20 global generic organisations. Shri Ravi Udaya Bhaskar, added:“The industry has been working diligently towards enhancing its capabilities and strengths. This includes its more than 950 colleges, which deliver over 90,000 pharmaceutical graduates per year, of which, 30,000 have completed master’s degrees. Moreover, Government’s policies are directed at increasing infrastructure facilities to help enable manufacturing to reach its highest potential – with pharma exports expected to reach $20 billion by 2020.” ]]> <![CDATA[US FDA approves Bydureon BCise by AstraZeneca for type-2 diabetes]]> https://biospectrumindia.com/news/95/9699/us-fda-approves-bydureon-bcise-by-astrazeneca-for-type-2-diabetes.html https://biospectrumindia.com/news/95/9699/us-fda-approves-bydureon-bcise-by-astrazeneca-for-type-2-diabetes.html Mon, 23 Oct 2017 13:20:00 +0530 Biopharma company AstraZeneca has announced its US Food and Drug Administration (FDA) approved Bydureon BCise (exenatide extended-release) injectable suspension. The new formulation of Bydureon is an improved once-weekly, single-dose auto-injector device for adults with type-2 diabetes whose blood sugar remains uncontrolled on one or more oral medicines in addition to diet and exercise, to improve glycaemic control. Unlike other glucagon-like peptide-1 (GLP-1) receptor agonists, Bydureon BCise has a unique, continuous-release microsphere delivery system designed to provide consistent therapeutic levels of the active ingredient, exenatide, to help patients reach and maintain steady state. The new formulation in the innovative Bydureon BCise device is proven to reduce blood sugar levels, with the added benefit of weight loss. Across two clinical trials, average HbA1c reductions of up to 1.4% and average weight loss of up to 3.1 pounds (1.4 kilograms) were achieved when used as monotherapy or as an add-on to metformin, a sulfonylurea, a thiazolidinedione, or any combination of two of these oral anti-diabetic medicines at 28 weeks. The most common adverse reactions reported in ≥5% of patients in clinical trials were nausea (8.2%) and adverse events associated with injection-site nodules (10.5%). It will be available for patients in the US in the first quarter of 2018. A regulatory application for the new auto-injector device has also been accepted by the European Medicines Agency. Ruud Dobber, President, AstraZeneca US and Executive Vice President, North America said, “We know that physicians have established long-standing confidence in the significant HbA1c reduction Bydureon provides their patients to help achieve consistent control, with the added benefit of weight loss. With the approval of Bydureon BCise, we’re now introducing a new formulation in an improved, easy-to-use device that will help enhance the patient experience.”    ]]> <![CDATA[DGCI gives approval to AstraZeneca for marketing diabetes drug]]> https://biospectrumindia.com/news/95/9686/dgci-gives-approval-to-astrazeneca-for-marketing-diabetes-drug.html https://biospectrumindia.com/news/95/9686/dgci-gives-approval-to-astrazeneca-for-marketing-diabetes-drug.html Wed, 18 Oct 2017 11:10:00 +0530 Drug Controller General of India (DCGI) has given marketing authority to the drug firm AstraZeneca for Xigduo XR tablets used in treatment of adults with type 2 diabetes in India. The product is indicated as an adjunct therapy to diet and exercise to improve glycemic control in adults with type 2 diabetes. The company has not shared the price at which it would be selling the tablets. The drug has been approved in 61 countries, including the US, EU and Japan, and demonstrates an overall favourable benefit risk profile for treatment of patients with type 2 diabetes, The diabetes drug will provide physicians and patients with an advanced treatment option that provides better glycemic control, potential weight loss and the reduced risk of hypoglycemia. The product is approved with multiple dosage strengths of dapagliflozin and metformin hydrochloride extended-release, respectively, including 5 mg/500 mg, 5 mg/1,000 mg, 10 mg/500 mg, and 10 mg/1,000 mg. Through this tablet, the physicians will be offer a personalised and effective treatment option to manage the type 2 diabetes. ]]> <![CDATA[Hilleman Labs successfully completes Phase I/II Clinical Trial of its Rotavirus Vaccine ]]> https://biospectrumindia.com/news/95/9655/hilleman-labs-successfully-completes-phase-i-ii-clinical-trial-of-its-rotavirus-vaccine-.html https://biospectrumindia.com/news/95/9655/hilleman-labs-successfully-completes-phase-i-ii-clinical-trial-of-its-rotavirus-vaccine-.html Thu, 12 Oct 2017 16:45:00 +0530 Hilleman Laboratories has announced the successful completion of Phase I/II clinical trial of its oral vaccine against the deadly Rotavirus disease. The study was conducted in partnership with the International Centre for Diarrhoeal Disease Research, Bangladesh (icddr). Hilleman is a joint venture between Merck Sharp & Dohme (MSD) and the Wellcome Trust. The results of the study were presented at the Vaccines for Enteric Disease Conference 2017, held in Albufeira, Portugal. This clinical study was initiated in April 2016 after successful completion of the preclinical animal studies and after obtaining regulatory clearance for human studies. After successful completion of the Preclinical animal studies and obtaining regulatory clearance for human studies, Hilleman Laboratories had initiated a clinical study in April 2016, to establish proof-of-concept for its heat stable Rotavirus vaccine. The vaccine is aimed at allowing greater temperature stability and less reliance on exact storage timing and refrigeration. Sharing results of the study, Dr K. Zaman, Senior Scientist and Epidemiologist at icddr said, “Safety data have demonstrated that administration of HSRV, when compared with placebo, did not result in an increased reporting of solicited AEs in the adult cohort. In infants when administered as 3-dose primary series, HSRV had a safety profile similar to RotaTeq in terms of frequency, severity, and causality of solicited adverse effect.” "Immunogenicity assessment was found to be comparable between the HSRV and RotaTeq in infants. The percentage of infants exhibiting a 3-fold rise in serum anti-rotavirus IgA at 1 month post-dose 3 administration from baseline in HSRV group was 88%. The percentage of infants who had a similar increase in the RotaTeq group was 84%. In addition, HSRV elicited comparable Geometric Mean Titre relative to RotaTeq, 1 month after completion of 3-dose vaccination schedule. Based on the encouraging results obtained in this study, HSRV will be further evaluated in immunogenicity and safety studies in infants.” Dr Davinder Gill, CEO Hilleman Laboratories said, “Rotavirus is the leading cause of severe diarrhoea and related deaths in children less than 5 years worldwide. First-generation Rotavirus vaccines possess thermostability profiles that may not meet storage requirements in developing countries, highlighting the need for heat stable vaccines. Considering the urgent need for effective and affordable Rotavirus vaccines, we would like to accelerate development of our simplified, easy-to-use, heat stable vaccine.”   v ]]> <![CDATA[Hilleman Labs achieves successful outcome of Phase I/II clinical trial of cholera vaccine]]> https://biospectrumindia.com/news/95/9654/hilleman-labs-achieves-successful-outcome-of-phase-i-ii-clinical-trial-of-cholera-vaccine.html https://biospectrumindia.com/news/95/9654/hilleman-labs-achieves-successful-outcome-of-phase-i-ii-clinical-trial-of-cholera-vaccine.html Thu, 12 Oct 2017 16:25:00 +0530 Hilleman Laboratories has announced the successful completion of Phase I/II Clinical Trials of its novel Oral Cholera Vaccine Hillchol. It was conducted in partnership with the International Centre for Diarrhoeal Disease Research, Bangladesh. The results of this clinical study were announced at the Vaccines for Enteric Diseases Conference 2017 recently held in Albufeira, Portugal. WHO statistics shows that Cholera is endemic in over 50 countries with estimated mortality of 100,000 - 120,000 deaths annually, and a morbidity of 3.8 - 4.4 million annual cases attributed to this disease. In 2014 Hilleman Laboratories partnered with Gotovax AB of Sweden and Incepta Vaccines of Bangladesh for the development of an affordable Cholera vaccine. Clinical trial design and development was supported by the International Centre for Diarrhoeal Disease Research, Bangladesh Sharing results of the clinical study, Dr. Ajit Pal Singh - Vice President Clinical R&D at Hilleman Labs stated, “Hillchol was tested in 840 subjects that included adults, adolescents as well as small children.  We were able to demonstrate safety and tolerability of HillcholTM in our Phase I/II trials.  Our vaccine consists of a novel Hikojima strain that expresses both the Ogawa and Inaba serotypes.  When compared against Shanchol, the Cholera vaccine pre-qualified by WHO, we could achieve non-inferiority in terms of seroconversion as well as Geometric Mean Titre for both the Ogawa and Inaba serotypes.  These results are very encouraging and warrant further development of our Cholera vaccine.” Dr. Tarun Sharma, Director R&D at Hilleman Labs stated, “The HillcholTM Phase I/II clinical trial results support our Hikojima vaccine design and mirror the impressive results we have been able to achieve in Preclinical studies.  This encourages us to conduct further clinical studies as well as undertake further research in our labs for additional innovations in next-generation Oral Cholera Vaccines” Talking about the accomplishment, Dr Davinder Gill, CEO Hilleman Laboratories said, “There is an urgent need for effective and affordable Cholera vaccines for use in both Cholera outbreaks and in mass vaccination campaigns. " "Currently, WHO recommends Oral Cholera Vaccines for humanitarian crises and in outbreaks.  With the advancement of HillcholTM, we hope to make available to the global health community, an affordable vaccine for mass vaccination in hotspots against Cholera-endemic countries.  This will greatly assist in the global initiative recently announced by WHO to reduce Cholera deaths by 90% by the year 2030", he added.   ]]> <![CDATA[Pfizer reviewing strategic alternatives for consumer healthcare business]]> https://biospectrumindia.com/news/95/9648/pfizer-reviewing-strategic-alternatives-for-consumer-healthcare-business.html https://biospectrumindia.com/news/95/9648/pfizer-reviewing-strategic-alternatives-for-consumer-healthcare-business.html Wed, 11 Oct 2017 16:15:00 +0530 Pfizer Inc. has announced that it is reviewing strategic alternatives for its Consumer Healthcare business. A range of options will be considered, including a full or partial separation of the Consumer Healthcare business from Pfizer through a spin-off, sale or other transaction, and Pfizer may ultimately determine to retain the business. Pfizer Consumer Healthcare is one of the largest OTC health care products businesses in the world with 2016 revenues of approximately $3.4 billion, operating in more than 90 countries globally. Ian Read, Pfizer Chairman and Chief Executive Officer said, “Pfizer Consumer Healthcare is a leading player in the largest OTC categories, with iconic brands, robust retail partnerships, global reach and strong fundamentals. Although there is a strong connection between Consumer Healthcare and elements of our core biopharmaceutical businesses, it is also distinct enough from our core business that there is potential for its value to be more fully realized outside the company. By exploring strategic options, we can evaluate how best to fuel the future success and expansion of Consumer Healthcare while simultaneously unlocking potential value for our shareholders.” Pfizer Consumer Healthcare develops, manufactures and markets leading non-prescription medicines, vitamins, and personal care products. Major categories and product lines include dietary supplements, pain management, gastrointestinal, respiratory. Albert Bourla, Group President, Pfizer Innovative Health said, “Consumers are taking more ownership of their health and wellness through OTC products, preventative treatments and alternative health paths. Pfizer Consumer Healthcare is playing an important role in changing the world’s well-being. Our colleagues are passionate about empowering consumers around the world to improve their health and wellness through our trusted brands, innovation, and thought leadership.”   ]]> <![CDATA[India’s first Global Consortium to unveil Collective Diagnostic Strength Of four Countries]]> https://biospectrumindia.com/news/95/9646/indias-first-global-consortium-to-unveil-collective-diagnostic-strength-of-four-countries.html https://biospectrumindia.com/news/95/9646/indias-first-global-consortium-to-unveil-collective-diagnostic-strength-of-four-countries.html Wed, 11 Oct 2017 15:40:00 +0530 Aggregating the fragmented diagnostic sector of the country, four nations joined forces to launch India’s first global Pathology Laboratory Consortium- Neuberg Diagnostics- today in Bangalore. Founded by the renowned healthcare entrepreneur, Dr. G.S.K.Velu, the international alliance brings together leading laboratories from India, Sri Lanka, South Africa and UAE under one umbrella, making it one among the top laboratory chains of the country from the day one of its inception, both in footprints and revenue. Neuberg Diagnostics (Neuberg literally translates to New City or New Neighbourhood apart from also being the namesake in honour of the Father of Modern Biochemistry, Carl Neuberg), was conceived with the goal to erase geographical borders and make the world of healthcare one, bringing advanced diagnostics affordable to people across the globe.  The conglomerate, which has a combined diagnostic expertise of over two centuries, is an alliance of top laboratories like Anand Diagnostic Laboratory, Supratech Micropath, Ehrlich lab, Global labs and Minerva Labs, which have already made their presence in their respective countries and states such as Karnataka, Gujarat, Tamil Nadu, South Africa & UAE Neuberg will have 3 world class global reference laboratories located in Bangalore, Ahmedabad, and Durban (South Africa) carrying out advanced range of testing using new generation In vitro diagnostics techniques along with total lab automation & big data analytics tools supported by robust world-class laboratory information system. These laboratories will have collective annual revenue of INR 400 crs with the formation of the new entity. Neuberg Diagnostics will operate under one corporate team headed by Dr. G.S.K.Velu as the Chairman, Mr. Anand K, will assume the role of Chief Executive Officer, while Dr. Sujay Prasad will be the Medical Director and Dr. Sandip Shah will be the Executive Director. The Technical Board will comprise of top pathologists like Dr. Jayaram, Dr. Bhagyam Nair, Dr. Lorna Madurai, and Dr. Bhavini Shah among others. The global brand was launched in the presence of the esteemed guests, Ms. Anupriya Patel, Minister of State in the Ministry of Health and Family Welfare, Government of India, Dr Rajitha Senaratne, Minister of Health, Nutrition & indigenous Medicine, Sri Lanka, Dr. Awatif Juma al Bahar, Medical director of Dubai Health Authority, UAE and Prof. Salim S Abdool Karim, Director of CAPRISA & Pro vice-chancellor, University of KwaZulu-Natal in Durban, South Africa along with the senior management officials of the brand.  With full throttle growth expected to take up Indian diagnostics in the near term, the new generation consortium will pool in cutting-edge advanced diagnostics technology and actively perform 5000 plus variety of pathological tests, promoting prevention and early diagnosis, thereby empowering the Indian healthcare consumer. In conjunction with providing comprehensive laboratory services, covering all areas of laboratory medicine, Neuberg will combine conventional pathology testing, new generation laboratory techniques and basic Radiology & imaging techniques for enhanced patient outcomes.  Dr. G.S.K.Velu, Chairman of Neuberg Diagnostics said, “The aim of the partnership is to develop a new shared services model for the provision of pathology services in the Middle East, Africa including west and South India. Neuberg Diagnostics is built on the vision to provide modern, innovative and sustainable services that deliver world-class lab facilities with the focus on high-end technology and services like Genomics and Proteomics to doctors and patients alike.”Anand.K, CEO of Neuberg Diagnostics added, “An association with the pathology experts will lead to the implementation of best practices, adoption of new technology and convert research into innovation, benefiting the medical community and ultimately improving patient care.”  Speaking about the new venture, Ms. Anupriya Patel, Minister of State for Health and Family Welfare, India said, “Indian healthcare delivery is growing by leaps and bounds. A global consortium is therefore set to be a major platform to introduce new generation pathology services to the sector, thereby increasing the quality and affordability of the country’s healthcare services.”  Dr. Hemantha Beneragama, Ministry of Health, Nutrition and Indigenous Medicine – Sri Lanka added, “This global alliance with the top pathology laboratories will help in strengthening our relationships with the neighboring nations.  Leveraging the expertise of world-class pathology brands, we look forward to leveling the existing gaps in our healthcare system.” ]]> <![CDATA[Lupin acquires Symbiomix Therapeutics LLC]]> https://biospectrumindia.com/news/95/9644/lupin-acquires-symbiomix-therapeutics-llc.html https://biospectrumindia.com/news/95/9644/lupin-acquires-symbiomix-therapeutics-llc.html Wed, 11 Oct 2017 14:55:00 +0530 Pharma major Lupin has announced that its US subsidiary, Lupin, Inc., has acquired Symbiomix Therapeutics, LLC. Symbiomix is a privately held company focused on bringing innovative therapies to market for gynecologic infections that can have serious health consequences. The acquisition has been made for a cash consideration of USD 150 million including a USD 50 million upfront and other time-based payments. In addition, there are sales based contingent payments. The acquisition is funded from internal funds. The acquisition of Symbiomix and the Solosec franchise significantly expands Lupin’s branded women’s health specialty business, which is presently anchored by Methergine (methylergonovine) tablets. SOLOSEC (secnidazole) 2g oral granules is a 5-nitroimidazole antimicrobial agent indicated for the treatment of bacterial vaginosis in adult women On September 15, 2017, the US FDA approved Symbiomix’s lead product, Solosec (secnidazole) oral granules, for the treatment of bacterial vaginosis (BV) in adult women. Lupin’s Solosec will be commercially available by mid-2018. Solosec has been designated as a Qualified Infectious Disease Product (QIDP) by the U.S. Food and Drug Administration (FDA) for the treatment of BV. QIDP designation is for medications intended to treat serious or life-threatening infections and makes Solosec eligible for at least 10 years of exclusivity in the United States. The FDA approval of Solosec was supported by a comprehensive set of studies, including two pivotal trials in BV and an open label safety study, which demonstrated efficacy for single-dose Solosec 2g. Solosec is the first and only single dose oral treatment approved for BV, the most prevalent gynecologic infection in the U.S., affecting 21 million women ages 14 to 49 annually. Vinita Gupta, CEO of Lupin said, “We are delighted to complete the acquisition of Symbiomix and its Solosec™ brand, which immediately expands Lupin’s US women’s health specialty business into the highly-complementary gynecological infection sector.” “This transaction is an important milestone in the evolution of our Specialty business and gives Lupin a new therapeutic to bring to obstetricians and gynecologists to treat a serious health condition they see frequently in their practices”, she added.   ]]> <![CDATA[Lupin receives FDA approval for generic Corgard Tablets]]> https://biospectrumindia.com/news/95/9640/lupin-receives-fda-approval-for-generic-corgard-tablets.html https://biospectrumindia.com/news/95/9640/lupin-receives-fda-approval-for-generic-corgard-tablets.html Tue, 10 Oct 2017 17:10:00 +0530 Pharma Major Lupin has announced that it has received final approval for its Nadolol Tablets USP, 20 mg, 40 mg, and 80 mg from the United States Food and Drug Administration (FDA) to market a generic version of US WorldMeds, LLC’s Corgard Tablets, 20 mg, 40 mg, and 80 mg. Lupin’s Nadolol Tablets USP, 20 mg, 40 mg, and 80 mg are the AB rated generic equivalent of US WorldMeds, LLC’s Corgard Tablets, 20 mg, 40 mg, and 80 mg. They are indicated for management of patients with angina pectoris and for the treatment of hypertension. Nadolol Tablets USP, 20 mg, 40 mg, and 80 mg Tablets had annual sales of approximately USD 109.8 million in the US (IMS MAT June 2017). ]]> <![CDATA[Piramal announces large scale expansion of API manufacturing facilities]]> https://biospectrumindia.com/news/95/9637/piramal-announces-large-scale-expansion-of-api-manufacturing-facilities.html https://biospectrumindia.com/news/95/9637/piramal-announces-large-scale-expansion-of-api-manufacturing-facilities.html Tue, 10 Oct 2017 12:30:00 +0530 Piramal Pharma Solutions (PPS) which is a leading Contract Development and Manufacturing Organisation (CDMO) and part of Piramal Enterprises Ltd. (PEL) has announced investments of $55 million across its sites in North America & Asia, to expand its API manufacturing capabilities and capacities. A part of this investment will go into new state-of-the-art, multi-purpose plants, with over 270kL of total capacity, to support the current pipeline of approximately 80 late stage programs that PPS is currently assisting its partners with at various global sites. PPS will also expand its potency footprint at its plant in Riverview, Michigan, while augmenting early development capabilities out of Ennore, India through additions of GMP kilo labs and a pilot plant. It will also add early development capabilities in both, drug substance and drug product, out of its Morpeth, UK facility. Support functions such as Analytical capabilities, R&D infrastructure, automation, and IT systems will also be expanded at all API sites through this investment. Vivek Sharma, CEO, Piramal Pharma Solutions said, “We are committed towards investing in our customers future needs. With these investments, we can now support the commercialisation of our pipeline of over 80 programs that are at Phase II or beyond, while allowing us additional capacity for future partnerships." “There has been significant customer interest in our ‘integrated’ offerings, and we are pleased to have over 60 integrated programs at PPS across all phases of drug development.  We thank our customers for their trust and support and promise to continue the focus on the three pillars that made us their Partner of Choice: Customer Centricity, Quality, and Innovation”, he also added.       ]]> <![CDATA[Intas Pharma slashes cancer drug prices]]> https://biospectrumindia.com/news/95/9624/intas-pharma-slashes-cancer-drug-prices.html https://biospectrumindia.com/news/95/9624/intas-pharma-slashes-cancer-drug-prices.html Fri, 06 Oct 2017 10:50:00 +0530 Intas Pharmaceuticals Ltd has announced that it will cut down the prices of Bevacizumab drug by 60 per cent. The company states that it will bring relief to a large number of cancer patients in India for whom the drug was out of reach until now. The Intas Pharma therapy is now priced at Rs. 39,995 for the dose strength of 400 mg variant, which makes it 60 per cent less than the currently available options worth about Rs. one lakh. Every year over 7 lakh patients die due to various types of cancer in India. Bevacizumab slows down the growth of new blood vessels and is used in treating multiple cancers like colorectal, ovarian, cervical, lung and recurrent glioblastoma (a type of brain tumour). The drug has been available in India since 2004 but the cost was prohibitive to most patients. Intas Pharma has been growing at a 27 per cent CAGR over the last 5 years with an even stronger profit growth. Ranked No. 10 in the domestic market, the company is one of the top five in the Indian chronic therapy category. The company is also present in more than 70 countries worldwide in markets like North America, Europe, Central and Latin America, Africa, Australia, New Zealand, Asia-Pacific as well as CIS and MENA countries. ]]> <![CDATA[FDA approves generic Acticlate Tablets by Lupin]]> https://biospectrumindia.com/news/95/9618/fda-approves-generic-acticlate-tablets-by-lupin.html https://biospectrumindia.com/news/95/9618/fda-approves-generic-acticlate-tablets-by-lupin.html Wed, 04 Oct 2017 16:30:00 +0530 Lupin has recently announced the final approval for its Doxycycline Hyclate Tablets USP, 75 mg and 150 mg from the United States Food and Drug Administration (FDA) to market a generic version of Aqua Pharmaceuticals, LLC’s Acticlate Tablets, 75 mg and 150 mg. Lupin’s Doxycycline Hyclate Tablets USP, 75 mg and 150 mg are the AB rated generic equivalent of Aqua Pharmaceuticals, LLC’s Acticlate Tablets, 75 mg and 150 mg. They are indicated in the treatment of infections caused by various microorganisms and as an adjunctive therapy in severe acne. Doxycycline Hyclate Tablets USP, 75 mg and 150 mg had annual sales of approximately USD 263 million in the US (IMS MAT June 2017).   ]]> <![CDATA[Typhoid vaccine by Bharat Biotech shows efficacy]]> https://biospectrumindia.com/news/95/9611/typhoid-vaccine-by-bharat-biotech-shows-efficacy.html https://biospectrumindia.com/news/95/9611/typhoid-vaccine-by-bharat-biotech-shows-efficacy.html Tue, 03 Oct 2017 13:30:00 +0530 Vaccine Innovator Bharat Biotech has announced that its next generation typhoid vaccine, Typbar-TCV, has demonstrated its safety and efficacy in a high risk human challenge clinical study carried out at Oxford University. What is very significant is the clinical studies produced 87 per cent effectiveness as per the trial results published in Lancet. Published in The Lancet, the study is the first to demonstrate that immunization with Typbar-TCV is safe, well tolerated and will have significant impact on disease incidence in typhoid endemic areas that introduce the vaccine. This study was conducted in 112 adult volunteers and used a controlled human infection model. According the study published in Lancet vaccine is safe, 100 per cent immunogenic, and prevents up to 87 per cent of infections, when using real life definitions of typhoid fever. Efficacy data from this trial will help to fill a long existing knowledge gap regarding Vi-conjugate vaccines. This data is highly significant since the currently available vi-ps typhoid vaccines cannot be administered to children below 2 years, and do not confer long term immunity. Typbar-TCV can be administered to children below 2 years of age and does confer long term immunity. Protection over a longer term reduces the need for repeat vaccinations. Commenting on the Lancet published study and Typbar-TCV R&D milestone Dr. Krishna Ella Chairman & Managing Director said that the Company is pleased that the vaccine has been found to be extremely effective in the first ever high risk human challenge studies. “The results of this study and the 87 per cent effectiveness success endorse more than 10 years of R&D efforts to develop this vaccine and various clinical trials that have been carried out over the past 8 years”, he said. He also mentioned that the Company has built dedicated facilities for the manufacture of this vaccine. “Multidrug-resistant Salmonella typhi has become a major public health problem, as more people are prescribed antibiotics for even common fever in developing nations.” Dr. Ella stated citing the example of drug resistance against typhoid fever found in Hyderabad city in Pakistan. We are proud being world-first to pursue a high risk human challenge study and be successful. This paves way for an early realisation of an effective vaccine that can help reduce the typhoid fever disease burden faced by millions of families. Dr. Ella added. The trial led by Prof. Andrew Pollard, Director, Oxford Vaccine Group, was designed based on human infection models where many of the participants, mostly University students, were to consume a drink containing bacteria.The results of the trial clearly show that the new Typhoid Conjugate vaccine gives significantly superior performance compared to the Typhoid Vi polysaccharide vaccine. It is unconscionable that children are still dying by the thousands every year from diseases like typhoid that are completely preventable," said Anita Zaidi, director of the Enteric and Diarrheal Diseases team at the Bill & Melinda Gates Foundation. "The prevention and control of typhoid should be a global health priority and we are pleased to support the Typhoid Vaccine Acceleration Consortium as part of our overall strategy to combat typhoid through an integrated approach including access to clean water, improved sanitation, and immunization." The Typbar TCV conjugated to tetanus toxoid vaccine human challenge study holds great promise particularly in of south Asia and sub-Saharan Africa which have a high burden of typhoid fever including incidence of multi drug resistance challenge that cities like Hyderabad in Pakistan and Bangladesh are aiming to tackle currently. Bharat Biotech is working with the Consortium in carrying out field trials in different countries to evaluate the efficacy of TypbarTCV. Typhoid is caused by the bacterium Salmonella Typhi, and is responsible for around 20 million new infections and 200,000 deaths each year, mainly in South and South East Asia and Africa. Although typhoid as a disease is amenable to antibiotics treatment, increasing frequencies of multi-drug resistance among the invasive isolates is posing a serious threat and limiting the effectiveness of such treatments. The Product Summary File has been submitted to World Health Organisation for prequalification. WHO prequalification would allow for UNICEF to procure this vaccine for low-income countries where the disease burden is very high. TypbarTCV is currently licensed in India, Nigeria, and Nepal, with registrations underway in Malaysia, Turkey, Thailand, Uganda, Kenya, Bangladesh, Pakistan, Vietnam, etc among ~ 30 other countries.    ]]> <![CDATA[Hilleman Laboratories receives Indo-Swedish grant for developing - Oral Cholera Vaccine]]> https://biospectrumindia.com/news/95/9604/hilleman-laboratories-receives-indo-swedish-grant-for-developing-oral-cholera-vaccine.html https://biospectrumindia.com/news/95/9604/hilleman-laboratories-receives-indo-swedish-grant-for-developing-oral-cholera-vaccine.html Thu, 28 Sep 2017 15:30:00 +0530 Hilleman Laboratories, a joint-venture partnership between MSD and Wellcome Trust, received a 6 million krona (737281.80 US Dollar) Indo – Swedish grant for the project ‘Improved, affordable single strain whole cell-B subunit oral cholera vaccine’. The proposed project, carried out by Hilleman Laboratories, is being jointly funded by the Department of Biotechnology (DBT), Government of India and Vinnova, the Swedish Governmental Agency for Innovation Systems. The project will fuel further Research & Development of the Oral Cholera Vaccine (OCV) with knowledge exchange and transfer of scientists across India and Sweden. Speaking on the partnership, Dr Davinder Gill, CEO Hilleman Laboratories said, “Cholera remains a threat to global public health and is a barometer of health inequity and lack of social development. Considering the urgent need for effective and affordable Cholera vaccines, both for use in Cholera outbreaks and in mass vaccination campaigns, we would like to accelerate development of our simplified Oral Cholera Vaccine, HILLCHOLTM.” He added, “Our partnership with DBT and Vinnova is a step in a new direction. We are gratified by the grant awarded to us, which will help us develop capabilities through cross-border partnerships. We look forward to the teamwork required to fight a fatal disease like Cholera, and to come up with a safe and affordable vaccine against this disease.” Further, Dr Ajit Pal Singh, Vice President, Clinical R&D, Hilleman Laboratories added, “We are pleased to be appreciated by the Indo-Swedish governments, and the association with DBT and Vinnova to develop the Oral Cholera Vaccine (OCV), which is an important project for Hilleman Labs. The grant will incentivize advancement of Clinical R&D against diseases that disproportionately affect poor countries. It will allow us to invest in innovation more effectively to explore high-quality vaccines & technologies”. The OCV developed by Hilleman Labs would make mass vaccination a reality in Cholera endemic zones due to ease of manufacturing and low cost, thereby improving vaccine affordability and accessibility. Cholera continues to be a serious health problem and there is high prevalence of the diseases due to global conflict, natural disasters, poor sanitation and unsafe drinking water. Affordable and low-cost vaccines will help in reducing the burden of disease and contribute to Cholera control efforts. ]]> <![CDATA[Suven gets product patent from India and Japan]]> https://biospectrumindia.com/news/95/9585/suven-gets-product-patent-from-india-and-japan.html https://biospectrumindia.com/news/95/9585/suven-gets-product-patent-from-india-and-japan.html Tue, 26 Sep 2017 11:25:00 +0530 Drug firm Suven Life Sciences has been granted a patent each by India and Japan for a drug used in the treatment of neuro-degenerative diseases. Suven Life has been granted one product patent from India and one product patent from Japan corresponding to the New Chemical Entities (NCEs) for the treatment of disorders associated with neurodegenerative diseases. The patents are valid till 2027 and 2032, respectively. The granted claims of the patents are being developed as therapeutic agents and are useful in the treatment of cognitive impairment associated with neurodegenerative disorders like Alzheimer's disease, attention deficient hyperactivity disorder (ADHD), Huntington's disease, Parkinson's and Schizophrenia. The company is very pleased by the grant of these patents for the pipeline of molecules in CNS (central nervous system) arena that are being developed for cognitive disorders with high unmet medical need with huge market potential globally. ]]> <![CDATA[7th season on ‘Emerging Trends in Injectable Market’ organized by Becton Dickinson]]> https://biospectrumindia.com/news/95/9575/7th-season-on-emerging-trends-in-injectable-market-organized-by-becton-dickinson.html https://biospectrumindia.com/news/95/9575/7th-season-on-emerging-trends-in-injectable-market-organized-by-becton-dickinson.html Fri, 22 Sep 2017 14:35:00 +0530 Technovation which is an initiative of BD Medical-Pharmaceutical Systems to share global trends, new regulations, latest technologies in the healthcare and Pharma sector and advances in the pre-fillable drug delivery domain, organised its 7th season on ‘Emerging Trends in Injectable Market’ across three cities like Mumbai, Ahmedabad and Hyderabad. As more drugs are coming onto the market paired with pre-filled syringes as the delivery devices, one of the key highlights of the seminar was the latest trends in the global and emerging markets. Prefilled-syringes or injectable drug delivery system is an innovative approach that helps bring accuracy, safety, and convenience in conventional parenteral drug delivery. With pre-filled syringes emerging as one of the fastest-growing choices by doctors for unit dose medication and as more convenient drug delivery methods, the market of self-injection devices is estimated to grow at the rate of 16.1% during the forecast period of 2013 – 2018. This is more than double the expected growth rate of conventional injection devices, which is projected to be around 7.4%. The global injectable drug delivery devices market is also expected to increase from around 11.6 billion dollars in the year 2013 to 17.5 billion dollars in 2018. Prefilled syringes have the advantages over parenteral drug delivery because of convenience, accuracy, sterility, and safety, and they not only minimize drug waste but also helps patients to self-administer injectable drugs at their home. The seminar included sessions by eminent experts from the industry who shared their views on emerging trends in injectable drug delivery market in India, system integration approach, evolving regulatory procedures in the country and technical services support. Sharing the perspective of pharmaceutical companies, Christian Herget, Global Business Director said, “In chronic diseases, self-administration of drugs by patients is very common, therefore along with cost, it is important to ensure patient convenience and safety. Such platforms, that bring stakeholders from across healthcare delivery spectrum, facilitate a bilateral exchange of ideas and helps manufacturers understand the finer nuances of the drug delivery system and patient’s concerns. While the focus of drug manufacturing companies has always been on the efficacy and safety of the product, with more exposure to first-hand reviews, the manufacturers are becoming more careful in designing integrated drug delivery systems in terms of their function and efficacy.” With Asia taking more than 60% of the business volume, experts extensively discussed the double-digit growth of global pharma industry where customers, patients, and care givers are constantly seeking newer solutions. Pharma industry is one of the major contributors to Indian economy, and therefore to safeguard the interest of patients as well as investors, it is important that private-public partnerships evolve with the changing ecosystem while keeping focus intact on regulations, safety, and public interest. Herget also added, “The biologics market is not only outpacing the small molecules in terms of revenues bust is also entering new therapy areas like cardiovascular and respiratory disorders and chronic pain.”  Kirat Majmudar, Business Director- BD Medical – Pharmaceutical Systems added, “BD has been prudent to respond to evolving market needs and provide great value to customers. Technovation offered the perfect platform for a constructive dialogue between experts, customers and paved way for a compelling business opportunity in the future. In an environment that is ever evolving, we will continue to engage with our customers more in-depth and drive shared success.” BD Medical - Pharmaceutical Systems has been conducting Technovation - a fast-growing knowledge sharing platform since 2010, where they invite subject matter experts to exchange their knowledge to partner for shared success.   ]]> <![CDATA[Indian Oil and Lanza Tech to construct world’s first refinery off Gas-to-Bioethanol Production ]]> https://biospectrumindia.com/news/95/9570/indian-oil-and-lanza-tech-to-construct-worlds-first-refinery-off-gas-to-bioethanol-production-.html https://biospectrumindia.com/news/95/9570/indian-oil-and-lanza-tech-to-construct-worlds-first-refinery-off-gas-to-bioethanol-production-.html Thu, 21 Sep 2017 14:30:00 +0530 Indian Oil Corporation Limited ( Indian Oil), India’s flagship national oil company and, LanzaTech, carbon recycling company, have signed a Statement of Intent to construct the world’s first refinery off gas-to-bioethanol production facility in India. LanzaTech has developed a gas fermentation process to make fuels and chemicals. Instead of sugars and yeast, the company uses a biological catalyst to ferment waste gas emissions. The large volume of waste gas produced at industrial facilities such as refineries cannot be stored or transported; rather it must be combusted to make power locally and emitted as carbon dioxide (CO2). Power can be carbon-free, and in India today, the cost of renewable power has fallen below the cost of coal, accelerating the transition to a carbon-free grid. LanzaTech’s technology allows refineries to divert waste gases from the grid, supporting the transition to fully renewable power while recycling this carbon into liquid fuels and petrochemicals. India is adopting a cleaner and greener economic growth pathway, with the Government running one of the largest renewable capacity expansion programmes in the world. The implementation of the National Smart Grid Mission, along with new programmes for increasing energy capacities from wind and waste conversion, are key elements of this vision. This vision is inextricably linked to the principle of ‘need-based consumption’ which follows the need to maximize on existing resources and decarbonise everyday activities. For liquid fuels, this is highlighted by targets initiated by the Ministry of Petroleum & Natural Gas to increase the supply of ethanol-blended petrol (E10) to all parts of the country.   Indian Oil is aligned with this Ministerial vision and is working to both reduce its overall emissions and to improve refinery yields.  For this reason,  Indian Oil has selected the LanzaTech technology which enables the beneficial reuse of carbon-rich off-gases for the production of ethanol. The ethanol produced from the recycling of refinery off-gases is expected to have a greenhouse gas emissions savings of over 70 percent compared to conventional gasoline. The basic engineering for the 40 million litres (35K MTA) per annum demonstration facility will begin later this year for installation at  Indian Oil’s Panipat Refinery in Haryana, India, at an estimated cost of 350 crore rupees (USD 55 million). It will be integrated into existing site infrastructure and will be LanzaTech’s first project capturing refinery off-gases. LanzaTech’s first commercial facility converting waste emissions from steel production to ethanol will come online in China in late 2017. “India is on track to exceed its Paris commitments,” said India’s Minister of Petroleum and Natural Gas, Dharmendra Pradhan. “This is thanks to investment in novel low-carbon technologies such as this project between  Indian Oil and LanzaTech. It is promising to see carbon turned from a liability into an opportunity, where we can reduce emissions, maximise resources and decarbonise our economy.” ]]> <![CDATA[Lupin appoints Jim Loerop as Chief Corporate Development Officer]]> https://biospectrumindia.com/news/95/9558/lupin-appoints-jim-loerop-as-chief-corporate-development-officer.html https://biospectrumindia.com/news/95/9558/lupin-appoints-jim-loerop-as-chief-corporate-development-officer.html Wed, 20 Sep 2017 16:05:00 +0530 Pharma major Lupin has appointment Jim Loerop as its new Chief Corporate Development Officer. Jim will lead Lupin’s overall corporate development efforts and will be responsible for the company’s global M&A and business development functions. He will integrate Lupin’s Business development, Licensing and M&A teams to drive the company’s global M&A and Business Development strategy. A seasoned professional with over 27 years of experience in the pharmaceutical industry, Jim joins Lupin from Alexion Pharmaceuticals, Inc. where he served as Senior Vice President of Global Business Development. Prior to Alexion, he held multiple leadership positions at leading pharmaceutical companies such as GlaxoSmithKline, Stiefel (a GSK Company), KV Pharmaceutical and Curatek Pharmaceuticals. Jim graduated from Western Michigan University with a major in Marketing following which he began his career as a Sales Representative with Solvay Pharmaceuticals. Commenting on the appointment, Vinita Gupta, Chief Executive Officer, Lupin said, “We are delighted to welcome Jim at a crucial time as we accelerate our transition into complex generics and specialty brand segments. Jim’s rich experience in both branded and generic business will be invaluable in helping us navigate our business towards new growth opportunities.”  Jim will be based in Naples, Florida in the US, and he will report to Vinita Gupta, CEO, Lupin. ]]> <![CDATA[Nacimbio signs agreement with MYLAN Laboratories]]> https://biospectrumindia.com/news/95/9552/nacimbio-signs-agreement-with-mylan-laboratories.html https://biospectrumindia.com/news/95/9552/nacimbio-signs-agreement-with-mylan-laboratories.html Tue, 19 Sep 2017 16:15:00 +0530 The National Immunobiological Company (Nacimbio) which is a part of Rostec State Corporation has signed an agreement with Mylan Laboratories limited on the transfer of technology for the production of ready-made dosage forms and active pharmaceutical substances. The agreement was signed at Biotechmed-2017 recently held in Gelendzhik. It is organised with the support of the Ministry of Health of the Russian Federation, the Ministry of Industry and Trade of the Russian Federation and the Ministry of Agriculture of the Russian Federation. The strategic partner of the conference is Rostec State Corporation. Within the framework of the license agreement, there will be transfer of technology for the production of both ready-made forms and active pharmaceutical substances for the creation of modern combined drugs for the treatment of HIV infection. At "Biotechmed-2017" conference Sergei Chemezov, CEO, Rostec said, “The Corporation's activities are aimed at reducing dependence on imported medicines. At the same time, the corporation is ready for a technological partnership in the pharmaceutical industry. "We are developing our own drug production, jointly with well-known foreign pharmaceutical companies, who are ready to localize production of their products in Russia.” "We are starting cooperation with India's MYLAN LABORATORIES LIMITED. This will provide us with the supply of substances, transfer of technology and the creation of modern combination drugs for HIV treatment. As a result, their cost in the Russian market will significantly decrease”, he added.  Currently, Nacimbio supplies domestic vaccines under state contracts with the Ministry of Health, which are included in the national calendar of preventive vaccinations. In total, 17 items of vaccines are supplied, of which 14 are completely Russian-made.   ]]> <![CDATA[Biocon’s First Overseas Insulin Unit in Malaysia receives EU GMP Compliance]]> https://biospectrumindia.com/news/95/9542/biocons-first-overseas-insulin-unit-in-malaysia-receives-eu-gmp-compliance.html https://biospectrumindia.com/news/95/9542/biocons-first-overseas-insulin-unit-in-malaysia-receives-eu-gmp-compliance.html Mon, 18 Sep 2017 11:40:00 +0530 Biocon Ltd. has received a compliance certificate from the Irish drug regulator for its manufacturing and research facility in Malaysia. Biocon Sdn. Bhd., its Malaysian subsidiary was issued a certificate of Good Manufacturing Practices Compliance, for its insulin manufacturing unit, said a stock exchange filing by Biocon. The facility has been inspected by the European Medicine Agency in April. “Biocon’s subsidiary in Malaysia, Biocon Sdn. Bhd., has been issued a Certificate of ‘GMP Compliance’ for its Insulins manufacturing facility by the HPRA (Ireland) as the representative European inspection authority,” Biocon told BSE. The certificate reflects that EMA considers the site to be GMP-compliant for active substances, sterile drug products, and quality control testing operations, it added.  Biocon's Malaysia facility was inspected by the EMA in April 2017, stated the company. This Biocon’s first overseas biopharma manufacturing and research facility was set up with an investment of $275 million and employs more than 600 professionals. It has been designed to manufacture human insulin for the treatment of diabetes. Biocon has been developing a fast-acting oral insulin drug for a rarer case of diabetes Type 1, whose causes and preventive measures are yet not known. It has also filed an application with Drug Controller General of India for running clinical trials for a drug catering the more common type 2 diabetes. Insugen and Basalog are the already selling insulin brands of Biocon's Biologics division, that contributes nearly 19percent to its total revenue. ]]> <![CDATA[Lupin receives FDA approval for generic Flagyl & Vibra-Tabs tablets]]> https://biospectrumindia.com/news/95/9532/lupin-receives-fda-approval-for-generic-flagyl-vibra-tabs-tablets.html https://biospectrumindia.com/news/95/9532/lupin-receives-fda-approval-for-generic-flagyl-vibra-tabs-tablets.html Thu, 14 Sep 2017 10:40:00 +0530 Pharma Major Lupin announced that it has received final approval for its Metronidazole Tablets USP, 250 mg and 500 mg and Doxycycline Hyclate Tablet USP, 100 mg from the United States Food and Drug Administration (FDA) to market a generic version of G.D. Searle LLC’s Flagyl Tablets, 250 mg and 500 mg and Pfizer Inc.’s Vibra-Tabs 100 mg respectively. Lupin’s Metronidazole Tablets USP, 250 mg and 500 mg are the AB rated generic equivalent of G.D. Searle LLC’s Flagyl Tablets, 250 mg and 500 mg and indicated in the treatment of wide variety of infections which are caused by particular types of bacteria and other infectious organisms. Doxycycline Hyclate Tablet USP, 100 mg is the AB rated generic equivalent of Pfizer Inc.’s Vibra-Tabs 100 mg. It is indicated in the treatment of infections caused by various microorganisms and as an adjunctive therapy in severe acne. Flagyl Tablets had US sales of USD 44.1 million (IMS MAT June 2017) and Doxycycline Hyclate Tablet USP, 100 mg had US sales of USD 149.9 million (IMS MAT June 2017).   ]]> <![CDATA[MSD announces entry of Keytruda in India]]> https://biospectrumindia.com/news/95/9529/msd-announces-entry-of-keytruda-in-india.html https://biospectrumindia.com/news/95/9529/msd-announces-entry-of-keytruda-in-india.html Wed, 13 Sep 2017 11:40:00 +0530 US biopharmaceutical giant Merck, Sharpe and Dohme (MSD) has launched its blockbuster cancer drug ‘Keytruda’ (pembrolizumab) in India around a year after it first received approvals to market it. The drug has so far only been approved here for a less prevalent type of cancer, while it is marketed in countries like the US to treat additional indications like a specific kind of lung cancer. Keytruda, hailed as a ‘gamechanger’ therapy in oncology, is expected to help the immune system identify and selectively combat only cancerous cells instead of aggressively attacking cancer cells and risking healthy tissues in the process like existing therapies. The drug generated global sales of $1.4 billion during 2016. The Drug Controller General of India (DCGI) gave MSD permission to market Keytruda in June 2016. Keytruda is expected to be 30 per cent cheaper than the global prices and cost Rs 3.75-4.5 lakh for each dose. The drug was launched in the US in 2014 at a price of reportedly $12,500 for each patient monthly or $150,000 annually. Oncologists expect MSD to approach the apex drug regulator to extend its approval for Keytruda to additional indications, including Non- Small Cell Lung Cancer, now that it has launched the product here.   ]]> <![CDATA[Aurigene announces initiation of CA-170 phase 2 trial]]> https://biospectrumindia.com/news/95/9527/aurigene-announces-initiation-of-ca-170-phase-2-trial.html https://biospectrumindia.com/news/95/9527/aurigene-announces-initiation-of-ca-170-phase-2-trial.html Wed, 13 Sep 2017 11:25:00 +0530 Aurigene Discovery Technologies Limited, a wholly owned subsidiary of Dr. Reddy’s Laboratories Ltd. and a specialized biotechnology company engaged in discovery and early clinical development of novel and best-in-class therapies to treat cancer and inflammatory diseases, announced plans to initiate a Phase 2 trial of CA-170, a PDL1-VISTA inhibitor to be conducted at sites in India. This was announced following the presentation of preliminary data from the initial 34 patients with cancer treated in the dose escalation stage of the Phase 1 trial of CA-170 at the European Society for Medical Oncology (ESMO) 2017 Congress by Aurigene’s collaborator and licensee of CA-170, Curis, Inc., a biotechnology company focused on the development and commercialization of innovative and effective therapeutics for the treatment of cancer. The trial has been conducted in the U.S., South Korea and Spain. The Phase 2 trial is the result of the initial safety data and preliminary evidence of clinical benefit observed in the trial. CA-170 is an oral small molecule targeting the immune checkpoints PDL1 and VISTA. Data presented at the ESMO 2017 conference represent the initial 34 patients treated to date in the dose escalation Phase 1 trial. 30 patients were naïve to prior immunotherapy treatment, while four patients had experienced prior treatment with approved anti-checkpoint antibodies. No dose limiting toxicities were observed at doses ranging from 50 mg to 800 mg once daily dosing examined thus far. CA-170 demonstrated good oral bioavailability and plasma drug levels were shown to increase in a near-linear manner with increasing doses. Evidence of immune modulation, including an increase in activated CD8+ T cells, was observed in patient blood and tumor biopsy samples examined following treatment. Of the 21 patients evaluable for disease assessment, 13 patients experienced disease stabilization. Four immunotherapy treatment-naïve patients treated with CA-170 experienced shrinkage of their tumors. Six patients remained on drug treatment beyond three months, including all four patients with tumor shrinkages. In addition, seven of the 34 patients remain on study and are continuing with treatment. “These results are consistent with the observations made in the preclinical setting and further affirm CA-170’s mechanism of action as an oral small molecule checkpoint inhibitor. Based on these initial clinical results, we are excited for the opportunity to expand testing of CA-170, possibly in earlier lines of treatment and in a greater number of immunotherapy treatment-naïve cancer patients,” commented Mr. CSN Murthy, Chief Executive Officer of Aurigene. “Together with Curis, we have designed a Phase 2 trial, treating selected populations of patients of interest in the CA-170 program to be treated at major cancer centers in India. Aurigene’s decision to sponsor and fund this trial is further affirmation of our commitment to CA-170 and a reflection of the successful collaboration we have with Curis in multiple development programs. Aurigene has the commercial rights to the program in India and Russia in addition to milestones, royalties other commercial supply rights globally.” “We are pleased with these early results. Evidence of tumor shrinkage and multiple patients remaining on drug treatment for extended periods, along with signals for biomarkers of immune modulation in patient blood and tumor samples, tells us the program continues to move in the right direction. We plan to continue with the dose escalation and continued analysis of patient biopsy samples in the Phase 1 trial,” said Ali Fattaey, Ph.D., President and Chief Executive Officer of Curis. “We expect to provide additional updates at upcoming conferences including the Society for Immunotherapy of Cancer (SITC) annual meeting in November.” “The ability for cancer patients to administer a potential checkpoint inhibitor on their own as a once daily oral drug is a significant and unique opportunity in our field,” added Adil Daud, M.D., investigator in the CA-170 Phase 1 trial and director of Melanoma Clinical Research at the UCSF Helen Diller Family Comprehensive Cancer Center. “These initial clinical results are encouraging and merit continued development.” ]]> <![CDATA[Kidney stone drug from Strides Shasun receives USFDA approval ]]> https://biospectrumindia.com/news/95/9525/kidney-stone-drug-from-strides-shasun-receives-usfda-approval-.html https://biospectrumindia.com/news/95/9525/kidney-stone-drug-from-strides-shasun-receives-usfda-approval-.html Tue, 12 Sep 2017 16:25:00 +0530 Strides Shasun Limited has received approval from the United States Food & Drug Administration (USFDA) for Potassium Citrate Extended-Release Tablets USP, 5 mEq, 10 mEq, and 15 mEq According to IMS data, the US market for Potassium Citrate is approximately USD 110 Million.  Strides Shasun will be the second generic player to commercialize the product. The product, which is the first approval for an Extended Release tablet for the Company, will be launched immediately. Potassium Citrate, a urinary alkalinizing agent, is used for preventing certain types of kidney stones.  It works by neutralizing some of the acid in the urine, which helps reduce the formation of crystals Extended release pill is formulated in such a way that the drug is released slowly over time. This has the advantage of taking pills less often and fewer side effects, as the levels of the drug in the body are more consistent. Strides Shasun is a vertically integrated global pharmaceutical Company headquartered in Bangalore.  The Company has four business verticals, viz., Regulated Markets, Emerging Markets, Institutional Business and Active Pharmaceutical Ingredients. The Company has global manufacturing foot print with 9 manufacturing facilities spread across three continents including 7 US FDA approved facilities and 2 facilities for the emerging markets. The Company has two dedicated R&D facilities in India with global filing capabilities and a strong commercial footprint across 100 countries. ]]> <![CDATA[Teva Pharma strikes $1.1 B deal for Paragard]]> https://biospectrumindia.com/news/95/9522/teva-pharma-strikes-1-1-b-deal-for-paragard.html https://biospectrumindia.com/news/95/9522/teva-pharma-strikes-1-1-b-deal-for-paragard.html Tue, 12 Sep 2017 11:40:00 +0530 Teva Pharmaceutical Industries has agreed to sell its contraceptive brand Paragard to a unit of Cooper Cos for $1.1 billion, on a day the struggling Israeli drugmaker named industry veteran Kare Schultz as CEO. The company's U.S. listed shares were up 1.4 per cent at $18.75 in extended trading after closing up 19.3 percent in regular trading. The sale of the business is the first step in the planned divestment of non-core assets and the proceeds would be used to repay term loan debt. Saddled with about $35 billion in debt, Teva has speeded up plans to divest non-core assets. The company continues to look for divestiture opportunities, including the sale of the remaining assets of its global women's health business, as well as its oncology and pain businesses in Europe. Teva expects to generate at least $2 billion in total proceeds from the sale of these businesses, as well as additional asset sales to be executed by the end of 2017. The deal with Cooper includes Teva's manufacturing facility in Buffalo, NY, which makes Paragard exclusively. Paragard, an intrauterine copper contraceptive device, posted revenue of about $168 million for the year ended June 30. Teva will continue to manufacture and sell Paragard in the United States, until the deal is completed, which is expected before the year end. ]]> <![CDATA[AstraZeneca’s Global Medicines Development group set to expand in Bangalore]]> https://biospectrumindia.com/news/95/9518/astrazenecas-global-medicines-development-group-set-to-expand-in-bangalore.html https://biospectrumindia.com/news/95/9518/astrazenecas-global-medicines-development-group-set-to-expand-in-bangalore.html Mon, 11 Sep 2017 18:00:00 +0530 AstraZeneca’s Global Medicines Development group is building up its hub in Bangalore and recruiting physicians, scientists and regulatory experts as part of plans to support global management of established medicines for its growing portfolio which cover treatments across a range of therapy areas, including oncology, respiratory and cardiovascular and metabolic diseases. The company currently employs around 30 experienced physicians and scientists in Bangalore who are engaged in pharmacovigilance activities which support the monitoring of its medicines on the market around the world, and ensure continued safe use for patients. The intent is to expand that team, and to also add regulatory roles and other physician roles to support global management of established medicines. New offices are being set up for the expanding team in Bangalore. Recruitment is now underway and AstraZeneca is working with experienced recruitment partners to support the search for individuals with the right competence, and in the ambition of completing recruitment by end 2018. This latest expansion forms part of a broader plan in the Global Medicines Development (GMD) group to transform exciting new science and the company’s rich pipeline into more life-changing medicines for patients. Veena Rajan, Head of Patient Safety, Bangalore within the Global Regulatory, Patient Safety and Quality Assurance group, said: “We are already fortunate to have very talented people working with us in Bangalore, and we are looking to grow that team to build on the excellent work they are delivering in support of our late-stage and mature product portfolio.  As we all know, the Bangalore region, including Mumbai & Chennai, is an expanding area for the pharma industry, including several medical and biopharmaceutical companies, and there are many people here who are furthering their medical education. We aim to benefit from being part of this growing infrastructure and expand on the activities we are already successfully delivering from this location.” ]]> <![CDATA[Sanofi launches ‘Combiflam ICYHOT Pain Relief Topical in India]]> https://biospectrumindia.com/news/95/9516/sanofi-launches-combiflam-icyhot-pain-relief-topical-in-india.html https://biospectrumindia.com/news/95/9516/sanofi-launches-combiflam-icyhot-pain-relief-topical-in-india.html Mon, 11 Sep 2017 14:10:00 +0530 Sanofi India Limited expands its consumer healthcare portfolio with a new addition in the pain-care segment - Combiflam ICYHOT, a topical analgesic. The product is available in two formats – gel and spray, for instant and long-lasting relief to people suffering from muscle pains and sprains. Dr. Shailesh Ayyangar, Managing Director - India and Vice President - South Asia, Sanofi, said, “For over 30 years, people across India have trusted and relied on Sanofi’s products for pain relief. In fact, Combiflam is one of our flagship prescription brands and is present in 1 of 3 Indian households. Building on this legacy, the launch of Combiflam ICYHOT gel and spray in the over-the-counter (OTC) segment further expand our consumer healthcare portfolio.”  In a survey conducted by IPSOS in India, every person admitted to suffering from some kind of a pain in the last 12 months, but only 43 per cent of the pain occasions were treated with an available painkiller at home. Nikhilesh Kalra, General Manager – Consumer Healthcare, India & South Asia said, “Typically, people choose the format of their painkiller depending on the type of pain they are suffering from. When it comes to seeking relief from muscular pains including neck, shoulder and back pain, topicals are the most preferred format. To address this gap in our pain segment, we have brought the ICYHOT brand from Sanofi USA, and are manufacturing it indigenously to offer our Indian consumers a high-quality over-the-counter product, at affordable prices.” Combiflam ICYHOT gel is available in packs of 15g and 30g and priced at Rs.50 and Rs.98 respectively. The spray is available in packs of 35g and 55g and priced at Rs.115 and Rs.175 respectively. ]]> <![CDATA[Cadila Healthcare’s Moraiya facility successfully completes USFDA inspection ]]> https://biospectrumindia.com/news/95/9515/cadila-healthcares-moraiya-facility-successfully-completes-usfda-inspection-.html https://biospectrumindia.com/news/95/9515/cadila-healthcares-moraiya-facility-successfully-completes-usfda-inspection-.html Mon, 11 Sep 2017 12:00:00 +0530 Cadila Healthcare Limited has recently announced that the USFDA inspected its Moraiya facility from 31st August 2017 to 7th September, 2017. At the end of the inspection, no observation (483) is issued. The company has also received the final approval from the USFDA to market Mycophenolate Mofetil for Injection USP, 500 mg/vial. This drug is indicated for use in combination with other drugs i.e., cyclosporine and corticosteroids for the prophylaxis of organ rejection in patients receiving renal, hepatic or cardiac transplants. The drug will be manufactured at the group’s formulations manufacturing facility at Moraiya, Ahmedabad. The group now has more than 140 approvals and has so far filed over 300 ANDAs since the commencement of the filing process in FY 2003-04.   ]]> <![CDATA[Save the Children and Nokia deploy technology to make Govt. schemes more accessible ]]> https://biospectrumindia.com/news/95/9505/save-the-children-and-nokia-deploy-technology-to-make-govt-schemes-more-accessible-.html https://biospectrumindia.com/news/95/9505/save-the-children-and-nokia-deploy-technology-to-make-govt-schemes-more-accessible-.html Thu, 07 Sep 2017 17:30:00 +0530 Haqdarshak, launched on 31st August 2017, at the District Magistrate’s Office in South-East Delhi, is a Social Protection Application which aims to connect 50 communities in slums across South-East Delhi with various Government Schemes. This mobile application would enable any citizen to know about their eligibility to various government and private sector schemes through a simple one-time screening process. “We are happy that Save the Children and Nokia are initiating this in our district, and we hope that the initiative will enable the most vulnerable in Delhi to access social schemes more easily,” said Sh. B. S. Jaglan, District Magistrate, who heads the entire district (South-East Delhi), and has under him, Tehsildars, plays a vital role in providing certificates and documents in the jurisdiction of 25 communities. Developed by Save the Children for its Nokia-supported programme on building the resilience of communities by using technological solutions, the application is part a programme on building resilience amongst communities and children across 5 disaster-prone States of India, i.e, Andhra Pradesh, Bihar, Delhi, Rajasthan and Tamil Nadu. This is being done by strengthening access to social protection schemes with the use of technology in 350 most vulnerable villages and slums. “The long-term aim of this initiative is to ‘facilitate’ access to the schemes to the most vulnerable individuals and families, along with creating sensitivity amongst stakeholders, around the child-centered schemes and services as a part of our work on building resilience of communities by using technological solution,” said Thomas Chandy, CEO, Save the Children India.  The Haqdarshak model based on mobile and a desktop-based platform is aimed at digitizing the schemes and enabling citizens to apply for their rightful entitlements. The app has been created by Haqdarshak Empowerment Solutions Private Limited for a pilot in Delhi. “Nokia believes that technology should also be used for creating and strengthening structures to make cities resilient”, said  Amit Marwah, Head-India Marketing and Corporate Affairs and member CSR Working Committee Nokia. ]]> <![CDATA[Zydus receives final approval for Mycophenolate Mofetil Injection & Donepezil Hydrochloride Tablets]]> https://biospectrumindia.com/news/95/9498/zydus-receives-final-approval-for-mycophenolate-mofetil-injection-donepezil-hydrochloride-tablets.html https://biospectrumindia.com/news/95/9498/zydus-receives-final-approval-for-mycophenolate-mofetil-injection-donepezil-hydrochloride-tablets.html Wed, 06 Sep 2017 14:35:00 +0530 Zydus Cadila has received the final approval from the USFDA to market Mycophenolate Mofetil for Injection USP, 500 mg/vial indicated for use in combination with other drugs i.e., cyclosporine and corticosteroids for the prophylaxis of organ rejection in patients receiving renal, hepatic or cardiac transplants. It has also received an approval to market Donepezil Hydrochloride Tablets, in the strength of 23 mg. The drug is indicated for the treatment of dementia of the Alzheimer’s disease. Both the drugs will be manufactured at the group’s formulations manufacturing facility at Moraiya, Ahmedabad. ]]> <![CDATA[Dr. Reddy's launches antidepressants in the US market]]> https://biospectrumindia.com/news/95/9499/dr-reddys-launches-antidepressants-in-the-us-market.html https://biospectrumindia.com/news/95/9499/dr-reddys-launches-antidepressants-in-the-us-market.html Wed, 06 Sep 2017 14:30:00 +0530 Dr. Reddy’s Laboratories Ltd. has launched Bupropion Hydrochloride Extended-Release Tablets, USP (XL), 150 mg and 300 mg, a therapeutic equivalent generic version of Wellbutrin XL (Bupropion Hydrochloride Extended-Release) Tablets, approved by the U.S. Food & Drug Administration (USFDA).  Bupropion Hydrochloride Extended-Release Tablets , an antidepressant of the aminoketone class, is chemically unrelated to tricyclic, tetracyclic, selective serotonin re-uptake inhibitor, or other known antidepressant agents. Its structure closely resembles that of diethylpropion; it is related to phenylethylamines.  The Wellbutrin XL brand and generic had U.S. sales of approximately $754 million MAT for the most recent twelve months ending in July 2017 according to IMS Health. Dr. Reddy’s Bupropion Hydrochloride Extended-Release Tablets, USP (XL), 150 mg and 300 mg, are each available in bottle count sizes of 30, 90 and 500. Wellbutrin XL is a trademark of GlaxoSmithKline LLC. ]]> <![CDATA[Dr. Reddy's Laboratories announces the launch of Bupropion Hydrochloride Extended-Release Tablets]]> https://biospectrumindia.com/news/95/9496/dr-reddys-laboratories-announces-the-launch-of-bupropion-hydrochloride-extended-release-tablets.html https://biospectrumindia.com/news/95/9496/dr-reddys-laboratories-announces-the-launch-of-bupropion-hydrochloride-extended-release-tablets.html Wed, 06 Sep 2017 14:20:00 +0530 Dr. Reddy’s Laboratories Ltd. has announced the launch of Bupropion Hydrochloride Extended-Release Tablets, USP (XL), 150 mg and 300 mg. It is a therapeutic equivalent generic version of Wellbutrin XL (Bupropion Hydrochloride Extended-Release) Tablets, approved by the U.S. Food & Drug Administration (USFDA). The Wellbutrin XL brand and generic had U.S. sales of approximately $754 million MAT for the most recent twelve months ending in July 2017 according to IMS Health. Dr. Reddy’s Bupropion Hydrochloride Extended-Release Tablets, USP (XL), 150 mg and 300 mg, are each available in bottle count sizes of 30, 90 and 500. ]]> <![CDATA[Dr. Reddy's Laboratories announces the launch of Metaxalone Tablets]]> https://biospectrumindia.com/news/95/9495/dr-reddys-laboratories-announces-the-launch-of-metaxalone-tablets.html https://biospectrumindia.com/news/95/9495/dr-reddys-laboratories-announces-the-launch-of-metaxalone-tablets.html Wed, 06 Sep 2017 13:45:00 +0530 Dr. Reddy’s Laboratories Ltd. has announced the launch Metaxalone Tablets, USP 800 mg which is a therapeutic equivalent generic version of Skelaxin (metaxalone) Tablets, approved by the U.S. Food and Drug Administration (USFDA). The Skelaxin brand and generic had U.S. sales of approximately $139 million MAT for the most recent twelve months ending in July 2017 according to IMS Health. Dr. Reddy’s Metaxalone Tablets, USP 800 mg are available in the bottle count size of 100. Skelaxin is a trademark of King Pharmaceuticals Research and Development, Inc ]]> <![CDATA[JDRF joins Biocon for global diabetes study]]> https://biospectrumindia.com/news/95/9494/jdrf-joins-biocon-for-global-diabetes-study.html https://biospectrumindia.com/news/95/9494/jdrf-joins-biocon-for-global-diabetes-study.html Wed, 06 Sep 2017 12:25:00 +0530 Asia’s premier biopharmaceuticals company, and JDRF, the leading global organization funding type 1 diabetes (T1D) research and advocacy worldwide, jointly announced a JDRF  partnership to support a global multiple ascending dose study with a novel oral insulin drug candidate, Insulin Tregopil, in people with T1D. Insulin Tregopil, a first-in-class oral insulin molecule being developed by Biocon, is one of the most advanced programs in the global oral insulin space. The fast-acting oral insulin could improve post-prandial glucose control with reduced side effects and greater adherence, thus holding the promise to transform T1D management. Biocon proposes to conduct an open label study to evaluate the pharmacokinetics (PK), pharmacodynamics (PD), safety and tolerability of multiple ascending doses of Insulin Tregopil and to compare the PK, PD and safety of the optimal dose regimen of Insulin Tregopil with therapeutic doses of Insulin Aspart in individuals with T1D. This collaboration with Biocon is a part of JDRF's Industry Discovery and Development Partnership (IDDP) program, through which JDRF provides financial support to accelerate breakthrough research in T1D management. Commenting on the collaboration, Kiran Mazumdar-Shaw, CMD, Biocon said, “We believe Insulin Tregopil can make a significant difference to the diabetes management paradigm for both type 1 and type 2 diabetes and welcome JDRF's support in advancing this unique oral insulin molecule through the clinic for type 1 diabetes. With this proposed clinical study, we hope to build on the extremely promising data that we have generated so far through previous human trials with Tregopil. We are committed to addressing the huge unmet need of people with diabetes by providing the medical community an alternate treatment for postprandial hyperglycaemia.” “JDRF has been supportive of oral insulin studies to help people with type 1 diabetes better manage their glucose levels with less need for injected insulin,” said Esther Latres, JDRF Director, Translational Development, “To achieve that goal would be one incredible step toward improving the quality of life for people with T1D while we strive for our ultimate goal of a cure.” Dr Narendra Chirmule, Sr. Vice President & Head of R&D at Biocon, added, “We are thankful  to JDRF for extending their support to our R&D efforts that are aimed at developing a novel oral insulin to treat type 1 diabetes. The primary objective of this study will be to evaluate the safety and tolerability of multiple ascending doses of Insulin Tregopil in individuals with type 1 diabetes. We are excited to work on this novel molecule and to partner with the world’s leading organization supporting T1D research, JDRF.” Globally, an estimated 422 million adults were living with diabetes in 2014. While separate global estimates of diabetes prevalence for type 1 and type 2 do not exist, it is estimated that 1.25 million Americans are living with T1D. Five million people in the U.S. are expected to have T1D by 2050. Biocon had announced positive clinical data in 2016 for Insulin Tregopil following a set of Phase I studies conducted in the U.S., which established the drug's important role in postprandial glycaemic control. One of the studies demonstrated fast action of Insulin Tregopil with distinctive properties compared to other prandial insulins. Based on the positive data sets, Biocon has decided to advance this research asset through clinical trials for validation in a larger patient cohort. The company has also filed a Clinical Trial Application with the Indian regulator (DCGI) for a Phase II/III study with Insulin Tregopil in type 2 diabetes. ]]> <![CDATA[Merck plans strategy for consumer health biz]]> https://biospectrumindia.com/news/95/9492/merck-plans-strategy-for-consumer-health-biz.html https://biospectrumindia.com/news/95/9492/merck-plans-strategy-for-consumer-health-biz.html Wed, 06 Sep 2017 11:30:00 +0530 Merck is preparing strategic options for its consumer health business, including a potential full or partial sale of the business as well as strategic partnerships. Consumer health is running a strong international business with a number of leading products in attractive Over-the-Counter (OTC) categories. The business focuses on consumer-centric solutions driven by global megatrends and achieved net sales of €860 million in 2016. With well-recognized and highly respected brands and products such as Bion, Femibion, Nasivin, Neurobion, and Seven Seas, Consumer Health has a diversified product portfolio and strong market positions both in developed and emerging markets. Merck has consistently shifted towards becoming a leading science and technology company. Key milestones such as the acquisitions of Sigma-Aldrich, AZ Electronic Materials and Millipore, the divestment of its Biosimilars business as well as the ongoing strategic portfolio shift within the Healthcare business sector have supported this strategy. Recent approvals of Bavencio (Avelumab) in the area of immuno-oncology and Mavenclad (Cladribine tablets) for the treatment of highly active relapsing multiple sclerosis (RMS) are examples of Merck’s successful development of innovative medicines. The pipeline of other highly promising active ingredients in oncology, immuno-oncology and immunology remains very attractive. ]]> <![CDATA[Lupin launches generic Benicar tablets in the US]]> https://biospectrumindia.com/news/95/9481/lupin-launches-generic-benicar-tablets-in-the-us.html https://biospectrumindia.com/news/95/9481/lupin-launches-generic-benicar-tablets-in-the-us.html Mon, 04 Sep 2017 14:50:00 +0530 Pharma company Lupin Limited has announced the launch of its Olmesartan Medoxomil tablets, 5 mg, 20 mg and 40 mg having received an approval from the United States Food and Drug Administration (FDA) earlier. The tablets, 5 mg, 20 mg and 40 mg are the AB rated generic equivalent of Daiichi Sankyo Inc.’s Benicar tablets and indicated for the treatment of hypertension, alone or in combination with other antihypertensive agents, to lower blood pressure. Benicar tablets had US sales of USD 681 million (IMS MAT July 2017). ]]> <![CDATA[Ontario, Canada partners with Apotex Inc.to invest in new technology ]]> https://biospectrumindia.com/news/95/9480/ontario-canada-partners-with-apotex-inc-to-invest-in-new-technology-.html https://biospectrumindia.com/news/95/9480/ontario-canada-partners-with-apotex-inc-to-invest-in-new-technology-.html Mon, 04 Sep 2017 14:15:00 +0530 Ontario, Canada is partnering with Canada based pharmaceutical company, Apotex Inc. to invest in new technology and product development at its Etobicoke, Ontario facility. Shafiq Qaadri, MPP for Etobicoke North, and Yvan Baker, MPP for Etobicoke Centre, made the announcement recently on behalf of Brad Duguid, Minister of Economic Development and Growth. Ontario is providing a grant of up to $8.25 million through the Jobs and Prosperity Fund. This is part of a larger overall investment by the company valued at $222.70 million. The project is scheduled for completion in 2022. With support from Ontario’s Jobs and Prosperity Fund, Apotex is investing in new manufacturing technology and processes that will expand the company’s product range and enhance productivity. Brad Duguid said, “Ontario's broad and innovative life sciences sector is a cornerstone of the province’s knowledge economy and also contributes to improving lives around the world. Through this strategic partnership, Apotex will boost its competitiveness, create jobs and reinforce its position as a key anchor company in Ontario’s life sciences cluster.” Shafiq Qaadri commented, “Apotex has been part of the Etobicoke North community for many years now, and with this support from Ontario’s Jobs and Prosperity Fund it will be able to continue to develop affordable and quality medicine for the global market.” Dr. Jeremy B. Desai, CEO and President, Apotex said, “As a proudly Canadian global pharmaceutical company, we take pride in our long history of investment in Ontario. From research and development, to manufacturing and packaging, our highly skilled workforce is key to delivering on our purpose of providing access to affordable, high quality and innovative healthcare solutions.”       ]]> <![CDATA[Ozone Group moves into hair care sector]]> https://biospectrumindia.com/news/95/9478/ozone-group-moves-into-hair-care-sector.html https://biospectrumindia.com/news/95/9478/ozone-group-moves-into-hair-care-sector.html Mon, 04 Sep 2017 11:50:00 +0530 Delhi-based Ozone Group plans to scale up its consumer products business in the next three-to-five years. It is eyeing future growth from segments such as beauty, eyecare, pain management and women hygiene. The company also announced its partnership with Brazil’s Embelleze to foray into the professional hair care segment. The company had sold its successful skincare brand Nomarks to Bajaj Corp in 2013. The company’s current turnover is about Rs. 200 crore. A big chunk of its revenues come from its pharmaceuticals business, which it aims to grow at 25-30 per cent year-on-year. The company will also be leveraging on its association with Embelleze, Brazil, to distribute a range of professional hair care products under brands Novex and Nutrisalon. These will be sold to salons and include shampoos, conditioners, hair spas and hair treatment products. The company already has presence in the professional skin care segment. ]]> <![CDATA[Prega News enter into new partnership with SpiceJet ]]> https://biospectrumindia.com/news/95/9448/prega-news-enter-into-new-partnership-with-spicejet-.html https://biospectrumindia.com/news/95/9448/prega-news-enter-into-new-partnership-with-spicejet-.html Mon, 28 Aug 2017 12:40:00 +0530 Prega News from Mankind Pharmaceuticals has recently announced an innovative initiative for expectant mothers. The brand has partnered with SpiceJet to launch a series of initiatives to make air travel for pregnant women more comfortable and enjoyable. As part of this initiative, a SpiceJet aircraft Boeing 737-800 Series has been fully body wrapped with Prega News branding. From the time tickets are booked until they reach their destinations, expecting mothers will be pampered and cared for with utmost attention by the SpiceJet team in this uniquely branded aircraft. Announcing this unique initiative, Rajeev Juneja, CEO, Mankind Pharma said, “Prega News is a leading brand in pregnancy detection kits. Our focus has always been women and how to make life comfortable and easy for expectant mothers. Through our campaigns, we acknowledge one of the most beautiful stages of a woman’s life, which is ‘Motherhood’. In our first campaign, we had highlighted issues concerning pregnant women and work place challenges. The current campaign is about taking care and pampering pregnant women during the travels. We are sure our campaigns will connect with our target audience and touch an emotional chord leading to a changing dynamic in the workforce.” Debojo Maharshi, Chief Marketing Officer SpiceJet shared, “SpiceJet is excited to be associated with Mankind Pharma in their upcoming campaign for expecting mothers. We, at SpiceJet felt that this was a unique initiative as well as an opportunity to do our bit for the ‘real creators’ that are there with us that is, mothers! Being a partner in this integration, SpiceJet is pledging its prime real estate i.e. plane wrap for the integration. The wrap will cover both sides of the aircraft. We feel that this wrap will add the gravitas behind the initiative and give the much-deserved impetus to it.”   ]]> <![CDATA[Dr. Reddy’s launches Cefixime for Oral Suspension]]> https://biospectrumindia.com/news/95/9447/dr-reddys-launches-cefixime-for-oral-suspension.html https://biospectrumindia.com/news/95/9447/dr-reddys-launches-cefixime-for-oral-suspension.html Mon, 28 Aug 2017 12:15:00 +0530 Dr. Reddy’s Laboratories Ltd. has announced that it has launched Cefixime for Oral Suspension, USP 100 mg/5mL and 200 mg/5mL, a therapeutic equivalent generic version of Suprax (cefixime) for Oral Suspension, approved by the U.S. Food and Drug Administration (USFDA). The Suprax brand and generic had U.S. sales of approximately $50.5 million MAT for the most recent twelve months ending in June 2017 according to IMS Health. Dr. Reddy’s Cefixime for Oral Suspension, USP is available in strengths of 100 mg/5mL and 200 mg/5mL after reconstitution. The 100 mg/5 mL strength is available in 50 mL bottles. The 200 mg/5 mL strength is available in 75 mL and 50 mL bottles.  Suprax is a registered trademark of Astellas Pharma Inc. ]]> <![CDATA[Piramal plans organic way for pharma growth]]> https://biospectrumindia.com/news/95/9445/piramal-plans-organic-way-for-pharma-growth.html https://biospectrumindia.com/news/95/9445/piramal-plans-organic-way-for-pharma-growth.html Mon, 28 Aug 2017 11:50:00 +0530 Piramal Enterprises Ltd (PEL) is looking at growing organically in pharmaceutical segment to move up the value chain and expanding in services like antibody drug conjugates, injectables and drug discovery.   In the last two years, the pharma segment deployed around half a billion dollar of capital for future growth through various organic as well as inorganic initiatives. PEL is now looking at investments for expansion of the manufacturing and service delivering capabilities in niche areas of ADC, injectables, inhalation anaesthesia and discovery services. It also plans to launch first generic version of Desflurane, the latest generation inhalation anaesthesia product, in FY18. Last year, the company added two niche differentiated product portfolios in global pharma products business. It has acquired a portfolio of five branded products in the injectable anaesthesia and pain management area from Janssen and a portfolio of intrathecal spasticity and two pain management products under development from Mallinckrodt LLC. The company has strengthened its presence in North America and Europe - and generates over 70 percent of its revenues from these two geographies, which host close to 70 percent of its assets. ]]> <![CDATA[MDR TB drug by Otsuka reaches India]]> https://biospectrumindia.com/news/95/9441/mdr-tb-drug-by-otsuka-reaches-india.html https://biospectrumindia.com/news/95/9441/mdr-tb-drug-by-otsuka-reaches-india.html Fri, 25 Aug 2017 08:05:00 +0530 Japanese drug maker Otsuka Pharmaceutical has granted US pharmaceutical firm Mylan’s subsidiary an exclusive license to supply to India and South Africa a drug to treat patients with pulmonary multi-drug resistant tuberculosis (MDR TB). The agreement is expected to speed up India’s access to the potentially life-saving drug, which had not been made available in the country despite Otsuka having received a patent for it back in 2011. The Drug Controller General of India (DCGI), India’s apex drug regulator, has granted Mylan’s subsidiary approval for the drug. The drug, delamanid, was discovered and developed by Otsuka. The Revised National Tuberculosis Control Program (RNTCP) will now begin drafting the protocol to administer delamanid with other drugs to patients with MDR TB and identify sites where the drug will be rolled out. Mylan will use clinical data from these sites to conduct a post marketing survey, after which DCGI may give them permission to introduce it in the private market. The government intends to enter into discussions with Mylan to ensure that delamanid remains affordable to India. The only other drug available in India for patients with MDR TB, a growing issue in the country, is bedaquiline by Johnson & Johnson. This drug was introduced last year and is also supplied to a limited number of patients through the government's conditional access program.   ]]> <![CDATA[Generic Seroquel XR tablets launched by Lupin in USA]]> https://biospectrumindia.com/news/95/9436/generic-seroquel-xr-tablets-launched-by-lupin-in-usa.html https://biospectrumindia.com/news/95/9436/generic-seroquel-xr-tablets-launched-by-lupin-in-usa.html Thu, 24 Aug 2017 11:25:00 +0530 Lupin Limited has announced the launch of its Quetiapine Fumarate Extended-Release Tablets, 50 mg, 150 mg, 200 mg, 300 mg and 400 mg. The tablet was approval from the United States Food and Drug Administration (FDA) earlier. Lupin’s Quetiapine Fumarate Extended-Release Tablets, 50 mg, 150 mg, 200 mg, 300 mg and 400 mg are the AB rated generic equivalent of AstraZeneca Pharmaceuticals LP’s Seroquel XR® Tablets, 50 mg, 150 mg, 200 mg, 300 mg and 400 mg. It is indicated for the treatment of schizophrenia; acute manic or mixed episodes in bipolar I disorder alone or as an adjunct to lithium or divalproex; acute depressive episodes in bipolar disorder; maintenance treatment of bipolar I disorder, as an adjunct to lithium or divalproex and as an adjunctive therapy to antidepressants for the treatment of major depressive disorder. ]]> <![CDATA[Novartis and MMV launch patient trial in Africa for KAF156]]> https://biospectrumindia.com/news/95/9434/novartis-and-mmv-launch-patient-trial-in-africa-for-kaf156.html https://biospectrumindia.com/news/95/9434/novartis-and-mmv-launch-patient-trial-in-africa-for-kaf156.html Wed, 23 Aug 2017 11:45:00 +0530 Novartis and Medicines for Malaria Venture (MMV) have recently launched a patient trial for KAF156 which is a next-generation antimalarial compound with the potential to treat drug-resistant strains of the malaria parasite. This trial will test the efficacy of KAF156 in combination with a new, improved formulation of the existing antimalarial lumefantrine. The first trial center is operational in Mali and will be followed by sixteen additional centers across a total of nine countries in Africa and Asia over the next few months.   MMV is a product development partnership (PDP) in the field of antimalarial drug research and development. Its mission is to reduce the burden of malaria in disease-endemic countries by discovering, developing and delivering new, effective and affordable antimalarial drugs. Vas Narasimhan, Global Head of Drug Development and Chief Medical Officer, Novartis said, "This new milestone underscores our company's long-standing commitment to the fight against malaria. With nearly half of the world's population at risk, malaria continues to be a major public health challenge. Developing new antimalarial medicines is critical to achieving malaria elimination. Innovative science continues to be our best weapon against the disease." KAF156 belongs to a novel class of antimalarial compounds called imidazolopiperazines and it has the potential to clear malaria infection, including resistant strains, as well as to block the transmission of the malaria parasite. Phase IIa proof-of-concept trial demonstrated that the compound is fast-acting and potent across multiple stages of the parasite's lifecycle, rapidly clearing both P. falciparum and P. vivaxparasites. The phase IIb study will test multiple dosing combinations and dosing schedules of KAF156 and lumefantrine, including the feasibility of a single dose therapy in adults, adolescents and children. Dr David Reddy, CEO of MMV said, "To build on the gains made against malaria since the turn of the century, we need new medicines that are effective across all types of resistance patterns and geographies, and that are easy to administer, especially to children. With the phase IIb trial of KAF156-lumefantrine now underway, the MMV-Novartis partnership is drawing closer to the exciting prospect of such a new medicine that would be a powerful tool to fight the disease." Dr. Bakary Fofana, clinical trial investigator at the Malaria Research and Training Center in Bougoula – Hameau said, "Malaria is a major public health concern in Mali - especially for children. Thus, the need for novel antimalarials is urgent. Because it is a new compound with the potential to treat malaria including strains resistant to currently used antimalarials, we are particularly motivated to run the KAF156 patient trial at our site in Mali." KAF156 is the result of a Wellcome Trust, MMV and Singapore Economic Development Board supported joint research program with the Novartis Institute for Tropical Diseases, the Genomics Institute of the Novartis Research Foundation, and the Swiss Tropical and Public Health Institute. Novartis is developing KAF156 with scientific and financial support from MMV (in collaboration with the Bill & Melinda Gates Foundation). The partnership between MMV and Novartis builds on a long-standing successful collaboration in antimalarial drug development, which led to the launch in 2009 of the first high-quality artemisinin combination therapy for children.   ]]> <![CDATA[Eisai introduces first-in-Class Epilepsy Treatment Fycompa (Perampanel) in India]]> https://biospectrumindia.com/news/95/9429/eisai-introduces-first-in-class-epilepsy-treatment-fycompa-perampanel-in-india.html https://biospectrumindia.com/news/95/9429/eisai-introduces-first-in-class-epilepsy-treatment-fycompa-perampanel-in-india.html Tue, 22 Aug 2017 17:45:00 +0530 Eisai Pharmaceuticals India Pvt. Ltd, a leading Japanese pharmaceutical company announced the launch of Fycompa (perampanel), a new anti-epileptic drug. Approved in more than 55 countries worldwide, Fycompa is indicated as an adjunctive therapy for the treatment of partial-onset seizures (POS) with or without secondarily generalized seizures in patients with epilepsy aged 12 and older. Fycompa is first in class in-house developed anti-epileptic drug, available in tablet form as a once-daily oral dose. “Nearly 12 million patients in India suffer from epilepsy and 95% of these patients do not receive adequate treatment. Abiding by our core philosophy of human health care we strive to change this by developing a drug that can significantly improve the quality of life of epileptic patients and give them hope to live a seizure free-life,” said Mr. Sanjit Singh Lamba, Managing Director, Eisai Pharmaceuticals India.” He further added, “Epilepsy has been a therapeutic focus area for Eisai and we will continue to use our strengths in research and development to create drugs that will improve and enhance the quality of life.” Adding to this Dr. Manoj Malhotra – Head of Medical Affairs, Americas Region, Global Head of Epilepsy Medical Affairs, Neurology Business Group, Eisai Inc. said “With the launch of many anti-epileptic drugs in the last decade we have seen a significant improvement in seizure freedom rate. However, almost 30-40% of the seizures remain poorly controlled leading to low compliance. Fycompa will help to address these key therapeutic challenges and improve patient outcomes”. Commenting on the low awareness on epilepsy, Mr. Saumil Mody- Vice President, Commercial Operations, Eisai India Ltd. said “Treatment outcomes for epilepsy are very low because we are dealing with very challenging circumstances, a majority of epilepsy cases go undiagnosed because of numerous factors like the social stigma associated with the disease, lack of awareness of the symptoms particularly in rural India. Our aim is to address these challenges and enable epileptic patients and their families to live a seizure-free life.” Epilepsy is a condition that affects the brain and causes repeated seizures. Approximately 50 million people worldwide have epilepsy, making it one of the most common neurological diseases globally. ]]> <![CDATA[Dr. Reddy’s out-licenses a dermatology drug]]> https://biospectrumindia.com/news/95/9427/dr-reddys-out-licenses-a-dermatology-drug.html https://biospectrumindia.com/news/95/9427/dr-reddys-out-licenses-a-dermatology-drug.html Tue, 22 Aug 2017 15:20:00 +0530 Dr. Reddy’s Laboratories Ltd., through its wholly owned subsidiary Promius Pharma, announced that it has out-licensed the future development, manufacturing, and commercialization rights of DFD-06, a topical high potency steroid, to Encore Dermatology Inc. The drug is intended to be used for treatment of moderate to severe plaque psoriasis. Under the terms of the agreement, Encore will be responsible for the commercialization of DFD-06 in the United States. Promius Pharma is eligible to receive certain pre- and post- commercialization milestone payments of up to $32.5 million, followed by fixed royalty payments on net sales. “We believe Encore and its management team are well positioned to realize the full potential of this asset DFD-06. We look forward to obtaining NDA approval this fall, enabling Encore’s management team to quickly deliver this product to the providers and their patients.” says Anil Namboodiripad, Ph.D., Senior Vice President, Proprietary Products, and President, Promius Pharma. ]]> <![CDATA[Aurobindo Pharma plans new growth strategies]]> https://biospectrumindia.com/news/95/9418/aurobindo-pharma-plans-new-growth-strategies.html https://biospectrumindia.com/news/95/9418/aurobindo-pharma-plans-new-growth-strategies.html Mon, 21 Aug 2017 11:25:00 +0530 Aurobindo Pharma would broaden product portfolio in the US while entering new markets in Europe as part of its growth strategy over the next 3-4 years. In the US, it plans to broaden portfolio through accelerated growth in injectable, OTC and higher complexity products. On the other hand, in Europe, the company is planning to expand presence into new geographies such as Poland and Czech Republic besides enhancing its position in existing countries such as France, Germany, Netherlands, Spain and the UK. Aurobindo has been following a strategy of differentiated pipeline with new launches, including injectables, ophthalmics, speciality products and controlled substances in the US market. Moreover, it has also expanded presence in dietary supplement business through Natrol, which it had acquired in 2014. In Europe, Aurobindo is seeking to augment position through new product launches and extension to select Eastern Europe markets. Going forward, it plans to expand presence into new geographies such as Poland and Czech Republic. The key markets for the company in Europe are France, Germany, Netherlands, Spain, UK, Portugal and Italy. Lower generics penetration in Italy, Spain, Portugal and France offers future growth potential in next three to four years as share of generics improves. The Hyderabad-based firm is also aiming for portfolio expansion through targeted Day 1 launches in segments such as orals, hormones and penems, oncology products, niche injectables and low volume injectables in the European market. In its growth markets such as Ukraine, Mexico, Tanzania, Colombia, South Africa, Canada, Brazil and GCC Countries, the company is aiming to build branded generics presence in next three to four years. It is also seeking to enhance penetration in select markets through local manufacturing with plans to expand presence in oncology and speciality injectables segments. Aurobindo Pharma had posted consolidated net revenue from operations of Rs 3,678.7 crore for the first quarter ended June 30, 2017-18. Out of this the US formulation sales were at Rs 1,694.9 crore and Europe formulations sales were at Rs 917.6 crore. ]]> <![CDATA[Suven Life Sciences receives patents for new chemical entities]]> https://biospectrumindia.com/news/95/9412/suven-life-sciences-receives-patents-for-new-chemical-entities.html https://biospectrumindia.com/news/95/9412/suven-life-sciences-receives-patents-for-new-chemical-entities.html Fri, 18 Aug 2017 12:35:00 +0530 Suven Life Sciences has secured the processes patents from Europe, Japan and New Zealand. The company has received patents for new chemical entities (NCEs) which are for the treatment of disorders associated with neurodegenerative diseases and these patents are valid through 2034. Suven Life Science is a biopharmaceutical company focused on discovering, developing and commercialising novel pharmaceutical products, which are best in class CNS therapies using GPCR targets. These process patents are for company’s pipeline compounds which are in the class of selective 5HT6 compounds and are being developed as therapeutic agents and useful in the treatment of cognitive impairment associated with neurodegenerative disorders like Alzheimer’s disease, Attention deficient hyperactivity disorder (ADHD), Huntington’s disease, Parkinson and Schizophrenia. Suven Life CEO Venkat Jasti stated that the company is very pleased by the grant of these patents to Suven for the pipeline of molecules in CNS arena that are being developed for cognitive disorders with high unmet medical need with huge market potential globally. ]]> <![CDATA[Growing pharma sector to boost laboratory, analysis and diagnostics market in India]]> https://biospectrumindia.com/news/95/9406/growing-pharma-sector-to-boost-laboratory-analysis-and-diagnostics-market-in-india.html https://biospectrumindia.com/news/95/9406/growing-pharma-sector-to-boost-laboratory-analysis-and-diagnostics-market-in-india.html Thu, 17 Aug 2017 17:50:00 +0530 The Indian pharma industry has been growing at a compounded annual growth rate (CAGR) of more than 15% over the last five years and is expected to grow to US$ 100 billion by 2025. The Union Cabinet (Indian government) has given its go-ahead for the amendment of the existing Foreign Direct Investment (FDI) policy in the pharmaceutical sector in order to allow FDI up to 100 per cent under the automatic route for manufacturing of medical devices subject to certain conditions. The drugs and pharmaceuticals sector attracted cumulative FDI inflows worth US$ 14.53 billion between April 2000 and December 2016, according to data released by the Department of Industrial Policy and Promotion (DIPP). Analytica Anacon India and India Lab Expo, India’s leading trade fairs and conference for laboratory technology, analysis, biotechnology and diagnostics will capitalize on this growth opportunity by bringing industry stakeholders together at one place. Manufacturers, suppliers, dealers and representatives of Indian and international manufacturers will display the best of laboratory technology, analysis and biotechnology products, solutions and technologies. Analytica Anacon India and India Lab Expo is co-organized with Indian Analytical Instruments Association (IAIA) and has received strong support from all major trade associations including Pharmexcil, Indian Drug Manufacturers' Association (IDMA), Indian Chemical Council (ICC) and many more. The Government of India unveiled 'Pharma Vision 2020' aimed at making India a global leader in end-to-end drug manufacturing. Such positive developments and investments in the pharma sector are likely to create more demand for laboratory, analysis and diagnostics. This implies increased usage of laboratory instruments and allied technologies by pharmaceutical companies, research labs, and others. While Indian market for laboratory instruments and analysis is majorly driven by pharma sector, some of the other key sectors which will drive the demand for laboratory and analysis market include performance and R&D spending of chemical, food & beverages, oil & gas etc. According to Madan Mohan Reddy, Chairman, Pharmaceuticals Export Promotion Council Pharmexcil said, “The pharmaceutical sector will continue to grow in future and is expected to become third largest pharmaceuticals market by 2020 in terms of incremental growth and can generate USD 45 Billion in revenue by then.” Bhupinder Singh, CEO of Messe Muenchen India said, “The growth in pharmaceutical industry is a positive news. It means more opportunities for the laboratory, analysis and diagnostics market in India.” “Our trade fairs, analytica Anacon India and India Lab Expo will continue to offer industry professionals - ample of opportunities to network, learn and see new technologies. Based on these positive economic forecasts, we are convinced that pharmaceutical and other industries which drive growth in laboratory and analysis market will continue their development”, he added Navin Mehta, Managing Director, Newtronic Equipment, underlines the importance of Analytica Anacon India and India Lab Expo as a platform for exchange in this growing sector and sums up his participation in the trade fairs in 2016. “We have, as usual, received a great response from the pharma community in Hyderabad and really had successful three days.” Scientists in research and industry develop new active ingredients and solutions to the latest problems in the pharmaceutical industry and medicine. State-of-the-art technology and corresponding know-how are guarantees of the industry’s ability to innovate. Technology transfer, patents and approval procedures are key factors of success in the chemical and pharmaceutical industry. Analytica Anacon India and India Lab Expo depict the industry in its entirely – both in the exhibition and in the program of related events. Exhibitors present the latest equipment solutions and developments for the stringent demands of pharmaceutical research and demonstrate them being used in practical applications.     ]]> <![CDATA[National Bio Entrepreneurship Competition launched by Y.S. Chowdary]]> https://biospectrumindia.com/news/95/9403/national-bio-entrepreneurship-competition-launched-by-y-s-chowdary.html https://biospectrumindia.com/news/95/9403/national-bio-entrepreneurship-competition-launched-by-y-s-chowdary.html Thu, 17 Aug 2017 15:25:00 +0530 The National Bio Entrepreneurship Competition which is a national platform to attract, identify and nurture bio-entrepreneurs with path-breaking ideas for societal impact has been launched by . Y. S. Chowdary, Minister of State, Science and Technology. With an objective of encouraging the spirit of bio-entrepreneurship, facilitating the creation of life science start-ups and mentoring start-ups to increase their chances of success, Biotechnology Industrial Research Assistance Council (BIRAC) in partnership with C-CAMP has set up the BIRAC Regional Entrepreneurship Centre (BREC) in C-CAMP. Prof. Vijay Raghavan, Secretary, Department of Biotechnology (DBT) and Dr.RenuSwarup, Senior Advisor, DBT, and Managing Director, Biotechnology Industry Research Assistance Council (BIRAC) were also present in the event. In his address, Y. S. Chowdary said, “I am happy that BIRAC and C-CAMP have initiated this very important mission. The National Bio Entrepreneurship Competition will bring to the forefront biotech ideas from all across our country that can potentially address the healthcare, agriculture, food, nutrition and environmental challenges we face. I look forward to see this being an annual celebration of bio-entrepreneurship.”  Speaking at the event, Prof.Vijay Raghavan said, “I am thrilled to be at the launch of the National Bio Entrepreneurship Competition by BIRAC and C-CAMP. India’s biotech entrepreneurship can go into exponential growth if further bold support and policies to engines of innovation like this are put in place. This is happening. It is vital to set goals to be achieved by 2022 and work towards them. Initiatives which are anchored with Government support and private partnership will flourish and I am delighted that C-CAMP has been able to bring in both these for the National Bio Entrepreneurship Competition.” Dr. Renu Swarup said on the occasion, “We are delighted that BIRAC Regional Entrepreneurship Centre- BREC at C-CAMP has launched the National Bio Entrepreneurship Competition. This will usher a multiplier effect on the biotech innovation ecosystem and encourage biotech start-ups to move to the next level. We thank all the partners who are contributing to this award.” Speaking at the launch, Dr. Satya Prakash Dash, Head SPED, BIRAC said, “The National Bio Entrepreneurship Competition has come at an optimal time when we are in midst of a transformational change in the Indian biotech start-up culture. This award will propel and quicken the transformation.” Dr. Taslimarif Saiyed, CEO and Director C-CAMP, said, “We are delighted that the Hon’ble Minister launched this event today in the presence of DBT secretary and Dr.Swarup. We are excited to attract and work with the best entrepreneurial talent across the country towards addressing societal challenges. We are extremely thankful to DBT and BIRAC for their continued support.” Selected participants will be attending a 3-day residential Entrepreneurship Development boot camp at C-CAMP, Bengaluru, which will train them to formulate, develop and commercialize their ideas. The entrepreneurs with the best ideas stand to win investment opportunity up to USD $100,000, grand cash prize of INR 10 lakhs for different category winners, business acceleration, mentoring, and access to seed funding.   ]]> <![CDATA[CLINICA 2017 to be organised by ABC Biologics]]> https://biospectrumindia.com/news/95/9398/clinica-2017-to-be-organised-by-abc-biologics.html https://biospectrumindia.com/news/95/9398/clinica-2017-to-be-organised-by-abc-biologics.html Wed, 16 Aug 2017 18:00:00 +0530 ABC Biologics is all set to organise first International Conference on “Recent trends and approaches in Clinical Research, Clinical Trial and Medical Writing”. Entitled as CLINICA 2017, this event will going to be held on 1st September at The aloft Hotel, Whitefield, Bangalore. Clinical research is a critical component of pharmaceutical research and development and it ensures a quicker and better return on investment made for the pharma company. Risk based approach, evolving global regulatory expectations on data integrity of clinical research, novel considerations in study design and different quality attributes of medical writing are some of the emerging trends in this sector. The conference aims to educate health care researchers about study design, operation, organizing, research computing, regulatory aspects and reporting of clinical trials. Dr.Sam T Mathew Global Head: Clinical eSubmission & Technical Compliance GlaxoSmithKline Vaccines, Dr.Saral Thangam, CEO ,Norwich clinical Services, India and Tapankumar Shah Country Head - Clinical Operations AstraZeneca Pharma India Ltd. are some of the speakers. President, vice-president, director, managers, scientist from the clinical research departments of various pharmaceutical companies will also be present.   ]]> <![CDATA[Johnson & Johnson announces Partnership with CSIR-IMTECH]]> https://biospectrumindia.com/news/95/9397/johnson-johnson-announces-partnership-with-csir-imtech.html https://biospectrumindia.com/news/95/9397/johnson-johnson-announces-partnership-with-csir-imtech.html Wed, 16 Aug 2017 17:40:00 +0530 Johnson & Johnson Private Limited recently announced a new partnership with the Institute of Microbial Technology (IMTECH), part of the Council of Scientific and Industrial Research (CSIR), to unlock the potential of Indian science and help accelerate the discovery of innovative new treatments for tuberculosis (TB). Under the Memorandum of Understanding (MoU), scientists from Johnson & Johnson’s global public health team will work closely with scientists from CSIR-IMTECH, based in Chandigarh, India, on a research and development program to explore potentially more effective, safer, all-oral treatment regimens to tackle multidrug-resistant TB (MDR-TB), as well as new molecular entities to treat all TB patients. “We are united with India in our determination to make TB history,” said Paul Stoffels, MD, Chief Scientific Officer, Johnson & Johnson, who joined Dr Harsh Vardhan, Minister for Science and Technology, at an event in New Delhi, to announce the MoU. “While we have made great advances in recent years with the approval of new TB medicines, much more needs to be done.  By bringing together some of India’s brightest minds with our scientists, we increase the potential to achieve major research breakthroughs that can lead to innovative new treatments for the millions of people in India and around the world who suffer from TB.” The new research program will capitalize on CSIR-IMTECH’s world-class expertise in microbial technology and research and the proven research and development capabilities of Johnson & Johnson’s Janssen Pharmaceutical Companies to strengthen the collective potential of our research efforts. “TB remains a significant challenge in India, killing approximately half a million-people in 2015 alone,” said Dr. Anil Koul, Director, CSIR-IMTECH. “The partnership we have announced today with Johnson & Johnson has the potential to accelerate our work in support of India’s National Strategic Plan, our accelerated action plan to End TB by 2025, and most importantly save lives.” Today’s announcement builds on nearly 20 years of TB research and development by Johnson & Johnson, which led to the approval of bedaquiline, the first new TB medicine in nearly 50 years, and adds to existing partnerships at central and state levels in India to increase awareness, diagnosis and care, and broaden access to bedaquiline. In March 2016, Janssen India and the Revised National Tuberculosis Control Program (under the aegis of the Director General of Health Services) announced a Conditional Access Program (CAP) to provide bedaquiline free-of-charge for 600 patients across six sites in India. In April 2017, it was confirmed that the CAP would be expanded to additional TB patients across 156 sites. Janssen India has also partnered with authorities in Mumbai, Telangana, Patna and Nagpur to increase awareness of TB and improve access to diagnosis, treatment and care. “Johnson & Johnson companies have been serving the healthcare needs of India for seventy years now; and this partnership forms an important part of our commitment to the government’s ‘Make in India’ program, supporting Indian drug development for a disease that affects more than 2.8 million people in our country,” added Sanjiv Navangul, Managing Director, Janssen India. ]]> <![CDATA[Lupin’s alliance partner Natco receives FDA approval for generic Fosrenol Chewable Tablets]]> https://biospectrumindia.com/news/95/9396/lupins-alliance-partner-natco-receives-fda-approval-for-generic-fosrenol-chewable-tablets.html https://biospectrumindia.com/news/95/9396/lupins-alliance-partner-natco-receives-fda-approval-for-generic-fosrenol-chewable-tablets.html Wed, 16 Aug 2017 16:10:00 +0530 Pharma major Lupin Limited (Lupin) and Natco announced the final ANDA approval of Lanthanum Carbonate Chewable Tablets 500 mg (base), 750 mg (base), and 1000 mg (base) from the United States Food and Drug Administration (FDA). Natco’s Lanthanum Carbonate Chewable Tablets 500 mg (base), 750 mg (base), and 1000 mg (base) are generic equivalents of Shire Development LLC’s Fosrenol Chewable Tablets 500 mg, 750 mg and 1000 mg. They are indicated to reduce serum phosphate in patients with end stage renal disease (ESRD). Fosrenol Chewable Tablets has US sales of USD 122.4 million (IMS MAT June 2017). Lupin and Natco had entered into an agreement on September 01, 2008 to jointly commercialize generic equivalents of Fosrenol Chewable Tablets. Commenting on the approval, Nilesh Gupta, Managing Director, Lupin said, “We are very happy to finally be able to launch Lanthanum Carbonate Chewable Tablets in partnership with Natco. Lupin’s proven IP capabilities, marketing reach and expertise coupled with Natco’s solid development and manufacturing abilities make a great combination”.    ]]> <![CDATA[ABLE & FIRM announce industry and research collaboration]]> https://biospectrumindia.com/news/95/9380/able-firm-announce-industry-and-research-collaboration.html https://biospectrumindia.com/news/95/9380/able-firm-announce-industry-and-research-collaboration.html Fri, 11 Aug 2017 13:30:00 +0530 The Association of Biotechnology Led Enterprise (ABLE), a not-for-profit, pan-India forum that represents the Indian Biotechnology Sector and the Forum for Innovative Regenerative Medicine (FIRM), an industry organization with a mission to accelerate research and commercialization of regenerative medicine in Japan have entered into a collaborative agreement to work together to advance regenerative medicine and cell and gene therapies within India, Japan and internationally. The Memorandum of Understanding was signed by Manohar, CEO, Stempeutics Research & Head – Committee for Regenerative Medicine Group, Association of Biotech Led Enterprises (ABLE) and Yuzo Toda, Senior Executive Vice President, CTO, Director, FUJIFILM Corporation & Chairman, Forum for Innovative Regenerative Medicine (FIRM) in the presence of Dr. Jagdish Prasad – DGHS, Government of India and Dr. G N Singh – DCG (I), Government of India and other eminent dignitaries. The collaborative programs between ABLE and FIRM will focus on advancing the individual and common missions by sharing information including technology, policy, laws etc. partnerships and opportunities such as co-sponsoring meetings and other cooperation based on common concern. The partnership is a unique platform to advance and promote commercialization of life saving products in regenerative medicine in both the countries. On the occasion of this collaboration, Manohar, CEO, Stempeutics Research & Head – Committee for Regenerative Medicine Group, Association of Biotech Led Enterprises (ABLE) said, “We are proud to be a partner of the prestigious Forum for Innovative Regenerative Medicine (FIRM) in this revolutionary research and industry collaborations. The partnership is a step forward to enhance the learning and training on cell and gene treatment leading to enhancement of the cell and gene therapies which help to address major unmet medical needs in India. We look forward to working with FIRM and contribute towards controlling and curing major human illness.” “Regenerative medicine and cell & gene therapies are the most noteworthy developing innovation according to medical, biotechnology and pharmaceuticals. Our association with ABLE is an opportunity to work towards the advancement of the field and tap on the potential to transform human healthcare. Through the partnership, we can share learnings and insights to contribute towards curing major human illness.” said, Takuya Yokokawa- Healthcare Business Development, Fujifilm Corporation & Chair, Steering Committee, Forum for Innovative Regenerative Medicine (FIRM). ]]> <![CDATA[FDA approval for Lupin’s Nikita (Pitavastatin) tablets]]> https://biospectrumindia.com/news/95/9372/fda-approval-for-lupins-nikita-pitavastatin-tablets.html https://biospectrumindia.com/news/95/9372/fda-approval-for-lupins-nikita-pitavastatin-tablets.html Wed, 09 Aug 2017 11:40:00 +0530 Pharma company Lupin Limited has announced that it has received a 505 (b) (2) NDA approval for its NikitaTM (Pitavastatin) Tablets 1 mg, 2 mg and 4 mg from the United States Food and Drug Administration (FDA). These tablets are Pitavastatin Sodium which is an alternate salt product of Kowa Company Ltd’s Livalo (Pitavastatin Calcium) Tablets. It is a new option for patients with primary hyperlipidemia or mixed dyslipidemia as an adjunctive therapy to diet to reduce elevated total cholesterol, low-density lipoprotein cholesterol, apolipoprotein B, triglycerides and to increase high-density lipoprotein cholesterol. ]]> <![CDATA[UBM India announces 4rth edition of PharmaLytica event]]> https://biospectrumindia.com/news/95/9356/ubm-india-announces-4rth-edition-of-pharmalytica-event.html https://biospectrumindia.com/news/95/9356/ubm-india-announces-4rth-edition-of-pharmalytica-event.html Fri, 04 Aug 2017 12:15:00 +0530 UBM India, organizers of CPhI / P-MEC India, the leading global pharma trade show and conference, announced the 4th edition of PharmaLytica 2017. The two day event will be held at the HITEX Exhibition Center, Hyderabad on 11th & 12th August 2017. PharmaLytica 2017 provides an ideal platform for pharma professionals from the Analytical & Bio Tech, Lab equipments & Lab Chemicals, Pharma Machinery and Packaging sub-sectors, to keep abreast with innovations in the growing businesses of India’s pharma industry. The 4th edition of the expo will see the participation of over 150 exhibitors from across the country including notable industry players such as Standard Group of Companies, Sanitt Equipment & Machines, Gandhi Automations, Mack Pharmatech, S.K. Pharma Machinery, Sterimax Engineering, Utopia Optovision, Rahul Enterprises, Chemipack India, Shree Naina Glass, Komal Industries, Allpharm Technologies, Subodh Engineering, Kirloskar Pneumatic, Integrated Cleanroom Technology, Accura Pharmaquip Inos Technologies among others. Over 100 exhibiting companies will participate for the first time at the show, reiterating its acknowledged pole position in the South. The event also comprises the PharmaLytica Seminar, covering a number of insightful sessions and discussions on latest industry trends. To enhance the touch-and-feel aspect of the expo, one of the much anticipated highlights will be the inclusion of an Innovation Gallery where visitors get to view first-hand, the eye-catching innovations and technology offered by the exhibitors. The companies showcasing their innovations include, Spraytech Systems Pvt Ltd, Hindustan Inox, Nord Drivesystems Pvt Ltd., Fuji Electric India, NHIVA Technologies, Fab Lab India, June Enterprises: Bio Clean, Himsan Polymer and P.R. Packaging’s Ltd. amongst others. PharmaLytica 2017 is being held at a time of vital transformation for the pharma sector. Currently, the National Pharma Policy is being drafted by the Government to ensure, much like its far-sighted ‘Pharma Vision 2020’ campaign, that India emerges as a true global leader in drug manufacturing. Issues of affordability and availability of medicines through the Drug Price Control Order & the National Pharmaceutical Pricing Authority are being aggressively addressed, along with a reduction of approval time for new facilities, to boost investments. Besides, the pharmaceutical industry is under continuous pressure to discover and develop new drugs to combat complex diseases, and ramp up R&D, innovative technologies, manufacturing & analytical capabilities while being competitive and compliant. PharmaLytica 2017 will help the pharmaceutical community network, engage in significant levels of market intelligence and voice the combined opinion on these trending subjects. Speaking on the announcement of the 4th edition of PharmaLytica, Mr. Yogesh Mudras, Managing Director, UBM India said, “We are delighted to announce the 4th edition of PharmaLytica at Hyderabad. The event gives us an opportunity to reach out to a global audience by showcasing products, and solutions to the decision makers in the industry. With India likely to be placed among the top 3 pharmaceutical markets by incremental growth, and 6th largest market globally in absolute size by 2020, it has truly adhered to the 'Make in India' proposition. But now, the stage could well be set for 'Design, Develop and Make in India’. Comprehensive industry platforms like PharmaLytica act as catalysts, transforming India to an end-to-end, research & innovation-driven biotech manufacturer, with an increasing predisposition towards the analytical technology domain. He further added, “The Telangana government’s plans of setting up a Medical Devices Park and a Pharma City has recently been announced and will complement the existing well-settled pharma industry in Hyderabad. PharmaLytica intends to add even greater value to this ecosystem, and become one of the primary market places for products and services in the city, along the entire value chain in niche segments within the Pharma industry such as Analytical Technology, Laboratory Equipments, Machinery and Packaging.” The expo is well supported by associations that include Pharmexcil, The Association of Contract Research Organisations (ACRO), Confederation of Indian Pharmaceutical Industry (CiPi) and Bulk Drug Manufacturers Association (India) BDMA.   ]]> <![CDATA[Bio Agile receives prestigious award]]> https://biospectrumindia.com/news/95/9351/bio-agile-receives-prestigious-award.html https://biospectrumindia.com/news/95/9351/bio-agile-receives-prestigious-award.html Thu, 03 Aug 2017 15:00:00 +0530 Bio Agile Therapeutics Pvt. Ltd was honoured as the Emerging Clinical Research Organisation of the year 2017 hosted by “Times Television Network - Times Influence National Marketing Excellence Awards (For Excellence in Healthcare)”. Managing Director Ms. Divya Chandradhar received the award held in The Taj Lands’ End, Mumbai on 7th July 2017. The award demonstrates company’s commitment and expertise in providing better clinical research services in India. Bio Agile Therapeutics caters research services to Pharmaceuticals, Nutraceuticals, Herbs, Cosmetics, and Medical Devices industries. The company has been structured to provide quality services to its sponsors. Bio Agile Therapeutics Pvt. Ltd. is a ISO 9001:2015 Certified Company, a privately-owned well established full-service CRO (Contract Research Organization) headquartered in Bangalore, India. The company provides end-to-end clinical trial support for Phase II-IV clinical trials and focuses on conducting successful clinical trials and development programs. ]]> <![CDATA[Generic Lidex Ointment by Lupin receives FDA approval]]> https://biospectrumindia.com/news/95/9348/generic-lidex-ointment-by-lupin-receives-fda-approval.html https://biospectrumindia.com/news/95/9348/generic-lidex-ointment-by-lupin-receives-fda-approval.html Thu, 03 Aug 2017 13:00:00 +0530 Pharma company Lupin Limited has announced that United States Food and Drug Administration (USFDA) has finally approved its Fluocinonide Topical Ointment USP, 0.05% to market a generic version of County Line Pharmaceuticals, LLC’s Lidex Ointment, 0.05%. Indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses, Lupin’s Fluocinonide Topical Ointment USP, 0.05% is AB rated generic equivalent of LLC’s Lidex Ointment, 0.05%. Lidex Ointment had US sales of USD 40.3 million (IMS MAT March 2017). ]]> <![CDATA[Dr. Reddy’s joins hands with US-based Amgen to market three drugs in India]]> https://biospectrumindia.com/news/95/9337/dr-reddys-joins-hands-with-us-based-amgen-to-market-three-drugs-in-india.html https://biospectrumindia.com/news/95/9337/dr-reddys-joins-hands-with-us-based-amgen-to-market-three-drugs-in-india.html Tue, 01 Aug 2017 15:30:00 +0530 Dr Reddy's Laboratories (DRL) has expanded its strategic collaboration with US-based independent biotechnology firm Amgen to market and distribute in India three of latter's medicines, used in the therapy areas of oncology and osteoporosis. Under the terms of collaboration, DRL will commercialise Xgeva (denosumab), Vectibix (panitumumab) and Prolia (denosumab) in India, a company statement said. In 2015, DRL announced an initial strategic collaboration with Amgen to execute a full range of regulatory and commercial services to seek approval and launch Amgen's Kyprolis (carfilzomib), Blincyto (blinatumomab) and Repatha (evolocumab) in India. "It strengthens our constant endeavor to enhance patient's access to novel treatment options across therapy areas. These medicines provide unique treatment options to physicians to address unmet medical need in the area of oncology and osteoporosis," said MV Ramana, DRL's Executive Vice President and Head of Emerging markets and India Business. Penny Wan, Amgen Vice President, and General Manager, Japan Asia Pacific Region said, "We are happy to strengthen our relationship with Dr Reddy's. Amgen is committed to addressing unmet medical needs of patients in India, and we are pleased with the commitment Dr Reddy's has demonstrated toward making our medicines available in India as quickly as possible." Xgeva is a Rank ligand (RANKL) inhibitor and is approved in India for the prevention of skeletal related events in patients with advanced malignancies involving bone. Vectibix (panitumumab) is a cancer medication that interferes with the growth and spread of cancer cells in the body. Prolia is a Rank ligand inhibitor approved in India for the treatment of post-menopausal women with osteoporosis at high risk for fracture and also for treatment of increased bone mass in men with osteoporosis. ]]> <![CDATA[Apotex plans expansion in India]]> https://biospectrumindia.com/news/95/9329/apotex-plans-expansion-in-india.html https://biospectrumindia.com/news/95/9329/apotex-plans-expansion-in-india.html Mon, 31 Jul 2017 12:55:00 +0530 Apotex Research, an Indian subsidiary of global pharmaceutical company Apotex Inc., headquartered in Toronto Canada has announced a significant investment which will further expand its footprint in India. The company has set up its Global Business Services office in Mumbai to provide centralized service delivery for various areas including Medical, Regulatory, Quality, Manufacturing, Administrative and Commercial functions for Apotex globally. In addition, the move will create 200 job openings. The new office, located in Godrej & Boyce Business District, Vikhroli spans over 42,000 square feet and has been designed to maximize collaboration and employee engagement. In 2004, Apotex Research and its sister company, Apotex Pharmachem were established in Bengaluru. Over the last 13 years, it evolved into one of Apotex’s global strategic R&D and manufacturing centres with over 2,500 employees. Operations include API & Formulation R&D, Clinical Research, API and Finished Dose Manufacturing. The state-of the art campus in Bengaluru supplies products to the US, Canada, EU and Australia. Apotex is Canada’s largest privately held pharmaceutical company with a global presence in more than 45 countries with more than 11,000 employees. With its worldwide manufacturing sites, it can manufacture up to 25 billion dosages per year. It produces 300 medicines in 4,000 dosages and formats that are exported to 115 countries. The company will spend $2 billion over the next 10 years on research and development. ]]> <![CDATA[ANDA approval received by Glenmark Pharmaceuticals for Desonide Cream, 0.05%]]> https://biospectrumindia.com/news/95/9327/anda-approval-received-by-glenmark-pharmaceuticals-for-desonide-cream-0-05.html https://biospectrumindia.com/news/95/9327/anda-approval-received-by-glenmark-pharmaceuticals-for-desonide-cream-0-05.html Mon, 31 Jul 2017 12:30:00 +0530 Glenmark Pahrmaceuticals Inc., USA has received an approval by the United States Food & Drug Administration (USFDA) for Desonide Cream, 0.05%. It is the generic version of Desonide Cream, 0.05% of Perrigo New York Inc. According to IMS Health sales data for the 12 month period ending May 2017, the Desonide Cream, 0.05% market1 achieved annual sales of approximately $44.6 million. Glenmark’s current portfolio consists of 120 products authorized for distribution in the U.S. marketplace and 65 ANDA’s pending approval with the U.S. FDA. ]]> <![CDATA[AstraZeneca and Merck ink a collaboration]]> https://biospectrumindia.com/news/95/9324/astrazeneca-and-merck-ink-a-collaboration.html https://biospectrumindia.com/news/95/9324/astrazeneca-and-merck-ink-a-collaboration.html Fri, 28 Jul 2017 12:55:00 +0530 AstraZeneca and Merck & Co., Inc. have entered a global strategic oncology collaboration to co-develop and co-commercialise AstraZeneca’s Lynparza (olaparib) for multiple cancer types. Lynparza is an innovative, first-in-class oral poly ADP ribose polymerase (PARP) inhibitor currently approved for BRCA-mutated ovarian cancer in multiple lines of treatment. Lynparza’s pipeline has grown significantly in the last few years, with 14 indications currently being developed across several tumour types, including breast, prostate and pancreatic cancers. The strategic collaboration is expected to further increase the number of treatment options available to patients. The companies will develop and commercialise Lynparza jointly, both as monotherapy and in combination with other potential medicines. Independently, the companies will develop and commercialise Lynparza in combination with their respective PD-L1 and PD-1 medicines, Imfinzi (durvalumab) and Keytruda (pembrolizumab). The companies will also jointly develop and commercialise AstraZeneca’s selumetinib, an oral, potent, selective inhibitor of MEK, part of the mitogen-activated protein kinase (MAPK) pathway, currently being developed for multiple indications including thyroid cancer. Under the terms of the agreement, AstraZeneca and Merck will share the development and commercialisation costs for Lynparza and selumetinib monotherapy and non-PD-L1/PD-1 combination therapy opportunities. Gross profits from Lynparza and selumetinib Product Sales generated through monotherapies or combination therapies will be shared equally. ]]> <![CDATA[MyHep All launched by Mylan in India]]> https://biospectrumindia.com/news/95/9321/myhep-all-launched-by-mylan-in-india.html https://biospectrumindia.com/news/95/9321/myhep-all-launched-by-mylan-in-india.html Thu, 27 Jul 2017 16:30:00 +0530 Subsidiary of Mylan N.V, Mylan Pharmaceuticals Private Limited subsidiary of Mylan N.V. has announced the launch of Velpatasvir 100 mg/Sofosbuvir 400 mg Tablets under the brand name MyHep All™ in India.  It is a fixed-dose combination tablet indicated for the treatment of chronic hepatitis C virus (HCV) infection in adults, including all six major HCV genotypes. A Velpatasvir 100 mg /Sofosbuvir 400 mg combination product is currently sold by Gilead Sciences in other markets under the brand name EPCLUSA. HCV is a bloodborne virus commonly transmitted through unsafe injection practices, inadequate sterilization of medical equipment, and the transfusion of unscreened blood and blood products.It  can cause both acute and chronic infections. Approximately 55–85% of those infected will develop chronic HCV infection. People with chronic HCV infection are often undiagnosed because the infection can remain asymptomatic for decades. In many instances, symptoms develop because of serious liver damage. Rajiv Malik, President, Mylan said, "Chronic hepatitis C is a significant public health burden in India. When we launched Mylan’s Hepato Care division in January 2015, we did so to increase access to critical, life-saving medicines for patients with chronic HCV and other liver-related conditions. The launch of the fixed-dose combination of MyHep All™ is part of this mission and will help patients adhere to their chronic HCV treatment regimen. Mylan has a longstanding, ongoing commitment to accelerate access and to improve treatment outcomes in India and other developing countries.”   This launch follows Mylan’s successful January 2016 launch of MyHep LVIR™ (Ledipasvir/Sofosbuvir combination) in India.    ]]> <![CDATA[Merck, Pfizer and Corning announce collaboration]]> https://biospectrumindia.com/news/95/9317/merck-pfizer-and-corning-announce-collaboration.html https://biospectrumindia.com/news/95/9317/merck-pfizer-and-corning-announce-collaboration.html Wed, 26 Jul 2017 15:50:00 +0530 Merck, Pfizer and Corning Incorporated have announced collaborations that have enabled the modernization of pharmaceutical packaging with the introduction of Corning Valor Glass. This revolutionary pharmaceutical glass packaging solution enhances the storage and delivery of today’s drug formulations and provides more reliable access to medicines essential to public health. Deep pharmaceutical formulation and manufacturing process insights from Merck and Pfizer, in combination with Corning’s glass science and precision forming capabilities helped deliver an exceptional glass packaging solution for injectable drugs in vials and cartridges. The companies’ continued collaborations will focus on additional evaluations and the deployment of this new innovation. Corning Valor Glass packaging offers superior chemical durability, strength and damage resistance. These qualities enable increased throughput and more reliable access to state-of-the-art medicines for patients, while maintaining a high level of quality assurance for pharmaceutical companies. As a result of Merck and Pfizer’s commitment to improving glass quality and promising results from their initial testing, Corning is making an initial investment of $500 million and creating 1,000 new US jobs as the first part of a planned investment of $4 billion and 4,000 new high-tech jobs. ]]> <![CDATA[LEO Pharma gets EC nod for its first and only biologic Kyntheum that targets the IL-17 receptor]]> https://biospectrumindia.com/news/95/9315/leo-pharma-gets-ec-nod-for-its-first-and-only-biologic-kyntheum-that-targets-the-il-17-receptor.html https://biospectrumindia.com/news/95/9315/leo-pharma-gets-ec-nod-for-its-first-and-only-biologic-kyntheum-that-targets-the-il-17-receptor.html Wed, 26 Jul 2017 14:35:00 +0530 LEO Pharma announced that the European Commission has granted marketing authorization for Kyntheum (brodalumab), a new biologic for the treatment of moderate-to-severe plaque psoriasis in adults within the European Union who are candidates for systemic therapy. Kyntheum is the first and only biologic that selectively targets the IL-17 receptor subunit A. Psoriasis is a common, chronic, immune-mediated, inflammatory disease affecting an estimated 125 million people worldwide, including nearly 14 million Europeans.  It primarily affects the skin, but carries with it a substantial social and psychological burden, even when a relatively small proportion of body surface is affected. Kyntheum is different from existing therapies. By specifically binding to the receptor on skin cells rather than targeting free floating inflammatory mediators, brodalumab blocks the biological activity of several pro-inflammatory IL-17 cytokines involved in psoriasis plaque formation. “Lasting skin clearance is our ultimate treatment goal for psoriasis patients, as it has such a significant impact on an individual’s wider wellbeing, along with their physical health. Experiencing clear skin brings a huge benefit to patients. Results from the AMAGINE trials show that Kyntheum has the potential to virtually clear psoriasis in almost 80% of patients, often within just three months*, establishing its approval as a major advancement within the field of psoriasis” commented Professor Dr. Ulrich Mrowietz, Psoriasis Centre, University Medical Centre, Schleswig-Holstein, Germany in a release. The AMAGINE trials - AMAGINE-1-3 - involved 4,373 patients with moderate-to-severe psoriasis,   the largest study population in the development program of any new biologic treatment in psoriasis to date. All three trials evaluated the efficacy and safety of different doses of Kyntheum compared to placebo and AMAGINE-2 and -3 also compared Kyntheum to ustekinumab. Kyntheum was well tolerated in all trials with an acceptable safety profile.  Although cases of suicidal ideation and behaviour were reported, no causal association between treatment with Kyntheum and increased risk of suicidal ideation and behavior has been established. Its launch in Europe will be supported by post-marketing pharmacovigilance activities to capture and follow up on any reports of safety events. Gitte Pugholm Aabo, President and CEO of LEO Pharma, said: “Those most affected by psoriasis often feel controlled by their condition, the stigma it brings, and the diverse complications associated with it. We hope that the EU approval of Kyntheum will help many more people to regain control, and live lives unrestricted by psoriasis, while our role is to support them throughout their journey to clear skin.” Brodalumab is currently approved in the U.S. and Japan for adult patients with moderate-to-severe plaque psoriasis. In Japan, it is also approved for psoriasis vulgaris, psoriatic arthritis, pustular psoriasis and psoriatic erythroderma.     ]]> <![CDATA[Cipla launches Rectal Artesunate Suppositories for severe malaria in young children]]> https://biospectrumindia.com/news/95/9312/cipla-launches-rectal-artesunate-suppositories-for-severe-malaria-in-young-children.html https://biospectrumindia.com/news/95/9312/cipla-launches-rectal-artesunate-suppositories-for-severe-malaria-in-young-children.html Wed, 26 Jul 2017 14:15:00 +0530 Cipla Ltd. and the product development partnership Medicines for Malaria Venture (MMV) recently announced the launch of 100 mg Artesunate Rectocaps/Rectal Artesunate Suppositories (RAS) which is considered as a life-saving, pre-referral intervention for the management of severe malaria in young children making it the first quality-assured RAS product. Initially developed by the World Health Organization's (WHO) Tropical Diseases Research programme, RAS 100 mg manufactured by Cipla was recently added to the Global Fund Expert Review Panel’s list of quality-assured medicines, while the process of WHO prequalification of this medicine moves through its final stages. Umang Vohra, MD and Global CEO Cipla Ltd. said, “Cipla is committed to providing access to affordable medicines. Our endeavour is to make RAS 100 mg available in rural areas in Africa and to national community health programmes, notably with the support of international donors that have already pledged to procure Rectal Artesunate.” Dr David Reddy, MMV’s CEO said, “MMV welcomes this excellent news. RAS is a life-saving intervention. With the launch of Cipla’s product, the first to be quality-assured, more malariaendemic countries will now be able to provide it to more of their children. We are proud to have worked with Cipla in its quest to ensure universal access to high quality and affordable treatments, especially for vulnerable young populations suffering from severe malaria.” Cipla’s RAS product contains 100 mg of Artesunate and is indicated in children from 6 months to 6 years. It was developed with the support of MMV (with UNITAID financing) and will now soon be available in four sub-Saharan countries. ]]> <![CDATA[Merck wins tentative U.S. FDA approval for Lusduna]]> https://biospectrumindia.com/news/95/9313/merck-wins-tentative-u-s-fda-approval-for-lusduna.html https://biospectrumindia.com/news/95/9313/merck-wins-tentative-u-s-fda-approval-for-lusduna.html Wed, 26 Jul 2017 13:55:00 +0530 Merck announced in a press release that the U.S. Food and Drug Administration (FDA) has granted tentative approval for LUSDUNA Nexvue (insulin glargine injection) 100 units/mL, a follow-on biologic basal insulin in a pre-filled dosing device. LUSDUNA Nexvue is being developed by Merck with funding from Samsung Bioepis. With the tentative approval, LUSDUNA Nexvue has met all required regulatory standards for follow-on biologics of clinical and nonclinical safety, efficacy and quality, but is subject to an automatic stay due to a lawsuit from Sanofi claiming patent infringement. Under the Hatch-Waxman Act, the initiation of Sanofi’s lawsuit in September 2016 automatically invoked a stay on final FDA approval of LUSDUNA Nexvue for a period of up to 30 months, or in the event a court finds in favor of Merck, whichever comes sooner. “The tentative approval of LUSDUNA Nexvue is an important milestone, bringing us closer to offering this medicine to patients,” said Sam Engel, M.D., associate vice president, Merck clinical research, diabetes, endocrinology and women’s health. The trade name “LUSDUNA Nexvue” was granted provisional approval by the FDA and will be used in the U.S. when the product is made available. Merck, a leading global biopharmaceutical company known as MSD outside of the United States and Canada, has been inventing for life, bringing forward medicines and vaccines for many of the world’s most challenging diseases. Through its prescription medicines, vaccines, biologic therapies and animal health products, it works with customers and operates in more than 140 countries to deliver innovative health solutions. It also demonstrates their commitment to increasing access to health care through far-reaching policies, programs and partnerships. Today, Merck continues to be at the forefront of research to advance the prevention and treatment of diseases that threaten people and communities around the world including cancer, cardio-metabolic diseases, emerging animal diseases, Alzheimer’s disease and infectious diseases including HIV and Ebola.     ]]> <![CDATA[Lupin receives FDA approval for Fluocinonide Topical Solution]]> https://biospectrumindia.com/news/95/9310/lupin-receives-fda-approval-for-fluocinonide-topical-solution.html https://biospectrumindia.com/news/95/9310/lupin-receives-fda-approval-for-fluocinonide-topical-solution.html Wed, 26 Jul 2017 12:40:00 +0530 Pharma Major Lupin Limited recently announced that it has received final approval for its Fluocinonide Topical Solution USP, 0.05% from the United States Food and Drug Administration (FDA) to market a generic version of County Line Pharmaceuticals, LLC’s Fluocinonide Topical Solution USP, 0.05%. Lupin’s Fluocinonide Topical Solution USP, 0.05% is AT rated generic equivalent of County Line Pharmaceuticals, LLC’s Fluocinonide Topical Solution USP, 0.05%. It is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. ]]> <![CDATA[Piramal Enterprises Wins Gold at LACP Vision Awards ]]> https://biospectrumindia.com/news/95/9293/piramal-enterprises-wins-gold-at-lacp-vision-awards-.html https://biospectrumindia.com/news/95/9293/piramal-enterprises-wins-gold-at-lacp-vision-awards-.html Fri, 21 Jul 2017 16:40:00 +0530 Piramal Enterprises Limited has won the Gold Award in ‘Conglomerates, Holding Companies, Diversified Interest’ category at the 2016 Vision Awards Annual Report Competition, held by the League of American Communications Professionals (LACP). The Annual Report earned 98 out of 100 points. The awards benchmarks and recognises best practices in international financial reporting. Vijay Shah, Executive Director, Piramal Enterprises Limited, said: “We are delighted that Piramal’s Annual Report was recognised at the 2016 Vision Awards, alongside some of the best international companies. This award is a testament to the performance of our teams, and will continue to encourage to improve the quality and transparency of our disclosures, enabling investors to make informed decisions.” Developed under the theme of ‘Transforming Consistently. Delivering Value,’ the annual report demonstrated the Company’s ability to continuously transform, evolve and create positive changes by discovering new or revised business models, based on a vision for the future. The 2016 Vision Awards Annual Report Competition drew one of the largest number of submissions ever, representing a broad range of industries and organisational sizes. Nearly 1,000 entries were accepted in this year’s competition. The League of American Communications Professionals LLC (LACP) is an association established in 2001 in order to create a forum within the public relations industry that facilitates discussion of bestin-class global practices within the profession while also recognising those who demonstrate exemplary communications capabilities. ]]> <![CDATA[TRAC and MedGenome announces a Cancer Immunotherapy solution to India]]> https://biospectrumindia.com/news/95/9290/trac-and-medgenome-announces-a-cancer-immunotherapy-solution-to-india.html https://biospectrumindia.com/news/95/9290/trac-and-medgenome-announces-a-cancer-immunotherapy-solution-to-india.html Fri, 21 Jul 2017 16:05:00 +0530 Toronto Recombinant Antibody Centre (TRAC) from the University of Toronto, Canada have agreed to license MedGenome’s patented cancer immunotherapy solution OncoPept for the development of biomarkers for their drug candidates against immune modulators to treat cancer. The licensing will form the basis of a larger partnership between the two organizations that can be leveraged to bring novel antibody drugs to the Indian market. India adds over one million new cancer cases every year with greater than 60% mortality due to lack of effective therapies. Highly effective antibody drugs take years before they become available in India, and when available, have limited market uptake because of the price barrier. For example, the cost of treatment for the new cancer immunotherapy drugs can be as high as Rs One crore for a year of therapy. This provides a great opportunity for the Indian pharma companies to take advantage from the partnership between MedGenome and TRAC to bring new cancer immunotherapy drugs to the Indian market at affordable prices and further enhance the effectiveness of therapy by using the OncoPept platform to identify patients who will benefit maximally from the treatment.  Sam Santhosh, Founder of MedGenome, said “TRAC has the best platform in the world for producing novel biologics. We are proud to partner with them by providing our OncoPept solution which can also help Pharmaceutical companies select the right patients for their clinical trials.” Dr. Sachdev Sidhu, Professor at University of Toronto said, “MedGenome’s pipeline to dissect the tumor microenvironment at a molecular level will help in identifying new targets for which novel antibodies can be made. MedGenome’s unique knowledge in analyzing diseases at a population level through its research arm in India provides an unprecedented opportunity to create drugs that can be more effective in certain population groups.” ]]> <![CDATA[HITES signs MoU with KITCO for healthcare projects]]> https://biospectrumindia.com/news/95/9282/hites-signs-mou-with-kitco-for-healthcare-projects.html https://biospectrumindia.com/news/95/9282/hites-signs-mou-with-kitco-for-healthcare-projects.html Wed, 19 Jul 2017 12:30:00 +0530 HLL Infra Tech Services Ltd (HITES), has signed a MoU with KITCO, a premier engineering, management and project consultancy firm, for strategic alliance to jointly undertake execution of healthcare infrastructure projects using their competencies. Under the MOU, HITES can utilize the services of city-based KITCO for engineering designs. KITCO, on its part, may utilize HITES's capability for PMC (Project Management Consultant) services, procurement of medical equipment, BME (biomedical engineering) services and facility management. HITES, a fully owned subsidiary of HLL, a central PSU of the Health & Family Welfare Ministry, is mandated to provide consultancy services such as infrastructure development, facility management, procurement and allied services. KITCO, a PSU company, has expertise in planning and implementation of projects in health infrastructure also. The company has a panel of architects, doctors, health planners, procurement engineers and a network of consultants specialized in different fields of healthcare. HITES, the executing agency of the Union Health and Family Welfare Ministry and several state governments, is India's only comprehensive healthcare service provider.  Apart from facility management, it has three more verticals: Infrastructure Development, Procurement and Consultancy and Biomedical Services. ]]> <![CDATA[Alembic Pharma opens anti-cancer drug unit in Gujarat ]]> https://biospectrumindia.com/news/95/9265/alembic-pharma-opens-anti-cancer-drug-unit-in-gujarat-.html https://biospectrumindia.com/news/95/9265/alembic-pharma-opens-anti-cancer-drug-unit-in-gujarat-.html Mon, 17 Jul 2017 15:15:00 +0530 Drug firm Alembic Pharmaceuticals Ltd has entered into oncology segment by inaugurating a Rs 300 crore anti-cancer drug facility at Halol in Gujarat. The unit will manufacture 60 million tablets or capsules and approximately 20 million vials of liquid injectable and lyophilized concentrates. With this facility, the Alembic Pharma will commence exporting oncology products to US, Middle East, North Africa, Australia and South Africa. The facility has equipment from BOSCH of Germany, GEA of Belgium, Alexanderwerk from UK, ICOS from Italy, Tofflon from China. The company hopes to invest Rs 1,500 crore as part of its expansion plan over the next three years period, which will be funded through debt and internal accruals. APL has recently invested in an ultra-modern R&D centre at Hyderabad. APL is one of the leading players in the industry to have invested about 11 per cent of its turnover in R&D. The Gujarat state government hopes to launch 1,000 generic medical stores in 2017 from the present 250 stores, which will help in providing cheap quality drugs to people of the state ]]> <![CDATA[Piramal planning to expand Pharma Vertical Presence in US, Europe]]> https://biospectrumindia.com/news/95/9259/piramal-planning-to-expand-pharma-vertical-presence-in-us-europe.html https://biospectrumindia.com/news/95/9259/piramal-planning-to-expand-pharma-vertical-presence-in-us-europe.html Fri, 14 Jul 2017 16:55:00 +0530 Piramal Enterprises has said it is looking to expand presence of its pharma vertical in global markets such as the US, Europe and Japan with plans to introduce more products going forward. North America and Europe account for over 70 per cent of the company's revenue from pharmaceuticals business. Piramal Enterprises said in its annual report for 2016-17 said, "Piramal will continue to add more generic hospital products both organically and inorganically to leverage its strong sales and distribution network, integrating acquired products and generating synergies. Piramal continues to strengthen its distribution presence in key European countries like the UK, Italy, Germany, and others” On geographical expansion, the reports said the company would "further expand presence in strong markets, including the US, Europe and Japan." Piramal's pharma vertical is divided into two -the global pharma business that sells pharma products and services globally and the India consumer products business that sells OTC products in India. The company has its own field force in the US, the UK, Italy, and Germany and through more than 80 business partners in other countries along with distribution presence in over 110 countries across the world. ]]> <![CDATA[Zydus Cadila's anti-diabetic drug gets USFDA marketing nod]]> https://biospectrumindia.com/news/95/9257/zydus-cadilas-anti-diabetic-drug-gets-usfda-marketing-nod.html https://biospectrumindia.com/news/95/9257/zydus-cadilas-anti-diabetic-drug-gets-usfda-marketing-nod.html Fri, 14 Jul 2017 16:50:00 +0530 The company has received tentative approval from the United States Food and Drug Administration (USFDA) to market sitagliptin and metformin hydrochloride in the strength of 50mg/500 mg and 50mg/1000 mg The approved drug is a fixed dose combination of two anti-diabetic drugs indicated for type II diabetes and will be produced at the group's formulation manufacturing facility at the pharma SEZ in Ahmedabad. The group now has nearly 120 approvals from the USFDA and so far filed 300 abbreviated new drug applications (ANDAs),Cadila Healthcare said.   ]]> <![CDATA[Cipla to explore marketing tie-up with Novartis]]> https://biospectrumindia.com/news/95/9258/cipla-to-explore-marketing-tie-up-with-novartis.html https://biospectrumindia.com/news/95/9258/cipla-to-explore-marketing-tie-up-with-novartis.html Fri, 14 Jul 2017 16:50:00 +0530 Cipla, India’s third largest drug maker, and Swiss giant Novartis are in early-stage discussions to jointly market asthma drug Xolair, just months after they ended a legal battle over another respiratory drug. Xolair (omalizumab) is an injectable prescription medicine used to treat moderate to severe persistent asthma in patients whose symptoms are not controlled by inhaled corticosteroids. Marketing arrangement and tie-ups between companies are common and often formed to leverage each other’s distribution networks. Cipla, one of the oldest domestic pharmaceutical companies, is strong in India’s Rs 8,500 crore respiratory drug market, with a well-entrenched distribution network that would be hard to replicate. Novartis has been looking at licensing out its respiratory portfolio, which has lost sheen globally in the past few years. Indian generic drug makers such as Lupin, Cipla, Zydus Cadila and Sun Pharmaceutical Industries are eyeing the respiratory drug portfolio that the Swiss giant is seeking to divest. ]]> <![CDATA[Piramal plans expansion in US and Europe]]> https://biospectrumindia.com/news/95/9243/piramal-plans-expansion-in-us-and-europe.html https://biospectrumindia.com/news/95/9243/piramal-plans-expansion-in-us-and-europe.html Wed, 12 Jul 2017 13:30:00 +0530 Piramal Enterprises is looking to expand presence of its pharma vertical in global markets such as the US, Europe and Japan with plans to introduce more products going forward. North America and Europe account for over 70 per cent of the company's revenue from pharmaceuticals business. Piramal's pharma vertical is divided into two- the global pharma business that sells pharma products and services globally and the India consumer products business that sells OTC products in India. The company operates through its own field force in the US, the UK, Italy, and Germany and through more than 80 business partners in other countries. It has distribution presence in over 110 countries across the world. It has four plants in North America and two plants in the UK and has dedicated sales force in North America and Europe. In the US it has 30 per cent market share in inhalation anaesthesia. In the current fiscal, the company plans to launch Desflurane, the latest generation of inhalation anaesthesia. ]]> <![CDATA[GE Healthcare partners with Oritain to introduce confirmatory test for country of origin of fetal bovine serum]]> https://biospectrumindia.com/news/95/9230/ge-healthcare-partners-with-oritain-to-introduce-confirmatory-test-for-country-of-origin-of-fetal-bovine-serum.html https://biospectrumindia.com/news/95/9230/ge-healthcare-partners-with-oritain-to-introduce-confirmatory-test-for-country-of-origin-of-fetal-bovine-serum.html Tue, 11 Jul 2017 16:05:00 +0530 GE Healthcare and Oritain are today launching an independent test-based traceability program to authenticate the country of origin of Fetal Bovine Serum (FBS). FBS is a cell growth supplement used in the manufacturing of biopharmaceuticals and vaccines for human health and veterinary purposes, as well as in basic research and drug discovery.  Serum plays an important role in the cell-based production of high-quality vaccines and therapeutics for people and animals around the world. Morgan Norris, General Manager for Upstream and Cell Culture, GE Healthcare Life Sciences said, “The country of origin is important - especially when FBS is used in biomanufacturing. Different countries of origin present different risk levels for a range of virus contamination, and using serum that we know to be from low-risk countries is a top priority for our clients” “FBS is used to manufacture vaccines that protect people from a variety disease. We want to ensure that our customers can access high-quality products with the lowest risk possible when producing their vaccines and biopharmaceuticals.  This test-based traceability is another tool we have to assure this. By partnering with Oritain, we are committing to supply our customers with products of exceptional quality and integrity,” he added GE Healthcare is already traceability-certified by the International Serum Industry Association (ISIA), but to ensure that premium raw serum from Australia, New Zealand and the United States is indeed from that country of origin, GE will now put its sera products through a testing process that goes beyond industry-standard traceability practices. Grant Cochrane, CEO, Oritain said, “Oritain’s Scientific Traceability method is unique in the fact that it does not rely on paper or labels, but rather authenticates the origin of the product itself. Scientific Traceability measures the naturally-occurring chemical elements that exist within the serum itself as a result of the particular environment the cows are being raised in. With FBS samples obtained from GE manufacturing sites all over the world, we have analyzed each one to create a unique fingerprint of origin for sera that comes from the USA, Australia and New Zealand” “This cannot be changed or tampered with in any way without detection, as we are dealing with concentrations in the parts per million across more than 20 different variables. We are delighted to be providing proof of origin services for these GE Healthcare products that are making the world a safer and healthier place.  Oritain’s country of origin verification service for FBS products means greater authenticity and trust for GE’s clients, as it minimizes the likelihood of product fraud or counterfeiting in the supply chain in high-risk countries,” he added ]]> <![CDATA[Shanchol by Shantha Biotechnics’s completes milestone of delivering 10 million cholera doses]]> https://biospectrumindia.com/news/95/9228/shanchol-by-shantha-biotechnicss-completes-milestone-of-delivering-10-million-cholera-doses.html https://biospectrumindia.com/news/95/9228/shanchol-by-shantha-biotechnicss-completes-milestone-of-delivering-10-million-cholera-doses.html Mon, 10 Jul 2017 16:40:00 +0530 Hyderabad based affiliate of Sanofi Pasteur, Shantha Biotechnics announced its milestone achievement of having delivered 10 million doses of its cholera vaccine, Shanchol. The vaccine received the World Health Organization (WHO) pre-qualification in 2011 and since then, the product has been shipped to 25 countries across the world.  Shanchol is a ready to use oral cholera vaccine adapted to endemic settings. It consists of killed whole cells from a mix of pathogenic strains of the cholera bacterium Vibrio cholerae (O1 and O139) and is administered in two doses, one to six weeks apart. It is a fast-acting vaccine (7 to 10 days) and provides long-lasting protection for up to 5 years from the time of administration. Dr. Shailesh Ayyangar, Managing Director - India and Vice President - South Asia, Sanofi said, “We estimate that the 10 million doses of Shanchol™ could potentially have saved close to five million people – especially those living in high-risk, endemic areas from cholera. Since 2013, Shantha Biotechnics’s impact on public health through the supply of oral cholera vaccine to WHO has contributed significantly to global cholera control.”  Dr. Mahesh Bhalgat, Executive Director and Chief Operating Officer, Shantha Biotechnics said, “There were many occasions when the time to deliver the vaccines was very short. In October 2016, the WHO asked Shantha Biotechnics to deliver 510,000 doses of Shanchol™ to Iraq. The Ministry of Health in Iraq wanted to launch a major vaccination campaign to combat a cholera outbreak situation. This was the single biggest shipment of cholera vaccine which Shantha delivered within eleven days.”     ]]> <![CDATA[GNH India clears audit to trade orphan drugs]]> https://biospectrumindia.com/news/95/9227/gnh-india-clears-audit-to-trade-orphan-drugs.html https://biospectrumindia.com/news/95/9227/gnh-india-clears-audit-to-trade-orphan-drugs.html Mon, 10 Jul 2017 12:45:00 +0530 A global source for priority pharmaceuticals, GNH India is amongst the handful of Indian companies to clear an audit from one of the largest UK pharmaceutical distribution companies. Armed with a WHO-GDP (Good Distribution Practice) certification, GNH India has entered a two-way partnership with the UK based company for the trade in life-saving drugs into their respective countries. The WHO-GDP certification ensures that procurement, purchasing, storage, distribution, transportation, repackaging, relabelling, documentation and record-keeping practices are met with stringent protocols Through this new development, accessibility to medicines for the treatment of an array of diseases is now not just plausible; but extremely possible. Orphan drugs such as Ferripox (used in the treatment of iron overload in Thalassaemia major patients), Raxone (used in the treatment of visually impaired adolescents and adults), Trientine (used to treat a rare but growing rate of Wilson’s disease) and Mitocin (a drug used to treat a range of cancers) are now available to the Indian population.  Commenting on this, Dr. Piyush Gupta, Associate Director, GNH India said, “With a change in lifestyle and increased travel abroad, India’s population has become a crucible for various diseases. Even though we have seen a marked increase in incidences of rare diseases, our pharmaceutical industry is yet to catch up in response to this growth trajectory. At GNH India, we had ensured to follow due protocol by applying and receiving the WHO-GDP certification well before hand. This has led to a high success rate in terms of clearing audits from various countries- the UK is the latest.” "When these protocols are not met, the market is flooded with pseudo or counterfeit drugs. The efficacy of such medicines is a threat to public health and safety”, he added ]]> <![CDATA[USFDA gives final approval to Bupropion Hydrochloride ER tablets by Jubilant Life Science]]> https://biospectrumindia.com/news/95/9226/usfda-gives-final-approval-to-bupropion-hydrochloride-er-tablets-by-jubilant-life-science.html https://biospectrumindia.com/news/95/9226/usfda-gives-final-approval-to-bupropion-hydrochloride-er-tablets-by-jubilant-life-science.html Mon, 10 Jul 2017 12:25:00 +0530 Jubilant life science has recently announced that it has received Abbreviated New Drug Application (ANDA) final approval for Bupropion Hydrochloride Extended-Release Tablets USP (XL), 150 mg and 300 mg, the generic version of Wellbutrin XL of Valeant, which is used for the treatment of major depressive disorder and prevention of seasonal affective disorder. This is the fourth approval the company has received from the USFDA during the current financial year. ]]> <![CDATA[Promethazine by Strides Shasun approved by USFDA]]> https://biospectrumindia.com/news/95/9187/promethazine-by-strides-shasun-approved-by-usfda.html https://biospectrumindia.com/news/95/9187/promethazine-by-strides-shasun-approved-by-usfda.html Mon, 03 Jul 2017 14:30:00 +0530 Strides Shasun has recently received an approval from the United States Food & Drug Administration (USFDA) for Promethazine Hydrochloride Tablets USP, 12.5 mg, 25 mg, and 50 mg. According to IMS data, the US market for Promethazine Hydrochloride Tablets USP, 12.5 mg, 25 mg, and 50 mg is approximately $ 17 million. The product will be manufactured at the company’s flagship facility at Bangalore and marketed by Strides Pharma Inc. in the US Market. Promethazine Hydrochloride Tablet is used to prevent and treat nausea and vomiting related to certain conditions and also to treat allergy symptoms such as rash, itching, and runny nose.   ]]> <![CDATA[Leucine Rich Bio collaborates with Vittarthaa]]> https://biospectrumindia.com/news/95/9167/leucine-rich-bio-collaborates-with-vittarthaa.html https://biospectrumindia.com/news/95/9167/leucine-rich-bio-collaborates-with-vittarthaa.html Thu, 29 Jun 2017 12:05:00 +0530 Leucine Rich Bio, a genomics company, has partnered with Vittarthaa Life Sciences, a drug discovery and development company, focusing on identifying unmet clinical needs to develop pharmaceutical molecules.  The Bengaluru-based Leucine has developed analysis and interpretation pipelines for next generation sequencing and microarray data. Apart from that, the company has provided customized meta-analysis of publicly available data to cater to its client base which is spread across the globe. With strong systems biology, molecular biology and genomics background, the company can provide an umbrella of bio-informatics and other data solutions to its clients.  For Vittartha, all research programs are based on integrated approach towards target-based discovery strategies and phenotypic screening for end-point evaluation. It is also focused on innovative discovery and development approaches for progressing molecules into market. The discovery programme devises multi-parametric, phenotypic panel assay screening efficacy that are target based and de-risk toxicity at early stages. The company engages the customer at early stages of drug development providing suitable platforms for mapping the molecular mechanisms that enable to create program objective, target product profile and outline milestones decisions. Both the companies have announced collaboration in order to provide pharmaceutical, nutraceuticals and biotechnology companies a combined portfolio of research solutions under one platform. ]]> <![CDATA[NATCO receives FDA approval for Vidaza for USA market]]> https://biospectrumindia.com/news/95/9162/natco-receives-fda-approval-for-vidaza-for-usa-market.html https://biospectrumindia.com/news/95/9162/natco-receives-fda-approval-for-vidaza-for-usa-market.html Wed, 28 Jun 2017 12:55:00 +0530 Natco pharma limited has announced the final approval for Abbreviated New Drug Application (ANDA) from the U.S. Food and Drug Administration (FDA) for Azacitidine for Injection, a generic version of Vidaza by Celgene Corporation. Vidaza is anti-cancer chemotherapy drug that is used for myelodysplastic syndrome (MDS). Vidaza generated total combined sales of $188 million for the twelve-month period ending April, 2017, based on industry sales data. According to the notification given on company’s website, “NATCO and its marketing partner Breckenridge Pharmaceutical, Inc. (BPI) plan to launch this product in the USA market in the near future” ]]> <![CDATA[Takeda collaborates with Biological E]]> https://biospectrumindia.com/news/95/9155/takeda-collaborates-with-biological-e.html https://biospectrumindia.com/news/95/9155/takeda-collaborates-with-biological-e.html Tue, 27 Jun 2017 12:35:00 +0530 Japan’s Takeda and Biological E. Ltd. have agreed to collaborate on affordable combination vaccines. Takeda will transfer its measles and acellular pertussis vaccine bulk production technology to BE under license. It would also provide support for production and quality control and technical assistance in pre-clinical study design and production of clinical and first commercial batches. BE gets the rights to use Takeda’s measles and pertussis vaccine technologies for combinations such as MR vaccine as well as any pertussis-containing combination, and will be solely responsible for conducting and funding the development activities. BE will commercialise the vaccines in markets including India and China. The tie-up gives BE an opportunity to diversify its geographic reach. The company is looking forward to contributing to the measles elimination goals and protection against rubella. Biological E limited is a privately held biopharmaceutical company based in Hyderabad, Telangana, India. It specialises in the areas of low-cost vaccine production. ]]> <![CDATA[Novartis chalks its new programme to combat noncommunicable diseases ]]> https://biospectrumindia.com/interviews/95/9153/novartis-chalks-its-new-programme-to-combat-noncommunicable-diseases-.html https://biospectrumindia.com/interviews/95/9153/novartis-chalks-its-new-programme-to-combat-noncommunicable-diseases-.html Mon, 26 Jun 2017 14:00:00 +0530 Novartis chalks its new programme to combat with noncommunicable diseases Recently noncommunicable diseases have developed a stout web across the globe. Especially, diseases such as cardiovascular diseases (CVD), diabetes, chronic obstructive pulmonary diseases (COPD) and cancers are very common among this growing global population. The rates of these diseases are very high in developing nations and it is expected that due to lack of treatment available in these nations, this rate will increase further.  The World Health Organization (WHO) estimates that by 2020, NCDs will account for 80 per cent of the global burden of disease, causing seven out of every 10 deaths in developing countries, about half of them premature deaths under the age of 70. According to WHO, it is estimated that the global NCD burden will increase by 17 per cent in the next ten years, and in the African region by 27 per cent. Almost half of all deaths in Asia are now attributable to NCDs, accounting for 47 per cent of global burden of disease. In order to curb the rate of the noncommunicable diseases and to provide high quality medicines to developing nations, Novartis has chalked down a new programme called ‘Novartis Access Programme’. Under this programme, a portfolio of 15 medicines to treat chronic diseases in low- and low-middle-income countries has been created. The portfolio addresses cardiovascular diseases, diabetes, respiratory illnesses, and breast cancer and will be offered to governments, non-governmental organizations (NGOs) and other public-sector healthcare providers for US$ one per treatment, per month. To put more light on the programme, Harald Nusser, Head of Novartis Social Business which runs the Novartis Access programme, spoke to Biospectrum in an exclusive interview. How was the whole idea of Novartis Access conceived?  We announced the launch of Novartis Access in September 2015 in New York. We want to be part of the solution to the growing problem of noncommunicable diseases (NCDs) in lower-income countries.   We often think of these illnesses – conditions such as diabetes, cardiovascular diseases, respiratory illnesses, and cancer – as being more prevalent in higher-income countries. In fact, NCDs are a major threat to populations in developing countries and to their future economic, social, and health development.  By 2020, we’ll see NCDs making up 80 per cent of the global burden of disease. In the same year, the WHO predicts that NCDs will be responsible for 44 million deaths worldwide. Seven out of every ten of these deaths will be in developing countries – and half of these will be before the age of 70.2 That gives us an idea of the sheer magnitude of the NCD threat with regards to economic development – as premature deaths and rising disability lead to a huge loss of productivity.  All in all, it is expected that by 2030, the global cost of NCDs will be USD 47 trillion. That’s more than double the current national debt of the United States – and it’s a cost developing countries and people in those countries will be most impacted by.  Can you explain the working of the Novartis Access program? The Novartis Access program provides a portfolio of fifteen treatments against the four main types of NCDs – cardiovascular diseases, type 2 diabetes, respiratory illnesses and breast cancer. It also offers one treatment against an infectious disease, childhood pneumonia, which we had previously developed to respond to a request from UNICEF. These treatments, both on- and off-patent medications, are provided to governments at national and local levels at a cost of USD 1 per treatment per month. To ensure the treatments get to the people who need them when they need them, we are working with partners on the ground to improve the supply chain. Managing chronic conditions often means that people have to take medications on a daily basis for a long time, sometimes even their whole life. They need to be able to access these treatments even in remote rural areas. We are also taking steps to ensure that middlemen do not excessively mark up the very low prices we have set, to ensure medicines remain affordable to the end user. Beyond the medicines, we also work with partners to train healthcare professionals and community health workers (CHWs). CHWs have been very effective in the fight against infectious diseases and they can have a similar, vital role in the fight against chronic diseases, as long as they have the appropriate training. We are already working with governments and NGOs to build capacity, and will continue to work with them on it. Your company has been running this program in many countries that are not well equipped to provide high quality medical services to its citizens, do you think that this program can act as a breather for such countries, if yes, How?  So far we’ve only rolled out Novartis Access fully in Kenya. However, we have signed agreements with other African countries, such as Ethiopia and Rwanda, to implement the program there, and we’ve recently signed a Memorandum of Understanding with Pakistan.  Our program can certainly be useful to governments and other institutions delivering care for NCDs. However, it is not our role to create a healthcare system for these countries as it is the responsibility of governments to invest in healthcare, particularly primary care. How do you see Asian countries, especially when it comes to health issues, do you think that these countries need more attention in areas such as good quality medicines, treatment, technological advancements in the healthcare sector, etc.?  First, we should address NCDs in Asia by educating people about making the right lifestyle choices. We see a lot of people in Asian countries – particularly those countries showing a rate of rapid economic development, such as India and China – pursuing more sedentary lifestyles. People are exercising less, and getting into unhealthy eating and smoking habits. These trends need to be reversed to reduce their future burden of chronic diseases.  Second, there’s great potential for making care for NCDs more accessible and affordable. As a world leader in low-cost generic medicines, and more affordable diagnostics, India is leading the way in driving down healthcare costs.[i] [ii] But it is important to note that the most important element in delivering care is a robust and well-funded primary care system. Technology can help but it is no substitute for healthcare professionals and good-quality health infrastructure. You have recently tied up with the Government of Pakistan under your Novartis Access program, can you elaborate on that?  Novartis recently signed a Memorandum of Understanding with the Pakistani government to implement Novartis Access there. In Pakistan, around half of the population suffer from some form of chronic disease, and around 2,000 Pakistanis die from a preventable NCD every day – with many of these deaths being premature[iii].   We will initially roll out Novartis Access through federal hospitals, under the Prime Minister’s National Health Insurance Program. We are looking to extending the program to the public health system on a provincial level, as healthcare is the responsibility of provincial governments in Pakistan.  We are hoping Novartis Access will enable millions of Pakistani people to access vital treatment for NCDs.  India is a very diverse country which is mostly dominated by middle-class families, so how do you are planning to web your network here?  India does indeed have a large middle class, but the country also has many impoverished families, especially in rural areas. India actually has the largest number of people living below the poverty line in the world[iv]. At the same time, its economy is one of the world’s largest. These contrasts make India a uniquely challenging country to implement a program like Novartis Access.  Our priority at the moment in India is Arogya Parivar, our Healthy Family initiative. This program focuses on issues such as health education, disease awareness and access to diagnosis. We’ve enjoyed a lot of success with Arogya Parivar since implementing it in 2007, both as a social business model and as a public health tool. We are currently exploring ways of integrating Novartis Access products against NCDs into the program. Apart from India and Pakistan, which all Asian countries you are focusing on? We are running our Healthy Family program in Vietnam[v]. We’re making use of public-private partnerships, collaborating with provincial health authorities to provide services in the fields of health awareness and education, as well as expanding access to diagnosis and treatment. Novartis also signed a broad memorandum of understanding with the government in Vietnam, which covers NCD interventions such as Novartis Access, and we are currently waiting for the portfolio to be registered. We are also in discussions with several other Asian countries regarding their potential interest in Novartis Access.                 ]]> <![CDATA[Leo Pharma invests into Novopyxis]]> https://biospectrumindia.com/news/95/9140/leo-pharma-invests-into-novopyxis.html https://biospectrumindia.com/news/95/9140/leo-pharma-invests-into-novopyxis.html Thu, 22 Jun 2017 14:40:00 +0530 Leo Pharma announced an investment in the biotechnology company Novopyxis to support the development of an early-stage drug delivery device designed to increase the penetration of topical treatments in the skin. The hand-held aerosol device will be clinically tested on people with alopecia, where there is a high need for alternative treatment options to painful steroid injections. Alopecia is an autoimmune disease leading to hair loss from all or some parts of the body, usually the scalp. Under the agreement, Leo Pharma will make an investment that enables validation of the technology in a clinical study in alopecia patients. Leo Pharma has exclusive rights to license the technology in dermatological indications through an option agreement. The agreement demonstrates Leo Pharma’s ongoing commitment to driving innovation through partnering, acquisitions and investments. Leo Pharma has an open and agile approach to business development, supported by internal R&D and a network of dedicated innovation units. Leo Pharma actively seeks partnering and investment opportunities with the potential to improve dermatology care, including in rare skin diseases. This is the first Leo Pharma R&D agreement to be sourced from the Leo Science & Tech Hub in Boston. ]]> <![CDATA[Glenmark starts a pact with APC Therapeutics]]> https://biospectrumindia.com/news/95/9133/glenmark-starts-a-pact-with-apc-therapeutics.html https://biospectrumindia.com/news/95/9133/glenmark-starts-a-pact-with-apc-therapeutics.html Wed, 21 Jun 2017 14:45:00 +0530 Domestic pharma major Glenmark Pharmaceuticals has entered into a licensing agreement with Boston-based APC Therapeutics Inc for development of a potential cancer treatment drug. Under the terms of the agreement, Glenmark will license the product from APC Therapeutics and manage all clinical development, including regulatory filings and commercialisation worldwide. APC Therapeutics, a biopharmaceutical company which is focused on building a portfolio of immuno-oncology (IO) therapies, will receive development milestones and sales royalty payments. The oncology compound based on Antigen Presenting Cell (APC) biology has the potential to be used as a monotherapy or in combination with approved therapies to address unmet needs in cancer treatment. The mechanism of action of APC biology is very intriguing and has the potential to be transformative in cancer treatment by triggering powerful immunologic responses to tumours that may lead to deeper and more durable responses to treatment. Citing IMH Health data, Glenmark said the global oncology market is growing exponentially and projected to exceed USD 150 billion by 2020. ]]> <![CDATA[AstraZeneca India receives marketing approval for Symbicort 320]]> https://biospectrumindia.com/news/95/9124/astrazeneca-india-receives-marketing-approval-for-symbicort-320.html https://biospectrumindia.com/news/95/9124/astrazeneca-india-receives-marketing-approval-for-symbicort-320.html Tue, 20 Jun 2017 16:05:00 +0530 AstraZeneca Pharma India Limited (AstraZeneca India), an international biopharmaceutical company has received marketing authorisation from the Drug Controller General of India (DCGI) for Symbicort 20 mcg.  Symbicort 320 mcg is a fixed-dose combination drug comprising budesonide and formoterol fumarate dehydrate delivered through a special device. It is indicated for treatment of severe Asthma and for patients with moderate to severe COPD with frequent symptoms and a history of exacerbations. Symbicort is approved for use in 91 countries for the treatment of Asthma and COPD. Results from AstraZeneca’s two major clinical studies have shown that the addition of formoterol to budesonide improved asthma symptoms and lung function, and reduced exacerbation. Similarly, in two 12-month studies in patients with COPD, Symbicort was superior to placebo, formoterol and budesonide regarding lung function and showed a significant reduction in the exacerbation rate compared with placebo and formoterol. Dr. Anilda D’souza, Head –Medical Affairs & Regulatory, AstraZeneca India said, “Asthma and COPD are common and major causes of chronic morbidity impacting millions of patients in India. It is often not well controlled by existing treatments. AstraZeneca India is pleased to bring Symbicort 320 mcg, which will offer physicians and patients another treatment option for severe asthma and for moderate to severe COPD, where high dosage is required.”  Asthma is a common and chronic condition that affects the lungs’ airways. Inflammation and narrowing of the airways may cause wheezing, breathlessness, chest tightness and coughing. Symbicort, which is in the form of an inhalation powder, consists of a steroid and a long-acting beta agonist. The steroid component reduces irritation and inflammation and the beta agonist relaxes smooth muscle in the lungs and makes the airways wider, thereby decreasing symptoms. ]]> <![CDATA[FDA approval to Zydus for migraine drug]]> https://biospectrumindia.com/news/95/9118/fda-approval-to-zydus-for-migraine-drug.html https://biospectrumindia.com/news/95/9118/fda-approval-to-zydus-for-migraine-drug.html Tue, 20 Jun 2017 12:35:00 +0530 Indian pharmaceutical major Zydus Cadila has managed to receive the final approval from the US health regulator Food and Drug Administration (USFDA) to market Eletriptan Hydrobromide tablets (20 mg and 40 mg), which is used in the treatment of migraine. Following the approval, the Indian drug maker will manufacture the migraine drug which belongs to a class of drugs known as triptans in its formulations unit located at the Pharma Special Economic Zone in Ahmedabad. Manufactured by Pfizer Ireland under the brand name Relpax and available only on prescription, Eletriptan is widely used to help relieve headache, pain, and other symptoms of migraine and may allow the patient to return to their normal routine. The side-effects of the medicine include narrowing of blood vessels in the brain and impact on certain nerves in the brain. With USFDA nod, Zydus Cadila has now more than 120 approvals under its belt and has so far filed over 300 Abbreviated New Drug Applications (ANDAs) since the commencement of the filing process by the company in 2003-04. ]]> <![CDATA[Parexel collaborates with Sanofi]]> https://biospectrumindia.com/news/95/9113/parexel-collaborates-with-sanofi.html https://biospectrumindia.com/news/95/9113/parexel-collaborates-with-sanofi.html Mon, 19 Jun 2017 16:30:00 +0530 Parexel International has collaborated with Sanofi to investigate and promote the potential use of wearable devices and patient sensors to remotely collect data during clinical trials. The wearable devices are believed to address different challenges associated with clinical trials and aim to improve patient participation and interaction while creating further opportunities for decentralised trial sites. The firms intend to use their respective expertise in clinical, scientific, regulatory, logistics and technical fields to establish the use of wearables in optimising the performance of a study and expediting drug development. In an ongoing single-site study, patient data is being collected simultaneously and remotely through several wearable devices. As part of the deal, the companies are assessing the process of streamlining the data collected from various wearable devices into a single, scalable data system, which is expected to offer valuable insights. In another joint pilot study, Parexel’s patient sensor solution will be used to illustrate the scientific and medical viability of wearables. In addition to generating alerts based on the possibly large volume of time-series data from sensors, the patient sensor solution is said to securely capture, transmit, store and monitor data. ]]> <![CDATA[Exclusive marketing rights to Pfizer in Europe]]> https://biospectrumindia.com/news/95/9099/exclusive-marketing-rights-to-pfizer-in-europe.html https://biospectrumindia.com/news/95/9099/exclusive-marketing-rights-to-pfizer-in-europe.html Fri, 16 Jun 2017 15:25:00 +0530 Pfizer and Basilea Pharmaceutica, an international biopharmaceutical company specializing in the research and development of anti-infective and oncological medicines, have entered into an agreement whereby Pfizer will be granted the exclusive commercialization rights in Europe to Cresemba (isavuconazole), a novel anti-fungal treatment for adult patients with diagnosed invasive aspergillosis and mucormycosis, two serious infections associated with high morbidity and mortality among immunocompromised patients. Under the terms of the agreement, Pfizer will have exclusive rights to distribute and commercialize Cresemba in Europe, including Austria, France, Germany, Italy and the United Kingdom, where it is currently available. These rights do not extend to the Nordic countries (Denmark, Finland, Norway, Sweden, Iceland). In addition, Pfizer will be responsible for additional Cresemba launches, predominantly in Europe, which are expected throughout 2017 and 2018. Basilea will remain the marketing authorization holder for the European Union. Cresemba is an intravenous (IV) and oral azole antifungal and the active agent of the prodrug isavuconazonium sulfate. It was approved in March 2015 by the United States Food and Drug Administration (FDA) for patients 18 years of age and older in the treatment of invasive aspergillosis and invasive mucormycosis. The European centralized marketing authorization was granted in October 2015 to isavuconazole for the treatment of adult patients with invasive aspergillosis and for the treatment of adult patients with mucormycosis for whom amphotericin B is inappropriate. Isavuconazole has orphan drug designation for the approved indications in Europe and the US. Basilea currently commercializes isavuconazole as Cresemba in Austria, France, Germany, Italy, and the United Kingdom. The drug is commercialized in the US by Basilea's license partner Astellas Pharma US. Outside the US and the EU, isavuconazole is not approved for commercial use. Pfizer does not have commercialization rights to Cresemba in the United States. ]]> <![CDATA[USFDA nod for Aurobindo Pharma]]> https://biospectrumindia.com/news/95/9094/usfda-nod-for-aurobindo-pharma.html https://biospectrumindia.com/news/95/9094/usfda-nod-for-aurobindo-pharma.html Thu, 15 Jun 2017 16:10:00 +0530 Drug firm Aurobindo Pharma has received final approval from the US Food and Drug Administration (USFDA) to make oral suspension used for controlling serum phosphorus in patients with chronic kidney disease on dialysis. Sevelamer Carbonate oral suspension will be manufactured in 0.8 gm and 2.4 gm quantities. The company's drug is a therapeutic equivalent generic version of Genzyme's Renvela oral suspension. According to IMS April 2017 data, the approved product has an estimated market size of USD 140 million. Renvela is indicated for the control of hyperphosphataemia in adult patients receiving haemodialysis or peritoneal dialysis. Renvela contains sevelamer, a non-absorbed phosphate binding crosslinked polymer, free of metal and calcium. Since sevelamer binds bile acids, it may interfere with the absorption of fat soluble vitamins such as A, D, E and K. This is the 116th ANDA (including 19 tentative approvals) to be approved out of Unit VII formulation facility in Hyderabad, India used for manufacturing oral products for Aurobindo Pharma. ]]> <![CDATA[Saifee hospital achieves success in surgery with the world's smallest pacemaker]]> https://biospectrumindia.com/news/95/9092/saifee-hospital-achieves-success-in-surgery-with-the-worlds-smallest-pacemaker.html https://biospectrumindia.com/news/95/9092/saifee-hospital-achieves-success-in-surgery-with-the-worlds-smallest-pacemaker.html Thu, 15 Jun 2017 15:40:00 +0530 Saifee hospital has successfully performed a cardio surgery using a leadless pacemaker. Unlike most pacemakers that are placed in patient's chest with leads running to the heart, the leadless pacemaker consists of nano technology capsule which is implanted through the groin into the heart. This is a minimally invasive surgical procedure, reducing the patient’s pain and stress considerably. This is only the third of its kind surgery in Mumbai so far, owing to the fact that only select cardiologists in India have access to and expertise to work with this advanced pacemaker. Dr Aliasgar, Head of Department of Cardiothoracic Surgery at Saifee Hospital said, "The surgery requires special training and expertise which is not widely available in our country as yet. Besides, not many hospitals have the infrastructure like the Saifee Hospital which gives doctors a bandwidth to perform a surgery of this kind. There are very few doctors who have the authority to use the leadless pacemaker and I am glad to be one of those few. It was a successful surgery and there is nothing more important to a doctor than giving patients a better life."   Dr Yunus Loya, head, cardiology department at Saifee Hospital said, "We take immense pride in the success of this surgery at Saifee hospital, which not only required distinct training and capability, but is also a very niche procedure. The post-surgery medical investigation which is critical in such cases was also provided to the patient in the best possible way." The product permits the patients to safely undergo MRI, adjusts the heart rate automatically by sensing changes in the body, and also features estimated battery longevity of 12 years. ]]> <![CDATA[Lupin’s opoid drug gets USFDA nod]]> https://biospectrumindia.com/news/95/9081/lupins-opoid-drug-gets-usfda-nod.html https://biospectrumindia.com/news/95/9081/lupins-opoid-drug-gets-usfda-nod.html Wed, 14 Jun 2017 15:30:00 +0530 Drug firm Lupin has received final approval from the United States Food and Drug Administration (USFDA) to market its Oxycodone Hydrochloride tablets USP, in the strengths of 5 mg, 10 mg, 15 mg, 20 mg and 30 mg. The company's tablets are generic version of Mallinckrodt Inc's Roxicodone tablets.   Oxycodone hydrochloride tablets are an immediate-release oral formulation of oxycodone hydrochloride indicated for the management of moderate to severe pain where the use of an opioid analgesic is appropriate. Oxycodone hydrochloride tablets are intended for use in patients who require oral pain therapy with an opioid agonist. As with any opioid analgesic, it is critical to adjust the dosing regimen individually for each patient. The administration of oxycodone hydrochloride tablets, like all opioid analgesics, may obscure the diagnosis or clinical course in patients with acute abdominal conditions. Roxicodonet tablets had US sales of USD 344 million as per IMS MAT March 2017. ]]> <![CDATA[Pain relief gel launched by Ozone Pharmaceuticals]]> https://biospectrumindia.com/news/95/9077/pain-relief-gel-launched-by-ozone-pharmaceuticals.html https://biospectrumindia.com/news/95/9077/pain-relief-gel-launched-by-ozone-pharmaceuticals.html Tue, 13 Jun 2017 16:55:00 +0530 Aiming to tap the huge market opportunity in the growing segment of topical analgesic gels, Indian pharma major Ozone Pharmaceuticals Ltd has launched DFO 4X Gel, an advanced topical analgesic for fast relief from pain and inflammation. DFO 4X Gel has an efficacy rate of 31 per cent faster than normal gels and contains high dose of Diclofenac Diethylamine (4.64 per cent) for direct acting deep penetration of the epidermis (outer most layer of the skin). It translates into site-specific effect and instant pain and inflammation relief. Ozone, with manufacturing plants in Haryana, Himachal Pradesh and Assam, offers a diversified product portfolio range including pharmaceuticals, skin care, hair care, personal care, beauty and wellness products. Last month, the company launched a campaign named, ‘Dard Baanton Nahi, Mitao’, addressing the consumers’ common pain points such as injuries, muscle pain, sprains, etc. Since the campaign was launched, 70,000 units of Ozone DFO 4X Gel have been sold across India. The new gel is effective and safe in management of osteoarthritis pain, acute musculoskeletal pain and inflammation, sprains and strains, sciatica pain, neck pain, back pain, epicondylitis (tennis elbow), carpal tunnel syndrome, knee pain and repetitive sports injury. ]]> <![CDATA[Portea Medical expands digital health initiatives for physiotherapy with Physitrack]]> https://biospectrumindia.com/news/95/9075/portea-medical-expands-digital-health-initiatives-for-physiotherapy-with-physitrack.html https://biospectrumindia.com/news/95/9075/portea-medical-expands-digital-health-initiatives-for-physiotherapy-with-physitrack.html Tue, 13 Jun 2017 16:45:00 +0530 Portea Medical has expanded its digital health initiatives with the launch of a project in collaboration with patient engagement solution, Physitrack.  This will enable Portea Medical’s physiotherapy patients around India to access customized video-based exercise programs prescribed by Portea physiotherapists, educational content, clinical questionnaires, as well as consult with Portea physiotherapists via their smartphone, tablet or computer through the Portea App which been integrated with PhysiApp from Physitrack. Runam Mehta, Business Manager, Medical Services at Portea Medical said, “Ensuring our patients are able to heal quickly and completely in the comfort of their homes, is a key focus area for us at Portea. The collaboration with Physitrack will help in better adherence to treatment plans and translate into improved health outcomes for our patients. The integration between Portea’s EMR and Physitrack means our physiotherapists can provide remote support when required. It also ensures data integrity between the two platforms.” ”Innovation plays a key role in how Portea delivers healthcare and this partnership expands our digital health initiatives,” she added.  Marijn Kortekaas, Partner and Program Director Asia Pacific at Physitrack said, “Portea’s holistic approach around improving patient outcomes and creating a more efficient workflow for its physiotherapists is truly ground-breaking. In addition to rolling out digital home exercise provision, patient education and outcomes reporting, delivered via our integrated Telehealth feature, Portea also integrated its EMR system with Physitrack to create significant time-savings for its physiotherapists. We are very excited to be partnering with Portea on this project.” ]]> <![CDATA[Portea Medical expands digital health initiatives for physiotherapy with Physitrack]]> https://biospectrumindia.com/news/95/9076/portea-medical-expands-digital-health-initiatives-for-physiotherapy-with-physitrack.html https://biospectrumindia.com/news/95/9076/portea-medical-expands-digital-health-initiatives-for-physiotherapy-with-physitrack.html Tue, 13 Jun 2017 16:45:00 +0530 Portea Medical has expanded its digital health initiatives with the launch of a project in collaboration with patient engagement solution, Physitrack.  This will enable Portea Medical’s physiotherapy patients around India to access customized video-based exercise programs prescribed by Portea physiotherapists, educational content, clinical questionnaires, as well as consult with Portea physiotherapists via their smartphone, tablet or computer through the Portea App which been integrated with PhysiApp from Physitrack. Runam Mehta, Business Manager, Medical Services at Portea Medical said, “Ensuring our patients are able to heal quickly and completely in the comfort of their homes, is a key focus area for us at Portea. The collaboration with Physitrack will help in better adherence to treatment plans and translate into improved health outcomes for our patients. The integration between Portea’s EMR and Physitrack means our physiotherapists can provide remote support when required. It also ensures data integrity between the two platforms.” ”Innovation plays a key role in how Portea delivers healthcare and this partnership expands our digital health initiatives,” she added.  Marijn Kortekaas, Partner and Program Director Asia Pacific at Physitrack said, “Portea’s holistic approach around improving patient outcomes and creating a more efficient workflow for its physiotherapists is truly ground-breaking. In addition to rolling out digital home exercise provision, patient education and outcomes reporting, delivered via our integrated Telehealth feature, Portea also integrated its EMR system with Physitrack to create significant time-savings for its physiotherapists. We are very excited to be partnering with Portea on this project.” ]]> <![CDATA[USFDA approves Amantadine Hydrochloride by Strides Shasun]]> https://biospectrumindia.com/news/95/9065/usfda-approves-amantadine-hydrochloride-by-strides-shasun.html https://biospectrumindia.com/news/95/9065/usfda-approves-amantadine-hydrochloride-by-strides-shasun.html Mon, 12 Jun 2017 14:50:00 +0530 Amantadine Hydrochloride Capsules USP, 100 mg by pharma company Strides Shasun has been approved by United States Food & Drug Administration (USFDA). These capsules are indicated for the treatment of Parkinson’s disease and in the treatment of Shingles (Herpes Zoster) to reduce pain. According to IMS data, the US market for this product is approximately USD 25 Million with three generic players. The product will be launched immediately. Strides Shasun has four business verticals, viz., Regulated Markets, Emerging Markets, Institutional Business and Active Pharmaceutical Ingredients. ]]> <![CDATA[Clinical data on Glargine presented by Mylan and Biocon at the American Diabetes Association’s 77th Scientific Sessions]]> https://biospectrumindia.com/news/95/9060/clinical-data-on-glargine-presented-by-mylan-and-biocon-at-the-american-diabetes-associations-77th-scientific-sessions.html https://biospectrumindia.com/news/95/9060/clinical-data-on-glargine-presented-by-mylan-and-biocon-at-the-american-diabetes-associations-77th-scientific-sessions.html Mon, 12 Jun 2017 12:35:00 +0530 Mylan N.V. and Biocon Ltd. today announced the presentation of new data from the insulin glargine clinical program, including the INSTRIDE studies at the American Diabetes Association’s 77th Scientific Sessions in San Diego. The studies confirmed the efficacy, safety and immunogenicity of MYL-1501D, insulin glargine, in comparison to Lantus® in patients with Type 1 and Type 2 diabetes. Data demonstrating pharmacokinetic and pharmacodynamic equivalence also was presented.  Insulin glargine is a long-acting insulin used to treat adults with Type 2 diabetes, as well as adults and pediatric patients with Type 1 diabetes, for the control of high blood sugar. Mylan President Rajiv Malik commented, “With more than 29 million Americans living with diabetes and the cost of insulin products on the rise, there’s a clear unmet need for more-affordable treatment options for insulin glargine. We are pleased with the positive results of the INSTRIDE clinical program, which demonstrate comparable clinical efficacy and safety of our insulin glargine to Lantus. We have long been deeply committed to supporting this community and advancing treatment for patients as the leading producer of oral diabetes medications in the U.S., and now we are continuing to deliver on our mission through our insulin programs.”  Arun Chandavarkar, CEO & Joint Managing Director, Biocon, added, “We are pleased with the outcome of these global clinical studies confirming the safety, efficacy and immunogenicity of our insulin glargine in comparison to the reference product in Type 1 and Type 2 diabetes. This is an important milestone in our development of a more affordable insulin glargine and furthers our mission of enabling access by addressing the needs of diabetes patients globally.”     ]]> <![CDATA[LifeCell launch affordable NIPT in partnership with LifeCodexx AG]]> https://biospectrumindia.com/news/95/9035/lifecell-launch-affordable-nipt-in-partnership-with-lifecodexx-ag.html https://biospectrumindia.com/news/95/9035/lifecell-launch-affordable-nipt-in-partnership-with-lifecodexx-ag.html Wed, 07 Jun 2017 17:50:00 +0530 Europe based LifeCodexx AG famous for non-invasive prenatal DNA testing has announced its partnership with LifeCell which is India’s leading mother & baby preventive health care provider, to bring PrenaTesT qNIPT testing for the first time to India. This test will be serviced under LifeCell flagship brand BabyShield which is the division specialised in mother & baby diagnostic services. Mayur Abhaya, CEO and MD of Lifecell said “We are excited to bring Prenatest using qNIPT technology - the world’s most advanced NIPT technology to India that would lead to substantially lower parental anxiety, as they would be able to make better informed decisions with access to reliable and affordable test results, yet with no risk to the fetus. Our laboratory for Prenatest is being set-up and the service will be available for our customers post the month of November, this year.” Dr. Michael Lutz, CEO of LifeCodexx AG said “We are very pleased to have partnered with LifeCell since they have a long standing expertise in the field of preventive healthcare services for mother and child in the Indian market. We are certain that our qNIPT technology will find a ready market in India due to its high cost-efficiency and rapid turnaround time and also, considering that India has a birth rate of over 25 million children per year.” The qNIPT technology detects the presence of fetal trisomy 21 (Down Syndrome) from maternal blood and it received CE marking (European Conformity) in December 2016 last year. This certification was obtained after a successful blinded clinical validation of around 1000 samples, demonstrating a 100% credibility of test results obtained from PrenaTest.        ]]> <![CDATA[Lupin Pharma gets the nod from USFDA for five drugs]]> https://biospectrumindia.com/news/95/9032/lupin-pharma-gets-the-nod-from-usfda-for-five-drugs.html https://biospectrumindia.com/news/95/9032/lupin-pharma-gets-the-nod-from-usfda-for-five-drugs.html Wed, 07 Jun 2017 15:25:00 +0530 If all goes by the plan, Lupin Pharma will start exporting from its Mihan-SEZ unit by this year. In a recent move, the company has able to get approval from United States Food and Drugs Administration (USFDA) for its five drugs. It is now planning to roll out these drugs to international market during the current financial year. These are generic drugs for cardiac ailments. Lupin already makes the branded version of these drugs for the domestic market. With approval of the generic medicines, Lupin is specifically targeting the US market, said a source aware of the development. “The company wants to exploit its expertise as a generic drug maker in the export market,” said the source. So far, the company was carrying out research and development work at the Mihan plant. Now, commercial production can begin as the approvals from USFDA have been secured. The company has put up 20 drugs for approval out of which it has got USFDA green signal for five. The process continues for the rest. Majority of the drugs relate to cardiac ailments. “The approvals were secured without a single observation from the USFDA, which is a major achievement for the company,” said a source. The Mihan unit has capacity to make 8 to 10 billion tablets of these five medicines. Lupin also had a plan to expand its units in Mihan by taking additional land in the SEZ. The project has, however, been put on hold. It had initiated negotiations with Maharashtra Airport Development Company (MADC) for the extra land. Sources said the plans have been put on hold at present. There are chances that the biotech project may be set up at Vizag, however, a final decision has not been taken on the project yet. ]]> <![CDATA[Generic Azilect tablets launched by Mylan]]> https://biospectrumindia.com/news/95/9004/generic-azilect-tablets-launched-by-mylan.html https://biospectrumindia.com/news/95/9004/generic-azilect-tablets-launched-by-mylan.html Mon, 05 Jun 2017 15:00:00 +0530 Mylan announced the U.S. launch of Rasagiline Tablets, 0.5 mg and 1 mg, a generic version of the reference listed drug, Teva's Azilect Tablets. Mylan received final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA) for this product, which is indicated in the treatment of Parkinson's disease. Rasagiline Tablets, 0.5 mg and 1 mg, had U.S. sales of approximately $343 million for the 12 months ending March 31, 2017. Currently, Mylan has 234 ANDAs pending FDA approval representing approximately $104 billion in annual brand sales. Mylan is a global pharmaceutical company committed to setting new standards in healthcare. The company offers a growing portfolio of approximately 7,500 marketed products around the world, including antiretroviral therapies on which approximately 50 per cent of people being treated for HIV/AIDS in the developing world depend. ]]> <![CDATA[Clinical trials for Bharat Biotech’s Chikungunya vaccine]]> https://biospectrumindia.com/news/95/8997/clinical-trials-for-bharat-biotechs-chikungunya-vaccine.html https://biospectrumindia.com/news/95/8997/clinical-trials-for-bharat-biotechs-chikungunya-vaccine.html Mon, 05 Jun 2017 12:25:00 +0530 Phase 1 human clinical trials of the indigenously developed Chikungunya (CHIKV) vaccine by Bharat Biotech is underway in India to evaluate the vaccine’s safety, tolerability and immunogenicity. The placebo controlled study involving 60 healthy volunteers would test escalating doses of the vaccine in prime-boost regimen.  The bone-breaking mosquito borne viral fever that caused the major 2006 epidemic possibly entered India from the Indian Ocean islands, and Bharat Biotech was the first Company to have isolated and characterised the epidemic strain. Bharat Biotech developed the CHIK vaccine using an isolate of the virus from Indian epidemic. The inactivated virus vaccine developed by the in-house R&D was found to be safe and immunogenic in pre-clinical animal testing. After successful completion of product development and pre-clinical testing, the candidate vaccine was approved by the DCG(I) for Phase 1 clinical trials in 2016.  Dr. Krishna Ella, Chairman & Managing Director of Bharat Biotech stated that Chikungunya is one among the modern day most dreaded virus, and developing an efficient vaccine to prevent it  means a lot to people at risk for the infection. The pre-clinical studies were promising and the company hopes that the first–in –human clinical trials successfully meets with the clinical endpoints. The candidate vaccine under development cross neutralized CHIKV isolates of the Asian genotype isolated in 1963 and isolates from the successive Indian epidemics caused by the East Central South African (ECSA) genotype since 2006. While CHIKV exists as three genotypes, there is only a single serotype of the virus. The candidate vaccine developed by Bharat Biotech effectively cross neutralized both the Asian and ECSA CHIKV genotypes.    Bharat Biotech filed a globally pioneering patent in 2007 for CHIKV drawing priority from 2006, and followed up with a second patent in 2011. Patents have been granted in USA, Europe, China, Indonesia, South Africa and is in National Phase in several other countries.  If phase 1 clinical testing is successful, Bharat Biotech plans to advance the vaccine into Phase II/III clinical development.  ]]> <![CDATA[Nutra Pharma announces collaboration with the University of Maryland Bioprocess Scale-up facility ]]> https://biospectrumindia.com/news/95/8992/nutra-pharma-announces-collaboration-with-the-university-of-maryland-bioprocess-scale-up-facility-.html https://biospectrumindia.com/news/95/8992/nutra-pharma-announces-collaboration-with-the-university-of-maryland-bioprocess-scale-up-facility-.html Fri, 02 Jun 2017 15:40:00 +0530 Nutra Pharma Corporation, a biotechnology company  specializing in the acquisition, licensing, and commercialization of pharmaceutical products and technologies for the management of neurological disorders, cancer, autoimmune, and infectious diseases, including Multiple Sclerosis (MS), Human Immunodeficiency Virus (HIV), Adrenomyeloneuropathy (AMN) and marketing Nyloxin and Pet Pain-Away in the over-the-counter (OTC) pain management market announced a collaboration with the University of Maryland Bioprocess Scale-Up Facility (BSF) to optimize manufacturing processes for the production of RPI-78M for the planned upcoming clinical trials in Pediatric Multiple Sclerosis. RPI-78M was originally derived from an extract of cobra venom and is an antagonist of the nicotinic acetylcholine receptor. The drug has a remarkably low toxicity with a very large therapeutic window. Scientific publications have demonstrated that native and modified neurotoxins can protect nerve cells from early cell death. Furthermore, it is expected that RPI-78M may be beneficial in neuromuscular disorders where the activity of nicotinic acetylcholine receptor has been compromised. The proprietary technology is covered by patents describing the application and use of RPI-78M in the treatment of autoimmune diseases. "Pediatric Multiple Sclerosis is a pressing and unmet medical need," stated Rik J Deitsch, Chief Executive Officer of Nutra Pharma. "These children have no therapeutic options that have been proven to be safe and effective for their disease. They must rely on off-label use of adult MS drugs," he continued. "We have been laying the groundwork to move into sanctioned trials ever since we received Orphan Designation for RPI-78M. Standardizing and scaling up drug production with BSF is the next logical step," he concluded. The company previously announced that they had been granted an Orphan Designation from the US-FDA (Food and Drug Administration) for the treatment of Pediatric Multiple Sclerosis with RPI-78M. The designation is designed to encourage the development of drugs which may provide significant benefit to patients suffering from rare diseases. "Based on our pre-clinical and open-label clinical studies, we believe that RPI-78M has the ability to successfully navigate the FDA approval process," commented Dale Vander Putten, PhD, Nutra Pharma's Chief Scientific Officer. "We believe that a recombinant product will ultimately provide these kids with the best possible drug. We are now working with the BSF to scale up drug manufacturing in preparation for the upcoming Phase II clinical trials," he concluded. The bioprocess scale-up facility will utilize the cloned alpha-cobratoxin gene as the raw material for the production of the recombinant drug, RPI-78M. BSF work will include process development and process optimization to develop an efficient, compliant and scalable process for the reliable production of high-quality material at a reasonable cost of goods.   ]]> <![CDATA[Metropolis Healthcare partners with IAP to conduct Academic Teaching Programme ]]> https://biospectrumindia.com/news/95/8980/metropolis-healthcare-partners-with-iap-to-conduct-academic-teaching-programme-.html https://biospectrumindia.com/news/95/8980/metropolis-healthcare-partners-with-iap-to-conduct-academic-teaching-programme-.html Thu, 01 Jun 2017 16:20:00 +0530 Metropolis Healthcare Ltd, global chain of pathology labs and diagnostic centers announces its partnership with the International Academy of Pathology – Indian Division (IAP-ID) for a mid-year teaching programme.  This two day programme will focus on standardising pathology reports of cancer specimen. Dr. Anita Suryanarayan, Vice President (South India & Sri Lanka), Metropolis Healthcare Ltd, said “Metropolis has always been at the forefront of such innovations and has focused on regulation and standardisation. We have invited faculty from leading International & National Centres to get a global and wider perspective.” Dr Kirti Chadha, Head of Department, Oncology, Metropolis Healthcare told, “A complete and accurate pathology report is crucial for getting a precise diagnosis and deciding on the best treatment plan for the cancer patient. With the help of CAP cancer protocols, the pathologists shall receive assistance that are clinically useful and have relevant information when reporting surgical specimen examinations.”   ]]> <![CDATA[Pfizer India to acquire AstraZeneca’s Neksium for Rs 750mn]]> https://biospectrumindia.com/news/95/8971/pfizer-india-to-acquire-astrazenecas-neksium-for-rs-750mn.html https://biospectrumindia.com/news/95/8971/pfizer-india-to-acquire-astrazenecas-neksium-for-rs-750mn.html Wed, 31 May 2017 16:45:00 +0530 Pfizer Limited (India) informed the stock exchange that it has entered into an agreement with AstraZeneca AB, Sweden, to acquire the brand “Neksium” in India for a value of INR 750mn. The transaction is subject to completion of requisite clearances.  Neksium was launched in India in the year 2006 and has developed strong equity with prescribers as a leading, high quality product in the Anti-Peptic Ulcerant space. Neksium, with the active ingredient Esomeprazole belongs to a class of pharmaceutical preparations called ‘Proton Pump Inhibitors’ (PPI) which are used effectively for reducing the acid secretion in the stomach. It is widely prescribed for the treatment of conditions across the Acid Peptic Disorders (APD) spectrum. “The Neksium acquisition is aligned with our stated ambition of portfolio expansion through organic and inorganic growth in our focus therapy areas. With this acquisition, we will accelerate our growth and strengthen our leadership position in the Gastrointestinal (GI) therapy area.” said Mr. S. Sridhar, Managing Director, Pfizer Ltd. With leading brands such as Gelusil & Mucaine, Pfizer Limited has been a trusted provider for strong and effective solutions in the Antacid space for over 30 years. The company is uniquely well placed to grow the Neksium brand further through its existing reach, coverage and equity in the GI therapy area. ]]> <![CDATA[Sun Pharma reports 9% growth in FY2017 at Rs. 30,264 crores]]> https://biospectrumindia.com/news/95/8955/sun-pharma-reports-9-growth-in-fy2017-at-rs-30264-crores.html https://biospectrumindia.com/news/95/8955/sun-pharma-reports-9-growth-in-fy2017-at-rs-30264-crores.html Tue, 30 May 2017 16:15:00 +0530 Sun Pharmaceutical Industries Ltd, India's top pharmaceutical company, reported a growth of 9% in sales / income from operations at Rs. 30,264 crores, over same period last year. The company reported a net profit for the FY17 at Rs. 6,964 crores, resulting Net profit margin of 23%. Net profit grew by 53% over the last year. Net profit for FY16 was adversely impacted by one-time items as well as exceptional charges of Rs. 685 crores.  Dilip Shanghvi, Managing Director, Sun Pharmaceutical Industries said, “For the full year FY17 sales in US were US$ 2,051 million, flat over last year. Sales for the year were boosted primarily due to the benefit of the 180-day exclusivity for Imatinib which commenced from 01-Feb-2016 and the authorized generic sales of Olmesartan and its combinations.”  For the FY17, sales of branded formulations in India were at Rs. 7,749 crores, higher by 8% over same period last year. For the full year FY17, sales were down by 8% at US$ 879 million. Net profit for FY17 was at US$ 456 million, a decline of 16% over same period last year. For the FY17, sales in emerging markets were US$ 675 million, up by 23% over same period last year. The growth is broad based amongst emerging markets. For the FY17, sales in Rest of World Markets (ROW) were US$ 385 million, up by 17% over same period last year. ROW markets accounted for approximately 9% of revenues for full year FY17. For the FY17, Active Pharmaceutical Ingredients (API) sales were up by 14% to Rs. 1,598 crores, partly driven by the consolidation of the Australian Opiates business. For FY17, R&D expenses were Rs. 2,314 crores or 7.6% of sales. This R&D expenditure includes investments on account of funding the clinical development of our global specialty pipeline. The company has a comprehensive product offering in the US market consisting of approved ANDAs for 427 products while filings for 157 ANDAs await US FDA approval, including 16 tentative approvals. ]]> <![CDATA[Sun Pharma reports 8% drop in Q4 gross sales at Rs. 6,825 crores]]> https://biospectrumindia.com/news/95/8954/sun-pharma-reports-8-drop-in-q4-gross-sales-at-rs-6825-crores.html https://biospectrumindia.com/news/95/8954/sun-pharma-reports-8-drop-in-q4-gross-sales-at-rs-6825-crores.html Tue, 30 May 2017 16:10:00 +0530 Sun Pharmaceutical Industries Ltd, the world's fourth largest specialty generic pharmaceutical company and India's top pharmaceutical company reported de-growth of 8% in sales/ income Income from operations at Rs. 6,825 crores for Q4 FY17 over the same quarter last year. Similarly the company has reported a Net profit at Rs. 1,223 crores, down 14% over Q4 last year, resulting Net profit margin of 18%. Dilip Shanghvi, Managing Director, Sun Pharmaceutical Industries said, “Our Q4 performance reflects the impact of the challenging generic pricing environment in the US. Despite this, we continue to invest our strong cash flows in enhancing our specialty pipeline. In Q4, we announced the acceptance of Tildrakizumab filing by EMA for European markets and for US market in May 2017. We will be gradually filing Tildrakizumab in all key markets in the next few quarters. We recently had a pre-NDA meeting with the US FDA for Seciera and we are on track to file this NDA by Q3FY18. We continue to evaluate filing Seciera in other markets. During the quarter, the US FDA lifted the import alert on the Mohali facility while remediation efforts are on-going to bring back the Halol facility into full cGMP compliance.” Sale of branded formulations in India for Q4FY17 was Rs. 1,916 crores, up 10% and accounting for 28% of total sales. For Q4FY17, the company launched 11 new products in the Indian market. Sales in the US were US$ 381 million for the quarter, a de-growth of 34% over same period last year and accounted for 37% of total sales. Sales for the previous quarter (i.e., Q4FY16) include the benefit of generic Imatinib exclusivity. At the same time, Taro posted Q4 FY17 sales of US$ 196 million, down 26% over Q4 last year. Taro’s net profit for Q4 was US$ 83 million, down by 28% over Q4 last year. Shanghvi noted that the sales in emerging markets were at US$ 181 million for Q4; a growth of 46% compared to the same quarter last year and accounted for 18% of total sales. This includes the contribution from JSC Biosintez acquisition in Russia. Formulation sales in Rest of World (ROW) markets excluding US and Emerging Markets were US$ 109 million in Q4FY17, a growth of 38% from the corresponding quarter last year, partly driven by consolidation of Japanese acquisition. ROW markets accounted for approximately 11% of revenues for Q4FY17. The company’s Active Pharmaceutical Ingredients (API) business imparts benefits of vertical integration for our formulations business. It continues to increase the API supply for captive consumption for key products. For Q4FY17, external sales of API were at Rs. 395 crores, up by 5% over Q4 last year. Consolidated R&D expense for Q4FY17 was Rs. 600 crores, or 8.8% of sales compared to Rs. 711 crores or 9.6% of sales for Q4 last year. For the quarter, 14 ANDAs were filed and 4 approvals were received. Additionally, the pipeline includes 36 approved NDAs while 5 NDAs await US FDA approval. ]]> <![CDATA[Sun Pharma announces US FDA filing acceptance of BLA for Tildrakizumab]]> https://biospectrumindia.com/news/95/8953/sun-pharma-announces-us-fda-filing-acceptance-of-bla-for-tildrakizumab.html https://biospectrumindia.com/news/95/8953/sun-pharma-announces-us-fda-filing-acceptance-of-bla-for-tildrakizumab.html Tue, 30 May 2017 16:05:00 +0530 Sun Pharmaceutical Industries announced the U.S. Food and Drug Administration (FDA) acceptance of the Biologics License Application (BLA) for tildrakizumab. The FDA filing acceptance follows the acceptance of the regulatory filing of tildrakizumab by the European Medicines Agency (EMA) in March 2017. Tildrakizumab is an investigational IL-23p19 inhibitor being evaluated for the treatment of moderate-to-severe plaque psoriasis. The BLA filing for tildrakizumab was submitted by Merck & Co., Inc., Kenilworth, NJ, USA. According to Abhay Gandhi, CEO - North America Business, Sun Pharma, “At Sun Dermatology, we are committed to making a difference in the lives of patients and healthcare providers. The acceptance of the regulatory filing by the U.S. FDA marks a significant milestone as we seek to advance for tildrakizumab as a potential new treatment option for people who continue to struggle everyday with the chronic nature of psoriasis.” The BLA filing for tildrakizumab with the U.S. FDA is based on two pivotal Phase III trials (reSURFACE 1 and 2) which included over 1,800 patients across more than 200 clinical trial sites, including some patients who have been treated with tildrakizumab for up to three and a half years. Data from these trials were most recently presented at the 2017 American Academy of Dermatology (AAD) Annual Meeting in March and previously presented at the 25th European Academy of Dermatology and Venereology Congress. Future presentations and publications of the reSURFACE Phase-3 pivotal trials will include more scientific insights on the data to week 52 and beyond. The clinical trials are designed to evaluate safety and efficacy for up to five years, and to date, some clinical trial participants have been treated with tildrakizumab for up to three and half years. ]]> <![CDATA[Lupin Pharma gets USFDA approval for five drugs]]> https://biospectrumindia.com/news/95/8942/lupin-pharma-gets-usfda-approval-for-five-drugs.html https://biospectrumindia.com/news/95/8942/lupin-pharma-gets-usfda-approval-for-five-drugs.html Mon, 29 May 2017 15:20:00 +0530 The company has secured United States Food and Drugs Administration (USFDA) approval for five of its drugs, which it plans to start exporting during the current financial year. These are generic drugs for cardiac ailments. Lupin already makes the branded version of these drugs for the domestic market. With approval of the generic medicines, Lupin is specifically targeting the US market. So far, the company was carrying out research and development work at the Mihan plant. Now, commercial production can begin as the approvals from USFDA have been secured. The company has put up 20 drugs for approval out of which it has got USFDA green signal for five. The process continues for the rest. Majority of the drugs relate to cardiac ailments. The 25 acre plant in Mihan has dedicated 15 acres for tablets and 9 acres for injectables. The injectables for cancer treatment are part of the company’s future plans. Under development at present, the injectables are expected to be put up for approval after two years. ]]> <![CDATA[Ozone Ayurvedics launches herbal eye drops]]> https://biospectrumindia.com/news/95/8940/ozone-ayurvedics-launches-herbal-eye-drops.html https://biospectrumindia.com/news/95/8940/ozone-ayurvedics-launches-herbal-eye-drops.html Mon, 29 May 2017 14:50:00 +0530 Ozone Ayurvedics, a company operating under the aegis of Ozone Group of Companies, has launched a herbal solution for dry eyes that is enriched with 11 organic herbal actives. ITIS Plus Care Eye Drops is designed to keep eyes well-lubricated, nourished, healthy and sparkling. This ophthalmic topical preparation is first-of-its-kind artificial tear drops. ITIS Plus Care Eye Drops is a sterile, isotonic Hydroxy Propyl Methyl Cellulose (HPMC) 0.3%, containing poly-herbal formulation to be used as therapeutic eye lubricant. It is designed to protect against eye strain and tear film loss by keeping eyes moist and nourished. A large number of Indians today suffer from eye issues such as fatigue, dryness, irritation, itchiness, infection, swollen eyelid, burning sensation and grittiness. This innovative eye drop offers a superior, efficacious and safe herbal solution to all the aforesaid problems as its basic formulation is clinically and scientifically proven by clinical trial (including 85 patients) conducted at Dr Rajendra Prasad Centre for Ophthalmic Sciences, All India Institute of Medical Sciences (AIIMS), New Delhi. ]]> <![CDATA[Fenway gets its first lab tenant]]> https://biospectrumindia.com/news/95/8924/fenway-gets-its-first-lab-tenant.html https://biospectrumindia.com/news/95/8924/fenway-gets-its-first-lab-tenant.html Fri, 26 May 2017 15:15:00 +0530 Fenway may be evolving into more than just a ballpark neighborhood, and just landed its first lab tenant. Decibel Therapeutics, a company focused on discovering and developing new medicines to protect, repair and restore hearing moved into its new headquarters and lab space in Samuels & Associates’ Van Ness mixed-use development at 1325 Boylston St., bringing 50 biotechnology jobs to Boston. The first biotech company to move into the area, Decibel joins a burgeoning health and technology hub, heralding a broader shift in The Fenway’s transformation. According to a news source, Decibel’s 32,000-square-foot facility in Van Ness features state-of-the-art laboratory space and work environments designed to foster collaboration across disciplines. The highly integrated environment will enable Decibel to scale its operations, build internal scientific capabilities and move programs into clinical development. Decibel was launched in October 2015 by Third Rock Ventures, a leading healthcare venture firm focused on disruptive areas of science and medicine to discover, launch and build companies that make a dramatic difference in people’s lives. “We’re very excited to be one of the first big idea biotech companies to move to The Fenway and bring innovative, meaningful businesses to the city of Boston,” said Kevin Starr, chairman of Decibel Therapeutics and partner at Third Rock Ventures. “Third Rock’s home has always been in Boston, and we see The Fenway as the next frontier to create an ecosystem of people and companies focused on groundbreaking science and making a difference for patients.” “Decibel’s headquarters and lab really mark a tipping point for health innovation companies falling in love with The Fenway,” said Peter Sougarides, principal, Samuels & Associates. “From PULSE@MassChallenge to Optum and now Decibel, companies of all sizes are drawn to our flexible spaces, proximity to the Longwood Medical Area and downtown, and amenities from parks to hot restaurants right outside the office.”Van Ness, which opened in summer 2015, consists of a residential tower and an office tower – built on spec and fully leased as of summer 2016 – both atop a 165,000-square-foot retail base with a variety of shops and restaurants.   ]]> <![CDATA[Jubilant increases prices for Vitamin B3 up to 15%]]> https://biospectrumindia.com/news/95/8920/jubilant-increases-prices-for-vitamin-b3-up-to-15.html https://biospectrumindia.com/news/95/8920/jubilant-increases-prices-for-vitamin-b3-up-to-15.html Thu, 25 May 2017 18:20:00 +0530 Jubilant Life Sciences Ltd, an integrated global Pharmaceutical and Life Sciences Company, has announced a price increase of up to 15% for its Vitamin B3 (Niacin & Niacinamide) with immediate effect, for non-contract customers and wherever existing contracts permit. This is further to the price increase of up to 15% announced in December 2016. Jubilant is the second largest producer of Vitamin B3 globally. The Vitamin B3 business is part of our Life Science Ingredients (LSI) segment, which offers a broad portfolio of high quality ingredients that find application in wide range of industries. The Pharmaceuticals segment, through its wholly owned subsidiary Jubilant Pharma Limited, is engaged in manufacture and supply of APIs, Solid Dosage Formulations, Radiopharmaceuticals, Allergy Therapy Products and Contract Manufacturing of Sterile and Non-sterile products through 6 USFDA approved manufacturing facilities in India, USA and Canada. The Life Science Ingredients segment, is engaged in Specialty Intermediates, Nutritional Products and Life Science Chemicals through 5 manufacturing facilities in India. The Drug Discovery Solutions segment, provides proprietary in-house innovation & collaborative research and partnership for out-licensing through 3 world class research centres in India and USA. Jubilant Life Sciences has a team of around 6,700 multicultural people across the globe and is committed to deliver value to its customers across over 100 countries. The company is well recognized as a ‘Partner of Choice’ by leading pharmaceuticals and life sciences companies globally. ]]> <![CDATA[Havas acquires health agency Sorento]]> https://biospectrumindia.com/news/95/8916/havas-acquires-health-agency-sorento.html https://biospectrumindia.com/news/95/8916/havas-acquires-health-agency-sorento.html Thu, 25 May 2017 16:50:00 +0530 Global communications agency Havas Group has acquired Indian healthcare advertising agency Sorento for an undisclosed sum. Sorento will partner with 'Havas Health and You' business unit and be rebranded Havas Life Sorento. Havas Health and You is the consumer healthcare division of the group. Currently, Sorento has clients including Abbott, Johnson & Johnson, Alkem, Dr Reddy's, Glenmark and Torrent, among others. The acquisition will allow Havas to further develop its regional presence as also to deliver quality for global clients. The co-founders and managing partners of Sorento, Susan Josi and Sangeeta Barde, will retain their roles and head the 70-person team. They will both report to Charles Houdoux, CEO, Havas Health & You Apac. ]]> <![CDATA[PCI Biotech and RXi Pharmaceuticals Extend Their Collaboration in the Field of Immuno-oncology]]> https://biospectrumindia.com/news/95/8912/pci-biotech-and-rxi-pharmaceuticals-extend-their-collaboration-in-the-field-of-immuno-oncology.html https://biospectrumindia.com/news/95/8912/pci-biotech-and-rxi-pharmaceuticals-extend-their-collaboration-in-the-field-of-immuno-oncology.html Thu, 25 May 2017 12:55:00 +0530 According to a press release, PCI biotech, a cancer focused Biopharmaceutical Company and RXi Pharmaceuticals, a biotechnology company focused on developing novel RNAi therapeutics for significant unmet needs announced that they are extending their preclinical collaboration initiated April 7, 2015. The preclinical research collaboration will evaluate technology compatibility and synergy based on in vivo studies. The companies will evaluate results achieved from this research collaboration and then explore the potential for a further partnership. Dr. Per Walday, CEO of PCI Biotech, said: "I'm very pleased to announce the extension of the existing research agreement. Our collaboration with RXi has been most fruitful and demonstrated a clear positive technological synergy that could realise significant value when applied to the emerging field of immuno-oncology. We look forward to exploring synergies between fimaNAc and RXi's innovative RNAi based compounds in the extended collaboration focusing on immuno-oncology opportunities." "Our collaboration with PCI Biotech over the last two years has been mutually very beneficial for our Companies," said Dr. Geert Cauwenbergh, President and CEO of RXi Pharmaceuticals. He added that, "We will learn how the PCI technology can even further enhance the time and the concentration our sd-rxRNA compounds can reside and be active in the immune cells. In the immuno-oncology space, where everybody talks about potency and safety of combinations, this continued and more focused collaboration could advance this therapeutic area significantly." ]]> <![CDATA[Bioverativ acquires True North Therapeutics]]> https://biospectrumindia.com/news/95/8910/bioverativ-acquires-true-north-therapeutics.html https://biospectrumindia.com/news/95/8910/bioverativ-acquires-true-north-therapeutics.html Thu, 25 May 2017 12:45:00 +0530 Bioverativ announced that it has entered into a definitive agreement to acquire South San Francisco-based True North Therapeutics, a privately-held, clinical-stage rare disease Biotechnology Company, for an upfront payment of $400 million plus assumed cash. According to the news in Business Wire, True North investors are also eligible to receive additional payments of up to $425 million contingent on the achievement of future development, regulatory and sales milestones. As part of the acquisition, Bioverativ will obtain worldwide rights to True North’s lead candidate, TNT009, a first-in-class monoclonal antibody in development to treat cold agglutinin disease (CAD). CAD is a rare and chronic hemolytic condition that often leads to severe anemia, requiring numerous transfusions, and can result in life-threatening thrombotic events. There are no approved therapies for CAD, which occurs in approximately 16 people per million globally, including an estimated 5,000 people in the United States. In May 2017, the U.S. Food and Drug Administration (FDA) granted TNT009 breakthrough therapy designation for the treatment of hemolysis in patients with primary CAD, and plans for the full clinical development program, including a registrational program, are underway. Breakthrough therapy designation was created by the FDA to expedite the development and review of medicines that target serious or life-threatening conditions and have shown preliminary evidence of potential clinical benefit. “One of our strategic priorities is to invest thoughtfully in business development with a focus on building our pipeline in areas where we believe we can make a real difference for patients,” said John Cox, Chief Executive Officer of Bioverativ. “This acquisition of True North is aligned with those goals and with our vision to become the leading rare disease company focused on blood disorders. It strengthens our pipeline with a potential first-in-class therapy to treat CAD, a rare blood disorder with a high unmet patient need.” “People living with CAD currently have no approved treatment options and suffer with a significant disease burden including crippling fatigue, frequent transfusions and an increased risk of life-threatening thrombotic events such as pulmonary embolism and stroke,” Mr. Cox continued. “By combining True North’s industry-leading science in complement biology with Bioverativ’s expertise in hematology and robust clinical and commercial capabilities, we believe we can bring meaningful progress to CAD patients. In addition, this transaction is consistent with our capital allocation philosophy, and we expect it to create significant value for our shareholders over the long term." “Today’s announcement and TNT009’s breakthrough therapy designation are testaments to the innovative science underpinning our lead candidate and the strength of the True North team. We are delighted to have progressed our pipeline to this stage,” said Nancy Stagliano, PhD, Chief Executive Officer of True North. “Bioverativ is well positioned to advance the development and commercialization of TNT009 on behalf of CAD patients who are greatly in need of safe and effective treatments.” The FDA granted TNT009 breakthrough therapy designation based on data from a Phase 1b trial, which showed that TNT009 normalized hemoglobin levels in six of six study participants with primary CAD, increasing hemoglobin by an average of 4g/dL and resolving their anemia. All participants were transfusion free while on treatment. TNT009 was generally well tolerated. As of December 21, 2016, five of six participants (83.3%) with primary CAD experienced at least one adverse event; all were mild to moderate in severity and no adverse event was assessed as related to TNT009 by the investigator. TNT009 is designed to selectively inhibit the classical complement pathway by targeting C1s and directly impacting the central mechanism of CAD. The only therapy in development that targets C1s, TNT009 has received orphan drug designation from the FDA and the European Medicines Agency. A number of other rare, complement-mediated diseases share the basic underlying pathological mechanism involving C1s that could potentially be addressed by TNT009. True North’s second molecule, TNT020, is a discovery-stage, follow-on monoclonal antibody that targets activated C1s with the potential for less-frequent dosing and subcutaneous administration. The acquisition will be financed through a combination of cash on hand and debt. It is subject to customary closing conditions, including the expiration of the applicable waiting period under the Hart-Scott-Rodino Antitrust Act of 1976 in the United States, and is expected to close in mid-2017. ]]> <![CDATA[Strides Shasun receives USFDA Approval for Memantine Hydrochloride Tablets]]> https://biospectrumindia.com/news/95/8896/strides-shasun-receives-usfda-approval-for-memantine-hydrochloride-tablets.html https://biospectrumindia.com/news/95/8896/strides-shasun-receives-usfda-approval-for-memantine-hydrochloride-tablets.html Wed, 24 May 2017 14:20:00 +0530 Strides Shasun Limited today announced that it has received approval from the United States Food & Drug Administration (USFDA) for Memantine Hydrochloride Tablets USP, 5 mg and 10 mg. According to IMS data, the US market for Memantine Hydrochloride Tablets USP, 5 mg and 10 mg is approximately USD 60 Million. The product will be manufactured at the Company’s flagship facility at Bangalore and marketed by Strides Pharma Inc in the US Market. The product will be launched immediately. Memantine Hydrochloride Tablets are indicated for the treatment of moderate to severe Alzheimer-type dementia. The Company has global manufacturing foot print with 8 manufacturing facilities spread across three continents including 6 US FDA approved facilities and 2 facilities for the emerging markets. The Company has three dedicated R&D facilities in India with global filing capabilities and a strong commercial footprint across 85 countries. ]]> <![CDATA[Cognizant introduces healthcare administration platform ]]> https://biospectrumindia.com/news/95/8884/cognizant-introduces-healthcare-administration-platform-.html https://biospectrumindia.com/news/95/8884/cognizant-introduces-healthcare-administration-platform-.html Tue, 23 May 2017 17:40:00 +0530 Cognizant announced the launch of the TriZetto Healthcare Cloud Solution, a new secure, compliant managed services platform for healthcare payers of any size, powered by Microsoft Azure.  The TriZetto Healthcare Cloud Solution provides a flexible, efficient on-demand infrastructure for increased operational efficiency, automation and reduced administrative costs. Based on Cognizant's TriZetto Facets and QNXT end-to-end core administration software, the new solution is available on Azure, Microsoft's HITRUST CSF-certified cloud platform. A managed services cloud solution enables healthcare organizations to pay only for the infrastructure they use, be more innovative and better respond to shifting regulations and reforms. The new TriZetto Healthcare Cloud Solution is being implemented by Wisconsin Physicians Service Insurance Corporation (WPS Health Solutions), a leading not-for-profit health insurer. Based in Madison, Wisconsin, WPS Health Solutions plans to migrate its administration infrastructure to the cloud to improve efficiencies and member experience and more rapidly introduce innovative new products across its plans. ]]> <![CDATA[DSM Sinochem Pharmaceuticals Wins Indian Patent Infringement Case Against Sinopharm Weiqida Pharmaceutical]]> https://biospectrumindia.com/news/95/8878/dsm-sinochem-pharmaceuticals-wins-indian-patent-infringement-case-against-sinopharm-weiqida-pharmaceutical.html https://biospectrumindia.com/news/95/8878/dsm-sinochem-pharmaceuticals-wins-indian-patent-infringement-case-against-sinopharm-weiqida-pharmaceutical.html Tue, 23 May 2017 11:40:00 +0530 DSM Sinochem Pharmaceuticals (DSP) which is the global leader in production and commercialization of sustainable, enzymatic antibiotics, next generation statins and anti-fungals recently announced that the High Court of Delhi has granted a permanent injunction against Sinopharm Weiqida Pharmaceutical for patent infringement in India. According to DSM Sinochem Pharmaceuticals’ (DSP) wholly owned subsidiaries, DSM Sinochem Pharmaceuticals Netherlands B.V. and DSM Pharmaceuticals India Pvt. Ltd., the High Court of Delhi, India, has granted a permanent injunction against Sinopharm Weiqida Pharmaceutical Co., LTD  ("Weiqida") for patent infringement of Indian Patent Number 247,301. This patent, which is owned by DSP, relates to amoxicillin trihydrate having a low free water content and processes for the manufacture thereof. The permanent injunction prevents the manufacture, use, importation, offering for sale and sale of Weiqida’s amoxicillin trihydrate active pharmaceutical ingredient in India, as well as any drug product that utilizes the active pharmaceutical ingredient. Karl Rotthier, CEO at DSP said,  “DSP welcomes the Court’s decision, The lawsuit is intended to protect DSP’s world class intellectual property portfolio relating to our innovative, sustainable, and environmental friendly amoxicillin technology.  DSP will continue to rigorously enforce its IP assets worldwide as it continues to invest in its innovative R&D programs directed to enzymatic, sustainable antimicrobials and statins.” ]]> <![CDATA[Baxter launches new hemodialysis system]]> https://biospectrumindia.com/news/95/8874/baxter-launches-new-hemodialysis-system.html https://biospectrumindia.com/news/95/8874/baxter-launches-new-hemodialysis-system.html Mon, 22 May 2017 17:40:00 +0530 Baxter International Inc. has launched a new version of its AK 98 hemodialysis (HD) system offering two-way IT connectivity, capabilities to meet the needs of patients with lower weights, and functions that simplify treatment set up and reduce downtime between sessions. The AK 98 system can be used to deliver HDx enabled by Theranova, Baxter’s latest hemodialysis therapy that provides high performance treatments with integration into existing healthcare infrastructure. Due to kidney failure, people with end-stage renal disease retain harmful toxins in their blood. During HD therapy, blood is passed through a dialyzer, which acts as the artificial kidney to filter toxins from the blood. The AK 98 system can now be connected to the dialysis provider’s central IT network, allowing seamless management and integration of clinic and treatment information. During treatment set-up, the hemodialysis prescription is sent to the AK 98 system from the provider’s central IT network. Once treatment is concluded, the encrypted data is transmitted back to the provider’s network, where it is secured and stored. Treatment data is then cleared from the AK 98 system. The AK 98 system, which first launched in 2015, is available in many countries in Asia, Europe and Latin America. It is not currently available for use in the United States. ]]> <![CDATA[Lupin gets approval for anti-allergy drug]]> https://biospectrumindia.com/news/95/8872/lupin-gets-approval-for-anti-allergy-drug.html https://biospectrumindia.com/news/95/8872/lupin-gets-approval-for-anti-allergy-drug.html Mon, 22 May 2017 16:30:00 +0530 Drug firm Lupin has received approval from the Central Drugs Standard Control Organisation (CDSCO) for Bepotastine tablets used in the treatment of patients suffering from allergic symptoms. Bepotastine is a new second generation antihistamine medicine to be introduced into the Indian Pharmaceutical Market (IPM), which could benefit millions of patients suffering from allergic symptoms. It is a rapid acting antihistamine that effectively controls day time and night time triggers of allergic symptoms. Bepotastine is approved by PMDA Japan and is actively marketed in Japan and other South-East Asian countries. The current market for plain antihistamines is estimated to be around Rs. 860 crore, growing at 14 per cent. ]]> <![CDATA[Aetna International launches ‘vHealth by Aetna’ an answer to all medical needs ]]> https://biospectrumindia.com/news/95/8856/aetna-international-launches-vhealth-by-aetna-an-answer-to-all-medical-needs-.html https://biospectrumindia.com/news/95/8856/aetna-international-launches-vhealth-by-aetna-an-answer-to-all-medical-needs-.html Fri, 19 May 2017 12:00:00 +0530 In a mega event at Le Meridien, New Delhi, Aetna International unleashed ‘vHealth by Aetna’, an app that provides a perfect remedy to all medical needs of the people. India became the launchpad for the ‘vHealth by Aetna’ and is also set to become the centre of excellence for global expansion of this service, with subsequent launches planned in other key global markets later this year. The Indian Health Organisation (IHO), Aetna International’s fully owned subsidiary in India, plans to have 4 million members in India by 2020, with revenue of INR 300 cr. ‘vHealth by Aetna’ is set to transform health care across the world.  The service is set to give patients a very different experience when they see a doctor, designed so that doctors have extended time with patients, to listen to their concerns, and treat them with courtesy and professionalism.  Consultations are delivered virtually, through a new mobile app, where they can communicate with in-house primary doctors by video call, or by telephone call.  The doctors can prescribe, refer to specialists, and advise on medical concerns.  Not only does this innovative service provide comprehensive, accessible primary health care, it also paves the way for a fully connected care package, reducing the need for hospital visits, and allowing members to manage their own health and keep all their health care records in one place. In order to subscribe for the service, a subscriber needs to purchase an annual subscription of Rs 2400 either by calling or logging on to IHO’s website. This subscription is valid for a family of four and if a person wants to include extra individuals then he can by paying extra charges. Dr Sneh Khemka, President of Population Health, Aetna International said, “At Aetna International, we believe that new innovations and technology will fundamentally change the way health care is managed and delivered. India has a reputation for rapid acceptance of technology, including smartphones, making it a perfect market for the launch of such an innovative tool, which we believe will revolutionize the primary care system.  The combination of our ‘vHealth by Aetna’ centre, our clinical expertise and our extensive network of medical partners, allows us to provide a uniquely integrated healthcare journey, which we believe will be of enormous benefit to our members.  We are very excited for India to be leading the way with this first launch of ‘vHealth by Aetna’.” Manasije Mishra, Managing Director, Indian Health Organisation & Aetna India said, “Health care can appear complex and hard to navigate. ‘vHealth by Aetna’ can be a guide and partner in managing your family’s health.”  He further added, “Our doctors are trained and certified as per Swiss tele-medicine standards, and follow robust clinical protocols built by Medgate A.G., a Swiss market leader in tele-medicine for over 15 years.  These protocols, customised for India, enable our doctors to provide evidence based diagnosis and care.  We believe that the resulting clinical quality, together with the breadth and convenience of this service will be unparalleled in the Indian health care market.” ]]> <![CDATA[Indian Health Organisation by Aetna International aims INR 300cr revenue from vHealth launch in India]]> https://biospectrumindia.com/news/95/8855/indian-health-organisation-by-aetna-international-aims-inr-300cr-revenue-from-vhealth-launch-in-india.html https://biospectrumindia.com/news/95/8855/indian-health-organisation-by-aetna-international-aims-inr-300cr-revenue-from-vhealth-launch-in-india.html Fri, 19 May 2017 11:55:00 +0530 Aetna International, one of the world’s largest health benefits businesses, has announced the first phase of the global launch of ‘vHealth by Aetna’. India is the first market in the world to see the launch of ‘vHealth by Aetna’ and is set to become the centre of excellence for global expansion of this service, with subsequent launches planned in other key global markets later this year. The Indian Health Organisation, Aetna International’s fully owned subsidiary in India, plans to have 4 million members in India by 2020, with revenue of INR 300 cr. ‘vHealth by Aetna’ is set to transform health care across the world.  The service is set to give patients a very different experience when they see a doctor, designed so that doctors have extended time with patients, to listen to their concerns, and treat them with courtesy and professionalism.  Consultations are delivered virtually, through a new mobile app, where they can communicate with in-house primary doctors by video call, or by telephone call.  The doctors can prescribe, refer to specialists, and advise on medical concerns.  Not only does this innovative service provide comprehensive, accessible primary health care, it also paves the way for a fully connected care package, reducing the need for hospital visits, and allowing members to manage their own health and keep all their health care records in one place. As well as the clear benefit of fast access to a doctor from any convenient location, ‘vHealth by Aetna’ is also very cost effective, reducing the need for a physical consultation by an average of 47%.  Patients can rate their doctors immediately, and each doctor is carefully audited to ensure only the highest care, whilst maintaining complete confidentiality. In India,’ vHealth by Aetna’ will be available at an annual subscription cost of Rs. 2400 for a family of four.  This will entitle members to unlimited primary care consultations, to include the management of chronic conditions, treatment of minor illnesses, advice on alternate treatment options, interpretation of diagnostic reports and guidance to stay healthy. Diagnostic tests can be arranged at the member’s home and medication can be delivered to their door. Doctors will also refer members to appropriate medical specialists at our partner centres at discounted prices where appropriate. Dr Sneh Khemka, President of Population Health, Aetna International said, “At Aetna International, we believe that new innovations and technology will fundamentally change the way health care is managed and delivered. India has a reputation for rapid acceptance of technology, including smartphones, making it a perfect market for the launch of such an innovative tool, which we believe will revolutionize the primary care system.  The combination of our ‘vHealth by Aetna’ centre, our clinical expertise and our extensive network of medical partners, allows us to provide a uniquely integrated healthcare journey, which we believe will be of enormous benefit to our members.  We are very excited for India to be leading the way with this first launch of ‘vHealth by Aetna’.” Manasije Mishra, Managing Director, Indian Health Organisation & Aetna India said, “Health care can appear complex and hard to navigate. ‘vHealth by Aetna’ can be a guide and partner in managing your family’s health.”  He continues, “Our doctors are trained and certified as per Swiss tele-medicine standards, and follow robust clinical protocols built by Medgate A.G., a Swiss market leader in tele-medicine for over 15 years.  These protocols, customised for India, enable our doctors to provide evidence based diagnosis and care.  We believe that the resulting clinical quality, together with the breadth and convenience of this service will be unparalleled in the Indian health care market.” ]]> <![CDATA[Mankind Pharma launches “Azilsartan” an Anti-Hypertensive drug ]]> https://biospectrumindia.com/news/95/8846/mankind-pharma-launches-azilsartan-an-anti-hypertensive-drug-.html https://biospectrumindia.com/news/95/8846/mankind-pharma-launches-azilsartan-an-anti-hypertensive-drug-.html Wed, 17 May 2017 11:20:00 +0530 With an aim of reducing hypertension, Mankind Pharma recently launched Anti-Hypertensive-drug Zolahart (Azilsartan), at an affordable price of Rs 7.50 per tablet. Research by the World Health Organization (WHO), shows that hypertension is one of the leading causes of premature deaths in India. It also exerts substantial public health burden on the cardiovascular health status of India. Azilsartan is a new generation Anti-hypertensive drug that offers potent and persistent 24 hours’ blood pressure control. It is proven to be safe for hypertensive patients with comorbid conditions like Diabetes or Chronic Kidney Disease (CKD). The recently launched Angiotensin-receptor-blocker (Azilsartan) is the most potent amongst ARBs and is expected to reduce the proportion of patients of uncontrolled BP considerably. Speaking on the development, Mr. R.C. Juneja, chairman and founder, Mankind Group said “At Mankind, we endeavour to bring the latest innovative therapies with assured quality that address primary healthcare challenge in India – world class quality at an affordable price. It is with this thought, we decided to launch Zolahart (Azilsartan), the latest Anti-Hypertensive Drug at the most affordable price of 7.50/Tab” which is 51% less than other competitors.   ]]> <![CDATA[Claris Lifesciences might exit Pharma biz]]> https://biospectrumindia.com/news/95/8845/claris-lifesciences-might-exit-pharma-biz.html https://biospectrumindia.com/news/95/8845/claris-lifesciences-might-exit-pharma-biz.html Tue, 16 May 2017 17:15:00 +0530 Ahmedabad-headquartered pharma player Claris Lifesciences, which recently divested its stake in a joint venture, Otsuka Pharmaceutical India Pvt Ltd (OPIPL), might be looking at exiting the pharmaceutical business altogether, Business Standard reported. Analysts point out that having sold its speciality injectables business to Baxter Inc last December, and now divesting its stake in the Otsuka JV, Claris would be looking at exiting the pharma business altogether. A Mumbai-based analyst said "This is a long-term strategic decision for the company. It now has a portion of its emerging markets business, which it might look at selling as well. The company would look at exiting the pharma business altogether and enter a new line of business as such." Arjun Handa, the executive vice chairman and group managing director of Claris Lifesciences Limited, is likely to exit the pharma business and start a completely new venture. On Monday, the company's Board approved the sale of its entire 20 per cent stake in the OPIPL to its partner Otsuka Pharmaceutical Factory Inc. for $20 million (approximately Rs 129 crore). Otsuka held 60 per cent in thr JV, while Mitsui held 20 per cent and the remaining 20 per cent was with Claris. The company's Board approved the sale of its entire 20 per cent stake in the OPIPL to its partner Otsuka Pharmaceutical Factory Inc. for USD 20 million (approximately Rs 129 crore). Otsuka held 60 per cent in thr JV, while Mitsui held 20 per cent and the remaining 20 per cent was with Claris. Earlier, in December 2012, Claris Lifesciences had entered into a joint venture with Japan's Otsuka Pharmaceutical Factory Inc and Mitsui & Co Ltd for its infusion business in India and emerging markets. The business was valued at Rs 1,313 crore at that time, and Claris had received total cash consideration of Rs 1,050 crore over multiple agreements. Claris had transfered the common solutions, anti-infectives, plasma volume expanders and parenteral nutrition therapies of Claris for India and the emerging markets to the Claris-Otsuka JV. Claris-Otsuka would co-brand its products in India and across emerging markets utilising the manufacturing and marketing backup of the Claris. Claris Otsuka Private Limited was rechristened as OPIPL on March 1, 2017. Last year December Claris had entered into a definitive agreement with US-based Baxter International Inc. to sell its wholly owned subsidiary Claris Injectables for approximately USD 625 million ( Rs 4,237 crore). The company is now working to close the deal. Sources indicated that a closure could be achieved around August-September this year. As such, earlier in April, India's Foreign Investment Promotion Board (FIPB) gave its nod to Claris Lifescience's injectables business sale to Baxter. The companies are now awaiting approval of the US competition watchdog, Federal Trade Commission. The Mumbai-based analyst added that Claris had indicated at the time of the Baxter deal that it intends to share a significant majority of the net cash proceeds from the sale with shareholders. A Nirmal Bang analysis had pointed out at that time, "The company may distribute cash either as dividend or by way of share buyback. In our view, a buyback is a more tax-efficient way. Assuming a 20 per cent discount to the value of the cash holdings with CLL, the buyback can be executed at a price as high as Rs 480 per share."   ]]> <![CDATA[Dr Reddy's signs agreement with US-based Amgen to market three drugs in India]]> https://biospectrumindia.com/news/95/8842/dr-reddys-signs-agreement-with-us-based-amgen-to-market-three-drugs-in-india.html https://biospectrumindia.com/news/95/8842/dr-reddys-signs-agreement-with-us-based-amgen-to-market-three-drugs-in-india.html Tue, 16 May 2017 15:45:00 +0530 Dr Reddy's Laboratories (DRL) has expanded its strategic collaboration with US-based independent biotechnology firm Amgen to market and distribute in India three of latter's medicines, used in the therapy areas of oncology and osteoporosis. Under the terms of collaboration, DRL will commercialise Xgeva (denosumab), Vectibix (panitumumab) and Prolia (denosumab) in India, a company statement said. In 2015, DRL announced an initial strategic collaboration with Amgen to execute a full range of regulatory and commercial services to seek approval and launch Amgen's Kyprolis (carfilzomib), Blincyto (blinatumomab) and Repatha (evolocumab) in India. “It strengthens our constant endeavour to enhance patient's access to novel treatment options across therapy areas. These medicines provide unique treatment options to physicians to address unmet medical need in the area of oncology and osteoporosis,” said MV Ramana, DRL's Executive Vice President and Head of Emerging markets and India Business. Penny Wan, Amgen Vice President and General Manager, Japan Asia Pacific Region said, “We are happy to strengthen our relationship with Dr Reddy's. Amgen is committed to addressing unmet medical needs of patients in India, and we are pleased with the commitment Dr Reddy's has demonstrated toward making our medicines available in India as quickly as possible.” Xgeva is a Rank ligand (RANKL) inhibitor and is approved in India for the prevention of skeletal related events in patients with advanced malignancies involving bone. Vectibix (panitumumab) is a cancer medication that interferes with the growth and spread of cancer cells in the body. ]]> <![CDATA[Merck opens new M Lab Collaboration Center in Bangalore]]> https://biospectrumindia.com/news/95/8831/merck-opens-new-m-lab-collaboration-center-in-bangalore.html https://biospectrumindia.com/news/95/8831/merck-opens-new-m-lab-collaboration-center-in-bangalore.html Fri, 12 May 2017 15:10:00 +0530 Merck, a leading science and technology company, announced the expansion of its M Lab Collaboration Center in Bangalore, India. The facility will provide biopharmaceutical manufacturers with a shared, exploratory environment where they can closely collaborate with Merck scientists and engineers to solve their toughest challenges and accelerate development of new therapies. The expanded center, measuring 806 square meters (8500 sq ft), leverages Merck’s world-class technical and application expertise. It includes a simulated manufacturing environment and enables collaboration with Merck experts to evaluate processes and accelerates development and production of new therapies.In addition, education on best practices and new approaches to develop, optimize and scale-up processes and ways to simplify global technology transfer will be available to customers. "Bangalore is a hub for India’s rapidly growing biopharmaceutical manufacturing industry,” said Udit Batra, Member of the Merck Executive Board and CEO, Life Science. “With the expansion of our M Lab™Collaboration Center in Bangalore, we are providing customers with hands-on experience and customized support required to optimize their manufacturing processes to quickly bring much-needed therapies to patients.”  The new M Lab Collaboration Center in Bangalore is one of nine such centers around the world. Each center helps customers, government collaborators, academia, regulatory bodies and industry associations to increase their productivity, mitigate risk and improve processes with the help of an industry-leading team of Merck experts. Customers have access to sizing and simulation tools and methodologies, analytical and modelling support, training sessions and educational programs. ]]> <![CDATA[Sangamo Therapeutics teams up with Pfizer]]> https://biospectrumindia.com/news/95/8825/sangamo-therapeutics-teams-up-with-pfizer.html https://biospectrumindia.com/news/95/8825/sangamo-therapeutics-teams-up-with-pfizer.html Thu, 11 May 2017 16:15:00 +0530 Sangamo Therapeutics, Inc. and Pfizer Inc. announced an exclusive, global collaboration and license agreement for the development and commercialization of gene therapy programs for Hemophilia A, including SB-525, one of Sangamo's four lead product candidates, which Sangamo expects will enter the clinic this quarter. Under the terms of the collaboration agreement, Sangamo will receive a $70 million upfront payment from Pfizer. Sangamo will be responsible for conducting the SB-525 Phase 1/2 clinical study and certain manufacturing activities. Pfizer will be operationally and financially responsible for subsequent research, development, manufacturing and commercialization activities for SB-525 and additional products, if any. Sangamo is eligible to receive potential milestone payments of up to $475 million, including up to $300 million for the development and commercialization of SB-525 and up to $175 million for additional Hemophilia A gene therapy product candidates that may be developed under the collaboration. Sangamo will also receive tiered double-digit royalties on net sales. Additionally, Sangamo will be collaborating with Pfizer on manufacturing and technical operations utilizing viral delivery vectors. Gene therapy is a potentially transformational technology for patients, focused on highly specialized, one-time, treatments that address the root cause of diseases caused by genetic mutation. There have been no gene therapy products approved in the U.S. to date. There are approximately 16,000 patients in the U.S. and more than 150,000 worldwide with Hemophilia A. SB-525 is comprised of a rAAV vector carrying a Factor VIII gene construct driven by a proprietary, synthetic, liver-specific promoter. The U.S. Food and Drug Administration has cleared initiation of human clinical trials for SB-525, which also has been granted orphan drug designation. Sangamo is on track this quarter to start a Phase 1/2 clinical trial to evaluate safety and to measure blood levels of Factor VIII protein and other efficacy endpoints. ]]> <![CDATA[GNH India clears Kenyan Pharmacy and Poison board audit]]> https://biospectrumindia.com/news/95/8816/gnh-india-clears-kenyan-pharmacy-and-poison-board-audit.html https://biospectrumindia.com/news/95/8816/gnh-india-clears-kenyan-pharmacy-and-poison-board-audit.html Thu, 11 May 2017 11:50:00 +0530 GNH India, a leading pharmaceutical distributor has cleared the Kenyan Pharmacy and Poisons Board audit thereby clearing the path for it to export scheduled drugs to Kenya. It has become the first Indian company to clear such audit. The certification will help GNH India trade freely with Kenya. The company will export the first shipment of lifesaving drugs to Kenya shortly and is looking to establish long lasting business relations with the country. The country, which has been facing a dearth of many lifesaving drugs in recent times will be benefited by this development. GNH India, exports to more than 180 countries and has 135,000 product lines to choose from which makes this company one of the leading businesses in the $12.5 billion Indian pharmaceutical export industry. This recent development has extended their reach into Kenya which has added to the long list of countries they already export medicines to. The Pharmacy and Poisons Board is the Drug Regulatory Authority established under the Pharmacy and Poisons Act, Chapter 244 of the Laws of Kenya, and is responsible for regulating the Practice of Pharmacy and the Manufacture and Trade in drugs and poisons in Kenya. Commenting on this, Dr Piyush Gupta, Associate Director, GNH India said, “GNH India has always believed that everyone should have access to proper healthcare and medicines, and we strive to deliver the same to the people irrespective of the global boundaries" "We always adhere to appropriate practices and maintain quality standards while servicing our clients, and being certified by The Pharmacy and Poisons Board, Kenya authenticates the measures taken by us for the exports of medicines. It gives us tremendous pleasure to be the first Indian specialized wholesaler to clear the audit by any foreign body, and we look forward to many more opportunities.” GNH India was audited in compliance to Good Distribution Practices (GDP), the criteria of the audit are based on World Health Organization’s (WHO) Good Distribution Practices for Pharmaceutical products and European Union’s guidelines on GDP of medical products for human use.   ]]> <![CDATA[Asthma drug by AstraZeneca fails]]> https://biospectrumindia.com/news/95/8812/asthma-drug-by-astrazeneca-fails.html https://biospectrumindia.com/news/95/8812/asthma-drug-by-astrazeneca-fails.html Wed, 10 May 2017 16:45:00 +0530 An experimental biotech drug for severe asthma from AstraZeneca failed to meet its goal of significantly reducing attacks in a late-stage study, dealing a blow to an approach that had already run into problems at Roche. Asthma affects about 315 million people worldwide, with about 10 percent suffering from severe asthma. AstraZeneca would now await the results from a second Phase III of tralokinumab in the second half of the year to see if the drug might help a sub-group of patients. Tralokinumab had been viewed as a risky project after Roche reported disappointing results with its similar medicine lebrikizumab last year. Both drugs block a protein called interleukin-13. AstraZeneca also has another experimental drug for severe asthma called benralizumab that works in a different way and is currently awaiting regulatory approval. It will compete with other recently approved treatments such as GlaxoSmithKline's Nucala. ]]> <![CDATA[Generic blood cancer drug launched by Natco]]> https://biospectrumindia.com/news/95/8811/generic-blood-cancer-drug-launched-by-natco.html https://biospectrumindia.com/news/95/8811/generic-blood-cancer-drug-launched-by-natco.html Wed, 10 May 2017 16:40:00 +0530 Natco Pharma has launched a generic version of pomalidomide capsules, used in treatment of a type of blood cancer, in India. Pomalidomide is a thalidomide analogue indicated, in combination with dexamethasone, for patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor and have demonstrated disease progression on or within 60 days of completion of the last therapy. Multiple myeloma is a cancer formed by malignant plasma cells. Natco has launched pomalidomide capsules in strengths of 1 mg, 2 mg and 4 mg in India. Pomalidomide is sold by Celgene Inc., in the USA, under the brand name POMALYST. Natco Pharma will market generic pomalidomide capsules under its brand name Pomalid in India. Natco Pharma addresses opportunities across the oncology, CNS, gastrointestinal, migraine and anti-depressant segments, each of which is growing in size and scope. ]]> <![CDATA[Rajasthan Antibiotics Ltd to raise Rs. 50 Crore VC Funding]]> https://biospectrumindia.com/news/95/8810/rajasthan-antibiotics-ltd-to-raise-rs-50-crore-vc-funding.html https://biospectrumindia.com/news/95/8810/rajasthan-antibiotics-ltd-to-raise-rs-50-crore-vc-funding.html Wed, 10 May 2017 14:55:00 +0530 Rajasthan Antibiotics Limited (RAL), which is a leading pharmaceutical company in North India is planning to raise an amount of Rs. 50 crores through venture capital (VC) funding by August-September 2017. BIORx Venture Advisors Pvt Limited (BIORx) has been mandated to syndicate funds. The funding would be pumped into company expansion through Greenfield and Brownfield. BIORx works as a financial and strategic partner for the life-sciences industry. In the past 25 years, RAL has grown both in size and reputation to become the nation’s largest producer of injectable antibiotics. The company has a diversified product mix that largely caters to two therapeutic segments, namely, Anti-Infective and gastroenterology. Mr. Ashish Pruthi, MD, RAL, said, “Our next target is to generate a revenue of INR 500 crores by 2020 and strengthening our position in the ever-growing niche segment of Steriles.”     ]]> <![CDATA[Torrent completes acquisition of Novartis brands]]> https://biospectrumindia.com/news/95/8790/torrent-completes-acquisition-of-novartis-brands.html https://biospectrumindia.com/news/95/8790/torrent-completes-acquisition-of-novartis-brands.html Tue, 09 May 2017 10:50:00 +0530 Torrent Pharmaceuticals completed the acquisition of Regestrone and Pregachieve brands in India from Swiss drug major Novartis AG. The flagship company of the Ahmedabad-based Rs 18,300 crore Torrent group had been in talks with Novartis to acquire to buy certain generic drugs from Swiss pharma major for quite some time. The two brands widely prescribed by gynaecologists for the management of abnormal uterine bleeding, post- menopausal symptoms and infertility will now be under the Torrent portfolio. Women's healthcare is an important therapy area for Torrent, which it intends to focus in the future. Regestrone and Pregachieve will further fortify the hormone segment. The use of hormones amongst the gynaecologists is on an increase because of lifestyle changes. Last month, Torrent had announced inking of pacts with Novartis AG to acquire the two brands. It, however, did not disclose financial details. Torrent Pharma has annual revenues of more than Rs 6,600 crore. ]]> <![CDATA[Bruker acquires microscopy company Luxendo]]> https://biospectrumindia.com/news/95/8786/bruker-acquires-microscopy-company-luxendo.html https://biospectrumindia.com/news/95/8786/bruker-acquires-microscopy-company-luxendo.html Mon, 08 May 2017 17:45:00 +0530 Bruker has acquired Luxendo, a privately held spin-off of the European Molecular Biology Laboratory (EMBL) that develops and manufactures proprietary light-sheet fluorescence microscopy instruments. Luxendo's proprietary single plane illumination microscopy (SPIM) technique significantly reduces sampling times over conventional laser scanning confocal microscopes, while reducing phototoxicity and damaging side effects on living specimens. This SPIM technology also enables the fastest scan speeds for volumetric imaging of small organisms, cell monolayers, and cleared tissue. Headquartered in Heidelberg, Germany, Luxendo was founded in September 2015. Under the technical leadership of Dr. Lars Hufnagel, Group Leader of the EMBL Cell Biology and Biophysics Unit, Luxendo was able to rapidly develop robust product solutions based on the patented SPIM technology. The SPIM microscopes significantly enhance Bruker's existing portfolio of swept-field confocal, super-resolution, and multiphoton fluorescence microscope product lines, enabling new research advances in small organism embryology, live-cell imaging, brain development and cleared brain tissue, and optogenetics applications. This acquisition is another important step forward in Bruker's portfolio transformation. ]]> <![CDATA[Natco Pharma launches generic hepatitis C drug in India]]> https://biospectrumindia.com/news/95/8783/natco-pharma-launches-generic-hepatitis-c-drug-in-india.html https://biospectrumindia.com/news/95/8783/natco-pharma-launches-generic-hepatitis-c-drug-in-india.html Mon, 08 May 2017 17:20:00 +0530 Natco Pharma has launched a generic version of sofosbuvir 400 mg/velpatasvir 100 mg tablets, used for treatment of chronic hepatitis C, in India under the brand name Velpanat. The company's product is generic version of Gilead Sciences Inc's Epclusa tablets. Epclusa is used to treat adults with chronic hepatitis C genotype 1 to 6 with or without cirrhosis. Natco priced its generic tablets at an MRP of Rs 18,500 for a bottle of 28 tablets in India. The company has signed a non-exclusive licensing agreement with Gilead Sciences Inc to manufacture and sell generic versions of its chronic hepatitis C medicines in 101 developing countries. Natco Pharma Limited was incorporated in Hyderabad in the year 1981 with an initial investment of INR 3.3 million. Natco today has five manufacturing facilities spread across India with dedicated modern research laboratories, capabilities in New Drug Development, etc. ]]> <![CDATA[PerkinElmer wins leadership award for contribution to Healthcare in India]]> https://biospectrumindia.com/news/95/8775/perkinelmer-wins-leadership-award-for-contribution-to-healthcare-in-india.html https://biospectrumindia.com/news/95/8775/perkinelmer-wins-leadership-award-for-contribution-to-healthcare-in-india.html Mon, 08 May 2017 12:45:00 +0530 PerkinElmer, Inc.  announced that it has received the Leadership Award for Contribution to Healthcare at the recent Healthcare Summit held in Bengaluru, Karnataka. Jayashree Thacker, President, PerkinElmer India, accepted the award from Shri KR Ramesh Kumar, Honorable Minister of Health and Family Welfare, Government of Karnataka and Smt KK Shylaja Teacher, Honorable Minister of Health and Social Welfare, Government of Kerala. “We are very happy to receive this recognition; it motivates us to continue to innovate for our customers throughout India, with advanced solutions that help protect the environment, the safety of our food, and the health of mothers, newborn babies and their families,” said Jayashree Thacker. “We are committed to contributing to State Government initiatives and national policies in India, bringing technology advancement, innovation and quality in healthcare service delivery,” added Dr. Ruchi Sogarwal, Deputy General Manager, Public Affairs & Policy, South Asia for PerkinElmer. Other dignitaries present included Shri K Rajeshwara Rao, Joint Secretary, Ministry of Health & Family Welfare, Government of India; Dr. Rathan Kelkar, Mission director, Government of Karnataka; Rina Desai, Head of Biocon Foundation; TL Alamelu, Director and General Manager, New India Health Insurance; and senior personnel from UNDP, World Bank, Public Health Foundation of India, UNESCO, Karnataka Health Promotion Trust and various other private institutions and non-government organizations. The Summit was organized by the Department of Health and Family Welfare, Government of Karnataka and National Health Mission, Karnataka. The summit focused on four thematic areas: Best Practices in Healthcare Delivery; Leadership and Governance to Healthcare Delivery; Strengthening Co-ordination – Self Help Group Model for Health; and Information Communication Technology in Healthcare.   ]]> <![CDATA[Mandira Bedi launches PHL products in New Delhi]]> https://biospectrumindia.com/news/95/8766/mandira-bedi-launches-phl-products-in-new-delhi.html https://biospectrumindia.com/news/95/8766/mandira-bedi-launches-phl-products-in-new-delhi.html Fri, 05 May 2017 12:30:00 +0530 In a mega event organised at Four Points by Sheraton, television diva, Mandira Bedi launched Planet Herb Lifesciences (PHL) products in New Delhi at ‘The Herbal Science Summit 2017’. The event was attended by some of the stalwarts of the healthcare industry with eminent speakers, such as Dr. Tripti Tandon, Celebrity Dietician, Dr. Aru Handa, Senior Consultant, Medanta-Medcity and Dr. Dolly Marya, Senior Consultant Obstetrician and Gynaecologist, The Marya Clinic and Max SmartSuper Speciality Hospital, sharing their views on the traditional medicines. Speaking on the occasion, VK Dhawan, CEO, PHL said, “To reintroduce age old methods with modern technology was the idea with which Planet Herb was born. Company’s main focus is to utilize the best resources from its own state and develop them into medicines which would help relieve modern ailments through natural therapy and products.” “I am true believer of originality and purity. Our body loves an organic routine as it is stress free and uplifts not only our system, but also our spirits. The step that PHL has taken to empower the country with traditional medicines is commendable and we will see its positive results in the coming future,” said Mandira Bedi. ]]> <![CDATA[Jubilant Life to buy Triad Isotopes' radio-pharmacy business ]]> https://biospectrumindia.com/news/95/8763/jubilant-life-to-buy-triad-isotopes-radio-pharmacy-business-.html https://biospectrumindia.com/news/95/8763/jubilant-life-to-buy-triad-isotopes-radio-pharmacy-business-.html Fri, 05 May 2017 11:15:00 +0530 Jubilant Pharma Ltd (JPL) through one of its wholly owned subsidiaries, has signed an asset purchase agreement with Triad Isotopes Inc and its parent, Isotope Holdings Inc (Triad) to acquire substantially all of the assets which comprise the radio-pharmacy business of Triad. The acquisition will be funded through JPL's internal accruals and is likely to be earnings accretive in the first full year of operations.  Triad operates the second largest radio-pharmacy network in the US with more than 50 pharmacies, distributing nuclear medicine products to the largest National GPOs, regional health systems, stand-alone imaging centres, cardiologists and hospitals.   The acquisition is a strategic fit to Jubilant's niche nuclear medicine business and will provide Jubilant with direct access to hospital networks with ability to deliver more than 3 million patient doses annually through approximately 1,700 customers.  It will facilitate Jubilant forward integrate in the radio-pharmaceutical business, thereby helping it better directly serve healthcare providers and their patients with high quality radio-pharmaceutical products ]]> <![CDATA[Agilent Technologies receives multiple awards in China]]> https://biospectrumindia.com/news/95/8761/agilent-technologies-receives-multiple-awards-in-china.html https://biospectrumindia.com/news/95/8761/agilent-technologies-receives-multiple-awards-in-china.html Fri, 05 May 2017 10:10:00 +0530 Agilent Technologies Inc. received three awards at the Annual Conference of China Scientific Instruments (ACCSI) 2017 in Nanjing, China. Agilent received the following awards: Green Product of the Year, Most Popular Scientific Instrument, and Most Influential Foreign Manufacturer. This year’s ACCSI conference brought together leaders from diverse industries to discuss topics that ranged from bioscience to food safety and environmental monitoring. Agilent has attended ACCSI since 2008 and has received 28 awards to date. The innovative Agilent Intuvo 9000 Gas Chromatograph (GC) System was selected as the Green Product of the Year. Designed together with customers, for customers, this transformational gas chromatograph makes complex technology easy to use. Click-and-run connections eliminate ferrules, guard-chip technology extends column life, and the trim-free column reduces retention time shifts due to column trimming maintenance. “We are pleased to receive the Green Product of the Year Award from the 2017 ACCSI conference,” said Shanya Kane, Agilent global vice president and general manager of Gas Chromatography. “The basis for this award corroborates the customer feedback we are receiving from labs across the globe regarding Intuvo’s contributions to laboratory throughput, space, and power efficiencies, as well as the designed-in simplicity of the user interface and operation.” The Agilent 5977B GC/MS System won the award for Most Popular Scientific Instrument. This single quadrupole GC/MS system features a high-efficiency ion source, which maximizes the number of ions that are created and transferred out of the source body and into the quadrupole analyzer, resulting in10 times greater sensitivity and detection limits as low as 1.5 fg IDL. Additionally, for the second year in a row, Agilent was recognized at ACCSI as the Most Influential Foreign Manufacturer. “We have made significant investments to provide innovative new offerings to the China market. We are driven to further improve our customers’ experiences, so we are proud that our efforts are being recognized by external agencies,“ said Mike McMullen, Agilent president, and CEO. ]]> <![CDATA[Brinton Pharma raises $4 mn from Tata Capital’s healthcare fund]]> https://biospectrumindia.com/news/95/8759/brinton-pharma-raises-4-mn-from-tata-capitals-healthcare-fund.html https://biospectrumindia.com/news/95/8759/brinton-pharma-raises-4-mn-from-tata-capitals-healthcare-fund.html Thu, 04 May 2017 16:15:00 +0530 Pune-based drugmaker Brinton Pharmaceuticals Ltd has raised Rs 25.6 crore ($4 million) from Tata Capital Healthcare Fund, the healthcare-focused arm of private equity firm Tata Capital Ltd. The investment will help Brinton enter new areas such as pediatrics and gynecology. It will also help it expand its international operations to 32 countries compared with eight currently. Brinton, which was founded in 2013, offers clinical and cosmetic dermatology formulations in therapy areas such as anti-fungal, topical corticosteroids, anti-acne, skin care emollients and hair care. Within a year, it became one of the fastest growing companies in the dermatology segment in India. The company expects its revenues from the dermatology segment to cross Rs 300 crore by FY2020-21. Brinton has a field workforce of 400 in India. Its operations are also spread across French-speaking countries and West Africa besides Nepal, Sri Lanka and Bangladesh. ]]> <![CDATA[SeQuent's arm Alivira gets USFDA nod ]]> https://biospectrumindia.com/news/95/8754/sequents-arm-alivira-gets-usfda-nod-.html https://biospectrumindia.com/news/95/8754/sequents-arm-alivira-gets-usfda-nod-.html Wed, 03 May 2017 17:46:04 +0530 Drug firm SeQuent Scientific’s arm Alivira received approval from the US health regulator for its animal health API facility in Visakhapatnam in Andhra Pradesh. Alivira Animal Health Ltd is a wholly-owned subsidiary of SeQuent Scientific. It has six manufacturing facilities. It is a global pharmaceutical company, in the Animal Health segment, with an integrated platform in both APIs (active pharmaceutical products) and Formulations. Headquartered in Ireland, manufacturing APIs in India, formulations in Turkey and a worldwide market presence, Alivira is infusing new life into Animal Care. The facility at Visakhaptnam was inspected for the first time by the USFDA in November 2016 and has now received Establishment Inspection Report (EIR) from the regulator. The receipt of the EIR will enable Alivira's entry into USD 8 billion veterinary healthcare market in the US. While the company is already working with most of the leading animal health companies the world over, this approval will enable it to expand its reach and consolidate relationship with these enterprises. ]]> <![CDATA[AstraZeneca’s Imfinzi (Durvalumab) receives US FDA accelerated approval ]]> https://biospectrumindia.com/news/95/8739/astrazenecas-imfinzi-durvalumab-receives-us-fda-accelerated-approval-.html https://biospectrumindia.com/news/95/8739/astrazenecas-imfinzi-durvalumab-receives-us-fda-accelerated-approval-.html Tue, 02 May 2017 16:30:19 +0530 AstraZeneca and its global biologics research and development arm, MedImmune, announced that the US Food and Drug Administration (FDA) has granted accelerated approval to IMFINZI™ (durvalumab). IMFINZI is indicated for the treatment of patients with locally advanced or metastatic urothelial carcinoma (mUC) who have disease progression during or following platinum-containing chemotherapy, or whose disease has progressed within 12 months of receiving platinum-containing chemotherapy before (neoadjuvant) or after (adjuvant) surgery. IMFINZI is approved under the FDA’s accelerated approval pathway, based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. IMFINZI is also under investigation in the Phase III DANUBE trial as first-line treatment in urothelial carcinoma as monotherapy and in combination with tremelimumab. Clinical trials have demonstrated that patients with PD-L1 high-expressing tumors have a higher likelihood of response through blockade of the programmed cell death or PD-1/PD-L1 pathway. PD-L1 expression testing may be a useful tool to help guide physicians in their treatment decisions, but it is not required for use of IMFINZI. ]]> <![CDATA[Takeda announces FDA Accelerated Approval of ALUNBRIG™ (brigatinib)]]> https://biospectrumindia.com/news/95/8728/takeda-announces-fda-accelerated-approval-of-alunbrig-brigatinib.html https://biospectrumindia.com/news/95/8728/takeda-announces-fda-accelerated-approval-of-alunbrig-brigatinib.html Tue, 02 May 2017 12:24:35 +0530 Takeda Pharmaceutical Company Limited announced that ALUNBRIG™ (brigatinib) has received Accelerated Approval from the U.S. Food and Drug Administration (FDA) for the treatment of patients with anaplastic lymphoma kinase-positive (ALK+) metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib. This indication is approved under Accelerated Approval based on tumor response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. ALUNBRIG, which previously received Breakthrough Therapy Designation from the FDA, is a once-daily oral therapy that may be taken with or without food. In recent years, small molecule ALK inhibitors have revolutionized the treatment options for those with advanced ALK+ non-small cell lung cancer. Nevertheless, there is still a need for additional ALK inhibitors like brigatinib (ALUNBRIG), which have a manageable safety profile and may address mechanisms of clinical resistance to crizotinib, including progression in the central nervous system. The ALTA (ALK in Lung Cancer Trial of AP26113) trial showed that brigatinib (ALUNBRIG) was highly effective post-crizotinib with the majority of patients who received 180 mg once daily with a seven-day lead in at 90 mg once daily achieving an overall response and a median duration of response greater than one year. Importantly, the extent of activity among those with brain metastases was also notable. The rapid development of ALUNBRIG is a tribute to the dedication of many research scientists and clinicians who carefully designed and developed this new medicine to address unmet medical needs in the ALK+ NSCLC patient population. ]]> <![CDATA[Samsung GC70 digital radiography system receives FDA clearance]]> https://biospectrumindia.com/news/95/8722/samsung-gc70-digital-radiography-system-receives-fda-clearance.html https://biospectrumindia.com/news/95/8722/samsung-gc70-digital-radiography-system-receives-fda-clearance.html Fri, 28 Apr 2017 16:39:25 +0530 Samsung announced that the GC70 Digital Radiography (DR) system received FDA 510(k) clearance for the U.S. market, underscoring the company’s commitment to expanding its suite of radiography products. The GC70 is leading a new generation of digital radiography systems that will make x-rays safer and healthcare more efficient for both patients and care providers. With FDA clearance of the GC70 and the GM85, health systems have two powerful new options for inpatient and ambulatory settings that represent affordability with quality care. The GC70 creates high-quality images with cutting-edge digital enhancements such as the S-Vue imaging engine, which provides high resolution images through adaptive filtering. Lightweight wireless S-Detectors that receive the x-ray signals come in multiple sizes, making the GC70 adaptable for use with patients of different ages and body habitus. Furthermore, tailored configurations of the entire GC70’s component set enable healthcare providers to use the DR system across many different service lines including: dedicated chest rooms, outpatient clinics and orthopedic practices. Disparate medical facilities require various options in order to satisfy diverse clinical needs and physical environments. The GC70 provides those options for efficient system customization. ]]> <![CDATA[Glenmark initiates clinical investigation for respiratory drug]]> https://biospectrumindia.com/news/95/8708/glenmark-initiates-clinical-investigation-for-respiratory-drug.html https://biospectrumindia.com/news/95/8708/glenmark-initiates-clinical-investigation-for-respiratory-drug.html Fri, 28 Apr 2017 12:14:43 +0530 Global pharmaceutical major Glenmark Pharmaceuticals has received the US Food and Drug Administration (USFDA) approval for the company’s Investigational New Drug (IND) application to initiate a first-in-human study of GBR 310, a proposed biosimilar candidate for Xolair which is used to treat persistent asthma in patients 6 years of age or older. This marks the second IND activation in 2017 for the growing respiratory portfolio of Glenmark. GBR 310 is a recombinant DNA-derived humanised immunoglobulin G1 kappa monoclonal antibody. Its current proposed indication is for the treatment of allergic asthma and chronic idiopathic urticaria. The reference product for GBR 310 is omalizumab, available under the brand name Xolair. According to Intercontinental Marketing Statistics sales data for the 12-month period ending February 2017, annual sales of Xolair 150 mg injection was approximately $1.7 billion in the US. ]]> <![CDATA[Serum Institute of India acquires Czech Republic's Nanotherapeutics ]]> https://biospectrumindia.com/news/95/8691/serum-institute-of-india-acquires-czech-republics-nanotherapeutics-.html https://biospectrumindia.com/news/95/8691/serum-institute-of-india-acquires-czech-republics-nanotherapeutics-.html Thu, 27 Apr 2017 16:10:04 +0530 World's largest vaccine manufacturer Serum Institute of India (SII), has acquired Czech biopharma company Nanotherapeutics for an undisclosed amount. This acquisition will add to SII group injectable Polio capacity, increasing it by 4 times to a total of 200 million doses by 2019, making SII the largest injectable non oral Polio vaccine manufacturer in the world. Nanotherapeutics has manufacturing capabilities for biologic products that will provide the department of defence and US government with ability to rapidly respond to emerging disease threats and chemical, biologic, radiological and nuclear events. For SII this is the current acquisition after 2012 in Holland. SII, Pune is currently one of the largest manufacturers of MMR group of vaccines and Pentavalent group of vaccines in the world, present in 147 countries. SII company plans to add around 200 employees in the next 2-3 years in Czech Republic. ]]> <![CDATA[Becton Dickinson to acquire Bard for $24 Billion]]> https://biospectrumindia.com/news/95/8686/becton-dickinson-to-acquire-bard-for-24-billion.html https://biospectrumindia.com/news/95/8686/becton-dickinson-to-acquire-bard-for-24-billion.html Thu, 27 Apr 2017 15:52:35 +0530 BD will acquire Bard for USD 317.00 per Bard common share in cash and stock, for a total consideration of USD 24 billion. The agreement has been unanimously approved by the Boards of Directors of both companies. The combination will create a highly differentiated medical technology company uniquely positioned to improve both the process of care and the treatment of disease for patients and healthcare providers. The transaction will build on BD's leadership position in medication management and infection prevention with an expanded offering of solutions across the care continuum. Additionally, Bard's strong product portfolio and innovation pipeline will increase BD's opportunities in fast-growing clinical areas, and the combination will enhance growth opportunities for the combined company in non-U.S. markets. This financially compelling transaction will be immediately accretive and is expected to generate high-single digit accretion to adjusted earnings per share (EPS) in fiscal year 2019. The transaction is expected to improve BD's gross margins by approximately 300 basis points in fiscal year 2018, increase BD's earnings per share growth trajectory to the mid-teens, and generate strong cash flow. ]]> <![CDATA[Dr Reddy’s launches Vytorin generic in US market]]> https://biospectrumindia.com/news/95/8683/dr-reddys-launches-vytorin-generic-in-us-market.html https://biospectrumindia.com/news/95/8683/dr-reddys-launches-vytorin-generic-in-us-market.html Thu, 27 Apr 2017 15:37:19 +0530 Pharma major Dr Reddy’s Laboratories Ltd has launched Ezetimibe and Simvastatin tablets in the US market. The product is a therapeutic equivalent of generic version of Vytorin (Ezetimibe and Simvastatin) tablets, a registered trademark of MSD International GmbH. The drug is indicated along with a proper diet to help lower "bad" cholesterol and fats. Vytorin contains a combination of ezetimibe and simvastatin. Ezetimibe reduces the amount of cholesterol absorbed by the body. Simvastatin is in a group of drugs called HMG CoA reductase inhibitors, or "statins." The Vytorin brand had US sales of approximately $678 million for the 12 months ended in February 2017. ]]> <![CDATA[Heptares collaboration with AstraZeneca yields new insights to drug discovery]]> https://biospectrumindia.com/news/95/8680/heptares-collaboration-with-astrazeneca-yields-new-insights-to-drug-discovery.html https://biospectrumindia.com/news/95/8680/heptares-collaboration-with-astrazeneca-yields-new-insights-to-drug-discovery.html Thu, 27 Apr 2017 15:21:43 +0530 Heptares Therapeutics, the wholly-owned subsidiary of Sosei Group Corporation, described new insights for drug discovery from the first resolved high-resolution X-ray crystal structures of the Protease-Activated Receptor-2 (PAR2) in complex with antagonist molecules. The research reports on findings from PAR2 bound and inactivated by small molecule and antibody antagonists. PAR2 is a G protein-coupled receptor (GPCR) that is a well-validated target for multiple indications in pain, cancer and inflammatory diseases, but which has previously proved to be intractable to conventional drug discovery approaches. PAR2 is an unusual GPCR that is activated by cleavage with a protease enzyme such that the cleaved part of the receptor acts as its own ligand. Because of this unusual mechanism of activation, it has been extremely difficult to identify PAR2 antagonists for development as new medicines. The structures have provided Heptares and AstraZeneca with a unique understanding of the precise mechanisms of action of these antagonists, which bind at novel allosteric sites distant from the ligand-binding site. In turn, these structural insights are providing a basis for further development of the small molecule drug candidates for a range of therapeutic indications. Access to the Heptares StaR technology enabled the team at AstraZeneca to progress available small molecule actives on PAR2 to credible lead series, where they earlier struggled to develop their chemistry. ]]> <![CDATA[USFDA nod to Zydus for anti-cholestrol drug]]> https://biospectrumindia.com/news/95/8674/usfda-nod-to-zydus-for-anti-cholestrol-drug.html https://biospectrumindia.com/news/95/8674/usfda-nod-to-zydus-for-anti-cholestrol-drug.html Thu, 27 Apr 2017 13:43:03 +0530 Drug firm Zydus Cadila has received approval from the US health regulator to market an anti-cholesterol drug, Cholestyramine, in the American market.  The US is the world's largest drug market and approvals to sell generic medicines there provide companies opportunities to increase their revenue.  The drug Cholestyramine is indicated as an adjunctive therapy to the diet for the reduction of elevated serum cholesterol in patients with primary hypercholesterolemia (elevated low density lipoprotein [LDL] cholesterol) who do not respond adequately to diet. The product would be manufactured at the company's facility at Baddi in Himachal Pradesh. The group has now more than 110 approvals and has so far filled over 300 ANDAs since the commencement of the filling process in financial year 2003-2004.  ]]> <![CDATA[Bio-sensing contact lenses for monitoring diseases]]> https://biospectrumindia.com/news/95/93/bio-sensing-contact-lenses-for-monitoring-diseases.html https://biospectrumindia.com/news/95/93/bio-sensing-contact-lenses-for-monitoring-diseases.html Mon, 17 Apr 2017 17:05:00 +0530 Scientists have developed contact lenses embedded with transparent biosensors that could help monitor blood glucose levels and telltale signs of a host of other disease without invasive tests. Bio-sensing lenses are based on technology that led to the development of smartphones with more vivid displays. Researchers from Oregon State University in the US first developed an inexpensive method to make indium gallium zinc oxide (IGZO) electronics. They then used the approach to fabricate a biosensor containing a transparent sheet of IGZO field-effect transistors and glucose oxidase, an enzyme that breaks down glucose. When they added glucose to the mixture, the enzyme oxidised the blood sugar. As a result, the pH level in the mixture shifted and in turn, triggered changes in the electrical current flowing through the IGZO transistor. Researchers then created nanostructures within the IGZO biosensor that were able to detect glucose concentrations much lower than found in tears. In theory, more than 2,500 biosensors - each measuring a different bodily function - could be embedded in a one millimetre square patch of an IGZO contact lens. Once they are fully developed, the biosensors could transmit vital health information to smartphones and other Wi-Fi or Bluetooth-enabled devices. ]]> <![CDATA[USFDA approval for Alembic Pharma]]> https://biospectrumindia.com/news/95/8543/usfda-approval-for-alembic-pharma.html https://biospectrumindia.com/news/95/8543/usfda-approval-for-alembic-pharma.html Mon, 10 Apr 2017 11:21:39 +0530 The US Food and Drug Administration has given approval to Alembic Pharmaceuticals for generic Fluoxetine Hydrochloride tablets used for the treatment of depression and panic disorder. This drug is a generic version of Prozac tablets manufactured by Eli Lilly and Company. Alembic Pharmaceuticals Ltd. is an Indian multinational pharmaceutical company based in Gujarat. The company has a total of 53 abbreviated new drug application (ANDA) approval from the US health regulator. Fluoxetine Hydrochloride tablets are prescribed for treating major depressive disorders and obsessive compulsive disorder in adult and paediatric patients. Fluoxetine is a selective serotonin reuptake inhibitors (SSRI) antidepressant. It affects chemicals in the brain that may be unbalanced in people suffering from depression, panic, anxiety, or obsessive-compulsive symptoms. The drug is available in the strengths of 10 and 20 mg. Common side effects associated with this drug include headache, dizziness, diarrhea, and weakness. ]]> <![CDATA[EpiPen being recalled due to a defect]]> https://biospectrumindia.com/news/95/8542/epipen-being-recalled-due-to-a-defect.html https://biospectrumindia.com/news/95/8542/epipen-being-recalled-due-to-a-defect.html Mon, 27 Mar 2017 13:22:23 +0530 EpiPens are auto-injectors that deliver lifesaving doses of epinephrine to individuals suffering from severe allergic reactions. If a person is experiencing anaphylactic shock, a shot is administered through the thigh muscle for delivering epinephrine.EpiPens are manufactured by Meridian Medical Technologies which is a US-based subsidiary of Pfizer. Two cases have been reported where EpiPens actually did not work. It might be due to the presence of a defective part causing a failure in the activation of the injector.As a result, about 500 EpiPens have been recalled in Denmark, 2000 in Norway, and an unspecified number in Ireland and Finland. These devices, which are being recalled, were distributed in Australia, New Zealand, Japan, and a variety of European countries, but not in the United States. The reports suggest that in total around 80,000 EpiPens are being recalled across multiple countries as they might fail to work in an emergency. ]]> <![CDATA[A new diagnostic platform based on CRISPR]]> https://biospectrumindia.com/news/95/94/a-new-diagnostic-platform-based-on-crispr.html https://biospectrumindia.com/news/95/94/a-new-diagnostic-platform-based-on-crispr.html Mon, 17 Apr 2017 17:05:00 +0530 A team of scientists from the Broad Institute of MIT and Harvard, the McGovern Institute for Brain Research at MIT, the Institute for Medical Engineering & Science at MIT, and the Wyss Institute for Biologically Inspired Engineering at Harvard University has adapted a CRISPR protein that targets RNA (rather than DNA) as a rapid, inexpensive, highly sensitive diagnostic tool with the potential for a transformative effect on research and global public health. The scientists demonstrated that this new technique will have a full range of applications such as detecting the presence of Zika virus in patient blood or urine samples within hours, distinguishing genetic sequences of African and American strains of Zika virus, discriminating specific types of bacteria, such as E. coli, detecting antibiotic resistance genes, identifying cancerous mutations in simulated cell-free DNA fragments, and rapidly reading human genetic information, such as risk of heart disease, from a saliva sample. CRISPR (Clustered Regularly Interspaced Short Palindromic Repeats) are the hallmark of a bacterial defense system which forms the basis for the popular CRISPR-Cas9 genome editing technology. Since the tool can be designed for use as a paper-based test that does not require refrigeration, the researchers feel that it is well suited for fast deployment and widespread use inside and outside of traditional settings such as at a field hospital during an outbreak, or a rural clinic with limited access to advanced equipment. ]]> <![CDATA[Alert issued on bio-resorbable stents]]> https://biospectrumindia.com/news/95/95/alert-issued-on-bio-resorbable-stents.html https://biospectrumindia.com/news/95/95/alert-issued-on-bio-resorbable-stents.html Mon, 17 Apr 2017 17:30:00 +0530 Almost five years after the launch of the revolutionary bio-resorbable stents in India, Union health authorities have recently issued a medical alert cautioning patients and doctors and asking them to report any problems. The Central Drugs Standard Control Organization (CDSCO)'s note posted on its website cited "safety concerns" as the reason. It has been observed that there is an over-elevated rate of major adverse cardiac events, specifically, myocardial infarction and scaffold thrombosis.Myocardial infarction is another term for heart attacks. The trial had compared bio-resorbable stent with drug-eluting stents, which are the most widely used cardiac devices. A senior CDSCO official, though, clarified that this isn't a ban or restriction on use, it is merely a cautionary exercise. The bio-resorbable stents were considered a path-breaking invention by MNC Abbott as these dissolve around three years after implantation, leaving no foreign metal like the drug-eluting stents, which are tiny scaffolding-like devices to clear blockages in arteries.While 5.6 lakh drug-eluting stents were used in India in 2015, the bio-resorbable ones account for a mere fraction. Abbott officials acknowledged that bio-resorbable stents comprise 1 per cent of their overall stent portfolio in India. These stents were not only expensive at Rs 1.9 lakh a piece -until the capping exercise pegged them at almost Rs 30,000 -but doctors need special training to deploy these   ]]> <![CDATA[A cure for acne in the form of vaccine]]> https://biospectrumindia.com/news/95/96/a-cure-for-acne-in-the-form-of-vaccine.html https://biospectrumindia.com/news/95/96/a-cure-for-acne-in-the-form-of-vaccine.html Mon, 17 Apr 2017 17:30:00 +0530 A team of scientists at the University of California San Diego may have found a cure for acne, but in the form of a vaccine.Acne is one of the most common skin conditions that occurs when oil and dead skin cells clog up the pores. The team of researchers found an antibody to a toxic protein secreted by the acne causing bacteria (Propionibacterium acnes) on the skin. The protein is associated with the inflammation that leads to acne. Researchers have developed a vaccine that will block the acne-causing effects of the bacteria without harming the benefits of bacteria. Acne vulgaris is a disease most commonly associated with P. acnes infection. The antibiotics most frequently used to treat acne vulgaris are erythromycin, clindamycin, doxycycline and minocycline. So far the vaccine has been tested on skin biopsies from acne patients which have produced good results. The next steps will be clinical trials and will hopefully make the vaccine public within the next couple of years. ]]> <![CDATA[India and UK team up to drive scientific and cultural boundaries]]> https://biospectrumindia.com/news/95/8664/india-and-uk-team-up-to-drive-scientific-and-cultural-boundaries.html https://biospectrumindia.com/news/95/8664/india-and-uk-team-up-to-drive-scientific-and-cultural-boundaries.html Wed, 09 Nov 2016 16:59:46 +0530 A series of joint India-UK research initiatives worth more than £80 million were announced by Indian Union Minister of Science and Technology and Earth Sciences, Dr Harsh Vardhan and UK Science Minister, Jo Johnson. The investments were announced during the India-UK Tech Summit being held in New Delhi and attended by Indian and UK Prime Ministers Narendra Modi and Theresa May. The TECH Summit has brought together British science and technology experts and businesses to India to show the best of what the UK has to offer. Supported by The Newton-Bhabha Fund, Research Councils UK, and Indian funding partners, the joint research will address major global challenges including healthcare, energy and food security. Jo Johnson, UK Minister of State for Universities, Science, Research and Innovation said "The joint research programmes announced today show the depth and breadth of the relationship that exists between India and UK. They will increase our collective knowledge, improve the lives of ordinary citizens and help tackle some of the major infrastructure and environmental challenges that lie ahead. Research has to be international and collaborative in its focus because the problems we face do not recognise borders." Dr Harsh Vardhan, Minister for Science and Technology highlighted that Narendra Modi, Prime Minister, India had declared that 2016 would be the Indo-UK year. He stressed that the presence of two prime ministers in the inauguration of the Tech Summit spells out the resolve of the two countries to take their partnership to the greatest heights with science as a crucial tool to alleviate the sufferings of each and every individual. "Possibilities of collaborations are extraordinary and they need to grow rapidly to boost quality science education and research in the new and upcoming institutions of excellence. Quality would entail scaling up opportunities of young scientists in these institutions to interact with scientists from UK through workshops and seminars, international level training in diagnosis, analysis and interpretation and exposing scientists from UK to the diversity of challenges that India offers which can inspire basic science," Professor K VijayRaghavan, Secretary DBT pointed out at a panel discussion at the summit. Professor Philip Nelson, Chair, RCUK Executive Group and CEO, Engineering and Physical Sciences Research Council (EPSRC) commented "International research collaborations that draw on the talents of academics across the world, are vital for us to tackle the big global challenges. Cooperation improves understanding of different cultures and ways of working. The UK's Research Councils will use the calls and projects announced today to build a prosperous, cleaner and healthier future." ]]> <![CDATA[Mylan and Biocon announce U.S. FDA submission for proposed biosimilar Trastuzumab]]> https://biospectrumindia.com/news/95/8656/mylan-and-biocon-announce-u-s-fda-submission-for-proposed-biosimilar-trastuzumab.html https://biospectrumindia.com/news/95/8656/mylan-and-biocon-announce-u-s-fda-submission-for-proposed-biosimilar-trastuzumab.html Wed, 09 Nov 2016 10:09:59 +0530 Mylan N.V. and Biocon Ltd. announced submission of Mylan's biologics license application for MYL-1401O, a proposed biosimilar trastuzumab, to the U.S. Food and Drug Administration (FDA) through the 351(K) pathway. This product is a proposed biosimilar to branded trastuzumab, which is indicated to treat certain HER2-positive breast and gastric cancers. Mylan and Biocon believe that this has the potential to be the first submission of a proposed biosimilar trastuzumab in the U.S. The submitted BLA includes a comprehensive package of analytical similarity, nonclinical and clinical data. The clinical data consists of two pharmacokinetic studies and the HERITAGE confirmatory efficacy and safety trial. The results of the HERITAGE trial were presented at this year's American Society of Clinical Oncology (ASCO) Annual Meeting and the European Society for Medical Oncology (ESMO) Congress. Mylan President Rajiv Malik commented: "The FDA submission for biosimilar trastuzumab marks Mylan's first FDA biosimilar submission from our broad portfolio of biosimilar products in development and our product has the opportunity to be the first biosimilar trastuzumab approved in the U.S. This submission also is another demonstration of the strength of the Mylan/Biocon partnership and our shared commitment to increasing access to these critical medicines worldwide. Our trastuzumab biosimilar is already being sold in 11 developing markets, including India, and we look forward to bringing the product to market in the U.S. and Europe upon approval." Dr Arun Chandavarkar, CEO & Joint MD, Biocon, commented: "The submission of our proposed biosimilar trastuzumab with the U.S. FDA is an important milestone of Biocon and Mylan's joint global biosimilars program and demonstrates our commitment to provide access to high-quality and affordable biologics to patients across the globe. Cancer patients in India and emerging markets have benefited with our trastuzumab and this advancement in the U.S. will enable us to enhance access to this affordable therapy to larger patient pools." ]]> <![CDATA[Biocon and Mylan announce regulatory submission for insulin Glargine accepted for review by European Medicines Agency]]> https://biospectrumindia.com/news/95/8654/biocon-and-mylan-announce-regulatory-submission-for-insulin-glargine-accepted-for-review-by-european-medicines-agency.html https://biospectrumindia.com/news/95/8654/biocon-and-mylan-announce-regulatory-submission-for-insulin-glargine-accepted-for-review-by-european-medicines-agency.html Fri, 04 Nov 2016 11:58:13 +0530 Mylan N.V.and Biocon Ltd. announced that the European Medicines Agency (EMA) has accepted for review Mylan's Marketing Authorization Application (MAA) for insulin glargine, a long-acting insulin analog used to treat adults with type 2 diabetes and adults and pediatric patients (children 6 years and older) with type 1 diabetes for the control of high blood sugar. Mylan and Biocon, which have co-developed insulin glargine, look forward to offering another insulin treatment option for diabetic patients, who are often facing significant expense to manage their disease. This filing includes analytical, functional and pre-clinical data, as well as results from the pharmacokinetics (PK) and confirmatory efficacy/safety global clinical trial in Type 2 diabetes patients comparing Mylan's and Biocon's Insulin glargine with Lantus. The PK study demonstrated PK and PD bioequivalence of Mylan's and Biocon's insulin glargine relative to that of the reference drug Lantus. Mylan President Rajiv Malik commented: "The acceptance of our regulatory submission for insulin glargine in Europe is yet another example of the strong progress we continue to make across the exciting portfolio of complex products we have in development, and is another demonstration of the success of our partnership with Biocon. Fifteen percent of the world's pharmaceutical spend will be on diabetes medicines by 2020[1] and there is a significant unmet need around the world for more affordable versions of injectable insulin products. We look forward to helping serve this patient population, building on our existing strength in oral diabetic drugs, by bringing this product to the European market and other markets around the world upon approval." Dr Arun Chandavarkar, CEO & Joint MD, Biocon, commented: "The acceptance of the insulin glargine application for review by the EMA is another important milestone in Biocon's collaboration with Mylan. This is the third filing from our portfolio comprising biosimilar monoclonal antibodies, insulin analogs and other recombinant proteins to be accepted by EMA in 2016. Importantly, this is the first filing in a developed market that incorporates product validated at our state-of-the-art Malaysia facility and takes us a step closer to our mission of improving access to more affordable insulins globally." ]]> <![CDATA[Advanced Enzymes acquires majority stake in JC Biotech]]> https://biospectrumindia.com/news/95/8650/advanced-enzymes-acquires-majority-stake-in-jc-biotech.html https://biospectrumindia.com/news/95/8650/advanced-enzymes-acquires-majority-stake-in-jc-biotech.html Thu, 03 Nov 2016 16:34:03 +0530 Advanced Enzyme Technologies Ltd has entered into definitive agreements with API maker JC Biotech to acquire 70 per cent stake for a consideration of Rs. 50 crore. The proposed transaction was approved by the Advanced Enzymes board recently.C L. Rathi, Managing Director, Advanced Enzymes, said, "We expect this deal to immediately strengthen our market leadership in API serratiopeptidase, giving us significant competitive advantage as well as flexibility in production." "JC Biotech has the ability to handle solvent-based fermentation and recovery, which is highly complementary to our current production process,'' he added. Headquartered in Hyderabad, JC Biotech is the manufacturer of API serratiopeptidase, an anti-inflammatory enzyme, and has a R&D pipeline of biopharma molecules. It also has a fairly advanced technology for the manufacturing of algal DHA, an Omega 3 Fatty Acid, which finds great application in human nutrition. JC Biotech has a production facility in Andhra Pradesh, and has the ability to expand its fermentation capacity further. JC Biotech currently commands a 50 per cent share in the Indian market, thereby taking Advanced Enzymes' combined market share to 80 per cent post acquisition.As of March 2016, JC Biotech's revenues stood at Rs. 39 crore with a profit after tax (PAT) of Rs. 2.5 crore. ]]> <![CDATA[Roche appoints new APAC head]]> https://biospectrumindia.com/news/95/8649/roche-appoints-new-apac-head.html https://biospectrumindia.com/news/95/8649/roche-appoints-new-apac-head.html Wed, 02 Nov 2016 13:49:00 +0530 Roche Pharmaceuticals Asia Pacific has appointed Dr Christiane Hamacher as Head of Asia Pacific (APAC). Christiane joined Roche in 2007 and was most recently General Manager of Roche Pharmaceuticals' Czech Republic business. In her new role, Dr. Hamacher will assume responsibility for the development and commercialisation of Roche Pharmaceuticals' innovative portfolio of medicines across APAC. Christiane will be based in Singapore and will lead more than 6,000 employees in 22 countries across the region. Commenting on her appointment, Dr. Christiane Hamacher said, "I am delighted to take up my new position as Head of APAC for Roche Pharmaceuticals Business. The region is of great importance to Roche and I am excited by the opportunities available to our business and our patients. Our success in Asia Pacific is founded upon our commitment to being one of the innovation-driven leaders in healthcare and I look forward to working closely with my colleagues to build on that success as we prepare for the launch of a number of innovative medicines throughout the region." ]]> <![CDATA[Strides Shasun receives FDA approval for Abacavir Tablets ]]> https://biospectrumindia.com/news/95/8646/strides-shasun-receives-fda-approval-for-abacavir-tablets-.html https://biospectrumindia.com/news/95/8646/strides-shasun-receives-fda-approval-for-abacavir-tablets-.html Wed, 02 Nov 2016 13:19:00 +0530 Strides Shasun Limited has announced that it has received approval from the United States Food & Drug Administration (USFDA) for Abacavir Tablets USP, 300 mg According to IMS data, the US market for Abacavir is approximately $30 Million. The product will be manufactured at the Company's USFDA approved facility at Bangalore and marketed by Strides in the US Market. The product will be launched immediately. Abacavir Tablets is indicated for the treatment of HIV-1 infection in combination with other antiretroviral agents ]]> <![CDATA[Tata Trusts, UC San Diego to establish TIAGS]]> https://biospectrumindia.com/news/95/8643/tata-trusts-uc-san-diego-to-establish-tiags.html https://biospectrumindia.com/news/95/8643/tata-trusts-uc-san-diego-to-establish-tiags.html Wed, 02 Nov 2016 13:18:53 +0530 Tata Trusts and the University of California San Diego has announced that they will together establish the Tata Institute for Active Genetics and Society (TIAGS) for collaborative partnership between the university and research in India. The goal of the Institute is to push the boundaries of bioscience in support of human needs and society, and to build scientific capacity in India. The Institute will specifically advance global science and technology research to ultimately find solutions to address some of the world's most pressing issues, ranging from healthcare to agriculture. The initiative's inaugural basic research enterprise-a thrust in Active Genetics-will be focused on applications of "active genetics" to improve human health and agriculture. Developed at UC San Diego, active genetics is a new field of genetics that incorporates a novel method, called "gene drive," for generating mutations in both copies of a gene in a single generation. Research efforts spearheaded by the Tata Institute for Active Genetics and Society will require and foster partnerships with scientific colleagues and government agencies in both India and the United States. A complimentary unit will also support a collaborative research enterprise in India (TIAGS-India). "UC San Diego's mission to advance society and drive economic impact aligns with our goals, as a country, to build a skilled scientific workforce and to grow the impact and scope of our research enterprise," said Ratan N Tata, Chairman, Tata Trusts. "Together, we will promote bioscience research, discoveries and education that will benefit populations around the globe." "As one of the of the world's top research institutions, we are committed to the global good," said UC San Diego Chancellor Pradeep K. Khosla. "This international collaboration to establish the Tata Institute for Active Genetics and Society will spark new scientific research and discoveries that will ultimately help us tackle some of the biggest challenges that face humankind in a socially conscious and ethical manner." University of California San Diego, which is ranked among the top 15 universities in the world, will create 10 endowed chairs, designed to attract and retain top scientists and faculty focused on research that aligns with the Institute's goals. In addition to a thrust in Active Genetics, the institute will also include a parallel thrust in Society and Ethics, and link Indian experts with larger research and education initiatives to effect societal progress. An important goal of the Center for Society will be to provide ethical guidance for the research activities of the Center for Active Genetics and the application of new technologies developed from the research in efforts to improve human health, agriculture and the environment. That will involve bringing researchers in India together with scholars from UC San Diego in the humanities and social sciences, such as Gender Equity and Health; as well as education, health, social protection, program evaluation, service delivery and environmental ethics. Leveraging cross-national, joint training opportunities to prepare future generations of scientific leaders in biotechnology and life sciences, the innovative binational structure of the Tata Institute for Active Genetics and Society will streamline transfer of active genetics technology to India. It will also serve to advance the biotechnology sector in India and establish a model for other global scientific endeavors. Viewing the collaboration with Tata Trusts as an honor for UC San Diego, Khosla said, "Growing up in India, I looked up to Tata family as champions of philanthropy for the human good. The Tata family's impact to bring about societal change and to build the country's infrastructure has been immeasurable. When Mr. Tata visited UC San Diego with researchers, he was immediately drawn to the impact of science and its strong linkages to bettering human society. It is a powerful partnership with unlimited potential to improve the world." Speaking on genetics, Ethan Bier, professor of biology at UC San Diego and pioneer in the field of active genetics, said, "Recent discoveries in genetics have created a new understanding of genes-not only just what they are or how they work, but also how they change or can be altered. This understanding, combined with novel technology of gene editing, has opened new areas for exploration that have potential applications in areas ranging from new health therapies, to prevention of the spread of disease, to agriculture uses." Dwelling on the role of the institute, he said, "One of the objectives of the Institute's research efforts will be to develop strains of mosquitoes that are unable to propagate malarial parasites." This effort could lead to the development of an effective way to combat vector-borne diseases, including malaria, a debilitating disease that afflicts hundreds of millions of people in tropical regions around the world. The collaboration also plan to apply active genetic technology to improve crops, enable new forms of cell therapy and develop ways to control microbial pathogens. The Institute will also host annual opportunities to meet and discuss ground-breaking genetics technologies, as well as to address safety, efficiency and ethics conversations around emerging fields of genetics. Annual symposia are planned in India to consider discoveries, opportunities and challenges for the future. ]]> <![CDATA[DBT unleashes its two initiatives to bridge farmers with biotechnology]]> https://biospectrumindia.com/news/95/8647/dbt-unleashes-its-two-initiatives-to-bridge-farmers-with-biotechnology.html https://biospectrumindia.com/news/95/8647/dbt-unleashes-its-two-initiatives-to-bridge-farmers-with-biotechnology.html Wed, 02 Nov 2016 13:18:31 +0530 In the recently concluded event at the CSIR Science Centre, New Delhi, Dr. Harsh Vardhan, Minister for Science and Technology and Earth Sciences, exchanged details of Department of Biotechnology's (DBT) two programmes, which are intended to have major impact on rural livelihood activities through biotech innovations. Dr Harsh Vardhan took the covers off from the project called 'Impacting People's Lives through Science'. Under this project, DBT will be closely working on two verticals, Biotech-KISAN and the Genomics of indigenous livestock. Shedding some light on one of the verticals, Biotech Kisan, Dr Harsh Vardhan said that the programme which focuses on small farmers will be a catalyst to make the existing systems reach out to the farmers more effectively and will also equip them with latest trend and technology. Adding further, he also laid heavy emphasis on latest communication technologies and revealed that the modern farmers are using latest communication methods such as 'Whatsapp' to gain access to the global information and to learn new techniques involved in farming and cultivation. Echoing the same voice, Professor VijayRaghavan, Secretary, DBT stated that the department has chalked down these initiatives in order to meet the modern farmer's desire for scientific approaches. Professor VijayRaghavan also highlighted the growing need for SNP genotyping and livestock improvement in India which could help protection and conservation of indigenous breeds of cattle, identification and mapping of temperature resistance, disease resistance, milk yield and QTLs for other economically important traits and also for genetic improvement of cattle. ]]> <![CDATA[Amitabh Bachchan opens the International Conference on Lung Health ]]> https://biospectrumindia.com/news/95/8642/amitabh-bachchan-opens-the-international-conference-on-lung-health-.html https://biospectrumindia.com/news/95/8642/amitabh-bachchan-opens-the-international-conference-on-lung-health-.html Thu, 27 Oct 2016 11:44:40 +0530 A message from Mr. Amitabh Bachchan, TB survivor and Ambassador, Call to Action for TB-Free India was one of the highlights of the inauguration of the 47th Union World Conference on Lung Health that began. Approximately 4000 delegates and participants from 130 countries attended the conference comprising a broad range of stakeholders committed to tuberculosis (TB) eliminationn: healthcare professionals, scientists, researchers, global advocates and community members involved in different aspects of lung health, specifically TB , and tobacco control. The theme for the conference is "Confronting Resistance: Fundamentals to Innovations". According to the World Health Organization, India is home to 2.8 million people with TB. In his video message, Mr Bachchan reiterated his support for the Indian Government's efforts to make India TB-Free and encouraged delegates to find solutions (new diagnostics, new drugs, shorter regimens, effective vaccines) that could put an end to the disease. Mr. Bachchan, spoke of how he was diagnosed with TB of the spine in the year 2000, at a time when he was hosting a popular Indian television show. He underwent rigorous treatment and was thankful for the exceptional support he received from his doctors and family that helped him recover and resume work. He was quick to point out that unfortunately, not all patients in India have access to the same quality of care that he received, and many with TB or multidrug resistant TB are not diagnosed early enough and/or drop out of treatment because of side effects or the long duration. He highlighted the fact that though TB disproportionately affects the poor , it is not only the poor who suffer from TB. as it is an airborne infectious disease. "Forgive my immodesty when I say this, but if it can happen to me, it can happen to you, to anyone," he said. In the video, Mr. Bachchan stressed the importance of ending the stigma and discrimination associated with the TB. He added, "Each of us has a role to play. We need our political leaders to commit at the highest level, in each of our countries, to provide the much-needed services to the most marginalised and vulnerable populations. We need to pool our resources to find effective solutions. And yes, we need much more investment in research. We need new diagnostics that make it easy to detect TB and new drugs that can shorten the course of treatment. And most importantly, we need an effective vaccine." In April 2015, the Government of India, Ministry of Health & Family Welfare launched the Call to Action For A TB-Free India to unite important stakeholders in collaborative efforts to put an end to the disease. OnOctober 27, 2016, The Union South-East Asia Office will hold a symposium at the conference on "Call to Action, tapping the energy and influence of key stakeholders towards a TB-Free India". The Symposium, which aims to foster partnerships with diverse sectors, will be chaired by Dr. Jagdish Prasad, Director General Health Services, from the Ministry of Health and Family Welfare, Government of India, along with speakers from Janssen ( J & J ) , Medanta and and The Union. "The Union is the leading scientific research organization working on Lung Health and is implementing large community and stakeholder engagement projects in India." Kavita Ayyagari, Project Director, Challenge TB, said, "With the WHO's new numbers of TB patients in India ( WHO Global TB Report 2016) , India needs to step up its efforts and engage with diverse stakehodlers to control the spread of TB. The Call to Action is a call to the private health sector, corporates, media and the civil society to come together." Jamie Tonsing, Regional Director, The Union South East Asia Office, said,,Globally, we need intensified actions and higher investments to end the TB epidemic. Over a quarter of all patients with TB are in India. Basic TB programmes must be effectively carried out, patients should receive treatment as soon as possible and there should be increased funding for TB research and development. Any and all resistance to the TB epidemic must be ended." ]]> <![CDATA[Dr. Reddy's inks pact with Gland Pharma]]> https://biospectrumindia.com/news/95/8644/dr-reddys-inks-pact-with-gland-pharma.html https://biospectrumindia.com/news/95/8644/dr-reddys-inks-pact-with-gland-pharma.html Thu, 27 Oct 2016 10:31:10 +0530 Dr. Reddy's Laboratories Ltd has entered into a strategic collaboration with Gland Pharma, a globally recognized developer and manufacturer of sterile dosage forms, to market and distribute a diverse portfolio of eight injectable Abbreviated New Drug Applications (ANDAs). The portfolio is a mix of filed ANDAs pending approval by the US Food and Drug Administration (USFDA) and ANDAs that will be filed imminently, and comprised of generic injectables administered in hospitals and clinics in the U.S. The combined sale of branded and generic versions of the products in the U.S. is approximately US$ 1 Billion MAT for the most recent twelve months ending in August 2016 according to IMS Health. Mr Alok Sonig, Executive Vice President and Head of North America said, "We are excited about this opportunity. Dr. Reddy's Laboratories has a strong track record in developing, marketing and distributing generic injectables in the U.S. Our strengths, combined with Gland's track record of manufacturing and operational excellence, will help bring affordable medications within reach of patients and complement our specialty injectables offering in the short-to-medium term." Srinivas Sadu, Chief Operating Officer of Gland Pharma added, "We are happy to expand our collaboration with Dr.Reddy's for marketing and distribution of Gland Products in US and other Ex US markets. Dr.Reddy's has an impressive track record of commercializing injectables products in the U.S, and we are confident that our partnership will continue to grow." Dr. Reddy's is aggressively developing its US injectable business and recently launched Paricalcitol Injection, a therapeutic equivalent generic version of Zemplar. ]]> <![CDATA[Takeda, Crescendo Biologics enter therapeutic collaboration]]> https://biospectrumindia.com/news/95/8640/takeda-crescendo-biologics-enter-therapeutic-collaboration.html https://biospectrumindia.com/news/95/8640/takeda-crescendo-biologics-enter-therapeutic-collaboration.html Wed, 26 Oct 2016 13:38:50 +0530 Crescendo Biologics Limited (Crescendo), the drug discovery and developer of Humabody-based therapeutics, and Takeda Pharmaceutical Company Limited announced a global, strategic, multi-target collaboration and license agreement for the discovery, development and commercialization of Humabody-based therapeutics for cancer indications with a high unmet medical need. Crescendo will use its proprietary transgenic platform and engineering expertise to discover and optimally configure Humabody candidates (Humabody Drug Conjugates and Immuno-Oncology modulators) against multiple targets selected by Takeda. "We see significant potential in Crescendo and its innovative technology to develop unique, small and customizable Humabody-based therapeutics," said Dr Andrew Plump, Chief Medical and Scientific Officer, Takeda. "Collaborations are critical to helping us achieve our aspiration of curing cancer. Working together with Crescendo will enable us to leverage its important technology to support Takeda's goal of developing next generation, highly modular and targeted therapies to treat cancer. "This collaboration with Takeda represents a significant step forward for Crescendo. It provides validation of our transgenic platform and our capabilities to rapidly assemble and configure small, differentiated Humabody-based therapeutics, opening routes to novel biology," said Dr. Peter Pack, CEO, Crescendo Biologics. "As a leading global pharmaceutical company, Takeda brings extraordinary expertise in the oncology area with significant capabilities in developing and delivering novel medicines to patients. This first major collaboration enables us to potentially broaden and accelerate innovative Humabody-based product candidates. " Under the terms of the agreement, Crescendo is eligible to receive up to $36 million, in a combination of an upfront payment, investment, research funding and preclinical milestones. Takeda will have the right to develop and commercialize Humabody®-based therapeutics resulting from the collaboration. Crescendo is also eligible to receive further clinical development, regulatory and sales-based milestone payments of up to $754 million. In addition, Crescendo will be eligible to receive royalties on Humabody-based product sales by Takeda. Takeda signed agreements with Crescendo Biologics through its wholly-owned subsidiary, Millennium Pharmaceuticals, Inc. ]]> <![CDATA[Everstone acquires majority stake in Rubicon Research ]]> https://biospectrumindia.com/news/95/8638/everstone-acquires-majority-stake-in-rubicon-research-.html https://biospectrumindia.com/news/95/8638/everstone-acquires-majority-stake-in-rubicon-research-.html Tue, 25 Oct 2016 10:38:05 +0530 The Everstone Group has bought a 70 percent stake in Mumbai-based Rubicon Research Pvt. Ltd., a pioneering drug delivery technology company in India, for a total outlay of Rs 220 crore ($33 million). Along with a $20 million investment directly into the business, the deal includes acquiring stakes from Kotak Private Equity and a private investor. Rubicon is an outsourcing partner to the global pharmaceutical industry and its proprietary technologies provide solutions for bioavailability enhancement, gastric retention, taste masking, and customising the release profiles of drugs. Rubicon also offers lifecycle management services for pharmaceutical products. Rubicon also has a USFDA approved manufacturing plant at Ambernath in Maharashtra, with a capacity of 800 million tablets and it has refocused its business on creating its own Abbreviated New Drug Applications (ANDAs)/New Drug Applications (NDAs) for the global market. "Rubicon has an excellent record of providing cutting-edge solutions to the healthcare and pharmaceutical industry," said Sameer Sain, Co-Founder and Managing Partner of the Everstone Group. "We are excited about enhancing its capabilities," Sameer added. Rubicon Founder and CEO Dr. Pratibha Pilgaonkar said: "We welcome this partnership with Everstone and believe, with their deep managerial and operational expertise, capital infusion, and global connectivity, we will be able to significantly accelerate our growth." This investment will be fourth investment from Everstone's latest PE fund (Everstone Capital Partners III) and was led by Deep Mishra, an Everstone MD who focuses on consumer and pharmaceutical investments for the Group. Deep will be joining the board of directors of Rubicon. ]]> <![CDATA[Sayre Therapeutics announces distribution agreement with Cancer Genetics Inc]]> https://biospectrumindia.com/news/95/8635/sayre-therapeutics-announces-distribution-agreement-with-cancer-genetics-inc.html https://biospectrumindia.com/news/95/8635/sayre-therapeutics-announces-distribution-agreement-with-cancer-genetics-inc.html Mon, 24 Oct 2016 16:32:17 +0530 Sayre Therapeutics, today announced an exclusive distribution agreement with Cancer Genetics Inc.(CGI), a leading organization for enabling precision medicine for oncology through molecular markers and diagnostics. This agreement is for the sales and marketing rights of the Cancer Genetics' Tissue of Origin (TOO) test in India and South Asia. The data that is generated by the use of the TOO test in India, would help in expanding CGI's base and thus validate its clinical utility, globally. Panna Sharma, CEO and President of Cancer Genetics, spoke about the partnership, "This partnership with Sayre Therapeutics, is a very important milestone for us, to make precision medicine available, in high-growth and high-demand markets such as India. We intend on continuing to widen the access to our exclusive branded selection of genomic and biomarker driven tests. Sayre has also established their spread and influence in the oncology sector throughout India." Dr Palanki Satya Dattatreya, Senior Consultant and Medical Oncologist, Omega Hospital, Hyderabad, said, "The condition of Cancer of Unknown Primary (CUP) is a common condition in India. It is an enigma to specialists and also, an aggressive disease with hostile diagnosis for patients. Mostly, patients with CUP are subjected to a number of tests and uncertainty about the disease and the condition. Using the TOO test can be extremely helpful, in such cases, as it is based on the concept of gene expression profiling. With its high specificity and sensitivity, the TOO test can remove ambiguity and also help the patient in gaining a more precise guideline-based therapy, which can result in potentially better survival rates." The TOO test is a microarray-based gene expression test which can locate or identify metastatic, poorly differentiated and undifferentiated cancers, among other challenging tumours. It can even help in reporting the tissue of origin of more than 15 common tumour types including thyroid, breast, non-small cell lung, pancreatic, gastric, colorectal, liver, bladder, kidney, non-Hodgkin's lymphoma, melanoma, ovarian, sarcoma, testicular germ cell and prostrate tumours. Using the TOO test can result in a change in treatment more than 65% of the time. Ravindranath Kunjithai, Head Medical and Regulatory Affairs, Sayre Therapeutics, said, "It is very optimistic to see that a large number of physicians have shown acceptance towards this test and agree that it can take things forward in the process of taking guided decisions or changes with regard to the treatment plan of patients with CUP." ]]> <![CDATA[Over 250 companies participated at analytica Anacon India and India Lab Expo 2016]]> https://biospectrumindia.com/news/95/8632/over-250-companies-participated-at-analytica-anacon-india-and-india-lab-expo-2016.html https://biospectrumindia.com/news/95/8632/over-250-companies-participated-at-analytica-anacon-india-and-india-lab-expo-2016.html Mon, 24 Oct 2016 12:07:27 +0530 analytica Anacon India and India Lab Expo, India's leading trade fairs for laboratory technology, analysis, biotechnology and diagnostics market, kicked of its 9th edition at the Hitex exhibition center in Hyderabad 20th October 2016. The twin trade fairs were inaugurated by Mr. Ashes Ganguly, President from Indian Analytical Instruments Association, Mr. P.V.Appaj, Director General from Pharmexcil, Mr. Venkateshwarlu, President from Telangana Chambers of Commerce and Industry and Mr. Ravindra Modi , President from Federation of Telangana and Andhra Pradesh Chambers of Commerce and Industry. It brought together internationally renowned exhibitors, consultants, business experts and key government officials on one common platform to discuss global best practices and seek solutions to some of the most pressing challenges related to the industry. The first day highlights of the trade fairs includes high-impact conference titled 'Science meets Technology' which focused on 'Regulatory aspects of Pharmaceutical Laboratories', 'Biopharmaceuticals and Bioanalysis', 'Food Safety' and 'Clinical Diagnosis'. The conference was hosted by the Indian Analytical Instruments Association (IAIA) and was attended by speakers, eminent scientists and industry representatives, coming from domestic and international markets. The program was rounded out by tutorials in four sessions where practical application tips were passed on the audience. There were more than 250 delegates participating at the conference who also had the opportunity to interact with eminent scientists visiting the twin trade fairs. The trade fairs also held pre-scheduled Buyer-Seller meetings simultaneously with the conference where more than 350 buyer-seller meetings have been scheduled over the span of three days out of which over 200 were VIP buyers. Exhibitors, decision makers and VIPs directly networked and interacted with clients and other industry delegates from international and domestic market and discussed about new equipments, technologies and solutions. The trade fairs witnessed around 250 exhibitors both from international and domestic market, who came together to provide solutions & promote best practices through technology. The exhibition saw participation from international pavilions like Germany and China and also witnessed exhibitors like asAbdos Labtech, Agilent Technologies, AJ Instrument, Akshaya Scientifics, Art Lab Equipments, Brand Scientific Equipment, Cryogen, Honeywell, IKA India, Merck Millipore, Newtronic Lifecare Equipment, Osworld Scientific Equipments, Shimadzu and Waters India showcase their products and services. For the first time ever, the trade fairs staged a Live Lab, where exhibitors and visitors had visual experience of lab demonstrations. A real life laboratory was set-up where exhibitors showcased and performed live experiments for the visitors by displaying and running instruments from their company. Visitors attended the Live Lab Demonstration included lab technicians, principal scientists and people related to research and development, quality control and contract research laboratories. analytica Anacon India and India Lab Expo received support from leading trade bodies and associations like the Indian Analytical Instruments Association (IAIA), Ambala Scientific Instruments Manufacturers Association (ASIMA), Bulk Drug Manufacturers' Association (BDMA), The Federation of Small & Medium Enterprises (FSME), The Federation of Telangana and Andhra Pradesh Chambers of Commerce and Industry (FTAPCCI), Indian Chemical Council (ICC), Indian Drug Manufacturer's Association (IDMA), Telangana Chambers of Commerce and Industry (TECCI), National Small Industries Corporation (NSIC), SPECTARIStrade association Analytical, Bio and Laboratory Technology from Germany and the Swiss-Indian Chamber of Commerce. Bhupinder Singh, CEO of Messe MÃ¼nchen India said "We are very happy to see a great response at analytica Anacon India and India Lab Expo 2016 in terms of visitors, exhibitors, delegates and key dignitaries both at the business meetings and at the technical forums. This is the first day of the trade fair saw an absolutely packed buyer-seller meet along with a much anticipated Live Lab Demonstrations which completely upped the ante in terms of a visitor and business experience at analytica Anacon India and India Lab Expo 2016." ]]> <![CDATA[OPPI releases IIM-A study on the state health index ]]> https://biospectrumindia.com/news/95/8636/oppi-releases-iim-a-study-on-the-state-health-index-.html https://biospectrumindia.com/news/95/8636/oppi-releases-iim-a-study-on-the-state-health-index-.html Mon, 24 Oct 2016 11:50:41 +0530 The Organisation of Pharmaceutical Producers of India (OPPI) concluded their golden jubilee celebrations. Mrs Meenakshi Lekhi (Member of Parliament and Supreme Court lawyer), Shri. Ravindra Chavan (Hon'ble Minister of State, Govt of Maharashtra), Shri. Sudhansh Pant (Joint Secretary, Department of Pharmaceuticals), Shri. A N Roy (Former Director General of Police, Maharashtra) were present on the occasion of celebrating the '50 Years theme: Healthy India, Innovative India. The event witnessed participation from Government, thought leaders in healthcare - technology companies, medical devices companies, diagnostic companies, healthcare providers, healthcare financers, media and other stakeholders. Highlighting his vision of a Healthy and Innovative India, Dr Shailesh Ayyangar, President, Organisation of Pharmaceutical Producers of India, Managing Director India and VP South Asia, Sanofi, said, "Over the years, the India story has witnessed significant milestones. Today, as a nation, we are at the edge of transformation. We have yet to fix healthcare financing issues, so that the disease burden doesn't impoverish our nation. More than ever, the need of the hour is for all stakeholders to come together to find solutions and keep our nation healthy. As OPPI completes its journey of 50 years, we are energized by the sheer opportunity of making a real difference to healthcare access in our country. We pledge our commitment to work with all stakeholders to achieve our collective dream of a Healthy and Innovative India." At the event, Shri. Ravindra Chavan, Hon'ble Minister of State, Government of Maharashtra, released a study on the 'Development of Health Index of Indian states' by the Indian Institute of Management- Ahmedabad (IIM-A), facilitated by OPPI. The results of the Study concluded that the states performed very differently on the two dimensions. The analysis showed low association between outcome and input variables. Maharashtra and Tamil Nadu were found amongst the best performers while Assam, Uttaranchal and Uttar Pradesh were lowest performers. States like Kerala, Himachal Pradesh, Delhi and J&K performed well. The states were then divided into three categories of high performers, middling performers and laggards for the purpose of policy directions. "This report is a first step. With the existing data, we are able to make limited comments on the drivers of changes - which can provide preliminary pointers on where action is required. At this stage, we are able to look at the changes in the underlying variables that may have caused the movement. Moving forward we will be able to provide more granular recommendations", said Prof. Arvind Sahay, IIM (A). OPPI's 50th Annual General Meeting marked an extraordinary moment with the release of its 50 years commemorative publication- 'The Colour of White'. Ms Meenakshi Lekhi along with Ms Radha Kapoor, Founder & Executive Director of ISDI, released this publication which showcased some of the key women achievers in the research-based pharmaceutical industry. Speaking on the occasion, Ms Kanchana TK, Director General, Organisation of Pharmaceutical Producers of India, said, "We believe that the handbook will be a small step in gender inclusion and we hope it will go a long way in motivating many young capable women to shape their careers in the pharmaceutical industry, making it their preferred choice. This is a first step of acknowledgment that the Gender Quotient Index (WILL Forum) in our industry is at a dismal 0.2 to 0.7. I am enthused with the fact that this is now on the dashboard of CEOs and as a collective effort we need to consciously include the better half of the gender populace." To mark the 50th AGM, an eminent panel of OPPI's Office Bearers decided to confer the OPPI Lifetime Achievement Award to Dr R A Mashelkar, National Research Professor & President, Global Research Alliance for his yeomen service in shaping the science and technology policies of the country. A Special Recognition Award for Innovation in Health was handed over to Manish Gupta, Co-Founder & Chief Executive Officer, Indegene, for delivering solutions that enable global healthcare organisations address complex challenges to improve patient outcomes. OPPI's Annual Excellence Awards were also announced. The winners are: OPPI Annual Excellence Awards for research and innovation in the industry were awarded to: â€¢ Scientist Award: Prof S. Ganesh, Department of Biological Sciences & Bioengineering, IIT Kanpurâ€¢ Young Scientist Award: Dr Rajnish Kumar Chaturvedi, CSIR-Indian Institute of Toxicology Research, Lucknowâ€¢ Woman Scientist Award: Dr Prathama Mainkar, CSIR-Indian Institute of Chemical Technology, Hyderabad The winners of the OPPI Excellence Awards in various categories were declared. Dr. H.R. Nanji Memorial OPPI Marketing Excellence Awards:â€¢ Existing Pharmaceutical Products: ULTRACET, Janssen Indiaâ€¢ New Pharmaceutical Products: DePURA, Sanofi India Ltd OPPI Best Vendor Awards:â€¢ Anti Counterfeiting Solution Provider: Schott Kaisha Pvt Ltdâ€¢ Packaging Material Supplier: ACG-Pharmapack OPPI Sales Force Excellence Award: â€¢ Sales Force Excellence Project: Shubh Labh, Sanofi India Ltd ]]> <![CDATA[Is public health in India secure?]]> https://biospectrumindia.com/interviews/95/8634/is-public-health-in-india-secure.html https://biospectrumindia.com/interviews/95/8634/is-public-health-in-india-secure.html Mon, 24 Oct 2016 11:50:19 +0530 The country's national capital is reeling under one of the worst outbreaks of dengue and chikungunya this year. The cases of chikungunya and dengue are soaring and health authorities are scrambling to contain the outbreak. According to a municipal report, at least 6,712 people have been afflicted with chikungunya in the national capital, with 1,473 cases of the vector-borne disease being reported in October. Though doctors have claimed chikungunya to be non-fatal, 20 patients suffering from this disease have reportedly died, and 25 people have died due to dengue. Health experts say the sudden "upsurge" of the disease this year could be a result of "evolution" of the viral strain. Speaking to BioSpectrum Asia Magazine, Dr Soumya Swaminathan, director general ICMR, elaborates on India's disease outbreak management strategy and the need for a national policy in disease/outbreak management. Q.India is reeling under one of the worst outbreaks of chikungunya and dengue this year. In your opinion what could be the reasons? A: India has been facing recurrent outbreaks of dengue almost every year. A major dengue outbreak was experienced last year as well (2015). In the current year, both dengue and chikungunya cases have been reported from many parts of the country. Intermittent rain with warm temperature and high humidity are the ideal conditions for mosquito breeding. Further, lot of construction activity and urban water storage provides breeding grounds for mosquitoes. Every year new cohorts of people, not previously exposed to dengue/chikungunya leads to an available pool of susceptible individuals with no pre-existing immunity. When such pool of people crosses a certain threshold, outbreak occurs. Chikungunya virus has only one serotype, whereas dengue has four different serotypes which do not cross protect against each other. In viewof this a person who has previously had dengue due to one serotype is susceptible to get infected by other serotypes and manifest as a full blown disease. However, after a major chikungunya outbreak, the population develops enough immunity, so we do not see another outbreak for 8-10 years. Q.What are the steps/measures taken by the government to attend to this crisis? A. Govt. has increased the availability of bed in various Govt. hospitals all across the country. Testing facilities have been increased significantly and the vector control measures have been intensified. The availability of platelets and blood products in various blood banks has been scaled up. IEC campaigns are being conducted through TV, radio, posters, newspaper etc., to create awareness among people towards the prevention and control of dengue. The situation is also being reviewed by high level Committees/Expert Groups, constituted by MoH&FW, on a regular basis. ICMR's NIV, Pune has devised cost-effective multiplex Dengue & Chikungunya RTPCR kits for early & accurate diagnosis of both the infections. The kits are currently under review and approval at ICMR/NIV. Currently, the IgM MAC ELISA kits being used by NVBDCP for confirmation of dengue and chikungunya are provided by NIV, Pune. Q.In your opinion what are the key measures needed, to curb this outbreak and prevent further spread? A: All the stakeholders like NVBDCP, Min. of Health, Municipal Corporations, Min. of Urban Development, Min. of Drinking water & Sanitation, ICMR, NCDC etc. need to come together and work in a coherent way to bring in effective vector control interventions. Data sharing among various Govt. and Private Hospitals is also essential. Since there is no effective drug or vaccine for dengue and chikungunya, these diseases can only be prevented by implementing effective vector control interventions. Since Aedes aegypti breeds mainly in households, community awareness is the key to reduction in breeding sources. In addition, suboptimal solid waste management leads to increase in sources of vector breeding in times of monsoon. Lack of piped water supply in many parts of the country, leads to people storing gallons of water in their houses. This in turn leads to vector breeding and spread of dengue and chikungunya. Vector control interventions need to be implemented by multiple stakeholders. Community awareness towards prevention of vector breeding needs to be intensified. Involvement of school children in a major way may help significantly. All these steps need to be taken before the beginning of high transmission season. Q.Dengue and chikungunya is a continuing problem in India. What is India's policy in preventing and controlling the spread of vectorborne diseases? A: The Govt. of India has established the Directorate of National Vector Borne Disease Control Programme (NVBDCP), which is the central nodal agency for prevention and control of vector borne diseases i.e. Malaria, Dengue, Lymphatic Filariasis, Kala-azar, Japanese Encephalitis and Chikungunya in India. The NVBDCP has formulated National guidelines for prevention and control of Dengue, Chikungunya, Lymphatic Filariasis etc. These guidelines are disseminated to all States through various workshops and trainings organised by NVBDCP. Dengue has also been made a notifiable disease in many parts of India, though this needs to be reinforced in a stricter way. Q.With scary viruses daunting the globe, an epidemic threat looms over India. Is India prepared to handle an epidemic outbreak? A: Yes, India has been prepared to handle viral epidemics occurring all over the globe. During the 2009 H1N1 Influenza pandemic, the Min. of Health as well as ICMR had put in place several measures to combat the disease, which was appreciated all across the world. An Influenza surveillance network comprising of 11 geographically well distributed sites was set up. These sites worked under supervision of NIV, Pune and generated data on prevalent Influenza strains and suggested Influenza vaccine composition that would be ideal for India. The network is still in place and has been expanded. In addition, indigenous Influenza vaccines (by Serum Institute and Lupin Labs) were given fast track approvals and marketing permissions. Indigenous rapid Influenza diagnostic kits were also developed. In 2014, when India was facing a threat of Ebola viral disease, the ICMR's NIV, Pune had trained 13ICMR/non-ICMR BSL III laboratories all across the country for the diagnosis of Ebola virus infections. All labs were given reagents, kits and personal protective suits after the training. The Min. of Health had linked all these labs to the nearest airports for testing samples of all Ebola suspect individuals detected at various airports. ICMR has also trained 10 labs for Zika virus testing, at NIV, Pune. All these labs have been provided reagents and primers and are regularly screening for Zika infection in dengue and Chikungunya negative patients. Entomological surveillance for Zika virus in Aedes mosquito has also been initiated by ICMR Institutes in some southern States as well as Delhi. Q. What is India's outbreak management strategy? A: The Govt. of India/DGHS has established the Integrated Disease Surveillance Project (IDSP), managed by NCDC. The mandate of IDSP is to conduct district wise surveillance of all bacterial and viral diseases which have a potential to cause outbreaks. The IDSP raises an alarm for the public health authorities to act, whenever there is clustering of cases/deaths in any particular areas. Besides, DHR/ICMR has set up a network of 45 Viral Research & Diagnostic Laboratories in almost all States of the country to test and diagnose viral infections prevailing in various States. All the labs have been linked with NIV, Pune for training and QA/QC purpose. The DHR has a target to set up 160 such labs in India.The VRDLs have capacity to test for almost 30 -35 viruses including the ones known to cause major outbreaks. Q.Is it time to have a national policy for drug development and epidemic outbreak? A: The WHO has recently (May 2016) laid down a blue print for epidemic prone diseases. This delineates strategies for rapid activation of research and development activities for better understanding of an epidemic-prone disease, development of life-saving drugs, vaccines and diagnostics for prevention of such epidemics. ICMR is planning to deliberate on this soon. Q. How does government encourage new drug research for new and rare organisms? A: Several Govt. agencies like ICMR, CSIR, DST, DBT fund research on new drug development. CSIR's Central Drug Research Institute specifically works on new drug development. Q. Is it time to have a collaborative approach and establish more PPP models to encourage research of rare viruses and bacteria to develop effective medical interventions? A: Yes, definitely Public Private Partnerships are welcome. The Govt. alone cannot do everything; the private companies can financially and logistically support many programmes as a CSR initiative. ICMR has recently signed MoU with Sun Pharma for Malaria free India. The Malaria free project is soon being launched by ICMR's National Institute for Research in Tribal Health (NIRTH) in Mandla district of Madhya Pradesh. ICMR is also engaging with SunPharma to strengthen capacity on clinical trials in ICMR Institutes. We look forward to such partnerships in future too. Q. Please outline some efforts taken by ICMR in reducing disease burden in the country and promoting well-being. A: ICMR has several contributions in strengthening the public health system of the country and reduction of burden of several diseases. The key contributions of ICMR are: The Enterovirus Research centre at Mumbai has served as a backbone to the Polio elimination programme inthe country. The Centre evaluated immunogenicity of monovalent, bi-valent and trivalent OPV for introduction of new polio vaccines for polio eradication. The various trails conducted at EVRC provided data to the programme for strategic introduction of various Polio vaccinesat different time points. In addition, The Centre is a pioneer in setting up sewage surveillance for Polio viruses in Mumbai. The programme has now been expanded to many States.The Rajendra Memorial Research Institute of Medical Sciences at Patna has contributed significantly in operational research providing effective tools for surveillance, diagnosis, treatment and vector control under national kala-azar elimination programme.National Institute of Virology at Pune has partnered with Bharat Biotech International ltd. to develop an indigenous vaccine for Japanese encephalitis. The vaccine is available in the market.The National Institute for Research on Tuberculosis has undertaken landmark research in several areas including the effectiveness of domiciliary treatment for TB,the need for supervising treatment, the efficacy of intermittent short-course chemotherapy regimens, and the protective efficacy of BCG vaccine. ]]> <![CDATA[Biocon Q2 FY17 revenue up 21%]]> https://biospectrumindia.com/news/95/8629/biocon-q2-fy17-revenue-up-21.html https://biospectrumindia.com/news/95/8629/biocon-q2-fy17-revenue-up-21.html Fri, 21 Oct 2016 10:33:34 +0530 Biocon has announced its consolidated financial results for the second quarter ended on September 30th, 2016. The Biopharma firm reported a robust performance with a revenue growth of 21% at Rs 992 Cr led by a strong growth of Small Molecules, Biologics and Syngene. Licensing Income this quarter stood at Rs 32 Cr while Other Income reported was Rs 52 Cr. EBITDA rose 45% to Rs 277 Cr; Net Profit stood at Rs 147 Cr a growth of 52% over last year (after excluding impact of exceptional items due to INDAS adjustment to Q2FY16 numbers) Net R&D spends during the quarter stood at Rs. 65 Cr, an increase of 14% YOY. At a Gross level, R&D spends in Q2 were Rs 113 Cr. Commenting on the quarterly performance and highlights, Chairperson and Managing Director, Kiran Mazumdar-Shaw stated, "Our performance in Q2 FY17, was led by strong growth across Small Molecules, Biologics and Research Services. Expansion of our biologics footprint in emerging markets and licensing agreements boosted the revenue further. Our ready-to-use Insulin Glargine pen launched in Japan has been well received which augurs well for this business. The acceptance of our proposed biosimilar Trastuzumab filing for review by EMA was a critical milestone this quarter. This is our second filing in EU. The tentative USFDA approval for Rosuvastatin calcium tablets heralds our entry into the US generics market." She added, "Our long term investments in R&D, manufacturing facility in Malaysia and clinical advancement of our programs will enable us to unlock greater value, going forward." ]]> <![CDATA[Exclusive: Prof. Rajat Moona, Director General, C-DAC speaks to BioSpectrum on Digital healthcare]]> https://biospectrumindia.com/views/95/8628/exclusive-prof-rajat-moona-director-general-c-dac-speaks-to-biospectrum-on-digital-healthcare.html https://biospectrumindia.com/views/95/8628/exclusive-prof-rajat-moona-director-general-c-dac-speaks-to-biospectrum-on-digital-healthcare.html Thu, 20 Oct 2016 12:58:00 +0530 Information technology is a fast moving area and so is the healthcare today. healthcare dependence on ICT has changed drastically and I think it is important to realize that ICT can bring wonders into Healthcare and therefore if we take aggressive stands on that move fast into that and do lot of investment into this it can change the face and focus on the healthcare in the country. Newer things, newer virus, newer bacteria protections against them all of these can be done much faster and much better way. Many innovative things can be tried out and therefore it is important that we check and look at where we are and take new steps more aggressively it will be a good idea for the future in the healthcare. ]]> <![CDATA[Sun Pharma, ICGEB to develop novel dengue vaccine]]> https://biospectrumindia.com/news/95/8627/sun-pharma-icgeb-to-develop-novel-dengue-vaccine.html https://biospectrumindia.com/news/95/8627/sun-pharma-icgeb-to-develop-novel-dengue-vaccine.html Thu, 20 Oct 2016 11:33:52 +0530 International Centre for Genetic Engineering and Biotechnology (ICGEB) and Sun Pharma has announced their new collaboration for development of a dengue vaccine, targeted against all the four serotypes of Dengue virus that cause disease in humans. ICGEB has developed a tailored recombinant virus-like-particle (VLP) based tetravalent dengue vaccine, containing host-receptor binding domain of envelope protein of all the four DENV serotypes. ICGEB has conducted pre-clinical studies over the past seven years and developed the existing Know-How and Patents for this dengue vaccine candidate. This is the second collaboration between Sun Pharma and ICGEB focusing on dengue. The first one announced in May 2016 was related to the development of a botanical drug for treatment of Dengue. The current collaboration is focussed on developing a novel, safe & effective vaccine for the prevention of dengue. Initial findings of ICGEB's Dengue vaccine indicate that the candidate induces serotypespecific non-cross-reactive and strongly neutralizing antibodies without disease enhancing concerns. These features of the candidate vaccine differentiate this vaccine development programme from other vaccine programs that are developed or in development globally. This vaccine development will focus on suitability for all target population whether previously affected or non-affected, including paediatric and adults and traveller population. Commenting on the new collaboration signed with ICGEB, Mr Kirti Ganorkar, Executive VP & Head, Global Business Development, Sun Pharma, said, "Our new collaboration with ICGEB for developing an affordable dengue vaccine is part of our broader commitment for developing new and improved vaccines and drugs against flaviviruses that are of significant health importance to India and rest of the world. Our decision to partner with ICGEB on dengue vaccine program followed extensive due diligence and expert consultations on existing dengue vaccine programs globally." According to Dr Salunke, Director - International Centre for Genetic Engineering and Biotechnology (ICGEB), "Despite recent approval of a dengue vaccine and several candidates being at advance stage of clinical trials, the development of a safe, affordable and efficacious dengue vaccine still faces major challenges. I am pleased that the Dengue Vaccine Development program led by Dr. Navin Khanna at ICGEB is now proceeding to clinical development phase with Sun Pharma. The initial support from DBT and subsequent funding from Wellcome Trust has enabled ICGEB to bring this vaccine candidate at the stage it is today. We acknowledge the continued support of DBT and Wellcome Trust for these efforts at ICGEB. Our pre-clinical data is very encouraging and this could be an idealdengue vaccine candidate for all target populations." According to the agreement signed today, Sun Pharma will fund & support further development of the vaccine candidate and existing ICGEB Know-How and Patents. ICGEB will grant Sun Pharma exclusive rights and licenses for development and commercialisation of this vaccine globally. ICGEB will receive pre-defined royalty & milestone payments. A joint development committee, comprising members of both the organisations, will be established to provide oversight to the dengue vaccine development program. According to the agreement signed, ICGEB shall disclose and make available to Sun Pharma all such existing ICGEB Know-How as well as effective completion of technology transfer by ICGEB to Sun Pharma within stipulated timeframe. Since, ICGEB is not related to promoter/promoter group/ group companies of Sun Pharma, this transaction does not fall under related party transaction. Sun Pharma will set-up a Dengue Vaccine Advisory group to provide technical and regulatory support to the vaccine development programme. It will also be exclusively responsible for all Regulatory filings for the product globally including, without limitation, CDSCO-India, WHO, USFDA, EMA, MHRA etc. The company will explore commercialisation opportunities to provide this vaccine to patients across India, Emerging Markets, Western Europe, Japan and USA at affordable costs post Regulatory approvals in these markets. The immediate priority of this partnership is to complete the Toxicology studies for further development of the program. Sun Pharma invests over $300 million annually on research and development in pharmaceuticals and biologics. The Company will use its in-house expertise as well as expertise of its Associate company, ARTES Biotechnology GmbH, in development of dengue vaccine. ARTES will add their experience and proprietary know-how in production of VLP based vaccines from yeast production cell lines. Hep-B and HPV vaccines developed by ARTES are licensed to several companies worldwide and a Malaria vaccine program is sponsored by PATH (Malaria Vaccine Initiative). ]]> <![CDATA[J&J opens new global services center ]]> https://biospectrumindia.com/news/95/8626/jj-opens-new-global-services-center-.html https://biospectrumindia.com/news/95/8626/jj-opens-new-global-services-center-.html Thu, 20 Oct 2016 11:33:30 +0530 Johnson & Johnson (J&J) officially opened the doors of the new Johnson & Johnson Global Services delivery center in Tampa, Florida, fulfilling the commitment the company announced in August 2015 to establish their best-in-class site in the state. The new 88.5 thousand square foot building is a state-of-the-art facility that opens with 240 Johnson & Johnson Global Services employees. By 2020 the company expects to locate 540 people in the center. Johnson & Johnson chose Tampa as its North America hub due to the availability of highly educated talent in the fields of Finance, Operations, Information Technology, Procurement and Human Resources. "We celebrate opening this new center as the latest advancement in the proud history of the world's largest and most broadly-based health care company," said Erin Champlin, Vice President of Johnson & Johnson Global Services. "This new center expands our strong business presence within the state of Florida and we are excited to be a more active member of this vibrant Tampa community." ]]> <![CDATA[AIIMS expands cancer care ]]> https://biospectrumindia.com/news/95/8623/aiims-expands-cancer-care-.html https://biospectrumindia.com/news/95/8623/aiims-expands-cancer-care-.html Wed, 19 Oct 2016 10:56:37 +0530 Elekta (EKTA-B.ST) announces that All India Institute of Medical Science (AIIMS) will acquire seven Versa HD linear accelerators and six microSelectron brachytherapy systems. The investment supports AIIMS's current phase of sustained expansion, which represents India's largest public investment in health sector. The agreement also includes Elekta's Monaco treatment planning system and MOSAIQ radiation oncology information system, as well as service for both hardware and software. Charles Schanen, Senior Vice President, Region Asia Pacific says, "We are very happy to support AIIMS as it introduces sophisticated cancer treatment technology to treat this widespread disease." "Versa HD, the most advanced linear accelerator, will be an excellent asset as it is capable of delivering stereotactic body radiotherapy (SBRT) and radiosurgery (SRS). Cervical cancer is ranked as the most frequent type for women in India. Brachytherapy (internal radiotherapy) is one of the most common methods used to treat cancer of the cervix and our microSelectron remote afterloading platform should benefit thousands of Indian women suffering from this cancer." Every year approximately 4,000 new patients consult AIIMS to receive various radiotherapy treatments. Elekta's agreement with AIIMS covers seven sites across India. Manikandan Bala, Managing Director for Elekta in India says, "According to the International Agency for Research on Cancer, India has more than one million new cancer cases every year. However, the country is making great progress in developing its cancer care and we are honored that AIIMS has chosen Elekta to contribute to this. This agreement demonstrates Elekta's commitment to making radiation therapy available where it is needed most." The order was booked in the second quarter of Elekta's fiscal year and the first shipments will begin in March 2017. ]]> <![CDATA[Enabling talented needy students in Mumbai ]]> https://biospectrumindia.com/news/95/8618/enabling-talented-needy-students-in-mumbai-.html https://biospectrumindia.com/news/95/8618/enabling-talented-needy-students-in-mumbai-.html Tue, 18 Oct 2016 11:27:41 +0530 Merck, a leading science and technology company, has announced that it has presented 89 talented students from underprivileged families in Mumbai with a study scholarship from the Merck India Charitable Trust (MICT), that will support them from Std XI until graduation, covering a period of 5-7 yrs of education. The scholarship amount of Rs 35000/- per student per year will support the study fees, study material and additional coaching that students would require during their graduation in professional courses like engineering and medicine or arts and science courses. The students from underprivileged families in Mumbai were selected on the basis of their high scores in Std. 10 and their scores in the aptitude test conducted by Merck. With the addition of 89 students in 2016, the scholarship will now support 225 students including a visually impaired student, in Mumbai. Talking about the scholarship program Anand Nambiar, Managing Director, Merck India said, "With this scholarship Merck is nurturing the future of the nation. We believe that talent should not suffer from the lack of resources and go futile in the struggles for a respectable life. This is why we have made a long term commitment of financial support to these talented students who are starting a new phase in their education. Merck wishes the new batch of MICT Scholars a successful future" MICT scholarship was constituted by Merck Limited in 2005. The primary objective of the program is to encourage talented under-privileged students to pursue higher education and prevent them from dropping out of academics due to lack of financial resources. 54 students have already passed out with the help of this program and got successfully employed in prestigious Indian multinational firms in IT, medicine and other fields. The records of these students over the years reveal almost nil drop outs from the scholarship program. The program started with 40 students and have now grown to 225 students in Mumbai and 50 students in Goa. ]]> <![CDATA[FDA nod for Cipla's new generic ]]> https://biospectrumindia.com/news/95/8540/fda-nod-for-ciplas-new-generic-.html https://biospectrumindia.com/news/95/8540/fda-nod-for-ciplas-new-generic-.html Tue, 18 Oct 2016 11:27:04 +0530 Cipla Limited has received final approval for its Abbreviated New Drug Application (ANDA) for Darifenacin Extended-Release Tablets, 7.5mg and 15mg, from the United States Food and Drug Administration (USFDA). Darifenacin Extended-Release Tablets, 7.5mg and 15mg, are AB-rated generic equivalents of Allergan's Enablex Tablets, 7.5mg and 15mg, and are a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency and frequency. The product will be launched immediately. Enablex Tablets and generic equivalents had U.S. sales of approximately $85M for the 12 month period ending June 2016, according to IMS Health. ]]> <![CDATA[Pall Life Sciences launches Kleenpak Presto sterile connectors]]> https://biospectrumindia.com/news/95/8617/pall-life-sciences-launches-kleenpak-presto-sterile-connectors.html https://biospectrumindia.com/news/95/8617/pall-life-sciences-launches-kleenpak-presto-sterile-connectors.html Mon, 17 Oct 2016 11:08:21 +0530 Pall Life Sciences, a division of global filtration, separation and purification leader Pall Corporation, announces the launch of the Kleenpak Presto sterile connector to be used in a wide range of applications in upstream, downstream, and formulation and filling. "We launched the Presto genderless sterile connector family in direct response to customer demand for a reliable, robust universal single-use fluid handling solution," said the company's President of Single Use Technologies, Mario Philips. "With its intuitive operation and easy to use features - we worked closely on this new generation design with our customers to ensure even greater levels of sterility assurance." The Kleenpak Presto sterile connector is a genderless technology for the sterile connection of two fluid paths even in uncontrolled environments. The connectors are available in ¼ in., â…œ in., ½ in. and â…? in. hose barb sizes, and with ½ in. sanitary connections, and are made from Bisphenol-A free polyethersulfone. The connectors can be used for a wide range of applications and are 100% inspected at point of manufacturer with device traceability and serialization linked to this 100% quality control process. ]]> <![CDATA[Cipla receives EIR from the FDA for its Indore facility]]> https://biospectrumindia.com/news/95/8616/cipla-receives-eir-from-the-fda-for-its-indore-facility.html https://biospectrumindia.com/news/95/8616/cipla-receives-eir-from-the-fda-for-its-indore-facility.html Mon, 17 Oct 2016 11:07:26 +0530 Cipla Limited announced that it has received Establishment Inspection Report (EIR) from the US FDA for its Indore facility indicating formal closure of the US FDA inspection conducted in July/August, 2015. Cipla is a global pharmaceutical company which uses cutting edge technology and innovation to meet the everyday needs of all patients. For over 80 years, Cipla has emerged as one of the most respected pharmaceutical names in India as well as across more than 100 countries. The Company's portfolio includes over 1000 products across wide range of therapeutic categories with one quality standard globally. Cipla's research and development focuses on developing innovative products and drug delivery systems. ]]> <![CDATA[India urges Japan to provide wider pharma market access ]]> https://biospectrumindia.com/news/95/8613/india-urges-japan-to-provide-wider-pharma-market-access-.html https://biospectrumindia.com/news/95/8613/india-urges-japan-to-provide-wider-pharma-market-access-.html Fri, 14 Oct 2016 14:02:00 +0530 Singapore: The Indian commerce Minister, Ms Nirmala Sitharaman has urged Japan to provide Indian pharmaceutical sector with a wider share and greater market access in Japan. Ms Sitharaman further pointed out that the share of India in the Japanese drug market continued to be below par and limited mostly to active pharmaceutical ingredients (or APIs - raw materials for drugs). She said the demand for generic medicines in Japan and India's capability to meet this demand can prove a win-win for both countries. An official statement by Ms Sitharaman read, "The Japanese pharmaceutical market offers a huge untapped potential for Indian pharma industry. India's strength in pharma sector is well established. This, coupled with the decision of Government of Japan towards attaining an 80 per cent share of generic medicines by 2018, should provide an opportunity for the generic drug industry of India," She further said that Indian companies should use the India-Japan Comprehensive Economic Partnership Agreement (CEPA) much more to boost exports to Japan, she said at a seminar organised by think-tank RIS. The minister expressed concern over India's trade deficit with Japan increasing from $3.1 billion before the CEPA was inked in 2011 to $5.2 billion thereafter. She said there was a need to address implementation issues of CEPA. For example, she said, Japan had accorded preferential tariff to fish surimi from India. A negligible amount of an imported cryo-protectant, TSPP, is applied for preservation. Though the value of the TSPP is less than 0.5 per cent of the overall product cost, it is precluded from CEPA benefits as the 'product is not of Indian origin', she pointed out. Japan and India are the second and third largest economies in Asia. The economic engagement witnessed significant rise after both countries signed a Comprehensive Economic Partnership Agreement (CEPA) in 2011. The trade between the two countries pre-CEPA in 2010 was USD 10.4 billion and currently it stands at USD 14.5 billion. Trade deficit with respect to Japan was USD 3.1 billion pre-CEPA, and now it is USD 5.2 billion. ]]> <![CDATA[India requests 'Green Channel' for export of drugs to China]]> https://biospectrumindia.com/news/95/8610/india-requests-green-channel-for-export-of-drugs-to-china.html https://biospectrumindia.com/news/95/8610/india-requests-green-channel-for-export-of-drugs-to-china.html Fri, 14 Oct 2016 14:00:00 +0530 Singapore: With a view to bridge the increasing trade gap between the two countries, Chinese vice Minister of finance and commerce Mr Wang Shouwen said that the country will act on the concerns expressed by India and give greater market access to domestic products. The Chinese minister is here to attend the 6th BRICS Trade Ministers' meeting. In recent meeting held in India's national capital, Delhi, Ms Nirmala Sitharaman raised concerns over the widening trade deficit between the two countries. Both the leaders exchanged notes on trade and commerce and agreed that the "mounting bilateral trade deficit has been a cause for concern for India" which seeks greater market access for its goods for a long-term sustainable trade relationship, explained the officials. India's exports to China were at $9 billion in 2015-16, imports were $61.7 billion, leaving a trade gap of $52.7 billion. Ms Sitharaman requested expeditious clearances for import of Indian rice besides a 'Green Channel' for import of Indian pharmaceutical products to China - especially those which already have US FDA and EU FDA accreditation. Ms Sitaraman also mentioned that the long drawn procedures for clearances tend to frustrate the Indian companies seeking business opportunities in China and hence she urged the country to speed up its approval and clearance processes. The Chinese Minister said that recently China has quickened the pace of granting clearances to Indian pharma companies for import of the pharma products. She also requested the Chinese vice-minister to consider demonstration IT/ITeS projects for Indian companies, which have acquired global acclaim, an official statement issued after the meeting said. The Chinese vice minister also sought cooperation of India on various multilateral fora where China and India are engaged and assured that India's concerns on a 'Single undertaking' will be duly taken on board with services being an integral part of the cooperation agreement. ]]> <![CDATA['India is sitting on a psychological disordered time bomb']]> https://biospectrumindia.com/features/95/8614/india-is-sitting-on-a-psychological-disordered-time-bomb.html https://biospectrumindia.com/features/95/8614/india-is-sitting-on-a-psychological-disordered-time-bomb.html Fri, 14 Oct 2016 14:00:00 +0530 Singapore: Despite of escalating number of mental health patients in the country, the subject of mental health illness, is still by and large a taboo topic for several Indians. World Health Organisation (WHO) estimated that globally over 450 million people suffer from mental disorders. Mental health is a complex and sensitive subject that needs to be addressed with compassion and knowledge. Stigma towards, and discrimination against, people with mental disorders is an important barrier to mental health service utilization in India. It contributes to delay in seeking care, impedes timely diagnosis and treatment for mental disorders, serves as an impediment to recovery and rehabilitation, and ultimately reduces the opportunity for fuller participation in life. Dr Kersi Chavda, Consultant Psychiatrist P.D.Hinduja National Hospital, Hinduja Healthcare Hospital and Sir HNRF Hospital and Past President of the Bombay Psychiatric Society, explained, "As a society prospers and the daily necessities of living are taken care of....there occurs a shift towards ensuring mental or psychological well being. Given that most studies that have been done in the field estimate that about a percentage of any population suffers from psychological disorders...this implies that in huge populations such as in India...there will be about 50 million affected people. Of these, it is estimated that half of the "severe" disorders are not dealt with (Schizophrenia, bipolar disorders, major depression), while in the "Milder disorders" the amount might be as much as 9 in 10!!!" The Word Health Organization describes mental health as an integral part of health and well-being. As reflected in the definition of health in the Constitution: "Health is a state of complete physical, mental and social well-being and not merely the absence of disease or infirmity." Good mental health enables people to realize their potential, cope with the normal stresses of life, work productively, and contribute to their communities.WHO statistics say the average suicide rate in India is 10.9 for every lakh people. Interestingly, doctors observe that suicide rate was higher among the southern States compared to those in the north. It is the second leading cause of death among those in the age group of 18-29, and most suicides in India are by those below 44 years. Dr Chavda pointed out that India has the largest child/ adolescent population in the world, as well as the largest aging population.....given that the prevalence of psychological disorders in kids is estimated between 9.4 to 12.5 percent, this gives us a huge number of kids that need mental health services. The same is seen in the aging disorders (dementia, Alzheimer's)....and we can see that India basically is sitting on a psychological disordered "time bomb"!!! Recently, India unveiled its first mental health policy, which aims to reduce the treatment gap by providing universal access to mental healthcare through increased funding and human resources. However the policy is not implemented well. Dr Chavda underscores, "The number of mental health professionals in India show an extremely depressing trend...there are about 4000 psychiatrists, 1000 psychologists and 3000 psychological Social workers in the whole of India!! Not surprisingly, most people with mental/psychological issues, even if desirous of getting help, do not know where to go." Social stigma remains an obstacle to helping Indians cope with mental health illness. There is widespread belief that mental illness is a punishment for the ancestors' misdeeds on the present generation, effectively shaming several generations of the family simultaneously. And society contributes a lot to keep the stigma alive by discouraging conversation about mental well-being issues among their children, grandchildren, students and other members of the community. Dr Chavda outlines, "The stigma of mental health, although often related to context rather than to a person's appearance, remains a powerful negative attribute in all social relations. There occurs a sense of shame, a sign of indulgence, a sign of weakness. This also causes a feeling of embarrassment in the family, and then a desire for isolation. Thus, unlike in physical illnesses, wherein social resources are mobilized, people with mental issues are removed from potential supports. The reality of discriminatory practice supplies a very real incentive to keep mental health problems a secret. Discrimination is seen to occur across every aspect of social and economic existence. A feeling of helplessness and hopelessness is often experienced." Dr Chavda said that there are a number of stereotypes of mental disorders which perpetuate the stigmatization. For instance, it is assumed that mentally ill people are violent or prone to criminal acts, are hard to communicate with, over privileged, narcissistic, oversexed parasites. Society blames these people that the problems they suffering are self-inflicted. Many also believe that it is a result of "fate" or "karma." Movies also have a big impact on the way people see mental illness. Many also think that the perceived treatments are incurable/chronic and very expensive and long drawn-out." More than funding and resources a change in the attitude of people is needed to build a healthy mentally fit society. In India there is a need to generate evidence base for context specific interventions that will address negative attitudes towards people with mental disorders and ensure implementation of these interventions by involving users, care-givers, community health workers and mental health service providers. Dr Chavda highlighted, " Few ways to reduce stigmatization include education as the level of stigmatization reduces with increasing education, use of the press, net, media to correctly portray the disorders, target families , schools and communities to start mental health early intervention programmes...the more these issues are talked about, the more likely it is that people will become more sensitive to these issue, advocacy and use of legalities. Starting insurance for the mentally ill...currently no insurance is allowed and hence people find it extremely expensive to treat the issue. Getting well known people to talk about how they coped with psychological disorders, e.g. if a sportsperson or film star talks about how they coped with a psychological issue they experienced...it makes the public believe that it is ok to have it and deal with it ." India has a National Mental Health Programme since 1982. In 1996, a component of a community based approach called the Bellary Model (District Mental Health Programme) was added to this. Apart from strengthening manpower capacity or strengthening capacity of health workforce, focus is also on addressing the mental health issue in schools and colleges, workplaces and counselling for suicide prevention. India launched its first Mental Health Policy and the Mental Health Action Plan 365 in 2014 to promote mental health, prevent mental illness, enable recovery from mental illness, promote destigmatization and desegregation and ensure economic and social inclusion in rights-based framework. Various psychiatric societies like the The Bombay psychiatric Society, The Indian Psychiatric Society, The Indian Association of Private Psychiatry, etc in the various states of India and abroad are attempting to disseminate information, provide information about recent advances, and banish the ignorance associated with various disorders. Associations related to particular disorders have also been established which deal specifically with issues ...e.g. Maharashtra Dyslexia Association, The Spastics Society, etc. Self help groups, which provide support to care givers of patients with the disorders, e.g. Al -Anon or Gamblers Anonymous, play an important role in providing support as well...this is usually through NGOs and private organisations rather than governments. Dr Chavda concluded, "The government in India, with its Mental Health Acts, as well as its separate laws dealing with child/ spousal and elder abuse, as well as suicide and deaddictions, is attempting to address the situation. However, a lot of work needs to be done before the mentally affected in India are treated the way that they deserve." ]]> <![CDATA[Dr. Reddy's new generic is now available in the US]]> https://biospectrumindia.com/news/95/8611/dr-reddys-new-generic-is-now-available-in-the-us.html https://biospectrumindia.com/news/95/8611/dr-reddys-new-generic-is-now-available-in-the-us.html Fri, 14 Oct 2016 10:59:51 +0530 Dr. Reddy's Laboratories announced that it has launched Aripiprazole tablets, USP, in 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg, a therapeutic equivalent generic version of Abilify (aripiprazole) tablets in the United States market approved by the U.S. Food & Drug Administration (USFDA). The Abilify brand and generic tablets had U.S. sales of approximately $3.1 billion MAT for the most recent twelve months ending in August 2016 according to IMS Health. Dr.Reddy's Aripiprazole tablets 2 mg, 5 mg, 10 mg, 15 mg, 20 mg, and 30 mg are available in bottle count sizes of 30. Abilify is a registered trademark of Otsuka Pharmaceutical Company. ]]> <![CDATA[Glenmark appoints Dr. Kurt Stoeckli as President and Chief Scientific Officer]]> https://biospectrumindia.com/news/95/8608/glenmark-appoints-dr-kurt-stoeckli-as-president-and-chief-scientific-officer.html https://biospectrumindia.com/news/95/8608/glenmark-appoints-dr-kurt-stoeckli-as-president-and-chief-scientific-officer.html Fri, 14 Oct 2016 10:59:32 +0530 Glenmark has announced the appointment of Dr. Kurt Stoeckli as President and Chief Scientific Officer (CSO). Dr. Stoeckli joins Glenmark from SANOFI where he was Group Vice President, Global Biopharmaceuticals Division & Chief Scientific Officer for R&D France. He will report to Glenn Saldanha, Chairman and MD and will be based out of NeuchÃ¢tel, Switzerland. He will also be President and General Manager of Glenmark's Switzerland-based business units. Dr. Stoeckli will lead the company's global research portfolio consisting of NBE, NCE, generics and branded formulations. He will be responsible for sustaining and enhancing the environment of collaborative research and for driving successful commercialization of Glenmark' research pipeline in partnership with other leaders. "We are pleased to bring Dr. Stoeckli's expertise to Glenmark which will further drive the advancement of our new molecular entity portfolio and enable us to continue discovering NMEs both small molecules and biologics," said Glenn Saldanha, Chairman and MD, Glenmark Pharmaceuticals Ltd. "Dr. Stoeckli's invaluable scientific knowledge and leadership will enable us to achieve our goal of becoming a global innovative pharmaceutical organisation." Having spent more than two decades in the pharmaceutical industry, Dr. Stoeckli has an extensive industry experience in driving biologics from early research up to phase 3. He has played a pivotal role in fostering and managing Sanofi's JV with Regeneron Pharmaceuticals Inc. During his 15 year tenure at Sanofi, he was a member of global R&D board and held global leadership positions as Head of the Therapeutic Unit Immunology & Inflammation, VP Biological Sciences & Scientific Site Director of the R&D Centre in Paris-Vitry (France) and VP Lead Discovery for small molecules research, based in Frankfurt (Germany). Dr. Stoeckli's achievements include the successful leadership of scientific teams responsible for discovery and development of both NBEs and NCEs. Under his leadership, more than 20 projects advanced to clinical stage (ranging from Ph1 through Ph3) in the areas of autoimmune and inflammatory disorders, and oncology. Graduating from the Biocenter of University of Basel, ETH Zurich and Max-Planck-Institute (Munich), Dr. Stoeckli was a Postdoctoral Fellow and Assistant Professor at the Department of Biochemistry & Biophysics, University of California Medical Center (UCSF) before he started his career in industry at Novartis/Sandoz Pharma AG in Basel, Switzerland. Glenmark's previous President and CSO, Dr. Michael Buschle, will have a new role as Chief Scientific Mentor and will continue to provide strategic and scientific direction to Glenmark's Worldwide Drug Discovery Programs and pharmaceutical development Dr. Buschle will work directly with Mr. Glenn Saldanha. ]]> <![CDATA[Boehringer Ingelheim India and Lupin announce strategic co-marketing agreement]]> https://biospectrumindia.com/news/95/8612/boehringer-ingelheim-india-and-lupin-announce-strategic-co-marketing-agreement.html https://biospectrumindia.com/news/95/8612/boehringer-ingelheim-india-and-lupin-announce-strategic-co-marketing-agreement.html Thu, 13 Oct 2016 17:42:29 +0530 Boehringer Ingelheim and pharma major Lupin Limited announced another strategic alliance to co-market Empagliflozin, a novel sodium glucose co-transporter-2 (SGLT-2) inhibitor in India. Boehringer Ingelheim and Lupin had earlier signed a partnership for Co-Marketing Linagliptin in October 2015. The inclusion of Empagliflozin is a significant addition to the partnership. SGLT-2 Inhibitors are a novel class of drugs that were launched across the world in the last couple of years. According to the agreement, Lupin will market and sell Empagliflozin under a separate brand name Gibtulio which will be promoted by Lupin's specialty field force. Boehringer Ingelheim will continue to sell Empagliflozin under the brand name Jardiance through their existing sales force and network. Gibtulio and Jardiance tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. They are available in 10 mg and 25 mg strength. The Indian diabetes market is valued at INR 9,003 Crore, growing at 19.5% (IMS MAT July 2016). The market has been driven largely by the entry of newer drugs like DPP-4 Inhibitors over the last 6 years and the SGLT-2 Inhibitors are expected to outgrow & outpace the market faster than before. The SGLT-2 Inhibitors were first introduced in India in March 2015 and the total SGLT-2 Inhibitors market is valued at INR 113 Crore and growing at 880.17% (IMS MAT July 2016). India is known as the Diabetes capital of the world with 69 million people being diabetic - 5% of the country's population and an estimated 1.02 million deaths are caused due to high blood sugar in India. Type 2 diabetes is expected to increase to 87 million by 2030. Lupin is the 4th largest company in the Anti-Diabetes segment and currently has 6.7% market share of the overall Diabetes market. Lupin also has the distinction of being the only company in the Anti-Diabetes Market with a contemporary portfolio comprising of Oral Anti-Diabetes Drugs (OAD) and Injectable Drugs like Conventional Insulin and Insulin analogues. Lupin's Anti-Diabetic portfolio contributes 11% to its India formulations sales. Announcing the launch, Mr. Shakti Chakraborty, Group President, India Region Formulations, Lupin said, "We are happy to expand our partnership with Boehringer Ingelheim to combat the growing menace of Diabetes in India. I believe our entry into the fast growth SGLT-2 Inhibitors market with the launch of Gibtulio will further strengthen our overall Diabetes portfolio and consolidate our position as a market leader and the fastest growing player in the TOP 5 in the Anti-Diabetes segment within the Indian Pharmaceutical Market." Mr. Sharad Tyagi, Managing Director, Boehringer Ingelheim India said: "We are pleased to strengthen our partnership with Lupin for the sales and promotion of Empagliflozin. This partnership shows our commitment towards addressing challenges in diabetes management in India by providing broader access to innovative medicine. Through its research and scientific excellence, Boehringer Ingelheim India will continue to introduce innovative products to address the unmet patients' needs amidst the growing Indian diabetes epidemic." ]]> <![CDATA[Aurobindo Pharma plans to raise $500 million funding]]> https://biospectrumindia.com/news/95/8609/aurobindo-pharma-plans-to-raise-500-million-funding.html https://biospectrumindia.com/news/95/8609/aurobindo-pharma-plans-to-raise-500-million-funding.html Thu, 13 Oct 2016 14:29:51 +0530 Hyderabad-based Aurobindo Pharma Ltd. is looking at raising aroind $500 million fund to buy two companies in Europe. According to DealCurry fundraising could be a combination of foreign currency convertible bonds and private equity to the tune of $300 million and $200 million respectively. Aurobindo Pharma is currently in talks for buying a Spain and the UK companies. The planned acquisitions will help the company increase its revenue to $3 billion in two years from the currently reported $2.1 billion in fiscal 2016. Recently, Aurobindo Pharma has submitted its bid for Israeli majors Teva's UK and Irish portfolios. ]]> <![CDATA[Piramal to buy Janssen's injectable anesthesia and pain management products]]> https://biospectrumindia.com/news/95/8607/piramal-to-buy-janssens-injectable-anesthesia-and-pain-management-products.html https://biospectrumindia.com/news/95/8607/piramal-to-buy-janssens-injectable-anesthesia-and-pain-management-products.html Thu, 13 Oct 2016 10:49:50 +0530 Piramal Enterprises announced that its wholly owned Critical Care subsidiary in the UK has entered into an agreement to acquire five anesthesia and pain management injectable products from Janssen Pharmaceutica NV, in an all cash deal for an upfront consideration of $155 million, and up to an additional US$20 million. The products to be acquired are five injectable versions of well-established Janssen brands, Sublimaze (fentanyl citrate), Sufenta(sufentanil citrate), Rapifen (alfentanil hydrochloride), Dipidolor (piritramide), and Hypnomidate (etomidate) (the "Products"). Piramal has agreed to acquire the brand names and all related IP as associated with the Products, including the know-how to make both the active pharmaceutical ingredients ("API") and the finished dosage forms of the Products. The Products are currently marketed in over 50 countries. The potential acquisition does not include the transfer of any manufacturing facilities or employees. As part of the transaction, Janssen will continue to supply finished dosage forms for up to three years and API for up to five years. Janssen will continue to sell the products on behalf of Piramal until the marketing authorizations or relevant business relations are transferred to Piramal. Janssen can earn up to an additional $20 million if the Product portfolio achieves certain agreed financial milestones over the next 30 months. The transaction is expected to close this week. Commenting on the occasion, Ajay Piramal, Chairman, Piramal Enterprises said, "Healthcare is an important focus area for Piramal Enterprises and we are strongly committed to growing this segment. The healthcare segment has grown at 17% CAGR over the last five years. This would be our 6th healthcare acquisition in the last two years, inorganically investing Rs. 1,800 crores across our Healthcare businesses. This acquisition is critical in shaping our product offerings, providing access to global markets and leveraging our existing capabilities. This acquisition is an important step in enabling Piramal Critical Care to start to address the global generic injectable hospital drug market which is greater than S$20 billion in size. At Piramal, we constantly focus on creating long term value for our shareholders." Peter DeYoung, CEO - Piramal Critical Care said, "We are currently the third largest player in the Inhalation Anesthesia market globally and continue to grow in that niche segment. These injectable anesthesia and pain products are a terrific addition to our existing portfolio that will allow us to provide greater value to our customers leveraging our existing organisation and distribution partners. Four of the acquired products are controlled substances which have higher barriers to entry. Once the business is fully transitioned to us, our customers and business partners will benefit from our broader product basket, and in turn we can grow the value of the acquired product portfolio through our team's focused sales and marketing efforts. We remain committed to pursue additional value enhancing organic and inorganic opportunities in the future. " The completion of the transaction is not subject to any further regulatory approvals. ]]> <![CDATA[IIT Ropar joins hands with IIT Mandi & PGIMER to establish Bio-X Consortium]]> https://biospectrumindia.com/news/95/8606/iit-ropar-joins-hands-with-iit-mandi-pgimer-to-establish-bio-x-consortium.html https://biospectrumindia.com/news/95/8606/iit-ropar-joins-hands-with-iit-mandi-pgimer-to-establish-bio-x-consortium.html Thu, 13 Oct 2016 10:49:31 +0530 The Indian Institute of Technology (IIT), Ropar is collaborating with IIT Mandi and PGIMER, Chandigarh to establish a Bio-X Consortium, which will address all big challenges in the fields of healthcare and medicine. All three institutes are signing a 3-way MoU to join hands with a common goal of disease prevention and affordable health care in India. The consortium is the brainchild of Prof. S.K Das, Director of IIT Ropar who initiated this project along with the Director of IIT Mandi, Prof. Timothy A. Gonsalves and PGIMER, Chandigarh to facilitate and encourage collaboration between engineering and technological experts and develop low cost diagnostics and therapy for prevalent diseases which have been affecting a large number of population in India. Bio-X consortium is poised to tackle the complex challenges in medicine with an interdisciplinary outlook. Based on the common strengths of the collaborating institutes, current focus areas of the consortium include (but not limited to): Biomedical Imaging, Biomechanics, Biomedical Nanotechnology, Biomedical Instrumentation and Cancer Diagnostics & Therapy. The directors of IIT Ropar and Mandi have agreed to support the consortium by providing the required seed money in form of grants, contributing to 10% of the total project cost. The seed funding will be given to projects with significant potential to initiate preliminary study opportunities and also at a later stage attract additional external funding. Currently 3 out of the 6 projects presented during initial discussions have been awarded seed grants totaling to Rs. 48 lacs. The three projects are in the field of Developing low cost low magnetic field MRI; Determination of Mechanical and Biological Osteoporotic Bone; &Surface modified upconversion nanoparticles for theranostic applications in cancer. All three projects are progressing smoothly with preliminary work/experiments underway and are expecting to apply for extramural funding within one year. Speaking about the collaboration, Prof. S.K. Das, Director of IIT Ropar said, "This consortium is a result of months of discussions and meetings between the institutes. We aimed to develop a conglomerate or a system, where we could encourage the technological talent and experts to develop affordable medical devices and diagnostic therapies for the various wide spread diseases in India. The success of this consortium will bring a revolution in medical technology and we will enable us to provide low cost healthcare & diagnostics to the large population of India. " ]]> <![CDATA[Systems solutions to fight vector borne disease outbreaks ]]> https://biospectrumindia.com/features/95/8605/systems-solutions-to-fight-vector-borne-disease-outbreaks-.html https://biospectrumindia.com/features/95/8605/systems-solutions-to-fight-vector-borne-disease-outbreaks-.html Wed, 12 Oct 2016 13:04:24 +0530 The advent of monsoon across the Indian subcontinent signals the annual spikes in vector borne diseases, namely dengue and chikungunya. This year, with over 12,000 cases of chikungunya nationwide, and over 1000 cases of dengue in the national capital alone , the political and media spotlight is once again on India's ability to control vector borne diseases. Together with malaria, dengue and chikungunya are endemic to India, and their hosts the Anopheles and Aedes mosquitoes thrive in the subtropical and humid climate. Due to high mortality rates, significant attention has been given to tackling Malaria, which is a focus of India's National Vector Borne Disease Control Programme, as well as leading international health financing agencies like the Bill and Malaria Gates Foundation and the Global Fund. Across these national and global initiatives, there is an underlying core of vector control, with the two broadly applicable measures being long-lasting insecticidal nets and indoor residual spraying. An additional, and increasingly important strategy focuses on strengthening health systems to diagnose and treat infectious diseases, which involves not only the capital and human for case detection, but also management and mitigation. Dengue and chikungunya, despite having relatively lower morbidity rates, are significantly debilitating diseases. They are transmitted by the by Aedes mosquitoes, which require warm temperatures and humidity for survival and development, and have entomological adaptations to the environment that make them highly resilient to natural or human control measures. Moreover, their habitat is closely associated with that of humans . A response to a dengue or chikungunya outbreak lies within the purview of the health system, and given the lack of vaccines or treatment options, relies heavily on early diagnosis and symptom management. The onus therefore, lies in outbreak prevention and vector control, and a multi stakeholder approach to containing the growth and development of breeding grounds. The adaptability of the Aeges mosquito requires a review of the enabling drivers of an outbreak. These include urbanization that increases population density and pressure on public infrastructure, lack of sanitation and waste management, ineffective mosquito control and in particular insecticide resistance, and global climate change. The actors required to tackle such a multidimensional challenge are by necessity diverse and cross sectoral. A strong national health system remain the core pillar of disease response. However, close coordination with water and sanitation and urban development sectors are essential for effective elimination of vector breeding areas. In addition, the robust and well entrenched philanthropic and social sector is an important partner, particularly in two areas - (1) facilitating community participation in eliminating breeding grounds and other vector control measures, disease surveillance/screening, and last mile diagnosis, and (2) providing the capital and risk appetite for innovation and cutting edge research. These are high leverage strategies that closely align with national health platforms, while providing agile responses not only to regional heterogeneity, but also the evolving bionomics of the vectors. Such a collaboration is already an emerging norm in the fight against Malaria across India, where grass root civil society works with the front line primary health network to support screening and referrals. The Tata Trusts, India's oldest philanthropy is working closely with high burden states to accelerate case detection , while the Bill and Melinda Gates Foundation is looking into technological solutions, including genetic research, to neutralize vectors . The fight against vector borne diseases in India in larger than the fight against Malaria. One can argue that the Aeges mosquito, which transmits not only dengue and chikungunya, but is also a known carrier of Zika is a significant threat to India. The need of the hour is to approach vector control from a systems perspective instead of a single disease focus, and engage communities and cross-sectoral actors to address key behaviours and practices within communities as well as exogenous drivers that result in vector persistence and outbreaks. By Manisha Bhinge Manisha Bhinge has over twelve years of experience in social innovation, convening and management of multi-stakeholder partnerships and driving evidence-based program strategies. She was most recently Head of Strategic Partnerships at the Tata Trusts, where she launch an innovation fund for TB and Malaria in India. Her background includes working in the international social sector space where she was Vice President of BRAC's North America based affiliate. Her projects have included access to health, inclusive finance and social justice, spanning Sub Saharan Africa as well as South and South East Asia. Manisha is a Rockefeller Foundation Global Social Innovation Fellow. Twitter: @manisha_bhinge ]]> <![CDATA[Story of Twin Brothers - Dengue & Chikungunya]]> https://biospectrumindia.com/features/95/8602/story-of-twin-brothers-dengue-chikungunya.html https://biospectrumindia.com/features/95/8602/story-of-twin-brothers-dengue-chikungunya.html Wed, 12 Oct 2016 12:59:44 +0530 Heartthrob of millions Vidya Balan is down with Dengue and the mosquito from the swimming pool of Shahid Kappor is the real culprit for it. Interesting stuff for a news story with commendable TRP. Nowadays, Dengue is in the news for one or the other reasons. Dengue & Chikungunya are twin brothers sharing one & the same vehicle for their travel. Every year shortly after beginning of monsoon showers, we experience rise in Dengue cases & it occupies coveted place in news headlines, making every other news less important. After their first appearance during 1960s, these twin brothers were almost missing. That is why their reemergence story reminds Manmohan Desai's lost & found Bollywood story in 1980s. History of Dengue World War II has played a vital role in expanding Dengue affected areas. Allied forces might have defeated Germany & Japan; but the real victorious was Dengue virus. Prior to World War II, dengue viruses had a global distribution in the tropics, but as urbanization was quite minimal and the viruses and mosquito vectors was dependent on ocean going vessels for transportation among regions, epidemics were sporadic & that too with long intervals between them. That is why, prior to second World War, Dengue fever was not considered a major public health problem. During World War II, while in Asiatic region, thousands of soldiers from both the sides were affected by Dengue & Malaria. Troop movement & transport of war material has facilitated transportation of Dengue virus & its vector Aedes aegypti to most countries of both the regions. World War II was followed by emphatic economical growth of SE Asia which was vital in the unprecedented urban growth that began in the 1950s and continues today. During this period, first documented epidemics of dengue occurred in the Philippines (1953-1954) and Thailand (1958), Singapore, Malaysia and Vietnam (1960s) and Indonesia and Myanmar(1970s). In India, first epidemic of Dengue was reported from Chennai (Madras) in 1780. But 1964's Kolkata epidemic is the first virologically proved Dengue outbreak of Modern India. Current StatusAs per WHO, "The incidence of dengue has grown dramatically around the world in recent decades. The actual numbers of dengue cases are underreported and many cases are misclassified. One recent estimate indicates 390 million dengue infections per year, of which 96 million manifest clinically (with any severity of disease). Another study, of the prevalence of dengue, estimates that 3.9 billion people, in 128 countries, are at risk of infection with dengue viruses In India, we are observing steady rise of Dengue cases in last decade. Last Year, National Vector Borne Diseases' Control Program (NVBDCP) reported approximately 1 Lac Dengue cases with 220 deaths in entire country. This year up to first week of September respective figures are 36 thousands cases & seventy deaths. But we have to accept these figures with a pinch of salt especially when one report estimates that India has about six million laboratory confirmed Dengue cases annually resulting in an annual economic loss of about 1.11 billion dollars. Maharashtra being one of the most urbanized & developed states, bears maximum brunt of Dengue every year. State has reported maximum cases during 2014. In that year, state has 8500 plus cases & 144 deaths. This year till August, state has reported 2572 cases which are almost double the number as compared with last year's figure of the same period. After 2006's epidemic, Chikungunya is again surfacing in certain areas like New Delhi & Pune. We all must be serious enough while dealing with the Dengue menace. 1996 Dengue outbreak has claimed more than four hundred lives in Delhi alone. Our complacency & short sightedness shall lead to such dire situations again & again. We should not opt for short term measures bypassing long term interventions. Know Dengue for No DengueDengue is a mosquito-borne viral disease. Dengue virus is transmitted by female mosquitoes mainly of the species Aedes aegypti and, to a lesser extent,Ae. albopictus. There are 4 distinct, but closely related, serotypes of the virus that cause dengue (DEN-1, DEN-2, DEN-3 and DEN-4). Recovery from infection by one provides lifelong immunity against that particular serotype. However, cross-immunity to the other serotypes after recovery is only partial and temporary. Symptoms of Dengue are similar to flu. Abrupt onset of Fever, Frontal headache, retro orbital pain, muscle & joint pain, measles like rash over chest & upper limbs, Nausea & vomiting are the common signs & symptoms of Dengue. Dengue Hemorrhagic Fever (DHF) & Dengue Shock Syndrome (DSS) are the major complications of Dengue. Warning signs of severe dengue include abdominal pain or tenderness, persistent vomit¬ing, clinical fluid accumulation, mucosal bleeding, leth¬argy or restlessness, liver enlargement of >2 cm, or an increase in haematocrit concurrent with a rapid decrease in platelet count. There is no specific treatment for Dengue. Symptomatic clinical management is the mainstay of Dengue treatment. Why Dengue is increasing? The very title of an article written by world known Dengue expert Duane Gubler in ' Tropical Medicine & Health' explains rise of Dengue in recent years. The title of this article published in 2011 was 'Dengue, Urbanization and Globalization: The Unholy Trinity of the 21st Century'. Rapid & unplanned urbanization, exponential population growth, inadequate municipal services, increased use of non-biodegradable products (bottles, tyres, plastic cans etc), unprecedented growth in population movement & commodity transport all have contributed to the rise of Dengue. In last 50 years, there is 30 fold rise of Dengue. Dengue & Chikungunia - Similarities & DifferencesChikungunya is caused by the chikungunya virus. This is only single virus, there are no subtypes like Dengue virus. As natural infection gives lifelong immunity, outbreaks of Chikungunya are not as frequent as Dengue. It is observed that, Chikungunya emerges after every 10-12 years, after sufficient non-immune cohort of the population is built up. We have previous epidemic of Chikungunya in 2006. Chikungunya resembles dengue fever, and is characterized by severe, sometimes persistent, joint pain (arthiritis), as well as fever and rash. It is rarely life-threatening. Just like Dengue, there is no specific treatment for Chikungunya. ELISA tests are considered as confirmatory by national authorities, though rampant use of various rapid diagnostic tests without any scientific validation is rule of the day. This adds to already existing chaos. The Six Legged EnemyTo understand how to contain Dengue & chikungunya, we need to know about their vehicle in more details. Aedes aegypti also transmits Yellow Fever & Zika.Aedes is a small, black mosquito with white stripes and is approximately 5 mm in size. It takes about 7 to 8 days to develop the virus in its body and transmit the disease. Aedes is day biter. It mainly feeds on human beings in domestic and peridomestic situations. It rests in the dark corners of the houses, on hanging objects like clothes, umbrella, etc. or under the furniture. Aedes aegypti mosquito breeds in any type of manmade containers or storage containers having even a small quantity of water. Eggs of Aedes aegypti can live without water for more than one year. Desert coolers, Drums, Jars, Pots, Buckets, Flower vases, Plant saucers, Tanks, Cisterns, Bottles, Tins, Tyres, Roof gutters, Refrigerator drip pans, Cement blocks, Cemetery urns, Bamboo stumps, Coconut shells, Tree holes and many more places where rainwater collects or is stored are the favored breeding sites of Aedes mosquito. This explains our responsibility as an individual & as a community in effective containment of aedes breeding. As aedes is day biter, we should be cautious enough to sanitize our working places along with our domestic environment. Medical Entomology is the important branch of science which deals with study of vectors, its bionomics, sensitivity of vector to insecticides, assessing vector density & identification of impending outbreaks. We need to develop human resource adequately equipped with entomological expertise so as to effectively deal with various vector borne diseases. Prevention & ControlPrevention & control activities mainly focus on regular fever surveillance, clinical management of cases & integrated vector management (IVM) to curtail mosquito breeding & avoid man- mosquito contact. Personal prophylactic methods like using bed nets, mosquito repellant in various forms is important for individual & family protection. In biological control methods larvivorous fishes are introduced in appropriate water bodies. Biocides like Bti are also used. Use of Temephos as a larvicide as well as aerosol space spray using suitable insecticide are the modes of chemical control. IVM emphasizes on environmental management & various source reduction methods. Stored water should be properly covered to avoid mosquito breeding. 'Weekly dry day', concept has been developed as an effective tool of mosquito abatement. Education of masses & community participation in all these activities are keys to success. National Vector Borne Diseases' Control Programme (NVBDCP) deals with prevention & control of all vector borne diseases (VBDs) including Dengue & Chikungunya but without community participation, effective & long lasting control is difficult to achieve. Dengue Vaccine- Ray of HopeThe first dengue vaccine, Dengvaxia by Sanofi Pasteur, was first registered in Mexico in December, 2015. This is a live recombinant tetravalent dengue vaccine that has been evaluated in Phase III clinical studies. As per WHO recommendation, countries should consider introduction of the dengue vaccine only in geographic settings where epidemiological data indicate a high burden of disease. In India, apex committee found limited data to introduce this new vaccine. Experts are expecting more clinical trials & assessment of exact seroprevalence in various geographical areas to safely launch Dengue Vaccine in the country. 'Immune enhancement' is the distinguishing phenomenon found in Dengue pathogenesis. Infection by one of the four dengue virus serotypes has been shown to confer lasting protection against homotypic re-infection, but only transient protection against a secondary heterotypic infection. Secondary heterotypic infection is associated with an increased risk of severe disease. This is called as 'Immune enhancement' which is the major challenge in safe vaccine development for Dengue. Though Dengue vaccine has arrived on the horizon, it should not be looked as panacea for our Dengue menace. There is no substitute to cleanliness and our civic sense of responsibility. We should plan & devise process of urbanization & industrial development conducive to public health. Climate change & global warming is also affecting epidemiology of various diseases including VBDs like Dengue. Consistent rise in temperature is hastening life cycle of aedes & virus maturation, thereby changing disease transmission dynamics. It is high time that we should reduce our absolute dependability on fossil fuels. Strengthening our public transport system is one novel way to reduce our carbon prints & slow down warming of global environment. We also need to develop efficient public health system in our urban localities. Provision of affordable housing is also one aspect of Dengue control. Reasons for rise of Dengue are outside the ambit of public health. Obviously, its solutions need to be sought outside public health. Duane Gubler's observation, "We do not do anything until there is crisis and then we try to react to it & it's always too little, too late," asks all of us to have more comprehensive & timely strategy for Dengue containment and don't forget charity begins from home. By Pradip AwateState Surveillance Officer, Integrated Disease Surveillance Programme, Maharashtra ]]> <![CDATA[India needs better strategies to deal with vector borne diseases]]> https://biospectrumindia.com/features/95/8604/india-needs-better-strategies-to-deal-with-vector-borne-diseases.html https://biospectrumindia.com/features/95/8604/india-needs-better-strategies-to-deal-with-vector-borne-diseases.html Wed, 12 Oct 2016 12:13:39 +0530 With the threat of the deadly, mosquito-borne Zika virus looming large over the country after repeated outbreaks of dengue and chikungunya, India needs a full-fledged national strategy to tackle all mosquito-borne diseases, including malaria. The answer does not lie in the wait for a vaccine against dengue and chikungunya but a national strategy on health and sanitation that will deal effectively, not just with vector-borne diseases but also a host of other disease. On this front, Prime Minister Narendra Modi's Swachh Bharat programme holds considerable promise and should become part of India's National Health Policy. This view was emphatically expressed by the internationally-renowned rheumatologist and expert on the Chikungunya virus (CHIK V), Dr. Arvind Chopra in an exclusive interview to Biospectrum India. Speaking on the current chikungunya and dengue epidemics in parts of the country, Dr. Chopra said that vector-borne diseases should not be looked at in isolation. "We need to eradicate this problem by looking at all infections, and the answer lies in sanitation. The National Malaria Eradication Programme began well but did not achieve its end point and we continue to suffer. We certainly need better research and vaccine development, but above all, we need a cleaner country," Dr. Chopra said. A gold medalist from the Armed Forces Medical College (AFMC) and the University of Pune (M.D./ postgraduate studies), Dr. Chopra is presently Director and Chief Rheumatologist at the Arthritis Research & Care Foundation - Centre for Rheumatic Diseases, Pune. He served at the AFMC and Military Hospital, Belgaum for nearly a decade before serving at prominent hospitals in India and abroad. An International Fellow of the American College of Rheumatology, Dr. Chopra is recipient of numerous national and international awards and fellowships. As the international coordinator for the WHO International league against Rheumatism, he has been leading COPCORD (community oriented program for control of rheumatic diseases) which has completed or is in progress in over 21 countries to measure pain, arthritis and disability in the community. "In India we have covered over one lakh population for several arthritis disorders and were also able to capture the musculoskeletal pain and rheumatism caused by chikungunya during COPCORD surveys in south India," he said. Current Epidemics Both, Dengue and Chikungunya are mosquito-borne viral diseases caused by the Aedes Aegypti and Aedes Albopictus mosquitoes. The dengue virus has four serotypes and two manifestations - dengue haemorrhagic fever (DHF) and dengue shock syndrome (DSS). The Chikungunya fever and severe joint pains are caused by the Chikungunya virus. According to National Vector Borne Disease Control, this year, India has recorded 14,656 cases of chikungunya with Karnataka accounting for 66% of the cases across the country, followed by Maharashtra and Delhi. In Delhi, 30 people have died and nearly 3,000 affected due to vector borne diseases. In a report released on Sept 14, the All India Institute of Medical Sciences (AIMS), said, 70% of people admitted since Sept 1-13 were from UP, 10% from Bihar and the rest from Delhi. The Indian Council of Medical Research (ICMR) has stated that there is a notable upsurge of dengue and chikungunya across the country this year. Prolonged monsoon and unpredictable rains, accumulation of stagnant water and construction activity have been identified as contributing factors. This year, a 25% rise in dengue cases is expected in the country due to heavy monsoons. While municipal corporations have been resorting to fogging operations as a primary strategy to deal with the mosquito menace, what is required, say experts are programmes to attack mosquito larva. The World Health Organization (WHO) has called for better surveillance and reporting of these cases. Considerable pressure was mounting on the hospitals in Delhi from the large number of patients seeking treatment and complaining of delays and poor arrangements. The hospitals in the national capital were also over-stretched with rising numbers of patients. Maharashtra also reported a rise in the incidence of the vector-borne diseases, with 2,500 dengue cases and 14 deaths in the state this year as compared to 1,600 cases and 10 deaths last year. More than 90% of the Chikungunya cases in the state were reported from Pune district alone. According to a report by the state health department, while dengue cases have doubled this year, chikungunya recorded a 13-fold increase in the first nine months of 2016 as compared to the corresponding period last year. Known as the 'disease of the south", since 2010, nearly 1.60 lakh cases of Chikungunya have been reported from the southern states, with the highest number (34%) occurring in Karnataka followed by Bengal (18%) and Maharashtra (12%). Chikunguyna since 1972 The chikungunya epidemic in 2006 in northern and western India and Andhra Pradesh and Karnataka was when Dr. Chopra and his team at the Centre for Rheumatic Diseases, Pune, undertook a detailed examination of the disease. It was 32 years ago that the 1972 epidemic had surfaced in Barshi in Solapur district when the Asian strain of the virus was isolated. "There was a complete dearth of information in the Indian medical community. It was not easy to differentiate this painful disorder from dengue and the common belief was that chikungunya surfaced once in 10 years. In 2006, Dr. Chopra's team detected that the disease was not merely an urban phenomenon as was commonly believed but also rural and had affected large parts of rural Maharashtra, especially in Marathwada. A detailed paper by the rheumatologist on the emerging challenge of chikungunya in the journal Arthritis & Rheumatism, 2008, unravelled a spectrum of musculoskeletal disorders including disabling arthritis, and was found extremely useful by the medical community. A more exhaustive study was undertaken in village Bavi in Solapur district where a large section of the village with a population of 2,000 had been infected with the disease. A paper based on the comprehensive study was published in the prestigious international journal Epidemiology & Infection pointing out that the disease struck like lightning resulting in severe joint pains within a few minutes and that the elderly were worst affected and children were least affected. The Bavi study also demonstrated that anti-CHIK IgM antibodies (in patients with acute infection) persisted for upto 6 months. "In apparently healthy villagers without a history of CHIK V illness, 4-8% also tested positive (IgM or IgG) indicating that a certain load of infection in the community may be subclinical and asymptomatic." The study showed that both IgM and IgG (protective response in patients who had the virus) CHIK V antibodies could be demonstrated within 6 days of onset of illness. This, Dr. Chopra said, "was rather unusual as it is uncommon to detect IgM antibodies within 4 days of illness and IgG antibodies during the acute phase. In 2013, Dr. Chopra and his team published a paper in the American College of Rheumatology's journal, Arthritis & Rheumatism questioning the efficacy of Chloroquine which was administered widely by the medical community for the treatment of chikungunya musculoskeletal pain and arthritis. Based on the analysis of 509 acute CHIK V cases in village Bavi in Solapur district, the exploratory study "failed to identify an advantage of chloroquine over meloxicam to treat early musculoskeletal pain and arthritis following acute CHIK V." At the same time it did not rule out a therapeutic efficacy of chloroquine. Dr. Chopra traced the treatment by chloroquine to a paper published in 1984 in a South African medical journal where the possibility of the efficacy of the drug was explored. He noted that this in itself was not enough to elevate the drug as a surefire treatment for chikungunya and called for more research into this aspect of the disease. A seminal work done by Dr. Chopra and his team was in the area of acute chikungunya and cytokines which play a critical role in cell signalling. "We measured the cytokines and found that there was a cytokine storm in the patients. We were establishing the pattern of cytokines which go up and down and we established that people who go on to have continuous aches and pains are unable to switch off the cytokines. The study, 'Cytokines in Acute Chikungunya' published in the leading medical journal, PLOS ONE in October 2014, established that an intense cytokine milieu was evident in the early and immediate persistent symptomatic phase and in the recovered subjects." Dr. Chopra regretted that India continued "to have a knee jerk reaction to calamities" and described the nation's response from the perspectives of public health and community medicine as deplorable. "Nothing will happen unless we have a clear-cut health policy on all infections. You can't fight chikungunya and ignore malaria. You can't fight chikungunya and ignore dengue. We only need a one-point programme: we need health and sanitation. Why don't we realise it? What the prime minister says is absolutely correct," he said. Pointing out that Sri Lanka had been declared by WHO as free from malaria, he asked why was India unable to do so even after so many decades of the malaria eradication programme? "When I was studying MBBS in 1978 we were learning about the malaria eradication programme, and there was hope. The programme has failed, but why haven't we done a post-mortem? Why are we only crisis-oriented?" he asked. He said that Indian research organisations and medical colleges need to undertake deeper research into Chikungunya during the prevalence of the epidemic as was done by French researchers during the epidemic in Reunion Islands in the Indian Ocean, east of Madagascar. "We Indians need to learn how to probe an epidemic. In Delhi, we have just passed the buck between Kejriwal and the Lietenant Governor," he said angrily while regretting that a golden opportunity had been lost to study the Indian aspect of the epidemic in its depth. Although it is strongly believed that chikungunya is a non fatal disease, Dr. Chopra pointed out that several deaths have been reported from India and elsewhere which could be coincidental or indirectly attributable. "The pity is that we have not carried out any autopsy studies to isolate the virus in brain to clinch the issue. A young lady suffering from chikungunya was alleged to have died of myocarditis in Delhi as per news media but I wonder whether we tried to unearth scientific evidence to support this contention. It is a shame that despite having expertise and advanced technology in labs, our research falls short of delivering meaningful outcomes," he said. Drawing attention to the poor status of research publications on a peer reviewed world platform, he cited the example of China which has a large number of collaborative research papers published in outstanding journals like the New England Journal of Medicine. He also pointed out to the potential dangers of the virus from genetic changes and called for exhaustive research in the Indian context. For example, the Aedes Albopictus which is one of the carriers of CHIK V has the capacity to survive in temperate and cooler climates, taking the virus to Europe and the U.S. Research in animals in France and Australia had shown that CHIK V can kill neonatal mice by infecting the brain. While the virus was known to attack the nervous tissue in mice, this, however, was not the case in humans. At the same time, however, there was the mosquito-borne Zika virus which infected the brain and transmitted the virus to the foetus in pregnant women, Dr. Chopra noted. He pointed out that it was worth noting that the authoritative American website of the CDC (Centers for Disease Control) had categorised chikungunya as a "bioterrorism tool". According to him, an important research question is whether the ongoing chikungunya in India for over 10 years will lead to higher incidence of arthritis and rheumatism and whether the virulence of the virus has increased. "We will need national surveys to address such questions in the near future," he said. What is also needed is an exploration of the nexus between infections like chikungunya and Arthritis and Rheumatism. "All this must form a part of our national health programmes. It is a pity that despite musculoskeletal pains and arthritis being a predominant problem in the community, especially for women and elderly, it has been totally ignored in our national programmes on non-communicable diseases, rural health mission and various women health initiatives, he said. Abhay Vaidya ]]> <![CDATA[Dr Reddy's Lamotrigine orally disintegrating tablets is now available in the US]]> https://biospectrumindia.com/news/95/8599/dr-reddys-lamotrigine-orally-disintegrating-tablets-is-now-available-in-the-us.html https://biospectrumindia.com/news/95/8599/dr-reddys-lamotrigine-orally-disintegrating-tablets-is-now-available-in-the-us.html Wed, 12 Oct 2016 11:09:17 +0530 Dr. Reddy's Laboratories announced that it has launched Lamotrigine Orally Disintegrating Tablets in 25 mg, 50 mg, 100 mg, and 200 mg, a therapeutic equivalent generic version of Lamictal ODT (lamotrigine) Orally Disintegrating Tablets in the United States market approved by the U.S. Food & Drug Administration (USFDA). The Lamictal ODT brand and generic had U.S. sales of approximately $65.5 million MAT for the most recent twelve months ending in July 2016 according to IMS Health. Dr. Reddy's Lamotrigine Orally Disintegrating Tablets 25 mg, 50 mg, 100 mg, and 200 mg are available in bottle count sizes of 30's. Lamictal ODT is a registered trademark of GSK group of companies. ]]> <![CDATA[Bharat Biotech's Zika vaccine to enter phase-I trials]]> https://biospectrumindia.com/news/95/8600/bharat-biotechs-zika-vaccine-to-enter-phase-i-trials.html https://biospectrumindia.com/news/95/8600/bharat-biotechs-zika-vaccine-to-enter-phase-i-trials.html Mon, 10 Oct 2016 13:44:00 +0530 Singapore: Giving a further boost to Modi governemt's Make in India initiative, India's Bharat Biotech recently announced that the company has completed pre-clinical studies on its novel Zika vaccine candidate- Zikavac and is now seeking the approval of the government to begin phase-1 trials. In the proposed phase-1 trials, the vaccine candidate will be tested on around 100 people for safety. "We have completed pre-clinical toxicology studies in animals successfully, and have sought permission from Drug Controller General of India (DCGI)," said D.V.J.A. Harshavardhan, director of viral vaccines and international affairs at Bharat Biotech. The officials also indicated that the government could fast track rthe approval process of the vaccine. Bharat Biotech in February unveiled two of its vaccine candidates to protect humans against the mosquito-borne Zika virus and claimed that it is probably the first in the world to file for a global patent for Zika vaccine candidates. Zikavac, is an inactivated vaccine, or the one that contains a dead virus. The vaccine maker said it's in constant touch with WHO and sharing details about the vaccine's development. The World Health Organization (WHO) had recently declared a global public health emergency because of Zika's apparent link to microcephaly, a birth defect marked by small heads and serious developmental problems in infants. Recently detected in Brazil, Zika is currently wreaking havoc in the Southeast Asian countries. Though India has no known cases of the virus so far, a Lancet study in September said that 2.6 billion people living in parts of Asia and Africa could be at risk of infection, based on a new analysis of travel, climate and mosquito patterns in those regions.The US CDC had recently issued a travel warning stating that pregannat women must avoid travel to 11 countries in Southeast Asia where theZika virus was circulating. The countries cited in the new advisory by the C.D.C. include Brunei, Cambodia, East Timor, Indonesia, Laos, Malaysia, the Maldives, Myanmar, the Philippines, Thailand and Vietnam. ]]> <![CDATA[Zydus signs in-licensing deal with Neovii of Switzerland]]> https://biospectrumindia.com/news/95/8598/zydus-signs-in-licensing-deal-with-neovii-of-switzerland.html https://biospectrumindia.com/news/95/8598/zydus-signs-in-licensing-deal-with-neovii-of-switzerland.html Fri, 07 Oct 2016 11:08:42 +0530 The Ahmedabad headquartered, Zydus group has entered into an in-licensing agreement with Neovii, a Switzerland based global biopharmaceutical company to launch Grafalon ,an immunosuppresant extensively used in solid organ transplants and Stem Cell Transplant, in India. Neovii has been dedicated for over three decades to improve the outcomes in transplantation medicine, hemato-oncological and immune disorders. The Zydus group will market this therapy through Zydus Trans-immune, a division that offers a range of therapies related to transplant medicine. With the inclusion of Grafalon, Zydus Trans-immune becomes a leading player in transplant-immuno therapy segment and will be able to offer the most comprehensive therapy portfolio in solid organ transplant and stem cell transplant. The market for transplant-immuno therapies is estimated at Rs. 483 crore.(Source IPSOS) Organ transplantation is the most preferred option for patients with end-stage organ failure since both survival and quality of life are superior as compared to patients who live without transplantation. However, one of the major challenges in organ transplantation is graft rejection. In most cases, transplant rejection occurs when transplanted tissue is rejected by the recipient's immune system, which destroys the transplanted tissue. Likewise, Stem Cell Transplantation remains key treatment option for those suffering from haematological conditions including malignancies. Transplant outcomes can be improved significantly by the use of immunosuppressant drugs like Grafalon. Grafalon (formerly commercialized as ATG Fresenius) is used as a part of immunosuppressive regimens (induction protocol) for the prevention and treatment of rejection in solid organ transplantation, prevention of graft versus host disease in stem cell transplantation. As an rATG anti-human T-lymphocyte globulin, Grafalon enjoys worldwide recognition among solid organ and stem cell transplant teams and has transformed the way transplant teams manage the care of transplant recipients around the world. ]]> <![CDATA[Daiichi Sankyo moves forward with innovative antimalarial drug research collaboration]]> https://biospectrumindia.com/news/95/8520/daiichi-sankyo-moves-forward-with-innovative-antimalarial-drug-research-collaboration.html https://biospectrumindia.com/news/95/8520/daiichi-sankyo-moves-forward-with-innovative-antimalarial-drug-research-collaboration.html Thu, 06 Oct 2016 11:11:03 +0530 Daiichi Sankyo Company, Limited , announced that it has entered into a new joint research agreement with Medicines for Malaria Venture (hereafter MMV) regarding Lead Optimization Project with the aim of developing a new, innovative antimalarial drug. In June 2013, Daiichi Sankyo and MMV launched a High-Throughput Screening (HTS) project of a 50,000 compounds library from Daiichi Sankyo with the goal of discovering antimalarial hit compounds. Building on the identification of three hit series during the HTS project, Hit-to-Lead project was launched in March 2015. As a result of these previous collaborative research projects, two leads that meet the criteria set by the Global Health Innovative Technology Fund (hereafter GHIT Fund) and MMV have been obtained. The collaborative research will now proceed to the next stage as Lead Optimization Project beginning in October 2016. The project goal for the Daiichi Sankyo and MMV project team is to produce a clinical candidate with suitable antimalarial "drug-like" properties. This collaborative research project is funded through the GHIT Fund's Product Development Platform and will receive approximately 180 million yen over a period of two years. By developing and producing pharmaceutical agents and improving access to healthcare in developing countries, Daiichi Sankyo is actively contributing towards the third Sustainable Development Goal (SDG) set by the United Nations: ensuring healthy lives and promoting well-being for all people at all ages. Daiichi Sankyo is also contributing to the health and quality of life of people across the globe by participating in this collaborative research project into antimalarial drugs. ]]> <![CDATA[Intas buys the generics business of Actavis in the UK & Ireland]]> https://biospectrumindia.com/news/95/8591/intas-buys-the-generics-business-of-actavis-in-the-uk-ireland.html https://biospectrumindia.com/news/95/8591/intas-buys-the-generics-business-of-actavis-in-the-uk-ireland.html Thu, 06 Oct 2016 11:08:51 +0530 Intas Pharmaceuticals Ltd. ("Intas"), through its wholly owned subsidiary Accord Healthcare Ltd. ("Accord"), announced that it has entered into definitive agreements to acquire Actavis UK Ltd. & Actavis Ireland Ltd. ("Actavis UK & Ireland") from Teva Pharmaceutical Industries Ltd. ("Teva") for an enterprise value of approximately £600 million payable in cash. The transaction is part of the European Commission's anti-trust divestiture requirements arising from Teva's acquisition of Actavis Generics. Actavis UK & Ireland is one of the leading suppliers of generic pharmaceuticals in both the UK and Irish markets with selected assets and operations across the respective markets. The company focuses on providing high quality generic products to both pharmacies and wholesalers in the UK & Ireland through its strong employee base of over 600 staff. Actavis UK & Ireland is supported by a strong manufacturing presence in the UK through its Barnstaple site, which provides services both to Actavis UK and Ireland and other third parties. The company generated over £250m of sales in 2015. "This transaction represents a unique opportunity for Intas to build scale in the UK & Ireland - adding to our market leading hospital franchise - and creates a strong platform for further European expansion" says Mr Binish Chudgar, Vice Chairman and Managing Director of Intas. He added, "Through our subsidiary, Accord Healthcare, we have been operating successfully in Europe for more than a decade and this acquisition will make Accord a leading generics player in the UK market. We have a clear plan for the continuation and development of the Barnstaple site and the Actavis UK and Ireland team; we look forward to welcoming them to the Intas Group. We are confident that the cultural alignment between Accord and Actavis UK & Ireland will ensure a smooth integration." "Together we have a great opportunity to build on the strong foundations of our respective organisations; we are excited to join the Intas / Accord family and look forward to an exciting future together" says Sara Vincent, Actavis SVP UK and Ireland. This transaction builds on Accord's commitment to UK manufacturing having recently made a significant investment to reinstate a facility closed by Sanofi Aventis in Newcastle. The Barnstaple plant will become the company's 4th UK site, ensuring Accord has one of the most extensive local supply chains to service pharmacies, hospitals and wholesalers across the UK and Ireland and also into Europe. The transaction is only subject to regulatory approval, which is expected to be provided in the next three months, with completion following shortly thereafter. ]]> <![CDATA[First Dengue Vaccine approved in more than 10 countries]]> https://biospectrumindia.com/news/95/8588/first-dengue-vaccine-approved-in-more-than-10-countries.html https://biospectrumindia.com/news/95/8588/first-dengue-vaccine-approved-in-more-than-10-countries.html Wed, 05 Oct 2016 12:05:57 +0530 Sanofi Pasteur has announced that Dengvaxia dengue vaccine has now received its 11th marketing approval, four of which granted from Regulatory Authorities recognized by the World Health Organization (WHO). To date the vaccine is approved in Mexico, The Philippines, Brazil, El Salvador, Costa Rica, Paraguay, Guatemala, Peru, Indonesia, Thailand and Singapore. The vaccine is also receiving endorsements from key medical societies at national and regional level. Notably, the Latin American Society for Pediatric Infectious Diseases (SLIPE for Sociedad Latino Americana de InfectologÃa PediÃ¡trica) just published its support for dengue vaccination. National medical societies in Indonesia, Brazil and Mexico have recently also recommended vaccination with Dengvaxia. These recommendations are consistent with the World Health Organization position paper issued on July 29th recommending that countries with high burden of disease should consider introduction of Dengvaxia as part of an integrated dengue management program. "We're pleased to see the growing medical and public health recognition for the vaccine," notes Su Peing Ng, MD, Head of Global Medical Affairs for Sanofi Pasteur. "With this new tool in hand, public health communities in dengue-endemic countries now have additional means to achieve the WHO objectives for 50% reduction in mortality and 25% reduction in morbidity due to dengue by 2020." Parana State in Brazil has administered first doses in its public vaccination campaign and the Philippines have just initiated 2nd dose administration to students in public schools in three highly endemic areas of the country. The vaccine is also being launched through private clinics. In the clinical study population 9 years old and older, the dengue vaccine has been documented to prevent two-thirds of dengue cases due to all four serotypes of dengue. The dengue vaccine also prevented 8 of 10 hospitalizations due to dengue and 93% of serious dengue cases like the deadly hemorrhagic form of the disease, over the 25-month study follow-up period of the large-scale efficacy studies conducted in 10 endemic countries in Latin America and Asia. An integrated safety analysis was recently published documenting Dengvaxia's satisfactory safety profile comparable to placebo during the late stage clinical study program involving around 30,000 participants from 15 countries. In addition, the results of this analysis documented that the vaccine provided beneficial protection against hospitalization due to dengue and severe dengue for up to 4 years post dose 1 of vaccination compared to placebo in the study population 9 years and older. ]]> <![CDATA[Yoshinori Ohsumi wins Nobel prize in medicine for work on autophagy]]> https://biospectrumindia.com/news/95/8585/yoshinori-ohsumi-wins-nobel-prize-in-medicine-for-work-on-autophagy.html https://biospectrumindia.com/news/95/8585/yoshinori-ohsumi-wins-nobel-prize-in-medicine-for-work-on-autophagy.html Mon, 03 Oct 2016 16:57:15 +0530 The Nobel Assembly at Karolinska Institutet has decided to award the 2016 Nobel Prize in Physiology or Medicine to Yoshinori Ohsumi for his discoveries of mechanisms for autophagy. This year's Nobel Laureate discovered and elucidated mechanisms underlying autophagy, a fundamental process for degrading and recycling cellular components. The word autophagy originates from the Greek words auto-, meaning "self", and phagein, meaning "to eat". Thus,autophagy denotes "self eating". This concept emerged during the 1960's, when researchers first observed that the cell could destroy its own contents by enclosing it in membranes, forming sack-like vesicles that were transported to a recycling compartment, called the lysosome, for degradation. Difficulties in studying the phenomenon meant that little was known until, in a series of brilliant experiments in the early 1990's, Yoshinori Ohsumi used baker's yeast to identify genes essential for autophagy. He then went on to elucidate the underlying mechanisms for autophagy in yeast and showed that similar sophisticated machinery is used in our cells. Ohsumi's discoveries led to a new paradigm in our understanding of how the cell recycles its content. His discoveries opened the path to understanding the fundamental importance of autophagy in many physiological processes, such as in the adaptation to starvation or response to infection. Mutations in autophagy genes can cause disease, and the autophagic process is involved in several conditions including cancer and neurological disease. Degradation - a central function in all living cellsIn the mid 1950's scientists observed a new specialized cellular compartment, called an organelle, containing enzymes that digest proteins, carbohydrates and lipids. This specialized compartment is referred to as a "lysosome" and functions as a workstation for degradation of cellular constituents. The Belgian scientist Christian de Duve was awarded the Nobel Prize in Physiology or Medicine in 1974 for the discovery of the lysosome. New observations during the 1960's showed that large amounts of cellular content, and even whole organelles, could sometimes be found inside lysosomes. The cell therefore appeared to have a strategy for delivering large cargo to the lysosome. Further biochemical and microscopic analysis revealed a new type of vesicle transporting cellular cargo to the lysosome for degradation. Christian de Duve, the scientist behind the discovery of the lysosome, coined the term autophagy, "self-eating", to describe this process. The new vesicles were named autophagosomes. During the 1970's and 1980's researchers focused on elucidating another system used to degrade proteins, namely the "proteasome". Within this research field Aaron Ciechanover, Avram Hershko and Irwin Rose were awarded the 2004 Nobel Prize in Chemistry for "the discovery of ubiquitin-mediated protein degradation". The proteasome efficiently degrades proteins one-by-one, but this mechanism did not explain how the cell got rid of larger protein complexes and worn-out organelles. Could the process of autophagy be the answer and, if so, what were the mechanisms? A groundbreaking experimentYoshinori Ohsumi had been active in various research areas, but upon starting his own lab in 1988, he focused his efforts on protein degradation in the vacuole, an organelle that corresponds to the lysosome in human cells. Yeast cells are relatively easy to study and consequently they are often used as a model for human cells. They are particularly useful for the identification of genes that are important in complex cellular pathways. But Ohsumi faced a major challenge; yeast cells are small and their inner structures are not easily distinguished under the microscope and thus he was uncertain whether autophagy even existed in this organism. Ohsumi reasoned that if he could disrupt the degradation process in the vacuole while the process of autophagy was active, then autophagosomes should accumulate within the vacuole and become visible under the microscope. He therefore cultured mutated yeast lacking vacuolar degradation enzymes and simultaneously stimulated autophagy by starving the cells. The results were striking! Within hours, the vacuoles were filled with small vesicles that had not been degraded. The vesicles were autophagosomes and Ohsumi's experiment proved that authophagy exists in yeast cells. But even more importantly, he now had a method to identify and characterize key genes involved this process. This was a major break-through and Ohsumi published the results in 1992. Autophagy genes are discoveredOhsumi now took advantage of his engineered yeast strains in which autophagosomes accumulated during starvation. This accumulation should not occur if genes important for autophagy were inactivated. Ohsumi exposed the yeast cells to a chemical that randomly introduced mutations in many genes, and then he induced autophagy. His strategy worked! Within a year of his discovery of autophagy in yeast, Ohsumi had identified the first genes essential for autophagy. In his subsequent series of elegant studies, the proteins encoded by these genes were functionally characterized. The results showed that autophagy is controlled by a cascade of proteins and protein complexes, each regulating a distinct stage of autophagosome initiation and formation. Autophagy - an essential mechanism in our cellsAfter the identification of the machinery for autophagy in yeast, a key question remained. Was there a corresponding mechanism to control this process in other organisms? Soon it became clear that virtually identical mechanisms operate in our own cells. The research tools required to investigate the importance of autophagy in humans were now available. Thanks to Ohsumi and others following in his footsteps, we now know that autophagy controls important physiological functions where cellular components need to be degraded and recycled. Autophagy can rapidly provide fuel for energy and building blocks for renewal of cellular components, and is therefore essential for the cellular response to starvation and other types of stress. After infection, autophagy can eliminate invading intracellular bacteria and viruses. Autophagy contributes to embryo development and cell differentiation. Cells also use autophagy to eliminate damaged proteins and organelles, a quality control mechanism that is critical for counteracting the negative consequences of aging. Disrupted autophagy has been linked to Parkinson's disease, type 2 diabetes and other disorders that appear in the elderly. Mutations in autophagy genes can cause genetic disease. Disturbances in the autophagic machinery have also been linked to cancer. Intense research is now ongoing to develop drugs that can target autophagy in various diseases. Autophagy has been known for over 50 years but its fundamental importance in physiology and medicine was only recognized after Yoshinori Ohsumi's paradigm-shifting research in the 1990's. For his discoveries, he is awarded this year's Nobel Prize in physiology or medicine. ]]> <![CDATA[Sayre Therapeutics announces DaunoXome named patient program]]> https://biospectrumindia.com/news/95/8586/sayre-therapeutics-announces-daunoxome-named-patient-program.html https://biospectrumindia.com/news/95/8586/sayre-therapeutics-announces-daunoxome-named-patient-program.html Mon, 03 Oct 2016 16:13:30 +0530 Sayre Therapeutics today announced the establishment of a Named Patient Program for DaunoXome (liposomal daunorubicin) for India, Sri Lanka, Bangladesh, Nepal and Pakistan, under an exclusive distribution arrangement with Galen Limited. DaunoXome is an anti-cancer medicine (a cytotoxic agent) that belongs to a group of medicines called anthracyclines. A Named Patient Program is a mechanism through which physicians can legally and ethically prescribe drugs which are not yet approved in a specific country, in line with local country regulations. The active substance of DaunoXome is daunorubicin. DaunoXome is a special formulation of daunorubicin (in liposome form), which is used to treat a type of cancer known as Kaposi's sarcoma. Kaposi's sarcoma is a form of cancer that mainly affects the skin, but which can also affect the lungs and intestines. DaunoXome reduces the growth of these tumour cells. DaunoXome is used for the treatment of a severe form of Kaposi's sarcoma in patients with AIDS. David Bennett, Managing Director of Galen Limited, stated, "We are delighted to have established this partnership with Sayre Therapeutics for India and the SAARC countries. This agreement provides an important additional option for clinicians in these countries, who are treating patients with advanced HIV-related Kaposi's sarcoma." ]]> <![CDATA[OPPI reelects its office bearers]]> https://biospectrumindia.com/news/95/8583/oppi-reelects-its-office-bearers.html https://biospectrumindia.com/news/95/8583/oppi-reelects-its-office-bearers.html Fri, 30 Sep 2016 11:47:00 +0530 At the recently held Statutory Annual General Meeting of members of the Organisation of Pharmaceutical Producers of India (OPPI), Dr Shailesh Ayyangar, Managing Director India and VP South Asia, Sanofi was unanimously elected as the President for the year 2016-17. Dr Ayyangar has held this position for the past three years. At the same meeting, four vice-presidents were elected unanimously - Mr Sudarshan Jain (Managing Director - Healthcare Solutions, Abbott Healthcare Pvt Ltd), Mr Sharad Tyagi (Managing Director, Boehringer Ingelheim India Pvt Ltd), Mr K. G. Ananthakrishnan (Vice President & Managing Director, MSD India) and Mr Sanjiv Navangul (Managing Director, Janssen India-Johnson & Johnson Ltd.). The elected office bearers of OPPI will have their tenure till the next Annual General Meeting in 2017. Commenting on his reelection, Dr Shailesh Ayyangar, said, "I would like to thank my fellow colleagues in the Executive Committee for their tremendous support and guidance over the years and for reposing their faith in me to lead OPPI in its 51st year of existence." He congratulated the elected office bearers and reaffirmed OPPI's commitment to work with all stake holders to contribute significantly towards the healthcare agenda of our nation. Kanchana T K, Director General, OPPI said, "On behalf of all our members I welcome our team of office bearers for 2016-17. Under their guidance, OPPI continues to be committed to working with all external stakeholders to ensure that we keep the patient at the centre of all that we do." ]]> <![CDATA[L'OrÃ©al, Poietis to develop bioprinting of hair]]> https://biospectrumindia.com/news/95/8580/loral-poietis-to-develop-bioprinting-of-hair.html https://biospectrumindia.com/news/95/8580/loral-poietis-to-develop-bioprinting-of-hair.html Thu, 29 Sep 2016 15:45:27 +0530 With this exclusive research partnership, L'OrÃ©al and Poietis are giving themselves the means to pursue a new scientific challenge: bioprinting a hair follicle, the small organ that produces hair, using a bioprinter. This research partnership offers exciting perspectives at a time when conventional tissue engineering technologies remain limited in terms of the complexity of cell patterns. The laser-assisted bioprinting technology developed by Poietis to produce biological tissue can position cells in 3D with extremely high cellular resolution (on the order of ten microns) and cellular viability (over 95%). This unique bioprinting technology involves successively layering micro-drops of bioinks using a quick scan by a laser beam. The living biological tissue created must then be matured for around 3 weeks before it can be used in tests. The combination of this exclusive technology with L'OrÃ©al's unique expertise in hair biology could make it possible to create a functional follicle capable of producing hair - that is the ambition of L'OrÃ©al and Poietis. "We're very proud to be working with L'OrÃ©al. The fact that a world-renowned company is adopting our technology is a major step for Poietis," says Fabien Guillemot, CEO and Chief Scientific Officer at Poietis. "Our partnership with L'OrÃ©al should lead to the development of innovative applications in terms of tissue engineering," adds Bruno Brisson, General Manager and Chief Business Officer. "For L'OrÃ©al, the combination of our respective areas of expertise opens up the possibility of previously unheard of achievements in the field of hair. This research partnership is very stimulating for the Advanced Research teams," explains JosÃ© Cotovio, Director of Predictive Methods and Models department, L'OrÃ©al Recherche & Innovation. Poietis and L'OrÃ©al's multi-annual research partnership in the areas of hair biology and hair engineering should ultimately lead to new advances in hair knowledge and enable the development of exclusive efficacy testing on bioprinted hair samples. ]]> <![CDATA[Piramal plans to expand its API development & manufacturing capabilities at Digwal plant]]> https://biospectrumindia.com/news/95/8573/piramal-plans-to-expand-its-api-development-manufacturing-capabilities-at-digwal-plant.html https://biospectrumindia.com/news/95/8573/piramal-plans-to-expand-its-api-development-manufacturing-capabilities-at-digwal-plant.html Wed, 28 Sep 2016 15:15:55 +0530 Piramal Pharma Solutions, a leading global contract manufacturer with presence across North America, Europe and India plans to expand its API development and manufacturing capabilities in Digwal, India. Located close to Hyderabad, India, Digwal is Piramal's USFDA approved flagship, late phase development and commercial API facility, that serves both large pharmaceutical clients and biotechs, world-wide. This expansion will expand both, the pilot plant and commercial footprint. The new pilot facility will have 12 reactors compliant with US FDA standards for late stage validation batches, and the commercial facility will have 8 vessels that to be used for batch sizes between 100 kilos and 1000 kilos. The new plant will be equipped with cryogenic reaction capabilities and will also feature significant automation. Containment and engineering controls will allow for safe manufacture of up to Safebridge Category 3 API's. The facility places an emphasis on EHS&S controls and will incorporate a modular design, that allows for future expansions. "Over the past several years we have seen a significant increase in demand for API and drug product needs from our clients, and to address these requirements, we are working towards appropriate solutions", said Vivek Sharma, CEO of Piramal Pharma Solutions. "Digwal is our largest API site, and we want to ensure that we have the scale to meet our customers future needs. This expansion is a testament to the trust our customers have placed in us." "As we looked at our late stage API development pipeline from a portfolio level, we quickly realized that this expansion was necessary to meet the upcoming commercial demands of our customers", said Dr. Mark Cassidy, President of the API Business at Piramal Pharma Solutions. "We listened to our clients and their needs as we designed this facility: batch size flexibility, versatile vessel trains that can be used for a range of chemistries, containment and engineering controls for handling potent compounds, all address our current pipeline and the future needs that our clients expect to have. It has been a privilege to partner with our clients and develop potential solutions that target some of the most debilitating diseases of this generation." ]]> <![CDATA[Bayer inaugurates global Formulation Technology Lab at Vapi]]> https://biospectrumindia.com/news/95/8578/bayer-inaugurates-global-formulation-technology-lab-at-vapi.html https://biospectrumindia.com/news/95/8578/bayer-inaugurates-global-formulation-technology-lab-at-vapi.html Wed, 28 Sep 2016 12:15:34 +0530 Bayer inaugurated a new Global Formulation Technology Laboratory at its site in Vapi, Gujarat. The plant in Vapi is a production site for active ingredients for the crop science division of Bayer globally, with expertise in Analytics and Formulation development. In India the demand for high quality food is growing rapidly with its fast growing population and rising incomes. "With our innovative crop protection products, we are contributing to finding solutions to some of the major challenges of our time including feeding a fast growing world population ." said Dr. Bernhard Grimmig, Global Head of Formulation Technology at Crop Science, a division of Bayer. "Bayer is aiming at providing high yielding seeds, efficacious and safe crop protection solutions and services for farmers worldwide to secure their harvests and incomes." "Bayer has a long presence in India with the development and production of crop protection chemicals as well as the provision of seeds for vegetables and arable crops. The transformation and importance of Indian Agriculture in the last decades has been a critical factor in determining Bayer's long term investments in the country in order to meet the growing demand for improved seeds, professional pest management products and integrated crop management solutions for major agricultural crops. In the last few years, Bayer has been making strategic investments in various research & development, production, and infrastructure projects in India", said Richard van der Merwe, Senior Bayer Representative, South Asia. Bayer has invested more than EUR 2 million for this laboratory. With this new facility, the company aims to increase resource flexibility in its global formulation activities, helping to increase its capacities for innovations around formulation and delivery technologies. The new formulation lab unit will focus on developing seed treatments, herbicides, fungicides, and insecticides for the local demand of smallholder farmers, and also for regional and global demand. "This is a special achievement as this is the first Crop Science formulation development facility in this region and demonstrates the importance of the region for our future business", added Grimmig. K R Sekhar, Managing Director, Bayer Vapi Private Ltd. added, "The Laboratory is the culmination of fantastic team work across different functions within Bayer. It is a collaborative effort to provide customers with the best possible, world-class solutions in agrochemicals." Bayer Vapi is a core manufacturing site for Bayer globally. It employs close to 1300 people. The site has invested heavily in upgrading its safety and environment aspects in order to make it comparable with world standards. It aims at high powered research and development, along with the manufacture of eco-friendly, innovative and internationally competitive agrochemicals. The site is engaged in the manufacturing of active ingredients for use in a wide array of products for modern sustainable agriculture, professional pest management and animal health. ]]> <![CDATA[Pfizer quashes break-up plans, to remain as one entity]]> https://biospectrumindia.com/news/95/8577/pfizer-quashes-break-up-plans-to-remain-as-one-entity.html https://biospectrumindia.com/news/95/8577/pfizer-quashes-break-up-plans-to-remain-as-one-entity.html Wed, 28 Sep 2016 11:58:24 +0530 Pfizer Inc. announced that, after an extensive evaluation, the company's Board of Directors and Executive Leadership Team have determined the company is best positioned to maximize future shareholder value creation in its current structure and will not pursue splitting Pfizer Innovative Health and Pfizer Essential Health into two, separate publicly traded companies at this time. "With this decision, our two distinct businesses will remain separately managed units within Pfizer, which we believe is currently the best structure to continue to deliver on our commitments to patients, physicians, payers and governments, and to drive value for our shareholders," stated Ian Read, chairman and chief executive officer. "We believe that by operating two separate and autonomous units within Pfizer we are already accessing many of the potential benefits of a split - sharper focus, increased accountability, and a greater sense of urgency - while also retaining the operational strength, efficiency and financial flexibility of operating as a single company as compared with operating as two, separate publicly traded companies. We will continue to generate the financial information necessary to preserve our option to split our businesses should factors materially change at some point in the future." As the company previously indicated, the process for making a decision was guided by criteria that included evaluating the performance of each business within Pfizer, determining if each business could compete as a stand-alone entity, assessing if trapped value existed in a combined entity and if any trapped value could be unlocked efficiently. In addition, the company evaluated whether key strategic and operating imperatives could best be achieved in the current structure versus two, separate publicly traded companies. "When we first explored the trapped value question several years ago, market valuations of other companies suggested that our two businesses could potentially be worth more as separate companies than they are together in a single company," explained Frank D'Amelio, executive vice president, Business Operations and Chief Financial Officer. "However, over time, any potential gap between Pfizer's market valuation and an implied Sum of the Parts (SOTP) market valuation has closed. In our analysis, we concluded that splitting into two companies at this time would not enhance the cashflow generation and competitive positioning of the businesses and the operational disruption, increased costs of a split and inability to realize any incremental tax efficiencies would likely be value destructive." Pfizer believes it is poised to grow its Innovative Health and Essential Health businesses, so that they can be leaders in their markets. Over the past several years, the company rebuilt its pipeline and transformed its approach to R&D. Pfizer also created a dedicated R&D capability for its Essential Health business and formed the Global Product Development Group, which is a unified center for late-stage development to maximize the value of its R&D investments. Since 2010, Pfizer received 20 new drug approvals and launched multiple products to address patients unmet medical needs, including Ibrance, Xalkori, Bosulif, Inlyta, Eliquis, Prevnar Adult and Trumenba. In addition, the company has established an industry leading portfolio of sterile injectables, biosimilars and effective, high-value treatments that have lost their market exclusivity. Pfizer Innovative Health is growing with incremental revenues from the company's most recently launched products and is further strengthened by the acquisition of Anacor and the pending acquisition of Medivation. Pfizer believes that its Essential Health business is positioned to return to sustainable growth over the next few years driven by the sterile injectables and biosimilars businesses, and anticipated continued growth in emerging markets. The business was further bolstered with the acquisition of Hospira and Innopharma, and the pending acquisition of AstraZeneca's small molecule anti-infectives business. Over the same period, Pfizer captured approximately $32 billion from the disposition of its Capsugel and Nutrition businesses, and the IPO and share exchange associated with the spinoff of its Animal Health business, and has returned $88.1 billion to shareholders through dividends and share repurchases since 2010. The company remains committed to creating value for its shareholders, and will continually evaluate the composition of its portfolio to determine the optimal mix of businesses for maximizing that value. To further outline the financial performance of its two businesses, the Company will begin to more fully allocate indirect expenses for each of its two businesses by including estimates of the dollar value of such expenses, where appropriate. This will commence with the publicly-disclosed quarterly financials for the first-quarter 2017. Pfizer will move forward with a focus on its strategic priorities to grow and increase operational efficiency to be more competitive. ]]> <![CDATA[Takeda, Zydus partner to develop Chikungunya vaccine]]> https://biospectrumindia.com/news/95/8567/takeda-zydus-partner-to-develop-chikungunya-vaccine.html https://biospectrumindia.com/news/95/8567/takeda-zydus-partner-to-develop-chikungunya-vaccine.html Mon, 26 Sep 2016 11:43:26 +0530 Takeda Pharmaceutical Company and Zydus Cadila announced a partnership to tackle chikungunya, an emerging infectious disease in Africa, Asia and the Indian subcontinent. In recent decades mosquito vectors of chikungunya have spread to Europe and the Americas. According to the Centers for Disease Control and Prevention (CDC) in the USA, there is currently no vaccine to prevent or medicine to treat chikungunya virus infectionii. The chikungunya virus is most often spread to people by Aedes aegypti and Aedes albopictus mosquitoes, the same vectors that spread dengue and Zika. Terms are not disclosed but the partnership agreement covers early stage development through the final commercialization of the vaccine. Dr. Rahul Singhvi, Takeda Vaccines' Chief Operating Officer said: "Takeda is very pleased to work with Zydus Cadila. We are tackling the world's most urgent and neglected unmet medical needs together with our partners. Our belief is that chikungunya can be prevented with a vaccine, and that we can accelerate development through this Zydus partnership." Speaking about this key development, Mr. Pankaj R. Patel, Chairman and Managing Director, Zydus group said, "We have always been committed to working with partners and collaborating to bring affordable therapies and bridge unmet healthcare needs. By working with Takeda on this very important research and development initiative and leveraging our development capabilities, we will be taking an all important step to prevent the disease burden which is highly prevalent in developing countries and causes suffering and disability." Takeda's Dr. Singhvi added: "Takeda is at the center of important vaccine-related activities in global health and emerging infectious diseases. This is another demonstration of Takeda's major commitment to the health of people everywhere." ]]> <![CDATA[Emma Walmsley is GSK's new CEO]]> https://biospectrumindia.com/news/95/8568/emma-walmsley-is-gsks-new-ceo.html https://biospectrumindia.com/news/95/8568/emma-walmsley-is-gsks-new-ceo.html Mon, 26 Sep 2016 11:43:10 +0530 GSK announces that Emma Walmsley, currently Chief Executive Officer (CEO) of GSK's Consumer Healthcare division, is appointed GSK CEO Designate and will succeed Andrew Witty as GSK CEO, when he retires on 31March 2017. Emma will join the GSK Board of Directors from 1 January 2017. Emma is currently CEO of GSK Consumer Healthcare, one of the world's largest consumer health companies, established in 2015 following completion of GSK's three-part transaction with Novartis. Prior to this, Emma was President of GSK Consumer Healthcare and has been a member of GSK's Corporate Executive Team since 2011. Emma joined GSK in 2010 from L'Oreal where, over the course of her 17-year career, she held a variety of marketing and general management roles in the UK, Europe and USA. From 2007 she was based in Shanghai as General Manager, Consumer Products for L'Oreal China. Philip Hampton, GSK Chairman, said: "I am very pleased to announce Emma's appointment, after what has been a very thorough and rigorous global selection process carried out by the GSK Board of Directors. Emma is an outstanding leader with highly valuable experience of building and running major global businesses and a strong track record of delivering growth and driving performance in healthcare. Under Andrew's leadership, GSK has successfully developed into a company with market-leading positions in pharmaceuticals, vaccines and consumer healthcare. These provide excellent platforms for sustainable, long-term growth, and we are confident Emma will successfully build on these strengths." Emma Walmsley said: "I am delighted and honoured to be appointed GSK's next CEO. GSK is a company that leads both in science and in the way it does business. We have momentum in the Group and as the demand for medical innovation and trusted healthcare products continues to rise, we have the opportunity and the potential to create meaningful benefits for patients, consumers and our shareholders. I'm looking forward to working with Andrew and other leaders over the next few months to ensure a smooth handover and to develop plans for 2017 and beyond." ]]> <![CDATA[Allergan on acquisition spree, buys another NASH firm]]> https://biospectrumindia.com/news/95/8565/allergan-on-acquisition-spree-buys-another-nash-firm.html https://biospectrumindia.com/news/95/8565/allergan-on-acquisition-spree-buys-another-nash-firm.html Fri, 23 Sep 2016 11:25:48 +0530 Allergan plc and Tobira Therapeutics, Inc. a clinical-stage biopharmaceutical company focused on developing and commercializing therapies for non-alcoholic steatohepatitis (NASH) and other liver diseases, has announced that they have entered into a definitive agreement under which Allergan will acquire Tobira for an upfront payment of $28.35 per share, in cash, and up to $49.84 per share in Contingent Value Rights (CVRs) that may be payable based on the successful completion of certain development, regulatory and commercial milestones, for a total potential consideration of up to $1.695 billion. The Boards of Directors of both companies have unanimously approved the transaction. The acquisition adds Cenicriviroc (CVC) and Evogliptin, two differentiated, complementary development programs for the treatment of the multi-factorial elements of NASH, including inflammation, metabolic syndromes and fibrosis, to Allergan's global Gastroenterology R&D pipeline. "The acquisition of Tobira is a strategic R&D investment within a white space area of our global Gastroenterology franchise and an opportunity to advance the development of novel treatments for NASH," said Brent Saunders, CEO and President of Allergan. "With the increasing rates of diabetes, obesity and other metabolic conditions in the U.S. and in developed nations globally, NASH is set to become one of the next epidemic-level chronic diseases we face as a society. It is important that we invest in new treatments today so that healthcare systems, providers and patients have treatment options to face this challenge in the coming years." "With this acquisition, Allergan will now have one of the strongest portfolios of development stage programs for the treatment of NASH, with Cenicriviroc as the cornerstone. We will continue to look for differentiated development-stage assets that can bolster this position and enhance our commitment to innovation in this disease," added Saunders. Cenicriviroc (CVC) is a first-in-class, once-daily, oral Phase 3 ready potent immunomodulator that blocks two chemokine receptors, CCR2 and CCR5, which are involved in the inflammatory and fibrogenic pathways in NASH that cause liver damage and often lead to cirrhosis, liver cancer or liver failure. In the Phase 2b CENTAUR study, CVC demonstrated a clinically and statistically significant improvement in fibrosis of at least one stage without worsening of NASH, one of two key secondary endpoints, after one year of treatment. The acquisition also adds Evogliptin, an oral DPP-4 (Dipeptidyl peptidase-4) inhibitor for the potential treatment of NASH. Evogliptin is being studied in a Phase 1 trial assessing the safety, tolerability and steady-state pharmacokinetic parameters of the compound when administered with and without CVC. In NASH, increased DPP-4 serum levels and hepatic DPP-4 expression is correlated with disease severity. "Both the CVC and Evogliptin programs provide highly differentiated compounds that can make a significant impact in the treatment of NASH, where today there are no approved therapies available for patients," said David Nicholson, Chief Research & Development Officer, Allergan. "Importantly, NASH treatment may well require a multi-therapeutic approach to address the multiple factors of the disease. CVC has been shown in clinical trials to provide significant improvement in liver fibrosis, the hallmark of NASH. Liver fibrosis is associated with key long-term outcomes, including overall mortality, liver transplantation and liver-related events. Evogliptin, in preclinical models, has been shown to decrease hepatic glucose production, improve hepatic triglyceride content and steatosis, and reduce histologic markers of inflammation of the liver. Together, these programs provide a highly complementary potential therapeutic approach to address the inflammatory, metabolic and fibrotic elements of NASH that the medical community will need to treat this condition." "I am extremely excited to see Tobira and Allergan come together," said Laurent Fischer, M.D., Chief Executive Officer, Tobira Therapeutics. "The combination of our team's innovation in the NASH space and the infrastructure, development expertise and world-class ability of Allergan to market medicines will enable us to more rapidly develop and commercialize needed medications for patients suffering from NASH and other serious fibrotic diseases around the world." "We are delighted that cenicriviroc will be rapidly advancing into Phase 3 studies under the stewardship of Allergan, an industry leader with world class capabilities in advancing novel treatment options to patients across the globe, and I look forward to the future success of this partnership," added Dennis Podlesak, Chairman of the Board of Tobira. Covington & Burling LLP is serving as Allergan's lead legal counsel. Centerview Partners and Citi are serving as financial advisors to Tobira and Skadden, Arps, Slate, Meagher & Flom LLP and Gunderson Dettmer Stough Villeneuve Franklin & Hachigian, LLP are serving as Tobira's legal counsel. ]]> <![CDATA[Biotech Innovation Ecosystem - Strategizing the next leap]]> https://biospectrumindia.com/news/95/8563/biotech-innovation-ecosystem-strategizing-the-next-leap.html https://biospectrumindia.com/news/95/8563/biotech-innovation-ecosystem-strategizing-the-next-leap.html Fri, 23 Sep 2016 10:11:51 +0530 The Biotechnology Industry Research Assistance Council (BIRAC), a Public Sector Undertaking under the aegis of the Department of Biotechnology (DBT), Ministry of Science & Technology, Govt. of India organized its 5th Innovators Meet at the Mapple Emerald, New Delhi. The two-day event which is a part of BIRAC's continuous efforts to foster innovation and entrepreneurship started on September 22, 2016 (Thursday) and continues till September 23, 2016 (Friday). The theme of discussion at the meet is 'Biotech Innovation Ecosystem - Strategizing the Next Leap'. The event was attended by Chief Guest Hon'ble Union Minister for Science & Technology and Earth Sciences, Dr. Harsh Vardhan and Guest of Honour, Hon'ble Minister of State (MoS), Science & Technology and Earth Sciences, Shri YS Chowdary. There were over 350 participants including Mr. Yigal Erlich, The Yozma Group and Dr. Sarvajna Dwivedi, Global TiE from Silicon Valley and many other Senior Policy Makers, Industrialists, Startups and Entrepreneurs. Day 1 of the meet started with an open session between high-level investors and innovators. An Innovation Market place featuring 25 innovators was held followed by the Inaugural session. Inaugurating the two day Meet the Chief Guest - Dr. Harsh Vardhan, Hon'ble Union Minister for Science & Technology and Earth Sciences, said "India is the land of innovations and it gives me great pleasure to see such a large number of entrepreneurs and innovators showcasing their ideas. As per the vision of the Prime Minister, this government is doing everything within its power to give Indian entrepreneurs a platform to take their ideas to the world and vie with the best. The BIRAC Innovators Meet is one such platform which brings entrepreneurs and investors together and catalyzes an open discussion between them." The Guest of Honour- Shri YS Chowdary, Hon'ble MoS, Science & Technology and Earth Sciences in his address said "Over the last 5 years, a foundation has been laid for an innovation driven biotech enterprise in the country. DBT's National Biotech Development Strategy for 2015-2020 has defined the policy outline to achieve the next transition for the Indian biotechnology. The Government is keen on making India the pioneer of innovation. We have jumped 15 places in the Innovation Index and we are now on the way to continued growth in the innovation sphere. It is important that the excellent work done by BIRAC in creating the Ecosystem is scaled up. It is important to work with all stakeholders especially states. I am confident that we can scale up this model to spread across the country." Prof. VijayRaghavan, Secretary, DBT and Chairman, BIRAC during the Inauguration said "The biotech startup landscape has grown in the country over theprevious five years. The changing ecosystem has been drivenby several elements such as public funding agencies, angel funding and VC funding. We are more focused on research and innovation than ever before and it is yielding results. Our job is to be present at every stage of the innovation ecosystem so that we are in a position to support innovators by helping take their idea and proof-of-concept to the market. Institutions such as BIRAC are committed to promoting affordable innovation in key social sectors in order to achieve the larger goal and mission of an innovation-driven Indian Biotech Enterprise," Tracing the Journey of BIRAC over the last 5 years, Dr. Renu Swarup, Senior Advisor, Department of Biotechnology and Managing Director, BIRAC in her welcome address said that "BIRAC has been a major catalyst for the growth of the Biotech Innovation Ecosystem in the country. We are today ready to take the next leap. Today with over 500 Start ups and SME's, 100 Entrepreneurs being a part of this ecosystem, we have nearly 50 products in different stages of development and commercialization. Our target is scaling this 10 times in the next 5 years. We are confident that with the enthusiasm we see in the community we can do this". Thy Keynote talk was delivered by Mr. Yigal Erlich, Founder, Chairman and Managing Partner, Yozma Group, Israel, Mr. Erlich, who is the founding father of the Israeli venture capital industry and one of the most prominent figures in the Israeli high-tech arena interacted with the investors and other participants. "The world changed after India gave it the zero (0). India is known for its contribution to invention and innovation. There is a lot that Israel and India can learn from each other. After overseeing an entrepreneurial and innovation revolution in Israel, I am glad to be able to share our learnings and interact with budding entrepreneurs and innovators of India. India is poised to become a major biotechnology hub in the world and sustained support is crucial," said Mr. Yigal Erlich, Founder Yozma Group. Later in the evening, a panel comprising, Prof. VijayRaghavan, Secretary, DBT; Prof. Ashutosh Sharma, Secretary, Department of Science and Technology; Mr. Erlich; and others deliberated on the emerging landscape of private venture funding in the country, especially in the life sciences arena. The Innovators meet continues on September 23, Friday with a plenary talk by Dr. Sarvajna Dwivedi, Global TiE Silicon Valley and a panel discussion on 'Boosting Technology Development & Translation from Academia" scheduled for the day. ]]> <![CDATA[Alzheimer's - A continuing search for treatment and cure]]> https://biospectrumindia.com/news/95/8561/alzheimers-a-continuing-search-for-treatment-and-cure.html https://biospectrumindia.com/news/95/8561/alzheimers-a-continuing-search-for-treatment-and-cure.html Thu, 22 Sep 2016 13:56:11 +0530 September 21, 2016 is commemorated as World Alzheimer's Day. According to Alzheimer 's disease International, there are an estimated 46 million people worldwide affected with dementia of which an estimated 4 million are said to be in India. Of all the known forms of dementia, Alzheimer's is the most common type. And yet despite its growing incidence, there is no cure for Alzheimer's disease and treatment therapies available have little or no effect in stopping or reversing memory loss. "There are significant social and economic costs associated with Alzheimer's and with a global ageing population, it is imperative for us to scale-up research to tackle this growing disease burden," said Suneela Thatte, President of ISCR. "While our understanding of Alzheimer's has improved over the years with advancements being made in studying the disease, we still have a long way to go before we can offer much promise and hope to patients." According to Alzheimer's Research UK, dementia research is hugely underfunded, especially when compared to other major diseases. They say it receives almost ten times less funding than cancer research, for example. "One of the biggest challenges with dementia and Alzheimer's is the social stigma attached to it. People either accept it as a normal part of aging or are reluctant to talk about it," says Dr Shamsher Dwivedi, Head & Director, Department of Neurology, Fortis Memorial Research Institute, Gurgaon. "We need more people to speak up about dementia as much as we need to build the capacity of the entire ecosystem to handle the growing burden of dementia. Research in this area needs to be accelerated." "Aside from obviously increasing the number of clinical trials for Alzheimer's in India, we also need to make them more accessible to patients," said Suneela Thatte. "There are several benefits of signing up for trials so we must make research in Alzheimer's a priority for the millions of patients waiting for better treatment options and possibly even a cure," she added. ]]> <![CDATA[Jubilant Biosys strengthens its leadership team ]]> https://biospectrumindia.com/news/95/8558/jubilant-biosys-strengthens-its-leadership-team-.html https://biospectrumindia.com/news/95/8558/jubilant-biosys-strengthens-its-leadership-team-.html Thu, 22 Sep 2016 13:55:24 +0530 Jubilant Biosys has announced two new leadership appointments. Mr. Steven Hutchins has been appointed as President and Dr. Takeshi Yura has been appointed as Vice President of Medicinal Chemistry. Mr. Steven Hutchins brings 26 years of pharmaceutical & healthcare experience and leadership to Jubilant, including experience in Business Development, R&D as well as strategic partnerships. He has held senior management positions at Merck, BioDuro, WuXi AppTec, and Evotec where he was instrumental in leading the development of strategy, sales & marketing and commercialization of key strategic alliances. "I am honored to assume the role of President of the Jubilant Drug Discovery Solutions family, which includes Jubilant Biosys, Jubilant Chemsys and Jubilant Discovery Services. Throughout my career, I have seen the power of collaboration in drug discovery from the view of a bench scientist as well as a business leader and can unequivocally state that it is the intersection of differing views and strategies that create true innovation. I look forward to working with our team, our clients and our research partners to bring both scientific and commercial success to each program." said Mr. Steven Hutchins, President, Jubilant Biosys. Dr. Takeshi Yura has 28 years of experience in medicinal and organic chemistry. He had held various scientific positions at Tanabe Saiyaku, Bayer Yakuhin, Pfizer Nagoya Laboratories and Dishman Japan Ltd. Before joining Jubilant, he held a senior leadership position at AMRI as Vice President of Discovery and Development Services for Asia and General Manager for Singapore Research center. Dr. Takeshi Yura, Vice President (Medicinal Chemistry), Jubilant Biosys said "I am delighted to join Jubilant Biosys, a leading company providing drug discovery services. The capabilities of Jubilant Biosys are truly impressive and I look forward to contributing to further growth of the company by providing excellent services to our customers worldwide". With these two key leadership appointments Jubilant intends to further expand its global reach, explore new business opportunities and strengthen its position as a leading collaborative partner for Drug Discovery Solutions and its proprietary innovation programs portfolio for out licensing. ]]> <![CDATA["I am a great believer in India's destiny, I am often called a dangerous optimist"]]> https://biospectrumindia.com/news/95/8560/i-am-a-great-believer-in-indias-destiny-i-am-often-called-a-dangerous-optimist.html https://biospectrumindia.com/news/95/8560/i-am-a-great-believer-in-indias-destiny-i-am-often-called-a-dangerous-optimist.html Wed, 21 Sep 2016 18:05:00 +0530 I personally believe the moment of India has arrived. Every Indian has to have that confidence to say that yes, I can, despite adversity and challenges, we will overcome them. There are few things that one has to remember, first is India's destiny is very clear, it's going to be the top nation. How do I contribute to making that happen? each and every endeavour of us is a challenge and for that we need to develop a mindset which is positive, which is constructive which always becomes a part of the solution and not the problem, coupled with a mind which is able to traverse the boundaries of impossible and make it possible, and that can happen if we always remember that the limits to imagination, limits to achievement are something that any Indian mind can overcome provided it does not itself set a limit in terms of what it can aspire to do. I am a great believer in India's destiny, am often called a dangerous optimist. My dangerous optimism comes very frankly from the fact that it is the Indian talent which is finally going to win the war, win a position that is special for us. In every single endeavour, whether it has to do with education, health, industry innovation we can be among the top. I personally have believed in all my life and I believe it now even more so now looking at the leadership that we have, looking at the great smell that I see in India, where everybody is wanting to say my India and move forward. ]]> <![CDATA[Pharma Cos present Industry Roadmap to Combat Antimicrobial Resistance ]]> https://biospectrumindia.com/news/95/8556/pharma-cos-present-industry-roadmap-to-combat-antimicrobial-resistance-.html https://biospectrumindia.com/news/95/8556/pharma-cos-present-industry-roadmap-to-combat-antimicrobial-resistance-.html Wed, 21 Sep 2016 11:15:01 +0530 Ahead of the United Nations General Assembly (UNGA) High-Level Meeting on Antimicrobial Resistance (AMR), 13 leading pharmaceutical companies today presented a new roadmap that lays out four key commitments they will deliver by 2020 to reduce AMR. The commitments follow the principles identified and agreed upon in the Industry Declaration made at the 2016 World Economic Forum in Davos earlier this year, and reflect the companies' intent to continue to proactively contribute to the global efforts to address AMR. This unprecedented collaboration between the pharmaceutical companies marks a major milestone in the fight against AMR. In presenting this roadmap, the signatory companies firmly demonstrate their shared ambition to overcome the staggering threat AMR represents for our society, economies, and citizens. We are committed to working to reduce the development of antimicrobial resistance, improve access to high-quality antibiotics, vaccines, and diagnostics, invest in R&D, and collaborate with governments and stakeholders to sustain those investments. Specifically, this group of diversified companies commit to:1. Reduce the environmental impact from the production of antibiotics, including a review of the companies' manufacturing and supply chains, and work with stakeholders to establish a common framework for assessing and managing antibiotic discharge; 2. Help ensure antibiotics are used only by patients who need them, recognizing this requires concerted efforts from many stakeholders, through continued provider and patient education, an examination of the companies' promotional activities, sharing of surveillance data with public health bodies and healthcare professionals, and collaboration with stakeholders to reduce uncontrolled antibiotic purchase; 3. Improve access to current and future antibiotics, vaccines, and diagnostics, including working with stakeholders to strengthen global health systems and address access bottlenecks; establishing new business models that balance access needs, appropriate antibiotic use, expanded vaccine coverage and adequate return to companies; and working to reduce the prevalence of substandard/counterfeit antibiotics in high-risk markets; and 4. Explore new opportunities for open collaborations between industry and the public sector to address challenges in the research and development of new antibiotics, vaccines, and diagnostics, recognizing the value these bring to society. The companies also reiterate our support for a comprehensive multi-sectoral approach to address the other factors contributing to AMR as defined by the World Health Organization Global Action Plan, the AMR Review, the US National Strategy and Action Plan, and the just released United Nations AMR High Level Meeting declaration. Progress will not be achieved without concerted efforts from all stakeholders, and we call on governments to support the reduction of inappropriate antibiotic use in humans and animals, the improvement of surveillance and infection control measures, the ongoing research and development into novel antibiotics through financial and regulatory incentives, and finally, to deepen commitments to develop and adopt advanced diagnostics to address over-prescription in patients. The companies support the establishment of a high-level coordinating mechanism to provide global leadership, mobilize resources, set goals, and measure progress towards them. We also welcome similar commitments from other stakeholders involved in combating AMR. SIGNATORY COMPANIESAllergan AstraZeneca Cipla DSM Sinochem Pharmaceuticals F. Hoffman-La Roche Ltd., SwitzerlandGSK Johnson & Johnson Merck & Co., Inc., NovartisPfizer Sanofi Shionogi & Co., Ltd. Wockhardt ]]> <![CDATA[Dr Reddy's launches Paricalcitol Injection in the US]]> https://biospectrumindia.com/news/95/8555/dr-reddys-launches-paricalcitol-injection-in-the-us.html https://biospectrumindia.com/news/95/8555/dr-reddys-launches-paricalcitol-injection-in-the-us.html Wed, 21 Sep 2016 11:14:49 +0530 Dr. Reddy's Laboratoriesannounced that it has launched Paricalcitol Injection, USP, in 2 mcg, 5 mcg, 10 mcg, a therapeutic equivalent generic version of Zemplar (paricalcitol) Injection in the United States market approved by the US Food & Drug Administration (USFDA). The Zemplar brand and generic had US sales of approximately $22.5 million MAT for the most recent twelve months ending in July 2016 according to IMS Health. Dr. Reddy's Paricalcitol Injection is available in 2 mcg, 5 mcg, and 10 mcg, and is the first ANDA product launched in the US market. Zemplar is a registered trademark of ABBVIE Inc. ]]> <![CDATA[Allergan Acquires Akarna Therapeutics]]> https://biospectrumindia.com/news/95/8553/allergan-acquires-akarna-therapeutics.html https://biospectrumindia.com/news/95/8553/allergan-acquires-akarna-therapeutics.html Wed, 21 Sep 2016 11:14:16 +0530 Allergan plc has announced that the Company has acquired Akarna Therapeutics Ltd., a privately held biopharmaceutical company focused on developing novel small molecule therapeutics that target inflammatory and fibrotic diseases, for an up-front payment of $50 million, subject to certain adjustments, as well as potential clinical, regulatory and commercial milestone payments related to its lead development compound, AKN-083. In addition to AKN-083, the acquisition also includes a portfolio of additional development-stage FXR compounds. Non-Alcoholic Steatohepatitis (NASH) is a severe type of non-alcoholic fatty liver disease (NAFLD), which is characterized by the accumulation of fat in the liver with no other apparent causes. AKN-083 is a potentially best-in-class preclinical farnesoid X receptor (FXR) agonist in development for the treatment of NASH, and is highly complementary to compounds in development by Tobira Therapeutics, Cenicriviroc (CVC) and Evogliptin. Allergan announced the acquisition of Tobira earlier today. "The acquisition of Akarna adds to our strategic approach to investing in innovation to advance the treatment of NASH for millions of patients who currently do not have therapeutic options to treat the disease," said Brent Saunders, CEO and President of Allergan. "We look forward to advancing this unique compound into later stages of development, and to advancing our overall portfolio of NASH programs, as we focus on bringing forward effective treatments for this critical disease area." "AKN-083 is a highly differentiated, selective FXR agonist which is a strongly validated therapeutic mechanism for the treatment of NASH," said David Nicholson, Chief Research & Development Officer, Allergan. "In addition, AKN-083 is a non-bile acid FXR agonist that in preclinical studies has shown high affinity, potency and selectivity with a better tolerability profile. These characteristics make AKN-083 a great addition to our portfolio of assets for the treatment of NASH." "We are excited to be working with Allergan, a company that shares our vision to develop the best possible treatments for NASH," said Raju Mohan, Ph.D., Founder and Chief Executive Officer, Akarna Therapeutics. "Allergan shares our commitment to help patients with NASH live longer, healthier lives." ]]> <![CDATA[Glenmark inks Licensing Agreement with Particle Sciences]]> https://biospectrumindia.com/news/95/8551/glenmark-inks-licensing-agreement-with-particle-sciences.html https://biospectrumindia.com/news/95/8551/glenmark-inks-licensing-agreement-with-particle-sciences.html Tue, 20 Sep 2016 11:17:25 +0530 Glenmark Pharmaceuticals, Inc., USA (Glenmark) has announced that it has entered into a strategic Development, License and Commercialization Agreement with Particle Sciences, Inc. to develop and market a generic version of Celgene's ABRAXANE product - paclitaxel protein (albumin)-bound particles for injectable suspension. As per the terms of the agreement, Glenmark has obtained Global Exclusive Marketing and Distribution rights of the product upon commercialization. Particle Sciences will develop this product exclusively for Glenmark, and shall receive certain milestone payments during various stages of the product's development from Glenmark, including royalties on sales. Development of the product has been initiated for the USA market and Glenmark intends to file the ANDA in FY19. The product will be subsequently filed in other key markets across the globe. "The partnership is a significant development in Glenmark's complex generics strategy and we are pleased to collaborate with Particle Sciences given their strong technical capabilities and understanding of particulate injection products. This is a challenging product to develop and we expect it to remain a limited competition opportunity." said Robert Matsuk, President - North America and Global API, Glenmark Pharmaceuticals Limited. ABRAXANE is paclitaxel protein (albumin)-bound particles for injectable suspension indicated for the treatment of Metastatic breast cancer, after failure of combination chemotherapy for metastatic disease or relapse within 6 months of adjuvant chemotherapy. Prior therapy should have included an anthracycline unless clinically contraindicated ï‚· Locally advanced or metastatic non-small cell lung cancer (NSCLC), as first-line treatment in combination with carboplatin, in patients who are not candidates for curative surgery or radiation therapy ï‚· Metastatic adenocarcinoma of the pancreas as first-line treatment, in combination with gemcitabine ]]> <![CDATA[Dr Reddy's Expands Strategic Collaboration with Amgen]]> https://biospectrumindia.com/news/95/8550/dr-reddys-expands-strategic-collaboration-with-amgen.html https://biospectrumindia.com/news/95/8550/dr-reddys-expands-strategic-collaboration-with-amgen.html Tue, 20 Sep 2016 11:16:49 +0530 Dr Reddy's Laboratories has announced that it has expanded its strategic collaboration with Amgen, one of the world's leading independent biotechnology companies, to market and distribute three of Amgen's medicines in India in the therapy areas of oncology and osteoporosis. Under the terms of the collaboration, Dr Reddy's will commercialise XGEVA®(denosumab), Vectibix® (panitumumab) and Prolia® (denosumab) in India. In 2015, Dr. Reddy's announced an initial strategic collaboration with Amgen to execute a full range of regulatory and commercial services to seek approval of and launch Amgen's Kyprolis® (carfilzomib), BLINCYTO® (blinatumomab) and RepathaTM (evolocumab) in India. The collaboration leverages the capabilities of both companies, combining Amgen's innovative therapies with Dr. Reddy's deep understanding of patient and physician needs in India. M.V.Ramana, Executive Vice President and Head of Emerging markets and India Business, Dr Reddy's Laboratories Limited said, "We are delighted to continue our relationship with Amgen as it strengthens our constant endeavor to enhance patient's access to novel treatment options across therapy areas. These medicines provide unique treatment options to physicians to address unmet medical need in the area of oncology and osteoporosis." Penny Wan, Amgen Vice President and General Manager, Japan Asia Pacific Region said, "We are happy to strengthen our relationship with Dr Reddy's. Amgen is committed to addressing unmet medical needs of patients in India, and we are pleased with the commitment Dr Reddy's has demonstrated toward making our medicines available in India as quickly as possible." XGEVA is a RANK ligand (RANKL) inhibitor and is approved in India for the prevention of skeletal related events in patients with advanced malignancies involving bone. Vectibix is an epidermal growth factor receptor (EGFR) antagonist approved in India for the treatment of adult patients with wild-type KRAS metastatic colorectal cancer (m-CRC) as first line treatment as monotherapy following disease progression, in wild type RAS m-CRC as first-line combination with FOLFOX and in second line in combination with FOLFIRI after prior treatment with fluoropyrimidine-based chemotherapy (excluding irinotecan). Prolia is a RANK ligand (RANKL) inhibitor approved in India for treatment of post-menopausal women with osteoporosis at high risk for fracture and also for treatment of increased bone mass in men with osteoporosis. Often referred to as the "silent epidemic," osteoporosis is a global problem that is increasing in significance as the population of the world both increases and ages. The World Health Organization (WHO) has recently identified osteoporosis as a priority health issue along with other major non-communicable diseases. issues. ]]> <![CDATA['Gender Diversity and Digitalization are new catalysts for Pharma']]> https://biospectrumindia.com/news/95/8549/gender-diversity-and-digitalization-are-new-catalysts-for-pharma.html https://biospectrumindia.com/news/95/8549/gender-diversity-and-digitalization-are-new-catalysts-for-pharma.html Tue, 20 Sep 2016 11:16:01 +0530 At the Organisation of Pharmaceutical Producers of India's (OPPI) annual HR summit on 'Sales Force Management', the role of diversity and digitalization in transforming the industry was actively discussed. In his inaugural address, Dr Shailesh Ayyangar, President, OPPI and Managing Director, India & Vice President, South Asia, Sanofi, said, "Pharmaceutical companies are quietly metamorphosing from being male-dominated, to developing a more inclusive culture with appreciation for better gender balance. The other important catalyst for change is this era of digitalization, which has changed the way our customers (physicians) and patients source information. Today, ipads are much more than mere e-detail aids. Multiple digital channels, including virtual reality, that can allow viewers to walk a mile in the shoes of someone living with dementia, for instance, are increasing the relevance of our contribution beyond our medicines and vaccines." "Marketing teams and sales forces are increasingly deploying advanced analytics to understand prescribing behavior and potential patient profiles; reflecting the transformation from bags and brochures to digitalization. Pharmaceutical companies are valuing non-traditional skill sets. Young professionals from industries, such as retail, telecom and other emerging sectors are more drawn to work in an industry that is transforming and hence, is a great place to build careers while also contributing to humanity." continued Dr Ayyangar. There was a cross-fertilisation of thoughts at the summit, amongst the distinguished speakers from various industries, who shared their experiences on skill development and building capability. Dr N.S Rajan, Group Chief Human Resources Officer, Tata Group in his key note address, highlighted, "The business of sales calls for stoicism. More attention and focus on formalized self development of sales personnel is critical. In today's changing world we need to redefine processes and as HR professionals, we aim to reorient thinking, policies and structures." TK Srirang, Group Head - Human Resources, ICICI Bank, in his address said, "The world is nebulous and changing. With the young nation of India becoming one of the fastest growing economies in the world, we are setting foot into a digital world. Automation is now a critical part of business models across sectors. There is an urgent need to invest in capacity and up skilling for the workforce to adapt to the changes of tomorrow." Highlighting the special session on diversity and inclusion, Kanchana TK, Director General, OPPI, said, "Any new HR intervention requires a clear strategic direction and strong focus from senior leadership. We see this happening right now in our industry. Leaders have begun to consciously look at inclusions, be it gender or ability and are constantly scouting for building assets in their respective teams. Today, building an inclusive HR capital is the success mantra for organisations to remain competitive." ]]> <![CDATA[Leading MedTech companies form Medical Technology Association of India (MTaI) to propel growth in the sector]]> https://biospectrumindia.com/news/95/8544/leading-medtech-companies-form-medical-technology-association-of-india-mtai-to-propel-growth-in-the-sector.html https://biospectrumindia.com/news/95/8544/leading-medtech-companies-form-medical-technology-association-of-india-mtai-to-propel-growth-in-the-sector.html Mon, 19 Sep 2016 16:01:51 +0530 Founded in India with an aim to accelerate the growth of medical technology sector, Medical Technology Association of India (MTaI - Pronounced Em-tai) mainly represents key research based multinational companies with significant investments in the country. In a short time of its formation, the association has taken vital steps to underpin the importance of the sector for a Healthy India. As per Mr Pavan Choudary, Director General, MTaI, "The Medical devices industry has huge potential to not only be able to significantly contribute to GDP of the country but also to the dream of Healthy India. The key industry players in India that include global and indigenous manufacturers and importers, have together contributed to growth of the sector." "MTaI recognizes the efforts made by the Government for the development of the MedTech sector. We are proud and simultaneously grateful for the fact that the PMO is directly nurturing it, that the Department of Pharmaceuticals, MOHFW, Niti Aayog, Ministry of Commerce, DIPP & CDSCO are all working in a spirit of inclusiveness which is ensuring that each responsible voice gets a hearing & due consideration. We thank the offices of Mr Ananth Kumar, Minister of Chemicals & Fertilizers & Mr J.P. Nadda, Minister of Health & Family Welfare and their Secretaries who are studying the various nuances of this sector to take informed decisions," added Pavan. Current data culled by MTaI reveals that investment in the medical devices sector shot up to US$ 161 million (in calendar year 2015) from US$ 60 million (Average annual yield) post the announcement of 100% FDI under automatic route in India in January 2015. "Progress on the FDI front shows a clear jump of US$ 101 million in less than a year's time, (US $ 161 million in 2015 over the average annual yield of @ US$ 60 Million). Though this is yet not proportionate to the potential of the Medical Technology sector; it is a sign what positive policies can do. During the same time the Pharmaceutical sector, Medtech's BIG brother, which usually brings nearly 15 times of the FDI brought in by Medtech I clocked an incremental FDI of only US$ 161 million over its average annual yield (just 1.6 times of Medetech this time!). Given appropriate thrust and direction, the trajectory of growth can be steeper, and this growth will not only significantly contribute to GDP of the country but also to the dream of a Healthy India. We seek the Government's help and support for a predictable, consistent and coherent policy & regulatory regime for Make in India, FDI & Business in general in the sector," Pavan elaborated. Stressing the need for a coherent & nuanced policy which ensures that technologies which will take much time to be import substituted are not made dearer to the patient, Milan Rao, CEO of GE Healthcare India, said, "India's medical devices sector is heavily underpenetrated with access limited to larger towns and cities. A majority of the market, especially of high-end medical equipment is imported. These equipments are critical in improving the health outcomes of millions of people, saving scores of lives and helping others lead healthier lives. A higher import tax rate will only make these products more expensive, increasing the financial burden on the healthcare system and reducing access further." "High-end medical technologies require many years of development and technical skills, and GE is already committed to developing such an ecosystem in India as part of its 'Make in India, for India and the World' efforts. A balanced approach where we address near term priorities of access and availability while simultaneously building the local ecosystem for the long term will help the medical devices sector flourish in India and ensure healthcare for all," added Milan. MTaI believes that global players in this sector have contributed significantly by bringing basic and advanced medical technologies to address patient needs in India, by investing in training of medical fraternity and thus creating the market, by bringing FDI and technology, by entering manufacturing due to consistent signals received from the Government so far. And that, it is also due to the ready availability of state of the art medical technology, that healthcare outcomes of many of our hospitals compare with the best in the world. The association also appreciates the efforts of the indigenous manufacturers who have contributed significantly to the sector through innovation and development of low cost basic devices and earning foreign exchange through exports. The policy makers and regulators need to nurture both, domestic and international groups in such a way that the 'Make in India' program continues for those sub sectors or product categories where a high level of import substitution of an acceptable quality has been obtained or can be obtained quickly while the technological & financial ecosystems get built for the balance sub sectors. This approach will help the Government foster this high gestation period sector, which needs deep pockets and substantive technology transfers continually. MTaI is an association of research based medical technology companies who have made remarkable investments in India. Its members have large number of R&D centres and medical technology manufacturing plants in India. The founding member companies include major names such as Johnson & Johnson, Bausch & Lomb, Smith & Nephew, C R Bard, Terumo, Boston Scientific and Vygon. Several other members have joined since its inception MTaI looks to partner with Government of India in setting a roadmap for growth of medical devices sector by bringing in even bigger investments in this sector, through 'Make in India and through technology upgradation and dissemination in the provider space. The association mentions that it has been all the time stressing on quality, consistency and patient safety-the three hall marks of success in this sector; and aspires to be the responsible voice of the Medical Technology Industry. According to MTaI, its goal also includes the promotion of good business practices in the industry. In that direction, the association says that it has not only adopted the enclosed internal code of conduct but also seeks Corporate governance policy/Ethics Policy/Undertaking from each of its members. ]]> <![CDATA[GSK sells anaesthesia portfolio to Aspen ]]> https://biospectrumindia.com/news/95/8545/gsk-sells-anaesthesia-portfolio-to-aspen-.html https://biospectrumindia.com/news/95/8545/gsk-sells-anaesthesia-portfolio-to-aspen-.html Mon, 19 Sep 2016 14:13:34 +0530 GlaxoSmithKline plc (GSK) has announced a series of agreements with Aspen aligned with GSK's strategy of simplification through focusing on core therapeutic areas. GSK will divest its anaesthesia portfolio to Aspen for £180 million plus milestones of up to £100 million. In addition to this divestment, GSK and Aspen have entered into parallel agreements to terminate their collaboration in Sub-Saharan Africa and for Aspen to exercise its option to acquire GSK's remaining thrombosis business in certain retained markets. The agreements announced are subject to the relevant anti-trust and regulatory clearances. GSK's anaesthesia portfolio consists of Ultiva, Nimbex, Tracrium, Mivacron and Anectine. GSK has previously divested this business in the US and Canada so no longer commercializes the products in these countries. Following termination of the current collaboration between GSK and Aspen across Sub-Saharan Africa ('SSA'), both parties will continue to commercialise their own respective portfolios in the region. The collaboration between GSK and Aspen in South Africa remains in place. In 2013, GSK divested its thrombosis portfolio to Aspen, but retained ownership of the franchise in certain territories ('Retained Markets' defined as China including Hong Kong and Macau, India and Pakistan). Aspen has now exercised the existing option to acquire the Retained Markets. GSK sales of the anaesthesia portfolio were £35 million in the first half of 2016. The remaining thrombosis portfolio at GSK had full-year sales of approximately £30 million in 2015. The net impact of the termination of the SSA collaboration and divestment of the thrombosis portfolio in the Retained Markets is not material to GSK. ]]> <![CDATA[Biocon appoints Suresh Subramanian as Head of Branded Formulations (India) business]]> https://biospectrumindia.com/news/95/8548/biocon-appoints-suresh-subramanian-as-head-of-branded-formulations-india-business.html https://biospectrumindia.com/news/95/8548/biocon-appoints-suresh-subramanian-as-head-of-branded-formulations-india-business.html Mon, 19 Sep 2016 12:30:03 +0530 Biocon Ltd, Asia's premier biopharmaceuticals company, announced that Mr Suresh Subramanian has been appointed as Senior Vice President & Head of the Company's Branded Formulations (India) business. Suresh has over 30 years of experience in the pharmaceuticals market, having worked in India and Thailand for MNCs such as GlaxoSmithKline, Novartis, AstraZeneca and Pfizer. Over the years, he has played multiple leadership roles in Business Development, Marketing, Sales and Strategy. He has a rich experience of multiple product launches, business optimization, cost control, talent development and performance management. Suresh has managed a wide portfolio spanning diverse therapy areas such as Neurosciences, Respiratory, Cardiology, Oncology, Critical Care, Gastro-Intestinal, Ophthalmology, Pain & Inflammation and Women's Health in the Indian market. He has also played a critical role in mapping the pharma opportunity in India as part of the Steering Committee for McKinsey's India Pharma 2020 report. Ms Kiran Mazumdar-Shaw, CMD, Biocon, said: "We are extremely delighted to have Suresh Subramanian lead our Branded Formulations business in India. Suresh has deep expertise in diverse therapy areas including Oncology, Cardiology and Critical Care and has a proven track record of delivering robust business growth. We are sure, under his leadership, our Branded Formulations business will evolve further and become a strong value builder for Biocon." Biocon's Branded Formulations (India) business is a biologics-led, specialty pharma business focused on the chronic therapy areas of diabetes, cancer and autoimmune conditions. Many of its key brands are leaders in their respective categories. ALZUMAb, a novel biologic developed by Biocon, is the world's first anti-CD6 monoclonal antibody introduced in India for Psoriasis. Insugen is the largest Indian Insulins brand, while Basalog is a leading Indian Insulin Glargine brand. CANMAb an affordable Trastuzumab for metastatic breast cancer has benefitted several thousand patients in India. Suresh Subramanian is a Physics graduate and has a Masters in Marketing Management from Mumbai University. ]]> <![CDATA[Allergan to buy US based Vitae Pharmaceuticals ]]> https://biospectrumindia.com/news/95/8522/allergan-to-buy-us-based-vitae-pharmaceuticals-.html https://biospectrumindia.com/news/95/8522/allergan-to-buy-us-based-vitae-pharmaceuticals-.html Thu, 15 Sep 2016 11:25:22 +0530 Allergan plc and Vitae Pharmaceuticals, Inc. has announced that they have entered into a definitive agreement under which Allergan will acquire Vitae for $21.00 per share, in cash, for a total transaction value of approximately $639 million. The Boards of Directors of both companies have unanimously approved the transaction. The acquisition will strengthen Allergan's dermatology product pipeline, with the addition of VTP-43742, a Phase 2 first-in-class, orally active RORÎ³t (retinoic acid receptor-related orphan receptor gamma) inhibitor for the potential treatment of psoriasis and other autoimmune disorders. VTP-43742 acts through the potent inhibition of IL-17 activity. The acquisition also adds VTP-38543, a topical LXRÎ² (Liver X Receptor beta) selective agonist for the potential treatment of atopic dermatitis. VTP-38543 is currently in a Phase 2a proof-of-concept clinical trial assessing the safety, tolerability and efficacy in patients with mild to moderate atopic dermatitis. Also read: Avara buys AstraZeneca UK Manufacturing Facility Vitae has developed and utilizes its Contour structure-based drug design platform to discover product candidates for validated therapeutic targets where biopharmaceutical research and development has traditionally struggled to develop drugs due to challenges related to potency, selectivity and pharmacokinetics. This has provided Vitae's R&D team the ability to create first-in-class product candidates for challenging therapeutic targets. "The acquisition of Vitae is a strategic investment for Allergan that adds strength and depth to our innovative medical dermatology franchise," said Brent Saunders, CEO and President of Allergan. "Vitae has pioneered the discovery and development of highly differentiated first-in-class compounds in atopic dermatitis, psoriasis and autoimmune diseases, areas of medicine where innovation is needed for patients." "The Vitae team has been tremendously successful in discovering and conducting early development work in areas of medicine that can benefit from significant innovation," said Jeff Hatfield, President and Chief Executive Officer of Vitae. "Allergan has a long track record in developing and commercializing innovative dermatologic treatments. I believe our programs will be poised for successful development as part of Allergan's portfolio. I am very proud of the tremendous contributions of our research teams and the clinical community who have led the discovery and development of our pipeline programs, and I thank them for their dedication to this science that may one day help many patients with dermatologic conditions, autoimmune disorders and potentially other conditions." Under the terms of the merger agreement, a subsidiary of Allergan will commence a cash tender offer to purchase all of the outstanding shares of Vitae common stock for $21.00 per share. The closing of the tender offer is subject to customary closing conditions, including U.S. antitrust clearance and the tender of a majority of the outstanding shares of Vitae common stock. The merger agreement contemplates that Allergan will acquire any shares of Vitae that are not tendered into the offer through a second-step merger, which will be completed promptly following the closing of the tender offer. Pending approvals, Allergan anticipates closing the transaction by the end of 2016. Debevoise & Plimpton LLP is serving as Allergan's legal counsel. J.P. Morgan is serving as financial advisor to Vitae and Gunderson Dettmer Stough Villeneuve Franklin & Hachigian, LLP is serving as Vitae's legal counsel. ]]> <![CDATA[US nod for ChemChina-Syngenta deal]]> https://biospectrumindia.com/news/95/8518/us-nod-for-chemchina-syngenta-deal.html https://biospectrumindia.com/news/95/8518/us-nod-for-chemchina-syngenta-deal.html Thu, 15 Sep 2016 11:25:06 +0530 China National Chemical Corporation (ChemChina) and Syngenta has announced that the companies have received clearance on their proposed transaction from the Committee on Foreign Investment in the United States (CFIUS). In addition to CFIUS clearance, the closing of the transaction is subject to anti-trust review by numerous regulators around the world and other customary closing conditions. Both companies are working closely with the regulatory agencies involved and discussions remain constructive. Also read: Glenmark bags FDA approval for Lidocaine Ointment The proposed transaction is expected to close by the end of the year. In February this year, ChemChina agreed to buy Syngenta in a transaction worth $43 billion ]]> <![CDATA[Bayer to acquire Monsanto for $66 billion]]> https://biospectrumindia.com/news/95/8516/bayer-to-acquire-monsanto-for-66-billion.html https://biospectrumindia.com/news/95/8516/bayer-to-acquire-monsanto-for-66-billion.html Thu, 15 Sep 2016 10:18:00 +0530 Bayer and Monsanto announced that they signed a definitive merger agreement under which Bayer will acquire Monsanto for USD 128 per share in an all-cash transaction. Monsanto's Board of Directors, Bayer's Board of Management and Bayer's Supervisory Board have unanimously approved the agreement. Based on Monsanto's closing share price on May 9, 2016, the day before Bayer's first written proposal to Monsanto, the offer represents a premium of 44 percent to that price. "We are pleased to announce the combination of our two great organizations. This represents a major step forward for our Crop Science business and reinforces Bayer's leadership position as a global innovation driven Life Science company with leadership positions in its core segments, delivering substantial value to shareholders, our customers, employees and society at large," said Werner Baumann, CEO of Bayer AG. Also read: Certara acquires d3 Medicine "Today's announcement is a testament to everything we've achieved and the value that we have created for our stakeholders at Monsanto. We believe that this combination with Bayer represents the most compelling value for our shareowners, with the most certainty through the all-cash consideration," said Hugh Grant, Chairman and Chief Executive Officer of Monsanto. Enhanced Solutions for Growers This transaction brings together two different, but highly complementary businesses. The combined business will benefit from Monsanto's leadership in Seeds & Traits and Climate Corporation platform along with Bayer's broad Crop Protection product line across a comprehensive range of indications and crops in all key geographies. As a result, growers will benefit from a broad set of solutions to meet their current and future needs, including enhanced solutions in seeds and traits, digital agriculture, and crop protection. The combination also brings together both companies' leading innovation capabilities and R&D technology platforms, with an annual pro-forma R&D budget of approximately EUR 2.5 billion. Over the mid to long-term, the combined business will be able to accelerate innovation and provide customers with enhanced solutions and an optimized product suite based on analytical agronomic insight supported by Digital Farming applications. These are expected to result in significant and lasting benefits for farmers: from improved sourcing and increased convenience to higher yield, better environmental protection and sustainability. "The agriculture industry is at the heart of one of the greatest challenges of our time: how to feed an additional 3 billion people in the world by 2050 in an environmentally sustainable way. It has been both companies' belief that this challenge requires a new approach that more systematically integrates expertise across Seeds, Traits and Crop Protection including Biologicals with a deep commitment to innovation and sustainable agriculture practices," said Liam Condon, member of the Board of Management of Bayer AG and head of the Crop Science Division. "We are entering a new era in agriculture - one with significant challenges that demand new, sustainable solutions and technologies to enable growers to produce more with less. This combination with Bayer will deliver just that - an innovation engine that pairs Bayer's crop protection portfolio with our world-class seeds and traits and digital agriculture tools to help growers overcome the obstacles of tomorrow. Together Monsanto and Bayer will build on our proud tradition and respective track records of innovation in the agriculture industry, delivering a more comprehensive and broader set of solutions to growers," said Grant. Value Creation Pro forma sales of the combined agricultural business amounted to EUR 23 billion in calendar year 2015. The combined company will be well positioned to participate in the agricultural industry with significant long-term growth potential. Beyond the attractive long term value creation potential of the combination, Bayer expects the transaction to provide its shareholders with accretion to core EPS (earnings per share) in the first full year after closing and a double-digit percentage accretion in the third full year. Bayer has confirmed sales and cost synergies assumptions in due diligence and expects annual EBITDA contributions from total synergies of approximately USD 1.5 billion after year three, plus additional synergies from integrated solutions in future years. Financing and Closing Conditions Bayer intends to finance the transaction with a combination of debt and equity. The equity component of approximately USD 19 billion is expected to be raised through an issuance of mandatory convertible bonds and through a rights issue with subscription rights. Bridge financing for USD 57 billion is committed by BofA Merrill Lynch, Credit Suisse, Goldman Sachs, HSBC and JP Morgan. Bayer has a proven track record of disciplined deleveraging after large acquisitions and believes that the strong cash flows of the combined business will contribute to improving its financial profile. Bayer targets an investment grade credit rating post-closing and is committed to the single "A" credit rating category over the long-term. The acquisition is subject to customary closing conditions, including Monsanto shareholder approval of the merger agreement and receipt of required regulatory approvals. Closing is expected by the end of 2017. The companies will work diligently with regulators to ensure a successful closing. In addition, Bayer has committed to a USD 2 billion reverse antitrust break fee, reaffirming its confidence that it will obtain the necessary regulatory approvals. Headquarters and Employees The combined agriculture business will have its global Seeds & Traits and North American commercial headquarters in St. Louis, Missouri, its global Crop Protection and overall Crop Science headquarters in Monheim, Germany, and an important presence in Durham, North Carolina, as well as many other locations throughout the U.S. and around the world. The Digital Farming activities for the combined business will be based in San Francisco, California. "This combination is a great opportunity for employees, who will be at the forefront of innovation in our sector. This transaction also enhances Bayer's strong commitment to the U.S., building on our 150-year history with operations across 25 states employing more than 12,000 people in the country. I am convinced that Monsanto will flourish as part of one of the most respected and trusted companies in the world," said Baumann. Bayer has extensive experience in successfully integrating acquisitions from a business, geographic and cultural perspective, and remains committed to its strong culture of innovation, sustainability and social responsibility. Advisors to the Transaction BofA Merrill Lynch and Credit Suisse are acting as lead financial advisors and structuring banks to Bayer in addition to providing committed financing for the transaction; Rothschild has been retained as an additional financial advisor to Bayer. Bayer's legal advisors are Sullivan & Cromwell LLP (M&A) and Allen & Overy LLP (Financing). Morgan Stanley & Co. and Ducera Partners are acting as financial advisors, and Wachtell, Lipton, Rosen & Katz is acting as legal advisor to Monsanto. ]]> <![CDATA[Another FDA approval in Glenmark's kitty]]> https://biospectrumindia.com/news/95/8515/another-fda-approval-in-glenmarks-kitty.html https://biospectrumindia.com/news/95/8515/another-fda-approval-in-glenmarks-kitty.html Wed, 14 Sep 2016 12:44:15 +0530 Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (U.S. FDA) for Diclofenac Sodium Gel, 3%, the generic version of Solaraze® Gel, 3% of Fougera Pharmaceuticals Inc. According to IMS Health sales data for the 12 month period ending July 2016, the Solaraze® Gel, 3% market1 achieved annual sales of approximately $297.9 million. Glenmark's current portfolio consists of 110 products authorized for distribution in the U.S. marketplace and 61 ANDA's pending approval with the U.S. FDA. In addition to these internal filings, Glenmark continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio. ]]> <![CDATA[Avara buys AstraZeneca UK Manufacturing Facility ]]> https://biospectrumindia.com/news/95/8514/avara-buys-astrazeneca-uk-manufacturing-facility-.html https://biospectrumindia.com/news/95/8514/avara-buys-astrazeneca-uk-manufacturing-facility-.html Mon, 12 Sep 2016 12:21:19 +0530 Avara Pharmaceutical Services, Inc. ("Avara") has announced that they have entered into an agreement under which Avara will acquire AstraZeneca's manufacturing facility located in Avlon, Avonmouth, England. Under the terms of the agreement, about 210 Avlon employees will remain employed at the site, and the plant will continue to manufacture critical AstraZeneca pharmaceutical products on a contract basis. AstraZeneca will continue to source a stable supply of high-quality products from the facility under the new ownership of Avara following the acquisition. Alos read: Danaher buys Cepheid for $4billion "We are excited to have the Avlon organization join the Avara team and to add this significant capability to the Avara Company," said Tim Tyson, Chairman and CEO of Avara. Tyson added, "We are honored to have the strategic partnership with AstraZeneca and to manufacture key products for them. We are excited to be able to transition this AstraZeneca center of technical excellence to a worldwide pharmaceutical services center of excellence. This exceptional facility will be the fifth site in our global network with other facilities in the US, Puerto Rico, Ireland and now the UK. "We thank the AstraZeneca employees in Avlon for their dedication, and we wish them well as they transition to Avara" said Marc Jones, EVP Supply, EMEA, at AstraZeneca. "We have confidence that Avara is the right company to oversee the continuing supply of the AstraZeneca products that are made at the facility, as well as to build a long term sustainable future for the site. We look forward to partnering with Avara as the new owner of the site to ensure the continuous supply of our products for the patients who need them." ]]> <![CDATA[Glenmark bags FDA approval for Lidocaine Ointment ]]> https://biospectrumindia.com/news/95/8513/glenmark-bags-fda-approval-for-lidocaine-ointment-.html https://biospectrumindia.com/news/95/8513/glenmark-bags-fda-approval-for-lidocaine-ointment-.html Mon, 12 Sep 2016 12:21:05 +0530 Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (U.S. FDA) for Lidocaine Ointment USP, 5%, the generic version of Xylocaine Ointment, 5% of AstraZeneca. According to IMS Health sales data for the 12 month period ending July 2016, the Xylocaine Ointment, 5% market achieved annual sales of approximately $373.0 million. Also read: Global coalition CEPI formed to tackle infectious diseases Glenmark's current portfolio consists of 109 products authorized for distribution in the U.S. marketplace and 62 ANDA's pending approval with the U.S. FDA. ]]> <![CDATA[Global coalition CEPI formed to tackle infectious diseases]]> https://biospectrumindia.com/news/95/8511/global-coalition-cepi-formed-to-tackle-infectious-diseases.html https://biospectrumindia.com/news/95/8511/global-coalition-cepi-formed-to-tackle-infectious-diseases.html Thu, 08 Sep 2016 21:53:13 +0530 The decision to play an active role and offering India's immense expertise in vaccine production and other capabilities in this new coalition, CEPI, was taken at a meeting attended by representatives of ABLE( Association of Biotechnology-Led Enterprises), CII ( Confederation of Indian Industry) and other vaccine experts in New Delhi on September 5, 2016 under the leadership of Dr VijayRaghavan. The Department of Biotechnology (DBT)and the Indian Vaccine leaders, coordinated by ABLE (Association of Biotech Led Enterprises) and CII (Confederation of Indian Industry) brain-stormed on India's potential role in a global initiative CEPI (Coalition for Epidemic Preparedness Innovations) that is being formed. Dr. K VijayRaghavan (Secy DBT) is the interim chair of the committee. Various suggestions were exchanged and would be firmed up in the coming months. The mood and the message was quite clear - that India had the wherewithal in terms of scientific talent and capacity to respond to any exigency, as was witnessed in case of H1N1 outbreak. Given the right incentives India could help countries, regional or international agencies to respond to any pandemic or epidemic in a quick, efficient and affordable manner. Going forward, the Government of India through DBT and the Indian Vaccine industry would work together to secure India citizens and others from potential epidemics. SARS, Ebola, Zika are diseases that have been in the news not only for the fatalities they cause but also for the fact that the outbreaks have been sudden and vicious. Moreover, there were no known Preventive or remedies at hand when they struck. There is now a strong global consensus about new and sustainable partnerships models that are needed for R&D of Vaccines to contain outbreaks of Epidemics of known and some possible diseases. India is a well-known, reliable producer of high quality and affordable vaccines of several life-threatening diseases and it is no surprise that globally one in every three children is immunized with Indian made Vaccines. Indian Vaccine industry has both the capability and capacity of tackling situations at short notice. ]]> <![CDATA[Danaher to buy Cepheid for $4 billion ]]> https://biospectrumindia.com/news/95/8508/danaher-to-buy-cepheid-for-4-billion-.html https://biospectrumindia.com/news/95/8508/danaher-to-buy-cepheid-for-4-billion-.html Thu, 08 Sep 2016 14:03:57 +0530 Danaher Corporation has entered into a definitive merger agreement with Cepheid pursuant to which Danaher will acquire all of the outstanding shares of Cepheid for $53.00 per share in cash, or a total enterprise value of approximately $4 billion including indebtedness and net of acquired cash. Cepheid is a leading and innovative global molecular diagnostics company that develops, manufactures, and markets accurate and easy to use molecular systems and tests. Headquartered in Sunnyvale, California, Cepheid will become part of Danaher's $5 billion Diagnostics segment, joining the Company's Beckman Coulter, Leica Biosystems and Radiometer businesses. Danaher's President and CEO, Thomas P. Joyce, Jr., said, "We expect Cepheid to be an excellent complement to our existing Diagnostics businesses and to expand our runway for growth across the platform. Cepheid's extensive installed base, test menu and innovative product offering contribute to its market leadership in molecular diagnostics and we expect it to strengthen our position in this high-growth segment." Also read: Allergan acquires gene therapy start-up Joyce continued, "By applying the Danaher Business System and combining Cepheid with our existing $5 billion revenue position in the diagnostics industry, we believe that Cepheid will be well-positioned to improve operational efficiencies, significantly expand margins and drive long-term growth. We look forward to welcoming the Cepheid team to Danaher." The acquisition has been unanimously approved by the Board of Directors of each company, and the Cepheid Board of Directors has unanimously recommended that Cepheid shareholders approve the transaction. The offer is subject to customary conditions, including approval by Cepheid's shareholders and receipt of applicable regulatory approvals. The transaction is expecteAllergan acquires gene therapy start-up d to be completed around the end of calendar year 2016. Danaher expects to finance the transaction with available cash and proceeds from the issuance of debt. ]]> <![CDATA[Mundipharma strengthens its consumer healthcare biz]]> https://biospectrumindia.com/news/95/8507/mundipharma-strengthens-its-consumer-healthcare-biz.html https://biospectrumindia.com/news/95/8507/mundipharma-strengthens-its-consumer-healthcare-biz.html Thu, 08 Sep 2016 11:41:22 +0530 Mundipharma has entered into a partnership that provides it with the commercial rights to market Munir Sukhtian Group's portfolio of HiGeen treatments in more than 50 countries across the Middle East, Africa and in Pakistan for ten years. The two companies have a long history of partnership in Jordan where Sukhtian group has been Mundipharma's distributor for several years. Munir Sukhtian group is a family-owned, diversified Jordanian company. Its HiGeen range includes best-selling hand sanitizers and other cosmeceuticals that are marketed in Europe, Asia and Latin America through distributors. Raman Singh, President of Mundipharma Asia Pacific, Latin America, Middle East and Africa, said "The HiGeen range complements our consumer health portfolio, which includes our BETADINE range, very well. The partnership will also help Mundipharma build on our strong leadership in the sector and help expand our presence." Also read: Cochlear launches first off-the-ear hearing device "Most importantly, Mundipharma's expertise in emerging markets will increase access to these important treatments for millions of people, which is very much in alignment with our strategy and vision." Deemah Sukhtian, Managing Director of Munir Sukhtian Group said, "The complementary nature of HiGeen and Mundipharma's products will ensure that both companies provide a stronger proposition to patients in the area of wound care and prevention of infectious diseases. We are confident that our alliance, leveraging on Mundipharma's expertise and global network, will enhance access to our innovative products and further improve the quality of life of patients and customers." The HiGeen portfolio includes a range of HiGeen Hand Sanitizers, HiGeen Harrar Massage Cream, HiGeen Barrad Cold Gel, HiGeen Daffaq Cream, HiGeen HerboHeal Jaddad Ointment, HiGeen Fungazi Foot Cream and HiGeen Fungazi Deodorizing Foot Powder. ]]> <![CDATA[Sun Pharma inks distribution pact with Japanese firm Mitsubishi pharma ]]> https://biospectrumindia.com/news/95/8506/sun-pharma-inks-distribution-pact-with-japanese-firm-mitsubishi-pharma-.html https://biospectrumindia.com/news/95/8506/sun-pharma-inks-distribution-pact-with-japanese-firm-mitsubishi-pharma-.html Thu, 08 Sep 2016 11:41:03 +0530 Sun Pharma has announced the initiation of a phased transfer of manufacturing & marketing rights in Japan for the 14 long-listed/established prescription brands acquired from Novartis. These 14 prescription brands acquired by the company earlier this year will be transferred from Novartis Pharma K.K. to Sun Pharma's subsidiary in Japan beginning October 2016. Sun Pharma has also signed a strategic distribution alliance with Mitsubishi Tanabe Pharma Corporation for these 14 prescription brands. Under this alliance, following the transfer of manufacturing & marketing rights to Sun Pharma's subsidiary in Japan, Mitsubishi Tanabe Pharma Corporation will market and distribute all the 14 brands as well as provide information on their proper use to healthcare professionals. Also read: Dr Reddy's launches new generic in the US According to Isao Muramatsu, President & Representative Director, Sun Pharma Japan Ltd, Sun Pharma, "Through this alliance we have the opportunity to leverage Mitsubishi Tanabe Pharma Corporation's specialized expertise to create a strong business foundation for us in Japan. Sun Pharma will focus on expanding its sales channels in Japan's pharmaceutical market while continuing to ensure a stable supply of medicines and healthcare information." ]]> <![CDATA[Dr Reddy's launches new generic in the US]]> https://biospectrumindia.com/news/95/8502/dr-reddys-launches-new-generic-in-the-us.html https://biospectrumindia.com/news/95/8502/dr-reddys-launches-new-generic-in-the-us.html Wed, 07 Sep 2016 12:20:30 +0530 Dr. Reddy's Laboratories announced that it has launched Bupropion HCl extended-release tablets, USP (SR) in 100 mg, 150 mg and 200 mg, a therapeutic equivalent generic version of Wellbutrin SR (bupropion HCl) Sustained-Release Tablets in the United States market approved by the U.S. Food & Drug Administration (USFDA). The Wellbutrin SR brand and generic had U.S. sales of approximately $109.6 million MAT for the most recent twelve months ending in July 2016 according to IMS Health. Also read: '8% of investments in start-ups are made in the healthcare sector' Dr. Reddy's Buproprion SR tablets are available in 100 mg, 150 mg and 200 mg, in bottle count sizes of 60, 100 and 500. Wellbutrin SR is a registered trademark of the GSK group of companies. ]]> <![CDATA[Allergan acquires gene therapy start-up ]]> https://biospectrumindia.com/news/95/8498/allergan-acquires-gene-therapy-start-up-.html https://biospectrumindia.com/news/95/8498/allergan-acquires-gene-therapy-start-up-.html Wed, 07 Sep 2016 12:16:50 +0530 Allergan plc and RetroSense Therapeutics LLC, a private, clinical-stage biotechnology company focused on novel gene therapy approaches to restore vision in patients suffering from blindness, announced that Allergan has acquired substantially all of the assets of RetroSense in an all-cash transaction. Under the terms of the transaction, Allergan has paid RetroSense a $60 million upfront payment, and has agreed to potential regulatory and commercialization milestone payments related to its lead development program, RST-001, a novel gene therapy for the potential treatment of Retinitis Pigmentosa (RP). "The acquisition of RetroSense and its RST-001 program builds on Allergan's deep commitment to eye care, and our focus on investing in game-changing innovation for retinal conditions, including Retinitis Pigmentosa, where patients desperately need treatment options," said Brent Saunders, CEO and President of Allergan. Retinitis Pigmentosa (RP) is a group of rare, inherited genetic disorders characterized by progressive peripheral vision loss and night vision difficulties followed by eventual central vision loss and blindness in many cases. Also read: Hot Start-ups: Monitoring the critical rhythm RST-001 is first-in-class gene therapy application of optogenetics, a therapeutic approach that confers light sensitivity to cells that were not previously, or natively, light sensitive. By applying optogenetics to retinas in which rod and cone photoreceptors have degenerated, the technology introduces additional light sensitivity to the retina. In 2014, RST-001 received an Orphan Drug Designation by the US FDA for the treatment of Retinitis Pigmentosa. The RST-001 optogenetic approach employs a photosensitivity gene, channelrhodopsin-2, to create new photosensors in retinal ganglion cells to potentially restore vision in retinal degenerative conditions. In August 2015, RetroSense's Investigational New Drug (IND) application for RST-001 received clearance from the United States Food and Drug Administration (FDA). In March 2016, RetroSense initiated a Phase I/IIa clinical trial to evaluate the safety of RST-001 in patients being dosed, and in August 2016, the low dose cohort of patients had been safely dosed. "The RST-001 program and its optogenetic gene therapy approach could be a real breakthrough in the treatment of unmet needs across a host of retinal conditions, including RP," said David Nicholson, Chief Research and Development Officer, Allergan. "The team at Allergan is excited by the prospect of advancing an entirely new approach in the treatment of retinal diseases, and this technology is highly complementary to our ongoing development programs in this critical treatment area." "With its deep commitment to eye care, strong eye care professional community network, and its commitment to advancing innovation across retinal conditions, Allergan was the most compelling partner and the best strategic fit to advance the development of RST-001 and maximize the potential for this technology platform," said Sean Ainsworth, former CEO of RetroSense Therapeutics. "The addition of RST-001 to Allergan's world-class eye care development and commercialization organization will position this potentially revolutionary technology to be used by ophthalmology professionals to improve the treatment of patients with retinal diseases around the world." ]]> <![CDATA[India's diagnostics queen]]> https://biospectrumindia.com/interviews/95/8504/indias-diagnostics-queen.html https://biospectrumindia.com/interviews/95/8504/indias-diagnostics-queen.html Tue, 06 Sep 2016 13:20:00 +0530 Despite the hard struggles in a male-dominated society, women have fought bravely and stood their grounds against all odds. Ms Ameera Shah, the MD and promoter of Mumbai-based Metropolis Healthcare, isn't an exception either. Though she took over her father's business, the journey wasn't a cake walk. She was often mistaken for a secretary, and had to overcome gender discrimination and belittling from junior male colleagues. In her exclusive interview to BioSpectrum, she shares her insights on Indian diagnostics scene, the company's next market expansion plans, and ultimately her own entrepreneurial struggles and immeasurable efforts in building her own diagnostics kingdom. Excerpts:Q: What trends are shaping up the Indian diagnostics space? Ameera Shah: The most important trend today that we observe is the heightened awareness of the new age customer. They take their health in their own hands, take preventive measures and want to lead a healthy lifestyle. For today's customer, health is about wellness rather than the absence of illness which is an extremely wonderful trend. On the technical side, there was a time when doctors from India sent blood samples abroad for hormone and thyroid testing. Scope of diagnosis was extremely limited in India. My father, Dr Sushil Shah, saw an opportunity and brought many new tests and technologies to India for the first time. Q: Tell us about your major growth drivers in India and other countries. AS: Cutting-edge technology, innovative work equipments, expansive logistics network and rigorous processes are the keys to Metropolis' growth in the country. These allow us to deliver precision and accuracy in every single test. Additionally, Metropolis has expanded into new service lines such as clinical trials, hospital lab management, home health services, preventive health check-ups, and corporate and wellness solutions. Q: What are the challenges in building a diagnostics business in India? AS: There are multiple challenges when you start expanding. In India, the dynamics of each city is different. What works in Surat may not work for Patna or Cochin. While entering each new market whether through a green field or an acquisition, it is important to study the market in depth and cut strategies accordingly. In India, each state and each city is penetrated like a new market. Some of the broad challenges in India can be summarized as lack of trained talent, cost of infrastructure, cost and volume dilemma and pricing challenge. Q: What factors do you consider while entering a new market? AS: Entering new markets, as it may seem, is not really easy. In case of a diagnostic business, we have to look after the following parameters including local competition, brand recognition and recall, economic markets, political and policy scenario, and legal jurisdictions. Q: Which markets would you be expanding to in the next couple of years? AS: We want to extensively expand in the North Indian region and Africa specifically. Moreover, we are delving deeper into the geographic regions in all countries where we are already present. We see potential in our growth in the African continent where we are gradually expanding since the last five years. Q: Which areas in diagnostics are still untapped or needs more attention? AS: While corporate players have ensured standardization of processes, it is important that government takes measures to bring in regulation to the diagnostic sector. A change in the regulatory scenario can transform the landscape of the industry. Accreditation need to be made mandatory so as to ensure labs maintain basic protocol. This will ensure more accurate reports, right diagnosis and disease management and in-turn better healthcare costs for the masses. Q: Any M&As on the cards? AS: Our current plans are to expand geographically within regions we are already present in. We will make any announcements for mergers or acquisitions whenever they are in the pipeline. Q: Are there any advantages in being a woman in this industry? AS: There are no advantages in this industry for women. From my personal experience, I would like to highlight that the diagnostic industry isn't the easiest to enter especially for a woman. There are a lot of preconceived notions attached to women. My first challenge was to change Metropolis from a sole proprietorship to a company. Being a woman entrepreneur, I had to face multiple instances of gender discrimination, which meant from being mistaken for a secretary to constantly being undermined by my junior male colleagues. This industry is dominated largely by men and for me to make a mark I have struggled my way through. Many may think it's a family business and would have been easy for me, which is definitely not the case. I have taken a lot of time and put in immeasurable effort to bring Metropolis to these heights. Q: Message to all the Indian women entrepreneurs? AS: In India, from the very beginning women are taught that their greatest asset is gold or jewelry. I strongly believe that for any woman, not just a woman entrepreneur, her greatest asset is her confidence - confidence to make her choices; be it personal or professional life. I will urge all women to embrace their right to confidence. While the society might take time to transform completely, women can start introducing gradual changes in their lives. This will lead up to the process of self discovery. The gender battles that women generally face in the workplace and the ones that a women entrepreneur will face are different. For a woman businessperson, because you are in charge of building the organization and the culture, the situation is unquestionably different. But for a woman entrepreneur, you have to go out and sell your story because you are building your own brand. Q: How do you manage work-life balance? AS: While it's not easy to take time out of the daily grind, I try to remove some time for myself every week. I regularly play tennis and work out at least thrice a week. I love the outdoors and so try to get in some sailing, camping and trekking whenever possible. Any down time I get is divided between activities that boost my physical and mental health, and spending with my loved one. Q: What next for Metropolis? AS: Metropolis is amongst the top 1 percent labs in the world in terms of quality and accuracy of reports. We want to gain more market share in North India and hence going more aggressive in the north. We have been in an expenditure phase for the past two to three years where we have been investing in our people, infrastructure, distribution, network and sales. Now I am hopeful about experiencing the results of the work we've been doing. Q: When do you think Metropolis will be ready for its IPO debut? AS: It might be ready in the long run, however, not right now. ]]> <![CDATA['8% of investments in start-ups are made in the healthcare sector']]> https://biospectrumindia.com/news/95/8497/8-of-investments-in-start-ups-are-made-in-the-healthcare-sector.html https://biospectrumindia.com/news/95/8497/8-of-investments-in-start-ups-are-made-in-the-healthcare-sector.html Tue, 06 Sep 2016 13:17:26 +0530 The road ahead for India's healthcare sector is set to be revolutionized with the rising base of healthcare start-ups that recognize the need for making quality healthcare accessible to India's billion plus population, according to a joint study by FICCI and KPMG in India titled - 'Indian healthcare start-ups - An inside look into funding'. Launched at FICCI's annual healthcare conference - FICCI HEAL 2016, the knowledge paper evaluates the role and need for healthcare start-ups in India, their evolution in the sector and the funding scenario. It also assesses the future of these start-ups, highlights some of the challenges being faced by them and suggests a way forward. Dr Nandakumar Jairam, Chair, FICCI Health Services Committee; Chairman, NABH and Chairman and Group Medical Director, Columbia Asia Hospitals India said, "What we need today is a unified approach for long-term solutions that would help in optimizing disease-care to preventive and promotive care as well as patient centricity though data - driven efficient technologies. Fostering Start-ups and Entrepreneurship will provide the requisite innovative approach for achieving these reforms." Also read: IMS Health, Quintiles announce Key Officers for Merged Company Vishal Bali Chair, FICCI HEAL 2016 Organizing Committee; Co-Chair, FICCI Health Services Committee & Co-founder & Chairman, Medwell Ventures said, "Start-ups are already disrupting the way healthcare is delivered in India. According to the NASSCOM Start-up Ecosystem Report 2015, India serves as the fastest growing start-up-base worldwide and 6-8% of the recent B2C Start-ups in India have been in the Health-tech sector. This means that the sector has already secured ample traction from investors owing to its huge potential." Nilaya Varma, Partner and Head, Government and Healthcare, KPMG in India, said, "Healthcare start-ups in India have potential to emerge as new enabler of accessible and affordable healthcare services. Many start-ups have moved away from traditional healthcare delivery models to asset light, technology based and enabling platforms for patients & healthcare providers. However, start-up continue to face some encounters in terms of funding, incubation and regulatory environment. The government's Start-up India initiative intends to bridge some of the challenges and provides encouraging ecosystem for start-ups. In the recent past increasing number of HNIs, seed funds, incubators and other private investors have extended support to start-ups. The creation of conducive ecosystem for healthcare start-ups will be boon for the healthcare sector." With a doctor patient ratio as low as 1:1700 (in proportion to the total population), stumped penetration of healthcare in rural areas and a low medically insured population, the potential for healthcare start-ups to emerge as a key member in the healthcare ecosystem is vast. Domestically, healthcare start-ups have not yet received a steady stream of funding to support their ventures with capital as low as USD27 million in the first four months of 2016. The challenges to garner fund flow is hindering multiple projects, ideas, concepts and approaches from taking off. Private sector investments alone are not sufficient to boost the necessary change and the government needs to shoulder the dual responsibility of a guide and an investor to create a sound healthcare system to keep up with global standards. India's healthcare system is vast and disorganized; however it contributes largely to the total workforce. Healthcare start-ups are likely to engage in extended innovative Research and Development (R&D), in turn increasing their accessibility to the larger population and creating greater scope for employment generation. Other key finding presented in the knowledge paper are as follows: â€¢ Start-ups can act as a much needed facilitator to help approximately 70 per cent of the rural population with limited or no access to hospitals or clinics.â€¢ Mobile and internet platforms can be one of the means to address India's deficient healthcare facilities, via innovation in technology and telemedicine. This could result in better diagnosis by doctors making the history of patients available on cloud platforms.â€¢ The start-up domain is struggling to rope in the right investors and arrange for adequate funding, which could largely be attributed to the slow pace of growth in the sector. It takes anywhere between 10 to 15 years to introduce a new product in the market with very few prevalent business models to compare with.â€¢ India's public spending on the healthcare sector comprises of only 1.4 per cent of the GDP and is amongst the lowest in the world.â€¢ Private sector stakeholders could play a crucial hand in the growth and development of healthcare start-ups, by investing in high-risk which could enable entrepreneurs to bring medical advancements and generate higher returns for them. Healthcare start-ups could transform the future of the sector by bridging the gap between ]]> <![CDATA[Kiran Mazumdar Shaw appointed 'Knight of the Legion of Honour' ]]> https://biospectrumindia.com/news/95/8496/kiran-mazumdar-shaw-appointed-knight-of-the-legion-of-honour-.html https://biospectrumindia.com/news/95/8496/kiran-mazumdar-shaw-appointed-knight-of-the-legion-of-honour-.html Tue, 06 Sep 2016 13:17:14 +0530 Dr Kiran Mazumdar Shaw, Chairperson & Managing Director of Biocon has been appointed 'Chevalier de l'Ordre National de la LÃ©gion d'Honneur' (Knight of the National Order of the French Legion of Honour) for her outstanding contribution and dedication to the Biosciences and Research field globally. The award will be conferred on behalf of the President of the French Republic at a special ceremony later this year. "It is an absolute privilege for me to be appointed 'Chevalier l'Ordre National de la LÃ©gion d'Honneur' and I am deeply grateful to the French Government for this great honour. I owe this recognition to my wonderful team at Biocon who have joined me in my mission to harness the power of Biotechnology to provide affordable access to life saving biopharmaceuticals for Cancer and Diabetes" Kiran Mazumdar Shaw, Chairperson & Managing Director of Biocon. Chevalier l'Ordre National de la LÃ©gion d'Honneur, created in 1802, by Napoleon Bonaparte, is the highest civilian award of the French Republic for outstanding contribution in diverse fields bestowed on citizens of the world. The award is conferred by the President of the French Republic. Other Indians to have received this honour in the past are: Yashwant Sinha, Narayana Murthy, Amitabh Bachchan, Aishwarya Rai, Nandita Das, Shah Rukh Khan, veteran musician Balamuralikrishna, Sivaji Ganesan amongst others. ]]> <![CDATA[Biolubricants market worth $3.15 bn by 2021]]> https://biospectrumindia.com/features/95/8380/biolubricants-market-worth-3-15-bn-by-2021.html https://biospectrumindia.com/features/95/8380/biolubricants-market-worth-3-15-bn-by-2021.html Fri, 26 Aug 2016 15:35:56 +0530 According to a new market research report published by MarketsandMarkets, the global biolubricants market size, which was $2.20 billion in 2015, is projected to reach $3.15 billion by 2021, at a CAGR of 6.3% between 2016 and 2021. Increasing environmental regulations such as the Vessel General Permit (VGP) and Ecolabels in the developed markets such as the US and European countries, and new and upcoming firms involved in the R&D of biolubricants are projected to drive the biolubricants market during the forecast period. Hydraulic fluids application accounted for the maximum share of the market, in terms of value, in 2015. They are used in both stationary and mobile equipment such as hydraulic elevators, sweepers, garage trucks, forklifts, motor graders, and front-end loaders. High degree of biodegradability and low toxicity is essential for hydraulic fluids to be environmentally safe. Biolubricants as hydraulic fluids are preferred in areas where contamination can harm the environment. The demand for environment friendly hydraulic fluids is driven by several stringent regulations in sensitive areas such as marine and forest. The industrial segment accounted for the largest share in terms of value, of the overall biolubricants market in 2015. There are a number of environmental legislations in developed European countries such as Germany, Italy, and Scandinavian countries, where awareness regarding environmental hazards of mineral oils is high. Increasing environmental awareness is causing a shift in consumption patterns to biolubricants in industrial uses. Commercial transport is projected to be the fastest-growing end use of biolubricants during the forecast period. This is due to the concerns raised by the disposal of mineral-based lubricants into the environment. Approximately 20 to 30 percent hydraulic fluids used in the commercial transport sector are released in the environment through leakage or hose ruptures. Europe is the prime consumer of biolubricants, globally, that accounted for the maximum share of the biolubricants market in 2015. North America is projected to register the highest CAGR between 2016 and 2021, backed by the stringent regulations such as Vessel General Permit and BioPreferred Program. North America is expected to dominate the biolubricants market by 2021, with high investments from manufacturers for new product launch and the expansion of production capacities to increase the market dominance. The major players covered in the report are Fuchs Petrolub (Germany), Panolin (Switzerland), Cargill (US), Total (France), BP (UK), Exxon Mobil (US), Binol Lubricants (Sweden), Kluber Lubrication MÃ¼nchen (Germany), Emery Oleochemicals Group (Malaysia), and Albemarle Corporation (US). ]]> <![CDATA[Patent applied for thalassemia through nutraceuticals]]> https://biospectrumindia.com/news/95/8381/patent-applied-for-thalassemia-through-nutraceuticals.html https://biospectrumindia.com/news/95/8381/patent-applied-for-thalassemia-through-nutraceuticals.html Fri, 26 Aug 2016 12:16:09 +0530 Thalassemia is a disorder of abnormal formation of hemoglobin and thereby destruction of red blood cells. Several approaches have been used for treating patients with thalassemia including blood transfusions, splenectomy, iron chelation therapy, modulation of foetal haemoglobin and other agents focusing on specific aspects of clinical presentation. However the exact management of the disease is still controversial. "A major issue which is not entirely explored is the effect of blood transfusion in the management of patients with thalassemia. There are certain advantages and disadvantages of initiating blood transfusions in Thalassemia patients that must be always taken into account in the management of these patients. Therefore, complications that interact with the clinical outcome of treatment and also patient's quality of life can be avoided to some extent. Besides this there is no absolute other treatment available in the market that promotes production of red blood cells", says Dr Agrawal. Also read: Strides Shasun receives USFDA approval for Ranitidine tablets Having said this, blood transfusion is also associated with a possible complication named iron overloading. "To resolve this complexity we have created an evidence based nutraceutical formulation which is a combination of multivitamins, amino acids and other important nutraceuticals which boosts up hemoglobin level and red blood cell. Nutraceuticals by adding, hemoglobin level in thalassemia patients improves quality of life. It does have direct effect on bone marrow processing units and provides enough supplements of amino acids and minerals which body does not make in this disease process. Another important advantage of nutraceuticals, being low cost and easy availability, it can be replaced with blood transfusion which is difficult to available and expensive also. Multivitamins supplements, proper diet, calorie and protein intake are very important ways to boost body's immune defense in thalassemia. In addition it does not linked up with side effects", he adds. This patent applied formulation has been developed in Dr. Agrawal's lab and took more than three years. This unique formulation is developed by Dr Sanjay Agrawal who is already inventor of 40 patented formulations. ]]> <![CDATA[Eisai to launch Chocola BB mouth ulcer repair shot ]]> https://biospectrumindia.com/news/95/8214/eisai-to-launch-chocola-bb-mouth-ulcer-repair-shot-.html https://biospectrumindia.com/news/95/8214/eisai-to-launch-chocola-bb-mouth-ulcer-repair-shot-.html Thu, 25 Aug 2016 14:45:05 +0530 Eisai Co., Ltd. announced that it will launch "Chocola BB Mouth Ulcer Repair Shot"(Third-class OTC drug) for mouth ulcers in Japan on Thursday, August 25. The product is the first oral care spray to be marketed under the Chocola BB brand. Mouth ulcer is a general term that refers to any inflammation of the mucous membrane in the mouth. In many cases, it is thought that nutritional imbalances, lifestyle changes and/or stress lead to a decrease in the mucous membrane's ability to regenerate, allowing bacteria to penetrate the membrane and cause an ulcer to form. Also read: FDA allows marketing of first-of-kind computerized cognitive tests Chocola BB Mouth Ulcer Repair Shot is a medicated spray that is effective for mouth ulcers and soothing pain caused by inflammation in the throat. Containing antiseptic cetylpyridinium chloride (CPC) that keeps the mouth clean, as well as azulene which acts to repair the mucous membrane, the spray alleviates the symptoms of mouth ulcers by allowing the active ingredients to be directly applied into the mouth. It also comes in a compact form making it portable and easy to use anywhere without having to directly touch the affected area. Centered around the signature OTC product Chocola BB Plus (Third-class OTC drug) for the relief of skin trouble, acne and mouth ulcers, Eisai has been expanding the Chocola BB brand to suit the needs and lifestyles of its customers such as Chocola BB Royal 2 (quasi-drug), a nutritional drink for invigoration when physically fatigued, and Chocola BB Joma, a soft drink that contains vitamin B6 (Food with Nutrient Function Claims). Through the Chocola BB brand, Eisai will continue to respond to the diverse needs of female consumers and support an ever-growing number of people to achieve health and beauty in their everyday lives. ]]> <![CDATA[Pfizer on acquisition spree, buys AZ's antibiotic biz]]> https://biospectrumindia.com/news/95/8211/pfizer-on-acquisition-spree-buys-azs-antibiotic-biz.html https://biospectrumindia.com/news/95/8211/pfizer-on-acquisition-spree-buys-azs-antibiotic-biz.html Thu, 25 Aug 2016 14:43:48 +0530 AstraZeneca has announced that it has entered into an agreement with Pfizer Inc. (Pfizer) to sell the commercialisation and development rights to its late-stage small molecule antibiotics business in most markets globally outside the US. The agreement reinforces AstraZeneca's focus on developing transformational medicines in its three main therapy areas, while realising value from the strong portfolio of established and late-stage small molecule antibiotics through Pfizer's dedicated commercialisation and development capabilities in anti-infectives. The portfolio comprises the approved antibiotics Merrem, Zinforo and Zavicefta, and ATM-AVI and CXL, which are in clinical development. Under the terms of the agreement, Pfizer will make an upfront payment to AstraZeneca of $550 million upon completion and a further unconditional payment of $175 million in January 2019 for the commercialisation and development rights to the late-stage antibiotics business in all markets where AstraZeneca holds the rights. In addition, Pfizer will pay up to $250 million in commercial, manufacturing and regulatory milestones, up to $600 million in sales-related payments as well as recurring, double-digit royalties on future sales of Zavicefta and ATM-AVI in certain markets. Also read: Mega Merger: Pfizer buys Medivation for $14 billion Luke Miels, Executive Vice President for Europe and Head of the Antibiotics Business Unit at AstraZeneca, said: "This agreement reinforces our strategic focus to invest in our three main therapy areas where we can make the greatest difference to patients' lives. We're pleased that our strong science in antibiotics will continue to serve a critical public health need through Pfizer's dedicated focus on infectious diseases, ensuring these important medicines reach greater numbers of patients around the world." John Young, Group President, Pfizer Essential Health, said: "As we continue to reshape our Essential Health portfolio, we are focusing on areas that further address global public health needs and that complement our core capabilities and experience in therapeutic areas, including anti-infectives. We are committed to looking for ways to enhance our portfolio around the world where we offer patients and healthcare professionals access to more than 60 anti-infective and anti-fungal medicines. The addition of AstraZeneca's complementary small molecule anti-infectives portfolio will help expand patient access to these important medicines and enhance our global expertise and offerings in this increasingly important area of therapeutics, in addition to providing the opportunity for near-term revenue growth." MedImmune's portfolio of biologics, on-market products such as FluMist/Fluenz and Synagis, and AstraZeneca's stake in Entasis Therapeutics, spun-off from AstraZeneca in 2015 and now operating as a stand-alone company focused on the development of innovative small-molecule anti-infectives, are not included as part of the agreement. The agreement with Pfizer is expected to close in the fourth quarter of 2016, subject to customary closing conditions. As AstraZeneca will de-recognise an intangible product asset and does not maintain a significant future interest in the late-stage small molecule antibiotics business all payments will be reported as Other Operating Income in the Company's financial statements. This includes the upfront payment of $550 million and unconditional payment of $175 million in 2019 (both to be recognised net of the aforementioned product intangible in 2016), the milestones of up to $250 million, the sales-related payments of up to $600 million and the recurring double-digit royalties on sales of Zavicefta and ATM-AVI. AstraZeneca's established antibiotic medicines Merrem and Zinforo are available in more than 100 countries and generated Product Sales in 2015 of $250 million. The agreement does not impact AstraZeneca's financial guidance for 2016. ]]> <![CDATA[Strides Shasun receives USFDA approval for Ranitidine tablets]]> https://biospectrumindia.com/news/95/7698/strides-shasun-receives-usfda-approval-for-ranitidine-tablets.html https://biospectrumindia.com/news/95/7698/strides-shasun-receives-usfda-approval-for-ranitidine-tablets.html Wed, 24 Aug 2016 15:11:15 +0530 Strides Shasun Limited today announced that it has received approval from the United States Food & Drug Administration (USFDA) for Ranitidine Tablets USP, 150 mg and 300 mg. Ranitidine tablet is the first integrated product approval where the API and formulations will be manufactured at erstwhile Shasun Pharmaceutical's Cuddalore and Pondicherry facilities respectively. According to IMS data (MAT June 2016), the US market for Ranitidine Tablets USP, 150 mg and 300 mg. is approximately USD 125 Million. The product to be launched immediately will be marketed by Strides Pharma Inc in the US Market. Also read: Vyome Biosciences closes $14 million series C financing ]]> <![CDATA[Abbott, BD, Bio-Rad likely to continue dominance in Microbiology testing market]]> https://biospectrumindia.com/features/95/7699/abbott-bd-bio-rad-likely-to-continue-dominance-in-microbiology-testing-market.html https://biospectrumindia.com/features/95/7699/abbott-bd-bio-rad-likely-to-continue-dominance-in-microbiology-testing-market.html Wed, 24 Aug 2016 14:59:57 +0530 According to market research firm Mordor Intelligence, the global market for microbiology testing is estimated to be $3.35 billion in 2016, and is expected to reach $5.77 billion by 2021, growing at a compound annual growth rate (CAGR) of 11.5% during the forecast period. North America accounts for the highest market share due to presence of large number of market-focused key players providing a wide range of product portfolio. However, Asia-Pacific is expected to grow at the highest CAGR due to expanding research in the development of new and innovative microbiology testing procedures. An increasing number of hospitals and testing laboratories as well as a rising incidence of diseases across India, China& Japan are factors promoting the microbiology testing market. Other market driving factors include - technological advancements in pathogen identification; rising incidence of infectious diseases & outbreak of epidemics; growing healthcare expenditure and a rising private-public research funding. Laboratory reimbursement issues and high cost of microbiology instruments are expected to restrain the market growth during the forecast period. See Also: Global Bioinformatics market to touch $30.87 bn by 2020 ]]> <![CDATA[Biotech Student Entrepreneurship contest for 2016 announced]]> https://biospectrumindia.com/news/95/7528/biotech-student-entrepreneurship-contest-for-2016-announced.html https://biospectrumindia.com/news/95/7528/biotech-student-entrepreneurship-contest-for-2016-announced.html Wed, 24 Aug 2016 09:45:22 +0530 BEST 2016, the Biotech Student Entrepreneurship facilitation program for 2016 has been announced. This unique program encourages Biotech students to submit business ideas to explore the possibility of pursuing the spirit of discovery, development, and entrepreneurship. "The objective of the program is to create entrepreneurial mind-set, raising an individual's motivation and capacity, independently to identify an opportunity as well as to pursue it in order to produce new value or economic success," said Dr Shailja Gupta, Scientist F, Department of Biotechnology (DBT). Students need to form a 5-member team and register their concept notes before 15th September 2016. (http://www.ableindia.in/best2016/registration-form/). A Panel of experts will screen the applications and shortlist 20 teams. These 20 teams will then be called to attend a fully-paid high quality Entrepreneurship Workshop in New Delhi on December 7-11, 2016. This business ideas workshop-cum-contest will familiarize the contestants on matters related to starting a business venture like Business Plans, IP & Patenting Strategies, Raising Finance, Business Strategies, HR Practices and Communication Skills. At the end of the Workshop, each team will develop a business plan based on their Concept and learning from the Workshop and make a ten minute power point presentation to the Jury. The Jury will evaluate and critique each of the business plans and identify 5 winning teams. The winning team with the best business plan will receive Rs 5 Lakh as first prize. There will be two second prizes Rs 3 Lakh each and two third prizes of Rs 2 Lakh each. Launched in 2009 by ABLE (the Association of Biotechnology Led Enterprises), with the support of Department of Biotechnology (DBT), Government of India the, Biotechnology Entrepreneurship Student's Team (BEST) is a unique scheme to promote entrepreneurship. The program since its inception has been the feed for the emerging biotech industry with technically skilled resources. The uniqueness of the program lies in the very concept, wherein the targeted community is the ever inquisitive and enthusiastic students. Also, the modus operandi and execution of the program where there is a thorough induction and training exercise for multiple days, and thereby giving shape and direction to the raw ideas which students bring with themselves. A program which guarantees the nation a skilled and quality entrepreneurial future. "The biotech start-up boom is on and the enthusiasm is there for everyone to see. And BEST has become the platform for success of this culture," noted Dr Renu Swarup, Advisor, Department of Biotechnology, Ministry of Science & Technology Government of India and Managing Director Biotechnology Industry Research Assistance Council (BIRAC) at a recent meeting on Biotech Innovation in Bangalore. This much awaited forum is for young B.E/ B. Tech, postgraduate and doctoral students in life sciences to realize their entrepreneurial dreams. The objective of the program is to create entrepreneurial mind-set, raising an individual's motivation and capacity, independently to identify an opportunity as well as to pursue it in order to produce new value or economic success. This student oriented program BEST for this year 2016 is in its eighth edition, and the last date for submission of applications is 15 September 2016. The theme for applications invited this year should necessarily focus on Water contamination Food borne Pathogens Waste management Bioengineering - Diagnostics & Solutions for Important diseases (Human, Crops, Livestock) including Devices, Kits, Chip-based tools etc. Water management (Drinking & Irrigation) The complete details of the contest and program are available at http://www.ableindia.in/best2016/. The teams can also approach either the chief operating officer of ABLE, Mr Narayanan Suresh (coo@ableindia.org.in ) or the program manager of BEST, Ms Sonali Ghosh (sonalig@ableindia.org.in). BEST so far: Since the inception of the program in 2009, nearly 820 student teams have participated in the BEST program. Further and estimated 3,513 students and research scholars have benefited from this exercise. The seven editions have seen participation from 55 universities, research institutes and colleges across India and nearly 557 young minds have been trained so far. Further, nearly 15 of the BEST winners from the past seven editions have gone on to create start-ups. ]]> <![CDATA[White Biotechnology market to reach $262.3 bn by 2024]]> https://biospectrumindia.com/features/95/8423/white-biotechnology-market-to-reach-262-3-bn-by-2024.html https://biospectrumindia.com/features/95/8423/white-biotechnology-market-to-reach-262-3-bn-by-2024.html Tue, 23 Aug 2016 14:12:21 +0530 Rising at this pace, the market, which held an opportunity of $178.1 bn in 2015, will reach $262.3 bn by 2024. The global market for white biotechnology is largely consolidated, with the top five companies collectively accounting for over 71% of the market in 2015. The firm states in a recent report that these prominent vendors, including Cargill., BASF, Novozymes, DuPont, and Archer Daniels Midland, have focused largely on expanding their global footprint, mergers and acquisitions, and diversifying product portfolios. The January 2016 inauguration of a new $100 mn worth corn milling plant in Davangere, India, by Cargill is an instance of the several expansion strategies that the companies in the market are pursuing to strengthen their positions in the highly competitive global market. Entry barriers in developing regional markets are relatively less intense and competition is moderate. Developed countries such as the US feature fragmented markets and the presence of several companies operating amid intense competition. The vast environment-related benefits linked with the use of white biotechnology products across a number of application areas has led to the increased focus on the field's development from industries as well as government bodies in the past few years. Most governments have either already allocated or are in the process of allocating substantial budgets for the implementation of white biotechnology technology in the industrial sector. Focus has also improved on attempts for increasing the production of biofuel, one of the most notable products of the field of white biotechnology, with the aim of reducing dependence on oil and gas imports, especially in countries with no or very sparse oil reserves. Strict emission norms are also compelling industries to adopt white biotechnology across an increasing number of application areas. These factors are expected to have a significant impact on the overall development of the global white biotechnology market in the next few years. At the same time, the market is also expected to benefit from rapid technological developments in the field of production of white biotechnology products, making them cheaper and competitively priced as compared to conventional alternatives, such as, for instance, fossil fuels. To exploit the opportunity of the rising demand for bio-crops to its fullest, the trend of increased usage of fertilizers and pesticides with the view of improving yield has gained prominence in the past few years. The irresponsible use of fertilizers has stripped agricultural lands of their fertility to a huge extent. This issue is expected to have a direct impact on the overall production of bio-crops, the central determinants of the overall development of the white biotechnology market, hindering the overall growth prospects of the global market to a large extent. Nevertheless, the fact that less productive lands could be used for the production of biofuel crops will enable the market get sustained gains in the next few years. See Also: Expert Opinion - GS Krishnan - Novozymes Among the key product varieties available in the global white biotechnology market, the segment of biofuel dominated, accounting for a significant 38.16% share in 2015. The segments of biochemical and biomaterial held nearly 30% and 18% share in the global market, respectively, in the same year. Geography-wise, North America stood as a leading market, accounting for a share of over 35% in the global market in terms of revenue. In terms of application, the energy industry emerged the one with the most promising returns and accounted for a share of nearly 33% share in the market's overall revenues in 2015. ]]> <![CDATA[Vyome Biosciences Closes $14 Million Series C Financing]]> https://biospectrumindia.com/news/95/8400/vyome-biosciences-closes-14-million-series-c-financing.html https://biospectrumindia.com/news/95/8400/vyome-biosciences-closes-14-million-series-c-financing.html Tue, 23 Aug 2016 13:12:10 +0530 Vyome Biosciences, a clinical-stage specialty biopharmaceutical company developing novel medicines for treating skin diseases caused by resistant microbes announced today that it has closed $14 million Series C financing round. This financing round was led by Perceptive Advisors, a leading New York-based life sciences fund and, Romulus Capital, a Boston-based venture capital firm, along with participation from existing investors including Kalaari Capital, Sabre Partners and Aarin Capital. "We are very excited to announce the closure of our Series C financing. The support from leading global and leading life investors and the continued support from our largest existing shareholders validates our Company's strategy, science and development programs. The Company will utilize these funds predominantly to advance the clinical development of its lead product, VB 1953 and will allow us to completion of important milestones of clinical results. In addition, the Company will continue to advance the development of other proprietary products pipeline in the preclinical stage", said Venkateswarlu Nelabhotla (N. Venkat), Co-Founder & CEO, Vyome Biosciences. "Vyome is well positioned as a clinical stage company with a rich pipeline to becoming a leader in antimicrobial resistance and treatment of skin infections with the new funding round. This influx of funding also validates our hypothesis that innovation-driven R&D can attract top global investors", remarked Dr. Shiladitya Sengupta, Co-Founder of Vyome and an assistant professor of medicine at Harvard Medical School. According to the American Academy of Dermatology, Acne represents the most common skin disease, affecting 85% of teenagers and affects 40-50 million people in the US. Approximately 40% of acne patients are suffering from antibiotic resistance. Physicians around the world have cited a large unmet need for new, improved topical therapy options, vis-Ã -vis the current available topical products. Vyome's VB 1953 targets this potential USD 2 Billion market of antibiotic resistant acne. VB 1953 had its IND (Investigational New Drug) application accepted by the US FDA recently, and the company will soon be initiating clinical studies in USA. Apart from lead program VB 1953, Vyome also has a deep pipeline of preclinical New Chemical Entities (NCEs), unique in their ability to resist the development of resistance based on its patented Dual Action Rational Therapeutics (DARTs) technology. In addition, Vyome has clinically proven antifungal products based on its breakthrough technology platform Molecular Replacement Therapy (MRT), for which Vyome is currently pursuing commercialization discussions globally. ]]> <![CDATA[Mega Merger: Pfizer buys Medivation for $14 billion]]> https://biospectrumindia.com/news/95/8401/mega-merger-pfizer-buys-medivation-for-14-billion.html https://biospectrumindia.com/news/95/8401/mega-merger-pfizer-buys-medivation-for-14-billion.html Tue, 23 Aug 2016 13:09:17 +0530 Pfizer Inc. and Medivation, Inc. have announced that they have entered into a definitive merger agreement under which Pfizer will acquire Medivation, a biopharmaceutical company focused on developing and commercializing small molecules for oncology, for $81.50 a share in cash for a total enterprise value of approximately $14 billion. Pfizer does not expect the transaction to impact its current 2016 financial guidance. "The proposed acquisition of Medivation is expected to immediately accelerate revenue growth and drive overall earnings growth potential for Pfizer," said Ian Read, chairman and chief executive officer, Pfizer. "The addition of Medivation will strengthen Pfizer's Innovative Health business and accelerate its pathway to a leadership position in oncology, one of our key focus areas, which we believe will drive greater growth and scale of that business over the long-term. This transaction is another example of how we are effectively deploying our capital to generate attractive returns and create shareholder value." Also read: What would BREXIT mean for Biotech? Medivation's portfolio includes XTANDI® (enzalutamide), an androgen receptor inhibitor that blocks multiple steps in the androgen receptor signaling pathway within the tumor cell. XTANDI is the leading novel hormone therapy in the United States today and generated approximately $2.2 billion in worldwide net sales over the past four quarters, as recorded by Astellas Pharma Inc., with whom Medivation entered an agreement in 2009 to develop XTANDI globally and commercialize jointly in the U.S. Since its approval for advanced metastatic prostate cancer by the U.S. Food and Drug Administration in 2012, XTANDI has treated 64,000 men to date in the U.S. alone. Medivation and Astellas have built a robust development program for XTANDI, including two Phase 3 studies in non-metastatic prostate cancer and another Phase 3 study in hormone-sensitive prostate cancer. It is also being further developed in Phase 2 studies for the potential treatment of advanced breast cancer and hepatocellular carcinoma. In addition, Medivation has a promising, wholly-owned, late-stage oncology pipeline, which includes two development-stage oncology assets, talazoparib and pidilizumab. Talazoparib, currently in a Phase 3 study for the treatment of BRCA-mutated breast cancer, has the potential to be a highly potent PARP inhibitor and could be efficacious across several additional tumors. Pidilizumab is an immuno-oncology (IO) asset being developed for diffuse large B-cell lymphoma and other hematologic malignancies and has the potential to be combined with IO therapies in Pfizer's portfolio. "We believe the combination with Pfizer is the right next step in our growth trajectory and is a testament to the passion and dedication by which the Medivation team has delivered on our mission to profoundly transform patients' lives through medically innovative therapies," said David Hung, M.D., founder, president and CEO of Medivation. "This compelling transaction will deliver significant and immediate value to our stockholders and provides new opportunities for our employees as part of a larger company. We believe that Pfizer is the ideal partner to extend the reach of our blockbuster XTANDI franchise and take our promising, late-stage assets - talazoparib and pidiluzimab - to their next stages of development so that they can be made available to patients as quickly as possible." Pfizer expects to finance the transaction with existing cash. Under the terms of the merger agreement, a subsidiary of Pfizer will commence a cash tender offer to purchase all of the outstanding shares of Medivation common stock for $81.50 per share, net to the seller in cash, without interest, subject to any required withholding of taxes. The closing of the tender offer is subject to customary closing conditions, including U.S. antitrust clearance and the tender of a majority of the outstanding shares of Medivation common stock. The merger agreement contemplates that Pfizer will acquire any shares of Medivation that are not tendered into the offer through a second-step merger, which will be completed promptly following the closing of the tender offer. Pfizer expects to complete the acquisition in the Third- or Fourth-Quarter 2016. Pfizer's financial advisors for the transaction were Guggenheim Securities and Centerview Partners, with Ropes & Gray LLP acting as its legal advisor. J.P. Morgan Securities and Evercore served as Medivation's financial advisors, while Cooley LLP and Wachtell, Lipton, Rosen & Katz served as its legal advisors. ]]> <![CDATA[India announces New Biosimilar Policy to tap $35 billion global market by 2020]]> https://biospectrumindia.com/news/95/8302/india-announces-new-biosimilar-policy-to-tap-35-billion-global-market-by-2020.html https://biospectrumindia.com/news/95/8302/india-announces-new-biosimilar-policy-to-tap-35-billion-global-market-by-2020.html Mon, 22 Aug 2016 13:07:08 +0530 The Narendra Modi government has announced another major initiative to help the biotech industry by formulating the revised guidelines for biosimilars that has become effective from August 15, 2016. The new biosimilars policy, called the "Guidelines on Similar Biologics" prepared by Central Drugs Standard Control Organization (CDSCO) and the Department of Biotechnology (DBT), has been notified by DBT on August 18, 2016. The Guidelines were prepared jointly by the members of a taskforce set up by CDSCO and sub-committee of the Review Committee on Genetic Manipulation (RCGM). The guidelines of 2012 were revised through a consultative process with various stakeholders led by members of ABLE (Association of Biotechnology Led Enterprises), other industry associations, leading scientific institutions and labs and through the public review process. "Although case-by-case examination is important, these guidelines provide the required clarity and essentiality of data requirements for providing the similarity, physico-chemical characterization, preclinical structures and clinical trials," said Dr K VijayRaghavan, Secretary, Department of Biotechnology (DBT), Government of India. How will the guidelines help the biotech industry? "I expect to see a surge in Indian companies developing Biosimilars. This will lead to a large global opportunity along the lines of generic drugs where India can attain leadership," said an optimistic Dr Kiran Mazumdar Shaw, Honorary Chairperson of ABLE and CMD, Biocon. She has been a key member of the CDSCO task force that deliberated for over a year and finalized the guidelines at a meeting in New Delhi on 6th August 2016. According to a Special Report on Biosimilars prepared by Invest India, under the Department of Industrial Promotion and Policy (DIPP), the global market for biological drugs will touch the $290 billion mark in 2020 and account for 27 per cent of the pharma sales. In that the biosimilars will be a $25-35 billion opportunity by 2020. Also read: Global Bioinformatics market to touch $30.87 bn by 2020 Currently, 450 biosimilars have been approved globally and another 250 are in the pipeline. Added Dr G N Singh, the Drug Controller General of India (DCGI): "These revised guidelines will go a long way in providing guidance and documentation support to both applicants and regulators for the development, approval and post-marketing evaluation of safety and efficacy of similar biologics in the country and provide access to affordable biotherapeutics to the patients across the globe." The guidelines provide the regulatory pathway for a Similar Biologic claiming to be Similar to an already authorized Reference Biologic. These guidelines are for the guidance of all stakeholders and are not meant to substitute or rephrase the Rules made under Drugs and Cosmetics Act, 1940 or any other relevant Acts and are subject to being in conformity with the Drugs and Cosmetics Act and Rules as may be amended from time to time. Here are some of the key changes that have been incorporated in the revised biosimilars guidelines. Ã˜ If the reference biologic (for which the biosimilar is being developed) is not marketed in India, the reference biologic can be licensed in any ICH country (i.e. EU, Japan, US, Canada and Switzerland) Ã˜ CDSCO is calling for specific post marketing safety data "through a predefined single arm study of generally, more than 200 evaluable patients and compared to historical data of the Reference product. The study should be completed preferably within 2 years of the marketing permission/manufacturing license unless otherwise justified." Ã˜ CDSCO added primary endpoint should be safety (Phase IV), while secondary endpoint should be safety and immunogenicity. Ã˜ "If immunogenicity is evaluated in clinical studies, it is not mandatory to carry out additional non comparative immunogenicity studies in post marketing studies Ã˜ "If the firm conducts preapproval studies that included more than 100 patients on the proposed Similar Biologic drug, the number of patients in phase IV study can be reduced accordingly so that the safety data (from both Phase III and IV) is derived from a minimum of 300 patients treated with Similar Biologics." If a product is found to be similar "in preclinical, in vitro characterization having established PK [pharmacokinetic] methods and a PD [pharmacodynamics] marker that is surrogate of efficacy, the residual risk is significantly reduced in the Phase I study if equivalence is demonstrated for both PK and PD. Phase III clinical trials of such a Similar Biologics product may be waived...[and] where considered necessary, an appropriate single arm study in at least 100 evaluable subjects may be carried out in the most sensitive indication to address any residual uncertainty." Ã˜ "In case the safety and efficacy study is waived all the indications approved for reference product may be granted based on comparable quality, non?clinical as well as convincing PK/PD data. Wherever the phase III trial is waived, the immunogenicity should have been gathered in the PK/PD study and will also need to be generated during post approval Phase IV study. Some of the other highlights are:Reference Biologic § These guidelines apply to Similar Biologics that contain well characterized proteins as their active substance, derived through modern biotechnological methods such as use of recombinant DNA technology. The demonstration of similarity depends upon detailed and comprehensive product characterization, preclinical and clinical studies carried out in comparison with a Reference Biologic. § Similar Biologics can only be developed against the Reference Biologic that has been approved using a complete data package in India. In case the Reference Biologic is not authorized in India, it should have been approved / licensed and marketed in an ICH (The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use) country. § Any product can be considered as a Similar Biologic, only if it is proven to be Similar using extensive quality characterization against the Reference Biologic. Further product development should only be considered once the similarity of the Similar Biologic is demonstrated in quality to a Reference Biologic. § These guidelines are applicable for Similar Biologics to be developed in India or imported into the country for marketing authorization. Detailed regulatory pathways for indigenously developed and imported products are mentioned under Annexure 1. Manufacturing § The Similar Biologics manufacturer should develop the manufacturing process to yield a comparable quality product in terms of identity, purity and potency to the Reference Biologic. § If the host cell line used for the production of Reference Biologic is disclosed, it is desired to use the same host cell line for manufacturing Similar Biologics. Alternatively any cell line that is adequately characterized and appropriate for intended use can be used to develop a Similar Biologic, with appropriate justification in order to minimize the potential for signi?cant changes in quality attributes (QAs) of the product and to avoid introduction of certain types of process related impurities that could impact clinical outcomes and immunogenicity. For the establishment and characterization of the cell banks, the guidelines issued by the ICH should be referred for guidance. § The data requirements for review of manufacturing process at preclinical submission stage include a complete description of the manufacturing process from development and characterization of cell banks, stability of clone, cell culture/ fermentation, harvest, excipients, formulation, purification, primary packaging interactions (if different from Reference Biologic), etc. and the consequences on product characteristics. Preclinical § The applicant has to comply with the RCGM requirements like demonstration of consistency of the process and product, product characterization and product specifications. The applicant should submit the data generated along with basic clinical information and preclinical study protocols to RCGM for obtaining permission. The toxicology studies should be initiated after the approval of RCGM. § The application to RCGM should be accompanied by approval of Institutional Biosafety Committee (IBSC) of the developer (copy of the minutes should be submitted), and approval of Institutional Animal Ethics Committee (IAEC), if available. The applicant should also provide details of the proposed site for conduct of toxicity testing and personnel to be involved e.g. study director, principal investigator, pathologist, other Investigators and quality assurance officer at the site. Status of GLP certification of proposed facility should also be provided. Clinical Trial Application Besides the information submitted in the preclinical application, the applicant has to submit application for conduct of clinical trial as per the CDSCO guidance for industry, 2008. The quality data submitted should indicate that there are no di?erences in Critical Quality Attributes (CQAs), and that all Key Quality Attributes (KQAs) are well controlled in order to allow the initiation of clinical evaluation. Post-Market Data for Similar Biologics It is important to establish a formal Risk Management Plan to monitor and detect both known inherent safety concerns and potential unknown safety signals that may arise from the Similar Biologic since authorization is based on a reduced preclinical and clinical data package. The risk management plan should consist of Pharmacovigilance Plan, Adverse Drug Reaction (ADR) Reporting, and Post Marketing Studies (Phase IV Study). Source: ABLE ]]> <![CDATA[India's healthcare expenditure lowest in the world: KPMG]]> https://biospectrumindia.com/news/95/8399/indias-healthcare-expenditure-lowest-in-the-world-kpmg.html https://biospectrumindia.com/news/95/8399/indias-healthcare-expenditure-lowest-in-the-world-kpmg.html Mon, 22 Aug 2016 13:01:12 +0530 Non-communicable diseases (NCDs) account for nearly 60 percent of deaths in India annually. The country is estimated to lose $4.58 trillion by 2030 due to them. India clearly faces a large and looming economic and wellness burden and prioritising healthcare has never been more critical. It is imperative that all stakeholders collaborate and increase their commitment towards a patient-centric healthcare ecosystem. The 'KPMG - OPPI background paper on healthcare access initiatives' presents the current healthcare scenario in India and the future burden should there be a further delay in access initiatives; it also summarizes the various interventions undertaken by member companies of the Organization of Pharmaceutical Producers of India (OPPI) in this regard. Also read: Global Bioinformatics market to touch $30.87 bn by 2020 The background paper highlights worrying statistics and insights into the Indian Healthcare system: â€¢ Poor Healthcare Indices - Life expectancy in India (68 years in 2015) is amongst the lowest in BRIC nations â€¢ Inadequate healthcare infrastructure - Number of hospital beds per 1,000 population of 0.9, lowest among BRIC nations. Seventy-five percent of dispensaries and 60 percent of hospitals are in the urban areas â€¢ Need for more trained human resources - Lowest number of physicians per 10,000 population among BRIC. Eighty percent of doctors are in the urban areas serving only 28 percent of the population â€¢ Poor availability - In rural India, only 37 percent of people have access to In-Patient Department (IPD) facilities within a 5 km distance; and only 68 percent have access to an Out-Patient Department (OPD) â€¢ Burdened care - Nearly 63 million people are in debt due to health expenditure â€¢ Poor insurance coverage - Nearly 75 percent of population uncovered. Out-of-pocket (OOP) contributes close to 86 percent of private and 60 percent of overall healthcare expenditure. India spends less on healthcare than most other middle income countries Commenting on this immediate need of the hour, Mr Utkarsh Palnitkar, Partner and Head, Infrastructure, Government, Healthcare and Life Sciences, KPMG India, said, "While the Government of India plays a laudable role in providing healthcare, human life lost due to lack of awareness is staggering! Often, disease detection is so delayed that neither access nor affordability can play any role. Only a long-term, proactive strategy with education and awareness at its centre, involving all stakeholders, that is, healthcare providers, insurance companies and healthcare and pharmaceutical companies, can achieve the desired vision of a healthy country." See Also: Utkarsh Palnitkar joins KPMG India as Head - Life sciences practice India has also not been able to meet most of the health targets under the Millennium Development Goals (MDGs), defined by the UN Summit in 2000. Dr Shailesh Ayyangar, President, OPPI, talks about healthcare for all. He says, "Universal Healthcare is a social priority. It aims to powerfully enhance the health of people and its rewards go well beyond health. India's healthcare strategy requires a holistic approach and a critical evaluation of our existing systems. "We need sustainable policy solutions to address healthcare financing, infrastructure and human resource challenges." ]]> <![CDATA[What would BREXIT mean for Biotech?]]> https://biospectrumindia.com/features/95/1804/what-would-brexit-mean-for-biotech.html https://biospectrumindia.com/features/95/1804/what-would-brexit-mean-for-biotech.html Mon, 22 Aug 2016 12:59:25 +0530 Britain's exit from the European Union (EU) has shaken the world economy. There is an uncertainty in the business world across sectors, and biotech is no different. Britain is a very important market for biotech and pharma, and one of the immediate challenges is the fate of the European Medicines Agency (EMA) among others. As per a Norton Rose Fulbright, a global law firm, "After Brexit (2018+) the impact upon the life sciences and healthcare sector largely depends upon what model the UK adopts for its relationship with the EU. If the UK remains in the European Economic Area (EEA), then the changes may be minimal. If the UK joins the European Free Trade Association (EFTA) and negotiates sector specific access to the single market, then the landscape depends on the exact nature of that relationship. If the UK distances itself further from the EU, then the changes may be more extensive. Whatever the relationship ultimately is, the UK has a strong track record in the life sciences and healthcare sector with tax incentives, investment and funding, R&D and other key drivers high on its agenda. We would expect that to continue. The UK accounts for approximately 25% of the EU market and will remain a key market. Switzerland (which is not in the EU) is a prime example of how the sector can develop effectively outside of the EU." We contacted industry captains, to understand their views on BREXIT, and whether it will have any impact on Indian lifescience, pharma and biotech sector. Here's what they have to say: "We respect the democratic decision reached in this referendum. We expect that there will now be a protracted period of transition and we will engage with all the relevant stakeholders to safeguard the competitiveness of the life science industry and the speed of patient access to innovative medicines. We also expect that there will be a period of intense negotiations to determine how the UK will work with Europe and the rest of the world and this could take several years to complete. We therefore believe that the effects of BREXIT will not be immediate and it is too early to discuss its impact on the industry."- Sanjay Murdeshwar, Managing Director, AstraZeneca India Also read: Global Bioinformatics market to touch $30.87 bn by 2020 "BREXIT is likely to have an impact on the pharmaceutical industry which includes life sciences and the biotech sectors. Membership of the EU has meant that Britain had tariff free access to the EU the second largest economy in the world. The majority of Britain's exports are to the EU. There is expected to be a sizeable impact on scientific research in the UK including clinical research. While Britain contributes money to the EU to fund science and technology research it also gets back a significant amount by way of grants for R&D. In fact of the 28 countries that form part of the EU it receives the highest grants towards research after Germany. The decline in the value of the amount is likely to have immediate impact on Indian companies that have an exposure to the UK market. Many existing contracts of pharmaceutical companies with manufacturing and R&D will be losing propositions unless these are renegotiated. However, there is an opportunity to strengthen India - UK economic ties given the long history of these two nations. One of the immediate challenges as a result of BREXIT is the fate of the European Medicines Agency (EMA) itself which is currently located in London and oversees drug regulation and approval for all EU nations. If it comes to a stage where EMA has no jurisdiction over Britain then pharmaceutical companies in UK would need to get approval in both the UK and the EU translating into more time and energy to get drug approvals and bring new medicines to patients in these countries. BREXIT puts under jeopardy the ability of pharmaceutical companies in Britain to access the large pool of patients in the EU market not only for its drugs but also for clinical trials. The EU is estimated to have around 500 million patients."- Ranjit Shahani, President Emeritus, OPPI "It would not mean anything for bioscience industry, unless other members of EU also start exiting EU.As for Indian pharma/lifesciences/biotech sector, nothing foreseen, except a minor blip for some companies that have UK as a major market. We have to wait and watch. It's too early to comment." -Dr. K.R. Rajyashri, Director & CSO, Navya Biologicals ]]> <![CDATA[Exploring the next decade of Indian innovation]]> https://biospectrumindia.com/news/95/7665/exploring-the-next-decade-of-indian-innovation.html https://biospectrumindia.com/news/95/7665/exploring-the-next-decade-of-indian-innovation.html Mon, 22 Aug 2016 12:58:14 +0530 Attended by over 100 leading corporate leaders, government representatives and the media, the India Innovation Dialogue provided the platform for innovation leaders to deliberate on 'Exploring the next decade of Indian Innovation.' Mr Lars Sorensen, President and CEO, Novo Nordisk; Mr Rakesh Mittal, Vice President, CII & Vice-Chairman, Bharti Enterprises; Mr T V Narendran, MD, Tata Steel; and Mr Bhasker V Iyer, Non-Executive Director, Abbott India, were among the notable attendees. The roundtable was moderated by Mr Ajoy Kumar, ex-member of Parliament. The roundtable saw participation from leading policy makers, global CEOs, experts in social and grassroots innovation, and well known economists. The panellists engaged in insightful discussions on possibilities of improving industrial innovation landscape for sustainable value creation in India over the coming decade, commercialization of grass-root innovations, facilitating start-ups, strategies to impact innovation, and how to leverage strength of networking with government, industry, institutions and academia. See Also: Major players in Type 2 Diabetes shifting focus to pricing to maintain market share Mr Sorensen, who was one of the panellists said, "India is a great land of innovation and ingenuity. As industry leaders, we have the means and resources to develop ideas into action for the betterment of the society. This is what innovation is. But innovation simply cannot sustain on dreams alone, a commitment too is required. For us at Novo Nordisk, innovation is in the foundation of our existence and it is what drives us to help people with diabetes lead normal life and pursue their dreams. We do this by forging a partnership with the various stakeholders to work together to defeat diabetes. In India, the Novo Nordisk Education Foundation too is collaborating with several state governments and organizations in order to reach out to people to enhance awareness and train healthcare professionals." In last two years, the government of India has been very proactive to roll out many initiatives and schemes which directly affects the innovation and start-up ecosystem in the country, and if implemented successfully these schemes will provide long term benefits to the economy. Several important initiatives like Make in India, Start-up India and Skill India will promote a healthy environment for the growth of Innovation in the country. The Government of India has also recently announced radical liberalization of the Foreign Direct Investment (FDI) regime by easing norms for a host of important sectors including defence, civil aviation and pharmaceuticals, opening them up for complete foreign ownership. With these measures and many others in place India is gradually becoming one of the most attractive innovation destinations for foreign investors. Representing the industry Mr Mittal said "The only choice for the survival of Indian industry is to re-imagine Indian innovation. India needs to boost its innovation ecosystem, which is only possible if we contribute our part in this journey." Another leading voice from the Industry Mr T V Narendran said "We cannot work in isolation, and all stakeholders must come and work together to achieve success in the long run." From World Intellectual Property Organization (WIPO) Dr Sacha Vincent said: "Innovation is in the Indian DNA. While world economy is slowing down, India's position is positive and their global innovation index ranking has improved." ]]> <![CDATA[DPCO: A nightmare for Pharma firms? ]]> https://biospectrumindia.com/features/95/7663/dpco-a-nightmare-for-pharma-firms-.html https://biospectrumindia.com/features/95/7663/dpco-a-nightmare-for-pharma-firms-.html Mon, 22 Aug 2016 12:57:49 +0530 In order to make drugs more affordable and accessible to patients, National Pharmaceutical Pricing Authority (NPPA) has capped the price of the (essential) drugs, which has sent pharma sector in a turmoil, most of the pharma companies have witnessed a hit on their profit margins. DPCO impact on Pharma SectorThe NLEM (National List of Essential Medicines) list has been expanded since DPCO 2013 with amended DPCO in March 2016 taking total notified formulation to 820 from earlier 628. NPPA has fixed ceiling price for 530 of these in March 2016 with overall ~12% of industry coming under price control as on date. This has resulted in incremental impact for the industry as indicated in slowing growth over last 3 months (accentuated by ban on FDC drugs). The volumes for DPCO covered drugs has been on a declining trend while overall drug volumes in the market has been increasing. "DPCO 2013 had a considerable impact on domestic business of Indian Pharmaceutical industry with industry growth (in MAT terms) reducing to low single digits in FY2014 from mid double digits earlier. Along with cut in drug prices, it also resulted in trade related issues further impacting overall supply chain. The industry, though, has recovered over last two fiscals with domestic MAT growth at 12-13% in FY2015 and FY2016. The recovery has been driven by volume and price growth in non DPCO portfolio and WPI linked price growth in DPCO portfolio. Pharma companies have launched new products including non DPCO combinations to protect their margins along with increased penetration to support growth," said Mr Subrata Ray, ICRA India, Sr. Group Vice President, ICRA Limited. Also read: Industry Report on PM's Africa Visit IMS Health report, 'Assessing the Impact of Price Control Measures on Access to Medicines in India' mentions that DPCO has an impact on the tail-end brands than the leading players thereby increasing market concentration and resulting in discontinuation of brands, with average number of brands in DPCO molecules reducing from 36 in 2013 to 32 in 2015. These market forces can move towards strengthening of oligopolistic behaviour, which will result in reduced set of choices for the doctors/patients. The report further stated that Price control and unstable regulatory environment has increased the margin pressures for companies, thereby impacting their sustainability especially small and midsized players. This further impacts the employment generation potential of the industry. These factors dampen the sentiments across the industry and potential domestic and international investors. The move have also impacted our export growth, as per the IMS Health report Post 2013, while the volumes grew at 9%, value growth was significantly lesser at 5%. India's pharma exports to other developing countries accounts for ~12% of our total exports of pharmaceuticals. PPP wise price comparison against these countries indicates that average prices of Indian drugs is lower than the prices in these countries. These countries could benchmark their prices against domestic Indian prices and negatively impact our growing exports market. R&D slump? DPCO would impact the R&D development for pharma firms, most notably innovation driven biopharmaceutical firms in India. DPCO might inhibit the R&D companies to significantly invest in development of drugs which might come under DPCO scanner in future and affect scale ups, expansions and the international quality. "This is because curbing the price of a drug which has the market potential to be priced higher, affects the entire business plan for its development and lowers the returns on investments made for that drug, making the entire project financially infeasible, causing rejection," explains Mr N Venkat, co-founder and CEO, Vyome Biosciences. Decline in R&D resulting in fewer new introductions of generic products; Post DPCO 2013, the average number of new introductions in DPCO molecules has declined, which also indicates increasing concentration and reducing competitive intensity, the IMS Health report stated. "From last six months hardly new formulations has introduced in domestic market. Even MNCs are not planning to introduce any new therapy in our country due to lack of proper drug and pricing policies," said Dr Sanjay Agarwal, Pharmaceuticals Consultant. However, Mr Ray feels DPCO may not directly impact R&D. He explains, "The R&D budget of domestic pharma companies are largely export focused and same has actually increased considerable over last few years. While, DPCO does not have a direct impact on R&D/ investments by the industry however significant expansion of the scope of NLEM, may potentially impact the profitability of domestic business - this in turn may limit the ability of Indian Pharma to generate cash surplus for quality/ R&D investments." It will also have impact on marketing budget of these specific drugs. It is potentially possible that both marketing budget and R&D budget will take hit. The impact varies from company to company based on the allocation of available funds. Making Drugs affordableSome reports suggest that many companies have cut down on manufacturing of (essential) drugs, which in turn deflects the purpose of price control. According to IMS Health report, for low-income households that are reliant on the government system for healthcare, DPCO would not improve the patient's ability to purchase drugs. This is supported by the fact that no significant penetration of price controlled molecules in rural markets is visible, with consumption in rural towns decreasing at ~7% over the last 2 years. The price controlled molecules has also witnessed muted growth in prescriptions outside metros (town class I) as compared to 5% Rx growth in non-DPCO molecules. What could be the alternative of making drugs affordable and accessible while ensuring pharma firms remain interested in manufacturing these (essential) drugs and profitable? "Bringing the notional loss due to curb on pricing under CSR programs in addition to the required contributions and asking for companies' commitment to provide pre-defined quantities of drugs per year to patients while simultaneously providing them benefit of CSR contribution," suggests Mr Venkat. He further recommends a three-way arrangement between NPPA, Drug Manufacturers and Insurance Companies whereby the drugs under DPCO to be covered under insurance plans reimbursement partially up to a minimum limit before imposing DPCO. This will not only improve profitability of the manufacturers, but will also increase the insurance cover in India. Other benefits like Income tax exemptions on profits made on essential drugs, can be explored. "With India's enormous population, one of the biggest hurdles that we face is access to quality healthcare for all our citizens. Contrary to popular belief, price control has limited impact on improving patient access to medicines. A good place to begin is to prioritize healthcare and enhance public expenditure towards it. Additionally, there is a need for increased focus on infrastructure and capacity building. A viable public healthcare model requires a combination of financing and non-financing measures," suggests Dr Shailesh Ayyangar, President, OPPI and Managing Director - Sanofi India. DPCO may not be a nuisance for pharma companies if rolled out with clear provisions and also incorporating some changes and extending some benefits to companies which take into account the profitability of the companies, especially for those companies which are involved in innovation driven work. "DPCO should improve patients' access to essential medicine, but should also incentivize the pharma companies to invest in innovation, quality and expansion," Mr Venkat concluded. ]]> <![CDATA[Awareness, Capacity building and Treatment on NCDs is the need of the hour]]> https://biospectrumindia.com/news/95/8256/awareness-capacity-building-and-treatment-on-ncds-is-the-need-of-the-hour.html https://biospectrumindia.com/news/95/8256/awareness-capacity-building-and-treatment-on-ncds-is-the-need-of-the-hour.html Fri, 19 Aug 2016 15:48:25 +0530 The Organisation of Pharmaceutical Producers of India (OPPI) hosted its Fifth Healthcare Access Summit today, supported by the Ministry of Health and Family Welfare, and the Department of Pharmaceuticals, Ministry of Chemicals and Fertilisers. The theme of the summit was ACT (Awareness, Capacity building and Treatment) on Non-Communicable Diseases, (NCDs); discussions centered around addressing the fast-growing risk of NCDs and measures to contain this disease burden. The Summit brought together government officials, policy-makers, leaders from the healthcare and pharmaceutical industries, global healthcare experts and other distinguished professionals. Participants discussed diverse aspects of tackling the NCD challenges and potential solutions, at a day-long event. Also read: Lupin, Sun Pharma, Cipla and Dr. Reddy's Laboratories top India's Most Reputed Pharmaceutical list This attention to NCDs is being structured on four grounds: the scale of the challenge, the World Health Organisation's (WHO) Global Action Plan to contain NCDs, the need for a strengthened patient centric healthcare system and a roadmap in the form of a Declaration, at the Access Summit. First: Over the past decades, rising income levels and increased life expectancies have been a feature of Indian economic and demographic growth. NCDs pose a huge challenge to the country's healthcare system. NCDs, including cardio-vascular diseases, cancer, diabetes, and chronic lung diseases, account for more than half the deaths in India. Today, India is being referred to as the 'diabetes capital of the world.' Addressing the summit, Mr Lars Rebien SÃ¸rensen, President and Chief Executive Officer Executive, Novo Nordisk said "Diabetes is a global challenge. Through this summit, we are looking forward to engaging with all the stakeholders in the fight against diabetes. As an industry, we should collaborate with likeminded stakeholders in order to identify the best interventions, the most optimal healthcare responses and to ensure people with diabetes have access to the right treatment at the right time in the right way." Speaking at the Summit, cricketing hero, Sachin Tendulkar, Changing Diabetes® Brand Ambassador for Novo Nordisk said, "The diabetes pandemic is a cause for concern in India and around the world. It is an enormous public health challenge that calls for countries of the world to unite together with polices aimed at curbing the disease. Changing Diabetes movement in India pioneered by Novo Nordisk has been instrumental in creating awareness about the disease and timely intervention. Let's control it before it controls us." Second: In line with WHO's Global action plan for the prevention and control of NCDs 2013-2020, India is the first country to develop specific national targets and indicators aimed at reducing the number of global premature deaths from NCDs by 25% by 2025. Dr Shailesh Ayyangar, President, OPPI, and Managing Director, India & Vice President, Sanofi India said, "Indeed, we have many healthcare challenges in our country, but we also are very proud that many healthcare indices look much better today, as compared with 50 years ago. We have successfully won the battles against dreaded leprosy and polio. However, NCDs are emerging as a grave public health concern. It would need collective will and commitment of all stakeholders to work collaboratively to halt the onslaught of NCDs. OPPI member companies have been working closely with Government and other stakeholders in the herculean task of enhancing awareness about NCDs and engaging in patient education and support programmes to ensure better patient outcomes." Third: Reiterating the importance of the patient at the core of all activities, the 'KPMG-OPPI report on healthcare access initiatives' was released at the Summit. The report presents the current healthcare scenario in India, and the potential future burden should there be a further delay in implementing access initiatives. It also summarises the various interventions undertaken by OPPI member companies towards improving patient access to healthcare. Kanchana TK, Director General, OPPI said, "Our healthcare system should be patient-centric. An integrated patient-oriented approach, combined with a universal chronic disease management framework is imperative. We need to ACT now on NCDs. Restructuring and strengthening healthcare systems have resulted in a decline in the incidence of infectious disease. This provides adequate evidence that the same result is possible for NCDs. Our members fully support Government's endeavour and initiatives in containing this disease burden, and look forward to working with them to accomplish India's NCD reduction goals set for 2025." Fourth: The Delhi Declaration on Non-Communicable Diseases was announced by renowned endocrinologist Dr Shanshank Joshi, at the Summit. The Declaration articulates the intention of reducing the burden of NCDs though innovative and sustainable solutions that decrease the social, economic and medical burden of NCDs. Additionally, the Declaration seeks to achieve the set NCDs and UN's Sustainable Development Goals (SDGs) 3.4 goals and outlines direct actions that can be undertaken to combat NCDs in India. More importantly, it serves as an inspiration across all the states of India and the wider region. At this summit, OPPI also recognised Aravind Eye Care Systems with the OPPI Healthcare Access Award 2016; The Cancer Institute (WIA), Adyar, Chennai, with the OPPI Healthcare Access Award on NCDs and Dr V. Mohan, Dr Mohan's Diabetes Specialties Centre with the OPPI Award for Improving Access to Diabetes Care. ]]> <![CDATA[Lupin, Sun Pharma, Cipla and Dr.Reddy's Laboratories top India's Most Reputed Pharmaceutical list]]> https://biospectrumindia.com/news/95/8489/lupin-sun-pharma-cipla-and-dr-reddys-laboratories-top-indias-most-reputed-pharmaceutical-list.html https://biospectrumindia.com/news/95/8489/lupin-sun-pharma-cipla-and-dr-reddys-laboratories-top-indias-most-reputed-pharmaceutical-list.html Thu, 18 Aug 2016 11:58:10 +0530 Mumbai based Lupin Pharmaceuticals tops in Reputation in the Pharmaceutical sector leading India's Most Reputed Pharmaceutical Brands list. Sun Pharma is the second Most Reputed Brand with a 52% lower Brand Rep Score and Cipla is at 3rd position with a Brand Rep Score 28% behind the previous ranked. At India's fourth Most Reputed Pharma Brand is Dr.Reddy's behind 71% in terms of Brand Rep points. Among global brands GSK leads the way followed by Pfizer with a Brand Rep Score 73% below the leader among International pharmaceutical companies. Abbott's Brand Rep Score was 12% lower, ranking it India's 3rd Most Reputed among International brands. There were 41 Domestic and 17 International pharmaceutical brands listed in the study by BlueBytes conducted in association with TRA Research (both part of the Comniscient Group) which released 'India's Most Reputed Pharmaceutical Brands 2016'. This report is the second in the India's Most Reputed Brands series, and the company is set to launch a report each month covering different sectors. The study evaluates brand's Brand Reputation by analyzing media perception and consumer perceptions. Also read: Cuddle for Imports, Hurdles for Exports "India's Reputation as the largest producer of generic drugs in the world has become vulnerable in light of the changing patent regime in the country. Reports say that by 2020, India is likely to be among the top three pharmaceutical markets by incremental growth and sixth largest market globally in absolute size. Reputation is defined as a measure of the effectiveness of transmitted belief about attitudes showcasing Respect - and our report measures the consumer Respect for a brand and also its transmission by measuring the media quotient. Given the importance of this sector for the economy and to the public, brands should concentrate on building and maintaining their Reputation to stay ahead in the changing world," said Pooja Kaura, Chief Spokesperson for India's Most Reputed Brands. India's Most Reputed Pharmaceutical Brands was a study conducted within the Pharmaceutical industry with BlueBytes analyzing news of 58 pharma brands in all the major English and Hindi print media (newspapers and magazines) across 9 cities as a representative of the news across all media. A total of 24,414 articles pharma news were analyzed between July 15, 2015, and July 16, 2016. In addition to news analysis, the consumer's perception was also studied and this part of the analysis was contributed by TRA Research, which interviewed 2,500 consumer-influencers on the aspect of Respect. The 60-page, soft-bounded report is available for Rs. 999/-. ]]> <![CDATA[Venous Thromboembolism therapeutics market set to hit $3.7 bn by 2025]]> https://biospectrumindia.com/features/95/8337/venous-thromboembolism-therapeutics-market-set-to-hit-3-7-bn-by-2025.html https://biospectrumindia.com/features/95/8337/venous-thromboembolism-therapeutics-market-set-to-hit-3-7-bn-by-2025.html Thu, 18 Aug 2016 10:44:59 +0530 The therapeutics market for venous thromboembolism (VTE), a condition which comprises deep vein thrombosis and pulmonary embolism, is set to rise from $2.8 billion in 2015 to $3.7 billion by 2025, representing a Compound Annual Growth Rate (CAGR) of 2.89%, according to research and consulting firm GlobalData. The company's latest report states that this steady growth, which will occur across the seven major markets of the US, France, Germany, Italy, Spain, the UK, and Japan, will be driven primarily by the rise in sales surrounding the VTE primary prophylaxis space, which is projected to increase from $2.4 billion in 2015 to $3.5 billion by 2025, at a CAGR of 4.01%. Also read: Novel lipid altering therapies to steer acute coronary syndrome market beyond $12 bn by 2022 Dr Michela McMullan, GlobalData's Analyst covering Cardiovascular and Metabolic Disorders, explains: "Novel oral anticoagulants (NOACs), which are used to prevent and treat VTE, will primarily drive the market, and represent important advances over warfarin, a cheap and established anticoagulant. "This is because NOACs do not require routine blood monitoring or dose adjustments, have fewer drug-drug interactions, do not produce major dietary effects, and in terms of efficacy and safety, have been proven to be non-inferior, if not superior, compared with warfarin." GlobalData believes that as physician familiarity with these drugs increases, and experience is gained in selecting the appropriate NOAC dependent on a patient's risk profile, further NOAC uptake will occur across all markets. Indeed, Pradaxa, Xarelto, and Eliquis, which are all currently available, will see improved uptake over the forecast period. In addition, the recent launch of a fourth NOAC, Savaysa, in the US and Japan will give physicians further treatment options when deciding on which anticoagulant is most suitable for their patients, and is also expected to impact overall NOAC uptake. See Also: Novel lipid altering therapies to steer acute coronary syndrome market beyond $12 bn by 2022 Dr McMullan continues: "Despite the benefits that NOACs will bring to the VTE market, the treatment space still requires a transformational therapy to push its growth rate up beyond current levels. In order to develop a drug that offers transformational changes in terms of safety instead of incremental benefits, focus would need to be turned towards better renal function and optimal care for cancer patients. "A drug with a superior renal clearance profile could command premium pricing in this market and would be accepted more easily. The ideal drug should be oral, have a once-a-day dosing, should not depend on monitoring, and should be usable for patients in all stages of renal impairment." ]]> <![CDATA[Piramal to acquire Ash Stevens for $43 Mn]]> https://biospectrumindia.com/news/95/8479/piramal-to-acquire-ash-stevens-for-43-mn.html https://biospectrumindia.com/news/95/8479/piramal-to-acquire-ash-stevens-for-43-mn.html Tue, 16 Aug 2016 17:18:53 +0530 Piramal Enterprises announced today that its wholly-owned subsidiary in the US has entered into an agreement to acquire 100% stake in Ash Stevens., a US-based Contract Development and Manufacturing Organization (CDMO), in an all cash deal for a consideration of $42.95 million plus an earn-out consideration capped at $10 million. Located in Riverview, Michigan, Ash Stevens has over 50 years of experience in contract manufacturing, and serves several biotech, mid-size pharma, and large pharmaceutical clients worldwide. With over 60,000 sq. ft. of facilities, eight chemical drug development and production laboratories, and six full-scale production areas, Ash Stevens has built a stellar reputation, led by science, driven by operational excellence, and one that emphasizes quality as a culture. See Also: Piramal to acquire four brands from Pfizer As one of the leaders in HPAPI manufacture, Ash Stevens has an impeccable safety record of working with high potency anti-cancer agents and other highly potent therapeutics. The state-of-the-art manufacturing facility in Michigan features all necessary engineering and containment controls for the safe handling and cGMP manufacture of small and large-scale HPAPIs, with Occupational Exposure Limits (OELs) â‰¤ 0.1µg/m3. The facility has approvals from US, EU, Australia, Japan, Korea, and Mexican regulatory agencies. "The acquisition of Ash Stevens fits well with our strategy to build an asset platform that offers value to our partners and collaborators. Currently, around 25% of the molecules in clinical development are potent. Our clients are looking for reliable partners that can assist them in advancing these programs forward," said Mr Vivek Sharma, CEO of Piramal Pharma Solutions. He further adds, "North America is a key market that we can now service with our three local facilities - the Coldstream Labs in Kentucky for fill finish needs, the Torcan facility in Toronto for complex high value API's and now, Ash Stevens in Michigan for HPAPIs. Having facilities with a differentiated platform and geographical proximity to clients are keys towards building strategic partnerships. We expect this acquisition to also be synergistic with our Antibody Drug Conjugates (ADCs) and injectable business. We can now fulfill client requirements for a single source of supply for both high potent APIs and drug products." "With its rich history of scientific excellence, a track record of 12 product launches, Ash Stevens is well poised to become the partner of choice for clients looking to advance programs from early development through launch. In addition to the business benefits that the combined entity will bring to our clients, I am also pleased that the firms share common core values: both were founded by successful entrepreneurs, value integrity, and are committed to a customer-first approach", said Dr Mark Cassidy, President of the API Business at Piramal Pharma Solutions, "I am pleased to welcome the Ash Stevens team into the Piramal group. We expect them to be an integral part of our future growth plans." Added Dr Stephen Munk, CEO ,Ash Stevens, "We look forward to working with the Piramal leadership and management team, to develop API solutions that benefit customers and improve the lives of patients. The commitment that Piramal has shown towards growing its healthcare businesses, coupled with the complementary capabilities that our two firms have, makes this an exciting time for Ash Stevens and our employees. We have already identified areas where we can create significant value together, and will be moving forward rapidly to achieve those objectives." The transaction is not subject to any regulatory approvals. No related party of PEL has any interest in Ash Stevens. Wells Fargo Securities, LLC served as exclusive financial advisor to Ash Stevens, with legal counsel provided by Morrison & Foerster LLP. ]]> <![CDATA[Novel lipid altering therapies to steer acute coronary syndrome market beyond $12 bn by 2022]]> https://biospectrumindia.com/features/95/8288/novel-lipid-altering-therapies-to-steer-acute-coronary-syndrome-market-beyond-12-bn-by-2022.html https://biospectrumindia.com/features/95/8288/novel-lipid-altering-therapies-to-steer-acute-coronary-syndrome-market-beyond-12-bn-by-2022.html Tue, 16 Aug 2016 17:18:28 +0530 The launch of several new lipid targeting therapies which offer clinical effectiveness for statin intolerant patients and patients who require additional lowering of low-density lipoprotein C (LDL-C) in combination to statin therapy, will drive the ACS market, according to research and consulting firm GlobalData. The company's latest report states that this growth, which will occur across the seven major markets (7MM) of the US, France, Germany, Italy, Spain, the UK, and Japan, can be attributed to launches of the first proprotein convertase subtilisin/kexin type 9 (PCSK9 inhibitors), Repatha (evolocumab) and Praluent (alirocumab) by 2016, the launch of ETC-1002 by 2021, and increases in the global prevalence of ACS. Dr Michela J McMullan, GlobalData's Analyst covering Cardiovascular and Metabolic Disorders, explains: "At present, a large proportion of patients with clinical atherosclerotic cardiovascular disease cannot reach guideline recommended levels of LDL-C with the standard of care therapies, which leads to recurrent ACS events. "However, the revolutionary PCSK9 inhibitors Repatha and Praluent have both truly demonstrated their efficacy in lowering LDL-C in their pivotal Phase III trials, as 57% and 58% reductions in LDL-C from baseline compared to placebo were observed for evolocumab and alirocumab, respectively." Esperion's ETC-1002, a novel lipid-lowering drug, is another therapy set to drive the ACS market. It has shown impressive efficacy in its Phase IIb study and is initiating a sweep of Phase III trials in 2016. See Also: Atrial Fibrillation market to peak in 2022 before rapid decline to $4.9 bn by 2025 As the drug is an oral, once-daily treatment, GlobalData believes that Esperion may be a viable competitor in the latter half of the forecast period by capturing the majority of patient share from the statin-intolerant patient population. Dr McMullan continues: "Generally speaking, the ACS market is a highly lucrative area for pharmaceutical companies to invest in drug development. Historically, Merck was the leading innovator in this space, boasting a multitude of therapies to combat atherosclerosis, such as the first-in-class statin Mevacor (lovastatin), as well as Zocor (simvastatin) and the cholesterol absorption inhibitor Zetia (ezetimibe). "However, all of these drugs will lose patent exclusivity within the first half of the forecast period, so it is unlikely that Merck will maintain a competitive position during the forecast period. Amgen and Sanofi/Regeneron, developers of the newly launched PCSK9 inhibitors Repatha (evolocumab) and Praluent (alirocumab), respectively, are now seen as the leading innovators in the lipid-lowering arena." ]]> <![CDATA[Kokilaben Dhirubhai Ambani Hospital announces series of major investments in comprehensive cancer treatment ]]> https://biospectrumindia.com/news/95/8244/kokilaben-dhirubhai-ambani-hospital-announces-series-of-major-investments-in-comprehensive-cancer-treatment-.html https://biospectrumindia.com/news/95/8244/kokilaben-dhirubhai-ambani-hospital-announces-series-of-major-investments-in-comprehensive-cancer-treatment-.html Tue, 16 Aug 2016 11:41:13 +0530 In a major step forward for oncology treatment in Maharashtra, Kokilaben Dhirubhai Ambani Hospital (KDAH) announced in the presence of H'ble Chief Minister Devendra Fadnavis that it will establish 18 cancer care centres across the hinterland of the state. This was accompanied by the launch of the Edgeradiosurgery system-a first-of-its-kind treatment in South Asia to offer a precise, non-invasive alternative to conventional cancer surgery. Further, KDAH has made a significant commitment to cancer care by signing to acquire 18 advanced TrueBeam medical linear accelerators to equip the new cancer centres across Maharashtra. The first of these centres are expected in Akola,Gondia and Solapur to be operational during 2017. The rest of the rollout is aimed to be completed in the next couple of years. Also read: BMS reacquires rights to oncology drug from Asia Partner Focused on advancing healthcare technologies and medical excellence to facilitate healthcare access in India, Mrs. Tina Ambani, Chairperson, KDAH said, "The launch of Edge and the announcement of 18 cancer centres across the state not only represents a significant milestone in our journey but reaffirms KDAH's endeavour to make international innovations available and accessible to all Indians. Cancer is one of the biggest public health challenges of our times and we are ready to tackle it head on with our medical talent and world-class technology." This evolution in advanced radiosurgery was facilitated in the presence of internationally renowned radiation oncology specialists Dr M Salim U Siddiqui from Henry Ford Health System, Detroit, and Professor Carlo Greco, MD, Director of Clinical Research at Champalimaud Centre for the Unknown (CCU) in Lisbon, Portugal. The doctors have been in India to share their knowledge and expertise in the new technology among leading oncologists from across India. Highlighting the benefits of Edge radiosurgery to patients across the country, Dr. Kaustav Talapatra, Head -Radiation Oncology, Kokilaben Hospital, said, "This non-invasive technique uses a GPS-enabled tracking device that helps the radiologist constantly track the movement of affected cells even as the treatment is being delivered, which allows for treatment at affected areas with a high degree of accuracy. This precision radiation provides huge advantages in term of convenience, cost and comfort for patients as the number of sessions reduces significantly, with no incision or hospital stay, thereby enabling them to return to their normal lives within 15-30 minutes or less." "This is a major investment program by Kokilaben Dhirubhai Ambani Hospital to remain ahead of the curve in adopting latest technologies in line with the best global practises in the area of Cancer care across the state of Maharashtra," says Ashok Kakkar, Senior Managing Director, Varian India. He further added that Kokilaben Hospitals planned installations of 18 advanced True Beam machines is by far the largest one time commitment by any single institute. Varian is the market and technology leader in radiotherapy and radiosurgery systems and TrueBeam is the most advanced platform offering fast and precise treatment. So, this programme should make a significant difference to cancer treatments in the region ]]> <![CDATA[Cipla announces changes in management team]]> https://biospectrumindia.com/news/95/4752/cipla-announces-changes-in-management-team.html https://biospectrumindia.com/news/95/4752/cipla-announces-changes-in-management-team.html Tue, 16 Aug 2016 11:40:52 +0530 Cipla Ltd has announced the appointment of Umang Vohra as the Managing Director & Global Chief Executive Officer of the Company effective September 1, 2016.The current incumbent, Subhanu Saxena will step down from his position on August 31, 2016 to attend to emergent family priorities. Subhanu joined Cipla in February 2013 as CEO. Umang joined the company in October 2015 as the Global Chief Financial & Strategy Officer and was elevated as the Global Chief Operating Officer early this year as part of a planned progression. Also read: Zumutor Biologics partners with Bhami Research Samina Vaziralli, Executive Director and the Global Head- Strategy, M&A and Cipla New Ventures will be the Executive Vice-Chairman of Cipla effective September 1, 2016. She will move on from her current responsibilities to focus on board and governance issues, in addition to growing Cipla's strategic priorities through key global partnerships, corporate brand building and public advocacy. MK Hamied will continue to serve on the Board as the non-executive Vice-Chairman. Commenting on these new appointments, Dr YK Hamied, Non-Executive Chairman, Cipla Ltd said, "Having been aware of his personal circumstances, we respect Subhanu's decision to leave Cipla. We thank him for his stewardship over the last three years and also for his availability to his successor over the next few months for any transition support. We are delighted to see two young leaders - Umang and Samina - take on higher responsibilities within Cipla. Both have earned their new positions by the dint of the leadership and impact they have already made. Samina's elevation also reinforces the long-term commitment of the promoter family to Cipla. I am confident that this planned transition will enable Cipla to move into its next orbit of growth while serving true to our mission that None Shall be Denied." ]]> <![CDATA[RCEP agreement threatens to trade away health of millions of people globally]]> https://biospectrumindia.com/news/95/8006/rcep-agreement-threatens-to-trade-away-health-of-millions-of-people-globally.html https://biospectrumindia.com/news/95/8006/rcep-agreement-threatens-to-trade-away-health-of-millions-of-people-globally.html Fri, 12 Aug 2016 17:47:11 +0530 Ahead of the next round of negotiations of the Regional Comprehensive Economic Partnership Agreement (RCEP), which starts on 15th August in Vietnam, MÃ©decins Sans FrontiÃ¨res (MSF) is appealing to the negotiators of all 16 countries to remove harmful intellectual property (IP) provisions that will block access to life-saving medicines for people living in the developing world. The RCEP negotiations are all the more alarming as the harmful IP provisions are designed to block price-lowering generic competition from India. India-widely known as the 'pharmacy of the developing world'-supplies lifesaving, affordable generic medicines needed to treat a number of diseases across the world. More than 97% of the essential drugs MSF uses to treat nearly 250,000 people living with HIV are affordable quality generics from India. "As we move to Test & Start policies for HIV in South Africa and elsewhere in the region, MSF and governments will continue to require an uninterrupted supply of affordable, quality anti-retrovirals for a greater number of people living with HIV," explained Dr Amir Shroufi, Medical Coordinator for MSF in South Africa. "India provides the largest volume of medicines to South Africa of any other country, and healthcare providers will continue to require this trade partnership to supply affordable medicines - not just for HIV buts also to treat other illnesses. We cannot let our patients' lifeline be cut by unjust trade agreements." Last week India's Commerce Minister announced in parliament that Indian negotiators had successfully opposed a provision relating to evergreening - the abusive practice of claiming unjustified secondary patents on medicines to extend monopolies - leading to its removal from the proposed agreement. Although this is an important victory for the global mobilization against the potential negative impact of the FTA on access to medicines, further harmful measures remain on the negotiating table. "While we welcome India's statement on the removal of a provision that weakened patentability standards, there are still several other damaging provisions in the agreement being pushed by Japan and South Korea", said Ms Leena Menghaney, Head-South Asia, MSF Access Campaign. "Proposed provisions such as data exclusivity are still under negotiation in RCEP, and are just another form of evergreening. By delaying the registration of generic versions of a medicine by several years, data exclusivity will effectively give a backdoor monopoly status to pharmaceutical corporations, even for drugs that do not deserve a patent". The leaked draft of RCEP's negotiating text, especially the proposed chapters on Intellectual Property Rights (IPR), reveal that Japan and the Republic of Korea are pushing for IP provisions that go way beyond WTO trade rules. These proposed provisions are similar to the Trans-Pacific Partnership agreement (TPP)-a FTA between the United States and 11 other Pacific-Rim countries-which is considered the worst trade deal ever for access to medicines. Data exclusivity, patent term extensions and over-reaching IP enforcement measures all threaten to limit the ability of developing countries to access affordable medicines from India. The potential harm caused by this FTA is magnified by the fact that the agreement seeks to limit the future ability of India to supply low cost generics of new lifesaving medicines to the world's poorest countries. ]]> <![CDATA[Zumutor Biologics partners with Bhami Research ]]> https://biospectrumindia.com/news/95/8007/zumutor-biologics-partners-with-bhami-research-.html https://biospectrumindia.com/news/95/8007/zumutor-biologics-partners-with-bhami-research-.html Fri, 12 Aug 2016 14:57:28 +0530 Bhami Resarch and Zumutor aim to work in collaboration for a unique portfolio of crystallization enabled Mabs which will be supported by Zumutor's analytical tool kit of niche services. This collaboration will also enable a joint offering for Zumutor's Biosimilars and ADCC improved antibodies using Bhami's crystallization technologies. BRL is a Mangalore based company that works in the area of protein purification, analytical characterization and formulation. Zumutor Biologics Inc is a pre-clinical stage biologics discovery and development company, headquartered in Woburn, MA with Research & Development facility in Bangalore, India. ]]> <![CDATA[BMS reacquires rights to oncology drug from Asia Partner ]]> https://biospectrumindia.com/news/95/7998/bms-reacquires-rights-to-oncology-drug-from-asia-partner-.html https://biospectrumindia.com/news/95/7998/bms-reacquires-rights-to-oncology-drug-from-asia-partner-.html Fri, 12 Aug 2016 10:59:53 +0530 ASLAN Pharmaceuticals (ASLAN), a biotech company focused on the development of immunotherapies and targeted agents for Asia-prevalent tumour types, today announced that Bristol-Myers Squibb will reacquire the rights to ASLAN002 (BMS777607) in China, Australia, Korea, Taiwan and other Asian territories. ASLAN002 is a potent small-molecule dual inhibitor of the cMET receptor tyrosine kinase and RON immune checkpoint. ASLAN in-licensed ASLAN002 in the above-mentioned markets from Bristol-Myers Squibb in November 2011 and has successfully completed a phase 1 study, in which ASLAN002 was shown to be safe and well tolerated. The phase 1 data demonstrated that inhibition of RON resulted in potent inhibition of plasma biomarkers of RON activity. Also read: China, India to drive global central vascular access devices market to $2.3 bn by 2022 ASLAN will receive an upfront payment of $10 million and is eligible to receive development and regulatory milestones in excess of $50 million. In addition, ASLAN is eligible to receive royalty payments on future world-wide sales of ASLAN002. Bristol-Myers Squibb resumes responsibility for all development and commercialisation activities and expenses. Commenting on the agreement, Dr Carl Firth, Chief Executive Officer of ASLAN Pharmaceuticals, said: "The acquisition of ASLAN002 by Bristol-Myers Squibb supports ASLAN's strategy to in-license investigational programmes and apply the unique development expertise of our team to accelerate the generation of high-quality data and significantly increase the value of a programme. The commercial terms of the agreement further strengthen ASLAN's financial position following the closing of our recent financing rounds; we are in a very strong position to continue to build our proprietary pipeline of novel clinical programmes." ]]> <![CDATA[ Govt will play the role of facilitator to ensure that entrepreneurs and investors feel at home in Karnataka: Kharge]]> https://biospectrumindia.com/news/95/8418/-govt-will-play-the-role-of-facilitator-to-ensure-that-entrepreneurs-and-investors-feel-at-home-in-karnataka-kharge.html https://biospectrumindia.com/news/95/8418/-govt-will-play-the-role-of-facilitator-to-ensure-that-entrepreneurs-and-investors-feel-at-home-in-karnataka-kharge.html Thu, 11 Aug 2016 09:57:00 +0530 Priyank Kharge, son of veteran Congress leader Mallikarjun Kharge and the youngest face in Siddaramaiah's team, is the new minister for information technology and biotechnology. He also holds Tourism as additional portfolio. Kharge, who holds a diploma in computer science, is expected to infuse enthusiasm into a ministry that must interact with aspirational youth and the high-profile IT and BT sector in Bengaluru. In his interaction with the media he said that the government will play the role of facilitator to ensure that entrepreneurs and investors feel at home in Karnataka. ]]> <![CDATA[NATCO receives final approval for generic TAMIFLU]]> https://biospectrumindia.com/news/95/7661/natco-receives-final-approval-for-generic-tamiflu.html https://biospectrumindia.com/news/95/7661/natco-receives-final-approval-for-generic-tamiflu.html Wed, 10 Aug 2016 12:00:49 +0530 Natco Pharma Limited has received final approval of Abbreviated New Drug Application (ANDA) containing a paragraph IV certification filed with the US Food and Drug Administration (FDA) for generic versions of TAMIFLU oral capsules (Roche's trade name for Oseltamivir Phosphate), 30 mg, 45 mg and 75 mg. Also read: Sanofi receives FDA approval for Adlyxin Earlier in December, 2015, NATCO and Alvogen settled a patent infringement with Gilead Sciences, Inc., Hoffmann-La Roche Inc., F. Hoffmann-La Roche Ltd. and Genentech, Inc. Under the terms of the settlement, NATCO's partner Alvogen will be able to market the oseltamivir phosphate capsules before the expiration of the pediatric exclusivity period listed in FDA's Orange Book for U.S. Patent No. 5,763,483, which is February 23, 2017. TAMIFLU oral capsules had U.S. sales of approximately $403 Million for twelve months ending December 2015, according to IMS Health. ]]> <![CDATA[Next National Deworming Day on August 10]]> https://biospectrumindia.com/news/95/7449/next-national-deworming-day-on-august-10.html https://biospectrumindia.com/news/95/7449/next-national-deworming-day-on-august-10.html Tue, 09 Aug 2016 17:31:31 +0530 According to the 2012 report 'Children in India', published by the Ministry of Statistics and Program Implementation, Government of India, 48% of children under the age of 5 years are stunted and 19.8% are wasted, indicating that half of the country's children are malnourished. The next National Deworming Day, a flagship initiative of the Government of India's Ministry of Health and Family Welfare, will be implemented on August 10, 2016, in the 27 states and union territories with high worm burdens. National Deworming Day is a nation-wide, preschool (anganwadi) and school-based deworming program that aims to provide all children between the ages of 1-19 years with deworming treatment. Also Read: World Hepatitis Day: 'India lagging behind in Hepatitis research' On National Deworming Day, Albendazole 400 mg chewable tablet will be administered to children in anganwadis, government, government-aided, and some private schools as well as children who are out-of-school or are unregistered in anganwadis. The mop-up day, on August 17, will be conducted to reach children who did not get dewormed on deworming day due to sickness or absenteeism. Given the health and educational impact that worm infections can have on children, parents are encouraged to send their children to schools and anganwadis and take the deworming tablet on that day, in the states that will conduct National Deworming Day. Out-of-school children will also be dewormed in anganwadis. Based on WHO guidelines the Government of India has mandated that 27 States and Union Territories conduct a second round of deworming as per prevalence rates. School-based mass deworming program is safe, cost-effective, and can reach millions of children quickly. Deworming has been shown to reduce absenteeism in schools; improve health, nutritional, and learning outcomes; and increase the likelihood of higher-wage jobs later in life. Side effects are mild and can include nausea, vomiting, and dizziness especially in children with high worm loads. The first National Deworming day was conducted in 2015 in 11 states, treating 89 million children. This year, 33 states took part in the February 2016 round when 179 million children were dewormed. ]]> <![CDATA[Sanofi receives FDA approval for Adlyxin]]> https://biospectrumindia.com/news/95/7483/sanofi-receives-fda-approval-for-adlyxin.html https://biospectrumindia.com/news/95/7483/sanofi-receives-fda-approval-for-adlyxin.html Tue, 09 Aug 2016 17:09:04 +0530 Sanofi announced that the US Food and Drug Administration (FDA) has approved Adlyxin (lixisenatide), a once-daily mealtime GLP-1 receptor agonist injection indicated as an adjunct to diet and exercise for the treatment of adults with type 2 diabetes. "The approval of Adlyxin reaffirms our continued commitment to addressing the challenges faced by people living with diabetes when trying to reach and maintain their individual blood glucose (HbA1c) targets," said Mr Peter Guenter, EVP, Head, Global Diabetes & Cardiovascular Business Unit, Sanofi. "We are pleased with this approval, as it offers us the opportunity to continue helping patients treated with basal insulin who remain uncontrolled." Also Read: FDA grants EUA to Siemens' Zika assay The approval of Adlyxin was based on FDA review of results from the GetGoal clinical program and findings from the ELIXA trial, which successfully addressed the FDA's request to demonstrate CV safety. The GetGoal clinical program, which included 13 clinical trials involving more than 5,000 adults with type 2 diabetes worldwide, evaluated the safety and efficacy of lixisenatide in adults with type 2 diabetes. All studies of the GetGoal program successfully met the primary efficacy endpoint of HbA1c reduction. The most common adverse events reported for Adlyxin included nausea, hypoglycemia and vomiting. Adlyxin will be available in a disposable pre-filled pen in a single dose of 20 micrograms. Patients will also receive a disposable pre-filled pen in a single dose of 10 micrograms that they should initiate once daily for 14 days. On Day 15, patients will increase dosage to 20 micrograms once daily. Adlyxin is approved under the proprietary name, Lyxumia in more than 60 countries and marketed in over 40. Commercial launches include most EU countries, Japan, Brazil, Mexico and India. Adlyxin was in-licensed from Zealand Pharma. ]]> <![CDATA[Mylan completes acquisition of Meda]]> https://biospectrumindia.com/news/95/7024/mylan-completes-acquisition-of-meda.html https://biospectrumindia.com/news/95/7024/mylan-completes-acquisition-of-meda.html Mon, 08 Aug 2016 12:53:33 +0530 Mylan NV has announced that it has completed the settlement of its recommended public offer to the shareholders of Meda Aktiebolag (publ.) to tender all their shares in Meda to Mylan (the "Offer"). As previously announced, the Offer was accepted by shareholders holding approximately 94% of the total number of outstanding shares and votes in Meda, as of July 29, 2016. Upon the completion and settlement of the Offer, Mylan acquired each of these shares in accordance with the terms of the Offer. The Offer was initially announced on Feb. 10, 2016 and it was declared unconditional on Aug. 2, 2016. The acceptance period expired on July 29, 2016 and will not be extended. Also read: Mylan to acquire Meda for $9.9 billion Mylan Chairman Robert Coury commented, "We are very pleased to have received the overwhelming shareholder support required to complete our acquisition of Meda. Mylan continues to differentiate itself among the world's pharmaceutical companies in terms of our unique profile and growth trajectory. The addition of Meda will only further add to our existing leadership position within our space and continue to create significant value for our shareholders and other stakeholders. On behalf of Mylan's entire board of directors, we welcome our new Mylan shareholders and look forward to them sharing in the anticipated future success of our combined company." Mylan CEO Heather Bresch continued, "The addition of Meda builds on everything we have put in place around the world, creating even greater scale, breadth and diversity across products, geographies and sales channels. As a result, our R&D and manufacturing platform is unmatched, and we now have a more powerful global commercial infrastructure across developed and emerging markets and branded, generic and over-the-counter products. This transaction also is extremely compelling financially, providing significant accretion to Mylan's adjusted earnings per share, the opportunity for substantial synergies and further acceleration of our growth. Importantly, I would like to welcome Meda's talented and dedicated workforce to the Mylan family, and I look forward to their contributions as we strive to deliver better health for a better world." Mylan President Rajiv Malik added, "With the addition of Meda, Mylan now has six $1 billion therapeutic franchises, and through our enhanced scale and expanded commercial capabilities, we see significant opportunities to further distinguish Mylan among our customers and patients. Allergy/respiratory, pain/CNS and dermatology - recently bolstered by our acquisition of the Renaissance topicals business - represent just a few of the exciting areas where we expect to create additional value from our combined portfolio, pipeline and capabilities. Meda also opens up a number of new opportunities for us, such as significantly expanding our over-the-counter presence into a $1 billion business. Additionally, Meda accelerates our expansion in attractive emerging markets, such as China, Southeast Asia, Russia and the Middle East, and provides us opportunities to maximize our efficient, high quality operating platform and broad product portfolio. I too would like to extend a warm welcome to the Meda team and am excited to begin integrating our businesses and bringing together the best from both of our organizations." Meda is now a controlled subsidiary of Mylan. Mylan intends to initiate compulsory acquisition proceedings for the remaining shares in Meda in accordance with the Swedish Companies Act (Sw. aktiebolagslagen (2005:551)) and has acted to have the Meda shares delisted from Nasdaq Stockholm. ]]> <![CDATA[FDA granted EUA to Siemens' Zika assay]]> https://biospectrumindia.com/news/95/7027/fda-granted-eua-to-siemens-zika-assay.html https://biospectrumindia.com/news/95/7027/fda-granted-eua-to-siemens-zika-assay.html Mon, 08 Aug 2016 12:52:59 +0530 The US Food and Drug Administration (FDA) has granted Siemens Healthcare Diagnostics Inc. (Siemens) an Emergency Use Authorization (EUA) for its real-time PCR Zika Virus assay, the VERSANT Zika RNA 1.0 Assay (kPCR) Kit. With respect to Zika in vitro diagnostic tests, FDA has been authorized to issue EUAs to allow for use of unapproved medical products or unapproved uses of approved medical products when, among other circumstances, there are no adequate, approved, and available alternatives and certain additional criteria are met. Also read: RealStar Zika Virus Test "The FDA's emergency use authorization of the VERSANT Zika RNA 1.0 Assay (kPCR) Kit from Siemens can lead us one step closer to stopping the spread of the Zika virus," says Fernando Beils, Vice President, Head of Molecular Diagnostics, Siemens . "Being able to quickly diagnose patients will help physicians to more efficiently manage those affected." The VERSANT Zika RNA 1.0 Assay (kPCR) Kit is capable of detecting the presence of Zika virus, which can be an earlier indicator of Zika virus infection than anti-Zika antibodies. The molecular test is validated for plasma, serum, and urine (collected alongside a patient-matched serum or plasma specimen) from individuals meeting CDC Zika virus clinical criteria and/or CDC Zika virus epidemiological criteria, and is designed to run on the Siemens VERSANT kPCR Sample Prep automated platform, along with several commercially available thermal cyclers. The assay must be run by laboratories in the United States that are certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. § 263a, to perform high complexity tests, or by similarly qualified non-U.S. laboratories. The VERSANT Zika RNA 1.0 Assay (kPCR) Kit has not been FDA cleared or approved and is only authorized for use for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of in vitro diagnostic tests for detection of Zika virus and/or diagnosis of Zika virus infection. ]]> <![CDATA[Glenmark receives ANDA approval for Nystatin, Triamcinolone Acetonide ointment]]> https://biospectrumindia.com/news/95/7025/glenmark-receives-anda-approval-for-nystatin-triamcinolone-acetonide-ointment.html https://biospectrumindia.com/news/95/7025/glenmark-receives-anda-approval-for-nystatin-triamcinolone-acetonide-ointment.html Mon, 08 Aug 2016 12:52:30 +0530 Glenmark Pharmaceuticals USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (USFDA) for Nystatin and Triamcinolone Acetonide Ointment USP, 100,000 units/1 mg per gram, the generic version of Nystatin and Triamcinolone Acetonide Ointment USP, 100,000 units/1 mg per gram of Taro Pharmaceuticals. According to IMS Health sales data for the 12 month period ending April 2016, the Nystatin and Triamcinolone Acetonide Ointment USP market1 achieved annual sales of approximately $37.5 million. Glenmark's current portfolio consists of 114 products authorized for distribution in the US marketplace and 62 ANDA's pending approval with the USFDA. In addition to these internal filings, Glenmark continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio. ]]> <![CDATA[No license needed to import & export biological samples from Aug 4, 2016]]> https://biospectrumindia.com/news/95/7623/no-license-needed-to-import-export-biological-samples-from-aug-4-2016.html https://biospectrumindia.com/news/95/7623/no-license-needed-to-import-export-biological-samples-from-aug-4-2016.html Fri, 05 Aug 2016 16:16:56 +0530 Biotech companies, CROs, research centers and other can relax now. The government has allowed hassle-free import and export of various biological samples by removing the mandatory requirement of an export/import license for these samples. This great step was notified by the Director General of Foreign Trade (DGFT) by Notification number 19/2015-2020 by DGFT director general, Mr Anup Wadhawan on 4th August 2016. An ABLE team, led by Honorary Chairperson, Dr Kiran Mazumdar-Shaw, had worked tirelessly for the past three months with various government agencies to get these restrictions removed. Prior to this, companies, particularly those in the contract research sector, were forced to go through a licensing process that took almost 4-5 months of paper work to get or send out every human biological samples for research or commercial purposes. Every such sample handling had to be authorized by the Indian Council of Medical Research (ICMR). The ICMR committee that approves such samples handling meets once in three months and hence the process used to take 4-5 months to get approval for each imported/exported sample, causing immense delays to CRO companies. This was because, there was strict deadlines of 3st January, 20th April, 31st July and 31st October to submit applications to the ICMR committee prior to each meeting. And no mid-term applications were entertained. With the new notification, amending the existing rules that made it mandatory to get import/export license, an organization has to only give a self-certification to the customs authority that they are /will follow all the applicable rules, regulations and procedures for safe transfer and disposal of the biological samples. According to the DGFT notification, customs authorities at all exit and entry points have been informed about the revised guidelines related to the handling of biological samples. Appropriate changes in the relevant software on the Customs networks. "The import of human biological samples by the Indian diagnostic laboratories/Indian Clinical Research Centers for lab analysis/ R&D testing or export of these material to foreign laboratories should be permitted by customs authorities at the port of entry/exit without prior approvals ( Import license/export permit) from any other government agency, provided the concerned Indian company/agency submits an undertaking that they are following and will follow all the applicable rules, regulations and procedures for safe transfer and disposal of the biological samples being imported/exported as per the related norms/regulations set by WHO/DFT/SCOMET items in Export Policy of ITC (HS), 2012 schedule2 ( export policy)/Ministry of Environment , Forests and Climate Change, Government of India, to the Customs authorities at the port of entry/exit along with details of such samples," says the DGFT notification. Source: ABLE ]]> <![CDATA[Tata Trusts, Gilead sign MoU to address viral hepatitis ]]> https://biospectrumindia.com/news/95/7845/tata-trusts-gilead-sign-mou-to-address-viral-hepatitis-.html https://biospectrumindia.com/news/95/7845/tata-trusts-gilead-sign-mou-to-address-viral-hepatitis-.html Fri, 05 Aug 2016 11:00:27 +0530 Tata Trusts and Gilead Sciences, Inc.signed a Memorandum of Understanding (MoU) under the presence of Ratan Tata, Honorable Chairman, Tata Trusts to explore collaborating within India on an initiative to address the burden of viral hepatitis in the country. This effort takes place in the context of an expanding focus on the public health challenges posed by serious diseases, including viral hepatitis, representing significant unmet medical needs in India. Under the MoU, Tata Trusts and Gilead will form a Joint Program Committee to implement activities pertaining to (1) prevention, awareness and education, (2) testing and treatment, and (3) health systems strengthening activities in the field of viral hepatitis in India. Linkages with state governments, non-governmental organizations and public health agencies will be established to promote the cause. Hepatitis viruses B (HBV) and C (HCV) pose a serious threat of becoming a "silent epidemic" in India. HBV is the second most common cause of acute viral hepatitis in India, with a prevalence of approximately 4% - more than 40 million individuals are estimated to carry the virus. The prevalence of HCV infection in India is approximately 1%. Most infected persons are unaware of their chronic carrier status. Left untreated, viral hepatitis can lead to life-threatening liver cirrhosis (or scarring), liver failure and liver cancer. The burden that the diseases place on society through the loss of a productive workforce and on the healthcare system is acute. Speaking on the occasion, R Venkataramanan, Managing Trustee, Tata Trusts, said, "As a part of our overall health strategy aimed at addressing communicable diseases in India, we look forward to partnering with Gilead to create unique models to reduce the prevalence of viral hepatitis in the country." Gregg Alton, Executive Vice President, Commercial and Access Operations Asia, Latin America and Africa, Corporate and Medical Affairs at Gilead, said, "We are very pleased to have the opportunity to partner with Tata Trusts, an organization that shares our goal of improving people's health and quality of life. Viral hepatitis presents a complex public health challenge in India, and by working in partnership and pooling our expertise, we hope to identify sustainable initiatives that can have a lasting impact on the burden of disease." ]]> <![CDATA[A gateway to European markets]]> https://biospectrumindia.com/interviews/95/8419/a-gateway-to-european-markets.html https://biospectrumindia.com/interviews/95/8419/a-gateway-to-european-markets.html Thu, 04 Aug 2016 14:57:55 +0530 IDA Ireland (Investment & Development Agency) is Irish Government's investment and development agency responsible for attracting Foreign Direct Investment (FDI) to Ireland. The country houses tech giants including Facebook, Sanofi, Intel, Yahoo, Adobe, Microsoft, SAP, HP, Apple, LinkedIn, Deutsche Bank, Google and Amazon among others. IDA is in business since the 1950s, and has offices in Australia, China, India, Japan, Korea and Singapore. It employs over 300 people and half of them are from overseas. Based in Shanghai, Mr John Conlon is the EVP and head of APAC Operations at IDA Ireland. He recently visited India on a business trip, and spoke exclusively to BioSpectrum providing deep insights and happenings in Ireland's Life Sciences sector, and why Indian Pharma and Biotech companies should consider investing more in Ireland than ever before. For Ireland, 70 percent of its business comes from the US; 20 percent from Europe, and the rest from the APAC. In the next two to five years, the country aims to accelerate its business to the next level. With a population of 5 million, the country is a host to 2 million workforce. Ireland's GDP stands at â‚¬215 billion and its exports are worth â‚¬200 billion. The country's pharma exports amounts to â‚¬64 billion, and medtech alone is about â‚¬15 billion, totaling the Life Sciences business to a value of â‚¬79 billion. Thriving Ecosystem Decades ago, Pfizer was the first pharma company to invest in Ireland. The country now boasts of having nine out of top 10 global pharma companies including Novartis, Johnson & Johnson, Sanofi and AbbVie, except AstraZeneca. In the medtech industry, out of the top 15 global companies, 13 of them operate in Ireland. Its Life Sciences sector alone employs 50,000 professionals and mainly focuses on novel drugs and generics. Ireland produces 30 percent of the world's contact lenses and 25 percent of the global injectables for diabetes. It also manufactures 75 percent of the world's orthopedic knees and 90 percent of Botox. "In 2015, Ireland encountered over 200 major investments. Fifty percent of those companies which invested have never done business in Ireland before. Pharma and Biotech alone have seen investments worth 10 billion Euros in the last 10 years. Between 2012 and 2015, we have had 4 billion Euros worth investments in this sector," said Mr Conlon. Manufacturing excellence in Biopharmaceuticals is a hallmark of Ireland's success in the sector. The country has now developed 18 manufacturing sites till 2015. Clinical Trials Major Indian corporates in Ireland include Wockhardt, Infosys, Tata, Wipro and Tech Mahindra to name a few. Ireland is more known for its excellence in managing clinical trials than running them. "The population is very small. If you want to run clinical trials Europe would be the best place. But we are more on the clinical trials management space," stated Mr Conlon. Ireland is the gateway to the European markets, he said. Indian companies in Ireland face the same market challenges as elsewhere. The Irish Government has become cost-conscious and it controls the healthcare spends. Irish Fundings Indian companies are expected in providing best quality of services and products. "India is strong in generics, and its quality should meet the EU standards. If Indian companies want to access the EU markets, then Ireland would be the place to start with," Mr Conlon held. There are many fundings of different varieties offered by the Irish Government to international companies. Science Foundation Ireland (SFI) funds basic research in the Biopharmaceutical sector in the areas of cancer, auto-immune disease and Alzheimer's. Recently, SFI signed a deal with Pfizer for a jointly-funded Biomedical research, helping Pfizer's drug discovery efforts in and out of Ireland. The Irish Government provides capital grants, employment grants, and for existing companies it offers training grants, R&D development grants, and R&D tax credits which is about 25 percent. "There are many financial mechanisms which depend on the budget and the relevancy of the companies. Organizations will not get all of the grants but it will a combination of grants, which makes sense. Grants are provided as an assistance to setup in Ireland and not a reason to setup. Companies are there for talent, track record, ability to run facilities and export products," emphasized Mr Conlon. Ease Of Business He also pointed about the excellence in Ireland's education system and the ease of doing business. "One can easily setup companies in Ireland. The ease of doing business is excellent. English speaking talent, access to the EU market, being a member of the European Single Currency, exceptional talent base including engineers, managers, sales and R&D professionals, and excellent University system all add to Ireland's great business ecosystem," noted Mr Conlon. The National Institute for Bioprocess Research and Training (NIBRT), created from a â‚¬60 million investment by the IDA, offers practical training to thousands of people every year. Start-up Ecosystem Enterprise Ireland is the Government organization responsible for the development and growth of Irish enterprises in global markets. "It helps grow Irish companies. They fund three start-ups per week. Ireland is one of the entrepreneurial countries in Europe," expressed Mr Conlon. The country has a concentrated cluster of electronics, IT and Biotech companies. "We have Pfizer, Microsoft, Google, eBay, Yahoo, IBM located next to each other. It leads to interesting collaborations giving rise to hybrid products," he highlighted. Bad Business Mr Conlon advises companies to first hire the best general manager while setting up in Ireland. "A good general manager can manage a bad business. But bad general managers can mess up a good business. It's worth spending good money in hiring the best personnel who come with great experience, network and culture, and can build business better," he advised. R&D Activities The Irish Government has committed â‚¬8 billion to research funding to further bolster Ireland's reputation as a growing hub for R&D. "A lot of pharma R&D takes place at companies' headquarters which house large labs and facilities. Very little happens in Ireland," he added. "In Ireland, it is more of process development when it comes to cost and drug delivery. However, a lot happens in the medtech space in Ireland." IPRs Companies entering Ireland can register their patents in Ireland and can use the same registration to patent in Europe. "In IPs, Ireland is very similar to India. The process is straight-forward and clear. Companies will see patent protection as an advantage," Mr Conlon said. FDI Global economy, economic crisis and politics - all of them affect investments in Ireland. "There are many commonalities between India and Ireland starting from our national flags. Indian companies and professionals do well in Ireland. We look forward in engaging with Indian companies," he concluded.The Big Picture ï‚§ 9 of the top 10 world's pharmaceutical companies operate in Irelandï‚§ 7th largest exporter of medicinal and pharmaceutical products in the world in 2014ï‚§ â‚¬39 billion in annual exports of pharma, bio and chemistry produceï‚§ 75+ pharmaceutical companies ï‚§ 33 FDA approved pharma & biopharma plants ï‚§ 12.5% rate of Corporation Tax on trading activities ]]> <![CDATA[Dr. Reddy's completes acquisition of product portfolio from TEVA ]]> https://biospectrumindia.com/news/95/8206/dr-reddys-completes-acquisition-of-product-portfolio-from-teva-.html https://biospectrumindia.com/news/95/8206/dr-reddys-completes-acquisition-of-product-portfolio-from-teva-.html Thu, 04 Aug 2016 12:14:30 +0530 Dr Reddy's Laboratories announced that it successfully completed the previously announced acquisitionof eight Abbreviated New Drug Applications (ANDAs) in the US from Teva Pharmaceutical Industries and an affiliate of Allergan plc. The acquired portfolio consists of products that are being divested by Teva as a precondition to its closing of the acquisition of Allergan's generics business. The portfolio being acquired is a mix of six ANDAs pending approval,oneapproved ANDA and one ANDA with tentative approval,and comprises complex generic products across diverse dosage forms. The combined sales of the branded versions of the products in the US is approximately $3.5 billion MAT for the most recent twelve months ending in June2016 according to IMS Health. The products include Buprenorphine HCl/Naloxone HCl Sublingual Film (generic equivalent to Suboxone sublingual film), Ethinyl estradiol/Ethonogestrel Vaginal Ring (generic equivalent to NuvaRing), Ezetimibe/Simvastatin Tablets (generic equivalent to Vytorin), Metformin HCl/Saxagliptin ER Tablets (generic equivalent to Kombiglyze XR), Tobramycin Inhalation Solution (generic equivalent to Tobi), Phentermine HCl/Topiramate ER Capsules (generic equivalent to Qsymia), Imiquimod Topical Cream (generic equivalent to Zyclara 3.75% Cream), and Ramelteon Tablets (generic equivalent to Rozerem). ]]> <![CDATA[Cipla joins global movement to eliminate viral hepatitis by 2030 ]]> https://biospectrumindia.com/news/95/8208/cipla-joins-global-movement-to-eliminate-viral-hepatitis-by-2030-.html https://biospectrumindia.com/news/95/8208/cipla-joins-global-movement-to-eliminate-viral-hepatitis-by-2030-.html Wed, 03 Aug 2016 14:38:21 +0530 ACT-C (awareness, counselling and treatment of Hepatitis C), a public service initiative of Cipla supported by Cipla Foundation took the message of 'NOhep' to people on World Hepatitis Day. NOhep is a global movement of World Hepatitis Alliance that calls for people across the world to sign up for the initiative and take action to eliminate hepatitis by 2030. Viral hepatitis, an inflammation of the liver due to a virus, is the 7th leading cause of death globally, accounting for 1.4 million deaths per year - more than HIV/AIDS or malaria. The most common of the viruses are hepatitis B and C, which affect up to 400 million worldwide and cause 80% of liver cancer deaths worldwide. Hepatitis infection is a significant health issue, every year, over one lakh people in India are afflicted by hepatitis C, with an estimated 1 in every 100 people infected by the Hepatitis C Virus (HCV). People with chronic hepatitis C can live for decades without the symptoms or feeling sick and do not know that they are infected. When symptoms do appear, they often are a sign of advanced liver disease. To create awareness and sensitize people on the need of screening for hepatitis, Cipla Foundation has been galvanizing doctors, hospitals, voluntary and non-government organizations (NGOs), and other stakeholders to come together for joint action. ]]> <![CDATA[Piramal's $25 Mn plan to expand its Lexington facility ]]> https://biospectrumindia.com/news/95/3904/piramals-25-mn-plan-to-expand-its-lexington-facility-.html https://biospectrumindia.com/news/95/3904/piramals-25-mn-plan-to-expand-its-lexington-facility-.html Wed, 03 Aug 2016 14:38:01 +0530 Piramal Pharma Solutions' plan focuses on expanding the Lexington site capabilities and capacity for commercial aseptic manufacturing. This will be done by increasing vial filling capability and lyophilization capacity, as well as upgrades to the associated facilities and utilities. Piramal's Lexington site has a strong pipeline of products which are expected to be commercialized in next 3 to 5 years. Add to that the fast growing Sterile Market in the US, recent consolidations in the CMO space and shut down of many manufacturing sites in the US, has created a big demand for quality manufacturers in the Sterile segment. The Sterile market in the US and Europe is growing at a healthy rate of 11% and the Contract Manufacturing in the Sterile Dosage Form is growing at 13% year on year. Piramal believes that it can take advantage of the market situation and grow it Lexington business multi-fold. Phase 1 of the expansion of the Lexington facility will add a new manufacturing suite including a high-speed vial filling machine that provides controlled/safe environment for handling potent materials with an advantage of automated Vial Washing and Sterilization. Also as part of the first phase of expansion, Piramal will install a new isolator based vial filler in its existing manufacturing suite, which is a newer technology and considered much higher in quality standards. Combined, the two fillers installed under Phase I of the expansion will increase the company's vial filling capabilities by more than five-fold. Phase 2 of the expansion will include the installation of two state-of-the-art lyophilizers and are planned to integrate with the new filler line in the new manufacturing suite offering dedicated capacity for both potent and non-potent products Mr Vivek Sharma, CEO - Pharma Solutions, Piramal Enterprises, commented: "Since our initial investment the Kentucky site has demonstrated both leadership and growth, and we are pleased to announce this next phase of investment to enhance capability and capacity. We appreciate the active support from the State of Kentucky, the local Government, and most importantly, the community, as we continue our growth plans in Lexington. The expansion in our capacity at Kentucky will help us better serve our customers who are looking for us to deliver solutions that will improve the standard of care." Mr Bill Wedlake, President of Piramal Pharma Solutions Formulations Business added, "We are extremely excited to initiate this expansion and continue the company's vision of becoming the premier aseptic manufacturing service provider that began with the acquisition of Coldstream Laboratories in January of 2015." ]]> <![CDATA[Tata Trusts, The Global Fund launch 'The India Health Fund' ]]> https://biospectrumindia.com/news/95/8237/tata-trusts-the-global-fund-launch-the-india-health-fund-.html https://biospectrumindia.com/news/95/8237/tata-trusts-the-global-fund-launch-the-india-health-fund-.html Wed, 03 Aug 2016 10:47:02 +0530 Tata Trusts, in association with The Global Fund, launched 'The India Health Fund (IHF)'in Mumbai. The India Health Fund is a pioneering vehicle by Tata Trusts, designed to not only influence philanthropic capital within India, but also serve as a trusted mechanism to generate significant impact in addressing key health challenges in the country - starting with malaria and tuberculosis. The IHF looks at catalyzing agility and innovation within large scaled programs of The Global Fund and the Government of India. Addressing infectious diseases like TB and malaria, the India Health Fund plans to support programs and projects that develop new products or strategies for innovative business models and innovative partnerships or financing mechanisms that significantly scale existing effective solutions. The investments made by the IHF will be aligned to national strategies and link to clear pathways of scale including government platforms, private health networks, open source technology or sustainable organization growth. The India Health Fund is a lead initiative of Tata Trusts, with technical support from the Global Fund. The launch, hosted by Mr Ratan Tata witnessed the presence of noted corporate leaders and philanthropists across the globe. The initiative was acknowledged as a landmark step in the control of dreaded diseases such as TB and Malaria, by all dignitaries at the event. Giving a thumbs-up to the IHF, the dignitaries present stated that they look forward to being a significant part of the initiatives to eradicate TB and Malaria. Speaking on the real role of philanthropy, guests reflected on how public-private partnerships (PPPs) can be streamlined to bring out tangible outcomes. They suggested that factors such as fueling innovation, adequate risk capital, scaling pilots and unleashing the power of technology, will help to garner effective outcomes. The discussion laid strong emphasis on amplifying the impact of the Government's initiatives for eradicating TB and Malaria through the India Health Fund. Speaking on the partnership, Mr. Ratan Tata, Chairman, Tata Trusts said, "The India Health Fund is an ambitious project undertaken by Tata Trusts along with The Global Fund and the Government of India. Infectious diseases such as Malaria and Tuberculosis though widespread are treatable and controllable. In order to overcome the challenges associated with this issue, we should use innovations to create models that are not geographically bound and can be replicated anywhere in the world. The India Health Fund will endeavor to combine innovation and effort for the implementation of the project at a large scale." Applauding the launch of IHF, US Ambassador to India, Richard R. Verma said, "The development challenges we face today truly require 'all hands on deck' and it's more critical than ever that we combine all of our resources and work hand-in-hand to prevent, treat and care for these diseases. That is why the United States - through USAID - plans to join the India Health Fund." "We commend Tata Trusts for launching and hosting the truly innovative India Health Fund. We are sure it will become a model for many countries around the world providing additional vital resources for health," said Dr. Christoph Benn, Director of External Relations from the Global Fund. "We are proud to partner with Tata Trusts in the development of the India Health Fund. This great initiative will provide new opportunities for philanthropy to improve the lives of millions of people in India and beyond." ]]> <![CDATA[Lupin acquires branded products from Shionogi in Japan ]]> https://biospectrumindia.com/news/95/8364/lupin-acquires-branded-products-from-shionogi-in-japan-.html https://biospectrumindia.com/news/95/8364/lupin-acquires-branded-products-from-shionogi-in-japan-.html Wed, 03 Aug 2016 10:35:28 +0530 Pharma Major Lupin has announced that its Japanese subsidiary Kyowa Pharmaceutical Industry has entered into a strategic asset purchase agreement with Shionogi & Co., Ltd. on August 1, 2016, to acquire 21 long-listed products from the Japanese pharma major, effective December 1, 2016, subject to certain closing conditions and regulatory approvals including the transfer of marketing authorization of the products to Kyowa. With the vision of growing globally as a drug discovery-based pharmaceutical company, Shionogi is focusing its resources on its core therapeutic and marketing areas, while continuing to create innovative medicines to support future growth and to strengthen its business operations. As a part of this growth strategy, Shionogi would transfer 21 long-listed products to Kyowa, the Japanese subsidiary of Lupin Limited. Kyowa is amongst the top 10 Generic companies in Japan and a market leader in Central Nervous System (CNS) space well known for its "AMEL" brand, in addition to other generic pharmaceutical products in its portfolio. With this acquisition, Kyowa will rank 6th amongst generic companies in Japan. The 21 products cover therapy areas such as Central Nervous System (CNS), Oncology, Cardiovascular and Anti-infectives. These 21 products had sales of JPY 9, 400 million (USD 90 million) collectively on NHI price basis. Commenting on the acquisition, Mr. Nilesh Gupta, Managing Director of Lupin Limited said, "This acquisition marks Lupin's foray into the Japanese Branded market in-line with our aspirations to build and strengthen our specialty business globally. The new Branded product portfolio has a strong fit with Lupin's Kyowa business, as it adds depth and reach to its current CNS portfolio and other therapy areas." Dr. Fabrice Egros, President - Asia Pacific & Japan, Lupin Limited commented, "Japan is a very important market for us. The acquisition strongly supports our future growth plans and the brands have robust synergies with Kyowa's existing portfolio which will enable Lupin to build a wide customer base across the key therapies." Dr. Isao Teshirogi, President & CEO of Shionogi said, "In the Japanese domestic prescription pharmaceutical market, the core mission of drug discovery-based pharmaceutical companies, such as Shionogi, is to create high-quality new drugs and to make them available to patients. Therefore, I'm very pleased that this agreement with Kyowa could make both aspects of our mission a reality, allowing us to pursue innovative drug discovery with an even more intense focus, while ensuring that our high quality long-listed drugs continue to be delivered to patients to meet their unmet needs." Under the terms of this agreement, Kyowa will book the sales of the 21 prodcuts after December 1, 2016, and Shionogi will receive 15.4 billion yen from Kyowa. ]]> <![CDATA[Controlling blood sugar levels naturally]]> https://biospectrumindia.com/news/95/3934/controlling-blood-sugar-levels-naturally.html https://biospectrumindia.com/news/95/3934/controlling-blood-sugar-levels-naturally.html Tue, 02 Aug 2016 17:59:37 +0530 Nowadays, most of the people are looking for anti-diabetic medications that can help to regulate insulin level in body. Lifespan, a diabetes management clinic, launched its first-ever anti-diabetic powder - Fiberspan, a unique product made from fibrein found in methi seeds. Fiberspan is a supplement that is formulated for people with diabetes. It is low in carbohydrates (with no added sucrose), high in protein and contains soluble fiber. Fibrein contains both insoluble and soluble fiber that significantly reduces blood sugar levels. As many diabetics are burdened by compromised digestive systems, the fiber helps the body to digest food thoroughly and to absorb glucose into the system at a controlled rate. Priced at Rs 465 for 300g, Fiberspan is made from the husk of Trigonella foenum-graecum (fenugreek or popularly known as methi). Soluble fiber reduces the absorption of glucose from intestine to blood and ensures that there is no sudden peak or rush of glucose into the blood stream. Insoluble fiber adds bulk to the stool and causes it to pass through the intestine more quickly. As Fibrespan contains 95% natural fiber extracts, it helps control blood sugar significantly reducing blood sugar levels. High fiber intake is associated with a decreased risk of cardiovascular disease. Fiberspan also reduces abnormal cholesterol and triglycerides and thus a good option for weight management and avoiding hemorrhoids. ]]> <![CDATA[Kedar Upadhye joins Cipla from Reddy's as global CFO]]> https://biospectrumindia.com/news/95/7624/kedar-upadhye-joins-cipla-from-reddys-as-global-cfo.html https://biospectrumindia.com/news/95/7624/kedar-upadhye-joins-cipla-from-reddys-as-global-cfo.html Mon, 01 Aug 2016 17:09:02 +0530 With Mr Upadhye's appointment, Mr Umang Vohra will cease to be the global CFO of Cipla. Mr Umang Vohra will continue to be the global Chief Operating Officer (COO). Mr Kedar Upadhye is a qualified cost accountant with a follow-on MBA from IIM Bangalore. He brings with him deep experience of the global generics business. Until recently, Mr Kedar Upadhye was VP of global generics finance and head of investor relations at Dr Reddy's. Prior to Dr Reddy's, he worked with Pepsi India and Thermax Group. ]]> <![CDATA[GSK in-licenses antibody for severe asthma from Janssen ]]> https://biospectrumindia.com/news/95/7456/gsk-in-licenses-antibody-for-severe-asthma-from-janssen-.html https://biospectrumindia.com/news/95/7456/gsk-in-licenses-antibody-for-severe-asthma-from-janssen-.html Mon, 01 Aug 2016 11:45:00 +0530 GSK has announced that it has entered into an exclusive, worldwide licence agreement with Janssen Sciences Ireland UC (Janssen) for CNTO 7160, an anti-IL-33R monoclonal antibody currently in phase I clinical development. The agreement covers all therapeutic fields. CNTO 7160 is a biological therapy that prevents interleukin-33 from binding to the ST2 receptor (IL-33R) and could be applicable to a broad spectrum of severe asthmatic populations. There is strong human genetic evidence and target biology linking the IL-33 pathway to asthma and regulation of inflammatory cells known to be important in asthma, including neutrophils and eosinophils. Under the terms of the agreement, GSK will assume all development, manufacturing and commercialisation activities worldwide with the exception of the ongoing phase I study, which Janssen will continue to run through to completion. Janssen will receive up to £175 million comprising an upfront payment, and development and first commercial sales milestones, in addition to tiered royalties on sales and further considerations contingent on future sales performance. Dave Allen, Head of Respiratory R&D at GSK, said: "While current options for the treatment of mild to moderate asthma enable patients to achieve good control of their symptoms, there remains significant unmet need in severe patients. The IL-33 receptor antibody joins our diverse respiratory R&D portfolio of targeted biological therapies and offers the potential to block a fundamental driver of the disease. "Following our recent successful launch of a first-in-class biologic for severe asthma in an eosinophilic population, we plan to investigate this asset's potential to treat other targeted populations, for which there are currently no effective medicines." ]]> <![CDATA[India joins WHO's Global Injection Safety Campaign]]> https://biospectrumindia.com/news/95/7471/india-joins-whos-global-injection-safety-campaign.html https://biospectrumindia.com/news/95/7471/india-joins-whos-global-injection-safety-campaign.html Fri, 29 Jul 2016 18:10:49 +0530 Safe Point India, a not-for profit society working in the field of public health and safety, has lauded and fully endorsed the WHO's and Government of India's noble initiative to eliminate viral Hepatitis by 2030 by launching Global Safe Injection Campaign. It is especially happy to note the acknowledgement of the role that safe injections can play in eliminating a health scourge that claims over 3,50,000 lives each year globally and is the number two communicable disease killer of human lives after tuberculosis. On World Hepatitis Day, India became one of the first countries to join WHO's Safe Injection Campaign which is integral to eliminating strategy of hepatitis by 2030. As per WHO, 33% of Hepatitis B and 42% of Hepatitis C cases are attributed to unsafe injections! It may also be noted that in the South-East Asia Region, viral hepatitis is driving rates of liver cancer and cirrhosis, and is causing premature death and disease with over 100 million people chronically infected with hepatitis B and hepatitis C. Government of India on the World Hepatitis Day committed to renew the effort to eliminate unsafe injections and has announced 3-year transition time for manufacturers to phase out standard disposable syringes and switch to auto disable syringes and safety syringes as part of hepatitis elimination intervention strategy. "Injections should be life giver, not life taker and prevention is always better than cure. Sadly, as pointed out by WHO, nearly 33% of Hepatitis B and 42% of Hepatitis C are attributed to unsafe injections. Unsafe injections mostly in the form of reuse of safety injections continues to be a serious threat to life of patients and health workers, casting shadows over public healthcare and immunization programs while raising individual and national healthcare cost burden," said Rajiv Nath, Project Director & Trustee, Safe Point India, a frontline not-for-profit society working in the field of public health and safety. "I am especially happy to note that safe injections along with vaccination and better access to healthcare has been now been officially endorsed as key to eliminating a major public health scourge. Swach Bharat Campaign for addressing Hepatitis A & E and a Swach Injection Abhiyan has long been needed for addressing Hepatitis B&C for ensuring Clean Healthcare and Clean Needles. This will not only ensure better health to common Indians but would also bring in great savings in terms of public health spending in the long run," added Mr. Nath. According to a WHO study, for every 1$ (67) invested in injection safety, savings are to the tune of over 14 $ (938â‚¹) in hidden cost of public healthcare spending for treatment of ailments. This is substantial and to correlate one can compare with another WHO study - every 1$ invested in immunisation has been resulting in 16$ savings to a Nation. Prevention is far less cost than Cure. Mr Nath informed that a number of pilot projects on injection safety would be undertaken by GoI and WHO starting from Punjab which has the highest incidence of Hepatitis C even though it is an affluent state possibly due to dangerous cocktail of drug abuse and unsafe injection practices . The other states reported with high incidence of Hepatitis C are Haryana, North Eastern States and coastal areas of Andhra Pradesh and Tamil Naidu. ]]> <![CDATA[Developing diagnostics to address the global problem of AMR]]> https://biospectrumindia.com/news/95/7626/developing-diagnostics-to-address-the-global-problem-of-amr.html https://biospectrumindia.com/news/95/7626/developing-diagnostics-to-address-the-global-problem-of-amr.html Fri, 29 Jul 2016 12:59:42 +0530 The Biotechnology Industry Research Assistance Council (BIRAC), Department of Biotechnology, Government of India and Nesta, a United Kingdom based Charity managing the Longitude Prize, organized an outreach event on Thursday in New Delhi to promote the Discovery Awards, which aim to create a pipeline of innovations in the Anti-Microbial Resistance (AMR) diagnostics. BIRAC has committed a funding of GBP 100,000 for the Discovery Awards, to support Indian participants. The Discovery Awards are seed grants to support teams and individuals to further develop their ideas for the Longitude Prize. The British government introduced the Longitude Award in 1714 to support scientists to solve the most pertinent challenges affecting the globe. The current call under the Longitude Prize aims to create a cost-effective, accurate, rapid, and easy-to-use diagnostic test for bacterial infections that will allow health professionals worldwide to choose the right antibiotics for the right bacteria thereby preventing antibiotic misuse and resulting resistance. "AMR is a serious and rising threat to global public health that requires a concerted effort from different sectors. There is an urgent need to develop rapid and affordable diagnostic tools to enable early diagnosis and identification of drug resistant strains of infection. Partnerships are crucial for technology development and we believe our collaboration with Nesta on the Discovery Awards will provide the necessary impetus and mentorship to our Indian innovators as they solve the pressing problem posed by AMR," said Prof. K. VijayRaghavan, Secretary, Department of Biotechnology and Chairman, BIRAC. "In order to develop affordable, faster and better diagnostics, research and innovation is the key. BIRAC is committed to solving emerging public health issues such as AMR, through innovations and in this regard our partnership with Nesta is of high value since collaborating across sectors can prevent the duplication of efforts and can maximize the resources available" said Dr. Renu Swarup, Senior Adviser, DBT, and Managing Director, BIRAC. In the past few decades, AMR has posed a significant public health challenge across the world. The occurrence of resistance to the most commonly used antibiotics has resulted in treatment failure, prolonged illness, disability and greater risk of death and skyrocketing costs of care. The effective management of a number of diseases such as tuberculosis (TB), malaria, HIV and influenza among other diseases, has been compromised due to the emergence drug resistant strains of these diseases. For example, in the case of TB, globally, 3.5% of new TB cases and 20.5% of previously treated TB cases are estimated to have multi-drug resistant TB. "Given the urgency and importance of this issue we need a rapid, accurate, affordable point of care test that is accessible to all communities, and will significantly reduce the misuse and overuse of antibiotics. Encouraging and providing the necessary support to medical technology developers is crucial to drive research and development efforts towards this diagnostic tool. The Discovery Awards presents itself as an ideal platform for fostering research and innovation and our collaboration with BIRAC will help us tap into the vast potential available in India," said Ms. Tamar Ghosh, Lead, Longitude Prize. Dignitaries including Prof. K. Vijayraghavan, Secretary, DBT and Chairman, BIRAC; Dr. Renu Swarup, Senior Adviser, DBT and Managing Director, BIRAC; and Ms. Tamar Ghosh, Lead, Nesta were present at the event. Other participants included representatives from academia, industry and government agencies including Department of Science and Technology, Department of Scientific and Industrial Research and Indian Council for Medical Research. ]]> <![CDATA[Sun Pharma enter into an agreement with Spainish firm Almirall ]]> https://biospectrumindia.com/news/95/7849/sun-pharma-enter-into-an-agreement-with-spainish-firm-almirall-.html https://biospectrumindia.com/news/95/7849/sun-pharma-enter-into-an-agreement-with-spainish-firm-almirall-.html Fri, 29 Jul 2016 12:52:40 +0530 Sun Pharma and Almirall has announced a licensing agreement on the development and commercialization of tildrakizumab for psoriasis in Europe. Tildrakizumab is an investigational IL-23p19 inhibitor currently being evaluated in patients with moderate-to-severe plaque psoriasis. Under terms of the license agreement, Almirall will pay Sun Pharma an initial upfront payment of $50 million. Phase-3 studies of tildrakizumab have recently been completed. Sun Pharma will be eligible to receive development and regulatory milestone payments and, additionally, sales milestone payments and royalties on net sales, the terms of which are confidential. Almirall will be able to lead European studies, and participate in larger Global clinical studies for psoriasis indication subject to the terms of the Sun Pharma - Merck agreements, as well as certain cost sharing agreements. Sun Pharma will continue to lead development of tildrakizumab for other indications, where Almirall will have right of first negotiation for certain indications in Europe. "Sun Pharma is committed to growing our dermatology franchise, with tildrakizumab as our lead investigational compound. We continue to build our pipeline and capabilities in this important therapeutic area of significant unmet need. We are proud to be partnering with a regional leader in dermatology, like Almirall, to bring tildrakizumab to the European market," said Dilip Shanghvi, Managing Director, Sun Pharma. "This agreement with Almirall follows the recent announcement that tildrakizumab is the first IL-23p19 inhibitor to demonstrate positive results in Phase-3 clinical trials and is another step towards preparing for future regulatory milestones that will potentially enable us to bring a new treatment option to patients with moderate-to-severe plaque psoriasis." "This agreement with Sun Pharma allows us to add a novel biologic for treatment of psoriasis to our extensive dermatology portfolio," said Jorge Gallardo, President of Almirall. "This is an exciting time for the treatment of psoriasis, a disease which can take both a physical and emotional toll on patients' lives. Emerging new investigational drugs, like tildrakizumab, are increasingly targeted and will potentially offer patients and physicians another alternative." Additionally, the license agreement has a provision for possible co-promotion agreement at some point in the future, subject to certain conditions. ]]> <![CDATA[Scientists Grow Mini Human Brains]]> https://biospectrumindia.com/news/95/7850/scientists-grow-mini-human-brains.html https://biospectrumindia.com/news/95/7850/scientists-grow-mini-human-brains.html Fri, 29 Jul 2016 12:52:22 +0530 Scientists in Singapore have made a big leap on research on the 'mini-brain'. These advanced mini versions of the human midbrain will help researchers develop treatments and conduct other studies into Parkinson's Disease (PD) and ageing-related brain diseases. These mini midbrain versions are three-dimensional miniature tissues that are grown in the laboratory and they have certain properties of specific parts of the human brains. This is the first time that the black pigment neuromelanin has been detected in an organoid model. The study also revealed functionally active dopaminergic neurons. The human midbrain, which is the information superhighway, controls auditory, eye movements, vision and body movements. It contains special dopaminergic neurons that produce dopamine - which carries out significant roles in executive functions, motor control, motivation, reinforcement, and reward. High levels of dopamine elevate motor activity and impulsive behaviour, whereas low levels of dopamine lead to slowed reactions and disorders like PD, which is characterised by stiffness and difficulties in initiating movements. Also causing PD is the dramatic reduction in neuromelanin production, leading to the degenerative condition of patients, which includes tremors and impaired motor skills. This creation is a key breakthrough for studies in PD, which affects an estimated seven to 10 million people worldwide. Furthermore, there are people who are affected by other causes of parkinsonism. Researchers now have access to the material that is affected in the disease itself, and different types of studies can be conducted in the laboratory instead of through simulations or on animals. Using stem cells, scientists have grown pieces of tissue, known as brain organoids, measuring about 2 to 3 mm long. These organoids contain the necessary hallmarks of the human midbrain, which are dopaminergic neurons and neuromelanin. Jointly led by Prof Ng Huck Hui from A*STAR's Genome Institute of Singapore (GIS) and Assistant Prof Shawn Je from Duke-NUS Medical School, this collaborative research between GIS, Duke-NUS, and the National Neuroscience Institute (NNI) is funded by the National Medical Research Council's Translational Clinical Research (TCR) Programme In Parkinson's disease (PD) and A*STAR. Other collaborators are from the Lieber Institute for Brain Development, the Johns Hopkins University School of Medicine, and the Nanyang Technological University. Assistant Prof Shawn Je from Duke-NUS Medical School's Neuroscience & Behavioural Disorders Programme said, "It is remarkable that our midbrain organoids mimic human midbrain development. The cells divide, cluster together in layers, and become electrically and chemically active in three-dimensional environment like our brain. Now we can really test how these mini brains react to existing or newly developed drugs before treating patients, which will be a game changer for drug development." Prof Tan Eng King, Research Director and Senior Consultant, Department of Neurology at NNI and Lead PI of the TCR Programme in PD, remarked, "The human brain is arguably the most complex organ and chronic brain diseases pose considerable challenges to doctors and patients. This achievement by our Singapore team represents an initial but momentous scientific landmark as we continue to strive for better therapies for our patients." GIS Executive Director Prof Ng Huck Hui said, "Considering one of the biggest challenges we face in PD research is the lack of accessibility to the human brains, we have achieved a significant step forward. The midbrain organoids display great potential in replacing animals' brains which are currently used in research; we can now use these midbrains in culture instead to advance our understanding and future studies for the disease, and perhaps even other related diseases." This research is supported by the National Research Foundation Singapore under its Translational and Clinical Research (TCR) Flagship Programme and administered by the Singapore Ministry of Health's National Medical Research Council. ]]> <![CDATA[World Hepatitis Day: Biocon Initiates Awareness Program on Hepatitis C]]> https://biospectrumindia.com/news/95/8413/world-hepatitis-day-biocon-initiates-awareness-program-on-hepatitis-c.html https://biospectrumindia.com/news/95/8413/world-hepatitis-day-biocon-initiates-awareness-program-on-hepatitis-c.html Thu, 28 Jul 2016 14:27:14 +0530 Biocon Branded Formulations business announced the launch of a new patient support program "Ek Prayaas" through a nationwide awareness drive for Hepatitis C on the occasion of 'World Hepatitis Day.' Biocon's Virology Division set up in April 2015, is driven with a mission of "Saving Lives" with a prime focus on HCV. The 'Ek Prayaas' program in collaboration with healthcare professionals will organize a nationwide HCV awareness campaign across tier I and tier II cities. The program is aimed to educate the common man about the causes and effects of Hepatitis C. According to WHO July, 2016 data, 130-150 million people globally have chronic Hepatitis C infection. It is estimated that about 1.5 crore people in India are infected by Hepatitis C. The Biocon Virology division though in its infancy is extensively engaged with Gastroenterologists, Hepatologists, Blood Banks and Deaddiction Centres to create awareness about HCV, updating HCPs on the recommended HCV management approaches and paving the way towards HCV eradication. Commenting on this program, Prakash S Kayal, Senior Director and Business Head, Virology Division, Biocon said: "Hepatitis C (HCV) is a neglected disease, with very little public awareness on disease and its implications, if left untreated. With the advent of advanced therapies, Hep C is curable if diagnosed and treated on time. Through 'Ek Prayaas' we aim to increase public awareness on Hep C , enabling early diagnosis and treatment to combat HCV and save several innocent lives. Together with our partners we hope to eradicate HCV in India." Hepatitis-C is a viral disease that causes liver inflammation leading to diminished liver function or liver failure. It is referred to as a "silent epidemic" as most people infected with HCV have no symptoms of the disease until liver damage becomes apparent, which may take decades. ]]> <![CDATA[Eli Lilly announces new CEO ]]> https://biospectrumindia.com/news/95/8417/eli-lilly-announces-new-ceo-.html https://biospectrumindia.com/news/95/8417/eli-lilly-announces-new-ceo-.html Thu, 28 Jul 2016 12:41:46 +0530 Eli Lilly and Company announces the appointment of Dave Ricks as its next president and CEO, effective January 1, 2017. At the end of this year, John Lechleiter will retire as Lilly's CEO, to be succeeded by Dave Ricks. Dave, currently a senior vice president at Lilly and the president of our Bio-Medicines group, will become CEO on January 1, 2017. A 20-year Lilly veteran, Dave brings a wealth of global experience to his new role, as he has previously led Lilly affiliates in the U.S., China, and Canada. And, he has immersed himself in numerous facets of the business, including product development, global sales and marketing, and public policy. Since January 2012, he has served as president of Lilly Bio-Medicines, overseeing the development of about half of Lilly's late-stage pharmaceutical pipeline. He is also active in Lilly's corporate responsibility efforts, having served as the chair of United Way of Central Indiana's 2015 annual campaign. Over the next six months, John and Dave will work closely together to assure a smooth handover of leadership. Dave will lead 2017's business planning, with an eye to ensuring that Lilly continues to deliver better and better medicines to the patients who need them-and in so doing, also benefits employees, communities and shareholders. "I'm incredibly proud of Lilly and the people who work here-each of us playing an important part in making life better for people around the world through our medicines," Dave says. "Together, in the years ahead, we can meet and even exceed the high expectations that patients, doctors, health care payers and the rest of society have of Lilly." Today and in the future, we're committed to our promise to make life better for people around the world." ]]> <![CDATA[Zimmer Biomet's collaborates with Indo-UK Institutes of Health]]> https://biospectrumindia.com/news/95/8159/zimmer-biomets-collaborates-with-indo-uk-institutes-of-health.html https://biospectrumindia.com/news/95/8159/zimmer-biomets-collaborates-with-indo-uk-institutes-of-health.html Wed, 27 Jul 2016 16:23:39 +0530 Zimmer Biomet Holdings, a global leader in musculo-skeletal healthcare, announced a multi-year collaboration with the Indo-UK Institutes of Health (IUIH) that will increase the capacity of India's healthcare infrastructure. The first phase of the collaboration involves the establishment of theZimmer Biomet Institute of India, a 30,000 square foot state-of-the-art medical training and education facility on the campus of King's College Hospital in Amaravati, Andhra Pradesh. The Institute will help improve the delivery of and access to high-quality healthcare across India by training more than 1,000 orthopaedic surgeons annually on the latest orthopaedic procedures and the safe and effective use of Zimmer Biomet medical technologies. IUIH, in partnership with UK's National Health Service (NHS) and its leading teaching institutions, plans to build 11 'Medicities' with Amaravati's King's College Hospital being the first, in major states across India. Each Medicity campus will include a 1,000-bed hospital, a medical and nursing school, student and staff housing, hotel facilities, and a third-party-run training and education center focused on a designated medical specialty. Zimmer Biomet estimates investing more than $5 million in the King's College Hospital training and education center over three years, beginning in 2017. Zimmer Biomet serves approximately 50,000 patients in India each year, and through its Zimmer Biomet Institute, has successfully trained nearly 7,000 surgeons, medical and nursing students, and paramedics since its launch in 2008. The IUIH's Medicities program aims to establish 11 hospitals with medical colleges, with a total bed capacity of 11,000 and a throughput of between 1,100 and 1,650 medical students per year. The initiative is backed by the UK and Indian prime ministers and governmental institutions, including UK Trade and Investment (UKTI) and Healthcare UK. The King's College Hospital in Amaravati is scheduled to break ground later this year, and is expected to create jobs for 2,500 nurses and 500 physicians. ]]> <![CDATA[China's Fosun pharma to buy Gland pharma ]]> https://biospectrumindia.com/news/95/8143/chinas-fosun-pharma-to-buy-gland-pharma-.html https://biospectrumindia.com/news/95/8143/chinas-fosun-pharma-to-buy-gland-pharma-.html Wed, 27 Jul 2016 12:37:00 +0530 In a first, China's Fosun Pharmaceutical Group is all set to acquire 96 reports stake in Gland Pharma for $1.3-1.5 billion, a leading daily reported. Hyderabad-based Gland Pharma is backed by global private equity firm KKR & Co. The deal will be announced in a day, said the first person close to the development. The two companies will ink an agreement where Fosun will acquire 96 percent of the stake including shares held by founders of Gland Pharma Mr Ravi Penmetsa and family and private equity giant, KKR & Co LP. However reports also suggested that Gland will initially buy 86 percent of the company while Mr Penmetsa may retain a 10 percent stake. The deal may need FIPB approval. Established in 1978, Gland Pharma develops and manufactures generic injectables, primarily for the US market. It also sells its products in India and other semi-regulated markets. Its manufacturing facilities are approved by the US and UK drug regulators. Shanghai Fosun Pharmaceutical (Group) Co, is part of FOsun International group, the flagship company of billionaire Guo Guangchang, one of China's best-known entrepreneurs. With wide presence across business segments in the healthcare chain - drug manufacturing, distribution and retail to high-end diagnostics and medical devices, Shanghai-based Fosun Pharma has grown rapidly through acquisitions. The company has a Fosun's portfolio covers liver diseases, diabetes, tuberculosis and diagnostic products, and it's also the leading provider of anti-malaria medicines globally. This agreement, on closure, will be first significantly large foreign direct investment (FDI) from China in Indian manufacturing. The agreement will, further, will aid the Chinese firm to expand its research and manufacturing capacity under 'Make in India' program. The deal will have to get regulatory approvals from Indian authorities. As this will be a controlling acquisition by a Chinese player, the deal will undergo strict regulatory scrutiny. Shanghai Fosun Pharmaceutical ended 2015 with a revenue of $1.9 billion. Its market value was $8.3 billion as of 31 December 2015, as per reports. ]]> <![CDATA[Saudi Arabia's pharma market set to hit $6 bn by 2020 ]]> https://biospectrumindia.com/features/95/8034/saudi-arabias-pharma-market-set-to-hit-6-bn-by-2020-.html https://biospectrumindia.com/features/95/8034/saudi-arabias-pharma-market-set-to-hit-6-bn-by-2020-.html Tue, 26 Jul 2016 16:44:31 +0530 The pharmaceutical market in Saudi Arabia is set to grow from $4.5 billion in 2015 to $6 billion by 2020, representing a compound annual growth rate (CAGR) of 7.4%, according to research and consulting firm GlobalData. The company's latest report states that Saudi Arabia is one of the largest pharmaceutical markets in the Middle East, and its impressive expansion can be attributed to a growing population, rising wealth levels, and demand for patented pharmaceutical products. Mr Adam Dion, GlobalData's Senior Analyst covering Industry Dynamics, explains: "Due to the increase of chronic diseases and Saudi Arabia's rising wealth, there is a huge demand for patented products, representing a significant opportunity for market players. Indeed, this has spurred multi-national companies to set up manufacturing plants in Saudi Arabia, either independently or through joint ventures." Saudi Arabia is planning one of the largest healthcare expansions in the world, with the Ministry of Health planning to spend $18.5 billion annually over the next 10 years. Its investment plan is to improve domestic manufacturing of medical devices and pharmaceuticals, which would create job opportunities and enhance the country's knowledge pool. In order to meet demand, strong private sector partnerships would need to be established. Mr Dion continues: "Domestic pharmaceutical manufacturers, which account for only 18% of the market at present, face challenges from the increasing prevalence of low-cost generics and the entrance of global pharma giants such as GlaxoSmithKline, Pfizer, Astellas, and Sanofi. "Domestic manufacturing companies need to focus more on their marketing and sales, and create beneficial partnerships with multi-national companies through joint ventures, acquisitions and license agreements." GlobalData's report also states that government expenditure on health services and social development was $20.8 billion in 2015, an increase of 10.1% over 2014. This was directed towards the construction of new hospitals and reference laboratories for blood banks, medical centers and polyclinics, as well as social development projects, such as sport clubs and rehabilitation centers. "The government's plans to improve the quality of healthcare services across Saudi Arabia offer ample opportunity for small and medium enterprises across the healthcare sector by developing infrastructure in order to attract foreign investment," Mr Dion concludes. ]]> <![CDATA[Vietnamese pharma to reach $6.6 bn by 2020]]> https://biospectrumindia.com/features/95/8033/vietnamese-pharma-to-reach-6-6-bn-by-2020.html https://biospectrumindia.com/features/95/8033/vietnamese-pharma-to-reach-6-6-bn-by-2020.html Tue, 26 Jul 2016 16:19:16 +0530 The company's latest report states that the increasing elderly population, widespread preference for imported branded drugs, rising government support for the healthcare sector and the impending gains from the Trans-Pacific Partnership (TPP) will be the main drivers of growth for the Vietnamese pharmaceutical market during the forecast period. Vietnam signed the TPP, a trade agreement between 12 countries, on February 4, 2016. It is expected that, once implemented, tariffs on pharmaceutical imports will fall to 0%, and patents on foreign pharmaceutical companies' drugs will be extended from five to 10 years. While the Vietnamese market is seen as attractive for pharmaceutical companies, drug prices are high compared with average incomes, which may hinder patient access to medicine. However, foreign pharmaceutical companies are able to generate more revenue not only due to patent protection, but also because locals believe imported drugs are much more effective and tend to prefer them over generics. Domestic pharmaceutical companies focus mainly on generic drugs, with very low expenditure on R&D. This restricts the scope of domestic companies' operations, forcing them to establish themselves either within Vietnam or through exports. At present, the five leading pharmaceutical companies in Vietnam are Sanofi, Hau Giang Pharmaceuticals (DHG Pharmaceuticals), Imexpharm, Traphaco and Domesco. GlobalData's report also states that the Drug Administration of Vietnam issues a new drug registration within 180 days of submission of the application, which is similar to the time it takes in other members of the Association of Southeast Asian Nations but is much shorter than in developed countries, including the US and the UK. Despite this, the application procedure is time-consuming, partly because the documents for biologics and vaccines must be submitted in Vietnamese. The minimum requirement for obtaining approval for a pharmaceutical manufacturing facility in Vietnam is a Good Manufacturing Practice (GMP) certification. The legal documents required to import drugs are the Certificate of Pharmaceutical Product, the Certificate of Free Sale, and the GMP, or certification under an equivalent standard. ]]> <![CDATA[Granules to acquire 12.5% stake in USpharma ]]> https://biospectrumindia.com/news/95/7963/granules-to-acquire-12-5-stake-in-uspharma-.html https://biospectrumindia.com/news/95/7963/granules-to-acquire-12-5-stake-in-uspharma-.html Fri, 22 Jul 2016 16:34:55 +0530 Granules India Ltd has announced that its wholly-owned subsidiary Granules Pharmaceuticals Inc. has entered into an agreement to acquire 12.5 percent stake in the US-based drug maker USpharma Inc. Financial details of the transaction were not disclosed. USpharma is a development-stage pharmaceutical company specializing in research, development and manufacture of high entry-barrier generic pharmaceuticals, including controlled-release, controlled-substance and patent-challenge products. The firm, in collaboration with manufacturing partners, had submitted five abbreviated new drug applications (ANDA) with para-IV certifications, out of which four ANDAs have already been out-licensed to Granules exclusively. USpharma has formulation, development and manufacturing facilities in Philadelphia and Mumbai, and an analytical laboratory in Kansas City. "The agreement with USpharma complements our internal product development programme, and expands our product portfolio by leveraging external product development capabilities," said Mr Krishna Prasad Chigurupati, chairman and managing director of Granules India. "The successful development of limited-competition products by USpharma provides further long-term growth for the company," Mr Chigurupati added. ]]> <![CDATA[Dr Reddy's recalls 9,330 bottles of Sirolimus tablets in the US ]]> https://biospectrumindia.com/news/95/7965/dr-reddys-recalls-9330-bottles-of-sirolimus-tablets-in-the-us-.html https://biospectrumindia.com/news/95/7965/dr-reddys-recalls-9330-bottles-of-sirolimus-tablets-in-the-us-.html Fri, 22 Jul 2016 16:31:55 +0530 According to the latest Enforcement Report of United States Food and Drug Administration (USFDA), Dr Reddy's US arm Dr Reddy's Laboratories Inc is recalling 9,330 bottles of Sirolimus tablets, 1 mg on account of failed impurities. As per the report, the reason for recall is "failed impurities/degradation: out of specification result for impurity secorapamycin." The voluntary nationwide ongoing recall is a class III recall. As per USFDA a class III recall is initiated in a "situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences." The tablets were manufactured by Dr Reddy's Laboratories at its Visakhapatnam plant. Sirolimus tablets are indicated for the prevention of organ rejection in patients aged 13 years or older receiving renal transplants. ]]> <![CDATA[MSF report shows price of older HIV drugs decreasing]]> https://biospectrumindia.com/news/95/7716/msf-report-shows-price-of-older-hiv-drugs-decreasing.html https://biospectrumindia.com/news/95/7716/msf-report-shows-price-of-older-hiv-drugs-decreasing.html Fri, 22 Jul 2016 15:48:04 +0530 The international medical humanitarian organization Doctors Without Borders/MÃ©decins Sans FrontiÃ¨res (MSF) released the 18th edition of its HIV drug pricing report, Untangling the Web of Antiretroviral Price Reductions, at the International AIDS Conference in Durban, South Africa. The report finds that prices of older HIV drugs continue to decline, while newer drugs remain largely priced out of reach of the people who need them most. This is in large part because pharmaceutical corporations maintain monopolies that block price-lowering generic competition. Today, the lowest available price for a quality-assured, World Health Organization-recommended first-line one-pill-a-day combination is $100 per person per year (tenofovir/emtricitabine/efavirenz). This is a decrease of 26 percent since MSF last recorded the lowest price for first-line treatment at $136 in 2014. For a WHO-recommended second-line regimen, the lowest available price is now $286 per person per year (zidovudine/lamivudine + atazanavir/ritonavir)-an 11 percent decrease from $322 two years ago. These prices continue to fall as a result of robust competition among generics manufacturers in key producing countries, primarily India. But the price of newer drugs-needed for people who have run out of other HIV treatment options-remain high, largely because of patent monopolies held by drug corporations. The lowest price for salvage treatment today is $1,859 per person per year (raltegravir + darunavir/ritonavir + etravirine). This is more than 18 times the price of first-line therapy, and more than six times the price of today's most affordable second-line combination. The price for this combination has come down only by seven percent, from $2,006 per year in 2014. These are the lowest global prices, but many countries, especially 'middle-income' countries, pay much higher prices for these medicines because pharmaceutical patents block them from using generics. "We have to be able to afford the newer HIV drug combinations that people will need over time, or else they will have no other options," said Dr Vivian Cox, Medical Referent for MSF's Eshowe project in South Africa "We need to be shouting about this now to make sure we don't end up with another treatment crisis like the one we faced over a decade ago, when life-saving medicines were simply priced out of reach for millions of people who needed them." While today the number of people who require salvage therapy is still relatively small in developing countries, the increased use of gold-standard viral load treatment monitoring is helping identify more people who are failing on their first- or second-line treatment and need to be switched to another set of medicines. Already in MSF's HIV programs, the number of people having moved to second-line therapy has almost doubled since 2013. India, the world's main producer of affordable HIV medicines, is often called the "pharmacy of the developing world." More than 97 percent of the HIV medicines MSF uses in its treatment programs are generic medicines from India. India's patent law sets a high bar for what deserves a patent. This allows robust competition among generic producers, which has driven down first-line HIV treatment prices by 99 percent -- from $10,000 per person per year in 2000, to $100 today. But India is facing immense pressure to roll back its pro-health patent policies-which put people's lives over corporate profits-especially from the United States, backed by its pharmaceutical corporation lobby. Other countries, such as the EU, along with Japan and South Korea, are preparing or actively pursuing trade agreements with India that would restrict the country's production of affordable medicines in the future. Should India be forced to change its policies for these trade agreements, it could pose a serious threat to affordable medicines production in India. "India is under massive pressure to turn off its tap of affordable medicines, which are a lifeline to millions of people not only in India, but across the developing world," said Ms Leena Menghaney, South Asia Head of MSF's Access Campaign. "If India doesn't stand strong against the pharmaceutical corporations and governments that are pushing for change in the country's patent law and policies, people around the world will face a crisis in access to medicines in the future. ]]> <![CDATA[Sun Pharma bags FDA approval for generic Crestor]]> https://biospectrumindia.com/news/95/6673/sun-pharma-bags-fda-approval-for-generic-crestor.html https://biospectrumindia.com/news/95/6673/sun-pharma-bags-fda-approval-for-generic-crestor.html Thu, 21 Jul 2016 10:35:34 +0530 Sun Pharma has announced that one of its subsidiaries has received final approval from US FDA for its Abbreviated New Drug Application (ANDA) for generic version of Crestor, Rosuvastatin Calcium tablets 5 mg (base), 10mg (base), 20 mg (base) and 40 mg (base). These Rosuvastatin Calcium tablets are therapeutic equivalents of IPR Pharmaceuticals, Inc.'s Crestor tablets. As per IMS MAT May 2016, these tablets have annual sales of approximately $6.8 billion inthe US. These tablets are indicated for the treatment of adult patients with Hypertriglyceridemia, Primary Dysbetalipoproteinemia (Type III Hyperlipoproteinemia) and adult patients with Homozygous Familial Hypercholesterolemia. ]]> <![CDATA[Book on patient stories on MDR-TB launched]]> https://biospectrumindia.com/news/95/8037/book-on-patient-stories-on-mdr-tb-launched.html https://biospectrumindia.com/news/95/8037/book-on-patient-stories-on-mdr-tb-launched.html Wed, 20 Jul 2016 16:30:17 +0530 Lilly MDR-TB partnership announced the release of a first-of-its-kind compilation of patient stories with insights on the disease burden and health implications of TB in India. The book is authored by Mr Chapal Mehra, a well-known TB activist and provides a platform for people to share the stories of their struggle against the disease. For many years, tuberculosis, and more recently MDR-TB, have imposed a significant physical, emotional and economic burden on patients, their families and the society. As policies are designed to prevent and treat the disease, it becomes crucial to understand the needs, challenges and experiences of TB patients in the country. The patient case book describes the grit and determination that the battle against TB requires of patients, particularly those who suffer from MDR-TB. Written from the perspective of a patient, the book seeks to break common stereotypes and misconceptions surrounding the disease. These stories successfully capture the sense of struggle and triumph underlying every survivor's story in their battle against the disease. Speaking about the book, Mr Chapal Mehra said, "I am grateful that my humble attempt to throw more light on the struggles of TB patients will have the chance to reach more people. It is my hope that this book will empower more TB patients to speak out, have their voices heard and increase awareness that TB is a curable disease." The most commonly shared patient experience is the need for guidance and support to adhere to the full treatment protocol. The lack of a supportive environment as well as other physical and economic challenges often force patients to abandon treatment. This leads to patients developing drug resistant TB. Other issues that contribute to developing MDR-TB are delayed diagnosis and treatment, severe side-effects and societal stigma. Mr Anant Garg, Director, Corporate Affairs, Pricing, Reimbursement & Access, Eli Lilly, said, "We realized that there are not many platforms where people who have gone through this difficult journey can share personal insights and articulate the real challenges and issues that they face. This book is our little attempt in that direction and will hopefully help all the stakeholders relate better to those who have been impacted, and reflect on how to contribute in our own capacity to make life better for them." The book covers the multiple social, economic and cultural determinants that come into play in tackling TB and illustrate how awareness, empowerment, family support and social stigma are possibly the most decisive factors in determining a TB patient's ability to fight this disease. The book will be distributed among state TB officials, civil society organizations and partners working in the space of tuberculosis. ]]> <![CDATA[Glenmark receives ANDA approval for Rosuvastatin Calcium tablets]]> https://biospectrumindia.com/news/95/8229/glenmark-receives-anda-approval-for-rosuvastatin-calcium-tablets.html https://biospectrumindia.com/news/95/8229/glenmark-receives-anda-approval-for-rosuvastatin-calcium-tablets.html Wed, 20 Jul 2016 16:28:42 +0530 Glenmark Pharmaceuticals USA (Glenmark), has been granted final approval by the United States Food & Drug Administration (USFDA) for Rosuvastatin Calcium Tablets, 5 mg (base), 10 mg (base), 20 mg (base), and 40 mg (base), the generic version of Crestor Tablets, 5 mg, 10 mg, 20 mg, and 40 mg of IPR Pharmaceuticals (IPR). According to IMS Health sales data for the 12 month period ending May 2016, the Rosuvastatin Calcium Tablets, 5 mg (base), 10 mg (base), 20 mg (base), and 40 mg (base) market achieved annual sales of approximately $6.78 billion. Glenmark's current portfolio consists of 115 products authorized for distribution in the US marketplace and 61 ANDA's pending approval with the USFDA. In addition to these internal filings, Glenmark continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio. ]]> <![CDATA[Sanofi India Expands Diabetes Portfolio]]> https://biospectrumindia.com/news/95/7745/sanofi-india-expands-diabetes-portfolio.html https://biospectrumindia.com/news/95/7745/sanofi-india-expands-diabetes-portfolio.html Wed, 20 Jul 2016 09:59:46 +0530 Sanofi-Synthelabo (India) announced the launch of two drugs for type 2 diabetes patients in India: LYXUMIA(lixisenatide) and ZEMIGLO(gemigliptin). LYXUMIA is a once daily, non-insulin injectable drug and ZEMIGLO is a once daily, oral tablet. Mr N. Rajaram, Country Head & General Manager - Pharmaceutical Operations said, "The challenge people living with diabetes face today is to keep their glucose levels under control; nearly 50 percent of people living with diabetes remain uncontrolled. Sanofi India is proud of its strong legacy in diabetes management. We have a diversified portfolio of oral and insulin therapies, including Lantus and Amaryl that have been supporting people in diabetes management for over a decade. The launch of two additions to Sanofi India portfolio - Lyxumia and Zemiglo, is our step forward in developing new solutions for people with type 2 diabetes. It is also a testament to Sanofi India's commitment to help to address the current treatment gaps in our country. We are excited to bring these molecules to India." Sanofi India's integrated portfolio of marketed products provides treatment, monitoring and support at every stage of the diabetes journey. Lyxumia (lixisenatide) and Zemiglo (gemigliptin) are critical elements of this portfolio. Dr Mubarak Naqvi, Head - Medical Affairs, India & South Asia said, "The development and clinical use of Dipeptidyl Peptidase-4 (DPP-4) inhibitors and Glucagon-Like Peptide-1 (GLP-1) receptor agonists are relatively recent advancements in the management of type 2 diabetes. These class of drugs will help people living with diabetes reduce HbA1c and maintain their targets, with minimal chances of hypoglycemia. Lyxumia has demonstrated an added benefit of weight reduction in Type 2 diabetes patients." He added, "Lyxumia is a right fitment for adults with type 2 diabetes mellitus to achieve glycemic control in combination with oral glucose-lowering medicinal products and/or basal insulin like Lantus, when these alone, do not provide adequate glycemic control. It targets the meal-time increase in blood sugar and helps patients reach their treatment targets. In addition, Gliptins are increasingly being used for people with diabetes because of their low risk of hypoglycemia (low blood sugar), and overall safety and efficacy. Zemiglo, our gliptin has shown these benefits in Indian people living with diabetes." Lyxumia is currently approved in over 70 countries worldwide for the treatment of type 2 diabetes, with commercial launches in most EU countries, Japan, Brazil, Mexico and other markets. It has been filed in the US for approvals. Zemiglo has been approved in South Korea in 2012 and already has over three years of clinical experience. It is now available in India. Lyxumia and Zemilgo are prescription drugs and are to be taken only when prescribed by the doctor. ]]> <![CDATA[SPARC licenses ELEPSIA XRTM(Levetiracetam ER Tablets) to Sun Pharma]]> https://biospectrumindia.com/news/95/8201/sparc-licenses-elepsia-xrtmlevetiracetam-er-tablets-to-sun-pharma.html https://biospectrumindia.com/news/95/8201/sparc-licenses-elepsia-xrtmlevetiracetam-er-tablets-to-sun-pharma.html Tue, 19 Jul 2016 10:57:49 +0530 Sun Pharma Advanced Research Company Ltd. and Sun Pharma announced a licensing arrangement for SPARC's ELEPSIA XRTM (Levetiracetam Extended Release tablets). As per the agreement, SPARC will license ELEPSIA XRTM (Levetiracetam Extended Release tablets) to a wholly-owned subsidiary of Sun Pharma for the US market. SPARC will receive an up-front payment of US$10 million from Sun Pharma. It is also eligible for certain additional milestone payments and defined royalties linked to any future sales of ELEPSIA XRTM. ELEPSIA XRTM was approved by the USFDA in March 2015. However, in September 2015, SPARC received a complete response letter (CRL) from the USFDA rescinding its earlier approval, citing that the compliance status of the manufacturing facility viz., Halol site of Sun Pharma was not acceptable on the date of approval. Sun Pharma has undertaken a detailed remediation at Halol for restoring cGMP compliance status for the site. Anil Raghavan, CEO, SPARC said, "The licensing of ELEPSIA XRTM is a step ahead in our desire to make it available for thousands of epilepsy patients taking multiple pills of Levetiracetam every day. ELEPSIA XRTM is designed as a novel once-a-day formulation of Levetiracetam using SPARC's proprietary Wrap Matrix technology. It is designed to reduce pill burden and help improve convenience and compliance in these patients. If and when the USFDA reapproves the ELEPSIA XRTM application, Sun harma's significant US presence will help SPARC in commercializing this important product for patients in the US market." Commenting on the in-licensing, Kirti Ganorkar, Senior Vice President, Business Development, Sun Pharma said, "The in-licensing of ELEPSIA XRTM will facilitate Sun Pharma's anticipated entry into the proprietary CNS segment in the US. This is a part of Sun Pharma's strategy, to strengthen its presence in the US specialty segment through its newly created Sun Neurosciences business unit. We believe that SPARC's Wrap MatrixTM technology will help in differentiating ELEPSIA XRTM amongst other competing products." ]]> <![CDATA[Dr Reddy's launch Omeprazole and Sodium bicarbonate capsules in US]]> https://biospectrumindia.com/news/95/8200/dr-reddys-launch-omeprazole-and-sodium-bicarbonate-capsules-in-us.html https://biospectrumindia.com/news/95/8200/dr-reddys-launch-omeprazole-and-sodium-bicarbonate-capsules-in-us.html Tue, 19 Jul 2016 10:54:48 +0530 Dr Reddy's Laboratories announced that it has launched Omeprazole and Sodium bicarbonate capsules, 20mg/1100mg and 40mg/1100mg, a therapeutic equivalent generic version of Zegerid (omeprazole/sodium bicarbonate) capsules in the United States market, having been approved by the US Food & Drug Administration (USFDA). The Zegerid brand and generic had US sales of approximately $306.7 million MAT for the most recent twelve months ending in May 2016 according to IMS Health. Dr Reddy's Omeprazole and sodium bicarbonate capsules 20 mg/1100 mg and 40 mg/1100 mg are available in bottle count size of 30. Zegerid is a registered trademark of Santarus, Inc. a wholly owned subsidiary of Salix Pharmaceuticals. ]]> <![CDATA[ UPS expands clinical trial logistics capabilities]]> https://biospectrumindia.com/news/95/8060/-ups-expands-clinical-trial-logistics-capabilities.html https://biospectrumindia.com/news/95/8060/-ups-expands-clinical-trial-logistics-capabilities.html Tue, 19 Jul 2016 10:53:24 +0530 UPS announced a significant global expansion of its healthcare-specific capabilities to support clinical trials. UPS's investments in a range of specialized solutions will help pharmaceutical companies and clinical investigators move sensitive materials and specimens globally, particularly in and out of complex geographies. Building on its expansive, integrated network, UPS has made improvements specifically targeted to meet strict clinical trial logistics requirements. Enhancements include: development of an easy-to-use shipping system for clinical investigator sites; an expansion of the healthcare control tower network, package intercept and re-icing capabilities; and upgraded operations to move temperature-sensitive biological specimens in and out of more than 60 countries more efficiently. Making these investments, together with utilizing an established network of local specialty couriers, helps UPS serve the clinical trial research community by providing efficiency in the transport of specimens without sacrificing service. Given the global reach of clinical studies, streamlined logistics are an increasingly important component of successful trials. UPS is well-poised to serve this expanding market, with capabilities that cover many geographies, from San Francisco to Sao Paulo, or Bangkok to Berlin. "As innovation in the biopharma industry evolves - and with the emergence of personalized therapies and growing direct-to-patient trends - research and development activity will only increase around the world. Our cost-effective portfolio streamlines logistics for clinical trials into one global network across sometimes remote, hard-to-reach locations," said Mr Habib N'Konou, UPS senior operations director for clinical trials. "With drug research taking years at a cost in the billions, a product loss or damage, including falling out of temperature range, could mean a costly setback. Our recent improvements to our network will reduce product loss or damage." UPS mitigates risks by employing world-class air freight and small package solutions for Investigational Medicinal Products, specimen kits, ancillary supplies, and medical devices to and from investigator sites, contract research organizations, and diagnostic centers. Its customs brokerage team, one of the world's largest, helps shippers navigate international regulations and avoid costly delays. "Improved health outcomes through sophisticated drugs and vaccines starts with successful clinical trials," said Mr Geoff Light, UPS vice president of global healthcare strategy. "Optimized logistics is an integral component of medical research and development, and our goal is to help clinical investigators reach any part of the world with maximum efficiency. We will continue to invest in the right global solutions with the aim of becoming the preeminent leader in biological specimen transportation." ]]> <![CDATA[WHO felicitates India for yaws, maternal and neonatal tetanus elimination]]> https://biospectrumindia.com/news/95/7822/who-felicitates-india-for-yaws-maternal-and-neonatal-tetanus-elimination.html https://biospectrumindia.com/news/95/7822/who-felicitates-india-for-yaws-maternal-and-neonatal-tetanus-elimination.html Fri, 15 Jul 2016 15:08:24 +0530 "India's focused approach on making maternal and newborn care accessible to all and addressing health care equity more generally has made these remarkable successes possible. These victories are not only India's but all of humanity's as the country accounts for approximately one-sixth of the world's population," said Dr Poonam Khetrapal Singh, Regional Director, World Health Organization South-East Asia Region, said after presenting the certificates to the Minister. In May this year, WHO certified India yaws-free after a team of experts verified interruption of disease transmission in the country. India is the first country under the 2012 WHO neglected tropical diseases (NTD) roadmap to eliminate yaws, a disease known to affect the most underserved population. It is said, 'where the road ends, yaws begins'. "Highly targeted awareness and early treatment campaigns in vulnerable communities enabled treatment of yaws cases and interruption of disease transmission," Dr Khetrapal Singh said, commending India's capacity and commitment to eliminating NTDs, which serves as an example to other countries. The Regional Director described India's achievement of maternal and neonatal tetanus elimination (MNTE) as a momentous public health feat, as until a few decades ago the country reported 150 000 to 200 000 neonatal tetanus cases annually. Reducing maternal and neonatal tetanus to less than one case per 1 000 live births in all 675 districts demonstrates India's strong commitment and leadership that helped improve access to immunization, antenatal care services and skilled birth attendance in the most vulnerable populations - the poor, the remote and isolated communities. Both yaws and maternal and neonatal tetanus eliminations were achieved using the existing health system and health workforce. Sustained political commitment and clear policies, unified strategies, close supervision and monitoring, tireless efforts of the frontline workers, and invaluable support of partners, particularly for MNTE, were the key factors for these public health feats, Dr Khetrapal Singh said, adding that the lessons learnt from yaws and MNTE should inform the design and implementation of future disease control programs in the country. Both achievements will not only improve the health of marginalized communities, but will also enhance their socio-economic status and contribute to India's wider development, the Regional Director said. After India's success in MNTE, Indonesia was validated for the same in May this year. With this the entire WHO South-East Asia Region has achieved elimination of maternal and neonatal tetanus. WHO SEAR is the second WHO region, after European Region, to achieve MNTE. Indonesia and Timor-Leste are now the only remaining countries with yaws transmission in the WHO South-East Asia Region. ]]> <![CDATA[Biocon's Insulin Glargine launched in Japan]]> https://biospectrumindia.com/news/95/7801/biocons-insulin-glargine-launched-in-japan.html https://biospectrumindia.com/news/95/7801/biocons-insulin-glargine-launched-in-japan.html Fri, 15 Jul 2016 15:08:05 +0530 Insulin Glargine BS Injection Kit (FFP) has been developed & manufactured by Biocon, and is being commercialized by FFP in Japan. The product is a ready-to-use, prefilled disposable pen with 3 ml of 100IU Insulin Glargine. It will provide a high quality, yet affordable, world-class long-acting biosimilar basal Insulin Glargine for patients of diabetes in Japan. There were 7.2 million people with diabetes in Japan in 2015, according to the International Diabetes Federation. The company through its partner aims to capture a significant share of the Japanese Glargine market of USD 144 million, which is the second largest market outside of North America & Europe, and is largely dominated by disposable pens. Biocon's CMD Dr Kiran Mazumdar-Shaw said: "The launch of our biosimilar Insulin Glargine in Japan by our partner, furthers our mission to provide affordable access to high quality biopharmaceuticals for chronic diseases. We believe with FUJIFILM Pharma's commercial network, we will enable access to this world-class, prefilled disposable pen for better diabetes management for patients in Japan." Biocon is recognized as Asia's largest insulins producer and has been committed to affordable diabetes management through rh-Insulin (Insugen) and Insulin Glargine (Basalog) in India and several emerging markets. The company currently has marketing approvals in over 60 countries for rh-Insulin, and in over 20 countries for Insulin Glargine. It is also developing Insulin Glargine for the developed markets outside of Japan in collaboration with Mylan. ]]> <![CDATA[Mr. Neeraj Jain to lead PATH in India]]> https://biospectrumindia.com/news/95/7800/mr-neeraj-jain-to-lead-path-in-india.html https://biospectrumindia.com/news/95/7800/mr-neeraj-jain-to-lead-path-in-india.html Fri, 15 Jul 2016 15:07:50 +0530 I am pleased to welcome Neeraj to PATH, where his impressive background and leadership on water and sanitation, nutrition, and health will be incredible assets to our India country program," said Kathy Cahill, PATH's vice president for International Development. "Over the course of his career, Neeraj has built strong relationships with government agencies and key stakeholders that are critical partners to PATH in India." PATH has worked in India since 1978, improving health and saving lives through creativity and collaboration with local partners. PATH's wide-ranging work has included helping to develop and deploy vaccines, partnering with Indian firms to create low-cost diagnostic tests, improving nutrition, and working with governments and stakeholders to control and treat tuberculosis and encephalitis. PATH's current role in India focuses on bringing technical know-how for improving health to communities across the country-working alongside local companies, nongovernmental organizations, and public-sector partners.Mr. Jain brings to PATH a broad range of leadership and organizational development experience in the public and private sectors. As leader of PATH's India country program, Mr. Jain will oversee partnerships with government officials, commercial firms, and communities to develop and scale up new vaccines, improve the health of mothers and newborns through better nutrition and safer births, and establish a unique public-private partnership to control tuberculosis in the crowded slums of Mumbai. Mr. Jain's career includes more than 27 years of extensive experience in strengthening organizations. His strengths lie in setting up new ventures, organizational development, and market development, and he has provided strategic leadership for change management in organizations across Asia and Europe. Prior to joining PATH, Mr. Jain led WaterAid India through a dynamic phase of transition as its Chief Executive. He was instrumental in the setup of the India Sanitation Coalition as part of the governing committee and heads the Engagement with Central and State Governments Task Force for them. The coalition, launched in June 2015, is leading the sanitation conversations in India by bringing together organizations and individuals to find sustainable solutions for sanitation. Prior to WaterAid India, Mr. Jain was associated with the Children's Investment Fund Foundation, wherein he brought his extensive experience from the corporate sector to work for child development, with a focus on nutrition, early learning, and child survival in the perinatal period. He was also head of the Asia region for Vestergaard Frandsen, a Swiss company that manufactures water purifiers and insecticidal mosquito nets, primarily aimed at increasing the health impact against vector- and water-borne diseases. Mr. Jain holds a graduate degree in Business Studies from Hong Kong Polytechnic University. He completed his post-graduation studies in Business Administration with a major in finance from the Faculty of Management Studies, University of Delhi. ]]> <![CDATA[Afferent acquisition enables Merck enter lucrative Idiopathic Pulmonary Fibrosis market]]> https://biospectrumindia.com/features/95/7578/afferent-acquisition-enables-merck-enter-lucrative-idiopathic-pulmonary-fibrosis-market.html https://biospectrumindia.com/features/95/7578/afferent-acquisition-enables-merck-enter-lucrative-idiopathic-pulmonary-fibrosis-market.html Thu, 14 Jul 2016 16:48:59 +0530 According to the agreement terms, Merck, through a subsidiary, will acquire all outstanding stock of Afferent in exchange for a payment of $500M in cash up front. Afferent shareholders will also be eligible to receive a total of up to an additional $750M in association with the attainment of certain clinical development and commercial milestones for multiple indications and candidates, including AF-219. "AF-219, a selective, non-narcotic, orally-administered P2X3 antagonist, is Afferent's lead candidate, and is currently in Phase II trials in subjects with idiopathic pulmonary fibrosis (IPF) with persistent cough," states Mr Matthew Thaxter, an analyst covering Immunology at GlobalData, a research and consulting firm. Afferent states that 73-86% of IPF patients suffer from chronic cough, and the two currently approved IPF treatments-Genentech's Esbriet (pirfenidone) and Boehringer Ingelheim's Ofev (nintedanib)-do not alleviate any disease-associated symptoms. At the 2016 American Thoracic Society's (ATS) annual conference in May, Afferent presented data from its Phase IIb chronic cough study that showed treatment with AF-219 significantly reduced cough frequency at all doses. The company anticipates commencing a Phase III registration program in early 2017. ]]> <![CDATA[Stanford, Apollo sign MoU to decode cardiovascular risk reduction]]> https://biospectrumindia.com/news/95/7478/stanford-apollo-sign-mou-to-decode-cardiovascular-risk-reduction.html https://biospectrumindia.com/news/95/7478/stanford-apollo-sign-mou-to-decode-cardiovascular-risk-reduction.html Thu, 14 Jul 2016 15:14:28 +0530 Apollo Hospitals announced that it recently signed an MoU with Stanford University for the Stanford South Asian Translational Heart Initiative (SAATHI) related to South Asians and Chronic Disease. Together, both parties will attempt to delve deeper into the causes associated with cardiovascular risk in diabetic and pre-diabetic South Asians. The MoU is the first step towards a long-term partnership that will develop and grow over time. Conceptualized with the overall objective to reduce cardiovascular mortality in South Asians, the study will capture data on pre-diabetes and insulin resistance, help physicians understand early patterns of glycemic imbalance, help them understand epigenetic impact on genetically similar populations, and achieve targeted lifestyle and medical therapy. The collaboration will at a later stage look at moving towards a larger Framingham type study that was developed with the objective of identifying common factors or characteristics contributing to chronic vascular diseases in Massachusetts. Studies have indicated that South Asians have four times higher rate of myocardial infraction (MI) and 40% higher rate of mortality after first MI. A WHO report states that there could be over 100 million diabetics by 2030 and South Asians will have 60% higher diabetes (DM) rates in US. Both the organizations are driven by the same objective of strengthening and broadening research on Non Communicable Diseases (NCD's), while also promoting the need for healthy living. Apollo's rich experience in public health service and research expertise associated with guidance from Stanford will help physicians unravel more details on the NCD conundrum and devise necessary preventive interventions to deal with the same.Apollo Hospitals has already embarked on a journey to promote healthy living in India by actively driving the Total Health initiative in a place called Aragonda in Chittor District of Andhra Pradhesh. The foundation aims to provide holistic health care for the entire community of around 70,000 people across age groups, starting from the birth, through their journey into childhood, adolescence, adulthood and in the latter years of their life. Based on World Health Organization's "STEP" approach, the Aragonda program has covered more than 24,050 people and classified them according to their ten year risk of getting an NCD, into three basic groups of low risk, moderate risk and high risk. A pioneer of modern healthcare, Apollo Hospitals has also conceptualized several other unique initiatives including the SHINE Students Health Initiative, a comprehensive program covering more than 150,000 school children, to promote wellness and preventive health in children. While initiatives like the collaboration with Stanford are aimed at fighting the rising incidences of NCD's, Apollo Hospitals has also been emphasizing on the need to control Communicable Diseases, which is also a growing concern. The WHO emphasizes hand hygiene as the one single practice that can reduce diarrheal morbidity by 30 per cent. Diligently following and executing even minute protocols, such as hand hygiene, is what has helped Apollo Hospitals achieve the distinction of being one of Asia's leading healthcare provider with many complex, yet successful procedures to its credit. In an effort to promote hand hygiene, Apollo Hospitals set the Guinness World Record in Handwashing when 1,711 staff members of Indraprastha Apollo Hospitals, Delhi, took part in the Handwash Relay in the hospital practicing hand washing using the 7-step method. ]]> <![CDATA[Taro CEO Kal Sundaram to Return to Sun Pharma ]]> https://biospectrumindia.com/news/95/7450/taro-ceo-kal-sundaram-to-return-to-sun-pharma-.html https://biospectrumindia.com/news/95/7450/taro-ceo-kal-sundaram-to-return-to-sun-pharma-.html Thu, 14 Jul 2016 10:17:12 +0530 Taro Pharmaceutical Industries has announced that its CEO, Mr Kal Sundaram, has informed Taro's Board of Directors ("Board") of his intention to step down as CEO by the end of the current calendar year. Mr Sundaram will return to India, to assume an executive position at Sun Pharma's global headquarters after the completion of his assignment at Taro at the end of 2016. The Company's Board will conduct a formal process to appoint a CEO to solely focus on Taro. Mr Sundaram will assist the Board with its search, and will remain with Taro through the end of 2016 to ensure a smooth and successful transition for his successor. Commenting on the transition, Mr Dilip Shanghvi, Taro's Chairman said, "On behalf of Taro's entire Board, I want to thank Mr Kal for his many contributions to Taro - providing significant leadership over a challenging period for both the company and the industry, his commitment and dedication to being a driving force behind Taro's strategic direction, and leading the company on a steady and consistent growth path - delivering strong financial and operational performance." Mr Sundaram added, "I am grateful and privileged to be associated with Taro for the past four years as a Board member and three years as CEO. I am also proud of what the Taro team has accomplished during that time. By all measures, the Company has executed very well over the past several years, and as a result, Taro is well positioned for continued growth and success." Mr Sundaram concluded, "I'd like to thank the Board, the executive management team, and Taro's employees for their support throughout the years." ]]> <![CDATA[Can India Dominate the biosimilar market?]]> https://biospectrumindia.com/features/95/8081/can-india-dominate-the-biosimilar-market.html https://biospectrumindia.com/features/95/8081/can-india-dominate-the-biosimilar-market.html Thu, 14 Jul 2016 10:16:24 +0530 Why India is not on the Biosimilars' Radar?Over the last 15 years, Indian Pharmaceutical Industry from having less than 5 percent market share in the US generic market, now has more than 25 percent. But we are yet to see the same advancements in biosimilars.The major bottle-neck for developing biosimilar molecules in India lies in the regulatory challenges, says Dr Sunit Maity, AVP, product development, Theramyt Novobiologics. He added, "Currently BioPharma companies which are developing biosimilars, must receive approval from multiple government agencies, significantly increasing the overall time it will take to bring the product to market. A single-window agency and streamlined approval process will reduce the complexity and encourage the players to develop the biosimilar molecule." Cost and complexity of developing biosimilars poses another challenge. "Biosimilars are large and complex molecules compared to generic pharmaceuticals. Therefore, development and manufacturing of biosimilars is capital intensive and the overall commercialization timelines are 5-7 years, even for launch in domestic market, said Mr KV Subramaniam, president, Reliance Life Sciences. He further added, "Very few generic pharmaceutical companies have capabilities and competencies in R&D and manufacturing of biosimilars." Dr Murtaza Khorakiwala, managing director, Wockhardt provides another view, "The Biosimilar Industry even in the regulated markets is still in a nascent infancy stage and accounts for less than 5% of total Biotechnology Market. However, there are at least 8-10 corporates from India that have significant progress in developing and launching biosimilars in India and emerging markets." Challenges in the manufacturing and development of BiosimilarsBiosimilars manufacturing is capital intensive. The development of biosimilars require extensive preclinical and clinical trials. Thus, the investments required for development and commercialization of these products is quite high. "The investments in biogenerics are very high when compared to conventional generics. The development is itself lengthy and expensive; a successful biosimilar manufacturer has to have good science and manufacturing technology, and the capability to deal with complex regulations," said Mr Rajiv Malik, president, Mylan.The development of biosimilars is also much more challenging due to the greater complexity of biological drugs and the complex manufacturing process. "The major challenges would be significantly higher barriers to entry in terms of - capital investments in scientific / clinical development and manufacturing capacities, evolving regulatory process and still to mature market development strategies and also availability and accessibility of people capability and depth," said Dr Khorakiwala. Another big challenge is on the competency front says Mr Subramaniam.He added, "Very few companies today possess the competencies and capabilities required for development and manufacturing of biosimilars." Dr Maity pointed out that an in-depth understanding of the product and manufacturing process, as well as highly specialized analytical tool are required for development of biosimilar molecule. Cost and Complexity deterrent for Indian companies?The development of biosimilars is much more challenging due to the greater complexity of biological drugs and the high cost of development. Could these be a deterrent for Indian companies? "This is partially true. Small generic pharmaceutical companies may not have wherewithal to develop biosimilars given the capital outlay for commercialization of these molecules. For large companies, it largely depends on their overall strategy and capital allocation for these new class of molecules," said Mr Subramaniam. Cost of conducting clinical trial for biosimilar is a huge burden on the developers. "It has also been deliberated that may be it is better to develop biobetters or novel biologics than biosimilar. It is possible then to launch a product with improved efficacy and immunogenicity profile which can get branded product pricing and it can potentially replace the previous product and will get a major market share," said Dr Maity. Lack of Biotech Boom a barrier?Part of the problem that India has not made significant mark in biosimilar is said to be that, biotechnology is not as well developed in India as chemistry. "It is partially true that capabilities in applied research in biology limited India's growth with regard to biological drug development," said Mr Subramaniam. He continues, "The other key issue was that the generic pharmaceutical industry was 'behind the curve' on this front, as it was always focused on generic pharmaceuticals development, which did not require large capital and had shorter commercialization timelines." However, Dr Maity absolutely disagree with this view. He said, "Indian biotech industry is very well developed otherwise we could not become world leader in vaccine industry." Does India have the expertise to dominate biosmilars industry?"India does have the expertise in biogenerics and recognises the potentials with biosimilars, as was done in the generics industry, and make bio-generic manufacturing an important part of the Make in India movement," Mr Rajiv Malik, president, Mylan. Biotechnology requires specialization and is not as job intensive as compared to pharmaceuticals. "State-of-the-art production facility dedicated to manufacturing of only biotech products are now available with many Indian companies focusing on biosimilars. Indian biotechnology industry is thriving resulting in launch of more than 50 biosimilars till the date," said Dr Khorakiwala. One of the major advantage we have is the significant success and experience in pharmaceutical manufacturing that has been achieved over the last 2 decades. That has brought in rich experience in topics such as GMP manufacturing, documentation practices, scale up, technology transfer and validation."Indian biopharma industry today has all of the essential pre-requisites that are essential for it to emerge as a global manufacturer of economical, safe and efficacious biotech therapeutic products," said Dr Maity. Can India dominate global biosimilars market?"Yes absolutely, if we can become world leader in generics and vaccines then why not in Biosimilar. We need to make a concentrated effort in every level to achieve this," said Dr Maity. Dr Khorakiwala counterfeits the view, "India has immense potential to become one of the key players in the development and manufacture of biosimilar drugs.""There have been many Indian companies who are developing this portfolio & have sold biosimilars in emerging markets. Identifying portfolio with well-laid strategy to develop, manufacture and commercialization of the products in key markets is very essential. The key is investing in research & development," he added. However, Indian companies would have to overcome the challenges mentioned to manufacture high-quality, cost-competitive products. "The companies also would need to invest significantly in talent development specifically in the area of molecular biology, process development and manufacturing of biosimilars," said Mr Subramaniam. "Biosimilars are going to be the next big growth driver in India, playing a major role in offering quality and affordable solutions for disease management," said Mr Malik. New 'Biosimilar Guidelines' of India provides similarity in approach with those in the US and Europe, certainly a step in the right direction. In addition, DBT has launched schemes to promote the development of biosimilars. Given this scenario, India is set to make its mark in the biosimilars market. Some of the Indian companies in biosimilar spaceBiocon's Insulin Glargine Receives Regulatory Approval in Japan and is also gearing up for the US launch. Intas Pharmaceuticals launched INTACEPT, the First Etanercept Biosimilar. It is also expecting US approval of their Neulasta biosimilar soon.Wockhardt is said to be the first in India to launch recombinant human Insulin "Wosulin, recombinant Insulin Glargine "Glaritus" and recombinant human Erythropoietin "Wepox".Hetero launched biosimilar 'Rituximab' under the brand name 'MABALL'.Dr Reddy's launched the first biosimilar filgrastim (G-CSF) in India, first biosimilar MAb (Rituximab) and biosmilar darbepoetin alfa- Cresp.Reliance Life Sciences markets, ReliFeron® (Recombinant Interferon Î±), ReliPoietinTM (Recombinant Erythropoietin), ReliGrast® (Recombinant Granulocyte colony stimulating factor) and MIRelTM (Recombinant Reteplase - tissue plasminogen activator), among others biosimilars in India and overseas market. ]]> <![CDATA[Brexit creates difficulties, opportunities for UK's pharma, medical device industries]]> https://biospectrumindia.com/features/95/7618/brexit-creates-difficulties-opportunities-for-uks-pharma-medical-device-industries.html https://biospectrumindia.com/features/95/7618/brexit-creates-difficulties-opportunities-for-uks-pharma-medical-device-industries.html Wed, 13 Jul 2016 16:30:09 +0530 While the exit of the UK from the European Union (EU) undoubtedly creates significant issues for the UK pharmaceutical and medical device industries in ensuring highly regulated European markets remain open to business, opportunities remain for these sectors to thrive, according to research and consulting firm GlobalData. The company's latest whitepaper states that the vote to leave - also known as Brexit - will have significant consequences for the pharmaceutical and medical device industries in five key areas, namely: regulatory impacts, research and development, access to talent, intellectual property rights, and market access. For manufacturers, the most immediate impact will be on the area of drug and device regulation, as a Brexit vote will be followed by a series of negotiations lasting two years. However, as the UK government has chosen to delay invoking Article 50 until at least the autumn of 2016, and possibly beyond, in principle, this would suggest UK-EU relations would continue as normal until that point. Mr David Shaw, GlobalData's Chief Operating Officer, commented: "Given the time scales that life sciences operate, to suddenly enter a two-year negotiation process doesn't sound like a long time, and that uncertainty makes the monetizing of investments appear more risky." Life science, including pharmaceuticals and medical devices, is a critical element of the UK economy, accounting for over 180,000 jobs and revenue of over $80 billion, according to UK Trade and Investment. 51% of medicinal and pharmaceutical products are exported to the EU. There are numerous ramifications of Brexit for the healthcare sector. For example, the European Medicines Agency (EMA), which is headquartered in the UK, is likely to be swiftly relocated to the EU. There also may be immediate disruption of the regulation of existing medicines, let alone drugs in development. Speaking ahead of the referendum vote, Dr Sean Hu, GlobalData's Senior Vice President & Head of Consulting, said: "If the UK exits the EU, pharma companies could even exclude the UK when assessing commercial potential of drugs due to the much higher access hurdle. Instead, they might choose to focus more on the remaining EU, and treat the UK as an isolated country." Despite the drawbacks of a Brexit vote, GlobalData believes the pharmaceutical industry could still thrive. However, the UK would need to follow a different path from the likes of Switzerland, Canada and Israel, and establish a uniquely British solution. The vote revealed a deeply fractured country, with Scotland resoundingly supporting Remain, Northern Ireland narrowly supporting Remain, and the remainder of the country supporting Brexit. As the major life sciences industry clusters in the UK are in the south east of England, south Wales and the central belt of Scotland, allowing regions of the UK to vary corporation tax could firm up and expand these regions of excellence. At a national level, freed from the EU, a UK government may be able to employ state aid, to greater strategic effect, both as a means to draw in investment, and as a way to shore up the viability of the United Kingdom as a unitary state. However, besides providing a low tax environment, with flexible labor laws, GlobalData believes it is critical that the UK maintains the excellence of its science research and development base, through direct UK government funding, or through participation in external funding programs such as Horizon 2020. ]]> <![CDATA[Biocon Academy collaborates with BITS Pilani]]> https://biospectrumindia.com/news/95/8004/biocon-academy-collaborates-with-bits-pilani.html https://biospectrumindia.com/news/95/8004/biocon-academy-collaborates-with-bits-pilani.html Tue, 12 Jul 2016 16:43:56 +0530 Biocon Academy, a CSR initiative of Biocon, Asia's leading biotechnology company, has opened admission for its 2nd batch of BITS Biocon Certificate Program in Applied Industrial Microbiology (AIM) in collaboration with Birla Institute of Technology & Science (BITS), Pilani. The exclusive program with limited seats is designed to enhance the knowledge and skills of aspiring microbiologists, pharmacy and biotech graduates. The partnership envisions to accelerate learning in the fast growing field of microbiology and boost the employability prospects of students in microbiology and biosciences. The program offers experiential learning by combining the real world insights with class room learning on various aspects of Microbiology through an intensive curriculum delivered by renowned faculty of BITS-Pilani, Biocon Academy and Subject Matter Experts (SMEs) of Biocon. In addition to honing technical skills, this program also sharpens the professional skills of candidates and provides an opportunity for holistic development. The inaugural batch of the program was a great success and we achieved 100% placement in leading Biopharma and Pharma Companies. The admissions are open now till August 16, 2016, and the course will commence from October, 2016 at Bengaluru. Commenting on the program, Ms Bindu Ajit, Program Director, Biocon Academy said, "It's been an enriching experience partnering with BITS, Pilani and successfully completing the first batch of the program with all students getting placed in leading Pharma and Biopharma companies of India. With significant inputs from the experienced faculties and SMEs from Biocon, we have widened the scope of the program. The new BITS Biocon Certificate Program in Applied Industrial Microbiology will additionally include Diagnostic and Food & Beverage Microbiology and will also have case study based discussions...." The 8-week full-time intensive Biocon Academy's 'Applied Industrial Microbiology' program consists of live experiments at the state-of-the-art Quality Control Labs of Biocon to further accentuate the learning of the students. The program includes various modules on: â€¢ Orientation to Applied Industrial Microbiologyâ€¢ Pharmaceutical Microbiology: Quality Systemsâ€¢ Pharmaceutical Microbiology: Environmental Monitoring Program & Bioburden Testingâ€¢ Pharmaceutical Microbiology: Sterility & Endotoxin Testingâ€¢ Determining Microbiological Quality of food & Beverageâ€¢ Diagnostic Microbiology The program is also open to experienced professionals in the world of biosciences who are passionate and eager to enhance their skillsets & knowledge in the field in Microbiology. Total number of seats: 20 Duration of the Program: 8 Weeks Full Time Faculty: Renowned faculty of BITS-Pilani and Subject Matter Experts from BioconCurriculum: The 8-weeks intensive "Applied Industrial Microbiology" program consists of classroom learning, mentorship by experts and live experiments at the state-of-the-art Research and Quality Control Labs of Biocon. Pedagogy: Labs-led / learning by case study methodology Eligibility: â€¢ M.Sc. in Biotech or Microbiology with minimum of 65% or CGPA 6.85 on a scale of 10 (Fresher or Experienced)â€¢ B. Pharm/ M. Pharm with Microbiology as one semester paper with minimum of 65% or CGPA 6.85 on a scale of 10 (Fresher or Experienced) Scholarship by Biocon: 60% of the Program Fee ]]> <![CDATA[Global biosurgery market to reach $7.6 bn by 2022]]> https://biospectrumindia.com/features/95/7204/global-biosurgery-market-to-reach-7-6-bn-by-2022.html https://biospectrumindia.com/features/95/7204/global-biosurgery-market-to-reach-7-6-bn-by-2022.html Tue, 12 Jul 2016 16:31:52 +0530 The global biosurgery market, which covers hemostats, tissue sealants, tissue adhesives, and surgical adhesion barriers, is set to rise from $6 billion in 2015 to $7.6 billion by 2022, representing a steady compound annual growth rate of 3.6%, according to research and consulting firm GlobalData. The company's latest report states that drivers of this growth, which will occur across 15 major markets, include aging populations in many countries, rising disease rates that necessitate a greater number of surgical interventions, and improving healthcare infrastructures in emerging countries that allow for more advanced therapies to be adopted. Mr Shashank Settipalli, GlobalData's Analyst covering Medical Devices, explains: "Emerging markets, particularly large ones such as India and China, have significant untapped potential in expanding the worldwide surgical devices market. As incomes and living standards in these nations continue to rise, a greater segment of the world's population demands better healthcare. "This trend entails greater volumes of procedures being performed in nearly every specialty because more people can afford surgeries that were previously prohibitively expensive, increasing the need for surgical tools and accessories." Another driver is the need to curtail the impact of excessive blood loss, which is second only to head injury as the leading cause of death in trauma cases. In this way, devices such as hemostats, surgical sealant, and tissue adhesives can play an indispensable role in the operative phase of trauma management, and will become more widely used as need increases. Mr Settipalli continues: "As well as increased use of this kind of equipment, higher-cost materials will also see greater uptake. Fibrin biosurgery products, for example, have become adept hemostats, internal surgical sealants, and external tissue adhesives, and their uptake will drive the overall biosurgery market. "Clinicians have known about fibrin's capability as an effective hemostat and sealant for over a century, but major regulatory authorities, such as the FDA, have approved market entry relatively recently. As the number of clinical trials demonstrating fibrin's effectiveness in a wider variety of fields expands, regulatory approval increases for greater indication coverage and companies gain access to a larger base of customers." ]]> <![CDATA[Sun Pharma Launches Gemcitabine InfuSMART]]> https://biospectrumindia.com/news/95/7160/sun-pharma-launches-gemcitabine-infusmart.html https://biospectrumindia.com/news/95/7160/sun-pharma-launches-gemcitabine-infusmart.html Tue, 12 Jul 2016 12:51:51 +0530 As part of its business strategy to build a meaningful and differentiating presence in Global Oncology Therapy market, Sun Pharma has announced the roll-out of Gemcitabine InfuSMART in Europe. InfuSMART is a technology in which oncology products are developed in a Ready-To-Administer (RTA) bag. With the roll-out of Gemcitabine InfuSMART, Sun Pharma becomes world's first pharmaceutical company to manufacture and launch a licensed RTA oncology product. This innovatively differentiated product will have a shelf life of two years. Over the next few months, Sun Pharma will launch Gemcitabine InfuSMART across Netherlands, UK, Spain, Germany, Italy & France. Sun Pharma received regulatory approval to produce Gemcitabine InfuSMART in eight key SKUs. The InfuSMART concept involves dose banding practice whereby, through agreement between prescribers and pharmacists, standardized doses of intravenous cytotoxic drugs are used for ranges (or 'bands') of doses calculated for individual patients. More InfuSMART oncology products are currently in Sun Pharma's pipeline to be rolled out in the future. Commenting on the roll-out of InfuSMART in Europe, Ms Hellen de Kloet, Business Head - Western Europe & ANZ, Sun Pharma said, "Sun Pharma's Gemcitabine InfuSMART ready-to-administer infusion products provide the combined advantage of long stable compounded medicine along with safety. Its ready availability for treatment can make a difference to the healthcare worker and patients. Traditionally such medicines are compounded at hospitals (in-house) or outsourced to compounding pharmacies making it a time-consuming and potentially hazardous process. Launch of InfuSMART will help us remain a meaningful player in the global oncology therapy market by offering differentiating cancer treatment solutions. We believe there are opportunities for us to expand our portfolio of ready-to-administer products across multiple therapies where time and safety are an important element of treatment." The NHS (UK) has been encouraging development of licensed RTA products. It has issued guidelines for hospitals for procuring such medicines. The launch of Gemcitabine InfuSMART offers Sun Pharma a definite first-mover advantage in Europe for cancer treatment. The Gemcitabine InfuSMART RTA infusion bag is developed at Sun Pharma's R&D centre in India. ]]> <![CDATA[Global hip, knee reconstruction market to crawl towards $16.5 bn by 2022]]> https://biospectrumindia.com/features/95/6902/global-hip-knee-reconstruction-market-to-crawl-towards-16-5-bn-by-2022.html https://biospectrumindia.com/features/95/6902/global-hip-knee-reconstruction-market-to-crawl-towards-16-5-bn-by-2022.html Mon, 11 Jul 2016 15:40:43 +0530 The global hip and knee reconstruction market, which encompasses 39 countries and includes primary, partial, and revision hip and knee replacements, as well as hip resurfacing, will expand slowly at a compound annual growth rate of 2.5%, from just under $14 billion in 2015 to $16.46 billion by 2022, according to research and consulting firm GlobalData. The company's latest report states that despite the rising prevalence of patients requiring hip and knee replacements and a trend towards early surgical intervention in younger patients, market growth will be minimal due to a combination of austerity measures in Europe, the medical device excise tax in the US, and deferrals of elective surgeries. Ms Linda Tian, GlobalData's Managing Analyst covering Medical Devices, explains: "While total joint replacement surgery is a highly effective intervention for treating the symptoms of degenerative joint disease, the modest growth in procedure volume will be largely offset by negative pricing pressures and cost-containment measures in healthcare systems. "Current economic conditions are forcing patients to reconsider hip and knee replacements, and the latter in particular can be deferred for long periods following viscosupplementation or the removal of inflamed synovial tissue, debris, and impinging bone spurs, with dramatic symptomatic relief." GlobalData believes economic pressures will be a particular barrier to growth in the US and Europe, resulting in only slight revenue increases in the large joint reconstruction market to 2022. Ms Tian continues: "In Europe, budget constraints stemming from the ongoing Eurozone debt crisis mean the market for joint replacement implants looks gloomy. Indeed, adoption of new products is expected to be slow in Europe as surgeons are inclined to stay with familiar products, as questions remain whether the benefits of premium implants can outweigh their extra costs. "Similar issues can be seen in the US, as the medical device excise tax, which imposes a 2.3% tax on domestic sales of medical devices, puts an immense and costly burden on manufacturers. Some of the ramifications of tax implementation include increased price tags, layoffs, cuts in research and development, and delayed expansion plans, which will adversely affect growth prospects for the hip and knee reconstruction markets during the forecast period." ]]> <![CDATA[Merck buys Brazilian Animal Health Company VallÃ©e S.A.]]> https://biospectrumindia.com/news/95/6852/merck-buys-brazilian-animal-health-company-valle-s-a-.html https://biospectrumindia.com/news/95/6852/merck-buys-brazilian-animal-health-company-valle-s-a-.html Mon, 11 Jul 2016 14:00:59 +0530 Merck Animal Health (known as MSD Animal Health outside the United States and Canada)announced it has executed an agreement to acquire a controlling interest in VallÃ©e S.A., a leading privately-held producer of animal health products in Brazil. VallÃ©e has an extensive portfolio of more than 100 products spanning parasiticides, anti-infectives and vaccines. The company's portfolio includes products for livestock, horses, and companion animals. VallÃ©e was founded with the mission of producing a Foot and Mouth Disease (FMD) vaccine for Brazil and has expanded significantly, with distribution centers in Brazil and operations in Paraguay, Venezuela, Mexico and Bolivia. "Merck Animal Health has a broad portfolio of products to protect against some of the most important pathogens affecting livestock," said Rick DeLuca, president, Merck Animal Health. "We are pleased to complement our portfolio with products from VallÃ©e, which will further strengthen our presence in Latin America and help us respond even more quickly and effectively to the region's needs." The agriculture industry is an important driver of the economy in Latin America. This region contributes 11% of the value of the world food production and a significant number of the cattle in the region are vaccinated with VallÃ©e S.A. vaccines. "As one of the largest producers of protein in the world, Brazil is an important market for us," explains Ralph Cabezas, vice president, Latin America region, Merck Animal Health. "VallÃ©e has been a trusted manufacturing partner in this region for a number of years and we are pleased to offer their products to our customers to help protect animals from diseases." Under terms of the agreement, Merck Animal Health, through a subsidiary, will acquire approximately 93% of the shares of VallÃ©e S.A. at closing, in exchange for a payment of $400 million, based on current exchange rates. This agreement is subject to regulatory review and certain closing conditions. ]]> <![CDATA[Lupin receives EIR from FDA for Goa inspection]]> https://biospectrumindia.com/news/95/6822/lupin-receives-eir-from-fda-for-goa-inspection.html https://biospectrumindia.com/news/95/6822/lupin-receives-eir-from-fda-for-goa-inspection.html Mon, 11 Jul 2016 14:00:43 +0530 Pharma Major Lupin has announced that it has received notification that the inspection carried out by the US FDA in July 2015 at its Goa facility is now closed and the agency has issued an Establishment Inspection Reports (EIR). However, the responses from the March 2016 US FDA inspection and updates thereafter are still under review by the agency. Meanwhile, Lupin also announced that the US FDA inspected its Dabhasa facility from 29th June to 6th July 2016. At the end of the inspection two 483s were issued. Both the observations are minor in nature and corrective and preventive actions were shown to the inspectors during the inspection. The inspection has been classified as Voluntary Action Indicated (VAI). ]]> <![CDATA[Major players in Type 2 Diabetes shifting focus to pricing to maintain market share]]> https://biospectrumindia.com/features/95/5056/major-players-in-type-2-diabetes-shifting-focus-to-pricing-to-maintain-market-share.html https://biospectrumindia.com/features/95/5056/major-players-in-type-2-diabetes-shifting-focus-to-pricing-to-maintain-market-share.html Fri, 08 Jul 2016 18:41:29 +0530 The highly mature type 2 diabetes (T2D) market, which is forecast to be valued at $58.7 billion by 2025, will see pharmaceutical companies prioritizing competitive pricing in order to offset the impact of patent expiries ahead of improving existing products, says research and consulting firm GlobalData. According to the company's report, human insulins and many insulin analogs are currently off patent or will soon lose their patents. The patents for Humulin and Novolin expired in 2001 and 2002, respectively. More recent patent losses include Eli Lill'ys Humalog (insulin lispro) in 2013, Novo Nordisk's NovoLog/NovoRapid (insulin aspart) in 2014, and Sanofi's Lantus (insulin glargine) in 2014-2015. Lantus is already beginning to suffer erosion to the first to market insulin biosimilar, Eli Lilly's Abasaglar (insulin glargine). Dr Jesus Cuaron, GlobalData's Senior Analyst covering Cardiovascular and Metabolic Disorders, explains: "Sanofi, historically a major player in the T2D space, is a good example of a company which has turned its attention to price rather than therapeutic value as the late-stage pipeline becomes saturated with me-too drugs. The company's recently marketed drug Lyxumia (lixisenatide) was launched at a heavy discount to rival glucagon-like peptide-1 receptor agonists (GLP-1RAs), AstraZeneca's Byetta (exenatide) and Novo Nordisk's Victoza (liraglutide). "As Lyxumia is the fourth-to-market GLP-1RA product, with a low level of differentiation in the GLP-1RA space, Sanofi had to offer a competitive price in order to win market share. With health systems in many markets facing cost pressures today, this is likely a strategy that other companies will adopt with their me-too drugs that are in late-stage development." Although a waning factor, major players in the T2D market are also responding to the emergence of insulin biosimilars by offering improvements on existing therapies. Sanofi also recently launched Toujeo (insulin glargine, U300), a superior version of its own product Lantus, in addition to developing a fixed-dose combination of Lantus and its Lyxumia (lixisenatide) in order to protect its franchise. Dr Cuaron notes: "In addition to recently launched Toujeo, Sanofi is developing a biosimilar candidate of its own: SAR-342434. Currently in Phase III trials, SAR-342434 is an insulin lispro biosimilar to Eli Lilly's Humalog. "Overall, GlobalData believes that Novo Nordisk will maintain its lead in the insulin market by 2025, with its several marketed insulin analogs and ultra-rapid acting insulin, FIAsp (faster-acting insulin aspart), which is currently in Phase III trials." ]]> <![CDATA[Sanofi enters into confidentiality agreement with Medivation ]]> https://biospectrumindia.com/news/95/5023/sanofi-enters-into-confidentiality-agreement-with-medivation-.html https://biospectrumindia.com/news/95/5023/sanofi-enters-into-confidentiality-agreement-with-medivation-.html Fri, 08 Jul 2016 18:34:47 +0530 Sanofi indicated that it has been advised by Medivation that Sanofi is being given the same opportunity as others to participate in a process relating to a potential transaction. A dataroom will be opened and management meetings scheduled in the near term. Sanofi also confirmed that on June 27, 2016, it advised Medivation that upon signing a confidentiality agreement and being provided information, Sanofi would increase its offer to $58.00 in cash and $3.00 in the form of a contingent value right (CVR) relating to Talazoparib sales performance. "We are pleased to have the opportunity to engage with Medivation," said Dr Olivier Brandicourt, CEO, Sanofi. "Our willingness to increase our offer is driven by our in-depth analysis of the benefits and value creation potential of a combination. We look forward to discussions with Medivation on a combination which we believe is the most value creating transaction for both companies' shareholders, and would provide Medivation and its employees with an outstanding platform to further grow its oncology franchise." Under the confidentiality agreement, Sanofi has agreed to a customary standstill for six months subject to limited early termination events and has agreed to withdraw its consent solicitation. Sanofi is confident that its due diligence can be quickly completed and that if an agreement is reached on a mutually acceptable transaction, Sanofi can close promptly given that it has received US regulatory clearance, and there would be no financing condition. ]]> <![CDATA[Zydus partners with The Medicines Patent Pool for Hepatitis C Medicine]]> https://biospectrumindia.com/news/95/8022/zydus-partners-with-the-medicines-patent-pool-for-hepatitis-c-medicine.html https://biospectrumindia.com/news/95/8022/zydus-partners-with-the-medicines-patent-pool-for-hepatitis-c-medicine.html Fri, 08 Jul 2016 11:38:33 +0530 Zydus Cadila, a leading global healthcare provider has signed a non-exclusive, royalty free agreement with The Medicines Patent Pool (MPP) for the generic production of Bristol-Myers Squibb's daclatasvir, a novel direct-acting antiviral (DAA) that is proven to help cure multiple genotypes of the Hepatitis C Virus (HCV). The agreement sub-licences Zydus to produce and sell daclatasvir in 112 low and middle income countries. Between 130 and 150 million people worldwide are estimated to have HCV. The vast majority lives in low and middle income countries. The MPP licence allows generic manufacturers to develop fixed-dose combinations that offer the potential to treat all of the six major genotypes of HCV. Daclatasvir, in combination with other DAAs, for example sofosbuvir, produces high cure rates after 12 weeks of treatment, with recent Phase III studies demonstrating that the regimen could cure up to 100% of HCV patients depending on genotype and stage of liver disease. Speaking on the development, Chairman and Managing Director of the Zydus group, Mr Pankaj R Patel said, "We are committed to delivering better therapy outcomes and improving the quality of life of people. We are happy to work together with The Medicines Patent Pool and Bristol-Myers Squibb to serve the cause of healthcare by providing access to new and affordable therapies to the economically disadvantaged communities across the developing countries." ]]> <![CDATA[Sanofi Pasteur signs research agreement for Zika vaccine]]> https://biospectrumindia.com/news/95/5930/sanofi-pasteur-signs-research-agreement-for-zika-vaccine.html https://biospectrumindia.com/news/95/5930/sanofi-pasteur-signs-research-agreement-for-zika-vaccine.html Thu, 07 Jul 2016 16:32:53 +0530 Sanofi and its vaccines global business unit Sanofi Pasteur announced Cooperative Research and Development Agreement with the Walter Reed Army Institute of Research (WRAIR) on the co-development of a Zika vaccine candidate. According to the terms of the agreement, WRAIR will transfer its Zika purified inactivated virus (ZPIV) vaccine technology to Sanofi Pasteur, opening the door for a broader collaboration with the US government. The agreement also includes Sanofi Pasteur's production of clinical material in compliance with current GMP (Good Manufacturing Practices) to support phase II testing, optimization of the upstream process to improve production yields, and characterization of the vaccine product. Sanofi Pasteur will also create a clinical development and regulatory strategy. WRAIR will share data related to the development of immunologic assays designed to measure neutralizing antibody responses following natural infection and vaccination with ZPIV, biologic samples generated during the performance of non-human primate studies, and biologic samples generated during the performance of human safety and immunogenicity studies using ZPIV. WRAIR, the National Institute of Allergy and Infectious Diseases (NIAID)--part of the US National Institutes of Health (NIH), and the Biomedical Advanced Research and Development Authority (BARDA)--part of the Health & Human Services (HHS) Office of the Assistant Secretary of Preparedness and Response--have been coordinating pre-clinical development of the candidate encouraged by new, pre-clinical research conducted by WRAIR and the Beth Israel Deaconess Medical Center[1]. NIAID will sponsor a series of phase 1 ZPIV trials while the technology transfer process is occurring. "In addition to exploring our own vaccine technology used in our new dengue fever vaccine, we are looking at other pathways to get a Zika vaccine into the clinic as soon as possible. Therefore, this exciting collaboration with the WRAIR creates the opportunity to rapidly move forward," said Mr David Loew, Executive Vice President, Head of Sanofi Pasteur. Dr John Shiver, SVP for R&D at Sanofi Pasteur, explained that while simultaneously working on the WRAIR technology, Sanofi Pasteur is performing pre-clinical studies, utilizing a technology previously and successfully developed for both its dengue fever and Japanese encephalitis vaccines. "Zika, Japanese encephalitis, and dengue belong to the same family of viruses (Flavivirus), are transmitted by the same type of mosquito, and share some similarities at the genetic level, and we already licensed vaccines against those flaviviruses." However, he continued, since that pathway will take longer to get a Zika vaccine candidate into the clinic, Sanofi Pasteur has been exploring partnerships with external experts to rapidly advance a vaccine candidate. "We're looking at this from both a short- and long-term perspective, collaborating to get into the clinic quicker to provide a vaccine in response to the current emergency, and adapting our own technology to ensure production capacity of a vaccine for years to come." ]]> <![CDATA[WHO, governments and health agencies commit to advancing global health security]]> https://biospectrumindia.com/news/95/6867/who-governments-and-health-agencies-commit-to-advancing-global-health-security.html https://biospectrumindia.com/news/95/6867/who-governments-and-health-agencies-commit-to-advancing-global-health-security.html Thu, 07 Jul 2016 11:22:20 +0530 The World Health Organization (WHO), governments, financial institutions, development partners, and health agencies from across the world have committed to accelerate strengthening and implementation of capacities required to cope with disease outbreaks and other health emergencies. A significant threat to global health security is the number of national health systems that are weak, fragmented and under-funded. Only about one third of countries in the world have the ability to assess, detect and respond to public health emergencies. Ebola, Zika, yellow fever and other recent outbreaks have exposed these weaknesses at national, regional and international levels. "Fortifying health security in today's world must be a key priority of governments, multilateral agencies, development banks, and non-government organizations the world over. What matters most is maintaining the momentum and turning that into real, tangible results," Dr Poonam Khetrapal Singh, Regional Director, WHO South-East Asia Region said at the end of the three-day meeting on 'Advancing Global Health Security: From Commitments to Actions'. The meeting brought together 250 participants from 52 countries representing 28 different organizations. Speaking at the opening of the event, Dr Matshidiso Moeti, WHO Regional Director for Africa, said, "The bedrock of outbreak and emergency preparedness and response is a functioning, resilient national health system - with the financing, human resources, infrastructure, information and supply management systems capable of detecting and responding to public health events." Renewed commitment to health system strengthening in-line with the International Health Regulations (2005) is needed, especially in vulnerable countries. The true power of health systems is their ability to deliver timely, quality health services to those in need in a comprehensive way and on an adequate scale. These systems are especially important during emergencies, when access to quality essential health services can be severely compromised. The meeting highlighted the critical importance of flexible preparedness planning, community strengthening and engagement, information sharing, strengthening of intersectoral collaboration of national and international partnerships, and the critical role that governments and technical partners play in financing and implementing them. Investing in these systems requires strong ownership and supportive leadership at the highest levels. WHO has also created an open-access web platform called the Strategic Partnership Portal (SPP) to help identify country needs, gaps and partner activities to ensure resources are used more efficiently, without duplication. Training on how to use the SPP, mandated by WHO Member States and supported by health partners, has been rolled out in several high-risk countries in Africa, with planned expansion to other WHO Regions in 2016. ]]> <![CDATA[AZ India collaborates with STEMI India ]]> https://biospectrumindia.com/news/95/5765/az-india-collaborates-with-stemi-india-.html https://biospectrumindia.com/news/95/5765/az-india-collaborates-with-stemi-india-.html Thu, 07 Jul 2016 11:21:37 +0530 AstraZeneca (AZ) Pharma India (AstraZeneca India) has announced a collaboration with STEMI India Charitable Trust, a not-for-profit organization founded by leading cardiologists Dr Thomas Alexander and Dr Ajit S Mullasari (STEMI India). Under the collaboration, STEMI India and AstraZeneca India will work together to emphasize the importance of the "Golden Hour" and appropriate treatment strategies across the country for improving the standard of care for heart attack patients. India has a high burden of coronary artery disease (CAD) in the world; upwards of 3 million heart attacks occur in India every year. One of the gravest complications of CAD is ST-elevation myocardial infarction (STEMI), a life threatening medical emergency that results from a sudden, occlusive thrombus in the coronary artery. If treated within 2 hours of onset of symptoms, much of the damage can be controlled and many more lives saved. Current data suggest that patients are brought in to a hospital only after about 300 minutes. STEMI India along with its industry partners has been leading the efforts towards establishing a STEMI system of care in India through initiatives such as disseminating the latest information on STEMI management, develop a system of care for STEMI care in India, public education on delays in accessing appropriate care and training STEMI teams in hospitals that treat STEMI. To further this initiative, STEMI India concluded the 3rd edition of its Annual Meet on July 2nd and 3rd 2016 in Bengaluru that saw the participation of leading cardiologists, emergency room physicians and paramedics. Over these two days, workshops conducted by experts used lectures, interactive sessions, and case histories to share with participants the recent advances in the management of STEMI. This two-day event reinforced the importance of prompt treatment to ensure that outcomes are optimized and delays are reduced. "ST elevation Myocardial Infarction (STEMI) is one of the most challenging clinical conditions in cardiology since a patient with STEMI requires coordinated action from multiple providers to deliver quick and appropriate care. The objective of STEMI India's annual meet is provide fresh orientation to all caregivers on prompt treatment methods. Training experts are chosen from amongst recognized leaders in STEMI care from around the world," said Dr Thomas Alexander, Founder, STEMI India. Commenting on the partnership, Mr Sanjay Murdeshwar, MD, AstraZeneca India stated, "AstraZeneca India is pleased to partner with STEMI India. This partnership supports our commitment to drive a paradigm shift in the way Acute Coronary Syndrome (ACS) is managed in India through increased awareness of the STEMI India model for managing ACS patients and importance of pre-hospital management of STEMI patients." ]]> <![CDATA[Transasia launches new fully-automated urine chemistry and sediment analyzer]]> https://biospectrumindia.com/news/95/8175/transasia-launches-new-fully-automated-urine-chemistry-and-sediment-analyzer.html https://biospectrumindia.com/news/95/8175/transasia-launches-new-fully-automated-urine-chemistry-and-sediment-analyzer.html Tue, 05 Jul 2016 11:00:02 +0530 Transasia Bio-Medicals announced that it has launched the Laura XL System at the 3rd APPI (Association of Practicing Pathologists - India) Annual Conference 2016 held in June 2016, at JW Marriott Juhu, Mumbai. (Hony.) Brig. Dr. Arvind Lal, (Padma Shri, Chairman & Managing Director, Dr. Lal PathLabs Ltd.), inaugurated this latest innovation from the house of Transasia. Laura XL System is a fully automated urine chemistry and sediment analyzer, which has been developed in-house by Transasia's group entity Erba Lachema, Czech Republic. The launch announcement was also featured in the Mumbai edition of The Indian Express. "Since its inception, Transasia's focus has been on meeting the needs of doctors and patients by providing reliable, affordable and innovative medical diagnostic systems. With the introduction of Laura XL, we have further expanded our product portfolio. Laura XL is a fully automated urine analyzer with 21 classifications using artificial intelligence," said Mr Suresh Vazirani, Chairman & Managing Director, Transasia Bio-Medicals Ltd. "A sophisticated artificial intelligence is responsible for the automatic recognition of sediment on the pictures, resulting in fast and accurate classification and quantitative determination of the sediment content," stated Dr. Suchan Pavel, Global Product Manager, Urine Chemistry & Microbiology, Erba Lachema s.r.o. In addition, Transasia put together three workshops in clinical chemistry, hematology and coagulation, with a complete demonstration of Hb-Vario, Laura XL, XN-L, ECL 412 and EM 200 systems. ]]> <![CDATA[Indus Health Plus receives ISO certification]]> https://biospectrumindia.com/news/95/6468/indus-health-plus-receives-iso-certification.html https://biospectrumindia.com/news/95/6468/indus-health-plus-receives-iso-certification.html Tue, 05 Jul 2016 10:59:28 +0530 This landmark achievement makes Indus Health Plus, one of the few companies in healthcare in Maharashtra to be certified by the new standard, setting new benchmarks in Healthcare industry. Mr Amol Naikawadi, JMD, Indus Health Plus said, "Indus Health Plus has always been at the forefront of knowledge and development. It is a proud moment for all of us as this level of recognition has put our organization nationally renowned. It is a reflection of our belief in offering the best customer services and opens doors for us in the international market." He further added, "We are now in a position to improve efficiency and productivity of processes, people and timely actions to prevent risk." As a part of this certification, quality benchmarks like this will help the company in identifying right delivery partners. ]]> <![CDATA[TNAU scientist Dr N Senthil receives 2016 Best Researcher Award]]> https://biospectrumindia.com/news/95/7848/tnau-scientist-dr-n-senthil-receives-2016-best-researcher-award.html https://biospectrumindia.com/news/95/7848/tnau-scientist-dr-n-senthil-receives-2016-best-researcher-award.html Mon, 04 Jul 2016 12:37:16 +0530 At the 46th Foundation Day celebrations of Tamil Nadu Agricultural University, Dr N Senthil, Project Director, Centre of Innovation, AC&RI, Madurai, and Tamil Nadu Agricultural University, received the Best Researcher Award for the year 2016. Dr Senthil was bestowed with this award for his outstanding contribution to agricultural research, particularly on millets. Dr Senthil was involved in the development of several small millet varieties and wheat varieties suitable for cultivation in Tamil Nadu. He has the expertise and is actively involved in the development of maize varieties though marker assisted breeding for specialty traits like beta carotene. As a plant breeder, Dr Senthil has been involved in millet breeding program for over a decade and his research has led to the development of high yielding minor millet varieties and their release for commercial cultivation to the farmers. To introduce and popularize wheat cultivation in non-traditional areas of Tamil Nadu three new tropical wheat varieties were developed in collaboration with IARI Wellington. Being a molecular breeder the development of improved crop varieties with superior nutritional quality is the major focus of his current research. In line with this objective, in the past five years, he has secured various research projects in maize nutritional traits. His research activities are supported by Department of Biotechnology, Government of India. Dr Senthil and his Japanese co-researcher Professor Takao Komatsuda have together identified the genes responsible for barley's domestication that transformed this once wild food grain into an item for mass consumption. Their research work was published in the journal Cell on July 30, 2015. Professors Komatsuda and Sato along with Indian Professor Senthil have elucidated, for the first time, the genetic basis that led to one of the earliest human cropping activities and eventually to modern agriculture. In their research, two great mysteries about the evolution of wild barley and its transition to modern cultivated barleys were unlocked. A natural mutation in one gene (Btr1) resulted in the establishment of cultivated barley in modern Israel about 10 thousand years ago, while an independent mutation in the other gene (Btr2) occurred later in North west Syria and south east Turkey. As the Head of the department of Biotechnology at AC&RI, Madurai he is working on the establishment of graduate students teaching facility, developing multidisciplinary research project in the focus areas of Southern agro climatic eco systems of Tamil Nadu. Currently he is working as Project Director, Centre of Innovation at AC&RI, Madurai with the responsibility of establishment of Central Instrumentation facility at a cost of Rs 5.30 crore. ]]> <![CDATA[TB Alliance, Takeda partner for Novel TB therapies ]]> https://biospectrumindia.com/news/95/6948/tb-alliance-takeda-partner-for-novel-tb-therapies-.html https://biospectrumindia.com/news/95/6948/tb-alliance-takeda-partner-for-novel-tb-therapies-.html Mon, 04 Jul 2016 12:29:07 +0530 The Global Alliance for TB Drug Developmentand Takeda Pharmaceutical Company Limited has announced that they have entered into an agreement that further explores hits generated from a high-throughput screening program conducted to find novel compounds to improve treatment of tuberculosis (TB). The joint research program is funded through the Global Health Innovative Technology (GHIT) Fund, established for the purpose of promoting research and development of pharmaceutical products, vaccines and diagnostics needed for communicable diseases. In June 2013, TB Alliance and Takeda initiated a program to screen Takeda's library of 20,000 proprietary compounds to identify potential candidates that showed promise to be further developed into new TB treatments. This new collaboration advances the successful hits from the screening program, which was also funded by GHIT Fund. This partnership complements TB Alliance's existing work in advancing the pipeline for new TB drugs. For Takeda, this program with TB Alliance is an excellent opportunity to leverage, as part of Takeda's corporate social responsibility program, the company's drug discovery expertise for communicable diseases, in addition to Takeda's focus on the oncology, gastroenterology and central nervous system therapeutic areas. Today's existing TB treatments are complicated and require a minimum of six months of treatment, imposing a heavy burden on patients, families, and healthcare systems. Treatment for drug-resistant tuberculosis can take two years or longer and is much more expensive and complicated. Given this global health threat, new TB drugs and regimens that are simpler to administer, are of shorter duration, and can overcome drug resistance are urgently needed. The collaboration will leverage both TB Alliance's and Takeda's experience, knowledge and technology to discover and pursue optimal lead compounds for intervention against TB. Through these initiatives, TB Alliance and Takeda aim to contribute to the eradication of TB and improve the health and quality of life for millions of people. ]]> <![CDATA[USFDA completes Strides' facility inspection in Bangalore]]> https://biospectrumindia.com/news/95/8077/usfda-completes-strides-facility-inspection-in-bangalore.html https://biospectrumindia.com/news/95/8077/usfda-completes-strides-facility-inspection-in-bangalore.html Fri, 01 Jul 2016 17:39:17 +0530 The company is a vertically integrated global pharmaceutical company headquartered in Bangalore. The audit was carried out related to a product filed from the new, semi-solids block from where the company has made a series of filings. With the recently closed Establishment Inspection Report (EIR) announced on June 7, 2016, the entire facility is now USFDA compliant. The Oral Dosage facility in Bangalore manufactures oral dosage forms including tablets, capsules (both hard and soft gelatine), ointments and liquids. The manufacturing plant supports important current and future submissions for the US market. The company has global manufacturing foot print with 14 manufacturing facilities spread across 3 continents, including 6 USFDA approved facilities and 8 facilities for the emerging markets. It also has 3 dedicated R&D facilities in India with global filing capabilities, and a strong commercial footprint across 85 countries. ]]> <![CDATA[FDA clears first test to detect specific genetic markers for certain antibiotic-resistant bacteria ]]> https://biospectrumindia.com/news/95/8179/fda-clears-first-test-to-detect-specific-genetic-markers-for-certain-antibiotic-resistant-bacteria-.html https://biospectrumindia.com/news/95/8179/fda-clears-first-test-to-detect-specific-genetic-markers-for-certain-antibiotic-resistant-bacteria-.html Fri, 01 Jul 2016 11:59:36 +0530 The US Food and Drug Administration cleared for marketing the Xpert Carba-R Assay, an infection control aid that tests patient specimens to detect specific genetic markers associated with bacteria that are resistant to Carbapenem antibiotics. Carbapenem antibiotics are widely used in hospitals to treat severe infections. These resistant organisms are commonly referred to as Carbapenem-resistant Enterobacteriaceae, or CRE, and have been reported in almost all states within the US. "By using a specimen taken directly from a patient to test for the presence of genetic markers, hospitals can more quickly identify these dangerous bacteria resistant to certain antibiotics," said Dr Alberto Gutierrez, director of the FDA's Office of In Vitro Diagnostics and Radiological Health within the Center for Devices and Radiological Health. Current methods to identify colonization with CRE or other resistant organisms rely on growing bacteria from fecal material in cultures, which are then subjected to antimicrobial susceptibility testing to determine in vitro susceptibility to antimicrobial agents. Bacterial culture methods and susceptibility testing may take up to four days, and additional testing is often also required to confirm that carbapenemase, an enzyme that inactivates carbapenem antibiotics, is present. The Xpert Carba-R Assay tests specimens directly taken from patients, which are usually obtained by rectal swabs, for the presence of five different genetic markers that are associated with carbapenemase, the enzyme produced by CRE. The Xpert Carba-R Assay is intended as an aid in infection control and can be used in conjunction with other clinical and laboratory findings. Although the Xpert Carba-R Assay tests for the most prevalent carbapenemase genes associated with resistance to carbapenem antibiotics, it does not detect the bacteria, carbapenemase activity or other possible non-enzymatic causes of carbapenem resistance. The Xpert Carba-R Assay tests only for genetic material.The Xpert Carba-R Assay also does not detect all types of carbapenemase genes, and it is important to recover bacteria for accurately tracking the spread of carbapenem resistance. Labs should continue to perform standard bacterial culture in conjunction with the Xpert Carba-R Assay. In addition, concomitant cultures are necessary to recover organisms for epidemiological typing, antimicrobial susceptibility testing, and for confirmatory bacterial identification. According to the Centers for Disease Control and Prevention, CRE infections most commonly occur in people with exposure to health care settings, like hospitals and long-term care facilities. Because of this, these types of infections often occur among patients who are receiving treatment for other serious conditions. Patients whose care requires devices like ventilators, urinary catheters, or intravenous catheters, and patients who are taking long courses of certain antibiotics are among those at risk for CRE infections. CRE are usually resistant to many other antibiotics in addition to carbapenems, and several CRE outbreaks of these highly resistant bacteria have been reported in the US. When bacteria become resistant to carbapenems, few treatment options may remain. Some CRE bacteria have become resistant to almost all available antibiotics and present a significant public health threat. The FDA's decision to provide clearance was based on data from two clinical studies. A prospective study used rectal swabs from 755 patients in hospitals or long-term care facilities to compare results from the Xpert Carba-R Assay with results from reference cultures and automated real-time polymerase chain reaction (PCR) sequencing. A second study designed to test the clinical performance of the Xpert Carba-R Assay used 432 rectal swabs that were artificially prepared with specific concentrations of bacteria containing the genes detected by the test. The results of these studies demonstrated similar performance between the Xpert Carba-R Assay and culture method. The Xpert Carba-R Assay is manufactured by Cepheid, located in Sunnyvale, California, USA. The FDA, an agency within the US Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The Agency also is responsible for the safety and security of our nations' food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products. ]]> <![CDATA[Torrent Pharma acquires manufacturing Unit of Glochem ]]> https://biospectrumindia.com/news/95/7101/torrent-pharma-acquires-manufacturing-unit-of-glochem-.html https://biospectrumindia.com/news/95/7101/torrent-pharma-acquires-manufacturing-unit-of-glochem-.html Fri, 01 Jul 2016 11:58:39 +0530 Torrent Pharma has entered into a binding agreement to acquire the Vizag API manufacturing unit of Hyderabad-based Glochem Industries Limited along with a few Drug Master Files (DMF) as a going concern on slump sale basis. The Company currently has five formulation manufacturing units and with this acquisition it will have 3 API facilities for the regulated markets, in the near future. The API unit approved by the US FDA and the European regulatory authorities is a multi-product facility, with a capacity to manufacture Advance Intermediates & Active Pharmaceutical Ingredients (APIs). This will be beneficial in company's growth trajectory. The acquisition will help Torrent Pharma in vertically integrating its Abbreviated New Drug Application (ANDA) filings in the future. Mr Jinesh Shah, executive director (Operations) at Torrent Pharma said, "Acquisition of this site will further help in backward integration and scale up of Torrent's manufacturing capacity to meet the growing demand from the international markets." The facility located at JNPC Parawada District, Vizag, currently has three blocks for advance Intermediate manufacturing and four blocks for API manufacturing. The facility also has capabilities for on site development, analytical method development, Quality Control laboratory and a Pilot Plant. ]]> <![CDATA[Suven Life secures three Product Patents in Europe and Eurasia ]]> https://biospectrumindia.com/news/95/8426/suven-life-secures-three-product-patents-in-europe-and-eurasia-.html https://biospectrumindia.com/news/95/8426/suven-life-secures-three-product-patents-in-europe-and-eurasia-.html Fri, 01 Jul 2016 11:55:22 +0530 Suven Life Sciences Ltd (Suven) announces today that the grant of one (1) product patent from Europe (2507225) and two (2) product patents from Eurasia (023293 and 023260) corresponding to the New Chemical Entities (NCEs) for the treatment of disorders associated with Neurodegenerative diseases and these Patents are valid through 2029, 2030 and 2031 respectively. The granted claims of the patents are from the mechanism of action include the class of selective 5-HT4 compounds, Alpha4Beta2 and H3 Inverse agonist compounds and are being developed as therapeutic agents and are useful in the treatment of cognitive impairment associated with neurodegenerative disorders like Alzheimer's disease, Attention deficient hyperactivity disorder (ADHD), Huntington's disease, Major Depressive disorder (MDD), Parkinson and Schizophrenia. With these new patents, Suven has a total of twenty one (21) granted patents from Europe and Nineteen (19) granted patents from Eurasia. These granted patents are exclusive intellectual property of Suven and are achieved through the internal discovery research efforts. Products out of these inventions may be out-licensed at various phases of clinical development like at Phase-I or Phase-II. "We are very pleased by the grant of these patents to Suven for our pipeline of molecules in CNS arena that are being developed for cognitive disorders with high unmet medical need with huge market potential globally" says Mr Venkat Jasti, CEO of Suven. ]]> <![CDATA[Ganymed's IMAB362 to bring hope to Gastric Cancer patients]]> https://biospectrumindia.com/features/95/8392/ganymeds-imab362-to-bring-hope-to-gastric-cancer-patients.html https://biospectrumindia.com/features/95/8392/ganymeds-imab362-to-bring-hope-to-gastric-cancer-patients.html Fri, 01 Jul 2016 11:54:19 +0530 New data regarding Ganymed Pharmaceuticals' drug IMAB362, presented at the 2016 American Society of Clinical Oncology (ASCO) Annual Meeting, provides hope for a subset of gastric and gastroesophageal junction adenocarcinoma (gastric cancer) patients with an advanced form of the disease, according to an analyst with research and consulting firm GlobalData. As explored in GlobalData's gastric cancer report, incidences of the disease are set to increase to over 410,000 by 2024 across the eight major markets of the US, France, Germany, Italy, Spain, the UK, Japan, and China, which is indicative of the growing need for effective gastric cancer drugs, and the potential market open to IMAB362. A randomized, open-label Phase II trial named FAST (NCT01630083) demonstrated that IMAB362, in combination with EOX (epirubicin, oxaliplatin, and capecitabine) chemotherapy, significantly improved patients' progression-free survival and overall survival of previously untreated, claudin18.2-positive advanced gastric cancer patients compared with EOX alone. Progression free survival was 7.9 months with IMAB362, versus 4.8 months with EOX alone, while overall survival was 13.2 months versus 8.4 months. Indeed, IMAB362 is the first drug to have shown a survival benefit for gastric cancer patients in the first-line setting since the approval of Roche's Herceptin (trastuzumab) in 2010. Dr Fenix Leung, GlobalData's Senior Analyst covering Oncology and Hematology, explains: "The commercial potential of IMAB362 is huge, as the drug targets the first-line setting of advanced gastric cancer - the largest patient segment within the indication. "Although only patients with claudine18.2-positive gastric cancer would be eligible for the drug, GlobalData anticipates that the eligible pool of IMAB362 will be greater than that of Herceptin, meaning it could have peak sales in excess of $1 billion, compared with Herceptin's estimated peak sales of $402 million for the gastric cancer indication." Despite its potential success, certain risks will exist for IMAB362, as Ganymed is a small biopharma company that was spun off from the Universities of Mainz and Zurich. Dr Leung continues: "The company's size means it may not be able to finance a Phase III study for IMAB362 before receiving further investment, possibly allowing a number of competitors, including Eli Lilly's Cyramza and Merck and Co.'s Keytruda, to enter the market first. However, with its robust randomized Phase II data, IMAB362 thus far appears to be the most promising gastric cancer candidate." ]]> <![CDATA[Panacea Biotech launches type 2 diabetes drug 'Tenepan' ]]> https://biospectrumindia.com/news/95/8178/panacea-biotech-launches-type-2-diabetes-drug-tenepan-.html https://biospectrumindia.com/news/95/8178/panacea-biotech-launches-type-2-diabetes-drug-tenepan-.html Thu, 30 Jun 2016 11:50:54 +0530 Delhi-based biotech firm Panacea Biotech introduces indigenously developed high quality antidiabetic drug 'Tenepan', used for treatment of Type 2 Diabetes Mellitus. Tenapan aims to improve accessibility of diabetes treatment at an affordable cost as part of the company's commitment to the 'Make in India' campaign. Mr Rajesh Jain, Joint Managing Director, Panacea BioTech said. "Panacea BioTech has always endeavored to partner with medical practitioners in assisting to manage their patients better by introducing new innovative and good quality products." With the launch of Tenepan the company intends to reach out to the patients with the latest therapeutic treatment. ]]> <![CDATA[Grand Challenges Explorations India â€“ First call for proposals]]> https://biospectrumindia.com/news/95/6803/grand-challenges-explorations-india-first-call-for-proposals.html https://biospectrumindia.com/news/95/6803/grand-challenges-explorations-india-first-call-for-proposals.html Wed, 29 Jun 2016 17:23:22 +0530 The Biotechnology Industry Research Assistance Council (BIRAC), the Department of Biotechnology (DBT), Government of India in collaboration with the Bill & Melinda Gates Foundation and IKP Knowledge Park (IKP), a science park and start-up incubator announced the first call for proposals under the Grand Challenges Explorations India (GCE-India) programme. "The GCE-India programme aims to address challenges that are faced by the Indian healthcare system by encouraging innovative solutions to tackle the same. We are looking for ideas that have the potential to change how people look access healthcare in India. GCE-India looks to foster entrepreneurship in India. Our goal is the search for drug delivery systems, diagnostics, and technology enabled service models and medical devices that can potentially be made accessible to all," said Prof K VijayRaghavan, Secretary, DBT. The programme is seeking ideas in the following areas: contraceptive discovery platforms; new therapies for childhood cryptosporidium infection; preservation of stool samples for room-temperature transport and remote-analysis; global burden of antimicrobial resistance; point-of-care nucleic acid diagnostics below $2 per test; and self-testing for cervical cancer and malaria diagnostics. The awardee will be eligible for an award of INR 50 Lakh for 18 months, and a prize of INR 10 Lakh for successful completion of milestones. Successful projects will also have the opportunity to apply for follow-on funds from BIRAC through the Biotechnology Industry Partnership Programme (BIPP), Small Business Innovation Research Initiative (SBIRI) and/or the GCE Phase II program of the DBT, BIRAC and Bill & Melinda Gates Foundation. '"GCE-India is looking to empower potentially life-changing ideas and enable scale-up. Our network of highly qualified individuals will work with innovators to help refine strategy and provide technical consulting. Through this programme, we aim to identify nurture and empower revolutionary ideas that address global health challenges" said Dr Deepanwita Chattopadhyay, Chairman & CEO at IKP Knowledge Park. Apart from the funding, BIRAC and IKP Knowledge Park will closely work with the chosen candidates; provide them technical and business strategy advice, as also access to synergistic networks within the nation and outside; factors that would be critical to making an innovation a medical and commercial success. "GCE-India is the platform which will enable idea generation and help translate research into action. If India is to stand shoulder to shoulder with the larger economies, it is important that it becomes self-sufficient. Therefore, we expect that healthcare innovation from within the nation will be able to address the needs of the country better; GCE-India is a search to identify healthcare innovations in India that will enable standardized healthcare for all irrespective of where they seek it," said Dr Steven Buchsbaum, Deputy Director, Discovery & Translational Sciences, Bill & Melinda Gates Foundation. This Call for Proposals is open to everyone, from any discipline from India. The applicants may be researchers and faculty in colleges/ universities/government laboratories/ institutions to startups and SMEs as well as non-profit organizations. The program is accepting proposals until 11:59 PM, June 30, 2016 (IST). For information on eligibility, application process and selection criteria, please visit www.gce-india.org. ]]> <![CDATA[Leukemia has largest pipeline, most first-in-class innovation in hematological cancers space]]> https://biospectrumindia.com/features/95/6807/leukemia-has-largest-pipeline-most-first-in-class-innovation-in-hematological-cancers-space.html https://biospectrumindia.com/features/95/6807/leukemia-has-largest-pipeline-most-first-in-class-innovation-in-hematological-cancers-space.html Wed, 29 Jun 2016 17:22:19 +0530 Of the three major indications within hematological cancer, namely leukemia, lymphoma and myeloma, leukemia has the largest pipeline, with 798 products in active development, while lymphoma has 552 and myeloma has 396, according to business intelligence provider GBI Research. The company's latest report states that there are currently 1,234 pipeline products in active development in the hematological cancer therapy area, and for each of the three key indications, the composition by stage of development is relatively similar, although leukemia and myeloma have more products in clinical development. Mr Yasser Mushtaq, Senior Analyst for GBI Research, explains: "Leukemia has the most products in the hematological cancers pipeline, with 349 in clinical development and 446 in early-stage development, while three products had an undisclosed stage of development. In terms of individual stages, however, Preclinical is the largest across leukemia and lymphoma, while Phase II is the largest in myeloma. It is notable that Phase II also contains many products for leukemia and lymphoma, which is a promising trend for product development. "The leukemia indication contains the most first-in-class products, with 195, while the lymphoma and myeloma pipelines contain 186 and 82 first-in-class products, respectively." GBI Research's report also states that considerable unmet needs remain in hematological cancer, with acute myeloid leukemia (AML) particularly ill-served, as there is a need for more efficacious targeted therapies across all patient subtypes. The treatment of AML is still limited to conventional DNA-targeted chemotherapy regimens, which achieve long-term survival rates of 25-50% in patients below the age of 60, and only 5-15% in older patients, indicating a clear need for more efficacious treatments. Mr Mushtaq continues: "Across other forms of hematological cancer, while some targeted therapies are already present in the market, reducing the rates of relapse and improving survival rates among patients who do relapse are particular areas of need. "For example, across follicular lymphoma (FL), mantle cell lymphoma (MCL) and diffuse large B-cell lymphoma (DLCL), first-line treatment in patients is typically cytarabine-cased chemotherapy in combination with rituximab. Despite largely positive response rates, almost all patients ultimately relapse, with progression-free survival values of one to two years in MCL and above three years in FL and DLCL, presenting a notable need across the non-Hodgkin's lymphoma pipeline for more effective maintenance therapies to prevent disease relapse." ]]> <![CDATA[Hetreo launches biosimilar for colorectal cancer]]> https://biospectrumindia.com/news/95/5334/hetreo-launches-biosimilar-for-colorectal-cancer.html https://biospectrumindia.com/news/95/5334/hetreo-launches-biosimilar-for-colorectal-cancer.html Wed, 29 Jun 2016 14:36:01 +0530 Hetero recently announced the launch of biosimilar of 'Bevacizumab', used in treating metastatic colorectal cancer (mCRC), under the brand name 'CizumabTM'. Hyderabad-based Hetero is one of the world's largest producer of anti-retroviral drugs for the treatment of HIV/AIDS. Approved by the Drug Controller General of India (DCGI), the drug is used as a first-line treatment for mCRC, Hetero said in a statement. Commenting on the launch, Mr BPS Reddy, CMD, Hetero, said, ""It has been an exciting journey for us in biologics. Hetero's Bevacizumab is the third product in our biologics portfolio, after Darbepoetin alfa and Rituximab. We believe CizumabTM will be a cost-effective treatment option to patients." The drug will be marketed and distributed by Hetero Healthcare Limited, a group company of Hetero. The product will be made available to patients in a single dose vial with two strengths, 100 mg and 400 mg. The product will be manufactured in Hetero's dedicated state-of-the-art Biologics facility based in Hyderabad, India. The estimated annual incidence of colorectal cancer (CRC) worldwide is 1.3 million, making it the third most common cancer in males and the second most common cancer in females. There is asteady rise in number of cases observed in India, says a study. An analysis of the "Cancer Incidence in Five Continents" database shows an increase in CRC incidence in resource-constrained countries, including India, with a significantly higher proportion of early-onset cancers. ]]> <![CDATA[Pfizer spends $350M on Asian biotech hub]]> https://biospectrumindia.com/news/95/8424/pfizer-spends-350m-on-asian-biotech-hub.html https://biospectrumindia.com/news/95/8424/pfizer-spends-350m-on-asian-biotech-hub.html Wed, 29 Jun 2016 11:22:24 +0530 Pfizer has announced that it will invest approximately $$350 million in the development of a state-of-the-art Global Biotechnology Center at a ground-breaking ceremony in the Hangzhou Economic Development Area (HEDA) in China. This innovative facility will be Pfizer's third biotechnology center globally and the first in Asia. It will ensure the local production of high-quality, affordable biosimilar medicines that will benefit patients both in China and throughout the world. The establishment of the Pfizer Global Biotechnology Center also represents further investment in R&D and clinical research across China, which will further contribute to China's growing biopharmaceutical industry and economy. This Global Biotechnology Center will include an advanced modular facility by GE Healthcare, based on flexible single-use bio-manufacturing technology that meets strict international standards for quality, safety and efficiency, as well as accelerated speed of construction and superior environmental standards. This Center is expected to be completed in 2018. Pfizer will work closely with Chinese regulators to bring the biosimilar products produced at the Pfizer Global Biotechnology Center in Hangzhou to market as soon as possible. "We believe that the Pfizer Global Biotechnology Center in Hangzhou will help support China's aim to increase the complexity and value of its manufacturing sector by 2025, and contribute to building a truly innovative and vibrant biopharmaceutical industry," said Mr John Young, Group President, Pfizer Essential Health. "We are encouraged by a series of important reforms introduced by Chinese government that will further stimulate the industry to meet emerging health challenges, such as the rising incidence of non-communicable diseases and an aging population; as well as attract both domestic and foreign investment in healthcare and R&D." The Pfizer Global Biotechnology Center aims to support China's healthcare reforms, assist the Chinese government in its continuing efforts to update the local industry in this sector, and provide world-class biological medicines for patients in China and the world. The facility will house Pfizer China's Biosimilars and Biologics Quality, Technical Service, Logistics and Engineering divisions, in addition to commercial manufacturing, and will also serve as a process development and clinical supply site. This center will create more than 150 job opportunities and establish local biotechnology expertise that will help strengthen and promote innovation as well as modernize China's biopharmaceutical industry. "We plan on building on Pfizer's 30-year history in China by applying our Global expertise in manufacturing excellence and world-class capabilities to bring high-quality biosimilars to market," said Mr Tony Maddaluna, President of Pfizer Global Supply. "The local production of high-quality, affordable biosimilar medicines will have the potential to significantly improve the lives of patients not only in China but across the world." The new center will feature GE's single-use technology in a KUBioTM modular facility, which increases speed-to-market and manufacturing flexibility at costs of between 25 and 50 percent of equivalent traditional facilities in a build time that can be just 18 months as opposed to the usual three years. Carbon dioxide emissions, water and energy usage can also be reduced by 75 percent. "As governments and companies the world over strive to give patients access to a new class of life-changing biological medicines, GE's KUBio modular factories allow biopharmaceutical companies to get their products to market quickly so they can respond rapidly to local healthcare needs. KUBio's modular construction and single-use technologies, coupled with GE's deep expertise in bioprocessing design, enable speed and increased productivity at global GMP standards wherever they are needed," said Mr Kieran Murphy, CEO & President, GE Healthcare Life Sciences. ]]> <![CDATA[Sanofi, Boehringer swap animal, consumer health businesses]]> https://biospectrumindia.com/news/95/8332/sanofi-boehringer-swap-animal-consumer-health-businesses.html https://biospectrumindia.com/news/95/8332/sanofi-boehringer-swap-animal-consumer-health-businesses.html Tue, 28 Jun 2016 11:18:42 +0530 Sanofi and Boehringer Ingelheim announced the signing of contracts to secure the strategic transaction initiated in December 2015 which consists of an exchange of Sanofi's animal health business ("Merial") and Boehringer Ingelheim's consumer healthcare (CHC) business. This step marks a major milestone before closing of the transaction which is expected by year-end 2016 and remains subject to approval by all regulatory authorities in different territories. The integration of Boehringer Ingelheim's Consumer Healthcare (CHC) business into Sanofi and Merial into Boehringer Ingelheim would start after closing. Upon closing this transaction will be a significant business swap in the pharmaceutical sector and an important event in the history of both companies Prof Dr Andreas Barner, Chairman of the Board of Boehringer Ingelheim, said: "This is a win for Boehringer Ingelheim and Sanofi alike. Moreover, it is one of the most significant steps in our corporate history. It demonstrates the consistent orientation of our business towards innovation-driven sectors. As a research based pharmaceutical company, we will substantially enhance our position in the future market for Animal Health and will prospectively be one of the largest global players in this segment. The similarity in culture and approaches of BI and Sanofi will ensure that the businesses acquired by the other partner will develop well in the future." Dr Olivier Brandicourt, chief executive officer, Sanofi, said: "In signing these contracts, we are meeting one of the key strategic goals of our roadmap 2020, namely to become a leader in consumer healthcare and a leading diversified global human healthcare company. This business swap will bring a complementary portfolio to our consumer healthcare activity with highly recognized brands, allowing for mid and long term value creation, and enhancement of our market penetration in some major countries." The strategic swap lays the foundation for both companies to reach size and scale in two highly attractive pharmaceutical activities. Upon successful completion, Boehringer Ingelheim's CHC business - with an enterprise value of â‚¬6.7 bn - would be transferred to Sanofi and Sanofi's Merial - with an enterprise value of â‚¬11.4 bn - would be transferred to Boehringer Ingelheim. The transaction includes a cash payment to Sanofi of â‚¬4.7 bn to reflect the difference in value of the two businesses. Taking into account the expected contribution from the acquired CHC business, progressive implementation of synergies and the use of part of the net proceeds to buy shares back, Sanofi expects the overall transaction to be business EPS neutral in 2017 and accretive afterwards. Combining Merial and Boehringer Ingelheim's complementary portfolios and technology platforms in anti-parasitics, vaccines and pharmaceutical specialties would put the combined company into a more competitive position in the key growth segments of the industry and bring more value and innovation to customers globally. The Boehringer Ingelheim Animal Health business would more than double its sales to approx. â‚¬3.8 bn based upon 2015 global sales. With this transaction, Sanofi would integrate Boehringer Ingelheim's CHC business in all countries except China. Joint CHC sales would amount to approx. â‚¬4.9 bn2 based upon 2015 global sales. Thanks to the addition of a highly complementary product and brand portfolio, Sanofi would enhance its position in several of its strategic categories - Pain Care, Allergy Solutions, Cough & Cold Care, Feminine Care, Digestive Health and Vitamins, Minerals and Supplements. The signing was preceded by six months of constructive and successful negotiations which went according to plan. Both companies have reviewed and discussed the details of the transaction. This included the exact scope of the business swap as well as ensuring compliance with regulatory requirements. In the past months, Boehringer Ingelheim and Sanofi also closely consulted with the relevant social bodies in France and Germany as well as with the appropriate regulatory authorities to lay the groundwork for the realization of the business swap. In accordance with their commitment at the beginning of the negotiations, the companies agreed that Lyon (France) and Toulouse (France) would be key operational centers of Boehringer Ingelheim's Animal Health business, including business operations, R&D and manufacturing facilities in Lyon and the production site in Toulouse. ]]> <![CDATA[Idiopathic Pulmonary Fibrosis market to grow to $3.2 bn by 2025]]> https://biospectrumindia.com/features/95/7818/idiopathic-pulmonary-fibrosis-market-to-grow-to-3-2-bn-by-2025.html https://biospectrumindia.com/features/95/7818/idiopathic-pulmonary-fibrosis-market-to-grow-to-3-2-bn-by-2025.html Mon, 27 Jun 2016 10:58:27 +0530 The company's latest report states that such growth, which will occur across the seven major markets (7MM) of the US, France, Germany, Italy, Spain, the UK, and Japan, will primarily be driven by the increased use of expensive therapies, the anticipated launches of two novel therapies, FibroGen's FG-3019 and Promedior's PRM-151, and a rise in diagnosed prevalent cases of the disease. Mr Matthew Thaxter, GlobalData's Analyst covering Immunology, explains: "Currently, the IPF market is largely under-penetrated, with only two approved treatments across the 7MM. However, pharmaceutical companies are increasingly starting to view the IPF drug market as one with commercial potential. "IPF has an attractive patient population size, with almost 108,000 diagnosed prevalent cases in the 7MM, and the opportunity to attain orphan drug status, potentially allowing a faster and more cost-efficient research and development program." As the IPF market has been largely neglected to date, the level of unmet needs within the indication remains high, both environmentally - in terms of treatment cost, patient awareness, and physician education - and clinically. Indeed, the foremost unmet is the lack of an efficacious therapy which is capable of halting the progression of the disease. Mr Thaxter explains: "The two currently approved products - Roche's Esbriet and Boehringer Ingelheim's Ofev - are not capable of meeting this particular unmet need, as they serve merely to slow the decline in patients' lung function. Promising Phase II drugs are set to be developed and approved over the forecast period to 2025, and the IPF market will evolve, due to the improvements offered by these newer drugs. "There will be continued effort on behalf of both pharmaceutical companies and other industry stakeholders to increase the awareness of IPF among patients and physicians alike, thereby improving diagnosis and treatment rates. Excitingly, following the approvals of FibroGen's FG-3019 and Promedior's PRM-151 into the IPF therapeutic market, anticipated in 2021 and 2023, respectively, the unmet need for a therapy that can reverse or stabilize fibrosis will have been met." ]]> <![CDATA[Cancer Genetics Inc. partners with Sayre Therapeutics]]> https://biospectrumindia.com/news/95/8140/cancer-genetics-inc-partners-with-sayre-therapeutics.html https://biospectrumindia.com/news/95/8140/cancer-genetics-inc-partners-with-sayre-therapeutics.html Fri, 24 Jun 2016 11:25:22 +0530 Cancer Genetics, Inc. announces an exclusive distribution agreement that provides Sayre Therapeutics sales and marketing rights of Cancer Genetics' Tissue of Origin(TOO) test in India and South Asia. TOO data generated by the use of the test in India will contribute to the expansion of CGI's knowledge base to further validate the clinical utility of the test on a global basis. "We view this partnership with Sayre as an important milestone in making precision medicine increasingly available outside the US, especially in high-growth, high-demand markets like India," said Mr Panna Sharma, CEO and President of Cancer Genetics. "We plan to continue broadening the access to our unique, proprietary portfolio of genomic and biomarker driven tests, which help in the management of cancer care, and Sayre has demonstrated reach and influence in the oncology sector throughout India." According to Dr Palanki Satya Dattatreya, Senior Consultant and Medical Oncologist at Omega Hospitals, in Hyderabad, India, "Cancer of Unknown Primary (CUP) is not an uncommon condition in India. CUP continues to be an enigma to the physicians and an aggressive disease with unfavorable prognosis to the patients. Generally, CUP patients are subjected to a battery of repeated tests and go through agonizing uncertainty about their disease condition. The Tissue Of Origin (TOO) test, which is based on the principle of gene expression profiling, can be very useful in such cases. TOO test with its high specificity and sensitivity takes away the element of ambiguity, and enables the patient to get a more specific guideline-based therapy which translates into potentially better survival rates." CGI's TOO is a microarray-based gene expression test that aids in identifying challenging tumors, including metastatic, poorly differentiated, and undifferentiated cancers. It is able to report the tissue of origin of 15 of the most common tumor types (thyroid, breast, non-small cell lung, pancreatic, gastric, colorectal, liver, bladder, kidney, non-Hodgkin's lymphoma, melanoma, ovarian, sarcoma, testicular germ cell, and prostate tumors), representing 58 cancer morphologies and covering 90% of all solid tumors. TOO leads to a change in treatment 65% of the time. Sayre has begun active marketing efforts in major metro markets of India and South Asia and has held seminars and workshops with key opinion leaders and clinicians. "It is heartening to note that many physicians are very positive about the test and feel that this is the way forward in making guided decisions or modifications of the treatment plan of patients with Cancer of Unknown Primary (CUP)", said Mr Ravindranath Kunjithai, Head Medical and Regulatory Affairs at Sayre Therapeutics. ]]> <![CDATA[Glenmark bags FDA approval for new generic]]> https://biospectrumindia.com/news/95/3658/glenmark-bags-fda-approval-for-new-generic.html https://biospectrumindia.com/news/95/3658/glenmark-bags-fda-approval-for-new-generic.html Fri, 24 Jun 2016 11:25:03 +0530 Glenmark Pharmaceuticals Inc., USA (Glenmark) has been granted final approval by the United States Food & Drug Administration (US FDA) for Nystatin and Triamcinolone Acetonide Ointment USP, 100,000 units/1 mg per gram, the generic version of Nystatin and Triamcinolone Acetonide Ointment USP, 100,000 units/1 mg per gram of Taro. Glenmark Pharmaceuticals Inc., USA (Glenmark) has also been granted tentative approval by the United States Food & Drug Administration (US FDA) for Olmesartan Medoxomil Tablets, 5 mg, 20 mg and 40 mg, the generic version of Benicar Tablets of Daiichi Sankyo, Inc ]]> <![CDATA[Rheumatoid Arthritis testing market to approach $400 mn by 2022]]> https://biospectrumindia.com/features/95/8343/rheumatoid-arthritis-testing-market-to-approach-400-mn-by-2022.html https://biospectrumindia.com/features/95/8343/rheumatoid-arthritis-testing-market-to-approach-400-mn-by-2022.html Thu, 23 Jun 2016 14:40:43 +0530 The rheumatoid arthritis testing market is forecast to rise from $338.5 million in 2015 to $399.5 million by 2022, representing a modest compound annual growth rate (CAGR) of 2.4%, according to research and consulting firm GlobalData. The company's latest report states that the growth, which covers 15 major markets, will mainly be driven by the increasing prevalence of autoimmune diseases globally, emerging biomarkers and advancement in technology for early diagnosis of rheumatoid arthritis, increasing adoption of anti-cyclic citrullinated peptide (anti-CCP) antibody tests, and rising demand for lab automation. Ms Wenlu Hu, GlobalData's Analyst covering Medical Devices, explains: "Anti-CCP tests are particularly effective, with trials demonstrating that the method has similar sensitivity to rheumatoid factor testing, the current diagnostic gold standard, but is much more specific. In this way, the commercialization of anti-CCP tests will provide key growth opportunities for rheumatoid arthritis test kit manufacturers. "Currently, it is the higher costs of these test kits and limited sensitivity when performed as individual tests are the major factors restraining their wide adoption. However, revenue contribution of the anti-CCP test segment has been estimated to be the fastest growing, and it is expected to be one of the most lucrative segments, growing at a steady single-digit CAGR between 2015 and 2022." Generally, healthcare cost-cutting and reduced reimbursement in major markets will be one of the primary barriers affecting the market and preventing it from growing at a more impressive rate. Growth in Europe will be particularly sluggish, with Germany, for example, attaining a low single-digit CAGR over the forecast period. Ms Hu explains: "Manufacturers should look to emerging markets such as China, India, and Brazil if they want relatively fast growth. Brazil's market is set to grow at the fastest rate compared to the rest of the 15 major countries, as its economy flourishes on the back of a growing middle class and rising investment in the country's physical infrastructure." GlobalData's report also states that the rheumatoid arthritis market in 2015 was dominated by Roche, followed by Abbott, Siemens, and Beckman Coulter. ]]> <![CDATA[Global cancer treatment market grew to $107 bn in 2015]]> https://biospectrumindia.com/features/95/8377/global-cancer-treatment-market-grew-to-107-bn-in-2015.html https://biospectrumindia.com/features/95/8377/global-cancer-treatment-market-grew-to-107-bn-in-2015.html Thu, 23 Jun 2016 12:56:33 +0530 More than 20 tumor types are being treated with one or more of the 70 new cancer treatments that have been launched in the past five years, with the sustained surge in innovative therapies driving the global oncology market to $107 billion in 2015. However, many of these drugs are not yet available to patients in most countries, and even when registered they may not be reimbursed under public insurance programs, according to a new study released by the IMS Institute for Healthcare Informatics. The study-Global Oncology Trend Report: A Review of 2015 and Outlook to 2020-finds that growth in global spending on oncology therapeutics and supportive care drugs increased 11.5 percent on a constant-dollar basis last year. Growth is measured using ex-manufacturer prices and does not reflect off-invoice discounts, rebates or patient access programs. A large and diverse set of more than 500 companies is actively pursuing oncology drug development around the world. Collectively, they are advancing nearly 600 new molecules through late-stage clinical development, most frequently for non-small cell lung cancer and breast, prostate, ovarian and colorectal cancers. Annual global growth in the oncology drug market is expected to be 7.5 - 10.5 percent through 2020, reaching $150 billion. Wider utilization of new products-especially immunotherapies-will drive much of the growth, offset by reduced use of some existing treatments with inferior clinical outcomes. Payers also are expected to tighten their negotiation stance with manufacturers and adopt new payment models in an effort to drive greater value from their expenditures on these drugs. "The new science redefining cancer as a large number of narrowly defined diseases and yielding therapeutic options for an expanding number of patients is rapidly transforming the oncology treatment landscape," said Mr Murray Aitken, IMS Health senior vice president and executive director of the IMS Institute for Healthcare Informatics. "Most health systems are struggling to adapt and embrace this evolution-including the regulatory systems, skilled professionals, diagnostic and treatment infrastructures, and financing mechanisms that are required to serve the needs of cancer patients around the world. These challenges demand urgent attention in light of the strong near-term pipeline of clinically distinctive therapies, and new programs such as the US government's 'cancer moon shot' that are galvanizing research efforts to change the trajectory of cancer." The report's other key findings include the following: â€¢ Sustained level of innovation expected through 2020. The pipeline of oncology drugs in clinical development has expanded by more than 60 percent during the past decade, with almost 90 percent of the focus on targeted agents. The median time from patent filing to approval for oncology drugs in 2015 was 9.5 years, down from 10.3 years in 2013. A series of initiatives, including the FDA Breakthrough Therapy designation introduced in 2012, may be contributing to the reduction. In the past three years, three molecules were approved within four years of patent registration. â€¢ The availability of new cancer treatments varies widely around the world. Of the 49 oncology New Active Substances analyzed that were initially launched between 2010 and 2014, fewer than half were available to patients by the end of 2015 in all but six countries: the US, Germany, UK, Italy, France and Canada. This reflects manufacturers' efforts to file for registration in each country, as well as the regulatory process and timing. Targeted immunotherapies are available in most developed countries, but none of the emerging markets outside of the European Union has yet registered these treatments. Even when available through the regulatory review process, not all cancer drugs are accessible to patients due to lack of reimbursement under public insurance programs. Of the drugs approved in 2014 and 2015 by a set of developed countries analyzed, only the US, France and Scotland have more than half included on reimbursement lists at the end of 2015. In some cases, reimbursement may be provided in the future for specific indications, depending on health technology assessments or other processes used by the country. â€¢ The growth in costs of oncology therapeutics and supportive care has accelerated since 2011. The annual growth rate in cancer drug costs has risen from 3.8 percent in 2011 to 11.5 percent in 2015, at constant exchange rates. Growth in the US market increased from 2.0 percent to 13.9 percent in the same period. The US now accounts for about 45 percent of the global total market for therapeutics, up from 39 percent in 2011, due in part to the strengthening of the US dollar and more rapid adoption of newer therapies. In the US, cancer drugs now make up 11.5 percent of total drug costs, up from 10.5 percent in 2011. Pricing concessions by manufacturers-including mandatory and negotiated rebates, discounts and patient cost offsets-are reducing manufacturer-realized net sales across many markets. Net price growth in the US on existing branded oncology drugs have averaged an estimated 4.8 percent in 2015, compared with 6.4 percent invoice price growth. In Europe, a wide range of discounts and other mechanisms also exist, resulting in lower realized prices by manufacturers. â€¢ The distribution of cancer drugs is shifting due to reimbursement changes and expanded use of targeted therapies. The mix of oncology drugs distributed through hospitals/clinics and retail channels varies widely across countries and reflects differences in healthcare practice, reimbursement and mix of formulations. In European markets including Italy, Spain and the UK, costs have shifted to hospital channels during the past five years, while in Canada, France and the US costs have increased more rapidly in retail channels. In the US, cancer drugs dispensed through retail channels now account for more than one-third of total costs, up from 25 percent ten years ago and typically covered by pharmacy benefits. This reflects a shift in the mix of new therapies toward oral medicines, eliminating the need for injection or infusion in a physician's office or outpatient facility. Nearly 40 percent of the total costs of targeted therapies in the US are now for oral formulations, up from 26 percent in 2010. â€¢ Key trends within the US oncology market include a shift toward integrated delivery systems, rising treatment costs and higher patient out-of-pocket expenses. Only 17 percent of US oncologists are in independent practices, unaffiliated with some type of integrated delivery network or corporate parent, down from 28 percent in 2010. State-level variation is wide, with 14 states having fewer than 10 percent of oncologists in independent practices, and six states having more than 30 percent. Average total treatment costs for patients in commercial insurance plans with a cancer diagnosis who are receiving active treatment reached $58,000 in 2014, up 19 percent from 2013. Patients with commercial insurance who were treated in 2014 with cancer drugs received by injection or infusion were responsible for more than $7,000 of costs on average, compared to $3,000 for those patients receiving only oral medicines. Some type of coupon or patient cost offset was used for more than a quarter of cancer drug retail prescriptions filled by patients with commercial insurance in 2015, up from 5 percent in 2011 and reflecting efforts by manufacturers to reduce patient out-of-pocket costs. The average cost offset has averaged about $750 per prescription over the past five years. ]]> <![CDATA[Biocon, Quark initiates study of QPI-1007 in rare eye disease ]]> https://biospectrumindia.com/news/95/8382/biocon-quark-initiates-study-of-qpi-1007-in-rare-eye-disease-.html https://biospectrumindia.com/news/95/8382/biocon-quark-initiates-study-of-qpi-1007-in-rare-eye-disease-.html Thu, 23 Jun 2016 12:55:47 +0530 Biocon and Quark Pharmaceuticals,a leader in the discovery and development of novel RNA interference (RNAi)-based therapeutics, announced the randomization of the first patient in India in the pivotal global Phase II/III study of QPI-1007, a novel siRNA (small interfering RNA) drug candidate for ocular neuroprotection. Biocon and its partner, Quark Pharmaceuticals, have received approval from the Drug Controller General of India (DCGI) to proceed with the study, the first ever clinical trial of a siRNA therapy in India. The QRK207 study will determine the effect of QPI-1007 on visual function in subjects with acute non-arteritic ischemic optic neuropathy (NAION), which is a rare ocular disorder with an unmet need globally. This is part of a global Phase II/III study run by Quark in collaboration with "Neuro-Ophthalmology Research Disease Investigator Consortium" (NORDIC) and is already enrolling in the US and a number of other countries. Biocon Chairperson & Managing Director Kiran Mazumdar-Shaw said, "Biocon is committed to develop innovative therapies that address unmet medical needs and the initiation of the Phase II/III study investigating QPI-1007 in NAION in India is an important step towards this goal. India has a significant NAION patient population and we are pleased to be the first biopharma company in the country to provide an siRNA-based therapy that is likely to benefit thousands of patients who either have no access to treatment or cannot afford it." "siRNA therapeutics is a new class of breakthrough medicines, with the potential to revolutionize drug development and offer therapeutic precision and widespread applicability and we are delighted to initiate QRK207 in India in this multi-national study to seek a treatment for NAION, a debilitating condition," stated Dr Daniel Zurr, chairman and CEO of Quark. "QPI-1007 represents a novel therapeutic strategy for treating NAION and future plans are to develop it for additional optic neuropathies, including glaucoma, which, similar to NAION, are characterized by the death of retinal ganglion cells." "It takes strong partnerships to translate novel science into commercial therapies to help people and we are extremely pleased to have partnered with Biocon, an innovative company best positioned to lead the siRNA based drug class development in India," added Dr Zurr. Biocon and Quark Pharma had entered into a licensing and collaboration agreement in 2013 to co-develop, manufacture and commercialize QPI-1007 in India and other key markets. ]]> <![CDATA[FDA approves Lupin's new generic]]> https://biospectrumindia.com/news/95/8385/fda-approves-lupins-new-generic.html https://biospectrumindia.com/news/95/8385/fda-approves-lupins-new-generic.html Thu, 23 Jun 2016 12:55:20 +0530 Pharma Major Lupin announced that its US subsidiary, Gavis Pharmaceuticals LLC., (collectively Lupin) has received final approvals for its Voriconazole Tablets, 50 mg & 200 mg and Voriconazole Oral Suspension, 40 mg/mL from the United States Food and Drug Administration (FDA) to market a generic equivalent of PF Prism C.V's Vfend Tablets, 50 mg & 200 mg and Vfend Oral Suspension, 40 mg/mL. Lupin shall commence promoting the products in the US shortly. Voriconazole Tablets, 50 mg & 200 mg and Voriconazole Oral Suspension, 40 mg/mL are the AB rated generic equivalent of PF Prism C.V's Vfend Tablets, 50 mg & 200 mg and Vfend Oral Suspension, 40 mg/mL. It is indicated for use in patients 12 years of age and older in the treatment of the following fungal infections: â€¢Invasive Aspergillosisâ€¢Candidemia in Non-neutropenic patients and the following Candida infections: Disseminated infections in skin and infections in abdomen, kidney, bladder wall and woundsâ€¢Esophageal Candidiasisâ€¢Serious fungal infections caused by Scedosporium apiospermum (Asexual form of Pseudallescheria boydii) and Fusarium spp. including Fusarium solani in patients intolerant of or refractory to other therapy Vfend Tablets, 50mg & 200mg had US sales of $92.8 million (IMS MAT March 2016) while Vfend Oral Suspension, 40 mg/mL had US sales of USD 15.9 million (IMS MAT March 2016). ]]> <![CDATA[Roche's Tecentriq may dominate bladder cancer market]]> https://biospectrumindia.com/features/95/8384/roches-tecentriq-may-dominate-bladder-cancer-market.html https://biospectrumindia.com/features/95/8384/roches-tecentriq-may-dominate-bladder-cancer-market.html Wed, 22 Jun 2016 16:33:38 +0530 As explored in an abstract presented at the 2016 American Society of Clinical Oncology (ASCO) conference, the launch of Roche's recently approved PD-1 immune checkpoint inhibitor Tecentriq (atezolizumab) will usher in a dramatic change in the treatment paradigm of metastatic bladder cancer, according to an analyst with research and consulting firm GlobalData. The company's most recent bladder cancer report states that the disease's setting has been largely stagnant for almost 20 years, which largely explains why Tecentriq has generated a considerable level of interest. In fact, on the heels of its approval as a second-line therapy following failure on platinum-based chemotherapy, there is already buzz about its potential expansion into the first-line setting. GlobalData believes that the trial results presented at ASCO 2016 showed Tecentriq to be worthy of its praise. Of the 119 patients who were treated with Tecentriq once every three weeks in the drug's Phase II, single-arm IMvigor 210 trial, overall response rate was reported to be 24% in all patients, with 7% being complete responses at a median follow-up of 14.4 months. Median overall survival was reported to be 14.8 months. Dr Cai Xuan, GlobalData's Analyst covering Oncology and Hematology, explains: "The durable complete responses seen with Tecentriq treatment are extremely significant in advanced stage bladder cancer, as the disease is currently almost uniformly fatal. Though results from different trials should be compared with caution, it appears that despite a slightly lower overall response rate for Tecentriq than carboplatin-gemcitabine - the most commonly used frontline therapy - the patients who do respond to Tecentriq are gaining significant overall survival benefit compared to existing treatment options. "Given the advanced age of most bladder cancer patients at diagnosis, it is estimated that up to 40% cannot receive cisplatin-based therapy due to renal impairment or other co-morbidities. According to GlobalData's forecast, Tecentriq is set to reach sales of $270 million by 2017. If Roche can win a label expansion for the drug in the first-line setting, it can further solidify its expected dominance in the bladder cancer market as this would mean a larger target patient pool and potentially longer duration of therapy as compared with its current approval in the second line. "This will depend on results from a larger randomized trial with the appropriate carboplatin-based chemotherapy comparator arm, and continued follow-up data from the patients who have confirmed complete responses in the current IMvigor 210 study." ]]> <![CDATA[Pharmaceutical companies increasingly looking to innovate high-risk, first-in-class products ]]> https://biospectrumindia.com/features/95/8383/pharmaceutical-companies-increasingly-looking-to-innovate-high-risk-first-in-class-products-.html https://biospectrumindia.com/features/95/8383/pharmaceutical-companies-increasingly-looking-to-innovate-high-risk-first-in-class-products-.html Wed, 22 Jun 2016 16:33:02 +0530 With the cost of bringing a single novel drug to market estimated to be $2.6 billion in 2015, pharmaceutical companies are increasingly looking towards developing first-in-class treatments to maximize revenue and stay ahead of competition, according to business intelligence provider GBI Research. The company's latest report states that the growth in drug research and development (R&D) costs appears to stem from an increased clinical failure rate and emphasis on proving superiority over comparator drugs in technology assessments, as well as an increasing level of sophistication from payers when assessing the cost-effectiveness of drugs. Mr Dominic Trewartha, Managing Analyst for GBI Research, explains: "Due to the inherently limited life cycle of a patented drug and growing R&D costs as a percentage of net sales, the pharmaceutical industry has the highest R&D expenditure of all industries. As such, imperatives for pharmaceutical companies include reducing product development costs, maximizing the annual product revenue, and optimizing the life cycle of a drug, primarily by minimizing the impact of the entry of generics. Together, these factors favor the inclusion of first-in-class pipeline products within a balanced pipeline portfolio." Higher-risk programs for innovative first-in-class products remain attractive and have led to some of the most clinically and commercially successful products over the past decade, and the 4,964 first-in-class products currently in development represent 37.9% of pharmaceutical pipeline products with a disclosed molecular target. Overall, 'me-too' drugs, which are structurally very similar to already-established drugs, have traditionally been highly commercially and clinically successful. These products continue to provide a well-established pathway for promising product developments due to a lower risk profile based on safer and more cost-effective incremental innovation. Dr Trewartha concludes, however: "Some of the most successful products of the previous ten years have been first-in-class therapies, including Avastin (bevacizumab), Rituxan (rituximab), Herceptin (trastuzumab) and Gleevec (imatinib). Additionally, when 2015 FDA approvals are analyzed, first-in-class products have far higher average projected sales than non-first-in-class products, indicating that this trend is set to continue in the future. "GBI Research believes that despite the high risks involved in developing first-in-class products, pharmaceutical companies stand to earn high rewards through innovative development strategies." ]]> <![CDATA[Zydus acquires two ANDAs from Teva, strengthens its US portfolio]]> https://biospectrumindia.com/news/95/8246/zydus-acquires-two-andas-from-teva-strengthens-its-us-portfolio.html https://biospectrumindia.com/news/95/8246/zydus-acquires-two-andas-from-teva-strengthens-its-us-portfolio.html Wed, 22 Jun 2016 12:55:18 +0530 Zydus has strengthened its US portfolio with the acquisition of two ANDAs from Teva that are being divested by Teva as a pre-condition to its acquisition of Allergan's generic business. The acquisition of these ANDAs is contingent on the closing of the Teva-Allergan Generics transaction and approval by the US Federal Trade Commission. The financial details of the transaction are undisclosed. The company said that these ANDAs have been acquired by its 100% subsidiary, Zydus Worldwide DMCC and the transaction will be financed through the group's internal accruals. The acquired portfolio comprises an ANDA which is already commercialized and one pipeline ANDA which is a transdermal patch. The estimated market size of the two ANDAs put together is nearly US$ 200 Mio. Speaking on the development, Mr Pankaj R Patel, chairman and managing director of the Zydus Group said that this is an important acquisition which will help Zydus to expand its existing portfolio in the US and strengthen its pipeline of complex generic products. Zydus has made significant investments in the transdermal manufacturing technology and had also acquired a transdermal manufacturing facility in the US, a few years ago. He said, "Zydus is upbeat about the growth potential in the US and will continue to pursue more inorganic opportunities in the US market." ]]> <![CDATA[Cipla inks pact with Russian firm Nacimbio for antiretroviral drugs ]]> https://biospectrumindia.com/news/95/8405/cipla-inks-pact-with-russian-firm-nacimbio-for-antiretroviral-drugs-.html https://biospectrumindia.com/news/95/8405/cipla-inks-pact-with-russian-firm-nacimbio-for-antiretroviral-drugs-.html Mon, 20 Jun 2016 11:04:27 +0530 National Immunobiological Company (State Corporation Rostech) together with Cipla Limited, a global pharmaceutical company, during SPIEF'16 signed Memorandum of Understanding on innovative antiviral medical products for HIV and Hepatitis C treatment and on technology transfer and active pharmaceutical ingredients (API) manufacturing. New drugs production will help to change therapeutic regimens and substantially increase availability of drugs for Russian patients. By 2019 total market share for anti-HIV drugs will increase to 60%. Nacimbio CEO Mr Nikolay Semenov and Mr Chandru Chawla, Head of Cipla New Ventures, signed the Memorandum of Understanding on technology transfer for manufacturing of anti-HIV drugs and drugs for Hepatitis C treatment. "Today patients undergoing anti-HIV treatment have to take a lot of drugs every day. Our preparations will meet the expectations of Russian patients and will solve this problem. In 2017 we will finalize construction and validation of the manufacturing plant together with Cipla Ltd., products will be commercially available in 2018. Total investment in the project will be over 2.8 billion roubles, stated Nacimbio CEO Mr Nikolay Semenov." "Currently there is no technology for full-cycle manufacturing of HIV treatment drugs in Russia," said Mr Subhanu Saxena, MD & Global CEO, Cipla Ltd. "We are glad that, as a responsible partner together with Nacimbio we will be able to improvedrug availability for patients and make our contribution to the fight against HIV."About ]]> <![CDATA[Pharmaceutical industry licensing deals soared to record $46.2 bn in 2015]]> https://biospectrumindia.com/features/95/8040/pharmaceutical-industry-licensing-deals-soared-to-record-46-2-bn-in-2015.html https://biospectrumindia.com/features/95/8040/pharmaceutical-industry-licensing-deals-soared-to-record-46-2-bn-in-2015.html Fri, 17 Jun 2016 17:37:07 +0530 Licensing deal values in the pharmaceutical industry rose by 37.1% year-to-year, from $33.7 billion in 2014 to $46.2 billion in 2015, driven primarily by Sanofi, which struck three licensing deals that totaled nearly $9 billion, according to research and consulting firm GlobalData. In the company's latest whitepaper, Mr Gianfranco Zeppetelli, GlobalData's Deals Analyst, explains: "Sanofi inked two key partnerships for metabolic indications, the first of which was a $4.3 billion partnership with South Korea's Hanmi Pharma. Sanofi gained exclusive worldwide license to develop and commercialize three pipeline products for the treatment of type 2 diabetes. "Sanofi also made a $1.7 billion agreement with Lexicon Pharma to manufacture and sell sotagliflozin (LX-4211), an investigational oral dual inhibitor of SGLT-1 and SGLT-2 currently in Phase III development." GlobalData's whitepaper states that there has been a surge in investment of deals in the Immuno-Oncology (I-O) space over the past five years, as immunotherapies have advanced significantly, becoming the pillar of cancer treatment. In the I-O space, Sanofi signed a $2.7 billion deal to co-develop Regeneron's REGN-2810, a programmed cell death protein 1 (PD-1) inhibitor currently in Phase I testing. Another important I-O partnership was Pfizer's $2.9 billion agreement with Merck KGaA to develop and commercialize avelumab (MSB-0010718C), an investigational anti-PD-L1 monoclonal antibody in Phase II development as a potential treatment for multiple metastatic and advanced solid tumors, including breast and prostate cancer. Under the terms of the agreement, Merck KGaA will receive an upfront payment of $850 million and is eligible to receive regulatory and commercial milestone payments of up to approximately $2 billion. Mr Zeppetelli continues: "Pharma companies are adapting to current market dynamics and positioning themselves for growth through portfolio transformation, targeted deal-making, cost-cutting measures, and sharpening their focus on high-performing therapeutic areas, and geographic markets." "We believe deal prices will continue to rise in 2016, as many big pharma companies look to increase their market share in specific therapeutic areas against their competitors." ]]> <![CDATA[Zika vaccine race overlooks need for global strategy to combat mosquito-borne diseases]]> https://biospectrumindia.com/features/95/8028/zika-vaccine-race-overlooks-need-for-global-strategy-to-combat-mosquito-borne-diseases.html https://biospectrumindia.com/features/95/8028/zika-vaccine-race-overlooks-need-for-global-strategy-to-combat-mosquito-borne-diseases.html Fri, 17 Jun 2016 17:35:50 +0530 The development of a protective vaccine against the Zika virus represents only one step in providing a long-term solution to the disease, and should be viewed in the context of tackling all mosquito-borne diseases, according to research and consulting firm GlobalData. The company's latest analysis covering the endemic states that the uncertainty around the Zika virus, which is transmitted by the Aedes aegypti species of mosquito, has brought Flaviviruses to the world's attention and should be used not only to develop a vaccine specifically protecting against the Zika virus, but to formulate a global strategy against mosquito-borne diseases. Dr Mirco Junker, GlobalData's Analyst covering Infectious Diseases, says: "The Zika virus is a member of the genus Flavivirus, a group of single-stranded RNA viruses that also includes dengue, West Nile, yellow fever, Japanese encephalitis, and chikungunya virus, all of which are transmitted by mosquitoes. "Approaches to combatting the vector instead of the virus include the prevention of vector reproduction through limiting the breeding ground, insecticides, direct genetic manipulation, or the usage of bacteria ultimately leading to the demise of the mosquitoes." In terms of potential vaccines, the vast majority of Zika vaccine products are currently in early preclinical trials, indicating that it will take many years until one of them receives market approval. However, for pharmaceutical companies, developing vaccines is a difficult and resource-intensive process. Dr Junker continues: "The majority of companies that have entered the race are smaller biotech companies with limited resources, while the large pharmaceutical companies, including GlaxoSmithKline, Johnson & Johnson, Merck, Pfizer, Sanofi, and Takeda, are currently only evaluating how their abilities and experiences can help in the fight against Zika. "Vaccines are based on biological agents that require stringent establishment of lot-to-lot consistency and stability, and from a scientific perspective, it is also not yet clear which vaccine strategy will ultimately lead to a protective vaccine. "These complicating factors highlight the need for more collaboration between the companies themselves, as well as support from governmental organizations in identifying the most promising vaccine candidates and bringing them to the market." ]]> <![CDATA[e-Pharmacy seek govt help for level playing field]]> https://biospectrumindia.com/news/95/8366/e-pharmacy-seek-govt-help-for-level-playing-field.html https://biospectrumindia.com/news/95/8366/e-pharmacy-seek-govt-help-for-level-playing-field.html Fri, 17 Jun 2016 17:34:55 +0530 In the wake of growing harassment faced by entrepreneurs in the field of e-Pharmacy, the Indian Internet Pharmacy Association has sought support from regulators and the government. Prashant Tandon, co-founder of 1mg.com, along with IIPC members has urged the government "to create a level playing field for the upcoming e-Pharmacy model to thrive". The e-Pharmacy business model has been in news for various reasons. Maharashtra FDA recently lodged a complaint against PharmEasy, one of India's leading e-Pharmacy platform, however, police investigated the matter and come to the conclusion that there is was no violation of FDA rules and regulations, vindicating PharmEasy's stand. Similarly, in Karnataka, the licences of Zigy and Medidart were cancelled, and thereafter revoked post investigations. For Zigy, the e-Pharmacy marketplace, the licence for a vendor partner in Bengaluru was cancelled. After several hearings with the Appellate Court, cancellation was revoked and operations found to be in good standing. The new age retail pharmacies want to partner with digital platforms to develop and grow business; and investors have shown interest. However, the unprecedented and high-handed activity by AIOCD and Maharashtra FDA brought up serious questions around re-strengthening of 'license raj', and negative environment for innovation, especially in Maharashtra. "Consumers are benefitting from increased transparency, access, affordability and convenience. The model also holds tremendous promise for the regulatory body to tackle issues of fake medicines since the supply chain is well documented and tracked and ensures better pharmaco vigilance," said IPA. The IPA members have requested the sub-committee created by the 48th Drug Consultative Committee to formulate guidelines on the use of technology & e-Pharmacies. They have also suggested best practices from around the world to help draw a model system of pharmacy retail in India, and are keen to work with the regulator to draw a blueprint to address all the issues that plague this sector. ]]> <![CDATA[Jardiance reduced the risk of progressive kidney disease in adults with type 2 diabetes ]]> https://biospectrumindia.com/news/95/3843/jardiance-reduced-the-risk-of-progressive-kidney-disease-in-adults-with-type-2-diabetes-.html https://biospectrumindia.com/news/95/3843/jardiance-reduced-the-risk-of-progressive-kidney-disease-in-adults-with-type-2-diabetes-.html Fri, 17 Jun 2016 13:19:18 +0530 New data showed Jardiance (empagliflozin) reduced the risk for new-onset or worsening kidney disease by 39 percent versus placebo when added to standard of care in people with type 2 diabetes with established cardiovascular disease. Boehringer Ingelheim and Eli Lilly and Company announced that the findings have been published in The New England Journal of Medicine and also presented at the American Diabetes Association (ADA) 76th Scientific Sessions in New Orleans. "These findings are clinically important, given that one in two people with type 2 diabetes worldwide will develop kidney disease, which can lead to kidney failure and eventually the need for dialysis." said Prof Christoph Wanner, Chief of the Division of Nephrology and Hypertension at the University Hospital of WÃ¼rzburg, Germany. "Since diabetes is the number one reason people require dialysis treatment, novel treatments that may have the potential to help address this crucial medical need are necessary." These findings were part of a pre-specified exploratory analysis plan of additional endpoints of the landmark EMPA-REG OUTCOME trial.1 New-onset or worsening kidney disease was a pre-specified composite endpoint that included the below clinical events. Compared with placebo, Jardiance led to the following statistically significant changes in outcomes:55 percent reduction in the initiation of kidney replacement therapy (such as dialysis)44 percent reduction in doubling of creatinine (a waste product usually filtered by the kidneys) in the blood38 percent reduction in progression to macroalbuminuria (very high levels of a protein called albumin in the urine) Jardiance also significantly slowed the decline in kidney function over time compared with placebo.1 Most patients in this trial were already taking the recommended standard treatment for kidney disease in type 2 diabetes, renin angiotensin aldosterone system blockade; the kidney effects of Jardiance® were apparent on top of these agents.1 Consistent risk reductions in kidney outcomes with Jardiance® were seen in people who had impaired kidney function, or increased levels of albumin in the urine, at baseline and in those who did not, according to a post hoc sub-group analysis.1 Serious adverse events (AEs) and AEs leading to treatment discontinuation for Jardiance versus placebo were comparable for those with or without impaired kidney function at baseline.1 Death due to kidney disease was rare and occurred in three patients treated with Jardiance (0.1 percent) and none treated with placebo. "With these new EMPA-REG OUTCOME data, Jardiance is the only SGLT2 inhibitor associated with evidence of slowing the progression of kidney disease in adults with type 2 diabetes and established cardiovascular disease in a cardiovascular outcome study," said Prof. Hans-Juergen Woerle, Global Vice President Medicine, Boehringer Ingelheim. ]]> <![CDATA[NuGEN Technologies appoints New CEO ]]> https://biospectrumindia.com/news/95/8438/nugen-technologies-appoints-new-ceo-.html https://biospectrumindia.com/news/95/8438/nugen-technologies-appoints-new-ceo-.html Fri, 17 Jun 2016 10:37:17 +0530 He succeeds Elizabeth Hutt who recently left to pursue another opportunity. Mr Sood comes to NuGEN from PerkinElmer, where he served as Vice President and General Manager of their life science instruments business spanning a portfolio of products in imaging, detection, tissue pathology, automation and NGS sample prep. Prior to his current role, Mr. Sood was the Chief Executive Officer of Boreal Genomics, a developer of "liquid biopsy" tools for non-invasive detection of tumor mutation profiles. Prior to that, Mr. Sood served as General Manager of the Automation and Electrophoresis business units at Agilent Technologies, where he commercialized several successful products in the sample prep markets. He holds master's degrees in both computer science and molecular biology. "Nitin's track record of success, technical expertise, and extensive experience in product commercialization made him the ideal person to lead NuGEN through its next phase of growth and innovation," said Jeff Bird, Chairman of NuGEN's Board of Directors and a Managing Director at Sutter Hill Ventures. "NuGEN's differentiated technology, extensive customer base and innovative pipeline of new products makes this an exciting opportunity for me," said Mr. Sood. "I look forward to working with the entire NuGEN team to serve our customers and support their breakthroughs in both research and diagnostic applications of genomics." NuGEN's products offer rapid and simple workflows for a broad range of next generation DNA and RNA sequencing applications, enabling highly sensitive detection of variants and expression levels from tissues, single cells and liquid biopsies. ]]> <![CDATA[New trial data of BMS' Opdivo support efficacy in recurrent mRCC ]]> https://biospectrumindia.com/features/95/8139/new-trial-data-of-bms-opdivo-support-efficacy-in-recurrent-mrcc-.html https://biospectrumindia.com/features/95/8139/new-trial-data-of-bms-opdivo-support-efficacy-in-recurrent-mrcc-.html Thu, 16 Jun 2016 12:28:48 +0530 Four abstracts presented at this year's American Society of Clinical Oncology (ASCO) conference in May have strengthened the body of research into Bristol-Myers Squibb's Opdivo (nivolumab), hailing it as the new standard of care in recurrent metastatic renal cell carcinoma (mRCC), according to analysts with research and consulting firm GlobalData. As explored in GlobalData's most recent renal cell carcinoma (RCC) report, Opdivo is set to help the RCC market hit $3.6 billion by 2023, and these recent data further explore the relationship between disease progression and the benefits of Opdivo treatment. Dr Maxime Bourgognon, GlobalData's Analyst covering Oncology and Hematology, states that trials producing such data have done much to demonstrate Opdivo's positive qualities, such as promising survival outcome rates, objective response rates, and toxicity. Dr Bourgognon explains: "Trials of Opdivo have measured the drug against Afinitor, a competitor in the mRCC space. For example, several studies have verified the association between response rate and survival in mRCC patients treated with Opdivo (Escudier et al. 2016; Motzer et al., 2016). "Abstracts from the Motzer et al. analysis revealed that patients are more likely to demonstrate tumor response with Opdivo compared to Afinitor, and tumor response is correlated with patient survival, meaning tumor response is clinically significant. In another study, McDermott et al. have reported promising long-term overall survival of patients treated with Opdivo during the course of the Phase I and II trials, which both preceded the pivotal Phase III Checkmate-025 trial (McDermott et al., 2016)." Dr Dan Roberts, GlobalData's Senior Analyst covering Oncology and Hematology, adds: "These long-term results support the initial data published in the New England Journal of Medicine in September 2015, and further demonstrate that Opdivo significantly improves survival with a good quality-of-life." ]]> <![CDATA[Zydus inks pact marketing pact with EczacÄ±baÅŸÄ±,]]> https://biospectrumindia.com/news/95/7975/zydus-inks-pact-marketing-pact-with-eczacba.html https://biospectrumindia.com/news/95/7975/zydus-inks-pact-marketing-pact-with-eczacba.html Thu, 16 Jun 2016 12:27:38 +0530 Zydus Cadila, a global healthcare provider and EczacÄ±baÅŸÄ± Ä°laÃ§ Pazarlama A.Å?. a leading healthcare company of Turkey have signed a strategic collaboration agreement to market biotech products in the Turkish market. The agreement involves the import of biosimilars which are currently unavailable in the country especially for the treatment of cancer and also paves the way for a long term strategic collaboration to produce and launch new products in the market. The agreement was signed at the headquarters of EczacÄ±basi Holding located at Kanyon Ofis in Istanbul by Mr Pankaj Patel, Chairman and Managing Director of Zydus Group, Dr Sharvil Patel, Deputy Managing Director of Zydus Group and Mr BÃ¼lent EczacÄ±baÅŸÄ±, Chairman of EczacÄ±baÅŸÄ± Holding, Dr Erdal Karamercan, CEO of EczacÄ±baÅŸÄ± Group, and Ms Elif Ã‡elik, EczacÄ±baÅŸÄ± Healthcare Group President. Speaking on the agreement, Mr Pankaj Patel stated, "We are glad to partner with EczacÄ±baÅŸÄ±, a leading group in the field of healthcare in Turkey, to make available biotech therapies for patients in Turkey. The long term agreement between both partners to enrich this collaboration through introduction of new products, will augur well for healthcare access beyond geographies." In his speech at the ceremony, Mr BÃ¼lent EczacÄ±baÅŸÄ± stated that as EczacÄ±baÅŸÄ± Group, they believe that new collaborations enabling innovation and creating added value in the field of healthcare are very important and also said, "Our target is to ensure that the important worldwide advances in the field of biotech products are simultaneously reflected and reach more people in our ccountry, and think that Zydus is a very right partner in this regard". ]]> <![CDATA[Mundipharma's Raman Singh listed among top five in global Power List ]]> https://biospectrumindia.com/news/95/7664/mundipharmas-raman-singh-listed-among-top-five-in-global-power-list-.html https://biospectrumindia.com/news/95/7664/mundipharmas-raman-singh-listed-among-top-five-in-global-power-list-.html Thu, 16 Jun 2016 12:27:18 +0530 Mr Raman Singh, president, Mundipharma Asia Pacific, Latin America, the Middle East and Africa, has been ranked the world's fourth most influential person in the pharmaceutical industry by the UK's Medicine Maker. This comes after Mundipharma achieved year-on-year growth of 79%, expanded its business hub in Singapore and begun construction of a R&D and manufacturing facility in the city-state. Mr Singh was among only two executives from the private sector, and the only Asian-based person, to be ranked within the top five. The Medicine Maker's Power List ranks the top 100 most influential people in the global pharmaceutical industry who inspire change by solving business problems, founding research and championing causes. It includes top executives, academics and other professionals from leading companies and prestigious institutions around the world. Mr Singh said, "Being named in this list is a reflection of the hard work put in across the whole company over a great year, and our vision for the future. Mundipharma is dedicated to ensuring that the emerging world has equal access to innovation as more mature Western economies." Earlier this year Mundipharma held a groundbreaking ceremony for its new R&D and manufacturing facility, which will serve emerging markets. It has also recently expanded its head office in another demonstration of the company's commitment to Singapore, the region and the emerging world. Mundipharma's 79% growth over the last year is the latest milestone in a continuous upward growth trajectory since Mr Singh joined Mundipharma in 2011. Total growth over that period stands at 459%. People on Medicine Maker Power List were evaluated and ranked by each individual judge on the judging panel. The rankings were then averaged to obtain the final Power List. ]]> <![CDATA[New merger between Pfizer, Anacor to leverage companies in Atopic Dermatitis space]]> https://biospectrumindia.com/features/95/7720/new-merger-between-pfizer-anacor-to-leverage-companies-in-atopic-dermatitis-space.html https://biospectrumindia.com/features/95/7720/new-merger-between-pfizer-anacor-to-leverage-companies-in-atopic-dermatitis-space.html Wed, 15 Jun 2016 14:01:00 +0530 An upcoming merger agreement between Pfizer and Anacor, worth around $5.2 billion, could boost the marketing power of Anacor's lead pipeline candidate, crisaborole, and pave the way for Pfizer to launch its own candidate, a topical form of Xeljanz, both for the treatment of mild-to-moderate atopic dermatitis, according to an analyst with research and consulting firm GlobalData. As explored in GlobalData's report on atopic dermatitis, with the expected launch in the second quarter of 2017 of Regeneron and Sanofi's dupilumab, the severe atopic dermatitis market is set to be a difficult one for new entrants to penetrate. Crisaborole, however, will not face serious competition as it enters a dormant mild-to-moderate atopic dermatitis market. Dr Abhilok Garg, GlobalData's Analyst covering Immunology, states: "Prior to Pfizer's interest in Anacor, GlobalData anticipated a US-only launch of crisaborole in 2017, with sales potential just shy of $200 million by 2024. However, Pfizer backing the launch of crisaborole across the seven major markets (7MM) of the US, France, Germany, Italy, Spain, the UK, and Japan, would substantially increase the available patient population for the drug, involving a further six million treatable patients by 2024." Despite this, the drug will still face competition. In anticipation of crisaborole's first-to-market advantage in the mild-to-moderate atopic dermatitis space, other companies targeting this portion of the market have taken steps to secure a position. Medimetriks, for example, has licensed a pipeline candidate from Otsuka and collaborated with Knight Therapeutics in order to strengthen its marketing potential. Crisaborole, however, leads the race to market, and has set itself apart from the competition with significant investment into proving its safety in pediatric patients, a largely underserved demographic. Dr Garg explains: "Pfizer now has the opportunity to build on the work of Anacor by utilizing its existing relationships with pediatricians and primary care physicians, and its experience in markets outside of the US. Indeed, this insight could serve to aid the company in its development of topical Xeljanz. Although further study into this drug is needed, its launch would result in Pfizer commanding a large portion of the mild-to-moderate atopic dermatitis patient population. "GlobalData expects crisaborole to encounter a drug-treated market size of 3.1 million mild-to-moderate atopic dermatitis patients by 2024 in the US. With the backing of Pfizer and potential entry into the rest of the 7MM, crisaborole could gain access to a total of approximately eight million drug-treated mild-to-moderate patients by 2024, of which approximately 60% would be pediatric or adolescent." ]]> <![CDATA[Exclusive: Does India need a Precision Medicine Initiative?]]> https://biospectrumindia.com/features/95/8406/exclusive-does-india-need-a-precision-medicine-initiative.html https://biospectrumindia.com/features/95/8406/exclusive-does-india-need-a-precision-medicine-initiative.html Wed, 15 Jun 2016 12:39:58 +0530 During his State of the Union address in January 2015 at the White House in Washington DC, American President Mr Barack Obama announced the launch of the most ambitious Healthcare initiative called the Precision Medicine Initiative (PMI), a mission to usher the US into a new era of medicine where patients will enjoy individualized and tailor-made treatments for various ailments. Mr Obama said, "Doctors have always recognized that every patient is unique, and doctors have always tried to tailor their treatments as best they can to individuals. You can match a blood transfusion to a blood type - that was an important discovery. What if matching a cancer cure to our genetic code was just as easy, just as standard? What if figuring out the right dose of medicine was as simple as taking our temperature?" Too Early For India? Precision medicine is an emerging approach of medicine which looks at the root cause of an illness, rather than addressing the symptoms alone. Precision medicine may not be very well known as Personalized Medicine. But they are one and the same. It takes into account individual variability in genes, environment, and lifestyle for each person. The need and its potential in the Indian Healthcare scenario is high, considering that the system is under great pressure due to sheer numbers. Precision Medicine in the country is considered to be at an early adoption stage. A diverse country like India, with over 4000 population groups, and a significant percentage of consanguineous marriages presents a high-risk and prevalence of inherited genetic disorders that require attention for early diagnosis, right treatment, and management. India has a heavy burden of inherited diseases driven by the unique genetic characteristics in the population. With 1.4 billion people, the absolute number of patients suffering from diseases in which genetics play a role is significantly large. It is reported that Indians witness a loss of around $23 billion from their annual income in treating or getting tested for non-communicable diseases. The global Genomics industry is predicted to grow at around 18% in the next 10 years, and India is expected to be a major stakeholder. Revenue growth in molecular diagnostics in 2013 was reported to be around 15%. Clinical diagnostics in one of the fastest growing fields which may cross $2 billion by 2018. Preventive healthcare is growing at the rate of 25%, which will boost Healthcare revenues and the country's Precision Medicine scenario. "Genetic testing is slowly getting acceptance among our clinicians. The challenges are about creating the awareness for wide-spread adoption. It is not at all too early for the country to embrace precision medicine. This is primarily because India is an emerging market for genomics. A rising middle-class, state-of-art healthcare facilities and expert physicians are driving the growth of the industry in India.... I expect the industry to attain double digit growth," says Mr Sam Santhosh, Chairman & Global CEO, MedGenome. Dr Saleem Mohammed, CEO & Founder, Xcode Life Sciences, agrees that India has a strong need for Precision Medicine which will significantly reduce its Healthcare burden. "It is estimated that only around 40% of the medicines we take are effective and appropriate for us. Today, we practice trial-and-error medicine which does not consider in detail the person-to-person variability, which is a key source of variation for the effectiveness of drugs. You can imagine being dosed and prescribed by taking into account various factors such as age, gender, genetics, medical conditions and usage of other drugs. That is the promise of personalized medicine, and India needs to take leadership in this domain," he adds. In India, Precision Medicine is being practiced in several specialties like oncology, cardiology, psychiatry and diabetology. It is already being embraced in India to a reasonable extent, especially in cancer. "Each individual is an island, and so now that the molecular complexity of disease has been deciphered, the role of genetics, environment and epigenetics are clearly telling us that that we all need to receive treatment designed for our physiology and body type," remarks Dr Villoo Morawala-Patell, Founder & CMD, Avesthagen. Indian Healthcare institutions are fast adopting technologies that can make them on par with the best in the world. The need to modernize, and be on par with global standards can be seen amongst large hospitals and private medical institutions. Explains Dr Kalyanasundaram Subramanian, CSO, Strand Life Sciences, "There are several targeted therapies that work only on patients who have a specific genotype or genomic variation. So, patients are tested before the therapy is prescribed. Cancer is probably the disease in which precision medicine is most advanced. However, there are several other diseases - cardiac, ophthalmic, and certain types of diabetes, where knowing the genetic background of the disease can help with disease management. Here the field is not as advanced." Like most technologies, India is expected to be a follower-market in Precision Medicine. Doctors would like approval from USFDA or the American Medical Association (AMA) for it to become mainstream in their practice. But the challenge is that the West is going to fund studies in Caucasian population and not the Indian. In fact, most drugs are designed and manufactured for Caucasian population. Unless India accelerates research in this space, validation in the Indian context will always be questionable. "Precision medicine is badly needed to move towards personalized medicine and personalized diagnostics, which has a huge potential to reduce the burden of national healthcare costs," points Dr Amit Kumar, CEO & CSO, BioAxis DNA Research Centre. "At several instances, this results in patients selling assets or borrowing money to pay incurring medical expenses. Precision medicine is the best available tool and remedy for combating this huge economic burden." Cost of these tests are a concern still, given India is largely a self-paid economy. But as technologies improve, the cost of sequencing is seen to reduce. Precision Medicine offers a possible answer by reducing the costs of hospice stay, and reducing the overall financial, physical and psychological costs of the try-and-test approach of medicine. "The infrastructure needed for precision medicine is taking shape in India. There are certain issues to be addressed for it to gain the needed momentum," opines Mr Samarth, CEO & Founder, Positive Bioscience. "The key is also the analysis of genomics data, which as we automate will provide higher efficiency in the entire data analysis process, thereby making tests more affordable. We do need more baseline genomics data of Indian origin which will help us in refining our analysis on clinical cases in the country," comments Mr Sam. Targeted therapies like Imatinib have been around for 40 years. This has changed the prognosis of Chronic Myeloid Leukemia (CML) in children. "People used to think that the role of genetics ended with hereditary disease. Today we know that every response our body makes has a genetic fingerprint to it. We can now predict response to different therapies, and thus avoid trial-and-error medicine which is both costly, time-consuming, and puts an unnecessary drug and hospitalization burden on the patient," comments Dr Sooraj Ratnakumar, Founder & Scientist, Swagene. The US and EU markets do have a head start in Personalized Medicine in terms of accessibility to resources and raw materials, government funding, and regulations. "There is also greater awareness among the people there about the benefits of personalized medicine. In India, we have an excellent gene pool of biotech and IT professionals. With government interest, we can easily build India as the hub of personalized medicine," expresses Ms Anu Acharya, CEO, Mapmygenome. President, CEO & Founder of Genotypic Technology Mr Raja Mugasimangalam says that Precision Medicine is too early for India at the moment. "Precision medicine is an emerging field and sufficient success should be shown by the western world for India to embrace it. It is in its early phase, and there is not sufficient government support in the form of research grants in this space," he adds. Overly Hyped? The way Precision Medicine can help transform Healthcare, especially treatment and management of deadly non-communicable diseases is tremendous, and stalwarts opine that it is not an overly hyped concept. "The field of precision medicine is still in a nascent stage in India, and much needs to be done to create awareness. So the concept cannot be called as overly hyped, but rather passionately acclaimed in the medical and scientific fraternity. Any development in the science and medical space that revolutionizes how medicine will be practiced in the future naturally generates a buzz around it. Yes, the concept is quite novel at this point of time but its scope is tremendous. While we may lack the bandwidth to carry out all the exceptional research at this point in time, slowly it will happen. And once it happens, the impact will be more than just overwhelming. However, there are certain roadblocks that we cannot ignore. But limitations and challenge begets innovation and development," opines Mr Samarth. "I see precision medicine as a new hope rather than a hype," Dr Amit states. "Some of our clients say that research insights of the genomics data-related to lifestyle, diet, and clinical methods have been very useful in making a decision faster based on a patient's personalized genetic information." More than hype, Precision Medicine is said to be more of plain, pure common sense. For thousands of years, humans have known that there is inter-individual variability when it comes to things ingested, be it medicine or food. Why then patients pop an over-the-counter pill? Or even wonder whether it will work on them or not? In a recent study by Johns Hopkins University (USA), medical error was suspected to be the third leading cause of death in the US. Many of them are related to improper drugs and improper drug dosages. "It's sort of like 'death by medicine'. Can you imagine what the statistics are in India? asks Dr Saleem. "Today, we don't question why the outcome was negative for a patient. We assume that the medical establishment did the best they can in good faith. With increasing prevalence of clinical decision support systems, and insurance insisting on good practices, you will see things improve. Common sense dictates that precision medicine is the only way medicine should be practiced and not by trial-and-error." Dr Binay Panda, Chief Officer & Head, Ganit Labs, also states that the problem in India is that Precision Medicine is hyped by people who understand little about it. "Look around and you will find folks who talk about precision medicine, who understand little about it or have very little practical and scientific experience on developing precision medicine tests. We need rigorous scientific minds to talk about the utility of precision medicine, like in the west, and not those who use the term as a buzz word or a part of marketing supplements only," clarifies Dr Binay. India's Research Scene The research scene for Precision Medicine in India is largely in the beginning stage. Some studies are being carried out in various translational research centres across the country. There are several Government laboratories such as IGIB (Institute of Genomics & Integrative Biology), CCMB (Centre for Cellular and Molecular Biology), hospitals such as CMC Vellore, LV Prasad Eye Institute and other organizations, where research is being conducted. "However, it would be fair to say that the research is fragmented and individual researcher-driven, and not yet translated to patient care in a big way," points Dr Kalyanasundaram. Research is also being carried out at Sir Gangaram Hospital (Delhi), Madras Diabetes Research Foundation (MDRF) (Chennai), Indian Council of Medical Research (ICMR), Institute of Bioinformatics (IOB) (Bangalore), and Government institutions such as National Institute of Biomedical Genomics (NIBMG) and Center for Genome Research. Large Government hospitals like Tata Memorial Hospital, National Institute of Mental Health and Neurosciences (NIMHANS), and All India Institute of Medical Sciences (AIIMS) are also involved in the identification of new disease genes and biomarkers by applying Genomics. Dr Mallik Sundaram, Co-founder, President & CEO, Mitra Biotech, says, "The western markets have embraced it quickly because healthcare is more organized there with the payers being the government or insurance companies, thereby translating the benefits of decreased healthcare costs while improving treatment success rates using precision medicine. In countries like India with fragmented healthcare, and the patient frequently being the payer, while the benefits remain the same, but acknowledging and translating them is more piecemeal." India, like many other developing countries, is following success stories of the West. "Success in precision medicine depends on several factors including availability of tests on precision medicine, system on which medical payment is made -- out-of-pocket versus insurance-based versus government-sponsored -- overall positive atmosphere in the country towards embracing new tests, previous success stories, availability of skilled manpower and the presence of the right environment. On all these accounts, we in India, have miles to go. However, we have excellence in pockets, which include brilliant people who are capable of doing all that. The trick is to encourage those few to develop tests for the Indian population," Dr Binay explains. Paradoxical Elements The use of Precision Medicine is a little tricky and paradoxical, say experts. "It has lot of social impact. But someone has to draw a line to the extent one should use it. One single mutation is responsible for more than one medical condition and vice versa; it may also create confusions and misleading interpretations. Precision medicine may be only a corroborative aspect until we have more confidence, and accurate outcomes getting reported across the globe," Dr Amit reveals. Dr Kalyanasundaram says that the challenge is in marrying personalization of medicine with reduced drug costs to an individual patient. "Currently, most of the best genome-based medicines are expensive and out-of-reach for the average Indian. The other worrying aspect is that none of these medicines are available in India. Imagine the plight of a patient who realizes that there are medicines that may work for him but is unable to access it," he observes. Also, the discussion of paradoxes of Precision Medicine often revolves around the cost, i.e., spending more and more to identify therapies that applies to fewer and fewer. Mr Samarth adds, "This paradox can be compared to the cost of any IT initiative in the eighties era using mainframe computers, and specially created buildings for housing them versus, even higher computational processing being available today in a mobile system; or 3D printing to give a more recent example. As there is a change in approach and increase in use of the technologies, there will be a reduction in costs." What Is Needed? In Precision Medicine, for successful commercialization, many things have to come together. "There has to be a way of leveraging all the information and insights that is generated in other populations from around the world. The Indian government should be setting up large genomic studies in various disease populations. Indian scientific establishments needs to view this as a challenge, and work with physicians to understand the diseases that are most likely to have benefits quickly, and work towards problems in those areas. Indian funding agencies should be funding large translational projects with a clear clinical aim. There should be clear frameworks that allow industry to access these insights to convert them to products," urges Dr Kalyanasundaram. Both Mr Sam and Mr Samarth agree that increasing the awareness levels of Precision Medicine among the general population, clinicians and doctors is much needed. "In our country, the depth and width of the healthcare system is very large, often unorganized, and under tremendous pressure. To bring in a new approach to the practice of medicine will need full participation and education of patients, drug developing pharma companies in pharmacogenomics, change in the practices and process of hospitals and clinics, good regulatory framework and the support of the government in building the research infrastructure. Further in order to translate the bench research to bedside care, it is important for research academics and medical market players join hands," suggests Mr Samarth. Collaboration of genetic testing laboratories, hospitals, and medical doctors may be the starting point, says Dr Amit. "We require huge genetic, clinical and lifestyle data from India, and this can only be reached if governmental programs backup such kind of association and research. With the fast decreasing cost of DNA sequencing of a person's genome, a model shall be framed which should have genetic medicine and precision therapy as one of the most important inclusion. Government may think of including genetic tests under the insurance coverage, starting with critical illnesses. If we have enough country data, it may offer a lot of very important medical insights." According to Dr Binay, India needs 4 Ps to make Precision Medicine succeed. "They are people, processes, protocols and pricing. People meaning encouraging and aiding brilliant minds to be involved in developing new and innovative tests; processes meaning developing the right clinical and scientific processes or SOPs; protocols meaning coming up with the right regulatory...," he lists. Dr Saleem believes that the medical community should actively collaborate with genetic service providers to validate concepts in the Indian population. "We operate in a highly cost-sensitive environment. A key barrier to adoption is cost of the test.... In the long-term, genetics should become a major part of the medical curriculum. Genetics should get its due importance given that we live in an era where we are talking about actively editing genes to cure major diseases," he notes. Mr Sam recommends public-private partnerships (PPP) between academic institutes and the industry to promote genomic research in the country. "Partnerships with private enterprises that have already taken the leap into genomics research and are providing solutions to address health care needs in India.... In addition to this, initiatives like setting up of electronic medical records, and population level genome sequencing will go a long way in helping commercial success. It will also be useful to chart out a comprehensive plan to identify key disease areas in India with underlying genetic reasons that have high unmet medical need and to allocate government funds to promote education, research and innovation in these areas," he stresses. Should India Ape The US? India may follow something similar to PMI launched by Mr Obama, but on a pilot scale. "The government can play a key role by allocating research funding to this area. Precision medicine is going to have a tremendous impact on our nation's healthcare and will improve health outcomes while minimizing the costs. But someone has to make the investment in accelerating the creation of know-how, and the knowledge base that is specific to India. Given the significance of health for a nation's economic and social development, I would say that prioritizing of government grant funding to this area will be highly useful. The US again has taken leadership in this so far with the precision medicine under the Obamacare," voices Mr Samarth. In an interview with BioSpectrum, Dr Mandar Kulkarni, CTO, Cancer Genetics India, states, "I think this is a big challenge even in the US, where most diagnostic testing is paid through insurance reimbursements, which are driven by FDA-approvals." He further expresses, "Currently, the FDA is reviewing the guidelines and ensuring that the testing is not wasteful. On the other hand, a major advantage for such testing in the US is the availability of well-curated databases that define the effect of mutations on the disease-state in terms of prognosis, clinical outcome and treatment options. Unless we adopt the tests and begin this exercise, we will not be able to identify epidemiological and etiological differences that contribute to cancer in India." Though India's limited studies in this area show that while the Indian genome has many similarities to the Caucasian, there are significant differences as well. "So it is absolutely essential that a similar and large PMI be launched in India given the genomic diversity here," justifies Dr Kalyanasundaram. Mr Sam also agrees that a initiative like PMI will be useful to India's Healthcare. "If a similar program is initiated, it has to be designed keeping in mind the state of the economy, and the public health issues of the Indian population, and the diseases or disorders plaguing our society. The GenomeAsia 100K consortium is one such initiative in the region," he urges. Starting anything new is good, but India needs to revive and encourage what it already has, and have a long-term vision for Personalized Medicine. "Science does not bear fruit overnight," Dr Binay adds. "One needs to be patient and encourage funding the right talent in this direction. First and foremost, we need to encourage young minds to pursue science and be more meritocratic in our institutions." Dr Amit emphasizes that both ICMR (Indian Council of Medical Research) and CSIR (Council of Scientific and Industrial Research) need to play a very important role in framing the insights related to pharmacogenomics, genetic variation-related drug studies, and population-wise human SNP validation, if India wants a meaningful outcomes from such a diverse population. Dr Raja says that India doesn't have to ape the West. One might consider a PMI in India as an overly zealous move for a country where malnutrition and poverty collectively kills more people than diseases. "At the right time we can definitely think of taking a step towards PMI for our own country just like America. India is already the diabetes capital of the world and is slowly inching in vying the top spot for heart ailments and cancer too. I think we all have come to appreciate the fact that all these diseases are genetic-driven by a combination of several mutations in different genes. Precision medicine guided by genomics not only allows us to diagnose and prevent these diseases but also treat and manage them effectively," elaborates Mr Samarth. Regulatory Woes Genomic information is critical since it not only affects an individual but potentially their family as well. There are legal, technical, social, and political hurdles which needs to be addressed. Dr Kalyanasundaram stresses, "It needs to be clear who owns this information, what are the limitations under which researchers get access to it, and how can this information be used and misused. These issues are all critical and need to be addressed by the law." However, the current regulatory frameworks are inadequate in terms of providing guidelines for Precision Medicine initiatives. Information is required on how to bring in a population level-approach for Genomics research. Also, policy revisions to support the industry from import duties on reagents are a need of the hour. "Intellectual property rights and patent policies are not very well defined in the area of precision medicine and predictive genomics. This could be a challenge to further innovation. Also, reimbursement from insurance companies is another key factor that will determine the growth of this industry. In the western world, insurers have started accepting genomic tests in their formulary as it is expected to reduce the cost of down-the-line treatment. In India the option is to bring the test at affordable prices and foster innovation to reduce the cost of genomic diagnosis," Mr Sam expresses. Precision Medicine is dependent on the DNA Study of an Individual, and India does not have a DNA usage policy yet. "We are hoping for the best since this important master molecule has caught the attention of our PM Narendra Modi, and he has announced to put all the efforts towards the DNA Bill of India. Again, draft of this Bill also needs to be concreted by including insights from industry experts, academicians, research organizations, laboratories and judiciaries," justifies Dr Amit. Dr Binay strongly supports in having strong ethical guidelines to practice Precision Medicine. Degree Of Impact Just imagine a patient taking a simple blood or saliva test at a laboratory, and in the next meeting his or her physician is very well prepared with the patient's genetic horoscope including the information on chemical compounds, or combination of drugs useful or harmful to him, based on the tried-and-tested genetic test report. "We will be able to minimize side effects with very beautiful and faster accurate therapies that too at affordable costs if precision medicine boosts up in India..... If used responsibly, it can do wonders and contribute towards every individual's good health," notes Dr Amit. Precision Medicine can also transform the national economy, especially in a population whose average lifespan is increasing. Mr Sam explains, "From an individual's perspective, it has the potential to make genetic diagnosis of diseases more efficient and cost-effective, by reducing genetic testing to a single analysis, which informs individuals throughout their life. Since it uses state-of-the-art genomic technologies, rich medical record data, tissue and blood banks, and clinical knowledge that will allow clinicians and payers to tailor treatments to individuals, it can greatly reduce costs of ineffective therapies incurred through the current trial-and-error clinical paradigm." The impact can be great, where patients get the right medications, have better outcomes and lower side effects, feels Dr Kalyanasundaram. "This would lead to healthier populations with better overall health economics. To make this possible, lots of information needs to be collected, analyzed and translated. Medicines that can exploit the genetic differences need to be present. So the task is formidable but the payoffs are potentially enormous." Precision Medicine will also allow reduced morbidity, specifically in oncology cases, help in preventing high burden of genetic diseases, and managing high-risk cases with increased surveillance. It will also have a major impact on the economy by reducing productivity losses, and decreasing costs of treating disease, thereby reducing overall costs on Indian Healthcare. "The internet will further accelerate adoption of precision medicine by empowering patients and doctors who are already demanding more to fight India's unique challenges with diabetes, heart disease and tobacco use," said Dr Sooraj. In 2012, Futures Group predicted a new perspective to Healthcare by 2050, where gaps between medical practice, healthcare, and personal health will be bridged. Another prediction is the predominance of preventive healthcare, where individuals take charge of their health by harnessing the power of technology. Genomic tests - single nucleotide polymorphism and whole genome sequencing - will be the key catalysts to this change. "We have seen the beginning of this change. Wellness was once a fancy word. Today, it is part of every hospital's business strategy to engage a new generation of customers, who are actively pursuing wellness using social apps for various reasons - right from fitness and diet to finding the best doctor," opines Ms Anu. In India, diseases have a profound physical, psychological and social impact. Most of healthcare costs are paid not out of insurance, but out of pockets. The impact of illness in one person in the family has a domino effect on the family and the community. "The cost of treatment, for diseases like cancer, cardiac diseases, diabetes, asthma, and the impact of the side effects of medication taken has often seen families, even amongst middle-class and higher middle-class, needing to take loans, or family members having to leave jobs," Mr Samarth states. "Just the simple factor of reducing treatment time and side effects will have a significant impact on the socio-economic situation of an individual." So, diseases that were previously a death sentence will be manageable, or even curable, because we will be able to individualize therapy for each patient. ]]> <![CDATA[Meningococcal vaccines market set to approach $1.8 bn by 2025]]> https://biospectrumindia.com/features/95/7315/meningococcal-vaccines-market-set-to-approach-1-8-bn-by-2025.html https://biospectrumindia.com/features/95/7315/meningococcal-vaccines-market-set-to-approach-1-8-bn-by-2025.html Tue, 14 Jun 2016 11:02:22 +0530 The meningococcal vaccines market is expected to grow from around $1.1 billion in 2015 to $1.8 billion by 2025 across the eight major markets (8MM) of the US, France, Germany, Italy, Spain, the UK, Japan, and Brazil, representing a compound annual growth rate of 5.4%, according to research and consulting firm GlobalData. The company's latest report states that this substantial growth will mainly be driven by adjustments in national immunization schedules, as governments implement more inclusive vaccination schedules to prevent invasive meningococcal disease. It will also be propelled by the anticipated launch of a first-in-class vaccine covering all serogroups currently prevalent in the 8MM by combining two different meningococcal vaccines, thereby decreasing the dosage burden involved in vaccinations. Dr Mirco Junker, GlobalData's Analyst covering Infectious Diseases, says: "Although the meningococcal vaccine market in the 8MM is highly mature, and the continuous decline in incidence rates of meningococcal disease across most of these countries will act as a barrier to launching new products, there will be several opportunities for a current or future player to distinguish itself from the competition. "For example, the meningococcal vaccines market is characterized by a large diversity of vaccines, with each covering only a specific serogroup or a set of serogroups. However, the epidemiology of serogroup distribution varies by country and over time. Therefore, providing a single vaccine that can protect the population against all prevalent serogroups will represent the most important opportunity to access a larger market share during the forecast period, by reducing the number of vaccines required to prevent meningococcal disease." Traditionally, the meningococcal vaccine marketplace has been dominated by Big Pharma, with Sanofi, GlaxoSmithKline (GSK), Pfizer, and Novartis providing the majority of commercially available vaccines over the past decade. In the last few years, the meningococcal vaccine market has experienced additional changes, after Novartis sold its meningococcal vaccine portfolio to GSK, and after the recent launch of GSK's Bexsero and Pfizer's Trumenba, the first two vaccines to offer protection against serogroup B. Dr Junker concludes: "GlobalData expects that GSK will pass Sanofi as the main provider of meningococcal vaccines by the end of this forecast period. This growth in the company's market share will be driven by Bexsero, which will hit sales of over $570 million in 2025, as well as their novel pentavalent vaccine, MenABCWY, which is expected to launch in the US and five European countries during the forecast period." ]]> <![CDATA[Merck to acquire Afferent Pharmaceuticals ]]> https://biospectrumindia.com/news/95/8349/merck-to-acquire-afferent-pharmaceuticals-.html https://biospectrumindia.com/news/95/8349/merck-to-acquire-afferent-pharmaceuticals-.html Mon, 13 Jun 2016 14:04:40 +0530 Merck, known as MSD outside the United States and Canada, and Afferent Pharmaceuticals announced that the two companies have signed a definitive agreement under which Merck will acquire this privately held pharmaceutical company. Afferent Pharmaceuticals is a leader in the development of therapeutic candidates targeting the P2X3 receptor for the treatment of common, poorly-managed, neurogenic conditions. Afferent's lead investigational candidate, AF-219, is a selective, non-narcotic, orally-administered P2X3 antagonist currently being evaluated in a Phase 2b clinical trial for the treatment of refractory, chronic cough as well as in a Phase 2 clinical trial in idiopathic pulmonary fibrosis (IPF) with cough. "Afferent has pioneered the clinical development of novel investigational candidates selectively targeting the P2X3 receptor, an exciting area of research," said Dr Roger M Perlmutter, president, Merck Research Laboratories. "We look forward to advancing these innovative molecules for patients with conditions like chronic cough, an area of significant unmet medical need." Under terms of the agreement, Merck, through a subsidiary, will acquire all outstanding stock of Afferent in exchange for an upfront payment of $500 million in cash. Also, Afferent shareholders will be eligible to receive a total of up to an additional $750 million associated with the attainment of certain clinical development and commercial milestones for multiple indications and candidates, including AF-219. "This achievement is a reflection of the talent and hard work of the experienced Afferent team in advancing the science of P2X3 receptors and the clinical development of our novel therapeutic candidates," said Ms Kathleen Sereda Glaub, chief executive officer, Afferent Pharmaceuticals. "We are very pleased to enter into this agreement given Merck's reputation for maximizing opportunities around novel mechanisms. This agreement with Merck creates significant value for Afferent shareholders while enhancing the potential of our portfolio to provide meaningful benefits to patients globally." Data on cough frequency from the first cohort of a Phase 2b dose-escalation clinical trial of AF-219 in patients with chronic cough were presented at the 2016 American Thoracic Society (ATS) International Conference. The results of the second cohort, which is examining lower doses, are expected to be presented at a future scientific congress. The closing of the transaction will be subject to certain conditions, including the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act and other customary conditions. The companies anticipate the transaction will close in the third quarter of 2016. ]]> <![CDATA[Dr Reddy's to acquire product portfolio from TEVA for US Market]]> https://biospectrumindia.com/news/95/8230/dr-reddys-to-acquire-product-portfolio-from-teva-for-us-market.html https://biospectrumindia.com/news/95/8230/dr-reddys-to-acquire-product-portfolio-from-teva-for-us-market.html Mon, 13 Jun 2016 14:04:18 +0530 Dr Reddy's Laboratories has entered into a definitive agreement with Teva Pharmaceutical Industries and an affiliate of Allergan to acquire a portfolio of eight Abbreviated New Drug Applications (ANDAs) in the US for $350 million in cash at closing. The acquired portfolio consists of products that are being divested by Teva as a precondition to its closing of the acquisition of Allergan's generics business. The acquisition of these ANDAs is also contingent on the closing of the Teva/Allergan generics transaction and approval by the US Federal Trade Commission of Dr. Reddy's as a buyer The portfolio being acquired is a mix of filed ANDAs pending approval and an approved ANDA, and comprised of complex generic products across diverse dosage forms. The combined sales of the branded versions of the products in the U.S. is approximately $3.5 billion MAT for the most recent twelve months ending in April 2016 according to IMS Health*. Mr G.V. Prasad, co-chairman and CEO of Dr. Reddy's Laboratories, commented, "This transaction will add strength to our product portfolio, help us be more relevant in our U.S. market and also create new opportunities for growth." Mr Alok Sonig, Executive Vice president and Head of North America added, "Dr Reddy's Laboratories has a strong track record in the US market with over 79 filed ANDAs pending approval, of which we believe 18 have first-to-file status. The acquisition of these attractive ANDAs from Teva will enhance our short-to-midterm aspirations and is consistent with our growth initiatives to identify inorganic opportunities to expand our base business." Dr Reddy's Laboratories is acquiring the portfolio on a cash-free, debt-free basis and expects to finance the transaction using a combination of cash on hand and available borrowings under existing credit facilities. ]]> <![CDATA[New drug Rova-T Set to revolutionize SCLC Space?]]> https://biospectrumindia.com/features/95/7148/new-drug-rova-t-set-to-revolutionize-sclc-space.html https://biospectrumindia.com/features/95/7148/new-drug-rova-t-set-to-revolutionize-sclc-space.html Mon, 13 Jun 2016 14:03:55 +0530 Recent data from the 2016 American Society of Clinical Oncology (ASCO) annual meeting have shown that rovalpituzumab tesirine (Rova-T), AbbVie's antibody-drug conjugate (ADC) to treat recurrent/refractory small cell lung cancer (SCLC), represents a promising new approach, as it is the first biomarker-directed therapy for treating the disease, according to an analyst with research and consulting firm GlobalData. SCLC is an aggressive form of lung cancer that accounts for approximately 15% of all lung cancers. As explored in GlobalData's most recent small cell lung cancer report, there is an urgent need for effective therapies in the disease, as the currently available treatment options remain limited. Dr Volkan Gunduz, GlobalData's Analyst covering Oncology & Hematology, explains: "By attaching a powerful chemotherapy that is too potent to administer on its own to an antibody that detects delta-like protein 3 (DLL3), Rova-T delivers the payload directly to cancer cells. Importantly, DLL3 is not present in healthy tissue but is expressed in more than 80% of SCLC patient tumors, making it a highly specific biomarker for SCLC." The most promising aspect of data from the Phase I/II trial is the discovery of a biomarker that could predict the efficacy of a targeted therapy for treating SCLC. In 74 patients enrolled in this trial, 88% had DLL3 expression on â‰¥1% of tumor cells, meaning that majority of the patients with SCLC may benefit from this therapy. Dr Gunduz continues: "AbbVie has an ambitious clinical program for Rova-T and has already initiated the potentially registrational Phase II TRINITY trial investigating the efficacy of Rova-T as a third-line treatment in DLL3-expressing SCLC. The preliminary results of this trial could serve as the basis for an FDA approval in 2017, making Rova-T the first targeted drug ever approved for SCLC. "As this is an indication with high unmet need that has no currently approved third-line therapies, GlobalData expects Rova-T will be a strong revenue booster for AbbVie, helping to offset the patent expiry of its top-selling anti-inflammatory drug, Humira (adalimumab), in the last quarter of 2016." GlobalData estimates that the SCLC market across the seven major markets of the US, France, Germany, Italy, Spain, the UK, and Japan was worth $198 million in 2014 and will expand rapidly to reach $2.29 billion by 2024. ]]> <![CDATA[Thailand: First Asian country to eliminate mother-to-child transmission of HIV, Syphilis]]> https://biospectrumindia.com/news/95/7098/thailand-first-asian-country-to-eliminate-mother-to-child-transmission-of-hiv-syphilis.html https://biospectrumindia.com/news/95/7098/thailand-first-asian-country-to-eliminate-mother-to-child-transmission-of-hiv-syphilis.html Fri, 10 Jun 2016 17:58:07 +0530 The Minister of Health of Thailand was presented with the certificate of validation during a ceremony which took place in New York on the eve of the United Nations General-Assembly High-Level Meeting on Ending AIDS. "This is a remarkable achievement for a country where thousands of people live with HIV. Thailand's unwavering commitment to core public health principles has made elimination of mother-to-child transmission of HIV and syphilis a reality, a critical step for rolling back the HIV epidemic. Thailand has demonstrated to the world that HIV can be defeated," Dr Poonam Khetrapal Singh, Regional Director, WHO South-East Asia Region, said presenting the certificate of validation to Thailand in New York. According to Thailand's Ministry of Public Health 98% of all pregnant women living with HIV have access to antiretroviral therapy and the rate of mother-to-child transmission of HIV has been reduced to less than 2%. "Thailand has turned around its epidemic and transformed the lives of thousands of women and children affected by HIV," said UNAIDS Executive Director, Mr Michel SidibÃ©. "Thailand's progress shows how much can be achieved when science and medicine are underpinned by sustained political commitment." Untreated, women living with HIV have a 15-45% chance of transmitting the virus to their children during pregnancy, labor, delivery or breastfeeding. However, that risk drops to just over 1% if antiretroviral medicines are given to both mothers and children throughout the stages when infection can occur. "By investing in strong maternal and child health care and national AIDS prevention measures, Thailand has demonstrated there are ways to protect children from the global AIDS pandemic response," said Ms Karin Hulshof, Regional Director, UNICEF East Asia-Pacific Region. "Thailand's achievement inspires its neighbors to greater action. There are still 21,000 infants who are born with HIV each year in the Asia-Pacific region, and more than 200,000 children who are growing up with HIV." In 2000, an estimated 1000 children became infected with HIV. In 2015, the number of children who became infected with HIV through mother to child transmission was reduced to 85, a decline of more than 90%, a significant achievement in a country where an estimated 450 000 people were living with HIV in 2014. At the same time, sustained efforts and success in preventing new HIV infections have helped reduce HIV among women of childbearing age. According to Thailand's health authorities, between 2000 and 2014, the annual number of women newly infected with HIV fell from 15,000 to 1,900 - an 87% reduction. Thailand's Universal Health Coverage framework ensured essential health services were available to both rich and poor. The country's commitment to equitable access has ensured that both Thai citizens and migrants are covered for HIV treatment. Thailand's commitment to the UNAIDS-led 'Global Plan towards the elimination of new HIV Infections among children by 2015 and keeping their mothers alive', combined with the Government's decision to provide all pregnant women - including documented and undocumented migrant workers - free antenatal care, delivery and services for HIV and Syphilis pushed treatment coverage rates up, culminating in validation of elimination of mother-to-child transmission. Thailand's pioneering success and leadership demonstrates how countries can make real change when good policy is followed up with high-level commitment. WHO, UNAIDS and UNICEF will continue to work with other countries in the region, along with partners to replicate Thailand's success. In 2014, WHO and key partners published the guidance on global processes and criteria for the validation of the elimination of mother-to-child transmission of HIV and Syphilis, which outlines the validation process and the different indicators countries need to meet. As treatment for prevention of mother-to-child-transmission is not 100% effective, elimination of transmission is defined as a reduction of transmission to such a low level that it no longer constitutes a public health problem. An international expert mission convened by WHO visited Thailand in April 2016 to validate the progress toward the elimination of mother-to-child transmission of HIV and Syphilis. The members visited health centres, laboratories, and government offices, and interviewed health officials and other key actors. The mission included experts from Australia, Cambodia, China, Philippines, India, Indonesia, Nepal, Thailand, United States and representatives from WHO, UNICEF and UNAIDS. ]]> <![CDATA[AstraZeneca off-loads anesthetic portfolio to Aspen]]> https://biospectrumindia.com/news/95/7161/astrazeneca-off-loads-anesthetic-portfolio-to-aspen.html https://biospectrumindia.com/news/95/7161/astrazeneca-off-loads-anesthetic-portfolio-to-aspen.html Fri, 10 Jun 2016 15:44:00 +0530 British drug giant AstraZeneca has sold market rights to its portfolio of seven anesthetic medicines worth $770 million to South African firm Aspen Group outside the US. Aspen,South Africa's largest drug maker, operates in 50 countries and employs more than 10,000 people. As per the terms, Aspen will pay $520 million upfront for the products, which include general anesthetic Diprivan and local anaesthetic Marcaine. An extra $250 million could be paid in installments over the next two years, dependent on sales, as well as double-digit percentage trademark royalties. The news comes a a day after Aspen secured a â‚¬3 billion funding boost. It has spent more than $2 billion on acquisitions from pharma firms including GlaxoSmithKline and Merck over the past few years. AstraZeneca will continue to manufacture and supply the products on a cost plus basis to Aspen for an initial 10 years. The products are sold in more than 100 countries, including China, Japan, Australia and Brazil, and currently bringing in revenues of $592 million a year. The company's CEO, Mr Pascal Soriot mentioned that the deal will hep Astra focus on its three main therapy areas-oncology, respiratory, and cardiovascular and metabolic disease and would "extend the reach of our established portfolio to a greater number of patients through [Aspen's] extensive commercial network. This agreement supports our strategic focus on the new medicines in three main therapy areas, said Mr Sariot in a statement." AstraZeneca has used externalization income from licensing out products in non-core areas, such as neuroscience, to help fund investment in new medicines in cancer and other fields. Reeling under the pressure of patent expires, AstraZeneca has been selling off rights to the company's older drugs to raise cash and shed extraneous products. The deals reflect an industrywide trend, as major drugmakers zero in on therapeutic fields where they believe they can profit most. Among many other deals, the company recently raised $500 million by selling a partnership to Eli Lilly ($LLY) for an Alzheimer's drug. It snagged $200 million from Daiichi Sankyo, allowing the Japanese drugmaker to develop its treatment for opioid-induced constipation Movantik. Another $215 million was raised by licensing out its gastrointestinal drug Entocort to Tillotts Pharma. ]]> <![CDATA[Sun Pharma focuses on dermatology to boost OTC business]]> https://biospectrumindia.com/news/95/6922/sun-pharma-focuses-on-dermatology-to-boost-otc-business.html https://biospectrumindia.com/news/95/6922/sun-pharma-focuses-on-dermatology-to-boost-otc-business.html Fri, 10 Jun 2016 15:38:43 +0530 As part of its plans to grow the Global Consumer Healthcare business, Sun Pharma will focus on Dermatology as the fourth engine of growth for its OTC business. As part of this growth strategy, the company today announced roll-out of its first dermatology product through the Global Consumer Healthcare business. Branded as Suncros, this is a sunscreen product, offering maximum protection from harmful UV rays till the inner layers of the skin. Currently marketed as a branded prescription product with proven product efficacy has made it the No 1 sunscreen brand to be recommended by dermatologists in the country, Sun Pharma now launched select variants to market directly to consumers. The Suncros range has a highly differentiated product mix that provides an offering for all skin types along with superior benefits of matte finish which ensures non greasy texture, water resistant formulation and 6- 8 hour substantively. Currently, Sun Pharma's Global Consumer Healthcare business in India markets dietary supplements, analgesics and antacids. The business division's entry into dermatology category offers Sun Pharma's OTC business a larger play into fast moving consumer goods category. Sun Pharma entered the Consumer Healthcare / OTC Business as a result of Ranbaxy's merger into Sun Pharma. It is a high margin, high growth business which the company want to use as a base to create a global consumer entity. The company is evaluating various options to grow the business including foray in new products categories and potential inorganic opportunitiesAs part of its business plans to drive Suncros growth in India, the company will co-promote the brand across both prescription & consumer channel. This first-time unique co-promotion strategy will ensure that the brand reaches out to a larger section of new consumers while ensuring its legacy customers are equally serviced. Commenting on dermatology as its new engine of growth Mr Subodh Marwah, Business Head - Global Consumer Healthcare, Sun Pharma said, "Our foray into the dermatology category is an indicator of the focus and importance Sun Pharma assigns to grow the consumer healthcare business. Suncros offers a unique opportunity to foray into the fast growing sunscreen category and once again repeat our success story in the topical analgesics category. With Suncros being marketed directly to consumers, we are now expanding consumer's access to the country's No 1 dermatologist recommended sunscreen brand." Elaborating on the significance of the co-promotion strategy to drive Suncros growth in India, Mr Abhay Gandhi, CEO - India Business, Sun Pharma adds, "Sun Pharma has the largest distribution bandwidth in the prescription business. This will be extensively leveraged to co-promote Suncros brand amongst dermatologists. We believe that our unique first-time co-promoting strategy to market Suncros across both prescription and consumer channels will ensure that the brand continues to receive traction amongst its legacy customers as well as ensure addition of new consumers through the OTC business to drive desired growth for the brand." The company has also signed former Miss India and Bollywood Actress Ms Dia Mirza as Suncros' brand ambassador. Dia's engagement will be supported through an integrated marketing campaign that will aim to reach over a million consumers within the first month of roll-out. The company has also planned an innovative television campaign for Suncros featuring Dia Mirza. Commenting on her association with Suncros brand, Dia Mirza said, "My profession demands that I look flawless at all times, be it in my role of an actress, model, producer or TV show host. I am constantly on the move and for me there is only one rule to keep my skin healthy, I never step outside without a sunscreen irrespective of the weather conditions. Suncros is the perfect shield to my skin from harmful effects of UV rays throughout the year." ]]> <![CDATA[Sanofi launches action 2016, a worldwide employee stock purchase plan]]> https://biospectrumindia.com/news/95/8415/sanofi-launches-action-2016-a-worldwide-employee-stock-purchase-plan.html https://biospectrumindia.com/news/95/8415/sanofi-launches-action-2016-a-worldwide-employee-stock-purchase-plan.html Thu, 09 Jun 2016 14:35:18 +0530 Sanofi announced the launch of Action 2016, a worldwide stock purchase plan reserved for its employees. In doing such a capital increase, Sanofi intends to better associate its employees with the future development and results of the company. The plan will take place in more than 90 countries. On March 3, 2016,¬ the Board of Directors authorized an issuance of ordinary shares of Sanofi for the benefit of employees participating in the Group Savings Plan. The subscription price is â‚¬57.25. It is equal to 80 % of the average of the opening price of the Sanofi share on Euronext Paris over the 20 stock exchange trading sessions preceding June 8, 2016. Any subscription for a minimum of five shares as part of such issuance shall entitle the employee to one matching share. A subscription for ten shares at least or more shall give right to two matching shares as an employer contribution. Employees may choose to subscribe a maximum of 1,500 shares within the limit of a maximum subscription amount which does not exceed 25% of their gross annual remuneration. An eligibility condition of three months of seniority as at the closing date of the subscription period will be applied. The subscription period will run from June 13, 2016 (inclusive) until June 24, 2016 (inclusive). The issuance of new shares and the share delivery process should occur by the end of July 2016. The total number of shares that may be issued under the plan is limited to 6.5 million shares (corresponding to a share capital increase in terms of par value of up to â‚¬13 million, representing 0.5 % of the share capital). The newly issued shares, including the matching shares (the "Shares") will be subscribed (or delivered) either directly or through employee shareholding funds ("FCPE"), depending on the legal and/or tax regulations applicable in the various countries of residence of the beneficiaries of the capital increase. The Shares will be fully fungible with the existing ordinary shares of Sanofi and will be entitled to dividends distributed on benefits relating to the fiscal year starting as of January 1, 2016. The voting rights attached to the Shares subscribed will be directly exercised by the employees. The subscribers to the plan will be required to hold the Shares or the corresponding 'FCPE' units during a period of approximately five years, i.e. until May 31, 2021, except upon the occurrence of an early exit event provided in Article R. 3324-22 of the French Labor Code and authorized in the country of the subscriber. The listing of the Shares on the Euronext Paris market on the same listing line as the existing shares will be requested as soon as possible after the completion of the capital increase. ]]> <![CDATA[Global Type 2 Diabetes market to double to $58.7 bn by 2025]]> https://biospectrumindia.com/features/95/7097/global-type-2-diabetes-market-to-double-to-58-7-bn-by-2025.html https://biospectrumindia.com/features/95/7097/global-type-2-diabetes-market-to-double-to-58-7-bn-by-2025.html Wed, 08 Jun 2016 18:22:38 +0530 The company's latest report states that this growth, which will occur across the nine major markets of the US, France, Germany, Italy, Spain, the UK, Japan, China, and India, will primarily be attributable to a dramatic increase in the diagnosis and prevalence of the disease, and the fact that the rise in type 2 diabetes-related comorbidities has fueled a more aggressive approach in treatment and the use of multiple-drug therapies. Dr Jesus Cuaron, GlobalData's Analyst covering Cardiovascular and Metabolic Disorders, explains: "Increases in disease incidences will result from increased life expectancy and lifestyle changes, such as dietary changes and a reduction in exercise. "Indeed, the US will be impacted the most by such changes, increasing its global market share from 58% to 66% during the forecast period." Due to the increasing prevalence and progressive nature of type 2 diabetes, there are considerably high unmet needs within the indication. Overall, these unmet needs are interrelated and include improved durability of treatment, a better balance of efficacy of glycemic control with cardiovascular safety, hypoglycemia avoidance, and tolerability and ease of compliance. Dr Cuaron continues: "Currently, all available treatments for type 2 diabetes are initially effective and reduce complication rates. The need for drugs which are able to maintain glycemic control in the long term, however, represents a significant growth opportunity for new patent-protected products. "Molecules in the earlier stages of development - Phase II or earlier - employ various novel mechanisms of action. Early-stage novel drug classes include those such as 11-beta-hydroxysteroid dehydrogenase type 1 inhibitors and glucokinase activators" GlobalData believes that in order to address the biggest unmet need in type 2 diabetes, new drugs must address the problem of insulin resistance, as this is the root of the disease. "New products must address insulin resistance while offering a strong safety profile and not causing weight gain," the analyst concludes. ]]> <![CDATA[India's BioEconomy crosses $35 billion : ABLE Report]]> https://biospectrumindia.com/news/95/6945/indias-bioeconomy-crosses-35-billion-able-report.html https://biospectrumindia.com/news/95/6945/indias-bioeconomy-crosses-35-billion-able-report.html Wed, 08 Jun 2016 16:40:32 +0530 India's fast-growing BioEconomy has crossed the $35.1 billion in 2015, according to a Special Report prepared by the Association of Biotechnology-Led Enterprises(ABLE) and released on the inaugural day of the BIO International Conference at Moscone Convention Center in San Francisco on June 7. "This is just an initial estimate and the actual size of the country's BioEconomy could be actually much more," said ABLE Chairperson and CMD of Biocon, Dr Kiran Mazumdar-Shaw, while releasing the Special Report at the India Pavilion at the BIO Convention. The BioEconomy report is part of the Make in India Biotechnology Handbook 2016 brought out by ABLE with support from DBT, BIRAC, CII, KBITS, Bangalore BioInnovation Center, Biocon and Syngene. India has set an ambitious target of achieving a BioEconomy of $ 100 billion by the year 2025. Dr Shaw released the report along with Ms Holly Vineyard, Assistant Secretary of US Department of Commerce, and Mr Nandamuri Ramakrishna, member of Andhra Pradesh Legislative Assembly and Mr Venkatesan Ashok, the Consul General of India-San Francisco. The opening of the India Pavilion and Handbook release was witnessed by more than 150 delegates from India and other countries at the world's largest biotechnology industry event. ABLE team has been working over the past month to put together the data on India's BioEconomy and the Make in India Biotech Handbook 2016. The quick estimates were made from various publicly available and government data on export and import of various products that constitute the key elements of the country's BioEconomy. A more exhaustive report will be prepared in the coming months. Inaugurating the India Pavilion, the ABLE Chairperson Dr Shaw mentioned that this is an exciting time for India's biotechnology sector. She said the Make in India initiative, the new National Policy on Intellectual Property Rights(IPR), the Start Up Initiative that aims to create more than 10,000 startups in technology sectors in the next few years and general increase in confidence levels were key factors driving the growth of India's BioEconomy. The Consul General and Mr Ramakrishna too reiterated these points as the drivers of India's growth economy. Summing up the inaugural function, ABLE President and Evolva India CEO, Dr P M Murali said the Indian delegation has arranged a number of conference sessions to highlight recent developments in regulatory regime related biosimilars, clinical trials, the start up ecosystem and other areas of great interest to global investors looking at India for biotech investments. ]]> <![CDATA[LabCorp announces the availability of the RealStar Zika Virus Test ]]> https://biospectrumindia.com/news/95/8204/labcorp-announces-the-availability-of-the-realstar-zika-virus-test-.html https://biospectrumindia.com/news/95/8204/labcorp-announces-the-availability-of-the-realstar-zika-virus-test-.html Wed, 08 Jun 2016 12:12:17 +0530 Laboratory Corporation of America Holdings (LabCorp) has announced the nationwide availability of testing for Zika virus using the RealStar Zika Virus RT-PCR Kit US from altona Diagnostics GmbH. The test has received Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for the qualitative detection of Zika virus RNA in serum or urine (collected alongside a patient-matched serum specimen). It is intended to be used to aid in the diagnosis of Zika virus infection in individuals meeting clinical and/or epidemiological criteria for infection risk established by the Centers for Disease Control and Prevention (CDC). "The Zika virus is a serious public health threat, and many people are concerned about the risk it presents to them and their families," said Mr David P King, LabCorp's chairman and chief executive officer. "Offering this new Zika virus test aligns with LabCorp's strategy to deliver world-class diagnostics that provide physicians and patients with information they need to achieve better health outcomes." CDC clinical criteria for Zika virus infection testing include signs and symptoms associated with Zika virus infection. CDC epidemiological criteria for Zika virus infection testing include a recent history of residence in or travel to a geographic region with active Zika virus transmission at the time of travel, including for male sexual partners with such residence or travel history. "Public health officials anticipate that the U.S. will become an area of active Zika virus transmission this year," said Dr Marcia Eisenberg, chief scientific officer for LabCorp Diagnostics. "LabCorp is pleased to support the effort to help identify and minimize human transmission of this disease in the US by offering the RealStar Zika Virus RT-PCR Kit US as a new tool that can help to improve health and improve lives." This test has not been FDA cleared or approved. This test has been authorized by FDA under an EUA for use by CLIA High Complexity Laboratories and similarly qualified non-US laboratories and is only authorized for the duration of the declaration that circumstances exist justifying the EUA. It is only authorized for the detection of RNA from Zika Virus and the diagnosis of Zika Virus infection, and not for any other viruses or pathogens. As required by FDA, LabCorp will report positive results of this test to CDC and other public health authorities, as may be appropriate. LabCorp will also report to altona Diagnostics any suspected occurrence of false positive or false negative results of which it becomes aware. ]]> <![CDATA[Surge in biosimilars to drive significant change in health system costs, patient access & competition by 2020]]> https://biospectrumindia.com/features/95/7309/surge-in-biosimilars-to-drive-significant-change-in-health-system-costs-patient-access-competition-by-2020.html https://biospectrumindia.com/features/95/7309/surge-in-biosimilars-to-drive-significant-change-in-health-system-costs-patient-access-competition-by-2020.html Tue, 07 Jun 2016 12:54:33 +0530 Greater acceptance of biosimilar medicines in a growing number of therapy areas and an active pipeline of 56 new products in clinical development are expected to deliver total savings of as much as $110 billion to health systems across Europe and the US through 2020, according to new research by the IMS Institute for Healthcare Informatics. Biosimilars, which compete with original biologic medicines, can provide physicians and patients with greater access to advanced treatments and offer budgetary relief to payers in the face of intensifying healthcare cost pressures. Health systems best positioned to capitalize on the benefits of biosimilars support functioning competitive markets-where manufacturers are motivated to participate over the long term, and where physicians are at the heart of the decision-making process. The IMS Institute report, Delivering on the Potential of Biosimilar Medicines: The Role of Functioning Competitive Markets, found that by 2020, biosimilars will start competing with original biologics that have current sales of $50 billion annually. The extent that these biosimilars provide savings opportunities will depend on policy and implementation approaches that to date have varied across the European Union. As these medicines also become available in the US, stakeholder education and incentives will play a vital role in ensuring biosimilars deliver their full potential. "The prospect of more affordable biologic options that are safe and effective opens up opportunities for health systems to expand access to more patients, and frees up resources for investment in new areas," said Mr Murray Aitken, IMS Health senior vice president and executive director of the IMS Institute for Healthcare Informatics. "This also can yield significant cost savings-but not all markets are ready to fully benefit from the imminent surge of biosimilar molecules." In its latest study, the IMS Institute highlights the following findings: â€¢ Considerable variations across the EU in payer policy approaches are limiting the biosimilar opportunity. Across Europe, payers have adopted a variety of approaches to encourage physicians to prescribe biosimilar medicines, motivate manufacturers to participate in the market, and provide adequate clinical evidence to support the prescribing of these treatments. Not all stakeholders are using competition to maximize in a sustainable way the benefits offered by biosimilars. Germany is among the most successful countries on this front, educating physicians and implementing measures designed to stimulate biosimilar prescribing. By contrast, Austria's approach-where some biosimilar medicines are subject to mandatory price reductions that may force manufacturers out of the market-has had the opposite effect, resulting in reduced access to some biosimilar products. â€¢ Biosimilars use in the EU and U.S. may yield total savings of $56-110 billion over the next five years. By 2020, eight major biologic medicines are expected to lose exclusivity protection, including treatments for auto-immune disorders and diabetes. By opening markets to biosimilar competition, healthcare systems could realize a 30 percent reduction in price per treatment day compared to originator biologics. The extent of actual savings will depend on policy decisions made and actions taken around incentives, education and pricing. â€¢ Patient access to biologic treatments has grown by as much as 100 percent following the availability of biosimilars. In the EU, the use of erythropoietins (EPOs), granulocyte-colony stimulating factors (G-CSFs) and human growth hormone (HGH) have all risen following the launch of biosimilar versions. This increase was heavily driven by the availability of biosimilars, as well as other factors such as expanded indications. In markets where access to these molecules was previously restricted, including Romania, Bulgaria, and the Czech Republic, average uptake of EPOs increased by more than 250 percent following the introduction of biosimilars. The greater use of biologics following the introduction of biosimilars can be attributed to their lower cost, as well as revisions to treatment guidelines that reflect improved cost effectiveness. â€¢ Intensifying competition and greater choice are expected as new biosimilars reach the market. Some 30 companies are actively developing biosimilar medicines for launch and are pursuing biosimilar versions of 16 distinct molecules that will lead to greater competition by 2020. The majority of biosimilars in development are for versions of infliximab, etanercept, rituximab and adalimumab. This robust pipeline represents an opportunity for payers to realize savings, and for physicians and patients to ensure greater access to these important treatments. â€¢ Capturing the benefits of biosimilar medicines requires a balance between controlling price and ensuring a sustainable, competitive marketplace. A narrow focus by payers on price alone risks constraining the longer-term opportunities for savings. This would make the biosimilars market less attractive for manufacturers-reducing incentives to invest in the development of subsequent waves of biosimilars. A balanced approach that incorporates education of physicians, patients and payers, and includes appropriate incentives for physicians and manufacturers, will help ensure that the benefits of biosimilars are fully realized. ]]> <![CDATA[Mylan, Biocon to present Trastuzumab Biosimilar Data at ASCO]]> https://biospectrumindia.com/news/95/6808/mylan-biocon-to-present-trastuzumab-biosimilar-data-at-asco.html https://biospectrumindia.com/news/95/6808/mylan-biocon-to-present-trastuzumab-biosimilar-data-at-asco.html Tue, 07 Jun 2016 11:49:50 +0530 Mylan and Biocon has announced the presentation of data from the HERITAGE study at the 2016 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, June 3-7. The study confirmed the efficacy, safety and immunogenicity of MYL-1401O, the proposed biosimilar trastuzumab co-developed by Biocon and Mylan, in comparison to branded trastuzumab. "As one of the first companies in the industry to successfully complete a confirmatory efficacy and safety study comparing a proposed biosimilar to a branded cancer drug, this is a significant milestone for Mylan's biosimilar program," Mylan President Mr Rajiv Malik said. "There is an urgent, unmet need for more affordable versions of biologic products and through our collaboration with Biocon we are well-positioned to be at the forefront to help deliver these complex products to patients around the world. We're pleased that ASCO has recognized the importance of biosimilars in advancing cancer care and the significant role they will play in providing patients greater access to affordable treatment." Dr Kiran Mazumdar Shaw, Chairperson and Managing Director, Biocon, added, "The positive outcomes of the global Phase 3 clinical study with our proposed biosimilar trastuzumab for HER2-positive breast cancer patients are a significant milestone in our joint biosimilars development program with Mylan. The trial will enable regulatory filings of our product in the developed markets. Biocon remains committed to develop affordable biologics and these study results will help us in enhancing access for cancer patients, caregivers and healthcare systems across the globe." Worldwide, nearly 2 million women are diagnosed with breast cancer each year, making it the second most common cancer in the world. HER2-positive metastatic breast cancer is an aggressive form of breast cancer that tests positive for the human epidermal growth factor receptor 2 (HER2), which promotes cancer cell growth. Approximately 20% to 30% of primary breast cancers are HER2-positive. Trastuzumab is indicated for the treatment of HER2-positive metastatic breast cancer patients. It is also indicated for adjuvant treatment of HER2 overexpressing breast cancer and metastatic gastric cancer. It is a targeted therapy that interferes with the HER2 protein and impedes cancer cell growth. "The HERITAGE study successfully met the predefined endpoints of response equivalency. We are proud of this international collaboration which puts us one step closer to approval of this proposed biosimilar. The response rates at 24 weeks were 69.6% with MYL-1401O combined with taxane chemotherapy versus 64% with branded trastuzumab combined with the same chemotherapy agent. The ratio of overall response and difference in overall response fell within a narrow, pre-defined equivalence margin suggesting equal efficacy of both products. Safety was comparable between treatment groups. The rates of serious adverse events were 38% with MYL-1401O and 36% with branded trastuzumab, and there was no difference in cardiac safety," commented lead study author Dr. Hope S. Rugo, professor of Medicine at the University of California, San Francisco. ]]> <![CDATA[Lupin's new generic gets FDA nod]]> https://biospectrumindia.com/news/95/7408/lupins-new-generic-gets-fda-nod.html https://biospectrumindia.com/news/95/7408/lupins-new-generic-gets-fda-nod.html Tue, 07 Jun 2016 11:49:35 +0530 Pharma Major Lupin announced that its US subsidiary, Gavis Pharmaceuticals LLC., (collectively Lupin) has received final approvals for its Voriconazole Tablets, 50 mg & 200 mg and Voriconazole Oral Suspension, 40 mg/mL from the United States Food and Drug Administration (FDA) to market a generic equivalent of PF Prism C.V's Vfend Tablets, 50 mg & 200 mg and Vfend Oral Suspension, 40 mg/mL. Lupin shall commence promoting the products in the US shortly. Voriconazole Tablets, 50 mg & 200 mg and Voriconazole Oral Suspension, 40 mg/mL are the AB rated generic equivalent of PF Prism C.V's Vfend Tablets, 50 mg & 200 mg and Vfend Oral Suspension, 40 mg/mL. It is indicated for use in patients 12 years of age and older in the treatment of the following fungal infections: â€¢Invasive Aspergillosisâ€¢Candidemia in Non-neutropenic patients and the following Candida infections: Disseminated infections in skin and infections in abdomen, kidney, bladder wall and woundsâ€¢Esophageal Candidiasisâ€¢Serious fungal infections caused by Scedosporium apiospermum (Asexual form of Pseudallescheria boydii) and Fusarium spp. including Fusarium solani in patients intolerant of or refractory to other therapy Vfend Tablets, 50mg & 200mg had US sales of USD 92.8 million (IMS MAT March 2016) while Vfend Oral Suspension, 40 mg/mL had US sales of $15.9 million (IMS MAT March 2016). ]]> <![CDATA[Betting big in India's bioseparation space ]]> https://biospectrumindia.com/interviews/95/8292/betting-big-in-indias-bioseparation-space-.html https://biospectrumindia.com/interviews/95/8292/betting-big-in-indias-bioseparation-space-.html Mon, 06 Jun 2016 12:31:03 +0530 The company's president Mr Anthony J MacDonald, who was formerly with Pall Corporation, recently visited India in setting up and overseeing the company's establishment in Bangalore. Spectrum Labs makes products and services to the Biopharmaceutical and Pharmaceutical industry. It majorly manufactures filtration, purification and separation-related products. He exclusively spoke to BioSpectrum's Raj Gunashekar offering a glimpse into Spectrum's India expansion strategies, further investments, plans on M&As, and the market outlook. The company, a private firm, was founded in 1970, and is headquartered in Los Angeles, California, USA. It has 3 manufacturing sites in the US, along with an engineering site, and 2 logistics sites, totaling up to 6 campuses in the US alone. Spectrum Labs also has a satellite office and a logistics center at Netherlands in Europe, which started in 1999. In 2012, it ventured into China, and the same year extended its European office further. In January 2016, India witnessed the entry of Spectrum Labs into the country in Bangalore city. "Our intention in India is to help customers, and grow with them in the Biotech and Biopharma space. We directly want to service our customers. The type of products we make involve a lot of interactions with them, and we want a crystal clear understanding of their requirements and provide the necessary services," voiced Mr Anthony MacDonald, President, Spectrum Labs. Currently, the bioseparation industry is seeing a major trend, which is, going from the traditional fed-batch fermentation process to perfusion fermentation, a continuous process. Mr MacDonald added that India has multiple growth driving factors for the company. "Firstly, a lot of companies are expanding vaccine manufacturing in a big way here in India. Then there is Biosimilars entering the Indian market in a big way. They are going to be our growth drivers in India," he commented. When asked about the company's strategies in handling competition from small and medium enterprises (SMEs), Mr MacDonald shared, "We make our separation technology in a competitive manner, which is best in the US and Europe. We compete well with the SMEs and take on the challenge. When we bump into them, we always see what their advantages are and play on those. We ensure customers see the value of our products and services." He feels that running a business in India will bring in its own unique challenges. "We are getting familiar on how to do the business in India. There are a lot of regulatory challenges. We have an experienced director here in India who is now guiding us. Indian market is different from other markets. When we opened our China office in 2012, it was quite a learning curve. We use that as a blueprint in conducting business in India. We apply that concept and work with the local consulting group. People say Chinese market is hard. Yes, it is! But India has more pages of regulations to work with. Indian market is not necessarily difficult but you just need to know how to, and be familiar with the market," he explained. The company's President also revealed that Spectrum Labs will expand further within India in a stronger way. He opined, "We are profit-driven. We want to get to a profitable stage in India. Once we are there and can maintain a good sustainability, we are going to add other sites in India. But for now, first we want to build the business in Bangalore. Once we are up and running here, we will invest in other sites. We are working on that right now. Our next destination could be metros like Chennai, Hyderabad, or Mumbai." Spectrum's R&D happens predominantly in the US. It invests a significant 2% to 5% of its revenues into its R&D annually. "As we expand further, our R&D will happen at various centers. Our technology is evolutionary, and we are working along with our customers. Our R&D product development comes from the field, and from our technology sales force, and also from the in-house engineering teams," Mr MacDonald expressed. Most of the company's revenues is generated from the US markets. He highlighted, "But the revenue percentage will decline as we grow further. For example, 12 years ago, our revenues from North America was 80%. Today, it is down to 60%. The rest of the world contributes 40%. "Right now our Asian revenue stands at 15%. But, in the next few years, Asia will represent over 30%. "We also believe that our distribution revenues will be 40% in the US, and 60% from the rest of the world. In the next 5 years or so, out of this 60%, Asia and Europe will contribute to 30% each." The company has a plethora of reasons in choosing Bangalore as an entry point to the Indian market. "Bangalore is the home to the IT industry. As we grow and invest in business, IT is going to play a bigger part in it. Companies who are competing with us are also based in Bangalore. It's a home to our type of industry, and the weather is simply perfect," Mr MacDonald justified. As of now, the company is very bullish about the Indian market. "We invest a lot of time and money in membrane technology and its applications. We are looking forward to work with Indian customers in the Biotech, Biopharmaceutical and Pharmaceutical industries to help them grow. Our market is the separations industry, which is a multi-billion dollar market. We are a segment of the separations industry, and the Indian market is a subset of that. The market will grow with the Biopharmaceutical space. It is in fact going to hit a solid double-digit in India," he held. Will the company take M&A route in India? "Yes," Mr MacDonald stated. "We are open to M&As. We cannot share anything about it at the moment. But we do have plans for M&As in India." ]]> <![CDATA[Sanofi India elects new Chairman ]]> https://biospectrumindia.com/news/95/7369/sanofi-india-elects-new-chairman-.html https://biospectrumindia.com/news/95/7369/sanofi-india-elects-new-chairman-.html Mon, 06 Jun 2016 12:30:40 +0530 Sanofi India Limited (SIL) announced the election of Mr Aditya Narayan as the Chairman of the Board of Directors. "Sanofi India Limited is privileged to have Mr. Aditya Narayan as Chairman of the Board of Directors", said Dr Shailesh Ayyangar, Managing Director - Sanofi India Limited. "For over 60 years, Sanofi India has played the role of a committed and responsible company by making world-class medicines accessible in India, and meeting the challenges of our nation's growing disease burden. Sanofi India welcomes Mr. Narayan, with his commendable track record as a corporate leader, to guide it through the emerging complexities in the Indian pharmaceutical environment." Commenting on his new role, Mr Aditya Narayan, Chairman, Sanofi India Limited, said, "Sanofi India Limited has a superb track record of building strong pharmaceutical brands, several of which are now household names. Its world class manufacturing facilities and ethical marketing practices enjoy a reputation for excellence in serving its growing customers in India and overseas. It is a privilege for me to have been entrusted with the role of the Chairman of the Board of Directors of Sanofi India Limited and I look forward to the support of all its stakeholders in discharging my responsibilities." Mr Aditya Narayan, 64, has rich experience in industry for over 40 years. He served ICI Limited, now Akzo Nobel India Limited, for about 30 years across diverse functions and businesses. He was its Managing Director during 1996-2003 and then its non-executive Chairman over 2003 - 2010. Over 2005-2009, he was the President and CEO of BHP Billiton India. He has also served on a number of other Boards. Presently, he is an Independent Director of Hindustan Unilever Limited, Linde India Limited and, Chambal Fertilizers and Chemicals Limited. ]]> <![CDATA['Smart Water' emerges winner]]> https://biospectrumindia.com/news/95/8185/smart-water-emerges-winner.html https://biospectrumindia.com/news/95/8185/smart-water-emerges-winner.html Wed, 01 Jun 2016 18:02:08 +0530 The prototype called Smart Water, bagged the top prize at the first-ever 'iDeate - The Great Digital India Challenge' organized by Cisco in Bengaluru. The feat was achieved in the face of stiff competition from 40 other Indian universities, including IITs and IIITs. The winning team, which got a cash prize of Rs 2.5 lakhs, included Mr Akshay Balachandran, Mr Surya Murugaian, Mr Parthasarathy R, and Mr Murali Siva, all third-year students of Amrita School of Engineering at Amrita University. Teams from IIT Kharagpur and IIIT Bangalore bagged the 2nd and 3rd prize, respectively. Large water bodies like lakes, ponds and dams are regularly monitored worldwide and their water quality analyzed to keep a tab on water exploitation and pollution. Existing manual-sampling techniques consume a significant amount of time and resources, and are prone to inaccuracies in data collection. To rectify these defects of the traditional sampling method, remote sensing technology was introduced, but the accuracy of data obtained is completely dependent on the number of nodes installed. In recent years, advancements in data analysis, machine learning, Internet of Things (IoT) and autonomous boats have made it possible for water quality to be monitored without implementing the sensor nodes. Explained Dr Sasangan Ramanathan, Dean, Amrita School of Engineering, Amrita University: "Our students have proposed a novel technique to collect various parameters of water such as the pH level, dissolved oxygen, temperature, and conductivity only from a limited number of locations across a water body. "The data collected from these is used to generate a hypothesis function through machine learning that can accurately predict the parameter values at all other locations. Our students have also framed a technique that can predict the quality state of a water body a month or even a year in advance, so that necessary measures can be taken pre-emptively to save them from over-exploitation. This novel technique to measure and predict the quality of water is the first of its kind in the world." The prototype was successfully tested by students across water bodies of all sizes, from swimming pools to lakes. Added Dr Sasangan Ramanathan: "The students' Smart Water project is on its way to becoming a start-up. We have received interest from many companies such as Cisco for taking the prototype forward towards commercialization. The Amrita Technology Business Incubator (TBI) is also in talks with our department. "A decision about launching the start-up will be taken soon. Hopefully, in a few years, this technology developed by Amrita students will be adopted worldwide and make a real difference in saving fresh water bodies from over-exploitation. I congratulate our students and faculty for such a stupendous feat." Said Mr Surya Murugaian, the student who was the leader of the team: "As budding engineers, we wanted to invent something for a more sustainability world. So we formed a team called Circuit Breakers and started working day and night for more than a year to come up with Smart Water." Cisco's event was focused on Internet of Things (IoT) based ideation challenge for India. Hundreds of students from 40 of India's top universities took part. Eight teams were chosen as semi-finalists, out of which three were declared the winners. The teams worked with Cisco mentors to build working prototypes of their ideas. ]]> <![CDATA[Strides receives USFDA tentative approval for Roflumilast ]]> https://biospectrumindia.com/news/95/7066/strides-receives-usfda-tentative-approval-for-roflumilast-.html https://biospectrumindia.com/news/95/7066/strides-receives-usfda-tentative-approval-for-roflumilast-.html Wed, 01 Jun 2016 18:01:41 +0530 Roflumilast is used to prevent worsening of symptoms in people with severe chronic obstructive pulmonary disease (COPD). The product received approval in 15 months under the new GDUFA goal date regime. The product will be launched earliest by January 2020. According to IMS data, the US market for Roflumilast Tablets 500 mcg is approximately $174 million. Roflumilast tablets registered a healthy growth of 16% in value terms and 5% in volume terms in US (IMS March 2016 MAT data). Based upon available information, company believes it is amongst the first wave of ANDA applicants for Roflumilast with a Paragraph IV certification, which is under litigation as per the provisions of the Hatch-Waxman Act. On receiving full approval, the product will be manufactured at the company's Oral dosage facility at Bangalore and marketed by Strides Shasun in the US market. ]]> <![CDATA[Dr Reddy's launches plaque psoriasis drug]]> https://biospectrumindia.com/news/95/7019/dr-reddys-launches-plaque-psoriasis-drug.html https://biospectrumindia.com/news/95/7019/dr-reddys-launches-plaque-psoriasis-drug.html Wed, 01 Jun 2016 15:07:01 +0530 Dr Reddy's Laboratories has announced that its US subsidiary, Promius Pharma, Sernivo (betamethasone dipropionate) Spray, 0.05% in the U.S. Sernivo Spray, a prescription topical steroid approved by the Food and Drug Administration (FDA) in February of 2016, is indicated for the treatment of mild to moderate plaque psoriasis in patients 18 years of age or older. "We are proud to bring Sernivo Spray to patients across the U.S.," said Mr Raghav Chari, Executive Vice President, Proprietary Products Group at Dr Reddy's Laboratories, "This is another significant milestone for Promius Pharma. As an emerging leader in the dermatology space, we are committed to developing innovative treatment options." Promius has conducted two multi-center, randomized, double-blind, vehicle-controlled clinical trials in subjects aged 18 years and older with moderate plaque psoriasis to evaluate the safety and efficacy of Sernivo Spray. In both trials, randomized subjects applied Sernivo Spray or vehicle spray to the affected areas twice daily for 28 days. Enrolled subjects had body surface area of involvement between 10% to 20% and an Investigator Global Assessment (IGA) score of 3 (moderate). Efficacy was assessed as the proportion of subjects who were considered a treatment success (defined as having an IGA score of 0 or 1 [clear or almost clear] and at least a 2-scale reduction from baseline). Treatment success was achieved in significantly more subjects using Sernivo Spray than vehicle at both Day 15 and Day 29 across both studies. At Day 29 in Studies 1 and 2, Sernivo Spray achieved treatment success of 42.7% and 34.5% compared to vehicle success rates of 11.7% and 13.6%, respectively (p < 0.001). "Plaque psoriasis can be a frustrating condition for patients and physicians alike. For patients, it is not only itchy and painful, but depending on where on the body it occurs, it can be embarrassing for them and decrease their quality of life," said Dr Leon H. Kircik, clinical associate professor of dermatology at Indiana University School of Medicine. "As one of the researchers for Sernivo Spray, I'm excited to see this new treatment option added to our tool chest. With Sernivo Spray, I will now have a versatile option for patients that is easy to use in difficult to treat areas, like elbows and knees." ]]> <![CDATA[Perrigo launches nasal spray 'Flonase']]> https://biospectrumindia.com/news/95/7016/perrigo-launches-nasal-spray-flonase.html https://biospectrumindia.com/news/95/7016/perrigo-launches-nasal-spray-flonase.html Wed, 01 Jun 2016 15:06:47 +0530 Perrigo and its partner West-Ward Pharmaceuticals Corp. has announced the US Food and Drug Administration has approved, and that Perrigo has launched, fluticasone propionate nasal spray USP, 50 mcg per spray, the store brand equivalent to Flonase. This product is packaged and marketed as store brand or retailer 'own label' brands and provides consumers with a high-quality, value alternative to Flonase. Flonase (fluticasone propionate nasal spray USP, 50 mcg per spray) is indicated for the temporary relief of hay fever or other upper respiratory allergies in adult and pediatric patients 4 years of age and older. Combined store brand and national brand sales for the twelve months ending May 2016 were $343 million. Perrigo's CEO Mr John T. Hendrickson stated, "This product approval and launch demonstrates the power of Perrigo's OTC platform. Our team has made significant efforts to bring this important product to our customers and consumers in the U.S. Important product launches like the store brand switch of fluticasone are what drive the Perrigo advantage by providing our consumers with high quality, value alternatives in important treatment categories." ]]> <![CDATA[DCGI gives limited approval to market first allogeneic cell therapy product in India]]> https://biospectrumindia.com/news/95/8425/dcgi-gives-limited-approval-to-market-first-allogeneic-cell-therapy-product-in-india.html https://biospectrumindia.com/news/95/8425/dcgi-gives-limited-approval-to-market-first-allogeneic-cell-therapy-product-in-india.html Tue, 31 May 2016 18:02:38 +0530 Stempeutics Research, a group company of Manipal Education & Medical Group and a Joint Venture with Cipla Group, announced that the Drugs Controller General (India) has granted limited approval for manufacturing & marketing of stem cell based biological product Stempeucel for the treatment of Buerger's Disease. Buerger's Disease is a rare and severe disease affecting the blood vessels of the legs. It is characterized by inflammation and occlusion of the vessels of extremities resulting in reduced blood flow to these areas, thus leading to severe pain and ulcers or necrosis, which finally may require amputation. Stempeucel treatment is designed to enhance the body's limited capability to restore blood flow in ischemic tissue by reducing inflammation and improving neovascularization. Commenting on the approval of DCGI, Mr B N Manohar, CEO of Stempeutics said, "Obtaining DCGI approval for Stempeucel is an important and historic milestone for Stempeutics. We are the first company in India to achieve such approval. It took almost 9 years to develop Stempeucel for the treatment of Buerger's Disease. European Medicinal Agency has classified Stempeucel as an Advanced Therapeutic Medicinal Product (ATMP) and designated it as an Orphan Drug (ODD) for the treatment of Buerger's Disease. Our goal is to globalize Stempeucel for Buerger's Disease and the market size is approximately $ 1.5 billion worldwide". Mr Chandru Chawla, Head Cipla New Ventures said, "Today is not only a great day for Stempeutics, but for everyone involved in the responsible development of stem cell therapies. Through Cipla Group's investment in Stempeutics, we have brought the next generation of biologics to address unmet medical needs. Physicians now have an off-the-shelf stem cell therapy in their hand to fight Buerger's Disease. Much like the introduction of antibiotics in the late 1920's, with stem cells we have now officially taken the first step into this new paradigm of medicine." ]]> <![CDATA[India, Oz sign agreement to boost Horticulture research]]> https://biospectrumindia.com/news/95/7202/india-oz-sign-agreement-to-boost-horticulture-research.html https://biospectrumindia.com/news/95/7202/india-oz-sign-agreement-to-boost-horticulture-research.html Mon, 30 May 2016 17:57:55 +0530 Biotechnology Industry Research Assistance Council (BIRAC), a Public Sector Enterprise of Government of India, signed a Memorandum of Understanding (MoU) with Horticulture Innovation Australia (Hort Innovation) for launching a joint funding call to support Research and Development (R&D) organizations and other eligible entities to undertake novel and cutting-edge strategic translational research in horticulture at affordable costs. The event took place at the Australian High Commission in New Delhi and was presided over by H E Ms Harinder Sidhu, Australian High Commissioner to India, and Prof K VijayRaghavan, Secretary, Department of Biotechnology (DBT), Government of India. As stated by Prof VijayRaghavan, Secretary, DBT & Chairman, BIRAC. "BIRAC's vision is to stimulate and enhance the strategic research and innovation capabilities of the Indian biotech industry, particularly start-ups and SME's, for the creation of affordable products addressing the needs of the largest section of society. Considering the gap between demand and supply for crops, it is of paramount importance to stimulate an enabling environment for research and development in both the regions. Through the signing of this MoU today, we along with Hort Innovation aim to create a supportive 'innovation ecosystem' for researchers to undertake high-level research and promote horticulture techniques." The focus of the joint call is to undertake horticultural research in order to develop and deploy modern tools of plant biotechnology to improve crop productivity. The funding commitment from BIRAC and Hort Innovation is up to AUD 6 million over a period of 3 years. "Encouraging and fostering research and development of innovative interventions and practices that ensure sustenance can go a long way in improving livelihoods and the quality of life. We, at Hort Innovation have made it our mission to increase the productivity, farm gate profitability and global competitiveness of Australia's horticulture industries and now through this partnership want to extend the same knowledge and support to horticulture industries in India to improve their productivity and competitiveness. India has been a centre of innovation and research as far as horticultural practices are concerned and we are pleased that our collaboration with BIRAC will allow for the exchange of skills, knowledge and information between horticulturalists of both the regions," said Mr David Moore, General Manager of Research Marketing and Investment, Hort Innovation. The MoU was signed by Dr Renu Swarup, Senior Adviser, DBT & Managing Director, BIRAC and David Moore, on behalf of their respective organizations. The event was attended by participants from both the Indian and the Australian delegation. "India has encouraged projects relating to the establishment of commercial production units in open field as well as under protected conditions and projects on Post harvest Management and primary processing of products. In Hort Innovation, we have found the perfect ally to conduct cutting-edge research in the area of Horticulture. This strategic partnership will undoubtedly promote the development of cost effective practices for crop harvesting. Creativity and innovative practices in an agrarian economy like India will have far reaching impact on its socio-economic progress," said Dr Renu Swarup. ]]> <![CDATA[Strides receives USFDA approval for Metronidazole ]]> https://biospectrumindia.com/news/95/7324/strides-receives-usfda-approval-for-metronidazole-.html https://biospectrumindia.com/news/95/7324/strides-receives-usfda-approval-for-metronidazole-.html Mon, 30 May 2016 17:24:39 +0530 Strides Shasun announced that it has received approval from the United States Food & Drug Administration (USFDA) for Metronidazole Tablets USP, 250 mg and 500 mg. The product received approval in 17 months under the new GDUFA (Generic Drug User Fee Amendments) regime. It is ready for immediate launch, said the company's press release. According to IMS data, the US market for Metronidazole Tablets USP, 250 mg and 500 mg is approximately $50 million. The product will be manufactured at the company's oral dosage facility at Bangalore, and marketed by Strides in the US market. ]]> <![CDATA[Adopt plain packaging to halt tobacco epidemic: WHO]]> https://biospectrumindia.com/news/95/8267/adopt-plain-packaging-to-halt-tobacco-epidemic-who.html https://biospectrumindia.com/news/95/8267/adopt-plain-packaging-to-halt-tobacco-epidemic-who.html Mon, 30 May 2016 17:24:21 +0530 The World No Tobacco Day is observed on May 31st every year. Tobacco use continues to be a major public health issue across the WHO South-East Asia Region with nearly 246 million people in the Region's 11 countries continuing to smoke tobacco and just below 290 million using it in smokeless forms. WHO's South-East Asia Region comprises the following 11 Member States: Bangladesh, Bhutan, Democratic People's Republic of Korea, India, Indonesia, Maldives, Myanmar, Nepal, Sri Lanka, Thailand and Timor-Leste. "The message isn't getting through: Tobacco kills. A good way to amplify it and disrupt the psychology of tobacco consumption is making the plain packaging of tobacco products - also known as standardized packaging - mandatory. Plain packaging means branding and promotional information is removed from tobacco packaging and replaced by graphic health warnings, dull color combinations, a brand name and a product and/or manufacturer's name in standardized font. The aesthetic impact of plain packaging is significant, with studies showing that it has tangible effect on the desirability of tobacco products," said Dr Poonam K Singh, WHO Regional Director for South-East Asia. As smoking levels decline in high-income countries tobacco companies are increasingly relying on market presence in developing economies, including those of the South-East Asia Region. "This presence must be resisted. Tobacco's impact goes beyond public health, stymieing the growth prospects of developing economies and burdening taxpayers and health systems whose finite resources could be better used elsewhere," she added. Though all 11 member countries, including Parties to the WHO Framework Convention on Tobacco Control, have developed and implemented tobacco control legislation, children, youth and adults continue to be subjected to pro-tobacco messages in media and also encounter product advertising at outlets where tobacco is sold. "Commitment to stopping the tobacco epidemic must be renewed," Dr Poonam insisted. "The Seventh Session of the Conference of Parties to the Framework Convention, due to be held by India in November, provides the opportunity to do just that. It also provides an opportunity to emphasize the importance of plain packaging and open discussions on its uptake in the Region. Plain packaging is one of the easiest ways to help our friends and family live longer and healthier lives and is an initiative that will only gain momentum." ]]> <![CDATA[New Vasculitis drug to address unmet needs]]> https://biospectrumindia.com/features/95/8378/new-vasculitis-drug-to-address-unmet-needs.html https://biospectrumindia.com/features/95/8378/new-vasculitis-drug-to-address-unmet-needs.html Fri, 27 May 2016 16:25:22 +0530 ChemoCentryx's CCX168, an orally administered small molecule in development for the treatment of patients with anti-neutrophil cytoplasmic antibody-associated vasculitis (AAV), has strong potential to address major unmet needs in the vasculitis space, according to an analyst with research and consulting firm GlobalData. Ms Alexandra Annis, GlobalData's Analyst covering Immunology, states: "The majority of those currently diagnosed with AVV achieve remission, but a substantial risk of relapse means that they face a prolonged duration of maintenance therapy, resulting in long-term exposure to therapies with significant side effects. Long exposure to Rituxan or methotrexate, for example, is associated with significant side effects and must be administered in conjunction with glucocorticoids (GC)." As explored in GlobalData's vasculitis report, there are a vast number of unmet needs in the treatment space, and new drugs are needed to reduce the overall treatment burden of current therapy options. Ms Annis explains: "CCX168, which was recently awarded an Orphan Products Development grant by the FDA, could address this, and has demonstrated an impressive safety and efficacy profile in the Phase II European CLEAR study, designed to assess whether it could replace the use of high-dose, chronic GCs without compromising efficacy. "In terms of the potential competition CCX168 may face in the AAV market, GlobalData expects that the drug will hold an advantage over several competitors due to attractive pricing. "For example, Bristol-Myers Squibb's Orencia (abatacept) and GlaxoSmithKline's Benlysta (belimumab) may be able to completely replace GCs, and are expected to hit the market before CCX168, which is not expected to launch until after 2024. However, Orencia and Benlysta are expected to be priced at around $40,000 and $50,000 per patient per year, respectively, meaning CCX168 may hold the upper hand given its anticipated lower price point as a small molecule." ]]> <![CDATA[Strides receives tentative approval for Efavirenz ]]> https://biospectrumindia.com/news/95/8355/strides-receives-tentative-approval-for-efavirenz-.html https://biospectrumindia.com/news/95/8355/strides-receives-tentative-approval-for-efavirenz-.html Fri, 27 May 2016 16:24:08 +0530 Efavirenz is indicated for the treatment of Human Immunodeficiency Virus Type 1 (HIV-1) infected adults and adolescents. The final approval will be received after Patent Expiry in August 2018. According to IMS data, the US market for Efavirenz 600 mg Tablet is approximately USD $150 million. The product will be manufactured at the company's oral dosage facility in Bangalore, and marketed by Strides in the US market. ]]> <![CDATA[FDA Panel recommends Sanofi's diabetes drug ]]> https://biospectrumindia.com/news/95/8217/fda-panel-recommends-sanofis-diabetes-drug-.html https://biospectrumindia.com/news/95/8217/fda-panel-recommends-sanofis-diabetes-drug-.html Fri, 27 May 2016 11:53:17 +0530 Sanofi has announced that the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) of the US Food and Drug Administration (FDA) recommended the approval of the New Drug Application (NDA) for the investigational fixed-ratio combination of basal insulin glargine 100 Units/mL and GLP-1 receptor agonist lixisenatide for the treatment of adults with type 2 diabetes. The 15-member panel voted 12 to 2 (1 panelist did not vote due to travel) to approve the fixed-ratio combination of basal insulin glargine 100 Units/mL and GLP-1 receptor agonist lixisenatide. "We are pleased by the Advisory Committee's recommendation for approval of this investigational diabetes therapy," said Dr Elias Zerhouni, president, Global R&D, Sanofi. "By combining the complementary therapeutic effects of insulin glargine on fasting plasma glucose and of lixisenatide on postprandial plasma glucose, both of which can contribute to HbA1c lowering, this fixed-ratio product may address some of the unmet needs of adults living with type 2 diabetes who are considering initiating or intensifying insulin. We look forward to continuing to work with the FDA as it completes its reviews of these New Drug Applications." The NDA submission for the fixed-ratio combination of basal insulin glargine 100 Units/mL and GLP-1 receptor agonist lixisenatide is based on data from two Phase 3 studies, which enrolled more than 1,900 adults worldwide to evaluate the efficacy and safety of the fixed-ratio combination of basal insulin glargine 100 Units/mL and GLP-1 receptor agonist lixisenatide when used in patient populations insufficiently controlled after oral antidiabetic agents (OADs) and after basal insulin therapy, respectively. Both studies met their primary endpoints. The full results of both studies will be presented in June 2016 at the American Diabetes Association's 76th Scientific Sessions. The NDA submission for lixisenatide is based on results from the GetGoal clinical program, which included 13 clinical trials involving more than 5,000 adults with type 2 diabetes. The NDA submission for lixisenatide also includes findings from the ELIXA study, a long-term cardiovascular (CV) outcomes study in adults with type 2 diabetes and high CV risk (i.e., patients who have recently experienced a spontaneous acute coronary syndrome event). Lixisenatide and the fixed-ratio combination of basal insulin glargine 100 Units/mL and GLP-1 receptor agonist lixisenatide are undergoing FDA review, with decisions anticipated in July and August 2016, respectively. The proprietary names for both compounds in the U.S. are under consideration. Lixisenatide is currently approved in more than 60 countries worldwide under the proprietary name Lyxumia. The fixed-ratio combination of basal insulin glargine 100 Units/mL and GLP-1 receptor agonist lixisenatide was submitted for regulatory review in the European Union in March 2016 and has not yet been approved for use by any health authority. ]]> <![CDATA[Biocon to set up a new manufacturing facility]]> https://biospectrumindia.com/news/95/7725/biocon-to-set-up-a-new-manufacturing-facility.html https://biospectrumindia.com/news/95/7725/biocon-to-set-up-a-new-manufacturing-facility.html Fri, 27 May 2016 11:52:00 +0530 The Karnataka State government has cleared biotechnology major Biocon's Rs. 1,060-crore investment proposal for setting up a new pharmaceutical plant on the outskirts of Bangalore. The new unit, that will come up on leased plots at the new KIADB Industrial Area in Jigani, few kilometers from the Biocon Park in Bangalore, will produce injectables, monoclonal antibodies and oral solid dosage. The facility is expected to generate at least 750 jobs immediately. Biocon's investment proposal was approved by the State High Level Clearance Committee (SHLCC) chaired by Karnataka Chief Minister, Mr Siddaramaiah at a meeting on May 25, 2016. ]]> <![CDATA[Zydus gets FDA nod for anti-fungal drug ]]> https://biospectrumindia.com/news/95/5609/zydus-gets-fda-nod-for-anti-fungal-drug-.html https://biospectrumindia.com/news/95/5609/zydus-gets-fda-nod-for-anti-fungal-drug-.html Thu, 26 May 2016 11:36:00 +0530 Zydus Cadila has received the final approval from the USFDA to market Voriconazole Tablets in strengths of 50 mg and 200 mg. The drug will be produced at the group's formulations manufacturing facility at Baddi. The estimated sales for Voriconazole Tablets which is used in the treatment of fungal infections, is $92.8 million, as per IMS (MAT March 2016). The group now has more than 100 approvals and has so far filed nearly 270 ANDAs since the commencement of the filing process in FY 2003-04. ]]> <![CDATA[Dr Reddy's acquires six OTC brands ]]> https://biospectrumindia.com/news/95/3648/dr-reddys-acquires-six-otc-brands-.html https://biospectrumindia.com/news/95/3648/dr-reddys-acquires-six-otc-brands-.html Wed, 25 May 2016 16:16:53 +0530 Dr Reddy's Laboratories has announced the acquisition of an eminent portfolio of over-the-counter (OTC) brands in the cough-and-cold, pain, and dermatology categories. The company acquired six OTC brands from Ducere Pharma, including DOAN'S, BUFFERIN, NUPERCAINAL Ointment, CRUEX Nail Gel, COMTREX, and MYOFLEX. "These legacy products enjoy strong brand equity built over several decades," explains Mr Alok Sonig, executive vice president and head of Dr Reddy's in the US. "We are extremely excited to be entering the branded consumer health arena through these brands and embarking upon the next avenue of growth for our OTC business in the US." According to Sonig, Dr Reddy's will build upon the sales and marketing efforts for these brands and continue to focus on their expansion into existing and new market channels. Sonig commends the marketing and brand-building efforts of Ducere Pharma, recognizing the organization's role in successfully revitalizing the brands through improved distribution and promotional efforts. "We think Dr Reddy's is well-positioned to continue the successful growth of these brands," says Mr Samuel F Hines of Casla Capital Management LLC. "We feel confident that our brand-loyal consumers will be well-served by the deal." ]]> <![CDATA[Bayer offers to acquire Monsanto for $62 bn]]> https://biospectrumindia.com/news/95/8301/bayer-offers-to-acquire-monsanto-for-62-bn.html https://biospectrumindia.com/news/95/8301/bayer-offers-to-acquire-monsanto-for-62-bn.html Mon, 23 May 2016 17:25:44 +0530 In response to further market speculation and stakeholder inquiries, Bayer is publicly disclosing the contents of its private proposal to acquire Monsanto. Bayer has made an all-cash offer to acquire all of the issued and outstanding shares of common stock of Monsanto Company for $122 per share or an aggregate value of $62 billion. This offer, based on Bayer's written proposal to Monsanto dated May 10, 2016, represents a substantial premium of: - 37 percent over Monsanto's closing share price of $89.03 on May 9, 2016 - 36 percent over the three-month volume weighted average share price- 33 percent over the six-month volume weighted average share price - Last twelve months EBITDA multiple of 15.8x as of February 29, 2016 The acquisition of Monsanto would be a compelling opportunity to create a global agriculture leader, while reinforcing Bayer as a Life Science company with a deepened position in a long-term growth industry. The combination is expected to provide Bayer's shareholders with accretion to core EPS by a mid-single-digit percentage in the first full year after closing and a double-digit percentage thereafter. Initially, Bayer expects annual earnings contributions from total synergies of approximately $1.5 billion after year three plus additional integrated offer benefits in future years. "We have long respected Monsanto's business and share their vision to create an integrated business that we believe is capable of generating substantial value for both companies' shareholders," said Werner Baumann, CEO of Bayer AG. "Together we would draw on the collective expertise of both companies to build a leading agriculture player with exceptional innovation capabilities to the benefit of farmers, consumers, our employees and the communities in which we operate." This transaction would bring together leading Seeds & Traits, Crop Protection, Biologics, and Digital Farming platforms. Specifically, the combined business would benefit from Monsanto's leadership in Seeds & Traits and Bayer's broad Crop Protection product line across a comprehensive range of indications and crops. The combination would also be truly complementary from a geographic perspective, significantly expanding Bayer's long-standing presence in the Americas and its position in Europe and Asia/Pacific. Customers of both companies would benefit from the broad product portfolio and the deep R&D pipeline. "Bayer is committed to enabling farmers to sustainably produce enough healthy, safe and affordable food capable of feeding the world's growing population," said Liam Condon, member of the Board of Management of Bayer AG and head of the Crop Science Division. "Faced with the complex challenge of operating in a resource-constrained world with increasing climate volatility, there is a clear need for more innovative solutions that advance the next generation of farming. By supporting farmers of all sizes on every continent, the combined business would be positioned as the partner of choice for truly integrated, superior solutions." Under the proposed transaction, the combined business would provide attractive opportunities for the employees of both companies and have its global Seeds & Traits and North American commercial headquarters in St. Louis, Missouri, its global Crop Protection and divisional Crop Science headquarters in Monheim, Germany, and an important presence in Durham, North Carolina, as well as many other locations throughout the U.S. and around the world. Digital Farming for the combined business would be based near San Francisco, California. Bayer is highly confident in its ability to finance the transaction based on advanced discussions with and support from its financing banks, BofA Merrill Lynch and Credit Suisse. The offer is not subject to a financing condition. Bayer intends to finance the transaction with a combination of debt and equity. The expected equity portion represents approximately 25 percent of the transaction's enterprise value and is expected to be raised primarily via a rights offering. The strong cash flow generation of the combined business as well as Bayer's track record of disciplined deleveraging after large acquisitions would enable rapid deleveraging post-acquisition. This is in line with Bayer's target of an investment-grade rating immediately after closing of the transaction and its commitment to the single "A" credit rating category in the long term. Bayer has a successful track record of working with global authorities to secure the necessary regulatory approvals and has extensive experience integrating acquisitions from a business, geographic, and cultural perspective. Bayer's Board of Management and Supervisory Board unanimously approved the proposal and are fully committed to pursuing the transaction. Bayer is prepared to proceed immediately to due diligence and negotiations and to quickly agree to a transaction. The transaction will be subject to customary closing conditions. BofA Merrill Lynch and Credit Suisse are acting as lead financial advisors to Bayer and support the financing of the transaction; Rothschild has been retained as an additional financial advisor to Bayer. Bayer's legal advisors are Sullivan & Cromwell LLP (M&A) and Allen & Overy LLP (Financing). ]]> <![CDATA[Suven secures four product patents]]> https://biospectrumindia.com/news/95/7842/suven-secures-four-product-patents.html https://biospectrumindia.com/news/95/7842/suven-secures-four-product-patents.html Mon, 23 May 2016 16:29:28 +0530 Suven Life Sciences Ltd (Suven) announced that they secured product patents in Australia ( 2012388383), Eurasia (22746), Israel (228019) and USA (9328092) to their New Chemical Entities (NCE's) for CNS therapy through mechanism of action - H3 Inverse agonist and these patents are valid until 2032, 2030, 2031 and 2032 respectively. The granted claims of the patent include the class of selective H3 ligands discovered by Suven and are being developed as therapeutic agents and are useful in the treatment of cognitive impairment associated with neurodegenerative disorders. With these new patents, Suven has a total of twenty four (24) granted patents from Australia, Seventeen (17) granted patents from Eurasia, Nine (9) granted patents from Israel and twenty four (24) granted patents from USA. These granted patents are exclusive intellectual property of Suven and are achieved through the internal discovery research efforts. Products out of these inventions may be out-licensed at various phases of clinical development like at Phase-I or Phase-II. "We are very pleased by the grant of these patents to Suven for our pipeline of molecules in CNS arena that are being developed for cognitive disorders with high unmet medical need with huge market potential globally" says Mr Venkat Jasti, CEO of Suven. Suven Life Science is a biopharmaceutical company focused on discovering, developing and commercializing novel pharmaceutical products, which are first in class or best in class CNS therapies through the use of GPCR targets. Suven has 3 clinical stage compounds, a Phase 2 undergoing candidate SUVN-502, Phase 1 completed candidate SUVN-G3031 and Phase 1 undergoing candidate SUVN-D4010 for Alzheimer's disease and Schizophrenia. In addition to that the Company has ten (10) internally-discovered therapeutic drug candidates currently in pre-clinical stage of development targeting conditions such as ADHD, dementia, depression, Huntington's disease, Parkinson's disease and pain. ]]> <![CDATA[Hot Start-ups: A saga of the world's fastest DNA, RNA stain ]]> https://biospectrumindia.com/features/95/8336/hot-start-ups-a-saga-of-the-worlds-fastest-dna-rna-stain-.html https://biospectrumindia.com/features/95/8336/hot-start-ups-a-saga-of-the-worlds-fastest-dna-rna-stain-.html Mon, 23 May 2016 16:29:03 +0530 Both Dr Fathima Benazir (38) and Mr Alex Paul (38) were schoolmates and best childhood buddies. She was a postdoctoral research fellow at Indian Institute of Science (IISc), Bangalore, and was keenly looking out for opportunities abroad. She approached Mr Alex Paul and sent him her portfolio. The Unexpected Spark Intrigued by her profile and research accomplishments, Mr Paul persuaded her to apply her research to solve problems in different areas of Life Sciences. "I always wanted to be a passionate scientist rather than an entrepreneur," says Dr Fathima, Co-founder & CEO, Azooka Life Sciences. After several discussions and advice from her IISc mentors including Prof H S Savithri, Department of Biochemistry; Prof M R N Murthy, Molecular Biophysics Unit; and Dr C V Natraj, Advisor, Society for Innovation and Development (SID) IISc, she teamed up with co-founder Mr Alex and started Azooka Life Sciences in 2015. The name 'Azooka' is derived from the Spanish word AzÃºcar, which means sugar in Brazil. Significance Of Nucleic Acid Stain The Bangalore-based start-up is said to be the discoverer of a patent-pending nucleic acid gel stain developed from a plant source used as a food additive. The fluorescent dye named 'tinto rang' is a nucleic acid dye available for applications in Biological Sciences and Genomics. Nucleic acid stains are a vital part of DNA-based disease detection compared blood-based disease diagnostics. These stains are vital chemicals used in identifying diseases in human, animal and crop diseases. In fact, Nucleic Acid-based Testing (NAT) is a USFDA (United States Food and Drug Administration) approved and globally accepted methodology for non-invasive and rapid disease detection. NAT is said to be a precise and painless molecular testing technique. It is commonly available in the Americas, Europe, Malaysia and Thailand. "However this is not prevalent in India due to the high-cost of the assays and devices used in nucleic acid testing," Mr Paul comments. On an average, the NAT can cost anywhere between Rs 5,000 to Rs 15,000, and can go up to Rs 25,000, given that only expensive hospitals in cities provide the facility. "The conventional methods are inferior compared to NAT. It takes longer time, and the results can be negative because of longer incubation periods. Certainly nucleic acid tests are very specific, faster, accurate and way of the future," Dr Fathima voices. India's problem is that it has to import nucleic acids stains - mainly from the US or Germany. As a result, there is a payment of 40 to 50 percent import duty including transportation. Most nucleic acid stains are biohazards, toxic, carcinogenic, and mutagenic, and demands careful handling and disposal post experimentation. Nucleic acid stains are used on a daily basis in disease detection and DNA forensics, so disposing carcinogenic and hazardous substances is a major challenge. World's Safest Dye Right now, there are around 30 nucleic acid stains in the world that bind to DNA and RNA. They are widely used in DNA and RNA extraction, visualization and extensively in DNA Forensics, sequencing and genomic studies. Azooka claims its fluorescent dye as the world's safest and fastest DNA and RNA stain. It was conceived out of Dr Fathima's PhD research, and was launched in March 2016, after 3 long years of hard work and research. "Our nucleic acid stain is purely an Indian product, and our customers can save big on import duties. Our stain is the first nucleic acid stain to be reported in India and APAC," adds Mr Paul. The stain is said to be the safest and fastest DNA stain available in the market. "Our dye is faster than the market leading stains like Ethidium Bromide which takes 10 to 40 minutes to stain. Our dye consumes only 30 seconds," Mr Paul points. The start-up is planning a worldwide product launch by the end of 2016. "Our commercial wing Bhoot Enterprises will fulfil the product manufacturing, distribution, marketing, and sales in India. There are some regulatory and IP challenges in taking our products to market, but we are working under the guidance of SID..." Mr Paul reveals. Comparing NAT and ELISA (Enzyme-Linked Immunosorbent Assay), a test that detects and measures antibodies in the blood, the latter's test timeline can vary anywhere between 3 to 6 months. Azooka would focus on developing fluorescent dyes that can be used in multicolor labeling experiments such as FISH (Fluorescence in situ hybridization), FACS (fluorescence-activated cell sorting), chromosomal imaging, cell imaging, sequencing and other pharmacogenomics studies. "We are incubated for social impact, and we have a big mission. Our research is cutting-edge, but we didn't find the right market in India because molecular diagnostics is still nascent in the country. SID played an important role and recognized our innovation," she adds. Currently Azooka is seed funded and incubated at SID, IISc. The start-up operates only on research and innovation grants. "We want to purely be an IP- and R&D-based company by creating IPs and values. It is a big mistake to approach VCs immediately after conceiving your ideas. Once you discuss your ideas with VCs and if they are not convinced, you lose your ideas," he cautions. He emphasizes that once venture capitalists (VC) enter a start-up's picture, the focus of research changes. Mr Paul conceptualized most of the company's products, including the market research and the direction the start-up would take in the future. Prior to this, he was the director of product management and marketing at Zoho Corporation. Chasing Challenges DNA-based diagnoses is not so popular in India unlike it is in the US, Europe or Australia. "Educating the market about what we do is a challenge. Finding the right talent is another daunting task," Mr Paul shares. Since India does not have proper molecular diagnostic system in place, many times HIV-infected blood, for example, were given to kids. In such circumstances, Azooka's dye is said to play a crucial role in detecting such diabolical elements in samples. Funding Dramas Azooka's initial attempts to win grants proved tougher. "We were told to sell-off our technology and get settled for life. We were already running out of cash, and had a zero bank balance. But we didn't give up. We wanted to bring and build our innovative technology - the country's first nucleic acid stain -- right here in India," Dr Fathima states. While seeking funding, the start-up's final proposal was rejected by the committee since they claimed their technology as 'no novelty' status. "The committee is comprises of teachers and academicians who have very less knowledge about markets and entrepreneurship. Thus winning a grant is a challenge. The right system is not in place, and we had to pay a steep price," Mr Paul stresses. Azooka's products are targeted at blood banks, disease detection kit manufacturers, DNA-based diagnostic labs, DNA Forensics, academic institutions, universities, research labs, and companies in the pharmacogenomics space, seed companies in crop breeding and crop improvement, and medical device vendors. "We are also looking forward for Patent Cooperation Treaty (PCT) to protect our molecule for 30 months all across the world in 160 countries," Mr Paul comments. At IISc, Azooka has over 20 customers already. "We want to first win the home ground before a global launch. We also want to partner with kit vendors and molecular diagnostics device manufacturers," Dr Fathima opines. The start-up expressed interest in working with Roche Diagnostics, Danaher Corporation, Thermo Fisher Scientific, Qiagen and Bio-Rad among others. Grants Worth Rs 200 Cr The Karnataka's Millennium Biotech Policy is seen as a fantastic initiative by the Government. Start-ups believe that if the policy is executed well, it will further elevate Bangalore to a greater position. "About Rs 200 crore Government grants went unclaimed last year," reveals Mr Paul. "We need a one-window clearance system for start-ups. Currently there are no channels or ways through which entrepreneurs can know about availability of such fundings or accessing them. There is no proper communication between the Government and entrepreneurs to get those funds for research. There are fundings available in India and we want a place to go and look what is available. We want a portal where all the funding information is available. Applying for such funds are complicated. And most of them are archaic and old. Patenting and regulatory clearances seem expensive." In India, a mid-size DNA lab can cost up to $10 million. "...There is no proper ecosystem in the country in the area of application and the whole conducive ecosystem is missing. So all the great scientists go abroad, and also many companies hesitate to enter India," Mr Paul. In the West, entrepreneurs are seen to bootstrap and create value through their start-ups, or even just start off with uncertainties and slowly execute their strategy. "It is all about impacting billions and not putting billions into your bank account," Mr Paul mentions. Bare Ecosystem He feels that the country does not even have websites to gain knowledge on trends happening in Biological Sciences. "The whole ecosystem is bare. We are following trends abroad. Personalization of medicine is creating a major trend globally. Gene banking is coming to India through Apollo Hospitals and Narayana Hrudayalaya where genes are going to be stored. We also do not have enough news and publications to know what is happening in our space and what companies are working on," he expresses. He says that in vitro diagnostic device (IVD) and in vivo imaging space is very nascent in India. "I wish a lot of start-ups would venture in to it. We need an ecosystem where reagents are made by ourselves which would bring down costs of research and diagnosis. We need to push the Government to make NAT mandatory. Most Life Sciences companies explore NGS or bigdata and are not product-based by creating IPs. IPs should stay within India rather than other countries trying to take it, like in the case of Turmeric and Neem," Mr Paul suggests. "Indian patent laws are stringent, and this is what is helping the country not lose its IPs and natural resources to other countries," notes Dr Fathima. Biggest Lessons Mr Paul says that an entrepreneur needs tons of patience and perseverance in the journey. "Unlike IT, there are no alpha or beta versions of products in Life Sciences and medicine. Products need to be specific and stable," he advises. He advises start-ups to try their hands at funding methods like government grants which is valued at around Rs 800 crore. He also says that for Biotech start-ups, Bangalore is the best place to begin. Ahmedabad and Hyderabad are seen favorable for pharma start-ups. "A start-up is a small slice of the problem where an entrepreneur tries to solve it. Start-ups never die. They commit suicide. When people in a start-up stop caring about it, it eventually dies," says Mr Paul, quoting his ex-CEO Mr Sridhar Vembu of Zoho Corp. As for Mr Paul, association with SID and IISc has a left a lasting impact on his career direction. "In a typical IT start-up, the pinnacle of success is seen as landing a job at Silicon Valley at companies like Microsoft, Google or Facebook or a unicorn start-up with billion dollar evaluations; or having millions of dollars in the bank; or even being featured on the cover page of popular magazines," he says. He explains, "But my journey led me to meet scientists at IISc, who were solving the world's toughest problems like curing diseases or finding drugs and vaccines in India. A silent fight to make India a better place. They are the really happy people. They are humbled by the problems of the world, and try to help the humanity. Our families had a tough time comprehending what we were doing. "Being an expert in the IT services management, I even got a permanent residency to Australia. But we wanted to create a huge social impact in our homeland. People today will instantly judge you by looks. There is so much prejudice even before you hit the market. And Dr Fathima is a role model. There are women entrepreneurs struggling to make it in this space. But she made it despite challenges!" Being a woman, the journey had been quite uniquely challenging for Dr Fathima. "It takes a lot of courage because it isn't easy for a researcher to make a switch from being a scientist to an entrepreneur. Single-minded focus is also very important. You will encounter failures but every time you have to continue to move on no matter what. It is important to have passionate co-founders; to some extent you have to be selfless. For a Life Sciences start-up, it may at least take 5 years to get the product to the market," she elaborates. "It has been challenging personally and professionally. Being a woman, the challenges doubled. The first best lesson I have learnt is to believe in myself. Believing in what I did. I believe that attitude will take you from where you are to where you want to go. Don't let your circumstances, family, or society pressurize you to lose that faith in yourself. That's the biggest battle I fought. I isolated myself from shame and insults and believed in what I did. "Once you lose faith in what you are doing then the purpose is lost. Associate with people who believe in you. For us, this is just the beginning of the journey. We have a lot to learn. It's a team work. My parents too gave me the liberty to do what I wanted to do. Never allow anyone to dictate your dreams," ends Dr Fathima gracefully. She is a mother of 2 kids and enjoys cooking and knitting. Wisdom Pills For Start-ups: â–ª Associating with right business partners, marketersâ–ª Expertise in chosen fieldâ–ª Finding good patent lawyersâ–ª Finding passionate team, right advisorsâ–ª Good fund managementâ–ª Regulatory awareness Myths To Debunk: â–ª Impossible to transition from IT to Life Sciencesâ–ª Product development takes 10-20 years ]]> <![CDATA[Distinction between genetic engineering and conventional plant breeding becoming less clear, says new report on GE crops]]> https://biospectrumindia.com/news/95/6907/distinction-between-genetic-engineering-and-conventional-plant-breeding-becoming-less-clear-says-new-report-on-ge-crops.html https://biospectrumindia.com/news/95/6907/distinction-between-genetic-engineering-and-conventional-plant-breeding-becoming-less-clear-says-new-report-on-ge-crops.html Fri, 20 May 2016 10:54:15 +0530 An extensive study by the National Academies of Sciences, Engineering, and Medicine has found that new technologies in genetic engineering and conventional breeding are blurring the once clear distinctions between these two crop-improvement approaches. In addition, while recognizing the inherent difficulty of detecting subtle or long-term effects on health or the environment, the study committee found no substantiated evidence of a difference in risks to human health between current commercially available genetically engineered (GE) crops and conventionally bred crops, nor did it find conclusive cause-and-effect evidence of environmental problems from the GE crops. However, evolved resistance to current GE characteristics in crops is a major agricultural problem. A tiered process for regulating new crop varieties should focus on a plant's characteristics rather than the process by which it was developed, the committee recommends in its report. New plant varieties that have intended or unintended novel characteristics that may present potential hazards should undergo safety testing -- regardless of whether they were developed using genetic engineering or conventional breeding techniques. New "-omics" technologies, which dramatically increase the ability to detect even small changes in plant characteristics, will be critical to detecting unintended changes in new crop varieties. The committee used evidence accumulated over the past two decades to assess purported negative effects and purported benefits of current commercial GE crops. Since the 1980s, biologists have used genetic engineering to produce particular characteristics in plants such as longer shelf life for fruit, higher vitamin content, and resistance to diseases. However, the only genetically engineered characteristics that have been put into widespread commercial use are those that allow a crop to withstand the application of a herbicide or to be toxic to insect pests. The fact that only two characteristics have been widely used is one of the reasons the committee avoided sweeping, generalized statements about the benefits and risks of GE crops. Claims about the effects of existing GE crops often assume that those effects would apply to the genetic engineering process generally, but different characteristics are likely to have different effects. A genetically engineered characteristic that alters the nutritional content of a crop, for example, is unlikely to have the same environmental or economic effects as a characteristic for herbicide resistance. The committee examined almost 900 research and other publications on the development, use, and effects of genetically engineered characteristics in maize (corn), soybean, and cotton, which account for almost all commercial GE crops to date. "We dug deeply into the literature to take a fresh look at the data on GE and conventionally bred crops," said committee chair Mr Fred Gould, University Distinguished Professor of Entomology and co-director of the Genetic Engineering and Society Center at North Carolina State University. In addition, the committee heard from 80 diverse speakers at three public meetings and 15 public webinars, and read more than 700 comments from members of the public to broaden its understanding of issues surrounding GE crops. Effects on human health. The committee carefully searched all available research studies for persuasive evidence of adverse health effects directly attributable to consumption of foods derived from GE crops but found none. Studies with animals and research on the chemical composition of GE foods currently on the market reveal no differences that would implicate a higher risk to human health and safety than from eating their non-GE counterparts. Though long-term epidemiological studies have not directly addressed GE food consumption, available epidemiological data do not show associations between any disease or chronic conditions and the consumption of GE foods. There is some evidence that GE insect-resistant crops have had benefits to human health by reducing insecticide poisonings. In addition, several GE crops are in development that are designed to benefit human health, such as rice with increased beta-carotene content to help prevent blindness and death caused by vitamin A deficiencies in some developing nations. Effects on the environment. The use of insect-resistant or herbicide-resistant crops did not reduce the overall diversity of plant and insect life on farms, and sometimes insect-resistant crops resulted in increased insect diversity, the report says. While gene flow - the transfer of genes from a GE crop to a wild relative species - has occurred, no examples have demonstrated an adverse environmental effect from this transfer. Overall, the committee found no conclusive evidence of cause-and-effect relationships between GE crops and environmental problems. However, the complex nature of assessing long-term environmental changes often made it difficult to reach definitive conclusions. Effects on agriculture. The available evidence indicates that GE soybean, cotton, and maize have generally had favorable economic outcomes for producers who have adopted these crops, but outcomes have varied depending on pest abundance, farming practices, and agricultural infrastructure. Although GE crops have provided economic benefits to many small-scale farmers in the early years of adoption, enduring and widespread gains will depend on such farmers receiving institutional support, such as access to credit, affordable inputs such as fertilizer, extension services, and access to profitable local and global markets for the crops. Evidence shows that in locations where insect-resistant crops were planted but resistance-management strategies were not followed, damaging levels of resistance evolved in some target insects. If GE crops are to be used sustainably, regulations and incentives are needed so that more integrated and sustainable pest-management approaches become economically feasible. The committee also found that in many locations some weeds had evolved resistance to glyphosate, the herbicide to which most GE crops were engineered to be resistant. Resistance evolution in weeds could be delayed by the use of integrated weed-management approaches, says the report, which also recommends further research to determine better approaches for weed resistance management. Insect-resistant GE crops have decreased crop loss due to plant pests. However, the committee examined data on overall rates of increase in yields of soybean, cotton, and maize in the U.S. for the decades preceding introduction of GE crops and after their introduction, and there was no evidence that GE crops had changed the rate of increase in yields. It is feasible that emerging genetic-engineering technologies will speed the rate of increase in yield, but this is not certain, so the committee recommended funding of diverse approaches for increasing and stabilizing crop yield. Regulation Should Focus on Novel Characteristics and Hazards All technologies for improving plant genetics - whether GE or conventional -- can change foods in ways that could raise safety issues, the committee's report notes. It is the product and not the process that should be regulated, the new report says, a point that has also been made in previous Academies reports. In determining whether a new plant variety should be subject to safety testing, regulators should focus on the extent to which the novel characteristics of the plant variety (both intended and unintended) are likely to pose a risk to human health or the environment, the extent of uncertainty about the severity of potential harm, and the potential for human exposure - regardless of whether the plant was developed using genetic-engineering or conventional-breeding processes. " -omics" technologies will be critical in enabling these regulatory approaches. The United States' current policy on new plant varieties is in theory a "product" based policy, but USDA and EPA determine which plants to regulate at least partially based on the process by which they are developed. But a process-based approach is becoming less and less technically defensible as the old approaches to genetic engineering become less novel and as emerging processes - such as genome editing and synthetic biology - fail to fit current regulatory categories of genetic engineering, the report says. The distinction between conventional breeding and genetic engineering is becoming less obvious, says the report, which also reviews emerging technologies. For example, genome editing technologies such as CRISPR/Cas9 can now be used to make a genetic change by substituting a single nucleotide in a specific gene; the same change can be made by a method that uses radiation or chemicals to induce mutations and then uses genomic screening to identify plants with the desired mutation - an approach that is considered to be conventional breeding by most national regulatory systems. Some emerging genetic engineering technologies have the potential to create novel plant varieties that are hard to distinguish genetically from plants produced through conventional breeding or processes that occur in nature. A plant variety that is conventionally bred to be resistant to a herbicide and one that is genetically engineered to be resistant to the same herbicide can be expected to have similar associated benefits and risks. Regulating authorities should be proactive in communicating information to the public about how emerging genetic-engineering technologies or their products might be regulated and how new regulatory methods may be used. They should also proactively seek input from the public on these issues. Not all issues can be answered by science alone, the report says. Policy regarding GE crops has scientific, legal, and social dimensions. For example, on the basis of its review of the evidence on health effects, the committee does not believe that mandatory labeling of foods with GE content is justified to protect public health, but it noted that the issue involves social and economic choices that go beyond technical assessments of health or environmental safety; ultimately, it involves value choices that technical assessments alone cannot answer. The study was sponsored by the Burroughs Wellcome Fund, the Gordon and Betty Moore Foundation, the New Venture Fund, and the U.S. Department of Agriculture, with additional support from the National Academy of Sciences. The National Academies of Sciences, Engineering, and Medicine are private, nonprofit institutions that provide independent, objective analysis and advice to the nation to solve complex problems and inform public policy decisions related to science, technology, and medicine. They operate under an 1863 congressional charter to the National Academy of Sciences, signed by President Lincoln. ]]> <![CDATA[Medtronic launches Spine Essentials ]]> https://biospectrumindia.com/news/95/8290/medtronic-launches-spine-essentials-.html https://biospectrumindia.com/news/95/8290/medtronic-launches-spine-essentials-.html Fri, 20 May 2016 10:53:28 +0530 Medtronic has announced the US launch of Spine Essentials, a new platform of spinal implants and instruments designed to make the most common cervical spine fusion procedures more efficient and help hospital systems manage costs, while maintaining quality. The goal of Spine Essentials is to help surgeons and their staffs streamline the most common spinal fusions, by providing the exact tools in the right quantities needed to perform 1- and 2-level cervical spinal fusions, while reducing the costs and time required for instrument sterilization, case set up and inventory management. Spine Essentials was developed in collaboration with leading surgeons and administrators and launched today at the Ambulatory Surgical Center Association (ASCA) annual meeting in Dallas. "As a surgeon who routinely performs these types of surgeries, it's helpful to optimize the implants and tools, so we're being as efficient as possible to provide the best care possible to our patients," said Dr Richard NW Wohns, orthopedic surgeon at neoSpine in Puyallup, WA and one of the physicians who collaborated with Medtronic to develop the platform. To develop Spine Essentials, Medtronic partnered with healthcare systems across the US to evaluate unmet needs and identify efficiencies. Spine Essentials implant sets include the most commonly used implant sizes for 1- and 2-level fusions of the neck (anterior cervical discectomy and fusions) and are sterile packaged with smaller instrument sets; thereby reducing the amount of inventory a hospital needs to sterilize, set up and store. This platform will reduce sterilization costs associated with the procedure, including:â€¢~44 percent fewer instruments to sterilize compared with the full-sized configurations.â€¢91 percent fewer items to sterilize compared with the full-sized instrument and implant sets.â€¢67 percent reduction in number of cases to sterilize compared with the full-sized instrument and implant sets. "Healthcare systems are under intense economic challenges, and Spine Essentials is an example of how Medtronic can bring value to spine surgery by optimizing costs and efficiency," said Mr Doug King, senior vice president and president of Medtronic's Spinal business, which is part of the Restorative Therapies Group at Medtronic. "We're committed to delivering successful patient outcomes more efficiently, but we can't do it alone which is why Spine Essentials was developed with the input of physicians and hospitals." Spine Essentials incorporates technology developed by Dr Gary K Michelson. ]]> <![CDATA[WHO South-East Asia Region on track for implementing polio endgame strategy]]> https://biospectrumindia.com/news/95/7040/who-south-east-asia-region-on-track-for-implementing-polio-endgame-strategy.html https://biospectrumindia.com/news/95/7040/who-south-east-asia-region-on-track-for-implementing-polio-endgame-strategy.html Thu, 19 May 2016 16:57:32 +0530 Implementing a monumental change in vaccination that is expected to bring the world closer to eradicating all types of polio, all 11 countries in the WHO South-East Asia Region have "switched" from using the traditionally used trivalent oral polio vaccine (tOPV) to bivalent oral polio vaccine (bOPV) that protects against the remaining wild poliovirus strains. The vaccine switch removing 'type 2' component of the oral polio vaccine follows global certification of eradication of type 2 wild poliovirus last year. The switch also aims at drastically reducing the rare risk of children getting paralysis by oral polio vaccine. "The world is closer than ever before to ending polio. The switch is a critical step in the Polio Endgame Strategy towards achieving a world free of all types of polioviruses," said Dr Poonam Singh, WHO Regional Director for South-East Asia. The polio vaccine switch, which is complemented with introduction of injectable inactivated polio vaccine (IPV), will boost the Region's efforts to protect children against polio until the crippling disease is eradicated globally. "The Region was certified polio-free in March 2014 and continues to maintain the polio-free status, despite the risk of importation from the polio-endemic countries. Efforts are ongoing to protect children with polio vaccine, increase routine immunization coverage, focus on the most vulnerable and hard to reach population and step-up vigil against poliovirus importation," she added. "I would like to congratulate all countries in the Region for successfully implementing the polio vaccine switch, which is the biggest globally coordinated project of its kind in the history of vaccines involving over 150 countries. Countries in the Region made extensive preparations, meticulously planned and implemented the switch in the childhood immunization programme which reaches out to an estimated 37 million children in the 11 countries of the Region annually," Dr Poonam further commented. ]]> <![CDATA[Chinese Pharma firm Fosun bids to buy Gland Pharma: Reports]]> https://biospectrumindia.com/news/95/8289/chinese-pharma-firm-fosun-bids-to-buy-gland-pharma-reports.html https://biospectrumindia.com/news/95/8289/chinese-pharma-firm-fosun-bids-to-buy-gland-pharma-reports.html Thu, 19 May 2016 11:02:06 +0530 Shanghai based Fosun Pharmaceutical have submitted a non-binding proposal to acquire a 96 percent stake in India's Gland Pharma, says reports. Fosun Industrial Co. Ltd, a unit of the Chinese drug maker, made a non-binding proposal to existing shareholders of Gland Pharma, the company said in a statement to the Hong Kong stock exchange. Private equity firm KKR and Co. owns a significant minority stake in Gland Pharma. "As at the date of this announcement, the non-binding proposal is still in a bidding process on a non-exclusive basis, which shall be confirmed by the relevant parties pending the selection and acceptance by the existing shareholders of Gland," the firm added. In the event that the non-binding proposal made by Fosun Industrial is successful, "it will enhance and improve the Group's drug manufacture and research and development capacity and the degree of internationalization," the statement further said. Established in 1978 and based in Hyderabad, Gland Pharma develops and manufactures generic injectables, primarily for the US market. It also sells its products in India and other semi-regulated markets. Its manufacturing facilities are approved by the US and UK drug regulators. ]]> <![CDATA[Pharma exports growth heading for a sharp decline: CRISIL Research]]> https://biospectrumindia.com/news/95/6674/pharma-exports-growth-heading-for-a-sharp-decline-crisil-research.html https://biospectrumindia.com/news/95/6674/pharma-exports-growth-heading-for-a-sharp-decline-crisil-research.html Wed, 18 May 2016 17:20:56 +0530 CRISIL Research foresees exports growth in formulations (in US dollar terms) decling sharply to 10-125 annually over the next 5 years, compared with a growth of 19% seen in the last decade. Exports of generics have been the growth engine of the industry for a long hile now, but the script is changing because the value of drugs going off patent is declining even as pricing pressures are increasing. for example, annual sales growth of generic drus in US is seen slowing to 8-9% over the next five years, and decelerate even more after that. Therefore, for growth to sustain beyond 2020, domestic companies will have to step up investments in new molecules and draw up a roadmap to deal with lower generics growth. In the past decade and more, what came in handy was process chemistry skills--which helped companies clone drugs going off-patent by tweaking their molecules--and low-cost manufacturing. But competition has been intensfying, particularly for the large players, because of the huge number of abbreviated new drug applications (ANDAs) being filed with the USFDA, including by mid-sized domestic ones looking to step up presence in the biggest market. Furthermore, consolidation of distribution channels in the US could reduce the pricing power of domestic drug makers. Says Ajay Srinivasan, Director CRISIL Research,"Sharper focus on innovation and R&D has become an imperative. Our analysis of new drug applications approved by USFDA reveals that Indian companies got approvals for just 26 products between Jan 2006 and June 2015- a fraction of the 840 garnered by global pharma companies. Their global generic competitors such as Teva and Mylan has 48 and 33 NDAs to their credit as of Feb 2016." To be sure, Indian companies have indeen increased their R&D spend; for the top 30, it has shot up to 6.5% of revenue fiscal 2015 from 3.8% a decade back. Howver, this pales in comparison with global majors, who spend close to 16%. Typically, a chunk of the expenditure of domestic pharma companies for launching generic therapies, changing product mix in generics and process development. Some top one have launched R&D programmes aimed at new drug discovery. CRISIL Research's analysis indicates that a good 14 companies together have 39 products in various stages of clinical development. These companies have adopted various approaches-such as inhouse development, joint development and out licensing-to manage the risk return trade off. However, none has launched a new molecule in a regulated market such as the US. ]]> <![CDATA[Merck, Pfizer's combination immunotherapy set to become integral element of Renal Cell Carcinoma treatment]]> https://biospectrumindia.com/features/95/6215/merck-pfizers-combination-immunotherapy-set-to-become-integral-element-of-renal-cell-carcinoma-treatment.html https://biospectrumindia.com/features/95/6215/merck-pfizers-combination-immunotherapy-set-to-become-integral-element-of-renal-cell-carcinoma-treatment.html Wed, 18 May 2016 13:13:55 +0530 Merck KGaA and Pfizer's Phase III JAVELIN Renal 101 trial, which will assess the combination of the checkpoint inhibitor avelumab and Pfizer's anti-angiogenesis tyrosine kinase inhibitor (TKI) Inlyta (axitinib) in the first-line renal cell carcinoma (RCC) setting, is the most likely immunotherapy combination to be first to market in the treatment space, according to an analyst with research and consulting firm GlobalData. As explored in the company's latest RCC report, Bristol Myers Squibb's (BMS) checkpoint inhibitor Opdivo (nivolumab) will be an important driver of growth over the next few years. After the drug's approval in November 2015 in the US and February 2016 in Europe, it established immunotherapy as the new standard of care in recurrent RCC. Dr Maxime Bourgognon, GlobalData's Analyst covering Oncology and Hematology explains: "BMS is trialing Opdivo in combination with another checkpoint inhibitor, Yervoy (ipilimumab), an approach that results in a synergistic mechanism of action. This is different to Merck KGaA and Pfizer's use of TKIs, which has shown the ability to reduce myeloid-derived suppressor cells, alleviating the immunosuppression by the tumor and enhancing the efficacy of immunotherapies. "It is difficult to accurately predict which approach is clinically more promising; however, GlobalData believes that the safety profiles of the combination agents will play a key role in their establishment as standard of care in first-line RCC. Indeed, Inlyta is one of the safest TKIs currently approved for RCC, making its combination with avelumab promising. "In comparison, combining the checkpoint inhibitors Opdivo and Yervoy could alter their safety profiles, as has been seen in melanoma, where the combination is approved with a boxed warning for severe and fatal immune-mediated adverse reactions. The Inlyta and avelumab combination also holds a distinct advantage in that it is likely to hit the market before BMS's combination." Combination approaches have the potential to generate twice as many sales in the recurrent RCC market as Opdivo, by increasing the number of patients able to benefit from immunotherapies and extending the length of time during which patients receive immunotherapy treatment. Dr Bourgognon concludes: "GlobalData anticipates that the launch of combinations with checkpoint inhibitors will have a major impact to the RCC treatment paradigm, with the avelumab and Inlyta combination becoming the standard of care due to its first-to-market position and its synergistic efficacy and safety attributes." ]]> <![CDATA[PurpleHealth.com raises USD 100,000 from Katabole Technology Venture]]> https://biospectrumindia.com/news/95/5627/purplehealth-com-raises-usd-100000-from-katabole-technology-venture.html https://biospectrumindia.com/news/95/5627/purplehealth-com-raises-usd-100000-from-katabole-technology-venture.html Wed, 18 May 2016 10:24:43 +0530 PurpleHealth.com has raised USD 100,000 from Katabole Technology Venture. Founded in 2014, PurpleHealth.com is a 360-degree health and wellness platform that delivers a diverse spectrum of solutions, services and products to consumers, corporates, healthcare providers and institutions. The platform empowers consumers to take active control of their health by providing a one-stop seamless interface to choose the right medical practitioners, schedule appointments, set up video & audio chats with doctors and much more, thus helping them better manage their health and wellness interactions. Furthermore, PurpleHealth enables healthcare providers with tools and technologies that assist them to better engage with their customers. The platform currently has over 38,000 doctors and 4000 hospitals as part of its vast and growing network. Vikram Nair, Co-founder & CEO, PurpleHealth.com says, " The Indian healthcare sector is expected to register a compounded annual growth rate (CAGR) of 22.9% during 2015-20 and grow to USD 280 billion. We intend to play a substantial part in that growth story by creating a massive, positive impact on how health & wellness products and services are accessed by and delivered to every individual, corporate & institution." He adds, "We will use this round of funding to further build on the PurpleHealth.com product roadmap and strengthen the team." Balaji Jagannathan, Founder & CEO, Katabole says, "We believe that when it comes to health, people today, by and large, feel disempowered. They want the ability to choose and decide by themselves and they crave the right platform that will give them access to all the information they need to make their health-related decisions." ]]> <![CDATA[Monsanto researchers showcase new breakthrough in protein science]]> https://biospectrumindia.com/news/95/8388/monsanto-researchers-showcase-new-breakthrough-in-protein-science.html https://biospectrumindia.com/news/95/8388/monsanto-researchers-showcase-new-breakthrough-in-protein-science.html Tue, 17 May 2016 17:17:51 +0530 Research published today is poised to deliver never-before-seen breakthroughs for the role of protein science in agriculture and lead to new innovations for farmers and society. The advance, the application of PACE (phage-assisted continuous evolution) technology to generate novel insect control traits for crops, demonstrates the ability to optimize proteins to convey specific benefits to plants or to specifically target pests and pathogens of plants - paving the way to target pests that have developed resistance to prior agriculture solutions. Researchers at Monsanto Company and Harvard University have published the results of a recent study using PACE technology in Nature. The manuscript titled 'Continuous evolution of Bacillus thuringiensis toxins overcomes insect resistance', showcases how the new application of protein science can be practically applied to agriculture. Co-authors of the paper from Cornell University provided contributions to enable this published work, which was initiated under an ongoing research collaboration between Monsanto and Harvard University on PACE technology. PACE technology was originally invented in the Harvard laboratory of Dr. David Liu, Professor of Chemistry and Chemical Biology, who is also a Howard Hughes Medical Institute Investigator. Dr. Liu and his lab developed this tool as a way to create, identify and evolve optimized proteins, up to 100 times faster than previous methods. The ability to speed the discovery of improved and optimized proteins enables faster advancements in the improvement of crops, as proteins are the central building blocks to the agronomic traits farmers' value, such as insect control and herbicide tolerance. At a time when farmers are battling a changing climate and volatile weather, which often results in increased pest pressure on a faster time horizon, it becomes increasingly important to drive new innovations in agriculture more quickly."Scientific breakthroughs like PACE technology are key to continue bringing solutions to farmers to help them get more out of every acre," said Tom Adams, Vice President of Biotechnology at Monsanto. "The remarkable progress that's been made in applying PACE to agriculture biotechnology is a huge testament to the success that comes when parties work together and collaborate to advance science in a way that can bring long-term benefits to global agriculture." Monsanto and Harvard initiated their ongoing collaboration on PACE technology in 2013, and Monsanto has since entered into a limited-term, exclusive license agreement with Harvard for the use of this technology for agricultural applications."The research published in Nature is an important demonstration of David Liu's PACE platform, validating its potential as a tool not only for agriculture, where it can address compelling scientific challenges, but across diverse areas of future application including health care, where it could evolve tailor-made therapies for human disease," says Isaac T. Kohlberg, Harvard's Senior Associate Provost and Chief Technology Development Officer. "The PACE collaboration is just one example of how researchers in academia and industry can pool their expertise to advance science in areas of mutual interest and speed the development of impactful technologies." Farmers are continually challenged by effects of a changing climate, including increased insect pressure, disease and weed infestations. A broad-range of agriculture solutions are critical to help farmers address and manage these on-farm challenges in a sustainable way. Collaborating on the advancement of science in agriculture, in addition to driving key scientific breakthroughs like PACE technology, will continue to be critical in helping farmers mitigate these challenges, and ultimately provide sustainable solutions to increase yields and improve harvests. ]]> <![CDATA[Demand for biobanking resources continues to increase despite ethical, financial concerns]]> https://biospectrumindia.com/features/95/3531/demand-for-biobanking-resources-continues-to-increase-despite-ethical-financial-concerns.html https://biospectrumindia.com/features/95/3531/demand-for-biobanking-resources-continues-to-increase-despite-ethical-financial-concerns.html Tue, 17 May 2016 14:00:33 +0530 The company's latest CBR Pharma report states that biobanks have various useful applications for clinical researchers, including leveraging samples and genetic data to accelerate the development of companion diagnostics, helping to reduce development times and costs for new medicines, and supporting knowledge creation and scientific discovery across a range of disciplines. Mr Rodrigo Gutierrez Gamboa, Managing Analyst for GBI Research, says: "Clinical trials and epidemiological studies have contributed to improved understanding of certain diseases but, with the growth of biotechnology and phenotypic information, there is a need for the involvement of biobanks in such trials. The main aim of clinical trial-related biobanking is to identify and provide disease or trial-associated biomarkers. "The integration of novel tools such as Big Data techniques, coupled with the increasing industry need for high-quality biospecimens for research, will lead to expanding cell and tissue collections, ultimately resulting in increased biobank usage." Despite the useful applications of biobanking, the creation and endurance of biobanks depends on people's willingness to donate and have their samples stored. In this way, community engagement is a central component of biobanking governance, as the participation and support of the public is important for the success of any biobank. Mr Gutierrez Gamboa explains: "The public's attitude towards biobanking is mixed, with some people having concerns over disclosing personal and medical information. Public support also depends to a large extent on what the samples are used for, as the treatment of disease is generally valued highly, while other interventions that aim to impact areas such as cosmetics or gender-reassignment are seen as less acceptable." Another obstacle to the further development of biobanks is their high cost, combined with the risk involved with long-term investment that relies upon a number of financial unknowns. The analyst concludes: "Most biobanks are reportedly employing relatively vague cost models, suggesting a lack of financial strategy. Failure to accurately capture costs may lead to the early termination of projects, and may prove to be the downfall of various biobanks." ]]> <![CDATA[AZ, Plan India launch YHP Phase III]]> https://biospectrumindia.com/news/95/3528/az-plan-india-launch-yhp-phase-iii.html https://biospectrumindia.com/news/95/3528/az-plan-india-launch-yhp-phase-iii.html Tue, 17 May 2016 13:59:38 +0530 Plan India, a member of Plan International Federation, is a nationally registered independent child development and humanitarian organization committed to enabling vulnerable and marginalized children, their families and communities to be free of poverty, violence and injustice. The third phase of the YHP aims to reach out to an additional 130,000 young boys and girls. This phase was started this May through a door-to-door campaign where 1,000 peer educators and youth volunteers sensitized community members on the dangers of heat waves and precautions to take. The campaign was rolled out in the resettlement colonies of New Delhi covering Sultanpuri, Kirari Suleman Nagar, Jahangirpuri, Bawana and Holambi Khurd, reaching out to more than 20,000 households and more than one lakh individuals. There is an immense urgency to work on adolescent health issues in India: â€¢ One-fifth of India's total population, approximately 253 million, are adolescents, i.e. in the age group 10-19 years.â€¢ The mean age of onset of tobacco use is 12.3 years.â€¢ Of all children that are addicted to substances such as tobacco and alcohol, nearly 69.8% were from urban areas and 28% were currently studying in a regular school.â€¢ Half of adolescents (boys and girls) have below normal body mass index (BMI) and almost 56% of adolescent girls aged 15-19 years have anaemia.â€¢ Over 35% of AIDS cases reported are below 25 years of age and 50% of new infections are between 15 and 24 years old. Ms Bhagyashri Dengle, Executive Director, Plan India stated, "YHP is a crucial programme for Plan India within our Country Strategic Plan 2020. Given our strategic goal to improve health and hygiene practices through active youth engagement, the YHP provides an ideal platform for long-term, sustainable impact among the communities with whom Plan India works." Mr Sanjay Murdeshwar, Managing Director, AstraZeneca Pharma India Limited commented, "YHP is an important program that reflects AstraZeneca's meaningful contribution towards improving access to healthcare. YHP helps build the knowledge and capacity of young people and empower them to make informed life choices. YHP reaches out to the community members and stakeholders to enhance awareness of the inter-generational effects of risk behavior, while contributing towards a collaboration to address risks in non-communicable diseases (NCDs) especially in diabetes. We also are committed to support research programmes that help generate the evidence required to prioritize adolescent health and the prevention of NCDs." For over 35 years, Plan India and its partners have supported over a million children access their rights to protection, basic education, proper healthcare, a healthy environment, livelihood opportunities and participation in decisions which affect their lives. ]]> <![CDATA[Pfizer to acquire Anacor for $5.2 billion]]> https://biospectrumindia.com/news/95/6648/pfizer-to-acquire-anacor-for-5-2-billion.html https://biospectrumindia.com/news/95/6648/pfizer-to-acquire-anacor-for-5-2-billion.html Tue, 17 May 2016 13:01:53 +0530 Pfizer and Anacor Pharmaceuticals, has announced that they have entered into a definitive merger agreement under which Pfizer will acquire Anacor for $99.25 per Anacor share, in cash, for a total transaction value, net of cash, of approximately $5.2 billion, which assumes the conversion of Anacor's outstanding convertible notes. The Boards of Directors of both companies have unanimously approved the transaction. Anacor's flagship asset, crisaborole, a differentiated non-steroidal topical PDE4 inhibitor with anti-inflammatory properties, is currently under review by the US FDA for the treatment of mild-to-moderate atopic dermatitis, commonly referred to as eczema. "We believe the acquisition of Anacor represents an attractive opportunity to address a significant unmet medical need for a large patient population with mild-to-moderate atopic dermatitis, which currently has few safe topical treatments available," said Mr Albert Bourla, Group President of Pfizer's Global Innovative Pharma and Global Vaccines, Oncology and Consumer Healthcare Businesses. "Crisaborole is a differentiated asset with compelling clinical data that, if approved, has the potential to be an important first-line treatment option for these patients and the physicians who treat them." In both of its Phase 3 pivotal studies, crisaborole achieved statistically significant results on all primary and secondary endpoints and in March 2016, the FDA accepted for review Anacor's New Drug Application seeking approval of crisaborole for the potential treatment of mild-to-moderate atopic dermatitis in children and adults. The Prescription Drug User Fee Act (PDUFA) goal date for the completion of the FDA's review is January 7, 2017. If approved, Pfizer believes peak year sales for crisaborole have the potential to reach or exceed $2.0 billion. "Today marks the beginning of an exciting new chapter for Anacor, which we believe will deliver significant value to our shareholders," said Mr Paul L. Berns, Anacor's chairman and CEO. "We have a deep respect for Pfizer, and it is clear that they share our commitment to addressing the significant unmet medical needs in inflammatory disease. We are proud of the innovative company that our team has built and are confident that Pfizer will help accelerate Anacor's important mission given the strength of its global platform and resources." Atopic dermatitis is a common, relapsing, chronic, inflammatory skin disorder, with patients displaying a chronic rash characterized by inflammation and itching, often occurring in folds of the skin with symptoms lasting up to 14 days or more. Approximately 18 to 25 million people in the United States suffer from this condition, including between 8 and 18% of infants and children. Atopic dermatitis has been considerably underdiagnosed due to the lack of approved effective systemic agents, and limitations of current topical agents. There have been no new molecular entities for atopic dermatitis in the last 15 years. Anacor also holds the rights to Kerydin, a topical treatment for onychomycosis (toenail fungus) that is distributed and commercialized by Sandoz Inc. in the U.S. Pfizer anticipates financing the transaction through existing cash. Pfizer does not expect the transaction to impact its current 2016 financial guidance. Pfizer expects the transaction to be slightly dilutive to Adjusted Diluted Earnings Per Share (EPS)(1) in 2017 with accretion to Adjusted Diluted EPS(1) beginning in 2018 and increasing thereafter. Under the terms of the merger agreement, a subsidiary of Pfizer will commence a cash tender offer to purchase all of the outstanding shares of Anacor common stock for $99.25 per share in cash. The closing of the tender offer is subject to customary closing conditions, including U.S. antitrust clearance and the tender of a majority of the outstanding shares of Anacor common stock. The merger agreement contemplates that Pfizer will acquire any shares of Anacor that are not tendered into the offer through a second-step merger, which will be completed promptly following the closing of the tender offer. Pfizer expects to complete the acquisition in the third-quarter 2016. Pfizer's financial advisors for the transaction were Centerview Partners and Guggenheim Securities, and Wachtell, Lipton, Rosen & Katz acted as its legal advisor. Citi served as Anacor's financial advisor, and Davis Polk & Wardwell, LLP served as its legal advisor. ]]> <![CDATA[India turns to Ayurveda to curb dengue]]> https://biospectrumindia.com/news/95/8339/india-turns-to-ayurveda-to-curb-dengue.html https://biospectrumindia.com/news/95/8339/india-turns-to-ayurveda-to-curb-dengue.html Mon, 16 May 2016 16:13:23 +0530 Indian drug giant Sun Pharma has inked a deal with global non-profit International Centre for Genetic Engineering and Biotechnology (ICGEB) to develop a novel botanical drug that can combat the menace of dengue. The drug, Cipa, has its roots in traditional Ayurvedic medicine. The project is backed and supported by the Department of Biotechnology (DBT) and Ministry of Science and Technology. The Cipa drug also aims to push towards traditional medicine by the current government, as acknowledged by Dr Khanna and Dr Altaf Lal, senior advisor with Sun Pharma. The eight year long research is led by Dr Naveen Khanna of the ICGEB. Speaking to the media Mr Khanna said, "It is high time that India wake up and create these drugs with the help of modern science. USFDA approved four botanical drugs from China last year. Four years from now, India could have a pill for curative and even preventive dengue therapy." Nearly 10,000 cases of dengue were reported from the national capital last year in one of the worst ever outbreaks of dengue in the country. The drug, Dr khanna explained, is derived from the plant Cissampelos pareira Linn, commonly known as abuta, and laghu patha in ayurveda. Its extract has shown to inhibit all four strains of dengue (DENVs). The team from both the ICGEB and Sun Pharma lay much emphasis on supporting any "holistic" medicine with the clinical trials of modern science, so that, as Dr Khanna said, such a drug could be prescribed by all doctors, not just AYUSH practitioners. Drugs under AYUSH, with no such clinical trials can only be prescribed by AYUSH doctors. ]]> <![CDATA[Piramal to acquire four brands from Pfizer ]]> https://biospectrumindia.com/news/95/7995/piramal-to-acquire-four-brands-from-pfizer-.html https://biospectrumindia.com/news/95/7995/piramal-to-acquire-four-brands-from-pfizer-.html Mon, 16 May 2016 11:50:17 +0530 Piramal Enterprises' Consumer Products Division has entered into an agreement to acquire four brands from Pfizer Limited for a consideration of Rs 110 crores. The acquisition includes brands namely: Ferradol, Neko, Sloan's and Waterbury's Compound. Additionally the agreement also includes the trademark rights for Ferradol and Waterbury's Compound in Bangladesh and Sri Lanka. These brands hold a rich legacy and have a high consumer pull and are available in India for the past 30+ years â€¢ Ferradol launched in 1982, is a leading nutritional supplement for children and adults. â€¢ Neko launched in 1967, is a medicated soap indicated for body odor and minor skin infections. â€¢ Sloan's launched in 1982, is muscular pain reliever that is available in balm and liniment forms. â€¢ Waterbury's Compound launched in 1970, is used for building Cough and Cold immunity. These products currently operate in a market which is currently estimated at Rs 7000 Cr. Completion of the deal is subject to certain conditions including regulatory approvals. Ms Nandini Piramal, executive director, Piramal Enterprises said, "Our aim is to be a significant player in every business under the Healthcare vertical of Piramal Enterprises Limited. We are one of the large Custom Manufacturing Companies and have manufacturing bases in North America, European Union and Asia. Our Critical Care business is the third largest player in the Global Inhalation Anesthesia market. The Consumer Products Division of the company currently ranks 7th in India; but we aim to be a Top 3 player in the OTC market by 2020. Acquisition is one of the important routes to help us achieve our goal and in the last 6 months we have done two acquisitions in the Consumer Products business. The first one was the Littles baby care range of brands and second was the gastro-intestinal portfolio of brands from MSD. We believe these brands from Pfizer will fit our portfolio and also strategically help us move closer towards our stated objective. The combination of growing our existing core brands and strategically acquiring accretive brands has helped us create a unique business which has a powerful portfolio of OTC brands in India." Mr Kedar Rajadnye, COO - Consumer Products Division, Piramal Enterprises said, "Our success and expertise in building and acquiring brands across categories is our strength. Most of the brands in our portfolio viz Saridon, Ipill, Lacto Calamine, Tetmosol and Caladryl have strong consumer franchise and are leading players in their respective categories. We currently have 6 of our brands in the top 100 OTC brands of India. We have proven strength in marketing and also in chemist distribution where we have a strong footprint which covers all the 20,000 population towns across the country. We expect these brands to leverage the strong sales and distribution capability that we have built over the years and help us improve our profitability margins as there will be higher fixed cost absorption. These four powerful heritage brands have a huge potential to become power brands in their respective categories." ]]> <![CDATA[Sanofi files for Hart-Scott-Rodino notification regarding proposed acquisition of Medivation]]> https://biospectrumindia.com/news/95/4207/sanofi-files-for-hart-scott-rodino-notification-regarding-proposed-acquisition-of-medivation.html https://biospectrumindia.com/news/95/4207/sanofi-files-for-hart-scott-rodino-notification-regarding-proposed-acquisition-of-medivation.html Fri, 13 May 2016 16:38:22 +0530 Sanofi announced that it has filed for premerger notification under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (HSR) with the US Department of Justice Antitrust Division and the Federal Trade Commission regarding its intention to acquire Medivation. As announced on April 28, 2016, Sanofi proposed to acquire Medivation for $52.50 per share, representing an all-cash transaction valued at approximately $9.3 billion. ]]> <![CDATA[Veterinary medicine looking increasingly to human drugs to supplement treatment pipelines ]]> https://biospectrumindia.com/features/95/8322/veterinary-medicine-looking-increasingly-to-human-drugs-to-supplement-treatment-pipelines-.html https://biospectrumindia.com/features/95/8322/veterinary-medicine-looking-increasingly-to-human-drugs-to-supplement-treatment-pipelines-.html Fri, 13 May 2016 16:37:54 +0530 Significant unmet needs within veterinary care, including a lack of drugs for senior animals, underdeveloped research in areas such as veterinary oncology, and a scarcity of novel drugs, diagnostic aids, treatment monitoring, and vaccines, are driving veterinarians to treat animals such as dogs, cats and horses by prescribing drugs intended for human use, according to business intelligence provider GBI Research. The company's latest report states that the most significant drivers of Extralabel Drug Use (ELDU) in animals are financial. Unlike the human drugs market, veterinary clinics are involved not only in diagnosis and treatment, but also have the right to dispense pet medications. Consumers cannot purchase the prescribed medications from a pharmacy of their choice, where there would be access to low-priced generic drugs, and human treatments may be a viable alternative. Ms Deekshita Allavarapu, Analyst for GBI Research, says: "A blockbuster drug in human health generates revenues in excess of $1 billion, whereas the animal health market's highest selling drugs achieve $50-100 million, with around 85% of animal sales reaching less than $1 million. In this way, many manufacturers of veterinary drugs are looking for products already licensed for human use to fill their pipelines." Despite these drivers, there are safety, legal, ethical, and health issues associated with ELDU in animals. For instance, prescribing a human drug for veterinary use has its own risks. Mammalian species share many basic similarities in terms of responses to drugs, but there are differences seen at the cellular level, meaning responses may differ. Another possibility might be that a human drug is prescribed despite the presence of a veterinary-approved alternative due to affordability issues, meaning a veterinarian could face legal issues. Ms Allavarapu concludes: "Despite such problems, the intersection between human and veterinary medicine is a very important and emerging area that GBI Research believes will receive more focus in the years to come. For example, specially designed clinical trials are currently being run in which pets can be enrolled alongside human patients." ]]> <![CDATA[Disease-modifying drugs to propel Huntington's Disease market to $2.6 bn by 2024]]> https://biospectrumindia.com/news/95/8408/disease-modifying-drugs-to-propel-huntingtons-disease-market-to-2-6-bn-by-2024.html https://biospectrumindia.com/news/95/8408/disease-modifying-drugs-to-propel-huntingtons-disease-market-to-2-6-bn-by-2024.html Thu, 12 May 2016 17:19:03 +0530 The company's latest report states that the main driver of this extensive growth, which will occur across the seven major markets (7MM) of the US, France, Germany, Italy, Spain, the UK, and Japan, will be the launch of efficacious disease-modifying drugs, Raptor's RP103 and Prana Biotechnology's PBT2. Other drivers include the anticipated launch of enhanced symptomatic treatments, potential patient assistance programs which will reimburse expensive therapies, and an increase in the treatment rate of Huntington's disease patients. Ms Rebecca Robbins, GlobalData's Analyst covering Neurology and Ophthalmology, explains: "The scope for improvement in the Huntington's disease space is vast, with the greatest unmet need being the development of a disease-modifying drug that will slow or halt the progression of the disease, or prevent its development. In this way, the launch of such a drug would be a game-changer. "Currently, Raptor's RP103 is positioned to be the first potential disease-modifying drug to reach the market, giving it an important advantage over other disease-modifying drugs in the late-stage pipeline. Its main competitor will be Prana Biotechnology's PBT2, which is the only late-stage drug in the pipeline that is aiming to demonstrate an improvement in the cognitive deficits associated with the disease in clinical trials." Of the 7MM, PBT2 and RP103 are expected to be launched in all but Japan by 2024, with Japan seeing the smallest market expansion of all the countries, rising from $0.6 million in 2014 to $1.5 million by 2024, at a CAGR of 10%. This is still very robust growth, however, and can be attributed primarily to the launch of Teva's SD-809 and pridopidine, both symptom-alleviating drugs. SD-809 is anticipated to launch in Japan in 2020, with sales in this market forecast to be worth $1.1 million in 2024. Ms Robbins concludes: "The Huntington's disease pipeline will see exciting new developments over the next decade as disease-modifying drugs transform the market landscape. With ongoing research helping to further understand its pathogenesis, there are increasingly significant opportunities for developers to cultivate new drugs that may have differing modes of action from those already in the pipeline." ]]> <![CDATA[WHO: Address worsening urban air quality as a priority]]> https://biospectrumindia.com/news/95/3332/who-address-worsening-urban-air-quality-as-a-priority.html https://biospectrumindia.com/news/95/3332/who-address-worsening-urban-air-quality-as-a-priority.html Thu, 12 May 2016 17:18:21 +0530 Improving air quality must be a top health and development priority in countries of WHO South-East Asia Region as increasing air pollution levels are putting the health of billions of people at risk, said Dr Poonam Khetrapal Singh, WHO Regional Director for South-East Asia, in a WHO press release. She added, "More and more cities are now measuring air quality levels, which in itself is an indication that governments are recognizing air pollution as a problem. Monitoring air quality is a critical step for taking corrective action. Nine of the 11 countries in the Region have accessible data on air quality in the global report, with India having data from 122 cities." There is an overwhelming evidence of the impact of air pollution on stroke, heart disease, lung cancer, and chronic and acute respiratory diseases. Globally, in 2012 air pollution in urban areas is estimated to have caused 3.7 million deaths with more than one-third reported from the South-East Asia Region. Though awareness is rising, there is an urgent need to address the problem and implement evidence-based interventions. Transportation, power plants, biomass burning and ambient dust are major contributors to particulate air pollution. "In an urban setting, vehicular emissions are an important consideration, particularly with populations living in close proximity to roads. The problem of air pollution can only be addressed through multi-sectoral cooperation. Increasing use of clean energy such as LPG, renewable power sources like solar and wind, and prioritizing public transportation, walking and cycling amenities in cities are among a number of affordable strategies that can be adopted," opined Dr Poonam. The energy, transport, environmental and health sectors need to intensify their work together to prevent further impact, she held. WHO also said in a press release that it is committed to enhancing the global response to adverse health effects of air pollution with a coordinated set of actions at global, regional, national and city levels to change the trajectory of adverse effects of air pollution on health. ]]> <![CDATA[Indonesia's pharma market to touch $12.6 bn by 2020]]> https://biospectrumindia.com/features/95/8287/indonesias-pharma-market-to-touch-12-6-bn-by-2020.html https://biospectrumindia.com/features/95/8287/indonesias-pharma-market-to-touch-12-6-bn-by-2020.html Wed, 11 May 2016 14:40:07 +0530 The pharmaceutical market in Indonesia more than doubled from just under $3 billion in 2008 to reach approximately $7 billion in 2015 and is anticipated to increase further to $12.6 billion by 2020, driven primarily by the Indonesian government's economic and healthcare initiatives, according to research and consulting firm GlobalData. The company's latest report states that Indonesia's pharmaceutical sector will be boosted by the establishment of a universal healthcare scheme, known as the Jaminan Kesehatan Nasional. This was launched in January 2014 with the aim of providing health insurance to 250 million Indonesian citizens by 2019, which would make it the world's largest social health insurance. Mr Adam Dion, GlobalData's Senior Industry Analyst, says new economic policy packages, the high prevalence of infectious diseases, widespread generic drug supply, increasing affordability of healthcare products and the large over-the-counter medicines market will also help to drive growth in Indonesia's pharmaceutical sector. He explains: "The government implemented two economic policy packages in 2015, as GDP growth slowed and inflation increased. These policies mainly focus on raising investment in Indonesia and offering more industrial facilities to attract the investors. "As a consequence of high and consistent economic growth and burgeoning job opportunities, purchasing power has risen and demand for high-quality healthcare services has increased thanks to greater affordability and improved general health awareness. This will positively affect the growth of the Indonesian pharmaceutical market." Despite the overall positive trend, there are a number of factors limiting the expansion of Indonesia's healthcare industry, including the imposition of an Import Tax in 2010, a high level of counterfeit medicines, periodic price cuts to branded generics, and limited access to healthcare facilities for the rural population. Mr Dion continues: "Indonesia's pharmaceutical production plants are concentrated around Jakarta and Java, resulting in wide geographical discrepancies. In remote areas, many health centers and pharmacies are facing drug supply shortages due to insufficient production by manufacturers and a weak distribution system. "Furthermore, the high cost of branded medicines combined with a lack of public reimbursement for expensive and novel drug therapies limits access to efficient medicines. However, this offers a significant opportunity to generic players." ]]> <![CDATA[Lilly's Taltz could achieve blockbuster status in plaque psoriasis market]]> https://biospectrumindia.com/features/95/8001/lillys-taltz-could-achieve-blockbuster-status-in-plaque-psoriasis-market.html https://biospectrumindia.com/features/95/8001/lillys-taltz-could-achieve-blockbuster-status-in-plaque-psoriasis-market.html Wed, 11 May 2016 14:39:45 +0530 Eli Lilly's drug Taltz (ixekizumab), which was recently approved by the FDA for the treatment of adults with moderate-to-severe plaque psoriasis, is set to generate sales in excess of $1 billion in the US and Europe by 2022 due to its high clinical efficacy and good safety profile, according to an analyst with research and consulting firm GlobalData. As explored in GlobalData's recent report on the psoriasis market, the last six years have seen an influx of novel plaque psoriasis treatments outside mainstay anti-tumor necrosis factor (anti-TNF) therapies. Indeed, Novartis' Cosentyx, the first-to market interleukin-17A (IL-17A) inhibitor launched in 2015, has shown superior efficacy over other approved biologics, most notably the anti-TNF therapy Enbrel. Ms Alexandra Annis, GlobalData's Analyst covering Immunology, states: "Taltz has a shared mechanism of action with Cosentyx, and GlobalData anticipates it could be used ahead of a TNF inhibitor in biologic- and/or TNF-naÃ¯ve patients in the psoriasis space. Although it will be competing with Cosentyx, which has a significant first-to-market advantage, Taltz offers more convenient dosing. "The recommended dosing for Taltz is an initial 160 milligrams (mg) subcutaneous (SC) injection followed by an 80mg SC injection once every two weeks for 12 weeks, then 80mg every four weeks. In comparison, 300mg of SC Cosentyx is administered once a week, followed by 300mg every four weeks. In this way, Taltz will hold an edge in the anti-IL-17A market for psoriasis." In terms of competition GlobalData believes Taltz may face within the anti-IL17 class, Valeant's brodalumab may pose a threat, which is in pre-registration in the US and Europe for plaque psoriasis. Ms Annis concludes: "Although the drug has garnered safety concerns recently surrounding increased suicidal tendencies, brodalumab demonstrated clear superiority over Stelara in two head-to-head clinical trials, AMAGINE-2 and AMAGINE-3, and established itself as one of the most effective psoriasis drugs developed to date. "Despite the competition, GlobalData anticipates Taltz will become a blockbuster therapy due to its exceptionally high clinical efficacy." ]]> <![CDATA[Raj Ketkar named CEO of Arcadia Biosciences ]]> https://biospectrumindia.com/news/95/8436/raj-ketkar-named-ceo-of-arcadia-biosciences-.html https://biospectrumindia.com/news/95/8436/raj-ketkar-named-ceo-of-arcadia-biosciences-.html Wed, 11 May 2016 13:16:26 +0530 Arcadia Biosciences, an agricultural technology company that creates value for farmers while benefitting the environment and enhancing human health, announced today that Raj Ketkar will join the company as president and chief executive officer later this month. Mr Ketkar will replace Mr Roger Salameh, who has served as interim president and CEO since February. Mr Salameh will take on a new role as chief operating officer for the company, reporting to the CEO. Mr Ketkar brings nearly 35 years of agriculture and agricultural biotechnology business experience in the US and internationally. He spent more than 30 years in a variety of business, operations, and strategy roles for Monsanto Company, during which time he demonstrated successes in agricultural trait commercialization and growth around the globe. As managing director of the Mahyco-Monsanto joint venture in India, Mr Ketkar led the launch of Bt cotton, the country's first agricultural biotechnology product. In addition to his operations and trait commercialization experience, Mr Ketkar was also director of biotechnology strategy for Monsanto, where he led the development of the company's trait stacking technology. "With a number of breakthrough yield and stress traits in the late stages of development, Arcadia is at an exciting stage as a company," said Mr Ketkar. "I look forward to working with Roger and the team to build upon the company's achievements and improve the productivity and environmental sustainability of agriculture," he said. Ms Darby Shupp, chair of Arcadia's board of directors, remarked, "Raj has a well-established track record of building strategic partnerships and launching innovative agricultural technologies in multiple geographies. He is a proven leader with the unique set of skills and experience Arcadia needs to grow the business and commercialize the company's rich and robust trait pipeline." Ms Shupp added, "The Board would like to thank Roger for guiding the company through this important transition. We are fortunate that we will have the benefit of his continued contributions as chief operating officer of Arcadia. He, Raj, and the rest of the executive management team provide a solid foundation to help deliver on our shared vision for the company." ]]> <![CDATA[GE Healthcare partners with Heritage Valley Health System ]]> https://biospectrumindia.com/news/95/8329/ge-healthcare-partners-with-heritage-valley-health-system-.html https://biospectrumindia.com/news/95/8329/ge-healthcare-partners-with-heritage-valley-health-system-.html Wed, 11 May 2016 13:16:05 +0530 Heritage Valley Health System has announced an innovative, strategic alliance with GE Healthcare aimed to propel the health system's momentum of obtaining advanced medical equipment over the next 14 years. Heritage Valley Health System and GE Healthcare entered an agreement that initially includes new, state-of-the-art MRI and CT scanners for Heritage Valley Beaver and Heritage Valley Sewickley hospitals, new ultrasound equipment for Heritage Valley's hospital and medical neighborhood locations, upgrades to an existing GE CT scanner and the addition of nuclear imaging cameras. "By working with GE Healthcare as a strategic partner and initiating this long-term agreement, we are also able to mitigate the risk of technology obsolescence through routinely scheduled upgrades," said Dr John Luellen, vice president and chief operating / quality officer, Heritage Valley Health System. "This enables Heritage Valley to continually enhance our entire suite of imaging equipment, bringing the best technology available into our hospitals and community satellites." This alliance marks GE Healthcare's first Managed Equipment Service (MES) agreement in the US. The company anticipates that, with this announcement, it launches the first of many MES solutions across the country. "We have to be two steps ahead of innovation at all times - in technology, in expertise and in business," added Dr Luellen. "The MES agreement is a fixed capital expense that includes replacement and associated construction costs as well as ongoing staff training and service." "Through strategic models, such as MES structures, health systems like Heritage Valley prepare for the future with advanced imaging technologies and services," said Lee Cooper, President and CEO for GE Healthcare, U.S. and Canada. "As part of its agreement with GE Healthcare, Heritage Valley will move from a model of fluctuating capital expenditures to one that is more predictable and consistent over the 14-year commitment." ]]> <![CDATA[Generic erosion will reduce bipolar disorder market to $4.2 bn by 2024]]> https://biospectrumindia.com/features/95/5811/generic-erosion-will-reduce-bipolar-disorder-market-to-4-2-bn-by-2024.html https://biospectrumindia.com/features/95/5811/generic-erosion-will-reduce-bipolar-disorder-market-to-4-2-bn-by-2024.html Wed, 11 May 2016 10:37:44 +0530 The treatment market for bipolar disorder is set to decrease from $5.8 billion in 2014 to $4.2 billion by 2024, at a negative Compound Annual Growth Rate (CAGR) of 3.2%, as generic erosion continues to deter the development of novel therapies, according to research and consulting firm GlobalData. The company's latest report states that this decline, which will occur across the eight major markets (8MM) of the US, France, Germany, Italy, Spain, the UK, Japan and Canada, is going to be particularly steep between 2015 and 2017. The key event will be Otsuka's Abilify, which was the market-leading brand with 40% of sales across the 8MM in 2014, experiencing generic erosion in the US and five major European countries. Mr Thomas Parker, GlobalData's Senior Analyst covering Neurology and Ophthalmology, says: "Broadly speaking, the bipolar disorder market is widely genericized, and the patent expiration of Abilify is just one of many over the forecast period which will contribute to market stagnation. "In cost-conscious Western markets, discounted prices ensure that generic drugs are prescribed over branded equivalents. Opportunities for new and existing players are limited, as the uptake of novel pipeline products would be hindered by their premium price point. As a result, pharma companies have deprioritized bipolar disorder, meaning the late-stage pipeline is sparse." Despite such a bleak market outlook for bipolar treatment, there will be minor growth between 2020 and 2024, as the impact of generic erosion becomes saturated and the uptake of Abilify Maintena and Vraylar continues. Mr Parker continues: "For the market to be truly reinvigorated, the significant unmet needs of bipolar patients must be addressed. While the current treatment landscape includes a high number of established products that can effectively manage acute manic symptoms and reduce the frequency of relapses, the need remains for novel, effective treatment options for bipolar depression. "It is known that bipolar patients spend a significantly greater amount of time experiencing depression than mania, and there are currently only three approved drugs for this indication in the US, all of which are associated with unfavorable side effects. In this way, there are considerable opportunities for players looking to enter the future bipolar market." ]]> <![CDATA[Trio of exciting new drugs will ignite bladder cancer treatment market by 2017]]> https://biospectrumindia.com/features/95/8281/trio-of-exciting-new-drugs-will-ignite-bladder-cancer-treatment-market-by-2017.html https://biospectrumindia.com/features/95/8281/trio-of-exciting-new-drugs-will-ignite-bladder-cancer-treatment-market-by-2017.html Wed, 11 May 2016 10:36:38 +0530 The bladder cancer treatment market is set to boom from an estimated $177.1 million in 2015 to over $646.6 million in 2017, as the launch of three new therapies over the next two years revitalizes a largely stagnant arena, according to research and consulting firm GlobalData. The company's latest report states that the growth, which will occur across the 6 Major Markets (6MM) of the US, France, Germany, Italy, Spain and the UK, will be primarily down to the introduction of Telesta Therapeutics' MCNA and Roche's atezolizumab in 2016 and Bristol-Myers Squibb's Opdivoin 2017. Dr Cai Xuan, GlobalData's Analyst covering Oncology, says: "Atezolizumab is on track to launch in the bladder cancer therapeutics space towards the end of 2016, and is one of many pipeline immune checkpoint inhibitors. This class of drugs has ignited substantial enthusiasm in recent years, as it has already shown efficacy in other difficult-to-treat cancers, including metastatic melanoma and lung cancer. "As atezoliuzumab will be the first therapy of its kind to launch in this market, it will have a significant advantage, explaining why sales of the drug are forecast to account for 43.7% of the treatment space by 2017." GlobalData's report also states that despite the clear the potential that the bladder cancer treatment market presents, there are several barriers that may inhibit growth. Dr Xuan explains: "Firstly, the majority of bladder cancer patients are over the age of 60, meaning that if they live in the US, they are entitled to receive insurance coverage through Medicare, which may negotiate lower drug prices through the pending Medicare Prescription Drug Price Negotiation Act. "Secondly, reimbursement decision-makers, such as the UK's National Institute for Health and Care Excellence (NICE), have rejected drugs developed for bladder cancer in the past on the basis of cost effectiveness, which means new entrants will need to demonstrate significant improvements in efficacy over existing standards-of-care to substantiate any premium price claims." Of the drugs launching in the 6MM by 2017, GlobalData expects atezolizumab and Opdivo to meet reimbursement criteria, on the assumption that they will be viewed as effective and more tolerable alternatives for metastatic patients, compared with the current treatment options of GemCis and Javlor. ]]> <![CDATA[Takeda receives $38 million grant from Gates foundation ]]> https://biospectrumindia.com/news/95/8273/takeda-receives-38-million-grant-from-gates-foundation-.html https://biospectrumindia.com/news/95/8273/takeda-receives-38-million-grant-from-gates-foundation-.html Tue, 10 May 2016 11:35:49 +0530 Takeda Pharmaceutical has announced a partnership with the Bill & Melinda Gates Foundation to support global polio eradication in developing countries. With this funding, Takeda will develop, license and supply at least 50 million doses per year of Sabin-strain inactivated poliovirus vaccine (sIPV) to more than 70 developing countries. The vaccine will be manufactured at Takeda's facility in Hikari, Japan. This effort is aligned with Takeda's strategy to utilize innovation and partnerships to address critical unmet needs in global public health, and the Sustainable Development Goals adopted by the United Nations in September 2015. Mr Christophe Weber, president and CEO of Takeda said: "Takeda is honored to partner with the Gates Foundation to support the polio endgame. This represents a major commitment by a Japanese company to the health of children in developing countries around the world." Under the terms of the agreement, the Gates Foundation will provide a $38 million grant to Takeda to leverage its innovative vaccine manufacturing platform to develop and license a safe and effective Sabin-strain inactivated polio vaccine, and make at least 50 million doses per year available at an affordable price for developing countries receiving Gavi support. Gavi, the Vaccine Alliance, brings together public and private sectors with the shared goal of creating equal access to new and underused vaccines for children living in the world's poorest countries. Takeda's sIPV was originally licensed from the Japan Polio Research Institute, which is now a part of BIKEN. Mr Chris Elias, president, Global Development at the Bill & Melinda Gates Foundation stated, "In 2016, the world is closer than ever to eradicating polio. To eradicate polio we need to ensure every last child is protected from the disease - this partnership will help to ensure that the world has enough vaccine to get the job done and maintain a polio free world." "Takeda's polio program demonstrates our commitment to tackle the most important public health problems and promote access for the populations in greatest need, joining our programs in dengue, norovirus, and hand, foot and mouth disease," added Dr Rajeev Venkayya, president of Takeda's Vaccine Business Unit. "We're excited about this partnership with the Bill & Melinda Gates Foundation, and the potential to reach hundreds of millions of children around the globe as part of the final push to eradicate polio." ]]> <![CDATA[Weak pipeline means future Schizophrenia market may look to treatment for similar indications]]> https://biospectrumindia.com/features/95/8231/weak-pipeline-means-future-schizophrenia-market-may-look-to-treatment-for-similar-indications.html https://biospectrumindia.com/features/95/8231/weak-pipeline-means-future-schizophrenia-market-may-look-to-treatment-for-similar-indications.html Mon, 09 May 2016 16:23:31 +0530 Although the schizophrenia market is replete with unmet needs and its pipeline is paltry, the overall level of innovation for schizophrenia-related indications - which comprise depression, panic disorders, obsessive compulsive disorder, post-traumatic stress disorder and cognitive deficit - is far higher, and has the potential to provide some benefit to patients with schizophrenia, says business intelligence provider GBI Research. According to the company's latest report, the large population of schizophrenia patients in relation to its small pipeline of 134 products is indicative of a low level of investment in Research and Development (R&D), most likely due to a poor understanding of the underlying disease mechanisms. This acts as a strong barrier to the development of effective pharmaceutical products. Mr Dominic Trewartha, Managing Analyst for GBI Research, explains: "While current treatments offer some relief from symptoms such as hallucinations, they have not proven as effective for cognitive dysfunction and symptoms such as the inability to feel pleasure, and there are no disease-modifying drugs currently available. A number of combinations, such as the addition of adjuvant agents to antipsychotic medication, have been trialed, but they have had little impact." There are 360 products in the pipeline for conditions associated with schizophrenia, 60 of which are first-in-class, equating to 21% of products with a disclosed molecular target. Overall, while the proportion of first-in-class products is still low, there are more in the pipeline for schizophrenia-related indications, particularly depressions and cognitive deficit, than there are for schizophrenia itself, and these act across a far wider range of molecular targets. Mr Trewartha continues: "The range of innovation is relatively diverse in the pipelines for schizophrenia and related indications, with products acting on numerous novel molecular targets, including D-Amino Acid Oxidase, glutamate carboxypeptidase 2, and a number of probable G protein-coupled receptors. "It is likely that small molecules will remain clinically and commercially the most successful molecule types across many therapy areas and indications, being particularly relevant in the central nervous system (CNS) and schizophrenia, with only limited prospects that new product approvals could change the landscape. "Despite industry-wide trends towards a diversification in therapeutic molecule types, it is unlikely that this will be translated in CNS disorders and schizophrenia, due to the challenges of crossing the blood-brain barrier with larger and more complex molecular types." ]]> <![CDATA[Psoriasis market to more than double to $13.3 bn by 2024]]> https://biospectrumindia.com/features/95/6925/psoriasis-market-to-more-than-double-to-13-3-bn-by-2024.html https://biospectrumindia.com/features/95/6925/psoriasis-market-to-more-than-double-to-13-3-bn-by-2024.html Mon, 09 May 2016 16:19:00 +0530 The company's latest report states that this impressive growth will be driven by the launch of novel psoriasis products, uptake of biosimilars for currently marketed biologics, and the expansion of existing psoriasis therapies such as dimethyl fumarate from Germany into the US and major European markets. Dr Nikhilesh Sanyal, GlobalData's Analyst covering Immunology, explains: "Although the psoriasis market will be crowded, novel products such as Eli Lilly's anti-interleukin(IL)-17 drug, ixekizumab, and Johnson & Johnson's (J&J's) IL-23 inhibitor, guselkumab, are expected to achieve sales in excess of $1 billion each by the end of the forecast period, primarily due to their high clinical efficacy and safety profiles. "Other pipeline therapies with exceptional efficacy and safety credentials include Merck's tildrakizumab and AstraZeneca/Valeant's brodalumab, which will go a long way towards addressing the current need for therapies that can provide long-lasting results without side effects or an increased risk of comorbidities." Despite the clear advantages of these biologics, biosimilars will have a substantial presence within the market, due to their lower price. These treatments first emerged in 2014 after the loss of patent protection for J&J's Remicade (infliximab), and will continue to enter the market over forecast period. ]]> <![CDATA[Aurobindo Pharma receives FDA approval for Fenofibrate Tablets]]> https://biospectrumindia.com/news/95/6085/aurobindo-pharma-receives-fda-approval-for-fenofibrate-tablets.html https://biospectrumindia.com/news/95/6085/aurobindo-pharma-receives-fda-approval-for-fenofibrate-tablets.html Mon, 09 May 2016 11:16:27 +0530 Aurobindo Pharma Limited is pleased to announce that the company has received final approval from the US Food & Drug Administration (USFDA) to manufacture and market Fenofibrate Tablets, 48 mg and 145 mg. This product is expected to be launched in Q1 FY16-17. The approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) Tricor Tablets of AbbVie. Fenofibrate Tablet is used to treat high level of cholesterol and triglyceride in the blood. The approved product has an estimated market size of $412 million for the twelve months ending March 2016 according to IMS. ]]> <![CDATA[South Korean pharmaceutical market to grow slowly to $20.4 bn by 2020]]> https://biospectrumindia.com/features/95/7982/south-korean-pharmaceutical-market-to-grow-slowly-to-20-4-bn-by-2020.html https://biospectrumindia.com/features/95/7982/south-korean-pharmaceutical-market-to-grow-slowly-to-20-4-bn-by-2020.html Fri, 06 May 2016 16:42:54 +0530 The pharmaceutical market in South Korea will rise from approximately $18.6 billion in 2016 to $20.4 billion in 2020, representing Compound Annual Growth Rate (CAGR) of 2.4%, as the government increasingly focuses on generics in order to reduce healthcare expenditure, according to research and consultancy firm GlobalData. The company's latest report states that the country's generics market increased from $3.5 billion in 2008 to around $5.8 billion in 2015, growing at a CAGR of 7%, as the government has invested significantly in the generics market in recent years. Many novel drugs are set to lose their patents by 2020, meaning South Korea's generics market is expected to increase significantly. Mr Adam Dion, GlobalData's Senior Industry Analyst, says: "Overall market growth is expected to be influenced by burgeoning treatment populations and various government initiatives to encourage Research and Development (R&D) and sustain growth in the pharmaceutical industry, such as the Korean Small Business Innovation Research program." Other government initiatives will also aid businesses, such as lifting the ban on advertisements for medical services, which has enabled hospitals to hire advertising agencies to help them attract medical tourists. Mr Dion explains: "The Free Trade Agreement with the US, which began in March 2012, has had the effect of lowering tariffs for imports up to 80%, and nearly 95% of bilateral trade in consumer and industrial products has become duty-free for up to five years, making investment in the South Korean pharmaceutical industry easier for multinational companies." ]]> <![CDATA[Heart failure market to soar to $11.8 bn by 2025 ]]> https://biospectrumindia.com/features/95/7885/heart-failure-market-to-soar-to-11-8-bn-by-2025-.html https://biospectrumindia.com/features/95/7885/heart-failure-market-to-soar-to-11-8-bn-by-2025-.html Fri, 06 May 2016 16:42:13 +0530 The heart failure market is set to rise from around $3.2 billion in 2015 to $11.8 billion by 2025, representing a compound annual growth rate of 13.7%, according to research and consulting firm GlobalData. The company's latest report states that the key drivers of this substantial growth, which will occur across the seven major markets of the US, France, Germany, Italy, Spain, the UK, and Japan, will be the launch of Novartis' first-in-class drug, Entresto, and several acute heart failure add-on therapies, as well as an increase in the global prevalence of chronic heart failure. Dr Elizabeth Hamson, GlobalData's Analyst covering Cardiovascular and Metabolic Disorders, explains: "Novartis' Entresto is a first-in-class angiotensin receptor-neprilysin inhibitor (ARNi), which was launched in the US in 2015 and the five European countries in 2016, and is set for release in Japan by 2020. The drug has raised the benchmark for efficacious chronic heart failure therapy, although uptake has been slow. "Entresto has struggled to penetrate the chronic heart failure market, achieving dismal sales in the US since its launch in July 2015. GlobalData has identified high pricing and the general reluctance of cardiologists and physicians to adopt new therapies as the main barriers to the uptake of this drug. Despite this, it is expected that Entresto will begin to dominate the global heart failure space, particularly after its label expansion to heart failure with preserved ejection fraction, which is expected to occur in 2020, making it the strongest driver of market growth." Despite these significant advances for chronic heart failure, particularly with reduced ejection fraction, there have been no advances in the treatment of acute heart failure for the past two decades. However, two drugs currently undergoing Phase III evaluation for the treatment of acute heart failure have the potential to shape how this condition is treated. Dr Hamson continues: "Cardiorentis' ularitide and Novartis' serelaxin represent novel and exciting treatment options for acute heart failure. Both are recombinant forms of human proteins that are intended to be used on top of the current standard-of-care for acute heart failure, intravenous administered loop diuretics. "While the heart failure market will be invigorated by exciting new therapies over the forecast period, there will remain a major unmet need in the lack of a therapy which can reverse disease progression, rather than merely slowing it down. In this way, GlobalData believes that the scope for the development of even better and more exciting heart failure drugs is still very broad." ]]> <![CDATA[AstraZeneca, Foundation Medicine partner for Companion Diagnostic ]]> https://biospectrumindia.com/news/95/7018/astrazeneca-foundation-medicine-partner-for-companion-diagnostic-.html https://biospectrumindia.com/news/95/7018/astrazeneca-foundation-medicine-partner-for-companion-diagnostic-.html Fri, 06 May 2016 11:35:33 +0530 Foundation Medicine has announced an agreement with AstraZeneca to develop companion diagnostic assays to facilitate personalized medicine in oncology by identifying patients most likely to benefit from medicines within AstraZeneca's oncology pipeline. "We use companion diagnostics throughout clinical development to deliver innovative, targeted therapies to patients most likely to benefit," said Mr Ruth March, VP and head of Personalised Healthcare & Biomarkers at AstraZeneca. "The leading genomic profiling approach provided by Foundation Medicine can help ensure that patients are matched with therapies specifically targeted to the molecular drivers of their disease." As part of the collaboration agreement, AstraZeneca will utilize the Quality Systems Regulations (QSR)-compliant version of Foundation Medicine's comprehensive genomic profiling assay for solid tumors to enroll patients into clinical trials of therapies that target genomically driven mechanisms of disease. The companion diagnostic assay assesses multiple cancer-related genes as well as all four classes of genomic alterations, and will be developed in parallel with the clinical development of AstraZeneca medicines as part of a coordinated regulatory strategy. "We're delighted to expand our relationship with AstraZeneca to now include the development of companion diagnostics for their novel anti-cancer medicines," said Dr Steven J Kafka, president and chief operating officer for Foundation Medicine. He added, "This collaboration agreement, the fourth we have put in place with leading oncology companies, underscores the importance and potential of utilizing our rigorously validated, comprehensive profiling approach to make available to physicians an FDA-approved universal companion diagnostic solution for use with targeted medicines. We look forward to providing further updates as individual programs are initiated." ]]> <![CDATA[Global dermatology market set to reach $33.7 bn by 2022]]> https://biospectrumindia.com/features/95/7467/global-dermatology-market-set-to-reach-33-7-bn-by-2022.html https://biospectrumindia.com/features/95/7467/global-dermatology-market-set-to-reach-33-7-bn-by-2022.html Thu, 05 May 2016 17:11:00 +0530 The global dermatology market is set to experience strong growth from $20 billion in 2015 to $33.7 billion by 2022, representing a compound annual growth rate of 7.7%, says business intelligence provider GBI Research. According to the company's latest report, such an impressive rise will occur in spite of the patent expiries of many marketed monoclonal Antibodies (mAbs), which are unlikely to have a significant impact due to the practical and regulatory barriers faced by biosimilars. Growth will be driven by a strong late-stage pipeline, which includes several highly valuable targeted therapies, such as dupilumab, AN-2729, AMG-827 and ixekizumab. Ms Jennifer Goossens, Associate Analyst for GBI Research, states that: "There exists a significant unmet need for improved treatment options across dermatology indications, as physicians often cite poor efficacy, low patient compliance, and problematic safety profiles with the long-term use of many available treatments. This is especially true for patients with severe disease who rely on general immunosuppressive drugs. "There are currently a number of promising biologics in the pipeline for major skin disorders, including atopic dermatitis, acne vulgaris and rosacea, with 17 biologics in Phase III of development. This sizeable number suggests that they could have a considerable impact on treatment algorithms in the dermatology therapy area over the forecast period." In terms of specific products, Regeneron/Sanofi's dupilumab is the leading candidate to bring about a paradigm shift in the treatment moderate-to-severe atopic dermatitis. At the same time, the use of older systemic immunosuppressants in dermatology is likely to decrease once biologics for other key indications besides psoriasis enter the market from 2016. However, GBI Research believes the dermatology space is not likely to experience major shifts in terms of its big players by 2022. Ms Goossens concludes: "Key market players, namely Johnson & Johnson, AbbVie, Amgen, Novartis, and Roche, are expected to maintain their strong market shares throughout the forecast period, despite the fact that many of the approaching patent expiries - especially AbbVie's Humira and Johnson & Johnson's Remicade - will affect these companies directly." ]]> <![CDATA[Cellular immunotherapies represent long-term opportunity in Immuno-oncology space]]> https://biospectrumindia.com/features/95/7983/cellular-immunotherapies-represent-long-term-opportunity-in-immuno-oncology-space.html https://biospectrumindia.com/features/95/7983/cellular-immunotherapies-represent-long-term-opportunity-in-immuno-oncology-space.html Thu, 05 May 2016 17:09:59 +0530 While cellular immunotherapies, which encompass dendritic cell therapy and chimeric antigen receptor T-cell (CAR-T) therapy, are expected to show promising results in combination treatments in the next few years, they are unlikely to make a significant impact on the immuno-oncology market in the short term according to research and consulting firm GlobalData. The company's latest report states that recent advancements in the field of adoptive T-cell therapy have created much excitement surrounding CAR-T therapy as a potential cure for a variety of cancers. Indeed, the treatment hit the headlines in February 2016 after a preliminary clinical trial found that six out of the seven patients treated with CAR-T therapy were in complete remission. Dr Dan Roberts, GlobalData's Senior Analyst covering Oncology and Hematology, says: "Although the immuno-oncology space will be dominated by immune checkpoint inhibitors, which GlobalData forecasts to achieve sales of $24 billion by 2024, cellular immunotherapies and cancer vaccines will continue to be pursued, despite past failures." Novartis' CAR-T therapy, CTL019, will most likely be the first of its kind to be approved for patients with acute leukemia, giving it a head start in the segment. At present, Juno Therapeutics' JCAR-015, and Kite Pharma's KTL-019 are also at the forefront of CAR-T cell therapy development, and all three products have FDA breakthrough therapy designation. Dr Roberts continues: "Early studies of these drugs have demonstrated very impressive remission rates of up to 90%, although it is still too early to tell if these remissions will turn into cures. Downsides of CAR-T therapies include their association with severe immune toxicities, specifically cytokine release syndrome (CRS), which can be fatal. "Sales of cell therapies will be very low to 2024, especially when compared to checkpoint inhibitors. CAR-T cells, because of their high administration costs, are only primarily being developed in blood cancer populations, and GlobalData envisages that they will have overall low uptake and will be restricted to selected patients in large academic centers during the forecast period. "However, the research being conducted into these kind of immunotherapies is indicative of an innovative and changing immuno-oncology arena that offers considerable opportunities in the long term." ]]> <![CDATA[Scientists determine structure of Zika virus]]> https://biospectrumindia.com/news/95/8074/scientists-determine-structure-of-zika-virus.html https://biospectrumindia.com/news/95/8074/scientists-determine-structure-of-zika-virus.html Thu, 05 May 2016 13:17:00 +0530 A team led by Purdue University researchers has become the first to determine the structure of the Zika virus, which reveals insights critical to the development of effective antiviral treatments and vaccines. The team also identified regions within the Zika virus structure where it differs from other flaviviruses, the family of viruses to which Zika belongs that includes dengue, West Nile, yellow fever, Japanese encephalitis and tick-borne encephalitic viruses. A paper detailing the findings was published Thursday (March 31) in the journal Science and is available online. Any regions within the virus structure unique to Zika have the potential to explain differences in how a virus is transmitted and how it manifests as a disease, said Richard Kuhn, director of the Purdue Institute for Inflammation, Immunology and Infectious Diseases (PI4D) who led the research team with Michael Rossmann, Purdue's Hanley Distinguished Professor of Biological Sciences. "The structure of the virus provides a map that shows potential regions of the virus that could be targeted by a therapeutic treatment, used to create an effective vaccine or to improve our ability to diagnose and distinguish Zika infection from that of other related viruses," said Dr Kuhn, who also is head of Purdue's Department of Biological Sciences. "Determining the structure greatly advances our understanding of Zika - a virus about which little is known. It illuminates the most promising areas for further testing and research to combat infection." Zika virus transmission has been reported in 33 countries. Of the countries where Zika virus is circulating, 12 have reported an increased incidence of Guillain-BarrÃ© syndrome, and Brazil and French Polynesia have reported an increase in microcephaly, according to the WHO. In February, WHO declared the Zika virus to be "a public health emergency of international concern". "This breakthrough illustrates not only the importance of basic research to the betterment of human health, but also its nimbleness in quickly addressing a pressing global concern," said Purdue president Dr Mitch Daniels. "This talented team of researchers solved a very difficult puzzle in a remarkably short period of time, and have provided those working on developing vaccines and treatments to stop this virus a map to guide their way." Dr Rossmann and Dr Kuhn collaborated with Theodore Pierson, chief of the viral pathogenesis section of the Laboratory of Viral Diseases at the National Institutes of Health National Institute of Allergy and Infectious Diseases. Additional research team members include Purdue graduate student Devika Sirohi and postdoctoral research associates Zhenguo Chen, Lei Sun and Thomas Klose. The team's paper marks the first published success of the new Purdue Institute for Inflammation, Immunology and Infectious Diseases in Purdue's Discovery Park. The university's recently announced $250 million investment in the life sciences funded the purchase of advanced equipment that allowed the team to do in a couple of months what otherwise would have taken years, Dr Rossmann said. "We were able to determine through cryo-electron microscopy the virus structure at a resolution that previously would only have been possible through X-ray crystallography," he said. "Since the 1950s X-ray crystallography has been the standard method for determining the structure of viruses, but it requires a relatively large amount of virus, which isn't always available; it can be very difficult to do, especially for viruses like Zika that have a lipid membrane and don't organize accurately in a crystal; and it takes a long time. Now, we can do it through electron microscopy and view the virus in a more native state. This was unthinkable only a few years ago." The team studied a strain of Zika virus isolated from a patient infected during the French Polynesia epidemic and determined the structure to 3.8Ã…. At this near-atomic resolution key features of the virus structure can be seen and groups of atoms that form specific chemical entities, such as those that represent one of 20 naturally occurring amino acids, can be recognized, Rossmann said. The team found the structure to be very similar to that of other flaviviruses with an RNA genome surrounded by a lipid, or fatty, membrane inside an icosahedral protein shell. The strong similarity with other flaviviruses was not surprising and is perhaps reassuring in terms of vaccine development already underway, but the subtle structural differences are possibly the key, Dr Sirohi said. "Most viruses don't invade the nervous system or the developing fetus due to blood-brain and placental barriers, but the association with improper brain development in fetuses suggest Zika does," Dr Sirohi said. "It is not clear how Zika gains access to these cells and infects them, but these areas of structural difference may be involved. These unique areas may be crucial and warrant further investigation." The team found that all of the known flavivirus structures differ in the amino acids that surround a glycosylation site in the virus shell. The shell is made up of 180 copies of two different proteins. These, like all proteins, are long chains of amino acids folded into particular structures to create a protein molecule, Rossmann said.The glycosylation site where Zika virus differs from other flaviviruses protrudes from the surface of the virus. A carbohydrate molecule consisting of various sugars is attached to the viral protein surface at this site. In many other viruses it has been shown that as the virus projects a glycosylation site outward, an attachment receptor molecule on the surface of a human cell recognizes the sugars and binds to them, Dr Kuhn said. The virus is like a menacing stranger luring an unsuspecting victim with the offer of sweet candy. The human cell gladly reaches out for the treat and then is caught by the virus, which, once attached, may initiate infection of that cell. The glycosylation site and surrounding residues on Zika virus may also be involved in attachment to human cells, and the differences in the amino acids between different flaviviruses could signify differences in the kinds of molecules to which the virus can attach and the different human cells it can infect, Dr Rossmann said. "If this site functions as it does in dengue and is involved in attachment to human cells, it could be a good spot to target an antiviral compound," Dr Rossmann said. "If this is the case, perhaps an inhibitor could be designed to block this function and keep the virus from attaching to and infecting human cells." The team plans to pursue further testing to evaluate the different regions as targets for treatment and to develop potential therapeutic molecules, Dr Kuhn said. Dr Kuhn and Dr Rossmann have studied flaviviruses, the family of viruses to which Zika belongs, for more than 14 years. They were the first to map the structure of any flavivirus when they determined the dengue virus structure in 2002. In 2003 they were first to determine the structure of West Nile virus and now they are the first to do so with the Zika virus. ]]> <![CDATA[ICGEB, Sun ink pact to develop novel botanical drug for Dengue]]> https://biospectrumindia.com/news/95/8222/icgeb-sun-ink-pact-to-develop-novel-botanical-drug-for-dengue.html https://biospectrumindia.com/news/95/8222/icgeb-sun-ink-pact-to-develop-novel-botanical-drug-for-dengue.html Thu, 05 May 2016 10:36:56 +0530 International Centre for Genetic Engineering and Biotechnology (ICGEB) and Sun Pharma has signed an agreement to develop a novel botanical drug for treatment of dengue. Through this agreement, Sun Pharma commits development of Cissampelos pariera (Cipa), a botanical drug in collaboration with ICGEB. Through this agreement Sun Pharma will follow up on earlier pre-clinical collaboration between ICGEB and erstwhile Ranbaxy Laboratories. Sun Pharma will develop Cipa, a botanical drug following a drug registration process similar to a new chemical entity, consisting of all required in-vitro, in-vivo, pre-clinical and clinical studies meeting all regulatory standards of India and other regulatory agencies worldwide. According to Dr Dinakar M Salunke, director, International Centre for Genetic Engineering and Biotechnology , New Delhi, "Dengue, a mosquito-borne viral disease, poses a significant global public health risk. In tropical countries such as India where periodic dengue outbreaks can be correlated to the high prevalence of the mosquito vector, circulation of all four dengue viruses (DENVs) and the high population density, a drug for dengue is being increasingly recognized as an unmet public health need. Using the knowledge of traditional Indian medicine, we explored the indigenous herbal bio-resource to identify plants with pan-DENV inhibitory activity and identified CIPA as a safe, affordable and effective solution." Commenting on the company's partnership with ICGEB, Mr Kirti Ganorkar, senior vice president - Business Development & Portfolio Management, Sun Pharma said, "Dengue poses a significant global public health risk. In tropical countries like India where dengue outbreaks are significantly intense, a drug for dengue is recognised as an unmet public health need. Our partnership with ICGEB aims to develop Cipa as a safe, effective & affordable botanical drug for treatment of dengue." The terms of this agreement permits Sun Pharma's access to all the intellectual properties of this drug cross 17 countries. ICGEB will establish assay systems for development of Cipa for treatment of dengue infection for a pre-defined period of time. ICGEB will work exclusively with Sun Pharma for the development of this drug and clinical treatment strategies based on botanical and phyto-pharmaceuticals. Sun Pharma will pay royalties on sales post commercialisation. Other financial details of this agreement are confidential. ]]> <![CDATA[Exclusive: The Emerging New Wave of Theranostics]]> https://biospectrumindia.com/features/95/7262/exclusive-the-emerging-new-wave-of-theranostics.html https://biospectrumindia.com/features/95/7262/exclusive-the-emerging-new-wave-of-theranostics.html Wed, 04 May 2016 17:33:11 +0530 Imagine a very tiny capsule injected just below the skin of your arm. The capsule has a sensor capable of continuously measuring blood glucose levels and sends the information to your phone. Well, let's spice it up one level above the notch. Say, when the blood glucose level crosses its threshold, visualize the tiny little capsule releasing a dose of insulin in your blood stream. What this does is offer total freedom from regular needle pricks to measure blood sugar levels, and frees patients from the anxiety of taking the right insulin doses at the right time. Science Fiction Or Reality? Nope, this isn't something straight out of a Steven Spielberg's upcoming science fiction movie. This is Theranostics. A combination of diagnosis with therapy geared to revolutionize and disrupt the world of healthcare diagnostics. "The idea of Theranostics is old," says Dr Biplab Bose, an Associate Professor in the Department of Biosciences and Bioengineering at the Indian Institute of Technology (IIT), Guwahati. "However, the term was coined and gained popularity in recent times, thanks to the development of targeted drug-delivery, microfluidics, and nanotechnology. Both in India and abroad, extensive work is going on to use targeted nano-delivery systems for Theranostics. A prime focus on this is to create drug loaded nanoparticles that are suitable for both in-vivo imaging and as well as for targeted drug-delivery." Theranostics is the development and use of molecules for both diagnostics and therapeutic purposes, thereby providing Precision Medicine to patients - first in a clinical setting - for further understanding their diseases at molecular level, and then prescribing specific medicines. "For example," adds Dr Aman Sharma, the Founder of Pune-based start-up ExoCan Healthcare Technology which focuses on Oncodiagnostics and Therapeutics space. "Fever in different patients has similar symptoms like rise in the body temperature. However, it may occur due to different infections. Hence, detecting the infection, whether bacterial or virus, accurately and then providing specific therapy is addressed by Theranostics." The classic example is the use of Herceptin drug, a monoclonal antibody (mAb), against HER2 receptor, a specific protein expressed in almost 30% of breast cancer patients, to treat grade IV breast cancer patients. Theranostics approach would be to first identify HER2 over-expression in breast cancer patients by a diagnostic test, and then prescribe Herceptin as a drug to those who have this over-expression. In other words, Theranostics deliver customized treatment plan for patients, resulting in the availability of right drug, for the right patient, at the right time. "This combining of therapeutic and diagnostic modalities for personalized treatment of patients enhances drug efficacy and ensure patients safety," comments Dr Arumugam Muruganandam, MD & CSO of Bangalore-based Affigenix Biosolutions. "At present in India, patient-centered care which focuses on integrating two disciplines such as imaging and therapy for targeted drug-delivery at the site of action is in limited practice except in specialty hospitals for cancer and cardiovascular diseases (CVDs)." Indian Theranostics Scene Molecular theranostics is a major field that involves small biochemical moieties and biomacromolecules. India is yet to get its share of modern Theranostics field. There are a few start-up companies in India that are operating in the Theranostics and Personalized Medicine in general. "Theranostics and Personalized Medicine are very nascent sectors in India, as compared to the West, where personalised medical approaches have reached the clinic on a much larger scale," shares Dr Nilay Lakhkar, Founder & CEO, SynThera Biomedical, a start-up focusing on manufacturing and commercialization of biomaterials-based medical devices. The West may be early adopters of the evolving field of Theranostics in to their routine healthcare as it promotes safer and more efficacious pharmacotherapies to patients which is supported by patients, and encouraged by Insurance companies. "Whereas in India, we may gradually implement Theranostics across urban areas as it becomes affordable with appropriate testing systems, and expertise becomes available," remarks Dr Arumugam. Currently in the West, a severe disease like cancer is treated through precision medicine. For example, mutational typing of a cancer is first performed and the right therapy or drug is then prescribed based on the mutation. Nanoparticles made of Iron Oxide and Gold are increasingly adapted for both in vivo diagnosis and treating cancer. Here the diagnosis is performed by using existing clinical imaging techniques such as MRI (iron oxide) and X-ray or CT (Gold), where in following the intravenous injection, the nanoparticles accumulate in the tumor tissue to provide precise contrast thereby differentiating it from normal tissue. Considering the Indian population and its disease burden, Theranostics will eventually enter the Indian healthcare market in a big way in the next couple of years. "In the next 5 or 6 years, we would see some form of Theranostics in clinical use, particularly for solid tumours. I believe oncologists along with radiologists will probably be the first to introduce Theranostics in clinics," Dr Biplab predicts. However, the key question is whether India will be able to develop any such products indigenously? There are several lacking factors, points Dr Biplab. "Factors include lack of access to advanced instruments. India is lacking in the development of real-life microfluidic devices. However, Indian scientists have gained reputation in the field of nano-materials, including nano-drug delivery systems. Unfortunately, Indian pharma companies are slow to pick the thread from laboratories, and have not yet built upon the developments that have happened in our academic labs," he stresses. Also, the patients in India are not much clinically educated. "One of the fundamental issue is cost factor, and the absence of active clinical trials and proper counselling in Government hospitals; and lack of high throughput facilities are among many reasons which retard the development of opportunities in Theranostics in our country," highlights Dr Aman. The key areas of Theranostics have developed rapidly in the last few years including Photo-Immunotherapy (PIT), and nano-particle-based drug-delivery and imaging systems. "We may soon see some successful clinical trials in these two segments," reveals Dr Biplab. In a way, Personalized Medicine, Theranostics and Precision Medicine are all interlinked from the view point of treatment. Dr Arumugam explains, "It is all about the right drug, at the right time, for the right patients. Theranostics mainly refers to treatment strategy that combines therapeutics with diagnostics as one treatment unit. Personalized Medicine imply that drugs are being customized for each individual patient. In Precision Medicine, the dosing regimen is designed for patients based on drugs used, condition to be treated, genetics, environmental and lifestyle factors." Theranostics is important for both Personalized as well Precision Medicine, feels Dr Biplab. "I would say, it is important more for Precision Medicine. Take the example of a drug-delivery system that combines targeted drug-delivery and imaging of drug-delivery. Such drug-delivery system would allow the physician to deliver the drug to specific location as well as confirm it by imaging," he notes. The field of Theranostics is aided by Genomics, Proteomics, Organic or Inorganic Chemistry and Pharmacology. This makes it a broader field of interest, which cannot be catered by one researcher. "In a global perspective, active collaboration is very important for rational and innovative ideas to be seeded for true emergence of Theranostics. In Indian scenario, this is building up with many thematic inter-institutional and industry-academia proposals being funded by DBT, DST, ICMR and the likes. India ranks 3rd, with 1st and 2nd being China and USA, in research outcome in field of Nanotechnology, and a significant percent of publication is related to Nanotheranostics, funded mostly by DST's Nano Mission. India can be a global leader in the field, if collaboration between scientists in the above mentioned field is made stronger and sustained for a significant period of time," elaborates Dr Asifkhan Shanavas, Scientist, Institute of Nano Science and Technology (INST), Department of Science & Technology (DST), Government of India. Theranostics and Personalized Medicine is bridged by Pharmacogenomics, a field that studies the effect of genes on a person's response to drugs. This relatively new field combines Pharmacology and Genomics to develop effective, safe medications and doses that will be tailored to a person's genetic makeup. Personalized Medicine also takes all non-genetic and environmental factors in to account, including gender, age, diet, lifestyle, and even the intestinal microflora. Under this regime, the doctor will advise the patient to first take an in vitro diagnostic test or a single in vivo imaging protocol with the Theranostic agent to identify its efficiency to selectively accumulate and act in the pathological site. "According to the therapeutic outcome," explains Dr Asifkhan, "the physician decides the course of treatment for the patient. Furthermore, information from non-invasive imaging on the accumulation of nanomedicine formulations in potentially endangered healthy tissues such as heart and brain may help in excluding patients from further treatment. Consequently, combination of non-invasive imaging and disease-targeted drug delivery has significant potential for Personalized Nanomedicine-based chemotherapeutic interventions, to achieve delivery of the right drug, to the right location, in the right patient, at the right time." India's Opportunities At Hand Indian population is genetically very diverse. Scientifically, the West-built Theranostics tools may not work well for Indian population. Moreover, the mutations or genomic anomalies present in the Western population may not be harbored by the Indian patients due to different genetic makeup. Dr Aman explains, "Hence, development of indigenous pool of databases for Theranostics in various diseases is what we should start with. Three vital opportunities lie ahead for Theranostics in India. Firstly, disease-specific database (diabetes, heart disease, and cancer can be taken on priority) generation for personalized medicine by genotyping known mutations and validation of existing biomarkers. "Secondly, setting up minimal infrastructure for Theranostics tests in hospital level settings. Lastly, there must be patient counselling centres inside hospitals to make patients aware of their disease type. Economically, we are one of the biggest markets for Theranostics as mentioned earlier due to very divergent genetic makeup of the population. The Government can encourage public-private partnerships to promote Theranostics research in collaboration with pharma and biotechnology giants and improve infrastructure for such opportunities." For advanced diseases like cancer, the greater diversity in Indian population creates a window of opportunities for Theranostics or Precision Medicine. Dr Nilay opines that opportunities do exist for Indian companies to focus on cutting-edge Theranostics products and services with demands being driven by a growing, affluent, and knowledgeable patient pool. "However, the Indian market for Personalised Medicine is still very much a niche market focused on high-net-worth individuals (HNWIs), and upper middle-class consumers, since these therapies are highly expensive, and not yet easily scalable," he justifies. Dr Biplab believes that the first use of Theranostics would probably be in oncology clinics, where physicians would use targeted drug-delivery for solid tumours, and would be able to image or monitor such delivery in real-time. "Cancer is one of the leading causes of death in India, and its burden is increasing. Unlike many other disease, Precision Medicine is crucial in cancer. In near future, we may see several players in cancer Theranostics to enter the Indian market," adds Dr Biplab. India also has vast potential to exploit the Theranostics especially in nano Theranostics for patient care, provided the regulation and funding support system helps in the discovery by academic sector; development by biopharma sector; and adoption by healthcare providers for personalized treatment. "The middle income group population is growing in India, and medical tourism is on the rise, and my guess is that wealthy patients may be more willing to pay for personalized treatments," Dr Arumugam says. The sub-continent has significant population affected by both communicable (infectious disease of bacteria, fungi and virus) and non-communicable (cancer, myocardial infarction etc) diseases. Dr Asifkhan states that a significant percentage of these patients fail to respond to standard treatments due to emergence of drug resistance, which warrants newer effective strategies with rapid molecular diagnosis followed by rationally designed treatment. "Early detection and treatment is also vital to reduce such disease burden. Theranostic approach can have tremendous impact in this line along with appreciable reduction in cost involved due to the selective treatment protocol, i.e., Personalized Medicine," he highlights. Overcoming Obstacles Therapy and diagnosis go hand-in-hand, and both are expensive for a country like India, "Patient affordability is going to be a big challenge," stresses Dr Arumugam. "There is also perceived loss of opportunity by drug manufacturers for particular drug to be used by cherry-picking patients for treatments as it reduces the market potential of the drug. Educating doctors, patients, Insurers and regulators will be a challenge as Theranostics does not provide guaranteed outcome yet." Theranostics is closely related to patients. "Hence we should educate more patients about their disease types and right therapies, and how it can enhance lifesaving chances in case of a deadly disease," recommends Dr Aman. There is a need for the existence of certain private equity bodies, venture capitalists and Government schemes who can invest in high-risk upcoming areas like Theranostics. It also calls for setting up infrastructure to create biobanks, tissue banks, and minimal research setups in hospitals and medical colleges for creating our own indigenous databases. Dr Aman continues, "One of the most important shortcomings is the lack of good research in this area in our country. The Government should setup special grants schemes to promote biological research in Theranostics, and should also make a provision to bring research entities, medical colleges, and hospitals under one umbrella to make the best use of existing knowledge and resources." Just like drug development, work on Theranostics requires clarity on specific clinical requirements, understanding market dynamics, and the limitations of current technologies. "Therefore, successful development of a Theranostics requires active collaboration between academia, clinicians and the industry. In India such collaborations are rare, if not absent," Dr Biplab mentions. Dr Asifkhan also believes that cost will play a major role in translation of new Theranostic agents to clinics. He opines, "The foremost challenge is to develop these agents at lower costs, so that their industrial scalability will not have profound effect on its marketing costs, if they clear clinical trials. "Secondly, time is a crucial player in bringing some of the promising agents into market, as pre-clinical and clinical trial takes years to complete, demanding simple and efficient models such as organ-on-a-chip that provides quicker results on par to human trials. It is also important for Indian researchers to take up innovation as a key element to provide state-of-the-art Theranostic solutions." Strict Competition? Experts believe that the real completion is yet to begin perhaps due to great investments required in any Theranostics programs. One of the reasons is that it requires a huge sample base to start with, and compilation of information to reach statistical end-points. "Subsequently, that information is then put-up into R&D to design effective therapies for patients. The whole process is far more costly than just developing a common drug which would be used by bulk and unsorted population. Though, the field has far reaching implications for mankind, it is yet to take off to reach to its newer heights," says Dr Aman. Dr Arumugam also believes that though Theranostics has good potential it does not have any competitions at the moment. "In India, both doctors and patients may prefer to go with 'one-size-fits-all' approach, and continue with trial-and-error method for treating patients. Potential impact on revenues by the 'slice-and-dice' approach in selecting patients for personalized treatment will prevent wide acceptability by bigger hospital managements and biopharma companies, and may resist to change," he emphasizes. The Future While there are several advancements in molecular Theranostics to quote, the most attracting is in the field of Radiopharmaceuticals. They are successfully being used at Indian premier institutes such as Rajiv Gandhi Cancer Institute & Research Centre (RGCI&RC) among others. Dr Shailaditya Sengupta of Massachusetts Institute of Technology's (MIT) Brigham and Women's Hospital (BWH) developed nanoparticles which first delivers an anticancer drug specifically to tumour tissues, and if the tumour starts dying or regressing, it then starts lighting up the tumour in real-time. This is a major finding to first treat and then have a follow-up on the course of a disease. In longer terms, Theranostics would pave the way for a healthier world around us. Advancement in Nanotechnology, Biosensors, Bioelectronics, Pharmacogenetics, Cancer Immunotherapy, Biomarker Profiling, Companion Diagnostics, and the ability to combine therapeutic and diagnostic capabilities into one single agent (nanomaterials) have already started a ripple effect in healthcare. "The only limiting factor is going to be the affordability for personalized treatment," states Dr Arumugam. In the future, patients who suffer from chronic diseases will have a combination of wearable devices and implantable Theranostics. Dr Biplab observes, "These will monitor our critical health parameters in real-time and intervene at the right time. Considering the speed in development of micro-fabrication and micro-electronics, I believe, such devices will be in our homes within the next 10 years." Five years down the line, breakthroughs in Theranostics R&D may bring down treatment costs, and increase scale-up potential. "A focus on building strategic partnerships with global players in the pharma and diagnostics sectors may be the way forward for Indian companies in this space," suggests Dr Nilay. Through Theranostics, the treatment costs might go up initially, but a faster disease recovery would be ensured. Dr Aman voices, "Theranostics might improve patient survival chances especially in cancer and heart disease patients. In totality, a greater health, emotional, and life security is what the goal of Theranostics is." At the moment, India does not have a statistical data on molecular nature of disease(s) among the Indian population. Nevertheless, combining the three major diseases including diabetes, heart disease, and cancer, Theranostics market should value anywhere between US $300-500 billion in the next 5 years. In the coming years, a better collaboration between the fields of molecular or nano Theranostics and OMICs -- Genomics, Epigenomics, Transcriptomics, Proteomics and Metabolomics -- is expected to realize the dream of personalizing medical interventions, especially for evading disorders such as cancer. ]]> <![CDATA['Make in India' impact on Biosciences sector]]> https://biospectrumindia.com/news/95/8275/make-in-india-impact-on-biosciences-sector.html https://biospectrumindia.com/news/95/8275/make-in-india-impact-on-biosciences-sector.html Wed, 04 May 2016 12:00:00 +0530 In September 2014, Prime Minister Mr Narendra Modi launched 'Make in India' program, rolling out the red carpet to investors through a string of measures including easier norms and rules aimed at transforming India into a manufacturing hub. BioPharma and Medtech were amongst the 25 sectors that the government has identified that are covered under the Make in India plan. In the recent times, the campaign has created a lot of buzz, and has been a topic of discussion at various business meetings. But has there been any concrete steps to boost this campaign especially in the biopharma and medtech sector? BioSpectrum tries to find out: Impact of Make in India:There are some contradictory response to this. Though, some believe that the campaign has failed to meet any expectations, some say it is a move in the right direction. Speaking for the Medtech sector, Dr GSK Velu, founder and managing director, Trivitron Group of Companies, "There are some significant benefits to this move which will bring down the cost of medical equipment and devices by 30 to 50 per cent and also the uptime of equipment in tier 2/3/4 towns will improve due to easier availability of spare parts. Local production will also lead to additional employment generation, local R&D and local skill development programmes. Moreover, the PM's vision has already attracted some major MNC players are attracted to set up low cost manufacturing units in India to serve emerging market." The campaign has a positive impact on the generic pharmaceutical firms' feels, but for the biotech sector nothing significant, feels Mr N Venkat, co-founder, Vyome Biosciences. He said, "Nothing much is yet visible in the PM's Make in India Campaign for the Biosciences/Medtech Industry and the Players. The policies and investment thesis only talks about the increase in investment but concrete plans should be brought to the fore front. There has been a positive effect, though, for the Generic Pharmaceutical Players." Any positive outcomes?Definitely, with the Indian government supporting make in India all industries including healthcare are further sharpening their focus in India, said Ms Rekha Ranganathan- Global General Manager, Mobile Surgery & Head, Philips HIC. She added, "We expect even higher contribution from the region in the months to come. HIC, which aims at enhancing access to affordable healthcare in emerging markets, as well as across the globe is a key contributor to Philips globally. There has been a substantial increase in our healthcare footprint. Over the last few years, the facility has successfully launched 5 global products, doubled unit growth and filed multiple patents, making it a very important hub globally." Currently the government is willing to listen to the views of Indian Manufacturers in this segment and implement changes to the tariff structure and regulatory structure in the upcoming budget. "Indian Manufacturers are of the view Government should do away with 100% Customs duty exemption for all product categories as this has not benefited the end patients over the past two decades. As per the recent reports in the media, a Drug Eluting Stent which is being manufactured for Rs 5000 is being imported to India with around Rs 40,000 with nil Customs Duty and the end patient pays around Rs 1.5 lakhs for the same. Hence there is no rationale for Zero Customs duty for any Finished Goods imports and there should be at least 20% customs duty exemption between Finished Goods imports and Raw Materials/ Components import for ultimate manufacturing in the country," Dr Velu. "Nothing significant positive effects have been visible yet for the biotechnology industry, except for the momentum that Indian Pharmaceutical industry already has by being a global supplier of pharma generics. The trickledown effect might be visible some time later," said Mr N Venkat. Though at present, the effect might be negligible, the industry is optimistic that the future hold good promise for the campaign. Major announcements/ initiatives to promote the sectorsIndian medical devices industry is extremely import dependent almost 70 percent. To boost domestic manufacturing, the government has announced 100 percent FDI in medical devices. Speaking for the Biotech sector Mr N Venkat says that as of yet, there hasn't been any major announcement which complements or supports the campaign for the biotechnology industry's. It may be noted that to realize the vision of PM Modi's vision of 'Make in India', department of chemicals and fertilizers had set up three task force, among which one was on 'Promotion of Domestic Production of High End Medical Devices and Pharmaceutical Manufacturing Equipment'. The Task Force has given recommendations to address concerns and constraints facing the sector and suggested measures that would augment domestic production of medical devices. The Task Force has recommended measures to enhance policy and institutional support; suggested strengthening of infrastructural support; and, recommended fiscal and financial support to the sector. In addition, the Task Force has also recommended measures for creating an institutional set-up for efficacy & safety testing, promoting skill development aligned to the need of the industry, strengthening the R&D Capability of the sector, pricing strategy for the sector and conducive regulatory environment. Making India a manufacturing hubSo, how do we make India a manufacturing hub as envisioned by our PM, "By giving more significance to Indian companies than giving more importance to foreign companies at large can transform the country into a manufacturing hub, said Dr Velu. In order to establish a region as a manufacturing hub two main pre-requisites must be met talent and supplier base. "There is a very young, yet specialized population when it comes to R&D and engineering in India. We have a large base of this population and we need to invest in training this talent to become leaders in healthcare R&D and businesses. The supplier base in India is still at the infant stage in healthcare and we should focus on investing in increasing the supply base and ensure that we have global standards. Philips focus is to really develop and nurture this local base to further innovate and manufacture out of India," said Ms Ranganathan. Mr N Venkat suggests following measure can be taken to make the campaign a success and make India a biotechnology manufacturing hub viz, Creation of an ecosystem for development and capital availability for biosciences innovation and manufacturing units; Creation of optimal, effective and speedy regulatory system for approvals; Better export incentives for biotechnology industry with respect to technology licensing in addition to products' exports, to motivate novel biotechnology oriented companies to invest in and increase exports and Lucrative incentives for the global biotechnology players to set up their operations in India and collaborate with Indian biotechnology firms for joint product and technology development. Time has finally come to turn discussions to decisions. ]]> <![CDATA[Despite major patent expiries, hematological cancers market to exceed $70 bn by 2022]]> https://biospectrumindia.com/features/95/8280/despite-major-patent-expiries-hematological-cancers-market-to-exceed-70-bn-by-2022.html https://biospectrumindia.com/features/95/8280/despite-major-patent-expiries-hematological-cancers-market-to-exceed-70-bn-by-2022.html Tue, 03 May 2016 17:11:46 +0530 The market for hematological cancers, which covers leukemia, lymphoma and myeloma, is expected to more than double from $30.7 billion in 2015 to $70.1 billion by 2022, representing a compound annual growth rate of 12.5%, according to business intelligence provider GBI Research. The company's latest report states that this strong growth will occur in spite of a number of key patent expirations for drugs including Rituxan, Gleevec and Velcade, as new drugs hit the market and the prevalence of hematological cancers increases. Mr Yasser Mushtaq, Senior Analyst for GBI Research, says: "The significant revenue lost by targeted drugs such as Gleevec and Velcade will be counteracted by recently approved drugs and pipeline products. Keytruda (pembrolizumab), for example, which is already marketed for metastatic melanoma, is in Phase III development for multiple myeloma and refractory multiple myeloma. It is also in Phase II development for a number of lymphomas and will therefore contribute to market revenue over coming years. "A number of drugs currently not marketed will also develop into blockbuster drugs, including selinexor, venetoclax, KTEC-19, and polatuzumab vedotin. Venetoclax in particular is expected to be very lucrative, hitting sales of $3.5 billion in 2022, up from an estimated $155.2 million in 2016. It is a selective, orally administered, first-in-class small molecule therapy in development by AbbVie and Roche, and is indicative of a trend in the market towards expensive targeted therapies, including monoclonal antibodies (mAbs)." As the use of targeted therapies continues to generate revenue above that of non-specific chemotherapy classes of treatment, key companies investing in the hematological cancers pipeline and targeted therapies will drive the market substantially, according to GBI Research. Mr Mushtaq continues: "The major market players, including Celgene, Roche, AbbVie, Novartis and Johnson & Johnson, are expected to maintain their strong positions. Of these companies, AbbVie will display the strongest growth, driven by its acquisition of Pharmacyclics, which was already a strong performer in this disease cluster." ]]> <![CDATA[Sanofi offers to acquire Medivation for $9.3 bn]]> https://biospectrumindia.com/news/95/8274/sanofi-offers-to-acquire-medivation-for-9-3-bn.html https://biospectrumindia.com/news/95/8274/sanofi-offers-to-acquire-medivation-for-9-3-bn.html Tue, 03 May 2016 17:10:43 +0530 This would represent an all-cash transaction valued at approximately $9.3 billion. Combining Sanofi and Medivation represents a compelling strategic and financial opportunity to drive significant value for the respective companies' shareholders, employees, patients and caregivers. The proposed purchase price represents a premium of over 50 percent to Medivation's two-month volume weighted average price (VWAP) prior to there being takeover rumors. "Last November, Sanofi outlined our mid-term strategy which includes rebuilding our position in oncology, one of the largest and fastest growing therapeutic areas in the biopharmaceutical sector," said Sanofi Chief Executive Officer Dr Olivier Brandicourt. "With Medivation's best-in-class offerings in prostate cancer, we believe a combination would benefit patients and, at the same time, generate value for shareholders of both companies." Medivation has one marketed prostate cancer therapy, Xtandi, and two additional oncology assets in clinical development. Sanofi has a significant presence in prostate cancer and a strong heritage in oncology. Despite advances in cancer treatments there remains a significant unmet medical need for prostate cancer, which is the second most common cancer in men worldwide, behind lung cancer. Approximately one in seven men will be diagnosed with prostate cancer during their lifetime. The transaction would create a stronger company with a complementary range of offerings to treat prostate cancer across the continuum of care, from urologists to oncologists. Sanofi has a strong track record of successfully integrating acquired companies, particularly in specialty care. Medivation would benefit from Sanofi's global capabilities, significant resources, internal pipeline of assets and complementary product offerings. The proposed combination has an attractive financial rationale as it would be immediately accretive to earnings and would offer value creation opportunities for Sanofi shareholders. There can be no assurance that any transaction will result from this proposal. Sanofi is confident in its ability to close the proposed transaction and receive all necessary regulatory approvals. The transaction would not be contingent on any financing condition. The full text of Sanofi's April 28, 2016 letter to Medivation is below. David T. Hung, M.DPresident, Chief Executive Officer and Director, Medivation, Inc.525 Market Street, 36th floorSan Francisco, CA 94105 Paris, April 28, 2016 Dear David, It has been over a month since we first talked and I expressed my view that a combination would make strong strategic sense, and I said we were prepared to make a very attractive proposal. During our first call on March 25, you said that you were unwilling to meet, and in our subsequent conversation on April 3 you said that, after a review with your Board, there was no interest in discussing a transaction. Given your unwillingness to meet or to hear our proposal, we sent you a letter on Friday, April 15, setting forth a proposal (the "Proposal") to acquire Medivation for $52.50 per share in cash, representing a premium of over 50% to the two-month volume weighted average trading price (VWAP) prior to there being takeover rumors. We have not heard anything from you for almost two weeks, other than an acknowledgment of receipt of our letter. We do not understand the delay in responding to our letter. The price we put forth represents a very substantial premium, and it would be all cash without any financing condition. In these circumstances we believe it is appropriate to make this letter public, which we are doing today. As we previously discussed, since I joined Sanofi in April 2015, we have set a clear strategic roadmap for 2020 and oncology plays an important role as part of that plan. As we aim to further develop our capabilities in this important area, we believe that Medivation represents a very strong fit and, together with our own clinical pipeline and existing infrastructure, will play an important role in our long-term strategy in oncology. We are excited by the prospect of accelerating Medivation's growth by leveraging Sanofi's infrastructure and capabilities. We are convinced that Medivation's employees would find a very attractive environment within our Sanofi Genzyme specialty business unit and our R&D organization, giving them the opportunity to fully develop their skills and help bring new treatments to patients on a worldwide basis. We also strongly believe that Medivation shareholders would find our Proposal to be compelling. Working with our advisors, our team has reviewed your business based on publicly available information and our knowledge of the markets in which you compete to validate our views on value. Given the amount of work we have done to date, we are well-positioned to swiftly consummate a transaction that will be in the best interests of, and provide immediate and certain value for, your stockholders. Our Proposal is subject to satisfactory completion of confirmatory due diligence, negotiation and execution of a mutually acceptable definitive written agreements, and approval of Sanofi's Board of Directors. We are prepared to meet promptly so we can mutually work towards a transaction that benefits our respective stockholders. Sincerely,Olivier BrandicourtChief Executive Officer -- End of Letter -- ]]> <![CDATA[FDA approves breakthrough Parkinson's drug]]> https://biospectrumindia.com/news/95/7889/fda-approves-breakthrough-parkinsons-drug.html https://biospectrumindia.com/news/95/7889/fda-approves-breakthrough-parkinsons-drug.html Tue, 03 May 2016 11:14:42 +0530 ACADIA Pharmaceuticals has announced that the US Food and Drug Administration (FDA) has approved NUPLAZID (pimavanserin) for the treatment of hallucinations and delusions associated with Parkinson's disease psychosis. In 2014, the FDA designated NUPLAZID as a Breakthrough Therapy for this condition. "This approval of NUPLAZID represents a major paradigm shift in the treatment of Parkinson's disease psychosis," said Dr Michael S. Okun, Medical Director of The National Parkinson Foundation. "Through its novel and selective mechanism of action, NUPLAZID is a breakthrough treatment that works in a whole new way - treating hallucinations and delusions without blocking dopamine receptors and, therefore, not impairing motor function in Parkinson's psychosis patients." NUPLAZID is the first and only medicine to be approved by the FDA for this indication. NUPLAZID is also the only drug approved by the FDA that preferentially targets 5-HT2A receptors. These receptors are thought to play an important role in Parkinson's disease psychosis. The unique pharmacology of NUPLAZID establishes a new class of drug - selective serotonin inverse agonists (SSIA) - by not only preferentially targeting 5-HT2A receptors but also avoiding activity at dopamine and other receptors commonly targeted by antipsychotics. Typical Parkinson's disease therapy consists of drugs that stimulate dopamine to treat patients' motor symptoms such as tremor, muscle rigidity and difficulty with walking. NUPLAZID does not interfere with patients' dopaminergic therapy and therefore does not impair their motor function. "NUPLAZID represents a major medical advancement for patients with Parkinson's disease psychosis who suffer from hallucinations and delusions," said Mr Steve Davis, ACADIA's president and chief executive officer. "We are grateful to the many patients and investigators who participated in NUPLAZID's clinical studies. NUPLAZID represents the culmination of many years of work across our entire organization to bring this novel medicine, discovered by our scientists, to patients in need." ]]> <![CDATA[BMS, Merck in race to dominate head & neck cancer market]]> https://biospectrumindia.com/features/95/8171/bms-merck-in-race-to-dominate-head-neck-cancer-market.html https://biospectrumindia.com/features/95/8171/bms-merck-in-race-to-dominate-head-neck-cancer-market.html Mon, 02 May 2016 17:41:05 +0530 Bristol-Myers Squibb (BMS) and Merck & Co. are set to continue their strong rivalry in the head and neck cancer space, as their respective PD-1 inhibitory monoclonal antibodies, Opdivo and Keytruda, race to enter the market, according to an analyst with research and consulting firm GlobalData. Both drugs have shown promise in clinical trials, and are therefore set to make waves across the head and neck cancer market which, as stated in GlobalData's most recent Head and Neck Cancer report, will grow rapidly to more than $1.5 billion by 2024. Dr Amy Yip, GlobalData's Analyst covering Oncology & Hematology, says: "Recent trials evaluating Opdivo's efficacy in recurrent or metastatic head and neck squamous cell carcinoma, found that it resulted in a 30% reduction in the risk of death, and a significant improvement compared to the only targeted agent currently approved for the disease, Eli Lilly's Erbitux (cetuximab). "Keytruda, on the other hand, in a single-arm Phase Ib trial, was found to produce an overall response rate of 24.8%, including a complete response in one patient. This compares favourably with the 10-15% response rate commonly reported for Erbitux monotherapy. In this way, as both Opdivo and Keytruda have shown significant superiority over current standard treatments, their success could depend on how soon they are approved by the FDA." As the first to file, Keytruda could become the first checkpoint inhibitor to reach the market. However, a filing for Opdivo is expected to occur soon, and is likely to gain full FDA approval on the strength of BMS' Phase III data. Opdivo's recently-awarded breakthrough therapy designation for head and neck cancers should also expedite the FDA approval process. If both agents gain a second-line approval, it will be difficult to predict which of the two will garner the larger market share, and the implications for BMS and Merck could vary widely. Dr Yip explains: "Even in a decidedly niche indication such as head and neck cancer, there is a potential difference of hundreds of millions of dollars in sales at stake across therapy lines between the first-to-market product and the runner-up. GlobalData believes that the pressure on both companies is only going to rise while the race between BMS and Merck comes to a close." ]]> <![CDATA[Italy's pharma industry value to drop to $18.6 bn by 2020]]> https://biospectrumindia.com/features/95/8331/italys-pharma-industry-value-to-drop-to-18-6-bn-by-2020.html https://biospectrumindia.com/features/95/8331/italys-pharma-industry-value-to-drop-to-18-6-bn-by-2020.html Mon, 02 May 2016 17:40:15 +0530 The pharmaceutical industry in Italy is set to decline from $21.3 billion in 2016 to $18.6 billion by 2020, at a negative compound annual growth rate of 3.3%, primarily due to the country's struggling economy, according to research and consulting firm GlobalData. The company's latest report states that the strict pricing of drugs through negotiations and external and internal reference pricing is a barrier to the launch of innovative molecules, and that sales of generics and over-the-counter drugs will increase over the forecast period. Mr Adam Dion, GlobalData's Senior Industry Analyst, explains: "The pharmaceutical industry in Italy will face a number of challenges over the next few years. An increase in the Italian government's debt relative to GDP, and the country's poor growth record, will decrease cash flow in the country, meaning the industry will stagnate." The Italian economy is also vulnerable to fluctuations in the demand and supply of goods and services in other countries. The Eurozone crisis is likely to result in lower demand for Italian products from other European countries, reducing exports and engendering a hostile environment for innovation or investment. India and China also present a threat as they have an edge in the generics market, and may usurp sales away from Italy's domestic pharmaceutical space. Mr Dion concludes: "Despite the tough economic environment faced by those operating within the Italian pharmaceutical industry, GlobalData believes there will be a number of opportunities to counteract declining sales, including efficient patent policies, E-Health programs, and government reforms to reduce public debt. Indeed, more companies will be interested in research and development after the Italian Patent and Trademark Office has created efficient patent policies to protect them." ]]> <![CDATA[Dr Satyajit Mayor elected foreign associate of NAS]]> https://biospectrumindia.com/news/95/7597/dr-satyajit-mayor-elected-foreign-associate-of-nas.html https://biospectrumindia.com/news/95/7597/dr-satyajit-mayor-elected-foreign-associate-of-nas.html Mon, 02 May 2016 15:02:53 +0530 Prof. Satyajit Mayor, Director, National Centre for Biological Sciences (NCBS) and Institute for Stem Cell Biology and Regenerative Medicine (inStem), has been elected a Foreign Associate of the US National Academy of Sciences (NAS). An election to NAS is recognition of a scientist's distinguished and continuing achievements in research. With this announcement, Prof. Mayor joins the list of other illustrious NAS fellows from NCBS, former director of NCBS, late Prof. Obaid Siddiqi, former director and current DBT Secretary Prof. K. VijayRaghavan. "Satyajit Mayor's election to the US National Academy of Sciences is recognition of the extraordinary science that has come from his lab over the past couple of decades. His superb science has defined new directions in cell- biology and has been combined with leading an awesome team of imaging-scientists and technologists to make the National Centre for Biological Sciences one of the best places for microscopy research and training in the world. His passionate leadership as Director of NCBS and inStem has created a vibrant Bangalore BioCluster that everyone was once sceptical about and now people all over India and the world want to emulate. The US National Science Academy is very lucky to have him in the club. I am sure we will hear a lot more about Jitu's science and scientific-leadership in the coming years. India should also be proud of the election of Manindra Agarwal of IIT/Kanpur, one of our best mathematician-computer scientists." says Prof K. VijayRaghavan. Prof Mayor's research uses multi-disciplinary approach combining cell biology with physics and chemistry to understand the molecular mechanisms of endocytosis in metazoan cells and to study this phenomenon at many scales. At the molecular scale his group aims to uncover the molecular players in endocytic processes; at the mesoscopic scale research in his laboratory attempts to provide a physical description of cell membrane structure and organization process and its material properties; at the cellular scale the work is aimed at synthesising a role for endocytosis in cellular signalling and cell surface homeostasis; at the scale of the tissue the group wishes to determine how control of endocytosis impinges on many developmental programs in tissue morphogenesis. Professor Ronald Vale, University of California San Francisco (UCSF),USA, Howard Hughes MedicaI Investigator and Vice-Chair of the Department of Cellular and Molecular Pharmacology at UCSF, says, "Mayor has changed our view of the plasma membrane, the lipid-containing barrier that separate the inside of the cell from the exterior environment. He has pioneered new techniques that reveal an intriguing nanoscale organization of molecules in the plasma membrane and has discovered that this organization arises both from lipids as well as a cytoskeletal network of filaments that is actively reshaping the membrane. Mayor's work has important implication on how signals are transmitted from the outside of the cell to its interior, which has important implication on understanding various types of human disease." Prof Mayor is also the recipient of several national and international awards such as the Wellcome Trust International Senior Research Fellowship, Swarnajayanti Fellowship, Shanti Swarup Bhatnagar Award and the JC Bose Fellowship and Infosys Prize for Life Sciences (2012) and elected EMBO Fellow in 2013. "Surprised but very happy to be elected to the US National Academy of Sciences. It is indeed an honour. Of course this is acknowledgement of our collective work and not just mine. It is a recognition of the members of my laboratory past and present, and my close collaborators Madan, and Ram (Vishwakarma). I could not have achieved this without the involvement of all of these wonderful people. This is a recognition of what we have been able to do at NCBS and the tremendous facilities we have for the work we do." reacts Prof. Mayor. ]]> <![CDATA[Dr Harsh Vardhan inaugurates the Biotech Infrastructure Facility ]]> https://biospectrumindia.com/news/95/8262/dr-harsh-vardhan-inaugurates-the-biotech-infrastructure-facility-.html https://biospectrumindia.com/news/95/8262/dr-harsh-vardhan-inaugurates-the-biotech-infrastructure-facility-.html Mon, 02 May 2016 10:55:59 +0530 Union Minister for Science & Technology and Earth Sciences, Dr Harsh Vardhan inaugurated the Department of Biotechnology (DBT) funded Biotech Infrastructure Facility (BIF) at ICAR-National Research Centre on Mithun (ICAR-NRCM), Jharnapani, Medziphema, Nagaland. Mithun is a unique large semi-domesticated animal of the bovine family, endemic to the North-eastern States of India. The Minister remarked that as Mithun touches every Naga household economically, socially and emotionally, it could not only become the symbol of the Naga people but also exemplify India's unity in diversity by strengthening the bondage between different communities. Dr Harsh Vardhan acknowledged that ICAR-NRCM is the only institute of its kind in the world solely dedicated to the conservation, propagation and development of Mithun which itself is geographically limited to Arunachal Pradesh, Nagaland, Manipur and Mizoram. The ICAR-NRCM farm has established modern scientific facilities for the rearing of Mithun under a semi-intensive system that comprises of various farmer-friendly technologies developed by the institute namely feed block, mineral block, area specific mineral mixture and low-cost feed formulation using industrial by-products. Dr Harsh Vardhan, expressing strong conviction said that this BIF facility will prove beneficial for young researchers of the North-eastern region. During the interaction with scientific staff of the institute he emphasized at working on research projects that are beneficial for farmers and implementable at the grass-root level. The Minister also visited the DBT-funded Citrus Processing Plant of ICAR-Regional Centre for North Eastern Region. He opined that the facility could be proved beneficial for food processing viz. Citrus fruits, pine apple and others such fruits and will also encourage the young entrepreneurs of the region to adopt the food processing technology for commercial purposes. ]]> <![CDATA[Still challenging to build a Biotech enterprise in India: Dr Kiran Mazumdar]]> https://biospectrumindia.com/news/95/7304/still-challenging-to-build-a-biotech-enterprise-in-india-dr-kiran-mazumdar.html https://biospectrumindia.com/news/95/7304/still-challenging-to-build-a-biotech-enterprise-in-india-dr-kiran-mazumdar.html Fri, 29 Apr 2016 18:15:00 +0530 Titled 'Mythbreaker -- Kiran Mazumdar-Shaw and the Story of Indian Biotech', and authored by renowned Journalist Ms Seema Singh, the 336-page book chronicles the entire history of Biotechnology in India. The book has been published by HarperCollins Publishers and is priced at Rs 599. "This book has been written in such a way that," said Dr Kiran Mazumdar, "everyone one who reads it will find something that they can relate to, and something I'm sure every entrepreneur will relate to. Things haven't changed much in India ever since I became an entrepreneur and started Biocon. It is still very challenging to start and build a biotech company in this country. We have not really done justice to the business of science. This country needs to pay a lot more attention to the power of science and technology. This country has to enable biotechnology and the business of science which are unfortunately not enabled as yet. The ecosystem to build a business based on science and technology is still very challenging in the country." She says that when it comes to Biotech, it is not just about venture capitalist (VC) funding. "It is about the regulatory environment, policy enablement and lots of other things which have not been done in our country for this sector. I have spent the last 38 years trying to build this business to bring it to this level, which is Asia's largest biotech enterprise today," she commented. Recalling her entrepreneurial experience since the inception of Biocon in the 70s, Dr Kiran added, "The crux of the matter is it's been a very hard and tough journey. I take on a battle everyday trying to solve some challenge. I know how tough it is for entrepreneurs to build this business. And biotech especially is very tough because there are so many unknowns about biotech from the point of policy and regulations." At the launch, it was recalled that Dr Kiran's mother, Mrs Yamini Mazumdar became an entrepreneur at the age of 68. Appreciating Ms Seema's efforts, Dr Kiran voiced, "When u chronicle the history, it's tough to make it readable. She (Seema) has chronicled the whole biotech history in this country and how this sector has been built over the years. She has done a great job." Dr Kiran added a piece of advice to Biotech entrepreneurs at the book launch. "Every entrepreneur should remember that it is not about the technology. You can have a not-so-great technology but if you can convert it and take it to the market you can do wonders. For me as an entrepreneur I'd say the biggest milestone was when I made an enzyme, and I wanted to export the product in the first year and I kept focused on that. You can have the best technology but get fixated on making it a commercial success," she emphasized. She feels that India's Life Sciences sector is not much focused on product development research. "We don't have enough research in product development. I think we are a services- and low-risk-oriented country. And we are basically happy with imitation. There are companies making millions by making generic drugs but won't invest a couple of crores in researching new drugs says it all," she pointed. Speaking about the book, Ms Seema added, "It's a journalistic effort which tries to provide a running account of one large company and not-so-large companies, officials and policies. ..In the end it has been a rewarding experience, and Kiran has been extremely patient and generous in sharing her experiences..." ]]> <![CDATA[Lupin Bolsters US brands portfolio with Methergine oral tablets]]> https://biospectrumindia.com/news/95/7935/lupin-bolsters-us-brands-portfolio-with-methergine-oral-tablets.html https://biospectrumindia.com/news/95/7935/lupin-bolsters-us-brands-portfolio-with-methergine-oral-tablets.html Fri, 29 Apr 2016 10:54:57 +0530 Pharma Major Lupin Limited and its US subsidiary, Lupin Pharmaceuticals, Inc. (collectively Lupin) have announced the re-introduction of Methergine (methylergonovine maleate) Oral Tablets 0.2mg for the prevention and management of postpartum hemorrhage (PPH). Methergine is said to be the only FDA-approved oral uterotonic and is a preferred oral agent in the management of PPH , according to guidelines issued by the American Congress of Obstetricians and Gynecologists (ACOG) . More than half of all maternal deaths occur within 24 hours of birth, most commonly from excessive bleeding , and rates of maternal morality continue to rise in the US where PPH is a leading cause of pregnancy complications . "The re-introduction of Methergine is a proud moment for Lupin, but also an important moment for expectant mothers across the country to feel confident in care options," said Mr Paul McGarty, president, Lupin Pharmaceuticals. "With Methergine, Lupin is making a significant investment to help improve the management of PPH, providing professional medical education, leveraging its specialized sales force to drive better awareness and access to care, and ensuring a more stable supply of this essential medicine." "Postpartum hemorrhage (PPH) is one of the most preventable causes of maternal mortality and it should be better managed in pursuit of improved patient care," said David B. Schwartz, MD, FACOG, independent OBGYN and ACOG fellow. "I commend Lupin for spotlighting this public health issue and making an investment in treatment, education and awareness of PPH." A semi-synthetic ergot alkaloid, Methergine is indicated for routine management of uterine atony, hemorrhage and subinvolution of the uterus following delivery of the placenta, and for control of uterine hemorrhage in the second stage of labor following delivery of the anterior shoulder. Methergine provides specific and rapid (onset of action under 10 minutes) uterotonic action on the smooth muscle of the uterus to increase contractions, resulting in restricting blood loss. The Methergine dosing schedule is one tablet (0.2 mg) three or four times daily in the puerperium for a maximum of one week. The most common adverse event is hypertension associated in several cases with seizure and/or headache. Methylergonovine maleate is available as an intramuscular injection or as an oral tablet; Lupin acquired oral methylergonovine maleate earlier this year. Postpartum hemorrhage (PPH) is often defined as blood loss in excess of 500 mL after vaginal delivery or 1000 mL after cesarean delivery. It is generally classified as primary - occurring within the first 24 hours of delivery - or secondary, up to 6-12 weeks postpartum. ]]> <![CDATA[Hilleman Laboratories advances two vaccines into clinical stage]]> https://biospectrumindia.com/news/95/8263/hilleman-laboratories-advances-two-vaccines-into-clinical-stage.html https://biospectrumindia.com/news/95/8263/hilleman-laboratories-advances-two-vaccines-into-clinical-stage.html Thu, 28 Apr 2016 12:39:47 +0530 Advancing closer to its vision of bridging the vaccination gap in developing nations, Hilleman Laboratories, a first-of-its-kind joint-venture between Merck Sharp & Dohme (MSD) and the Wellcome Trust, has announced the initiation of Phase I/II clinical trial of its innovative vaccine, an oral, lyophilized, heat-stable Rotavirus vaccine, against Rotavirus disease. After successful completion of the preclinical stage and obtaining regulatory clearance, Hilleman Laboratories has initiated a clinical study to establish proof-of-concept for its heat stable Rotavirus vaccine candidate. Hilleman Laboratories also obtained regulatory clearance for its innovative oral Cholera vaccine to conduct a Phase I/II clinical study that is intended to lead to an affordable vaccine against devastating Cholera infection. Commenting on these developments, Dr Davinder Gill, CEO, Hilleman Laboratories said, "These are exciting times at Hilleman Laboratories with several of our initiatives moving closer to meeting their objectives. There is a real need for safer and more effective vaccines to address the unmet needs of low-income nations. We have designed both Rotavirus and Cholera vaccine candidates keeping in view the socio-economic and demographic needs of developing nations. While on one hand, our heat-stable technology will offer longer stability to the Rotavirus vaccine in extreme climates, the next-generation oral Cholera vaccine will be affordable and easy-to-administer." Dr Gerd Zettlmeissl, Chairman of Board of Directors, Hilleman Laboratories said, "I congratulate the entire team at the Hilleman Laboratories on achieving this significant milestone. These developments further strengthen my belief in our vision of saving millions of lives lost due to preventable diseases in low income settings." In light of the World Immunization Week themed 'Close the Immunization Gap' by WHO, the new developments gives a massive impetus to the company's commitment towards realizing this goal. The clinical trials for both the vaccine candidates will be conducted at Bangladesh-based International Centre for Diarrheal Disease Research (ICDDR, B), an international health research organization. Dr John David Clemens, Executive Director, ICDDR, B, who is spearheading the trials said, "Increasing access to high impact vaccines will be the key to eradicate enteric diseases that are a leading cause of deaths in developing countries. Since beginning our collaboration with Hilleman Laboratories, we have been closely monitoring the development of both the Rotavirus and Cholera vaccines. We are now thrilled to get an opportunity to translate research into preventable treatment." Lauding the Indian government's efforts to reduce child mortality by including Rotavirus vaccines under the Universal Immunization Program, Dr Gill added, "This is a welcome step taken by the Government of India. However, high dependence on cold-chain for vaccine preservation, is a major gap in the delivery system. With our heat-stable Rotavirus vaccine, we aim to further support the government's efforts of expanding coverage and reducing child mortality." Rotavirus is the leading cause of severe diarrhea and death among children less than 5 years of age, 90% of these deaths occur in developing countries. According to the Ministry of Health and Family Welfare , nearly 80,000 to 100,000 children in India die due to Rotavirus diarrhea annually while nearly 900,000 children are admitted to hospitals with severe diarrhea. According to the World Health Organization, Cholera Vaccine production is low, with demands currently exceeding supply. Cholera is endemic in over 50 countries with estimated mortality of 100,000 - 120,000 deaths and a morbidity of 3.8 - 4.4 million annual cases attributed to this disease . In 2014 Hilleman Laboratories partnered with Gotovax AB of Sweden and Incepta Vaccines of Bangladesh for the development of an affordable Cholera vaccine. "In less than two years, with the strong assistance of our partners, we have successfully advanced our Cholera program from signing our partnership agreement to initiating clinical trials. This only enforces our aim to contribute in enhancing the supply of a much-needed vaccine across the world," added Dr Gill. ]]> <![CDATA[Opdivo to drive Renal Cell Carcinoma market to $3.6 bn by 2023]]> https://biospectrumindia.com/features/95/7201/opdivo-to-drive-renal-cell-carcinoma-market-to-3-6-bn-by-2023.html https://biospectrumindia.com/features/95/7201/opdivo-to-drive-renal-cell-carcinoma-market-to-3-6-bn-by-2023.html Wed, 27 Apr 2016 13:23:42 +0530 The market for renal cell carcinoma (RCC), a form of kidney cancer, is set to rise from $2.1 billion in 2013 to $3.6 billion by 2023, representing a compound annual growth rate of 5.6%, according to research and consulting firm GlobalData. The company's latest report states that this substantial growth, which will occur across the eight major markets (8MM) of the US, France, Germany, Italy, Spain, the UK, Japan, and China, will be driven by a number of factors including the rapid uptake of immune checkpoint inhibitors and combination regimens, and a considerable 63% increase in the incidence of RCC in the 8MM over the forecast period. Dr James Beggs, GlobalData's Analyst covering Oncology and Hematology, says: "Bristol-Myers Squibb's (BMS) immune checkpoint inhibitor Opdivo will be one of the most important drugs driving sales in RCC over the forecast period, approaching blockbuster status by 2023. "It will also be an important component in new combination therapies, which are set to be prevalent on the market as developers of programmed death protein 1 (PD-1) inhibitors rush to differentiate themselves in an increasingly competitive arena." Dr Maxime Bourgognon, GlobalData's Analyst covering Oncology and Hematology, explains: "Opdivo is currently being evaluated in a Phase III study in combination with Yervoy, another fairly new immunotherapy, as a first-line treatment. Interim data from the study shows that the combination increases overall survival in patients with untreated advanced melanoma beyond that of individual monotherapies, while maintaining a manageable safety profile, which puts it in a strong position to be commercially successful." While BMS is clearly ahead of competition with Opdivo already marketed in the US, other companies exploring combination therapies include Roche and Pfizer, which are trying to leverage the positions of Avastin and Inlyta in the RCC market. Dr Beggs concludes: "As these therapies are expected to show similar levels of efficacy in the rapidly changing RCC market, GlobalData believes their unique advantages in terms of safety profile, price, administration, physician familiarity, and marketing experience in RCC mean that all three combinations will achieve significant market share." ]]> <![CDATA[PD Hinduja Hospital holds infectious disease symposium ]]> https://biospectrumindia.com/news/95/7988/pd-hinduja-hospital-holds-infectious-disease-symposium-.html https://biospectrumindia.com/news/95/7988/pd-hinduja-hospital-holds-infectious-disease-symposium-.html Wed, 27 Apr 2016 11:04:09 +0530 PD Hinduja Hospital & Medical Research Centre in association with The Division of AIDS (NIAID, NIH) held a first-of-its-kind symposium on 'Advancing TB Research - An Exploration of Opportunities' in India. The symposium addressed the most pressing global and national health concern of Infectious diseases specifically Tuberculosis (TB), through innovative and multi-disciplinary solutions. India accounts for 35 percent of the total global burden of Neglected Tropical Diseases (NTDs) and as per World Health Organization (WHO) statistics for 2011, India has an estimated incidence figure of 2.2 million cases of TB out of a global incidence of 8.7 million cases. This public health issue is the world's largest epidemic and bears a disproportionately large burden of the world's tuberculosis rates. The workshop emphasized on the importance of research to curtail the current TB pandemic in India and globally. To address this growing burden of infectious diseases like TB and HIV, PD Hinduja Hospital & MRC will work together with The Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, U.S. Department of Health & Human Services. This will facilitate strengthening of clinical research capabilities in India through concerted training and research activities. This was signed by Mr Gautam Khanna, CEO, P.D. Hinduja Hospital & MRC and Dr Carl Dieffenbach, Director, The Division of AIDS (NIAID, NIH). Mr PP Hinduja, founder member, PD Hinduja Hospital & MRC said, "I would like to congratulate all the organizers of the workshop 'Advancing TB Research - an Exploration of Opportunities' and thank participants, including representatives of NIH and WHO for their presence and readiness to contribute to the successful outcomes of this workshop. TB is one of greatest India's health challenges, as India is home to more people ill with TB than any other country. Ending TB can be only achieved only through multidisciplinary approach and with greater collaboration within and across governments, and with partners form civil society, communities, researchers and the private sector. I am glad that the Hinduja Hospital is actively taking part in this collaboration and thus directly contributing to the campaign for a TB-Free India. " In accordance with the hospital's vision of institutionalizing health care by building bridges between India and the West, Ms. Vinoo Hinduja, Managing Trustee, P.D. Hinduja Hospital & Medical Research Centre said, "Our chairman, SP Hinduja first initiated global partnerships dedicated to improving healthcare and education almost 35 years ago. He advocated a mutual learning and sharing of knowledge to advance science in tropical infectious diseases. It is an honor to be associated with NIAID-NIH (US) in our expanded efforts to address India's greatest healthcare challenge in tackling infectious diseases and Tuberculosis. This workshop emphasized on global collaborations to ensure highest quality medical research in the space of infectious diseases as well as sharing latest advancement in research and clinical strategies for enhanced treatment outcomes." The symposium was addressed by local as well as international speakers in the field of infectious diseases. Key speakers from P.D. Hinduja Hospital included Dr. V. R. Joshi, Head of Research; Dr. Camilla Rodrigues, Consultant Microbiologist & Chairperson Infection Control Committee; Dr. Zarir Udwadia, Consultant Chest Physician; Dr. Rajeev Soman, Consultant Physician; Dr. Alan Almeida, Director - Clinical Research, Consultant Nephrologist & Transplant Physician; Dr. Tester Ashavaid, Director - Lab Research, Consultant Biochemist HOD, Lab Medicine and Dr. Sanjay Agarwala, Director - Professional Services, Chief of Surgery, Head- Orthopaedics & Traumatology. Some of the other noted Indian speakers at the symposium were Dr. Sunil Khaparde, Deputy DG, Central T. B. Division, Government of India; Dr. Soumya Swaminathan, Secretary, Department of Health Research, Director General Indian Council of Medical Research; Dr. Daksha Shah, Mumbai TB Officer. Additionally, other leading global scientists, researchers, clinicians and academicians at the symposium were Dr. Carl Dieffenbach, National Institute for Allergy & Infectious Diseases; Dr. Amita Gupta, Johns Hopkins University; Dr. Timothy Rodwell, FIND/University of California, San Diego; Dr. DJ Christopher, CMC Vellore; Dr. Christian Lienhardt, World Health Organization; Dr. Ramkrishna V., University of Texas health center; Dr. Vijaya Valluri, IMB Division, LEPRA India - BPHRC, Hyderabad; Dr. Jerrold Ellner, Boston University Medical Center; Michael Tartakovsky, National Institute of Allergy & Infectious Diseases; Dr. Steve Reed, Infectious Disease Research Institute; Dr. Salmaan Keshavjee, Harvard Medical School and many more. ]]> <![CDATA[Biocon Q4 profits at Rs 1382 million]]> https://biospectrumindia.com/news/95/8191/biocon-q4-profits-at-rs-1382-million.html https://biospectrumindia.com/news/95/8191/biocon-q4-profits-at-rs-1382-million.html Wed, 27 Apr 2016 10:24:49 +0530 Biocon Ltd has announced the following results for the quarter & year ended March 31, 2016: The Audited Standalone results for the Quarter ended March 31, 2016 The Company has posted a net profit of Rs. 1382 million for the quarter ended March 31, 2016 as compared to Rs. 478 million for the quarter ended March 31, 2015. Total Income has increased from Rs. 5973 million for the quarter ended March 31, 2015 to Rs. 7191 million for the quarter ended March 31, 2016. The Audited Standalone results for the Year ended March 31, 2016 The Company has posted a net profit of Rs. 8088 million for the year ended March 31, 2016 as compared to Rs. 3612 million for the year ended March 31, 2015. Total Income has increased from Rs. 23907 million for the year ended March 31, 2015 to Rs. 25077 million for the year ended March 31, 2016. The Consolidated Results are as follows: The Audited Consolidated results for the Quarter ended March 31, 2016 The Group has posted a net profit after taxes and minority interest of Rs. 3609 million for the Quarter ended March 31, 2016 as compared to Rs. 2015 million for the Quarter ended March 31, 2015. Total Income has increased from Rs. 8546 million for the Quarter ended March 31, 2015 to Rs. 10035 million for the Quarter ended March 31, 2016. The Audited Consolidated results for the Year ended March 31, 2016 The Group has posted a net profit after taxes and minority interest of Rs. 8961 million for the year ended March 31, 2016 as compared to Rs. 4974 million for the year ended March 31, 2015. Total Income has increased from Rs. 31429 million for the year ended March 31, 2015 to Rs. 35699 million for the year ended March 31, 2016. ]]> <![CDATA[Sun Pharma, ICMR ink deal to eradicate malaria]]> https://biospectrumindia.com/news/95/8014/sun-pharma-icmr-ink-deal-to-eradicate-malaria.html https://biospectrumindia.com/news/95/8014/sun-pharma-icmr-ink-deal-to-eradicate-malaria.html Tue, 26 Apr 2016 14:42:18 +0530 Bengaluru: In a bid to end the menace of malaria in the country, The Indian Council of Medical Research (ICMR) has inked a deal with Sun Pharma to jointly undertake malaria control and establish a national framework for elimination of malaria from the country. This first-of-its-kind public-private-partnership between ICMR, Ministry of Health and Family Welfare (MOHFW), Government of India (GoI), Government of Madhya Pradesh and Sun Pharma aims at setting-up management and technical committees to provide oversight for disease surveillance & elimination. The team will establish a malaria elimination demonstration project titled 'Malaria Free India', and the demonstration project will be launched in one of the most malaria endemic districts of Madhya Pradesh and implemented in a phased manner, beginning with Mandla district of Madhya Pradesh. "The first of its kind public-private-agreement between ICMR and Sun Pharma reiterates India's commitment to eliminate malaria," said Mr J P Nadda, Minister of Health and Family Welfare, "ICMR and Sun Pharma will aim to reduce the morbidity and mortality caused by malaria in this demonstration project as well as prevention of re-introduction of malaria. The lessons learned would be used for elimination of malaria from the country by the national program." Dr Soumya Swaminathan, director general, Indian Council of Medical Research, said, "I am pleased that ICMR is partnering with Sun Pharma in a malaria elimination demonstration project - a high priority for us. This project aims to demonstrate that it is feasible to eliminate malaria from a high endemic district, and will hopefully become a pathfinder for the rest of the country. It is also a unique model of collaboration between the central and state governments, a private pharma company and ICMR, and could pave the way for more private investment in public health." Sun Pharma's managing director, Mr Dilip Shanghvi, said, "Through this program we aim to achieve zero malaria incidences in more than 1,200 villages of Mandla district of Madhya Pradesh by FY21. The experience gained from Mandla project will guide the development of broader plans for malaria elimination in Madhya Pradesh as well as other high malaria endemic states in India." ]]> <![CDATA[Tentative FDA approval for Glenmark's new generic drug ]]> https://biospectrumindia.com/news/95/8238/tentative-fda-approval-for-glenmarks-new-generic-drug-.html https://biospectrumindia.com/news/95/8238/tentative-fda-approval-for-glenmarks-new-generic-drug-.html Tue, 26 Apr 2016 11:00:03 +0530 Glenmark Pharmaceuticals USA (Glenmark) has been granted tentative approval by the United States Food & Drug Administration (US FDA) for Norethindrone Acetate and Ethinyl Estradiol Tablets USP, 1 mg/0.01 mg, Ethinyl Estradiol Tablets USP, 0.01 mg and Ferrous Fumarate Tablets, 75 mg. The drug is the generic version of Lo Loestrin Fe (norethindrone acetate and ethinyl estradiol, ethinyl estradiol and ferrous fumarate) Tablets of Allergan Pharms Intl. Glenmark will market this product upon receiving final approval of its Norethindrone Acetate and Ethinyl Estradiol Tablets USP, 1 mg/0.01 mg, Ethinyl Estradiol Tablets USP, 0.01 mg and Ferrous Fumarate Tablets, 75 mg ANDA. The patent listed in the Orange Book for Lo Loestrin Fe (norethindrone acetate and ethinyl estradiol, ethinyl estradiol and ferrous fumarate) Tablets is scheduled to expire on February 2, 2029. According to IMS Health sales data for the 12 month period ending February 2016, the Lo Loestrin Fe market achieved annual sales of approximately $432.2 million. ]]> <![CDATA[Use of digital health apps to increase rates of TB diagnosis and provide faster treatment]]> https://biospectrumindia.com/news/95/1318/use-of-digital-health-apps-to-increase-rates-of-tb-diagnosis-and-provide-faster-treatment.html https://biospectrumindia.com/news/95/1318/use-of-digital-health-apps-to-increase-rates-of-tb-diagnosis-and-provide-faster-treatment.html Mon, 25 Apr 2016 17:00:36 +0530 The International Union Against TB and Lung Disease, TB Alert and Population Services International (PSI), presented four white papers on Tuberculosis and Non-Communicable Diseases at the Geneva Health Forum which took place from April 19th to April 21st this year. The first paper, presented by PSI, was on the investigation of community pharmacist knowledge and dispensing behaviours and their implications in diabetes and hypertension management. The pharmacist's active role in patient treatment and care was found to be significant and correlated with better, positive patient outcomes. In addition, the study revealed a need to enhance overall knowledge of community pharmacists on diabetes and hypertension, with an emphasis on knowledge of misconceptions and dispensing practices. The second paper discussed a project by TB alert called the 'Pratam Initiative', where the objective was to bring about active and sustained involvement of pharmacists and Rural Health Care Providers (RHCPs) in the Government's RNTCP. The focus was on the role that a pharmacist plays in early identification of TB in people showing TB symptoms and referring them to RNTCP facilities for testing and treatment. The project looked at rural, semi-urban and slum areas. Common patient perceptions toward NCDs such as diabetes and hypertension were examined in the third paper presentation by PSI. The major barriers to treatment were inability to afford treatment and lack of access which made patients consider the use of non-conventional medicines (such as herbal medication) over prescribed drugs to overcome these issues. The study discussed how such factors negatively affect a patient's likelihood to take preventive actions such as early screening and adopting healthy behaviour. The last paper presented by the International Union Against TB and Lung Disease focused on the introduction of two interoperable android apps designed for the rural healthcare providers (RHCPs) and lab technicians (LTs) at the TB microscopy centres. Encouraging findings of the study showed an increased number of people diagnosed, improvement in referrals, and an overall reduced delay in diagnosis and treatment initiation of TB patients through this innovative and affordable mHealth initiative. Eli Lilly has partnerships with the International Union Against TB and Lung Disease and with TB Alert for the Lilly MDR-TB Partnership and with Population Services International (PSI) for Project UDAY - a comprehensive Diabetes and Hypertension Prevention and Management Program in India, supported by an unrestricted grant from Eli Lilly and Company under the Lilly NCD Partnership. ]]> <![CDATA[One year on, health partners review Nepal quake response, call for scaling up emergency preparedness]]> https://biospectrumindia.com/news/95/6800/one-year-on-health-partners-review-nepal-quake-response-call-for-scaling-up-emergency-preparedness.html https://biospectrumindia.com/news/95/6800/one-year-on-health-partners-review-nepal-quake-response-call-for-scaling-up-emergency-preparedness.html Mon, 25 Apr 2016 14:02:48 +0530 As Nepal marks one year of the killer earthquake on 25 April, the health sector partners reviewed lessons learnt from the event and recommended strengthening and expanding emergency preparedness and response capacities beyond the national capital, and testing them periodically, to prepare better for future emergencies. "We must learn from the Nepal earthquake, just as we did from the Indian Ocean tsunami. Applying lessons learnt from such events can help strengthen our efforts for preventing emergencies from becoming disasters," Dr Poonam Khetrapal Singh, Regional Director for WHO South-East Asia, said. Dr Khetrapal Singh was addressing a two-day 'Lessons Learnt Conference: Health Sector Response to Nepal Earthquake 2015, organized by the Ministry of Health, Nepal, and WHO, here on 20-21 April. Priority lessons identified in the meeting would be consolidated into a road map for further action. The health sector response to the Nepal earthquake was rapid, well-coordinated among the health partners, and tailored to the needs of the affected population. "While acknowledging what was done right, we must also identify areas where we could have done better and explain the reasons behind these," the Regional Director said. Among the key lessons learnt highlighted at the conference were the need for extending emergency preparedness and response measures beyond the national capital, to the districts. As over 80% of health facilities in the affected districts were either damaged or destroyed in the earthquake last year, the injured had to be rushed to hospitals in Kathmandu, which remained functional as they had been retrofitted, their staff trained in mass casualty management and they had emergency plans in place that were immediately activated. "The preparations that were done in Kathmandu hospitals helped saved many lives. Similar preparations need to be put in place at all other levels too, so that in the event of an emergency, everyone throughout the health system is prepared and knows what to do. As health facilities are being reconstructed, there is an opportunity to build better, and put more risk reduction measures in place" Dr Khetrapal Singh said. Stronger policies will be needed for ensuring that disaster risk reduction measures are implemented and emergency preparedness and response capacities are built at all levels, with all cadres of health staff trained. Robust emergency response plans should be in place at all levels and should be tested periodically for their effectiveness. These plans should be all encompassing - from ensuring resilient and safe hospitals, to training health staff and effectively engaging communities, to minimize the health impact of any emergency. "Strengthening emergency preparedness and response capacity should be an ongoing process in Nepal and in all other countries. With WHO South-East Asia Region prone to natural calamities, the lessons learnt from the Nepal earthquake are important for the entire region to prepare better to respond to emergencies," Dr Khetrapal Singh said. WHO stands committed to continue to work with the Nepal government and partners for rebuilding a resilient health sector to save lives in any emergency. WHO's South-East Asia Region comprises the following 11 Member States: Bangladesh, Bhutan, Democratic People's Republic of Korea, India, Indonesia, Maldives, Myanmar, Nepal, Sri Lanka, Thailand and Timor-Leste. ]]> <![CDATA[PD Hinduja Hospital partners with The Division of AIDS to establish a center of excellence for infectious disease research ]]> https://biospectrumindia.com/news/95/6466/pd-hinduja-hospital-partners-with-the-division-of-aids-to-establish-a-center-of-excellence-for-infectious-disease-research-.html https://biospectrumindia.com/news/95/6466/pd-hinduja-hospital-partners-with-the-division-of-aids-to-establish-a-center-of-excellence-for-infectious-disease-research-.html Mon, 25 Apr 2016 10:57:59 +0530 P.D. Hinduja Hospital & Medical Research Centre signed a Letter of Intent (LOI) with The Division of AIDS, National Institute of Allergy and Infectious Diseases, National Institutes of Health, US Department of Health & Human Services with a pledge to address the growing burden of infectious diseases like TB and HIV. This LOI between the two entities will facilitate strengthening of clinical research capabilities in India through concerted training and research activities. Since its establishment in 1987, the Research Society at P.D. Hinduja Hospital & MRC has been enthusiastically supporting research in the hospital. While the hospital's research community has undertaken and processed close to 1,000 research projects, tuberculosis has been an extremely active research area. The Hinduja Research Society has generously supported research on TB over the last 20 years and helped catalyze change in the programmatic management of TB in India and particularly in Mumbai. With over 35 international research projects, the Hinduja Hospital Research team has had at least 10 international collaborations in the field of TB and the LOI with NIAID, NIH will only fortify this commitment in research for infectious diseases. Talking about the overall objective of this agreement, Ms Vinoo Hinduja, Managing Trustee, P.D. Hinduja Hospital & Medical Research Centre said, "This is a moment of pride for both Institutes NIH and us laying the foundation of partnering and gifting to the world a platform of US/INDO scientists working together to transform healthcare in six core disease areas - Cardiac Sciences, Neuroscience and Mental Health, Diabetes, Pulmonary Medicine, Oncology and Musculoskeletal/Trauma along with Infectious and chronic diseases. Our team's research work and globally recognised achievements in the field of TB, from research - based TB rapid diagnosis to successful treatment of MDR / XDR /TDR TB patients has proven the importance and connection between research and diagnosis. Now we are taking a step further to bring contributors to the subject of TB together under one roof along with The Division of AIDS (NIAID, NIH)." Mr P.P Hinduja, Founder Member , P.D. Hinduja Hospital & MRC said, "In the opening day of workshop "Advancing TB Research - an Exploration of Opportunities", I am congratulating organisers of the workshop and thanking participants, including representatives of NIH and WHO for their presence and readiness to contribute to the successful outcomes of this workshop. TB is one of greatest India's health challenges, as India is home to more people ill with TB than any other country. Ending TB can be only achieved only through multidisciplinary approach and with greater collaboration within and across governments, and with partners form civil society, communities, researchers and the private sector. I am glad that the Hinduja Hospital is actively taking part in this collaboration and thus directly contributing to the campaign for a TB-Free India. I am wishing the organisers and the participants of the workshop successful discussions. I believe that outcomes of the workshop will contribute to overcoming challenges and bringing down the cost of TB treatment in India and globally." Commenting on the partnership, Mr Gautam Khanna, CEO, PD Hinduja Hospital and Medical Research Centre said, "This is indeed a historic day for us at PD Hinduja Hospital and Medical Research Centre, as we initiate a promising start with The Division of AIDS (NIAID, NIH) for launching a Center of Excellence for Infectious disease research. PD Hinduja Hospital along with our dedicated teams of researchers, clinicians and management has played a vital role in Tuberculosis research and policy development in India." Under this LOI, a center of excellence linked to the hospital, Hinduja Institute for Medical Research and Training (HIMAT) will be established to address the issues of TB & HIV and maintenance of a clinical research site at HIMAT. The Division of AIDS, NIAID, NIH will assist in training and scientific exchanges for HIMAT affiliated researchers in NIH or NIH associated institutions. The LOI was signed by Mr. Gautam Khanna, CEO, P.D. Hinduja Hospital & MRC and Dr. Carl Dieffenbach, Director, The Division of AIDS (NIAID, NIH). ]]> <![CDATA[New threat against affordable medicines in trade negotiations with India, ASEAN]]> https://biospectrumindia.com/news/95/6883/new-threat-against-affordable-medicines-in-trade-negotiations-with-india-asean.html https://biospectrumindia.com/news/95/6883/new-threat-against-affordable-medicines-in-trade-negotiations-with-india-asean.html Fri, 22 Apr 2016 14:47:31 +0530 Access to affordable medicines could be severely restricted for millions of people around the world under the current proposals in the Regional Comprehensive Economic Partnership (RCEP) trade agreement, the international humanitarian medical organization MÃ©decins Sans FrontiÃ¨res (MSF) warned. MSF sounded the alarm regarding the potential harmful consequences of the trade deal ahead of the next round of RCEP negotiations starting in Perth, Australia this Friday. "Proposals in the RCEP negotiations are trying to introduce intellectual property measures far tougher on access to medicines than what is required under international trade rules", said Ms Leena Menghaney, South Asia Head of MSF's Access Campaign. "If accepted, the agreement would restrict access to affordable generic medicines for people in many countries that will be part of the agreement- including Indonesia, Thailand, Myanmar, Cambodia and Laos - and for the millions of people around the world who rely on life-saving affordable generic medicines from India." Text from the negotiations' leaked chapter on intellectual property shows that Japan and South Korea have made proposals that go beyond what international trade rules require undermining access to affordable generic medicines. "Many of the intellectual property provisions that have been tabled mirror those in the Trans-Pacific Partnership agreement, considered the worst trade deal ever for access to medicines", said Mr Brian Davies, East Asia Head for MSF's Access Campaign. "Countries that did not join the TPP -particularly India and key members of the Association of Southeast Asian Nations (ASEAN) - will be pushed to adopt similar standards in the RCEP negotiations." The measures that would harm access to affordable medicines are all the more concerning given India is one of the countries included in the RCEP negotiations. India-often known as the 'pharmacy of the developing world' for its wide-scale production of generic medicines-supplies life-saving affordable medicines needed to treat communicable and non-communicable diseases in developing countries. Two thirds of all the drugs MSF purchases to treat HIV, TB and malaria are generic medicines from India. In Perth, India will be under increasing pressure to roll back some of the hard-fought protections for access to medicines that have been secured by its negotiators in trade agreements in the past, who have stood firm against the most harmful provisions-such as extended patent terms and data exclusivity-which had been proposed but rejected both in the India-Japan Comprehensive Economic Partnership Agreement, and the ongoing negotiations for an EU-India Free Trade Agreement. One of the most damaging measures is data exclusivity, which would act like a patent to block the entry of more affordable generic medicines to the market, even for drugs that are already off patent, or do not deserve a patent to begin with. Other clauses harmful to access to medicines remain on the table, including extending patent terms, and introducing controversial aspects of intellectual property enforcement without the safeguards needed to prevent abuse and protect access to medicines. "If the measures in this agreement prevent people from getting the generic medicines they need, the health consequences for any delay or interruption of treatment for many diseases, like HIV, could be serious", said Dr Greg Elder, Medical Coordinator for MSF's Access Campaign. "97% of the HIV medicines MSF uses to treat 230,000 people living with the disease are generics sourced from India. The reality is, without generic medicines, we wouldn't be able to treat as many people as we do. We urge Indian and ASEAN negotiators to make sure the terms of any trade agreement reached do not impede the supply of generic medicines upon which we and so many people in developing countries rely." ]]> <![CDATA[SAGE issues recommendations to WHO for using dengue vaccine]]> https://biospectrumindia.com/news/95/2153/sage-issues-recommendations-to-who-for-using-dengue-vaccine.html https://biospectrumindia.com/news/95/2153/sage-issues-recommendations-to-who-for-using-dengue-vaccine.html Fri, 22 Apr 2016 14:47:05 +0530 The SAGE advises that countries with high dengue transmission consider introduction of the dengue vaccine as part of an integrated disease prevention strategy including vector control to effectively lower their dengue disease burden. Successful introduction of dengue immunization alongside other prevention efforts should help endemic countries to achieve the WHO objectives to reduce dengue morbidity by 25% and mortality by 50% by 2020. "We welcome these recommendations for Dengvaxia from SAGE, the advisory group to the WHO, for vaccines and immunization." said Dr Elias Zerhouni, MD, President of global R&D, Sanofi. "Dengvaxia has been approved in four countries already, including Mexico and Brazil, which have regulatory authorities recognized by the WHO. These WHO SAGE recommendations further validate the scientific and medical value of Dengvaxia and send a clear message to endemic countries about the strong public health benefit to be gained by introducing the dengue vaccine in integrated disease management efforts to combat their dengue burden." Dengvaxia vaccine's anticipated impact on dengue fever disease burden is expected to stem from the vaccine's proven ability to prevent 8 out of 10 dengue hospitalizations and up to 93% of severe dengue cases--including dengue hemorrhagic fever--in study participants 9 years and older, as demonstrated during 25 months of follow-up of phase III efficacy studies. The recommendations from the SAGE are based on the technical review of clinical data from 25 clinical studies conducted in 15 different endemic and non-endemic countries around the world, including more than 40,000 study participants. ]]> <![CDATA[Descovy to help Gilead maintain dominance of HIV market?]]> https://biospectrumindia.com/features/95/1025/descovy-to-help-gilead-maintain-dominance-of-hiv-market.html https://biospectrumindia.com/features/95/1025/descovy-to-help-gilead-maintain-dominance-of-hiv-market.html Thu, 21 Apr 2016 17:49:08 +0530 The recent FDA approval of Gilead Sciences' drug Descovy (emtricitabine/tenofovir alafenamide [TAF]) in the treatment of human immunodeficiency virus (HIV) will boost the company's TAF-based HIV portfolio, and allow Gilead to stay on top of a fast-changing treatment landscape, according to an analyst with research and consulting firm GlobalData. GlobalData's most recent HIV report says that the market will see major shifts in the types of treatments administered to patients in the next few years. Indeed, fixed-dosed combinations (FDCs) and single-tablet regimens (STRs) are transforming the HIV landscape, and tenofovir disoproxil fumarate (TDF) treatments are beginning to be challenged by clinically superior TAF-based therapies. Mr David Fratoni, MSc, GlobalData's Analyst covering Infectious Diseases, explains: "The launch of Descovy means Gilead is now responsible for bringing three TAFs to the US market in less than six months, including Genvoya (elvitegravir/cobicistat/emtricitabine/TAF) and Odefsey (emtricitabine/rilpivirine/TAF). This commitment to building a strong TAF profile represents a remarkable milestone for Gilead's fight against HIV, cementing its leading position in the arena for now. "Such a strategy comes at an opportune time for the company, as it encounters the rise of generic HIV regimens and branded FDCs and STRs. In fact, Gilead will have to face US and/or EU patent expirations of two of its TDF-based HIV therapies, Viread (TDF) and Truvada (emtricitabine/TDF), beginning in 2017, which will stimulate the entry of multi-tablet regimens from various generics manufacturers." Gilead hopes to switch patients currently taking its TDF-based brands onto its next-generation TAFs over the next 6-12 months. Indeed, this will go a long way to protecting the company from imminent expiries, as it is expected that physicians will be in favor of this new regimen following a recent study showing that switching to TAF-based drugs is associated with maintenance of virological suppression, non-inferior virological efficacy, and overall tolerability. Mr Fratoni continues: "Ultimately, the biggest threat to Gilead is competition from companies offering other branded drugs, not from generic manufacturers. Specifically, the strongest competitors are ViiV Healthcare and Janssen, which are currently working on a number of new HIV treatments to supplement their already-strong portfolios". "Although GlobalData expects Gilead's three TAF-based regimens to garner a solid portion of market share over the next few years, the potentially successful outcomes of Janssen's and ViiV's clinical trials could shift market dynamics, meaning pricing factors will be key to future US market sales." ]]> <![CDATA[Multi-blockbuster drugs to drive immuno-oncology market to $34 bn by 2024]]> https://biospectrumindia.com/features/95/7536/multi-blockbuster-drugs-to-drive-immuno-oncology-market-to-34-bn-by-2024.html https://biospectrumindia.com/features/95/7536/multi-blockbuster-drugs-to-drive-immuno-oncology-market-to-34-bn-by-2024.html Wed, 20 Apr 2016 14:08:36 +0530 The company's latest report states that the approval and uptake of immuno-oncology products is set to burgeon due to increased recognition of their long and durable tumor responses, which are similar to targeted therapies. Furthermore, these treatments have shown efficacy in a wide variety of indications and are not associated with the adverse side effects produced by traditional chemotherapy such as fatigue, neutropenia, or alopecia. Dr Dan Roberts, GlobalData's Senior Analyst covering Oncology and Hematology, says: "Immuno-oncology products have demonstrated comparable respective efficacy and safety profiles, so their commercial success will largely rest on the speed with which they enter the market, their clinical and commercial positioning, target patient populations, and the marketing power of the relevant pharmaceutical company." Ono/Bristol-Myers Squibb's Opdivo and Schering Plough/Merck and Co.'s Keytruda are set to be the highest-selling immuno-oncology drugs, with GlobalData forecasting multi-blockbuster sales of around $10 billion and $7 billion by 2024, respectively. Dr Roberts explains: "Both therapies, which are programmed cell death protein-1 (PD-1) inhibitors, will achieve such impressive sales due to the fact that they will be first-to-market in many indications, transcending competition such as Roche's atezolizumab and AstraZeneca's durvalumab. "Although Keytruda will have sales in more tumor types than Opdivo, the indications in which the latter will have advantage over its competitors will have the largest drug-treated populations, such as non-small cell lung cancer." The analyst adds that opportunities for late-to-market entrants will still remain, despite the market dominance of a small number of products. "As PD-1/ programmed death ligand-1 (PD-L1) inhibitors eventually saturate the oncology market, new developers are looking for ways to differentiate themselves. One way of doing this is by investigating various combinations of immuno-oncology treatments, with either other immuno-oncology or non-immuno-oncology products. "AstraZeneca is the company to look out for in regards to the development of novel combinations. Indeed, it has the most late-phase combination trials, predominantly investigating its internally-owned immuno-oncology combination product in a number of cancers," Roberts concludes. ]]> <![CDATA[Sanofi invests â‚¬300 mn to expand biologics site in Belgium]]> https://biospectrumindia.com/news/95/4773/sanofi-invests-300-mn-to-expand-biologics-site-in-belgium.html https://biospectrumindia.com/news/95/4773/sanofi-invests-300-mn-to-expand-biologics-site-in-belgium.html Tue, 19 Apr 2016 14:06:08 +0530 The investment in Geel, Belgium, furthers Sanofi's commitment to driving the future of biologics by expanding manufacturing and commercial capabilities in order to ensure quality, capacity, and scale. Through the investment, Sanofi plans to adapt and expand existing production capabilities to support Sanofi's pipeline of monoclonal antibodies. Updates to the existing facility will include the development of new laboratories focused on quality control and manufacturing sciences. "This investment not only strengthens our goal of becoming a leader in biologics but represents our focus on patients' needs," said Mr Philippe Luscan, Executive Vice President, Global Industrial Affairs and President of Sanofi in France. "We have a robust development pipeline of biological molecules, including monoclonal antibodies, and this investment furthers our work and expertise in key disease areas such as cardiovascular disease, rheumatoid arthritis, and atopic dermatitis. This is an exciting opportunity for our site in Geel and we are very pleased with the support we received from the Government of Flanders, the Flanders Investment and Trade and the Flanders Entrepreneurship agency." Sanofi and its specialty care global business unit, Sanofi Genzyme, have already invested â‚¬600 million in the Geel site, which began industrial biotech activities in 2001. The site is currently responsible for the global production of a protein therapy for Pompe disease, a rare, genetic muscular disease that is often fatal. The protein therapy is produced using cell cultures in large bioreactors, followed by a purification process. Through this latest investment, the state-of-the-art facility will add more than 8000 sq m of manufacturing floor space, enabling the site to increase its overall production capacity and diversify to other drugs and therapeutic areas. In support of this expansion, Sanofi intends to recruit and leverage the expertise of highly-skilled biotechnology professionals to fulfill a range of job functions. "As an open economy, Flanders thrives on international trade and investments," said Mr Geert Bourgeois, Minister-President of Flanders. "Life sciences is a sector with many innovative opportunities, not only for multinationals but also for small and medium sized enterprises. Locally, we have succeeded in attracting significant investments year after year and the Government of Flanders is right to keep investing heavily in this sector. Sanofi's decision to select Flanders reinforces our expertise and professional talent to support these types of investments." ]]> <![CDATA[APAC countries vow to tackle antimicrobial resistance together]]> https://biospectrumindia.com/news/95/7718/apac-countries-vow-to-tackle-antimicrobial-resistance-together.html https://biospectrumindia.com/news/95/7718/apac-countries-vow-to-tackle-antimicrobial-resistance-together.html Mon, 18 Apr 2016 15:58:26 +0530 Health ministers from 12 countries of the region agreed to improve the way information on antimicrobial resistance is collected and shared to guide effective policies and actions; to strengthen and harmonize how they regulate the production, sale and use of antibiotics and other antimicrobial medicines; and to take innovative approaches to stimulate research and development of new antibiotics, diagnostic tests, vaccines and other technologies, a communique issued on the Tokyo Meeting of Health Ministers on Antimicrobial Resistance said. "Antimicrobial resistance is a threat to global security and economic stability. It is a looming health and economic crisis that requires both global and local solutions. Since drug resistant genes can travel, countries with higher levels of economic and social organization have a stake in the success of measures taken by less developed countries. In the fight against antimicrobial resistance, we are only as strong as the weakest link," Dr Poonam Khetrapal Singh, WHO Regional Director for South-East Asia, told ministers at the meeting. The ministerial meeting followed a two-day brainstorming session among experts and organizations representing public health, agriculture and animal health, was organized by the Government of Japan and WHO, in collaboration with the Food and Agriculture Organization of the United Nations and the World Organization for Animal Health. "Antibiotic resistance is one of the biggest threats to human health today. Having effective antimicrobials is also critical to the social and economic development of nations. We have a limited window of opportunity to take action and avoid a post-antibiotic era. WHO is supporting countries across the Asia Pacific region to take critical steps to preserve the effectiveness of these life-saving medicines. We must strengthen health systems' response and cooperation with the agriculture sector to contain this threat, and improve understanding of the problem among the public. The Tokyo meeting has provided a platform to move forward with this important agenda," said Dr Shin Young-soo, World Health Organization (WHO) Regional Director for the Western Pacific. Rapid economic development and socio-demographic and cultural changes, coupled with the health status, puts the population of the Asia Pacific region at higher risk for emerging drug-resistant infections, evident by the spread of multidrug resistant strains of malaria and tuberculosis. Ministers acknowledged that antimicrobial resistance is a by-product of system failures-from regulation of medicines to agricultural and trade controls-and strengthening these systems is a critical component of the Sustainable Development Goals. They agreed on the need for urgent action to raise awareness across all sectors of the need for responsible use of antibiotics. The region's health ministers pledged to take a multi-sectoral approach, with effective governance mechanisms, to enable all stakeholders to work collectively and effectively. Accelerating progress towards universal health coverage-to ensure people across the region have equitable access to quality health services, including the prevention and control of infections and rational prescribing of antibiotics-was another key initiative emphasized and agreed upon by ministers. WHO has called for urgent collaboration to slow down antimicrobial resistance and avoid a post-antibiotic era-in which minor wounds and injuries could be life- threatening, and treatments longer and more costly, causing economic hardships to families, societies and countries. The World Health Assembly in 2015 endorsed a Global Action Plan on Antimicrobial Resistance. In line with this, WHO is supporting countries in the Asia Pacific region to develop national action plans. Priority areas include: improving awareness and understanding of the problem; strengthening surveillance of infections in humans and animals which are resistant to antimicrobials; reducing the incidence of infections; promoting rational use of antibiotics in all sectors; and promoting investments in research. Ministers or senior officials from Australia, Bangladesh, China, India, Indonesia, Japan, Malaysia, Myanmar, Philippines, Republic of Korea, Thailand and Viet Nam, and representatives of WHO and other partner organizations attended the meeting. WHO's South-East Asia Region comprises the following 11 Member States: Bangladesh, Bhutan, Democratic People's Republic of Korea, India, Indonesia, Maldives, Myanmar, Nepal, Sri Lanka, Thailand and Timor-Leste. ]]> <![CDATA[Global viral infections market to reach $117.6 bn by 2021]]> https://biospectrumindia.com/features/95/7717/global-viral-infections-market-to-reach-117-6-bn-by-2021.html https://biospectrumindia.com/features/95/7717/global-viral-infections-market-to-reach-117-6-bn-by-2021.html Mon, 18 Apr 2016 11:51:20 +0530 The company's latest report states that the expanding treatment population, which has resulted from improved treatment options and global initiatives to improve access to treatment for many people living with chronic debilitating viral infections such as HIV, will be a key driver of this growth. Rising therapy costs resulting from the uptake of recently approved, highly-priced antiviral agents, as well as promising late-stage candidates which are expected to be priced highly, will also be a factor. Ms Fiona Chisholm, Analyst for GBI Research, states that: "Some 1,848 pipeline products are specifically in development for the treatment of viral infections, accounting for a sizeable proportion of the infectious diseases pipeline. Among these products, HIV has the most at an active stage of development, with 419, followed by influenza, Hepatitis C and Hepatitis B, with 333, 222 and 150 pipeline products, respectively. "Such strong activity is indicative of a high degree of commercial interest in viral infections in general, and in these key indications in particular, which reflects the commercial success of currently marketed products such as Truvada, Atripla and Harvoni. However, it should be noted that many products in the viral infections pipeline are being developed for multiple indications, including infectious diseases attributable to non-viral micro-organisms." GBI Research also states that generic penetration is projected to increase considerably over the forecast period, especially in the seven major markets of the US, France, Germany, Italy, the UK, Spain, and Japan. Ms Chisholm continues: "The availability of generic drugs is expected to increase due to a series of recent and upcoming patent expirations for key marketed products, particularly within HIV. "Due to enhanced cost-consciousness, clinicians will increasingly favor generic drugs over premium products in order to reduce the cost of treatment. However, the strength of innovation will continue to drive the global viral infections space, as demonstrated by the strong growth." ]]> <![CDATA[Biotech/GM Crops planted on Two Billion Hectares from 1996 to 2015 ]]> https://biospectrumindia.com/news/95/7150/biotech-gm-crops-planted-on-two-billion-hectares-from-1996-to-2015-.html https://biospectrumindia.com/news/95/7150/biotech-gm-crops-planted-on-two-billion-hectares-from-1996-to-2015-.html Fri, 15 Apr 2016 12:43:00 +0530 International Service for the Acquisition of Agri-Biotech Applications (ISAAA) released its annual report detailing the adoption of biotech crops, "20th Anniversary of the Global Commercialization of Biotech Crops (1996-2015) and Biotech Crop Highlights in 2015," showcasing the global increase in biotech hectarage from 1.7 million hectares in 1996 to 179.7 million hectares in 2015. This 100-fold increase in just 20 years makes biotechnology the fastest adopted crop technology in recent times, reflecting farmer satisfaction with biotech crops. Since 1996, 2 billon hectares of arable land - a massive area more than twice the landmass of China or the United States - have been planted with biotech crops. Additionally, it is estimated that farmers in up to 28 countries have reaped more than US$150 billion in benefits from biotech crops since 1996. This has helped alleviate poverty for up to 16.5 million small farmers and their families annually totaling about 65 million people, who are some of the poorest people in the world. "More farmers are planting biotech crops in developing countries precisely because biotech crops are a rigorously-tested option for improving crop yields," said Clive James, founder and emeritus chair of ISAAA, who has authored the ISAAA report for the past two decades. "Despite claims from opponents that biotechnology only benefits farmers in industrialized countries, the continued adoption of the technology in developing countries disproves that" James added. For the fourth consecutive year, developing countries planted more biotech crops (14.5 million hectares) than industrialized countries. In 2015, Latin American, Asian and African farmers grew biotech crops on 54 percent of global biotech hectarage (97.1 million hectares of 179.7 million biotech hectares) and of the 28 countries that planted biotech crops, 20 were developing nations. Annually, up to 18 million farmers, 90 percent of whom were small, resource-poor growers in developing countries, benefited from planting biotech crops from 1996 to 2015. "China is just one example of biotechnology's benefits for farmers in developing countries. Between 1997 and 2014, biotech cotton varieties brought an estimated $17.5 billion worth of benefits to Chinese cotton farmers, and they realized $1.3 billion in 2014 alone," explained ISAAA Global Coordinator, Randy Hautea. Also in 2015, India became the leading cotton producer in the world with much of its growth attributed to biotech Bt cotton. India is the largest biotech cotton country in the world with 11.6 million hectares planted in 2015 by 7.7 million small farmers. In 2014 and 2015, an impressive 95 percent of India's cotton crop was planted with biotech seed; China's adoption in 2015 was 96 percent. "Farmers, who are traditionally risk-averse, recognize the value of biotech crops, which offer benefits to farmers and consumers alike, including drought tolerance, insect and disease resistance, herbicide tolerance, and increased nutrition and food quality," Hautea added. "Moreover, biotech crops contribute to more sustainable crop production systems that address concerns regarding climate change and global food security." Following a remarkable run of 19 years of consecutive growth from 1996 to 2014, with 12 years of double-digit growth, the global hectarage of biotech crops peaked at 181.5 million hectares in 2014, compared with 179.7 million hectares in 2015, equivalent to a net marginal decrease of 1 percent. This change is principally due to an overall decrease in total crop hectarage, associated with low prices for commodity crops in 2015. ISAAA anticipates that total crop hectarage will increase when crop prices improve. For example, Canada has projected that canola hectarage in 2016 will revert to the higher level of 2014. Other factors affecting biotech hectarage in 2015 include the devastating drought in South Africa, which led to a massive 23 percent decrease of 700,000 hectares in intended plantings in 2015. The drought in eastern and southern Africa in 2015/2016 puts up to 15 to 20 million poor people at risk for food insecurity and compels South Africa, usually a maize exporter, to rely on maize imports. ]]> <![CDATA[Hot Start-ups: Skilling the next-gen in Biotech & Pharma space]]> https://biospectrumindia.com/features/95/8174/hot-start-ups-skilling-the-next-gen-in-biotech-pharma-space.html https://biospectrumindia.com/features/95/8174/hot-start-ups-skilling-the-next-gen-in-biotech-pharma-space.html Thu, 14 Apr 2016 17:39:35 +0530 Hailing from Uttar Pradesh (UP), he says that all his seniors who graduated in Biotechnology actually didn't have any clear-cut idea about their job profiles or the companies in the sector. Everyone told him: 'Bahar (abroad) bahut scope hai, but kahan pata nahi'. This triggered off something within Mr Bhardwaj. He initially planned to start a career counseling portal specifically for Biotech and Pharma students. But it went on to becoming a start-up offering skill development training programs and providing free career counseling. Two years after graduating, he was armed with a couple of years' experience in a Biotech start-up as a corporate relations manager. It was during his first job at this start-up he was determined to learn all the basic skills needed to build his own start-up in the future. The job offered him extensive learning experience in marketing, operations, financial aspects and overall administration. The young Mr Bhardwaj in 2011 set off on a journey to create his start-up Rapture Biotech, with a vision to offer best-in-class training programs for both academia and corporates in the Biotech and Pharma space. The start-up offers short-term and project training programs for Biotech and Pharma students, while providing skill development trainings for corporate employees. Located in UP, Rapture Biotech's other divisions include Bioteknow and 3S Biosolution. Bioteknow is a centralized platform where any company or institute can offer their training programs. It also publishes its magazine 'Bioteknow' for Biotech career counseling purposes. 3S Biosolution provides R&D solutions and related services. It supplies, manufactures, and exclusively represents many international brands in India providing bioprocess & R&D solutions, and bioinformatics software for research purposes. The start-up has tie-ups with 40+ international companies for research products sales in India. Its research team is constantly working on developing cheaper research products. It also boasts of 100+ tie-ups with major colleges and universities in India. Similar to other Biotech entrepreneurs, Mr Bhardwaj says that convincing his family about his entrepreneurial decision and arranging for the needed fund to start were two major challenges he faced initially However, through seed funding and his own personal savings he was able to successfully incorporate his dream start-up. "The trends are changing nowadays. Venture capitalists (VC) and clients have started accepting and promoting first generation young entrepreneurs. However, VCs fail to understand start-ups' incubation period, and the technical integration of projects," Mr Bhardwaj comments. The company is expanding its business model through franchise partner program. It has 2 successful franchises in Agra (UP) and Bhopal (MP). It is also coming up with new franchises in Nepal and Andhra Pradesh (AP). Further, the start-up intends to expand internationally to UAE, Sri Lanka and Bangladesh. It currently has an ambitious target of hitting Rs 10 crore in revenues in the next 2 to 3 years. To increase its visibility, the start-up has started offering free career counseling programs, workshops in colleges, and an active social media marketing strategy. From the Government's side, he expects it to enable quick and easy start-up loans, and building Bio-entrepreneurs development centers in the country, and laying emphasis on creating Biotech clusters and Special Economic Zones (SEZs). "In Western countries, the start-up environment is totally different. They promote entrepreneurship at a very early stage in universities itself," Mr Bhardwaj opines. He says that Personal Genomics, Molecular Diagnostics & Instrumentation are happening areas for start-ups. Mr Bhardwaj points that Delhi -NCR Region and Pune are the two start-up hubs because of the presence of major Government laboratories and central government offices enabling favorable technical support and acquiring clients. The entrepreneur highlights patience as the key to be an entrepreneur in the Biotech industry. "Educational background does play a key role in being a bio-entrepreneur. Candidates from abroad universities or IITs do have advantage, especially when it comes to VC funding part," he states, an admirer of Biocon's CMD Dr Kiran Mazumdar. Mr Bhardwaj constantly derives motivation by reading success stories of other entrepreneurs. He enjoys playing mobile games as a way to relax and unwind. "It is better to start now because it is never too early. It is important to self-motivate and believe in oneself. There is no failure in entrepreneurship. It is either a success or a delayed success," Mr Bhardwaj concludes. Entrepreneurial Mistake To Avoid: ï‚§ Not learning all the sides of a businessï‚§ Hiring wrong peopleï‚§ Having smaller margins Start-up Myths To Debunk: ï‚§ Entrepreneurs are born, not made ï‚§ In Life Sciences, young entrepreneurs can't sustain business for longï‚§ Starting a business is easy ]]> <![CDATA[Orchid receives FDA nod for Rasagiline generic formulation]]> https://biospectrumindia.com/news/95/8309/orchid-receives-fda-nod-for-rasagiline-generic-formulation.html https://biospectrumindia.com/news/95/8309/orchid-receives-fda-nod-for-rasagiline-generic-formulation.html Thu, 14 Apr 2016 15:23:19 +0530 Chennai-based Pharma major, Orchid Pharma has received final approval from the US FDA for its ANDA (Abbreviated New Drug Application) for Rasagiline Tablets 0.5 mg and 1 mg. This product is a FTF (First-to-file) application with a shared 180-day exclusivity for Orchid. Orchid expects to launch this product in Q4 of FY 16-17. Rasagiline Mesylate Tablets are indicated for the treatment of the signs and symptoms of idiopathic Parkinson's disease. With a market size of over US$ 300 million and limited generic competition, Orchid hopes to garner a decent market share from this product launch. ]]> <![CDATA[Sun Pharma receives FDA approval for BromSite]]> https://biospectrumindia.com/news/95/7936/sun-pharma-receives-fda-approval-for-bromsite.html https://biospectrumindia.com/news/95/7936/sun-pharma-receives-fda-approval-for-bromsite.html Wed, 13 Apr 2016 11:33:58 +0530 Sun Pharma has announced that one of its wholly owned subsidiaries has received approval from USFDA for its New Drug Application (NDA) related to BromSite (bromfenac ophthalmic solution) 0.075% for the treatment of postoperative inflammation and prevention of ocular pain in patients undergoing cataract surgery. BromSite is the first non-steroidal anti-inflammatory drug (NSAID) approved by the USFDA to prevent pain and treat inflammation in the eye for patients undergoing cataract surgery; other NSAIDs in this class are currently indicated for the treatment of inflammation and reduction of pain. BromSite developed by InSite Vision, is the first bromfenac ophthalmic solution formulated in DuraSite, a polymer-based formulation that can be used to improve solubility, absorption, bioavailability, and residence time as compared to conventional topical therapies. Sun Pharma acquired InSite Vision in November 2015 and is likely to commercialize BromSite through its newly formed, US-based division, Sun Ophthalmics, in the second half of 2016. Sun Ophthalmics has crossed a key business milestone through BromSite's approval. Sun Ophthalmics targets to provide eye care practitioners products that enhance their practice patterns and treatment options and to deliver those products through its unique, concierge level approach to customer care. With BromSite's approval and additional late-stage candidates in its pipeline, Sun Ophthalmics is strongly positioned to offer a range of beneficial products and establish itself as a respected and trusted partner. "Over the years, I've worked closely with the InSite team and watched them develop multiple high quality products using the DuraSite platform," commented Dr Richard L. Lindstrom, MD, founder and attending surgeon of Minnesota Eye Consultants and Adjunct Professor Emeritus at the University of Minnesota Department of Ophthalmology. "Today, I am pleased to see BromSite advance from development to market. I am confident there will be significant clinician interest in this new product. As the first NSAID labeled to prevent pain and reduce inflammation post-cataract surgery, BromSite's approval is timely and will be welcomed by patients and cliniciansalike," he added. ]]> <![CDATA[Lupin to market Novartis' Inhaler in India]]> https://biospectrumindia.com/news/95/3770/lupin-to-market-novartis-inhaler-in-india.html https://biospectrumindia.com/news/95/3770/lupin-to-market-novartis-inhaler-in-india.html Wed, 13 Apr 2016 11:32:33 +0530 Pharma Major Lupin Limited (Lupin) and Novartis Healthcare Private Limited (NHPL) have entered into a co-marketing agreement to promote Novartis's Indacaterol / Glycopyrronium 110mcg/50mcg inhaler, a treatment for chronic obstructive pulmonary disease (COPD) under the brand name of Loftair. Lupin would be using its own specialty field force to promote Loftair inhaler. NHPL will continue to market Indacaterol / Glycopyrronium 110mcg/50mcg inhaler under its brand name Sequadra through its own sales force. Loftair is a fixed dose combination of two bronchodilators: Indacaterol maleate, a long-acting beta2-adrenergic agonist (LABA) and glycopyrronium bromide, a long-acting anticholinergic (LAMA) for the treatment of COPD. The once daily Indacaterol / Glycopyrronium combination significantly reduced the rate of moderate or severe exacerbations by 31% compared to the current standard of care (SFC twice-daily salmeterol + fluticasone combination) in patients with moderate-to-severe chronic obstructive pulmonary disease. This combination has also shown superior efficacy vs SFC (salmeterol/fluticasone) for lung function, breathlessness (assessed using the Transition Dyspnea Index), health-related quality of life (measured using the St George's Respiratory Questionnaire) and on-demand (rescue medication) salbutamol use. Indacaterol / Glycopyrronium combination is approved for use in COPD in 82 countries including US, EU, Japan, Canada, countries within Latin America and Australia. The agreement helps address the growing incidence of COPD, by making better treatment options available to patients in India. Announcing the agreement, Mr Shakti Chakraborty, group president, India Region Formulations, Lupin said, "We at Lupin are excited about the expansion of our ongoing partnership with Novartis Healthcare Private Limited (NHPL) for the Inhalation / COPD segment. We had previously entered into a similar agreement with NHPL to market Onbrez. We are confident that this partnership for Loftair will enable us to further consolidate and strengthen our market leadership within the Indian COPD, Anti-Asthma, Inhalation therapy segments." ]]> <![CDATA[Recipharm completes acquisition of a majority stake in Indian CMO Nitin Life sciences]]> https://biospectrumindia.com/news/95/8325/recipharm-completes-acquisition-of-a-majority-stake-in-indian-cmo-nitin-life-sciences.html https://biospectrumindia.com/news/95/8325/recipharm-completes-acquisition-of-a-majority-stake-in-indian-cmo-nitin-life-sciences.html Tue, 12 Apr 2016 09:51:44 +0530 Recipharm AB announces that it has completed the acquisition of a majority stake in Nitin Lifesciences Limited, an Indian sterile injectables CMO, currently owned by the Sobti family. Recipharm has acquired 74 % of the shares for a purchase consideration of INR 6,713 million on a cash and debt free basis. Thomas Eldered, CEO of Recipharm said "I am delighted that we have now completed this transaction. The combination of Nitin and Recipharm represents an important step in the development of both companies and I am pleased that both Dr Chetan Sobti and Nitin Sobti will be continuing in their current positions". Mr. M.M Sobti, founder of Nitin Lifesciences Ltd., commented "This partnership represents a real opportunity to take Nitin Lifesciences to a new level. The combination allows both organisations to access a wider customer base and to gain important learning from each other. The Sobti family is very pleased to be entering into this new strategic partnership which will be hugely beneficial for both companies". Highlightsâ€¢ The combined entity will have enhanced scale, reach and profitability. Nitin Lifesciences had 2015 net sales of approximately INR 2,970 million, corresponding to 12 % of Recipharm's 2015 total net sales. The EBITDA margin 2015 was approximately 24 %. â€¢ Significantly bolsters presence in high growth developing territories and the deal firmly establishes Recipharm's emerging market strategy. Provides excellent exposure and direct entry into the rapidly expanding Indian market. â€¢ Recipharm's global position in sterile injectables including lyophilization will be further strengthened. â€¢ The implied value for 100 % of Nitin equates to INR 9,071 million and represents approximately 11.7 times 2015 EBITDA of INR 721 million. â€¢ Accretive to organic growth and EPS. ]]> <![CDATA[Project HOPE makes strides against Diabetes and Hypertension in India]]> https://biospectrumindia.com/news/95/7256/project-hope-makes-strides-against-diabetes-and-hypertension-in-india.html https://biospectrumindia.com/news/95/7256/project-hope-makes-strides-against-diabetes-and-hypertension-in-india.html Mon, 11 Apr 2016 12:10:00 +0530 Project HOPE, the global health organization, is experiencing great success in India in its role in Project UDAY (which means "dawn" or "sunrise" in Hindi), a comprehensive diabetes and hypertension prevention and management program supported by Eli Lilly and Company under the Lilly NCD Partnership. According to the International Diabetes Federation, India has the second largest population living with diabetes in the world, second only to China. Higher incomes, more sedentary lifestyles and diets heavy in starches and sugars as well as high blood pressure are all factors contributing to the spread of the disorder. While today there are about 65 million people with diabetes in India, the number is expected to increase to 109 million by 2030. Launched in 2012, Project UDAY is led by the Public Health Foundation of India (PHFI), New Delhi in partnership with Population Services International (PSI) and Project HOPE. UDAY comprises a priority set of five synergistic ecosystem interventions with the overarching goal to prevent, detect, and reduce the risk of diabetes and hypertension and to improve the management of individuals with either of these conditions in two study sites. These sites are two geographically and culturally distinct areas (South and North India) located in Vishakhapatnam (Vizag) in the state of Andhra Pradesh and Sonipat in Haryana. Project HOPE's main focus is to address the magnitude of diabetes and hypertension by developing skilled health care professionals and non-communicable diseases (NCD) patient networks for community empowerment. As the capacity building partner, Project HOPE is focused on advancing knowledge for transformative action towards early detection, prevention, management and timely referrals of NCDs. This involves understanding and responding to the specific needs of the community towards NCD care and management. To maximize learning, Project HOPE has crafted its training methodology on the VIPP (Visualization in Participatory Programs) approach which involves adult participatory learning. Extensively participatory, it pivots around case scenario build-ups, informative live sessions, demonstrations and role plays and interactive exercises and games. The methodology creates a technology independent environment that is conducive to staying engaged throughout for advanced learning. Adaptable to audience requirements, it has been successful in enhancing the capacity of health workers for community interaction and counseling, and in motivating them to promote opportunistic screenings in different socio-cultural contexts. This package has been complemented with advocacy efforts to secure increased attention and involvement of the government for scaling up and mainstreaming NCD related activities. For the first time in India, our unique, evidence-based approach will be applied to create effective patient networks in the field of noncommunicable disease. This will enable the community to identify successful behaviors and strategies, and develop action plans to adopt them. "India's greatest national treasure is our people. We cannot afford to neglect their wellbeing and allow so many of our citizens to face the consequences of NCDs. Project HOPE's approach in UDAY is mobilizing patients through patient networks and at the same time strengthening the service delivery via health care workers," said Ms Cheena Malhotra, Program Manager for Project HOPE India. "Project HOPE has been very pleased with the success of the program where participating health workers showed 95% of improvement in knowledge on the posttest verses 15% at the beginning of the training." "Through UDAY, we are bringing meaningful, long-term changes that benefit people with diabetes today and will hopefully prevent its onset with others moving forward," said Mr Craig Waugh, Global Leader, Lilly NCD Partnership. "Our ultimate goal is to use the research coming out of projects like UDAY to advocate for wider scale up in order to positively impact more people in India." ]]> <![CDATA[WHO India honours public health champions]]> https://biospectrumindia.com/news/95/8266/who-india-honours-public-health-champions.html https://biospectrumindia.com/news/95/8266/who-india-honours-public-health-champions.html Mon, 11 Apr 2016 12:08:40 +0530 At a national consultation held on 7 April 2016 at New Delhi jointly with the Ministry of Health & Family Welfare (MoHFW), Government of India (GoI) to commemorate the World Health Day 2016 (7 April), the WHO Country Office for India gave out awards for Public Health Champions. The award winners were: Dr Paresh Vamanrao Dave, Government of Gujarat; Mahan Trust, Maharashtra; and SEARCH, Gadchiroli, Maharashtra for sustained contribution to public health. In the category of innovation, the awardees were Dr Bindeshwar Pathak, Sulabh International and Sangath, Goa. Amongst other stakeholders and dignitaries, present on the occasion were Mr Jagat Prakash Nadda, Union Minister of Health & Family Welfare (MoHFW); Mr Shripad Naik, Minister of State for Health & Family Welfare and Minister of State (IC), AYUSH; Dr Jitendra Singh, Minister of State for the Ministry of Development of North Eastern Region (IC), Prime Minister Office, Personnel, Public Grievances and Pensions, Department of Atomic Energy and Department of Space; Mr B.P.Sharma, Secretary, MoHFW; Dr Soumya Swaminathan, Secretary, Department of Health Research & Director General, Indian Council of Medical Research (ICMR), MoHFW; Mr K B Agarwal, Additional Secretary, MoHFW; Dr Arun Panda, Additional Secretary, MoHFW; Mr C.K. Mishra, Additional Secretary and Mission Director, National Health Mission, MoHFW; Dr Jagdish Prasad, Director General Health Services; Mr Anshu Prakash, Joint Secretary, MoHFW and Dr Henk Bekedam, WHO Representative to India. Highlighting the importance of the public health champions awards, Dr Henk Bekedam, WHO Representative to India said, "Public health is key to improving people's health. The individuals and organizations who toil hard to bring about impactful, innovative and sustainable changes in this field are often unsung heroes. These awards are our attempt to bridge this gap and recognize the talented individuals and organizations in public health. We do hope that the Public Health Champions awards will encourage others to emulate them." The rationale for recognizing public health champions is to honour efforts of both, individual(s) and institution(s) who have made an outstanding contribution to public health through advocacy for and involvement in impactful health policies and programmes with proven public health achievements and substantial improvement in equitable health outcomes in the country. The awards comprise two categories: sustained contribution to the field of public health, and innovation. The scope of the awards covers contributions to significant advances in population and person focused services and inter-sectoral actions. In addition, contributions that have assisted WHO in performing any one of its six core functions are taken into consideration. ]]> <![CDATA[World Health Day 2016: Let's beat diabetes]]> https://biospectrumindia.com/news/95/8265/world-health-day-2016-lets-beat-diabetes.html https://biospectrumindia.com/news/95/8265/world-health-day-2016-lets-beat-diabetes.html Mon, 11 Apr 2016 12:06:27 +0530 A consultation, organized by the WHO Country for India in collaboration with the Ministry of Health & Family Welfare, Government of India, on the occasion of the World Health Day 2016 made a strong call to all stakeholders to scale-up prevention, strengthen care and enhance surveillance to beat diabetes. Among other stakeholders and dignitaries, present on the occasion were Mr Jagat Prakash Nadda, Union Minister of Health & Family Welfare (MoHFW); Mr Shripad Naik, Minister of State for Health & Family Welfare and Minister of State (IC), AYUSH; Dr Jitendra Singh, Minister of State for the Ministry of Development of North Eastern Region (IC), Prime Minister Office, Personnel, Public Grievances and Pensions, Department of Atomic Energy and Department of Space; Mr B.P. Sharma, Secretary, MoHFW; Dr Soumya Swaminathan, Secretary, Department of Health Research & Director General, Indian Council of Medical Research (ICMR), MoHFW; Mr K. B. Agarwal, Additional Secretary, MoHFW; Dr Arun Panda, Additional Secretary, MoHFW; Mr C.K. Mishra, Additional Secretary and Mission Director, National Health Mission, MoHFW; Dr Jagdish Prasad, Director General Health Services; Mr Anshu Prakash, Joint Secretary, MoHFW and Dr Henk Bekedam, WHO Representative to India. The Union Health Minister Mr J.P. Nadda highlighted the significance of a healthy lifestyle to combat noncommunicable (NCD) diseases such as diabetes and hypertension. He launched various mobile apps to create awareness regarding NCDs and for strengthening and empowering health workers in discharging their duties. In her World Health Day message, Dr Poonam Khetrapal Singh, Regional Director, WHO South-East Asia said, "Diabetes rarely makes headlines, and yet it will be the world's seventh largest killer by 2030 unless intense and focused efforts are made by governments, communities and individuals." The Union Health Minister also launched on the occasion a number of initiatives: ICMR India DIABetes [INDIAB] Study Phase I; Guidelines on Dialysis Centre in a PPP Mode; 'Swasthya Bharat' Mobile Application; 'ANMOL' ANM Online Tablet Application; 'e-RaktKosh'; and 'India Fights Dengue' mobile application. Mr Nadda also released the WHO Global Report on Diabetes and WHO India Technical Report on Diabetes in India at the consultation. Speaking on the occasion, Dr Henk Bekedam, WHO Representative to India said, "Diabetes is a growing challenge in India. Simple lifestyle measures have been shown to be effective in preventing or delaying the onset of type 2 diabetes. Early screening, increased access to health care services, affordable diagnosis and treatment and patient empowerment for self-management are vital components to control diabetes." "Diabetes and other NCDs represent a challenge to public health and national development. It is, therefore, imperative that we tackle this challenge now than later," he added. "Let us all resolve to beat diabetes," he urged. Efforts to prevent and treat diabetes are important for achieving the Sustainable Development Goal, Target 3.4, dedicated to reducing premature mortality from NCDs by one-third by 2030. The consultation saw active participation and the discussions focused on a broad range of issues on diabetes. The deliberations emphasized the need for multisectoral interventions for prevention of diabetes by supporting and strengthening integration of NCD prevention strategies within the plans and programmes of the non-health sector. On the occasion, the WHO Country Office for India awarded the Public Health Champions for outstanding contribution to public health in India. These awards recognize and honour the best in the field in order to encourage them to press forward and others to emulate them. The award winners were: Dr Paresh Vamanrao Dave, Government of Gujarat; Mahan Trust, Maharashtra; and SEARCH, Gadchiroli, Maharashtra for sustained contribution to public health. In the category of innovation, the awardees were Dr Bindeshwar Pathak, Sulabh International and Sangath, Goa. The main goals of WHD 2016 are to increase awareness about the rise in diabetes, and its staggering burden and consequences and to trigger a set of specific, effective and affordable actions to tackle diabetes. State-level consultations on the theme of World Health Day have also been organized at Hyderabad, Bangalore, Patna and Lucknow. ]]> <![CDATA[Haryana joins the Call to action for a TB-Free India]]> https://biospectrumindia.com/news/95/4088/haryana-joins-the-call-to-action-for-a-tb-free-india.html https://biospectrumindia.com/news/95/4088/haryana-joins-the-call-to-action-for-a-tb-free-india.html Thu, 07 Apr 2016 14:02:14 +0530 Medanta - The Medicity hospital organized a conference on Lung Health and Tuberculosis (TB) to discuss the need for improved TB diagnosis to make Haryana TB-Free. Dr Sunil Khaparde, DDG, Central TB Division; Dr A Jaiswal, National Institute of TB and Respiratory Diseases, Dr Bornali Dutta, Senior Consultant, Respiratory Medicine, Dr Reuben Swamicken, US Agency for International Development (USAID), Ms Kavita Ayyagari, Project Director - Challenge TB, The Union and Dr Jamhoih Tonsing, Director, The Union South-East Asia Office were present at the event. The results from the phase I of Mission TB-Free Haryana and the plan for phase II were discussed. Mission TB-Free Haryana aims to identify patients that suffer from TB, but are sputum negative and therefore not detected early or start treatment. The digital X-Ray helps identify symptomatic pulmonary TB in patients who are sputum negative and refers them to Government TB centers for treatment. The Mobile Van is present at the primary and community health centres (PHCs and CHCs) at the village and block level, where X-Ray facilities are not available. ASHA workers refer the symptomatic patients for testing and the District TB officers have been supporting this initiative by taking active interest in case detection and referrals. Dr Sunil Kaparde, deputy director general, Central TB Division, said, "Dr Trehan has a vision for TB-Free Haryana and this initiative of the Medanta Mobile Vans will definitely contribute to the cause of TB-Free India as this will help reach those TB patients not reached through the program and start them on treatment earlier. If Medanta can add linkages with the CBNAAT testing facilities now being introduced through the Government, and offer this facility itself, this will help further identify drug resistant TB patients." Mission TB-Free Haryanaâ€¢ The pilot of this project was conducted in Rewari where of 354 patients, 122 tested positive on X-Ray for pulmonary TB, accounting a 35 per cent positive rate for X-Ray screening. â€¢ Based on the success in one district, and responding to the Call to Action for a TB-Free India, Medanta committed to extend diagnostic support to the RNTCP in all districts of Haryana, in a phased manner over the next 5 years. â€¢ The phase I of Mission TB-Free Haryana started on December 1, 2015, spanning 5 districts of the state which included Gurgaon, Mewat, Jhajjar, Palwal and Rewari. 698 suspected TB patients were screened during this period, of which 265 were diagnosed positive on digital chest X-Ray through the Medanta Mobile Van and started on DOTS. â€¢ An intensive drive for three weeks in Mewat helped in diagnosing 215 positive TB cases of the suspected 625. â€¢ The programme is continuing in these districts and will be expanded to Sonepat, Rohtak, Bhiwani, Faridabad and Mahendergarh in phase II. Ms Kavita Ayyagiri, project director - Challenge TB, The Union said, "With the current decline rate of 2 percent in TB cases annually, much more needs to be done to reach the zero TB goal. We are happy that a leading hospital like Medanta has taken forward this initiative to diagnose TB patients in remote and rural areas of the state of Haryana. This initiative has the support of the Central TB division and the State and District TB Officers. It is an example of how public private partnerships that are collaborative and complementary can help reach patients." Dr Naresh Trehan, chairman and managing director, Medanta - The Medicity was part of the Mumbai Dialogue: Towards a TB-free India and announced the expansion of this initiative to all districts of Haryana. The 'TB-free India' Campaign is a part of the Global Challenge TB Project funded by the US Agency for International Development (USAID) and International Union against Tuberculosis and Lung Diseases (The Union) is providing technical assistance for this initiative. Expansion of services to entire state requires at-least five mobile vans and moving in a hub and spoke manner across districts. There is a need for resources to come together through multi-lateral partnerships. ]]> <![CDATA[Mega Miss: Pfizer terminates proposed merger with Allergan]]> https://biospectrumindia.com/news/95/7561/mega-miss-pfizer-terminates-proposed-merger-with-allergan.html https://biospectrumindia.com/news/95/7561/mega-miss-pfizer-terminates-proposed-merger-with-allergan.html Thu, 07 Apr 2016 11:53:13 +0530 Pfizer Inc. has announced that the merger agreement between Pfizer and Allergan plc has been terminated by mutual agreement of the companies. The decision was driven by the actions announced by the US Department of Treasury on April 4, 2016, which the companies concluded qualified as an "Adverse Tax Law Change" under the merger agreement. "Pfizer approached this transaction from a position of strength and viewed the potential combination as an accelerator of existing strategies," stated Mr Ian Read, chairman and chief executive officer, Pfizer. "We remain focused on continuing to enhance the value of our innovative and established businesses. Our most recent product launches, including Prevnar 13 in Adults, Ibrance, Eliquis and Xeljanz, have been well-received in the market, and we believe our late stage pipeline has several attractive commercial opportunities with high potential across several therapeutic areas. We also maintain the financial strength and flexibility to pursue attractive business development and other shareholder friendly capital allocation opportunities." "We plan to make a decision about whether to pursue a potential separation of our innovative and established businesses by no later than the end of 2016, consistent with our original timeframe for the decision prior to the announcement of the potential Allergan transaction," continued Mr Read. "As always, we remain committed to enhancing shareholder value." In connection with the termination of the merger agreement, Pfizer has agreed to pay Allergan $150 million for reimbursement of expenses associated with the transaction. ]]> <![CDATA[US Opioid market to hit $17.7 bn by 2021]]> https://biospectrumindia.com/features/95/3534/us-opioid-market-to-hit-17-7-bn-by-2021.html https://biospectrumindia.com/features/95/3534/us-opioid-market-to-hit-17-7-bn-by-2021.html Wed, 06 Apr 2016 14:55:00 +0530 The company's CBR Pharma report states that this increase will primarily be down to a rising prevalence of chronic pain among the US population, owing to an aging population and an increasing incidence of diabetes, obesity, cardiovascular disorders, arthritis and cancer. Ms Deekshita Allavarapu, Analyst for GBI Research, explains: "Approximately 116 million Americans experienced chronic pain in 2014, which is higher than the incidence of diabetes, heart disorders and cancer combined, and as many as 25 million people experienced moderate to severe pain with significant pain-related activity limitations and diminished quality of life. "For many sufferers, therefore, the prescription and use of opioids such as hydrocodone, oxycodone, fentanyl, or morphine, provides a welcome solution, but brings with it problems associated with substance abuse and dependence, as explored in GBI Research's recent report, 'Substance Abuse Deterrents and Treatments'." The US consumes 80% of the world's legal and illegal opioids. They are highly addictive and the country's most abused prescription drug. Indeed, trends indicate that the use of weak opioids is declining, while the use of strong, more easily abused opioids is increasing. Ms Allavarapu continues: "The FDA has raised concerns over the high use, and the potential for misuse, of opioids. This could lead to the enforcement of regulatory checks that affect the opioid treatment market and its potential growth. "The result of these possible market restrictions, however, is that opportunities may open up for the development of abuse-deterrent opioids and of products that treat or prevent overdoses. Such drugs include Naloxone, which reverses the effect of opioid overdose, Remoxy, a form of controlled-release oxycodone, and Embeda, which combines morphine with an antagonist to reduce the effects of the morphine if necessary." ]]> <![CDATA[Huge opportunities for premium-priced TKIs in PAH]]> https://biospectrumindia.com/features/95/6446/huge-opportunities-for-premium-priced-tkis-in-pah.html https://biospectrumindia.com/features/95/6446/huge-opportunities-for-premium-priced-tkis-in-pah.html Wed, 06 Apr 2016 14:51:14 +0530 The Pulmonary Arterial Hypertension (PAH) space, which is currently burdened by significant unmet need, could benefit substantially from a class of drugs known as Tyrosine Kinase Inhibitors (TKIs), which may aid development of a disease-modifying drug, according to an analyst with research and consulting firm GlobalData. Currently, there are 12 marketed therapies for the treatment of PAH from companies including Actelion, GlaxoSmithKline, United Therapeutics, Bayer, Pfizer, and Gilead Sciences. Dr Lakshmi Dharmarajan, GlobalData's Senior Analyst covering Cardiovascular & Metabolic Disorders, says that manufacturing a drug using TKIs could present a significant opportunity for pharmaceutical companies, with the prospect of commanding a high premium over currently existing treatments, which already range in cost from $50,000-$150,000 per year. Dr Dharmarajan explains: "Previous attempts to develop TKI drugs have met with failure due to the increasing number of concerns regarding the cardiotoxicity of this drug class. For example, Novartis' cancer blockbuster, imatinib, displayed promising outcomes as a PAH therapy up to Phase III of clinical trials, but severe adverse events caused it to be discontinued. "Despite these issues, the future prospects of this drug class in PAH treatment continue to be positive. Of course, further research into this class of drugs could be beneficial, since the mechanism of action of TKIs for PAH has already been proven." The analyst adds that while all of the current drugs for PAH treatment have the potential to reduce disease progression, none of them are capable of reversing the progression of the disease. Dr Dharmarajan continues: "TKIs have successfully demonstrated that they can halt cell proliferation, which is a significantly more promising approach than what is currently offered by the late-stage pipeline drugs. "Indeed, GlobalData believes that focusing on the development of TKI treatments for PAH has the potential not only to produce improved therapies, but also to eventually yield a cure for the disease." ]]> <![CDATA[Aurobindo Pharma receives FDA approval for Polymyxin B for Injection]]> https://biospectrumindia.com/news/95/7926/aurobindo-pharma-receives-fda-approval-for-polymyxin-b-for-injection.html https://biospectrumindia.com/news/95/7926/aurobindo-pharma-receives-fda-approval-for-polymyxin-b-for-injection.html Wed, 06 Apr 2016 10:57:15 +0530 Aurobindo Pharma is pleased to announce that the company has received final approval from the US Food and Drug Administration (USFDA) to manufacture and market Polymyxin B for Injection USP, 500,000 units/vial. This product is expected to be launched in Q2 FY16-17. The approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) Polymyxin B for Injection USP, 500,000 units/vial of Eurohealth International Sarl. Polymyxin B for Injection is an Anti-Infective used in the treatment of infections of the urinary tract, meninges, bloodstream and eye caused by susceptible strains of Pseudomonas aeruginosa. The approved product has an estimated market size of $ 7.6 million for the twelve months ending February 2016 according to IMS. ]]> <![CDATA[Lupin launches Generic Aricept Tablets in the US]]> https://biospectrumindia.com/news/95/4441/lupin-launches-generic-aricept-tablets-in-the-us.html https://biospectrumindia.com/news/95/4441/lupin-launches-generic-aricept-tablets-in-the-us.html Wed, 06 Apr 2016 10:56:01 +0530 Pharma Major Lupin's US subsidiary has launched the first product from its GAVIS pipeline, Zolpidem Sublingual Tablets, 1.75 mg & 3.5 mg to market a generic equivalent of Purdue Pharma L.P's Intermezzo Sublingual Tablets, 1.75 mg & 3.5 mg, having received final approval from the United States Food & Drug Administration (FDA) earlier, as well as final clearance from the FTC with 180 days of exclusivity. Zolpidem Sublingual Tablets, 1.75 mg & 3.5 mg are AB-rated generic equivalent of Purdue Pharma L.P's Intermezzo Sublingual Tablets, 1.75 mg & 3.5 mg and is indicated for use as needed for the treatment of insomnia when a middle-of-the-night awakening is followed by difficulty returning to sleep. Intermezzo had US sales of $9.46 million (IMS MAT December 2015). ]]> <![CDATA[Electronic wearable injector a reality]]> https://biospectrumindia.com/interviews/95/6147/electronic-wearable-injector-a-reality.html https://biospectrumindia.com/interviews/95/6147/electronic-wearable-injector-a-reality.html Tue, 05 Apr 2016 17:30:00 +0530 West's leadership team comprising Ms Karen Flynn and Mr Warwick Bedwell was recently on a business trip to Hyderabad, India. Ms Flynn is West's SVP & CCO, and oversees the company's new global commercial team that includes marketing, sales and contract manufacturing services, and as well as technical customer support for West's full portfolio of offerings. Mr Bedwell serves as VP & MD for West's Asia-Pacific (APAC) region. Ms Flynn revealed that the company is developing new product offerings in the area of generics, having features that will interest generics companies. "We are inculcating some changes in our commercial strategies to become more oriented to various markets we serve. There is a lot of customer similarities around the world in terms of quality standards and wanting reliable supplies. However, there are uniqueness with respect to customer needs. We align ourselves to the market, and get better understanding of the unique market needs, and bring new products and new services specific to the segments," commented Ms Flynn. Crucial Indian Market West's key global market segments include biologics, pharmaceuticals and generics. Mr Bedwell added that India is a key market for the company. "India is important for us not just in the APAC region but globally. We have recognized India's advantage. We are here for the last 10 to 15 years. Our plant in Sri City, Chennai, is close to two years old now, and has been highly successful, catering to India and exports," he said. The facility was completed in 2014 with a cost of $15 million to produce seals used in primary packaging of injectable medicines. In terms of volumes, West expects to touch 1.9 billion pieces by 2019-20 at this facility. As a Chief Commercial Officer, Ms Flynn noted that the visibility of needs in India is not as same as in the Western markets. "There is increase in the regulatory enforcements by USFDA. The quality standards are rising here in the local markets. More and more customers are looking to West for primary packaging components that are pre-washed and pre-sterilized," she expressed. Patient Engagement Trends Globally, patients today are increasingly seen to be wanting to manage their health and well-being themselves. "This is enabled through smart devices that can help them to understand what their sugar levels are, for example, along with medication reminders and controlling of medicine intake. This is addressed through our delivery devices which are electronically connected. For this we have partnered with HealthPrize," Ms Flynn stated. This strategic collaboration was announced in September 2015. HealthPrize is a US-based digital health company in patient engagement and medication adherence solutions. The companies intend to integrate HealthPrize's Software-as-a-Service (SaaS) medication adherence and patient-engagement platform with West's injectable drug delivery systems to provide an end-to-end connected health solution for pharmaceutical companies and patients. West's press release pointed that the combined offering will provide voluntary, electronically-connected drug delivery systems that can track when patients take their medications. HealthPrize's system is also said to engage and educate patients to increase medication adherence and medical literacy, rewarding interaction (gaming theory rewarding system), and stick to prescribed treatment plans leading to favorable outcomes. Trend is also catching up in wanting consistent quality products with fewer side effects, treating patients at home and outside of clinical settings, with wearables becoming more important and delivery systems enabling patients to live a normal life. "Efficient use of the medium is a global trend, and producing products that are more efficient. Producing these products encounter higher costs especially in APAC. Products today are made to fit for purpose when it comes to emerging domestic markets," Ms Flynn opined. Mr Bedwell observed that there is more innovation happening with customers in their applications to reduce costs. "There are looking for smaller footprints in manufacturing and flexible manufacturing systems," he remarked. Crystal Zenith In 2015, West came up with its product Daikyo Crystal Zenith (CZ) in collaboration with its Japanese partner Daikyo Seiko. Crystal Zenith is made of Cyclic Olefin Polymer (CoP) containment and delivery system designed as a high-performance alternative to glass. It is said to be more inert than glass, and solves issues dealing with traditional glass as in breakages, delamination, protein aggregation, or certain reactions. At the moment, 22 to 30 companies in India have used Crystal Zenith. Annually, 2% of West's global sales revenues go into its R&D. "All our R&D happens in our centers located in the US, Europe and Singapore," Mr Bedwell told BioSpectrum. First Gen Wearable Injector Ms Flynn mentioned that West is doing a lot of work in the devices space and primary packaging portfolio. "We are getting ready to commercialize an electronic wearable injector this July," she pointed. This is said to be the first generation electronic wearable injector, and its 8 different embodiments are currently under development. The device, according to the company, has been tested on humans and has undergone clinical trials. Globally, today about 2400 drugs are in development at critical stages.West intends to strengthen its understanding in drug products and primary packaging compatibility. "We want to concentrate and focus on the injectable pharma space, and it is a growing market. The market is large. We have more opportunities in this space to expand. We look for technological opportunities and geographical expansion," Ms Flynn shared. In 2014, West Pharma's Pharmaceutical Packaging Systems business recoded revenues of $1 billion. Its Pharmaceutical Delivery Systems business saw $402 million in revenues. (The writer was flown to Hyderabad, India, by West Pharma to meet its leadership team) ]]> <![CDATA[Rs 100 crore R&D centre launched at Kandla SEZ]]> https://biospectrumindia.com/news/95/6652/rs-100-crore-rd-centre-launched-at-kandla-sez.html https://biospectrumindia.com/news/95/6652/rs-100-crore-rd-centre-launched-at-kandla-sez.html Tue, 05 Apr 2016 11:07:08 +0530 A state-of-the-art R&D centre 'Navin Saxena Research & Technology', Clinical research organization - 'Quest Care' and a specialised manufacturing unit for transdermal patches was launched yesterday at the Kandla Special Economic Zone (SEZ). The facility, owned by parent company Rusan Pharma, is the only one in the country to manufacture Nicotine transdermal patches in India. Rusan Pharma is a fully integrated global pharmaceutical company with interests in Research and Development, Manufacturing and Marketing of formulations, APIs and their intermediates. Set up in alignment with the PM's 'Make In India' initiative, it will go a long way in making the Kandla SEZ vibrant and investor-friendly. The new establishment at Kandla houses three subsidiaries, namely the Navin Saxena Research and Technology (NSRT) Centre, Quest Care which is the company's clinical research organisation and Rusan's dedicated Transdermal Patch Facility. Together, these three units will handle the myriad aspects of addiction and pain management drug manufacture and export as a part of their portfolio, including research and innovation, licensing, IPR, patenting, quality assurance. They offer immense employment opportunities not only to the local population but also to highly qualified scientists from India and abroad. NSRT is a dedicated R&D facility that has state-of-the-art technology and equipment. Research at NSRT will focus on pain, addiction, CNS and orphan diseases, drug delivery and platform technologies. It has been set up with a vision to develop, register and license its new products to third parties. It also aims to undertake contract research and joint development projects. Quest Care (P) is a modern, well-designed, custom-built clinical research organisation (CRO) with five independent clinics having a total of 104 beds. It offers services such as medical writing as per ICH guidelines, bioavailability/bioequivalence and end point studies, and bio-analysis. It is compliant with all regulatory requirements for clinical research. Spread over about 70,000 square feet of area, the CRO incorporates various labs, speciality units and a library of archives. Rusan Pharma being founded in 1994 holds 50% of Indian market share in addiction and 45% in Pain management and 80% of overseas market in addiction (Ukraine / Georgia / Kenya - Addnok range, Mauritius / Myanmar / Thailand - Methadone) and 35% in Pain Management. The company has gone a step ahead and wants to invest in further innovation for new targeted delivery drugs for Breast cancer and Naltrexone implant for Alcohol abuse. Rusan group companies together have a current turnover of Rs 300 cr and intend to grow to Rs 600 crore in 2018. Being the first Indian company to do research on addiction and few orphan disease, they intend to expand their new Rs 100 crore facility by Rs 70-Rs 100 crore in next year. Through this new facility India can enter the innovation drive for the niche categories targeted by NSRT as a participant of $375 million global licensing market. Addressing the media, Dr Navin Saxena, Chairman & Founder of Rusan Pharma, said, "With our continuous efforts and innovation we are proud to announce the biggest government & private Indian company deal between Brazil Health Ministry & Rusan Pharma for $20 million per annum for their program for smoking cessation." He went on to describe the importance of innovation in the present economic climate, where investors want something relevant to today's needs. Transdermal patches, the first to be manufactured indigenously by Rusan in India, fall in that niche. "This facility is the answer to the hunt for new research and medicines by global investors. We invite them to visit us and see it for themselves." Mr Kunal Saxena, Managing Director of Rusan Pharma, "Rusan and NSRT are dedicated to develop and deliver innovative products to the patients. And we are the largest and reputed suppliers of life saving drugs (Buprenorphine, Methadone and anti-TB drugs) to UNODC / UNOPS / Global Fund, MoH - Russia, CIS, South Africa, Kenya, Mauritius, Nepal, Myanmar" Rusan Pharma is one of the few Indian companies that offer a one-stop-shop solution for treating various forms of addictions such as drugs, alcohol and smoking. It is also well known for its pain management products that address the entire spectrum of pain from mild to severe. A pre-inaugural event saw the signing of a memorandum of understanding between NSRT, Moscow State University (Russia), Symbiosis College Pune, The Maharaja Sayajirao University of Baroda and IIT Kanpur. The MOU highlights NSRT's commitment to collaborative research. This would further flare up reverse brain drain for Indian students. ]]> <![CDATA[AZ's Indian GTC sees strong growth ]]> https://biospectrumindia.com/news/95/7939/azs-indian-gtc-sees-strong-growth-.html https://biospectrumindia.com/news/95/7939/azs-indian-gtc-sees-strong-growth-.html Mon, 04 Apr 2016 10:50:43 +0530 This year marks a key milestone in AstraZeneca's journey of setting up India as a global technology delivery hub. The GTC in Chennai is AstraZeneca's first, insourced IT facility globally, delivering significant value to the business through an end-to-end, integrated IT service delivery model. Launched in September 2014, the Chennai Centre was established to improve the IT organization's efficiency and responsiveness in support of 61,500 AstraZeneca employees worldwide. The centre has rapidly insourced IT Applications and Infrastructure Management functions previously outsourced to 8 global vendors. While the journey started with a target of 300 employees in the first year and 1000 in the second year, the early success resulted in an upward revision in scope and scale of the operations. The centre now grown to more than 1,500 qualified IT professionals in 18 months since inception and expects to grow to over 2000 IT professionals by the end of 2016. Mr David Smoley, Chief Information Officer (CIO), AstraZeneca explains, "The new in-house service delivery model has resulted in improved speed of response to the business, increased internal knowledge of critical IT systems, enhanced end-user satisfaction with IT services and significantly reduced costs of IT operations. The GTC staff have a high level of IT experience and expertise, and have been able to make valuable contributions in the very first year of our live operations." The centre has adopted a fully integrated operating model, helping simplify support structures and improve responsiveness to business needs. With Chennai emerging as an IT hotspot with a broad and deep population of IT talent, The GTC has been able to attract talent across all major areas of the IT landscape with the company's emphasis on Technical Leadership and a being a 'Great Place to Work'. Mr Siva Padmanabhan, Head of Chennai Global Technology Center says, "A unique feature of the Chennai centre is that every one of AstraZeneca's major global IT functions is represented here. This enables the company to offer broad career opportunities to our employees. During 2016 the centre will focus a lot on Application Development and Testing, Business Intelligence and Analytics, Mobility and Support of AstraZeneca's Digital Health initiatives". AstraZeneca has adopted a wide range of employee friendly policies and has placed significant emphasis on increasing Gender Diversity in the workplace. This year, the company has also been able to also induct the next generation of IT talent into its workforce through Campus Recruitment efforts across major Engineering Colleges in Chennai. (The above articles is a press release issued by AstraZeneca (AZ)). ]]> <![CDATA[Nicotine, alcohol addiction treatments comprise over 50% substance abuse treatment pipeline]]> https://biospectrumindia.com/features/95/8207/nicotine-alcohol-addiction-treatments-comprise-over-50-substance-abuse-treatment-pipeline.html https://biospectrumindia.com/features/95/8207/nicotine-alcohol-addiction-treatments-comprise-over-50-substance-abuse-treatment-pipeline.html Mon, 04 Apr 2016 10:49:00 +0530 Despite this, there are several promising candidates in development targeting a range of other indications including opioid and cocaine addiction, according to business intelligence provider GBI Research. The company's latest CBR Pharma report states that various new approaches currently under investigation will see novel and first-in-class treatments, including vaccines, redefine the current arena. A growing treatment pipeline and continued research and investment in this field reflects the fact that current therapies for those suffering from various drug addictions remain insufficient. More than 27 million people worldwide are currently classified as problem drug users under the Nations Office on Drugs and Crime's guidelines. Of these, only one in six has access to therapy while many countries still have no adequate services for treating substance abuse. Mr Rodrigo G Gamboa, Managing Analyst for GBI Research, explains: "One of the main reasons why substance abuse remains high and is so difficult to treat is that there is not yet a complete understanding of the various aspects encompassing this global issue. "Several molecular targets have been identified and have furthered drug development, but there are various other targets that are not clearly understood. The poor understanding of the brain mechanisms of addiction represents a significant challenge in terms of developing a highly effective drug, or combination drugs, for treating addiction." Currently, there are 242 companies marketing therapies for substance abuse, and more of these are involved in marketing treatments for alcohol addiction than any other kind. One in every 12 adults suffers from alcohol abuse or dependence in the US, which illustrates the level of demand for these therapies. Mr Gamboa continues: "The competitive landscape is comprised of both large pharmaceutical companies and specialized companies focusing solely on developing substance abuse treatments, with the top eight companies comprising Teva, Allergan, Mylan, Sun Pharma, Sanofi, Psyco Remedies, Rusan Pharma, and Aspen Pharmacare. "Despite the current market focused so heavily on alcohol abuse, there are significant numbers of products in development for the treatment of other addictions and associated withdrawal syndromes. Emerging product segments include cocaine and opioid addictions, with 26 and 21 pipeline drugs, respectively, while the cannabinoids and methamphetamine treatment segments also have several promising drugs in active development." ]]> <![CDATA[Healthcare Sector to reach over $280 bn by 2025: NATHEALTH ]]> https://biospectrumindia.com/news/95/8330/healthcare-sector-to-reach-over-280-bn-by-2025-nathealth-.html https://biospectrumindia.com/news/95/8330/healthcare-sector-to-reach-over-280-bn-by-2025-nathealth-.html Mon, 04 Apr 2016 10:48:22 +0530 NATHEALTH, Healthcare Federation of India, an apex body for the healthcare sector partnered with Deloitte to present imperatives and develop recommendations for actualizing 'Make in India' for the medical devices industry and released 'Code of Ethics' in collaboration with Indian Medical Association (IMA). "The healthcare sector is expected to reach $145 billion by 2018 and over $280 billion by 2025. Though India's healthcare sector has evolved significantly in the last decade, challenges exist in providing access to quality healthcare in the country," said Mr Anjan Bose, secretary general, NATHEALTH. "Lower financing and expenditure on healthcare, inadequate healthcare infrastructure and dual diseases burden are key challenges faced by the sector," added Mr Bose. Medical technology cost in setting up a tertiary care hospital amounts to 30-40 percent. Cost of medical technology/equipment/devices is 20-25 percent of total healthcare cost for a patient. "Given the increasing demand for healthcare and the critical role of medical devices in providing affordable and accessible health, the time is right to align the eco system to view medical devices as a strategic driver. The 'Make in India' initiative is the perfect opportunity to create a step change in Indian healthcare and especially in the medical devices industry," said Ms Charu Sehgal, partner and Life Sciences and Healthcare Leader, Deloitte India. The medical devices market is estimated to grow organically at 15 percent to $8.6 billion by 2020. Though the current domestic medical devices market represents only 1 percent of the global market, India is among the top 20 in the world and among the top 4 in Asia (after China, Japan, South Korea). The medical devices market has grown at 10 percent in the past decade and is expected to have an organic growth of 15 percent in the medium-term against global industry growth of 4 - 5 percent," informed Mr Sushobhan Dasgupta, president, NATHEALTH. Industry estimates that India's medical devices market has the potential to become $50 billion industry by 2025 when the contribution of India to the incremental medical devices industry growth would become substantial at 31 percent. While export of medical devices has been increasing, 'local innovation' by MNCs and domestic manufacturers is expected to drive growth. Medical devices exports have been growing at a CAGR of 12 percent which indicates a promising domestic manufacturing industry, added Mr Dasgupta. As the demand for medical devices increases, India is expected to contribute significantly to the growth of global medical devices industry. MNCs like General Electric, Philips, Medtronic, Siemens etc. have been increasing their manufacturing footprint and research centers in India both for Indian market as well as for exports. Newer markets are opening up due to India-based innovation. USA, Africa, Middle East, China and South East Asia are a few key export destinations from India. India presents a good opportunity for companies to de-risk their business from dependency on one manufacturing location and tap potentially huge domestic market at the same time. Given the criticality of medical devices for growth of the healthcare sector and challenges faced in medical devices manufacturing, it is imperative for the stakeholders in the medical devices and the larger healthcare ecosystem to constructively engage with the Government to facilitate 'Make in India' for the medical devices industry, emphasized Mr Bose. The Government can shape the growth of indigenous manufacturing in its role as a policymaker, development agency and buyer of medical devices. NATHEALTH-Deloitte recommends incentivize medical devices manufacturing - Provide CENVAT/Duty credit on raw materials of medical devices, enable concession duty, VAT parity with imported equipment; facilitate FDA or FDA equivalent certifications for ensuring quality. NATHEALTH asks for separate regulations for medical devices and stresses on state specific incentivization for manufacturing. Trust deficit and unethical practices being a major issue of healthcare industry, NATHEALTH has also developed 'Code of Ethics' in collaboration with Indian Medical Association (IMA) which was released at the event. Ms Preetha Reddy, vice chairperson, Apollo Hospitals and the Champion of the Code of Ethics Initiative at NATHEALH said, "Over the last few decades, our country has witnessed a revolution in medicine. There is a much greater understanding of diagnosis and treatment of diseases, medical care has become lot more accessible and affordable, technology is changing the care paradigm, innumerable lives have been saved, and the noteworthy aspect is that at the core of all this positive progress is the resolute commitment to provide superlative patient care. The private sector has worked with the government to bring in quality standards in the country and now the time is right to bring in a change in the way the private healthcare sector is being perceived. This initiative, a voluntary Code of Ethics initiated by NATHEALTH, a model of self-regulation resonates with this valued goal and it speaks of intent for continuous improvement." Dr KK Aggarwal, Honorary secretary general, IMA explained, "The Code is intended to provide guidance to the members with regards to their conduct and interactions with patients/end users, and other stakeholders so as to ensure that their daily activities, efforts and interactions are undertaken in an ethical, honest manner within the parameters of law for the advancement of healthcare and improved patient care in India." ]]> <![CDATA[Daiichi Sankyo announces closure of its Hiratsuka Plant]]> https://biospectrumindia.com/news/95/8359/daiichi-sankyo-announces-closure-of-its-hiratsuka-plant.html https://biospectrumindia.com/news/95/8359/daiichi-sankyo-announces-closure-of-its-hiratsuka-plant.html Mon, 04 Apr 2016 10:46:19 +0530 Daiichi Sankyo Company, Limited (hereafter Daiichi Sankyo) has announced its decision to close the Hiratsuka plant owned by its subsidiary, Daiichi Sankyo Chemical Pharma Co., Ltd. (hereafter, DSCP). In April 2015, the Daiichi Sankyo Group restructured domestic supply chain subsidiaries, aggregating API production within DSCP to further enhance business operations. Subsequently, a comprehensive assessment toward making API production more efficient and more competitive on a global level led to the decision to close the DSCP Hiratsuka Plant. DSCP Hiratsuka Plant production items will be transferred to other DSCP plants or outsourced. ]]> <![CDATA[Roche to initiate testing for Zika virus at US Blood Centres]]> https://biospectrumindia.com/news/95/6926/roche-to-initiate-testing-for-zika-virus-at-us-blood-centres.html https://biospectrumindia.com/news/95/6926/roche-to-initiate-testing-for-zika-virus-at-us-blood-centres.html Fri, 01 Apr 2016 12:02:00 +0530 Roche has announced that the US Food and Drug Administration (US FDA) has provided approval to initiate collection and testing of blood samples for screening with the cobas Zika assay under an Investigational New Drug Application (IND) protocol. The cobas Zika test for use with the cobas 6800/8800 Systems, is a qualitative in vitro nucleic acid screening test for the direct detection of Zika virus RNA in plasma specimens from individual human blood donors. "The cobas Zika test has been specifically designed utilising the generic cobas omni Utility Channel on the cobas 6800/8800 Systems. These fully-automated high-volume systems provide solutions for blood services to detect the virus and ensure that potentially infected blood units are not made available for transfusion" said Mr Roland Diggelmann, COO Roche Diagnostics. He added, "As a leader in diagnostics, Roche is committed to providing testing solutions for the world's most challenging healthcare emergencies. With the collaboration of the FDA on this IND, we are able to further expand our commitment to help keep the blood supply safe." Initially, the cobas Zika test will be deployed to screen blood donations collected locally in Puerto Rico. It is expected that this testing will enable the reinstatement of the blood services in Puerto Rico and reduce the reliance of blood importation from other areas in the United States. The second stage of deployment for the cobas Zika test will be to prepare for screening of blood donations collected by blood services in the southern United States, which will most likely be impacted by any spread in the virus. Roche continues to work with regulators around the world to determine the path forward to implement the cobas Zika test for blood screening. ]]> <![CDATA[Leave no one behind, make Universal Health Coverage a reality: WHO ]]> https://biospectrumindia.com/news/95/5936/leave-no-one-behind-make-universal-health-coverage-a-reality-who-.html https://biospectrumindia.com/news/95/5936/leave-no-one-behind-make-universal-health-coverage-a-reality-who-.html Fri, 01 Apr 2016 10:59:44 +0530 Countries in the Region need to take urgent and concerted efforts to make Universal Health Coverage a reality and thereby promote wellbeing for all at all ages. "Universal Health Coverage (UHC) means that all people, however rich or poor, and wherever they live, are able to access the health care they need without incurring financial hardship. We must make UHC a reality and ensure that no one is left behind," Dr Poonam Khetrapal Singh, regional director, WHO South-East Asia said at the beginning of a three-day meeting on 'Health, the SDGs and the role of Universal Health Coverage'. At the meeting, health ministers and experts from across the Region are discussing ways to accelerate health coverage and attain the Sustainable Development Goal (SDG) of ensuring healthy lives and promoting wellbeing for all at all ages. Dr Khetrapal Singh emphasized four ways that countries can increase health coverage and progress in their journey toward achieving UHC. "First, access to quality frontline health care is essential. Quality frontline services enhance equity. Second, a well-trained, highly motivated health workforce must be created." "Third, we must reduce out-of-pocket payments. At present out-of-pocket expenditures in the Region account for as much as 70% of all health care spending. This represents a tremendous financial burden for individuals and their families. For many of the poorest it means health care is simply inaccessible." "And fourth, countries must monitor who is not getting access to care and who is being impoverished as a result of health care costs. Enhancing coverage requires reliable information and an in-depth understanding of such gaps and challenges," Dr Khetrapal Singh said. Universal Health Coverage underpins the other SDG health targets and is the means by which they can be attained. Enhancing coverage will help reduce maternal, newborn and child deaths; help end the epidemics of AIDS, TB and malaria as well as hepatitis and other communicable diseases; and enhance access to sexual and reproductive health care services. It will also help tackle new areas of focus in the Region, including alarming rises in non-communicable diseases such as diabetes and hypertension, as well as multi-sectoral issues such as antimicrobial resistance. "The SDGs provide an opportunity - and an obligation - to make further gains in our public health mission. The goals will not be achieved if everyone relies on 'business as usual,'" said Dr Khetrapal Singh. In September 2015, following extensive global consultation, the 193 Member States of the United Nations adopted the SDGs. The SDGs aim to encourage an integrated approach to sustainable development, with a focus on the most vulnerable. ]]> <![CDATA[Dr Reddy's buys rights to investigational anticancer agent from Eisai ]]> https://biospectrumindia.com/news/95/8082/dr-reddys-buys-rights-to-investigational-anticancer-agent-from-eisai-.html https://biospectrumindia.com/news/95/8082/dr-reddys-buys-rights-to-investigational-anticancer-agent-from-eisai-.html Thu, 31 Mar 2016 15:43:14 +0530 Dr Reddy's Laboratories has announced that it has entered into a licensing agreement with Eisai, Japan by which Dr Reddy's will be granted exclusive worldwide development and commercialization rights (excluding Japan and Asia) for Eisai's investigational anticancer agent E7777. Eisai will be responsible for the development and marketing of E7777 in Japan and Asia, while Dr Reddy's holds the option for rights to develop and market the agent in India. In exchange of these rights, Eisai will receive milestone payments in line with obtaining marketing approval and the achievement of agreed upon sales targets. Through this agreement, the two companies aim to accelerate development and maximize the value of E7777. Mr Raghav Chari, executive vice president, Proprietary Products Group, Dr Reddy's Laboratories, said, "The collaboration between DRL and Eisai is a tremendous win-win. E7777 has significant potential as an important component of systemic therapy for CTCL (cutaneous T-cell lymphoma). This therapy represents an extension of our current efforts in the dermatology space to an important segment of skin-related cancers." Mr Terushige Iike, chief product creation officer of Eisai product creation systems, said, "This agreement aligns with Eisai's drive to contribute to patients in our focused field of oncology as quickly as possible. Eisai and Dr Reddy's will conduct development in their respective territories, and by working to accelerate and maximize contribution to patients, we hope to launch treatments that will fulfill the diverse needs of, and bring about benefits for, patients with cancer and their families." ]]> <![CDATA[Zydus receives ANDA approval for Dextroamphetamine IR Tabs]]> https://biospectrumindia.com/news/95/7254/zydus-receives-anda-approval-for-dextroamphetamine-ir-tabs.html https://biospectrumindia.com/news/95/7254/zydus-receives-anda-approval-for-dextroamphetamine-ir-tabs.html Thu, 31 Mar 2016 12:05:50 +0530 Nesher Pharmaceuticals, a subsidiary of Zydus Pharmaceuticals USA has received its first ANDA approval from the USFDA to market Dextroamphetamine IR Tabs. The drug falls in the CNS stimulant segment and is the first product to be developed by the R&D team at Nesher. The drug will be produced at the manufacturing facility based at St. Louis, Missouri, USA. The estimated sales for Dextroamphetamine IR Tabs is $40.6 mn as per IMS. Nesher has considerable expertise in niche therapies which have development or production barriers, such as controlled release medications or DEA-controlled substances, which otherwise cannot be imported ]]> <![CDATA[Aurobindo Pharma receives FDA approval for antibiotic drug]]> https://biospectrumindia.com/news/95/7999/aurobindo-pharma-receives-fda-approval-for-antibiotic-drug.html https://biospectrumindia.com/news/95/7999/aurobindo-pharma-receives-fda-approval-for-antibiotic-drug.html Thu, 31 Mar 2016 12:04:36 +0530 Aurobindo Pharma has announced that the company has received final approval from the US Food and Drug Administration (USFDA) to manufacture and market Vancomycin Hydrochloride for Injection USP, 5 g/vial and 10 g/vial (Pharmacy Bulk Package). This product is expected to be launched in the later part of FY16-17. The approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) Vancomycin Hydrochloride for Injection USP, 5 g/vial and 10 g/vial (Pharmacy Bulk Package), of Fresenius Kabi USA, LLC. Vancomycin Hydrochloride for Injection is an antibiotic used in the treatment of severe infections caused by susceptible strains of methicillin-resistant (Beta-lactam resistant) staphylococci and others. The approved product has an estimated market size of $160 million for the twelve months ending January 2016 according to IMS. ]]> <![CDATA[GSK receives marketing authorization for Nucala in Japan ]]> https://biospectrumindia.com/news/95/7028/gsk-receives-marketing-authorization-for-nucala-in-japan-.html https://biospectrumindia.com/news/95/7028/gsk-receives-marketing-authorization-for-nucala-in-japan-.html Wed, 30 Mar 2016 14:53:46 +0530 GlaxoSmithKline (GSK) has announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) has granted approval for Nucala (mepolizumab) as a treatment for bronchial asthma in patients with refractory asthma whose symptoms are inadequately controlled with standard treatment. Nucala is licensed in Japan for adults and adolescents aged 12 years or older. Nucala is the first medicine in a new class of anti-interleukin-5 (IL-5) biologic therapies. IL-5 plays an important role in regulating the function of eosinophils, inflammatory white blood cells known to be important in asthma. The medicine is administered as a 100 mg fixed dose subcutaneous injection once every four weeks. Patients will receive the treatment in addition to their existing respiratory medication, which comprises high-dose inhaled corticosteroids plus additional medicines, and may include maintenance oral corticosteroids. Approval in Japan comes just four months after the approval of Nucala in the US - the first approval of an anti-IL-5 treatment anywhere in the world. Mr Philippe Fauchet, president, GSK Japan said, "As the market leader in respiratory medicine, GSK has been focused on gaining approval and launching its new respiratory medicines to meet the needs of patients in Japan. Approval of Nucala not only complements our respiratory portfolio but also gives us the opportunity to make a difference to the lives of more patients in Japan. It is our aim to make Nucala available in Japan as soon as possible to support the needs of a significant group of severe asthma patients whose condition is driven by eosinophilic inflammation, which is difficult to control." The MHLW assessment of mepolizumab was based on data from the global clinical development programme, including the pivotal DREAM (MEA112997), MENSA (MEA115588) and SIRIUS (MEA115575) studies, which investigated the efficacy and safety of mepolizumab in patients with severe eosinophilic asthma. All patients in the phase III MENSA and SIRIUS studies had peripheral blood eosinophil levels greater than or equal to 150 cells/Î¼L at initiation of treatment or greater than or equal to 300 cells/Î¼L within the past 12 months. ]]> <![CDATA[Sun Pharma enters Japanese prescription market]]> https://biospectrumindia.com/news/95/6924/sun-pharma-enters-japanese-prescription-market.html https://biospectrumindia.com/news/95/6924/sun-pharma-enters-japanese-prescription-market.html Wed, 30 Mar 2016 11:46:54 +0530 Sun Pharma has announced the acquisition of 14 established prescription brands from Novartis AG and Novartis Pharma AG (together 'Novartis') in Japan. According to the agreements entered into between the parties, a wholly-owned subsidiary of Sun Pharma will acquire the portfolio consisting of 14 established prescription brands from Novartis for a cash consideration of $293 million. These brands have combined annualized revenues of approximately $160 million and address medical conditions across several therapeutic areas. Under the terms of the agreements, Novartis will continue to distribute these brands, for a certain period, pending transfer of all marketing authorizations to Sun Pharma's subsidiary. The acquired brands will be marketed by a reliable and established local marketing partner under the Sun Pharma label. The local marketing partner will also be responsible for distribution of the brands. Commenting on the acquisition, Mr Dilip Shanghvi, managing director, Sun Pharma said, "Japan is a market of strategic interest for us. This acquisition marks Sun Pharma's foray into the Japanese prescription market and provides us an opportunity to build a larger product portfolio in the future." As per the December-2015 IMS Data, the size of the Japanese pharmaceutical market was estimated at $73 Billion, accounting for over seven percent of the $I Trillion global pharmaceutical market. ]]> <![CDATA[Lupin's Mandideep plant comes under FDA scanner]]> https://biospectrumindia.com/news/95/6903/lupins-mandideep-plant-comes-under-fda-scanner.html https://biospectrumindia.com/news/95/6903/lupins-mandideep-plant-comes-under-fda-scanner.html Wed, 30 Mar 2016 11:21:03 +0530 Lupin has received a total of three observations relating to violation of production norms at manufacturing facilities at its Mandideep plant in Madhya Pradesh from the US Food and Drug Administration(USFDA). "We had an audit at our Mandideep location from February 2 to February 19. There were total of three observations. As the site has both dosage form facility and API facility, two separate form 483s were issued with two observations each. one of the observations was repeated in both the forms as it is relevant to both operations," Lupin said in a filing to BSE. "These observations are minor in nature and we have already addressed these observations. We believe that the outcome of the audit will be voluntary action indicated only and there will be no remediation required," it added. The company further said it does not expect any disruption to product supply from Mandideep location. There are no pending applications from the facility. ]]> <![CDATA[Urgent, concerted efforts needed to stem diabetes epidemic: WHO]]> https://biospectrumindia.com/news/95/6489/urgent-concerted-efforts-needed-to-stem-diabetes-epidemic-who.html https://biospectrumindia.com/news/95/6489/urgent-concerted-efforts-needed-to-stem-diabetes-epidemic-who.html Tue, 29 Mar 2016 15:20:42 +0530 World Health Day this year focuses on diabetes and calls for scaling up efforts to prevent, care for and detect the disease to arrest the global epidemic which is hitting the low and middle income countries the most. It celebrated on 7 April every year to mark the anniversary of the founding of WHO in 1948. Each year a theme is selected that highlights a priority area of public health. The Day provides an opportunity for individuals in every community to get involved in activities that can lead to better health. WHO is focusing global attention on diabetes on World Health Day 2016, with the focus in the region on prevent, treat and beat diabetes. Countries in the Region must take vigorous and concerted action to 'prevent, treat and beat' diabetes, a potentially fatal disease that has reached epidemic proportions and is expected to further increase in coming years. "Diabetes rarely makes headlines, and yet it will be the world's seventh largest killer by 2030 unless intense and focused efforts are made by governments, communities and individuals," Dr Poonam Khetrapal Singh, Regional Director, WHO South-East Asia, said ahead of World Health Day which is celebrated on 7 April every year. "Diabetes is of particular concern in the Region. More than one out of every four of the 3.7 million diabetes-related deaths globally occur in the Region, while its prevalence exacerbates difficulties in the control of major infectious diseases such as tuberculosis. Almost half of the 96 million people suffering the disease don't know they have it. If diabetes prevalence continues to rise, the personal, social and economic consequences will deepen," she said. Nearly 90% of all diabetes cases are of Type 2 diabetes, largely the result of excess bodyweight and physical inactivity. It is both preventable and treatable if detected early. If not properly managed the disease causes serious damage to every major organ in the body, resulting in heart attacks, strokes, blindness and nerve damage. "There are individual steps that we can, and must take. Eating healthily and avoiding sugary drinks is a good place to start. We must also control our portion sizes, and ensure they are matched to our energy needs rather than the size of our plate," Dr Khetrapal Singh said. Regular exercise - 30 minutes, and at least five times a week - is necessary for adults to help control weight. Governments must regulate the marketing of food to children, and insist on accurate food labeling to help consumers make decisions that can help them avoid diabetes. Taxing sugary beverages and re-investing the revenue in health promotion activities is an evidence-based intervention that makes real change, she said. Dr Khetrapal Singh said that governments must also increase access to health care and promote educational campaigns regarding self-management and control, as well as making treatment less costly. Diabetes can be managed successfully. It does not have to lead to complications or be fatal, Dr Khetrapal Singh said. Early detection and strict adherence to management strategies is essential to limit diabetes-related complications. ]]> <![CDATA[Sanofi appoints Dr Liu as research head]]> https://biospectrumindia.com/news/95/6475/sanofi-appoints-dr-liu-as-research-head.html https://biospectrumindia.com/news/95/6475/sanofi-appoints-dr-liu-as-research-head.html Tue, 29 Mar 2016 14:22:09 +0530 He will report to Dr Elias Zerhouni, President, Global R&D. Dr Liu is one of the world's most prolific researchers in immunology, with over 94,000 citations (Google Scholar) and more than 250 published articles in top journals such as Nature and Science. His research has led to the development of several key drug targets in the areas of allergy, immunology and oncology. Dr Liu received his doctor of medicine degree in 1984 from Norman Bethune University School of Medicine in China, and earned his doctorate in immunology in 1989 at the University of Birmingham in the UK. Dr Liu will be responsible for leading all of Sanofi's research with the goal of delivering innovative and high-value medicines for patients. He will work in collaboration with Sanofi's Senior Leadership Team to build a competitive R&D organization that leverages the best expertise, both internally and externally. "Sanofi is delivering major therapeutic advances to patients, but in an increasingly competitive landscape it is excellence in science that will shape the medicines of tomorrow. I have great confidence that Yong-Jun will position Sanofi on the leading edge of scientific breakthroughs and drug discovery in the years ahead," said Dr Olivier Brandicourt, Chief Executive Officer, Sanofi. "Yong-Jun will play a pivotal role in shaping a visionary R&D strategy for Sanofi and rejuvenating the company's early-stage pipeline," said Dr Elias Zerhouni, President, Global R&D, Sanofi. "His world-class experience in immunology, oncology and translational medicine will be vital assets as Sanofi sets its sights on scientific excellence and innovation across its therapeutic areas. I am delighted to welcome Yong-Jun to the Sanofi family." Dr Liu has 25 years of experience in the pharmaceutical industry and at leading medical research centers. From 1991 to 1997, he was a Senior and then Principal Scientist at Schering-Plough's Laboratory for Immunological Research. Dr Liu held a Principal Staff Scientist position at the DNAX Research Institute in California until 2002, when he became the founding director of the Cancer Immunology Research Institute at the University of Texas MD Anderson Cancer Center. At MD Anderson, he also served as the Chair of the Department of Immunology, building the leading immunology program in the US. In 2011, Dr Liu joined the Baylor Research Institute as Vice President and Chief Scientific Officer, and Director of the Baylor Institute for Immunology Research. He was appointed Head of Research at MedImmune in January, 2014. ]]> <![CDATA[Glenmark receives two ANDA approvals from the FDA]]> https://biospectrumindia.com/news/95/6476/glenmark-receives-two-anda-approvals-from-the-fda.html https://biospectrumindia.com/news/95/6476/glenmark-receives-two-anda-approvals-from-the-fda.html Tue, 29 Mar 2016 12:09:07 +0530 Glenmark Pharmaceuticals USA (Glenmark) has been granted final approval by the United States Food and Drug Administration (US FDA) for Drospirenone and Ethinyl Estradiol Tablets USP, 3 mg/0.03 mg. Glenmark's products are the generic version of Yasmin Tablets of Bayer HealthCare Pharmaceuticals and for Levonorgestrel Tablet, 1.5 mg, the generic version of Plan B One-Step Tablet of Teva Branded Pharmaceutical Products R&D for over-the-counter (OTC) use as recommended in the submitted labeling. According to IMS Health sales data for the 12 month period ending January 2016, the Yasmin market1 achieved annual sales of approximately $131.7 million. According to IMS Health sales data for the 12 month period ending January 2016, the Plan B One-Step Tablet OTC market1 achieved annual sales of approximately $45.2 million. ]]> <![CDATA[Zydus acquires the gastro therapy 'Actibile' from Albert David ]]> https://biospectrumindia.com/news/95/8137/zydus-acquires-the-gastro-therapy-actibile-from-albert-david-.html https://biospectrumindia.com/news/95/8137/zydus-acquires-the-gastro-therapy-actibile-from-albert-david-.html Tue, 29 Mar 2016 12:08:19 +0530 The Zydus Group, an innovation-led global healthcare provider announced that Zydus Healthcare Limited, a wholly owned subsidiary of Cadila Healthcare Limited has entered into a definitive agreement to acquire "Actibileâ€Ÿ from Albert David Limited (ADL). ADL is listed on the Bombay Stock Exchange and is involved in manufacturing and marketing of branded formulations in India and abroad and also has operations in medical disposables. The brand falls in the gastroenterology segment and is used for dissolving gall bladder stones. The deal will be financed through internal accruals. Speaking on the development, chairman and managing director of the group, Mr Pankaj R Patel said, "The gastrointestinal segment has been one of our core focus segments and we have been working with the medical fraternity to serve patient needs better. I believe that this acquisition will strengthen our portfolio of brands and leverage our equity in this key segment." ]]> <![CDATA[Biocon's Insulin Glargine receives regulatory approval in Japan ]]> https://biospectrumindia.com/news/95/6332/biocons-insulin-glargine-receives-regulatory-approval-in-japan-.html https://biospectrumindia.com/news/95/6332/biocons-insulin-glargine-receives-regulatory-approval-in-japan-.html Mon, 28 Mar 2016 14:35:05 +0530 Biocon Ltd. announced that the Ministry of Health, Labour and Welfare (MHLW) of Japan has approved its biosimilar Insulin Glargine. This is a significant achievement for Biocon and its commercial partner, FUJIFILM Pharma Co. Ltd (FFP). The product is a ready-to-use, prefilled disposable pen with 3 ml of 100IU Insulin Glargine, expected to be launched in Q1 FY17, aiming to capture a significant share of the Japanese Glargine market of $144 Mn, which is the second largest market outside of North America & Europe and is largely dominated by disposable pens. The approval for Insulin Glargine has been obtained post successful completion of initial development by Biocon and local Phase III Clinical Studies in over 250 Type 1 Diabetes patients by our partner in Japan. Biocon's manufacturing facilities for Insulin Glargine, and its disposable pen assembly facility, were inspected and approved by the Japanese regulatory authorities. This pen assembly facility was inaugurated in September 2015 for the launch of Biocon's Insulin Glargine pen branded as 'Basalog One' in India. Biocon Chairperson & Managing Director Kiran Mazumdar-Shaw said: "The Insulin Glargine approval in the highly regulated market like Japan, marks a huge credibility milestone for Biocon. We see this as a significant achievement in our journey of making global impact in diabetes management through our affordable biosimilar insulins. We hope to enable the Japanese government to bring down its healthcare expenditure on diabetes with the use of this cost effective, high quality biosimilar Insulin Glargine." The Per capita spending on pharmaceuticals in Japan is the second highest among OECD countries after the US, and the government is striving to rationalize healthcare spends by encouraging the entry of high quality yet affordable follow-on biologics. This approval will enable Biocon to address the growing needs of diabetes patients in Japan which reported 7.2 million cases in 2015. ]]> <![CDATA[New Bio-Medical Waste Management Rules Notified]]> https://biospectrumindia.com/news/95/5937/new-bio-medical-waste-management-rules-notified.html https://biospectrumindia.com/news/95/5937/new-bio-medical-waste-management-rules-notified.html Mon, 28 Mar 2016 11:47:53 +0530 "The new bio-medical waste management rules will change the way country used to manage this waste earlier. Under the new regime, the coverage has increased and also provides for pre-treatment of lab waste, blood samples, etc. It mandates bar code system for proper control. It has simplified categorization and authorisation. Thus, it will make a big difference to clean India Mission", said Union Minister of State (IC) Environment, Forest & Climate Change, Shri Prakash Javadekar, while releasing the new Bio-medical Waste Management Rules, 2016. The major salient features of BMW Management Rules, 2016 include the following: (a) The ambit of the rules has been expanded to include vaccination camps, blood donation camps, surgical camps or any other healthcare activity; (b) Phase-out the use of chlorinated plastic bags, gloves and blood bags within two years; (c) Pre-treatment of the laboratory waste, microbiological waste, blood samples and blood bags through disinfection sterilisation on-site in the manner as prescribed by WHO or NACO; (d) Provide training to all its health care workers and immunize all health workers regularly; (e) Establish a Bar-Code System for bags or containers containing bio-medical waste for disposal; (f) Report major accidents; (g) Existing incinerators to achieve the standards for retention time in secondary chamber and Dioxin and Furans within two years; (h) Bio-medical waste has been classified in to 4 categories instead 10 to improve the segregation of waste at source; (i) Procedure to get authorisation simplified. Automatic authorisation for bedded hospitals. The validity of authorization synchronized with validity of consent orders for Bedded HCFs. One time Authorisation for Non-bedded HCFs; (j) The new rules prescribe more stringent standards for incinerator to reduce the emission of pollutants in environment; (k) Inclusion of emissions limits for Dioxin and furans; (l) State Government to provide land for setting up common bio-medical waste treatment and disposal facility; (m) No occupier shall establish on-site treatment and disposal facility, if a service of `common bio-medical waste treatment facility is available at a distance of seventy-five kilometer. (n) Operator of a common bio-medical waste treatment and disposal facility to ensure the timely collection of bio-medical waste from the HCFs and assist the HCFs in conduct of training Biomedical waste comprises human & animal anatomical waste, treatment apparatus like needles, syringes and other materials used in health care facilities in the process of treatment and research. This waste is generated during diagnosis, treatment or immunization in hospitals, nursing homes, pathological laboratories, blood bank, etc. Total bio-medical waste generation in the country is 484 TPD from 1,68,869 healthcare facilities (HCF), out of which 447 TPD is treated. Scientific disposal of Biomedical Waste through segregation, collection and treatment in an environmentally sound manner minimizes the adverse impact on health workers and on the environment. The hospitals are required to put in place the mechanisms for effective disposal either directly or through common biomedical waste treatment and disposal facilities. The quantum of waste generated in India is estimated to be 1-2 kg per bed per day in a hospital and 600 gm per day per bed in a clinic. 85 percent of the hospital waste is non-hazardous, 15 percent is infectious/hazardous. Mixing of hazardous results in to contamination and makes the entire waste hazardous. Hence there is necessity to segregate and treat. Improper disposal increases risk of infection; encourages recycling of prohibited disposables and disposed drugs; and develops resistant microorganisms The draft Bio-medical Waste Rules were published in June, 2015 inviting public objections and suggestions. Stakeholders consultation meets were organized in New Delhi, Mumbai and Kolkata. Consultative meetings with relevant Central Ministries, State Governments, State Pollution Control Boards and major Hospitals were also held. The suggestions / objections (about 50) received were examined by the Working Group in Ministry. Based on the recommendations of the Working Group, the Ministry has published the Bio-medical Waste Management Rules, 2016. ]]> <![CDATA[Government launches Rotavirus vaccine as part of Universal Immunization Programme ]]> https://biospectrumindia.com/news/95/6312/government-launches-rotavirus-vaccine-as-part-of-universal-immunization-programme-.html https://biospectrumindia.com/news/95/6312/government-launches-rotavirus-vaccine-as-part-of-universal-immunization-programme-.html Mon, 28 Mar 2016 11:46:02 +0530 "We have achieved a new milestone towards expanding the coverage of full immunization in the country aimed at reducing child mortality". Shri J P Nadda, Union Minister for Health and Family Welfare stated this at the national launch of the Rotavirus vaccine as part of the Universal Immunization Programme (UIP) of the country. Terming this as an historic moment and an exemplary step in India's immunization programme, the Union Health Minister added that the Government is committed to reducing morbidity and mortality in children. Strengthening routine immunization is an essential investment in India's children and will ensure a healthy future of the country, he noted. Noting that Rotavirus is one of the leading causes of severe diarrhoea and death among children less than five years of age, and that every year nearly 80,000 to one lakh children die in the country due to Rotavirus diarrhoea, and about 9 lakh children are admitted to hospital due to episodes of severe diarrhoea with 32.7 lakh cases of OPD, Shri Nadda stated that introduction of Rotavirus vaccine will enable us to directly address the problem of diarrheal deaths. The vaccine is being introduced initially in four states i.e. Andhra Pradesh, Haryana, Himachal Pradesh and Odisha and will be expanded to the entire country in a phased manner. "Adding this life-saving vaccine to our immunization program will not only improve the health of our children but also reduce hospitalization and other conditions associated with diarrhea due to Rotavirus such as malnutrition, delayed physical and mental development among children. Reduced hospitalization reduces the economic burden on the family and the health cost burden on the country", Shri Nadda said. He further stated that the Rotavirus vaccine has been developed indigenously, under a public-private partnership by the Ministry of Science and Ministry of Health and Family Welfare. This therefore is a landmark achievement under 'Make in India' initiative, he stated. Shri Atanu Sabyasachi Nayak, MoS (I/C), Health & Family Welfare, Odisha, congratulated the Health Ministry for introducing Rotavirus vaccine in the UIP. He said that this will have tremendous impact in the health program of the country. He further emphasized the attention to quality by the Odisha Government in all its RCH initiatives. ]]> <![CDATA[Dr Reddy's, XenoPort enter US licensing agreement for XP23829 ]]> https://biospectrumindia.com/news/95/6213/dr-reddys-xenoport-enter-us-licensing-agreement-for-xp23829-.html https://biospectrumindia.com/news/95/6213/dr-reddys-xenoport-enter-us-licensing-agreement-for-xp23829-.html Mon, 28 Mar 2016 10:51:49 +0530 Dr Reddy's Laboratories and XenoPort has announced that they have entered into a license agreement pursuant to which Dr Reddy's Laboratories will be granted exclusive US rights for the development and commercialization of XenoPort's clinical-stage oral new chemical entity, XP23829. Dr Reddy's plans to develop XP23829 as a potential treatment for moderate-to-severe chronic plaque psoriasis and may potentially develop XP23829 for relapsing forms of multiple sclerosis (MS). Under the terms of the agreement, Dr Reddy's will receive exclusive US rights to develop and commercialize XP23829 for all indications. In exchange for these rights, XenoPort will receive a $47.5 million up-front payment and an additional $2.5 million for transfer of certain clinical trial materials to Dr Reddy's Laboratories. XenoPort will also be eligible to receive up to $190 million upon the achievement by Dr Reddy's of certain regulatory milestones, which could be achieved over a period of several years. In addition, XenoPort will be eligible to receive up to $250 million upon the achievement of commercial milestones, and up to mid-teens royalty payments based on potential net sales of XP23829 in the United States. Dr Mark Jackson, clinical professor of medicine, Dermatology, University of Louisville, stated, "Based on today's available treatments, physicians need additional oral medications that are both safe and effective for patients with psoriasis. Fumaric acid esters possess a unique anti-inflammatory mechanism of action and have been used to treat psoriasis in Germany for over 20 years. XP23829, a novel fumaric acid ester, has the potential to be a meaningful treatment option for patients with moderate-to-severe psoriasis." "XP23829 complements our internal development efforts, which have primarily focused on the mild-to-moderate psoriasis segment to date. In other markets, fumarates have been used as first line choices of treatment prior to initiation of biologic therapies in patients with moderate-to-severe psoriasis. We intend to initiate the registration program for XP23829 as soon as feasible so that we can accelerate the availability of this important treatment choice for moderate-to-severe psoriasis patients in the U.S. market," said Mr Raghav Chari, executive vice president, Proprietary Products Group, Dr Reddy's Laboratories. "We are very pleased to announce this agreement with Dr Reddy's Laboratories," said Mr Vincent J Angotti, chief executive officer, XenoPort. "As one of our key objectives for 2016, we were interested in finding a strong partner that would recognize the opportunity of this innovative therapy that we believe will make a significant difference in the lives of psoriasis and MS patients. We are now fully focused on our HORIZANT (gabapentin enacarbil) Extended-Release Tablets commercialization effort." The agreement is subject to review by the US Government under the Hart-Scott-Rodino (HSR) Antitrust Improvements Act, as amended, and will become effective only after clearing HSR review. ]]> <![CDATA[New products poised for battle in European Hemophilia B market]]> https://biospectrumindia.com/features/95/7118/new-products-poised-for-battle-in-european-hemophilia-b-market.html https://biospectrumindia.com/features/95/7118/new-products-poised-for-battle-in-european-hemophilia-b-market.html Thu, 24 Mar 2016 14:15:50 +0530 Two new products for the treatment of hemophilia B, CSL Behring's Idelvion and Sobi/Biogen's Alprolix, will compete intensely for market share following their expected European approvals in April 2016, according to an analyst with research and consulting firm GlobalData. While Idelvion had a three-month head-start over Alprolix in the European Medicines Agency's review process, Alprolix managed to catch up and obtained a recommendation from the Committee for Medicinal Products for Human Use at the same time as Idelvion. Dr Fenix Leung, GlobalData's Senior Analyst covering Oncology and Hematology, states that as the efficacy and safety of both Idelvion and Alprolix are considered to be very similar according to key opinion leaders interviewed by GlobalData, the time to market will be a key differentiator in determining the success of a drug in the hemophilia B market. Dr Leung comments: "It is currently unclear whether Sobi or CSL Behring will manage to launch their respective long-acting recombinant Factor IX treatments first, as both drugs are expected to gain marketing approval at the same time. "Sobi's advantages lie in the fact that Alprolix is already approved outside of the EU, and Biogen has manufacturing facilities in place to produce the drug and transport it to the EU, where Sobi will be responsible for the drug's packaging and distribution. "Idelvion, however, has certain clinical and commercial advantages over Alprolix that could help the drug to overcome Sobi's strong points, as it can be dosed every two weeks as opposed to every 10 days." The analyst adds that CSL Behring also has a clear advantage over Sobi in terms of marketing, as it has a considerable presence in the European hemophilia market with its plasma-derived and recombinant coagulation factors, backed up by a strong sales force. "Overall, although Alprolix managed to catch up to Idelvion in gaining marketing authorization in the EU, GlobalData believes that Idelvion's prolonged dosing interval and CSL Behring's marketing experience may still help the drug to secure a leading position in the hemophilia B market," Leung concludes. ]]> <![CDATA[GE Healthcare partners with Imbio]]> https://biospectrumindia.com/news/95/7087/ge-healthcare-partners-with-imbio.html https://biospectrumindia.com/news/95/7087/ge-healthcare-partners-with-imbio.html Thu, 24 Mar 2016 11:37:22 +0530 Imbio, a leader in fully automated, biomarker-based solutions for quantitative Lung imaging, and GE Healthcare have announced a collaboration to make Imbio's Lung Density Analysis, a volumetric imaging solution for Lung CT, one of the first software applications to be available in the GE Health Cloud. As a result of this collaboration, Lung Density Analysis (LDA), Imbio's FDA cleared and CE marked software for quantification and visualization of COPD components, will be fully integrated into GE Health Cloud's clinical workflow. Customers subscribing to LDA through GE Health Cloud will have their CT lung images automatically uploaded for processing with LDA, to receive both an augmented CT lung series with density overlays for detailed image interpretation, as well as patient-friendly summary reports added to their study results. The full workflow integration will enable streamlined processing to quantify and localize areas of low lung density and air trapping, providing physicians with fast, secure and seamless clinical information to help deliver better patient care. This agreement marks the first step in integrating Imbio's portfolio of lung analysis solutions into the GE Health Cloud. "At Imbio, we are working to break down the barriers to broader use of clinically valuable quantitative imaging," commented Dr Cynthia Maier, Imbio's CEO. "Partnering with GE to bring Lung Density Analysis to the GE Health Cloud is directly aligned with our focus on fully-automated applications to improve productivity, while making richer, personalized patient analysis accessible to all physicians to aid their diagnosis and care planning." "This partnership with Imbio confirms our commitment to providing healthcare professionals with enhanced quantifiable clinical insights. By incorporating Imbio's personalized lung analysis into GE Healthcare's cloud-enabled workflow solutions, we are enriching the data that we can provide through the GE Health Cloud," said Mr Evren Eryurek, software chief technology officer for GE Healthcare. Lung Density Analysis is expected to be released on the GE Health Cloud when it launches in mid-2016. ]]> <![CDATA[Vijay Mallya steps down as board chairman of Sanofi India]]> https://biospectrumindia.com/news/95/6880/vijay-mallya-steps-down-as-board-chairman-of-sanofi-india.html https://biospectrumindia.com/news/95/6880/vijay-mallya-steps-down-as-board-chairman-of-sanofi-india.html Thu, 24 Mar 2016 11:09:15 +0530 Sanofi India Limited (SIL) has announced that its Chairman of the Board of Directors, Dr Vijay Mallya has conveyed his decision to not seek re-election as a Director at the ensuing Annual General Meeting (AGM). He became a Director of the Company (then called Hoechst Pharmaceuticals Limited) in December 1973 and has been Chairman of the Board since December 1983. Dr Mallya, in his message to the SIL Board of Directors, stated, "I have been privileged to preside over the Board of this Company, which started as Hoechst Pharmaceuticals Ltd. and to have participated in its phenomenal growth and prosperity over such an extraordinarily long period of time." He further added, "Today, Sanofi India Limited is not only financially strong but with an impeccable track record. It is gratifying to me that the Company continues to serve needy patients in India with world-class medication whilst ensuring consistent returns to all stakeholders." Dr Shailesh Ayyangar, managing director - SIL stated, "The Board of Directors while accepting Dr Mallya's decision, placed on record its deep appreciation of his exceptional service and leadership, firstly as a Director and subsequently as Chairman of the Board for over four decades." The Board of Directors has recommended to the shareholders that resolutions be passed at the ensuing Annual General Meeting to elect two new Independent Directors to the Board - Mr Aditya Narayan and Ms Usha Thorat, for a term of five years , from 30th April 2016. Mr Aditya Narayan, 64, has rich experience in industry for over 40 years. He served ICI Limited, now Akzo Nobel India Limited, for about 30 years across diverse functions and businesses. He was its Managing Director during 1996-2003 and then its non executive Chairman over 2003 - 2010. Over 2005-2009, he was the President and CEO of BHP Billiton India. He has also served as an Independent Director on a number of Boards. Presently, he is an Independent Director of Hindustan Unilever Limited since 2001, Linde India Limited since 2012 and Chambal Fertilizers and Chemicals Limited since 2015. The SIL Board announced that it was its intention to appoint Aditya Narayan as the next Chairman of the Board of Directors, subject to his election as an Independent Director at the ensuing Annual General Meeting, and subject to the compliances laid down in the Articles of Association of the Company, the Companies Act, 2013 and the rules framed thereunder. Ms Usha Thorat, 66, joined the Reserve Bank of India (RBI) in 1972 after a Masters in Economics from Delhi School of Economics. She became Deputy Governor in 2005 and remained in this position till 2010. After stepping down from RBI, Ms Usha Thorat was entrusted by the RBI to set up the Centre for Advanced Financial Research and Learning (CAFRAL) in banking and finance. She held charge as Director of CAFRAL from 2011 to 2014. Currently, she is Chairperson of the Clearing Corporation of India Ltd. and also Chairperson of the Financial Benchmarks India (Pvt.) Ltd., both financial markets infrastructure companies. ]]> <![CDATA[Sun Pharma, AstraZeneca India enter partnership in Type 2 diabetes ]]> https://biospectrumindia.com/news/95/4356/sun-pharma-astrazeneca-india-enter-partnership-in-type-2-diabetes-.html https://biospectrumindia.com/news/95/4356/sun-pharma-astrazeneca-india-enter-partnership-in-type-2-diabetes-.html Wed, 23 Mar 2016 16:43:08 +0530 AstraZeneca Pharma India and Sun Pharma has announced a partnership for the distribution of dapagliflozin, an innovative Type 2 diabetes medicine, in India. Dapagliflozin is AstraZeneca India's leading diabetes medicine. Under the agreement, Sun Pharma will promote and distribute dapagliflozin under the brand name "Oxra". AstraZeneca India markets dapagliflozin under the brand name Forxiga and under the terms of the agreement, both companies will promote, market and distribute dapagliflozin in India under different brand names. AstraZeneca will retain the intellectual property rights to dapagliflozin. Sun Pharma will also gain the rights to promote and distribute the combination of dapagliflozin with metformin under the brand name "Oxramet", following regulatory approval. AstraZeneca India is currently seeking approval from the Drug Controller General of India for the combination of dapagliflozin with metformin Commenting on the agreement with AstraZeneca India, Mr Abhay Gandhi, CEO - India Business, Sun Pharma said, "This agreement for dapagliflozin further strengthens our partnership with AstraZeneca India. The addition of this innovative Type 2 diabetes treatment bolsters our diabetes portfolio. We believe the extended portfolio will further enhance our service capabilities to offer customers & patients innovative medicines at affordable prices. Sun Pharma enjoys a strong relationship with the physician community, especially diabetologists, endocrinologists and consulting physicians treating patients with diabetes across India. Through this partnership with AstraZeneca, access to dapagliflozin will be enhanced for doctors & Type 2 diabetes patients in India." Commenting on the agreement, Mr Sanjay Murdeshwar, managing director, AstraZeneca India stated, "AstraZeneca is committed to addressing unmet need in the treatment of Type 2 diabetes by offering treatment options to physicians that meet the needs of individual patients. Dapagliflozin represents a significant advancement in the treatment of Type 2 diabetes and this agreement supports our strategy of working with a local partner to maximize the value from our innovative medicines in a key emerging market. It ensures a greater number of patients will have access to this important treatment option." Diabetes (all types) is estimated to affect approximately 69.2 million people in India and more than 415 million people worldwide. By 2040, this will rise to 642 million and Type 2 is the most common form of diabetes. The size of the overall Indian diabetes treatment market is more than Rs. 8400 crore (this includes Type1 and Type 2), growing at approximately 21 percent year-on-year. ]]> <![CDATA[APAC's Alzheimer's market to surpass $5 bn by 2021]]> https://biospectrumindia.com/features/95/7157/apacs-alzheimers-market-to-surpass-5-bn-by-2021.html https://biospectrumindia.com/features/95/7157/apacs-alzheimers-market-to-surpass-5-bn-by-2021.html Wed, 23 Mar 2016 14:25:10 +0530 The Asia-Pacific (APAC) Alzheimer's disease market will grow from $3 billion in 2014 to $5.1 billion in 2021, representing a robust Compound Annual Growth Rate of 7.9%, according to business intelligence provider GBI Research. The company's latest report states that the main driver of this impressive growth, which will occur across the APAC countries of India, China, Australia and Japan, will be rising and aging populations, as Alzheimer's disease is significantly more prevalent among the elderly. Additional market drivers include better diagnostic techniques, improving health awareness, special healthcare programs, health insurance coverage, and increasing treatment affordability. Ms Gayathri Kanika, Analyst for GBI Research, says: "An example of healthcare reforms is the Japanese government's recently approved plan to increase the number of nurses and care workers in the country's healthcare system by 2025, in order to help patients access and interpret information about their health, thereby improving knowledge and diagnoses of Alzheimer's. "Across the APAC region, the expansion of health insurance coverage will increase access to healthcare, also leading to a rise in Alzheimer's diagnosis and higher treatment rates." In terms of the current Alzheimer's pipeline, there are a number of late-stage products with the potential to be approved and launched in APAC countries during the forecast period. These include first-in-class Beta-site Amyloid precursor protein Cleaving Enzyme (BACE)1 inhibitors and passive immunotherapies. Ms Gayathri explains: "Three important anti-beta Amyloid (AÎ²) drugs are Roche's gantenerumab, TauRX Therapeutics' LMTX and Merck's MK-8931 (verubecestat), which are in Phase III development in Australia and Japan, and will capture significant market share in these countries after they are launched late in the forecast period. "Acetylcholinesterase Inhibitors (AChEIs), such as Eisai's Aricept (donepezil), Novartis' Exelon (rivastigmine) and Janssen's Razadyne (galantamine), will also continue to capture major patient share across all Alzheimer's sub-populations in the four APAC countries." Despite the success of these treatments, GBI Research states that significant unmet needs will remain for Alzheimer's patients as there are only a few disease modifying therapies in the late stage pipeline, with currently available therapies only able to treat symptoms of the disease rather than preventing or slowing its progression. ]]> <![CDATA[TB programs be given special place in health sector: WHO]]> https://biospectrumindia.com/news/95/8257/tb-programs-be-given-special-place-in-health-sector-who.html https://biospectrumindia.com/news/95/8257/tb-programs-be-given-special-place-in-health-sector-who.html Wed, 23 Mar 2016 12:48:57 +0530 The South-East Asia Region has achieved the 2015 Millennium Development Goal of halting and reversing TB incidence, said WHO Regional Director for South-East Asia, Dr Poonam Khetrapal. The Region has also achieved the Stop TB Partnership's target of halving the TB mortality and prevalence rates compared to 1990 levels. "Access to TB care has expanded substantially. Almost 22 million TB patients have been treated in the past 10 years. Treatment success rates among new smear positive pulmonary TB cases have remained above 85% since 2005, and were at a high of 88% in 2013," she added. However, Dr Poonam stresses that this is not enough. "Recognizing that these gains are inadequate is essential to pursuing bold new policies to accelerate progress. Current trends clearly show that without such policies and approaches, the SEA region, including India, will fail to meet the SDG targets to End TB by 2030. In a Region with a high TB burden and high at-risk populations, we must think out of the box to find innovative ways to tackle the problem of TB," she explains. Bold policies come in many shapes and forms. She points, "I suggest the following four ways to move ahead. "First, alongside providing integrated, patient-centered care and prevention, achieving Universal Health Coverage is a priority. Universal Health Coverage also allows the opportunity to implement more robust regulatory frameworks for case notification, vital registration, and rational use of medicines. "Second, we must address the social determinants of TB. Addressing poverty and other determinants will have a dramatic effect on the disease's burden. Policies in this regard could include increasing access to safe housing and providing viable social security among other options. "Third, to End TB we must reach out to and engage with communities directly. Overcoming stigma, increasing awareness, and obtaining community buy-in at the grassroots is as valuable as any assemblage of experts and policymakers. Forging partnerships with civil society groups and between public and private care providers will likewise ensure that present gaps are closed, and that a society-wide movement to End TB develops. "And fourth, political commitment at the highest level, which is already strong, must be reinforced. The mission-like zeal with which polio and HIV/AIDS have been fought must be reproduced in the battle against TB, and must lead to organizational and programming shifts. TB programs must be given a special place within the health sector; structural and operational efficiencies maximized so that a strong, efficient and effective control programme exist in every country. "Finally, we must not forget that along with political commitment and a strong programme, effective resource mobilization is essential to accelerate and sustain TB control activities." The funding required for a full response to the global TB epidemic in low- and middle-income countries was estimated at USD 8 billion per year in 2015. This figure excludes research and development. Based on reporting by countries, in 2015 USD 6.6 billion was available for TB prevention, diagnosis and treatment, leaving a funding gap of USD 1.4 billion. International donor funding dominates in low-income countries. To bridge the funding gap, both domestic and international funding needs to be enhanced. ]]> <![CDATA[Glenmark gets FDA nod for Raloxifene Hydrochloride Tablets]]> https://biospectrumindia.com/news/95/7253/glenmark-gets-fda-nod-for-raloxifene-hydrochloride-tablets.html https://biospectrumindia.com/news/95/7253/glenmark-gets-fda-nod-for-raloxifene-hydrochloride-tablets.html Wed, 23 Mar 2016 11:38:20 +0530 Glenmark Pharmaceuticals USA (Glenmark) has been granted final approval by the United States Food and Drug Administration (US FDA) for Raloxifene Hydrochloride Tablets USP, 60 mg, the therapeutic equivalent to the reference listed drug product, Evista Tablets, 60 mg, of Eli Lilly and Company. According to IMS Health sales data for the 12 month period ending January 2016, the Evista Market achieved annual sales of approximately $336.5 million. "Increased risk of deep vein thrombosis and pulmonary embolism have been reported with raloxifene hydrochloride. Women with active or past history of venous thromboembolism should not take raloxifene hydrochloride," Glenmark said in a warning, statement. "Increased risk of death due to stroke occurred in a trial in postmenopausal women with documented coronary heart disease or at increased risk for major coronary events. Consider risk-benefit balance in women at risk for stroke," the company added. ]]> <![CDATA[Sartorius introduces assays for testing biosimilarity of three leading biologics]]> https://biospectrumindia.com/news/95/8150/sartorius-introduces-assays-for-testing-biosimilarity-of-three-leading-biologics.html https://biospectrumindia.com/news/95/8150/sartorius-introduces-assays-for-testing-biosimilarity-of-three-leading-biologics.html Wed, 23 Mar 2016 11:37:14 +0530 The new assays, launched by SSB's subsidiary Sartorius Stedim BioOutsource, will allow biopharma manufacturers to generate accurate comparability results rapidly and cost-effectively. Utilizing its extensive expertise in the development, optimisation and qualification of a wide range of different types of binding assays and immunoassays, the ready-to-use assays have been developed to ensure accurate comparability results for biosimilars to Actemra, Stelara and Lucentis. The new assays available include: Actemra IL-6R neutralization Bioassays; an Actemra IL-6R Binding ELISA; Stelara IL-12/IL-23 Binding Assays; a Stelara C1q Binding Assay; a Stelara neutralization bioassay; Lucentis VEGF Binding Assays and a Lucentis VEGF neutralization Bioassay. These pre-developed assays complement BioOutsource's existing portfolio of assays and expands the number of molecules the company can now support to more than nine molecules. The availability of pre-qualified off-the-shelf assays provides biosimilar developers the opportunity to quickly and cost effectively test a wide range of biosimilars utilising assays from just one trusted supplier. Additionally, as BioOutsource has its own in-house R&D department, it is continually adding to its portfolio of assays. Therefore, if an assay is not listed, scientists can contact the firm to discuss its availability, or use the company's expert services to configure an assay to meet their specific requirements. Dr Daniel Galbraith, chief scientific officer of Sartorius Stedim BioOutsource stated, "We're delighted to bring new assays for testing Actemra, Stelara and Lucentis biosimilars to market. This means we can now offer biopharma companies a comprehensive range of ready-to-use assays, which they can trust to determine precise comparability results and accelerate their biosimilar drug development." ]]> <![CDATA[PM Modi urged to launch â€œRashtriya Swachh Injections Abhiyan"]]> https://biospectrumindia.com/news/95/3938/pm-modi-urged-to-launch-rashtriya-swachh-injections-abhiyan.html https://biospectrumindia.com/news/95/3938/pm-modi-urged-to-launch-rashtriya-swachh-injections-abhiyan.html Tue, 22 Mar 2016 16:54:38 +0530 SAFE POINT INDIA, India's leading voluntary organization working towards enhanced patient and health worker's safety and to bring down overall healthcare cost through safe injection practices, has urged Prime Minister Narendra Modi to launch a nationwide "Rashtriya Swachh Injections Abhiyan" to end the continued practice of unsafe injections which result in avoidable loss of life, serious health risks and increased healthcare burden. "We wish to draw the attention of Prime Minister Shri Narendra Modi Ji towards the menace of unsafe injection practices and sincerely urge him to use his good office to launch 'Rashtriya Swachh Injections Abhiyan', said Mr Rajiv Nath, Project Director & Trustee, and Safe Point India. Explaining the urgent need for such a nationwide programme, Mr Nath pointed out that "Injections should be life giver, not life taker but unsafe injection practices, mostly in the form of reuse of safety injections from dirty contaminated needles, continues to be a serious threat to life of patients and health workers, casting shadows over public healthcare and immunization programme while raising individual and national healthcare cost burden." Mr Nath added that such a campaign would be relatively lower cost but concomitant benefits in terms of health, safety and hidden savings in saving lives or loss from income due to extra days on a hospital bed or taxpayers money in treatment costs, would be humungous. Studies and common medical observations have found that unsafe injections can result in the transmission of blood-borne pathogens from patient to patient (through reuse of syringes); patient to healthcare worker (through needle-stick injuries) and at times from health worker to patient. The community at large is also at risk when used injection equipment is not safely disposed of. Unsafe injection practices have also been the cause of outbreaks of viral hepatitis B and C and HIV in healthcare settings including in high income countries. The threat resulting from unsafe injection practices in India is real and widespread due to inadequate laws, lax regulation as well as low awareness among countryside. The Safe Injection campaign would be all the more relevant as recently the WHO Director General, Dr Margaret Chan called out for WHO's 3rd Public Healthcare initiative viz. Injection Safety through deployment of Smart Auto Disable Syringes in all developing countries by 2020 and the need for partnership between all stakeholders in public and private sector to achieve this. (The first two initiatives were eradication of Polio & Hand Washing). India has been chosen to be one of the three 'Pilot Countries' along with Egypt and Uganda to launch the WHO's Injection Safety Initiative. All donors had been urged to fund procurement of only safety engineered injection devices which prevent reuse and don't lead to accidental needle stick injuries among healthcare workers and provide funding for ancillary needs including appropriate quantities of single dose diluents and safety boxes, sharps waste management and health worker training. According to a WHO study, for every 1$ invested in injection safety, savings are to the tune of over 14 $ in hidden cost of public healthcare spending for treatment of ailments. This is substantial and to correlate one can compare with another WHO study - every 1$ invested in immunisation has been resulting in 16$ savings to a Nation. Prevention is far less cost than Cure. Mr Nath believes Andhra Pradesh as a pilot state would be ideal to start this Clean Injection- Swach Injection campaign as they received encouraging response from AP CM Shri Chandra Babu Naidu and his Health Dept. on this. According to WHO, every year over 16 billion injections are administered worldwide in developing world. India alone has over 4 billion injections currently per annum. The vast majority - around 90 percent - are given in curative care. Immunization accounts for around 5 to 10 percent of all injections where AD syringes are already deployed while the remaining indications include transfusion of blood and blood products, intravenous and intramuscular administration of drugs and fluids and administration of injectable contraceptives. Backgrounder on Safe Injection Practices in India (Laws, regulations & practices): Injection Safety was universally introduced into the Immunization Campaign in India in 2006 nearly a decade ago when in 2005 an India Clen Report financed by World Bank highlighted nearly 2/3rd of injections as unsafe and risk of infections from re-use. In December 2008, Dr Ramadoss then Union Minister of Health sent an advisory to all CGHS hospitals to start using AD Syringes for curative injections (which are nearly 80 percent of the injections), by April 2009 and requested all State Health Ministers to similarly follow. But the impetus died after he left. Thereafter, in August 2014 the Health Secretary Shri Luv Verma released an Injection Safety Handbook. In December 2014, the National Health Systems Resource Centre released a HTA (Health Technology Assessment) on AD Syringes and recommended its usage to address infections from injections. ]]> <![CDATA[POC diagnostics market to rise to $3 bn by 2021]]> https://biospectrumindia.com/features/95/3063/poc-diagnostics-market-to-rise-to-3-bn-by-2021.html https://biospectrumindia.com/features/95/3063/poc-diagnostics-market-to-rise-to-3-bn-by-2021.html Tue, 22 Mar 2016 16:54:00 +0530 The point of care (POC) diagnostics market will experience solid growth from $2.13 billion in 2015 to just under $3 billion by 2021, representing a Compound Annual Growth Rate (CAGR) of 5.3%, according to research and consulting firm GlobalData. The company's latest report states that such growth, which will occur across the 10 major markets (10MM) of the US, France, Germany, Italy, Spain, the UK, Japan, China, India, and Brazil, will be driven by a number of factors, including the increasing prevalence of lifestyle-related and infectious diseases. Other market drivers include the increasing adoption of cardiac markers in emergency departments, the growing home-testing market, and the potential for POC devices to accelerate patient care decision-making and reduce overall hospital lengths of stay. Ms Wenlu Hu, GlobalData's Analyst covering Medical Devices, says: "Particularly important in the growth of the POC market is the emergence of more accurate molecular POC technologies for infectious disease testing. "GlobalData forecasts that the market for cardiac markers POC tests, which can assist with the diagnosis of conditions such as acute coronary syndrome, will reach $507.5 million by 2021, due to the tests' ability to shorten emergency department stays, allowing for faster discharge of patients and reduced costs." Beyond hospitals and healthcare facilities, home-testing medical devices are also on the rise, as the penetration and expansion of POC tests into the over-the-counter (OTC) consumer market is substantially driving market growth. Ms Hu explains: "The adoption of these tests began when technologies were first being developed to allow diabetics to monitor their blood glucose levels using simple handheld meters. Many new tests are available in OTC formats, including meters for anticoagulation monitoring, urine pregnancy tests, and fertility tests. "In line with the OTC pharmaceutical market, the trend towards POC home testing will most likely continue to expand, possibly into areas such as concussions, reflecting a greater awareness of consumerism in the laboratory testing market." ]]> <![CDATA[ARIAD appoints new EVP]]> https://biospectrumindia.com/news/95/8395/ariad-appoints-new-evp.html https://biospectrumindia.com/news/95/8395/ariad-appoints-new-evp.html Tue, 22 Mar 2016 16:51:02 +0530 ARIAD Pharmaceuticals announced the appointment of Mr Manmeet Soni, 38, as executive vice president, chief financial officer and treasurer, effective March 21, 2016. He will report to Mr Paris Panayiotopoulos, president and chief executive officer of ARIAD. Mr Soni will succeed Mr Edward M Fitzgerald, who has made significant contributions to the company as ARIAD's chief financial officer since 2002. Mr Fitzgerald will work closely with Mr Soni to ensure a seamless transition. ]]> <![CDATA[J P Nadda launches new initiatives to combat TB ]]> https://biospectrumindia.com/news/95/4367/j-p-nadda-launches-new-initiatives-to-combat-tb-.html https://biospectrumindia.com/news/95/4367/j-p-nadda-launches-new-initiatives-to-combat-tb-.html Tue, 22 Mar 2016 13:01:17 +0530 "The Government of India stands committed to accelerating its efforts to combat tuberculosis in the country", stated Shri J P Nadda, Union Minister of Health and Family Welfare. He was speaking on the eve of 'World TB Day', on March 21,2016. He stated that the process of fighting TB is continuous, hence there can be no dilution and do diversion. Our attention needs to steadfast and aggressive, stated the Health Minister. He further added that resources will not be a constraint and the Government will continue to work with all stakeholders, in devising short term and long term approaches. Shri Nadda also emphasized the need for compassion in the treatment of TB patients. At the event, Shri J P Nadda, launched Bedaquiline - new anti-TB drug for Drug Resistant TB as part of the RNTCP. The drug is a new anti-TB drug for treatment of MDR-TB. This new class of drug is a diarylquinoline that specifically targets Mycobacterial ATP synthase, an enzyme essential for supply of energy to Mycobacterium tuberculosis and most other mycobacteria. This drug is indicated for use in the treatment of drug-resistant TB. Bedaquiline is being introduced at six identified tertiary care centres across India. These sites have advanced facilities for laboratory testing and intensive care for patients. Bedaquiline will be given to multi-drug resistant TB patients with resistance to either all fluoroquinolone and/or all second line injectables and extensive drug resistant TB. Shri Nadda also inducted over 500 Cartridge Based Nucleic Acid Amplification Test (CBNAAT) machines in the programme. The CBNAAT is a revolutionary rapid molecular test which detects Mycobacterium tuberculosis and rifampicin drug resistance, simultaneously. This test is fully automated and provides results within two hours. It is a highly sensitive diagnostic tool and can be used in remote and rural areas without sophisticated infrastructure or specialized training. Until 2015, 121 CBNAAT sites are functional in the country largely providing decentralized testing for detection of DR TB. With the availability of these additional 500 machines, access to rapid quality assured diagnosis of DR TB and TB will be ensured in all the districts of India either directly or through a linkage by specimen transport mechanism. Additionally, the programme will be able to use this highly sensitive state-of-art technology for diagnosis of TB among key populations like children, PLHIV and extra pulmonary TB patients. The Health Minister also released the TB India 2016 Annual Report and the Technical and Operational Guidelines for TB Control in India 2016. The comprehensive set of guidelines are for management of all forms of TB, including drug resistant TB and strategies for intensified case finding; adherence of more patient centric approaches; and single-window care for patients suffering from HIV and TB. A handbook for 'Healthcare Worker surveillance for TB in India' and Guidelines for Prevention and Management of Adverse reactions associated with anti-TB drugs were the other e-book launch at the event. A new radio campaign with TB ambassador Amitabh Bachchan and social media campaign, was also launched at the event. The Minister also launched the 'Third line ART programme for People Living with HIV'. The life-saving third line ART costs nearly Rs 1.18 lakh per patient per year. Providing these free would not only safe lives but improve socioeconomic conditions of the patients. This initiative brings India's ART programme at par with programmes in the developed countries. Shri B P Sharma, Secretary (HFW) highlighted the need for collective commitment of all stakeholders. He stated that the Revised National Tuberculosis Control Program (RNTCP) is one of the most successful programmes. "The programme has made significant impact on prevalence and treatment of TB", said Shri B P Sharma. He further added that 300 CBNAAT machines have already been installed and 200 more will be installed soon. "Quality of treatment has to be even over the public and private sectors. It has to be well supported by a strong procurement so that it can be sustained till 2030, said Shri B P Sharma. Secretary (Health) also laid emphasis on surveillance and monitoring. He said that we need new tools for diagnostics and new research. He further said that delivery mechanism should be in conformity with goals we have set for ourselves. Speaking on the occasion, Dr Saumya Swaminathan, Secretary (DHR) and DG (ICMR), highlighted the challenges of the frontline health workers. She said that there is a need for new and innovative tools for conducting tests and investment in research. She further added that we need to use drugs optimally. Also present on this occasion were, Dr (Prof) Jagdish Prasad, DGHS, Shri C K Mishra, AS & MD, and other senior officers of the Health Ministry, representatives of WHO, World Bank and other development partners. ]]> <![CDATA[Gastric cancer drug development shifting from small molecules to mABs]]> https://biospectrumindia.com/features/95/7846/gastric-cancer-drug-development-shifting-from-small-molecules-to-mabs.html https://biospectrumindia.com/features/95/7846/gastric-cancer-drug-development-shifting-from-small-molecules-to-mabs.html Mon, 21 Mar 2016 14:20:49 +0530 While 99% of currently marketed gastric cancer drugs are small molecules, this dominance could give way to more innovative treatments in future, as the pipeline consists of 29% monoclonal antibodies (mAbs), according to business intelligence provider GBI Research. The company's latest report states that there are currently 241 products in the gastric cancer pipeline, a number of which have different mechanisms of action and targets to the dominant marketed therapies. Mr Firas Nour, Associate Analyst for GBI Research, says that while Herceptin and Cyramza are the only mAbs currently on the market for gastric cancer, mAbs have shown strong clinical results and advantageous properties in numerous oncology indications, meaning they account for a relatively large proportion of many oncology pipelines. He says: "Data suggest that some biologics, such as mAbs, have more favorable risk profiles and, due to their higher target specificity, frequently perform more strongly in terms of both safety and efficacy than their synthetic counterparts. Moreover, the higher technological barrier for competitors to develop biosimilars can provide a further incentive. "However, while the diversification of therapeutic molecule types for marketed and pipeline products has opened new clinical and commercial opportunities, this in itself is not a guarantee of future success, and investment in product development as well as manufacturing facilities is significantly higher." GBI Research also states that the innovative gastric cancer pipeline will allow the treatment space to become more diverse and less reliant on highly cytotoxic chemotherapy regimens, providing hope for sufferers who currently face very low survival rates. Mr Nour explains: "24% of gastric cancer products in active development are considered to be first-in-class, suggesting that the industry is pursuing novel approaches to treatment, and reducing the focus on established therapies. "First-in-class development can be highly lucrative if clinically successful, but is also associated with high risks, as clinical efficacy is certainly not guaranteed. Therefore, it must be considered that although having a high proportion of first-in-class products is a promising indicator in a pipeline, there is substantial variation in these products regarding their clinical promise and potential market impact." ]]> <![CDATA[Torrent Pharma's Dahej Plant receives EIR from FDA]]> https://biospectrumindia.com/news/95/7825/torrent-pharmas-dahej-plant-receives-eir-from-fda.html https://biospectrumindia.com/news/95/7825/torrent-pharmas-dahej-plant-receives-eir-from-fda.html Mon, 21 Mar 2016 12:50:41 +0530 Prior to this approval, the Plant has also received approval from EU Germany. It was set up to cater mainly to the regulated international markets such as US, Brazil, Germany etc. With the approval, this plant is now the 3rd plant of Torrent Pharma to receive US FDA approval, out of its 5 manufacturing units. The company's other US FDA approved plant include the Plant at Indrad, Gujarat and Pithampur (Indore), MP. The plant is spread across 70 acres with a built up area of around 97000 sq. mtr. Phase I has an installed capacity of about 7,500 million tablets / capsules and 25 MT API per annum. As per the company, Construction of Phase II will commence soon and once commissioned the total capacity will increase to about 14,000 million tablets / capsules and 80 MT API per year. ]]> <![CDATA[Aurobindo Pharma receives FDA approval for Naproxen Sodium Tablets]]> https://biospectrumindia.com/news/95/8363/aurobindo-pharma-receives-fda-approval-for-naproxen-sodium-tablets.html https://biospectrumindia.com/news/95/8363/aurobindo-pharma-receives-fda-approval-for-naproxen-sodium-tablets.html Mon, 21 Mar 2016 12:50:14 +0530 Aurobindo Pharma is pleased to announce that the company has received final approval from the US Food and Drug Administration (USFDA) to manufacture and market Naproxen Sodium Tablets USP, 220 mg (OTC). This product is expected to be launched in Q1 FY16-17. The approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) Aleve Tablets, of Bayer Healthcare. Naproxen Sodium Tablets is used in the treatment and prevention of osteoporosis in postmenopausal women. The approved product has an estimated market size of $96 million for the twelve months ending January 2016 according to IMS. ]]> <![CDATA[Pfizer announces new managing director]]> https://biospectrumindia.com/news/95/8186/pfizer-announces-new-managing-director.html https://biospectrumindia.com/news/95/8186/pfizer-announces-new-managing-director.html Fri, 18 Mar 2016 15:22:00 +0530 "Pfizer has announced that the Board of Directors of the Company has appointed Mr S Sridhar as the Managing Director of the Company, with effect from March 18, 2016 for a period of 5 years," the company said in a filing to BSE. "The appointment of Mr S Sridhar will be subject to the approval of shareholders at the ensuing Annual General Meeting of the company," it added. Mr Sridhar joined Pfizer in June 2008. He assumed additional responsibility of the Distribution function from May 2013. Before joining Pfizer, Mr Sridhar was the Finance Director in India Hub of Diageo India. Mr Sridhar was appointed to the Board on May 14, 2013. ]]> <![CDATA[Significant opportunities remain for new entrants to invigorate stagnant bipolar market]]> https://biospectrumindia.com/features/95/3045/significant-opportunities-remain-for-new-entrants-to-invigorate-stagnant-bipolar-market.html https://biospectrumindia.com/features/95/3045/significant-opportunities-remain-for-new-entrants-to-invigorate-stagnant-bipolar-market.html Fri, 18 Mar 2016 12:56:46 +0530 Lucrative opportunities remain for new entrants in the currently declining bipolar disorder market, as there is a considerable dearth of products that fully address the needs of sufferers, according to research and consulting firm GlobalData. The company's report states that the current bipolar pipeline is sparse, with only two drugs, Abilify Maintena and ITI-007, expected to receive regulatory approval by 2024. GlobalData forecasts that Abilify Maintena will achieve sales of $643 million in 2024 across the eight major markets of the US, France, Germany, Italy, Spain, UK, Japan and Canada. However, bipolar disorder has a range of unmet needs, including the need for novel, effective treatment options for bipolar depression, drugs with improved safety profiles, improved physician education about the diagnostic process, and for drugs developed specifically for bipolar disorder, as opposed to manufacturers targeting approval simultaneously with other indications. Mr Thomas Parker, GlobalData's Senior Analyst covering Neurology and Ophthalmology, says targeting the treatment of major depressive episodes will represent a significant ongoing opportunity, owing to the paucity of currently available treatments. He explains: "A novel product that demonstrates efficacy in terms of reducing depressive symptoms versus placebo would likely be viewed favorably by physicians, providing its safety profile is comparable to the newer atypical antipsychotics. "An important opportunity also exists for the development of a novel mood stabilizer with an improved safety profile that is indicated for the long-term maintenance treatment of bipolar disorder. Current mood stabilizers are associated with a variety of adverse events that can significantly impact treatment outcomes." GlobalData believes that future mood stabilizers will need to demonstrate placebo-like tolerability while also possessing low teratogenicity, limited drug interactions, and an efficacy that is comparable to lithium. Mr Parker concludes: "It is generally believed that the paucity of novel agents in development is influenced by the absence of preclinical animal models for bipolar disorder. In this way, a major imperative for developers could be to cultivate a novel preclinical animal model of bipolar disorder in order to identify novel products with high efficacy." ]]> <![CDATA[Entries open for 'Social Entrepreneur of the Year (SEOY)-India Award 2016']]> https://biospectrumindia.com/news/95/8487/entries-open-for-social-entrepreneur-of-the-year-seoy-india-award-2016.html https://biospectrumindia.com/news/95/8487/entries-open-for-social-entrepreneur-of-the-year-seoy-india-award-2016.html Fri, 18 Mar 2016 12:55:33 +0530 The Schwab Foundation for Social Entrepreneurship, a sister organization of the World Economic Forum, in partnership with the Jubilant Bhartia Foundation announces opening of entries for the annual competition -Social Entrepreneur of the Year (SEOY) India Award 2016. SEOY India searches for leading social entrepreneurs from the country. The applications will be accepted till April 30, 2016. The applicants are evaluated on key parameters of innovation, sustainability, reach and social impact. Finalists will be selected following an intensive search and selection process, including expert reviews and site visits. The winner is selected by a prominent Jury consisting of eminent professionals from different walks of life. The award will be presented at a high-profile event in New Delhi. The winners of 'Social Entrepreneur of the Year (SEOY) India Award 2016' will participate in the annual and regional meetings of the World Economic Forum, which provides unprecedented opportunities to engage with global decision makers from the public, corporate, media, academic, and civil society sectors. The Social Entrepreneur of the Year (SEOY) India Award, organized annually by Schwab Foundation for Social Entrepreneurship and Jubilant Bhartia Foundation, attracts hundreds of social entrepreneurs from all over the country. The award celebrates leading social entrepreneurs and their ventures that implement innovative, practical and sustainable solutions to address poverty and the lack of basic services and resources in 'Bottom of the Pyramid' and ultra-poor communities (i.e. health, education, job creation, water, clean energy and access to information and technology). Whether they are set up as for-profit entities, hybrid social ventures or not-for-profit organizations, their primary focus is transformational social change. Social entrepreneurs develop a revenue stream through the sale of products, services, fees or develop key partnerships to achieve sustainability. The award promotes social entrepreneurs in India by recognizing organizations that work to promote inclusive growth and contribute to bring change to society through their entrepreneurial vision. 2016 celebrates seventh year of partnership between Schwab Foundation for Social Entrepreneurship and Jubilant Bhartia Foundation. Last year, Ms Poonam Bir Kasturi of Daily Dump (Bengaluru) was awarded as the Social Entrepreneur of the Year India Award 2015 by Shri Piyush Goyal, Minister of State (Independent Charge) for Power, Coal, New & Renewable Energy Government of India. ]]> <![CDATA[Glenmark receives tentative approval for new generic ]]> https://biospectrumindia.com/news/95/8311/glenmark-receives-tentative-approval-for-new-generic-.html https://biospectrumindia.com/news/95/8311/glenmark-receives-tentative-approval-for-new-generic-.html Fri, 18 Mar 2016 11:45:12 +0530 Glenmark Pharmaceuticals USA (Glenmark) has been granted tentative approval by the United States Food and Drug Administration (US FDA) its Lacosamide Oral Solution, 10 mg/mL, the generic version of Vimpat Oral Solution, 10 mg/mL of UCB, Inc. Glenmark will market this product upon receiving final approval of its Lacosamide Oral Solution, 10 mg/mL ANDA. The patent listed in the Orange Book for Vimpat Oral Solution, 10 mg/mL is scheduled to expire on March 17, 2022. According to IMS Health sales data for the 12 month period ending January 2016, the Vimpat market achieved annual sales of approximately $55.4 million. ]]> <![CDATA[Novartis launches Scapho the first IL-17A inhibitor to receive approval in India ]]> https://biospectrumindia.com/news/95/8465/novartis-launches-scapho-the-first-il-17a-inhibitor-to-receive-approval-in-india-.html https://biospectrumindia.com/news/95/8465/novartis-launches-scapho-the-first-il-17a-inhibitor-to-receive-approval-in-india-.html Thu, 17 Mar 2016 16:31:11 +0530 Novartis Healthcare Private Limited announced the launch of Scapho (secukinumab)150 mg, for the treatment of moderate-to-severe plaque psoriasis in adult patients. Scapho is an injectable medicine and the first interleukin-17A (IL-17A) inhibitor to be approved in India2.This approval marks a significant milestone in the treatment of psoriasis, providing a new and important first-line biologic treatment option for patients who are candidates for systemic therapy. Secukinumab was developed for the treatment of moderate to severe plaque psoriasis in adult patients who are candidates for systemic therapy with a recommended dose of 300 mg. Secukinumab has demonstrated a statistically significant improvement in clearing psoriatic lesions as early as 3 weeks. "This is groundbreaking news as clear skin can now be a reality for patients struggling to cope with psoriasis," said Dr. Anchala Parthasaradhi, Director - Anchala Skin Institute - Hyderabad. "Most psoriasis patients are not content with current therapy options including the earlier biologics and there is a significant unmet need. Secukinumab seems to be a promising treatment for psoriasis and can provide patients a better chance of achieving clear or almost clear skin. Importantly this therapy comes as an alternative to treatments that have significant side effects." "At Novartis, our mission to discover new ways to improve and extend people's lives underscores our values and we are very happy to launch Scapho® in India for the treatment of moderate to severe psoriasis," said Jawed Zia, Country President, Novartis India. "This signifies an important turning point in the treatment of psoriasis in India. Patients in India, can now benefit from this treatment as it has the proven ability to offer clear or almost clear skin." The key treatment goal for psoriasis patients is achieving clear skin. In clinical studies, 70% or more patients on secukinumab 300 mg achieved clear skin (PASI 100) or almost clear skin (PASI 90), during the first 16 weeks of treatment and importantly, this was maintained with continued treatment in the majority of patients up to Week 52. Data from the Scapho clinical trial program also showed a significant positive relationship between achieving clear to almost clear skin and psoriasis patients' health-related quality of life. ]]> <![CDATA[Hot Start-ups: Geared to redefine global farming scene]]> https://biospectrumindia.com/features/95/8350/hot-start-ups-geared-to-redefine-global-farming-scene.html https://biospectrumindia.com/features/95/8350/hot-start-ups-geared-to-redefine-global-farming-scene.html Thu, 17 Mar 2016 13:02:04 +0530 For entrepreneurs Dr Kavitha Sairam (36) and Mr Anant Raheja (28), the entrepreneurial journey was more incidental than a planned one. The duo founded FIB-SOL Life Technologies in 2013 at IIT-Madras business incubator while pursuing their PhDs. "We aim to make farming profitable," says Dr Kavitha. "The current state of farming in the country has left individual and corporate farms high and dry, demanding better inputs." Dr Kavitha has a PhD in fungal stress biology, which helped her develop stabilizing formulations for FIB-SOL's agro-inputs. At the moment, Mr Anant is awaiting his PhD, and has a rich research experience in developing polymeric nanomaterials, which forms the basis of platform technology developed at FIB-SOL. Prior to FIB-SOL, when the Biotech department at IIT-M announced their entrepreneurship support scheme, Dr Kavitha was already looking for career opportunities, and Mr Anant had an inconclusive experiment in tow. The Biotech department announced a Biotech Entrepreneurship support scheme with a financial support of Rs 10 lakh for an innovative idea, which could be later translated into a product. "We as a team pitched in the idea of applying nanotechnology for developing highly effective fertilizers with a reduced bulk of 1000x. The path was inspired by previous success of Sea6 Energy, which also is an IIT-M start-up," Dr Kavitha recalls. Plan Of Action The first plan of action for FIB-SOL's team was to develop its ideas into an innovative product which would be of real value to its customers. Dr Kavitha reveals, "In our case, undoubtedly, our clients were the farmers. Therefore, we immediately made an effort to understand our customers. We started visiting local farms, and farms of anyone whom we knew. This gave us a lot of insight into the workings of agro-business." Following which they built an efficient team with like-mindedness to take the idea forward. This was well supported by the constant interest shown by the interns from IIT-M, and as well as from other universities. In due course, FIB-SOL's inputs fetched in grants which helped the start-up to hire long-term employees. FIB-SOL is now closely working with corporate plantations, learning more about their needs, and helping in improving product design. "We would like to work more with small and medium scale farmers, and help them to improve their productivity with our technology," Dr Kavitha expresses. The agriculture sector, says Dr Kavitha, across the globe has seen numerous innovations, in the form of machinery, chemical inputs and biological entities. "However, these innovations have not percolated the traditional farming sector in developing and under-developed economies. The increasing awareness on organic and traditional farming practices is a very promising scenario, and hopefully the innovations would reach the farming community," she feels. Finding A Foothold FIB-SOL's major strength is in its R&D. "We have developed our first line of membrane products for efficient delivery of agro-inputs. In addition, we offer microbial analytical services to the Biotech industry functioning in the field of agriculture and waste water treatment," adds Dr Kavitha. As seasoned researchers, the founders' initial challenges was in understanding the ways of an independent start-up. "We had to shelve a lot of our ideas to focus on a few, rather than get distracted. Further, it was difficult to manage with limited resources," she comments. In fact, Mr Anant had to take up a consultancy job to manage his finances to prevent burning out of investments. However, the start-up began to stabilize upon receiving more funds in 2015. So far the start-up has been funded through angels and Government grants. It has not applied for VC funds or full investments. But we'll look in that direction during scale-up, says Dr Kavitha. Through various grants and seed funds, FIB-SOL has invested Rs 48 lakh in the company. "We have been able to bag 3 seed grants close to Rs 30 lakh in the last year alone," she reveals. Product Diversification The start-up states that instead of trying to explain to VCs about the functioning of a Life Sciences start-up, it looks for investors or shareholders who are experienced in the field, and are able to understand the technology before investing in it. We look for technology partners rather than just an investor, Dr Kavitha notes. The start-up plans to diversify its product range, and fortify the existing products with more functionality. Dr Kavitha explains, "We wish to take our technology to countries which rely on agriculture as their major income source, such as our neighboring countries, African nations and South Americas. Of course, the product would be equally useful for Western nations including US and Europe, which have large acreage of farms." The company looks forward to start-up impetus from private corporations and their role in supporting new ideas by taking up the role of clients, investors and partners. Start-up Hub She says that India and the West are very different in their approaches, but similar in their spirit about start-ups. "India sees start-up community as a means to solve its societal issues. On the other hand, start-ups are more individualistic and a means of making windfall gains, in the West. Both the concepts are equally good in their respective geographies, and should not be compared on the same level," she opines. To this, she also adds that Indian metro cities like Mumbai, Chennai and Delhi have very well caught up with Bangalore and Hyderabad's start-up scene. "Although, these cities lack the luxurious spaces enjoyed at Bangalore and Hyderabad, they do have a very experienced community of entrepreneurs, who have converted small start-ups of yesterday in to huge corporations of today," she highlights. Start-up Lessons Ask her what qualities make a successful entrepreneur? "The only essential quality needed in any career is an individual's perseverance followed by a strong character," Dr Kavitha voices. Entrepreneurial journey can teach invaluable lessons. Mr Anant, an avid reader, traveler and videogames player, says that he has learnt to be versatile in planning activities, taking into account numerous uncertainties of a start-up day. "This journey has taught me not to underestimate the talent of a person, irrespective of their technical backgrounds. Anyone can have a good idea, but it requires perseverance and patience to execute it, which in turn requires a team effort," he stresses, In her words, Dr Kavitha says the start-up journey has taught her to handle any tough situation in a more relaxed and natural way. "I have learnt to respect every individual's capabilities, and to look forward for opportunities in every unusual circumstances. Though we all accept that hard work is the key to success, I have started believing strongly that smart work does not need keys, it just finds the open doors," concludes Dr Kavitha, who is also a classical dancer. Entrepreneurial Mistakes To Avoid: ï‚§ Lack of long-term visionï‚§ Lack of understanding investment partners on boardï‚§ Lack of simplicity in product design Life Sciences Start-up Myths To Bust: ï‚§ Rapid revenue generation impossibleï‚§ Complicated productsï‚§ Only deal with drugs and pharmaceuticals ]]> <![CDATA[Biocon inks co-development & commercialization agreement with Lab PiSA for rh- Insulin in USA ]]> https://biospectrumindia.com/news/95/8264/biocon-inks-co-development-commercialization-agreement-with-lab-pisa-for-rh-insulin-in-usa-.html https://biospectrumindia.com/news/95/8264/biocon-inks-co-development-commercialization-agreement-with-lab-pisa-for-rh-insulin-in-usa-.html Thu, 17 Mar 2016 12:24:04 +0530 Biocon Ltd. announced that its wholly owned subsidiary Biocon SA has entered into an agreement with Laboratorios PiSA S.A. de C.V (PiSA) of Mexico for the co-development and commercialization of generic recombinant human insulin (rh-insulin) for the US market. This collaboration is a part of Biocon's strategy to address the large demand for generic rh-insulin in the US, which accounts for over 40% of the global sales of $5 billion. This is an extension of the company's long standing relationship of over 10 years with its trusted partner, PiSA, who has a dominant position in insulins in Mexico. Biocon's Insulin Glargine was the first to be approved in Mexico in 2015, as per the new bio-comparable approvals pathway. Both companies are committed to providing affordable access to insulins to patients. This is a cost and profit sharing agreement with Biocon responsible for clinical development, regulatory approvals, and commercialization of the product in the US. This partnership will leverage Biocon's manufacturing facilities for the drug substance and PiSA's drug product facilities in Mexico. Furthermore, this arrangement will take advantage of Pisa's proximity to the US market and Mexico's NAFTA membership, which will ensure an efficient and optimal supply chain to address the needs of the US healthcare system for an affordable, high quality rh-insulin. Biocon's global clinical development experience with Insulin Glargine for the US will be a useful precedent in developing rh-insulin for the US market. Through this collaboration, we will introduce rh- insulin under the Biocon brand to address the US $2 bn market opportunity in the US. Biocon Chairperson & Managing Director Kiran Mazumdar-Shaw said: "Our partnership with PiSA demonstrates our commitment to provide access to affordable insulins to patients in the US. This collaboration will enable us to manufacture the rh-insulin drug product at PiSA's facilities in Mexico and commercialize it under Brand Biocon in the US market, which has a huge diabetes burden with over 1.4 million* people diagnosed with diabetes every year." PiSA Chairman & President Carlos Alvarez Bermejillo stated "Applying PiSA's world class, state of the art sterile injectable and biotechnology development & manufacturing capabilities to contract manufacture Biocon's generic rh- insulin products represents a major milestone in PiSA's strategy to enter the US sterile injectable market"."PiSA has been marketing insulin products based on Biocon's high quality API for many years, hence this partnership to develop generic rh- insulin products represents the natural progression of a strong relationship between the two firms", he added. Biocon is recognized as Asia's largest insulins producer and has been committed to provide affordable diabetes management through rh-Insulin (Insugen) and Insulin Glargine (Basalog) in India and several emerging markets. The company currently has marketing approvals in over 60 countries for rh-Insulin and in over 20 countries for Insulin Glargine. ]]> <![CDATA[Cipla invests extra $3 mn in Chase Pharmaceuticals]]> https://biospectrumindia.com/news/95/8299/cipla-invests-extra-3-mn-in-chase-pharmaceuticals.html https://biospectrumindia.com/news/95/8299/cipla-invests-extra-3-mn-in-chase-pharmaceuticals.html Thu, 17 Mar 2016 11:33:53 +0530 "Cipla (EU) Limited, UK ("Cipla UK"), a wholly owned subsidiary of the Company, has pursuant to the approval of the board of Cipla UK, made an additional investment of $3 million in Chase Pharmaceuticals Corporation US ("Chase") towards full settlement of its obligation under the agreed arrangement for investment in Chase," Cipla said in a filing to BSE "Consequently, Cipla UK's total investment in Chase would aggregate to approximately $5.12 million for a 16.7 percent stake on a fully diluted basis," it added. The company in May 2014 had invested $1.5 million to acquire 14.6 percent stake in Chase Pharmaceuticals. ]]> <![CDATA[Did Indian Govt assure US to discontinue compulsory licensing?]]> https://biospectrumindia.com/news/95/8173/did-indian-govt-assure-us-to-discontinue-compulsory-licensing.html https://biospectrumindia.com/news/95/8173/did-indian-govt-assure-us-to-discontinue-compulsory-licensing.html Wed, 16 Mar 2016 15:17:01 +0530 MÃ©decins Sans FrontiÃ¨res (MSF) is deeply concerned about the recent revelations in the media that a US industry lobby group - the US India Business Council (USIBC) and US Chamber of Commerce - has received verbal, private assurances from Indian officials that it will not use 'compulsory licensing' (CL) for commercial purposes. The statements are part of USIBC's submission to USTR's (US Trade Representative) annual Special 301 report. Many US industries, in particular the pharmaceutical industry, use the report to condemn governments which employ intellectual property (IP) systems that do not match intellectual property laws and practices in the United States. Current US intellectual property laws enable drug makers to charge exorbitant prices for medicines, such as Gilead Sciences, which charge up to US$1,000 a pill for new hepatitis C drug sofosbuvir. India-the world's principal producer and supplier of quality generic medicines, including for US-funded treatment programs like PEPFAR that support antiretroviral treatment in developing countries- has in recent years repeatedly been singled out by the US government and the multinational pharmaceutical industry for insufficient enforcement of intellectual property. "For almost a decade, India has championed affordable access to medicines by setting strict patentability standards and issuing compulsory licenses, both of which are legal tools available to all governments under the TRIPS Agreement. These legal tools have never been as crucial as they are today, as the Indian patent office considers patent applications on new life-saving medicines to treat infectious diseases - such as sofosbuvir or dolutegravir for HIV and hepatitis C - and on critical vaccines like the pneumococcal conjugate vaccine (PCV)," said MSF. Compulsory licenses can be granted on many grounds including but not limited to: non-working of a patent, addressing anti-competitive conduct, reducing prices of unaffordable medicines and addressing public health emergencies. Yet, the USIBC and other pharma lobbies are working to discourage the Indian government, its patent authorities and courts from using these legal tools available under both Indian patent law and international trade rules. "Any commitment to stop granting compulsory licenses and enforce patent law safeguards will defeat the legislative intent of the public health safeguards that are enshrined in India's patent law, and which were globally welcomed by the United Nations, MSF and developing country governments in 2005. Such a commitment will encourage multinational drug companies to start charging unaffordable prices to Indian patients and governments across the developing world, further undermining access to critical, and life-saving products," added Ms Leena Menghaney, Regional Head-South Asia, MSF Access Campaign. In June 2015 MSF launched a campaign using #HandsOffOurMeds, to urge Indian Prime Minister Narendra Modi to stand strong in the face of intensifying pressure from the United States, Japan, Switzerland and the European Union to change India's laws and policies in ways that would severely restrict the country's ability to produce affordable medicines, upon which millions of people around the world rely. ]]> <![CDATA[Glioblastoma treatment hopes turn to combining peptide vaccines with Immuno-Oncology products]]> https://biospectrumindia.com/features/95/8158/glioblastoma-treatment-hopes-turn-to-combining-peptide-vaccines-with-immuno-oncology-products.html https://biospectrumindia.com/features/95/8158/glioblastoma-treatment-hopes-turn-to-combining-peptide-vaccines-with-immuno-oncology-products.html Wed, 16 Mar 2016 15:14:50 +0530 The termination of Celldex's Phase III trial assessing its peptide-based vaccine therapy, Rintega, in newly-diagnosed glioblastoma patients, represents a blow to the treatment space as hopes for improved therapies turn instead to Opdivo and drugs combining peptide vaccines with immuno-oncology products, according to analysts with research and consulting firm GlobalData. In a press release on March 7, 2016, Celldex stated that the trial was terminated because "Rintega has performed consistently with prior Phase II studies but the control arm has significantly outperformed expectations." Dr Dan Roberts, GlobalData's Senior Analyst covering Oncology and Hematology, explains: "The fact that this study involved a control arm which outperformed historical controls was not unexpected, as patients who were enrolled in this trial underwent total resection and had no evidence of a progressive disease." Indeed, as stated in GlobalData's glioblastoma report from December 2015, "comparison to historical values must be interpreted with caution, as these patients typically have higher survival than the general glioblastoma population." Dr Maxime Bourgognon, GlobalData's Analyst covering Oncology and Hematology, says that despite Rintega's disappointments, there are reasons for glioblastoma patients to be optimistic, as immunotherapy agents hold great promise for those faced with high unmet needs and extremely poor survival. Dr Bourgognon explains: "There are several late-stage vaccines being evaluated for glioblastoma patients, with ImmunoCellular Therapeutics' ICT-107 holding the highest probability of success. "It is also anticipated that the upcoming launch of Bristol-Myers Squibb's PD-1 inhibitor, Opdivo, in both the newly-diagnosed and recurrent settings, will change glioblastoma's treatment algorithm by improving patient survival." GlobalData believes that while peptide vaccines are currently underdeveloped, they hold promise going forward, particularly if they are made up of potential synergistic combinations with active immuno-oncology products which specifically target the immune system, such as checkpoint inhibitors. Dr Roberts concludes: "Combining peptide vaccines with active immuno-oncology products is scientifically and commercially promising, as these combinations will be able to differentiate themselves in an increasingly crowded glioblastoma market." ]]> <![CDATA[MSF launches challenge to Pfizer's patent on pneumonia vaccine in India]]> https://biospectrumindia.com/news/95/8072/msf-launches-challenge-to-pfizers-patent-on-pneumonia-vaccine-in-india.html https://biospectrumindia.com/news/95/8072/msf-launches-challenge-to-pfizers-patent-on-pneumonia-vaccine-in-india.html Tue, 15 Mar 2016 14:54:23 +0530 MÃ©decins Sans FrontiÃ¨res/Doctors Without Borders (MSF) has filed a 'patent opposition' in India to prevent US pharmaceutical company Pfizer from getting a patent on the pneumococcal conjugate vaccine (PCV13), so more affordable versions can become available to developing countries and humanitarian organizations. This is the first time a vaccine (biosimilar) patent has been challenged in India by a medical organization, with the goal of millions more children being protected against deadly pneumonia. Pneumonia is the leading cause of childhood death, killing almost one million children each year. Currently, pharmaceutical companies Pfizer and GlaxoSmithKline (GSK) are the only two manufacturers of the vaccine, which could prevent a large number of these deaths. Pfizer has priced PCV13 (marketed as Prevenar) out of reach of many developing countries and humanitarian organizations. It is now 68 times more expensive to vaccinate a child than in 2001, according to a 2015 MSF report, The Right Shot: Bringing down Barriers to Affordable and Adapted Vaccines. "The pneumonia vaccine is the world's best-selling vaccine, and last year alone, Pfizer brought in more than US$6 billion dollars in sales just for this product-meanwhile many developing countries, where millions of children risk getting pneumonia, simply can't afford it," said Dr Manica Balasegaram, Executive Director, MSF's Access Campaign. "To make sure children everywhere can be protected from deadly pneumonia, other companies need to enter the market to supply this vaccine for a much lower price than what Pfizer charges." One vaccine producer in India has already announced that it could supply the pneumonia vaccine for $6 dollars per child (for all three doses) to public health programmes and humanitarian organisations like MSF. This is almost half the current lowest global price of $10 dollars per child, which is only available to a limited number of developing countries via donor funding through Gavi, the Vaccine Alliance. In 2015, all 193 countries at the World Health Assembly passed a landmark resolution demanding more affordable vaccines and increased transparency around vaccine prices. "Last year, more than 50 countries spoke out against high vaccine prices and about the difficulties of introducing new vaccines, including Indonesia, Jordan and Tunisia. We can't wait any longer for all countries to be able to afford this vaccine," said Dr Balasegaram. The pre-grant opposition-a form of citizen review at the patent examination stage-submits technical grounds before the patent office to show that claims that cover a certain aspect of a drug or vaccine do not merit patenting under India's Patents Act. An equivalent patent to the one opposed today in India was already revoked by the European Patent Office (EPO) and is currently being challenged in South Korea. Pfizer's patent application involves the methods of conjugating 13 serotypes of streptococcus pneumonia into a single carrier. "Our pre-grant opposition shows that the method Pfizer is trying to patent is too obvious to deserve a patent under Indian law, and is just a way to guarantee a market monopoly for Pfizer for many years to come," said Ms Leena Menghaney, Head of MSF's Access Campaign in South Asia. "India must rebuff demands from pharmaceutical companies, which are backed by diplomatic pressure tactics of the US and other governments, that India change its patentability standards to restrict generic competition. Pfizer's unmerited patent application on the pneumonia vaccine should be rejected, opening the door to more affordable versions of the vaccines being produced." After years of fruitless negotiations with Pfizer to lower the vaccine's price for use in its projects, MSF is challenging this patent application in India to ensure that manufacturers who are planning to produce the pneumonia vaccine do not face key patent barriers at the time of launching a more affordable version. "Pneumonia kills a child every 35 seconds," said Dr Balasegaram. "As doctors who have watched far too many children die of pneumonia, we're not going to back down until we know that all countries can afford this vaccine." ]]> <![CDATA[The theme for World Health Day 2016 is diabetes]]> https://biospectrumindia.com/news/95/8352/the-theme-for-world-health-day-2016-is-diabetes.html https://biospectrumindia.com/news/95/8352/the-theme-for-world-health-day-2016-is-diabetes.html Tue, 15 Mar 2016 10:38:28 +0530 Each year a theme is selected that highlights a priority area of public health. The day provides an opportunity for individuals in every community to get involved in activities that can lead to better health. As per WHO, In 2008, an estimated 347 million people in the world had diabetes and the prevalence is growing, particularly in low- and middle-income countries. India had 69.2 million people living with diabetes (8.7 percent) as per the 2015 data. Of these, it remained undiagnosed in more than 36 million people. Goal of World Health Day 2016: Scale up prevention, strengthen care, and enhance surveillance of diabetes The main goals of the World Health Day 2016 campaign aims to:Increase awareness about the rise in diabetes, and its staggering burden and consequences, in particular in low-and middle-income countries; Trigger a set of specific, effective and affordable actions to tackle diabetes. These will include steps to prevent diabetes and diagnose, treat and care for people with diabetes; and Launch the first Global report on diabetes, which will describe the burden and consequences of diabetes and advocate for stronger health systems to ensure improved surveillance, enhanced prevention, and more effective management of diabetes. There are two main forms of the diabetes. People with type 1 diabetes typically make none of their own insulin and therefore require insulin injections to survive. People with type 2 diabetes, the form that comprises some 90 percent of cases, usually produce their own insulin, but not enough or they are unable to use it properly. People with type 2 diabetes are typically overweight and sedentary, two conditions that raise a person's insulin needs. It may also be seen during pregnancy. World Health Day 2016: Key messagesThe diabetes epidemic is rapidly increasing in many countries, with the documented increase most dramatic in low- and middle-income countries. A large proportion of diabetes cases are preventable. Simple lifestyle measures have been shown to be effective in preventing or delaying the onset of type 2 diabetes. Maintaining normal body weight, engaging in regular physical activity, and eating a healthy diet can reduce the risk of diabetes. Diabetes is treatable. Diabetes can be controlled and managed to prevent complications. Increasing access to diagnosis, self-management education and affordable treatment are vital components of the response. Efforts to prevent and treat diabetes will be important to achieve the global Sustainable Development Goal 3 target of reducing premature mortality from noncommunicable diseases (NCDs) by one-third by 2030. Many sectors of society have a role to play, including governments, employers, educators, manufacturers, civil society, private sector, the media and individuals themselves. ]]> <![CDATA[Vaccination â€“ Benefits beyond health]]> https://biospectrumindia.com/news/95/8025/vaccination-benefits-beyond-health.html https://biospectrumindia.com/news/95/8025/vaccination-benefits-beyond-health.html Mon, 14 Mar 2016 16:09:30 +0530 With the exception of clean water, no other modality, not even antibiotics, has had such a major effect on mortality reduction. The value of vaccination extends beyond providing just positive health outcomes; it supports socio-economic development through saving lives and saving money. "Immunization is one of the most cost-effective public-health investments to decrease poverty and prevent longer term economic and social costs," said Dr Shafi Kolhapure, GM, Clinical R&D and Medical Affairs (Vaccines), South Asia, GSK Pharmaceuticals India. The way we view vaccines and vaccines development requires a rethink, built on an appreciation of the value of prevention which in nearly all cases confers positive health economic benefits to society. Childhood Vaccination By helping to keep children healthy, immunization can extend life expectancy and the time spent on productive activity - thereby contributing to poverty reduction. Beyond preventing more than 426 million cases of illness and averting 6.4 million deaths over the next ten years, immunizing children would hold major economic benefits for both families and governments. Expanding childhood immunization rates in the world's 72 poorest countries over the next decade would result in an estimated US $151 billion in treatment and productivity savings. The ability to avert 6.4 million deaths by improving vaccine coverage has an estimated value of US $231 billion for those in at-risk countries Adult and Adolescent Vaccination Dr Kolhapure added, "Amidst the current demographic trends, adult and adolescent vaccination offers a cost-effective solution to maintaining public health and helps the aging to be more active and productive." Seasonal influenza is a major economic burden. It can result in increased healthcare costs and workplace absences and reduced productivity. Studies from developed countries that suggest the total annual cost of influenza is between US $1 million to US $6 million per 100,000 population. Influenza vaccination may reduce the number of hospitalizations for pneumonia, influenza, bronchitis, or emphysema by 63%13 and reduce overall mortality by 75%. Human Papillomavirus (HPV), which causes cervical cancer - the third most common cancer in women, incidence rates vary from 1 to 50 per 100 000 females15. In Belgium, health economic data has shown that screening for and vaccinating against HPV would prevent an additional 646 cases of cervical cancer over the lifetime of a 100,000 female cohort compared with screening alone. ]]> <![CDATA[Essentra extends pharma packaging footprint in India]]> https://biospectrumindia.com/news/95/8023/essentra-extends-pharma-packaging-footprint-in-india.html https://biospectrumindia.com/news/95/8023/essentra-extends-pharma-packaging-footprint-in-india.html Mon, 14 Mar 2016 12:38:00 +0530 Essentra has a successful joint venture with ITC in Filter Products, which includes a further two manufacturing facilities and 150 employees. It has been present in India for 16 years, and employs 170 people in Bangalore, and through this acquisition will create an additional 120 local jobs. Headquartered in the UK and listed on the FTSE 250, Essentra has c. 9,000 employees across 33 countries. Mr P T Sreekumar, MD - Asia, Essentra, said: "With its highly complementary product range, Kamsri provides us with an entry point into the attractive pharmaceutical and healthcare industries in India, thereby reinforcing our global packaging capabilities and enhancing the opportunities for our customers. Our Health & Personal Care Packaging business now has a manufacturing presence in North America, Europe and India, and ships our extensive range of innovative products to 75 countries worldwide." The acquired cartons manufacturing assets which will incorporated into Essentra's existing site which opened in late 2013, and accommodates manufacturing, warehousing and commercial infrastructure over 70,000 sq. ft. Essentra India's GM Mr Narayan, said: "Continued growth in the local market, and its increasing status as a high quality, competitive manufacturing base, make India a key opportunity for the Essentra Group. The end-markets for our specialist components, such as healthcare and industrial products, are sizeable and well-established, with annual growth of up to 20%. Following the acquisition of Kamsri, our immediate focus will be adding their cartons capabilities to our existing tear tapes and securing solutions for packaging; however, we plan to further extend our specialist packaging range over the coming year." ]]> <![CDATA[Strong Life Sciences sector will drive UK pharmaceutical market to $43 bn by 2020]]> https://biospectrumindia.com/features/95/6970/strong-life-sciences-sector-will-drive-uk-pharmaceutical-market-to-43-bn-by-2020.html https://biospectrumindia.com/features/95/6970/strong-life-sciences-sector-will-drive-uk-pharmaceutical-market-to-43-bn-by-2020.html Fri, 11 Mar 2016 14:56:07 +0530 The pharmaceutical market in the UK is set to grow from $28.8 billion in 2015 to approximately $43 billion by 2020, representing a Compound Annual Growth Rate (CAGR) of 8.4%, driven primarily by a robust life sciences industry, according to research and consulting firm GlobalData. The company's latest report states that the UK's life sciences sector consists of just under 5,000 companies that develop, produce and market products and services in the pharmaceutical, medical device, and biotechnology markets. Mr Adam Dion, GlobalData's Senior Industry Analyst, says the pharmaceutical sector is one of the most dynamic industries in the UK and is a major contributor to the country's economy. He explains: "The pharmaceutical industry was the sixth largest contributor to the UK's balance of trade, contributing $46.9 billion (£32.4 billion) to the economy in 2014, according to the Association of the British Pharmaceutical Industry. "Research and development investment reached $5.9 billion (£4.2 billion) in 2013 in the UK, and the industry employed more than 68,000 staff, including 23,000 scientists and doctors." GlobalData's report also states that the UK's universal healthcare coverage and easy access to healthcare services, along with increasing rates of disease, have provided the necessary momentum for pharmaceutical market growth. Mr Dion continues: "The National Health Service (NHS) provides the UK with a robust healthcare system available to the entire population. This universal access to services means that the region incurs comparatively high healthcare costs, with expenditure in this area accounting for 8.6% of the GDP in 2012." ]]> <![CDATA[TAKE Solutions opens its first Pharmacovigilance peer network with pvindia]]> https://biospectrumindia.com/news/95/8255/take-solutions-opens-its-first-pharmacovigilance-peer-network-with-pvindia.html https://biospectrumindia.com/news/95/8255/take-solutions-opens-its-first-pharmacovigilance-peer-network-with-pvindia.html Fri, 11 Mar 2016 14:03:55 +0530 TAKE Solutions has announced the first meet of pvindia, a unique pharmacovigilance peer network, organized and managed by one of TAKE's Life Sciences division, Navitas. pvindia is a membership based network of emerging global pharma companies from India to meet and discuss some of the Industry's common challenges in Pharmacovigilance (Drug Safety). The inaugural meeting was attended by 25 Drug Safety professionals representing 14 Indian pharmaceutical and global pharmaceutical companies. The key discussion topics at the event were, Global harmonization of regulations, how companies adapt to a variety of international regulations and Inspection Readiness. Navitas plans to organize 2nd edition of pvindia in the month of October. Commenting on pvindia inaugural meeting, Mr Ram Yeleswarapu, president and CEO, TAKE Solutions said, "We are pleased to announce the introduction of our networks to India. The scale and convenience of collaboration facilitated by the network meets will explore and help generate new solutions to the challenges faced by players in the Indian Pharma landscape." He added, "The ambition for pvindia is to become an active think tank to improve safety practices across India, in order to ensure the ongoing protection of public health and increase awareness of the importance of Drug Safety amongst Healthcare Professionals and Patients." "I am glad to be a part of the inaugural meet of pvindia. At times when Indian companies like their colleagues in the US and EU are frequented by Inspectors of internal Health Authorities, there exists significant strain on any organization. Being prepared for any inspection is a priority for the Indian Pharmaceutical Industry in such scenarios" said Dr K Bangarurajan, deputy drugs controller of the CDSCO West. He further added, "pvindia will help companies to prepare for inspections triggered by these regulations." ]]> <![CDATA[Dr Reddy's, TR-Pharm announce collaboration in Turkey]]> https://biospectrumindia.com/news/95/6975/dr-reddys-tr-pharm-announce-collaboration-in-turkey.html https://biospectrumindia.com/news/95/6975/dr-reddys-tr-pharm-announce-collaboration-in-turkey.html Fri, 11 Mar 2016 14:03:34 +0530 Dr Reddy's Laboratories and TR-Pharm announced a strategic collaboration agreement involving 3 biosimilar products. A total of three products will be registered and subsequently commercialized as a part of this agreement by TR-Pharm in Turkey. TR-Pharm will also manufacture the drug substance and drug product upon completition of its facility investment. Mr Mehmet GÃ¶ker, general manager of TR-Pharm, said, "Biosimilars are a key component of our investment strategy in Turkey to establish biotechnological API production for national use and regional exports. This agreement will not only enable more affordable medication but also support our research and development initiatives by building expertise within the country. We are pleased to have already started laying out the groundwork for manufacturing with Dr. Reddy's for high quality biosimilar products." Mr M V Ramana, executive vice president and head branded markets (India and Emerging countries), said, "Turkey is a key emerging market and we are pleased to partner with TR-Pharm to ensure that patients in the region get access to our portfolio of high quality biosimilar products. Dr. Reddy's Laboratories is and remains committed to providing access to affordable and innovative drugs to populations around the world, and this partnership will make this happen in Turkey." TR-Pharm has begun laying out the groundwork for the technology transfer. This collaboration will be an important component of TR-Pharm's ongoing biological product development and manufacturing business in the region. The partnership will also enable Dr Reddy's to widen the global footprint of its biosimilar business. ]]> <![CDATA[Boehringer's Gilotrif to gain ground in NSCLC markets outside USA]]> https://biospectrumindia.com/news/95/8142/boehringers-gilotrif-to-gain-ground-in-nsclc-markets-outside-usa.html https://biospectrumindia.com/news/95/8142/boehringers-gilotrif-to-gain-ground-in-nsclc-markets-outside-usa.html Thu, 10 Mar 2016 16:01:21 +0530 The LUX-Lung 7 trial showed Gilotrif to reduce the risk of adenocarcinoma progression for patients with epidermal growth factor receptor (EGFR) mutations by 27% compared with one of its closest rivals, AstraZeneca's Iressa (gefitinib). The differential in progression-free survival at 18 months was 27% for Gilotrif and 15% for Iressa, increasing further at 24 months, to 18% and 8%, respectively. According to Dr Cai Xuan, GlobalData's analyst covering Oncology and Hematology, these recent trial results suggest that Gilotrif may have superior long-term efficacy to Iressa, which will encourage uptake in NSCLC markets in Europe and Asia. Dr Xuan explains: "In addition to Gilotrif's impressive progression-free survival data, more patients responded to Gilotrif treatment than Iressa, with response rates of 70% and 56%, respectively. "Despite this, it must be acknowledged that the frequency of serious adverse events was higher for Gilotrif than for Iressa, at rates of 44.4% and 37.1%, respectively. However, the treatment discontinuation rate for both drugs was 6.3%, as reported by Boehringer Ingelheim." While Gilotrif is expected to gain significant market share as a first-line treatment in European and Asian markets which have traditionally favoured Iressa, the US market will likely continue to be dominated by Genentech/Astellas Pharmaceuticals' Tarceva (erlotinib). Dr Xuan adds: "Gilotrif's lack of success in the US is partially attributable to its lack of clinical superiority and slightly inferior safety profile in comparison to Tarceva. Unlike Tarceva, which is a reversible inhibitor of EGFR, Gilotrif is an irreversible inhibitor of EGFR with slightly increased toxicity. "Although no direct comparison data are available for the two drugs, they are viewed to be similar in their clinical efficacy and cost. Thus, with an approval that lagged behind that of Tarceva's, Gilotrif has not been viewed as a superior option in the first-line EGFR-mutant NSCLC setting." ]]> <![CDATA[Sanofi appoints Dr Ameet Nathwani as EVP]]> https://biospectrumindia.com/news/95/8387/sanofi-appoints-dr-ameet-nathwani-as-evp.html https://biospectrumindia.com/news/95/8387/sanofi-appoints-dr-ameet-nathwani-as-evp.html Thu, 10 Mar 2016 15:38:06 +0530 Dr Nathwani will be responsible for enterprise-wide medical, patient safety, medical quality assurance and will insure the highest standard of transparency and compliance in Sanofi's interactions with healthcare providers, patients and medical organizations. He will work in cooperation with Global R&D and the Global Business Units. Dr Nathwani succeeds Dr Paul Chew who has served as Senior Vice President, Chief Medical Officer since January 2013 and plans to retire later this year. "Our industry is experiencing increased pressure to support reimbursement with customized data from real-world evidence, demonstrate ongoing benefit-risk of registered products through continuous scientific data generation, and ensure that data are effectively and transparently communicated. In order to shape Sanofi's strategy and enhance our world class medical capabilities to address these challenges we have elevated the role of the Chief Medical Officer to the Executive Committee," said Dr Olivier Brandicourt, Chief Executive Officer, Sanofi. "We are very happy to count on Ameet's strong experience in both development and medical fields. I would also like to take this opportunity to thank Paul Chew for his many valuable contributions to Sanofi. During his long-standing career, Paul has been a highly valued and key Sanofi leader who has demonstrated strong medical leadership." A UK citizen, born in Uganda and educated in the UK, Dr Nathwani has more than 20 years of experience in the pharmaceutical industry beginning in 1994 when he joined Glaxo Group Research. From the period of 1994 to 2004 he held increasingly senior global functional and franchise leadership roles in research and development in Glaxo, SmithKline Beecham and GlaxoSmithKline, both in Europe and US. He joined Novartis in 2004 as the Senior Vice President and Global Development Head of the Cardiovascular and Metabolic Franchise and over the period of 11 years has held a number of senior development and commercial positions including the Global Head of the Critical Care Business Franchise. He was appointed as Global Head of Medical Affairs Novartis Pharma AG in June 2014 and became an extended member of the Pharma Executive Committee where he led the establishment of a Real World Evidence Center of Excellence and Digital Medicine capability. Dr Nathwani qualified in medicine in 1987 in London, acquired his specialization in Cardiology at a number of University Hospitals in London, and has a diploma in Pharmaceutical Medicine and an executive Masters in Business Administration. ]]> <![CDATA[Call for nominations for BRSI Annual Awards]]> https://biospectrumindia.com/news/95/8249/call-for-nominations-for-brsi-annual-awards.html https://biospectrumindia.com/news/95/8249/call-for-nominations-for-brsi-annual-awards.html Thu, 10 Mar 2016 14:15:50 +0530 Biotech Research Society of India (BRSI) confers awards under various categories to encourage and suitably rewards its members for their scientific contributions for the work carried out in the country BRSI invites nominations for the following BRSI Annual Awards and election of Fellows: 1. Young Scientist Award: Members of BRSI of 35 years or below as on 31st December 2015 involved in Biotech R&D for outstanding contributions would be eligible. Award carries a silver medal, certificate, citation and Rs 25,000 cash. 2. Woman Scientist Award: Women members of BRSI below the age of 45 years as on 31st December 2015 involved in Biotech R&D for outstanding contributions would be eligible. Award carries a silver medal, certificate, citation and Rs 25,000 cash. 3. Life Time Achievement Award: Members of BRSI above the age of 55 years as on 31st December 2015 involved in Biotech R&D for life time contribution to the field of Biotechnology would be eligible. Award carries a silver medal, certificate, citation and Rs 50,000 cash. 4. Industrial Medal Award: Members of BRSI involved in Biotech R&D for outstanding contribution, which has resulted in commercialization of a product/process. Award carries a silver medal, certificate, citation and Rs 25,000 cash. 5. AU-CBT Excellence Awards for Research Scholars (Two awards): Members of BRSI registered for PhD studies in any Indian university/institute below the age of 30 years as on 31st December 2015 involved in Biotech R&D for outstanding performance. Award carries a citation and Rs. 5000 cash for each.6. Prof SB Chincholkar Memorial Award: Members of BRSI above the age of 40 years as on 31st December 2015 involved in R&D in the area of Food/Agriculture Biotechnology/Bioenergy for outstanding contribution. Award carries a silver medal, certificate, citation and Rs 25,000 cash. 7. Fellow of BRSI: Eminent members of BRSI having long-standing and significant contribution to the field working in various areas of biotechnology shall be considered to be elected as Fellow of BRSI (FBRS). 8. Honorary Fellow of BRSI: Eminent persons who have rendered distinguished service to the nation in Biotechnology shall be considered to be conferred as Honorary Fellow of BRSI. Award carries a citation and a memento. Nomination can be made by the members of the Board of BRSI. For this, the nominee may or may not be member of BRSI.9. SBC-MKU Genomics Award: Members of BRSI below the age of 40 years as on 31st December 2015 involved in R&D in the area of Molecular Biology/Genomics/Metabolic Engineering/Genetics/Genetic Engineering for outstanding contribution. Award carries a silver medal, certificate, citation and Rs 10,000 cash. 10. Malaviya Memorial Awards for Teaching Faculties (Two awards - one for Young Faculty below the age of 40 years and one for the Senior Faculty above the age of 40 years as on 31st December 2015): Members of BRSI working as teachers involved in Biotech R&D for outstanding contribution. Award carries a silver medal, certificate, citation and Rs 10,000 and Rs 15,000 cash, respectively. Application complete in all respects should be sent (i) by email as a single PDF file + a file with score sheet to brsi.india@gmail.com on or before 25th July 2016 and (ii) one printed copy + soft copy on CD should be sent to Dr P Binod, Central Office-BRSI, CSIR-National Institute for Interdisciplinary Science and Technology, Industrial Estate PO, Trivandrum-695 019. for more information, please contact BRSI website, http://www.brsi.in/#brsi ]]> <![CDATA[NASSCOM Foundation rallies corporates to join TB-Free India campaign]]> https://biospectrumindia.com/news/95/7835/nasscom-foundation-rallies-corporates-to-join-tb-free-india-campaign.html https://biospectrumindia.com/news/95/7835/nasscom-foundation-rallies-corporates-to-join-tb-free-india-campaign.html Thu, 10 Mar 2016 12:05:40 +0530 The corporate social responsibility (CSR) heads of India's leading companies today attended a conference organized by the National Association of Software and Services Companies (NASSCOM) Foundation in New Delhi to pledge support to the Government of India's Call to Action for a TB-Free India national campaign. Shri Anshu Prakash, Joint Secretary, Ministry of Health and Family Welfare; Dr. Sunil Khaparde, Deputy Director General, TB, Central TB Division, Revised National Tuberculosis Control Programme (RNTCP), Xerses Sidhwa, Director, Health Office, U.S. Agency for International Development (USAID); and Kavita Ayyagiri, Project Director, The Union South-East Asia, were present at the event to discuss various ways by which the corporate leaders can support the campaign, including launching TB awareness programs among employees and communities, infection control measures in the workforce, and community screening drives. The Government of India launched the Call to Action for a TB-Free India on April 23, 2015, with the goal to engage the corporate sector to further strengthen the ongoing efforts to reduce the incidence of TB and improve successful prevention, diagnosis and treatment of TB in India. According to the World Health Organization's Global Tuberculosis Report 2015, India has the largest number of TB cases in the world. Commenting on the need for private sector's support to end TB in India, Shri Anshu Prakash, joint secretary, Ministry of Health and Family Welfare underlines the immediate need for combined efforts of all stakeholders, especially the private sector, to spread the message of prevention and control of TB in all segments of the population in India, "The government alone cannot do this task. We all must join hands." Given that TB treatment is provided free of cost, the role of the private sector is to amplify and complement existing efforts. Mr Xerxes Sidhwa, USAID's director for Health Office said, "Technology and innovation are essential tools to find low-cost, financially sustainable solutions to public health challenges such as TB. USAID is working to test and scale innovative solutions that will help TB patients in underserved populations in India. We are looking forward to wide support from the private sector as we scale up these solutions not only in India but across globe." Dr Sunil D Khaparde, DDG-CTD highlighted the government's efforts in TB control and said, "Under the End TB Strategy we are aiming to reduce deaths from TB by 95 percent; a 90 percent reduction in TB incidence rate; and to ensure that no family incurs catastrophic cost for TB treatment by 2035." Dr Khaparde also asked the corporate sector to come forward and partner with CTD to develop collaborative models for engagement. Underlining the role of CSR, Ms Kavita Ayyagiri, project director, The Union South-East Asia added, "Corporates can lend their support to strengthen the existing TB control initiatives by enhancing the visibility of TB issues in corporate offices and production sites to prevent further infection; by adopting designated testing centres, prisons, slums, ART centres; by conducting TB-Free India awareness and screening drives in districts, villages, schools; by encouraging employees to get screened for TB; and adopting a workplace TB policy that doesn't discriminate against those diagnosed with TB." In February this year, the Ministry of Health had announced the launch of three important initiatives to combat TB, including the daily treatment regimen pilot in five states under which TB drugs will be administered in fixed doses daily replacing the existing three times a week treatment; purchase of 300 CBNAAT machines to conduct Rapid Molecular Tests for diagnosis of Drug-resistant TB; treatment of Multidrug-resistant Mycobacterium TB through Bedaquiline; and the TB Missed Call Initiative, a helpline with a toll-free number to provide information, counselling and treatment support services. ]]> <![CDATA[APAC's Asthma therapeutics market to hit $5.6 bn by 2021]]> https://biospectrumindia.com/features/95/1233/apacs-asthma-therapeutics-market-to-hit-5-6-bn-by-2021.html https://biospectrumindia.com/features/95/1233/apacs-asthma-therapeutics-market-to-hit-5-6-bn-by-2021.html Wed, 09 Mar 2016 17:21:13 +0530 The company's latest report states that the primary driver of this considerable rise is the prevalence of asthma across the APAC countries, which include China, India, Australia, South Korea, and Japan. The condition is burgeoning due to aging populations and increases in air pollution, dust and pollen levels, which both cause and exacerbate asthma in children. Aswini Nath, Analyst for GBI Research, says: "As well as the increasing incidence of the disease, six costly biologics are set to enter the APAC asthma market, which will push its value up considerably. These consist of GlaxoSmithKline's mepolizumab, Teva's reslizumab, Chugai/Roche's lebrikizumab, Sanofi/Regeneron's dupilumab, and AstraZeneca's tralokinumab and benralizumab. "The most advanced of these drugs is mepolizumab, which is currently at the Pre-registration stage in Japan, while the other five monoclonal antibodies (mAbs) are in Phase III development in the APAC region. As the cost of these treatments is likely to be high in comparison with more established drugs, strong uptake could well increase the cost of treatment for asthma patients." In terms of disease prevalence trends within the five APAC countries, India has the highest number of asthma sufferers. In 2014, 53.6 million people were estimated to be living with the disease, which is approximately 52.4% of the total assessed Asia-Pacific prevalence. Nath elaborates: "Lack of knowledge of the condition among the public, an increasing aging population, and increasing air and dust pollution will mean the prevalence rate will continue to rise over the period, resulting in 57 million sufferers by 2021. "Despite this, India only represented 12.2% of the APAC asthma market in 2014, which reflects the low cost of therapy in comparison with the other assessed countries." Japan, by contrast, was the largest market of the five APAC countries in 2014 at $1.8 billion, and will continue its lead to 2021, growing to $3 billion at a CAGR of 7.1%, according to GBI Research. "As Japan is ranked only third of the five countries in terms of disease prevalence, this reflects the relatively high cost of drugs, and the country's readiness to adopt promising new molecules such as the IL-targeting mAbs," the analyst concludes. ]]> <![CDATA[Lupin completes its acquisition of GAVIS]]> https://biospectrumindia.com/news/95/7768/lupin-completes-its-acquisition-of-gavis.html https://biospectrumindia.com/news/95/7768/lupin-completes-its-acquisition-of-gavis.html Wed, 09 Mar 2016 16:36:40 +0530 Pharma Major Lupin announced that it has completed its acquisition of privately held US based GAVIS Pharmaceuticals LLC and Novel Laboratories(GAVIS). Lupin had announced the acquisition on July 23rd 2015. GAVIS brings to Lupin a highly skilled US based Manufacturing and Research organization which would complement Lupin's Coral Springs, Florida based R&D center for Inhalation. GAVIS's New Jersey based manufacturing facility also becomes Lupin's first manufacturing site in the US. New Jersey based GAVIS is a privately held company specializing in formulation development, manufacturing, packaging, sales, marketing, and distribution of pharmaceuticals products. GAVIS has 62 ANDA filings pending approval with the US FDA and a pipeline of over 65+ products under development. 72 percent of these filings pending approvals represent niche dosage forms with 18 Para IVs and 8 FTFs products. GAVIS's pending approvals address a market of over $9 billion. The combined company will have a portfolio of over 120 in-market products, over 185 cumulative filings pending approval and a deep pipeline of products under development for the US. The acquisition creates the 5th largest pipeline of ANDA filings with the US FDA, addressing a $63.8 billion market. Lupin has 37 First-to-File (FTF) products which includes 17 exclusive FTF opportunities. Lupin and Gavis combined would now have over 45 FTFs. Commenting on the transaction, Ms Vinita Gupta, CEO, Lupin, said "We are very pleased to have completed our acquisition of Gavis. The Gavis portfolio augments our US business and niche generic pipeline. We plan to leverage the formulation expertise of Gavis to enhance both Lupin's generic as well as specialty pipeline." ]]> <![CDATA[Sun appoints Dhoni as Revital H brand ambassador]]> https://biospectrumindia.com/news/95/7205/sun-appoints-dhoni-as-revital-h-brand-ambassador.html https://biospectrumindia.com/news/95/7205/sun-appoints-dhoni-as-revital-h-brand-ambassador.html Wed, 09 Mar 2016 11:06:26 +0530 Sun Pharma's Global Consumer Healthcare business announced Indian cricket team captain Mr MS Dhoni as the new brand ambassador of Revital H. Mr MS Dhoni emerged as a popular choice basis a consumer research conducted by the company. MS Dhoni is a cricketer known for pushing limits and achieving more and a perfect combination of physical fitness, strategic thinking and decision making and fits well in the active lifestyle value proposition of Revital H brand. The brand has a strong hold on North, Central and East part of India and seeks to strengthen its market presence in West and South India. Twenty-five years following its launch in the Indian market, Revital H, India's leading health supplement gets a new makeover. Sun Pharma's Global Consumer Healthcare is repositioning its iconic brand for active lifestyle and being 'fit and active'. This repositioning follows a comprehensive research undertaken by the company to understand changing consumer needs. The Vitamin and Dietary Health Supplement market in India is estimated to be Rs 8,828 crore and growing at 12 percent with top 10 brands (of which Revital H is a part) in the category contributing almost 48 percent of the market revenues. According to Mr Subodh Marwah, business head - Sun Pharma Global Consumer Healthcare said, "The constant need to do more and get maximum out of every sphere of live is what's driving the increasing preferences for health supplements across India. Thus, in order to appeal to this emerging lifestyle context as well as the evolving consumption patterns in this category, we are repositioning Revital H for active lifestyles. This further builds upon its energy-building proposition. Basis our rich consumer understanding, the repositioning of Revital H from just physical energy to active lifestyle that requires physical energy as well as mental agility will enable the brand to become a holistic good health partner in everyday life." Commenting on this association, Indian cricket captain Mr MS Dhoni said, "Given the hectic and active lifestyle that we all live today, it becomes extremely important to ensure that our body is receiving the right amount of nutrition. Revital H fills the gap and helps stay healthy. Remaining fit and active is everybody's right and not just the sole domain of professional athletes. I strongly believe that the new brand positioning of Revital H will strongly resonate with the active generation of today's India and become a part of their everyday life. I am very happy to be associated with this brand and look forward to working with them closely." ]]> <![CDATA[Mylan's health hackathon focus on delivering better health for a better world]]> https://biospectrumindia.com/news/95/7891/mylans-health-hackathon-focus-on-delivering-better-health-for-a-better-world.html https://biospectrumindia.com/news/95/7891/mylans-health-hackathon-focus-on-delivering-better-health-for-a-better-world.html Tue, 08 Mar 2016 16:55:58 +0530 Mylan NV announced that the company will host a health hackathon at its Global Center in Bengaluru on March 19-20, 2016. The event will focus on Better Health for a Better World. Participants in the hackathon will be creating innovative solutions for patients, payers, providers and other healthcare professionals. Mylan conducted a similar event last month at its Global Center near Pittsburgh. Hackathon teams will build solutions to answer a variety of healthcare challenges, such as overcoming obstacles to HIV treatment in emerging markets, leveraging existing technology to increase Indians' access to healthcare, and accessing public datasets and application programming interfaces to build insights about diseases. Mylan's President Mr Rajiv Malik said, "As a company committed to setting new standards in healthcare, we are excited to host hackathons that can help launch a new generation of solutions capable of delivering better health for a better world. In addition, we look forward to welcoming hackathon participants to our new Global Center in Bengaluru, which we opened in 2015 to help support Mylan's extensive and growing presence in India. The country currently is home to nearly half of our workforce and more than half of our manufacturing facilities." ]]> <![CDATA[Merck appoints Sanat Chattopadhyay as VP, President ]]> https://biospectrumindia.com/news/95/7581/merck-appoints-sanat-chattopadhyay-as-vp-president-.html https://biospectrumindia.com/news/95/7581/merck-appoints-sanat-chattopadhyay-as-vp-president-.html Tue, 08 Mar 2016 15:03:00 +0530 Singapore: Merck has appointed Sanat Chattopadhyay as executive vice president and president of Merck Manufacturing Division (MMD), effective April 1, 2016. Chattopadhyay will succeed Willie A Deese who will retire on June 1, 2016 after 12 years with the company. With more than 30 years of biopharmaceutical industry experience, Sanat has a proven track record of commercialization, manufacturing and supply chain excellence in therapeutic proteins, vaccines and pharmaceuticals. Under his leadership I am confident that MMD will continue to advance toward its goal of becoming a world-class supplier," said Kenneth C. Frazier, chairman and chief executive officer, Merck. Mr Chattopadhyay joined Merck in 2009 and currently serves as senior vice president of Global Manufacturing Operations (Human Health). He was instrumental in transforming Merck Vaccines' manufacturing and supply to grow and globalize the company's vaccines business. Chattopadhyay also played a key part in leading the company's launch of KEYTRUDA (pembrolizumab) in record time by mobilizing a cross-divisional effort to overcome commercialization and supply constraints. ]]> <![CDATA[Merial, Zoetis enter into strategic agreement for dairy products]]> https://biospectrumindia.com/news/95/7454/merial-zoetis-enter-into-strategic-agreement-for-dairy-products.html https://biospectrumindia.com/news/95/7454/merial-zoetis-enter-into-strategic-agreement-for-dairy-products.html Tue, 08 Mar 2016 11:46:34 +0530 Merial, the animal health division of Sanofi, and Zoetis India, a subsidiary of Zoetis announced that they have entered into an exclusive marketing and distribution agreement for medicines and vaccines for Dairy cattle in India. Merial will market and sell Zoetis' products, including global/local brands such as Bovical, Lutalyse, Xnel Dectomax and vaccines like Rispoval and Spirovac. The products will be marketed by Merial India beginning in April 2016. Financial details of the agreement were not disclosed. "The newly added products complement Merial's existing ruminant business in India, which includes vaccines, therapeutics and nutritionals. It increases our presence in the important dairy segment and expands our current product offerings. We now have a robust portfolio that has strong customer loyalty, making us a key player in the rapidly growing India ruminant market," said Dr Sandeep Karkhanis, country manager, Merial India. "For Merial, this agreement reinforces the strategic importance of India and the animal health market in the country. We plan to keep our focus and investment in product innovation, acquisitions and alliances, growth areas and services to meet the evolving needs of our customers." In India, Merial has a diversified local portfolio of over 50 brands comprising of vaccines, therapeutics and nutritional products for ruminants, poultry and pets. Mr Ketan Dhamanaskar, managing director, India, GM South Asia, Zoetis, added, "This agreement helps both companies use the strengths of our product portfolios and market strategies to grow in a more effective way. Zoetis' leading dairy brands and innovative vaccines, combined with the strong distribution reach and presence of Merial in India, will enable us to make these products available in the most efficient manner in the Indian market. As a result of this arrangement, Zoetis India Limited will also be able to focus its field force and resources on building a stronger presence and market leadership in the Poultry and Companion Animal sectors in India, which grew at 18.6 and 12.8 percent respectively in 2015." India is the world's largest milk producer, with 16 percent of global production. Therefore, presence in the ruminant business is strategically important for Merial in India as it constitutes 54 percent of the animal health market in the country. The Dairy sector continues to be a major livelihood source for rural India and a significant contributor to the country's agricultural economy. As per the industry estimates, the share of value added dairy products in the milk and milk derivatives segment is growing by around 25 percent every year and is expected to continue to grow at the same rate until 2019-204. India is the sixth largest chicken producing country in the world with annual production of more than 2 billion broilers and is the third largest egg producing country with 4 Million+ metric tons eggs produced in 2015. The India poultry market is expected to grow at 14.4 percent in the next five years. Consumption of poultry meat and eggs also witnessed bourgeoning growth at 2.7 to 4.2 percent year on year in the past 5 years and is expected to grow at an accelerated pace in the next five years. ]]> <![CDATA[WNS extends contract with GSK till 2020]]> https://biospectrumindia.com/news/95/8064/wns-extends-contract-with-gsk-till-2020.html https://biospectrumindia.com/news/95/8064/wns-extends-contract-with-gsk-till-2020.html Mon, 07 Mar 2016 14:22:16 +0530 WNS (Holdings), provider of global Business Process Management (BPM) services, announced that it has extended its service contract with global pharmaceutical leader GlaxoSmithKline (GSK) until December 2020. "....For more than a decade, WNS has been a trusted partner driving evidence-based decisions through high-end research and analytics services. Under the agreement with GSK, WNS has set-up a dedicated state-of-the-art Knowledge Center, driven by a team of over 600 industry experts. WNS leverages its deep Pharma domain knowledge, robust analytics capabilities and proprietary frameworks to deliver actionable business insights to GSK," said Mr Keshav R Murugesh, Group CEO, WNS. ]]> <![CDATA[Strides acquire 3 brands from Moberg Pharma for $10 Mn]]> https://biospectrumindia.com/news/95/8278/strides-acquire-3-brands-from-moberg-pharma-for-10-mn.html https://biospectrumindia.com/news/95/8278/strides-acquire-3-brands-from-moberg-pharma-for-10-mn.html Mon, 07 Mar 2016 14:21:04 +0530 Strides Shasun today announced that its wholly-owned subsidiary Strides Pharma Inc. has entered into an agreement with Moberg Pharma, Sweden, and its affiliates to acquire Jointflex, Fergon and Vanquish brands for a total consideration of $10 million plus inventory value at closing. The transaction adds $ 6.1 million of revenues and delivers above company EBITDA margins. Recent acquisitions has enabled Strides Shasun build an emerging OTC franchise both in its regulated and emerging markets. The announced acquisition strengthens Strides Shasun's strategy to build a global OTC franchise. The OTC portfolio now includes market leading Chemists Own umbrella brand in Australia and Nuprin in the US, acquired by erstwhile Shasun from Scolr Pharma, US. Nuprin has the global rights to the first Ibuprofen 12-hour Extended-Release (ER) tablets, as well as the associated Controlled Delivery Technology (CDT). The company has also filed ANDA's that will further enhance the OTC portfolio in the US. The Moberg brands that are currently marketed in USA, Australia and Middle-East will further strengthen the OTC business. The OTC business has now reached a critical size and is showing promise to become an important part of the overall growth strategy. ]]> <![CDATA[India becomes second EMBO Associate Member State]]> https://biospectrumindia.com/news/95/7427/india-becomes-second-embo-associate-member-state.html https://biospectrumindia.com/news/95/7427/india-becomes-second-embo-associate-member-state.html Mon, 07 Mar 2016 12:29:17 +0530 The Government of India through the Department of Biotechnology (DBT), Ministry of Science and Technology, EMBO and its intergovernmental funding body, the European Molecular Biology Conference (EMBO), have signed a Cooperation Agreement to strengthen scientific interaction and collaborative research between India and Europe. After the signing of an agreement with Singapore in July 2015, India will now become the second country to acquire the status of EMBC Associate Member State. The goal of the agreement is to boost Indo-European exchange and to provide a platform for interaction with top-level scientists on both sides. As an EMBC Associate Member State, researchers working in India are now eligible to participate in all EMBO programmes and activities. Indian scientists can apply to EMBO's programmes, such as long-term fellowships for postdoctoral researchers, short-term fellowships, courses and workshops, as well as the EMBO Young Investigator Programme. At the same time, Europe will benefit from networking with the top-level scientists in India's research community. Deeper cooperation between nations will stimulate vision, ideas, and provide a framework for a long-term partnership. "For the past five years, we have been promoting international interactions beyond Europe, and India is one of our prime partners. I am extremely pleased that India is going to be an Associate Member of EMBC and I look forward to India being able to access EMBO activities. Many European researchers have established scientific connections in India. No doubt these will be strengthened further once more tools and formal opportunities for interactions are available," highlighted Professor Maria Leptin, director of EMBO. "India is rapidly growing into a position where we are making extraordinary demands on ourselves. India can only succeed if we partner with the best everywhere to bring the best here," he added. "Through EMBO, we will not only have the excellent joint programmes that benefit India and Europe, but we hope to be a magnet that attracts bright young people to science from in- and outside India," said professor K. Vijay Raghavan, secretary of DBT, for the Government of India, who signed the agreement. Professor Gerrit van Meer, president of the EMBC, remarked, "All member states welcome the exchange with Indian scientists that this agreement will bring. We look forward to seeing transcontinental projects spanning India and Europe grow in future." An official launch ceremony will be held in Delhi, India, on 4 February 2016. The kick-off event will include scientific presentations by Nobel Laureates Christiane NÃ¼sslein-Volhard and Ada E. Yonath. An EMBO-led delegation of ten researchers will visit various institutes across the country and meet with Indian scientists and government representatives. The newly forged cooperation will build upon already existing links between Indian and European scientists. In 2015, 10 Indian postdoctoral researchers received an EMBO Long- Term Fellowship to work in Europe and eight India-based scientists received the EMBO Short-Term Fellowship. A satellite symposium focusing on research in India has been an integral part of the annual conference The EMBO Meeting. ]]> <![CDATA[Prof. Satyajit Mayor awarded the Margdarshi fellowship ]]> https://biospectrumindia.com/news/95/8308/prof-satyajit-mayor-awarded-the-margdarshi-fellowship-.html https://biospectrumindia.com/news/95/8308/prof-satyajit-mayor-awarded-the-margdarshi-fellowship-.html Fri, 04 Mar 2016 12:00:52 +0530 The Margdarshi fellowship enables established, senior scientists to nucleate and lead novel research programs in India. The principal mandate of the program is to generate contemporary centres of excellence by employing innovative approaches, creating new infrastructure and building collaborations in frontier areas of science. The fellowship is aimed at using the expertise of a visionary scientist to seed new areas of research in India by mentoring young researchers while also building partnerships both within the Indian scientific community and globally. Prof. Mayor is one of only three recipients of this international and highly competitive scheme awarded by the Wellcome Trust/DBT India Alliance. Prof. Mayor has been working on understanding the structure and function of the cell membrane for nearly two decades. Using a combination of diverse approaches such as theoretical soft-matter physics (in collaboration with Prof. Madan Rao), chemistry and cell biology, his research has focused on the dynamics of membrane function, especially those associated with receptor signalling and membrane traffic. Prof. Mayor's work has resulted in a deeper understanding of the importance of endocytosis in cellular and tissue functions - including the self-organising mechanisms of local membrane environments that fine-tune signalling processes in the cell. There are however, a range of questions across several scales that have been generated by these insights into cell membrane dynamics - questions that require the support of a Margdarshi fellowship in order to be addressed. At a local or mesoscopic scale, in the order of nanometers, receptors are known to regulate local lipid compositions in the cell membrane via cell cytoskeletal elements. In order to test hypotheses about the mechanisms by which these phenomena occur, in vitro membrane systems need to be constructed using cell membrane components. At the micron scale, questions involving changes in the composition of specific parts or even the entire cell membrane need to be addressed. In this, lipidomics assays would allow investigation of the roles played by exo-endocytic pathways, lipid trafficking systems and diet on membrane compositional alterations. Variations in local and global membrane compositions affect physiological processes such as stem cell differentiation. In order to understand the regulation and functional aspects of local and global membrane organisation, a deeper insight into the machinery that links membrane proteins and lipids to the cell cytoskeleton is also needed. "The scope and vista of possibilities that an award of this kind opens up are extremely exciting, and I am delighted to receive this prestigious fellowship, since it takes the foundation that we have built to the next level. I am very excited to probe how a cell regulates its membrane composition, and programme support from the DBT-Alliance that this fellowship offers is just the right thing that can help build the platform for this interdisciplinary research", says Prof. Mayor. To initiate such investigations, novel approaches involving joint efforts from various fields are required. Prof. Mayor's proposed investigations will establish and strengthen collaborative links between his team and other researchers from within NCBS, the Regulation of Cell fate theme at inStem, as well as across world-class institutions like the Max Planck Institute of Molecular Cell Biology and Genetics, Dresden and the Centre for Genomic Regulation (CRG), Barcelona. The Bangalore Life Science Cluster with its state-of-the-art facilities in cell and molecular biology, high-end imaging systems, proteomics and lipidomics analysis capabilities is an ideal host institution to support these new directions and the collaborative links are expected to facilitate many of the research directions envisaged via the new award. "We are delighted with the award of the Margadarshi fellowship to Jitu Mayor, a recognized leader in the field of membrane biology. This program brings an exciting new direction to Jitu's research and truly reflects his ability to set up interdisciplinary team efforts and his scientific engagement, which have fostered collaborations across the world. At a more personal level, it's a great opportunity for the nascent Regulation of Cell Fate theme at inStem to be associated with this venture, as Jitu can almost always be relied upon to push the frontiers of any problem that he works on! This prestigious fellowship, also recognizes the very fine body of work accomplished over the years by his lab at NCBS and inStem is proud to co-host with NCBS the first such fellowship awarded to the campus", says Prof. Apurva Sarin, Dean of inStem. "I'm delighted that Prof. Mayor's research has been recognized and supported by the India Alliance and the Margdarshi award. The proposed research takes an already impressive programme on membrane function in cell biology to a new level. I look forward to this catalyzing many new kinds of science on campus through collaborations and new experimental models that cut across multiple scales of investigation," says Prof. Upinder Bhalla, Dean of NCBS. (Source:InStem News) ]]> <![CDATA[India, US partner on cancer and traditional medicine research ]]> https://biospectrumindia.com/news/95/4211/india-us-partner-on-cancer-and-traditional-medicine-research-.html https://biospectrumindia.com/news/95/4211/india-us-partner-on-cancer-and-traditional-medicine-research-.html Fri, 04 Mar 2016 11:40:03 +0530 The first US-India Workshop on Traditional Medicine (March 3-4, 2016) began in New Delhi. The Workshop was jointly inaugurated by the Minister of State for AYUSH (Independent Charge) and Health and Family Welfare, Shri Shripad Yesso Naik and US Ambassador to India, Mr Richard Verma and Assistant Secretary of Global Affairs at HHS, Ambassador Jimmy Kolker. Representatives from the US Department of Health and Human Services (HHS) Office of Global Affairs (OGA), the National Institutes of Health (NIH) National Cancer Institute (NCI), and US academic institutions will interact with their counterparts from the Ministry of Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homoeopathy (AYUSH), and Indian research institutes and universities, in New Delhi during the workshop. The Workshop is being organized under the auspices of the first US-India Health Dialogue held in September, 2015 in Washington, D.C. This effort underscores the discussions between the U.S. President and the Indian Prime Minister to encourage bilateral dialogue on traditional medicine. Over the course of the two-day workshop, participants will share current traditional medicine therapies and practices for cancer in US and India. They will review available evidence for AYUSH products and interventions, which could reduce pain/morbidity from cancer treatments and improve the quality of life. Scientists will explore opportunities to collaborate on mutually-identified research in the areas of natural products, palliative care and other support studies. Professional training and scientific exchanges will be an important aspect of this cooperation. Addressing the participants, the AYUSH Minister, Shri Shripad Naik said that globalization of AYUSH is one of the major policy thrusts of our Government. The constructive collaboration between India and US in this field is important for incorporating more scientific inputs from both sides in Traditional Medicines which can help mainstreaming AYUSH systems in patient health care across the globe. India is also collaborating with World Health Organization (WHO) in the area of Traditional Medicine which will help in achieving international acceptability and positioning of AYUSH systems, the Minister explained. "Today's workshop supports the important deliverable from the President Obama-Prime Minister Modi Joint Statement and U.S.-India Health Dialogue, where both India and the US agreed to explore further potential areas of mutual collaboration on Indian Traditional Medicine," said Mr Richard Verma, US Ambassador to India. "This meeting demonstrates the commitment of HHS to support bilateral cooperation on cancer and traditional medicine research, with science at the cornerstone," said Ambassador Mr Jimmy Kolker, Assistant Secretary of Global Affairs at HHS. "This is a great opportunity to bring to the table from the US side NCI and NIH expertise in laboratory and clinical evaluation of traditional medicine and from the Indian side an impressive commitment to building the evidence base for traditional Indian medicine," said Dr Edward Trimble, Director of the US NCI's Center for Global Health. Secretary AYUSH, Shri Ajit Mohan Sharan informed that the International Cooperation Division in the Ministry has been asked to work proactively to forge such collaborations so that large sections of people can benefit from AYUSH systems. The US delegation also visited several Indian institutes - Benares Hindu University, Jamia Hamdard University, All India Institute of Ayurveda and Medanta - The Medicity, to learn first-hand how Traditional and Modern Medicine co-exist for patient-care. Nearly 175 participants including experts related to both traditional systems and modern medicine, biologists, and researchers from India and the US will take part in the two day Workshop. These discussions will be strengthened at the next US-India Health Dialogue this year in India. ]]> <![CDATA[Horizon Discovery partners with Centauri Therapeutics ]]> https://biospectrumindia.com/news/95/7439/horizon-discovery-partners-with-centauri-therapeutics-.html https://biospectrumindia.com/news/95/7439/horizon-discovery-partners-with-centauri-therapeutics-.html Fri, 04 Mar 2016 11:38:40 +0530 Horizon Discovery Group announces that it has formed an immuno-oncology joint venture, Avvinity Therapeutics with Centauri Therapeutics, a UK-based biotechnology company focused on the discovery and development of novel molecules targeting life-threatening infectious diseases. This transaction represents part of Horizon's previously outlined strategy to invest up to £10 million,(approx. $14.5 million) further leveraged by its IP, technology platforms and know-how, to identify the next generation of molecular and cellular cancer therapeutics. Avvinity will combine Horizon's gene editing, immunology, oncology and drug discovery capabilities with Centauri's Alphamer technology to provide a powerful and proprietary platform to discover and develop novel immuno-oncology therapeutics, for both solid tumours and leukaemias. Under the terms of this agreement, Horizon will out-license certain background intellectual property relating to its translational genomics and drug discovery platforms, and will invest up to £5.3 million (approx. $7.5 million) over two tranches with the first tranche of £2.5m ($3.5 m) committed, and the second to be committed at Horizon's discretion pending the progress of three development programs. Centauri will license background IP and expertise on its Alphamer technology to Avvinity, which will have exclusivity for the field of oncology for an initial three year period and can be extended via the issue of further equity concurrently with the raise of new investment. Avvinity will be managed jointly by Horizon and Centauri, and based on the investment of IP, technology and the first tranche of funding; Horizon will own 33 percent of Avvinity's equity, representing 50 percent of the most-preferred class of voting shares. Upon completion of the 2nd tranche of funding Horizon will own 49.99 percent of Avvinity's equity, representing 50 percent of the most-preferred class of voting shares. The joint venture will be managed within Horizon as part of the Company's Research Biotech business (formerly Horizon's Leveraged business unit). Neither Horizon nor Centauri will be obliged to provide further funding to Avvinity, though both retain pre-emption rights and may elect to participate in future funding rounds. Subject to achieving key development milestones, Avvinity plans to raise significant new external investment to take its innovative drugs into clinical trials, at which time the value of Horizon's stake in the business would be highly-material. Dr Darrin M Disley, CEO, president research biotech of Horizon Discovery Group said, "By combining Horizon's deep understanding of the genetic basis of cancer alongside its gene editing, drug discovery and emerging immuno-oncology toolbox, with Centauri's unique Alphamer technology and knowledge of its use, we have created an exciting new company to spearhead Horizon's move into targeted therapeutic development. We are confident this joint venture will break new ground in the development of immunotherapies, and bring significant value creation to Horizon shareholders. The establishment of Avvinity is in line with our hybrid Research Biotech strategy to not only work with partners but also take advantage of the therapeutic upside potential of the most exciting new areas of personalised and genomic medicine in a risk-managed way." Dr Mike Westby, CEO of Centauri Therapeutics, commented, "Alphamers are an entirely novel way to target disease and represent an exciting new approach for recruitment of host immunity. At Centauri we have invested to build the Alphamer platform and assembled the drug discovery expertise necessary to exploit the platform in infectious diseases. Through this joint venture with Horizon, we look forward to applying our combined know-how and capabilities to develop Alphamers as important new immuno-oncology medicines, particularly for cancer indications that have proven intractable to date." ]]> <![CDATA[Pfizer launches Gelusil sachet]]> https://biospectrumindia.com/news/95/4212/pfizer-launches-gelusil-sachet.html https://biospectrumindia.com/news/95/4212/pfizer-launches-gelusil-sachet.html Fri, 04 Mar 2016 11:36:46 +0530 Pfizer's GEP (Global Established Products) division in India announced the launch of its largest selling antacid Gelusil liquid in a ready-to-drink, on-the-go sachet format. The sachet aims to reach out to consumers who are constantly on the go and have to rely on multiple elements of cure to settle the acidity attacks. Being rolled out in metros, smaller towns and rural areas simultaneously, the Gelusil sachet is available across pharmacy stores and is priced at Rs 8/- per sachet. Commenting on this launch, Mr Partha Ghosh, senior director (Global Established Products) said, "Acidity can be a recurring condition which can strike anyone, anytime, anywhere. It can cause heartburn and serious discomfort which can impact normal work. Research reveals that many who suffer from acidity do not take it seriously and either ignore it or resort to traditional methods to deal with acidity attacks. While traditional methods may provide symptomatic relief, it does not address the real issue. Gelusil's balanced formula not only provides instant relief by neutralizing the acid secreted but also provides long lasting relief by protecting the stomach lining from damage due to excessive acid." This newly launched easy-to-carry sachet has a unique proposition of a ready-to-consume solution for acidity that does not require water or a glass. It's tamperproof packaging makes it convenient to carry and consume it just anytime / anywhere. "We noticed that today's on-the-go generation needs something that is easily accessible and portable. As a leading brand in the category it is important that we continuously look for newer and better ways of meeting the ever changing needs of the consumer. That's how the idea of a sachet was born," added Mr Ghosh. Hurry, worry or curry can lead to acidity attacks. If you cannot avoid them, make Gelusil sachet your ally and be ready for the next party. ]]> <![CDATA[Once-a-week drug for Type 2 diabetes launched by Lilly India]]> https://biospectrumindia.com/news/95/6978/once-a-week-drug-for-type-2-diabetes-launched-by-lilly-india.html https://biospectrumindia.com/news/95/6978/once-a-week-drug-for-type-2-diabetes-launched-by-lilly-india.html Thu, 03 Mar 2016 15:53:00 +0530 Eli Lilly and Company announced the launch of its recently approved diabetes treatment Trulicity (dulaglutide) in India. Trulicity is the first once-weekly, injectable medication designed to improve blood sugar control in adults with type 2 diabetes. Trulicity is part of a class of drugs known as a glucagon - like peptide (GLP-1) receptor agonists. It is not insulin and mimics the effects of GLP-1, a natural hormone that helps keep blood sugar levels normal, by helping the body release its own insulin after food intake. Trulicity (dulaglutide) comes in an easy to use, single-dose pen that does not require mixing or measuring and can be administered at any time of the day, independent of meals. "Diabetes is a big burden on the healthcare system in India. Millions of Indians live with diabetes and have diverse needs", said Edgard Olaizola, Managing Director, Lilly India. He added, "Trulicity is an important addition to our diabetes portfolio in India and this launch is an important milestone in our journey to help a large number of patients and their caregivers. Dr. Tarun Puri, Medical Director, Lilly India said, "The GLP-1 agonist class provides several benefits including a proven efficacy in controlling blood sugar levels with a lower risk of hypoglycemia (low blood sugar). It might even help patients reduce a little weight" India is among the first few countries in the world and only third in Asia (after UAE and Japan) to launch Trulicity. It received US FDA approval in September 2014 and EU approval in November 2014. Trulicity is a prescription drug that should be taken only on prescription from a registered MD (Internal Medicine) and Endocrinologist. When prescribed, it should be used as an adjunct to diet and exercise. ]]> <![CDATA[8th edition of Bangalore India Nano 2016 inaugurated]]> https://biospectrumindia.com/news/95/3943/8th-edition-of-bangalore-india-nano-2016-inaugurated.html https://biospectrumindia.com/news/95/3943/8th-edition-of-bangalore-india-nano-2016-inaugurated.html Thu, 03 Mar 2016 13:07:32 +0530 The 8th edition of India's flagship nanotechnology and nanoscience event Bangalore India Nano 2016, observed a splendid opening today. An initiative powered by Department of IT, BT, and S&T, Government of Karnataka and vision group on Nanotechnology, this one of its unique event that is a refind blend of academia, research and industry to showcase never seen before nanotechnology applications. The inaugural ceremony was attended by S R Patil, Minister for IT, BT, S&T, and Planning & Statistics, along with the Chairman of the Vision group on Nanotechnology Bharat Ratna Prof. CNR Rao, Ms. Manjula, Principal Secretary, Department of IT, BT, S&T, Government of Karnataka, Prof. Dr. Clement Sancanchez, Chair-Chemistry of Hybrid Materials, College de France-UPMC and Professor Ajay Kumar Sood, Department of Physics, Indian Institute of Science. In his inaugural speech, S R Patil Minister for IT, BT, S&T, and Planning & Statistics, Government of Karnataka urged entrepreneurs to set up Nanotechnology start ups in Karnataka, particularly in Bangalore. "It is believed that Nano applications are limitless. The state government has set up regional science centers in various parts of the state. entrepreneurs can make use of these facilities. Also it is our government endeavor to make Bangalore a cradle of Nano technology", he said. Prof CNR Rao said that Time has come to get results in India. "One has to do good work on Nano-produce new science and take Bangalore Nano to new heights and create new revolution". During the inaugural function Prof. Dr. V Ramgopal Rao received the Prof. CNR Rao Bangalore India Nano Science Award for the exceptional work carried out in the Nano electronic space. Prof. Ramgopal Rao is a P K Kelkar Chair Professor in the department of Electrical Engineering and Chief Investigator for the Center of Excellence in Nanoelectronics project at IIT Bombay. The Bangalore India Nano conference would address the latest trends in Nanotechnology covering Healthcare, Clean Water, Energy, Manufacturing, Research Industry Collaboration Hub, Keynote lectures over 13+ sessions and will see participation of over 600 delegates from across 9 countries with participation of over 200 organizations. Bangalore India Nano 2016 will also comprise a Research Industry Collaboration (RICH)-a unique platform designed for the benefit of young researchers, emerging entrepreneurs and is expected to be attended by potential investors, heads of large R&D labs, venture capitalists and industry captains. Additionally, the three day event will feature product and Technology exhibition showcasing innovative nanotechnology adopted by over 45 exhibitors in Nanotechnology and allied sectors. The other major highlight include 'Nano Sparx', a platform for students to PhD scholars to encourage entrepreneurship in Nanotechnology where ideas are presented on Nanotechnology with which social relevance. Last day of the event would feature Tutorials on Nano Fabrication Technologies; Nano Medicine; Electron Microscopy and Nano Photobics. ]]> <![CDATA[Experts stress on need for timely intervention for hearing impairment in children]]> https://biospectrumindia.com/news/95/6976/experts-stress-on-need-for-timely-intervention-for-hearing-impairment-in-children.html https://biospectrumindia.com/news/95/6976/experts-stress-on-need-for-timely-intervention-for-hearing-impairment-in-children.html Thu, 03 Mar 2016 13:00:21 +0530 As a prelude to International Ear Care Day (March 3), PD Hinduja Hospital and MRC in association with Indian Academy of Pediatrics and ihear foundation (IHF) conducted a seminar on 'Current concepts in hearing impairment and Cochlear Implants' for Pediatricians. The seminar was spearheaded by Dr Milind Kirtane, Consultant ENT Surgeon, PD Hinduja Hospital and his team. Since the WHO theme this year is 'Childhood hearing loss: act now, here is how!' the focus of the session was on the role of pediatricians in early diagnosis of hearing impairment in children and need for early intervention with Cochlear Implants. Padma Shri recipient Dr Milind Kirtane highlighting the importance of awareness on hearing impairment and early detection said, "About 1-6 per 1000 infants are born with significant hearing loss. We believe that timely detection of hearing impairment, followed by early intervention with hearing aids or cochlear implantation as indicated can help such children hear and live a normal life. Through the IHF, we aim to train professionals for early detection and early intervention. I feel that hearing test should be made mandatory among newborns in India as it is in the West." Dr Kirtane has performed more than 2000 successful cochlear implant surgeries across India and over the past several years has trained over 100 surgeons through workshops on cochlear implants and helped many of them establish their own cochlear implant programs at several hospitals including municipal and government. Speaking during the seminar, Dr Samir Dalwai, National Chairperson, Indian Academy of Pediatrics (IAP) said, "Children with profound hearing loss are normal, intelligent and much capable of blossoming into able and confident individuals. It is vital for the parents and family members to understand the smallest hints of hearing loss and take speedy action. With technological advancements we can now conduct procedures and transform lives but timely intervention is important. Pediatricians across the country could play a significant role in early diagnosis of hearing impairment in children." Interesting topics discussed during the day: concerns over hereditary hearing loss among children, complications arising from hearing impairment, correlation between hearing loss and epilepsy, impact of hearing loss on nervous system, multi-disciplinary intervention in hearing impairment, challenges in treatment of hearing issues among children, surgical advancements in hearing restoration, benefits of mandatory hearing tests among newborns. The seminar concluded with a panel discussion chaired by Dr Milind Kirtane on "how pediatricians can play a role in early detection of hearing impairment in infants". The experts who participated were Dr Waheeda Pagarkar, â€?Audiovestibular Physician from UK; Dr Vrajesh Udani, Pediatric Neurologist; Dr Neelu Desai, Pediatric Neurologist and Epileptologist; Dr Soonu Udani, Pediatrician; Dr Mamta Muranjan, Consultant Clinical Genetics; Ms Nishita Mohandas, Audiologist. ]]> <![CDATA[Nanotech accelerates Precision Medicine evolution: F&S]]> https://biospectrumindia.com/news/95/5740/nanotech-accelerates-precision-medicine-evolution-fs.html https://biospectrumindia.com/news/95/5740/nanotech-accelerates-precision-medicine-evolution-fs.html Wed, 02 Mar 2016 14:26:29 +0530 The remarkable progress made in medicine and wellness over the last ten years is partially due to the radical advances made in nanotechnology. This technology's core healthcare applications include nanomedicine, nanobiosensing, nano self-assembly and life sciences, especially in the areas of precision targeted therapies, high-sensitivity chips, nano arrays and next-generation biomarkers. New analysis from Frost & Sullivan, Trends in Nanomedicine, identified unprecedented levels of innovation in nanomedicine. There have been notable developments in diagnostics, therapeutics, companion diagnostics, regenerative medicine and many other applications that are linked to the concept of precision medicine. "New nano formulations for targeting tumors, soft nanomaterials for bone regeneration and implantable devices for localized delivery of drugs have all given a huge boost to precision medicine," said TechVision Industry Analyst Ms Cecilia Van Cauwenberghe. "Other innovations such as nanostructured surfaces for biosensors, image-guided implantation of advanced neurostimulators, 3D nanomaterials for stem cell immobilization and intelligent bioactive materials will usher in a new era of healthcare." Nanomedicine facilitates personalized medicine in many ways. For instance, nano-based diagnostic tests or nano-imaging diagnosis may aid in the stratification of patients and thereby, guarantee personalized, patient-centered therapy. In addition, they make clinical protocols simpler, more efficient and affordable. The inventions in nanomedicine have mostly benefitted the areas of immuno-oncology, inflammation, neurological disorders, cardiovascular and metabolic disorders, hematology, respiratory and infectious diseases. At present, there are more than 200 nanomedicine products at various stages of clinical trials, and more than 150 commercially available solutions. This number will increase substantially in the next five years, along with the number of market entrants. There have been parallel trends in biotechnology with the rollout of protein polymers from natural sources. These materials are finding considerable application in the construction of novel nanocarrier systems and the rational design of protein nanoparticles based on the behavior of nanoparticles in the tumor microenvironment. Although the industry is buzzing with activity, many nanoplatforms developed for cancer therapy have not progressed past Phase II of clinical trials and very few have obtained Food and Drug Administration (FDA) approval. The heavy investments required for R&D and clinical trials, complexity of manufacturing and regulatory challenges has necessitated external funding, at least until the processes are standardized. "Importantly, nanomedicine has been able to attract sizeable public and private investments due to the escalating prevalence of cancer, orthopedic, cardio/neurovascular and metabolic disorders, and an aging population," noted Ms Van Cauwenberghe. "In addition to large pharmaceutical companies, nanotech-based companies are also demonstrating a keen interest in tapping the healthcare industry." Trends in Nanomedicine, part of the TechVision (Health & Wellness) subscription, studies the emerging trends in nanomedicines on a global scale, through a detailed strategic assessment of the industry environment. Frost & Sullivan's expert analysts thoroughly examine disease diagnosis and therapies, regenerative medicine, drug delivery systems and health monitoring, among many other tools closely related to precision medicine. Frost & Sullivan's global TechVision practice is focused on innovation, disruption and convergence and provides a variety of technology-based alerts, newsletters and research services as well as growth consulting services. ]]> <![CDATA[Breast cancer: Only pharma pipeline with 1k drugs in development]]> https://biospectrumindia.com/features/95/6023/breast-cancer-only-pharma-pipeline-with-1k-drugs-in-development.html https://biospectrumindia.com/features/95/6023/breast-cancer-only-pharma-pipeline-with-1k-drugs-in-development.html Wed, 02 Mar 2016 12:29:47 +0530 The breast cancer treatment pipeline's exceptional levels of activity and innovation, with a staggering 1,050 drugs in active development across all stages and 347 first-in-class programs, may significantly alter the clinical and commercial landscape of the disease market over the next decade, according to business intelligence provider GBI Research. The company's latest report states that factors driving such innovation and potential for breakthrough drugs include a very large and growing patient pool, a well-established market with multiple unmet needs, and a robust understanding of the disease pathophysiology, facilitating the development of novel compounds that may fill such needs. Mr Dominic Trewartha, Managing Analyst for GBI Research, explains: "Breast cancer has the largest product pipeline in the pharmaceutical industry, and its significant patient population and successful commercialization of drugs such as Herceptin have attracted a great deal of R&D investment. "The sheer number of first-in-class products in development reflects a deepening scientific understanding of the underlying pathophysiology of breast cancer and a growing list of molecules that have been implicated in the initiation and progression of the disease. "Although the development of products for novel molecular targets is risky, as their role in disease pathophysiology is often poorly characterized, the breast cancer pipeline also has the potential to yield therapies that outperform existing products and mechanisms of action." While the cure rate for early-stage breast cancer is currently high, and the safety and tolerability profiles of existing monoclonal Antibodies (mAbs) are strong, more advanced forms of the disease, such as metastatic cancer, are not so treatable. Mr Trewartha explains: "Due to the highly complex and polygenic nature of breast cancer, it is unlikely that the inhibition of a single target will be sufficient to substantially improve the prognosis in the clinic. "However, it is far more likely that the concurrent use of multiple targeted therapies, along with other available modes of therapy, will be able to do this, which will positively change the clinical landscape." ]]> <![CDATA[Piramal launches throat spray]]> https://biospectrumindia.com/news/95/7173/piramal-launches-throat-spray.html https://biospectrumindia.com/news/95/7173/piramal-launches-throat-spray.html Wed, 02 Mar 2016 11:58:46 +0530 Piramal Enterprises Consumer Products division recently announced the launch of India's first ever Benzocaine based throat spray - 'Throatsil', a sore throat pain relief product. It is currently launched in two markets of Southern India namely-Chennai and Coimbatore. Throatsil comes in a unique spray format which helps reach back of the throat. It has a 3 in 1 Action that gives relief from throat pain, fights throat infection and soothes cough. The product contains Amylmetacresol BP & 2 and 4-dichlorobenzyl alcohol which helps reduce infection in the throat and Benzocaine which is like a local anesthetic commonly used as a topical pain reliever or in cough drops. Mr Kedar Rajadnye - president and chief operating officer, Consumer Products Division, Piramal Enterprises said, "We have always believed that the consumer is empowered to take his/her own decision. Our products in the OTC category essentially target the problem solving space and help the consumer solve problems that disrupts their day-to-day lives. Our recent launch - Throatsil caters to the unmet need for sore throat relief in the self-care space. Environmental changes, pollution and contamination of air have led to frequent throat infections. Throatsil will help consumers achieve quick recovery and return to their regular lifestyle." Increasing levels of air pollution and spread of infections in an urban lifestyle are known to be some of the main reasons for various respiratory infections. Exposure to particulate matter can cause sore throat pain, which causes irritation, and can cause mild discomfort to severe pain in throat. The National Ambient Air Quality Standard for PM10 for residential, industrial and rural areas is 55 ug/m3. However, the same level for Chennai and Coimbatore was found to be higher, at 67. 72 ug/m3. This study and research has led to the test launch of Throatsil in these cities. "Our study and research shows that Tamil Nadu is second largest state in India affected with throat infections. Hence, we have chosen two cities in the state - Chennai and Coimbatore to conduct our test launch," added Mr Kedar. Throatsil is available at an Rs 149 for 45ml in menthol flavour. ]]> <![CDATA[Aurobindo Pharma wins FDA approval for new generic ]]> https://biospectrumindia.com/news/95/7376/aurobindo-pharma-wins-fda-approval-for-new-generic-.html https://biospectrumindia.com/news/95/7376/aurobindo-pharma-wins-fda-approval-for-new-generic-.html Wed, 02 Mar 2016 11:58:29 +0530 Aurobindo Pharma has received final approval from the US Food and Drug Administration (USFDA) to manufacture and market Acetylcysteine Injection, 6g/30 mL (200 mg/mL) single-dose vials. The product is expected to be launched in Q1 FY16-17. The approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) Acetadote Injection, 6 g/30 mL, of Cumberland Pharmaceuticals. Acetylcysteine Injection is an antidote for acetaminophen (non-aspirin pain reliever or analgesic) overdose indicated to prevent or lessen hepatic injury after ingestion of a potentially hepatotoxic quantity of acetaminophen. The approved product has an estimated market size of $28 million for the twelve months ending December 2015 according to IMS. ]]> <![CDATA[Jharkhand initiates collaborative action to address noncommunicable diseases]]> https://biospectrumindia.com/news/95/8085/jharkhand-initiates-collaborative-action-to-address-noncommunicable-diseases.html https://biospectrumindia.com/news/95/8085/jharkhand-initiates-collaborative-action-to-address-noncommunicable-diseases.html Tue, 01 Mar 2016 12:04:00 +0530 Jharkhand's political leaders, senior government officials, leaders in the field of Noncommunicable Diseases came together to launch the UDAAN (United Dialogue and Action Against Noncommunicable Disorders), an initiative aimed at reducing the burden of three of the most common noncommunicable diseases (NCDs) - diabetes, hypertension and cardiovascular disease. In implementing the new, UDAAN program, the partners will work collaboratively with the government of Jharkhand and local civil society organizations to more effectively implement the National Program for Prevention and Control of Cancer, Diabetes, Cardiovascular Disease and Stroke (NPCDCS) guidelines, which were established by the government of India to combat the growing burden of NCDs. At the Project UDAAN launch event representatives from the Ministry of Health and Family Welfare, members of the legislative assembly, members of parliament, civil society organization, doctors and corporate leaders were present. The event was presided over by Shri Raghubar Das, honorable Chief Minister of Jharkhand, , where he appreciated the public private partnership in the form of UDAAN, indicated it's the wakeup call for people of Jharkhand to join hands and fight against growing incidence of Diabetes, HBP and CVDs. He extended his best wishes and heartfelt support for UDAAN initiatives. Shri Ramchandra Chandravanshi, Health Minister, Jharkhand highlighted, "Jharkhand invites the participation of, Project HOPE, Boston Scientific and Vikas Bharti to work with the government in providing technical assistance to strengthen health systems, help mobilize communities and extended his support for implementation of UDAAN." Shri Prabal Chakraborty, vice president and managing director, Boston Scientific said, "Boston Scientific is honoured to partner with Project HOPE and the government of Jharkhand to roll out Project UDAAN in Ranchi District. These initiatives to train, educate and strengthen the healthcare networks in the district will have a lasting and sustainable impact on the health of the residents of Ranchi. We believe that it is through public-private partnerships such as this that will extend the reach of quality healthcare to all neighborhoods and transform the lives of patients and people everywhere." The new UDAAN program embodies Project HOPE's mission and philosophy of helping people to help themselves. Through this public private partnership, we aspire to create a movement for tackling NCDs that involves all professionals, academia, corporate sector, international partners, and civil society to strengthen both community and the health systems", said Ms Linda Heitzman, executive vice president, Project HOPE. "We have the political will and the technical skill to combat NCDs. Now we need to bring all the needed inputs, resources and actions from public and private sector together to prevent and manage NCDs", said Dr Laxmikant Palo, regional director, Project HOPE. "India's greatest national treasure is our people. We cannot afford to neglect their well-being and allow so many of our citizens to face consequences NCDs. We commit full support from Vikas Bharti to mobilize communities and implement this noble initiative for NCDs," said Shri Ashok Bhagat, chief functionary and secretary Vikas Bharti. Some key activities of the program will include:1) Promote communications, social and behavioral change through interpersonal communication and community mobilization, 2) Enhance systems and capacity for treatment and management of complications at NCD clinics (only referral to tertiary care), 3) Link to state health insurance schemes, 4) Create an enabling environment for improved partnership, 5) Expand learning for planning, management and scaling NCD interventions 6) Conduct evidence-based advocacy for improved NCD services and coverage. ]]> <![CDATA[How the Industry sees the Union Budget 2016?]]> https://biospectrumindia.com/news/95/8277/how-the-industry-sees-the-union-budget-2016.html https://biospectrumindia.com/news/95/8277/how-the-industry-sees-the-union-budget-2016.html Tue, 01 Mar 2016 11:16:10 +0530 Mr Satish Reddy, chairman, Dr Reddy's Laboratories on Union Budget 2016: "Budget 2016 has been a mixed bag overall. The focus on infrastructure, rural development and social sector spending are important catalysts for boosting the economy's growth rate. On the healthcare front, the budgetary emphasis on the sector was fairly muted. While certain initiatives such as the new health insurance scheme or the National Dialysis Services program are good, perhaps a more holistic, well rounded thrust would have served the sector better in delivering good health to those in need of it. The initial outlay of 1,000 crores to fund higher education is simply not enough, given the huge gap and growing need for students to have access to high quality education. One hopes that the government will build upon this and expand access to higher education to a much larger section of society. The plan to set up the National Board of Skill Development in partnership with industry and academia is definitely a step in the right direction. This move will foster an environment of understanding and collaboration that will ensure skill development is mapped to industry needs, thereby creating more job opportunities in the long run. The finance minister began his speech by articulating the 9 pillars on which his budget proposals were built, that would have a transformative impact on the economy and people. The social sector, including healthcare was in the top 5. We now look forward to a positive impact on this important aspect of India's growth story." Mr Gautam Khanna, CEO - P. D. Hinduja Hospital and Medical Research Centre Union Budget 2016: "Social sector with healthcare" is one of the 9 pillars of the Union Budget 2016-17. This year's budget has focused at few specific schemes like the National Dialysis Program and the Pradhan Mantri Jan Aushadhi Yojana. 2.2 lakh renal patients are added every year in India and the distribution of health facilities in the country is skewed. The proposed National Dialysis Program would make treatment more accessible. Likewise, 3,000 medical stores will be opened under Pradhan Mantri Jan Aushadhi Yojana to make quality medicine available.But it is important that these schemes are executed and monitored such that the maximum benefit reaches to the patients who need them the most. This year's budget once again left out key areas like overall healthcare spending, National Health Mission, Universal Health Coverage, health infrastructure and primary and secondary healthcare. The new health insurance schemes are a step to make healthcare affordable to the vulnerable sections. Rs. 1804 cr. have been allocated for skill development. We await the details if there are plans to boost skill development in the healthcare sector (trained medical technicians etc.). Another area of concern is the reduction of benefits of deductions for research from 150 to 100 percent from 1st April 2020. This may impact the funding for medical research. Overall, the Union Budget 2016-17 could have done more in terms of greater public spending in healthcare to strengthen public healthcare and build infrastructure and manpower capacity to bridge the current gaps in the sector." Mr Rajiv Nath, forum coordinator AIMED and joint managing director, Hindustan Syringes and Medical Devices(HMD)on Budget 2016: "Finance Minister Shri Arun Jaitley must be applauded for bringing budget's focus on rural community as well as senior citizens. Budget's proposal to set up 3,000 medicine shops in rural areas and announcement of insurance scheme for senior citizens is noteworthy. But then, given India's humungous population with majority of people having very modest income, the biggest challenge that our country faces is to ensure low cost quality healthcare access for majority of citizens.Government needs to realize that medicines are just one component of healthcare cost and very often not its major component! Medical devices can be equally if not more as critical a part of overall healthcare cost as medicines and diagnostics. If the government had focused on giving a major boost to medical device manufacturing in the country and also ensured a robust MRP regime, then it would have served many purpose with one shot - i.e. (a) Lower the overall healthcare cost and (b) lead to sharp reduction on import dependency and growth in exports. The additional critical benefit would have been quality job creation within the country. Anyway, we are still awaiting the fine print and we are just hoping that some of our pre-budget recommendations have been incorporated. These include: (a) Withdrawal of Concessional Duty Notification of Basic Duty and Special Additional Duty of Medical Devices and for reverting of Duty on the items covered under HS 90.27, 30.06 and 38.22 ( mainly diagnostics - equipments & reagents) (b) Imposition of 10 percent Basic Duty on HS 90.27 & HS 30.06 (C) reduction in duty of raw materials to 2.5 percent to produce above devices and diagnostics .In addition, we also need to think of consumers and dept should consider to introduce an Tax Innovation Structure of stalling Artificial Inflation of MRP by imposing a 2 percent CVD on MRP based criteria with Abatement of at least 50 percent (in case 1 percent Excise Duty on MRP is not possible) to have a disincentive to importers from passing on above increase to the Consumers. This will make Indian Medical Devices including Diagnostics competitive and safeguard consumers from exploitation." ]]> <![CDATA[Bangalore runs to raise voice of rare disease patients]]> https://biospectrumindia.com/news/95/3870/bangalore-runs-to-raise-voice-of-rare-disease-patients.html https://biospectrumindia.com/news/95/3870/bangalore-runs-to-raise-voice-of-rare-disease-patients.html Mon, 29 Feb 2016 16:57:36 +0530 The objective was to raise awareness for the 70 million estimated patients in India suffering from a rare disease. The 7km event was flagged off by South Indian Cine Star Mr Kishore Kumar G, Mr Rajeev Gowda, Member of Parliament, and Mr Naz Haji, Quintiles India Head at St. Joseph's Indian High School. Running and walking through Cubbon Park amidst a highly charged atmosphere, the event saw over 50 patients with rare diseases participate, some coming from as far away as Mumbai and Delhi. This included Mr Nihal Bitla, a patient suffering from Progeria (the medical condition which featured in the Hindi movie Paa) who travelled all the way from Mumbai to extend his support to the cause of rare diseases. Speaking on the occasion, Kannada Cine Star, Mr Kishore Kumar G, said, "I am humbled to be part of this noble initiative which champions the rights of people living with rare disease. It's time we all get together, create awareness and extend our support in initiating change that will help improve the lives of patients living with rare diseases. You and I can make a difference!" The post event entertainment witnessed performances from some of the patients present for the event. Ms Nidhi Shirol, a patient suffering from Pompe Disease, and Mr Jayanth Gowda, a patient suffering from MPS Type4, had the audience singing along and dancing to their song performances. Mr Prasanna Kumar B Shirol, Founder Director, ORDI and the father of Ms Nidhi Shirol, "I am glad to see an overwhelming response to the first Race for 7. Today is a historic moment for us as it is for the first time in India we have seen so many people come together to create awareness for rare diseases. This support from each one of you has given us a voice which we hope reaches the policy makers. We require everyone's support to convert this hope into a resultant 'Rare Disease Policy'." The participants were in high spirits and were seen shaking their legs enthusiastically to the music and Zumba performances by Quintiles employees, the primary sponsors of Race for 7. "When we talk about rare diseases, it's all in terms of statistics...7000 rare disease, 700 million patients in India, an average of 7 years to diagnose, 50% of those affected are children...and so on," said Mr Naz Haji, Quintiles India Head."Behind all these statistics are real people...many born like you and me but who go through the rest of their lives challenged not just by their disabilities but by the lack of knowledge and awareness that exists abut rare diseases. That is why Race for 7 assumes so much importance. It is a platform to build awareness so that a strong ecosystem of various stakeholders can come together to help patients and their caregivers live their lives with hope and dignity so that rare diseases are no longer a statistic." ORDI was founded to address the many challenges in the management of rare disease in India. It aims to address the unmet needs of rare disease patients in India and serves as an umbrella organization for rare disease patients and other stakeholders throughout the country. The funds raised from Race for 7 will be utilized to help ORDI in its mission to improve health of patients with rare diseases across India through awareness, advocacy, collaborations and information dissemination. Mr Jayant Gowda, a youngster suffering from MPS, Type 4 disorder said, "Thank you everyone for coming here and supporting us in creating awareness. We hope all this translates into fruitful results and next year we meet again to celebrate and not just to create awareness." Ms Dhanya, a patient suffering from Osteogenesis Imperfecta (a brittle bone disorder), said, "On behalf of all rare disease patients, we would like to thank each and every one for being a part of this event. We are greatly pleased with the response we have received and take pride in the fact that people have extended their support in improving and amplifying the voices of rare disease patients." ]]> <![CDATA[NOACs to recover from slow initial uptake ]]> https://biospectrumindia.com/features/95/6667/noacs-to-recover-from-slow-initial-uptake-.html https://biospectrumindia.com/features/95/6667/noacs-to-recover-from-slow-initial-uptake-.html Mon, 29 Feb 2016 16:56:13 +0530 The use of novel oral anticoagulants (NOACs) will see a substantial rise in the anticoagulation market space after an initially sluggish uptake, and will start to be elected over warfarin, the current standard-of-care product in certain indications, according to an analyst with research and consulting firm GlobalData. Dr Lakshmi Dharmarajan, GlobalData's Senior Analyst covering Cardiovascular and Metabolic Disorders, states that: "NOACs are increasingly being used in patients with venous thromboembolism (VTE) due to the drugs' rapid onset of action and the ability to be administered in fixed doses without the need for regular coagulation monitoring. "Among the VTE population, the fastest to adopt NOACs have been the orthopedic patient segments, for the prevention of deep vein thrombosis (DVT)." For those with DVT, Xarelto has been demonstrated by real-world studies to have economic advantages over standard-of-care treatments. As Dr Dharmarajan explains: "Positive evidence such as shorter hospital stays, in addition to the obvious clinical benefits of these drugs, will encourage payers and healthcare systems to recognize their financial advantages over existing treatments. "For the anticoagulation market in general, a concerted effort by NOAC manufacturers to provide clinical practice evidence is absolutely essential for these drugs to challenge the 65-year legacy built by warfarin." Fortunately for such manufacturers, the launch of reversal agents will help boost NOAC usage in the near future. Even in cost-conscious markets such as the UK, physicians envision a dramatic shift towards NOACs, at least for the majority of the VTE population. "For NOAC developers, the next step should be to evaluate the efficacy and safety of the drugs for patients with VTE and cancer, and also for the prophylaxis of VTE. This would enable the treatment to achieve universal acceptance in the VTE population as the standard-of-care therapy," the analyst concludes. ]]> <![CDATA[Industry react on Budget 2016]]> https://biospectrumindia.com/news/95/3569/industry-react-on-budget-2016.html https://biospectrumindia.com/news/95/3569/industry-react-on-budget-2016.html Mon, 29 Feb 2016 15:40:00 +0530 Healthcare sector neglected Again: Mr Vishal Bali, co-founder and chairman, Medwell Ventures"Budget 2016 once again neglects the overall development of the healthcare sector. For a sector that has an intense demand supply gap, the finance minister has given it a cursory attention. There is no fundamental change to increase public healthcare spending and give it the necessary boost towards 2 percent of GDP. The budget is also silent on Universal Healthcare coverage agenda which has been often discussed by the Govt. Healthcare should have been an integral part of the focus that has been given to infrastructure. The decision to provide health insurance coverage of 1lac to senior citizens of BPL families is a good move besides the step to launch a National Dialysis services program under PPP structure. The NCD epidemic in India has not been given any attention towards increased allocation. The announcement of tax holiday for startups for three of five years of setting up the company might encourage innovative healthcare firms to set up their business to usher in the much change that is likely to make healthcare sector more technology-driven. Holding fiscal deficit at 3.5 percent of the GDP is a good but healthcare given the miss as a national agenda." Post budget reaction on the Union Budget 2016 by Mr Richard van der Merwe, vice chairman and managing director and CEO of Bayer CropScience. "The Union Budget has set the direction for a balanced growth, emphasizing on increasing agricultural productivity and reducing rural distress through a host of social reforms. The Finance Minister's proposal to focus on agriculture and farmers' welfare and allocation of over Rs. 5000 crore towards crop insurance scheme, direct benefit transfers for fertilizers, enhanced irrigation acreage and agri credit targets to the tune of Rs. 9 lakh crore is a very welcome move. The outlay towards development of roads and national highways will help in the movement of perishable goods, alleviating wastage of produce and maximizing returns for farmers on one hand and driving accessibility and price parity across the country for end consumers on the other. All in all the finance minister has tried his level best to bring back focus to the core sectors with his nine pillars agenda." Comments of Mr Hari Bhartia, co-chairman and managing director, Jubilant Life Sciences, on Central Budget Commenting on the Budget presented by the Finance Minister, Mr Hari S Bhartia, co-chairman and managing director, Jubilant Life Sciences said that overall it is a very balanced Budget and would give a boost to growth sentiments and revive domestic economy. The Finance Minister has kept the fiscal discipline by keeping the budget deficit to 3.5 percent in 2016-17. This will give greater confidence to investors, both in India and overseas. The Finance Minister has taken the reform process forward with emphasis on nine pillars. Mr Bhartia particularly welcomed the focus on agriculture, rural economy, social and infrastructure sectors. The focus on rural economy will generate demand, increase consumption and create opportunities for the corporate sector. "This is a Budget with spirit of T-20 & philosophy of a Test Match" said Mr Bhartia," since the Finance Minister has addressed both short and long term issues facing the economy." Post-budget reaction on healthcare sector by Mr Shrikant Soman, CEO, Bhatia Hospital. "This year's Union Budget 2016-17 has completely varied reaction for the healthcare sector. Though the new initiatives which were announced are good but not enough to meet the current challenges that our industry is facing. The new health protection scheme announced will provide health cover of up to Rs 1,00,000 per family with an additional top up of Rs 30,000 for senior citizens of 60 years and above. This will provide some relief from financial stress caused due to serious illness of family members to poor and economically weak families. With opening of 3000 stores under Prime Minister's Jan Aushadhi Yojana in 2016-17 is a welcome move towards making quality drugs readily available at an affordable prices. Starting a 'National Dialysis Service Program' through PPP model and exempting tax from dialysis equipment will provide an access to a huge number of patients of End Stage Renal Disease in India every year. However there was no significant take away from the budget apart from the above initiatives. The budget ignored revision of service tax in healthcare sector as we as it didn't relook at the healthcare infrastructure fund which would have encourage healthcare entrepreneurship." ]]> <![CDATA[Budget 2016 focus on agriculture and farmers' welfare ]]> https://biospectrumindia.com/news/95/6882/budget-2016-focus-on-agriculture-and-farmers-welfare-.html https://biospectrumindia.com/news/95/6882/budget-2016-focus-on-agriculture-and-farmers-welfare-.html Mon, 29 Feb 2016 14:58:38 +0530 Major focus on agriculture and farmers' welfare, a new health protection scheme etc are major highlights of the General Budget 2016-17 presented in Lok Sabha today by Union Finance Minister Shri Arun Jaitley The Finance Minister said the agenda for the next year will be to 'Transform India' in this direction. He highlighted that the budget proposals are built on this transformative agenda with nine distinct pillars which include: Agriculture and Farmers' Welfare; Rural Sector; Social Sector including Healthcare; Education, Skills and Job Creation; Infrastructure and Investment; Financial Sector Reforms; Governance and Ease of Doing Business; Fiscal Discipline and Tax Reforms. Mr Jaitley announced that the Government will reorient its interventions in the farm and non-farm sectors to double the income of the farmers by 2022. He said total allocation for Agriculture and farmers' Welfare is Rs 35,984 crore. Stating that the 'Pradhan Mantri Krishi Sinchai Yojana' has been strengthened and will be implemented in mission mode, he said 28.5 lakh hectares will be brought under irrigation under this Scheme. He also underlined that the implementation of 89 irrigation projects under AIBP, which have been languishing will be fast tracked. The Finance Minister announced creation of a dedicated Long Term Irrigation Fund in NABARD with an initial corpus of about Rs 20,000 crore. To achieve all these, a total provision of Rs 12,517 crore has been made through budgetary support and market borrowings in 2016-17. He also said, simultaneously a major programme for sustainable management of ground water resources has been prepared with an estimated cost of Rs 6,000 crore and proposed for multilateral funding. The Minister said at least 5 lakh farm ponds and dug wells in rain fed areas and 10 lakh compost pits for production of organic manure will be taken up by making use of allocations under MGNREGA. Mr Jaitley said the Soil Health Card Scheme will cover all 14 crore farm holdings by March 2017. He said 2,000 model retail outlets of fertilizer companies will be provided with soil and seed testing facilities during the next three years. The Finance Minister announced that the allocation under Pradhan Mantri Gram Sadak Yojana has been increased to Rs 19,000 crore and it will connect remaining 65,000 eligible habitations by 2019. In the budget special focus has been given to ensure adequate and timely flow of credit to the farmers. Against the target of Rs 8.5 lakh crore in 2015-16, the target for agricultural credit in 2016-17 will be an all-time high of Rs 9 lakh crore. To reduce the burden of loan repayment on farmers, a provision of Rs 15,000 crore has been made in the BE 2016-17 towards interest subvention. The Finance Minister informed that for effective implementation of Prime Minister Fasal Bima Yojana, Rs 5,500 crore have been provided in the Budget 2016-17. He said to make dairying more remunerative to the farmers, four new projects will be taken up: First the 'Pashudhan Sanjivani', an animal wellness programme and provision of Animal Health Cards ('Nakul Swasthya Patra'); Second , an Advanced breeding technology; Third, Creation of 'E-Pashudhan Haat', an e market portal for connecting breeders and farmers; and Fourth, a National Genomic Centre for indigenous breeds. These projects will be implemented at a cost of Rs 850 crores over the next few years. Mr Jaitley also announced a new health protection scheme which will provide health cover up to Rs One lakh per family for economically weak families. For senior citizens of age 60 years and above belonging to this category, an additional top-up package up to Rs 30,000 will be provided. In order to make quality medicines available at affordable prices, 3000 stores under Prime Minister's Jan Aushadhi Yojana will be opened during 2016-17. He said that a 'National Dialysis Services Programme' will be started to provide dialysis services in all district hospitals. ]]> <![CDATA['1 in 20 Indians suffers from a Rare Disease']]> https://biospectrumindia.com/news/95/6269/1-in-20-indians-suffers-from-a-rare-disease.html https://biospectrumindia.com/news/95/6269/1-in-20-indians-suffers-from-a-rare-disease.html Mon, 29 Feb 2016 12:48:36 +0530 There are close to 7000 known rare diseases today, most of which are progressive, life-threatening and chronically debilitating conditions. There is no treatment for more than 90 percent of these diseases and the number of patients with rare diseases continues to increase every year. The vast majority of rare diseases are genetically inherited and exist over the lifetime of a patient. Approximately 50 percent of those affected by rare diseases are children, of whom around 30 percent will not live to see their fifth birthday. On an average, it takes around seven years to diagnose a rare disease. In India alone, there are an estimated 70 million patients living with a rare disease, many of whom do not know they have a rare disease and even when they do, they either have no access to treatment or cannot afford it. These statistics alone highlight the compelling need for more clinical research in rare diseases in India. "It is ironic that rare diseases are no longer a rare occurrence. Although we have made tremendous progress in science and medicine, very little has been invested in India in understanding rare diseases and their management," said Ms Suneela Thatte, president, ISCR. "We need a more concerted effort to promote clinical research in India to find newer, affordable and effective therapies for the 70+ million patients in India who suffer from a rare disease who have an equal right to benefit from new medicines and treatment available to patients in other parts of the world." Every year, the last day of February is observed as Rare Disease Day to raise awareness about rare diseases. The theme this year is "Patient Voice", which recognizes the crucial role that patients play in voicing their needs and in instigating change that improves their lives and the lives of their families and caregivers. "Our children have a right to live with dignity and in an environment where there are investments being made in clinical research that could help them lead a better quality of life. We seek the support of the media in highlighting the cause of rare diseases in India and the challenges of patients living with illnesses for which there is no known cure," said Mr Samir Sethi, president, Indian Rett Syndrome Foundation and parent of a daughter diagnosed with Rett Syndrome. "Awareness, accessibility and affordability are key needs of patients suffering from rare disease and early diagnosis is a critical challenge in the management of rare diseases," said Mr Prasanna Shirol, founder member, Organisation for Rare Disease India (ORDI) whose daughter suffers from a rare disease. "The cost of treatment for rare disorders is very high and a lifelong expense running into tens of lakhs of rupees each year. Most patients and their families find this an enormous economic burden. There exists an urgent need for clinical research to ensure better and more affordable medicines for rare diseases so we can provide sustainable care to patients. From a policy perspective, we need legislation that specifically targets budgetary support, access, innovation, and investment for rare disease treatment in India." ]]> <![CDATA[ Parkinson's market to hit $3.2 bn by 2021 as search for cure continues]]> https://biospectrumindia.com/features/95/8276/-parkinsons-market-to-hit-3-2-bn-by-2021-as-search-for-cure-continues.html https://biospectrumindia.com/features/95/8276/-parkinsons-market-to-hit-3-2-bn-by-2021-as-search-for-cure-continues.html Fri, 26 Feb 2016 13:55:54 +0530 While the Parkinson's disease market is set to expand from $2.1 billion in 2014 to $3.2 billion by 2021, at a moderate Compound Annual Growth Rate (CAGR) of 5.7%, game-changing treatments will not be available for the foreseeable future, according to business intelligence provider GBI Research. The company's latest report states that Parkinson's disease market growth will occur despite the patent expiries of several key products during the forecast period. These treatments include Azilect, Neupro, and Stalevo. Ms Parnjeet Bains, Analyst for GBI Research, says: "New entrants are expected to offset the inevitable generic erosion caused by patent expiries, as drug developers focus their attention on offering easier methods of administration and continuous symptomatic relief. "For example, four new levodopa formulations are expected to enter the market by 2021, each designed to improve off-episodes in advanced Parkinson's disease patients by providing continuous drug administration." However, despite steady market growth, various unmet needs remain and a cure is yet to be found. As with Alzheimer's disease, a viable therapeutic target to halt or slow disease progression is currently not in scope due to the fact that underlying mechanisms that cause Parkinson's disease are not fully understood. Bains explains: "Most pipeline drug development programs are in their early stages, with the majority in the Preclinical stage. This means that game-changing products are far from being realized, and explains why symptom-relieving therapies will continue to dominate the market through to 2021." In order to combat the vast array of unmet needs in the Parkinson's disease treatment space, developers are concentrating on disease modification as opposed to mere symptom relief. "Despite the short-term forecast for Parkinson's disease patients, the current pipeline is very active, consisting of 365 products and a diverse range of molecular targets. It includes a wide range of innovative approaches, including gene therapies and neuroprotective and neuroregenerative agents, suggesting that more effective drugs may be on the horizon," the analyst concludes. ]]> <![CDATA[China to account nearly half of Hep B drug sales in major markets by 2024]]> https://biospectrumindia.com/features/95/6664/china-to-account-nearly-half-of-hep-b-drug-sales-in-major-markets-by-2024.html https://biospectrumindia.com/features/95/6664/china-to-account-nearly-half-of-hep-b-drug-sales-in-major-markets-by-2024.html Thu, 25 Feb 2016 14:12:56 +0530 China will remain the largest major hepatitis B market over the next decade, rising from just under $923 million in 2014 to over $1.4 billion by 2024, representing a Compound Annual Growth Rate (CAGR) of 4.4%, according to research and consulting firm GlobalData. The company's report, which covers the eight major markets (8MM) of the US, France, Germany, Italy, Spain, the UK, Japan and China, states that China will continue to dominate the hepatitis B treatment space, as its market share rises from 38.8% in 2014 to 47.2% by 2024. Dr Daian Cheng, GlobalData's Analyst covering Infectious Disease, says this hepatitis B market trend will be largely down to natural population growth and China's huge and increasing drug-treated population, which currently makes up 80% of treated cases across the 8MM. Dr Cheng adds: "China's proportion of treated cases is much higher than its market share because hepatitis B therapeutics cost much less compared with other regions. Indeed, it is the sheer increase in the number of drug-treated patients that will drive market growth. "The projected increase of patients alone, nearly 300,000 between 2014 and 2024, is much more than the total number of treated patients in the US, which is around 100,000. Thus, the increase in therapeutic sales will be considerable and China will hang on to its market dominance, even with lower drug prices." Despite the relatively high rates of hepatitis B among the Chinese population, infants are screened for the infection as part of health checks at birth, and at various points throughout their lives, a practice which is mostly organized by schools and employers. Dr Cheng explains: "There are clear efforts being made in China to improve screening and public awareness. However, GlobalData anticipates that poorer citizens will have limited access to drugs and information over the forecast period, which will be a barrier to market growth and perpetuate the country's hepatitis B problem." ]]> <![CDATA[Game-Changing drugs from Merck Serono and TissueGene to transform future osteoarthritis market]]> https://biospectrumindia.com/features/95/8136/game-changing-drugs-from-merck-serono-and-tissuegene-to-transform-future-osteoarthritis-market.html https://biospectrumindia.com/features/95/8136/game-changing-drugs-from-merck-serono-and-tissuegene-to-transform-future-osteoarthritis-market.html Thu, 25 Feb 2016 14:11:48 +0530 The osteoarthritis space will experience seismic changes over the next decade, as disease-modifying drugs are expected to launch for the first time into a market currently dominated by a host of generic pain-relieving treatments, according to an analyst with research and consulting firm GlobalData. The late-stage development pipeline currently comprises two such drugs, namely TissueGene's Invossa and Merck Serono's sprifermin, which are expected to launch in the US in 2020 and 2021, respectively. Both drugs have shown evidence of slowing disease progression, and Invossa was also found to reduce osteoarthritis pain in trials. Dr Lu Chen, GlobalData's Analyst covering Immunology, explains: "Without disease-modifying modalities that slow or reverse the disease progression, many osteoarthritis patients eventually require joint replacement surgeries and may become disabled. Thus, the need for disease-modifying drugs for osteoarthritis is immense, particularly considering that the condition is a leading cause of disability in developed countries. "Despite this need, osteoarthritis can appear to be static for a long time and mild cases are largely managed by inexpensive generic drugs. In this way, therapies such as Invossa and sprifermin may experience slow adoption and be limited to use in more severe cases initially." Following sluggish initial uptake, assuming that disease-modifying drugs overcome reimbursement barriers and fully establish their cost-effectiveness, GlobalData anticipates broader use of these therapeutics in the long term. Dr Chen continues: "Both Invossa and sprifermin hold the potential to drastically change the osteoarthritis disease treatment paradigm and market. "Sprifermin is likely to cost less than Invossa, and therefore experience better uptake initially. However, as Invossa is more expensive, and has the added benefit of lowering pain as well as slowing joint deterioration, it will likely achieve US sales of over $560 million in 2024, compared with around $310 million for sprifermin." ]]> <![CDATA[Bayer AG announces new chairman]]> https://biospectrumindia.com/news/95/6136/bayer-ag-announces-new-chairman.html https://biospectrumindia.com/news/95/6136/bayer-ag-announces-new-chairman.html Thu, 25 Feb 2016 11:07:58 +0530 Effective May 1, 2016, Mr Werner Baumann will become the new Chairman of the Board of Management of Bayer AG. This was decided by the company's Supervisory Board at its meeting. The current CEO of Bayer AG, Dr Marijn Dekkers, proposed to the Supervisory Board that his contract be dissolved effective April 30, 2016, following the Annual Stockholders' Meeting. The Supervisory Board approved this proposal. Dr Marijn Dekkers has been Chairman of the Board of Management of Bayer AG since October 1, 2010. "With its clear focus on the Life Science businesses and its new organizational structure, Bayer is in a position of strength. The course for successful future development has already been set at all levels. Also with a successor from within the company there will be no need for a familiarization period. I would like to wish Werner Baumann every success in his new role," said Dr Dekkers, whose contract was originally set to run until December 31, 2016. At the present time, Baumann is the Board member with responsibility for Strategy and Portfolio Management. He will retain these functions in the future. Going forward, the Board of Management of Bayer AG will comprise seven members instead of eight. Mr Oliver ZÃ¼hlke, chairman of the Bayer central works council and vice chairman of the supervisory board, emphasized that Bayer's decision represents continuity for the company. "We have been closely involved in the changes of recent years. We would like to thank Dr Dekkers for always being open to the concerns raised by the employee representatives. In Werner Baumann, Bayer has chosen a manager who is intimately familiar with the company. On behalf of the entire workforce, we would like to wish him every success in his new role. We will do all we can to support him." Mr Werner Baumann was born in Krefeld, Germany, on October 6, 1962. After studying economics at RWTH Aachen University and the University of Cologne, he joined Bayer in 1988. His first duties were in the Corporate Finance Department in Leverkusen. In 1991 he transferred to Bayer Hispania commercial in Barcelona, Spain, to take up a position as controller, becoming assistant to the managing director in 1995. One year later, he moved to Bayer Corporation in Tarrytown, New York, latterly heading up the global Business Planning & Administration organization of the Diagnostics Business Group. In July 2002, Baumann returned to Germany to become a member of the Executive Committee and Head of Central Administration & Organization at Bayer HealthCare. In October 2003, he was appointed a member of the Board of Management of the newly formed subgroup Bayer HealthCare AG, also serving as the company's Labor Director. As a member of the Board of Management and Labor Director of Bayer Schering Pharma AG, Berlin, Germany, from 2006 through September 2009, his roles included actively participating in this company's integration into the subgroup. Mr Werner Baumann has been a member of the Board of Management of Bayer AG since January 1, 2010. Prior to September 30, 2014, he served as Bayer AG's Chief Financial Officer (CFO). Effective October 1, 2014, he was appointed Chief Strategy and Portfolio Officer (CSPO) with responsibility for Corporate Development and Mergers & Acquisitions. He is also responsible for the Europe region. Between April 1 and December 31, 2015, Baumann was additionally Chairman of the Board of Management of Bayer HealthCare AG. Werner Baumann is married and has four children. ]]> <![CDATA[Smart Financing key to sustainable growth of the healthcare sector: SFS study]]> https://biospectrumindia.com/news/95/3471/smart-financing-key-to-sustainable-growth-of-the-healthcare-sector-sfs-study.html https://biospectrumindia.com/news/95/3471/smart-financing-key-to-sustainable-growth-of-the-healthcare-sector-sfs-study.html Wed, 24 Feb 2016 11:31:13 +0530 Siemens Financial Services (SFS) commissioned and released a new research report on 'Smart Financing in the Healthcare sector' and reveals how it is set to be a game-changer for Healthcare and related industries. The qualitative research was conducted with healthcare providers across 13 countries which revealed that organizations are facing four common pressures: demographic change; shifting patient expectations; requirement to reform and the rising tide of healthcare technology trends. Digitalization and Smart Financing have been recognised as the ultimate remedy for the increasing pressures in healthcare. Over half of healthcare CFOs surveyed are already using a range of financing techniques, among which asset finance is the most popular. The study highlights that healthcare professionals regard new-generation technology as critical in enabling their organizations to transform. Moreover, more than half of the CFOs interviewed said investment in new-generation technology is 'an urgent priority'. Digitalization and automation are seen as vital cogs to enable the transition, particularly with the move to early detection, value-based reimbursement models and population health management. In this respect, respondents cited three new-generation technology investment priorities: imaging and diagnostics; IT and electronic patient records management; surgery and surgical automation. The research reveals that smart finance - such as leasing and renting-based packages - is seen as critical to healthcare organizations' ability to manage the changing demands in workflow and also to avert crisis. Flexible financing techniques are becoming an increasingly important part of the healthcare CFO's financial toolkit, as healthcare organizations face global pressure to change despite the constraint of financial resources. "With the healthcare industry facing pressures due to demographic change; shifting patient expectations; requirement to reform and the rising tide of healthcare technology trends and digitalization CFOs of healthcare organizations are prioritizing where valuable funds are directed. Smart financing techniques are increasingly critical in enabling organizations to acquire the new-generation, digitalized technology that is so fundamental in managing pressures to change" said Mr Sunil Kapoor, CEO, Siemens Financial Services (India). Chief Financial Officers in healthcare organizations were interviewed by telephone in a qualitative research study between August and October 2015. The interviewees came from public and private healthcare institutions in the following countries: India, China, Finland, France, Germany, Norway, Poland, Russia, Spain, Sweden, Turkey, UK and USA. Respondents were asked to give their views on the pressures to change faced by their institutions (their nature and severity), the role played by new-generation technology (particularly, but not exclusively, digitalized technology) in enabling effective change, and the use of a range of financing techniques to enable that technology acquisition. ]]> <![CDATA[Dermozone develops 'dalethyne ' for wound healing]]> https://biospectrumindia.com/news/95/6995/dermozone-develops-dalethyne-for-wound-healing.html https://biospectrumindia.com/news/95/6995/dermozone-develops-dalethyne-for-wound-healing.html Wed, 24 Feb 2016 11:30:59 +0530 Dermozone announced that it has developed 'dalethyne', a revolutionary chemical molecule compound, proven as an antimicrobial agent against most of the bacteria, fungi and yeasts. Dermozone's best kept secret, 'dalethyne' will be the key ingredient in the company's MedCare range of wound healing herbal products soon to be launched in India. Dalethyne will be a life saver for thousands of patients especially those suffering from chronic skin ailments like Acne, Fungal Infections, Dry Skin, Insect Bites, Athlete's Foot, Eczema, Blisters, Carbuncles and more importantly diabetic wounds, ulcers and burns. Dermozone's 'MedCare' brand comprises of four products- WoundCare (wound and burn), VaginyCare (feminine usage), BabyCare (allergies, rashes etc) and MedCare Soap. Dermozone also has another brand- 'BodyCare' that caters to the cosmetics and beauty care market with a range of seventeen products. Mr KS Dharshan, chairman and CEO of Dermozone, said, "'dalethyne ' is a unique compound created when olive oil is subjected to changes through a process called Ozonation for which I hold the IP right. This unique product is what 'dalethyne 'carries, with an increased efficacy stimulating the function of enzymes associated with your skin. This fastens the regeneration period of your skin when applied on cuts or wounds, also cures many skin infections in no time. 'dalethyne 'is no doubt our best kept secret in the complete range of Dermozone products" Dermozone, with headquarters in Jakarta, Indonesia had recently announced its entry into the Indian market, by setting up an office in Bengaluru in the name of Indo- Dermozone Herbal. Dermozone also has operations in UK, USA, Japan, Russia, Seoul, China, Taiwan, Hong Kong, South Africa, Brazil, Argentina, Mexico, Chile, Australia and Dubai (Middle East). Mr Manjunatha KG, chief operation officer of Indo- Dermozone Herbal said,"Dermozone has spent many years in researching and in perfecting a balanced and safe to use chemical design of dalethyne. The company comprises of a team of highly qualified and competent people who have dedicated and spent a lifetime in making this innovative product. We are associated with many laboratories around the world which enables us to make sure that our dalethyne would do its purpose and function in helping maintain much healthier skin. We have done numerous tests on biological and chemical functioning of the product and we have confirmed and proved both theoretically and experimentally with stringent testing that we have produced the best dalethyne." Currently, Dermozone's MedCare product 'WoundCare' is under clinical trial at Apollo Hospitals, Chennai and expected to be completed by the second quarter of 2016. ]]> <![CDATA[Glenmark gains FDA approval for new generic]]> https://biospectrumindia.com/news/95/3115/glenmark-gains-fda-approval-for-new-generic.html https://biospectrumindia.com/news/95/3115/glenmark-gains-fda-approval-for-new-generic.html Wed, 24 Feb 2016 11:30:43 +0530 Glenmark Pharmaceuticals USA (Glenmark) has been granted final approval by the United States Food and Drug Administration (US FDA) for Norgestimate and Ethinyl Estradiol Tablets USP, 0.18 mg/0.025 mg, 0.215 mg/0.025 mg, and 0.25 mg/0.025 mg. Glenmark's drug is the generic version of Ortho Tri-Cyclen Lo Tablets of Janssen Pharmaceuticals. According to IMS Health sales data for the 12 month period ending December 2015, the Ortho Tri-Cyclen Lo Tablets market1 achieved annual sales of approximately $503.9 million. Glenmark's current portfolio consists of 107 products authorized for distribution in the US marketplace and 62 ANDA's pending approval with the FDA. ]]> <![CDATA[Sandoz buys Pfizer's biosimilar infliximab]]> https://biospectrumindia.com/news/95/8106/sandoz-buys-pfizers-biosimilar-infliximab.html https://biospectrumindia.com/news/95/8106/sandoz-buys-pfizers-biosimilar-infliximab.html Tue, 23 Feb 2016 12:31:02 +0530 Sandoz, a Novartis company and a global leader in biosimilars, has acquired from Pfizer the rights for the development and commercialization of PF-06438179 (biosimilar infliximab) in the 28 countries that form the European Economic Area (EEA). Infliximab is a tumor necrosis factor alpha (TNF-Î±) inhibitor used to treat a range of autoimmune diseases including rheumatoid arthritis (RA) and psoriasis. "Infliximab is one of the most important biologic therapy options for people living with severe autoimmune diseases such as rheumatoid arthritis" said Mr Richard Francis, division head and CEO Sandoz. "We intend to complete the development and registration of PF-06438179 and make it available to patients across Europe as part of our robust portfolio of immunology treatments." Under the terms of the deal, Sandoz plans to complete the clinical study program and submit the biosimilar infliximab to the European Medicines Agency (EMA) for regulatory approval and registration with the European Commission. Included in the program is a global phase III trial - REFLECTIONS (B537-02) investigating the safety and efficacy of PF-06438179 and infliximab in combination with methotrexate in subjects with active rheumatoid arthritis who have had an inadequate response to methotrexate. Sandoz acquired the rights to infliximab, following Pfizer's commitments to the European Commission in connection with the acquisition of Hospira, to divest the program. Sandoz plans to make 10 regulatory filings over a three year period (2015-2017) having already announced five, which include biosimilar etanercept filed with both the EMA and the US Food and Drug Administration. ]]> <![CDATA[First vaccinations against dengue commenced in the Philippines ]]> https://biospectrumindia.com/news/95/8047/first-vaccinations-against-dengue-commenced-in-the-philippines-.html https://biospectrumindia.com/news/95/8047/first-vaccinations-against-dengue-commenced-in-the-philippines-.html Tue, 23 Feb 2016 11:07:33 +0530 Sanofi Pasteur, the vaccines division of Sanofi, announced that vaccinations with Dengvaxia have commenced in the Philippines following official receipt of the first shipment of the vaccine earlier this month. Dengvaxia, a tetravalent dengue vaccine, was approved in the Philippines on 22 December 2015 for the prevention of disease caused by all four Dengue types in individuals from 9-45 years of age living in endemic areas. The vaccine is administered in three doses given over a one-year period. Asia bears 70 percent of dengue fever burden globally with an estimated 67 million people being sickened by the disease annually. In the Philippines alone, over 110,000 people on average get Dengue every year. Asian endemic countries spend an estimated 6.5 billion USD annually in both direct medical and indirect costs due to Dengue.3 "This is truly a great moment in the history of vaccinology," states Dr Guillaume Leroy, vice-president of Dengue Vaccine, Sanofi Pasteur. He added, "Dengvaxia's availability for administration by healthcare providers in the Philippines, to be followed closely by the initiation of a public sector immunization program in the country is a landmark event for global Dengue prevention and a great achievementfor the people of the Philippines." Medical Societies in the Philippines held a media event in Manila earlier this month to welcome receipt of the first shipment of Dengvaxia to the country. In attendance, Dr Rose Capeding, chief of the Research Institute for Tropical Medicine's department of microbiology, noted that the Philippines participated in all three phases of the clinical development of the vaccine and that healthcare providers there were delighted to be able to begin vaccinating against dengue, which continues to pose a major public health threat to the nation. Dengue is a growing public health threat in tropical and subtropical countries in Asia and Latin America. Mainly an urban disease found in over 120 countries where half the world's population live, Dengue typically hits in the form of unpredictable outbreaks capable of paralyzing health care systems and disrupting social and economic activity in these city centers. Sanofi Pasteur is introducing Dengvaxia first in endemic countries like the Philippines where the vaccine has the greatest potential to reduce dengue burden globally and help these countries to achieve the World Health Organization's goal to reduce dengue mortality by 50 percent and morbidity by 25 percent by 2020 in endemic countries. Dengvaxia is also currently approved in Mexico, Brazil and El Salvador, which according to the Pan American Health Organization, collectively bear about 83 percent of the dengue burden in the Americas. ]]> <![CDATA[Zydus receives FDA approval for Doxycycline Capsules ]]> https://biospectrumindia.com/news/95/8027/zydus-receives-fda-approval-for-doxycycline-capsules-.html https://biospectrumindia.com/news/95/8027/zydus-receives-fda-approval-for-doxycycline-capsules-.html Mon, 22 Feb 2016 15:23:11 +0530 Zydus Cadila has received approval from the United States Food and Drug Administration (US FDA) to market Doxycycline Capsules USP, 50 mg, 75 mg, and 100 mg. The drug falls in the anti-bacterials segment. With this first approval, the group will now commence supplies to the US market from its formulation manufacturing facility located at the SEZ in Ahmedabad. The group now has 102 approvals and has so far filed over 280 ANDAs since the commencement of the filing process in FY 2003-04. ]]> <![CDATA[FDA accepts sanofi's NDA ]]> https://biospectrumindia.com/news/95/7994/fda-accepts-sanofis-nda-.html https://biospectrumindia.com/news/95/7994/fda-accepts-sanofis-nda-.html Mon, 22 Feb 2016 14:05:26 +0530 Sanofi announced that the US Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for its investigational fixed-ratio combination of basal insulin glargine 100 Units/mL and GLP-1 receptor agonist lixisenatide for the treatment of adults with type 2 diabetes. Following the redemption of a Priority Review Voucher with the submission, an FDA decision is anticipated in August 2016. "The FDA filing notification is an important milestone for Sanofi as we work to broaden our diabetes portfolio," said Ms Pascale Witz, Executive Vice President, Global Diabetes & Cardiovascular, Sanofi. "Physicians may need to consider fasting and mealtime blood glucose imbalances in their overall management of diabetes, and additional treatment options are needed. We look forward to working with the FDA during the review process with a view toward bringing this investigational medicine to adults with type 2 diabetes in the US" This NDA submission is based on data from two Phase 3 studies, which enrolled more than 1,900 patients worldwide to evaluate the safety and efficacy of the fixed-ratio combination when used in patient populations insufficiently controlled after oral antidiabetic agents (OADs) and after basal insulin therapy, respectively. Both studies met their primary endpoints and will be presented at a medical congress in 2016. The safety and efficacy of the fixed-ratio combination have not been evaluated by any regulatory authority, and the proprietary name is under consideration. Preparations are on track for regulatory submission in the European Union in March 2016. The investigational GLP-1 receptor agonist lixisenatide was evaluated in patients with type 2 diabetes and is also currently under review by the FDA. The NDA for lixisenatide was accepted in September 2015, and an FDA decision is anticipated in July 2016. ]]> <![CDATA[Despite minimal growth in MRSA treatment space to 2024, opportunities will exist for new entrants]]> https://biospectrumindia.com/features/95/7973/despite-minimal-growth-in-mrsa-treatment-space-to-2024-opportunities-will-exist-for-new-entrants.html https://biospectrumindia.com/features/95/7973/despite-minimal-growth-in-mrsa-treatment-space-to-2024-opportunities-will-exist-for-new-entrants.html Mon, 22 Feb 2016 14:04:23 +0530 The Methicillin-Resistant Staphylococcus Aureus (MRSA) treatment market will experience very limited growth over the next decade, rising from $1.4 billion in 2014 to $1.45 billion by 2024, according to research and consulting firm GlobalData. The company's latest report states that the $50 million increase, which will occur across the seven major markets (7MM) of the US, Japan, the UK, France, Italy, Spain, and Germany, represents a very modest Compound Annual Growth Rate (CAGR) of 0.4%. This minimal increase will be largely the product of a treatment space dominated by three primary agents, namely vancomycin, Zyvox (linezolid), and Cubicin (daptomycin). However, Dr Christopher J Pace, GlobalData's Director of Infectious Diseases, emphasizes that opportunities within the market are rife, even with its ostensible homogeneity. Dr Pace says: "Despite its status as the most commonly prescribed antibiotic for MRSA infections, vancomycin has a substantial number of clinical drawbacks. "These include cumbersome dosing criteria, a lack of effectiveness in difficult-to-treat cases, and growing concerns surrounding treatment-emergent resistance. This leaves vancomycin vulnerable to competition from approved and experimental agents." At the same time, Pfizer's Zyvox and Merck's Cubicin, which are frequently employed in MRSA treatment, are both threatened by imminent patent expiries, further opening the market to new and improved players, in addition to increased competition from generics. Furthermore, a number of marketed drugs already indicated for certain types of MRSA infections will achieve label expansions, such as Allergan's Dalvance (dalbavancin) and Merck's Sivextro (tedizolid phosphate) to treat Community-Acquired Bacterial Pneumonia (CABP), and Allergan's Teflaro (ceftaroline fosamil) and Theravance's Vibativ (telavancin) to treat bacteremia. GlobalData's report also states that while cost-effective generic drugs such as vancomycin will curtail substantial growth of the MRSA treatment space over the forecast period, the pipeline features exciting developments. Dr Pace concludes: "While there are no blockbusters on the horizon, the clinical-stage pipeline contains highly innovative approaches to combatting MRSA, as well as novel versions of the existing drug classes. "However, GlobalData anticipates that many new players will establish niches in the MRSA treatment landscape, and will also realize their commercial potential outside of the MRSA therapeutics space." ]]> <![CDATA['UP will not become TB-Free unless there is improved detection of MDR-TB']]> https://biospectrumindia.com/news/95/7843/up-will-not-become-tb-free-unless-there-is-improved-detection-of-mdr-tb.html https://biospectrumindia.com/news/95/7843/up-will-not-become-tb-free-unless-there-is-improved-detection-of-mdr-tb.html Mon, 22 Feb 2016 11:01:45 +0530 Call to Action for a TB-Free India participated at the 70th National Conference on Tuberculosis and Chest Diseases in Lucknow to bring Ministry of Health and Family Welfare, the International Union Against Tuberculosis and Lung Disease, TB Association of India (TBAI) and medical specialists engaged in the care and control of TB came together to review India's efforts in the fight against tuberculosis, a fatal disease that kills over 3 lakh persons in India every year. Dr Sunil Khaparde, deputy director general, TB - Central TB Division, Revised National Tuberculosis Control Programme (RNTCP) announced five key initiatives to improve TB diagnosis and treatment in India under the Revised National Tuberculosis Control Program (RNTCP). "As a step towards achieving the goals outlined in the post-2015 End TB strategy, significant progress has been made by India to control TB in the country under the Revised National Tuberculosis Control Programme (RNTCP), covering a comprehensive spectrum of interventions from enhanced access to TB care services to optimization of available tools, ICT interventions for delivering high quality health services and combating drug resistance thereby saving lives. We are launching a number of important new initiatives- the Daily Treatment Regimen pilot in 5 states under which TB drugs will be administered in fixed doses daily, replacing the existing three times a week treatment; 300 CBNAAT machines to conduct Rapid Molecular Tests for diagnosis of Drug Resistant TB; treatment of multidrug-resistant Mycobacterium TB through Bedaquiline; 3rd line antiretroviral therapy (ART) for HIV patients and daily DOTS regimen in HIV-TB patients; and the TB Missed Call Initiative, a helpline with a toll free number to provide information, counselling and treatment support services for TB," said Dr Khaparde. These initiatives will be implemented by the Central TB Division, Ministry of Health & Family Welfare (MoHFW). The government has also undertaken several other efforts to improve TB diagnosis and treatment in India- Nikshay, a web based solution for monitoring of TB patients; RNTCP modular training for state and district level program managers and trainers; and outreach campaigns for TB control in several cities. But, the incidence of TB in India is so wide and the challenges so complex that a collaborative, multi-stakeholder approach is needed to reduce the burden of TB in the country. According to the World Health Organisation's Global Tuberculosis Report 2015, TB now ranks alongside HIV as a leading cause of death worldwide. India carries the largest burden of tuberculosis with 23% of all TB cases in the world. The direct and indirect cost of TB in India stands at $23.7 billion annually1, inflicting suffering, debt and continued poverty on individuals and families. TB Scenario in Uttar PradeshAccording to the 2015 Annual Status Report on TB published by the Central TB Division, Ministry of Health and Family Welfare, 17 per cent of TB cases under the Revised National TB Control Program (RNTCP), the state-run tuberculosis (TB) are from UP alone. The report also indicates that in 2013, there were over one lakh new TB cases registered in UP. The magnitude of tuberculosis in UP is large- there were close to 13 lakh suspected TB cases in 20142 and this calls for increased action to manage TB and prevent it from turning drug resistant. UP can make progress by focusing on the following:Engaging private sector: Private sector is a critical stakeholder of TB in India. Over 60 percent of all Indians seek care in the private sector, where evidence suggests that quality of care is suboptimal and reporting of data is low. In 2014, only 2.2 TB cases per 1,00,000 were notified by the private sector in UP2. Migration: Drug resistance rates are also proportionally higher amongst migrant labourers who are least likely to seek treatment and frequently evade existing government TB treatment programmes. Migrant workers are often unable to access diagnosis and treatment in the public sector because they lack proof of identity or access to quality services in the private sector. Out-migration is high in UP, so there is a need to increase case detection and ensure treatment adherence across state borders. Need to improve access to quality treatment for TB: For a large population spread across 75 districts in UP, there are only 482 TB units2, which is very low. Need for capacity building among health providers: Only 6 out of 10 medical officers in UP are RNTCP trained2 indicating that the state is not adequately equipped to manage its TB burden. The Revised National TB Control Program (RNTCP) has made progress in TB control. However, increased resources, greater innovation and political support are needed to fast-track progress, especially for MDR-TB. Ms Kavita Ayyagari, project director - challenge TB, the union, noted, "The government, political leadership, corporates, private health practitioners and hospitals, media, civil society organizations (CSOs) and NGOs need to collaborate and leverage each others' strengths to improve outcomes for TB patients in India. We can substantially scale-up our efforts by pooling our resources and expertise and will build inroads into otherwise difficult to reach areas and population. The collective impact of our comprehensive measures will be greater and we'll reach our goals faster." Taking stock of India's efforts in the fight against TB, Dr Khaparde added, "The world is looking at India to take important steps to address issues associated with TB prevention, early diagnosis, access to treatment and preventing drug resistance. We will lead with bold policies and deliver integrated, patient-centred care and support with strengthened research and innovation to make TB Free India a reality." ]]> <![CDATA[FTC puts conditions on Lupin-Gavis deal]]> https://biospectrumindia.com/news/95/7839/ftc-puts-conditions-on-lupin-gavis-deal.html https://biospectrumindia.com/news/95/7839/ftc-puts-conditions-on-lupin-gavis-deal.html Mon, 22 Feb 2016 11:00:30 +0530 Generic drug manufacturers Lupin and Gavis Pharmaceuticals will sell the rights and assets for two generic drugs, one used to treat bacterial infections and the other to treat ulcerative colitis, in order to settle FTC charges that Lupin's proposed $850 million acquisition of Gavis would likely be anticompetitive. The proposed consent order preserves competition by requiring the companies to divest these products to the New Jersey-based generic pharmaceutical company G&W Laboratories. Without a divestiture, the merger would have combined two of only four companies that currently market generic doxycycline monohydrate capsules in two dosage strengths, used to treat bacterial infections, likely resulting in higher prices. The merger also would have eliminated one of only a few companies likely to enter the market for generic mesalamine extended release capsules, used to treat ulcerative colitis, in the near future, thereby delaying beneficial competition and the prospect of price decreases. Under the terms of the proposed order, Lupin is required to transfer to G&W Laboratories all of Gavis's rights and assets related to generic doxycycline monohydrate capsules no later than ten days after the acquisition is consummated, so that G&W can begin selling the product immediately. The transfer includes Gavis's manufacturing technology, which Lupin will help G&W set up at the latter's facilities. In the interim, Lupin will supply G&W with the finished product for two years. The proposed order also requires that Gavis divest its rights and assets related to generic mesalamine capsules to G&W before the acquisition takes place. Gavis's CEO will provide consulting services to help G&W complete the required regulatory work and begin manufacturing the product. Gavis and Lupin also are required to transfer all confidential business data related to both divested products, and provide access to knowledgeable employees, so that G&W can obtain all necessary FDA approvals in a timely manner. Further details about the divestitures are set forth in the analysis to aid public comment for this matter. ]]> <![CDATA[Sanofi Pasteur provides key support to Human Vaccines Project]]> https://biospectrumindia.com/news/95/8109/sanofi-pasteur-provides-key-support-to-human-vaccines-project.html https://biospectrumindia.com/news/95/8109/sanofi-pasteur-provides-key-support-to-human-vaccines-project.html Fri, 19 Feb 2016 12:45:53 +0530 Sanofi Pasteur, the vaccines division of Sanofi, has signed an agreement with the Human Vaccines Project to partially fund the non-profit, public-private partnership convening leading academic researchers and industrial partners to solve the primary problems impeding vaccine/immunotherapy development by "decoding" the human immune system. The Project is a global consortium. Sanofi Pasteur is supporting the Project by providing research funding to oversee, coordinate and conduct the scientific and administrative activities of the Human Vaccines Project Research Program this year. The funds will be used by the Project to launch and execute pilot studies, build partnerships with and across the stakeholder community, and set up the infrastructure and operational support for the Human Vaccines Project Research Program. The Project, which has been endorsed as potentially transformative by 35 of the world's leading vaccine scientists, seeks to raise $1 billion over a decade. The Project was incubated at the International AIDS Vaccine Initiative (IAVI) and is supported by leading academic research centers, industrial partners, and nonprofits to address the primary scientific barriers to developing new vaccines and immunotherapies. "Sanofi Pasteur is proud to join this effort to accelerate and transform vaccine development for major and emerging infectious diseases as well as to better understand human immunology, which may be applicable toward disease management of other chronic disease states," commented Dr Jim Tartaglia, Sanofi Pasteur's R&D vice president for New Vaccine Projects. "The Project's partnerships with industrial and non-profit product developers are key to ensuring that technological breakthroughs are rapidly translated into new products." As a member of the Industry Advisory Committee, Sanofi Pasteur will provide input on the Human Vaccines Project Research Program, review both published and unpublished data, and participate at various scientific workshops to be held by the Project. Sanofi Pasteur will be represented by R&D Vice President for Translational Science & Biomarkers, Dr Kent Kester. "A better understanding of human immunity holds the key to accelerating the vaccine and immunotherapy development for complex global diseases such as HIV, tuberculosis, emerging infectious diseases and cancers," according to Dr Kester. "And since vaccines are among the greatest successes in the history of public health, having led to the eradication of smallpox, near eradication of polio, prevention of 2-3 million deaths per year, and dramatic reductions in human suffering and healthcare costs, the Project makes sense for all of us," he continued. ]]> <![CDATA[FDA breakthrough for Roche's MS drug]]> https://biospectrumindia.com/news/95/8128/fda-breakthrough-for-roches-ms-drug.html https://biospectrumindia.com/news/95/8128/fda-breakthrough-for-roches-ms-drug.html Fri, 19 Feb 2016 12:36:00 +0530 Roche has announced that the US Food and Drug Administration (US FDA) has granted Breakthrough Therapy Designation for the investigational medicine ocrelizumab (OCREVUSTM) for the treatment of people with primary progressive multiple sclerosis (PPMS). There are currently no approved treatments for PPMS, a debilitating form of MS characterized by steadily worsening symptoms and typically without distinct relapses or periods of remission. "Ocrelizumab is the first investigational medicine for MS to be granted Breakthrough Therapy Designation by the FDA," said Dr Sandra Horning, Roche's chief medical officer and head of global product development. "With no approved treatments for primary progressive MS, ocrelizumab has the potential to address an important unmet need. We are committed to working with the FDA to bring ocrelizumab to people with primary progressive MS as quickly as possible." Breakthrough Therapy Designation is designed to expedite the development and review of medicines intended to treat serious or life-threatening diseases and to help ensure people have access to them through FDA approval as soon as possible. The designation is based on positive results from the pivotal Phase III study (called ORATORIO), which showed treatment with ocrelizumab significantly reduced disability progression and other markers of disease activity compared with placebo. Top-line results were presented at the 31st congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in October 2015. Roche plans to pursue marketing authorisation for both PPMS and relapsing multiple sclerosis (RMS), a more common form of the disease, and will submit data from three pivotal Phase III studies to global regulatory authorities in the first half of 2016. OCREVUSTM is the proprietary name submitted to global regulatory authorities for the investigational medicine ocrelizumab. ]]> <![CDATA[Respiratory Syncytial Virus treatment market to surpass $2.3 bn by 2024]]> https://biospectrumindia.com/features/95/8104/respiratory-syncytial-virus-treatment-market-to-surpass-2-3-bn-by-2024.html https://biospectrumindia.com/features/95/8104/respiratory-syncytial-virus-treatment-market-to-surpass-2-3-bn-by-2024.html Fri, 19 Feb 2016 12:25:34 +0530 The global Respiratory Syncytial Virus (RSV) treatment market will expand to unprecedented levels over the next decade, rising from approximately $640 million in 2014 to over $2.3 billion by 2024, representing an impressive Compound Annual Growth Rate (CAGR) of 29.9 percent, says research and consulting firm GlobalData. According to the company's latest report, this robust growth, which will occur across the seven Major Markets (7MM) of the US, France, Germany, Italy, Spain, the UK, and Japan, will be driven by multiple new product launches in the currently sparse RSV arena. Dr Christopher J Pace, GlobalData's Director of Infectious Diseases, states that Synagis (palivizumab) is the only licensed product indicated for the prevention of RSV in infants at a high risk of severe infection, and there are no prophylactic agents approved for adults. Dr Pace explains, "Despite Synagis being effective in many patients, its short half-life and prohibitively high cost limit its utility. "However, the anticipated launches of novel prophylactic monoclonal antibodies (mAbs) led by MedImmune's MEDI8897 and Regeneron's REGN2222, have provided hope for more cost-effective alternatives to Synagis. GlobalData expects these pipeline agents will be important players in the RSV space across the 7MM by 2024." In addition, the anticipated licensure of the first adult vaccine to offer protection against RSV, Novavax's RSV-F Vaccine, will also stimulate rapid growth in a previously untapped segment of the RSV marketplace, with elderly patients, especially those living in nursing homes, driving the uptake of this vaccine. Dr Pace continues, "These new products come at a time when RSV presents a growing socioeconomic and public health burden. New game-changing agents will be enthusiastically welcomed, particularly as healthcare stakeholders are becoming increasingly open to novel interventions that may provide indirect cost-savings by shortening, or even outright preventing, hospital stays. "Despite the RSV treatment market's promising prospects, there will be formidable logistical and financial hurdles to overcome in order to successfully assimilate novel RSV vaccines into existing immunization program infrastructure. However, such barriers will not hinder exciting market growth to 2024." ]]> <![CDATA['Focus on disruptive technologies to boost Make in India']]> https://biospectrumindia.com/news/95/8285/focus-on-disruptive-technologies-to-boost-make-in-india.html https://biospectrumindia.com/news/95/8285/focus-on-disruptive-technologies-to-boost-make-in-india.html Fri, 19 Feb 2016 11:30:31 +0530 A new study, 'Make in India: How could we be strategic?' has identified five key technologies as having the maximum potential to stimulate growth in Indian manufacturing: biotechnology, nanotechnology, micro and nanoelectronics, photonics, and advanced materials. These five knowledge intensive technology areas have wide-ranging applications across various industrial sectors with the potential to meet national security priorities, stimulate economic growth as well as meet social development imperatives. The study by the Council on Energy, Environment and Water (CEEW) was released days after the introduction of the National Capital Goods Policy during the Make in India Week programme in Mumbai. The National Capital Goods Policy includes a provision for a Technology Development Fund and other commitments such as increasing skill availability, ensuring mandatory standards and promoting growth and capacity building of Micro, Small and Medium Enterprises (MSMEs). The study identifies how to deploy the fund most effectively. Mr Vaibhav Gupta, junior research associate, CEEW, said, "Our analysis finds that a large share of the total manufacturing output (calculated in terms of gross value addition) can be impacted by the identified technologies: Biotechnology (15 percent), nanotechnology (86 percent), micro and nanoelectronics (100 percent), photonics (19 percent), and advanced materials (40 percent)." However, the existing innovation support system to help translate research efforts across these identified technologies and other areas into commercial products is nascent in India. One key hurdle preventing India from becoming an innovation hub is the abysmal participation of the private sector in R&D, by way of financing. The private sector contributes to less than one-third of the overall R&D spending in the country due to the associated risks in investment and technology failure. Importing components and licensing of intellectual property (from overseas) is the current approach across the strategic sectors. In the long run, this presents the biggest threat to innovation in India. The study recommends that the public sector must don the role of 'risk capital' provider and move away from granting soft-loans for research to a royalty based system that allows for revenues to flow back to the public corpus, should the idea become a commercial success. As a solution the study also showcases the design of a centralised one-stop technology information portal that provides a range of information - open funding opportunities, status of existing grants, outcomes, partner opportunities, etc. Such an extensive database could help identify emerging areas of research, reduce doubling of effort, target limited resources more strategically, and assess the impact of R&D investments especially in facilitating more links between technology developers and industry. Another key challenge is the inefficient and understaffed Indian Patents Office (IPO). The IPO has an ever increasing backlog of unexamined patents and trademark applications. In 2012 there were 123,255 pending patent applications, which have further increased to 246,495 pending patent applications (in addition to the 532,682 pending trademark applications) in 2015. IPO staff in India experience the highest per capita workload (20 applications a month, as compared with seven in Europe and China, eight in the United States) at the lowest pay. However, 490 patent personnel have been recently recruited to improve the efficiency of the Indian Patent Office. The study suggests that capacity expansion of the IPO (both funding and manpower) and outsourcing 'prior-art' searches to third party service providers will significantly improve the efficiency of the patent filing and approval process. In addition, fast-track IP courts for patent infringements and a patent prosecution highway would accelerate patent prosecution procedures. A fee based revenue model is necessary to enable the IPO to sustain its operations in the long run and operate in autonomy. The third significant factor hampering the pursuit of strategic technologies is the quality and standards associated with domestically manufactured finished-goods and intermediates. Indian industry, to remain competitive and keep costs lower, must have significant backward integration with domestic suppliers of components and raw materials. However, in many cases the physical and chemical properties of intermediates and raw materials do not meet international (or even) national standards. This in turn, adversely impacts the quality of final products. The study finds a pivotal role for an accreditation entity such as (NABL) to certify the bulk of testing laboratories across the country. Currently, only one percent of the laboratories are accredited by NABL. To promote the development of quality products in the five identified areas, mandatory certification of products enabled by these technologies must be enforced. This will set the bar for new entrants and create a larger market for domestically manufactured goods. Dr Arunabha Ghosh, CEO, CEEW, said, "For a competitive manufacturing driven economy, we have to focus on three transitions: from resource vulnerability to securing resources, from acquiring technology from overseas (for domestic use) to developing high technology domestically, and from education and skills to R&D and innovation. A slew of reforms identified in the study are necessary to set the innovation ecosystem in India right. Creating this sustaining eco-system must be made an important objective of the Make in India campaign." . ]]> <![CDATA[Growth in finished dosage formulations sees CPhI introduce new event ]]> https://biospectrumindia.com/news/95/8428/growth-in-finished-dosage-formulations-sees-cphi-introduce-new-event-.html https://biospectrumindia.com/news/95/8428/growth-in-finished-dosage-formulations-sees-cphi-introduce-new-event-.html Fri, 19 Feb 2016 11:26:10 +0530 CPhI Worldwide, organised by UBM EMEA, formally introduces a new co-located event entirely dedicated to Finished Dosage Formulation (FDF) following a soft launch amongst exhibitors in 2015. This new event will open at the 27th CPhI Worldwide in Barcelona (4-6 October 2016) and reflects the huge growth in finished dosage formulations across the wider pharma market. The next stage in the pharma event's introduction is to target new potential visitors and attendees through a sustained marketing and branding effort. FDF will gather together the entire supply chain in one location at CPhI WW, from Big Pharma and CMO, to out-licensing and dossier specialists, end product distributors, generic pharma companies, and home markets. It will act as a global meeting-point for any company looking to grow, launch or distribute finished formulations in international or national markets. Over the last few years, sales in the pharmaceutical supply chain have accelerated across commercial supply and final dosage forms, where more complex solutions and higher margin products are common. Pharma companies seeking partners with new formulations, and the rise in complex and difficult to formulate compounds are driving the growth in this market. Additionally, CPhI stated, generics and the increasing use of out-licensed formulations are a key factor behind its decision. In fact, since the introduction of the FDF zone at CPhI Worldwide in 2011, it has quickly grown to be the third largest part of the show totalling over 11,000 m2 in 2015. Dosage forms represented will cover all types of solid dose, semi-solids, liquids, sprays and steriles from both pharma and biologics companies, including tablets, capsules, gels, parenteral drugs, vials, patches, creams, inhalation, nasal, sublingual and suppository. Mr Rutger Oudejans, brand director pharma at UBM EMEA, commented, "Finished dose formulations are already a huge part of CPhI Worldwide. And, both within the wider market and in terms of exhibitor numbers, it is one of the fastest growing areas in pharma. Our aim in 2016 is to cement FDF's reputation as the essential platform for launching and conducting business in the global finished dose market." Mr JosÃ© Escaich, chief executive officer at Bioberica SA, added,"Being at FDF is an incredible opportunity for BioibÃ©rica to nurture new and previous business relations. We are the leading Western producer of heparin (the world's most commonly used anticoagulant and antithrombotic) and leaders in osteoarthritis and joint health. This year's CPhI Worldwide will be special to us for three reasons: it will be held "at home", in Barcelona; it is the celebration of the Centenary of the discovery of Heparin - we deliver 1/5 of the heparin doses in the world; and we are positioning our stand at the centre of the new co-located Finished Dosage Formulation event. BioibÃ©rica has been present at CPhI Worldwide since its beginning, and this year FDF provides a great opportunity for us to present our products to a dedicated audience." FDF will be supported by its own dedicated content, and a more prescriptive 1-2-1 matchmaking platform, which will enable professionals within this supply chain to explore the latest developments, strategies and market analysis. Topics will include everything from the regulatory approvals, processes and changes, to key growth markets, new formulation technologies, distribution and commercialisation. Ms Cara Turner, event manager at UBM EMEA for FDF, added, "Whilst a number of our attendees do indeed work across both API and commercialized products, we took the decision to dedicate a co-located event to those looking to concentrate on finished product supply. In practical terms, this means we have created new content, sessions, networking and the best new business opportunities in one place. This way our attendees and exhibitors can more quickly identify leads through our company matchmaking platform and move between potential clients and customers. By launching FDF, we are creating the ideal set of conditions for exploring this thriving sector. So beyond the customers and potential clients attendees arrange meetings with, there is undoubtedly a wealth of further opportunities available from just exploring this part of the exhibition floor." ]]> <![CDATA[Cipla completes acquisition of generic businesses in US ]]> https://biospectrumindia.com/news/95/8110/cipla-completes-acquisition-of-generic-businesses-in-us-.html https://biospectrumindia.com/news/95/8110/cipla-completes-acquisition-of-generic-businesses-in-us-.html Thu, 18 Feb 2016 12:56:31 +0530 The acquisition was made by Cipla (EU) Limited through a wholly owned special purpose vehicle which would merge into InvaGen Pharmaceuticals Inc. after the acquisition. The combined revenue for the two companies for the year-ended 2015 is over USD 230 million. This acquisition is the second landmark acquisition in Cipla's 80 year history - the first was Cipla Medpro, South Africa. The acquisition will give scale to Cipla's US business - currently 8% of total revenue as well as providing a launch pad to introduce Cipla's pipeline of products in respiratory and injectables, among others, in the coming years. Combined with the pipeline of InvaGen products, the overall portfolio will be wide-ranging and will cover chronic therapies like CVS, CNS, respiratory, oncology and diabetes among others. The acquisition of InvaGen pharmaceuticals also provides Cipla with about 40 approved ANDAs, 32 marketed products, and 30 pipeline products which are expected to be approved over the next 4 years. In addition, InvaGen has filed 5 first-to-file products. Dosage forms include immediate release, modified release and extended release tablets and capsules. With a manufacturing footprint of ~350,000 sq.ft of GMP area, InvaGen has 3 units located in Long Island, NY, with a total production capacity of 12 billion tablets and capsules per annum and about 500 employees. With this acquisition, Cipla will have more relevance to wholesale and retail customers. Commenting on the acquisition, Mr Umang Vohra, Global Chief Operating Officer, Cipla Limited said: "The acquisition will further strengthen Cipla's presence in the US pharmaceutical market. InvaGen's balanced portfolio, robust manufacturing base and strong R&D capabilities will act as lever to expand Cipla's reach in the US market." ]]> <![CDATA[Gender Disparity in Biosciences]]> https://biospectrumindia.com/features/95/8484/gender-disparity-in-biosciences.html https://biospectrumindia.com/features/95/8484/gender-disparity-in-biosciences.html Thu, 18 Feb 2016 12:56:02 +0530 Though number of women seeking higher education like PhD /Post docs are increasing, yet we do not see equal amount of work force either in research or in industry, even less in scientific advisory boards. BioSpectrum spoke to a number of women in research, academia and entrepreneurs and try to find out the reason behind the gender inequality in the bioscience sector and how it can be reversed. Gender Gap in Biosciences:One of the key reason for the lack of gender parity is social conditioning. The primary work of women is considered to take care of her family and do household work. "Traditionally, a woman is expected to focus on home, hearth, and children. With all distractions in her life, career seems to be the easiest to compromise. Even if she overcomes all odds and carves a career for herself, she is viewed as a woman first and a scientific expert or a doctor next. This doesn't do much to her self-belief. There are few who beat all odds and break the glass ceiling," said Ms Anu Acharya, CEO, Mapmygenome. Speaking on the similar lines, Dr Geetaa Singh, director, Labland Biodiesel said, "Research requires an extremely high level of commitment and dedication to the extent of exclusion of a personal life. Science cannot just be treated as a '9 to 5'job. It calls for a certain lifestyle. An ambitious and driven personality is key to surviving in this field. It requires a strong family and drive for making a career in research for a woman to succeed, which is probably not as easy to come by as one would hope."Another reason for the high attrition in the work force when women start families is lack of proper institutional support for married women. Dr Radha Rangarajan, co-founder and CEO, Vitas Pharma said, "I think that we provide women with very little institutional support to help them balance their careers and family life. Few work places have childcare support on site. It is also not easy to find good quality childcare help in India, leaving women to rely on their mothers or mothers-in-law to help them. Many women leave the workforce at this time, unable to cope with the stress. Re-entry into the work force three to five years later is often very hard and again, without support from family, she may not make it back successfully even at this stage. If the number of women able to sustain their careers is small, it is no surprise that there are fewer women at the top." Gender Disparity: A global Phenomenon?Gender inequality is a widely global phenomenon, however, in India it is heightened due to social and cultural system that sets the priority on the role a woman has to play-with family coming first and career second. "The situation is bad globally. However, in the west, men are more likely to stay at home and take care of the children. Also, women do not give up their jobs to take care of elderly members in their family that often," said Ms Acharya. "A man's range for tasks/load can be completely work-oriented, as much as 95 percent work: 5 percent family, whereas the least a woman has to compulsorily manage is a 50:50. This 50:50 in percentage is actually a 100:100 on tasks/load, because in most places of work, women have to clock the same no. of hours of work as men and then cater to the 100 percent expected from family. Just as there are only so many hours in a day, there is only so much energy in any person, man or woman, on a daily basis," said Ms Bharathi Sriram, vice-president R&D at GangaGen. She added, "In the Indian woman context, this quantum is proportioned for career and family and getting through each day. With the added stress factors of distances and commuting in the city, the negative impact on health and productivity of women can be clearly envisaged." As per Dr Shailja Vaidya Gupta, director, International Cooperation, Department of Biotechnology (DBT), "Yes, disparity exists worldwide, it's a global phenomenon. The developed world from what I understand still has pay/wage disparity based on gender. This is not so in India. In that sense the government has provided great incentives for the working women in tax rebates, property registration etc." Does the present system allows for work-life balance/women-friendly? In answer to the question, majority of them praised the government's esp. the central governments' schemes for women, however the same cannot be said for private companies. "Yes, the Government has been very supportive of women employees. Apart from the six month maternity leave, all Govt. women officers are allowed 2 years of child care (paid) leave, (CCL) till the child is 18 years. CCL is not available for the male counterpart. I personally and I reiterate it's my personal opinion that the CCL, which is different from the maternity leave, reinforces gender roles, that of child care being the responsibility of the mother. A parent care leave would have been more appropriate, child care being as much a responsibility of the father as that of mother. This gives the message signal that the government has decided that the mother belongs at to the home to take care of the children, a deterrent to gender equality," said Dr Gupta. Dr Bula Choudhury, Research Scientist, Guwahati Biotech Park, IIT Guwahati said, "In the R & D sector, different Government funding schemes has been launched where woman can engage themselves after having a career break, like Woman Scientist Program of DST. Long duration child care leave for woman is a very good move by the govt." These schemes should be implemented in state govt. as well as in private sector. "The policy makers in the industry are largely men, therefore, it is not recognized that work-life balance issues are distinct and different for women. Women would have to be given allowances in terms of flexibility in work-hours when required," said Ms Sriram. Equal opportunities for Men and Women? By and Large, remuneration and promotion are almost equal for both men and women in the sector. Dr Rangarajan believes though equal opportunities are given but women often pass up these opportunities to balance their responsibilities at home. "I have rarely, if ever, seen a man do that," she said. "Routine promotions are more or less same, for I speak for the government sector only however, where promotions to leadership position are concerned there is a definite glass ceiling. Look at the universities, some 700 odd universities, all with sizable women faculty, but only three percent of them have women VCs. We are ready to accept average mediocre men in leadership positions but women are not so lucky," said Dr Gupta. She continues, "One senior women bureaucrat now retired, was overlooked for cabinet secretary position because the then PM was not comfortable with a women cabinet secretary who would be called upon to work 24/7. The fact that the woman bureaucrat was the topper of her batch with a brilliant track record and willing to work 24/7 did not make a difference. These archaic and deep set mindsets are the biggest challenge a women has to face." Sometimes women executives are also responsible for not getting the promotion. Some bring household problem in office, others are not aggressive enough to meet their target. "Most of the time if there is a lady and a man for one promotion, both equally deserving, the promotion goes to the man. It's the conventional thinking, that decision makes believe that the man will put more effort for the company, which is always not the case," said Ms Monisha Hajra, founder, ScientiaBio. STEM: Male dominated career?Traditionally, STEM (science, technology, engineering, and mathematics) is seen as a male-dominating career. Men often outnumber women in in these fields."This is true, and enough reasons have been given through history for this, cultural, the way we bring up a boy and girl, the options given to them and even the developed/ undeveloped right and left side of the brain. This will change rapidly when parents, teachers and the students themselves start believing that all subjects are equal. Remember women have had a lag start time in terms of education and more so in STEM education so there is a lot of catching up to do," mentioned Dr Gupta.Lack of a personal and social life in addition to difficulty in maintaining a work-life balance makes it difficult for women to succeed in science. "The case of women in the STEM funnel resembles our famous drug discovery, one where you start with thousands of compounds and end up with a handful of possible targets. Similarly, women make up 50 percent of the population but only a handful make it to the top," said Ms Acharya. Things are changing for good however, ratio of women: men in STEM fields is improving. "Not all branches of STEM are equally male dominated. The biological sciences, for example, has lots of women," said Dr Rangarajan. "Traditionally, yes, it has been so considered. It is changing now. If you look into technology areas and in medicine, engineering and technical streams, you will see at least 40 percent girls on averaging. Given a few generations, there will be more women excelling in the STEM than men," Ms Sriram said. Woman scientist schemes: The DBT`s Woman scientist scheme is helping the women. The Biotechnology Career Advancement & Re-orientation Programme (Bio-CARe) scheme to facilitate participation of women scientists in biotechnology research is a very good scheme for woman working in North Eastern Region which is having two segments viz. Research Grant Opportunity (RGO) and Career Re-orientation Fellowship (CRF).The purpose of RGO is to build capacities for women scientists employed fulltime in universities and research laboratories or unemployed women scientists after a career break so as to help them undertake independent R&D projects. "Dr K Vijay Raghavan, secretary, DBT has made it mandatory to have 30 percent women representation in DBT Task Forces and in my opinion I think he has been instrumental in getting women Directors in CDRI (Dr Madhu Dikshit) and Sri Chitra Institute (Dr Asha Kishore)," says Dr Gupta. DST has also initiated programmes for women. Women Scientists Scheme (WOS-A) aim to provide opportunities to women scientists and technologists for pursuing research in basic or applied sciences in frontier areas of science and engineering. A special provision has been made under this scheme to encourage those women scientists who have had break-in-career. Another such scheme is Women Scientist Scheme WOS-B (SoRF). Its objective is to bring back the women scientists and technologists in main stream after break in their career, provide platform and training to women scientists and encourage women scientists and technologists to apply their S&T training towards innovative solutions to address various societal issues. Bridging Gender Gap:To promote female advancement in the STEM fields, we need families to value women professionals and recognize the contribution they are making to the family and to the country. "However, all these wouldn't work if we don't change the mindset of families and the society. Families can motivate women to do better and build a strong support system. In a healthy society, a woman's achievements are not discounted or viewed as a threat," said Ms Acharya. Gender gap is mainly due to disparity that links to work-life balance. Institutional support is unheard in India. Day care centers that provide care for infants are not very common either. "In the west, in all the places I studied and worked at, day care facilities were available minutes away. When I was a student at Rockefeller University in New York, day care was available on campus and subsidized for students. When I was a postdoctoral fellow at the Harvard School of Public Health, day care was five minutes away. I went back to work when my elder daughter was 4 months old. Proximity to the work place allowed me the option of visiting her in the middle of the day, if needed. In India, the idea of on-site daycare has simply not caught on. But for employers keen on retaining their women employees, there cannot be a bigger carrot than this," said Dr Rangarajan. Career opportunities for mothers returning to work can also contribute to bridging this gender gap. Dr Choudhury believes to close this gap an organization should follow some policies like transparency during recruitment, promotion and wage fixation for man and woman, monitoring of gender equality and re-entry opportunities for woman. "I have recently been though a book titled "Why Women Mean Business" by Avivah & Alison. In that book they had shown some of example case studies (like PwC, Nestle, Nissan etc) how some companies have taken adequate measure to close the gap. One example is ICICI Bank. As per that book 25 percent of ICICI bank senior managers are women. So the company board also has to proactively take measures in closing the gap which will eventually help them in boosting company performance," said Ms Hajra. The other most important thing is to train more men on gender parity, agrees Dr Gupta. She added, "Gender gap will narrow down in due course of time. We need empathetic, open minded men on our side who understand the importance of to an equal workforce. The involvement of men in bridging the gender gap cannot be underestimated. Men who are willing to listen to and respect the opinion of women, are important." Dr Rangarajan echoes similar sentiments, "Unless we start to value women's careers on par with men's and bring in change to support them through the child bearing years, we will continue to see a low level of representation at higher levels in industry and academia." Word of Wisdom: Advice to the young female entrepreneurs/researchers from some of the women currently holding top position in the Industry.Your goal will turn your way with dedication, determination, hard work and an attitude of never give up. Be bold, optimistic, communicate with your superior directly. Work hard, be determined. Never compromise with your dream. Work fearlessly with great deal of competence and an eye for detail. Never bother about what your colleagues, male or female, have to say about you. Make a Choice, Respect your choice, Believe in yourself. Work hard and do not let anything come in your way to achieve till you achieve what you aimed at. Don't give up half way through no matter what challenges come your way. Do not let yourself be intimidated or overwhelmed by non-professional views. The only thing that should speak for the candidate is your competence and performance in the chosen field. The road ahead may not be smooth, but staying motivated and passionate about your goals can help. Dream, but work hard to convert your dreams to reality.Trying to balance work and family life is not easy. But with passion and commitment one can navigate the tangle. I believe that one must lead a purposeful life; so choose a career that gives fulfillment, not just material wealth. You have to believe that in the end, the hard work pays off. Top Women in the biosciences sector:Below are some of the women's who fought against all odds to capture the top spot in the industry:Ms Anu Acharya, CEO, Mapmygenome Ms Bharathi Sriram, vice president R&D at GangaGenDr Bula Choudhury, research scientist, Guwahati Biotech Park, IIT Guwahati.Dr Deepanwita Chattopadhyay, CEO, IKPDr Geetaa Singh, director, Labland BiodieselDr Manju Sharma, former secretary, DBT Dr Radha Rangarajan, co-founder and CEO, Vitas Pharma.Dr Renu Swarup, adviser, DBT and MD, BIRACDr Villoo Patell, founder and CMD, Avesthagen Dr Kalpana Krishnaswami, CEO at Metaome.Dr Kiran Mazumdar Shaw, CMD, BioconDr Malathi Lakshmikumaran, director and practice head, Lakshmikumaran and Sridharan Attorneys Dr Meenakshi Bhat, consultant in Clinical GeneticsMs Monisha Hajra, â€?founder at ScientiaBio Dr Purnima Sharma, MD, BCIL Dr Shailja Vaidya Gupta, director, International Cooperation, Department of Biotechnology (DBT) Disclaimer: The views expressed in the story are personal and does not necessarily reflect the views of the organizations they are associated with. ]]> <![CDATA[Alzheimer's market will more than double to $10.4 bn by 2021 ]]> https://biospectrumindia.com/features/95/8096/alzheimers-market-will-more-than-double-to-10-4-bn-by-2021-.html https://biospectrumindia.com/features/95/8096/alzheimers-market-will-more-than-double-to-10-4-bn-by-2021-.html Thu, 18 Feb 2016 12:48:08 +0530 The Alzheimer's disease market will more than double from just under $5 billion in 2014 to an estimated $10.4 billion in 2021, at a Compound Annual Growth Rate (CAGR) of 11%, according to business intelligence provider GBI Research. The company's latest report states that such impressive growth, which will occur across the eight major markets (8MM) of the US, Canada, France, Germany, Italy, Spain, the UK, and Japan, will be primarily driven by increased disease prevalence during the forecast period. Mr Yasser Mushtaq, Senior Analyst for GBI Research, says Alzheimer's disease is significantly more common in the older population and incidence rates increase rapidly after the age of 65. He comments: "The fact that people are living longer across the globe means more cases of the disease are developing, and this has posed a growing public health crisis, which represents a very serious disease burden for patients and carers alike. "Despite the urgent need to develop more effective treatments for Alzheimer's disease, thorough research is being carried out into understanding the disease, as its underlying pathology remains unknown. "However, these extensive studies have helped to develop the research and development process within this indication, providing hope for the future of Alzheimer's disease therapeutics." GBI Research also states that although disease prevalence will be the strongest driver of market growth, innovation in the pipeline will also be a factor. Mr Mushtaq explains: "While many of the later-stage therapies focus on common targets, the earlier stages of the pipeline do not appear to follow this trend, as they contain many first-in-class molecules with novel molecular targets within the context of Alzheimer's disease therapeutics. "The primary new approvals for drugs that will drive growth during the forecast period will supplement current market leaders and offer greater therapeutic options. Promising examples include verubecestat, aducanumab and azeliragon, all of which have demonstrated clinical benefit and will be approved during the forecast period." ]]> <![CDATA[APAC breast cancer market will rise substantially to $3.4 bn by 2021]]> https://biospectrumindia.com/features/95/8095/apac-breast-cancer-market-will-rise-substantially-to-3-4-bn-by-2021.html https://biospectrumindia.com/features/95/8095/apac-breast-cancer-market-will-rise-substantially-to-3-4-bn-by-2021.html Thu, 18 Feb 2016 12:34:46 +0530 The Asia-Pacific (APAC) breast cancer market is set to experience considerable expansion from $1.9 billion in 2014 to $3.4 billion by 2021, at a robust Compound Annual Growth Rate (CAGR) of 8.5%, according to business intelligence provider GBI Research. The company's latest report states that such growth, which will occur across the APAC regions of India, China, Australia, and Japan, will be driven by aging populations, changing lifestyle habits, improved survival rates, and a number of new approvals for drugs that are expected to supplement current market leaders. Ms Deekshita Allavarapu, Analyst for GBI Research, explains: "It is anticipated that popular drugs, such as Afinitor and Herceptin, will be used in conjunction with several promising breast cancer pipeline treatments. These include abemaciclib, buparlisib, LEE 011, olaparib, and Neuvax, all of which are forecast to be approved by 2021 and have shown significant clinical benefit in trials. "Such therapies are on the rise due to their increased use in conjunction with chemotherapy. In addition, the strong efficacy profile of targeted therapies has resulted in favorable reimbursement and increased uptake in Japan and Australia. This is despite the drugs' premium pricing, which reflects the cost associated with their development and the significant therapeutic benefit offered." However, the analyst notes that in India and China, even after premium targeted treatments become available, only patients in the richer territories will be given these drugs, as patients in the poorer districts will not be able to afford them due to a lack of social insurance and inadequately publicly subsidized services. GBI Research also states that applying for reimbursement for oncology drugs in Australia is becoming more difficult due to a time-consuming and complex regulatory and reimbursement process prior to access, which causes a substantial delay in patient access. "These factors limit the uptake of premium-priced therapies, which somewhat restricts overall breast cancer market growth. Nonetheless, the sheer size of the APAC populations means that, even if a relatively small percentage of patients are eligible for treatment, there will be high levels of revenue," Ms Deekshita concludes. ]]> <![CDATA[Dr Reddy's to buyback its equity shares ]]> https://biospectrumindia.com/news/95/8282/dr-reddys-to-buyback-its-equity-shares-.html https://biospectrumindia.com/news/95/8282/dr-reddys-to-buyback-its-equity-shares-.html Thu, 18 Feb 2016 11:18:16 +0530 The Board of Directors of the Company in their meeting held on 17th February, 2016 has approved a proposal to buyback Equity Shares of the Dr Reddy's Laboratories. It is subject to approval by the shareholders, for an aggregate amount not exceeding Rs 15,694 million (hereinafter referred to as the "Maximum Buyback Size") and (being 14.9 percent of the total paid-up equity capital and free reserves of the Company as on March 31, 2015 (being the date of the last audited accounts of the Company), at a price not exceeding Rs 3,500 per Equity Share (hereinafter referred to "Maximum Buyback Price" and such Buyback the "Buyback") from all shareholders of the Company (including persons who become shareholders by cancelling American Depository Shares and receiving underlying Equity Shares, and excluding the promoters and promoter group of the Company). Under the open market route in accordance and consonance with the provisions contained in the Securities and Exchange Board of India (Buy Back of Securities) Regulations, 1998 ("Buyback Regulations") (including any statutory modification(s) or re-enactment of the Act or Buy-back Regulations, for the time being in force) and the Companies Act, 2013 and rules made thereunder. In accordance with the provisions of Regulation 15(b) of the Buy-Back Regulations, the Buyback shall not be made from the promoters and promoter group of the Company. The Maximum Buyback Size, excludes transaction costs viz. brokerage, applicable taxes such as securities transaction tax, service tax, stamp duty etc ("Transaction Costs"). The Maximum Buyback price represents 18.6 percent premium, compared to the average of the weekly high and low of the closing share price of the Company during the last two weeks (i.e. up to February 16, 2016). The Buyback is proposed on account of the Company's strong cash flow position and is expected to be EPS accretive contributing to an overall enhancement of value for shareholders going forward. The proposed Buyback is subject to approval of the shareholders of the Company, by way of a special resolution through postal ballot (including e-voting) and other regulatory approvals, permissions and sanctions, as may be required. Once approved, the public announcement setting out the process, timelines and other statutory details will be released in due course in accordance with the Buyback Regulations. The actual number of Equity Shares bought back, will depend upon the actual price, excluding Transaction Costs, paid for the Equity Shares bought back and the aggregate consideration, paid for the Buyback, subject to the Maximum Buyback Size. At the Maximum Buyback Price and for the Maximum Buyback Size, the indicative maximum number of Equity Shares bought back would be 4,484,049 ("Maximum Buyback Shares") (comprising around 2.6% of the existing paid-up capital). If the Equity Shares are brought back at a price below the Maximum Buyback Price, the actual number of Equity Shares bought back could exceed the indicative Maximum Buyback Shares, but will always be subject to the Maximum Buyback Size. The Company shall utilize atleast 50 percent of the amount earmarked as the maximum Buyback Size for the Buyback Offer i.e. Rs. 7,847 million (comprising around 7.45 percent of the existing total paid-up equity capital and free reserves of the Company as on March 31, 2015) ("Minimum Buyback Size"). Based on the Minimum Buyback Size and the Maximum Buyback Price, the Company will purchase a minimum of 2,242,024 (comprising around 1.3 percent of the existing paid-up capital), Equity Shares. The Company has also appointed Kotak Mahindra Capital Company Limited as its Merchant Banker for the Buyback process. ]]> <![CDATA[Zika Virus urgently needs improved detection methods as vaccine development faces array of obstacles ]]> https://biospectrumindia.com/features/95/7293/zika-virus-urgently-needs-improved-detection-methods-as-vaccine-development-faces-array-of-obstacles-.html https://biospectrumindia.com/features/95/7293/zika-virus-urgently-needs-improved-detection-methods-as-vaccine-development-faces-array-of-obstacles-.html Wed, 17 Feb 2016 13:10:42 +0530 The growing threat of the Zika virus, which the World Health Organization (WHO) believes could infect four million people in the Americas over the next twelve months, must be addressed using a multi-pronged approach, according to an analyst with research and consulting firm GlobalData. Dr Mirco Junker, GlobalData's Analyst covering Infectious Diseases, says that while a vaccine could be an effective measure in the long term, it remains several years away and faces numerous obstacles to development. As such, limiting people's contact with mosquitoes and developing effective diagnostic tests are more crucial short-term measures. Dr Junker explains: "The first step in fighting the Zika virus is to address the vector responsible for its transferral to humans - mosquitoes. Achievable actions, such as eliminating shallow standing water, using insecticides, and implementing next-generation genetic or microbiological approaches, would all contribute to the reduction of Zika vector populations. "Furthermore, the development of a reliable and cost-effective method to detect Zika infections is of paramount importance. The test would need to be sensitive and specific, with high cost-effectiveness, so that it may be employed on a large scale and be able to detect the large proportion of disease cases which are asymptomatic." The analyst adds that while an effective long-term solution would be a vaccine that offers strong and durable protection against Zika, this could take years to become a reality. Dr Junker continues: "Several companies, including GlaxoSmithKline, Merck, Johnson & Johnson, Pfizer, and Sanofi, have already expressed interest in developing a Zika virus vaccine, but the current lack of scientific data on Zika presents a major barrier. "The development of Sanofi's vaccine for dengue, a disease carried by the same type of mosquito as Zika, has taken 20 years, and its efficacy in certain patient populations, most notably flavivirus-naÃ¯ve individuals, has still not been definitively proven. "Therefore, even though the Zika virus has been sequenced, it is currently not clear what the best approach in developing a Zika virus vaccine will be, and a definitive timeline on vaccine development is impossible to ascertain." ]]> <![CDATA[Experts address challenges posed by new classes of drugs: Proteins and Peptides]]> https://biospectrumindia.com/news/95/7898/experts-address-challenges-posed-by-new-classes-of-drugs-proteins-and-peptides.html https://biospectrumindia.com/news/95/7898/experts-address-challenges-posed-by-new-classes-of-drugs-proteins-and-peptides.html Wed, 17 Feb 2016 13:09:06 +0530 The workshop provided a platform to examine the trends and issues related to the analytical characterization and impurities of therapeutic peptides and proteins from a compendial and industry perspective. Today, therapeutic proteins and peptides are the fastest growing classes of drugs and as with most emerging research therapies, have many challenges that need to be addressed. Speakers at the workshop included representatives from USP, the United States Food and Drug Administration (FDA), the European Directorate for the Quality of Medicines (EDQM), the Indian Institute of Science Education & Research (IISER) and leading pharmaceutical experts from India and other countries. During the workshop, USP also presented an update on the development and modernization of relevant USP standards, accompanied by case studies and panel discussions. Other participants in the workshop were analytical chemists, R&D scientists, contract research organizations, and academic scholars from various educational institutions. As to the purpose of the workshop, Dr Koduru V Surendranath, senior vice president, global sites and senior vice president of USP-India said, "Such events are invaluable for sharing of best practices, nationally and globally. They encourage collaboration and provide impetus for the discovery of newer treatment avenues. They also serve to ensure that the highest quality standards are maintained in the process." In an effort to increase collaboration and exchange of valuable, current information among industry experts, USP-India has previously held other significant workshops and programs such as the Pharmacopeial Education and Training (PE), created to support the appropriate use of the United States Pharmacopeia-National Formulary (USP-NF) standards and analytical methods. Taught by USP's subject matter experts, these PE courses are held throughout the year in India. More than 1000 attendees in India have participated in the PE courses to date. USP-India has also conducted a workshop for analysts of drug laboratories from the Network of Official Medicines Control Laboratories (NOMCOL) of South East Asia countries. USP launched the NOMCOL for Asia and the Pacific (NOMCOL-Asia Pacific) to promote cooperation in quality control expertise and increase exchange of technical skills among all laboratories in the regions. Dr Surendranath concluded, "Today, we are here together with a single common goal: to provide patients with medicines that are not only effective but also consistently safe. USP-India is committed to this endeavor and will work in every possible capacity to ensure India's drugs meet the highest global standards of quality and safety." ]]> <![CDATA[Hep B therapeutics market to grow slowly to $3 bn by 2024]]> https://biospectrumindia.com/features/95/8015/hep-b-therapeutics-market-to-grow-slowly-to-3-bn-by-2024.html https://biospectrumindia.com/features/95/8015/hep-b-therapeutics-market-to-grow-slowly-to-3-bn-by-2024.html Wed, 17 Feb 2016 13:08:46 +0530 The global chronic hepatitis B therapeutics market will rise in value from $2.4 billion in 2014 to $3 billion by 2024, representing a modest Compound Annual Growth Rate (CAGR) of 2.4%, says research and consulting firm GlobalData. According to the company's latest report, this expansion, which will occur over the eight major markets (8MM) of the US, France, Germany, Italy, Spain, the UK, Japan, and China, will be slight due to the patent expiration of all existing branded drugs in the chronic hepatitis B therapeutics space during the forecast period, and continued low diagnosis and treatment rates of the disease. Dr Daian Cheng, GlobalData's Analyst covering Infectious Diseases, says: "Low diagnosis rates for hepatitis B are self-perpetuating, as they lead to lack of disease awareness and therefore a dearth of people seeking medical advice or appropriate drugs for their condition. In addition, the negative social stigma surrounding hepatitis means that many people are reluctant to get tested. "With regards to marketed drugs, the chronic hepatitis B therapeutics market will experience harsh generic erosion following the expiration of such popular branded drugs as Bristol-Myers Squibb's Baraclude and Gilead Science's Viread." GlobalData anticipates that generic drugs will take up a major slice of the patient share during the forecast period, consequently reducing therapeutic sales and restricting market growth. Despite the fairly stagnant nature of the chronic hepatitis B treatment arena, GlobalData projects there will be new product launches which will address some key unmet needs. Dr Cheng explains: "Three novel adjunct therapeutic agents are anticipated to enter the market in the 8MM over the forecast period, namely ARC-520, GS-9620, and GS-4774. These drugs have the potential to fulfill the current unmet needs of a very low rate of disease remission and long treatment duration for most patients. "However, substantial unmet needs will endure, particularly as a cure for the disease is yet to be found. Furthermore, there is much room for improvement in achieving the long-term immunological cure for chronic hepatitis B in treatment-indicated patients, as well as for those who currently have no effective treatments available to them, largely due to the clinical limitations of licensed drugs." GlobalData believes that, of the promising drugs in clinical development, ARC-520 will have the greatest impact on the hepatitis B treatment space during the forecast period, with peak-year sales of over $630 million in 2024. ]]> <![CDATA[Glenmark gets tentative ANDA approval for new generic]]> https://biospectrumindia.com/news/95/7063/glenmark-gets-tentative-anda-approval-for-new-generic.html https://biospectrumindia.com/news/95/7063/glenmark-gets-tentative-anda-approval-for-new-generic.html Wed, 17 Feb 2016 12:16:18 +0530 Glenmark Pharmaceuticals USA (Glenmark) has been granted tentative approval by the United States Food and Drug Administration (US FDA) for its Azelaic Acid Gel, 15 percent, the generic version of Finacea Topical Gel, 15 percent of Bayer Healthcare. Glenmark will market this product upon receiving final approval of its Azelaic Acid Gel, 15 percent ANDA. The patent listed in the Orange Book for Finacea Topical Gel, 15 percent is scheduled to expire on November 18, 2018. According to IMS Health sales data for the 12 month period ending December 2015, the Finacea market achieved annual sales of approximately $128.0 million. Glenmark's current portfolio consists of 106 products authorized for distribution in the US marketplace and 62 ANDA's pending approval with the USFDA. ]]> <![CDATA[Merck's Zepatier may threaten Gilead's Harvoni's dominance in Hep C market]]> https://biospectrumindia.com/features/95/8032/mercks-zepatier-may-threaten-gileads-harvonis-dominance-in-hep-c-market.html https://biospectrumindia.com/features/95/8032/mercks-zepatier-may-threaten-gileads-harvonis-dominance-in-hep-c-market.html Tue, 16 Feb 2016 14:24:41 +0530 The introduction of Merck and Co.'s recently-approved drug Zepatier (elbasvir/grazoprevir) to the hepatitis C treatment space will shake up a market long-dominated by Gilead. The combination of Zepatier's excellent clinical profile and highly competitive pricing will play a major role in encouraging its uptake, says an analyst with research and consulting firm GlobalData. Clinical trial data have shown that Zepatier, which was approved in the US on January 28, 2016 for the treatment of hepatitis C virus genotypes 1 and 4, has a similar efficacy and safety profile to Harvoni. The latter has been one of the most profitable drugs in the hepatitis C market by virtue of its efficacy, safety and convenience of use. Since its approval in October 2014, Harvoni generated impressive sales of over $12 billion in the US alone by the end of 2015. However, Dr Daian Cheng, GlobalData's Analyst covering Infectious Diseases, states that now Zepatier has been approved, it will threaten Harvoni's leading commercial position for patients infected with hepatitis C virus genotypes 1 and 4. Dr Cheng comments: "Despite differences in small patient populations, such as those with end-stage renal or liver diseases, Zepatier is highly comparable to Harvoni in clinical performance, as well as dosing convenience. "Thus, the main reason it poses such a threat to Harvoni is its lower cost. Merck has listed Zepatier at a price over 40% lower than that of Harvoni, which should help the company gain patient share for this late-to-market product." As well as challenging Harvoni's lead in the hepatitis C market, Zepatier will affect other drugs similarly priced to Harvoni, and offer solid clinical profiles, such as Gilead's Sovaldi, and AbbVie's Viekira Pak. Dr Cheng explains: "Zepatier will quickly carve out a solid niche in the hepatitis C market due to the way in which it marries brilliant product performance in its efficacy, safety, and cost. However, the response of competitors in price negotiation with payers, especially Gilead, will impact the extent of Zepatier's market penetration. "In a bigger picture, Gilead's products are already covering all hepatitis C genotypes, and the company expects its pan-genotypic, fixed-dose combination of velpatasvir/sofosbuvir to be approved in June this year. Harvoni is also indicated for patients with genotypes 5 and 6 in the US. "In addition, treatment for patients with hepatitis C still presents many other opportunities, especially efficacy improvement in niche, traditionally difficult-to-treat patient populations and those with treatment durations shorter than 12 weeks." The analyst concludes that the market entry of Zepatier will very likely bring about substantial changes in patient share and/or therapy costs in the hepatitis C market, as additional treatment choice will intensify competition. ]]> <![CDATA[Merck, Sun Pharma dissolve partnership ]]> https://biospectrumindia.com/news/95/8305/merck-sun-pharma-dissolve-partnership-.html https://biospectrumindia.com/news/95/8305/merck-sun-pharma-dissolve-partnership-.html Tue, 16 Feb 2016 11:03:46 +0530 Merck & Co and Sun Pharmaceutical have agreed to terminate a joint venture set up in 2011 to develop and market branded generic drugs in emerging markets outside India. "The company has wind down/terminated the collaboration established in 2011 between affiliates of Merck Sharp and Dohme and Sun Pharmaceutical Industries to develop and commercialize novel formulations and combinations of medicines for emerging markets," said Sun Pharma, in a filing to BSE. In 2011, Merck & Co and Sun Pharmaceutical announced the creation of a joint venture to develop, manufacture and commercialize new combinations and formulations of innovative, branded generics in the emerging markets. Reportedly, the two companies has decided to wind down the venture "due to changes in the strategic priorities of both the parent companies." ]]> <![CDATA['Breast cancer market will rise to $3.4 billion by 2021']]> https://biospectrumindia.com/news/95/8346/breast-cancer-market-will-rise-to-3-4-billion-by-2021.html https://biospectrumindia.com/news/95/8346/breast-cancer-market-will-rise-to-3-4-billion-by-2021.html Tue, 16 Feb 2016 10:47:19 +0530 The Asia-Pacific (APAC) breast cancer market is set to experience considerable expansion from $1.9 billion in 2014 to $3.4 billion by 2021, at a robust Compound Annual Growth Rate (CAGR) of 8.5 percent, according to business intelligence provider GBI Research. The company's latest report states that such growth, which will occur across the APAC regions of India, China, Australia, and Japan, will be driven by aging populations, changing lifestyle habits, improved survival rates, and a number of new approvals for drugs that are expected to supplement current market leaders. Ms Deekshita Allavarapu, Analyst for GBI Research, explains: "It is anticipated that popular drugs, such as Afinitor and Herceptin, will be used in conjunction with several promising breast cancer pipeline treatments. These include abemaciclib, buparlisib, LEE 011, olaparib, and Neuvax, all of which are forecast to be approved by 2021 and have shown significant clinical benefit in trials." She added, "Such therapies are on the rise due to their increased use in conjunction with chemotherapy. In addition, the strong efficacy profile of targeted therapies has resulted in favourable reimbursement and increased uptake in Japan and Australia. This is despite the drugs' premium pricing, which reflects the cost associated with their development and the significant therapeutic benefit offered." However, the analyst notes that in India and China, even after premium targeted treatments become available, only patients in the richer territories will be given these drugs, as patients in the poorer districts will not be able to afford them due to a lack of social insurance and inadequately publicly subsidized services. GBI Research also states that applying for reimbursement for oncology drugs in Australia is becoming more difficult due to a time-consuming and complex regulatory and reimbursement process prior to access, which causes a substantial delay in patient access. "These factors limit the uptake of premium-priced therapies, which somewhat restricts overall breast cancer market growth. Nonetheless, the sheer size of the APAC populations means that, even if a relatively small percentage of patients are eligible for treatment, there will be high levels of revenue," Ms Deekshita concluded. ]]> <![CDATA[Cloud computing to drive paradigm shift in Life Sciences]]> https://biospectrumindia.com/news/95/8122/cloud-computing-to-drive-paradigm-shift-in-life-sciences.html https://biospectrumindia.com/news/95/8122/cloud-computing-to-drive-paradigm-shift-in-life-sciences.html Mon, 15 Feb 2016 15:16:25 +0530 The centre will provide expertise in cloud computing technologies and specific platforms including advanced Java, Spring, .NET, Python and statistical programming frameworks. Currently the facility employs more than 250 professionals including software engineers from prestigious institutions and scientists with doctoral degrees. This team is now building next-generation software, acting as an extension to Thermo Fisher's global software R&D teams. The software centre of excellence is Thermo Fisher's first such facility globally. According to the company's press release, cloud computing has the potential to significantly change lab workflows, and facilitate access to powerful data analysis techniques. Mr Mark Field, VP & CTO, Thermo Fisher, who was in India on the occasion, told BioSpectrum, "The plan of erecting the centre has been realized after three years. Cloud computing and Internet of Things (IoT) are causing incredible disruptions across the world. The former has already made a stand in India. I have been in the software industry for 20 years, and India stands at the very forefront in making software and delivering the capabilities to the world. Software is a global phenomenon." Mr Amit Chopra, MD, VP/GM, Thermo Fisher Scientific India, added, "Indian scientists are adopting cloud computing technology, and the adoption rate is going to pick up rapidly. This technology enables scientists to leap forward in pioneering developments and be at the forefront." As a result of using cloud technology, something such as when a powerful genetic analysis software is released, it can immediately be deployed in the cloud, enabling scientific communities around the world to quickly and easily access the new capabilities. Mr Field added, "We have hundreds of users of this technology in India -- from prestigious institutes to commercial organizations -- and they are willing to experiment and play around a little bit before engaging in it fully. Cloud-based computing solutions have already been deployed in the US and Europe on a massive scale. This trend will soon catch up in India, and we are already seeing it coming." Cloud computing in the Life Sciences space is expected to make labs more productive and collaborative. "In the next 5 years, the cloud will become an innovation platform, much like the Internet. In the future, many incredible innovations and impossible things are going to come out of cloud usage," opined Mr Field. Through the cloud, thousands of labs and scientists are expected to get connected and act collaboratively, bringing in amazing capabilities and creating major paradigm shift in the Life Sciences space. "The cloud," Mr Chopra noted, "will change how scientists conduct research. We are providing them the platform to leverage and drive faster research solutions." According to Mr Field, it is way too early to predict the market size for cloud technologies. He said, "As scientific instruments become more and more sophisticated, the amount of data these instruments produce will far exceed the analytical capabilities or labs around the world. And scientists alone will not be able to manage all this data." Mr Chopra explained with an example how the cloud can be the point of origin for futuristic innovations. "Traditional fast-moving consumer goods (FMCG) and retail industries are being transformed by emerging ecommerce companies who have created entirely new business models. This is exactly what we are trying to do in the cloud space. In the next 10 or 15 years, we will see a radically transformed ecosystem in Science. The Internet, for example, transformed online education, opening up online classrooms, with world-class universities offering their programs to hundreds and thousands of students. Now we can envision the possibilities in scientific innovations that cloud computing can provide to Science," he said. ]]> <![CDATA[Biocon gets its first generic formulation approval in EU]]> https://biospectrumindia.com/news/95/8101/biocon-gets-its-first-generic-formulation-approval-in-eu.html https://biospectrumindia.com/news/95/8101/biocon-gets-its-first-generic-formulation-approval-in-eu.html Mon, 15 Feb 2016 11:50:54 +0530 Biocon Ltd., Asia's premier biopharmaceuticals company, announced today that it has received European approvals for its Rosuvastatin Calcium 5 mg, 10 mg, 20 mg and 40 mg tablets, a generic equivalent of Crestor tablets, indicated for hyperlipidemia or mixed dyslipidemia. This first generic formulations approval in the regulated markets marks an important milestone in Biocon's small molecules strategy of forward integration from APIs to finished dosages. The approval for Rosuvastatin Calcium, through decentralized procedure will open the doors for Biocon to over 15 European countries and will enable the company to address $1.2 billion opportunity, starting FY17. Biocon was the first generic company to receive a Certificate of Suitability (CEP) for Rosuvastatin Calcium API from the European Directorate for the Quality of Medicines (EDQM). CEP certification indicates that an API is suitable for use in medicinal products in the EU. Biocon Chairperson & Managing Director Kiran Mazumdar-Shaw said: "This is indeed a proud moment for Biocon's Small Molecules business. This approval paves the way for Biocon to launch Rosuvastatin Calcium tablets in several European countries. We plan to collaborate with regional partners in the near term to provide access to this affordable generic and thus help patients and governments to bring down their healthcare spends." Dr. Arun Chandavarkar, CEO and Joint Managing Director, Biocon said: "The European approval for Biocon's generic version of Rosuvastatin Calcium underscores Biocon's unique strengths in the chronic therapies space and our compliance with global standards that enable us to achieve the highest quality standards for all our products. It augurs well for this nascent business, which will be one of our growth drivers in the coming years." Biocon aims to rev up its generic formulations business with a target of 20-25 filings over the next few years. Its new potent oral solid dosage formulations facility coming up in Bengaluru will enable this business expansion. The company is also working on dossiers to introduce these formulations in emerging markets where regulatory clearances are primarily based on approvals given by regulators in the US / EU. ]]> <![CDATA[GEAC halt GM mustard cultivation]]> https://biospectrumindia.com/news/95/8398/geac-halt-gm-mustard-cultivation.html https://biospectrumindia.com/news/95/8398/geac-halt-gm-mustard-cultivation.html Mon, 15 Feb 2016 11:44:29 +0530 Genetic Engineering Appraisal Committee (GEAC), the regulatory body for genetically-modified food under the Environment Ministry, had deferred a decision on allowing commercial cultivation of genetically modified (GM) mustard and has asked the developer of the hybrid mustard to provide some more information on bio-safety related data. on Feb 05,2016 GEAC has conducted a meeting. "In today's meeting, we sought more information from those who developed GM mustard (Centre for Genetic Manipulation of Crop Plants, Delhi University) and had applied for permission for commercial cultivation. We will not rush through and will take a decision only after due deliberations," said Mr Prakash Javadekar, Environment Minister, after the meeting. Reportedly, GEAC suggested eight additional bio-informatics tests for inclusion in the seed's biosafety dossier and asked the Centre for Genetic Manipulation of Crop Plants (CGMCP) to prepare a Risk Assessment and Risk Management (RARM) document. It set a timeline of two weeks for submission of the revised biosafety dossier but separately recommended a long winding procedure for further review and consultation on the biosafety data. According to the regulator, the revised dossier received from the applicant would be considered by the Sub-Committee and a Biosafety RARM report would be prepared for consideration of the GEAC. Subsequent to the review, and if the biosafety dossier is found to be complete in all respects, the GEAC has recommended that both dossier and RARM report - minus certain confidential segments - be put out in the public domain for comments. However, no information would be posted while the review is still under progress. As per a note from the Environment Ministry, "A detailed response to the comments received would be prepared and considered before a final decision is taken by the GEAC." ]]> <![CDATA[The New Age Armageddon: War on Superbugs]]> https://biospectrumindia.com/news/95/6940/the-new-age-armageddon-war-on-superbugs.html https://biospectrumindia.com/news/95/6940/the-new-age-armageddon-war-on-superbugs.html Fri, 12 Feb 2016 14:22:00 +0530 Common diseases and infections, once curable, may turn out to be incurable again with the emergence of antibiotic resistance in bacteria, threatening the global health security. Many countries and global health organizations are adding this new age menace to their emergency list. Pharmaceutical companies around the world have excelled in the mass production of antibiotics, which in turn has led to the misuse and over-usage of antibiotics, creating bacteria that are totally refractory to the action of all antibiotics. This antibiotic resistance has created an urgent medical need for discovering new drugs to combat the increasing loss of lives due to hospital-acquired infections, urinary tract infections, pneumonia, and bloodstream infections, among others. GangaGen Biotechnologies, a Bangalore-based Biotechnology R&D company, is focusing on developing new and novel therapeutic agents derived from Bacteriophages to control bacterial pathogens resistant to antibiotic therapy. Phage-based therapeutics are novel, first-in-class molecules that have potent activity against bacterial pathogens. About one hundred years ago, French-Canadian microbiologist Dr FÃ©lix d'Herelle discovered the Bacteriophage, a bacterial virus, at the Pasteur Institute in Paris, France. A Bacteriophage is a virus active against specific bacteria. It infects the bacteria, multiplies within and ultimately kills them. The progeny Bacteriophages emerge from the lysed bacterial cells, then pursue and kill neighboring bacterial cells of the same kind. During his experiments, Dr d'Herelle discovered the benefits of treatment using Bacteriophages because of the powerful and specific antibacterial activity of the phages. He conceived the concept of 'Phage Therapy', a therapeutic process of using Bacteriophages' selectivity for destroying pathogenic bacteria, but remaining neutral to human cells. "In the next 10 years, we may not have any new antibiotics. We should look at Phages as a possibility for combating drug resistance. This approach marks a paradigm shift in antibacterial therapeutics, and opens up possibilities of developing novel pathogen-specific therapies, which will also be consistent with the aim of limiting the spread of drug resistance," says Prof J Ramachandran, Chairman, GangaGen. In Tbilisi, Georgia, for example, Phage Therapy is routinely practiced even today as one of the major ways of treating infections. Phage therapy has the potential to deal 'smartly' with infections, but unfortunately this mode of treatment disappeared from the radar as pharma companies found antibiotics much easier to manufacture. Back in 2000, when Phage Therapy was presented to regulatory agencies, it was viewed as a regulatory risk because of bringing foreign DNA into the human body, and because of the Phage's ability to amplify. Thus, regulatory bodies were less keen to focus on Bacteriophages as a therapy. Taking a cue from the natural mode of action of the Bacteriophages for invading their host bacteria, scientists at GangaGen have designed a unique protein molecule, which is a hybrid phage protein combining the properties of selective binding, and the ability to punch holes in the bacterial cell. The engineered protein, P128 (StaphTAME), exerts its killing activity from outside the cell through binding to specific chemical structures on the Staph cell wall, unlike conventional antibiotics, which can kill only after entering the bacterial cell. Dr T S Balganesh, President, GanGagen Biotechnologies, avers that this unique property of P128 along with its rapid action also significantly reduces the rate of development of resistance. The acronym 'TAME' used by the company for these 'Tail Associated Muralytic Enzymes' is apt, as the protein can 'tame' superbugs. Antibiotics tend to kill both the disease-causing bacteria and the untargeted, often helpful, microflora in the body. The P128 is a recombinant protein developed for the prevention and treatment of Staphylococcal infections, including infection with methicillin-resistant S. aureus (MRSA), and does not act on other bacterial species which forms a part of the normal flora of the human body. Additionally, P128 has potent activity against S.aureus in biofilms, which are resilient to most antimicrobial agents. From bench-to-bedside, the R&D for this patented P128 was done in Bangalore, at a fraction of the cost if it were done in the US. The product is the first TAME-based protein to enter clinical development and currently has the following development portfolio: ï‚§ First-in-Class for eradicating Staphylococcus aureus from the anterior nares of dialysis patients. (Phase 1/2a study completed in Singapore) ï‚§ First-in-Class for treating Staphylococcus spp infections of 'venous leg ulcers'. (Phase 1/2a study for determining safety and efficacy scheduled in 2016 in the US) ï‚§ First-in-Class for treating Staphylococcus bacteremia in combination with Standard of Care (SOC) antibiotics. (The protein is in late pre-clinical development for the indication, with initial clinical studies planned for 2017) ]]> <![CDATA[Invictus Oncology raises funds from Ratan Tata ]]> https://biospectrumindia.com/news/95/7646/invictus-oncology-raises-funds-from-ratan-tata-.html https://biospectrumindia.com/news/95/7646/invictus-oncology-raises-funds-from-ratan-tata-.html Fri, 12 Feb 2016 11:45:02 +0530 Chairman Emeritus of Tata Sons Limited, Ratan N Tata has invested in Delhi-based Invictus Oncology Private Limited, an innovation-driven oncology company developing next generation cancer therapeutics that are more effective and less toxic. The investment in the company comes as part of the first close of Invictus's Series A financing round, joining existing investors Navam Capital and Aarin Capital. Invictus Oncology employs a supra-molecular technology platform to design anti-cancer drugs that home into the tumor and modulate the tumor immune response. Its lead molecule, IO 125, has already been validated in multiple cancer models, and is poised to enter IND-enabling studies to obtain US Food and Drug Administration (US FDA) approval for initiating clinical studies. Invictus Oncology has already developed a deep pipeline of molecules, which address a $20 billion market opportunity in the oncology space. Recent acquisitions and partnership deals in this area have taken place at multi-billion dollar valuations. "I have admired Ratan Tata's insights and astute assessment of technology for decades now, so I am thrilled he has invested in Invictus, which is not just developing ground-breaking innovations for cancer treatment, but is also among the very first startups based out of India to tread the path of novel discovery and biotech innovation," said Invictus Co-Founder, Dr Raghunath A Mashelkar. "Mr Tata's investment is a strong affirmation of the quality of the technology that Invictus has developed. We are getting excellent traction from investors, both from India and outside," said Dr Shiladitya Sengupta, Co-Founder of Invictus and Assistant Professor of Medicine at Harvard Medical School. The funds raised will be used to advance Invictus' lead molecule for completion of Phase I clinical studies, and to file a second Investigational New Drug (IND) application; milestones which translate into substantial value inflections for Invictus Oncology over the next 12-18 months. ]]> <![CDATA[Will Healthcare find focus in Budget 2016?]]> https://biospectrumindia.com/views/95/7649/will-healthcare-find-focus-in-budget-2016.html https://biospectrumindia.com/views/95/7649/will-healthcare-find-focus-in-budget-2016.html Fri, 12 Feb 2016 11:41:40 +0530 A robust healthcare system drives GDP growth, productivity and employment generation. The sector has been seeking the FM's attention for the last few years to enable it to fulfil both its social and economic agenda. The budget should provide an increased allocation for healthcare towards a direction of 2.5 - 3 percent of GDP over the short term beginning with a two percent provision this year. The allocation of Rs 331.5 billion in the last fiscal for healthcare was a decline from the previous year. For a sector which is the 5th largest employer in the country there is a significant opportunity to give it a much needed fillip by supporting its infrastructure expansion and expanding the base of medical education in the country. Healthcare infrastructure should be included in Tax free infrastructure bonds. The budget should also focus on raising tax exemption for preventive health and create a national agenda on combating diabetes which already effects 65 million Indians. Hopefully the budget will address all the incentives announced in the Start Up India policy which will provide the much needed opportunity for innovation and entrepreneurship in the healthcare delivery and medtech sector. ]]> <![CDATA[Indian Institute of Science, Bangalore wins the State Bio Quiz 2016]]> https://biospectrumindia.com/news/95/7635/indian-institute-of-science-bangalore-wins-the-state-bio-quiz-2016.html https://biospectrumindia.com/news/95/7635/indian-institute-of-science-bangalore-wins-the-state-bio-quiz-2016.html Fri, 12 Feb 2016 09:52:54 +0530 The 8th Edition of annual Bio Quiz conducted along with Bangalore INDIA BIO witnessed the keen contest amongst the finalist from IISc, Bangalore; UAS, Dharwad; St. Aloysius Managalore; College of Agriculture, Vijaypur; National College of Pharmacy, Shimoga ; SJCE, Mysore. Preliminaries of state level 'BioQuiz 2016' was conducted across Karnataka where-in over 3000 students participated. The results of the quiz are as below:â€¢ Winning Team - Subhajit Dasgupta and Siddarth Kankaria, IISc, Bangaloreâ€¢ 1st Runners Up - Akarsh R and Basangowda Gopal, University of Agriculture Sciences, Dharwadâ€¢ 2nd Runners Up - Megan Dsouza and Ninaad Lasrado, St. Aloysius, Mangaloreâ€¢ 3rd Runners Up - Suraj Melavanki and Sachin Wali, College of Agriculture, Vijaypurâ€¢ 4th Runner Up - Chetan N and Srinidhi B.R., National College of Pharmacy ]]> <![CDATA[Biotechnology leaders forecast the trends in Biotech at Bangalore INDIA BIO 2016]]> https://biospectrumindia.com/news/95/8286/biotechnology-leaders-forecast-the-trends-in-biotech-at-bangalore-india-bio-2016.html https://biospectrumindia.com/news/95/8286/biotechnology-leaders-forecast-the-trends-in-biotech-at-bangalore-india-bio-2016.html Fri, 12 Feb 2016 09:50:09 +0530 The 16th edition of the Bangalore INDIA BIO concluded after three eventful days. The event was organized by the Department of Information Technology, Biotechnology and Science & Technology, Government of Karnataka, Vision Group on Biotechnology and Event Partner MM Activ Sci-Tech Communications. The sessions in the conference most aptly reflected the overarching theme of WHAT'S TRENDING IN BIOTECH INDIA, with special focus on Internet of things and Healthcare, Regenerative Medicine, Rare Diseases and Orphan Drugs, Proteomics and Bioinformatics, Synthetic Biology, Precision Medicine & Oncology. The Agri-Biotech day in the conference focused on Agri-Biotechnology for Feed, Food, Fuel and Fibre Security and the highlight was a lively interaction of Experts and farmers from various parts of Karnataka. Besides industry stalwarts and research heads, the conference saw a bevy of Start-Ups who presented their ideas and products, as part of the Bio Invest & Bio Accelerate Program. The BEST-India (Biotechnology Entrepreneurship Student Teams) start-ups incubated at IIT-Kharagpur, Defence and Food Research Laboratory, Mysore, Institute of Chemical Technology, Mumbai, etc. presented their breakthrough ideas. The Event was graced by National and International personalities from Government and Industry viz. Dr. Harsh Vardhan, Hon'ble Minister for Science and Technology and Earth Sciences, Government of India; Ms. Matia Chouwdhury, Hon'ble Minister of Agriculture, Peoples Republic of Bangladesh; Dr. C. Randal Mills, President & CEO, California Institute for Regenerative Medicine (CIRM), Mr. Dominic McAllister, British Deputy High Commissioner, Bengaluru ; Prof. K. VijayRaghavan Secretary, Department of Biotechnology, Ministry of Science & Technology, Government of India; Dr. Kiran Mazumdar Shaw, Chairperson, Karnataka Vision Group on Biotechnology, CMD, Biocon Limited; Dr. Carlos Barreiro, Head of Industrial Process Area, INBIOTEC, Spain; Ms. Heajin Jung, President, Smart Avenue, Seoul, Korea; Dr. P.M. Murali, President ABLE; Dr. Ajit Sapre, Group President, Research and Technology, Reliance Industries; Dr. Paresh Varma, President, Bioseed South East Asia & Research Director - BRI; Dr. C.D. Mayee, Chairman AFC Ltd, Mumbai. Also present from Government of Karnataka were personalities like Mr. K.J. George, Hon'ble Minister for Bangalore Development and Town Planning, Government of Karnataka; Mr. Krishna Byre Gowda, Hon'ble Minister for Agriculture, Government of Karnataka; Mr. Roshan Baig, Minister for Infrastructure Development, Information and Haj, Government of Karnataka; Ms. Latha Krishna Rao, IAS, Additional Chief Secretary and Development Commissioner, Government of Karnataka; Ms. V. Manjula, IAS, Principal Secretary, Department of IT, BT, S&T, Government of Karnataka. The Bio Excellence Awards were presented at a glittering Ceremony. The process of selection of these awards was conducted by Association of Biotechnology-led Enterprises (ABLE). The list of awards presented for respective categories is as follows: Bio Excellence Awards were given to:â€¢ Bio Pharma & Healthcare - Bioconâ€¢ BioAgri - Ajeet Seedsâ€¢ BioServices - Ecron Acunovaâ€¢ BioIndustrial - Novozymes South Asia Pvt. Ltd.â€¢ BioInformatics & Systems Biology - Mitra Biotech Emerging Company of the Year Awards were given to:â€¢ Bio Pharma & Healthcare - Pandorum Technologies â€¢ BioAgri - Criyagen Agri & Biotech Pvt Ltdâ€¢ BioServices - Affigenix Biosolutionsâ€¢ BioIndustrial -Cellzyme Biotechâ€¢ BioInformatics & Systems Biology - MedGenome KEY EVENT HIGHLIGHTS â€¢ Consisted of 25 Sessions with 116 Speakers, over 1000 Delegates participated. â€¢ 92 Poster Presenters presented their Research Ideas in Poster Session - Walkway of Discovery. â€¢ About 80 Exhibitors from various verticals of Life Sciences Industry like biopharmaceuticals, bio- suppliers, bio-informatics, bio-medical devices and Start-ups participated in the Exhibition which attracted over 3000 business visitors. â€¢ International representation this year is from over 10 countries with major delegations from UK, Spain, Korea and delegates from leading countries like USA, Canada, Australia, France, Germany, Poland, Belgium, Taiwan, Malaysia â€¢ The event also witnessed participation from various States like Uttar Pradesh, Madhya Pradesh, Gujarat, Andhra Pradesh. â€¢ Bangalore INDIA BIO 2016 facilitated over 300 B2B meetings through the B2B Partnering tool - InterlinX out of which over 60% meetings were between Indian and International Companies ]]> <![CDATA[BD collaborates with Healthcare Sector Skill Council to launch standardized training modules for lab professionals in phlebotomy]]> https://biospectrumindia.com/news/95/8020/bd-collaborates-with-healthcare-sector-skill-council-to-launch-standardized-training-modules-for-lab-professionals-in-phlebotomy.html https://biospectrumindia.com/news/95/8020/bd-collaborates-with-healthcare-sector-skill-council-to-launch-standardized-training-modules-for-lab-professionals-in-phlebotomy.html Thu, 11 Feb 2016 16:44:16 +0530 Aligned with its commitment towards the advancement of preanalytical science that improve patient safety in India, BD (Becton, Dickinson & Co.) and Healthcare Sector Skill Council today signed an agreement to develop co-branded training modules for "Phlebotomy Technician Course''. This initiative will provide training on best practices in Phlebotomy to laboratory professionals in order to improve their employability. The Healthcare Sector Skill Council with support from National Skill Development Corporation (NSDC) is working relentlessly with the industry in skilling healthcare professionals in the allied healthcare space. Availability of skilled healthcare professionals is a big challenge. Training module developed by BD as knowledge partner would be leveraged by candidates enrolled for fresh training as well as RPL (Recognition of prior learning) training for Phlebotomy technician course under ambit of HSSC. Additionally, BD will also train the master trainers who will cascade the training to healthcare professionals and support them in driving best practices in preanalytical processes for accurate and reliable diagnosis. On the occasion, Varun Khanna - Managing Director- BD India & South Asia, said, "At a time when the Skill India Movement is looking at bringing about convergence and focusing on industry linkages, this initiative comes as BD's commitment to enhance the skills of laboratory technicians. It will address the shortage in human resources both in terms of skill and number leading to universal health coverage for all. Through the standardized curriculum in phlebotomy training with HSSC, together we will be able to enhance the clinical practices in creating sustainable improvements in Indian healthcare." Phlebotomy (blood collection) is a major component of preanalytical phase. A laboratory test is no better than the specimen and the specimen no better than the manner in which it was collected. For tests to be accurate, quality specimen is needed i.e. a specimen which accurately reflects the in vivo situation of the patient at the time of collection. Stressing on the need to upgrade skills, Ashish Jain - CEO, Healthcare Sector Skill Council said, "There is immense potential to enhance the skills of laboratory technicians in line with the growing healthcare needs. Keeping in mind the need for phlebotomy by the healthcare sector, HSSC with industry experts has developed the Qualification Pack-National Occupational Standards (QP-NOS) for Phlebotomy technicians that will facilitate plugging the existing skill gap in this area. Today's agreement is a significant step in this direction." Many of the Allied Health Institutes have received an affiliation for different courses from the Health Sector Skills Council (HSSC), which is constituted and supported by National Skills Development Corporation. The aim of the Council is to create a robust and vibrant eco-system for quality vocational education and skill development in Allied Healthcare space in the country. According to a study titled 'From Paramedics to Allied Health Sciences: landscaping the journey and way forward' undertaken by the Public Health Foundation of India (PHFI), India faces an acute shortage of over 64 lakh skilled human resource in the health sector. The shortfall has resulted in the uneven distribution of all cadres of health workers, medical and nursing colleges and has led to an imbalance both in the capacity and in quality of education and training, leading to poor health outcomes. There is ample international evidence suggesting that empowered allied health professionals (or paramedics, as they are known internationally) can be the leaders of change, playing critical roles in improving the reach of health services in underserved areas. ]]> <![CDATA[Leading Cardiologists launch 'Indian Consensus Guidance on Stroke Prevention in Atrial Fibrillation']]> https://biospectrumindia.com/news/95/7614/leading-cardiologists-launch-indian-consensus-guidance-on-stroke-prevention-in-atrial-fibrillation.html https://biospectrumindia.com/news/95/7614/leading-cardiologists-launch-indian-consensus-guidance-on-stroke-prevention-in-atrial-fibrillation.html Thu, 11 Feb 2016 16:24:13 +0530 Understanding the need to address challenges faced by Indian doctors in Stroke Prevention, leading Cardiologists across India formulated and published 'Indian Consensus Guidance on Stroke Prevention in Atrial Fibrillation' in association with the SPAF Academy India Experts (Stroke Prevention in Atrial Fibrillation). The consensus is published in the December 2015 edition of 'Indian Heart Journal'. Stroke or a brain attack is said to be the second largest cause of death in India. About If not managed appropriately 1 in 20 AF patients may develop stroke every year. Atrial Fibrillation an irregular heart rhythm (arrhythmia) of up to 300 beats/min (4 times than normal), is a high risk factor for Stroke. Most common risk factors for Atrial Fibrillation include old age (>60 years), high blood pressure, heart failure, heart disorders, prior history of open heart surgery, thyroid disorder, diabetes, chronic lung disease, excessive alcohol intake etc. Atrial Fibrillation can cause a blood clot in the heart which may travel to a person's brain, preventing normal blood flow and hence resulting in Stroke. Immediate and proper management of Stroke is required to prevent death or paralysis. However, there are challenges in management of Stroke prevention in patients with Atrial Fibrillation, the most frequent being: â€¢Low diagnosis rate of Atrial Fibrillation, an indication of impending Stroke attackâ€¢Management of Acute Coronary Syndrome(e.g. heart attack) â€¢Understand the differences in response of Asian and Western patients to blood thinners â€¢Matching the right drug to right patients from the new class of available blood thinners Highlighting the need for Guidelines to address these challenges, Dr Sundeep Mishra, professor and consultant cardiologist, AIIMS, New Delhi and Editor of Indian Heart Journal said, "A Stroke incidence due to Atrial Fibrillation can be prevented if the symptoms are recognized and managed properly. Diagnosing Atrial Fibrillation and an impending stroke is not just a challenge in India but the world over, as this rhythm disorder of the heart is episodic in nature and remains silent for many years. In fact, for many patients, stroke could be the first presentation. Therefore, there was a need to develop guidelines to advice doctors how to manage Stroke in patients with Atrial Fibrillation." Explaining the formulation and essence of the Guidelines, Dr Jamshed Dalal, director, Center for Cardiac Sciences, Kokilaben Dhirubhai Ambani Hospital, Mumbai said, "The Indian Consensus Guidance will help doctors with diagnosis and management procedures to prevent stroke in patients with Atrial Fibrillation. It provides recommendations for rational use of newer class of oral blood thinners (NOACs- Non-vitamin K antagonists) in Indian patients while providing evidence on NOACs in Asians including Indians. It gives a risk stratification of Stroke and Bleeding" The 'Indian Consensus Guidance for Stroke Prevention in Atrial Fibrillation' was framed by 14 leading Indian Cardiologists, hematologists and SPAF Academy India (subset of SPAF Academy Global) which is a 35 member steering committee of key Cardiologists, Neurologists, Haematologists across India. ]]> <![CDATA[Mylan to acquire Meda for $9.9 billion]]> https://biospectrumindia.com/news/95/7607/mylan-to-acquire-meda-for-9-9-billion.html https://biospectrumindia.com/news/95/7607/mylan-to-acquire-meda-for-9-9-billion.html Thu, 11 Feb 2016 16:16:32 +0530 Mylan NV has announced a public offer to the shareholders of Meda, a Sweden based specialty pharma company, to transfer all of their shares in Meda to Mylan for a consideration consisting of a combination of cash and Mylan Shares. The total Offer consideration consists of a combination of cash and Mylan ordinary shares ("Mylan Shares") with a value at announcement of SEK 165 per Meda share. The total value of the Offer for all Meda shares, including Meda net debt, is approximately SEK 83.6 billion or $9.9 billion. The Offer has been unanimously approved by Mylan's board of directors and unanimously recommended by Meda's board of directors. Meda's two largest shareholders, representing in the aggregate approximately 30 percent of Meda's outstanding shares, have undertaken to accept the Offer, subject to certain conditions. The Offer is subject to the satisfaction of a number of customary conditions, including clearance from relevant competition authorities, and is expected to be completed by the end of the third quarter of 2016. The combination of Mylan and Meda will create a diversified global pharmaceutical leader with an expansive portfolio of branded and generic medicines and a strong and growing portfolio of over-the-counter (OTC) products. The combined company will have a balanced global footprint with significant scale in key geographic markets, particularly the US and Europe. The acquisition of Meda also provides Mylan with entry into a number of new and attractive emerging markets, including China, Southeast Asia, Russia, the Middle East and Mexico, complemented by Mylan's presence in India, Brazil and Africa. Mylan and Meda have a highly complementary therapeutic presence, which will create a leading global player in respiratory / allergy, and achieve critical mass in dermatology and pain, offering greater opportunities for growth in these categories. Mylan executive chairman, Robert Coury, commented, "Our acquisition of Meda will allow us to accelerate and deliver on the clear and compelling vision and strategy we have continuously communicated to our shareholders, and once again deliver a transaction that will create significant value. We believe Mylan is uniquely positioned in the global pharmaceutical space today, with very strong fundamentals and a long and successful track record of executing on all previous acquisitions and organic opportunities. We structured this transaction in a way that optimizes our balance sheet and still leaves us ample financial flexibility to continue to complement our business with additional attractive opportunities. "Over the course of more than 10 years, I have been privileged to first be a part of, and more recently to lead, Meda. I believe that Meda is an exceptional organization that has continued to go from strength to strength and has a strong and well-defined growth profile going forward. The proposed transaction with Mylan is very compelling from a strategic standpoint and I believe Meda will be a strong partner for Mylan and will bring additional value to Mylan. The two businesses are highly complementary, and the combined business will benefit from strong therapeutic presence in respiratory/allergy, dermatology and pain and inflammation, as well as enhancing our mass in Europe and US presence," said chief executive officer of Meda, Dr JÃ¶rg-Thomas Dierks. ]]> <![CDATA[BioAsia 2016 hosts startup showcase program]]> https://biospectrumindia.com/news/95/7602/bioasia-2016-hosts-startup-showcase-program.html https://biospectrumindia.com/news/95/7602/bioasia-2016-hosts-startup-showcase-program.html Thu, 11 Feb 2016 10:21:00 +0530 The 13th edition of BioAsia, Asia's largest Biotechnology and Life-sciences forum conducted the Startup Showcase program on the concluding day of the 3 day event. Jay Krishnan CEO T- Hub spoke about Entrepreneurship, the need to support and encourage startups in India and the initiatives at T-Hub. T-Hub - the largest incubator in the country announced the launch of its first accelerator in the area of Health Tech. To be named as - T-Hub Health Tech Innovation Accelerator, is in partnership with Merck and Microsoft Ventures. The accelerator will comprise of: A structured and steady execution plan, A growth plan based on experimentation and metrics and A well prioritized product plan. The startups operating from the accelerator will further receive mentorship from domain experts and will be connected to a platform to receive investment from institutional ventures. Dr. Premanandini Satgunam of LVPEI was awarded The BioAsia 2016 Innovation Award. She also received a grant of Rs 60,000; at BioAsia 2016 Startup Showcase program. The panelists during the startup showcase included: Nobel Laureate Prof. Ada Yonath, Weismann Institute, Israel, Mr. Vipin Antony, Mr. Suresh Challa President TiE Hyderabad, Mr. Shakthi Nagappan CEO BioAsia and Mr. Ramesh Loganathan, VP Products & MD Progress India and President HYSEA. The startups which showcased at BioAsia 2016 were selected from the 150 applications received for the showcase program from the healthcare and innovation sector. The jury that included the startups included Mr. Safir Adeni, MD Ineda Ventures, Mr. PS Srikanth, Investment Director, Hyd Angels and many more. BioAsia is born with a vision to enhance, enrich and encourage newer innovations, path-breaking discoveries and effective solutions in the biotechnology industry by offering a vibrant global platform for convergence of the key stakeholders - Biotech & Biopharma Companies, research institutions, academia, investors, service providers, policy makers, regulators and analysts. ]]> <![CDATA[Day 2 of Bangalore India BIO dominated by sessions on Agribiotechnology]]> https://biospectrumindia.com/news/95/3146/day-2-of-bangalore-india-bio-dominated-by-sessions-on-agribiotechnology.html https://biospectrumindia.com/news/95/3146/day-2-of-bangalore-india-bio-dominated-by-sessions-on-agribiotechnology.html Thu, 11 Feb 2016 10:17:34 +0530 The second day of the 16th edition of Bangalore India BIO was dotted with thought provoking sessions with key influencers from the industry. The day was dedicated to deliberations on Agribiotechnology that explored the nuances of Food, Feed, Fuel & Fiber Security, Biofuels, and included sessions on Biotechnology in healthcare such as Regenerative Medicine, Internet of Things, and Synthetic Biology. The keynote speech during the inaugural was made by the Guest of Honour- Smt. Matia Chowdhury, Hon. Minister of Agriculture, Peoples Republic of Bangladesh and was attended by progressive farmers who travelled to be part of the on-going discussion. Lauding the efforts of the State Government, Smt. Matia Chowdhury iterated that "The Government of Karnataka has played a key role in the development of biotech in the state. In Bangladesh, agriculture plays an important role in minimizing hunger and removing poverty. The lands are sinking at an alarming rate due to urbanization, natural disasters and the huge and increasing population. We have to follow science and technology which will improve standards of living. The opportunities in biotech are enormous and multi-faceted. Bangladesh's growth in biotech is largely based on research and collaborations with a university. The revolution was started with Hybrid and GM varieties of crops. BT brinjal was introduced as pesticides on this crops are found to be more than 100% compared to others. Farmers are self-sufficient and don't rely on seed companies. Biotech ensures food security, health & nutrition, livelihood improvement, conservation of environment and poverty alleviation" She concluded the keynote saying "Last part of the 20th century has seen info technology, communication technology and biotechnology. We will conserve the nature but not be conservative". Chief Guest, Krishna Byre Gowda, Hon'ble Minister of Agriculture for State, Government of Karnataka in his speech said "In the last few years the Government of Karnataka has tied up with consortiums and has also signed MOUs where Karnataka will fund research and development of drought and disease resistant crops. The state is also funding non-GM biotech research on Ragi, jowar, groundnut etc. He emphasized on the need for private and public collaborations for growth and development of biotechnology. Democracy should not be reason for not debating meaningfully on Biotech, rather it should facilitate the debate. ". The dais was also graced by noted dignitaries from the government of Karnataka such as Ms. V. Manjula, IAS, Principal Secretary, Department of Information, Technology, Biotechnology and Science & Technology who spoke about what Karnataka looks forward to in the areas of research and added that the value of research comes through the application and not for the benefit of the researcher. On the occasion Latha Krishnarao, Additional Chief Secretary and Development Commissioner commented saying-"Unless a farmer does not see the whole community accepting a new idea, he will not do it himself. If a crop fails, the farmer will be destroyed as no one takes the responsibility to safeguard the farmer in case an experiment fails. Extensive work on this has to be done by government, agencies, research institutes etc. Are we doing the research on what the farmer wants or just going ahead based on assumptions?" She emphasized that while India is self-sufficient in production of crops, storage and distribution channels have to be improved, in order to ensure equitable distribution and availability. They inaugural dignitaries also included experts in the field of Agribiotechnology such as Dr. Paresh Verma, Managing Director, Research Shriram Bio seeds Genetics India Ltd. and Dr. K. K. Narayanan, Managing Director, Metahelix Life Sciences Ltd. The day was power packed with 3 sessions on Agribiotechnology: 1. Agribiotechnology for Food, Feed, Fuel & Fiber Security, 2. Agribiotechnology - Panel Discussion, 3. Biofuels as a Viable / Feasible alternative in India. Between sessions, the Farmer community attending the session also interacted with government representatives. An HR workshop was also organized by The Biotech Finishing Schools, followed by a Valedictory Function. The session on Bio-healthcare had sessions on 1. Regenerative Medicine, Synthetic Biology and the final session focusing on Internet of Things in Healthcare. The second day of the conference saw a conglomeration of best brains in the industry in both India and abroad. The sessions focused on sharing thoughts, insights, best practices and case studies from across the world. The day ended on a rather high note building just the right kind of ambience for the final day of the conference. ]]> <![CDATA[Alchem launches phytomedicine to combat cough, cold and flu]]> https://biospectrumindia.com/news/95/7346/alchem-launches-phytomedicine-to-combat-cough-cold-and-flu.html https://biospectrumindia.com/news/95/7346/alchem-launches-phytomedicine-to-combat-cough-cold-and-flu.html Wed, 10 Feb 2016 16:37:30 +0530 Alchem International launches the third generation phytomedicine called PhytoRelief-CC to combat symptoms of cough, cold and flu. PhytoRelief-CC comes in the form of chewable sugar-free lozenges which contain concentrated and purified molecular extracts of turmeric (haridra), ginger (zingiber officinale), and pomegranate (dantabija). The synergistic effect of these nature-derived ingredients offers a host of benefits to quickly and naturally cure symptoms of cough, cold and flu. PhytoRelief-CC has very potent anti-viral, anti-bacterial, immune-modulatory, anti-inflammatory, anti-allergic and anti-oxidant properties. It has been developed using AlchemLife's proprietary PhytoplexTM technology based on cutting-edge science to deliver unsurpassed efficacy without any side effects. PhytoplexTM technology is Alchem's proprietary extraction process which isolates active plant molecules in a way that preserves the `natural balance' and 'synergistic effects' present in the original plant material. Raman Mehta, Founder, Alchem International, said, "PhytoRelief-CC provides quick and effective relief naturally, combining the power of traditional medicinal herbs with cutting-edge science and research. We expect a very encouraging response as there is presently no natural offering in the market that is backed by clinically proven results for the prevention and treatment of symptoms of cold, cough and flu." In European clinical studies published in prestigious peer-reviewed international journals like Minerva Gastroenterol Dietol and Minerva Medica, PhytoRelief-CC has proven to be very effective for conditions like cold and flu symptoms, upper respiratory tract infections, and mucosal lesions of the mouth and throat (associated with Bechet's disease). Compared to the placebo, PhytoRelief-CC led to reduction of signs and symptoms of cold and flu within 2weeks, 83 % reduction in bacterial load within 3 days, and effective anti-viral activity against various strains of influenza. Tests have also shown significant improvements in treating disorders of the mouth, throat and upper respiratory tract infections within just 4-5 days. Priced at Rs199 for a strip of 10 lozenges, PhytoRelief-CC will be distributed in phases across the country at all retail and pharmacy outlets. Sudhir Mehra, Senior Vice President, Alchem International, said, "The product will first be made available across North India and subsequently register its presence in other parts of India." ]]> <![CDATA["Collaboration is Cure for Better Global Health Outcomes"]]> https://biospectrumindia.com/news/95/7343/collaboration-is-cure-for-better-global-health-outcomes.html https://biospectrumindia.com/news/95/7343/collaboration-is-cure-for-better-global-health-outcomes.html Wed, 10 Feb 2016 16:31:33 +0530 Healthcare and biotechnology companies should be focused on developing blockbuster drugs that benefit billions of patients, says world-leading healthcare experts, and this can only be done through collaboration and innovation they say. Speaking at the opening day of the Bangalore India Bio, leaders in Life Sciences presented their views at the UK Trade & Investment (UKTI) India Making Tomorrow's Medicine. Speaking at the event, Indian entrepreneur and Chairwoman of India's biggest bio-tech company, Biocon Limited, Dr Kiran Mazumdar Shaw, said in making the Medicines of Tomorrow, the endeavour should be to leverage innovation to develop therapies which are affordable and accessible. "As global priorities shift from providing exclusive and expensive drugs to more affordable drugs to enhance access to greater patient populations, we need to focus on developing blockbuster drugs with a potential to benefit a billion patients," said Ms Shaw. "A developing country like India needs to invest in an affordable innovation model that can help address the burgeoning healthcare challenges of India, where 80 percent of healthcare expenses are borne by the patients, in the absence of a universal healthcare program run by the Government." "The UK, with its ecosystem of research institutes, innovative companies and a large scientific pool, has become an important destination for high-end innovation and research. As large numbers of Indian companies commit themselves to innovation, UK's innovation ecosystem can provide learning opportunities for these companies to develop new competencies through collaborative research and alliances and join hands in their pursuit of addressing unmet medical needs," she said. The UK has the strongest overseas presence with more than 20 companies participating in the 16th edition of Bangalore India Bio.Deputy High Commissioner, Dominic McAllister, said the UK and India have built a legacy of collaboration in life sciences over recent years. "Our role within the British Deputy High Commission in Bengaluru is to not only strengthen existing links, but also to explore new ways of working together. Making Tomorrow's Medicines in India using UK capabilities is aligned to Prime Minister Modi's vision ofMake In India and is an example of GREAT for Collaboration an exciting campaign that inspires new partnerships between the UK and India. The UK has a long track record of cost-effective and compliant medicines manufacturing from leading global companies.India has taken over from Italy as one of the leading supplier of manufacturing supply chains and is ideally positioned to be the hub of activity around Making Tomorrow's Medicine. Jon Mowles, UKTI Life Science Sector Specialist, who is leading the British delegation, said that the UK has a rich heritage of life science discovery that has transformed scientific knowledge and continues to unlock clinical and commercial opportunities for many countries, including India. "UK science is world-class, offering industry an opportunity to partner with globally recognised pioneers and innovators. Twenty-five percent of drugs in the UK are made in India and I am looking forward to meeting with Indian experts and discuss how we can Make Tomorrow's Medicine together," he said. Interested parties can also visit and meet UKTI Investment Advisors at Bangalore Bio 2016 who can assist with collaboration opportunities with the UK. ]]> <![CDATA[Need $5 bn more to make biotech a $100 bn sector:Mazumdar-Shaw]]> https://biospectrumindia.com/news/95/7349/need-5-bn-more-to-make-biotech-a-100-bn-sectormazumdar-shaw.html https://biospectrumindia.com/news/95/7349/need-5-bn-more-to-make-biotech-a-100-bn-sectormazumdar-shaw.html Wed, 10 Feb 2016 14:19:51 +0530 The investment in science and technology in India continue to be sub-optimal, said Biocon chairperson Kiran Mazumdar Shaw on Tuesday."Amongst all the countries who invest in science and technology, we are at a sub-optimal level," said Shaw at Bangalore India Bio. Referring to South Korea which is leading investments in science and technology, she said: "I think India needs to basically up its game in science and technology through greater investments." Biocon chairperson was speaking at the inaugural session of the 16th edition of Bangalore India Bio 2016. "India needs to invest $5 billion in biotechnology to achieve the target of growing the sector to $100 billion by 2025", she added. "Today biotechnology is a $11 billion sector, growing at a compounded annual growth rate of 20 percent. We also are aspiring to be a $100 billion sector by 2025," she said. ]]> <![CDATA[Harsha Vardhan inaugurates 16th edition of Bangalore India Bio 2016]]> https://biospectrumindia.com/news/95/7342/harsha-vardhan-inaugurates-16th-edition-of-bangalore-india-bio-2016.html https://biospectrumindia.com/news/95/7342/harsha-vardhan-inaugurates-16th-edition-of-bangalore-india-bio-2016.html Tue, 09 Feb 2016 14:06:00 +0530 Bangalore India Bio 2016 organised by the department of IT, BT and S&T, Government of Karnataka, Vision Group on Biotechnology and event partner MM Activ Sci-Tech Communication was inaugurated by Dr. Harsh Vardhan, Union Minister for Science & Technology and Earth Sciences Government of India. The core theme of the three day event is 'What's trending in BioTech in India' which will be held between Feb 9 2016 to Feb 11 2016. Kiran Mazumdar-Shaw, chairperson Vision Group on Biotechnology in Karnataka and CMD, Biocon, speaking at the event said that the sustained dominance of human capital can share India's science and technology prowess to the world. "India has a rich a human capital and is on a sound platform to take off into the future. There are 7,00,000 post graduates, 15,000 PhDs with 15,000 biotech graduates. We need to convert the rich talent pool. Biotech is a multidisciplinary role with considerable opportunities for science graduates." She also added that Karnataka state would be the first state in India to unveil Orphan drug Policy and release Biotech Policy version III shortly. In his keynote address, Dr. Harsh Vardhan, Union Minister for Science and Technology said that an amount of Rs 10,000 crore has been kept only to support the young people in the country who have bright and brilliant ideas, and I think this is where the country needs to use the young people."I always request the senior and experienced people, those who handle our state-of-the-art laboratories, to please start afresh out-of-the-box process of brainstorming with our younger friends. The 16th edition of Bangalore India Bio 2016 will cover various spectrum of activities including multi-track conferences, international tradeshow, keynote talks, poster sessions, Bio invest, Bio Excellence Awards, Global Biotech Conclave, bioQuiz, Bio Accelerate Programme and other networking events. The conference topics across three days will address over 25 sessions with over 110 speakers and will be attended by 600 delegates. The various conference topics include Making tomorrow's medicine, Oncology and Preceison Medicine, Rare diseases and Orphan Drugs, Agribiotechnology, IoT Healthcare, Proteomics and Bioinformatics, Biotech finishing Schools-HR Workshop, Bio Accelerate & Bio Invest for startups and innovators and many more. The exhibition will have over 80 exhibitors from leading corporate, R&D institites, Start-ups, States of India, Academia as well as Small and Medium companies showcasing their technologies, products and services. Focused pavilions will see participation from consortium of various industry verticals like bio Pharma, Process engineering, Laboratory Technology, Contract Services, IT, Medical Technology, AgriBioTech & BioFuels Business Services and Industrial Biotech and is expected to have 3000 business visitors. International representation this year is from over 10 countries with major delegation from UK, Spain, Korea, and presence from leading countries like USA, Canada, Australia, France, Germany, Poland, Belgium, European Union, taiwan, Malaysia, SAARC and other South Eastrean countries. Global Biotech Conclave is BioTech Leaders conclave discussing on "What's Trending in BioTech India and Will the BioPharma industry Seek an Innovation Path of Growth?. The panel will have leaders from across the globe including representatives from Biocon, Thermo Fisher, Smart Avenue-Korea, Evolva Biotech, Quintiles, UKTI, K&S Partners. This will be an exclusive gathering of the Biotech community. Bio Accelerate Program will be a platform for startups to showcase their ideas and presentations to the industry through bio invest and Bio Accelerate program. The program will have presentations by startups followed by panel discussions. Bio Excellence Awards will recognize the contribution of established and young biotech companies and individuals for their outstanding achievements in the field of Biotechnology. The selection process is conducted by ABLE. ]]> <![CDATA[Novartis' Cosentyx to achieve blockbuster sales following latest FDA approval]]> https://biospectrumindia.com/features/95/8327/novartis-cosentyx-to-achieve-blockbuster-sales-following-latest-fda-approval.html https://biospectrumindia.com/features/95/8327/novartis-cosentyx-to-achieve-blockbuster-sales-following-latest-fda-approval.html Mon, 08 Feb 2016 17:04:55 +0530 The FDA's recent approval of Novartis' Cosentyx for the treatment of adults with active ankylosing spondylitis (AS) and psoriatic arthritis (PsA), will propel the drug to blockbuster status, as it now has three approved indications in the US and Europe, according to an analyst with research and consulting firm GlobalData. Ms Alexandra Annis, GlobalData's Analyst covering Immunology, states that the latest approval will bring exciting new treatment options to US patients dissatisfied with current therapies. Ms Annis explains: "Up to 40% of AS and PsA patients are intolerant of, or are not well-controlled by, anti-tumor necrosis factor therapy (anti-TNF), which was the only biologic for AS before Cosentyx's approval. "Traditionally, swathes of AS and PsA sufferers have been left with unmet needs. Cosentyx marks a substantial turning-point for these disease areas by offering a novel and efficacious alternative to existing therapies." Proof of the drug's effectiveness has been shown by four placebo-controlled Phase III studies. During these trials, the safety and efficacy of Cosentyx was tested in over 1,500 adult patients with active AS or PsA who were intolerant or had an inadequate response to anti-TNFs, or who were naÃ¯ve to biologic therapy. Both AS and PsA patients who took Cosentyx saw statistically significant improvements versus those who took placebos. Ms Annis continues: "Following the European approval of Cosentyx back in November 2015, the drug will be the first-in-class interleukin-17A (IL-17A) inhibitor to enter the AS and PsA treatment paradigm in the US, giving it a major competitive edge in this market. "However, while Cosentyx has the first-to-market advantage within its class, Eli Lilly's ixekizumab, an anti-IL-17 agent, is threatening to compete in the PsA and psoriasis markets, as it is currently under regulatory review for both indications." The analyst adds that Kyowa Hakko Kirin filed an application for marketing approval to the Japanese Ministry of Health, Labour and Welfare for Valeant/AstraZeneca's brodalumab, an IL-17 inhibitor, for the treatment of PsA as well as plaque psoriasis, pustular psoriasis, and psoriatic erythroderma. "With the competition heating up, Cosentyx may not retain its status as the most exciting new treatment in the AS and PsA markets for long," Ms Annis concludes. ]]> <![CDATA[â€œSwagene is the first lab in India that is focused on personalized medicine through molecular diagnostics.â€?]]> https://biospectrumindia.com/interviews/95/8234/swagene-is-the-first-lab-in-india-that-is-focused-on-personalized-medicine-through-molecular-diagnostics-.html https://biospectrumindia.com/interviews/95/8234/swagene-is-the-first-lab-in-india-that-is-focused-on-personalized-medicine-through-molecular-diagnostics-.html Mon, 08 Feb 2016 14:10:02 +0530 Swagene â”€ considered as one of the top 10 startups of 2015, this Chennai-based company is in the business of personalized medicine. Swagene has won both the CII award the DST-Lockheed Martin Award and has also won the Conquest at BITS Pilani, Masterplan at IIM Ahmedabad and Empresario at IIT Kharagpur. In an interaction with Dr Sooraj Ratnakumar, Founder-Scientist of Swagene elaborates on his company's expertise and future plans. To begin with, could you outline what Swagene is all about and how is it different from other diagnostic and medical services company?Dr Vani and I started Swagene to bring advanced molecular diagnostics to Indian shores. Swagene is likely the first lab in India that is focused on personalized medicine through molecular diagnostics. Personalized medicine adds a paradigm shift to medical practice, putting the patient in the centre, rather than the disease. All doctors agree that every patient responds differently to both disease and drugs, and therefore we help tailor therapy to the patient to achieve maximum treatment outcomes. Our mantra is 'excellence in science, excellence in service'. About 50% of our tests are first-in-market to South Asia, borne out of extensive research into modern clinical trials. Only those biomarkers that have clinching evidence of dramatic improvement in treatment come out of our R&D into the market. We're a knowledge sharing lab, and in that effort, our website provides a lot of information on the tests and how they will be useful. Our Infertility and Cardiology tests can be ordered online (www.swagene.com/order/) or over the phone and we'll send a mouthwash collection kit to the patient's home and arrange return courier too! Being the first in developing tests for certain rare cancers such as sarcomas, we've been getting enquiries from several states even in Northern India before launch.Could you describe the people behind the company's inception?I'm a molecular scientist with over 10 years' experience in genetics and molecular biology from top institutions in the world such as the University of Cambridge. I went on to do three postdoctoral fellowships at Cambridge, University of Washington, Seattle, USA and EPFL, Switzerland. With over 10 years' experience in molecular biology and genetics, I've teamed up with Dr Vani, a medical doctor, to offer advanced molecular diagnostics at Swagene. Dr Vani is a Gynaecologist-obstetrician with over 35 years' experience in clinic and surgery in southern India and the Middle-East. Combining medical and scientific expertise, we aim to revolutionize patient-oriented care in South Asia. You are bringing in the concept of personalized medicine? How is this achieved?Would you take a drug if you knew that it's going to be of no use to you, or that it's going to give you severe side-effects? We provide patient-centric care by putting patient at the centre and suggesting individualized therapy that will provide the highest benefit. Personalized medicine aims to bring down healthcare expenses by determining the drugs or procedures that are likely to improve the patient's condition while at the same time preventing severe side effects. In a short time we have developed novel and innovative tests in three medical specialties. We have had to create the market in India. Top specialists in Cardiology, Gynecology and Oncology practicing anywhere from big corporate hospitals to NGOs use our services. This has also resulted in regularly receiving queries and requests from patients and doctors with regard to advanced molecular diagnostics. During this time, we've been recognized as thought leaders in molecular medicine, and have been invited to speak regularly at national and regional conferences, as well as at seminars, CMEs and hospitals. As a result we've reached various specialists in Chennai, Bangalore, Ahmedabad, Kochi and several smaller cities. What are the significant advantages of diagnosis at molecular level and how does it aid prescription? Our infertility tests for women and men are used frequently by gynecologists and andrologists to decide which men will respond to invasive surgeries or hormone therapy to improve their sperm parameters, and how to treat women undergoing IVF for maximum outcome. Our cardiology tests cater to patients with high cholesterol, high blood pressure and those on blood thinners, which is almost everyone who has had a heart attack or stroke. Here we test for the most appropriate medicine and dosage for the individual leading to long-term health benefits and cost savings. Our cancer tests are highly sensitive and benefit oncologists and cancer patients in deciding which therapy to use, as well as monitor treatment response and detect relapse at a very early stage. We've started with certain uncommon cancers such as leukaemias and sarcomas. Going through your education background reveals that your academic journey has been overseas. What made you chose India as a location to set-up Swagene?I did want to stay in Europe for a couple more years, I was done with US life and I didn't want to revisit it despite opportunities there. But India is brimming with hope and potential, and the gap in healthcare is so very wide here that any innovative and meaningful activity will have a substantially bigger impact. Do you have any collaboration with other companies in India as well as abroad? How do these collaborations strengthen your business? We collaborate with labs and hospitals in India and abroad. For instance, we get ethically sourced validated samples for R&D. Our sarcomas panel in development has been specially requested by specialists at some of the top hospitals in India accelerating the arrival of diagnostics for rare cancers to South Asia. Your organization is self-funded. Going down the years do you plan to raise funds through VCs. If yes, how would you deploy the fund?Yes we do plan to raise funds as biotech is a capital-intensive field with above average incubation. The returns will more than compensate for these though. So in order to accelerate our vision of being a leader in molecular diagnostics, we're looking for investment to spur rapid development, marketing, and achieving growth. As a startup there might have been several hiccups since inception. What were those challenges and what kind of success have you seen till date? Setting up an R&D business: The government in India has not awaken to the fact that startups originate with completely novel ideas. For instance, we have to pay high customs duties and other taxes in order to benefit our own population. Even after 'startup India', for DSIR recognition we need to be 'incubated' somewhere to avail benefits. This makes the government loose valuable foreign exchange as the advanced diagnostics are now getting exported to China, Europe and elsewhere.Awareness: We've started with molecular diagnostics in personalized medicine. However, the awareness and importance of personalized medicine is severely lacking in our country. Creating the awareness and thereby creating a market has been a huge challenge. Nevertheless, we've been generating revenues in this difficult niche from the beginning. It has also helped establish ourselves as thought leaders in molecular diagnostics. Are your customers limited to Chennai or is your reach to other cities/countries accomplished?Having spoken at conferences and seminars in Hyderabad, Chennai, Kochi, Trichy etc., we have established trust and reliability among specialists practicing in these areas. While the majority of our patients come from Chennai, we cater to queries and orders from diverse states such as Gujarat, Punjab and Delhi. Our patients have included medical tourists from Sri Lanka, Africa and the Middle-East. Notably though, we also cater to the have-nots by supporting patients from NGOs and government hospitals. We tremendously value our lab, hospital and doctor partners that include corporates, private hospitals, NGOs and public hospitals. How do you perceive Swagene's future? Do you have a road map planned for the next 2 years? Our future plans are two-fold. One is to make molecular diagnostics rapid, easy and affordable. How will this be useful? While advanced countries test for HIV by highly sensitive molecular assays, in India labs still follow serology, which is a much less sensitive and accurate technique. We will make molecular diagnostics available, accessible and affordable. Two is to develop advanced molecular diagnostics in our lab and offer them here. Advanced technologies take several years to reach India, and even then samples are currently being shipped to Europe, USA and even China for these tests adding to both costs as well as turnaround time. We will have completely validated advanced tests in our lab thereby reducing both cost and turnaround time, while contributing to the 'make in India' program. Have you identified any medical technology that has been untapped? Do you believe that the technology can be implemented by Swagene?We're only at the beginning of technological disruption. Do wait and watch. Has Swagene identified a similar company and if acquiring that company is in your mind will it be a prospective buy? For the moment our plans are completely organic growth through partnerships and collaboration. ]]> <![CDATA[Pharma sector sees an increase of 20% hiring as per India Skills Report]]> https://biospectrumindia.com/news/95/8147/pharma-sector-sees-an-increase-of-20-hiring-as-per-india-skills-report.html https://biospectrumindia.com/news/95/8147/pharma-sector-sees-an-increase-of-20-hiring-as-per-india-skills-report.html Mon, 08 Feb 2016 12:17:42 +0530 India Skills Report 2016, a joint initiative of PeopleStrong (India's leading platform based multi-process HR Outsourcing and Recruitment Process Outsourcing and HR Technology Company), Wheebox (Global Talent Assessment Company), in collaboration with Confederation of Indian Industry, LinkedIn (World's largest professional network) and Association of Indian University (AIU) forecasts an overall increase of 14.5 percent in the hiring intent from the current year to the next year. The pharma and healthcare sector has seen maximum hiring with an increase of over 20 percent in the hiring numbers as compared to last year which was 7.2 percent. The sector will create 134000 number of jobs in this year. Thus, hiring in India's pharmaceutical industry is picking up and set to firm up in the next quarter. The industry currently employs about 5.5-5.7 lakh people and has contributed significantly in creating a rich talent pool of researchers, scientists, doctors and project managers. This increase can be attributed to the initiatives by govt of India as well investment in the pharma, life science and healthcare sectors is showing a positive sign. Moreover, Indian pharma industry is likely to be in the top 10 global markets in value terms by 2020. The maximum hiring in Pharma and healthcare will be seen in Karnataka, Kerala and Tamilnadu with employers preferring to hire B.Pharma and M.Pharma respectively. The employers prefer to hire freshers (33.6 percent)and 5 years work experience candidates (32 percent) having skilled domain expertise in the age group of 22-25 years. The need of skilled manpower in the pharmaceutical industry ranges widely from R&D, Quality Assurance (QA), Intellectual Property (IP), manufacturing to even sales and marketing. What the pharma industry needs is to have better policies to retain and nurture the existing talent and equip them with necessary skills. However, this sector is emerging as a popular choice amongst Gen Y, since the nature of work, primarily treating patients and research for new drug discoveries plays an integral role in meeting their key career aspirations. The sector still prefer to look for candidates through job portals (25 percent) and HR Consultants (18.75 percent). In comparison to last year sourcing of candidates has slightly decreased through Job portals 22 percent and Consultants 15 percent. ]]> <![CDATA[Another FDA approval in Dr Reddy's kitty]]> https://biospectrumindia.com/news/95/8111/another-fda-approval-in-dr-reddys-kitty.html https://biospectrumindia.com/news/95/8111/another-fda-approval-in-dr-reddys-kitty.html Mon, 08 Feb 2016 12:16:20 +0530 Dr Reddy's has announced that its US subsidiary, Promius Pharma has received approval for Sernivo (betamethasone dipropionate) Spray, 0.05 percent from the US Food and Drug Administration (US FDA). Sernivo Spray, a prescription topical steroid, is indicated for the treatment of mild to moderate plaque psoriasis in patients 18 years of age or older. The commercial launch of the product is planned for the coming quarter. Commenting on the approval, Mr G V Prasad, co-chairman and CEO, Dr Reddy's Laboratories said, "The FDA approval of Sernivo Spray is a significant milestone for Promius, as it validates our committed efforts and resources to developing differentiated dermatology products from concept to commercial launch. We are delighted to receive a first round FDA approval of Sernivo Spray as we look to expand our portfolio of medical dermatology products available in the US market." Promius has conducted two successful multi-center, randomized, double-blind, vehicle-controlled clinical trials in subjects aged 18 years and older with moderate plaque psoriasis to evaluate the safety and efficacy of Sernivo Spray. In both trials, randomized subjects applied Sernivo Spray or vehicle spray to the affected areas twice daily for 28 days. Enrolled subjects had body surface area of involvement between 10 to 20 percent, and an Investigator Global Assessment (IGA) score of 3 (moderate). Efficacy was assessed as the proportion of subjects who were considered a treatment success (defined as having an IGA score of 0 or 1 [clear or almost clear] and at least a 2-scale reduction from baseline). Treatment success was achieved in significantly more subjects using Sernivo than Vehicle at both Day 15 and Day 29 across both studies. At Day 29 in Studies 1 and 2, Sernivo achieved treatment success of 42.7 percent and 34.5 percent compared to vehicle success rates of 11.7 percent and 13.6 percent, respectively (p < 0.001). Mr Raghav Chari, executive vice-president of Proprietary Products at Dr Reddy's and president of Promius Pharma said, "As an emerging leader in the dermatology space, we are committed to developing innovative treatment options and support services for clinicians and patients. The approval of Sernivo emphasizes our ongoing efforts and we look forward to a successful launch of Sernivo Spray in the coming quarter." ]]> <![CDATA[Head & neck cancer market to quadruple to $1.53 bn by 2024]]> https://biospectrumindia.com/features/95/8008/head-neck-cancer-market-to-quadruple-to-1-53-bn-by-2024.html https://biospectrumindia.com/features/95/8008/head-neck-cancer-market-to-quadruple-to-1-53-bn-by-2024.html Fri, 05 Feb 2016 13:47:37 +0530 The treatment market for head and neck squamous cell carcinoma (head and neck cancer) will expand almost four-fold from $386 million in 2014 to $1.53 billion by 2024, representing a strong Compound Annual Growth Rate (CAGR) of 14.8%, according to research and consulting firm GlobalData. The company's latest report states that the major drivers of this impressive growth, which will occur across the seven major markets (7MM) of the US, France, Germany, Italy, Spain, the UK and Japan, include an increase in disease prevalence, and the launch of multiple premium-priced therapies for recurrent and metastatic disease. These will be led by immuno-oncology products including Bristol-Myers Squibb's Opdivo and Merck's Keytruda, which are anticipated to enter the head and neck cancer market in late 2016 and 2017 respectively. Dr Amy Yip, GlobalData's Analyst covering Oncology, states that the release of new immuno-oncology agents, particularly immune checkpoint inhibitors, has created much interest of late. Dr Yip explains: "Monoclonal antibodies targeting programmed cell death 1 (PD-1) receptor or programmed death-ligand 1 (PD-L1), including Opdivo, Keytruda, and durvalumab, have generated much excitement in the medical community, with their promising early data and good patient responses. "GlobalData expects a high patient uptake for these drugs when they are approved, with Keytruda appearing as the market leader in the head and neck cancer space. This is due to its early launch in first-line therapy for recurrent or metastatic head and neck squamous cell carcinoma, allowing it to garner a larger target patient pool compared with Opdivo, which is anticipated to launch only in the second-line setting." As a result, GlobalData forecasts that Keytruda will achieve peak sales in head and neck cancer treatment of almost $500 million by 2024 in the 7MM. Despite the enthusiasm surrounding upcoming immuno-therapies, which could command an annual cost of therapy in the US of $150,000 in other cancer indications such as melanoma, there are no biomarkers available able to identify how well a given patient will respond to these treatments. Dr Yip concludes: "With such a high price tag, a reliable predictive biomarker to aid patient selection and to avoid giving therapeutics to those who are unlikely to respond is highly desirable. Indeed, it would encourage greater uptake in biomarker-positive patients and avoid unnecessary financial burdens for biomarker-negative patients." ]]> <![CDATA[There's still time to stop TPP from cutting off critical affordable generic medicines: MSF]]> https://biospectrumindia.com/news/95/8154/theres-still-time-to-stop-tpp-from-cutting-off-critical-affordable-generic-medicines-msf.html https://biospectrumindia.com/news/95/8154/theres-still-time-to-stop-tpp-from-cutting-off-critical-affordable-generic-medicines-msf.html Fri, 05 Feb 2016 12:48:17 +0530 As representatives from the United States and 11 other Pacific-Rim countries gather in New Zealand to sign the Trans-Pacific Partnership (TPP) trade agreement today, the fight to protect access to medicines in TPP countries is intensifying at the national level, with legislative processes starting that will determine if the deal is finally ratified and implemented. The international medical humanitarian organization Doctors Without Borders/MÃ©decins Sans FrontiÃ¨res (MSF) is calling on the more than 800 million people living in TPP countries to urge their governments to reject the deal unless harmful provisions that lock in high drug prices are removed. "The fight to stop this irresponsible trade deal from going into effect is far from over," said Ms Judit Rius Sanjuan, MSF's US Access Campaign manager and legal policy advisor. "The TPP deal being signed today is the worst trade deal ever for access to medicines and will make life-saving treatments unaffordable for those who need them most. That's why it's critical that people demand their governments uphold their obligations to protect public health and fight back against unjust profiteering that would be enabled by the TPP." The current TPP countries are United States, Australia, Brunei Darussalam, Canada, Chile, Japan, Malaysia, Mexico, New Zealand, Peru, Singapore and Vietnam, but more countries could sign on, and the agreement is being billed as a blueprint for future trade deals. The TPP deal was agreed in October after more than five years of negotiations that were conducted in secret, without the opportunity for public review. The agreement is now public and people affected by the TPP can finally have their say and tell their legislators and governments not to ratify the deal unless damaging provisions that will harm access to medicines are removed. If implemented, the TPP will extend pharmaceutical company monopolies and prevent people from accessing life-saving medicines by blocking or delaying the availability of price-lowering generic drugs. Additionally, the TPP would dismantle public health safeguards and force developing countries to change their laws to incorporate abusive intellectual property protections for pharmaceutical companies, making it harder for people - and organizations like MSF that serve them - to buy the affordable medicines they need. The high price of medicines is a global problem affecting countries at every income level, but people in developing countries where MSF has operations are particularly hard hit by high prices, as most people pay for medicines out of pocket. High prices and strict intellectual property rules will also do nothing to solve the global crisis of biomedical innovation, including a lack of new medicines to address antibiotic resistance. High drug prices divert government resources away from financing needs-driven research and development in favor of padding the bottom line and the pockets of multinational drug companies. In the US, Congressional approval is still needed for the TPP to become law. The TPP deal is being considered under the "fast-track" authority, which allows Congress to ratify or reject the deal as a whole. MSF urges Congress to ensure that the US doesn't sign a deal that damages access to affordable medicines or reneges on previous commitments to public health, including the bipartisan 2007 May 10 Deal. "The TPP is designed to extend beyond the current 12 countries and to negatively impact patients in Indian and the whole ASEAN region. That is why today we are releasing letters asking the government of India and the ASEAN Member States to reject the TPP." Said Ms Leena Menghaney, Head of South Asia, MSF Access Campaign. "The TPP signing today is one step in the process, but efforts to stop the TPP from blocking people's access to affordable medicines is far from over." ]]> <![CDATA[Aurobindo Pharma receives FDA approval for Isosulfan blue injection]]> https://biospectrumindia.com/news/95/8187/aurobindo-pharma-receives-fda-approval-for-isosulfan-blue-injection.html https://biospectrumindia.com/news/95/8187/aurobindo-pharma-receives-fda-approval-for-isosulfan-blue-injection.html Fri, 05 Feb 2016 12:46:13 +0530 Aurobindo Pharma has received final approval from the US Food and Drug Administration (USFDA) to manufacture and market Isosulfan Blue Injection, 1 percent (50 mg/5 mL) single-dose vials. The product is expected to be launched in Q4 FY15-16. The approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) LymphazurinTM Injection, 1 percent, of Covidien. Isosulfan Blue Injection under Cardio Vascular therapeutic group, is used in a lymphography procedure. Isosulfan Blue Injection upon subcutaneous administration, delineates the lymphatic vessels draining the region of injection. The approved product has an estimated market size of $57 million for the twelve months ending December 2015 according to IMS. ]]> <![CDATA[Bharat Biotech announces breakthrough for Zika vaccine ]]> https://biospectrumindia.com/news/95/6904/bharat-biotech-announces-breakthrough-for-zika-vaccine-.html https://biospectrumindia.com/news/95/6904/bharat-biotech-announces-breakthrough-for-zika-vaccine-.html Fri, 05 Feb 2016 12:45:57 +0530 Vaccines and Bio-Therapeutic manufacturer, Bharat Biotech, announced breakthrough in developing world's first, 2 promising candidates ZIKAVAC vaccines for Zika infection. "We have two ZikaVac vaccine candidates in development; one is a recombinant vaccine and another an inactivated vaccine that has reached the stage of pre-clinical testing in animals," Dr Krishna Ella, CMD, Bharat Biotech announced. Bharat Biotech began work on the Zika Virus a year ago. WHO just announced a disease linked to the Zika virus in Latin America poses a global public health emergency requiring a united response. Zika is now present in 23 countries. Brazil, the hardest-hit country, has reported around 3,530 cases of the devastating birth defect called microcephaly in 2015 that are strongly suspected to be related to Zika. The Zika virus is spread by mosquitoes of the Aedes genus, which can breed in a pool of water as small as a bottle cap and usually bite during the day. The mosquito-transmitted infection is related to Dengue, Yellow Fever and West Nile virus. "We believe we have an early mover advantage in developing the ZIKAVAC and we are probably the first in the world to file for global patent for Zika Vaccine candidates. We have two candidate vaccines in development. One of them is an inactivated vaccine that has reached the stage of pre-clinical testing in animals Currently our efforts are towards scale up and characterization of the vaccine product. Our interest in Zika virus, an obscure virus when we started the project a year ago was that the clinical features at an early stage of infection are indistinguishable from that of Dengue and Chikungunya. Right now consistency in process development has been achieved at 40 L pilot scale. Furthermore, a recombinant vaccine using the surface antigens of the virus is being concurrently developed," said the firm in a statement. "Considering that women of childbearing age and pregnant women are the prime target group for Zika virus vaccine, we consider safety as the overriding factor in development of a new vaccine for this virus. The vaccine methods developed early on, before the devastating consequences of the epidemics in Brazil came to light provided us a push to accelerate vaccine development," said Dr Sumathy, director, R&D Bharat Biotech. In the absence of knowledge on viral pathogenesis and immune correlates required for protection, an early start in vaccine development has nevertheless provided a fair advantage to face the eventuality of an epidemic outbreak in the region," Dr Sumathy added. "The first thing is to be prepared for the worst," says Dr Ella said who along with Dr Sumathy and the R&D team at Bharat Biotech is working in the Zika vaccine program said. We hope to announce its arrival of ZIKAVAC to the world as early as possible. ]]> <![CDATA[Eppendorf launches new Benchtop Centrifuge ]]> https://biospectrumindia.com/news/95/8170/eppendorf-launches-new-benchtop-centrifuge-.html https://biospectrumindia.com/news/95/8170/eppendorf-launches-new-benchtop-centrifuge-.html Fri, 05 Feb 2016 12:45:40 +0530 Eppendorf launches a new 4-liter benchtop, Centrifuge 5920 R that delivers extraordinary high capacity in a very compact and ergonomic product design. It has similar dimensions as competing refrigerated 3 Litre models and yet features a superior capacity of up to 4 x 1,000 mL; thus making it the ideal instrument for high-throughput applications. It features a powerful state-of-the-art refrigeration system with advanced temperature management to keep your samples safe. Eppendorf is a leading life science company that develops and sells instruments, consumables, and services for liquid handling, sample handling, and cell handling in laboratories worldwide. ]]> <![CDATA[New Drugs from Abbvie, Gilead, Intercept and Merck forecast to achieve blockbuster status by 2020 ]]> https://biospectrumindia.com/news/95/6894/new-drugs-from-abbvie-gilead-intercept-and-merck-forecast-to-achieve-blockbuster-status-by-2020-.html https://biospectrumindia.com/news/95/6894/new-drugs-from-abbvie-gilead-intercept-and-merck-forecast-to-achieve-blockbuster-status-by-2020-.html Thu, 04 Feb 2016 11:28:13 +0530 According to a new report from the Intellectual Property and Science business of Thomson Reuters, there are a total of seven new therapeutics currently in the new drug development pipeline that should enter the market this year and surpass $1 billion in annual sales by 2020. Two of these are projected to top $2 billion in annual sales. These projections are detailed in the annual Drugs to Watch 2016 report, which mines pharmaceutical industry data to forecast the new therapeutics with the largest marketplace potential. The two new drugs projected to exceed $2 billion in annual sales are: a chronic liver disease treatment from Intercept Pharmaceuticals and Sumitomo Dainippon Pharma with the chemical name obeticholic acid; and an anti-HIV-1 infection treatment from Gilead Sciences and Japan Tobacco which combines the chemicals emtricitabine and tenofovir alafenamide. A key trend in 2016 is the continued development of more convenient fixed-dose, all-oral regimens for HIV and HCV (Hepatitis C). The analysis spotlights the following seven potential blockbusters, ranked by highest sales forecasts: Ranking (By highest sales forecast for 2020) Drug Disease Pharmaceutical company 2020 forecast sales ($ billions) 1 obeticholic acid chronic liver diseases Intercept Pharmaceuticals and Summitomo Dainippon Pharma 2.621 2 Emtricitabine+tenofir alafenamide(F/TAF) HIV-1 infection Gilead sciences and Japan Tobacco 2.006 3 tenofir alafenamide+emtricitabine+ rilpivirine(R/F/TAF) HIV-1 infection Gilead sciences and Janseen R&D 1.572 4 MK-5172A HCV infectiom Merck and co 1.537 5 venetoclax chronic lymphocitic leukemia Abbvie 1.477 6 Nuplazid Parkinson's disease psychosis ACADIA Pharmaceuticals 1.409 7uptravipulmonary arterial hypertensionNippon Shinyaku and Actellion1.268 The relationship between drug prices and the costs of development is expected to be a major focal point for drug companies, investors, regulators and politicians this year," said Mr hard Harrison, chief scientific officer, Intellectual Property & Science, Thomson Reuters. "With the rise of global healthcare costs, the need to demonstrate meaningful impact will be greater than ever for pharmaceutical companies. These seven drugs are likely to figure prominently in those discussions." Having accurately anticipated that 11 new potential blockbuster drugs would enter the market in 2015 - all of which are still forecast to reach blockbuster status by 2019 (with the exception of Gardasil 9, for which forecasts were not available as of January 2016) - the Drugs to Watch report addresses a new line-up of significant therapeutics for the year ahead. Thomson Reuters analysts utilized Cortellis Competitive Intelligence, the pharmaceutical industry's leading source for drug pipeline, deals, patents, and company content to forecast the new-to-market drugs expected to lead the pack in sales and potentially emerge as blockbusters (earning $ 1 billion+) by 2020. ]]> <![CDATA[Leading Allergists discuss solutions to alleviate the Allergy burden in India]]> https://biospectrumindia.com/news/95/8261/leading-allergists-discuss-solutions-to-alleviate-the-allergy-burden-in-india.html https://biospectrumindia.com/news/95/8261/leading-allergists-discuss-solutions-to-alleviate-the-allergy-burden-in-india.html Thu, 04 Feb 2016 11:27:53 +0530 Indian College of Allergy ,Asthma, and Applied Immunology organizes the 4-day (January 28 - 31, 2016) 49th National Conference of Indian College of Allergy, Asthma & Applied Immunology 'ICAAICON-2015' at Saveetha Medical College and Hospital to bring together 300 national and international allergy experts under one roof for discussion on prevalence, trends and latest advances in Allergy, Asthma and Immunology. World Allergy Organisation (WAO) states that an estimated 25 percent of the global population suffers from allergic and immunologic diseases such as bronchial asthma, allergic rhinitis, atopic dermatitis and eczema etc. It is estimated that every fourth Indian suffers from some kind of allergy once in their lifetime. Commenting on the allergy trend in India, Dr A B Singh, Emeritus Scientist(Ex ) , Institute of Genomics and Integrative Biology, Delhi, and Secretary of Indian College of Allergy ,Asthma and Applied Immunology said, "Top allergies observed in India are that of respiratory, skin, food and dust mites. About 20-30 percent of India's population suffers from at least one of the allergic diseases. 80 percent of allergy cases in India are hereditary. Dr A B Singh also spoke of his observation on pollen allergy trend - "Pollen allergens from trees, grasses, flowers and weeds cause respiratory allergies in 20 percent of the India's allergic population. The trend increases at the onset of spring and autumn." Dr Singh has identified important pollen allergens of the country as a result of more than 30years of experience in research. Allergies are an over-reaction of the immune system in the form of antibodies to exposed proteins which are not necessarily harmful. These antibodies cause an allergic reaction which cause symptoms in the nose, lungs, throat, sinuses, ears, lining of the stomach or on the skin. Some symptoms include incessant sneezing, runny nose (rhinitis), difficulty breathing, hives and dermatitis. Allergies if undiagnosed or ill-managed may culminate to persistent allergic rhinitis and severe asthma. Stating the increase of Allergies in Chennai, Dr K Nagaraju, Organising Secretary and Allergist at Apollo Children's Hospital, Chennai said, "In the past years, there has been an ~15-20 percent increase of allergy incidence in Chennai. House dust mites (~50 percent) is the leading allergen in Chennai followed by pollen (23 percent), insect (16 percent) and food (1-5 percent) allergens. Allergic rhinitis is prevalent in about 42 percent of people between 20 -40 years. Prevalence of coexisting allergic rhinitis and asthma is highest amongst children & young adults (5- 20 years) at 45 percent prevalence." Highlighting the need for allergy management through accurate diagnosis and treatment, Dr S N Gaur, Head of Pulmonary Medicine, Vallabhbhai Patel Chest Institute (VPCI), Delhi said, "In India, allergies are not considered to be a serious health concern due to low awareness of the causes and the impact. About 40 percent of people with allergic rhinitis develop asthma at some stage in life and about 80% asthmatics suffer from allergic rhinitis.[2] Timely, accurate diagnose allergies is important for appropriate allergy management to prevent future complications. Skin prick test is the global, gold standard method of allergy diagnosis as it is quick, convenient, cost-effective and can be used from infancy to old age.[1] Anti-allergic drugs provide temporary relief without treating the root cause and its prolonged use causes side-effects such as sleep disturbances and obesity. Allergen Immunotherapy is the recommended treatment for allergies since it is the closest attempt towards allergy cure." ]]> <![CDATA[India is the Silicon Valley of the East: Dr Kiran Mazumdar]]> https://biospectrumindia.com/news/95/4129/india-is-the-silicon-valley-of-the-east-dr-kiran-mazumdar.html https://biospectrumindia.com/news/95/4129/india-is-the-silicon-valley-of-the-east-dr-kiran-mazumdar.html Wed, 03 Feb 2016 19:06:01 +0530 Bangalore hosted its first-day of the most anticipated three-day investors' event, Invest Karnataka 2016, a global meeting platform aimed at bringing biggest business minds and investors together to accelerate development through technology, innovation, inclusivity and sustainability. In one of the parallel sessions on Biotechnology sector, Dr Kiran Mazumdar, CMD, Biocon, delivered a presentation talking about India as a global innovation hub for the Biotech industry. She spoke about the exclusivity of Karnataka in the Biotech sector. "When I started Biocon, there were very few people who backed it up. It is not only Karnataka's rich human capital, but it has also created a very unique model - for every other State and other parts of the world - a close partnership between the industry, academia and the Government." She pointed that Biotech is an innovative sector which needs risk-takers. "Bangalore can boast itself as the Science and start-up capital because the city is full of first-generation entrepreneurs, which means you have plenty of risk-takers and this is enabling Bangalore to be the start-up capital of the country, not just in the IT sector, but also in Biotech. Innovation in Biotech starts with risk-taking. We need to ensure that innovation is unique, differentiating and path-breaking. This is what we expect start-ups to do, and we have large number of start-ups licensing their proprietary technologies to MNCs at premium values," she said. In India, 50% of all the Biotech companies are located in Karnataka, which has 19,000+ highly-qualified professionals, with 1000-plus R&D centers, and the State's Biotech sector contributing 30% of the national revenues. She took the audience through various eras of Indian Biotech in the last 4 decades. "The 80's was an era of enzymes followed by the vintage era of vaccines in the 90's. We produce largest number of vaccines in the world making India the 'Vaccine Capital' of the world. The year 2000 was the age of Internet belonging to genomics. The 2010's was the birth of biologics and biotech drugs, transforming the way diseases are treated. Low-cost and rich talent pool enabled India to develop world-class biologics addressing affordability and accessibility," she noted. Dr Kiran also laid emphasis on skill development, expertise and excellence. "When it comes to leadership, it's about building skills, expertise and excellence. You have to invest in building skills and scale. Companies started investing very heavily in building expertise. Many companies are setting up or outsourcing research services. This is a bigger investment opportunity," she stated. She voiced that Biotech is the new growth engine for the Indian economy. "Indian Biotech has recorded 20% CAGR in the last 10 years. The country has an ambition to realize Biotech revenues of $100 billion by 2025, which I think is achievable by enabling policies and regulations which will help build skills whether it is Biopharma, BioIT or enzymes," she commented. India is ranked 12th in the Biotech sector globally, and 3rd in APAC after China and Korea. She justified what makes India an innovation hub. "Low-cost of development, large network of academic institutions, availability of scientific and engineering talent, large pool of drug-naÃ¯ve patients, genetic diversity of patient population enable different opportunities and have different strategies around clinical development," she said. She also said that India can serve as an attractive manufacturing destination. The Indian Government aims to spend $3.7 billion on Biotech between 2012-17, and the country has the 4th largest area under GM crops. India is also credited with having the 2nd highest number of USFDA-approved plants after the US, with manpower costs and the cost of manufacturing less than half compared to the West. Dr Kiran added that India's start-up ecosystem will depend on innovations coming out academic labs. "Institutions will rely on licensing incomes and royalties. Entrepreneurs should do their proof-of-concept and pre-clinical commercialization phase and add value to the innovation. The industry later should come up and commercialize products, enabling funding of the academic institutes and entrepreneurs by paying royalties," she observed. Karnataka was the first State in the country to introduce the Biotech Policy in 2001. "We have sound infrastructure and largest Biotech clusters in India, and sector-specific SEZs focusing on Biotech. We also have a comprehensive Biotech Policy and the Biotech Vision Group, with representations from the Government, industry and the academia," she remarked. She said that Bangalore is the Silicon Valley of the East. "In Biopharma there are huge opportunities for India, investors and organizations. We believe biosimilars market will touch $10 billion by 2020. Developing new drugs in India in Biotech is a $50 billion market, and the CRAMS a $40 billion market in the next four years. India has the potential to be the innovation hub for biosimilars and biologics. Global life sciences companies are looking at India as a CMO destination for many biologics, since India is a large and growing market for biologics," she concluded, quoting a Nobel Prize winner. 'Innovation consists of seeing what everybody has seen and thinking what nobody has thought.' - Dr Albert Szent-Gyorgyi ]]> <![CDATA[Pharma cos must assess real-world evidence to keep up with global market access landscape shifts]]> https://biospectrumindia.com/features/95/5945/pharma-cos-must-assess-real-world-evidence-to-keep-up-with-global-market-access-landscape-shifts.html https://biospectrumindia.com/features/95/5945/pharma-cos-must-assess-real-world-evidence-to-keep-up-with-global-market-access-landscape-shifts.html Tue, 02 Feb 2016 12:07:53 +0530 As the overall costs of drugs continue to increase and pricing pressures shift the dynamics of the healthcare market, pharmaceutical companies must analyze real-world trends in different treatment spaces, and assess existing and expected levels of competition, in order to gain optimal market access, says business intelligence provider GBI Research. According to the company's latest CBR Pharma report, this kind of analysis, known as Health Economics and Outcome Research (HEOR) is an important element of market access which encompasses aspects such as real-world data, quality of life, budget impact, and cost-effectiveness, along with clinical efficiency. Mr Rodrigo Gutierrez Gamboa, Managing Analyst for GBI Research, states that: "Traditionally, once a drug was registered in a country, it was automatically reimbursed and available for an eligible population of patients. Today, however, regulatory approval does not guarantee market access, as the cost-effectiveness of any given drug must be thoroughly demonstrated before it receives coverage in a health system. "HEOR offers some solutions to this aspect of drug development and marketing, as it helps to collect the evidence that demonstrates the impact of new therapies on healthcare budgets, which in turn will help to price products optimally. "Cost-effectiveness takes into consideration the concerns of regulators and payers, which helps speed up a product's entry into the market. Hence, such studies should be carried out alongside clinical trials by including end points of interest in the design." Currently, a significant number of European payers, continuing to play a key role in pricing decisions, expect companies to conduct comparator trials for easy evaluation of drug effectiveness in order to list the drugs on formularies. Mr Gutierrez Gamboa notes: "Ultimately, this might change the information basis for investment decision and commercial expectations. Therefore, it is important not only to gather the relevant information from the market, but to ensure that this information has the right weight and presence." ]]> <![CDATA[COPD treatment pipeline lacks robust innovation?]]> https://biospectrumindia.com/features/95/8227/copd-treatment-pipeline-lacks-robust-innovation.html https://biospectrumindia.com/features/95/8227/copd-treatment-pipeline-lacks-robust-innovation.html Tue, 02 Feb 2016 12:06:48 +0530 Despite an influx of new therapies over recent years, the Chronic Obstructive Pulmonary Disease (COPD) treatment market has a number of unmet needs, and the innovation in its product development pipeline is lagging in comparison to other indications, says business intelligence provider GBI Research. According to the company's latest report, while currently-available drugs aim to manage the symptoms associated with COPD by reducing the frequency and severity of exacerbations and improving lung function, none have been shown to modify long-term disease progression. Mr Yasser Mushtaq, Senior Analyst for GBI Research, states that in addition to the need for disease-modifying drugs, much of the unmet need associated with COPD has been linked to poor adherence to medication. Mr Mushtaq says: "Tedious drug delivery processes and the need for frequent daily doses ultimately lead to poor compliance and management of COPD symptoms. As a consequence, drug development programs are focusing on long-acting medication. "There is also a need for alternative anti-inflammatory agents. Traditionally reliant on Inhaled Corticosteroids (ICS), analysis of the COPD product development pipeline has confirmed greater interest into novel anti-inflammatory agents." The analyst adds that beyond ICS therapy, the current market offers very limited anti-inflammatory treatment, which is a notable unmet need in COPD. GBI Research's report also states that first-in-class product development in COPD treatment constitutes only 16.5% of the pipeline, which is relatively small compared to other respiratory indications. For example, asthma therapeutics exhibit greater innovation, with first-in-class products making up 23% of the pipeline. Mr Mushtaq continues: "There are suggestions that such innovation is filtering through into the COPD therapeutics pipeline, as asthma and COPD share mechanisms of pathophysiology, making it likely that products will be applicable to both diseases. "In this way, innovations in the asthma treatment pipeline will significantly aid that of COPD. However, there is no clear indication that disease-modifying drugs will be released onto the COPD market any time soon, making it an attractive proposition for major pharma players." ]]> <![CDATA[Dr Reddy's receives tentative FDA approval for Zenavod ]]> https://biospectrumindia.com/news/95/4042/dr-reddys-receives-tentative-fda-approval-for-zenavod-.html https://biospectrumindia.com/news/95/4042/dr-reddys-receives-tentative-fda-approval-for-zenavod-.html Tue, 02 Feb 2016 11:10:10 +0530 Dr Reddy's Laboratories has announced that the US Food and Drug Administration (US FDA) tentative approval for Zenavod (doxycycline) capsules, 40 mg. Zenavod is a tetracycline-class drug indicated for the treatment of only inflammatory lesions (papules and pustules) of rosacea in adult patients. Promius Pharma, the US subsidiary of Dr Reddy's will be responsible for commercializing Zenavod in the US market. "This development confirms our ability and commitment to develop differentiated dermatology products leveraging the in-house capabilities of Promius Pharma and Dr Reddy's," stated Mr G V Prasad, CEO and co-chairman, Dr Reddy's. He continued, "We are pleased to receive a tentative FDA approval of Zenavod and will be working with external parties and the FDA to gain a full approval." The approval of the New Drug Application (NDA) is tentative because the FDA has determined that the drug meets all of the required quality, safety, and efficacy standards for approval, but it is subject to an automatic stay of final approval for up to 30 months pending a patent infringement process under the Drug Price Competition and Patent Term Restoration Act ("Hatch Waxman"). "The tentative approval for Zenavod is another step toward providing an additional option for people with rosacea in the US, who need oral treatment," said Dr Raghav Chari, executive vice president of proprietary products at Dr Reddy's and president of Promius Pharma, "We are looking forward to the commercial launch and continuing to enhance our support of medical dermatologists and their patients." ]]> <![CDATA[B-Cell Non-Hodgkin's Lymphoma treatment market to stutter to $5.45 bn by 2024]]> https://biospectrumindia.com/features/95/5499/b-cell-non-hodgkins-lymphoma-treatment-market-to-stutter-to-5-45-bn-by-2024.html https://biospectrumindia.com/features/95/5499/b-cell-non-hodgkins-lymphoma-treatment-market-to-stutter-to-5-45-bn-by-2024.html Mon, 01 Feb 2016 17:16:23 +0530 The B-cell Non-Hodgkin's Lymphoma (NHL) treatment market is set to rise slowly in value from $4.38 billion in 2014 to reach $5.45 billion by 2024, representing a very modest Compound Annual Growth Rate (CAGR) of 1%, according to research and consulting firm GlobalData. The company's latest report states that such limited growth, which will occur across the seven major markets (7MM) of the US, France, Germany, Italy, Spain, the UK, and Japan, will be hindered by the entry of biosimilars and generics during the forecast period, combined with a weak pipeline. Dr Cai Xuan, GlobalData's Analyst covering Oncology, says: "The launch of biosimilar rituximab across the 7MM in 2018 will have a significant negative impact on branded drug growth. Also significant will be the impact that generic bendamustine and lenalidomide will have on the treatment space as they are released at various intervals in each region during the forecast period. "Furthermore, no late-stage drugs in the NHL pipeline are expected to achieve blockbuster status, as rituximab-based chemotherapy regimens are gold-standard therapies that dominate the NHL treatment algorithms across both indolent and aggressive forms of the disease." The analyst adds that the high clinical efficacy and established reputation of these immunochemotherapies makes developing a replacement therapy in the first-line setting exceedingly difficult. Dr Xuan continues: "Despite this, there is potential for some of the current pipeline agents to be incorporated into the NHL treatment algorithms across indolent and aggressive lymphomas and in various lines of therapy. "For example, Roche's Gazyva is being evaluated across the follicular lymphoma and diffuse large B-cell lymphoma settings, while the developers of Arzerra, copanlisib, and duvelisib are focusing on indolent NHL." GlobalData believes that while new players entering the NHL treatment market must overcome various obstacles, opportunities remain within this segment. Dr Xuan concludes: "The NHL market is in need of more cost-effective therapeutics, improved consolidation/maintenance therapies for follicular NHL patients, and the development of novel drugs for NHL patients, all of which present significant opportunities for development within this treatment space." ]]> <![CDATA[India's pharma market to skyrocket from $20 bn in 2015 to $55 bn by 2020]]> https://biospectrumindia.com/features/95/7396/indias-pharma-market-to-skyrocket-from-20-bn-in-2015-to-55-bn-by-2020.html https://biospectrumindia.com/features/95/7396/indias-pharma-market-to-skyrocket-from-20-bn-in-2015-to-55-bn-by-2020.html Mon, 01 Feb 2016 17:15:24 +0530 The pharmaceuticals market in India, valued at $20 billion in 2015, is set to soar to $55 billion by 2020, representing an impressive Compound Annual Growth Rate (CAGR) of 22.4%, says research and consulting firm GlobalData. According to the company's latest report, India's rapidly growing generics market is the primary driver of the nation's pharmaceutical sector, with sales expected to soar by nearly 84% to $26.1 billion in 2016. Generic drugs, with their low costs and easy accessibility, now dominate India's pharmaceutical space, accounting for around 70% of the market. Mr Adam Dion, GlobalData's Senior Industry Analyst, states that: "India supplies 20% of global generic medicines in terms of export volume, making the country the largest provider of generic medicines globally. "Indeed, Indian pharmaceutical companies are now exporting to countries like Brazil, Mexico, South Africa, Russia and Japan, and, according to India's Ministry of Commerce and Industry, the nation's pharmaceutical export segment has more than doubled from $7.8 billion in 2008 to $16.5 billion in 2014." Another driver of India's pharmaceutical sector is the potentially lucrative biosimilars market, which is expected to increase to $40 billion globally by 2020, as biologic treatments are introduced for diseases such as diabetes, cancer, multiple sclerosis, and rheumatoid arthritis. Mr Dion explains: "One company benefiting from its leading position in the biosimilars market is Dr. Reddy's. In 2007, Dr. Reddy's was the first to launch a biosimilar version to Roche's cancer drug rituximab (Rituxan), and has four other biosimilars on the market. "The company's drug characterization strategy and quality measures give Dr. Reddy's a significant competitive advantage that reduces the uncertainty of potential outcome differences when used in patients." ]]> <![CDATA[Merck gets FDA nod for Hep C drug]]> https://biospectrumindia.com/news/95/5633/merck-gets-fda-nod-for-hep-c-drug.html https://biospectrumindia.com/news/95/5633/merck-gets-fda-nod-for-hep-c-drug.html Mon, 01 Feb 2016 11:07:57 +0530 Merck, known as MSD outside the United States and Canada, has announced that the US Food and Drug Administration (US FDA) has approved ZEPATIER(elbasvir and grazoprevir) for the treatment of adult patients with chronic hepatitis C virus (HCV) genotype (GT) 1 or GT4 infection, with or without ribavirin (RBV), following priority review by the FDA. ZEPATIER is a once-daily, fixed-dose combination tablet containing the NS5A inhibitor elbasvir (50 mg) and the NS3/4A protease inhibitor grazoprevir (100 mg). The FDA previously granted two Breakthrough Therapy designations to ZEPATIER, for the treatment of chronic HCV GT1 infection in patients with end stage renal disease on hemodialysis, and for the treatment of patients with chronic HCV GT4 infection. Across multiple clinical studies, ZEPATIER achieved high rates of sustained virologic response ranging from 94 to 97 percent in GT1-infected patients, and 97 to 100 percent in GT4-infected patients. Sustained virologic response is defined as HCV RNA levels measuring less than the lower limit of quantification at 12 weeks after the cessation of treatment (SVR12), indicating that a patient's HCV infection has been cured. ZEPATIER is not for use in patients with moderate or severe hepatic impairment (Child-Pugh B or C). ZEPATIER also is not for use with organic anion transporting polypeptides 1B1/3 (OATP1B1/3) inhibitors (e.g., atazanavir, darunavir, lopinavir, saquinavir, tipranavir, cyclosporine), strong cytochrome P450 3A (CYP3A) inducers (e.g., carbamazepine, phenytoin, rifampin, St. John's Wort), and efavirenz. If ZEPATIER is administered with RBV, healthcare professionals should refer to the prescribing information for RBV as the contraindications, warnings and precautions, adverse reactions and dosing for RBV also apply to this combination regimen. "Continued innovation is needed to help address the worldwide epidemic of chronic hepatitis C virus infection," said Dr Roger M Perlmutter, president, Merck Research Laboratories. "Our clinical program was designed to study a broad range of patients infected with the hepatitis C virus, including difficult-to-treat patients such as those with stage 4 or 5 chronic kidney disease. The approval of ZEPATIER is a testament to Merck's unwavering commitment to improving therapy for patients with hepatitis C virus infection, and we are eager to bring this innovation to patients and physicians in the United States." ZEPATIER was approved with a treatment duration of 12 or 16 weeks, depending on HCV genotype, prior treatment history and, for patients with GT1a infection, the presence of certain baseline NS5A polymorphisms. A 12-week, once-daily regimen is recommended for the vast majority of patients for whom ZEPATIER is indicated. Merck's broad clinical trial program supporting the efficacy of ZEPATIER included six studies in 1,373 patients with chronic HCV GT1 or GT4 infection. These studies assessed the rate of sustained virologic response 12 weeks after the completion of treatment with ZEPATIER (SVR12). The clinical development program for ZEPATIER enrolled diverse groups of HCV GT1- and GT4-infected patients, including treatment-naÃ¯ve patients and those who had failed prior therapy with peginterferon alfa(PegIFN) and RBV, as well as patients suffering with meaningful co-morbidities and health complications, such as compensated cirrhosis and HIV-1 co-infection. GT1-infected patients with severe renal impairment on hemodialysis and those who previously failed therapy with PegIFN and RBV in combination with an HCV NS3/4A protease inhibitor (boceprevir, simeprevir or telaprevir) also were studied. ]]> <![CDATA[Hottest Start-up: Soldiers against drug resistance terror]]> https://biospectrumindia.com/features/95/7997/hottest-start-up-soldiers-against-drug-resistance-terror.html https://biospectrumindia.com/features/95/7997/hottest-start-up-soldiers-against-drug-resistance-terror.html Fri, 29 Jan 2016 18:01:00 +0530 Established in 2014, Bugworks is a drug discovery start-up involved in finding novel biopharmaceutical assets in treating antibiotic-resistant bacterial infections, using its proprietary systems biology platform. The start-up is actually a spin-off of Cellworks, a ten-year-old company focused on designing therapeutics using simulations to screen studies and predicting clinical outcomes, thereby increasing success rates and reducing R&D development costs. Cellworks is said to be the first company in India to use systems biology to study drug-disease interactions, and solving key issues in cancer drug discovery. It is an amalgamation of diverse areas such as mathematics, simulation, biochemistry and pharmacology in studying tumors, enabling creation of personalized medicine for cancer. Located in California, USA, and Bangalore, India, it was funded by investments from Artiman Ventures and Sequoia Capital. The genesis of Bugworks began at Cellworks while the team started working on infection portfolio. In 2013, the Cellworks team wanted to focus its attention on a large unmet medical need with high mortality rates. Their quest pointed them towards hospital-acquired infections. These infections are picked up by people in hospitals through gram-negative bacterial contaminations, which are hard to kill and have greater drug resistance attribute. "Decades have passed by and drug resistant superbugs are becoming superior and smarter with higher mortality rates, with no available treatments to combat them effectively. Not many companies are working in this area, and we thought this would be the perfect stop for us to start," reveals Dr Anand Anandkumar, CEO, Bugworks, who also serves as the external director and chairman of the board of directors of the Cellworks' India operations. He says that patients are being bombarded with antibiotics for a certain period thereby bolstering the resistance rates causing a big void in finding new mechanisms fighting them. "Emerging countries are at the worst. India is a worst offender in the world. Antibiotic abuse happens in agriculture, poultry and medical stores because of their low-cost availability," he adds. Along with him, the company was co-founded by Dr V Bala Subramanian, serving as the president and Dr Santanu Datta as the chief scientific officer (CSO) of Bugworks, both of them hailing from a rich, two-decade-plus research experience at AstraZeneca India. While at AstraZeneca India, the former held major leading roles working on infection research and anti-bacterial drug discovery, the latter worked as a principal research scientist on infectious diseases with a focus on Malaria and Mycobacterium tuberculosis (MTB). Dr Anand continues, "The need is so bad because of the drug resistance in bacteria due to antibiotic abuse and lack of new drugs. The bugs have become used to existing drugs. There are not many drug discovery companies ready to invest in fighting the antibiotic-resistance." The last antibiotic widely used was Colistin, discovered in the 1950s. However, during the 70s, use of Colistin was stopped especially in the US because of its toxicity. "The last mechanism introduced for gram-negative bacteria was way back in the 60's. We have not had new antibiotic class for a long time," says Dr Bala Subramanian. Incubated at C-CAMP (Centre for Cellular and Molecular Platforms), Bugworks is located in Bangalore and Delaware, USA, employing close to 20 top-class professionals with diverse backgrounds. Bugworks' team also developed insilico model of MTB, and used it to identify new combinations for treating multidrug resistant tuberculosis (MDR) and extensively drug resistant tuberculosis (XDR-TB). Dr Bala explains, "The treatment for tuberculosis (TB) is a combination. We wanted to build a combination from all the existing available drugs in a rational manner. There are 18 different TB drugs, and we looked at 4 drug combinations, which led to 2 million combinations. This is where simulation comes to play. We built a computational model to probe all the 18 mechanisms and know the top combinations that can effectively arrest TB growth. We have had a successful collaboration with AstraZeneca in this regard, and now were able to identify 5 new drug combinations." The company has created a dynamic map of the bacteria, capable of exactly knowing where to block to stop its growth. "From that map, we can figure out where to block it with pinpointing accuracy," Dr Santanu voices. Dr Anand states that Bugworks will continue to work on TB but its focus will heavily be on hospital-acquired infections, and he says not much noise or awareness is made in this space. "We are looking for new mechanisms for antibiotics for gram-negatives, and new methods to prevent the formation of biofilms in medical devices," he notes. Biofilms are formed when microorganisms adhere themselves to the surface of objects, including medical devices. "In a way, we have a biopharmaceutical play, and potentially devices play too," says Dr Anand with excitement. In less than two years, Bugworks has bagged 4 grants - 1 international and 3 DBT-sponsored. "It has helped us with the cashflow in the company. We have won grants worth $300,000," he shares. The company, in 2015, was awarded as the 'Emerging Company of the Year' by ABLE (Association of Biotechnology Led Enterprises). At the moment, Bugworks has completed pre Series A round funding. "We will enter the market for Series A in about 12 months from now. The company has raised equity worth $2.3 million through angel investors," Dr Anand remarks. Bugworks is in in talks with large, world-class companies in the biopharmaceutical space for potential collaborations. "We are looking for collaborations with innovation-focused companies. Collaborations, for example, with big pharmas who can take our early proof-of-concept (PoC) and move up further. Our current collaborations are with universities, NCBS (National Centre for Biological Sciences) and a group in New York," opines Dr Anand. Dr Bala says that the company's expansion will purely depend on its partnerships. "It's too early to comment or forecast on our expansion. Firstly we want to take our offerings and make them available to population around the world. The 'where' and the 'how' depends on how we partner. Our products are not designed particularly for the Indian or Chinese markets. It's a global market out there." Dr Anand appreciates the start-up support offered by BIRAC (Biotechnology Industry Research Assistance Council). "We are proud to partner with BIRAC. They have been supportive of early-stage, high-risk and high-innovation companies with unique methodologies. The Government has been supporting very well, especially in the last 5 years. Without the DBT's support initially, Bugworks wouldn't exist today. The support was not just in terms of fundings but also the much-needed infrastructure as well," he expresses. According to Dr Anand, India has got talent on par with talent pool in Boston and Silicon Valley. "In the last few years, the ecosystem is getting stronger, compared to how it was 7 or 8 years ago. The only missing piece is we don't have good PEs, VCs or angels, who have the patience to put their money in this space. We have very few success stories in the country," he points. He emphasizes start-ups to have a strong, extraordinary team. "Everything boils down to the extraordinariness of the team. Up to series A, the funding purely depends on the strength of the team. It is good to have a 3 to 4-membered team from diverse backgrounds. Keep your eyes on the US markets, and having a founder who has good connections in the US is worth it. Entrepreneurs need to understand IPs, the problem they solve, its magnitude, the uniqueness of solution and the funding dynamics," he advices. He also adds that entrepreneurs need to have great patience and appetite for risk. "This is more like a marathon. At an individual level, being open to ideas and inputs coming in from all directions is important. One should be receptive to influences and possess tenaciousness. We have worked with very less or no salary at times. That's part of the risk appetite, or else it doesn't make sense to get into this game," Dr Anand clarifies. When it comes to the core team, Dr Bala says that it is not about the interplay of different skillsets. "We also bring in different emotional quotients, and a mix of optimism and pessimism as well. It is a heterogeneous group where we challenge each other. It's more than technical skillsets. It is also about emotional quotient," he mentions. For Bugworks, it took a year and almost 100 presentations to close its funding round. "Today investors are flocking towards food delivery and ecommerce start-ups. Nevertheless, we have a big opportunity at hand and seems very fulfilling scientifically, emotionally, socially, and financially. It's a social problem that we are solving. That's where it gets exciting," concludes Dr Santanu. ]]> <![CDATA[Dr Reddy's migraine injection wins FDA approval ]]> https://biospectrumindia.com/news/95/3497/dr-reddys-migraine-injection-wins-fda-approval-.html https://biospectrumindia.com/news/95/3497/dr-reddys-migraine-injection-wins-fda-approval-.html Fri, 29 Jan 2016 15:37:08 +0530 Dr Reddy's Laboratories has announced that the US Food and Drug Administration (US FDA) has approved ZEMBRACESymTouch (sumatriptan succinate) injection, a drug-device combination product intended for the treatment of acute migraine episodes, with or without aura, in adults who are inadequately managed with existing treatment regimens. ZEMBRACESymTouch is available as a prefilled, ready-to-use, single-dose disposable auto injector containing 3 mg of sumatriptan, a selective 5-HT1B/ID receptor agonist. The injection is intended to be given subcutaneously. "We are pleased to have received FDA approval for ZEMBRACESymTouch," said Mr Raghav Chari, executive vice president, proprietary products group at Dr Reddy's. He added, "ZEMBRACESymTouch is the first branded product in our Neurology portfolio. Migraine affects millions of patients. Many of these patients have busy lives and quick pain relief is critical to help them manage through their daily routines. In many cases, migraine episodes are accompanied by severe nausea, making it difficult to swallow and retain pills. ZEMBRACESymTouch is specifically designed for patients who may experience certain migraine episodes and for whom a pill may not be the right option." ZEMBRACESymtouch will be marketed in the United States by Promius Pharma, a wholly-owned specialty company of Dr Reddy's. "This is a major milestone for the company as we continue to bring innovative medicines to patients and physicians," said Mr G V Prasad, CEO and co-chairman, Dr Reddy's. ]]> <![CDATA[Hep B market growth to 2024 limited by low diagnosis and treatment rates]]> https://biospectrumindia.com/features/95/8131/hep-b-market-growth-to-2024-limited-by-low-diagnosis-and-treatment-rates.html https://biospectrumindia.com/features/95/8131/hep-b-market-growth-to-2024-limited-by-low-diagnosis-and-treatment-rates.html Fri, 29 Jan 2016 13:59:33 +0530 The global hepatitis B market, which is set to experience limited growth from $2.4 billion in 2014 to $3 billion by 2024, is being stymied by the persistence of low diagnosis and treatment rates, according to research and consulting firm GlobalData. The company's report identifies a number of factors that negatively impact hepatitis B treatment uptake, including the lack of an effective universal screening program for hepatitis B virus (HBV) infection, the low awareness of the disease prevalence among the general public and physicians, and the high cost of effective treatments. Dr Daian Cheng, GlobalData's Analyst covering Infectious Diseases, explains: "A significant reason why hepatitis B goes undetected in so many infected adults is the fact that most of them present as asymptomatic until the appearance of severe liver damage, such as fibrosis and cirrhosis. "This problem is exacerbated by the fact that there is no active universal screening program for chronic hepatitis B, and physicians may not always think of testing for this infection. As a result, the detection of hepatitis B relies largely on individuals, which is challenging when people are uneducated about the disease. Negative stigma and other societal barriers further complicate diagnosis. "While management guidelines for chronic hepatitis B recommend screening for the virus in high-risk populations, such as migrants from countries with high disease prevalence, the identification of new patients remains difficult." The cost of medical care can be a barrier to treatment access, particularly for low-income populations, which represent a substantial proportion of people living with chronic hepatitis B. In addition to the lack of ability to pay for treatment independently, these populations also tend to be poorly covered by medical insurance, and are reluctant to seek treatment. In addition, more affordable generic products of older antivirals, such as Epivir-HBV (lamivudine), are much more popular than newer branded drugs, but bear the heavy price of very high viral resistance. Dr Cheng notes: "Despite the high incentive among experts interviewed for this report to improve the efforts of identifying new patients and applying them with the most effective and safest drugs available, social changes will certainly be crucial to the improvement in diagnosis and treatment rates of chronic hepatitis B." ]]> <![CDATA[Aurobindo gains FDA approval for fungal infections tablets ]]> https://biospectrumindia.com/news/95/7628/aurobindo-gains-fda-approval-for-fungal-infections-tablets-.html https://biospectrumindia.com/news/95/7628/aurobindo-gains-fda-approval-for-fungal-infections-tablets-.html Fri, 29 Jan 2016 10:54:52 +0530 Aurobindo Pharma is pleased to announce that the company has received final approval from the US Food and Drug Administration (USFDA) to manufacture and market Voriconazole Tablets, 50 mg and 200 mg. This product is expected to be launched in Q4 FY15-16. The approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) VFEND Tablets, 50 mg and 200 mg of PF Prism CV(Prism). Voriconazole Tablets is used in the treatment of fungal infections for patients 12 years of age and older. The approved product has an estimated market size of $103 million for the twelve months ending November 2015 according to IMS. This is the 59th ANDA to be approved out of Aurobindo's Unit VII formulation facility in Hyderabad, India for manufacturing Oral Non-Antibiotic products. ]]> <![CDATA[Lily, Roche partner for Alzheimer's diagnostic ]]> https://biospectrumindia.com/news/95/6329/lily-roche-partner-for-alzheimers-diagnostic-.html https://biospectrumindia.com/news/95/6329/lily-roche-partner-for-alzheimers-diagnostic-.html Fri, 29 Jan 2016 10:54:11 +0530 Eli Lilly and Company has announced an arrangement to partner with Roche Diagnostics on its ongoing development of a commercially scalable cerebrospinal fluid assay for amyloid-beta 1-42. Together with tau tangles, the presence of amyloid in the brain is a key marker of Alzheimer's disease, a condition with no cure that is estimated to impact more than 7.4 million Americans by 2025. Improving the ability of practicing clinicians to detect evidence of amyloid is an important step in being able to effectively manage the disease. Currently, healthcare providers can find evidence of amyloid in the living brain through two methods: a cerebrospinal fluid (CSF) test and an amyloid brain positron emission tomography (PET) scan. Under this non-exclusive agreement, Lilly is responsible for certain milestone payments upon successful completion of key development objectives. Roche is responsible for the development, registration, and commercialization of the new test. "We are excited to partner with Roche Diagnostics on this important test," said Ms Phyllis Ferrell, vice president of Lilly's Alzheimer's disease platform. "We share the same commitment to providing people with Alzheimer's disease the best care possible, which includes detection as well as diagnosis and education." ]]> <![CDATA[Global SjÃ¶gren's Syndrome treatment market to double to $2.2 bn by 2024]]> https://biospectrumindia.com/features/95/7751/global-sjgrens-syndrome-treatment-market-to-double-to-2-2-bn-by-2024.html https://biospectrumindia.com/features/95/7751/global-sjgrens-syndrome-treatment-market-to-double-to-2-2-bn-by-2024.html Thu, 28 Jan 2016 18:03:08 +0530 The SjÃ¶gren's syndrome treatment market will experience impressive growth over the next decade, doubling from $1.1 billion in 2014 to $2.2 billion by 2024, driven primarily by the launch of Bristol-Myers Squibb's Orencia from 2021, according to research and consulting firm GlobalData. The company's latest report states that this increase, which is forecast across the seven Major Markets (7MM) of the US, Japan, the UK, France, Spain, Italy and Germany, represents a considerable Compound Annual Growth Rate (CAGR) of 7.2%. Dr Haylyn Wong, GlobalData's Senior Analyst covering Cardiovascular and Metabolic Disorders, says that Orencia (abatacept), the first biologic agent for the treatment of SjÃ¶gren's syndrome, is anticipated to launch across the 7MM by 2022. Dr Wong explains: "Orencia is currently in Phase III of development, and has so far demonstrated positive results in treating SjÃ¶gren's syndrome. A small open-label pilot study has shown that the drug significantly reduces disease activity, with most improvement seen in pain and fatigue scores. "GlobalData believes that Orencia will capture patient share from existing SjÃ¶gren's syndrome patients receiving systemic immunosuppressants and corticosteroids, and to a smaller degree from patients receiving antimalarial agents who are not adequately managed." While Orencia demonstrates great potential, the overall SjÃ¶gren's syndrome treatment pipeline is sparse and there are only a few products in early-stage development. Dr Wong explains: "Novartis has two agents in Phase II development, while MedImmune is developing a biologic in conjunction with Amgen called AMG-557/MEDI5872, which is in Phase IIa clinical trials, in addition to a second product called MEDI-4920 that is in Phase I development. "Despite the scarcity of innovative pipeline products, SjÃ¶gren's syndrome treatment market growth will also be driven by an increase in the prescribing of off-label biologic therapies, such as Genentech/Biogen's Rituxan (rituximab), while in the EU, ciclosporin ophthalmic solution is also expected to be adopted as an off-label agent for those patients with ocular dryness." ]]> <![CDATA[Glioblastoma treatment market to expand fivefold to $3.3 bn by 2024]]> https://biospectrumindia.com/features/95/6984/glioblastoma-treatment-market-to-expand-fivefold-to-3-3-bn-by-2024.html https://biospectrumindia.com/features/95/6984/glioblastoma-treatment-market-to-expand-fivefold-to-3-3-bn-by-2024.html Thu, 28 Jan 2016 18:02:07 +0530 The glioblastoma treatment market will increase fivefold from $659 million in 2014 to $3.3 billion by 2024, representing a rapid Compound Annual Growth Rate (CAGR) of 17.4%, according to research and consulting firm GlobalData. The company's latest report states that this meteoric rise, which will occur across the seven Major Markets (7MM) of the US, Spain, France, the UK, Italy, Germany and Japan, will primarily be due to the launch of new therapies for glioblastoma patients with high unmet needs. Dr Maxime Bourgognon, GlobalData's Analyst covering Oncology and Hematology, says: "Adults with glioblastoma have some of the highest levels of unmet need of any cancer patients. Despite progress having been made in treating the disease, survival rates remain low. "Although glioblastoma is a rare disease, such high levels of unmet need in the market have created ample opportunities for players with effective therapies. However, developing drugs which effectively treat glioblastoma has proved exceedingly challenging to date, predominantly due to the presence of the blood-brain barrier, which prevents many drugs from entering the brain and attacking the tumor." GlobalData believes that current pipeline drugs offer potential solutions to this complex obstacle, and has identified Bristol-Myers Squibb's immunotherapy Opdivo (nivolumab) as a particular contender to become the primary standard of care by 2024. Dr Bourgognon explains: "Immunotherapies have shown significant efficacy in other oncology indications, and as they affect the tumor microenvironment rather than directly targeting the tumor, they make attractive candidates for glioblastoma treatments. "Currently, Avastin dominates the market, working by inhibiting angiogenesis and disrupting the blood-brain barrier, which in turn leads to tumor starvation. Patients refractory to the drug, however, have scant treatment options, and Opdivo addresses this." As with the rest of the 7MM, growth will be driven by the introduction of new drugs such as Opdivo. However, higher pricing of the drug in Japan will result in the country's even faster growth rate, according to GlobalData. ]]> <![CDATA[BioAsia forges Norway as strategic partner for its 13th edition]]> https://biospectrumindia.com/news/95/7741/bioasia-forges-norway-as-strategic-partner-for-its-13th-edition.html https://biospectrumindia.com/news/95/7741/bioasia-forges-norway-as-strategic-partner-for-its-13th-edition.html Thu, 28 Jan 2016 18:01:50 +0530 BioAsia, Asia's largest Biotechnology and Life-sciences forum today announced that Norway will be the country partner for the 13th Edition of BioAsia which will be held from 8th - 10th February at the Hyderabad International Convention Center HICC. Positioned to be on a much larger scale this year, BioAsia is a unique platform enabling convergence of various stakeholders from Healthcare, Biotech, Pharma, Life-Sciences, IT, Academia and Startups to connect the dots under the theme Leveraging India to succeed globally, BioAsia 2016 through this strategic partnership will aim to both build professional relationships and maximize exposure for Norwegian companies in India and vice versa. The partnership will build a network that can facilitate both business and research collaborations between Norway and India.Norway's delegation at BioAsia aims to create more opportunities for Norwegian companies to connect and collaborate with the Indian Biotech and Life sciences industry. Norwegian companies are also looking to approach local partners to enhance their reach and presence in the Indian market through BioAsia. Commenting on the development, Mr. Shakthi Nagappan, CEO, BioAsia said, "We are glad to have Norway as our Country Partner for this year's edition. We are sure that the deliberations between both the countries during BioAsia will materialize into beneficial bi-lateral trade opportunities for both and further the ongoing cooperation. "The 13th edition of this leading industry event will see participation from a 10 member delegation which will include regulatory body representatives, industry captains, high profile speakers, etc from Norway. "The Indian biotech and Life sciences market is an attractive opportunity for any company that produces products or solutions in an intrinsically global field as health. In addition India has a cost advantage, a skilled workforce, excellent opportunities in the R&D area, and a heavy technology focus. Norway has proven strengths in areas like medical technology, health IT, NCDs, immunotherapy and oncology, and telemedicine, which we believe will be of great interest and benefit to the Indian healthcare market. BioAsia over the years has emerged as one of the largest Bio Business forums in the world. We believe that our partnership with BioAsia 2016 will result into meaningful collaboration with stakeholders and will open up more trade opportunities for the Indian healthcare sector as well" said Mr. Helge Tryti, Director, Innovation Norway (India) Mr. Helge Tryti further highlighted key pointers about the Norwegian Biotech and healthcare sector, "The Biotech sector in Norway is largely dominated by small and innovative startups. The domains more prevalent in Norway are healthcare (diagnostics, therapeutics and vaccine), food, agriculture and marine biotech, environment and bio processing. Biotech is marked as one an important part of Norway's future economy. Norway has strong research in biomedical, marine and agricultural biotechnology, and the marine resources provide interesting opportunities to the Indian players.We are increasingly implementing new technological solutions in the healthcare sector in order to keep up with the high demand for healthcare services. There are a number of opportunities for Indian companies that deliver solutions in segments such as telemedicine, elderly care, diagnostics, chronic care and treatment, treatment for NCDs etc." BioAsia 2016 will provide the right global platform for the country partners to interact with the industry leaders and key stakeholders. The key elements of these interactions will be breakfast meetings, b2b partnering meetings, delegations and trade body level meetings. ]]> <![CDATA[Adisseo, Novozymes launch their first probiotic for poultry]]> https://biospectrumindia.com/news/95/7505/adisseo-novozymes-launch-their-first-probiotic-for-poultry.html https://biospectrumindia.com/news/95/7505/adisseo-novozymes-launch-their-first-probiotic-for-poultry.html Wed, 27 Jan 2016 16:57:09 +0530 Adisseo and Novozymes, two global leaders in the animal nutrition and feed additive industry, today announced the launch of their probiotic for poultry, Alterion, on the U.S. market as well as in a number of countries in the Middle East and South East Asia. Alterion has been developed from a unique strain of Bacillus subtilis, a naturally-occurring bacterium found in soil. Added to feed, it allows farmers to better control gut health of their animals, it limits development of unwanted bacteria in the animal's digestive tract, and it optimizes feed conversion by 2 to 2.5 percent, meaning less feed consumed to raise an animal. The launch is the result of an extensive collaboration. Novozymes used its expertise in biotechnology to perform in-vitro testing and is responsible for development and production of Alterion. Adisseo, an expert in animal sciences, performed in-vivo testing and manages marketing and sales. "Global trials have validated the performance and mode of action of Alterion and trial customers are very excited about the results," says Mr Jean-Marc Dublanc, CEO of Adisseo. "This confirms that the product is ready for market and it will be gradually rolled out on a global scale. We are convinced that it will be a valuable tool for customers looking for a sustainable and economical solution to meet regulatory challenges and consumer-driven curbs on use of antibiotic growth promoters." "The combined scientific expertise of our companies has made it possible to develop this consistently high-performing probiotic which improves both gut health and feed conversion and as such, can help reduce antibiotic usage in poultry," says Ms Helle Warrer Poulsen, Vice President of Animal Health & Nutrition at Novozymes. "There is a clear move towards more sustainable animal farming methods. Alterion can help the industry on this journey." For decades, antibiotics have been widely used in animal production to help livestock grow. Now more and more countries are restricting use of antibiotics for growth promotion as part of strategies to prevent development of resistance to antibiotic treatments in humans. Probiotics are naturally occurring live microbes that stabilize the gut flora of poultry, pigs and other animals when ingested. They can improve animal health, growth rate and feed utilization, thereby saving resources and improving sustainability of the animal farming industry. Adisseo and Novozymes estimate the probiotics market at EUR 200-300 million and 8-10 percent annual growth. The partners strive to become key players in probiotics for animals and accelerate the expansion of this fast-growing market. ]]> <![CDATA[Venaxis announces transaction with Strand ]]> https://biospectrumindia.com/news/95/7504/venaxis-announces-transaction-with-strand-.html https://biospectrumindia.com/news/95/7504/venaxis-announces-transaction-with-strand-.html Wed, 27 Jan 2016 16:56:46 +0530 Venaxis is an in vitro diagnostic company which has been focused on the clinical development and commercialization of its APPY1 Test, the company's rapid blood-based test for appendicitis. Strand LS is a privately-held, global genomics and bioinformatics company. Strand LS operates clinical reference labs in the US through its wholly owned subsidiary Strand Genomics (Strand U.S.) and directly in India, providing testing and lab services in India and other world-wide markets. Strand LS has commercialized a next generation sequencing (NGS) based, targeted, multi-gene, pan-cancer diagnostic panel in select international markets and has engaged in initial commercialization activities in the United States. Assuming participation by 100% of the Strand LS shareholders, the effect of the transaction will be that Strand LS shareholders and the employees and directors who are option-holders in Strand LS will own directly and beneficially approximately 68% of the combined enterprise and the current shareholders of Venaxis will own approximately 32%. Due to Indian tax and financial regulations, the transaction is being structured as purchases, by Venaxis, of the Strand LS shares from the Strand LS shareholders, followed by an immediate re-investment of those sale proceeds, by the Strand LS shareholders, into Venaxis Common Stock. To comply with certain long-term holding period requirements under Indian tax law, the transaction is expected to be completed in two closings. The first closing will occur upon receipt of the necessary approvals from the Venaxis shareholders, receipt of all other required approvals and satisfaction of identified closing conditions. The second closing will occur approximately six months later. At each closing, Venaxis will enter into resale registration rights agreements with the Strand LS shareholders participating in such closing. The boards of each company have unanimously approved the transaction, however this transaction is subject to Venaxis shareholder approval. At the first closing, Venaxis will own a majority of the shares of Strand LS, will change its name to Strand Life Sciences, and will change its NASDAQ trading symbol. As part of the first closing, following Venaxis shareholder approval, a Venaxis subsidiary will enter into an asset purchase agreement with Strand U.S. in which it will acquire substantially all of the assets and liabilities of Strand U.S. in exchange for cash consideration paid to Strand U.S. Advancing to the execution of the agreements with Strand LS, its shareholders and Strand U.S. represents the outcome of an extensive strategic process initiated by Venaxis in early 2015. Venaxis has also commenced, and expects to continue to attempt to locate a partner or other third-party interested in advancing development and or commercial activities of the Venaxis appendicitis portfolio. Aligning Strand Life Sciences' proven technological expertise in genomic profiling, bioinformatics and data curation with Venaxis' financial resources, NASDAQ public listing and key management personnel provides an opportunity for Strand Life Sciences to continue to commercialize its global business model towards what is believed to be a valuable enterprise for the combined shareholders. Following approval by the Venaxis shareholders and satisfaction of the other closing conditions, at the first closing, Dr. Vijay Chandru, the co-founder and current Executive Chairman of Strand LS, will serve as Executive Chairman of the combined company's Board of Directors, Steve Lundy will become the Chief Executive Officer of the combined company and Jeff McGonegal will continue as CFO. The initial combined board will consist of seven members with four from Strand LS and three from Venaxis. Commenting on the transaction, Dr. Vijay Chandru said, "On behalf of the Strand LS shareholders, we believe that this transaction represents an attractive opportunity for Strand Life Sciences, as an agile innovator in clinical genomics, to combine forces with Venaxis, a public company in the United States with experienced executives and board members to help it rapidly expand market adoption of StrandAdvantageTM and other future product offerings." "We are pleased to announce this transaction and are excited by the significant opportunity we believe it presents for shareholders of Venaxis and Strand LS," said Mr. Steve Lundy, Chief Executive Officer of Venaxis, Inc. "The combined company will benefit from Strand Life Sciences' 15 year successful history of technological expertise in genomic profiling, bioinformatics and data curation. Our initial focus will be to improve patient outcomes through the use of the StrandAdvantage pan-cancer gene panel, which was commercially launched in the United States in 2015. The combined company is expected to be focused on the continued commercialization of StrandAdvantage, as well as the development of additional oncology-related diagnostics." Raymond James & Associates, Inc. and Oppenheimer & Co. Inc. are acting as joint financial advisors to Strand LS and Baker & Hostetler LLP is acting as legal counsel for Strand LS. Ballard Spahr LLP is acting as legal counsel to Venaxis. ]]> <![CDATA[Industry, Academia come together to establish translational research fund]]> https://biospectrumindia.com/news/95/7374/industry-academia-come-together-to-establish-translational-research-fund.html https://biospectrumindia.com/news/95/7374/industry-academia-come-together-to-establish-translational-research-fund.html Wed, 27 Jan 2016 10:42:45 +0530 This pioneering new consortium aims to convert outstanding academic science from the three universities into innovative medicines for a broad range of diseases. The fund will bring academic preclinical research through to the stage of development stage at which it can either be taken forward by one of the industry members following an internal bidding process or be out-licensed. Each industry member will contribute £10 million over 6 years to the venture and may provide in-house expertise and additional resources to assist with the commercial evaluation and development of projects. The Tech Transfer Office (TTO) for each university (Imperial Innovations plc, Cambridge Enterprise and UCL Business) is each contributing a further £3.3 million. An independent Drug Discovery Team of ex-industry scientists will be employed by the Fund to work with the universities and their TTOs in identifying and shaping projects at an early stage, optimizing the chances of their onward development. The Apollo Investment Committee, comprising representatives from each member organisation, will make all investment decisions. All therapy areas and all modalities (including small molecules, peptides, proteins, antibodies, cell and gene therapies) are in scope. For projects that become successful therapies, the originating university and TTO will receive 50 percent of future commercial revenues or out-licensing fees and the remaining 50 percent will be divided amongst all Apollo members. Dr Mene Pangalos, executive vice president of Innovative Medicines and Early Development Biotech Unit at AstraZeneca, said, "We're delighted to be part of The Apollo Therapeutics Fund, which brings together the complementary skills of academia and business. This partnership is another example of our commitment to being an integral part of the research community in the UK and takes a highly innovative approach to sharing both the risks and the rewards of applied research. I am confident that by working with scientists from world leading universities in the UK, we will help convert ground breaking science into important new treatments for patients." ]]> <![CDATA[Two Doctors in this year's list of Padma awardees]]> https://biospectrumindia.com/news/95/7934/two-doctors-in-this-years-list-of-padma-awardees.html https://biospectrumindia.com/news/95/7934/two-doctors-in-this-years-list-of-padma-awardees.html Mon, 25 Jan 2016 16:53:13 +0530 Dr Viswanathan Shanta has been awarded Padma Vibhushan. Dr Shanta is a prominent cancer specialist and the chairperson of Adyar Cancer Institute, Chennai. Her career has included organizing care for cancer patients and research in the prevention and cure of the disease. The Padma Vibhushan is the second-highest civilian award of the Republic of India, the award is given for the exceptional and distinguished service. Prof D Nageshwar Reddy has been awarded the Padma Bhushan award. Dr Reddy is the chief of Gastroenterology and Therapeutic Endoscopy, Asian Institute of Gastroenterology, based in Hyderabad. The Padma Bhushan is the third highest civilian award in the Republic of India. ]]> <![CDATA[Despite unmet needs, pulmonary arterial hypertension therapy market to hit $4.75 bn by 2024]]> https://biospectrumindia.com/features/95/3286/despite-unmet-needs-pulmonary-arterial-hypertension-therapy-market-to-hit-4-75-bn-by-2024.html https://biospectrumindia.com/features/95/3286/despite-unmet-needs-pulmonary-arterial-hypertension-therapy-market-to-hit-4-75-bn-by-2024.html Mon, 25 Jan 2016 12:57:53 +0530 The Pulmonary Arterial Hypertension (PAH) therapeutics market will experience modest growth from $3.45 billion in 2014 to $4.75 billion by 2024, representing a Compound Annual Growth Rate (CAGR) of 3.2%, according to research and consulting firm GlobalData. The company's latest report states that the increase in PAH treatment sales, which will occur across the seven major markets of the US, France, Germany, Italy, Spain, the UK, and Japan, will be driven by new drug launches, the increased use of double and triple combination therapies, and patient assistance programs by manufacturers. Dr Lakshmi Dharmarajan, GlobalData's Senior Analyst covering Cardiovascular and Metabolic Disorders, says that despite these developments and growth in the PAH arena, significant unmet needs will remain by 2024, the most crucial of which is to find a cure for the fatal disease. Dr Dharmarajan explains: "While there are currently 12 marketed PAH therapies available, they only serve to slow disease progression. There is no marketed drug that addresses the underlying disease mechanism and targets to cure patients. "The main challenges in developing curative or stabilizing therapies come from a lack of understanding of the disease mechanism. This is not helped by the fact that most companies in the field are focusing their attention on reformulating existing PAH drugs and enhancing patient convenience, rather than improving efficacy." The analyst adds that there is a great need to develop biomarkers and assays that could be used to predict patient response upfront and make treatment more personalized. However, there are no ongoing efforts to address this need in the PAH therapeutics market. In terms of what the PAH treatment pipeline does have to offer, there are only two drugs in late-stage clinical development. Dr Dharmarajan continues: "The more promising of the two late-stage pipeline PAH drugs is Actelion's Uptravi, a first-in-class prostacyclin IP receptor agonist with a favorable clinical efficacy and safety profile. Uptravi was recently launched in the US in January 2016 and is estimated to be the highest revenue generator of the PAH market at the end of the forecast period, recording near-blockbuster sales of $996 million in 2024. "The other Phase III candidate, Beraprost sodium 314d, does not demonstrate as much potential due to its lack of clinical superiority over other existing prostacyclin-based therapies." GlobalData believes that pharmaceutical companies should address unmet needs by focusing their attention on PAH-specific mechanisms which, although wrought with a high risk of failure, could potentially lead to innovative and effective disease-modifying treatments. ]]> <![CDATA['Small Cell Lung Cancer Treatment to be worth $2.29 billion by 2024']]> https://biospectrumindia.com/news/95/3108/small-cell-lung-cancer-treatment-to-be-worth-2-29-billion-by-2024.html https://biospectrumindia.com/news/95/3108/small-cell-lung-cancer-treatment-to-be-worth-2-29-billion-by-2024.html Mon, 25 Jan 2016 11:06:51 +0530 The Small Cell Lung Cancer (SCLC) treatment market will rise dramatically from $198 million in 2014 to $2.29 billion by 2024, representing a high Compound Annual Growth Rate (CAGR) of 27.7 percent, according to research and consulting firm GlobalData. The company's latest report states that such impressive growth, which will occur across the seven major markets of the US, France, Germany, Italy, Spain, the UK, and Japan, will primarily be driven by the launch of premium-priced therapies, including anti-PD-1 and anti-CTLA-4 immunotherapies and targeted agents. Dr Volkan Gunduz, GlobalData's Analyst covering Oncology and Hematology, says novel SCLC therapies will experience strong and rapid adoption during the forecast period in combination with generic, chemotherapy-only regimens in the early lines of therapy, and extend the number of lines of treatment available for patients. Dr Gunduz explains, "The first immunotherapy to market will be the cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) inhibitor Yervoy. This drug is being developed by Bristol-Myers Squibb and will be launched in 2016 across the 7MM. Yervoy will achieve blockbuster status in the SCLC therapeutics space by 2024, driven by the combination of its premium price and anticipated dosing at a high concentration in combination with platinum-etoposide in extensive-stage SCLC." GlobalData's report also states that SCLC treatment sales will also be bolstered by an increase in rates of the disease across the five European markets (5EU) and Japan, at a CAGR of 1.49 percent over the forecast period. He added,"While smoking is by far the leading risk factor for lung cancer and is still a common practice in Eastern Europe and in developing countries, disease incidence is expected to plateau by 2024. This will occur as the 5EU and Japan follow in the footsteps of the US, where a reduction in cigarette smoking has caused SCLC incidence rates to decrease considerably over the last three decades. In this way, although the SCLC treatment market will thrive in the short term, its impressive growth may not continue beyond this point." ]]> <![CDATA[Global pharmaceutical industry calls on governments to work with them to beat the rising threat of drug resistance]]> https://biospectrumindia.com/news/95/7841/global-pharmaceutical-industry-calls-on-governments-to-work-with-them-to-beat-the-rising-threat-of-drug-resistance.html https://biospectrumindia.com/news/95/7841/global-pharmaceutical-industry-calls-on-governments-to-work-with-them-to-beat-the-rising-threat-of-drug-resistance.html Fri, 22 Jan 2016 14:21:23 +0530 More than 80 leading international pharmaceutical, generics, diagnostics and biotechnology companies, as well as key industry bodies, have come together to call on governments and industry to work in parallel in taking comprehensive action against drug-resistant infections - so-called 'superbugs' - with a joint declaration launched today at the World Economic Forum in Davos, Switzerland. The statement sets out for the first time how governments and industry need to work together to support sustained investment in the new products needed to beat the challenges of rising drug resistance. The Declaration on Combating Antimicrobial Resistance - drafted and signed by 85 companies and nine industry associations across 18 countries- represents a major milestone in the global response to these challenges, with commercial drug and diagnostic developers for the first time agreeing on a common set of principles for global action to support antibiotic conservation and the development of new drugs, diagnostics, and vaccines. The industry is calling on governments around the world to now go beyond existing statements of intent and take concrete action, in collaboration with companies, to support investment in the development of antibiotics, diagnostics, vaccines, and other products vital for the prevention and treatment of drug-resistant infections. In particular, the Declaration supports a continuation of efforts towards improved conservation of antibiotics, including a call for improved uptake of rapid point-of-care diagnostics to improve how antibiotics are prescribed, and changes to incentive structures within health systems that directly reward doctors, pharmacists and veterinarians for prescribing antibiotics in greater volumes. In what the Review on Antimicrobial Resistance recognizes to be a notable step for the industry, the signatory companies call on governments to work with them to develop new and alternative market structures that provide more dependable and sustainable market models for antibiotics, and to commit the funds needed to implement them. These mechanisms are needed to provide appropriate incentives (coupled with safeguards to support antibiotic conservation) for companies to invest in R&D to overcome the formidable technical and scientific challenges of antibiotic discovery and development. These include mechanisms to ensure that, where appropriate, the pricing of antibiotics more adequately reflects the benefits they bring; and novel payment models that reduce the link between the profitability of an antibiotic and the volume sold. An integral part of these models is a reduced need for promotional activity by companies. As well as calling for continued progress by governments on these fronts, the Declaration sets out a commitment to further action on drug resistance by its signatories, which the Review warmly welcomes. These span across three broad areas: Reducing the development of drug resistance. The companies commit to encouraging better and more appropriate use of new and existing antibiotics, including through work that supports the antibiotic stewardship principles set out by the World Health Organization (WHO) Global Action Plan on antimicrobial resistance (AMR), and via improved education of clinicians. This support extends to promoting more judicious use of antibiotics in livestock, as part of a 'one health' approach. Increasing investment in R&D that meets global public health needs. Recognizing the need to increase research into new antibiotics, diagnostics, vaccines and other alternative treatments, the companies commit to a continuation and extension of collaborative initiatives between industry, academia and public bodies to improve how R&D in the field is done and provide greater opportunities for the scientific barriers to antibiotic discovery to be overcome. Improve access to high-quality antibiotics for all. In light of the gaps that remain in global access to our existing antibiotics and vaccines, and the importance of ensuring that new generations of products are available to all those who need them, the signatories commit to supporting initiatives aimed at ensuring affordable access to antibiotics in all parts of the world, at all levels of income. By bringing together such a wide range of companies in this unprecedented way, the Declaration provides a valuable roadmap to guide further collaborative efforts between industry, governments and NGOs in the global fight back against AMR. The Review will continue to work to drive progress towards a series of key international milestones in 2016 - including likely discussions on AMR at the UN General Assembly and as part of China's G20 programme in the autumn - and in support of progress against the WHO Global Action Plan on AMR. The Declaration will be updated every two years, to take account of the evolving global landscape of AMR and changing challenges and priorities. It remains open to accept new signatory companies and bodies at any time, with a complete list maintained on the Review on AMR's website. ]]> <![CDATA[NATCO announces licensing agreement for Daclatasvir ]]> https://biospectrumindia.com/news/95/7840/natco-announces-licensing-agreement-for-daclatasvir-.html https://biospectrumindia.com/news/95/7840/natco-announces-licensing-agreement-for-daclatasvir-.html Fri, 22 Jan 2016 12:04:48 +0530 Natco Pharma has announced that it has signed a nonexclusive, royalty free licensing agreement with the Medicines Patent Pool (MPP) and Bristol-Myers Squibb to manufacture and sell generic versions of Bristol-Myers Squibb's chronic hepatitis C medicine - Daclatasvir Dihydrochloride (Daclatasvir). Daclatasvir, discovered and developed by Bristol-Myer Squibb, is the first-in-class NS5A inhibitor used in combination with Sofosbuvir for the treatment of patients with chronic hepatitis C virus (HCV)genotype 3 infection. Compared to other treatment options, this combination not only increases the cure rate, but is also regarded as a valuable treatment option in some of the difficult-to-treat HCV patient subsets. Natco will market generic Daclatasvir under its own brand NATDAC, and through its strategic partners in India. This agreement allows Natco to expand access to these chronic hepatitis C medicines in 112 developing countries. Under the license, Natco can set its own price for the generic products it produces. ]]> <![CDATA[MPP signs first sub-licenses for Hep C drug]]> https://biospectrumindia.com/news/95/8065/mpp-signs-first-sub-licenses-for-hep-c-drug.html https://biospectrumindia.com/news/95/8065/mpp-signs-first-sub-licenses-for-hep-c-drug.html Fri, 22 Jan 2016 12:04:32 +0530 The Medicines Patent Pool (MPP) announced its first round of sub-licenses for the generic production of Bristol-Myers Squibb's daclatasvir, a novel direct-acting antiviral that is proven to help cure multiple genotypes of the hepatitis C virus. Generic companies Cipla, Emcure, Hetero and Natco have signed non-exclusive, royalty free agreements with Bristol-Myers Squibb and the MPP to produce and sell daclatasvir in 112 low- and middle-income countries. The Medicines Patent Pool is a United Nations-backed public health organization working to increase access to HIV, viral hepatitis C and tuberculosis treatments in low- and middle-income countries. The sub-licenses follow MPP's announcement of its first hepatitis C licensing agreement, signed with Bristol-Myers Squibb in November 2015, and mark the first time that generic manufacturers have worked through a non-profit, public health organization to increase access to new hepatitis C medicines for developing world patients. Between 130 and 150 million people worldwide are estimated to have hepatitis C. The vast majority lives in low- and middle-income countries. Daclatasvir, discovered and developed by Bristol-Myers Squibb, is the first-in-class NS5A inhibitor used in combination with sofosbuvir for the treatment of patients with chronic hepatitis C virus (HCV) genotype 3 infection. Compared to other treatment options, this combination not only increases the cure rate, but is also regarded as a valuable treatment option in some of the difficult-to-treat HCV patient subsets. "Given the burden of hepatitis C, MPP worked quickly to forge agreements with generic companies," said Mr Greg Perry, Executive Director of the MPP. "Cipla, Hetero and Emcure are long-term partners working with us to develop generic HIV antiretrovirals. We welcome Natco, a new collaborator, to the MPP and hope to have other companies on board as well." MPP is assessing applications from several other companies and expects to grant further sub-licenses soon. The MPP licence allows generic manufacturers to develop fixed-dose combinations that offer the potential to treat all of the six major genotypes of hepatitis C (HCV). Daclatasvir, in combination with sofosbuvir, for example, produces high cure rates after 12 weeks of treatment, with recent Phase III studies demonstrating that the regimen could cure up to 100% of HCV patients depending on genotype and stage of liver disease. Natco is an India-based pharmaceutical company with five manufacturing facilities throughout the country and is one of the first generic companies to have India's Drug Controller General's approval to market the hepatitis C drug in the country. "Natco is committed to making affordable drugs available in developing countries. Daclatasvir combinations offer valuable treatment choices, including a potential pan-genotypic option. We look forward to collaborating with MPP to improve access to these medicines in India and elsewhere," said Mr Rajeev Nannapaneni, Vice Chairman & CEO. Cipla is a global pharmaceutical company with more than 1,500 products across various therapeutic areas. With a strong presence in HIV, the company holds several MPP sub-licenses for key antiretrovirals, including dolutegravir and tenofovir alafenamide. "We are pleased to once again work with the MPP to bring new classes of drugs to people who need them the most in developing countries," said Dr Jaideep Gogtay, Chief Medical Officer of Cipla. "Pan-genotypic daclatasvir regimens are crucial in resource-limited countries where access to genotype testing is limited." "It has been a pleasure working with the Medicines Patent Pool that has recently included hepatitis C into its focus areas. This licence will help us distribute daclatasvir to low- and middle-income countries at affordable prices," said Mr Vik Thapar, Head of Strategy, Emcure, one of the first generic companies to sign a licence with MPP for HIV antiretrovirals in 2012. Hetero, one of India's leading generic pharmaceutical companies, also signed an MPP licence agreement to produce daclatasvir. "Hetero is pleased to enter in the licensing agreement with MPP to produce daclatasvir for low- and middle-income countries," said Mr Bhavesh Shah, Director, International Marketing for the company. "The MPP has been a valued partner in our work to develop MPP-licensed HIV medicines and we welcome the opportunity to work on improving the standard of care and treatment for hepatitis C." Through its innovative business model, the MPP partners with industry, civil society, international organisations, patient groups and other stakeholders to prioritize, forecast and license needed medicines and pool intellectual property to encourage generic manufacture and the development of new formulations. To date, the MPP has signed agreements with six patent holders for twelve HIV antiretrovirals and for one hepatitis C direct-acting antiviral. Its generic partners have distributed more than three billion doses of low-cost medicines to 117 countries. The MPP was founded and remains fully funded by UNITAID. ]]> <![CDATA[Research paper on feather keratins evaluated number one]]> https://biospectrumindia.com/news/95/7838/research-paper-on-feather-keratins-evaluated-number-one.html https://biospectrumindia.com/news/95/7838/research-paper-on-feather-keratins-evaluated-number-one.html Fri, 22 Jan 2016 12:04:16 +0530 A research paper on keratinase and immune status published by the scientists from Annamalai University has been rated 1st among top 20 articles published during 2008 and till date, selected by BIOMEDICAL LIBRARY. The research paper titled 'Industrial application of keratinase and soluble proteins from feather keratins' published by Dr B Deivasigamani and Dr KM Alagappan of Centre for Advanced Studies in Marine Biology, Annamalai University was published in the November 2008 issue of the journal, Journal of Environmental Biology. In the paper, the researchers have shown how to degrade the poultry feather wastes (insoluble protein) to soluble protein. The crude protein from feather was found to be of high nutrient value and could be used as animal feed for livestock and fish feed in aquaculture. BioMedLib Search Engine takes query and finds the best responses among millions of biomedical articles in the National Library of Medicine's MEDLINE database. ]]> <![CDATA[Syngene Q3 profit up 31%; revenue up 23%]]> https://biospectrumindia.com/news/95/4031/syngene-q3-profit-up-31-revenue-up-23.html https://biospectrumindia.com/news/95/4031/syngene-q3-profit-up-31-revenue-up-23.html Fri, 22 Jan 2016 11:38:10 +0530 Biocon's contract research arm Syngene recorded Rs 281 crore revenue for the third quarter ended December 31, 2015 with a year on year growth of 23 percent. For the same period, company recorded Rs 51 crore profit with 31 percent increase over previous corresponding period. Commenting on the performance, Mr. Peter Bains, Executive Director and Chief Executive Officer - Syngene International Limited said, "Our Q3 results for FY16 saw a growth of 23% in revenues on the back of a sustained performance by all of our three business verticals - dedicated centres, discovery services as well as development & manufacturing services. This has helped us deliver revenues of Rs. 779 Cr. in 9MFY16, reflecting a YoY growth of 26%. I am also pleased to inform that we have successfully cleared another USFDA audit, which occurred in Q3 FY16. Our key capital investments are on track. The phase I of our new research centre is nearing completion, and will add significant capacities underpinning future growth. We continue to enhance and expand our service offerings to align with growing client requirements. The growth in Q3 FY16 was broad based across these three verticals, while being especially strong in the chemical development and discovery biology services. During the quarter, the company had one USFDA inspection of clinical development facility, which was successfully cleared with no 483s or major observations. Syngene has now successfully cleared five USFDA audits within the last three years. The phase I of Syngene Research Centre, comprising of 50,000 sq. ft. lab space, is scheduled to be commissioned in Q1 FY17. When fully commissioned, this centre will be a 200,000 sq. ft. versatile, state-ofthe-art research facility and will support integrated discovery programs in chemistry and biology. Other ongoing investments in various additional infrastructure are progressing on track and will be commissioned in the near to mid-term. ]]> <![CDATA[Biocon Q3 net profit up 13% at Rs 103 Cr]]> https://biospectrumindia.com/news/95/7836/biocon-q3-net-profit-up-13-at-rs-103-cr.html https://biospectrumindia.com/news/95/7836/biocon-q3-net-profit-up-13-at-rs-103-cr.html Fri, 22 Jan 2016 11:25:33 +0530 Bangalore based Biocon reported consolidated net profit of Rs. 103 crore for the third quarter of 2015-16, registering growth of 13 per cent year-on-year but decline of 66 percent quarter-on-quarter. The company's revenue stood at Rs. 857 crore for the same period, witnessing growth of 10 percent year on year. During the quarter Biocon's R&D spend was at Rs 68 crore grew by 45 percent reflecting progress of its biosimilars and novel programs.Biocon continues to cross critical milestones in global Phase III clinical trials of Biosimilars Trastuzumab, Pegfilgrastim, Adalimumab and Insulin Glargine.Branded Formulations business strengthened company's Virology portfolio with the launch of Cimivir-L, a once-a-day oral therapy for Hepatitis C, in India. Commenting on the quarterly performance and highlights, Chairperson and Managing Director, Kiran Mazumdar-Shaw stated:"Biocon's four most advanced biosimilar and generic insulin programs, Insulin Glargine, Trastuzumab, Pegfilgrastim and Adalimumab, continue to cross critical clinical milestones and are on track for regulatory filings in US & Europe in CY2016. These filings are likely to provide us an early mover advantage in an addressable US$30 Billion market. The progress made in our biosimilars and novel programs is reflected in the increase in R&D spends this quarter to Rs 68 crore. Excluding profit contribution from Syngene, Biocon's net profit this quarter has increased by 28% y-o-y despite a 45% jump in R&D spends and a significant increase in tax. This reflects a marked improvement in the quality of our earnings led by better realizations from biosimilars and immunosuppressants in emerging markets. Syngene, our research services company, has delivered yet another strong quarter both in terms of revenues and profits." ]]> <![CDATA[Albumedix spun out of Novozymes]]> https://biospectrumindia.com/news/95/7798/albumedix-spun-out-of-novozymes.html https://biospectrumindia.com/news/95/7798/albumedix-spun-out-of-novozymes.html Fri, 22 Jan 2016 11:11:12 +0530 Novozymes announced it has separated its biopharma activities into an independent company called Albumedix. The new company will be fully owned by Novozymes. Albumedix will be led by CEO Mr Peter Rosholm, who previously headed Novozymes' Biopharma business. The leadership team will report to an independent board consisting of three directors from the pharmaceutical industry and two representatives from Novozymes. The Chairman of the Board, Dr Donald deBethizy, brings more than 15 years of experience in managing and financing life science related technologies, and has played a key role in building and advising several life science companies. "I see a promising future for Albumedix, and together with Dr deBethizy and the rest of the team I look forward to expanding our role in the pharmaceutical industry. With our heritage, expertise in albumin, and skilled employees, we have a strong foundation for developing superior biotherapeutics for patients," said Mr Peter Rosholm. Albumedix will be headquartered in Lyngby, Denmark, with R&D and production facilities in Nottingham, UK. The company will employ approximately 100 people. Novozymes retains full ownership of Albumedix and the newly created company's financial results will continue to be consolidated into Novozymes' reporting. The formation of Albumedix is not expected to impact Novozymes' financial results for 2016. "Over the past nine years, our work in albumin has resulted in a series of new discoveries and technologies, which have led to agreements with major pharmaceutical and biotech companies," says Mr Thomas VidebÃ¦k, Executive Vice President for Business Development at Novozymes. "The business is in good shape with great prospects to make a real difference for patients all over the world. We believe it is now ready to be developed further outside Novozymes, where it will have the best possible growth conditions." Albumedix will continue to develop its market leading position within recombinant albumin-based products and technologies for advanced drug and vaccine formulation, extended drug half-life, and improved drug delivery, said Novozymes' press release. It helps biopharmaceutical companies improve patient outcomes with a range of albumin-based products and technologies that facilitate the development of superior biotherapeutics. Albumin is a naturally occurring protein that can be found in human blood. Named Recombumin, Albumedix's recombinant albumins are used in the pharmaceutical industry to stabilize drugs and vaccines. For example, since 2006, Merck has used Albumedix's solutions to produce two vaccines used to treat millions of children worldwide against measles, mumps, rubella and chicken pox. Albumin can also be used to extend the half-life of pharmaceuticals to prolong the drugs' effect and Albumedix offers a first and second generation version of this drug delivery technology under the name Veltis. In 2014, Veltis got its commercial breakthrough when GlaxoSmithKline launched a diabetes drug that utilizes the technology, allowing patients to dose weekly instead of daily. Today, Albumedix has a growing pipeline of partner-driven drug candidates evaluating Veltis. In addition to providing albumin-based solutions to the pharmaceutical industry, Albumedix will initiate the exploration of early stage clinical drug development based on its Veltis technology and relevant drug candidates. ]]> <![CDATA[Glenmark receives 2 ANDA approvals from the FDA ]]> https://biospectrumindia.com/news/95/7799/glenmark-receives-2-anda-approvals-from-the-fda-.html https://biospectrumindia.com/news/95/7799/glenmark-receives-2-anda-approvals-from-the-fda-.html Thu, 21 Jan 2016 11:20:37 +0530 Glenmark Pharmaceuticals USA (Glenmark) has been granted final approval by the United States Food and Drug Administration (US FDA) for Potassium Chloride Extended-Release Capsules USP, 10 mEq. The drug is therapeutic equivalent to the reference listed drug product, Potassium Chloride Extended-Release Capsules USP, 10 mEq, of Actavis Laboratories. According to IMS Health sales data for the 12 month period ending November 2015, the Potassium Chloride Extended-Release Capsules, 10 mEq Market achieved annual sales of approximately $74.1 million. Glenmark has also been granted final approval by US FDA for Norethindrone Acetate and Ethinyl Estradiol Tablets USP, 1 mg/0.02 mg, the generic version of Loestrin 21 1/20 Tablets of Warner Chilcott Company. According to IMS Health sales data for the 12 month period ending November 2015, the Loestrin 21 1/20 Tablets market1 achieved annual sales of approximately $56.8 million. ]]> <![CDATA[ Samsung, Biogen get first EU approval for an Enbrel biosimilar ]]> https://biospectrumindia.com/news/95/7872/-samsung-biogen-get-first-eu-approval-for-an-enbrel-biosimilar-.html https://biospectrumindia.com/news/95/7872/-samsung-biogen-get-first-eu-approval-for-an-enbrel-biosimilar-.html Wed, 20 Jan 2016 11:05:28 +0530 The joint venture between Biogen and Samsung BioLogics, Samsung Bioepis, has been granted European Commission (EC) approval for BENEPALI , an etanercept biosimilar referencing Enbrel. BENEPALI has been granted marketing authorization in the European Union (EU) for the treatment of adults with moderate to severe rheumatoid arthritis (RA), psoriatic arthritis, non-radiographic axial spondyloarthritis and plaque psoriasis. Biogen intends to make BENEPALI available for patients in the coming weeks. BENEPALI is the first etanercept biosimilar referencing Enbrel to be approved in the EU, making it the first subcutaneous anti-TNF biosimilar available there. Anti-TNF's are said to be the largest component of the EU biologics market, accounting for approximately $10 billion of all biologics sold there. "The approval of BENEPALI is a significant step forward for patients and physicians, and an important milestone for Biogen as we bring to market the first product from our biosimilar pipeline," said Dr Alpna Seth, senior vice president and global head of the biosimilars business unit at Biogen. "As a biotechnology pioneer, Biogen is proud to translate our heritage and expertise in biologics to biosimilars. BENEPALI, as the first etanercept biosimilar referencing Enbrel approved in the EU, can help expand access to treatment options for people affected by chronic inflammatory conditions." The EC approval was based on a robust preclinical and clinical data package submitted to the European Medicines Agency by Samsung Bioepis. The data in the preclinical submission leveraged sophisticated molecular analytics, technical development and manufacturing expertise. Confirmatory data from well-controlled, head-to-head Phase 1 and Phase 3 clinical trials compared BENEPALI to its reference product Enbrel. The 52-week, double-blind, Phase 3 study randomized 596 patients with moderate to severe RA despite methotrexate therapy, across more than 70 sites in 10 countries to receive BENEPALI or Enbrel in a 1:1 ratio. Analysis of the primary endpoint showed that BENEPALI had equivalent efficacy to Enbrel, as shown by an ACR20 response at week 24 of 78.1 percent in the BENEPALI arm versus 80.3 percent in the Enbrel arm. Further analysis at 52 weeks confirmed comparable efficacy as shown by an ACR20 response of 80.8 percent in the BENEPALI arm versus 81.5 percent in the Enbrel arm. The safety profile of BENEPALI was comparable to that of Enbrel throughout the study. ]]> <![CDATA[Carestream earns 61 US patents in 2015]]> https://biospectrumindia.com/news/95/7747/carestream-earns-61-us-patents-in-2015.html https://biospectrumindia.com/news/95/7747/carestream-earns-61-us-patents-in-2015.html Wed, 20 Jan 2016 11:04:19 +0530 Carestream Health was awarded 61 new patents from the US Patent and Trademark Office in 2015 for innovations in radiography, cone beam CT imaging, healthcare IT, dental imaging and other areas. The company also received 64 additional patents in European and Asian countries last year. "These patents demonstrate Carestream's continued success in developing and protecting advanced technologies across our global businesses," said Ms Susan Parulski, chief patent counsel for Carestream. "We are committed to delivering new products and technologies that are reliable, easy to use, and enable our customers to improve the quality and value of their services." New patents earned by the company's scientists and engineers include: â€¢New image capture technologies related to the development of cone beam computed tomography (CT) systems designed for orthopaedic extremity imaging; â€¢Enhancements to Carestream's proven portfolio of healthcare IT systems that manage, store and share patient data and medical imaging exams; â€¢Continued technology advances in Carestream's growing portfolio of radiology systems that can enhance medical image quality for a wide range of healthcare providers;â€¢New technology and features for dental imaging, dental image processing and software and dental restoration systems; â€¢Continued developments in Carestream imagers and media that provide affordable printing of digital X-ray exams onto medical film and paper; andâ€¢New product features for Carestream Advanced Materials in the area of transparent conductive films for use in flexible touch panel displays for such products as digital wrist devices, smart phones, digital tablets, laptops and electronic displays. The company's product portfolio includes digital imaging systems for general radiology and specialty areas such as women's health, orthopaedics and pediatrics; digital imagers that output medical images to film and paper; and the latest healthcare IT solutions and cloud-based services for hospitals, clinics and physician practices. Carestream's Dental division develops and markets film and digital imaging solutions, anesthetics and practice management software. Carestream Advanced Materials is a high-quality developer of transparent conductive films based on silver nanowire technology, with research and development facilities and distribution centers throughout Asia, Europe and the Americas. In 2014, Carestream was awarded 66 patents from the US Patent and Trademark Office as well as 34 patents in countries outside of the United States. ]]> <![CDATA[Shire's acquisition of Baxalta headlines strong start to healthcare M&A in 2016]]> https://biospectrumindia.com/features/95/7507/shires-acquisition-of-baxalta-headlines-strong-start-to-healthcare-ma-in-2016.html https://biospectrumindia.com/features/95/7507/shires-acquisition-of-baxalta-headlines-strong-start-to-healthcare-ma-in-2016.html Tue, 19 Jan 2016 14:32:28 +0530 With Shire's acquisition of Baxalta International expected to generate sales of $20 billion by 2020, the deal marks a strong start to healthcare Mergers and Acquisitions (M&A) for 2016, following on from a record-breaking year in which global transactions totaled $680 billion in 2015, according to research and consulting firm GlobalData. Shire agreed to purchase US-based Baxalta for $32 billion after six months of hot pursuit. Shire reported that it has offered to pay $18 in cash and 0.1482 of its American depositary receipts for each Baxalta share, representing a total value of $45.57 per share and a 37.5% premium above Baxalta's closing price on August 3, 2015. Mr Gianfranco Zeppetelli, GlobalData's Deals Analyst, says Shire has consolidated its position as a leading player in the treatment of rare diseases. He explains: "Baxalta develops biotech treatments for rare blood conditions, cancers and immune system disorders and would provide Shire with a strong portfolio of hemophilia treatments, which accounted for 22% of the total global sales in 2014. "Additionally, the acquisition further reduces Shire's dependence on its flagship treatment and primary sales generator Vyvanse." Shire has been bulking up following AbbVie Inc.'s abandoned $52 billion buyout of the company last year and the Baxalta deal is its latest focus on companies with therapies for rare diseases. Mr Zeppetelli continues: "Shire has already moved aggressively into the rare disease treatment market, which accounts for about 40% of group sales, and the inclusion of Baxalta's portfolio would double the size of that business. "In addition to its strength in the rare blood disorder hemophilia, Baxalta has presence in immunology and cancer, and will advance Shire's strategy of building out a broad platform within the rare diseases space. "Baxalta will also benefit from a lower tax rate, perhaps as low as 16% by 2017, as Shire is domiciled in Dublin despite keeping many operations elsewhere," the analyst concludes. ]]> <![CDATA[GM Mustard: Repeating Mistakes]]> https://biospectrumindia.com/views/95/7501/gm-mustard-repeating-mistakes.html https://biospectrumindia.com/views/95/7501/gm-mustard-repeating-mistakes.html Tue, 19 Jan 2016 12:56:26 +0530 An alliance of farmers organizations has recently asked the central government not to proceed any further with field trials of GM mustard. They go further and are asking for a stop to the commercialization of GM mustard. The farmer alliance has in addition demanded that the Government of Punjab recommend to the Centre that all trials of GM mustard be halted. Punjab is an important mustard growing state and its farmers do not want GM mustard. So why is the government pushing for its release, moving ahead with its field trials? If the consumers of this technology have reservations and reject the genetically modified mustard, in whose interest is the government pushing it? Increasingly, GM crops are looking less and less like products that farmers want and more and more like something that someone else wants to force them to have. One thing is clear to anyone who knows the agriculture sector, farmers are not stupid. They know what works for them and what doesn't. They are willing to experiment, accepting and adopting what is suited to their farming and rejecting what doesn't make economic sense. Countering the push for GM crops based on the argument that it is high yielding, farmers in Punjab are pointing out that yield and productivity are not the issue, faulty government policies are the problem. They say that if proper support to crop cultivation and remunerative pricing are enforced as according to the legal framework in place, they should be, then new varieties of mustard are not required. Safety issues can't be ignoredThe commercialization of any GM food crop will of necessity have to demonstrate that it is safe for the environment and not harmful to human and animal health. This will be best achieved by sharing the results of safety testing with the public. But this is exactly what the developers of GM crops refuse to do. Requests for information on biosafety data are turned down citing that such information is 'confidential business information'. This is utterly ridiculous. Information about the nature of the gene construct may be classified and the innovation may constitute 'confidential business information'. But under no circumstances can any information which could have a bearing on public health, be withheld from the public and be termed 'confidential'. The refusal of technology providers and technology regulators to be transparent and share information with the public has led to a growing distrust of GM technology. With the passage of time even those not greatly involved with the debate on GM crops are asking why the government/ industry is hiding data if the data are clean and there is nothing to fear? The more the technology providers hide data, the greater the likelihood of the public contesting the adoption of GM technology. Liability has to be fixedThen there is the issue of fixing liability. In its rush to promote GM crops, government agencies have not cared about bringing in a law on liability and redress. The recent Bt cotton failure reveals what can go wrong with GM technology. In the absence of a national law on liability and redress who is going to be held responsible for the crippling losses incurred by the farmers in Punjab and Haryana ? How will liability be fixed for the failure? Under which law will Monsanto, the owner of Bt technology and the Bt genes and their partner seed companies, be held accountable for the damage caused by the failure of the Bt cotton crop? Gene Campaign has pointed out repeatedly that adopting the new transformative technologies which scientists acknowledge have potential dangers, without a strong legal framework within which the technology should be considered for adoption, is dangerous. It is irresponsible and unethical to expose farmers and consumers, to new technologies without ensuring that they are adequately protected incase the technology fails. In other countries this has been done by enacting laws governing liability and redress so that when a technology goes wrong, the technology provider is legally liable to make good the losses and clean up the mess. The StarLink case is a good example of why laws on liability are important for societies wishing to go the GM route. StarLink is a genetically engineered corn hybrid which was cleared in the US as an animal feed but not as human food. In 2000 StarLink corn was detected in processed foods like taco shells. Aventis, the company that owned StarLink had to trace and buy back all the StarLink corn that had contaminated corn stocks in different parts of the US. They also had to cover the cost of cleaning and sanitizing equipment used to process corn from harvesting and cleaning to storage. It is estimated that in 2001, Aventis could have incurred a cost upto $ 1 billion to clean up the StarLink mess. India continues to have an ad hoc approach to GM crops and those who should know better, have allowed a confrontational situation to develop. This is hardly intelligent. It would be advisable to conduct an honest dialogue about the pros and cons of GM technology and its relevance and use under Indian conditions. Author's bio: Dr Suman Sahai, who has had a distinguished scientific career in the field of genetics, is a recipient of the Padma Shri, the Borlaug Award and other numerous honors. She is founder chairperson of the Gene Campaign which is a leading research and advocacy organization, working on issues relating to food, nutrition and livelihoods. ]]> <![CDATA[Why does India need GM Mustard at all?]]> https://biospectrumindia.com/views/95/8216/why-does-india-need-gm-mustard-at-all.html https://biospectrumindia.com/views/95/8216/why-does-india-need-gm-mustard-at-all.html Tue, 19 Jan 2016 12:52:00 +0530 Thirteen years after the Genetic Engineering Approval Committee (GEAC) had 'deferred' commercial approval for genetically-modified (GM) mustard; the genie is once again back. Costing Rs 70-crore of taxpayer's money, which could have helped set up at least 3,000 new schools, the new GM mustard awaiting approval for commercial cultivation this time comes dressed up in public sector attire. The same claims, the same language (almost the same) and the same fears. Earlier it was Pro-Agro Seeds India, a subsidiary of multinational agro-chemical giant Bayer, which claimed its GM variety containing four foreign genes, would raise the productivity of mustard by 20-25 per cent, and improve oil quality. The new GM mustard that has been developed by the Centre for Genetic Manipulation of Crop Plants, University of Delhi, and contains three alien genes - Bar, Barnase and Barstar -- also makes strikingly similar claims. At the same time, for reasons that can be explained, the promoters of the earlier Pro-Agro GM mustard as well as Delhi University's new GM mustard deny the expression of herbicide resistance, although both use a gene known for it. Pro-GM lobbies distorting facts The country is importing Rs 60,000-crore worth of edible oils every year and therefore there is an urgent need to increase the production of mustard, which in turn means producing more edible oils, goes the refrain. In several panel discussions and public debates on this subject in which I have participated, I have heard Dr Deepak Pental, a former Vice-Chancellor of Delhi University and the lead developer of the new GM mustard, repeatedly assert on the need to cut down on the foreign exchange outgo and also how much would be the resulting saving for a developing country like India. This is exactly what the promoters of the GM mustard developed by Pro-Agro used to claim some 13 years back. Edible oil imports at that time were also around 50 per cent of the domestic requirement, costing the state exchequer Rs 12,000-crore. To any educated person, the argument on the need to reduce the huge import bill on edible oils sounds very appealing. But very cleverly, the GM lobby has used this argument to give an impression as if it is because of the shortfall in mustard production. In reality, it is not so. Let me explain. Former Prime Minister Rajiv Gandhi was piqued over India's rising imports. He was desperate to cut down on what the macro-economists call as the Current Account Deficit. Fuel, fertilizer and edible oils topped the import chart. The annual import bill for edible oils then hovered between Rs 1500 and Rs 3000-crores. Knowing that edible oil imports could be stopped since India had the ability to raise domestic oilseeds production and also undertake processing, he launched a Technology Mission in Oilseeds in 1985. In less than ten years, between 1986 and 1993, doubling of oilseeds production was remarkable indeed, and was later dubbed as Yellow Revolution. From 11 million tonnes in 1986-87, oilseeds production jumped to 22 million tonnes in 1993-94. From a net importer, India became almost self-sufficient in edible oils. With 97 per cent self-sufficiency, India's imports were reduced to only 3 per cent of the requirement. The downslide began a few years later when India deliberately began to lower the import duties allowing cheaper and heavily subsidized edible oil to flow in. The more the edible oil imports, the more the domestic processing industry pulled down the shutters. Flawed Import-Export policy no excuse In 2002-03, when Pro-Agro was trying to market its GM mustard, the imports had touched Rs 12,000-crore at the then prevailing prices. Thirteen years later, when Dr Pental is trying to push the new GM mustard - DMH 11 -- the annual import bill has soared to Rs 60,000-crore. But the rising import bill, as is evident, is not because of any shortfall in domestic production, but resulting from a flawed import-export policy that had brought the import tariffs to almost zero. What is therefore needed is to raise the import tariffs to about 70 per cent or higher (WTO allows India a maximum of 300 per cent import tariffs on edible oils) and then provide a high price and an assured market, farmers would do the rest. At the same time, the claim that GM mustard increases productivity by 20-25 per cent is simply absurd, and if I may say so is motivated. First of all, there is no known gene (or a cluster of genes) that can increase productivity. Secondly, any GM variety is known to be as good as the hybrid in which the alien gene is inserted. Even if a gene simplifies the process of hybridization it does not mean it raises crop productivity. To compare the yield of GM mustard (which essentially means hybrid mustard) with traditional varieties therefore is only unfair. On the related issues of gene flow, contamination and the growth of super weeds, the response so far has been unscientific. In the past 13 years, I have not heard of any complaint about the quality of mustard oil that is available. Mustard has traditionally been used for food (its leaves cooked as sarson ka saag) and should not be viewed only as edible oil. I sometimes use mustard oil for taking care of my ear and nose ailments, for regular body massage, and it is also used in several traditional medicine formulations. It is therefore crucial that the concerns raised by the ministry of environment and forests at the time of imposing a moratorium on Bt brinjal in 2010, the Parliamentary Standing Committee report on GM Foods, as well as the recommendations of the Supreme Court Technical Committee are followed in letter and spirit. The common problem that consumers encounter with mustard oil is its rampant adulteration with cheaper oils. Nowadays I find that even the adulterated mustard oil (mostly with cheaper cottonseed oil or palm oil) that is being openly sold contains a sprinkling of red chilly solution so as to satisfy the taste and smell at the time of cooking. ABLE would do a remarkable public service if it were to launch a consumer campaign demanding the Food Safety Standards Authority of India (FSSAI) to ensure availability of genuine and pure mustard oil. I still can't understand why the Genetic Engineering Appraisal Committee (as it is called now) wants to sweep under the carpet the conclusions arrived in the excellent 19-page report the then Minister for Environment Jairam Ramesh had submitted at the time of announcing a moratorium. Is the GM industry so powerful that the GEAC is willing to scuttle a scientific debate spearheaded by a former minister and is even willing to ignore the resulting health and environmental concerns for no apparent benefit resulting from commercializing GM mustard? Author's Bio: Devinder Sharma is well-known for his views on food and trade policy. Trained as an agricultural scientist, Mr Sharma after serving as the Development Editor of the Indian Express, quit active journalism to research on policy issues. He has been vocal on issues concerning sustainable agriculture, biodiversity and intellectual property rights, environment and development, food security and poverty, biotechnology and hunger, and the implications of the free trade paradigm for developing countries. ]]> <![CDATA[Technological intolerance is hampering GM research]]> https://biospectrumindia.com/views/95/6618/technological-intolerance-is-hampering-gm-research.html https://biospectrumindia.com/views/95/6618/technological-intolerance-is-hampering-gm-research.html Tue, 19 Jan 2016 12:46:00 +0530 The activists opposed to GM technology burned the GM mustard crop in the second year of the first stage before the researchers could collect the scientific data. In the past, duly approved experimental field crops of Bt-cotton were also burned. Field trials are an integral part of biosafety assessment and performance evaluation and are, therefore, essential. Every technology, be it traditional or modern, has its own place and no single technology can solve all the problems. Wisdom lies in integrating them. Technological intolerance should be avoided and there is vast scope for socialism in science too for the progress of agriculture. The opposition to GM mustard now, and to Bt-cotton, Bt-corn, Bt-brinjal, Golden rice, etc. in the past, is not based on science. Most of the people who are organizing the protests, launching signature campaigns and spreading canards about GM crops, are not scientists. Nor do they seem to attach any importance to scientific facts. The truth is that GM mustard, DMH -11 (Dhara Mustard Hybrid -11), has gone through all the prescribed biosafety tests for over 15 years and has been established by GEAC to be safe for humans, animals and the environment. It has the potential to increase the yield of hybrids between 20 to 30% without adding any extra cost to its cultivation. It can thus help the farmers to earn more money while enabling India to produce sufficient quantity of an important edible oil that is now being imported, along with other cooking oils, at an annual cost of over Rs.56,572 crores (as of 2014). Safe and beneficial:As far as safety is concerned, the oil and feed from the GM rapeseed have been consumed extensively since 1996 in Canada and several other countries without any scientifically proven ill effects. Then, is the opposition justified? Previously, the opponents in India, with the support of their counterparts in other countries, opposed Bt-cotton even before it was tested and they continue to do so even after its remarkable success of over 13 years following its commercialization in March 2002. Currently, Bt-cotton occupies over 11 million hectares comprising 95% of the total cotton acreage in India. Adopted by more than 7 million farmers, it has significantly contributed to the social and economic benefits of the farmers with no adverse impact on environment, and turned India from a net importer to an exporter of cotton. However, the activists, instead of gracefully accepting this outstanding success, continue to indulge in fault-finding and even try to associate it with farmers' suicides! They vehemently opposed Bt-brinjal also in India. The Govt. of Bangladesh brushed aside the protestors and, based on scientific recommendations, took a bold decision and approved its commercialization in 2014 which is significantly benefitting its farmers. Presently, various GM crops are cultivated in about 30 countries and they have significantly contributed to enhanced productivity and farmers' welfare. Against this background, it is difficult to understand why there is such an aggressive opposition! The various accusations orchestrated repeatedly by the opponents are baffling. They are speculative and their concerns are unauthenticated! In fact, no other crops or food products have been subjected to as stringent a testing and evaluation as are GM crops prior to commercialization. Globally, over two thousand studies dealing with the safety of GMOs have been published in reputed scientific journals. Almost every major scientific body and regulatory agency in the world, that include countries like the USA, Australia, New Zealand, France, United Kingdom, Belgium, Germany, India, etc., have reviewed such research data and strongly vouched that the food and feed derived from GM crops are as safe as those produced conventionally. What more do the opponents want? GMOs are a product of scientific research. Leave science to scientists. Please do not take science to streets. Bt-brinjal was enough! Signature campaigns do not reflect the merit of research, especially when the product is yet to be born and reach the end users. Strange attitude: GM mustard has been developed by a public institution - Delhi University with support from DBT. Earlier, the adversaries opposed GM technology because the products were developed by private sector. Now, they are opposing even the public sector. Their claim is that it is meant to pave the way for entry of private sector! It is difficult to understand their stance. For example, on one hand, if the government discloses the GM crop trial sites, they go there and vandalize the experimental crop or even burn them as they did with Bt-cotton and GM mustard. On the other hand, if the sites are not disclosed, they allege that the government is hand-in-glove with the product developers and, therefore, is keeping everything under wraps! Similarly, if the scientists do not openly express their opinion on GM crops, they conclude that they are doubtful or not confident about the technology, hence the silence. On the other hand, if they speak in favour of the technology, they brand them as being bribed and insult them. On being sensitive to their integrity being questioned in public, most of the scientists and also farmers and other supporters of GM technology, prefer to keep quiet. This offers an advantage to the opponents. As they are very aggressive and vocal, only their voice and views are heard, thereby confusing the gullible public. It is a typical case of Silent Majority vs Loud Minority! Shun intolerance and be secular: If the opponents believe in any specific technology, they are most welcome to practice and promote it. There is no need for them to denounce other technologies. To declare a wholesome war against GM technology with slogans like 'GM free India' betrays their lack of understanding of alternative technologies. Such technological intolerance or technological prejudice and needless interference should be avoided. It has already hampered the progress of research and affected the product developers (both public and private), scientists working in biotech sectors, students of biotechnology and, moreover, the farmers who need effective technologies to face the emerging challenges. Merely opposing a technology without any scientifically authenticated reasons or offering tangible alternatives does not contribute to progress. Scientists are as, if not more, concerned about the society and environment as the so-called environmentalists. They try to develop technologies to benefit the community. The opponents may criticize, but should not try to kill a technology! It is indeed possible that there are individual scientists or group of scientists or research organizations that believe in traditional ways of cultivation and are averse to modern technologies. However, it is noteworthy that while the approaches may vary, the noble objective of all technologies, be it traditional or modern, is to achieve adequate production to feed the teeming millions. Over the years, one has realized that every single technology is important in enhancing crop production and protection. There is thus a need to harness all the technologies. It is like practicing secularism in science! This is possible if all those with divergent views talk to each other, listen to each other and understand each other in the best interest of agriculture and feeding the society at large. Here is an opportunity for the opponents of GM technology to review their stand and join hands with other scientists to promote agriculture. Technological intolerance has no place in science. Rather, a judicious integration of available technologies, depending upon their suitability to a particular situation, should be explored which augurs well for the future. Together we can take agriculture to the next level. Author's Bio: Dr T M Manjunath is an agricultural entomologist with over four decades of research and executive experience, both in public and private sectors. He worked extensively on the bio-ecology and control of a wide variety of insect pests, including those of cotton, rice, sugarcane, maize, coconut, vegetable and other crops. His two books "Q&A on Bt-Cotton in India" (2007, 2011) and "GM Crops: Perception vs Reality" (2015) are aimed at clarifying doubts related to GM crops. He is an author of over 100 research and review papers and six books, and has delivered innumerable lectures, including many keynote addresses, in these areas. ]]> <![CDATA[GM Mustard can enable domestic reliance in edible oils ]]> https://biospectrumindia.com/views/95/7466/gm-mustard-can-enable-domestic-reliance-in-edible-oils-.html https://biospectrumindia.com/views/95/7466/gm-mustard-can-enable-domestic-reliance-in-edible-oils-.html Tue, 19 Jan 2016 12:38:55 +0530 It is important to note that anti-GMO activists who are opposing GM mustard, a hybrid variant of mustard are up against a team led by Dr. Deepak Pental, noted geneticist and former Delhi University vice-chancellor. Dr. Pental's project on-going for over 16 years has been funded by the university and the National Dairy Development Board (NDDB), which, at one time, was entrusted with ensuring self-sufficiency in cooking oil through the Technology Mission on Oilseeds and Operation Dhara. This is an entirely indigenous effort. Is GM Mustard important? Is it needed? And who will it benefit? Let's take a look at the big picture first. In 2013-14, for which data is available, India imported 14 million tonnes of cooking oil for a staggering US$10 billion or Rs 66,000 crore. Edible oil is by-far the biggest item of food import and also makes India the largest importer of edible oils in the world. Edible oil is also the third largest import after crude oil and gold. It is remarkable to the extent to which imports have risen - from 4.4 million tonnes in 2003-04 to 14 million tonnes in the current year. But until 2007-08, India's edible oil production exceeded its imports. It is after that the situation completely reversed. It is also important to note that this is the cost that India pays when global edible oil prices are down by around 20 - 25%. If global prices were to recover, the prices would be significantly higher. Unfortunately as our import dependency goes up (from 30 percent to nearly 70 percent in the last few years) there is no silver lining in sight (unlike in global crude oil prices where prices dropped and continue to remain low). Massive imports have driven down Indian soybean prices by 20 percent in four months, discouraging farmers from expanding oilseed area. But despite this, local soyoil is still 50 percent costlier than imported palm oil. Despite the recent increase in import duty by the government, oilseed cultivation is not profitable for the Indian farmer. India needs to therefore increase the productivity of all oilseeds in every possible manner. The twin-pronged advantage is that the import bill goes down and the Indian farmer benefits. GM mustard is an initiative towards this. Dr. Pental's version of the hybrid seed will yield 20-30 per cent more crop. Increased yields will reduce the price of mustard oil and relieve the oil shortage. Like with Bt Cotton, where India went from a net importer to one of the world's largest exporters in a period of around 10 years, being self-reliant could help India earn foreign exchange as well and pave the way for replication with other oilseeds as well. Safety & human consumptionGM Canola, a sister crop of mustard, has been used extensively for hybrid seed production in rapeseed in Canada and Australia. In 2014 alone, Canada exported 9.6 million tonnes of seed, 2.3 million tonnes of oil and 3.4 tonnes of seed meal to all parts of the world. Japan, a country that does not grow any GM crops, was the biggest importer. Canadian rapeseed oil, high in quality, is also being sold in the Indian market as a premium health oil under the brand name Canola. It is ironical that we are fine consuming oil from Canola and Soybean, which is derived from GM crops and have several food items which are imported and mostly likely contain ingredients, which in turn are derived from GM crops but a technology developed in India is being opposed. The first generation hybrid developed using GM methodology for pollination control yields 20-30 per cent more than the leading non-GM varieties currently in the field without any additional inputs of water or fertiliser. Better hybrids will follow as has happened with other crops around the world. As the research on mustard has been funded entirely by the department of biotechnology and National Dairy Development Board (NDDB), hybrid seed should reach the farmers at a very reasonable prices. Benefitting the farmerWhile the GEAC takes a decision on GM Mustard, anti GM activists are leaving no stone unturned to create a strong fear psychosis in the minds of farmers and consumers alike. For the average middle class mustard oil consumer who does not understand GM technology, propagating untruths that have no scientific or rationale basis will create misconceptions that are easy to exploit by stakeholders with a vested interest against GM Mustard and those not inclined to making India self-reliant in edible oils. However, given that this research has been spearheaded by an entirely indigenous team and funded by publicly funded organisations, there is no 'foreign hand' to blame this time. So, the government and researchers are being blamed for clandestinely and wilfully bypassing safety rules and/or withholding information from the public. This is an allegation that is unfair and untrue. No government or organisation (private or international) anywhere in the world bypasses safety concerns and wilfully allows the perpetuation of a crop that will be unsafe or unfit for human consumption. Why would we believe that India is any different? The opposition, however, will keep on benefiting the farmers of Canada and USA, help their economies but will deprive our farmers to have a chance to look at the technology and their decision whether to grow GM mustard or not and continue to strain our economy with increasing import bills. Plant breeding, conventional and GM, will be foundational in meeting the challenge of bringing about low-input, high-output agriculture in the 21st century. Use of GM technology in developing productive hybrids in mustard is a step in that direction. No one, least of all Dr. Pental, the inventor of GM Mustard, is saying that this technology should be put into the farmer's field without relevant studies. In fact we all urge the government to review the data critically. But give science a chance. Author Bio: Dr Shivendra Bajaj has Ph.D. in Genetics from University of Delhi, South Campus. With over 20 years of experience in the field of biotechnology and research, Shivendra has joined ABLE- AG from DuPont Pioneer National Biotech Regulatory Cooperation Lead and China and Asia Pacific Regulatory Science and Operations Lead. He worked at DuPont Pioneer for over seven years and prior to joining there, he was a senior scientist with ViaLactia Biosciences in Auckland New Zealand. Shivendra has also worked with Monsanto India as a Regulatory Manager in Biotechnology during the initial years of his career. ]]> <![CDATA['GM crop is essential for India']]> https://biospectrumindia.com/interviews/95/7112/gm-crop-is-essential-for-india.html https://biospectrumindia.com/interviews/95/7112/gm-crop-is-essential-for-india.html Tue, 19 Jan 2016 12:32:55 +0530 What is the current status of GM crop trials? On receiving the application for field trials we strictly scrutinize safety of trials because safety matters a lot. When we are trying something new, which was not in existence, that must go through the complete safety regime. Therefore after due diligence and successful lab tests applications are considered and allowed for field trials. After successful commercialization of Bt cotton in India why are other crops not allowed for commercialization as farmers are already growing them in other countries? About 80 percent farmers have adopted Bt cotton in the country and it is giving results. Finally it is the farmers who are the deciding factors. On one hand the Ministry of Science and Technology, Agriculture Ministry, and other departments have been supporting biotechnology, fortification of foods. On other side Ministry of Environment and Forest is not allowing field trials of GM crops and not allowing release of the crops. What is the rationale behind such dual action from the government? We believe that science cannot be stopped. Science must evolve, science must progress and we must not stop experimenting. So our policy is that we continue experimenting with proper safety regime. Research has to go on and can't be discontinued. We have only 2.5 percent of the world's land mass. We have only one half of the world's average productivity. We need to increase our productivity as we can't increase our land size. We have to feed to 17 percent of human as well as 17 percent of cattle population of world with 2.5 percent of land. So we have to more efficient, more productive. Therefore GM crop or any other scientific development, which will increase our productivity, is essential for India. What are the issues involved in GM crops controversy? Since India is a Federal nation there is freedom for state governments. States can give permission for tests or states cannot allow field trials. At the central level we have given approval/cleared for conducting field trials. What is happening is that no state governments are allowing the field trials. Only three or four trials, which were earlier allowed on agriculture university land, are on. So, practically on ground there are no field trials. Organizations from both public and private sectors are involved in GM crop research and development including filed trails. Why is the government taking step backwards while allowing them from transfer technology to the private sector? Currently we have allowed local organizations, who are doing research and want to do trials to conduct field trials. These organizations will not get opportunities elsewhere in the world so they must be provided opportunities. GEAC has allowed import of GM soybean oil but still the government is not allowing release of GM crops for cultivation? The world is already using GM soybean oil. There are many products which otherwise also enter our country, because these products are being used by other nations by allowing to be planted, to be grown, to be commercialized and to be exported. The GEAC has allowed import of Soybean oil based on result of safety study and results of the trials. As of now we have received only one application for commercialization of mustard after successfully conducting safety tests and lab trials. At the same time we have to decide about our priorities also. Our priority has to be and is oilseeds and pulses, because that is what will be in short supply. Only few countries have given approval for commercial cultivation of GM crops. Soybean is oilseed but soybean trial has not been fructified till and there is no application for commercialisation of GM soybean. ]]> <![CDATA[Moving towards GM Oils]]> https://biospectrumindia.com/features/95/4110/moving-towards-gm-oils.html https://biospectrumindia.com/features/95/4110/moving-towards-gm-oils.html Tue, 19 Jan 2016 12:25:14 +0530 By Narayana Kulkarni The Genetic Engineering Appraisal Committee (GEAC), an apex body in India authorized to approve the use of genetically modified (GM) crops or organisms in the country, at its meeting in July 2014, had approved the import of refined soybean oil derived from transgenic soybean by three companies - Bayer Bio-Sciences, BASF India, and Monsanto Holdings. The GEAC had given a clean chit after the samples of refined soybean oil were tested at Central Food Technological Research Institute (CFTRI) and approved. However, so far no import of transgenic refined soybean oil has taken place. The three global agricultural companies which received the approval are offering agricultural solutions to farmers all around the world. Since 1996, these companies have received approvals for commercial cultivation of soybean in about six nations. But the transgenic crop is available for food, feed and processing use in over 20 nations excluding European Union and Russian Federation. It is a mandate that all traits need to be cleared/de-regulated for trade, worldwide. Hence these companies have submitted biosafety information with GEAC about the events and got approval from the regulatory agency. This will help the trading companies or processing units who are looking for import of transgenic soybean oil to get green signals for their applications without delay. According to Soybean Processors Association of India, popularly known as SOPA, the only national level body representing the soybean processors, farmers, exporters and brokers in India working towards the aim to strengthen soybeans as a viable crop, there are 112 processing units in India processing soybean with modern processing technology. "As a responsible technology developer and owner, Monsanto submitted event-based scientific data as per regulatory guidelines, to facilitate soybean oil commerce and industry. We would like to clarify that Monsanto does not engage in any manufacture of soybean oil nor does it manufacture or trade for the same in India. With soybean oil forming a sizable share of India's edible oil imports, we believe this decision by the GEAC will help in partially meeting India's edible oil demand," said spokesperson from Monsanto India. Expressing similar views BASF spokesperson said, "It is a mandate that all traits need to be cleared/ de-regulated for trade, worldwide. That's why we applied for the approval from GEAC. However, BASF is not a producer or exporter of transgenic soybean oil. Since August 2015, BASF in partnership with the Brazilian Company for Agricultural Research (EMBRAPA), is commercialising the Cultivance Production System, which consists of herbicide tolerant soybeans varieties. At the moment, the commercialisation of the Cultivance Production System is only available to Brazilian farmers." Sharing his views on the need for soy consumption Dr Suresh Itapu, CEO, NutriTech Consulting Services, said, "Soybean has been considered as nature's nutritional gift packed with lot of health benefits. It is one of the very few plant food sources that provide a high quality protein with minimum saturated fat. Soybean helps people feel better and live longer with an enhanced quality of life. Soy protein is the only commonly consumed plant protein that is 'complete', meaning it contains all of the essential amino acids in sufficient quantities to meet human requirements. In India protein and energy malnutrition is rampant and we are also a predominantly vegetarian country. Therefore, it makes sense for us to use soybeans regularly in our diet." "Ordinarily, the nutrition composition should not change with GM or Non-GM. However, other aspects that affect health cannot be put forth in the absence of scientific study. In the absence of such investigation, indication on either way may not be appropriate," said Dr SD Kulkarni, Centre of Excellence on Soybean Processing and Utilization, Central Institute of Agricultural Engineering (CIAE), Bhopal, while sharing his views on nutritional aspects of transgenic soybean oil.The five events that received the GEAC's approval include two each from Bayer Bio-Sciences and Monsanto and one event from BASF India. The GEAC's approval for these events is for two commercial traits (Singular) Herbicide Tolerance (Liberty Link soybean - A2704-12 and A5547-127, Cultivance - CV127, Genuity Roundup Ready 2 Yield- MON89788) and (Stacked) Herbicide Tolerance + Insect Resistance (Intacta Roundup Ready 2 Pro - MON87701 x MON89788). The event A2704-12 traded under the name Liberty Link soybean from Bayer CropScience has got the regulatory approval from AVA - Approved GMOs Singapore, European Food Safety Authority, Food Standards Australia New Zealand, Health Canada, Japan Biosafety Clearing House, US Department of Agriculture - APHIS and US Food and Drug Administration for food, feed and domestic cultivation. This event received the first approval in 1996 for domestic cultivation from the USA authority and got the approval for direct feed and food use and processing in 1998. Later many developed countries like Canada and Australia gave approval followed by developing nations like Thailand, Malaysia, and Brazil. Besides, Russian Federation and European Union, this event has received approvals from 21 nations. So far six countries have given approval for commercial cultivation for this event first being the US in 1996, followed by Canada in 1999, Japan in 2006, Brazil in 2010, Argentina in 2011 and Uruguay in 2012. A5547-127 another event traded under the name Liberty Link soybean from Bayer Crop Science received approval from 19 nations including European Union in 2012 and Russian Federation in 2008. The USA authority gave the approval for food, feed and domestic cultivation in 1998. In 2014, India, China and Malaysia gave approval for food and feed use while Singapore gave approval in 2015 for food and processing use. CV127 traded under Cultivance from BASF, the event has been commercially cultivated in six countries since 2009 in Brazil, Canada in 2012, Argentina in 2013 and Paraguay, the US, and Uruguay in 2014. But this event has been approved for food, feed and processing use in 20 countries. European Union gave the approval only this year. Monsanto's Intacta Roundup Ready 2 Pro - MON87701 x MON89788 event is being allowed for cultivation in four nations since 2010 in Brazil, 2012 (Argentina and Uruguay) and Paraguay in 2013. This event is approved in 15 nations for food, feed and processing use for having (Stacked) Herbicide Tolerance + Insect Resistance trait. The GEAC which met under the chairmanship of Hem Pande, Additional Secretary, Ministry of Environment, Forests and Chairman, GEAC has also given the green signal for field trials of genetically modified (GM) rice, cotton, chickpea and brinjal including mustard. Besides allowing the import of transgenic refined soybean oil, the government is considering allowing commercial cultivation of GM mustard crop, called DMH 11 (Dhara Mustard Hybrid 11), and developed by the Centre for Genetic Manipulation of Crop Plants (CGCMP), Delhi University, with support from the Department of Biotechnology(DBT) and the National Dairy Development Board. Mustard is an oilseed, vegetable and fodder crop grown on around 5.5 to 7 million hectares in India. It is mostly grown as a rabi or winter crop in India. While it is sown as a sole crop in some regions, it is also grown as an intercrop in others. Brassica (rapeseed/mustard) has slowly taken over soybean and groundnut as the most important edible oilseed crop in India. While soybean oilseed production was 14.66 million tonnes in 2012-13 and 11.99 million tonnes in 2013-14, in terms of oils, it was only second to rapeseed and mustard (R&M): soybean was 2.35 million tonnes while R&M was 2.49 million tonnes in 2012-13; this further fell to 1.92 million tonnes of soybean in 2013-14, with R&M being 2.47 million tonnes in 2013-14. The average annual growth rate of R&M between 2008-09 and 2013- 14 has been 3 percent in area, 7.3 percent in production and 3.9 percent in yield. Mustard oil is reported to have the lowest amounts of saturated fatty acids and contain adequate amounts of linoleic and linolenic fatty acids. In terms of conversion to oil from seeds, R&M has a 33 per cent conversion rate which is higher than several other oilseeds like soybean, groundnut etc. The conversion to oilseed cake (used for cattle feed as well as soil fertility input) is 67 percent. Reacting to the GEAC's approval, Dr S D Kulkarni said that in the absence of information on actual backGEAC ground it is difficult to be precise on the indication. However, he pointed out that there may not have been alternative sources of edible oil, to transgenic soybean oil, in abundance in the world market to meet the requirement of edible oil of our country. The transgenic soybean oil might be available at appreciably low cost compared to other alternatives of edible oil available for import. India has been an importer of edible oil for long years because of a mismatch between demand and domestic production. In recent years, the supply shortfall has widened rapidly, driven by rising incomes and population pressure. Every increase in income translates to a rise in demand for food products including cooking oil. Consumption-driven demand growth has outstripped domestic supply growth, increasing the country's import dependence to nearly 60%.According to Oil World, a global market research on oilseeds, oils and meals, India has become the world biggest importer of vegetable oils, with an import volume of 14.1 million tonnes in 2014-15. According Solvent Extractors' Association of India, import of vegetable oils during Oil Year 2014-15 (Nov 2014 to Oct 2015) i.e. edible oil and non-edible oil, set a new record level of 14.61 million tonnes compared to 11.82 million tonnes for the same period of the previous year, up by 23.64%. Oil year 2014-15, has set a new record for highest import of palm products as well as soft oils like soybean, sunflower and rapeseed (canola) oils. India has imported highest quantity of soybean, sunflower and rapeseed oils this year due to its attractive price. The main reason for overall increase in import of vegetable oil are; i) Local consumption of edible oil further increased due to increase per capita consumption (4.5%) and population growth (1.76%). Also lower price of vegetable oils boosted the consumption of vegetable oils. ii) Oilseed production reduced due to deficit rain in last two years, resulted in lesser availability of oils in the country. iii) Excess supply of vegetable oils in international market coupled with low price, boosted import. iv) NIL export duty by Indonesia and Malaysia also boosted their export to India.According to GG Patel & Nikhil Research Co, India's edible oil usage may total 21 million tonnes in 201516, with per-capita consumption growing at about 5 percent from 7.4 percent this year. Palm oil shipments may jump to 9.6 million tonnes in 2015-16 from 9.04 million tonnes, while crude soybean oil imports are seen rising 18 percent to 3.55 million tonnes. India's total vegetable oil availability may increase by 2 percent to 6.26 million tons next year, boosted by higher production of rapseed oil this year. Rapeseed production may jump 16 percent to 5.8 million tonnes, while soybean output will be unchanged at 8.5 million tonnes and the peanut harvest may drop 12.7 percent to 3.1 million tonnes. India meets more than half its cooking oil requirements through imports with palm oil shipped from Indonesia and Malaysia and soybean oil from the US, Brazil and Argentina. Sharing his views on Indian oilseeds market at Globoil 2015, Atul Chaturvedi, CEO, Adani Wilmar said, "Oils....in the late nineties when India opened up oil imports under open general license our total consumption used to be only 10.5 million tonnes of this the imported component was only about 4.5 million tonnes. With rising income levels and changing food habits coupled with competitively priced palm oils demand sky rocketed and currently we are consuming almost 19 to 20 million tonnes of oil. Out of this the imports are almost 13.75 million tonnes. In other words local availability has practically shrunk to around 5.5 - 6 million tonnes. About 70 per cent of our requirement is met by imports which are growing at almost 1 million tonnes per annum valued at around $12 billion. Consumption growth is pegged at 5 percent and we would be consuming around 34 million tonnes of oil by 2025. The import requirement of oils would balloon to 25 million tonnes and domestic availability will only be 9 million tonnes at current rate of growth." India has to exploit domestic resources to maximize production to ensure edible oil security for the country. Oil palm is comparatively a new crop in India and is the highest vegetable oil yielding perennial crop. Therefore, there is an urgent need to intensify efforts for area expansion under oil palm to enhance palm oil production in the country. Besides India needs to push the growth of oilseeds production for other crops like soybean, mustard, sunflower and rapeseed. According to the United States Department of Agriculture (USDA), India's soybean output at 11.5 million tonnes in 2015-16 as against 10.5 million tonnes estimated by India's Ministry of Agriculture for 2014-15. "The global food demand will grow by 70 percent or more by 2050, according to Food and Agriculture Organization (FAO), along with a significant need for protein. Maintaining current protein production levels would cause strain on land, water and fossil, fuel resources. Soybeans produce more amount of usable protein per acre of farmland than all other forms of complete proteins. When comparing land impacted by production and end product, soy protein offers, a protein solution that is 17 times more effective. Soy is a perfect solution for the mankind with decreasing natural resources like water and land and increasing protein demand. It is very profitable nutrition and health wise to incorporate soy products in our daily diets as much as possible. Some of the Indian studies have shown that soy protein is more effective in Indian population compared to others," adds Dr Suresh Itapu. Commenting on GM crops, Atul Chaturvedi said "India is a great debating country and debates can last for minimum two decades. The debate on GM has been going on for more than two decades and chances are that finally the government may bite the bullet in next decade. India currently has more than 11 million hectares of land under GM, much more than China. Tragedy is that all this land is under cotton. In future this may get extended to corn and oilseeds as well." Kiran Mazumdar-Shaw, non-executive chairman of Association of Biotechnology Led Enterprises (ABLE), a not-for-profit pan-India forum that represents the Indian Biotechnology Sector said "If Bangladesh farmers are reaping the benefits of GM Mustard (developed by Indian geneticists) and no reports of 'harm' are evident then why should we pay heed to unscientific scaremongering of the tireless and tiresome so called environmentalists? Why should Indian farmers be disadvantaged? However, Dr Dharini Krishnan, director, D V Living Sciences Enterprises and chairperson of the Registered Dietitian Board (RD) of the Indian Dietetic Association (IDA) quoting a French study opined "Mice, who were fed with a diet of Monsanto's genetically modified maize sprayed with Roundup were much more likely to die at an earlier age, in addition to other health problems. Hence I disapprove the need for going for GM crops in India." On the other side echoing the voice of the industry involved in agribiotehcnology, Dr Shivendra Bajaj, Executive Director at The Association of Biotech-Led Enterprises-Agriculture Focus Group (ABLE-AG) said "Our view as an association of organizations conducting research in biotechnology is that we fully support biotech mustard or any technology that could lead increase in agricultural productivity in India. India needs biotechnology especially in oil seed crops and pulses. The success of Bt cotton has demonstrated that with this technology can lead to significant gains to farmers in general and to the country in general." ]]> <![CDATA[Strides wins CCI approval to buy 7 brands of J&J ]]> https://biospectrumindia.com/news/95/7377/strides-wins-cci-approval-to-buy-7-brands-of-jj-.html https://biospectrumindia.com/news/95/7377/strides-wins-cci-approval-to-buy-7-brands-of-jj-.html Tue, 19 Jan 2016 12:10:41 +0530 Strides Shasun has received Competition Commission of India (CCI) approval to acquire seven brands from consumer healthcare firm Johnson and Johnson (J&J). "... approves acquisition of certain brands of Johnson and Johnson by Strides Shasun Limited," CCI tweeted. Last year, Strides has struck a deal to acquire seven brands from J&J. As per the deal, Strides will buy J&J's seven brands in dermatology, anti-emetic and pain management segments. The brands that the company will acquire include Otogesic ear drops, Ethnorub ointment and Stugil tablets. Financial details of the transaction were not disclosed. ]]> <![CDATA[GM Mustard debate heats up ]]> https://biospectrumindia.com/features/95/7783/gm-mustard-debate-heats-up-.html https://biospectrumindia.com/features/95/7783/gm-mustard-debate-heats-up-.html Tue, 19 Jan 2016 12:10:22 +0530 A fresh controversy on the possible approval of genetically modified mustard has been stoked by the recent turn of events. To begin with, there has been an online petition against its approval by Dr Vandana Shiva, the well-known anti-GM Crops activist. That was followed by protests from groups like Swadeshi Jagran Manch. Activists claim that the non-transgenic seeds too provide higher productivity, and that the genetically modified seeds will pose severe health hazards like male sterility and other problems to both people and the environment. They call it losing of seed sovereignty and paving the way for backdoor entry of MNCs that are into GM crops. At the same time, the biotech industry under the banner of Association of Biotech Led Enterprises-Agriculture Group (ABLE-AG) has been vocal on pro-GM Mustard stance. Besides that many farmer groups too have voiced their support. The argument here is that the science can't be stopped and the agriculture has to be empowered through technology to prepare for future. "The protest by some of these ill-informed groups implies that they do not even want a scientific review of the research. All we are saying is that let GEAC make a decision. Protesting against a technology without letting the regulators review the efficacy and safety is not right. In any case, we would like to highlight that genetically modified food has been consumed for over two decades across the world and not even a single case of adverse effect has been reported," says Dr Shivendra Bajaj, executive director, ABLE-AG. Meanwhile, the union government clearly appears to be again walking on a tightrope. The agriculture ministry and science and technology ministry have been voicing their open support but the final decision on environmental clearance lies with the concerned ministry. Decoding the issueThe researcher who has been spearheading the work on GM mustard indigenously is Dr Deepak Pental, geneticist and former vice chancellor, Delhi University. These GM mustard seeds called the Dhara Mustard Hybrid 11 (DMH-11) have been developed by his team in collaboration with various organizations after 19 years of research. Close to Rs 90 crore has been spent on the project which also includes development of some non-transgenic hybrid mustard crops and setting up of a research facility. Of this, about Rs 50 crore came from National Dairy Development Board (NDDB) while the rest came from the department of biotechnology (DBT) and smaller grants. Earlier Genetic Engineering Appraisal Committee (GEAC) had given go ahead to Centre for Genetic Manipulation of Crop Plants (CGCMP) at Delhi University for large-scale BRL (Biosafety Research Level) II trials. As per the statements of Dr Pental which are on record, the transgenic mustard hybrid variety will provide a 30 per cent higher yield than other varieties and the costs for these seeds will be lower. As per him, the safety of GM Mustard had been proven by the continued cultivation, sale and export of Canola oil in Canada since 1995 and in the US since 2002, which is based on similar transgenic technology. As per Dr Pental, "India's poor are mostly consuming palm oil and hydrogenated oils - both not very healthy. A GM-based pollination control mechanism for producing hybrids is being confused with ill-conceived "Terminator technology. Use of a common gene does not transform a pollination control technology into a Terminator technology. Yes, GM mustard uses a gene conferring resistance to herbicide Glufosinate. It is also correct that all herbicides kill plants, especially weeds. But the truth ends there, the rest is mischief." The matter has again got heated due to the allegations that the research team hasn't revealed the data generated from the field trials. The reasons cited to the GEAC by the team are that there are commercial considerations and the same have been accepted by the committee. Meanwhile, after the research team submitted the data to GEAC in May, 2015 which was followed by a dossier in mid-September, there has been no decision by it yet on allowing the commercial cultivation which of course has to be later ratified by the environment ministry. Where does govt stand on this?The state governments under pressure from local groups have expressed their reservations. While Rajasthan withdrew its permission in 2012, during November, 2015, the Punjab government issued directions to the Punjab Agricultural University (PAU) not to conduct further field trials of GM mustard following the concerns expressed by civil society groups. At the same time, the union government has not accepted the moratorium recommendations of the technical committee constituted by the Supreme Court on the basis of the facts that current regulations and protocols followed in biosafety assessment are as per international best practises. It has also accepted the argument by researchers that field trials are an integral part of biosafety assessment and trials are necessary to generate biosafety data. Further, the government's official position has made it clear that any ban on GM crop field trials would stop all research activities in the country which may have long term implications on food security issues. However, there have been no clear decisions. Way forward Finally, the question remains that whether the GM mustard too would meet the same fate as Bt Brinjal. However, before putting any ban again, it is important to note that about 60 percent of our edible oil needs are imported each year at an annual cost of up to $10 billion which is India's third-biggest import item after crude oil and gold. Therefore, the enough clarity on technology through information has to be provided equally to supporters and bashers of the technology for better understanding. Whatever the reasons be, that is not possible when there is no clear date on when the GEAC is meeting and the minutes too are unavailable. Also, this issue has been mostly debated through the media but now the time has come when there is a need for a proper discussion between two warring sides. However, a middle way that is acceptable to both sides could be carved and for that the policymakers will have to play their part well. . The government too cannot afford to avoid the issue any longer as its various ministers too have in recent past reaffirmed confidence in the technology. Decisiveness is what is required here. ]]> <![CDATA[AIMS Kochi affiliated as nodal centre for UNESCO bioethics for SAARC countries]]> https://biospectrumindia.com/news/95/7543/aims-kochi-affiliated-as-nodal-centre-for-unesco-bioethics-for-saarc-countries.html https://biospectrumindia.com/news/95/7543/aims-kochi-affiliated-as-nodal-centre-for-unesco-bioethics-for-saarc-countries.html Tue, 19 Jan 2016 10:28:43 +0530 AIMS at Kochi has been appointed as the Nodal Centre for UNESCO Bioethics for SAARC countries. Dr N Dinesh from AIMS has taken charge as the Head, Kerala State, for the UNESCO Bioethics Network. The event to mark the occasion was attended by Justice JB Joshy, Chairperson, Kerala Human Rights Commission; Dr Prem Nair, Medical Director, Amrita Institute of Medical Sciences; Dr P Venkat Rangan, Vice Chancellor, Amrita University; Dr Russell D'Souza, Head, Asia Pacific Division of Chair of UNESCO Bioethics; Prof Dr OP Kalara, Vice Chancellor, Pandit BD Sharma University of Health Sciences, Haryana; and Prof Dr Arun Jamkar, President, Association of Indian Health Science Universities, along with Dr Mary Mathew, Head, National Training UNESCO Bioethics in Haifa and Dr A Marthanda Pillai, Coordinator, National UNESCO IMA Bioethics. The UNESCO Bioethics Network in collaboration with the Amrita Institute of Medical Sciences will study and develop curriculum for teaching, training and research in the field of bioethics (the field of ethical practice in medical and biological research), in order to address the lack of a composite bioethics structure in the SAARC countries. The mandate is to develop an up-to-date syllabus for medical ethics education based on the well-accepted core curriculum of the UNESCO, which would also satisfy the requirements of medical schools in a region. The network offers opportunities to collaborate in research across countries in answering research questions in ethical issues, including areas that might have cultural and religious variations which could impact the method of teaching of ethics and the practice of ethics in clinical and other areas. It also offers opportunities for research in bioethics and trains senior teachers in bioethics using the UNESCO Ethic Teachers Training Course. The ethics syllabus aims to reduce incidents of ethical misconduct and malpractice by doctors who forgo ethical ways of practicing medicine. It attempts to raise the bar of ethical standards of upcoming medical practitioners and researchers so that they are more compassionate and understanding with patients and patients' families, and treat them with respect, compassion and care. "With over two thousand students currently enrolled in our schools of medicine, dentistry, pharmacy, nursing, and allied health sciences, we can ensure maximum impact with regards to the dissemination of ethical standards of practice and conduct in clinical as well as research areas. This will also help our students achieve worldwide projection", said Dr N Dinesan, the newly appointed Head for the Bioethics network at AIMS. The Indian medical education and health professional training program is the largest in the world with nearly 600 medical colleges and universities. The Indian Bioethics Program of UNESCO Chair has established a robust program with a network of bioethics units in government and private medical colleges. The Indian Medical Association and Medical Council of India are collaborating in the Chair's program of implementing a bioethics curriculum and providing training for teachers of bioethics. The Indian program has developed and piloted a culturally relevant bioethics curriculum based on the UNESCO Core curriculum that is being used in over 200 institutions worldwide. "The focus is on training our own students as well as students in SAARC countries in bioethics, which is an integral yet deeply neglected part of our field. Having an active program will benefit patients and their families in understanding the nature of their illness, and aid in making decisions periodically that address the complexity of the process of providing healthcare. We in SAARC countries are still very top down in our practice of medicine. "We dictate what a patient should or shouldn't do, and that robs the patients of their voice, and goes against the standards of ethical conduct. Having an expert committee designing and implementing strategies for ethical conduct and drawing the line when it comes to medical treatment -- that is, taking into consideration what the family and patient want - will help us set up a more egalitarian healthcare system," said Dr Prem Nair, Medical Director of the Amrita Institute of Medical Sciences. ]]> <![CDATA[Trio of exciting new drugs to ignite bladder cancer treatment market by 2017]]> https://biospectrumindia.com/features/95/7385/trio-of-exciting-new-drugs-to-ignite-bladder-cancer-treatment-market-by-2017.html https://biospectrumindia.com/features/95/7385/trio-of-exciting-new-drugs-to-ignite-bladder-cancer-treatment-market-by-2017.html Mon, 18 Jan 2016 15:03:10 +0530 The bladder cancer treatment market is set to boom from an estimated $177.1 million in 2015 to over $646.6 million in 2017, as the launch of three new therapies over the next two years revitalizes a largely stagnant arena, according to research and consulting firm GlobalData. The company's latest report states that the growth, which will occur across the 6 Major Markets (6MM) of the US, France, Germany, Italy, Spain and the UK, will be primarily down to the introduction of Telesta Therapeutics' MCNA and Roche's atezolizumab in 2016 and Bristol-Myers Squibb's Opdivoin 2017. Dr Cai Xuan, GlobalData's Analyst covering Oncology, says: "Atezolizumab is on track to launch in the bladder cancer therapeutics space towards the end of 2016, and is one of many pipeline immune checkpoint inhibitors. This class of drugs has ignited substantial enthusiasm in recent years, as it has already shown efficacy in other difficult-to-treat cancers, including metastatic melanoma and lung cancer. "As atezoliuzumab will be the first therapy of its kind to launch in this market, it will have a significant advantage, explaining why sales of the drug are forecast to account for 43.7% of the treatment space by 2017." GlobalData's report also states that despite the clear the potential that the bladder cancer treatment market presents, there are several barriers that may inhibit growth. Dr Xuan explains: "Firstly, the majority of bladder cancer patients are over the age of 60, meaning that if they live in the US, they are entitled to receive insurance coverage through Medicare, which may negotiate lower drug prices through the pending Medicare Prescription Drug Price Negotiation Act. "Secondly, reimbursement decision-makers, such as the UK's National Institute for Health and Care Excellence (NICE), have rejected drugs developed for bladder cancer in the past on the basis of cost effectiveness, which means new entrants will need to demonstrate significant improvements in efficacy over existing standards-of-care to substantiate any premium price claims." Of the drugs launching in the 6MM by 2017, GlobalData expects atezolizumab and Opdivo to meet reimbursement criteria, on the assumption that they will be viewed as effective and more tolerable alternatives for metastatic patients, compared with the current treatment options of GemCis and Javlor. ]]> <![CDATA[Hot Start-up: 'Once the pinch starts.... ']]> https://biospectrumindia.com/features/95/7695/hot-start-up-once-the-pinch-starts-.html https://biospectrumindia.com/features/95/7695/hot-start-up-once-the-pinch-starts-.html Mon, 18 Jan 2016 12:29:19 +0530 Started in 2011, Bangalore-based Cabis Labs (Chemical And Biological Industrial Services) is a research-based, technology and product development start-up for the pharmaceutical industry. It is also a contract research venture primarily focused on drug discovery, development and manufacturing of pharmaceutical and pharma intermediates including specialty chemicals, APIs, and research chemicals. Dr Rajesh Kavali, MD and co-founder of Cabis, was a former scientist with Syngene International. He has also been a scientist with Sigma Aldrich and Zydus Cadila. "Bureaucracy," says Dr Rajesh, "is a major hurdle while establishing start-ups. Even for a small licensing chore you need to bribe a few people. In the US, if you want to establish an enterprise, there are organizations that are very supportive and they do not charge a penny. Such set-up is not available here in India. Even the Government doesn't support new ideas, and it doesn't understand the concept of entrepreneurship. Taxation eats away a lot of money in a start-up." He adds that approaching banks for funding is difficult even with great projects in hand. "Biotech start-ups take a minimum of 4 to 5 years to see returns. Profits come post that period. Most investors crave for immediate returns and are impatient," he points. Cabis bagged its first project only 2 years after its inception. "Our greatest asset is intellectual property. During the first year, it was all about groundwork, getting the projects, meeting and networking with people," reveals Dr Rajesh. Its first project was with Sigma Aldrich, whose support he very much cherishes. "We have also approached US companies. They can fund us, and we can exclusively work for them with mutual agreements including IPs," he shares. He says that in today's high-tech world, it is crucial for start-ups to have their own web presence. "Without a good branding, professionally crafted website, or even an email ID for that matter, one can go nowhere in the business world," Dr Rajesh notes. He mentions that Mr Somasundaram, MD of Supraveni Chemicals, an enterprise worth Rs 20 crore, was a great motivation to him. "Once the pinch starts, success automatically multiplies. When success multiplies, there are many who want to throw stones. But we have taken it up as a challenge," he opines. He states that he has learnt to be extremely patient in the biotech field. "Success will not happen in a year or two. It is important to maintain funds and a steady cashflow. It is crucial to minimize your desires and not needs. It is better to set shorter goals which will boost self-confidence. There is a lot of sacrificing that an entrepreneur has to make. He or she has to be ready to even sweep and clean the floor at times. But one has to learn to enjoy being an entrepreneur. Everybody in a start-up needs to work for its growth because everybody is an owner in it. Each individuals' idea should be respected," he explains. Talking about the industry's recent trends, he points that many companies are working on curing diseases at early embryonic stages in humans. "Companies in the US are already working on this, but not in India. Some gene expressions happen at a particular age. Certain diseases, however, can be controlled at embryonic stages when the expression happens during this stage," he observes. Dr Rajesh is an avid reader and loves playing badminton. "Entrepreneurs should read as many books as possible, whether it is on entrepreneurship or management or self-help books. Once you are able to convince yourself, you will be able to convince anyone, and that is going to boost your confidence," he ends. ]]> <![CDATA[Parkinson's disease treatment pipeline holds significant potential for patients and investors]]> https://biospectrumindia.com/features/95/7032/parkinsons-disease-treatment-pipeline-holds-significant-potential-for-patients-and-investors.html https://biospectrumindia.com/features/95/7032/parkinsons-disease-treatment-pipeline-holds-significant-potential-for-patients-and-investors.html Thu, 14 Jan 2016 12:45:00 +0530 According to the company's latest report, the current Parkinson's disease treatment market relies on neuromodulators, and although levodopa and dopaminergic treatments can be used to relieve symptoms, there is not an agent that has demonstrated neuro-protective properties to prevent or at least significantly slow neuronal cell death. However, Ms Angel Wong, Senior Analyst for GBI Research, states that the pipeline for the disease is highly active, consisting of 365 programs across all stages of development, and a diverse range of molecular targets. Ms Wong says: "The Parkinson's disease treatment pipeline is characterized by a high level of innovation compared to the central nervous system segment and the industry as a whole, with 43% of all pipeline programs with disclosed molecular targets being first-in-class. "While neuromodulators remain dominant in the pipeline, there are a number of targets which address different pathogenic mechanisms underlying neuro-degeneration in Parkinson's disease. This demonstrates a shift from traditional symptomatic treatments to disease-modifying therapies." The analyst adds that as the majority of potentially disease-modifying treatments are in the early stages of development, they are expected to fulfill a huge unmet need in the Parkinson's disease treatment market in the long term. GBI Research's report also states that there are 94 first-in-class products available for strategic consolidations, meaning a vast number of investment opportunities are available for licensing or co-development deals in Parkinson's disease therapeutics. Ms Wong explains: "There is substantial focus on early-stage collaboration in Parkinson's disease treatment, especially for first-in-class products. This is predominantly driven by growing unmet needs, the current lack of disease-modifying therapies and a desire for risk-sharing. "Several first-in-class products have demonstrated promising preclinical evidence, and have significant potential to become game-changing products, representing high-reward investments." ]]> <![CDATA[Piramal sells its cartilage repair product]]> https://biospectrumindia.com/news/95/3513/piramal-sells-its-cartilage-repair-product.html https://biospectrumindia.com/news/95/3513/piramal-sells-its-cartilage-repair-product.html Thu, 14 Jan 2016 11:58:23 +0530 Piramal Enterprises announces the sale of BST-CarGel from Piramal Healthcare (Canada) Limited, based in Montreal, Canada to Smith and Nephew, the global medical technology business. BST-CarGel is a first-line cartilage repair product used along with microfracture and other bone marrow stimulation techniques for the initial treatment of most sizes of focal cartilage tears. Through this transaction, an affiliate of Smith and Nephew will acquire ownership of all product and intellectual property assets related to BST-CarGel. The transaction does not have a material impact on the financials of Piramal. ]]> <![CDATA[Health professionals to adopt GREEN insulin injection technique ]]> https://biospectrumindia.com/news/95/6956/health-professionals-to-adopt-green-insulin-injection-technique-.html https://biospectrumindia.com/news/95/6956/health-professionals-to-adopt-green-insulin-injection-technique-.html Thu, 14 Jan 2016 10:38:38 +0530 FIT Insulin Injection Day was observed in Delhi and other parts of the country, with the adoption of FIT2.0 India recommendations. Amongst other best practices, the recommendations emphasize safe disposal of insulin syringes and pen needles as a means to reduce environmental impact of modern diabetes management. On this occasion, the advisory board members of Forum for Injection Technique (FIT) India propagated the message of GO GREEN STAY FIT in line with the article on Green Diabetology published in Indian Journal of Endocrinology and Metabolism,IJEM (Indian J Endocrinol Metab. 2015 Nov-Dec; 19(6): 698-700 emphasizing the urgent need for proper disposal of insulin delivery sharp devices. As per the article, over 200 million insulin delivery devices are generated in India each year. Approximately 65 million Indians living with diabetes consume about 160 million insulin syringes and about 50 million pen needles annually, along with about 40 million syringes used for immunization. Most of these devices are disposed of under unsafe circumstances. Apart from this, roughly 9.6 crore (96,000,000) vials, cartridges and prefills are consumed in a 12-month period (6.7 crore vials, 2.5 cartridge and 0.7 disposable pens), adding to the burden of glass and plastic on the environment. The net amount of plastic generated from insulin syringes alone, each year is 600,000 kg. This excludes the plastic generated from more than 40 million pen needles used every year in India. It is worrisome that most of these devices are not disposed off safely subjecting the care-taker and the community to health risks "While modern insulin technique guidelines address the need for appropriate disposal of needles and syringes, safe disposal of insulin delivery sharps is seldom practiced in clinic and home care environment,"said Dr Sanjay Kalra, FIT advisory broad member and lead author of the IJEM 'Green Diabetology' article. Apart from environmental contamination, unsafe disposal is having an adverse impact on healthcare worker safety. As per CDC, every day more than 1000 healthcare workers in hospital setting are injured with a needle or other sharp device. This especially happens during insulin syringe / pen needle re-capping, intended for re-use. The WHO in the Policy Guidance released in February 2015, has identified the issue of re-use of syringes, accidental needle stick injury, unsafe sharps waste management. As per the FIT recommendations, biomedical diabetes care -related wastes need to recycled, not reused. This can not only prevent the spread of infections among waste handlers and end-users but also promote conservation and efficiency, and help in revenue generation for waste disposal sites. In an effort to address safe and environment-friendly insulin disposal, healthcare professionals will initiate a nation-wide movement for green diabetology GO GREEN STAY FIT, which shall aim towards safe disposal of Insulin syringes and pen needles and prevention of reuse or re-capping of Insulin Injecting devices to prevent accidental needle-stick injury The program will also sensitize diabetes care professionals to their responsibility toward the physical environment, while reinforcing the need for interdisciplinary cooperation between all stakeholders. "While modern insulin technique guidelines address the need for appropriate disposal of needles and syringes, safe disposal of insulin delivery sharps is seldom practiced in clinic and home care environment," said Prof S V Madhu, Professor & Head, Dept. of Medicine & Endocrinology, UCMS-GTB Hospital. FIT India is an autonomous organisation which supports people with diabetes using injectable therapies to achieve the best possible health outcomes that can be influenced by correct injection technique. ]]> <![CDATA[Indian MedTech innovators churning out affordable technologies]]> https://biospectrumindia.com/news/95/6958/indian-medtech-innovators-churning-out-affordable-technologies.html https://biospectrumindia.com/news/95/6958/indian-medtech-innovators-churning-out-affordable-technologies.html Thu, 14 Jan 2016 10:34:00 +0530 India is fast becoming the hub of medical device innovations and one of the positive aspects is that the government has been highly supportive of the activities in this vertical. Among the prominent names that serve as one of the examples of inclusive medical technology innovation in India is the Biodesign programme of the department of biotechnology (DBT). Under this initiative, several indigenous technologies have been developed to address unmet medical needs of India. As an outcome, more than 100 innovators have been trained. Several national and international patents have been filed. About 30 prototypes have been developed. 9 start-up companies have been established by the Fellows and interns of this programme. 13 technologies have been licensed and 9 start-up companies launched. International collaborations have been established with Stanford University, USA; QUT, Australia; and Tottori University, Japan. Biodesign programme is based on a novel approach of end-to-end process that begins with idea generation through clinical immersion up to commercialization by a multi-disciplinary team comprising a physician, engineer, product designer, and an entrepreneur. The aim is to develop simple, rapid, indigenous, low cost medical devices and implants by applying 4 components i.e. affordability, accessibility, availability and appropriateness. Another example is Healthcare Technology Innovation Centre (HTIC) established at IIT-Madras that is delivering innovations and technologies that are reaching the field through government and industry partnerships, bringing benefits to lives and our society. Biotechnology Industry Research Assistance Council (BIRAC) a public sector undertaking set-up by the department has supported nearly 300 Start-up's and SME"s and 150 young entrepreneurs for innovation, research and product development. The biotech startup scenario in India was transformed by BIRAC's flagship schemes- BIG, SBIRI, BIPP, CRS and SPARSH which have resulted more than 30 Products, 20 Technologies, 16 Early Stage-Technologies. 2 Process Innovations, 40 IP. Nearly 100 Young Entrepreneurs have been supported for Med-Tech Innovation and more than 10 Med-Tech Products (devices and diagnostics) supported by BIRAC have been commercialized. Some of the products commercialized or in the process of commercialization include: a) Fecal Incontinence-a new standard of care for management of fecal incontinence; b) Cardio Pulmonary Resuscitation Device-an integrated automated resuscitation system usable in resource constrained environment;c) BioScoop-a soft tissue biopsy device for concurrent biopsy and hemostasis; d) HiCare LIMO:a simple, disposable and cost effective device which temporarily immobilizes the lower limbs of the patients; e) Intraosseous device-an alternative to intravenous (IV) in emergency patients; f) AINA device-to measure blood glucose, HbA1C, lipids, Creatinine and Haemoglobin; g) Maxico for tumor ablation-device for execution procedure for tumor ablation; h) POC diagnostic for Malaria, Dengue & Typhoid; i) Fibroheal-a device for burn wound management. New Products launched by the department of biotechnology (DBT) Name of the Product DescriptionConsure A new standard of care for the short term management of fecal incontinence.Intraosseous Device To gain quick access to circulation in clinical emergencies.LIMO A better way to temporarily immobilize injured lower limbs in trauma patients before they receive definitive care.Sohum A novel device to screen newborns for helping loss in resource poor settings to provide timely intervention and prevent speech loss.Neobreathe A way to empower front line health workers to resuscitate newborns effectively.Transfer life A simpler way to transfer non ambulatory patients from one bed to another.Noxeno An easier way to remove anterior foreign body from the nose without the need for general anesthesia in a primary care setting.Bioscoop A safer and simple way to perform percutaneous liver biopsy for definitive diagnosis.Hansure Simplifying hand hygiene in hospitals with improved accessibility and functionality.Uthishtami An uplift device to help elderly rise independently from a sitting position.Accufeed An accurate way to insert nasogastric tube in patients with neurological dysphagia.Thorashield A safer way to perform pleural tapping in patients with pleural effusion in order to reduce the complications during the procedure.Saakar kit An efficient way to distribute medications to patients in the resource constrained settings in order to minimize mismanagement of medication.D.Rx A mobile application to quickly reference names, dosages and prices of drugs sold in India.Brun A way to assess fetal wellbeing labour in resource constrained settings to reduce intrapartum stillbirths and neonatal deaths.pleuraGoh A way to secure intercostal drain in tube thoracostomy patients in order to prevent iatrogenic recurrent pneumothorax.Flexicast A way to immobilize the fractured limb with a uniform distribution of pressure and aeration in order to prevent skin ulcers and skin discomfort during the cast.Spinaflex A method to reduce stress on the back in dentist during dental procedures in order to lessen the risk of work related musculoskeletal disorders. Sphinx A novel ostomy appliance that empowers the user by providing better control over their bowel evacuation.Call Ambulance A mobile based solution to connect to emergency medical services in the fastest possible manner in India.Chest Compression Device An effective and consistent way to deliver chest compressions to sudden cardiac arrest (SCA) victims. Source: Department of Biotechnology ]]> <![CDATA[India aims to capture 10% of global MedTech market by 2025]]> https://biospectrumindia.com/news/95/8454/india-aims-to-capture-10-of-global-medtech-market-by-2025.html https://biospectrumindia.com/news/95/8454/india-aims-to-capture-10-of-global-medtech-market-by-2025.html Wed, 13 Jan 2016 17:08:15 +0530 According to the union minister for science and technology, Dr Harsh Vardhan, who spoke at a press conference held at New Delhi on January 12, 2016, "The 'Make in India' initiative led by Prime Minister, Narendra Modi aims to transform the country and propel the country to greater heights. Innovation in health care and medical technology is especially of paramount importance and can accelerate the country's social and economic growth." Dr Vardhan commended the department of biotechnology (DBT) for spearheading biomedical research in the country since its inception and he appreciated its remarkable achievements which has led to the improvement of the lives of millions (lakhs) of Indians. The minister shared details on new affordable products developed which are of societal and public health relevance in the presence of Dr Vijay Raghavan, secretary, DBT, and other senior DBT officials. Few key points were: â€¢ Medical Technology industry in India is currently the fourth largest in Asia; and India was valued at $6.3 billion in 2013 â€¢ Growing at 10-12% per year until 2025 implies an overall healthcare spend of $250-350 billion; â€¢ Current penetration levels of 8% implies a domestic market of $20-25 billion;â€¢ Globally the medical technology market is expected to be $600 billion by 2025 implying a manufacturing base of $200 billion by then; â€¢ India will capture 10% of that share by 2025 in line with China's share today. This will lead to an opportunity of atleast $20 billion by 2025;â€¢ Indian device market consists of medical instruments, orthopaedic and ophthalmic devices, syringes, needles, catheters, scanning devices and bandages; Realizing the need for medical technology innovation, the DBT is promoting this sector by supporting various programmes across the country which have successfully resulted in affordable products of societal and public health relevance. This area has seen a large number of successful scientists' entrepreneurs and young start-ups building their own enterprises. The complete value chain form product innovation to commercialization has been facilitated and today we have about 40 medical devices and diagnostics some of which have received USFDA clearances. ]]> <![CDATA[AstraZeneca, Incyte enter clinical trial collaboration]]> https://biospectrumindia.com/news/95/7750/astrazeneca-incyte-enter-clinical-trial-collaboration.html https://biospectrumindia.com/news/95/7750/astrazeneca-incyte-enter-clinical-trial-collaboration.html Wed, 13 Jan 2016 16:38:15 +0530 AstraZeneca and Incyte Corporation has announced a new collaboration to evaluate the efficacy and safety of Incyte's Janus-associated kinase (JAK) 1 inhibitor, INCB39110, in combination with AstraZeneca's next generation epidermal growth factor receptor (EGFR) inhibitor, Tagrisso (osimertinib). The combination will be assessed as a second line treatment for patients with EGFR mutation-positive non-small cell lung cancer (NSCLC), who have been treated with a first generation EGFR tyrosine kinase inhibitor (TKI) and subsequently developed the T790M resistance mutation. There is increasing evidence that signalling through the JAK-STAT (signal transducer and activator of transcription) pathway could be a contributing factor in resistance to EGFR TKI treatment in patients with EGFR mutation NSCLC. Blocking both JAK and EGFR activity may therefore offer an improved targeted treatment benefit in some patients. Under the terms of the agreement, AstraZeneca and Incyte will collaborate on a Phase I/II study, to be conducted by Incyte. The Phase I part of the trial is expected to establish a recommended dose regimen for the combination of INCB39110 and Tagrisso, while the Phase II part of the study will assess the safety and efficacy profile. Results from the study will be used to determine whether further clinical development of this combination is warranted. Mr Antoine Yver, head of oncology, global medicines development at AstraZeneca said, "We are pleased to be building on our existing relationship with Incyte and exploring a potentially exciting combination for lung cancer patients who have developed a resistance to first generation EGFR inhibitor treatment. This collaboration allows us to explore further ways in which Tagrisso, our first in class T790M-directed tyrosine kinase inhibitor, can help meet urgent unmet patient need, following its accelerated approval in the US and the recent positive CHMP opinion, recommending approval in Europe." Dr Rich Levy, chief drug development officer of Incyte said, "The expansion of our research collaboration with AstraZeneca will allow us to further our understanding of these two compounds and explore their potential synergies which support our goal of delivering innovative medicines that will benefit patients with cancer or other diseases. We look forward to adding to our ongoing clinical research for INCB39110 and exploring the potential of this combination." This agreement builds on an existing collaboration between the two companies, announced in May 2014, to explore AstraZeneca's anti-PD-L1 immune checkpoint inhibitor, durvalumab, in combination with Incyte's oral indoleamine dioxygenase-1 (IDO1) inhibitor, epacadostat (INCB24360). ]]> <![CDATA[Five polio-free years in South-East Asia Region: WHO]]> https://biospectrumindia.com/news/95/8042/five-polio-free-years-in-south-east-asia-region-who.html https://biospectrumindia.com/news/95/8042/five-polio-free-years-in-south-east-asia-region-who.html Wed, 13 Jan 2016 16:37:54 +0530 The United Nations health agency announced that the South-East Asia Region has completed five years without any case of wild polio virus, a highly infectious disease that invades the nervous system and for which there is still no cure. "This is a remarkable achievement in view of the continued threat of poliovirus importation from the remaining polio-endemic countries," said World Health Organization (WHO) regional director, Dr Poonam Khetrapal Singh, in a statement. "Countries in the region have been making commendable efforts, stepping up vigilance against polio and continuing to protect children against the crippling virus," She added, noting that the last case of wild poliovirus reported by WHO in the South-East Asia Region was in West Bengal, India, in 2011. The UN agency is underlining that completing half a decade without any case of wild polio virus is "yet another achievement" and a reminder that efforts need to continue until the disease is eradicated globally. "We need to ensure that our efforts and investment over the years to eradicate polio do not go to waste," warned Dr Singh. "Globally, polio transmission is at its lowest ever levels. However, the risk of importation of the poliovirus into all polio-free areas persists." As part of the Polio End Game strategy, a long-term plan that addresses what is needed to deliver a polio-free world by 2018, countries in the region are accelerating the introduction of one dose of injectable inactivated polio vaccine (IPV) in childhood immunization schedules, along with plans for a globally synchronized, phased and sequential withdrawal of oral polio vaccines from the programme. WHO says these strategies are aimed at addressing all polio - including the rare cases of vaccine derived polio. "Our efforts to stop polio and now to keep the region polio-free, have been possible due to numerous innovative strategies that helped strengthen immunization and disease surveillance, and promote community ownership," Dr Singh explained. "While these lessons learnt are now being adopted by the remaining endemic areas, countries in the region need to replicate these strategies and optimally use the polio programme resources for other public health goals, particularly in the areas of immunization, surveillance and emergency response." He added that a polio-free world "is in sight," and that the international community must continue to make efforts to rid the world of the "crippling disease." WHO's South-East Asia Region comprises Bangladesh, Bhutan, Democratic People's Republic of Korea, India, Indonesia, Maldives, Myanmar, Nepal, Sri Lanka, Thailand and Timor-Leste. ]]> <![CDATA[CCI nod for Strides-Sun Pharma deal ]]> https://biospectrumindia.com/news/95/7807/cci-nod-for-strides-sun-pharma-deal-.html https://biospectrumindia.com/news/95/7807/cci-nod-for-strides-sun-pharma-deal-.html Wed, 13 Jan 2016 11:54:36 +0530 Strides Shasun has received approval from Competition Commission of India (CCI) to acquire Sun Pharmaceutical's two business divisions in India. CCI in a tweet said it has approved "acquisition of certain assets and business of Sun Pharmaceutical by Strides Shasun Limited." In September last year, Sun Pharmaceutical announced that it has entered into a definitive agreement with Bangalore-based pharma company Strides Arcolab, to sell erstwhile Ranbaxy's Solus and Solus Care divisions operating in the central nervous system (CNS) segment in India. The agreement involved transfer of the two marketing divisions, along with employees to Strides for a consideration of Rs 1,650 million. In 2014, Sun acquired Daiichi Sankyo's Ranbaxy for a $4 billion deal. ]]> <![CDATA[Merck buys IOmet Pharma, expands Immuno-Oncology development program ]]> https://biospectrumindia.com/news/95/3542/merck-buys-iomet-pharma-expands-immuno-oncology-development-program-.html https://biospectrumindia.com/news/95/3542/merck-buys-iomet-pharma-expands-immuno-oncology-development-program-.html Wed, 13 Jan 2016 11:54:19 +0530 Merck, known as MSD outside the United States and Canada, announced that it has acquired IOmet, a privately-held UK-based drug discovery company focused on the development of innovative medicines for the treatment of cancer, with a particular emphasis on the fields of cancer immunotherapy and cancer metabolism. Under terms of the agreement, Merck, through a subsidiary, will acquire IOmet, including its comprehensive pre-clinical pipeline of IDO (indoleamine-2,3-dioxygenase 1), TDO (tryptophan-2,3-dioxygenase), and dual-acting IDO/TDO inhibitors. Based on the transaction, IOmet will become a wholly owned subsidiary of Merck. "By harnessing the power of the immune system, we are already witnessing great advancements in the treatment of cancer," said Dr Eric Rubin, vice president and therapeutic area head, oncology early-stage development, Merck Research Laboratories. He added, "The acquisition of IOmet is a further example of Merck's commitment to fully realizing the potential of this rapidly evolving field through our existing innovative portfolio as well as the acquisition of promising immunotherapeutic candidates." "Merck's leadership in immuno-oncology and expertise in development combined with the potential of our IDO1 and TDO programs creates significant opportunity for us to advance the treatment of cancer," said Dr Alan Wise,CEO, IOmet. He added, "As a company we have benefited from proximity to world class life sciences research including the University of Dundee, an early stage collaborator with us on the IDO1 and TDO programs and from supportive shareholders including the Scottish Investment Bank. We now look forward to joining Merck and feel that this acquisition underscores the shared commitment we have to accelerating our programs to bring solutions to people who need them most." Financial terms of the acquisition were not disclosed. ]]> <![CDATA[Aurobindo's new generic wins FDA approval]]> https://biospectrumindia.com/news/95/5526/aurobindos-new-generic-wins-fda-approval.html https://biospectrumindia.com/news/95/5526/aurobindos-new-generic-wins-fda-approval.html Tue, 12 Jan 2016 12:17:20 +0530 Aurobindo Pharma has announced that the company has received final approval from the US Food and Drug Administration (USFDA) to manufacture and market Norethindrone Acetate Tablets USP, 5mg. The approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) Aygestin Tablets, 5 mg, of Duramed Pharmaceuticals. Norethindrone Acetate Tablet is used in the treatment of endometriosis, uterine bleeding caused by abnormal hormone levels, and secondary amenorrhea. The approved product has an estimated market size of $24 million for the twelve months ending November 2015 according to IMS. ]]> <![CDATA[Shire bags Baxalta for $32 billion ]]> https://biospectrumindia.com/news/95/6418/shire-bags-baxalta-for-32-billion-.html https://biospectrumindia.com/news/95/6418/shire-bags-baxalta-for-32-billion-.html Tue, 12 Jan 2016 11:34:34 +0530 Shire and Baxalta announced that the boards of directors of both companies have reached an agreement under which Shire will combine with Baxalta. Under the agreement, Baxalta shareholders will receive $18.00 in cash and 0.1482 Shire ADS per Baxalta share. Based on Shire's closing ADS price on January 8, 2016, this implies a total current value of $45.57 per Baxalta share, representing an aggregate consideration of approximately $32 billion. The parties expect the transaction to close mid-2016. Shire CEO Dr Flemming Ornskov, said, "This proposed combination allows us to realize our vision of building the leading biotechnology company focused on rare diseases. Together, we will have leadership positions in multiple, high-value franchises and become the clear partner of choice in rare diseases. Our expanded portfolio and presence in more than 100 countries will drive our growth to over $20 billion in anticipated annual revenues by 2020. Our due diligence has reinforced our belief in the combination, and we look forward to welcoming Baxalta colleagues to a shared entrepreneurial, patient-driven culture." Baxalta CEO Dr Ludwig N Hantson, said, "Today's announcement marks a new path forward for our organization and is a testament to the significant progress we have made in achieving our strategic business priorities. This transaction presents a unique opportunity for Baxalta shareholders, who will receive substantial immediate value as well as an ongoing stake in a combined global leader in rare diseases with strong growth prospects. We bring to Shire a strong portfolio and pipeline of market-leading products, high-quality manufacturing capabilities and a talented global workforce that places patients at the center of everything we do. The combined organization will be well positioned to accelerate innovation and deliver enhanced value for all stakeholders." The combination of Baxalta and Shire will create the number one rare diseases platform in revenue and pipeline depth, with best-in-class products in each of the following growing, multi-billion-dollar franchises: Hematology; Immunology; Neuroscience; Lysosomal Storage Diseases; Gastrointestinal / Endocrine; and Hereditary Angioedema (HAE). The combined portfolio will have an expanded range of therapeutic areas with more than 60 programs in development, including over 50 that will address rare diseases and the newly-approved Baxalta products ADYNOVATE, VONVENDI and OBIZUR. Shire anticipates more than 30 recent and planned product launches from the combined pipeline, contributing approximately $5 billion in annual revenues by 2020. Further, the combined company will benefit from expanded geographic reach across more than 100 countries, with a high-quality commercial organization and world-class manufacturing. ]]> <![CDATA[CHMP recommends marketing authorization for AZ's Osimertinib]]> https://biospectrumindia.com/news/95/6037/chmp-recommends-marketing-authorization-for-azs-osimertinib.html https://biospectrumindia.com/news/95/6037/chmp-recommends-marketing-authorization-for-azs-osimertinib.html Mon, 11 Jan 2016 14:47:30 +0530 AstraZeneca announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion, recommending the marketing authorisation of osimertinib 80mg once-daily tablets for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor (EGFR) T790M mutation-positive non-small cell lung cancer (NSCLC). This indication includes NSCLC patients whose disease has progressed on or after treatment with an EGFR tyrosine kinase inhibitor (TKI) and patients with a T790M mutation who have not been treated with an EGFR-TKI. Dr Sean Bohen, Executive Vice President, Global Medicines Development and Chief Medical Officer at AstraZeneca, said: "The CHMP's recommendation for osimertinib to receive marketing approval is a positive step for patients in Europe. This follows the recent US accelerated approval of osimertinib and its adoption in the UK under the "Early Access to Medicines Scheme to meet urgent unmet need. Building on the breakthrough clinical evidence, we're investigating osimertinib's full potential as a monotherapy and in novel combinations with other precision medicines and immunotherapies from our comprehensive oncology pipeline." AURA study clinical investigator Professor Jean-Charles Soria, Head of Drug Development Department, Gustave Roussy Cancer Center, Paris, France, added; "In Europe, lung cancer kills over 260,000 people every year, so there is an urgent need for new treatments. As a treating physician, it is very gratifying to see the progression of osimertinib towards use in clinical practice for patients living with EGFRm T790M non-small cell lung cancer." Osimertinib is an EGFR-TKI designed to inhibit both the activating, sensitising mutation (EGFRm), and T790M, a genetic mutation responsible for EGFR-TKI treatment resistance. Nearly two-thirds of patients with EGFRm NSCLC whose disease progresses after EGFR-TKI treatment develop the T790M resistance mutation, for which treatment options are limited. The CHMP recommendation for osimertinib is based on data from two Phase II studies (AURA extension and AURA2) and the AURA Phase I expansion study, which demonstrated efficacy in 474 EGFRm T790M NSCLC patients who had progressed on or after an EGFR-TKI. In the combined Phase II studies, the objective response rate (ORR, a measurement of tumor shrinkage) was 66%, and in the Phase I study it was 62%. Progression-free survival (PFS) was 9.7 months in the combined Phase II studies and 11 months in the Phase I trial. Median duration of response (DOR) in the Phase I study was 9.7 months and in the combined Phase II studies, median duration of response was not reached. The most common adverse events based on data from the two AURA Phase II studies were generally mild to moderate and included diarrhoea (42% all grades; 1.0% Grade 3/4), rash (41% all grades; 0.5% Grade 3/4), dry skin (31% all grades; 0% Grade 3/4), and nail toxicity (25% all grades; 0% Grade 3/4). Warnings and precautions include interstitial lung disease, QT interval prolongation and embryofoetal toxicity. The positive CHMP recommendation has been received through the EMA's Accelerated Assessment and follows the recent US Accelerated Approval of osimertinib by the Food and Drug Administration (FDA). In Japan, osimertinib was granted Priority Review by the Pharmaceuticals and Medical Devices Agency (PMDA). Interactions with regulatory authorities in the rest of the world are ongoing. ]]> <![CDATA[Safer, more effective drugs will push vasculitis treatment market value to $558 mn by 2024]]> https://biospectrumindia.com/features/95/4475/safer-more-effective-drugs-will-push-vasculitis-treatment-market-value-to-558-mn-by-2024.html https://biospectrumindia.com/features/95/4475/safer-more-effective-drugs-will-push-vasculitis-treatment-market-value-to-558-mn-by-2024.html Mon, 11 Jan 2016 14:09:26 +0530 The vasculitis treatment market in the US and major European pharmaceutical markets (France, Germany, Italy, Spain, and the UK) is expected to expand in value over the next decade, from under $342 million in 2014 to over $558 million by 2024, at a Compound Annual Growth Rate (CAGR) of 5.1%, according to research and consulting firm GlobalData. The company's latest report states that the leading driver of this reasonably robust growth will be the anticipated launches of five biologics for the treatment of various forms of vasculitis, including Bristol-Myers Squibb's (BMS) Orencia, Johnson & Johnson's Remicade, GlaxoSmithKline's (GSK) Benlysta and Nucala, and Roche's Actemra. Ms Alexandra Annis, MS, GlobalData's Analyst covering Immunology, says: "The regulatory approval of these drugs throughout the forecast period will introduce four novel MOAs to the market, which will address current unmet needs well. "The greatest unmet needs in the vasculitis market are improved safety and efficacy for both induction and maintenance therapies, as induction regimens for the management of vasculitis typically come with a considerable list of side effects." Ms Annis explains: "The approval of biologics has the potential to result in big profits for pharma, as the cost of using them to treat a patient with vasculitis surpasses $16,000 per year. For this reason, vasculitis is an attractive area for label expansions." The analyst adds that Roche's Actemra, BMS's Orencia and GSK's Nucala are anticipated to be the most successful of the new vasculitis treatment market entrants, as they have demonstrated strong efficacy and safety in clinical trials. Despite this, there will be barriers preventing the vasculitis market from reaching its full growth potential during the forecast period. Ms Annis continues: "The high cost of biologics will limit their uptake, especially in cost-conscious markets that are facing austerity measures. Cheaper biosimilars will challenge established brands. "In addition, there will be challenges in gaining reimbursement of biologics approved as induction therapies for use as maintenance therapies, such as Rituxan." ]]> <![CDATA[Exempt Healthcare Services from GST: NATHEALTH]]> https://biospectrumindia.com/news/95/4068/exempt-healthcare-services-from-gst-nathealth.html https://biospectrumindia.com/news/95/4068/exempt-healthcare-services-from-gst-nathealth.html Mon, 11 Jan 2016 12:19:42 +0530 In line with the goal of achieving Universal Healthcare Coverage, NATHEALTH (Healthcare Federation of India), India's apex Healthcare body, presents pre-budget recommendations to the Govt. to exempt the healthcare services from goods and services Tax or GST. Mr Anjan Bose, secretary general, NATHEALTH said, "GST once implemented, would put various sectors under the purview of service tax. Healthcare is currently exempted from service tax and this should continue after the GST regime at least for a period of ten years and only thereafter should a decision to levy service tax be considered, after assessing the status of healthcare coverage, costs and performance on key healthcare metrics. Levying service tax on healthcare services and facilities will be a retrograde step which will push back the agenda to provide universal healthcare. The current stage of development of the healthcare industry cannot afford levy of service tax." He added, "Given the long payback period, extension of the tax holiday to ten years instead of five will improve the business case for investment. The lack of skilled healthcare resources in non-metros and tier 2, 3, 4 cities makes the payback period even longer." With the huge impact of NCD'S (Non-communicable diseases) on the Indian population it is absolutely imperative to increase the focus on prevention and preventive healthcare. WHO statistics clearly states that more than 52 lakh lives are lost annually in India alone. The death rate in urban India is expected to rise by 42 percent by 2021 out of which NCD alone will account for around 62 percent DALY (disability adjusted life year) losses. One person dies of a stroke every minute in India. Every 6th patient below 40 years is a victim of cancer and CVD. The Economic burden of NCDS in India will be 6.2 trillion USD from the period of 2016-2030. Highlighting the need to focus on preventive healthcare, Mr Bose stressed that in order to achieve the Government's stated objective of Universal health coverage, the tax exemption on Preventive Health checkup should be raised from the current Rs 5000/- to Rs 20000/- under section 80-D of Income Tax Act 1961. NATHEALTH recommends the government to withdraw service tax on Health Insurance Premium which acts as a deterrent to consumers. Healthcare is not taxed for services so the same principle should be applied for healthcare financing as well. Mr Sushobhan Dasgupta, president, NATHEALTH informed, we have urged the government to increase the depreciation rate applicable on medical and pathological equipment and medical devices from 15 percent to 30 percent. "At present corporate income tax incentives is given on capital expenditure for hospitals with 100 beds and above, which needs to be revised for Greenfield Hospitals with 50 beds. This initiative will extend benefits to smaller facilities and will encourage set up of more much-needed healthcare facilities in tier 2,3 and 4 cities," added Mr Dasgupta "We appeal to the Govt. to come out with policies that will enable the environment to fund long-term growth and help develop/optimize healthcare infrastructure," said Mr Sushobhan Dasgupta. Govt. should set up a healthcare infrastructure fund and a medical innovation fund which would encourage entrepreneurship and newer business models which are the need of the hour for improving access, availability and quality, especially in tier 2, 3 and rural areas. Govt. can consider providing seed capital for such fund emphasized Mr Dasgupta. "To bolster skill development in healthcare, Govt. needs to consider introducing special incentives for Health sector skill development and make it easier to collaborate with eminent overseas training partners. This would necessitate increased budgetary provisions for Healthcare sector skill council and relaxation of taxes on training aids and import of training materials," said Mr Bose. Considering the huge demand and supply gap of doctors, health sector needs strong incentives to set up medical colleges. Free and concessional land in setting up private medical colleges will incentivize more players to get into medical education. To encourage quality and innovation govt. should provide a longer term (10 year window) for 250 percent deduction of approved expenditure on R&D activities. Further Mr Anjan Bose said, "We are hopeful that in the upcoming budget the government will consider the recommendations for the entire healthcare value chain, which will result in progress of Indian healthcare sector." ]]> <![CDATA[Jubilant Biosys collaborates with Sanofi to develop metabolic disorders therapy]]> https://biospectrumindia.com/news/95/7599/jubilant-biosys-collaborates-with-sanofi-to-develop-metabolic-disorders-therapy.html https://biospectrumindia.com/news/95/7599/jubilant-biosys-collaborates-with-sanofi-to-develop-metabolic-disorders-therapy.html Mon, 11 Jan 2016 12:19:12 +0530 Jubilant Biosys, subsidiary of Jubilant Life Sciences, and Germany based Sanofi Deutschland have announced a strategic alliance to discover and develop small molecule inhibitors for multiple targets in the metabolic disorders therapeutic area. The research alliance is aimed at developing therapeutic small molecules that will address the unmet needs in diabetes and obesity. As per the terms of the agreement, Jubilant shall provide Sanofi integrated drug discovery and early development services across computational, synthetic chemistry, biology, GLP/ GMP services, to identify lead candidates and demonstrate clinical proof of mechanism in the metabolic disorders therapeutic areas. The research for the projects, which has been initiated, will be undertaken primarily at state-of-the-art R&D labs of Jubilant Biosys (Bengaluru, India) and Jubilant Chemsys (Noida, India). Dr Sriram Rajagopal, chief scientific officer, Jubilant Biosys said, "We are excited to partner with Sanofi, one of the global healthcare leader, to offer our integrated drug discovery solutions. Over the past few years, we have been strengthening our therapeutic area expertise in the scientific perspective and this collaboration is a validation of our efforts. This alliance demonstrates Jubilant's commitment to global innovation and we look forward to a long mutually beneficial partnership." Dr Philip Just Larsen, vice president, Global Head of Diabetes Research & Translational Medicine, Sanofi Deutschland said, "The collaboration with Jubilant underscores our commitment to engaging innovators around the world, as we develop the next generation of improved therapies for people with diabetes." ]]> <![CDATA[Allergan buys Anterios to expand neurotoxin pipeline]]> https://biospectrumindia.com/news/95/8061/allergan-buys-anterios-to-expand-neurotoxin-pipeline.html https://biospectrumindia.com/news/95/8061/allergan-buys-anterios-to-expand-neurotoxin-pipeline.html Mon, 11 Jan 2016 12:18:47 +0530 Allergan announced that it has acquired Anterios, a clinical stage biopharmaceutical company developing a next generation delivery system and botulinum toxin-based prescription products. Under the terms of the agreement, Allergan acquired Anterios for an upfront payment of $90 million and potential development and commercialization milestone payments related to NDS, Anterios' proprietary platform delivery technology that enables local, targeted delivery of neurotoxins through the skin without the need for injections. In addition to NDS, Allergan has acquired global rights to ANT-1207, an investigational topical formulation botulinum toxin type A in development for the potential treatment of hyperhidrosis (excessive sweating), acne, and crow's feet lines. The NDS platform technology and ANT-1207 add to Allergan's strong neurotoxin pipeline, with BOTOX Cosmetic (onabotulinumtoxinA) currently in development for treating forehead lines, masseter hypertrophy and platysma bands and BOTOX Therapeutic in development for osteoarthritis and depression. "The acquisition of Anterios bolsters Allergan's commitment to innovation and maintaining its leadership position in neurotoxin development and commercialization," said Mr David Nicholson, executive vice president and president, global brands research and development at Allergan. He added, "Our team at Allergan pioneered the development and commercialization of BOTOX, the market-leading neurotoxin used in both medical aesthetics and therapeutic areas of medicine. This acquisition demonstrates our ability to apply our tremendous scientific leadership in neurotoxins to further extend our already deep neurotoxin pipeline by advancing a new delivery system and formulations that are appealing to both patients and physicians." "Allergan has a long history in dermatology and aesthetics, a deep commercial and development network across these professional communities, and a strong commitment to innovation. They were the natural fit for us as we sought a partner to take our NDS platform technology and ANT-1207 program to the next stage of development and eventual commercialization," said Mr Jon Edelson, MD, CEO and founder of Anterios. Prior to the closing, Anterios spun out certain assets to a new company, Eirion Therapeutics, Inc., funded by Anterios shareholders. The new entity also retains certain non-exclusive rights to ANT-1207. ]]> <![CDATA[AIMED welcomes DOP's initiatives to establish medical devices industry in India ]]> https://biospectrumindia.com/news/95/7904/aimed-welcomes-dops-initiatives-to-establish-medical-devices-industry-in-india-.html https://biospectrumindia.com/news/95/7904/aimed-welcomes-dops-initiatives-to-establish-medical-devices-industry-in-india-.html Mon, 11 Jan 2016 10:46:49 +0530 AIMED has welcomed the department of pharmaceuticals (DOP) initiatives to establish Medical Devices industry in India and make it manufacturing hub of the world like pharma but points out that government needs to move beyond discussions and quickly bring out the promised new policy for medical device sector while resolving other pending issues to unleash the true potential. The Association has congratulated the government for coming out with this laudable initiative of DOP's in holding India's first ever Pharma and Medical device centric conference and exhibition and for reaching out to the industry with collaborative intentions. At the same time, AIMED has pointed out that government needs to move beyond discussions and exhibitions to unleash the true potential of the sector.During one hour brainstorming interaction with union minister of chemical and fertiliser Mr Ananth Kumar along with secretary, DoP and other joint secretaries from Ministry of Commerce, MoHFW etc with 16 CEO of Medical Devices Industry to drive manufacturing in India - AIMED raised six critical issues which needed immediate attention of the government to realize India's medical device manufacturing potential. AIMED has also given six key action points for the government to work upon. However, AIMED hs pointed out that the most urgent need of the hour was the unveiling of new policy for medical device sector. "We eagerly await the release of a medical device policy whose draft government had released in June," point out Mr Rajiv Nath, Joint Coordinator, AIMED. "The six issues includes forward looking recommendations which will facilitate creation of vibrant eco-system for medical device manufacturing in the country and reduce humungous import dependency. At the same time, AIMED has pointed out that recommendations on their own were not good enough to ensure desired objective of making India a powerhouse in manufacturing of medical devices." Mr Nath has also drawn attention to long standing and vexing issues such as withdrawal of concessional duty regime, ensuring equitable tariff regime between domestically produced goods and imports to ensure commercial and competitive viability of goods made in India. Till the time, it is cheaper to import, why would anyone invest their time, energy and money in a loss making venture, wondered Mr Nath. He has pointed out that along with zero duty on raw materials, duty on finished imported goods needs to be raised to maximum level to dis-incentivize import based trading and attract foreign investments for manufacturing in India. Mr Nath has also drawn attention to medical device industry's long drawn demand to have a separate 'Dept of Pharmaceutical and Medical Devices ' within a Ministry of Healthcare, apart from the much needed separate regulatory regime for medical devices. Mr Nath has emphasized that there must be separate departments for medical devices and pharmaceuticals working under the same ministry which could be called Ministry of Life Sciences or Ministry of Healthcare Products. He has pointed out that housing both departments for being a facilitating body and attaching an autonomous regulatory body under one coordinating minister would be the most desirable step for faster decision making."We need one ministry for both medical devices and pharmaceuticals on the line of AYUSH," said Mr. Nath. He has strongly recommended bringing an altogether new Act for Medical Devices rather than a new chapter being added to the existing Drugs and Cosmetics Act, 1940.Medical Devices are absolutely different category of products from pharmaceutical, though under the common 'Healthcare' vertical. For some strange reason we have been governed by Drugs and Cosmetics Act, 1940, which as thwarted the growth of medical device industry in India," pointed out Mr. Nath. "Now that government is committed to creating a vibrant medical device manufacturing eco-system, then an altogether separate law book and rule book will be more business friendly and help attract investments," said Mr Nath. The new legislation also must ensure that traders and pseudo manufacturers are not permitted to pass-off as manufacturer, he said. Medical device industry also need separate regulator or revamped CDSCO as IHPRA - Indian healthcare products regulatory authority, added Mr Nath. Mr. Nath has said that recommendations regarding financial support to manufacturing units, reversal of inverted duty structure, MRP based taxation system, creation of a separate department and separate law for medical devices were of particular significance to give the required push for medical device manufacturing in the country.Welcoming earlier Task Force's recommendation to have a new medical device parks, Mr Nath pointed out that it was equally important that government invests in strengthening the infrastructure facilities at existing industrial clusters .He expressed hope that government would go extra mile to see that Task Force recommendations are implemented at the earliest by releasing a structured policy ."For 'Make in India' vision to be realized and to make India the factory of the world, these recommendations and additional measures need to be implemented at the earliest," said Mr Nath. ]]> <![CDATA[Glenmark's new monoclonal antibody targets oncology indication]]> https://biospectrumindia.com/news/95/6360/glenmarks-new-monoclonal-antibody-targets-oncology-indication.html https://biospectrumindia.com/news/95/6360/glenmarks-new-monoclonal-antibody-targets-oncology-indication.html Fri, 08 Jan 2016 12:48:55 +0530 Glenmark Pharmaceuticals SA (GPSA), a wholly owned subsidiary of Glenmark Pharmaceuticals Limited India (GPL), has announced the discovery and initiation of IND enabling studies for a novel clinical development candidate, GBR 1342. GBR 1342 is a CD38xCD3 bispecific antibody based on Glenmark's proprietary BEAT platform. GBR 1342 is the second clinical development candidate (following GBR 1302 a HER2xCD3 biâ€?specific antibody) based on the BEAT technology. It is also Glenmark's second clinical candidate targeting oncology indications. CD38 is one of the few known markers for plasma cells and is a wellâ€?established target for multiple myeloma, a cancer caused by malignant plasma cells. CD38 is potentially also a target for other hematopoietic malignancies. Commenting on this achievement, Dr Michael Buschle, chief scientific officer and president â€? Biologics, Glenmark Pharmaceuticals said, "GBR 1342 is the second biâ€?specific antibody emerging from our BEAT platform. With the 1302 project we learned how to efficiently engineer and manufacture this novel type of antibody and we are now applying those lessons to several other targets." GBR 1342's mode of action is similar to GBR 1302, Glenmark's first CD3 redirecting antibody. GBR 1342 redirects cytotoxic T cells through its CD3 binding arm onto CD38â€?expressing cancer cells and induces the killing of these cancer cells by the T cells. Glenmark is committed to moving GBR 1342 rapidly intoclinical trials. BEAT(Biâ€?specific Engagement by Antibodies based on the T cell receptor) is Glenmark's technology for production of biâ€?specific antibodies. Engaging two targets with one biâ€?specific antibody is a novel concept to design new therapeutics. ]]> <![CDATA[Lily's Elanco finalizes acquisition of Novartis animal health division ]]> https://biospectrumindia.com/news/95/6977/lilys-elanco-finalizes-acquisition-of-novartis-animal-health-division-.html https://biospectrumindia.com/news/95/6977/lilys-elanco-finalizes-acquisition-of-novartis-animal-health-division-.html Fri, 08 Jan 2016 12:48:31 +0530 The acquisition, announced in April 2014, follows Elanco's purchase of Lohmann Animal Health earlier in 2014. Both strategic investments position the company to offer a more diversified product offering and capabilities to help customers sustain and grow their businesses. This includes the flagship brands customers have come to expect from Elanco, but also a comprehensive portfolio of nearly 300 brands encompassing therapeutics, vaccines, parasiticides, antimicrobials, surgical, enzymes, food safety and more. "Elanco's acquisition of Novartis Animal Health brings together two strong companies with a passion for serving the customer," said Dr Velisetty Ashok Kumar, Country Director, Elanco India Private Limited. "We will continue to offer the products our customer's trust, while significantly investing in the development of new solutions to meet our customers' greatest unmet needs. We'll continually seek innovative ways we can support our customers' business. With increased technical services, that combine our analytic and benchmarking tools with on-the-ground support, we'll be able to spend more time with individual customers seeking innovative solutions that can make a difference in their business." Going forward, Elanco will significantly increase investment in research and development, bringing greater breadth and depth to an already strong pipeline. The combined organization will have expanded capabilities and expertise with a broader portfolio of more than 100 product development projects focused on enhancing care and extending quality of life of pets, while preventing disease and protecting from parasites. It is also aimed at protecting livestock from disease and parasites, improving animal well-being and reducing the environmental foot print of livestock production. The company also aims at providing a broader set of solutions in areas such as enzymes, diagnostics, aquaculture and vaccines. ]]> <![CDATA[Vaccine essential to conclusively end AIDS in countries like India ]]> https://biospectrumindia.com/news/95/7980/vaccine-essential-to-conclusively-end-aids-in-countries-like-india-.html https://biospectrumindia.com/news/95/7980/vaccine-essential-to-conclusively-end-aids-in-countries-like-india-.html Fri, 08 Jan 2016 12:16:11 +0530 Focused on the low- and middle-income countries (LMICs) across Africa and Asia that are home to the vast majority of the world's people living with HIV/AIDS, the study published in PLOS ONE shows that adding a vaccine could dramatically reduce new HIV infections and AIDS-related deaths even if other treatment and prevention tools are extensively scaled up. The analysis in the study shows that a 70-percent-effective AIDS vaccine with a strong uptake could reduce new annual HIV infections in LMICs by 44 percent in its first 10 years and 65 percent in 25 years, ultimately averting tens of millions of infections and saving millions of lives. It also demonstrates that an AIDS vaccine would be impactful and cost-effective across a wide range of product characteristics. Higher efficacy, longer-lasting protection, fewer doses, lower vaccine costs and a more effective rollout will increase both health impact and cost-effectiveness. "This study reaffirms how a safe vaccine could be instrumental in reducing the number of new infections and save millions of lives. This would significantly reduce the treatment costs and even reduce total response costs over time", said Dr Rajat Goyal, India country director at International AIDS Vaccine Initiative. He continues, "It is clear that we must continue to expedite development of an effective HIV vaccine alongside critical efforts to accelerate and sustain broad and equitable access to effective antiretroviral therapy and new approaches for pre-exposure prophylaxis (PrEP)." According to the latest information from the National Aids Control Organisation (NACO), India has around 21.17 lakh people living with HIV/AIDS, the third highest number of in the world. Out of this 40.5% percent of total HIV infections are among women. "Adding a vaccine to a comprehensive HIV/AIDS response will hasten the end of the global epidemic and ensure that it won't rebound," said Mitchell Warren, executive director, AVAC. "A safe, effective and affordable AIDS vaccine is an essential complement to the existing treatment and prevention options, and this study highlights why accelerated investments are needed for both implementation of what we have and the development of what we still need." This new study builds on the UNAIDS Investment Framework Enhanced, which articulates how accelerated scale-up of existing HIV/AIDS interventions and the addition of new prevention options could significantly change the trajectory of the global epidemic. It adds extensive analysis on the impact of key characteristics of a vaccine (efficacy, duration of protection, number of doses) and of vaccination programmes (how many people would be covered with how many visits, cost per regimen, etc.). The study was funded by the United States Agency for International Development (USAID), which administers the U.S. foreign assistance program providing economic and humanitarian assistance in more than 120 countries worldwide. ]]> <![CDATA[Mylan launches generic Hepatitis C drug]]> https://biospectrumindia.com/news/95/6419/mylan-launches-generic-hepatitis-c-drug.html https://biospectrumindia.com/news/95/6419/mylan-launches-generic-hepatitis-c-drug.html Fri, 08 Jan 2016 12:13:43 +0530 Mylan NV announced that its subsidiary, Mylan Pharmaceuticals Private Limited, has launched generic Harvoni (Ledipasvir 90 mg/Sofosbuvir 400 mg) tablets under the brand name MyHep LVIR in India. Mylan launches generic Harvoni (Ledipasvir/Sofosbuvir) under the brand name MyHep LVIR in the country. The Ledipasvir/Sofosbuvir combination is indicated for the treatment of Hepatitis C infection and offers a simplified Hepatitis C treatment regimen that eliminates the need for interferon and ribavirin. The product also is a single-tablet regimen and requires a therapy course of just 12 weeks. Harvoni has exhibited high cure rates and a tolerable side effect profile across a range of patient populations. Mylan president Mr Rajiv Malik said, "Mylan recognizes the urgent need to expand access to high quality, affordable Hepatitis C treatment options in India, where roughly 12 million people are infected with the virus. MyHep LVIRis an important addition to our growing Hepato Care segment in India that gives us the opportunity to offer patients the potential to be cured through a transformative and simplified single tablet, once-daily treatment regimen. Moreover, consistent with our commitment to create better health for a better world, we are introducing various educational initiatives in India to raise awareness of the disease and its treatment options." The launch of MyHep LVIR follows the successful launch of generic Sofosbuvir in India under the brand name MyHep in April 2015. In September 2014, Mylan entered into a licensing and technology transfer agreement with Gilead granting Mylan the non-exclusive rights to manufacture and distribute generic Sofosbuvir and Ledipasvir/Sofosbuvir tablets in 101 developing countries, including India. Mylan also entered into an agreement with Gilead in February 2015 as the exclusive distributor of Gilead's branded Sovaldi (Sofosbuvir 400 mg) and Harvoni tablets in India. Mylan launched Sovaldi in India in May 2015. ]]> <![CDATA[Global breast cancer treatment market to reach $17.2 bn by 2021]]> https://biospectrumindia.com/features/95/7940/global-breast-cancer-treatment-market-to-reach-17-2-bn-by-2021.html https://biospectrumindia.com/features/95/7940/global-breast-cancer-treatment-market-to-reach-17-2-bn-by-2021.html Thu, 07 Jan 2016 15:04:37 +0530 The global breast cancer therapeutics market is set to increase in value from $10.4 billion in 2014 to $17.2 billion by 2021, at a Compound Annual Growth Rate (CAGR) of 7.3%, according to business intelligence provider GBI Research. The company's latest report states that this strong growth will be primarily due to substantial increases in the prevalence of breast cancer, with rates of the disease expected to rise over the forecast period due to an aging population, changing lifestyles and higher survival rates. Furthermore, Ms Deekshita Allavarapu, Analyst for GBI Research, says that the introduction of several new therapies will help to drive breast cancer treatment market growth by 2021. She explains: "In terms of upcoming breast cancer treatments, the overall pipeline is strong, with 743 products, and the early pipeline has many experimental molecules designed to target novel pathways. "Promising pipeline drugs include abemaciclib, buparlisib, LEE 011, Olaparib and NeuVax, all of which are expected to be approved within the forecast period and have demonstrated significant clinical benefits in trials. In addition, rapid uptake of premium-priced biologics, such as Perjeta and Kadcyla, in all settings of the disease will contribute to the market growth." Despite this, the analyst notes that the late-stage breast cancer pipeline is weak, with only 6% of candidates in Phase III of development, and targeted therapies, currently unrepresented by marketed products, almost non-existent within this phase. GBI Research's report also states that the market will face some limitations due to patent expirations creating substantial opportunity for generic and biosimilar manufacturers. She continues: "The patents for a number of key breast cancer drugs, including Afinitor, Avastin and Herceptin, are expected to expire during the forecast period. However, the use of combinations of branded therapies in both the early-stage and metastatic settings will increase the Annual Cost of Therapy (ACoT) and offset the impact of patent expiries. "For example, the ACoT for the combination of Perjeta with Herceptin is three times that of Herceptin monotherapy in both adjuvant and metastatic settings in the US. Therefore, even though Herceptin is set to expire in the near future, this will be offset by the approval of newer combination therapies and the growth of current premium therapies." ]]> <![CDATA[The BioAg Alliance readies new microbial solution to improve corn harvests]]> https://biospectrumindia.com/news/95/6121/the-bioag-alliance-readies-new-microbial-solution-to-improve-corn-harvests.html https://biospectrumindia.com/news/95/6121/the-bioag-alliance-readies-new-microbial-solution-to-improve-corn-harvests.html Thu, 07 Jan 2016 13:50:00 +0530 The BioAg Alliance, Novozymes' and Monsanto's collaboration to improve crop harvests through naturally-occurring microbes, announced results from its 2015 field trial program. Those results included a corn inoculant product, which increased yields by an average of 4 bushels per acre in US field tests. The product is based on a fungus found in soil and researchers from the two companies have found a way to coat the microbes on corn seeds without harming the microbes' performance or longevity. The Alliance plans to launch the new solution in the United States in 2017. "The BioAg Alliance is focused on identifying ways that soil microbial solutions can deliver improved harvests from existing land," said Mr Brad Griffith, Vice President of Global Microbials for Monsanto. "This work is critically important to farmers as they work to meet demands and preserve their soil system. This breakthrough collaboration is unlocking new insights into soil microbial candidates to benefit farmers and our work with this corn seed inoculant is a great example of the results of our combined research." World's largest microbe research program Microbial-based solutions are derived from various microbes such as bacteria and fungi. The BioAg Alliance markets two types of microbial products: Inoculant products, which help plants with nutrient uptake, and biocontrol products, which help protect plants against pests and diseases. The products can be applied to seeds before planting, applied to growing crops or applied to soil in-furrow. The companies said that they can be used by farmers that grow broad acre crops such as corn and soy, and on fruits and vegetables. Microbial products can increase crop yields and can complement or replace agricultural chemicals and fertilizers. The BioAg Alliance is currently running the world's largest microbial research program to develop the next generation of these products. In 2015, the Alliance tested more than 2,000 microbial strains across 500,000 field trial plots in more than 50 locations in the United States. The companies said results from its US field trial program showed its top new microbes increased corn yields by an average of 4-5 bushels per acre and soy yields by an average of 1.5 bushels per acre. The BioAg Alliance expects to continue testing thousands of strains across a broad range of environments in extensive US field trials in 2016. "I believe we will witness a microbial revolution in agriculture", said Dr Thomas SchÃ¤fer, Vice President of BioAg research at Novozymes. "The world needs to produce more crops from our arable land while using fewer resources. The more we learn about microbes and their symbiotic relationships with plants, the more we realize how key they are to this challenge." Today, The BioAg Alliance's products are used on around 65 million acres, but Monsanto and Novozymes envision that their products will be used on 250-500 million acres globally by 2025. The agricultural market for microbials is estimated at $1.8 billion, while the market for traditional fertilizers and pesticides totals $240 billion. ]]> <![CDATA[Hottest Indian Start-ups: One-stop solution for protein and antibody]]> https://biospectrumindia.com/features/95/7418/hottest-indian-start-ups-one-stop-solution-for-protein-and-antibody.html https://biospectrumindia.com/features/95/7418/hottest-indian-start-ups-one-stop-solution-for-protein-and-antibody.html Thu, 07 Jan 2016 10:55:16 +0530 However, their unwavering self-belief, hard work and patience has started paying off. GNG was founded in 2011, with a focus in the areas of diagnostic and therapeutic proteins development, cellular and molecular assay development and contract research services. The company has expertise in protein and antibody engineering, expression and production. "We have developed a platform whereby we can deliver antibody quickly without the need of immunization," says Ms Supriya, a Biologist. Its research focus is in developing antibody for research, diagnostics and therapeutics. With this goal, GNG has developed a therapeutic candidate molecule for MTB (Mycobacterium Tuberculosis), and TNF (Tumor Necrosis Factor) alpha. She adds that the main focus is to reduce the cost of antibody resources, and maintaining its specificity and consistency. Comments Ms Supriya, "Our idea of starting a new company was to deliver cost-effective scientific resources to the Indian scientific fraternity. Our constant effort is to use our intellect to identify the bottleneck areas in Life Sciences, and develop technologies right here in our own country and help the society." "Our platform will deliver the smallest antibody with high specificity in a lesser time frame," she points. The start-up has a strong team of 9 scientists with extensive experience in proteins, molecular biology and immunology, headed by a very experienced Structural Biologist, Dr Vinod Agarkar. She says that Mr Ravi Kashikar, the chairman of Ankur Seeds, influenced her to step into the entrepreneurial journey. Analyzing a niche area, the team found that there is huge need for TB research for new drug development. "We worked along with Prof Harinath in MGIMS (Mahatma Gandhi Institute of Medical Sciences), who has given his whole life researching TB, and identified a novel target. Our company is developing a lead molecule against the target, and consequently a new biological entity as a therapeutic," Ms Supriya states. Painful Policies So far the journey has been tough for the founders. Finding the right kind of facility for GNG's work was very hard as there were no incubators around Nagpur. "We had to collaborate with several labs in and outside the country to facilitate our research. The Government should bring in more incubators to other towns to foster more innovation. Right from inception, we have faced very tough system in the Indian Government's policies for companies that are research-based," opines Ms Supriya. "For high-quality research," she continues, "we need quality capital assets, and analytical instruments which incurs huge cost and requires to be imported from abroad. There are so many rules for custom clearance and the cost incurred is huge. The Government does give accreditation/DSIR when there are sales returns. This gives benefits for the R&D, but for start-ups with no initial ROIs, they have to face tough times." Finding the right manpower has also been a great challenge. "Being in B-Town, there was difficulties in getting skilled people with analytical minds," she adds. High-Risk Investments Initially, the founders invested their own hard-earned money into GNG. Later the start-up was selected for BIG (Biotechnology Ignition Grant) from the Department of Biotechnology (DBT) and Biotechnology Industry Research Assistance Council (BIRAC), which boosted its innovations further. "The BIG-BIRAC has been a very nice initiative taken by DBT for biotech start-ups. From the proof-of-concept (PoC) to the product, biotech industry involves huge-risk. Investor in India are still scary to fund high-risk projects. But BIG has given a lot of boost and credibility to innovations in India. To date, many of the start-ups are benefitted and lot many await," she explains. She points that in the West, investors are ready to fund high-risk ideas. "In India, most of the VCs want to see instant returns which does not work with high-risk and high-benefit ideas. Academic support to start-ups and spin-offs are best in the West. They work more in collaboration, which yields good innovation and translational product. In India, right at the conceptualization stage, we need to clearly explain to investors that it is a highrisk investment with long gestation periods," she states. "To add to this, I must say people always want grey hair and look for degrees behind your name when you are presenting the business idea to a funding agency. But only passion and will power will enable success. This is our personal experience," she notes. About Rs 20 million worth investments have gone into GNG. The company has bagged Indo-French project from Indo-French Center for the Promotion of Advanced Research (CEFIPRA), along with The Center for Bioseparation Technology (CBST) at Vellore Institute of Technology (VIT), thereby boosting its credibility. Big Pharmas Right now, the start-up has designed MTB candidates which are in lead characterization stage. "We would want to work with bigger pharma companies who can take this molecule to the next stage to develop a therapeutic solution for TB, which is a major killer in developing countries. We have also developed a platform to deliver smaller antibody with high specificity which can be cost-effective, and it caters to huge client list such as pharma, biotech and agriculture industry," expresses Ms Supriya. GNG now has the capability to deliver engineered smaller antibody working against any targets. Its collaborations at the moment is with Jamnalal Bajaj Tropical Disease Research Centre (JBTDRC), at MGIMS and CBST, at VIT. Generics To Innovation Ms Supriya says that initially Indian companies were more inclined towards generics which was need of the hour. "But now," she observes, "the trend is changing towards innovation and need-based solutions. Start-ups like us and many others have innovative ideas and bring it to PoC stage which is taken up by companies. Such trend has started, and in the coming days this will grow." She feels that there is a lot of scope for Indian start-ups for antibody reagent and assay development for diagnostics and research. "This will be an effort which can even be taken up by the 'Make in India' initiative. As said by Dr Kiran Mazumdar in one of her inter-views, innovation does not just mean making new things but also making older things in an innovative way to reduce costs," she mentions. Ms Surpriya's loves reading, traveling, blogging, and draws her inspiration from Biocon's CMD Dr Kiran Mazumdar herself. Entrepreneurial Lessons Learnt: ï‚§ Right Teamï‚§ Right Finance Management ï‚§ Right strategy Dealing With Start-up Stress: ï‚§ Focus and focusing rightï‚§ Surrounding with good mentors and encouragersï‚§ Embracing family support Elements For Starting Up: ï‚§ Good idea with practical approachï‚§ Exceptional team ï‚§ Strategic planning ï‚§ Pitching in fast at the right time Essential Entrepreneurial Qualities: ï‚§ Consistencyï‚§ Patienceï‚§ Taking risksï‚§ Being technically soundï‚§ Understanding start-ups' financial dynamics ]]> <![CDATA[Lupin launches Generic Ortho Tri-Cyclen Lo Tablets]]> https://biospectrumindia.com/news/95/7133/lupin-launches-generic-ortho-tri-cyclen-lo-tablets.html https://biospectrumindia.com/news/95/7133/lupin-launches-generic-ortho-tri-cyclen-lo-tablets.html Thu, 07 Jan 2016 10:54:29 +0530 Pharma Major Lupin has announced that its US subsidiary Lupin Pharmaceutical Inc. has launched its Tri-Lo-Marzia Tablets (Norgestimate and Ethinyl Estradiol Tablets USP, 0.180 mg/0.025 mg, 0.215 mg/0.025 mg, and 0.250 mg/0.025 mg) having received approval from the United States Food and Drug Administration (FDA). Lupin's Tri-Lo-Marzia Tablets (Norgestimate and Ethinyl Estradiol Tablets USP, 0.180 mg/0.025 mg, 0.215 mg/0.025 mg, and 0.250 mg/0.025 mg) are the AB rated generic equivalent of Janssen Pharmaceutical's Ortho Tri-Cyclen Lo Tablets, (Norgestimate and Ethinyl Estradiol Tablets USP, 0.180 mg/0.025 mg, 0.215 mg/0.025 mg, and 0.250 mg/0.025 mg). It is indicated for use by women to prevent pregnancy. Ortho Tri-Cyclen Lo Tablets had US sales of $488.4 million (IMS MAT September 2015). ]]> <![CDATA[Cipla, BioQ Pharma partner for Ropivacaine infusion system]]> https://biospectrumindia.com/news/95/3935/cipla-bioq-pharma-partner-for-ropivacaine-infusion-system.html https://biospectrumindia.com/news/95/3935/cipla-bioq-pharma-partner-for-ropivacaine-infusion-system.html Thu, 07 Jan 2016 10:54:00 +0530 BioQ Pharma Incorporated, a specialty pharmaceutical company focused on the development and commercialization of single-use, large-volume ready-to-use infusible pharmaceuticals, and Cipla has announced the signing of a strategic distribution, supply and development agreement for the registration and commercialization of BioQ Pharma's Ropivacaine infusion pharmaceutical in India. BioQ Pharma's unit-dose infusion pharmaceuticals have been developed as ready-to-use presentations in which the drugs and administration systems are self-contained and delivered at the point of care. In particular, the Ropivacaine infusion system is pre-filled, ready to use at the point of care, and intended to provide a safer, more efficient continuous-infusion post-operative pain solution. Mr Josh Kriesel, president and CEO of BioQ Pharma, said, "We are excited to collaborate with Cipla as we expand our worldwide commercial footprint into India. We believe India is an excellent market to help expand our objective of establishing a new standard of care in the presentation and administration of infusible pharmaceuticals. Cipla's proven, hospital-focused sales and marketing organization will be essential in introducing BioQ Pharma's proprietary unit-dose, large volume infusion pharmaceuticals to India's healthcare market, which we believe will benefit from our product's value-add proposition of increased safety, sterility and convenience." Mr Nikhil Chopra, head of Cipla's India Business, added, "We are very pleased to partner with BioQ Pharma in introducing the Ropivacaine unit-dose infusion system to patients and caregivers in India. We believe that this innovative product represents a significant evolution in enhancing the delivery of infusions and managing post-surgical pain." ]]> <![CDATA[Glenmark USA receives tentative ANDA approval for Dronedarone]]> https://biospectrumindia.com/news/95/6875/glenmark-usa-receives-tentative-anda-approval-for-dronedarone.html https://biospectrumindia.com/news/95/6875/glenmark-usa-receives-tentative-anda-approval-for-dronedarone.html Wed, 06 Jan 2016 13:32:09 +0530 'Tentative approval' means that FDA has concluded that a drug product has met all required quality, safety and efficacy standards, but is not eligible for marketing in the US because of existing patent protections or exclusivities. Glenmark believes it is one of the first companies to have filed a substantially complete ANDA containing a Paragraph IV certification for Dronedarone Tablets and expects to be eligible for 180 days of generic drug exclusivity upon final FDA approval. Glenmark remains involved in a patent litigation in the US District Court for the District of Delaware, wherein Sanofi and Sanofi-Aventis US has asserted its patents. According to IMS Health sales data for the 12 month period ending November 2015, the Multaq market achieved annual sales of approximately $425.7 million. Glenmark's current portfolio consists of 104 products authorized for distribution in the US marketplace and 62 ANDA's pending approval with the USFDA. In addition to these internal filings, Glenmark continues to identify and explore external development partnerships to supplement and accelerate the growth of its existing pipeline and portfolio. ]]> <![CDATA[Zydus expands animal health business with a strategic acquisition]]> https://biospectrumindia.com/news/95/7460/zydus-expands-animal-health-business-with-a-strategic-acquisition.html https://biospectrumindia.com/news/95/7460/zydus-expands-animal-health-business-with-a-strategic-acquisition.html Wed, 06 Jan 2016 11:04:40 +0530 Zydus Group which is a leading player in the animal health business through its division Zydus Animal Health has announced the strategic acquisition of select brands and the manufacturing operations in Haridwar, India, of Zoetis a global animal health company. The acquisition will help Zydus expand its animal health business in India and gain access to manufacturing operations which have also been catering to global markets. The financial details of the deal remain undisclosed. As a result of this acquisition, Zydus gains access to a wide range of nutrition as well as therapeutic products which have strong brand equity and a combined turnover of Rs. 171 Cr. A major boost to Zydusâ€Ÿ portfolio would be the addition of livestock farm care products which are well accepted in the market. Zydusâ€Ÿ access to the WHO GMP approved manufacturing facility is expected to boost its exports and institutional business. The plant spread over 10,000 sq. meters manufactures Tablets, Liquid Orals and Injectables. Speaking on the development, chairman and managing director, Zydus Cadila, Mr Pankaj R Patel said, "We believe that this strategic acquisition will strengthen our portfolio of brands and add new dimensions to our growth in the animal health business. We see this as an opportunity to catapult our business to higher levels of excellence." ]]> <![CDATA[Global immunology treatment market will exceed $74 bn by 2022]]> https://biospectrumindia.com/features/95/4063/global-immunology-treatment-market-will-exceed-74-bn-by-2022.html https://biospectrumindia.com/features/95/4063/global-immunology-treatment-market-will-exceed-74-bn-by-2022.html Tue, 05 Jan 2016 17:48:01 +0530 According to the company's latest report, the immunology treatment market's Compound Annual Growth Rate (CAGR) will equal a relatively stable 2.71%, due to practical and regulatory barriers to entry for biosimilars that are not present for small molecule generics, and a moderately strong late-stage pipeline. Mr Dominic Trewartha, Managing Analyst for GBI Research, says: "This market is a lucrative area as up to 7% of western populations are thought to be affected by chronic immunological disorders. Consequently, the pharmaceutical pipeline for immunology is considerable, with 1,896 products currently in active development. "While 85 of these are in Phase III of the process, it must be acknowledged that 73% of these pipeline products are in early developmental stages." GBI Research's study suggests there are a number of prospective products expected to achieve strong annual revenues during the forecast period, although these are not anticipated to achieve revenues comparable to those generated by the current strongest-selling immunology products. Mr Trewartha explains: "To date, the most clinically and commercially effective drugs have been in a class of compounds known as monoclonal Antibodies (mAbs), which includes blockbuster products such as Humira (adalimumab) and Remicade (infliximab). "APB-501, a biosimilar of Humira, which was the best-selling drug of 2014 worldwide, is anticipated to generate annual revenues of almost $1 billion by 2022, making it an exceptionally strong-performing non-patented drug." The analyst adds that while the immunology therapeutics market is a very commercially active area, with a number of exceptionally high-selling products present, revenues for these key drugs are expected to undergo a steady decline towards the end of the period. Mr Trewartha concludes: "GBI Research believes that revenues for immunology therapeutics will only significantly decline in the long term, beyond the forecast period. This is due to the protective effect of the practical and regulatory challenges in fielding biosimilar products, which reduces the impact of patent expiries on biologics, compared with small molecules." ]]> <![CDATA[Baxalta inks immuno-oncology pact with Symphogen ]]> https://biospectrumindia.com/news/95/4074/baxalta-inks-immuno-oncology-pact-with-symphogen-.html https://biospectrumindia.com/news/95/4074/baxalta-inks-immuno-oncology-pact-with-symphogen-.html Tue, 05 Jan 2016 14:59:24 +0530 Baxalta and Symphogen has announced a broad strategic immuno-oncology collaboration. Under the terms of the agreement, Baxalta and Symphogen will advance novel therapeutics against six checkpoint targets, with the first program to enter clinical studies in 2017. On a product-by-product basis, following successful completion of Phase 1 clinical trials, Baxalta will have exclusive option rights to complete late-stage development and worldwide commercialization. Symphogen will receive an upfront payment of $175 million (â‚¬160 million) from Baxalta in exchange for the exclusive option rights for six checkpoint therapies. Symphogen will be responsible for performing R&D through Phase 1 clinical trials at its own expense. The agreement holds a total potential value up to â‚¬1.4 billion ($1.6 billion) in option fees and milestones over the long-term, in addition to royalties on worldwide sales. Additional terms, including therapeutic targets, were not disclosed. "This exciting partnership aligns well to Baxalta's strategy to invest in immuno-oncology and build an innovative portfolio of immunotherapies," said Mr David Meek, executive vice president and president, Oncology, Baxalta. He added, "With the expertise Symphogen offers in this category and their broad portfolio of early-stage immuno-oncology programs, this collaboration allows us to actively advance one of the most innovative areas of this field. For Baxalta, this is just the beginning of our focus in building world-class capabilities in immuno-oncology." "Baxalta's dedication to delivering transformative therapies and its global commercial presence make it an ideal strategic partner for Symphogen, as we complement Baxalta with R&D competencies within the immuno-oncology area," said Dr Kirsten Drejer, chief executive officer, Symphogen. "We look forward to providing Baxalta with innovative immuno-oncology product candidates under this broad collaboration." ]]> <![CDATA[AZ' gout therapy gets FDA approval ]]> https://biospectrumindia.com/news/95/5455/az-gout-therapy-gets-fda-approval-.html https://biospectrumindia.com/news/95/5455/az-gout-therapy-gets-fda-approval-.html Tue, 05 Jan 2016 11:54:06 +0530 AstraZeneca announced that the US Food and Drug Administration (US FDA) has approved ZURAMPIC (lesinurad) 200mg tablets in combination with a xanthine oxidase inhibitor (XOI) for the treatment of hyperuricemia associated with gout in patients who have not achieved target serum uric acid (sUA) levels with an XOI alone. ZURAMPIC inhibits the urate transporter, URAT1, which is responsible for the majority of the renal reabsorption of uric acid. By inhibiting URAT1, ZURAMPIC increases uric acid excretion and thereby lowers sUA. In combination with the current standard of care, XOIs allopurinol or febuxostat, ZURAMPIC provides a dual mechanism of action to increase excretion and decrease production of uric acid, enabling more patients with inadequately controlled gout to achieve target treatment goals. Mr Sean Bohen, executive vice president of Global Medicines Development and Chief Medical Officer, AstraZeneca, said, "With the FDA approval of ZURAMPIC, we are pleased to offer a new treatment option for the many patients who are suffering from the effects of gout and who are not reaching the recommended serum uric acid treatment targets with the current standard of care." The FDA approval is based on data from three pivotal Phase III studies, CLEAR1, CLEAR2 and CRYSTAL, which represent the largest clinical trial data set of gout patients (n=1,537 total) treated with combination urate lowering therapy. Gout is a serious and debilitating form of inflammatory arthritis caused by hyperuricemia (elevated sUA). It affects millions of people around the globe, many of whom do not reach recommended sUA treatment goals on XOIs, which decrease production of uric acid. For those inadequately controlled patients, the addition of a urate-lowering therapy to increase excretion of uric acid may help them achieve treatment goals. ZURAMPIC is also under regulatory review in the European Union and other territories. ]]> <![CDATA[â€œAnna University's NHHID enables indigenous instrument manufacture for highly affordable healthcare"]]> https://biospectrumindia.com/interviews/95/8475/anna-universitys-nhhid-enables-indigenous-instrument-manufacture-for-highly-affordable-healthcare.html https://biospectrumindia.com/interviews/95/8475/anna-universitys-nhhid-enables-indigenous-instrument-manufacture-for-highly-affordable-healthcare.html Mon, 04 Jan 2016 13:29:00 +0530 To begin with, can you outline the nature of NHHID for our readers? Undue dependence (85%) on imports costs us dearly. Therefore quick augmentation of our ability to develop instruments of global standards right at University level is imperative. This led to NHHID as a viable approach to sustainable solution for affordability of quality healthcare. NHHID is a novel facilitation concept and structure conceived by Department of Science and Technology under the auspices of Technology Development and Transfer Division and implemented by Anna University by integrating Scientists, Engineers, Technologists, Clinicians, Industrialists and Businessmen to accelerate indigenous healthcare instrumentation. It is formed by bringing together six different engineering/ technology groups of Anna University (Electronics & Communication Engineering, Centre for Biotechnology, Manufacturing Engineering, Electronics Engineering and groups with similar and complementary expertise from six other reputed institutions such as Indian Institute of Science, Madras Veterinary College, Christian Medical College, CSIO, IIT(M) and Central Electro Chemical Research Institute to begin with. It translates and transfers commercially viable healthcare innovations from these academic departments and research institutions to companies. It's major roles: serves as R&D arm of small and medium enterprises and hospitals; bridges the gap between prototype development and its commercialization after multi-centric validation through its product realization facility; runs testing and calibration facility for medical devices; trains manpower and educates medical and engineering professionals in the areas of biomedical engineering and instrumentation; aids apex bodies like DST, NHSRC and BIRAC to identify commercially-viable ideas and projects on healthcare devices and provide necessary support. In brief, using a multipronged approach, NHHID enables indigenous instrument manufacture for highly affordable healthcare. What are the major instruments and equipment designed by the institute and how have these instruments made a mark in the medical field? Antibiogram device: An inexpensive fluorescence imaging device for quicker (6-8hrs) antibiotic selection for effective treatment, particularly Urinary Tract Infection. Leptospirosis kit: IgM-based ELISA test kit replaces the cumbersome MAT-microscopic agglutination test cutting the cost by a fifth of the present. Chikungunya Kit: Isothermal amplification of viral RNA with non-gel based instrumental detection affordable and amenable for primary healthcare. CMCdaq: CMCdaq is a hand-held, versatile recording system designed for long-duration electrophysiological data acquisition suitable for human recording. Sophisticated electronics ensures high quality recording. Mass screening gadget for ophthalmic lesions: An automated system to aid ophthalmologists in the analysis of Fundus images for the diagnosis of glaucoma and diabetic retinopathy. Hystero electrical activity mapping device: It acquires and processes uterine contractile potential, Electro Hystero Gram (EHG), and foetal ECG (FECG) non-invasively to warn obstetricians of foetal distress condition as labour progresses and help decide the right course of action. Synthetic milk tester: This is a simple 'dip-and-read' reagent-free electrochemical device to detect synthetic milk adulteration, a major problem faced by the country without proper tool. Milk protein estimator: A 3-digit portable colorimetric gadget and proprietary method specifically developed for measuring raw milk protein, accurately by the collection centres for paying according to quality and food labs. The technologies of Leptospirosis kit and CMCdaq have been transferred to respective manufacturers for multi-centric validation and manufacture. The rest of the instruments are in various stages of technology transfer for commercialization. How are the Department of Science and Technology and Anna University supporting the Institute (in terms of funding and technology support)? The idea of a structure like Hub facilitating instrumentation development originated in the Technology Development and Transfer (TDT) division of DST way back in 2006. It is a matured idea based on collective wisdom of the Advisors of the TDT Division, Chairmen of various Instrumentation Committees of Instrumentation Development Program (IDP) and from decades of experience in supporting a number of instrumentation projects covering diverse areas of industrial, commercial and social importance and need-of-the-country. Their constant experimentation with strategies to convert project outputs into tangible products led to the realization that a dedicated infrastructure like NHHID was necessary to bridge commercial and academic worlds. Consequently, after thorough evaluation of Anna University's proposed model by three different Expert Advisory Committees of IDP for two years, DST sanctioned Rs. 12.4 Cr in 2011 for five years to set-up this national facility. Highly diversified engineering and technology disciplines (more than hundred) including proven competence in instrumentation development and track record in commercialization worked favorably. Working closely, DST constantly monitors and guides Hub development through half-yearly review by a 15-member Steering Committee consisting of complementary mix of renowned scientists heading mega national/international projects, highly respected academics, successful business leaders, policy makers and regulators from across the country. Anna University and DST worked hard for two years in carefully designing and shaping the National Hub. Multidisciplinary research environment and ecosystem established in the last 15 years through pioneering and novel programs like Centre with Potential for Excellence by UGC, availability of critical support infrastructure for IPR filing and technology transfer, intellectual management with long-term vision of the Vice Chancellors with matching administrative flexibility guided by Registrars, who themselves are academic researchers, all contribute to the success of this bold initiative. The RD&C (where C is for commercialization) policy of the present Vice Chancellor, Prof. M Rajaram, Ph.D. has been the driving force behind the rapid advancements of the Hub in the last two years. As a result, NHHID is able to help even partner institutions to file their patents, develop products and technology-transfer them to companies. In this 5-year (2010-2015) period, what are the significant advances in medical instrumentation and how has the institute been part of this progress? The major advances in medical instrumentation in this period are: miniaturization and automation for high-throughput multi-parameter analysis of biochemicals and molecular markers; improvements in imaging hardware and software for better physician aids in diagnosis; sensor-based instrumentation on mobile platform for point-of-care patient aids and telemedicine, additive manufacturing of customized prosthesis and robotics-assisted precision surgery. Keeping these developments and our own ground realities in mind, NHHID is progressing towards developing highly affordable devices for prevalent diseases of our land. Could you name the regional collaborations that the institute has signed and how have these collaborations yielded results? NHHID thrives on collaborations, both regional and national. Regionally we collaborate with institutes, industries, hospitals, and stakeholder associations/bodies. Most significantly, exclusive MoU with Directorate of Medical Education (DME) based on Govt. of Tamilnadu GO {GO(D) 201} enables joint product development, training, awareness of testing and calibration of medical devices etc. Commercialization of products from regional partner institutions, Joint Development Agreement with industries, establishment of crucial facilities like product realization, joint outreach programmes in biomedical engineering etc are other significant outcome. Are there any medical conditions that lack proper instrumentation? What measures is the Institute adopting to design such equipment? Instrumentation for Infectious diseases remains neglected despite the medical and economic burden of these diseases. Classical microbiological methods, which are low-throughput, laborious and less affordable, are quite inadequate and ineffective. Consequently "Multi Drug Resistance" is a major problem and a grave concern. In contrast, even serious non-infectious diseases like diabetes and heart attack are diligently and effectively managed using modern instrumentation. Ironically, for the past two decades, molecular-level details about most of the infectious diseases are known to enable new instrumentation methods and instruments. NHHID has developed an inexpensive instrumentation solution to enable doctors to prescribe the right antibiotic within 6-8hrs or second dose of an antibiotic. This could be a game changer in antibiotic therapy and compliance for a test before therapy. Initially we are targeting Urinary Tract Infections, prevalent among female population and diabetic patients and notorious for MDR and spread in communities. Leptospirosis kit and method for Chikungunya detection are based on innovation using modern knowledge. Customized prosthesis for Indian population based on emerging additive manufacturing or 3D printing of skeletal parts or exoskeleton is a boon. Preparing the best-fitting 3D model from 2D radiological images demands innovative image processing and modeling and we specialize on this along with surgeons and industrial partner. Medical devices, particularly life-saving medical devices like vital sign monitors and ventilators, require periodic testing and calibration for absolute reliability. Paucity of facilities offering such services and lack of policy for making such procedures mandatory are addressed by DST through NHHID. We are establishing a NABL-accredited testing and calibration centre for this purpose and creating awareness among doctors, biomedical engineers and even patients. We'll develop calibration procedures for new indigenous instruments. This generation is witnessing the spin-off of startup entrepreneurs. Has the institute supported any such startup? The mandate of NHHID is to promote and support indigenous healthcare instrumentation developers including startup entrepreneurs. We are transferring technology mainly to small and medium enterprises with limited research, manufacturing and testing capabilities. We are looking at entrepreneurship development out of institutions, which can provide adequate intellectual and infrastructure support for product realization and commercialization. In this regard Biotechnology Industry Research Assistance Council offers excellent schemes. Alumni support of public academic institutions and management support of private academic institutions are also viable options. What are the future plans for the institute (2015-2020)? Having initiated well and learned valuable lessons, we'll remain focused on strengthening the leads like clinician/industry-driven projects and rare facilities like the Product Realization Center, Business Liaison and Promotion Division and Testing and Calibration Center to accelerate and sustain indigenous healthcare instrumentation development. We'll network with major stakeholders and their apex bodies like DST, BIRAC, DHR, National Health Systems Resource Centre (NHSRC), NABL, Association of Indian Medical Devices (AIMED), Indian Medical Association (IMA), CII, FICCI, TANSTIA, Madras Chamber of Commerce (MCC) and All India Management Association (AIMA) to synergize and bring the manufacturers, users, govt. agencies and academics under one umbrella for quick decisions and road map to market Indian healthcare devices and accessories. Already a forum called UDAIMED with NHHID playing the key role of integrating academics with users, developers and industries has been formed. To aid funding organizations, health ministry's technical wing, NHSRC, and even medical device manufacturers, who are looking for IPR-protected innovative ideas or prototypes, NHHID will build healthcare instrumentation informatics and mine for relevant details for timely support and RD&C. We'll aid establishing testing, calibration and certifying facility, as in NHHID, pan-India to ensure accessibility to uniform quality and make such requirement essential for accreditation. Awareness about and training on biomedical instrumentation is vital for the engineering- and technology-driven medical profession, manufacturing and marketing. It will be actively pursued through a number of outreach programmes including certification courses. Internal Revenue Generation (IRG) to become self supporting is a prime motive of NHHID. Such models can then be replicated in other parts of India to build a robust Indian healthcare instrumentation capability to increase our presence in our own country and provide more affordable healthcare for public. In essence NHHID should become an asset in the country's healthcare infrastructure fostered by Anna University. Anusha Ashwin ]]> <![CDATA[Despite unmet needs, systemic sclerosis treatment market to hit $500 mn by 2024]]> https://biospectrumindia.com/features/95/7985/despite-unmet-needs-systemic-sclerosis-treatment-market-to-hit-500-mn-by-2024.html https://biospectrumindia.com/features/95/7985/despite-unmet-needs-systemic-sclerosis-treatment-market-to-hit-500-mn-by-2024.html Mon, 04 Jan 2016 13:13:28 +0530 The systemic sclerosis treatment market will expand from just under $316 million in 2014 to approximately $500 million by 2024, representing a modest Compound Annual Growth Rate (CAGR) of 4.7%, says research and consulting firm GlobalData. Systemic sclerosis pathophysiology is complex and incompletely understood. Treatment varies by patient and aims to address complications, but no single therapy targets the underlying disease mechanism. According to the company's latest report, this rise, spread across the seven major markets of the US, Italy, France, the UK, Spain, Germany, and Japan, will be driven by a number of factors, including an increased use of expensive biologics, and off-label use of therapies to treat the disease. As such, Dr Heather Leach, GlobalData's Managing Analyst covering Immunology, states that while the systemic sclerosis treatment market will see some growth by 2024, unmet needs will not be completely addressed. Dr Leach explains: "Currently, patient needs are not being met due to a lack of anti-fibrotic drugs and disease-modifying therapies, delays in diagnosis, and a lack of safe and effective treatments. "Ideally, rheumatologists would like one therapy that is able to address all disease manifestations, and would target, or even reverse, fibrosis. However, due to the rarity of the disease and the difficulty in treating it, there has been a lack of overall interest in the market." Despite this, there has been renewed interest from pharmaceutical companies, and the pipeline will see some interesting developments over the forecast period. Dr Leach continues: "The development of biologics for use in systemic sclerosis, specifically Roche/Genentech's Actemra (tocilizumab) and Bristol-Myers Squibb's Orencia (abatacept), will offer improvements over the current standard of care. "Although these drugs will likely offer some relief for patient with fibrosis and arthritis associated with systemic sclerosis, they are unlikely to reverse fibrosis, and the evidence for their treatment of digital vasculopathy and pulmonary arterial hypertension is limited at this point." ]]> <![CDATA[Top pharma cos' R&D returns continue to slide: Deloitte]]> https://biospectrumindia.com/features/95/4064/top-pharma-cos-rd-returns-continue-to-slide-deloitte.html https://biospectrumindia.com/features/95/4064/top-pharma-cos-rd-returns-continue-to-slide-deloitte.html Mon, 04 Jan 2016 13:03:51 +0530 While the Research and Development (R&D) divisions of 12 leading pharmaceutical companies have progressed 306 assets into late-stage pipelines since 2010, with projected lifetime returns of over $1.41 trillion, these returns are continuing to decline in percentage terms, according to a study produced by Deloitte in collaboration with research and consulting firm GlobalData. This study, published by the Deloitte Centre for Health Solutions, states that the original cohort has launched 186 products since 2010, with a projected lifetime value of just under $1.26 trillion. However, the collective R&D returns for this cohort have declined markedly, from 10.1% in 2010 to just 4.2% in 2015, while the average cost of asset development has risen by a third. The study focuses on a longer-term view of R&D returns, as this reduces the volatility of static measures, which can be skewed by particularly high or low revenue expectations. As assets can take approximately 15 years to progress from discovery to launch, and revenue forecasts can change substantially as they progress through late-stage development, a longer-term view provides a more robust analysis of an organization's likely R&D returns. This year, the group of companies analyzed has been extended to include four mid- to large-cap companies, so that greater insight can be derived from the R&D returns analyses, particularly around identifying company characteristics that lead to high performance. Mr Jim Coutcher, GlobalData's Global Head of Healthcare, says that across the 16 companies included in the report, there has been an increasing focus on specialized therapeutics. He comments: "The pharmaceutical industry's R&D focus has been shifting towards specialty therapy areas, given the high levels of patient unmet need and the identification of discrete patient populations. "However, the study in collaboration with Deloitte shows an increased degree of specialization within primary care therapy areas, as companies are looking to new types of therapies, mechanisms of action and patient segments as untapped opportunities to deliver value." Dr Sean Hu, GlobalData's Vice President & Head of Consulting in the US for Pharmaceutical and Diagnostics Industries, and the senior leader of the GlobalData team responsible for this joint study with Deloitte, adds: "This annual report is the second of a multi-year series to be produced by the collaborative effort of Deloitte and GlobalData. "The successful delivery of this report required extensive analysis of a high volume of data, and leveraged GlobalData's industry-leading proprietary databases and drug-related analytical capabilities. "This study not only depicts industry level trends among leading pharma and biotech companies in terms of R&D productivity, but also sheds light on differences across those companies and points to potential directions for R&D productivity enhancement." ]]> <![CDATA[Orchid Pharma gets EIR report from FDA ]]> https://biospectrumindia.com/news/95/7984/orchid-pharma-gets-eir-report-from-fda-.html https://biospectrumindia.com/news/95/7984/orchid-pharma-gets-eir-report-from-fda-.html Mon, 04 Jan 2016 11:52:44 +0530 Orchid Pharma has informed BSE that it has received the Establishment Inspection Report (EIR) from United States Food and Drug Administration (USFDA) based on the successful inspection closure for the formulation manufacturing facility located at Irungattukottai, Sriperumbudur, Kancheepuram District, India. The facility was inspected by US health regulator in the month of May 2015. Orchid Pharma is present in segments such as anti-infectives, anti-inflammatory, central nervous system, cardio vascular, nutraceuticals and oral as well as sterile products. ]]> <![CDATA[Novartis completes animal health business sale transaction]]> https://biospectrumindia.com/news/95/6348/novartis-completes-animal-health-business-sale-transaction.html https://biospectrumindia.com/news/95/6348/novartis-completes-animal-health-business-sale-transaction.html Fri, 01 Jan 2016 15:11:08 +0530 Novartis India has completed the transaction to sell its animal health business to Elanco India, an affiliate of Eli Lilly. In a filing to BSE, the company said, "Following the approval from the Foreign Investment Promotion Board ( FIPB), Indian government and Competition Commission of India, we wish to inform you that the transaction for the transfer of the company's animal health division to Elanco India has been completed." In April 2014, Novartis had agreed to sell its global animal health business to Eli Lilly and Co for about $5.4 billion in an all-cash transaction. ]]> <![CDATA['India's pharma industry to touch $55 billion' ]]> https://biospectrumindia.com/news/95/7475/indias-pharma-industry-to-touch-55-billion-.html https://biospectrumindia.com/news/95/7475/indias-pharma-industry-to-touch-55-billion-.html Fri, 01 Jan 2016 12:04:36 +0530 A joint report by Assocham and TechSci Research reveals that the Indian pharmaceutical industry is expected to touch $55 billion by 2020 as against the current size of $18 billion but the exports may slow down to grow at a CAGR (Compounded Annual Growth Rate) of 7.98 percent in value terms due to tightening of regulatory mechanism in top exports markets of US, Russia and Africa. As per the report, "Consolidation of pharmacy players is leading to an increase in pricing pressures for generic companies existing in the US market, which is expected to result in a decline in the year-on-year growth of pharmaceutical exports from India over the next five years. A steep decline in currency in emerging markets such Africa, Russia, Ukraine and Venezuela may add to woes of drug manufacturers that supply pharmaceutical drugs to that region and are unable to generate high revenues on account of selling their drugs at a low priced currency. India is the largest supplier of medicine to the US and pharmaceutical exports from India rose from $3.44 billion in 2013 to $3.76 billion in 2014. "Pharmaceutical exports to the US are rising due to the increasing demand for high quality generic drugs in the market. However, the growth rate for exports of pharmaceutical products from India to the US is declining, due to increasing US Food and Drug Administration (FDA) scrutiny on the quality of pharma products coming from drug from drug manufacturing plants located in India. In order to boost the growth rate of exports to the US, Indian companies will need to leverage their compliance to US FDA regulations," the report added. ]]> <![CDATA[FDA issues warning letter to Cadila ]]> https://biospectrumindia.com/news/95/6742/fda-issues-warning-letter-to-cadila-.html https://biospectrumindia.com/news/95/6742/fda-issues-warning-letter-to-cadila-.html Fri, 01 Jan 2016 12:03:52 +0530 Cadila Healthcare has received a warning letter from the United States Food and Drug Administration (US FDA) relating to its Moraiya formulation facility and Ahmedabad API facility (Zyfine). Cadila said that it takes quality and compliance matters very seriously and stand by its commitment to fully comply with cGMP quality standards across all its facilities. "The company is working hard to ensure that the commitments made to the US FDA are fully completed. The company will continue to take all necessary steps to ensure that the US FDA is fully satisfied with our remediation of the above facilities. Our products in the market are safe and effective and we are committed to supply the quality products to our customers across the globe," said Cadila in a statement. "We hereby clarify that there are no products in the US market which use API of Zyfine facility. We will respond to the FDA to address the observations within the statutory time permitted in the letter. We are committed to resolve all the issues and revamp our quality systems and processes as the top most priority," said Cadila in a statement," the company added. ]]> <![CDATA[Mission $100 billion by 2025: National Biotechnology Development Strategy 2015-2020 unveiled]]> https://biospectrumindia.com/news/95/8369/mission-100-billion-by-2025-national-biotechnology-development-strategy-2015-2020-unveiled.html https://biospectrumindia.com/news/95/8369/mission-100-billion-by-2025-national-biotechnology-development-strategy-2015-2020-unveiled.html Wed, 30 Dec 2015 16:42:45 +0530 The National Biotechnology Development Strategy 2015-20 was unveiled on December 30, 2015 by the minister for science and technology and Earth Sciences, Dr Harsh Vardhan in the presence of the secretary, Department of Biotechnology, Dr VijayRaghavan and other key stakeholders. The Strategy aims to establish India as a world-class bio-manufacturing hub. It intends to launch a major mission, backed with significant investments, for the creation of new biotech products, create a strong infrastructure for R&D and commercialization, and empower India's human resources scientifically and technologically. While addressing the media persons, Dr Harsh Vardhan mentioned, "The DBT is going to soon complete 30 years. It has done commendable work over the years in catalyzing the growth of the biotechnology industry, which has a huge potential to positively impact the lives of Indians in every area, such as research, education, health, technology, and energy. This was sensed a long time ago by the Government. When Mr Atal Bihari Vajpayee was the prime ministry, he used to say that while IT (information technology) stands for 'India Today,' BT (biotechnology) stands for 'Bharat Tomorrow.'" The minister added further: "I believe this industry has the potential to grow like the IT industry over the next ten years and beyond. The development of the inexpensive rotavirus vaccine, available for less than a dollar in India when internationally it costs 50 dollars, is an example of what can be achieved by the Indian biotechnology industry. Several other vaccines, such as for dengue and malaria, are already under development. The growth prospects of the Indian biotechnology industry are bright provided it receives the right stimulus and an enabling environment." The secretary, DBT, Dr VijayRaghavan in his talk elaborated on the status of the sector. "Biotechnology has an important part to play in India's growth story and there is enthusiastic support from the Government for this vision. We have drafted a very ambitious strategy with the target to turn biotechnology into a US $100bn industry by 2025. I believe this is not impossible to achieve. Several growth opportunity exists. For example, many low-end products can be successfully manufactured in India. Our challenge is to stimulate the industry players to make them partner internationally in developing these products at the fraction of the cost of what is possible outside India, and the sell them nationally as well as globally. A huge opportunity exists in the manufacture of diagnostic kits too," said Dr Raghavan. The key elements of the National Biotechnology Development Strategy 2015-20: â€¢ Build skilled workforce and leadershipâ€¢ Revitalize the knowledge environment at par with the growing bio-economyâ€¢ Enhance research opportunities in basic, disciplinary and inter-disciplinary sciencesâ€¢ Encourage use-inspired discovery researchâ€¢ A focus on biotechnology tools for inclusive developmentâ€¢ Nurture innovation, translational capacity and entrepreneurshipâ€¢ Ensure a transparent, efficient and globally best regulatory system and communications strategyâ€¢ Foster global and national alliances â€¢ Strengthen institutional capacity with redesigned governance modelsâ€¢ Create a matrix of measurement of processes as well as outcomes These key elements would be implemented in collaboration and partnership with other ministries, departments, state governments and international agencies. The objective is to make India ready to meet the challenge of turning biotechnology into a $100bn industry by 2025. The National Biotechnology Development Strategy 2015-20 intends to: â€¢ Launch four major missions in healthcare, food and nutrition, clean energy and educationâ€¢ Create a technology development and translation network across India with global partnership, including 5 new clusters, 40 biotech incubators, 150 TTOs, and 20 bio-connect centresâ€¢ Ensure strategic and focused investment in building human capital by setting up a Life Sciences and Biotechnology Education Council The National Biotechnology Development Strategy 2015-2020 is the direct result of formal and informal consultations over the past two years with more than 300 stakeholders, including scientists, educators, policy makers, leaders of industry and civil society, voluntary and non-government organizations, regulators and international experts. The consultations offered an opportunity to discuss and evaluate technological, societal and policy aspirations, critical success factors as well as barriers that may impede growth, and put them in a newer and broader perspective and action plan. ]]> <![CDATA[Dengvaxia, first dengue vaccine approved in Brazil]]> https://biospectrumindia.com/news/95/7868/dengvaxia-first-dengue-vaccine-approved-in-brazil.html https://biospectrumindia.com/news/95/7868/dengvaxia-first-dengue-vaccine-approved-in-brazil.html Tue, 29 Dec 2015 11:10:48 +0530 Sanofi Pasteur, the vaccines division of Sanofi, announced that Brazil has granted regulatory approval to Dengvaxia, representing the third successful licensure of the dengue vaccine, which was also approved in Mexico and the Philippines earlier this month. The Brazilian regulatory authorities ANVISA approved Dengvaxia, tetravalent dengue vaccine, for the prevention of disease caused by all four dengue types in individuals from 9-45 years of age living in endemic areas. Dengue continues to hit hard in Brazil with over 1.4 million Brazilians directly affected by the disease during this year's outbreak season alone. Up to 70 percent of dengue cases in Brazil are reported in individuals 9 years and older, a highly mobile and socially active segment of the population who contributes to the spread of the disease within communities. Dengvaxia was shown to reduce dengue due to all four serotypes in two-thirds of the participants and prevent 8 out of 10 hospitalizations due to dengue and up to 93 percent of severe dengue cases. "This new Approval of Dengvaxia® by the ANVISA, a well-recognized and World Health Organization (WHO) certified regulatory authority is an important milestone for Sanofi Pasteur," said Dr Guillaume Leroy, VP of Dengue Vaccine, Sanofi Pasteur. "Dengvaxia has the potential to significantly reduce the dengue disease burden and to help Brazil reach the WHO's 2020 dengue reduction objectives." Dengue is a major public health priority in tropical and subtropical countries in Latin America and Asia. Sanofi Pasteur is introducing Dengvaxia first in these countries where the vaccine has the greatest potential to reduce dengue burden globally and help to achieve the WHO's goal to reduce dengue mortality by 50 percent and morbidity by 25 percent by 2020 in endemic countries. Sanofi Pasteur enrolled over 40,000 participants in extensive safety and clinical efficacy studies conducted mainly in endemic countries and built a dedicated vaccine production facility in France to secure adequate quality and quantity supply of the vaccine to meet endemic country demand upon introduction. ]]> <![CDATA[CCI approves Vivimed-Clariant deal]]> https://biospectrumindia.com/news/95/7894/cci-approves-vivimed-clariant-deal.html https://biospectrumindia.com/news/95/7894/cci-approves-vivimed-clariant-deal.html Mon, 28 Dec 2015 15:13:26 +0530 Vivimed Labs has informed BSE that the Competition Commission of India ("CCI") has granted its approval, under Section 31(1) of the Competition Act, 2002, with respect to the proposed acquisition of certain products in speciality chemicals division of the company by Clariant India. The order of the CCI will be received in due course of time. Other permits and approvals required for the acquisition are awaited and are expected shortly. In September this year, Vivimed Labs has entered into a definitive agreement for selling some of its specialty chemical products to Clariant Chemicals (India), a subsidiary of Switzerland-based Clariant AG, for Rs 380 crore. ]]> <![CDATA[Parsis desire to strive for excellence: Mr Arun Jaitley]]> https://biospectrumindia.com/news/95/7906/parsis-desire-to-strive-for-excellence-mr-arun-jaitley.html https://biospectrumindia.com/news/95/7906/parsis-desire-to-strive-for-excellence-mr-arun-jaitley.html Mon, 28 Dec 2015 12:39:23 +0530 "India needs more business leaders from the Parsi community emulating Mr Ratan Tata and Dr Cyrus Poonawalla, if it wants to emerge as the fastest growing economy in these adversarial global conditions," said Mr Arun Jaitley, Union Finance Minister. He was speaking at the concluding ceremony of the three-day Iranshah Udvada Utsav. The first ever 'Iranshah Udvada Utsav', a global congregation of the Parsi community was held from December 25-27, 2015 in Udvada, Gujarat. Mr Jaitley further said, "The most remarkable aspect of the community is the desire to strive for excellence and achieve it in an ethical way." He also said that the credit of throwing up role model leadership squarely belonged to the community. He mentioned former Solicitor General of India Mr Soli Sorabjee as his ethical guru for his sense of fairness and ethics. Mr Jaitley felicitated Mr Ratan Tata, chairman of Tata Group and Dr Cyrus Poonawalla, chairman of the Serum Institute of India (SII), at the ceremony. SII was founded in 1966 by Dr Poonawalla with the aim of manufacturing life-saving immuno-biologicals, which were in shortage in the country and imported at high prices. It is now the world's largest vaccine manufacturer by number of doses produced and sold globally (more than 1.3 billion doses) which includes Polio vaccine as well as Diphtheria, Tetanus, Pertussis, Hib, BCG, r-Hepatitis B, Measles, Mumps and Rubella vaccines. ]]> <![CDATA[FDA nod for Aurobindo's acid reflux treatment drug]]> https://biospectrumindia.com/news/95/7993/fda-nod-for-aurobindos-acid-reflux-treatment-drug.html https://biospectrumindia.com/news/95/7993/fda-nod-for-aurobindos-acid-reflux-treatment-drug.html Mon, 28 Dec 2015 12:03:09 +0530 Aurobindo Pharma announces that the company has received final approval from the US Food and Drug Administration (USFDA) to manufacture and market Famotidine Tablets USP, 20 mg and 40 mg. The approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) Pepcid Tablets, 20 mg and 40 mg, of Valeant Pharmaceuticals International. Famotidine Tablets is used for the short-term treatment of gastroesophageal reflux disease and active duodenal ulcer. The approved product has an estimated market size of $29 million for the twelve months ending October 2015 according to IMS. ]]> <![CDATA[SMS Pharma gets FDA approval for manufacturing unit]]> https://biospectrumindia.com/news/95/5972/sms-pharma-gets-fda-approval-for-manufacturing-unit.html https://biospectrumindia.com/news/95/5972/sms-pharma-gets-fda-approval-for-manufacturing-unit.html Mon, 28 Dec 2015 12:02:45 +0530 SMS Pharmaceuticals has received approval from the US Food and Drug Administration (US FDA) for its manufacturing facility located at Kandivalasa village in Vizianagaram district of Andhra Pradesh, the company said in a regulatory filing. The USFDA had conducted inspection of the plant in the third week of April 2015, it added. Hyderabad-based SMS Pharmaceuticals is engaged in manufacturing of active pharmaceutical ingredients (API) and currently has four production facilities and two research centers in operation. ]]> <![CDATA[UNICEF Ambassador Priyanka Chopra launches WIFS Awareness Campaign ]]> https://biospectrumindia.com/news/95/4842/unicef-ambassador-priyanka-chopra-launches-wifs-awareness-campaign-.html https://biospectrumindia.com/news/95/4842/unicef-ambassador-priyanka-chopra-launches-wifs-awareness-campaign-.html Thu, 24 Dec 2015 16:16:57 +0530 "It is our responsibility to ensure that the young energy is channelized in the right direction. This can only be achieved if the adolescents are physically and mentally well-prepared for the future of their country" said, Mr J P Nadda, union minister of health and family welfare. He was speaking on the occasion of launching of media campaign for the Weekly Iron and Folic Acid Programme (WIFS) under the Rashtriya Kishor Swasthya Karyakram (RKSK) programme of the Health Ministry. He also said that to provide one IFA tablet each to millions of adolescents every week is in itself a huge achievement. Nutrition among adolescents is one of the priority areas for concerted action under the Rashtriya Kishor Swasthya Karyakram. The minister said that the ministry is working continuously to strengthen the services provided under this programme and the support of the community i.e. parents, teachers and adolescents are critical to defeat anaemia. Also present at the function was Ms. Priyanka Chopra, UNICEF Goodwill Ambassador who is supporting the WIFS campaign by encouraging young adolescents to take one IFA tablet every week. The health minister stated that the association of Ms Priyanka Chopra's with this programme through the media campaign will help generate awareness on this critical issue. Sharing her experience, Ms Priyanka Chopra said that her health improved by taking iron tablet every week to remain healthy. Adding further she said, "I am sure through our concerted efforts we will be able to bring down the prevalence of anaemia amongst the adolescents." Highlighting the importance of IFA in one's diet, Mr BP Sharma, Secretary (Health) said, "Ministry is partnering with other departments to supplement food with Iron." He further added that awareness among adolescents about anaemia is low and Media can play a key role in delivering healthy messages across. Mr Louis-Georges Arsenault, UNICEF Representative for India commended the WIFS programme and highlighted the importance of "awareness" and "prevention" by simple and profound nutrition. He also laid emphasis on spreading awareness about anaemia among adolescents. The WIFS programme is implemented in both urban and rural areas among both adolescent boys and girls in school; and only to out of school adolescent girls (both married and unmarried). The WIFS strategy involves a "fixed day'' approach for WIFS distribution. It is recommended that Monday be the day on which all schools undertake the programme, with one additional designated day for absentees. To ensure high compliance in IFA supplementation supervised consumption of the IFA tablets is recommended. The programme also encourages and provides for the consumption of IFA tablets by the frontline workers such as AWW, ASHA, and teachers to enhance the value of WIFS among adolescents and community members. MoHFW is responsible for policy formulation, technical support, yearly planning of the WIFS programme, including the allocation of resources for supply of IFA supplements and deworming tablets, developing resource material for awareness, establishing monitoring systems and reviewing the programme progress. Under the WIFS programme for adolescents, IFA supplements are distributed free on a weekly basis to the target groups. In addition to IFA supplements, Albendazole tablets for de-worming are administered twice a year, to the same target groups. ]]> <![CDATA[Biocon introduces CIMIVIR-L for Hepatitis-C ]]> https://biospectrumindia.com/news/95/6982/biocon-introduces-cimivir-l-for-hepatitis-c-.html https://biospectrumindia.com/news/95/6982/biocon-introduces-cimivir-l-for-hepatitis-c-.html Thu, 24 Dec 2015 11:31:50 +0530 Biocon has announced the introduction of an advanced novel therapy CIMIVIR-L for the treatment of Hepatitis C in India. CIMIVIR-L is a fixed dose combination of Ledipasvir 90 mg and Sofosbuvir 400 mg, which is an equivalent of the innovator product commercialized by Gilead Sciences in the US. The Drugs Controller General of India (DCGI) recently approved the sale of Sofosbuvir-Ledipasvir combination, which is being manufactured in India under a license from Gilead. CIMIVIR-L, a once-a-day oral therapy, will offer a convenient, effective and safe alternative to people infected with the Hepatitis-C virus (HCV). It is estimated that nearly one lakh people die annually in India from HCV infection and co-morbidities. It is indicated for Hepatitis-C Genotype 1 patients who account for ~25 percent of the total estimated HCV patient population of 18 million in the country. CIMIVIR-L will be made available to patients in India at a fraction of the global cost of the innovator brand. The cost of a 12-week course of this combination therapy in the US is $94,500, (~ Rs 63 lakhs). In keeping with its commitment to introduce innovative therapies at an affordable price to patients, Biocon had entered into a licensing agreement last year with US-based Gilead to manufacture and commercialize its chronic Hepatitis-C blockbuster product range, Sofosbuvir and Sofosbuvir-Ledipasvir combination in India and in select emerging markets. Commenting on the launch, Mr Ravi Limaye, president - marketing, Biocon said, "The introduction of CIMIVIR-LTM will strengthen Biocon's current portfolio of Virology products. It furthers our commitment to offer affordable therapy for unmet patient needs in debilitating and life-threatening conditions. Through our patient support program we aim to create awareness on HCV to improve diagnosis and ensure better therapy compliance through patient education." Previous treatment regimens for Hepatitis-C Genotype 1 often involved multiple separate medicines and complicated dosing, which were largely difficult to tolerate. ]]> <![CDATA['Financing solutions, Digital Innovation key growth drivers for Healthcare']]> https://biospectrumindia.com/news/95/7630/financing-solutions-digital-innovation-key-growth-drivers-for-healthcare.html https://biospectrumindia.com/news/95/7630/financing-solutions-digital-innovation-key-growth-drivers-for-healthcare.html Thu, 24 Dec 2015 11:31:37 +0530 Siemens Financial Services (SFS) recently released a new research report examining how healthcare organizations around the world meet the sector's key challenges with smart finance. The qualitative research was conducted across 13 countries to inspect how healthcare finance managers deploy a wide range of financing techniques to combat obstacles faced by the global healthcare sector and improve service provision and patient outcomes. The research report highlights a very critical aspect that how healthcare providers face increasing pressure on capital budgets and struggle to meet increasing service demands and improved patient outcomes. Budget constraints often lead to extended use of outdated equipment and organizations are in the risk of losing patients to other players thereby showcasing the importance of Financing solutions and its impact on Customer Loyalty and Equity. In addition, research respondents who used new financing models such as Leasing and Rental were able to improve cash flows and control over budgets - enabling them to more effectively cater to escalating service demands and meet with other competitive pressures. "The healthcare sector is undergoing fundamental changes across the world, requiring providers to invest in top-quality service and care provision while maintaining or increasing returns to shareholders is the need of the hour. Financing techniques such as leasing can today enable healthcare providers to adapt seamlessly to market changes and raise over-all healthcare standards to attract more patients and provide improved standards of care," said Mr Sunil Kapoor- CEO, Siemens Financial Services. "We have had experiences, where smart financing solutions have enabled our customers to introduce quality healthcare to their patients. In an environment where healthcare is emerging and hence needs to be more accessible, providing financial support becomes a differentiator," said Mr Richard, Guest-CEO, Siemens Healthcare India. ]]> <![CDATA[Celgene settles REVLIMID patent litigation ]]> https://biospectrumindia.com/news/95/7675/celgene-settles-revlimid-patent-litigation-.html https://biospectrumindia.com/news/95/7675/celgene-settles-revlimid-patent-litigation-.html Thu, 24 Dec 2015 11:31:23 +0530 Celgene has announced the settlement of litigation with Natco Pharma of India, Natco's US partner, Arrow International, and Arrow's parent company, Watson Laboratories relating to patents for REVLIMID (lenalidomide). As part of the settlement, the parties will file Consent Judgments with the United States District Court for the District of New Jersey that enjoin Natco from marketing generic lenalidomide before the expiration of the patents-in-suit, except as provided for in the settlement, as described below. In settlement of all outstanding claims in the litigation, Celgene will permit entry of generic lenalidomide before the April 2027 expiration of Celgene's last-to-expire patent listed in the Orange Book for REVLIMID. Celgene has agreed to provide Natco with a license to Celgene's patents required to manufacture and sell an unlimited quantity of generic lenalidomide in the United States beginning on January 31, 2026. In addition, Natco will receive a volume-limited license to sell generic lenalidomide in the United States commencing in March 2022. The volume limit is expected to be a mid-single-digit percentage of the total lenalidomide capsules dispensed in the United States during the first full year of entry. The volume limitation is expected to increase gradually each 12 months until March of 2025, and is not expected to exceed one-third of the total lenalidomide capsules dispensed in the US in the final year of the volume-limited license under this agreement. Natco's ability to market lenalidomide in the US will be contingent on its obtaining approval of an Abbreviated New Drug Application. "We believe strongly in our patent estate for REVLIMID, and that this settlement appropriately recognizes the strength of our patents. This settlement provides clarity around the future of REVLIMID, and we will continue to focus on developing our many important pipeline assets, which provide great potential promise to patients with unmet medical needs. We remain confident in the strength of our patents, and will continue to vigorously defend them," said Mr Bob Hugin, chairman and CEO of Celgene. ]]> <![CDATA[FDA nod for Lupin's generic drug]]> https://biospectrumindia.com/news/95/7684/fda-nod-for-lupins-generic-drug.html https://biospectrumindia.com/news/95/7684/fda-nod-for-lupins-generic-drug.html Thu, 24 Dec 2015 11:30:59 +0530 Pharma Major Lupin has received final approval for its potassium chloride extended release Capsules USP, 8 mEq and 10 mEq from the United States Food and Drug Administration (US FDA). Lupin's US subsidiary shall commence promoting the product in the US shortly. Lupin's capsules USP, 8 mEq and 10 mEq, are the AB rated generic equivalent of Actavis Labs potassium chloride extended release capsules USP, 8 mEq and 10 mEq. It is indicated for the treatment of patients with hypokalemia, with or without metabolic alkalosis, in digitalis intoxications and in patients with hypokalemic familial periodic paralysis. It is also indicated for the prevention of hypokalemia in patients who would be at a particular risk. Potassium chloride extended release capsules had US sales of $85.6 million (IMS MAT September 2015). ]]> <![CDATA[Bangalore-based biotech start-up prints country's first artificial liver tissue]]> https://biospectrumindia.com/news/95/7770/bangalore-based-biotech-start-up-prints-countrys-first-artificial-liver-tissue.html https://biospectrumindia.com/news/95/7770/bangalore-based-biotech-start-up-prints-countrys-first-artificial-liver-tissue.html Thu, 24 Dec 2015 10:29:35 +0530 Pandorum is involved in the design and manufacturing of functional human tissues serving as test platforms for drug discovery and development, medical research, personalized therapeutics and other applications. For the first time in the country, it has created artificial liver tissue that behave and mimic the human liver tissue. "Liver cells are difficult to grow outside the human body. The global pharmaceutical industry spends about $10 billion and 10 years to develop new drugs. The cost of failure is high. The 2D culture and animal models are not human-like. We cannot test the effects of radiation on real human beings. Here artificially developed tissues will play a significant role as test platforms," said Mr Arun Chandru, cofounder & MD, Pandorum Technologies. According to the company, at the moment, in India, there are no other companies which are developing artificial human tissues. The artificial liver tissue is said to live for 4-8 weeks. Pandorum's team consists of Dr Tuhin Bhowmick as the chairman and cofounder, and Mr Arun Chandru. Today, companies in this area are capable of printing 10 million cells into a tissue which can help develop drugs that are affordable with better efficacy, lesser side effects, develop vaccines with quick turnaround time, and reduce animal and human trials. By 2020, with 3D printing technology, companies would be able to print 1 billion cells enabling creations like implantable tissues, and mini organs like skin, pancreas, blood vessels and liver lobes. In 2030, it is estimated that the technology will be so advanced and will empower companies to print 100 billion cells paving way for full-scale transplantable organs on demand, having the potential to fill the demand-supply gap in transplantation of organs like liver, kidneys, and pancreas. Currently, Pandorum is in talks with pharmaceutical companies to commercialize its services. The start-up has so far spent Rs 1 crore. It is also in talks with investors to raise further funding. Today, the global in vitro toxicity testing market is estimated to be worth $20-30 million. By 2018, it is predicted to touch $4 billion. Artificial human tissues are already being developed and commercialized in Japan, the US, England, Europe, and China. In the future, Pandorum intends to print other human body parts like bladder, skin, muscle, bone, heart, nerves, lungs, kidneys, and pancreas. In India, the organ supply-demand disparity is relatively higher. For every 50,000 livers and 50,000 hearts needed, only 1500 and 50 are fulfilled respectively. The numbers are far worse for kidneys. Only 7,000 transplantations are achieved out of a whopping 200,000 requirement. The start-up company is incubated at Centre for Cellular and Molecular Platforms (C-CAMP). The company was ideated in 2009. In 2010, the team participated in BEST-India (Biotechnology Entrepreneurship Student Teams) organized by Department of Biotechnology (DBT), and won a prize money of Rs 5 lakh. The following year Pandorum was incorporated. It has been a recipient of the Biotechnology Ignition Grant (BIG) in 2012. In 2013, it also received the 'Ignite' entrepreneurship fellowship by BIRAC (Biotechnology Industry Research Assistance Council) and Judge Business School, University of Cambridge, England. Last year, it benefited through Small Business Innovation Research Initiative (SBIRI) scheme from BIRAC, DBT, Ministry of Science & Technology, Government of India. ]]> <![CDATA[Practo releases Healthcare Map of India]]> https://biospectrumindia.com/news/95/7458/practo-releases-healthcare-map-of-india.html https://biospectrumindia.com/news/95/7458/practo-releases-healthcare-map-of-india.html Wed, 23 Dec 2015 12:28:52 +0530 Gastroenterologists were the fastest growing searched specialty across India in 2015, said Bengaluru-based firm Practo in its Healthcare Map of India 2015. The company said that the healthcare map has been compiled from data of over 75 million searches and over 40 million appointments on the company's platform in 2015. Worth also noting is that due to the high search-to-appointment ratio, the data also is a reasonable match for search intent versus action of visiting the doctor. This means that the data is not merely informational but is action oriented. The data throws up some interesting insights:1.Lifestyle diseases are rising and rising fast - and not just in top cities but across the board in tier 2 and tier 3 towns as well.2.There is growing number of Dermatology and ENT visits as well - perhaps signalling the growing air pollution we are witnessing in India.3.Gastric problems and Cardiac issues are amongst the fastest growing health concerns in India. "We are taking a stab at this by looking at our own data and making the insights available publicly so that we can spark and guide the conversation around what ails people in India and where healthcare efforts should be focused," wrote Practo in its blog. For more information on India and specifics on key cities, do check out this handy info graphic: ]]> <![CDATA[Piramal on acquisition spree]]> https://biospectrumindia.com/news/95/3640/piramal-on-acquisition-spree.html https://biospectrumindia.com/news/95/3640/piramal-on-acquisition-spree.html Wed, 23 Dec 2015 11:33:41 +0530 Piramal Enterprises'(PEL) Consumer Products Division announces the acquisition of five trademark rights for India from Organon India (OPIL) and MSD BV (Merck) for a consideration of Rs 92 crore. The acquisition includes mainly the brands Naturolax, Lactobacil and Farizym, which PEL intends to continue in the Gastro-Intestinal (GI) segment through the over-the -counter (OTC) route. Ms Nandini Piramal, executive director, Piramal Enterprises said, "Our aim is to be a significant player in all the businesses we have retained in the Healthcare segment of Piramal. We are one of the largest custom manufacturing companies and have manufacturing bases in North America, European Union and Asia. Our Critical Care business is the third largest player in the Global Inhalation Anesthesia market. The third business in Healthcare segment is the Consumer Product Business and we intend to be a significant player here too." She added, "In line with our strategy, we aim to be a Top 3 player in the OTC market by 2020 and the addition of this portfolio of brands will help us move swiftly towards that objective. Recently we have also acquired the babycare brand Little's, which provides well-being solutions for kids up to the age of 4 years. We currently have six of our brands in the top 100 OTC brands of India and this list will further increase with the recent addition of Little's and these brands from OPIL and MSD BV." Mr Kedar Rajadnye, COO, Consumer Products Division said - "The Consumer Product business of Piramal Enterprises caters to all 1 lac+ populations towns in India and committed to expand our distribution network further to over 20k population towns making it one of the largest distribution footprints in Indian OTC space." ]]> <![CDATA[Prevalence of pancreatic cancer will push the treatment market to $2.9 bn by 2021]]> https://biospectrumindia.com/features/95/7441/prevalence-of-pancreatic-cancer-will-push-the-treatment-market-to-2-9-bn-by-2021.html https://biospectrumindia.com/features/95/7441/prevalence-of-pancreatic-cancer-will-push-the-treatment-market-to-2-9-bn-by-2021.html Tue, 22 Dec 2015 16:33:00 +0530 The company's latest report states that this rise, which will occur across the eight major countries of the US, the UK, France, Germany, Italy, Spain, Japan and Canada, will come despite developments in diagnostics and a pipeline of promising new drugs. Mr Adam Bradbury, analyst for GBI Research, says that there are six pancreatic cancer drugs expected to gain approval within the forecast period, all of which have demonstrated significant improvement in progression-free survival and/or overall survival in clinical trials. He explains: "The six drugs expected to gain approval within the forecast period are Threshold's TH-302, Merrimack's Onivyde (in Europe), NewLink Genetic's HyperAcute Pancreas, Cancer Advances' G17DT, Immunomedics' Clivatuzumab Tetraxetan, and Incyte's Ruxolitinib Phosphate. "However, these drugs are not expected to significantly impact the market because of their high cost-to-benefit ratio, which will severely limit their sales by 2021." The report also states that as pancreatic cancer is a disease with a very poor prognosis, developing drugs with adequate cost-to-benefit ratios is very difficult, and this is reflected in the disease's high attrition rate of 91% over all three phases of clinical trials. Mr Bradbury explains: "The poor revenue prospects associated with developing pancreatic cancer therapies will mean many potential investors see it as an unwise investment. "Despite some improvements in failure rates, further elucidations of mutations and their effects on signaling pathways and disease progression will be required before effective combination therapies can be developed and a significantly lower failure rate achieved." The analyst adds that the current pancreatic cancer treatment market is dominated by the generic drug gemcitabine, which is the current standard of care and is widely used for its cost-effectiveness. He adds: "Even if priced similarly to gemcitabine, the very poor efficacies of the pipeline drugs in comparison to existing therapies would not offer strong cost-to-benefit ratios. "For this reason, most of the drugs likely to be approved during the forecast period will be administered as combination therapies, which will prevent companies charging premium prices and limit their market share." ]]> <![CDATA[ABLE-AG writes to PMO, Opposes cotton seed price control order]]> https://biospectrumindia.com/news/95/7417/able-ag-writes-to-pmo-opposes-cotton-seed-price-control-order.html https://biospectrumindia.com/news/95/7417/able-ag-writes-to-pmo-opposes-cotton-seed-price-control-order.html Tue, 22 Dec 2015 16:32:36 +0530 The ABLE-AG has expressed serious concern with regards to the recent decision by the ministry of agriculture and farmers welfare, government of India to regulate the maximum sale price of cotton seeds in the country. The order also aims to control the licence fee, Royalty trait fee and licensing terms on which technology providers make available innovative technologies for the benefit of Indian cotton farmers through cotton seed companies on extensively negotiated terms set out in mutually agreed bilateral private contracts. In its letter to the Prime Minister's Office (PMO) dated December 17, 2015, the ABLE-AG has sought an immediate meeting to discuss the issue. The same is addressed to Mr Nripendra Misra, principal secretary to PM and signed by Mr Ram Kaundinya, director general, ABLE-AG. It questioned the decision making process that involved no prior information, discussion, or consultation by the Ministry with the association or any of its constituent organisations or technology developer and provider and any other stakeholder in general. Commenting on the issue that has emerged as one of great concern to the industry, Mr Ram Kaundinya, "Being an association committed to the improvement of Indian agriculture through biotechnology, we strongly oppose the order and the manner in which it was adopted. While a part of the Order seeks to determine Maximum Sale Price of cotton seed under the Essential Commodities Act, it surprisingly extends to fixing a component thereof associated with innovation. We are saddened that such action has been taken without our Association or any member company being consulted on the same. We believe such a step hampers confidence in making investments in innovative research & development and is contrary to the Government's 'Make in India' campaign and impacts ease of doing business. We have also written to concerned ministries sharing our views in this regard." Speaking on the issue Dr Paresh Verma, head of management committee, ABLE AG said, "As was emphasized by the Prime Minister during his recent trip to US, respect for Intellectual Property Rights in agriculture would be critical in India as it would lead to increased investments in R&D for developing innovative solutions to increase productivity and farmers' income. Any policy that brings in adhocism related to potential return on investment will adversely influence research investment decisions of technology development companies." With introduction of Bt cotton since 2002, India is world's 2nd largest exporter of cotton from 2nd largest importer at the time of technology introduction. Cotton is a global commodity and global competitiveness is key for Indian farmers to compete in the world market. India produces cotton worth $10 billion annually of which $2.5 billion is exported. The domestic market consumes a value of $7.5 billion feeding a large part of it to the textile sector which capture value through further export. 7 million farmers are directly benefited from the cotton; as many as 20 million gets ancillary support in the form of farm labour. According to UK-based research group - PG Economics, higher cotton production and insecticide savings from Bt cotton seeds helped India's cotton farmers earn Rs. 42,300 crore of additional income between 2002 and 2010.Other studies including the one done by the Council for Social Development (CSD), titled, 'Socio-Economic Impact Assessment of Bt Cotton in India,' have found that higher returns from Bt cotton cultivation has empowered the farmers and landless labourers to increase their expenditure on improving their livelihood status. As per ABLE-AG, the Indian farmers' choice to plant hybrid cotton seeds with insect-protection Bt cotton technologies on over 90 per cent of cotton acres, and increased cotton production, is testament to the value created by better seeds, technologies and farming practices, when compared with the alternative of seed and insecticide sprays. ]]> <![CDATA[BCIL celebrates its Silver Jubilee]]> https://biospectrumindia.com/news/95/2952/bcil-celebrates-its-silver-jubilee.html https://biospectrumindia.com/news/95/2952/bcil-celebrates-its-silver-jubilee.html Tue, 22 Dec 2015 15:31:03 +0530 The Biotech Consortium India Limited (BCIL), New Delhi celebrated its silver jubilee with fervor and festivities were on December, 19 2015 at National Institute of Immunology (NII), New Delhi. On the occasion, the union minster for science and technology, Dr Harsh Vardhan was the chief guest of the programme. The company promoted by the department of biotechnology (DBT) and the all India financial institutions, since its inception in the year 1990, has made a significant contribution to biotechnology sector by providing valuable consultancy services to the central government, state governments, academia, research institutions and the industry. The programme began with the welcome address by Dr V P Kamboj, chairman, BCIL and Dr Manju Sharma, former secretary, DBT who apprised the audience about the genesis of BCIL and its journey over the last 25 years. Dr Purnima Sharma, managing director, BCIL presented the various activities of BCIL i.e. intellectual property management and technology transfer, consultancy, biosafety, capacity building and manpower development. Dr Sharma mentioned that BCIL is proactively contributing to the 'Make in India', 'Skill India' and 'Startup India' programmes by virtue of managing national programmes promoting commercialization and entrepreneurship development. While delivering the inaugural address, the chief guest, Dr Harsh Vardhan congratulated BCIL on the occasion of silver jubilee celebrations. He appreciated the vision and mandate of BCIL towards commercialization of biotechnology and emphasized the need of organizations like BCIL to assist the various Government departments in implementation of different projects. On this occasion, Prof K VijayRaghavan, secretary, government of India, Department of Biotechnology appreciated the strong foundation of BCIL which has been responsible for its achievements and its board of directors who have been providing the vision and direction to BCIL. He also expressed his intent in working closely with BCIL in executing other important programmes of DBT. While addressing the gathering, Prof Ashutosh Sharma, secretary, department of science and technology (DST) congratulated BCIL and suggested that BCIL should expand its scope of activities by working with other government departments. The proposed initiatives for scale-up of technology incubators already set up across the country and conducting technology mapping/foresight studies. The event had a participation of around 300 delegates from government, industry and academia from national and international forums. To commemorate this special occasion, BCIL had organized special lectures on biotechnology commercialization delivered by eminent personalities from the field of science and technology - Dr Renu Swarup, senior advisor, DBT and managing director, BIRAC, Dr Balram Bhargava, professor of Cardiology and executive director, School of International Design, Dr Ram Vishwakarma, director, CSIR- Indian Institute of Integrative Medicine, Jammu, Dr Krishna Ella, chairman and managing director, Bharat Biotech International and Mr Rajendra Barwale, managing director, Mahyco Seeds. BCIL had also an exhibition of the key activities of BCIL and the Chief Guest, dignitaries and participants appreciated the achievements of BCIL. ]]> <![CDATA[Strides Shasun gets DCGI nod to manufacture Sofosbuvir]]> https://biospectrumindia.com/news/95/7335/strides-shasun-gets-dcgi-nod-to-manufacture-sofosbuvir.html https://biospectrumindia.com/news/95/7335/strides-shasun-gets-dcgi-nod-to-manufacture-sofosbuvir.html Tue, 22 Dec 2015 10:56:54 +0530 Strides Shasun has announced that it has received approval for manufacturing generic version of Sofosbuvir 400 mg (Gilead's Sovaldi) from Drug Controller General of India (DCGI). In September 2014, Strides entered into a licensing agreement with Gilead Sciences to bring Hepatitis C cure to 91 developing countries. The product will continue tobe marketed under the brand name 'Virso' in India and overseas. Sofosbuvir is the first-in-class NS5B polymerase inhibitor to be launched in India for Hepatitis C treatment and represents a paradigm shift in the existing Hepatitis C cure. The high potency, high barrier to resistance, pan genotypic activity, once-daily dosage, good safety profile and the limited drug-drug interactions of Sofosbuvir makes it a breakthrough drug in Hepatitis C treatment. This drug in combination therapy has shown to have high cure rates of around 90 percent. Globally, it is estimated that 170-185 million people (about 3 percent of the world's population) are chronically infected with Hepatitis C virus (HCV). In India alone, it is estimated that 12-18 million patients are infected with Hepatitis C, which is several fold greater than those with HIV/AIDS. ]]> <![CDATA[Glenmark receives ANDA approval for Linezolid Tablets]]> https://biospectrumindia.com/news/95/3132/glenmark-receives-anda-approval-for-linezolid-tablets.html https://biospectrumindia.com/news/95/3132/glenmark-receives-anda-approval-for-linezolid-tablets.html Tue, 22 Dec 2015 10:55:56 +0530 Glenmark Pharmaceuticals (Glenmark) has been granted final approval by the United States Food and Drug Administration (US FDA) for Linezolid Tablets, 600 mg. The drug is therapeutic equivalent of Zyvox Tablets, 600 mg of Pharmacia and Upjohn Company, a subsidiary of Pfizer. According to IMS Health sales data for the 12 month period ending October 2015, the Zyvox Tablets, 600 mg market achieved annual sales of approximately $447.6million. ]]> <![CDATA[Merck gets FDA nod for Bridion ]]> https://biospectrumindia.com/news/95/7031/merck-gets-fda-nod-for-bridion-.html https://biospectrumindia.com/news/95/7031/merck-gets-fda-nod-for-bridion-.html Tue, 22 Dec 2015 10:33:00 +0530 Merck (MSD) has recieved US Food and Drug Administration (FDA) approval for Bridion (sugammadex) Injection 100 mg/mL (equivalent to 108.8 mg/mL sugammadex sodium) for the reversal of neuromuscular blockade (NMB) induced by rocuronium bromide and vecuronium bromide in adults undergoing surgery. Bridion works differently than neostigmine, an agent used to reverse non-depolarizing neuromuscular blocking agents (NMBAs) by increasing the neurotransmitter acetylcholine at the neuromuscular junction. Bridion forms a complex with the non-depolarizing NMBAs rocuronium and vecuronium, thereby removing these agents from the neuromuscular junction and facilitating the return of muscle function. Unlike neostigmine, Bridion can be used to reverse different levels of rocuronium and vecuronium-induced NMB, including deep block (1-2 post-tetanic counts [PTCs]). "The FDA approval of Bridion reflects Merck's continued commitment to develop medicines that address unmet needs," said Dr David Michelson, vice president, Neurosciences, Merck Research Laboratories. "With Bridion, we now have a new option with a different mechanism of action to reverse neuromuscular blockade induced by rocuronium and vecuronium in adults undergoing surgery." Bridion is contraindicated in patients with known hypersensitivity to sugammadex or any of its components. Hypersensitivity reactions that occurred varied from isolated skin reactions to serious systemic reactions and have occurred in patients with no prior exposure to sugammadex. ]]> <![CDATA[Hot Start-up: PMS for Biotech, Pharma cos]]> https://biospectrumindia.com/features/95/3278/hot-start-up-pms-for-biotech-pharma-cos.html https://biospectrumindia.com/features/95/3278/hot-start-up-pms-for-biotech-pharma-cos.html Tue, 22 Dec 2015 10:31:40 +0530 Back then, Bio-excellence functioned as a not-for-profit organization for skills development in Biotechnology. Dr Ravi says that post his first failure, he continued started grooming himself, and was fortunate enough to have a valuable mentor like Mr Sandeep Saxena, the founder and CEO of Acton Biotech. His second new venture, Inbiosys, provides project management services (PMS) to pharmaceutical and biotechnology companies engaged in the development, manufacturing and marketing of chemical drugs, biosimilars, vaccines, recombinant proteins and in-vitro diagnostic reagents. Inbiosys serves its clients through three services including establishing project portfolio management processes, managing third-party outsourced projects to CROs and CMOs, and project management training. "Smaller and virtual companies do not have well-defined project management teams to work their way up. We help pharmaceutical and biotech companies to set up project management practices. Also, small and mid-sized companies in innovation clusters outsource their projects management needs to India and Asia. We help plan, manage and execute their projects. We also provide project management training to Life Sciences professionals," explains Dr Ravi He further adds that today the project management in the biotech and pharma industry is not up to the mark. "I don't see a well-established management function independently working in these two industries. They have adopted the matrix structure having functional departments," he points. Dr Ravi previously worked with Biocon's subsidiary, Syngene International, a contract research and manufacturing organization. He holds a PhD from Amravati University. He comes with 11 years of vast and rich experience in the industry. It was challenging for him to prepare himself to transition from being an employee to a full-time entrepreneur. "It took 2 to 3 years to ensure I had enough cash to manage the company. Selling our services is a big challenge. Our start-up is a new idea and convincing people in the industry is another task. Getting the right talent to work with us and drive along with the vision and mission of Inbiosys was daunting," he reveals. In 2008, he enrolled with IIM-Kolkata and completed his Executive Program in Business Management. His years of experience and huge web of industry network came in handy while incorporating Inbiosys. "I had a big network in the industry. We had clients and customers even before we started. Networking is a big key. So we had our customer base ready even before starting Inbiosys. We got some of our clients through social media as well," states the scientist-turned-entrepreneur. Dr Ravi didn't stop there. In November 2014, he founded and launched an exclusive recruitment online platform DNAJOBZ, designed specifically for the Life Sciences professionals and companies seeking employment and talents. "Helping Life Science professionals find the right career avenues, and helping Life Science employers find the right talent," he wrote on a website. Going forward, Inbiosys is ambitious to expand to the US, Europe and Singapore. "Expanding our customer base in the next 1 to 2 years is crucial for us," observes Dr Ravi. He lays emphasis on starting up to learn the nuances of business. "If you want to start a business then just start doing it. One should carry out risk and market analysis. Taking calculated risks is important. Follow a risk-based approach. If you want to start then start immediately. You will learn the nitty-gritty of business when you actually do it. Have good mentors," he advices. ]]> <![CDATA[CCI nod for Piramal-DiaSys Diagnostic deal]]> https://biospectrumindia.com/news/95/7782/cci-nod-for-piramal-diasys-diagnostic-deal.html https://biospectrumindia.com/news/95/7782/cci-nod-for-piramal-diasys-diagnostic-deal.html Mon, 21 Dec 2015 16:13:39 +0530 Competition Commission of India (CCI) has approved the acquisition of Piramal Enterprises' lab diagnostics and point-of-care business by DiaSys India. "@CCI_India approves acquisition of Lab Diagnostics and Point of Care Business of Piramal Enterprises by DiaSys India," CCI tweeted. In 2014, Piramal Enterprises signed a deal to sell the division to DiaSys Diagnostic Systems GmbH for Rs 13 crore. Germany-based DiaSys Diagnostic Systems GmbH has acquired the Diagnostic business of Piramal Enterprises through its subsidiary in India, DiaSys Diagnostics India. Piramal Diagnostic has been the DiaSys distributor in India before and marketed two product lines - lab diagnostics and point-of-care products - very successfully in the Indian market. With this acquisition, DiaSys will invest in India and will further expand its presence through its quality systems and expertise. DiaSys will also develop a new R&D center with a concerted road map with the global DiaSys R&D centers, and consequently launch international activities based out of India. ]]> <![CDATA[Glenmark settles dispute with Forest Laboratories ]]> https://biospectrumindia.com/news/95/7128/glenmark-settles-dispute-with-forest-laboratories-.html https://biospectrumindia.com/news/95/7128/glenmark-settles-dispute-with-forest-laboratories-.html Mon, 21 Dec 2015 13:15:30 +0530 Glenmark Pharmaceuticals has announced that they have entered into a settlement agreement with Forest Laboratories and Royalty Pharma Collection Trust, to settle and dismiss the outstanding patent litigation related to Glenmark's Abbreviated New Drug Application for Milnacipran Hydrochloride 12.5 milligram, 25 milligram, 50 milligram, and 100 milligram tablets, the generic version of Forest's Savella. Under the terms of the Settlement Agreement, Glenmark will have the option to market and distribute its Milnacipran Hydrochloride tablets or an authorized generic version of Savella tablets. Other terms of the Settlement Agreement are confidential. According to IMS Health sales data for the 12 month period ending October 2015, Savella achieved annual sales of approximately $134.7 million. ]]> <![CDATA[Now, FDA issues warning letter to Sun Pharma]]> https://biospectrumindia.com/news/95/7086/now-fda-issues-warning-letter-to-sun-pharma.html https://biospectrumindia.com/news/95/7086/now-fda-issues-warning-letter-to-sun-pharma.html Mon, 21 Dec 2015 13:14:55 +0530 Sun Pharmaceutical has announced that it has received a warning letter from the US Food and Drug Administration (US FDA) as a result of the September 2014 inspection, for its facility located at Halol, Gujarat in India. Sun Pharma responded to the US FDA inspection observations with a robust remediation process that is still on-going, with significant investments in automation and training to enhance its Quality Systems. Sun Pharma has been working with external consultants to ensure its remediation activities have been completed in an appropriate manner. Commenting on the development, Mr Dilip Shanghvi, managing director, Sun Pharma said, "While our team is working hard to ensure that the commitments made to the US FDA in September 2014 are fully completed, we will continue to cooperate with the US FDA and undertake any additional steps necessary to ensure that the US Agency is completely satisfied with our remediation of the Halol facility. Sun Pharma has always ensured that its products are safe and effective and there is no doubt on the safety of our products in the market. We are pledged to being cGMP compliant and are committed to continuing to supply our customers and patients across the world with quality products that meet all specifications." Since the inspection in September 2014, Sun Pharma has communicated regularly with the US FDA on the progress of its remediation and on issues of product supply. It has provided periodic updates to the US FDA on its commitments. Post the September 2014 inspection, the US FDA has withheld future product approvals from the Halol facility. This situation may continue until all issues are resolved. Sun Pharma expects to request a re-inspection by US FDA upon completion of its remediation commitments. Sun Pharma and the Halol facility will continue to supply important drug products to meet its obligations to its customers and the patients who use its drugs in the United States and around the world. The company said it will respond to this warning letter with a detailed plan within the stipulated time frame. ]]> <![CDATA[India's trillion-dollar opportunities in ICT, IoT]]> https://biospectrumindia.com/features/95/8296/indias-trillion-dollar-opportunities-in-ict-iot.html https://biospectrumindia.com/features/95/8296/indias-trillion-dollar-opportunities-in-ict-iot.html Mon, 21 Dec 2015 10:34:20 +0530 In recent years, Internet of Things (IoT) has emerged as a buzzword, with both service providers and businesses, exploring possibilities connected devices can bring to the services they render and the way they conduct their businesses. IoT solutions are impacting the healthcare in a significant manner. Today, enterprises are realizing that the adoption of IoT in their operations will not only lead to increased productivity and process efficiencies, but also a reduction of costs. As a society, we are becoming more connected and the pace at which new technology is impacting our everyday lives is increasing at lightning speeds. IoT, M2M, ICT Over the next decade, the IoT and M2M (machine-to-machine) are expected to bring billions of data-generating devices online, and connect a vast stream of data with people, processes and other devices. There are some niche applications such as sensors record, ambulatory medical record (AMR) modem, and asset tracking. "In the pharma and healthcare industries," says Mr Sai Pratyush, Additional VP, Managed Services, Tata Teleservices, "we see the increasing use of IoT in the form of people connecting to various healthcare devices. Also the use of wireless technology will allow healthcare workers and patients to rapidly access information. M2M communication connected wirelessly via sensors that transfer data automatically will improve efficiencies." The healthcare industry has long been overburdened by slow #mce_temp_url#moving innovation due to the complexity of the medical ecosystem that's changing aggressively, and IoT and M2M solutions are playing a catalyst role in this change and revolutionizing the pharma sector. "It will also be helpful in providing better medication-management and will be the fastest growing segment in the whole IoT market," predicts Mr Pratyush. Technology is playing a significant role in improving the quality of healthcare, cost efficiency, precision performance, proactive and on-time care, real-time communication and most importantly, saving lives. Tata Teleservices is working with partners to develop scalable ICT (Information and Communication Technologies) and IoT solutions across the healthcare value chain which includes hospitals, vendor ecosystem, doctors and individuals. The following are few areas which will see innovation, and will benefit both the industry as well as patients: â€¢ Outpatient monitoringâ€¢ Wearables â€¢ Remote monitoring or rural healthcareâ€¢ mHealth â€¢ Location based services ICT Trends In Indian Healthcare ICT and IoT solutions are impacting the healthcare in a significant manner. There is the wearables space which is enabling and pushing ordinary people to maintain a healthy lifestyle, and then, there are those simple innovations which are enabling the healthcare industry to provide better quality of care to its patients. Outpatient monitoring and telemedicine applications are introducing the healthcare industry to newer ways of interaction with patients and enabling them to not only monitor patients on a continuous basis but also respond more quickly to situations that need their attention. "As an example, a monitoring device is given to the patient at the time of discharge for a limited time frame, which helps the doctor to continue to monitor the patient and suggest corrective actions during the patient's recovery," states Mr Pratyush. As per a Deloitte Report, telemedicine is witnessing fast adoption in India. In 2012, the telemedicine market in India was worth $7.5 million, and it is expected to rise 20% annually to $18.7 million by 2017. Telemedicine can provide low-cost consultation and diagnostic facilities to the remotest areas via high-speed Internet and telecommunications, thus, bridging the rural-urban divide. In addition, India's extensive mobile technology infrastructure and better connectivity infrastructure is expected to drive mobile health (mHealth) adoption further. He points, "Several people in our country do not have ready access to decent healthcare. There are many challenges to set up a full-fledged hospital at remote and rural locations. However, IoT-based wireless solutions are now making it possible for doctors based in cities to monitor patients located in remote villages. Now, villagers need not travel long distances to get a simple diagnosis done." Mr Pratyush feels that solutions need not involve complex ICT infrastructure. "SMS-based solutions are enabling doctors and hospitals to send reminders and alerts to their patients on medication or health checkups. "This management of medication through SMS platform ensures doctors and hospitals provide best possible care to their patients," he adds. Challenges To Disruption Despite being an IT-enabled services behemoth, the use of ICT in the healthcare sector is limited in India. The major users of ICT include big pharmaceutical companies, corporate hospitals and other private health sector institutions, while the public healthcare sector is lagging way behind in IT utilization. But the good news is that the situation is changing. Mr Pratyush mentions, "Though ICT solutions have had a positive impact on the healthcare sector, there are some challenges that need to be overcome in order to provide affordable, high-quality healthcare solutions, and innovations to hospitals and their vendor ecosystem, doctors, and eventually the citizens of this country." The Government is now cognizant that technology can help overcome challenges arising due to geographical size, high-population density, lack of healthcare infrastructure, inaccessibility in rural India, poor nutritional conditions, and low literacy, among others. Furthermore, the National Health Policy endorsed by the Parliament of India encourages the introduction of electronic communication media in health sector. The Government of India also brought in the National Rural Health Mission for delivering the best-in-class healthcare facilities to the rural population. The Ministry of Health and Family Welfare and the Ministry of Communication and Information Technology are jointly creating a national health information infrastructure for easy capture and dissemination of health information. Like all new disruptive technologies, IoT deployments face numerous challenges. "With connected IoT devices, reliable bidirectional signaling is essential for collecting and routing data between devices. You need to be 100% sure that that stream of data is going to arrive at its destination every time," emphasizes Mr Pratyush. Security is another important factor in IoT connectivity. "What good is a smart home if anyone can unlock your doors, or for that matter anyone can access your health records?" asks Mr Pratyush. "Solutions need to ensure that when sending or receiving a stream of data, the IoT device or server has proper authorization to send or receive that stream of data, and most importantly, you need end-to-end encryption between devices and servers." Huge and uninterrupted power consumption is also seen to pose challenges. "Billions of IoT devices which are required to transmit data between one another will require uninterrupted power either through the grid or battery bank," he stresses. Currently most solutions deployed in the country are based on proprietary technologies which make it difficult for customers to scale or opt out in case the solutions are not working for them. Tata Teleservices is working with partners to create innovative ICT solutions for the healthcare Industry. These solutions address the basic needs of providing telecom infrastructure as well as more complex IoT solutions such as LBS (Location-based services) or healthcare-related applications. Trillion-Dollar Opportunity As far as the IoT market opportunity is concerned, while findings of market research companies may vary, they are unanimous in their conclusion that this is a trillion-dollar opportunity in terms of revenue potential. A recent study by a global networking major predicted that there will be 25 billion devices connected to the internet by 2015, and 50 billion by 2020, thus highlighting its prominence in the coming decade. Mr Pratyush explains, "We have seen IoT and M2M deployments primarily in the utilities and transportation space, but that is changing slowly. As the devices, sensors and application ecosystems grow, we are seeing investments being made across BFSI (Banking, Financial Services and Insurance), retail, healthcare and even the home and building management space. The Government of India is also playing a significant role in adopting 'smart IoT technologies'. The 'Smart Cities' program as well as 'Digital India' is leading entrepreneurs to make substantial investments in this space." Globally, IoT has seen deployments across transport, utilities, retail, logistics, home automation and security. "The West is definitely a few steps ahead in terms of use cases and scale of deployments, but it would be incorrect to say that we are 'very' far behind," he opines. "The next few years will be critical for India, and I believe we have a good opportunity to bridge the gap. The Government's 'Digital India' program and 'Smart Cities' initiatives will further the cause of IoT substantially." The Cloud Adoption Though cloud computing is still a concept that exists only in theory for the Indian healthcare industry, the healthcare vertical has made it to the potential list of every Cloud vendor and service provider. Mr Pratyush says, "It is not surprising, given the general opinion that healthcare industry is rapidly automating itself, and soon enough, will be leapfrogging towards the Cloud." Research agencies like Zinnov have derived that the healthcare industry currently spends only about 2% of their total budgets on IT. This figure is set to grow to 15 to 20% in 2015, and upto 40% in 2020, purely towards adoption of Cloud services. This will mean that the Cloud opportunity within the healthcare segment could touch $600 million in 2020. At a CAGR growth rate pegged at 25%, healthcare is definitely one of the most promising segments as far as Cloud adoption is concerned. Healthcare A Key Vertical Tata Teleservices has been developing IoT solutions for its customers across a host of use cases and industries which includes the healthcare industry. "Our solutions encompass not only the telecom infrastructure but the devices and application as well in select verticals. Healthcare is a key vertical, and we are working with partners to create solutions which will be beneficial for our customers," concludes Mr Pratyush. It is also working with Government agencies to bring about standardization in the IoT space in India. Tata Docomo and its representatives are playing a leading role in the working groups, setup by the Telecommunication Engineering Center (TEC) in the areas of utilities, LBS, security & surveillance, and more recently, smart cities. ]]> <![CDATA[AML treatment market will soar beyond $930 mn by 2024]]> https://biospectrumindia.com/news/95/6328/aml-treatment-market-will-soar-beyond-930-mn-by-2024.html https://biospectrumindia.com/news/95/6328/aml-treatment-market-will-soar-beyond-930-mn-by-2024.html Fri, 18 Dec 2015 13:15:52 +0530 The treatment market for Acute Myeloid Leukemia (AML) will rapidly expand in value from $342.7 million in 2014 to reach $932.6 million by 2024, representing a Compound Annual Growth Rate (CAGR) of 10.5%, says research and consulting firm GlobalData. According to the company's latest report, this huge increase, which will occur across the seven major markets (7MM) of the US, Japan, the UK, Spain, Italy, France and Germany, will primarily be due to the launch of new therapies for AML patients with high unmet needs. Dr Sorcha Cassidy, GlobalData's Analyst covering Oncology and Hematology, says the greatest unmet need in the market is improving the overall survival rate of elderly AML patients which, compared to that of younger favorable-risk patients, is substantially lower. Dr Cassidy comments: "Fulfilling this unmet need is a safe route to regulatory approval and commercial success. In this way, one of the major drivers of AML treatment sales across the 7MM will be the launch of premium-priced therapies for elderly AML patients, such as Ambit's quizartinib. "Other growth drivers will include an increasing branded drug treatment rate, a rising number of refractory/relapsed cases of AML across all age groups, and a growing desire to develop immunotherapies to treat AML patients." The report also states that by 2024, the branded AML market leader will be Vyxeos, with estimated total sales of $131 million in the US and five European countries. Dr Cassidy concludes: "GlobalData does not believe the efficacy of Vyxeos will be exceptional, but it will be an improvement on the current standard of care. "However, the drug's premium price, the sizeable population of elderly AML patients, and the absence of immediate competition will drive higher sales from Vyxeos than any other pipeline or marketed product." ]]> <![CDATA[BioProcessing 2015: An eye opener on innovation in biological engineering of cells ]]> https://biospectrumindia.com/reports-white-papers/95/6689/bioprocessing-2015-an-eye-opener-on-innovation-in-biological-engineering-of-cells-.html https://biospectrumindia.com/reports-white-papers/95/6689/bioprocessing-2015-an-eye-opener-on-innovation-in-biological-engineering-of-cells-.html Fri, 18 Dec 2015 11:35:45 +0530 Jointly organized by IIT Madras, Anna University and VIT University, Bio Processing India 2015 kickstarted yesterday at the IC & SR Auditorium of Indian Institute of Technology, Madras (IIT-M). Bio Processing India (BPI), an annual conference, was first organized by IIT Delhi in 2013 and co-hosted by the Institute of Chemical Technology (ICT), Mumbai and IIT Bombay in 2014. The event this year is held over three days from Dec 17 to 19, 2015. The theme of this year's conference is 'Innovative Bioprocesses with Engineered Cell Factories'. BPI 2015 is bringing together leading universities, research institutions and biotech industries, making the conference a common platform for aspiring bioprocess engineers and biotechnologists to promote information exchange, networking and form strategic alliances. The focus of the conference and the exhibition is on current bioprocess methodologies from engineering cells to manufacturing strategies with emphasis across different verticals in the food, bioenergy and pharmaceutical industries. The conference has plenary lectures, invited talks, oral and poster presentations, webinars and panel discussions. Throughout the course of the conference, attendees have the opportunity to network with international academia and eminent speakers from the biotechnology industry. At the inauguration of the conference, Dr. T. Ramasami, Former Secretary, DST and Former Director, CLRI, expressed, "Bioprocessing offers a different twist to the current technologies in pharmaceutical science. This conference would set an ideal platform for knowledge evolution in bioprocessing techniques and its future. Scientists must exploit this conference to look beyond the current technologies available and conceive ideas that can solve problems with the aid of bioprocessing. Highlighting the objectives of BPI 2015, IIT-M Professor Guhan Jayaraman, the key organizer of the event, said, "Bioprocess engineering has come a long way from a process oriented approach to one where engineering biomolecules and cellular process have become an integral part of the bioprocessing strategy. The conference aims to focus on current bioprocess technologies from engineering cells to biomanufacturing for various industries. There is a rapid evolution in synthetic biology and this conference aims to catalyze information exchange in the bioprocessing community. Innovation has stepped up in bioprocessing with additional support from systems biology, computational tools for data analysis and production techniques. The conference will bring together information on newer aspects of biosprocessing." Biocon, Novozymes, Eppendorf, GE are some of the key sponsors and participants of the conference. Some key presentations at the event are focusing on engineering microbes for biofuel production; microbial production of bio-based chemicals, vaccines and industrial enzymes. The speakers are also projecting on streamlining the bioprocess technologies and the adoption of modern approaches in engineering. ]]> <![CDATA[Another FDA approval in Aurobindo's kitty]]> https://biospectrumindia.com/news/95/6186/another-fda-approval-in-aurobindos-kitty.html https://biospectrumindia.com/news/95/6186/another-fda-approval-in-aurobindos-kitty.html Fri, 18 Dec 2015 11:05:20 +0530 Aurobindo Pharma has received final approval from the US Food and Drug Administration (US FDA) to manufacture and market Methylprednisolone Sodium Succinate Injection USP, 40 mg/vial, 125 mg/vial, 500 mg/vial, and 2 g/vial. The approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) Solu-Medrol, of Pharmacia and Upjohn. Methylprednisolone Sodium Succinate Injection is a lyophilized product used in the treatment of various medical conditions viz allergic states, disorders etc. The approved product has an estimated market size of $102 million for the twelve months ending October 2015, according to IMS. ]]> <![CDATA[AstraZeneca to buy Takeda's respiratory business]]> https://biospectrumindia.com/news/95/7912/astrazeneca-to-buy-takedas-respiratory-business.html https://biospectrumindia.com/news/95/7912/astrazeneca-to-buy-takedas-respiratory-business.html Thu, 17 Dec 2015 14:01:35 +0530 AstraZeneca has announced that it has entered into a definitive agreement to acquire the core respiratory business of Takeda Pharmaceutical. The deal will include the expansion of rights to roflumilast (marketed as Daliresp in the US and Daxas in other countries), the only approved oral PDE4 inhibitor for the treatment of chronic obstructive pulmonary disease (COPD). AstraZeneca has marketed Daliresp in the US since the acquisition of the rights from Actavis in the first quarter of 2015. Full acquisition of the global rights will support AstraZeneca's respiratory franchise and complement the company's portfolio of treatments for severe COPD. Recent data reinforce the benefit Daxas brings to patients in reducing exacerbations as an add-on to dual and free-triple inhaled combination therapies. The agreement will also provide AstraZeneca with access to other marketed respiratory medicines and early pipeline products. Under the terms of the agreement, AstraZeneca will make a payment of $575 million. Approximately 200 staff will transfer to AstraZeneca upon completion. Mr Luke Miels, executive vice-president, global portfolio and product strategy at AstraZeneca, said, "The agreement with Takeda complements our respiratory business, one of our three main therapy areas, supports our return to growth and will be immediately accretive to earnings from 2016. Daxas in particular adds to our portfolio of treatments for patients with severe COPD." The transaction will be accounted for as a business combination and is expected to close during the first quarter of 2016, subject to customary closing conditions. It is expected to be immediately accretive to earnings from 2016. The acquisition of global rights to Daliresp will also negate the Company's existing royalty payments for the medicine in the US. Full Year 2016 guidance is expected to be provided at Full Year 2015 results on 4 February 2016. ]]> <![CDATA[Indian market has a promising future: IKA]]> https://biospectrumindia.com/interviews/95/5180/indian-market-has-a-promising-future-ika.html https://biospectrumindia.com/interviews/95/5180/indian-market-has-a-promising-future-ika.html Thu, 17 Dec 2015 14:01:08 +0530 It first ventured to India in 2008, and has eight locations on four continents across the globe. Mr Erhard Eble, the VP of IKA Group was recently in India and spoke exclusively with BioSpectrum's Raj Gunashekar. He talks about the company's experience in India thus far, the factors that have contributed to its growth, future plans, and the company's strategies for continued success in a challenging market like India. Edited excerpts:Q: What trends do you see in the lab and processing equipments market in India? A: The market in India today is very good and it has tremendous potential opportunity, and we are seeing many more international companies setting up subsidiaries here in India. We have learned that customers in this market require high quality lab and processing equipment and the trend we are seeing at IKA points to success similar to that which we have experienced in major markets such as India. Q: What were your challenges while entering the Indian market? A: India is geographically a very big country and reaching as many potential customers as possible is very challenging and takes time. So, we established regional sales locations to deliver information faster to customers and have our own on-site service engineers providing the fastest service possible. While our products are the best in their class, the biggest challenge is in expanding that coverage without sacrificing the quality of our service. Q: How do you tackle a price-conscious market like India? A: Customers are price-conscious everywhere. We are a global manufacturer that produces products in India, Malaysia, Brazil, the US and China, and of course, Germany, in order to offer our products worldwide. Our products are produced using only the highest quality materials, to the exacting standards of German engineering. That is why we can say 'made by IKA' with pride, especially with customer service and support that is second to none. Q: Do you see any differences between the German market and the Indian? A: The German market is mature and highly saturated, and IKA has very loyal customers in Germany and throughout Europe because of a long history built on quality and service. But, this is not yet the case in India. If you provide quality and excellent customer service, you will develop a reputation for it and becoming easier over time, to win-over the market. Q: Do you face competition from smaller players in India? A: The competition in India is similar to other world markets. We do have local competitors. We believe, the key to success is to have local offices to provide as much customer support as possible. Q: How did IKA perform financially in the last couple of years? A: Our business is good in Europe and the US, and we have experienced very good growth in China. India is now becoming a significant player and a large contributor to our growth. Sales in China have been stronger, but only because we started there earlier. Q: What has driven IKA's growth here in India? A: The chemical and pharmaceutical industries greatly contributed to our growth. Q: How much of your revenues go into your R&D? A: Our R&D happens in the head office in Staufen, Germany. Several million Euros go into it. Q: Any M&As planned in India? A: M&As are not our strategy. We are a family-owned business as old as history, and our strategy has always been to be innovative in developing new products which fit our customers' needs. We have always developed our own products, and IKA is continually bringing new products to market, and upgrading existing products with new features and functions thereby increasing the suite of products we offer. Q: Tell us about the company's plans in India. A: Our training is done here in Bangalore, where we invite customers, distributors, partners and our service engineers. So, we would like to be present on-site for our customers more. That's our key. We also have close relationships with universities in India, working on the needs of customers. Accordingly, we customize all our products to their needs. This helps us to identify new trends and address market demands. Q: Further expansion to other continents? A: We haven't planned to immediately expand to other continents but we would be open to it, if that market shows to be too-good-to-ignore. We are not too overly conservative at IKA, and we have always kept an eye on the horizon. When we ventured into the US 30 years ago, we did it with a pioneering spirit that succeeded. We are now looking forward to grow, still further in India, because its market is young, dynamic, and has a very promising future. ]]> <![CDATA[Key trends in Pharma sector- 2015]]> https://biospectrumindia.com/news/95/6552/key-trends-in-pharma-sector-2015.html https://biospectrumindia.com/news/95/6552/key-trends-in-pharma-sector-2015.html Wed, 16 Dec 2015 13:12:20 +0530 â€¢ The Uniform Code of Pharmaceuticals Marketing Practices (UCPMP), issued by the Department of Pharmaceuticals towards ethical marketing, came into effect in India from January 1, 2015. This is currently a voluntary code and extended till Jan 2016. Government may then consider making it a statutory code. This code will inspire great confidence among patients and demonstrate India's commitment to a high level of ethics and compliance. â€¢ Insurance bill was passed this year. This bill raised the foreign investment cap in insurance sector from 26 percent 49 percent. This measure was necessary for expanding the penetration of insurance in the country which is very low at present. â€¢ Government increased the coverage of price control on 8 new drugs to treat diabetes and hypertension. This was in addition to earlier 652 medicine packs based on 348 formulations of essential medicines controlled through DPCO. This will address the issue of affordability of essential medicine in the country. â€¢ Many Indian Pharma companies have come under the scanner of US FDA for manufacturing quality issues. Companies will have to address this challenge for a sustainable and compliant growth over next decade. â€¢ Industry has witnessed an increase in cross border deals like Lupin's acquisition of US based Gavis, Pfizer's acquisition of Allergan; these deals will have an impact in India. This trend will continue in the near term given the low valuation and the need for Indian companies to increase their scale to compete in the increasingly competitive generic markets, as well as increase their presence into the innovator side of the business. ]]> <![CDATA[Sanofi, Ingelheim enter exclusive negotiations on business swap]]> https://biospectrumindia.com/news/95/6969/sanofi-ingelheim-enter-exclusive-negotiations-on-business-swap.html https://biospectrumindia.com/news/95/6969/sanofi-ingelheim-enter-exclusive-negotiations-on-business-swap.html Wed, 16 Dec 2015 13:11:56 +0530 The proposed transaction would consist of an exchange of Sanofi animal health business (Merial) with an enterprise value of â‚¬11.4 bn and Boehringer Ingelheim consumer healthcare (CHC) business with an enterprise value of â‚¬6.7 bn. Boehringer Ingelheim CHC business in China would be excluded from the transaction. The transaction would also include a gross cash payment from Boehringer Ingelheim to Sanofi of â‚¬4.7 bn. The transaction would allow Sanofi to become the number one ranked player in CHC with expected pro forma sales of approximately â‚¬5.1 bn in 2015(e) and a global market share close to 4.6%. Sales of Boehringer Ingelheim CHC business (excluding China) are estimated at about â‚¬1.6 bn for 2015 and are highly complementary with those of Sanofi CHC, both in terms of products and geographies. Boehringer Ingelheim CHC would improve the position of Sanofi in Germany and Japan where Sanofi CHC presence is limited, and expand Sanofi presence in its Priority Categories. Sanofi would gain access to iconic brands in Antispasmodics, Gastrointestinal, VMS and Analgesics, and attain critical mass in Cough & Cold. Sanofi CHC business in the US, Europe, Latin America and Eurasia would also expand significantly, giving it multiple leadership positions in key countries and/or on key product categories. The animal health industry is a very attractive industry in terms of innovation, growth potential and profitability. Combining Merial's and Boehringer Ingelheim's complementary strengths would create the second largest player in the global animal health market with pro forma sales of approximately â‚¬ 3.8 bn in 2015(e) with the ability to compete for global market leadership. The combined portfolios and technology platforms in anti-parasitics, vaccines and pharmaceutical specialties would place the combined company in the key growth segments of the industry. The species portfolios are highly complementary building on Merial's expertise in companion animals and poultry and BI's expertise in swine. "In entering into exclusive negotiations with Boehringer Ingelheim, we have acted swiftly to meet one of the key strategic objectives of our roadmap 2020, namely to build competitive positions in areas where we can achieve leadership. This transaction would allow Sanofi to become a world leader in the attractive non-prescription medicines market and would bring a complementary portfolio with highly recognized brands, allowing for mid and long term value creation," said Dr Olivier Brandicourt, CEO, Sanofi. "I am confident that Boehringer Ingelheim will enable Merial to fully express and develop its potential in the attractive but competitive animal health market." Germany would become a key center of Sanofi CHC business, including in particular for Gastro-Intestinal and Cough & Cold categories that will benefit from the strong capabilities of Boehringer Ingelheim teams. Sanofi will pay particular attention to social matters as well as skills and people retention sensitivities. "Boehringer Ingelheim's strategic priority is to focus on the company's core areas of expertise and businesses with an established global scale, or where a pathway to a global scale can be achieved and prioritized among Boehringer Ingelheim's portfolio opportunities," said Prof Dr Andreas Barner, Chairman of the Board, Boehringer Ingelheim. "Boehringer Ingelheim Animal Health is and will stay strongly committed to bringing novel, innovation driven solutions to veterinarians and animal owners. Our combined Animal Health business would be well positioned for growth and emergence as a leader globally. I am confident that Sanofi will enable our CHC business to fully live its potential supported by highly professional and committed teams." Lyon would be a key operational center of Boehringer Ingelheim's Animal Health business. Boehringer Ingelheim will commit to maintain business operations, R&D and Manufacturing Centers in France. As the US market is an important part of Merial's business, Boehringer Ingelheim would pay particular attention to sustain the momentum of the US operations. Boehringer Ingelheim will give particular attention to social matters as well as skills and retention sensitivities. The execution of definitive agreements is expected in the coming months following consultations with the relevant social bodies. Boehringer Ingelheim and Sanofi's goal currently is to close the potential transaction in Q4 2016, subject to appropriate regulatory approvals. Sanofi intends to use a portion of the net proceeds of the transaction to repurchase shares. Taking into account the anticipated CHC results, share buybacks and potential synergies, the overall transaction is expected to be business EPS neutral in 2017 and accretive in subsequent years. ]]> <![CDATA[Pharmaceutical deals crucial to offsetting $2.5 bn cost of developing a novel drug]]> https://biospectrumindia.com/features/95/3672/pharmaceutical-deals-crucial-to-offsetting-2-5-bn-cost-of-developing-a-novel-drug.html https://biospectrumindia.com/features/95/3672/pharmaceutical-deals-crucial-to-offsetting-2-5-bn-cost-of-developing-a-novel-drug.html Wed, 16 Dec 2015 13:11:09 +0530 With the average cost of getting a novel drug to market at almost $2.5 billion, and few products achieving blockbuster status, deal-making is becoming increasingly vital for pharmaceutical companies to offset rising Research and Development (R&D) costs, says business intelligence provider GBI Research. The company's latest CBR Pharma report states that pharmaceutical companies are considering various strategies to overcome the current challenges, which also include shifts in patent laws and the struggling global economy, with deal-making the foremost method of boosting short-term revenues. Mr Priyatham Salimadugu, analyst for GBI Research, says deal activity can help pharma firms to enhance their research and regulatory approaches, and can aid portfolio expansion and diversification, geographic expansion, entry into niche markets, commercialization, and sales. He explains: "Small companies that primarily carry out research, development and production activities are looking towards entering into agreements with key industry leaders. They are seeking to utilize their strengths in terms of commercialization expertise and global presence in order to boost their revenues. "Meanwhile, big pharma corporations keen to secure novel and promising molecules are willing to co-operate with small players to expand their portfolios and reduce R&D risks." The analyst adds that the shift from small molecules to large molecules, such as antibodies and proteins, has created new opportunities in the pharmaceutical industry, leading to increasing deal numbers. GBI Research's report also states that overall pharmaceutical deal values remained between $110 billion and $160 billion from 2010 to 2014, but will rise markedly this year, with a total value of $261 billion already amassed by the end of July 2015, and further increased by more recent deals. Mr Salimadugu continues: "Deal volume and value have so far increased in 2015 compared with 2014. This creates a pyramid whereby more companies are developing drug molecules at the bottom of the pyramid, than commercializing them at the top, as typified by Pfizer's recent $160 billion takeover of Allergan. "Partnerships were the most popular type of deal between January 2014 and July 2015, followed by licensing deals and acquisitions. Though acquisitions were fewer, the disclosed deal value for this category was the highest." ]]> <![CDATA[DCGI nod for Natco's hepatitis C drug]]> https://biospectrumindia.com/news/95/6987/dcgi-nod-for-natcos-hepatitis-c-drug.html https://biospectrumindia.com/news/95/6987/dcgi-nod-for-natcos-hepatitis-c-drug.html Wed, 16 Dec 2015 13:10:12 +0530 Natco Pharma has announced that it has received approval for the generic version of ledipasvir+sofosbuvir combination from Drugs Controller General of India (DCGI). NATCO plans to launch this combination drug immediately, under its brand name Hepcinat LP, and through its strategic partners in India. Ledipasvir+Sofosbuvir is a two-drug fixed-dose combination product that contains 90 mg of ledipasvir and 400 mg of sofosbuvir in a single tablet, and sold globally by Gilead Sciences, under its brand HARVONI. It is indicated for the treatment of chronic hepatitis C (CHC) genotype 1 infection in adults. This single-tablet regimen is the first of its kind to offer significantly higher cure rates in Genotype-1 CHC infection compared to conventional therapies. NATCO will price its generic medicine, Hepcinat LP, at an MRP of Rs 25,000/- for a bottle of 28 tablets. NATCO was the first licensed company to launch the generic version of this combination drug earlier in Nepal. NATCO had signed a non-exclusive licensing agreement with Gilead Sciences earlier in 2015, to manufacture and sell generic versions of its chronic hepatitis C medicines, including generic version of HARVONI, in 100 other developing countries in addition to India. ]]> <![CDATA[Medicinal preparations dominate industry-academia collaborations in India: Thomson Report]]> https://biospectrumindia.com/news/95/7970/medicinal-preparations-dominate-industry-academia-collaborations-in-india-thomson-report.html https://biospectrumindia.com/news/95/7970/medicinal-preparations-dominate-industry-academia-collaborations-in-india-thomson-report.html Wed, 16 Dec 2015 10:41:30 +0530 The 2015 India Innovation Report by Thomson Reuters has outlined trends in innovation in Indian industry, academia and government based on patent publishing activity. It also revealed that corporations continue to drive innovation; academia and government contribute around 20 percent to the total patent activity in India. Apart from the findings of the report that were revealed on December 15, 2015 at New Delhi, the 2015 Thomson Reuters India Innovation Awards along with Top 50 Indian innovators were also announced. The awards honour the most innovative academic institutions and commercial enterprises headquartered in India for their spirit of innovation in R&D as it relates to Indian patent publications. Among six award winners, under the 'Corporate Pharma' category, Lupin and Cadila Healthcare have been awarded while under 'Academic and Government' the Indian Council of Agricultural Research received the honor. While launching the report, Mr Arvind Pachhapur, South Asia Head of IP and Science and Legal Business, Thomson Reuters, mentioned, "Globally, innovation is recognized by governments and corporations alike as the fundamental driver of economic and business growth. In India, however, the links between innovation in industry, academia and government is still in a nascent stage," adding, "for enhanced collaboration between corporate, academia and government, a deeper understanding of the technology landscape and convergence of the respective focus areas is critical." This is the first year when, in addition to analyzing the overall environment of innovation in India, the report also evaluates a growing momentum in the collaboration between each of these three segments. The analysis provides authoritative insights on the innovation landscape in India and recommendations to enhance collaboration between industry and academia. Sharing his observations on the growing collaborative innovation ecosystem, Dr. R. Chidambaram, Principal Scientific Advisor to Government of India, said, "The key components of an excellent research and innovation ecosystem are talent, the high quality of faculty, adequate funding, strong infrastructure, an appetite for risk taking and collaboration in research." The analysis shows that innovation in India, as measured by the number of patents, has been rising. The innovation volume is driven strongly by industry (government and private corporations) and the presence of research and development (R&D) centers of various multinational corporations in India. In line with the Honorable Prime Minister Narendra Modi's vision to transform India into a global manufacturing and innovation hub, the analysis acknowledges the significance of collaboration between industry, academia and government for innovation. Here are some of the report's key findings: â€¢ Innovation collaboration between Corporate-Academia-Government is still in nascent stages (0.4 percent in patenting, 0.6 percent in publishing). Front runners in patenting collaboration are Tata Steel, TCS, FDC, TVS from Corporate Segment; IIT-Bombay, IISc, IIT-Delhi, IIT-Madras, Panjab University and ISI from Academia segment and CSIR topping the chart from government segment. â€¢ A major proportion of the top ten is occupied by the IT/Software and Electrical industry. Tata Consultancy Services (TCS) tops the list followed by Samsung India Software operations and Bharat Heavy Electricals (BHEL) - the only central public sector enterprise to feature in the top 10 Corporate segment list. â€¢ Council of Scientific and Industrial Research (CSIR) leads with almost half the total volume of patents published in the top ten list of the Academia and Government segment followed by Defence Research and Development Organization (DRDO) and Amity University. â€¢ The top five technology focus areas for both the Corporate and Academia and Government segment differ but not entirely. Digital data processing and digital data transmission feature only in the top five for corporate and micro-organism composition and food treatment feature only in the top five focus areas of the Academia and Government. â€¢ Preparations for medicinal purposes are the key technology focus area for both the Corporate and Academia and Government segment but a deep dive within this shows slightly different focus - Preparation of herbal medicines by Academia and Government and preparation of organic active ingredients by corporations. â€¢ Corporate funding of academic research has been on the rise both in India and globally as measured by number of scientific papers funded by corporations. The compilation of data in the report was done using Thomson Innovation, Derwent World Patents Index (DWPI), Derwent Patent Citations Index (PCI), Thomson Data Analyzer and Web of Science. ]]> <![CDATA[Hottest Indian Start-up: Eradicating Measles from the world]]> https://biospectrumindia.com/features/95/5146/hottest-indian-start-up-eradicating-measles-from-the-world.html https://biospectrumindia.com/features/95/5146/hottest-indian-start-up-eradicating-measles-from-the-world.html Tue, 15 Dec 2015 17:41:00 +0530 Gone are the days when start-ups were associated with young-blooded, fresh graduates from prestigious universities abroad and iconic Indian institutes. Today, age is proving to be an ignorable factor for pursuing passionate entrepreneurial adventures. Fifty-two-year-old Dr Vishwas Joshi founded Pune-based start-up Seagull BioSolutions (SBPL) along with Dr Shailendra Maheshwari in 2011. The company is incubated at Venture Center, an Entrepreneurship Development Center, hosted by National Chemical Laboratory (NCL), Pune. Seagull is involved in developing and commercializing new technologies for advanced healthcare applications and medicines addressing unmet medical needs in the country and are affordable to the common man. Dr Joshi holds a PhD in Molecular Virology from Indian Institute of Science (IISc), Bangalore, and has extensively worked in the biopharmaceutical discovery research in leading companies including Ranbaxy, DRL, and Glenmark. Dr Shailendra Maheshwari has a medical degree coupled with a MD in Radiology from B J Medical College, Pune, and later was a resident fellow at the University of North Carolina, USA. Dr Maheshwari is currently a practicing Radiologist at the Hinduja Hospital, Mumbai, whose interest majorly falls into imaging cellular therapies. Innovative Technology Platforms Seagull has developed 2 technology platforms for producing protein and viral therapies and vaccines: eSAME and Active Virosome Technology. The former is useful for expressing recombinant proteins and RNA products in different animal cells. The latter helpful in producing new viral vaccines and gene therapy agents. Both these technologies are proprietary to Seagull, and allow development of biosimilar versions of existing therapies and vaccines, and also produce innovative therapies and vaccines belonging to emerging therapeutic classes. "Thus, they can be called as 'futuristic technologies'", says Dr Joshi.Seagull has already tied-up with a US-based biotech company for using the eSAME technology to deliver anti-sense RNA molecules into the cancer cells. If successful, this will be a more preferred method, since unlike the currently used systems, the eSAME system will not involve integration of the DNA into host cell genomic DNA. Novel Products Using both these platforms, the start-up has developed 3 novel products: SBPL-0100, SBPL-0200, and SBPL-0500. SBPL-0100 is an innovative oncolytic virotherapy which also induces anti-cancer immunity. This therapy will be effective against breast, lung and prostate cancers and represents a fast follower of US-based drug maker Amgen's T-Vec, which has opened a new class of non-toxic anti-cancer immunotherapies. SBPL-0200 is another innovative vaccine agent for Dengue prevention. "This is our first product produced using the Active Virosome Platform. The efficacy of the product was shown by in-house testing, and also confirmed by testing at the Center for Vaccine Development at Mahidol University (MU) in Thailand," reveals Dr Joshi. The third product, SBPL-0500 -- according to him -- is the world's first Virus Like Particles (VLP) vaccine for Measles. This vaccine is expected to be useful for immunizing infants aged between 4 to 9 months, who cannot be vaccinated with currently used vaccine, and still remain susceptible to measles infection and mortality. "If successful, this will help us get closer to the dream of eradicating Measles from the world altogether," voices Dr Joshi optimistically. The Dengue vaccine and the cancer therapeutic agent will be developed further up to Phase II clinical studies, and the products are planned to be out-licensed to interested biopharmaceutical companies at an appropriate stage. He adds, "This development will also provide an increased validation to our technology platforms, and establish their acceptability as a tool for producing new therapies and vaccines from regulatory point of view." Simultaneously, the company will also initiate Contract Research Services (CRS) to both academia and the industry to produce new Active Virosome Vaccines for other viral diseases like Chikungunya, Japanese Encephalitis (JE), other flaviviral diseases, Ebola virus, MERS (Middle East Respiratory Syndrome) and SARS (Severe Acute Respiratory Syndrome) among others. "In a brief span of 4 years, we established 2 technology platforms useful for producing new viral vaccines and therapeutic agents, and 3 innovative healthcare products which addresses critical unmet medical needs of common man in India and other developing countries," admits Dr Joshi. Funds Galore The company intends to expand further, probably in Europe, to begin with. "All our clients are expected to be in the West. So we are thinking of establishing a subsidiary in Europe. This will provide us with a greater visibility and access to our clients, and at the same time will provide access to knowledge-base which is currently lacking in India," he states. Its main clientÃ¨le includes companies in the anti-cancer drug discovery & immunotherapies, new vaccine development, and organizations involved in intracellular delivery of RNA molecules. The start-up plans to achieve revenues of $0.3 million in 2016 and increase it to well over $4 million. Seagull was bootstrapped for the first two years with an investment of Rs 3 crore. It then received its seed funding from the Indian Government's Technology Development Board (TDB) through the Entrepreneurship Development Center. Subsequently it went on to win funding support in the form of grants from DSIR (TePP--phase I), & DBT (BIG); Bill & Melinda Gates Foundation, USA; and ICICI Bank, India. "Several organizations like the Gates Foundation are currently working to solve problems in Life Sciences industry. Seeking funds from these organizations will be the most fruitful. Although bootstrapping cannot be eliminated altogether," he opines. He points that, in Biotechnology, VC investments are very poor in India. "Many VCs claim to be ready to invest in biotech initiatives, but few actually invest. Justifiable reasons support this reluctance to invest. But then, the VCs have to develop mechanisms to overcome the problems they face. This is taking too long a time," he expresses. IPs, Visibility At the moment, the company is in discussion with 2 European companies for collaborative interaction to study the complementarity of Seagull's technologies with the technologies of these other companies and evolve applications using such complementary technologies. "These collaborations will help generate shared IP with the collaborators, thus establishing a source for long-term revenues for the company," Dr Joshi notes. Seagull has now started publishing its activities more actively. It has presented its work on cancer therapy at the Oncolytic Viruses meeting in Boston, USA, held in June 2015, and expects to make similar presentations at upcoming conferences in the field of immunotherapies and vaccines. "Two research papers describing our products are currently being prepared and we expect them to be published soon. This will provide a very important publicity to Seagull. Additionally, we are seeking investments from interested parties so that a dedicated business development workforce can be established to actively connect with different clients and explore the available commercial opportunities," observes Dr Joshi. Start-up Revolution Dr Joshi thinks that Seagull managed to progress to its present stage only because of the active and ongoing initiatives of the Indian Government. "However, there is still a lot which the Government can do to help start-ups. The Government has established excellent programs for a start-up revolution. But there is now a need to develop means for helping start-ups grow and accelerate this start-up revolution. It needs to play a catalyzing role in this process. It could incentivize bigger companies to work on R&D programs with smaller start-ups. Alternatively, it may be able to bring in some of its PPP programs to big pharma companies to collaborate with start-ups. Such approaches will not only reduce the burden of financing, but may also help generate confidence about start-ups in bigger companies," he explains. He further says that an important drawback of India is that very often the Government of India fights a lonely battle in promoting and nurturing good innovative entrepreneurs and start-ups. "If the bigger pharma companies are induced to participate in this process, it will reduce the financial burden on the Government; provide industry specific selection pressure to this evolving start-up landscape; and create a more supportive ecosystem for start-ups," he justifies. "....Our government needs to modify its current policies providing tax incentives to big pharma companies based on merits, productivity and impact of the R&D undertaken." As for myths about Biotech start-ups, he says, "The words 'high-risk' and 'uncertainty' are widely abused by many researchers." He positively concludes by saying," Every successful start-up is a billion-dollar company - even if it doesn't make that many dollars." Milestones: 1. Recipient of DBT grant under the first round of BIG initiative2. Recipient of GCE 10th round grant award3. Winner of the gold medal (3rd place) in DST-Lockheed Martin India Innovation Growth program 4. Selected by Government of Belgium to participate in AWEX 2015 ]]> <![CDATA[Baseless opposition to GM Mustard: ABLE-AG]]> https://biospectrumindia.com/news/95/8243/baseless-opposition-to-gm-mustard-able-ag.html https://biospectrumindia.com/news/95/8243/baseless-opposition-to-gm-mustard-able-ag.html Tue, 15 Dec 2015 16:10:00 +0530 As per Dr Shivendra Bajaj, executive director, Association of Biotech Led Enterprises- Agriculture Focus Group (ABLE-AG), "GM Mustard has been submitted for approval to the apex review committee, Genetic Engineering Appraisal Committee (GEAC) after extensive research and trials which has been ongoing since the last 16 years, under the leadership of the renowned scientist of Delhi University, Dr Deepak Pental, and funded by Department of Biotechnology (DBT) and National Dairy Development Board's (NDDB). "The protest by some of these ill-informed groups implies that they do not even want a scientific review of the research. All we are saying is that let GEAC make a decision. Protesting against a technology without letting the regulators review the efficacy and safety is not right. In any case, we would like to highlight that genetically modified food has been consumed for over two decades across the world and not even a single case of adverse effect has been reported," added Dr Bajaj. Safety angle On the question of safety, Dr Bajaj mentioned, "In India, the cotton seed oil from Bt cotton has been used for cooking, for several years. The whole world including us consumes soybean and Canola oil, most of which is derived from GM plants, without any objection. Then why this sudden protest about a technology that has been developed by an eminent scientist of global repute, who has dedicated most of his life in mustard improvement." Yield benefit From the yield perspective, Dr Bajaj elaborated, "GM Mustard hybrid has the potential of increasing yield by 25 per cent. There is a growing need for GM Mustard in the country. Last year, India imported around Rs. 65,000 crores of edible oils to meet its consumption requirements. With increase in the population and per capita incomes, this deficit will only increase and can be met only through higher productivity of oilseed crops. Dr Pental's group has carried out very extensive work on quality traits and disease resistance. Once the technology is deregulated, quality hybrids and more productive hybrids with disease resistance will be readily possible." Science getting affected? We want to again highlight that GM mustard is developed in India with financial support from Indian sectors. In fact, this protest may be helping economies of other countries from whom we will keep on importing soybean and Canola oil, which by the way is extracted from GM plants. Even in India, we consume several confectionary items that are imported and may contain products that originated from GM Corn or Soybean. It is high time we realise that when the world has moved far ahead with adoption of advanced technologies, we in India are still stuck at a trial approval stage. This situation will affect our scientific community, the educational system as well as the future generation, to a very great extent. Why would eminent scientists, budding ones in the field of agri biotechnology and students who want to pursue a career in agribiotech, offered by various agri institutes want to invest their time and effort if science is not going to be given a fair chance in our country? Making the concluding statement, the ABLE-AG executive director voiced support for GM Mustard. "This is a request to individuals as well as government bodies who believe in scientific knowledge to take the decision of approving GM Mustard basis science and facts and not the myths or irrelevant information created by activists," said Dr Bajaj. ]]> <![CDATA[Hetero receives approval for Daclatasvir's generic version]]> https://biospectrumindia.com/news/95/4420/hetero-receives-approval-for-daclatasvirs-generic-version.html https://biospectrumindia.com/news/95/4420/hetero-receives-approval-for-daclatasvirs-generic-version.html Tue, 15 Dec 2015 14:02:57 +0530 Hetero, one of India's leading generic pharmaceutical companies and one of the world's largest producer of anti-retroviral drugs, today announced that it has received the approval from Drug Controller General of India (DCGI) for the generic version of Daclatasvir tablets (30mg, 60mg). The product in combination with Sofosbuvir is indicated for the treatment of Hepatitis C genotype 3 infections, which is highly prevalent in India. This product is a generic version of Bristol-Myers Squibb's brand 'Daklinza' - approved by USFDA in July 2015. Daclatasvir is one of the direct-acting antivirals for hepatitis C treatment. Research studies indicates that this drug enables the rapid decline of Hepatitis C virus. ]]> <![CDATA[FDA approves Roche's new lung cancer drug]]> https://biospectrumindia.com/news/95/5064/fda-approves-roches-new-lung-cancer-drug.html https://biospectrumindia.com/news/95/5064/fda-approves-roches-new-lung-cancer-drug.html Tue, 15 Dec 2015 11:04:30 +0530 Roche has announced that the US Food and Drug Administration (FDA) granted accelerated approval to Alecensa (alectinib) for the treatment of people with anaplastic lymphoma kinase (ALK)-positive, metastatic non-small cell lung cancer (NSCLC) who have progressed on or are intolerant to crizotinib. In the pivotal studies, Alecensa shrank tumours in up to 44 percent of people with ALK-positive NSCLC who progressed on crizotinib (objective response rate [ORR] of 38 percent [95 percent CI 28-49] and 44 percent [95 percent CI 36-53]). In a subset of people with tumours that spread to the brain or other parts of the central nervous system (CNS), Alecensa shrank CNS tumours in about 60 percent of people (CNS ORR of 61 percent [95 percent CI 46-74]). "Alecensa is now approved as a new option for people with ALK-positive NSCLC who progress on or are intolerant to crizotinib," said Dr Sandra Horning, chief medical officer and head of global product development. "Sixty percent of people enrolled in our studies had tumours that had spread to their central nervous systems, and Alecensa shrank tumours in many people in a subset of patients with CNS disease." Possible serious side effects with Alecensa include liver problems, lung problems, slow heartbeat, muscle pain, tenderness and weakness. The most common side effects of Alecensa include tiredness, constipation and swelling in the hands, feet, ankles and eyelids. The FDA's Accelerated Approval Program allows conditional approval of a medicine that fills an unmet medical need for a serious condition based on early evidence suggesting clinical benefit. The indication for Alecensa is approved under accelerated approval based on tumour response rate and duration of response (DOR). Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. In addition, Alecensa is being studied for use as an initial (first-line) treatment for people with advanced ALK-positive NSCLC. ALEX is a global, randomised phase III study comparing Alecensa to crizotinib as an initial treatment for people with advanced NSCLC whose tumours were characterized as ALK-positive by a companion VENTANA ALK (D5F3) CDx Assay immunohistochemistry (IHC) test developed by Roche Diagnostics. This study is part of the company's commitment to convert the current accelerated approval in people with ALK-positive, metastatic NSCLC who have progressed on or are intolerant to crizotinib to a full approval as an initial treatment. ]]> <![CDATA['7,400 newborns die every day in South-East Asia']]> https://biospectrumindia.com/news/95/7911/7400-newborns-die-every-day-in-south-east-asia.html https://biospectrumindia.com/news/95/7911/7400-newborns-die-every-day-in-south-east-asia.html Tue, 15 Dec 2015 11:04:00 +0530 Nearly 7,400 newborns die every day in South-East Asia, causing untold misery to mothers and families, yet two thirds can be saved with proven cost-effective measures, the United Nations health agency said, calling on Governments to act urgently against a scourge that kills 2.7 million newborns annually. "Scaling up interventions with good quality care around the time of childbirth and during the first days after birth can substantially prevent complications and infections in new-borns, which are the main causes of new-born deaths," UN World Health Organization (WHO) South-East Asia regional director Dr Poonam Khetrapal Singh stressed in Delhi, as health partners signed a pledge to reduce such deaths. The pledge calls for increasing the health workforce - doctors, nurses and specially midwives - which remains critically low in much of the region, below WHO's target of 23 per 10,000 people, as well as mobilizing sufficient funding and accessing hitherto unreached populations. The UN Children's Fund (UNICEF), UN Population Fund (UNFPA), World Bank, Joint UN Programme on HIV/AIDS (UNAIDS) and UN Entity for Gender Equality and the Empowerment of Women (UN Women), led by WHO, pledged to jointly support the accelerated reduction in newborn deaths by ensuring equitable access to life-saving interventions for mothers and babies. Dr Khetrapal Singh said each preventable death should be accounted for. Countries should review maternal and newborn deaths to improve health services to prevent such deaths. New-born deaths account for more than 50 percent of the regional mortality of children under five, and remain a major factor for South-East Asia not achieving the Millennium Development Goal (MDG) of reducing under-five deaths by two thirds by the end of this year. The region accounts for 30 per cent of global newborn deaths with Bangladesh, India, Indonesia, Myanmar and Nepal as the high-burden countries.The agencies pledged to address underlying factors like health, nutrition, hygiene and sanitation, and highlighted the importance of investing more in early childhood development and adolescent health. Dr Khetrapal Singh noted that the region made significant progress in reducing under-five deaths, which dropped by 64 per cent from 118 per 1,000 live births in 1990 to 43 per 1,000 in 2015, but reduction in new-born deaths was slower at 55 per cent, from 53 per 1,000 to 34 per 1,000.WHO has set up a Technical Advisory Group of 12 eminent global and regional experts to support countries in South-East Asia. The newly adopted Sustainable Development Goals seek to reduce new-born mortality to 12 per 1,000 live births by 2030. ]]> <![CDATA[US based Hysun Inc forays into India market]]> https://biospectrumindia.com/news/95/5968/us-based-hysun-inc-forays-into-india-market.html https://biospectrumindia.com/news/95/5968/us-based-hysun-inc-forays-into-india-market.html Tue, 15 Dec 2015 10:15:00 +0530 Hysun Inc. USA based biotechnology company specializing in the production of health supplements that improves microcirculation of the body has made its debut in the Indian market with the launch of its revolutionary diabetic supplement, "Suga Balanz" to tackle root cause of diabetes. In India, the company has joined hands with one of the country's biotechnology company, Phyto Biotech to manufacture and sell the product with an initial capacity of 1M bottles. Both the partners jointly plan to invest 15 million USD in the initial phase. The companies are expected to launch more than 10 products in the coming year. Speaking at the occasion, Dr Samuel Yue, founder, Hy-sun Biomedical Inc, said, "We are delighted to bring Suga Balanz to India. With the launch of our maiden product, we look forward to make a significant contribution to the growing healthcare industry in India. We see huge market potential here, given the large number of diabetic & pre-diabetic people in the country. We believe that diabetes can be better managed if we address the root cause of the problem, which our product Suga Balanz has successfully done for a number of patients globally." CirQ-Life, the brand of Hy-sun Biomedical, was awarded Mediazone's most valuable companies in Hong Kong for this year. "As part of our mission, we intend to offer best quality products at affordable prices to our consumers in the sub-continent. We constantly strive to transform and better the lives of our customers suffering from chronic diseases like diabetes, blood pressure, heart disease, joint pain & many more through innovative health supplements backed by cutting edge R&D. The launch of our first product "Suga Balanz" in India represents an exciting first step and we are confident that we will receive a positive response from this important market," he further added. Mr Karan Kakkad, director-marketing, Phyto Biotech, said "We are excited to join hands with Hysun Inc & manufacture high quality health supplements under Make in India policy. Suga Balanz which was being manufactured only in US, will now be manufactured in India also. The manufactured product will be made available in India and will also be exported to global markets. The lower manufacturing cost will make it more viable for some of the global price sensitive market. ". "Suga Balanz targets and decreases the insulin resistance i.e. makes insulin receptors more sensitive to insulin at cellular level among many of its functions. Many of the Indian diabetic patients have used Suga Balanz and have controlled their blood glucose extremely well & naturally" Mr Kakkad further added. According to Mr K K Singhania, one of the Suga Balanz users, ''I have been suffering from an elevated Sugar levels since last 18 years and been taking 56 units of insulin every day, 32 units in the morning and 24 units in the evening. After I started taking Suga Balanz, my fasting glucose started stabilizing to normal & gradually I could stop all my insulin injections. I am now taking Suga Balanz from quite sometime now & my Sugar levels & HbA1C are now under complete control. To me Suga Balanz is one of the best diabetes management supplement''. ]]> <![CDATA[Need to take healthcare to next level: Dr Jitendra Singh]]> https://biospectrumindia.com/news/95/6965/need-to-take-healthcare-to-next-level-dr-jitendra-singh.html https://biospectrumindia.com/news/95/6965/need-to-take-healthcare-to-next-level-dr-jitendra-singh.html Mon, 14 Dec 2015 10:53:18 +0530 Speaking at the session on "Collaborating with Government in Achieving India's Health Goals" of CII Health Summit, Dr Jitendra Singh, minister of state for PMO, Public Grievances and Pensions, mentioned that the type of health interventions that are needed in North-eastern states like Mizoram, Meghalaya and Manipur are essentially different from those who live in North and Western part of India. The North Eastern States has higher incidence of head and neck malignancies. "We have to identify specialized doctors in these disciplines and train them to tackle the health challenges existing there", the Minister added. Dr Singh who is also the minister of state for development of North Eastern Region, called for evolving a blueprint for inter-ministerial consultations to take the healthcare in India to the next level and also mapping the challenges which are region specific. The minister also referred to higher incidence of life-style diseases in India such as diabetes which have to be tackled on a war footing. However, not many hospitals are equipped to treat the patients. Many have to travel long distances to get the right treatment. In this regard, he suggested strengthening the infrastructure with the primary health centres. Also, public private partnership can be sought to tackle the growing menace of non-communicable diseases. Referring to the lack of hospital beds in the country particularly in the rural areas, the Minister said that the time had come that we have to introspect the skewed distribution of healthcare infrastructure. Mentioning that all stakeholders should be actively involved in ensuring universal health, the Minister said that there are areas where private sector can contribute wholly on their own or in coordination with the Government. The Minister also called for enhancing the quality of medical education to equip the practitioners to handle the state of the art technology. "We are looking at revising the entire medical curriculum to make it relevant to the present time", he added. "'There has been a substantial improvement in geographical and financial access to healthcare. However, access to healthcare through virtual platforms is at nascent stage in India. To meet the sector's current and future challenges, healthcare systems would require innovative solutions like mHealth tools, wearables and social media. This will also help in data aggregation in the sector,' said Dr Rana Mehta, Leader -Healthcare, PwC India. 'Integrating data with healthcare delivery has immense potential to increase the effectiveness of healthcare delivery systems and generate insights for the sector, 'said Dr Mehta added. ]]> <![CDATA[ICON acquires PMG Research]]> https://biospectrumindia.com/news/95/7946/icon-acquires-pmg-research.html https://biospectrumindia.com/news/95/7946/icon-acquires-pmg-research.html Fri, 11 Dec 2015 10:05:00 +0530 ICON has announced the acquisition of PMG Research, an integrated network of clinical research sites operating from 12 metropolitan areas throughout the US. The acquisition will enhance ICON's ability to access and engage with investigator sites and patients, helping customers to reduce the overall time and cost associated with drug development. PMG Research is an integrated network of clinical research sites consisting of 48 physician practices and large multi-specialty healthcare institutions throughout North Carolina, South Carolina, Tennessee and Illinois. PMG Research conducts clinical trials in all major therapeutic areas with particular experience in cardiology, dermatology, endocrinology, gastroenterology, men's health, neurology, pulmonology, rheumatology, vaccine, and women's health trials. In addition to a proprietary research database of clinical trial participants, PMG Research also has access to over 2 million active patient lives via electronic health records through their unique partnerships with healthcare systems and community physician practices. Commenting on the acquisition, Mr Ciaran Murray, CEO, ICON, said, "Enrolling and engaging patients in clinical trials is a key challenge within drug development. Leveraging PMG Research's network, we will help customers to enhance clinical trial feasibility and improve patient enrolment timelines whilst also giving patients access to a broader range of care options through clinical trials. Today's acquisition, together with our work with IBM Watson on clinical trial matching, reflects our commitment to enhancing engagement with sites, patients and healthcare providers to take significant time and cost from our customers' development programmes." Ms Jennifer Byrne, CEO of PMG Research, said, "ICON shares PMG's progressive views and by combining together we can enhance our ability to scale our know-how, infrastructure, and health care relationships to bring more of the right trials to the right patients. Together we will enhance the execution of clinical trials and deliver greater value for both the industry and health care systems, forging better and closer connections. The ultimate beneficiary of this work will be patients through lower cost of care, improved clinical outcomes and enhanced patient experiences." ]]> <![CDATA[Dengvaxia, world's first dengue vaccine approved in Mexico]]> https://biospectrumindia.com/news/95/7004/dengvaxia-worlds-first-dengue-vaccine-approved-in-mexico.html https://biospectrumindia.com/news/95/7004/dengvaxia-worlds-first-dengue-vaccine-approved-in-mexico.html Fri, 11 Dec 2015 10:00:00 +0530 Sanofi Pasteur, the vaccines division of Sanofi, has announced that the Mexican authorities have granted marketing authorization to Dengvaxia, making it the first vaccine to be licensed in the world for the prevention of dengue. The Federal Commission for the Protection against Sanitary Risks (COFEPRIS) has approved Dengvaxia, tetravalent dengue vaccine, for the prevention of disease caused by all four dengue virus serotypes in preadolescents, adolescents and adults, 9 to 45 years of age living in endemic areas. "When Sanofi set out to develop a dengue vaccine 20 years ago together with local and global public health and scientific communities, it was with the intention of developing an innovative vaccine to tackle this global public health need," said Dr Olivier Brandicourt, CEO, Sanofi. "Today, with this first marketing authorization of Dengvaxia, we have achieved our goal of making dengue the next vaccine-preventable disease. This is a historic milestone for our company, for the global public health community and, most importantly, for half the world's population who lives at risk of dengue." The COFEPRIS approval of Dengvaxia is based on results from an extensive clinical development program involving over 40,000 people of different ages, geographic and epidemiological settings, and ethnic and socio-economic backgrounds living in 15 countries. Dengue-endemic regions of Mexico participated in all three phases of the clinical development program for the vaccine. Regulatory review processes for Dengvaxia are continuing in other endemic countries. Manufacturing of Dengvaxia has already started at vaccine facilities in France and first doses are already produced. Sanofi Pasteur remains committed to introducing Dengvaxia first in countries where dengue is a major public health priority. The World Health Organization (WHO) has called for development of a dengue vaccine as an essential part of the integrated dengue prevention effort needed to significantly lower the dengue burden globally. The WHO has called on endemic countries to reduce dengue mortality by 50 percent and morbidity by 25 percent by 2020. ]]> <![CDATA[Sun Pharma and partners to develop brain therapies]]> https://biospectrumindia.com/news/95/6916/sun-pharma-and-partners-to-develop-brain-therapies.html https://biospectrumindia.com/news/95/6916/sun-pharma-and-partners-to-develop-brain-therapies.html Fri, 11 Dec 2015 09:55:00 +0530 Sun Pharmaceutical has entered into a tripartite research and option agreement with Israel-based Weizmann Institute of Science and Spain's Health Research Institute of Santiago de Compostela (IDIS) to develop breakthrough products for the treatment of neurological diseases like brain stroke; as well as glioblastoma, a lethal brain cancer. Scientists at Weizmann Institute have developed a recombinant enzyme currently undergoing animal studies for indications of brain stroke and glioblastoma. Further studies of this enzyme will be conducted at the Health Research Institute of Santiago de Compostela in Spain. Moreover, this enzyme may potentially be indicated for uses beyond these two brain diseases. As per the signed triparty agreement, Sun Pharma will have the first right to develop these additional indications. Sun Pharma will have the exclusive option to conduct further development of the enzyme after completion of the preclinical studies. The company will have commercial rights to this product globally. It will also fund all future studies to be conducted on the enzyme. The tripartite research collaboration agreement has been signed between Sun Pharma, Yeda Research & Development Company (the commercial arm of the Weizmann Institute of Science), and Fundacion RamÃ³n DomÃnguez (on behalf of IDIS). Based on outcome of animal studies, Sun Pharma will have an option to exercise rights for further development and commercialization of the enzyme. Commenting on its collaboration with Weizmann Institute of Science and Health Research Institute of Santiago de Compostela, Mr Kirti Ganorkar, Sr. vice president, Sun Pharma said, "This collaboration is in line with our philosophy of putting patients first. We see our collaboration with world-renowned academic institutions like the Weizmann Institute of Science and the Health research Institute of Santiago de Compostela enabling new projects on breakthrough products to address current unmet medical needs. Such products will bring about a better quality of life for the patient by enabling doctors to make crucial decisions and offer immediate treatment in high risk medical emergencies. We are excited about this collaboration and envision that this will enrich our novel and highly specialized product portfolio." According to Prof. David Mirelman, The Weizmann Institute of Science "We are pleased to be a part of the tripartite research and development agreement with Sun Pharma. Our work is based on the original discoveries in the Weizmann Institute of the late Prof. Vivian Teichberg . Together with the researchers at the Health Research Institute of Santiago de Compostela, working under the direction of Prof. Jose Castillo, we hope to bring this work to maturation." IDIS believes this collaboration will contribute to developing strong bonds for delivering important benefit in biomedical research and patients. Prof. JosÃ© Castillo, director of Health Research Institute of Santiago de Compostela said, "IDIS supports translational research so that new findings can be used in clinical practice. The agreement with Sun Pharma and Weizmann Institute represents an important milestone for our Institution, since the studies carried out by the researchers of the Clinical Neuroscience Research Laboratory and Stroke Unit of the Neurology Department of our University Hospital are now closer to patients." He added, "The collaboration initiated with Prof. Vivian Teichberg and later continued with Prof. David Mirelman of the Weizmann Institute culminates through this new agreement. The development work collaborated through this agreement for treatment of neurological diseases like stroke, a leading cause of death and disability including loss of quality of life, can alleviate this epidemic in the 21st century. We also hope that this agreement contributes to bring new perspectives for the treatment of brain glioblastoma." ]]> <![CDATA[Sanofi sets out strategic roadmap for long-term growth ]]> https://biospectrumindia.com/news/95/8078/sanofi-sets-out-strategic-roadmap-for-long-term-growth-.html https://biospectrumindia.com/news/95/8078/sanofi-sets-out-strategic-roadmap-for-long-term-growth-.html Thu, 10 Dec 2015 13:51:27 +0530 As a result of investments in launches, headwinds in diabetes and the phasing of cost savings, Sanofi does not expect to show any meaningful bottom line growth over 2016-2017. Beginning in 2018, however Sanofi expects to grow Business EPS faster than sales, reflecting its improved sales mix and the full capture of cost efficiencies. "The pharmaceutical industry is undergoing a transformation unlike anything we've previously seen. Continued consolidation in the sector has created a more competitive environment over the last few years and, at the same time, science has never been more exciting. In this context, I am defining new priorities for Sanofi. The company will remain diversified, but with a portfolio refocused on areas where we can win, and innovation driven to improve lives of millions of people," said Dr Olivier Brandicourt, CEO, Sanofi. "Along with a more streamlined and accountable organization, we are taking clear measures to ensure success as we launch a strong set of new medicines across several therapeutic areas. By building on the successes of these products, we are confident that Sanofi will be well-positioned for sustained, long-term growth. Sanofi is also seeking external opportunities to enhance its growth profile." Sanofi's long-term strategy rests on four pillars: reshape the portfolio, deliver outstanding launches, sustain innovation in R&D and simplify the organization. Reshape the portfolio Sanofi's diversified portfolio will be reshaped in three different ways: Sustain leadership The company will sustain its leadership in diabetes and cardiovascular, vaccines, rare diseases and emerging markets. In diabetes, Sanofi plans to develop its insulin franchise, which includes Lantus, Toujeo and LixiLan, strengthen its pipeline through external opportunities (e.g. in-licensing agreements with Lexicon and Hanmi) and lead the market shift to managing diabetes outcomes. The collaboration with Google Life Sciences is a good example of the latter. In the cardiovascular space, Sanofi is excited about the prospects for Praluent and eagerly awaits the results of the ODYSSEY cardiovascular outcomes trial in 2016-2017 which should help to capture the drug's full potential. In the vaccines field, the objective is to grow faster than the market through the company's Dengvaxia, flu, pediatric and boosters vaccines. Lastly, in emerging markets, the company intends to retain its number one position through greater focus on priority countries. In those regions, resource allocation will be prioritized, the industrial footprint will be adapted and dedicated innovations will be specifically developed. Build competitive positions Sanofi will build competitive positions in multiple sclerosis, oncology, immunology and consumer healthcare. In oncology, Sanofi plans to rebuild a competitive position by regaining critical mass. In order to achieve this goal, the company intends to maximize clinical assets like isatuximab in multiple myeloma, and restore a competitive pipeline through its strategic collaboration with Regeneron in immuno-oncology. In immunology, sarilumab in rheumatoid arthritis and dupilumab in atopic dermatitis and asthma will be the two pillars of a new franchise. In consumer healthcare, Sanofi plans to build scale through new categories of products and bolt-on acquisitions. Explore strategic options Sanofi will explore strategic options for its animal health and European generics businesses. In animal health, Merial has successfully returned to strong growth over the past six quarters and is currently one of the most profitable companies in its sector. Nevertheless synergies are limited with other Sanofi businesses. Strategic options will also be explored for generics in Europe where geographic synergies are limited and market complexity is increasing. All options will be considered for these businesses including retention in the Group. Deliver outstanding launches Sanofi's growth will be notably driven by the launches that are scheduled for the next five years. Up to 18 new products are on track to arrive on the market by 2020. Among these, Sanofi projects that six key launches (Toujeo, Praluent, Dengvaxia, sarilumab, LixiLan and dupilumab) could generate aggregate peak sales of â‚¬12 bn to â‚¬14 bn by 2025. Sustain innovation in R&D Sanofi announced plans to continue to strengthen its R&D pipeline and evolve its R&D model based on project teams and alignment with its GBUs. The organization will also foster its existing R&D collaborations and increase its capacity for external innovation. At the meeting today, President of Global R&D Elias Zerhouni will provide an update on the next wave of promising pipeline assets. Simplify the organization As announced in July, Sanofi is in the process of simplifying its global organization. The move to five GBUs will start to be implemented beginning in January 2016 following mandatory labor consultations. In addition, Sanofi plans to reshape its plant network to match business evolution with increased emphasis on the growing biologics portfolio. Simplification of the organization worldwide and a more focused portfolio should allow cost savings of â‚¬1.5 bn by 2018, which will be largely reinvested to support growth initiatives. With the benefit of these cost savings, the Group gross margin and SG&A ratio to sales in 2018 are each expected to be similar to their respective 2015 levels at CER. Reflecting the company's ambition to drive long term growth, the R&D ratio to sales is expected to rise slightly over the period 2015-2020 at CER. By 2020, Sanofi plans to increase its total annual R&D investments up to â‚¬6 bn at CER while maintaining financial discipline. ]]> <![CDATA[Aurobindo receives FDA approval for Eptifibatide injection]]> https://biospectrumindia.com/news/95/7907/aurobindo-receives-fda-approval-for-eptifibatide-injection.html https://biospectrumindia.com/news/95/7907/aurobindo-receives-fda-approval-for-eptifibatide-injection.html Thu, 10 Dec 2015 12:00:43 +0530 Aurobindo Pharma has received final approval from the US Food & Drug Administration (US FDA) to manufacture and market Eptifibatide Injection USP, 20 mg/10 mL, 75 mg/100 mL, and 200 mg/100 mL single-use vials. This product is expected to be launched in this month. The approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) Integrilin Injection, 20 mg/10 mL, 75 mg/100 mL, and 200 mg/100 mL of Schering Corporation. The approved product has an estimated market size of $137 million for the twelve months ending October 2015 according to IMS. ]]> <![CDATA[India gets $500 mn from GAVI for immunization programme]]> https://biospectrumindia.com/news/95/6304/india-gets-500-mn-from-gavi-for-immunization-programme.html https://biospectrumindia.com/news/95/6304/india-gets-500-mn-from-gavi-for-immunization-programme.html Thu, 10 Dec 2015 11:59:51 +0530 Gavi, the vaccine alliance has committed to offer $500 million to the Indian government over the next five years for supporting immunization programme in the country, says reports. Created in 2000, Gavi is an international organisation - a global vaccine alliance, bringing together public and private sectors with the shared goal of creating equal access to new and underused vaccines for children living in the world's poorest countries. Additional Secretary, Health, Mr C K Mishra said that Gavi Board that monitors vaccine implementation programme will provide $500 million to support the government for next five years. "Gavi Board last week approved our proposal which was being doubted all over. According to the proposal, they will give $500 million over the next five years. The major vaccines we are looking forward to support with this amount are rotavirus, measles-rubella, PCV vaccine and also as when we decide to introduce HPV," he said in a statement. ]]> <![CDATA[New ministry for pharma & medical devices soon]]> https://biospectrumindia.com/news/95/3031/new-ministry-for-pharma-medical-devices-soon.html https://biospectrumindia.com/news/95/3031/new-ministry-for-pharma-medical-devices-soon.html Thu, 10 Dec 2015 10:24:15 +0530 Union Minister of Chemical and Fertilizers, Mr Ananth Kumar has ruled out, doing away with the price control on essential and life savings drugs, asserting that the Modi government is pro-poor though assured that industry will continue to be consulted. He also promised creation of separate ministry for pharma and medical devices within a span of a year as also commited execution of Katoch Committee recommendations in next 100 days that are likely to transform the pharma sector. He also said that the inverted duty structure on pharma & medical devices will be taken up personally by himself with the Finance Minister based on PHD Chamber's representation on the issue While inaugurating the 4th Annual Conference : PharmaMed 2015, organized by the PHD Chamber of Commerce and Industry on December 14, 2015, Mr. Kumar said, "the government will continue to control the regulated list of pharma products that currently number 603 though it might make revision in it to enable access, affordability and acceptability with quality, the pharma products to patients in far flung areas but will not loosen its control on essential and life savings pharma products in the interest of the common man". "Nowhere in the world, regulations and control on such essential sectors are in vogue and India cannot be an exception. I urge industry and pharma manufacturers of generic drugs to increase access, affordability and acceptability of their products with focus on quality so that patients do not suffer shortages of such products", said the Minister asserting that in next 100 days, the much talked about Katoch Committee recommendations will be implemented with due approval of the cabinet if so required. So far as the issue of new ministry, relating to pharma and medical devices is concerned, the government of the day would constitute it in next one year as preliminary exercises to this effect with all stakeholders including the Prime Minister's Office and the Prime Minister himself are on, informed the Minister. On the issue of inverted duty structure on the pharma and medical devices sector, Mr. Kumar promised industry that he along with his Minister of State would shortly seek consultations with the Finance Minister to settle this issue so that necessary disclosures for it are incorporated in the forthcoming budget. Minister of State of Chemicals and Fertilizers, Mr Hansraj Gangaram Ahir assured industry that the government of the day would make no intervention with pharma manufacturers, excepting urging them to make quality drugs as Indian generic drugs not only cater to domestic demands but also serve the export requirements for over 200 countries. Secretary, Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers, Dr V K Subburaj also said that all policy barriers that restrict the growth of pharma and medical device industry are being removed with provisions in new bulk drug policy which would be put in place in next few months in consultation with PMO. Vice President, PHD Chamber, Mr Anil Khaitan in his welcome remarks, demanded actions on policy front from all government bodies so that pharma manufacturing becomes an integral part of Make in India project of the Prime Minister. Chairman and Co-Chairman, Health Committee, PHD Chamber, Mr. Nishant V Berlia and Mr Himanshu Baid also demanded from the government the flexible policies so that growth is grown in the pharma and medical device sector. ]]> <![CDATA[Roche inks cancer pact with SQZ Biotech ]]> https://biospectrumindia.com/news/95/6908/roche-inks-cancer-pact-with-sqz-biotech-.html https://biospectrumindia.com/news/95/6908/roche-inks-cancer-pact-with-sqz-biotech-.html Wed, 09 Dec 2015 15:43:16 +0530 SQZ Biotech (SQZ) has announced a partnership with Roche to develop a cell therapy platform that would empower a patient's own immune cells to fight a broad range of cancers. The deal leverages SQZ's pioneering technology to engineer B cells as a therapeutic platform for oncology - a novel approach with the potential to overcome many of the shortcomings of current cell-based therapies. The agreement provides for over $500M in upfront and potential clinical, regulatory and sales milestone-based payments for advancement of all products across all planned indications, in addition to royalties on potential future products. "The therapeutic potential of SQZ technology builds on our ground breaking ability to engineer cell function through intracellular delivery - a long standing challenge in immunology," said Dr Armon Sharei, founder and chief executive officer of SQZ. "In collaboration with the renowned team at Roche, we seek to engineer a patient's own immune system to target tumors more effectively and bring hope to people suffering from cancer." The proposed therapy involves using SQZ technology to introduce proteins into a patient's B-cells which will then help activate killer T-cells to attack the cancer. The ability to engineer such a response is fundamentally dependent on effective delivery of tumor-associated proteins, or antigens, into the patient's B cells. This delivery process is uniquely enabled by SQZ's technology and harnesses the power of the patient's own immune system to fight tumors more effectively across a broad range of cancer types. Executive Chair of the SQZ Board Ms Amy Schulman said, "We are excited about this partnership because it capitalizes on the unique scientific platform that SQZ provides to engineer immune cell function. This is an important first step towards a new generation of cell based therapies." ]]> <![CDATA[NeoBiocon partners with Novartis to offer Vildagliptin for Diabetics in UAE]]> https://biospectrumindia.com/news/95/6915/neobiocon-partners-with-novartis-to-offer-vildagliptin-for-diabetics-in-uae.html https://biospectrumindia.com/news/95/6915/neobiocon-partners-with-novartis-to-offer-vildagliptin-for-diabetics-in-uae.html Wed, 09 Dec 2015 15:40:00 +0530 NeoBiocon, a collaboration between Biocon Ltd and Dr. B.R. Shetty, Chairman of the UAE-based Neopharma, announced today that it has partnered with Novartis Middle East FZE, to market Jalra (Vildagliptin) and Jalra-M (Vildagliptin + Metformin) in UAE. This partnership will help NeoBiocon expand its product offerings in the metabolics segment and will immensely benefit diabetics in UAE. Vildagliptin is an oral anti-diabetic agent that delivers consistent and robust blood sugar control in patients with type 2 diabetes. It is a class of dipeptidyl peptidase IV (DPP-IV) inhibitors, which does not cause weight gain and have low risks for hypoglycaemia. The overall market for oral hypoglycaemic agents (OHA) in UAE is estimated to be $115 million and DPP-IV inhibitors command nearly 50% share of this market. A novel product, Vildagliptin is available both as monotherapy as well as in combination with metformin. Together Vildagliptin and Vildagliptin + Metformin commands over 30% of the DPP-IV market in UAE. NeoBiocon has received approvals from the Ministry of Health-UAE for marketing Jalra and Jalra-M in the country and the launch is scheduled for Jan 2016. These products will be manufactured by Novartis in Europe and marketed and distributed by NeoBiocon in UAE after local release through Neopharma. Talking about the partnership, Dr. B. R. Shetty, Chairman, Neopharma, said: "We are delighted to extend our partnership with Novartis and Biocon for these novel products. Biocon's leadership in the diabetes segment will augur well for marketing these brands in UAE." Commenting on the development, Dr Kiran Mazumdar-Shaw, CMD, Biocon, said: "Biocon is committed to offer advanced therapies for diabetics the world over. We are indeed pleased to partner with Novartis to offer Jalra and Jalra-M to address the growing needs of type 2 diabetes patients in UAE." The partnership between NeoBiocon and Novartis will benefit the large and increasing number of diabetics in the UAE. This will result in enhancing access to this novel oral hypoglycaemic agent by leveraging the huge marketing network of NeoBiocon & distribution network of NMC Healthcare. Novartis will continue to market its brands Galvus & Galvusmet in the UAE. Mohamed Ezz Eldin, Country Pharmaceutical Organization Head (UAE), Novartis said: "Our mission is to improve patient lives, and help them lead a normal and healthy life. Novartis is a company with a mission: Delivering the right treatment to the right patient at the right time. Therefore, as part of our continuous efforts to maximize patient access to our medications, Novartis is partnering with NeoBiocon, which aims to help more Diabetic patients to gain access to innovative medications, in addition to supporting the local manufacturing and partnering with local companies. This could not have happened without the vision of the UAE Government, and the great support from the UAE Health Authorities, and MOH who continuously encourage investment, innovations and improving patient's lives." NeoBiocon is amongst the fastest growing pharmaceutical companies in UAE and is ranked amongst the top 25 pharma companies in the region. It is the no.1 generic pharma company in UAE, in the cardiovascular segment with successful brands like Statix (atorvastatin). Established in 2011, NeoBiocon markets its own brands in UAE & other GCC markets in various therapies such as metabolics, oncology, asthma & allergic rhinitis, anti-infectives and others. ]]> <![CDATA[Shortage of drug inspectors hurting pharma exports: Study]]> https://biospectrumindia.com/news/95/7070/shortage-of-drug-inspectors-hurting-pharma-exports-study.html https://biospectrumindia.com/news/95/7070/shortage-of-drug-inspectors-hurting-pharma-exports-study.html Wed, 09 Dec 2015 13:09:21 +0530 India has a meager number of 1,500 well equipped inspectors for more than 10,000 factories engaged in pharmaceutical products leading to the country's products facing regulatory hurdles in the overseas markets like the US which follow stringent protocols for the manufacturing processes, a sectoral study done by The Associated Chambers of Commerce of India (ASSOCHAM) and research firm RNCOS has pointed out. It said the Indian pharmaceutical sector which made rapid strides in the global markets, is now faced with several regulatory hurdles, especially in the US and EU, according to a study on 'Focus on Quality Management in Pharmaceutical Manufacturing,' jointly conducted by The Associated Chambers of Commerce and Industry of India (ASSOCHAM) and RNCOS. "While at times, the US Food and Drug Administration (FDA) gets into minute details which have more to do with the cumbersome procedure rather than quality, we need to get our own house in order by way of continuous skilling of the regulators at the national and state levels in sync with the best global practices. However much we may wish otherwise, the pharma sector is and will always remain one of the most regulated sectors all across the world for the sake of public health," ASSOCHAM Secretary General Mr D S Rawat said while releasing the study. The mismatch between the domestic regulatory mechanism and the international regime is resulting in recall and rejection of drugs made by even some of the well known companies, leading to unrest and frustration. In the long run, the pharmaceutical exports during the fiscal year 2013-14 reported US$ 14.8 billion of drug exports would take a setback. According to the study, India ranks 4th in pharmaceutical production in the world with a production output of about $31 Billion in 2014. The country has a 1.4% share by value and 10% by volume in the global pharma industry. India is one of the leaders in pharmaceutical exports. The domestic pharma market was valued at $15.4 Billion in 2014, and is expected to expand at a CAGR of 13.3% to $32.7 Billion by 2020. Driven by favourable demographics including growing aging population, increasing lifestyle diseases, steep growth in disposable incomes and increasing penetration of Indian drug players in the global market, India is likely to be among the top three pharmaceutical markets by incremental growth and sixth largest market globally in absolute size, noted study. The pharmaceutical manufacturing is managed by multiple regulatory authorities, which include the Central Regulatory Agency, the office of the DCGI (Drugs Controller General of India) under Central Drugs Standard Control Organization (CDSCO) with zonal offices and the State FDAs. This makes the process of obtaining license, for pharmaceutical product manufacturing complex. There are numerous patent offices in metro cities all over India. Each of these offices follows non-uniform patent practices. Thus, these varied practices and poor centralized controls affect the quality of the pharmaceutical products. The pharmaceutical industry in India has a concurrent regulatory practice, which is sometimes poorly manned and poorly headed by less knowledgeable pharmacists who are not properly trained. Lower awareness among such personnel regarding the quality norms leads to non-uniform implementation of regulatory standards. Small and Medium size manufacturers in the Indian pharmaceutical industry do not have the funds and the capacity to carry out the quality checks The government provides subsidies to only those pharmaceutical companies, which are present in special economic zones. Manufacturers which are not present in these zones are not able to avail these benefits, which they can use for the implementation of quality standards in their manufacturing sites. With the absence of global harmonization of quality systems makes it all the more challenging for India that exports to US, Europe, Australia, Japan, etc, to comply with a plethora of regulatory guidelines across the globe, said Mr Rawat. ]]> <![CDATA[Update on Dr Reddy's FDA warning letter]]> https://biospectrumindia.com/news/95/6954/update-on-dr-reddys-fda-warning-letter.html https://biospectrumindia.com/news/95/6954/update-on-dr-reddys-fda-warning-letter.html Wed, 09 Dec 2015 12:36:39 +0530 Dr Reddy's Laboratories (DRL) has submitted a response to the US Food and Drug Administration (US FDA) on December 7, 2015, the firm said in a filing to BSE. Dr Reddy's has received a warning letter issued by the US FDA on November 05, 2015 relating to its API manufacturing facilities at Srikakulam, Andhra Pradesh and Miryalaguda, Telangana, as well as Oncology Formulation manufacturing facility at Duvvada, Visakhapatnam, Andhra Pradesh. In response to the letter, Mr G V Prasad, CEO, DRL said, "We are in the process of shifting some of the products from these plants to other facilities and considering third party assessment for its plants." ]]> <![CDATA[West's NovaPure receives 2015 India Pharma Award]]> https://biospectrumindia.com/news/95/4922/wests-novapure-receives-2015-india-pharma-award.html https://biospectrumindia.com/news/95/4922/wests-novapure-receives-2015-india-pharma-award.html Wed, 09 Dec 2015 10:51:27 +0530 West Pharmaceutical Services has announced that it has received the 2015 India Pharma Award for Outstanding Primary Packaging for Injectables for its high-quality NovaPure components. Organized by UBM India, the India Pharma Awards recognize innovation and excellence by pharmaceutical companies and related stakeholders operating in India. The Outstanding Primary Packaging for Injectables award honors products and initiatives that have enhanced packaging to fortify product integrity and improve efficiency. West's NovaPure components were recognized for their exceptional quality, cleanliness and reliability. "We are honored to receive this award recognizing NovaPure components and West's ongoing commitment to quality," said Mr Alagu Subramaniam, country manager and director, West. "We work by the side of our pharmaceutical and biopharmaceutical customers to design and manufacture packaging and delivery systems that bring drugs from concept to the patient more efficiently, reliably and safely. NovaPure is a great example of this dedication." West opened its first manufacturing facility in India in 2014 in response to growing demand for high-quality drug packaging and delivery systems from customers in India and the broader Asia Pacific region. As industry guidance regarding particulate matter is becoming increasingly stringent, these customers are seeking cleaner, more consistent packaging components that minimize risk and variability. NovaPure components are created through a product development process that incorporates scientific Quality by Design (QbD) principles and puts the patient first. West's NovaPure offerings include serum and lyophilization stoppers and syringe plungers. These components help to mitigate the risks associated with particulates, including potential extractables and leachables, and help ensure that injectable drug products are safe for patients. Located in India's Sri City Special Economic Zone, West's manufacturing plant produces components and seals used in primary packaging of injectable medicines manufactured by West's pharmaceutical and biopharmaceutical customers throughout Asia. As production shifts to the India plant, West's Singapore facility will add high-value product production to meet the future demands of the growing Asia market. ]]> <![CDATA[Hottest new start-up: 'A roller-coaster ride for the first 999 days']]> https://biospectrumindia.com/features/95/6896/hottest-new-start-up-a-roller-coaster-ride-for-the-first-999-days.html https://biospectrumindia.com/features/95/6896/hottest-new-start-up-a-roller-coaster-ride-for-the-first-999-days.html Tue, 08 Dec 2015 16:52:00 +0530 Dreams Vs Destiny In 1995, he worked for the National Research Council of Canada, and then moved on to be the associate director & principal scientist for US-based Dyax Corp in 2001. While in North America for 20 years, he intended to start a drug discovery venture along with his colleagues. But things didn't work out as planned. He returned to his country in 2008 and worked for Bangalore-based Biocon as the chief scientific manager for the next 4 years. Post which, his good old entrepreneurial dreams began to take shape. After his stint with Biocon, the year 2012 marked the beginning for Affigenix Biosolutions, his Bangalore-based biotech start-up, offering innovative biosolutions to the Life Sciences industry, where he serves as its MD & CSO. He says that his inspiration directly trickled down from both his father and father-in-law. His father at 21 became the family's first entrepreneur in the early 70's by establishing a poly-woven sack manufacturing plant in the rural area. Though a high-school dropout, his father-in-law went on to establish a 4000-employee organization with footprint in almost every state in India. Innovative Biosolutions Affigenix's parent organization is the CREW (Chennai Radha Engineering Works) group of company, where its chairman Mr Sambandam Venkatesan, is known to be the investor and also the chairman of Affigenix. CREW is a leading company in bulk material handling system undertaking projects in thermal power plants and ports with an annual turnover of Rs 400 crore. CREW also owns Interlace India, a software company in Chennai. Dr Arumugam voices, "As soon as I decided to start the company I informed my family first and secured the initial funding from my father-in-law.... The company name was chosen by my children and the logo was designed by a friend. Before registering the company we legally secured the website address and logo. Although I did not have formal business plan, I vetted my ideas to my friends and family and then started to look for an incubator facility." In Aug 2014, the company received the DBT-BIRAC-BIG 3 seed funding worth Rs 45.2 lakh in installments through its BIG partner -- Centre for Cellular and Molecular Platforms (C-CAMP). Affigenix's R&D facility in Bangalore is equipped to do cutting-edge research in areas such as antibody engineering, drug delivery, and immuno & molecular diagnosis. For the short term, Affigenix also provides custom biosolutions to biopharma companies mainly involved in manufacturing of biologics such as clearance assay development (host cell protein, host cell DNA, and enzymes used in manufacturing process). It has also developed some viable low-volume, high-value immuno-assay products for biosimilar product development, suitable for pharmacokinetic, immunogenicity and potency/NAb assay, biomarker discovery and personalized medicine. "The long-term plan is to discover and develop safe, pure and potent biologics to target complex diseases," he adds. The Pain Of Growing Up During the start-up's inception, locating an industrial area in the city was a humongous task for Dr Arumugam and his team. "Finding an industrial area to comply with the pollution control board's norm and establish a state-of-the-art biotech facility in a modified mechanical shed was the biggest challenge faced by us," he reveals. "Also, there were lots of inordinate delivery delay from the vendors while establishing the wet labs in 2013. In terms of R&D hiccups, we figured it out by trial-and-error methods and went through some usual growing pains," he opines. He feels that in biotech, the industry highly depends on imports of machine and consumables used for the routine day-to-day work. "It is possible with concerted effort and support from Life Sciences industry and academic institutions to make them in India and start exporting," he suggests. For Affigenix, penetration of pricing strategy is another big challenge to face. Going Forward Affigenix's current business model focuses on B2B and it wishes to work with farmers and consumers of diagnostic industry and have a B2C model as well. For the company, scaling up is going to be a slow process. "We serve a very niche market and scaling up is going to be slow due to smaller number of customer base. Besides adopting the B2B model and growing through R&D, we would also like to venture into B2C model and serve the diagnostic (patients) and agro industries (farmers)," expressed Dr Arumugam, who enjoys gardening. The company at the moment is in discussion with biotech companies in Gulf, Singapore, Europe and USA to provide customized product and services for their drug and diagnostic development programs. For FY 2015-16, Affigenix expects a revenue of Rs ~1 crore, and Rs ~4 crores for FY 2016-17. Amending Companies Act Dr Arumugam lauds the Government's funding initiatives to promote Life Sciences start-ups in the country. "Many thanks to the Government for providing seed fundings and other competitive schemes brought through DBT, DBT-BIRAC and DST and through other funding agencies. Our hands are tied-up in competing for many of the research funds in the first three years due to the pre-requisite of having DSIR recognitions to even apply for it. If that restrictions could be removed, it will help start-up companies to secure some additional meritorious funding beyond BIG & SPARSH grants," he comments. He also adds that India needs creative solutions for many of its local and social problems, and that there are many unmet medical needs. "Listing them and seeking solutions is one way to ignite the bright and young minds of our country. Amending Companies Act and allowing Corporate Social Responsibility (CSR) contributions to biotech start-ups and emerging companies who are working with social objectives is one quick way to raise billion-dollar funds," he points. India - A Hot Hub According to Dr Arumugam, India will become a major manufacturing hubs for biologics, clinical trials and medical tourism. "Genome-based diagnostics are next-generation sequencing are hot areas now, and how viable it is as a business is yet to be seen. On the technology front, adapting biological platform such as CAR-T technology and CRISPR/Cas 9 gene editing technology will be on the rise more in academics and start-ups. With government support, and as VC funds are now available here as in the West to biotech SMEs, India could come up with next-generation block buster drugs to treat metabolic, infectious, cancer and autoimmune disorders," Dr Arumugam notes, who likes reading author Jeffrey Archer. He considers Pune and Chennai as more cosmopolitan with good talent pool and high-net worth individuals, therefore, making them very affable as upcoming start-up destinations. He also encourages start-ups to join an incubator or an accelerator due to lesser overhead expenses, collaborative ecosystem and not needing to worry about basic necessities such as power, water and security. How does he manage the entrepreneurial stress? "I manage my time and spend quality time with my friends and family and go on vacation once or twice a year. On weekends I usually go out with my family for dinner or a movie," he explains. The birth of his sons and his PhD supervisor addressing him as 'doctor' after completing his thesis were his glorious moments in life, Dr Arumugam adds, an admirer of world-renowned scientist Dr Robert Langer and iconic businessman Mr Dhirubhai Ambani. When asked about entrepreneurial advice, Dr Arumugam humbly replies, "I don't have enough experience to offer advice, but let them know it will be a roller-coaster ride for the first 999 days for sure." Entrepreneurial Lessons Learnt: ï‚§ Good team with passion and enthusiasm a must ï‚§ Entrepreneur offers freedom and freedom comes with great responsibilityï‚§ Success will not follow success. Success and failures are part and parcel of entrepreneurial lifeï‚§ First million is tough to make and so is the second and so on Entrepreneurial Mistakes To Watch Out For: ï‚§ Not having enough funds and constantly trying to raise it ï‚§ Lacking awareness in IP & regulatory hurdlesï‚§ Lacking good mentors or advisorsï‚§ Poor planning and executionï‚§ Relying only on Government grants Successful Entrepreneurship Needs: ï‚§ Staying focused on goalsï‚§ Ability to multitaskï‚§ Adapting to changes quicklyï‚§ People managing skills ï‚§ Experience and expertise matter than glamorous degrees Life Sciences Start-ups Myth: ï‚§ No competitors at allï‚§ Valuation not possibleï‚§ Quick exit not possibleï‚§ There are no VC and Angels investorsï‚§ Only biotech professionals can begin a company Ways For Start-up Visibility: ï‚§ Client recommendationsï‚§ Conference presentationsï‚§ Publishing research articles in journalsï‚§ Social media (Facebook, LinkedIn, Research Gate) ï‚§ Speaking engagementsï‚§ Through e-commerce start-upsï‚§ Word-of-mouth West System Vs East System: ï‚§ Investors' risk appetite more prevalent in West ï‚§ Gestation time in bringing products to market well understood in Westï‚§ Big biopharma cos acquiring smaller start-ups is the main exit strategy in Westï‚§ Free incubation facilities, tax holidays, sabbatical to faculty members are common in West Top Ways To Raise Start-up Cash: ï‚§ Angelsï‚§ Crowd fundingï‚§ Friends & familyï‚§ Government grantsï‚§ Granting agenciesï‚§ Merging start-upsï‚§ NGOs Seeking Partnerships For: ï‚§ Developing a technology to extend half-life of Biologics (Eg: once-a-week dosing of Insulin)ï‚§ Short-term glycation index monitoring as an alternate to the current long-term hemoglobin glycation index monitoring using HbA1Cï‚§ Developing nano-(anti)bodies that could cross human blood & brain barrierï‚§ Discovering cancer and diabetes biomarker using immuno-proteomics approaches Milestones: ï‚§ DBT-BIRAC-BIG 3 Award for developing Trypsin-resistant antibodies ï‚§ Started generating small revenues with prototype Trypsin-resistant polyclonal antibodies ï‚§ Developed unique monoclonal antibodies (MAbs) having industrial applications including immunomatrix for purifying trypsin, prenatal diagnostic kit for measuring immunoreactive trypsin, and having potential to engineer as therapeutic MAbs for treating Pancreatitis and COPDï‚§ DST-Lockheed Martin-FICCI-IIGP 2014 Top 30 Innovators Award for innovating 'Companion Diagnostics for Diabetes Management'. In discussion with diagnostic company for manufacturing and distributing post regulatory approval in India and 60 other countriesï‚§ Patents filed - 1ï‚§ White paper published - 2 (AAPS Journal)ï‚§ Short Listed for Millennium Alliance Grant ï‚§ BIRAC Fellowship 2015 Ignite Programme at University of Cambridge, UK ]]> <![CDATA[FDA grants QIDP status to new antibiotic of Wockhardt]]> https://biospectrumindia.com/news/95/7796/fda-grants-qidp-status-to-new-antibiotic-of-wockhardt.html https://biospectrumindia.com/news/95/7796/fda-grants-qidp-status-to-new-antibiotic-of-wockhardt.html Tue, 08 Dec 2015 16:50:59 +0530 Wockhardt has announced that United States Food and Drug Administration (USFDA) has granted WCK 5222, a product from their breakthrough new drug discovery program in anti infectives, Qualified Infectious Disease Product (QIDP) status. Dr Habil Khorakiwala, Wockhardt chairman, said, "We are pleased that WCK 5222 has received the QIDP status, fourth for the company in quick succession. WCK 5222 is a new class of antibiotic for gram negative terrain for complicated urinary tract infections and hospital acquired bacterial pneumonia." QIDP status is granted to drugs identified by Centre for Disease Control, US, that act against pathogens which have a high degree of unmet need in their treatment. The status provides fast track clinical development and review of the drug application by the USFDA for drug approval and a five year extension of market exclusivity post product approval in the US. ]]> <![CDATA[Alkem Labs files for IPO]]> https://biospectrumindia.com/news/95/6599/alkem-labs-files-for-ipo.html https://biospectrumindia.com/news/95/6599/alkem-labs-files-for-ipo.html Tue, 08 Dec 2015 12:03:49 +0530 Alkem Laboratories is entering capital market with an initial public offering (IPO) of up to 1,28,53,442 equity shares of Rs 2 each offered by its shareholders. The price band is fixed in the range of Rs 1020-1050 through book building process. The offer open on December 8, 2015 and will close on December 10, 2015. The equity shares offered through Red Herring prospectus are proposed to be listed on BSE and NSE. The global co-ordinators and book running lead managers are Nomura Financial Advisory and Securities (I), Axis Capital, JP Morgan India and Edelweiss Financial Services. Link Intime India will be registrar to the offer. ]]> <![CDATA[Global Graft-versus-Host Disease treatment market to thrive; to touch $545 mn by 2023]]> https://biospectrumindia.com/features/95/7341/global-graft-versus-host-disease-treatment-market-to-thrive-to-touch-545-mn-by-2023.html https://biospectrumindia.com/features/95/7341/global-graft-versus-host-disease-treatment-market-to-thrive-to-touch-545-mn-by-2023.html Mon, 07 Dec 2015 17:37:26 +0530 The company's latest report states that the impressive growth, which will occur across the six Major Markets (6MM) of the US, France, Germany, Spain, Italy and the UK, will be primarily driven by the rising number of allogeneic Hematopoietic Stem Cell Transplantations (HSCTs) and the increasing use of marketed and off-label biologic therapies. However, Dr Eirini Vavatsikou, GlobalData's Senior Analyst covering Immunology, says that: "Despite the vast array of available off-label therapies - approximately 30 - for the treatment and/or prevention of GVHD, very few of these therapies have been tested in large randomized clinical trials. This has resulted in vague treatment recommendations and many patients being enrolled in institutional clinical trials. "The only available standard of care for the treatment of acute and chronic GVHD is intravenous methylprednisolone. However, it fails to produce a complete response in more than 50% of treated patients. As a result, steroid-refractory patient subgroups face a poor prognosis, with a deteriorating quality of life. "This problem is further compounded by the fact that second- and third-line treatments can vary from country to country across the 6MM, and also between different medical institutions within the same country." GlobalData's report also states that Roche's Rituxan has emerged as the most clinically and commercially attractive therapy that is used in both acute GVHD (aGVHD) and chronic GVHD (cGVHD) treatment paradigms due to its growing reputation in the field. Dr Vavatsikou continues: "Rituxan is gaining more and more ground in the cGVHD setting and GlobalData estimates will be one of the best-selling GVHD biologics by value in the US by 2023, with sales of $41.4 million. "Sanofi/Genzyme is another key player in the GVHD market, with EU-approved Thymoglobulin and the off-label biologic therapy, Campath/Lemtrada, which infiltrate the prophylaxis, aGVHD, and cGVHD setting. "Additionally, Johnson & Johnson's Remicade has gained a significant share of the aGVHD patient group, as it is one of the few drugs effective in GVHD with gastrointestinal involvement." ]]> <![CDATA[Contaminated food main cause for food-borne diseases: WHO]]> https://biospectrumindia.com/news/95/7353/contaminated-food-main-cause-for-food-borne-diseases-who.html https://biospectrumindia.com/news/95/7353/contaminated-food-main-cause-for-food-borne-diseases-who.html Mon, 07 Dec 2015 17:36:43 +0530 Three in ten children, under the age of five years, suffer from diarrhea which is a major childhood killer in the Region. These statistics from WHO's first ever report on the estimated burden of foodborne disease underscores the need to take immediate measures to make food safety a public health priority. "The Region accounts for more than half of the global infections and deaths due to typhoid fever or hepatitis A. Foodborne diseases account for a significant proportion of the burden of disease in the Region. Diarrheal diseases are the leading cause of foodborne disease burden in the Region. Some 55 million children under the age of five fall ill and 32000 die from diarrheal diseases in the South-East Asia Region every year," said Dr Poonam Khetrapal Singh, WHO Regional Director for South-East Asia. Food contaminated with harmful bacteria, viruses, parasites, toxins and chemicals are the main causes of foodborne diseases. Consumption of unsafe food causes nausea, vomiting and diarrhea as an immediate effect, and has more serious long-term implications such as cancer, failure of kidney and liver and brain and neural disorders. Foodborne diseases are most dangerous to the young children, pregnant women and older people. In addition to the serious health impact, foodborne diseases present a major cost to economies. "The risk of foodborne diseases is the highest in the low- and middle-income settings where hygiene, safe water for preparing food, and adequate food production and storage conditions remain a challenge. This is further compounded by insufficient food safety legislation or its enforcement," said Dr Poonam. She continued, "The global report is a reminder that governments, the food industry as well as individuals need to make more collaborative efforts to make food safe and prevent foodborne illnesses." Dr Poonam encouraged that all food operators and consumers should understand the roles they must play to protect their health and that of the wider community. "The food safety systems should ensure that food producers and suppliers, along the entire food chain, operate responsibly and supply safe food to consumers. The governments must put in place policies and regulatory frameworks - establishing and implementing effective food safety systems," she added. The deaths and diseases caused by contaminated food can be prevented through improving hygiene, sanitation and other public health measures such as safe drinking water, enforcement of food safety legislation and public awareness and education on safe food handling. "WHO is prioritizing and drawing global attention to food safety," she pointed. This year the theme for the World Health Day, celebrated on 7 April every year, was food safety - from farm to plate, make food safe. ]]> <![CDATA[Cipla launches anti-ageing skin care product Cutisera developed by Stempeutics]]> https://biospectrumindia.com/news/95/7111/cipla-launches-anti-ageing-skin-care-product-cutisera-developed-by-stempeutics.html https://biospectrumindia.com/news/95/7111/cipla-launches-anti-ageing-skin-care-product-cutisera-developed-by-stempeutics.html Mon, 07 Dec 2015 11:32:25 +0530 Cipla has announced that it has launched a novel "5 in 1" anti-ageing skin care product Cutisera developed by Stempeutics. Cutisera has been developed using bio-active factors derived from human adult stem cells to enhance the rejuvenation of ageing skin. The active ingredients have been tested for in vitro and in vivo efficacy. The product has been dermatologically tested with human volunteers with features of ageing skin over a period of 3 months, wherein the product was applied twice a day. This human study has demonstrated Cutisera's effectiveness as a powerful and yet soothing anti-ageing skin care product suitable for all skin types of Indian origin. The formulated product does not contain any stem cells. Commenting on the Cutisera launch, Mr Chandru Chawla, head of Cipla New Ventures said, "We are excited to launch Cutisera, the next generation bio-engineered skin care product. As we age and get exposed to environmental stressors, the production of human growth factors within skin is depleted, giving rise to features of ageing skin. By re-introducing these factors through daily application of Cutisera, damaged skin cells are repaired resulting in rejuvenation of the skin." "We are pleased to market Cutisera through our JV partner Cipla", said Mr BN Manohar CEO of Stempeutics. He added, "Already physician and consumer interest in Cutisera has been high. Cutisera has been developed using a unique & proprietary patent-pending technology that produces stable key ingredients containing growth factors and cytokines in specified amounts - batch after batch. This results in a consistent high quality product bench marked globally." Dr Jaideep Gogtay, chief medical officer of Cipla said, "Improved technology and increased awareness is making people more concerned about their skin, this is driving them to look for skincare products that will not only slowdown the aging process but will also maintain their youthful look for a longer period. It is important to first understand what causes aging and then dealing with the underlying causes. Cutisera exactly does the same. It assists the body's natural biological repair processes to treat damaged skin and prevent further damage." ]]> <![CDATA[Made in India: Infants to receive Sanofi's ShanIPV for polio eradication ]]> https://biospectrumindia.com/news/95/6967/made-in-india-infants-to-receive-sanofis-shanipv-for-polio-eradication-.html https://biospectrumindia.com/news/95/6967/made-in-india-infants-to-receive-sanofis-shanipv-for-polio-eradication-.html Mon, 07 Dec 2015 11:31:18 +0530 Further to India's introduction of IPV in Universal immunization Programme (UIP), Sanofi Pasteur, the vaccines division of Sanofi, announced today the launch of ShanIPV, an injectable inactivated polio vaccine (IPV) by Shri K. Chandrasekhar Rao, Hon'ble Chief Minister of Telangana. ShanIPV will be 'made in India' by Sanofi Pasteur's affiliate Shantha Biotechnics Private Limited in Hyderabad. ShanIPV is a trivalent inactivated, injectable polio vaccine. Declared as a polio-free nation in 2014, heralding a great victory over the disease, India's current war will be waged against its reemergence. This is where ShanIPV, manufactured through technology transfer from Sanofi Pasteur, will make its contribution. India is now poised to progress to the next and final step of polio eradication, the final elimination of all vaccine-related and vaccine-derived polio viruses. This step will secure the future of millions of children in India. Dr Shailesh Ayyangar, MD - India and VP- South Asia, Sanofi commenting on the launch said, "We are proud to further strengthen our commitment towards disease prevention and support the Indian Government's Universal immunization Programme - including polio eradication. With the introduction of IPV in the immunization schedule, our Company is playing a key role in achieving the goal of a polio-free world." Only two countries in the world are still classified as polio endemic, meaning that wild polio virus passes routinely between members of the community. However, great progress has been made in both countries and the last case of polio in the world may possibly be only months away. India has had a very strong focus on polio eradication and this move to introduce IPV in the UIP will provide the required impetus for a polio free India. Mr Jean-Pierre Baylet, country head - Vaccines, Sanofi Pasteur, India said, "Sanofi Pasteur has been a public health partner to India for over 20 years. We welcome the Government of India's decision to introduce IPV in the immunization program to eliminate the risk of polio virus resurgence. This is a big milestone in the Country towards ensuring a future when no child succumbs to this vaccine-preventable disease. We are very pleased that Sanofi Pasteur and Shantha Biotechnics supply vital technological know-how and are key partners to the Government of India, WHO and UNICEF for polio eradication in the Country." In line with the WHO's Global endgame strategy, India is introducing one dose of IPV at 14 weeks of age. IPV is to be given in addition to the existing oral polio vaccine. This introduction is a critical step towards achieving a polio-free world by 2019 to meet the Global Polio Eradication Initiative (GPEI) Endgame Strategic Plan. Dr Mahesh Bhalgat, executive director and chief operating officer, Shantha Biotechnics, India said, "At Shantha, our goal is to deliver healthcare solutions, which can be accessed by the common man in India. Towards the polio eradication programme, we will manufacture massive quantities of high-quality, safe and efficacious IPV vaccine to meet all the milestones in the timeline set by the Indian Government." ]]> <![CDATA[Sun Pharma gets FDA approval for generic Gleevec]]> https://biospectrumindia.com/news/95/7069/sun-pharma-gets-fda-approval-for-generic-gleevec.html https://biospectrumindia.com/news/95/7069/sun-pharma-gets-fda-approval-for-generic-gleevec.html Fri, 04 Dec 2015 17:52:21 +0530 Sun Pharmaceutical has announced that one of its subsidiaries has received final approval from the US FDA for its Abbreviated New Drug Application (ANDA) for generic version of Gleevec, Imatinib Mesylate tablets 100mg and 400mg. Imatinib Mesylate tablets, 100 mg and 400 mg are therapeutic equivalents of Novartis' Gleevec tablets. As per IMS MAT August 2015, these tablets have annual sales of approximately $2.5 billion in the US. These tablets are indicated for the treatment of chronic myeloid leukemia. The Sun Pharma subsidiary, being the first-to-file an ANDA for generic Gleevec with a para IV certification, is eligible for 180-days marketing exclusivity in the US. Under the terms of a settlement agreement with Novartis, the Sun Pharma subsidiary is permitted to launch its version of generic Gleevec in the United States on February 1, 2016. ]]> <![CDATA[AstraZeneca to shut down its Bengaluru API unit]]> https://biospectrumindia.com/news/95/4618/astrazeneca-to-shut-down-its-bengaluru-api-unit.html https://biospectrumindia.com/news/95/4618/astrazeneca-to-shut-down-its-bengaluru-api-unit.html Fri, 04 Dec 2015 11:51:07 +0530 "The decision was taken following an application to the Drug Controller General of India (DCGI) to withdraw the manufacturing licence for Terbutaline Sulphate (TBS). The product was manufactured primarily for export and the company applied to withdraw the licence following low demand in the export markets," AstraZeneca Pharma India said in a filing to BSE. "The Board took the decision as TBS was the last API to be manufactured at the API unit and no other API manufacturing activity is planned to be carried out at this unit in the future," it added. The company's tablet manufacturing plant that started commercial operations in 2013 will continue to operate at the above mentioned location, AstraZeneca said. ]]> <![CDATA[GSK partners with Canada-based Zymeworks]]> https://biospectrumindia.com/news/95/6964/gsk-partners-with-canada-based-zymeworks.html https://biospectrumindia.com/news/95/6964/gsk-partners-with-canada-based-zymeworks.html Fri, 04 Dec 2015 11:50:28 +0530 Zymeworks has announced that it has entered into a collaboration and license agreement with GlaxoSmithKline (GSK) for the research, development, and commercialization of novel Fc-engineered monoclonal and bi-specific antibody therapeutics which have been optimized for specific therapeutic effects. Under the terms of the agreement, Zymeworks and GSK will collaborate to further develop Zymeworks' Effector Function Enhancement and Control Technology (EFECT) platform through the design, engineering, and testing of novel engineered Fc domains tailored to induce specific antibody-mediated immune responses. At the conclusion of the research collaboration, both GSK and Zymeworks will have the right to develop and commercialize monoclonal and bi-specific antibody candidates that incorporate Zymeworks' optimized immune-modulating Fc domains. Under the terms of the agreement, GSK will have the right to develop a minimum of 4 products across multiple disease areas, and Zymeworks will be eligible to receive pre-clinical, clinical, and commercial milestones of upto $110 million for each product, as well as tiered sales royalties. Further financial details are not disclosed. "We are thrilled to collaborate with GSK on the development of next-generation antibody therapeutics that incorporate the EFECT platform to help fight life-threatening diseases," said Dr Ali Tehrani, president and CEO of Zymeworks. He added, "This is a unique opportunity for Zymeworks to apply our antibody engineering expertise in collaboration with GSK's drug discovery capabilities to develop and commercialize novel antibody therapeutics. The collaboration will also allow Zymeworks to combine the novel immune-modulating Fc domains with our Azymetric platform to generate bi-specific antibodies with customized immune modulatory functions." ]]> <![CDATA[Dr Henk Bekedam is the new WHO representative to India]]> https://biospectrumindia.com/news/95/3253/dr-henk-bekedam-is-the-new-who-representative-to-india.html https://biospectrumindia.com/news/95/3253/dr-henk-bekedam-is-the-new-who-representative-to-india.html Fri, 04 Dec 2015 11:49:51 +0530 Dr Henk Bekedam is a Dutch national and a medical doctor by training. He acquired his MSc in Economics from the London School of Economics in 1996. Having an overall experience of 29 years, he has worked for 19 years with the World Health Organization (WHO) as Representative in China and Egypt, Director of Health Sector Development in the WHO Western Pacific Region Office in Manila and as team leader of the health sector reform project in Cambodia. Before joining WHO, Dr Bekedam was seconded to governments in Zambia and Malawi. Speaking of his new role, Dr Bekedam said, "It is a privilege to be in India. I am looking forward to building upon and further strengthening the excellent partnership that WHO has with the Ministry of Health & Family Welfare and with other stakeholders." "WHO India will continue to strive towards further strengthening health and equity in the country, as India takes major steps towards Universal Health Coverage," he added. Dr Bekedam is happy to be back in Asia, where his work included supporting the Chinese government to successfully contain the SARS outbreak in 2003. This was one of his most impactful work as it not only led to a substantial increase in investment in public health, but also paved the way for universal health coverage in China. "A similar outcome was seen in Egypt, where we assisted the national government to define a new vision of universal health coverage in response to the Constitution adopted in 2014, which gave more attention to health and education," he added.Dr Bekedam and the country office team also provided sound technical advice to the Egyptian government for an effective response to the largest outbreak of avian flu in humans and containing viral hepatitis C, including the expansion of the treatment programme. In addition, along with his team, he worked closely with the government to maintain the country's polio-free status. Other areas of Dr Bekedam's strong expertise include, health system strengthening, Universal Health Coverage health sector reforms, food safety, AIDS, tuberculosis, tobacco control and chronic diseases. ]]> <![CDATA[Aurobindo's Osteoporosis drug bags FDA approval]]> https://biospectrumindia.com/news/95/6997/aurobindos-osteoporosis-drug-bags-fda-approval.html https://biospectrumindia.com/news/95/6997/aurobindos-osteoporosis-drug-bags-fda-approval.html Thu, 03 Dec 2015 11:09:50 +0530 Aurobindo Pharma Ltd announced that the company has received final approval from the US Food and Drug Administration (USFDA) to manufacture and market Risedronate Sodium Tablets USP, 5 mg, 30 mg and 35 mg (ANDA 200296). This approval is an extension of tentative approval received on 10th October 2012. This product is ready for launch. The approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) ACTONEL Tablets of Warner Chilcott. Risedronate Sodium Tablets are used in the treatment of Osteoporosis. The approved product has an estimated market size of $113 million for the twelve months ending October 2015 according to IMS. ]]> <![CDATA[Monsanto plans carbon-neutral ops by 2021]]> https://biospectrumindia.com/news/95/6836/monsanto-plans-carbon-neutral-ops-by-2021.html https://biospectrumindia.com/news/95/6836/monsanto-plans-carbon-neutral-ops-by-2021.html Wed, 02 Dec 2015 12:14:29 +0530 As agriculture and farmers around the world work to mitigate and adapt to the complex challenges posed by climate change, Monsanto announced plans to make its operations carbon neutral by 2021 through a unique program targeted across its seed and crop protection operations, as well as through collaboration with farmers. "Climate change is one of the biggest issues we face in agriculture, as well as one of the most pressing challenges facing humanity," said Mr Hugh Grant, Monsanto's chairman and CEO. "That's why we have pledged to do our part within our own business and to help support farmers and others. While progress has been made to reduce agriculture's carbon footprint, we must work collectively to do even more if we are going to sustainably feed 9.6 billion people by 2050. Agriculture is uniquely positioned to deliver climate change solutions, and we hope that policy makers recognize the role agriculture, farmers and crops can play in mitigating carbon emissions." ]]> <![CDATA[Opioid-induced constipation treatment market to boom to $650 mn by 2019]]> https://biospectrumindia.com/features/95/7828/opioid-induced-constipation-treatment-market-to-boom-to-650-mn-by-2019.html https://biospectrumindia.com/features/95/7828/opioid-induced-constipation-treatment-market-to-boom-to-650-mn-by-2019.html Wed, 02 Dec 2015 11:46:08 +0530 The opioid-induced constipation treatment market across the six major countries of the US, Germany, France, Italy, Spain and the UK will increase from an estimated $66.7 million in 2014 to $652.4 million by 2019, representing a rapid Compound Annual Growth Rate (CAGR) of 57.8%, according to research and consulting firm GlobalData. The company's latest report states that the rising number of opioid-induced constipation sufferers is largely down to overall population increase and the continued use of opioids in the treatment of chronic non-cancer pain, which is driving impressive market growth. Dr Claire Gibson, GlobalData's Analyst covering Cardiovascular and Metabolic Disorders, says that the introduction of novel targeted oral therapies for opioid-induced constipation, such as peripherally-acting mu-opioid receptor antagonists (PAMORAs), will be a major driver of market growth during the forecast period. Dr Gibson explains: "While there is currently only one approved PAMORA, AstraZeneca's Movantik, the anticipated approval of another four PAMORAs in the US and Europe during the forecast period will mark a shift in the way that drugs for opioid-induced constipation are prescribed. "Although laxatives are likely to remain the first-line therapy, the advent of these highly-targeted drugs will increase the number of patients receiving non-laxative prescription treatments for opioid-induced constipation." Dr Gibson continues: "The US is responsible for consuming 80% of the global opioid supply, despite making up just 4.6% of the global population. Opioids are the most commonly prescribed class of medication in the US, which is mainly due to an increasing awareness of chronic pain and its effect on patient quality of life. "Patient and physician awareness is key to the development and use of opioid-induced constipation treatment, with US sales figures demonstrating the impact such awareness can have on the market." ]]> <![CDATA[Jubilant gets FDA approval for antidepressant generic]]> https://biospectrumindia.com/news/95/7784/jubilant-gets-fda-approval-for-antidepressant-generic.html https://biospectrumindia.com/news/95/7784/jubilant-gets-fda-approval-for-antidepressant-generic.html Wed, 02 Dec 2015 11:45:13 +0530 Jubilant Life Sciences has received Abbreviated New Drug Application (ANDA) final approval from the US Food and Drug Administration (US FDA) for Paroxetine Tablets USP, 10 mg, 20 mg, 30 mg and 40 mg. The tablets are the generic version of Paxil Tablets, 10 mg, 20 mg, 30 mg, and 40 mg (of Apotex), which is used as an antidepressant. As on September 30, 2015, Jubilant Life Sciences had a total of 820 filings for formulations of which 391 have been approved in various regions globally. ]]> <![CDATA[First doses of injectable Polio vaccine soon available for Indian infants]]> https://biospectrumindia.com/news/95/6979/first-doses-of-injectable-polio-vaccine-soon-available-for-indian-infants.html https://biospectrumindia.com/news/95/6979/first-doses-of-injectable-polio-vaccine-soon-available-for-indian-infants.html Tue, 01 Dec 2015 14:23:36 +0530 Sanofi Pasteur, the vaccines division of Sanofi, announced that the first shipment of ShanIPV, a brand new injectable, inactivated polio vaccine (IPV) manufactured by its affiliate Shantha Biotechnics, in Hyderabad, India, will occur in a couple of days. These first vaccine doses will be available to implement one dose of IPV in India's immunization schedule for all infants. Today, India is officially introducing IPV in their national immunization schedule, to supplement the iconic "drops on sugar" of oral polio vaccine (OPV). Over 20 million newborns will eventually benefit from this new vaccine every year. This is a critical step towards a polio-free future, a prospect that is now very close. India's 2014 certification as polio-free reassured experts that the decades-long global fight against polio was finally drawing to an end. Sanofi Pasteur and its affiliate Shantha Biotechnics will together produce most of India's IPV supply. "With the introduction of IPV in their immunization schedule, India moves the world much closer to being polio-free", said Mr Olivier Charmeil, President and CEO, Sanofi Pasteur. "As a company deeply rooted in India, we are very proud that vaccines produced by both Sanofi Pasteur and Shantha will be used in this vital step towards a polio-free world. We have worked as partners of the government of India for many years, with this day in mind." Only two countries in the world are still classified as polio endemic, meaning that wild polio virus passes routinely between members of the community. However, great progress has been made in both countries and the last case of polio in the world may possibly be only months away. OPV has been instrumental in ending polio cases in India and has been used across the world to reduce the number of cases of polio by over 99 percent in the past twenty years. Today, the World Health Organization (WHO) recommends that the live OPV be supplemented and then replaced by an inactivated IPV. OPV and IPV stimulate the body's immune system in slightly different ways so children who receive both should be even better protected against the disease. When the world is polio-free, IPV will be the only vaccine used to make sure that the disease never comes back, according to a 2012 WHO policy. OPV contains a mixture of live attenuated poliovirus strains. Although OPV is safe it is not advisable to be used after achieving a polio-free status: when polio no longer exists in the wild, live virus cannot still exist in a vaccine. The universal introduction of IPV, a vaccine that has been used in many countries of the world for years, is a necessary step towards achieving a polio-free world by 2019 according to the Global Polio Eradication Initiative (GPEI) Endgame Strategic Plan. Today, more than 110 countries have introduced IPV in their immunization calendars. In February 2014, Sanofi Pasteur - the world's largest producer of IPV - and the Bill & Melinda Gates Foundation announced a joint price support mechanism, including a financial contribution from both organizations. The mechanism allows Gavi to make IPV available for inclusion in the routine immunization schedules in 73 of the world's poorest countries. Sanofi Pasteur, as a leader in providing both OPV and IPV, has been a partner of the Global Polio Eradication Initiative for over 20 years. The company has provided more than five billion doses of OPV to UNICEF over last two decades. In 1982, Sanofi Pasteur registered the first enhanced-potency inactivated polio vaccine (IPV), which is now distributed globally as a stand-alone poliovirus vaccine as well as in combination pediatric vaccines to immunize against many diseases in a single shot. Since then, Sanofi Pasteur has distributed more than one billion doses of IPV and IPV-containing vaccines. ]]> <![CDATA[Renew resolve to end AIDS: WHO on World Aids Day]]> https://biospectrumindia.com/news/95/7462/renew-resolve-to-end-aids-who-on-world-aids-day.html https://biospectrumindia.com/news/95/7462/renew-resolve-to-end-aids-who-on-world-aids-day.html Tue, 01 Dec 2015 13:11:59 +0530 Close to 16 million people are now receiving antiretroviral treatment. In WHO South-East Asia Region, new infections declined by 32% between 2000 and 2014. Almost 1.3 million people are on antiretroviral treatment (ART). "However, gaps remain. More than half of the people with HIV are unaware of their status. Those who test, do so late when they have symptoms and their immune systems are already compromised. Only 36% of the people living with HIV in the Region are on treatment; and fewer than 30% of people with HIV are able to get to the last point when HIV virus multiplication in their body is suppressed which is essential to prevent further transmission," said Dr Poonam Khetrapal Singh, Regional Director, WHO South-East Asia Region. The new Sustainable Development Agenda includes the target of ending the AIDS epidemic by 2030 - by reducing the number of new infections by an additional 25% by 2020; ensuring that 90% of people living with HIV are aware of their infection and 90% of them are on ART, and 90% of those on ART have no detectable virus in their blood. "Bold actions will be required to achieve the target for ending AIDS by 2030," said Dr Poonam, " with the health sector playing a central role. Countries need to prioritize HIV interventions to get the highest impact. This includes using newer approaches for testing like community based HIV testing, ensuring that all HIV positive people are started on treatment and those identified negative, especially who are at risk have access to HIV prevention and re-testing services." According to her, the new targets are ambitious but achievable. She added, "By the end of 2014, Thailand had tested and enrolled more than 60% of its people living with HIV into treatment. It is one of ten countries in the world to have achieved this distinction. Many other countries in the Region can and must accelerate and scale up HIV testing and treatment programmes. "Efforts over the next five years will decide whether we will end AIDS by 2030 or face resurgence. In over four decades of the epidemic, science, social mobilization, political commitment and coordinated response among key stakeholders have made it possible to end AIDS. History shall not be kind to us if we become complacent now." She pointed that ending AIDS will require investments, but will be worthwhile. "Countries in the Region are leading the way in funding HIV response through domestic budgets, but more remains to be done. We need to ensure that HIV response is firmly positioned in the development and health agenda of the Sustainable Development Goals. We need to ensure that community responses are not only sustained, but further scaled up and fully funded. Stigma, discrimination and punitive laws still hamper access to key services for those most in need. We need to reaffirm and renew our resolve to work towards realizing our goal of ending AIDS in the WHO South-East Asia Region by 2030," she opined. ]]> <![CDATA[FDA nod for BMS/AbbVie's multiple myeloma drug ]]> https://biospectrumindia.com/news/95/6535/fda-nod-for-bms-abbvies-multiple-myeloma-drug-.html https://biospectrumindia.com/news/95/6535/fda-nod-for-bms-abbvies-multiple-myeloma-drug-.html Tue, 01 Dec 2015 12:21:39 +0530 Bristol-Myers Squibb Company and AbbVie has announced the US Food and Drug Administration (US FDA) has approved Empliciti (elotuzumab) for the treatment of multiple myeloma as combination therapy with Revlimid (lenalidomide) and dexamethasone (ERd) in patients who have received one to three prior therapies. The approval of this first and only immunostimulatory antibody for multiple myeloma is based on data from the randomized, open-label, Phase 3, ELOQUENT-2 study, which demonstrated that the ERd regimen resulted in a 30 percent reduction in the risk of disease progression or death compared to Rd alone. "At Bristol-Myers Squibb, we are leading a revolution in cancer treatment that is changing expectations for patients with some of the hardest-to-treat cancers. With today's approval of Empliciti, we are pleased to now bring the promise of our Immuno-Oncology research to patients with multiple myeloma," said Dr Francis Cuss, chief scientific officer, Bristol-Myers Squibb. "Empliciti represents a fundamentally different approach of directly activating the immune system in patients with relapsed or refractory multiple myeloma, delivering improved outcomes for those in need." Empliciti is available for injection for intravenous use in 300 mg and 400 mg vials. The company expects to begin shipping Empliciti within the next 48 hours. Empliciti is also under review by the European Medicines Agency and has been granted accelerated assessment. Discontinuation rates due to adverse reactions were similar across the ERd and Rd control arms (6.0 vs. 6.3 percent). ERd is associated with the following Warnings and Precautions: Infusion Reactions, Infections, Second Primary Malignancies, Hepatotoxicity, Interference with Determination of Complete Response, Pregnancy/Females and Males of Reproductive Potential, and Adverse Reactions. Please see the detailed Important Safety Information and a link to the Prescribing Information below. "Empliciti in combination with lenalidomide and dexamethasone is an important new option for patients with multiple myeloma and healthcare providers who are treating this cancer," said Dr Michael Severino, executive vice president of research and development and chief scientific officer, AbbVie. "AbbVie is pleased to have partnered with Bristol-Myers Squibb in making this new treatment available for patients with relapsed or refractory multiple myeloma." ]]> <![CDATA[â€œInteractive website essential for healthcare companiesâ€? ]]> https://biospectrumindia.com/views/95/7966/interactive-website-essential-for-healthcare-companies-.html https://biospectrumindia.com/views/95/7966/interactive-website-essential-for-healthcare-companies-.html Tue, 01 Dec 2015 10:31:02 +0530 Healthcare sector is one of the most vital and substantially allotted part in every economy. Also known as medical sector, this is an aggregation of sectors within economic sector. This is as important as the national development because it has been dealing with services that provides goods and medical services to treat patients with preventive, curative and rehabilitative care. Commonly known as medical economy, this also includes the generation and commercialization of goods and services. Being one of the world's largest and fastest-growing industries, this sector has been consuming more than 10 percent of the GDP of the developed nations, for developing the amount that can be estimated. Not only this, but this sector is also consuming an enormous part of country's economic development as well. Divided into various disciplines, healthcare sector is broadly classified into hospital services, medicinal & dental practice activities and other human health activities. This categorization has been done under the norms of International Standard Industrial Classification (ISIC). In such scenario, online development becomes an important tool for patients to get connected with doctor and among themselves. Gone are those days, when patients were completely dependent on the single doctor for their treatment. Today's patient is very smart in deciding the treatment. He or she makes sure that no befooling is done and ensure that they have been rendered with the best possible service. It is not that this sector has come up like a bubble, but it has been developed over a period of time. In the 19th century, United States passed a federal law for building asylums for the indigent insane, blind and deaf. This was the time when hospitals were being constructed to treat the patients dying from en-slavery. With time came the development in this field as well, as with increase in other physical, emotional and natural factor the need for a rapid increase in the hospital and medical care became a necessity. Thus, more and more hospitals were being constructed all across the globe. Under the hospital services, in today's world, most of the hospitals make sure that the doctors on its panel are made available over the internet. A comprehensive details of their experience, education and other hospitals, is mentioned over the website. Not only this, but some of the most successful operations or surgeries are also mentioned. This information is useful to the patient in deciding whether to avail the service or not. The patient can understand this crucial piece of information as a testimony of the successful treatment rendered by doctor. Under medicinal services, having a comprehensive set of information over the internet is useful in deciding the medicine. Giants including Cipla, GSK and other pharmaceutical companies manufacturing medicines also put comprehensive detailed information of the medicine over internet. This information includes the salt and composition of medicine. This composition is useful to the patient in comparing the medicine, its usage and deciding the alternative salt as well. Thus, comprehensive web information over the medicine is also very useful to the patient in multiple ways. The third category includes the services being rendered by nurses, midwives, physiotherapists, scientific or diagnostic laboratories, pathology clinics, residential health facilities, or other allied health professions. Health insurance, another important sector of health and medical fraternity is also growing rapidly. For all these peripherals, there is one thing in common and that is nothing but the internet. A medium of information transfer from one place to another, this is one of the most vital method of transmitting the details. Patients can now easily come in the contact of their doctors and fellow specialists over the internet. The World Health Organization has estimated that there are about 9.2 million physicians, 19.4 million nurses and midwives. 1.9 million Dentists and other dentistry personnel, 2.6 million pharmacists and other pharmaceutical personnel and over 1.3 million community health workers worldwide. All these can be connected through only one medium and that is nothing else but the medium of internet. Thus, a comprehensively designed website, providing the in-depth details of the drugs, equipments, methods, services and doctors themselves, is a perfect solution and a necessary tool for this century's healthcare industry. About Author: Mr Rajat S Berry holds a Bachelor's degree in Economics from Hindu College, Delhi University. His real passion, however, has always been in the realm of design and communication; the web and the technological prowess possible through it was the extension of this love for communication design. Rajat set up Cross Section Interactive in 2001, a web development agency based out of New Delhi. Under Rajat's mantle, the company has grown over 50 full-time employees with expertise in various web technologies. Core services include design, development, and maintenance. ]]> <![CDATA[vBT contest 2015 held in HP]]> https://biospectrumindia.com/news/95/7702/vbt-contest-2015-held-in-hp.html https://biospectrumindia.com/news/95/7702/vbt-contest-2015-held-in-hp.html Mon, 30 Nov 2015 13:57:13 +0530 'voice for BT' (vBT), an intercollegiate public speaking contest on Biotechnology, is a platform for the undergraduate biotech students to voice their opinion on the key role biotechnology can play in solving challenging problems that the nation, and the world is facing in recent times. The event was hosted at the Jaypee University of Information Technology (JUIT), Waknaghat, Solan (Himachal Pradesh). Participants from 31 different institutes across north India, gathered on September 25, 2015 at the JUIT campus. The panel of judges included Mr Mads Bjornvad, R&D head Novozymes, Mr G S Krishnan, regional president Novozymes, Mr Divakar Rao, advisor, Life Sciences Sector, Govt. of Karnataka, and Mr Narayanan Suresh, group editor, BioSpectrum Magazine. Participants spoke on subjects including, 'Importance of Cleaner Environment and the role of Biotech Tools'; 'Application of Agricultural Biotechnology in improving food nutrition in crops'; and 'Importance of waste to energy and the role of Biotechnology'. Each student was given 5 minutes. The event was also witnessed by Prof. Samir Dev Gupta, director (Academic) and Brig. (Retd.) Balbir Singh, director (Admn.) of the JUIT, and Prof. R S Chauhan, dean Biotechnology, JUIT Waknaghat. Ms Prateeksha Kaul, a biotech graduate from Meerut Institute of Engineering & Technology bagged the first prize. Ms Harmandeep Kaur from S D College, Chandigarh, secured the position of first runner-up followed by Ms Merlit Matthews from Amity University, Jaipur, Rajasthan as the second runner-up. The winner, Ms Kaul was awarded with a cash prize of Rs 25,000. The first runner-up was given a prize of Rs 15,000 and the second runner-up Rs 10,000. The winner and runners-up were also offered an internship at Novozymes R&D facility in Bangalore, for 3 months, 2 months and 1 month respectively. ]]> <![CDATA[Cipla to launch low-dose Efavirenz for HIV infection]]> https://biospectrumindia.com/news/95/6416/cipla-to-launch-low-dose-efavirenz-for-hiv-infection.html https://biospectrumindia.com/news/95/6416/cipla-to-launch-low-dose-efavirenz-for-hiv-infection.html Mon, 30 Nov 2015 12:14:24 +0530 Cipla announced its readiness to supply its combinations Tenofovir/ Emtricitabine / Efavirenz and Tenofovir/ Lamivudine /Efavirenz with a dose of 400 mg of Efavirenz as a first-line initial therapy for HIV infection. Efavirenz 600 mg is currently used in antiretroviral therapy (ART) and is highly effective. However, it is known to have significant side effects, which can be very distressing for those taking it for treatment of HIV infection. Efavirenz 400 mg, with the same efficacy, is much better tolerated. It is expected that this improved formulation will help improve patient adherence as well as significantly reduce the cost of treatment. In addition it will also significantly reduce the pill size. Studies found that the reduced dose of 400 mg Efavirenz was non-inferior to the standard dose of 600 mg Efavirenz dose when combined with Tenofovir/ Emtricitabine (TDF/FTC) and Tenofovir/ Lamivudine (TDF/ 3TC) as initial HIV therapy. Both doses demonstrated similar safety profiles. According to UNAIDS, there are approximately 37 million worldwide people living with HIV of which around 15.8 million people are reported to be receiving ART. WHO recently announced that it recommended to make ART available to all HIV-infected patients as soon as they are tested positive. This strategy should dramatically decrease HIV transmission but will require largeadditional resources, as the cost of ART remains substantial in spite of price reductions by manufacturers. One way to reduce the drug costs of therapy further is "dose optimization". Reducing the dose of Efavirenz in current first-line combination therapy to 400 mg will contribute to reducing costs without modifying the effectiveness of treatment. It is expected that new guidelines for HIV treatment will include this dose reduction to Efavirenz 400 mg. ]]> <![CDATA[3D bio-printing market worth $1.82 bn By 2022]]> https://biospectrumindia.com/features/95/7711/3d-bio-printing-market-worth-1-82-bn-by-2022.html https://biospectrumindia.com/features/95/7711/3d-bio-printing-market-worth-1-82-bn-by-2022.html Fri, 27 Nov 2015 15:04:42 +0530 The global 3D bio-printing market size was valued at USD 487.0 million in 2014 and is expected to witness significant growth and attention from healthcare researchers over the forecast period due to, the rising incidences of chronic illnesses leading to organ and tissue transplants coupled with increasing life span of individuals and limited number of organ donors. According to market research and consulting firm Grand View Research, advancement in technology and incorporation of IT within the healthcare industry, rising geriatric population base and improving R&D efforts for the sector are likely to serve as high impact rendering drivers for this market. As of 2015, numerous universities and research institutes have begun analyzing the prospects of bio-printed implants, organs and tissue reconstructions. For instance, the Heriot-Watt University of Scotland created a 3D bio-printer capable of printing pluripotent stem cell cultures that may be applied for drug testing. Another example portraying the substantial development is the recently accomplished thyroid gland transplantation in mice by 3D Bio, for treating hypothyroidism. If results are favorable, the company would start testing it for human use in the next two years. Technologies used in the 3D bio-printing industry include magnetic levitation, inkjet based, syringe based, and laser based 3D bio-printing. Magnetic levitation along with syringe based 3D bio-printers held the largest share in 2014 whereas laser technology is expected to witness the fastest growth. Also, syringe based technology is anticipated to gain higher adaptation over the next seven years. The next generation magnetic levitation 3D bio-printers are expected to solve more that 80% of the current failures encountered along with enhanced speed and precision. Magnetic levitation printers find application in toxicity screening, vascular smooth muscle printing, human cell generation and their drug response management. BioAssay is a company dealing with manufacturing of tissue-like structure which makes use of these printers on a large scale to benefit from magnetic levitation technology. Key applications analyzed in the study include dental, medical, biosensors, bioinks, food and animal product bio-printing and consumer/personal product testing. The medical segment is expected to dominate the market with over 30.0% share in 2022 and cover the regeneration of organs, tissues, implants and prosthetics along with medical pill production. Medical pills are the latest development in the 3D bio-printing market and are expected to witness lucrative growth over the forecast period. This growth may be attributed to the increasing need of medicines and the advantage of fast and cost efficient production of biodrugs using 3D bio-printing. According to various industry experts, the pharmaceutical industry is expected to grow multi-folds, thereby increasing the volume of medical pill production. Aprecia Pharmaceuticals received the first ever USFDA approval for 3D printing of their drug Spritam in August 2015. The drug would have therapeutic action in treatment of epileptic patients. North America is anticipated to dominate the global market in terms of revenue over the forecast period. It held over 35.0% of the market share as of 2014 is expected to grow at CAGR of over 10.0%. Presence of a huge geriatric and chronically ill population within the region coupled with refined healthcare infrastructure and reasonably higher patient disposable income levels are the key drivers of this market. Furthermore, extensive research activities currently conducted within the region are expected to be vital growth factor over the forecast period. The Wake Forest University of North Carolina presented their research for development of customized medication at the American Heart Association Scientific Sessions (AHASS) in November 2015. The pills would be designed according to the biological profile of each patient which includes, organ function capacity, weight, gender and race. Asia Pacific is expected to witness lucrative growth owing to their pioneering presence in development of healthcare IT and quick adaption of technological advancements. Furthermore, rising awareness level, increasing foreign investments within the region for the purpose of research and supportive government initiatives is expected to propel this development over the next seven years. Key players operating in the 3D bio-printing industry include Organovo Holding, Cyfuse Biomedical, BioBots, Luxexcel Group BV, TeVido BioDevices, Aspect Biosystems, 3Dynamics Systems, Stratasys, Voxeljet, Oceanz, Materialise NV, Envision TEC, Bio3D Technologies, Solidscape and others. Most of the market players have formed tie-ups with research institutes and universities that work on grafting and organ regeneration technologies. Also, the players are scheduling various exhibitions and seminars in order to raise awareness regarding the industry globally. ]]> <![CDATA[Magnisense raises â‚¬5.5 mn to better diagnose CVDs]]> https://biospectrumindia.com/news/95/4446/magnisense-raises-5-5-mn-to-better-diagnose-cvds.html https://biospectrumindia.com/news/95/4446/magnisense-raises-5-5-mn-to-better-diagnose-cvds.html Fri, 27 Nov 2015 14:08:22 +0530 New shareholders have bought stakes worth a total of â‚¬4.5 million, with the bulk of the investment coming from Minv. Magnisense's long-term shareholders - primarily Provestis and Concorde Capital - have also taken part in the fundraising campaign. This capital increase provides Magnisense with additional resources and expertise to prepare for its European products launch. Magnisense develops robust, portable and economical quantitative blood tests used to diagnose myocardial infarction in 15 minutes. Following current care procedures at the hospital, this can take several hours. Magnisense's tests will save lives, improve therapeutic care for people having a myocardial infarction and reduce long-term hospital stays, lasting damage and the need for lifelong assisted care. This technology will also lower direct and indirect public health costs associated with these diseases. The tests offer a solution adapted to meet a real need and to overcome the major public health challenges involved. Dr Lyse Santoro, CEO of Magnisense, said, "We are delighted to welcome Robert Taub and Jean-Pierre Dubuc to the Board of Directors of Magnisense. Their experience in the healthcare industry and their commitment give us a key advantage for the launch of our products in Europe. By joining Magnisense, they have acknowledged the quality of our teams, the validity of our strategy, the potential of our technology and its capacity to meet genuine market needs," she stated. "Today Magnisense has the resources to achieve its goal of becoming an innovator in the emergency diagnosis of cardiovascular diseases. We are ramping up our operations to register, industrialize and prepare our products for the market while strengthening our partnerships with hospitals." ]]> <![CDATA[Dr Reddy's gets extra time to respond to warning letter]]> https://biospectrumindia.com/news/95/3251/dr-reddys-gets-extra-time-to-respond-to-warning-letter.html https://biospectrumindia.com/news/95/3251/dr-reddys-gets-extra-time-to-respond-to-warning-letter.html Fri, 27 Nov 2015 11:10:01 +0530 Dr Reddy's Laboratories (DRL) has said that the US Food and Drug Administration (US FDA) has extended the time-frame for replying to the warning letter issued to the company by about two weeks to 7 December. On November 5, 2015, the company has received a warning letter issued by the US health regulator relating to its API manufacturing facilities at Srikakulam, Andhra Pradesh and Miryalaguda, Telangana, as well as Oncology Formulation manufacturing facility at Duvvada, Visakhapatnam, Andhra Pradesh. Dr Reddy's is in the process of preparing a response to FDA's warning letter. The FDA has granted an extension until December 7, 2015 for the submission of the Company's response to its warning letter. ]]> <![CDATA[Novo Nordisk, Ablynx partner for Nanobody drug discovery ]]> https://biospectrumindia.com/news/95/8045/novo-nordisk-ablynx-partner-for-nanobody-drug-discovery-.html https://biospectrumindia.com/news/95/8045/novo-nordisk-ablynx-partner-for-nanobody-drug-discovery-.html Fri, 27 Nov 2015 10:40:37 +0530 Ablynx has announced that it has entered into a global exclusive collaboration and licensing agreement with Novo Nordisk to discover and develop novel multi-specific Nanobody drug candidates for use in an undisclosed disease area, with an option to expand the agreement to include a second Nanobody programme. Under the terms of the agreement, Ablynx will receive an upfront license fee of â‚¬5 million (or approx. $5.3 million ) and up to â‚¬4 ($4.3 million) million in research funding during the initial three year research term of the collaboration. If Novo Nordisk decides to exercise the option to the second programme, the Company will pay Ablynx an exercise fee of â‚¬4 million ($4.3 million). In addition, Ablynx is eligible to receive potential development, regulatory and commercial milestone payments of up to â‚¬182 million ($193 million) per programme plus tiered royalties on the annual net sales on any products resulting from the collaboration. Novo Nordisk will be responsible for the development, manufacturing and commercialisation of any products resulting from this agreement. Dr Edwin Moses, CEO of Ablynx commented, "Our proprietary Nanobody technology platform is ideally suited to develop multi-specific Nanobody candidates that address multiple targets in a single drug molecule, applicable across a wide range of diseases. Today's agreement with Novo Nordisk is another endorsement of the power, broad applicability and versatility of our technology, building further on the breadth and depth of our current partnerships with top tier pharmaceutical companies and the knowledge we have gained from developing our proprietary programmes. We are looking forward to working for the first time with Novo Nordisk." ]]> <![CDATA[Global Type 1 Diabetes Mellitus market value will exceed $7 bn by 2021]]> https://biospectrumindia.com/features/95/7637/global-type-1-diabetes-mellitus-market-value-will-exceed-7-bn-by-2021.html https://biospectrumindia.com/features/95/7637/global-type-1-diabetes-mellitus-market-value-will-exceed-7-bn-by-2021.html Thu, 26 Nov 2015 14:01:49 +0530 The Type 1 Diabetes Mellitus (T1DM) market across the eight major countries of the US, Canada, France, Germany, Italy, Spain, the UK and Japan will expand from $4.2 billion in 2014 to $7.1 billion by 2021, at a robust Compound Annual Growth Rate (CAGR) of 7.9%, according to business intelligence provider GBI Research. According to the company's latest report, this rise will be driven by the uptake of recently approved and pipeline premium products, as well as the rapidly expanding treatment population, which is attributable to the increasing incidence of T1DM, as well as the fact that patients are being diagnosed at younger ages and living longer due to improved treatment options. Ms Fiona Chisholm, Analyst for GBI Research, says that while the T1DM market faces the threat of considerable biosimilar erosion over the forecast period, owing to recent and upcoming patent expirations for several of the leading insulin brands, such as Sanofi's Lantus, Eli Lilly's Humalog and Novo Nordisk's Levemir and Novolog, there are reasons to be optimistic. She comments: "Despite this apparent market vulnerability, all of these companies have strong pipeline products in development, and will therefore maintain their positions as dominant players in T1DM over the forecast period. "Indeed, technological advances in recent decades have led to the development of improved exogenous insulin therapies, capable of mimicking endogenous insulin activity more effectively. As such, there are several promising insulin products in development, including Novo Nordisk's NN-1218 and Eli Lilly's insulin peglispro." GBI Research has also identified a strong trend in the pipeline for the development of non-insulin therapies, including adjuvant therapies capable of reducing hyperglycemia in an insulin-independent manner, and products attempting to disrupt the pathological immune-mediated destruction of pancreatic beta cells. Ms Chisholm continues: "Several of the adjuvant therapies are in late-stage drug development and have demonstrated strong clinical profiles. The emergence of such treatments will drive strong market growth over the forecast period. "Additionally, products disrupting the destruction of pancreatic beta cells are likely to have a greater impact on the T1DM treatment algorithm over the longer term." ]]> <![CDATA[Teva, Heptares to co-develop migraine treatment ]]> https://biospectrumindia.com/news/95/7636/teva-heptares-to-co-develop-migraine-treatment-.html https://biospectrumindia.com/news/95/7636/teva-heptares-to-co-develop-migraine-treatment-.html Thu, 26 Nov 2015 11:21:17 +0530 Teva Pharmaceutical Industries and Heptares Therapeutics announce that they have entered into a licensing and drug-discovery agreement under which Teva will receive exclusive global rights to develop, manufacture and commercialize novel, small-molecule calcitonin gene-related peptide (CGRP) antagonists discovered by Heptares for the treatment of migraine. Under the terms of the agreement, Heptares will receive an upfront payment of $10 million, research funding, and is eligible to receive additional research, development and commercialization milestone payments of up to $400 million. In addition, Heptares will be eligible to receive royalties on net sales of products resulting from the alliance. "We are delighted to begin this partnership with Heptares, which through its industry-leading, structure-based design approach has generated novel CGRP antagonists with significant promise for treating migraine," said Dr Michael Hayden, president of global R&D and chief scientific officer at Teva. "CGRP antagonism represents an exciting opportunity to treat migraine. We believe small-molecule CGRP antagonists offer further opportunities that are highly complementary to our promising candidate, TEV-48125, an anti-CGRP antibody." "This agreement is an exciting development for our CGRP antagonist program," said Mr Malcolm Weir, CEO, Heptares. "Teva brings world-leading clinical and commercial expertise in migraine to advance this program based on differentiated small-molecule CGRP antagonists discovered using our novel structure-based drug design technologies. The commitment Teva is making allows us to expand this promising program." ]]> <![CDATA[Infosys Prize 2015 winner: 'Drug development is a long and expensive road']]> https://biospectrumindia.com/interviews/95/8458/infosys-prize-2015-winner-drug-development-is-a-long-and-expensive-road.html https://biospectrumindia.com/interviews/95/8458/infosys-prize-2015-winner-drug-development-is-a-long-and-expensive-road.html Thu, 26 Nov 2015 11:17:00 +0530 He was awarded the prestigious Infosys Prize 2015 in Life Sciences for his outstanding contributions in deciphering the molecular structure, at the atomic level, of key proteins involved in the biology of pathogenesis of malarial parasite. His work on the deadly malarial parasite has the potential value for vaccine design, and development of therapeutics for malaria. Dr Sharma holds a PhD from Northwestern University, USA, in Protein Crystallography, and a post-doctoral from Oxford University, UK, in Structural Biology. In his exclusive interview with BioSpectrum's Raj Gunashekar, he touches upon his award-winning research work, his passion for photography and ornithology, tackling R&D challenges, funding opportunities, and India's optimistically changing research landscape. Excerpts: Q: Firstly, a big congratulations Dr Sharma. What were your initial thoughts when you first heard that you were a winner of the coveted Infosys Prize? A: Thank you. I was very surprised to hear about the award via a phone call from Infosys Science Foundation. I shared it with my mother and rest of the family who were all elated. I feel deeply honored by this prize, and with gratitude thank all who have supported me over the past 15 years in India. Q: Tell us about your award-winning work on the malaria parasite proteins. A: I established a laboratory in ICGEB 15 years ago on the theme of understanding key malaria parasite proteins from a structural biology perspective. Specifically, human malaria parasites like P falciparum have evolved specific protein families that are dedicated to assist a parasitic lifestyle. Most malaria parasite proteins of intense interest from basic and translational biology perspective are additionally complex because of their peculiar amino acid composition. This feature has been very challenging to us and others; however we stuck to our focus of tackling these difficult proteins and making them amenable for structural and biochemical studies. In addition, we decided to focus on proteins that would enlighten vaccine development, or allow new targets for drug discovery. Indeed, for modern vaccine validation and design, a structural underpinning is critical in context of complex parasitic (or viral) proteins. Our thrusts on these topics would not have been possible without extensive and highly enriching collaborations within ICGEB, India, and internationally. Over the past 6 years, we have been able to make a very pressing case for inclusion of protein translation enzymes as new drug targets, not only in malaria drug discovery themes but also in many related pathogenic diseases. We feel that sustained focus on this framework of progress will enable discovery and development of next-generation anti-malarials and anti-pathogenics. Q: How do you intend to commercialize your research? A: We have established very robust systems for drug screening against specific, high-value targets in malaria parasites. In linkages with medicinal chemists, we are further developing some of the anti-malarial compounds. Drug development is a road that is long and expensive to travel on, and therefore it will be premature to speculate on commercialization. Q: You have extensively worked abroad in research and teaching. What are the major differences between the West and India in this? A: I think it is time to discuss this issue in context of specific institutions in the West and India. Indeed, it is not the stereotypical West versus India debate anymore. We in India have several very high-quality institutions of great repute, replete with tremendously talented scientists. And, not all institutions in the West have cutting-edge academic and research capabilities like some in India. Indeed, in modern times, scientific excellence is a worldwide phenomenon. Human ingenuity cannot be beholden to geographical boundaries. I have been very lucky to spend time in multiple countries, amongst institutions that excel in their respective domains. Within the establishments that I have been associated with, whether abroad or in India, the academic cultures are not very different. Q: Any suggestions to bolster R&D in India? A: Success in R&D depends on three critical factors to my understanding. First is the scientific and technical talent, where India is already very rich. Second is the organizational ability, where again, India has achieved remarkable integration over the past many decades, and most logistical and governance structures are in place. The third critical component is funding. Here, besides an increased support from the government, India can consider enhanced engagement with philanthropists and the private sector. Q: Do you think scientists can also become successful entrepreneurs in our country? Explain. A: Yes, indeed. Any individual with ideas, drive and vision is capable of successful entrepreneurship. My first PhD student, upon completion of his doctoral work, had post-doctoral offers from many renowned institutions. He however moved away from basic science, and launched a biotechnology company in Hyderabad, and is now a very successful entrepreneur. There are several other examples of such successes. I feel that these sporadic inspirations have to be channeled and mentored properly. It may be useful to provide option of at least one business/entrepreneurship academic course in various doctoral programs, so that young academicians are able to nourish their entrepreneurship inclinations and skills. Q: Most scientists and researchers speak of funding paucities in Life Sciences R&D in the country. What's your take on this? A: I agree with most scientists on this issue, which is incidentally a worldwide gripe. However, if one takes a longer-term view of funding for bioscience in India, the scenario has been very positive. Over the past 3 decades, science funding has gone up significantly, and specifically since late 90's there has been notably stronger investment from the government. At the present moment, the fiscal situation is not very rosy worldwide, and during such times science along with perhaps arts suffer for funding. As the national and international economies rebound, we hope that more funds will be available for everyone. I am also of the view that R&D must try and attract greater funding from philanthropic organizations and individuals within India. Q: Is it risky to be a scientist given the long periods for research along with uncertain funding woes? A: 'Risky' is a word I associate with professions which our brave brothers and sisters choose when they join national forces in India's defense. From that perspective, the risks taken by almost any other profession seem feeble. In my view, scientists have the privilege of following their passion while being employed. Their long periods offer chance for relentless dedication, and vagaries of funding present windows of opportunity to diversify. Q: What are the attributes needed to become a successful researcher or a scientist? A: Perseverance. Q: What made you to return to India? A: To be amongst my family and friends in a place where I had a sense of belonging. Q: How do you balance both professional and personal life? A: I am surrounded by bands of highly loyal and supportive people, both in my professional and personal life. This makes me not only lucky but also allows me to have seamless transition between the two. Q: Tell us about your hobbies. A: Over a sustained period of time I would say that I have been very loyal to photography, art-house cinema and music (guitar). I live in deep awe of nature, admire all plant and animal life, and lately have been indulging in ornithology. Q: What would you attribute to the person that you are and the achievements that you have made? Any fond childhood memories or strong influences that you have had in your early days? A: I have had a privileged childhood and upbringing, where essentially all decisions - big and small - were made by me, whimsically or otherwise. I was exposed to a very liberated, highly-academic, secular and scientific home environment that I feel was critical in my development. I also had tremendous mentorship during my 5 years in Oxford University. Looking back, I feel lucky that I have had exposure to pluralistic and international educational institutions. Q: What message do you have to all the students who are dreaming of becoming a scientist or even are at a crossroad whether to become one? A: If one wants to sustain their intellectual flame ad infinitum, then science is the path. ]]> <![CDATA[Global Gaucher Disease treatment market to reach $1.16 bn by 2024]]> https://biospectrumindia.com/features/95/6959/global-gaucher-disease-treatment-market-to-reach-1-16-bn-by-2024.html https://biospectrumindia.com/features/95/6959/global-gaucher-disease-treatment-market-to-reach-1-16-bn-by-2024.html Wed, 25 Nov 2015 14:32:12 +0530 Sales of Gaucher disease therapeutics will rise gradually from $875 million in 2014 to $1.16 billion by 2024 across the seven major markets (7MM) of the UK, Italy, Spain, France, Germany, the US and Israel, at a Compound Annual Growth Rate (CAGR) of 2.9%, according to research and consulting firm GlobalData. The company's latest report states that while a lack of drugs in late-stage development will limit the expansion of the Gaucher disease treatment market by 2024, growth will be driven by an increase in the number of diagnosed prevalent Gaucher disease cases, meaning the treated population is rising. Dr Edit Kovalcsik, GlobalData's Analyst covering Cardiovascular and Metabolic Disorders, comments: "This increase can be attributed to continued efforts by Genzyme and Shire to raise awareness of such a rare condition as Gaucher disease. "It can also be credited to new screening programs, such as the lysosomal storage disorder new-born screening program introduced in the state of Missouri." The analyst adds that despite the anticipated improvements in diagnosis and treatment, a large portion of the Gaucher disease population will go untreated over the forecast period, due to continued late diagnosis and misdiagnosis of Gaucher disease as a result of its heterogeneous manifestations. Interestingly, the country that will experience the most substantial market growth is Israel, which will see an impressive CAGR of 8.4% over the forecast period, despite holding a more modest market share than the rest of the 7MM. Dr Kovalcsik explains: "The substantially faster growth in the Israeli Gaucher disease market compared with the US and the European markets will be driven by the greater increase in the diagnostic rate due to a high level of disease awareness in Israel among both physicians and the general public. "An increase in the treatment rate in Israel, which is currently much lower compared with the other regions in the 7MM, will also contribute to the growth of Israeli Gaucher disease drug sales." ]]> <![CDATA[Lupin receives FDA approval for Generic Loestrin 24 Fe Tablets]]> https://biospectrumindia.com/news/95/7752/lupin-receives-fda-approval-for-generic-loestrin-24-fe-tablets.html https://biospectrumindia.com/news/95/7752/lupin-receives-fda-approval-for-generic-loestrin-24-fe-tablets.html Wed, 25 Nov 2015 14:31:32 +0530 Pharma Major Lupin has announced that it has received final approval for its Blisovi 24 Fe Tablets (Norethindrone Acetate and Ethinyl Estradiol Tablets USP, 1 mg/0.02 mg and Ferrous Fumarate Tablets, 75 mg) from the United States Food and Drug Administration (US FDA) to market a generic version of Loestrin 24 Fe Tablets (Norethindrone Acetate and Ethinyl Estradiol Tablets USP, 1 mg/0.02 mg and Ferrous Fumarate Tablets, 75 mg). Lupin's US subsidiary, would commence promoting the product shortly in the US. Lupin's Blisovi 24 Fe Tablets (Norethindrone Acetate and Ethinyl Estradiol Tablets USP, 1 mg/0.02 mg and Ferrous Fumarate Tablets, 75 mg) are the AB rated generic equivalent of Warner Chilcott's Loestrin24 Fe Tablets (Norethindrone Acetate and Ethinyl Estradiol Tablets USP, 1 mg/0.02 mg and Ferrous Fumarate Tablets, 75 mg). It is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Loestrin 24 Fe had US sales of $56.8 million (IMS MAT June 2015). ]]> <![CDATA[Novartis' heart failure drug receives EU approval]]> https://biospectrumindia.com/news/95/7947/novartis-heart-failure-drug-receives-eu-approval.html https://biospectrumindia.com/news/95/7947/novartis-heart-failure-drug-receives-eu-approval.html Wed, 25 Nov 2015 10:46:47 +0530 Novartis has announced that the European Commission (EC) has approved Entresto (sacubitril/valsartan) for the treatment of adult patients with symptomatic chronic heart failure with reduced ejection fraction (HFrEF). Entresto is a twice a day tablet and has a unique mode of action which is thought to reduce the strain on the failing heart. The approval is based on results from the 8,442-patient PARADIGM-HF study in patients with HFrEF, which was stopped early when it was shown Entresto significantly reduced the risk of cardiovascular death versus ACE-inhibitor enalapril. At the end of the study patients who were given Entresto were more likely to be alive and less likely to have been hospitalized for heart failure than those given enalapril. Analysis of safety data showed that Entresto had a similar tolerability profile to enalapril. "We know that people living with heart failure face a high risk of death and have a worse quality of life than those with almost any other chronic condition, so it is very meaningful for HFrEF patients in Europe that we're able to offer a new first in class treatment option," said Mr David Epstein, division head, Novartis Pharmaceuticals. ]]> <![CDATA[Pfizer & IIT Delhi tie up, announce Innovation & IP Program for health innovators]]> https://biospectrumindia.com/news/95/6279/pfizer-iit-delhi-tie-up-announce-innovation-ip-program-for-health-innovators.html https://biospectrumindia.com/news/95/6279/pfizer-iit-delhi-tie-up-announce-innovation-ip-program-for-health-innovators.html Wed, 25 Nov 2015 10:06:27 +0530 Pfizer together with IIT Delhi has announced the launch of 'The Pfizer IIT-Delhi Innovation and IP Program', an incubation accelerator initiative co-created by Pfizer and the Foundation for Innovation and Technology Transfer (FITT) at the Indian Institute of Technology, Delhi (IIT-Delhi). The Program will be open to Indian nationals - individuals and startup companies - and comprises two components. For innovators seeking comprehensive support to translate their healthcare ideas into patents, the program will provide two years of residential incubation at IIT Delhi, funding of up to Rs 50 lakh for each innovator, mentoring support from IIT Delhi's faculty, access to infrastructure and prototyping laboratories, IP search and filing services, guidance from Pfizer's global experts, and access to venture capitalists and other industry linkages. For innovators who already have a ready proof of concept and are seeking to obtain a patent, the Program will provide access to IP attorneys and services and cover the patent fee. As per Pfizer, its funding through this program will be unencumbered. All rights on the innovations will be owned entirely by the innovators and they will be free to commercialize their patents as they desire. Speaking at the launch event on November 24, 2015, Mr S Sridhar, executive director, Pfizer India said, "Pfizer promotes a culture of innovation and encourages this creative endeavour globally. Our Innovation and IP Program with IIT Delhi will promote, celebrate and reward innovations and advancements in healthcare that are born and brought up in India for the benefit of our people. In doing so, our effort aligns with the Government's stated priority of creating a vibrant innovation ecosystem in the country and enhances the creation of intellectual property. I invite innovators in India to take advantage of this program and bring their healthcare inventions to life." Mr Amitabh Kant, secretary, Department of Industrial Policy and Promotion (DIPP), the Guest of Honour at the launch, said, "Nurturing entrepreneurship and innovation is a priority for India. In a knowledge economy, our success will be determined by the place we hold on the global innovation platform. I congratulate Pfizer and IIT Delhi on forging this partnership that will fuel indigenous innovations in the country. The Government is taking decisive steps to further enhance the innovation ecosystem in India and we welcome the participation of all stakeholders in this effort." The Foundation for Innovation and Technology Transfer is a well-established and recognized technology incubator that has been IIT Delhi's industrial interface organization since 1992. FITT operates the incubation facilities on the campus through which a large number of successful innovations have been created and commercialized. FITT will implement all stages of the Pfizer IIT Delhi Innovation and IP Program - from inviting proposals, to reviewing, shortlisting and selecting innovators and awarding appropriate grants. "IIT Delhi has a proud record of nurturing innovation and entrepreneurship. FITT and IIT Delhi have been the hotbed for innovations - helping entrepreneurs converts their ideas into intellectual property and successful business models. Through this partnership with Pfizer, we will provide access to resources and knowledge that would significantly increase the innovators' chances of creating novel healthcare solutions and successful commercial enterprises," said Dr Anil Wali, managing director, Foundation of Innovation and Technology Transfer, IIT Delhi. The Program will invite two rounds of proposals during the year 2015-2016. Call for proposals for the first round will open from November 27, 2015 until January 15, 2016. Applicants can submit their proposals on the FITT website. An independent panel of subject matter experts established by FITT will review and shortlist the potential incubatees. The Technology Business Incubator Unit board at IIT Delhi will make the final selection of individuals and start-ups that that shall receive the grants and be incubated at IIT Delhi. ]]> <![CDATA[Sanofi Pasteur reveals its research on a 'Universal' Influenza vaccine]]> https://biospectrumindia.com/news/95/6895/sanofi-pasteur-reveals-its-research-on-a-universal-influenza-vaccine.html https://biospectrumindia.com/news/95/6895/sanofi-pasteur-reveals-its-research-on-a-universal-influenza-vaccine.html Tue, 24 Nov 2015 17:01:16 +0530 The World Vaccine Congress in Europe is in its 16th year and is a major destination for vaccine leaders to share developments in the field. "As the world's leader in the production of influenza vaccines, Sanofi Pasteur's ambition is to drive innovation and to shape the future by exploring several of the leading influenza vaccine strategies," according to Mr Olivier Charmeil, President and CEO of Sanofi Pasteur, the company that supplied over 220 million doses of seasonal influenza vaccines in 2014. At the World Vaccine Congress, Dr Harry Kleanthous, Associate VP for Research discussed the paradigm shifting potential of broader-spectrum influenza vaccine approaches that stimulate protection against many influenza strains, unlike the current licensed vaccines that are designed to protect against 3-to-4 strains that are determined before the influenza vaccine production process begins each year. "We are actively exploring the development of a more-broadly protective influenza vaccine that will be designed to prevent the seasonal mismatches that can occur and that are not addressed using the current technology," explained Dr Kleanthous. "They are complementary but can be considered 'tailored' antigens in that they are designed to re-focus the immune response to key protective epitopes on the hemagglutinin, which is the active component of our currently licensed influenza vaccines," he continued. "These antigens are still a key player in any flu vaccine, since antibodies directed against them are responsible for preventing the Flu virus from binding to and infecting the cell. Creating new antigens is a central theme in our strategy." Sanofi Pasteur has an existing R&D collaboration agreement with the University of Georgia on a method that - according to Dr Kleanthous - could yield a novel, synthetic vaccine based on the hemagglutinin protein, designed to protect against seasonal influenza strains spanning several years, including drifted strains not yet in existence. Traditional influenza vaccine manufacturers are directed by, and provided with candidate vaccine viruses from public-health authorities determined through active surveillance of influenza viruses circulating each year. Sanofi Pasteur's experimental vaccine is a novel synthetic vaccine generated from key genetic sequences of many flu viruses, and is termed 'computationally optimized broadly reactive antigen' or COBRA, and is designed to protect against many strains over several years, due to the common sequences many flu viruses share. The key advantage is broader coverage against several seasonal flu strains, which is important when there is a mismatch to the vaccine strain. An additional advantage of this approach is not relying upon annual strain selection, allowing year-round manufacturing. "We are working with one of the leading infectious disease researchers from the University of Georgia, Dr Ted Ross, who is currently engineering COBRA vaccines based on past sequences to cover as many strains as possible and to maximize the immune response to an influenza vaccine," said Dr Kleanthous. "We need to find common elements that don't change every year; study how influenza vaccines have performed in the past, testing what's immunologically relevant for a broader-spectrum influenza vaccine. Improved influenza vaccines such as COBRA--designed to protect against drifting and co-circulating viruses, as well as other antigens that induce complimentary mechanisms of protection--are anticipated to have a significant impact on strain coverage and vaccine effectiveness," the researcher concluded. According to Sanofi Pasteur's Senior Vice President for R&D, Dr John Shiver, a universal flu vaccine will need to be compared against the standard-of-care (seasonal vaccines), showing safety, comparable immunogenicity, and efficacy in human clinical trials over several years against a range of influenza virus strains. "A truly universal vaccine is the ultimate goal; however, we believe that a broader-spectrum vaccine will be available first to replace the current seasonal flu vaccine given annually," he explained. "Science, including vaccine R&D, tends to be an iterative process. It's an evolution." ]]> <![CDATA[QEPrize winner Dr Langer from MIT speaks exclusively to BioSpectrum]]> https://biospectrumindia.com/interviews/95/7414/qeprize-winner-dr-langer-from-mit-speaks-exclusively-to-biospectrum.html https://biospectrumindia.com/interviews/95/7414/qeprize-winner-dr-langer-from-mit-speaks-exclusively-to-biospectrum.html Tue, 24 Nov 2015 16:14:31 +0530 Dr Robert Samuel Langer was awarded the 2015 Queen Elizabeth Prize (QEPrize) for Engineering in February 2015 at the Royal Academy of Engineering, London, UK. He is a world-renowned American scientist, engineer, inventor and entrepreneur, and David H Koch Institute Professor at the Massachusetts Institute of Technology (MIT), USA. The award is a global £1 million prize celebrating pioneering innovations that has had a profound benefit to humanity globally. Dr Langer lab's work is at the interface of biotechnology and materials science. His lab's major focus is in studying and development of polymers to deliver drugs, particularly genetically-engineered proteins, DNA and RNAi, continuously at controlled rates for prolonged periods of time. Dr Langer exclusively spoke to BioSpectrum's Raj Gunashekar, where he shares his passion origins, memories of his childhood laboratory, entrepreneurial tips and his award-winning work on controlled-release drug systems. Excerpts: Q: Firstly, a hearty congratulations Dr Langer. Tell us about your award-winning work to our Indian readers, and the impact of your controlled-release drug systems. A: Thank you Raj. I think engineering is such a wonderful way to contribute to society. The two things that give me the greatest satisfaction are discovering principles or making inventions that enable people to have happier and healthier lives, and seeing the people who train in our lab succeed to become future leaders in engineering themselves. There are times when drugs administered to patients could react after being in the system for more than the required period of time or they might be ineffective by disappearing quickly. To tackle this, controlled drug release helps maintain and sustain the drug release at an effective level for the suitable period of time. The polymer which was invented through my study helps in controlled dissemination of the drug molecules. My work which won the QEPrize is on engineered polymers which control the delivery of large molecular weight drugs for the treatment of diseases such as cancer and mental illness. It is already being used in various countries, including India. I am thrilled to be the recipient of the Queen Elizabeth Prize 2015. The prize celebrates ground-breaking innovations in engineering and in addition strives to celebrate stories of engineering successes, raising the international public profile of engineering and inspiring new generations of engineers to take up the challenges of the future. Q: What sparked you to become a scientist? A: Some of it started as a child having chemistry, microscope and erector sets. My dad also played a lot of math games with me. All this contributed to my liking science and math. Q: Shed some light about the lab in your home's basement in Albany (USA). A: It was a small basement and I had a Gilbert chemistry set. I put all the chemicals down there and I loved doing experiments where I would make things like rubber and make solutions change colors via chemical reactions. Q: You have a background in Chemical Engineering. What made you to shift towards Biomedical Engineering? A: I always wanted to learn biology. My PhD thesis was on the enzymatic regeneration of ATP. I did my postdoc in a surgery lab at Boston's children's hospital. I was the only engineer in the hospital. It really gave me all kinds of ideas as to how chemical engineering could be applied to medicine. Q: You have been researching since the 70s. How difficult or hard has it been for you to achieve what you have achieved today? Were there any major obstacles or set-backs? How did you overcome them? A: Very difficult. My first nine research grants were turned down largely because my research went against conventional wisdom. No chemical engineering department would hire me as a professor. And I ended up joining a nutrition department. The year after I joined, the department head who hired me left. So the associate department heads decided to give me advice. They told me to start looking for another job. Time helped me overcome some of these issues as we proved that conventional wisdom was incorrect. And I just never gave up. Q: You have over one-thousand patents to your credit. How will you define innovation? A: A new idea or invention, and its implementation into real life Q: You are also an entrepreneur too. What do you have to say to all the scientists who want to be an entrepreneur? A: I think it's an attractive career path but not the only career path. Personally I love it because it enables myself and my students to take our ideas into the real world and help people. But science leads to many good career paths. Q: What are the common mistakes committed by scientists while they pursue their entrepreneurial dreams? A: Starting a company too early. Not having good intellectual property (IPs). Q: What do you advice students who hesitate to become a scientist or pursue a research-oriented career? A: I think that's okay. Everyone should get lots of advice. But they should follow their passion. I think people should do things that make them happy. And they shouldn't do things just to make money. Q: As an entrepreneur, why do you think start-ups fail at times? A: Starting too early, having a poor CEO and poor investors. Q: Who or what do you attribute your success to? A: Great mentors, learning something about 2 very disparate fields - engineering and medicine, and perseverance Q: You head the world's largest Biomedical Lab at MIT. You may have had the chance to work with Indian scientists too. Tell us about your experience working with them. A: They have been wonderful. Many of my Indian trainees are top professors in both the US and India. Some head top companies. Q: Your final take-home message to our readers. A: For young people, I'd say dream big dreams, dreams that can change the world and make it a better place. Many times you will run into obstacles, but don't give up on those dreams. ]]> <![CDATA[Health Ministry along with UNICEF launched its campaign to fight Hepatitis B]]> https://biospectrumindia.com/news/95/6860/health-ministry-along-with-unicef-launched-its-campaign-to-fight-hepatitis-b.html https://biospectrumindia.com/news/95/6860/health-ministry-along-with-unicef-launched-its-campaign-to-fight-hepatitis-b.html Tue, 24 Nov 2015 15:44:40 +0530 Ministry of Health and Family Welfare along with UNICEF kick started a campaign to eradicate Hepatitis B from the country with Amitabh Bachchan as the goodwill ambassador here in Mumbai on Monday. The event which launched awareness videos was inaugurated by J P Nadda, Union Minister of Health and Family Welfare. While Deepak Sawant, state health minister, expressed the commitment of Maharashtra government towards the campaign, Louis Georges Arsenault, UNICEF Representative to India, promised its support to fight with Hepatitis B. Of the 26 million infants born every year in India, approximately 1 million run the life time risk of developing chronic HBV carriers. In India, introduction of HBV vaccine was pilot-tested in 14 cities and 33 districts in 2002-03; extended to ten states in 2007-08 and the immunization was expanded to the entire country in 2011-12. Government of India has included HBV vaccine in the National universal immunization program in the entire country in 2011-12. The Pentavalent vaccine that included hepatitis B and Haemophilus influenzae in addition to diphtheria, pertussis, and tetanus was initially tried in a pilot study in Kerala and Tamil Nadu. After encouraging results, the program was extended to the states of Goa, Gujarat, Haryana, Jammu and Kashmir, Karnataka, Kerala, Puducherry, and Tamil Nadu. 12 more states were extended in 2014 and rest of states would be covered by the end of 2015. J P Nadda, Union Health and Family Welfare Minister, said "It is the government's mission to avoid all deaths caused by preventable diseases. Mission Indradhanush targets full immunization coverage to be expanded from 65% to at least 90% children of the country, which includes 7 vaccines for diseases including Hepatitis B. There will be four more vaccines in the list soon. The government with these campaigns wants to ensure the health of a citizen in his full life cycle. We are particularly targeting those are left out and to ensure the quality of vaccines by maintaining the sophisticated cold chains. Indian government is conducting 90 lakh campaigns for immunization and 7 crore vaccine doses are given." Louis Georges Arsenault, UNICEF Representative to India, said "India as a country has a good track record in immunization and reaching out people for vaccination, including in the case of Polio. We believe with timely Immunization of children, the country can be made completely free of Hepatitis B very soon. Preventing Hepatitis-B through immunization at birth and the first year of life is critical for the healthy life of a child." ]]> <![CDATA[Mankind launches low-price anti-diabetic drug-Gliptin]]> https://biospectrumindia.com/news/95/7065/mankind-launches-low-price-anti-diabetic-drug-gliptin.html https://biospectrumindia.com/news/95/7065/mankind-launches-low-price-anti-diabetic-drug-gliptin.html Tue, 24 Nov 2015 14:05:51 +0530 Mankind Pharma has launched anti-diabetic product Dynaglipt (Teneligliptin) for the diabetic patients of India targeting the middle class and rural diabetic patients of India so as to cater to this growing epidemic. The company has recently launched this advanced oral anti- diabetic drug as approved by Drug Controller General of India that produces sustained blood glucose control after all three meals and is also safe even in diabetic patients with kidney disease. This molecule comes under the category of DPP-4inhibitors. As per IDF (International Diabetes Federation) there were more than 7 crores diabetic patients in India for the year 2014 and this figure will rise significantly to 11 crores. As most of the patient population resides in rural India or belong to middle class. Dynaglipt, is the latest new generation oral anti-diabetic drug manufactured by Mankind which has received regulatory approval and is priced at nearly Rs 600 for 30 days therapy to a patient. Furthermore, this gliptin tablet is required to be taken or consumed just once in a day as compared to other diabetic drugs which are required to be taken after every meals. One dose itself, provides blood glucose control after all three meals. Commenting on the launch, Mr. R.C Juneja, Chairman & Founder, Mankind Pharma said that"Currently there are 1.9 million of the 62 million diabetic patients in India who are estimated to be on gliptin therapy. Dynaglipt as an anti-diabetic drug by Mankind Pharma is most affordable Gliptin with unique advantages and availability all across India and will definitely bring delight for millions of diabetic patients in India. Also, this molecule could help bring down the cost of medicines by approx. 50%." Mankind aims to achieve revenue of Rs. 4200 crore this year, with the launch of Dynaglipt the diabetes segment of Mankind Pharma will contribute 200 Cr to the revenue. ]]> <![CDATA[Mega Merger: Pfizer and Allergan to combine]]> https://biospectrumindia.com/news/95/7223/mega-merger-pfizer-and-allergan-to-combine.html https://biospectrumindia.com/news/95/7223/mega-merger-pfizer-and-allergan-to-combine.html Tue, 24 Nov 2015 10:50:09 +0530 Pfizer and Allergan has announced that their boards of directors have unanimously approved, and the companies have entered into, a definitive merger agreement under which Pfizer will combine with Allergan in a stock transaction currently valued at $363.63 per Allergan share, for a total enterprise value of approximately $160 billion. "The proposed combination of Pfizer and Allergan will create a leading global pharmaceutical company with the strength to research, discover and deliver more medicines and therapies to more people around the world," stated Mr Ian Read, chairman and CEO, Pfizer. "Allergan's businesses align with and enhance Pfizer's businesses, creating best-in-class, sustainable, innovative and established businesses that are poised for growth. Through this combination, Pfizer will have greater financial flexibility that will facilitate our continued discovery and development of new innovative medicines for patients, direct return of capital to shareholders, and continued investment in the United States, while also enabling our pursuit of business development opportunities on a more competitive footing within our industry." "The combination of Allergan and Pfizer is a highly strategic, value-enhancing transaction that brings together two biopharma powerhouses to change lives for the better," said Mr Brent Saunders, CEO, Allergan. "This bold action is the next chapter in the successful transformation of Allergan allowing us to operate with greater resources at a much bigger scale. Joining forces with Pfizer matches our leading products in seven high growth therapeutic areas and our robust R&D pipeline with Pfizer's leading innovative and established businesses, vast global footprint and strength in discovery and development research to create a new biopharma leader." Under the terms of the proposed transaction, the businesses of Pfizer and Allergan will be combined under Allergan plc, which will be renamed "Pfizer plc." The companies expect that shares of the combined company will be listed on the New York Stock Exchange and trade under the "PFE" ticker. Upon the closing of the transaction, the combined company is expected to maintain Allergan's Irish legal domicile. Pfizer will have its global operational headquarters in New York and its principal executive offices in Ireland. As a result of the combination with Allergan and subsequent integration of the two companies, Pfizer now expects to make a decision about a potential separation of the combined company's innovative and established businesses by no later than the end of 2018. The completion of the transaction, which is expected in the second half of 2016, is subject to certain conditions, including receipt of regulatory approval in certain jurisdictions, including the United States and European Union, the receipt of necessary approvals from both Pfizer and Allergan shareholders, and the completion of Allergan's pending divestiture of its generics business to Teva Pharmaceuticals, which Allergan expects will close in the first quarter of 2016. Pfizer plc's board is expected to have 15 directors, consisting of all of Pfizer's 11 current directors and 4 current directors of Allergan. The directors from Allergan will be Mr Paul Bisaro, Allergan's current executive chairman, Mr Brent Saunders, Allergan's current CEO, and two other directors from Allergan to be selected at a later date. Mr Ian Read will serve as chairman and CEO of the combined company. Mr Brent Saunders will serve as president and chief operating officer of the combined company. He will be responsible for the oversight of all Pfizer and Allergan's combined commercial businesses, manufacturing and strategy functions. Guggenheim Securities, Goldman, Sachs & Co., Centerview Partners and Moelis & Company are serving as Pfizer's financial advisors for the transaction, with Wachtell, Lipton, Rosen & Katz, Skadden, Arps, Slate, Meagher & Flom LLP and A & L Goodbody acting as its legal advisors. JP Morgan and Morgan Stanley are serving as Allergan's financial advisors for the transaction with Cleary Gottlieb Steen & Hamilton LLP, Latham & Watkins LLP and Arthur Cox acting as its legal advisors. ]]> <![CDATA[Govt launches major initiative to track disease burden ]]> https://biospectrumindia.com/news/95/6554/govt-launches-major-initiative-to-track-disease-burden-.html https://biospectrumindia.com/news/95/6554/govt-launches-major-initiative-to-track-disease-burden-.html Mon, 23 Nov 2015 15:11:45 +0530 India has been going through a major epidemiological transition over the past 25 years. The burden of premature death and health loss due to non-infectious conditions such as heart disease, stroke, diabetes, chronic obstructive lung disease and road traffic has increased massively, and the burden due to lower respiratory infections, tuberculosis, diarrhea and neonatal disorders still remains unacceptably high. The Indian Council of Medical Research (ICMR), the Public Health Foundation of India (PHFI) and the Institute for Health Metrics and Evaluation (IHME) at the University of Washington under the aegis of Ministry of Health and Family Welfare, Government of India have launched a collaborative initiative on state-level disease burden estimation in India. In this effort, the robust methods of the Global Burden of Disease (GBD) study, developed by a global network of researchers coordinated by IHME, will be utilized to generate rigorous estimates of all the major drivers of health loss at the state level in India. In addition to the scientific papers, the initiative will produce multilevel disseminations through policy-briefs, workshops and seminars to raise the discourse and monitor changing disease trends. State-of-the-art GBD interactive visualization tools will be used to bring to life the initiative's findings. This will allow a variety of contrasts between states, which will be particularly useful for policy makers in understanding trends of disease and risk factor in order to plan further action. This initiative would work closely with a network of academic partners across India, and importantly with policy makers at the national and state level for guidance and utilization of the findings to improve health programmes and planning. "There is substantial variation across India in disease burden trends which need to be systematically understood at sub-national levels. The need of the hour is to have a robust scientific approach to identify and estimate the significant contributors to ill-health across each state in order to plan a response specific to the local situation. This collaborative effort will be a first-of-its-kind that examines the extent, pattern, and trends of diseases and risk factors across the states of the country." said Dr Soumya Swaminathan, director-general of ICMR and secretary, health research, in the Government of India "The contribution of risk factors such as high blood pressure, blood sugar and cholesterol, and that of poor diet and alcohol use, to health loss has doubled in India over the past two decades, and air pollution and tobacco smoking continue to be major contributors to health loss. However, the extent of these risk factors varies considerably across the states of India. The efforts of the State-level Disease Burden Initiative would help refine the understanding of these variations across India, which would inform appropriate strategies for the different states of India," said Prof K Srinath Reddy, president of PHFI. "Many Indian states are bigger than most countries in the world. Planning for health improvements for one-sixth of the world's population living in India without accounting for variations in disease burden trends across the states cannot yield optimal outcomes. The collaborative effort of the State-level Disease Burden Initiative, which would involve a large variety and number of stakeholders in India, is a unique opportunity that would generate better evidence for the disease trend variations across India and also enable development of relevant data generation systems to inform health planning on an ongoing basis at local levels in India" said Prof Lalit Dandona, who will serve as the director of this joint initiative. IHME leads the Global Burden of Disease study which is a systematic scientific effort to quantify the comparative magnitude of health loss due to diseases, injuries and risk factors by age, sex and geographies for specific points in time along with measures of uncertainty. "GBD has about 1400 collaborators in more than 100 countries. Besides the country-level estimates, sub-national level estimates have recently been produced for China and UK as part of the GBD study, which are proving very useful in enhancing health planning in these countries at the local levels. Similarly, there is great potential to improve health in India through this collaborative initiative as it will facilitate action based on reliable estimates of disease burden and risk factors at the state level." said IHME director, Prof Christopher Murray, who leads the GBD study globally. This collaborative initiative is expected to contribute substantially to appropriate health policy and system development through production of reliable state-level disease burden estimates as well as improvement of systems to produce these estimates on an ongoing basis to monitor changing trends at the local levels. ]]> <![CDATA[Rajasthan farmer group writes to PMO to protect GM Mustard]]> https://biospectrumindia.com/news/95/7108/rajasthan-farmer-group-writes-to-pmo-to-protect-gm-mustard.html https://biospectrumindia.com/news/95/7108/rajasthan-farmer-group-writes-to-pmo-to-protect-gm-mustard.html Mon, 23 Nov 2015 14:09:13 +0530 On behalf of 14 crore farmers, Sir Chaudhary Chhoturam BKS, a farmer body of Rajasthan has sent a petition to PMO to protect the right of Indian farmers and give them a say in choosing the best agriculture technology. This letter comes after the recent attack on GM Mustard by anti GM activists. In the letter, BKS have shared their perspective on the false and negative allegations by anti-activist on GM Mustard and have emphasised on the fact that GM Mustard is going to be beneficial to the farming and agriculture community. In their letter to PMO, they have said that agriculture scenario in our country is already facing major challenges due to climate change, issues of small land holding and depleting soil fertility. All these challenges have led to an increase in farmer suicides across India. While India's food requirement increases, it is important for us to also continue to grow and create a higher self-reliance with regards to food-crops. As per research GM Mustard hybrid has the potential of increasing yield by 25 per cent higher. This 20-25 per cent higher yield comes without using a single extra grain of fertiliser or single extra drop of water. This is going to be beneficial for farmers of water deficient states of North and North West India. BKS further urged the PMO to give this technology a chance and banning trials is anti- science and country may loose out on the opportunity for second green revolution which is an integral part PM Modi`s better India dream. "The government had faced the similar problem 14 years back, when the approvals for BT Cotton were going on. Farmer yields in cotton have doubled in the last 10-12 years. Same may happen with new technologies in mustard too," the letter said. On the regulatory part, letter reads, "While BKS understand and agree that regulation and safety of GM Mustard is an important aspect and we should not simply put this technology in the farmer`s field. Therefore, trials are critical and should be followed without any compromise and the technology should only be implemented after an approval from regulators. As long as GM Mustard meets all bio safety norms, interest of farmers should not be compromised. GM Mustard will benefit the Indian farming community." BJP government has identified agriculture as an important area of focus. BKS has requested government's help, support and guidance to ensure that farmer well-being is protected and sustained. The letter concluded that as upholder of farmer`s right, BKS says it is ensuring that farmers have a right to choose the best technology that assures them higher return the organisation is open to have a broader discussion with these activities who are promoting a cause that is detrimental to growth of agriculture economy and community. ]]> <![CDATA[Mylan completes acquisition of certain businesses from Famy Care ]]> https://biospectrumindia.com/news/95/6755/mylan-completes-acquisition-of-certain-businesses-from-famy-care-.html https://biospectrumindia.com/news/95/6755/mylan-completes-acquisition-of-certain-businesses-from-famy-care-.html Mon, 23 Nov 2015 12:26:37 +0530 The acquisition is expected to be immediately accretive to Mylan's adjusted diluted earnings per share and Mylan's financial leverage is not materially altered as a result of this transaction. The transaction brings Mylan a broad women's care portfolio, strong technical capabilities and dedicated hormone manufacturing, which, when combined with Mylan's expansive global commercial footprint and supply chain infrastructure, will create a leading women's healthcare franchise. Mylan's CEO Ms Heather Bresch commented, "The completion of this transaction is an important milestone as we continue to grow our global women's healthcare franchise, and take another step in our mission to provide the world's 7 billion people access to high quality medicine. In addition to strengthening our women's healthcare offering in North America, we will continue to leverage our powerful commercial platform in Europe, now enhanced through our recent Abbott deal, to serve this important therapeutic area. "Moreover, we look forward to building upon our existing commercial presence in emerging markets by leveraging our global supply chain and operational excellence to further accelerate our growth. This will include building upon our existing women's care portfolio in India and expanding our reach in support of Family Planning 2020, a global partnership that aims to enable 120 million more women and girls to use contraceptives by 2020. "We also are excited to welcome nearly 1,000 dedicated employees to our family and look forward to their contributions as we strive to create better health for a better world, one person at a time." ]]> <![CDATA[Strides Shasun receives USFDA approval for Dutasteride Softgel Capsule]]> https://biospectrumindia.com/news/95/6294/strides-shasun-receives-usfda-approval-for-dutasteride-softgel-capsule.html https://biospectrumindia.com/news/95/6294/strides-shasun-receives-usfda-approval-for-dutasteride-softgel-capsule.html Mon, 23 Nov 2015 12:26:19 +0530 The product is ready for Day 1 launch, said Strides in a press release. Dutasteride is used to treat benign prostatic hyperplasia (BPH; enlargement of the prostate gland). The product has gone off patent on November 20, 2015, and Strides Shasun is amongst the first wave of generic players to receive this approval. The capsule is used to treat symptoms of BPH and may reduce the chance of developing acute urinary retention (sudden inability to urinate). The product may also decrease the chance that prostate surgery will be needed. The product will be manufactured at the company's oral dosage facility at Bangalore, and marketed by Strides Shasun in the US Market. According to IMS data, the US market for Dutasteride Capsules is approximately US $470 Million. ]]> <![CDATA[Zydus launches new diabetes drug in India]]> https://biospectrumindia.com/news/95/6295/zydus-launches-new-diabetes-drug-in-india.html https://biospectrumindia.com/news/95/6295/zydus-launches-new-diabetes-drug-in-india.html Mon, 23 Nov 2015 12:06:17 +0530 Zydus Cadila launches Tenglyn - Teneligliptin 20 mg tablets, which belongs to a new class of oral anti-diabetic agents, Gliptins. With an aim to make this important therapy affordable and accessible to diabetic patients, Tenglyn is being priced at just Rs 7 per tablet which is almost 1/6th the price at which the Gliptins were initially launched in India. Gliptins have shown promise in achieving glycemic control without deteriorating beta cell function and is one of the most recent advancements in diabetes care and management. Research in the field of anti-diabetic therapy seeks to address the problems of hypoglycemia, GI side effects, lactic acidosis, weight gain, CV risks etc., which pose a major challenge in the treatment of diabetes. Speaking on the development, Dr Sharvil Patel, deputy managing director, Zydus Cadila, said, "At Zydus, our endeavour has been to bring new therapies and innovations that address the two primary challenges in India of accessibility and affordability. Diabetes, as we know, is becoming a major health burden globally. We remain committed to this fight against diabetes and with Tenglyn we provide patients suffering from diabetes access to this advanced treatment at the most affordable cost." ]]> <![CDATA[Aurobindo Pharma gets FDA nod for new generic]]> https://biospectrumindia.com/news/95/6271/aurobindo-pharma-gets-fda-nod-for-new-generic.html https://biospectrumindia.com/news/95/6271/aurobindo-pharma-gets-fda-nod-for-new-generic.html Mon, 23 Nov 2015 12:05:51 +0530 Aurobindo Pharma Limited is pleased to announce that the company has received final approval from the US Food and Drug Administration (US FDA) to manufacture and market Sildenafil Tablets, 20 mg (ANDA 203963). This product is expected to be launched by Q4 FY 2015-16.] The approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) REVATIO sildenafil citrate) Tablets 20 mg of Pfizer. Sildenafil Tablets are used in the treatment of pulmonary arterial hypertension (high blood pressure in the lungs). The approved product has an estimated market size of $80 million for the twelve months ending September 2015 according to IMS. ]]> <![CDATA[AZ, Sanofi swap over 200,000 chemical compounds]]> https://biospectrumindia.com/news/95/6262/az-sanofi-swap-over-200000-chemical-compounds.html https://biospectrumindia.com/news/95/6262/az-sanofi-swap-over-200000-chemical-compounds.html Mon, 23 Nov 2015 12:05:21 +0530 The swap represents a novel open innovation model between pharmaceutical companies. It enhances the chemical diversity of the compound collections of both companies and allows each to screen a broader, more diverse chemical space as the starting point in the search for new small-molecule medicines. AstraZeneca and Sanofi have each selected the compounds to exchange based on differences from those in their own libraries. Chemical structures and synthetic procedures will be shared to facilitate the use of these compounds. The compounds will be exchanged in sufficient quantity to enable the receiving company to carry out high throughput screening for several years to determine whether they are active against specific biological targets. If a compound matches a target, it will go through several modifications to optimise its structure before being classified as a 'lead compound' to be taken forward to development. Dr Mene Pangalos, executive vice-president, Innovative Medicines and Early Development at AstraZeneca, said, "This is a highly innovative agreement which speaks to our open innovation approach. We've worked hard to enrich our compound library in recent years and this exchange, which is by far the largest we have achieved, enables us to significantly increase its diversity. Most importantly, it will accelerate our ability to identify unique starting points that could become new medicines for patients." Dr Elias Zerhouni, president, Global R&D at Sanofi, said, "Sanofi is committed to open innovation in our R&D platforms because we recognise that collaboration is the foundation of every medical breakthrough. We are happy to partner with other companies if it will speed the discovery of new life-saving or life-enhancing therapies for patients. We believe that this collaboration will increase our capacity to deliver innovative solutions that have the potential to add significant medical value and transform lives." There are no payments associated with the compound exchange. Each company can investigate the compounds it receives without restrictions on disease areas. ]]> <![CDATA[Dupilumab to drive global atopic dermatitis treatment market to $7.3 bn by 2024]]> https://biospectrumindia.com/features/95/8164/dupilumab-to-drive-global-atopic-dermatitis-treatment-market-to-7-3-bn-by-2024.html https://biospectrumindia.com/features/95/8164/dupilumab-to-drive-global-atopic-dermatitis-treatment-market-to-7-3-bn-by-2024.html Fri, 20 Nov 2015 13:52:00 +0530 The company's latest report states that this increase, which will occur across the seven major markets (7MM) of the US, France, Germany, Italy, Spain, the UK, and Japan, will be driven primarily by the launch from 2017 of the first biologic for the treatment of moderate to severe disease, namely Sanofi/Regeneron's dupilumab. Other key growth drivers in the atopic dermatitis space will be the continued uptake of topical calcineurin inhibitors, and the increased use of systemic therapies. The off-label use of Novartis' Xolair is also expected to increase, albeit at a slower rate towards the end of the forecast period. However, Dr Abhilok Garg, GlobalData's Analyst covering Immunology, says dupilumab's launch across the 7MM will be the most pertinent event that could alter the competitive landscape over the mid-to-late forecast period, as the drug is expected to contribute an estimated $3.8 billion to global sales by 2024. Dr Garg explains: "The excitement surrounding dupilumab stems from its novelty as an anti-IL-4R inhibitor, and its promising clinical trial data to date. It also has the potential to displace cyclosporine, which is the current gold-standard systemic agent, but has undesirable side effects that limit its long-term use. "Recent Phase IIb data proving dupilumab to be both safe and efficacious suggests it could be used in younger patients with milder forms of the disease, although its high price may hinder uptake in the early stages of its launch." The analyst adds that although Sanofi/Regeneron's dupilumab is forecast to gain a foothold in the severe population by late-forecast, it will not completely eradicate the high unmet need within the refractory group in this patient segment. Dr Garg continues: "Despite dupilumab's likely impact on the atopic dermatitis treatment space over the next decade, a gap will remain for other novel systemics, as leading dermatologists have emphasized a desire for additional treatment options, preferably orally delivered, to be added to their currently minimal armamentarium." ]]> <![CDATA[Merck, Pfizer get 'breakthrough' status for cancer drug ]]> https://biospectrumindia.com/news/95/7489/merck-pfizer-get-breakthrough-status-for-cancer-drug-.html https://biospectrumindia.com/news/95/7489/merck-pfizer-get-breakthrough-status-for-cancer-drug-.html Fri, 20 Nov 2015 11:43:34 +0530 Merck and Pfizer has announced that the US Food and Drug Administration (US FDA) has granted avelumab, an investigational fully human anti-PD-L1 IgG1 monoclonal antibody, Breakthrough Therapy designation for the treatment of patients with metastatic Merkel cell carcinoma (MCC) who have progressed after at least one previous chemotherapy regimen. Breakthrough Therapy designation is designed to accelerate the development and review of medicines that are intended to treat a serious condition, and preliminary clinical evidence indicates that the therapy may demonstrate a substantial improvement over current available therapies. MCC is a rare and aggressive type of skin cancer. Each year, there are approximately 1,500 new cases of MCC diagnosed in the US. There is currently no therapy approved specifically for the treatment of metastatic MCC. The Breakthrough Therapy designation is based on the preliminary evaluation of clinical data from the global Phase II study, JAVELIN Merkel 200, which is assessing the safety and efficacy of avelumab in patients with metastatic MCC whose disease has progressed after at least one prior chemotherapy regimen. Results from this Phase II study are planned for presentation at upcoming scientific congresses in 2016. The designation represents a significant milestone and has the potential to speed the development of avelumab for metastatic MCC patients. JAVELIN Merkel 200 is a multicenter, single-arm, open-label Phase II study with a primary objective of overall response rate. Secondary endpoints include duration of response, progression-free survival, overall survival and safety. The study, which enrolled 88 patients, is being conducted in sites across Asia Pacific, Australia, Europe and North America. "Metastatic Merkel cell carcinoma is a devastating disease with limited treatment options currently available for patients," said Dr Luciano Rossetti, global head of R&D of the biopharma business of Merck. "With this Breakthrough Therapy designation, we are one step closer to our goal of making a significant difference to patients living with difficult-to-treat cancers, such as metastatic Merkel cell carcinoma, by researching and developing potential new treatment options." "In less than two months, the alliance between Merck and Pfizer has achieved its third regulatory milestone for avelumab, including Orphan Drug designation and Fast Track designation granted in September and October," said Dr Mace Rothenberg, senior vice president of clinical development and medical affairs and chief medical officer for Pfizer Oncology. "We are very pleased with the progress of the JAVELIN clinical development program and we are looking forward to presenting additional data on the potential of this investigational compound in Merkel cell carcinoma and other tumor types in 2016." The clinical development program for avelumab now includes more than 1,400 patients who have been treated across more than 15 tumor types, including breast cancer, gastric/gastro-esophageal junction cancers, head and neck cancer, MCC, mesothelioma, melanoma, non-small cell lung cancer, ovarian cancer, renal cell carcinoma and urothelial (e.g., bladder) cancer. ]]> <![CDATA[Will Indian pharma embrace batch to continuous processing?]]> https://biospectrumindia.com/news/95/6810/will-indian-pharma-embrace-batch-to-continuous-processing.html https://biospectrumindia.com/news/95/6810/will-indian-pharma-embrace-batch-to-continuous-processing.html Fri, 20 Nov 2015 11:43:00 +0530 STEERLife, incubated since 2013 and rolled- out as an entity in April 2014, is run by MD & chief knowledge officer, Dr Babu Padmanabhan, and chairman Dr Himadri Sen (former research head at Ranbaxy), and has an ambitious goal of reaching the Unicorn status by 2020. The start-up aims to revolutionize the pharmaceutical industry by changing the way medicines are 'made' and 'taken', i.e., to transition from the conventional batch process manufacturing practice to continuous processing (B2C); and from swallowing-to-sipping medicines. The traditional batch processing involves multiple steps including blending, wet granulation, drying, milling, compression and coating. After each of these steps, the product (semi-batch) is collected, quality checked, and then is put through the next process of operation before ending up as a finished product, thereby making the whole process very cumbersome, inefficient, and time-consuming causing environmental hazards. Currently, the pharmaceutical industry employees batch processing method, which is as old as Industrial Revolution, leading to producing products of inconsistent quality, paving way for pharma facilities and manufacturing plants being written-off or shutdown owing to defects, contaminations, or improper testing. "The manufacturing process adopted by the pharma industry is similar to that of mixing cement and sand to make concrete blocks. In batch processing, it takes several hours with repeated handling and testing of the batch. However, with continuous process, it reduces to anywhere between 3 to 30 seconds. It is a greener technology," said Dr Padmanabhan, while talking to the media at a press conference in Bangalore on November 19, 2015. Dr Janet Woodcock, director, Center for Drug Evaluation and Research (CDER), United States Food and Drug Administration (USFDA), commented at an American Association of Pharmaceutical Scientists (AAPS) annual meeting in 2011, "Right now, manufacturing experts from the 1950s would easily recognize the pharmaceutical manufacturing processes of today. It is predicted that manufacturing will change in the next 25 years as current manufacturing practices are abandoned in favor of cleaner, flexible, more efficient continuous manufacturing." Right now there are no specific regulations and guidelines for continuous manufacturing or for prohibiting it. Dr Sen said that the USFDA will force the pharma industry to adopt the continuous manufacturing process. "The USFDA will be a facilitator and will request the industry to change from quality-by-testing (QbT) to quality-by-design (QbD)," he added. Advantages of continuous processing include better quality, energy efficiency, lesser waste management and more greener towards the environment. STEERLife's technologies include Hot Melt Extrusion (HME), Hot Melt Fragmentation (HMF - patent pending), and Activated Granulation. The company's another patent-pending Effervescence Technology (EVT) looks to transform the traditional swallowing of pills to sipping it. Pharma companies can now extend their patents for 3 additional years through introducing the same USFDA-approved drug in a different dosage format, i.e., as effervescent tablets, which is sipped after dissolving in water. Introduction of drugs in a different dosage form is considered as 'dosage innovation'. Generally, the USFDA expects pharma companies to introduce their same approved drugs for Geriatric (older adults) and Pediatric (children) patients in easily ingestible dosage forms. However, companies abandon that option owing to higher cost of production. Dr Sen revealed that the company first intends to introduce its processing technology to MNCs in the US than to Indian companies. The company's development center in India is located in Bangalore due to high costs involved in the US. In India, the R&D costs is about one-fifth to that of the US. The technology has been developed at its Bangalore development center. An investment of Rs 7-10 crore (US $1.5-2.0 million) has gone into STEERLife through internal approvals within the company. STEERLife so far has been in talks with 4 Indian MNCs and 1 foreign MNC for implementing its technology. The company also targets other industries including nutraceuticals and beverages for implementing its processing technology. It has filed 3 patents which are at various stages in the application process. It usually takes 1.5-2 years for granting a patent. Mr Dipak Chattaraj, ex-chairman of Ranbaxy USA, serves as STEERLife's advisor, and Mr Indu Bhushan as chief technology officer (CTO). Established in 1993, STEER Group creates advanced materials platform technologies for the plastics, pharma, food & nutraceuticals, biomaterials and biorefining industries. It has 5 global offices, 10 satellite offices and 3 application development centers, and employs over 500 professionals. ]]> <![CDATA[Merck completes Sigma-Aldrich acquisition]]> https://biospectrumindia.com/news/95/7586/merck-completes-sigma-aldrich-acquisition.html https://biospectrumindia.com/news/95/7586/merck-completes-sigma-aldrich-acquisition.html Fri, 20 Nov 2015 11:40:13 +0530 Merck has announced the completion of its $17 billion acquisition of Sigma-Aldrich, creating one of the leaders in the $130 billion global industry to help solve the toughest problems in life science. The completion follows last week's approval from the European Commission, which was the final antitrust condition required to close the Sigma-Aldrich transaction. Following the acquisition, Merck will have around 50,000 employees in 67 countries, working at 72 manufacturing sites worldwide. "The acquisition of Sigma-Aldrich marks the culmination of almost a decade of transformation, further affirming that Merck is a leading science and technology company," said Mr Karl-Ludwig Kley, CEO and chairman of Merck. "We're now a leading player in the $130 billion global life science industry and together with our two other growth platforms Healthcare and Performance Materials, Merck is set to tackle global challenges that will fundamentally change the world in which we live." With the acquisition of Sigma-Aldrich, Merck will be able to serve lifescience customers around the world with a highly attractive set of established brands such as SAFC and BioReliance, in addition to Millipore and Milli-Q, as well as an efficient supply chain that can support the delivery of more than 300,000 products. The company will cover every step of the biotech production chain, creating a complete end-to-end workflow with enhanced customer service, a simplified customer interface and a leading distribution platform. To ensure a smooth integration, Merck has made significant progress on integration planning for the new business, which will be named Merck all across the world, except for the US and Canada, where the business will be named MilliporeSigma. The future organization will tap into the industry-leading talent of both legacy organizations, with a focus on promoting customer centricity, continuous innovation and strengthened capabilities. "With the acquisition complete, we can now start tackling the challenge of solving the toughest problems in life science by collaborating with the global scientific community and helping to increase access to healthcare. We are excited to begin leveraging the proven operational excellence of our organizations to provide a growing customer base with more efficient and innovative solutions," said Mr Udit Batra, president and CEO of the life science business of Merck. "We've designed the new organization to fully tap into our combined capabilities, particularly in integrated supply chain operations, information technology and e-commerce." Sigma-Aldrich's SAFC Commercial business, excluding the SAFC Hitech business, will be part of Merck's Life Science business sector. The SAFC Hitech business will be integrated into Merck's Performance Materials business and will operate as part of its Integrated Circuits business unit. SAFC Hitech and Merck's Performance Materials businesses offer complementary technologies, making these two businesses a natural fit. ]]> <![CDATA[Govt to set up biomedical institute at Hyderabad]]> https://biospectrumindia.com/news/95/7680/govt-to-set-up-biomedical-institute-at-hyderabad.html https://biospectrumindia.com/news/95/7680/govt-to-set-up-biomedical-institute-at-hyderabad.html Thu, 19 Nov 2015 11:40:57 +0530 Chaired by the Prime Minister, Mr Narendra Modi, union cabinet on November 18, 2015, has approved the proposal of the Department of Health Research in the Ministry of Health and Family Welfare for setting up of a National Resource Facility for Bio-medical Research (NARF) at Genome Valley in Hyderabad by the Indian Council for Medical Research (ICMR). The estimated project cost is Rs 338.58 crore and the resource center is expected to be functional by 2018-19. The institution will be the first of its kind for quality laboratory animals for basic and applied biomedical research in the country. It will be developed as a world-class facility for breeding and housing of animals such as primates, cabines and other specialized models such as transgenic and knockout rodents required for testing of various R&D products. The facility will create, develop and provide access to a range of laboratory animals and related technological resources for advancement of biomedical research in the country, mainly to facilitate research in medical colleges, research and academic institutions, universities and Biotech/Bio-pharma companies. The facility will also provide training facilities for personnel in the specialized areas in the field of biomedical research. The State Government has allotted 102.69 acres of land at Genome Valley, Hyderabad, free of cost, to the ICMR for Establishment of National Animal Resource Facility (NARF) for Biomedical Research. ]]> <![CDATA[Dr Reddy's buys IP rights for Fondaparinux]]> https://biospectrumindia.com/news/95/6207/dr-reddys-buys-ip-rights-for-fondaparinux.html https://biospectrumindia.com/news/95/6207/dr-reddys-buys-ip-rights-for-fondaparinux.html Thu, 19 Nov 2015 11:11:13 +0530 Dr Reddy's Laboratories has announced that it has completed the purchase of worldwide exclusive intellectual property rights for Fondaparinux sodium, its generic anti-coagulant drug from its Australian partner, Alchemia. Earlier, the company had signed a term sheet for this transaction in September, 2015. Alchemia's shareholders approved the sale of Fondaparinux at the Company's annual general meeting held on 10 November 2015, post which Dr Reddy's and Alchemia have executed a purchase and sale agreement, together with various patent assignment deeds. Alchemia has received $17.5 million from Dr Reddy's as consideration for the sale. Alchemia is a drug discovery and development company marketing Fondaparinux in the US and other markets, via partner Dr Reddy's. The agreement is effective July, 2015. ]]> <![CDATA[Piramal Healthcare invests Â£2 million in Scotland ]]> https://biospectrumindia.com/news/95/5639/piramal-healthcare-invests-2-million-in-scotland-.html https://biospectrumindia.com/news/95/5639/piramal-healthcare-invests-2-million-in-scotland-.html Wed, 18 Nov 2015 11:55:10 +0530 Piramal Healthcare UK has invested £2 million (approx. Rs 201.050 million) into Scotland to expand its manufacturing base at Grangemouth, to manufacture Antibody Drug Conjugates to global markets. This new investment into Scotland will yield additional revenue of £3-5 million over 5 years to Piramal Healthcare's revenues. The announcement was made by the First Minister at Piramal's new facility, where up to 20 new high-skill job roles will be created, backed by £200,000 Regional Selective Assistance funding. Piramal Healthcare is a key element to the antibody drug conjugate (ADC) hub in Scotland and this further expansion is testament to Scotland's attractiveness as a life sciences manufacturing location. Expert manufacture such as that delivered by Piramal is only one of the many interconnected segments of Scotland's globally competitive Pharma services sector with over 160 companies, rigorous quality controlled environment, supportive clinical trial environment and high quality innovative manufacture. First Minister Ms Nicola Sturgeon said, "Piramal is a great example of an innovative company that is benefitting from the focus Scotland places on the life sciences sector, which employs around 33,000 people across the country. We have a thriving research and innovation led Life Sciences sector and Piramal is seeing the benefit of that as they manufacture products that are involved in the treatment of various types of cancer. I am delighted to be opening this new manufacturing suite and welcome Piramal's continued commitment to Scotland." Piramal Healthcare site lead , Mr Mark Wright, said, "Piramal Healthcare UK Ltd has been growing its operations in Grangemouth since 2005 and currently employs around 140 people in predominantly highly skilled positions. We aim to scale up this facility in the next 5 years to maintain its position as a global leader in the production of Antibody Drug Conjugates." Country Director, Scottish Development International, India, Ms Rooma Kumar Bussi said, "Scottish Development International has worked with Piramal Healthcare for a number of years to support their Scottish operations. I am truly delighted to see continued growth at Piramal's Grangemouth facility in Scotland, which in turn supports their global markets. Scotland continues to maintain its position as the top UK region to attract FDI outside of London and this bears testimony to its world class talent and innovation landscape. Scotland has a thriving life sciences community and a close-knit business and academic ecosystem which presents tremendous supply chain opportunities to the pharma industry. Piramal's presence in Scotland has played an integral role in cementing Scotland's position as a location of choice for FDI and I look forward to working with the company as they expand their operations in Scotland." ]]> <![CDATA[Philips launches prototype of children's automated respiration monitor]]> https://biospectrumindia.com/interviews/95/6176/philips-launches-prototype-of-childrens-automated-respiration-monitor.html https://biospectrumindia.com/interviews/95/6176/philips-launches-prototype-of-childrens-automated-respiration-monitor.html Wed, 18 Nov 2015 11:53:21 +0530 Philips on November 17, 2015 announced a Children's Automated Respiration Monitor prototype that is aimed to help improve the diagnosis and treatment of pneumonia in India, potentially preventing many of the 935,000 childhood deaths caused by pneumonia each year. The respiration monitor will undergo further research and validation as part of the ongoing project. Accounting for over 15 percent of child mortality worldwide, India loses a child every minute to pneumonia. Rajasthan, Uttar Pradesh, Madhya Pradesh, Assam and Bihar are some of the main pneumonia prone states in the country. Each year, the infection kills more children than AIDS, malaria and tuberculosis combined and remains the leading infectious cause of death among children under five years of age. Global child health organizations like UNICEF have made pneumonia a key area of focus in its effort to reduce child mortality in underdeveloped countries throughout the world. One important aspect in diagnosing pneumonia is monitoring a child's breathing rate. In developing countries, community health workers manually count how many breaths a child takes in the span of one minute. The Philips Children's Automated Respiration Monitor converts chest movements detected by accelerometers into accurate breathing counts, using algorithms aligned with World Health Organization (WHO) guidelines to diagnose fast breathing rates, tailored to the way children's chests move during breathing. Accurate diagnosis would ensure that children with pneumonia receive the antibiotics they need, potentially preventing many of the deaths caused by pneumonia each year. Mr Srinivas Prasad, CEO, Philips Innovation Campus says, "One of our focus areas has been to make a difference in the markets that have persistent healthcare challenges and help them overcome barriers to treatment and care. Philips Children's Automated Respiration Monitor being one such innovation is clearly driven to reduce child mortality and is a solution well suited for underdeveloped and developing nations. This innovation can become a game changer in diagnosing and treating pneumonia and will be affordable for healthcare and community workers globally." The respiration monitor is a "Make in India" product and will be manufactured at the Philips factory in Pune for the Indian and global markets. The product being the first of its kind, Philips is working both with local end users, as well as key stakeholders in the global health community to ensure that the monitor design and functionality will meet their needs on the ground. Philips is currently working with various leading global child health organizations to conduct field trials with the next generation of prototypes in key markets where child mortality due to pneumonia is high. ]]> <![CDATA[Shire's Lifitegrast to boost dry eye syndrome treatment market to $4.6 bn by 2024]]> https://biospectrumindia.com/features/95/7930/shires-lifitegrast-to-boost-dry-eye-syndrome-treatment-market-to-4-6-bn-by-2024.html https://biospectrumindia.com/features/95/7930/shires-lifitegrast-to-boost-dry-eye-syndrome-treatment-market-to-4-6-bn-by-2024.html Tue, 17 Nov 2015 12:22:59 +0530 The global treatment market for dry eye syndrome will more than double in value from approximately $2.2 billion in 2014, to reach an estimated $4.6 billion by 2024, representing a Compound Annual Growth Rate (CAGR) of 7.9%, according to research and consulting firm GlobalData. The company's latest report states that this rise, which will occur across the Nine Major Markets (9MM) of the US, France, Germany, Italy, Spain, the UK, Japan, China, and India, will be driven primarily by the introduction of novel drugs, most notably Shire's lifitegrast, a first-in-class drug with anti-inflammatory benefits. Furthermore, Dr Catherine Daly, GlobalData's Senior Analyst covering Neurology and Ophthalmology, says the paucity of dry eye syndrome treatments in the US and European markets will allow Shire to secure strong uptake and a sizable market share for lifitegrast. Dr Daly comments: "GlobalData expects that lifitegrast, which is anticipated to launch in the US in late 2016, will eventually reach peak sales of $1 billion across the 9MM, earning the drug blockbuster status. "Furthermore, Allergan's blockbuster dry eye syndrome drug, Restasis, which generated an estimated $1.33 billion in US sales in 2014, is expected to launch in the European markets during the forecast period and will secure a sizable patient share." The analyst adds that Mimetogen's MIM-D3, Mitotech's Visomitin, and RegeneRx's RGN-259 are also expected to see strong sales growth by 2024, as these first-in-class drugs all have different therapeutic benefits to offer dry eye syndrome patients. Despite this, considerable opportunities remain within the dry eye syndrome arena, as there are currently very few approved treatment options. Dr Daly continues: "Better understanding of the etiology and pathogenesis of dry eye syndrome is revealing new therapeutic targets, and therefore is increasing the opportunities to develop novel therapeutics that can offer clinical benefits for certain patients. "There is also a need to simplify dosing for patients who have the daily burden of self-administering multiple eye drops, which could be met with the development of long-acting drugs." ]]> <![CDATA[Dr Shiva starts online petition against GM Mustard]]> https://biospectrumindia.com/news/95/8320/dr-shiva-starts-online-petition-against-gm-mustard.html https://biospectrumindia.com/news/95/8320/dr-shiva-starts-online-petition-against-gm-mustard.html Tue, 17 Nov 2015 12:05:00 +0530 In an anticipatory reaction to the approval of GM Mustard by the environment ministry, Dr Vandana Shiva, a known fierce critic of GM crops has started a online petition against it. Her petition on Change.Org, the online platform to draw attention of government mentions, "This 'new' mustard in our kitchen could soon be harmful to us. Mustard oil is an everyday consumption item for lakhs of families across India. Almost all our curries are incomplete without a seasoning of mustard and mustard products find their way into our food in various ways. Don't we have babies massaged with mustard oil? Have we not enjoyed Sarson da Saag on cold winter days?" Going into details, the petition says, "And now our mustard is getting Genetically Modified. Shockingly, important information about this new GM mustard is not being disclosed to us. The government regulators are planning to meet soon and take a decision on permitting GM mustard to be cultivated across the country. If approved, GM mustard will be the first GM food on our plates and that's disturbing." The petition argues that the GM Mustard is totally unnecessary especially because there are existing local and hybrid varieties as well as farm practices which give as much or more than the yield claims of this dangerous GM mustard. Dr Shiva exhorted people to ask environment minister, Mr Prakash Javadekar to stop the possible approval of commercial cultivation of GM Mustard. "Several studies show that GM food is not safe for us. Indian government is aware of such studies. Many people have pointed to the dangers of GM food including experts and even the Technical expert committee set up by the Supreme Court itself. Despite these warnings, GM Mustard is now going to be released in India. However no data has been released about its safety tests. Nor has information been put out on what went into making this GM mustard. This includes the fact that new genes for male sterility and tolerance towards weed-killing chemicals called herbicides have been used to make this GM mustard. The herbicides in question are associated with big MNCs like Bayer," stated the petition. Dr Shiva through her petition asked environment minister, Mr Prakash Javadekar to ensure no commercial cultivation of GM Mustard is permitted and release all data about the GM Mustard safety tests. When asked about the petition, an industry expert termed it a useless activity. "Even before the approval, a mass hysteria is being tried to be whipped up. Though everybody has a right to their opinion but it should not be based on their personal grudges and prejudices. GM Mustard has been tested for a long time and government will go by the data produced by scientists," he stated. ]]> <![CDATA[Widespread public misunderstanding about antibiotic resistance: WHO]]> https://biospectrumindia.com/news/95/8449/widespread-public-misunderstanding-about-antibiotic-resistance-who.html https://biospectrumindia.com/news/95/8449/widespread-public-misunderstanding-about-antibiotic-resistance-who.html Tue, 17 Nov 2015 11:57:07 +0530 Antibiotic resistance happens when bacteria change and become resistant to the antibiotics used to treat the infections they cause. Over-use and misuse of antibiotics increase the development of resistant bacteria, and this survey points out some of the practices, gaps in understanding and misconceptions which contribute to this phenomenon. Almost two thirds (64 percent) of some 10 000 people who were surveyed across 12 countries say they know antibiotic resistance is an issue that could affect them and their families, but how it affects them and what they can do to address it are not well understood. For example, 64 percent of respondents believe antibiotics can be used to treat colds and flu, despite the fact that antibiotics have no impact on viruses. Close to one third (32 percent) of people surveyed believe they should stop taking antibiotics when they feel better, rather than completing the prescribed course of treatment. "The rise of antibiotic resistance is a global health crisis, and governments now recognize it as one of the greatest challenges for public health today. It is reaching dangerously high levels in all parts of the world," says Dr Margaret Chan, WHO director-general, in launching the survey findings today. "Antibiotic resistance is compromising our ability to treat infectious diseases and undermining many advances in medicine." The survey findings coincide with the launch of a new WHO campaign 'Antibiotics: Handle with care'-a global initiative to improve understanding of the problem and change the way antibiotics are used. The conclusions from India were drawn on the basis of 1,023 online interviews: â€¢ More than three quarters (76 percent) of respondents report having taken antibiotics within the past six months; 90 percent say they were prescribed or provided by a doctor or nurse. â€¢ Three quarters (75 percent) of respondents think, incorrectly, that colds and flu can be treated with antibiotics; and only 58 percent know that they should stop taking antibiotics only when they finish the course as directed.â€¢ While 75 percent agree that antibiotic resistance is one of the biggest problems in the world, 72 percent of respondents believe experts will solve the problem before it becomes too serious. "The findings of this survey point to the urgent need to improve understanding around antibiotic resistance," says Dr Keiji Fukuda, special representative of the director-general for antimicrobial resistance. "This campaign is just one of the ways we are working with governments, health authorities and other partners to reduce antibiotic resistance. One of the biggest health challenges of the 21st century will require global behaviour change by individuals and societies." The multi-country survey included 14 questions on the use of antibiotics, knowledge of antibiotics and of antibiotic resistance, and used a mix of online and face-to-face interviews. It was conducted in 12 countries: Barbados, China, Egypt, India, Indonesia, Mexico, Nigeria, the Russian Federation, Serbia, South Africa, Sudan and Viet Nam. While not claiming to be exhaustive, this and other surveys will help WHO and partners to determine the key gaps in public understanding of this problem and misconceptions about how to use antibiotics to be addressed through the campaign. Some common misconceptions revealed by the survey include: â€¢ Three quarters (76 percent) of respondents think that antibiotic resistance happens when the body becomes resistant to antibiotics. In fact bacteria-not humans or animals-become resistant to antibiotics and their spread causes hard-to-treat infections.â€¢ Two thirds (66 percent) of respondents believe that individuals are not at risk of a drug-resistant infection if they personally take their antibiotics as prescribed. Nearly half (44 percent) of people surveyed think antibiotic resistance is only a problem for people who take antibiotics regularly. In fact, anyone, of any age, in any country can get an antibiotic-resistant infection. â€¢ More than half (57 percent) of respondents feel there is not much they can do to stop antibiotic resistance, while nearly two thirds (64 percent) believe medical experts will solve the problem before it becomes too serious. Another key finding of the survey was that almost three quarters (73 percent) of respondents say farmers should give fewer antibiotics to food-producing animals. To address this growing problem, a global action plan to tackle antimicrobial resistance was endorsed at the World Health Assembly in May 2015. One of the plan's five objectives is to improve awareness and understanding of antibiotic resistance through effective communication, education and training. ]]> <![CDATA[Ajanta Pharma launches asthma drug in the US ]]> https://biospectrumindia.com/news/95/3184/ajanta-pharma-launches-asthma-drug-in-the-us-.html https://biospectrumindia.com/news/95/3184/ajanta-pharma-launches-asthma-drug-in-the-us-.html Tue, 17 Nov 2015 11:54:36 +0530 Ajanta Pharma USA, a subsidiary of Ajanta Pharma has announced the launch of Montelukast Sodium Oral Granules (4mg), a bioequivalent generic version of SINGULAIR Granules, in the US market. Ajanta Pharma offers Montelukast Granules in cartons containing 30 individual sachets. The approval and launch of the Montelukast Granules is part of an ever-growing portfolio that Ajanta Pharma has developed for the US market. To date, the United States Food and Drug Administration (US FDA) has granted Ajanta Pharma five ANDA final approvals and two ANDA tentative approvals. An additional 19 ANDAs are pending approval from the US FDA. SINGULAIR is a registered trademark of Merck and Co., Inc. ]]> <![CDATA[ICGEB scientist wins Infosys Prize 2015 ]]> https://biospectrumindia.com/news/95/8107/icgeb-scientist-wins-infosys-prize-2015-.html https://biospectrumindia.com/news/95/8107/icgeb-scientist-wins-infosys-prize-2015-.html Mon, 16 Nov 2015 18:18:01 +0530 In its 7th year now, the coveted prize this year in Life Sciences was awarded to Dr Amit Sharma (47), group leader, structural and computational biology group, International Centre for Genetic Engineering and Biotechnology (ICGEB), New Delhi, for his outstanding contributions in deciphering the molecular structure, at the atomic level, of key proteins involved in the biology of pathogenesis of malarial parasite. Dr Sharma has a PhD from Northwestern University, USA, in Protein Crystallography (1995). He then pursued his post-doctoral work at the Oxford University, UK, between 1996-2000, in the area of structural biology. His work on the deadly malarial parasite has the potential value for vaccine design, and development of therapeutics for malaria. The prize consists of cash worth Rs 65 lakh, a 22 karat gold medallion, and a citation certificate. Previously, winners were given a cash prize of Rs 55 lakh. Mr Shibulal, president, board of trustees, Infosys Science Foundation, attributed this increase to the current currency exchange rates, while addressing the media on the morning of November 16, 2015, during the official awards announcement at the Infosys Campus, Bangalore. The Infosys Science Foundation, a not-for-profit trust created in 2009, has been awarding top minds in research and science across 6 categories to foster a culture of scientific thinking and 'restore the romance of research'. The categories include Engineering and Computer Science, Humanities, Life Sciences, Mathematical Sciences, Physical Sciences and Social Sciences. The Foundation is funded by a corpus which stands at Rs 130 crore (US $20 million), contributed by Infosys' former board directors and senior management. In 2014, under the Life Sciences category, Prof Shubha Tole, an associate professor and principal investigator, department of biological sciences, Tata Institute of Fundamental Research (TIFR), Mumbai, won the award. For 2013, Dr Rajesh Gokhale, director, CSIR-Institute of Genomics and Integrative Biology (CSIR-IGIB), New Delhi, bagged the prize for the same category. The awarding ceremony will be held on February 13, 2016, in New Delhi, with the winners being felicitated by Hon. Indian President Shri Pranab Mukherjee. For 2015, the organization received as many as 206 nominations in all the 6 categories, compared to 136 in 2009. Here is the break-up of nominations: ï‚§ Engineering and Computer Science: 44ï‚§ Humanities: 32ï‚§ Life Sciences: 40ï‚§ Mathematical Sciences: 27ï‚§ Physical Sciences: 40ï‚§ Social Sciences: 23 He pointed that the number of nominations have gone up in the last 7 years. "The winners' work will take time for the impact to materialize. These are fundamental research which will get applied over a period of time," he added. Once a person is nominated, the nomination is valid for 3 years, said Mr Shibulal. "Nominees' merit, their work in India, and an age limit of 50 years, in exceptional situations up to 55, are the basic criteria, and the final decision is taken by the jury," he said. Nominees are always nominated by peers and has the chance to get nominated again by another peer. However, self-nominations are not considered by the jury. When asked about the impact of research works of previous years' winners, Mr Narayan Murthy said, "It is not fair to judge people in such shorter periods of time. In the long-term, we will see their works having tremendous impact on the whole world." He continued, "We have no doubt at all that advancements in scientific research will indeed make India and the world a better place. It makes more sense why we should focus on science, engineering & technology and social sciences, because that's the only way we can create a better world. We have to keep recognizing more and more people who have done excellent work in scientific research... The difference between the rich and poor is coming down. Access to education, healthcare and nutrition has become easier for the poorer masses through advances in science and technology." The winners of the other 5 categories are: ï‚§ Engineering and Computer Science Prof Umesh Waghmare, Professor - Theoretical Sciences Unit, Jawaharlal Nehru Centre for Advanced Scientific Research (JNCASR), Bangalore, India, is awarded for his innovative use of first-principles theories and modeling in insightful investigations of microscopic mechanisms responsible for specific properties of certain materials such as topological insulators, ferro-electrics, multi-ferroics and graphene. ï‚§ Humanities Prof Jonardon Ganeri, Global Network Visiting Professor of Philosophy, New York University and Recurrent Visiting Professor, Department of Philosophy, King's College London, UK, is awarded for his outstanding scholarship and originality in interpreting and scrutinizing analytical Indian Philosophy and shedding light on shared ground as well as the dichotomy between Indian and Greek traditions of philosophical reasoning. ï‚§ Mathematical Sciences Prof Mahan Maharaj, Associate Professor of Mathematics, Ramakrishna Mission Vivekananda University, Belur Math, Howrah, India, is awarded for his contributions to geometric group theory, low-dimensional topology and complex geometry. In particular, he established a central conjecture in the Thurston program to study hyperbolic 3-manifolds and introduced important new tools to study fundamental groups of complex manifolds. ï‚§ Physical Sciences Prof G Ravindra Kumar, Professor, Department of Nuclear and Atomic Physics (DNAP), Tata Institute of Fundamental Research (TIFR), Mumbai, India, is awarded for his pioneering experimental contributions to the physics of high intensity laser matter interactions. In particular for providing, for the first time, unequivocal evidence of turbulent magnetic fields and the discovery of terahertz frequency acoustic waves, in laser produced hot dense plasmas. These results have significance to testing stellar and astrophysical scenarios. ï‚§ Social Sciences Dr Srinath Raghavan, an ex-military officer, and Senior Fellow, Centre for Policy Research, New Delhi, India, is awarded for outstanding research that synthesizes military history, international politics, and strategic analysis into powerful and imaginative perspectives on India in global context. The winners of the Infosys Prize 2015 were evaluated by a panel of jurors including Prof Pradeep K Khosla (University of California, San Diego, USA) for Engineering and Computer Science; Prof Amartya Sen (Harvard University, USA) for Humanities; Dr Inder Verma (Salk Institute of Biological Sciences, USA) for Life Sciences; Prof Srinivasa S R Varadhan (New York University, USA) for Mathematical Sciences; Prof Shrinivas Kulkarni (California Institute of Technology, USA) for Physical Sciences; and Prof Kaushik Basu (The World Bank, USA) for Social Sciences. ]]> <![CDATA[GIGH & AIIMS join hands to prevent type 2 diabetes]]> https://biospectrumindia.com/news/95/2999/gigh-aiims-join-hands-to-prevent-type-2-diabetes.html https://biospectrumindia.com/news/95/2999/gigh-aiims-join-hands-to-prevent-type-2-diabetes.html Mon, 16 Nov 2015 11:18:19 +0530 The George Institute for Global Health has teamed up with the All India Institute of Medical sciences (AIIMS) to conduct research that will explore whether a lifestyle modification program can delay the onset of type 2 diabetes in women with gestational diabetes mellitus (GDM) in South Asia. The research involves conducting a randomized trial of a lifestyle modification program to determine whether it can be applied and affordably brought to scale in Bangladesh, Sri Lanka and India. "The development of diabetes in women with GDM can be prevented or delayed. It has been shown in research settings that healthy diet and physical activity aimed at weight reduction can delay or prevent the development of diabetes in women with GDM, but we do not know how to best achieve such behavioral changes" says Professor Nikhil Tandon, head, Department of Endocrinology at AllMS. "If the intervention is found to be effective and scalable, the development of Type 2 Diabetes could be delayed or prevented in more than a quarter of a million young South Asian women over a 5-year period," said Professor Anuskha Patel, chief scientist, The George Institute for Global Health and Professor of Medicine at the University of Sydney. Type 2 diabetes is the world's fastest growing chronic disease. Over 347 million people have diabetes with more than 80 percent of these living in low-middle income countries. GDM is diabetes developing for the first time in pregnancy. In pregnancy, the placenta makes hormones that helps the baby to grow and develop. Gestational diabetes occurs because these hormones also block the action of the mother's insulin. The hormones of pregnancy cause resistance to the actions of insulin and lead to higher blood sugar levels in women who have risk factors for diabetes. Previously thought to be a relatively benign condition, it is now known that having GDM puts women at high risk of subsequently developing Type 2 diabetes - a condition that needs lifelong treatment and is associated with a number of serious complications. The feasibility study conducted in India in 2011 and led by Professor Tandon was supported by a BRIDGES Grant from the International Diabetes Federation. This study, along with behavioral interventions shown to prevent weight gain in pregnant women and young mothers in Australia, have laid the foundation of the intervention that will be developed and evaluated in 1400 women from India, Bangladesh and Sri Lanka. Collaborating partners include Monash University in Australia, The University of Kelaniya in Sri Lanka, icddr,b in Bangladesh, and the Centre for Chronic Disease Control, India. Under the auspices of the Global Alliance for Chronic Diseases (GACD), the Indian arm of the research is being supported by the Indian Council of Medical Research (ICMR), while the Australian National Health and Medical Research Council is funding the research in Sri Lanka and Bangladesh. According to Professors Tandon and Patel, the GACD grants will make an enormous difference in treating, preventing and managing Type 2 Diabetes, especially in areas with limited resources and poor access to essential healthcare. ]]> <![CDATA[WHO calls for an end to diabetes]]> https://biospectrumindia.com/news/95/4638/who-calls-for-an-end-to-diabetes.html https://biospectrumindia.com/news/95/4638/who-calls-for-an-end-to-diabetes.html Mon, 16 Nov 2015 11:13:10 +0530 The Regional Director for South-East Asia, Dr Poonam Khetrapal in her message on November 14, 2015 talked about the importance of eliminating diabetes. She mentioned, "Diabetes is a global epidemic which kills one person every six seconds and over 5 million every year. Diabetes makes people prone to heart disease, kidney failure and infectious diseases such as tuberculosis, malaria, and HIV/AIDS, among others, leading to premature deaths. The diabetes epidemic is growing in many countries. The number of people with diabetes is projected to increase alarmingly from 457 million in 2014 to 592 million by 2035, if we do not act now to arrest this trend." Diabetes can be prevented and treated. World Diabetes Day, created in 1991 by the International Diabetes Federation and WHO is focusing on "Healthy Living and Diabetes" as the theme for 2014 to 2016, and the importance of prevention in diabetes. To put the spotlight on the urgent need to act against diabetes, World Health Organization has selected diabetes, as the theme for the World Health Day 2016. WHO South-East Asia Region is home to an estimated 91 million people affected by diabetes. Approximately half of them go undiagnosed. WHO is supporting countries by advocating for and catalyzing multisectoral policies for health promotion and strengthening national health systems for early detection and treatment of diabetes. These include training health workforce, developing treatment norms and increasing the availability of basic diagnostics and essential medicines at primary health care centers. "We need to work collaboratively with governments, civil society, private sectors, schools, workplaces, media and other local partners. We all have a role to play to ensure healthier environment for a healthy living. However, the key role is of an individual to make lifelong healthy choices for a healthier future," said Dr Khetrapal. Taking small steps like eating right, regular physical activity and maintaining a healthy weight can cut the risk of diabetes or delay its onset ]]> <![CDATA[World Diabetes Day: Clinical trials for new diabetes drugs urgently needed in India]]> https://biospectrumindia.com/news/95/4513/world-diabetes-day-clinical-trials-for-new-diabetes-drugs-urgently-needed-in-india.html https://biospectrumindia.com/news/95/4513/world-diabetes-day-clinical-trials-for-new-diabetes-drugs-urgently-needed-in-india.html Fri, 13 Nov 2015 14:01:56 +0530 This year the theme is 'Healthy Living and Diabetes'. India has the second highest number of people with diabetes in the world1 with 66.84 million diabetes cases in the country today. An estimated 1 in 12 adults suffer from this lifestyle disease and many cases remain undiagnosed. The ever-increasing diabetes burden has a cascading impact on our nation's health expenditure and healthcare resources. Adopting better diabetes management practices and developing more efficacious treatment for diabetes and its resultant complications are an important need. There is also an urgent need for investments in more clinical research to ensure that patients can benefit from newer and better medicines says the Indian Society for Clinical Research (ISCR), an association of clinical research professionals. Diabetes is a chronic disease which often leads to a number of complications. Currently not all of these can be treated efficiently with the drugs available. So as new promising molecules emerge and global clinical research is done for these, India's participation will mean faster access to new drugs for diabetics in the country. "The last two years has seen a drop in clinical research being done in the country which has meant delayed access to newer therapies and treatment for our population," said Ms Suneela Thatte, President, ISCR. "Given that India has the largest disease burden in the world, we hope that the recently amended clinical research regulatory guidelines will see more organisations investing in doing clinical research in the country. We have a moral responsibility to ensure that patients in our country have access to newer and better medicines. Given the high incidence of diabetes in India, clinical research will also help identify which medicines work best for our genetic disposition which is critical to managing our growing diabetes burden." Dr Manoj Chawla, Consultant Diabetologist and Coordinator, Department of Diabetology, Asian Heart institute & Research Centre, an investigator in a recently concluded diabetes clinical trial said, "Given the growing burden of diabetes in our country, it is extremely important for us to test the efficacy of new medicines on our population which is only possible through clinical research. "It is not just patients but we, as investigators, as well who benefit from clinical research because through participating in research, we learn more about newly developed drugs, their benefits and risks. This enables us to play a strong role as global opinion leaders in the safety and efficacy of new drugs for native populations," he added. A patient in Delhi who participated in a diabetes trial (name withheld to protect patient confidentiality) said, "I was advised to enrol in clinical research by my diabetologist. Being diagnosed with diabetes, I went through a very difficult time and it was tough on my family too. "When I was told about the potential benefits of a new diabetes drug which was not available in the market, I decided to participate in a clinical trial and do not regret it." He further said, "It felt good to be surrounded by people who, just like me are fighting this lifelong disease. The trial helped me understand my condition better and the medication I received helped me manage my diabetes more efficiently." ]]> <![CDATA[Dr Reddy's barred from selling Esomeprazole Capsules in the US]]> https://biospectrumindia.com/news/95/6550/dr-reddys-barred-from-selling-esomeprazole-capsules-in-the-us.html https://biospectrumindia.com/news/95/6550/dr-reddys-barred-from-selling-esomeprazole-capsules-in-the-us.html Fri, 13 Nov 2015 12:37:00 +0530 The District Court of Delaware, USA, has passed an order granting a Temporary Restraining Order (TRO) with immediate effect on sales, delivery, transfer, or other disposition of Dr Reddy's Laboratories' generic esomeprazole product in the US market. The order came about as a result of a motion moved by AstraZeneca objecting to the usage of the colour Purple in the said generic product. The order has been passed pending further hearing or trial. The Court has asked the parties to propose a next course of action and submit the same to the court. The Company said it is complying with the order of the Court and simultaneously evaluating all possible options to resolve the matter at the earliest. ]]> <![CDATA[Hot Start-up: Battling cholesterol with novel probiotics]]> https://biospectrumindia.com/features/95/7815/hot-start-up-battling-cholesterol-with-novel-probiotics.html https://biospectrumindia.com/features/95/7815/hot-start-up-battling-cholesterol-with-novel-probiotics.html Thu, 12 Nov 2015 12:48:06 +0530 Cholesterol is one of the leading factors behind all the heart diseases across the globe. According to a report by World Health Organizations (WHO), cardiovascular diseases (CVDs) are the number one cause of death globally, and more people die annually from CVDs than from any other cause. Over three quarters of CVD deaths take place in low- and middle-income countries. In 2012 alone, 17.5 million people died from CVDs representing 31% of all global deaths. Globally, India seems to be leading in two of the major ailments - diabetes and heart diseases. Aware of this trend, 25-year-old Mr Hrishikesh Mungi is working hard at his lab at NCL (National Chemical Laboratory), Pune, on solving one of India's major health threats. In 2012, after graduating with an Engineering degree in Biotechnology from KLE Engineering College, Belgaum, Mr Mungi was selected to work on a project on the extraction of bile salts hydrolase enzyme at NCL. "We soon realized the commercial potential of our research," says Mr Mungi. His guide, Dr Archana V Pundle, a chief scientist at NCL was the first to point out the research's commercial viability. Mr Mungi continues, "We then applied for a patent with the help of NCL. We put together a business plan including market survey and future goals for building a commercial enterprise." The research work was selected by BIRAC (Biotechnology Industry Research Assistance Council) for funding the project further through its BIG (Biotechnology Ignition Grant) scheme. In June 2014, Abhiruchi Probiotics was incorporated by Mr Mungi, with Dr Pundle serving as a scientific advisor and non-executive director of the start-up. Abhiruchi is a technologically-driven start-up, involved in developing novel probiotic products having health benefits. Investments worth Rs 50 lakh has been invested in the company so far. It is currently focusing on developing, manufacturing and commercializing of a cholesterol-lowering probiotic formulation without any side effects on the body. The company has now acquired provisional patent for lowering cholesterol by the application of probiotics. "At the moment we are validating the technology, and it'd take another 5 years for the products to reach the market," adds Mr Mungi, who enjoys playing Cricket. Mr Mungi's father and grandfather were also entrepreneurs who inspired him to actively pursue entrepreneurship since his early childhood. He bagged the 'Young Entrepreneur Award' at Eureka 2014, a business model competition conducted by IIT-Bombay. While developing the technology at NCL, Mr Mungi worked hard for a monthly pay as little as Rs 8000. At times he had to wait patiently for months together to receive his salary. Talking about the challenges faced, Mr Mungi voices, "Adapting to the mode of operation at the incubator center was challenging initially. Also it was grappling to maintain a balance between research and business documentation processes. Procuring materials and equipments from vendors in terms of quality and price was a huge task." Abhiruchi now is looking to collaborate with companies, research institutes, academia and the industry to carry out clinical trials on its products. It is also seeking active partnerships to optimize and scale-up its fermentation process, and diversify its R&D. However, it is not expecting to expand internationally at least for the next 5 years. He has a couple of recommendations for the Government when it comes to supporting start-ups. "The Government needs to redesign DSIR (Department of Scientific and Industrial Research) recognition requirement by DST (Department of Science & Technology), DBT (Department of Biotechnology), and ICMR (Indian Council of Medical Research) while acquiring grants for start-ups, which are available for Government-aided labs. The Government should also support start-ups to acquire equipments and temporary manpower through grants provided by DST, DBT, and ICMR. But again, this facility is available for Government-aided labs," Mr Mungi opines, who looks at Mr Warren Buffet as his entrepreneurial model. He also firmly believes that for a start-up, validating the idea thoroughly by various means especially with respect to market requirements is crucial. He signs-off by saying, "We need to drop the idea of being born for something. With hard work and patience, everything can become one's life goal." Essential Entrepreneurial Qualities: ï‚§ Being flexible ï‚§ Innovative thinkingï‚§ Patienceï‚§ Persistenceï‚§ Working smart Entrepreneurial Lessons Learnt Through: ï‚§ Committing errorsï‚§ Reading booksï‚§ Talking to people Why Pune Is An Emerging Start-up Hub? ï‚§ Availability of raw materials and equipmentsï‚§ Intellectual supportï‚§ Presence of fine academic and research institutesï‚§ Skilled manpower ]]> <![CDATA[FDA nod for Gilead's HIV drug]]> https://biospectrumindia.com/news/95/7281/fda-nod-for-gileads-hiv-drug.html https://biospectrumindia.com/news/95/7281/fda-nod-for-gileads-hiv-drug.html Wed, 11 Nov 2015 16:42:57 +0530 Gilead Sciences has announced today that the US Food and Drug Administration (US FDA) has approved Genvoya(elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir alafenamide 10 mg or E/C/F/TAF) for the treatment of HIV-1 infection. Genvoya is the first TAF-based regimen to receive FDA approval. Genvoya is indicated as a complete regimen for the treatment of HIV-1 infection in adults and pediatric patients 12 years of age and older who have no antiretroviral treatment history or to replace the current antiretroviral regimen in those who are virologically-suppressed (HIV-1 RNA levels less than 50 copies per mL) on a stable antiretroviral regimen for at least six months with no history of treatment failure and no known substitutions associated with resistance to the individual components of Genvoya. No dosage adjustment of Genvoya is required in patients with estimated creatinine clearance greater than or equal to 30 mL per minute. Genvoya has a boxed warning in its product label regarding the risks of lactic acidosis/severe hepatomegaly with steatosis, and post treatment acute exacerbation of hepatitis B. TAF is a novel targeted prodrug of tenofovir that has demonstrated high antiviral efficacy similar to and at a dose less than one-tenth that of Gilead's Viread(tenofovir disoproxil fumarate, TDF), as well as improvement in surrogate laboratory markers of renal and bone safety as compared to TDF in clinical trials in combination with other antiretroviral agents. Data show that because TAF enters cells, including HIV-infected cells, more efficiently than TDF, it can be given at a lower dose and there is 91 percent less tenofovir in the bloodstream. Genvoya was studied in a Phase 3 HIV clinical program in more than 3,500 patients across 21 countries, including treatment-naÃ¯ve, virologically suppressed, renally impaired and adolescent patients. The approval is supported by 48-week data from two Phase 3 double-blind studies (Studies 104 and 111) among 1,733 treatment-naÃ¯ve patients in which the regimen met its primary objective of non-inferiority compared to Stribild (elvitegravir 150 mg, cobicistat 150 mg, emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg or E/C/F/TDF). In the combined analysis of the studies, 92.4 percent of Genvoya patients and 90.4 percent of Stribild patients had HIV-1 RNA levels less than 50 copies/mL at Week 48. Tests of certain renal and bone laboratory parameters also favored Genvoya over Stribild. "While exceptional progress has been made in the field of HIV, there is still a need for new treatment options that may help improve the health of people as they grow older with the disease," said Dr John C Martin,chairman and CEO, Gilead Sciences. "For more than 25 years, Gilead has been committed to changing the trajectory of HIV management and we are now pleased to introduce Genvoya, the first in a portfolio of TAF-based products that have the potential to advance the long-term treatment of HIV." ]]> <![CDATA[TPP is a bad deal for medicine: MSF]]> https://biospectrumindia.com/news/95/7222/tpp-is-a-bad-deal-for-medicine-msf.html https://biospectrumindia.com/news/95/7222/tpp-is-a-bad-deal-for-medicine-msf.html Wed, 11 Nov 2015 13:06:25 +0530 The Trans-Pacific Partnership (TPP) is a trade agreement negotiated between the US and eleven other Pacific Rim nations: Australia, Brunei Darussalam, Canada, Chile, Japan, Malaysia, Mexico, New Zealand, Peru, Singapore and Vietnam. After more than five years of negotiations conducted in secret without the opportunity for public review, the agreed text, which will now be submitted to national processes for final signature and ratification, has been officially and publicly released. Doctors Without Borders/MÃ©decins Sans FrontiÃ¨res (MSF) remains extremely concerned about the inclusion of dangerous provisions that would dismantle public health safeguards enshrined in international law and restrict access to price-lowering generic medicines for millions of people. MSF statement by Ms Judit R Sanjuan, US manager and legal policy advisor for MSF's Access Campaign: "MSF remains gravely concerned about the effects that the Trans-Pacific Partnership trade deal will have on access to affordable medicines for millions of people, if it is enacted. The official release of the agreed TPP text confirms that the deal will further delay price-lowering generic competition by extending and strengthening monopoly market protections for pharmaceutical companies. The TPP is a bad deal for medicine: it's bad for humanitarian medical treatment providers such as MSF, and it's bad for people who need access to affordable medicines around the world, including in the United States. At a time when the high price of life-saving medicines and vaccines is increasingly recognized as a barrier to effective medical care, it is very concerning to see that the US government and pharmaceutical companies have succeeded in locking in rules that will keep medicine prices high for longer and limit the tools that governments and civil society have to try to increase generic competition. For example, if enacted, the TPP will not allow national regulatory authorities to use existing data that demonstrates a biological product's safety and efficacy to authorize the sale of competitor products, even in the absence of patents. The TPP would also force governments to extend existing patent monopolies beyond current 20-year terms at the request of pharmaceutical companies, and to redefine what type of medicine deserves a patent, including mandating the granting of new patents for modifications of existing medicines. The provisions in the TPP text will not only raise the price of medicines and cause unnecessary suffering, but they also represent a complete departure from the US government's previous commitments to global health, including safeguards included in the US's 2007 'New Trade Policy.' It is not too late to prevent further restrictions on access to affordable medicines in the TPP. As the text now goes to national legislatures for final approval, we urge all TPP governments to carefully consider whether the agreed TPP text reflects the direction they want to take on access to affordable medicines and promotion of biomedical innovation; if it does not, the TPP should be modified or rejected." ]]> <![CDATA[Janssen boosts metabolism portfolio with Hanmi deal ]]> https://biospectrumindia.com/news/95/7144/janssen-boosts-metabolism-portfolio-with-hanmi-deal-.html https://biospectrumindia.com/news/95/7144/janssen-boosts-metabolism-portfolio-with-hanmi-deal-.html Wed, 11 Nov 2015 11:43:41 +0530 Janssen Pharmaceuticals (Janssen) has announced that it has obtained worldwide rights, excluding China and Korea, to develop and commercialize oxyntomodulin-based therapies including HM12525A, a biologic that is completing phase 1 and expected to enter phase 2 studies next year, from Hanmi Pharmaceutical. The agreement is subject to clearance under the Hart-Scott-Rodino Antitrust Improvements Act and other customary closing conditions. HM12525A is an oxyntomodulin-based therapy (GLP-1/glucagon receptor dual agonist) that has shown evidence of improving multiple metabolic parameters that lead to improved blood glucose, body weight, and insulin sensitivity. This asset has the potential, as a once weekly therapy, to be a best-in-class oxyntomodulin-based therapy. "We are very excited about this agreement with Hanmi and the potential of HM12525A to improve therapeutic options for people living with metabolic diseases," said Dr James List, global therapeutic area head, Cardiovascular and Metabolism, Janssen. He added, "Our deep scientific expertise and demonstrated clinical development capabilities support our commitment to aggressively develop and launch transformational therapies for patients with cardiovascular and metabolic diseases. We look forward to developing this potential best-in-class therapy, which allows us to build on our success in diabetes and strengthen our metabolism portfolio." ]]> <![CDATA[Roche introduces new staining solution ]]> https://biospectrumindia.com/news/95/7166/roche-introduces-new-staining-solution-.html https://biospectrumindia.com/news/95/7166/roche-introduces-new-staining-solution-.html Wed, 11 Nov 2015 11:39:13 +0530 Roche has announced the launch of the VENTANA HE 600 system, the latest fully automated hematoxylin and eosin (H&E) tissue staining system. The VENTANA HE 600 system delivers fresh reagents on each individual slide without relying on user-supplied alcohol and deionized (DI) water, resulting in improved consistency and quality in tissue staining. This individual slide staining technology mitigates the risk of specimen cross contamination that can occur with other technologies, helping to reduce patient misdiagnosis. The VENTANA HE 600 system's elimination of xylene and alcohol and its utilization of ready-to-use reagents reduce technician exposure to these harmful chemicals. The system improves workflow by eliminating the need to manually mix reagents and track product expiration dates. The system offers more than 400 individual staining protocols and is fully customizable, allowing for laboratory and pathologists' preferences and tissue variables. In a recent global test, more than 4,000 slides from laboratories in 12 countries were stained on the VENTANA HE 600 system and reviewed by 67 pathologists with excellent results. Evaluation of the criteria, including nuclear detail and stain quality and intensity, resulted in a score of 3.7 on a scale of 4.0. "Approximately eighty percent of a pathologist's diagnostic report comes from the H&E stain. The VENTANA HE 600 system will help change the standard of care for laboratories, pathologists and, most importantly, cancer patients, who rely heavily on the H&E test," said Mr Roland Diggelmann, COO, Roche Diagnostics Division. He added, "The system reflects Roche's commitment to delivering innovation that meets the labs' needs of today and tomorrow through meaningful advancements in staining quality, patient and laboratory safety and workflow." The VENTANA HE 600 system currently is available worldwide with the exception of Latin America, where it will become available in early 2016. ]]> <![CDATA[AstraZeneca to buy ZS Pharma]]> https://biospectrumindia.com/news/95/7510/astrazeneca-to-buy-zs-pharma.html https://biospectrumindia.com/news/95/7510/astrazeneca-to-buy-zs-pharma.html Tue, 10 Nov 2015 22:00:00 +0530 AstraZeneca has announced that it has entered into a definitive agreement to acquire ZS Pharma, a biopharmaceutical company based in San Mateo, California. ZS Pharma uses its proprietary ion-trap technology to develop novel treatments for hyperkalaemia (high potassium levels), a serious condition of elevated potassium in the bloodstream, typically associated with chronic kidney disease (CKD) and chronic heart failure (CHF). The transaction will give AstraZeneca access to the potassium-binding compound ZS-9, a potential best-in-class treatment for hyperkalaemia, a condition associated with increased mortality in CKD and CHF. ZS-9 is under regulatory review by the US Food and Drug Administration with a Prescription Drug User Fee Act goal date of 26 May 2016. A submission for European Marketing Application Authorization is planned by the end of 2015. Current estimates for global peak year sales of ZS-9 exceed $1 billion. Mr Pascal Soriot, CEO of AstraZeneca, said, "Hyperkalaemia can be a life-threatening condition for patients with chronic kidney disease and chronic heart failure, however the risk is underappreciated and prevalence is increasing. This acquisition complements our strategic focus on Cardiovascular and Metabolic Disease by adding a potential best-in-class treatment to our portfolio of innovative medicines. We look forward to welcoming the ZS Pharma team to AstraZeneca." Under the terms of the agreement, AstraZeneca will acquire all of the outstanding capital stock of ZS Pharma for $90 per share in an all-cash transaction, or approximately $2.7 billion in aggregate transaction value. Upon completion, ZS Pharma, which has around 200 employees across three sites in California, Texas and Colorado, will become a wholly owned subsidiary of AstraZeneca. Mr Robert Alexander, CEO, ZS Pharma, said, "This agreement will allow us to maximize the potential of ZS-9, drawing on AstraZeneca's long-standing expertise in developing and commercializing medicines for cardiovascular and metabolic diseases. We look forward to joining AstraZeneca and to working together to bring this important treatment for hyperkalaemia to the global market, helping to meet an important unmet medical need for patients." ]]> <![CDATA[Cipla appoints independent director on its board]]> https://biospectrumindia.com/news/95/7447/cipla-appoints-independent-director-on-its-board.html https://biospectrumindia.com/news/95/7447/cipla-appoints-independent-director-on-its-board.html Mon, 09 Nov 2015 12:58:06 +0530 An MBA from Harvard Business School, Ms Kidwai is recognized as an influential player in the banking and financial services industry. Repeatedly ranked in the Fortune global list of Top Women in Business, she has also been on the Wall Street Journal and Financial Times Global List of Women to Watch and was listed by Time Magazine as one of their 15 Global Influentials 2002. She received the Padma Shri Award in 2007 from the Government of India for her contribution to Trade and Industry. Until recently Ms Naina Lal Kidwai was Executive Director on the Board of Hong Kong and Shanghai Banking Corporation Limited (HSBC) and was Chairman of HSBC India. She is non-executive Director on the Board of Nestle SA and member of the Audit Committee and the Chairman's and Corporate Governance Committee for Asset Liability Management. She is also a global advisor Harvard Business School and Chairman of its South Asia Advisory Board. A past President of FICCI, Ms Kidwai is the Chairperson of the FICCI Water Mission, FICCI Inclusive Governance Council and the India Sanitation Coalition. Her interests in the environment also include being on the Shakthi Sustainable foundation board and a Global Commissioner for the Climate and Economy. Ms Kidwai has edited 2 books "Contemporary Banking in India" and "30 Women CEOs: Their Voices, Their Stories". ]]> <![CDATA[GSK's Nucala receives approval from the FDA ]]> https://biospectrumindia.com/news/95/6548/gsks-nucala-receives-approval-from-the-fda-.html https://biospectrumindia.com/news/95/6548/gsks-nucala-receives-approval-from-the-fda-.html Mon, 09 Nov 2015 11:38:52 +0530 GlaxoSmithKline (GSK) has received approval from the US Food and Drug Administration (US FDA) for its Biologics License Application (BLA) for Nucala (mepolizumab) as an add-on maintenance treatment of patients with severe asthma aged 12 years and older, and with an eosinophilic phenotype. Nucala is not approved for the treatment of other eosinophilic conditions or relief of acute bronchospasm or status asthmaticus. Nucala is the first and only approved biologic therapy that targets interleukin-5 (IL-5), which plays an important role in regulating the function of eosinophils, an inflammatory cell known to be important in asthma. It is administered as a 100mg fixed dose subcutaneous injection every four weeks. Patients will receive Nucala in addition to their normal medications for severe asthma, which include high-dose inhaled corticosteroids plus at least one additional asthma control medicine, and may include oral corticosteroids. This is said to be the first marketing authorization granted for mepolizumab anywhere in the world. Mr Eric Dube, senior vice-president and head, GSK Global Respiratory Franchise, said, "Following today's approval, GSK can now offer, as part of our overall respiratory portfolio, a first-in-class biologic treatment for severe asthma patients whose condition is driven by eosinophilic inflammation. Our research has allowed us to better understand the specific role eosinophils play in severe asthma. We are proud of our contribution to this emerging area of science that has led to the approval of the first anti-IL5 treatment. We aim to offer this medicine to patients as soon as possible." Patients who were shown to benefit from treatment with mepolizumab in the Phase III clinical trials were those with blood eosinophil levels of 150 cells/mcL or greater just prior to treatment. Further information on eosinophil data is included within the approved prescribing information. Professor Ian Pavord, University of Oxford, lead investigator of the first proof of concept trial for mepolizumab and an investigator for the Phase III MENSA study said, "Severe asthma is a debilitating condition in which patients are at high risk of frequent and serious asthma attacks. Half of all severe asthma patients have at least one urgent care visit per year. As a clinician, the prospect of a treatment that can specifically target the underlying cause of the disease for patients whose condition is driven by eosinophilic inflammation is exciting." ]]> <![CDATA[Glenmark bags another FDA approval ]]> https://biospectrumindia.com/news/95/7464/glenmark-bags-another-fda-approval-.html https://biospectrumindia.com/news/95/7464/glenmark-bags-another-fda-approval-.html Mon, 09 Nov 2015 11:21:13 +0530 Glenmark Pharmaceuticals USA (Glenmark) has been granted final approval by the United States Food and Drug Administration (US FDA) for Clotrimazole and Betamethasone Dipropionate Cream USP, 1 percent|0.05 percent. The drug is the therapeutic equivalent of Lotrisone Cream USP, 1 percent|0.05 percent of Merck, Sharp and Dohme Corporation. According to IMS Health sales data for the 12 month period ending September 2015, the Lotrisone Cream USP, 1 percent|0.05 percent market achieved annual sales of approximately $82.4 million. ]]> <![CDATA[FDA issues warning letter to Dr Reddy's]]> https://biospectrumindia.com/news/95/3868/fda-issues-warning-letter-to-dr-reddys.html https://biospectrumindia.com/news/95/3868/fda-issues-warning-letter-to-dr-reddys.html Mon, 09 Nov 2015 11:20:08 +0530 Dr Reddy's Laboratories has received a warning letter issued by the US FDA dated November 05, 2015 relating to its API manufacturing facilities at Srikakulam, Andhra Pradesh and Miryalaguda, Telangana, as well as Oncology Formulation manufacturing facility at Duvvada, Visakhapatnam, Andhra Pradesh. This action follows the earlier inspections of these sites by the agency in November 2014, January 2015 and February 2015 respectively. Dr Reddy's CEO, Mr G V Prasad said, "We take quality and compliance matters seriously and stand by our commitment to fully comply with the cGMP quality standards across all of our facilities. We will respond with a comprehensive plan to address these observations within the stipulated time-frame of 15 days. We will continue to actively engage with the agency to resolve these issues and we have also embarked on an initiative to revamp our quality systems and processes, as an organization-wide priority." ]]> <![CDATA[Piramal acquires Little's, a Baby Care Brand ]]> https://biospectrumindia.com/news/95/7645/piramal-acquires-littles-a-baby-care-brand-.html https://biospectrumindia.com/news/95/7645/piramal-acquires-littles-a-baby-care-brand-.html Fri, 06 Nov 2015 13:18:46 +0530 Piramal Enterprises' Consumer Products Division announces the acquisition of the baby-care brand "Little's", which includes the entire product range across six categories. Mr Kedar Rajadnye, COO, Piramal Enterprises - Consumer Products Division said, "At Piramal Consumer Products, we started our journey in 2009 as an independent player and ranked 40th in the OTC category in India. Over the last 6 years, the business has grown rapidly at 24 percent and is now ranked 7th amongst all OTC companies in India. We have built a portfolio of strong brands of which six are among the Top 100 OTC brands in India. Our brands like Saridon, i-Pill, Lacto Calamine, Polycrol, Tetmosol and Caladryl have a strong consumer franchise and all are either a no.1 or no.2 player in their respective categories." "In line with our strategy, we aim to be a Top 3 player in the OTC market by 2020 and we believe that Little's will help us achieve this goal. Currently, we cater to the 5-10 age groups through the Jungle Magic brand. With this acquisition, we now have an offering for babies in the 0-4 age group. This allows us to partner with mothers and provide well-being solutions for their children right from their birth till they reach the age of 10 years." added Kedar. The company said Little's has the potential to become a power brand, given the Piramal's sales and marketing strengths. The brand will leverage the distribution network of the Consumer Products Division, which currently covers towns that have a population in excess of 1 lakh in India. Mr Darshan Deora, managing director - Little's said "We are very pleased that Little's brand is being acquired by Piramal Enterprises, which is one of the leading conglomerates in India. Little's has grown considerably over the years and today it is one of the most promising brands in the baby-care segment. Piramal's Consumer Products Division, which has one of the best distribution networks in India, is the perfect partner to take Little's to new heights. Piramal team has a proven track record with their other brands as well. I wish them all the best for the future." ]]> <![CDATA[Johnson & Johnson to acquire Novira Therapeutic ]]> https://biospectrumindia.com/news/95/7109/johnson-johnson-to-acquire-novira-therapeutic-.html https://biospectrumindia.com/news/95/7109/johnson-johnson-to-acquire-novira-therapeutic-.html Fri, 06 Nov 2015 12:32:05 +0530 Johnson & Johnson has announced a definitive agreement to acquire Novira Therapeutics, a privately held, clinical-stage biopharmaceutical company developing novel therapies for curative treatment of chronic hepatitis B virus (HBV) infection. The acquisition includes Novira's portfolio of novel antivirals, including its lead candidate, NVR 3-778. Financial terms of the transaction have not been disclosed. NVR 3-778 is a small molecule, direct acting antiviral, for oral administration in patients with HBV that inhibits the HBV core or capsid protein. HBV core is a novel and promising drug target since it is involved in multiple activities required for viral replication and persistence. "We are excited about the prospect this acquisition offers to accelerate the development of curative treatments for people affected by chronic hepatitis B," said Dr William N Hait, global head, R&D, Janssen Pharmaceutical Companies of Johnson & Johnson. "NVR 3-778 offers the potential for efficient suppression of virus production and replication, which could help address the remaining unmet medical needs." The closing is subject to clearance under the Hart-Scott-Rodino Antitrust Improvements Act and other customary closing conditions. The transaction is expected to close during the fourth quarter of 2015. "Chronic Hepatitis B is a potentially fatal liver disease with approximately 60 percent of hepatocellular carcinoma attributed to infection with the Hepatitis B virus," said Dr Lawrence Blatt, global head, Infectious Diseases and Vaccines, Janssen and chief executive officer, Alios Biopharma, part of the Janssen Pharmaceutical Companies. "With more than 350 million people affected worldwide we seek to overcome treatment challenges, such as the requirement for people to endure lifelong therapy, through scientific innovation. Combining Novira's recent breakthroughs with our vast experience in viral diseases we endeavor to deliver novel medicines for patients suffering from this insidious disease". ]]> <![CDATA[17 MoUs signed between NIPERs and Pharma Industry]]> https://biospectrumindia.com/news/95/7214/17-mous-signed-between-nipers-and-pharma-industry.html https://biospectrumindia.com/news/95/7214/17-mous-signed-between-nipers-and-pharma-industry.html Fri, 06 Nov 2015 11:46:12 +0530 Seven National Institutes for Pharmaceutical Education and Research (NIPERs) have undertaken Academia-Industry linkage with 17 Pharma Industries of Private and Public sector. These 7 NIPERs exchanged MOUs with industry heads in the presence of honorable president of India Mr Pranab Mukherjee on 4th November 2015 as a part of Visitors conference being held now 4-6th November 2015. During the event, a total of 45 MOUs were exchanged between Central Institutions viz., IITs, NIPERs, IISERs, IIITs, IISc-B, NIFT, NITs, RGIPT, RGNIYD & SPAs. Of the 45, 17 are under Pharmaceuticals sector. Thus the initiative of Department of Pharmaceuticals stands out. NIPERs have signed 17 agreements with drug firms, including Dr Reddys, Sun Pharma, Wockhardt, Panacea Biotech, Medley Pharmaceuticals, Johnson & Johnson, Cadila Healthcare (Zyudus), Bharat Biotech, Cadila Pharmaceuticals, NATCO, Sahjanand Technologies. Department of Pharmaceuticals is drawing up a common road map for Drug Discovery through convergence and synergy involving all stakeholders. The department has identified that Academia-Industry linkage as a basic requirement for translating research into development (commercialization) and Innovation; and also to fix accountability among the Educational Institutions. ]]> <![CDATA[Lupin appoints new president for EMEA]]> https://biospectrumindia.com/news/95/6561/lupin-appoints-new-president-for-emea.html https://biospectrumindia.com/news/95/6561/lupin-appoints-new-president-for-emea.html Fri, 06 Nov 2015 11:44:30 +0530 Pharma major Lupin has announced the appointment of Mr Thierry Volle as president of Europe, Middle-East and Africa (EMEA). At Lupin, Mr Thierry will be responsible for the company's growth and development in Europe, Russia and CIS, and Middle-East and African markets. He will be based at Lupin's European headquarters in Zug, Switzerland. Mr Thierry joins Lupin from Vifor Pharma where he was the head of EU and International business operations. Prior to that, he was at Wyeth and worked his way through multiple roles of increasing responsibility in Europe as well as the corporate headquarters in St. Davids, PA. Mr Thierry has extensive international experience in building and growing specialty pharmaceuticals businesses across markets specifically in EMEA, with a focus on business and market development, integration and change management and product portfolio management. He holds a Business diploma from Institut SupÃ©rieur de Gestion and a Master's degree in Computer Science from Centre d'Ã©tudes supÃ©rieures industrielles- Centrale, Paris and has also completed various Executive Programs at the Harvard School of Public Health, INSEAD and EPFL to name a few. Commenting on the appointment Ms Vinita Gupta, CEO, Lupin, said, "We are delighted to have Mr Thierry join the Lupin family. His rich knowledge and experience in developing and growing businesses, specifically specialty pharmaceuticals in EMEA, will help us with our strategic expansion plans for these markets." ]]> <![CDATA[Sanofi, Hanmi to co-develop diabetes treatments]]> https://biospectrumindia.com/news/95/5340/sanofi-hanmi-to-co-develop-diabetes-treatments.html https://biospectrumindia.com/news/95/5340/sanofi-hanmi-to-co-develop-diabetes-treatments.html Fri, 06 Nov 2015 11:43:08 +0530 Sanofi and Hanmi Pharmaceutical has announced a worldwide license agreement to develop a portfolio of experimental, long-acting diabetes treatments. Under the terms of the agreement, Hanmi will receive an upfront payment of â‚¬400 million (or $435 million) and is eligible for up to â‚¬3.5 billion (or $3.80 billion) in development, registration and sales milestones, as well as double digit royalties on net sales. Sanofi will obtain an exclusive worldwide license to develop and commercialize 1.) efpeglenatide, a late-stage long-acting glucagon-like peptide-1 receptor agonists (GLP1-RA); 2.) a weekly insulin and 3.) a fixed-dosed weekly GLP-1-RA/insulin drug combination. Collectively, these therapeutic offerings are known as the "Quantum Project" utilizing Hanmi's proprietary Long Acting Protein / Peptide Discovery Platform LAPSCOVERY technology. Hanmi will retain an exclusive option to co-commercialize the products in Korea and China. "The agreement to develop these three investigational diabetes medicines confirms Sanofi's long-term commitment to people with this disease," said Ms Pascale Witz, executive vice-president, Sanofi, who will lead the Global Diabetes and Cardiovascular Care Business Unit in the company's new organizational structure. She added, "We now have the opportunity to expand our existing portfolio by including medicines that are administered weekly as well as daily, which could extend our reach in basal insulin and expand our GLP-1-RA and GLP-RA/insulin combination prospects. In these ways, we aim to complement our current offerings and work to serve a broader patient population." The Quantum Portfolio is based on Hanmi's proprietary LAPSCOVERY (Long Acting Protein/Peptide Discovery) Technology which is a platform technology that prolongs the duration of action of biologics. The objective is to minimize the frequency of treatment and the dose required, thereby potentially lowering the adverse event rates and optimizing efficacy, according to Hamni. "We are pleased that Sanofi with its long heritage and as a proven leader with solid track of success in diabetes, has recognized the value of Hanmi's Quantum Project," said Dr Gwan Sun Lee, CEO/president of Hanmi Pharmaceutical. "We are confident that we have found the right partner and are excited for the potential this license agreement with Sanofi will bring to the development of Hanmi's Quantum Project and possibilities this could offer to people with diabetes." Hanmi presented data from five clinical and non-clinical studies on efpeglenatide at the 75th ADA Scientific Session in June. The agreement is subject to customary closing conditions including review under the Hart-Scott-Rodino Antitrust Improvements Act. ]]> <![CDATA[IPC set to become first WHO Collaborating Centre for Safety of Medicines and Vaccines in Asia Pacific]]> https://biospectrumindia.com/news/95/7730/ipc-set-to-become-first-who-collaborating-centre-for-safety-of-medicines-and-vaccines-in-asia-pacific.html https://biospectrumindia.com/news/95/7730/ipc-set-to-become-first-who-collaborating-centre-for-safety-of-medicines-and-vaccines-in-asia-pacific.html Thu, 05 Nov 2015 14:47:00 +0530 Hosted annually by one of the World Health Organization (WHO) member states, the 38th Annual Meeting of Representatives of the National Pharmacovigilance Centres acted as a platform for countries to discuss current issues and concerns in pharmacovigilance. This year, the meeting has been hosted by the Indian Pharmacopoeia Commission, the National Coordinating Centre - Pharmacovigilance Programme of India with active support from WHO from 4-6 November 2015. More than 150 international delegates from over 57 countries are attending the meeting. The opening day of the meeting witnessed participation of delegates from regulatory agencies, academic institutions, collaborating centres, member states and industry. Problems of current interest, several areas of critical importance and advancements in pharmacovigilance were deliberated. Over the past 30 years, the network of pharmacovigilance centres has grown immensely and the annual meetings have become a significant forum for discussions on advancement made in the area of safe medicines. The 37th Annual Meeting in 2014 was held in China, hosted by the Chinese Food and Drug Authority. In his inaugural address, Mr J P Nadda, union minister for health and family welfare emphasized that the success of pharmacovigilance depends on the state of art reporting, cutting edge use of information and communications technology to process and analyze information for immediate corrective measures, which needs to be supported by a highly calibrated audit process. The Minister applauded the WHO Collaborating Centres across the globe, which serve as platforms for knowledge transfer and act as catalysts for developing the next level good pharmacovigilance practices and awareness of adverse drug reactions and their reporting. In her message, Dr Poonam Khetrapal Singh, Regional Director, WHO South-East Asia Region said, "The meeting is timely and expected to facilitate partnerships between WHO Member States, collaborating centres of WHO, Adverse Drug Reaction monitoring centres of the Pharmacovigilance Programme of India, industry and research institutions to showcase best practices of pharmacovigilance towards ensuring safetyof medicines." Speaking on the occasion, MrBhanu Pratap Sharma, secretary, Ministry of Health and Family Welfare (MoHFW) highlighted that there are several challenges inmedical sector and public health systems that have heightened the need forpharmacovigilance, such as medicines coming from countries where regulatory standards may not be very strong, increasingly dependence of people on online platforms for medical guidance and self-medication etc. ]]> <![CDATA[Project Ä€SMÄ€N aims to reduce maternal & newborn mortality in India]]> https://biospectrumindia.com/news/95/7224/project-smn-aims-to-reduce-maternal-newborn-mortality-in-india.html https://biospectrumindia.com/news/95/7224/project-smn-aims-to-reduce-maternal-newborn-mortality-in-india.html Thu, 05 Nov 2015 14:35:00 +0530 Project Ä€SMÄ€N, a major healthcare initiative aimed at reducing infant, neonatal and maternal mortality in India, was launched on November 3, 2015 by a consortium of leading private and development sector partners. The initiative is an alliance between the Bill & Melinda Gates Foundation, MSD India (through its MSD for Mothers programme), Reliance Foundation, Tata Trusts and the United States Agency for International Development (USAID). It is important to note that India is the world's second most populated country and observes over 30 million pregnancies every year. Of this, 27 million women reach the stage of delivery and over 56,000 mothers die during or within 48 hours of delivery. The first 48 hours are equally critical for the child, as 50 percent of neonatal deaths happen in the first 48 hours. Presently, the states most acutely affected by concerns of Maternal Mortality Rate (MMR), Neonatal Mortality Rate (NMR) and Infant Mortality Rate (IMR) are Bihar, Uttar Pradesh, Rajasthan and Madhya Pradesh. Commenting on the partnership of the Bill & Melinda Gates Foundation with Ä€SMÄ€N, Mr Alkesh Wadhwani, Deputy Director, Integrated Delivery, India, Bill & Melinda Gates Foundation, said, "The foundation is deeply committed to improving maternal and child health in India. We believe that the health of mothers and children merits particular attention, given India's share of the overall burden of maternal and child mortality, and we have made it the focus of our work in India. We decided to partner with Ä€SMÄ€N because we strongly believe the combined efforts of our alliance will help significantly advance our collective commitment of expanding access to maternal and child health in India and help ensure that women and children not only survive but thrive. Through this alliance, our foundation will continue its commitment of partnering the government in achieving its ambitious goals to improve women and child health and prioritise equitable growth." ASMAN was jointly unveiled by Mr Alkesh Wadhwani, deputy director, Integrated Delivery, India, Bill & Melinda Gates Foundation, Mr Kenneth C Frazier, chairman and CEO, MSD, Ms Nita Ambani, founder and chairperson, Reliance Foundation, Mr R K Krishna Kumar, Trustee - Tata Trusts, and Ambassador Jonathan Addleton, mission director, USAID/India, at a special event in the presence of Ms Maneka Gandhi, minister for Women and Child Development, Government of India, and Dr Jagdish Prasad, Director General Health Services, Ministry of Health & Family Welfare, Government of India. Project Ä€SMÄ€N will work towards facilitating the availability of quality healthcare under the five pillars of the Government of India's Reproductive, Maternal, Newborn, Child Health and Adolescent Health Program (RMNCH+A). Committed to reducing infant, neonatal and maternal mortality rates in India, the Ä€SMÄ€N programme brings together the knowledge and expertise of each partner to create customised solutions for addressing state-specific requirements. In line with the government's agenda of reducing mortality rates, this first-of-a-kind alliance will support the introduction and implementation of high impact interventions at the health facility level. Mr Kenneth Frazier, chairman and CEO, MSD mentioned, "We must never lose focus on the health of mothers and children, even one preventable death is unacceptable. Through our MSD for Mothers initiative we are working every day to help create a world where no woman dies giving life. And, by sharing MSD's scientific and business expertise in this partnership, it is my hope that the combined strengths and contributions of all involved will help create a sustainable model for high impact solutions in India." As per Ms Nita Ambani, Founder and Chairperson, Reliance Foundation added, "I believe that every life must be cared for and we should strive for a healthy India, where no mother is lost to child birth and every child can live life to his or her fullest potential. This is possible through smart, strong and sustainable partnerships. I am proud to be part of an alliance with which Reliance Foundation shares such strong synergies - institutions that share the same passion and commitment to tackle massive national challenges on a mission mode. For me, this partnership goes beyond just funding but leveraging our rich institutional experience, valued expertise and a strong shared commitment to improving mother and child survival in India. Ä€SMÄ€N gives me hope that change is possible." Mr R K Krishna Kumar, Trustee, Tata Trusts said, "Tata Trusts for the last hundred years, have been waging a battle against Maternal, Neonatal and Child mortality. With this alliance, we offer our support through resources and infrastructure; safeguarding and promoting the health and wellbeing of every mother and child." Reaffirming USAID's commitment to ending preventable child and maternal deaths, Ambassador Jonathan Addleton, USAID , mission director to India, said: "USAID decided to partner with Ä€SMÄ€N because it brings together the right partners from across sectors whose core competencies and technical expertise can build synergies with existing programs to achieve the goal of zero mother and child deaths by 2035. Through Ä€SMÄ€N, USAID will continue to foster the power of science, technology, innovation, and partnerships to create solutions to reduce child and maternal deaths more quickly and cost effectively." ]]> <![CDATA[Dr Reddy's inks marketing pact with Biocodex]]> https://biospectrumindia.com/news/95/7295/dr-reddys-inks-marketing-pact-with-biocodex.html https://biospectrumindia.com/news/95/7295/dr-reddys-inks-marketing-pact-with-biocodex.html Thu, 05 Nov 2015 14:22:37 +0530 Dr Reddy's Laboratories has entered into a strategic alliance with Biocodex to market and distribute Biocodex products in the Romanian market. Biocodex has announced the change in partnership and effective October 1, 2015, Dr Reddy's has been given the complete rights for promotion and distribution of the Biocodex products across Romania. Earlier, AKACIA was in partnership with Biocodex for similar distribution pact. With this new collaboration coming into existence, Dr Reddy's will aim to develop the access of the Romanian patients to the Rx portfolio including Biocodex's well-known OTC products ENTEROL and OTIPAX. ENTEROL is the ethical pharmaceutical specialty composed of lyophilised Saccharomyces boulardii living cells in a concentration of 250 mg per capsule, or per sachet registered in Romania in packs of 10 capsules and sachets under the trademark ENTEROL. OTIPAX is the ethical pharmaceutical specialty presented as an ear drop solution containing phenazone and lidocaine hydrochloride, presented in bottles of 15 ml registered in Romania under the trademark OTIPAX ]]> <![CDATA[Money matters: Monsanto, Indigenous companies spar on Bt cotton trait value]]> https://biospectrumindia.com/features/95/7922/money-matters-monsanto-indigenous-companies-spar-on-bt-cotton-trait-value.html https://biospectrumindia.com/features/95/7922/money-matters-monsanto-indigenous-companies-spar-on-bt-cotton-trait-value.html Thu, 05 Nov 2015 14:20:48 +0530 From its very beginning, the Bt cotton technology in India has been at the heart of controversies mostly due to allegations leveled by activists. The interesting part this time around, however, is that the companies that were once on the same side of technology transfer partnership, are now battling it out openly. So is this the end of the bonhomie or matter will be resolved? We take a look. It all started when the group of eight companies; Prabhat Agri Biotech, Ajeet Seeds Limited, Kaveri Seeds, Ankur Seeds, Nuziveedu Seeds, Green Gold Seeds, Ram Agrigenetics and Amar Biotech decided not to pay trait value fixed over the transfer of Bt technology to Monsanto. Decision was based on their belief that earlier contract with Monsanto was no longer viable given the third party intervention in form of respective state governments who had issued price control orders. In the meantime, Monsanto India's joint venture, Mahyco-Monsanto Biotech (MMB) which of course wasn't amused at the developments, filed an arbitration petition before the Mumbai High Court for the alleged breach of contracts resulting in around Rs 400 crore payment dues. In response, the seed companies too filed a counter affidavit mentioning the fact that payment of approximately Rs 1,300 crore has been already made to MMB for trait value since the year 2010. In fact, going a step further the companies have reportedly asked for a money back. As per a source, these companies had made a request to the MMB to reconsider the trait value fixed earlier and look into accounts from 2010 onwards as in between the price orders were determined by the state governments. According to National Seeds Association of India, Monsanto did not adhere to the government orders. "Since 2010, the state governments have been specifying trait values (royalty) in their price orders as Rs 50/- for BG I and Rs 90/- for BG II. Since the year 2011, government of Maharashtra has considered the trait value as Rs 20/- for both BG I and BG II. In the year 2015, Telengana state government considered the trait value as Rs 10/- for BG I and Rs. 50/- for BG II. Going by the provisions of the legislations, the stakeholders that are the seed companies and the technology provider have no option except to follow the orders, as they were not set aside by the hon'ble courts, though there were stay orders in some states. On account of the pending litigations, in anticipation of favorable ruling the licensee seed companies deposited to MMB trait value (royalty) at higher rates than what was indicated in the state government price orders from 2010," said Dr Kalyan Goswami, executive director, NSAI. Monsanto spokesperson in his reply to the BioSpectrum was very critical of the companies. In his words, "Out of 49 licensee seed companies, a small group of 9 licensees have willfully breached legally binding and extensively negotiated license agreements by refusing to pay the agreed technology fee despite continuing to profit by using our technologies. These limited number of the licensee seed companies have sought to unilaterally reduce the trait value payable under the agreements on the basis of an erroneous interpretation of applicable law. Following our discussions with such companies, several have withdrawn their contentions and agreed to pay the contractually agreed trait value." BioSpectrum's repeated follow ups to the Indian companies for individual responses remained unanswered. The Association of Biotechnology Led Enterprises-Agriculture Group (ABLE-AG) too declined to comment on the issue. No meeting ground? While the companies say that they were willing to talk to Monsanto but the latter chose the litigation over talks, the technology giant says it was compelled into such action due to non cooperation from the seed companies. As per Monsanto it had immediately communicated to each of them for meeting individually to understand the reasons but that was refused by them as they wanted a collective meeting. "We as a group of seed companies wrote to MBB requesting for a joint meeting but it approached the court under section 9 of the Arbitration Act alleging the breach of contracts," an earlier media report had quoted Mr G V Bhaskar Rao, chairman and managing director of Kaveri Seeds, one of the companies. He also hinted at the readiness of seed companies for a long legal battle in case Monsanto doesn't agree to the demands. On being asked why Monsanto chose not to speak to these companies, its spokesperson mentioned, "All of them refused and stubbornly insisted that they will only meet collectively and only to negotiate a downward revision of the trait value. Regrettably, a few, while continuing to use MMB's technologies, have refused to pay the technology fee or trait value despite having already collected the full sales price amounts from farmers. They have intentionally withheld large sums of trait value and ignored our repeated pleas to abide by the license agreements many of which have been executed only a few months ago. It is due to these dire circumstances and in the absence of any other alternatives that MMB has been compelled to approach the Mumbai High Court for appropriate reliefs." Will the govt step in? The seed companies maintain that the issue has ceased to be as a private contract between the technology provider and the licensee as soon as the governments intervened and started fixing the trait value and the sale price of cotton seed in the country. NSAI believes that to ensure harmony and growth of seed sector and to create a competitive business environment, regulation by the ministry of agriculture in the licensing conditions including trait values (royalty) is highly essential. "Industry wants from ministry to intervene through the provisions available in the Patent Act or the Competition Act or the Environment Protection Act (Rules of GM Crops) to create the required harmonious environment," mentioned their statement. On the other hand, the Monsanto spokesperson refused to accept that the government intervention in the fixing of prices really nullified the contract as claimed by companies. He explained: "No laws including the state price control laws provide for the fixation of trait value. The Government of Telangana sought vide a government order dated May 11, 2015 to fix not only the MSPs for cotton seeds for 2015-16, but also the trait value payable to MMB by its sub-licensees. However, the High Court for the States of Andhra Pradesh and Telangana immediately issued an interim order staying the operation of the government order insofar as it sought to fix trait value. The High Court of Andhra Pradesh has also issued several other orders indicating that the state government does not have the power to fix trait value." Way forward MMB says that the vast majority of the licensee seed companies continue to enjoy a constructive business relationship built on mutual trust and respect. At the same time, irrespective of the battle they are fighting in court, the seed companies too seem to be willing to enter into discussions. Given this only positive angle to this complicate story, the industry associations on both sides must take a lead and bring the warring sides to negotiating table. From the past experiences it is clear that the mistrust will lead to further deepen this wedge which is not so good news for Indian agriculture sector in general and wider agri- biotech in particular. Given the larger stakes involving seed industry, and farming community, the harmonious collaborative efforts between technology developer and seed companies is very important. Timeline of Bt cotton technology in India 2002: Bollgard cotton became the first biotech crop technology approved for commercialization in India in More than 6 million farmers adopted the technology on their farms. 2003: Monsanto introduced a second-generation trait product in cotton with Bollgard® II insect-protected cotton in The product provides farmers with the same benefits as the original Bollgard product, as well as expanded protection against other cotton pests. 2006: Monsanto becomes the first agriculture company to introduce a stacked second-generation product, launching Bollgard II with Roundup Ready Flex cotton. The product provides farmers with the same benefits as Bollgard II, as well as the flexits Roundup Ready Flex technology. Bollgard® II -a double-gene technology-was approved by the Genetic Engineering Approval Committee. 2006: MMB, a 50:50 joint venture between Mahyco and Monsanto sub-licensed the Bollgard II and Bollgard technologies to more than 30 Indian seed companies. Each Indian seed company has introduced the Bollgard technology into their own germplasm. Indian farmers now have a choice of over 300 Bt cotton hybrid seeds. Bollgard is used by more than 6 million Indian farmers. BTeconomics cocktail involves executive and judiciary There has been gap between the government-determined trait value and the Monsanto determined trait value. According to available data, until 2014, the seed companies have paid Rs 122.96 per packet for Bollgard (BG) 1 and Rs 183.46 per packet for Bollgard 2 technologies towards the trait value to Monsanto. That was even as the governments of Telangana, Andhra Pradesh, Maharashtra and Karnataka continued to fix trait value and the sale price of cotton seed on their own terms. The trait value charged by MMBL was as high as Rs 1,200 per packet in 2005 before the state governments had entered the scene. Earlier Maharashtra government, which had fixed the trait value component at just Rs 20 per packet for both the technologies, also got a stay order vacated in a related case heard in Mumbai High Court. The state government had also reduced the sale price of 450 gram packet to Rs 830 this year from Rs 930 in 2014. Since 2010, the state governments have been specifying trait values or royalty in their price orders as Rs 50 for BG1 and Rs 90 for BG 2. Since the year 2011, the Maharashtra government has considered the trait value as Rs 20 for both BG1 and BG 2. In 2015, Telangana government has considered the trait value as Rs 10 for BG1 and Rs 50 for BG 2. The state governments did not revise the prices annually even to cover the inflation in the costs of production. While the cost of production went up year after year due to the high inflation, the MRP remained stagnant between 2006 to 2010 and again between 2011 to 2015. Thus in the last 10 years, only once the state governments enhanced the seed prices. While seed industry was expecting for price increase after four years, the Maharashtra Government reduced the sale price of Bt cotton seed by Rs 100/- in 2015. To compound the problems, the state governments never considered the contractual obligations between the MMB and the licensee seed companies and considered trait values (royalty), as they deemed appropriate. Since the price orders of the state governments are backed by legislations, the seed companies have no option but to accept the orders and follow them. Several writ petitions were filed by seed companies across the cotton growing states, which could not give any relief. ]]> <![CDATA[Successful completion of global phase I/II clinical trial for Galnobax]]> https://biospectrumindia.com/news/95/7959/successful-completion-of-global-phase-i-ii-clinical-trial-for-galnobax.html https://biospectrumindia.com/news/95/7959/successful-completion-of-global-phase-i-ii-clinical-trial-for-galnobax.html Wed, 04 Nov 2015 13:49:09 +0530 Pune-based NovaLead Pharma, a drug discovery and development company, announced a potential breakthrough in the treatment of diabetic foot ulcers (DFU), which is a frequent complication of uncontrolled diabetes over a period of time. The recently concluded global Phase I/II clinical trial of its repositioned investigational drug, Galnobax successfully met both primary and secondary end points for efficacy and safety. The scientific challenge in this discovery can be understood by the fact that the last and the only USFDA approved drug for DFU came in 1997. The gel can be self-administered at home without significant side-effects thus providing additional benefits to patients in terms of convenience and saving hospital costs In this trial, Galnobax demonstrated significant benefit over placebo in terms of ability to close hard to heal DFUs in much shorter time, making it potentially the first small molecule drug for DFU. In addition, the trial reported no side effects of any significance. The data supports anticipated mechanism of action of Galnobax that it triggers the intrinsic wound healing processes impaired in diabetics. According to the company's press release, in comparison to the published data of existing therapies like growth factors and skin grafts, Galnobax trial data is considerably superior in terms its wound closing ability as well as the time to heal. That it is self-administrable, Galnobax is likely to save expenses for the patients and also ensure better compliance. This innovation is noteworthy because Galnobax is a generic drug originally indicated for a cardiac condition, repositioned by NovaLead for DFU in a gel form for topical use. Galnobax is discovered through NovaLead's proprietary technology platform which enables systematic approach for finding novel therapeutic indications for known drug molecules. Using this platform NovaLead has generated a robust pipeline of which Galnobax is the first candidate in human trial. Galnobax has already received patents in all regulated markets namely USA, EU and Japan as well as in emerging markets like India and China. Further development of Galnobax is substantially de-risked as safety concerns are insignificant and the Phase I/II clinical trials demonstrate that its efficacy is significantly superior to placebo plus standard of care. Galnobax has recently been adjudged as the Best Innovation in Healthcare in 2015 by DBT-BIRAC which is an initiative of the Department of Biotechnology, Government of India. The company will be further developing the product through registration trial preferably along with a partner and will launch the drug in 2018. ]]> <![CDATA[Top Employers: Novozymes occupies Numero Uno spot ]]> https://biospectrumindia.com/news/95/6622/top-employers-novozymes-occupies-numero-uno-spot-.html https://biospectrumindia.com/news/95/6622/top-employers-novozymes-occupies-numero-uno-spot-.html Wed, 04 Nov 2015 12:23:12 +0530 Novozymes was ranked number one, when Science Magazine released its annual Top Employers Survey today. Science Magazine is the academic journal of the American Association for the Advancement of Science (AAAS) and one of the world's top scientific publications. The 2015 Top Employers Survey is based on 5,701 survey responses from readers of Science and other survey invitees. Survey participants came from North America (57%), Europe (27%), and Asia/Pacific Rim (11%); 92% work in biotechnology, biopharmaceutical, and pharmaceutical companies. The survey polls employees in the biotechnology, pharmaceutical, and related industries to determine the 20 best employers globally. The key driving characteristics of the ranking were 'Innovative leader in the industry', 'Treats employees with respect' and 'Is socially responsible'. "We are very proud to be recognized as the best employer by this leading scientific journal," said Dr Per Falholt, CSO at Novozymes. "We develop biological answers to some of the greatest challenges of our time. Our growing world needs more food, better farming, renewable energy, and clean air and water. Our products really make a difference, and I believe that is a great motivation for everybody at Novozymes." Novozymes has pioneered the field of industrial biotechnology since the 1940s. One in five of its 6,500 employees work in research and development (R&D), with the company's main research centers located in Denmark, China, US and India. Novozymes invests 13-14% of total revenue into R&D each year. As the world's largest maker of industrial enzymes and microorganisms, Novozymes' biotechnology is used by companies everywhere to save on energy, water and raw materials in a wide range of products. From laundry detergents, textiles and beer, to biofuels, animal feed and crops. In 2014, the worldwide application of Novozymes' biological solutions helped customers reduce their COâ‚‚ emissions by an estimated 60 million tons, equivalent to taking 25 million cars off the road. "Many answers to the world's biggest problems can be found in some of the smallest things in nature," said Dr Per Falholt. "Proteins and microorganisms have helped humans since the dawn of time. They are right there waiting for us to discover just how much biology can do to create a world in balance." ]]> <![CDATA[GSK, Merck to study immunotherapy combination as potential cancer treatment ]]> https://biospectrumindia.com/news/95/5877/gsk-merck-to-study-immunotherapy-combination-as-potential-cancer-treatment-.html https://biospectrumindia.com/news/95/5877/gsk-merck-to-study-immunotherapy-combination-as-potential-cancer-treatment-.html Wed, 04 Nov 2015 12:19:27 +0530 GSK and Merck, known as MSD outside the US and Canada, has announced the initiation of a phase I clinical trial designed to evaluate GSK's investigational immunotherapy GSK3174998 as monotherapy and in combination with Merck's anti-PD-1 therapy, Keytruda (pembrolizumab) in patients with locally advanced, recurrent or metastatic solid tumour(s) that have progressed after standard treatment. GSK3174998 is a humanised IgG1 anti-OX40 monoclonal antibody that was identified through a collaboration with MD Anderson Cancer Center. OX40 is a tumour necrosis factor receptor expressed on the surface of activated CD4+ and CD8+ T cells. OX40 agonism results in stimulation of both immune effector and memory functions, while also attenuating the immunosuppressive regulatory T cells that are sometimes found in tumours. GSK3174998 is one of a number of early stage assets in GSK's oncology pipeline focused on fighting the fundamental drivers of cancer. Keytruda is a humanised monoclonal antibody that works by increasing the ability of the body's immune system to help detect and fight tumour cells. Keytruda blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, and may affect both tumour cells and healthy cells. Dr Axel Hoos, vice president oncology R&D at GSK, said, "There have been meaningful advances in survival across several cancers recently, mostly based on single agent checkpoint modulatory drugs. The combination study of Keytruda with GSK's OX40 agonist will seek to build on that progress with the aim of contributing further improvements for patients. We think combining these two agents that use different aspects of the immune system may be an important step toward achieving this goal." "The initiation of this phase I trial with GSK is an important step in identifying synergistic treatment combinations that can potentially enhance the activity we are seeing with Keytruda as a monotherapy," said Dr Eric Rubin, vice president and therapeutic area head, oncology early stage development, Merck Research Laboratories. "We are looking forward to this trial progressing and to sharing the findings on the potential of the combination of Keytruda and GSK's GSK3174998 in bringing forward improved outcomes for patients with advanced cancer." ]]> <![CDATA[Roche expands cobas 4800 System menu with HIV-1, HCV and HCV Genotyping Tests]]> https://biospectrumindia.com/news/95/7446/roche-expands-cobas-4800-system-menu-with-hiv-1-hcv-and-hcv-genotyping-tests.html https://biospectrumindia.com/news/95/7446/roche-expands-cobas-4800-system-menu-with-hiv-1-hcv-and-hcv-genotyping-tests.html Wed, 04 Nov 2015 12:13:11 +0530 Roche has announced the commercial availability of the cobas HIV-1, HCV and HCV Genotyping (GT) assays in countries accepting the CE mark. These new molecular diagnostic assays increase the available menu on the cobas 4800 System, further improving efficiency and flexibility that allows laboratories to deliver results for rapid clinical decisions. The new virology assays offer the latest generation of performance with dual target technology for HIV-1 and dual probe technology for HCV. All of the new virology assays can run simultaneously on the cobas 4800 System, with optimized sample processing volumes for streamlining workflow that increases flexibility for patient sample management. With these additions, the cobas 4800 System now has a menu of 12 high medical value IVD assays, making it the ideal solution for a highly efficient laboratory. "With the addition of these assays to the cobas 4800 menu, more laboratories have access to advanced virology assays that provide reliable results for confident patient management. As the global market leader, we are also pleased to introduce cobas HCV genotype test which accurately identifies HCV genotypes and helps optimize treatment of hepatitis C patients," said Mr Roland Diggelmann, COO, Roche Diagnostics. The assays launched will be followed in the coming months by the cobas HBV Test, which will complete the portfolio of viral load monitoring and genotyping assays for the cobas 4800 System. ]]> <![CDATA[Biocon at No. 13 on the Top 20 Global Biotech Employers for 2015]]> https://biospectrumindia.com/news/95/7482/biocon-at-no-13-on-the-top-20-global-biotech-employers-for-2015.html https://biospectrumindia.com/news/95/7482/biocon-at-no-13-on-the-top-20-global-biotech-employers-for-2015.html Tue, 03 Nov 2015 16:40:56 +0530 The ranking is a result of a global survey conducted by the American Association for the Advancement of Science (AAAS) through its affiliate Science magazine to determine which companies in the biotech and pharmaceutical industry have the best reputations as employers globally. According to the comprehensive 2015 Web-based survey of more than 5,700 respondents on 23 different attributes, Biocon has been recognized for three Key Attributes which are 'Innovative leader in the industry', 'Has loyal employees', and 'Is socially responsible', and has been positioned at No. 13. Dr Kiran Mazumdar-Shaw, CMD, Biocon said, "We are delighted to achieve this global recognition, which is an outcome of our efforts to create an inspiring workplace built on a strong foundation of an innovation-led ecosystem that attracts the best global talent. At Biocon, we have invested in creating a culture that pursues excellence through learning and adopting global best practices. In doing so, we have successfully earned the reputation of being the most preferred biotech employer in Asia." The Top 20 companies with the best reputations as employers were shortlisted from the list of more than 181 global companies. The 2015 survey included a way for respondents to rank the biggest advantages to working in the biopharma industry. Workers voted "innovation" as No. 1, followed by "working with smart colleagues" and "excellent compensation and benefits" as a close No. 2 and No. 3, respectively. Interestingly, workers ranked "having the funding and resources for research projects" as a more distant No. 4. Top Twenty Employers for 2015: 1. Novozymes (Bagsvaerd, Denmark)2. Regeneron Pharmaceuticals, Inc. (Tarrytown, NY, United States)3. Novo Nordisk (Bagsvaerd, Denmark)4. Vertex Pharmaceuticals (Boston, MA, United States)5. Alexion Pharmaceuticals (Cheshire, CT, United States)6. Genentech (South San Francisco, CA, United States)7. Moderna Therapeutics (Cambridge, MA, United States)8. Roche-excluding Genentech (Basel, Switzerland)9. Monsanto Company (Creve Coeur, MO, United States)10. AbbVie (North Chicago, IL, United States)11. Eli Lilly and Company (Indianapolis, IN, United States)12. Celgene Corporation (Summit, NJ, United States)13. Biocon (Bangalore, India)14. Abbott (Abbott Park, IL, United States)15. Boehringer Ingelheim (Ingelheim, Germany)16. Bayer (Leverkusen, Germany)17. Merck KGaA (Darmstadt, Germany)18. Biogen (Cambridge, MA, United States)19. Gilead (Foster City, CA, United States)20. Bristol-Myers Squibb (New York, NY, United States) Methodology To arrive at the final list, The US-based Brighton Consulting Group and Cell Associates first conducted a comprehensive, Web-based survey of 181 companies which had more than 5,700 respondents on 23 different attributes, including 'Corporate Image,' 'Financial Prowess,' 'Leadership and Direction,' 'Work Culture/Environment,' 'Location' and 'Academic and Intellectual Challenge.' Survey respondents from across the globe, including North America, Europe and the Asia Pacific region, were asked to select companies which they considered the 'Best,' 'Average' and 'Worst' employers. A mathematical process was used to determine the attributes with the greatest impact on company/employer reputation. Unique ranking scores were then derived from the ratings given to each company on these attributes. ]]> <![CDATA[FDA nod for Lupin's new generic]]> https://biospectrumindia.com/news/95/7771/fda-nod-for-lupins-new-generic.html https://biospectrumindia.com/news/95/7771/fda-nod-for-lupins-new-generic.html Tue, 03 Nov 2015 14:09:43 +0530 Pharma Major Lupin has announced that it has received final approval for its Blisovi 24 Fe Tablets (Norethindrone Acetate and Ethinyl Estradiol Tablets USP, 1 mg/0.02 mg and Ferrous Fumarate Tablets, 75 mg) from the United States Food and Drug Administration (US FDA) to market a generic version of Warner Chilcott's Loestrin 24 Fe Tablets (Norethindrone Acetate and Ethinyl Estradiol Tablets USP, 1 mg/0.02 mg and Ferrous Fumarate Tablets, 75 mg). Lupin's US subsidiary, Lupin Pharmaceuticals Inc. would commence promoting the product shortly in the US. Lupin's Blisovi 24 Fe Tablets (Norethindrone Acetate and Ethinyl Estradiol Tablets USP, 1 mg/0.02 mg and Ferrous Fumarate Tablets, 75 mg) are the AB rated generic equivalent of Warner Chilcott's Loestrin 24 Fe Tablets (Norethindrone Acetate and Ethinyl Estradiol Tablets USP, 1 mg/0.02 mg and Ferrous Fumarate Tablets, 75 mg). It is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. Loestrin 4 Fe had US sales of $56.8 million (IMS MAT June 2015). ]]> <![CDATA[Shire to buy Dyax Corp]]> https://biospectrumindia.com/news/95/7433/shire-to-buy-dyax-corp.html https://biospectrumindia.com/news/95/7433/shire-to-buy-dyax-corp.html Tue, 03 Nov 2015 14:08:18 +0530 Shire and Dyax Corp. has announced that Shire will acquire Dyax for $37.30 in cash per Dyax share, for aggregate upfront consideration of approximately $5.9 billion. Dyax is a publicly traded, Massachusetts-based biotechnology company primarily focused on the development of plasma kallikrein (pKal) inhibitors for the treatment of HAE, a debilitating and sometimes life-threatening rare genetic disease. Dyax has already successfully developed and commercialized KALBITOR, which is approved for HAE acute treatment in patients 12 years of age and older, and represented an early innovation in HAE treatment. Dyax's most advanced clinical program is DX-2930, a Phase 3-ready, fully humanized monoclonal antibody targeting pKal with proof-of-concept Phase 1B efficacy data. This data demonstrate a > 90 percent reduction in HAE attacks compared to placebo in the 300mg/400mg arms in patients with > 2 attacks in the 3 months prior to study entry. DX-2930 has received Fast Track, Breakthrough Therapy, and Orphan Drug designations by the FDA and has also received Orphan Drug status in the EU. It is expected to enter Phase 3 clinical trials by year-end 2015. If approved for the prevention of Type 1 and Type 2 HAE, DX-2930 could generate estimated annual global sales of up to $2.0 billion. Shire CEO, Dr Flemming Ornskov, said, "This highly complementary transaction aligns with and accelerates our strategy to build a global leading biotechnology company focused on rare diseases and specialty conditions. It adds to our portfolio of best-in-class therapies addressing unmet needs in our core therapeutic areas, expanding and extending our leadership position in HAE. We have closely followed DX-2930's progress in the evolving HAE landscape for some time, and we admire the work of the Dyax team in moving this next-generation therapy forward. Through compelling proof of concept clinical data, this potentially transformative therapy has been shown to be both highly efficacious and convenient, two key product attributes desired by both physicians and patients." Dyax president and CEO Mr Gustav A Christensen said, "We believe this transaction will deliver substantial value to our shareholders and highlights our shared commitment to bringing innovative medicines to patients who suffer from the devastating effects of HAE. Our approved product, KALBITOR, was an important first step to bringing a range of HAE medicines to patients. Shire's expertise and proven rare disease patient identification and management capabilities make it the ideal partner to efficiently bring DX-2930 to HAE patients worldwide. I'm proud of the company that our team has built, and I'm confident that Dyax's important mission and focus on improving the lives of patients will continue as part of the Shire family." The proposed transaction is expected to enhance Shire's long-term top and bottom line growth profile, and is expected to be slightly dilutive to earnings in 2016 and 2017, and accretive in 2018 and beyond, assuming US approval of DX-2930 in 2018. ]]> <![CDATA[Sun Pharma successfully acquires InSite Vision ]]> https://biospectrumindia.com/news/95/5139/sun-pharma-successfully-acquires-insite-vision-.html https://biospectrumindia.com/news/95/5139/sun-pharma-successfully-acquires-insite-vision-.html Tue, 03 Nov 2015 14:05:51 +0530 Sun Pharmaceutical Industries has announced the successful completion of its acquisition of InSite Vision. The acquisition was completed by means of a short-form merger under Delaware law. Post the short-form merger, InSite has become an indirect wholly owned subsidiary of Sun Pharma. As a result of the merger, (i) each issued and outstanding share of InSite common stock (other than shares of InSite common stock owned by the indirect wholly owned subsidiaries of Sun Pharma or InSite (or held in its treasury), any subsidiary of the indirect wholly owned subsidiaries of Sun Pharma or InSite, or by any stockholder of InSite who or which is entitled to and properly demands and perfects appraisal of such shares of InSite common stock pursuant to, and complies in all respects with, the applicable provisions of Delaware law) was converted into the right to receive $0.35 and (ii) each option to acquire shares of InSite common stock that is unexercised and outstanding as of immediately prior to the merger, (a) to the extent not then vested or exercisable, became fully vested and exercisable and (b) was converted into the right to receive a cash payment in an amount equal to the excess, if any, of $0.35 over the exercise price of such option to acquire shares of InSite common stock. As a result of the merger, InSite will no longer have reporting obligations under the Securities Exchange Act of 1934, as amended. Holders of shares of InSite common stock that did not tender their shares into the tender offer will receive by mail written instructions for surrendering their share certificates or transferring their bookentry shares, including a letter of transmittal, and information regarding the exercise of appraisal rights under Delaware law. ]]> <![CDATA[Global allergic rhinitis treatment market to remain stagnant over next decade]]> https://biospectrumindia.com/features/95/4839/global-allergic-rhinitis-treatment-market-to-remain-stagnant-over-next-decade.html https://biospectrumindia.com/features/95/4839/global-allergic-rhinitis-treatment-market-to-remain-stagnant-over-next-decade.html Tue, 03 Nov 2015 13:32:42 +0530 The value of the global treatment market for Allergic Rhinitis (AR) will witness minimal growth from $7.2 billion in 2014 to $7.3 billion by 2024, representing a Compound Annual Growth Rate (CAGR) of 0.1 percent, says research and consulting firm GlobalData. The company's latest report states that the global market will remain stagnant by 2024, primarily due to an increasing push for patients to self-medicate using over-the-counter (OTC) products, hindering growth in the prescription drug space. Dr Claire Gibson, GlobalData's managing analyst, says: "In an attempt to retain a revenue stream from branded generics, companies have sought a successful strategy to convert their AR prescription drugs to OTC status, known as the Rx-to-OTC switch, transferring these products to their respective consumer care units. "Direct-to-consumer advertising, increased co-payments on prescription AR drugs, and stretched healthcare resources, as well as the increasingly competitive cost of OTC-equivalent options, will further drive the growing trend for AR patients to seek treatment independently." The analyst adds that of the seven major pharmaceutical countries of the US, France, Germany, Italy, Spain, the UK and Japan, the US holds the largest AR treatment market share of 38 percent, which will remain the same over the forecast period. The introduction of US Food & Drug Administration (FDA)-approved OTC intranasal corticosteroids (INCS) in the US is set to have a particularly negative impact on the prescription drug treatment rate. Dr Gibson explains: "Second-generation H1 receptor antagonists and INCS are the leading drug classes in terms of market value, with the latter currently capturing almost half the total AR treatment space. However, their share will shrink from 63 percent in 2014 to 48 percent by 2024, due to the launch of novel allergen immunotherapies for treating moderate-to-severe AR over the forecast period. "These immunotherapies will subsequently start dominating the AR therapeutics space, with their sales increasing from 14 percent in 2014 to 26 percent by 2024. Their uptake will account for the majority of the anticipated AR drug market growth, and will offset the dip in sales caused by generic erosion of leading AR treatments, such as Nasonex and Astepro (azelastine hydrochloride), as well as Singulair (montelukast sodium) in Japan." ]]> <![CDATA[BMS to acquire Cardioxyl Pharmaceuticals]]> https://biospectrumindia.com/news/95/7300/bms-to-acquire-cardioxyl-pharmaceuticals.html https://biospectrumindia.com/news/95/7300/bms-to-acquire-cardioxyl-pharmaceuticals.html Tue, 03 Nov 2015 13:29:36 +0530 BMS and Cardioxyl announced that the companies have signed a definitive agreement under which Bristol-Myers Squibb will acquire all of the issued and outstanding capital stock of Cardioxyl, a private biotechnology company focused on the discovery and development of novel therapeutic agents for the treatment of cardiovascular disease. The acquisition will give Bristol-Myers Squibb full rights to Cardioxyl's lead asset CXL-1427, a novel nitroxyl (HNO) donor (prodrug) in Phase 2 clinical development as an intravenous treatment for acute decompensated heart failure (ADHF). The transaction includes upfront and near-term milestone payments of up to $300 million and potential additional consideration of up to $1.775 billion upon the achievement of certain development, regulatory and sales milestones. The transaction, which is expected to be dilutive to 2015 GAAP EPS by approximately $0.12, with minimal dilution to non-GAAP EPS in both 2015 and 2016, has been approved by the boards of directors of both companies. CXL-1427 releases nitroxyl, a molecule that has demonstrated beneficial effects on heart muscle and vascular function. Pre-clinical and early clinical data indicate that CXL-1427 improves how the heart muscle contracts and relaxes without increasing heart rate or the demand for oxygen. Current therapies for ADHF that improve heart muscle function produce an increase in heart rate and/or oxygen consumption, and are associated with an increased risk for ischemia, arrhythmias and increased mortality. "The acquisition of Cardioxyl strengthens Bristol-Myers Squibb's heart failure pipeline with a Phase 2 asset that has the potential to change the course of the disease rather than simply treating the symptoms," said Dr Francis Cuss, EVP & CSO, Bristol-Myers Squibb. "BMS is uniquely positioned, with our understanding of patient needs in the hospital setting and our heritage in cardiovascular diseases, to continue development of CXL-1427 as a potential new therapy to address the clinical and economic burden of heart failure." "We are excited about the breadth of drug development capabilities and cardiovascular expertise that Bristol-Myers Squibb will bring to the nitroxyl donor program," said Dr Christopher A Kroeger, president & CEO, Cardioxyl. "Heart failure is an important and under-served therapeutic area and we believe Bristol-Myers Squibb is the optimal partner to bring new therapeutic options to the patients who need them." Closing of the transaction is subject to customary closing conditions, including clearance under the Hart-Scott-Rodino Antitrust Improvements Act. ]]> <![CDATA[Merck receives breakthrough therapy designation from USFDA for Keytruda ]]> https://biospectrumindia.com/news/95/7299/merck-receives-breakthrough-therapy-designation-from-usfda-for-keytruda-.html https://biospectrumindia.com/news/95/7299/merck-receives-breakthrough-therapy-designation-from-usfda-for-keytruda-.html Tue, 03 Nov 2015 13:28:08 +0530 Merck, known as MSD outside the United States and Canada, announced that the US Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation to KEYTRUDA (pembrolizumab), the company's anti-PD-1 therapy, for the treatment of patients with microsatellite instability high (MSI-H) metastatic colorectal cancer. KEYTRUDA is a humanized monoclonal antibody that works by increasing the ability of the body's immune system to help detect and fight tumor cells. It blocks the interaction between PD-1 and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes which may affect both tumor cells and healthy cells. "We are committed to understanding the full potential of KEYTRUDA to help patients with a broad range of difficult-to-treat cancers," said Dr Roger M Perlmutter, president, Merck Research Laboratories. "The data investigating the use of KEYTRUDA in patients with advanced colorectal cancer whose tumors have substantial evidence of mismatch DNA repair defects have been encouraging, and we appreciate the opportunity that this FDA Breakthrough Therapy Designation provides us to accelerate our effort to bring KEYTRUDA to these patients." The FDA's Breakthrough Therapy Designation is intended to expedite the development and review of a candidate that is planned for use, alone or in combination, to treat a serious or life-threatening disease or condition when preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints. KEYTRUDA was previously granted breakthrough status for advanced melanoma and advanced non-small cell lung cancer (NSCLC). The Breakthrough Therapy Designation in advanced colorectal cancer is based on data from a Phase 2 study evaluating the activity of KEYTRUDA in cancers with microsatellite instability, a well-established feature seen in cells with certain types of DNA repair defects. Findings from the study, led by researchers from Johns Hopkins Kimmel Cancer Center, were presented at the 2015 American Society of Clinical Oncology (ASCO) annual meeting and were published simultaneously in the New England Journal of Medicine. Testing tumors for microsatellite instability can identify patients with defective DNA mismatch repair (MMR) systems. DNA MMR is a process that permits cells to recognize and repair genetic mismatches generated during DNA replication. A defective MMR system allows mismatch mutations to persist. The average tumor has dozens of mutations; however tumors with DNA MMR deficiency may harbor thousands, especially in regions of repetitive DNA known as microsatellites. Tumors that are found to have mutations in select microsatellite sequences, called microsatellite instability (MSI), are considered DNA MMR-deficient. These tumors are referred to as being "MSI high". Overall, DNA MMR-deficiency is present in approximately 15-20 percent in Stage II disease, 10 percent in Stage III disease and approximately 5 percent or less in Stage IV disease. In colorectal cancers, MMR-deficiency is seen in approximately 15-20 percent of non-hereditary colorectal cancers and in most hereditary colorectal cancers associated with Lynch Syndrome. Merck is conducting a Phase 2 registration study (KEYNOTE-164) to evaluate the efficacy and safety of KEYTRUDA based on microsatellite instability status in patients with previously treated advanced colorectal cancers, and is also planning a Phase 3 study (KEYNOTE-177) in a treatment naÃ¯ve patient population. The KEYTRUDA clinical development program includes patients with more than 30 tumor types in more than 160 clinical trials, including more than 80 trials that combine KEYTRUDA with other cancer treatments. ]]> <![CDATA[New blockbuster drugs to push multiple myeloma treatment market value]]> https://biospectrumindia.com/features/95/7090/new-blockbuster-drugs-to-push-multiple-myeloma-treatment-market-value.html https://biospectrumindia.com/features/95/7090/new-blockbuster-drugs-to-push-multiple-myeloma-treatment-market-value.html Mon, 02 Nov 2015 15:34:13 +0530 The global treatment market for multiple myeloma will rise in value from $8.9 billion in 2014 to an estimated $22.4 billion by 2023, representing an impressive Compound Annual Growth Rate (CAGR) of 11.2%, according to research and consulting firm GlobalData. The company's latest report states that this increase, which will occur across the eight major markets of the US, France, Germany, Italy, Spain, UK, Japan, and urban China, will be boosted by increasing therapeutic options, including the introduction of two monoclonal antibodies (mAbs) with blockbuster potential, namely Empliciti and daratumumab, during the forecast period. Dr Dan Roberts, GlobalData's senior analyst covering oncology and hematology, says the patent expiries of a number of key treatments will pave the way for the new mAbs to have a major impact on the multiple myeloma therapeutics space by 2023. He comments: "The patents of the two best-selling drugs in multiple myeloma treatment, namely Revlimid (lenalidomide) and Velcade (bortezomib), will both expire in the US and five European countries during the forecast period. "As a consequence, Celgene will lose its dominance in this therapy area, with its market share anticipated to fall dramatically from 68% in 2014 to a mere 17% by 2023." The analyst adds that Janssen/Genmab and Bristol-Myers Squibb/AbbVie both have very promising pipelines for multiple myeloma, driven primarily by the excitement surrounding their mAbs daratumumab and Empliciti, respectively. Dr Roberts continues: "Based on GlobalData's primary research, it is expected that these agents will prove very popular in the stem cell transplantation-ineligible induction setting, and in patients who have relapsed on several prior therapies. "We believe that Empliciti will be preferred for use in combination with Revlimid/dexamethasone over daratumumab/Revlimid/dexamethasone, due to Empliciti and Revlimid's synergistic actions on the immune system and Empliciti being approved first with this combination, while daratumumab will be approved first as a monotherapy in patients who have stopped responding to Velcade and an IMiD." Both Empliciti and daratumumab are expected to first launch in 2016. Empliciti is forecast to reach blockbuster status by 2018 with peak sales in 2022 at $4.2 billion, while daratumumab is anticipated to achieve peak sales of $3.7 billion in 2023, according to GlobalData. ]]> <![CDATA[Global endoscopy market value to climb to $9.7 bn by 2021]]> https://biospectrumindia.com/features/95/7472/global-endoscopy-market-value-to-climb-to-9-7-bn-by-2021.html https://biospectrumindia.com/features/95/7472/global-endoscopy-market-value-to-climb-to-9-7-bn-by-2021.html Mon, 02 Nov 2015 15:31:41 +0530 The global endoscopy market will rise in value from $5.7 billion in 2014 to just under $9.7 billion by 2021, representing a Compound Annual Growth Rate (CAGR) of 6.9%, according to research and consulting firm GlobalData. The company's latest report states that this growth, which will occur across the 10 major markets of the US, France, Germany, Italy, Spain, UK, Japan, Brazil, China and India, will be driven primarily by increasing adoption of endoscopic surgeries and screening programs, as well as a rising patient population. Wenlu Hu, GlobalData's analyst covering medical devices, says the use of minimally invasive endoscopy techniques for both diagnostic and therapeutic purposes will increase in proportion with the rising prevalence of diseases worldwide. Hu explains: "Endoscopy offers the possibility of accurate visualization of the current state of patients with a variety of diseases, which consequently improves the treatment process. Early disease diagnosis is the key to reducing healthcare expenses, meaning endoscopy techniques play a vital role in treating patients in the most cost-effective manner. "The most promising areas of growth are colonoscopy, gastroscopy, cystoscopy, bronchoscopy, laryngoscopy, and endoscopy visualization systems, where there has been significant focus in terms of pipeline development." GlobalData's report also states that the endoscopy market is highly fragmented and experiences fierce pricing competition, meaning companies require shrewd corporate strategies in order to increase their market shares. Hu continues: "In the US market, Olympus holds the number one spot, with the top five players commanding 80% of the market. Olympus' closest competitor is Karl Storz, which has a particularly strong product portfolio in the endourology space. "The remaining 20% of the US endoscopy market is occupied by the small-to-medium enterprises that are involved in cutting-edge research. One such upcoming company is EndoChoice with its innovative Fuse GI endoscopy system." ]]> <![CDATA[Dr Reddy's launches new OTC product]]> https://biospectrumindia.com/news/95/3860/dr-reddys-launches-new-otc-product.html https://biospectrumindia.com/news/95/3860/dr-reddys-launches-new-otc-product.html Mon, 02 Nov 2015 15:30:33 +0530 Dr. Reddy's has announced the launch of Nise D spray, emphasizing its strategic intent of being a player of substance in the Indian OTC (Over The Counter) space. Nise D spray, offers quick and targeted pain killing. Through this product Dr Reddy's has further expanded its offerings in the therapeutic area of pain relief to consumers. In India, the market for pain relief products is approximately Rs 1,700 crore. Pain relief sprays are growing 20 times faster than creams and gels, indicating a trend ofchanging consumer preferences. The formulation for Nise D Spray comprises 3 key ingredients which get absorbed quicker, penetrate deep to reach the source of pain and reduce inflammation. Nise, as a brand has been providing effective relief to consumers by killing pain over the years. Nise believes in reaching out to consumers at the point of incidence or in a relevant context. Nise was the firstever pain relief partner of the Indian Super League and various marathons in key cities across India. Mr M V Ramana EVP and head branded markets (India and Emerging countries), Dr Reddy's said, "Nise D Spray marks our entry into the new segment and further boosts our OTC portfolio. Nise gel has made a remarkable headway into the market and looking at the market dynamics and consumer requirements, we expect Nise D Spray to have a great momentum and significant market share across regions." Nise D Spray will be available across all leading and neighborhood pharmacy store. It will be available in two convenient pack sizes - pocket pack at Rs 99/- and home pack for Rs 130/-. ]]> <![CDATA[Global Clostridium difficile infections market to soar to $1.5 bn by 2024]]> https://biospectrumindia.com/features/95/7780/global-clostridium-difficile-infections-market-to-soar-to-1-5-bn-by-2024.html https://biospectrumindia.com/features/95/7780/global-clostridium-difficile-infections-market-to-soar-to-1-5-bn-by-2024.html Fri, 30 Oct 2015 12:44:00 +0530 The global therapeutics and prophylactics market for Clostridium difficile infections (CDIs) will expand more than fourfold from $356.3 million in 2014 to over $1.5 billion by 2024, representing an impressive Compound Annual Growth Rate (CAGR) of 15.8%, according to research and consulting firm GlobalData. The company's latest report states that this increase, which will occur across the seven major markets (7MM) of the US, France, Germany, Italy, Spain, the UK and Japan, will be driven by the modest uptake of patent-protected, CDI-specific antibiotics and the arrival of novel non-antibiotic approaches to treat and prevent recurrent CDI. Dr Marc C Hansel, GlobalData's healthcare industry analyst, says that while Merck will lead the CDI treatment landscape during the forecast period, several other competitors, such as Sanofi Pasteur, Rebiotix, and Seres Health could also take a sizeable share of the market by 2024. He comments: "We anticipates that Merck's Dificid will be the antibiotic market leader due to its first-to-market status and uncertainty over whether the current pipeline antibacterials, such as Actelion's cadazolid, Merck's surotomycin, and Summit Therapeutics' SMT19969, will provide improved clinical benefits in terms of higher initial cure rates and lower recurrence rates. "Adjunctive therapies, such as Merck's bezlotoxumab, Seres Therapeutics' SER-109, and Rebiotix's RBX2660, will be primarily prescribed for patients at high risk of recurrence or those with multiple recurrent infections, but uptake could be limited by the high cost of these therapies." The analyst adds that prophylactic vaccines, led by Sanofi Pasteur's ACAM-CDIFF, will also contribute to the increase in CDI treatment market over the forecast period, and projects a modest uptake of vaccines once they are approved in the 7MM. Dr Hansel continues: "Opportunity remains to position a rationally-designed microbiologic as a prophylactic option to prevent infections in high-risk patients, as no current late-stage company is positioning one to be used in this manner. "An early-stage prophylactic pipeline player to watch is Synthetic Biologics' SYN-004, which has tremendous potential, but is still in the early phases of clinical development and remains unproven in a large efficacy trial," the analyst concludes. ]]> <![CDATA[APAC multiple myeloma treatment market value to reach $2.8 bn by 2021]]> https://biospectrumindia.com/features/95/6657/apac-multiple-myeloma-treatment-market-value-to-reach-2-8-bn-by-2021.html https://biospectrumindia.com/features/95/6657/apac-multiple-myeloma-treatment-market-value-to-reach-2-8-bn-by-2021.html Fri, 30 Oct 2015 12:42:45 +0530 The treatment market for multiple myeloma across the Asia-Pacific (APAC) countries of China, India, Japan, and Australia will rise in value from $1.7 billion in 2014 to $2.8 billion by 2021, representing a Compound Annual Growth Rate (CAGR) of 7.4%, according to business intelligence provider GBI Research. The company's latest report states that growth will primarily be driven by the emergence of novel therapeutics that have significantly improved clinical outcomes across all stages of the disease, as well as the lack of generic competition in China, Japan and Australia. Ms Deekshita Allavarapu, analyst for GBI Research, expects the leading brands, Revlimid, Velcade and Thalomid, to continue to perform strongly in the APAC multiple myeloma treatment space, with minimal generic competition at present. She explains: "The only leading brand that faces imminent generic challenge is the proteasome inhibitor Velcade, the patent of which is expected to expire in China, Japan and Australia in 2015, 2018 and 2020, respectively. Generic versions of Velcade are already available in India. "Furthermore, there are now several options in the relapsed or refractory disease setting, which will also contribute to growth in the APAC multiple myeloma therapeutics market by 2021. These drugs include Pomalyst, which was approved in Australia and Japan in 2013, and Farydak, which was approved in Japan earlier this year." Ms Allavarapu continues: "Kyprolis will be launched in the APAC region in the near future, Daratumumab has been trialed in combination with Revlimid and dexamethasone, and elotuzumab has been trialed in combination with Revlimid. "These emerging multiple myeloma therapies are likely to offer alternatives in the relapsed or refractory disease setting, in both the second and third lines of treatment, further boosting APAC market growth." Other promising multiple myeloma pipeline drugs are Zolinza, filanesib and plitidepsin. However, no clinical trial is registered for these treatments in the APAC countries and they are only expected to launch towards the end of forecast period. ]]> <![CDATA[Pfizer, GSK to co-develop PCMM manufacturing units]]> https://biospectrumindia.com/news/95/6912/pfizer-gsk-to-co-develop-pcmm-manufacturing-units.html https://biospectrumindia.com/news/95/6912/pfizer-gsk-to-co-develop-pcmm-manufacturing-units.html Fri, 30 Oct 2015 11:08:58 +0530 Pfizer has announced a multi-year collaboration with GSK on the development of a next-generation equipment design, building upon Pfizer's existing portable, continuous, miniature and modular (PCMM) prototype for oral solid dose (OSD) pharmaceutical development and manufacturing. Pfizer's current PCMM prototype is an autonomous and transportable pod that may be quickly shipped from location to location and readily brought online to create a fully functional module that is compliant with industry-standard good manufacturing practice (GMP) guidelines. Together with GSK, which has notable technical and regulatory experience in continuous processing, Pfizer will conduct coordinated experiments to create the next-generation design of Pfizer's current PCMM prototype. This collaboration expands upon Pfizer's existing collaboration with GEA and G-CON Manufacturing, which resulted in the design of the current prototype unit presently implemented at Pfizer's labs in Groton, Conn. "Pfizer's success in building a first-of-a-kind, transportable, modular prototype for oral solid dose pharmaceutical development and manufacturing holds promise to help transform industry practices, and we invite other organizations to join us in this effort," said Mr Rod MacKenzie, senior vice-president, PharmaTherapeutics Research and Development at Pfizer. "We believe coupling Pfizer's industry-leading development and manufacturing capabilities with GSK's experience and expertise in continuous processing has the potential to lead to a superior technology, thereby allowing us to more quickly and efficiently bring therapies to patients." "GSK is pursuing a strategy to enhance our manufacturing supply chains and drive access to medicines for patients. Continuous manufacturing is a key part of that strategy," said Mr Mark Buswell, vice-president and head of advanced manufacturing technologies at GSK. "This strategic collaboration allows Pfizer and GSK to align on a vision for PCMM-OSD equipment designs and enables us to deploy flexible, agile and reliable manufacturing solutions to benefit patients." Pfizer's PCMM technology is a first-of-a-kind manufacturing system that accelerates the speed of tablet production. The pharmaceutical industry has been trending toward lower-volume products, driven by an increased focus on precision medicine approaches to develop and commercialize new therapies. This creates a need for smaller, more flexible continuous processing technologies. By miniaturizing the equipment, the continuous process can be enclosed in a portable, autonomous space called a POD, which can be transported to any location in the world and quickly assembled. The PCMM technology has the potential to transform the current biopharmaceutical industry standard of using batch processing to manufacture tablets and capsules from powders-an oftentimes complex process that requires large, dedicated manufacturing facilities. The PCMM continuous process takes only minutes from the addition of raw materials to the completion of finished tablets or capsules. ]]> <![CDATA[Glenmark's new generic granted tentative ANDA approval ]]> https://biospectrumindia.com/news/95/8031/glenmarks-new-generic-granted-tentative-anda-approval-.html https://biospectrumindia.com/news/95/8031/glenmarks-new-generic-granted-tentative-anda-approval-.html Fri, 30 Oct 2015 11:06:57 +0530 Glenmark Pharmaceuticals USA (Glenmark) has been granted tentative approval by the United States Food and Drug Administration (US FDA) for its Lacosamide Tablets, 50 mg, 100 mg, 150 mg and 200 mg, the generic version of Vimpat Tablets, 50 mg, 100 mg, 150 mg and 200 mg of UCB. Glenmark will market this product upon receiving final approval of its Lacosamide Tablets, 50 mg, 100 mg, 150 mg and 200 mg ANDA. The patent listed in the Orange Book for Vimpat Tablets, 50 mg, 100 mg, 150 mg and 200 mg is scheduled to expire on March 17, 2022. According to IMS Health sales data for the 12 month period ending September 2015, the Vimpat market achieved annual sales of approximately $691.0 million. Glenmark's current portfolio consists of 102 products authorized for distribution in the US marketplace and 64 ANDA's pending approval with the U.S. FDA. ]]> <![CDATA[APAC medical tourism to touch $20.47 bn by 2019: Report]]> https://biospectrumindia.com/news/95/7026/apac-medical-tourism-to-touch-20-47-bn-by-2019-report.html https://biospectrumindia.com/news/95/7026/apac-medical-tourism-to-touch-20-47-bn-by-2019-report.html Thu, 29 Oct 2015 11:48:00 +0530 According to a new analysis from Frost & Sullivan, Asia-Pacific medical tourism earned revenues of $9.62 billion in 2014 and is estimated to grow at a compound annual growth rate of 16.3 percent to touch $20.47 billion by 2019. According to the report, majority of medical tourists to the region are from Asia, Middle East and Africa driven by quality of medical care, immediate access as well as cost effective treatments drive the choices of location. Additionally, as medical tourists tend to travel with their spouses, relatives or friends, these travelers represent additional revenue generation opportunities for the hospitality and airlines sector. "The medical tourism industry in Asia-Pacific has been experiencing a boom owing to its offer of quality healthcare, ease of access due to availability of travel options and the affordability of treatment compared to western countries," said Ms Rhenu Bhuller, partner, Frost & Sullivan. The industry is becoming more competitive with the emergence of new medical tourism hotspots, more healthcare providers expanding in the area as well as source countries strengthening their local healthcare infrastructure to minimize the outflow of tourists. "Overall, medical tourism revenue growth is expected to be in the double digits till 2019," observed Ms Bhuller. "The traditional markets like Thailand, India and Singapore are expected to grow at a steady pace, whereas Malaysia and South Korea are likely to experience stronger growth albeit from a lower revenue base." ]]> <![CDATA[Sun Pharma recalls allergy drug in the US]]> https://biospectrumindia.com/news/95/6656/sun-pharma-recalls-allergy-drug-in-the-us.html https://biospectrumindia.com/news/95/6656/sun-pharma-recalls-allergy-drug-in-the-us.html Thu, 29 Oct 2015 11:46:26 +0530 As per the information available on the US Food and Drug Administration's (US FDA)website, Ohm Laboratories, a unit of Ranbaxy Laboratories, is recalling 10,85,095 boxes for being "Superpotent Drug: Out Of Specification." Sun Pharma had acquired Ranbaxy in a $4-billion deal last year. The recall was initiated on July 28 this year and has been put under Class-III which the US FDA defines as "a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences." ]]> <![CDATA[OPPI honors AstraZeneca India]]> https://biospectrumindia.com/news/95/6605/oppi-honors-astrazeneca-india.html https://biospectrumindia.com/news/95/6605/oppi-honors-astrazeneca-india.html Thu, 29 Oct 2015 11:45:28 +0530 AstraZeneca (AZ) India has received Dr H R Nanji Memorial OPPI (Organisation of Pharmaceutical Producers of India) Marketing Excellence Awards 2015 for its drug Brilinta (ticagrelor 90 mg), an innovative treatment solution for Acute Coronary Syndrome (ACS). The Award was handed over by Dr V K Subburaj, secretary, Department of Pharmaceuticals. The biopharmaceutical firm received this Award in the "Best New Pharma Product launch" category. Brilinta is said to be one of the leading brands by market share in the oral anti-platelet market and remains committed to continue drive a paradigm shift in the way ACS is managed in India. Dr Bhavesh Kotak, vice-president, medical and regulatory affairs, AstraZeneca India said, "ACS causes 28 per cent of all cardiovascular deaths globally and there is a huge unmet medical need in this area. We are pleased to receive this recognition for our efforts in improving the lives of ACS patients in India. Additionally as a science-led organisation, we trust in the potential of ideas and support the efforts of research scientists such as Prof Vandana B Patravale," in a statement. ]]> <![CDATA[RSSDI endorses FIT recommendations for effective insulin management ]]> https://biospectrumindia.com/news/95/6394/rssdi-endorses-fit-recommendations-for-effective-insulin-management-.html https://biospectrumindia.com/news/95/6394/rssdi-endorses-fit-recommendations-for-effective-insulin-management-.html Wed, 28 Oct 2015 11:59:00 +0530 Research Society for the Study of Diabetes in India (RSSDI), the largest organization of diabetes health care professionals and researchers in Asia has endorsed FIT (Forum for Injection Technique) India recommendations for best practice in insulin injection technique for people living with diabetes through its 6444 life members from 29 Indian States and Union Territories. The initiative is expected to benefit over 2 million diabetes patients with regards to long time insulin and insulin-like therapy adherence, smooth drug delivery and minimisation of adverse side effects. In the past, several studies have cited reasons as to why some patients dread insulin injection usage. According to a study published in Diabet Med, 20 percent of insulin users often or sometimes skipped their injections while 10% restricted their number of daily injections due to needle anxiety, pain or embarrassment. Another study has found that bacterial contamination, local inflammatory changes and injection pain increased in direct proportion to needle re-use, highlighting an increased risk of infection. Prof S V Madhu, professor and head, Dept. of Medicine & Endocrinology, UCMS-GTB Hospital & President, Research Society for Study of Diabetes in India (RSSDI) said, "The number of people with Type 2 diabetes is on the rise in every country, with earlier diagnosis and longer life spans meaning that there is an increasing likelihood that they will need to use injectable therapies to control their condition. Therefore it becomes extremely important that standard insulin techniques and best practices are adopted across the country at par with global standards." FIT India is an autonomous organisation which supports people with diabetes using injectable therapies to achieve the best possible health outcomes that can be influenced by correct injection technique. The development of FIT and the subsequent India recommendations for injection technique have been supported by prominent medical technology firm Becton, Dickinson & Co. (BD India). Dr Rajeev Chawla, senior consultant Diabetologist and Secy, Research Society for Study of Diabetes in India (RSSDI) said, "Poor technique, including the use of an inappropriate needle length, failure to rotate injection sites and the re-use of needles, can lead to insulin being absorbed in an unpredictable manner, potentially leading to complications such as hypoglycaemia, hyperglycaemia and even ketoacidosis in patients with Type 1 diabetes. Injection technique addresses all these factors, and more." As per the FIT recommendations, special emphasis is to be given to counter complications arising out of incorrect usage of injections and usage in special groups like elderly population, pregnant women and people with weak immunity. The recommendations also suggest correct injection technique that can help protect against lipohypertrophy (lump formation), unexplained hypoglycemia (low blood sugar) and blood glucose variation. Estimate suggests out of 67 million diabetes patients living in India, 3 million use injections. Doctors feel that the rate of insulinization is low in India. This is a road block in the optimal management of diabetes because of fear of needles and lifelong dependence on insulin. It is estimated that two thirds (64 percent) of insulin users develop lipohypertrophy at some time in their lives that can result in varied absorption and consequent erratic glycaemic control. Dr Laurence Hirsch, vice president, Global Medical Affairs, Diabetes Care at BD, said, "For patients, the understanding and practice of correct injection technique has the potential to make a real difference to their lives, helping to deliver their insulin more consistently, reduce discomfort and minimise the risk of developing associated complications such as lipohypertrophy.The key is education and our mission is to reach the influencers, educators and healthcare workers who will support and disseminate the new recommendations in their daily practice." Research has shown that that correct injection and infusion technique can have positive impact on the health outcomes of people living with diabetes. As per a study published in Journal of Clinical and Translational Endocrinology (2014), correct injection technique education not only improved blood glucose control in people with diabetes, but also provided greater satisfaction with therapy and lowered the daily consumption of insulin after only three months - a relatively short period of time.The success of insulin injection therapy and the adherence to it depends on several factors such as a smooth insulin initiation process with counselling that alleviates the fear of needles, the insulin regime, length of needle and the method of administration. Shorter needles can provide safety from injecting into muscle, as an insulin injection in the muscle may lead to hypoglycemia. ]]> <![CDATA[DBT & Gates foundation pledge $25 million for Grand Challenges India]]> https://biospectrumindia.com/news/95/1194/dbt-gates-foundation-pledge-25-million-for-grand-challenges-india.html https://biospectrumindia.com/news/95/1194/dbt-gates-foundation-pledge-25-million-for-grand-challenges-india.html Wed, 28 Oct 2015 11:26:17 +0530 The Grand Challenges initiative, launched in 2003 by the Bill & Melinda Gates Foundation seeks to encourage research and development to develop innovative solutions to tackle the myriad health and development challenges afflicting the lives of millions of poor across the globe. Recently the Annual Grand Challenges meeting was held from October 18-21 in Beijing, China. The meeting witnessed the convening of over 800 researchers, scientists, as well as high-level representatives from governments and organizations from across the globe to share proven practices, encourage partnerships and seek solutions to address the health challenges in the world. Grand Challenges India was jointly launched by the Biotechnology Industry Research Assistance Council (BIRAC), Department of Biotechnology (DBT) and the Bill & Melinda Gates Foundation in 2013 to promote scientific and technological advances in health through research and innovation, exclusively for Indian researchers. Under the initiative, the DBT and the Gates Foundation have pledged an investment up to $25 million each, over the period of 5 years. Grand Challenges India seeks to promote and nurture innovations in vaccines, drugs, agricultural products, and interventions related to improving maternal and child health. "We must recognize the need of innovation in developing societies. Encouraging innovation is of principal importance to tackle the problems of open defecation, child morbidity and mortality and malnutrition among mothers and children. The Bill & Melinda Gates Foundation and the Department of Biotechnology, Government of India, have come together to tap the vast potential available in India and drive health innovation in the country." said Mr Trevor Mundel, President of the Global Health Division, Bill & Melinda Gates Foundation. The first two grants under Grand Challenges India focused on, 'Achieving Healthy Growth through Agriculture and Nutrition' and 'Reinvent the Toilet Challenge'. The latest grants under the initiative 'All Children Thriving' were awarded in 2015. Collectively there are 17 researchers and social entrepreneurs from across the country being funded under the partnership. The aim is promote innovation aligned with achieving the SDGs 2, 3 and 6, i.e., end hunger, achieve food security and improved nutrition and promote sustainable agriculture; ensure healthy lives and promote well-being for all at all ages; and ensure availability and sustainable management of water and sanitation for all. Dr K Vijayraghavan, secretary, Department of Biotechnology, Ministry of Science & Technology, Government of India and Chairman, BIRAC stated that "In the past two decades, we have witnessed major advances in science and technology which have transformed the lives of millions in the country. We need to continue to drive innovation and research to meet existing challenges in health care. There is a need to create an enabling environment for research and innovation; where creative confidence and inventiveness is praised and encouraged in order to harness the immense potential available in India. Through partnerships such as the Grand Challenges initiative, we can utilize our vast pool of knowledge and scientific talent to address the health challenges plaguing the country." In India, an estimated 1.27 million children die every year before completing 5 years. 81 percent of under-five child mortality takes place within one year of birth which accounts for nearly 1 million infant deaths and 57 percent of under-five deaths take place within the first one month of life accounting for 730,000 neo-natal deaths every year in the country. Globally, India continues to be the country with the highest number of people (597 million people) practicing open defecation. Dr Renu Swarup, managing director, Biotechnology Industry Research Assistance Council and senior advisor, Department of Biotechnology, Government of India said, "Developing an innovative multi-sectoral approach is imperative to deal with the health challenges that we face today. Fostering innovation is the way to realizing the world's ambition of a better, healthier world and achieving the Sustainable Development Goals. The Bill & Melinda Gates Foundation-DBT-BIRAC partnership aims to fulfil this vision through the Grand Challenges India initiative and encourage Indian researchers from across the country to work towards developing solutions with far-reaching social impact." ]]> <![CDATA[Lupin launches Generic PhosLo in the US]]> https://biospectrumindia.com/news/95/6300/lupin-launches-generic-phoslo-in-the-us.html https://biospectrumindia.com/news/95/6300/lupin-launches-generic-phoslo-in-the-us.html Wed, 28 Oct 2015 11:12:00 +0530 Pharma major Lupin has announced that its US subsidiary, Lupin Pharmaceuticals Inc. (collectively Lupin) has launched its Calcium Acetate Capsules, 667 mg (eq. 169 mg Calcium) having received final approval from the United States Food and Drug Administration (FDA). Lupin's Calcium Acetate Capsules, 667 mg (eq. 169 mg Calcium) are the AB rated generic equivalent of Fresenius Medical Care North America's (Fresenius) PhosLo Gelcaps 667 mg (eq. 169 mg Calcium) and are indicated for the control of hyperphosphatemia in end stage renal failure. PhosLo Gelcaps had annual US sales of $54.5 million (IMS MAT March, 2015). ]]> <![CDATA[Lupin joins hands with Boehringer Ingelheim]]> https://biospectrumindia.com/news/95/6298/lupin-joins-hands-with-boehringer-ingelheim.html https://biospectrumindia.com/news/95/6298/lupin-joins-hands-with-boehringer-ingelheim.html Wed, 28 Oct 2015 11:11:18 +0530 Pharma major Lupin and Boehringer Ingelheim has announced a joint strategic alliance for co-marketing linagliptin, a novel Dipeptidylpeptidase-4 (DPP-4) inhibitor in India. Boehringer Ingelheim has a strong presence in the DPP-4 Inhibitors market in India which is growing at 27 percent (IMS MAT August 2015). According to the agreement, Lupin will market and sell linagliptin under a separate brand name Ondero(monotherapy) and Ondero MetTM (fixed-dose combination with metformin) which will be promoted by Lupin's 400 strong dedicated Diabetes specialty field force. Boehringer Ingelheim will continue to sell its linagliptin under the brand names Trajenta(monotherapy) and TrajentaDuo(fixed-dose combination with metformin) through their existing sales force and network. Ondero tablets (monotherapy) are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus. Ondero MetTM tablets (fixed-dose combination therapy) are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus when treatment with both linagliptin and metformin is appropriate. Announcing the launch, Mr Shakti Chakraborty, group president, India region formulations, Lupin said, "I believe our entry into the high growth DPP-4 Inhibitor market with the launch of Ondero and Ondero MetTM will not only strengthen our Diabetes portfolio but also help us consolidate our position as a market leader and the fastest growing player in the TOP 5 in the Anti-Diabetes segment." About the agreement Mr Sharad Tyagi, MD, Boehringer Ingelheim India said, "We are pleased to partner with Lupin for the sales and promotion of linagliptin as Lupin has a strong play in the Anti-Diabetes segment with a robust product portfolio. The partnership is aligned with our commitment towards addressing challenges in treatment of chronic ailments like diabetes by providing broader access to innovative medicines. It is an ideal partnership where Boehringer Ingelheim brings the research and scientific excellence for linagliptin, and Lupin their marketing excellence and brand equity amongst key clinician categories to drive and facilitate product access. Boehringer Ingelheim India will continue to introduce innovative products to address the unmet patients' needs amidst the growing Indian diabetes epidemic." ]]> <![CDATA[Medtronic receives CE Mark for New Single-Chamber ICDs ]]> https://biospectrumindia.com/news/95/6325/medtronic-receives-ce-mark-for-new-single-chamber-icds-.html https://biospectrumindia.com/news/95/6325/medtronic-receives-ce-mark-for-new-single-chamber-icds-.html Wed, 28 Oct 2015 11:10:38 +0530 Medtronic has announced it has received CE (ConformitÃ© EuropÃ©enne) Mark for the Visia AF and Visia AF MRI SureScan single-chamber implantable cardioverter defibrillators (ICDs), which can detect and monitor new onset, asymptomatic, and previously undiagnosed atrial fibrillation (AF). The Visia AF devices include a proprietary algorithm that accurately detects AF episodes, captures AF burden frequency and duration1, and alerts the physician from the patient's home. Built on the proven performance of the Medtronic Evera family of ICDs, the Visia AF ICDs also feature a contoured shape with thin, smooth edges that increases patient comfort by reducing skin pressure by 30 percent. The devices include the same industry-leading battery longevity (up to 11 years) compared to previous devices. And when paired with the Sprint Quattro Secure MRI SureScan DF4 leads - part of the only ICD lead family with more than 10 years of proven performance with active monitoring - the Visia AF MRI SureScan device allows patients to undergo full-body MRI scans. The Visia AF ICDs include SmartShock 2.0, an exclusive shock reduction algorithm that enables the device to better differentiate between dangerous and harmless heart rhythms. While the majority of shocks delivered are necessary to treat potentially fatal arrhythmias, studies estimate that approximately 20 percent of patients with implantable defibrillators may experience inappropriate shocks in response to a benign arrhythmia or electrical noise sensed by the device. SmartShock technology helps to eliminate these inappropriate shocks, and delivers a 98 percent inappropriate shock-free rate at one year. "Medtronic is committed to continuing to develop a wide range of technologies to help patients with AF. With devices like the Visia AF ICDs and the Reveal LINQ Insertable Cardiac Monitor, which detects and monitors abnormal heart rhythms for up to three years, we aim to increase AF detection and enable physicians to manage a patient's risk for strokes and heart failure," said Dr Marshall Stanton, vice-president and general manager of the Tachycardia business, which is part of the Cardiac Rhythm and Heart Failure division at Medtronic. ]]> <![CDATA[IIL unveils India's largest animal health formulations plant]]> https://biospectrumindia.com/news/95/6203/iil-unveils-indias-largest-animal-health-formulations-plant.html https://biospectrumindia.com/news/95/6203/iil-unveils-indias-largest-animal-health-formulations-plant.html Tue, 27 Oct 2015 15:21:20 +0530 Indian Immunologicals (IIL), a leading biologicals company in India, has opened a new manufacturing facility at Karkapatla, Ranga Reddy District, Telangana. This unit at Phase III of Genome Valley, Karkapatla is IIL's 2nd manufacturing unit in Hyderabad. Spread across on an area of 47 acres area, the plant will significantly expand IIL's manufacturing capabilities. The new facility has been established to manufacture vaccines against infectious diseases of human & animal health formulations catering to domestic as well as international markets. IIL had developed this facility considering the growing demand for the next 10 years for human vaccines and animal health formulations. Human vaccine facility has been established to meet all WHO pre-qualification standards. The first-phase of human vaccine facility has the capacity to produce 8 million doses of human rabies vaccine. The animal health formulation facility is equipped to produce an estimated capacity of 300 million tablets, 100 million bolus, and 20 million vials of injectables. The plant is equipped with cutting-edge German technology and has fully-automated systems consisting of automated granulation, compression lines which have the least possible human intervention. This will become India's largest facility for producing animal health formulations. The facility currently equipped to manufacture Rabies vaccine for humans and produces new animal health formulations for bovines, sheep and pets. The unit will provide direct employment to 150 and indirect employment to 300 people. Commenting on this, Dr K Anand Kumar, deputy managing director, Indian Immunologicals, said "The facility will strengthen IIL's position in the industry and will immensely increase our manufacturing capabilities. We are expecting this plant to play a key role in manufacturing top quality vaccines with the most recent German technology. We will strive to maintain our industry leadership in providing the vaccines in the most affordable prices without compromising on the quality." With the new addition, IIL has 5 manufacturing facilities at various locations - Ooty - Anti rabies production unit; Rajkot Gujarat - Cattle feed Unit; Hyderabad, Gachibowli - Biologicals Unit; New Zealand - Overseas Serum manufacturing unit. IIL currently employs around 1300 people. ]]> <![CDATA[Dr Arjun Kalyanpur awarded 'Healthcare Entrepreneur of the Year']]> https://biospectrumindia.com/news/95/6187/dr-arjun-kalyanpur-awarded-healthcare-entrepreneur-of-the-year.html https://biospectrumindia.com/news/95/6187/dr-arjun-kalyanpur-awarded-healthcare-entrepreneur-of-the-year.html Tue, 27 Oct 2015 14:30:35 +0530 Over the years, Frost & Sullivan's Healthcare Practice has recognized distinguished companies and individuals for their significant achievements and seamless contribution to the country's healthcare industry. The awards banquet, attended by the prominent figures in the healthcare industry celebrated the success of the winning enterprises. Awarded for their growth strategies, due diligence in development and innovation, showcasing best practices adoption and host of other critical factors, the 25 award recipients at the 7th Annual Healthcare Excellence Awards represented the best-in-class of the healthcare business. On the occasion, Mr Sandeep Sinha, VP, Healthcare Practice, South-Asia and Middle-East, Frost & Sullivan said, "The award recipients of this year's Healthcare Excellence Awards represent a mix of established enterprises and innovative start-ups, who with their capability to revolutionize the healthcare industry, are expected to bring in groundbreaking innovations and novel practices in India's healthcare system. Frost & Sullivan is proud to recognize their efforts and encourage them in their future endeavor." This year, the awards were presented across four major award categories: Pharmaceuticals and Biotechnology, Healthcare Delivery Services, Medical Technologies, and Research-based Awards. Following a rigorous process of selection, the awards jury comprising of eminent industry experts, key opinion leaders, and visionary innovators, rated nominees across eight to 10 parameters, backed by the research data from Frost & Sullivan and their market knowledge and domain expertise. Besides these categories, there were two Special Awards conferred by Frost & Sullivan to exemplary individuals who have contributed significantly to the healthcare industry for its advancement and furtherance. This year the 'Healthcare Entrepreneur of the Year' award was given to Dr Arjun Kalyanpur, MD, CEO and chief radiologist/pusher, Teleradiology Solutions. ]]> <![CDATA[Voisin Consulting Life Sciences acquires B&H Consulting Services]]> https://biospectrumindia.com/news/95/6070/voisin-consulting-life-sciences-acquires-bh-consulting-services.html https://biospectrumindia.com/news/95/6070/voisin-consulting-life-sciences-acquires-bh-consulting-services.html Tue, 27 Oct 2015 12:29:17 +0530 Voisin Consulting Life Sciences (VCLS), the global healthcare product development consultancy, and B&H Consulting Services (B&H), an experienced regulatory firm helping pharma and biotech companies facilitate interactions with FDA and navigate the regulatory process, has announced that they are joining forces. The transaction forms one of the largest independent consulting groups delivering high-end regulatory services to support the interactions with the US Food and Drug Administration, the European Medicines Agency, and other global health authorities. VCLS and B&H now have US offices in Cambridge, MA; Somerville, NJ; and San Francisco, CA; in addition to Paris and Rennes, France; London, UK; Lausanne, Switzerland; Bangalore, India; and Singapore. "The demand for U.S. regulatory strategy and operations is very high, which made us accelerate the growth of our existing US teams. Ms Helen Ribbans, founder and president of B&H, and her team possess outstanding expertise, credibility in the industry, and strategic vision that make them the ideal addition to the VCLS family," said VCLS founder and CEO Dr Emmanuelle M Voisin. Founded in 1988 and based in Somerville, NJ, B&H provides strategic regulatory advice to pharma and biotech companies, and supports healthcare innovators in their interactions with US FDA. B&H also delivers in-depth Chemistry, Manufacturing and Controls expertise, as well as strategic and operational support for all regulatory submissions including electronic publishing services. "We are excited by the opportunity to expand the depth and breadth of services that we can offer to our clients as they seek to meet the regulatory requirements of the global healthcare market," said Ms Helen M Ribbans, B&H founder and president. "Joining forces with the VCLS group provides our clients with tremendous experience across all therapeutic areas, and the global footprint that they need to accelerate their results," said Ms Stephanie M Pierson, who was named CEO of B&H as part of this transaction. Ms Pierson previously was vice-president of B&H. The combined team now includes more than 100 regulatory science professionals located across the United States, Europe, and South-East Asia. B&H will continue to operate under its current name, management team and structure, at its Somerville, NJ, headquarters. Constantin Associates LLP, Kahn Partners LLP and Namaskar Corporate Finance acted as advisors to VCLS. Strategic Exit Advisors and Norris McLaughlin & Marcus, PA acted as advisors to B&H. ]]> <![CDATA[CSIR launches affordable plant based drug for diabetes]]> https://biospectrumindia.com/news/95/3871/csir-launches-affordable-plant-based-drug-for-diabetes.html https://biospectrumindia.com/news/95/3871/csir-launches-affordable-plant-based-drug-for-diabetes.html Tue, 27 Oct 2015 11:50:00 +0530 The Council for Scientific and Industrial Research on October 25, 2015 launched the scientifically validated anti-diabetes herbal drug, named 'BGR-34', which is combination of natural extracts from plants, the drug is based on Ayurveda and has no side effects. The drug has been jointly developed by two CSIR laboratories, National Botanical Research Institute (NBRI) and Central Institute for Medicinal and Aromatic Plant (CIMAP) for management of type-II diabetes mellitus. While the formulation was launched earlier by Mr Hamid Ansari, vice president of India in February, 2014, the product has been launched commercially now. Manufactured by New Delhi based Aimil Pharamaceuticals, it will be available in market shortly, will be available in the form of tablets priced at Rs 500 for 100 tablets, which means approximately Rs 5 per tablet. According to NBRI, the drug has been tested on animals and scientific study has found it safe and effective, with clinical trials showing 67 percent success. The drug boosts immune system, works as antioxidant and checks free radicals. The drug will help maintain normal blood glucose levels, reduce chances of complications due to persistent high blood glucose levels and impart a good quality life to patients with high blood sugar levels. ]]> <![CDATA[Ranbaxy CEO to demit office by October end]]> https://biospectrumindia.com/news/95/7448/ranbaxy-ceo-to-demit-office-by-october-end.html https://biospectrumindia.com/news/95/7448/ranbaxy-ceo-to-demit-office-by-october-end.html Mon, 26 Oct 2015 13:54:50 +0530 Mr Arun Sawhney has held the top position at the Ranbaxy for last seven years. During his tenure, the company went through a lot of tribulations ranging from tough regulatory actions mostly in the US to the acquisitions by other pharma companies. Mr Sawhney who has turned 60, joined Ranbaxy in 2008. It was the same time when the Japanese major Daiichi-Sankyo had acquired the firm. He had then taken over as the head of the API (active pharmaceutical ingredient) business and global manufacturing and supply chain. He is credited with managing the Ranbaxy through its deepest crisis like a fine of $500 million. He is also known for his management skills that include the successes such as approval of blockbuster opportunities like Lipitor generic in the US. ]]> <![CDATA[Reconstruction of health systems should remain top priority in Nepal: WHO]]> https://biospectrumindia.com/news/95/4838/reconstruction-of-health-systems-should-remain-top-priority-in-nepal-who.html https://biospectrumindia.com/news/95/4838/reconstruction-of-health-systems-should-remain-top-priority-in-nepal-who.html Mon, 26 Oct 2015 13:15:48 +0530 Six months since the devastating earthquake on 25 April, Nepal has come a long way in restoring essential health services in the most affected 14 districts, filling healthcare gaps and mitigating health-related consequences of the disaster. "However, challenges continue," said Dr Poonam Singh, regional director, WHO South-East Asia Region. "The approaching winter and the ongoing need for trauma management, rehabilitation and mental health services to the affected population highlights the need for continued efforts for reestablishing health services at the earliest." The Ministry of Health and Population, with support from WHO and other health partners, is training primary level health workers across the districts to identify and treat acute malnutrition. Health workers are also being trained to screen and refer patients suffering from mental illnesses. Intermediate injury rehabilitation centers for injured patients called "Step Down facilities" are being established, with technical support from WHO, by partners such as IOM in Sindupalchowk district. These facilities provide intensive rehabilitation before the injured patients go back to their places of origin. The 40 Medical Camp Kits deployed at the onset of the rainy season have helped restore primary health services at the damaged health facilities. The reproductive health camps have been providing ante and post-natal check-ups, safe delivery, family planning and essential drugs. "An immunization campaign in the 14 districts was implemented to maintain high immunity against vaccine preventable diseases," said Dr Poonam. She continued, "Moving forward, it is important that all partners together keep sight of the urgency with which health care gaps must be filled. For those still suffering as a result of the quake, that urgency remains as pressing as it did on 25 April." ]]> <![CDATA[Focus on research & innovation: S&T minister to pharma industry]]> https://biospectrumindia.com/news/95/4735/focus-on-research-innovation-st-minister-to-pharma-industry.html https://biospectrumindia.com/news/95/4735/focus-on-research-innovation-st-minister-to-pharma-industry.html Mon, 26 Oct 2015 12:56:34 +0530 Dr Harsh Vardhan while speaking after presenting the Business Excellence Awards at the India Pharma expo in New Delhi on October 25, 2015 mentioned that it is very important that the Indian pharma industry to focus on research and development to create innovative climate. "The Indian pharmaceutical industry must pursue serious scientific research for providing quality and cost effective medicines to people. Narendra Modi government wants to put the science to use and has called upon the pharmaceutical manufactures to take up challenging researches," said Dr Vardhan adding that in his ministry under the aegis of Department of Scientific and Industrial Research (DSIR) and Department of Biotechnology (DBT), researches are going on in the pharmaceutical sector to benefit the people. The 4th edition of Indian Pharma Expo 2015, was organized by UBM Medica India on 24-25 October 2015, at Pragati Maidan, New Delhi. Indian Pharma Expo 2015 provided an opportunity for the participating companies to display their products and services to the gamut of visitors, globally from pharma and healthcare industries. The two day expo brought together eminent personalities from various sectors of pharma, non-pharma and healthcare industries. As per the organizers, IPE-2015 served as a one stop juncture to all those who are planning to expand their business through various channels of franchise and distribution; as well as wholesalers and hospital purchase personnel who seek to buy bulk products on concessional rates. ]]> <![CDATA[Lupin appoints new president for APAC business]]> https://biospectrumindia.com/news/95/4550/lupin-appoints-new-president-for-apac-business.html https://biospectrumindia.com/news/95/4550/lupin-appoints-new-president-for-apac-business.html Mon, 26 Oct 2015 12:30:00 +0530 Lupin has announced the appointment of Dr Fabrice Egros as president, Asia Pacific and Japan. He will be based in Tokyo, Japan. Dr Fabrice has over 25 years of experience within the global pharmaceutical industry, having worked in leadership roles encompassing P&L management for new markets, mergers & acquisitions, marketing & commercial, global strategy and business development as well as global clinical development, regulatory and manufacturing. He will be responsible for Lupin's growth and development across key markets such as Japan, Australia, the Philippines, South East Asia and new markets in the rest of the ASEAN region. Prior to joining Lupin, Dr Fabrice was with NovaMedica where he was the Deputy CEO/ COO and instrumental in setting up an integrated new pharmaceutical business. Before NovaMedica, he has worked with global majors such as UCB, Sanofi and Parke Davis in various global and regional capacities. Dr Fabrice holds a Degree in Pharmacy, a MS in clinical pharmacology and a Doctorate in Pharmaceutical Sciences from the University of Paris (School of Medicine and Pharmacy) as well as a MBA from Schiller University. He has also completed Advanced Management Program from Harvard University. Commenting on the appointment, Mr Nilesh Gupta, managing director, Lupin, "We are delighted to have Fabrice join the Lupin family. His deep knowledge of the Asia-Pacific markets will be invaluable as we consolidate and grow our business in the region. This region is the third largest revenue contributor for us globally and I believe that Fabrice's experience will help Lupin achieve its growth plans for the Asia Pacific region, and help us scale the business to new heights." ]]> <![CDATA[Glenmark partners with Poland based Celon]]> https://biospectrumindia.com/news/95/4363/glenmark-partners-with-poland-based-celon.html https://biospectrumindia.com/news/95/4363/glenmark-partners-with-poland-based-celon.html Mon, 26 Oct 2015 10:21:34 +0530 Glenmark Pharmaceuticals Europe (Glenmark) has announced that it has entered into a strategic development and licensing agreement with Celon Pharma (Celon). The deal is to develop and market a generic version of GlaxoSmithKline's Seretide Accuhaler product - Fluticasone / Salmeterol dry powder Inhaler in Europe upon commercialization. As per the terms of the agreement; Glenmark has obtained Semi-exclusive marketing and distribution rights of the product across 15 European countries including Great Britain, Germany, Belgium, the Netherlands, Italy, Sweden, Norway and Romania among others. Celon on the other hand, shall receive an upfront payment; followed by certain milestone payments during various stages of the product's development from Glenmark; including Royalties on sales. The distribution agreement was concluded for a period of 10 years, with an option of a two-year extension. "The deal reinforces Glenmark's growing capabilities in the respiratory segment and is a significant step forward towards building a strong respiratory franchise in Europe. We are pleased to collaborate with Celon given their established track record with this inhaler product in Europe," said Mr Glenn Saldanha, chairman and MD, Glenmark Pharmaceuticals. Mr Maciej Wieczorek, CEO of Celon Pharma said, "For many years we have invested heavily in developing technologies for inhalation drugs, and this agreement is yet another proof that the direction we have chosen is correct. The common experiences of both companies in the area of manufacturing, commercialisation and distribution of inhaled drugs will translate into greater availability of combination therapy in a DPI inhaler in many European countries." The Fluticasone / Salmeterol dry powder Inhaler is a combination product for the treatment of chronic obstructive pulmonary disease (COPD). Seretide marketed by GlaxoSmithKline is among the top 3 pharmaceutical brands in Europe with sales of $2.24 billion as per IMS. ]]> <![CDATA[Novartis broadens immuno-oncology pipeline ]]> https://biospectrumindia.com/news/95/6826/novartis-broadens-immuno-oncology-pipeline-.html https://biospectrumindia.com/news/95/6826/novartis-broadens-immuno-oncology-pipeline-.html Mon, 26 Oct 2015 10:03:05 +0530 Novartis has announced that it is broadening its portfolio of cancer immunotherapies with the acquisition of Admune Therapeutics and licensing agreements with Palobiofarma and XOMA Corporation. With four candidates currently in clinical trials and five more agents expected to enter the clinic by the end of 2016, Novartis has rapidly built a robust portfolio of programs focused on stimulating the body's immune system to combat cancers that includes novel checkpoint inhibitors, chimeric antigen receptor T-cell (CART) technology, myeloid cell targeting agents, and STING agonists. Currently Novartis' myeloid cell targeting program (MCS-110) and checkpoint inhibitors targeting PD-1 (PDR001), LAG-3 (LAG525), are in phase 1 clinical trials. The CART program (CTL019) is in phase 2 clinical trials. The anti-TIM-3 program (MGB453) is expected to enter the clinic by the end of 2015 and a STING agonist (MIW815), through collaboration with Aduro Biotech, and GITR agonist are progressing toward first-in-human clinical trials in 2016. The acquisition of Admune adds an IL-15 agonist program currently in phase I clinical trials for metastatic cancer. The licensing agreement with Palobiofarma gives Novartis development and commercialization rights to PBF-509, an adenosine receptor antagonist currently in phase I clinical trials for non-small cell lung cancer. The agreement with XOMA gives Novartis development and commercialization rights to XOMA's TGF-beta antibody programs. All three programs will be explored as monotherapies and in combination with therapies in Novartis' immuno-oncology and targeted therapy portfolios. "The first wave of immuno-oncology therapies has demonstrated the impact this approach can have in treating certain types of tumors. To realize its full potential requires exploration of the complex system of biological pathways in the tumor microenvironment with agents that can stimulate the immune system to attack a wider variety of tumors," said Mr Mark Fishman, president of the Novartis Institutes for BioMedical Research. In pre-clinical studies, IL-15 therapies have been shown to activate CD8+, CD4+ memory T cells and Natural Killer (NK) cells that play a critical role in stimulating the immune system. Adenosine and TGFÃŸ both drive immune suppression in the tumor microenvironment, which allows cancer cells to escape immune surveillance, making inhibition of these two pathways an attractive next-generation immuno-oncology approach. ]]> <![CDATA['Global BioPharma Cold Chain Packaging Market to grow steadily']]> https://biospectrumindia.com/news/95/4155/global-biopharma-cold-chain-packaging-market-to-grow-steadily.html https://biospectrumindia.com/news/95/4155/global-biopharma-cold-chain-packaging-market-to-grow-steadily.html Fri, 23 Oct 2015 10:00:00 +0530 The global biopharmaceutical cold chain packaging market to grow at a CAGR (Compound Annual Growth Rate) of 4.14 percent over the period 2014-2019, says market research firm, Research and Markets. The report, Global Biopharmaceutical Cold Chain Packaging Market 2015-2019 covered Americas, EMEA, and APAC; it also covered the landscape of the global biopharma cold chain packaging market and its growth prospects in the coming years. Outsourcing of pharmaceutical packaging is allowing pharmaceutical companies to reduce inventory and storage costs, and manufacturing time. As a result, more vendors are looking to opt for single-use disposable products to focus on the development of enhanced biopharmaceuticals. According to the report, the implementation of strict regulations on biopharma product packaging by government authorities to drive the market in the forecast period. Further, the report states that factors such as inefficient product labeling processes and complexities in procurement and supply chain processes make it difficult for labeling companies to collect accurate data from sources such as manufacturers and distributors. The Key vendors in the area include Amcor, CCL Industries, Clondalkin Group, Gerresheimer etc. ]]> <![CDATA[Global peripheral artery disease treatment market to peak at $984 mn in 2020]]> https://biospectrumindia.com/features/95/7644/global-peripheral-artery-disease-treatment-market-to-peak-at-984-mn-in-2020.html https://biospectrumindia.com/features/95/7644/global-peripheral-artery-disease-treatment-market-to-peak-at-984-mn-in-2020.html Thu, 22 Oct 2015 10:33:00 +0530 The global treatment market for peripheral artery disease (PAD) will expand in value from approximately $543.4 million in 2014 to a peak of $983.6 million in 2020, before falling to $816.3 million by 2024 due to the generic erosion of Brilinta and Xarelto, according to research and consulting firm GlobalData. The company's latest report states that the initial dramatic increase in the value of the overall global PAD therapeutics space, which covers the eight major markets (8MM) of the US, France, Germany, Italy, Spain, UK, Japan, and urban China, will be partly attributable to the launch of several highly promising PAD drugs currently in late-stage pipeline development. Mr Shaan Thakerar, GlobalData's senior analyst covering cardiovascular and metabolic disorders, says three novel antithrombotic pharmacological agents, namely Merck & Co's Zontivity (vorapaxar), AstraZeneca's Brilinta (ticagrelor), and Bayer and Janssen's Xarelto (rivaroxaban), all have the capacity to reform the antiplatelet and anticoagulatory PAD treatment landscape. Mr Thakerar comments: "The antithrombotic agents Xarelto, Zontivity, and Brilinta will bring new drug targets and novel mechanisms of action to the arsenal of long-term blood-thinning treatment strategies. "The unveiling of Xarelto into the anticoagulant therapeutics space for PAD will mark the biggest step forward in the anticoagulant market since warfarin, but will come without the liabilities of its first-generation predecessor." The analyst adds that Brilinta, a first-in-class nonthienopyridine, will eventually displace clopidogrel, a second-generation thienopyridine, in the PAD treatment paradigm by 2024. However, while the antithrombotic space is brimming with competition, GlobalData anticipates that the global antiplatelet and anticoagulant markets in PAD will become increasingly genericized, progressively more saturated, and challenging to penetrate. Mr Thakerar continues: "Current pipeline agents, such as Brilinta and Xarelto, will eventually lose market exclusivity and patent protection, and these drugs will ultimately relinquish their stake in the PAD marketplace to cheaper, generic copycats in most of the 8MM. "During the forecast period, growth in the PAD therapy market will also be hindered by the existence of cheap and established generic drugs, including aspirin, clopidogrel, and warfarin, as well as limited physician uptake of Brilinta, Zontivity, and Xarelto due to the heightened risk of bleeding associated with these treatments." GlobalData forecasts that Xarelto, Brilinta, and Zontivity will generate global peak-year PAD sales of approximately $168.4 million in 2021, $247.1 million in 2020, and $185.7 million in 2018, respectively. ]]> <![CDATA[Pfizer's Leukemia drug gets US 'breakthrough' status ]]> https://biospectrumindia.com/news/95/7642/pfizers-leukemia-drug-gets-us-breakthrough-status-.html https://biospectrumindia.com/news/95/7642/pfizers-leukemia-drug-gets-us-breakthrough-status-.html Thu, 22 Oct 2015 09:31:00 +0530 Pfizer has announced that investigational antibody-drug conjugate (ADC) inotuzumab ozogamicin received Breakthrough Therapy designation from the U.S. Food and Drug Administration (FDA) for acute lymphoblastic leukemia (ALL). The Breakthrough Therapy designation was based on the results of the Phase 3 INO-VATE ALL trial, which enrolled 326 adult patients with relapsed or refractory CD22-positive ALL and compared inotuzumab ozogamicin to standard of care chemotherapy. Topline results from the trial were announced in April 2015 and also presented at the 20th Congress of the European Hematology Association (EHA). "Inotuzumab ozogamicin is the third Pfizer oncology medicine to be granted Breakthrough Therapy designation by the FDA, underscoring our commitment to innovative research and development that addresses significant unmet needs. Breakthrough Therapy designation will allow us to work more closely with the FDA to bring this important therapy to patients as rapidly as possible," said Dr Mace Rothenberg, senior vice-president of Clinical Development and Medical Affairs and chief medical officer for Pfizer Oncology. He added, "Advancing therapies for patients with adult acute lymphoblastic leukemia is crucial as only 10 percent of adults with ALL who relapse after first-line therapy survive five years or more with current treatment options." Enacted as part of the 2012 FDA Safety and Innovation Act (FDASIA), Breakthrough Therapy designation is intended to expedite the development and review of a potential new medicine if it is "intended to treat a serious or life-threatening disease and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies." The Breakthrough Therapy designation is distinct from the FDA's other mechanisms to expedite drug development and review. ]]> <![CDATA[Allergan completes AqueSys acquisition]]> https://biospectrumindia.com/news/95/7091/allergan-completes-aquesys-acquisition.html https://biospectrumindia.com/news/95/7091/allergan-completes-aquesys-acquisition.html Wed, 21 Oct 2015 12:42:54 +0530 Allergan has announced that it has successfully completed the acquisition of AqueSys. Allergan acquired AqueSys in an all-cash transaction, including a $300 million up-front payment and potential regulatory approval and commercialization milestone payments related to AqueSys' lead development product, XEN45. The AqueSys acquisition adds XEN45, a soft shunt used in minimally invasive glaucoma surgeries (MIGs). XEN45 is implanted by ophthalmologists in the anterior chamber of the eye through a minimally invasive procedure with a single-use, pre-loaded injector. The proprietary XEN45 technology facilitates aqueous fluid flow to lower IOP while protecting against the potential for hypotony (IOP that is too low) that is associated with current subconjunctival procedures. "The acquisition of AqueSys and XEN45 is highly complementary to our leadership position in eye care and underscores our commitment to develop and commercialize treatments that advance care and add value for ophthalmologists and their patients," said Mr Brent Saunders, CEO and president of Allergan. He added, "The treatment of glaucoma is increasingly shifting to dropless therapies given the challenges of patient compliance. The XEN45 device provides a minimally invasive approach to lowering IOP for physicians and their patients seeking new ways to treat glaucoma that go beyond conventional eye drop treatments." XEN45 has received a CE mark in the European Union where it is indicated for the reduction of intraocular pressure in patients with primary open angle glaucoma where previous medical treatments have failed. The CE mark allows treatment in conjunction with a cataract procedure or as a standalone procedure. XEN45 is also approved for use in Turkey, Canada and Switzerland. In the United States, XEN45 is in late-stage development, with the final U.S. Investigational Device Exemption (IDE) clinical trial fully enrolled as of the second quarter of 2015. Final approval by the U.S. Food and Drug Administration is expected by late 2016 or early 2017 via the 510K device pathway. XEN45 adds to Allergan's strong late-stage eye care pipeline, with therapies in development to treat glaucoma, dry eye disease, age-related macular degeneration (AMD) and diabetic macular edema (DME). ]]> <![CDATA[AZ, Peregrine expand ongoing Immuno-Oncology collaboration ]]> https://biospectrumindia.com/news/95/6888/az-peregrine-expand-ongoing-immuno-oncology-collaboration-.html https://biospectrumindia.com/news/95/6888/az-peregrine-expand-ongoing-immuno-oncology-collaboration-.html Wed, 21 Oct 2015 12:42:25 +0530 Peregrine Pharmaceuticals has announced that it has expanded its ongoing cancer immunotherapy clinical collaboration with AstraZeneca to include a second, later-stage trial. The companies will now also evaluate the immunotherapy combination of Peregrine's phosphatidylserine (PS)-targeted immune-activator, bavituximab, and AstraZeneca's anti-PD-L1 immune checkpoint inhibitor, durvalumab (MEDI4736), in a global Phase II study in patients with previously treated squamous or non-squamous non-small cell lung cancer (NSCLC). The randomized Phase II trial will be conducted by Peregrine. As part of the Phase II bavituximab and durvalumab combination trial, patients will be evaluated retrospectively for the correlation between their PD-L1 levels and clinical outcomes. This new study builds on the non-exclusive collaboration initiated between the companies in August 2015 to conduct a Phase I/Ib basket clinical trial evaluating the combination of bavituximab and durvalumab with chemotherapy in multiple solid tumors. Bavituximab and durvalumab are investigational immunotherapies with different mechanisms that assist the body's immune system in fighting cancer. Bavituximab targets and modulates the activity of phosphatidylserine, a highly immune-suppressive molecule expressed broadly on the surface of cells in the tumor microenvironment. In pre-clinical and translational clinical studies, the treatment increases activated T-cells in tumors and fights cancer by reversing the immunosuppressive environment that many tumors establish in order to proliferate. Durvalumab is a monoclonal antibody directed against programmed cell death ligand 1 (PD-L1). Signals from PD-L1 help tumors avoid detection by the immune system. Preclinical data have demonstrated that combining the enhanced T-cell mediated anti-tumor activity of bavituximab with checkpoint inhibitors, like PD-L1 antibodies, prolong the ability of tumor-specific T-cells to continue attacking the tumor. "In the short period of time that we have been working with AstraZeneca, we have been very impressed with the company's commitment to innovative translational efforts that will help us better understand the dynamics of tumor immunity and clinical response to durvalumab and bavituximab combination in a range of cancers," said Mr Joseph Shan, vice-president, clinical and regulatory affairs of Peregrine. He added, "We expect this extension of our collaboration with AstraZeneca will allow us to run a much more cost-effective and time-efficient trial than would have been possible under our previously planned study using Opdivo as the combination drug in the same lung cancer population. This Phase II study offers several key advantages including a supply of durvalumab that will enable us to conduct a global trial that can enroll patients more rapidly. In addition, the expanded collaboration provides for a more cohesive clinical program utilizing the same PD-L1 and other biomarker analysis across both the new Phase II trial and the already planned Phase I/Ib study combining durvalumab and bavituximab in multiple indications." ]]> <![CDATA[Biocon Q2FY16 Revenues up 12%; Net Profit up 200% ]]> https://biospectrumindia.com/news/95/6828/biocon-q2fy16-revenues-up-12-net-profit-up-200-.html https://biospectrumindia.com/news/95/6828/biocon-q2fy16-revenues-up-12-net-profit-up-200-.html Wed, 21 Oct 2015 10:05:31 +0530 Bangalore based Biocon recorded 200 percent growth in its net profit for the second quarter ended September 30, 2015 compared to corresponding period previous fiscal.The company has recorded Rs 306 crore net profit for the second quarter compared to Rs 102 crore for the same period previous fiscal. For the second quarter, Biocon's total income was Rs 828 crore, an increase of 11 percenet over Rs 750 crore registered during the previous fiscal same period. Commenting on the quarterly performance and highlights, Chairperson and Managing Director, Kiran Mazumdar-Shaw stated:"It has been a stable performance for Biocon this quarter with several growth triggers on the horizon focusing on Biosimilars in emerging markets. The clinical advancement of five of our Biosimilars programs has put us on track for regulatory filings for some of these in the US and Europe in FY17. The inauguration of our world-class manufacturing facility for a new generation insulin delivery device and the launch of BASALOG One, a high-end, ready-to-use Insulin Glargine disposable pen in India, widens our insulins offering to diabetics in India. Our renewed focus on key brands has improved profitability of our Branded Formulations business. We expect the clinical progress in Biosimilars and Novels to augur well for the company, going forward." During Q2FY16, R&D spends of the company was at Rs.57 Cr represented an increase of 64% YoY, largely on account of the clinical advancement of several Biosimilars and Novel programs. Biocon's four Biosimilars programs partnered with Mylan, have made good clinical progress this quarter, says company. As previously stated, patient recruitment in the Insulin Glargine global Phase III trials were completed in the first quarter of this fiscal. Patient recruitment for multi-centric global Phase III clinical trials for Pegfilgrastim and Trastuzumab are nearing completion while the global Phase III clinical trial for Adalimumab is progressing well across multiple sites. The global Phase I PK study for Bevacizumab is approaching completion while the ROW focused Phase III trial is advancing as per plan. The encouraging clinical advancement across all our programs puts us on track for regulatory filings for some of these molecules in the developed markets of U.S. and Europe, in FY17, said company in its release. For the quarter, the Biopharmaceutical segment grew 4% YoY, delivering sales of Rs.578 Crore. Within the segment, Biopharma grew 4% delivering Rs.459 Crore, while Branded Formulations grew 3% to Rs.119 Crore. The overall performance of Biopharma business this quarter was affected due to slow offtake of some of the APIs and capacity constraints. However, we are taking steps to address this challenge, said company. "Our Insulins facility in Malaysia is progressing towards qualification and emerging market filings in FY17. The expansion of our Biosimilars fill-finish facility in Bangalore is also on track for qualification in FY18', said company. "Furthermore, we continue to pursue licensing opportunities in emerging markets for two key products, Trastuzumab and Insulin Glargine, and expect to commence sales of these products in some of these markets, this fiscal", company added. We have recently acquired the business assets including a USFDA approved synthesis facility of Acacia Life Sciences, in Vishakhapatnam, India. It presently manufactures advanced intermediates of potent APIs with sales to customers in India and overseas. This acquisition will enable us to vertically integrate our oncology related ANDA filings of the future, company stated. ]]> <![CDATA[Syngene Q2 net profits up 31% over previous year]]> https://biospectrumindia.com/news/95/6827/syngene-q2-net-profits-up-31-over-previous-year.html https://biospectrumindia.com/news/95/6827/syngene-q2-net-profits-up-31-over-previous-year.html Wed, 21 Oct 2015 09:48:17 +0530 Bangalore based Syngene International recorded net profit of Rs 52.3 crore for second quarter ended September 30, 2015, registering an increase of 31 per cent compared to the same period last year. The total income of the company for the July-September period was Rs.261.4 crore against Rs.201.9 crore for corresponding period in the previous year. Commenting on the company's performance Peter Bains, Executive Director and Chief Executive Officer, Syngene said, "We are very pleased to report a comprehensively strong set of numbers for HI FY16. We have witnessed sustained momentum in our business across our dedicated centres, discovery and development service platforms." "Our recent capacity expansion in manufacturing services, has helped us keep pace with the increasing requirements of our clients," Bains said. For the six months ended September 30, the company posted a net profit of Rs 95.93 crore as compared to Rs 74.56 crore in the same period of previous fiscal. Meanwhile the company has appointed Dr Thomas Privette as the head of business development and Dr Gregory Bisacchi as the head of discovery chemistry. ]]> <![CDATA[Hot Start-up: Cleanergis Biosciences]]> https://biospectrumindia.com/features/95/5387/hot-start-up-cleanergis-biosciences.html https://biospectrumindia.com/features/95/5387/hot-start-up-cleanergis-biosciences.html Tue, 20 Oct 2015 17:25:32 +0530 "I came up with the idea of starting up my company catering to the industrial needs using my expertise in the industrial biotechnology. With years of expertise, I believed I can achieve something significant in this area," states Dr Sangeeta, founder & director, Cleanergis Biosciences. She is a trained biotechnologist with a PhD from Indian Institute of Science (IISc). Her doctoral thesis focused on viral vaccines. Post which, she pursued her post-doctoral research at the University of France, Paris, in Oncology. Dr Sangeeta then worked for Cadila Pharmaceuticals and Aurigene Discovery. The turning point came in when she got a break at the Danish enzyme firm - Novozymes. She managed Novozymes' R&D activities in Bangalore. At Novozymes, her interest grew manifold in the industrial applications of enzymes. "My interest became stronger to explore the possibilities of solving core problems faced by industries. The challenges were to develop efficient, innovative and clean methods to solve those problems," Dr Sangeeta adds. The year was 2012. The idea of forming a company had already conceived in her mind. By February 2013, she established Cleanergis Biosciences and got it registered. With customized solutions, flexible scale, and proprietary technologies, Cleanergis Biosciences works in partnerships to ensure efficient and high-quality protein production, process development and scale-up production of biologics for research and commercial purposes. The company is currently focused on technologies that would help in producing food preservatives, and food grade enzymes. "For this, we have already established collaborations with Indian and foreign companies," reveals Dr Sangeeta. No Exceptions So far, Cleanergis has been funded by the founder, along with the good support of family and friends. She says that availability of funds is a major challenge faced by any start-up in the country. "Cleanergis is no exception to this," says Dr Sangeeta. "Organizing funds was a primary concern. Hence it was difficult to set-up the necessary laboratory infrastructure initially. As any other biotechnology company, we also faced challenges with availability of necessary equipments. Also, getting information in the form of patents, reports, and scientific protocols was a challenge, either due to funds or reliability. Getting the right contacts for demonstrating the technologies and establishing right partnerships were also challenges that we had to face." "Attempts have been made to get government grants, and partial grants have been granted for one of our projects. The company now is on an aggressive look-out for additional funds through venture capital sources and business collaborators," voices Dr Sangeeta. She also feels that working with established partners would be one of the best ways to prove a technology's worth, and build a start-up enterprise. Dr Sangeeta points that the Biotechnology Ignition Grant (BIG) provided by the Department of Biotechnology (DBT) can also be one of the best ways to raise start-up cash, followed by angel investments. Government & Entrepreneurship She strongly believes in the essentiality of the Government in encouraging innovation and entrepreneurship. "The society at large benefits from a successful enterprise, and hence it is essential for the Government to encourage more and more start-ups. The Indian Government, through various schemes such as the Biotechnology Ignition Grant for biotech start-ups, has significantly contributed to this. In addition, to encourage innovation, the Government should give grants to researches to accomplish research in a start-up environment. The role of mentoring start-ups should also be aggressively conducted by the Government to help start-up enterprises to succeed and grow," she mentions. Technologies & IPs So far, Cleanergis has developed three powerful technologies -- two for the food industry, and one in the area of waste-water treatment. It has established business relationships with two food processing companies. "Our first collaboration involves the development of technologies for better shelf-life of certain food that are exported. The second collaboration is in food processing with a Spanish company, on strain improvement of certain microbes that produce enzymes for meat processing. This collaboration would benefit Cleanergis by establishing strong IP. Apart from this, Cleanergis is also working on efforts to build a technology in bioremediation of industrial effluents, where we have partnered with companies in waste-water treatment," Dr Sangeeta highlights. With products under development specifically for the food industry, Cleanergis is looking forward to partner with more companies in this area. "We are also looking at offering services in the area of microbial technology to companies on a fee-for-service basis," she says. Based in Bangalore, the company expects to have a few products in the next one year, upon which it would either consider to out-license or market them with partners. "From the current focus of purely technology development, we plan to expand our capabilities to patent our inventions and out-license the technologies. We plan to establish teams in international business development and small scale manufacturing. As we grow, we also plan to strengthen our R&D," she explains. In the upcoming year, the start-up plans to consolidate its IP position by filing patents for some of its innovations. New Entrepreneurs She advises new entrepreneurs to begin a start-up by exploring strong ideas and developing prototypes that will have a great demand in the market. "Be frugal as much as possible in your spending, and have faith in yourself. One needs to be perfect in planning on all aspects. One should keep their start-up stress under control by keeping their fears under tight control. Also one needs to keep hopes alive and be optimistic," she opines. Start-up Visibility She also states that it is essential for start-ups to be noticed by investors and possible collaborators at all times. "Though, essentially a start-up needs funding, it is more important that the technologies or services that it develops have traction with potential customers and collaborators. Companies need to be proactive and take up opportunities that lead to visibility - opportunities such as competitions, seminars, and other platforms," she remarks. Areas of Opportunities Apart from industrial applications in biotechnology, she claims Healthcare and Diagnostics as areas with huge potential for biotechnology start-ups. She sees Delhi and Pune as the next emerging start-up hubs in the country. Dr Sangeeta explains, "The conditions prevailing in these cities are far conducive to start-ups. Availability of good infrastructure and trained manpower in these cities are great assets. These cities have good incubation facilities, venture capital hubs and technology advisors." Encouraging Innovation & Risk As a technology-driven start-up, she observes that innovation is the backbone for any company. "We have a motto which says, 'No idea is a bad idea'. Everybody in the company is encouraged to share ideas," she comments. Having witnessed research abroad, she points that in the developed West, all infrastructural requirements such as incubators, communication, transport, electricity, water, and consumables are easily available, and don't interfere with basic needs. "In the West, funding scenario is healthier, as the culture thrives on innovation. Therefore, a lot of angel and venture funds encourage entrepreneurship and risk-taking. The West also adapts to good IP regulation and technology transfer initiatives, where start-ups can look forward to culminate their innovations. If India can imitate this, it'd work wonders for start-ups," Dr Sangeeta urges. IIMs & IITs What are the essential qualities of being a Life Sciences entrepreneur? "It is important to have patience, and also being organized, disciplined, and knowledgeable. Entrepreneurs have to be sure of where they are heading at various stages in their endeavor, hence they need to stick to their set plan," she stresses. She also voices that it is not necessary to have advanced degrees or have education from IITs or IIMs to be an entrepreneur. "However, these qualifications bring in an advantage of being trained and supported in planning and execution during the early stage of a start-up. With the right kind of support system, anybody can be an entrepreneur in the life science industry," Dr Sangeeta emphasizes. She feels that India does not have educational institutes with exceptional qualities, except only for a few institutes including the IITs or IIMs. "Candidates from such institutes are well-trained and also do exceptionally well in creative areas such as innovation and entrepreneurship. Hence, society favors them while others who are equally good, if not better, are ignored," she notes. Start-up Incubators Dr Sangeeta says that it is both advantageous and disadvantageous for start-ups working in an incubator or an accelerator. She justifies, "Most of the start-ups are cash starved and are also in a mode of planning, organizing resources and execution. Whereas, incubators are well organized and dedicated to certain activities. If the start-up projects are dedicated and time-bound, it would be immensely beneficial to work in an incubator. "There would be several occasions where a start-up may not function in an organized way, and would have to change plans due to several constraints. In such a situation, working in an incubator may hinder such activities. According to me, it is better to start elsewhere and grow, unless the projects are dedicated and time-bound." When does selling a Life Sciences start-up make sense? "It would definitely be sensible to sell it when one sees value in the company, either through projects, collaborations or revenues. When there are products or technologies under development that would impact, it would be sensible to go ahead and convey this to a larger audience of venture funds and collaborators," she clearly says. Biotech Start-up Boom To kick-start biotech start-up boom in India, she adds that there must be more rewards offered for budding entrepreneurs. "The rewards can be in the form of cash rewards, seed funds, and associations with other business partners. Also more news about the progress of the start-ups need to be shared in the media. Conferences should dedicate space for start-ups," she suggests. Well, what would it take for a Life Sciences start-up to become India's next billion-dollar enterprise? She adds, "Firstly the start-up needs to cater to an industry that can generate such revenues. The two focused areas are agriculture and health. The health sector is an ever challenging sector, and disease management would always be a priority area. Any exciting thoughts and technologies catering to this field may eventually turn out to be the next billion-dollar enterprise." As a final thought Dr Sangeeta shares, "As a life sciences entrepreneur, it is exciting to venture out with offerings that can really impact the business scenario. It is challenging at every stage to make best of the opportunity, but certainly there are several hurdles one needs to overcome." Common Entrepreneurial Mistakes To Avoid: ï‚§ Lack of knowledge of market needsï‚§ Not having a goalï‚§ Lack of advisors or mentorsï‚§ Not understanding Life Sciences businessï‚§ Unmindful of investments consumptionï‚§ Improper planning ï‚§ Untimely execution of projects ]]> <![CDATA[AstraZeneca India wins OPPI Marketing Excellence Award 2015]]> https://biospectrumindia.com/news/95/6216/astrazeneca-india-wins-oppi-marketing-excellence-award-2015.html https://biospectrumindia.com/news/95/6216/astrazeneca-india-wins-oppi-marketing-excellence-award-2015.html Tue, 20 Oct 2015 16:10:00 +0530 AstraZeneca India, a leading biopharmaceutical company which is part of AstraZeneca Pharma India, was awarded the prestigious Dr H R Nanji Memorial OPPI Marketing Excellence Awards 2015 on October 20th for BRILINTA (Ticagrelor 90 mg), its innovative treatment solution for Acute Coronary Syndrome (ACS). As per AstraZeneca, its medico-marketing initiatives, based on delivering and pursuing excellence in science, have helped improve the lives of patients suffering from ACS in India. BRILINTA is one of the leading brands by Value Market Share in the Oral Anti-platelet market and remains committed to continue drive a paradigm shift in the way ACS is managed in India AstraZeneca India received this Award in the "Best New Pharma Product launch" category. The Award was given by Dr V K Subburaj, secretary, department of pharmaceuticals, government of India. AstraZeneca India also supported the 'OPPI Woman Scientist Award 2015' received by Prof Vandana B. Patravale from ICT, Mumbai. This Award recognizes outstanding women research scientists in the field of human healthcare. Prof Vandana B. Patravale holds expertise in the development of novel, cost effective and robust technologies in the field of nano-drug delivery, nano-diagnostics, vaccines and biomedical devices. Her research in malaria prevention and therapy has seen significant success in terms of one granted patent and ready- for-transfer scalable technologies for effective malaria management in cases of pregnancy, and cerebral malaria. Dr Bhavesh Kotak, vice president, Medical and Regulatory Affairs, AstraZeneca India said, "ACS causes 28% of all cardiovascular deaths globally and there is a huge unmet medical need in this area. We are pleased to receive this recognition for our efforts in improving the lives of ACS patients in India. Additionally as a science-led organisation, we trust in the potential of ideas and support the efforts of research scientists such as Prof Vandana B Patravale." ]]> <![CDATA[Jubilant Life Sciences receives ANDA approval for Rizatriptan Benzoate OD tablets]]> https://biospectrumindia.com/news/95/7045/jubilant-life-sciences-receives-anda-approval-for-rizatriptan-benzoate-od-tablets.html https://biospectrumindia.com/news/95/7045/jubilant-life-sciences-receives-anda-approval-for-rizatriptan-benzoate-od-tablets.html Tue, 20 Oct 2015 12:24:58 +0530 Jubilant Life Sciences Ltd, an integrated global Pharmaceuticals and Life Sciences Company, has received Abbreviated New Drug Application (ANDA) final approval from the US Food and Drug Administration (US FDA) for Rizatriptan Benzoate Orally Disintegrating Tablets, 5 mg and 10 mg. The generic version of Maxalt-MLT Orally Disintegrating, 5 mg and 10 mg Tablets (of Merck), which is indicated for the acute treatment of migraine in adults and in pediatric patients. As on June 30, 2015, Jubilant Life Sciences had a total of 815 filings for formulations of which 389 have been approved in various regions globally. This includes 72 ANDAs filed in the US, of which 38 have been approved and 46 Dossier filings in Europe. ]]> <![CDATA[ABLE joins global partnership to develop hookworm vaccine]]> https://biospectrumindia.com/news/95/6536/able-joins-global-partnership-to-develop-hookworm-vaccine.html https://biospectrumindia.com/news/95/6536/able-joins-global-partnership-to-develop-hookworm-vaccine.html Mon, 19 Oct 2015 13:17:56 +0530 The Amsterdam Institute for Global Health and Development (AIGHD) and Sabin Vaccine Institute Product Development Partnership (Sabin PDP) have recently formed a new research and innovation partnership with the Association of Biotechnology Led Enterprises (ABLE) of India on vaccine development for hookworm and other neglected tropical diseases (NTDs). The European Union, through its EuropeAid program, recently awarded a five-year grant of â‚¬333,000 to AIGHD to establish this EU-India partnership. This new initiative announced on October 14, 2015, aims to build a network of partners who can provide low-cost vaccine manufacturing for hookworm infection and, at a later stage, other NTDs. In particular, the partnership will identify viable paths toward manufacturing a human hookworm vaccine that costs less than US$1 per dose. It will also work to advance the acceptance and introduction of these vaccines in India and other endemic countries. Other partners include FlandersBio and Q-Biologicals in Belgium, and Baylor College of Medicine in the United States. "Building on global efforts to develop a hookworm vaccine, this partnership will allow the EU biotech industry to share expertise with Indian vaccine manufacturers, which have proven abilities in bringing safe, effective and low-cost vaccines, such as ROTAVAC, to market," said Dr Remko van Leeuwen, project director for the HOOKVAC Consortium at the Amsterdam Institute for Global Health and Development. "India, in particular, accounts for 35 percent of the global burden of NTDs. Given their high burden and successful vaccine manufacturing track record, we see strong potential for producing a hookworm vaccine with partners in India." Approximately 477 million people worldwide suffer from hookworm, making it one of the most pervasive NTDs affecting people living in extreme poverty. Left untreated, hookworm causes internal blood loss leading to iron-deficiency anemia and protein malnutrition, particularly in pregnant women and children. Chronic hookworm infection in children contributes to physical and intellectual impairment, and poor school performance. "ABLE is proud to join the European Commission in their efforts to fight hookworm infection and other diseases of poverty," said Dr P M Murali, president of ABLE. "We hope to use this opportunity to exchange knowledge and resources and create an innovative and collaborative environment for the joint development of safe and affordable vaccines. "The Sabin PDP is thrilled to engage in this new initiative, which promotes greater innovation and collaboration with India," said Dr. Peter Hotez, president of Sabin, director of the Sabin PDP and dean of the National School of Tropical Medicine at Baylor College of Medicine. "Furthermore, it provides an opportunity to explore new partnerships for the Sabin PDP and build on years of research and development efforts to combat the persistent scourge of NTDs." ]]> <![CDATA[Dr Kiran Mazumdar on what's trending in India's Biotech ]]> https://biospectrumindia.com/news/95/8313/dr-kiran-mazumdar-on-whats-trending-in-indias-biotech-.html https://biospectrumindia.com/news/95/8313/dr-kiran-mazumdar-on-whats-trending-in-indias-biotech-.html Fri, 16 Oct 2015 16:09:00 +0530 The three-day BIB 2016 is scheduled for February 9-11, 2016, at Hotel Lalit Ashok, in Bangalore. The theme for this most-anticipated upcoming biotech event has been identified as, ''What's Trending in Biotech India'. In her address, Dr Kiran spoke about the happening trends in the biotech space. "BIB 2016 is going to be very exciting and encouraging because of the trends that we are seeing in the biotech. Trends, not just in our country, but worldwide. In India, it is very clear that biotechnology now is a rapidly growing sector. Through the 'Make-in-India' campaign, India is beginning to focus on biopharmaceuticals, vaccines and medical device areas which are becoming trend setters," she pointed. She believes that India will play an important role in biotechnology. "There are big opportunities in the start-ups space. Bangalore is certainly becoming very-well recognized world over as a start-up hub," added Dr Kiran. Dr Kiran mentioned Genomics as one of the biggest trends in the biotech space. She commented, "Many companies in the Genomics and BioIT space have started gaining traction. They started in and hesitant way. However, they are making big strides today. Given Bangalore's IT prowess, Genomics and BioIT is going to be a big trend setter that we need to be watching out." Dr Kiran named a few companies which are making strides in the Genomics and BioIT space, including, Mapmygenome, Bigtec Labs, Ganit Labs and Genotypic Technology. The second trend she voiced, pointed to the area of biosimilars. "India is the pharmacy of the world, and it has a large space in generics. We want to emulate this success in biosimilars as well. What we need to do to be successful in the biosimilars sector is ensure that we grow this ecosystem in terms of scientists and clinicians, and everyone needed including engineers, geneticists, and microbiologists, and create a large ecosystem. Both, biomanufacturing and biosimilars, are big opportunities for India," she opined. She also feels that Vaccines can be another big area for India. "India is already playing a leadership role in vaccines, and will continue to forge ahead," she said. Dr Kiran emphasized about India's opportunities in the Ayurveda space. "Ayurveda should open up more in India. We have not leveraged the treasure trove of Ayurveda in this country. We should look at our own knowledge, and that could be a big trend. We must create that trend from India," she encouraged. Moving towards agri-biotech, she stated, "We are the largest producers of Bt Cotton seeds, but haven't gone beyond that. For many years, our efforts in agri-biotech has been thwarted by narrow-minded and unscientific decisions. Agri-biotech is not just about recombinant technology. It is about understanding molecular markers, enhancing productivity, and design hybrids better, with an aim of addressing food security." She shared the importance of creating a trend in sustainable development through biotech. "Biotech in waste management has big opportunities. Renewable energies is another area where biotech has a huge role to play. Veterinary Sciences also presents exciting opportunities which leverages biotech, thereby enhancing and improving veterinary sector in a new way," she revealed. She further added, "These are not just opportunities to catch-up with the global trends, but to create new trends from our own nation. Dr Kiran also made references to Gene- and Proteomics-based strategies to study diseases and disease markers, as happening trends in biotech. She concluded by saying, "There are lot of opportunities in diagnostics. Every company today is looking at developing companion diagnostics. Precision medicine is another big trend in the world and it depends a lot on diagnostics. These are the trends we need to catch-up with and trends we need to set." Ms V Manjula, IAS, Principal Secretary, Department of IT, BT and S&C, Government of Karnataka, also addressed the delegates. "The Karnataka's biotech policy has been updated from time-to-time. During BIB 2016, we'll further update the policy in tune with the requirements of the sector," she remarked. The Government of Karnataka has come up with a bioventure fund worth Rs 50 crore in collaboration with VC firms. Karnataka will invest Rs 13 crore, and the rest will be open for VCs investments. The Government of Karnataka is also setting up incubation centers for biotech start-ups in partnership with Central Food Technological Research Institute (CFTRI, Mysore), University of Agricultural Sciences (UAS, Dharwad) and University of Veterinary Sciences at Bidar. ]]> <![CDATA[Merck brand relaunched ]]> https://biospectrumindia.com/news/95/7419/merck-brand-relaunched-.html https://biospectrumindia.com/news/95/7419/merck-brand-relaunched-.html Fri, 16 Oct 2015 15:52:00 +0530 Germany: Merck, a leading science and technology company, today announced the relaunch of its brand identity. The fundamental revision of the visual appearance as well as the introduction of a new logo reflect the transformation into a global science and technology company. At the same time, the brand architecture at business level has been simplified. Outside the United States and Canada, the company will operate uniformly as Merck. "Merck has fundamentally changed over the past ten years," emphasized KarlLudwig Kley, Chairman of the Executive Board and CEO. "We have developed from a classic supplier of pharmaceuticals and chemicals into a global technology company. With our unique combination of highly specialized biopharmaceutical, life science and materials businesses, we are in a position today to offer solutions to support global megatrends such as health and digitization. The complete overhaul of our brand identity is to communicate this new direction vis-Ã -vis our customers, partners and applicants. We want to be recognizable and remain visible as Merck worldwide so as to strengthen our well-known brand name. For this we have deliberately rid ourselves of outdated features and will be focusing on a young and eye-catching image." The investment in the Merck brand is part of the "Fit for 2018" strategic transformation and growth program, which includes the focus on innovative, technology-driven businesses as well as the modernization and expansion of global headquarters in Darmstadt, Germany. This also involves a more self-confident and at the same time clearer tone of voice, reflecting Merck's character and linking its pride in a nearly 350-year-old culture with scientific curiosity and a passion for research. With the introduction of the new brand design, the previously independent divisional brands Merck Serono and Merck Millipore will be eliminated. In the future, Merck Serono will operate as the biopharmaceutical business of Merck, and Merck Millipore as the life science business of Merck. "Following the two major acquisitions, the Merck Serono and Merck Millipore brands helped us to position the duality of existing and acquired businesses in the marketplace. We succeeded in doing so. That's why we are returning to the brand that we have been known under for nearly 350 years," Kley added. Product brands such as Erbitux or MilliQ will not be affected by this change. Merck holds the rights to the Merck name and brand globally. The only exceptions are the United States and Canada. The company will therefore continue to operate in these two countries as EMD Serono in the biopharmaceutical business, as EMD Performance Materials in the high-tech materials business, as well as EMD Millipore in the life science business up until the planned acquisition of Sigma-Aldrich has been completed. Merck's visual image is fundamentally new. It is based on the concept of a vibrant science and technology company, and is inspired by the colorful and multifaceted shapes seen under a microscope. The new Merck design features expressive colors and shapes with a scientific look-and-feel. These are also reflected by the new company logo. In comparison with the former logo, it makes a bold statement; its design is less complex and can be used in different colors. "A comprehensive external and internal analysis showed that we must emotionalize our brand appearance to a much greater extent in order to be perceived as a vibrant technology company in the market and by applicants," said Walter Huber, Head of Group Communications. In addition, the new corporate design is to create a strong visual link to the Merck businesses in the United States and Canada. For this reason, the company is also introducing a striking, multi-colored "M" in addition to the Merck logo. It is to indicate the membership of businesses and products to the Merck Group, independent of company names or regions. In its brand repositioning efforts, Merck was supported by FutureBrand, a leading brand agency. ]]> <![CDATA[FDA nod for Aurobindo Pharma's dementia drug]]> https://biospectrumindia.com/news/95/7492/fda-nod-for-aurobindo-pharmas-dementia-drug.html https://biospectrumindia.com/news/95/7492/fda-nod-for-aurobindo-pharmas-dementia-drug.html Fri, 16 Oct 2015 11:39:45 +0530 Aurobindo Pharma is pleased to announce that the company has received the final approval from the US Food and Drug Administration (US FDA) to manufacture and market Memantine Hydrochloride Tablets, 5mg and 10mg (ANDA 203175). This approval is an extension of tentative approval received on 24 March 2014. The product is ready for launch. The approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) NAMENDA 5mg and 10mg of Forest Laboratories. Memantine Hydrochloride Tablets are used for the treatment of moderate to severe dementia of the Alzheimer's type. The approved product has an estimated market size of $1.23 billion for the twelve months ending August 2015 according to IMS. ]]> <![CDATA[Bangalore INDIA BIO 2016 from February 9th to 11th 2016]]> https://biospectrumindia.com/news/95/7290/bangalore-india-bio-2016-from-february-9th-to-11th-2016.html https://biospectrumindia.com/news/95/7290/bangalore-india-bio-2016-from-february-9th-to-11th-2016.html Thu, 15 Oct 2015 15:46:49 +0530 Bangalore: The Department of Information Technology, Biotechnology and Science & Technology, Government of Karnataka, Vision Group on Biotechnology and MM Activ Sci-Tech Communications today announced that Bangalore INDIA BIO (BIB) 2016 with the core Theme 'What's Trending in BIOTECH INDIA' will be held from 9th to 11th February, 2016 at Bangalore. The announcement was made today by Mr S.R. Patil, Minister for IT, BT and S&T, Govt. of Karnataka, in the presence of members of the Vision Group. The announcement included an overview of the activities planned during Bangalore INDIA BIO 2016 Conference & Exhibition. Bangalore INDIA BIO 2016: Bangalore INDIA BIO 2016 will consist of Multi-Track Conferences, International Tradeshow, Distinguished Lectures & Talks, Poster Session, Bio-Excellence Awards, Global Biotech Conclave, InterlinX BioPartnering, BioQuiz, Bio Accelerate Programme & other Networking Events. The Event is expected to have 20 Conference Sessions addressed by over 110 Experts, about 100 Exhibitors and will see 3000 plus Business visitors. International representation is expected from nearly 15 countries including USA, Canada, Australia, France, Germany, The Netherlands, Belgium European Union, Korea, Taiwan, Malaysia, SAARC and other South East Asian Countries. The International Conference will deliberate on issues of pressing interest to the Biotech sector including Oncology, Rare Diseases & Orphan Drugs; Proteomics; Big Data & Analytics and IoT; CRAMS and CROs; Agribiotechnology for Food, Feed, Fuel & Fiber Security; International Day and Biotech Finishing Schools - Industry HR Interaction Workshop. The Tradeshow will see exhibits from leading Corporate, Best R&D Institutes, Start-Up 15, States of India, Academia as well as Small & Medium companies showcasing their Technologies, Products & Services; focused pavilions will see participation from consortiums of various industry verticals like Bio Pharmaceuticals; Process Engineering; Laboratory Technology; Contract Services; IT; Medical Technology; AgriBiotech & BioFuels; Business Services and Industrial Biotech. Bangalore INDIA BIO will also be partnering with major industry associations from the Analytical Instrumentation, Medical Diagnostics and Devices, Clinical Research & Contract Research and other to provide them with a platform for business networking. There will be a special emphasis on Micro & Small Enterprises that will connect them with International and Indian Companies as well. Global Biotech Conclave will be a high powered panel discussion wherein Global Experts will deliberate on What's Trending in BIOTECH INDIA. This will be an exclusive gathering of the Biotech Community (CEOs, R&D Heads, Policy makers, Venture Capitalists, Investment Bankers, etc.) KBITS (Govt. of Karnataka) will organize the "Bio-Accelerate" programme - a Live Business plan competition for Start-Ups, who are given an opportunity to present their concepts and ideas. Short-listed companies will present their business plans before a grand jury of industry and Govt. of Karnataka officials. Bangalore INDIA BIO 2016 will include BioPartnering for B2B, B2G and G2G, which will be powered by InterlinX - a Powerful Internet Platform and software networking tool that helps delegates of BIB to maximize their time at the event by scheduling meetings before, during and after the event. Bio Excellence Awards will recognize the contribution of Start-Up & Young Biotech Companies and Individuals for their outstanding achievements in the field of Biotechnology. The selection process is conducted by ABLE. Exhibitor Awards and Best Poster Awards are presented during the programme. Over 100 Young Researchers will present innovations through Poster Sessions - Walkway of Discovery. The event will also include Bio-Excellence Awards Ceremony that will recognize the contributions of Biotech Companies and Individuals for their outstanding achievements in the field of Life Sciences and Biotechnology. BioQuiz, India's largest State Level quiz on Biotechnology will be organized by the Department of IT, BT and Science & Technology, Government of Karnataka with the objective to create awareness and help students understand Science and Biotechnology and know about the immense potential that the Indian biotech sector holds. It is open to B.Sc, B.Sc-Agri, and B.E - Biotechnology & B.Pharma students from across the Karnataka. ]]> <![CDATA[Pfizer's India MD resigns from his post ]]> https://biospectrumindia.com/news/95/7075/pfizers-india-md-resigns-from-his-post-.html https://biospectrumindia.com/news/95/7075/pfizers-india-md-resigns-from-his-post-.html Wed, 14 Oct 2015 17:57:11 +0530 As per one of its filings to Bombay Stock Exchange on October 13, 2015, the pharma major, Pfizer's managing director, Mr Aijaz Tobaccowalla has resigned from the post and his resignation would be effective from October 16th of this month. Earlier Mr Tobaccowalla has intended to step down from his position on June 5th this year, the company informed. Succeeding Mr Kewal Handa, he was appointed on this post in August, 2012. The company also stated that its day-to-day operations will be managed by the executive director-business unit and distribution head, Mr S Sridhar till the time the name of Mr Tobaccowalla's successor is announced. Pfizer said in a filing to the BSE said, "The day-to-day operations of the company shall be managed by S Sridhar, presently the executive director, Business Unit and Distribution Head, until such time that Tobaccowalla's successor is appointed by the Board of Directors." ]]> <![CDATA[Sphaera Pharma's drug modification technology gets USPTO green signal]]> https://biospectrumindia.com/news/95/3490/sphaera-pharmas-drug-modification-technology-gets-uspto-green-signal.html https://biospectrumindia.com/news/95/3490/sphaera-pharmas-drug-modification-technology-gets-uspto-green-signal.html Wed, 14 Oct 2015 17:25:30 +0530 Sphaera Pharma has received a notice of allowance from the United States Patent and Trademark Office (USPTO) for its Patent application titled 'Substituted methylformyl reagents and method of using same to modify physicochemical or pharmacokinetic properties of compounds', for its proprietary platform technology. Drug Modification Technology (DMT) platform can help address sub-optimal physico-chemical and pharmacokinetic properties of approved drugs and drugs in development. Sphaera's technology allows for improved delivery of a drug, parenterally or orally, by improving its pH independent solubility and can be easily implemented for almost any drug. Some applications include development of pediatric formulations and alternate dosing forms for approved drugs. Sphaera is advancing multiple drugs using this approach through the various stages of pre-clinical and clinical development and expects the first US FDA approved clinical trial in the US with a NCE developed using this technology by a licensee early next year. Dr Sundeep Dugar, Founder of Sphaera Pharma commented - "We are very pleased by this development. This not only brings significant credible external validation of the quality of intellectual property developed by Sphaera but also enhances the value of drugs developed using this platform for our current and potential partners. Our DMT platform provides an excellent opportunity for existing generic companies to move up the value chain by Rescuing, Recovering, Re-purposing and Re-positioning of drugs." Sphaera Pharma is an integrated drug discovery and development organization led by pharma and biotech professionals. With its global presence in India, Singapore and the US, Sphaera aims to bridge innovation, resources and expertise in a collaborative model to develop novel therapies. ]]> <![CDATA[â€œYoung researcher need to focus more on the agricultureâ€?]]> https://biospectrumindia.com/interviews/95/6873/young-researcher-need-to-focus-more-on-the-agriculture.html https://biospectrumindia.com/interviews/95/6873/young-researcher-need-to-focus-more-on-the-agriculture.html Wed, 14 Oct 2015 14:21:39 +0530 Please tell us about your feelings on being awarded by Thomson Reuters? I really feel humbled and honoured to receive Research Excellence Citation Award by Thomson Reuters. I would like to dedicate this award to my PhD students, Postdocs, colleagues and collaborators from ICRISAT as well as all other organizations with whom I got an opportunity to work with on different exciting projects. I am also grateful to my teachers, mentors, friends and well-wishers. I express my sincere gratitude to my family especially my children and wife for their unconditional support throughout. According to you what is more important: publication or product development oriented research? In my opinion, both publications and product oriented research are important and I don't think that these two things are exclusive to each other. Product oriented research is a direct solution to a challenge, for example bringing superior, high yielding, resistant varieties to markets and fields will help farming and consumer community directly. At the same time, publications are the best knowledge sharing tools to advance science and technology and to train the next generation of scientists to take up new and ambitious challenges. In order to bring an easy access to all readers we believe and promote open access repositories of the research. What is your advice to the young researchers of India who sometimes feel left out due to glamour and comfort of the jobs? For all citizens of a nation, it is an obligation to contribute towards the growth of the country in different and any possible way. In my opinion, different fields, be it arts, engineering, finance, medicine, etc. are of equal importance. But for a country like India where agriculture remains the main mean of earning livelihood for rural people that consitutes major part of India, there could not be anything more contributing than agriculture. Apart from it today almost a billion people worldwide live in a state of hunger. Moreover, there would be a steep elevation in these figures by 2050. Simultaneously climatic changes are resulting in huge crop losses every year and making the scenario worsen. Research in field of agriculture has become "A call of the hour", as basic to everything comes down to "Food". Young researcher need to focus more on the agriculture as the field is with vast ocean of opportunities and rewarding too, in coming future. What are the research initiatives taken by ICRISAT in decoding genomes of various crops of importance? How will it benefit the nation? Before I joined ICRISAT in 2005, there were very limited genomics resources available for the ICRISAT mandate crops like chickpea, pigeonpea and groundnut. These crops, though are very important for ensuring food and nutritional security, have not been given much importance at international level and used to be called "orphan crops". Application of molecular breeding to enhance crop productivity in these crops was a daunting task. In the last 5-6 years, ICRISAT with its noble mission to benefit small holder farmers in the terms of economic opportunity and consumers in the form of improved nutrition, led demand-driven innovations in genomics science. We floated various genome sequencing consortia such as International Initiative on Pigeonpea Genomics where using whole genome shotgun sequencing approach, we completed the sequencing of pigeonpea, the first non-industrial legume crop for which a genome sequence became available in 2012. We also led International Chickpea Genome Sequence Consortium and completed the genome sequencing of chickpea variety in 2013. We have become the first institute of the CGIAR and the first institute based in India who published genome sequences as lead in the topmost science journals like Nature Biotechnology. Recently, we as a leader for the International Pearl Millet Genome Sequencing Consortium also completed genome sequencing of pearl millet. ICRISAT has also collaborated with the partners in International Peanut Genome Initiative for decoding draft genome for both the diploid progenitors while co-led with colleagues from China another initiative Diploid Progenitor Peanut A-genome Sequencing Consortium (DPPAGSC) for sequencing the A-genome progenitor. By using molecular breeding methodologies, ICRISAT has been successful in developing superior lines with enhanced drought tolerance as well as with enhanced resistance to Fusarium wilt and Ascochyta blight diseases in in chickpea. In the case of groundnut improved lines have been developed with enhanced resistance to leaf rust and with enhanced high oil quality. Molecular breeding lines are expected to be released as improved varieties in due course. This will provide a better produce and more income to farmers of India. It is important to note here that crops like chickpea, groundnut and pigeonpea are grown by small-holder farmers and therefore enhanced crop productivity of these crops will help and mean a lot to the farmers. Secondly, India, despite being the major producer for the pulses and oilseed crops, still imports these crops in large quantity. Enhanced crop production will contribute to make India self- reliant in these crops. What is the current focus of your research group? In order to capture the genetic variation present in germplasm collections and to identify superior alleles for the target traits currently, we are engaged at present in whole genome resequencing projects. One of them is 'The 3000 Chickpea Genome Sequencing Initiative' in which we are sequencing and also phenotyping 3000 accessions of chickpea from the genebank. We are accelerating molecular breeding activities by targeting drought tolerance in chickpea, disease resistance and oil quality in groundnut. In order to harvest maximum from the genomic blue prints developed, we are also working on transcriptomics, gene expression atlas and proteome maps of our crops. Results obtained through these commutative efforts will not only enhance our understanding towards the gene function, characterization, gene discovery, protein interactions but will also allow selection of better alleles for crop improvement. ]]> <![CDATA[Generics, small molecule injectables to drive growth, says Piramal]]> https://biospectrumindia.com/news/95/3275/generics-small-molecule-injectables-to-drive-growth-says-piramal.html https://biospectrumindia.com/news/95/3275/generics-small-molecule-injectables-to-drive-growth-says-piramal.html Wed, 14 Oct 2015 14:14:00 +0530 Singapore: India's Piramal Enterprises' Pharma Solutions division, focused on contract development and manufacturing (CDMO), has indicated that near-term growth prospects are highest across generics, small molecule injectables, and in contract services. Mr Vivek Sharma, CEO, Pharma Solutions, Piramal Enterprises, commented, "We recently acquired Coldstream in Kentucky, USA, to enhance our sterile injectables service offering. We expect that over the next few years there will be further acquisitions by both generic and big pharma players as companies look to gain a foothold in the growing sterile injectables space. In particular, we see this access to manufacturing infrastructure as a key driver for future consolidations." The company, in its report, highlight that the United States remains the primary outsourcing destination, particularly for high value and biological formulations. However, in the longer term, it is predicted that lower cost firms in India and China may try to enter with generic injectables. Over the next few years, CMOs focused on prefilled syringes and those with high potent handling capabilities are expected to be the biggest beneficiaries of market growth. Mr Sharma further added, "Outsourcing in the sterile injectable segment is still focused on the US, followed by the European Union. We anticipate this market to continue growing at around 10 percent annually for the next 5 years, with the US remaining the most preferred outsourcing destination." Small molecule injectables are likely to expand at a faster rate than steriles, albeit from a lower base, with oncology and anti-infectives representing just over 50% of the total market. In biologics, monoclonal antibodies (mAbs) account for the largest market share, followed by vaccines and insulin. "Demand for cutting edge injectable capabilities should grow as ADCs and other high value products dominate the 'potent' development space. Nevertheless, the primary driver behind the growth in injectables is the generic market. Growth in the generic injectables is outpacing growth on the innovator side. By the year 2020, we expect this market to double to circa US USD70 billion", added Sharma. Technology is also a key component in companies' prospects, and drug delivery systems such as liposomes, PEGlyation and Depot Injections will play an important role. The use of these technologies should see a spurt in growth, especially in therapeutic segments that require efficient targeting of drugs. Overall, conditions remain positive, but there could be challenges for some smaller firms due to high capital and operational costs along with the complex compliance requirements for approval, the report indicates. This potential reduction in competition may also be augmented by consolidation. Finally, Piramal suggests that there may be more collaborative partnerships between larger and newer players, to overcome any in-house technology gaps. ]]> <![CDATA[Roche to buy Adheron Therapeutics ]]> https://biospectrumindia.com/news/95/5330/roche-to-buy-adheron-therapeutics-.html https://biospectrumindia.com/news/95/5330/roche-to-buy-adheron-therapeutics-.html Wed, 14 Oct 2015 12:18:00 +0530 Adheron Therapeutics, a privately held biotechnology company based in Berkeley, California, United States, has announced that it has agreed to be acquired by Roche. Adheron Therapeutics has developed a pioneering technology that disrupts immune cell adhesion through a cell surface protein called Cadherin-11 in order to develop potential treatments for a variety of inflammatory and autoimmune diseases such as rheumatoid arthritis and fibrotic diseases. The lead asset, SDP051, a humanized monoclonal antibody targeting Cadherin-11, has completed Phase 1 of clinical development. "We are very excited about this acquisition, as it is an important step towards the development of breakthrough medicines in the area of inflammation and fibrosis," said Mr Hari Kumar, chief executive officer of Adheron Therapeutics. He added, "This deal brings together Adheron's deep understanding of the underlying science of Cadherin-11 with Roche's vast experience in researching and developing next generation medicines. We are proud to move our promising investigational medicine to the next level and into a new home at Roche." Under the terms of the agreement, Adheron's shareholders will receive an upfront cash payment of $105 million, plus additional contingent payments of up to $475 million based on achievement of certain predetermined milestones. The transaction is subject to customary closing conditions and anticipated to close shortly. ]]> <![CDATA[Helsinn, Dr Reddy's settle patent dispute ]]> https://biospectrumindia.com/news/95/6845/helsinn-dr-reddys-settle-patent-dispute-.html https://biospectrumindia.com/news/95/6845/helsinn-dr-reddys-settle-patent-dispute-.html Wed, 14 Oct 2015 11:42:59 +0530 Helsinn Healthcare SA announces that it has entered into a settlement agreement with Dr Reddy's Laboratories to resolve certain patent litigations relating to Helsinn Healthcare's Aloxi (palonosetron HCl injection) in the United States, where it is currently distributed by Helsinn Healthcare's marketing partner, Eisai. As a result of the settlement, Dr Reddy's will be permitted to market a 505(j) generic version of Aloxi in the United States on September 30, 2018 or earlier under certain circumstances. The terms of the settlement agreement are otherwise confidential. ]]> <![CDATA[Hottest Indian start-ups on the block: Geniron Biolabs]]> https://biospectrumindia.com/features/95/7625/hottest-indian-start-ups-on-the-block-geniron-biolabs.html https://biospectrumindia.com/features/95/7625/hottest-indian-start-ups-on-the-block-geniron-biolabs.html Tue, 13 Oct 2015 17:55:24 +0530 Starting-Up Geniron's founders and veterinarians Dr Goutham (28) and Dr Prashanth (28) quit their cushy dream jobs to begin their new chapter as entrepreneurs. Dr Goutham, who hails from sub-urban Hassan, worked as a veterinary officer with the Government of Karnataka, while Dr Prashanth from Anekal was employed with the iconic Bangalore-based Biocon. The duo pursued their Bachelor's studies together in Veterinary Science in Bidar. It was then both of them dreamt of starting their own venture. At the same time, Dr Goutham and Dr Prashanth began to pursue their Master's degree in the same space, specializing in Veterinary Microbiology and Animal Biotechnology respectively. Armed with extensive knowledge in Veterinary and having seen issues surrounding animal healthcare in India, both of them started Geniron, with the aim of serving the animal industry through vaccines and diagnostics, along with contract research services in animal studies to serve the pharma and biopharmaceutical industry. However, it took 5 years to start the company with a clear, concrete idea and definite vision. Adds Dr Goutham, "There was always an itch in us to start a venture. In our third year during undergraduate studies, we both decided to start our own company, but we had a lot of different ideas to start-up in the animal husbandry and healthcare sector." Awards Into Investments However, the path became very clearer after the duo won the BEST-ABLE award in 2012. "It made a larger impact, and we chose to be in the animal healthcare sector and started Geniron," says Dr Prashanth. The prize money was carefully invested in the development of the company. Investments worth Rs 20 lakh from family and friends were also pooled in. The company's establishment -- from registration to the setting-up of the infrastructure facility -- was shared equally between the two. "From then on it has been a roller coaster ride," says Dr Goutham. "Later, for our R&D, we were awarded with BIG funding from DBT, which gave us a boost for developing products and procurement of equipments," recalls Dr Prashanth. Till now the company has invested nearly Rs 40 lakh, majorly for equipments and infrastructure. "Initially there were challenges during setting-up of facilities, especially the laboratory animal facility. The approvals needed for the facility and registrations with the government took a snail's pace, taking about more than a year or so. With respect to R&D, we were a little challenged, whether to go on with our own facility or approach an incubation center," says Mr Goutham, who is an avid avian photographer. Dr Prashanth advises that starting-up on own is the ideal way if there is a cash flow model along with the R&D. "But for a start-up with a primary focus on R&D, they should seek to be incubated or join an accelerator as it reduces the burden of purchasing and maintaining of instruments. Proper and clear guidance through mentors in the incubator makes R&D easier," he reasons. Vaccine Pipeline The Bangalore-based company is working on novel animal vaccines, diagnostics and nutraceuticals towards enhancing animal health and productivity. It is also working on a complete technology package for Rabies eradication in India, as per the recommendations of World Health Organization (WHO), in terms of combined DNA for Rabies and contraception. Currently the company offers contract research services in animal-related studies, from antibody services to pre-clinical trials. "In the future we'll have 3 to 4 animal vaccine candidates and diagnostic kits for both humans and animals, which are in the pipeline, and will be launched in 4 years," reveals Dr Goutham. The company now caters to various research institutes, colleges, start-ups in biotech, and major MNCs. Expanding Abroad Geniron is now looking at great opportunities in animal healthcare sector for vaccines and diagnostics, mainly because of the increase in organized dairy farms, and sheep & goat farms, which are gaining popularity in India. "Along with that, there is an increasing trend in having companion animals in India," says Dr Prashanth. "With respect to CRO, we are expanding the infrastructure and upgrading to GLP facility in order to serve and partner with the pharmaceutical industry in drug discovery and development," points Dr Goutham. At the moment, Geniron aims to scale-up within India. "Right now, there is no intention of expansion to other countries. Maybe 5 to 6 years down the lane we would be interested in expanding to the US, Europe and Africa," opines Dr Prashanth. Revenue Targets Since the company is in its R&D phase, the focus for the next 2 years will be concentrated towards product development and market launch. "In our contract research services, we are having a target of Rs 3 crore as revenue generation in the next couple of years," shares Dr Goutham. Funding Flummoxes Since the beginning of Geniron's establishment, it is actively pursuing R&D collaborations with Centre for Cellular and Molecular Platforms (C-CAMP), and Institute of Biotechnology and Applied Bioinformatics (IBAB). Today, ideas and innovations of start-ups are taking healthcare and lifestyle of people into the next level. "The major constraint for a start-up is the financial support, since the gestational period of product development is 2 to 5 years. Government should take a major role in funding start-ups in Life Sciences industry through grants and soft loan schemes," suggest both the founders. Dr Prashanth emphasizes that when it comes to funding, Government grants should be the top priority for a start-up. "It is crucial to have financial support with adequate mentoring and monitoring from agencies to help start-ups reach their goal. Next on the list are angel investors, and lastly, venture capitalists," he expresses. He also points that billion-dollar start-ups are possible in India when innovative ideas of the new generation are supported and nurtured by the Government and big players in the industry. Are there any unusual ways of funding Life Sciences start-ups? "Yes," says Dr Goutham. "If a start-up has a product or a service idea, which has the applicability as a byproduct to other companies, then it should approach those companies explaining how it can solve their problems. In the process the company ends up funding the start-up, and in turn help take the start-up's research to the next level or make a finished product." West's Style Dr Prashanth stresses that in the Western countries, there are major collaborations happening between the academia and start-ups, where they work together to develop a product. The academia usually licenses out the shared patent to start-ups, which enables cash flow for the start-up's further establishment, making it to stand as a unique enterprise in the market or industry. "But in India," Dr Goutham says, "there are no major academic and startup tie-ups for invention of a product or technology. This is the need of the hour. Our Government should take initiatives towards making this work." Shareholders & Returns In the eyes of Dr Goutham, Pune and Chennai seems to be the next upcoming hub for biotech start-ups mainly due to conducive institutional support available for start-ups. In the tech industry, the gestation period is short for product development, and the product lifecycle may vary between 2 to 5 years, where investors can expect returns very early. "Whereas," explains Dr Goutham, "Life Sciences industry is a long-term investment, where the gestation period for a product is 5 to 9 years, and product lifecycle is up to 20 years. Investors in Life Sciences should invest and relax for higher returns in the longer duration." Relentless Journey Dr Goutham says that in-depth knowledge and passion is more important to be an entrepreneur in Life Sciences. "Degrees do add value or give a tag to establish in the market, but most of the great inventions were invented by college drop-outs" he points. Failure is a part of entrepreneurial journey, remarks Dr Prashanth. "Never be depressed, and opportunities are like buses. If you miss it, the next one will be ready, but you have to be ready and prepared to get into the bus and seize the opportunity," he states. He continues, "Never wait for the right time and never think too much about the pros and cons of a venture. Just start at it! Take calculated risks, and never think negatively. Just enjoy the moment." Adding to this, Dr Goutham says, "If you have a unique idea which can be commercialized and can make an impact on the world, just jump and indulge in it. Thinking too much doesn't make the impact. But action does!" Dr Goutham concludes saying that he keeps himself enthused by reading motivational books. "As I said earlier, entrepreneurship is a roller coaster ride. There are ups-and-downs. We usually read good motivational books and engage in TED videos to boost ourselves and bounce back with more enthusiasm," he concludes. Entrepreneurial Mistakes To Avoid: 1. Being too ambitious2. Assuming product acceptance as easier3. Diverting or deviating from company's primary focus ]]> <![CDATA[Indonesia based Dermozone enters Indian Market]]> https://biospectrumindia.com/news/95/7616/indonesia-based-dermozone-enters-indian-market.html https://biospectrumindia.com/news/95/7616/indonesia-based-dermozone-enters-indian-market.html Tue, 13 Oct 2015 11:37:38 +0530 Dermozone, the renowned Indonesia based herbal skin care products company, has announced its entry into the Indian market. The company has set up its office in Bengaluru in the name of Indo-Dermozone Herbal. Dermozone also announced the appointment of Mr Manjunatha KG as chief operation officer of Indo-Dermozone Herbal, who would lead and oversee the Indian operations. Mr Manjunatha has over 27 years experience in technology and management and brings together entrepreneurial drive and vision with exceptional technology know-how to launch new products, build new competencies and penetrate lucrative market niches. Dermozone is globally recognized for its wide range of herbal skin care products especially its flagship brand- MedCare Ozonated Olive Oil, primarily used for the treatment of Acne, Fungal Infections, Dry Skin, Insect Bites, Athlete's Foot, Eczema, Blisters, Carbuncles, Diabetic Wounds, Burns, Cuts, Wounds and Vaginal Thrush. "We are extremely excited about our plans to enter the Indian market and will be soon formally launching our flagship product MedCare Ozonated Olive Oil," said Mr KS Dharshan, chairman and CEO of Dermozone. He added, "After 14 years of extensive research, MedCare Ozonated Olive Oil has pioneered into a product that repairs, rejuvenates and refines your skin, keeping it in top condition. With the goodness of Mother Nature, used by people across the globe, MedCare heals wounds and solves your everyday skin problems." Headquartered in Indonesia, Dermozone also has operations in UK, USA, Japan, Russia, Seoul and China. ]]> <![CDATA[Dignity is a daunting challenge in mental health: WHO]]> https://biospectrumindia.com/news/95/6842/dignity-is-a-daunting-challenge-in-mental-health-who.html https://biospectrumindia.com/news/95/6842/dignity-is-a-daunting-challenge-in-mental-health-who.html Mon, 12 Oct 2015 14:20:41 +0530 "This day is an opportunity to reflect on where we are and what we need to do to make mental health care a reality for people around the world," said Dr Poonam K Singh, WHO's regional director for South-East Asia. Mental, neurological and substance use disorders are common all over the world, affecting every community and age group and across all income countries. While 14% of the global burden of disease is attributed to these disorders, most of the people affected, almost 75% in many low-income countries, do not have access to treatment that they need. "Dignity is one of the most daunting challenges in mental health," Dr Poonam added. "Dignity in mental health means steps are taken to safeguard the well-being of people with mental health conditions, thus liberating them from the shackles of self-stigma, low-confidence, low-self-esteem, withdrawal, and social isolation. To break the barrier of prejudice and insensitivity, dignity and mental health have to go hand-in-hand. We will achieve dignity for mental health when communities, families and individuals have the confidence to seek help for mental health without fear and inhibition." WHO said that it is committed to working towards a future when people with mental health conditions will live a life of dignity, a fundamental human right. WHO promotes a shift from long-stay mental hospitals, which is in itself stigmatizing, to care in community-based settings which are more acceptable and dignified. "Together we need to ensure that mental health strategies, actions and interventions for treatment, prevention and promotion are compliant with the Convention on the Rights of Persons with Disabilities and other international and regional human rights instruments," ended Dr Poonam. ]]> <![CDATA[J&J starts clinical trial of Ebola vaccine in Sierra Leone]]> https://biospectrumindia.com/news/95/7533/jj-starts-clinical-trial-of-ebola-vaccine-in-sierra-leone.html https://biospectrumindia.com/news/95/7533/jj-starts-clinical-trial-of-ebola-vaccine-in-sierra-leone.html Mon, 12 Oct 2015 11:46:30 +0530 Johnson & Johnson (J&J) has announced the start of a safety and immunogenicity clinical trial in Sierra Leone of a preventive Ebola vaccine regimen in development at its Janssen Pharmaceutical Companies. Trial recruitment is underway, and the first volunteers have received their initial vaccine dose. This is the first study conducted of Janssen's Ebola prime-boost vaccine regimen in a West African country affected by the recent Ebola epidemic. The new study, EBOVAC-Salone, will take place in Sierra Leone's Kambia district, where some of the country's most recent Ebola cases have been reported. The regimen being tested uses a combination of two vaccine components based on AdVac technology from Crucell Holland B.V., one of the Janssen Pharmaceutical Companies, and MVA-BN technology from Bavarian Nordic. Volunteers in the study will first be given the AdVac dose to prime their immune system, and then the MVA-BN dose two months later to boost their immune response, with the goal of potentially strengthening and optimizing the duration of the immunity. "Never again can Ebola be allowed to cause the human suffering that the world has witnessed in West Africa and we remain committed as ever to helping the international community combat this disease," said Dr Paul Stoffels, chief scientific officer and worldwide chairman, Pharmaceuticals, J&J. He added, "One of the many lessons learned from the outbreak is we cannot let our guard down with Ebola, and we need to test every promising prevention tool. It is our hope that this study will help to confirm the value of this vaccine regimen in Ebola control efforts - not just for Sierra Leone, but for the world." Professor Peter Piot, director of the London School of Hygiene and Tropical Medicine, which is one of the partners conducting the study, said, "We cannot afford to be complacent about Ebola. We urgently need a vaccine that offers long-term protection of the population, including health workers and other care givers, in order to prevent a resurgence of the virus. To achieve this goal, it is vital to test a range of vaccine candidates, particularly in the areas affected by the epidemic where we are still seeing new cases emerging, and there is evidence that the infection may have longer-term effects among survivors. Prime-boost vaccination is an effective strategy for long-term prevention of several infectious diseases, and we believe it may have a key role to play in the fight against Ebola." The EBOVAC-Salone study is notable in that it will evaluate the vaccine regimen's safety and immune response within the general population of Sierra Leone, including vulnerable groups such as adolescents, children, and people with HIV. In addition to the London School of Hygiene & Tropical Medicine which is coordinating the EBOVAC-Salone trial, Janssen is partnering with Sierra Leone's Ministry of Health and Sanitation, the College of Medicine and Allied Health Sciences, and two consortia of which Janssen is a member that are funded by Europe's Innovative Medicines Initiative (IMI): EBOVAC1 (Ebola Vaccine Development), which is conducting the study, and EBODAC (Ebola Vaccine Deployment, Acceptance & Compliance), which is developing a communication strategy and tools to promote the acceptance and uptake of the Ebola vaccine regimen. From the outset, the EBOVAC-Salone team's goal has been to conduct a study that meets Sierra Leone's Ebola prevention needs, has the support of the Sierra Leonean people, and can play a sustaining role in helping to restore the country's health infrastructure following the Ebola outbreak. Significant investment has been made to build new facilities in Kambia to conduct the study, which will contribute substantially to the strengthening of the local health system. These include establishing the first Emergency Room at the Kambia District Hospital, and building a new vaccine storage facility on the hospital site. These efforts are complemented by the employment and training of doctors, nurses and other frontline health care workers who will gain valuable experience while contributing to the clinical study. The EBOVAC-Salone study is being initiated on a parallel track with multiple ongoing Phase I and II studies that are being conducted across the US, Europe and Africa as part of the accelerated development plan for the Ebola vaccine regimen. First-in-human Phase I clinical studies of the prime-boost vaccine regimen began in the United Kingdom and United States in January 2015, followed by several sites in Africa. In May 2015, Johnson & Johnson presented promising preliminary data from the UK Phase I study to the US Food and Drug Administration (US FDA). A Phase II study, being carried out in the UK and France, started in July 2015, and a second multi-site Phase II study will shortly commence in several West and East African countries in outside epidemic areas. These Phase II studies are being coordinated by Institut National de la Sante et de la Recherche Medicale (Inserm), another consortium partner with Janssen. To date, there is no licensed vaccine, treatment or cure for the Ebola virus. The Ebola outbreak in West Africa began in March 2014 and has put the health care systems of Sierra Leone, Liberia and Guinea under tremendous pressure. As of October 2015, over 28,400 people have been infected with the virus across the three countries, and nearly 11,300 have died - including more than 500 health care workers. In Sierra Leone specifically, nearly 14,000 cases of Ebola have been reported and nearly 4,000 people have died. ]]> <![CDATA[FDA nod for Aurobindo's anti-psychotic tablets ]]> https://biospectrumindia.com/news/95/7531/fda-nod-for-aurobindos-anti-psychotic-tablets-.html https://biospectrumindia.com/news/95/7531/fda-nod-for-aurobindos-anti-psychotic-tablets-.html Mon, 12 Oct 2015 11:46:00 +0530 Aurobindo Pharma has announced that the company has received the final approval from the US Food and Drug Administration (US FDA) to manufacture and marketAripiprazole Tablets, 2mg, 5mg, 10mg, 15mg, 20mg and 30mg (ANDA 203908). The product is ready for launch. The approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) Abilify Tablets 2mg, 5mg, 10mg, 15mg, 20mg and 30mg of Otsuka Pharmaceutical Company (Otsuka). Aripiprazole Tablets are a typical anti-psychotic indicated in the treatment symptoms of psychotic conditions such as schizophrenia and bipolar disorder (manic depression). The approved product has an estimated market size of $7.3 Billion for the twelve months ending August 2015, according to IMS. This is the 48th ANDA to be approved out of Unit VII formulation facility in Hyderabad, India for manufacturing Oral Non-Antibiotic products. Aurobindo now has a total of 215 ANDA approvals (187 Final approvals including 10 from Aurolife Pharma and 28 Tentative approvals) from the US FDA. ]]> <![CDATA[Torrent Pharma's board approves Zyg Pharma's merger]]> https://biospectrumindia.com/news/95/6990/torrent-pharmas-board-approves-zyg-pharmas-merger.html https://biospectrumindia.com/news/95/6990/torrent-pharmas-board-approves-zyg-pharmas-merger.html Fri, 09 Oct 2015 17:51:07 +0530 Torrent Pharmaceuticals' management has given approval to the scheme of amalgamation of its subsidiary Zyg Pharma with the company. The company in a filing to BSE said, "The Board of Directors of the Company has approved the Scheme of Amalgamation of Zyg Pharma Private Limited ('Zyg' or 'Transferor Company'), a wholly owned subsidiary of the Company with Torrent Pharmaceuticals Limited ('the Company' or 'Transferee Company') and their respective Shareholders and Creditors after taking into consideration Recommendation Report of the Audit and Risk Management Committee, subject to approval of Stock Exchange, SEBI and other Government authorities as well as the Hon'ble High Court of the concerned Judicature." The appointed date for the amalgamation is October 01, 2015, the company added. ]]> <![CDATA[The first international conference on sustainable chemistry and engineering hosted in Mumbai]]> https://biospectrumindia.com/news/95/7239/the-first-international-conference-on-sustainable-chemistry-and-engineering-hosted-in-mumbai.html https://biospectrumindia.com/news/95/7239/the-first-international-conference-on-sustainable-chemistry-and-engineering-hosted-in-mumbai.html Fri, 09 Oct 2015 17:50:38 +0530 First of its kind, SusChemE, an international conference on sustainable chemistry and engineering was inaugurated in Mumbai on Thursday with eminent scholars, scientists, industry leaders participating. The two day conference organized by Institute of Chemical Technology, Mumbai had expert lectures, technical presentations and CEO conclaves under different topics of sustainability. The sessions were on nanotechnology, wastewater treatment, catalysis, bio-catalysis, energy and collaborations of industry and science, which got concluded on Friday. Padma Vibhushan Prof. M M Sharma, Emeritus professor of eminence, ICT, said "there is nothing called waste in chemistry and engineering in sustainable point of view. Time has already changed and used many which were previously considered as wastes. For a better environment friendly chemistry, people in education and industry should come together to innovate the way we use our resources today. Sustainability is attained only when there there is an improvement in efficiency." Prof. G D Yadav, vice chancellor, ICT, said "Swatch Bharat is an initiative of Indian government to clean our society and maintain beauty of environment. Sustainability in chemical and engineering can contribute to this initiative in a big way. In fact there is a need for innovation and collaborative functioning in this industry to make it possible. Manipulation of older methods for strengthening of industrial functioning and altering the way of innovation will be crucial for future movements." Jae Sung Lee, School Energy and chemical engineering, Ulsan National institute of science & technology, Korea, said "Green chemistry aims to efficiently utilize renewable raw materials, eliminate waste and avoid use of toxic and hazardous reagents and solvents in the manufacture and application of chemical products. Hence advancements in catalytic science and technologies through nanotechnology are most impacted and vital. The syntheses of chemical usually happen through multiple catalytic steps. The world population is rising at an alarming rate, particularly in the developing world. There will be a huge resource crunch and providing sustainable supply of energy and materials is a herculean task." ]]> <![CDATA[Cipla Medpro partners with Serum to provide vaccines in South Africa]]> https://biospectrumindia.com/news/95/6567/cipla-medpro-partners-with-serum-to-provide-vaccines-in-south-africa.html https://biospectrumindia.com/news/95/6567/cipla-medpro-partners-with-serum-to-provide-vaccines-in-south-africa.html Fri, 09 Oct 2015 11:26:47 +0530 Cipla Ltd. has announced that its South African subsidiary Cipla Medpro (Pty) Ltd. has entered into an exclusive agreement with the world's largest vaccine manufacturer, Serum Institute of India (SII) in South Africa. Mr Paul Miller, CEO of Cipla Medpro, South Africa said: "This agreement will enable Cipla Medpro to become a significant player in the market. With a presence in 140 countries and 1.3 billion doses manufactured and sold, SII is an ideal ally for Cipla Medpro and this partnership will be instrumental in addressing the national vaccine shortage." SII manufactures a variety of vaccine classes including vaccines for Polio, Diphtheria, Tetanus, BCG (Tuberculosis), Hepatitis B, Measles, Mumps and Rubella; South Africa will be participating in the majority of these portfolios. Mr Michel Baijot, head of Vaccines, Cipla Ltd., said, "This Cipla Medpro - SII agreement reflects again the complementarities of our two like-minded companies in bringing high quality, affordable vaccines to more countries." The agreement stipulates that Cipla Medpro will become the holder of all Medical Control Council (MCC) regulatory approvals such as product registrations and marketing authorizations. Cipla Medpro has exclusivity and first right of refusal of the SII pipeline within South Africa. Mr Adar Poonawalla, CEO and Executive Director, SII said: "SII is looking to extend the strong partnership it has with Cipla in Europe and India by working with Cipla Medpro in South Africa." ]]> <![CDATA[Study of DNA repair gets Nobel prize in Chemistry 2015]]> https://biospectrumindia.com/news/95/7329/study-of-dna-repair-gets-nobel-prize-in-chemistry-2015.html https://biospectrumindia.com/news/95/7329/study-of-dna-repair-gets-nobel-prize-in-chemistry-2015.html Thu, 08 Oct 2015 17:17:39 +0530 Each day our DNA is damaged by UV radiation, free radicals and other carcinogenic substances, but even without such external attacks, a DNA molecule is inherently unstable. Thousands of spontaneous changes to a cell's genome occur on a daily basis. Furthermore, defects can also arise when DNA is copied during cell division, a process that occurs several million times every day in the human body. The reason our genetic material does not disintegrate into complete chemical chaos is that a host of molecular systems continuously monitor and repair DNA. The Nobel Prize in Chemistry 2015 awards three pioneering scientists who have mapped how several of these repair systems function at a detailed molecular level. Dr Tomas Lindahl, Dr Paul Modrich and Dr Aziz Sancar have been awarded for having mapped, at a molecular level, how cells repair damaged DNA and safeguard the genetic information. Their work has provided fundamental knowledge of how a living cell functions and is, for instance, used for the development of new cancer treatments. The Nobel Laureates in Chemistry 2015 have provided fundamental insights into how cells function, knowledge that can be used, for instance, in the development of new cancer treatments. While Dr Tomas Lindah is associated with the Francis Crick Institute and Clare Hall Laboratory, Hertfordshire, UK, Dr Paul Modrich works at the Howard Hughes Medical Institute and Duke University School of Medicine, Durham, NC, USA. Dr Aziz Sancar is based out of University of North Carolina, Chapel Hill, NC, USA. Ground breaking work In the early 1970s, scientists believed that DNA was an extremely stable molecule, but Tomas Lindahl demonstrated that DNA decays at a rate that ought to have made the development of life on Earth impossible. This insight led him to discover a molecular machinery, base excision repair, which constantly counteracts the collapse of our DNA. Aziz Sancar has mapped nucleotide excision repair, the mechanism that cells use to repair UV damage to DNA. People born with defects in this repair system will develop skin cancer if they are exposed to sunlight. The cell also utilises nucleotide excision repair to correct defects caused by mutagenic substances, among other things.Paul Modrich has demonstrated how the cell corrects errors that occur when DNA is replicated during cell division. This mechanism, mismatch repair, reduces the error frequency during DNA replication by about a thousandfold. Congenital defects in mismatch repair are known, for example, to cause a hereditary variant of colon cancer. ]]> <![CDATA[Ensure universal access to comprehensive eye care services: WHO]]> https://biospectrumindia.com/news/95/6543/ensure-universal-access-to-comprehensive-eye-care-services-who.html https://biospectrumindia.com/news/95/6543/ensure-universal-access-to-comprehensive-eye-care-services-who.html Thu, 08 Oct 2015 14:37:31 +0530 WHO South-East Asia has 140 million visually impaired people. The region has an estimated 12 million blind people, 8 million of them in India. More than 50% of all blindness is caused by cataract which accounts for 33% of visual impairment. Uncorrected refractive errors are responsible for 43% of the visual impairment in the Region. About 65% of the visually impaired people are 50-year-old and above. "These statistics should be viewed against the fact that 80% of visual impairment is avoidable. And that the blindness prevention strategies and restoration of sight are among the most cost-effective interventions in health care," said Dr Poonam Khetrapal Singh, Regional Director, WHO South-East Asia Region. She further added, "To reduce avoidable blindness and visual impairment, we must ensure universal access to comprehensive eye care services. There is a need to review and reinforce existing measures so that nobody suffers visual impairment and those with unavoidable vision loss can still achieve their full potential." The WHO Global Action Plan (GAP) for the Prevention of Avoidable Blindness and Visual Impairment 2014-2019, emphasizes on improving eye health for everyone and reducing the prevalence of avoidable blindness and visual impairment by 25% by the year 2019. Dr Poonam pointed that implementing simple measures such as eye care services in schools can help detect and correct refractive errors in children. "And quality surgical procedures can help cataract patients get back to normal lifestyle very quickly," she stressed. The World Sight Day is an opportunity to raise public awareness against blindness and visual impairment, and advocate for designating more resources for national blindness prevention programmes, said WHO in a press statement. "Together we can make VISION 2020, the global initiative for the elimination of avoidable blindness, a reality," concluded Dr Poonam. ]]> <![CDATA[NHL treatment pipeline shows below average innovation]]> https://biospectrumindia.com/features/95/8190/nhl-treatment-pipeline-shows-below-average-innovation.html https://biospectrumindia.com/features/95/8190/nhl-treatment-pipeline-shows-below-average-innovation.html Thu, 08 Oct 2015 13:45:24 +0530 The product pipeline for NHL exhibits a lower degree of innovation than both the industry and oncology average, with just 28% of all pipeline products, or 33% of the pipeline for which there is a disclosed molecular target, categorized as first-in-class. This is in comparison to industry, breast cancer and lung cancer innovation rates of 43%, 57% and 59%, respectively, says business intelligence provider GBI Research. The company's latest report states that while NHL, collectively, is the sixth to tenth most common cancer dependent on territory, each individual subtype is classified as an orphan disease. With significant differences in each subtype's genetic profile and current treatment, there is reduced scope for the development of a targeted therapy with cross-subtype activity. This does not present NHL drug development as an attractive investment in comparison to other indications in oncology, particularly as survival durations across many NHL subtypes are relatively strong, and likely the reason for low first-in-class innovation levels. However, Ms Katie Noon, senior analyst for GBI Research, says that innovation is present to varying degrees across the majority of molecular target families and development stages for NHL therapeutics, rather than localized to a particular subset of therapies. Ms Noon says: "There is a considerable range of clinical potential across treatments with first-in-class status, particularly those restricted to the early-stage NHL pipeline. Some targets, such as spleen tyrosine kinase, boast plenty of supporting scientific and clinical evidence, while others have shown mixed results in Preclinical studies and lack clarity on their role in disease pathophysiology." She continues: "It is hoped that one of these many targeted therapy pipeline products will replicate the success observed with rituximab, which significantly altered the NHL treatment landscape following its approval. "Clear gaps in the treatment algorithm include maintenance therapies to prolong initial or subsequent durations of remission, and improved therapies for relapsed patients, particularly those with a second or subsequent relapse," the analyst concludes. ]]> <![CDATA[Mumbai gets its first set of Apollo Sugar Clinics for diabetes care]]> https://biospectrumindia.com/news/95/7039/mumbai-gets-its-first-set-of-apollo-sugar-clinics-for-diabetes-care.html https://biospectrumindia.com/news/95/7039/mumbai-gets-its-first-set-of-apollo-sugar-clinics-for-diabetes-care.html Wed, 07 Oct 2015 17:57:44 +0530 Apollo Sugar Clinics Ltd (ASCL), an innovative, single specialty diabetes and endocrine healthcare service provider announced its entry into Mumbai with the opening of 4 neighborhood care delivery centers in Vile Parle, Kandivili, Chembur and Tardeo. The launch event was hosted by Ms. Sangita Reddy, Chairperson, Apollo Sugar Clinics Ltd. and Joint Managing Director, Apollo Hospitals Enterprise Ltd., and Mr. Gagan Bhalla, Chief Executive Officer, Apollo Sugar Clinics, and graced by Dr. Shailesh Ayyangar, Managing Director, India & Vice President, South Asia - Sanofi, Dr. Shashank Joshi, President, Indian Academy of Diabetes and Practicing Endocrinologist and Dr Sanjiv Shah, Board Member, Indian Academy of Diabetes & Indian Medical Association and Lead Consultant, Apollo Sugar Clinics Mumbai. Designed to provide the best standards of services and facilities for diabetes care, Apollo Sugar is equipped with a highly trained, experienced and compassionate team of doctors and multi-disciplinary care team members including specialized dieticians, educators, and diabetes trained nurses. Apollo Sugar aims at bringing world class diabetic care to the doorsteps of Mumbai citizens using a comprehensive, evidence based care approach. It is a one stop shop that offers high quality end to end comprehensive care across clinical and lifestyle aspects of managing diabetes. Each neighborhood clinic ranges from 750 - 1000 sq ft and the larger formats providing advanced care have an expanse of 2000-4000 sq ft. The new centers offer access to Apollo's world class clinical infrastructure, diagnostics, access to lifestyle management and patient support programs through the use of advanced technology among many other associated services. Commenting at the launch, Sangita Reddy, Chairperson, Apollo Sugar and Joint Managing Director, Apollo Hospitals said "Apollo Sugar has benchmarked global best practices in quality healthcare delivery with stringent alignment to approved standards and protocols. With the increasing burden of diabetes in our society, we need to act quickly. Apollo Sugar has therefore set foot in Mumbai to offer patients advanced care and counseling for diabetes. We aim to have many more centers spread across more neighborhoods in Mumbai to ensure proximity of people with diabetes, to world class care." Speaking on the occasion, Gagan Bhalla, Chief Executive Officer of Apollo Sugar said, "We believe proven, world-class care for diabetes needs to be accessible to Mumbaikars in their neighborhood given how difficult travel can be across Mumbai. Apollo Sugar with the launch of its four new centers in the city of Mumbai endeavors to deliver end-to-end diabetes care through its holistic diabetes and lifestyle management programmes. Built on the 30 year legacy of Apollo, Apollo Sugar Clinics aim to help Mumbaikars live a disease free diabetes lifestyle. We promise to hand-hold Mumbaikars in managing their Diabetes by delivering proven and internationally acclaimed standards of care at affordable price points, thus helping improve their quality of life by preventing and reducing complications." Dr. Shailesh Ayyangar, Vice -President - South Asia, Sanofi said, "Sanofi has a heritage of nearly 100 years in developing treatments for diabetes, and understands the impact of integrated diabetes management and innovative care models can have for, patients with diabetes. Through Apollo Sugar Clinics, both Apollo Hospitals and Sanofi India are working towards a common endeavor of improving integrated diabetes care and infrastructure in India." ]]> <![CDATA[AZ sells rare disease drug to Genzyme]]> https://biospectrumindia.com/news/95/7538/az-sells-rare-disease-drug-to-genzyme.html https://biospectrumindia.com/news/95/7538/az-sells-rare-disease-drug-to-genzyme.html Wed, 07 Oct 2015 16:52:10 +0530 Genzyme made an upfront payment to AstraZeneca of $165 million to acquire the global rights to sell and develop Caprelsa, and will make further development and sales milestone payments of up to $135 million. The transaction does not include the transfer of any AstraZeneca employees or facilities. The divestment reinforces AstraZeneca's strategic focus on its three main therapy areas. As an asset divestment, the upfront receipt and any subsequent payments for the agreement will be reported in Other Operating Income in the Company's financial statements. The transaction does not impact AstraZeneca's financial guidance for 2015, said AZ. ]]> <![CDATA[Oncology leads development in promising gene therapy pipeline]]> https://biospectrumindia.com/features/95/6974/oncology-leads-development-in-promising-gene-therapy-pipeline.html https://biospectrumindia.com/features/95/6974/oncology-leads-development-in-promising-gene-therapy-pipeline.html Wed, 07 Oct 2015 13:10:47 +0530 However, the majority of these remain in early steps of development, with 76% at either the discovery or preclinical stage, according to business intelligence provider GBI Research. The company's latest report states that oncology, infectious diseases, genetic disorders, cardiovascular diseases and ophthalmological indications are the most active pipeline sectors, as well as the most widely studied in terms of the number of clinical trials. There are 266 pipeline gene therapies in active development for oncology, more than double that of central nervous system disorders, which is the second-largest therapy area. Furthermore, oncology also accounted for 64% of gene therapy clinical trials between 1989 and 2012. Mr Dominic Trewartha, managing analyst, GBI Research, says: "Oncology is the predominant area for gene therapy developments due to its high prevalence and genetically driven pathophysiology. "One reason for the large overall pipeline is the potential for these therapies to develop strong drugs by targeting diseases on a genetic level. Although no products have yet fulfilled this promise, developers expect this in the future." Based on pipeline activity, Isis Pharmaceuticals is a major player in the gene therapy research and development space, with 31 gene silencing-based programs in development across the key therapy areas. Sarepta and Alnylam Pharmaceuticals are also key players, with 25 and 24 pipeline products in development, respectively. Mr Trewartha explains: "In the next decade, these late-stage pipeline developments may translate into clinically and commercially successful gene therapies entering the market. However, high pipeline failure rates due to challenges in developing safe and efficient delivery vectors will remain a barrier. "Other potential obstacles to gene therapy development include difficulties in manufacturing and purifying viral vectors, as well as increased regulatory oversight by the US Food and Drug Administration and general caution from worldwide regulatory bodies following previous trial deaths," concludes the analyst. ]]> <![CDATA[BPH treatment market value to reach nearly $5 bn by 2024]]> https://biospectrumindia.com/features/95/7603/bph-treatment-market-value-to-reach-nearly-5-bn-by-2024.html https://biospectrumindia.com/features/95/7603/bph-treatment-market-value-to-reach-nearly-5-bn-by-2024.html Wed, 07 Oct 2015 13:10:07 +0530 According to research and consulting firm, GlobalData, the seven major markets of the US, France, Germany, Italy, Spain, the UK, and Japan, the US will continue its current dominance, accounting for 65% of the global arena by 2024. Dr Valentina Gburcik, GlobalData's director of cardiovascular & metabolic disorders, states that three novel therapies will contribute to the growth of the BPH therapeutics market, including the launch of Nymox's novel first-in-class therapy, NX-1207, in the US and Europe in 2017 and 2019, respectively. She says: "NX-1207 is a direct prostatic injection indicated for patients with moderate-to-severe BPH. It offers an increased safety profile and improved efficacy in comparison with currently available BPH therapies, and lasts for a mean duration of 3.5 years after a single injection. "The drug will also be priced at a premium compared with current products, meaning that it will contribute significantly towards the anticipated market expansion following its launch." She adds that an increasing number of diagnosed BPH cases worldwide, resulting from an aging male population, will further drive the market over the forecast period. However, several barriers will hinder any further growth in the BPH therapy space. Dr Gburcik explains: "By the end of 2024, various key BPH treatments, such as Jalyn, Avodart, Rapaflo and Cialis, will see their patents expire, followed by subsequent generic erosion. "This will be exacerbated by a lack of pipeline therapies for mild-to-moderate BPH symptoms, leaving a significant portion of the patient population underserved," she concludes. ]]> <![CDATA[Sun Pharma announces Absorica patent litigation settlement]]> https://biospectrumindia.com/news/95/7529/sun-pharma-announces-absorica-patent-litigation-settlement.html https://biospectrumindia.com/news/95/7529/sun-pharma-announces-absorica-patent-litigation-settlement.html Tue, 06 Oct 2015 17:09:01 +0530 Sun Pharmaceutical has announced that Ranbaxy Pharmaceuticals, a wholly-owned subsidiary, along with its partners, Cipher Pharmaceuticals (Cipher) and Galephar Pharmaceutical Research, have entered into a Settlement Agreement with Actavis that dismisses the patent litigation suit relating to Actavis' Abbreviated New Drug Application (ANDA) for a generic version of Absorica (isotretinoin capsules). As part of the Settlement Agreement, Ranbaxy, Cipher, and Galephar have entered into a non-exclusive license agreement with Actavis under which Actavis may begin selling its generic version of Absorica in the US on December 27, 2020 (approximately nine months prior to the expiration of the patents in September 2021) or earlier under certain circumstances. The other terms of the agreement are confidential. The Settlement Agreement is subject to review by the US Federal Trade Commission and the US Department of Justice. ]]> <![CDATA[Thanks to DBT, Indian students could soon be carrying microscopes in pockets]]> https://biospectrumindia.com/news/95/6632/thanks-to-dbt-indian-students-could-soon-be-carrying-microscopes-in-pockets.html https://biospectrumindia.com/news/95/6632/thanks-to-dbt-indian-students-could-soon-be-carrying-microscopes-in-pockets.html Tue, 06 Oct 2015 12:43:12 +0530 Undergraduate students from all parts of the country will soon be able to take a peek through a microscope that they can carry with them, following an initiative by the DBT to reach the Prakash Lab's low cost paper folding-microscope, the Foldscope to students in our country. The letter of intent to distribute Foldscope through DBT's star college and other programmes was exchanged between the DBT and the Prakash Lab in the presence of Prime Minister, Mr Narendra Modi during his visit to Silicon Valley in USA recently. The 'Foldscope' has been developed by Dr Manu Prakash, an Indian-origin Assistant Professor at Stanford University. It all started with a tweet from secretary, DBT, Dr K Vijay Raghavan to Dr Prakash on August 12, 2015. 'Hi, can we discuss using Foldscope widely in India? I am at the Deptt of Biotech, Govt of India," Dr Raghavan had tweeted. Dr Prakash responded immediately welcoming it, a skype call followed subsequently. Prime Minister's office also responded enthusiastically to the call requesting for his support. Rapid communication through the social media played a crucial role quickly paving the pathway for the letter of intent to spread the low technology widely through DBT's network. This was a unique demonstration of how the government is using the social media in novel ways to stimulate citizen science. Dr Prakash is excited about engaging through DBT to extend further the Foldscope's reach to all parts of India. He said, "Our vision is to bring a microscope into the hands of every single kid in the world". "Partnering with Prakash Lab's Foldscope is an exciting new adventure for the Department of Biotechnology. It is Citizen Science at its best. The Foldscope is torchlight in the hands of human curiosity that allows each and every one of us to explore our planet at the microscopic level, just as the telescope allows us to explore the stars. The beauty we see and the science underneath it will create a new generation of young scientists in India. We look forward to taking this wonderful partnership ahead" said Dr Vijay Raghavan.Prakash Lab, a research group at Stanford University working in the field of engineering and physical biology, will source Foldscope to DBT and its constituents. The DBT says it will ensure that the Foldscope is provided to students of the Star College scheme in each identified college. This will be done progressively based on the availability of Foldscope. Foldscope will be used as an educational and training tool to understand physics, chemistry, biology and instrumentation. It will be provided as a kit where the student starts by first building the actual unit from the kit; and explores curiosity driven questions surrounding the microscopic world in physics, chemistry and biology. The users build an online community and share insights, projects, questions and scientific discoveries with the community at Foldscope online platform. Workshops and training programmes will be run by Prakash Lab in collaboration with Indian institutions. The nascent Local Foldscope community based in India will also be involved in training. After this initial pilot program, the collaboration with Prakash Lab will be expanded to setting up of joint research for explorations of other low cost instrumentation in colleges as deemed mutually appropriate. This was a case of matching of views that is focused to create a spark. The Prime Minister has been stressing on using Indian experts abroad to bring benefits to India. ]]> <![CDATA[India, Germany to set up Centers of Excellence in Agriculture]]> https://biospectrumindia.com/news/95/3791/india-germany-to-set-up-centers-of-excellence-in-agriculture.html https://biospectrumindia.com/news/95/3791/india-germany-to-set-up-centers-of-excellence-in-agriculture.html Tue, 06 Oct 2015 11:54:12 +0530 The German Agribusiness Alliance (GAA) and Agriculture Skill Council of India (ASCI) has signed a Memorandum of Understanding (MoU) in a meeting between the Agriculture Ministers from the two countries Mr Christian Schmidt from Germany and Mr Radha Mohan Singh from India, in order to cooperate with each other for the purpose of jointly developing the establishment of "Indo-German Centers of Excellence in Agriculture" aimed at creating a Platform for practical skill development in agriculture in India. The inclusion, participation and funding from the German private sector shall be coordinated by the German Agribusiness Alliance. The centre of excellence will cover four major areas such crop production (including agricultural machinery/mechanization and postharvest handling) and marketing, horticulture crops management, production and value chain integration, cattle breeding / milk production, procurement and marketing and poultry/egg production. Mr Joerg Rehbein, spokesman for the German Agribusiness Alliance said, "The prime objective of this collaboration would be to provide practical professional skill training as well as practical demonstrations of modern technologies and methods (capacity building) to various stakeholders of the agriculture development ecosystem." He further added, "With this initiative, we hope to raise awareness on emerging areas of agriculture technologies and their application, and to adopt best skill development practices and concepts from India and Germany." Mr Sanjeev Asthana, chairman, ASCI said, "The proposed Indo-German Centers of Excellence in Agriculture shall provide both short and long-term practical, professional skill training on modern technologies and methods, and organize demonstrations of technological advancements. The activities would target to reach farmers as well as farm workers and wageworkers in agriculture related industries. In addition, the project shall be used to train trainers of certified private or state training providers and facilities. The Centers shall cover different areas of agriculture and shall be set up in co-operation with agriculture institutions". ]]> <![CDATA[Nobel Prize 2015 in medicine shared by three bioscientists ]]> https://biospectrumindia.com/news/95/5814/nobel-prize-2015-in-medicine-shared-by-three-bioscientists-.html https://biospectrumindia.com/news/95/5814/nobel-prize-2015-in-medicine-shared-by-three-bioscientists-.html Mon, 05 Oct 2015 21:37:23 +0530 This year's Nobel Laureates have developed therapies that have revolutionized the treatment of some of the most devastating parasitic diseases. Dr William C. Campbell and Dr Satoshi ÅŒmura discovered a new drug, Avermectin, the derivatives of which have radically lowered the incidence of River Blindness and Lymphatic Filariasis, as well as showing efficacy against an expanding number of other parasitic diseases. At the same time, Dr Youyou Tu discovered Artemisinin, a drug that has significantly reduced the mortality rates for patients suffering from Malaria. These two discoveries have provided humankind with powerful new means to combat these debilitating diseases that affect hundreds of millions of people annually. The consequences in terms of improved human health and reduced suffering are immeasurable. The discoveries of Avermectin and Artemisinin have revolutionized therapy for patients suffering from devastating parasitic diseases. Therefore, it is beyond any doubt that Dr Campbell, Dr ÅŒmura and Dr Tu have transformed the treatment of parasitic diseases. Rightly so, the Nobel Prize 2015 jury decided to honor them with the Nobel Prize 2015 in physiology or medicine for doing amazing work that will have tremendous benefits for millions. After decades of limited progress in developing durable therapies for parasitic diseases, the discoveries by this year's Laureates radically changed the situation. Satoshi ÅŒmura, a Japanese microbiologist and expert in isolating natural products, focused on a group of bacteria, Streptomyces, which lives in the soil and was known to produce a plethora of agents with antibacterial activities (including Streptomycin discovered by Selman Waksman, Nobel Prize 1952). Equipped with extraordinary skills in developing unique methods for large-scale culturing and characterization of these bacteria, ÅŒmura isolated new strains of Streptomyces from soil samples and successfully cultured them in the laboratory. From many thousand different cultures, he selected about 50 of the most promising, with the intent that they would be further analyzed for their activity against harmful microorganisms. William C. Campbell, an expert in parasite biology working in the USA, acquired ÅŒmura's Streptomyces cultures and explored their efficacy. Campbell showed that a component from one of the cultures was remarkably efficient against parasites in domestic and farm animals. The bioactive agent was purified and named Avermectin, which was subsequently chemically modified to a more effective compound called Ivermectin. Ivermectin was later tested in humans with parasitic infections and effectively killed parasite larvae (microfilaria). Collectively, ÅŒmura and Campbell's contributions led to the discovery of a new class of drugs with extraordinary efficacy against parasitic diseases. Malaria was traditionally treated by chloroquine or quinine, but with declining success. By the late 1960s, efforts to eradicate Malaria had failed and the disease was on the rise. At that time, Youyou Tu in China turned to traditional herbal medicine to tackle the challenge of developing novel Malaria therapies. From a large-scale screen of herbal remedies in Malaria-infected animals, an extract from the plant Artemisia annua emerged as an interesting candidate. However, the results were inconsistent, so Tu revisited the ancient literature and discovered clues that guided her in her quest to successfully extract the active component from Artemisia annua. Tu was the first to show that this component, later called Artemisinin, was highly effective against the Malaria parasite, both in infected animals and in humans. Artemisinin represents a new class of antimalarial agents that rapidly kill the Malaria parasites at an early stage of their development, which explains its unprecedented potency in the treatment of severe Malaria. Diseases caused by parasites have plagued humankind for millennia and constitute a major global health problem. In particular, parasitic diseases affect the world's poorest populations and represent a huge barrier to improving human health and wellbeing. The discoveries of Avermectin and Artemisinin have fundamentally changed the treatment of parasitic diseases. Today the Avermectin-derivative Ivermectin is used in all parts of the world that are plagued by parasitic diseases. Ivermectin is highly effective against a range of parasites, has limited side effects and is freely available across the globe. The importance of Ivermectin for improving the health and wellbeing of millions of individuals with River Blindness and Lymphatic Filariasis, primarily in the poorest regions of the world, is immeasurable. Treatment is so successful that these diseases are on the verge of eradication, which would be a major feat in the medical history of humankind. Malaria infects close to 200 million individuals yearly. Artemisinin is used in all Malaria-ridden parts of the world. When used in combination therapy, it is estimated to reduce mortality from Malaria by more than 20 percen overall and by more than 30 percent in children. For Africa alone, this means that more than 100 000 lives are saved each year. ]]> <![CDATA[ICMR to recruit new directors for its 14 institutes]]> https://biospectrumindia.com/news/95/6354/icmr-to-recruit-new-directors-for-its-14-institutes.html https://biospectrumindia.com/news/95/6354/icmr-to-recruit-new-directors-for-its-14-institutes.html Mon, 05 Oct 2015 13:19:40 +0530 The ICMR in supersession of all its previous advertisements for various director level posts, has now invited fresh applications in prescribed format up to October 21, 2015. The same are for the fourteen posts of directors at the Institutes of ICMR, a premier medical research organization under the department of health research (DHR), ministry of health and family welfare, government of India. ICMR deals with health research in various areas in collaboration with national international agencies through its 32 Institutes/Centres including a large number of field stations situated all over the country. The posts are with all India transfer liability under the Council. The Institutes/Centres where the posts of director are located include: 1. National Centre for Disease Informatics and Research (NCDIR), Bengaluru 2. National Institute of Occupational Health(NIOH), Ahmedabad 3. National Institute of Immunohaematology (NIIH), Mumbai 4. National Institute of Pathology (NIP), New Delhi 5. National AIDS Research Institute(NARI), Pune 6. National Institute of Cholera & Enteric Diseases (NICED), Kolkata7. National Institute of Nutrition(NIN), Hyderabad 8. Enterovirus Research Centre (ERC), Mumbai 9. National Institute of Research in Environmental Health (NIREH), Bhopal 10. Centre for Research in Medical Entomology (CRME), Madurai 11. Regional Medical Research Centre (RMRC), Dibrugarh 12. Regional Medical Research Centre(RMRC), Bhubaneswar 13. Regional Medical Research Centre, Belgaum 14. National Institute for Research in Tuberculosis, Chennai Each of these institutes has their own set of criteria for the post of director. It is a top research management post and a director is required to provide high level leadership in the formulation of research programmes and projects and in organizing and co-ordinating team work. The full details are given on the ICMR's website. ]]> <![CDATA[Biocon acquires Acacia's API manufacturing unit]]> https://biospectrumindia.com/news/95/7038/biocon-acquires-acacias-api-manufacturing-unit.html https://biospectrumindia.com/news/95/7038/biocon-acquires-acacias-api-manufacturing-unit.html Mon, 05 Oct 2015 13:09:08 +0530 The acquisition is said to be effective from October 1, 2015. The unit is involved in manufacturing advanced intermediates of potent APIs (Active Pharmaceutical Ingredients). The financials of the transaction were undisclosed. According to Biocon, the facility measures 45,000 sq ft, and spread across 7 acres. The manufacturing facility's production areas is divided into Block I and Block II, measuring 22,600 sq ft and 22,065 sq ft respectively. The plant's utilities & other areas measure 15,616 sq ft. Biocon on October 1, 2015 posted 4 Tweets on its official Twitter account on the deal. "Acquisition of USFDA-approved facility advantageous for scaling up Biocon's activities as compared to setting up new facility. "Biocon sees synergies in API sales from facility to third parties and company's ANDA business, especially for oncology products," the Tweets read. Through this deal, Biocon intends to vertically integrate oncology-related ANDA filings in future. The purchased plant is said to have been commissioned in 2008. Established in May 2006, Acacia was founded by Mr Gopi Katamaneni, a mechanical engineer. Other promoters of Acacia include Mr Narendra Dodla, Dr N Sreenivasan, Mr Srinivasa Murthy U, and Dr Vijai Pasupuleti. On October 5, 2015, at 12:52 PM, shares of Biocon were trading at Rs 451.80, up Rs 4.2 or 0.94 percent, on the Bombay Stock Exchange (BSE). ]]> <![CDATA[ICRISAT DG urges more research collaborations in pulses]]> https://biospectrumindia.com/news/95/8317/icrisat-dg-urges-more-research-collaborations-in-pulses.html https://biospectrumindia.com/news/95/8317/icrisat-dg-urges-more-research-collaborations-in-pulses.html Mon, 05 Oct 2015 12:50:53 +0530 During his recent trip to the Indian Institute of Pulses Research (IIPR), Kanpur which is an Indian Council of Agricultural Research (ICAR) institute, Dr David J. Bergvinson, DG, ICRISAT, Hyderbad lauded the role of IIPR-ICRISAT collaborative research programmes. Dr Bergvinson was highly appreciative of the research efforts, infrastructure and scientific strengths of the institute and desired to have more such fruitful collaborations in future. He also visited institute facilities and the experimental fields and interacted with scientists regarding experiments and ongoing research programmes. During his visit on September 25, 2015, DG of ICRISAT also participated in the closing ceremony of the 21 days' summer school on "Novel Genomic Tools and Modern Breeding Approaches for Enhancing Productivity and Nutritional Quality of Pulse Crops" and exhorted the audience to strive more for global food and nutritional security. Dr N P Singh, director, IIPR presented a brief about the Institute and explained various activities as well as significant achievements including those on the ICAR-IIPR-ICRISAT collaborative projects. Dr B B Singh, assistant director general (Oilseeds and Pulses), ICAR; Dr Rajeev Varshney, research programme director, Grain Legumes, ICRISAT, Dr N P Singh, director, ICAR-IIPR and Dr K C Bansal, director, ICAR-NBPGR were also present on the occasion. ]]> <![CDATA[Vyome presents research data on novel antibiotics to ASM]]> https://biospectrumindia.com/news/95/5184/vyome-presents-research-data-on-novel-antibiotics-to-asm.html https://biospectrumindia.com/news/95/5184/vyome-presents-research-data-on-novel-antibiotics-to-asm.html Thu, 01 Oct 2015 15:05:08 +0530 Vyome is involved in the development of next generation antibiotics and antifungal agents that target antimicrobial resistance for opportunist pathogens of the skin. The results, in the form of three important studies, describing its DART (Dual Action Rational Therapeutics) antibiotics and clinical results from its antifungal Molecular Replacement Therapy (MRT) technology platform, were presented at the American Society of Microbiology Interscience Conference of Antimicrobial Agents and Chemotherapy (ASM - ICAAC) in San Diego, California, USA. In the first study, Vyome scientists characterized the skin microbiome of acne patients where the study showed the presence of antibiotic-resistant bacteria Propionibacterium acne and Staphylococcus epidermidis in the acne lesions. The study identified the mutations that lead to resistance against the currently used antibiotics, and highlights the need to personalize acne treatment by selecting the right antibiotic to kill the bacteria. Vyome has its lead program VB1953, a novel drug targeting antibiotics resistant acne market of USD 3 Bn, for which IND (Investigational New Drug) application will be filed with the USFDA in Q4 2015. Vyome also presented data on a novel antibiotic based on its patented Dual Action Rational Therapeutics (DART) technology. Compared with other antibiotics, like ciprofloxacin, DART antibiotics are unique in their ability to resist the development of resistance. The new antibiotic exhibits potent activity against antibiotics-resistant Propionibacterium acne and other bacteria. The scientists presented a mechanistic understanding of its unique action at the ASM-ICAAC. "Vyome has a deep pipeline of DART molecules which are in pre-clinical stage. This is very interesting and creative science with far reaching benefits to address antibiotic resistance problem in the USD 50 BN antibiotic market," said Dr Raghunath Mashelkar, chairman, Vyome Biosciences. Vyome has also developed a novel antifungal agent, Procaprycin, based on its Molecular Replacement Therapy (MRT) platform, which replaces an essential fatty acid in the fungus and causes membrane disruption. Malassezia, a skin commensal fungus, is associated with several chronic diseases, including seborrheic dermatitis. Vyome scientists have developed MRT platform technology with Procaprycin using the functional genomic information on Malassezia. The study presented at the ASM-ICAAC meeting highlighted the mechanisms of action and recent clinical data on Procaprycin. "Vyome has two clinically proven products to treat seborrheic dermatitis and dandruff. This is a very novel and effective platform for antifungals and Vyome is currently pursuing commercialization discussions with partners in India and in other countries for different partnership models," says N Venkat, co-founder & CEO, Vyome Biosciences. ]]> <![CDATA[GSK Pharmaceuticals completes transaction with Novartis ]]> https://biospectrumindia.com/news/95/8098/gsk-pharmaceuticals-completes-transaction-with-novartis-.html https://biospectrumindia.com/news/95/8098/gsk-pharmaceuticals-completes-transaction-with-novartis-.html Thu, 01 Oct 2015 12:32:23 +0530 GlaxoSmithKline Pharmaceuticals ('GSK India') announces completion of its transaction with Novartis Healthcare ('Novartis India'), where GSK India acquires Novartis' vaccines business and divests its marketed oncology portfolio to Novartis India. This follows a global transaction between GlaxoSmithKline plc, UK (GSK) and Novartis AG, Switzerland (Novartis) which was completed in March 2015 on the same basis. The acquisition of the vaccines business of Novartis provides GSK with an exciting opportunity to build an even stronger, sustainable global vaccines business. The transaction will enhance GSK's vaccines portfolio and bring together its expertise in virology, bacterial infection and technological platforms to deliver a reliable supply of high quality vaccines. ]]> <![CDATA[Linux for drugs]]> https://biospectrumindia.com/news/95/4035/linux-for-drugs.html https://biospectrumindia.com/news/95/4035/linux-for-drugs.html Wed, 30 Sep 2015 13:24:00 +0530 Held at Castle Rauischholzhausen in Germany, the OSP conference brought together researchers, NGOs, industry professionals, philanthropists and entrepreneurs who aim to create better, cheaper, and faster ways to bring novel therapeutics to market. Open Source Pharma (OSP) is a concept inspired by the Linux model of operation. In brief, crowdsourced, computer-driven drug discovery; IT-enabled clinical trials with open data; and generics manufacture. In four words, Open Source Pharma is "affordable medicine for all." In three words it is,"Linux for drugs." Adapted to tackling important public health challenges, it hopes to catalyze radical change in the way we do medical R&D and deliver better and more affordable innovation quicker and cheaper to patients. This year's conference was a follow-up to the first global Open Source Pharma Conference, held at the Rockefeller Foundation Bellagio Center, Lake Como, Italy in 2014, where participants adopted a joint mission statement for the movement. In addition to Tata Trusts, the conference included participants from MÃ©decins Sans FrontiÃ¨res, Open Source Drug Discovery (OSDD), Sanofi Aventis, Open Source Malaria, the Open Society Foundations, the Structural Genomics Consortium, INSERM, Oxford University, Philipps-University Marburg, Paris Descartes University, McGill University, FasterCures - a center of the Milken Institute, Transparency Life Sciences, Taros Chemicals, Center for Research and Interdisciplinarity (CRI), Germany's House of Pharma, Gesmer Updegrove LLP, Cures within Reach, Medicines for Malaria Venture, and the Foundation for Neglected Disease Research, and has previously included participants from the WHO/TDR, other large pharmaceutical companies, and several national governments. Mr Jaykumar Menon, convener, Open Source Pharma Foundation, said, "Our vision is to provide affordable medicine for all. We aim to support a growing open source pharma movement that includes existing initiatives to create a comprehensive and alternative open source pharmaceutical system driven by principles of openness, patient need, and affordability. It will systematically address bottlenecks in the pharmaceutical development pipeline by applying open source techniques wherever applicable. This covers all stages, from policy or political will to discovery, development, manufacturing, distribution, and use. Open Source Pharma bends the energies of the universe towards bugs that affect billions. With enough eyes, all bugs are shallow." In India, the Open Source Pharma Foundation's initial projects include India's first Product Development Partnership (PDP), led by Dr Tanjore Balganesh, the former head of Astra Zeneca India, and will focus on the rapid development of breakthrough medicines, including renewed efforts to develop effective therapies to roll back the tuberculosis epidemic, which kills nearly 1.5 million patients a year, making it the most lethal infectious disease globally after HIV/AIDS. Other activities include public outreach, education initiatives including open source research fellowships, and global crowdsourced science. Advisory Board members include Bernard Munos (FasterCures/Forbes blogger), Matthew Todd (The University of Sydney/Founder of Open Source Malaria). Mr Ganesh Neelam, development manager, Tata Trusts said, "Tata Trusts shares the vision to deliver affordable medicines for patients across the world and especially in developing countries. We are confident that within five years, our co-partnership with the Open Source Pharma Foundation will enable innovative breakthroughs in cost-effectively treating the most pressing diseases such as tuberculosis and malaria. We have been one of the first supporters of this initiative and are fully committed to making a real difference in this area." Tata Trusts are amongst India's oldest, non-sectarian philanthropic organizations. Tata Trusts seek to be catalysts in development through giving grants to institutions in the areas of Natural Resources Management, Rural Livelihoods, Urban Livelihoods & Poverty, Education, Enhancing Civil Society and Governance, Health, and Media Arts, Crafts and Culture. ]]> <![CDATA[Dr. Srinivasa Reddy of CSIR-NCL bags the prestigious Shanti Swarup Bhatnagar Prize ]]> https://biospectrumindia.com/news/95/4691/dr-srinivasa-reddy-of-csir-ncl-bags-the-prestigious-shanti-swarup-bhatnagar-prize-.html https://biospectrumindia.com/news/95/4691/dr-srinivasa-reddy-of-csir-ncl-bags-the-prestigious-shanti-swarup-bhatnagar-prize-.html Wed, 30 Sep 2015 10:33:10 +0530 The Shanti Swarup Bhatnagar Prize for the year 2015 in chemical sciences has been awarded to Dr. D. Srinivasa Reddy of CSIR-National Chemical Laboratory (CSIR-NCL), Pune for his outstanding contributions to the area of total synthesis of natural products and medicinal chemistry. This is a most prestigious award given to the scientists under 45 years of age and who have demonstrated exceptional potential in Science and Technology. The award derives its value from its rich legacy of those who won this award before and added enormous value to Indian Science. Dr. Reddy will be bestowed with the award at a formal function, which shall be presided over by the honourable Prime Minister. The award, named after the founder director general of Council of Scientific & Industrial Research (CSIR), Dr. Shanti Swarup Bhatnagar, comprises a citation, a plaque, a cash prize of Rs 5 lakh. Dr. Reddy's research group current interests are in the field of total synthesis and drug discovery by applying medicinal chemistry. He has also been involved in the synthesis of the agrochemicals like small molecules for crop protection. The total synthesis of more than twenty natural products has been achieved in his lab including a sex pheromone that attracts the mealy bugs and has potential use in the crop protection. On the medicinal chemistry front significant progress has been made by his group using a new concept called "Silicon-switch approach" towards central nervous system drugs. Identification of New Chemical Entities for the potential treatment of diabetes and infectious diseases is being done in collaboration with industry partners. His efforts are evidenced by 65 publications and 30 patents. He has recently received the NASI-Reliance industries platinum jubilee award-2015 for application oriented innovations and the CRSI bronze medal. In addition, he is also the recipient of Central Drug Research Institute award for excellence in the drug research in chemical sciences and scientist of the year award by the NCL Research Foundation in the year 2013. Dr. Reddy had worked with pharmaceutical companies for seven years before joining CSIR-NCL in 2010. ]]> <![CDATA[World Heart Day: WHO calls countries for action to reduce CVDs in women]]> https://biospectrumindia.com/news/95/6013/world-heart-day-who-calls-countries-for-action-to-reduce-cvds-in-women.html https://biospectrumindia.com/news/95/6013/world-heart-day-who-calls-countries-for-action-to-reduce-cvds-in-women.html Tue, 29 Sep 2015 14:46:14 +0530 Cardiovascular diseases (CVDs), including heart disease and stroke, are the world's number one killers, claiming 17.5 million lives a year globally. In the WHO South-East Asia Region, cardiovascular diseases cause an estimated 3.7 million deaths annually, one fourth of all deaths. One third of these deaths from cardiovascular diseases is premature and occurs among those aged less than 70 years. "The majority of premature deaths due to cardiovascular disease can be prevented through simple measures such as consuming a healthy diet, engaging in regular physical activity, avoiding tobacco and alcohol, and by managing stress," said Dr Poonam Khetrapal Singh, WHO regional director for South-East Asia. The theme for World Heart Day this year is - 'Healthy heart choices for everyone, everywhere'. "This is a reminder of the impact that our environments can have on our ability to make the best choice for a healthy heart. It is a call to all sectors of government and society to create heart-healthy environments and provide heart-healthy choices for all individuals, where they live, work and play," Dr Poonam pointed. Examples of heart-healthy environments include the availability of healthy food, smoke-free zones and avenues for physical activity. Such heart-healthy choices can be provided in public spaces, schools, workplaces and communities. Dr Poonam stressed that on countries to take action to reduce heart disease in women. Cardiovascular diseases are a major health problem among women and remain under-recognized and under-treated. Risk factors for heart disease in women mirror those in men and include lifestyle factors such as tobacco use, overweight and obesity, harmful alcohol use and physical inactivity, as well as physiological risk factors such as elevated blood pressure, high cholesterol and diabetes mellitus. "Additionally, in the South-East Asia Region, exposure to household air pollution from using solid fuels for cooking substantially increases the risk of heart disease in women," she noted. She feels that cohesive action and collaboration are needed beyond the health sector to provide a heart-healthy environment and heart-healthy choices for women to reduce their risk of cardiovascular disease. "Health-care providers should also be alert in recognizing and managing cardiovascular disease risk in women," Dr Poonam stated. The WHO Region for South-East Asia has set a target for reducing premature mortality from cardiovascular disease and other noncommunicable diseases (NCDs) by 25 percent by 2025 and has developed a regional action plan to achieve this target. "The inclusion of NCDs in the post-2015 agenda for sustainable development is a turning point, and should add further momentum in reducing the burden of cardiovascular diseases and other NCDs," Dr Poonam ended. ]]> <![CDATA[The Philips Foundation partners with UNICEF ]]> https://biospectrumindia.com/news/95/6439/the-philips-foundation-partners-with-unicef-.html https://biospectrumindia.com/news/95/6439/the-philips-foundation-partners-with-unicef-.html Tue, 29 Sep 2015 11:28:02 +0530 UNICEF and The Philips Foundation, together with Concern Worldwide, Maker and Gearbox, have launched the Maternal and Newborn Health Innovations Project, to help save lives and improve the health of pregnant women and children in Kenya. Under the leadership of the Government of Kenya and the Project's Steering Committee at the Ministry of Health, UNICEF and The Philips Foundation will facilitate the development of innovative health technology and solutions in the field of maternal, newborn and child health. This cooperation will help catalyze novel health interventions for the benefit of the most vulnerable mothers and children, and contribute to reducing the number of deaths of pregnant women and their newborn babies. This investment is in keeping with the Government of Kenya's commitment to investing in innovative, home-grown solutions for maternal and newborn health care. In developing countries such as Kenya, maternal, newborn and child mortality rates remain unacceptably high. By 2018, UNICEF and The Philips Foundation, together with partner organizations and local innovation hubs with guidance from the Government of Kenya, aim to develop and scale up innovative, low-cost and locally designed health care devices. These will contribute to improved and more equitable access to life-saving quality care for women and children across Kenya. "For 1 million babies worldwide every year, their day of birth is also their day of death," said Mr Sharad Sapra, UNICEF Director of theâ€¯UNICEFâ€¯Global Innovation Centre. He added, "But with strengthened health systems and innovative solutions for both mothers and children, the chance for survival is greatly increased." The Maternal and Newborn Health Innovations Project is financed by The Philips Foundation and uses the local expertise of Philips Research Africa in Nairobi to mentor social entrepreneurs and facilitate the transfer of health care technology know-how in Kenya. "At The Philips Foundation, it is our belief that programmes that combine innovation, partnerships and empowering people will make a lasting and meaningful difference in communities," said Ms Katy Hartley, Head of The Philips Foundation. She added, "In the case of the Maternal and Newborn Health Innovations Project, we are doing just that, as Royal Philips can offer expertise and support from its Philips Research Africa, together with UNICEF and our implementation partners, to enable social entrepreneurs to improve health outcomes for their own communities." The project was launched ahead of the September 25-27 United Nations Summit for the Adoption of the Post-2015 Development Agenda, where UNICEF is promoting greater involvement of the private sector in improving children's lives. ]]> <![CDATA[Dr Reddy's launch new generic in the US ]]> https://biospectrumindia.com/news/95/6266/dr-reddys-launch-new-generic-in-the-us-.html https://biospectrumindia.com/news/95/6266/dr-reddys-launch-new-generic-in-the-us-.html Tue, 29 Sep 2015 11:23:34 +0530 Dr Reddy's Laboratories has announced that it has launched ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE CAPSULES USP, 20 mg and 40 mg in the US market, following the approval by the United States Food and Drug Administration (US FDA). The drug is a therapeutic equivalent generic version of Astrazeneca's NEXIUM (esomeprazole magnesium) used to treat acid reflux. The NEXIUM (esomeprazole magnesium) Delayed-Release Capsules brand and generic had the US sales of approximately $5.2 billion MAT for the most recent twelve months ending in July 2015, according to IMS Health. Dr Reddy's ESOMEPRAZOLE MAGNESIUM DELAYED-RELEASE CAPSULES USP, 20 mg and 40 mg are available in bottle count size of 30. ]]> <![CDATA[National strategy needed for rabies elimination: WHO]]> https://biospectrumindia.com/news/95/6440/national-strategy-needed-for-rabies-elimination-who.html https://biospectrumindia.com/news/95/6440/national-strategy-needed-for-rabies-elimination-who.html Mon, 28 Sep 2015 15:52:24 +0530 Over 1.5 billion people in the Region are at risk of rabies infection. Every year an estimated 4 million people take rabies preventive vaccines, mostly after dog bites. About 40% people exposed to dog bites are children in the age group of 5 to 15 years. As of today, rabies has no cure. "Eliminating rabies is an important public health goal. National strategies are needed for rabies elimination with the focus on increasing public awareness and making cost-effective post-exposure vaccination available to all. Ensuring post-exposure rabies vaccination is available to all in an equitable manner, should be a key element of rabies elimination efforts," pointed Dr Poonam Khetrapal Singh, regional director, WHO South-East Asia Region. Communities have an important role to play in rabies elimination. Dr Singh added, Simple but important measures such as vaccinating pet dogs and cats against rabies, thoroughly washing dog bite wounds with soap and water, and taking rabies vaccination when exposed to bite of a rabid or suspected animal, will strengthen rabies elimination efforts." WHO is now working together with Food and Agriculture Organization (FAO) of the United Nations (UN), World Organization for Animal Health (WOAH) and animal welfare organizations to implement a comprehensive rabies elimination programme in rabies endemic countries. Bangladesh, Bhutan, Sri Lanka and Thailand are already witnessing a decline in human rabies death after implementing mass dog vaccination campaigns in combination with dog population management and improving accessibility to post-exposure vaccination. The World Rabies Day this year focuses on making the elimination goal, set for 2020 in the WHO South-East Asia Region, a reality. ]]> <![CDATA[â€œAIIMS has set a benchmark in excellence in healthcareâ€?]]> https://biospectrumindia.com/news/95/4315/aiims-has-set-a-benchmark-in-excellence-in-healthcare.html https://biospectrumindia.com/news/95/4315/aiims-has-set-a-benchmark-in-excellence-in-healthcare.html Mon, 28 Sep 2015 13:17:00 +0530 Government is committed to ensuring that the new AIIMS will meet the same standards of service as AIIMS, New Delhi. No effort will be spared to make them the very best, he added. Minister stated that AIIMS has created a benchmark in the field of healthcare not only at the national level but internationally also. It has a great testimony and we must try to replicate it in the new 15 AIIMS. This was stated by Mr J P Nadda, union minister for health and family welfare recently at New Delhi. The minister has made it clear that the new institutes will be "AIIMS" and not "AIIMS-like". He was speaking at the 60th Institute Day Celebrations of All India Institute of Medical Sciences (AIIMS), in New Delhi on September 24, 2015. He also inaugurated a public health exhibition dedicated to the theme "Be Clean-Be Healthy" and launched the logo for the Diamond Jubilee Celebrations of AIIMS on this occasion. Mr Nadda said that the Government has extended all support for the major expansion programs of AIIMS with a new Mother and Child Block, an OPD Block and a National Cancer Institute. Proposals for expansion of the Trauma Centre and Development of Western Campus of AIIMS are also underway, he informed. These expansion plans would fulfil the long felt needs of the apex medical institution in the country, he stated. The minister congratulated all the former directors who have made AIIMS what it is today. AIIMS has discharged its roles as clinical provider, research institute and teaching institution with considerable accolades over the past six decades. AIIMS, Delhi has always maintained the highest standards of meritocracy and learning and it has attracted the best talents across the country, he added. Mr Nadda appreciated the theme of the exhibition "Be Clean, Be Healthy" and stated that the theme explained the salient features of "Kayakalp", a scheme which was recently launched by the health ministry for promoting and encouraging sanitation and cleanliness in hospitals. He informed that the institute has done considerable progress under the "Clean and Green AIIMS" campaign launched in July this year. The health minister also gave away the AIIMS Excellence and Research Awards, 2014-15 for basic and clinical sciences and congratulated the awardees. Prof M C Misra, director AIIMS, Prof S K Acharya, dean-Research, Prof Balram Airan dean-Academic, Prof O P Kharbanda, chief CMET, chiefs of centres, faculty members, and senior residents of the institute. Also present was Prof S Rajasabapathy of Ganga Medical Centre and Hospitals, Coimbatore who delivered the 21st AIIMS Silver Jubilee Oration speech. ]]> <![CDATA[CSIR should mobilize its potential in a structured manner: Dr Harsh Vardhan]]> https://biospectrumindia.com/news/95/7551/csir-should-mobilize-its-potential-in-a-structured-manner-dr-harsh-vardhan.html https://biospectrumindia.com/news/95/7551/csir-should-mobilize-its-potential-in-a-structured-manner-dr-harsh-vardhan.html Mon, 28 Sep 2015 13:03:13 +0530 There is a greater need for synergy for research activities as similar activities are going on at various places without these participants knowing about it. He called for introspection to set things right. The union minister of science and technology and vice president, CSIR, Dr Harsh Vardhan on September 26, on the occasion of CSIR Foundation Day has said that the entire potential of CSIR should now be mobilized in a structured manner to solve various problems of the country. The minister of state for science and technology, Mr Y S Chowdary lamented that there is a gap between the common man and the scientific community, which "needs to be bridged at the earliest". Science in India is more "scientists centric" rather than "dealing with national priorities" and if the scientific community does not act swiftly, it will "lose trust of people". He said there is possibility for creating technology spinoffs in our country for making it a knowledge economy. Mr Y S Chowdary had also distributed scientifically improved seeds to farmers from various parts of the country. Later Dr Harsh Vardhan as a part of the awards ceremony gave away CSIR Young Scientists awards, G N Ramachandran Gold medals for excellence in Biological Sciences and Technology for 2014 & 2015 and CSIR Technology Awards 2015. Details of Technology Awards are as follows: CSIR-Central Institute of Medicinal and Aromatic Plants (CSIR-CIMAP), Lucknow won the Technology Award for Life Sciences for development of improved varieties and promotion of cultivation of medicinally important Aswagandha for improving the economy of small and marginal farmers in Semi-Arid Tropical (SAT) regions of Deccan Plateau in association with teams at CSIR-NBRI, Lucknow; CSIR-CDRI, Lucknow and CSIR-IICB, Kolkata. The developed Aswagandha varieties coupled with effective extension activities increased the area under cultivation and improved the quality of life of more than 6300 small and marginal farmers (53 clusters in five districts) in the SAT regions of the Deccan plateau by raising their income more than two folds in comparison to the conventional crops. CSIR-National Chemical Laboratory (CSIR-NCL), Pune won the award for Physical Sciences including engineering for developing solid catalyst and continuous process for biodiesel process. CSIR-NCL has developed a greener method for biodiesel production, which employs a proprietary, solid, reusable, acid catalyst and a continuous fixed-bed process. Unlike the conventional method, CSIR-NCL process converts a variety of inedible oils and animal fat into biodiesel in high yields and greater selectivity. The process has been licensed to Benefuel Inc., USA. CSIR recognizes the contribution of Benefuel Inc., USA for pilot plant erection, operation and commercialization of the technology. CSIR-Central Glass and Ceramic Research Institute (CSIR-CGCRI), Kolkata and CSIR- Central Leather Research Institute (CSIR-CLRI), Chennai have jointly won the award for Innovation. CSIR-Indian Institute of Petroleum (CSIR-IIP), Dehradun and CSIR-National Aerospace Laboratories (CSIR-NAL), Bengaluru have jointly won the award for Most Significant CSIR Technology of the Plan Period. CSIR-National Metallurgical Laboratory (CSIR-NML), Jamshedpur has won the award for significantly enhancing the business and markets for its knowledgebase base. ]]> <![CDATA[Dr Reddy's to buy IP rights of Alchemia's Fondaparinux]]> https://biospectrumindia.com/news/95/4266/dr-reddys-to-buy-ip-rights-of-alchemias-fondaparinux.html https://biospectrumindia.com/news/95/4266/dr-reddys-to-buy-ip-rights-of-alchemias-fondaparinux.html Mon, 28 Sep 2015 12:21:26 +0530 Alchemia, an Australian drug discovery and development company, has announced that it has entered into a binding term sheet for the sale of the worldwide exclusive intellectual property rights to fondaparinux sodium, its generic anti-coagulant drug, to Dr Reddy's Laboratories. Under the binding terms of the sale, Alchemia will receive $17.5 million (approximately AU$24.3 million) in cash from Dr Reddy's upon the closing of the transaction. In addition to the agreed sale consideration, the Company received a payment of $1.15 million for its share of net profit from US-only sales of fondaparinux for the quarter ending 30 June 2015. Should the transaction be approved by shareholders and the transaction subsequently closed, the Company will not be entitled to receive any further profit share revenues from fondaparinux sales. The sale is conditional on shareholder approval, as the sale constitutes a disposal of the Company's main undertaking per the ASX Listing Rules. Shareholder approval is expected to be sought at the Company's upcoming annual general meeting to be held in November this year. The Company is in the process of seeking an independent expert's report to assist shareholders in their decision on how to vote on the transaction. In 2007, Alchemia granted Dr Reddy's non-exclusive rights to the manufacture of fondaparinux sodium in API (Active Pharmaceutical Ingredient) form, and exclusive rights to market fondaparinux in the North America. In exchange for these manufacturing and marketing rights, Alchemia was entitled to receive 50 percent of the net profit generated from sales of fondaparinux in North America. Dr. Reddy's is responsible for finishing of the product, all regulatory filings, and market launch. The Company's generic fondaparinux was approved by the US Food and Drug Administration ("FDA") in July 2011, and launched by Dr. Reddy's in the US shortly after. To date, the Company has received a total of $21.4 million (AU$23.3 million) in revenues from its share of net profits for US sales of fondaparinux. These revenues are net of (after) the Company's contribution of $5.0 million (AU$5.5 million) towards cost of goods improvements. In 2012, the Company granted Dr Reddy's exclusive rights to market fondaparinux in all territories, other than North America, in exchange for an agreed share of the net profits generated from sales in those territories. In addition to the US, fondaparinux is currently being sold in Canada and India, however sales of fondaparinux in these territories are yet to generate any profits. Fondaparinux is yet to be launched in any other territory. ]]> <![CDATA[Pharma regulators concerned over adverse drug reactions]]> https://biospectrumindia.com/news/95/6804/pharma-regulators-concerned-over-adverse-drug-reactions.html https://biospectrumindia.com/news/95/6804/pharma-regulators-concerned-over-adverse-drug-reactions.html Thu, 24 Sep 2015 13:41:46 +0530 In the next 10 years the number of pharma manufacturing units will rise by six times from current level of 12,000 units and it becomes all the more important for India to see that while its drugs manufacturing and their exports registered a manifold increase with no suspicion in their content and quality. This was stated by the secretary, department of pharmaceuticals, ministry of chemicals and fertilizers, Dr V K Subburaj while inaugurating a Conference on 'Pharmacology: R&D for Minimizing ADRs and Role of Pharmacists' under aegis of PHD Chamber of Commerce and Industry on September 23 at New Delhi. Mr Subbaraj pointed out that ADRs (Adverse Drug Reactions) happen due to multiple reasons as variety of stakeholders are involved in drugs administration and therefore, the time has come when India is required to put in a place a sort of regulatory mechanism that can keep an eye to curb the menace of rising ADRs as the tendency that prevails currently is to hush up such cases. "America for example, set out to address this issue way back in 1962, consequently little number of cases of ADRs are reported there though India also awake to this fact in 1982, we have achieved little progress to contain ADRs. This is because it has not been able to create an effective mechanism to address the issue", said Mr Subburaj. According to him, no definite and effective statistics and estimates are available as to how many cases of ADRs happen each year while in America such statistics are accurate and the system in place, India therefore, needs to emulate such a country to address the issue of ADRs with an effective monitoring system in place. Later on speaking on the occasion Drug Controller General of India Dr G N Singh concurred that ADRs is the serious issue and the authorities concerned are in constant touch and consultation process with functionaries of WHO so that protracted deliberations are concluded in which representatives 100 emerging economies assemble here and find out ways and means to evolve a regulatory mechanism to contain the menace of ADRs. On the suggestion by the expert panelists that the pharmacists be allowed to prescribe medicines for ailments of general nature, the DCGI said that the government will view it with an open mind. He also stressed on the suggestion saying Pharm D graduate should be employed at district or sub-taluka level PHCs. He has also given a suggestion to classify the drugs into three categories i.e. the drugs (OTC) which consumer can take directly from medical store, few limited drugs which could be prescribed / suggested by pharmacists and the specialty drugs prescribed by medical doctors. This will also improve the access of healthcare services especially in areas where there is shortage of doctors while the pharmacists are available. NABH guidelines will also now look at including the role of pharmacists for the accreditation said CEO, NABH Dr K K Kalra. Among other who were present on the occasion comprised chairman, health committee, PHD Chamber Mr Nishant V Berlia and its secretary general Mr Saurabh Sanyal. ]]> <![CDATA[Hot Start-up: Disruptive next-gen solutions for food analysis industry]]> https://biospectrumindia.com/features/95/7227/hot-start-up-disruptive-next-gen-solutions-for-food-analysis-industry.html https://biospectrumindia.com/features/95/7227/hot-start-up-disruptive-next-gen-solutions-for-food-analysis-industry.html Thu, 24 Sep 2015 10:50:04 +0530 Melamine is a white, crystalline, organic base chemical rich in nitrogen, widely used in the manufacture of adhesives, plastics and whiteboards. This chemical has the capacity to increase the milk's nitrogen content, leading to an increased protein levels in the milk, which has been excessively adulterated with water. During this time, Dr Venkat's group were developing bioanalysis methods for processing large number of samples within a short duration. These methods were immediately put to use, and an analysis method to rapidly and reliably detect melamine in milk was published. Over the next few years, the team developed an entire analytical tool kit for pesticide and food contaminant analysis was developed. The primary aim was to cater to the unique analysis needs of Indian farmers and exporters, which means handling high-volume perishables. Ultimately, in 2014, NCL alumni from Dr Venkat's group and a couple of other scientists from NCL set-up Barefeet Analytics to commercialize these methods. The start-up intends to leverage the teams' diverse and sound understanding of both scientific and business aspects to provide potentially disruptive solutions for food analysis. The team and the business ideas were nurtured at NCL Venture Center in Pune. Barefeet's current team members include Dr Ajeet Singh (32), Mr Vishal Mahale (25), and Dr Magesh Nandagopal (37). Dr Venkat Panchagnula currently serves as the director of the venture. "We decided to apply for BIRAC's Biotechnology Ignition Grant (BIG) to further develop our proof-of-concept for field trials. Approvals for the start-up through the CSIR's Scientist Entrepreneurship Program were obtained. We put a dedicated team together and rented out lab space at NCL Venture Center to begin operations," says Dr Venkat. The food analysis market in India presents a huge opportunity for the company. Currently, the export markets, for example, in the US or EU, are highly regulated, while the Indian markets are catching up to meet the food safety standards. There is a pressing need in the Indian food industry for efficient analysis of farm and food products. "At every stage of the supply chain, a reliable partner is needed to ensure that products are meeting the required standards, and regulatory specifications among others. This need is being felt more and more now. And we are looking to serve this need," Dr Venkat remarks. There are numerous challenges in the economics and logistics of food analysis with significant rejection rates and losses in the export market. Compliance in the Indian scenario is challenging due to several reasons including the needed scale of operations. Infrastructure Challenges Initially, the company had a major challenge in facing the capital-intensive high-end scientific instrumentation needed to carry out its R&D work. "Fortunately, the facilities available at NCL Venture Center have helped us to manage it in the initial phases," adds Dr Venkat. "We are trying to develop next-generation solutions that would change the face of food analysis industry. We obviously have to get the buy-in from regulators and get our methods accepted. That is one of our prime challenges." The company has received its seed funding through BIRAC's BIG grant worth Rs 47 lakh. "We are also generating some revenues through consultancy and executing small projects in our domain expertise. We are hoping to raise funds in the coming year to help us in setting up a full-fledged food analysis laboratory," Dr Venkat reveals. The start-up now caters to quality control & food testing laboratories, food & beverage processing units, food & produce exporters, farmers, and organized high-value retailers. Partnerships & Collaborations He expresses, "We would love to work with food processors, exporters, and farmers - basically all our customers - in developing specialized solutions for their needs. Also, we are looking for partners from existing analytical labs in India and abroad." The venture initially aims to build and strengthen its crucial capabilities, infrastructure and manpower. He explains, "This involves setting up a food testing and analysis laboratory with the requisite hardware, and being on the path to quality and regulatory certifications. Simultaneously, we'll undertake sales and marketing activities to generate revenues. A key aim would be to gain the credibility among customers. We aim to reach out to strategic partners, both within India and outside, for collaborations, investments, and strategic partnerships, for widened reach to other markets." Networking events, interacting with key opinion leaders and having a good website along with a strong presence on social media are its key strategies in building its brand visibility. Enabling Scientific Enterprises Dr Venkat says that a lot more needs to be done for enabling science-based enterprises in India. He elaborates, "A crucial bottleneck is the infrastructure that is needed at every step. Government-supported scientific R&D including the CSIR should be prodded to open up and help MSMEs, which unfortunately is still a far cry from what it should be. Scientists who are also entrepreneurs should be incentivized, and are still looked at with suspicion by the Establishment." Usually the incubation time for these start-ups are much longer. With insufficient support, not many start-ups will be able to survive for long. "The amount of paperwork at every stage is daunting. For example, to import an equipment from abroad, a license is needed while any common person can buy the same from Amazon. Huge customs duties for these imports heavily burden the start-ups. Beyond the ignition grants, funding avenues for good ideas are few in comparison to the size of our country. Investors in India are either averse to capital heavy investments. Often they lack understanding to offer meaningful support. Further encouraging and easing foreign direct investments (FDIs) in science-based start-ups is also needed," he patiently describes. So far, Barefeet has made good headway in detecting pesticide residues in grape samples. This involves innovation on all fronts - integrating the cutting-edge hardware, developing new analytical methods and data processing capabilities, expresses Dr Venkat. "This augurs well for our impending forays into the milk and honey analysis market and other food products analysis," he mentions. Quicker ROIs Dr Venkat admits that it is tough to explain the dynamics to shareholders and investors who seek quicker returns. "We look for folks who are already in some way tuned to or have exposure to high-technology space, and understand that it is a valuation play and not necessarily a revenue play in the initial years. Even though we have a terrific team, and are fully capable of generating revenues from undertaking analytical services and consulting from day one, we consciously dedicate only a part of our energies to shore up our operating funds," he shares. However, he says that from his observation VCs are indeed funding Life Science start-ups in India. "But the funding comes in at a much later stage. It is particularly in Life Sciences, where technology derisking requires much greater investments. VCs should take the lead and fund during the earlier stages of the start-up," he notes. Synergistic Ecosystem According to him, Pune and Chennai are faring quite well as Life Sciences start-up hubs. "Both these cities have a high density of skilled manpower, critical mass of higher educational or tertiary institutions, research centers of international repute, strategic proximity to vibrant industrial corridors and existing infrastructure," he justifies. He comments that revenue generation is not always essential for raising initial investments abroad, while it is a hard-sell if start-ups were to approach investors in India without revenues. "In the West, opening and closing companies," Dr Venkat emphasizes, "is much easier and the paperwork is a lot lesser. It is easier to find highly-skilled and trained manpower and set-up in a world-class technology incubator, usually close to a University eco-system. Some of these innovation parks offer rent-free space in the initial stages among other such incentives. It is also easy to procure used equipment for labs, at times from e-bay and service them, while such a thing is unthinkable in India. The scale of science-based entrepreneurship happening in the US or UK is phenomenal, and we have a long way before we can catch up." Incubator Support Dr Venkat stresses that all entrepreneurs need the same qualities to begin. "Being market and customer-focused is one of them. There are plenty of other qualities we can talk about. Big institutes like IITs or IIMs come with their extensive alumni networks, and hence could prove advantageous from that front. Otherwise, it is all the same. People with fire will survive, others will... well, move on," he states. He advises start-ups to stick to whatever works for them, whether starting up independently or joining an incubator or accelerator. "Incubators do provide a great deal of support and cushioning for first-time entrepreneurs. They provides a platform where companies can meet and network with other people. Some of them even provide funds for start-ups-all of which are very important," he opines. Billion-Dollar Start-ups Can India raise billion-dollar Life Sciences start-ups? "There is no easy answer to this," says Dr Venkat. "As a society, we have huge tasks at hand on providing quality education, health, food and infrastructure. Scaling these up while achieving quality, leading to productivity and growth is a complex problem. A society that achieves this, mostly the US, has a lot of synergies in place. However, we do have a large enough drive in the form of existing opportunities. For example, there are large gaps in services especially in achieving the last mile connectivity. While the challenges for a start-up are significant. These are motivating enough for keeping the hopes high," he highlights. Dr Venkat says that if not being an entrepreneur, he'd have been quite happy in any role that allows him to innovate, especially if it has societal relevance while retaining a certain amount of independence. "In that sense, the major difference in working for some organization versus being an entrepreneur would be about taking risks," he ends. Quick Bites: Company's Roadmap: ï‚§ Capacity buildingï‚§ Revenue generationï‚§ Strategic partnership Entrepreneurial Lessons Learnt: ï‚§ Cost - Rarely being the only differentiator for a product/serviceï‚§ Importance of quality ]]> <![CDATA[India's generics market to touch $26.1 bn by 2016, IBEF reports]]> https://biospectrumindia.com/reports-white-papers/95/7629/indias-generics-market-to-touch-26-1-bn-by-2016-ibef-reports.html https://biospectrumindia.com/reports-white-papers/95/7629/indias-generics-market-to-touch-26-1-bn-by-2016-ibef-reports.html Wed, 23 Sep 2015 14:46:33 +0530 India's pharmaceutical industry is expected to expand at a CAGR of 14.5 percent over 2009-20 to reach $55 billion, according to a report by India Brand Equity Foundation (IBEF). The Indian healthcare sector, considered as one of the fastest growing sectors, is expected to advance at a CAGR of 17 percent to reach $280 billion over 2011-20. As a major generics market, the country is expected to grow to $26.1 billion by 2016 from $11.3 billion in 2011. India's generics market has immense potential for growth, IBEF said. In terms of biosimilars, India's biosimilars sector is expected to touch $1.4 billion by 2016 from $482 million in 2011. The Indian government plans to allocate $70 million for local players in the country to develop biosimilars. Click here to view or download the full report. ]]> <![CDATA[Pfizer to sell its Thane Plant ]]> https://biospectrumindia.com/news/95/6225/pfizer-to-sell-its-thane-plant-.html https://biospectrumindia.com/news/95/6225/pfizer-to-sell-its-thane-plant-.html Wed, 23 Sep 2015 11:49:10 +0530 Pfizer Ltd has informed BSE that it has entered into a Business Transfer Agreement (BTA) for the transfer of the Company's business at the Thane Plant as a going concern to Vidhi Research and Development, in accordance with the terms of the agreement for a consideration of Rs 178 crore. Upon the conclusion of the BTA, all current workmen at the Thane Plant shall be transferred to the buyer so as to facilitate manufacturing operations, the company added. ]]> <![CDATA[Govt releases health data, calls it a step towards digitization]]> https://biospectrumindia.com/news/95/7167/govt-releases-health-data-calls-it-a-step-towards-digitization.html https://biospectrumindia.com/news/95/7167/govt-releases-health-data-calls-it-a-step-towards-digitization.html Wed, 23 Sep 2015 10:18:55 +0530 The 11th edition of National Health Profile (NHP)-2015 prepared by the Central Bureau of Health Intelligence (CBHI) was released by the union minister for health and family welfare, Mr J P Nadda on September 22, 2015. The E-book (digital version) of the annual document, which has been prepared for the first time, was also released. The National Health Profile covers demographic, socio-economic, health status and health finance indicators, along with comprehensive information on health infrastructure and human resources in health. CBHI has been publishing National Health Profile every year since 2005. Speaking at the function, the health minister stated that the data is an important source of navigation. "It helps in understanding the goals, our strengths and weaknesses and it is also an important means to strategize. Good compiled data enables the policymakers to make evidence-based policies and aids effective implementation of various schemes," he added. The health minister said that the e-book of NHP-2015 is a step towards realizing Prime Minister, Mr Narendra Modi's vision of Digital India. He stated, digital documents give us an opportunity for wider dissemination of information. He added that we now need to work towards converting documented data into "real-time" data. While digital data helps us to be more efficient, real time data helps to monitor our schemes and efforts in real time. Mr Nadda mentioned further, "Analysis of the data, to understand what is narrates, is equally important. Interpretation of data enhances its value, he said. It is necessary for people who work with data to be skilled in its analyses also. He suggested holding seminars/workshops to further that goal." Speaking on the occasion, Mr B P Sharma, health secretary stated that data is not only important for understanding the health indicators of the country, but it also provides an opportunity to monitor the situation. "The National Health Profile - 2015 indicates that significant progress has been made in the country for various health outcomes, which is an encouraging signal," he said. The National Health Profile highlights substantial health information under six major indicators viz. demographic indicators giving information about population statistics and vital statistics, socio-economic indicators which gives the information on education, social indicators, economic indicators, employment, housing and amenities, drinking water and sanitation, health status indicators which provide information about the incidence and prevalence of common communicable and non-communicable diseases, reproductive and child health according to States/UTs and a short overview of national programme for prevention and control of cancer, diabetes, cardio-vascular disease and stroke (NPCDCS). The health finance provides an overview of public expenditure on health, household out of pocket expenditure (Oop) on health, health coverage and insurance, external assistance to government for health sector programmes and public expenditure on health with international comparison along with explanatory notes on health data. The section on human resources provides an overview of availability of manpower working in the health sector, while health infrastructure provides details of medical and dental colleges, AYUSH institutes, nursing courses and paramedical courses, admissions to BDS and MDS courses. Also present at the release function were director general of health services, Dr Jagdish Prasad and senior officers of the ministry of health and CBHI. ]]> <![CDATA[M&A: Sun Pharma acquires US-based InSite Vision for Rs 300 cr]]> https://biospectrumindia.com/news/95/4613/ma-sun-pharma-acquires-us-based-insite-vision-for-rs-300-cr.html https://biospectrumindia.com/news/95/4613/ma-sun-pharma-acquires-us-based-insite-vision-for-rs-300-cr.html Tue, 22 Sep 2015 16:13:23 +0530 Sun Pharmaceutical Industries announced that one of its subsidiary has entered into a merger agreement with California-based InSite Vision for Rs 300 crore ($48 million). The acquisition is expected to close in the fourth-quarter of 2015. InSite is engaged in developing new specialty ophthalmic products. Sun Pharma, in a statement said that it is in the process of establishing a branded ophthalmic business in the US. "This proposed acquisition of InSite Vision and the recent in-licensing of Xelpros in June 2015 are steps in this direction," it said. Sun will now have access to four late-stage branded ophthalmic products in the US. For the 6-month period ended June 30, 2015, InSite Vision recorded revenues of $3.8 million, and a net loss of $7.5 million. Prior to Sun, in June 2015, Vancouver-based biotechnology company QLT proposed a merger bid with InSite. The transaction was mutually agreed by both the parties. QLT is involved in developing and commercializing innovative ocular products. On August 10, 2015, InSite released an official statement stating that it has received an unsolicited proposal from a 'multi-national pharmaceutical company' (Sun) to acquire all its outstanding shares at a price of $0.25 per share in cash InSite back then said that, in accordance with its existing merger agreement with QLT, its board of directors, in consultation with financial and legal advisors, will carefully review all aspects of the new proposal, and pursue the course of action that is in the best interests of InSite's stockholders InSite announced its determination to pursue possible merger with Sun. It however, still kept its options open by providing QLT with a possible amendment in its agreement to either match or exceed Sun's offer. On August 27th, the company announced its decision to stick to its first bidder, QLT, which came up with a bid equivalent to the matching price per share offered by Sun. "The amended merger agreement with QLT provides a significant improvement in value for our shareholders," said Mr Tim Ruane, InSite Vision's CEO. "The new agreement provides assurance of at least $0.25 per share and provides potential upside appreciation, depending on QLT's trading prices, to up to $0.30 per share." Under the revised QLT merger agreement, InSite would be required to pay $1,170,000 termination fee, and later was increased to $2,667,000, or approximately 5% of InSite's enterprise value. On September 3, 2015, Sun approached InSite a second time. This time to acquire all outstanding shares of InSite at an increased price of $0.35 per share in cash. The next day InSite officially made a statement about its possible interest in Sun's offer. On September 15th, the merger with Sun was finalized. InSite's termination fee worth $2,667,000 was paid by Sun to QLT. Guggenheim Securities acted as financial advisor to InSite, and Jones Day as legal advisor. InSite has developed DuraSite and DuraSite2 drug delivery platforms which are capable of extending the duration of drug retention, enabling lower dose frequencies and enhanced efficacy. It has three candidates namely AzaSite Plus (treatment of eye infection), DexaSite (treatment of non-bacterial blepharitis), and BromSite (treatment of inflammation and prevention of pain associated with cataract surgery) in phase-III stage; ISV-101 (treatment of dry-eye disease) in phase-II stage; and AzaSite Xtra in pre-clinical stage. Other candidates including ISV-102, ISV-620 and ISV-215 are still in various research stages. Its two commercialized products approved for the treatment of bacterial eye infections include AzaSite and Besivance. Commenting on the deal, Mr Jerry St Peter, VP & head, Sun Pharma's US ophthalmic business said, "....InSite Vision will bring with it a pipeline of three late-stage clinical candidates, validated drug delivery technology and a track record of achieving USFDA approval for ophthalmic products." Sun injects 7 percent of its annual revenues into its R&D. This month, Sun Pharma sold Ranbaxy's central nervous system (CNS) business to Bangalore-based Strides Arcolab for Rs 165 crore. Mr Kal Sundaram, CEO of Sun Pharma's North American business said, "This potential acquisition is a part of our overall objective of transitioning to a specialty company. Besides Dermatology, we have identified Ophthalmics as one of the key segments for establishing our branded presence in the US." In July 2015, Mumbai-based Lupin Pharma acquired US-based Gavis Pharmaceuticals for $880 million. India-based Cipla's UK arm acquired two US-based generic companies, InvaGen Pharmaceuticals and Exelan Pharmaceuticals for $550 million in early September. ]]> <![CDATA[Dr Reddy's, BioMarin settle patent issue]]> https://biospectrumindia.com/news/95/3783/dr-reddys-biomarin-settle-patent-issue.html https://biospectrumindia.com/news/95/3783/dr-reddys-biomarin-settle-patent-issue.html Tue, 22 Sep 2015 11:29:00 +0530 BioMarin Pharmaceutical has announced that it has entered into a settlement agreement with Dr Reddy's Laboratories (Dr Reddy's) that resolves patent litigation in the United States (US) related to BioMarin's Kuvan (sapropterin dihydrochloride) 100mg oral tablets. Under the terms of the settlement, BioMarin will grant Dr Reddy's a non-exclusive license to its patents related to Kuvan to allow the company to market a generic version of sapropterin dihydrochloride 100mg tablets in the US for the indications approved for Kuvan beginning at a confidential date in the future, but which is more than five years from today, or earlier under certain circumstances. Additional details of the agreement remain confidential. "This settlement agreement recognizes the strength of the intellectual property related to Kuvan and helps to ensure that patients who depend on Kuvan to manage their phenylketonuria (PKU) will continue to receive the medication and the range of support services offered to patients for years to come," said Mr Jeff Ajer, executive vice-president and chief commercial officer of BioMarin. "This settlement is beneficial to patients, clinicians, BioMarin and our shareholders, as it removes the cost, distraction nd uncertainty associated with this litigation." BioMarin continues to vigorously enforce its intellectual property related to Kuvan. This includes continuing its suit against Par Pharmaceutical which is not affected by this settlement. As required by law, BioMarin and Dr Reddy will submit the Agreement to the US Federal Trade Commission and the US. ]]> <![CDATA[Sun sells CNS divisions of former Ranbaxy for Rs 1,650 mn]]> https://biospectrumindia.com/news/95/7424/sun-sells-cns-divisions-of-former-ranbaxy-for-rs-1650-mn.html https://biospectrumindia.com/news/95/7424/sun-sells-cns-divisions-of-former-ranbaxy-for-rs-1650-mn.html Mon, 21 Sep 2015 15:11:27 +0530 Sun Pharmaceutical recently announced that it has entered into a definitive agreement with Bangalore-based pharma company Strides Arcolab, to sell erstwhile Ranbaxy's Solus and Solus Care divisions operating in the central nervous system (CNS) segment in India. In 2014, Sun acquired Daiichi Sankyo's Ranbaxy for a $4 billion deal. The acquisition was completed by Sun in March 2015 after facing a few merger-related regulatory hurdles. This new agreement involves transfer of the two marketing divisions, along with employees to Strides for a consideration of Rs 1,650 million. According to Sun, as per IMS July 2015 MAT report, all the products of these two divisions together accounted for approximately Rs 920 million in sales. Commenting on the transaction, Mr Abhay Gandhi, CEO, India Business, Sun Pharma said, "....Post successful completion of Ranbaxy's merger we had an opportunity to assess the entire portfolio of our India Business. We have evaluated each and every therapy segment that we are present in and how these businesses can grow going forward. Based on this evaluation, we firmly believe that the potential of Solus and Solus Care divisions can be greatly enhanced with the focus that Strides will put in growing them." During the divestment process, Sun Pharma was cognizant that the interests of its employees working in Solus and Solus Care divisions were not compromised, the company said in a press statement to Bombay Stock Exchange (BSE). Mr Subroto Banerjee, president, brands, Strides Arcolab said, "The acquisition of Solus and Solus Care divisions is of strategic significance to the growth of our branded business in India. The rich product portfolio and capable teams of these two divisions will help us establish a strong footing in the fast growing CNS market of India. The product portfolio of Strides and these divisions will strategically complement each other very well....." All other terms and conditions of the transaction have been kept confidential by the respective parties. On September 21, 2015, at 13:07 hrs, shares of Strides stood at Rs 1182.50, up 3.2 percent. Sun's shares was at Rs 900, down 0.56 percent. ]]> <![CDATA[FDA nod for Jubilant's generic drug for migraine]]> https://biospectrumindia.com/news/95/7426/fda-nod-for-jubilants-generic-drug-for-migraine.html https://biospectrumindia.com/news/95/7426/fda-nod-for-jubilants-generic-drug-for-migraine.html Mon, 21 Sep 2015 11:55:08 +0530 Jubilant Life Sciences has received Abbreviated New Drug Application (ANDA) final approval from the US Food and Drug Administration (US FDA) for Zolmitriptan Orally Disintegrating Tablets, 2.5 mg and 5 mg. The drug is the generic version of Zomig-ZMT(of Astra Zeneca), which is used for acute treatment of migraine headaches in adults. As on June 30, 2015, Jubilant Life Sciences had a total of 815 filings for formulations of which 389 have been approved in various regions globally. This includes 72 ANDAs filed in the US, of which 38 have been approved and 46 Dossier filings in Europe. ]]> <![CDATA[Responsibility of scientists to dispel rumors on technologies: DG ICMR]]> https://biospectrumindia.com/news/95/6227/responsibility-of-scientists-to-dispel-rumors-on-technologies-dg-icmr.html https://biospectrumindia.com/news/95/6227/responsibility-of-scientists-to-dispel-rumors-on-technologies-dg-icmr.html Mon, 21 Sep 2015 10:17:39 +0530 "'We need agencies such as Biotechnology Industry Research Assistance Council (BIRAC) and National Research Development (NRDC) to bridge gap between research and laboratories," opined Dr Soumya Swaminathan, DG, ICMR. She was addressing the gathering at the Thomson Reuters Research Excellence - India Citation Awards 2015 presentation event held on September, 18 in New Delhi. "Political leadership supports scientists. Prime minister has himself advised breaking of silos. He asked us to identify challenges of malnutrition through various programmes including creation of grand challenges. Earlier there used to be lack of coordination between various ministries but now 10-12 ministries that concern science in India, are working closely," mentioned the ICMR chief while talking about government policy. Dr Swaminathan urged the scientists to communicate more. She said, "Scientists cannot just do science but it is equally their responsibility to spread awareness. They must learn more to communicate with media and general public. Lots of misconceptions about technology and its products are floated from time to time creating a huge wedge between reality and myth. Our responsibility is to put in place the scientific facts and dispel rumors." The ICMR DG also emphasized on broadening scientific horizons. "The use of space technology and satellites can be used to make differences in lives of people," she concluded. Dr Swaminathan has recently joined the ICMR as DG and secretary, Department of Health Research (ministry of health and family welfare) with effect from August 17, 2015. She brings with her, the vast experience in health research and research administration. Prior to this assignment, Dr Soumya Swaminathan was director, National Institute for Research in Tuberculosis (NIRT) in Chennai since 2012. ]]> <![CDATA[Three bioscientists among others honored at Thomson Reuters India Citation Awards 2015]]> https://biospectrumindia.com/news/95/6230/three-bioscientists-among-others-honored-at-thomson-reuters-india-citation-awards-2015.html https://biospectrumindia.com/news/95/6230/three-bioscientists-among-others-honored-at-thomson-reuters-india-citation-awards-2015.html Mon, 21 Sep 2015 10:08:00 +0530 Ten of India's leading researchers were honored at Thomson Reuters Research Excellence - India Citation Awards 2015 presentation event held at the a glittering ceremony on September, 18 in New Delhi. As per the Intellectual Property and Science business division of Thomson Reuters, the awards represent India's continuing influence on global scientific research. Dr Soumya Swaminathan, director general, Indian Council of Medical Research (ICMR) and secretary, Department of Health Research who was the guest of honor at event, congratulated the awardees. The keynote address was delivered by Dr H Purushotham, chairman and M D, National Research Development Corporation (NRDC). The India Citation awards study mines scientific research citations within Web of Science - the premier global search and discovery platform to identify most influential researchers in the country. Out of ten India Citation Awards winners in 2105, three belonged to biosciences. These included Dr A Banerjee- fellow, Royal Society of Chemistry, UK, professor- Biological Chemistry, Indian Association for the Cultivation of Science; Dr A Ramachandran, chairman, Dr A Ramachandran's Diabetes Hospitals president, India Diabetes Research Capital and Dr Rajeev Varshney- director, International Crops Research Institute for the semi-arid tropics, Center of Excellence in Genomics. Commenting on the awards, Mr Arvind Pachhapur, South Asia head - Intellectual Property and Science and Legal Business, Thomson Reuters mentioned, "India has always been an important contributor to the global research output. The Thomson Reuters India Citation Awards aims to encourage and celebrate excellence in research by objectively identifying highly impactful work." The scientists under other categories included Dr Vinay Gupta- IUSSTF(Indo-US) University of California Scientist, Physics of Energy Harvesting, CSIR National Physical Laboratory; Dr A K Srivastav, visiting scientist, US Army Laboratory, Maryland, USA, professor- Analytical Chemistry University of Mumbai; Dr Prithwish Tribedy, scientist Variable Energy Cyclotron Center, Kolkata; Dr Rahul Bannerjee, principal scientist, Physical and Materials, Chemistry Division, CSIR-National Chemical Laboratory; Dr S Ramaprabhu-professor, Department of Physics, Indian Institute of Technology, Madras, Chennai; Dr Swagatam Das, assistant professor, Electronics and Communications, Science unit, Indian Statistical Institute, Kolkata, and Dr Vandana Bhalla- assistant professor, Gurunanak Dev University, Amritsar , Category- Organic Chemistry. Research methodology for the 2015 Thomson Reuters Research Excellence - India Citation Awards: â– Only papers indexed in Thomson Reuters Web of Science database that listed an author address from India were examined. â– Only papers published in the five-year period 2010-2014 were reviewed. â– From the identified corpus, a search was made for highly cited papers, defined as papers ranking in the top 1% by citations compared with other papers in the same broad field and of the same publication year. â– From this analysis, 10 high-impact Indian scientists were identified whose recent papers represented the strongest research performance in their research area in terms or number of highly cited papers and total citations to these highly cited papers. ]]> <![CDATA[Innovators term expanding innovation system a priority]]> https://biospectrumindia.com/news/95/7479/innovators-term-expanding-innovation-system-a-priority.html https://biospectrumindia.com/news/95/7479/innovators-term-expanding-innovation-system-a-priority.html Fri, 18 Sep 2015 14:32:00 +0530 During the last three years, Biotechnology Industry Research Assistance Council (BIRAC) has organized the annual innovators meet in September each year and these has been very well received by all the stake holders. This time around too, the event witnessed bigwigs of biotech industry and academia coming together on a government sponsored platform. Held for the fourth time on September 15-16, 2015, at Manesar in National Capital Region, the BIRAC's annual innovators meeting was themed 'Invigorating the Biotech Innovation Ecosystem'. The event's focus was on innovators, who interacted, networked and discussed successful case studies, challenges and opportunities for strengthening the biotech enterprise. The event saw the participation of BIRAC funded innovators, key partners and of course, all connected stakeholders. While welcoming the delegates, Dr Renu Swarup, managing director, BIRAC mentioned, "This platform has repeatedly proven to be of great help in exchange of ideas between entrepreneurs." When we started, there were no funds available to individuals. After Dr M K Bhan suggested to us, we took specific steps to address it." Dr Swarup listed out the action taken report on in 2014. She explained, ""It is very interesting to know that how we made our pan India presence felt. In last 3 years, we have 155 innovators." She thanked innovators who responded to recent survey conducted by BIRAC. Adding further, Dr Swarup said, "We are now focusing on the areas that require out more attention. It is very heartening to find out that 45 of the BIG funded innovators later founded their own firms. Well qualified 500 skilled professionals (MSc and PhD) have availed benefits. Scaling up our operations is high on agenda." BIRAC chief also talked about challenges. She admitted that the communication has not been enough and more needs to be done on that front. "BIRAC equity fund has not been operationalized so far due to fewer funds. We know that there will be lot of applicants and don't want to deny it to right ones. We are working on it and hopefully will have full support from the government as the Prime Minister's announcement on start up mission is encouraging," she mentioned. The innovators meet has proved to be an excellent platform for knowledge exchange and networking among the young entrepreneurs, startups, SMEs and companies and also to discuss important issues which are critical for the scale up of the biotech innovation ecosystem. In his keynote address, Dr M K Bhan, former secretary, department of biotechnology (DBT) mentioned that biotech is maturing globally and we should have patience to reap its benefits. He elaborated, "While starting today, impact cannot happen tomorrow. Keep believing and supporting the research till maturity. Science can find solutions as soon as possible given the support and patience. Recently how Ebola vaccine was developed in such as a short duration is an interesting example. The way regulations fell in place due to social obligations too was a good precedent." Talking about the future, he listed out the focus areas. "Science and technology at the university level has to be given maximum attention. Generally, it is seen that the leaders of institutions are ill prepared. Leadership building programme plays a very important role. Best that biotech has to offer will happen in next 15 years. Let us not slow down due to few issues. Great nations foresee opportunities and our nation apart from manufacturing should also pay attention to innovation." "No ecosystem grows in a systematic way. Few components grow faster and few are slower. Besides needing the connect between them, there is requirement of being tough and enduring in this long journey of entrepreneurship," added Dr Bhan. Speaking on this occasion, Prof K VijayRaghavan, chairman, BIRAC and secretary, DBT, talked about challenges and working towards solutions to fix them. "Expansion of BIRAC only would not solve all issues as it cant be the alone torchbearer. There have to be more BIRAC like organizations. There are too many challenges and what BIRAC which has got overburdened can do, is to scale up its resources," he said. Secretary also opined that SME's can be truly transformative and brainstorming is required between these and the NGOs within the sector. He called for efforts to seek funds from various sources apart from fixed budget." Dr G Padmanabhan, NASI-Chairman and former director, Indian Institute of Science in his address mentioned, "Industry must be brought into mentoring committees. It should not only be the government officials as making it multi-faceted shall ensure its credibility and build confidence." The first day of the event witnessed presentations from BIRAC awardees and intense deliberations on their ideas. The BIG Innovator awardees presented their ideas before the audience and were much appreciated. The first panel discussion on building and scaling biotech innovation in India was moderated by Dr Renu Swarup and the distinguished panel comprised of Prof Anil Gupta, IIM Ahmedabad; Mr David Gill, managing director, St John's Innovation Centre, Cambridge; Prof C B Sanjeevi, Karolinska Institutet, Sweden; Ms Deepanwita Chattopadhayay, chairman and CEO, IK Knowledge Park and Mr Sharad Sharma, IKP Knowledge Park. During the discussions, Prof Anil Gupta highlighted the fact that areas having inadequacies need to be identified and we must fine tune our own system to match the aspirations of middle class youth. "The background and struggles of an entrepreneur coming from middle or lower strata of society, cannot be looked away," he pointed out rightly. Prof Gupta also emphasized on the need to identify the gaps in laboratory equipments and development of indigenous technologies by putting the needs before designing teams. "That can trigger innovation and thus create new avenues for entrepreneurs," he added. The deliberation was followed later by the parallel sessions on healthcare, agriculture economics and clean energy. The healthcare session had two topics that were deliberated upon separately. While one was on strategies for addressing antimicrobial resistance (AMR) issues in India, the other was on integrating big data analytics in personalized medicine for standard care. Under agriculture, the economics of it was discussed with focus on revolutionizing productivity and quality. The session on energy was dedicated to biotech solutions for 'Swachh Bharat' to ensure clean energy. Anchored by Dr Satya Dash, COO, BIRAC, the event went on smoothly with interactions happening between the private investors, accelerators and other key players of the ecosystem. In the evening, a candid talk and interaction session of the participants was held with Dr K VijayRaghavan. On September 16th, the second day of the event, Dr R A Mashelkar, chancellor, AcSIR and national research professor, NCL, Pune gave his plenary lecture on building India as an innovation hub. "In India, we must move from publish or perish to patent, publish and prosper," he said. It was followed by the interaction between mentors and innovators where there were presentations and a panel discussion. BIRAC, in the last few years has been making a concerted effort to stimulate and nurture a vibrant biotech innovation ecosystem. It has created a network of over 350 Startups, SMEs and nearly 150 young entrepreneurs engaged in innovation research for affordable product development. BIRAC has helped catalyze an ecosystem ranging from seed funding to early and late stage product development support, access to research resources and required infrastructure and most importantly mentorship and networks. ]]> <![CDATA[Serum in talks to sell 10% stake]]> https://biospectrumindia.com/news/95/6613/serum-in-talks-to-sell-10-stake.html https://biospectrumindia.com/news/95/6613/serum-in-talks-to-sell-10-stake.html Fri, 18 Sep 2015 14:28:25 +0530 According to a Bloomberg report, Dr Cyrus Poonawalla, CMD, Serum Institute, the largest vaccine maker in the Asian continent, is in talks with private equity (PE) firms to sell 10 percent stake in the company. Selling a 10 percent stake at a valuation of $12 billion would be the largest private-equity investment in India, according to the data compiled by Bloomberg. Serum is in talks with firms in Singapore and the US. Bloomberg also reported Mr Adar Poonawalla, Serum's CEO & executive director, as saying that the company will decide on whether to sell a stake in the next 1-2 months. "We're just waiting to hear back from the funds on their conditions and their valuations and what they would expect," Mr Adar Poonawalla told Bloomberg in an exclusive interview dated September 16, 2015. "Then we'll go from there." ]]> <![CDATA[University of Hyderabad to organize BioQuest 2015]]> https://biospectrumindia.com/news/95/8371/university-of-hyderabad-to-organize-bioquest-2015.html https://biospectrumindia.com/news/95/8371/university-of-hyderabad-to-organize-bioquest-2015.html Fri, 18 Sep 2015 11:40:49 +0530 The event is being organized to showcase the ongoing teaching and research programs, infrastructural facilities and expertize of the faculty in different areas of lifesciences to the industry. Leaders from the Biotech and Pharma industry will participate in the event. The two day event to be held at the SLS Auditorium, will be inaugurated by Dr Lalji Singh, former director, Centre for Cellular and Molecular Biology (CCMB). The topics that will be covered are Plant Biology and Biotechnology, Drug Discovery and Development, Cellular and Molecular Biology ,and Innovation and Entrepreneurship. The event will also have student's presentation, poster presentations and the award ceremony. For more information, visit: http://www.uohyd.ac.in/ ]]> <![CDATA[Grand challenges winners awarded certificates at BIRAC Innovators Meet 2015]]> https://biospectrumindia.com/news/95/7197/grand-challenges-winners-awarded-certificates-at-birac-innovators-meet-2015.html https://biospectrumindia.com/news/95/7197/grand-challenges-winners-awarded-certificates-at-birac-innovators-meet-2015.html Fri, 18 Sep 2015 10:13:42 +0530 The Grand Challenges India initiative was jointly launched by the BIRAC, DBT and the Bill and Melinda Gates Foundation (BMGF) in 2013 to promote innovative health and development research within India, exclusively for Indian researchers. Till date, the two previous grants, 'Achieving Healthy Growth through Agriculture and Nutrition'and 'Reinvent the Toilet Challenge' have collectively funded ten researchers and social entrepreneurs from across the country. The winners of the 'All Children Thriving' grants of the Grand Challenges India initiative were awarded the certificates for funding at the 4th BIRAC's Innovator's Meeting held on September 15-16, 2015 at Manesar in National Capital Region (NCR). The awards were given by Dr K Vijay Raghavan, secretary, department of biotechnology (DBT), government of India. Speaking on the occasion, Dr Vijay Raghavan stated, "Stimulating an atmosphere of research is one of the major instruments to tackle the problems plaguing the country. The Grand Challenges initiative has grown tremendously in the past decade and partnerships have played a key role through knowledge sharing and cross pollination of ideas. Through the Grand Challenges programme, we aim to create a conducive 'innovation ecosystem' in the country to encourage creativity and inventiveness among young researchers." "India has one of the highest child mortality rates and under-five deaths in the world. The selected proposals under the 'All Children Thriving' initiative focus on promoting interventions which aim to ensure that children live healthy and productive lives. Our target of improving lives can be made possible only by embracing innovation in the country and the DBT- BMGF- BIRAC partnership through Grand Challenges has made great strides in this regard," said Dr Renu Swarup, managing director, BIRAC. The 'All Children Thriving' grants aim to develop multi-sectoral interventions that can reduce the burden of preterm birth, stunted postnatal growth, and impaired cognitive development. In India, an estimated 26 million children are born every year. An estimated 1.27 million children die every year before completing 5 years. 81 percent of under-five child mortality takes place within one year of birth which accounts for nearly 10.5 lakh infant deaths and 57 percent of under-five deaths take place within the first one month of life accounting for 7.3 lakh neo-natal deaths every year in the country. "Innovation plays a central role in developing societies. Encouraging and fostering research and development of interventions meant to improve the quality of life is crucial. Grand Challenges provides a platform for innovators to think creatively to develop cost-effective and sustainable interventions. The 'All Children Thriving' grants concentrate on a vital stage of life where effective interventions can be incredibly beneficial in changing the lives of millions of children," said Mr Trevor Mundel, president of the Global Health Division, Bill and Melinda Gates Foundation.The speakers at the event emphasized the need to stimulate interest in research and development in the country to address the various health issues. There was also discussion on creating economical and sustainable solutions, keeping in mind ground realities is the need of the hour. ]]> <![CDATA[1400 patients benefit from embryonic stem cell therapy]]> https://biospectrumindia.com/news/95/7457/1400-patients-benefit-from-embryonic-stem-cell-therapy.html https://biospectrumindia.com/news/95/7457/1400-patients-benefit-from-embryonic-stem-cell-therapy.html Fri, 18 Sep 2015 10:07:00 +0530 Almost 1400 patients suffering from incurable or terminal diseases have got a new lease of life with human embryonic stem cell therapy till date. This was revealed recently at the '11th national comprehensive course in cardiovascular surgery' commemorating 50 years of excellence in cardiac surgery organized by GB Pant Institute of Post-Graduate Medical Education and Research. The human embryonic stem cell therapy involves injecting the cells to help repair the affected area and restore the missing function of the body. These cells neither require any cross matching as in the case of adult stem cells nor do they require storage of umbilical cord blood. Upon transplantation, they do not elicit any immune reaction. Dr Geeta Shroff, founder and medical director of Nutech Mediworld Hospital said, "Human embryonic stem cells have the potential to develop into more than 200 cell types. The technology can be successfully used to treat many of the incurable diseases and injuries that were not possible before" The technology invented in 2002 by Dr Geeta Shroff successfully isolates purely human embryonic stem cell lines using just a single, spare fertilized egg from a regular IVF cycle. Over the last 13 years, the technology has helped many patients recover from various incurable conditions via cell repair and tissue regeneration. Studies have shown it can help regenerate heart muscles destroyed by heart attacks. Human embryonic stem cells have a unique ability to transform into different tissue or organ specific cells, thereby increasing the scope of its applications. The technology developed by Dr Shroff is being used for treatment of many incurable diseases ranging from Spinal cord injury, Diabetes, ALS, Cerebral palsy, Stroke, Parkinson's disease and others. Informing that work on human embryonic stem cell therapy has been published in more than 20 international journals, Dr Shroff said, "With safety and efficacy of hesc being established over the years, it is time to make this therapy available widely as a first line of treatment in order to improve the quality of life of patients suffering from conditions presently labeled incurable or terminal." Human embryonic stem cell technology differentiates itself from other stem cell therapies in three major ways. Firstly, it has universal application, i.e. anyone and everyone can take these cells without the need for matching. Secondly, it is available in a ready to use form with a shelf life of six months and can be transported easily. Thirdly, it has an easy non-invasive delivery mechanism and can be administered in the simple form of an injection. The national conference was attended by doctors, researchers, scientists, physicians and delegates from various medical institutes and hospitals such as AIIMS, MAMC, RML, Gangaram, Max, etc. The main objective of the course was to share knowledge and findings about the latest scientific advancements. ]]> <![CDATA['Entrepreneurship starts with your own dream']]> https://biospectrumindia.com/features/95/7503/entrepreneurship-starts-with-your-own-dream.html https://biospectrumindia.com/features/95/7503/entrepreneurship-starts-with-your-own-dream.html Wed, 16 Sep 2015 17:52:09 +0530 While in school Dr Abhay enjoyed rearing fish and photography as his prime hobbies, which enabled him to set up a small business, giving him the leverage of having enviable amounts of money in his pocket at his disposal for trying out newer ideas. He was always influenced by his grandmother, who single-handedly managed the family-owned agriculture venture in a unique and sustainable manner. Dr Abhay holds a PhD in Microbiology (Molecular Biology) from National Chemical Laboratory (NCL), Pune, and has been working as an entrepreneur for the last 20 years. His doctoral research was influenced by Dr R A Mashelkar who emphasized that scientists should be able to convert their knowledge in to material wealth. During that time, Dr Abhay zeroed in on jumping into entrepreneurship and seriously started reading journals on R&D policy and management. Simultaneously, he was also working on an agriculture project called 'Bharat Yatra Kendra', where he closely experienced the problems faced by common farmers. On one hand he was armed with his grandmother's wisdom and unique way of handling agriculture problems, and on the other he had an exposure to the latest technologies and research. "This was the time when ideas about 'agri-entrepreneurship' started bubbling in me and there was some scope for testing them," says Dr Abhay Shendye, founder & director, Swasti Agro & Bioproducts. Swasti is a four-year-old agricultural start-up, incubated at Venture Center, Pune. The start-up focuses on sustainable farming involving specialty biomolecules and microbes that are difficult to cultivate. Unique combinations of these two components are used to solve key problems in agriculture such as soil fertility, crop productivity, and disease management. In fact, Swasti is Dr Abhay's third venture in the space of technology development, and manufacturing of inputs for sustainable agriculture. Prior to this, he established his first proprietary venture AgroBioTech, a commercial R&D company, in 1995. "By the end of my doctoral research, I was almost certain to get a formal training for a few years and start my own enterprise. But the system did not allow for the declaration of doctoral degree for over two years after submission of the thesis, and I jumped unplanned into the passionate arena of sustainable agriculture. The entrepreneurial journey that started with Agrobiotech in 1995 remained unstructured and random till 2011 when Swasti was incorporated. The time money and personal sacrifice of these 15 years can't be estimated in monetary terms. But it gave priceless experience which is helping Swasti to grow leaps and bounds in no time," explains Dr Abhay recalling his journey. He also was involved in setting up his second dreamy manufacturing venture and a partnership firm, ABT Bioproducts. When he started AgroBioTech, it already had its own research lab to start the initial work. "Thanks to about a lakh of rupees earned in photography and invested to build a small research facility at home. But as a venture it was not structured with respect to business plan, financial model, or a team. There was no mission and vision statement written down. No targets and goals set. Keen interest in building sustainable agriculture techniques for farmers was the key driving force," points Dr Abhay. Back then, it was a challenging time for Dr Abhay. But the confidence within him kept telling that something can be done for the sustainable farming, and some day it is all going to convert the knowledge into huge material wealth. During those times, Dr Abhay looked upon Dr Alejandro Zaffaroni, the most successful serial entrepreneur in the biotech space in those days. In 2011, it was another fresh start for Dr Abhay. The incorporation of Swasti. "It was started with an authorized capital of Rs 10 lakh of which 65% is paid up so far. We got a grant of 42 lakh rupees from BIRAC- DBT, and raised debt against FD of rupees 27 lakh. All accrued profits were ploughed back, and now the sum total of investment is close to a crore rupees. First three years were of technology refinement, and we nurtured the company on some contract manufacturing," reveals Dr Abhay. Swasti is devoted to building disease resistance in horticulture crops. Dr Abhay says that the company has identified 16 crop-disease combinations important for India to begin with. "The market size is over Rs 15,000 crore. We have some specific enquiries from South Africa, Israel, and New-Zealand. But our current focus is bacterial blight disease of pomegranate. There is no potent solution for this disease as of today. The need for an alternative is dire," he comments. Swasti tailor-makes solutions for diseases caused by all types of pathogens - bacteria, fungi, viruses, and nematodes. He continues, "Thus, the scope is immense. Therefore a specific expansion strategy is needed." For the first two years, the company will focus on India for revenues and complete demonstrations, and regulatory in other Asian countries. "The developed countries will follow so after that," he adds. For some crops, the company has strategic ties with large corporates. "Thus large part of our marketing operations will soon become B2B. This will allow us to focus on our core strength R&D. However, at this point of time, we have to take lead in establishing this new concept amongst the end-users. So we operate largely B2C, and we are in to all diverse segments of operation including technology development, manufacturing, marketing, and sales," Dr Abhay mentions. For the company, the year 2015-16 is going to be crucial. Dr Abhay points, "For the first five months of the year we have displayed 5X increase in the revenue over same period of the previous year. This is irrespective of the severe drought situation. We will have displayed reasonably good scale up, yet targets for next two years will have to be reworked on the basis of this performance. But in any case we will cross Rs 100 crore turnover within the fiscal 2017-18. To achieve this we require capital infusion." So far, Swasti has been shortlisted for a couple of grants and soft loan opportunities under government schemes. "We are also in the process of talking to PE investors. With this we will have scope for rapid growth. This growth assumption is not based only on the revenue traction. We have reached milestone in business and developments such as patent application, development of android application called 'Happy Crop' for farmer interactions with more than thousand users," says Dr Abhay. "Unfortunately in India, I think, very few start-ups get funds at an early stage to provide solid PoC. Swasti was lucky to get such a grant from BIRAC DBT." Dr Abhay notes that incubators, accelerators, and mentorship were unheard words in India when he started his first venture in 1995. He optimistically says that the start-up ecosystem in India is developing rapidly. "It is very good for the upcoming entrepreneurs. I must acknowledge the support from Venture Center and TiE in Pune through their Ekalavya scheme and Nurture program which have added value to the Swasti endeavor," he acknowledges. Dr Abhay says that several budding entrepreneurs who have all the necessary support still make the same mistakes his generation did 20 years ago. "Thus, this entire changing ecosystem finally remains only a tool for one to improve as per his or her capacity and wish," he observes. He highlights that VC funding has become abundant over the last ten years. "However, since the funds want rapid growth, VCs prefer IT and technology over manufacturing and drug discovery, or biomedical over agriculture. There are very few funds such as Omnivore and SEAF that do have agriculture as a funding mandate," he expresses. As a final thought on entrepreneurship, he elaborates, "Entrepreneurship starts with your own dream. If you dream big, you might see a larger horizon when successful. Nobody will support your dream till you fill colors into it, and make it visible, and more so very attractive. You are the only person responsible to turn your dream into a reality. The journey is hard. And in the process you also face very boring challenges such as cash flow management. At times some challenges may form scary parts of the dreams. But as long as you don't give up your creativity, you don't stagnate. If you have guard in each and every nook and corner of your dream, and don't cross your limits, then the journey is never stressful. There will be failures. But these are failures of the particular ideas. If you fail fast and manage to move ahead, you will still be able to fulfill your dreams, because a true entrepreneur never fails." ]]> <![CDATA[Glenmark's Bi-Specific Antibody - GBR 1302 to enter Phase I trials]]> https://biospectrumindia.com/news/95/7351/glenmarks-bi-specific-antibody-gbr-1302-to-enter-phase-i-trials.html https://biospectrumindia.com/news/95/7351/glenmarks-bi-specific-antibody-gbr-1302-to-enter-phase-i-trials.html Wed, 16 Sep 2015 12:02:03 +0530 Glenmark Pharmaceuticals S.A. (GPSA), a wholly owned subsidiary of Glenmark Pharmaceuticals Limited India (GPL), announces the completion of Phase 1 supporting studies and the submission of a clinical trial application to the Paul-Ehrlich Institute in Germany with a novel clinical development candidate, GBR 1302. GBR 1302 is a HER2xCD3 bi-specific antibody based on Glenmark's proprietary BEAT platform. GBR 1302 is the first clinical development candidate based on the BEAT technology. Glenmark expects to obtain approval for the initiation of clinical studies with GBR1302 during this financial year. GBR 1302 material for Phase 1 clinical trials was manufactured in Glenmark GMP production unit in Switzerland. HER2, also known as HER2/neu, or receptor tyrosine-protein kinase erbB-2, is the target of the antibody cancer drugs trastuzumab, pertuzumab and trastuzumab emtansine and is implicated in breast cancer, ovarian, gastric, and certain uterine cancers. Commenting on this milestone, Dr Michael Buschle, chief scientific officer and president - Biologics, Glenmark Pharmaceuticals said, "We have high expectations for GBR 1302. During the preclinical characterization of the bi-specific antibody we have discovered that GBR 1302 does not only kill trastuzumab resistant cancer cells, but also very efficiently kills cancer cells with a weak expression of HER2 against which all current HER2 targeting antibodies are not effective." GBR 1302's mode of action is different from current HER2 targeting antibodies. It redirects cytotoxic T cells through its CD3 binding arm onto HER2 expressing cancer cells and induces the killing of the cancer cells. Preclinically, the killing of cancer cells by GBR 1302 is more rapid, more complete and not expected to be subject to the same resistance escape mechanisms as therapies directed against HER2. ]]> <![CDATA[Biocon inaugurates Devices Facility & Introduces Basalog One ]]> https://biospectrumindia.com/news/95/7153/biocon-inaugurates-devices-facility-introduces-basalog-one-.html https://biospectrumindia.com/news/95/7153/biocon-inaugurates-devices-facility-introduces-basalog-one-.html Wed, 16 Sep 2015 09:59:22 +0530 The facility was inaugurated by Mr. Amitabh Kant, Secretary, Department of Industrial Promotion and Policy, Govt. of India along with Mr. Kaushik Mukherjee, Chief Secretary, Government of Karnataka and Ms. V. Manjula, Secretary, IT,BT and S&T, Government of Karnataka. Mr Kant also launched Basalog One, a high-end, ready-to-use insulin glargine disposable pen for better blood sugar management for people with diabetes, manufactured in this facility. The 100,000 square feet, new devices facility set up in Bangalore is an outcome of Biocon's commitment to 'Make in India for the World' which is well aligned with the Government's 'Make in India' vision to transform the country into a global manufacturing hub. Biocon has taken the lead to take this mission forward in the area of pharmaceutical and biomedical devices and invested significantly in the facility that will provide direct and indirect employment to several hundred people. The facility will enable Biocon to leverage the country's manufacturing expertise to develop world-class delivery devices for people with diabetes in India and other parts of the world. Biocon's Basalog One, a long acting basal insulin glargine presented as an innovative, pre-filled pen, is the first product to roll out of this facility. Basalog One as a 'once a day' product is convenient to administer and almost painless, which will enable better patient compliance and help patients manage their blood sugar levels most effectively. The pen is light weight, easy to carry and disposable. The introduction of Basalog One further strengthens Biocon's existing Basalog portfolio comprising vials, refills and reusable devices thus enabling company to offer a comprehensive diabetes management solution for people with diabetes. Biocon's Basalog, launched in 2009, has benefited several lakhs of patients in India. Speaking at the launch, Mr. Amitabh Kant, Secretary, Department of Industrial Policy and Promotion, Govt of India, said, "I want to congratulate Biocon on the inauguration of this new facility and the launch of Basalog One This product, made in such a top class facility, will make a radical difference in the lives of many millions of diabetes patients globally. It's a huge step forward for such a product to be 'Made in India'. I am proud of the Biocon team for the focus they have exhibited in making this dream a success." Ms Kiran Mazumdar-Shaw, Chairperson & Managing Director, Biocon, said: "Our aim is to provide insulin products to at least one in five insulin-dependent diabetes patients, anywhere in the world. This new devices facility is a key milestone in our journey towards that goal. It will enable us to not only fulfil our commitment to 'Make in India for the World' but also deliver on the promise of 'Affordable Access to Healthcare for All'. Through our product Basalog OneTM, we will be providing a high -end patient friendly basal insulin glargine pen in India first and global markets, subsequently." Dr Arun Chandavarkar, CEO & Jt. Managing Director, Biocon, said: "India has the potential to become the next global manufacturing hub in biomedical devices and at Biocon, we are committed to explore this potential. As we expand our reach in global markets to provide access to affordable diabetes therapy options, Basalog OneTM will form a significant part of our offering to people with diabetes in different parts of the world." The global insulin delivery devices market, estimated at $9.4 billion in 2014, is expected to grow at a CAGR of 7% to reach an estimated $14.1 billion in 2020. While Asia is tipped to be the fastest growing market for insulin delivery devices due to rapid economic and social change leading to higher incidence of diabetes in the region, the US presents the largest market opportunity for these devices followed by EU. Biocon has collaborated with Becton Dickinson & Co. (BD), a leading global medical devices company based in the US, to specially customize the design of this device to enable it to deliver Biocon's range of insulin products. Basalog One is built at Biocon's new devices facility using a 3 ml cartridge of 100IU insulin glargine manufactured by Biocon. The active drug substance and the drug product for the pen is being manufactured by Biocon in India. Biocon's Basalog One is a first-of-its-kind, disposable insulin glargine pen, designed internationally and built locally for the global markets. ]]> <![CDATA[Suicide needs attention as a public health problem: WHO]]> https://biospectrumindia.com/news/95/7207/suicide-needs-attention-as-a-public-health-problem-who.html https://biospectrumindia.com/news/95/7207/suicide-needs-attention-as-a-public-health-problem-who.html Tue, 15 Sep 2015 16:41:48 +0530 At the individual level, early identification of mental disorders and appropriate management and recognition of suicidal behaviors is helpful. Large-scale advocacy efforts are required to reduce the stigma related to suicides. The WHO's South-East Asia Region contributes to 39% of global suicides. Suicide in the region is mainly a problem of the younger age groups. "As large numbers of people in the region are predominantly rural, the occurrence of suicides is generally much higher in the rural parts of South-East Asia. Suicide is preventable with timely, evidence-based low-cost interventions. Measures can be taken at population, subpopulation and individual levels to prevent suicide and suicide attempts," said Dr Poonam Khetrapal Singh, regional director, WHO South-East Asia region. The World Suicide Prevention Day is a call for action by countries, organizations, communities and individuals for joint action to raise awareness about suicide and suicide prevention. Suicide needs attention as a public health problem not only because of the huge social and emotional burden it has on the family and society, but also because of the scope of prevention that it presents. Every 40 seconds a person commits suicide somewhere in the world. Every year more than 800 000 deaths are caused by suicide and there are several other attempted suicide cases. Suicide is the second leading cause of death among 15-29-year-olds globally. ]]> <![CDATA[Jubilant inks marketing pact with Cyclopharm ]]> https://biospectrumindia.com/news/95/6352/jubilant-inks-marketing-pact-with-cyclopharm-.html https://biospectrumindia.com/news/95/6352/jubilant-inks-marketing-pact-with-cyclopharm-.html Tue, 15 Sep 2015 11:47:48 +0530 Jubilant Life Sciences has announced that one of its wholly-owned subsidiaries, Jubilant DraxImage Inc ("DraxImage") has signed a term sheet, with Cyclopharm Limited ("CYC"), providing DraxImage an exclusive license to market and distribute Technegas in the United States. The deal is subject to satisfactory due diligence and execution of the definitive agreement and other necessary approvals. Technegas is an imaging agent primarily used in Pulmonary Embolism (blockage of lung arteries) and is currently being sold in 55 countries including EU, Japan and Canada by CYC. DraxImage will assist CYC with the development and financing of the phase III clinical trials for Technegas, and any other steps required to file for and obtain USFDA approval. As per the agreement, DraxImage will provide at risk up to $4.5 million to fund the USFDA clinical trial currently under development with any additional costs to be funded by both parties equally. Upon successful completion of the trial, DraxImage will be able to convert USFDA trial costs into CYC common stock up to a maximum of 15 percent of the total CYC shareholding. DraxImage will pay CYC a 17.5 percent royalty on sale in addition to an agreed margin above the cost of goods sold. Commenting on the occasion, Mr Shyam S Bhartia, chairman and Mr Hari S Bhartia, co-chairman and managing director, Jubilant Life Sciences said, "We are pleased to partner with CYC for the clinical development and potential US market introduction of Technegas. This partnership reiterates our commitment to add innovative products in our Radiopharmaceuticals portfolio and will leverage our existing strengths in the nuclear imaging business." ]]> <![CDATA[Dr Reddy's ink multimillion-dollar pact with Oz firm]]> https://biospectrumindia.com/news/95/7093/dr-reddys-ink-multimillion-dollar-pact-with-oz-firm.html https://biospectrumindia.com/news/95/7093/dr-reddys-ink-multimillion-dollar-pact-with-oz-firm.html Mon, 14 Sep 2015 16:06:16 +0530 The deal will enable Dr Reddy's to commercialize Hatchtech's head lice product, Xeglyze Lotion, which was previously called as DeOvo. As part of the agreement, Dr Reddy's will pay Hatchtech an upfront amount of $10 million, up to $50 million based on pre-commercialization milestones, and an undisclosed amount based on post-commercialization milestones, linked to achievement of annual net sales targets, Dr Reddy's told Bombay Stock Exchange (BSE). Xeglyze is used in for treating head lice infestation experienced by children and their parents. The rights for this product are applicable for territories including the US, Canada, India, Russia and the CIS, Australia, New Zealand and Venezuela. Hatchtech also announced that it will be filing its New Drug Application (NDA) for Xeglyze with the US Food and Drug Administration (FDA) today. If approved, the product will be marketed in the United States by Promius Pharma, a wholly-owned specialty company of Dr Reddy's Laboratories, said Dr Reddy's in a statement. In September 2014, Hatchtech announced positive results from its two pivotal Phase-3 clinical studies evaluating Xeglyze Lotion as a potential treatment for head lice infestation. The clinical studies involved 704 people, across 14 clinical trial sites in the US and resulted in an 81.5% success rate, following the observation period of 14 days, after a single 10 minute application. Hatchtech is a specialty pharmaceutical product company located in Melbourne, involved in developing technologies for controlling invertebrate pests. The company was originally founded through programs that originated at the University of Melbourne in Australia, according to Hatchtech. It is a venture-backed private company by investors including GBS Venture Partners, Queensland Biotechnology Funds, Uniseed, University of Melbourne Endowment Trust, AustralianSuper, OneVentures Innovation Fund, and Blue Sky Alternative Investments. Mr Hugh Alsop and Dr Vern Bowles serve as Hatchtech's CEO and CSO respectively. ]]> <![CDATA[Make universal health coverage a reality: WHO ]]> https://biospectrumindia.com/news/95/7085/make-universal-health-coverage-a-reality-who-.html https://biospectrumindia.com/news/95/7085/make-universal-health-coverage-a-reality-who-.html Mon, 14 Sep 2015 14:03:40 +0530 "Health is critical to development. Access to safe, affordable and good quality health services enables people to be more productive and active contributors to their families, communities and nations," Dr Poonam Khetrapal Singh, regional director, WHO South-East Asia Region, said at the WHO Regional Committee meeting held in Dili, Timor-Leste. Making effective healthcare services accessible to people, wherever they live, and whether they are rich or poor, is a must. It makes commitments to a fairer society real, and will facilitate sustainable development, she said. Universal health coverage (UHC) figured prominently at the five-day Regional Committee meeting between 7 - 11 September, attended by Health Ministers and high-level ministerial delegations of all 11 countries of WHO South-East Asia Region. WHO emphasized that action for UHC needs to take into account the changing health needs. With the increase in non-communicable diseases and the rise in numbers of the elderly, often with multiple health conditions, a new thinking is needed on ways to deliver health services. "We need to learn more about new service delivery models that aim to give people access to the care they need, when they need it, without suffering financial hardship. The question is how well they are working," said Dr Khetrapal Singh. The ways to achieve UHC are becoming clearer. The number of poor people paying out of their own pocket for care when they are sick needs to be reduced as this increases their hardship. Governments need to invest more into strengthening their health workforce which is key to expanding quality health services. And improved delivery of services needs to happen in parallel with improved financing if real progress on UHC is to be made, Dr Khetrapal Singh said. Patient safety is another area central to advancing UHC. People will not use services they think are unsafe. UHC is the hallmark of a government's commitment to improve the well-being of all its citizens. Progress towards UHC will be gradual, but it is possible from any starting point. Though countries in the Region have been making efforts, a lot more needs to be done, Dr Khetrapal Singh said. UHC is a priority area for WHO support to countries in South-East Asia Region in the coming years. ]]> <![CDATA[IAVI, CureVac partner to accelerate development and testing of AIDS vaccine candidates]]> https://biospectrumindia.com/news/95/6753/iavi-curevac-partner-to-accelerate-development-and-testing-of-aids-vaccine-candidates.html https://biospectrumindia.com/news/95/6753/iavi-curevac-partner-to-accelerate-development-and-testing-of-aids-vaccine-candidates.html Mon, 14 Sep 2015 10:41:54 +0530 The non-profit International AIDS Vaccine Initiative (IAVI) and biopharmaceutical company CureVac are partnering to accelerate the development of AIDS vaccines, utilizing novel immunogens developed by IAVI and partners, delivered via CureVac's novel messenger. The same was announced on September 11, 2015 at New Delhi. HIV's envelope protein or "trimer" is the primary target for antibodies that can neutralize a wide range of the virus' strains, and which hold enormous promise in the quest for efficacious and broadly applicable AIDS vaccines. In a major breakthrough, researchers have recently designed immunogens that successfully mimic this trimer. In this collaboration, IAVI has selected one of its leading HIV trimer constructs to launch the mRNA evaluation in small-scale clinical trials: mRNA that encodes for the chosen trimer mimic will be constructed using CureVac's RNActive® technology and injected with the aim of stimulating the body to produce HIV trimer proteins and then related neutralizing antibodies. To date, most AIDS vaccine candidates have been based on DNA, viral vectors or protein. Using mRNA could accelerate the development and testing of AIDS vaccine candidates. "This collaboration could be a real game-changer," said IAVI Chief Scientific Officer Wayne Koff. "The development of vaccines that can generate neutralizing antibodies against HIV is a top priority for IAVI and many other researchers. Researchers at IAVI's Neutralizing Antibody Center at The Scripps Research Institute and elsewhere have designed several novel immunogens that have the potential to elicit such antibodies. We are very hopeful that using mRNA will enable us to develop and test these immunogens comparatively quickly, saving both time and money." "IAVI is an ideal partner to bring highly innovative HIV vaccine designs into human testing," said CureVac co-founder and CEO Ingmar Hoerr. "We are excited to benefit from IAVI's expertise in AIDS vaccine development, and its network and experience across the United States, Europe, Africa and India and to accelerate such development on the basis of our RNActive® technology." CureVac is pioneering the use of natural and chemically unmodified mRNA as a data carrier to instruct the human body to produce proteins capable of fighting a wide range of diseases. CureVac's mRNA- based vaccine candidates are also thermostable, which eliminates the need for cold-chain storage and infrastructure that pose a major challenge in vaccine supply in developing countries. Under the terms of the agreement, IAVI will provide several stabilized HIV envelope trimer sequences, which CureVac will transfer into its RNActive® technology for preclinical and clinical development. The partners will work with U.S., German and African health authorities with an eye to initiating clinical trials in India. ]]> <![CDATA[India continues to retain high disease burden: Global Report]]> https://biospectrumindia.com/news/95/6720/india-continues-to-retain-high-disease-burden-global-report.html https://biospectrumindia.com/news/95/6720/india-continues-to-retain-high-disease-burden-global-report.html Mon, 14 Sep 2015 10:37:49 +0530 Fewer Indians are having health loss from ailments associated with childhood under nutrition and unsafe water sources, but more Indians are having health loss from diseases attributable to high blood pressure, high blood sugar and high cholesterol according to a new analysis of 79 risk factors in 188 countries. "Global, regional, and national comparative risk assessment of 79 behavioral, environmental and occupational, and metabolic risks or clusters of risks in 188 countries 1990-2013: a systematic analysis for the GBD 2013" examines the extent, pattern, and trends of risk factors' contributions to death and health loss across countries. Published in The Lancet on September 11, 2015, the study was conducted by an international consortium of researchers working on the Global Burden of Disease (GBD) study, including from the Public Health Foundation of India (PHFI), and led by the Institute for Health Metrics and Evaluation (IHME) at the University of Washington. The study examines which risk factors contribute to health loss as well as death. Researchers used DALYs, or disability-adjusted life years, to measure overall health loss. One DALY equals one lost year of healthy life. DALYs are measured as the sum of years of life lost due to early death and years of healthy life lost due to disability. "It is remarkable that the contribution of metabolic risk factors such as high blood pressure, blood sugar and cholesterol, and that of poor diet and alcohol use, to health loss has doubled in India over the past quarter of a century," said study co-author Dr Lalit Dandona who is Professor at PHFI and IHME and who led the work of this study in India. "Metabolic risk factors that include high blood pressure, blood sugar and cholesterol, along with unhealthy dietary habits and smoking are responsible for about 5.2 million premature deaths in India every year," said Dr K Srinath Reddy who is President of PHFI and member of the GBD Scientific Council. "This trend will continue to increase unless effective prevention strategies to address these risk factors are implemented in India rapidly." "Since 1990, Improvements in unsafe water sources and sanitation, and in under nutrition of children and mothers, have reduced their contribution to the disease burden in India but these risk factors continue to be significant contributors to ill health. High blood pressure, high blood sugar and indoor air pollution are the leading causes of health loss in India at present," said Dr Soumya Swaminathan who is director-general of the Indian Council of Medical Research. "Further multi-disciplinary and cross-sectoral action is essential in India to minimize the continuing burden caused by these risk factors. Behavioral and social science research will play an increasingly important role." High blood pressure, high blood sugar and household air pollution from solid fuels were estimated to cause 7.8 percent, 5.2 percent and 4.7 percent of the total health loss in India in 2013, respectively. These three risk factors together contributed to 3.3 million premature deaths in India in 2013. The other major contributors to health loss in India are unsafe water sources, tobacco smoking, alcohol use, high blood cholesterol and outside air pollution. The contribution of unsafe water sources and poor sanitation, as well as child and maternal under nutrition, to health loss have dropped significantly since 1990, but these are still substantial contributors to health loss in India. "Air pollution inside the home due to use of solid fuels as well as outdoor air pollution have continued to be major contributors to ill health and premature deaths in India for over two decades," said study co-author Dr Kalpana Balakrishnan, who is Professor and Director of WHO Collaborating Center for Occupational and Environmental Health at Sri Ramachandra University. "The findings from this study highlight the need to develop integrated approaches to reduce air pollution in both rural and urban populations." India is part of a global landscape with tremendous regional variations. In much of the Middle East and Latin America, high body mass index is the number-one risk associated with health loss. In South and Southeast Asia, household air pollution is a leading risk, and India also grapples with high risks of unsafe water and childhood undernutrition. Alcohol is the number-two risk in Russia, and smoking is the number-one risk in many high-income countries, including the United Kingdom. The most marked differences are found in sub-Saharan Africa, which, unlike other regions, is dominated by a toxic combination of childhood undernutrition, unsafe water and sanitation, unsafe sex, and alcohol use. "There's great potential to improve health by avoiding certain risks like smoking and poor diet as well as tackling environmental risks like air pollution," said IHME Director Dr. Christopher Murray who leads the GBD study globally. "The challenge for policymakers will be to use what we know to guide prevention efforts and health policies." ]]> <![CDATA[DBT sets up target of $110 billion big biotech sector by 2025 ]]> https://biospectrumindia.com/news/95/5092/dbt-sets-up-target-of-110-billion-big-biotech-sector-by-2025-.html https://biospectrumindia.com/news/95/5092/dbt-sets-up-target-of-110-billion-big-biotech-sector-by-2025-.html Fri, 11 Sep 2015 14:06:47 +0530 As per DBT, the targeted mission is to accelerate the pace of growth of biotechnology sector to achieve a target of $110 billion by 2025. In response to questions from management and social sector experts on perceptible and measurable strategies of DBT over the next couple of years, Dr K Vijay Raghavan, secretary, DBT underlined that biotech will see at least a 20 percent increase in new companies, 20 percent more biotech incubators, 20 percent more social-sector partnerships, and 20 percent more Med-tech devices each year over the next three years Dr Raghavan further stated that the results from stem-cell research will see impact on Sickle-cell anemia and Thalassemia treatments in three years. The work on maternal health, pre-term birth and stunted growth will result in significant improvement in nutrition and anemia treatment - programs for women within 2-3 years. India will establish a substantial presence in genome engineering and computational biology in coming three years. "Mapping of the biodiversity of our islands and the coral reefs will be completed next year from which drug discovery centres will have access to novel compounds in two years. Major international collaborations will be established this year and the next following high-level exchanges with Japan (Stem-cells), France (Marine Biology) Canada (Stem cells), Netherlands (Vaccines), UK (Agri-plant), Netherlands (vaccines), US (Energy, Vaccines)," outlined the secretary DBT while addressing the directors, senior faculty and officers present on the occasion. The concluding session of the strategy meet agreed to focus on: Building a skilled workforce and leadership. Encouraging basic and discovery research and connecting this to our society. Nurturing innovation, translation and entrepreneurship to transform our society. Ensuring a transparent and globally best regulatory environment. Building and fostering partnerships both at National and International level. It was also agreed that for effective implementation of these strategic decisions it is important that we create a matrix of the measurements of process as well as outcome. Key missions are also being formulated by the DBT to address major national challenges on healthcare, energy, food security and human resource. These steps by the premier biotech agency in its 30th year will surely bear fruits in next one decade. ]]> <![CDATA[DBT plans new strategies to boost biotech industry]]> https://biospectrumindia.com/news/95/6751/dbt-plans-new-strategies-to-boost-biotech-industry.html https://biospectrumindia.com/news/95/6751/dbt-plans-new-strategies-to-boost-biotech-industry.html Fri, 11 Sep 2015 13:58:16 +0530 As per a circular by the department of biotechnology, ministry of science and technology, government of India, the premier biotech agency is completing 30 years and will be celebrating its 30th Foundation Day in February, 2016. Therefore, the DBT felt appropriate at this point to assess and analyze in consultation with all stake-holders the 4P's- Progress, Promises, Problems and Plans for future. In this connection a strategy meet was organized on August 31, 2015 at NCR Biotech Science Cluster, Faridabad. The minister of science and technology, Dr Harsh Vardhan presided over the meeting. The meeting was attended by the directors and senior faculty of DBT aided autonomous institutes and other senior experts across the country. Besides that, the members of the civil society, secretary and all officers of DBT were present. Strategies for boosting biotech industry, stem cell research, genome engineering, computational biology and drug discovery were outlined at the this strategy meet on biotechnology. In his opening address, Dr K Vijay Raghavan, secretary, DBT gave an overview and detailed assessment of the impact over the years and highlighted how DBT has contributed significantly through its efforts towards supporting key missions, spear heading cutting edge research, building Institutional and human resource capacity, forging industry academic partnership, leveraging international strength through collaborations and guiding policy thinking and analysis. Dr Harsh Vardhan in his inaugural address highlighted the importance of Biotechnology Sector to contribute to the society. He said that it would be important to develop a new sense of urgency and work towards preparing an action plan and address key strategies for the future to deliver perceptible and measurable impact for the benefit of society. The minister also stated that the biotechnology sector which has an important role and cuts across all other sectors, takes forward its strategy in partnership with other S&T ministry, departments and state governments. He appreciated the good work that DBT is doing in taking forward Biotechnology Research in the country and stressed the necessity to fix 3 to 4 focus areas with achievable targets in the next 2 to 3 years. He outlined malnutrition as one of the key focus areas elaborating that whereas there has been much research on nutrition, the research needed to be translated to yield benefits for people. Dr Vardhan highlighted that while the overall strategy of the DBTwas clear, each institution and each unit of DBT should have measurable targets over the next couple of years. In the presentations made by the directors of DBT autonomous institutions and other experts a broad overview of various thematic areas was presented highlighting specifically where we stand vis-Ã -vis the global scenario, the challenges faced and future action plan. ]]> <![CDATA[Suven secures five new patents]]> https://biospectrumindia.com/news/95/6596/suven-secures-five-new-patents.html https://biospectrumindia.com/news/95/6596/suven-secures-five-new-patents.html Fri, 11 Sep 2015 12:09:26 +0530 Suven Life Sciences Ltd (Suven) announces the grant of one (1) product patent from China (CN 102869647), one (1) product patent from Israel (220709), one (1) product patent from Mexico (329382), one (1) product patent from Singapore (181992) and one (1) product patent from Sri Lanka (15412) corresponding to their New Chemical Entities (NCEs) for the treatment of disorders associated with Neurodegenerative diseases. The granted claims of the patents include the class of selective 5-HT compounds discovered by Suven and are being developed as therapeutic agents and are useful in the treatment of cognitive impairment associated with neurodegenerative disorders like Alzheimer's disease, Attention deficient hyperactivity disorder (ADHD), Huntington's disease, Parkinson and Schizophrenia. With these new patents, Suven has a total of seventeen (17) granted patents from China, seven (7) granted patents from Israel, twenty (20) granted patents from Mexico, twenty one (21) granted patents from Singapore and eleven (11) granted patents from Sri Lanka. These granted patents are exclusive intellectual property of Suven and are achieved through the internal discovery research efforts. Products out of these inventions may be out-licensed at various phases of clinical development like at Phase-I or Phase-II. "We are very pleased by the grant of these patents to Suven for our pipeline of molecules in CNS arena that are being developed for cognitive disorders with high unmet medical need with huge market potential globally," said Mr Venkat Jasti, CEO of Suven. ]]> <![CDATA[Serum partners with the US based Visterra]]> https://biospectrumindia.com/news/95/6633/serum-partners-with-the-us-based-visterra.html https://biospectrumindia.com/news/95/6633/serum-partners-with-the-us-based-visterra.html Fri, 11 Sep 2015 12:08:27 +0530 Visterra and Serum Institute of India (Serum Institute) has announced that the companies have entered into a license agreement for the development, manufacture and commercialization of VIS513 in the Indian subcontinent countries. VIS513 is Visterra's humanized monoclonal antibody that was designed to bind and potently neutralize all four serotypes of dengue virus and was engineered using Visterra's innovative and proprietary Hierotope technology. Preclinical studies of VIS513 have demonstrated a rapid reduction in viral titers after a single systemic administration, which supports its continued development as a single administration for the treatment of dengue virus infection. Under the terms of the agreement, Serum Institute receives an exclusive license to VIS513 for the Indian subcontinent, including India, Pakistan, Bangladesh, Nepal, Bhutan, Maldives, and Sri Lanka. Serum Institute will pay Visterra a $ 5 million upfront payment, plus up to US$ 34 million based on the achievement of certain development and commercial milestones. Additionally, once VIS513 is commercialized, Visterra will be eligible to receive tiered, double-digit royalties based on net sales in the licensed territories. Serum Institute will fund and be responsible for the clinical development of VIS513 in the licensed territories, including the filing of regulatory applications. The companies will establish a joint steering committee primarily to coordinate VIS513 development activities for the Indian subcontinent with the global development strategy. Following regulatory approval, Serum Institute will be responsible for commercializing VIS513 in the licensed territories. "We believe that VIS513 is a promising novel monoclonal antibody being developed for the treatment of dengue, which is a major healthcare concern to India and surrounding countries. We are excited to take on this important role to advance the development of a potential treatment that could address a significant unmet medical need," said Mr Adar Poonawalla, CEO, Serum Institute. He added, "This collaboration further strengthens our pipeline of innovative biologics and we look forward to working closely with Visterra and its talented team." "An important goal for us is to provide a therapeutic option as quickly as possible for patients with dengue, as there is currently no specific treatment and disease prevention is solely dependent on limiting or eradicating mosquitoes that transmit the virus. We believe that we can best fulfill this goal in the Indian subcontinent by pursuing the development of VIS513 with Serum Institute," said Dr Brian J. G. Pereira, president and chief executive officer of Visterra. He added, "Serum Institute has a proven track record in developing novel biological products and expansive commercialization capabilities in the Indian subcontinent, which makes them the ideal partner." ]]> <![CDATA[Cole-Parmer expands fluid handling and analysis products biz]]> https://biospectrumindia.com/news/95/6291/cole-parmer-expands-fluid-handling-and-analysis-products-biz.html https://biospectrumindia.com/news/95/6291/cole-parmer-expands-fluid-handling-and-analysis-products-biz.html Thu, 10 Sep 2015 17:39:13 +0530 With the recent acquisition of Ismatec pumps from IDEX Health and Science, Cole-Parmer has expanded its fluid handling and analysis products business. The independent channel control (ICC) pumps provide lower pulsation, better reproducibility, and a longer tubing life. Variable flow and bidirectional capabilities in each channel add to their flexibility. The uniqueness of the ICC allows for individual channel calibration. A much desired feature-computer compatibility-enables users to monitor the pumps remotely, make adjustments, and gather and analyze measurement data. Ismatec pumps are ideal for dissolution testing in pharmaceutical dosing, chromatography applications, the addition of a reagent to a reactor, and a variety of research and development purposes. Single-channel Ismatec Reglo Quick pumps offer quick tubing changes while Flowmaster pumps are designed for heavy-duty processes and increased hygienic requirements. "I'm very excited about this acquisition as Ismatec expands our depth of micro flow products complementing our Masterflex Product Line. Ismatec has unique pump heads which reduces damage to cells, useful in biotech applications. Reglo ICC, is another unique potential multichannel pump in which each channel has variable flow adjustment." - said Rakesh Aggarwal, Managing Director - Asia Pacific, Cole-Parmer. ]]> <![CDATA[Tamil Nadu supports TICEL Bio Park II with Rs 168 crores]]> https://biospectrumindia.com/news/95/4776/tamil-nadu-supports-ticel-bio-park-ii-with-rs-168-crores.html https://biospectrumindia.com/news/95/4776/tamil-nadu-supports-ticel-bio-park-ii-with-rs-168-crores.html Thu, 10 Sep 2015 10:58:26 +0530 Inaugurating the Tamil Nadu's first ever Global Investors Meet in Chennai, Chief Minister Selvi J Jayalalithaa said the target of Rs 100,000 crore of investment commitment has been exceeded. The two-day Tamil Nadu Global Investors Meet (TNGIM) 2015 took off with a grand start amid much optimism and cheer as the State received investment commitments in excess of Rs 100,000 crore even before the meet formally commenced. TNGIM is being organized with an objective to showcase the strengths of and opportunities in the state for potential investors across the globe and to invite them to participate in the state's progress towards inclusive growth and prosperity. The two-day meet from September 9 to 10, 2015 was inaugurated by Tamil Nadu Chief Minister J Jayalalithaa. She was joined by the Minister of State for Commerce and Industry Ms Nirmala Sitharaman, Minister of State for Surface Transport, Highways and Shipping Mr Pon Radhakrishnan, Minister for Industries and Transport for Tamil Nadu Mr P. Thangamani, Ambassadors and High Commissioners of various countries, and delegates from India and abroad. Expressing satisfaction over the response among prospective investors, the Chief Minister Jayalalithaa said, "We have already crossed our initial investment target of Rs 100,000 Crore. We expect more MoUs to be signed during the meet. Invest in Tamil Nadu. Invest in our shared future." The Tamil Nadu Chief Minister also inaugurated three major industrial projects with a total investment of Rs 2,658 crore. This included India Yamaha Motor along with 9 vendor units putting in Rs 1,600 crore for a new 2-wheeler plant in Kancheepuram district with a capacity of 1.8 million units per annum, the TICEL Bio Park II at Taramani built at a cost of Rs 168 crore, and the expansion of TVS Motor Company at Hosur with an investment of Rs 800 crore. TNGIM 2015 features a total of 25 seminars, specific to attending countries and industry, such as automotive, it hardware, agro, pharma and biotech, textiles, among others. A total of 348 exhibitors are participating at the meet. Tamil Nadu is the most urban state in India, with close to half the state's population living in cities, sustained by the state's stable governance and enviable infrastructure that includes the second highest power generation capacity in the country, 20 industrial parks and 78 special economic zones for business and three international airports for global connectivity. HCL chairman Shiv Nadar, in his speech at TNGIM, announced the company's intent to allocate $1 billion of investments around Madurai in southern Tamil Nadu. Over the next two days, TNGIM shall bring together policymakers, industry experts, state institutions and entrepreneurs to deliberate on the future growth strategy. The nine partner countries are Australia, Canada, France, Japan, Italy, Russia, Republic of Korea, Singapore and the United Kingdom. The State Government is being assisted by national trade bodies such as Assocham, CII, FICCI and international organizations such as JETRO, KOTRA, MIBC and UK India Business Council. ]]> <![CDATA[Micro Labs aggressive on entering US markets]]> https://biospectrumindia.com/news/95/7395/micro-labs-aggressive-on-entering-us-markets.html https://biospectrumindia.com/news/95/7395/micro-labs-aggressive-on-entering-us-markets.html Wed, 09 Sep 2015 18:11:16 +0530 Today, the company formally launched Caripill, a pill which is said to increase the platelet count in patients suffering from Dengue. The pill has already been made available in the market since July 2015, but was formally launched today in the presence of media delegates. The pill has been completely developed in-house by Micro Labs, and has taken two years in the making including the clinical trials, the company told BioSpectrum. The newly launched pill is made from Carica Papaya Leaf extract, and is sold at Rs 25 per pill with a dosage of one pill taken thrice in a day. "It does not have any side-effects," Micro Labs said. Dengue is a mosquito-borne viral infection spread by day-biting mosquitoes, and is said to be the leading case of serious illnesses and death among children in some Asian and LatAm countries. According to WHO, globally, 2.5 billion people are at risk of Dengue infection. "The number of Dengue cases is more than what is publicly reported by the Media. It is 300 times more than official figures," pointed Dr Nagabhushan K H, VP, medical services, Micro Labs. The severity of Dengue is determined by the increased destruction or decreased production of platelets in the blood. The company said that Caripill has been approved by the Department of Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homoeopathy (AYUSH). There are 4 distinct types of viruses that causes Dengue: DEN-1 (prevalent in Mumbai); DEN-2 (prevalent in Bangalore); DEN-3 (prevalent in Mumbai & Delhi); and DEN-4. The currently available methods for treating Dengue includes platelet transfusion, and similar drugs manufactured and imported into India by pharma giants GSK and Amgen. Platelet transfusion usually require multiple sessions, each costing Rs 15,000. GSK's Revolade (Eltrombopag) is priced at Rs 27,000 per month and Amgen's Nplate (Romiplostim) could cost more than a lakh rupees for a few vials. New Delhi's pharma company Sanat Products manufactures Uplat, a capsule made of Tinospora Cordifolia extract, designed to naturally boost platelet count in the blood. Chennai-based pharma company Brio Bliss Life Science makes a syrup from Carica Papaya Leaf extract, which is said to increase platelet levels within 72 hours. Micro Labs also plans to launch Caripill syrup for pediatric patients in another 10 days. The clinical trials for Caripill was conducted in 300 patients in Bangalore, Hyderabad, Visakhapatnam, Bhubaneshwar, and Srikakulam. Mr Vineet Kalia, executive VP, strategy & BD, Micro Labs, said that Caripill has received an immense good response from the market. When BioSpectrum asked about Caripill's annual production projections, Mr Kalia commented, "It is very difficult to predict it at the moment." Micro Labs is a Mumbai-based privately held firm which is now under the leadership of Mr Dilip Surana and Mr Anand Surana. According to pharmaceutical market research firm AIOCD AWACS, Micro Labs occupies the 19th spot in sales in India, and it aims to touch the $1 billion mark by 2017. It is a major manufacturer of selected therapeutic areas including cardiology, diabetology, dermatology, ophthalmology and pain or analgesics. The company employs about 6000 field force. Micro Labs currently has 14 plants - 7 in Bangalore, 3 in Tamil Nadu, 1 in Pondicherry, Goa, Baddi and Sikkim. Its 2 R&D centers are located in Bangalore and Mumbai. More and more Indian pharma companies are showing increased interest in entering the US generics market. This month, Cipla acquired two US-based generic companies, InvaGen Pharmaceuticals and Exelan Pharmaceuticals, for $550 million. In July 2015, Lupin acquired US generic firm Gavis Pharma for $880 million. ]]> <![CDATA[Last two days to send comments on Human DNA Profiling bill]]> https://biospectrumindia.com/news/95/7042/last-two-days-to-send-comments-on-human-dna-profiling-bill.html https://biospectrumindia.com/news/95/7042/last-two-days-to-send-comments-on-human-dna-profiling-bill.html Wed, 09 Sep 2015 17:12:34 +0530 Given the huge population of India and the repercussions of unregulated profiling of human Deoxyribose Nucleic Acid (DNA) by numeruous laboratories, the DBT under union science and technology ministry has come up with the 37 page draft of the national 'Human DNA Profiling Bill 2015'. Under the same, it is looking at establishing the DNA Profiling Board that will look into the regulations of DNA profiling. The Board will lay down the standards for the laboratories, collection of human body substances, custody trial from collection to reporting and also to establish the National DNA Data Bank for matter connected therewith or incidental thereto. Since, there has been a good response to the DBT's earlier circular seeking comments on the bill from various stakeholders, it has now extended the deadline to send the same by September 10, 2015 upto 5:30 PM. Once the draft is finalized after final consultations, it will be then eventually tabled in the Parliament by government for further discussions and approval by lawmakers. The Human DNA Profiling Act 2015 as it would be called, has jurisdiction over entire country and will be enforced through Gazette notification by the central government once ratified by the Parliament. ]]> <![CDATA[WHO calls for urgent action to prevent return to pre antibiotic era]]> https://biospectrumindia.com/news/95/6386/who-calls-for-urgent-action-to-prevent-return-to-pre-antibiotic-era.html https://biospectrumindia.com/news/95/6386/who-calls-for-urgent-action-to-prevent-return-to-pre-antibiotic-era.html Wed, 09 Sep 2015 17:08:34 +0530 "Immediate action is needed to stop the world from heading towards pre-antibiotic era in which all achievements made in prevention and control of communicable diseases will be reversed. Common infections and minor injuries which have been treatable for decades may once again kill millions. Resistance to antibiotics will make complex surgeries and management of several chronic illnesses like cancer, extremely difficult," Dr Poonam Khetrapal Singh, regional director of WHO South-East Asia Region, said at a regional meeting in Dili, the capital of Timor-Leste. Already, without effective antimicrobial medicines, a number of common infections such as hospital acquired ventilator associated pneumonias, urinary tract infections; diarrhea, gonorrhea, tuberculosis, malaria etc. are becoming harder to treat. The problem is compounding, and unless we act now, the consequences might be irreversible, Dr Khetrapal Singh said. A recent forecast of the potential human and economic cost estimates 10 million deaths per year globally and 2 to 3.5 percent less global gross domestic product by 2050 if antimicrobial resistance goes unchecked. Reduced productivity from persisting illness, and its cost of treatment, add to the economic loss. The Regional Director was addressing health ministers and senior health ministry officials from the 11 Member countries of WHO South-East Asia Region, at the Sixty-eighth meeting of the Regional Committee which meets annually to discuss health priorities and health agenda for the Region. Dr Khetrapal Singh said comprehensive and integrated national action plans are needed to respond to antimicrobial resistance. Countries need to strengthen monitoring of the extent and cause of antibiotic resistance, improve infection control in hospitals and regulate and promote appropriate use of medicines. Increased awareness needs to be created among the general public as well as health workers and pharmacists on taking/selling only prescribed medicines and completing its full course.WHO South-East Asia regional strategy, the Jaipur Declaration on Antimicrobial Resistance, 2011 and the recent Global Action Plan need to be implemented in totality, keeping in mind national priorities and context, to prevent and contain antimicrobial resistance. The current global antibiotic resistance has resulted from injudicious rampant use of antibiotics by prescribers, patients not completing full treatment courses, over-use of antibiotics in livestock and fish farming, poor control of infections in health care settings and poor hygiene. There are not many new antibiotics in the pipeline that can replace the resistant and ineffective ones. "Antibiotics are a precious resource. They have saved millions of lives by treating serious infections. Everyone has a role to play in preserving their effectiveness, together we can stop this potential threat," Dr Khetrapal Singh stated. ]]> <![CDATA[AZ sign bioinformatics pact with Manchester Uni]]> https://biospectrumindia.com/news/95/6787/az-sign-bioinformatics-pact-with-manchester-uni.html https://biospectrumindia.com/news/95/6787/az-sign-bioinformatics-pact-with-manchester-uni.html Wed, 09 Sep 2015 12:18:13 +0530 AstraZeneca and The University of Manchester has announced a collaboration harnessing clinical bioinformatics to deliver personalised healthcare for cancer patients. The five-year agreement will see the organisations apply clinical trial bioinformatics to better identify the right cancer treatment for the right patient at the right time. As part of the collaboration, AstraZeneca will provide a total of £11.5 or (approx. $17.70million) million to support clinical bioinformatics research led by a dedicated team of investigators within the recently established Centre for Cancer Biomarker Sciences at the Manchester Cancer Research Centre. The research will be carried out in partnership with the state-of-the-art clinical trials unit of The Christie NHS Foundation Trust, which is at the forefront of experimental cancer medicine in the UK. Projects will include the development of a new bioinformatics system to capture and integrate clinical trial safety, efficacy, biomarker and drug distribution data in real time, presenting the information in the form of graphs that can be easily interpreted by clinicians to help tailor the treatment for patients. The collaboration will also support new training programmes in clinical research and pharmacokinetic and pharmacodynamic modelling for investigators to understand the distribution and clinical effects of medicines within the body. Mr Mene Pangalos, executive vice-president, Innovative Medicines & Early Development, said, "This collaboration is exciting because it will eventually allow us to incorporate important data from clinical trials into a format that can be reviewed in real time by healthcare professionals and matched with information about cancer medicines. We will be able to modify clinical trial programmes accordingly and support clinicians to offer more accurate, personalised and rapid decision making to patients about their treatment." Professor of Experimental Cancer Medicine, Andrew Hughes, from the University's Institute of Cancer Sciences said, "Patient insight is key to our understanding of new cancer drugs. The information we get from patients about their experiences of taking new drugs is key to shaping our risk and benefit assessment. AstraZeneca has long supported the UK science base and this latest collaboration with the Manchester Cancer Research Centre will enable the patients to share their insights with investigators and sponsors more effectively and efficiently than today, enabling a more informed assessment." This collaboration builds on existing scientific collaborations between AstraZeneca and The University of Manchester, ranging from research into novel cancer medicines to progressing treatments for lung cancer, advancing inflammatory research and developing new drug delivery systems. ]]> <![CDATA[CICR to support TNAU's indigenous Bt cotton research]]> https://biospectrumindia.com/news/95/6542/cicr-to-support-tnaus-indigenous-bt-cotton-research.html https://biospectrumindia.com/news/95/6542/cicr-to-support-tnaus-indigenous-bt-cotton-research.html Wed, 09 Sep 2015 12:17:45 +0530 Tamil Nadu Agriculture University (TNAU) and Central Institute for Cotton Research (CICR) have entered into agreement for developing indigenous Bt Cotton. According to the press release, TNAU has already developed a potent Bt gene and using this gene, cotton that is resistant to the boll worms were produced. TNAU in collaboration with CICR in Nagpur will further work on the development of this indigenous Bt cotton. The MoU was signed by Dr. S. Ayyappan, Secretary (DARE) & Director General, ICAR, New Delhi; Professor K. Ramasamy, Member, State Planning Commission; Dr. C. R. Anandakumar, Acting Vice-Chancellor, TNAU and Dr. N. Gopalakrishnan, Principal Scientist, CICR Regional Station, Coimbatore. The scientists explained that Bollworm infestation is a serious problem causing enormous yield loss in cotton. Farmers are forced to take up frequent insecticidal sprays. Conventional breeding to develop bollworm resistant cotton is difficult due to non-availability of resistance source in cultivated cotton. With the advent of recombinant DNA and genetic transformation technology, it is possible to introduce a specific gene from a soil bacterium into cotton plant. This gene expresses a Bt protein which has insecticidal activity against the bollworms. ]]> <![CDATA['PfizerKline' is just a speculation: GSK ]]> https://biospectrumindia.com/news/95/6724/pfizerkline-is-just-a-speculation-gsk-.html https://biospectrumindia.com/news/95/6724/pfizerkline-is-just-a-speculation-gsk-.html Tue, 08 Sep 2015 17:06:00 +0530 GSK today held its groundbreaking ceremony for its upcoming new manufacturing pharma facility near Bangalore, in Kolar, with an investment of Rs 1000 crore (£100 million). For this, the Government of Karnataka has allotted 50 acres of Karnataka Industrial Area Development Board (KIADB) land at Vemgal Industrial Area located in Kolar, 50km to the east of Bangalore. It is expected to manufacture 8 billion tablets and 1 billion capsules relating to gastroenterology and anti-inflammatory medicines primarily for the Indian market. The first production batches will begin by the end of 2016. Initially the facility will supply solid dose formulation products. The factory will employ 300 professionals, and Mr James Hogg, who is the Indian head of the GSK pharma factory, will also be in-charge of the project. The facility will be GSK's first Greenfield pharmaceutical site across the globe in the last 10 years. According to GSK's media release, the plant will use over half a megawatt of solar generated power with all waste water being recycled. The foundation stone at the site was laid by Hon'ble CM of Karnataka, Shri Siddaramaiah along with Lord Francis Maude, Hon'ble UK minister of State for Trade and Industry. Speaking on the occasion, Mr Annaswamy Vaidheesh, VP, South Asia & MD, India, commented that the facility will further expand as opportunities arise. "We have our project schedule with various aspects to it. The first construction will begin next month, and we are in the process of getting the experts. This is also a part of our long-term commitment to India. This facility is meant for the Indian market. Later, as we move forward, products from this plant will be supplied to other markets. The Karnataka's CM has assured us of all the necessary infrastructure." Mr Vaidheesh took up his new role with GSK in June 2015. According to GSK, the city of Bangalore was selected because of its recognized status as a pharma and biotech hub, availability of skilled staff, moderate climate, easy accessibility and the support from the Government of Karnataka. Companies from Japan, Taiwan, German and French have shown big interest in investing in Karnataka, revealed Shri Siddaramaiah. Lord Francis said that this investment will help attract other pharma companies to invest in Karnataka. "In the last 50 years, British companies have invested more in India than in any other G20 nations. Britain responded to Indian PM's 'Make in India' initiative by launching great collaboration in January this year. These collaborations are of mutual benefit across a range of sectors enabling success for both the parties," he said. Indian Life Sciences companies like Dr Reddy's, Strides Arcolab, Cipla, and Strand Life Sciences have strong presence in the UK. GSK so far has 84 manufacturing sites in 36 countries and employs 98,000 professionals in 100 countries with more than a third from the emerging markets. Talking about the competition between MNC companies versus local players in the Indian market, Mr Vaidheesh pointed, "There is definitely a big market for MNC brands in India because local brands have their specific segments which they occupy. We are not much worried about the local players. We believe in knowledge transfer. We have other strategies to work alongside local players. We are committed to growing rapidly as fast as other MNC pharma companies and be with the market, or beat the market." When asked about the possibility of GSK merging with Pfizer (PfizerKline), Mr Vaidheesh added, "Rumors continue to happen because the companies are large pharmas. GSK is a big organization and it has well-articulated future plans with respect to pharma and consumer segments. This is just a speculation." ]]> <![CDATA[Rejected: Pfizer's patent application for RA drug]]> https://biospectrumindia.com/news/95/3668/rejected-pfizers-patent-application-for-ra-drug.html https://biospectrumindia.com/news/95/3668/rejected-pfizers-patent-application-for-ra-drug.html Tue, 08 Sep 2015 17:02:21 +0530 The authorities said that it did not enhance the efficacy of the existing approved drug. "After having considered the submissions submitted by the applicant in the hearing, the written submission and amended claims filed... it is hereby ordered that the invention disclosed and claimed in the instant application... is not considered as an invention under the provisions of the Act," said Mr Bharat N S, Assistant Controller of Patents and Designs, in an order. He added, "I do not admit that the claimed compound has enhanced efficacy over the base compound...and hence not patentable under Section 3(d) of Patents Act... and I therefore, hereby refuse this Application." Quoting a Supreme Court judgement, the order said that the applicant would have to establish the therapeutic enhanced efficacy of the claimed compound over the base compound. This is the second time that the authorities have rejected the company's patent application. In October last year, the Intellectual Property Appellate Board (IPAB) set aside an order by the patent office which rejected Pfizer's patent for a new formula of the drug and directed it to re-consider the application. ]]> <![CDATA[Novartis receives EU approval for cancer drug,Farydak]]> https://biospectrumindia.com/news/95/6397/novartis-receives-eu-approval-for-cancer-drugfarydak.html https://biospectrumindia.com/news/95/6397/novartis-receives-eu-approval-for-cancer-drugfarydak.html Tue, 08 Sep 2015 11:58:30 +0530 Novartis has announced that the European Commission has approved Farydak (panobinostat, previously known as LBH589) capsules, in combination with bortezomib and dexamethasone, for the treatment of adult patients with relapsed and/or refractory multiple myeloma who have received at least two prior regimens including bortezomib and an immunomodulatory agent (IMiD). Multiple myeloma is a cancer of the plasma cells, a type of white blood cell present in the bone marrow, and affects approximately 84,000 people in Europe. Farydak is the first HDAC inhibitor to show efficacy in multiple myeloma. As an HDAC inhibitor, its epigenetic activity may help restore cell function in patients with multiple myeloma. The EU approval of Farydak is based on efficacy and safety data in a subgroup analysis of 147 patients who had received at least two prior regimens, including bortezomib and an IMiD, during the Phase III, randomized, double-blind, placebo-controlled, multicenter global registration trial, called PANORAMA-1 (PANobinostat ORAl in Multiple MyelomA), evaluating Farydak in combination with bortezomib and dexamethasone against bortezomib and dexamethasone alone in patients with relapsed and/or relapsed and refractory multiple myeloma. The trial found that the median progression-free survival (PFS) benefit in this subgroup increased by 7.8 months in Farydak patients who had received prior treatment with both bortezomib and an IMiD (12.5 months; n=73), as compared to the placebo arm (4.7 months; n=74) (hazard ratio=0.47 [95% confidence interval (CI): 0.31, 0.72]). The most common non-hematological adverse reactions included diarrhea, fatigue, nausea and vomiting. Treatment-emergent hematological toxicities included thrombocytopenia, anemia, neutropenia and lymphopenia. "With the approval of Farydak in the European Union, we hope to address critically important treatment needs faced by the multiple myeloma community-disease progression and treatment resistance. This milestone, the approval of a first in its class treatment option for patients in need of new therapies, is the result of more than 13 years of dedicated research, which has helped us better understand the development of multiple myeloma,"said Ms Bruno Strigini, president, Novartis Oncology. Farydak in combination with bortezomib and dexamethasone is also approved in the US, Chile and Japan for certain patients with previously treated multiple myeloma. ]]> <![CDATA[Starpharma signs drug delivery license with AstraZeneca]]> https://biospectrumindia.com/news/95/6276/starpharma-signs-drug-delivery-license-with-astrazeneca.html https://biospectrumindia.com/news/95/6276/starpharma-signs-drug-delivery-license-with-astrazeneca.html Tue, 08 Sep 2015 11:56:58 +0530 Starpharma has announced the signing of a licensing agreement with global pharmaceutical company AstraZeneca. The agreement enables the development and commercialisation by AstraZeneca of compounds directed at a defined family of targets using Starpharma's DEP drug delivery technology. The DEP platform centres on use of Starpharma's proprietary dendrimers, with the aim of enhancing the dosing and efficacy characteristics of pharmaceuticals. Under the agreement Starpharma is eligible to receive signature and milestone payments on one or more AstraZeneca DEP products if they progress through the development pipeline, and milestone and royalty payments on any net sales of the resultant products. AstraZeneca will fund all development and commercialisation costs under the agreement, including ongoing and future collaborative work conducted with Starpharma. Starpharma's other programs, including the company's wholly-owned DEP docetaxel product, are not negatively impacted by this arrangement. A signature payment of $2 million (A$2.9 million) became payable on execution of the agreement. For the initial product, development and launch milestones could total up to US$64 million (A$91 million), and sales milestones based on specified annual sales levels could total up to US$60 million (A$86 million). The license agreement allows for additional products to be incorporated, with development and regulatory milestone payments of up to US$53.3 million (A$76 million), and potential sales milestones based on specified annual sales levels for qualifying additional products could total up to US$40 million (A$57 million). Any AstraZeneca DEP products would also attract tiered royalties on net sales. "This agreement with AstraZeneca is an exciting development for Starpharma and its DEP platform. It follows a successful collaboration in which Starpharma's DEP drug delivery technology has been applied to an important AstraZeneca oncology candidate," said Dr Jackie Fairley, CEO, Starpharma. Ms Susan Galbraith, head of the Oncology Innovative Medicines Unit at AstraZeneca, said, "We already have a long-standing and successful working relationship with Starpharma. This license agreement will enable us to further harness the DEP technology and evaluate its potential across novel molecules within our oncology portfolio.'' ]]> <![CDATA[New DG of ICMR, Dr Soumya Swaminathan to focus on health priorities]]> https://biospectrumindia.com/news/95/8011/new-dg-of-icmr-dr-soumya-swaminathan-to-focus-on-health-priorities.html https://biospectrumindia.com/news/95/8011/new-dg-of-icmr-dr-soumya-swaminathan-to-focus-on-health-priorities.html Mon, 07 Sep 2015 14:34:26 +0530 The post of director general of that fell vacant after the retirement of Dr VM Katoch (in March, 2015), has finally been filled up. Government has appointed Dr Soumya Swaminathan as director general, ICMR and secretary, Department of Health Research (Ministry of Health & Family Welfare) with effect from August 17, 2015. Her appointment is for the three years until further orders, mentioned the official circular. She brings with her, the vast experience in health research and research administration. Prior to this assignment, Dr Soumya Swaminathan was director, National Institute for Research in Tuberculosis (NIRT) in Chennai since 2012. She also happens to be the daughter of famous scientist and father of India green revolution, Dr M S Swaminathan. She herself is a renowned figure in the field of medicine. After completing her MBBS from AFMC, Pune and MD in Pediatrics from AIIMS, New Delhi, further training included a Fellowship in Neonatology and Pediatric Pulmonology at the Children's Hospital of Los Angeles, University of Southern California, USA and a Research Fellowship in the Dept. of Pediatric Respiratory Diseases, University of Leicester, UK. She joined the Tuberculosis Research Centre, Chennai in 1992 and has spent the past 23 years in health research. Her research interests include pediatric and adult tuberculosis, epidemiology and pathogenesis, the role of nutrition and HIV-associated TB. She also served for 2 years as Coordinator, Neglected Tropical Diseases at TDR. She holds many professional memberships such as International Union Against Tuberculosis and Lung Diseases (Chair, HIV Section 2009-11); Member, International Scientific Advisory Expert Group for the All-Party Parliamentary Group on Global Tuberculosis (APPG TB), UK; and Member, Third World Organization of Women Scientists. She also serves as a Member, UNAIDS Expert Panel and Member, Scientific and Technical Advisory Group, WHO Stop TB department. In addition, she serves on many national committees of the health ministry, DBT, DST and national institutes like AIIMS and Indian Institute of Science. She has the distinction of being awarded the President's Gold Medal at the undergraduate level for the best all round outgoing student of the year 1980. She was awarded ICMR Kshanika oration award by ICMR in 2008, Tamil Nadu Science and technology award in 2012 and is a Fellow of three of India's science academies. Through DHR and the network of ICMR institutes, Dr Swaminathan looks forward to focusing on key health priorities and generating scientific evidence for achieving public health impact. Further, she will work towards expanding the scope and quality of biomedical research being conducted in our medical colleges. ]]> <![CDATA[India to soon have national academy for drug regulators]]> https://biospectrumindia.com/news/95/7589/india-to-soon-have-national-academy-for-drug-regulators.html https://biospectrumindia.com/news/95/7589/india-to-soon-have-national-academy-for-drug-regulators.html Mon, 07 Sep 2015 14:24:00 +0530 The proposed academy geared to train regulators both at the Central level as well as in states is expected to be operational from the year, 2016. It will also be extending such facilities for regulators from neighbouring and CIS countries. The academy would become fully functional by 2018 and would have excellent facilities for training and research. This was recently revealed by Mr KL Sharma, joint secretary (regulations), ministry of health and family welfare at CII's 8th Medical Technology Conference held in New Delhi recently. Mr Sharma exhorted industry to take advantage of the academy by suggesting modules to be included in the course. There would be courses of various durations at the academy, which, he hoped, would create enough manpower for handling the challenging the issues faced by the drug industry in general and medical device sector in particular. Responding to a query from the floor for having standards and common practices in the industry to evince the interest of the investors, Mr Sharma opined that the proposed academy would take care of many of the perceived challenges of the industry. The government would seek inputs from the industry and hold regular consultations for making the working of the academy to meet the expectations of the stakeholders. Referring to the large scale e-governance program being launched by the government, Mr Sharma said that the government has outsourced the work of creating e-governance structure to C-DAC and some work is being carried out by NIC. In two-year's time, it would be possible to send replies to stakeholders about their queries through SMS and e-mails. Responding to another query from the floor about the on line sale of medical devices, Mr Sharma said that he could not comment on the issue since it required some more consultations and clarity in policy. About the need of a single window clearance of applications for license and other procedures, he maintained that the government was working on that by taking views of the stakeholders. Mr Sharma also mentioned that the Cabinet has approved Rs 2000 crore for setting up new laboratories and for doubling the strength of the regulators across the country. On clinical trials, he said that the government would soon put in public domain a manual for seeking the views of the stakeholders. The meeting was also addressed by Dr GN Singh, Drug Controller General of India, Central Drugs Standards Organization, who wanted industry to give regular feedback on the organization's working. ]]> <![CDATA[Wockhardt increases investment in R&D]]> https://biospectrumindia.com/news/95/6265/wockhardt-increases-investment-in-rd.html https://biospectrumindia.com/news/95/6265/wockhardt-increases-investment-in-rd.html Mon, 07 Sep 2015 12:38:00 +0530 Addressing shareholders in the company's annual report, Indian drugmaker Wockhardt said that the company plans to further strengthen its research and development capabilities and will continue to develop innovative medicines. The company's managing director, Mr Murtaza Khorakiwala, said the firm has set up three world-class, multi-disciplinary R&D facilities in India, the UK and the US, which are engaged in studies and experiments to develop new drugs and novel drug delivery systems for tomorrow. "The R&D efforts comprise of over 850 scientists, research associates and technicians focusing on generics and new drug discovery program concentrating on anti-infectives and recombinant bio-pharmaceuticals," said Mr Khorakiwala. "To meet unmet medical needs across the world, we will continue to focus on building our domestic business, sustaining business in developed markets and exploring new markets globally," he added. Wockhardt's new drug discovery programme has been recognized with QIDP (Qualified Infections Disease Product) status by USFDA for three new breakthrough drugs under development, making it the first pharma company in the world to hold this distinction. ]]> <![CDATA[Brazil approves Caplin Point's sterile injectable site]]> https://biospectrumindia.com/news/95/7485/brazil-approves-caplin-points-sterile-injectable-site.html https://biospectrumindia.com/news/95/7485/brazil-approves-caplin-points-sterile-injectable-site.html Mon, 07 Sep 2015 12:08:26 +0530 Caplin Point has received approval from Brazil's National Health Surveillance Agency ANVISA (AgÃªncia Nacional de VigilÃ¢ncia SanitÃ¡ria) for its sterile injectable manufacturing site at Chennai. With this approval the company gains access to register and market its products in the Brazilian pharmaceutical market. Caplin's facility was also recently approved by EU-GMP in July 2015. Caplin manufactures liquid injectables in vials, ampoules, lyophilized vials and ophthalmic dosages at this site. Caplin Point Laboratories Limited is a niche pharmaceutical company with a unique business model catering predominantly to emerging markets of Latin America and Africa. Caplin Point caters to a complete range of finished dosage forms. The company currently holds over 1600 product licenses across Latin America and Africa with another 400 in the pipeline. It is believed that the company will also be filing its first ANDAs by early 2016. ]]> <![CDATA[Dr Reddy's introduces new Hair Therapy]]> https://biospectrumindia.com/news/95/7215/dr-reddys-introduces-new-hair-therapy.html https://biospectrumindia.com/news/95/7215/dr-reddys-introduces-new-hair-therapy.html Mon, 07 Sep 2015 11:40:28 +0530 Dr Reddy's Laboratories has announced its entry into the Hair Serum Market with the launch of MINTOP PRO - Procapil Hair Therapy. MINTOP PRO comes from the same branch of business that manufactures MINTOP - the No. 1 dermatologist recommended brand in the country. PROCAPIL consists of a patented vitaminated matrikine with Apigenin and Oleanolic acid, which specifically targets the three main reasons responsible for hair loss. Naturally derived Oleanolic acid inhibits the production of Dihydrotestosterone, a chemical derivative of testosterone, which plays a major role in hair loss in most men and some women. Apigenin enhances microcirculation into the hair follicles keeping it nourished, while Biotinyl-GHK helps normalize hair anchorage in the lower layer of skin thereby demonstrating anti - ageing properties. Clinical studies reveal that, MINTOP PRO demonstrated promising results with a 121 percent increase in hair shaft growth as compared to placebo and 67 percent volunteers witnessed a noteworthy rise in Anagen to Telogen Ratio of upto 46 percent . (A/T ratio or hair growth coefficient is the ratio of the number of anagen hairs to the number of telogen hairs, indicates the proportion of active hair follicles). MINTOP PROTM will be available in a 75 ml pack with MRP of Rs 995/- at all leading pharmacy stores across India. ]]> <![CDATA[Cipla acquires two US-based generic Cos for $550 mn]]> https://biospectrumindia.com/features/95/7147/cipla-acquires-two-us-based-generic-cos-for-550-mn.html https://biospectrumindia.com/features/95/7147/cipla-acquires-two-us-based-generic-cos-for-550-mn.html Fri, 04 Sep 2015 16:32:48 +0530 The deal is said to be an all cash transaction worth $550 million. The combined revenue from these transactions is over $200 million for the year ended Dec 2014 and over $225 million in LTM June 2015. Located in New York (NY), InvaGen was established in 2003, and focuses on development, manufacturing, marketing and distributing of generics on a wide range of therapeutic areas including cardiovascular, anti-infective, CNS, anti-inflammatory, anti-diabetic and anti-depressants. Through this acquisition, Cipla will also gain InvaGen's 3 manufacturing units located in Long Island, NY. The units boast of production capacity of 12 billion tablets and capsules per year. InvaGen currently employees 500 professionals. Cipla's Mr Subhanu Saxena, MD & global CEO, said that the acquisitions are in line with the company's strategy to grow its share in the US pharmaceutical market. In July 2015, Mumbai-based Lupin Pharma acquired eight-year-old US-based privately held Gavis Pharmaceuticals for $880 million. Lupin's CEO Ms Vinita Gupta voiced that the company was looking to expand and deepen its US presence. InvaGen is the US arm of Hyderabad-based drug manufacturer Hetero Drugs. Camber Pharmaceuticals is also a US subsidiary firm of Hetero. In an official statement, Hetero clarified that the current sale of InvaGen is the sale of strategic investment by the Hetero promoter group which has a different product portfolio than Hetero. "InvaGen Pharmaceuticals is not linked directly to the flagship companies of the Hetero group, that is, Hetero Drugs or Hetero Labs," Hetero's spokesman said. Hetero also commented that it will continue to strengthen its presence in US market by investing in US generics and specialty products through Camber Pharmaceuticals. InvaGen is managed by executives of Indian origin, namely, Dr Sudhakar Vidiyala, the president & CEO, and Mr Madhava U Reddy, as the COO. The acquisition of InvaGen also provides Cipla with about 40 approved ANDAs, 32 marketed products, and 30 pipeline products which are expected to be approved over the next 4 years, said Cipla in a media statement. Cipla considers this acquisition to be the second landmark acquisition in its 80 years of existence. The company will also have the advantage of gaining access to large wholesalers and retailers in the US. InvaGen has filed 5 first-to-file products which represent a market size of approximately US $8 billion in revenue by 2018. The acquisition of Exelan Pharmaceuticals provides Cipla access to the government and institutional market in the US. Exelan Pharmaceuticals is a four-year-old privately held, sales and marketing company, with a focus on generic pharmaceuticals for the government and institutional market. Exelan started selling products in 2012, including those manufactured by Pfizer, AstraZeneca, Merck, UCB, Sanofi Aventis, Bristol Myers Squibb, Teva, and Novartis. Barclays is acting as Cipla's financial advisor. Hughes Hubbard & Reed are acting as legal advisor. Jefferies is acting as financial advisor to InvaGen, and Manatt, Phelps & Phillips are acting as legal advisor. In August, Cipla lost on its bid worth $1.3 billion for buying Kremers Urban Pharmaceuticals, the US unit of Belgian drugmaker UCB, which was later purchased by US-based generic manufacturer Lannett for $1.23 billion. A few days ago, Cipla also purchased skincare product marketing rights from India's Percos for Rs 90 crore. In May, there were media reports stating that vaccine behemoth Serum might acquire Cipla. In the last couple of years, Cipla has been actively engaged in tapping the world's emerging markets. Earlier in September 2014, Cipla announced its plans to invest in Kenya, Czech and Slovakian markets. It signed another agreement to buy 51 percent stake in a pharmaceuticals manufacturing and distribution business in Yemen. It also acquired Sri Lankan drug distributor for $14 million. In 2014, it invested Rs 225 crore for erecting its manufacturing facility in Iran. In 2013, Cipla acquired its distribution partner, Cipla Medpro South Africa, for $512 million. ]]> <![CDATA[Five IITs set to host DBT's Center for Bioenergy]]> https://biospectrumindia.com/news/95/5543/five-iits-set-to-host-dbts-center-for-bioenergy.html https://biospectrumindia.com/news/95/5543/five-iits-set-to-host-dbts-center-for-bioenergy.html Fri, 04 Sep 2015 15:02:34 +0530 The first virtual Centre for collaborative research will focus on the thematic areas of research in advance bio-fuel technologies. The collaboration initiated in January, 2015 and engaged a research team from the five participating Indian Institute of Technology (IITs) consisting of 32 investigators who have been working on bio-energy and will jointly undertake research activities in the various thematic areas. The "DBT-Pan IIT Centre for Bioenergy" will do advanced research on advance bio-fuel technologies like cyanobacterial bio-fuels, bio-fuels from micro-algae, ligno-cellulosic biomass to bio-fuels and also on techno-economic and life cycle analysis.The virtual centre spread across 5 Indian Institutes of Technology; Bombay, Kharagpur, Guwahati, Jodhpur, and Roorkee and coordinated by IIT Bombay was formally launched by signing a Memorandum of Agreement (MoA) at New Delhi on September 3, 2015. Memorandum of Agreement was signed between DBT and the participating 5 IITs in presence of Prof K VijayRaghavan, secretary DBT. The meeting was attended by Dr RenuSwarup (senior advisor, DBT), Prof Devang Khakhar (director, IIT Bombay), Prof Pradipta Banerji (director, IIT Roorkee), Prof Gautam Biswas, director, IIT Guwahati), Dr Sangita Kasture (joint director, DBT), Prof Pramod Wangikar (coordinator of the centre, IIT Bombay), Prof V Narayanan (IIT Jodhpur) and Prof Saikat Chakraborty (IIT Kharagpur). The main objective of this centre is to develop advanced technologies in the area of biofuels, paving the way for a sustainable solution to the energy crisis.Though the first virtual centre, it is the fourth centre in Bio-energy research set up by DBT in addition to the DBT-IOC Centre for Advanced Bioenergy Faridabad, DBT-ICT Centre for Energy Biosciences, Mumbai and DBT-ICGEB Centre for Advanced Bioenergy, New Delhi. This is also the largest among the four Bioenergy Centers in terms of investigator participation. The Centre also aims to develop a mutually beneficial relationship with the bio-energy industry in India. ]]> <![CDATA[Experts bet big on PPP, technology at CII Healthcare Conclave]]> https://biospectrumindia.com/news/95/8218/experts-bet-big-on-ppp-technology-at-cii-healthcare-conclave.html https://biospectrumindia.com/news/95/8218/experts-bet-big-on-ppp-technology-at-cii-healthcare-conclave.html Fri, 04 Sep 2015 14:37:00 +0530 Experts from healthcare industry called for active industry participation under PPP mode, and focus on technological advancements as the only solution to vast prevailing disparity in healthcare at the CII Conclave on NextGen Healthcare - Roadmap: Quality Healthcare for All, organized by CII at New Delhi, on September 03, 2015. They also stressed upon the need for active collaboration and support of various stakeholders like the industry, cooperatives and the NGOs in strengthening healthcare delivery systems, drugs distribution, use of Information Technology (IT), latest technologies and enhanced pharma supply chain management. "Integration of working of five key ministries i.e the Ministry for Rural Development, Women and Child welfare, Water, Urban sanitation, Education and health is quite imperative", said Mr Dr Dinesh Batra, Co-Chairman, CII Healthcare & Director, Cygnus Hospitals. "If these five ministries can derive coordinated campaigns and launch joint schemes, then they would be far better equipped to provide quality healthcare to each and every individual of this country", he added. "This is because some of the challenges lie outside health-care policy. Two-thirds of the health problems can also be solved by providing safe drinking water and sanitation. Even if we concentrate on these basic facilities, we can control many waterborne and airborne infectious diseases", he informed. "Each year 39 million people in India enter BPL category due to poor delivery of healthcare services. To confront this, industry has to by-pass the rules and regulations and bureaucratic bottlenecks and find out innovative ways or build confidence with Chief Ministers and get MC regulations eased, to build world class hospitals and strengthen healthcare delivery system in India. For this, the key is good intent and strong political will of the government", emphasized Mr Batra. "Though the share of Healthcare sector has increased from 0.9 percent to 2.5 percent of GDP in the 12th Five Year Plan, but still it is far low as compared to other countries, considering the diverse challenges of our vast country. For example, US spends 20 % of its GDP on healthcare. Hence we need support of all stakeholders like the Industry, NGOs, cooperatives etc. Industry presently spends 70 percent of the total spend on healthcare while government spends 30 percent. What we also need is the maximum utilization of the funds", shared Mr Dr Dharmendra Nagar, managing director, Paras Healthcare. "It is very disheartening that still, 45 % of the Indian children are malnourished, our mothers are anemic, our villages have poor hygiene, while around 400 million abject poor are deprived of any healthcare services in India. Hence, we need to gear up our healthcare delivery mechanisms and for this, partnership is the only solution. There is a 160 billion USD untapped potential by 2017 in healthcare including hospitals, pharmaceuticals and delivery systems etc in India, which industry can really benefit from. With latest technologies, we can reach out to even the last man in remotest area in the present day Digital India, since 900 million people in India are accessible through mobile phones while another 120 million through internet. CII would consider creating a group on this state subject and take it further at state level", Dr Dinesh Dua, Vice Chairman, CII Chandigarh Council and CEO and director, Nectar Lifesciences. "Some key issues that need to be addressed include like lack of infrastructure and manpower, inaccessibility of healthcare services, shortage of medical specialists and inefficiency of public healthcare providers. Though, in major urban areas, healthcare is of adequate quality and accessible, but its access is limited or unavailable in most rural areas and Tier II & Tier III cities, for which technology and partnership is the answer", shared Mr Amit Mookim, country principal, South Asia, IMS Health. ]]> <![CDATA[ASSOCHAM petitions health ministry, seeks predictable regulatory structure for clinical trials]]> https://biospectrumindia.com/news/95/7233/assocham-petitions-health-ministry-seeks-predictable-regulatory-structure-for-clinical-trials.html https://biospectrumindia.com/news/95/7233/assocham-petitions-health-ministry-seeks-predictable-regulatory-structure-for-clinical-trials.html Fri, 04 Sep 2015 14:05:44 +0530 In a note submitted to the health ministry, the key industry body, ASSOCHAM has pointed towards the fact that despite having 16 percent of the world's population and 20 percent of the disease burden, currently only 1.5 percent (approx) of global clinical trials are being conducted in India. The chamber mentioned that while industry is committed to complying with the new regulations notified in 2013 to ensure the interest of patients like: Rule 122 DAB of the Drugs & Cosmetics Amendment Rules, 1945 (DCR) on Compensation in case of injury or death of a clinical trial subject during clinical trials. However, certain outstanding concerns remain particularly in respect of criteria entitling a patient to compensation, broad definition of 'trial related injury' and the strict and unreasonable reporting timelines required to be followed in case of serious adverse events. "The issues pertaining to Issues pertaining to definition of clinical trial related injury, compensation to be paid in case of clinical trials related injuries or deaths, establishment of the appellate authority in case of disputes on causality and compensation issues, bio-equivalence and bio-availability studies, timelines for approval process etc. need to be streamlined at the earliest along the lines of international best practices in order to establish a regulatory mechanism which is predictable, stable and transparent," said the note. ASSOCHAM also suggested that Central Drug Standard Control Organisation (CDSCO) should be strengthened and up-gradated with skilled and experienced personnel so that clinical research applications are reviewed expeditiously. Other suggestions included the ones on right communication about importance of clinical trials. The note mentioned: "There is an urgent need to allay the myths around clinical trials - clinical trials are not unsafe and are not conducted in India only because of cost effectiveness, patient vulnerability and lack of regulatory safeguards. Patients/subjects across the globe take an informed decision to participate in clinical research after made fully aware of the potential benefits and risks involved and clinical research is carried out in a highly regulated environment. Such myths can be allayed by creating awareness at all levels - judiciary, law making authorities, Members of Parliament and the media." The note by ASSOCHAM concluded by mentioning that health ministry needs to create awareness about the importance of clinical research to be conducted in India along the lines of recommendations of the Department Related Parliamentary Standing Committee on Health and Family Welfare in its 59th Report, i.e., testing drugs in the Indian ethnic groups is of paramount importance before approving any drug of foreign origin. ]]> <![CDATA[Glenmark gets FDA nod for Voriconazole Tablets]]> https://biospectrumindia.com/news/95/5678/glenmark-gets-fda-nod-for-voriconazole-tablets.html https://biospectrumindia.com/news/95/5678/glenmark-gets-fda-nod-for-voriconazole-tablets.html Fri, 04 Sep 2015 12:06:33 +0530 Glenmark Pharmaceuticals (Glenmark) has been granted final approval by the United States Food and Drug Administration (US FDA) for Voriconazole Tablets, 50 mg and 200mg, the therapeutic equivalent of Vfend Tablets, 50 mg and 200 mg of PF Prism C.V. (Prism). According to IMS Health sales data for the 12 month period ending July 2015, the Vfend market1 achieved annual sales of approximately $91.4 million. Voriconazole is used in certain types of fungal infections. ]]> <![CDATA[New batch enrolment kick-starts at Biocon Academy ]]> https://biospectrumindia.com/news/95/4241/new-batch-enrolment-kick-starts-at-biocon-academy-.html https://biospectrumindia.com/news/95/4241/new-batch-enrolment-kick-starts-at-biocon-academy-.html Thu, 03 Sep 2015 17:04:48 +0530 The admission process for Batch 6 will be on till October 31, 2015 and classes will commence on January 11, 2016. The Academy's 'Biocon-KGI Certificate Program in Biosciences' is a 16-week, full-time certificate program that offers a broad-based international curriculum encompassing Industrial processes, Production, Quality Assurance, Regulatory Affairs and Product Development. Biocon Academy leverages the technical expertise and industrial leadership of Biocon along with the strong academic excellence of its international education partner Keck Graduate Institute (KGI) in California, US, to make biotech students industry-ready. Both freshers and biotechnologists with some initial experience can enroll for this program to sharpen their skills and advance their learning, which will enhance their career prospects. Online applications will be screened by academic experts and shortlisted candidates will have to successfully clear the interview stage to be selected for the course. Biocon offers a scholarship that covers up to 75% of the course fee for selected candidates. Mr S S Easwaran, academic director, Biocon Academy, said, "The Biosciences program is a bridge from academia to the biotechnology industry for biosciences students as it enhances education outcomes through experiential learning methods. Till date, 120 young biotech professionals have benefited from the intensive 16-week course and have readily found employment with reputed global biotech/ pharma companies. The feedback from employers is also extremely positive." Dr Meghana Joshi, program director, Keck Graduate Institute (KGI), said, "The Biocon-KGI program is an extension of the programs conducted by KGI in the US and offers a good opportunity for biosciences students in India to develop a deeper understanding of the biotech industry and the overall business of science. Early in their career, students benefit both from the varied background and experiences of the faculty as well as the mentorship of subject matter experts from Biocon." ]]> <![CDATA[Cipla buys skincare product marketing rights worth Rs 90 cr]]> https://biospectrumindia.com/news/95/7232/cipla-buys-skincare-product-marketing-rights-worth-rs-90-cr.html https://biospectrumindia.com/news/95/7232/cipla-buys-skincare-product-marketing-rights-worth-rs-90-cr.html Thu, 03 Sep 2015 15:39:20 +0530 The company's skincare products focuses on treating disorders including acne, skin ageing, psoriasis, eczema and dark circles among others. According to a report by The Economic Times, Percos for the next five years will continue to manufacture the products, and later transfer the rights to Cipla. The 18-year-old Percos' has its manufacturing facility in Haridwar, Uttarakhand. Percos also claims that it has partnered with DRDO (Defence Research and Development Organization) for the development and manufacturing of high altitude sun screen to aid armed forces and civilians who are engaged in work in hostile environments. Last month, Cipla was the only key bidder for Kremers Urban, the specialty generics drug business of the US $4 billion Belgian drug maker UCB, and the deal was pegged at US $1.3 billion. On September 3, 2015, Cipla at 1400hrs was trading at Rs 659.65, up by 9.60 or 1.48% on the Bombay Stock Exchange (BSE). Cipla's Q1 FY 2015-16 revenues stood at Rs 3,853 crore compared to Rs 2,720 for the same quarter in the previous fiscal 2014-15. ]]> <![CDATA[Fermenta Biotech joins forces with Vitamin Angels ]]> https://biospectrumindia.com/news/95/6339/fermenta-biotech-joins-forces-with-vitamin-angels-.html https://biospectrumindia.com/news/95/6339/fermenta-biotech-joins-forces-with-vitamin-angels-.html Thu, 03 Sep 2015 12:55:10 +0530 Fermenta Biotech, a driving force in propagating vitamin D awareness in India, has joined hands with Vitamin Angels. Through their partnership, they are determined to solve the fundamental problem of undernutrition-a widespread challenge, especially in rural areas. Undernutrition, also known as "hidden hunger", occurs when individuals consume enough calories to survive, but the foods they eat lack adequate nutritional value. Poverty, food insecurity, lack of opportunity, limited resources, and even political instability can impact a child's or mother's nutritional status. Children under five, pregnant women, and new mothers are the most vulnerable to undernutrition. Vitamins Angels is working to combat undernutrition through a comprehensive approach that starts with vitamin supplementation and includes support for breastfeeding women, deworming, and more. "It is a privilege for Fermenta Biotech to be able to support the global endeavors of the nonprofit organization, Vitamin Angels," says Mr Prashant Nagre, chief executive officer of Fermenta Biotech. He added, "It feels great to join Vitamin Angels' compassionate initiative and be able to make a difference towards health and wellbeing of thousands of people the world over. Our motto is to discover, develop and deliver futuristic health solutions that help embrace a well-nourished life. Vitamin Angels is a perfect partner in that endeavor. "We are so pleased to partner with Fermenta Biotech," said Mr Howard Schiffer, president and founder of Vitamin Angels. He added, "Their support is essential to the work that Vitamin Angels is doing in India and around the world. We are grateful for their support and look forward to a long partnership." ]]> <![CDATA[New high purity grade solvents for UHPLC-MS instruments]]> https://biospectrumindia.com/news/95/5664/new-high-purity-grade-solvents-for-uhplc-ms-instruments.html https://biospectrumindia.com/news/95/5664/new-high-purity-grade-solvents-for-uhplc-ms-instruments.html Thu, 03 Sep 2015 10:45:21 +0530 New, pure mobile phase solvents for ultra-high-performance liquid chromatography-mass spectrometry (UHPLC-MS) instruments have been designed to reduce background signal and minimize chromatographic interferences, facilitating accurate, sensitive and rapid trace analysis. Fisher Chemical Optima UHPLC-MS solvents are high-quality, ultra-pure and designed to address the trace analysis needs ofchromatographers performing state-of-the-art UHPLC. These new solvents are qualified for use with UHPLC/MSinstrumentation, such as the Thermo Scientific Vanquish system. UHPLC-MS is becoming the preferred technique to LC-MS in analytical laboratories, as it enables users to perform separations substantially faster, due to the innovative sub-2 micron columns. Submicron filtration also reduces the clogging of instruments, columns and check valves. A typical LC-MS gradient run can take up to 60 minutes, whereas UHPLC-MS can reduce this to just five minutes, while yielding a similar resolution without compromising flow rates. Optima UHPLC-MS solvents are ideal for detecting trace amounts of analyte by MS/MS using either gradient or direct-flowanalysis without baseline interference. Notably, Optima UHPLC-MS solvents provide a very low mass/noise level in both positive- and negative-mode ionization, minimal metal ion content and a low UHPLC-UV response using photo diode array detection. "The quality of these high-purity solvents is linked directly to the sensitivity of high-end mass spectrometers, where parts-per-trillion levels of analyte can be detected by the signature product ion peaks, " said Subhra Bhattacharya, senior product development scientist at Thermo Fisher Scientific. "The low signal-to-noise ratio achieved with the Optima UHPLC-MS solvents highlights the ultrahigh purity, resulting in minimal background interference" , he added. ]]> <![CDATA[Cipla appoints two new management members ]]> https://biospectrumindia.com/news/95/4197/cipla-appoints-two-new-management-members-.html https://biospectrumindia.com/news/95/4197/cipla-appoints-two-new-management-members-.html Wed, 02 Sep 2015 15:42:12 +0530 Until recently Mr Umang was the head of the North America business for Dr Reddy's. He was instrumental in growing this business by over 60% to cross a US $1 billion sales, almost half the revenues of Dr Reddy's, through several business development partnerships, acquisitions as well as growing the oncology health system business. Prior to this, Mr Umang was the global CFO of Dr Reddy's for four years and was widely credited with the significant improvement in the company's ROCE (return on capital employed). Prior to Dr Reddy's, he worked with PepsiCo and Eicher Motors. In addition to the finance role, Mr Umang will be responsible for strategy, portfolio, business development, mergers and acquisitions and business technology. Commenting on his appointment, Mr Subhanu Saxena, MD and global CEO, Cipla, said "We are delighted that Mr Umang Vohra is joining the leadership team at Cipla. He brings deep insights about the global generics industry as well as an understanding of value creation through his background in leading business and finance roles." Mr Prabir will be providing leadership to the HR function globally for the company, and he will also lead the corporate communications and administration functions. He is an alumnus of St Stephen's College and XLRI Jamshedpur. After a decade long tenure as a civil servant, he has pursued a corporate career in human resources. As the chief HR officer at some of the country's leading corporations like Dr Reddy's, Tata Motors and most recently, Reliance Industries, Prabir has built a solid reputation as an organisation transformation strategist and a very progressive HR practitioner. Commenting on his appointment, Ms Samina Vaziralli, executive director who has been interim head of HR said, "We are in a very exciting stage of growth for Cipla. We truly believe focusing and building on human capital is one of the ultimate sources of sustainable, competitive advantage. Having Prabir on our executive leadership team, to help us steer this agenda will ensure that our commitment to cutting edge people practices is at the heart of everything we do at Cipla." ]]> <![CDATA[Ministers from South-East Asia meet in Dili to set health priorities ]]> https://biospectrumindia.com/news/95/4148/ministers-from-south-east-asia-meet-in-dili-to-set-health-priorities-.html https://biospectrumindia.com/news/95/4148/ministers-from-south-east-asia-meet-in-dili-to-set-health-priorities-.html Wed, 02 Sep 2015 15:08:13 +0530 Health Ministers of the 11 countries of WHO's South-East Asia Region are meeting in Dili, Timor-Leste, from 7-11 September to set health priorities and discuss the health agenda for the region. Coming close on the heels of the earthquakes in Nepal and the spread of MERS Coronavirus, strengthening response to emergencies and outbreaks and building capacities under the International Health Regulation (IHR) 2005 will be one of the key areas for discussion at the Sixty-eighth Session of the Regional Committee Meeting of WHO South-East Asia. The Prime Minister of Timor-Leste, Dr Rui Maria de AraÃºjo, will inaugurate the meeting. WHO South-East Asia Regional Director, Dr Poonam Khetrapal Singh, WHO experts and senior officials from health ministries of member countries will be present. Among the topics on the agenda will be: accelerating efforts to protect people against tobacco, advocating for health in the post-2015 Global Sustainable Development Goals, and expanding effective services with stronger health workforce. The Regional Committee, the highest policy making body of WHO in the Region, will also deliberate on anti-microbial resistance, an issue which needs urgent attention and action. Eliminating neglected tropical diseases like kala-azar, leprosy, yaws, filariasis and schistosomiasis; adapting and implementing the End TB strategy; the way forward for preventing and controlling cancer; and sustainable universal health coverage will be other areas of focus at the meeting. The status of measles elimination and control of rubella in the Region by 2020, polio eradication initiatives, effective management of medicines and health information systems, will also be discussed in the meeting. The Regional Committee meets annually and is hosted by one of the 11 member countries of South-East Asia. This is the first time that the Regional Committee is meeting in Timor-Leste. WHO's South-East Asia Region comprises the following 11 Member States: Bangladesh, Bhutan, Democratic People's Republic of Korea, India, Indonesia, Maldives, Myanmar, Nepal, Sri Lanka, Thailand and Timor-Leste. ]]> <![CDATA[Dr. Srinivasa Reddy bags NASI-Reliance Industries Platinum Jubilee Award ]]> https://biospectrumindia.com/news/95/4217/dr-srinivasa-reddy-bags-nasi-reliance-industries-platinum-jubilee-award-.html https://biospectrumindia.com/news/95/4217/dr-srinivasa-reddy-bags-nasi-reliance-industries-platinum-jubilee-award-.html Wed, 02 Sep 2015 12:17:00 +0530 Dr. D. Srinivasa Reddy, a senior scientist from CSIR- National Chemical Laboratory (CSIR-NCL), Pune has been chosen to receive this year's NASI- Reliance Industries Platinum Jubilee Award for the Application Oriented Innovations in the area of physical sciences. Award carries a plaque and Rs. 2 lakhs in cash will be presented in the 85th annual session of National Academy of Sciences, India. Dr. Reddy's research group interests are in the field of total synthesis and drug discovery by applying medicinal chemistry. He has also been involved in the synthesis of the agrochemicals like small molecules for crop protection. The total synthesis of more than twenty natural products has been achieved in his lab including a sex pheromone that attracts the mealy bugs and has potential use in the crop protection. On the medicinal chemistry front significant progress has been made by his group using a new concept called "Silicon-switch approach" towards central nervous system drugs. Identification of New Chemical Entities for the potential treatment of diabetes and infectious diseases is being done in collaboration with industry partners. Dr. Reddy had worked with pharmaceutical companies for seven long years before joining CSIR-NCL in 2010. His efforts are evidenced by more than 60 publications and 30 patents. He has recently received the CRSI bronze medal; in addition he is also the recipient of Central Drug Research Institute award for excellence in the drug research in chemical sciences and scientist of the year award by the NCL Research Foundation in the year 2013. ]]> <![CDATA[Sun Pharma completies acquisition of Opiates business in Australia]]> https://biospectrumindia.com/news/95/4005/sun-pharma-completies-acquisition-of-opiates-business-in-australia.html https://biospectrumindia.com/news/95/4005/sun-pharma-completies-acquisition-of-opiates-business-in-australia.html Wed, 02 Sep 2015 10:40:04 +0530 Sun Pharmaceutical begins the integration of its Opiates business in Australia following the successful completion of this acquisition from GSK (announced in March 2015). This acquisition fortifies Sun Pharma's global position with two Opiates manufacturing facilities in Port Fairy & Latrobe (both in Australia)complementing its current API manufacturing footprint globally. Sun Pharma now offers a rich basket of Opiates product line in addition to a large API portfolio and dosage formulations covering a broad range of chronic and acute prescription drugs. The acquisition also brings a specialized team to drive business growth. Welcoming the Opiates team in Australia, Mr Anil Kumar Jain, CEO - API Business, Sun Pharma said, "The successful completion of this acquisition enables us to leverage our unique position in the global Opiates business by capitalizing our global footprint and global ranking in the specialty generics market. Sun Pharma stays committed to uncompromsed product quality, 100 percent compliance and innovation." Over the last few months, the Opiates & Sun Pharma teams put together a transition plan to oversee the implementation of the functional integration of Opiates business. The transition process will emphasize on aligning best functional requirements and leveraging employee talents in this business. ]]> <![CDATA[Sanofi to collaborate with Google Life Sciences to improve diabetes health outcomes ]]> https://biospectrumindia.com/news/95/3874/sanofi-to-collaborate-with-google-life-sciences-to-improve-diabetes-health-outcomes-.html https://biospectrumindia.com/news/95/3874/sanofi-to-collaborate-with-google-life-sciences-to-improve-diabetes-health-outcomes-.html Tue, 01 Sep 2015 17:10:17 +0530 Sanofi and the life sciences team at Google announced that they are collaborating to improve care and outcomes for people with type 1 and type 2 diabetes. The collaboration will pair Sanofi's leadership in diabetes treatments and devices with Google's expertise in analytics, miniaturized electronics and low power chip design. The companies will explore how to improve diabetes care by developing new tools that bring together many of the previously siloed pieces of diabetes management and enable new kinds of interventions. This includes health indicators such as blood glucose and hemoglobin A1c levels, patient-reported information, medication regimens and sensor devices. Both parties will combine their respective expertise in science and technology to work on better ways to collect, analyze and understand multiple sources of information impacting diabetes. The hope is that it will be easier for patients to successfully manage their diabetes, which would reduce the risk of complications, improve outcomes and ultimately lower costs. "As a global leader in diabetes care, we have both an obligation and a commitment to provide integrated solutions for people living with diabetes," said Dr Olivier Brandicourt, CEO, Sanofi. "This initiative combines Sanofi's strength and knowledge in diabetes with Google's leadership in technology and analytics to create a first-of-its-kind initiative with the potential to transform diabetes care." "We are experiencing a worldwide pandemic of diabetes, and it's very encouraging to see healthcare and technology innovators step up to the challenge of providing cutting edge tools and care advancing technologies to help people with diabetes manage their disease, 24/7," said Mr John L. Brooks, III, president and CEO, Joslin Diabetes Center, which is a partner to the collaboration. "Technology, sensors, analytics, and digital solutions will revolutionize how blood sugars are managed, which will deliver improved quality of life, lowering the risk of complications and reducing the costs and barriers associated with diabetes care. Ultimately, I truly hope we're able to turn the Joslin Diabetes Center into a museum." ]]> <![CDATA[Strides completes acquisition of Aspen in Australia]]> https://biospectrumindia.com/news/95/7320/strides-completes-acquisition-of-aspen-in-australia.html https://biospectrumindia.com/news/95/7320/strides-completes-acquisition-of-aspen-in-australia.html Tue, 01 Sep 2015 11:22:20 +0530 Bangalore-based Strides Arcolab has announced that it has completed acquisition of Aspen Pharmacare's generic pharmaceutical business and related assets in Australia. The transaction is worth A$380 million(approx. $297 million). "The transaction has now achieved closure on completion of closing conditions and statutory and regulatory approvals," Strides said in a statement. "The acquired business will be integrated and consolidated with Strides effective September 1, 2015," the company added. The business will operate under the Arrow Pharmaceuticals brand. ]]> <![CDATA[Formal sale of Indian unit to begin soon: Adcock]]> https://biospectrumindia.com/news/95/4214/formal-sale-of-indian-unit-to-begin-soon-adcock.html https://biospectrumindia.com/news/95/4214/formal-sale-of-indian-unit-to-begin-soon-adcock.html Mon, 31 Aug 2015 17:57:53 +0530 In its year-end 2015 financial report, Adcock expressed concerns over the underperformance of Cosme. "As time has evolved, management has recognized the difficulties of operating an enterprise in such a competitive pharmaceutical market (India), which, in relative terms is sub scale, requiring inter alia, and significant further investment. "In 2014 financial year, given the losses incurred, after the obligatory internal intangible asset amortization, the Cosme Pharma investment was impaired by an amount of R278 million," Adcock revealed. The trading loss of R56.8 million, incurred in the current financial year, dictated that a further impairment of R74.4 million would be appropriate, it said. The Group's Cosme Pharma was acquired in early 2013 for Rs 480 crore. "This related industry purchase was justified at the time by the perceived potential growth prospects of a pharma sales and distribution business, with quality, good margin products in a vast marketplace," Adcock said in a statement. Adcock is a major manufacturer and supplier of branded and generic medicines, over-the-counter (OTC) and critical care products, while Cosme was in the finished pharmaceutical formulations space. After much deliberation, Adcock's board has decided to dispose Cosme Pharma. "A formal sale process will soon be commenced..," Adcock held. When BioSpectrum contacted Adcock's HQ in South Africa, probing about the set selling price for Cosme, Adcock's spokeswoman said, "We announced that the board had resolved to dispose of this investment. The formal sale process has not yet commenced and so we cannot comment on it now." Adcock also said that its businesses in Zimbabwe, Kenya and Ghana remains a challenge. The company's CEO Mr Kevin Wakeford, earlier said, "While all divisions in the South African business did well and showed improved profitability, the rest of Africa and Indian businesses continue to post losses." "During the year under review, although the results suggest a positive turn of direction, these businesses still incurred losses of R13.2 million compared to R29.0 million in 2014," Adcock expressed. According to its year-end 2015 financial statement, its OTC turnover stood at R1 454 million over R1 248 million in 2014, which is 16.6% ahead of the comparable period, supported by renewed focus and more aggressive marketing. Its prescription turnover witnessed R1 813 million compared to R1 860 million in 2014, which is 2.6% behind the comparable period. The company attributed this to the reduction in the low margin ARV, and tender portfolios, and repatriation of certain products to multinational partners. ]]> <![CDATA[Indian healthcare industry's demand for workforce to double to 7.4 mn in 2022: Report]]> https://biospectrumindia.com/news/95/4238/indian-healthcare-industrys-demand-for-workforce-to-double-to-7-4-mn-in-2022-report.html https://biospectrumindia.com/news/95/4238/indian-healthcare-industrys-demand-for-workforce-to-double-to-7-4-mn-in-2022-report.html Mon, 31 Aug 2015 17:57:03 +0530 The Indian Healthcare industry is seeing a robust growth trajectory and is expected to grow vigorously at a CAGR of 16 per cent from $73.92 billion in 2011 to $280 billion in 2020, says FICCI-KPMG report titled - "Healthcare: The neglected GDP driver." The report was today released by Dr Jitendra Singh, Minister of State for Development of NE Region and Minister of State for Prime Minister Office, GoI at the two-day FICCI Annual flagship Healthcare Conference - FICCI HEAL 2015, this year on the theme - "India's Healthcare: Time for Paradigm Shift". Many other eminent dignitaries were also present during the report launch. The FICCI-KPMG report highlights how a robust healthcare system drives GDP growth in the presence of adequate investments and an encouraging environment by not only acting as a productivity and employment generator, but also as a magnet to attract foreign exchange earnings and provide opportunities for innovation and entrepreneurship. With Indian healthcare workforce expected to double to 7.4 million in 2022 from 3.6 million in 2013 and the sector's revenue expected to grow by a robust 16 percent CAGR to $280 billion in 2020 from $73.92 billion in 2011, Indian healthcare sector has already established itself to be an important contributor to nation's GDP. Another important finding of the report is that increasing investments, growing innovation and entrepreneurship are expected to enhance the size of the healthcare market, thereby increasing the contribution of the healthcare sector to India's GDP. India has received an aggregate of $377.3 billion in Foreign Direct Investment (FDI) from April 2000 to May 2015. Hospitals and diagnostics centres received FDI of $3.1 billion, or about 1.21 percent of the FDI inflow. The share of healthcare FDI has almost doubled since 2011, highlighting the growing interest of foreign players in the sector. Mr. Ashok Kakkar, Co-Chair, FICCI Health Services Committee & Managing Director, Varian Medical Systems International India Pvt. Ltd. said "For India to become a developed nation, it needs to first cross the milestone of becoming a healthy nation. The talk of demographic dividend can soon turn into demographic liability if the healthcare sector remains in the state of neglect. India carries 1/5th of the global disease burden & growing. There is an urgent need for a paradigm shift towards wellbeing that includes both emotional & physical, instead of just focusing on the physical sick care. We have a unique opportunity to adopt healthcare models that can deliver superior outcomes at much lesser costs." "The aim of this report is to highlight that investment in healthcare propels overall economic growth and is more than just social expenditure in India. Improvements in the health of citizens contributes to overall economic prosperity of the nation. Today, healthcare is one of the largest employers in India. The sector has attracted billions of dollars from private ventures, foreign investors and inflow of equity capital through numerous deals in the past year. Additionally, medical tourism is growing well and is contributing significantly to the overall growth in the sector," said Mr. Nilaya Varma, Partner and Head, Government & Healthcare, KPMG in India. Investment opportunities in the Indian healthcare sector have increased significantly and the sector is expected to be one of the most attractive investment targets for private equity (PE) and venture capital (VC) companies. India's healthcare sector has attracted about $1 billion in hospital assets from domestic and foreign financers. PE investments in hospitals and diagnostics chains nearly quadrupled over 2011-13. The sector attracted about 100 merger-and-acquisition deals, with an average deal size of $30 million, amounting to $3 billion since 2010. The increasing interest of foreign players and new financial provisions have benefited existing players, which are expanding, and given birth to a new set of entrepreneurs, which is changing the face of the Indian healthcare industry. Innovations focused on patients have begun to appear on the healthcare horizon. Medical tourism has emerged as a strong segment due to India's growing strength in healthcare delivery. People from different parts of the world travel to India to benefit from the comparative cost advantage and quality services. This market is expected to triple to $10.6 billion in 2019 from $2.8 billion in 2014-a 30 percent CAGR. India's telemedicine market has been growing significantly due to its potential to offer increased access, lower costs, better patient outcomes, greater patient engagement and improved safety. The global telemedicine industry is expected to grow to $27 billion by 2016 from $10 billion in 2010-a CAGR of 18 percent. Indian telemedicine though is in a nascent stage, growing by about 20 percent a year. It is expected to more than double to about $19 million by 2017 from $8 million in 2012. ]]> <![CDATA[India fully eliminates killer Tetanus]]> https://biospectrumindia.com/news/95/2566/india-fully-eliminates-killer-tetanus.html https://biospectrumindia.com/news/95/2566/india-fully-eliminates-killer-tetanus.html Mon, 31 Aug 2015 14:59:40 +0530 India has achieved a momentous public health feat - the elimination of maternal and neonatal tetanus. Maternal and neonatal tetanus is reduced to less than one case per 1,000 live births in all 675 districts of the country. WHO has validated this achievement adding India to the list of countries that have successfully battled this killer disease. This is a huge achievement for India which until a few decades ago reported 150,000 to 200,000 neonatal tetanus cases annually. Maternal and neonatal tetanus elimination (MNTE) demonstrates India's strong commitment and leadership that helped improve access to immunization, antenatal care services and skilled birth attendance in the most vulnerable populations - the poor, the remote and isolated communities where hygienic obstetric, postnatal practices and other health services were suboptimal or not accessible. "The government of India's innovative approach of utilizing elements of existing and new programs provided the synergistic lift off to make MNTE a reality. India's re-energized national immunization programme and the special immunization weeks and the most recent 'Mission Indradhanush', helped ensure that children and pregnant women are reached with vaccines. The 'National Rural Health Mission' promoted institutional deliveries with a focus on the poor. The 'Janani Suraksha Yojana' encouraged women to give birth in a health facility," said WHO in a media statement. India's MNTE success is also a huge tribute to the millions of health workers who often worked under challenging conditions, and undeniably the families and communities who recognized and accepted the benefits of these health services. WHO further added, "However, our efforts cannot stop here. Unlike smallpox and polio, tetanus cannot be eradicated as tetanus spores remain stubbornly present in the environment worldwide. As the risk of tetanus persists, we need to continue our efforts to ensure that MNTE is maintained - women and children are immunized and clean deliveries and proper cord care activities get a further boost." ]]> <![CDATA[FDA approval for BI/Lilly's diabetes combo pill ]]> https://biospectrumindia.com/news/95/5981/fda-approval-for-bi-lillys-diabetes-combo-pill-.html https://biospectrumindia.com/news/95/5981/fda-approval-for-bi-lillys-diabetes-combo-pill-.html Mon, 31 Aug 2015 12:06:05 +0530 The US Food and Drug Administration (US FDA) has approved Synjardy (empagliflozin and metformin hydrochloride) tablets, from Boehringer Ingelheim Pharmaceuticals, and Eli Lilly and Company, for the treatment of adults with type 2 diabetes (T2D). SYNJARDY is the third product containing empagliflozin to be approved by the FDA, following Jardiance (empagliflozin) and Glyxambi(empagliflozin/linagliptin). SYNJARDY is a combination of empagliflozin and metformin - two medicines with complementary mechanisms of action - to help control blood glucose in people with T2D. Empagliflozin, a sodium glucose co-transporter-2 (SGLT2) inhibitor, removes excess glucose through the urine by blocking glucose re-absorption in the kidney. Metformin, a commonly prescribed initial treatment for T2D, lowers glucose production by the liver and its absorption in the intestine. "SYNJARDY is now the fifth FDA-approved medicine to emerge from the BI-Lilly Diabetes alliance pipeline in the last four years," said Mr Paul Fonteyne, president and CEO, Boehringer Ingelheim Pharmaceuticals. He added, "No two people with diabetes are alike, and every experience is different. Our alliance is proud to offer a diverse portfolio of treatments that can help patients throughout their diabetes journey." SYNJARDY is indicated as an adjunct to diet and exercise to improve glycemic control in adults with T2D who are not adequately controlled on a regimen containing empagliflozin or metformin, or in patients already being treated with empagliflozin and metformin. SYNJARDY is not for the treatment of type 1 diabetes or diabetic ketoacidosis. The SYNJARDY label contains a boxed warning for the risk of lactic acidosis, a serious metabolic complication that can occur due to metformin accumulation during treatment with SYNJARDY. The FDA approval of SYNJARDY is based on results from multiple clinical trials examining the co-administration of empagliflozin and metformin, alone or in combination with sulfonylurea, in the treatment of adults with T2D. SYNJARDY was also recently approved by the European Medicines Agency in May 2015. ]]> <![CDATA[South Africa's Adcock plans to sell its Indian biz]]> https://biospectrumindia.com/news/95/7795/south-africas-adcock-plans-to-sell-its-indian-biz.html https://biospectrumindia.com/news/95/7795/south-africas-adcock-plans-to-sell-its-indian-biz.html Mon, 31 Aug 2015 12:00:52 +0530 Adcock Ingram, South Africa's second largest pharma company, has vocalized its plans to sell off its Indian business unit, Cosme Farma. A provider of branded and generic medicines, Adcock has set a starting price of Rs 4.8 billion for potential buyers. It also specializes in over-the-counter products, and has been a major supplier of hospital and critical care products. Cosme was founded in 1910 in Goa, and was acquired by Adcock in 2012 for Rs 480 crore. Cosme was involved in the manufacturing and marketing finished pharmaceutical formulations in India and abroad. It also manufactured products used in treating acne, anemia, osteoporosis, osteoarthritis, psoriasis, fungal infections, and eczema. On August 2015, Adcock released its 2015 year-end results along with its plan to formally sell its Indian unit. "While all divisions in the South African business did well and showed improved profitability, the rest of Africa and Indian businesses continue to post losses. Downsides included a further impairment of R74.4 million to the Cosme business in India. As a result, the board has resolved to dispose of this investment at the earliest opportunity and a formal sale process will soon be commenced for this purpose," commented Mr Kevin Wakeford, CEO, Adcock Ingram, in a statement. Adcock Ingram's turnover stood at R5.5 billion, up 6.5%. "Significant additional investment would be needed to compete effectively in the Indian market.... It (India) is an absolutely massive pharma market, but dominated by massive players as well, so if you are a small player in that market, it is just going to be a battle," Mr Wakeford told Reuters. The news arrives just in time after Merck, which announced last week, about shutting of its Bangalore GeNei facility. This year, Pfizer confirmed its plans to shut its Thane plant. In 2014, AstraZeneca (AZ) and Piramal shutdown their R&D units in Bangalore and Mumbai respectively. Novartis' generic drug unit, Sandoz too followed the same route in shutting its operations at Turbhe site in Maharashtra. ]]> <![CDATA[R&D Systems introduces ProDots recombinant proteins]]> https://biospectrumindia.com/news/95/6933/rd-systems-introduces-prodots-recombinant-proteins.html https://biospectrumindia.com/news/95/6933/rd-systems-introduces-prodots-recombinant-proteins.html Fri, 28 Aug 2015 12:33:34 +0530 R&D Systems has launched ProDots Recombinant Proteins. ProDots proteins are highly bioactive proteins packaged into easy to use lyophilized "dots". Designed to be stable at 40C and to dissolve instantly, ProDots proteins can be rolled into cell culture media quickly and easily to produce media with a desired working protein concentration ensuring optimal protein recovery and bioactivity. ProDots proteins are available as packs of 1, 10 or 50 individual vials containing one ball of protein in 5ug, 10ug & 250ug protein concentration. The accessible storage and high stability of ProDots proteins makes them ideal for quick and easy preparation of cell culture media. ]]> <![CDATA[FDA nod for Lupin's generic ulcer drug]]> https://biospectrumindia.com/news/95/6899/fda-nod-for-lupins-generic-ulcer-drug.html https://biospectrumindia.com/news/95/6899/fda-nod-for-lupins-generic-ulcer-drug.html Fri, 28 Aug 2015 12:27:55 +0530 Pharma Major Lupin Limited (Lupin) has announced that it has received final approval for its Omeprazole Delayed-Release capsules 40 mg from the United States Food and Drugs Administration (US FDA). The drug is a generic version of AstraZeneca Pharmaceuticals LP (AstraZeneca) Prilosec Delayed-Release capsules 40mg. Lupin's Omeprazole Delayed-Release capsules 40 mg are the AB rated generic equivalent of AstraZeneca's Prilosec Delayed-Release capsules 40mg. It is indicated for the short-term treatment of Duodenal Ulcer, Gastric Ulcer, treatment of Gastro Esophageal Reflux Disease (GERD), maintenance of healing of Erosive Esophagitis and Pathological Hypersecretory conditions. ]]> <![CDATA[Dr Reddy's announces management changes]]> https://biospectrumindia.com/news/95/6906/dr-reddys-announces-management-changes.html https://biospectrumindia.com/news/95/6906/dr-reddys-announces-management-changes.html Fri, 28 Aug 2015 10:51:08 +0530 Mr Umang Vohra, is moving out of the organization and has consequently stepped down from the position of executive vice-president and head North America Generics. Mr Alok Sonig, executive vice-president and head India Generics will now take over as executive vice-president and head North America Generics Mr MV Ramana, who is currently executive vice-president - Emerging Markets, has assumed additional charge and is now executive vice-president and head Branded Markets (India and Emerging countries). ]]> <![CDATA[Life cycle management strategies more crucial than ever for pharma success ]]> https://biospectrumindia.com/features/95/8036/life-cycle-management-strategies-more-crucial-than-ever-for-pharma-success-.html https://biospectrumindia.com/features/95/8036/life-cycle-management-strategies-more-crucial-than-ever-for-pharma-success-.html Thu, 27 Aug 2015 17:03:34 +0530 With shrinking Research and Development (R&D) pipelines and mounting costs involved in drug development, it is becoming increasingly important for pharmaceutical companies to implement suitable Life Cycle Management (LCM) strategies in order to maximize revenues and the lifespan of their portfolios, says business intelligence provider GBI Research. The company's latest CBR Pharma report states that there are three fundamental categories of LCM strategies, namely developmental, commercial, and regulatory/legal strategies, all of which play a key role in boosting the profitability of pharmaceutical products. Mr Priyatham Salimadugu, analyst, GBI Research, says, successful LCM planning commences early in the life cycle of a drug, ideally during the R&D phase, and that multiple factors, such as timing, disease characteristics and market environment, should be considered when choosing an LCM strategy. He comments: "The key to good LCM is not to manage a single product in isolation, but to think in terms of optimizing sales of the company's entire portfolio, both marketed and R&D, through planning and learning across the organization. "However, the changing industry and regulatory environment is impacting the effectiveness of LCM strategies themselves. As such, LCM strategy selection and implementation needs to be a dynamic and adaptive process, and having access to up-to-date market intelligence is a vital factor." Mr Salimadugu continues: "Developmental LCM strategies focus on increasing the number of patients eligible to receive a drug, such as by expanding its usage for different indications or targeting rare diseases. These strategies also focus on maximizing patient uptake, by offering more convenient methods of administration, improving dosing frequencies, or reducing side effects. "Commercial strategies include switching from prescribed to over-the-counter drugs, geographical expansion, and utilizing price flexibility. In this last case, timing and competitive intelligence are crucial to the success of strategic pricing, as altering the price too early or too late may mitigate any benefit," the analyst concludes. ]]> <![CDATA[Girish Sahni assumes charge as Director General â€“CSIR]]> https://biospectrumindia.com/news/95/6744/girish-sahni-assumes-charge-as-director-general-csir.html https://biospectrumindia.com/news/95/6744/girish-sahni-assumes-charge-as-director-general-csir.html Thu, 27 Aug 2015 14:59:38 +0530 Dr Girish Sahni, who had been the Director, CSIR-Institute of Microbial Technology (CSIR-IMTECH), Chandigarh, assumed charge as the next Director General of the Council of Scientific & Industrial Research (CSIR) and Secretary, Department of Scientific & Industrial Research (DSIR), Ministry of Science & Technology, with effect from August 24, 2015. Dr Sahni, having specialization in Protein Engineering, Molecular Biology, and Biotechnology, has contributed significantly in the area of protein cardiovascular drugs especially 'clot busters' and their mode of action in the human body. The team led by him is responsible for producing technology for India's first indigenous clot bluster drug, natural streptokinase (under brand name 'STPase' marketed by Cadila Pharmaceuticals Ltd., Ahmedabad), and recombinant streptokinase (produced by Shasun Drugs, Chennai) marketed as several brand names eg. 'Klotbuster' (Alembic) and 'LupiFlo' (Lupin). His team has also developed a novel life-saver thrombolytic drug (Clot-specific streptokinase), India's first bio-therapeutic molecule which is not a Biosimilar. This life-saver drug has been patented worldwide and licensed to a US Pharma company for which the commercial launch is expected in 2016. Recently, the team led by him developed fourth-generation 'Anti-thrombotic' clot busters - the first of its kind in the world. Born on March 2, 1956, Dr Sahni is a PhD from Indian institute of Science (IISc), Bangalore. His post PhD career included a stint each in University of California, Santa Barbara, CA, USA: Postdoc Trainee 1984-86; Rockefeller University New York, USA: Sr. Research Associate and Adjunct Faculty 1986-88; and Albert Einstein College of Medicine, New York: Sr. Research Associate 1987-91, before he joined CSIR-IMTECH in 1991 and became its Director in 2005. Dr. Sahni is internationally recognized for his research contributions. He has been the author of several papers published in high impact refereed scientific journals and has a number of national and international patents to his credit. He is Fellow, Indian National Science Academy, New Delhi; Indian Academy of Science, Bangalore, and NASI, Allahabad; Fellow, Association of Microbiologists of India; and Member, Guha Research Conference. Amongst the many awards he has received for his contributions, the most important ones are: National Biotechnology Product Development Award 2002, CSIR Technology Shield 2001-2002, The Vasvik Industrial Award 2000, Ranbaxy Award in Pharmaceutical Sciences 2003, Vigyan Rattan Award 2014, Shri Om Prakash Bhasin Award 2013, and CSIR Technology Award for Business Development and Technology Marketing 2014. ]]> <![CDATA[Innovative solutions for global food challenges]]> https://biospectrumindia.com/news/95/7690/innovative-solutions-for-global-food-challenges.html https://biospectrumindia.com/news/95/7690/innovative-solutions-for-global-food-challenges.html Wed, 26 Aug 2015 16:13:14 +0530 Ultimately, this scenario leads to the overarching question on how to feed this hungry planet. That's why, from 24-27 August in Canberra, Australia, Bayer and the Australian youth organization Future Farmers Network bring together 100 young thought leaders, aged 18-25, from 33 countries for the Youth-Ag Summit to exchange on the role science and modern agriculture play in feeding a hungry planet. During the Summit, young leaders connect with each other, listen to inspirational speakers, exchange ideas in breakout sessions and experience agriculture during field trips. They make a pledge to develop local solutions for local conditions and act as agricultural ambassadors in their home countries. Taking into account this pressing issue of the growing world population, interactive sessions during the Summit will focus on sustainability, leadership and innovation, largely shaped by the essay topics the delegates handed in during the application phase. "We are very pleased to co-host this once-in-a-lifetime event", says Ms Georgie Aley, Chair, Future Farmers Network. "I believe that young people have so much potential to contribute to solutions on global and local food challenges. We look forward to an open dialogue and to hearing their ideas and perspectives." "This is the second Youth Ag-Summit and we are delighted to continue our movement in Canberra today. Australia is a key country in terms of modern agriculture and an ideal host for this event", says Mr Bernd Naaf, Member of the Board of Management, Bayer CropScience. "We are very proud to have such bright minds and great organizations on board to commonly build a sustainable global network of future leaders and strong partners in agriculture." India has sent two delegates for the event. They are: Mr Rohit Fenn from Kottayam, Kerala and Mr Raja Kumar Bollem from Vishakhapatnam, Andhra Pradesh. Their essays and submissions were selected by a panel of judges, who scored candidates on their demonstrated passion for agriculture, environmental stewardship and suggested solutions for global challenges. Mr Justin Whittle, a delegate from Australia says "I was thrilled to hear that I will be one of the lucky youth to attend the Summit. Food Security is my passion and I cannot wait to meet all the other international delegates." Ms Amanda Kharisma, a delegate from Indonesia adds: "For me, this is such a valuable experience. I hope to bring home lots of ideas to contribute to the advancement of my country." The Summit provides a platform for young leaders to discuss challenges and develop solutions - small and large scale. This is reflected in the outcomes of the event. Personal commitments are expressed in the development of the "3 little things". These are individual challenges on food and agricultural issues which delegates want to address back home in their local communities. The other main outcome is the "Canberra Youth Ag Declaration", a global call for action to help solve the pressing issues in modern agriculture. The Declaration will be presented at the UN's Committee on Food Security in Rome from 12-15 October where Bayer, as a member of the private sector mechanism, is hosting a side event. ]]> <![CDATA[Merck confirms shutting Bangalore Genei facility]]> https://biospectrumindia.com/news/95/6971/merck-confirms-shutting-bangalore-genei-facility.html https://biospectrumindia.com/news/95/6971/merck-confirms-shutting-bangalore-genei-facility.html Wed, 26 Aug 2015 16:12:10 +0530 The company confirmed with BioSpectrum that the production at the facility had been stopped since July 31, 2015, and that the decommissioning activities are in progress. As part of Merck Millipore's (the life sciences tools division of Merck KGaA) strategy, it has been decided to stop supply of GeNei products and close the Merck Bangalore Site 02 - GeNei facility, said the company's spokeswoman. GeNei was involved in the manufacturing of reagents, lab wares and chemicals, and was started by Dr P Babu in the eighties. GeNei was later acquired by Merck in 2009, which was part of Sanmar Group, an Indian conglomerate MNC now valued at US $1 billion, headquartered in Chennai. Sanmar's business sectors include chemicals, engineering, and shipping. Moving forward, Merck Millipore will continue to focus on its core businesses building on the inherent strengths in genomics, proteomics, cell culture, cell analysis, western blotting, disease research tools, analytical sample preparation and bio chemicals. The site employed 39 full-time employees and 12 contract personnel. The company said that Merck's management has been in detailed dialogue with the impacted employees, supporting their transition, and evaluating possible alternate opportunities. Despite the shutdown, Merck stated that, for it, India has, and will be a priority market, and will continue to be so. In June 2014, Merck Millipore erected its first Solid Dose Formulation Lab in Mumbai, outside Europe. According to Merck's Q2 2015 reports, Indian and Chinese markets have been its main growth drivers, with APAC region recording net sales at 33%, followed by Europe at 31%, and North America at 20%. In January 2014, AstraZeneca announced the shutting down of its iconic Avishkar R&D site in Bangalore. In August 2014, Indian healthcare giant Piramal officially announced its decision to shut its Mumbai R&D unit. Recently, Pfizer's Thane plant was also written-off for shutting down its operations. Sandoz too, vocalized its plans to lockup its Turbhe site in Maharashtra, this year. ]]> <![CDATA[Pfizer-Hospira deal gets final approval ]]> https://biospectrumindia.com/news/95/6256/pfizer-hospira-deal-gets-final-approval-.html https://biospectrumindia.com/news/95/6256/pfizer-hospira-deal-gets-final-approval-.html Wed, 26 Aug 2015 12:07:07 +0530 Pfizer has announced that the US Federal Trade Commission (FTC) terminated the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended, with respect to Pfizer's pending acquisition of Hospira. The FTC's clearance is contingent upon Pfizer's commitment to divest four the US sterile injectable assets, including Acetylcysteine, Clindamycin, Voriconazole and Melphalan. In addition, Pfizer announced that Brazil's Superintendency-General of CADE has published its unconditional clearance decision. "We are pleased to have received these final regulatory approvals for our pending acquisition of Hospira," said Mr Ian Read, chairman and chief executive officer, Pfizer. He added, "We now look forward to combining our two companies and expect the transaction to close in early September." ]]> <![CDATA[AZ inks combo clinical trial pact with Peregrine Pharma ]]> https://biospectrumindia.com/news/95/4624/az-inks-combo-clinical-trial-pact-with-peregrine-pharma-.html https://biospectrumindia.com/news/95/4624/az-inks-combo-clinical-trial-pact-with-peregrine-pharma-.html Tue, 25 Aug 2015 11:19:26 +0530 AstraZeneca has announced that it has entered into a clinical trial collaboration with Peregrine Pharmaceuticals. The partnership is to evaluate the safety and efficacy of Peregrine's investigational phosphatidylserine (PS)-signalling pathway inhibitor, bavituximab, in combination with AstraZeneca's investigational anti-PD-L1 immune checkpoint inhibitor, durvalumab (MEDI4736). The planned Phase I/Ib trial will evaluate the safety and efficacy of bavituximab in combination with durvalumab in multiple solid tumours. AstraZeneca and Peregrine will collaborate on a non-exclusive basis, to evaluate the combination of bavituximab and durvalumab with chemotherapy as a potential treatment in various solid tumours. The Phase I part of the trial is expected to establish a recommended dose regimen for the combination and the Phase Ib part of the trial will assess the safety and efficacy of the investigational combination. The initial trial will be conducted by Peregrine. Bavituximab and durvalumab are investigational immunotherapies with different mechanisms that assist the body's immune system in fighting cancer. Mr Robert Iannone, head of Immuno-Oncology, Global Medicines Development, at AstraZeneca said, "We believe that combination therapy in immuno-oncology has the potential to be a novel and highly effective approach to treating cancer. Our partnership with Peregrine provides the opportunity to explore an exciting, novel combination that could deliver important clinical benefit to patients across a range of cancers." Mr Steven W King, president and chief executive officer of Peregrine said, "Data generated to date have shown significant potential for combining bavituximab with agents targeting the PD-1/PDL-1 pathway and we're excited to further explore this approach in studies with durvalumab. AstraZeneca, with its biologics arm MedImmune, is a recognised leader in the immuno-oncology field and this collaboration will play a key role as we continue to fully explore the potential of bavituximab in combination immunotherapies for a variety of clinical applications." ]]> <![CDATA[MSF urges negotiators to drop harmful provisions from RCEP agreement]]> https://biospectrumindia.com/news/95/7567/msf-urges-negotiators-to-drop-harmful-provisions-from-rcep-agreement.html https://biospectrumindia.com/news/95/7567/msf-urges-negotiators-to-drop-harmful-provisions-from-rcep-agreement.html Mon, 24 Aug 2015 17:43:10 +0530 As the trade ministers of the 16 countries negotiating the Regional Comprehensive Economic Partnership (RCEP) meet in Kuala Lumpur this week to finalize modalities in the deal, MÃ©decins Sans FrontiÃ¨res/Doctors Without Borders (MSF) is calling for the removal of damaging intellectual property provisions in the deal that would risk locking in high drug prices and endangering the health of millions of people across the globe. To date, nine rounds of negotiations have taken place. The leaked text of the proposal put forth by Japan and other developed countries includes harmful intellectual property provisions such as patent term extensions, data exclusivity, lowering the bar on patentability criteria, and excessive IP enforcement, all of which extend monopoly protection beyond what is required by existing international agreements. Ms Leena Menghaney, Head, South Asia, MSF Access Campaign said, "Treatment scale up for diseases like HIV and TB has only been made possible in many developing countries due to the availability of affordable generic drugs manufactured in India. The world is now looking at India again to provide affordable generic medicines such as those used in the treatment of hepatitis C, which affects up to 150 million people worldwide. "If India and other negotiating countries accept the proposed text on intellectual property rights being pushed in RCEP, it will roll back public health safeguards enshrined in international and national laws, and will put in place far-reaching monopoly protections that restrict generic competition and make medicine prices unaffordable for millions of people who need them." ]]> <![CDATA[Now, compare healthcare costs before availing any treatment]]> https://biospectrumindia.com/news/95/7559/now-compare-healthcare-costs-before-availing-any-treatment.html https://biospectrumindia.com/news/95/7559/now-compare-healthcare-costs-before-availing-any-treatment.html Mon, 24 Aug 2015 15:48:36 +0530 It is an innovative platform for patients to connect with doctors, clinics & hospitals in a very effective way. This web-based platform simplifies the health care selection process for the patients. On the other hand it provides a powerful medium to health care service providers to disseminate information about their expertise & reach out to thousands of patients not only in the same city but around the world. It is a win-win approach for both patients and health-care service providers. This web and smart phone based App will help patients to request for appointments 24/7. Confirmation emails and messages will be sent to their mobile phones. The process will also expand the health care market as thousands of patients who ignore their health due to cumbersome or no appointment system now feel more comfortable to get themselves treated by health-care service provider of their choice. Majority of the patients spend lots of time, money and energy to get this basic information. Since 83% of Indian population is uninsured or under insured, sensitivity towards health care cost is very high. Average patients visit several hospitals, wait in unending queues, undergo pain and mental agony to find cost of surgery. All this can now be done online by uploading medical records. Patients can compare health-care cost estimates and then take informed decisions. Currently majority of the patients are seeking advice from their colleagues, friends or neighbors to find right hospitals and doctors for them. With this portal, patients will be able to take their own decisions by researching more about health care providers on-line. Power of finding the right health-care provider will shift to the patient directly. The portal is neutral about any given health-care provider and will not recommend any particular health-care service provider. Health-care providers will be able to increase their reach and visibility to thousands of patients around the globe and attract more medical tourists in the country. One of the weak links currently is access to aggregated and authentic information to the patients outside India and these kind of portals will help bridge the gap. The platform has has 20,000+ doctors and hospitals listed in 230 cities in India. With its gaining popularity, it is expected that this number should double by end of this year. ]]> <![CDATA[Global Multiple Myeloma treatment market value to approach $9 bn by 2021]]> https://biospectrumindia.com/features/95/7131/global-multiple-myeloma-treatment-market-value-to-approach-9-bn-by-2021.html https://biospectrumindia.com/features/95/7131/global-multiple-myeloma-treatment-market-value-to-approach-9-bn-by-2021.html Fri, 21 Aug 2015 17:39:15 +0530 The company's latest report states that this increase, which will occur across the eight major markets of the US, UK, France, Germany, Italy, Spain, Japan and Canada, will be driven primarily by rising multiple myeloma prevalence as a result of an aging population. Additionally, approvals during the forecast period for drugs that will supplement current market leaders, such as Revlimid, and offer improved therapeutic options, mainly in the relapsed/refractory setting, will also boost the market. Promising examples include ixazomib, ARRY-520 (filanesib), elotuzumab and daratumumab. Mr Yasser Mushtaq, senior analyst, GBI Research, says: "Although multiple myeloma remains incurable, greater understanding of its underlying cellular and molecular biology has driven novel therapy development, with clinical outcomes improving significantly as a result. "While some late-stage pipeline drugs will have a low impact, others have demonstrated promising clinical results in specific patient populations, including elotuzumab and daratumumab. These products are therefore likely to provide physicians with increased choice and complexity in multiple myeloma treatment over the forecast period." However, the analyst adds that various market barriers, such as a limited target patient population, will restrict any further growth in the multiple myeloma therapeutics arena by 2021. Mr Mushtaq explains: "Multiple myeloma's rarity and designation as an orphan disease limits the available treatment population, in turn hindering the potential revenues that can be generated from this indication. This, combined with high drug development costs, can deter manufacturers from investing in this area. "On the other hand, incentives for orphan disease drug development, along with the ability to reposition drugs from one indication to another, could help to counter these challenges and drive further research into multiple myeloma treatment," the analyst concludes. ]]> <![CDATA[Stem cell therapy pioneer honored]]> https://biospectrumindia.com/news/95/7104/stem-cell-therapy-pioneer-honored.html https://biospectrumindia.com/news/95/7104/stem-cell-therapy-pioneer-honored.html Fri, 21 Aug 2015 17:38:41 +0530 Dr Geeta Shroff is the founder and medical director of Nutech Mediworld, the first facility in the world to offer human embryonic stem cell therapy. She received the award for her pioneering work in the treatment of incurable/terminal diseases using human embryonic stem cells. Her groundbreaking work over the past 15 years has helped place India on the map of medical innovation. "For years, finding effective treatment for those medical conditions labeled as 'incurable' or 'terminal' was considered a distant dream. But now, with significant development in the field of stem cells this dream has become a reality," said Dr Geeta Shroff. Human embryonic stem cells are the new frontiers in the field of medical science. They have the advantage of being able to develop into almost every type of cell found in the body and thus offer more promise in treating diseases than other forms of stem cells derived from fetuses, umbilical-cord blood and bone marrow. This technology is being used for treatment of many incurable diseases ranging from Spinal cord injury, Diabetes, ALS, Cerebral palsy, Stroke, Parkinson's disease and others. ]]> <![CDATA[EU nod for Novartis' skin cancer drug ]]> https://biospectrumindia.com/news/95/6108/eu-nod-for-novartis-skin-cancer-drug-.html https://biospectrumindia.com/news/95/6108/eu-nod-for-novartis-skin-cancer-drug-.html Fri, 21 Aug 2015 14:20:02 +0530 Novartis has announced that the European Commission has approved Odomzo(sonidegib, formerly LDE225) 200 mg capsules for the treatment of adult patients with locally advanced basal cell carcinoma (laBCC) who are not amenable to curative surgery or radiation therapy. The EU approval of Odomzo was based on data from the Phase II randomized, double-blind, multi-center BOLT (Basal cell carcinoma Outcomes in LDE225 Trial) study in patients with laBCC not amenable to local therapy or metastatic basal cell carcinoma (mBCC). In patients with laBCC treated with Odomzo 200 mg, the objective response rate (ORR) was 56 percent per central review and 71 percent per investigator review. The median duration of response per central review has not been reached. The median progression-free survival was 22 months per central review and 19 months per investigator review. The most frequent grade 3 and 4 adverse reactions occurring in at least 2 percent of patients treated with Odomzo 200 mg were fatigue, decreased weight and muscle spasms. "We are pleased to have a new treatment option for European patients living with advanced basal cell carcinoma," said Mr Bruno Strigini, president, Novartis Oncology. He added, "This milestone follows the recent approval of Odomzo in the US and is the latest example of our commitment to precision oncology and developing targeted treatments to address unmet needs." The EU approval follows a positive opinion adopted by the Committee for Medicinal Products for Human Use (CHMP) in June 2015 and applies to all 28 EU member states, plus Iceland, Norway and Liechtenstein. Outside the EU, Odomzo is approved in the United States, Australia and Switzerland. Additional regulatory submissions are being reviewed by health authorities worldwide. ]]> <![CDATA[Aurobindo receives FDA approval for ulcer drug]]> https://biospectrumindia.com/news/95/7062/aurobindo-receives-fda-approval-for-ulcer-drug.html https://biospectrumindia.com/news/95/7062/aurobindo-receives-fda-approval-for-ulcer-drug.html Fri, 21 Aug 2015 12:12:40 +0530 Aurobindo Pharma has announced that the company has received the final approval from the US Food and Drug Administration (US FDA) to manufacture and market Omeprazole Delayed-release Capsules USP, 10mg, 20mg and 40mg (ANDA 203270). The approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) Prilosec Delayed-release Capsules, 10mg, 20mg and 40mg of AstraZeneca Pharmaceuticals. Omeprazole Delayed-release Capsules are indicated for short-term treatment of active duodenal ulcer in adults. The product has an estimated market size of $422 million for the twelve months ending June 2015, according to IMS. ]]> <![CDATA[Dr Reddy's recalls its drug in the US ]]> https://biospectrumindia.com/news/95/7073/dr-reddys-recalls-its-drug-in-the-us-.html https://biospectrumindia.com/news/95/7073/dr-reddys-recalls-its-drug-in-the-us-.html Fri, 21 Aug 2015 12:12:03 +0530 Dr Reddy's Laboratories (DRL) is recalling Rivastigmine Tartrate Capsules of 1.5 mg strength from the USA market, due to 'Failed Dissolution Specifications'. A total of 60 bottles of 2952 units are recalled on the direction of US Food and Drug Administration (US FDA). The batch was manufactured at DRL's Bachupally unit. It has been classified as a class-II recall which FDA defined as "a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote." ]]> <![CDATA[Sterigenics acquires LatAm sterilization firm]]> https://biospectrumindia.com/news/95/8180/sterigenics-acquires-latam-sterilization-firm.html https://biospectrumindia.com/news/95/8180/sterigenics-acquires-latam-sterilization-firm.html Thu, 20 Aug 2015 17:04:00 +0530 Sterigenics International, provider of contract sterilization, gamma technologies and medical isotopes, today announced that it has acquired Sao Paulo-based Companhia Brasileira de EsterilizaÃ§Ã£o (CBE), the largest specialist in sterilization and microbial load reduction in Latin America. Founded in 1978, CBE was the first company to employ gamma sterilization methods in Brazil, and offers solutions through the largest particle accelerator (E-BEAM) in Latin America. In 2014, a Sterigenics affiliate acquired Nordion, the world's largest provider of Cobalt-60, an isotope that produces gamma radiation and is a critical component of the gamma sterilization process, creating the only vertically integrated sterilization services company in the world. Additional acquisitions in 2014 included Florida-based gamma irradiation operator FTSI, as well as Gammarad, Italy's leading gamma irradiation sterilization company, which now serves as the company's second gamma sterilization facility in Western Europe. "CBE brings three facilities into our network with a total processing capacity of 12 million cubic feet. With the addition of CBE we now offer six locations for processing in Latin America, including sites in Costa Rica and Mexico," said Mr Philip Macnabb, president, Sterigenics. ]]> <![CDATA[Sun Pharma announces the FDA approval for Ximino]]> https://biospectrumindia.com/news/95/6931/sun-pharma-announces-the-fda-approval-for-ximino.html https://biospectrumindia.com/news/95/6931/sun-pharma-announces-the-fda-approval-for-ximino.html Thu, 20 Aug 2015 12:20:35 +0530 Sun Pharmaceutical has announced that the US Food and Drug Administration (US FDA) has approved its Supplemental New Drug Application (sNDA) for Ximino(Minocycline HCl) extended-release capsules 45 mg, 90 mg and 135 mg. Ximino extended-release capsules are indicated for inflammatory lesions of non-nodular moderate to severe acne vulgaris in patients 12 years of age and older. This approval further strengthens the Company's branded dermatology portfolio in the US. It expects Ximino extended-release capsules to be available for patients during the fourth quarter of 2015. ]]> <![CDATA[Global safety testing for biologics market to touch $3.51 bn in 2020]]> https://biospectrumindia.com/features/95/7827/global-safety-testing-for-biologics-market-to-touch-3-51-bn-in-2020.html https://biospectrumindia.com/features/95/7827/global-safety-testing-for-biologics-market-to-touch-3-51-bn-in-2020.html Wed, 19 Aug 2015 17:03:59 +0530 The global safety testing for biologics market was worth $1.76 billion in 2014 and is projected to reach $3.51 billion in 2020, at a compound annual growth rate of 12.23%. According to market research firm Research and Markets, Pharmaceutical and Biotechnology industries are more concerned over safety of the product, be it in terms of efficacy of the drug, packaging of the product, delivering the product to the customer and others. In all these cases, it is very much important to ensure that the product is safe for the usage. As such, testing place a key role in ensuring the safety of the product. North America leads the global biological safety packaging market with a share of 37.5% in 2014 followed by Europe with 31% of the market share during the same period. On the other hand, Kits and reagents has a market share of 43% while Instruments has a market share of 20%, based on product type. In emerging countries like India, the government is focusing on increasing the growth of biotechnology industry by investing $5 billion every year for the next 5 years starting from 2015. The growth in the end use industries (Pharmaceutical, Biotechnology) are driving this market. Added to this, factors like new innovations in the Biotechnology industry, new drug developments, increased focus on R&D are increasing the growth of safety testing market. Also, government regulations on the quality of the product are also driving the market. ]]> <![CDATA[USFDA approves 'Female Viagra']]> https://biospectrumindia.com/news/95/6865/usfda-approves-female-viagra.html https://biospectrumindia.com/news/95/6865/usfda-approves-female-viagra.html Wed, 19 Aug 2015 14:08:00 +0530 US-based Sprout Pharmaceuticals gained USFDA's approval for Addyi, whose chemical name is Flibanserin, created to enhance sex drive in premenopausal women or women suffering from hypoactive sexual desire disorder (HSDD). Addyi is the first and only FDA-approved treatment for this condition, the most common form of female sexual dysfunction, affecting up to 1 in 10 women in the United States, voiced Sprout. The approval has been granted with strong warnings of effects including low blood pressure and fainting when taken with alcohol. The company said, the most common adverse events among patients treated with Addyi were dizziness, somnolence, nausea, fatigue, insomnia and dry mouth. Hypotension and syncope were seen rarely with Addyi alone but more frequently when Addyi was taken in the morning and when co-administered with alcohol or certain other drugs. "It has been a remarkable journey to get to this breakthrough moment. Today we celebrate what this approval means for all women who have long awaited a medical treatment option for this life impacting condition," said Ms Cindy Whitehead, CEO, Sprout Pharmaceuticals. "We applaud the FDA for putting the patient voice at the center of the conversation and for focusing on scientific evidence." Previously, the drug failed twice to obtain USFDA's approval owing to its side effects. The drug was initially developed by German-based drug maker Boehringer Ingelheim. Once the drug failed FDA's nod, Sprout purchased the drug from Boehringer. In 1998, Pfizer marketed Viagra, a drug designed to address erectile dysfunction in men. Now Addyi is being dubbed as 'Female Viagra'. Palatin Technologies, a New Jersey-based biopharmaceutical company coming up with a similar drug to address HSDD in women. A few groups in the US have raised their opposition against Addyi as a result of its side effects. Addyi is anticipated to be available by October 17, 2015, said Sprout in a statement. ]]> <![CDATA[Novartis partner with AVEO Oncology ]]> https://biospectrumindia.com/news/95/6748/novartis-partner-with-aveo-oncology-.html https://biospectrumindia.com/news/95/6748/novartis-partner-with-aveo-oncology-.html Wed, 19 Aug 2015 12:15:19 +0530 AVEO Oncology has announced an exclusive, worldwide license agreement with Novartis for the development and commercialization of AVEO's first-in-class, potent, humanized inhibitory antibody targeting growth differentiation factor 15 (GDF15), AV-380, and related antibodies, including modified or derivative forms of any such antibody (the "Product"). Under the terms of the agreement, AVEO will receive an upfront payment of $15 million and will be eligible to receive reimbursement, clinical, sales and regulatory-based milestone payments totaling $311 million assuming successful advancement of the Product. AVEO will also be eligible to receive tiered royalties on product sales ranging from high single digits to a low double-digit. Novartis will be responsible for all clinical development, manufacturing and commercialization activities and costs associated with the Product. "AV-380 holds great promise as a potential treatment for cachexia secondary to multiple disease states, including cancer, chronic kidney disease, congestive heart failure and chronic obstructive pulmonary disease," said Mr Michael Bailey, AVEO's president and chief executive officer. He added, "Novartis brings resources and expertise to bear on advancing this program, which we believe provides the optimal path forward toward realizing its full potential." ]]> <![CDATA[Glenmark's new generic gets FDA nod]]> https://biospectrumindia.com/news/95/6678/glenmarks-new-generic-gets-fda-nod.html https://biospectrumindia.com/news/95/6678/glenmarks-new-generic-gets-fda-nod.html Wed, 19 Aug 2015 11:42:56 +0530 Glenmark Pharmaceuticals(Glenmark) has been granted final approval by the United States Food & Drug Administration (US FDA) for Drospirenone and Ethinyl Estradiol Tablets USP, 3 mg/0.02 mg. The drug is the generic version of Yaz Tablets of Bayer HealthCare Pharmaceuticals (Bayer). Glenmark plans to commence shipping of Drospirenone and Ethinyl Estradiol Tablets USP, 3 mg/0.02 mg immediately. According to IMS Health sales data for the 12 month period ending June 2015, the Yaz market achieved annual sales of approximately $170.1 million. ]]> <![CDATA[Novartis completes divestiture of influenza vaccines business]]> https://biospectrumindia.com/news/95/4462/novartis-completes-divestiture-of-influenza-vaccines-business.html https://biospectrumindia.com/news/95/4462/novartis-completes-divestiture-of-influenza-vaccines-business.html Tue, 18 Aug 2015 16:42:18 +0530 Novartis has announced that it has completed the divestiture of its influenza vaccine unit to CSL Limited. This marks the end of a series of transactions previously announced and completed, that are focusing Novartis on its three leading businesses of global scale - pharmaceuticals, generics and eye care. Since April 2014, the influenza vaccines unit results have been reported under Discontinuing Operations in the Novartis consolidated financial statements. Australia's CSL, the world's largest blood products company, has acquired Novartis AG's global influenza vaccine business for $275 million. ]]> <![CDATA[Cipla bidding for Belgian drug maker]]> https://biospectrumindia.com/news/95/6636/cipla-bidding-for-belgian-drug-maker.html https://biospectrumindia.com/news/95/6636/cipla-bidding-for-belgian-drug-maker.html Tue, 18 Aug 2015 16:41:53 +0530 An acquisition which is pegged at $1.3 billion, Indian drug maker Cipla is eying Kremers Urban, the specialty generics drug business of the US $4 billion Belgian drug maker UCB. Initially, Lupin and Torrent Pharma were also contending for the bid, but dropped out later. Kremers sales revenue stood at $463 million for 2014. ]]> <![CDATA[100% placement at Biocon Academy]]> https://biospectrumindia.com/news/95/6625/100-placement-at-biocon-academy.html https://biospectrumindia.com/news/95/6625/100-placement-at-biocon-academy.html Tue, 18 Aug 2015 16:41:00 +0530 The Academy has successfully developed high-end talent of young biotech professionals through an intensive 16-week 'Biocon-KGI Certificate Program in Biosciences' and all of them have been placed at reputed global biotech/ pharma companies, including Biocon and Syngene. During the current placement drive, over 10 biotech companies recruited the students for various functions like production, quality assurance, regulatory affairs, research & development and marketing. A talented pool of 60 aspiring biotechnologists (from Batches 3 & 4) received their certificates from Dr Kiran Mazumdar-Shaw, chief mentor, Biocon Academy during the graduation ceremony held at Biocon Park, Bangalore, on Aug 14, 2015. Dr Kiran said: "We are extremely proud of the young talent being developed at Biocon Academy for the biotech sector. The professional success of these students will inspire many other young biotechnologists to pursue their passion for science. It is very encouraging to see the impact made by the Academy in such a short period. We are now developing new programs which will further enhance biotech learning and prepare them to seek opportunities to excel in the biotech world." Biocon Academy leverages the technical expertise and industrial leadership of Biocon along with the strong academic excellence of its international education partner Keck Graduate Institute (KGI) in California, US, to make biotech students industry-ready. Dr Shelly Schuster, president, Keck Graduate Institute, said: "It is indeed a proud day today for the students who have successfully completed the Biocon-KGI Certificate program in Biosciences. KGI & Biocon Academy, through this intensive and profound engagement are providing high quality academic training to biotech graduates. We are immensely proud of these students who are the future leaders of pharmaceutical and biotechnology industry and will also be the brand ambassadors for KGI and Biocon Academy." Eight students of Biocon Academy's third and fourth batches were presented with 'Gold Medals' for Academic Excellence, while 19 students, who demonstrated extraordinary talent in other areas during Group Projects, Class Assignments, among others., were given the 'Kudos Awards.' Since its inception, the Academy has successfully developed high-end talent of 120 young biotech professionals through an intensive 16-week 'best-in-class' 'Biocon-KGI Certificate Program in Biosciences'. ]]> <![CDATA[Merck inks oncology pact with MD Anderson Cancer Center ]]> https://biospectrumindia.com/news/95/6569/merck-inks-oncology-pact-with-md-anderson-cancer-center-.html https://biospectrumindia.com/news/95/6569/merck-inks-oncology-pact-with-md-anderson-cancer-center-.html Tue, 18 Aug 2015 13:07:02 +0530 Merck and The University of Texas MD Anderson Cancer Center has announced that they have entered into a strategic clinical research collaboration to evaluate Merck's anti-PD-1 therapy, KEYTRUDA (pembrolizumab), in combination with other treatments, such as chemotherapy, radiation therapy and/or novel antitumor medicines. Under the terms of the agreement, collaborative studies will be conducted in the following tumor types: gastroesophageal adenocarcinoma, pancreatic adenocarcinoma, and hepatocellular carcinoma -- over the three year period of the collaboration. The first studies are scheduled to start enrolling later this year. The agreement aims to define what combination modalities will work best with KEYTRUDA in these types of tumors by exploring promising new alternatives. The studies will be conducted in parallel, in order to determine optimal regimens in the most efficient manner possible. All studies will feature state-of-the-art monitoring protocols and built-in flexibility to take advantage of the very latest information available. "Through these types of collaborations, we are able to engage in larger, more comprehensive studies that aim to accelerate the pace of discovery. We believe that this new agreement will help to speed delivery of new cancer treatments that our patients expect and deserve," said Dr Patrick Hwu, division head, cancer medicine at MD Anderson. "This agreement embodies Merck's commitment to collaborating with leaders in the field to rapidly advance breakthrough science and further the goal of bringing new treatment approaches to patients. Agreements like this are an integral part of our strategy to evaluate KEYTRUDA in multiple tumors and combinations," said Dr Roger Dansey, senior vice-president and therapeutic area head, oncology late-stage development, Merck Research Laboratories. ]]> <![CDATA[Camson files patents for 'Natural Fertilizer']]> https://biospectrumindia.com/news/95/3793/camson-files-patents-for-natural-fertilizer.html https://biospectrumindia.com/news/95/3793/camson-files-patents-for-natural-fertilizer.html Mon, 17 Aug 2015 17:56:17 +0530 This is a breakthrough step wherein Natural Fertilizer has the capacity to replace synthetic fertilizer throughout the world. Being a clean technology it also addresses the concerns about the toxicity, safety and the environment issues facing the world. Camson has filed the following patents for the manufacture of NPK (Nitrogen, Phosphorous and Potash): ï‚§ 2826/CHE/2015 titled 'Phosphorus Fertilizer composition and method of producing the same by microbial fermentation technology'.ï‚§ 2827/CHE/2015 titled 'Nitrogen Fertilizer composition and method of producing the same by microbial fermentation technology'.ï‚§ 2828/CHE/2015 title 'Potassium Fertilizer composition and method of producing the same by microbial fermentation technology'. The efficacy of this Natural Fertilizer is at par with any synthetic chemical used by the farmers currently. Camson has the capabilities to manufacture this in large commercial quantities for meeting the increasing global demand without polluting the environment (or ecosystem). This fertilizer is made from microbes available within the environment (e.g. soil, water, air) and the derivation is absolutely natural, hence, when applied it leaves zero residue in soil. It is water soluble and can easily be supplied through drip irrigation. Furthermore, it does not harm the soil topography and is completely safe for perpetual use by the farmers. Commenting on the development, Mr Santosh Nair, CEO, Camson Biotechnologies, said: "We continue to be the pioneer in the field of innovation and organic farming. It will be extremely helpful to the agri-input industry which is overly dependent on imported synthetic water soluble fertilizers (NPK). Our joy is manifold as we have the capacity of making any combination of NPK depending on the soil type. These products will also be very economically competitive in the market place. Our water soluble Natural Fertilizer has been tested and found to be very effective as compared to synthetic water soluble fertilizer as per the data received from DRR, Hyderabad, and MPKV, Rahuri, Maharashtra." Eventually, on a macro level, this product/technology may help the Indian government save a significant amount spent on subsidy for import and sale of chemical fertilizers. Mr Dhirendra Kumar, MD and CSO, Camson BioTechnologies said: "The unique method to produce NPK through the microbial route is a yet another testimony to Camson's R&D prowess. The Government of India's continuous support for the 'Make in India' campaign will provide the necessary fillip to the growth of these revolutionary Natural fertilizers." ]]> <![CDATA[ HITLAB Innovators Summit 2015 highlights health tech innovation in India]]> https://biospectrumindia.com/news/95/6247/-hitlab-innovators-summit-2015-highlights-health-tech-innovation-in-india.html https://biospectrumindia.com/news/95/6247/-hitlab-innovators-summit-2015-highlights-health-tech-innovation-in-india.html Mon, 17 Aug 2015 12:54:34 +0530 More than 100 world-class healthcare and technology experts met recently at the IIT, Delhi on August 07, 2015 for the HITLAB Innovators Summit India, exchanging transformational ideas on digital health. The conference culminated in the HITLAB World Cup India, which rewarded three winners for original concepts designed to improve healthcare access and delivery in India and across the globe. "We were honored to host this exciting event, which featured a variety of healthcare experts, all of whom shared our mission to address pressing global healthcare challenges," said Dr Nishita Rai, Executive Director of HITLAB, a healthcare innovation and teaching lab. "Both the Summit and World Cup serve to accelerate much-needed digital health innovations affecting all aspects of care. We are grateful to our sponsors, Medtronic and HealthStart, for their support, which will result in true change for patients and providers alike." Luminaries included Guest of Honor Sanjiv Kumar, Executive Director of the National Health Resource Center and WHO Collaborating Center India; Keynote Speaker Shailja Dixit, Executive Director, Global Health Economics and Outcomes Research, Actavis; Keynote Speaker Supten Sarbadhikari, Project Director, Centre for Health Informatics, National Health Portal, India; Kaustubh Patil, Medtronic India Development Centre (Bangalore), Anurag Asthana, Site Director- Medtronic India (R&D Centre Hyderabad) ; M.P. Gupta, Professor at IIT; Guruprasad S., General Manager, Healthcare Practice, Robert Bosch Engineering Solutions, India; Rahul Mullick, Chief Technology Officer, India Programs, Bill & Melinda Gates Foundation; and many others. They exchanged ideas on: â€¢ Technology trends and their ability to revolutionize Indian healthcareâ€¢ Not-for-profit models in healthcare and their impact on Indian societyâ€¢ Investment strategies for innovation adoption in healthcareand much more. "Digital health, mHealth, and medtech are moving at a tremendous pace in India, demonstrating the potential to revolutionize health delivery and outcomes in the country," said Ms Laura Pugliese, Manager, Innovations at HITLAB. "It was fascinating to see government groups, multi-lateral agencies, pharmaceutical companies, private investors, startups, foundations, universities, hospitals, and medtech corporations interact at the Summit, all of whom are working toward a common goal: improving the impact and reach of mobile and digital health technologies." Mr Sahil Kapoor, Manager, HITLAB India and Summit Director, announced the winners of the HITLAB World Cup India. Mr. Kapoor noted, "Finalists in this challenge represent the best in healthcare innovation, offering new approaches that are not only visionary but practical. Our World Cup produced inspiring ideas with real-world applications." "HITLAB is more than encouraged not only by the ideas that were elicited at our Summit in India, but also by public response to the event, which has gained much attention on social media and in academic circles," said Rai. "We're looking forward to our signature event December 3-4, 2015, the HITLAB Innovators Summit in New York City, where transformational ideas will no doubt continue to emerge." Winners received seed funding of 20,00,000 INR and mentorship from HealthStart India. They are: â€¢ KiviHealthKiviHealth is a health-tech start-up that aims to provide an affordable, patient-centric, digital health information management system that can be used across multiple clinics, hospitals, labs and pharmacies. With a vision for "One Patient, One Record," KiviHealth provides patients with access to their health information, brings more clarity to medical management, and enables doctors to make superior medical decisions. â€¢ iMed IndiaiMed India is solving the problem of real-time information flow between multiple stakeholders in the pharmaceutical supply chain by using state-of-the-art mobile and cloud computing technology. By integrating the end consumers, retailers, stockists, and pharmaceutical companies, iMed India promises to cut the cost of medicine distribution and eliminate waste by 40% to 60%. â€¢ MyDermacyMyDermacy.com is the world's first personalized lifestyle platform for people searching for solutions to their daily skin and hair concerns from discovery to delivery with the help of qualified dermatologists. HITLAB is an innovation and teaching lab dedicated to improving the quality and accessibility of healthcare worldwide. We help leading organizations ideate, create, and evaluate technology-based solutions to pressing healthcare challenges. ]]> <![CDATA[Canadian authority clears Pfizer-Hospira deal]]> https://biospectrumindia.com/news/95/7194/canadian-authority-clears-pfizer-hospira-deal.html https://biospectrumindia.com/news/95/7194/canadian-authority-clears-pfizer-hospira-deal.html Mon, 17 Aug 2015 12:52:55 +0530 Pfizer has announced that the company has been granted approval from the Canadian Competition Bureau with respect to its pending acquisition of Hospira. As part of its agreement with the Canadian Competition Bureau, Pfizer has committed to divest certain assets in Canada. "We are pleased the Canadian Competition Bureau concluded its review of the transaction and approved the pending combination of Pfizer and Hospira. We continue to work cooperatively with the regulatory agencies to obtain the requisite approvals, and continue to expect the transaction to close in the second half of 2015," said Mr Ian Read, chairman and chief executive officer, Pfizer. Completion of the transaction remains subject to governmental and regulatory approvals in certain other jurisdictions and other usual and customary closing conditions. ]]> <![CDATA[Genmab inks antibody pact with Novo Nordisk ]]> https://biospectrumindia.com/news/95/6434/genmab-inks-antibody-pact-with-novo-nordisk-.html https://biospectrumindia.com/news/95/6434/genmab-inks-antibody-pact-with-novo-nordisk-.html Mon, 17 Aug 2015 12:52:25 +0530 Genmab has announced that it has entered an agreement to grant Novo Nordisk commercial licenses to use its DuoBody technology platform, to create and develop bispecific antibody candidates for two therapeutic programs. The bispecific antibodies will target a disease area outside of cancer therapeutics. Under the terms of the agreement, Genmab will receive an upfront payment of $2 million from Novo Nordisk. After an initial period of exclusivity for the two target combinations, Novo Nordisk has an option to maintain exclusivity or take the licenses forward on a non-exclusive basis. Genmab is entitled to potential development, regulatory and sales milestones of up to approximately $250 million for each exclusive license, or approximately $200 million for each non-exclusive license. In addition, Genmab will be entitled to single-digit royalties on sales of any commercialized products. "Our proprietary DuoBody technology can be used to create bispecific antibodies that target a wide variety of disease areas. Today's agreement with Novo Nordisk is an example of how we can leverage access to our unique state-of-the art antibody expertise and collaborations to generate diverse revenue streams in areas beyond cancer," said Dr Jan van de Winkel, chief executive officer of Genmab. This agreement is not expected to have a material impact on Genmab's 2015 financial guidance. The DuoBody platform is Genmab's proprietary technology platform for the discovery and development of bispecific antibodies. ]]> <![CDATA[India to build a new AYUSH hospital in Delhi]]> https://biospectrumindia.com/news/95/7577/india-to-build-a-new-ayush-hospital-in-delhi.html https://biospectrumindia.com/news/95/7577/india-to-build-a-new-ayush-hospital-in-delhi.html Mon, 17 Aug 2015 12:48:00 +0530 India's biggest AYUSH hospital, built on the lines of All India Institute of Medical Sciences (AIIMS) is scheduled to be completed in Delhi in the next six months. Union Minister of State for AYUSH Mr Shripad Naik said the hospital will cater to 500 patients. The upcoming six AIIMS hospitals across the country will also have separate AYUSH departments in their premises. "Our mission is to build one AYUSH hospital in each district so that people can take the benefits of traditional medicines," said Mr Naik. He further added that medicinal practices under AYUSH and allopathy can be used simultaneously for setting up better healthcare facilities in the country. The Indian government, in its efforts to promote Ayurveda, yoga and other such traditional sciences, has also recently signed pacts with various other countries for cooperation in promotion and research of yoga and ayurveda. The government has also commissioned research studies to document evidence showing AYUSH can be used for treatment of various lifestyle diseases like diabetes and hypertension. The Indian health ministry is also planning to regulate AYUSH medicines and is formulating a plan to set up a separate vertical under the existing pharmaceutical regulator to monitor quality and efficacy of AYUSH medicines available in the country. ]]> <![CDATA[Govt to spend Rs 1750 crore on modernizing regulator, industry welcomes move]]> https://biospectrumindia.com/news/95/6716/govt-to-spend-rs-1750-crore-on-modernizing-regulator-industry-welcomes-move.html https://biospectrumindia.com/news/95/6716/govt-to-spend-rs-1750-crore-on-modernizing-regulator-industry-welcomes-move.html Fri, 14 Aug 2015 10:46:30 +0530 On August 12, 2015, the cabinet committee on economic affairs (CCEA), chaired by the Prime Minister, Mr Narendra Modi, approved the proposal for strengthening the drug regulatory system both at the central and the state levels at a total cost of Rs 1750 crore. The note from Press Information Bureau stated that the strengthening or up-gradation of the system will be spread over a period of three years. Out of the total amount of Rs 1750 crore, an amount of Rs 900 crore will be spent on strengthening central structures that mainly includes the Central Drug Standards Organization (CDSCO). The rest of Rs 850 crore will be made available to the state governments, after signing a Memorandum of Understanding. During his exclusive chat with BioSpectrum a few months back, Dr G N Singh, drug controller general of India (DGCI) had hinted at a revamp in offing. "2015 is going to be a year of streamlined regulations. The industry is upgrading its capacity and skills. Capacity building is a major thrust of the government of India when we are going to have the regulatory frameworks, tools, setups in place. We intend to graduate to the next level and in 2-3 years, we would be better placed. The government has taken proactive steps. We had the strength of 40 inspectors in 2008 and now it has gone upto 347. There will be the addition of 200 more in next 2 years. The basic issue is to train them as per current national and international expectations. Government is supporting us the regulations stringent yet streamlined'" he had commented. Industry terms it positive step In his first reaction, Dr P M Murali, president, Association of Biotechnology Led Enterprises (ABLE) expressed utmost pleasure at this decision. "ABLE is delighted to understand that the Prime Minister has decided to allocate 1750 crores for regulatory matters. This is the most forward looking activity done by any government in the past two decades. A much needed investment and the Industry is thankful," he told BioSpectrum. Responding to BioSpectrum's Rahul Koul on Twitter, Dr Kiran Mazumdar Shaw, CMD, Biocon too was upbeat over the government's decision. On being asked whether it is enough for revamp, she mentioned, "Yes. Infact a lot has improved within the regulatory structure and has been made more transparent and simplified." India is one of the largest manufacturers of drugs and exports pharmaceutical products to over 200 countries or economies. The implementation of the scheme will facilitate domestic manufacture of quality medical products and help establish a robust industry in the field of medical devices, biologicals and other areas. The common training programmes for regulatory and laboratory staff will also help in evolving uniform practices throughout the country. Where will the funds go? The funds are expected to be strategically used to help the centre and state drug regulatory departments in their capacity building measures, like construction of new drug and food testing laboratories, expansion of the existing facilities and hiring manpower. "The planned provision of additional funding to strengthen the drug regulatory system at both the central and state level is welcome, opined Dr Anant Bhan, researcher, Global Health and Bioethics and adjunct professor, Yenepoya University. "It's good to see that these funds will be spent on enhancing the regulatory infrastructure (labs, equipment etc) and also to hire new personnel as well as enhance training facilities," he added further. Assistance will be provided to the states for strengthening their drug regulatory structures. The measure will help enhance quality, safety and efficacy of drugs and other medical products manufactured in the country, and thereby help mitigate the disease burden as also increase export of pharmaceutical products from India. Besides, it will also help trigger growth of the domestic medical devices sector. Dr Jitendra Verma, managing director, Lifecare Innovations suggested the ways in which funds could be used appropriately. "There is need to identify at least five universities or academic centers for M. Pharm with curricular contents including testing/analysis, quality control, quality assurance, regulatory affairs, and pharmacovigilence, said Dr Verma. He added further, "Training centers must be created in different parts of the country for training and refresher programs of the regulatory officials and MSME personnel. Cold chain infrastructure may be strengthened to ensure uninterested cold chain from Production to consumption. Infrastructure should be strengthened to ensure un-interrupted power supply at the time of granting manufacturing licences. This authority and responsibility with accountability may be given to state drugs controllers." The CDSCO is expected to bear the 75 per cent of total expenditure of the projects undertaken by the state drug regulatory departments will be borne by the centre, whereas 25 will have to be borne by the state governments. Funds will help in: âˆ?Up-gradation including provision of additional equipment and manpower in existing drug testing laboratories;âˆ?Setting up of new laboratories for testing drugs, medical devices and cosmetics; âˆ? Making mobile drug testing laboratories available; âˆ? Creation of additional manpower for regulatory structures, including for new and emerging areas such as stem cell, regenerative medicine, biologicals and medical devices in addition to drugs. âˆ? E-governance and information technology enabled online services. âˆ? Training academy for regulatory and drug testing officials, of both the central and state governments. ]]> <![CDATA[J&J partners with Alligator Bioscience ]]> https://biospectrumindia.com/news/95/7196/jj-partners-with-alligator-bioscience-.html https://biospectrumindia.com/news/95/7196/jj-partners-with-alligator-bioscience-.html Thu, 13 Aug 2015 12:59:11 +0530 Janssen Biotech (Janssen), has announced an exclusive, worldwide license agreement with Alligator Bioscience AB for ADC-1013, an immuno-oncology agent currently in Phase 1 clinical studies. The agreement was facilitated by Johnson & Johnson Innovation, London. Under terms of the agreement, Janssen will attain rights to develop and commercialize ADC-1013, an agonistic fully human monoclonal antibody. ADC-1013 targets CD40, an immuno-stimulatory receptor found on antigen-presenting cells such as dendritic cells. Stimulating this receptor initiates a process leading to an increase in T cells attacking a tumor. Alligator Bioscience will receive an upfront payment plus additional milestone payments contingent upon reaching certain pre-determined development, regulatory and commercial milestones. Alligator Bioscience will complete the current Phase 1 dose escalation study and Janssen will be responsible for all subsequent development of ADC-1013, including research, development, manufacturing, regulatory and commercialization activities. In a separate transaction, Johnson & Johnson Innovation - JJDC, Inc. will subscribe for new shares of Alligator stock. "ADC-1013 is a great addition to our growing immuno-oncology portfolio, which includes a broad range of approaches in both solid tumors and hematologic malignancies," said Dr Peter F Lebowitz, Global Oncology Head, Janssen Research and Development. He added, "We were very impressed with the properties of this antibody and we are excited to continue the development that will ultimately deliver it to patients." Based in Sweden, Alligator Bioscience is a privately held biotech company focused on developing innovative antibody-based immunotherapies for the treatment of cancer. The closing is subject to clearance under the Hart-Scott-Rodino Antitrust Improvements Act. ]]> <![CDATA[Long-acting growth hormone deficiency treatments to boost market growth from 2017]]> https://biospectrumindia.com/features/95/6777/long-acting-growth-hormone-deficiency-treatments-to-boost-market-growth-from-2017.html https://biospectrumindia.com/features/95/6777/long-acting-growth-hormone-deficiency-treatments-to-boost-market-growth-from-2017.html Thu, 13 Aug 2015 12:02:09 +0530 The global market for growth hormone deficiency (GHD) treatment will rise in value from $1.26 billion in 2014 to reach approximately $1.88 billion by 2024, representing a moderate Compound Annual Growth Rate (CAGR) of 4.08%, according to research and consulting firm GlobalData. The company's latest report states that the increase, which will occur across the seven major countries of the US, France, Germany, Italy, Spain, UK, and Japan, will be primarily driven by the launch of long-acting growth hormone biobetters, which are expected to begin entering the market in 2017. Dr Lakshmi Dharmarajan, GlobalData's senior analyst covering cardiovascular and metabolic disorders, says the less frequent dosing schedules of these drugs will be attractive to patients, offering improved compliance and adherence outcomes. She comments: "According to Key Opinion Leaders (KOLs), patient compliance with daily growth hormone drugs has been a long-standing issue in the GHD treatment landscape, and it remains the greatest unmet need. "As a consequence, pharmaceutical companies are focusing heavily on developing easier delivery options for patients, leading to therapies that can be administered weekly or bi-weekly. Indeed, nine of the 12 drugs currently in development for GHD are long-acting growth hormone biobetters." The analyst adds that many patients who currently refuse to take their daily growth hormone injections are expected to opt for the long-acting drugs once they become available, which will begin to increase the drug treatment rate. GlobalData forecasts that the global sales for the daily recombinant growth hormone drugs will decline at a negative CAGR of 5.95%, from $1.26 billion in 2014 to $684 million by 2024. However, global sales for the long-acting growth hormone drugs are forecast to reach around $1.2 billion by the end of the forecast period. Dr Dharmarajan continues: "KOL insights indicate that the uptake of these therapies will be faster among adult patients than among children with GHD, as has occurred with long-acting drugs in other markets. "While physicians will initially restrict use of the biobetters in cancer survivors, due to fear of the hormones' lingering effects in this patient population, the overall prospects for long-acting growth hormone therapies are very promising," the analyst concludes. ]]> <![CDATA[National NCD Summit: Experts ask for synergizing efforts to control diabetes]]> https://biospectrumindia.com/news/95/7072/national-ncd-summit-experts-ask-for-synergizing-efforts-to-control-diabetes.html https://biospectrumindia.com/news/95/7072/national-ncd-summit-experts-ask-for-synergizing-efforts-to-control-diabetes.html Thu, 13 Aug 2015 12:01:00 +0530 In light of the growing incidence of diabetes, Confederation of Indian Industry (CII), in collaboration with Eli Lilly and Company (Lilly) released a National White Paper on "Synergizing Efforts in Diabetes Care at the Tertiary Level" at the 3rd edition of the National NCD Summit on August 12, 2015. Dr Jagdish Prasad, Director General of Health Services, Ministry of Health and Family Welfare, Government of India was present to release the white paper. NCD Summit 2015, aimed at creating a national level platform to strengthen public health strategies for comprehensive diabetes management specifically at Tertiary level. Speaking on the occasion, Dr Jagdish Prasad, Director General of Health Services, Ministry of Health and Family Welfare, Government of India, highlighted the fact that India is at risk of becoming the diabetes capital of the world by 2025."Rapid globalization and lack of precautionary measures is the leading cause of diabetes in the country. Education and preventive screening would be key to avoid the burden of diabetes", said Dr Prasad. He stressed on the importance of leading a healthy lifestyle and its impact on diabetes. Our focus should be to avoid becoming the diabetes capital of the world". This year's white paper drafted with support from Population Services International (PSI) is based on the recommendations that emerged from thematic roundtable discussions held in Hyderabad, Delhi, Chennai, Kolkata, Mumbai and Guwahati, around diabetic complications such as Retinopathy, Neuropathy, Gestational Diabetes Mellitus, Cardio Vascular Disease, Nephropathy and Infections including tuberculosis. These regional roundtables witnessed participation from leading endocrinologists, specialists, and policy makers from key government institutes and organizations. These discussions were actively supported by the Ministry of Health and Family Welfare. Mr Edgard Olaizola Story, Managing Director of Lilly India said, "Lilly is committed to making life better for people living diabetes and we have been working to meet the needs of people with diabetes beyond medicines. We realized that increase in the cases of diabetes in the country has led to a growing burden on tertiary-level care hospitals, hence there was an urgent need for initiating a dialogue with stakeholders to strengthen the policies and practices around diabetes management in these facilities. We hope this initiative will help reduces complications related to diabetes. Dr Anupam Sibal, Member, CII National Healthcare Council and Group Medical Director, Apollo Hospitals Group, welcomed the guests at the 3rd edition of the National NCD Summit and the release of the whitepaper. He said, "Non-communicable diseases in general and diabetes in particular would take the center stage for discussion at the summit. The aim of the summit is to strengthen and synergize the efforts of diabetes care at the tertiary level. Technology plays an important role in dealing with the burden of diabetes. Along with that, partnerships with different countries like Europe and United States would contribute to prevent diabetes. Innovation and thinking out of the box would also be pivotal in meeting the challenge of diabetes." Below are some of the highlights from the recommendations that were drawn from the Regional Roundtables which have been published in the National White Paper 2015: · Mandatory screening of complications a must at the time of diabetes diagnosis · Integration of National Programme For Prevention and Control of Cancer, Diabetes, Cardiovascular Disease and Stroke(NPCDCS) and various Government schemes such as Revised National Tuberculosis Control Programme (RNTCP) should be done as this will ensure bilateral screening for diabetes and Tuberculosis · All pregnant women in India should be screened for Gestational Diabetes in early pregnancy · For effective diabetes management, blood glucose, blood pressure and lipid profile must be monitored regularly · Every diabetic patient must get an eye checkup annually · Life style management should be made part of the curriculum of schools · Paramedics should be trained for screening diabetes and its complications and should also be trained on Basic Life Support and Advanced Cardiac Life Support · Employing technology driven tools such as tele-medicine and mhealth for screening and management of diabetes, especially to cater rural population · Primary healthcare centres should be equipped with glucometers, glucose strips, Trop-T, and ECG machines · Need to create awareness amongst general public to remove fear of insulin and ensure therapy compliance · Enhance the health care facilities by means of insurance policies, free medicines and insulin which can be implemented through collaboration of government, public and private partnerships (PPPs) CII and Lilly had convened the 1st National NCD Summit in 2013 and published a National White Paper to suggest mechanisms for strengthening the NPCDCS program. In 2014, the 2nd National NCD Summit was organized with the objective to shape Diabetes Policies in Public Sector Enterprises (PSEs). These two national white papers received significant appreciation from policy makers and practitioners. ]]> <![CDATA[Dr Reddy's launch new generic drug]]> https://biospectrumindia.com/news/95/7186/dr-reddys-launch-new-generic-drug.html https://biospectrumindia.com/news/95/7186/dr-reddys-launch-new-generic-drug.html Thu, 13 Aug 2015 12:00:30 +0530 Dr Reddy's Laboratories has announced that it has launched PRAMIPEXOLE dihydrochloride extended-release tablets, in the US market, following the approval by the United States Food and Drug Administration (US FDA). Pramipexole is used for treating the signs and symptoms of Parkinson disease. The drug is a therapeutic equivalent generic version of MIRAPEX ER (pramipexole dihydrochloride) extended-release tablets. Dr Reddy's PRAMIPEXOLE dihydrochloride extended-release tablets are available in 0.375 mg, 0.75 mg, 1.5 mg, 3 mg and 4.5 mg in bottle count sizes of 30. The MIRAPEX ER brand and generic had the US sales of approximately $48.3 Million MAT for the most recent twelve months ending in June 2015, according to IMS Health. Dr Reddy's PRAMIPEXOLE dihydrochloride extended-release tablets are available in 0.375 mg, 0.75 mg, 1.5 mg, 3 mg and 4.5 mg in bottle count sizes of 30. ]]> <![CDATA[Cipla introduces a new respiratory inhaler]]> https://biospectrumindia.com/news/95/6263/cipla-introduces-a-new-respiratory-inhaler.html https://biospectrumindia.com/news/95/6263/cipla-introduces-a-new-respiratory-inhaler.html Wed, 12 Aug 2015 12:32:02 +0530 Cipla has announced it will soon launch an innovative inhaler which will bring important benefits for physicians, patients and healthcare providers on managing Obstructive Airway Disease (OAD). The new inhaler is called Synchrobreathe which is a novel, breath-actuated inhaler (BAI) with a dose counter. According to the company, Synchrobreathe is very simple to use and eliminates coordination challenges, which is the biggest issue faced by patients using conventional pressurized metered dose inhalers (pMDIs). The inspiratory flow required to trigger the inhaler mechanism is low, which makes its use attractive to a large number of patients whether young, elderly or patients suffering from severe conditions. Synchrobreathe is a BAI with built-in dose counter which allows patients to track doses, thereby encouraging patient compliance. At the South Africa Thoracic Society (SATS) Conference in Cape Town, South Africa (7-10 August 2015) around 200 healthcare providers, pulmonologists, thoracic surgeons and other specialists heard about Cipla's innovation in caring for patients with Obstructive Airway Disease. Mr Frank Pieters, global head of respiratory for Cipla said, "Simple and intuitive, Synchrobreathe is an innovation in managing respiratory disease. Synchrobreathe is attractive for patients as the inhaler is easy to use effectively. Equally importantly, Synchrobreathe will help cut the time healthcare providers need to spend to train patients in correct inhaler use. With this simple inhaler, the healthcare professional knows the patient will be able to use it easily and get the full benefit from every dose." Mr Paul Miller, CEO Cipla Medpro, South Africa said, "South Africa has amongst the highest asthma mortality rates in the world. As a leading company in the area of Respiratory health in South Africa, we are proud to announce the development of this innovation for the first time to the medical community at the SATS congress. Synchrobreathe will definitely make patients' lives easier in managing their Obstructive Airway Disease. Synchrobreathe is in line with Cipla's commitment to bring innovative products and inhalers to best fit physicians' and patients' needs, thereby advancing healthcare for all. Synchrobreathe is expected to reach the market in the current year." ]]> <![CDATA[HIV Activists from across India hold national consultation]]> https://biospectrumindia.com/news/95/5971/hiv-activists-from-across-india-hold-national-consultation.html https://biospectrumindia.com/news/95/5971/hiv-activists-from-across-india-hold-national-consultation.html Wed, 12 Aug 2015 10:38:54 +0530 HIV AIDS is facing a dwindling focus globally both financially as well as programmatically, and the past two years have witnessed many challenges in all HIV related services including ART treatment, care & support services, and prevention. Recurring supply chain management issues in almost all health commodities have affected the overall quality of life of persons living with HIV (PLHIV) and also HIV prevention work. PLHIV networks in their respective states or districts have tried to raise their voices and demand solutions but a common voice which can build sustainable pressure on concerned authorities is lacking. AIDS Healthcare Foundation (AHF) in collaboration with National Coalition of people living with HIV in India (NCPI+) called for a 3 day 'National consultation' of 40 key PLHIV community leaders from all across the country and other legal and parliamentarian advocacy bodies including Forum of Parliamentarians on HIV/AIDS (FPA) on the 5th, 6th and 7th August 2015 to create this voice and work on a joint action plan with multi-stakeholder participation. Dr Sita Ratna Devi, India Bureau Chief, AHF and the organisor of the event said, "The consultation is intended to reinvigorate the civil society movement for HIV advocacy in India while building a road map for addressing the issues that are acting as a setback to the program. The recent months have exhumed many glaring gaps in the implementation of the HIV program in the country and adequate advocacy, especially from the PLHIV community, is essential to bring back focus of the government for a robust HIV program. The need of the timeis to use innovative and adoptcontemporary methods like community based HIV testing using rapid whole blood test kits and task shifting measures in order to increase accessibility within the community while keeping the implementing costs of the outreach programs low. India definitely can implement these strategies to reach out to a large proportion of the total estimated 2.1 million who are unaware of their HIV status but there needs to be an enhanced political and governmental commitment for the same." Mr Manoj Pardesi, General Secretary, National Coalition of People living with HIV AIDS (NCPI+) in India shared that "treatment is the best tool for prevention available at present but for it to be effective continuous supply of medicines and monitoring kits in ART centres is essential which will require robust logistical and supply chain management systems to be implemented in order to avoid the frequent stock-outs that is plaguing national programme. Without bridging these gaps, treatment expansion, and thus the goal of 20x20, will not be efficiently achieved. The purpose of this consultation identify such gaps and build a strategy to address them through adequate advocacy measures". Mr Oscar Fernandes, MP and President,FPA, shared that "Advocacy through parliamentary discussions and actions has culminated to bring major successful changes in the past. We are hopeful that such consultations will provide us with pertinent tools for bringing more positive changes in policies that could affect many more lives." Speaking on relevant issues where the parliament has already initiated action for change, he also added that "Stigma and discrimination forms a major barrier to the HIV programmatic outreach thus,HIV/AIDS Bill should be passed in both the houses of the parliament. In addition, it needs to be tackled through innovative information, education and communication (IEC) efforts. A concerted effort from multiple stakeholders such as parliamentarians, non-governmental organisations, UN agencies, media and most importantly from communities and civil society has helped to build the momentum on the HIV/AIDS Bill. The Parliamentary Standing Committee on Health and Family Welfare reviewed the Bill and has submitted its report, and we are confident that significant progress will be made on this very important legislation." Mr Rashid Alvi, Senior leader, INC and Founding member Forum of Parliamentarians on HIV/AIDS present at the event said, "I am concerned on dilution of the HIV/AIDS prevention efforts in the country. Over the last decade, with the efforts of all stakeholders, HIV infections have reduced remarkably by 57%. We don't have current estimated figures for HIV/AIDS but, I am afraid that reduction in budgets for AIDS programme, reorganization of National AIDS control programme may be devastating for the country in long term. The issue of HIV/ AIDS is above the party lines, and I urge the government to pay due attention to the issue related to HIV." Dr Nochiketa Mohanty, Country Program Manager, AHF India present at the consultationsaid, "This is a part of AHF's 20x20 global campaign to scale up access to antiretroviral therapy (ART) for at least 20 million people globally by year 2020. It is a call to action for those who won't sit on the sidelines as 23 million people living with HIV suffer and die without life-saving medication. The larger objective of the initiative is to change the global mindset of people towards HIV testing and investing in treatment scale up that would eventually yield humanitarian and economic benefits". Currently only 13.6 million people out of an estimated 36 million people living with HIV/AIDS worldwide are on ART, which is far too low. Millions of people still die of AIDS-related causes every year because they cannot get the medicine they need. ]]> <![CDATA[L-Day: Syngene shares soar superb]]> https://biospectrumindia.com/news/95/8135/l-day-syngene-shares-soar-superb.html https://biospectrumindia.com/news/95/8135/l-day-syngene-shares-soar-superb.html Tue, 11 Aug 2015 14:11:29 +0530 Shares of Syngene International, a CRO and a subsidiary of biopharmaceutical behemoth Biocon, were listed at Rs 295 today, against its issue price of Rs 250 per share, on the Bombay Stock Exchange (BSE) and National Stock Exchange (NSE). Its shares opened at 18% higher, and hit a high of Rs 315 on BSE, up by 26%. In July 2015, through its Initial Public Offering (IPO), Syngene raised INR 550 crore, and was subscribed more than 32-times. ]]> <![CDATA[Soliris may drive Myasthenia Gravis treatment market beyond $550 mn ]]> https://biospectrumindia.com/features/95/5348/soliris-may-drive-myasthenia-gravis-treatment-market-beyond-550-mn-.html https://biospectrumindia.com/features/95/5348/soliris-may-drive-myasthenia-gravis-treatment-market-beyond-550-mn-.html Tue, 11 Aug 2015 13:14:21 +0530 The global market for myasthenia gravis therapeutics is anticipated to more than treble in value from $146.4 million in 2014 to $550.4 million by 2024, driven primarily by the potential entry of Alexion's Soliris during the forecast period, according to research and consulting firm GlobalData. The company's latest report states that while only a small percentage of refractory myasthenia gravis patients would receive Soliris across the seven major markets (7MM) of the US, France, Germany, Italy, Spain, UK, and Japan, the drug has the potential to have a notable impact on growth due to its premium pricing. Dr Melina Reisenberg, GlobalData's analyst covering neurology, says Soliris is expected to launch in the US in 2018, followed by its entry in the five European countries (5EU) and Japan in 2019 and 2020, respectively. She explains: "Patients with refractory myasthenia gravis have a significant need for new targeted treatment options, as they have been unable to achieve disease control with the available therapies. "The results from a Soliris trial in myasthenia gravis patients were promising overall. However, due to the considerable cost of Soliris, reimbursement difficulties are expected and might prevent the drug from fulfilling its commercial potential, especially in the 5EU." Despite the current market being dominated by generics with a low annual cost of therapy, GlobalData forecasts peak year sales of $388.9 million for Soliris across the 7MM in 2024, providing the treatment is approved and reimbursed in all markets. The analyst adds that while opportunities will remain following the anticipated introduction of pipeline drugs, which target a broader myasthenia gravis patient population, including non-refractory patients, the early-stage pipeline is very limited. She continues: "Two other compounds targeting the same signaling pathway as Soliris have the potential to be developed for myasthenia gravis and could offer a more cost-effective alternative to monoclonal antibodies. "However, neither Alnylam's ALN-CC5 nor Akari Therapeutics' (formerly Volution Immuno Pharmaceuticals) Coversin are likely to be investigated as treatments for myasthenia gravis in the near future." ]]> <![CDATA[AZ's Medimmune inks cancer pact with Inovio Pharmaceuticals]]> https://biospectrumindia.com/news/95/7523/azs-medimmune-inks-cancer-pact-with-inovio-pharmaceuticals.html https://biospectrumindia.com/news/95/7523/azs-medimmune-inks-cancer-pact-with-inovio-pharmaceuticals.html Tue, 11 Aug 2015 13:13:05 +0530 AstraZeneca has announced that MedImmune, its global biologics research and development arm, has entered into a license agreement and collaboration with Inovio Pharmaceuticals, a biotechnology company developing DNA-based immunotherapies for cancer and infectious diseases. Under the agreement, MedImmune will acquire exclusive rights to Inovio's INO-3112 immunotherapy, which targets cancers caused by human papillomavirus (HPV) types 16 and 18. INO-3112, which is in phase I/II clinical trials for cervical and head and neck cancers, works by generating killer T-cell responses that are able to destroy HPV 16- and 18-driven tumours. Under the terms of the agreement, MedImmune will make an upfront payment of $27.5 million to Inovio as well as potential future payments upon reaching development and commercial milestones totaling up to $700 million. MedImmune will fund all development costs. Inovio is entitled to receive up to double-digit tiered royalties on INO-3112 product sales. Within the broader collaboration, MedImmune and Inovio will develop up to two additional DNA-based cancer vaccine products not included in Inovio's current product pipeline, which MedImmune will have the exclusive rights to develop and commercialise. Inovio will receive development, regulatory and commercialisation milestone payments and will be eligible to receive royalties on worldwide net sales for these additional cancer vaccine products. Dr David Berman, senior vice-president and head of the Oncology Innovative Medicines unit, MedImmune, said, "Today's collaboration with Inovio leverages our deep internal expertise in the use of vaccines to drive antigen-specific T-cell responses. The unique combination of our broad immuno-oncology portfolio with Inovio's T-cell-activating INO-3112, which enhances cancer specific killer T-cells, has the potential to deliver real clinical benefits for patients." Dr J. Joseph Kim, president and CEO, Inovio, said,"Our licensing partnership with MedImmune represents an important step in executing our immuno-oncology combination strategy and advancing Inovio's cancer vaccine R&D pipeline with a leading cancer immunotherapy company. INO-3112 is progressing, with positive interim data generated in an Inovio-initiated phase I study. We appreciate MedImmune's recognition of our ability to activate best-in-class killer T-cells in vivo and look forward to working with them on this collaboration." This agreement builds on the existing partnership between Inovio and MedImmune on two research and development collaborations in the infectious disease area. Both efforts are funded by the Defense Advanced Research Projects Agency (DARPA) and support R&D focused on Ebola, influenza, and bacterial infections. MedImmune has a strong heritage in infectious disease and vaccine innovation, having developed the first monoclonal antibody approved by the US Food and Drug Administration (USFDA) for the prevention of an infectious disease and the technology that led to the creation of an HPV vaccine. ]]> <![CDATA[Novartis launches Sequadra Inhaler]]> https://biospectrumindia.com/news/95/4690/novartis-launches-sequadra-inhaler.html https://biospectrumindia.com/news/95/4690/novartis-launches-sequadra-inhaler.html Mon, 10 Aug 2015 15:58:10 +0530 Novartis Healthcare Private Limited (NHPL) announced today the launch of Sequadra Inhaler (indacaterol/glycopyrronium) 110mcg/50mcg, a fixed dose combination (FDC) of two bronchodilating active ingredients, indacaterol maleate, a long-acting beta2-adrenergic agonist (LABA) and glycopyrronium bromide, a long-acting anticholinergic (LAMA), for the treatment of Chronic Obstructive Pulmonary Disease (COPD). "NHPL is working hard to optimize this important treatment to Indian patients in a timely way", said Jawed Zia, Country President, Novartis India. "Once daily indacaterol/glycopyrronium combination reduces risk of annual rate of exacerbations by 31% compared to the current standard of care (twice-daily salmeterol + fluticasone combination) in patients with moderate-to-severe chronic obstructive pulmonary disease". Addressing the media, Prof Claus Vogelmeier, Professor of Medicine and Head of Pulmonary Division, Marburg University Hospital, Germany said, "Indacaterol/Glycopyrronium combination will offer these patients a much greater improvement in lung function and health related quality of life. This new therapy will change the management of COPD to the benefit of patients". Indacaterol/glycopyrronium combination was developed for the treatment of COPD for patients in whom treatment with a single long acting bronchodilator (LABA or LAMA) does not provide an adequate control of respiratory symptoms. Indacaterol/glycopyrronium combination has demonstrated a statistically significant improvement in lung function at 2 hours post-dose at Week 26. ]]> <![CDATA[HIV burden overwhelmingly shifts to 'middle-income' countries]]> https://biospectrumindia.com/news/95/4688/hiv-burden-overwhelmingly-shifts-to-middle-income-countries.html https://biospectrumindia.com/news/95/4688/hiv-burden-overwhelmingly-shifts-to-middle-income-countries.html Mon, 10 Aug 2015 15:40:34 +0530 International medical humanitarian organization - Doctors Without Borders/MÃ©decins Sans FrontiÃ¨res (MSF) has warned that middle-income countries (MICs), which will be home to 70% of people living with HIV by 2020, face increasing threats to their ability to access affordable generic medicines, which are crucial to countries' ability to reach the global UNAIDS 90-90-90 targets. "No one can deny the pivotal role that affordable antiretrovirals have played in putting 15 million people on HIV treatment, but as we look ahead to the next 15 million, we see that middle-income countries are increasingly constrained in accessing affordable generic medicines, and this spells disaster for the global HIV response," said Dr Peter Saranchuk, TB/HIV advisor for MSF. The term 'middle-income' is an artificial classification that is not linked to public health realities on the ground - in fact, more than half of MSF's medical programmes are in MICs, including India, Kenya, Myanmar, Republic of Congo and South Sudan. About 70% of the world's poor live in MICs, and sixty percent of people with HIV live in these countries today. "Multiple threats on MICs are converging to form an unprecedented assault on access to medicines," said Ms Leena Menghaney, head of MSF's access campaign in South Asia. "Amongst other threats, some of the most acute come from trading partners - like the US and Japan - who seek to impose intellectual property rules that will block access to generic medicines; and from several donor agencies, including the Global Fund to Fight AIDS, Tuberculosis and Malaria, whose discriminatory policies are moving towards reducing funding for MICs at a time when global HIV targets call for increasing the pace of treatment scale-up." Today, we see that the pharmaceutical industry pricing strategies for antiretrovirals (ARVs) and other medicines, including tiered pricing, voluntary licensing and donation programmes, deliberately exclude middle-income countries, and are almost entirely focused on excluding MICs from accessing the lowest global prices available to low-income countries. This is particularly acute for third-line, or salvage regimens, which are priced out of reach for most countries. For example, the raltegravir, etravirine, darunavir and ritonavir salvage regimen is available at the lowest global price for $1,854 per person per year (ppy), but middle-income countries often pay exponentially more: for example, Myanmar pays $2,929 ppy and Ukraine pays $16,409 ppy. Second-line treatments, and some newer first-line treatments, are also priced out of reach. Later this week, negotiators for the Trans-Pacific Partnership (TPP) agreement will meet in Hawaii to try to finalize terms for a trade pact that will encompass at least 40% of the world's GDP. One third of the 12 TPP countries are developing countries classified as middle-income economies who, if the deal is signed in its current form, would be forced to implement a range of new provisions that will lengthen, strengthen and expand patent and regulatory monopolies for medicines. For example, one proposed rule limits governments' ability to restrict pharmaceutical companies' efforts to pursue abusive 'evergreening' strategies to extend the life of pharmaceutical patents well beyond 20 years. The effect is reduced ability to access affordable generic medicines. Meanwhile, the Global Fund to Fight HIV/AIDS, Tuberculosis and Malaria's 'New Funding Model' relies on a funding allocation formula based in part on income classifications, rather than public health needs. As a result, several MICs such as Ukraine and Vietnam have seen their funding reduced in the 2014-2016 funding period compared to previous years, limiting their ability to reach socially excluded groups. "To make matters worse, India-known as the pharmacy of the developing world for its role in producing affordable generic medicines-is facing its own set of pressures from the US, EU and other governments to roll back the country's progressive patent laws in order to restrict generic competition, in favour of supporting the multinational pharmaceutical industry's monopoly- and profit-driven business models," said Ms Menghaney. "If these policies are allowed to continue, middle-income countries face nothing short of a calamity that poses a major threat to the global HIV response and other health initiatives." ]]> <![CDATA[HerpV, GEN-003 vaccines to drive genital herpes treatment market growth ]]> https://biospectrumindia.com/features/95/7435/herpv-gen-003-vaccines-to-drive-genital-herpes-treatment-market-growth-.html https://biospectrumindia.com/features/95/7435/herpv-gen-003-vaccines-to-drive-genital-herpes-treatment-market-growth-.html Mon, 10 Aug 2015 12:41:19 +0530 The global market value for genital herpes therapeutics will increase from approximately $490 million in 2013 to just under $668 million by 2023, largely driven by the introduction of therapeutic vaccines, HerpV and GEN-003, towards the end of the forecast period. However, the company's latest report states that this expansion, which will occur across the seven major markets (7MM) of the US, France, Germany, Italy, Spain, the UK, and Japan, represents a slow Compound Annual Growth Rate (CAGR) of 3.1%, inhibited by the highly generic nature of the genital herpes treatment space. According to Dr Daian Cheng, GlobalData's analyst covering infectious diseases, while generic antivirals have been present in the genital herpes therapeutic marketplace for several years, the overall impact of generic erosion is still expected to be substantial across the 7MM. Dr Cheng explains: "The low price of generic drugs not only will limit the sales of existing treatment, it also poses an entry barrier for new therapies. GlobalData predicts that the patient share of marketed antiviral drugs will further shift from branded to generic versions by 2023. "Despite these barriers, the rise in the number of treated patients due to natural population increases in the US and five European countries (5EU) will produce moderate market growth. This will be further aided by the launches of Agenus' HerpV and Genocea's GEN-003 during the forecast period." HerpV is expected to be launched in the US in 2019 and GEN-003 in 2021, with both products launching in the 5EU one year after their US entries. As such, their largest impacts in the 5EU will occur after 2023. Although the Japanese market is not anticipated to benefit from the sales of these vaccines, the launch of antiviral drug Amenamevir, which is only expected in Japan during the forecast period, is predicted to make moderate contributions to sales in this country. Dr Cheng continues: "While HerpV will be the first-in-class therapeutic vaccine for genital herpes, GlobalData anticipates a relatively low initial uptake based on available efficacy data, which are not encouraging enough to guarantee rapid adoption. "GEN-003 has shown more convincing efficacy data than HerpV and the vaccine is well-positioned to achieve commercial success. However, key opinion leaders interviewed by GlobalData expressed doubts about GEN-003, citing the need for data from a larger population." ]]> <![CDATA[Lupin opens new R&D facility ]]> https://biospectrumindia.com/news/95/4500/lupin-opens-new-rd-facility-.html https://biospectrumindia.com/news/95/4500/lupin-opens-new-rd-facility-.html Mon, 10 Aug 2015 12:39:41 +0530 Lupin has announced the opening of its new Center of Excellence for Inhalation Research in Coral Springs, Florida. Local and state leaders, including Florida Lieutenant Governor Carlos Lopez-Cantera, Florida Department of Economic Opportunity Director Mr Jesse Panuccio, and Mayor Skip Campbell, were on site to celebrate the opening of Lupin's new facility with a ribbon cutting ceremony. Lupin's new facility will focus on the research and development of inhalation products for the treatment of asthma, allergic rhinitis, chronic obstructive pulmonary diseases and other lung diseases. "We are delighted to be making our mark in South Florida. With the talent and resources this state provides, our Coral Springs expansion will further strengthen our ability to bring quality, affordable pharmaceuticals to patients in the United States and other key markets globally. The new inhalation research and development facility is a significant step forward in our journey to emerge as a global specialty pharmaceutical player," said Ms Vinita Gupta, CEO, Lupin. Lupin's Coral Springs facility was made possible through collaboration among Enterprise Florida, the Florida Department of Economic Opportunity, CareerSource Florida, Broward County and the Greater Fort Lauderdale Alliance. "Lupin's grand opening in Broward County is an example of how our area is creating, attracting and expanding high-wage jobs. The company's South Florida presence strengthens our state's robust life sciences industry cluster and we wish them every success," said Mr Bob Swindell, president and CEO of the Greater Fort Lauderdale Alliance. ]]> <![CDATA[Sanofi, Evotec, Apeiron Biologics enter collaboration ]]> https://biospectrumindia.com/news/95/5653/sanofi-evotec-apeiron-biologics-enter-collaboration-.html https://biospectrumindia.com/news/95/5653/sanofi-evotec-apeiron-biologics-enter-collaboration-.html Mon, 10 Aug 2015 12:39:11 +0530 Sanofi has announced that it has entered a research collaboration and license agreement with Evotec and Apeiron Biologics to discover and develop first-in-class small molecule-based immuno-oncology therapies to treat solid and hematological cancers by enhancing the anti-tumor activity of the human immune system. "Immuno-oncology has emerged as a particularly promising field to create potentially curative treatment options for many cancer patients. Partnering with Evotec and Apeiron Biologics will significantly advance our shared vision toward realizing the full value of these innovative small molecule treatments," said Ms Victoria Richon, VP and Head of Cancer Research, Discovery and Early Development for Sanofi. Based on Evotec's technological expertise and Apeiron Biologics' experience with immunology, the new collaboration will focus on the identification of novel small molecules and their targets to develop next-generation therapies in immuno-oncology. These treatments are expected to complement currently available checkpoint inhibitors. The collaboration is based on the initial successful outcome of a phenotypic high throughput screen of potential compounds for development that was commissioned by Apeiron Biologics and conducted by Evotec. Under the collaboration, Sanofi has the option of screening its own compound libraries to identify new small molecule candidates for development. "We are pleased and proud that our joint efforts in immuno-oncology with Apeiron have led to this partnership with Sanofi. The collaboration is a great example of an efficient translation from early-stage research to pharma development," said Dr Werner Lanthaler, chief executive officer of Evotec. Dr Hans Loibner, chief executive officer of Apeiron Biologics said, "It is encouraging to see that our work, even at an early stage, can attract interest from one of the world's leading, large biopharmaceutical companies. We look forward to applying all the different skills and resources bundled in this collaboration for the benefit of this treatment concept and ultimately for the benefit of patients." Under the terms of the agreement, Sanofi will have sole responsibility for all development, regulatory, commercial and manufacturing activities of the products resulting from the collaboration. Sanofi will support two years of funding for Evotec and Apeiron to conduct the research program, which will include potential early success milestone payments. ]]> <![CDATA[Now, an exclusive Life Sciences job portal!]]> https://biospectrumindia.com/news/95/7506/now-an-exclusive-life-sciences-job-portal.html https://biospectrumindia.com/news/95/7506/now-an-exclusive-life-sciences-job-portal.html Fri, 07 Aug 2015 15:32:36 +0530 A new job portal fully dedicated only to Life Sciences professionals will be officially launched and available on August 10, 2015. DNA JOBS, as is called, is a portal whose architecture has been designed to help solve process inefficiency in the recruitment cycle. "This is a centralized platform, and we have mapped the entire life sciences industry into 24 segments, which are further mapped to different companies and employees. Other generic job portals like Naukri, Monster and Times Jobs are into all the industry segments. There are certain existing pain areas for human resource professionals while completing recruiting," commented Mr Ravi Kshirsagar, founder of Inbiosys, a two-year-old start-up which provides project management consulting services to pharmaceutical and biotechnology companies. The job portals is said to be a part of Inbiosys. The portal's algorithm design will try and offer the closest solution to what is being searched by prospective candidates. It took 7-odd months to develop the portal from conceptualization-to-launch without any external investments backing it up, said the company. According to Mr Kshirsagar, the job portal will considerably reduce the hiring costs and bring down the lead time during hiring process. The portal is expected to cross 30,000 registrations this month. "We are trying to bring research, academia and the industry together in one place," he opined. The idea of launching such a niche job portal stemmed up from his own personal experience, pointed Mr Shirsagar. He remarked, "The launching of the job portal is purely accidental. I started out as a project management consultant, and while I was looking for opportunities I realized it is a major challenge to reach out to the right people in the life sciences industry. Companies, too, are not able to reach out to the right candidates who are hirable." The portal is already tied up with 4 key companies for job postings including Hospira, Stelis Biopharma, Syngene and Theramyt Novobiologics. In the next 30 days after its launch, the portal will have more than 200 job postings, said Mr Kshirsagar. This past July, another similar job portal called BioHiring was launched by a start-up, Clevergene, which again exclusively caters to candidates seeking employment in the pharma, biotech and healthcare space. ]]> <![CDATA[Fabry disease treatment market value to reach $1.25 bn by 2024]]> https://biospectrumindia.com/features/95/7737/fabry-disease-treatment-market-value-to-reach-1-25-bn-by-2024.html https://biospectrumindia.com/features/95/7737/fabry-disease-treatment-market-value-to-reach-1-25-bn-by-2024.html Fri, 07 Aug 2015 15:06:52 +0530 The global treatment market for Fabry disease will expand in value from $683 million in 2014 to approximately $1.25 billion by 2024, driven primarily by rising physician awareness of the condition and consequently higher diagnosis rates, according to research and consulting firm GlobalData. The company's latest report states that this value increase, which will occur across the seven major markets (7MM) of the US, France, Germany, Italy, Spain, UK, and Japan, represents a moderate Compound Annual Growth Rate (CAGR) of 6.3%. Dr Valentina Gburcik, GlobalData's director of cardiovascular and metabolic disorders, says that alongside increasing diagnosed cases, the market entry of the first pharmacological chaperone for the treatment of Fabry disease, namely Amicus' migalastat, will also boost growth. She comments: "Migalastat is anticipated to launch in the US and five European countries (5EU) in 2017, before entering the Japanese market in 2020. "The patient share for migalastat is not only expected to be captured from existing patients receiving enzyme replacement therapy (ERT), but also treatment-naÃ¯ve patients that have not previously been considered suitable for ERT, including children, and adults with late-onset, less severe cases of Fabry disease." GlobalData forecasts migalastat to garner sales of $165 million across the 7MM by the end of the forecast period, but further growth will be hindered by the drug only being available to Fabry disease patients with mutations amenable to the drug. As a consequence, ERT will remain the standard of care, with sales of Genzyme's Fabrazyme and Shire's Replagal reaching $678 million and $396 million, respectively, in 2024. Dr Gburcik continues: "Of the two ERTs, Fabrazyme will be the market leader, which is attributed to the fact that Fabrazyme is the only therapy approved in the US. "As Fabry disease is a rare, life-threatening condition with debilitating symptoms, ERT has a positive reimbursement status in the 5EU and Japan, and is normally covered by insurance plans in the US. Despite its high price tag, GlobalData believes that ERT will continue to be prescribed and reimbursed as a treatment for Fabry patients," the director concludes. ]]> <![CDATA[Dr Reddy's announces collaboration with Amgen]]> https://biospectrumindia.com/news/95/4226/dr-reddys-announces-collaboration-with-amgen.html https://biospectrumindia.com/news/95/4226/dr-reddys-announces-collaboration-with-amgen.html Fri, 07 Aug 2015 13:02:52 +0530 Dr Reddy's Laboratories has announced that it has entered into a strategic collaboration with Amgen to market and distribute three Amgen medicines in India in the areas of oncology and cardiology. Under the terms of the collaboration, Dr Reddy's shall perform a full range of regulatory and commercial services to seek approval and launch Kyprolis (carfilzomib), BLINCYTO(blinatumomab) and Repatha(evolocumab) in India. The collaboration leverages the capabilities of both companies, combining three of Amgen's innovative therapies with Dr. Reddy's deep understanding of patient and physician needs in India. Dr Reddy's executive vice-president and head of India Business and global business development Mr Alok Sonig said, "We are excited about our strategic collaboration with an innovation powerhouse like Amgen and look forward to making their innovative medicines accessible to Indian patients. Addressing significant unmet needs of patients in oncology and cardiovascular are key areas in India and, therefore, a priority for us at Dr. Reddy's. We believe that good health can't wait and that this is an important milestone for us in our journey as we improve patient care." "We are pleased to be joining forces with Dr. Reddy's Laboratories in order to make Amgen's innovative medicines available to patients in India. Dr Reddy's has significant experience serving oncology and cardiovascular patients in India and shares Amgen's interest in delivering new treatment options to seriously ill patients," said Dr Penny Wan, Amgen vice-president and general manager, Japan Asia Pacific Region. Kyprolis was approved by the US Food and Drug Administration (US FDA) in July 2015, in combination with lenalidomide and dexamethasone, for the treatment of patients with relapsed multiple myeloma who have received one to three prior lines of therapy. BLINCYTO is an example of immunotherapy, a treatment that uses certain parts of a person's immune system to fight diseases such as cancer. The drug is the first approved bispecific CD19-directed CD3 T-cell engager. ]]> <![CDATA[Insourcing IT ops: A new trend in India?]]> https://biospectrumindia.com/features/95/6939/insourcing-it-ops-a-new-trend-in-india.html https://biospectrumindia.com/features/95/6939/insourcing-it-ops-a-new-trend-in-india.html Thu, 06 Aug 2015 17:33:51 +0530 On August 6, 2015, Thermo Fisher Scientific (TFS) inaugurated its first Technology Development Center (TDC) in Bangalore, which will serve as the centre for all of its global IT operations. TFS refused to comment on the investments made in building the center. The TDC will leverage technology platforms like cloud, SAP, J2EE, E1, informatica, testing, web and database. TFS always sought after third-party IT service providers to fulfill its IT needs. It outsourced its IT services to giants including Wipro, Satyam, Deloitte, Cognizant, and Capgemini. According to Mr Manoj Prasad, VP-IT, TFS India, TDC will be involved in TFS' top 5 projects. The TDC was ran as a pilot since 2012, before being developed as a complete IT operations entity. The newly inaugurated TDC now hosts 180 IT professionals, which is expected to reach a headcount to 250 next year. "There is a big focus on hiring directly from college campuses. We have had great responses from IIT-Madras and IIT-Roorkee. Sixty percent of our hires will be from colleges, and 40 percent from the market with experience," said Mr Amit Chopra, MD, TFS India. Hiring directly from campuses offer companies more leverage on its cost-cutting measures. By insourcing IT operations, companies gain more control over the development and execution of projects without having to cope with third-parties' time frame. It also offers a peace of mind to companies since data security issues are a major concern when outsourced. TFS is a $17 billion corporation, which has made investments worth $125 million in India in the last 5 years. In the next few years, said the company, it may open similar centers in other Indian cities including Mumbai and Gurgaon. The TDC is expected to double up its capacity in the next 12-24 months, said TFS. "Availability of skillset, cost, labor and resources in India give us an advantage on cost measures, and enables us to work more efficiently and productively," commented Mr Manoj. On similar lines, in 2014, biopharmaceutical giant AstraZeneca (AZ) insourced its IT operations by opening its Global Technology Centre (GTC) in Chennai worth US $9 million. Till then, IBM served as its IT partner since 2001. ]]> <![CDATA[GSK to invest Rs.1000 crore in a manufacturing facility in Karnataka]]> https://biospectrumindia.com/news/95/1177/gsk-to-invest-rs-1000-crore-in-a-manufacturing-facility-in-karnataka.html https://biospectrumindia.com/news/95/1177/gsk-to-invest-rs-1000-crore-in-a-manufacturing-facility-in-karnataka.html Thu, 06 Aug 2015 13:58:00 +0530 As per reports, British drug giant, GlaxoSmithKline has planned to invest nearly Rs 1,000 crore in setting up a manufacturing facility in Karnataka. The pharma major has been allotted 50 acres by the Karnataka Industrial Area Development Board (KIADB) to set up the unit. The investment proposal was made during a recent meeting of Mr Ian Felton, deputy high commissioner, British High Commission, Bengaluru, and Mr Richard Heald, CEO, UK India Business Council, with Mr K Ratna Prabha, state additional chief secretary, Commerce and Industries Department and Mr B S Shekarappa, KIADB CEO. Established in 1924, GSK is one of the oldest pharmaceutical companies. GSK has two manufacturing units in India, at Nashik and Thane, as well as a clinical development centre in Bengaluru. According to a statement issued by Mr K Ratna Prabha, additional chief secretary to the government of Karnataka, the company will generate 232 jobs at this facility. This will be GSK's first facility coming up in the last 15 years anywhere in the world, the statement added. ]]> <![CDATA[EU nod for Pfizer-Hospira merger]]> https://biospectrumindia.com/news/95/6641/eu-nod-for-pfizer-hospira-merger.html https://biospectrumindia.com/news/95/6641/eu-nod-for-pfizer-hospira-merger.html Thu, 06 Aug 2015 11:38:55 +0530 Pfizer has announced that the European Commission (EC) has approved under the European Union (EU) Merger Regulation the company's pending acquisition of Hospira. The Commission's decision includes Pfizer's commitment to divest certain assets. "We are pleased to have achieved a significant milestone for Pfizer's pending acquisition of Hospira with the EC's approval of the transaction," said Mr Ian Read, chairman and chief executive officer, Pfizer. He added, "We continue to work cooperatively with the regulatory agencies to obtain the requisite approvals, and continue to expect the transaction to close in the second half of 2015." Completion of the transaction remains subject to the expiration of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, governmental and regulatory approvals in certain other jurisdictions and other usual and customary closing conditions. ]]> <![CDATA[Hilleman Laboratories CFO awarded by CIMA ]]> https://biospectrumindia.com/news/95/6402/hilleman-laboratories-cfo-awarded-by-cima-.html https://biospectrumindia.com/news/95/6402/hilleman-laboratories-cfo-awarded-by-cima-.html Thu, 06 Aug 2015 11:38:00 +0530 Mr Naveen Amar, CFO of Hilleman Laboratories, has been honoured with the prestigious '100 Most Influential CFO of India' award presented by Chartered Institute of Management Accountants (CIMA), the world's largest and leading professional body of management accountants for upholding the highest ethical and professional standards and maintaining public confidence in management accounting in association with World CSR & World Sustainability CMO Asia. Mr Amar was also awarded Best CFO of the Year (Pharmaceutical and Biotech) at the gala ceremony held in Mumbai. Speaking on this occasion Mr Naveen Amar, Senior Vice President (Finance, Compliance) and Company Secretary at Hilleman Laboratories mentioned, "I am really blessed to have been honored with two awards. It is a great privilege when your work is recognized on such a large platform. I am grateful and thankful to all those who have been a part of my journey and to everybody at Hilleman Laboratories who are so supportive and believe in me" The award promotes innovative financial strategists who, in today's fast changing digital era, are much more than data analysis. It acknowledges CFOs with a proven track record of performance, achievements and contribution to the business. The nominees were judged on frameworks such as strategic perspective, business goal management, risk management, customer focus and business acumen. On this glorious occasion,Hilleman Laboratories scored big, addinganother feather to its cap by receiving The Best Financial Reporting (Small Business) at the Most Influential CFO's of India Award by Chartered Institute of Management Accountants (CIMA) in association with CMO Asia. ]]> <![CDATA[TNAU, Japanese professors unravel key genetic features of barley]]> https://biospectrumindia.com/news/95/7357/tnau-japanese-professors-unravel-key-genetic-features-of-barley.html https://biospectrumindia.com/news/95/7357/tnau-japanese-professors-unravel-key-genetic-features-of-barley.html Wed, 05 Aug 2015 14:49:26 +0530 Tamil Nadu Agricultural University (TNAU) professor Natesan Senthil and a Japanese professor have together identified the genes responsible for barley's domestication that transformed this once-wild food grain into an item of mass consumption. Their research work was published in the journal Cell on July 30, 2015. Barley was the earliest domesticated crop in the world and the history of barley cultivation is much older than wheat. However, two key, unanswered questions have been asked for a long time, namely - how did the grain dispersal mechanism of wild barley evolve and how often, and where was the dispersal mechanism lost during the process of domestication? Takao Komatsuda of the National Institute of Agrobiological Sciences, Tsukuba, Japan and Kazuhiro Sato of Institute of Plant Science and Resources, Okayama University, Kurashiki, Japan led a group of international collaborators which include Natesan Senthil, Professor of Biotechnology, Tamil Nadu Agricultural University, in the discovery of two genes, Btr1 and Btr2 that are involved in grain dispersal in wild barley at maturity. These genes facilitate seed dispersal, which is essential for the survival of the species, but at the same time it makes harvesting of large amounts of grain virtually impossible. Today, barley is the fourth most important crop in the world - both in the size of cultivation and grain production, and its high production is due to its domestication that happened 10,000 years ago. Takao Komatsuda, senior researcher at the National Institute of Agro-biological Sciences (NIAS), Tsukuba, Japan, explained that there was a problem with the wild variety. The spikes that contain the grain were brittle in the wild variety. This brittle nature breaks the spike, and the grain falls on the ground. While this is essential for the proliferation of the crop, it made harvesting difficult. The rachis lost its brittle characteristic through isolated natural mutation events. These mutations resulted in a stronger, non-brittle rachis through which the grain remained attached to the head after maturity. Ancient farmers recognized that they could now harvest all the grains at the same time and selected the individual, naturally mutated barley plants for cultivation. This was therefore a centrally important step in the domestication of this early cereal crop species. Professors Komatsuda and Sato along with Indian Professor Senthil have elucidated, for the first time, the genetic basis that led to one of the earliest human cropping activities and eventually to modern agriculture. In their research, two great mysteries about the evolution of wild barley and its transition to modern cultivated barleys were unlocked. A natural mutation in one gene (Btr1) resulted in the establishment of cultivated barley in modern Israel about 10 thousand years ago, while an independent mutation in the other gene (Btr2) occurred later in North west Syria and south east Turkey. The descendants of the two mutant, cultivated barleys differ in their nature, and represent a major source of the extremely high genetic diversity that exists in barley today. Now, with this discovery the researchers believe that introducing unused wild barley traits with new properties into the current breeding programs would offer opportunities to accelerate and improve the efficiency of breeding of barley. Commenting on the discovery Professor Senthil said, "Barley that we are using today has been derived from one of the descendants of the first cultivated barleys that originated through either of the two mutations in wild barleys. The modern day descendants carry a large amount of genetic material and associated traits from their ancient ancestors in which the mutations first occurred. For example, traits such as disease resistance, quality in the production of beer, nutrient value of livestock feed will vary greatly depending on breeding lineages. Therefore, it is likely that the efficiency of breeding programs can be accelerated by exploiting used genes and taking advantage of the latest genomic information." The understanding of the genetic features discovered by the researchers will now throw light on increasing the grain production as barley has been extensively used as animal fodder, as a source of fermentable material for beer and certain distilled beverages, and as a component of various health foods. ]]> <![CDATA[Kerala bans Pulmo Plus, a health supplement from British Biologicals for one year ]]> https://biospectrumindia.com/news/95/7617/kerala-bans-pulmo-plus-a-health-supplement-from-british-biologicals-for-one-year-.html https://biospectrumindia.com/news/95/7617/kerala-bans-pulmo-plus-a-health-supplement-from-british-biologicals-for-one-year-.html Wed, 05 Aug 2015 12:37:58 +0530 A prominent health supplement for children, Pulmo Plus, manufactured by British Biological, Bangalore is banned in Kerala for one year by commissioner of food safety on August 3 after multiple complaints. The office of commissioner of food safety, Kerala, has banned the product in the state after follow up inspections done by food analysts, which confirm the presence of living/dead insects in the container and product. The product Pulmo Plus, which is available in six different flavours, is a proprietary health supplement mainly prescribed by doctors for improving health conditions of children. The order reads "Repeated complaints about the presence of insects in different batches of the product are a serious health risk issue warranting prohibition of sale of the product in the entire State. Therefore the Commissioner of Food Safety in the interest of Public Health prohibit, under Section 30(2)(a) of FSS Act 2006, the storage, distribution or sale of Pulmo plus manufactured by British Biologicals, in Kerala for one year from the date of this order or until the required food safety measures were taken by the manufacturer and certified by the Commissioner of Food Safety, Karnataka where the product is manufactured." PulmoPlus is a pulmonary nutrition supplement for children, which is enriched with Bovine Colostrum. Bovine Colostrum contains antibodies, oligosaccharides, growth factors, antimicrobial compounds and immune-regulating constituents, which protects children against recurrent upper respiratory tract infection. In addition to Bovine Colostrum, Pulmo Plus contains Whey Protein concentrate and 24 essential Vitamins and Minerals which helps to enhance the immunity of children as well as faster recovery from respiratory tract infections and other respiratory distress. Based on the first complaint filed by Dileep Nair on March 18, 2015, the sample was forwarded to Food Analyst, Thiruvananthapuram and the Analyst reported that insect larvae and living insects were present in the sample received with manufacturing date September 2014. The second complaint from Prasanth on August 2, 2015 was submitted to the Commissioner of Food Safety and on physical examination of the product it was convinced that living and dead insects were present in the product. The date of manufacture of product was October 2014 and was labelled best before 18 months from the date of manufacture. The 3rd complaint from Shafi P.K on August 3, 2015 was addressed to the Assistant Commissioner of Food Safety, Thiruvananthapuram. The Assistant Commissioner of Food Safety, Thiruvananthapuram after physical examination of the product reported that presence of living and dead insects were noticed in the product. The date of manufacture of product was October 2014. ]]> <![CDATA[Govt's diarrhoea control program gets support from leading NGO, Industry]]> https://biospectrumindia.com/news/95/6079/govts-diarrhoea-control-program-gets-support-from-leading-ngo-industry.html https://biospectrumindia.com/news/95/6079/govts-diarrhoea-control-program-gets-support-from-leading-ngo-industry.html Wed, 05 Aug 2015 11:45:00 +0530 'IDF 2015' is the campaign that aims at reducing child mortality rates in India; one of the prime goals of the Millennium Development Goals (MDGs). By August 8th, this initiative of the National Health Mission aims to conduct intensified activities for control of deaths due to diarrhoea across all States and Union Territories. The strategy is to utilize advocacy and awareness raising activities, distribution of ORS-Zinc and promotion of Infant and Young Child Feeding (IYCF) activities. The aim is to empower communities by improving their knowledge, attitudes, beliefs and practices to prevent diarrhoea. One of the prominent NGOs, Save the Children will work with the Department of Health and Family Welfare in their effort through the ground-breaking and ambitious 'Stop Diarrhoea' programme. Supported by RB, the programme, for the first time will fully implement the internationally recognized 7-point plan to ensure comprehensive diarrhoea prevention, treatment and control across 4 key states - Delhi, Uttar Pradesh, Uttarakhand and West Bengal. The 'Stop Diarrhoea' program combines RB's expertise in product development and research, and Save the Children's experience of delivering life-saving work to help save thousands of young lives a year. As part of the program, the consumer goods company, RB India has also developed two innovative products to improve hand washing and community sanitation. RB will not be making a profit from these products and the revenue will be reinvested into the 'Stop Diarrhoea' program. They will also be produced locally, encouraging entrepreneurship, in addition to reducing the overall carbon footprint and transport costs associated with their manufacture. The 'Stop Diarrhoea' program will provide facilities such as Zinc-ORS depots and breast feeding corners. In addition, street plays, awareness rallies, home visits for demonstrations on ORS and Zinc usage, pocket meetings with mothers, hand washing demonstrations at Anganwadi Centres and schools will also be conducted to raise awareness around diarrhoea prevention. Meetings to engage with stakeholders like government ministries, development partners and health workers will also be an integral part of the plan. As per Mr Thomas Chandy, chief executive of Save the Children India,"The IDCF is a great initiative by the government and we need to have more campaigns like this to strengthen the ongoing effort to reduce childhood mortality. It is also important for civil society organizations and corporate sector to work together with the government to mobilise communities and create awareness about diarrhoea. Our 'Stop Diarrhoea' program supported by RB is being reinforced by these intensive activities. We are happy to support the government in eliminating diarrhoea as a public health burden" Mr Nitish Kapoor,chief executive of RB India, said:"RB has been funding Save the Children programmes in India since 2010 and has been able to see the real difference they have been making to the lives of Indian families. We believe that together RB and Save the Children can make a critical step towards a better understanding of water, hygiene and sanitation, which in turn will help reduce the number of children dying from diarrhoea in India." Childhood diarrhoea continues to be a major killer among children in India, contributing to 10.4 percent of under five deaths in the country, the highest death rate in the world. Around 1.4 lakhs children die due to diarrhoea annually in the country, and it is estimated that 48 percent of Indian children below the age of five years are stunted, with diarrhoea being one of the main causes. ]]> <![CDATA[Hetero launches biosimilar for blood cancer]]> https://biospectrumindia.com/news/95/6968/hetero-launches-biosimilar-for-blood-cancer.html https://biospectrumindia.com/news/95/6968/hetero-launches-biosimilar-for-blood-cancer.html Wed, 05 Aug 2015 11:43:33 +0530 Hetero Group has recently announced the launch of its biosimilar 'Rituximab' under the brand name Maball. It will be marketed and distributed by Hetero Healthcare, a group company of Hetero. The launch of biosimilar Rituximab will provide a much needed access to patients in India suffering with non-Hodgkin lymphoma (NHL) and chronic lymphocytic leukaemia (CLL). Rituximab is recommended as the first-line treatment for NHL and is available in a single dose vial with two strengths - 100mg/10ml and 500mg/50ml. Dr Bandi Parthasaradhi Reddy, CMD, Hetero Group said, "The launch of Maball strengthens Hetero's position in the biosimilar market, and has enabled the company to join select biotech companies with the capability to develop, manufacture and commercialize complex monoclonal antibodies (mAb's)." He added, "Biosimilars is one of the key strategic business areas for Hetero. We have invested in biosimilars and will introduce more biosimilar MAB's in the future. We also have plans to introduce affordable biosimilar Rituximab into key markets outside India through our partners." Rituximab is a monoclonal antibody used alone or with other drugs to treat non-Hodgkin's lymphoma and chronic lymphocytic leukaemia. It is also used for the treatment of other indications such as rheumatoid arthritis. ]]> <![CDATA[Teva acquires 51% stake in Immuneering]]> https://biospectrumindia.com/news/95/6936/teva-acquires-51-stake-in-immuneering.html https://biospectrumindia.com/news/95/6936/teva-acquires-51-stake-in-immuneering.html Wed, 05 Aug 2015 10:53:45 +0530 Teva Pharmaceutical and Immuneering Corporation has announced that the companies have entered into an agreement in which Teva will purchase a 51 percent equity share of the genomic-analysis company. Immuneering uses advanced proprietary techniques to identify hidden signals and biological insights across an array of genetic, genomic, and proteomic data that can direct research for enhanced discovery, development and clinical success. Teva and Immuneering have worked together over the past several years to unlock significant findings into genetic biomarkers, therapy-specific gene expression signatures and breakthrough work in characterizing non-biological complex drugs (NBCDs). Teva's majority holding in Immuneering provides right of first refusal in projects relating to the Company's stated objective of developing, personalizing and improving treatment of disorders of the Central Nervous System (CNS). "Immuneering brings together state-of-the-art analytics know-how with expertise in integrating multiple biologically- and clinically-relevant inputs," said Mr Michael Hayden, president, Teva Global R&D, and chief scientific officer. He added, "Their ability to cut through, link and interpret enormous and disparate data-sets is outstanding. This capability is invaluable in capturing difficult-to-find signals, confirming them in follow-up experiments, and informing decision-making that de-risks and optimizes development of therapeutic approaches. Simply put, by intensifying the relationship between Teva's team, led by Dr. Iris Grossman, and the MIT-trained Immuneering team, we will be closer to helping match the right patient to the right medicine at the right time." "Patients who suffer from CNS diseases urgently need better medicines. Immuneering is pioneering new ways to use gene expression and genomic data to elucidate the biological mechanisms underlying both the development of disease, and the effectiveness of medicines," said Dr Ben Zeskind, CEO and co-founder of Immuneering. He added, "Combining Immuneering's technology platform and expertise with Teva's world-class scientific knowledge, intensity, and devotion to patient benefit is a logical next step to build on the success of the Teva/Immuneering collaborations to date. This partnership represents an unprecedented and exciting new approach to improving the lives of patients with CNS diseases." ]]> <![CDATA[Global Pharma sales to grow beyond $1 trillion]]> https://biospectrumindia.com/news/95/7226/global-pharma-sales-to-grow-beyond-1-trillion.html https://biospectrumindia.com/news/95/7226/global-pharma-sales-to-grow-beyond-1-trillion.html Tue, 04 Aug 2015 16:08:40 +0530 The Intellectual Property and Science business of Thomson Reuters announced the release of the 2015 CMR Pharmaceutical R&D Factbook, the biopharmaceutical industry's leading resource of global R&D trends. Despite concerns around declines in R&D, the analysis identifies a surge in global sales with 2014's $1 trillion milestone and forecasts sales to reach $1.3 trillion by 2018. It also reveals a positive shift in new molecular entities (NMEs) with 46 launches in 2014; the highest in over a decade. The study underscores a promising industry outlook with increases in sales and NME launches and with shifting trends in R&D pipeline volume and therapeutic areas as evidenced by these other key findings: â€¢ Diversification increases NME launches: One third of 2014 launches were for rare indications, mainly within Anti-cancer. More than 65 percent were specialty drugs for the treatment of Anti-cancer, Hepatitis C Virus and HIV. â€¢ Anti-cancer dominates: Anti-cancer development continues to attract the highest amount of investments across all therapeutic areas; with the majority of recent launches receiving orphan drug status from regulatory authorities. â€¢ Increase in failing fast and cheaply: Phase III pipeline volumes are steadily growing due to the improved ability to "fail fast and cheaply," increasing the speed of potentially successful compounds through development. Since 2003, the CMR Pharmaceutical R&D Factbook has been built in collaboration with leading global pharmaceutical companies to assess productivity and to provide insights to strengthen planning and the effectiveness of R&D. It is based on proprietary, primary sources, competitive intelligence, and public sources covering key trends across the landscape, including R&D pipeline volume, success rates, cycle times, regional comparisons, therapeutic areas, and generics. "This is an extraordinary year for the pharma," said Basil Moftah, president, Thomson Reuters IP & Science. "Not only do the critical insights provided by the Factbook challenge negative perceptions, but it demonstrates this industry's continued commitment to creating and employing innovative solutions to tackle its largest hurdles." ]]> <![CDATA[Conservation of medicinal plants: A look at efforts since 2000]]> https://biospectrumindia.com/news/95/7570/conservation-of-medicinal-plants-a-look-at-efforts-since-2000.html https://biospectrumindia.com/news/95/7570/conservation-of-medicinal-plants-a-look-at-efforts-since-2000.html Tue, 04 Aug 2015 14:23:46 +0530 The government of India had set up the National Medicinal Plants Board vide resolution notified on 24th November, 2000 to co-ordinate with ministries, departments, organizations, states and UT governments for development of medicinal plants sector in general and specifically in the areas relating to assessment of demand supply, advising on policy, promotion of conservation, proper harvesting, cultivation, quality control, research and development, processing, marketing of raw material in order to protect, sustain and develop this sector. For overall development of medicinal plants sector in the country the NMPB has been implementing following Schemes since year 2008-09: 1. Central Sector Scheme for "Conservation, Development and Sustainable Management of Medicinal Plants"aimed at providing support for Survey, Inventorization, in-situ conservation, ex-situ conservation / herbal gardens, Research and Development, linkage with peoples collectives like Self Help Groups (SHGs), Joint Forests Management Committees (JFMCs) etc. The Scheme is being continued during the 12th Plan. 2. Centrally Sponsored Scheme of "National Mission on Medicinal Plants"is primarily aimed at supporting cultivation of medicinal plants on private land with backwards linkages, for establishment of nurseries for supply of quality planting material etc. and forward linkages for post-harvest management, marketing infrastructure, certification etc. Currently this Scheme is being implemented as a component (Medicinal Plants) of the National AYUSH Mission (NAM) Scheme of the Ministry of AYUSH. For increasing the availability of medicinal plants in the country, the NMPB under its aforesaid Schemes is mainly supporting the activities / programmes for augmenting the existing resources and cultivation of prioritized Medicinal / herbal plants species. Presently, as such there is no region specific programme / scheme for the cultivation of herbal plants which are endemic to specific region. However, the programme of cultivation of medicinal / herbal plants is being implemented in the States under the Scheme of National AYUSH Mission (NAM). The Scheme is being implemented in a mission mode through Mission Director identified in the States. The State Mission Directors prepare the State Annual Action Plans (SAAP) for cultivation of prioritized medicinal / herbal plants which are being approved by the Directorate of NAM. NMPB supports cultivation of herbal plants by providing financial assistance in the form of subsidy at 30 percent, 50 percent and 75 percent. The endemic and endangered herbal plants are generally kept at category eligible for 75% subsidy, so as to promote their cultivation in a large scale. The 95 prioritized medicinal / herbal plants species under the NAM Scheme is annexed. This information was given by the Minister of State (Independent Charge) of the Ministry of AYUSH, Mr ShripadYessoNaik in reply to an unstarred question in Lok Sabha on July 31, 2015. ]]> <![CDATA[Teva's $40.5 bn Allergan acquisition likely to yield substantial returns]]> https://biospectrumindia.com/features/95/7555/tevas-40-5-bn-allergan-acquisition-likely-to-yield-substantial-returns.html https://biospectrumindia.com/features/95/7555/tevas-40-5-bn-allergan-acquisition-likely-to-yield-substantial-returns.html Tue, 04 Aug 2015 14:13:46 +0530 Under the proposal, Allergan's legacy Actavis global generics business will be spun off and subsequently merged with Teva. The latter company will also accrue generic manufacturing and research and development units, along with third-party supplier Medis and an over-the-counter commercial unit. Teva states that, following the addition of Allergan's generics business, it will have approximately 320 pending abbreviated new drug applications in the US, including around 110 first-to-file applications. Furthermore, the combined company will boast a commercial presence across 100 geographies, including a top-three position in over 40 markets, further cementing Teva's status as a global leader in the generics space. Mr Gianfranco Zeppetelli, GlobalData's deals analyst, says: "GlobalData's valuation puts Allergan's generics business at approximately $40.3 billion, in line with Teva's final acquisition cost. Teva is therefore well positioned to make a substantial return on investment from the deal, given each company's revenue base and cost synergies. Indeed, Teva believes the purchase will lead to cost synergies and tax savings of approximately $1.4 billion annually. "Furthermore, Teva is expecting to achieve annual sales of approximately $26 billion, with earnings of around $9.5 billion in 2016, including estimated revenue of $11 billion outside the US." Teva's bid for Allergan's generics business illustrates that it has given up on its pursuit of rival Mylan NV, with acquisition attempts falling short after Mylan exercised the obscure 'stichting' option under Dutch law as a vehicle to block a potential takeover. Mr Zeppetelli continues: "The transaction will serve to offset Teva's forthcoming revenue shortfall from generic entry to Copaxone (glatiramer acetate), its flagship multiple sclerosis treatment and primary sales generator. "Meanwhile, the deal will allow Allergan to concentrate on its innovative pharmaceutical business, which boasts higher profit margins than generics. Additionally, Allergan will use the capital raised in the deal to reduce its debt accrued from recent M&A exploits and seek further acquisitions, with Biogen rumored to be high on the list of potential targets." Following Actavis' purchase of the Botox maker in March for $70 billion, the former officially changed its name to Allergan, under which its branded portfolio will be positioned. The company has since made some strategic bolt-on acquisitions by signing deals for Kythera BioPharma and Naurex, with both deals complementing Allergan's therapeutic focus around the central nervous system and dermatology, according to GlobalData's analyst. ]]> <![CDATA[India foils UK company's bid to patent use of turmeric, pine & tea for hair loss]]> https://biospectrumindia.com/news/95/7245/india-foils-uk-companys-bid-to-patent-use-of-turmeric-pine-tea-for-hair-loss.html https://biospectrumindia.com/news/95/7245/india-foils-uk-companys-bid-to-patent-use-of-turmeric-pine-tea-for-hair-loss.html Mon, 03 Aug 2015 18:16:25 +0530 India once again has been successful in protecting its traditional knowledge by preventing an attempt made by Europe's leading dermaceutical laboratory, Pangaea Laboratories, to take patent on a medicinal composition containing turmeric, pine bark and green tea for treating hair loss. CSIR-TKDL located the patent application filed at European Patent office by Pangaea Laboratories Limited and filed pre-grant opposition along with prior-art evidences from TKDL, proving that turmeric, pine bark and green tea, are being used as a treatment for hair loss, since long in Indian systems of medicine like Ayurveda and Unani. The above UK based company had filed the patent application at European Patent office in February, 2011. CSIR-TKDL Unit had filed evidences from TKDL on January 13, 2014 after the patent application got published on website, pursuant to which the patent application is finally deemed to be withdrawn by the applicant on June 29, 2015. Till date CSIR-TKDL Unit has achieved success in about 200 such cases without any cost. In recent past, CSIR-TKDL Unit has also foiled an attempt of Colgate-Palmolive Company to patent a mouthwash formula containing herb (Nutmeg- Jayaphal) extract used in Indian traditional systems of medicine to cure oral diseases, at European Patent office. CSIR-TKDL headed by Dr Archana Sharma, submitted proof in the form of references from ancient books in this case, which said the herb and its extracts of Myristica Fragrans were historically used for oral diseases in Indian systems of medicine. ]]> <![CDATA[Did you know India has diabetic friendly rice varieties?]]> https://biospectrumindia.com/news/95/7986/did-you-know-india-has-diabetic-friendly-rice-varieties.html https://biospectrumindia.com/news/95/7986/did-you-know-india-has-diabetic-friendly-rice-varieties.html Mon, 03 Aug 2015 15:56:42 +0530 As per various reports, India would soon be called as the diabetic capital of world. But here is some good news for Indian diabetic patients who eat rice especially in Kashmir and Southern states. As per the information given by the minister of state for agriculture, Dr Sanjeev Kumar Balyan in Rajya Sabha (Upper house of Parliament) on July 31, 2015, the Indian Institute of Rice Research (IIRI), Hyderabad which is the part of Indian Council of Agricultural Research (ICAR) system has identified three rice varieties with low glycemic index (GI) values which are considered suitable for diabetic patients. These varieties are: Lalat (GI=53.17), BPT 5204 (GI=51.42) and Sampada (GI=51). Any variety of rice with â‰¤ 55 GI is considered as diabetic friendly. Presently, these varieties are under cultivation in different states of India. ]]> <![CDATA[Govt plans central regulatory regime for Ayush drugs]]> https://biospectrumindia.com/news/95/6090/govt-plans-central-regulatory-regime-for-ayush-drugs.html https://biospectrumindia.com/news/95/6090/govt-plans-central-regulatory-regime-for-ayush-drugs.html Mon, 03 Aug 2015 15:56:10 +0530 The government is considering setting up of a structured central regulatory regime for Ayush drugs. In this regard, the current proposal is to have a vertical structure for Ayushin the CDSCO. Procedural steps for setting up this structure have been initiated but the timeframe for which cannot be specified at this stage. Presently, the Drugs and Cosmetics Act, 1940 and Rules thereunder have exclusive provisions for AYUSH drugs, which are enforced by the state governments. This information was given by the minister of state (Independent Charge) of the ministry of Ayush, Mr Shripad Yesso Naik in Lok Sabha on July 31, 2015. For regulating the practice of Ayurveda, Siddha, Unani and Homoeopathy, the government has established Central Council of Indian Medicine and Central Council of Homoeopathy under the provisions of Indian Medicine Central Council Act, 1970 and the Homoeopathy Central Council Act, 1973 respectively. ]]> <![CDATA[Strides' cough drug receives USFDA approval]]> https://biospectrumindia.com/news/95/7285/strides-cough-drug-receives-usfda-approval.html https://biospectrumindia.com/news/95/7285/strides-cough-drug-receives-usfda-approval.html Mon, 03 Aug 2015 14:56:14 +0530 Bangalore-based pharma company Strides Arcolab announced that it has received approval from the United States Food & Drug Administration (USFDA) for Benzonatate Capsules USP, 100 mg and 200 mg. Benzonatate is used to treat coughs caused by the common cold and other breathing problems (for example, pneumonia, bronchitis, emphysema, and asthma). It works by reducing the reflex in the lungs that causes the urge to cough. According to IMS data, the US market for Benzonatate is approximately US $41 million. The product will be manufactured at the company's oral dosage facility at Bangalore, and marketed by Strides in the US Market. The product will be launched immediately, said the company in a statement. ]]> <![CDATA[Medtronic launches resolute 'Onyx' drug eluting stent in India]]> https://biospectrumindia.com/news/95/7990/medtronic-launches-resolute-onyx-drug-eluting-stent-in-india.html https://biospectrumindia.com/news/95/7990/medtronic-launches-resolute-onyx-drug-eluting-stent-in-india.html Sat, 01 Aug 2015 12:31:00 +0530 With Rs 61.5 Mn Coronary Heart Disease (CHD) patients in 2015, India becomes one of the largest contributors of CHD patients in the world. By 2020, India is expected to have the largest disease burden in the world and shall account for 1/3rd of the deaths. Approximately 9-10 percent of the CHD patients suffer from an acute coronary event, accounting for 4-5 million cases of Acute Coronary Syndrome. Optimizing the treatment of coronary artery disease with a new foundation for future stent innovations, Medtronic on July 31, 205 announced the launch of the Resolute OnyxTM Drug-Eluting Stent (DES) in India. "With the new Core Wire technology, the Resolute Onyx DES sets a new standard for durable polymer DES. It is a revolution in stent technology that allows for improved deliverability in extremely tortuous arteries and enhanced conformability because of the flexible design, greater radiopacity and thinner struts", said Shamik Dasgupta Vice President Cardiac and Vascular Group, India Medtronic.Built on the proven clinical performance and superior deliverability of the Resolute Integrity DES, the Resolute Onyx DES is the first stent to feature a new advancement called CoreWire Technology that allows it to have a denser core metal wrapped in a cobalt alloy outer layer. This new technology enables increased radiopacity (i.e., visibility during the procedure). Radiopacity is a very important feature and refers to a metal's ability in being opaque to one or another form of radiation, such as X-rays. Radiopaque objects block radiation rather than allow it to pass through making them visible on X-rays. Resolute Onyx DES has thinner struts to help improve deliverability without compromising radial and longitudinal strength. Resolute Onyx DES features PowerTrac technology, a new delivery system that was introduced earlier this year with the NC EuphoraTM Noncompliant Balloon Dilatation Catheter. The result is a revolutionary new DES that provides superior deliverability which means it is exceptionally easy to navigate the stent through the tortuous and narrowed arterial segment that requires treatment. This makes it easier to address the needs of patients with complex cases who require better deliverability and tracking. This technology further reduces the force that is required to navigate the stent into the patient's anatomy thereby giving enhanced procedural confidence. CoreWire Technology is the next new DES advancement after Continuous Sinusoid Technology (CST), which was previously introduced with the Resolute Integrity DES and the Integrity bare-metal stent. CST is a method of stent manufacturing that molds one single strand of wire into a sinusoidal wave enabling a continuous range of motion. "Deliverability of a coronary stent has always been the mainstay in providing acute results during PTCA. Through an innovative Medtronic-developed process, Resolute OnyxTM DES is manufactured from a single strand of core wire into a sinusoidal wave form that provides a fluid range of motion without compromising the structural strength", said Managing Director & Vice President South Asia for India Medtronic, Mr. Milind Shah. Resolute Onyx expands Medtronic's interventional cardiology portfolio of medical devices across Coronary, Renal Denervation and TAVI, and is the latest in a series of 12 new product introductions planned over the next two years. In collaboration with leading clinicians, researchers and scientists, Medtronic offers the broadest range of innovative medical technology for the interventional and surgical treatment of cardiovascular disease and cardiac arrhythmias. The company strives to offer products and services that deliver clinical and economic value to healthcare consumers and providers worldwide. ]]> <![CDATA[â€œOne step forward, three steps back: The curious case of agri-biotech regulation in Indiaâ€?]]> https://biospectrumindia.com/views/95/6626/one-step-forward-three-steps-back-the-curious-case-of-agri-biotech-regulation-in-india.html https://biospectrumindia.com/views/95/6626/one-step-forward-three-steps-back-the-curious-case-of-agri-biotech-regulation-in-india.html Sat, 01 Aug 2015 09:35:00 +0530 Recently, it was reported that Indian scientists have completed final field trials of a genetic modified mustard and will soon submit their final report to the government. This would be the second food crop after Bt Brinjal for which all studies have been completed and waiting for the government approval to be the other crops besides cotton going the GM way. One can't help but review the regulatory situation in the 5 years that has passed by between the time of Bt Brinjal in 2010 and GM mustard in 2015. It's fair to say that regulatory situation in India has become very challenging in the last five years. It is very commendable that the field trials of GM mustard have been completed. The year 2010 was the beginning of the uncertain times for agricultural biotechnology in India when a moratorium on the commercialization of Bt Brinjal was announced despite satisfying all the criteria set up the regulatory authorities. The apex regulatory body to review and approve all biotechnology products in India went through a name change from being Genetic Engineering Approval Committee (GEAC) to Genetic Engineering Appraisal Committee (GEAC), a change that did not alter the acronym but significantly devalued its authority. Since then, it has become extremely difficult to even conduct field-research to evaluate the usefulness and safety of GM crops. In 2011, the GEAC introduced another condition for obtaining a No Objection Certificate (NOC) from individual states before planting the research trials. This new condition, took everyone by surprise and resulted in the loss of a complete year. And if that wasn't bad enough, the ecosystem for field research worsened even further 2013 onwards when the GEAC, that was earlier convening every month, stopped meeting on a regular basis adding to the uncertainty of the industry. Meanwhile, our neighbours in the region continued to advance their research and development to review and approve GM crops. Philippines has been the leader and continued to approve GM crops. Last year Vietnam approved GM maize for cultivation and Indonesia continued to develop its drought resistant sugarcane, issued food and environmental safety certificates in 2013 and allowed uninterrupted field trials of other crops such as maize. Pakistan also continued to conduct and completed large scale field trials of several crops. It is worthy to note that Vietnam started the trials of maize much later and approved these ahead of India mainly because the predictability in the regulatory system that they developed. The most interesting of all is Bangladesh. While India imposed a moratorium on Bt Brinjal, Bangladesh continued its multi- location field trials of its own varieties of Bt Brinjal (the same event developed in India) and commercially began planting Bt Brinjal in 2014. Interestingly, Bangladesh cited the safety results for this event conducted in India. Similarly, crop biotechnology has progressed well in Africa. Unfounded criticism The critics of crop biotechnology cite several reasons in support of delays in India. First there's the MNC bogey - the so called over-reliance of imported technology and dependence on foreign technology. However, it is Indian institutions that have suffered the most because of these delays in the last 5 years. GM mustard, like Bt Brinjal was developed in India for Indian conditions so it will be interesting to see the response there is to GM mustard as field trials come to an end. Another argument against biotech crop is that only 28 countries grow biotech crops and more than 80% percent of the planted area is in only four countries. But these critics perhaps do not know that India is in the list of these four countries with just one crop Bt cotton and the 28 countries that grow these crops constitute around 60% of the world's population! And many more countries import GM foods from the GM producing countries. Health and safety concerns are also cited as the reasons why we should not progress with biotechnology. It should be noted and has been reported several times that of the GM crops have been planted and consumed across the world for so many years, there has not been even a single case of adverse affect on human health. The opinion of the scientific community linked to a petition submitted by 250 scientists to the Prime Minister to stop GM research in the country, is yet another reason cited by critics against the introduction of this technology. However several noted science bodies such as the National Academy of Agricultural Sciences (NAAS) under the chairmanship of Professor M S Swaminathan passed a resolution endorsing the usefulness of biotechnology in agriculture. Scientists at this year's Indian Science Congress also submitted a similar petition to the Prime Minister. Interestingly the Honourable Prime Minister also recently spoke in favour of GM crops. So it is hoped that the normalcy would resume in field testing of biotech crops. We must realize that India is one of very few select countries in the developing world that has the scientific knowledge and capability to develop biotech crops on its own which is exemplified in the number of applications by the public sector has put up for field trials. India's regulatory system is one of the most stringent in the world and if allowed to evaluate the applications purely on its merit, India can continue to establish its leadership in this domain. Our universities and institutes have developed a large human resource in biotechnology, which will decline if agricultural biotechnology is not allowed to develop further and take us back by several years. This capability needs to grow and continuing field research will be a very significant step in this direction. The last 5 years have been very uncertain. It is hoped that the next coming years will be progressive and not retrogressive for crop biotechnology research in India. ]]> <![CDATA[Introducing the 'PfizerKline Empire']]> https://biospectrumindia.com/features/95/8455/introducing-the-pfizerkline-empire.html https://biospectrumindia.com/features/95/8455/introducing-the-pfizerkline-empire.html Sat, 01 Aug 2015 09:03:00 +0530 This past May, Deutsche Bank analyst Mr Gregg Gilbert sent a note to the clients writing, 'Introducing PfizerKline', catalyzing an unprecedented adrenalin rush among pharmaceutical industry giants and investors around the world. "....As evidenced by Pfizer's interest in AstraZeneca last year, one important goal for Pfizer has been to seek a deal that would maximize access to its balance sheet and improve its tax structure," Mr Gilbert wrote. He also pointed that this potential combination could be 'materially accretive' to earnings per share and discounted cashflow. According to the calculations, the deal would be valued at an enormous US $146 billion. Appealing British cos The deal would grant Pfizer major tax benefits, as the company would move its legal address to the UK instead of the US, lowering its corporate tax rate in the process. British drug makers seem appealing mainly because they are in a lower corporate tax region compared to the US. Estimates have put Pfizer's offshore cash at nearly US $70 billion, which is held outside the US, so the company does not pay the 35 percent US corporate tax rate. "This is not the first time that Pfizer has attempted a tax-inversion deal, however. Last year, the US drug giant was in a hostile pursuit of UK drug maker AstraZeneca (AZ), in a deal worth nearly $120 billion. This would have been the industry's biggest ever acquisition. However, Pfizer faced stiff opposition from the US Treasury, which had tightened regulations and effectively made it disadvantageous for Pfizer to go ahead with the deal," explained Mr Gianfranco Zeppetelli, deals analyst, GlobalData, a global research and consulting firm. If Pfizer were to proceed with a GSK takeover, it could face similar opposition from UK politicians, much like it did with the AstraZeneca deal. Both companies have overlapping development programs and Pfizer would gain access to GSK's newly revamped respiratory portfolio, whilst strengthening its vaccine pipeline, potentially making the combined company a vaccine and consumer health powerhouse. Mr Zeppetelli said that GSK has been looking more and more vulnerable recently as sales continue to decline, most notably from its once best-selling respiratory product, Advair, amidst increasing generic competition. "Dutch rival Mylan NV is the latest competitor to add another nail in the coffin, and has recently launched the first bioequivalent copy of Advair, known as Sirdupla," he pointed. The big boy What motivates Pfizer to go really big on its acquisitions like AZ, Hospira and now GSK? The main driving force behind these large acquisitions is Pfizer's key strategy of buying assets that have the potential for creating value in the short term, allowing the company to boost sales rather than sign deals for long-term drug development. "Additionally, Pfizer has seen a shortfall in its topline revenue since its patents on Lipitor and Caduet expired. It will also witness a continued drop in sales due to pending and future patent losses on top-selling drugs Celebrex, Viagra, and Zyvox," revealed Mr Zeppetelli. GSK's battle GSK's first-quarter earnings were unimpressive, and its strategy, headed by its CEO Mr Andrew Witty, is one that leans on slow but steady growth, emphasizing volume sales over highly-priced medicines. However, this tepid growth strategy has not been popular with investors who want ROI in the near term, said the analyst. In addition, GSK's consumer health and vaccines businesses, which the company recently talked up via its sale and swap with Novartis, are lower-margin businesses, meaning that they do not have as high a financial impact as branded prescription drugs. Why overseas firms? One of the main reasons for companies to acquire overseas firms is to move their legal addresses away from the US, thereby lowering their corporate tax rates by a significant margin. Mr Zeppetelli explained, "This enables companies to free up more money, which can be used for other deals, R&D spend, or to return to investors in the form of dividends." Fallen revenues During the past few years, patent exclusivity losses have hit Pfizer really hard. Since 2010, Pfizer's prescription sales have fallen from US $58 billion to US $46 billion in 2014, as a result of patents expiring on key drugs, such as Lipitor, Caduet, Xalatan, Geodon, Celebrex, and Viagra. Pfizer's licensing agreement with Boehringer Ingelheim (BI) to market the COPD (chronic obstructive pulmonary disease) drug Spiriva terminated on a country-by-country basis in 2012, which resulted in a decline in Pfizer's share of Spiriva revenues. This dragged down Pfizer's alliance revenues related to the drug. Based on the midpoint of Pfizer's estimated prescription drug sales of US $43 billion for 2015, the company's Rx sales will have dropped by nearly $15 billion since 2010. Overlapping strengths Respiratory drugs and vaccines for infectious diseases are two main therapeutic areas which overlap between the two pipelines of the duos. GSK is one of the market leaders in respiratory drugs, and its lead product Advair/Seretide accounted for approximately 23 percent of its total revenue in 2014. The British drug maker is also counting on four co-developed COPD/asthma products (Breo/Anoro, Ellipta, Incruse, and Arnuity) to drive growth over the next decade, which would fit nicely with Pfizer's product portfolio. GSK has also strengthened its position as one of the leaders in vaccines, after acquiring the global vaccine business from Novartis last year. Pfizer has found incredible success with its Prevnar vaccine line and, in buying GSK, would truly solidify the combined entity as a vaccine powerhouse. Impact on Indian cos PfizerKline specifically would not have a large impact on the Indian drug market. "However, we do expect that Pfizer would be carving out its Global Established Products (GEP) business unit, which is largely comprised of its generic drugs, along with some biosimilars, and injectables platforms. This segment achieved combined sales of US $25 billion in 2014," Mr Zeppetelli noted. The divesture would be similar to when Pfizer spun off its animal health (Zoetis), nutrition, and Capsugel business units. If the deal is a success, PfizerKline's competitors will remain in the branded drug space in continental Europe. These include AstraZeneca, Novartis, Bayer and, to some extent, Roche, Novo Nordisk and Sanofi. Will GSK give in? Given GSK's financial struggles, loss in market cap, and recent announcements of lay-offs and restructuring, the company's board might be more open to a deal with Pfizer. "The key sticking point will be the political pressure and regulatory hurdles in the UK. GSK has a deeply imbedded infrastructure in the UK, and it will be hard for the citizenry to lose one of its top employers," he commented. Will Pfizer eye Indian drug makers next? "Not really," Mr Zeppetelli added. "We are talking about branded or innovator companies and not generic drug makers. We do expect Pfizer to spin off its GEP business as a separate generics business entity. This business unit will compete directly with the global generic drug manufacturers, namely Teva, Mylan, Sun, Lupin, Cipla and, to some extent, Actavis and Valeant -- although these companies are shifting strategy to more branded drugs." Will Pfizer eye BMS in the future? Or will it approach AZ again later this year? "I don't believe so," concluded Mr Zeppetelli. ]]> <![CDATA[Lupin acquires specialty product portfolio in Germany]]> https://biospectrumindia.com/news/95/7455/lupin-acquires-specialty-product-portfolio-in-germany.html https://biospectrumindia.com/news/95/7455/lupin-acquires-specialty-product-portfolio-in-germany.html Fri, 31 Jul 2015 13:46:36 +0530 Pharma Major Lupin (Lupin) today announced that it has entered into a strategic asset purchase agreement with German-based Temmler pharma, a part of the Aenova Group, one of the world's largest pharmaceutical contract manufacturers, to acquire Temmler's specialty product portfolio subject to certain closing conditions. Temmler has a fast growing specialty portfolio of 13 products including key Central Nervous System (CNS) products and specialty products that address rare disease areas like Myasthenia Gravis, Huntington disease, as well as fast-growing dermatology products for anti-wart treatment. Since Huntington disease has many symptoms ranging from motoric symptoms to personality changes, both Temmler and Hormosan products can be used to treat the disease. Commenting on the acquisition, Ms Vinita Gupta, CEO of Lupin said, "...Temmler's business has a strong strategic fit with Lupin's Hormosan business in Germany and enables Lupin to bring an enhanced specialty CNS portfolio to the German market." Dr Maurice Chagnaud, president - Europe and head of inhalation strategy, commented, "....Temmler operates in niche segments and its specialty product portfolio has strong synergies with Hormosan's existing CNS portfolio. The acquisition not only complements but would also enhance Hormosan's specialty portfolio and enables it to grow into niche therapy areas. ]]> <![CDATA[Former AIIMS CVO awarded Magsaysay Award]]> https://biospectrumindia.com/news/95/6357/former-aiims-cvo-awarded-magsaysay-award.html https://biospectrumindia.com/news/95/6357/former-aiims-cvo-awarded-magsaysay-award.html Thu, 30 Jul 2015 14:32:40 +0530 The Board of Trustees of the Ramon Magsaysay Award Foundation (RMAF) has announced that this year five individuals from India, Laos, Myanmar, and the Philippines will receive Asia's premier prize, the Ramon Magsaysay Award. Mr Sanjiv Chaturvedi, former chief vigilance officer (CVO) at AIIMS is among the winners of this prestigious award. According to the foundation, Mr Chaturvedi is being recognized for "his exemplary integrity, courage and tenacity in uncompromisingly exposing and painstakingly investigating corruption in public office, and his resolute crafting of program and system improvements to ensure that government honorably serves the people of India." Established in 1957, the Ramon Magsaysay Award is Asia's highest honor and is widely regarded as the region's equivalent of the Nobel Prize. It celebrates the memory and leadership example of the third Philippine president after whom the award is named, and is given every year to individuals or organizations in Asia who manifest the same selfless service and transformative influence that ruled the life of the late and beloved Filipino leader. "The Magsaysay awardees of 2015, are truly stoking fresh hopes for a better Asia. Clearly, they are creating bold solutions to deeply-rooted social problems in their respective societies, problems which are most damaging to the lives of those trapped in poverty, ignorance, prejudice, and unjust systems. It is also clear that through their solutions each of these inspiring leaders is building more hopeful lives among their people one smart, impassioned, and persistent step at a time," said RMAF president Ms Carmencita Abella. This year's Magsaysay Award winners will each receive a certificate, a medallion bearing the likeness of the late President, and a cash prize. They will be formally conferred the Magsaysay Award during formal Presentation Ceremonies to be held on Monday, 31 August 2015 at the Cultural Center of the Philippines,to which the public is cordially invited. ]]> <![CDATA[Roche's Atezolizumab could spur long-awaited bladder cancer treatment innovation]]> https://biospectrumindia.com/features/95/6084/roches-atezolizumab-could-spur-long-awaited-bladder-cancer-treatment-innovation.html https://biospectrumindia.com/features/95/6084/roches-atezolizumab-could-spur-long-awaited-bladder-cancer-treatment-innovation.html Thu, 30 Jul 2015 14:22:23 +0530 Roche's atezolizumab is poised to become a major bladder cancer therapy in the race for US Food & Drug Administration (FDA) approval, following its promising performance in recent Phase II trials, says an analyst with research and consulting firm GlobalData. In a potential bladder cancer breakthrough, Roche announced that atezolizumab, an anti-Programmed Death-Ligand 1 (PD-L1) therapy, met its primary endpoint of objective response rate in the Phase II IMvigor 210 study. During the trial, patients with higher PD-L1 expression levels showed better responses to the drug. According to Dr Cai Xuan, GlobalData's analyst covering oncology and hematology, this observation, along with similar results for other Programmed Cell Death Protein 1 (PD-1) inhibitors in development for various cancers, opens up a market for companion biomarker tests that can be used to identify patients who would likely benefit from PD-1/PD-L1-targeted therapies. Dr Xuan says: "Atezolizumab's Phase II results were preceded by an encouraging Phase Ia trial, during which the drug caused tumors to shrink in 50% of patients previously treated for PD-L1-positive, metastatic urothelial bladder cancer. "In this trial, 20% of patients made a full recovery, while 57% with the highest PD-L1 expression levels were still alive one year after treatment. The most frequently observed adverse events were fatigue, asthenia, and nausea, affecting 16%, 13% and 11% of patients, respectively." These three drugs have initially been targeted towards patients with locally-advanced and/or metastatic bladder cancer, with the possibility of expanding to multiple indications within the bladder cancer setting in the future. Dr Xuan continues: "With regards to future indications, Roche currently has a broader development program for atezolizumab in bladder cancer, with the IMvigor 211 Phase III trial evaluating the drug in comparison with standard-of-care chemotherapy in patients with relapsed urothelial bladder cancer. "Additionally, the IMvigor 010 Phase III trial will evaluate atezolizumab as an adjuvant therapy in early-stage, PD-L1-positive, muscle-invasive bladder cancer patients, who are at risk of recurrence. The potential to expand into multiple indications will make this drug an important player in a wave of long-awaited bladder cancer treatment innovation." ]]> <![CDATA[Dr Reddy's partners with Purdue University ]]> https://biospectrumindia.com/news/95/6083/dr-reddys-partners-with-purdue-university-.html https://biospectrumindia.com/news/95/6083/dr-reddys-partners-with-purdue-university-.html Thu, 30 Jul 2015 14:21:00 +0530 Purdue University has signed a strategic partnership memorandum of understanding (MoU) with Dr Reddy's Laboratories(DRL), to strengthen pharmaceutical research and development. The intent is to forge a strong strategic partnership in a range of research areas and novel technologies. Mr Suresh Garimella, Purdue University's executive vice-president for research and partnerships, and his counterpart Mr Amit Biswas, executive vice-president and global head of integrated product development, DRL, signed a memorandum of understanding, between the two organizations that will advance the Purdue Moves drug discovery initiative to translate basic research into life-changing treatments. Areas of planned collaborative research and education include targeted drug delivery, manufacturing technology, scale-up of pharmaceutical operations, process engineering, and research and development methodologies and technology. The collaboration will include student engagement and faculty exchanges and may include a site at Purdue Research Park. "Purdue has tremendous strength in pharmaceutical drug discovery and development research, but we need additional partners to help translate our discoveries through to the delivery of a medicine or technology. Dr Reddy's is a global pharmaceutical company that shares our mission to accelerate the rate at which new, advanced treatments make it to the millions of patients in need of relief. This partnership combines strengths that could lead to world-changing research," said Mr Garimella. "The long-term research partnership augurs well for DRL's philosophy of providing access to innovative, high-quality medicines to global patients at affordable cost," said Mr Biswas. He added, "Purdue University has talented researchers, unique instrumentation and an interdisciplinary approach to solving technology challenges that make them a perfect partner as we sharpen our focus on innovative drug development programs. We are thrilled to partner with Purdue. Together we can find innovative solutions to address unmet needs and improve the health of people all over the world." ]]> <![CDATA[BMS, Japan firm collaborate to develop new immunotherapies]]> https://biospectrumindia.com/news/95/6359/bms-japan-firm-collaborate-to-develop-new-immunotherapies.html https://biospectrumindia.com/news/95/6359/bms-japan-firm-collaborate-to-develop-new-immunotherapies.html Thu, 30 Jul 2015 14:15:00 +0530 Japan's Kyowa Hakko Kirin and Bristol-Myers Squibb have entered into a clinical trial collaboration agreement to conduct a Phase 1/2 combination study with mogamulizumab, an anti-CCR4 antibody and Opdivo (nivolumab), a PD-1 immune checkpoint inhibitor. The study, to be conducted in the US, will focus on evaluating the safety, tolerability and anti-tumor activity of combining mogamulizumab and Opdivo as a potential treatment option for patients with advanced or metastatic solid tumors. Prior to this agreement, Kyowa Hakko Kirin, Bristol-Myers Squibb and Ono Pharmaceutical entered into a clinical trial collaboration agreement to study the combination of mogamulizumab and Opdivo in Japan. Mogamulizumab and Opdivo are part of a new class of cancer treatments known as immunotherapies, which are designed to harness the body's own immune system in fighting cancer by targeting distinct regulatory components of the immune system. "We are pleased to conduct a combination study with Bristol-Myers Squibb not only in Japan but also in the US," said Yoichi Sato, director of the board managing executive officer, vice president, head of research and development division of Kyowa Hakko Kirin. "We believe that the planned combination of these two immunotherapies has the potential to deliver better outcomes in patients with advanced cancers than existing treatments." "Thes agreement builds on our initial collaboration with Kyowa Hakko Kirin in Japan, which includes our partner Ono Pharmaceutical and is the latest example of our continued commitment to evaluating the potential of combination immuno-oncology regimens for patients with metastatic cancer," stated Mr Michael Giordano, senior vice president, head of development, Oncology, Bristol-Myers Squibb. ]]> <![CDATA[Big Hit: Syngene's IPO subscribed 32 times ]]> https://biospectrumindia.com/news/95/5900/big-hit-syngenes-ipo-subscribed-32-times-.html https://biospectrumindia.com/news/95/5900/big-hit-syngenes-ipo-subscribed-32-times-.html Thu, 30 Jul 2015 12:39:00 +0530 Syngene's public offer opened for subscription on 27 July with a price band of Rs 240-250 per share. The company's IPO received bids for 51.28 crore shares (51,24,24,840) as against 1.6 crore (1,60,00,000) shares on offer, thus generating demand for shares worth over Rs 17,000 crore, according to the data available with the NSE. This is said to be the second-highest subscription to an IPO so far in 2015 after VRL Logistics which was subscribed 74 times. Syngene International is a wholly owned subsidiary of Biocon. ]]> <![CDATA[Industry veterans condole sudden death of Dr Kalam]]> https://biospectrumindia.com/news/95/4501/industry-veterans-condole-sudden-death-of-dr-kalam.html https://biospectrumindia.com/news/95/4501/industry-veterans-condole-sudden-death-of-dr-kalam.html Thu, 30 Jul 2015 10:58:13 +0530 As an eminent scientist and visionary, Dr Kalam was known for his commitment to encouraging indigenous technology and innovation. He always wanted to nurture young minds and fuel their curiosity for science. His passing away has therefore shocked the scientists and innovators accross industries. Bioscience industry too has been saddened by his passing away. Here are the few reactions: Dr BR Barwale, Chairman, Mahyco which recalling Dr Kalam's contribution mentioned, "We are deeply saddened by the news of the demise of Dr Kalam. He was an inspiration and a revolutionary. He always encouraged us to have a future using science and technology. Not many would know that Indian agriculture has also lost one of its fiercest proponents. His Vision 2020 document which in the words of the Prime Minister, acts as a Marg Darshak for a glorious Indian future, envisioned doubling India's agricultural productivity as its first focus area. We hope to make his dream of integrating science and agriculture a reality." Dr Kiran Mazumdar Shaw, CMD, Biocon took to Twitter to express her deep regards for Dr Kalam. "Shocked to learn about the sad demise of Dr Kalam. He inspired the entire nation. A great loss for India. Proud that I received my Padma Bhushan from President Kalam in 2005, a memory I will always treasure. Bharat Ratna APJ Kalam was a rare jewel who was the people's president loved by the young and the old. May he rest in peace." The Indian Society for Clinical Research (ISCR) expressed its deepest regrets at the passing away of former president. It stated: "We acknowledge Dr Kalam's immense contribution to science and healthcare. His mission to ignite a love for science is what ISCR is also committed to in our vision of "promoting a compelling scientific disposition and widespread awareness of clinical research for the advancement of healthcare." Dr Kalam's life and learnings will continue to be an inspiration to clinical research professionals and all members of ISCR as we work towards fostering an environment facilitating ethical and responsible clinical research for better patient outcomes while ensuring, as Dr Kalam once said, healthcare is "made affordable without compromising on quality." ]]> <![CDATA[India needs to broaden its Malaria tackling strategy: WHO]]> https://biospectrumindia.com/news/95/3950/india-needs-to-broaden-its-malaria-tackling-strategy-who.html https://biospectrumindia.com/news/95/3950/india-needs-to-broaden-its-malaria-tackling-strategy-who.html Thu, 30 Jul 2015 10:56:03 +0530 As nearly 3.2 billion people continue to live in areas with risk of malaria infection, malaria needs to be high on the global agenda to achieve the target of 90 percent reduction in deaths and disease, and elimination in 35 countries by 2030. This has been stated by the WHO. "Our efforts so far focused on the most deadly P. falciparum malaria. We need to now broaden our strategy to include targeted interventions for P. vivax malaria, which is contributing to a large proportion of global malaria burden, mainly in the WHO South-East Asia Region," Dr Poonam Khetrapal Singh, Regional Director, said at a global malaria meeting on July 29, 2015. Of the 18.9 million P. vivax malaria cases reported in 2012, nearly 13 million were from countries in the WHO South-East Asia Region, mainly India. "We need targeted strategies for P. vivax malaria which presents distinct challenges for control and elimination compared to P. falciparum. It is proving to be an extremely difficult parasite as it does not readily respond to the existing control measures and has the ability to remain hidden and beyond the reach of the currently available diagnostic tools and medication," Dr Khetrapal Singh said. P. vivax malaria is now the only remaining cause of malaria in countries that have eliminated P. falciparum malaria. More than a third of the world's population, mostly in Asia and Latin America, is at risk of P. vivax malaria. There is growing evidence that P. vivax malaria can cause severe disease and can also be fatal. WHO estimates that it could be responsible for up to 15% malaria deaths outside of Africa, as per the 'Technical Brief on Control and Elimination of P. vivax malaria,' launched at the meeting. The technical brief, developed with support from Medicines for Malaria Venture, provides information on, among others, the ways to address the challenges that are unique to P. vivax malaria. The revitalized efforts for malaria elimination should address technical challenges such as multidrug resistance, vector resistance to insecticides, outdoor transmission, and those related to relapsing of P. vivax malaria. Health systems issues such as inadequate health staff, poor delivery of health services and weak surveillance should be resolved. Since the determinants of malaria are mainly socio-economic, the focus should be beyond the health sector, and to strengthen cross-border collaboration for elimination of malaria and prevention of its re-emergence. Reducing the burden of malaria is part of Sustainable Development Goals 2030. In May 2015 the World Health Assembly adopted the Malaria Global Technical Strategy 2016 - 2030 which aims to reduce malaria deaths and disease by at least 90% and eliminate malaria in at least 35 countries by 2030. ]]> <![CDATA[Cipla grabs 51 percent stake in Uganda firm for $26 mn]]> https://biospectrumindia.com/news/95/7755/cipla-grabs-51-percent-stake-in-uganda-firm-for-26-mn.html https://biospectrumindia.com/news/95/7755/cipla-grabs-51-percent-stake-in-uganda-firm-for-26-mn.html Wed, 29 Jul 2015 12:58:00 +0530 Singapore: According to reports, Indian drug giant Cipla has renegotiated payment terms for acquiring majority stake in Uganda's Quality Chemicals. The company announced that it will obtain 51 percent stake for $26 million (around Rs 166 crore) upfront to the shareholders of the African firm. Cipla said in a statement, "Accordingly, the revised consideration is around $26 million ($25,995,730) payable upfront upon completion of conditions precedent." Earlier this year, Cipla had had inked a pact with Quality Chemicals Ltd (QCL) to acquire majority stake in it for a total consideration of over $30 million (around Rs 190 crore). QCL was incorporated in the year 1997 and is engaged in the business of import and distribution of pharmaceutical and consumer products. ]]> <![CDATA[MSD buys cCAM Biotherapeutics]]> https://biospectrumindia.com/news/95/7715/msd-buys-ccam-biotherapeutics.html https://biospectrumindia.com/news/95/7715/msd-buys-ccam-biotherapeutics.html Wed, 29 Jul 2015 12:57:00 +0530 With a view to further strengthen its immuno-oncology portfolio MSD has inked a definitive agreement to acquire Isreali drugmaker cCAM Biotherapeutics, a privately held biopharmaceutical company focused on the discovery and development of novel cancer immunotherapies. As per the terms, MSD, through a subsidiary, will acquire all outstanding stock of cCAM in exchange for an upfront payment of $95 million in cash. cCAM shareholders of record are eligible to receive a total of up to $510 million associated with the attainment of certain clinical development, regulatory and commercial milestones. The transaction is subject to certain closing conditions. The deal provides MSD with several early immunotherapy candidates including cCAM Biotherapeutics' lead pipeline candidate, CM-24 - a novel monoclonal antibody (mAb) targeting the immune checkpoint protein CEACAM1 that can treat advanced or recurrent malignancies, including melanoma, non-small-cell lung, bladder, gastric, colorectal, and ovarian cancers. Dr Roger M Perlmutter, president, MSD Research Laboratories, said, "We continue to strengthen our portfolio of immunotherapeutic candidates through strategic collaborations and acquisitions. The acquisition of cCAM supports our objective to advance the care of patients with cancer by stimulating tumor-directed immune responses." "MSD's excellence and leadership in immuno-oncology provides a strong foundation for advancing CM-24, for the treatment of people with cancer," said, Mr Pini Orbach, PhD, chairman of the Board, cCAM Biotherapeutics and head of Pharma at Arkin Holdings. "This is a significant achievement for cCAM Biotherapeutics, as well as a vote of confidence in the Israeli innovative biotech industry as a whole." ]]> <![CDATA[Eminent HIV researcher Dr Suniti Solomon passes away at 76]]> https://biospectrumindia.com/news/95/7919/eminent-hiv-researcher-dr-suniti-solomon-passes-away-at-76.html https://biospectrumindia.com/news/95/7919/eminent-hiv-researcher-dr-suniti-solomon-passes-away-at-76.html Wed, 29 Jul 2015 12:26:12 +0530 The medical fraternity, scientists and biologists are mourning over the sad demise of India's most respectable HIV researcher and the President of the AIDS Society of India, Dr. Suniti Solomon. Dr. Solomon, who was ailing from liver cancer, passed away at her residence in Chennai on Tuesday. She was 76 years old and was the first to bring to the world the prevalence of HIV infection in India in 1986. She was also the first one to successfully lead the research into the treatment of HIV infected individuals. "Her death was sudden, she passed away this morning. She was getting treatment for liver cancer for the past two months," Ganesh and Krishnan of Y R Gaitonde Center for AIDS Research and Education (YRG Care) told media. Dr. Suniti Solomon earned an M.D in Microbiology from Madras University. She was trained in pathology in the United Kingdom and the United States. She was the Founder-Director of the Y.R. Gaitonde Center for AIDS Research and Education (YRG CARE), a premier HIV/AIDS care and support centre in Chennai. She and her colleagues documented the first evidence of the HIV infection in India in 1986. When she served the Madras Medical College and Government General Hospital as a Professor of Microbiology, she set up the first voluntary testing and counseling centre and an AIDS Research Group in Chennai. Dr. Solomon was a member of the National Technical Team on women and AIDS, a member of the advisory board of International AIDS Vaccine Initiative-India, member of the Scientific Committee of the National AIDS Research Institute, Pune, Government of India, a permanent member on the Microbicides Committee of the Indian Council for Medical Research (ICMR), and was a member on the board of AVAHAN, the India HIV/AIDS Initiative of the Bill and Melinda Gates Foundation; Trustee At-Large of the International Association of Physicians in AIDS Care; and member of the Asia Data Safety Monitoring Board of the Division of AIDS, NIH, USA. Dr. Solomon was also the Indian Principal Investigator of several pioneering HIV research studies: the US National Institute of Mental Health's multi-country HIV/STD Prevention Trial; the US National Institute of Allergy and Infectious Diseases' HIV Prevention Trial Networks; NIH award that will measure stigma in health care settings in Southern India; and a Phase III study of 6% CS GEL, a candidate microbicide of CONRAD. She was the Director of the Southern India program of the Brown-Tufts Fogarty AIDS Training and Research Project. ]]> <![CDATA[Sanofi's Dengue vaccine development registers significant progress]]> https://biospectrumindia.com/news/95/7372/sanofis-dengue-vaccine-development-registers-significant-progress.html https://biospectrumindia.com/news/95/7372/sanofis-dengue-vaccine-development-registers-significant-progress.html Wed, 29 Jul 2015 12:19:44 +0530 Sanofi Pasteur, the vaccines division of Sanofi, announced on July 28, 2015 that new data analyses published in the New England Journal of Medicine (NEJM) provide a comprehensive picture of the potential public health impact of vaccinating endemic populations from pre-adolescence to adulthood against dengue. Not only is this the largest population at risk of dengue globally, but individuals 9 years of age and older also represent a highly mobile group capable of spreading disease more broadly during outbreaks and also contributing substantially to the economic burden of dengue, for example in number of lost school and work days due to the disease. The NEJM article reported results from a new pooled efficacy analysis of individuals 9 years of age and older at vaccination from the two Phase III studies of Sanofi Pasteur's dengue vaccine. The new analysis documented that the vaccine protects two-thirds of these individuals (66%) against dengue, providing even greater protection against two clinically-relevant manifestations of dengue, namely severe dengue (93%) and prevention of hospitalizations due to dengue (80 percent) that account for the greatest human and economic burden of dengue in endemic countries. In addition, the dengue vaccine candidate protected volunteers 9 years of age and older who were previously exposed to dengue (82 percent), as well as those who were naÃ¯ve to dengue (52.5 percent) prior to vaccination. The clinical development program for the vaccine candidate includes studies with four-year, long-term follow-up phases, in line with WHO guidelines for dengue vaccine development. Results from first 25 months of the two Phase III efficacy studies were published in 2014.4,5 Interim data from the third year of these studies and interim data from the third and fourth years of the Phase II extension study in Thailand published in the new NEJM article confirm the continuing reduction of hospitalized dengue in the vaccinated population 9 years of age and older. The third-year interim data from the Asian Phase III study identified the need for further long-term surveillance in children under 9 years of age to assess the impact of the dengue vaccine candidate in these younger children. "It is not unusual to require additional data on a new vaccine to determine its value in a specific age group, particularly young children, whose immune response to the vaccine and the disease may differ significantly from that of older children and adults," notes Professor Tim Endy, MD., MPH, Upstate University Hospital, New York. "It is reassuring to have confirmation of the safe protection that this vaccine offers against dengue in the endemic preadolescent to adult population, particularly coupled with its consistent efficacy and safety profile reported last year from the PIII studies across diverse geographic regions, ethnic study populations and dengue epidemiology covered." Dr Maria Rosario Capeding from the Research Institute for Tropical Medicine in the Philippines, who is a lead author on the NEJM article, points out the potential public health benefit of having a first dengue vaccine available to protect individuals 9 years of age and older. "This large, at-risk population includes the most dynamic members of the community who have the potential to spread disease widely and also contribute most to dengue's heavy societal impact in terms of school absences and lost work productivity. Certainly, individuals 9 years of age and older represent a compelling target group for an immunization program against dengue aimed at significantly reducing overall disease burden." Dengue is the world's fastest growing vector-borne disease, endemic in over 100 countries where almost half the world's population resides. Dengue poses considerable economic and human burden in these endemic countries as it is prone to unpredictable outbreaks and spreads readily in densely populated urban areas, often paralyzing local healthcare systems and requiring cost-intensive intervention efforts. Today, no specific treatment or prevention for dengue is available. The WHO has set objectives to reduce mortality due to dengue by 50% and morbidity by 25 percent by 2020. Introduction of an effective and safe dengue vaccine as an integral part of dengue prevention efforts will be critical to achieving this goal. Based on the totality of the safety and efficacy data for its dengue vaccine candidate, Sanofi Pasteur has decided to recommend a targeted age indication for the vaccine of 9 years of age and older in endemic countries, where the combination of disease burden and the vaccine's proven impact profile in this age group point to the greatest potential for reduction of dengue disease burden in these countries. ]]> <![CDATA[Chennai gears up for India's largest B2B Medical Exposition]]> https://biospectrumindia.com/news/95/7383/chennai-gears-up-for-indias-largest-b2b-medical-exposition.html https://biospectrumindia.com/news/95/7383/chennai-gears-up-for-indias-largest-b2b-medical-exposition.html Wed, 29 Jul 2015 12:18:30 +0530 The 13th edition of Medicall is all set to be held in Chennai for three days beginning from July 31st to August 2nd, 2015. Medicall serves as a marketing platform wherein the medical equipment manufacturers will showcase their products to hospital owners and other key decision makers in the medical fraternity. In its 13th edition, Medicall 2015 is said to be an international show with over 750 exhibitors from more than 20 countries and the event is expected to have more than 20,000 professional visitors. This year, the event also features 'The Innovation Awards', which will honour worthy winners in Medical Equipment, Clinical and Surgical Practices, CSR initiatives in Healthcare and Apps, Social Media & ICT in Healthcare. Speaking about the event, Dr. S Manivannan, Founder and Director of Kauvery Hospitals, Chennai, and promoter of Medicall event, said, "Early in my career, I identified that nursing homes, small clinics and hospitals in tier 2 and 3 cities faced a distinct disadvantage in the market while procuring consumables and equipment for their business. They neither had the choice nor the price advantage that was enjoyed by the biggies. Thus Medicall was born. This event will be a perfect getaway to meet one's peers; to compare and choose equipment; and best of all to refresh the knowledge base in the intellectually stimulating BrainStorm Medicall session. We hope that this year too, the seminars and workshops will be a value add for the participants." He further added, "Medicall 2014 had witnessed participation from approximately 630 exhibitors from across the globe. Most of the exhibitors substantially increased the size of their stall and showcased more products during the 3-day exhibition. It was a true bazaar for hospital equipment and supplies, ranging from surgical gloves to the most sophisticated medical equipment used worldwide." The organizers of Medicall 2015 have put together seminars on topics that feature: Costing for Hospitals; Workshop on NABH Pre-Accreditation entry level for Hospitals; Succession planning; Lean Six Sigma; HR in Hospitals; IT: Workshop in Social Media, SEO and Mobile Apps for Healthcare. ]]> <![CDATA[World's first portable molecular diagnostic system unveiled ]]> https://biospectrumindia.com/news/95/7382/worlds-first-portable-molecular-diagnostic-system-unveiled-.html https://biospectrumindia.com/news/95/7382/worlds-first-portable-molecular-diagnostic-system-unveiled-.html Wed, 29 Jul 2015 11:56:50 +0530 California's Cepheid unveiled the GeneXpert Omni, a flexible and portable clinical molecular diagnostic system designed to meet the needs of the Point-of-Care market. The company explained that at just 9 inches tall, and weighing just 2.2 pounds, the GeneXpert Omni will run the same high quality PCR-based Xpert cartridges as Cepheid's existing family of GeneXpert Systems, enabling highly accurate clinical molecular diagnostic tests to be performed in any near-patient testing environment, including CLIA-waived physician offices, clinics and specialty settings. "Building on the accuracy, speed and ease-of-use that users expect from Cepheid's GeneXpert Systems, the GeneXpert Omni offers an even more streamlined user experience, with an advanced user interface that runs on a portable tablet or smartphone," said John Bishop, Cepheid's Chairman and Chief Executive Officer. "The GeneXpert Omni is also wireless and web-enabled, setting a new standard in connectivity to transmit instrument and test information in real-time, supporting our customers' goals to cost-effectively improve clinical outcomes and increase patient satisfaction." "Recognizing the need for faster test results in the Point-of-Care environment, Cepheid expects to launch even faster Xpert tests in conjunction with the availability of the GeneXpert Omni," said David Persing, Cepheid's Chief Medical and Technology Officer. "Compared to an average run-time of about an hour today, we are further optimizing every stage within the cartridge with a goal of delivering test results in as little as 15 minutes, starting with our Xpert Xpress Group A Strep assay." The GeneXpert Omni is on display at the American Association of Clinical Chemistry (AACC) meeting in Atlanta, Georgia, USA, from July 28th to 30th , 2015. The system is expected to be available for commercial Point of Care customers in late 2016. The first test for the GeneXpert Omni is expected to be Xpert Flu/RSV. ]]> <![CDATA[FDA approves Novartis' skin cancer drug ]]> https://biospectrumindia.com/news/95/7381/fda-approves-novartis-skin-cancer-drug-.html https://biospectrumindia.com/news/95/7381/fda-approves-novartis-skin-cancer-drug-.html Wed, 29 Jul 2015 11:39:00 +0530 Novartis has announced that the US Food and Drug Administration (US FDA) has approved Odomzo (sonidegib, formerly LDE225) 200 mg capsules, for the treatment of adult patients with locally advanced basal cell carcinoma (laBCC), that has recurred following surgery or radiation therapy, or those who are not candidates for surgery or radiation therapy. "The FDA approval of Odomzo offers a new and non-invasive treatment option for a potentially devastating disease that is hard to treat and can be disfiguring," said Mr Bruno Strigini, president, Novartis Oncology. He added, "Odomzo is an important addition to our growing portfolio of targeted treatments for advanced skin cancers and underscores our commitment to developing and bringing to market new options for patients." The Odomzo approval was based on the demonstration of a durable objective response rate (ORR) in an international, multi-center, double-blind, randomized, two-arm, non-comparative trial in patients with laBCC not amenable to local therapy or metastatic basal cell carcinoma (mBCC). Patients with laBCC treated with Odomzo 200 mg (n=66) were followed for at least 12 months unless discontinued earlier. The ORR was 58 percent(95 percent confidence interval: 45, 70), consisting of 5 percent (n=3) complete responses (CR) and 53 percent (n=35) partial responses (PR). A pre-specified sensitivity analysis using an alternative definition for CR, defined as at least a PR according to MRI and/or photography and no evidence of tumor on biopsy of residual lesion, yielded a CR rate of 20 percent. Among the 38 patients with an objective response, 31 patients (82 percent) have ongoing responses ranging from at least 1.9 to 18.6 months and the median duration of response has not been reached. The most serious risks of Odomzo are embryofetal toxicity and musculoskeletal adverse reactions including rhabdomyolysis. Musculoskeletal adverse reactions, which may be accompanied by serum creatine kinase (CK) elevations, may occur with Odomzo and other drugs which inhibit the hedgehog pathway. The incidence of musculoskeletal adverse reactions in patients with laBCC treated with Odomzo 200 mg was 68 percent, with 9 percent reported as grade 3 or 4. ]]> <![CDATA[Sanofi inks Immuno-Oncology pact with Regeneron ]]> https://biospectrumindia.com/news/95/7362/sanofi-inks-immuno-oncology-pact-with-regeneron-.html https://biospectrumindia.com/news/95/7362/sanofi-inks-immuno-oncology-pact-with-regeneron-.html Wed, 29 Jul 2015 11:19:00 +0530 Sanofi and Regeneron Pharmaceuticals have entered into a new global collaboration to discover, develop and commercialize new antibody cancer treatments in the emerging field of immuno-oncology. As part of the agreement, the two companies will jointly develop a programmed cell death protein 1 (PD-1) inhibitor currently in Phase I testing, and plan to initiate clinical trials in 2016 with new therapeutic candidates based on ongoing, innovative preclinical programs. "The field of immuno-oncology has shown the potential to dramatically improve outcomes for patients with certain types of cancer - however, the field is still in its very early days," said Dr George D Yancopoulos, chief scientific officer, Regeneron and president, Regeneron Laboratories. He added, "We believe the approaches most likely to deliver the best results to patients will combine multiple innovative therapies acting on different pathways and targets both in the tumor and the body's immune response - and precisely target these medicines to the right patient. The efficiency and power of our suite of technologies, such as VelocImmune and VelociGene, combined with our human genetics capabilities, uniquely positions the Alliance to accelerate the development of potential new immuno-oncology treatment options for cancer patients." Sanofi will make an upfront payment to Regeneron of $640 million and the companies will invest $1 billion for discovery through proof of concept (POC) development (usually a Phase IIa study) of monotherapy and novel combinations of immuno-oncology antibody candidates to be funded 25 percent by Regeneron ($250 million) and 75 percent by Sanofi ($750 million). The companies have also committed to equally fund an additional $650 million (or $325 million per company) for development of REGN2810, a PD-1 inhibitor. In addition, Sanofi will pay to Regeneron a one-time milestone of $375 million in the event that sales of a PD-1 product and any other collaboration antibody sold for use in combination with a PD-1 product exceed, in the aggregate, $2 billion in any consecutive 12-month period. Finally, the two companies have agreed to re-allocate $75 million (over three years) for immuno-oncology antibodies from Sanofi's $160 million annual contribution to their existing antibody collaboration, which otherwise continues as announced in November 2009. Beyond the committed funding, additional funding will be allocated as programs enter post-POC development. "The Sanofi-Regeneron Alliance has demonstrated its ability to translate cutting-edge science into groundbreaking medicines for patients with serious needs. With more than eight years of successful collaboration between us, I am confident in our ability to advance these novel programs. In addition to PD-1, the collaboration brings together a range of validated, innovative preclinical programs that have unique potential to help patients either as monotherapy or in combination approaches," said Dr Elias Zerhouni, president, Global R&D, Sanofi. The new agreement covers both monoclonal antibodies and new bi-specific antibodies, a variation of standard antibody therapeutics, in which two distinct targets within the body can be bound by the same molecule, usually the cancer cell and an immune cell. Regeneron has developed a novel and flexible manufacturing platform that enables efficient production of bi-specific antibodies that are otherwise similar to natural antibodies. ]]> <![CDATA[ILBS Delhi organizes discussion on silent epidemic 'Hepatitis']]> https://biospectrumindia.com/news/95/7266/ilbs-delhi-organizes-discussion-on-silent-epidemic-hepatitis.html https://biospectrumindia.com/news/95/7266/ilbs-delhi-organizes-discussion-on-silent-epidemic-hepatitis.html Tue, 28 Jul 2015 14:47:07 +0530 July 28th every year has been designated as World Hepatitis Day by World health Organization to focus global attention on the looming Hepatitis Epidemic. A day before on July 27, 2015, the National Liver Foundation and its partners held a discussion and media round-table on Viral Hepatitis B and C in India at New Delhi. Dr Shiv Sarin, director, Institute of Liver and Biliary Sciences, New Delhi opened the discussion "Addressing Viral Hepatitis - A Challenge for India, Much needs to be done to address this silent epidemic."with a reminder that Hepatitis B & C infections are easily transmitted, particularly in health care settings, but with vaccines for Hepatitis B and treatment for Hepatitis C now available, the opportunity was ripe to take bold steps to control the problem of Hepatitis. He added: "We today have a very effective vaccine to prevent Hepatitis B. Every child should be protected at birth with this vaccine. Similarly, infection control and safe injection practices will ensure that no more transmission on Hepatitis B or C takes place in health care settings. For those with Hepatitis C, new drugs today bring hope for complete cure. We need to make sure that treatment is made accessible to all those who need it." Ms Bhavna Visharia, a social activist from Mumbai, was a regular blood donor and organizer of blood donation camps. When it was found during her 17th donation that she had Hepatitis C, her situation changed dramatically. Today, she is healthy. She said: "The system of blood donation can save lives; it should be kept that way. We should ensure that life saving processes like blood donation and getting injections do not create a larger problem like Hepatitis for individuals and the society." Speaking in conclusion, Dr Samir Shah, Founder and Hon. General Secretary of National Liver Foundation called attention to the growing numbers of people contracting Hepatitis B & C infections in India: "We need to get a handle on the Hepatitis Epidemic in India. A concerted national Hepatitis Control program needs to be launched at the earliest possible. We call on all state governments and our national leadership to take urgent actions." ]]> <![CDATA[World Hepatitis Day: WHO calls for equitable services in diagnosis & treatment]]> https://biospectrumindia.com/news/95/6474/world-hepatitis-day-who-calls-for-equitable-services-in-diagnosis-treatment.html https://biospectrumindia.com/news/95/6474/world-hepatitis-day-who-calls-for-equitable-services-in-diagnosis-treatment.html Tue, 28 Jul 2015 14:46:37 +0530 Globally, Viral hepatitis kills 4 000 people every day. Each year an estimated 1.5 million people die due to hepatitis, which includes deaths by liver cancer and cirrhosis. Nearly one third of the global hepatitis deaths - 500 000 - occur in the WHO South-East Asia Region (SEAR). The situation is alarming within the region with around 100 million people living with chronic hepatitis B infection and another 30 million with chronic hepatitis C. India alone has 40 million people living with chronic hepatitis B infection. 60 percent of people living with HIV are co-infected with hepatitis with increased the risk of complications and deaths. In her statement to media, Dr Poonam Khetrapal Singh, Regional Director, World Health Organisation South-East Asia Region mentioned, "Each one of these numbers carry a potential story of suffering, pain, lost livelihoods, missed opportunities, social, psychological and economic costs. These infections, disease, deaths and associated hardships for individuals, families, societies and economies can and must be prevented." "Governments need to ensure adequate and equitable access to hepatitis prevention and control measures. However, the responsibility also lies with individuals. Nearly 65 percent of people living with chronic hepatitis B and 75 percent of those with chronic hepatitis C are unaware that they are infected. We are living with this risk and unless we act now, it can be catastrophic," added Dr Khetrapal. She also mentioned that health promotion initiatives need to be strengthened and people made aware of the how they risk getting hepatitis and what they need to do protect themselves and their families from the hepatitis viruses. There is need for awareness among health administrators, policymakers, and medical professionals. The health sector needs to strengthen disease surveillance systems, ensure injection and patient safety, reliably and systematically screen all blood products, ensure strict adherence to the new WHO injection safety guidelines and improve infant vaccination rates including birth dose of hepatitis B within first 24 hours of delivery. WHO is supporting countries to adopt data-driven and evidence-based policies to prevent, screen and treat hepatitis infections. Nearly 40% of those infected with hepatitis B and 80 percent of those with hepatitis C require life-long medical treatment, making access to affordable prevention and treatment for viral hepatitis an absolute necessity. WHO India head concluded by saying that this year's theme for World Hepatitis Day on July 28 is "Prevent hepatitis. Act now." The global focus this year will be on preventing hepatitis B and C. With effective vaccine and treatment, as well as a better understanding of how we can prevent hepatitis, we can aim to eliminate these diseases and save lives." ]]> <![CDATA[Indian & East African experts to discuss joint strategy on AIDS vaccine ]]> https://biospectrumindia.com/news/95/6811/indian-east-african-experts-to-discuss-joint-strategy-on-aids-vaccine-.html https://biospectrumindia.com/news/95/6811/indian-east-african-experts-to-discuss-joint-strategy-on-aids-vaccine-.html Tue, 28 Jul 2015 14:45:59 +0530 A high level Technical Consultation organised on 28th July, 2015 in New Delhi saw the participation of Indian and East African experts from leading institutes/centres of excellence. In addition to facilitating acceleration of new preventive technologies, such initiatives would help to ensure greater role for Low- and Middle-Income economies in AIDS vaccine research. This and the proposed collaboration between India and Netherlands in HIV research, announced during the Dutch Prime Minsters visit to India, would value add to effort of the Government of India through technology and knowledge transfer. DBT and ICMR are in the process of structuring a national program being for Chronic and Acute infection HIV cohorts, setting up of a National Biorepository and initiating studies towards HIV Virology and Host-Microbe interaction. "These multiple interlinked efforts contribute to Government of India's mandate of eradicating diseases through effective preventive measures, convert India into a knowledge society as well provide accessible, affordable, accountable, and effective primary healthcare facilities, are bringing the two Ministries of Health and Family Welfare and Ministry of Science & Technology together," mentioned Dr Rajat Goyal, Country Director - International AIDS Vaccine Initiative. HIV remains one of the most challenging viral diseases worldwide and for India- despite substantial progress in reducing new incidence of HIV, the country still houses with the third-highest number of people of people living with the disease at 2.1 million. To reach zero HIV burden in the country it is critical to fill gaps in the knowledge of how humans can defeat the virus as well reenergize and revolutionalize research efforts through relevant partnerships to understand factors responsible for prevention and control of HIV infection and to develop strategies that support and accelerate discovery efforts. In addressing diseases of concern for improved public health, HIV research is an emerging program priority for India with a goal to help identify tools and methods for disease detection, intervention, control, prevention and subsequent eradication. The Government of India has taken several initiatives over the years to reinforce the national response to the global fight against HIV/AIDS through the MoHFW and the MoST departments. Continued and ongoing efforts in HIV research to understand the interaction between humans and disease are critical to not only boost efforts for biomedical tools of prevention like HIV vaccine but also accelerate R&D initiatives for finding solutions to help curb the disease in India. ]]> <![CDATA[Confirmed: Teva to acquire Allergan generics for $40.5 billion]]> https://biospectrumindia.com/news/95/7244/confirmed-teva-to-acquire-allergan-generics-for-40-5-billion.html https://biospectrumindia.com/news/95/7244/confirmed-teva-to-acquire-allergan-generics-for-40-5-billion.html Tue, 28 Jul 2015 12:10:00 +0530 Teva Pharmaceutical has announced that it has signed a definitive agreement with Allergan to acquire Allergan Generics in a transaction valued at $40.5 billion. Upon closing, Allergan will receive $33.75 billion in cash and shares of Teva valued at $6.75 billion, representing an estimated under 10 percent ownership stake in Teva. Teva believes the acquisition will be significantly accretive to non-GAAP EPS, including expected double-digit non-GAAP EPS accretion in 2016 and more than 20 percent accretion in year two and year three following the close of the transaction. The transaction was unanimously approved by the Boards of Directors of Teva and Allergan, and is expected to close in the first quarter of 2016. "This transaction delivers on Teva's strategic objectives in both generics and specialty," said Mr Erez Vigodman, president and CEO of Teva. He added, "Through our acquisition of Allergan Generics, we will establish a strong foundation for long-term, sustainable growth, anchored by leading generics capabilities and a world-class late-stage pipeline that will accelerate our ability to build an exceptional portfolio of products, both in generics and specialty as well as the intersection of the two. Our respective portfolios of generic medicines and applications are highly complementary, providing Teva with high quality growth and earnings visibility, and the scale and resources to expand upon our specialty capabilities." Prof. Yitzhak Peterburg, chairman of the Teva Board of Directors, said, "This acquisition will result in significant and sustained value creation for our stockholders, reinforces our strategy, accelerates the fulfillment of a new business model, strongly supports top-line growth and opens a new set of possibilities for Teva. Together with Allergan Generics, Teva will have a much stronger, more efficient platform to achieve our goals, both financially and strategically, with the right platform for future organic and inorganic growth." ]]> <![CDATA[FDA nod for Esmolol Hydrochloride Injection]]> https://biospectrumindia.com/news/95/7246/fda-nod-for-esmolol-hydrochloride-injection.html https://biospectrumindia.com/news/95/7246/fda-nod-for-esmolol-hydrochloride-injection.html Tue, 28 Jul 2015 12:08:02 +0530 Aurobindo Pharma has announced that the company has received final approvals from the US Food and Drug Administration (USFDA) to manufacture and market Esmolol Hydrochloride Injection, 100mg/10mL (10mg/mL), (ANDA 205520). Esmolol Hydrochloride Injection, 100mg/10mL (10mg/mL) is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) Brevibloc Injection, 10mg/mL of Baxter Healthcare Corporation. Esmolol Hydrochloride Injection is indicated for the short-term treatment of tachycardia and hypertension that occur during induction and tracheal intubation, during surgery,on emergence from anesthesia and in the postoperative period. Aurobindo now has 13 ANDAs (represented by 10 product classes) approved out of Unit IV formulation facility in Hyderabad for manufacturing general injectable products. ]]> <![CDATA[Former President Dr. APJ Abdul Kalam passes away]]> https://biospectrumindia.com/news/95/7243/former-president-dr-apj-abdul-kalam-passes-away.html https://biospectrumindia.com/news/95/7243/former-president-dr-apj-abdul-kalam-passes-away.html Tue, 28 Jul 2015 09:48:00 +0530 New Delhi: India's 11th President Avul Pakir Jainulabdeen Abdul Kalam died on Monday evening at a hospital in Meghalaya, where he had gone to deliver a lecture. He was 83. The former President, who was in office from 2002 to 2007, had collapsed during the lecture at the Indian Institute of Management, Shillong, around 6.30 pm. He was taken to the Bethany hospital. Doctors said he had suffered a massive cardiac arrest. A career scientist turned reluctant politician, Kalam was born and raised in Rameswaram, Tamil Nadu and studied physics and aerospace engineering. He spent the next four decades as a scientist and science administrator, mainly at the Defence Research and Development Organisation (DRDO) and Indian Space Research Organisation (ISRO) and was intimately involved in India's civilian space program and military missile development efforts. He thus came to be known as the Missile Man of India for his work on the development of ballistic missile and launch vehicle technology. Kalam was elected President of India in 2002 with the support of both the ruling Bharatiya Janata Party and the opposition Indian National Congress. After serving a term of five years, he returned to his civilian life of education, writing and public service. He received several prestigious awards, including the Bharat Ratna, India's highest civilian honour. Dr Kalam was born in Rameswaram on October 15, 1931, to a humble family. His father was a boatman. A bright student, his interest in flying led to a degree in aeronautical engineering, and eventually to supervising the development of India's guided missile programme. This was Dr. Kalam's last tweet. ]]> <![CDATA[CSIR research on medicinal properties of Cow urine]]> https://biospectrumindia.com/news/95/4117/csir-research-on-medicinal-properties-of-cow-urine.html https://biospectrumindia.com/news/95/4117/csir-research-on-medicinal-properties-of-cow-urine.html Mon, 27 Jul 2015 14:00:38 +0530 New Delhi: Council of Scientific and Industrial Research (CSIR) through its constituent laboratories has conducted research studies in collaboration with Go Vigyan Anusandhan Kendra, Nagpur on cow urine distillate for its antioxidant and bio-enhancing properties on anti- infective and anti-cancer agents and nutrients. Four US Patents have been secured since 2002 and one pharmaceutical product containing cow urine distillate with anti-oxidant property is available in the market. "Panchagavya is a classic collective name of five products obtained from cow viz milk, curd, ghee, urine and dung. Cow urine is ingredient of several Ayurvedic formulations and also used as adjuvant with medicinal formulations and for pharmaceutical processing called Shodhana (Purification) and Bhavana (Triturition) of medicinal materials," stated the Minister of State (Independent Charge) for AYUSH, Mr Shripad Yasso Naik in reply to an unstarred question in the Parliament on July 24, 2015. Earlier in 2014, Central Council for Research in Ayurvedic Sciences conducted a National Seminar on Panchagavya Chikitsa for promotion and awareness building and brought out a compilation document of published research papers on Panchagvya and its ingredients. The published research papers on Panchagavya have been uploaded in the 'AYUSH Research Portal' for ready access to the public. Panchagavya and its ingredients are part of the course curricula of Ayurvedic studies at degree and post-graduation levels. Opportunities of postgraduate and postdoctoral research as well as extramural research on Panchagavya are available to the interested scholars and scientists. ]]> <![CDATA[Indian embyonic stem cell technology gets patent in Malaysia]]> https://biospectrumindia.com/news/95/7308/indian-embyonic-stem-cell-technology-gets-patent-in-malaysia.html https://biospectrumindia.com/news/95/7308/indian-embyonic-stem-cell-technology-gets-patent-in-malaysia.html Mon, 27 Jul 2015 13:56:42 +0530 The Human Embryonic Stem Cell technology developed by Dr Geeta Shroff at Nutech Mediworld has been granted the 66th patent in Malaysia for the treatment of various medical conditions. Dr Shroff's technology is being used for treatments of many incurable diseases ranging from Spinal cord injury, Diabetes, ALS, Cerebral palsy, Stroke, Parkinson's disease and others. She developed the technology to isolate human embryonic stem cells, culture them, prepare them for clinical application, and store them in ready-to-use form. The technology differentiates itself from other stem cell therapies in three major ways. Firstly, it has universal application, i.e. anyone and everyone can take these cells without the need for matching. Secondly, it is available in a ready to use form with a shelf life of 6 months & can be transported easily. Thus is not clinic based. Thirdly, it has an easy non-invasive delivery mechanism and can be administered in the simple form of an injection. Due to these qualities it has the potential to be made readily available in pharmacies across the world, much like insulin. According to Dr Geeta Shroff, Founder and Medical Director of Nutech Mediworld, "This new patent establishes India as a leader in stem cell therapy as now we have developed a ready-to-use product with a shelf life of six months. Due to the enormous health benefits to the population, it is important to make this therapy available globally, as a first line of treatment, to safely and effectively improve the quality of life of patients suffering from conditions presently labeled incurable or terminal." Over the last 13 years, Nutech Mediworld has treated over 1300 patients from 51countries. Conditions treated include spinal injuries, multiple sclerosis, Parkinson's disease, diabetes, Lyme disease, cerebral palsy and autism. A number of peer-reviewed papers related to this technology have already been published in international scientific & medical journals. Early this year, Dr Shroff's technology was formally granted its 65th patent in Israel. The technology has already been granted patents in countries like Japan, Singapore, South Korea, USA, Australia, New Zealand. The team has an additional 82 patents in different countries at varying stages of evaluation. Dr Shroff began research on human embryonic stem cells in 1999 and is a global pioneer in human embryonic stem cell therapy. She is the first person to develop purely human embryonic stem cell lines using just a single, spare, pre-implantation stage fertilized egg from a regular IVF cycle. This was done in 2000 with the patient's consent, in full compliance with the regulatory guidelines. The same original embryonic stem cell line is still being used, without repeated need for fertilized eggs. As per Dr Shroff, "Stem Cell drug research and development is particularly burdensome for scientists in developing countries, where resources are limited and the filing and maintenance of patents are very expensive." ]]> <![CDATA[J&J to challenge Novartis in axSpA treatment space]]> https://biospectrumindia.com/news/95/7188/jj-to-challenge-novartis-in-axspa-treatment-space.html https://biospectrumindia.com/news/95/7188/jj-to-challenge-novartis-in-axspa-treatment-space.html Mon, 27 Jul 2015 13:54:14 +0530 Johnson & Johnson's (J&J) psoriasis drug, Stelara, has progressed into Phase III development for axial spondyloarthritis (axSpA) and, following its anticipated approval, is forecast to achieve impressive axSpA sales of $244.7 million in 2024, says research and consulting firm GlobalData. The company's latest report states that Stelara, an IL12/IL23 inhibitor, has demonstrated a strong safety profile in other indications, and is expected to launch in the US and five European countries (France, Germany, Italy, Spain, and the UK) for the treatment of ankylosing spondylitis (AS) in H2 2020 and non-radiographic axial spondyloarthritis (nr-axSpA) in H1 2021. According to Dr Heather Leach, GlobalData's senior analyst covering immunology, the anticipated launches of Novartis' Cosentyx, an IL17 inhibitor, and J&J's Stelara will add new mechanisms of action (MoAs) to the existing axSpA treatment space. The drugs will also command premium pricing, above that of the most frequently used anti-tumor necrosis factor (anti-TNF) biologics, helping to boost the global market value to US $2.9 billion by 2024. Dr Leach says: "Stelara will compete most heavily with Novartis' Cosentyx in treating patients who have failed at least one anti-TNF biologic or are intolerant to the therapy." Key opinion leaders interviewed by the firm expressed a preference for Cosentyx as a first-line therapy, if reimbursed, or following the first anti-TNF failure. "However, Stelara is also in Phase III development for ulcerative colitis and Crohn's disease, making it likely to be the preferred treatment option for patients with inflammatory bowel disease, a comorbidity frequently seen in axSpA," Dr Leach comments. The analyst adds that while Cosentyx and Stelara will partially address the unmet need for therapies with novel MoAs, opportunities will remain for drug developers in this previously overlooked market. Dr Leach explains: "There are currently a limited number of drug classes in the AS therapy market, with Cosentyx bringing only the second MoA for use after non-steroidal anti-inflammatory (NSAID) drug failure. There are additional opportunities for companies to expand into nr-axSpA treatment, for which there are no approved biologics in the US. "While Novartis' Cosentyx and Celgene's Otezla will have some limited off-label use in nr-axSpA, an approval will enable more widespread use. J&J released its plans in March 2015 to conduct trials for Stelara in both AS and nr-axSpA patients, and other companies are expected to follow this trend towards conducting trials earlier for nr-axSpA." ]]> <![CDATA[Experts discuss nutraceuticals market & its regulatory framework]]> https://biospectrumindia.com/news/95/7184/experts-discuss-nutraceuticals-market-its-regulatory-framework.html https://biospectrumindia.com/news/95/7184/experts-discuss-nutraceuticals-market-its-regulatory-framework.html Mon, 27 Jul 2015 13:12:59 +0530 The 'National symposium on Nutraceuticals, Herbals and Functional Foods' was organized by the knowledge chamber, The Associated Chambers of Commerce and Industry of India (ASSOCHAM) on July 22, 2015 at New Delhi. Speaking on the occasion, the health minister in Delhi government, Mr Satyendra Jain mentioned that the state government would be opening a thousand clinics in a year mostly in slums where the emphasis will be in protecting health and improving immunity through better nutrition and health supplements. He recalled that in the three clinics the Delhi government opened recently in the slums, majority of patients was women. Out of them 80 per cent were found suffering from high deficiency in hemoglobin. The ASSOCHAM-RINCOS knowledge paper on nutraceuticals, herbals and functional foods was also released at the seminar. The event was attended by close to 300 participants including academicians, industry leaders, students and activists. Besides various sessions that saw presentations and discussions, there were question answer sessions between participants and panellists. "The market is restrained by lack of a solid regulatory framework which is crucial for medical credibility as it ensures high quality products. The paper revealed that the US alone has 36 per cent of the global market for these with Asia-pacific rising to 30 per cent. Japan is a major consumer with 14 per cent and China 10 per cent," mentioned Mr D S Rawat, secretary general, ASSOCHAM. Taking on this theme, Dr H K Chopra, chief cardiologist at Moolchand Medicity and co-chairman of ASSOCHAM national Council of Healthcare and Hospital , emphasized that healthcare was more important than medicare. "In public health programmes, the emphasis should shift from illness to wellness. This would save millions of people from later diseases. Over 90 per cent of people above 60 years of age suffered from nutritional deficiency. It was very important that more than pharmaceuticals the people needed nutraceuticals (nutritional supplements)," he said. The symposium revealed huge market that was opening up in the country for nutritional materials and herbals. Dr B K Rao, chairman, ASSOCHAM National Council of Healthcare and Hospital and former chairman of Sir Ganga Ram Hospital revealed that the nutraceuticals and herbals market in India would be 4 billion USD by 2018 with a compound growth rate of 18 per cent. He regretted the lack of clarity in regulatory structure in this sector with lot of claims, counter-claims and myths cluttering the prospects. Among others who spoke at the symposium Mr P K Jain, chairman of ASSOCHAM MSME Council said, Andhra, Tamil Nadu and West Bengal were emerging as the main centres of production of nutraceuticals and herbals production. All big pharmaceutical companies were now moving into production of these. Detailing the holistic treatment needed for better health through nutraceuticals, Mr Shishmul Maheshwari, founder and CEO of RNCOS stressed the preventive quality of these materials. The huge change in healthcare that probiotic materials brought about in Japan, Mr Minoru Shimada, MD of Yakult Danone India recalled the history of this growth. During the first plenary session, the panel discussed R&D innovations in nutraceuticals and Indian regulatory norms in sync with global standards. Moderated by Mr Shushmul Maheshwari, founder and CEO, RNCOS, the discussion was on various aspects pertaining to current scenario. Mr Arun Kelkar, managing director, Hexagon Nutrition India gave a talk on effective introduction of herbals in functional foods. Ms Vani Bhambri Arora, deputy director, Quality Council of India gave insights on enhancing product acceptability through accredited third party conformity assessment system. "Innovations in nutraceuticals and functional foods-contribution from the R&D," was the topic of talk given by Mr V Hariharan, CEO and MD, Phytotech Extracts. He mentioned about the guidelines for nutraceuticals prepared by World Health Organization (WHO). He elaborated, "Selecting right dosage forms is very important. Deeper in-vitro and in-vivo studies are required." Nutragenomics addresses the role in genes. Development of personalized foods and DNA diet. Infact here genes decide what should we eat." Dr Shilpi Sharma, associate professor, Department of Biochemical Engineering & Biotechnology, Indian Institute of Technology, Delhi took the participants through safety and efficacy issues in probiotics. "There are 3-5 pound microbes sitting in our gut. This is interesting becasue it shows their importance in our lives." The second plenary session is focussed on analysing Indian nutraceutical sector, pin point issues and find probable solutions. Well known consumer rights protection activist, Mr Bejon Misra, founder and director, Partnership for Safe Medicines India spoke on safety and consumer perspective for nutraceuticals in India. "This is a serious business that has everything to do with the people. Product liability act is missing," he cautioned the companies. Mr Kaushik Basu, EVP Food and Agri Business, Yes Bank while speaking on medicinal and aromatic plant Indian market scenario, pointed towards the rapid urbanization, deforestation, low levels of standard technology and quality of crop seeds. He was critical of the lack of enough promotion. In his presentation, Mr Anil Joshi, CEO, GCV Life talked about need for innovations in this field. ]]> <![CDATA[Merck Serono and BioMed X extend collaboration ]]> https://biospectrumindia.com/news/95/7181/merck-serono-and-biomed-x-extend-collaboration-.html https://biospectrumindia.com/news/95/7181/merck-serono-and-biomed-x-extend-collaboration-.html Mon, 27 Jul 2015 13:12:42 +0530 BioMed X Innovation Center has announced that they have extended their collaboration with Merck Serono, on new approaches for cancer therapy. Based on the results presented at the biannual meeting July 10th in Heidelberg, Germany, Merck Serono has decided to extend the funding of the first two international research groups for a third year. BioMed X and Merck have jointly developed a unique innovation model which combines a crowdsourcing approach with local incubation of the brightest ideas and research talents. Merck became the first partner of the BioMed X Innovation Center in 2013 by setting up three research groups at the interface between academia and industry in its biomedical research lab in Heidelberg. As part of BioMed X's innovation model, outstanding lifescience talents from leading academic institutions world-wide were selected to work on metabolism and signaling in cancer, on tools to improve the selectivity of kinase inhibitors and on new approaches to overcome the immunosuppressive microenvironment of tumors. One of the latest successes was the release of KinMap, a free web-based tool for creating and sharing interactive annotations of the human kinome tree (kinhub.org/kinmap). "We are impressed with the progress achieved by the teams since the start of the projects two years ago. It is great to see that the new open innovation concept we have developed works so well in practice," said Mr Ulrich Betz, head, innovation and entrepreneurship incubator, Merck Serono. "Merck Serono's decision to extend its funding of our first two research groups marks an important milestone for our center. It clearly indicates that our new innovation model creates real value for the pharmaceutical industry," said Mr Christian Tidona, founder and MD,BioMed X. ]]> <![CDATA[Sanofi buys rare disease therapy from AstraZeneca]]> https://biospectrumindia.com/news/95/7179/sanofi-buys-rare-disease-therapy-from-astrazeneca.html https://biospectrumindia.com/news/95/7179/sanofi-buys-rare-disease-therapy-from-astrazeneca.html Mon, 27 Jul 2015 13:12:15 +0530 Sanofi and its subsidiary Genzyme have announced that they have entered into a definitive agreement with AstraZeneca to acquire Caprelsa (vandetanib), a rare disease therapy, indicated for the treatment of symptomatic or progressive medullary thyroid carcinoma in patients with unresectable locally advanced or metastatic disease. Caprelsa is an oral kinase inhibitor treatment and is currently available in 28 countries. Caprelsa is in Phase III development for differentiated thyroid carcinoma, with the study expected to finish in the second half of 2015. "The addition of Caprelsa represents a strong strategic fit for our rare Endocrinology portfolio and underscores Genzyme's commitment to addressing unmet needs in the thyroid community. We look forward to bringing our rare disease expertise to appropriate patients with advanced stage thyroid carcinoma," said Dr David Meeker, president and CEO, Genzyme. The acquisition builds on Genzyme's long-standing commitment and scientific leadership in the field of endocrinology globally. Under the terms of the agreement, Genzyme will pay AstraZeneca up to $300 million, including an upfront payment of $165 million to acquire the global rights to sell and further develop Caprelsa, and further development and sales milestone payments of up to $135 million. The transaction does not include the transfer of any AstraZeneca employees or facilities. Mr Luke Miels, executive vice-president, global product and portfolio strategy and corporate affairs, AstraZeneca, said, "Caprelsa is a rare disease therapy and the divestment to Genzyme, an expert leader in endocrinology, demonstrates our commitment to ensure patients continue to have access to this medicine while we sharpen our focus on key disease areas." The transaction is subject to closing conditions, including the receipt of antitrust clearance from the US Federal Trade Commission. The transaction is expected to complete in the second half of 2015. ]]> <![CDATA[Medicines: Veg or Non-veg?]]> https://biospectrumindia.com/news/95/7061/medicines-veg-or-non-veg.html https://biospectrumindia.com/news/95/7061/medicines-veg-or-non-veg.html Sun, 26 Jul 2015 08:30:00 +0530 Singapore: If reports are to be believed, vegetarian and non-vegetarian capsules will soon hit the Indian market, offering new choice to patients. According to a report by a leading daily, a panel of experts will soon hold a meeting to decide on the material to make capsule shells. Capsules shells can be made of cellulose or gelatin, while gelatin has been the norm since long. Cellulose is derived from plants while gelatin is a product obtained from the connective tissues, skin, bones, etc of animals. The advisory panel and the Drug Controller General of India (DCGI) will decide in the meeting whether cellulose capsule shells should be included in the Indian Pharmacopoeia Commission or not, the report suggests. With vegetarianism and vegan diet becoming popular, drugmakers believe that there is a high demand for good quality vegetarian capsules. Experts also stated that vegetarian capsules have low moisture content and hence are inherently stable thus increasing their shelf life. For cellulose to become mandatory in capsules, it would require an amendment in the Drugs and Cosmetics Bill. ]]> <![CDATA[Compulsory licensing: A nightmare awaiting pharma MNCs?]]> https://biospectrumindia.com/features/95/3778/compulsory-licensing-a-nightmare-awaiting-pharma-mncs.html https://biospectrumindia.com/features/95/3778/compulsory-licensing-a-nightmare-awaiting-pharma-mncs.html Sun, 26 Jul 2015 08:14:00 +0530 Saxagliptin (Onglyza) is a drug used in treating type-2 diabetes. Initially, the molecule was discovered and developed by Bristol-Myers Squibb (BMS) and was later, in 2007, joined by AstraZeneca (AZ) to further develop and commercialize the product. Saxagliptin's history Between the co-developmental period 2007 through 2009, AZ solely bore the developmental costs, post which both the companies shared their spending for other additional costs incurred. In the beginning of 2014, AZ acquired the entire BMS' diabetes business through a staggering $4 billion transaction. The acquisition gave AZ complete ownership of all the intellectual properties (IP) and global rights for developing, manufacturing and commercializing BMS' diabetes drugs, which included Saxagliptin among others. Now it's Lee vs AZ Recently, on June 25, 2015, Lee filed its application with the patent controller asking for the issuance of compulsory licensing for the manufacturing of Saxagliptin under the grounds that the reasonable requirements of the public with respect to the patented invention (Saxagliptin) have not been satisfied by AZ; the patented invention is not available to the public at a reasonably affordable price; and that the patented invention has not worked in the territory of India. According to the Indian Patent Law, patents are granted so that the products are manufactured in India. "Sec 83 of the Indian Patent Act clearly says that patents are granted to the owner neither just to enjoy the monopoly nor to import the product. Astra has been doing it even after the patent grant for the last seven or eight years," commented Mr Afzal Hasan, advocate, patent and trademark attorney and managing partner, Hasan and Singh. "AstraZeneca has agreed to a certain extent that it has not been able to supply the population needs adequately. If we look at the number of people suffering from diabetes in India - their age and financial status - surely this is no more a rich-man's disease anymore. It (AZ) can sell the drug at much lower prices than what it is. AstraZeneca can manufacture the drug in India and bring down the prices rather than importing. We (Lee) have already told Astra that we have developed a process and are in a position to manufacture the drug in bulk at a lower price, and if interested, will supply it to Astra," explained Mr Hasan. AZ sells the drug for Rs 43/- and Lee, if granted compulsory license, is intending to sell it between Rs 20 to 25. Gliptins market India as a country is a home to 65.1 million diabetes patients. By 2035, this value will see a jump to 110 million, according to International Diabetes Federation (IDF) 2014. Globally, diabetes caused at least $ 612 billion health expenditure in 2014. About 80 percent of the patients live in the middle- or low-income countries worldwide. The total market for diabetes medication in India is valued at Rs 6,500 crore. IMS Health estimates that gliptins are valued at Rs 1,258 crore, which is 19 percent of the total market. The total number of patients on gliptin therapy in India is less than five percent out of the entire diabetic population, reflecting the high cost of gliptin products. Tight lipped In November 2014, Lee Pharma submitted all the documents to AZ showing its R&D capabilities, manufacturing facilities, infrastructure, and marketing abilities, to manufacture Saxagliptin. However, there has been no communication from AZ's side so far. Earlier in 2012, Indian patent office issued the first landmark compulsory license to generic maker Natco Pharma to manufacture German-based Bayer AG's Sorafenib (Nexavar), a cancer drug. A year later, in 2013, another compulsory licensing application was filed by Mumbai-based BDR Pharmaceutical International, for the manufacture of generic version of BMS' cancer drug Dasatinib (Sprycel). However, this time, the patent office rejected its application on the grounds that it has 'failed to make out a prima facie case for the making of an order under Section 87 of the Act'. BDR was not available for comments when approached by BioSpectrum. Now, what is the status of Lee's application filed at the controller's office? "There is no reason for the controller to reject our application," said Mr Hasan. "We have not received any form of communication from the controller as of now, but soon we will be, maybe in the next 6 months. Astra will have the opportunity to oppose this." The controller has the power to judge whether this issue will need more time. "He has the right to reject the application if the manufacturing requirements and complex infrastructure needed to make the product is not available," Mr Hasan remarked. Impact on Indian market As far as Indian market is concerned, if the compulsory licensing is granted to Lee, it will have a positive impact on Indian generic companies, believe experts. "Most MNCs take Indian laws for granted. This will be a strong message to all the MNCs who have received Indian patents but do not follow the rules under which the patent has been granted," Mr Hasan pointed. AZ has the patent in India and it was supposed to manufacture the drug in India than importing. "In a way they are abusing the law. One has to follow the law and manufacture it within India. AZ cannot stop or deny the licensing to other companies to enjoy its monopoly by manufacturing overseas and importing it into India," added Mr Hasan. Whether the drug is manufactured or imported, companies will have to supply as per the country's requirements and keep the pricing under control. Mr Hasan held that AZ cannot have such a monopoly that it fixes its own prices though it has a huge margin. "If you are fixing the price for Indian customers, you have to keep in mind who the customers are and their income levels. You cannot sell the drugs equivalent to the prices in the US or Europe," he argued. Do MNCs incur huge costs in their drug discovery R&D? Most of them respond with a big 'Yes'. "I don't agree with that," defended Mr Hasan. "When a patent is granted, the company is able to recover the incurred R&D costs in a year or two. Companies cannot recover their entire R&D costs from Indian patients. This applies to Indian pharma companies as well. Majority of the Indian patients suffer from different diseases and are poorer with mere incomes and below poverty line." Lee's application to obtain the license will be only within India. If needed, it will supply the API to other countries, it said. Now what for MNCs? According to Mr Hasan, under the application, there is a provision for companies to oppose. "It will have a negative impact on MNC pharma companies' commercial interest and they will oppose it. Thus, especially, the US has been attempting to remove section 3(D) of the Indian patent act. It is now the responsibility of the Indian government to first keep its country's population on top priority," ended Mr Hasan. When BioSpectrum approached AZ's local and international offices for their next course of action, the emails went unanswered as on July 23, 2015. BMS too, did not respond. Glenmark Pharma, on July 22, 2015, launched its diabetes drug, Teneligliptin, under the brand names Ziten and Zita Plus in Bangalore, which is used in treating type-2 diabetes, selling at the rate of Rs 19.90 per tablet. Glenmark claimed that it is the only company in India to manufacture gliptins from API to formulation. When asked will the compulsory licensing of Saxagliptin pose any threat to Teneligliptin, the company said, "We are not in a position to comment on this at the moment. But we will have to wait and watch." ]]> <![CDATA[Will the new diabetes drug in the block address affordability?]]> https://biospectrumindia.com/features/95/7247/will-the-new-diabetes-drug-in-the-block-address-affordability.html https://biospectrumindia.com/features/95/7247/will-the-new-diabetes-drug-in-the-block-address-affordability.html Sat, 25 Jul 2015 08:59:00 +0530 Teneligliptin is a selective DPP4 inhibitor, which suppresses glucagon release and increases insulin release in the body. Originally the molecule was created by Japanese pharma firm Mitsubishi Tanabe, which received the marketing authorization in 2012. India as a country is a home to 65.1 million diabetes patients. By 2035, this value will see a jump to 110 million, according to International Diabetes Federation (IDF) 2014. Globally, diabetes caused at least $612 billion health expenditure in 2014. About 80 percent of the patients live in the middle- or low-income countries worldwide. The total market for diabetes medication in India is valued at Rs 6,000 crore. IMS Health estimates that gliptins are valued at Rs 1,258 crore, which is 19 percent of the total market. The total number of patients on gliptin therapy in India is less than 5 percent out of the entire diabetic population, reflecting the high cost of gliptin products. Glenmark claims that it wishes to kick-start the launch process of this new drug in Bangalore mainly because it considers Karnataka State to be one of its key markets and that the disease burden is more in the Southern region. According to Associated Chambers of Commerce of India (ASSOCHAM), Bangalore has approximately 26.5 percent of adult diabetes population. Globally, India has the second largest diabetes population (67 million), overtaken by China (98.4 million), and US next only to India (22.4 million). In the US, diabetes is listed as the 7th leading cause of death. "Diabetes impacts the entire human body and it is not just about elevated sugar levels in the system. One percent of blindness globally is attributed to diabetes. The risk of lower limb amputations are 10 times more common in diabetes patients; and diabetes is the leading cause of renal failure, and the risk of TB is three times higher in them," revealed Mr Sujesh Vasudevan, president & head - India business, Glenmark Pharmaceuticals. Initially when a person is diagnosed with diabetes, the first approach any physician would recommend is healthy eating, weight control and increased physical activity. The first line of therapy is patients would be prescribed Metformin. The second line of therapy would be four options including Sulfonylurea, Thiazolidinedione, DPP4 inhibitors and GLP-1 receptor agonist. Of which, DPP4 has emerged as the preferred choice of therapy mainly because of lower hypoglycemia risk and rare side effects, but is said to be expensive. Glenmark claims that Teneligliptin is once-a-day dose, showing effective reduction of glucose before and after meals, safe and well tolerated, and is excreted through renal and hepatic routes. The pill also is said to be weight neutral and has low-risk of hypoglycemia. The API for the drug is manufactured in bulk at Glenmark's facility in Ankleshwar, and the tablets at its Sikkim plant. Other gliptins available in India include: Januvia 100mg (sitagliptin) supplied by Merck Sharp & Dohme at Rs 45; Istavel 100mg (sitagliptin) manufactured by Sun at Rs 45; Vysov 50mg (vildagliptin) manufactured by Emcure at Rs 42.7; Tradjenta 5mg (linagliptin) manufactured by Boehringer at Rs 42.7; Galvus 50mg (vidagliptin) by Novartis sold at Rs 42.7; Jalra 50mg (vidagliptin) by Novartis at Rs 42.7; Zomelis 50mg (vidagliptin) manufactured by Piramal and sold at Rs 42.7; and Onglyza 5.0 (saxagliptin) by AstraZeneca priced at Rs 41.5. The clinical trials for this new drug was conducted in 237 patients with type-2 diabetes over a period of 2 years across 24 sites, both in government and private hospitals. Glenmark claimed that it is the only company in India to manufacture gliptins from API to formulation. The drug maker which is valued at Rs 7,000 crore, currently has 4-5 molecules in its pipeline. India is the second largest market for Glenmark. Its diabetes business alone is valued at Rs 100 crore. Depending on the demand, Glenmark would manufacture Teneligliptin as required. When BioSpectrum asked will the compulsory licensing grant filed by Hyderabad-based Lee Pharma against AstraZeneca for the manufacture of diabetes drug Saxagliptin pose any threat to Teneligliptin, the company said, "We are not in a position to comment on this at the moment. But we will have to wait and watch." ]]> <![CDATA[Indian pharma in need of digital pill says report]]> https://biospectrumindia.com/news/95/6864/indian-pharma-in-need-of-digital-pill-says-report.html https://biospectrumindia.com/news/95/6864/indian-pharma-in-need-of-digital-pill-says-report.html Sat, 25 Jul 2015 08:01:00 +0530 Most pharmaceutical companies in India - both multi-nationals as well as domestic are still shying away from leveraging the huge opportunities that exist on the digital platforms, a new study released by D Yellow Elephant (www.dyellowelephant.com) on July 22, 2015 revealed. Titled 'Indian Pharma Digital Health Report 2015', this first-of-its-kind report analyzed as many as 40 pharmaceutical companies in India across 10 key digital parameters, ranging across websites, apps and 10 social media platforms, namely Twitter, Facebook, LinkedIn, YouTube, Google+, Instagram, Pinterest, Vine, Slideshare and Blogger. The report has segregated all firms in key buckets of Digital Primes, Aspirants and Onlookers basis analyzes of presence, engagement, response, and consumer followership among few key parameters. According to Mr Aman Gupta, managing director of D Yellow Elephant, "The Pharmaceutical sector in India, whether Indian companies or global players, they are atleast 5-7 years lagging behing there global counterparts and if compared to other sectors, the time lag could go upto 10 years and above. Ironically, some of these same companies abroad are seen to be proactively using digital platforms to engage with health care professionals (HCPs) and patients," he said, explaining that this report is an attempt to help the pharmaceutical sector entities in India catch up on the time gap, identify the loopholes and help them incorporate digital medium in part of the decision making process. Highlighting the key findings of the report, Ms Chandni Dalal, lead, Digital Strategy at D Yellow Elephant said, "Out of 40 companies surveyed, only nine companies managed a score above 50 over a scale of 100 points. This shows the reluctance to effectively engage with their stakeholders on the digital platform." "The report is an attempt to underline the opportunities that exist and draw a roadmap for these pharmaceutical companies in India to engage better with the HCPs, and the patient community," she said that with the advent of smartphones across geographies, it is high time that the potential is realized. "What better way than effectively use these platforms to bridge the gap to healthcare access in a country like ours," she explained. According to Ms Dalal, "Some of the results have been predictive with LinkedIn emerging as the most popular social media platform, with 95 percent presence; but only about 14 companies showing an active engagement. For their part, pharmaceutical companies in India are venturing on the digital highway, but basic building blocks like having an India specific website is still amiss." Only 30 percent companies have an India specific website. In the age of quantified self, Indian patients and HCPs are exhibiting an expectations market, with the advent of digital health, big data and dialogue exchange; Indian pharma has long stayed behind the curve on social media. ]]> <![CDATA[Biocon's earnings surge in Q1 FY16]]> https://biospectrumindia.com/news/95/6947/biocons-earnings-surge-in-q1-fy16.html https://biospectrumindia.com/news/95/6947/biocons-earnings-surge-in-q1-fy16.html Fri, 24 Jul 2015 11:53:28 +0530 Biocon announced that it has delivered a strong consolidated financial performance for Q1 FY16. Commenting on the quarterly performance and highlights, Chairperson and Managing Director, Kiran Mazumdar-Shaw stated: "The strong performance this quarter reflects the overall growth of our business backed by a combination of product sales and monetization of R&D assets through licensing. Our Biosimilars strategy is playing out well with five programs in phase 3 clinical development. During the quarter we successfully licensed biosimilar Trastuzumab in key emerging markets. Our Insulins business was boosted with the launch of insulin Glargine in Mexico and Colombia. Our focus on key brands in Branded Formulations has begun to translate into a better quality of earnings." Highlights: Ã˜ Dr Narendra Chirmule, appointed as Head of Biocon's R&D. Ã˜ Two new biosimilar molecules, Pegfilgrastim (PEG-G-CSF) and Adalimumab have entered Global Phase 3 clinical trials, taking the tally to five partnered programs in Phase III clinical development, others being; Trastuzumab, insulin Glargine and Bevacizumab. Ã˜ The Insulins Drug Products facility in Malaysia successfully completed a cGMP audit by Malaysia's National Pharmaceutical Control Bureau (NPCB). Ã˜ INSUPen and INSUPen EZ received GDPMD (Good Distribution Practice for Medical Device) Certification in Malaysia. Financial Highlights: Q1 FY16 : In Rs Crore, except growth numbers Q1 FY16 Q1 FY15 Growth (%)Revenue 857 742 15EBITDA 236 191 24Net Profit 126 103 23R&D Expenses in P&L 50 31 60Total R&D Spends 93 63 47EBITDA Margin 28 26 N/A Net Profit Margin 15 14 N/A Business Performance Biopharmaceuticals The Biopharmaceuticals segment benefitted from a strong contribution from its Insulins and biosimilars business in the emerging markets. Our partner, Denmark headquartered Veloxis, received USFDA approval for its proprietary Envarus XR formulation (tacrolimus extended release tablets) for prophylactic use in kidney transplant patients, the company said. "We have established a new entity Biocon Pharma, to support our finished dosage generics business. We see this as an important future growth driver.Two licensing deals were signed in key emerging markets for Trastuzumab. Significant inroads were made in Mexico and Colombia with the launch of insulin Glargine," Biocon said in a statement. Dr Kiran added, "Our Insulins drug product facility in Malaysia, underwent a cGMP audit by the National Pharmaceutical Control Bureau (NPCB), Malaysia. We expect to receive the formal certification in a few weeks. This will be followed by the initiation of the validation batches for the drug product." Biocon's partnered programs in generic insulin analogs and biosimilars, continue to advance in the clinic. While the global phase III clinical trials for Trastuzumab and Pegfilgrastim are progressing towards completion, the patient recruitment for the global phase III trials of insulin Glargine for both type 1 and type 2 diabetes studies have been completed this quarter. Branded Formulations Biocon's strategy of optimizing its product offering with a focus on key brands has begun to bear fruit as reflected in the 14% sequential growth (QoQ) with sales of Rs 112 crore in Q1FY16. This performance was led by the metabolics, nephrology and market access divisions. "We continue to grow well in the addressable Insulins market, with a growth of 20%, against the market growth of 14%. CANMAb, our affordable biosimilar Trastuzumab continues to gain traction as a life-saving therapy for HER2-positive metastatic breast cancer patients," Biocon stated. Novel Molecules A scientific paper titled 'Long-term Efficacy and Safety of Itolizumab in Patients with Moderate-to-Severe Chronic Plaque Psoriasis,' authored by Dr Sunil Dogra, additional professor from PGI Chandigarh with other Key opinion leaders in dermatology and Biocon's R&D team, has been published in the prestigious Journal of American Academy of Dermatology, which profiles the unique attributes of our novel anti-CD6 monoclonal antibody leading to positive patient outcomes. Appointments Dr Narendra Chirmule, has been appointed as the Head of R&D at Biocon. He has taken over from Dr Abhijit Barve, who has moved back to the US for personal reasons. Dr Chirmule held senior leadership positions at Amgen and Merck, in the US, in the departments of clinical immunology overseeing drug development for regulated markets. He holds a PhD from Cancer Research Institute, University of Mumbai, with post-doctoral training at Cornell University Medical College, and has teaching and research experience as an assistant professor in the Human Gene Therapy Group of University of Pennsylvania. ]]> <![CDATA[Lupin acquires GAVIS to expand US generic business]]> https://biospectrumindia.com/news/95/6928/lupin-acquires-gavis-to-expand-us-generic-business.html https://biospectrumindia.com/news/95/6928/lupin-acquires-gavis-to-expand-us-generic-business.html Fri, 24 Jul 2015 11:36:24 +0530 Lupin has entered into a definitive agreement to acquire privately held GAVIS Pharmaceuticals and Novel Laboratories (GAVIS), subject to certain closing conditions, in a transaction valued at $880 million, cash free and debt free. The transaction has been unanimously approved by the Boards of Directors of Lupin and GAVIS. New Jersey based GAVIS is a privately held company specializing in formulation development, manufacturing, packaging, sales, marketing, and distribution of pharmaceuticals products. The acquisition enhances Lupin's scale in the US generic market and also broadens Lupin's pipeline in dermatology, controlled substance products and other high-value and niche generics. GAVIS brings to Lupin a highly skilled US based R & D organization which would complement Lupin's Coral Springs, Florida, inhalation R&D center. GAVIS's New Jersey based manufacturing facility will become Lupin's first manufacturing site in the US. Commenting on the acquisition, Ms Vinita Gupta, CEO, Lupin said, "This is a pivotal acquisition for Lupin as it aligns with our goal to expand and deepen our US presence. GAVIS has a strong track record of delivering highly differentiated products in a short time and is poised for continued strong growth as it delivers on its existing pipeline." She added, "GAVIS's capabilities and pipeline are an excellent complement to Lupin. The acquisition accelerates Lupin's entry into niche areas like controlled substances and dermatology. We are confident that Lupin's proven commercialization capabilities, vertically integrated manufacturing operations and supply chain strengths will accelerate GAVIS's growth." Dr Veerappan Subramanian, founder and CEO of GAVIS said, "This is a time of globalization for the specialty pharmaceutical industry and GAVIS is well positioned to capitalize on this exciting opportunity. Joining forces with Lupin, a truly global player, will help realize our vision of building a broader, research-based high value, specialty business through organic growth. I am confident that the combined entity will be a powerhouse in the US specialty space and will significantly enhance Lupin's US platform." ]]> <![CDATA[Can't speculate on future activities at Thane's plant: Pfizer]]> https://biospectrumindia.com/features/95/7765/cant-speculate-on-future-activities-at-thanes-plant-pfizer.html https://biospectrumindia.com/features/95/7765/cant-speculate-on-future-activities-at-thanes-plant-pfizer.html Fri, 24 Jul 2015 10:49:22 +0530 During this time, it produced a number of medicines, for both domestic and international markets. Practically there was no production activity at the plant since 2013. Hence the company announced its decision to shut it down by 2016. The closure, according to Pfizer, will not impact the supply of any of its medicines, it told BioSpectrum in an email. The facility employed 212 professionals and the company had offered a generous voluntary retirement scheme (VRS) to the workmen last year upon their request, said Pfizer. The VRS has been taken up by as many as 132 employees out of the 212 workmen. "The remaining 80 workmen have continued to receive full wages, despite plant inactivity. As a part of the closure process, the company will honour its obligations towards requisite compensation, as mandated by law, for the remaining workmen," the company's spokeswoman said. When asked if the facility would be given away to be converted in to an incubator, Pfizer commented, "We cannot speculate on future activities." In another incident parallely, drug maker Sandoz too announced its plans to lockup its Turbhe site in Maharashtra. Last year, in August 2014, Piramal officially vocalized its decision to shut its Mumbai R&D unit. "I think the regulatory bottlenecks are slowing down research and innovation. I hope it will change with the new government," told Dr Swati Piramal, vice chairperson, Piramal Enterprises, in an interview to BioSpectrum last year. Also, in January 2014, AstraZeneca announced the shutting down of its iconic Avishkar R&D site in Bangalore. ]]> <![CDATA[Diabetes affecting productive age groups: study]]> https://biospectrumindia.com/news/95/6856/diabetes-affecting-productive-age-groups-study.html https://biospectrumindia.com/news/95/6856/diabetes-affecting-productive-age-groups-study.html Thu, 23 Jul 2015 14:02:02 +0530 Diabetes is fast gaining an epidemic status in India. According to an estimate drawn by the Indian Medical Council of Research in 2014, there are about 77.2 million people in India suffering from pre-diabetes and over 65.1 million diabetes patients. India is second only to China in the number of reported cases of diabetes. By 2030, India is estimated to the diabetes capital of the world. Despite increasing awareness of diabetes and its life-altering complications, very few people undergo regular screening tests proactively to prevent disease. The aetiology of diabetes in India is multifactorial and includes genetic factors coupled with environmental influences such as obesity associated with rising living standards, steady urban migration, and lifestyle changes. An upsurge in number of early-onset diabetes cases is also responsible for the development of various diabetic complications due to longer disease duration. In an analysis of over 49,788 samples tested for Fasting Blood Glucose* at Metropolis Healthcare Ltd, a leading chain of multi-national diagnostics, the following are the findings Age Group (yrs) Normal Pre-Diabetes Diabetes Total 20 to 30 9214 977 333 1052430 to 40 7484 1816 1379 1067940 to 50 5063 2473 2433 996950 to 60 3388 2588 3046 902260 to 70 2359 2088 2184 663170 to 80 1124 986 853 2963 Total 28632 10928 10228 9788 Out of the 49,788 samples processed between the age group 20 to 80 yrs, over 10,228 samples were found to be positive for Diabetes Mellitus and over 10,928 samples were found to be in a pre-diabetic condition which constitutes high risk group for developing diabetes. 20.54 percent - Diabetes Mellitus | 21.95 percent - Pre-diabetes In a percent analysis of overall samples, it was observed that there is an increasing trend with progression in age. Gender Normal Pre-Diabetes Diabetes % of pre-diabetic % of diabetic Female 17070 5416 4724 27210 19.90 17.36Male 11562 5512 5504 22578 24.41 24.38 Out of the 49,788 samples, the following are the gender wise break-up: â€¢ 20 percent of females were found to be pre-diabetic and 18 percent were found to be diabetic. â€¢ Over 25 percent of the samples in males were found to be pre-diabetic and another 25% were diabetic which brings to a conclusion that 1 in 2 males are either pre-diabetic or are suffering from diabetes. An increasing trend is noticed both in male and females with a progression in age. Males are seen at a marginally higher risk for diabetes from the data analysis. Diabetes mellitus is reaching potentially epidemic proportions in India. The level of morbidity and mortality due to diabetes and its potential complications are enormous, and pose significant healthcare burdens on both families and society. Worryingly, diabetes is now being shown to be associated with a spectrum of complications and to be occurring at a relatively younger age within the country. Screening for diabetes should begin when you hit 30 to prevent disease. ]]> <![CDATA[BMS's HIV drug gets FDA breakthrough status]]> https://biospectrumindia.com/news/95/7831/bmss-hiv-drug-gets-fda-breakthrough-status.html https://biospectrumindia.com/news/95/7831/bmss-hiv-drug-gets-fda-breakthrough-status.html Thu, 23 Jul 2015 12:59:55 +0530 Bristol-Myers Squibb (BMS) has announced that the US Food and Drug Administration (US FDA) has granted Breakthrough Therapy Designation to the investigational compound BMS-663068, when used in combination with other antiretroviral (ARV) agents for the treatment of HIV-1 infection in heavily treatment-experienced adult patients. BMS-663068 is an oral prodrug of the molecule BMS-626529 and first-in-class HIV-1 attachment inhibitor. The attachment inhibitor is designed to work differently than entry inhibitors, a current class of drugs that targets co-receptors' activity or fusion after HIV attaches to the CD4+ host cell. BMS-663068 is thought to work at an earlier point in the replication process to prevent the virus' initial interaction with immune cells entirely, and thus blocks its entry into the cell. The designation is based on data from the Phase IIb clinical study comparing BMS-663068 to a boosted protease inhibitor (Reyataz (atazanavir sulfate) and ritonavir) in treatment-experienced patients, with a treatment backbone across all arms of raltegravir, in addition to tenofovir disoproxil fumarate. Week 48 results from the Phase IIb trial were presented earlier this year at the 22nd Conference on Retroviruses and Opportunistic Infections (CROI) and supported the continued clinical development of the attachment inhibitor. A Phase III trial in heavily treatment-experienced patients (defined as individuals who can no longer formulate a viable three-drug treatment regimen due to accumulation of drug resistance, past intolerabilities or antiretroviral contraindications) began in February 2015 and is ongoing. "We are now 30-plus years into the AIDS epidemic, and there is an ever-increasing number of long-term survivors of the condition, many of whom are facing issues of drug resistance and are in need of new treatment options," said Mr Douglas Manion, head of specialty development, Bristol-Myers Squibb. He added, "The Breakthrough Designation recognizes the unmet need for novel therapies for this growing group of heavily treatment-experienced patients, and is evidence of Bristol-Myers Squibb's continued focus on meeting that need." Breakthrough Therapy Designation expedites the development and review of new therapies meant to treat serious or life-threatening conditions. The criteria for Breakthrough Therapy Designation require preliminary clinical evidence that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints. The Designation for BMS-663068 is a significant milestone and will help speed development of the investigational compound for heavily treatment-experienced patients. ]]> <![CDATA[EU approves Merck's Keytruda for melanoma]]> https://biospectrumindia.com/news/95/7360/eu-approves-mercks-keytruda-for-melanoma.html https://biospectrumindia.com/news/95/7360/eu-approves-mercks-keytruda-for-melanoma.html Thu, 23 Jul 2015 11:21:23 +0530 Merck has announced that the European Commission has approved KEYTRUDA (pembrolizumab), its anti-PD-1 therapy, for the treatment of advanced (unresectable or metastatic) melanoma in adults. The European Commission approval of KEYTRUDA is based on data from three clinical studies conducted in more than 1,500 first-line and previously-treated patients with advanced melanoma. KEYTRUDA received European Commission regulatory approval based on Phase 3 data which showed it is the first and only anti-PD-1 therapy to provide a statistically superior survival benefit as a monotherapy compared to ipilimumab, the current standard of care for advanced melanoma. This approval allows marketing of KEYTRUDA in all 28 EU member states at the approved dose of 2 mg/kg every three weeks. "European approval supports our goal of accelerating immuno-oncology research for the benefit of patients around the world," said Dr Roger M Perlmutter, president, Merck Research Laboratories. He added, "We believe that the broad data set supporting this approval helps illustrate the significant potential of KEYTRUDA to treat advanced melanoma, a devastating disease." "Merck has long-believed that innovation and access must go hand-in-hand, which is why we work to bring forward new innovations, and ensure access to those innovations," said Mr Deepak Khanna, senior vice president and regional president, Europe, MSD Oncology. He added, "Merck is committed to working collaboratively with governments and other stakeholders to ensure that KEYTRUDA will be made available to advanced melanoma patients in Europe as rapidly as possible." ]]> <![CDATA[Sphaera Pharma, THSTI & Wellcome Trust to jointly develop drug for resistant TB]]> https://biospectrumindia.com/news/95/7023/sphaera-pharma-thsti-wellcome-trust-to-jointly-develop-drug-for-resistant-tb.html https://biospectrumindia.com/news/95/7023/sphaera-pharma-thsti-wellcome-trust-to-jointly-develop-drug-for-resistant-tb.html Thu, 23 Jul 2015 08:26:00 +0530 Sphaera Pharma (India), a subsidiary of Sphaera Pharma (Singapore), and the Drug Discovery Research Centre (DDRC) of the Translational Health Science and Technology Institute (THSTI) have received funding from The Wellcome Trust to develop a novel, first-in-class, therapeutic for the treatment of multiple drug resistant (MDR) and extensively drug resistant (XDR) tuberculosis (TB). This is based on a unique approach, first identified at the International Centre for Genetic Engineering and Biotechnology (ICGEB), that targets a host protein. The approach has the potential to be more effective, and is less likely to result in development of drug-resistance. It is also expected to work in conjunction with current therapies. The incidence of MDR and XDR TB are on the rise and current treatments are not very effective, with long treatment regimens and significant side effects. Hence there is urgent need for the development of new anti-TB drugs that are cheaper, easily available, more effective and require a shorter treatment period. India also has one of the world's highest burden of tuberculosis with approximately 66,000 MDR-TB (Multiple Drug Resistant TB) cases among notified pulmonary TB cases in 2011. Dr Sundeep Dugar, CEO, Sphaera Pharma Singapore, has indicated that this novel approach through the collaboration between Sphaera Pharma, India, DDRC and Wellcome Trust has the potential to deliver a first-in-class novel therapy for TB. ]]> <![CDATA[Indigenous non-invasive solution for breast cancer detection]]> https://biospectrumindia.com/news/95/6697/indigenous-non-invasive-solution-for-breast-cancer-detection.html https://biospectrumindia.com/news/95/6697/indigenous-non-invasive-solution-for-breast-cancer-detection.html Wed, 22 Jul 2015 17:24:21 +0530 The rising breast cancer incidence among women is a cause for concern. However, technology has not advanced enough to ensure early detection and treatment. The most prevalent way to detect breast cancer is mammography of the affected area. Unfortunately, mammograms available are all based on X-ray, ultrasound, magnetic-resonance or nuclear isotopes-based image correlation. All these methods of mammography use contrast or nuclear dyes or probes which are invasive. In addition, they affect patient morale, are expensive, and in many cases, don't detect the problem early enough. To address this issue, the Paterson Cancer Center, Indian Institute of Technology, Madras and National Institute of Electronics and Information Technology, Chennai have collaborated to develop an indigenous IR Mammographic Unit for noninvasive, thermal image screening for early breast cancer detection. A memorandum of understanding was signed between the three institutions on July 21st, 2015 at the Paterson Cancer Center, Chennai and the IR Mammographic Unit was inaugurated to carry forward the research. Under this MOU, IIT Madras is responsible for developing the technology (thermal imager and diagnosis software), the Patterson Institute will handle all the clinical issues. National Institute of Electronics and Information Technology will provide all the cameras and computers needed for the success of the project. "The cost of x-ray mammogram through a good quality mammographic device is around 2,000 rupees which would be 7 rupees of the earning per day by a women labor if the checkup needs to be done on a yearly basis. The digitized ultrasound mammogram is not only expensive, it is also inconclusive. This project aims to create a trial of a full-fledged solution to develop a homegrown thermal imaging camera (and associated software) and a mass breast cancer screening program that will bring down the cost of cancer screening from Rs 2,000 to Rs 200 and would be of immense benefit to the society," said Dr S Vijayaraghavan, chief clinical oncologist, Paterson Cancer Center. Prof. Kamakoti Veezhinathan, RISE lab, Department of Computer Science and Engineering, IIT Madras, said, "Our group will focus on developing software and hardware infrastructure that can enable accurate mass screening for breast cancer detection. Our thermo mammogram is noninvasive and records the temperature difference that takes place inside the breast due to increased blood supply, metabolic activities as well as a high glycolysis that are associated with the tumor cell multiplication." Thermal imaging techniques have proven to be useful in screening all kinds of cancer and as a diagnostic tool for arthritic conditions and vascular diseases. Using thermal image techniques can help in detecting changes in the underlying metabolic activity and vascular circulation at the onset of cancerous tumors; this can be done even before the tumors are large enough to be detected by physical examination, mammography or other types of imaging. Commenting on the association, Mr V Krishnamurthy, directo-In-charge, NIELTT Chennai said, "Research shows that you begin learning from small things, for us in NIELIT it is a new beginning of learning to do research and product development and a feather in our cap. This triparty agreement in research will take us to new heights especially with the support of IIT Madras, Chennai and Paterson cancer Center for doing things for Make In India." ]]> <![CDATA[Fidelity to invest in Cipla's consumer healthcare business]]> https://biospectrumindia.com/news/95/6795/fidelity-to-invest-in-ciplas-consumer-healthcare-business.html https://biospectrumindia.com/news/95/6795/fidelity-to-invest-in-ciplas-consumer-healthcare-business.html Wed, 22 Jul 2015 11:16:13 +0530 Cipla has announced that the Company's Board has approved an investment by Fidelity Growth Partners India and US-based Fidelity Biosciences, through FIL Capital Investments (Mauritius) or its affiliates, in its recently launched consumer healthcare business which is under incorporation. The investment is subject to execution of definitive agreements, and regulatory approvals. Through Cipla Consumer Healthcare, the company has entered the rapidly growing over-the-counter (OTC) healthcare market in India. The idea is to leverage Cipla R&D and innovation platform to provide innovative solutions to meet the unmet needs of the Indian consumer. The business will focus on opportunities arising from the shift from illness to wellness and self-care. Ms Samina Vaziralli, executive director, Cipla, who has incubated this business at Cipla New Ventures said, "Partnering with a long-term strategic and financial investor like Fidelity Growth Partners on this journey will help us create a best-in-class consumer healthcare business. In the consumer healthcare business we need a strong FMCG talent pool and the right ecosystem with a 'pharma in/ FMCG out' mind-set. We already have great talent on board." Mr Raj Dugar, senior managing director, Fidelity Growth Partners India, added,"Over-the-counter consumer healthcare is a nascent but rapidly growing market in India, and one we are very excited about. This is a unique opportunity for us to partner with Cipla, a company that has long been associated with changing the paradigm of care to build a robust platform that delivers differentiated, high quality products for the Indian consumer. Using our combined knowledge and resources, we intend to provide OTC products that will bring significant benefits to the consumer." ]]> <![CDATA[Indian diagnostics stuck with traditional testing methods]]> https://biospectrumindia.com/features/95/7130/indian-diagnostics-stuck-with-traditional-testing-methods.html https://biospectrumindia.com/features/95/7130/indian-diagnostics-stuck-with-traditional-testing-methods.html Tue, 21 Jul 2015 15:03:29 +0530 A great need exists for better molecular characterization of tumor tissues in aiding oncology decision-making process, facilitating treatment selection, and improving outcomes.According to GLOBOCAN 's 2012 statistics, breast cancer is a major public health issue and is the leading cause of cancer mortality among women. Globally, it is estimated that over 522,000 women died due to breast cancer in 2012, of which more than 70,000 were from India alone. Breast cancer constitutes 22 percent of female cancer deaths in India. The pattern of breast cancer in India is quite disturbing, and the higher mortality is attributed to the non-availability of screening program. As a result, more than 45 percent of the breast cancer cases are detected at an advanced stage. India-based iLife Discoveries, a genetics and molecular diagnostics company, has introduced MammaPrint, which it claims to be unlike previous generation genomic tests, which evaluates all critical molecular pathways involved in the breast cancer metastatic cascade. "Early screening is the key to decrease the mortality in breast cancer patients because all the patients can have a substantially improved disease-free and overall survival," revealed Dr Shweta Anand, VP, iLife Discoveries. BluePrint, which is a companion test to MammaPrint, helps in re-categorizing up to 25 percent of patients leading to appropriate treatment. The MammaPrint and BluePrint tests are for prognosis and prediction of appropriate treatment. The former is used for patients who have already been diagnosed with breast cancer, helping in predicting the chances of recurrence of cancer, and based on the outcome, the patient can undergo chemotherapy. MammaPrint is an FDA-approved, 70-gene assay, intended as a prognostic test for women of all ages. Through the gene test, patients are stratified into two distinct groups - low-risk (good prognosis) or high risk (poor prognosis) of distant recurrence. Unlike other tests, the patient is given definitive low-risk and high-risk results, eliminating the uncertainty of an intermediate risk score. Oncologists across world today are increasingly relying on genomic tests to tailor treatments for different patients by studying the tumor's biology. Similar tests According to Mr Anand Gupta, CMD, iLife Discoveries, there are similar tests available in the Indian market. The existing tests normally help in the diagnosis of the disease. "...But all of them cater to smaller subgroups of patients. One of the tests provides information, only in patients whose tumors are positive for estrogen receptors, and the test just provides information in post-menopausal breast cancer patients. Moreover these tests give an intermediate result in up to 40% of tested patients, where the doctor as well as patient cannot take an informed decision," he said. MammaPrint is for all the stage I and II breast cancer patients irrespective of estrogen-receptor (ER) or progesterone-receptor (PR), and HER2 status, and provides clear results, either high-risk or low-risk. Chemotherapy no more? Patients under the low-risk category can safely avoid chemotherapy without risking their chances of disease-free survival. However, in the high-risk category, patients have a high-risk of distant metastasis, and there is a statistical significance of treatment with chemotherapy. The test is currently available globally in about 80 counties and iLife has acquired the technology-transfer only for India. The company has entered into various technological tie-ups with leading molecular diagnostic certified labs in USA and Europe to introduce new tests mainly in cardiology, neuropsychiatry and oncology segments. Lack of awareness Every new technology takes its time to be well accepted by the healthcare community, especially the patients. "Lack of awareness about such tests and technology has been a challenge for us," Mr Anand added. Genome testing and personalized genome-based tests have been the cutting edge science in routine healthcare practices for clinicians in most developed countries around the world. "India is still lagging in incorporating such development in their clinical practice. The current diagnostics and treatment model in India largely rely on traditional testing methods. There is a big unmet need of introduction of technological advancements in diagnosis or prognosis in the invitro diagnostic segment, to make an informed treatment decision based on the genetic makeup of an individual," Mr Anand explained. ]]> <![CDATA[FDA nod for IOLCP's manufacturing plant]]> https://biospectrumindia.com/news/95/6517/fda-nod-for-iolcps-manufacturing-plant.html https://biospectrumindia.com/news/95/6517/fda-nod-for-iolcps-manufacturing-plant.html Tue, 21 Jul 2015 12:42:59 +0530 IOL Chemicals and Pharmaceuticals (IOLCP) has announced that the company has received establishment inspection report from the US Food and Drug Administration (USFDA) for its Ibuprofen manufacturing facility in Barnala, Punjab. The company's manufacturing plant already hold CEP certification (certification of suitability) for its product Ibuprofen, Metformin Hydrochloride and Lamotrigine from the European Directorate for the Quality of Medicine and Healthcare (EQDM) authorities, Council of Europe, France. The said facility has also been approved by ANVISA Brazil, WHO and MOH Japan. ]]> <![CDATA[No plans to expand in other Indian cities: US Pharmacopeia ]]> https://biospectrumindia.com/features/95/4879/no-plans-to-expand-in-other-indian-cities-us-pharmacopeia-.html https://biospectrumindia.com/features/95/4879/no-plans-to-expand-in-other-indian-cities-us-pharmacopeia-.html Tue, 21 Jul 2015 12:42:00 +0530 A part of this investment will be made in India. It aims to execute multiple activities in the country including medical monograph modernization, increasing resources, building manpower, and expanding technology-related activities. In 2005, USP opened its first office and collaborative testing laboratory facility outside of the United States, near Hyderabad. "Since USP India's opening, India's pharmaceutical industry has continued to grow rapidly, resulting in an increased demand for USP standards and services," said Dr K V Surendranath, SVP, International Site Operations, USP-India. The USP India facility works to create standards for medicines ensuring full safety and quality of medicines, and brining international standards in drug manufacturing to India. The not-for-profit organization develops reference standards to ensure the quality of Active Pharmaceutical Ingredients (APIs) and supports government's initiatives to strengthen domestic manufacture of intermediaries and APIs. $20 mn in 4 years In 2011, USP expanded from 14,000 square feet to more than 100,000 square feet in a new facility. It has spent over US $20 million over the past 4 years to improve its infrastructure and capacities. This allowed the organization to increase its capacity for analytical chemistry and microbiological testing, and as well as to explore new initiatives in bioanalytical chemistry and testing, and synthetic chemistry. Added Dr Surendranath, "The expansion has been integral to the collaborative testing needed to develop reference materials for the United States Pharmacopeia and the National Formulary (USP-NF)." $200 mn investment Currently USP Hyderabad has a head count of 150 employees, and it plans to expand its capacity, and grow its activities based on local requirements and demands from the industry. ".... As the industry grows and drug testing activities increase, we will continue to increase our capacity and facilities accordingly," pointed Mr Surendranath. Furthermore, in the next 5 years, it plans to spend US $200 million to notch-up its operations across the globe. "This investment will be used to revise at least half of USP's drug testing monographs using the latest technology and drug testing procedures," voiced Dr Surendranath. Working with USFDA Manufacturers that market drug products and their ingredients (active and inactive) in the US are expected to comply with USP's quality standards, and the standards are enforced by the US Food and Drug Administration (USFDA). USP's process for developing and updating standards include incorporating inputs from experts in the industry, academia, and the government, and the USFDA. "In addition, scientific experts from USFDA regularly participate in USP's workshops, forums and related meetings," revealed Dr Surendranath. India site's uniqueness According to USP India, the Hyderabad site is largely involved in activities similar to those at USP's US and other sites, such as collaborative studies for development of reference standard, education, and training programs. Some of the activities which are unique to the India site are the synthetic laboratory, industry support programs, and the site serving as a global hub for tests conducted for USP's verification programs. As of now, the organization does not have any plans in expanding further to other Indian cities. USP and its stakeholders ï‚§ USP works with USP India to improve quality and reference standards for pharmaceutical ingredientsï‚§ It also works with Indian manufacturers on collaborative testing, verification testing, pharmacopeial education, customer support, and sourcing of written and physical standards for drugsï‚§ The organization educates local companies on reference standards besides supporting existing customers ï‚§ The Hyderabad facility has been working in collaboration with various labs for developing reference standards in India ]]> <![CDATA[FIL Capital to invest in Cipla's consumer healthcare business]]> https://biospectrumindia.com/news/95/6514/fil-capital-to-invest-in-ciplas-consumer-healthcare-business.html https://biospectrumindia.com/news/95/6514/fil-capital-to-invest-in-ciplas-consumer-healthcare-business.html Tue, 21 Jul 2015 12:41:05 +0530 Cipla Ltd shareholders have approved a potential investment by FIL Capital Investments (Mauritius) II Limited in its consumer healthcare business. In a filing to the BSE Cipla said that its Board of Directors of the Company at its meeting held on July 20, 2015, have "approved a potential investment by FIL Capital Investments (Mauritius) II Limited, or any of its affiliate in a wholly owned subsidiary of Cipla Limited (proposed to be incorporated) to whom Cipla will be divesting its consumer healthcare business on a going-concern basis." "The approval is subject to execution of binding agreements, and the transaction will be subject to relevant regulatory approvals. None of the persons belonging to Promoter / Promoter Group(s) of the Company has any interest in the transaction", said the filing. ]]> <![CDATA[Hospira announces the US launch of generic Bivalirudin]]> https://biospectrumindia.com/news/95/6385/hospira-announces-the-us-launch-of-generic-bivalirudin.html https://biospectrumindia.com/news/95/6385/hospira-announces-the-us-launch-of-generic-bivalirudin.html Mon, 20 Jul 2015 12:30:36 +0530 Hospira has announced that it has obtained the US Food and Drug Administration (US FDA) approval for the launch of bivalirudin for injection, a generic version of The Medicines Company's Angiomax. Branded sales of Angiomax in 2014 in the United States were approximately $500 million. Hospira's bivalirudin for injection is available in a single-dose flip-top vial, which matches the current branded offering available. In addition, the company plans to launch a differentiated presentation of the 250 mg bivalirudin for injection in its unique ADD-Vantage vial. "Hospira is excited to launch the first generic of bivalirudin based on a successful challenge of the originator's patents. This approval further demonstrates our commitment to bringing safe, lower-cost generic versions of important medications to the market as soon as possible," said Mr Philippe Drouet, president, the US Commercial, Hospira. Available as a lyophilized (powder) format, Hospira's bivalirudin for injection is a direct thrombin inhibitor indicated for use as an anticoagulant in patients With unstable angina undergoing percutaneous transluminal coronary angioplasty (PTCA); Undergoing percutaneous coronary intervention (PCI) with provisional use of glycoprotein IIb/IIIa inhibitor (GPI) as in the REPLACE-2 study, and With, or at risk of, heparin-induced thrombocytopenia (HIT) or heparin-induced thrombocytopenia and thrombosis syndrome (HITTS), undergoing PCI. Bivalirudin is intended for use with aspirin. ]]> <![CDATA[Torrent completes the acquisition of Zyg Pharma]]> https://biospectrumindia.com/news/95/6358/torrent-completes-the-acquisition-of-zyg-pharma.html https://biospectrumindia.com/news/95/6358/torrent-completes-the-acquisition-of-zyg-pharma.html Mon, 20 Jul 2015 12:29:57 +0530 Torrent Pharmaceuticals has announced the completion of its acquisition of Zyg Pharma. on May 05, 2015, the company had announced a share purchase agreement to acquire 100 percent stake in Zyg Pharma. Zyg Pharma is a part of the Encore Group and is engaged in manufacturing various dermatological formulations like creams, ointments, gels, lotions, solutions. "The conditions precedent and closing conditions have been satisfied and the entire equity was transferred to the Company on July 17, 2015," Torrent said in a BSE filing. ]]> <![CDATA[India lacks innovation culture, collaboration is the way forward: Industry]]> https://biospectrumindia.com/views/95/7772/india-lacks-innovation-culture-collaboration-is-the-way-forward-industry.html https://biospectrumindia.com/views/95/7772/india-lacks-innovation-culture-collaboration-is-the-way-forward-industry.html Sun, 19 Jul 2015 09:14:00 +0530 The forum brought India's leading Life Sciences personalities and game changing masterminds to discuss and contemplate the future of Indian Life Sciences industry by the year 2020. The star-studded panel discussion was garnered by eminent faces including Dr K K Narayanan, MD, Metahelix Life Sciences; Dr Rashmi Barbhaiya, CEO & MD, Advinus Therapeutics; Ms Bindhya Cariappa, COO & EVP Emerging Markets, ClinTec International; Dr Goutam Das, COO, Association of Biotechnology Led Enterprises (ABLE); Ms Rooma Bussi, Country Head - India, SDI; and Dr Sharon McKendry, Life Sciences & Chemical Sciences International Sector Head, SDI. The panel discussion was moderated by N Suresh, group editor of BioSpectrum publication. Dr Rashmi began the panel discussion by speaking about the significance of innovation and collaboration in the pharma industry. "Having spent 30 years in the US, I came back for one reason -- the young Indian talents, since there is no past legacy for them. The manner in which young people go about finding innovation is amazing. Many companies from Europe, US and Japan have been in India for a long time. The cost of innovation in their respective countries is high and hence, they lookout for cheaper labor to solve issues," he opined. The event witnessed 40+ attendance ranging from start-up CEOs to industry veterans, from deans of prestige institutes to research scientists and media fellows. "The biggest challenge the industry is facing now is affordability and accessibility of medicines. The pharma innovation has no choice but to be a global network for innovation. Pharma companies need to look for places where innovations can be done best, faster and cheaper. No one company or country can do it all. To bring affordable and innovative medicines, we have to work together," Dr Rashmi emphasized. Dr Binay Panda, Chief Officer & Head, Ganit Labs, said that innovation does not happen in large companies. "Young people need to know how researchers and scientists in labs do innovation, and then take it to the real world. Innovation starts from the labs. We need more innovation success stories," he pointed. Another panel member, Ms Bindhya Cariappa, expressed that India has great potential to perform well in clinical trials. "We are living in challenging times. We have taken a lot of time to get where we are. They key is what difference are we going to make in people's lives and reach out to those who are involved in the healthcare delivery. When we started clinical trials, it was very new. Trials are the only opportunity for treatment and access of diseases. Regulatory reforms takes time. Today there is change in the technology and we need to push certain things. We have the potential to do extremely well in clinical trials. India promises efficiency through leveraging technology which ensures affordability and quality healthcare," she explained. Dr Ajith Kamath, Head, External R&D Innovation, Pfizer India, pointed the significance of collaborations in a globalized world. "Today, two-thirds of the world are touched by vaccines from India. When we look at the big picture, most of the molecules are made in India. Today, about 60-70% of the molecules in the pipeline are coming out of collaborations and not just from one particular company. Collaboration is the way forward. There are many opportunities to collaborate with Indian companies," he held. Dr Raviraja Seetharam, Deputy Director, Business Development, Stempeutics Research stated, "Globally the biopharma industry recorded revenues of US $180 billion, out of which US $5 billion is from India. There is a lack of talent pool. We need to come together, collaborate and globalize products." Dr Sharon shared insights on collaborative innovation and Scotland's offer to companies who want to set up their bases there. "Currently I'm seeing a lot of entrepreneurship and customer focus in companies, as a lot of new technologies are coming up. In Scotland, we have more than 170 core medical devices companies, 140 pharma service organizations, and top 10 global CRO firms. Scotland is the land of innovation, all the way dating back from discovering penicillin to the cloning of the first animal, Dolly," she highlighted. By 2020, the global population will reach 8 to 9 billion. This implies there is going to be increased demand for food, and the demands are going to stem from the developing world. "We are a country of 1.3 billion people, and will touch 1.4 billion plus by 2025. It is estimated that India may need 450 million tons of food grains. Today, we produce about 250 million tons. By 2020, Bangalore, by population, will be twice the size of Scotland. India is second only to US in terms of arable land. 50% of the landmass in India is ploughed allowing no scope for further expansion. As we move forward, the land is going to diminish further. We have to increase the productivity and technology is going to be the key," stressed Dr K K Narayanan. He believes that Indian agriculture is a prisoner of old and outdated technologies. "We are doing well in terms of opportunities. But we are lagging behind in productivity. This is where the opportunity lies. Today we have a burden and a need. There are skills available to do the adaptive. Things can be tested, and yes, we do have challenges of regulatory and activism, but they can be overcome. In our country, I believe, you can only delay things but can't deny, because farmers in the country ultimately get it one way or the other," he voiced. Dr Goutam emphasized how ABLE is involved with the government and other stakeholders to encourage more start-ups. "The challenge is, we definitely want to encourage smaller start-ups in getting funding rather than depending solely on DBT or BIRAC grants. Private equities always look for quicker profits, maturity and exits. In drug discovery this is not the case. ABLE is talking to SEBI and the government to get into these areas where they can support smaller biotech start-ups by replicating the US model, where they can float shares and get into investments. The number of start-ups have definitely increased. Since 2009, we have launched more than 10 to 12 start-ups in different areas," held Dr Goutam. Speaking about the Biodiversity Bill, he revealed, "One of the other issue is that the government should know how to go about biologics, biosimilars and biobetters. We are pushing the government to streamline the process and make things faster by 180 days. We are also trying to address the Biodiversity Bill. We are working with different government forces to find out what the government's position is with the Bill. The Bill is making it impossible to bring things in or to take them out of the country." Dr Rashmi also mentioned the approval pain that companies go through in the drug discovery process. "When we discover a new molecule, we have to make enough quantity of it to obtain approval, which takes months from the Drug Controller General of India (DCGI), to conduct clinical tests in animals and proceed with clinical trials. Every molecule is under patent, and the stakes are high while developing a molecule when we wait for the approval, which can go up to 18 months, when it takes less than a month in other countries," Dr Rashmi said. Dr Sharon ended by speaking about various funding mechanisms available in Scotland. "In Scotland, there are huge expert communities dealing with funding options. There are seed funding, co-investment funding and suitable funding partners. For companies, who want to come into Scotland, we have mechanisms to support them with grants and help them with their expenditure costs and setting up. There is a whole range of funding mechanisms available." Dr Rashmi feels that India is lagging behind in innovation culture. "It (India) is more of generics oriented. It hasn't introduced many innovative medicines, and hence there are revenue discrepancies in the pharma industry. Due to the success of generics, established companies are averse to investing towards long-time innovation. The pharma innovation has about 10 to 15 years of waiting period," he remarked. ]]> <![CDATA[Exploring nanotech touch to phytopharma]]> https://biospectrumindia.com/features/95/7336/exploring-nanotech-touch-to-phytopharma.html https://biospectrumindia.com/features/95/7336/exploring-nanotech-touch-to-phytopharma.html Sat, 18 Jul 2015 08:26:00 +0530 Recent research findings have shown the detrimental effects of common synthetic chemicals used in hygiene and agriculture. In the light of serious health concerns, there is growing demand to adopt eco and earth friendly traditional herbal extracts by refining and fortifying with new technologies to ensure compliant with contemporary product standards. The challenges such as lower bioavailability and higher cost compared to synthetic counterparts have made the traditional phytomaterials suffer from suboptimal efficiencies. Apart from that, the higher costs and volatility due to crude application dosage, lower production yields, adhoc sourcing of this largely unorganised sector too have been the factors that added negativity to it. Now as a ray of light, nanoprocess chemistry has the potential to bring down the dosage levels by improving their efficacies with an impact on cost effectiveness. Working in this direction, the Bangalore based Applied Nanomaterials has been doing research on the nanobio growth stimulators and bio pesticides derived from herbal extracts. The company's progress since its inception in 2012, has been slow and steady. It already offers commercial products and solutions for numerous functions such as eco-friendly nano coatings for UV protection, super hydrophobicity, thermal insulation, lubrication, antifungal and corrosion protection functions. Taking the difficult route Dr Vijay Kunuru, founder and executive director, Applied Nanomaterials has always been passionate about science and later inspired by nanotechnology's potential greener solutions for contemporary pressing issues like global warming, cleaner energy, improving air quality, affordable healthcare and poverty alleviation. After earning his PhD from Cambridge University and completing Post Doctorate research from Cornell University, Dr Kunuru chose to tread the difficult path of becoming an entrepreneur despite green pastures that he came across due to his academic credentials. He is of the firm belief that sustained efforts in a hostile situation too could bring about change. "The global market conditions are favourable for rapid growth of Indian economy especially knowledge intensive manufacturing due to its highly skilled work force and large domestic consumption," Dr Kunuru explained adding further, "It was my conviction that there would be a real need for a company like Applied Nanomaterials to deliver nanotechnology solutions for a wide range of markets. This is in line with my aspiration to take up a career which has larger impact on the society yet involving my first passion for science and technology." Where traditional science meets modern technology The growth of nanotechnology has been gradual against the predicted tangential growth curve partly because it is highly complex and requires intensive capital and skilled human resources. The global economic slowdown has also hampered its research funding and risk capital for commercialisation due to abstract understanding of technology, reactivity, stability and usability combined with largely expensive processes and methods. Despite its sluggish growth, one can find numerous daily use products enabled by nanotechnology such as coatings, photovoltaics, batteries, lubricants, sunscreens, diagnostics, sensors, cancer drugs, LEDs, water filters along with numerous products. "Interestingly India's legacy in nanotechnology and herbal science can be traced back to the ancient times. Avurvedic bhasmas are ancient form of modern nanotechnology. There is huge potential waiting to be untapped in commercializing traditional herbal science benefits with modern assessment and process methods," Dr Kunuru said while sharing his inspiration behind the work he is undertaking. He explains further, "Nanotechnology enables better bioavailability, solubility, interfacial transport by overcoming size barriers for traditional phytochemicals. Owing its nanometric dimensions, it offers efficient membrane transport and higher bioavailability at lower dosages, thus lower toxicity if any. In this context applying nanotechnology methodology to phytomaterials and its derivatives is win-win strategy in terms of better efficacy, economics and environmental sustainability." Talking about the applications, Vijay mentioned, "First foremost the health and medicinal benefits of phytomolecule has been well known for long time, which are human and eco-friendly as compared to the conventional synthetic chemicals. The primary markets are healthcare, nutraceuticals, oral care, plant nutrition and pest protection." Business model based on partnerships The four business verticals of the company include nano-additives, nano-composites, nano-materials and herbal nano-formulations. Currently it offers commercial solutions for UV protection, thermal insulation, water repellence, antimicrobials, disinfectants for markets such as coatings, energy, appliances and personal care segments. It intends to provide nanotech innovative solutions to commercial products in a cost effective way and could act as an effective bridge between academic research innovation and industry in India. The company has collaborated extensively with various stakeholders across the product chain. Currently, it is partnering with conglomerates like Godrej industries, Laursen & Toubro, ACG capsules, and Phytogen pharma in addition to institutes like Indian Institute of Technology, Madras; Indian Institute of Science, Bangalore; Indian Institute of Science, Delhi and State University of New York. It is working with the ACG capsules on capsules auxiliaries pigments and natural colours. Apart from that, it is working with Cipla on porous nano- Silica as drug delivery systems for chemotherapy. With Phytogen Pharma,it is producing herbal based nanobiopesticides, growth stimulators and disinfectants. The company is actively pursuing synergy opportunities on joint product development with Cipla, Dow and Israel chemicals for numerous products. "We have numerous technologies under pipeline and ready to be commercialised for lubrication, refrigeration, smart coatings and packaging. Now, we are entering into the area of herbal extracts and phytomaterials, which can revolutionise agriculture and primarily health care space. Therefore, the company's future prospects are extremely bright," concludes Dr Kunuru. The unclear regulations and validation through clinical trials further contribute to the delay in the growth of nanotechnology in advance medicine and healthcare. Developing countries like India have all favourable conditions and opportunity to invest in the risk capital to develop cost effective nanotechnology solutions. So the need of the hour is that along with "Make in India" we should also focus on "Innovate in India" Hard Talk: Sharing his thoughts on innovation, Dr Kunuru opined, "I have found that Indian manufacturing landscape was operating under a highly fragmented environment and a wide gap exists between industry and academia in terms of knowledge, perspective and philosophy, which doesn't promote indigenous innovations in the current setting. It would be unsustainable for an economy like India not only its sheer size and consumption but its aspiration to become an emerging leader in a global scenario." ]]> <![CDATA[Tergene Biotech develops vaccine for pneumonia]]> https://biospectrumindia.com/news/95/6149/tergene-biotech-develops-vaccine-for-pneumonia.html https://biospectrumindia.com/news/95/6149/tergene-biotech-develops-vaccine-for-pneumonia.html Fri, 17 Jul 2015 15:36:00 +0530 Singapore: Tergene Biotech, an Indian start up, has developed a promising vaccine candidate to combat pneumonia. The vaccine is targeted against specific types of bacteria that cause pneumonia in India, South Asia and Africa. Founded by Mr M Kuppusamy, a biotechnologist and veteran in the vaccine industry, Tergene is deploying novel vaccine technology to cut time and cost and make the vaccine affordable. Current vaccines are priced at Rs 3,500 per dose and the immunization program involves three doses. This makes the vaccine highly inaccessible to low income groups. "The vaccine will probably hit the market in the next 2-3 years. The existing vaccines are tailored to help prevent pneumonia caused by serotypes (there are 90 identified so far) of bacteria in the western nations", said Ms Pushpa Vijayaraghavan, vice-president of Sathguru Management, which has helped Tergene through its journey of developing the vaccine and setting up facilities. Earlier this year, India's leading drugmaker Aurobindo Pharma had announced a joint venture with Tergene to develop the pneumonia vaccine candidate. As per the deal, Aurobindo will have a majority stake in the JV and will fund the product development in a phased manner spanning over three years. ]]> <![CDATA[Apotex recalls its drug in the US]]> https://biospectrumindia.com/news/95/8181/apotex-recalls-its-drug-in-the-us.html https://biospectrumindia.com/news/95/8181/apotex-recalls-its-drug-in-the-us.html Fri, 17 Jul 2015 13:07:18 +0530 Apotex is recalling 91,962 bottles of Losartan potassium tablets in the US, due to "failed content uniformity specifications." The drugs were manufactured by the company's Indian arm Apotex Research Pvt Ltd. It has been classified as a class-II recall which FDA defined as "a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote." ]]> <![CDATA[NATHEALTH pledges support for Digital India campaign ]]> https://biospectrumindia.com/news/95/6043/nathealth-pledges-support-for-digital-india-campaign-.html https://biospectrumindia.com/news/95/6043/nathealth-pledges-support-for-digital-india-campaign-.html Fri, 17 Jul 2015 13:06:19 +0530 The Digital India campaign launched by the union government is growing stronger by the day. NATHEALTH has joined the industry associations that have lended support to this initiative. Commenting on it, Mr Sushobhan Dasgupta, president, NATHEALTH mentioned, PM's efforts to transform India into a connected knowledge economy and offering world class services at the click of a mouse through Digital India programme, is truly commendable. Initiative of using mobile and internet strategies - such as telemedicine, doctors on call and remote patient monitoring will help in improving the access of quality healthcare universally. Mr Dasgupta also added that Telemedicine through Tele-Consultation, E-ICUs, remote patient monitoring, lifestyle management through education tools will further help in enhancing patient care to the next level. Through digital mode, a patient at the primary health center in a village can be connected to any medical specialist hundreds of miles away and diagnosed online. It can also be a powerful tool for real time disease surveillance which is needed to fight the risk of epidemics such as Non Communicable Diseases, Tuberculosis, Trachoma, Leprosy, Malaria. Mr Anjan Bose, secretary general NATHEALTH said, using wearable and mobile technology will help educate and engage citizens in healthy living and prevention of diseases. India has Mobile Penetration increasing at 3 percent, Smartphones at 70 percent and internet at 22 percent. Innovations in 'Digital Healthcare' will enable solutions across the healthcare value chain. Mr Bose added, "Through our collaboration MoU with NASSCOM, our vision is to leverage technology to address healthcare challenges, in order to improve patient care. NATHEALTH-NASSCOM joint initiative will try to build linkages across multiple stake-holders in healthcare and information technology sectors. We will try to evangelize a new class of technology solutions and service delivery platforms that enhance healthcare access, affordability, availability and therefore support the government's aim to achieve "Universal Health Coverage". NATHEALTH and NASSCOM have formed a Joint Council (NNJC), comprising of top leaders in member companies from both the institutions, representing respectively Healthcare and IT sectors. The Joint Council will focus on (1) Creation of Central IT Healthcare Platform, (2) Remote Healthcare, (3) IT Enabled Preventive and Chronic Care and (4) Healthcare Workforce. We aim to leverage digital technology for innovative solutions which will help both Healthcare and IT sectors grow further. Emerging technologies like cloud, analytics, pervasive presence of mobile telephony and broadband penetration has created new opportunities for both healthcare and technology sectors to collaborate and increase Healthcare quality, accessibility and affordability, informed Mr. Bose. As Digital India is an umbrella programme including several schemes for inclusive growth in multiple sectors through digitalization of services, it would help us to create self-sustaining models in healthcare that will enable the rapid growth of the services, by creation of digital infrastructure and service delivery through digital mode, added Mr. Dasgupta. ]]> <![CDATA[Mankind Pharma to have US presence; expects revenue of $150 mn]]> https://biospectrumindia.com/news/95/6693/mankind-pharma-to-have-us-presence-expects-revenue-of-150-mn.html https://biospectrumindia.com/news/95/6693/mankind-pharma-to-have-us-presence-expects-revenue-of-150-mn.html Thu, 16 Jul 2015 16:39:00 +0530 Mankind Pharma, one of the largest and fastest growing pharmaceutical companies is on an aggressive growth path to achieve domestic revenue of Rs. 5000 crore from Rs. 3,400 crore by the end of 2016. Moving ahead on the expansion spree, the company is also looking to enhance its presence in the US in the next 18 months while expecting revenue generation of $150 million from the International market by 2030. The firm is planning investment of Rs. 150 crores in the manufacturing unit at Paonta Sahib in Himachal Pradesh. Keeping an eye on the future growth drivers and to place itself among the top three pharmaceutical companies of India, its focus is on chronic segments, nutraceuticals, cosmetology and newer markets to attract global business. The company is also planning to launch patented drugs of multinational pharma companies in the Indian market and has started exporting its products to developing markets, including Asia & Africa. It has witnessed an average growth of 20-25 per cent for the past five years. In a recent market reflection report by the IMS Health ranked Mankind Pharma 4th in the Indian Pharmaceutical Market with 18% growth and monthly sales of Rs. 240 crores. Mr. R C Juneja, Chairman and Founder, Mankind Pharma, commenting on the achievement said, "With an inverted business model, innovation and continuous research and development, we have successfully achieved the prestigious reward. We are identifying overseas markets, have entered new segments and are strengthening ourselves in the cardiovascular and anti-diabetic drug categories. The API factory that we are coming up would focus on enabling the company to make cheaper drugs. The API facility is a step to promote affordable drug manufacturing in India where a third of the population has no access to medicines." With an annual growth of 18%, Mankind Pharma has an annual turnover of Rs. 3,400 crore in the fiscal year 2014-2015 up from Rs 4 crore in fiscal Year 1995-96. In the last 10 years, Mankind has grown at an average of 30%, against an industry average of 12%. Presently the company has an employee base of more than 12,000 with one medical representative for every 200 doctors in the country. In regards to the present scenario, the company has over 1,000 brands spanning medicines categories such as antibiotics, antifungals, gastro intestinal, cardio vascular dermals and etc. As per the industry estimate, the cardiac segment has grown 26% and so have anti- diabetic and VMS (vitamins, minerals, supplements) categories, by 24% and 23% respectively. Mankind's focus on 'dermatological products' has resulted in its entry into the Top 10 category's with a value of Rs. 135 crore and a growth of 40%. ]]> <![CDATA[Pfizer India is closing its manufacturing plant in Thane]]> https://biospectrumindia.com/news/95/5284/pfizer-india-is-closing-its-manufacturing-plant-in-thane.html https://biospectrumindia.com/news/95/5284/pfizer-india-is-closing-its-manufacturing-plant-in-thane.html Thu, 16 Jul 2015 15:48:00 +0530 The multinational pharmaceutical firm, Pfizer Ltd, will be closing its 50 year old manufacturing facility in Thane district on 16 September 2015. The plant was inactive or was not manufacturing any of its products here for last 2 years. All the production was diverted to contract manufacturing or into its Goa manufacturing facility. The plant had disputes with its employee organization namely 'Pfizer employee union' resulted in halting the operations. This plant was commissioned in the 1960s and has been a part of Pfizer India's heritage for over 50 years. During this time, it has served millions of patients, producing a number of medicines for both domestic and international markets. The company with a turnover of Rs 1004.27 crores for last year, is employing more 4000 people across India. Pfizer in India have its popular brands like COREX (Cough Formulation) and Becosules (Multivitamin) and Gelusil. The announcement reads "the Company has intimated the concerned authorities that it intends to effect closure of its plant situated at Turbe, Thane Belapur Road, K.U. Bazar P.O., Navi Mumbai ("the Plant") with effect from September 16, 2015. The decision to close the Plant is based on an assessment of its long term viability and its ability to achieve the needed production. There has practically been no production activity at this plant since 2013, and the closure will not impact the supply of any of the Company's medicines to patients." Pfizer spokesperson said "The Company had offered a generous voluntary retirement scheme (VRS) to the workmen at this site last year, upon their request. This was taken up by as many as 132 of the 212 workmen. The remaining 80 workmen have continued to receive full wages, despite plant inactivity. As a part of the closure process, the Company will honour its obligations towards requisite compensation, as mandated by law, for the remaining workmen. We are grateful for the contribution of the workmen and colleagues and will ensure that they are treated with fairness and respect. Pfizer remains committed to providing high quality medicines to our patients and customers in India." ]]> <![CDATA[Syngene IPO price band at Rs 240-250]]> https://biospectrumindia.com/news/95/4564/syngene-ipo-price-band-at-rs-240-250.html https://biospectrumindia.com/news/95/4564/syngene-ipo-price-band-at-rs-240-250.html Thu, 16 Jul 2015 11:34:00 +0530 Bangalore based Biocon Ltd has fixed a price band for an initial public offering (IPO) of its subsidiary Syngene International Ltd at Rs.240-250 per equity share. The offer shall open for subscription on 27 July and close on 29 July. The company informed stock exchanges. Biocon said that the red herring prospectus filed by Syngene with the Registrar of Companies, Bengaluru was approved on 15 July. Syngene is planning to sell 2.2 crore equity shares, including up to 20 lakh reserved shares for Biocon shareholders, through an offer for sale. In earlier statements, biocon had said that the proceedings from the IPO will be used for R&D activity in setting up a new manufacturing facility, a centre for work on biologics and formulations in Bengaluru ]]> <![CDATA[GSK inks pact with Francis Crick Institute ]]> https://biospectrumindia.com/news/95/7302/gsk-inks-pact-with-francis-crick-institute-.html https://biospectrumindia.com/news/95/7302/gsk-inks-pact-with-francis-crick-institute-.html Thu, 16 Jul 2015 11:16:28 +0530 The Francis Crick Institute and GSK are to partner on an open innovation collaboration exploring new avenues of medical research and drug discovery across a broad range of diseases, with a view to achieving breakthroughs in the understanding of human disease. This is the first collaboration to be established between the Crick and a pharmaceutical company. Teams of scientists from each organisation will work side-by-side in integrated teams at the Crick's world-leading centre of biomedical research in the heart of London and GSK's global R&D hub in Stevenage. GSK and the Crick believe that this fluid interchange of skills and ideas could lead to significant discoveries in the basic scientific understanding of human disease, which could ultimately improve the success rate for discovering new medicines. The GSK-Crick open science collaboration will combine the specialised disease biology knowledge of the Crick's scientists with the pharmaceutical R&D expertise of GSK scientists, opening up possibilities for scientific discovery that would not be possible for each partner working alone. Together, these world-leading researchers will conduct biological research projects focused on learning more about how diseases take hold in the body and how they could best be treated, which in turn is expected to result in increased efficiency and reduced attrition in R&D. Mr David Roblin, chief operating officer and director of Scientific Translation at the Francis Crick Institute, said, "This truly represents a landmark agreement in open science. In the Crick we aim to have industrial scientists embedded in our laboratories and fully integrated with our existing scientific groups. Together the scientists will accelerate breakthroughs in the understanding of human health and disease. GSK is an outstanding partner to commence this effort and I am excited to see what we deliver together." GSK's president of pharmaceuticals R&D, Mr Patrick Vallance, said, "As a company with deep research roots in the UK, we're enormously proud of this country's vibrant biosciences community and the cutting-edge biomedical research that takes place here. That's why we continue to invest a quarter of our R&D spend in the UK and have collaborations in place with some of the country's top research institutions, which rank among the best in the world." GSK and the Crick will contribute in-kind resources, including lab space and the scientific expertise of 20 staff to the collaboration. GSK will also provide important research tools to the collaboration, including access to its non-development compound library, key antibodies, reagents and technologies, which will be used to address key questions in disease biology. A number of projects within this collaboration exploring diseases including HIV, malaria and cancer are expected to start in 2015. This will build up to a steady state of 10-15 projects in 2016. The ongoing nature of the Crick-GSK collaboration is expected to foster strong links between the organisations, as well as providing an excellent channel for the training and development of talented staff. ]]> <![CDATA[Delhi set to host healthcare innovators summit in August]]> https://biospectrumindia.com/news/95/5970/delhi-set-to-host-healthcare-innovators-summit-in-august.html https://biospectrumindia.com/news/95/5970/delhi-set-to-host-healthcare-innovators-summit-in-august.html Thu, 16 Jul 2015 11:12:00 +0530 Patients in India and across the globe struggle to access quality healthcare, even as providers strive to improve delivery. To address these challenges, HITLAB®, a healthcare innovation and teaching lab, based out of New York City and New Delhi, is hosting the HITLAB Innovators SummitSM, India. Sponsored by MEDTRONIC, the event will be held on 7th August at the Department of Management Studies, Indian Institute of Technology, Delhi, India. HITLAB works with leading organizations across the globe to ideate, create, and evaluate solutions that improve healthcare quality and accessibility. The HITLAB Innovators Summit, India will gather leaders in public health, medicine, technology, and design to discuss health issues and solutions in a live event. The Summit will feature a series of carefully curated talks, panels, and collaboration opportunities designed to engage the most creative minds in health and technology. A wide variety of healthcare stakeholders will be present, including medical device companies, non-profit foundations, startups, and venture capitalists. The HITLAB Innovators Summit culminates in the HITLAB World Cupâ„ , India 2015, a challenge of unparalleled diversity where innovators will present original solutions to pressing global healthcare issues, creating technologies and products in an effort to improve public health. Teams from countries such as India, Malaysia, Nigeria, Kenya, Spain, Portugal, Spain, Uzbekistan, the United Kingdom, and the United States have previously participated. This year, close to 25 Indian startup applicants will be selected by HITLAB and its collaborator HealthStart, India for detailed discussions with global venture funds and individual investors. Out of them, Up to 12 Indian startup will get chance to present their ideas at HITLAB Innovators Summit India 2015 and Upto 5 winners be chosen for seed funding. HITLAB World Cup and HealthStart, India have formed a unique partnership aimed at providing promising healthcare innovations in India on a global diffusion platform. Up to five finalists will provided with seed funding. Key Summit Highlights: 1. The HITLAB Innovators Summit, India 2015 will take place on 7th August at the Department of Management Studies, Indian Institute of Technology, Delhi, India. 2. Speakers will include experts from New York, Boston, and India. 3. Organizations confirmed to attend include medical, for-profit, and non-profit companies including Medtronic, Robert Bosch Engineering Centre, National Institute of Health & Family Welfare, Actavis (New York), Somerset Indus Capital Partners, SAIF Ventures, IDG Ventures, and HealthStart, India. More are added every day. 4. Startups specializing in innovative healthcare technologies are urged to participate in the HITLAB World Cup. 5. Up to five finalists will be chosen; 20 lakh seed funding will be provided to each startup. The HITLAB Innovators Summit 2015 is an exciting opportunity to impact healthcare for the better, providing solutions to improve healthcare access and delivery in India and throughout the world. ]]> <![CDATA[Vanderbilt University joins Human Vaccines Project as first scientific hub]]> https://biospectrumindia.com/news/95/4371/vanderbilt-university-joins-human-vaccines-project-as-first-scientific-hub.html https://biospectrumindia.com/news/95/4371/vanderbilt-university-joins-human-vaccines-project-as-first-scientific-hub.html Thu, 16 Jul 2015 09:55:12 +0530 Vanderbilt University Medical Center (VUMC), the Human Vaccines Project, and the International AIDS Vaccine Initiative (IAVI) have announced that VUMC has become the Project's first scientific hub. Incubated by IAVI, the Human Vaccines Project is a new public-private partnership that brings together leading academic research centers, industry, governments and nonprofits to accelerate the development of vaccines and immunotherapies against infectious diseases and cancers by decoding the human immune system. "We are delighted that Vanderbilt University Medical Center will bring its world-class vaccine research and human immunology expertise to the Human Vaccines Project," said Wayne C. Koff, IAVI Chief Scientific Officer and the Project's Founder. Under the collaboration, VUMC has pledged a multi-year commitment toward the Project which will include a large-scale global effort to decipher the "Human Immunome," the basic components of the human immune system, to enhance design of next-generation vaccines and immunotherapies. "We are pleased to be the Project's flagship scientific partner. Vanderbilt's longstanding commitment to vaccine research and development will allow us to make valuable contributions toward accelerating the creation of new vaccines and therapies necessary to fight significant diseases," said Jeff Balser, M.D. Ph.D., Vanderbilt University's Vice Chancellor for Health Affairs and Dean of the School of Medicine. The Human Vaccines Project has been incubating over the last year at IAVI, as part of IAVI's commitment to pursuing innovative approaches to accelerate HIV vaccine development. Going forward, VUMC will become the first of several scientific hubs located at leading global academic research centers that will carry out the Human Vaccines Project's Scientific Plan under long-term collaborations. "IAVI has been proud to incubate this exciting project with catalytic support from the Robert Wood Johnson Foundation and GSK. It has great potential to advance efforts to develop safe and effective vaccines for HIV as well as other global health priorities," said IAVI CEO Margie McGlynn. Over the last five years, new technologies including genomics, systems biology and bioinformatics have revolutionized human immune monitoring capabilities and offer the potential to transform vaccine and immunotherapy development and, in doing so, change the face of global disease prevention and control. "Vaccine and immunotherapy development is entering a new era, and large scale global research efforts such as the Human Vaccines Project linking industry and academia offer the potential to greatly impact human health," said Moncef Slaoui, IAVI Board Member and Chairman, Global Vaccines, GlaxoSmithKline. ]]> <![CDATA[Sanofi launches initiative to spread awareness on Influenza prevention]]> https://biospectrumindia.com/news/95/4341/sanofi-launches-initiative-to-spread-awareness-on-influenza-prevention.html https://biospectrumindia.com/news/95/4341/sanofi-launches-initiative-to-spread-awareness-on-influenza-prevention.html Thu, 16 Jul 2015 09:54:21 +0530 Sanofi Pasteur, the vaccines division of Sanofi, has announced an initiative to educate parents in India about the seriousness of influenza (also known as flu) and preventing it amongst young children. Considering the grave impact of the disease across India in the beginning of 2015, renowned actor, director, singer, and father - Farhan Akhtar - has chosen to spread awareness about flu prevention. Farhan's messages will reach people via mass media and in-clinic as well. Speaking about the initiative, Jean-Pierre Baylet, Country Head - Sanofi Pasteur India, said, "Influenza is a serious and contagious disease that often gets mistaken for common cold. As seen during the early part of the year, influenza outbreaks can cause significant morbidity and mortality and strain the health care system. According to the WHO, the principal way of reducing Influenza burden is by vaccination. However lack of awareness is a limiting factor in vaccine usage. Sanofi Pasteur, India is therefore embarking on an initiative to educate the masses and improve awareness on Influenza and its prevention. We are delighted that Farhan Akhtar is supporting the cause of flu prevention to ignite attitudinal change towards influenza and its prevention." Regarding his decision to support the cause, Farhan Akhtar said, "I was shocked to see the impact that flu has had across India in the last few months. As a parent, I was concerned for my children's welfare and hence, consulted their pediatrician. It was surprising to learn that flu is not a common cold, but a serious viral infection that carries a high risk especially amongst children below the age of 5. It was reassuring to know that flu can be prevented and children can be protected against flu through timely vaccination. This was a revelation to me, and I am sure that there are others too who have misconceptions about the disease, inadvertently risking their children's lives. Hence, in my capacity as a public figure, I decided to support the initiative to spread the message on flu prevention." Mr Arun Wadhwa, Senior Paediatric Consultant, South Delhi "It is very important for everyone and especially for higher risk groups such as children and senior citizens to get the annual flu shot. Vaccination protects not only against severe flu but also related complications such as pneumonia that can even lead to death. However, in India this is not common knowledge and so flu danger is taken lightly. Only in times when flu is prevalent, people take action. This is an unsafe practice and we need to change this mindset." According to the World Health Organization (WHO), vaccination against influenza is currently the principal means of reducing or counteracting influenza mortality and reducing the morbidity burden in the country. The World Health Organization (WHO) has declared seasonal influenza a serious public health problem. Each year, influenza affects 5-15 percent of the global population but the rates can reach 40% - 50 percent in high risk groups. In India, millions are increasingly exposed to influenza and its life threatening health complications. During the recent outbreak in the beginning of 2015, the virus affected approximately 33,000 people, killing nearly 2000 plus people. Since 2011, under its corporate initiative, 'I for Immunisation', Sanofi Pasteur India has conducted various awareness drives, such as launching a Facebook page called 'Mothers against flu. ]]> <![CDATA[SC tells govt to relook at drug pricing policy]]> https://biospectrumindia.com/news/95/4275/sc-tells-govt-to-relook-at-drug-pricing-policy.html https://biospectrumindia.com/news/95/4275/sc-tells-govt-to-relook-at-drug-pricing-policy.html Thu, 16 Jul 2015 09:53:02 +0530 The Supreme Court has asked the government to revisit its new National Pharmaceutical Pricing Policy, 2012, for fixing prices of essential medicines in the country and also the Drugs Order, 2013, notified by the government in May 2013. "The Centre's drug pricing policy seems to be unreasonable and irrational for fixing prices at the very high level", a three judge Bench, headed by Justice TS Thakur, said. The Bench, which also comprised Justices V Gopala Gowda and R Banumathi, asked the Department of Pharmaceuticals under the Union Ministry of Chemicals and Fertilisers to pass a reasoned order on the representation of NGO, All India Drug Action Network, on the issue within six months after hearing all parties concerned. ]]> <![CDATA[Price control has failed to improve access to medicines: IMS Health report]]> https://biospectrumindia.com/news/95/6127/price-control-has-failed-to-improve-access-to-medicines-ims-health-report.html https://biospectrumindia.com/news/95/6127/price-control-has-failed-to-improve-access-to-medicines-ims-health-report.html Wed, 15 Jul 2015 11:54:34 +0530 As per the study, 'Assessing the Impact of Price Control Measures on Access to Medicines in India', such a strategy is ineffective and can be counter productive as well. The price control is neither an effective nor sustainable strategy for improving access to medicines for Indian patients, says the report. The report suggests a combination of healthcare financing and non-financing measures such as promoting joint and bulk procurement mechanisms and investment in capacity building be adopted by the government to address the issues of access and affordability. Noted economist and author, Dr Surjit Bhalla who released the report remarked, "In my experience, the poor are the last to benefit from price control interventions. Not surprisingly, this study shows that high-income patient populationss have been the main beneficiaries of DPCO 2013. In addition to price control, tariffs on essential medicines completely defeat the goal of making such medicines available to low income patients." Commenting on the findings of the report, IMS Health South Asia General Manager Nitin Goel said: "Price control has limited impact on improving patient access and, furthermore, is not aligned with the requirements of a vibrant economy like India." Government's priority should be on strengthening India's healthcare infrastructure and extending universal insurance coverage, he added. Following the publication of the Drug Price Control Order (DPCO) 2013, more than 652 formulations in India are now subjected to a price ceiling in an effort by the government to maintain affordability and increase access to drugs. Highlighting some of the unintended results of the DPCO 2013, the report said primary beneficiaries of its price controls have been high income patient populations, rather than the low-income targets. It also revealed that consumption of price-controlled drugs in rural areas has decreased by 7 percent over the past two years, while that of non-price controlled products has risen by 5 percent. While speaking to the BioSpectrum, Mr DG Shah, secretary general of the Indian Pharmaceutical Alliance (IPA) termed the price control measures as artificial thrreby introducing distortions in the pharma industry. "Our repeated suggestions on price control strategy to the successive governments have so far not taken into consideration for the reasons best known to them." Price control has also increased margin pressures for small and mid-sized companies, limiting both employment and investment opportunities in the sector, the report said. Emphasising that price control measures have failed in other countries too, the report said: "These conclusions are corroborated by similar outcomes in China, the Philippines and South Korea, where price controls have consistently failed to improve overall access to medicines." ]]> <![CDATA[Biofertilizers market to report strong CAGR of 13% through 2019 ]]> https://biospectrumindia.com/features/95/5893/biofertilizers-market-to-report-strong-cagr-of-13-through-2019-.html https://biospectrumindia.com/features/95/5893/biofertilizers-market-to-report-strong-cagr-of-13-through-2019-.html Wed, 15 Jul 2015 10:46:53 +0530 The exponential growth reported by the organic food industry, coupled with the environmental hazards linked to chemical fertilizers, will turn the focus on biofertilizers in the future, says a latest report by Transparency Market Research. According to the report titled "Biofertilizers Market - Global Industry Analysis, Size, Share, Growth, Trends and Forecast, 2013 - 2019," the global biofertilizers market approximated $440.0 million in 2012, and will rise considerably to $1,028.7 million by 2019, reporting a 13.0 percent CAGR between 2013 and 2019. The key market drivers, according to the report, are: Robust growth of the organic food market, government funding and support toward encouraging the production and use of biofertilizers, and heightened awareness about the detrimental effects of chemical fertilizers on the environment. Consumers, on the other hand, are now reading product labels more carefully than ever before and show a greater inclination toward chemical- and synthetic-ingredient-free products. All of these factors augur well for the greater adoption of bio-based plant treatment. However, the adoption of biofertilizers hasn't caught on consistently throughout the world yet. And, as evidenced by recent studies, certain biofertilizers reportedly have sedative effects. These two factors will impede the growth of the global biofertilizers market, the report states. Commenting on the opportunities that exist in the biofertilizers market, a TMR analyst said, "Massive opportunities for biofertilizers are seen in rapidly-emerging economies such as China and other large, developing countries where agriculture still forms an appreciable part of the economy." As per the report's findings, nitrogen fixing biofertilizers accounted for the predominant share (78 percent) of the global demand as of 2012. These fertilizers are much sought-after thanks to their ability to boost nutrient supply in an ecologically sound manner, supplemented by an increase in the demand for both leguminous and non-leguminous plant products. Moving forward, phosphate solubilizing biofertilizers will post the fastest rate of growth as they are growingly preferred due to their multifunctional attributes, cost-effectiveness, and eco-friendliness as a bio control agent. TMR's analysts also studied the global biofertilizers market on the basis of applications. Their findings show that in 2012, seed treatment was the largest application segment, and was worth $316.5 million. Farmers are now compelled to move toward more eco-friendly seed treatment options because of increasing government restrictions in a bid to cut back on the use of chemicals-based pesticides. At the same time, market researchers observe that bio-based soil treatments will also witness an upswing in demand due to the aforementioned factor. Consequently, the soil treatment segment will report significant growth over the report's forecast horizon. From the geographical standpoint, North America prevailed as the predominant biofertilizers market in 2012, and was trailed by the Rest of the World (RoW) region. This upward growth graph is a result of the palpably higher demand for organic food products. Over the remainder of the report's forecast period, the Asia-Pacific region will exhibit the highest growth rate in the biofertilizers market thanks to heightened consumer awareness about the ill-effects of synthetic fertilizers. This switchover is being actively supported by government agencies. In Asia Pacific, the demand for biofertilizers will report a CAGR of 13.3 percent from 2013 through 2019. The global biofertilizers market report profiles leading participants such as: Agri Life, Gujarat State Fertilizers and Chemical, Antibiotice S.A, Lallemand, Novozymes, National Fertilizers, Madras Fertilizers, and Symborg S.L. ]]> <![CDATA[WHO to accelerate national and global health security]]> https://biospectrumindia.com/news/95/5792/who-to-accelerate-national-and-global-health-security.html https://biospectrumindia.com/news/95/5792/who-to-accelerate-national-and-global-health-security.html Tue, 14 Jul 2015 17:44:50 +0530 The World Health Organization (WHO) has brought together 200 high-level experts from governments, development agencies, civil society and international organizations to make the world a safer place. The conference called "Building Health Security Beyond Ebola" is held in Cape Town, South Africa, from 13 to 15 July. Experts at the meeting will focus on how to make countries and communities stronger by accelerating development of health systems and capacities identified by the International Health Regulations (IHR) (2005) to prevent, detect and respond to a public health emergency of international concern. All WHO Member States have accepted the IHR as the internationally agreed foundation to build global health security. Dr David Nabarro, Secretary-General's Special Envoy on Ebola, who helped open the conference emphasized the importance of stopping outbreaks before they become catastrophic. Other key messages were delivered by Ms Malebona Precious Matsoso, Director General of the National Department of Health, Republic of South Africa, Dr Keiji Fukuda, Assistant Director-General, WHO, Dr Matshidiso Moeti, WHO Regional Director for Africa (via video), H.E. Ambassador Olawale Maiyegun, African Union, Dr PÃ¤ivi Sillanaukee, Permanent Secretary, Ministry of Social Affairs and Health, Finland, and Ambassador Bonnie Jenkins, U.S. Department of State. Public health emergencies of international concern, including the Ebola virus disease (EVD) epidemic in West Africa, have demonstrated the need for countries to be prepared and have the capacity to rapidly respond to outbreaks and emergencies to maintain national and global health security. "Transborder, transnational and intercontinental cooperation remains a high priority for WHO considering the frequency and magnitude of health crises before us. To prepare and respond to these crises, we have no margin for error and timing is essential," said Dr Matshidiso Moeti, WHO Regional Director for Africa. Progress has been made in strengthening public health capacities to manage disease outbreaks; however, gaps in core capacities and funding remain major impediments and require renewed commitment from national governments with support from the international community. The meeting aims to intensify coordination among stakeholders to strengthen the capacities, systems, and services needed to detect, report and respond to serious public health events. WHO proposes that, at a minimum, the initial phase of intensified preparedness focus on ensuring that all countries in Africa have the following capacities firmly in place on a functional and sustainable basis: â€¢ A surveillance system that will cover the country from community to national levels and be adapted to relevant conditions, and which will use well-trained staff and proven information management systems; â€¢ A central national emergency operation centre with capacities and resources to function as a central hub for national surveillance at all times, and as the central operational hub to be activated during health emergencies; â€¢ Sustainable community engagement and risk communication strategies and resourced plans; and â€¢ Critical laboratory diagnostic capacities with associated quality assessment processes. Experts from United Nations agencies, African Union Commission, Southern African Development Community (SADC), International Organization for Migration (IOM), MÃ©decins Sans FrontiÃ¨res (MSF), World Bank, Bill and Melinda Gates Foundation, and U.S. Centers for Disease Control and Prevention, among others are participating in the 3-day meeting. The meeting is hosted by the National Department of Health, South Africa. ]]> <![CDATA[Suven Life Sciences secures three product patents]]> https://biospectrumindia.com/news/95/7679/suven-life-sciences-secures-three-product-patents.html https://biospectrumindia.com/news/95/7679/suven-life-sciences-secures-three-product-patents.html Tue, 14 Jul 2015 12:30:33 +0530 Suven Life Sciences (Suven) has announced that they have secured patents in China (CN103443093) and South Africa (2013/01143, 2013/06328) to their New Chemical Entities (NCE's) for CNS therapy through mechanism of action - H3 Inverse agonist and these patents are valid until 2031,2030 and 2031 respectively. The granted claims of the patent include the class of selective H3 ligands discovered by Suven and are being developed as therapeutic agents and are useful in the treatment of cognitive impairment associated with neurodegenerative disorders. Suven also secured a patent for their NCE in Mexico (326651) and the granted claims of this patent include the class of selective alpha-4-beta-2 compounds discovered by Suven and are being developed as therapeutic agents for major depressive disorder (MDD) and the patent is valid through 2030. With these new patents, the company has a total of sixteen (16) granted patents from China, nineteen (19) granted patents from Mexico and twenty two (22) granted patents from South Africa. "We are very pleased by the grant of these patents to Suven for our pipeline of molecules in CNS arena that are being developed for cognitive disorders with high unmet medical need with huge market potential globally," said Mr Venkat Jasti, CEO of Suven. ]]> <![CDATA[Dr Reddy's launches a new generic drug in the US]]> https://biospectrumindia.com/news/95/6604/dr-reddys-launches-a-new-generic-drug-in-the-us.html https://biospectrumindia.com/news/95/6604/dr-reddys-launches-a-new-generic-drug-in-the-us.html Tue, 14 Jul 2015 11:50:20 +0530 Dr Reddy's Laboratories has announced that it has launched Memantine hydrochloride tablets USP, 5 mg and 10 mg, a therapeutic equivalent generic version of NAMENDA (memantine HCl)tablets in the US market. The NAMENDA (memantine HCl) tablets brand had the US sales of approximately $1.4 billion MAT for the most recent twelve months ending in May 2015, according to IMS Health. The company's Memantine hydrochloride tablets USP, 5 mg is available in bottle count size of 60 and the Memantine hydrochloride tablets USP, 10 mg are available in bottle count sizes of 60 and 500. ]]> <![CDATA[FDA nod to Aurobindo's new drug]]> https://biospectrumindia.com/news/95/5203/fda-nod-to-aurobindos-new-drug.html https://biospectrumindia.com/news/95/5203/fda-nod-to-aurobindos-new-drug.html Mon, 13 Jul 2015 10:37:00 +0530 Aurobindo Pharma has announced that the company has received final approval from the US Food and Drug Administration (US FDA) to manufacture and market Flecainide Acetate Tablets USP 50 mg, 100 mg and 150 mg (ANDA 202821). The company will commence shipping shortly. The approved ANDA is bioequivalent and therapeutically equivalent to the reference listed drug product (RLD) Tambocor Tablets, 50 mg, 100 mg, 150 mg. Flecainide Acetate Tablets are an antiarrhythmic agent with an estimated market size of $61 million for the twelve months ending April 2015, according to IMS. This is the 40th ANDA to be approved out of Unit VII formulation facility in Hyderabad, for manufacturing Oral Non-betalactam products, said the company. ]]> <![CDATA[National Committe reviews ethical and legal perspectives of healthcare ]]> https://biospectrumindia.com/news/95/5108/national-committe-reviews-ethical-and-legal-perspectives-of-healthcare-.html https://biospectrumindia.com/news/95/5108/national-committe-reviews-ethical-and-legal-perspectives-of-healthcare-.html Mon, 13 Jul 2015 10:32:32 +0530 The committee, consisting of all major medical and hospital societies in the country, led by the Association of Healthcare Providers India (AHPI) and the Indian Medical Association (IMA), discussed the present scenario among the medical fraternity, and has representation from the Association of National Board Accredited Institutions (ANBAI), Christian Coalition for Health India (CCHI), Consortium of Accredited Healthcare Organizations (CAHO), Academy of Hospital Administration (AHA), All India Ophthalmological Society (AIOS), Association of Otolaryngologists of India (AOI), Association of Physicians India (API), Association of Surgeons of India (ASI), Medical Officers Association of ESIC, Federation of Obstetrics and Gynecological Societies of India (FOGSI), Indian Academy of Pediatrics (IAP), Indian Orthopedic Association (IOA), Indian Society of Anesthesiologists (ISA), and Indian Radiological and Imaging Association (IRIA). All these major societies will liaise with their subspecialty associations so that the entire medical community will be involved in this important exercise. It was reiterated that the patient is the focus, and as health professionals all effort should be made to ensure provision of quality, ethical, easily accessible and affordable care to all. This would include standardization of care with minimum levels as appropriate. Communication to and with patients, and their relative and attendees was one area, which needed improvement. Unethical practices, like taking and giving of commissions etc. are not acceptable, and also are cause for increased cost of healthcare. Recent awards of huge amounts as compensation for medical negligence have been making the news. Members noted that these verdicts have resulted in a huge increase in the number of cases filed against doctors, as well as a significant increase in the premiums paid to insurance companies. Unfortunately, this results in more expensive medical care, which is borne by the patient as is evident from the experience in US and other developed countries. In addition, hospitals and doctors are now reluctant to take on complicated cases for fear of medico-legal issues, and many have stopped practice. In India, this only adds to the already severe shortage of specialists. Again, it is the patient who suffers, deprived of adequate medical care of an acceptable standard. Another recognized factor for increased cost in these situations is practice of defensive medicine, an example of which is getting excessive investigations done by the clinician for fear of being questioned in the court of law. One solution discussed by the committee was that it may be desirable to place a cap on the amount that can be awarded in cases of medical negligence, as practiced in countries such as the US. Dr Marthandam Pillai, president, IMA, noted that the capping could be a reasonable and balanced solution to the problem by placing a limit on the amount that can be awarded against a hospital or doctor by any court. He added, "The current type of award for medical negligence is unsustainable and puts a lot of pressure on doctors. Putting a cap on compensation could act as a deterrent and remind the medical fraternity of the consequences of medical negligence but without hampering their daily practice, as is currently the case." Dr Devi Shetty said that the 80 percent of hospital births in India are in hospitals or nursing homes which have 30 or less beds. He added, "These smaller health care facilities in rural and semi-urban areas which provide care to the majority of patients in our country may have to shut operations if subjected to frivolous and exorbitant lawsuits." Dr Alexander Thomas Executive Director of AHPI mentioned that over the last few months, IMA and AHPI have set up a working group to tackle the issue. Other solutions to address this issue were to set up arbitration centers in hospitals, appointing of an Ombudsman in each state and setting up of a fund where patients would get immediate compensation for catastrophic events. ]]> <![CDATA[Human resource requirement of 39 lakh people in healthcare by 2022]]> https://biospectrumindia.com/news/95/7030/human-resource-requirement-of-39-lakh-people-in-healthcare-by-2022.html https://biospectrumindia.com/news/95/7030/human-resource-requirement-of-39-lakh-people-in-healthcare-by-2022.html Mon, 13 Jul 2015 10:20:02 +0530 The ministry of skill development and entrepreneurship recently signed a MoU with ministry of health and family welfare to establish a framework for concerted and comprehensive joint action to address the need for skilled human resources in the health sector. Besides achieving the national goals of skilling youth so as to increase their employability, the MoU shall also seek to upgrade the quality and reach of human and infrastructural resources that is at the core of a quality healthcare system. Minister of state for skill development and entrepreneurship (Independent Charge) and Mos parliamentary affairs, Mr Rajiv Pratap Rudy and minister of health and Family welfare Mr JP Nadda were present at the MoU signing ceremony. This was the sixth Memorandum of Understanding (MoU) signed by the MSDE with a Central Ministry over the last three days. Speaking on the occasion, Mr Rudy said that skills and knowledge are the driving forces of economic growth and social development for any country. We are in cognizance of the huge demographic dividend that our country stands to reap, at this point in time and healthcare is one of the most important sectors for us. He said that according to an NSDC report, the health sector employs around 36 lakh employees and is slated to employ more than 74 lakh by 2022 which is more than double its existing workforce to meet the market demand. Hence there is an incremental human resource requirement of 38.93 lakh people which we will collectively address with the help and guidance of his senior cabinet colleague Shri Nadda. Mr Nadda in his address said that National Healthcare Policy 2015 clearly puts the focus back to the quality, affordability and availability of healthcare in the country. He said that is only possible when we have advanced and innovative technology, supporting available infrastructure and a powerful trained and skilled workforce to support the requirements. He thanked Shri Rajiv Pratap Rudy for extending his Ministry's support to health ministry in ensuring standardized training for the human resources in the sector. Few significant outcomes of collaboration: â€¢ Significantly increase the present capacities in areas of health sector to a minimum of one lakh trainees â€¢ Make significant savings of public resources by way of leveraging the existing infrastructure of government and private sector healthcare institutions to provide training against various short term job roles â€¢ Explore pooling of financial resources of the two departments and allow for international partnerships to provide greater financial muscle to the programme â€¢ Create a framework of certification by Health Sector Skill Council of select job roles and for absorption of the trainees in the health sector â€¢ Create a framework for Recognition of Prior Learning â€¢ Allow for seamless vertical and horizontal mobility of trainees at various levels of skill development By 2020 India is set to experience a dynamic transition as the population burden of the past turns into a demographic dividend, with 64 percent of the population in the working age group. Current predictions suggest a steady increase of the youth population to 464 million by 2021 from 430 million in 2011, when the median age is also expected to be 29 years making it one of the youngest countries in the world. Recognizing the need of the hour, the ministry will be making some strategic announcements in the presence of the Prime Minister, Mr Narendra Modi on July 15th which has been designated as World Youth Skills Day by UN. ]]> <![CDATA[BBC plans for nation's medtech accelerator]]> https://biospectrumindia.com/news/95/7423/bbc-plans-for-nations-medtech-accelerator.html https://biospectrumindia.com/news/95/7423/bbc-plans-for-nations-medtech-accelerator.html Mon, 13 Jul 2015 10:17:45 +0530 The BBC measures about 86 acres of land having three zones: ï‚§ Institutional area - 20 acres (composed of IBAB & CHG - Centre for Human Genetics)ï‚§ Innovation area - 10 acres (for start-ups)ï‚§ Industrial cluster area - 56 acres (Alexandria Biotech Park) The project was sanctioned 10 years ago in 2005 by the Department of Biotechnology (DBT). The total cost of the project has been Rs 50.9 crore. The civil construction has cost Rs 12.9 crore; internal lab fittings (by IBAB through KBITS grants) about Rs 16 crore; and lab equipments cost Rs 22 crore (from DBT). BBC's key features ï‚§ Provide key crucial link between academic institutions such as IBAB, CHG and the industryï‚§ Subsidized infrastructure along with mentorship, training, funding, networking support for start-upsï‚§ Central equipment facility catering to the needs of broad areas of Life Sciencesï‚§ Modular labs with an option to combine adjacent labs to create bigger unitsï‚§ Structured as 'section-8' not-for-profit company with independent and autonomous governance structure So far BBC has received 20 applications from prospective incubatees. The technical presentation pitch will be conducted in the last week of July 2015. The incubatees will be selected based on innovative potential, social impact, team strength, and technology readiness level among others. Way forward In the future, BBC will play a mentorship role for other clusters in Karnataka if needed, explained Dr Jitendra Kumar, â€?Director & Head, BBC. He also added, "At the moment, an early-stage venture funding system is being created by KBITS. Also seed funding from DBT and KBITS is on the planning horizon. We are also in the process of conceiving to create a medtech accelerator." The BBC also plans to have additional infrastructures including animal house, green house, library and information system, medtech accelerator, technology center, and additional lab spaces. ]]> <![CDATA[The unsung Indian heroes of the Medicine Makers 'Power List 2015']]> https://biospectrumindia.com/features/95/7847/the-unsung-indian-heroes-of-the-medicine-makers-power-list-2015.html https://biospectrumindia.com/features/95/7847/the-unsung-indian-heroes-of-the-medicine-makers-power-list-2015.html Sat, 11 Jul 2015 08:50:00 +0530 In a bid to celebrate the achievements, discoveries and leadership capabilities of influential people in the field of medicine, Medicine Makers, a UK-based publication had published a 'Power List'-an index of the most 100 influential people in drug development and manufacturing. The list was developed by the publication in three stages. In stage one, it invited readers to nominate those who they thought deserved recognition. In stage two, a jury of four noted medicine makers (who prefer to remain anonymous) selected their top 100 from the slate of nominees: the results were consolidated into a list of 100 names. In the final stage, the jury ranked the list, and the average rankings were combined to provide the final power list.The top 5 in 'The Medicine Maker Power List' are: Anthony Fauci, director, National Institute of Allergy and Infectious Diseases, USA, Kiran Mazumdar-Shaw, chairman & managing director, Biocon, Sir Andrew Witty, chief executive officer, GlaxoSmithKline, Arthur D. Levinson, chief executive officer, Calico and Heather Bresch, chief executive officer of Mylan. The prestigious list also includes few other fellow Indian researchers and leaders who have managed to grab a place among the Top 100 global leaders through their influential work and excellence in the field of science.Dr Vikramaditya G Yadav, assistant professor, Department of Chemical and Biological Engineering, The University of British Columbia, Canada Dr Vikramaditya G Yadav is one of the youngest Indian-origin achiever to be recognized by Medicine Makers for his formalization of 'biosynthonics', a novel paradigm for drug discovery and development based on metabolic and enzyme engineering. Among other innovations, he and his team are working to construct artificial human brains that help in testing of neurodegenerative drugs and research on neurodegenerative disorders. Q. Please tell us about your work and achievements in detail. Biosynthonics' - a novel paradigm for discovering and synthesizing potent bioactive molecules - is the focus of my research group. We also focus on formulation and assembly of drugs and their translation to certain pathological conditions. We have recently embarked on the development of a brain-on-chip device for preclinical testing of anti-neurodegeneration drugs. Biosynthonics is a response to the current drug discovery crisis in the pharmaceutical industry. The platform comprises of four principal domains - design, synthesis, exploration, and integration. In retrosynthetic analysis, a 'synthon' is defined as a structural unit, or building block, within a molecule that is the product of a specific synthetic operation. By clustering biosynthon gene combinations, permutations and mutations into biosynthetic operons to be expressed as heterologous metabolic pathways in tractable microbial hosts, one can readily generate pharmacophores which can be used in drug discovery Apart from this, we are working to construct artificial human brains in a variety of formats, one of which is a brain-on-chip in collaboration with colleagues from the biopharmaceutical industry and the Faculty of Pharmaceutical Science. The device mimics the human brain a three-dimensional models of human tissue that recapitulate the spatiotemporal complexities of the tissue microenvironment as they occur within the body. This provides a highly context-specific platform to test and validate lead compounds, which improves the success rate of compounds in the clinic. We plan to utilize this device to investigate fundamental details about neurotransmission and test lead compounds targeting two prominent neurodegenerative disorders, chronic traumatic encephalopathy (CTE) and frontotemporal degeneration (FTD) in a high-throughput manner. Q. How can this research bring about a change in current testing methods? The number of new drugs approved by the FDA each year has remained practically unchanged during the past decade despite a doubling in R&D expenditures over this period. In fact, candidate attrition rates and development times actually rose quite markedly during this period. It now takes over a decade to discover and develop a new drug, and statistics such as the one reported recently by Sanofi, the world's fourth-largest drug company by prescription sales, which recently put its own cost of bringing a new drug to market at $7.9 billion compared to an industry average of $5.8 billion, illustrate the magnitude of the crisis.Through Biosynthonics we can change the current scenario in drug development by leveraging the advances in science and technology. The platform could prove to be particularly effective in tapping into the chemistry of natural products, a veritable treasure chest of therapeutic compounds.Also brain-on-chip helps in pre-clinical testing of lead compounds targeting neurodegeneration. Although this process sounds straightforward, it is anything but. Maintenance of cortical nerve cell cultures is extremely challenging, and reliable operating procedures were only established very recently. Furthermore, cortical cell cultures do not incorporate key constituent tissues of the human brain such as the blood-brain barrier. As a consequence, diffusion of the lead compounds across the blood-brain barrier, which has long been the Achilles heel of drugs targeting brain tissue, is never actually evaluated until the molecules are tested in patients - a potentially calamitous scenario. Regulations stipulate that lead compounds exhibiting positive activity in cortical cell cultures must then be tested in whole animal models, preferably those that bear anatomical traits that are similar to humans. The greater the degree of similarity between the target organs in the animal model and human patients, the more insightful is the testing. Unfortunately, though, results from pre-clinical animal testing using the best neurodegeneration animal model that the pharmaceutical industry has at its disposal - that of the rodent - do not translate well to the clinic, and nearly all drug candidates targeting neurodegeneration fail when tested in real patients on account of poor safety and/or efficacy. Organs-on-chips are three-dimensional models that recapitulate the spatiotemporal complexities of the tissue microenvironment as they occur within the body. This provides a highly context-specific platform to test and validate lead compounds, which improves the success rate of compounds in the clinic.Q. Please describe your journey so far.I currently work as an Assistant Professor in the Department of Chemical & Biological Engineering at the University of British Columbia (UBC) in Canada. I hold a Bachelor of Applied Science degree in Chemical Engineering from the University of Waterloo. My first taste of the pharmaceutical industry came during my undergraduate tenure, as a research associate with TherapureBioPharma (formerly Hemosol, Inc.) and then as a bioprocess technologist by Sanofi Pasteur. At TherapureBioPharma, I worked extensively on bioprocess development for manufacture of the company's flagship product in receptor-mediated drug delivery. At Sanofi Pasteur, I was involved with the development of an early concept modular and disposable vaccine production platform for decentralized manufacturing. During my final year of studies at the University of Waterloo, I was invited to conduct research on tissue engineering in the laboratories of Dr Robert Langer and Dr Ali Khademhosseini at the Harvard Medical School's Division of Health Sciences of Technology. This proved to be a transformative experience for me and spurred to pursue a doctoral degree in Chemical and Biochemical engineering at the Massachusetts Institute of Technology (MIT) under the supervision of Dr Gregory Stephanopoulos.Q. Your views on being a part of the Medicine makers List? What challenges do you foresee now? A. I truly appreciate my recognition and would like to share this honor with three of his professors from MIT - Dr. Robert Langer, Dr. Charles Cooney and Dr. Bernhardt Trout. I am a strong advocate of philanthropic science and hope that soon people throughout the developing world, especially in my homeland, have access to the very best therapeutics at the lowest prices. We hope to continue in similar stead and successfully translate technological innovations to the pharmaceutical industry. After all, there is no greater feeling than to put smiles on people's faces. Mr Manish Vinayak Soman, President and CEO, Sciformix Mr Manish Soman was recognized by Medicine Makers for his instrumental role in helping Sciformix evolve from a niche area into a leading global scientific process organization for the biopharmaceutical, generic pharmaceutical, consumer product, medical device and contract research industries. Q. Please tell us about your work and achievements in detail?I have worked across organizations including Deloitte, Patni Computers, HP Enterprise Services and GENPACT over the past 20 plus years and helped to facilitate their growth into successful global businesses and practices. The experience I have gained in these roles has helped me to hone my relationship, leadership, planning, co-ordination and analytical skills. I have worked in the US, Europe, India and the Far East, with special emphasis in the life sciences, banking and financial services industries. I joined Sciformix in 2012 as President and CEO, because it gave me an entrepreneurial opportunity to grow something in a niche area and enticed me into taking the opportunity. Founded in 2007, Sciformix is a global scientific process organization (SPO), headquartered in the US, with operations in the UK, India and the Philippines. We partner with life science companies and provide them outsourcing services to help them develop, launch and sustain medical products that improve the quality of healthcare worldwide. Our services include safety and risk management, regulatory affairs & operations, and clinical research and post-approval support. I think my strength is that I believe in building strong executive teams and getting the most out of them, as well as inspiring their loyalty and making future leaders out of them. At Sciformix, we have made great strides in achieving our long-term strategy of focusing on evolving and enhancing our service and technology offerings, broadening our global reach and growing and diversifying our client and revenue base. Globalization, expansion and growth are key elements in client delivery and customer support. Our hearty 30-40 percent YOY revenue and employee growth are testaments to our successes. Last year we opened an office in the UK, we also organically grew in the Philippines two years ago and we continue to make key investments in strengthening our management team. Q. Your aims and goals?Emerging markets, such as India, China and Latin America, are becoming increasingly important for Big Pharma, generics and biologics manufacturers alike. These markets will contribute significantly to their revenue figures and this is where the majority of expenditure in medicines will come from in the future. Our aim is to help our clients proactively prepare for changes in the global environment and to penetrate these markets faster.The world we live in is changing rapidly, and generic and chemical drugs will be replaced by drugs with heavier molecular weight i.e. biosimilars/biologics. Around a third of the biopharmaceutical industry R&D pipeline comprises biologics. By 2016, 10 of the global top 20 bestselling drugs will be biologics and sales from biological medicines are set to account for 49 percent of the world's top 100 drugs in terms of revenue by 20181. Biosimilars/biologics bring a whole new set of challenges to drug manufacturers, especially generic manufacturers, in the area of drug safety and global regulations. This is where Sciformix can help.Sciformix is already doing a lot of drug safety work of biologics and more than 1/3 of the company is focused on biologics/biosimilars. We are well aligned to this kind of change and can help manufacturers who want to build biosimilars mature faster. By working collaboratively with generic manufacturers, we can help them prepare for the global challenges they will face in the future. Our rich knowledge of therapeutic areas such as oncology, autoimmune diseases, Central nervous system (CNS) and respiratory diseases etc. can help these organizations get to market faster and stay compliant with the changing regulatory times.Some other challenges our clients and the industry as a whole are facing includes: growing regulatory pressures, the ever increasing complexity of managing product lifecycles, and patient and payer pressure to get the safety, efficacy and price of the product right. Our goal is to partner with drug manufacturers and help them achieve success and lessen the burden of these dynamic and multifaceted challenges. Q. Please describe your journey so far?In today's global economy, traditional business models are being pushed to the breaking point and the challenges are great. Yet with these challenges come great opportunities and where successful organizations can differentiate themselves from the competition.Organizations are facing the challenge of having to find new revenues streams and are turning to emerging markets. Additionally, they are also facing fierce competition from generics and biosimilars and are looking to have a mixed portfolio of generic and innovative products. Other pressures include expediting product time to market, supporting global distribution channels, cost pressure and of course the ever-changing and complex regulatory environment. To stay ahead of the game and meet these opportunities head on, collaborations and partnerships are critical to a drug manufacturer's success.This is the reason how Sciformix came into being. We understand our client's needs and these global trends.Sciformix was founded with the clear intent to deliver niche scientific knowledge-based expertise solely to the Life Science industry. The founders of our company understood that at the core of addressing the vast challenges and complexities that were unique to the life science industry, was the science. Because of our specialized talent and focus on lifesciences (vs BPOs and KPOs who serve multiple industries), we have unique insights on what is missing from traditional service providers and are able to provide niche and customized support to our clients. By providing high quality scientific knowledge-based expertise we are able to deliver better quality outcomes and improved efficiencies across the entire lifecycle of our client's products.At the core of Sciformix since our inception is our excellence and expertise in science. Sciformix was founded in 2007 to serve large top-tier pharmaceutical companies and fill a growing need in scientific data analysis and reporting. The company has expanded its reach and portfolio of services to help small and mid-sized biopharmaceutical, consumer products and medical devices organizations. As market demands evolved, we expanded our footprint with the emergence of biologics. By adding value-added services and talent such as medical writing, medical affairs, scientific affairs and medical safety, we have been able to expand our portfolio and offer our clients more integrated and comprehensive solutions. Q. Your views on being a part of the Medicine makers List? What challenges do you foresee now?It is an honor and very humbling to be in such elite company. It gives all the people on the list, a platform to come together and take steps to boost the pharmaceutical industry, collaborate on formulating long terms solutions to industry problems, and finding smarter and sustainable ways to innovate, grow and contribute to the enhancement of healthcare products and services worldwide. One of the biggest challenges and feats that need to be addressed collectively would be to standardize regulations globally so that there is a commonality of purpose. Another area the industry needs to make great strides is in Big Data. On one end of the spectrum, we are being inundated with so many different sources of data (such as social media) in different formats (structures and unstructured), and on the other spectrum important clinical and product data is not being shared. Most of the data is of varying quality. Whatever happens, you can be certain that Sciformix will be ready to interpret and speed up access to all data in a form that manufacturers, payers and patients can understand, as well as provide the analysis that goes into making informed decisions throughout the product lifecycle. The industry needs to focus and spend money on big data analysis. The returns are inevitable. If we were to achieve this, it would revolutionize the Pharma industry, its entire manufacturing and commercial processes. But most importantly, it would make healthcare more inclusive than ever before in our history, and that I believe is something worth striving towards. Mr Ajaz Hussain, executive director, The National Institute for Pharmaceutical Technology and Education, USA Mr Ajaz Hussain has previously worked for the FDA, where he became deputy director of its Office of Pharmaceutical Studies in 2000. He also held a Senior Biomedical Research Scientist position. He is widely recognized for his leadership of several FDA initiatives such as Process Analytical Technology and Pharmaceutical Quality for the 21st Century. Mr Hussain serves as an advisor to generic and biosimilar companies in North America and in India helping organizations develop programs that enhance understanding of quality and regulatory compliance, and help them reduce risk of failure, time and cost of development and manufacturing.Q Please tell us about your work and achievements in detail?My professional mission has remained the same for decades - making high quality affordable. I believe in competition. It is the best approach to improve quality and affordability. I devote 50 percent of my professional time to National Institute for Pharmaceutical technology and Education (NIPTE). The mission of their work is to reduce cost, improve quality and enhance confidence. There are 14 Member Universities and the faculty at these universities come together to contribute to NIPTE's mission. I serve as an advisor to to generic and biosimilar companies in North America and in India. In today's regulatory environment, many executives and senior managers in the life science and consumer sectors are increasingly finding themselves in unfamiliar territory, even while they must continue to take rapid and assertive actions on investment strategies and development plans. Concern over these rising levels of product complexity and regulatory uncertainty is leading many executives and investors to seek reassurance that effective business processes are being established to mitigate risk of development failure and/or risk of regulatory non-compliance. Our core focus is efficiently developing and upholding credible scientific evidence to support product development, improve manufacturing and quality assurance, and reduce overall risk and uncertainty. Via this focus, we offer services to create sustainable competitive advantage and cost savings for companies that help to de-risk investments in complex, reduce risk of failure, as well as time and cost of development and manufacturing. We also help businesses implement processes that effectively fulfill expected management responsibility for GxP compliance and quality and ensure rigorous risk-management and effective root-cause investigations. We help in establishing knowledge management systems for effective use of prior knowledge and continual learning. Q. Your aims and goals? My consulting practice is also focused on 'making high quality affordable'. Primarily I serve as an advisor to generic and biosimilar companies in North America and in India. Through these efforts, I help to reduce risk of failure in development phase and reduce uncertainty companies' face in developing and seeking approval for complex generics and biosimilars. Following my career at FDA, I had the opportunity to lead the Sandoz biosimilars program before regulatory pathways were established in EU and USA. Reducing complexity and uncertainty for complex product development in an organizational setting where each function (e.g., analytical chemist, process engineer, formulation scientist) looks at the problem from their own viewpoint is what I enjoy doing in my consulting practice. I am often pulled into advising on cGMP compliance problems, I do not mind doing so for companies genuinely interested in improving. I am also devoting significant time to teaching 'Culture of Quality' at combines in India. This is giving me an opportunity to reconnect with India at multiple levels - this effort - I call it 'Dil Se' (from the heart). Q. Your views on being a part of the Medicine makers List? What challenges do you foresee now?I appreciate the nomination, selection and the recognition. In my career, I have considered such recognition as way to help my children appreciate my professional passions. Now that they have grown-up, perhaps they will still appreciate this recognition. Moving ahead, I see the need for significant efforts to be directed at improving the pharmaceutical educational system - at the college level and in continuing professional education - in India and around the globe. NIPTE is exploring ways they can contribute. NIPTE has established a Memorandum of Understanding with Sun Pharmaceutical Ltd in India to evaluate if an NIPTE - Sun Pharma collaboration is feasible to establish a Quality -by -Design training curriculum at Sun where NIPTE faculty will participate in the training of their staff. NIPTE will look for other such collaborative opportunities - in research and education - with other companies in the US and other regions particularly regions that export medicines to the USA. Clearly, research to develop rigorous methodologies for assessing equivalence and similarity will remain important. Science based risk-assessment, efficient quality by design methodologies for Nano-, pediatric medicines and continuous manufacturing and formulation design for continuous manufacturing are areas of high interest. ]]> <![CDATA[BD adds two new products into its prefilled drug delivery system profile ]]> https://biospectrumindia.com/news/95/6534/bd-adds-two-new-products-into-its-prefilled-drug-delivery-system-profile-.html https://biospectrumindia.com/news/95/6534/bd-adds-two-new-products-into-its-prefilled-drug-delivery-system-profile-.html Fri, 10 Jul 2015 14:29:00 +0530 With the aim to reduce medication and dosage errors and improved patient compliance to injectable drugs, two new prefilled drug delivery devices - one for chronic diseases and another for vaccination were introduced at Technovation 2015 on 10th July by BD Medical - Pharmaceutical Systems. BD Neopak is a single-dose, ready-to-use glass prefillable syringe system. It is an advanced version of normal prefillable syringe, particularly suitable for biotech drugs, that are more sensitive in nature and require delivery devices ensuring virtually no interaction and aggregation with the drug. BD Neopak offers additional benefits of PFS such as lesser injection time, lesser errors, reduced contamination and much better productivity to patients and clinicians. BD Uniject SCF (Sterile, Clean and ready to Fill) is a single-use prefilled auto disable injection system that protects against inappropriate needle reuse. Being tamper proof, this system can be used even by healthcare workers, for greater coverage of outreach programs such as mass immunization. Both forms of drug delivery will assist the process of administering pharmaceutical compounds to achieve desired effect far more quickly and effectively. "In the current environment, patients demand higher quality and more reliability in injectable drug delivery systems. Therefore there is an urgent need to be able to collaborate with industry leaders and introduce cutting edge solutions that will greatly benefit Indian patients. BD as a technology and innovation driven organization has been prudent to respond to evolving needs and provide great value to customers," said Mr Murli Sundrani, business director, BD Medical-Pharmaceutical Systems, BD India. Injectable drug delivery market is primarily driven by rising incidences of chronic diseases such as auto immune diseases, diabetes and cancer and healthcare costs are driving the growth in drug self-administration, particularly for chronic conditions. Today, prefilled drug delivery systems are considered to be the preferred mode of administering more than 50 injectable drugs. Countries like the US, Europe and Japan, pre-dominantly use the technology, while its usage is expanding in developing countries as well like in India and China. Prefillable syringes eliminate the risk of contamination and dosage error, assuring patient safety. Doctors, physicians and healthcare workers also find it convenient and less time consuming as the number of steps taken to prepare an injection with the conventional vial or an ampoule is reduced from 10 to just three with a prefillable device. Dr SG Kasi, principal investigator, Time & Motion Study said, "This is a first kind of study done in India which demonstrates the superiority of prefillables (PFS) over single and multi-dose vials in terms of time taken for one vaccination, vaccine wastage, and errors occurring during vaccination. The advantages of the PFS have been acknowledged by the CDC, which now recommends it as the "preferred" system of vaccine administration." Earlier, Indian Academy of Pediatrics Committee on Immunization (IAPCOI) in association with BD Medical-Pharmaceutical Systems completed a Time and Motion Study in India to assess the impact on vaccination efficiency with prefilled syringe. The study conducted in Mumbai, Hyderabad, Bengaluru, Delhi and Kolkata demonstrated the superiority of PFS over single and multi-dose vials; involving comparison in terms of efficiency associated with the vaccine administration process (preparation, injection and disposal) and rate of handling errors with safety implications. PFS was proven to be twice as fast as vials and handling errors were three times fewer than vials. ]]> <![CDATA[Cipla announces appointment of Ms Samina Vaziralli onto the Board of Directors]]> https://biospectrumindia.com/news/95/6545/cipla-announces-appointment-of-ms-samina-vaziralli-onto-the-board-of-directors.html https://biospectrumindia.com/news/95/6545/cipla-announces-appointment-of-ms-samina-vaziralli-onto-the-board-of-directors.html Fri, 10 Jul 2015 12:42:09 +0530 Cipla has announced the appointment of Ms Samina Vaziralli as executive director on its board effective 10th July 2015. Welcoming her appointment as a director, Mr Adil Zainulbhai, Independent Director and Chairman of the Nomination and Remuneration Committee, Cipla said, "I am delighted to welcome Samina to the Board. She will reinforce the commitment and continuity of the Hamied family's involvement in Cipla. She will help drive Cipla to achieving its strategic vision." Ms Samina Vaziralli said, "I am happy to be in position to contribute to steering Cipla as a member of the Board at this exciting moment. Cipla has made huge strides in the last couple of years in taking the business and the brand into new areas and I look forward to working with our leadership team on executing our strategy." The Board of Directors of the Company at its meeting held on 9th July 2015 has approved the divestment of its consumer healthcare business to a wholly owned subsidiary that is proposed to be incorporated. According to the company, this development gives scope to develop the division as a strong, customer focused business with operational independence and the ability to attract and develop expertise which is more FMCG-oriented. Commenting on these developments Mr Subhanu Saxena, MD and Global CEO, Cipla said, "I am personally delighted at having Samina on the Board as she will contribute greatly to the strategic direction of the Company. I am also very pleased that the Company is making such a positive move into the Consumer Healthcare space. There is a very good opportunity for Cipla, a Company which has contributed immensely to patient health, to also contribute to patient wellness. The over-the-counter business means that we can speak to the patient directly and help them to foster good health and illness prevention." ]]> <![CDATA[Cancer Genetics inks pact with ICON]]> https://biospectrumindia.com/news/95/5202/cancer-genetics-inks-pact-with-icon.html https://biospectrumindia.com/news/95/5202/cancer-genetics-inks-pact-with-icon.html Fri, 10 Jul 2015 10:55:38 +0530 Cancer Genetics Inc (CGI) has announced that it has entered into a partnership with the Laboratory Services group of ICON, the global CRO ICON's Laboratory Services provide global testing services to the pharmaceutical, biotechnology and medical device industries. The partnership will provide clients access to combined expertise ranging from complex, oncology-focused genomic testing to core central laboratory analysis, project and data management and sample logistics on a global basis. Together, the two companies will leverage their respective expertise to provide key insights to the oncology drug development and clinical trial process. ICON's expertise in strategic development and in management and analysis of lab data from large-scale clinical programmes, and CGI's extensive knowledge in applying genomics and other advanced technologies focused on cancer. The partnership is focused on providing a comprehensive, integrated and efficient solution for laboratory testing for global oncology trials from Phase 1 through Phase IV. "We are looking forward to working with the CGI team and to enhancing our client offering with complementary laboratory service programs," said Mr James Miskel, executive vice-president, ICON Laboratory Services. He added, "Together, CGI and ICON are uniquely positioned to provide a full range of comprehensive lab solutions for our customers with current and future oncology focused clinical trials." With the projected value of the cancer diagnostics market estimated to reach $169B globally by 2020, the industry has growing demand for complex oncology laboratory testing services. CGI provides complex genomic testing for six out of ten major pharmaceutical companies in the US. "This partnership will satisfy the enormous need among biotech and pharmaceutical companies for more efficient and comprehensive testing solutions by integrating CGI's specialized, genomic testing to ICON's laboratory solutions," said Mr Panna Sharma, CEO of Cancer Genetics." ]]> <![CDATA[Madras University researcher earns prestigious Fulbright Award]]> https://biospectrumindia.com/news/95/6467/madras-university-researcher-earns-prestigious-fulbright-award.html https://biospectrumindia.com/news/95/6467/madras-university-researcher-earns-prestigious-fulbright-award.html Fri, 10 Jul 2015 10:55:12 +0530 Nova Southeastern University (NSU) cancer researcher Appu Rathinavelu, Ph.D., was selected for a prestigious J. William Fulbright award to conduct cancer research and training in India. Dr. Rathinavelu is associate dean for institutional planning and development at NSU's College of Pharmacy and executive director of NSU's Rumbaugh-Goodwin Institute for Cancer Research. The Fulbright Program, the US government's flagship international educational exchange program, is sponsored by the US Department of State. Since 1946, the Fulbright Program has provided more than 360,000 participants from more than 180 countries with the opportunity to study, teach and conduct research, exchange ideas and contribute to finding solutions to shared international concerns. As a Fulbright recipient, Dr. Rathinavelu joins the ranks of recipients who have become heads of state, judges, ambassadors, cabinet ministers, CEOs, and university presidents, as well as leading journalists, artists, scientists, and teachers. They have been awarded 53 Nobel Prizes. Dr. Rathinavelu will use the grant to develop and validate new genomics-based tests that could help during the treatment of breast and prostate cancers. During the two- and three-month endeavors, he also will help establish research collaborations and train graduate student researchers at VRR Institute of Biomedical Science in Chennai, India, which is affiliated with University of Madras, where Dr. Rathinavelu completed his graduate training. Dr. Rathinavelu holds a US (7,875,603 B2) and Japanese (5436544 B) patent for discovering a small organic molecule called 'JFD' that is anti-angiogenic, meaning it 'starves' tumors and other cancer cells by preventing blood flow that supplies the tumors with oxygen and nutrients that would otherwise help them to grow and survive. This molecule is less expensive to manufacture, stable in storage, expected to be less toxic and is more effective against solid tumors. It is specifically designed to battle breast, ovarian, prostate, lung and colorectal cancers. He also holds a US patent for discovering a molecule called 'F16' (7,939,557 B2) that is more potent and is specifically designed to combat breast cancer cells. Dr. Rathinavelu has published more than 40 peer-reviewed research articles, served on the editorial board of several scientific journals and committees, co-authored a text book and given more than 75 presentations at national and international conferences. He received his Ph.D. in biochemistry from the University of Madras in India and conducted his postdoctoral training at Purdue University in West Lafayette, Ind. In 1992, he joined the Department of Pharmaceutical Sciences at Southeastern University's College of Pharmacy, which merged with Nova to become Nova Southeastern University in 1994. ]]> <![CDATA[Sanofi extends collaboration with MMV for malaria treatment]]> https://biospectrumindia.com/news/95/5072/sanofi-extends-collaboration-with-mmv-for-malaria-treatment.html https://biospectrumindia.com/news/95/5072/sanofi-extends-collaboration-with-mmv-for-malaria-treatment.html Fri, 10 Jul 2015 10:51:33 +0530 Sanofi has announced that the company will extend its collaboration with Medicines for Malaria Venture (MMV) to jointly develop a new single, fixed-dose combination therapy for malaria, the deadliest parasitic disease in the world. The announcement of the collaboration extension comes as Sanofi is preparing to participate in the Infectious Diseases World Summit 2015 in Boston. The collaboration began a three-year research project agreement in May 2011 to develop drug candidates from Sanofi's compounds selected for their potential activity against malaria parasites. At each stage, the project has been evaluated by a joint Sanofi/MMV steering committee applying MMV's criteria for compound progression. The collaboration has yielded two potential treatments, OZ439/Piperaquine and OZ439/Ferroquine, each of which is a single, fixed-dose combination therapy independent of artemisin. Extension of this collaboration will allow phase 2b trials for OZ439/Ferroquine to begin this summer. OZ439/Piperaquine is currently in a phase 2b clinical trial. At the end of phase 2b, the Joint Steering Committee will determine if either of the two combinations meet the criteria for advancement to phase 3 trials. "Sanofi has a deep commitment and long history of addressing public health threats like malaria. As resistance increases to current antimalarial therapies, it is critical that we innovate to improve the efficacy and convenience of antimalarial treatment," said Mr Gary Nabel, chief scientific officer, Sanofi. He added, "By joining the fight against infectious diseases around the world and extending the successful collaboration with MMV, we aim to stay one step ahead of this ever-changing threat and work together toward the eradication of malaria." The new combination therapies would be administered in a single-dose, representing an improvement in administration over the three-day courses used for ACT therapies. The efficacy of these single-dose administrations will be evaluated and compared to ACT existing treatments. ]]> <![CDATA[Novartis' heart drug gets FDA nod]]> https://biospectrumindia.com/news/95/6272/novartis-heart-drug-gets-fda-nod.html https://biospectrumindia.com/news/95/6272/novartis-heart-drug-gets-fda-nod.html Thu, 09 Jul 2015 12:50:06 +0530 Novartis has announced that the US Food and Drug Administration (US FDA) has approved Entresto (sacubitril/valsartan) tablets, previously known as LCZ696, for the treatment of heart failure with reduced ejection fraction. Entresto will be available on prescription for patients whose condition is classified NYHA class II-IV, indicated to reduce the risk of cardiovascular death and heart failure hospitalization. It is usually administered in conjunction with other heart failure therapies, in place of an ACE inhibitor or other angiotensin receptor blocker. "Despite the uncertainty and high financial risk we designed the world's largest heart failure trial to compare Entresto to the previous gold standard. As a result millions of people diagnosed with reduced ejection fraction heart failure now have a much greater opportunity to live longer and stay out of hospital," said Mr David Epstein, division head, Novartis Pharmaceuticals. He added, "We recognize our responsibility to ensure Entresto reaches the US patients and prescribers as soon as possible and will begin shipping in the US in the coming week." The FDA's decision is based on results from the 8,442-patient PARADIGM-HF study which was stopped early when it was shown Entresto significantly reduced the risk of cardiovascular death versus ACE-inhibitor enalapril. At the end of the study, patients with reduced ejection fraction who were given Entresto were more likely to be alive and less likely to have been hospitalized for heart failure than those given enalapril. Analysis of safety data showed that Entresto had a similar tolerability profile to enalapril. Entresto is currently undergoing review by Health Authorities around the world, including in Canada, Switzerland and the EU. ]]> <![CDATA[BIRAC seeks proposals under 7th call for Biotechnology Ignition Grant]]> https://biospectrumindia.com/news/95/4433/birac-seeks-proposals-under-7th-call-for-biotechnology-ignition-grant.html https://biospectrumindia.com/news/95/4433/birac-seeks-proposals-under-7th-call-for-biotechnology-ignition-grant.html Thu, 09 Jul 2015 12:49:00 +0530 The BIG scheme was initiated in order to support entrepreneurs with an exciting idea that may be in the nascent and planning stage. This scheme is designed to stimulate commercialization of research discoveries by providing very early stage grants for the development and maturation of those discoveries into marketable product or intellectual property (IP). In other words to, to help bridge the gap between discovery and invention. The online submission of proposals is allowed under BIG Scheme. The last date to submit the same for the 7th call is on August 07, 2015. The BIG scheme is directed towards the scaling up and validation of Proof of Concept ideas. And to encourage researchers to take technology closer to market and importantly to excite interest of potential licensees or investors. BIG scheme supports only up-to proof-of-concept stage. Funding will be in the form of Grant-in-Aid limited up-to Rs 50 lakh. The period for the study would generally not exceed 18 months. The funding to the BIG Innovator by the BIG Partner will always be in the form of Grant-in-Aid. No royalty will be charged on the disbursed fund to the BIG Innovator by the BIG Partner. Funding may also be used for conducting limited market research, patenting costs, working capital during the period, travel, salary etc. The scheme would be managed by the BIG Partners. These include C-CAMP, FITT, IKP Knowledge Park, Venture Centre and KIIT Incubator. The BIG Partners would provide mentoring and hand-holding for activities related to mobilizing resources, IP management, legal and contracts and other business development related activities for the BIG innovators. They will monitor targeted milestone and disbursement of funds and also organize workshops, meeting, travel etc. The target groups for the Biotechnology Ignition Grant (BIG) scheme include potential entrepreneurs from academia or an Incubatee (PhDs, Medical degree holders or Biomedical Engg. Graduates) who have an exciting idea that can be translated into a product and have an unmet need for mentorship and funding. The Biotechnology Ignition Grant would help to support and nurture these high risk early starters and their ideas. ]]> <![CDATA["India needs to have better drug & IPR policy"]]> https://biospectrumindia.com/interviews/95/4600/india-needs-to-have-better-drug-ipr-policy.html https://biospectrumindia.com/interviews/95/4600/india-needs-to-have-better-drug-ipr-policy.html Wed, 08 Jul 2015 12:37:00 +0530 Q: How do you rate the performance of the PM Modi led government in your sector? Modi government has taken some proactive steps in last one year, which has had a positive impact on the pharma industry. Q: Which are the areas where some progress has been witnessed if any? What are your expectations for next one year? Allowing up to 100 per cent Foreign Direct Investment (FDI) in medical devices in the pharmaceutical sector is a positive move. This is likely to attract more investments and boost the domestic manufacturing. Provision of essential medicines at lower rates is also a welcome step from which many will benefit. In the last one year, more than 300 life saving medicines which are used to treat life threatening diseases have been brought under drug price control by the Modi government. Q: Where do you want to draw the attention of ministries concerned? Despite some of the drugs being banned internationally, a large number of drug combinations are widely sold in India without the necessary regulatory approvals,. We need to align our policy on this with other western countries. There is lack of transparency regarding government's strategy on the intellectual property rights (IPR). Despite India being The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) compliant, this is sending a false signal. Further, the government is yet to share the new IPR policy. ]]> <![CDATA[LeadInvent named among top promising life science technology solution providers]]> https://biospectrumindia.com/news/95/7138/leadinvent-named-among-top-promising-life-science-technology-solution-providers.html https://biospectrumindia.com/news/95/7138/leadinvent-named-among-top-promising-life-science-technology-solution-providers.html Wed, 08 Jul 2015 12:31:02 +0530 LeadInvent is an integrated drug discovery company working at the fore front of bringing newer treatment options to patients in oncology and mens's health. The start up which incubated from IIT-Delhi, has recently made it to CIO Review magazine's top list of promising pharma and life sciences technology solution providers. CIO Review has chosen LeadInvent for its 20 most promising pharma and life sciences technology solution providers in 2015. The positioning is based on LeadInvent's core technology and scientific team that allows for rapid drug development with rational approach. The annual list of companies is selected by a panel of experts and members of magazine's editorial board to recognize and promote technology entrepreneurship. The team at LeadInvent comprises of scientists and business leaders with extensive experience in pharma and drug development space. Earlier it was awarded as Asia Pacific Emerging Company of the Year 2011 by the BioSpectrum. It has worked with multiple partners from India and abroad. The company has received multiple grants from the government of India and has developed unique molecule simulation technology platform that allows the team to rationally design new molecules with minimum hit and trials. LeadInvent leverages nano technology making existing drugs more safe with better efficacy providing a unique blend of innovation and treatment options for patients. ]]> <![CDATA[Global biotech industry continues to sizzle, market capitalization surpasses $1 trillion ]]> https://biospectrumindia.com/reports-white-papers/95/4651/global-biotech-industry-continues-to-sizzle-market-capitalization-surpasses-1-trillion-.html https://biospectrumindia.com/reports-white-papers/95/4651/global-biotech-industry-continues-to-sizzle-market-capitalization-surpasses-1-trillion-.html Wed, 08 Jul 2015 11:39:37 +0530 The global biotechnology industry reached new heights in 2014, setting records on virtually every major financial metric, including revenues, profitability and capital raised. These positive performance indicators, combined with several high-profile product successes and a strong year for new drug approvals, drove the industry's total market capitalization above the $1 trillion threshold for the first time in its history. These and other findings were released in Beyond borders: Reaching new heights, Ernst & Young's 29th annual biotechnology industry report. According to Mr Glen Giovannetti, EY's Global Life Sciences Leader, "The global biotechnology industry's outstanding performance and maturation are driving optimism that a new age of biotech innovation will create long-term value for companies, their investors, and patients. Investors are bullish on the future, investing historic amounts in the smaller players that will drive future breakthroughs." But success can engender its own challenges. "Unprecedented product approvals have also brought unprecedented pricing pressures," added Mr Giovannetti. "Companies will need to continually demonstrate how their products deliver value and contribute to the overall sustainability of health care systems." Key results highlighted in the report include: ï?µ Revenue jumps: Companies in the industry's established biotech centers (the US, Europe, Canada and Australia) generated revenues of $123 billion, a 24 percent increase from 2013, and a new high. Excluding the unprecedented growth of one industry leader, Gilead Sciences, revenues in 2014 would have increased a healthy 12 percent. ï?µ Profitability for all the right reasons: Net income reached a historic high of $14.9 billion, a 231 percent increase from the prior year. While much of this increase was attributable to the strong performance of Gilead Sciences, overall net income still doubled even after adjusting for that company's performance. In contrast to 2009-2012, when biotechnology companies achieved profitability via cost cutting, the increase in aggregate net income in 2014 was driven by solid sales of newly launched products. ï?µ Research and development (R&D) spending grows: R&D spending, a key indicator of the health of the sector, increased by 20 percent. This was the second year in a row that R&D spending outpaced the sector's revenue growth (adjusted for the skewing factors mentioned above), and smaller companies in both the US and Europe drove the uptick. ï?µ Fundraising sets records: Biotech companies in the US and Europe raised $54.3 billion in 2014, a whopping 72 percent increase from the strong funding results achieved in 2013. Companies raised a record $28.3 billion in non-debt financing, driven by the booming market for IPOs and follow-on offerings. "Innovation capital" - defined as the amount of equity capital raised by companies with less than $500 million in revenues and a key metric of the sustainability of earlier stage biotechnology companies - hit an all-time high of $27.6 billion. That amount represents a 120 percent increase from the annual average achieved from 2009-2012. ï?µ Venture financing reaches near-record: The US and European companies raised US$7.6 billion in venture capital, a 28 percent increase from the prior year and just shy of the all-time record of $7.9b raised in 2007. In a positive sign for innovation, companies raising early-stage rounds captured $1.8b, the greatest amount in at least the last decade. ï?µ A wide-open IPO window: A record-breaking 94 US and European biotech companies went public in 2014, shattering the previous record of 79 IPOs in 2000. The $6.8 billion raised from these IPOs is the second-highest total in the industry's history, surpassed only by the $7.8 billion raised during the genomic bubble of 2000. The IPO window, which began in 2013, remained strong for eight consecutive quarters, another new record. ï?µ Drug approvals surge: Efforts by the US Food and Drug Administration to get differentiated medicines to market contributed to 41 product approvals in 2014, up from the 27 approvals in 2013. More than three-quarters of these 2014 approvals were on first filings. ï?µ M&A skyrocket: M&A activity in 2014 reached a 10-year high in deal volume as pharmaceutical companies increased their buying activity. There were 68 biotechnology M&A deals with a total value of $49 billion in 2014. 2014 was also the most lucrative time in at least the last eight years for biotechs to enter alliances. As a percentage of total deal value, up-front payments reached 11 percent, while the total dollars paid up front soared 96 percent to $5.1 billion. For all its successes, the sector has some significant challenges ahead. "A number of mature biotech companies may face additional headwinds," said Mr Jeffrey Greene, EY's Global Life Sciences Transactions Advisory Services Leader. "As firms deal with pricing pressures and increased competition, including from biosimilars, they will need new sources of growth. Achieving such growth through deals and acquisitions will likely be more costly and challenging. Today's M&A landscape is clearly a seller's market. Assets that could tangibly affect a buyer's financial performance are scarce, and they will command premium prices." ]]> <![CDATA[Merck sells its migraine drugs to Allergan ]]> https://biospectrumindia.com/news/95/6162/merck-sells-its-migraine-drugs-to-allergan-.html https://biospectrumindia.com/news/95/6162/merck-sells-its-migraine-drugs-to-allergan-.html Wed, 08 Jul 2015 11:37:12 +0530 Allergan and Merck have announced that they have entered into an agreement under which Allergan will acquire the exclusive worldwide rights to Merck's investigational small molecule oral calcitonin gene-related peptide (CGRP) receptor antagonists, which are being developed for the treatment and prevention of migraine. The transaction is subject to expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (HSR). Under the terms of the agreement, Allergan will acquire these rights for an upfront payment of $250 million, $125 million of which is payable upon HSR clearance and $125 million of which is payable in April of 2016. Merck will additionally be entitled to receive potential development and commercial milestone payments and tiered double-digit royalties based on commercialization of the programs. Allergan will be fully responsible for development of the CGRP programs, as well as manufacturing and commercialization upon approval and launch of the products. "The agreement to acquire exclusive worldwide rights to Merck's CGRP migraine development program builds on our existing strength in neurosciences and helps position Allergan as a potential leader in the acute treatment of migraine and prevention of migraine for millions of patients," said Mr David Nicholson, executive vice-president, Global Brands Research and Development at Allergan. He added, "With two novel oral therapies in development for treating and preventing migraines, we have the opportunity to provide therapies that could alleviate an intensely debilitating and immobilizing condition for patients worldwide. We look forward to supporting the continued development of these programs and to potentially bringing these new therapies to market." "We are pleased that this agreement will enable Allergan to advance these promising molecules for the potential benefit of migraine sufferers, and that Merck will be able to continue to further focus our research and development resources on our priority therapeutic areas," said Mr Iain D Dukes, senior vice-president of business development and licensing, Merck Research Laboratories. ]]> <![CDATA[Sartorius Stedim Biotech acquires Cellca]]> https://biospectrumindia.com/news/95/4553/sartorius-stedim-biotech-acquires-cellca.html https://biospectrumindia.com/news/95/4553/sartorius-stedim-biotech-acquires-cellca.html Wed, 08 Jul 2015 11:23:37 +0530 Sartorius Stedim Biotech (SSB) has acquired Germany-based Cellca, a cell line and process development company. Through this acquisition, SSB is further expanding its service offering for process development. The company has already strengthened this segment by its two recent acquisitions of BioOutsource and TAP Biosystems. Mr Reinhard Vogt, member of the SSB executive committee for marketing and sales, said, "Together with our single-use products, media and testing services, we are creating an attractive package, above all for young biopharmaceutical companies that need robust processes for the manufacture of their biologics." "Due to its global presence and high reputation, SSB is an ideal partner for Cellca. We now have a strong base to further expand and develop our business internationally," said Mr Hugo de Wit, managing director, Cellca. ]]> <![CDATA[How IIT-M's Bioincubator is changing the face of biotech start-ups era]]> https://biospectrumindia.com/interviews/95/6472/how-iit-ms-bioincubator-is-changing-the-face-of-biotech-start-ups-era.html https://biospectrumindia.com/interviews/95/6472/how-iit-ms-bioincubator-is-changing-the-face-of-biotech-start-ups-era.html Wed, 08 Jul 2015 08:30:00 +0530 It is currently funded by Biotechnology Industry Research Assistance Council (BIRAC), and incubates start-ups in the area of biotechnology. In his special interview to BioSpectrum, Prof Guhan Jayaraman, department of biotechnology, Bhupat and Jyoti Mehta School of Biosciences, IIT-Madras, sheds light on how the government, industry and academia can collaborate together in revolutionizing the birth of biotech start-ups era.Q: What is the incubation model that you follow at the centre? Prof Guhan: Start-ups who are interested in being incubated have to apply through the website with a brief proposal. They will be called for a presentation before the Bioincubator Screening Committee consisting of academics, entrepreneurs, scientists from industry and medical institutions. The committee selects them based on five criteria: Technical merit of the proposal, business strategy for commercialization, team expertise, availability of seed-funding or venture capital and compatibility with the infrastructure and space available in the bioincubator. The selected companies are allowed to incubate for an initial period of 2 years which is extendable, depending on progress and financial sustainability of the incubated company and other assessment criteria. The Bioincubator provides a comprehensive wet-lab facility consisting equipments for microbial or cell culture, bioprocess engineering, molecular biology and analytics. It also provides technical services and, through the IIT-M Incubation Cell, it provides the incubated companies with legal, accounting and other non-technical services. It also connects the incubated companies with a mentor network consisting of academics, biotech entrepreneurs, industry experts and venture capitalists. In addition, the Bioincubator also provides linkages with other institutions, and incubation centres for using specialized facilities which are not available at the IIT-M Bioincubator. Being incubated in an academically-linked ecosystem also provides the start-up companies with a rich resource of faculty mentors, and students are also hired for internships and employment. The IIT-M Bioincubator does not by itself provide seed funding. Q: How can this model be replicated to kick-start biotech start-ups boom in India? Prof Guhan: BIRAC has already identified and funded a dozen such bioincubators across the country, including three in IITs. However, it is not enough to provide funding to the bioincubators and expect immediate success stories. The Government (BIRAC), industry and academia need to be more holistically involved in this process to streamline the functioning of bioincubators, identify promising companies or technologies which require support and minimize chances of failure. There needs to be a thorough understanding of the bioincubation process and factors which will give better chances of commercial success. Finally, bioincubators need to be located in an ecosystem where there is a rich mix of industry-academia interaction and a diverse set of start-up companies. Q: What are the key investments needed to create, say, 2000 biotech start-ups by 2017? Prof Guhan: Long-term venture capital and availability of physical infrastructure are no doubt the key ingredients for biotech start-ups to test ideas and build technologies. However, even more critical is availability of right mentors and right advice at key stages of incubation. Bioincubators (and BIRAC) need to identify such people and enlist their support for mentoring start-up companies. The established biotechnology industries also need to form a support structure (e.g., a consortium or a corpus fund), wherein they can mentor or financially support (in exchange for equity) start-up companies. Lastly, a concerted effort needs to be made in manpower training and development, especially for industrial biotechnology. These should include post-finishing schools in biotechnology and entrepreneur development. Creating a large number of biotech start-ups is not the main requirement, as creating many successful start-ups with innovative technologies. So, identification of such start-ups, providing them long-term venture capital and mentoring them at key stages is more important than providing the investment for a large number of start-ups. Q: In the current situation, how many biotech start-ups can an incubation centre produce in a year, given the challenges in funding and infrastructure? Prof Guhan: Biotech start-ups will require a long time for incubation. A typical incubation centre can incubate 12-15 start-ups at any given time and probably graduate 2 -3 start-ups a year after achieving full maturity. Currently, one does not foresee any bioincubator graduating successful start-ups in the next 3 -5 years. Q: Tell us about the uniqueness of your incubation centre. Prof Guhan: The IIT-M Bioincubator has the unique advantage of being located in the IIT Madras Research Park which is a rich ecosystem consisting of a diverse array of technology companies, many of them being start-ups. Being adjacent to the IIT-M campus, this ecosystem provides a fertile ground for industry-academia interaction. Since different types of technology companies are being incubated at the Research Park, it provides an atmosphere for cross-fertilization of ideas, examples of diverse business models and opportunities for networking with entrepreneurs in different fields. Biotech start-ups have higher chance of success when they are incubated in such an ecosystem, rather than a specialized silo. Therefore, the IIT Madras Research Park model needs to be replicated across the country, by providing a diverse environment where there is rich academia-industry interaction and start-ups co-exist with established companies in different fields. Q: Briefly tell us about the success stories achieved at the centre? Prof Guhan: It is too early to talk about success stories. We have incubated just 4 companies. Q: Do you see a rise in the erection of number of biotech start-ups? Or is it dwindling? Prof Guhan: Three years ago, BIRAC initiated the establishment of a number of bioincubators and start-ups receiving the Biotechnology Ignition Grants (BIG). Since then there has been an exponential increase in the number of start-ups at the incubation centres. So long the Government continues this healthy policy and industry also joins the act, these numbers will continue to rise. Q: Are you seeing any trends in biotech start-ups climate? Prof Guhan: Most of the biotech start-ups seem to be focused in the healthcare sector, especially diagnostics and medical devices. There are not enough start-ups in the area of industrial biotechnology, but there is a big market here. Q: Where can Indian incubation centres improve on? Prof Guhan: Indian incubators have to learn from the experience of successful incubators around the world, and yet learn to succeed under Indian conditions. The Government, academia and biotech industry need to come together and engage with them and provide them long-term support. Each incubator needs to develop its own niche areas of expertise and yet network strongly with other incubators for sharing infrastructure, ideas and mentors. This is only the beginning. We have a lot to learn and a long way to go, but patience and self-belief are the key ingredients along with substantial long-term investment. There is no fixed template available for success, but broad guidelines can be evolved over a period, which will perhaps improve success rates. There is a need for regular workshops and brainstorming in this area, which is largely missing. The bioincubators need to generously share ideas and infrastructure, as well as develop a strong network of mentors. ]]> <![CDATA[100 Percent FDI in medical devices: A step in the right direction?]]> https://biospectrumindia.com/features/95/7178/100-percent-fdi-in-medical-devices-a-step-in-the-right-direction.html https://biospectrumindia.com/features/95/7178/100-percent-fdi-in-medical-devices-a-step-in-the-right-direction.html Wed, 08 Jul 2015 08:26:00 +0530 In a bid to boost the indigenous manufacturing of medical devices in the country, the union cabinet has approved the amendments in the existing Foreign Direct Investment (FDI) policy to allow 100 percent foreign investments into medical devices. According to Mr Sanjay Banerjee, chair - AdvaMed India Working Group, "We believe that the decision is a step in the right direction and will enable the medical device industry to significantly increase investment, innovation and manufacturing in the long run. This decision will also act as a catalyst for the development of indigenous MedTech industry and will also have spillover effects in several ancillary industries. "He added, "We are encouraged by the government's efforts to delineate medical devices from drugs through the FDI policy. In India, the medical devices sector currently constitutes only 6percent of total healthcare spending, and its ability to address the country's growing disease (particularly non-communicable disease) burden has historically been limited by the fact that medical devices are treated as drugs. The recognition of the sector as a distinct and crucial pillar of the medical device industry in the policymaker's mind is the first step towards creating a conducive environment."While FDI for green-field projects is under automatic route, brown-field projects are placed under government route. "Permitting 100 percent FDI in brownfield projects will not only kill the existing domestic manufacturers by making them easy target for takeovers but will also defeat the very purpose of reducing import dependency or encouraging manufacturing of medical devices within the country. By permitting 100 percent FDI in brownfield projects, we are only encouraging cherry-picking by foreign companies. Our reasons are not aimed at scaremongering but based on past experience and ground realities," said Mr Rajiv Nath, forum coordinator, AIMED.He further added that even for Greenfield projects, there has to be a condition that at least 60 percent of overall goods being sold by a foreign company in India have to be manufactured within the country. "Unless, this is done, I firmly believe that manufacturing of medical devices within the country will never take off and India will continue to be heavily import dependent," he said. American Chamber of Commerce (AMCHAM) in India has said that 100 percent foreign direct investment (FDI) in the medical devices sector will attract US firms to invest and manufacture in India.Mr Banerjee agreed, "Yes, we believe that this move will spur investment, innovation and manufacturing in the long run. Our member companies have a long-term commitment to India and actively contribute to improving public health and strengthening the health system in India. These companies recognize that in order to be successful in India, they must build lasting partnerships, undertake capacity-building initiatives, and develop programs outside of their traditional business models to address India's health and health care delivery challenges. They are eager to invest in India's economy, and bring with them technical expertise, investment tools, and research and development capabilities and believe that the medical device industry in India is poised for spectacular growth and innovation if a supportive policy environment can be established and maintained in India."However, well that might seem like a good way to increase investment, it is not really a question of capital, to boost the sector, opined Mr Nath, "Question is not really of 'investment' but of creating conducive healthy environment for domestic manufacturing to flourish. One cannot have a decade of myopic and derailing policy regime and investment climate leading to near demise of Indian manufacturers and then top it up with another myopic demoralizing policy - just to show that we are doing something. FDI is not panacea for all ills plaguing the medical device industry. This kind of announcement - we are permitting 100 per cent FDI - is the easiest, almost lazy way out to grab some headlines. But it leaves the problem where it was. You want the manufacturing to flourish here, then one needs to sit with the industry captains, listen to their problems and take corrective measures. One needs to learn from countries like China or US as to how they protect and encourage their domestic companies. Investments may come but it will be for cherry picking and will not really help achieve PM Modi's objective of 'Make in India'.A right policy and regulatory framework is need of the hour. "At this stage though, the 100 percent FDI announcement is only an indication of the government's eagerness to promote the medical device industry as an essential segment of the healthcare industry. In order for intent to translate into concrete action, other critical factors, such as a predictable, globally harmonized regulatory framework, availability of an adequate ecosystem together with an appropriately skilled workforce also need to fall into place," said Mr Banerjee.Together with appropriate regulations, what is also needed is a suitable legislations for the protection of intellectual property. He added, "Medical devices feature a wide variety of different types of technologies, often in combination. Regulations providing robust protection to intellectual property will significantly boost investor confidence.""Make in India": A boon for Medtech sector?Medical device industry has been recognized by the Government of India as one of the five key sectors which can play a catalyst's role in shaping Prime Minister Mr Narendra Modi's vision of 'Make in India'. This campaign throws up opportunities for growth of domestic medical devices industry, which is not only underinvested but heavily import-oriented at present, says WHO."We are very encouraged by the Prime Minister's call to medical device manufacturers to 'Make in India'. Several of our member companies have already established manufacturing units in India and India is being increasingly seen as an R&D base. The medical device industry sees itself contributing significantly to India's healthcare ecosystem including patients' issues of availability and access. Like in the case of 100 percent FDI, "Make in India", will become a reality only if an appropriate regulatory framework is first created, said Mr Banerjee."Nonetheless, I would like to emphasize that the growth potential can be realized only if government puts in place a forward looking and long-term enabling policies and regulatory framework which encourages manufacturing within India and helps Indian companies compete with major competitors from China and US. The right policy push and regulatory framework, as of now, is not in place. We do hope, the situation is corrected soon," said Mr Nath. According to Mr Nath, Rationalization of Tax Structure, An Incentivized Export Substitution Policy, Preferential Public Procurement Policy and De-clubbing of Medical Device industry from Drug & Cosmetics Sector can immensely help the medical device industry. ]]> <![CDATA[An exclusive look inside KIIT's hottest tech biz incubator]]> https://biospectrumindia.com/interviews/95/4206/an-exclusive-look-inside-kiits-hottest-tech-biz-incubator.html https://biospectrumindia.com/interviews/95/4206/an-exclusive-look-inside-kiits-hottest-tech-biz-incubator.html Tue, 07 Jul 2015 14:55:10 +0530 Dr Mrutyunjay (Jay) Suar, the director of the school of biotechnology, KIIT University, and CEO of KIIT-TBI, shares some of his revealing insights into the incubator's model and uniqueness, success stories and the roadmap on how to kick-start the biotech boom in the next couple of years in the nation. Q: What is the incubation model that you follow at your TBI? Dr Jay: Being primarily a University-based incubator; we focus on translating research entrepreneurial avenues. We mostly encourage 'Technology Platform Model' wherein start-ups sell or rent technologies to various established players. However, more recently, we are also getting into the Research Intensive (or royalty income) Pharmaceutical Companies or RIPCO (start-ups that research and develop a new product to finally license it to a big pharma or biotech company in exchange for a royalty on sales); and Fully Integrated Pharmaceutical Company or FIPCO (start-ups that launch their own product) models as well. We also know that no single model can be followed in an incubator, and that's the reason we are competitive to nurture diversified innovative ideas to translate into a product or process with high commercial values. Q: How can this model be replicated to kick-start the start-up boom in India? Dr Jay: Life Sciences start-up culture needs to be cultivated not only in metro big city hubs like Bangalore, Pune, Hyderabad, but also in places like Chandigarh, Bhubaneswar, Dharwad, Mysore, Dehradun, Tirupati, and Durgapur. Each biotech start-up has its own dynamics and need, which cannot be generalized, therefore 100 smart cities should put biotech start-up hubs as a part of an integrative planning. More focus must be given on the technological interventions that can be introduced based on local area conditions but has a national and global perspective. Q: What are the key investments needed to create, say, 2000 biotech start-ups by 2017? Dr Jay: Biotechnology is different from IT start-ups where the infrastructure costs are only related to computer and software investments. But, in biotech starts-ups there is a need of an ecosystem with high technology-clustered equipment facilities. Also, the broad spectrum of areas under biotechnology makes it difficult for a funding agency or the government body to understand the investments required. Say for example, bioinformatics related research would need the same infrastructure costs as the IT industry. Biopharma and related areas would require capital investments on a different scale. Biomedical areas would require investments of the electronics industry. This sheer multi-disciplinary nature of work, requires a relook at how investment policies or methodologies work. However, critical to all the monetary, policy implementation is expert manpower. So for a biotechnology start-up boom, investing in quality manpower that would be industry ready is a must. The new government's skilled India policy must have biotechnology as a thrust area. Product-oriented start-ups must also be equaled with service-oriented start-ups particularly in healthcare sector where ITeS and biotech have a big role. Somewhere, product testing and validation lab should be established to cater to the need of early start-ups engaged in product development, which will give them an edge in the market. Also, recognizing biotechnology research as a priority sector and lending in banking parlance would provide access to the markets, which would in turn help start-ups raise money. The recent announcement by Securities and Exchange Board of India (SEBI) in regard to listing of biotechnology companies is welcoming, however, we believe it would take some time for the industry to get accustomed. Q: In the current situation, how many biotech start-ups can an incubation centre produce in a year, given the challenges in funding and infrastructure? Dr Jay: The number of start-ups depends upon the dynamism of the ecosystem and culture prevailing in the region. Bangalore, being an early start-up destination, must be replicated in many other cities. Early stage start-ups need anything between INR 20-30 lakh, which can be supported. From a pool of 30 start-ups, at least 5 companies can be formed every year from a start-up incubator, depending on the area of work they are into including diagnostics, agri-biotech, environmental biotech, biopharma, and biomedical among others. Among these 5 companies, 1 to 2 will become big to employ at least 30 employees, which is a success story, considering that it is a start-up. Q: Tell us about the uniqueness about your incubation centre. Dr Jay: Our University-based incubation system is our strength. Given that we have schools of electrical & electronics engineering, IT, management, and law, of which at least 15 percent of the faculties are involved in promoting entrepreneurship. So the start-ups would not need to wait for advice. The school of management would provide business support. Even programs can be designed where the management students (as a mini project for their coursework) can develop an innovative market survey or analysis method to help a biotechnology start-up. Also, KIIT-TBI is the only incubation center in Odisha. Considering that the KIIT School of Biotechnology has more than 600 undergraduate and master's students along with a 100 PhD scholars, we have formed a critical mass by engaging biotechnology start-ups with chemical technology, process engineering, nanotechnology, ITeS, and electronics. Q: Briefly tell us about the success stories achieved at the centre? Dr Jay: Success is a very subjective term. We measure our success mainly with the employment generated. A graduated company (Maa Kanak Biofertilizers) has developed biofertilizers with integrated pest management and integrated nutrient management solutions for the Odisha agro-climatic region, has been doing very good business in the State, and is slowly expanding to East India with a multi-crore turnover and has created employment for over 35 people. Another incubatee - Bionivid Technologies, a bioinformatics company has created employment for over 25 people. Success for us is also measured in terms of collaborations created. An incubatee, inDNA Life Sciences is collaborating with BGI China and Reach 100 in Australia, which is first of such a kind in India, to launch their genome-based diagnostics and solutions. In a recent meet up, the CEO of Maa Kanak Biofertilizers has expressed his interest in becoming an angel investor. We are in early stage discussions, targeting a total investment of INR 2 crore with a ticket size of INR 20-25 lakh, it gives us immense pleasure as our entrepreneurs are society conscious and philanthropic rather than being solely money-minded. Another graduated company called, Biologic Applications, has developed pre- and probiotic curd, which is gaining market traction. Looking at such success in Bhubaneswar in a short span time, 16 more start-ups have established their operation in our Incubator in the area of diagnostic, biomedical device, plant biotechnology, bioengineering and food biotechnology. To support large number of start-ups the KIIT management has developed a dedicated incubator of 60,000 sq ft built-up area with modern facilities. Q: Do you see a rise in the erection of number of biotech start-ups? Or is it dwindling? Dr Jay: The last decade in India has been very good in creating a positive vibration about start-ups in India, which has now resulted in attracting top students from IITs and IIMs, who are young researchers joining start-ups or starting one. This is a very encouraging trend in India, and I am confident that we will able to match other developed nations in the next decade as 'Make in India' campaign will really boost the start-up ecosystem. The Government of India, through its enterprise, BIRAC of DBT under the leadership of Dr Renu Swarup has taken a number of initiatives to create the necessary infrastructure and quality manpower. Similarly, National Science & Technology Entrepreneurship Development Board (NSTEDB) of DST, Govt of India, under the leadership of Mr H K Mittal has also established several biotechnology incubators and provided seed fund support schemes. Thus, it is definitely a growing trend. Q: Do you see any trends in the biotech start-ups climate? Dr Jay: Of late, there is an increasing trend of multi-disciplinary start-ups. Graduates from other fields like engineering, IT or management are starting biotech or healthcare start-ups, slowly filling in the voids that cannot be achieved individually. I have seen a clear shift among young scientists that, rather than getting into international research career, they are now preferring innovation path by taking up several innovative projects of Social Innovation Programme for Products Affordable & Relevant to Societal Health (SPARSH), Biotechnology Ignition Grant (BIG), Small Business Innovation Research Initiative (SIBRI) of BIRAC, Department of Biotechnology (DBT), and the Government of India. These schemes have brought new spark in the biotechnology start-up ecosystem. I can see the acceleration rate already, and five years down the line we will see large numbers of young start-ups in this area. Q: Where can Indian incubation centres improve on? Dr Jay: Biotechnology and Life Science incubation centres should work on retaining in-house pool of technical mentors for helping the start-ups in every step of proof-of-concept till validation. Incubators should talk frequently to the investors and VCs and convince them for possible investments. Improvement should be made with respect to de-risking the biotechnology sector. The multi billion dollar valuations and billion dollar investments that are routinely seen in the e-commerce sector are either non-existent or minimal in the biotechnology sector. Angels and VCs are bullish about the regulatory framework, which is hindering them to invest in biotechnology. However, we are seeing a rising trend, where in few players are recognizing the efforts of the sector. A move in this regard from the Government is the equity-based investment scheme - AcE fund. This would de-risk few of the stages and encourage VCs to invest in the Indian biotechnology sector. ]]> <![CDATA[Allergan to buy a Medtech firm, Oculeve]]> https://biospectrumindia.com/news/95/6151/allergan-to-buy-a-medtech-firm-oculeve.html https://biospectrumindia.com/news/95/6151/allergan-to-buy-a-medtech-firm-oculeve.html Tue, 07 Jul 2015 12:08:35 +0530 Allergan and Oculeve has announced that they have entered into an agreement under which Allergan will acquire Oculeve in an all-cash transaction. Under the terms of the agreement, Allergan will acquire Oculeve for a $125 million upfront payment and commercialization milestone payments related to Oculeve's lead development program OD-01. The agreement also includes the acquisition of an additional earlier-stage dry eye device development program. The acquisition of Oculeve adds novel, complementary dry eye development programs to Allergan's current eye care research and development programs, including OD-01, a non-invasive nasal neurostimulation device that increases tear production in patients with dry eye disease. Oculeve has completed four clinical studies of OD-01 to date in more than 200 patients, showing positive safety and efficacy of the device. Allergan plans to conduct two additional pivotal trials prior to FDA submission, which is expected in 2016 with potential commercial launch in 2017. "Allergan is committed to developing a broad range of innovations that help patients address dry eye," said Mr David Nicholson, executive vice-president, global brands Research and Development at Allergan. He added, "The OD-01 program has been shown to provide a strong safety and efficacy profile, and if approved, would provide an exciting new treatment option for patients that is complementary to our existing product offerings in this important treatment area." "Allergan's position and expertise in eye care will maximize the development and potential commercialization of the OD-01 technology," said Mr Michael Ackermann, president and CEO of Oculeve. He added, "I am extraordinarily appreciative and proud of the Oculeve team that has worked so hard to develop our exciting technology, and I am thrilled for us to partner with the Allergan team on the continued development, potential approval and availability of OD-01 to patients worldwide." The transaction is subject to the expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976. Pending approvals, Allergan anticipates closing the transaction in the third quarter of 2015. ]]> <![CDATA[Horizon Pharma to get the US patent]]> https://biospectrumindia.com/news/95/6153/horizon-pharma-to-get-the-us-patent.html https://biospectrumindia.com/news/95/6153/horizon-pharma-to-get-the-us-patent.html Tue, 07 Jul 2015 12:08:08 +0530 Horizon Pharma has announced that it has received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for the US patent application number 14/596,919 (US publication number 2015-0126607), entitled "Diclofenac Topical Formulation" that covers Horizon's US approved product PENNSAID (diclofenac sodium topical solution) two percent w/w (PENNSAID 2 percent). This Notice of Allowance concludes the substantive examination of the patent application and will result in the issuance of the US patent after administrative processes are completed. The US patent scheduled to issue from this application will expire in 2027. After issuance, Horizon plans to list the patent in the FDA's Approved Drug Products with Therapeutic Equivalence Evaluations, or Orange Book. This will be the tenth US patent to be listed in the Orange Book for PENNSAID two percent. The drug is a non-steroidal anti-inflammatory drug indicated for the treatment of pain of osteoarthritis (OA) of the knees. ]]> <![CDATA[Indian men at high risk of thyroid dysfunction:SRL Study]]> https://biospectrumindia.com/news/95/1642/indian-men-at-high-risk-of-thyroid-dysfunctionsrl-study.html https://biospectrumindia.com/news/95/1642/indian-men-at-high-risk-of-thyroid-dysfunctionsrl-study.html Tue, 07 Jul 2015 12:07:43 +0530 SRL Diagnostics, a leading global diagnostic chain recently conducted a three year long data mining survey (2012 - 2014) which revealed increasing numbers of urban men are detected with Thyroid disorders in the recent times. Thyroid disorders, which are most commonly associated with women, are affecting men as well with serious consequences leading to heart problems, mental health issues, Infertility etc. Hypothyroidism, categorized under the cluster of iodine deficient disorders (IDDs), is highly prevalent in India with one out of 10 people in the country being diagnosed with the condition. It has been estimated that about 200 million people suffer from thyroid disorders worldwide and amongst those 42 million are in India. As per Dr B R Das, president - Research and Innovation, mentor - Molecular Pathology and Clinical Research Service of SRL Diagnostics, "There is a significant need for reaching out and making people aware of the causes, symptoms, treatment and importance of testing for thyroid problems. SRL Diagnostic's in-house data analysis on thyroid tests assesses the nationwide abnormalities in test results in men residing in various cities that represent diverse geographic origin, occupation, socio-economic status and food habits." Thyroid diseases are different from other diseases in terms of their ease of diagnosis, accessibility of medical treatment, and the relative visibility that even a small swelling of the thyroid offers to the treating physician. Early diagnosis and treatment remain the cornerstone of management. Even as problems associated with abnormal production of thyroid hormones continues to grow significantly, awareness about the disease in the country among men remains shockingly low. Of the 14, 24,008 screened for the study by SRL, 22.68 per cent, of the total samples were found with abnormal TSH levels. The younger population within the age group of 31-45 years was at higher risk of thyroid dysfunction (30.33 percent of the samples) than the older population within the age group of 46-60 years (25.81 percent of the samples). The analysis showed the highest prevalence of the disease among men in the eastern zone of the country. East Zone had highest percentage of abnormality with 25. 2 percent while northern and western zone had 23.9 percent and 21.1 percent respectively. Among the four zones, southern India showed the lowest percentage of abnormality with 19.4 percent. A recent survey conducted by Indian Thyroid Society depicts awareness for the disease ranked ninth as compared to other common ailments such as asthma, cholesterol problem, depression, diabetes, insomnia and heart problem .The prevalence of hypothyroidism in the developed world is estimated to be about 4-5 percent. According to the survey, the disease is more prevalent between the age group of 46-54 years. The symptoms of the disease are often confused with other disorders, thus making thyroid one of the most under-diagnosed with no permanent cure disorders in India. However, with medication and proper treatment, thyroid can be controlled thereby helping patients to lead normal lives. The study findings call for an emphasis on active screening of endocrine function among patients at greater risk along with regular monitoring of thyroid status and dose adjustments to provide effective therapy in patients with established diagnosis. Thyroid abnormalities are diagnosed by measuring the status of thyroid hormones - serum FT3, FT4 and thyroid stimulating hormone [TSH]. ]]> <![CDATA[DST Conclave: India retains 3rd spot in nanotech publications]]> https://biospectrumindia.com/news/95/5227/dst-conclave-india-retains-3rd-spot-in-nanotech-publications.html https://biospectrumindia.com/news/95/5227/dst-conclave-india-retains-3rd-spot-in-nanotech-publications.html Tue, 07 Jul 2015 11:26:31 +0530 The union minister of science and technology, Dr Harsh Vardhan, has called upon scientific institutions to refocus their scientific pursuit to realize the dream of Prime Minister's national dreams of Swasth Bharat, Swatch Bharat and Digital India. Dr Harsh Vardhan was inaugurating a two days Conclave of the Department of Science and Technology (DST), government of India, at Hyderabad on July 07, 2015. He said that this conclave is a unique opportunity to introspect sincerely as to how much we can do to serve humanity by converting knowledge to solutions. The conclave has been organized to brainstorm on the achievements of the ministry and also set the future directions for implementing S&T based interventions for meeting the challenges faced by the country. Secretary, DST, Directors/Heads of Statutory Bodies, 21 Autonomous Institutions, Survey of India, National Atlas and Thematic Mapping Organisation and Programme Divisions of DST are participating in the conclave. The minister suggested that the autonomous institutions of the department should actively engage in fulfilling the National Agenda such as Swasth Bharat, Swatch Bharat, Digital India as outlined by the Prime Minister. He appealed to the scientific fraternity to provide their valuable inputs and vision for application of S&T based interventions to achieve global competence, focus on alleviating the sufferings of the common man and develop S&T based approach to fast forward the process of socio-economic development of the country. In his address Mr Y S Chowdary, minister of state for science and technology and Earth Sciences flagged some of the challenges faced by the country and called upon Scientists to give a thought for efficient utilization of our huge human resource through proper skilling so that this becomes an asset to the country. He suggested the scientific institutions to work in a network mode and connect R&D with the people. He also suggested the scientific institutions to prepare a blue print of the needs and potentials and come out with actionable programmes. Prof Ashutosh Sharma, secretary, DST presented an overview of the recent activities and achievements of the Department. He emphasized the role of DST in promotion of Basic Research on new and emerging areas which had led to the emergence of several new Science Ministries/Departments such as Environment and Forests, New and Renewable Energy, Biotechnology, Scientific and Industrial Research, Earth Sciences. He also mentioned that the autonomous institutions of DST are "Hot-Spots of knowledge" wherein R&D is being cultivated and nurtured in unique areas of science. He informed that over the global average of 4 percent in scientific publication, India has achieved 13 percent growth rate during last few years. India has achieved 3rd rank in the world in terms of scientific publications in the area of Nano Science and Technology largely due to efforts of Nano Mission of DST. He also emphasized to evolve mechanisms for faster technology commercialization. ]]> <![CDATA[Pharmexcil inaugurates Chennai office at Pharmac South 2015]]> https://biospectrumindia.com/news/95/7365/pharmexcil-inaugurates-chennai-office-at-pharmac-south-2015.html https://biospectrumindia.com/news/95/7365/pharmexcil-inaugurates-chennai-office-at-pharmac-south-2015.html Mon, 06 Jul 2015 15:22:36 +0530 With the objective of giving contract manufacturing a big push, to thrust the growth of the South Indian pharma industry and to boost pharma exports to Africa and ASEAN countries, the southern chapter of IDMA and Pharmexcil organized a two-day conference and exhibition in Chennai from July 3rd to 4th, 2015. At the event, Pharmexcil and IDMA - with the support of all other South Indian Pharmaceutical Associations - inaugurated the Chennai office of Pharmexcil and had organized a Buyer-Seller meet between the exhibitors and visiting drug importers. Pharmac South 2015 provided a broad scope to the 250 participating companies to increase their knowledge on new technologies in drug manufacturing; funding and investment options; entering into new strategic alliances with visiting foreign manufactures; and to gain knowledge through seminars on building brands and high performing sales team. Speaking at the event, S V Veeramani, President of IDMA, said, "As Tamil Nadu is fast growing in exports of pharma drug to countries like Sri Lanka and Africa, IDMA and Pharmexcil felt the need to launch an exclusive office of Pharmexcil in Chennai to support and guide the 350-pharma drug exporters in the southern part of India. Pharmac South 2015 is mainly organized with the objective to educate these pharma exporters on how to double their exports and at the same time maintain highest quality standards." Revealing some statistics at the inauguration function of the event, Dr V K Subburaj, Secretary, Dept. of Pharmaceuticals, Ministry of Chemicals and Fertilizers, said that India has become a prime destination for manufacturing of branded and generic medicines with a strong export element. It is estimated that around 40 per cent of the generic drugs in the US come from India and with Obamacare being introduced this figure is set to steadily rise further. He explained that India's pharmaceutical industry is 4th largest in world in terms of volume and ranks 13th in terms of value. The present turnover of the industry is Rs 2 lakh crore and it is expected to grow to Rs 4 lakh crore by 2020, with pharma exports contributing to Rs 1 lakh crore. Understanding the need for a strong policy on bulk drugs, Dr V K Subburaj, assured to the pharma companies that soon there would be an effective policy on bulk drug manufacturing, which will set global standards for production of quality and cost-effective drugs. He also assured that the Government will take appropriate initiatives in increasing the allocation of funds for R&D, upgradation of manufacturing equipments and setting high quality standards. Dr Subburaj believes that enforcing a strict regulatory system in bulk drug manufacturing will increase the quality of drug production, which inturn will help the export turnover multiply manyfold. Director of Drugs Control, Tamil Nadu, S. Abdul Khader, said, "This event has set a good platform to bring manufacturers and buyers to meet under one roof." He extended his assurance to the manufactures that the Tamil Nadu Government will bring in single-window clearance of essential drugs without any procedural delays. ]]> <![CDATA[Dr. Reddy's unveils new corporate brand identity]]> https://biospectrumindia.com/news/95/7132/dr-reddys-unveils-new-corporate-brand-identity.html https://biospectrumindia.com/news/95/7132/dr-reddys-unveils-new-corporate-brand-identity.html Fri, 03 Jul 2015 16:46:08 +0530 Dr. Reddy's Laboratories today announced the launch of its new visual identity and brand, that will guide its actions across the globe: Good Health Can't Wait.The company has also chosen a new corporate colour - Purple, which is associated with creativity and wisdom. According to the company release, the objective of the rebranding exercise is to derive a unifying, patient-centric approach, to meet new and daunting challenges that patients are facing. With the healthcare scenario changing rapidly, it is important to be driven by a common goal that adds value to every touch-point for patients and partners alike. The re-branding will be executed in two stages. In the first phase, the corporate brand has transitioned to the new identity. Phase two will see the new identity transitioning on to the company's product packaging. The existing logo and brand identity will remain in place and valid until changes that are pertinent to legal processes, documentation and other regulatory or statutory changes are complete. Commenting on the launch, Satish Reddy, Chairman - Dr. Reddy's Laboratories said, "Over 31 years, Dr. Reddy's has grown from a manufacturer of APIs into a multinational pharmaceutical brand of repute, with operations in over 25 countries. Throughout this journey, we have remained true to our core values, even as we continually transform to keep pace with the changing needs of our patients and partners. Our belief 'Good Health Can't Wait' lends new meaning to our core purpose of accelerating access to affordable and innovative medicines." ]]> <![CDATA[Biogen, AGTC partner to develop gene therapies in ophthalmology]]> https://biospectrumindia.com/news/95/6413/biogen-agtc-partner-to-develop-gene-therapies-in-ophthalmology.html https://biospectrumindia.com/news/95/6413/biogen-agtc-partner-to-develop-gene-therapies-in-ophthalmology.html Fri, 03 Jul 2015 12:08:05 +0530 Biogen and AGTC have announced a broad collaboration and license agreement to develop gene-based therapies for multiple ophthalmic diseases. The collaboration will focus on the development of a portfolio of AGTC's therapeutic programs, including both a clinical stage candidate and a pre-clinical candidate for orphan diseases of the retina that can lead to blindness in children and adults. The agreement also includes options for early stage discovery programs in two ophthalmic diseases and one non-ophthalmic condition, as well as an equity investment in AGTC by Biogen and a license agreement for manufacturing rights. "With this collaboration, we hope to advance gene therapies to open possibilities for patients who suffer from diseases that are well understood, but have no adequate treatment. AGTC is an exceptional partner to help us advance our gene therapy capabilities by targeting diseases of the eye, an organ that provides an ideal setting for the localized, selective delivery of gene-based therapies," said Dr Olivier Danos,senior vice-president, cell and gene therapy at Biogen. "We expect this collaboration will further validate our novel adeno-associated virus (AAV) gene therapy platform and support the development of new therapies that may allow for transformative treatments for these rare inherited eye diseases and other clinical indications," said Ms Sue Washer, president and CEO of AGTC. She added, "Biogen's significant commitment to advancing gene therapies and demonstrated success in developing innovative therapies to treat complex diseases, combined with our proprietary manufacturing technology and extensive gene therapy experience, makes this an ideal partnership." The lead development programs in the collaboration include a clinical candidate for X-linked Retinoschisis (XLRS) and a pre-clinical candidate for the treatment of X-Linked Retinitis Pigmentosa (XLRP). XLRS, a disease affecting young males beginning during the teenage years, can lead to serious complications such as vitreous hemorrhage or retinal detachment during adulthood. XLRP usually causes night blindness by the age of ten and progresses to legal blindness by an individual's early forties. Both conditions represent significant unmet needs that may be addressed by replacing the single, faulty gene causing each disease. Biogen will make an upfront payment in the amount of $124 million to AGTC, which includes a $30 million equity investment in AGTC at a price equal to $20.63 per share and certain prepaid research and development expenditures. Biogen will be granted a license to the XLRS and XLRP programs and the option to license discovery programs for three additional indications at the time of clinical candidate selection. Under the collaboration, AGTC is eligible to receive upfront and milestone payments exceeding $1 billion. This includes up to $472.5 million collectively for the two lead programs, which also will carry royalties in the high single digit to mid-teen percentages of annual net sales. In addition, Biogen will make payments up to $592.5 million across the discovery programs, along with royalties in the mid single digits to low teen percentages of annual net sales. ]]> <![CDATA[Lupin acquires Biocom in Russia]]> https://biospectrumindia.com/news/95/6165/lupin-acquires-biocom-in-russia.html https://biospectrumindia.com/news/95/6165/lupin-acquires-biocom-in-russia.html Fri, 03 Jul 2015 12:06:26 +0530 Lupin has announced the acquisition of 100 percent equity stake in ZAO "Biocom" in Russia, subject to certain closing conditions. The acquisition marks Lupin's foray into the Russian pharmaceutical market which recorded $13.82 billion approx. (RUB 765 billion) in sales, placing it as one of the Top 10 pharmaceutical markets in the world in 2014 (IMS Health). Established in 1991, Biocom is a fast growing generic pharmaceutical company with a major focus on therapies such as cardiovascular, central nervous system and antimicrobials for systemic use and also does contract manufacturing and secondary packaging. Biocom operates a modern European GMP compliant plant and was also one of the first Russian pharmaceutical manufacturing companies to receive an approved manufacturer status from the World Health Organization (WHO) in 2013. Commenting on the acquisition, Ms Vinita Gupta, CEO, Lupin said, "We are excited about our entry into the Russian market through Biocom. Russia is an attractive market and this acquisition will also enable our expansion into neighboring markets as well as other Eastern European markets in the future." Mr Aleksandr Sergeyev, Biocom's executive officer, said, "I am delighted with Biocom's association with Lupin. Having found, built and developed Biocom together with Mr Igor Rudinskiy for so long, I firmly believe that the future and growth of Biocom would be best handled by the management and technology expertise that Lupin brings to table. I wish Biocom and Lupin the very best in their future endeavors." ]]> <![CDATA[Cabinet approves national policy for skill development & entreprenuership ]]> https://biospectrumindia.com/news/95/7682/cabinet-approves-national-policy-for-skill-development-entreprenuership-.html https://biospectrumindia.com/news/95/7682/cabinet-approves-national-policy-for-skill-development-entreprenuership-.html Fri, 03 Jul 2015 12:05:49 +0530 The union cabinet chaired by the Prime Minister, Mr Narendra Modi, on June 02, 2015 gave its approval for the India's first integrated National Policy for Skill Development and Entrepreneurship 2015. The Policy acknowledges the need for an effective roadmap for promotion of entrepreneurship as the key to a successful skills strategy. The Vision of the Policy is "to create an ecosystem of empowerment by Skilling on a large Scale at Speed with high Standards and to promote a culture of innovation based entrepreneurship which can generate wealth and employment so as to ensure Sustainable livelihoods for all citizens in the country". To achieve this Vision, the Policy has four thrust areas. It addresses key obstacles to skilling, including low aspirational value, lack of integration with formal education, lack of focus on outcomes, low quality of training infrastructure and trainers, etc. Further, the Policy seeks to align supply and demand for skills by bridging existing skill gaps, promoting industry engagement, operationalising a quality assurance framework, leverage technology and promoting greater opportunities for apprenticeship training. Equity is also a focus of the Policy, which targets skilling opportunities for socially/geographically marginalised and disadvantaged groups. Skill development and entrepreneurship programmes for women are a specific focus of the Policy. In the entrepreneurship domain, the Policy seeks to educate and equip potential entrepreneurs, both within and outside the formal education system. It also seeks to connect entrepreneurs to mentors, incubators and credit markets, foster innovation and entrepreneurial culture, improve ease of doing business and promote a focus on social entrepreneurship. ]]> <![CDATA[Zydus receives FDA nod for Morphine Sulfate Tablets]]> https://biospectrumindia.com/news/95/7453/zydus-receives-fda-nod-for-morphine-sulfate-tablets.html https://biospectrumindia.com/news/95/7453/zydus-receives-fda-nod-for-morphine-sulfate-tablets.html Thu, 02 Jul 2015 15:09:09 +0530 Zydus Group has received the final approval from the United States Food and Drug administration (USFDA) to market its Morphine Sulfate ER Tablets, used in the treatment of chronic pain or cancer related pain. The Tablets will be manufactured by Nesher Pharmaceuticals, located at St.Louis, USA, the company said in afiling to the BSE. Nesher Pharmaceuticals is a subsidary of Zydus Pharmaceuticals. ]]> <![CDATA[11th Indo-Australian biotech conference to be held soon]]> https://biospectrumindia.com/news/95/3123/11th-indo-australian-biotech-conference-to-be-held-soon.html https://biospectrumindia.com/news/95/3123/11th-indo-australian-biotech-conference-to-be-held-soon.html Thu, 02 Jul 2015 14:06:00 +0530 The registrations are open for the Indo-Australian international conference which will host reputed scientists from India and Australia. This is in the background of growing research linkages between Australia and India, thereby creating new opportunities for collaboration and exchange. Those links will be enhanced by the 11th Biennial Indo-Australian Biotechnology Conference, to be held on the 7-8 of September at the Westmead Millennium Institute's new state-of-theart medical research facility in Sydney. Leading scientists from India and Australia will speak about their research into the immunology of infection, cancer and auto-immune diseases and new approaches to the development of vaccine. Among the keynote speakers are Prof Ian Fraser AC, Translational Research Institute, Brisbane who would be speaking on immunology of human papillomavirus and cervical cancer. Prof. V Nagaraja, Indian Institute of Science, Bangalore - Immunology of tuberculosis. ]]> <![CDATA[Akaal Pharma, GVK BIO extend partnership]]> https://biospectrumindia.com/news/95/6164/akaal-pharma-gvk-bio-extend-partnership.html https://biospectrumindia.com/news/95/6164/akaal-pharma-gvk-bio-extend-partnership.html Thu, 02 Jul 2015 13:11:33 +0530 GVK BIO has announced an extended collaboration with the Australia-based clinical stage biopharmaceutical company, Akaal Pharma, for the scale-up of its novel topical AKP-11 ointment to support Phase II clinical study in psoriasis. GVK BIO's Formulation Development business unit in Bengaluru has developed a robust and scalable process for novel topical AKP-11 ointment. GVK BIO plans to support clinical studies of Akaal Pharma's topical psoriasis drug by providing clinical supplies, manufacturing and analytical support. Discussions are also on-going to work towards exploring appropriate commercialization packaging and various formulations for the topical use in other inflammatory diseases. Mr Seetharaju Gembali, senior vice-president, Formulation R&D of GVK BIO, said, "Strengthening of our partnership with Akaal Pharma is testimonial to our expertise in the Formulation Development and we look forward to working with other clients." Dr Dale Dhanoa, CEO of Akaal Pharma, said, "We have had a very efficient CRO relationship with GVK for our clinical trials supplies support due to GVK BIO's experience, capabilities and facilities. We are excited to advance our First-in-Class multimodal acting topical drug candidate AKP-11 into Phase 2 stage of clinical development for the treatment of psoriasis. There are several other inflammatory diseases that we are targeting with our clinical compound and are currently exploring various formulations for its topical applications." ]]> <![CDATA[Marksans Pharma acquires Time-Cap Laboratories]]> https://biospectrumindia.com/news/95/6152/marksans-pharma-acquires-time-cap-laboratories.html https://biospectrumindia.com/news/95/6152/marksans-pharma-acquires-time-cap-laboratories.html Thu, 02 Jul 2015 12:27:53 +0530 Mumbai-based drug maker Marksans Pharma has announced that its US subsidiary has bought 100 percent stake in New York-based Time-Cap Laboratories. Financial details of the deal were not disclosed. According to the company, the acquisition increases its presence in the US market. "Time-Cap offers Marksans an ideal platform to expand its operation in the US. The strategic acquisition helps Marksans to expand its manufacturing capabilities along with product portfolio and penetration in the US," said Mr Mark Saldanha, managing director and chief executive officer, Marksans Pharma, in a statement. ]]> <![CDATA[ICAR research must be directed at farmer's benefits]]> https://biospectrumindia.com/news/95/7338/icar-research-must-be-directed-at-farmers-benefits.html https://biospectrumindia.com/news/95/7338/icar-research-must-be-directed-at-farmers-benefits.html Thu, 02 Jul 2015 11:51:20 +0530 Dr Sanjeev Kumar Balyan visited ICAR-National Institute of Research on Jute and Allied Fibre Technology (NIRJAFT), Kolkata recently. The agriculture minsiter addressed a gathering of Directors and In-Charges of ICAR institutes in and around Kolkata. Dr Balyan, in his address, mentioned the need for more proactive research and for that the mandate of ICAR institutes should be relooked to provide better quality service to the farmers for achieving more productivity using minimum resources rather than generation of scientific knowledge only. He emphasized that time is changing so development of machinery or technology must suit the requirements of the farmers. Directors of ICAR Institutes briefed Minister on the research priorities, achievements and scope of work of the respective institutes. Scientists, Technical and Administrative staff of ICAR institutes participated in the meeting. (Source: ICAR-NIRJAFT, Kolkata) ]]> <![CDATA[Global biosimilars market value could hit $55 bn by 2020]]> https://biospectrumindia.com/features/95/4346/global-biosimilars-market-value-could-hit-55-bn-by-2020.html https://biospectrumindia.com/features/95/4346/global-biosimilars-market-value-could-hit-55-bn-by-2020.html Wed, 01 Jul 2015 14:01:05 +0530 The global biosimilars market value is expected to reach $20 billion by the end of 2015 and could hit $55 billion by 2020, with growth primarily driven by a promising pipeline in active development and government efforts to reduce healthcare spending, according to business intelligence provider GBI Research. The company's latest CBR pharma report states that biologics currently account for between 17-20 percent of the pharmaceutical arena, with a value of nearly $200 billion, and these products may replace 70 percent of chemical drugs in the next two decades. Mr Sumith Ladda, analyst for GBI Research, says the 30 percent to 50 percent reduction in biosimilar prices compared with branded biologics could lead to considerable savings in healthcare expenditure. He comments: "There are currently 642 biosimilar trials being conducted, with 146 unique molecules. Biosimilars are most focused on oncology therapy, with a 36 percent share, while immunology treatment comprises 21 percent of the pipeline, meaning these two segments account for more than half of the total trials. "Historically, simple proteins, such as filgastrim and epotien, were the prime targets of biosimilar development, but the focus has now shifted to complex monoclonal antibodies (mAbs), as there are numerous blockbuster mAbs going off-patent." While a regulatory framework for biosimilars has been established in all major markets, some aspects, such as interchangeability, naming conventions and extrapolation across indications, need to be harmonized. Mr Ladda continues: "The European Medicines Agency has the most robust and longest-standing guidelines for biosimilars. Countries such as Japan, China, and South Korea have developed guidelines similar to these. "The US Food and Drug Administration finalized guidelines for biosimilars in 2014 and approved its first biosimilar, Zarxio, on March 6, 2015. This marks the entry of biosimilars in the US, and has increased industry confidence in the country's biosimilars market." ]]> <![CDATA[Lucknow biotech park to be a centre of excellence]]> https://biospectrumindia.com/news/95/7331/lucknow-biotech-park-to-be-a-centre-of-excellence.html https://biospectrumindia.com/news/95/7331/lucknow-biotech-park-to-be-a-centre-of-excellence.html Wed, 01 Jul 2015 12:49:26 +0530 To pursue innovative research in areas of mutual interest and develop much needed human resource in field of biotechnology and allied disciplines, Biotech Park (BTP), Lucknow and Babasaheb BBAU, Lucknow entered into memorandum, of understanding (MoU) on May 18, 2015. Both the institutions will promote and develop entrepreneurial environment through training and consultancy aimed at encouraging and enabling small businesses by the young scientists and technologists. Both the partners will undertake collaborative human resource development programmes for students and technologists; training of trainers, biotechnology management development programmes, biotechnology related research, innovation and skill development activities, and programs to impart skills in IPRs and expertise in regulations and norms of regulatory authorities such as GMP, GLP, etc. Biotech Park will be a Centre of Excellence of BBAU. The BTP and BBAU will share their expertise and resources in various programs. Joint certification of HRD programs being run by BTP will also be possible and the students clearing the biotechnology finishing school will be able to get a joint certificate. The institutions will also jointly write proposals for funding for translational research, training and publish additional data on entrepreneurship development. ]]> <![CDATA[Strengthening health sector is govt's top priority, assures JP Nadda]]> https://biospectrumindia.com/news/95/7134/strengthening-health-sector-is-govts-top-priority-assures-jp-nadda.html https://biospectrumindia.com/news/95/7134/strengthening-health-sector-is-govts-top-priority-assures-jp-nadda.html Wed, 01 Jul 2015 11:03:00 +0530 "The government places the highest priority to strengthening the health sector in the country. There is the highest level of political commitment for this" stated Mr JP Nadda, minister for health and family welfare stated this while delivering the keynote address at the Health and Immunisation Conference organised by the CII, at New Delhi on June 30, 2015. Mr Nadda stated that the National Health Mission (NHM), comprising of National Rural Health Mission (NRHM) and the National Urban Health Mission (NUHM), aims towards providing accessible, affordable, accountable, and effective primary healthcare facilities, especially to the rural population of the country with a particular emphasis on poor and vulnerable sections of the population. It encompasses programmes to cater to requirements of pregnant women, children and communicable as well as non-communicable diseases. He added that reducing maternal and child mortality are the foremost goals of National Health Mission, which has significantly fostered plans for child health in decentralised manner up-to district level. Steady progress in curbing child deaths has been achieved. India's Under 5 Mortality Rate declined from 126 per 1,000 live births in 1990 to 49 per 1,000 live births in 2013, the minister informed. The health minister said that Mission Indradhanush has been able to fill in the gap in fully immunising children who have been left unvaccinated or are partially vaccinated under the routine immunization program. Three rounds have been completed and the fourth round will start from 7th July, the health minister stated. The Minister added that of all the methods of preventing the under-5 mortality, immunization is one of the most cost-effective public health interventions for protecting children from life threatening conditions, which are preventable. He stated that during these immunization rounds, 56.6 lakh children have been vaccinated and a total of 14.4 lakh children were fully vaccinated. Also, a total of 15.7 lakh pregnant women were vaccinated with tetanus toxoid vaccine during these three rounds. Mr Nadda also stated that cold chain network in the country has been the backbone of the Immunization Programme to ensure that right quantity/ quality of vaccines reach the target population. The health minister sought the participation and partnership of the private sector in providing accessible, affordable and cost effective health care services in the country to complement the efforts of the government. He stated that with the support of the private sector, we will be able to further strengthen the Cold Chain and Supply Management system in the country. Also present at the function were Dr Naresh Trehan, chairman, CII Committee on Healthcare; Mr Jamshyd Godrej, MD and chairman, Godrej and Boyce; and Prof. Ricjard Feachem of University of California, Berkely. ]]> <![CDATA[Suven secures three product patents ]]> https://biospectrumindia.com/news/95/3201/suven-secures-three-product-patents-.html https://biospectrumindia.com/news/95/3201/suven-secures-three-product-patents-.html Wed, 01 Jul 2015 10:20:17 +0530 Suven Life Sciences (Suven) announces the grant of one product patent each from Israel (218525), Japan (5714729) and South Africa (2013/09100), corresponding to their New Chemical Entities (NCEs) for the treatment of disorders associated with Neurodegenerative diseases. The granted claims of the patents include the class of selective 5-HT compounds discovered by Suven and are being developed as therapeutic agents and are useful in the treatment of cognitive impairment associated with neurodegenerative disorders like Alzheimer's disease, Attention deficient hyperactivity disorder (ADHD), Huntington's disease, Parkinson and Schizophrenia. With these new patents, Suven has a total of six (6) granted patents from Israel, seventeen (17) granted patents from Japan and twenty (20) granted patents from South Africa. These granted patents are exclusive intellectual property of Suven and are achieved through the internal discovery research efforts. Products out of these inventions may be out-licensed at various phases of clinical development like at Phase-I or Phase-II. "We are very pleased by the grant of these patents to Suven for our pipeline of molecules in CNS arena that are being developed for cognitive disorders with high unmet medical need with huge market potential globally," said Mr Venkat Jasti, CEO of Suven. ]]> <![CDATA[NACO snips import duties on AIDS drugs]]> https://biospectrumindia.com/news/95/7117/naco-snips-import-duties-on-aids-drugs.html https://biospectrumindia.com/news/95/7117/naco-snips-import-duties-on-aids-drugs.html Wed, 01 Jul 2015 09:10:00 +0530 In an effort to cut prices and battle shortage of supply in its on-going national program to fight AIDS, India has scrapped customs import duties for drugs and test kits used to treat the disease. Nearly a third of India's 2.1 million AIDS sufferers depend on state-run distribution centers for their drugs and there has been acute shortage in supply, said the country's National AIDS Control Organization. The Central Board of Excise and Customs recently issued the notice to scrap import duties and this will help make raw material import cheaper, which can be used to increase the production of AIDS drugs and testing kits. Mr BB Rewari of the National AIDS Control Organization (NACO) said to a news agency, "The exemption applies to certain first-line and second-line antiretroviral drugs used to treat adults and children, as well as to certain diagnostic kits and equipment that are used by NACO." ]]> <![CDATA[Pharma sector to get Rs 500 crore boost]]> https://biospectrumindia.com/news/95/6373/pharma-sector-to-get-rs-500-crore-boost.html https://biospectrumindia.com/news/95/6373/pharma-sector-to-get-rs-500-crore-boost.html Wed, 01 Jul 2015 09:07:00 +0530 In a bid to provide further impetus to the burgeoning pharma industry, the government has announced plans to set up a Rs 500-crore venture capital fund to provide cheaper loans to entities looking to establish or upgrade manufacturing facilities. In line with the government's agenda of promoting 'Make in India' the ministry said that it is working on various proposals, including single window clearance for drug approvals, to rejuvenate the local pharma sector and make medicines more affordable. Mr Anath Kumar, Chemicals and Fertilisers Minister, had also said that the government is planning to approve six pharma parks this year at an estimated investment of Rs 180 crore to promote pharmaceuticals manufacturing. The steps were elaborated in a report released by the Department of Pharmaceuticals (DoP). In its report the task force had said the DoP may come up with seed capital and facilitate funding with other financial institutions for the medium and small scale pharmaceuticals industry. The panel in the report titled 'Recommendations of the Task Force on Enabling Private Sector to lead the growth of Pharmaceutical Industry', has said DoP may come up with a pharmaceutical specific venture fund, for channelising public resources into drug design and discovery. The department is also working on all other proposals including providing soft loans and interest subsidy to the industry as mentioned in the report of the task force. The task force also suggested that DoP may launch a scheme for giving financial assistance in the form of soft loan or interest subsidy for upgradation of selected manufacturing facilities to the industry. ]]> <![CDATA[Ensuring rural health must be a priority for Digital India campaign: ASSOCHAM ]]> https://biospectrumindia.com/news/95/6623/ensuring-rural-health-must-be-a-priority-for-digital-india-campaign-assocham-.html https://biospectrumindia.com/news/95/6623/ensuring-rural-health-must-be-a-priority-for-digital-india-campaign-assocham-.html Tue, 30 Jun 2015 14:56:59 +0530 As one of the immediate possible deliverables to Prime Minister Mr Narendra Modi's Digital India programme, an ASSOCHAM sectoral Paper has suggested Tele-medicine be reached to a vast population of the country which is still not covered with the basic health amenities. The key issues which can make the programme a big success would be costs and adequate availability of Internet bandwidth, the paper has said. With 68 percent of India's people living in rural areas, telemedicine is seen as a means of improving the quality of rural healthcare. In countries like India, the national healthcare systems are still struggling to deliver affordable access to healthcare to all of their citizens. With limited resources and much of the population living in remote rural areas, Telemedicine has the potential to revolutionize the delivery of healthcare in the country, the paper said. ''For telemedicine to be widely implemented, it has to be profitable to both; vendors and patients. Bandwidth costs, training and maintaining personnel at the point of care centre increase costs while confidence of the patient is low when the doctor untrained in tele-health attends to them," the ASSOCHAM Paper noted. The Chamber Secretary General Mr D S Rawat said, "Reaching health to the rural areas by leveraging the Prime Minister's ambitious Digital India Progamme would be one of its major measurable deliverables". Telemedicine has huge potential in India because of the severe shortage of doctors, especially in rural areas; high patient volumes; widespread availability of mobile networks; rapid growth in the availability of low-power, hand-held medical monitoring devices, and the shift away to a networked tele-enabled system. However, enough availability of Internet speed via bandwidth remains an area of concern. Even though low-cost telemedicine applications have proven to be feasible, clinically useful, these applications are not being adopted on a significant scale due to a variety of barriers. "Telemedicine usage is limited in scale in the country. Urgent action is therefore needed to break down barriers to the widespread adoption of the technology in healthcare. These barriers include regulatory hurdles, in particular clarifying the legislative environment relating to health data privacy and security and personal identity regulations", the paper said. A lack of computer literate workers with expertise in managing computer services, combined with the lengthy process required to master computer-based peripheral medical instruments can hinder the adoption of telemedicine in the country. ]]> <![CDATA[Hilleman Labs reports success in preclinical trials of Hib vaccine]]> https://biospectrumindia.com/news/95/7312/hilleman-labs-reports-success-in-preclinical-trials-of-hib-vaccine.html https://biospectrumindia.com/news/95/7312/hilleman-labs-reports-success-in-preclinical-trials-of-hib-vaccine.html Tue, 30 Jun 2015 14:53:57 +0530 The unique formulation derived from the ongoing research will not only bring down the cost of the vaccine, but will also provide a scalable platform for commercial manufacturing. This break-through research is another milestone achievement for Hilleman Laboratories with a vision to bridge the immunization gap. Speaking on this new development Dr Davinder Gill, CEO, Hilleman Laboratories mentioned, "Capsular polysaccharide conjugates of Hib are important components of several mono-or multivalent vaccines for children. However, the access to needy people is limited due to the relative high cost of the Hib vaccine. This new formulation will be a step towards developing a cost-effective and a more immunogenic vaccine. It is an encouraging breakthrough in bridging the gap and making Hib vaccine accessible and affordable." "A strategic three-step approach was used to identify the efficacy of polysaccharide in preparing a vaccine for Hib. Our original research published in the journal Vaccine shows that when the length of the polysaccharide was optimized, it dramatically improved immunogenicity in preclinical models, thus making it more powerful and effective. It was also found that the new formulation was 4 to 10 times more potent when compared to the existing licensed vaccines," added Dr Manoj Kumar Chhikara, Head of the Conjugate Vaccines R&D program at Hilleman Labs. Hib is a deadly bacterium that causes severe diseases like pneumonia and meningitis, which are the leading causes of child deaths in India, accounting for nearly 20% of the global death figures. Hib capsular polysaccharides (Hib-PRP)arepoorly immunogenic in children less than two years of age and require conjugation to a protein carrier.Moreover the Hib conjugate vaccine, which plays a vital role in national immunization programs and also forms a main part of the pentavalent vaccine, is the costliest component and hence developing countries such as India can benefit from more cost effective formulations. The new conjugate vaccine developed by Hilleman Laboratories is a more immunogenic preparation of Hib capsular polysaccharide (PRP)-tetanustoxoid (TT) conjugates using optimized PRP chain length and conjugation conditions. This new and unique cost-effective formulation developed by the company will significantly reduce the cost of Hibvaccine, which in turn, will help in reducing the market price of the pentavalent vaccine, thus making it accessible to a larger number of people. This will definitely have a larger economic impact on the public health system and subsequently bring down the expenditure in the system. "We have already completed the preclinical immunogenicity trial phase which has shown predictive results. Our next step now would be to look at collaboration with like-minded stakeholders who can work together towards cost effective solutions with the aim of bridging existing gaps in a significant way" said Dr. Gill. ]]> <![CDATA[Karnataka State: Asia's hottest biotech hub]]> https://biospectrumindia.com/features/95/7927/karnataka-state-asias-hottest-biotech-hub.html https://biospectrumindia.com/features/95/7927/karnataka-state-asias-hottest-biotech-hub.html Tue, 30 Jun 2015 12:51:00 +0530 India as a country ranks as the second most favored biotech destination next to China in the Asian continent. The Southern State of Karnataka in India has always been in the forefront of technological advancements in the global scientific arena. Notably the city of Bangalore, usually dubbed as India's Silicon Valley, has been crowned as the thriving hot bed for Information Technology and Biotechnology sector. Karnataka is a host to almost 60 percent of all biotechnology companies in India, followed by other States including Maharashtra, Andhra Pradesh and Tamil Nadu. Most of these companies have set up their R&D base in Karnataka, thereby attracting billions of dollars' worth investments every year. Bangalore is also a teeming place for India's best innovative biotech startups. In fact, Karnataka recorded the highest R&D spend in Southern India than any other State. The State also boasts of having strong research base, industry-academia nexus, top universities and institutes tie-ups, highly skilled workforce, robust infrastructure, raining FDIs, industry associations, and the government's supportive policy framework for prominently establishing Biotechnology in the State. Here is an exclusive peek into the State's world-class, state-of-the-art Biotech Parks. Helix Biotech Park in Bangalore With a whopping investment of INR 350 crore, Helix Biotech Park in Bangalore is a joint initiative between the department of IT, BT, S&T and Alexandria Real Estate Equities, USA. The park will be known as Alexandria Knowledge Park. Spread over 52 acres, the park aims to support biotech units with common infrastructure. The biotech incubator is spread over 10-15 acres in the park. The park will offer incubation facility, lab and commercial space, common instrumentation facility, a business center, commercial and recreational areas, high-end computing facility, pilot plant, medical sample repository, and a gene bank. Agri-Biotech Park in Dharwad In 2010, erecting an agri-biotech park in the District of Dharwad was proposed by Karnataka State with an investment of INR 80 crore, employing about 5000 workforce. Spain's Savaia Biotech and University of Massachusetts, USA, together are involved in the development of the park. The park will be built in 30 acres of land at the University of Agricultural Sciences-Dharwad (UAS), Karnataka. The park would be a centre for agriculture R&D, gene construction and pest management. Also transgenic plants of various crops is planned to be cultivated at the park. Neutraceutical and Phytopharmaceutical Park (N2P2) in Mysuru The park is planned with an investment of INR 103 crore, employing 5000 people. The park will pioneer in various R&D in the areas of nutrition and phytopharmaceuticals or medicinal plants. Animal House (Vivarium) in Bidar The Animal House (Vivarium) is upcoming in the District of Bidar in Karnataka, with an investment of INR 40 crore. It is expected to provide employment to over 3000 professionals. Standing on 20 acres of land, the centre will be a hub for conducting R&D in disease diagnosis, vaccine production, bioinformatics, embryo transfer, and stem cell techniques. Marine Biotech Park in Mangalore In 2010, the proposal to set up Marine Biotech Park in the District of Mangalore, Karnataka, was put forth, with an initial investment of INR 60 crore, offering employment to more than 3000 workers and professionals. ]]> <![CDATA[Dr Reddy's recalls two generic drugs in US]]> https://biospectrumindia.com/news/95/6783/dr-reddys-recalls-two-generic-drugs-in-us.html https://biospectrumindia.com/news/95/6783/dr-reddys-recalls-two-generic-drugs-in-us.html Tue, 30 Jun 2015 12:48:00 +0530 Dr Reddy's Lab is recalling two drugs used to treat seizure and hypertension from the US market. The company claimed that this is part of its precautionary measures and investigations have been initiated on the recall. According to The Financial Express report, the recall includes Divalproex Sodium extended-release tablets, 250 mg of 100 count (7,479 units) and 500 count bottles (2,544) units on the ground of "failed dissolution specifications, exceeded specification at the 9-hour time point". The drug is being recalled under the "class-II" classification. This classification is a situation in which the use of or exposure to a violative product may cause a temporary or medically reversible adverse health consequences or in which the probability of serious adverse health consequences is remote. Both the drugs are manufactured at the company's Bachupally facility in Hyderabad. The company had launched Divalproex in US in August, 2013 and Amlodipine Besylate and Atorvastatin Calcium tablets were launched in June last year. Similarly, the company has initiated the recall of some lots of Amlodipine Besylate and Atorvastatin Calcium tablets of various strengths in 30-count and 90- count bottles. The reason for recall was cited as subpotent. The recall of these tablets is being made under "class-III" classification which means a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. Amlodipine Besylate and Atorvastatin Calcium tablets are used to treat high blood pressure (hypertension) or chest pain (angina). ]]> <![CDATA[Roche launches a new diagnostic test]]> https://biospectrumindia.com/news/95/6340/roche-launches-a-new-diagnostic-test.html https://biospectrumindia.com/news/95/6340/roche-launches-a-new-diagnostic-test.html Tue, 30 Jun 2015 11:29:20 +0530 Roche has announced that its improved CARDIAC point-of-care Troponin T test for the cobas h 232 system is now available for countries accepting the CE Mark. The test allows healthcare professionals to identify patients with a suspected acute myocardial infarction (AMI), with greater accuracy, in just 12 minutes. This hand-held, point-of-care diagnostic system requires no sample preparation. Therefore, it can be used in places where heart attack patients are often seen first, such as in an ambulance, emergency room, or a primary care/general practitioner's office. The additional benefit of the improved test is that it is a quantitative test with higher accuracy (40-2000ng/L), making it possible to measure Troponin T levels â‰¥ 50ng/L, to rule-in patients with a suspected AMI and triage them effectively. This approach is endorsed by the preHAP clinical study, which showed that pre-hospital patients with a suspected AMI and a POC Troponin T â‰¥ 50ng/L had a 3-10 times higher long-term mortality risk. "Point-of-care diagnostics solutions play an integral role in an effective, sustainable healthcare, and their importance will further increase. The introduction of this improved test enables health care professionals to make earlier and more accurate interventions to save patients' lives," said Mr Roland Diggelmann, chief operating officer, Roche Diagnostics Division. Based on the test results, high risk patients may immediately be sent directly to a cardiac catheterization laboratory, where diagnostic imaging equipment can visualize the arteries of the heart and allow health care professionals to make the appropriate interventions. Lower risk patients can be sent to the hospital ward for further investigation. This approach helps save time, costs and potentially lives by reducing the time to correct treatment; facilitating the direct admission of patients to hospitals with the necessary testing equipment. "Portable, accurate and easy-to-use, the CARDIAC point-of-care Troponin T test allows frontline healthcare providers to quickly make confident decisions where to send patients for treatment", said Mr Jean-Claude Gottraux, head, Roche Professional Diagnostics. The CARDIAC point-of-care Troponin T test is standardized and compatible with central lab testing. After initial POC testing to diagnose patients in the ambulance (or GP's office), it can then be combined with a later test using the Elecsys cardiac Troponin T high-sensitive (cTnT-hs) test, at the central laboratory in a hospital. This means Roche can offer a diagnostic solution that covers from the assessment of pre-hospital and hospital patients, with a suspected AMI, to the treatment decision. ]]> <![CDATA[Novartis to acquire Spinifex Pharmaceuticals ]]> https://biospectrumindia.com/news/95/6338/novartis-to-acquire-spinifex-pharmaceuticals-.html https://biospectrumindia.com/news/95/6338/novartis-to-acquire-spinifex-pharmaceuticals-.html Tue, 30 Jun 2015 10:56:52 +0530 Novartis has announced that it has entered into an agreement to acquire Spinifex Pharmaceuticals, a US and Australia-based, privately held development stage company, focused on developing a peripheral approach to treat neuropathic pain such as EMA401, a novel angiotensin II Type 2 receptor (AT2R) antagonist. "Neuropathic pain is a chronic and debilitating condition with high unmet need. EMA401 could provide a novel, differentiated treatment approach to provide relief for patients and healthcare providers worldwide," said Mr David Epstein, Head of Novartis Pharmaceuticals. Positive results from Spinifex's Phase II clinical trial of EMA401 in post-herpetic neuralgia, a painful condition that develops in some people following herpes zoster (shingles), have been published in The Lancet, showing its efficacy. No central nervous system side effects or any serious adverse events have been observed in the study. Financial terms of the transaction were not disclosed. ]]> <![CDATA['Innovation in emerging markets is not all about cost reduction']]> https://biospectrumindia.com/news/95/4374/innovation-in-emerging-markets-is-not-all-about-cost-reduction.html https://biospectrumindia.com/news/95/4374/innovation-in-emerging-markets-is-not-all-about-cost-reduction.html Mon, 29 Jun 2015 15:29:00 +0530 That's according to a new report, which says innovation and technology will be important differentiators as pharma organizations try to drive growth in developing countries. The report summarizes the findings of a Cambridge Consultants. The product design and development firm brought together senior personnel from both Indian and multinational pharma companies to debate whether emerging markets can be an opportunity to drive sustainable growth. The consensus was that the term 'emerging markets' covers nations in parts of Africa, the Middle East and South East Asia, as well as the more traditional countries of Brazil, Russia, India and China. But all the delegates said emerging markets cannot be grouped into a single cluster to chalk out common strategies. Clustering markets around parameters such as regulatory pathways or therapeutic applications was considered the best approach. "Emerging markets are facing rapid growth of chronic 'Western' diseases like diabetes, hypertension, chronic respiratory problems, cancer, heart disease and neurological disorders," said Mr Ambuj Jain, India general manager, Cambridge Consultants. "In some cases, conditions like diabetes are turning into near-epidemic situations. In India, for example, the prevalence of diabetes and cancer is projected to rise by 25-40% over the next 10 years. This shift gives pharma companies an opportunity to market their global products in emerging markets, backed by tested 'go-to-market' strategies and operating models. The report says key barriers which need to be addressed in many emerging markets are the affordability and accessibility of medicines. Improvements in affordability will be driven by rising disposable incomes and increasing insurance coverage. Growth in accessibility will come from increases in government spending and medical infrastructure, and new business models for rural areas. The acceptability of medicines is also expected to rise, as a result of the growth in chronic conditions - and the resulting increase in the self-administration of drugs. Diagnostics was seen by the workshop delegates as a key focus area where innovation can drive sustained growth. One of the problems is a shortage of diagnostics laboratories. Physicians often prescribe an empirical therapy because the cost of diagnosis is much higher than the cost of the therapy. For example, antibiotics are commonly prescribed for respiratory infections - where the causative pathogen may actually be a virus. But the idea that healthcare innovation in emerging markets has to focus only on cost reduction was dismissed by the pharma experts. The example of smartphones was highlighted - how their adoption has penetrated all levels of society. This suggests that 'value', at the right price point, is more relevant in driving adoption of new technologies. ]]> <![CDATA[Microalgae may be new natural source for antibiotics]]> https://biospectrumindia.com/news/95/6512/microalgae-may-be-new-natural-source-for-antibiotics.html https://biospectrumindia.com/news/95/6512/microalgae-may-be-new-natural-source-for-antibiotics.html Mon, 29 Jun 2015 15:26:59 +0530 Bacteria are resourceful, and their growing resistance to antibiotics has drawn attention and caused concern worldwide. There is an urgent need to find new sources of antibiotics. Among other options, scientists are turning to natural compounds from relatively unexplored microorganisms. An article published in Phycologia looked at one such group of microorganisms: microalgae. Researchers have investigated only a few species so far, but work with freshwater microalgae collected from remote, scientifically unexplored regions in northern Canada has produced several promising candidates for antibiotics. Microalgae are found everywhere: in lakes, rivers, garden ponds, even swimming pools. Yet little research has focused on them as potential antibiotics. Most antibiotics used today were created from bacteria, and the increasing resistance of the bacteria has prompted research into synthetic variations. The article argues that microalgae may be another potential source of resistance-proof antibiotics. Researchers have found that microalgae can survive in and adapt to a range of harsh environmental conditions. Changes in temperature, light, pH, salinity, and the availability of nutrients have been extensively studied for their effects on microalgal growth. The adaptability of the microalgae suggests that they can develop resistance against a variety of stresses. Microalgae also produce compounds that can stand up to the activity of some of the bacteria that sicken people. When their environment changes, these microorganisms produce even more antibacterial compounds. The ability of microalgae to survive and adapt to a range of environments may be highly valuable to drug manufacturers. This makes them a potential resource in manufacturing antibiotic drugs. Advances in technologies that can detect, purify, and identify the antibacterial compounds produced by microalgae only increase the possibilities for new antibiotics. Still, there are no commercially available antibiotics from microalgae. More research is needed into these microorganisms to take advantage of this 'untapped' source. ]]> <![CDATA[Health ministry focuses its attention on North-East]]> https://biospectrumindia.com/news/95/6814/health-ministry-focuses-its-attention-on-north-east.html https://biospectrumindia.com/news/95/6814/health-ministry-focuses-its-attention-on-north-east.html Mon, 29 Jun 2015 11:47:12 +0530 Mr Jagat Prakash Nadda reviewed the health sector of the North Eastern states in a meeting held at Assam Administrative Staff College in Guwahati recently. Health ministers and secretaries of the eight north eastern states-Arunachal Pradesh, Assam, Nagaland, Manipur, Mizoram, Meghalaya, Tripura, and Sikkim participated in the review meeting. The Union health minister urged the states for optimum use of resources that are being provided by the center. The state health ministers presented the issues that need to be addressed on a priority basis for bringing about desired changes in the health scenario of the states. The Union Health Minister took note of the issues related to maternal health, child health, family planning, vector borne diseases and non-communicable diseases. Mr Nadda urged the states to accord priority to advance preparedness for dealing with dengue, malaria and other vector borne diseases in order to prevent the disease and effectively manage it with the onset of monsoon. Mr Nadda informed of two important decisions that have been taken to bring about desired changes in health indicators- IMR, MMR and TFR. First, Regional Resource Centre Northeast will be developed for building capacities of the states for programme implementation, importance on Public Health Program, Information, Education and Communication (IEC) to be strengthened with community participation and quality assurance to be ensured. Second, a Joint Secretary from Ministry of Health and Family Welfare will visit North Eastern states once in a month to oversee implementation of programmes and address the bottlenecks. The Union Health Minister was sympathetic of the difficulties that the north eastern states are facing in providing quality health care services-from difficult terrain, hilly areas, poor communication facilities, detrimental weather etc. He drew instances of his state which is also a hilly state. He suggested that innovative measures need to be evolved to overcome natural gap and build a robust system of our own. Shri Nadda suggested for strengthening District Hospitals and Sub-Divisional Civil Hospitals with rational deployment of doctors and paramedical staff. He stressed on the need to develop public health planning with quality training of paramedics. The Union Minister emphatically said that there is no shortage of fund for ensuring health care services and urged that states should submit utilisation in time for streamlining the flow of funds from the state. He also urged that procurement should be transparent and need based for ensuring quality and regular supply. The Union Health Minister appreciated each state for the achievements shown so far and urged everyone to work for betterment of the health care services. He particularly appreciated the efforts of Assam in introducing BSC (Community Health) for providing health care services in rural areas. The Union Health Minister visited the North Eastern Indira Gandhi Regional Institute of Health and Medical Sciences (NEIGRIHMS), Shillong and addressed the meeting of the Governing Council yesterday. ]]> <![CDATA[Second green revolution a must: PM Modi ]]> https://biospectrumindia.com/news/95/6730/second-green-revolution-a-must-pm-modi-.html https://biospectrumindia.com/news/95/6730/second-green-revolution-a-must-pm-modi-.html Mon, 29 Jun 2015 11:39:37 +0530 The Prime Minister Mr Narendra Modi while speaking after laying the Foundation Stone of the Indian Agricultural Research Institute on June 28, 2015 at Barhi in Jharkhand, called upon farmers to raise the level of pulses production in the country, to help make India self-sufficient in pulses as these are an important part of the diet of the common man. Mr Modi also said that the need of the hour was a second green revolution, without any delay, in eastern India. He said that the union government was therefore committed to the development of this region. The Prime Minister further said that animal husbandry and fisheries were equally important for the agriculture sector. He further added that the Government has decided to pay special attention to the dairy sector in Jharkhand. The Union Agriculture Minister, Mr Radha Mohan Singh while welcoming the Prime Minister Mr Narendra Modi at the foundation laying ceremony of the IARI in Jharkhand, said that it was the need of hour to set up a second IARI in Jharkhand on the lines of IARI, Pusa, New Delhi. The Union Minister said that the Institute at Jharkhand will help in meeting the challenges in the field of agriculture in the State in a scientific manner. The Institute would help in developing this Economic Zone in a scientific manner. The Minister added that the announcement of setting up of a second IARI in the country was made in the General Budget of the year 2014-2015 and he thanked the Prime Minister that the setting up of such an Institute was made possible under his leadership and guidance. Soon after this announcement in the Budge-2014-2015, the Ministry of Agriculture and the State Government of Jharkhand went into action to identify the land for the second IARI and this activity was completed within a year's time. And that is how, the Minister added that this laying of Foundation Stone for IARI was possible. ]]> <![CDATA[Siemens partners with BioNTech ]]> https://biospectrumindia.com/news/95/6282/siemens-partners-with-biontech-.html https://biospectrumindia.com/news/95/6282/siemens-partners-with-biontech-.html Mon, 29 Jun 2015 11:25:17 +0530 Siemens and BioNTech AG, have entered into a strategic collaboration. BioNTech AG's subsidiaries, BioNTech RNA Pharmaceuticals GmbH and EUFETS GmbH, will work together with Siemens on the construction of a fully automated and digitalized production site to provide capacity for BioNTech's truly personalized cancer vaccines to serve worldwide markets. The cooperation will enable BioNTech to establish and integrate all necessary process and production steps for manufacturing its IVAC individualized vaccines at a larger scale. This strategic collaboration brings together each partner's specific competences in order to optimize automation and digitalization technology for a paperless, commercial-scale GMP (Good Manufacturing Practice) manufacturing of truly personalized medicines. Mr Ugur Sahin, CEO of BioNTech, said, "We are pleased to partner with Siemens on automating a specialized, proprietary manufacturing process for truly personalized medicine. Siemens' world-class expertise in engineering and optimizing automatic manufacturing processes will be of great value in making personalized cancer treatment for patients available to all." Mr Eckard Eberle, CEO of the Siemens Business Unit Process Automation, said,"The development and manufacturing of personalized medicine is connected with massive amounts of data. Solutions such as our manufacturing operations management (MOM) software are able to handle the complexity of this innovative new process technology. Together with BioNTech's competence in individualized medicine, we will pave the way for a digital plant with an efficient and completely paperless production." The IVAC MUTANOME Immunotherapy approach is based on targeting the unique mutation signature of an individual patient's tumor. It is engineered on demand and administered as an individual treatment. IVAC MUTANOME is currently in a Phase I/IIa clinical trial for the treatment of malignant melanoma. ]]> <![CDATA[Global gene therapy deals sky-rocketed to nearly $5 bn in 2014]]> https://biospectrumindia.com/features/95/6058/global-gene-therapy-deals-sky-rocketed-to-nearly-5-bn-in-2014.html https://biospectrumindia.com/features/95/6058/global-gene-therapy-deals-sky-rocketed-to-nearly-5-bn-in-2014.html Sat, 27 Jun 2015 08:10:00 +0530 The total number of deals in the global gene therapy market more than doubled from 16 in 2013 to 36 in 2014, with their combined value rising spectacularly from $122.8 million to $4.9 billion over the same period, representing a forty-fold increase, says research and consulting firm GlobalData. The company's latest report states that merger and acquisition (M&A) activity is typically low in the gene therapy field, as the technology remains highly experimental and the majority of products are in early-stage clinical development. Despite this, the impressive growth in the overall deals value for 2014 was boosted primarily by Abbott Laboratories' $2.9 billion acquisition of CFR Pharmaceuticals (CFR), a Chilean biotechnology company developing gene therapeutics for alcoholism and chronic pain. CFR has a product in its clinic that targets aldehyde dehydrogenase, an enzyme produced in the liver and kidneys aiding alcohol rejection. Mr Adam Dion, GlobalData's senior industry analyst, says: "Licensing and partnerships, together with capital raisings, have represented the largest number of gene therapy deals struck since 2009. Licensing deals have so far outpaced historical levels, with over $1.8 billion signed in 2015. "These deals include Bristol-Myers Squibb's $1 billion licensing agreement with UniQure to develop S100AI, UniQure's Phase I candidate for congestive heart failure, representing the deal with the greatest financial impact so far this year. Voyager Therapeutics also signed an $845 million agreement with Genzyme to develop three Phase I programs concerning the central nervous system." The analyst adds that as well as licensing agreements, equity offerings are a common strategy for companies to raise funds, enabling them to advance clinical pipelines and bring gene therapies to market. Mr Dion continues: "Nearly $1.5 billion was raised in the gene therapy arena from 2014 to 2015, of which almost $750 million resulted from Avalanche, bluebird bio and Spark Therapeutics going public. Furthermore, Paris-based Cellectis announced in March 2015 that it had raised $230 million in an initial public offering, which the company will use to advance its blood cancer pipeline from preclinical testing to Phase I clinical trials. "This rise in financial investment may be indicative of renewed investor confidence, and could lead to higher-than-expected deal activity for gene therapies in the future," the analyst concludes. ]]> <![CDATA[Viscosupplementation market value to exceed $2.6 bn by 2021]]> https://biospectrumindia.com/features/95/6020/viscosupplementation-market-value-to-exceed-2-6-bn-by-2021.html https://biospectrumindia.com/features/95/6020/viscosupplementation-market-value-to-exceed-2-6-bn-by-2021.html Fri, 26 Jun 2015 12:37:32 +0530 The viscosupplementation market value will increase from approximately $1.76 billion in 2014 to a little under $2.64 billion by 2021, across the ten major markets (10MM) of the US, France, Germany, Italy, Spain, the UK, Japan, Brazil, China, and India, with the US continuing to hold the largest share, says research and consulting firm GlobalData. The company's latest report states that growth in the viscosupplementation space will be driven by strong healthcare infrastructure, well-established reimbursement, and aggressive marketing efforts from the supply side, as well as the trend towards early intervention and the soaring demand for non-surgical osteoarthritis treatment. According to Ms Linda Tian, GlobalData's managing analyst covering medical devices, in addition to the US, the Asia-Pacific (APAC) region represents a promising avenue for volume growth in the viscosupplementation sector. Ms Tian explains: "In Japan, the second largest viscosupplementation market, it is common for patients to have hyaluronic acid injections on a regular basis, with the therapy prescribed at a fraction of the cost to that in the US and Europe. "China has also contributed to the significant increase in APAC viscosupplementation procedure volume over the past decade, and still has a substantial underserved population. The large patient pool, which is finally gaining access to advanced medical treatment as healthcare reform reaches China's rural regions, will be a key growth driver during the forecast period." While the 10MM are expected to increase in terms of both procedure numbers and revenues, the market in the five European countries (5EU: France, Germany, Italy, Spain, and the UK) is fairly mature and will experience slow expansion, according to GlobalData. The analyst continues: "Drug spending in Europe is currently limited by a weak economic recovery, low population growth, and continued efforts to reduce the public debt. "Surgeons' dampened enthusiasm about viscosupplementation, along with reimbursement challenges and cost-containment pressures, will continue to negatively impact the 5EU viscosupplementation market expansion, which will be compounded by suppliers focusing on the fast-growing US and APAC regions." ]]> <![CDATA[India inks health pact with the US]]> https://biospectrumindia.com/news/95/6025/india-inks-health-pact-with-the-us.html https://biospectrumindia.com/news/95/6025/india-inks-health-pact-with-the-us.html Fri, 26 Jun 2015 12:30:34 +0530 India and the United States of America (USA) have signed Memorandums of Understanding (MoUs) on Cooperation on Cancer Research, Prevention, Control, Management and Collaboration in Environmental and Occupational Health, and Injury Prevention and Control, and a Letter of Intent (LoI) on Antimicrobial Resistance Research. The MoU on Cancer Research and LoI on Antimicrobial Resistance Research were signed by Shri B P Sharma, Secretary (Department of Health and Family Welfare and Department of Health Research), Ministry of Health and Family Welfare and Prof. K Vijay Raghavan, Secretary (Department of Biotechnology), Ministry of Science and Technology and Mr Richard Verma, Ambassador of the USA to India. While, the MoU on Collaboration in Environmental and Occupational Health and Injury Prevention and Control was signed by Mr BP Sharma and Mr Richard Verma. The MoU for cooperation on cancer research prevention, control and management was signed between the National Cancer Research Institute of the All India Institute of Medical Sciences, the Indian Council of Medical Research (ICMR), Department of Health Research, Ministry of Health and Family Welfare, the Department of Biotechnology, Ministry of Science and Technology and National Cancer Institute of the National Institute of Health and Department of Health and Human Services (DHHS), USA. The MoU intends to strengthen the collaboration on the following, Promotion and development of cooperation in the fields of clinical cancer research and patient care delivery; Infrastructure development, training, and capacity building; Collaboration in cancer research including basic, translational and survivorship research, epidemiology, prevention, diagnosis, screening, treatment and control; Direction of increased collaboration between appropriate Centers of Excellence and Institutions in both countries, as recommended by the Participants; and Assessment and application of new and cost effective cancer diagnostic technologies for public health benefits, and the translation of technologies for global health. The second MoU was signed between the Centre for Disease Control (CDC) and Prevention, Department of Health and Human Services of the USA and the Indian Council of Medical Research (ICMR), Department of Health Research, Ministry of Health and Family Welfare on Collaboration in Environmental and Occupational Health and Injury Prevention and Control. The MoU aims to further the cooperation in the fields of environmental and occupational health and injury prevention and control research, education and training, infrastructure development, and capacity-building for their reciprocal and mutual benefit. A Letter of Intent (LoI) on Antimicrobial Resistance Research was signed between the Indian Council of Medical Research (ICMR), Department of Health Research, Ministry of Health and Family Welfare, the Department of Biotechnology, Ministry of Science and Technology and the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Department of Health and Human Services of USA. This aims to strengthen cooperation between the two countries in antimicrobial resistance research. The signatories welcomed signing of the agreements and hoped that these MoUs/LoI will usher in greater cooperation in the health sector which will benefit people of both the countries, in addition to further deepening and strengthening of cooperation and collaboration between the countries. ]]> <![CDATA[Indigenous test to monitor cerebral palsy recognized globally]]> https://biospectrumindia.com/news/95/5868/indigenous-test-to-monitor-cerebral-palsy-recognized-globally.html https://biospectrumindia.com/news/95/5868/indigenous-test-to-monitor-cerebral-palsy-recognized-globally.html Thu, 25 Jun 2015 16:16:00 +0530 Doctors at Nutech Mediworld, the world's only human embryonic stem cell therapy center based in India, have demonstrated the effectiveness of a tool to track improvement of Cerebral Palsy (CP) patients after undergoing treatment. The tool, the first of its kind, tracks over 32 parameters to provide accurate assessment of the progress of the disease as compared to the existing method of screening. The result of this new study tool, called Nutech Functional Score (NFS), developed by Dr Geeta Shroff, has been published in the International Archives of Medicine (June, 2015), an open access international medical science and clinical practice journal. NFS can assess all known symptoms of CP that remain far from assessment using the presently used testing system called the Gross Motor Function Classification System (GMFCS). These include feeding, indication, epilepsy, toilet training, drooling, mathematical skills, hearing, vision, commands, smiling, constipation, recognition/awareness, eye contact, aggression, speech, breathing difficulty, defence mechanism and swallowing. As opposed to GMFCS, NFS scoring system is not only more sensitive towards infants but can also be used to assess patients aged above 18 years. As per Dr Geeta Shroff, founder and medical director, Nutech Mediworld, "Our test will help in better evaluation and monitoring of CP patients following treatment. It will also help in better disease management and course correction as it covers all the known symptoms that are important to assess patient with CP." GMFCS scoring system, measured in grades, poses certain limitations as it is based only on self initiated movement, especially ability to walk and stand. The distinction between first two levels of GMFCS is unclear, mainly for children below the age of 2 years. "The other advantage of using NFS is that scoring is numeric which means grades can be added or subtracted, thus revealing even the slightest improvement in the patient. While NFS tells the condition of a case from bad to good, GMFCS (a single score assigned on the basis of age and motor function) classifies CP into five levels from good to bad," added Dr Shroff. The study was conducted on CP patients who undertook human embryonic stem cell treatment Dr JK Bharthakur, co-researcher said, "The facility has been treating patients with CP since 2000. While grading the CP patients with existing scoring system, the doctors felt it difficult to grade several parameters. This led to the development of NFS." CP is a non-progressive disorder that occurs as a result of the damage to the brain of a foetus and newborns. Its signs and symptoms, such as spastic muscles, poor balance and gross motor delays remain lifelong and patient is subject to life with limitations. It is estimated to affect 3 per 1,000 live births in India. The treatment of CP with human embryonic stem cell therapy has emerged as one of the most effective and safe solutions in recent years. This treatment has aided in reversing and helping to cure the signs and symptoms of CP. At Nutech Mediworld, patients from as far as Iceland and Australia come to undertake treatment. ]]> <![CDATA[Cardiovascular disease among top five killers: NIC report]]> https://biospectrumindia.com/news/95/5773/cardiovascular-disease-among-top-five-killers-nic-report.html https://biospectrumindia.com/news/95/5773/cardiovascular-disease-among-top-five-killers-nic-report.html Thu, 25 Jun 2015 15:37:00 +0530 While Cardiovascular Disease (CVD) is today the leading cause of morbidity and mortality in India. The number of patients who are treated with stents remains very low. Only 3 out of 1,000 coronary heart disease patients get treated with Percutaneous Coronary Intervention in India, the recent NIC (National Interventional Council) report suggests. As per reports, India is expected to soon bear the largest burden of heart disease globally. Cardiovascular diseases (CVDs) is the first among the top five causes of death in the Indian population, with forecasts estimating that over 61.5 million people in India would be suffering from Coronary Heart Disease by 2015. The data divulged that even though there has been an increase in the number of cases, the rate of growth of coronary interventions has gone down over the past two years from 22 percent in 2013 to 14 percent in 2014. Over the same period, the percentage growth of stents used has also slowed down to 18 percent in 2014 from 22 percent in 2013. NIC conducted a survey collecting data from 396 cath labs in the country. The data reveals: Only two percent of the labs are conducting more than 2,000 angioplasties per year; 70 percent labs are conducting less than 500 cases per year and CVD is highly under-diagnosed and even less treated through PCI - only 0.28 percent. Dr Chandra said, "Due attention should be given to building infrastructure and providing support to the small centers, that need support in training and infra to grow further. It's important to note that the treatment adoption of stenting has not increased significantly in the low-price, subsidized segment. The government funded procedures came down from 45 percent contribution of the overall procedures in 2013 to 37 percent contribution of the overall procedures in 2014. This is mainly due to lack of attention to the other factors responsible for treatment delivery such as availability of highly skilled implanters and support staff, availability of advanced facilities like CathLabs for stenting procedure and lack of proper patient referral mechanism." The data also shows:· 28 percent of the patients are women - increase from 25 percent in 2013· 11 percent of the patients are below 40 years of age· 22 percent of the patients had blockages in more than 1 artery· 43 percent of the procedures were self-funded - Out of pocket expenditure has increased from 39 percent in 2013· Decrease in Govt Funding - from 45 percent in 2013 to 37 percent in 2014· Rate of growth has fallen to 14 percent compared to 2013 when the growth rate was 22 percent. ]]> <![CDATA[Pharma outsourcing accounts for 75% of India's healthcare BPO market: ASSOCHAM-EY study]]> https://biospectrumindia.com/reports-white-papers/95/5591/pharma-outsourcing-accounts-for-75-of-indias-healthcare-bpo-market-assocham-ey-study.html https://biospectrumindia.com/reports-white-papers/95/5591/pharma-outsourcing-accounts-for-75-of-indias-healthcare-bpo-market-assocham-ey-study.html Thu, 25 Jun 2015 13:59:22 +0530 At $2.5-3.1 billion, pharmaceutical outsourcing market (excluding contract manufacturing services) accounts for about 75 percent of the India's medical process outsourcing (MPO) segment which is currently estimated at $3.3-4.2 bn, according to ASSOCHAM-EY joint study. "While the payer outsourcing market constitutes $700-900 million of India's MPO market, the provider market accounts for the remaining share of about $100-200 mn," noted the study titled 'Medical Process Outsourcing in India,' jointly conducted by The Associated Chambers of Commerce and Industry of India (ASSOCHAM) and global professional services organization EY. The recent US regulation on Patient Protection and Affordable Care Act (PPACA) together with the proposed introduction of ICD-10 standards have given impetus to the Indian MPO market. Besides, domestic players are also gradually moving up the value chain in terms of service offerings while maintaining their cost competitiveness. "All of these combined will give a boost to the MPO market, with payer BPO market likely to grow at about 10 percent year-on-year (Y-o-Y) in the next three to four years globally, provider outsourcing at more than 30 percent during 2011-2016, and the Contract Research Organizations (CROs) market at 18-20 percent in the coming years," highlighted the study. "We believe that there has been an ample push from healthcare payers, providers and pharmaceutical companies to move non-core processes to third-party service providers, and India has been one of the leading destinations for outsourcing in this space," said Mr D S Rawat, secretary general of ASSOCHAM. "India has emerged as the second largest destination after the US in the healthcare outsourcing space. The growing ability of Indian players to analyze big data, discover hidden patterns and unknown correlations are driving new service offerings in this market," said Mr Milan Sheth, partner and technology industry leader, EY India. Overall, Indian BPO industry stands to gain from the growing demand in healthcare outsourcing. An evolved medical education system and its established prowess as a hub for outsourcing give India an inherent advantage. Factors like a mature pharmaceutical and medical education system, large English-speaking population, low cost base, large talent pool and diverse set of business process outsourcing (BPO) providers including local and multinational BPO companies are driving outsourcing in healthcare in India, noted the study. Besides, rising demand for high-end healthcare facilities and multi-specialty hospitals, established medical and central lab infrastructure and training centers is contributing to the growth of healthcare and life sciences industry thereby fuelling the domestic demand for medical process outsourcing, it added. In order to fuel growth in MPO sector, the ASSOCHAM-EY study has suggested the government to focus on implementing data privacy laws, introducing proper regulations around intellectual property and patent laws, and give a boost to education to help bridge the skill gap. Although, Indian regulatory environment has been constantly evolving, the challenges around privacy laws, intellectual property laws and changing clinical trial laws continue to exist. ]]> <![CDATA[Mr Kamil Hamied quits Cipla: Reports]]> https://biospectrumindia.com/news/95/5460/mr-kamil-hamied-quits-cipla-reports.html https://biospectrumindia.com/news/95/5460/mr-kamil-hamied-quits-cipla-reports.html Thu, 25 Jun 2015 13:12:31 +0530 Mr Kamil Hamied, nephew of Cipla's chairman Mr Yusuf K Hamied has quit the firm and his sister Ms Samina Vaziralli has assumed an expanded role in the company, says reports. Mr Kamil was supposed to take a leadership role in the drug major Cipla. "As part of his leadership development, Mr Kamil Hamied, who had stepped out of the India parent and was working in our EU subsidiary in London, will take some time to broaden his leadership and business experience outside of Cipla to achieve his personal growth objectives," said a Cipla spokesperson, in a statement. "Ms Samina Vaziralli, who represents the next generation of the promoter family, continues to be a part of the core management team at Cipla and now takes on an expanded role leading global strategic alliances and building our consumer health business in India," the spokesperson further added. ]]> <![CDATA[FDA approval for Zydus's new drug]]> https://biospectrumindia.com/news/95/5403/fda-approval-for-zyduss-new-drug.html https://biospectrumindia.com/news/95/5403/fda-approval-for-zyduss-new-drug.html Thu, 25 Jun 2015 12:55:26 +0530 Zydus Cadila has received the final approval from the United States Food and Drug Administration (US FDA) to market Pyridostigmine Bromide Tablets USP, 60 mg. The estimated sales in 2015 for Pyridostigmine Bromide Tablets USP, used in the treatment of various neurological disorders, is $27.9 million, as per IMS. The group now has 100 approvals and has so far filed over 260 ANDAs since the commencement of the filing process in FY 2003-04. ]]> <![CDATA[Global spend on medicines to reach $1.3 trillion by 2018]]> https://biospectrumindia.com/reports-white-papers/95/5346/global-spend-on-medicines-to-reach-1-3-trillion-by-2018.html https://biospectrumindia.com/reports-white-papers/95/5346/global-spend-on-medicines-to-reach-1-3-trillion-by-2018.html Thu, 25 Jun 2015 12:46:37 +0530 This level of growth-a compound annual growth rate of 4-7 percent on a constant currency basis-will be slightly higher than the 5.2 percent recorded over the past five years, as the introduction of new specialty medicines and increased accessibility for patients coincides with lower impacts from patent expiries in developed markets. Global economic recovery continued in 2013 and is expected to strengthen during the first half of the forecast period The report also points that significant downside risks remain due to uneven economic recovery in Europe, political tension in Russia, and recent events in Africa and the Middle East The global population aged 65 and over will grow faster than any other age segment, and will account for almost 30 percent of overall population growth in the next five years Strong economic recovery in the US and recent healthcare reform have already had a positive impact on the use of medicines and will grow the market through the first half of the forecast period Drug spending in Europe will remain limited by a weak economic recovery, low population growth, and continued efforts to reduce public debt, including healthcare and drug spend Southeast and East Asia will grow at twice the global average, driven by population growth, rising incomes and improved access to healthcare North America is said to continue to contribute the largest proportion to growth, but Asia seems to be gaining. ]]> <![CDATA[BMS will win big with melanoma combination immunotherapy: GlobalData ]]> https://biospectrumindia.com/features/95/7881/bms-will-win-big-with-melanoma-combination-immunotherapy-globaldata-.html https://biospectrumindia.com/features/95/7881/bms-will-win-big-with-melanoma-combination-immunotherapy-globaldata-.html Thu, 25 Jun 2015 10:06:05 +0530 Data presented at the recent American Society of Clinical Oncology (ASCO) Annual Meeting 2015 by Bristol-Myers Squibb (BMS) suggests that its Opdivo/Yervoy combination of immunotherapies to treat metastatic melanoma will shape the therapeutic landscape once it is approved, says an analyst with research and consulting firm GlobalData. According to Dr Fenix Leung, GlobalData's analyst covering oncology and hematology, data from BMS' Phase III trial, CheckMate-067, which compared the combination of the Opdivo (nivolumab) and Yervoy (ipilimumab) regimen and Opdivo monotherapy with Yervoy monotherapy, stood out from the crowd because of the combination's exceptional clinical efficacy. As a consequence, with both Opdivo and Yervoy in its arsenal, GlobalData expects BMS to bag peak-year sales of $3.28 billion for both the monotherapies and the combination therapy across the eight major markets of the US, France, Germany, Spain, Italy, UK, Japan, and Australia in 2023. Dr Leung commented: "Overall, in terms of clinical efficacy, BMS' immunotherapy combination is a clear winner in the melanoma treatment market. Should Opdivo's competitors continue to focus on monotherapies, GlobalData expects them to have a hard time catching up to BMS' combination therapy in this regard. "Currently, companies with immuno-oncology drugs, both marketed and pipeline, are teaming up in the hope of repeating BMS' success. Merck is collaborating with Amgen, Dynavax, and Syndax to find a potential Keytruda (pembrolizumab)-containing combination for melanoma, while AstraZeneca has joined hands with Immunocore, Novartis, and Incyte." However, the analyst warns that unless these companies are able to develop an immunotherapy combination that is more efficacious and/or less toxic than BMS' combination therapy, the New Jersey giant is likely to dominate the melanoma treatment market for a long time. Dr Leung continued: "Key opinion leaders interviewed by GlobalData are enthusiastic about the efficacy of the combination, and foresee it as the future standard of care. However, issues such as safety and high cost may restrict its sales. "The high cost of immuno-oncology therapies, especially when drugs are used in combination, is likely to result in a pushback from payers regarding the Opdivo combination regimen, opening the door for competitors, such as Merck's Keytruda. In order to ease payers' resistance, BMS may decide to offer a discount if Opdivo and Yervoy are used in combination," the analyst concluded. ]]> <![CDATA[Syngene gets FIBP nod ]]> https://biospectrumindia.com/news/95/4858/syngene-gets-fibp-nod-.html https://biospectrumindia.com/news/95/4858/syngene-gets-fibp-nod-.html Wed, 24 Jun 2015 16:08:50 +0530 Syngene has announced that it has received the Foreign Investment Promotion Board (FIPB) approval for raising foreign investment in the company to 44 percent. Earlier, the approved limit was 10 percent. The investment would be made when the company comes out with its initial public offer (IPO). The IPO is an offer for sale by Biocon which is selling its 10-15 percent stock from its majority stake in Syngene. Biocon now owns 83.6 percent stake in Syngene. "We have received the FIPB approval to increase the foreign investment limit in our company. This approval will enable us to look to broaden our global investor base," said Mr Peter Bains, CEO, Syngene International, in a statement. ]]> <![CDATA["Social media will play an effective role to disseminate telehealth"]]> https://biospectrumindia.com/interviews/95/6887/social-media-will-play-an-effective-role-to-disseminate-telehealth.html https://biospectrumindia.com/interviews/95/6887/social-media-will-play-an-effective-role-to-disseminate-telehealth.html Wed, 24 Jun 2015 13:42:46 +0530 Q: How can increased utilization of telehealth tools transform healthcare affordability in India? India is a huge country both in terms of size and population. Reasons that contribute to both increased costs and delivery are healthcare infrastructure costs, very busy urban life, increased commuting time in metropolitans for both Providers and clients, limited time of availability of providers to say a few. Availability of Physicians is seven per 10,000 of population (in 2013, source: who.org) compared to 30 plus per 10,000 in developed nations. Mental healthcare providers' situation is more than worst in terms of availability. There were 3 Psychiatrists per 10 lakh population and around five Psychologists per 1 crore population in 2011 (source: Mental Health Atlas 2011 - Department of Mental Health and Substance Abuse, World Health Organization). This makes the availability of professionals limited to the most demanding and high paying locations, leaving the rest of the locations un-served. With more than 50 percent of the population still dwelling in villages, there is an acute shortage of basic healthcare and Mental Healthcare services and facilities. Q: How can it play a role in healthcare delivery? Telehealth tools bridge the big gap of unavailability of these services at locations that are un-served or under-served, along with providing the urban population solution against time-crunch and commuting, and in mental healthcare vicinity beating the stigma and hesitation to take the first step. Telehealth tools also help in educating people and taking self motivated steps towards solutions as well as helping others. Through telehealth tools global experts and professionals sitting in other countries can make their services available in India. Due to lesser investments in infrastructure and real estate and running expenses, the cost of delivery of tele-healthcare is much lesser and flexi-work conditions for providers reduces the cost of services for the end client as well, along with many self help resources and tools being available free of cost on the telehealth portals these days. Q: Are health firms now getting social media savvy to improve their presence? What are the possible benefits and negative points if any? Social Media platforms have become information platforms as well, where people reach out for gathering basic knowledge, client experience, discussing their problems/needs and getting feedback about different products, companies and services. Thus, regularly reaching out to people on social media to inform, introduce and/or advertise the products or services, and to get and gather customer's feedback and experiences, has become one of the high priority task for all customer/client centric businesses. The immense benefits of social media activities include, regular engagement of organization with client and of client with other users of product/services that increases the chances of longer associations among the two if the delivery is good. Clients also feel that organization cares about them and values their opinion thus making association stronger. Social media helps big time in getting real time feedback of the product and/or services. Some negative points could be that Social Media messages that can please some population can annoy some others due to difference in opinion or cultural/religious context; false feedbacks by competitors can hurt or cyber bullying can affect the image of organization; unwanted criticism and feedback can deviate the focus or actions as well. Having said that, the positives of engaging with the customers/clients/potential customers on social media far outweigh the negatives and a relevant social media presence is therefore necessary. Q: How is your company responding to the new internet and social media requirements of healthcare providers and their clients? On Client End: Our company, ePsyClinic.com is providing world class holistic tele-mental health technology solution to clients, i.e. providing user friendly user interface, privacy and any place accessibility to providers through video, audio, text or telephonic consultation technology, easy booking and payments, to providing them right self help resources for free, free automated assessments, online planners assigned by providers that can be accessed anywhere anytime, and also easy regular communication with the experts. We also provide clients 24*7 guidance on how to reach out to the right provider and helping them in using the technology for their best benefits. On Provider End: Our company gives in-house training to providers for delivering best services through internet based communication mediums, which is not easy due to such mediums being impersonal. We also provide them technology training and assistance in maintaining regular communication with clients, in private and safe tech environment. On Social Media: We have one of the most alive social media presence within mental health care ecosystem. We actively engage with the larger audience through social media platforms like Facebook, Twitter. We share multiple free and helpful resources, useful tips on daily basis. We also receive feedback to improve upon our services. We are consistently looking out for new social media platforms and innovative content to engage and capture the imagination of the larger pool of audience. ]]> <![CDATA[Jubilant receives ANDA approval for Levofloxacin ]]> https://biospectrumindia.com/news/95/4485/jubilant-receives-anda-approval-for-levofloxacin-.html https://biospectrumindia.com/news/95/4485/jubilant-receives-anda-approval-for-levofloxacin-.html Wed, 24 Jun 2015 11:34:04 +0530 Jubilant Life Sciences has received Abbreviated New Drug Application (ANDA) final approval from the US Food and Drug Administration (US FDA) for Levofloxacin Tablets, 250mg and 500mg. Levofloxacin Tablets are the generic version of Levaquin Tablets (of Ortho-McNeil), which is used for the treatment of adults with infections such as pneumonia, bacterial sinusitis, chronic bronchitis, skin and skin structure infections, chronic bacterial prostatitis, urinary tract infections and inhalational anthrax. The total market size for Levofloxacin Tablets as per IMS is $28 million per annum. ]]> <![CDATA[Kolkata to host BIRAC 's workshop on bioentrepreneurship ]]> https://biospectrumindia.com/news/95/4340/kolkata-to-host-birac-s-workshop-on-bioentrepreneurship-.html https://biospectrumindia.com/news/95/4340/kolkata-to-host-birac-s-workshop-on-bioentrepreneurship-.html Wed, 24 Jun 2015 10:26:06 +0530 With an aim to sensitize the biotechnology industries, startups, entrepreneurs, academia and researchers about thegovernment funding support to the innovation ecosystem; pointers towards writing an effective grant proposal for industry innovation research; effective use and management of intellectual property tools. The event is expected to have the participation of biotech industry, budding entreprenuers, researchers, students. Scheduled to be held at Kolkata on June 27 and 28, the worshops will focus on BIRAC funding programs, effective grant writting skills, experience sharing by BIRAC supported innovator, tech-prenuership in life sciences sector on the first day. Besides that, the other areas such as securing and exploiting intellectual property rights in bioscience sector, patenting subject matters and biotech innovations are the focus ares on second day. The venue of the workshop is Centre for Research in Nanoscience and Nanotechnology (CRNN), University of Calcutta. ]]> <![CDATA[IDMA gears up to host Pharmac South 2015 in Chennai]]> https://biospectrumindia.com/news/95/8367/idma-gears-up-to-host-pharmac-south-2015-in-chennai.html https://biospectrumindia.com/news/95/8367/idma-gears-up-to-host-pharmac-south-2015-in-chennai.html Tue, 23 Jun 2015 14:32:34 +0530 Come July 3rd, Chennai will witness a large gathering of delegates representing various pharmaceutical enterprises at Pharmac South 2015 - the International Exhibition for Contract Manufacturers in Pharmaceutical, Nutraceutical, Ayurvedic products along with Pharma Machinery, Packaging, Equipment, Material, Bulk Drug, API, Clean Room and Water Technology. In association with Orbit Exhibitions Pvt. Ltd, Pharmac South is organized by the southern India chapter of Indian Drug Manufacturers' Association (IDMA-TNPSB). This two-day trade exhibition will be held on July 3rd and 4th at Chennai Trade Centre. The exhibition will be inaugurated by Secretary, Department of Pharmaceuticals, Ministry of Chemicals and Fertilisers, V K Subburaj. With the motto of bringing together manufacturers and buyers on a common platform, IDMA has invited more than 100 pharmaceutical and biopharmaceutical companies for this global event. The exhibition which is taking place for the second straight year will have manufacturers from the four south Indian States participating. Speaking at the curtain raiser of the event, President of Indian Drug Manufacturers' Association S V Veeramani said, "Pharmac South 2015 will provide pharmaceutical companies an opportunity to interact on a one-on-one basis. Small and medium-scale enterprises will be a benefited a lot from the exhibition, which is expected to be witness participations from around 2500 entrepreneurs." Chairman of the Indian Drug Manufacturers' Association M Rajarathinam said, "Tamil Nadu contributes only two per cent to the Indian pharma market. The exhibition will bring business to 400 manufacturers in Tamil Nadu. Export-oriented panel discussions will be conducted on topics like pharmaceutical export to ASEAN and African countries, new neutraceutical products for exports etc. New and innovative product launches will also take place at the event." ]]> <![CDATA[Intas launches first biosimilar to Lucentis]]> https://biospectrumindia.com/news/95/7632/intas-launches-first-biosimilar-to-lucentis.html https://biospectrumindia.com/news/95/7632/intas-launches-first-biosimilar-to-lucentis.html Tue, 23 Jun 2015 12:07:24 +0530 Ranibizumab is a therapeutic antibody fragment designed specifically for treating degenerative conditions of the eye. India-based Intas is the first company globally, to develop and launch a biosimilar version of ranibizumab. RAZUMAB is manufactured under strict guidelines for sterile use in the eye and is offered as single dose vial, thus reducing the risk of contamination during use. Ranibizumab blocks the production of vascular endothelial cell growth factor A (VEGF-A), a protein which when overexpressed leads to abnormal blood vessel growth in the retina, that can cause leaks and vision loss. Ranibizumab is indicated for the treatment of Neovascular (Wet) Age-related Macular Degeneration (AMD), a common degenerative condition of the eyes in the elderly. It is also indicated for Macular Edema following Retinal Vein Occlusion (RVO), Diabetic Macular Edema (DME), Diabetic Retinopathy in patients with Diabetic Macular Edema and vision loss resulting from choroidal neovascularization in pathologic myopia (mCNV). "Intas' ranibizumab, RAZUMAB is a 100 percent 'Made In India' molecule, a feat achieved by scientists at Intas and unparalleled till date. With the mission to provide global healthcare at affordable costs, RAZUMAB will be about 25 percent cheaper than the imported Lucentis in the hand of the patient. This would lead to an annual saving of about Rs 35,000 or more in the cost of treatment to the patient, depending on the number of injections used and the clinical condition of the patient. Our objective is to make the treatment available to a wider patient pool, that is as yet denied treatment due to high cost of imported Lucentis," said Mr Binish Chudgar, vice chairman, Intas Pharma. RAZUMAB is the tenth biosimilar launched by Intas in India, by far the largest number of indigenously developed biosimilars by any company. Since 2004, when Intas launched its first biosimilar, Intas has constantly worked to bring the latest in biological therapies to Indian patients at affordable prices. With its robust pipeline of future products under development, Intas aims to continue on this endeavor. Till date, Intas is also the only company from India to have launched a biosimilar in the highly regulated European market and is also the only company from India to have two of its biosimilars filed for registration in the US. Its first biosimilar for global markets, Accofil (filgratsim) was launched in Europe earlier this year. The company expects to launch its first biosimilar in the US within the next 9-12 months. Intas' manufacturing facilities are approved by global regulatory agencies such as EMA, ANVISA, WHO and others. RAZUMAB is also manufactured in the same facilities as its other biosimilars. ]]> <![CDATA[Pfizer to acquire GSK's meningitis vaccines]]> https://biospectrumindia.com/news/95/3864/pfizer-to-acquire-gsks-meningitis-vaccines.html https://biospectrumindia.com/news/95/3864/pfizer-to-acquire-gsks-meningitis-vaccines.html Tue, 23 Jun 2015 11:48:55 +0530 Pfizer has announced that it has entered into an agreement with GlaxoSmithKline (GSK) to acquire its quadrivalent meningitis ACWY vaccines, Nimenrix and Mencevax, for a total consideration of approximately $130 million (â‚¬115 million). Nimenrix (meningococcal serogroups A, C, W-135 and Y conjugate vaccine) is a single dose meningococcal ACWY-TT (tetanus toxoid) conjugated vaccine designed to protect against Neisseria meningitidis, an uncommon but highly contagious disease that can lead to disability and death. Launched three years ago, it is indicated for all age groups above one year of age. Nimenrix is currently registered and approved for sale in 61 countries across the European Economic Area (EEA 30), Canada, Australia and Emerging Markets, with registrations under review in another 18 countries across Africa, Asia, Eastern Europe and the Middle East. Mencevax (meningococcal polysaccharide serogroups A, C, Y and W-135 vaccine) is a single-dose meningococcal ACWY unconjugated polysaccharide vaccine used to control outbreaks of meningococcal infection and for travelers to countries where the disease is endemic or highly epidemic. Mencevax is indicated for use across all age groups from two years of age, and is currently registered and approved in 79 countries across Africa, Asia, Australia, Europe, Latin America, Middle East and New Zealand. "The addition of Nimenrix and Mencevax is an important milestone for Pfizer Vaccines. Adding these two innovative and complementary vaccines to our current portfolio will allow us to more completely respond to meningococcal disease outbreaks as well as proactively address a critical public health need the prevention of meningococcal disease across all ages," said Ms Susan Silbermann, president, Pfizer Vaccines. She added, "Acquiring these quadrivalent vaccines will broaden our ability to address the burden of meningococcal meningitis, an uncommon but serious and sometimes fatal disease. This helps us to further fulfill our vision to protect lives with innovative vaccines to fight serious diseases worldwide and gives us even greater capability to meet the needs of the global community we serve." Pfizer does not expect this transaction to have any significant impact on its 2015 financial performance. The transaction is subject to customary closing conditions as well as regulatory approvals in several markets, and is expected to occur in the second half of 2015. The company's legal advisors for the transaction were Ropes and Gray,and Clifford Chance. ]]> <![CDATA[GSK appoints new VP for South Asia]]> https://biospectrumindia.com/news/95/4107/gsk-appoints-new-vp-for-south-asia.html https://biospectrumindia.com/news/95/4107/gsk-appoints-new-vp-for-south-asia.html Mon, 22 Jun 2015 15:53:00 +0530 GlaxoSmithKline (GSK) Pharmaceuticals has announced the appointment of Mr Annaswamy Vaidheesh, as vice-president, South Asia and managing director effective 3 August, 2015. The company has further announced that he will succeed Dr Hasit Joshipura. Mr Vaidheesh's last assignment was as vice-president, Corporate Government Affairs, Asia-Pacific with Johnson & Johnson, based out of Singapore. Prior to this role, he was managing director, Johnson & Johnson Medical India and vice-president, Asia-Pacific - Diabetes franchise, based in Mumbai. GSK said in its press release that Mr Vaidheesh is a successful senior business leader from Johnson & Johnson with more than 28 years of diverse experience in the healthcare and FMCG industry. ]]> <![CDATA[BD Diagnostics & Lalpath Labs partner to launch best practices in phelebotomy]]> https://biospectrumindia.com/news/95/7653/bd-diagnostics-lalpath-labs-partner-to-launch-best-practices-in-phelebotomy.html https://biospectrumindia.com/news/95/7653/bd-diagnostics-lalpath-labs-partner-to-launch-best-practices-in-phelebotomy.html Mon, 22 Jun 2015 15:52:00 +0530 Aligned with its commitment to drive high-quality practices that improve patient safety in India, BD (Becton, Dickinson & Co.) and Dr Lal PathLabs recently inaugurated the Centre of Excellence in Phlebotomy (blood collection, sampling). This landmark initiative will provide certified phlebotomy courses to healthcare professionals, laboratory technicians, assistants and nurses, and support them in driving best practices in preanalytical processes for accurate and reliable diagnosis. BD also conducts workshops on phlebotomy based on good laboratory practices that are endorsed by the Association of Clinical Biochemists of India (ACBI), an organization that is at the forefront of constantly improving practices in laboratory medicine. BD will impart intensive training on fundamental principles of safe blood collection; specimen handling and sample preparation that will help develop the critical capacity of maintaining first-rate specimen quality and protect the safety of patients and medical staff. This new initiative will strengthen laboratory services by improving the quality of patient specimens and reducing incidence of preanalytical errors, thereby improving safety for both patients and healthcare workers. It is estimated that 70-85 percent of clinical decisions are based upon information derived from laboratory test results. "There are over 50,000 clinical laboratories in India and the number is increasing every year. Studies have indicated that nearly 68% of all errors in laboratory testing are associated with the pre-analytical phase - phlebotomy (blood collection) being a major component of this phase. There is immense potential to enhance the skills of laboratory technicians in line with the growing healthcare needs of the Indian population. With this Center of Excellence, BD will continue its commitment toward sharing knowledge and enhancing clinical practices in creating sustainable improvements in healthcare," said Mr Varun Khanna, managing director, BD - India. "Speaking on the occasion, Brig. Dr Arvind Lal, chairman and managing director, Dr Lal PathLabs said, "I am delighted to state that we introduced the BD manufactured Vacutainers for the first time in India in 1989. They have since then become an integral part of thousands of labs all over India and have added immensely to the high quality standards that prevail in our labs. This initiative to provide training for laboratory staff and clinicians will help in the long term for India's healthcare." ]]> <![CDATA[IPA launches website]]> https://biospectrumindia.com/news/95/3468/ipa-launches-website.html https://biospectrumindia.com/news/95/3468/ipa-launches-website.html Mon, 22 Jun 2015 13:32:40 +0530 According to Mr DG Shah, secretary general, Indian Pharmaceutical Alliance, "The website provides plenty of information and data on diverse subjects. Be it pricing, patents, drug regulatory regime or role and contribution of the national pharmaceutical industry to the economy. It shares IPA presentations at various fora and position papers on many subjects. Its rich content will help you to source various information related to the Indian pharmaceutical industry." Now users can also watch videos and read articles on key issues and refer to recent important news items relating to pharmaceutical industry. ]]> <![CDATA[New technology to diagnose hypertension in pregnancy]]> https://biospectrumindia.com/news/95/7557/new-technology-to-diagnose-hypertension-in-pregnancy.html https://biospectrumindia.com/news/95/7557/new-technology-to-diagnose-hypertension-in-pregnancy.html Mon, 22 Jun 2015 13:32:20 +0530 The company launched the first-of-its-kind biomarker, PLGF (Placental Growth Factor) to meet the alarming threat of the expecting mothers in recent times. PLGF (Placental Growth Factor) is used for accurate diagnosis and prognosis of 'pre-eclampsia', a major cause of maternal, fetal, neonatal morbidity and mortality. As per the industry findings, it is postulated that the incidence of pre-eclampsia is around 10-12 percent amongst Indian women irrespective of zones, against an incidence of 5-8 percent in developed countries. ]]> <![CDATA['India becomes the third largest source of FDI into UK']]> https://biospectrumindia.com/news/95/4112/india-becomes-the-third-largest-source-of-fdi-into-uk.html https://biospectrumindia.com/news/95/4112/india-becomes-the-third-largest-source-of-fdi-into-uk.html Mon, 22 Jun 2015 12:19:05 +0530 India's firms are increasing their investment in the United Kingdom, growing their businesses and gaining a competitive advantage, by forming 122 investment projects in the Great Britain's cutting-edge industries, says a report by UK Trade and Industry (UKTI) A report published to mark the UK's National Day at the World Expo in Milan by UKTI highlights how India's investment in the UK forms part of a record £1 trillion (or approx $1.5 trillion) of foreign direct investment (FDI) in the UK in 2014, making it the top FDI destination in Europe. British Commissioner to India, Sir James Bevan KCMG said, "India and the UK share a long-standing, highly collaborative relationship, fuelling the prosperity of both countries and we greatly value our association with India. The fact that in 2014-15 Indians were the third largest job creators in the UK is a tremendous testimony to the strength of our ties, while the UK is also the largest G20 investor in India, proving the two-way relationship. As Prime Minister Modi said, when the UK and India work together, we are an unbeatable combination. At a time when global FDI flows have fallen, investors from India understand that the UK is welcoming, diverse and open for business." The annual investment figures from UKTI for the 2014-15 financial year show the UK has attracted 12 percent more FDI projects compared to the previous year. According to the report, investment from India increased by 65 percent making it the UK's third largest source of FDI accounting for more than 9,000 new and safeguarded jobs. There was also evidence of a strengthening relationship with China, with 99 projects in 2014 resulting in more than 3,000 new jobs. Healthcare, agritech, food and drink are among the key sectors for investment from India. ]]> <![CDATA[Dr Reddy's launches HAiROOTZ in India]]> https://biospectrumindia.com/news/95/3252/dr-reddys-launches-hairootz-in-india.html https://biospectrumindia.com/news/95/3252/dr-reddys-launches-hairootz-in-india.html Mon, 22 Jun 2015 11:40:06 +0530 Dr Reddy's has announced the launch of HAiROOTZ, the first hair growth supplement to be marketed in India as over-the-counter (OTC) by the company. HAiROOTZ comes from the same branch of business that markets MINTOPTM. Studies reveal that more than 58 percent of men aged 30-50 years suffer from a common type of hair loss, due to modern lifestyles which has brought about various nutrition related deficiencies and diseases, hair loss being one of them. HAiROOTZ provides key nutrients needed for maintaining healthy hair. Stressful lifestyles often lead to hair greying and hair loss. HAiROOTZ's unique formula has grape seed extract containing potent antioxidants, which are 20 times greater than Vitamins E & C. Other key ingredients include Biotin which helps prevent excessive hair loss, minerals which have shown to reduce hair thinning, breakage and prevent dandruff and greying. It also includes key amino acids which would promote hair growth by improved blood circulation to hair roots. HAiROOTZ will be available across all leading departmental, pharmacy stores and online retailers. ]]> <![CDATA[Marine Biotechnology, an Indian Perspective]]> https://biospectrumindia.com/features/95/7146/marine-biotechnology-an-indian-perspective.html https://biospectrumindia.com/features/95/7146/marine-biotechnology-an-indian-perspective.html Mon, 22 Jun 2015 08:50:00 +0530 The global market for products from marine biotechnology is forecast to reach over $4 billion by 2015 and therefore marine bio-resources offer a lot of scope for the health and well being of aquaculture production in the country through marine bio-business. The Department of Biotechnology (DBT) has been supporting the program area of Aquaculture & Marine Biotechnology, covering both R&D and applied aspects through competitive grant scheme with the operational inputs from the Task Force Committee and with impetus during Brain Storming Sessions and workshops. For the past two decades, the department has been concentrating on developing technology for seed production and grow-out pond culture for economically important finfish and shellfish species, and also on seaweeds. It has been demonstrated that the technology developed by the department can produce fresh water prawn up to 1.5 to 2.0 ton/ha. Farmers who adopted this technology have been benefited. It is also noteworthy to mention that DBT has demonstrated high production rate in shrimp culture through semi intensive shrimp culture technology by producing 10 t/ha per annum in two crops. Research on induced breeding and maturation in commercially important fish and shrimp species has been carried out. Research has also been focused on various aspects such as Diagnostics, Vaccines, Recombinant products, Anti-microbial Peptides, Immunostimulants, High-energy and high-protein Aquaculture Feed, Fish Spawning Agents, Human Therapeutics (Omega-3 and 6), Water Quality Management, value addition and product & process development. Inventorisation and digitalization of marine and coastal bio-resources pertaining to marine mollusk are being carried out. Proposals through Public-Private Partnerships were pursued for leads in water re-circulatory system and management of metabolite load in the culture operations. During the last plan (2007-12), the Department has given major attention to aquatic health management. The emphasis was on development of technology for screening healthy population of shrimp/fish brooders based on molecular markers. In India, the loss of shrimp due to WSSV has been estimated to be about $150 million per year (CIBA, 2008). Application of various technologies especially biotechnological tools has made an impact in reducing disease risk. In addition, recent technologies are contributing to the future enhancement of aquaculture production. Vaccine is very important to prevent diseases in aquaculture systems. The DBT has funded many R&D projects to develop vaccines against different viral and bacterial pathogens of fish and shrimp. Recombinant and DNA vaccines have been developed for Aeromonas hydrophila, Vibrio anguillarum, Edwardsiella tarda, fish nodavirus, WSSV and MrNV. Recombinant vaccines using different genes such as OmpTS, Aha1 and OmpW have been developed and their efficacy against A. hydrophila was tested and found to be effective. Inactivated whole WSSV vaccine, recombinant subunit vaccine and DNA vaccine using different viral genes have been proved to be useful in small scale against WSSV in shrimp. Different types of Immunostimulants of bacterial or plant origin have been developed for cultivable organisms for their protection from viral and bacterial pathogens. Recently, a project on application of RNAi to control WSSV in shrimp has been funded by the DBT and good leads have been obtained. The Department has been laying major emphasis on the creation of centers of Excellence in the area of Marine Biotechnology addressing important areas like RNAi technology, nano-technology, extremophiles, cell-line development and their application, user friendly diagnostics and vaccines for new emerging diseases, immuostimulants, brood-stock development, production of disease free seeds, low cost feed development, and post harvest technology, natural product development, bio-fuels from marine algae, novel microbial enzymes for industrial applications, novel drugs from marine organisms for medicinal value etc. The University of Science and Technology at Cochin, Kerala, is working on projects in Marine Biotechnology covering aspects like genotypic characterization, gene-sequencing and isolation of novel enzymes and marine natural products and biomaterials, as well as establishing a database on marine biotechnology with the infrastructure and manpower support provided by the Department of Biotechnology. ]]> <![CDATA[Modi Raj: Bioscience awaits its 'acche din' ]]> https://biospectrumindia.com/features/95/5925/modi-raj-bioscience-awaits-its-acche-din-.html https://biospectrumindia.com/features/95/5925/modi-raj-bioscience-awaits-its-acche-din-.html Sun, 21 Jun 2015 08:38:00 +0530 Healthcare âˆ? National Health Policy-2015The Ministry has formulated the National Health Policy draft, 2015 and placed it in the public domain on 30th December, 2014 for wide stakeholder consultation. The feedback received from the stakeholders is presently being analyzed. The aim of the National Health Policy 2015 is to inform, clarify, strengthen and prioritize the role of the Government in shaping health systems in the country. This covers investment in the health sector, organization and financing of healthcare services, prevention of diseases and promotion of good health through cross sectorial action, access to technologies, developing human resources, encouraging medical pluralism, building the knowledge base required for better health, financial protection strategies and regulation and legislation for health.âˆ? Mission IndradhanushThe Ministry of Health & Family Welfare has launched "Mission Indradhanush", depicting seven colours of the rainbow, to fully immunise more than 89 lakh children who are either unvaccinated or partially vaccinated; those that have not been covered during the rounds of routine immunisation for various reasons. They will be fully immunised against seven life-threatening but vaccine preventable diseases which include diphtheria, whooping cough, tetanus, polio, tuberculosis, measles and hepatitis-B. In addition, vaccination against Japanese Encephalitis and Haemophilus influenza type B will be provided in selected districts/states of the country. Pregnant women will also be immunised against tetanus.The first round of the first phase started from 7 April 2015-World health Day- in 201 high focus districts in 28 states and carried for more than a week. This will be followed by three rounds of more than a week in the months of April, May June and July 2015, starting from 7th of each month. The 201 high focus districts account for nearly 50% of all unvaccinated or partially vaccinated children in the country. Of these, 82 districts are in just four states of UP, Bihar, Madhya Pradesh and Rajasthan and account for nearly 25% of all unvaccinated or partially vaccinated children of the country. 4.7 lakh children have so far been fully immunised. The children immunized under Mission Indradhanush are in addition to the children who are immunized under the Universal Immunisation Programme. Total of 297 districts will be targeted in the second phase to commence from September 2015. âˆ? India Newborn Action Plan (INAP)India loses about 7.5 lakh newborns (<28 days) every year primarily due to prematurity, sepsis and asphyxia. The India Newborn Action Plan (INAP) was launched in September 2014 to end all preventable newborn deaths and still births to a single-digit by 2030. The present neonatal mortality rate is 28 per thousand live births. âˆ?National Deworming DayAccording to WHO estimates, 24.1 crore children in the age group 1-14 year (68 percent of the total cohort) are at risk of parasitic intestinal worm infections that impair physical growth and cognitive development. The ministry observed the first National Deworming Day on 10 February 2015, followed with mop-up activities till 14 February 2015. It was implemented in 277 districts covering 11 States/UTs across 4.7 lakh schools and 3.67 anganwadi centers. âˆ?Maternal and Neonatal Tetanus Eliminated (MNTE) from the countryTotal of 32 States/UTs have been validated for Maternal and Neonatal Tetanus Elimination (MNTE) and the formal communication from WHO has been received. For the remaining four states of Nagaland, Meghalaya, Dadra & Nagar Haveli, and Jammu & Kashmir, field visits have been conducted by the joint team of WHO and UNICEF and the parameters for MNTE validation were found to be satisfactory. However, the formal communication from WHO is expected in two months.âˆ? Decision to introduce new vaccinesIn a bid to protect the children from more vaccine preventable diseases, new vaccines are proposed to be introduced as part of India's Universal Immunisation Programme (UIP). The Injectable Polio Vaccine will be introduced in October 2015. This will benefit 2.7 crore children every year. 20 high burden districts have been identified in Assam, Uttar Pradesh and West Bengal for adult JE vaccination in the age-group of 15-65 years. Rotavirus vaccine implemented to full scale would save approximately 1 lakh lives every year. Measles Rubella vaccine eliminates measles and its campaign will be carried out after appropriate planning and will cover 45 crore children. âˆ? Kala-Azar Elimination by 2015Action Plan for elimination of Kala Azar by 2015 launched in UP, Bihar, West Bengal and Jharkhand. This will benefit approximately 116.57 million population in the four states. The Action Plan includes active search, new drug regimen, coordinated Indoor Residual Spray (IRS) etc. First round of Indoor Residual Spray with DDT insecticide started in 33 districts of Bihar, 4 of Jharkhand and 11 in West Bengal. In addition, new non-invasive diagnostic kit has also been launched. âˆ? Drug resistant survey for 13 TB drugs launchedThe Health Ministry launched the biggest ever drug resistant survey in the world for 13 TB drugs in September 2014. The results are expected in a year's time. The nationwide drug resistance survey (DRS) will provide the Revised National TB Control Programme (RNTCP) with a better estimate on the burden of Multi-Drug Resistant Tuberculosis in the community. As part of the survey, the samples will be subjected to susceptibility testing for 13 anti-TB drugs (5 first line drugs and 8 second line drugs).In addition, under the Revised National TB Control Programme there has been rapid expansion of diagnostic facilities including highly sensitive molecular test at 119 facilities across various states for diagnosis of Multi-Drug Resistance TB and TB among HIV and pediatric patients. The baseline second line Drug Susceptibility Testing has been initiated in six states- Gujarat, Tamil Nadu, Kerala, Maharashtra, Karnataka and New Delhi.âˆ? National AIDS Control Program66 new targeted interventions have been established taking the total to 1,818 that provide HIV prevention services to female sex workers, injecting drug users, migrants, truckers, etc. Computerized Inventory Management System launched to strengthen the supply chain management system of Anti-Retroviral Drugs, enhance efficient use of the drugs and minimize wastages across the country.âˆ? Six new AIIMSWork has been expedited on the 6 new institutes equivalent to All India Institute of Medical Sciences (AIIMS) at Raipur, Bhopal, Patna, Bhubaneshwar, Rishikesh and Jodhpur. During the last one year, the hospital work has begun and all the 6 new AIIMS are providing high-end clinical care besides the MBBS teaching activities. In addition, 9 new AIIMS one each at Andhra Pradesh, Maharashtra, West Bengal, Uttar Pradesh, Jammu & Kashmir, Punjab, Tamil Nadu, Himachal Pradesh and Assam are proposed to be set up. âˆ? Womens health "Women's health, hygiene & nutrition" is the current focus under DBT's women's societal upliftment programme of DBT. The department has supported major programme on cervical cancer screening, genetic disorder & counseling, pregnancy-related complications, breast cancer screening & post-operative care. A project for awareness, counseling, screening & education to prevent genetic and congenital disorder has been implemented in West Bengal and a web based portal (www.genomegyan.com) on genetics has been developed to popularize it as a subject among medical students and physicians.Agriculture:In order to implement the long pending demand of technology driven agriculture, the concerned ministry has launched 'Mera Gaon, Mera Gaurav' scheme involving agricultural experts of agricultural universities and ICAR institutes for effective and deeper reach of scientific farming to the villages. A group of experts will be associated with one particular village to create awareness and adoption of new technologies including farm investment, loans, availability of inputs and marketing. All the scientists from ICAR and agricultural universities will participate in this initiative.Indian Institute of Agricultural Biotechnology is being established at Ranchi (Jharkhand). Also, National Research Centre on Integrated Farming System is to be established at Motihari, Bihar. A new Central Agricultural University has been planned at Barapani, Meghalaya and Post Graduate Institute of Horticulture is to be established in Amritsar. IARI has initiated its outreach programme to further expand the PG education by offering courses in Horticulture and Agricultural Engineering in collaboration with ICAR-Indian Institute of Horticultural Research, Bengaluru and ICAR-Central Institute of Agricultural Engineering, Bhopal respectively. Agriculture and Technology Foresight Centre (ATFC) is to be established to foresee the coming changes in agricultural sector and plan accordingly. Education: Hike in Research FellowshipsThe NDA Government has fulfilled the much awaited demand of research scholars by revising the fellowships for various categories such as Junior Research Fellows, Senior Research Fellows and Research Associates. Across the board hike in fellowship amount is at least 50 percent more than what was existing. The hike was made effective from October 01, 2014. Junior Research fellowship was hiked from Rs 16,000 to Rs 25,000. Senior Research Fellowship was hiked from Rs 18,000 to Rs 28,000. Research Associateship was hiked from Rs 22,000, Rs 23,000 and Rs 24000 to Rs.36,000, Rs38,000 and Rs 40,000 respectively.Knowledge Involvement in Research Advancement through Nurturing (KIRAN) programmme was launched in the year 2014 to bring gender parity in science through nurturing the research career of women scientists. The programme is aimed at providing opportunities to women scientists who had a break in their career primarily due to family responsibilities. The programme includes women-exclusive schemes and encourages them to foster their career by undertaking research not only in science & engineering but also for societal benefit besides making a career through entrepreneurship.Technical Research CentresFinance Minister during his budget speech 2014-15 had announced setting-up of five Technical Research Centres (TRCs) in the existing autonomous institutions of the Department of Science & Technology. A detailed road-map has been prepared by the Department for setting-up of these centres. Necessary approvals are being obtained for these centres. TRCs are expected to speed-up the technology transfer and commercialization process of the research work being carried out by these autonomous institutions. North East remains a priority areaThe twining programme of DBT has supported nearly 400 R&D projects, leading to more than 200 papers published in peer reviewed journals, and more than 450 young scientists of NER trained in advamced biotechnology. Every year approximately 70-80 projects under this flagship programme are being supported to NER.Also, the setting up of "DBT-NER Centre for Advanced Animal Diagnostics and Services on Animal Health and Diseases (ADSAHD) was announced on February 17, 2015. With a view to recognize promising mid-career scientists in NER, a programme of awarding Unit of Excellence grant to them has been initiated so as to enable them to pursue their innovative research in frontier areas of biotechnology. So far, 12 Units of Excellence have been established during the year. Enhanced Innovation Ecosystem:Under the DBT, for a well-defined Innovation Ecosystem for product development - a Public Sector undertaking, Biotechnology Industry Research Assistance Council (BIRAC) has been set-up, supporting nearly 300 companies and 100 young entrepreneurs for innovation, research and product development. Further, the Biotechnology Translational research and industry academia partnership has promoted through 3 Biotech clusters, 8 Biotech Parks and 13 Bioincubators. Also, 16 Centers of Excellences have been created as a flexible model of long-term support for highly innovative, basic and translational research to create high quality state-of-the-art facilities for R&D.Biotechnology Industry Research Assistance Council Ace Fund (BIRAC Ace Fund) which is an equity fund for accelerating entrepreneurs was announced by science and technology minister, Mr Harsh Vardhan during BIRAC Foundation Day event in Delhi recently. Clinical research The clinical research which was in shambles a year before is also slowly catching up. "Over the last few months, several steps have been taken by Indian regulators to bring clinical research in India back on track. We now need to restore confidence among all the stakeholders that robust and streamlined guidelines and systems are in place in the country for conducting clinical research," mentioned Ms Suneela Thatte, president, Indian Society for Clinical Research (ISCR) adding "Thousands of patients are desperately waiting for new therapies and drugs to enter the market, and we, as clinical research professionals, have an enormous responsibility to fulfill this need. We are fully committed to working with everyone across the clinical research spectrum to create an enabling environment which encourages scientific and ethical clinical research so that patients can have better and quicker access to new treatments."According to Dr Geeta Shroff, founder & medical director, Nutech Mediworld & India's leading stem cell expert. "During his first term in office, Modi has shown interest in stem cell research as it evident from his visit to various institutes across the country and abroad to access progress being made in stem cell research and genetics. He has reiterated the need for supporting "Indian discovery science" in order to boost national economy. Given the focus on creation of research and development in his budget, the Modi government has taken the first step to ensure that the healthcare sector gets back its confidence to grow and help in nation building."Indeed there needs to be separate policies for stem cells as they are not drugs hence should not be treated as such. It is also important that opinion of stem cell experts (those that have published and patented stem cell related work) be taken while drafting policies and not to be limited to governmental organizations.Dr Manu Jaggi draws attention to few other priority issues needed to be addressed, He explains, "Despite some of the drugs being banned internationally, a large number of drug combinations are widely sold in India without the necessary regulatory approvals,. We need to align our policy on this with other western countries. There is lack of transparency regarding government's strategy on the IPR. Despite India being TRIPS-compliant, this is sending a false signal. Further, the government is yet to share the new IPR policy." Demands yet to be met feel BioSuppliers The biosuppliers were eagerly looking at some announcement for hassle free business and rebates over import taxes of research products. Besides that, the funding allocations to research institutes were also expected to go up. But there has been no progress so far on these. Echoing the common view, Dr Vishal G. Warke, director R&D, Cell Culture and Immunology, Himedia Laboratories mentioned, "We are still waiting for the Modi government to release the funds for most of the research institutions in India, as the lack of funds and grants from the central government has adversely impacted our sector. Scientists are unable to buy a lot of reagents and products as they are still waiting for the funds to be disbursed."However, Dr Warke like his other counterparts in industry hasn't lost hope yet. He optimistically adds further, "On the whole however, the mood is very encouraging and positive with the Modi government and we feel that things should improve dramatically in the next year, in the biotech sector."The focus on non-adversarial, corruption-free and predictable policy regime is the core strength of the present government. As per critics, the first year's rule can be given full marks only in foreign policy and economics but a lot remains to be done for health, agriculture, education and science. While the Swach Bharat Abhiyan and Make in India surely are being appreciated as unique programmes but it will take a longtime to witness a visible change on ground. "India's biotechnology industry is on the cusp of entering a new era as the government focuses its efforts in building a research ecosystem that would spur medical innovation. It will take some time and too early to speculate, remarked an expert. This sums up the overall mood. Despite unmet expectations, industry seems to be hopeful of increased momentum over resolving specific issues of more regulatory clarity, business friendly environment and taxes. While the beginning has been good, this government surely has a lot to do and achieve. Perhaps industry will have to hold their horses for some more time. ]]> <![CDATA["Telehealth market in India is enormous"]]> https://biospectrumindia.com/interviews/95/6336/telehealth-market-in-india-is-enormous.html https://biospectrumindia.com/interviews/95/6336/telehealth-market-in-india-is-enormous.html Sat, 20 Jun 2015 08:47:00 +0530 Q: How do you define Telehealth and its tools? How can it transform the Indian healthcare scenario? Although, Telehealth and Telemedicine are used interchangeably but to define Telehealth in its entirety we must first understand Telemedicine. Telemedicine is used to bridge the gap between patients and provider through electronic information and telecommunication technologies where they are separated by long-distance. While Telemedicine focuses on remote diagnosis and treatment of chronic diseases, Telehealth can refer to remote non-clinical services, such as patient and professional training, skill development of healthcare providers and administrators, in addition to clinical services. So with Telehealth, focus is on health rather than illness. About the second part of the question, Telehealth has a huge potential in a country like India. Although, we have a well planned three tier public healthcare system in place, a large portion of rural Indian population is medically underserved. This is mainly due to the acute lack of care providers. While 70% of patients are from the rural areas, 75% and 23% of qualified medical practitioners are in urban and semi-urban areas respectively. To put this in perspective, Chennai has more neurosurgeons than entire North-Eastern part of India. Such a scenario only makes case for Telehealth more compelling. Since it is more cost effective and economical, Telehealth is one of the best options for healthcare services delivery for distant and remote areas. Using available telecommunication and information technology, it is quite possible for a rural dweller to consult a medical specialist without travelling to visit a healthcare facility which could be located hundreds of kilometers away. The only challenge is to integrate Telehealth in our existing healthcare system and benefit public at large. Q: How big is Indian Telehealth market and its current and future growth rate? Which are the potential growth factors? Telehealth in India is in its nascent stage so estimates vary widely. If you go by reports from some leading research firms, current size of Telehealth market in India could be anywhere between $15 million-$500 million. One thing is for certain that Telehealth market in India is enormous. Just to give an idea, about 70 percent of our population is rural, that would be at least 700 million people. Even if we could enable 10 percent of total medical consultations from rural population through Telehealth the market potential is huge. Factors which will aid Telehealth growth and adoption in India range from need of time to competitive advantage for healthcare providers. Apart from rural population, we have homebound aging/geriatric population as well that is unable to reach for medical consultation and this population is only going to increase with time. Availability of affordable technology will compensate for shortage of trained healthcare professionals and will also lead to better management of healthcare resources. Q: How can private players make the healthcare more accessible and affordable in rural settings? Is there any ongoing government programme on this? India's healthcare budget is one of the world's lowest. If you go by the survey, health expenditure by government as percentage of GDP for 2014-15 is only 1.2 percent, lowest since 2012-13. Fortunately, Telehealth in India on the other hand has been implemented under the Public-Private Partnership model which brings in significant fund from the private sector. Private sector contribution to the healthcare at approximately 74% is amongst the highest in the world. Private players can bring in tools like telecommunication hardware and software, medical equipments, videoconferencing equipments which can ease up the burden from government's shoulder. Government has to define incentives for the hospitals, telecom service providers and the patients to attract more private sector investment. Central Government as well as state governments under various healthcare program initiatives have begun implementing Telemedicine network. A budget of Rs 10 million is allotted to each state under NRHM for increasing Telemedicine nodes at district level. Q: Please tell us about the Telehealth technologies being spearheaded by Tata Elxsi and your future expectations? Currently, TATA Elxsi has developed various solutions on telehealth, more specific to connected care ecosystem. Video conferencing, connectivity protocols for device data transmission, remote monitoring of vital signs being few of them. Telemedicine initiatives are not new to TATA Elxsi, adoption of telemedicine technologies started a decade back. TATA Elxsi provided either support or the complete telemedicine solution for use cases like, physician's outreach to remote facilities and clinics, wherein physician can directly access the patient's data without travelling to the patient location. They can diagnose, monitor as well as prescribe the medical care efficiently. Moreover, the solution can be extended to assess patient remotely via videoconferencing, preventing unnecessary carriage of patient for primary care. TATA Elxsi foresees future in leveraging its connectivity expertise in integrating the various modules of connected care ecosystem such that data from the device as well as patient data can be pulled over from local aggregator as well as EMR on cloud. We also encourage the implementation of various interoperability standards and methods like HL7 and IHE to make the data accessible amongst various enterprise solutions without compromising the integrity. ]]> <![CDATA[FDA nod for Orchid's anti-bacterial drug]]> https://biospectrumindia.com/news/95/4056/fda-nod-for-orchids-anti-bacterial-drug.html https://biospectrumindia.com/news/95/4056/fda-nod-for-orchids-anti-bacterial-drug.html Fri, 19 Jun 2015 14:11:24 +0530 Chennai-based Orchid Chemicals and Pharmaceuticals has received approval from the United States Food and Drug Administration (US FDA) for generic anti-bacterial Gemifloxacin Mesylate tablets. 'The company has received approval from the United States Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Gemifloxacin Mesylate tablets in the strength of 320 mg,' the company said in a filing to BSE. The approval is with 180 days of generic drug exclusivity, it added. ]]> <![CDATA[NBRC scientists discover early diagnosis method to detect Alzheimer's]]> https://biospectrumindia.com/news/95/8259/nbrc-scientists-discover-early-diagnosis-method-to-detect-alzheimers.html https://biospectrumindia.com/news/95/8259/nbrc-scientists-discover-early-diagnosis-method-to-detect-alzheimers.html Fri, 19 Jun 2015 14:10:13 +0530 Lack of reliable technique for early diagnosis of Alzheimer's disease (AD) robs many senior citizens of their peaceful retirement years. It is a serious and escalating health concern around the globe is estimated to be affecting the lives of 5 million people around the globe by 2020 and 14 million people by 2050. Research by the National Brain Research Centre (NBRC) in collaboration with All India Institute of Medical Sciences (AIIMS), funded by the Department of Biotechnology now offers some hope. Dr Prabhat Mandal and his team at NBRC have identified a biomarker that may serve as a clue to early detection of AD. Their research work published in the US based journal Biological Psychiatry shows that regular quantification of glutathione (GSH) in the brain can help detect a potential AD patient much before the onset of the disease using a non-invasive technique called Magnetic Resonance Spectroscopy (MRS). The study conducted in collaboration with Dr Manjari Tripathi, MD, DM from Department of neurology, AIIMS showed that those suffering from the disease have reduced GSH as compared to the healthy individuals. GSH is a major endogenous enzyme-catalyzed antioxidant in the brain that plays a key role in detoxification of free radicals, which if left unsequestered can lead to oxidative stress (OS) and consequent oxidative damage in the brain. GSH regulates signaling and metabolic pathways of a variety of regulatory, structural and metabolic proteins. Due to such multifarious functions, there are considerable chances for changes in GSH levels to lead to AD. The team used MRS to quantify GSH level in specific brain regions that have been shown to be affected by AD. They recruited AD patients and those with Mild cognitive impairment (MCI), the precursor to AD, as well as age-matched healthy old individuals. A total of 40 Alzheimer's patient, 41 patients suffering from MCI and 49 healthy individuals-participated in the study. While the healthy individuals were recruited through advertisements, the patients were referred by Dr. Tripathi. GSH estimation through MRS in hippocampi, a region of the brain, of the study recruits yielded 100% specificity and sensitivity for distinguishing AD and healthy controls. At present diagnosis of AD is dependent on clinical evaluation, and is thus often possible only after severe clinical and behavioral symptoms have set in. At such late stages, management and control of the disease becomes difficult and most current therapies are ineffectual. Further, the clinical diagnosis of dementia is imprecise, especially at early stages. As such, it is critical to develop reliable technologies that are able to diagnose the disease at early stages - before the debilitating AD symptoms have set in. This would aid in arresting the disease and increasing the quality of life of the person suffering from the disorder. Another article published in the Journal of Alzheimer's disease by the same team indicated that neuropsychological screening tool for dementia in elderly person in rural and semi-urban population will be immensely helpful in promoting inclusive health care. The article highlighted the need for effective screening tool and appropriate application to be developed in India. Source: Department of Biotechnology (DBT). ]]> <![CDATA[ISAAA releases 'Voices and Views on Why Biotech?']]> https://biospectrumindia.com/reports-white-papers/95/3949/isaaa-releases-voices-and-views-on-why-biotech.html https://biospectrumindia.com/reports-white-papers/95/3949/isaaa-releases-voices-and-views-on-why-biotech.html Fri, 19 Jun 2015 14:08:05 +0530 "We need to hear the voices of those who think technology has something to offer so that these can resonate to others and be part of chorus that is able to make informed opinions and produce sustained action," states the brief by International Service for the Acquisition of Agri-biotech Applications (ISAAA). And rightly so, the agriculture biotechnology despite its tremendous benefits for improving productivity, has been caught in host of issues related to regulations and opposition from activists. The ground situation hasn't changed since last one decade and there seems to be no easy way out. As mentioned by Dr Mariechel J Navarro, director, Global Knowledge Center on Crop Biotechnology in the preface of the brief, "Voices and Views: Why Biotech?", it is a collection of personal essays on individuals from all over the world who have followed the development of biotechnology and are convinced that it has a significant role to play in improving the quality of life. The brief no. 50 from ISAAA can be downloaded from the webpage: http://www.isaaa.org/resources/publications/briefs/50/default.asp Through this brief, ISAAA has complied different key stakeholders' viewpoints, which are meant to generate interest in the field, inspire, and inform decision makers and to contribute to a better understanding of why the technology deserves attention. In the same manner, the essays pose challenges that the technology faces with the intent to bring opportunities to the surface as well as identify potential avenues for development. Thirty-two experts from Africa, Asia, Europe, and North America were interviewed face-to-face or through email by members of the biotech information network of the ISAAA. These stakeholders represent policy makers, scientists, academics, media practitioners, and farmers who are willing to have their voices heard amidst the cacophony of divergent opinions. The list includes a former science and technology adviser to U.S. Secretaries of State, a World Food Prize awardee, noted scientists, economists, journalists, and farmers from Burkina Faso, China, Egypt, India, Indonesia, Kenya, Malaysia, Pakistan, Philippines, Switzerland, Thailand, Uganda, the U.S., and Zambia. They answered these basic questions: How did you get into biotech? Is there a place or future for biotech in your country/the world? What is its impact? What are the prospects and challenges? Respondents with technical background and exposure to biotechnology enumerate many benefits of the technology - from improving yield, reducing use of pesticides and toxic chemicals, decreasing soil erosion, and diminishing agriculture's carbon footprint; while increasing the nutritive value of major crops and generally playing a vital role in improving the quality of human life. They note many studies and peerreviewed papers documenting these benefits that will contribute to meeting the food and agricultural needs of the future. One scientist, in fact, was able to get almost 4,000 scientists to sign an online declaration in support of agricultural biotechnology, of which 25 were Nobel laureates. ]]> <![CDATA["State govts need to do more for incubation"]]> https://biospectrumindia.com/interviews/95/6454/state-govts-need-to-do-more-for-incubation.html https://biospectrumindia.com/interviews/95/6454/state-govts-need-to-do-more-for-incubation.html Fri, 19 Jun 2015 08:07:00 +0530 Dr Premnath also provides leadership for the Intellectual Property Group at NCL - one of India's leading IP management groups based out of research institutions. Dr Premnath is also the director of the Venture Center (trademark of Entrepreneurship Development Center), a technology business incubator on NCL campus. Dr Premnath is also a scientist, Polymer Science & Engineering Division at NCL with an interest in technology development for biomedical products. Dr Premnath holds a BTech from the Indian Institute of Technology, Bombay and a PhD from the Massachusetts Institute of Technology, USA. He has also been a Chevening Technology Enterprise Fellow with the Center for Scientific Enterprise, London Business School and the University of Cambridge, UK. Speaking to BioSpectrum, he shares opportunities associated with Bioincubation in India and recipe to create biotech incubation boom in India. Excerpts:How to create a biotech incubation boom in India?The most important elements of a recipe to create a biotech incubation boom in India are:1. Early stage POC and technology de-risking funding: This is especially important for creating a pipeline of entrepreneurs and business ideas. (Note: This is especially important in India where most biotech entrepreneurs will be first generation entrepreneurs without strong family funding support and there is often a chasm between knowledge workers and business people.)2. Creating incubation facilities and supportive innovation ecosystems for entrepreneurs to get started.3. Creating mechanisms by which publicly funded R&D institutions can be leveraged for start-up creation and/or supporting startups. (Note: More than 80 percent of research spending in India happens in publicly funded R&D institutions.)4. Pool of highly motivated potential entrepreneurs and/or experienced entrepreneurs. What are the key ingredients needed for the success of incubation centers in India?Based on the experience of incubators who have succeeded in India, key ingredients for success are:1. Strong and continuous support of a host institution (ex: IITs, NCL), financial backers (ex: ICICI, DBT/BIRAC) or local government (ex: Govt of Kerala, Govt of AP).2. Motivated and dedicated incubation managers or key mentors.3. Location which attracts high quality scientists, engineers and entrepreneurs, or a pool of capable and ambitious people to draw from. How many incubatees are there in Venture Center?We have around 25 resident incubatees in Venture Center. What are the expectations of the incubatees from any incubation center?Different incubatees have different needs depending upon their levels of maturity, previous work experience, stage of technology development and readiness, funding already raised etc. In my opinion, the first need is often somebody to hear out the business idea without being too negative, assess the technology, provide constructive comments and suggestions and help connect with key resource people and potential team members and funding sources. Providing funding support or mentoring/referrals to help raise funding is often the next biggest need. Following this, I would rate access to facilities and other resources as a need of incubatees. Training and awareness of various aspects of technology advancement, regulatory approvals, IP management, and legal compliances are important needs but often incubatees wake up to these needs only when the need is urgent. What are the main challenges associated with creating incubation center?The main challenges:1. Balancing social goals and public assets vis-a-vis financial sustainability. Lack of stable funding sources for incubators. None or limited local government funding for incubators.2. Finding good incubation managers.3. Lack of understanding (and impatience) in many host institutions on the difficulties and time consuming nature of creating vibrant innovation ecosystems and incubation programs.4. Procedural difficulties and mechanistic hurdles in accessing experts and facilities in R&D institutions.5. Pockets of funding for early stage inventive entrepreneurs. How much investment is needed for the same?There are many different types of incubators. A few specific types are:1. Business mentoring, branding and funding (ex: IIMA, IIT-B, IKP).2. Infrastructural and specialised facilities/resources support (ex: C-CAMP, IKP, and Venture Center).3. Techno-commercial mentoring and POC funding (ex: Accelerators like InnAccel, Venture Center).4. Others including those who mix models.Investment needs for type 2 are the highest. Smaller the incubator, the greater the cost per incubatee since overheads are considerable. For rough ball park numbers: A high quality small (under <20,000 sq ft) bio-incubator in a top tier city and central location will need around Rs 4,500-5,000 per sq ft per month as set up costs and Rs 250 per sq ft per month in operational costs assuming that there is no in-kind contributions from the host institution. This does not include costs of specialized equipment and instruments needed for the facility. Can you share some of the success factors? Key success factors:1. Key person setting up and running the incubation program.2. Support of the host institution (can be academic/research organization).3. Initial funding support to incubator and entrepreneurs. Can universities create an eco-system to have 10-15 incubatees in the campus?Yes. Universities should create and operate an incubator as a strategic program --- an avenue to empower their faculty and students to pursue entrepreneurship and technology commercialization. Currently, DST-NSTEDB, BIRAC and DeitY are supporting setting up incubation centers, and universities can easily leverage these funding sources for creating new incubators. One other thing Universities need to do is to formulate suitable policies and set up institutional mechanisms to support incubation activities. Is government doing enough to promote Biotech incubation in the country?Answer to this is Yes and No. BIRAC is doing many things to help incubation for early stage start-ups. For ex, it funds almost Rs 50 lakh for 18 months to early stage start-up via the Biotech Ignition Grant scheme. On the other hand, several other government departments look for immediate success and contribution to economy. In such a situation, turnaround time is faster for IT and Services companies and so they get more attention. Bio-incubators typically take longer time to show the results. State Governments need to do more to support incubation. Do you think government should look at setting up of a body like STPI (promotes IT) for biotech sector?It will help biotech sector. IT sector is more export driven and so STPI (with an export focus) produced faster results. In biotech, equivalents of STPI need to focus on creating a longer-term pipeline of companies. We see very few companies like Biocon listing in the financial markets and creating wealth. We need more and more companies to start in this sector and grow. How do private equity investors and venture capitalists look at biotech sectors?There is growing interest. We are seeing private equity and VC funding action in Biomed, Diagnostics, and Bio IT sectors in India. ]]> <![CDATA[Pancreatic cancer treatment pipeline dominated by early-stage development]]> https://biospectrumindia.com/features/95/7777/pancreatic-cancer-treatment-pipeline-dominated-by-early-stage-development.html https://biospectrumindia.com/features/95/7777/pancreatic-cancer-treatment-pipeline-dominated-by-early-stage-development.html Thu, 18 Jun 2015 16:14:28 +0530 While the treatment pipeline for pancreatic cancer shows a high level of innovation, with 52 percent of products categorized as first-in-class, most development is in the early stages, meaning a significant proportion of therapies are unlikely to reach the market in the near future, says business intelligence provider GBI Research. The company's latest report states that while the pancreatic cancer treatment pipeline contains 447 therapeutics in active development across all Phases, compared to 209 currently-marketed products, almost 75 percent of therapies are in Phase I or earlier. According to Mr Joshua Libberton, analyst, GBI Research, 58 percent of drugs in the pancreatic cancer treatment pipeline are in the discovery or preclinical stages, 17 percent are in Phase I and 21 percent are in Phase II, leaving just 4 percent of products in Phase III of development. Mr Libberton comments: "While the Phase III portion of the pipeline is comparatively small, it is followed by a relatively large Phase II, indicating that there will be a sustained stream of products moving through the later development stages. "Despite the majority of pancreatic cancer therapy development occurring in very early stages, many of the assessed targets showed promising preclinical results and a strong alignment to known disease-causing pathways, which could translate to clinical and commercial success." The analyst adds that the high level of first-in-class development in pancreatic cancer therapeutics is a promising sign of the industry seeking innovative treatment solutions. While the current global treatment market for pancreatic cancer is comprised of 91 percent small molecules and 9 percent biologics, some 41 percent of the pipeline is formed from biologic therapies. Mr Libberton continues: "This considerable difference is in line with the industry trend of increasing biologic development, following the escalating success of biologics in other therapy areas, such as Herceptin (trastuzumab) and Avastin (bevacizumab). "Despite this growth in the biologics sector, small molecules remain dominant in the pancreatic cancer pipeline thanks to their versatility and ease of manufacture, as well as a more established understanding of their clinical properties. However, it is clear that drug developers are seeking novel approaches to pancreatic cancer treatment that differ from the present market," the analyst concludes. ]]> <![CDATA[Govt launches Rs 124 crore pharma cluster development program]]> https://biospectrumindia.com/news/95/7398/govt-launches-rs-124-crore-pharma-cluster-development-program.html https://biospectrumindia.com/news/95/7398/govt-launches-rs-124-crore-pharma-cluster-development-program.html Thu, 18 Jun 2015 13:38:00 +0530 Speaking on the occasion, Mr Ananth Kumar mentioned that the program will provide support to the Pharmaceutical industry in becoming more capable, productive and competitive. Minister said that for the common man, availability, quality and affordability of drugs and medicines is of utmost importance and the Cluster Development Program will be the key step in ensuring health security of the country. The Minister revealed that by the end of this financial year, six Pharma Clusters are likely to come up of which three will be greenfields. Mr Ananth Kumar emphasized that these Clusters will ensure adequate testing, training and affluent treatment facilities for pharmaceuticals industry. The Minister said that the Government will also come up with the Bulk Drugs Parks and the Medical Devices Parks. The minister of state for chemicals and fertilizers, Mr Hansraj Gangaram Ahir said that the Cluster Development Programme is in the interest of the nation as well as of the society. He said that the private sector is playing a lead role in the production of Generic medicines and this program will help in its holistic expansion. The secretary in the Department of Pharmaceuticals, Dr VK Subburaj said that the pharmaceutical industry is growing at 14 to 15 percent per annum and is likely to touch the figure of Rs 4 lakh crore by 2020. The sector needs due attention so that the quality can be improved and cost brought down. Dr Subburaj said that some Clusters do exist already but not on scientific basis and this programme is meant to develop Clusters in a scientific manner. The Clusters Development Programme for Pharma sector would be implemented on a Public Private Partnership (PPP) format through one time grant-in-aid to be released for creation of identified infrastructure and common facilities. The scheme is for setting up of new Clusters as well as up-gradation of existing Clusters. An amount of Rs 125 crores have been earmarked for the Central Sector Scheme for the 12th Five Year Plan. The program is expected to come with following benefits for the industry:- âˆ? Increase the competitiveness, easy access to standard testing facilities and value addition in the domestic pharma industry especially to SMEs through creation of common world class facilities.âˆ? Strengthening the existing infrastructure facilities in order to make Indian Pharma industry a global leader in pharma exports.âˆ? Reducing the cost of production by up to 20% in the clusters leading to better availability and affordability medicines in domestic market.âˆ? To help industry meet the requirements of standards environment at a reduced cost through innovative methods of common waste management.âˆ? Exploit the benefits arising due to optimization of resources and economies of scale. ]]> <![CDATA[NITI Aayog organizes consultations on innovation and entreprenuership]]> https://biospectrumindia.com/news/95/8315/niti-aayog-organizes-consultations-on-innovation-and-entreprenuership.html https://biospectrumindia.com/news/95/8315/niti-aayog-organizes-consultations-on-innovation-and-entreprenuership.html Thu, 18 Jun 2015 13:08:03 +0530 The meeting under the chairmanship of Vice Chairman of the NITI Aayog discussed initiatives to promote innovation and entrepreneurship. It was attended by Vice Chairman, NITI Aayog Dr Arvind Panagariya, Member NITI Aayog Dr VK Saraswat, CEO NITI Aayog Mrs Sindhushree Khullar, and other members of the expert committee on innovation and entrepreneurship. The meeting took place in the backdrop of announcement of establishment of Atal Innovation Mission (AIM) and Self-Employment and Talent Utilization (SETU) under the NITI Aayog by the Finance Minister in his Budget Speech for 2015-16. In order to take these initiatives forward, the NITI Aayog set up an Expert Committee, Chaired by Professor Tarun Khanna, Director, South Asia Institute, Harvard University and Jorge Paulo Lemann Professor, Harvard Business School on 21st April, 2015. In the first meeting of the Expert Committee on 1st May, 2015, a decision was taken to hold discussions with selected ministries, departments and other stakeholders who have taken initiatives to promote innovation/ entrepreneurship. This will be followed by a broader consultation process with the stakeholders in the innovation and entrepreneurship space by the NITI Aayog tomorrow on 18th June, 2015. The veterans, industry leaders and heads of prominent incubators, representatives of Industry associations, sector specific experts, service sector representatives, venture funding agencies, educational institutions and representatives of States will join the consultation process. It is expected that the deliberations will give a fillip to the initiatives to promote innovation/ entrepreneurship across the country. ]]> <![CDATA[Daiichi Sankyo's subsidiary launches four new generic drugs ]]> https://biospectrumindia.com/news/95/7371/daiichi-sankyos-subsidiary-launches-four-new-generic-drugs-.html https://biospectrumindia.com/news/95/7371/daiichi-sankyos-subsidiary-launches-four-new-generic-drugs-.html Thu, 18 Jun 2015 12:48:20 +0530 Daiichi Sankyo Company Limited has announced that on Friday, June 19, its generics subsidiary, Daiichi Sankyo Espha, will launch seven new generic drugs with four new active ingredients. The generic drugs to be launched are: 1. Naftopidil OD Tablets 25mg/50mg/75mg DSEP: indicated for the treatment of urination disorder due to enlargement of prostate (Brand: Flivas OD Tablets 25mg, 50mg, 75mg) 2. Metformin Hydrochloride Tablets 250mg/500mg MT: a Biguanide-type oral hypoglycemic agent (Brand: Metgluco Tablets 250mg, 500mg) 3. Letrozole Tablets 2.5mg DSEP: an aromatase inhibitor/postmenopausal breast cancer treatment (Brand: Femara Tablets 2.5mg) 4. Oxaliplatin I.V. Infusion Solution 200mg DSEP; additional strength of formula released in 50mg, 100mg in Dec. 2014: an anti-malignant tumor agent (Brand: Elplat I.V. Infusion Solution 200mg) Daiichi Sankyo Espha claims that the company has continued to maintain a level of quality based on the quality management standards of the Daiichi Sankyo Group. The company has undertaken the initiative to launch the world's first double-sided printing on tablets. Daiichi Sankyo Espha has contributed to innovations in formulation and labeling of drugs to make them easier to ingest. These kind of high value-added generic drugs are put forth by Daiichi Sankyo Espha as 'premium generics'. In order to respond to the risk of patient family members, particularly children, taking their medicine by mistake, a new measure has been introduced for Letrozole Tablets (postmenopausal breast cancer treatment). The new measure is called C-Guard. This PTP sheet was designed so that tablets can only be extracted if an inner sheet if slid up or down to match up with the position of the tablet, thus helping to prevent children taking the drug by mistake. ]]> <![CDATA[Allergan to acquire KYTHERA Biopharmaceuticals]]> https://biospectrumindia.com/news/95/7314/allergan-to-acquire-kythera-biopharmaceuticals.html https://biospectrumindia.com/news/95/7314/allergan-to-acquire-kythera-biopharmaceuticals.html Thu, 18 Jun 2015 12:27:45 +0530 Allergan and KYTHERA Biopharmaceuticals, have announced that they have entered into a definitive agreement under which Allergan has agreed to acquire KYTHERA in a cash and equity transaction valued at $75 per KYTHERA share, or approximately $2.1 billion, subject to the fulfillment of certain customary conditions. The fixed-value transaction consideration will be payable 80 percent in cash and 20 percent in new AGN shares issued to KYTHERA shareholders. The acquisition of KYTHERA immediately enhances Allergan's global facial aesthetics portfolio with the addition of KYBELLA (deoxycholic acid) injection, the first and only approved non-surgical treatment for contouring moderate to severe submental fullness, commonly referred to as double chin. KYBELLA is approved by the US Food and Drug Administration (US FDA). KYBELLA injection is also being developed for potential introduction into international markets; KYTHERA has submitted KYBELLA injection for regulatory approval in Switzerland, Canada and Australia, with other market applications to follow. The acquisition will also add KYTHERA's development product setipiprant (KYTH-105), a novel compound for the prevention of male pattern baldness, as well as additional early-stage development candidates. "The acquisition of KYTHERA is a strategic investment that strengthens our leading global position in aesthetics and continues to position us for long-term growth," said Mr Brent Saunders, CEO and president of Allergan. He added, "KYBELLA is an exciting new product that offers patients the first and only clinically-proven, non-surgical treatment for submental fullness (excess fat under the chin). As a leader in aesthetics, we know our customers are looking to offer their patients new options beyond traditional facial aesthetics. KYBELLA will do that while complementing our market leading facial aesthetics portfolio, which includes BOTOX, JUVEDERM XC, JUVEDERM VOLUMA XC, LATISSE and SKINMEDICA. KYBELLA is also a pivotal entry point for expanding the use of facial aesthetic products in men, while KYTHERA's setipiprant (hair-loss) development program can drive additional long-term value." "Allergan's world-class medical aesthetics, global footprint, history and commitment to developing leading aesthetic products makes them ideally suited to realize the maximum commercial potential of KYBELLA. I am deeply appreciative of the commitment and dedication of our KYTHERA team that worked so tirelessly to bring KYBELLA from early development through approval and launch. We look forward to working with Allergan to ensure a successful US launch of KYBELLA, as well as to secure additional approvals globally," said Mr Keith Leonard, CEO and president of KYTHERA. The cquisition of KYTHERA is subject to approval by the shareholders of KYTHERA, expiration or termination of the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 and fulfillment of certain other customary conditions to closing. Pending such approvals and fulfillment of other conditions, Allergan currently anticipates closing the transaction in the third quarter of 2015. JP Morgan is serving as a financial advisor to Allergan and Covington and Burling LLP is serving as Allergan's lead legal counsel. Goldman Sachs is serving as financial advisor to KYTHERA and Latham and Watkins LLP is serving as KYTHERA's lead legal counsel. ]]> <![CDATA[How to get 2000 biotech startups by 2017?]]> https://biospectrumindia.com/features/95/6074/how-to-get-2000-biotech-startups-by-2017.html https://biospectrumindia.com/features/95/6074/how-to-get-2000-biotech-startups-by-2017.html Thu, 18 Jun 2015 08:57:00 +0530 With a large number of multinational biotech and biopharma companies initiating their R&D and manufacturing operations in India, the demand for biotech incubators has increased tremendously. Companies have realized the benefits provided by these business incubators and have been relocating their facilities to the parks and other university campuses. Both the central and state governments are making all efforts to promote biotechnology endeavors in the country by setting up biotech parks, incubators as well as pilot projects. This is to encourage new entrepreneurial ventures in biotech and provide an excellent template for promotion of biotech startup companies. The central government, through DBT and BIRAC, has been providing funding support in the form of grants-in-aid, budgetary allocation and incentives for the development of biotech incubators. According to a recent FICCI report, the Indian lifesciences industry is now the third-largest contributor to reducing India's merchandise trade deficit. The industry generates around $10 billion of trade surplus every year, allowing it to neutralize around 4 to 5 percent of total energy imports for India. In addition, it also generates a significant number of jobs. FICCI estimates indicate that around 2.5 million people are currently employed by the industry (including some of the industries such as chemists, stockists, etc.). Trends and methodsWith all these positive trends can India have another 2,000 startups by 2017? Certainly. Let us look at how? "The current biotech start-up environment is very good and conducive. When it comes to investments, it is not like the software industry. Venture capitalists indeed invest in lifesciences start-ups. It takes time to see the returns. Most areas in the Lifesciences are happening right now. Especially, in the areas of genomics and bioinformatics," said Mr Shrikumar Suryanarayan, chairman and co-founder, Sea6 Energy. Meanwhile, BioSpectrum conducted a survey on the current incubators of lifesciences companies in India and their role in incubating a lifescience company. These incubators provide the lab space, needed infrastructure and mentorship to all the incubatees. It was discovered that India has over 250 academia, biotech parks and incubator facilities across the country. It just needs each of them to support 10 start-ups as incubatees in their premises. The goal to reach 2,000 start-ups can be achieved."Long-term venture capital and availability of physical infrastructure are no doubt the key ingredients for biotech start-ups to test ideas and build technologies. However, even more critical is the availability of right mentors and right advice at key stages of incubation," said Dr Guhan Jayaraman from IIT-Madras. Further he added, Bio-incubators (and BIRAC) need to identify such people and enlist their support for mentoring start-up companies. Established biotechnology industries also need to form a support structure (e.g., a consortium or a corpus fund), wherein they can mentor or financially support (in exchange for equity) start-up companies. Finally, a concerted effort needs to be made in manpower training and development, especially for industrial biotechnology. These should include post-finishing schools in biotechnology and entrepreneur development, he added.Creating a large number of biotech start-ups is not the main requirement, as is creating many successful start-ups with innovative technologies. So, identification of such start-ups, providing them long-term venture capital and mentoring them at key stages is more important than providing the investment for a large number of start-ups.We need at least 50 incubation centers, each having a capacity to incubate 40 high potential start-ups, felt Dr Jitendra Kumar, director and head, Bangalore Bio innovation Center (BBC). "Considering the cost of setting up one incubation center as Rs 50 crore, we must have dedicated capital resource of Rs 2,500 crore to achieve the target. This number excludes the incubators that are already existing, but I think we must create an incubator support fund of this quantum. We also need to have dedicated funds for seed funding the incubatees through grants/soft loans and equity funds," he added. Shortcomings"All incubators do have shortcomings. Getting the right support also depends on the incubation centers and how well they are equipped to handle the incubatees," said Mr Suryanarayan. For instance, he provides the example of C-CAMP. "C-CAMP is embedded in a cluster. There is a lot of access to rich ecosystem of scientists and professionals, infrastructure, and the management has been extremely proactive. There is no bureaucracy. It is totally a different environment from how the government operates. We need more BIG and BIPP programs, because that's from where start-ups will arise. There should be more industry-academia tie-ups and similar programs that encourage start-ups to flourish. Currently, there is a tendency to not engage start-ups /entrepreneurs while setting up the facilities, or formulating policies. "So their representation must improve to create real impact. Also, Incubation centers have not been institutionalized properly in the Indian scenario. Most of the incubators in India run on project mode, with no dedicated funds, no autonomy or no career paths for incubation managers. So, the activity runs on the fringes and never is a mainstream activity," felt Dr Jitendra Kumar."Integrating / introducing IT-enabled research support to reduce cost and time in the traditional wet lab model; formal linkages with academic expertise through rewards and incentives and aggressive alignment with Angels and VC investors, are some of the areas where incubators need to improve," felt Mr A Balachandran, GM, VIT-Technology Business Incubator, VIT University, Vellore.Incubation modelVIT University, Vellore provides concept-to-commercialization support and incubation support for biotech start-ups. It is heavily anchored on 'Access to infrastructure in the campus', 'Access to Talent', 'Access to Mentoring & Funding'. "Though our standard incubation period is three years, on a case-to-case basis, we extend this support up to five years too. Our funding assistance comes without hassles as it is a soft loan without any equity demand. We do bring in mentors and angel investors from our network to assist our start-ups in areas where we don't have resources in-house," said Mr A Balachandran.At Bangalore Bioinnovation Center (BBC), the prospective incubatees are selected through a rigorous process. It is ensured that incubatees who are selected score high on innovation, social impact, team strength, and have a clearly laid out robust business model. These Incubatees are provided with subsidized infrastructure/common equipment facility, focused mentorship, seed fund, access to venture fund, logistics for future growth plans/scale up, branding and networking support. BBC also plans to engage in building a robust pipeline of technology entrepreneurs through different institutional means such as live business plan competition, and forming teams around IP protected technologies which are lying bare on shelves in research institutions. "The center is promoted by the Karnataka Biotechnology and Information Technology Services (KBITS), which is a nodal center of the department of IT, BT and S&T, Govt of Karnataka. The center has received generous funding support from DBT. Structured as Section 8 not-for-profit company, it aims to spur innovation movement in lifesciences in the State and beyond," said Dr Jitendra Kumar of BBC.The IITM Bioincubator is a part of the IIT Madras Incubation Cell and is housed in the IIT Madras Research Park. It is currently funded by BIRAC and incubates only start-up companies in biotechnology. Start-ups who are interested in being incubated have to apply through the website with a brief proposal. They will be called for a presentation before the Bioincubator Screening Committee consisting of academics, entrepreneurs, scientists from industry and medical institutions. The committee selects them based on five criteria: Technical merit of the proposal, business strategy for commercialization, team expertise, availability of seed-funding or venture capital and compatibility with the infrastructure and space available in the bioincubator. The selected companies are allowed to incubate for an initial period of 2 years which is extendable, depending on progress and financial sustainability of the incubated company and other assessment criteria. The IITM Bioincubator provides a comprehensive wet-lab facility consisting equipment for microbial/cell culture, bioprocess engineering, molecular biology and analytics. It also provides technical services and, through the IITM Incubation Cell, it provides the incubated companies with legal, accounting and other non-technical services. It also connects the incubated companies with a mentor network consisting of academics, biotech entrepreneurs, industry experts and venture capitalists. In addition, the IITM Bioincubator also provides linkages with other Institutions, and incubation centers for using specialized facilities not available at the IITM Bioincubator. "Being incubated in an academically-linked ecosystem also provides start-up companies with a rich resource of faculty mentors, and students who can be hired for internships and employment. The IITM Bioincubator does not by itself provide seed funding," said Prof Guhan Jayaraman.How to kick start biotech startups boom in India?The Govt (BIRAC), industry and academia need to be more holistically involved in this process to streamline the functioning of bio-incubators, identify promising companies or technologies which require support and minimize chances of failure. There needs to be a thorough understanding of the bio-incubation process and factors which will give better chances of commercial success, felt Prof. Guhan Jayaraman. "Finally, the bio-incubators need to be located in an ecosystem where there is a rich mix of industry-academia interaction and a diverse set of start-up companies," he added.Relevant department in every state should create such centers either through their own resources or through PPP mode. However, such centers should either be co-located with academic institutions or should be within an industrial cluster or both, felt Dr Jitendra Kumar of BBC. "BBC has the advantage of being located within an upcoming Bangalore Helix Biotech Park. The park already has within its campus reputed academic institutions like Institute of Bioinformatics and Applied Biotechnology (IBAB) and Centre for Human Genetics (CHG). Bio-Industry cluster building is under process. BIRAC like institutions and its schemes at State level is also an important requirement for scaling up the start-up movement in biotechnology in India.""In my opinion, we need 100 specialized infrastructure zones that are to be created for incubation. These zones should have basic biotech product development and testing facility. The cost for this could be around Rs 500 crore. For every 5 such incubators, there could be one animal house facility and for every 10 such incubator, there could be a sequencing facility as common facility. Since relying on only campus facility leads to either delays or limited access to infrastructure, such dedicated facilities are essential," said Mr A Balachandran.As FICCI puts it, India's lifesciences industry has traversed a successful journey in the past 50 years. From an era of import dependency in the pre-1970s, high-quality local players moved the country toward self-sufficiency in lifesciences by the 1990s. Since then, world class capabilities have helped the Indian industry build a strong global presence. In this journey, the industry has achieved several successes and has contributed significantly to the Indian economy and healthcare outcomes, in both India and abroad. The government could consider supporting this journey by creating a conducive environment for the industry to undertake start-up boom for the benefit of mankind. ]]> <![CDATA[â€œMake biologics in Indiaâ€? slogan reverberates in BIO ]]> https://biospectrumindia.com/news/95/7546/make-biologics-in-india-slogan-reverberates-in-bio-.html https://biospectrumindia.com/news/95/7546/make-biologics-in-india-slogan-reverberates-in-bio-.html Wed, 17 Jun 2015 17:22:00 +0530 Philadelphia, 17 June 2015: As nations and various states in the US competed for biotech industry attention at the annual BIO International Convention here, India too was all over the place with four back-to-back sessions showcasing the research and innovation capabilities, Make in India initiatives to ensure ease of business, regulatory changes to make things easy for biotech companies and above all the talent powerhouse that the country is. " There is a global capacity shortage in biological manufacturing building up as demand goes up due to increased access. India has shown world class biological manufacturing can be done in vaccines and other therapeutic products. Now India is a compelling place to invest and fill the rising demand gap," said Dr Kiran Mazumdar-Shaw, Chairman, Biocon and head of CII's India biotech delegation. In fact, she showcased India's biotech capabilities at four different sessions during the day and answered a wide range of questions from potential investors, flanked by senior government officials and industry leaders. In the absence of S&T minister, Dr Harsh Vardhan's at the convention, Dr Kiran filled in admirably. Two senior officials, Mr Sreeshan Raghavan from Department of Biotechnology and Dr M Ariz Ahammed from the Department of Pharmaceuticals, rolled out the highlights of the Make in India program and traced the recent regulatory changes that are removing some of the hurdles in the path of clinical trials in India in the last three years. " A time bound approval process has been put in for clinical trials," said Dr Ahammed. Similarly, the governments has also streamlined the drug approval process by roping in more than 150 subject matter experts instead of a single Drug Advisory Committee to clear proposals quicker. The slowdown in clinical trial approval process has been a sore point for foreign companies. This came up in all the India sessions. GSK's vice president for South Asia, Mr Hasit Joshipura pointed out his company's successful manufacturing and research facilities that existed in India for more than 50 years and how India has been a major strategic part of the company's global operations. "In fact, drug approvals used to be very fast 12-18 months in India few decades back. Then the pendulam swung the other way slowing down the process over many compelling reasons. Now things are swinging back but not to the original time lines, " Mr Joshipura said. Industry minister of Telangana, Mr Jupally Krishna Rao and special secretary, K Pradeep Chandra and Mr C V Shankar, additional chief secretary of Tamil Nadu, also participated actively in all the panels and highlighted the recent government initiatives. Minister Mr Rao inaugurated the India Pavillion at the Exhibition which had the Make in India theme this time. He also released the India Biotechnology Handbook brought out by BioSpectrum along with industry associations CII and ABLE and the Department of Biotechnology(DBT). Industry leaders from India and US also participated in a closed door meeting under the aegis of India-USA bilateral discussions which is an annual feature. The US India Business Council and Pfizer facilitated the discussion with the Indian delegation. The meeting decided to follow up some of the key issues that came up for discussion and ensure swift action takes place. ]]> <![CDATA[FVI announces final close of fund II at Rs 100 crore]]> https://biospectrumindia.com/news/95/7208/fvi-announces-final-close-of-fund-ii-at-rs-100-crore.html https://biospectrumindia.com/news/95/7208/fvi-announces-final-close-of-fund-ii-at-rs-100-crore.html Wed, 17 Jun 2015 14:54:24 +0530 The fund which was originally targeted at Rs 85 crore focuses on early growth opportunities, predominantly in the healthcare and pharmaceutical sectors. Announcing the final close of Fund II, Mr Krishna Ramanathan, founder partner, Fulcrum Venture India, said, "We view this space as a sunrise area for PE investments and with our operational expertise, can bring in a lot of value to the companies we work with." Fulcrum Venture India Fund II, which had achieved its first close at Rs 60 crore in 2013, has already invested in Richfeel; a pioneering retail trichology company in India and Shield Healthcare, a pharmaceutical company focused on gynecology. Unlike its first fund, where the focus was seed stage investments of up to Rs 5 crores, Fulcrum Venture India Fund II typically seeks to make investments between Rs 5 to 15 crore in early growth stage companies. Commenting on the current investments, Mr Krishna also said, "The investments thus far have been growing very well and we're happy to see approaches from other PE firms, where up rounds are coming in at attractive valuations. This is a good sign that our strategy is well placed." He also added, "While it's too early to see any exits, we are likely to see some of them in the market for the next round fairly soon. This could be as early as Q4 this year." Fulcrum Venture India was established in 2000, predominantly making seed stage investments into pharmaceutical and healthcare companies. ]]> <![CDATA[Suven secures patents for its Neurodegenerative Drug]]> https://biospectrumindia.com/news/95/6436/suven-secures-patents-for-its-neurodegenerative-drug.html https://biospectrumindia.com/news/95/6436/suven-secures-patents-for-its-neurodegenerative-drug.html Wed, 17 Jun 2015 11:08:32 +0530 Suven Life Sciences (Suven) has announced the grant of a product patent from Israel (198821), one product patent from Macau (J/001515) and one (1) product patent from USA (9018231) corresponding to their New Chemical Entities (NCEs) for the treatment of disorders associated with Neurodegenerative diseases. The granted claims of the patents include the class of selective 5-HT compounds discovered by Suven and are being developed as therapeutic agents and are useful in the treatment of cognitive impairment associated with neurodegenerative disorders, like Alzheimer's disease, Attention deficient hyperactivity disorder (ADHD), Huntington's disease, Parkinson and Schizophrenia. With these new patents, Suven has a total of five (5) granted patents from Israel, four (4) granted patents from Macau and twenty one (21) granted patents from the USA. "We are very pleased by the grant of these patents to Suven for our pipeline of molecules in CNS arena that are being developed for cognitive disorders with high unmet medical need with huge market potential globally," said Mr Venkat Jasti, CEO of Suven. ]]> <![CDATA[Bill Clinton slams high prices of biotech drugs]]> https://biospectrumindia.com/news/95/4400/bill-clinton-slams-high-prices-of-biotech-drugs.html https://biospectrumindia.com/news/95/4400/bill-clinton-slams-high-prices-of-biotech-drugs.html Tue, 16 Jun 2015 17:20:00 +0530 Philadelphia, June 16, 2015: Former US President Bill Clinton asked biotechnology industry to relook at the high prices such as the $ 1000 a pill for hepatitis C drug Sovaldi and Harvoni and the industry has to have a better explanation for such sky high prices. " Explain, explain, explain and disclose, disclose, disclose," Mr Clinton told a select gathering of biotechnology industry leaders at a special session organized by Klick Health, a Toronto-based digital marketing agency along with the Biotechnology Industry Organization (BIO) of US. The meeting was held at the National Museum of American Jewish History. " Don't expect everybody to love you , but at least they will hear your side of the story," said Mr Clinton according to a report in the local newspaper, Philadelphia Inquirer. Mr Cllinton has been a passionate supporter of biotech industry which regularly refers to the push he gave as President while unveiling the Human Genome Map in June 2000. Mr Clinton had delivered a key note address at the annual BIO meeting recently. And in 2014, Mrs Hillary Cllinton, a US Presidential contestant for 2016, was a key note luncheon speaker at the BIO event in San Diego. There has been growing criticism of the $1000 per pill or $ 84,000 for a full 12-week treatment to cure hepatitis C developed by Gilead Sciences, California. Most American insurance companies are denying this breakthrough treatment to patients who need till they reach the critical liver damage stage. American patients are flocking to India where the treatment is available for approximately $12 per pill under a Gilead's licensing arrangement with a dozen India pharma companies who manufacture Sovaldi, used in the treatment locally. " Who wants to let somebody's liver rot? Nobody," Mr Clinton was quoted as saying. " Who has got $80,000 to spend? Not many. And if you are small businessperson and you are in a small pool of employers based insurance, are you going to fire somebody who needs that treatment? These are all practical problems, and we can solve them," Mr Clinton said, reported Philadelphia Inquirer. ]]> <![CDATA[Avesthagen to introduce migraine gene therapy with Australian technology]]> https://biospectrumindia.com/news/95/8177/avesthagen-to-introduce-migraine-gene-therapy-with-australian-technology.html https://biospectrumindia.com/news/95/8177/avesthagen-to-introduce-migraine-gene-therapy-with-australian-technology.html Tue, 16 Jun 2015 17:02:10 +0530 Philadelphia, 16 June 2015: A gene-based therapy is on the way to reduce the suffering of at least a third of migraine sufferers with India's Avesthagen licensing a gene-based solution develop by Prof Lyn Griffiths and team at the Genomics Research Center of Australia's Queensland University of Technology (QUT). Bangalore-based Avesthagen will test the vitamin based therapy developed by Australian researchers on India's dwindling Parsi population through its Avestagenome project of mapping the community and introduce the therapy in India and elsewhere soon. Said Prof Griffiths who is also executive director of QUT's Institute of Health and Biomedical Institute: " At IHBI we are getting a great understanding of genetic make up and disease susceptibility because of expertise in genome and transcriptome analysis. We need Avesthagen's inputs to turn that into a therapy that people around the world can trust and use." The collaboration announcements was made during the ongoing BIO Philadelphia, the annual biotechnology meeting. The therapy targets a specific gene linked to aura, a deliberate type of migraine involved in neurological disturbance and blurry vision. This particular type affects about 30 per cent of migraine sufferers. The Australian researchers tested the use of a specific type of Vitamin B to mitigate the suffering. " We have been able to finally come together with QUT team on this important problem and opportunity to understand migraine better and take the lab to the bedside. The diagnosis of a particular marker linked to a therapy is unique and we are excited to bring the technology to the Indian diaspora and provide diagnosis for the neglected migraine," said Dr Villoo Morawala-Patell, chairman of Avesthagen.Avesthagen has been focused on genomics research since it was founded 15 years ago and the Australian team has been researching on migraine for the past 20 years. ]]> <![CDATA[400 mn do not have access to essential health services: World Bank]]> https://biospectrumindia.com/news/95/6815/400-mn-do-not-have-access-to-essential-health-services-world-bank.html https://biospectrumindia.com/news/95/6815/400-mn-do-not-have-access-to-essential-health-services-world-bank.html Tue, 16 Jun 2015 15:35:50 +0530 The report also says that 6 percent of people in low- and middle-income countries are tipped into or pushed further into extreme poverty because of health spending. "The world's most disadvantaged people are missing out on even the most basic services," says Dr Marie-Paule Kieny, assistant director-general, health systems and innovation, at the World Health Organization. "A commitment to equity is at the heart of universal health coverage. Health policies and programmes should focus on providing quality health services for the poorest people, women and children, people living in rural areas and those from minority groups". The report, Tracking Universal Health Coverage, is the first of its kind to measure health service coverage and financial protection to assess countries' progress towards universal health coverage. "This report is a wakeup call: It shows that we're a long way from achieving universal health coverage. We must expand access to health and protect the poorest from health expenses that are causing them severe financial hardship," says Dr Tim Evans, senior director of health, nutrition and population at the World Bank Group. The report looked at global access to essential health services-including family planning, antenatal care, skilled birth attendance, child immunization, antiretroviral therapy, tuberculosis treatment, and access to clean water and sanitation-in 2013, and found that at least 400 million people lacked access to at least one of these services. The report also found that, across 37 countries, 6 percent of the population was tipped or pushed further into extreme poverty ($1.25/day) because they had to pay for health services out of their own pockets. When the study factored in a poverty measure of $2/day, 17 percent of people in these countries were impoverished, or further impoverished, by health expenses. "These high levels of impoverishment, which happen when poor people have to pay out of pocket for their own emergency health care, pose a major threat to the goal of eliminating extreme poverty," says Dr Kaushik Basu, SVP and chief economist at the World Bank Group. "As we transition to a post-2015 development era, we must act on these findings, or the world's poor risk being left behind." WHO and the World Bank Group recommend that countries pursuing universal health coverage should aim to achieve a minimum of 80 percent population coverage of essential health services, and that everyone everywhere should be protected from catastrophic and impoverishing health payments. "As more countries make commitments to universal health coverage, one of the major challenges they face is how to track progress," says Dr Ties Boerma, director of the department of health statistics and information systems at the World Health Organization. "The report shows that it is possible to quantify universal health coverage and track progress towards its key goals, both in terms of health services and financial protection coverage." This is the first in a series of annual reports that WHO and the World Bank Group will produce on tracking progress towards UHC across countries. "As the saying goes, 'what gets measured, gets done.' With countries around the world taking steps to provide universal health coverage, the ability to identify gaps and effectively measure progress will add critical momentum to this global movement," says Mr Michael Myers, MD at The Rockefeller Foundation. "This an important tool for countries to achieve universal health coverage and build more resilient health systems." The Rockefeller Foundation and the Japanese Ministry of Health supported this report. ]]> <![CDATA["Quality focus could make Indian firms favorites of global regulators"]]> https://biospectrumindia.com/interviews/95/8087/quality-focus-could-make-indian-firms-favorites-of-global-regulators.html https://biospectrumindia.com/interviews/95/8087/quality-focus-could-make-indian-firms-favorites-of-global-regulators.html Tue, 16 Jun 2015 14:15:00 +0530 Q: Please tell us in brief about the major insights from the recent EY report on data frauds? Are Indian firms among most affected? EY's Fraud Investigation & Dispute Services team recently conducted a survey on 'Analysing the state of Data Integrity Compliance in the Indian Pharmaceutical Industry'. Some of the highlights of the survey are, 30 percent of respondents' received inspectional observations by global regulators in the last three years; 57 percent of the employees agreed to have seen work pressure on the manufacturing personnel to meet KPIs; 28 percent of respondents indicated that their organisations did not have a whistle blowing mechanism in place; 18 percent do not have adequately staffed Quality Assurance to witness and review the manufacturing and testing of all the products independently; 72 percent users in the Quality Control (QC) department have IT administration rights for laboratory systems such as HPLC, GC, etc., (This enables QC personnel to create, delete or modify data at their discretion) and 25 percent were unaware of the 21 Code Federal Regulation (CFR) Part 11 standards prescribed by the US FDA. I am sure such issues are present outside India as well. Q: Why does data integrity remain a challenge even now for the drug discovery companies? Is the GMP compliance really so tough or there are other factors involved? Nothing is tough or impossible; and challenges faced by the pharmaceutical sector are not unsurmountable. However, one issue seen when conducting data integrity reviews is the lack of understanding among people at the ground level. While companies often have extensive training programs, measuring the efficacy of those trainings is often missed. For example, did the machine operator (local language specialist) clearly understand the training consultant (an English speaking, a former regulatory inspector) about the importance of equipment validation? How well did he comprehend the concept and the requirement? It is important to bring in a cultural and monitoring change which emphasizes on quality and compliance. It should also remind the sector about the presence of proactive periodical data integrity reviews, which like an industry watchdog can detect any data integrity issues. Q: What can be the possible solutions? Has technology yet not been able to create effective tools to tackle this issue? As mentioned before, engaging in proactive periodical data integrity reviews will enable companies to identify any potential problems quickly. For instance, is the problem due to the product's formulation; is analytical testing method not appropriate for the test; the trials need to be performed only when a certain equipment is in use etc. These are some of the questions which data integrity reviews can help to answer. Once the problem is identified, companies can focus their efforts on investigating the root cause, followed by putting an effective Corrective Action Preventive Action (CAPA) in place. Post implementation of a CAPA, it is also important to conduct a follow-up data integrity review after 75 to 90 days to gauge its effectiveness. Adding a robust and effective technology enabler for instance, ensuring that the required equipments are 21 CFR Part 11 compliant and are regularly monitored for anomalies, if any, will additionally act as a strong door keeper. Q: Report says, funding a major challenge for the government regulator such as CDSCO. What kind of adverse impact can it have on the product quality? Industry sources say that the CDSCO has asked the Indian health ministry to release the USD 2.9 billion which has been allocated to the department of pharmaceuticals under the Twelfth Five Year Plan. This was to fortify its regulatory mechanism at the Central and State level regulatory bodies. Any investment made into the sector will be beneficial to the industry and the harmonization of global regulatory requirements will take place sooner or later. The industry should also maintain highest levels of quality and compliance at all times - this way, companies will continue to be favorable in the eyes of global regulators. Q: Where does the future lie and what is the way forward on the issue? The pharmaceutical industry acknowledges the issues around data integrity and is dealing with it proactively. Several companies are upgrading the technical systems in Quality Control laboratories and are investing in employee trainings. In fact, over one third of the data integrity reviews done by EY Fraud Investigation & Dispute Services are now proactive. So it is only a matter of time, a few years of continuous change and hard work on this commitment to quality and compliance, by when the industry will emerge successful. ]]> <![CDATA[PPD inks pact with HealthCore]]> https://biospectrumindia.com/news/95/6132/ppd-inks-pact-with-healthcore.html https://biospectrumindia.com/news/95/6132/ppd-inks-pact-with-healthcore.html Tue, 16 Jun 2015 12:54:56 +0530 Pharmaceutical Product Development(PPD) and HealthCore, have established a collaboration that will enable both companies to further expand their services in the pre- and post-approval research market. The collaboration combines PPD's clinical trial design, health economics and outcomes research (HEOR), medical affairs research and epidemiology services with HealthCore's strengths in HEOR, innovative real-world research designs and its robust research-enabled electronic health care data environment. "The goals of optimizing reimbursement and increasing payer and patient value are becoming more dependent on biopharmaceutical companies' ability to provide high-quality evidence of how products will perform for patients in a real-world setting," said Mr Michael Pollock, vice-president of real-world outcomes at PPD. He said, "With the collaborative expertise of PPD and HealthCore, particularly in planning, designing and implementing pragmatic clinical trials, we hope to set a new standard for the quality, cost and speed of real-world evidence generation that can help optimize patient outcomes and enable our clients to better demonstrate the true value of their products and the return on their investments in new product development." The collaboration allows lifesciences companies to engage in one contract with combined services from PPD and HealthCore that has the potential to cover product research in both pre- and post- approval settings. Both PPD and HealthCore will be able to provide biopharmaceutical companies analyses of medical claims data and electronic health records necessary to understand the utilization and impact of their products and to design appropriate pragmatic clinical trials that address payers' needs. "By combining clinical and economic information and leveraging our access to large health care provider networks, we will have a much more robust view of how patients use and react to different therapies," said Mr Marcus Wilson, president of HealthCore. He added, "This gives us an opportunity to produce relevant information that can facilitate decisions and speed to market those products that provide the most value to patients, payers and life sciences companies alike." ]]> <![CDATA[Avesthagen partners with Queensland Australia ]]> https://biospectrumindia.com/news/95/6342/avesthagen-partners-with-queensland-australia-.html https://biospectrumindia.com/news/95/6342/avesthagen-partners-with-queensland-australia-.html Tue, 16 Jun 2015 11:58:00 +0530 Avesthagen announces collaboration with Queensland University of Technology (QUT). Avesthagen will license QUT technology based on the work of QUT's Institute of Health and Biomedical Innovation, specifically in using a specific gene targeted vitamin therapy to reduce migraine frequency, severity and pain. The company will validate the migraine marker in the Parsi population through its Avestagenome Project along with the specific gene targeted therapy. The migraine diagnostic and targeted vitamin therapy will be launched in India with the migraine tests being done at AQUAS, a testing, diagnostic and services company, a subsidiary of Avesthagen. The targeted therapy will be marketed by Avesta Nordic, a preventive healthcare and nutrition company of Avesthagen. IHBI executive director Professor Lyn Griffiths leads the research team, which showed in two clinical trials that vitamin use reduced migraine disability, frequency and severity in sufferers of this common neurological disorder. The collaboration with Avesthagen will enable the researchers to translate their findings into a diagnostic and a therapeutic that can improve the lives of people with migraine. It will also enable the development of a safe and effective pharmaceutical vitamin therapy that can be cheaply produced at industrial quantities. IHBI researchers and Avesthagen will also pursue linked funding opportunities from the Australian and Indian governments to undertake further migraine genetics research. Prof. Griffiths heads the Genomics Research Centre, with researchers investigating the genetic and environmental factors involved in common chronic disorders. The Center has been involved in migraine genetics research for nearly 20 years and has identified a number of genes involved in migraine development. The new treatment is targeted to the MTHFR gene and has been shown to be particularly effective in people with migraine with aura, a common sub-type of migraine that usually involves neurological disturbances, such as visual changes, before the head pain onset. Prof. Griffiths said the collaboration with Avesthagen kept IHBI at the forefront of a developing research area in personalised medicine. 'Personalised medicine is about using genetics to understand each person's makeup, including their disease susceptibility, and finding the best treatment for that person,' she said. She added, 'At IHBI, we are gaining a great understanding of genetic makeup and disease susceptibility because of expertise in genome and transcriptome analysis. We need Avesthagen's input to turn that into a therapy that people around the world can trust and afford.' Dr Villoo Morawala-Patell, founder and CMD, Avesthagen said this relationship with Griffiths was of long standing. She said, 'We have been able to finally come together on this very important project and opportunity to understand migraine better, and take the lab to the bedside. The diagnosis of a particular marker linked to a therapy is unique and we are excited by this opportunity to work with Australia, QUT and with Professor Lyn Griffiths to bring the technology to the Indian diaspora and provide a diagnosis and treatment for the neglected migraine condition.' ]]> <![CDATA[CSIR must commercialize at least 12 technologies each year: Minister]]> https://biospectrumindia.com/news/95/6131/csir-must-commercialize-at-least-12-technologies-each-year-minister.html https://biospectrumindia.com/news/95/6131/csir-must-commercialize-at-least-12-technologies-each-year-minister.html Mon, 15 Jun 2015 12:04:00 +0530 Addressing a two day 'Director's Conference' of CSIR, being held at CSIR-IIP, Dehradun on the second day (June, 13), the minister of state for science and technology, Mr Y S Chaudhary mentioned that 10 to 15 spin off startup companies should emerge every year from industrialization of CSIR research projects. The minister said as of now there is a perception that our scientific research is not being guided by national priorities. Mr Chowdary called upon all CSIR labs to map their resources, list out bottlenecks and anomalies to bring about a positive change and come up with a vision document for a guided action now. He urged directors of the CSIR to come up with at least 12 cutting edge technologies which are to be commercialized every year. Earlier the union minister for science and tecchnology, Dr Harsh Vardhan chairing the two day conference, heard all presentations from various CSIR Institutes. He pointed out that a brainstorming session towards the end of the conference would identify various projects to be taken up by CSI Institutes for the welfare of poor and for a bright future of India as envisaged by the Prime Minister. The director general, CSIR, Mr M O Garg and various directors from all CSIR Institutes attended the conference. ]]> <![CDATA[DBT to support leads in marine biology product development]]> https://biospectrumindia.com/news/95/4763/dbt-to-support-leads-in-marine-biology-product-development.html https://biospectrumindia.com/news/95/4763/dbt-to-support-leads-in-marine-biology-product-development.html Mon, 15 Jun 2015 11:54:59 +0530 Given the excellent potential of marine biology for development of commercially viable products, the department of biotechnology (DBT) has proposed to invite concept notes from the scientists who have visible and potential leads identified from the marine sources, either individually or in collaboration through a team or institutions. DBT has been supporting programmes in the area of Aquaculture and Marine Biotechnology, both of strategic and applied nature. As per DBT, the concept should focus on biotechnological intervention for production of high value seaweeds for day to day use, green technology enzymes and chemicals from marine bioresource, biomaterials from marine bio resource and novel product from extremophiles. The research should be proposed with the available leads, identified and evaluated for different activities from marine sources for further characterization and up scaling through appropriate industry involvement. Thus concept should be based on the expertise of marine biology, chemists and others for finer characterization of the known molecules. Equally, the team can also involve bio informatics specialists as wellthe interested industry. The concept note received will be examined through the steering committee on Joint DBT and MoES Programme on Marine Natural Products constituted for the purpose. The concept notes should be submitted on the above identified areas giving emphasis on the proposed product, bioactive molecules, process development and future research for further characterization and up scaling. The concept note can be submitted by R&D organizations individually or in collaboration with industrial partners, if required. Only short listed concept notes will be invited for submission of detail proposals for financial support as per the modalities of the department. The soft copy of the concept note can be submitted to DBT before 31st July, 2015 in the prescribed format. ]]> <![CDATA[FDA approves Orchids' generic drugs]]> https://biospectrumindia.com/news/95/6130/fda-approves-orchids-generic-drugs.html https://biospectrumindia.com/news/95/6130/fda-approves-orchids-generic-drugs.html Mon, 15 Jun 2015 11:50:04 +0530 Orchid Chemicals and Pharmaceuticals has received the United States Food and Drug Administration (US FDA) approval for generic Rivastigmine capsules and Felodipine extended release tablets aimed at treating mild to moderate dementia and hypertension, respectively. The company has received approval from the US FDA for the Abbreviated New Drug Application (ANDA) for Rivastigmine capsules in 1.5 mg, 3 mg, 4.5 mg, 6 mg strengths and Felodipine extended release tablets in 2.5 mg, 5 mg, 10 mg strengths, the company said in a filing to the BSE. ]]> <![CDATA[Glenmark's new generic drug gets FDA nod ]]> https://biospectrumindia.com/news/95/6191/glenmarks-new-generic-drug-gets-fda-nod-.html https://biospectrumindia.com/news/95/6191/glenmarks-new-generic-drug-gets-fda-nod-.html Mon, 15 Jun 2015 11:49:11 +0530 Glenmark Pharmaceuticals (Glenmark) has been granted final approval by the United States Food and Drug Administration (US FDA) for the extended-cycle oral contraceptive, Levonorgestrel/Ethinyl Estradiol Tablets USP, 0.15 mg/0.03 mg, the AB-rated generic version of Seasonale by Teva Women's Health. Seasonale is indicated for the prevention of pregnancy in women who elect to use oral contraceptives as a method of contraception. According to IMS Health sales data for the 12 month period ending April 2015, the Seasonale market achieved annual sales of approximately $53.7 million. This approval marks Glenmark's 12th oral contraceptive and second extended-cycle oral contraceptive authorized for distribution by the US FDA. The company plans to commence shipping of Levonorgestrel/Ethinyl Estradiol Tablets, 0.15 mg/0.03 mg immediately. ]]> <![CDATA[Proton therapy cancer cure now in India: Philips Healthcare & IBA ink deal ]]> https://biospectrumindia.com/news/95/8248/proton-therapy-cancer-cure-now-in-india-philips-healthcare-iba-ink-deal-.html https://biospectrumindia.com/news/95/8248/proton-therapy-cancer-cure-now-in-india-philips-healthcare-iba-ink-deal-.html Mon, 15 Jun 2015 11:47:21 +0530 With an aim to provide enhanced access to proton therapy for cancer treatment in India, the Royal Philips, a leader in image-guided therapies and IBA (Ion Beam Applications S.A., EURONEXT), world's leading provider of proton therapy solutions on June 12, 2015, announced the signing of an exclusive agreement. The alliance combines Philips' expertise in clinical informatics and innovative imaging techniques for therapy planning and guidance and IBA's strengths in proton therapy. As per Mr Sameer Garde, president, Philips Healthcare, "We are very pleased to announce that Philips India and IBA are introducing the best-in-class proton beam therapy for cancer patients in India. We are confident that the future launch of the first proton therapy center in Apollo Hospitals, Chennai, will mark the beginning of a new phase in cancer treatment in the country and also the subcontinent". When asked by the BioSpectrum, Mr Garde revealed that the cost of the therapy would remain between Rs 20-22 lakh per patient to treat the primary cnacers (stationary tumors in first stage). "The cost of establishing the proton therapy centre is close to Rs 500 crore in India," he added. Leveraging high quality imaging and proton therapy offers the potential to increase confidence in the diagnosis and treatment of cancer, reduce short- and long-term side-effects and potentially enhance the quality of life of the patient before, during and after treatment. Advanced MRI, PET and CT imaging technologies will help physicians better target proton beam delivery to destroy cancer cells whilst avoiding healthy tissue. This agreement builds upon the collaboration between Philips India and IBA, which started in 2013, to build the Apollo Proton Therapy Center, the first proton therapy center in India. "We are privileged that Philips India is supporting us in bringing cutting edge proton beam therapy to India. We are certain that this initiative will be a significant step in improving the quality of cancer treatment in the country," said Mr Olivier Legrain, chief executive officer (CEO), IBA, adding, "With this collaboration, IBA further strengthens its world leading position in proton therapy and stays at the forefront of delivering the latest in innovative cancer therapy to the Asia region. Globally, IBA has now sold 33 proton therapy centers, more than all other providers combined." Proton therapy is an important addition to cancer treatment in India given that the incidence of cancer is 70-90 per 100,000 people with children comprising nearly 5 per cent of these patients. Proton therapy is considered to be one of the most advanced treatments available in the fight against cancer. With the precision that proton therapy offers, it is possible to target the tumor more effectively while limiting the side effects of the treatment. Protons deposit the majority of their energy within a precisely controlled zone, directly in the tumor while limiting the impact on healthy tissues surrounding the tumor. Proton therapy is particularly appropriate for the treatment of eye and brain cancers, tumors close to the brain stem and spinal cord as well as prostate, liver, lung cancers. Proton therapy is also extremely well-suited for the treatment of pediatric cancers. The exclusive Philips-IBA agreement for India follows the framework agreement that Philips and IBA signed in September of last year. The framework agreement comprises research and development, marketing and sales of imaging and therapy solutions in oncology. The collaboration also enables both organizations to mutually leverage technologies and solutions: IBA benefits from Philips diagnostic imaging products offered to oncology care centers, while Philips will leverage IBA proton therapy solutions within its offering for customers in select markets around the world. As part of the framework agreement, Philips and IBA have already signed multiple country-specific collaboration agreements, each optimized for the local market needs. ]]> <![CDATA[Presenting India as a 'Bio-manufacturing Hub': Are we ready?]]> https://biospectrumindia.com/features/95/6181/presenting-india-as-a-bio-manufacturing-hub-are-we-ready.html https://biospectrumindia.com/features/95/6181/presenting-india-as-a-bio-manufacturing-hub-are-we-ready.html Sat, 13 Jun 2015 08:43:00 +0530 Industry leaders believe that the negativity created by prevailing regulatory environment and unending controversies, have led to under performance of the biotech sector. However the renewed focus on producing quality Indian products has brought to fore a hidden opportunity to show its importance in the new context. To begin with, it is the time multinational companies working in India should stop maligning image of the country, mentioned Dr Kiran Mazumdar Shaw, chairman and managing director, Biocon during her talk at the BIRAC's Foundation day at Delhi. "They should stop India bashing as it won't help in any way" she said. Dr Shaw requested the prime minister's office to have more thrust on science and technology. She added further, "Manufacturing requires public private partnership to develop highest quality product at low cost. That can't be done unless there are interventions at highest level." Knocking opportunities: Do we fit into competitive space? With several biologics off the rack of patent shelves in the next five years, the combined sales potential of more than US$ 60 billion represents a massive opportunity for India to contribute through vaccines and biosimilars. To lap this up, there is a need to build a strong image globally, believes Prof Anurag S Rathore, Department of Chemical Engineering, Indian Institute of Technology (IIT), Delhi. "One or two incidents on quality are repeated globally, leading to negative perceptions," he says, "Need to do more to change this as a country. Action should be taken against the bad products. There are three aspects: technical, policy and brand management that require attention." Talking in particular about vaccine industry's role, Dr Suresh Jadhav, executive director, Serum Institute of India, drew a comparative scenario between developed countries and India. "Two third children across world getting Indian manufactured vaccines. While in US, there are Pfizer and Merck, the Europe has few manufacturers that include GSK and Bethovan are few others. Therefore, the role of 52 Indian vaccines manufacturers whose 23 products have been so far certified by WHO, obviously becomes stronger. Also, at times, GAVI used to procure pentavalent vaccine at $4 but now with manufacturers from developing countries in picture, the prices have come down to $1.5." Dr Jadhav wants the government to understand the issues not just politically but financially as well. He adds, "We admire government's political will but the allocations are not enough to implement vaccines in universal immunization programme." Raising an important issue, a top executive from Shantha Biotechnics, says, "It is very important to bring down the cost of vials as the product inside them is far lesser in cost then the vials itself. Packaging material cost woes have to be addressed to bring a sea change in affordability." Undoubtedly, the quality and affordability are two factors that can make or break the backbone of an industry. Infact, the quality is said to be the holy grail of manufacturing. Therefore, pointing towards importance of sustainability, Dr Amulya Panda, senior scientist, National Institute of Immunology (NII) reminds about the failure of antibiotic vaccine manufacturing in past and a need to study the causes. "The unemployment is a huge issue and how can biomanufacturing help to reduce that must be our goal. We need to build our own capacities and capabilities. Have to convince government that biotech products are not comparable with other general products." Mr Vinay Konaje, managing director, Navya Biologicals, feels that India has only fewer options than to jump into manufacturing bandwagon. "There is no doubt that in future, the biomanufacturing will have to cater to huge population and meet demands," he says. What is holding us back? The competency has a lot to do with the next stage. So has the industry as well as government got their priorities right for that? Infact, the question is whether the existing system being followed is indeed the right one? Therefore, as one of the right approaches, national and international partnerships are very important for reducing risks during product development and increased capabilities. The scientific tourism as rightly pointed out by an industry leader can be a great plus point for the country only when we ensure the world class facilities at much affordable cost. "Government has been both a challenge as well as a partner," says Mr Shrikumar Suryanarayan, founder, Sea6 Energy, who calls the existing regulatory laws as xenophobic. "Biodiversity law says you need to take permission from the government virtually. See a phenomenal shift in attitude for innovation that never existed earlier. Cutting across verticals, I envision an industry that has proactive regulations." The regulations instead of ensuring quality have become a bottleneck for innovation, feels Dr Shirshendu Mukherjee, senior strategic advisor-India, Wellcome Trust, adding, "There is a need for rejig at policy level. Advocacy has to be generated for implementing the innovations. Cutting across verticals, I envision an industry that has a proactive regulation." Given their defunct status, it is easier to work with NASA but not Indian public institutes, said a highly agitated industry expert. "Every FDA, be it Europe or US, has the right to protect their subjects. We use technology for creating customized products. End user perspectives need to be considered," he adds further. Ms Mukta Arora, director, Global External R&D, Eli Lilly India lays the thrust on predictable regulatory regime. Obsolete ideas must be replaced with new approach she says adding that algorithms or data on the disease is missing. Innovation has to be in sync with the policy framework." Making the right pitch for inter-ministerial interactions, Dr K Vijay Raghavan, secretary, DBT, feels that the communication is missing. "Need to chart out exact estimate of what our true expectations are! And efforts have to be driven collectively at higher levels." Agrees Dr T S Rao, senior advisor, DBT, who says that the great vaccine programmes we see today would have not been possible if there would have not been communication. "I am a strong supporter of Make in India but we have to know our exact requirement and the effort should be driven by collective effort of departments and ministries." Local ecosystem has to be leveraged The missing link between various components of a regional ecosystem, serves as a hindrance to overall growth of the sector. For example, as pointed out by an expert, despite hosting one of the largest bioindustrial company and largest vaccine firm, the city of Pune has yet not been able to leverage it for presenting itself as a potential hub. Mr Shomitro Ghosh, CEO, WISH Foundation (involved in promoting healthcare innovations), gives an interesting perspective based on experiences. He says, "The 80 percent of innovators are from South India whereas 70 percent of requirements are form North India. In such situation, language and other barriers are a great hindrance to effective implementation. Need is to have local innovators." On policies, he adds,"Despite a national policy, the actions at state level are missing. Private sector is forced to be a part of government schemes for the sake of it. There has to be a crosstalk before any big policy is devised and implemented." The lack of connect between existing ecosystems and the biotech enterprises can lead to hurdles in successful product development. The accessibility to the business and technical platforms is another factor that influences the biotech landscape. As per Ms Deeepanwita Chattopadhyay, chairman and CEO, IKP Knowledge Park, "Collaboration between academia and industry help in cost cutting, thus paving way for delivery of good technologies. Complimentary verticals are required for technology development." The research institutes have to work within confines of limited financial and work resources. Prof S Ramaswamy, CEO, Centre for Cellular and Molecular Platforms (C-CAMP) mentions, "We don't have enough disruptive technologies as the budget is just 100 fold whereas the biologists are 1000 fold." Sharing his experiences on do's and don'ts, Dr P M Murali, president, Association of Biotechnology Led Enterprises (ABLE), says, "Have done partnerships with the academia and learned that we have to be careful about biocluster environment. Keeping a University just as a supply chain model has to be done away with." For building the indigenous product manufacturing movement in the industry, we have to set our house in order. And that surely can't be achieved through one component working overtime while others still figuring out their exact role. There is need for seniors from industry to understand the needs of budding entrepreneurs and mentor them without a feeling of competition. Therefore, to understand the context in which we are working has to remain on top. Overcoming barriers: âˆ? Lack of infrastructure. âˆ? Unskilled workforce. âˆ? Not enough translational research. âˆ? Regulatory issues. âˆ? Missing local ecosystem Factors that could serve as catalysts : â‡“ Development of local regional hubs. â‡“ Pubic private partnerships. â‡“ Leveraging academic expertise. â‡“ Policies in sync with industry's needs. â‡“ Incentivizing technology entrepreneurs. (Note: The article is based on the panel discussions at BIRAC's Foundation Day and personal interactions.) ]]> <![CDATA[Sequoia pumps Rs 100 crore into La Renon Healthcare]]> https://biospectrumindia.com/news/95/3673/sequoia-pumps-rs-100-crore-into-la-renon-healthcare.html https://biospectrumindia.com/news/95/3673/sequoia-pumps-rs-100-crore-into-la-renon-healthcare.html Fri, 12 Jun 2015 13:00:18 +0530 Based in Ahmedabad, La Renon Healthcare, a pharma manufacturer and marketer of solutions for unmet medical needs, has raised Rs 100 crore from Sequoia Capital in its Series A funding. The company's founder Mr Pankaj Singh in a statement said that the money will be channeled for the company's R&D and further expansion into other new areas. ]]> <![CDATA[Jubilant's Spokane facility successfully concludes inspection status ]]> https://biospectrumindia.com/news/95/3657/jubilants-spokane-facility-successfully-concludes-inspection-status-.html https://biospectrumindia.com/news/95/3657/jubilants-spokane-facility-successfully-concludes-inspection-status-.html Fri, 12 Jun 2015 12:57:00 +0530 Jubilant Life Sciences Ltd, an integrated global Pharmaceuticals and Life Sciences Company, announced today that its subsidiary, Jubilant HollisterStier has been informed by the US Food and Drug Administration (USFDA) that its pharmaceutical sterile manufacturing facility in Spokane, Washington (USA) has been upgraded to the status of Voluntary Action Indicated (VAI). The Spokane site's latest Establishment Inspection Report (EIR) indicates the inspections in April 2014 and December 2014 have been successfully concluded. This upgradation by the USFDA from Official Action Indicated (OAI) to VAI is indicative of the cGMP status at the facility since receiving the warning letter in 2013. Commenting on the above development, Mr. Shyam S Bhartia, Chairman and Mr Hari S Bhartia, Co-Chairman & Managing Director, Jubilant Life Sciences said "Jubilant remains committed to continuous improvements to maintain compliance at all its pharmaceutical manufacturing facilities across the globe. We consider this development as another step towards building a reliable and sustainable pharmaceutical business". ]]> <![CDATA[NetMeds.com â€” Dadha Group's e-pharmacy portal goes online]]> https://biospectrumindia.com/news/95/7461/netmeds-com-dadha-groups-e-pharmacy-portal-goes-online.html https://biospectrumindia.com/news/95/7461/netmeds-com-dadha-groups-e-pharmacy-portal-goes-online.html Fri, 12 Jun 2015 12:37:33 +0530 The Dadha Group-owned NetMeds.com, the e-marketplace for pharma that offers delivery of pharmaceuticals across the country, announced the commencement of its operations on June 11, 2015. Billing itself as 'India Ki Pharmacy', the site offers an impressive selection of both prescription drugs and non-prescription products (OTC) drugs, supplying over 25,000 stock keeping units (SKUs) across India from its first warehousing hub in Chennai. The company intends to offer 24-hour delivery in Chennai and two to four day delivery in other cities of the country. NetMeds plans to expand its presence by setting up warehouses through tie-ups in 16 metro and non-metro cities in next 12-18 months period. The portal offers prescription medication users an opportunity to select their required medications from more than 260 drug categories for the Chronic Conditions, such as Diabetes, Hypertension and Cholesterol Control. Apart from branded drugs, portal will offer generic alternatives for every medicine ordered on the website. The Indian pharmacy market is estimated at Rs. 83,000 crore with drug consumed for chronic aliment such as diabetics, blood pressure, hyper tension, etc. accounting for over 40 per cent of the share. In addition to the prescription drug catalog, Netmeds offers a compliment of 8 Categories of over-the-counter (OTC) remedies for pain, category for diabetic support like monitors and test strips, personal care section and others. In the non-prescription category, there are currently a total of 3,000 SKU's including many of the brands like L oreal, Fogg and Axe. The current, and ever-expanding catalog of prescription tablets, capsules, ointments and compounds boasts 25000 SKU's, including both brands and generics. Products will be sourced from more than 185 Indian manufacturers, including a home page menu of the top 25, such as Sun, Ranbaxy, Cipla and Dr. Reddy. ]]> <![CDATA[CEO of Huntsman Cancer Institute joins J&J's Board of Directors]]> https://biospectrumindia.com/news/95/4169/ceo-of-huntsman-cancer-institute-joins-jjs-board-of-directors.html https://biospectrumindia.com/news/95/4169/ceo-of-huntsman-cancer-institute-joins-jjs-board-of-directors.html Fri, 12 Jun 2015 12:32:14 +0530 Johnson & Johnson (J&J) has announced that its Board of Directors has appointed Dr Mary Beckerle, chief executive officer and director of Huntsman Cancer Institute at the University of Utah, as a Director of J&J. Dr Beckerle will serve on the Board's Science, Technology and Sustainability Committee. Dr Beckerle has served as the CEO and Director of Huntsman Cancer Institute since 2006, and she was appointed in 2009 to an additional key health sciences leadership role as an associate vice-president for Cancer Affairs at the University of Utah. She joined the faculty of the University of Utah in 1986, and is a distinguished professor of biology and oncological sciences, holding the Ralph E and Willia T Main Presidential Professorship. "Dr Beckerle's expertise in scientific research and organizational management in the health care arena will be invaluable as a member of our Board of Directors," said Mr Alex Gorsky, chairman and CEO of J&J. He added, "Her commitment to the needs of patients is directly aligned with Our Credo and mission, and she is a welcome addition to the Johnson & Johnson Board." As an active participant in the national and international scientific affairs, Dr Beckerle has served on the NIH Advisory Committee to the Director and as the Chair of the American Cancer Society Council for Extramural Grants. She currently serves on the Scientific Review Board of the Howard Hughes Medical Institute and the Scientific Advisory Boards of the National Center for Biological Sciences at the Tata Institute of Fundamental Research in India and the Mechanobiology Institute in Singapore. Dr Beckerle is also currently on the Board of Directors of the American Association for Cancer Research, the Coalition for Life Sciences and the Huntsman Corporation. Dr Beckerle held a Guggenheim Fellowship at the Curie Institute in Paris, received the Utah Governor's Medal for Science and Technology in 2001, the Sword of Hope Award from the American Cancer Society in 2004 and is an elected Fellow of the American Academy of Arts and Sciences. ]]> <![CDATA[Baxter to demerge its biopharmaceuticals business]]> https://biospectrumindia.com/news/95/3472/baxter-to-demerge-its-biopharmaceuticals-business.html https://biospectrumindia.com/news/95/3472/baxter-to-demerge-its-biopharmaceuticals-business.html Fri, 12 Jun 2015 12:31:49 +0530 Baxter International has announced that its Board of Directors has approved the planned separation of its biopharmaceuticals business, which will be known as Baxalta Incorporated. The company has declared a special dividend distribution of 80.5 percent of the outstanding shares of Baxalta common stock. Baxter will retain a 19.5 percent ownership stake in Baxalta immediately following the distribution. For each share of Baxter common stock held of record as of the close of business on June 17, 2015, Baxter shareholders will receive one share of Baxalta common stock. Shareholders will receive cash in lieu of fractional shares. The special dividend is expected to be paid on July 1, 2015. The distribution of Baxalta common stock will complete the proposed separation and Baxalta expects to begin trading regular way as an independent company beginning July 1, 2015 on the New York Stock Exchange (NYSE) under the ticker symbol BXLT. Baxter expects "when-issued" trading for both Baxter and Baxalta to begin on the NYSE on June 15, 2015 under the symbol "BAX WI" for Baxter and "BXLT WI" for Baxalta. ''This announcement marks an important milestone towards the creation of two global independent healthcare companies that share a common heritage of saving and sustaining lives,'' said Robert L Parkinson, Jr., Baxter's chief executive officer. He added, ''The spin-off underscores Baxter's commitment to ensuring its long-term strategic priorities remain aligned with shareholders' best interests while creating enhanced value for patients, healthcare providers and other key stakeholders.'' The spin-off has been structured to qualify as a tax-free distribution to the US holders of Baxter's common stock for the US. federal income tax purposes. However, cash received in lieu of fractional shares may be taxable to such shareholders. Shareholders should consult their tax advisors with respect to the US federal, state, local and non-US tax consequences of the separation and distribution of Baxalta. No action is required by Baxter shareholders to receive shares of Baxalta common stock as part of this special dividend. Any holder of Baxter common stock who sells shares of Baxter common stock on or before the distribution date may be selling the entitlement to receive shares of Baxalta common stock. Following the separation, Baxter will have a broad global footprint built around fluid systems, renal therapies, parenteral nutrition, inhalation anesthetics and biosurgery products. It will be focused on developing new healthcare solutions in hospital, in-center and home based therapies. ]]> <![CDATA[Sandoz recalls its drug in the US]]> https://biospectrumindia.com/news/95/6481/sandoz-recalls-its-drug-in-the-us.html https://biospectrumindia.com/news/95/6481/sandoz-recalls-its-drug-in-the-us.html Fri, 12 Jun 2015 10:54:20 +0530 Sandoz Inc, the generic pharmaceuticals division of drug major Novartis is recalling 1,023,430 units of anti-allergic Cetirizine HCl chewable tablets in the US due to impurity concerns. According to information on the United States Food and Drug Administration (USFDA) site, the recall is for Cetirizine HCl chewable tablets of 10 mg, 6-tablets in one blister, in 12 (2 blisters) and 24 (4 blisters) tablet count configurations. The tablets were manufactured by the company's unit in Navi Mumbai. The firm-initiated Class III recall is due to "failed impurities/degradation specifications after an out of specification ( OOS) result was reported for impurity at the 21 month stability time point," the USFDA said in an Enforcement Report for the week of June 10, 2015. ]]> <![CDATA[Glaucoma treatment market value to grow moderately to $3 bn by 2023]]> https://biospectrumindia.com/features/95/4338/glaucoma-treatment-market-value-to-grow-moderately-to-3-bn-by-2023.html https://biospectrumindia.com/features/95/4338/glaucoma-treatment-market-value-to-grow-moderately-to-3-bn-by-2023.html Thu, 11 Jun 2015 14:25:49 +0530 The treatment market for glaucoma will rise in value from $2.4 billion in 2013 to approximately $3 billion by 2023 across the seven major markets (7MM) of the US, France, Germany, Italy, Spain, UK, and Japan, representing a moderate overall Compound Annual Growth Rate (CAGR) of 2.4 percent, says research and consulting firm GlobalData. The company's latest report states that growth will be driven by the arrival of innovative first-in-class drugs, such as Rhopressa/Roclatan, Vesneo, and Trabodenoson, and the introduction of additional fixed-dose combination (FDC) products, such as Tapcom/Taptiqom and Simbrinza, during the forecast period. According to Dr Catherine Daly, GlobalData's senior analyst covering Neurology and Ophthalmology, sales for glaucoma treatment will remain relatively flat until 2016, followed by a period of sustained growth due to the arrival of pipeline drugs. Dr Daly says: "The six products anticipated to enter the 7MM during the forecast period will collectively generate sales of $672 million by 2023, constituting a 22.2 percent share of the global market. "Aerie's Roclatan is forecast to achieve the highest sales among these drugs, and is expected to generate approximately $262 million in 2023. Significant uptake of Roclatan in the US, due to the drug's enviable position of becoming the first prostaglandin, analog-containing FDC product available in this large arena, will be the main overall market driver." US sales are expected to increase from $1.7 billion in 2013 to $2.2 billion by 2023 at a CAGR of 2.5 percent, with its overall market share rising slightly from 70.7 percent to 71.6 percent over the same period. Dr Daly explains: "This increase is mainly attributed to the expected introduction of several new products between 2013 and 2023, and the overall increase in glaucoma prevalence that is mostly due to an aging society in the US. "However, Allergan will lose patent protection for its FDC drug Combigan in 2022, allowing generic brimonidine + timolol FDC products to enter the arena. This will negatively impact the US market value and slow the overall growth rate in the last two years of the forecast period." ]]> <![CDATA[Mylan recalls its drug in the US]]> https://biospectrumindia.com/news/95/6175/mylan-recalls-its-drug-in-the-us.html https://biospectrumindia.com/news/95/6175/mylan-recalls-its-drug-in-the-us.html Thu, 11 Jun 2015 12:19:21 +0530 Mylan NV has announced that its US-based Mylan Institutional business is expanding its voluntary nationwide recall to the hospital/user level, of select lots of the following injectable products, due to the presence of visible foreign particulate matter observed during testing of retention samples. Gemcitabine for Injection, USP is an intravenously administered product indicated for the treatment of ovarian cancer, breast cancer, non-small cell lung cancer and pancreatic cancer. These lots were distributed in the US between January 8, 2014, and February 10, 2015, and were manufactured and packaged by Agila Onco Therapies Limited, a Mylan company. Lot 7801084 and 7801110 are packaged with a Pfizer Injectable label. Methotrexate Injection, USP 25 mg/mL can be administered intramuscularly, intravenously, intra-arterially, or intrathecally and is indicated for certain neoplastic diseases, severe psoriasis and adult rheumatoid arthritis. The lot was distributed in the US between December 8, 2014, and December 19, 2014, and was packaged by Agila Onco Therapies Limited, a Mylan company. Administration of a sterile injectable that has foreign particulates has the potential of severe health consequences. To date, Mylan has not received any reports of adverse events related to this recall. The company is notifying its distributors and customers by letter and is arranging for return of all recalled products. Distributors, retailers, hospitals, clinics, and physicians that have these products which are being recalled should stop use and return to the place of purchase. This recall is being conducted with the knowledge of the US Food and Drug Administration. ]]> <![CDATA[AstraZeneca India launches diabetes drug ]]> https://biospectrumindia.com/news/95/4273/astrazeneca-india-launches-diabetes-drug-.html https://biospectrumindia.com/news/95/4273/astrazeneca-india-launches-diabetes-drug-.html Thu, 11 Jun 2015 11:51:27 +0530 AstraZeneca Pharma India (AstraZeneca India), has announced the launch of FORXIGA(dapaglifozin), a breakthrough treatment for Type 2 diabetes mellitus. FORXIGA belongs to a new class of Type 2 diabetes mellitus medication, a highly selective inhibitor of sodium-glucose co-transporter 2 (SGLT2). It has an unique insulin independent mode of action that helps remove excess glucose from the body via urine which is associated with reductions in glycated haemoglobin (HbA1c), weight and systolic blood pressure. Globally, FORXIGA is the first medicine in the new SGLT2 inhibitor class to gain regulatory approval for the treatment of Type 2 diabetes mellitus. FORXIGA tablets are indicated as a once-daily oral medication to improve glycaemic control in adult patients with Type 2 diabetes mellitus. The drug is indicated to be used as an adjunct to diet and exercise in combination with other glucose-lowering medicinal products, including insulin, or as a monotherapy in metformin-intolerant patients. The drug is currently approved in more than 40 countries. Mr Sanjay Murdeshwar, MD, AstraZeneca India said, "FORXIGA represents a significant advancement in the treatment of Type 2 diabetes mellitus with global safety and efficacy data of 4 years. It is an important addition to our innovative anti-diabetic portfolio; strengthening our commitment to transform patient care in diabetes by offering an additional treatment option for over 63 million diabetic patients in India." Dr Bhavesh Kotak, vice-president, Medical and Regulatory Affairs, AstraZeneca India said, "Reaching treatment goals of diabetic patients continues to be a challenge in spite of multiple therapeutic options of oral and injectable anti diabetic agents. FORXIGA works by blocking reabsorption of glucose in the kidneys. Excess glucose gets excreted via urine helping patients achieve glycaemic control, a major treatment goal." ]]> <![CDATA[Glenmark receives ANDA approval for Calcipotriene Cream]]> https://biospectrumindia.com/news/95/6470/glenmark-receives-anda-approval-for-calcipotriene-cream.html https://biospectrumindia.com/news/95/6470/glenmark-receives-anda-approval-for-calcipotriene-cream.html Thu, 11 Jun 2015 11:50:53 +0530 Glenmark Pharmaceuticals has been granted final approval by the United States Food and Drug Administration (US FDA) for Calcipotriene Cream, 0.005 percent. The drug is the therapeutic equivalent of Dovonex Cream, 0.005 percent of Leo Pharma A/S. The company plans to commence shipping of Calcipotriene Cream, 0.005 percent immediately. According to IMS Health sales data for the 12 month period ending April 2015, the Dovonex market achieved annual sales of approximately $91.9 million. ]]> <![CDATA[Dr Swaminathan exhorts agri-scientists to find viable solutions]]> https://biospectrumindia.com/news/95/8005/dr-swaminathan-exhorts-agri-scientists-to-find-viable-solutions.html https://biospectrumindia.com/news/95/8005/dr-swaminathan-exhorts-agri-scientists-to-find-viable-solutions.html Thu, 11 Jun 2015 11:23:43 +0530 Known better as father of Indian green revolution, Professor M S Swaminathan, also the founder president of National Academy of Agricultural Sciences, India delivered a Special Silver Jubilee Lecture during the 25th Year celebration of the Academy at New Delhi. More than 300 Fellowship and full house listened to the doyen of Indian Agricultural Sciences of India who, as brilliantly as ever, took the agricultural scientists through a journey over the last six decades of adventurous foray into research to solve the agrarian problems in worsening ecological and environmental situations in India. Delving into the innovative and yet strategically applicable research priorities set up by the Agricultural Research Communities led ably by Indian Agricultural Research Institute in the early decades of the last century and the reconstituted Indian Council of Agricultural Research into which IARI and other national agri-research institutes were pooled together in direct working links with the upcoming Agricultural Universities in the different States of India. Professor Swaminathan was critical about the ecological dangers the production oriented agriculture as well as uncontrolled markets leaving farmers to face uncertainties almost all the time. The adventure therefore lay in developing technologies led by varieties with value addition and resource management options which enable the farmers to continue to keep the production levels up. He also exhorted the younger group to adopt the exceptionally practical scientific tools from biotechnology, nano-sciences, bio-resource conservation, etc., to quickly deliver with high predictable effects. Each of these options was explained with appropriate examples and case-studies. The audience gave Professor Swaminathan a standing ovation for the energising and technically highly informative lecture. The current President of the Society and Secretary, Department of Agricultural Research and Education and Director General of ICAR, along with several research leaders and past presidents was among the audience. ]]> <![CDATA[NAAS celebrates 25 years of scientific excellence]]> https://biospectrumindia.com/news/95/7389/naas-celebrates-25-years-of-scientific-excellence.html https://biospectrumindia.com/news/95/7389/naas-celebrates-25-years-of-scientific-excellence.html Thu, 11 Jun 2015 11:23:10 +0530 The celebration of the first Academy of India dedicated to Agricultural Sciences founded by leaders like Dr M S Swaminathan in 1990, on having completed 25 years of effective service to academia and research systems of India was spread over four days. The first day dedicated to the future scientists of the country, the post-graduate research students of National Agricultural Research And Education System. The students from 31 different Universities participated debating the issue of future of agriculture in India targeting 2040 as the year. In addition, a national essay competition was organized to coincide with the elocution on the topic of Agriculture as a profession. Both items gave a great hope as the almost all the young minds gave positive ideas and believed that India will soon be a global trade leader in agriculture and farmer the lead businessman of the country. The subsequent days were aimed towards seeking the impressions nurtured by the Associate Fellowship who are going to be around for at least next two decades, with reference to their own disciplines. Representing brighter side of the coin which invariably tended to have a darker uncertain side, the young group was enthusiastic in taking the science to its logical and applied products for better the agricultural situation despite the expected climate change impacts. Apart from the business session of the Annual General Body meetings, the Academy also summarised the recommendations from nation-wide Silver-Jubilee symposia held in different places in the country filtering information and recommendations which were discussed by an eminent panel. The highlights of the celebration were Special Silver Jubilee lectures delivered by the founder president of NAAS, Professor M S Swaminathan; director general, ICRISAT, Dr D Bergvinson and Director of University of Western Australia Institute of Agriculture, Professor KadambotSiddique. Professor Swaminathan gave a brilliantly painted a motivating picture of the adventurous side of Indian agricultural scientists who delivered technologies to farmers despite constraints and uncertainties. The final day was marked by an exceptionally well organised and inspiring Foundation Day lecture on June 5, 2015 by Professor Y K Alagh on the structure of Indian agriculture wherein with the policy supports the possibility of achieving the 4 percent growth rate was put forward. More than 250 Fellows participated on all the days which also saw recognition of three farmers and an agri-industrialist who have made India proud to face up to international challenges despite all the uncertainties accentuated by climate change. ]]> <![CDATA[Maharashtra withdraws permission to GM crop trials, ABLE-AG protests]]> https://biospectrumindia.com/news/95/6876/maharashtra-withdraws-permission-to-gm-crop-trials-able-ag-protests.html https://biospectrumindia.com/news/95/6876/maharashtra-withdraws-permission-to-gm-crop-trials-able-ag-protests.html Wed, 10 Jun 2015 17:19:12 +0530 After Maharashtra government's much appreciated move earlier this year, the confined field trials for 18 genetically modified events including rice, brinjal, cotton and chickpea have been put on hold for now by the state. In a letter to the concerned companies, the state has asked them to stop the field trials until further notice. Terming the decision of the state government as unfortunate, Dr Ram Kaundinya, chairman, Association of Biotechnology Led Enterprises-Agriculture Group (ABLE-AG) turned to Twitter to express his dismay. "Withdrawing permission for GM field trials by Maharashtra Government based on objections by some organizations is unfortunate & unscientific," he tweeted. It is important to note that the seed sowing season is approaching fast and delay to allow field trials could linger on in case of indecisiveness on the issue. The decision apparently has been taken after a meeting of members of civil society and few non-governmental organizations met the chief minister of the state, Mr Devinder Fadnavis. The letter issued to companies mentioned that the government has decided to put forth all the objections before the committee constituted under the chairmanship of Dr Anil Kakodkar. "All the objections raised will be reviewed and scrutinised and report submitted to the government. Till that time confined research field trials should not be started, it said. The decision on allowing of trials again is expected to be taken after the proposed meeting between Mr Kakodkar and activists is over. No date has been communicated yet on the said meeting. Given the fact that the state government is walking a tightrope over its no objection certificate to GM crops, the issue doesn't seem to be getting over any sooner. ]]> <![CDATA[Bayer to divest Diabetes Care business to Panasonic Healthcare for EUR 1,022 mn ]]> https://biospectrumindia.com/news/95/6378/bayer-to-divest-diabetes-care-business-to-panasonic-healthcare-for-eur-1022-mn-.html https://biospectrumindia.com/news/95/6378/bayer-to-divest-diabetes-care-business-to-panasonic-healthcare-for-eur-1022-mn-.html Wed, 10 Jun 2015 16:17:00 +0530 Bayer AG has entered into a definitive agreement to sell its Diabetes Care business to Panasonic Healthcare Holdings Co., Ltd., a company which is backed by funds sponsored by leading global investment firm KKR and the Panasonic Corporation. The total consideration for the transaction is EUR 1,022 million (JPY 138 billion). The sale will include the leading Contour portfolio of blood glucose monitoring meters and strips, as well as other products such as Breeze2, Elite and Microlet lancing devices. Closing of the transaction is subject to customary conditions, including relevant antitrust clearance, and is expected to occur in the first quarter of 2016. "We are confident that the sale of our Diabetes Care business to our long-standing partner Panasonic Healthcare, with the strong backing of KKR, will support the long-term sustainability of this portfolio," said Werner Baumann, member of the Board of Management of Bayer AG and CEO of Bayer HealthCare. Bayer's Diabetes Care business is a leading player in blood glucose monitoring systems, lancing devices and diabetes management software. The business accounted for EUR 909 million in sales in 2014, with Contour being the principal product portfolio. The Contour portfolio includes Contour Next, Contour Plus, Contour and Contour TS and is designed to meet the needs of all patients regardless of type of diabetes, stage of disease, or testing frequency. Other products include Breeze2, Brio, Entrust, Elite and Microlet lancing devices. "For more than 20 years, our companies have shared complementary goals. We anticipate that this partnership will take our two great businesses to new heights, and we wholly welcome the BDC team as full partners to Panasonic Healthcare," said Kenji Yamane, President of Panasonic Healthcare and Panasonic Healthcare Holdings Co., Ltd. ]]> <![CDATA[Abbott introduces 'LiverHealth' ]]> https://biospectrumindia.com/news/95/6236/abbott-introduces-liverhealth-.html https://biospectrumindia.com/news/95/6236/abbott-introduces-liverhealth-.html Wed, 10 Jun 2015 13:15:23 +0530 According to the company, under the initiative, people in states with high prevalence of Hepatitis C infection like Punjab, Haryana, NCR region and North East can get their liver health checked for free through a non-invasive liver imaging technology. "We believe that this 'LiverHealth' initiative will help people seek timely diagnosis of their liver health and treatment if needed. We plan to reach out to about 1.5 lakh people in 2015 through this initiative," said Mr an A Khan India MD said: The company has also launched the generic version of sofosbuvir, a novel, once-daily oral treatment for people with Hepatitis C infection, in the country. â€ƒ ]]> <![CDATA[AIIMS to set up a National Cardiovascular Center]]> https://biospectrumindia.com/news/95/6255/aiims-to-set-up-a-national-cardiovascular-center.html https://biospectrumindia.com/news/95/6255/aiims-to-set-up-a-national-cardiovascular-center.html Wed, 10 Jun 2015 13:15:06 +0530 AIIMS has proposed setting up of a National Cardiovascular center at its Jhajjar (Haryana) campus. It will be set up in collaboration with the Haryana government to address the paucity of specialists. "There is a paucity of specialists to treat cardiovascular diseases which has become an epidemic and is a leading cause of death apart from cancer and trauma in the country. Also there is a need of research in this sector. So AIIMS has proposed setting up this center," said Dr Neerja Bhatla, chairperson of media and protocol cell, AIIMS. He added, "The proposal was already put up before the Union Health Ministry which is quite positive about it. The cost of the project is estimated to be about Rs 3,100 crore." The proposal was put up by AIIMS Director Dr MC Mishra before Haryana chief minister Mr Manohar Lal Khattar during his visit to AIIMS. They also reviewed the setting up of National Cancer Institute at the Jhajjar campus. It is a collaborative project between AIIMS and the US National Cancer Institute. ]]> <![CDATA[Chronicling 365 days of Modi govt: Major highlights ]]> https://biospectrumindia.com/features/95/6017/chronicling-365-days-of-modi-govt-major-highlights-.html https://biospectrumindia.com/features/95/6017/chronicling-365-days-of-modi-govt-major-highlights-.html Wed, 10 Jun 2015 11:13:35 +0530 The National Democratic Alliance government led by the Prime Minister, Mr Narendra Modi completed one year on May 26, 2015. A year before on the same day, there was euphoria over new governance and progress that could possibly usher in India as a result of a majority stable government after a long time. Having been underestimated for long, the biotech sector was no different with the industry leaders and associations expressing optimism on change of fortunes. A galore of demands too was spoken of. So, have even few of these met or the challenges remain the same? This is a question which may get answered while we take a look at the few decisions taken by the government. Even though the review of policies so far have not been on the massive, most agree that the style of governance has witnessed a sea change. Launch of new programmes such as 'Make in India' and Swach Bharat' has exhibited the government's will to bring in change. These have found good connect with the industry leaders who have lauded such initiatives. For the health sector, the highlight of the year was certainly the release of the draft National Health Policy that recognised the relevance of medical technologies for a robust healthcare delivery system. The 'Make in India' campaign runs on science and technology, research and development, new processes, precision technology, innovation and skill and has tremendous potential to showcase talent of Indians working in life science domain and beyond. As per Dr Manu Jaggi, chief scientific officer, Dabur Research Foundation, "Modi government has taken some proactive steps in last one year, which has had a positive impact on the pharma industry. Allowing up to 100 percent FDI in medical devices in the pharmaceutical sector is a positive move. This is likely to attract more investments and boost the domestic manufacturing. Provision of essential medicines at lower rates is also a welcome step from which many will benefit. In the last one year, more than 300 life saving medicines which are used to treat life threatening diseases have been brought under drug price control by the Modi government." Dr Kiran Mazumdar Shaw, chairperson, Biocon feels that national interest is foremost. In one of her tweets, she mentioned, "Partisan politics must stop and focus should be on important national needs. GST is an urgent need of the hour." "Science and technology is of strategic importance to India's future leadership. India needs to step up its investment in research and translational innovation. We must identify key areas in which to build world-class scientific and technological excellence, for example, genomics, nanoscience, analytics, synthetic biology, information technology, space technology etc.," wrote Dr Shaw in Forbes India magazine. She has also asked the Modi government to look at incentivising innovation and IP creation is important for India's future growth prospects. "Enabling entrepreneurs to propel ideas into sustainable businesses will add value to our economy in the long run. The government should give R&D a boost by providing a 10-year tax holiday on products developed indigenously, provide tax breaks for venture funding, and allow zero duty on R&D equipment." Soon after the new government took over, the process of charting out a new regulatory pathway for vaccines was started by the Central Drugs Standard Control Organization (CDSCO) which constituted three core working groups from within the industry each for strategy, technical operations and technical post approval each with its designated chairman and member secretary who will take the things forward in a time bound manner. The new initiative is an outcome of the interaction between the vaccine manufacturers and importers in the country with the Drug Controller General of India (DCGI) on January 15, 2015 at the FDA Bhawan, in New Delhi. The dialogue between regulator and industry on various issues, challenges, opportunities in respect of manufacturing of priority vaccines including import of vaccines and regulatory pathways i.e to promote a legal, regulatory and administrative framework for the safety of vaccines at national and international levels. With a great potential to emerge as country's key industrial contributor, the vaccine businesses has not been fully able to evolve due to regulatory hiccups. Mr R K Suri, chief executive-biologicals, Panacea Biotec, mentioned, "It was indeed a new chapter on the anvil in the Indian regulatory space where the regulatory team under the able leadership of the DCGI, Dr GN Singh was clearly eager to translate the vision of our prime minister, Mr Narendra Modi to take India on the leadership level in the Vaccine map of the world in next 5-6 years." Report card oozes optimism: Healthcare âˆ? National Health Policy-2015The Ministry has formulated the Draft National Health Policy, 2015 and placed it in public domain on 30th December, 2014 for wide stakeholder consultation. The feedback received from the stakeholders is presently being analysed. The aim of the National Health Policy 2015 is to inform, clarify, strengthen and prioritize the role of the Government in shaping health systems in the country. This covers investment in the health sector, organization and financing of healthcare services, prevention of diseases and promotion of good health through cross sectoral action, access to technologies, developing human resources, encouraging medical pluralism, building the knowledge base required for better health, financial protection strategies and regulation and legislation for health. âˆ? Mission IndradhanushThe Ministry of Health & Family Welfare has launched "Mission Indradhanush", depicting seven colours of the rainbow, to fully immunise more than 89 lakh children who are either unvaccinated or partially vaccinated; those that have not been covered during the rounds of routine immunisation for various reasons. They will be fully immunised against seven life-threatening but vaccine preventable diseases which include diphtheria, whooping cough, tetanus, polio, tuberculosis, measles and hepatitis-B. In addition, vaccination against Japanese Encephalitis and Haemophilus influenza type B will be provided in selected districts/states of the country. Pregnant women will also be immunised against tetanus. The first round of the first phase started from 7 April 2015-World health Day- in 201 high focus districts in 28 states and carried for more than a week. This will be followed by three rounds of more than a week in the months of April, May June and July 2015, starting from 7th of each month. The 201 high focus districts account for nearly 50% of all unvaccinated or partially vaccinated children in the country. Of these, 82 districts are in just four states of UP, Bihar, Madhya Pradesh and Rajasthan and account for nearly 25% of all unvaccinated or partially vaccinated children of the country. 4.7 lakh children have so far been fully immunised. The children immunized under Mission Indradhanush are in addition to the children who are immunized under the Universal Immunisation Programme. Total of 297 districts will be targeted in the second phase to commence from September 2015. âˆ? India Newborn Action Plan (INAP)India loses about 7.5 lakh newborns ( < 28 days) every year primarily due to prematurity, sepsis and asphyxia. The India Newborn Action Plan (INAP) was launched in September 2014 to end all preventable newborn deaths and still births to a single-digit by 2030. The present neonatal mortality rate is 28 per thousand live births. âˆ? National Deworming DayAccording to WHO estimates, 24.1 crore children in the age group 1-14 year (68 percent of the total cohort) are at risk of parasitic intestinal worm infections that impair physical growth and cognitive development. The ministry observed the first National Deworming Day on 10 February 2015, followed with mop-up activities till 14 February 2015. It was implemented in 277 districts covering 11 States/UTs across 4.7 lakh schools and 3.67 anganwadi centers. âˆ? Maternal and Neonatal Tetanus Eliminated (MNTE) from the countryTotal of 32 States/UTs have been validated for Maternal and Neonatal Tetanus Elimination (MNTE) and the formal communication from WHO has been received. For the remaining four states of Nagaland, Meghalaya, Dadra & Nagar Haveli, and Jammu & Kashmir, field visits have been conducted by the joint team of WHO and UNICEF and the parameters for MNTE validation were found to be satisfactory. However, the formal communication from WHO is expected in two months. âˆ? Decision to introduce new vaccinesIn a bid to protect the children from more vaccine preventable diseases, new vaccines are proposed to be introduced as part of India's Universal Immunisation Programme (UIP). The Injectable Polio Vaccine will be introduced in October 2015. This will benefit 2.7 crore children every year. 20 high burden districts have been identified in Assam, Uttar Pradesh and West Bengal for adult JE vaccination in the age-group of 15-65 years. Rotavirus vaccine implemented to full scale would save approximately 1 lakh lives every year. Measles Rubella vaccine eliminates measles and its campaign will be carried out after appropriate planning and will cover 45 crore children. âˆ? Kala-Azar Elimination by 2015Action Plan for elimination of Kala Azar by 2015 launched in UP, Bihar, West Bengal and Jharkhand. This will benefit approximately 116.57 million population in the four states. The Action Plan includes active search, new drug regimen, coordinated Indoor Residual Spray (IRS) etc. First round of Indoor Residual Spray with DDT insecticide started in 33 districts of Bihar, 4 of Jharkhand and 11 in West Bengal. In addition, new non-invasive diagnostic kit has also been launched. âˆ? Drug resistant survey for 13 TB drugs launchedThe Health Ministry launched the biggest ever drug resistant survey in the world for 13 TB drugs in September 2014. The results are expected in a year's time. The nationwide drug resistance survey (DRS) will provide the Revised National TB Control Programme (RNTCP) with a better estimate on the burden of Multi-Drug Resistant Tuberculosis in the community. As part of the survey, the samples will be subjected to susceptibility testing for 13 anti-TB drugs (5 first line drugs and 8 second line drugs).In addition, under the Revised National TB Control Programme there has been rapid expansion of diagnostic facilities including highly sensitive molecular test at 119 facilities across various states for diagnosis of Multi-Drug Resistance TB and TB among HIV and pediatric patients. The baseline second line Drug Susceptibility Testing has been initiated in six states- Gujarat, Tamil Nadu, Kerala, Maharashtra, Karnataka and New Delhi. âˆ? National AIDS Control Programme66 new targeted interventions have been established taking the total to 1,818 that provide HIV prevention services to female sex workers, injecting drug users, migrants, truckers, etc. Computerized Inventory Management System launched to strengthen the supply chain management system of Anti-Retroviral Drugs, enhance efficient use of the drugs and minimize wastages across the country. âˆ? Six new AIIMSWork has been expedited on the 6 new institutes equivalent to All India Institute of Medical Sciences (AIIMS) at Raipur, Bhopal, Patna, Bhubaneshwar, Rishikesh and Jodhpur. During the last one year, the hospital work has begun and all the 6 new AIIMS are providing high-end clinical care besides the MBBS teaching activities. In addition, 9 new AIIMS one each at Andhra Pradesh, Maharashtra, West Bengal, Uttar Pradesh, Jammu & Kashmir, Punjab, Tamil Nadu, Himachal Pradesh and Assam are proposed to be set up. âˆ? Women health "Women's health, hygiene & nutrition" is the current focus under DBT's women's societal upliftment programme of DBT. The department has supported major programme on cervical cancer screening, genetic disorder & counseling, pregnancy-related complications, breast cancer screening & post-operative care. A project for awareness, counseling, screening & education to prevent genetic and congenital disorder has been implemented in West Bengal and a web based portal (www.genomegyan.com) on genetics has been developed to popularize it as a subject among medical students and physicians. Vaccines and diagnostics are under key focus in Modi government. Rotavirus vaccine launched The first indigenously developed and manufactured Rotavirus vaccine 'Rotavac.' from an Indian strain 116E was launched by the PM Modi on March 9, 2015. The indigenously developed vaccine will boost efforts to combat infant mortality due to diarrhoea. ROTAVAC developed in collaboration with Bharat Biotech under the Public-Private Partnership mode is efficacious in preventing severe rotavirus diarrhoea in low-resource settings in India. The NTAGI of M/o Health & FW has approved introduction of the vaccine in EPI in a pilot mode.Celiac Disease Diagnostics kit was commercially launched by Dr Jitendra Singh, the then Minister for Science and Technology, Government of India, at an event held in the ICGEB, New Delhi, on October 28, 2014. These kits have been developed through a collaborative, multi-institutional, inter-disciplinary approach funded by the Department of Biotechnology, Ministry of Science & Technology, Government of India. Agriculture: In order to implement the long pending demand of technology driven agriculture, the concerned ministry has launched 'Mera Gaon, Mera Gaurav' scheme involving agricultural experts of agricultural universities and ICAR institutes for effective and deeper reach of scientific farming to the villages. A group of experts will be associated with one particular village to create awareness and adoption of new technologies including farm investment, loans, availability of inputs and marketing. All the scientists from ICAR and agricultural universities will participate in this initiative. Indian Institute of Agricultural Biotechnology is being established at Ranchi (Jharkhand). Also, National Research Centre on Integrated Farming System is to be established at Motihari, Bihar. A new Central Agricultural University has been planned at Barapani, Meghalaya and Post Graduate Institute of Horticulture is to be established in Amritsar. IARI has initiated its outreach programme to further expand the PG education by offering courses in Horticulture and Agricultural Engineering in collaboration with ICAR-Indian Institute of Horticultural Research, Bengaluru and ICAR-Central Institute of Agricultural Engineering, Bhopal respectively. Agriculture and Technology Foresight Centre (ATFC) is to be established to foresee the coming changes in agricultural sector and plan accordingly. Education: Hike in Research FellowshipsThe NDA Government has fulfilled the much awaited demand of research scholars by revising the fellowships for various categories such as Junior Research Fellows, Senior Research Fellows and Research Associates. Across the board hike in fellowship amount is at least 50 percent more than what was existing. The hike was made effective from October 01, 2014. Junior Research fellowship was hiked from Rs 16,000 to Rs 25,000. Senior Research Fellowship was hiked from Rs 18,000 to Rs 28,000. Research Associateship was hiked from Rs 22,000, Rs 23,000 and Rs 24000 to Rs.36,000, Rs38,000 and Rs 40,000 respectively.Knowledge Involvement in Research Advancement through Nurturing (KIRAN) programmme was launched in the year 2014 to bring gender parity in science through nurturing the research career of women scientists. The programme is aimed at providing opportunities to women scientists who had a break in their career primarily due to family responsibilities. The programme includes women-exclusive schemes and encourages them to foster their career by undertaking research not only in science & engineering but also for societal benefit besides making a career through entrepreneurship. Technical Research CentresFinance Minister during his budget speech 2014-15 had announced setting-up of five Technical Research Centres (TRCs) in the existing autonomous institutions of the Department of Science & Technology. A detailed road-map has been prepared by the Department for setting-up of these centres. Necessary approvals are being obtained for these centres. TRCs are expected to speed-up the technology transfer and commercialization process of the research work being carried out by these autonomous institutions. North East remains a priority areaThe twining programme of DBT has supported nearly 400 R&D projects, leading to more than 200 papers published in peer reviewed journals, and more than 450 young scientists of NER trained in advamced biotechnology. Every year approximately 70-80 projects under this flagship programme are being supported to NER. Also, the setting up of "DBT-NER Centre for Advanced Animal Diagnostics and Services on Animal Health and Diseases (ADSAHD) was announced on February 17, 2015. With a view to recognize promising mid-career scientists in NER, a programme of awarding Unit of Excellence grant to them has been initiated so as to enable them to pursue their innovative research in frontier areas of biotechnology. So far, 12 Units of Excellence have been established during the year. Enhanced Innovation Ecosystem:Under the DBT, for a well-defined Innovation Ecosystem for product development - a Public Sector undertaking, Biotechnology Industry Research Assistance Council (BIRAC) has been set-up, supporting nearly 300 companies and 100 young entrepreneurs for innovation, research and product development. Further, the Biotechnology Translational research and industry academia partnership has promoted through 3 Biotech clusters, 8 Biotech Parks and 13 Bioincubators. Also, 16 Centers of Excellences have been created as a flexible model of long-term support for highly innovative, basic and translational research to create high quality state-of-the-art facilities for R&D.Biotechnology Industry Research Assistance Council Ace Fund (BIRAC Ace Fund) which is an equity fund for accelerating entrepreneurs was announced by science and technology minister, Harsh Vardhan during BIRAC Foundation Day event in Delhi recently. Clinical research The clinical research which was in shambles a year before is also slowly catching up. "Over the last few months, several steps have been taken by Indian regulators to bring clinical research in India back on track. We now need to restore confidence among all the stakeholders that robust and streamlined guidelines and systems are in place in the country for conducting clinical research," mentioned Ms Suneela Thatte, president, Indian Society for Clinical Research (ISCR) adding "Thousands of patients are desperately waiting for new therapies and drugs to enter the market, and we, as clinical research professionals, have an enormous responsibility to fulfill this need. We are fully committed to working with everyone across the clinical research spectrum to create an enabling environment which encourages scientific and ethical clinical research so that patients can have better and quicker access to new treatments." According to Dr Geeta Shroff, founder & medical director, Nutech Mediworld & India's leading stem cell expert. "During his first term in office, Modi has shown interest in stem cell research as it evident from his visit to various institutes across the country and abroad to access progress being made in stem cell research and genetics. He has reiterated the need for supporting "Indian discovery science" in order to boost national economy. Given the focus on creation of research and development in his budget, the Modi government has taken the first step to ensure that the healthcare sector gets back its confidence to grow and help in nation building." Indeed there needs to be separate policies for stem cells as they are not drugs hence should not be treated as such. It is also important that opinion of stem cell experts (those that have published and patented stem cell related work) be taken while drafting policies and not to be limited to governmental organizations. Dr Manu Jaggi draws attention to few other priority issues needed to be addressed, He explains, "Despite some of the drugs being banned internationally, a large number of drug combinations are widely sold in India without the necessary regulatory approvals,. We need to align our policy on this with other western countries. There is lack of transparency regarding government's strategy on the IPR. Despite India being TRIPS-compliant, this is sending a false signal. Further, the government is yet to share the new IPR policy." ]]> <![CDATA[PM takes stock of health programs, asks health ministry to keep vigil on JE ]]> https://biospectrumindia.com/news/95/6021/pm-takes-stock-of-health-programs-asks-health-ministry-to-keep-vigil-on-je-.html https://biospectrumindia.com/news/95/6021/pm-takes-stock-of-health-programs-asks-health-ministry-to-keep-vigil-on-je-.html Wed, 10 Jun 2015 11:12:11 +0530 PM Modi has said that an evaluation should be made on the contribution of Swachh Bharat Abhiyaan, towards improvement of health indicators. He called for documentation and adaptation of best practices in the healthcare sector across the country, to enable their rapid scaling up for maximum benefit. The Prime Minister noted that huge strides were being made in Human Development Index and social parameters, in areas where the Total Fertility Rate (TFR) has fallen significantly. He said that these benefits of low TFR should be brought before the people across the country. Mr Narendra Modi asked the health ministry to keep an eye on acute health problems affecting specific parts of the country, such as Japanese Encephalitis in Eastern Uttar Pradesh and Bihar. He also said more attention was required on the healthcare initiatives for the urban poor. Minister for Health and Family Welfare, Mr JP Nadda, was present at the meeting. ]]> <![CDATA[Modi govt's 1st anniversary: Decisive action needed feels industry]]> https://biospectrumindia.com/features/95/6134/modi-govts-1st-anniversary-decisive-action-needed-feels-industry.html https://biospectrumindia.com/features/95/6134/modi-govts-1st-anniversary-decisive-action-needed-feels-industry.html Wed, 10 Jun 2015 11:10:29 +0530 Seen as a silver lining in the dark clouds, the government's recent decision to allow FDI into two major Indian pharma firms is being seen as step to push indigenous manufacturing. The Cabinet Committee on Economic Affairs (CCEA), chaired by the Prime Minister, Mr Narendra Modi, on April, 07 approved qualified institutional buyers to infuse fresh equity of upto 7 percent amounting to about Rs 2165 crore into Aurobindo Pharma engaged in manufacturing generic pharmaceuticals and active pharma ingredients. Besides that $1 billion Glenmark Pharmaceutical's foreign investment limit by FIIs has been approved from 35.07 percent to 49 percent. This will result in an inflow of about Rs 2,022 crore. Apart from manufacturing pharmaceuticals, the company is also engaged in Research and Development activities in drugs. Key associations praise govt's policies "The government has exceeded our expectations and has achieved more in the first year than any other government has achieved in their first year. The government's emphasis on lower tax rates and introduction of GST in coming year will greatly enhance competitiveness of the Indian industry," said Mr Sumit Mazumder, president, Confederation of Indian Industries (CII). As per Ms Jyotsna Suri, president, Federation of Indian Chambers of Commerce and Industry (FICCI), "We are highly encouraged by the series of actions and policy reforms taken by the government in the last one year. The government has been successful in improving the state of the economy and setting the foundation for long term higher growth and development. Several path-breaking measures have been announced, notably the introduction of social security net for all citizens, rationalisation of corporate tax rates and implementation of GST by April next year." "Having taken several initiatives to unclog infrastructure projects and improve ease of doing business, Prime Minister Narendra Modi's government is expected to give increased attention to the rural economy, although several of the financial inclusion programmes like the Jan Dhan Yojana would help the countryside," remarked Mr Rana Kapoor, president, The Associated Chambers of Commerce of India (ASSOCHAM). Demands yet to be met feel BioSuppliers: The biosuppliers were eagerly looking at some announcement for hassle free business and rebates over import taxes of research products. Besides that, the funding allocations to research institutes were also expected to go up. But there has been no progress so far on these. Echoing the common view, Dr Vishal G. Warke, director R&D, Cell Culture and Immunology, Himedia Laboratories mentioned, "We are still waiting for the Modi government to release the funds for most of the research institutions in India, as the lack of funds and grants from the central government has adversely impacted our sector. Scientists are unable to buy a lot of reagents and products as they are still waiting for the funds to be disbursed." However, Dr Warke like his other counterparts in industry hasn't lost hope yet. He optimistically adds further, "On the whole however, the mood is very encouraging and positive with the Modi government and we feel that things should improve dramatically in the next year, in the biotech sector." The focus on non-adversarial, corruption-free and predictable policy regime is the core strength of the present government. As per critics, the first year's rule can be given full marks only in foreign policy and economics but a lot remains to be done for health, agriculture, education and science. While the Swach Bharat Abhiyan and Make in India surely are being appreciated as unique programmes but it will take a longtime to witness a visible change on ground. "India's biotechnology industry is on the cusp of entering a new era as the government focuses its efforts in building a research ecosystem that would spur medical innovation. It will take some time and too early to speculate, remarked an expert. This sums up the overall mood. Despite unmet expectations, industry seems to be hopeful of increased momentum over resolving specific issues of more regulatory clarity, business friendly environment and taxes. While the beginning has been good, this government surely has a lot to do and achieve. Perhaps industry will have to hold their horses for some more time. Gaps visible in talk and action: âŒ‚ While government has launched huge flagship programs, the funding allocations for health schemes are meagre. âŒ‚ Make in India will only succeed if there is ease of research in the country. Research and development projects require enhanced budget allocations and clear regulatory environment. âŒ‚ No decision yet on Biotechnology Regulatory Authority of India (BRAI) Bill, allowing the free trials of genetically modified (GM) crops and amendments in Biodiversity Law. âŒ‚ The indigenous drugs manufacturing that is on government's radar too would require to undergo clinical trials. But the drop in number of trials due to fear of stringent rules has to be dealt with accordingly to encourage more investments in drug discovery. ]]> <![CDATA[Bioresource information available now on DBT's single window platform]]> https://biospectrumindia.com/news/95/7276/bioresource-information-available-now-on-dbts-single-window-platform.html https://biospectrumindia.com/news/95/7276/bioresource-information-available-now-on-dbts-single-window-platform.html Tue, 09 Jun 2015 13:44:36 +0530 The vast natural biodiversity present in various states of India is well known and equally debated is the need to conserve the bioresources through various means. Therefore, now several institutes in the country have been working to document the status of the different species. In order to bring them on a platform, the Department of Biotechnology (DBT) initiated a programme, Indian Bio-resource Information Network (IBIN) in collaboration with Indian Institute of Remote Sensing (IIRS) Indian Space Research Organisation (ISRO) and University of Agricultural Sciences (UAS), providing a single window gateway to access distributed bio-resource database available in the country. The network will offer spatial and non-spatial services like biodiversity characterisation and inventorisation on diverse domains of bio-resources and biodiversity. IBIN has developed a distributed national data infrastructure to serve relevant information on various issues of bio-resources of the country to a range of end users like scientists, wildlife conservationists in a distributed framework. Collaborative effort with Indian Space Research Organisation and University of Agricultural Sciences assembled data on 39,000 species of plants, animals, marine organisms and microbes. Species and spatial data services to be provided to end users. Will help bio-prospecting, marketing, protecting bio-piracy & bio-resource conservation India is a country known for its vast and diverse natural resources. With a strong commitment to preserve and utilize India's resources for public good DBT has made an effort to bring the knowledge about the resources that lie distributed in several institutions in the country on a single platform. There are two core data nodes of the IBIN portal - the Species data (.Jeeva Sampada) maintained at UAS, Bangalore and Spatial data (Jeeva Manchitra) maintained at IIRS (ISRO), Dehradun. A network of partners called Bio-resource Information Centres (BRICs) are being adopted who will serve India's bio-resource's data like plant, animal, marine, spatial distribution and microbial resources etc. from their respective institutes/centres located in different parts of the country. This network would be expanded and more such existing database would be connected to provide both spatial and non-spatial information. IBIN facilitates value addition to the diverse and distributed datasets by bringing them together on one platform. Apart from the identified BRICs, there is a provision to capture the information provided by the end users as well. As per DBT, the data will be categorised on the basis of the source from which it is obtained. Core data - database that has already been created by the existing major IBIN nodes Distributed data- the data that would be contributed by its major partners (BRICs) and, Captured data - the data contributed by the end users in the public domain. Curetted data - the information that is processed and filtered periodically. The data is filtered and evaluated periodically by a national team of curator from IBIN and uploaded on the portal. Raw data which is captured from the public sources but yet to be curetted. The IBIN portal also offers these datasets in multilingual form for the benefit of end users. Five bio-resource information centres have been identified. They are Institutes of Himalayan Bio-resource Technology, Palampur, Himachal Pradesh. Bio-informatics Centre, NEHU, Shillong, Foundation for Revitalizing Local health Traditions, Bangalore Department of Botany, University of Calcutta, Kolkata and Ashoka Trust for Research in Ecology and the Environment, Bangalore. The network which initiated in the year 2011 has already assembled information on 39,000 species of plants, animals, marine organisms and microbes. IBIN's aim is to network and promote an open ended, co-evolutionary growth among all the loosely coupled digital databases related to biological resources of the country and to add value to the databases by integration and sharing. It is designed to serve relevant information on bio-resources of the country to the professionals involved in bio-prospecting, marketing, protecting bio-piracy and the conservation of bio-resources. ]]> <![CDATA[Diabetes & pulmonary diseases pose increased threat to Indian population: Lancet Report]]> https://biospectrumindia.com/news/95/4057/diabetes-pulmonary-diseases-pose-increased-threat-to-indian-population-lancet-report.html https://biospectrumindia.com/news/95/4057/diabetes-pulmonary-diseases-pose-increased-threat-to-indian-population-lancet-report.html Tue, 09 Jun 2015 13:44:06 +0530 People across India are living longer but spending more time in ill health as rates of nonfatal diseases and injuries - including major depressive disorder, iron-deficiency anemia, and low back pain - decline more slowly than death rates, according to a new analysis of 301 acute and chronic diseases and injuries in 188 countries. Years lived with disability (YLDs) quantifies the impact of health problems that impair mobility, hearing, or vision, or cause pain in some way. In 2013, migraines, chronic obstructive pulmonary disease (COPD), and hearing loss were among the 10 leading causes of YLDs in India. Other leading causes included neck pain, diabetes, and anxiety disorders. For both sexes combined, the leading causes of years lived with disability have remained largely the same during this time period, but they take an increased toll on health due to population growth and aging. For women in India, other musculoskeletal disorders - which include shoulder injuries and fractures from osteoporosis -and diabetes have replaced diarrheal diseases and uncorrected refractive error that causes vision problems as leading causes of years lived with disability. Between 1990 and 2013, YLDs from diabetes increased by 109 percent, and YLDs from other musculoskeletal disorders increased by 110 percent. Iron-deficiency anemia YLDs decreased by 12 percent. Diabetes YLDs also increased for men in India between 1990 and 2013, climbing 136 percent. YLDs from COPD increased by 76 percent, and iron-deficiency anemia YLDs decreased by 32 percent. "Global, regional, and national incidence, prevalence, and years lived with disability for 301 acute and chronic diseases and injuries in188 countries, 1990-2013: a systematic analysis for the Global Burden of Disease Study 2013" is the first study to examine the extent, pattern, and trends of nonfatal health loss across countries. Published in The Lancet on June 8, the study was conducted by an international consortium of researchers working on the Global Burden of Disease project and led by the Institute for Health Metrics and Evaluation (IHME) at the University of Washington. "The health of Indians is increasingly threatened by depression, back pain, and migraines," said Dr Vivekanand Jha, executive director - George Institute for Global Health, India and study co-author. "At the same time, diseases like iron-deficiency anemia, chronic obstructive pulmonary disease, diabetes and chronic kidney disease are also costing Indians many years of healthy life. It is critical that we understand which diseases and injuries are causing disability so that we can effectively allocate resources." Between 1990 and 2013, YLDs increased globally from 537.6 million in 1990 to 764.8 million in 2013 for both sexes. Men and women around the world share the same leading causes of YLDs, with the exception of schizophrenia as a leading cause for men and other musculoskeletal disorders for women. Musculoskeletal disorders, mental and substance use disorders, neurological disorders, and chronic respiratory conditions were the main drivers of YLDs in 2013. The disease burdens of both low back pain and depression have increased more than 50 percent since 1990. Researchers found that as people aged they experienced a greater number of ailments resulting from nonfatal diseases and injuries. Many people also suffered from multiple conditions at the same time. The number of people who suffered from 10 or more ailments increased by 52 percent. And it's not just the elderly who are affected. Although the impact of YLDs increases with age, of the 2.3 billion people who suffered from more than five ailments, 81 percent of them were younger than 65 years old. A relatively small number of diseases have a massive impact, researchers found. Just two acute diseases - affecting people for less than three months - caused more than 20 billion new cases of disease globally in 2013: upper respiratory infections (18.8 billion) and diarrheal diseases (2.7 billion). And just eight causes of chronic diseases - affecting people for three months or longer - impacted more than 10 percent of the world's population. These included tension-type headaches and iron-deficiency anemia. In 2013, war and conflict was a leading cause of YLDs in several countries as well, including El Salvador, Guatemala, Lebanon, Peru, and Syria. In three countries - Cambodia, Nicaragua, and Rwanda - war was the top cause of years lived with disability. Other notable causes of YLDs in different regions included falls (Central Europe), asthma (a top-10 cause in many Latin American countries), and opioid dependence (a top-five cause in several Middle Eastern countries).Nonfatal conditions are not yet becoming the dominant source of disease burden in sub-Saharan Africa as they are in other parts of the world, but their impact has grown since 1990. "What ails you isn't necessarily what kills you," said IHME Director Dr. Christopher Murray. "As nonfatal illnesses and related ailments affect more people of all ages, countries mustlook closely at health policy and spending to target these conditions." Leading causes of YLDs in India for both sexes, 2013 1 Major depressive disorder2 Iron-deficiency anemia3 Low back pain4 Migraine5 Chronic obstructive pulmonary disease6 Age-related and other hearing loss7 Neck pain8 Diabetes mellitus9 Anxiety disorders10 Uncorrected refractive error Leading causes of YLDs in India for men, 2013 1 Low back pain2 Major depressive disorder3 Iron-deficiency anemia4 Chronic obstructive pulmonary disease5 Migraine6 Age-related and other hearing loss7 Diabetes mellitus8 Neck pain9 Falls10 Uncorrected refractive error Leading causes of YLDS in India for women, 2013 1 Iron-deficiency anemia2 Major depressive disorder3 Migraine4 Low back pain5 Chronic obstructive pulmonary disease6 Age-related and other hearing loss7 Anxiety disorders8 Neck pain9 Diabetes mellitus10 Other musculoskeletal disorders ]]> <![CDATA[Mylan launches GSK's generic asthma drug]]> https://biospectrumindia.com/news/95/4337/mylan-launches-gsks-generic-asthma-drug.html https://biospectrumindia.com/news/95/4337/mylan-launches-gsks-generic-asthma-drug.html Tue, 09 Jun 2015 11:41:35 +0530 Mylan NV has announced that it has launched the first bioequivalent alternative to GlaxoSmithKline's Seretide Evohaler (salmeterol xinafoate/fluticasone propionate) under the brand name Sirdupla in the UK. Sirdupla is a pressurized metered-dose inhaler (pMDI) and is indicated to help treat or prevent symptoms of asthma in adults 18 years of age and older. The product is being manufactured by 3M Drug Delivery Systems. Mr Rajiv Malik, president, Mylan said, "Mylan is excited to be the first company to offer adult asthma patients in the UK the generic version of Seretide Evohaler, delivering on our mission to increase access to high quality medicine. Sirdupla represents a significant advancement for the company that both strengthens our respiratory portfolio and pipeline and further demonstrates our ability to successfully execute on one of our key strategic growth drivers." "The launch of Mylan's Sirdupla broadens patient access to an important treatment option and offers a familiar pMDI device experience to UK asthma sufferers. Asthma is a widespread illness in the UK and we are committed to contributing to ease this burden to both patients and the NHS," said Mr Jacek Glinka, Mylan's Europe president. Sirdupla is a daily maintenance pressurized metered-dose inhaler that offers the same ease of use that patients expect from their asthma therapy. It is available in 125/25 mcg and 250/25 mcg with 120 doses. ]]> <![CDATA[Diabetes vaccine enters Phase II clinical trial]]> https://biospectrumindia.com/news/95/4649/diabetes-vaccine-enters-phase-ii-clinical-trial.html https://biospectrumindia.com/news/95/4649/diabetes-vaccine-enters-phase-ii-clinical-trial.html Tue, 09 Jun 2015 11:39:20 +0530 A Phase II clinical trial testing the ability of the generic vaccine bacillus Calmette-GuÃ©rin (BCG) to reverse advanced type 1 diabetes has received approval from the US Food and Drug Administration (US FDA). The approval of this trial, which will shortly begin enrolling qualified patients, was announced at the 75th Scientific Sessions of the American Diabetes Association (ADA) by Dr Denise Faustman, director of the Massachusetts General Hospital (MGH) Immunobiology Laboratory and principal investigator of the study. The five-year trial will investigate whether repeat BCG vaccination can clinically improve type 1 diabetes in adults between 18 and 60 years of age who have small but still detectable levels of insulin secretion from the pancreas. Dr Faustman's research team was the first group to document reversal of advanced type 1 diabetes in mice and subsequently completed a successful phase I human clinical trial of BCG vaccination. "We have learned a lot since the early studies in mice, not just about how BCG works but also about its potential therapeutic benefits, similar to what are being seen in trials against other autoimmune diseases. We are so grateful to all of the donors, large and small, who have made this trial possible especially the Iacocca Foundation, which has believed in us and has been a supporter since our early days. Our goal is to complete enrollment and also to raise the remaining funds needed for the trial by the end of this year," said Dr Faustman. A generic drug with over 90 years of clinical use and safety data, BCG is currently approved by the FDA for vaccination against tuberculosis and for the treatment of bladder cancer. The vaccine is known to elevate levels of the immune modulator tumor necrosis factor (TNF), which Dr Faustman's team previously showed can temporarily eliminate in both humans and mice the abnormal white blood cells responsible for autoimmune type 1 diabetes. Increased TNF levels also stimulated production of protective regulatory T cells. In the phase I clinical trial, which was published in the August 8, 2012, issue of PLOS Medicine, two injections of BCG spaced four weeks apart led to temporary elimination of diabetes-causing T cells and provided evidence of a small, transient return of insulin secretion. The phase II clinical study will include more frequent dosing over a longer time period to determine the potential of repeat BCG vaccination to ameliorate the autoimmune state and improve clinical parameters such as HbA1c, a marker of average blood sugar control. In the new trial, which will be double blinded and conducted at MGH, 150 adults with long-term type 1 diabetes will be randomized to receive two injections four weeks apart of either BCG or placebo and then a single injection annually for the next four years. Patients will be closely monitored over the five-year trial period. The primary outcome measure will be improved results on the HbA1c blood test, which have been shown to prevent complications. "In the phase I clinical trial we demonstrated a statistically significant response to BCG, but our goal in phase II is to create a lasting therapeutic response. We will be working again with people who have had type 1 diabetes for many years. This is not a prevention trial; instead, we are trying to create a regimen that will treat even advanced disease. In addition to our phase I trial, we took guidance from the BCG clinical trials that are underway globally for other autoimmune diseases such as multiple sclerosis," said Dr Faustman. ]]> <![CDATA[Stempeutics receives Japan process patent for Stempeucel ]]> https://biospectrumindia.com/news/95/7060/stempeutics-receives-japan-process-patent-for-stempeucel-.html https://biospectrumindia.com/news/95/7060/stempeutics-receives-japan-process-patent-for-stempeucel-.html Tue, 09 Jun 2015 11:01:47 +0530 Stempeutics Research, a group company of Manipal Education and Medical Group and a Joint Venture with Cipla Group, has announced that it has been granted process patent from the Japan Patent Office (application no 2012-540529) for its novel stem-cell based drug Stempeucel. The novelty covers the method of preparing master cell banks, working cell banks and the final therapeutic product "Stempeucel" based on the novel pooling technology. Stempeucel will initially be used for the treatment of CLI, a breakthrough treatment option which directly addresses the root cause of the disease, unlike other drugs which typically treat the symptoms and not the disease itself. Stempeucel is derived from allogeneic pooled mesenchymal stromal cells extracted from the bone marrow of healthy, adult voluntary donors. The company proprietary pooling approach allows an efficient manufacturing process with minimum wastage of resources in order to provide the product at an affordable cost to patients. This approach also allows more than one million patient doses from a single set of master cell banks, which is unique in regenerative medicine. The proprietary technology allows Stempeucel to extend the therapeutic potential of the drug across multiple disease categories. Mr BN Manohar, CEO of Stempeutics said, "The new patent strengthens our position in Japan, which have created an accelerated development path for stem cell therapies. The new regenerative medicine law implemented in Japan allows conditional approval of stem cell products thereby enabling more rapid entry into the Japanese market. We are actively evaluating the potential for accelerated development of Stempeucel product for Critical Limb Ischemia and Osteoarthritis indications in Japan with strategic collaborations." "Japan is showing great leadership in innovating a regulatory framework for regenerative medicine thereby addressing major unmet medical needs faster. We would like to leverage this new framework for rapid development of our Stempeucel product for the benefit of patients along with a potential partner," said Mr Chandru Chawla, head, Cipla New Ventures. ]]> <![CDATA[Diverse asthma treatment pipeline presents major investment opportunity]]> https://biospectrumindia.com/features/95/3856/diverse-asthma-treatment-pipeline-presents-major-investment-opportunity.html https://biospectrumindia.com/features/95/3856/diverse-asthma-treatment-pipeline-presents-major-investment-opportunity.html Mon, 08 Jun 2015 17:04:40 +0530 The active and diverse treatment pipeline for asthma boasts a striking level of innovation, with many first-in-class products representing significant investment opportunities, says business intelligence provider GBI Research. The company's latest report states that while asthma therapy development is dominated by small molecule compounds, with 156 products representing 67 percentage of the pipeline, the R&D landscape has moved towards biologics on an unprecedented scale. There are now 60 biologics in the pipeline, representing a 26 percent share. Mr Yasser Mushtaq, senior analyst, GBI Research, says: There is a high degree of innovation across the entire asthma therapeutics pipeline. This includes phase III, consisting of multiple first-in-class drugs, many of which are biologics. "This active development is reflected in the current asthma deals landscape. Between 2006 and 2015, 65 deals associated with asthma treatment have been completed. Of these, 42 involved a product or products with a disclosed molecular target, 14 of which were first-in-class." Mr Mushtaq continues: "Investment in biologics, which would have been considered very risky just over a decade ago, has made a remarkable clinical and commercial impact across various indications, with biologics representing seven of the top 10 best-selling products in 2013. "With diversification in the current asthma treatment pipeline set to offer alternative therapeutic options to specific patients, investors can take advantage of the high-risk, high-reward opportunities available to gain a potential new portfolio addition," he concludes. ]]> <![CDATA[FICCI Life Sciences Vision 2030: Industry body's success mantra for companies]]> https://biospectrumindia.com/reports-white-papers/95/5993/ficci-life-sciences-vision-2030-industry-bodys-success-mantra-for-companies.html https://biospectrumindia.com/reports-white-papers/95/5993/ficci-life-sciences-vision-2030-industry-bodys-success-mantra-for-companies.html Mon, 08 Jun 2015 14:07:24 +0530 FICCI believes that by achieving this Vision 2030, the industry will continue making significant contribution to the economy and healthcare outcomes: âˆ? Industry will sustain its growth trajectory of 11 to 12 percent and grow 7 to 8 times to a size of $190 billion to $200 billion, driving 5 to 6 times growth in trade balance contribution to around $55 billion to $60 billion, reduction in energy imports and will also create nearly four million new jobs for the country over the next 15 years by the year 2030. âˆ? Will help India becoming the world's largest and most reliable drug âˆ? Providing every Indian access to high-quality, affordable drugs by adopting innovative models and government support, the industry can aspire to drive a 3-4 times increase in the number of treated patients across disease areas. âˆ? Building a global position for India in the innovation space and driving significant economic upside (exports of around $16 billion to $18 billion by 2030). How to realize Vision 2030? Six Imperatives for the Industry: FICCI believes that the industry could focus on six imperatives to enhance its competitiveness, deepen penetration and drive a common agenda to sustain growth under Vision 2030: 1. Building new techno-commercial capabilitiesDrive innovation at scale by making "smart" choices on the portfolio, building new techno-commercial capabilities, and revamping the operating model by using new approaches such as adaptive trial design to optimise approach for development. 2. Expand presence in emerging marketsThrough a focused approach and by building a "global" supply chain and organisation 3. Adopt innovative business modelsEnabling deeper penetration and access to drugs even in rural India, using technology to drive access and lower cost, providing integrated care for patients. 4. Upgrade quality systems and infrastructureBy enhancing capabilities to maintain India's image of a reliable, high-quality pharmaceuticals supplier through preventative care culture and capability building in the front-line. 5. Build new-age capabilities to sustain costBy speed-to-market advantage even across the newly emerging market segments, using automation and new technology to lower costs and ensuring "first time right" dossiers. 6. Collaborate more meaningfullyTo support growth the industry has to enhance capability building of quality teams across players. ]]> <![CDATA[FICCI seeks govt help in making enviornment conducive for business]]> https://biospectrumindia.com/news/95/5999/ficci-seeks-govt-help-in-making-enviornment-conducive-for-business.html https://biospectrumindia.com/news/95/5999/ficci-seeks-govt-help-in-making-enviornment-conducive-for-business.html Mon, 08 Jun 2015 14:05:48 +0530 FICCI has mentioned in its report, 'Vision 2030' that the government, on its part could consider supporting this vision by creating a conducive environment for the industry to undertake the above actions. The industry body has listed four imperatives for the government: 1. Build an enabling regulatory environment to facilitate the "ease of doing business" by providing clarity on guidelines in areas like clinical trials, approval pathway for different product categories. 2. Help improving the quality standards by strengthening the capacity/capability of quality inspectors and harmonizing the quality framework with global guidelines. 3. Ensure India's self-sufficiency by helping enhance competitiveness of the local API industry by setting up a dedicated API/intermediate manufacturing cluster with resource sharing and incentives. 4. Create a conducive environment for innovation by strengthening the local talent/research base at top academic institutions and enhancing incentives for investments in R&D. ]]> <![CDATA[Drugs Manufactured by Wockhardt recalled in the US]]> https://biospectrumindia.com/news/95/6110/drugs-manufactured-by-wockhardt-recalled-in-the-us.html https://biospectrumindia.com/news/95/6110/drugs-manufactured-by-wockhardt-recalled-in-the-us.html Mon, 08 Jun 2015 14:04:00 +0530 Captopril tablets, used in the treatment of blood pressure, and Clarithromycin antibiotic tablets manufactured by Wockhardt are being recalled in the US due to deviations in the current good manufacturing practice norms laid down by US Food and Drug Administration (US FDA). According to information on the US health regulator's website, 166 bottles of Captopril tablets of 50 mg strength are being recalled in the US. In case of Clarithromycin, the recall is for 50 bottles containing tablets of 500 mg strength. The recall is made by Blenheim Pharmacal, which packages and repackages Captopril and Clarithromycin, respectively. ]]> <![CDATA[Life Sciences industry generates $ 10 billion worth trade: FICCI report]]> https://biospectrumindia.com/reports-white-papers/95/5128/life-sciences-industry-generates-10-billion-worth-trade-ficci-report.html https://biospectrumindia.com/reports-white-papers/95/5128/life-sciences-industry-generates-10-billion-worth-trade-ficci-report.html Mon, 08 Jun 2015 12:06:46 +0530 Union health and family welfare minister, Mr J P Nadda released the FICCI knowledge paper titled "Indian Life Sciences: Vision 2030, Expanding Global Relevance and Driving Domestic Access" at Lifesciences Conference 2015, organized by FICCI in New Delhi on June. As per report, the Indian life sciences industry is now the third-largest contributor to reducing India's merchandise trade deficit. The industry generates around USD 10 billion of trade surplus every year, allowing it to neutralize around 4 to 5 per cent of total energy imports for India In addition, it also generates jobs and self-employment for around 2.5 million people. In pharmaceuticals, India is now the eighth largest country by value globally with one of the highest growth rates. It is strongly positioned in key overseas markets like USA. In clinical trials, India continues to be one of the top 15 destinations globally. Significantly, Indian drugs are available at affordable prices as compared to global markets. Further, India is the primary supplier of essential medicines for numerous diseases, helping save millions of lives globally. Indian medicine industry has also built strong value chain capabilities. In manufacturing, India continues to have the highest number of FDA-approved formulation plants outside the US. In R&D and regulatory, Indian industry has accounted for 32 per cent of the ANDA filings last year, second only to the US at 44 percent. However, under changing market dynamics the road ahead for the industry is challenging. Margins continue to be under pressure, driven by customer consolidation in developed markets and evolving regulations in few emerging markets. Cost position is under threat with new entrants in and Indian players are facing an increasing number of quality issues, affecting its supply reliability. Gaps in the industry's competitive ability have a considerable impact on the industry's ability to sustain its future growth. India's position in the innovation space continues to be nascent given that innovation could represent the next wave of growth for the industry. FICCI's estimates indicate that failing to address these issues could pull the growth rate down to 8 to 10 per cent over the coming years, also impacting the ability to serve the local market and maintaining its global position. It is, therefore, important for the industry and the government to come together and align on a common vision to help the industry unlocking its full potential. Vision 2030 builds on the successful trajectory of the Indian life sciences industry. It lays out the path forward to unlock the industry's true potential. This can become a reality if all the stakeholders collaborate and build on the strengths. ]]> <![CDATA[India, Netherlands sign MOUs on Measles-Rubella vaccine development]]> https://biospectrumindia.com/news/95/5125/india-netherlands-sign-mous-on-measles-rubella-vaccine-development.html https://biospectrumindia.com/news/95/5125/india-netherlands-sign-mous-on-measles-rubella-vaccine-development.html Mon, 08 Jun 2015 11:32:25 +0530 A Memorandum of Understanding was arrived at between India and Netherlands for the development of vaccines. The MoU signed under the 'Make in India' initiative of Government of India will enable Bharat Immunologicals and Biologicals Corporation Ltd (BIBCOL), a Central PSU under the Department of Biotechnology, to develop Measles - Rubella vaccine at its plant at Chola, Bulandshahr, UP Translational Vaccinology (INTRAVACC) a government-based institute of the Netherlands will extend technical support for the development of vaccine. The MoU was signed in the presence of the Prime Minister of The Netherlands, Mr Mark Rutte during his visit to New Delhi. Under the MoU cooperation in development of other vaccines and biologicals with DBT Research Institutes shall be explored. INTRAVACC, an institute which is part of the Ministry of Health, Welfare and Sport of the Netherlands, is internationally renowned for vaccine development and has a long history in technology transfer. Bharat Immunologicals and Biological Corporation Limited (BIBCOL), Bulandshahar, UP is a Central Public Sector Unit, under the Department of Biotechnology, Ministry of Science & Technology, Government of India. BIBCOL was established as a PSU in 1989, with the aim to achieve self-sufficiency for the nation with respect to production and supply of high quality polio vaccine and other biologicals. It has supplied billions of doses of oral polio vaccine to India's immunisation programme and has played a major role in making India 'polio free'. Under the 'Make in India' initiative of the Government, BIBCOL has embarked on journey to acquire technology and production capabilities for production of Measles-Rubella vaccine with the support of Department of Biotechnology. Dr Harshvardhan, minister for Science and Technology and Earth Sciences explained that the cooperation will result in large scale production Measles-Rubella and other needed vaccine of high quality in Bulandshahr, U.P. and save hundreds of thousands of children from the dreaded disease in the country. In the post polio eradication era, the focus shall be on elimination / control of other vaccine preventable diseases such as measles and rubella, he added. Mr Y S Chowdhary, Minister of State for Science & Technology and Earth Sciences lauded this as an example of how international collaboration and quality science can lead to entrepreneurship for public good. Prof K VijayRaghavan, secretary, Department of Biotechnology said that getting science and entrepreneurship to bear on the speediest production and deployment of vaccines is an important agenda of the Department. Mr Oudendijk, Director General of Intravacc, welcomed the broader collaboration as agreed upon in the MoU, since it is expected to provide innovative vaccine technology for the benefit of the people of India. Dr M K Bhan, chairman, BIBCOL commented that this important collaboration between BIBCOL and INTRAVACC will pave the way for manufacture of high quality affordable vaccines, beginning with Measles and Rubella vaccine, and then take on the production of the other needed vaccines for the Immunization Programmes of India and other developing countries in the world. The 'Make in India' is a critical initiative for promoting access to health technology beyond the borders of India. ]]> <![CDATA[Health ministry launches App to track progress on Mission Indradhanush ]]> https://biospectrumindia.com/news/95/7054/health-ministry-launches-app-to-track-progress-on-mission-indradhanush-.html https://biospectrumindia.com/news/95/7054/health-ministry-launches-app-to-track-progress-on-mission-indradhanush-.html Mon, 08 Jun 2015 11:29:51 +0530 Speaking in Shimla on June 04, where he launched the health Ministry's website on Mission Indradhanush, health minister, Mr J PNadda said that since December when the programme was launched, the central government has covered 40 lakh children of the 90 lakh it had mapped for this year. The health minister launched also launched a mobile application for field health managers, who will use it to update data which will reach the health minister on real-time basis. 10 high priority districts have been identified for vaccination programme 'Mission Indradhanush' to cover 90 percent kids by 2020. Mr Nadda said, "There has been a five percent increase in immunization in every phase since the launch of the campaign on April 7. The immunization program will ensure that no child is left un-vaccinated by 2020." Heh minister further said the ministry has set a target to bring the infant morality rate to single digits from the existing 28 per 1000 infants. Nadda said as part of this initiative, the government has inducted a new vaccine, Pentavalent (to combat diseases like Diphtheria, whooping cough and Tetanus) Hepatitis B and Hib vaccines. Nadda also launched a mobile application for field health managers, who will use it to update data which will reach the health minister on real-time basis. He said the immunisation program has been designed on lines of the successful polio programme to ensure that no child is left un-vaccinated by 2020. There will be increase of five per cent more children every year. ]]> <![CDATA[â€œSinopharm to launch 6 new products in India soonâ€? ]]> https://biospectrumindia.com/interviews/95/6647/sinopharm-to-launch-6-new-products-in-india-soon-.html https://biospectrumindia.com/interviews/95/6647/sinopharm-to-launch-6-new-products-in-india-soon-.html Sat, 06 Jun 2015 09:31:00 +0530 Now, Sinopharm India has set its sights high for the fast-growing India pharmaceutical market. Sinopharm India's managing director, Mr Alan Lear and the parent company's DGM for international trade, Mr Kevin Yuan, shared some of the future plans for the India market with Group Editor of BioSpectrum, Mr Narayanan Suresh, in an exclusive conversation in Shanghai in mid-May 2015 during The Health Industry Summit (THIS), organized by Reed Sinopharm: Excerpts: What has been the experience of Sinopharm in the India market so far?Alan: Though we have been distributing our products in India for nearly 15 years, it was only in January 2013 that we set up our own office with strong presence in New Delhi. We have supplying a range of biological vaccines made by our partner companies for many years. One of our leading products supplied to India is the Japanese Encephalitis(JE) vaccine to prevent the outbreak of this deadly disease in many states like Uttar Pradesh, Bihar and Assam. In fact, since 2006, we have supplied more than 170 million doses of JE vaccine to the Indian market and help reduce the burden of this disease significantly.Kevin: In fact, in April 2015, India government requested us to supply more doses of the vaccine for its adult immunization project to prevent JE in the state of Assam. We supplied the vaccine at the lowest cost in the world to the government. Any more new products in the pipeline for the Indian market?Alan: Sinopharm India is in the process of seeking registration for six new products in the country very soon. We are getting ready to launch our hepatitis B vaccine in India at the earliest. Another exciting product will be injectable intravenous human globulin which has been submitted to the Indian regulator, DCGI, for approval. We will be bringing a large portfolio of our blood products to the Indian market in the near future. Do you have any plans to manufacture any of these products in India itself?Alan: We are in discussion with some Indian companies to manufacture some of our products within the country itself. It may happen through the joint venture route and we may have some good news on this front soon. What about the API ( active pharmaceutical ingredient) business between both countries?Alan and Kevin: It is a two way business process. Sinopharm and its 11 subsidiaries and associate companies do a lot of business in API, intermediaries, vaccines and blood products. A lot of APIs in key areas like antibodies, antivirals, cardiovascular diseases, anti-cancer intermediaries, gastro intestinal disease are supplied to Indian companies. At the same time, Sinopharm imports a wide range of specialized APIs from Indian manufacturers. Will Sinopharm take some India-made products to the Chinese market too ?Kevin: Definitely. We are looking into this aspect. Currently, as the largest pharmaceutical group, we supply more than 3,000 products to the hospitals in China. Our products reach efficiently more than 90 per cent of the hospital network in the country. We promote efficient distribution and we are looking at ways to utilize this network even better with more products. ]]> <![CDATA[Ranbaxy in Sun's shadow! ]]> https://biospectrumindia.com/features/95/5904/ranbaxy-in-suns-shadow-.html https://biospectrumindia.com/features/95/5904/ranbaxy-in-suns-shadow-.html Sat, 06 Jun 2015 09:13:00 +0530 What goes up must come down too! This famous quote by Sir Issac Newton is apt to summarise the Ranbaxy's timeline. Like many successful businesses, the company too started on a humble note more than five decades ago. Despite its ups and downs ranging from quality issues to financial setbacks, it survived all along. However, the threshold was when it suffered worst after being bought by Daiichi Sankyo while Singh brothers exited the business. But with takeover by Sun Pharma through deal with Daiichi, there is a complete overshadowing of the once renowned band now left being as nothing more than a mere business unit. Ranbaxy's phenomenal journey: From rising to top and sliding down 1937: Ranbaxy started by Ranbir Singh and Gurbax Singh as a distributor for a Japanese company. 1961: Ranbaxy is incorporated.1973: Company went public.1997-98: Entry into US market. 2004: WHO detects quality issues in Ranbaxy's medicines.2005: Whistle blower exposes malpractices to USFDA. 2008: Daiichi acquires Ranbaxy in a deal worth $4.6 billion by acquiring a 63.92% stake in Ranbaxy. 2013: Company pleads guilty of clinical generic drug data and selling adulterated drugs to the United States, fined Rs 500 million by USFDA. 2015: Sun Pharma takes over Ranbaxy business from Diachii Sankyo. 2015: Ranbaxy ceases to exist as company. So what possibly went wrong? A New Delhi based pharma analyst calls it a mix of wrong policies and short sightedness. "The downfall started when Ranbaxy overlooked the concerns at the right time and continued to operate normally despite warnings. The waterloo moment was when the whistle blower removed the perfect company tag by exposing the quality issues at a global level. Aftermath was devastating for it," he mentions. Another school of thought however is not convinced with the argument. It says that the Ranbaxy is not the only company that has been caught in the web of quality issues. "There are so many examples of even non-Indian MNCs getting caught and let off after quality issues. But in Ranbaxy's case, it was just bad luck that one of its employee spilled beans and others too joined in," says a top pharma executive on the basis of anonymity. Daiichi's failed India aspirations The withdrawal from Ranbaxy business and sale of its shares by Daiichi Sankyo, after much hyped entry into India seven years ago has been completed with clear losses expected on investments. Daiichi on March 25, 2015 announced that it has decided to sell off the shares of Sun Pharma received following the completion of Sun Pharma's merger with Ranbaxy. "From the perspective of the improvement of corporate value, Daiichi Sankyo has performed a review of the Sun Pharma shares and reached a conclusion to sell the shares entirely or partially. After the sale, Daiichi Sankyo will not be a major shareholder of Sun Pharma. However, the existing business partnership with Sun Pharma will remain unchanged," said the statement from company. After its board approved the share sale to exit India, Daiichi sold its entire holding of 8.9 per cent in Sun Pharma on April, 28. As per Daiichi, it will make an announcement concerning the effect of any gain or loss on the sale of Sun Pharma shares during results of operations for the fiscal year ending in March 2015. However, in its statement to Bombay Stock Exchange (BSE), the company has mentioned that it will book a loss on sales of investment securities of 46.2 billion yen under extraordinary losses in its non-consolidated financial results for fiscal 2015. Daiichi got Rs 20,026 crore ($3.18 billion) which is technically about the same amount it had invested in rupee terms. However, there is still a loss compared to the dollar investment value of Daiichi which had invested through a mix of stake purchase from previous promoters, preferential allotment and open offer, giving it 63.92 per cent stake in Ranbaxy. Impact on 'Make in India' Seen as a silver lining in the dark clouds, the government's recent decision to allow FDI into two major Indian pharma firms is being seen as step to push indigenous manufacturing. The Cabinet Committee on Economic Affairs (CCEA), chaired by the Prime Minister, Mr Narendra Modi, on April, 07 approved qualified institutional buyers to infuse fresh equity of upto 7 percent amounting to about Rs 2165 crore into Aurobindo Pharma engaged in manufacturing generic pharmaceuticals and active pharma ingredients. Besides that $1 billion Glenmark Pharmaceutical's foreign investment limit by FIIs has been approved from 35.07 percent to 49 percent. This will result in an inflow of about Rs 2022 crore. Apart from manufacturing pharmaceuticals, the company is also engaged in Research and Development activities in drugs. The government is confident that it will help and exemplify "Make in India". Whether the picture is going to be as rosy as being claimed remains to be seen. Post its acquisition of Ranbaxy, Sun Pharma with its 10 percent of domestic market share, stands at the top. Therefore, its role in Make in India initiative cannot be ignored. This after company making it clear that intends to go for more acquisitions, points towards further strengthening of business. However, despite the strength, there are some outstanding issues that can spoil the party. Mr Tapan Ray, Independent Pharmaceutical Industry Analyst and Consultant wrote in his blog, "It is much well known though, that the US drug regulator has already imposed a ban on import of medicines into the US, produced at its key constituent Ranbaxy's India-based factories. Earlier, certain drugs produced at its Dewas plant of Ranbaxy were also barred from export to the entire EU region for non-compliance to GMP norms. On its own, the acquirer - Sun Pharma has also faced USFDA ban on import of products made at its Karkhadi plant in Gujarat. Taking all these into consideration, one can probably argue that the 'Make in India' issue for Indian pharma is humongous and quite a widespread one. Its adverse impact is very much palpable even at the very top." The trouble doesn't seem to be over yet for it at a time when the USFDA is stepping up scrutiny of India's pharmaceutical industry, which supplies nearly 40 percent of the drugs sold in the United States. Suddenly a new allegation has popped up on Ranbaxy's malpractices in past. A lawsuit filed in Boston court recently has accused it of conspiring for manipulating the U S Food and Drug Administration (USFDA) by putting up false or incomplete papers. The complaint that has named Sun Pharma mentions that the Ranbaxy as company intended to block competition while claiming 180 days of exclusive marketing rights. Road ahead: With Ranbaxy in its fold, Sun Pharma's 40 percent of the turnover comes from India and other emerging markets, and it has 45 manufacturing plants that make products for sale across 150 countries. The founder and managing director of Sun Pharma, Mr Dilip Shanghvi, has mentioned that Ranbaxy deal would not stop him from pursuing other big-ticket acquisitions. He said winning back the confidence of regulators would be the company's "most important focus", as it works to resolve quality control issues that have led to U S import bans on all of Ranbaxy's India drug manufacturing plants. Integration with Sun Pharma â¦? Value creation initiatives to deliver US$ 250 million synergies in 3 years. â¦? Combined entity structure to create opportunities for strong talent growth. â¦? 100 percent compliance, enhancing R&D productivity and strong business growth are the key priorities.â¦? Management Leadership Team to lead combined entity's next growth phase.â¦? Plans strong team of functional leaders drawing best of Sun Pharma and Ranbaxy. Sun is looking to increase its annual research spending to about $300 million from $250 million now. Remediation at manufacturing units which are currently in deviation from cGMP norms will remain a critical focus. Sun Pharma is working with global consultants assisting its internal teams to achieve compliance objectives. It has formalized an operational blueprint for realizing its US$ 250 million synergy target for year-3 through significant value creation across functions. The integration will cover all functions and markets globally. Whatever be the future, one thing is clear that Ranbaxy is no more. But then it leaves with Indian pharma industry, a list of experiences to learn from. What others can imbibe? âˆ? Focus on quality issues should be supreme.âˆ? Regulatory procedures shouldn't be undermined. âˆ? Financial dealings and professional conduct must be clean.âˆ? Investments in R&D can help in stronger original product pipeline. ]]> <![CDATA[Roche receives FDA nod for the cobas HSV 1 and 2 Test ]]> https://biospectrumindia.com/news/95/6382/roche-receives-fda-nod-for-the-cobas-hsv-1-and-2-test-.html https://biospectrumindia.com/news/95/6382/roche-receives-fda-nod-for-the-cobas-hsv-1-and-2-test-.html Fri, 05 Jun 2015 13:52:45 +0530 Roche has announced that the US Food and Drug Administration (US FDA) has provided 510(k) clearance for the cobas HSV 1 and 2 Test. The test is for the direct detection and differentiation of HSV-1 and HSV-2 DNA in anogenital specimens from symptomatic patients. With dual target detection and automation, the cobas HSV 1 and 2 Test provides laboratories with the capability to report up to 94 results in significantly less time than traditional methods. It also provides a simplified workflow for sample handling in the laboratory. "The addition of the cobas HSV 1 and 2 Test expands the menu for the cobas 4800 System, enabling labs to experience increased efficiency with innovative testing solutions. This highly sensitive and specific new test for the detection of herpes simplex virus delivers reliable results to physicians for optimal patient treatment and clinical management decisions," said Mr Paul Brown, head of Roche Molecular Diagnostics. The cobas HSV 1 and 2 Test offers accurate and reliable results through the use of simple and reliable sample collection technology and automated processing. The test is performed on the cobas 4800 System, currently the only FDA-cleared system which offers the flexibility to run sexually transmitted infection and healthcare-associated infection tests, in the same run, on a single platform. ]]> <![CDATA[FDA grants breakthrough therapy designation for Genzyme's Olipudase Alfa]]> https://biospectrumindia.com/news/95/6069/fda-grants-breakthrough-therapy-designation-for-genzymes-olipudase-alfa.html https://biospectrumindia.com/news/95/6069/fda-grants-breakthrough-therapy-designation-for-genzymes-olipudase-alfa.html Fri, 05 Jun 2015 12:43:03 +0530 Genzyme, a Sanofi company, has announced that the US Food and Drug Administration (US FDA) has granted Breakthrough Therapy designation to olipudase alfa. This enzyme replacement therapy is being investigated for the treatment of patients with non-neurological manifestations of acid sphingomyelinase deficiency (ASMD), also known as Niemann-Pick disease type B, as opposed to type A which is characterized by neurological involvement. ASMD is a serious and life-threatening disorder caused by insufficient activity of the enzyme acid sphingomyelinase (ASM), which results in the toxic accumulation of sphingomyelin. There are currently no approved treatment options for patients with Niemann-Pick disease type B. Breakthrough Therapy designation is intended to expedite the development and review of investigational new drugs that target serious or life-threatening conditions. The criteria for granting Breakthrough Therapy designation are preliminary clinical evidence of substantial improvement on a clinically significant endpoint over available therapies. The Breakthrough Therapy designation is distinct from the FDA's other mechanisms to expedite drug development and review, and will allow for a close collaboration between Genzyme and the FDA on the olipudase alfa development program. Olipudase alfa is being developed by Genzyme to potentially address the fundamental defect underlying the disease. Supplementing the defective or deficient native enzyme with olipudase alfa allows for the breakdown of sphingomyelin, whose accumulation is responsible for the clinical manifestation of ASMD. The Breakthrough Therapy designation is supported by data from a completed Phase 1b study of olipudase alfa. Findings in five adult patients with nonneuronopathic ASMD were presented at the Lysosomal Disease Network's WORLD Symposium in February 2015. The data presented on the repeat-dose safety, pharmacodynamics, and exploratory efficacy of olipudase alfa support its continued development for the investigational use in nonneurological manifestations of ASMD. The company has started enrollment of a Phase 1/2 pediatric study and is preparing for enrollment of a Phase 2/3 adult study in the second half of 2015. "There is tremendous unmet need in the ASMD/Niemann-Pick disease type B community, and we are hopeful that olipudase alfa can be developed into a meaningful treatment for patients. We appreciate the FDA's support for this important program giving us the opportunity to utilize an important expedited drug development pathway for olipudase alfa and providing hope for patients affected with a chronic and progressively debilitating disease," said Dr Richard Peters, Genzyme's Global Head of Rare Diseases. ]]> <![CDATA[Fidelity Growth Partners invest in Medwell Ventures]]> https://biospectrumindia.com/news/95/6073/fidelity-growth-partners-invest-in-medwell-ventures.html https://biospectrumindia.com/news/95/6073/fidelity-growth-partners-invest-in-medwell-ventures.html Fri, 05 Jun 2015 12:37:19 +0530 Medwell Ventures, the operator of Nightingales speciality home healthcare services, has announced that the Fidelity Growth Partners India (FGPI) and Fidelity Biosciences, Boston have acquired a significant minority stake in the company with a $10 million investment. Bangalore-based Medwell was established in March 2014. Following the acquisition of Nightingales Home Health Services, the company has grown rapidly. It recently established operations in Hyderabad and is currently in the advanced stages of a Mumbai launch; it plans to build its network across ten metro clusters in India and increase its subscriber base to cover over 500,000 families. "The healthcare delivery ecosystem in India needs innovative solutions with scalable business models. Over the next 15 years, chronic diseases will cost India Rs 280 trillion. We have a strong conviction that speciality home healthcare is one of the key solutions to managing the rising trend of high cost chronic diseases in the country. This investment by Fidelity is a validation of our model and a recognition of the evolving Indian healthcare delivery landscape," said Mr Vishal Bali, chairman and co-founder, Medwell Ventures. Dr Prem Pavoor, managing director at Fidelity Growth Partners India (FGPI) said, "This investment reflects FGPI's keen interest in partnering with distinctive management teams to build leaders within still emerging segments in the healthcare and life sciences industry in the country. We see tremendous potential for a clinically focused, world-class provider of chronic care healthcare services at home. Fidelity is excited to partner with Vishal, Ferzaan, Lalit and Himanshu in this phase of Medwell's growth." BMR Advisors acted as the sole financial advisors and BMR Legal acted as legal advisors to Medwell Ventures for this transaction. Terms of the transaction were not disclosed. ]]> <![CDATA[HealthifyMe launches calorie tracking via Twitter]]> https://biospectrumindia.com/news/95/7159/healthifyme-launches-calorie-tracking-via-twitter.html https://biospectrumindia.com/news/95/7159/healthifyme-launches-calorie-tracking-via-twitter.html Fri, 05 Jun 2015 11:46:31 +0530 Now anyone can send a tweet to @HealthifyMe with the hash tag #TweetToTrack and names of the foods/drinks they ate and HealthifyMe will respond back with the calorie and nutrition values for the same. For instance if a tweet "@HealthifyMe 2 idlis, Sambar #TweetToTrack" is sent, HealthifyMe responds back with "211 calories." HealthifyMe was the first one to launch a dedicated Indian calorie tracking app in 2013 on the Android PlayStore and with this innovation, it is extending its ability to twitter, which has over 22 million Indians. Mr Tushar Vashisht, CEO and co-founder of HealthifyMe said, "We are committed to promote healthy living and the motive of this campaign is to extend the power of our calorie tracker to all Indians who have access to twitter. Even those who do not have the HealthifyMe app can now get benefit from our comprehensive Indian foods database. This is one step further in our endeavour to Healthify India" HealthifyMe is owned by Caeruz Ventures and aims to simplify healthy living. At the heart of HealthifyMe's platform is the World's First & largest Indian Calorie Tracker, which allows users to track their food, exercise and weight, easily via their smartphone or computer while continuously analyzing the user's data and provide powerful insights that ensure that users stay within their calorie/nutrition budgets. HealthifyMe uses a combination of cloud-powered software (smartphone application), hardware (wearable activity trackers, weight trackers) and human assistance (nutritionists, trainers and yoga instructors) that helps people eat better, workout more, lose weight and become fit. The company claims that using experts and technology, today over 100,000 users have benefitted from HealthifyMe and met their goals - be it weight loss, eating healthy or staying fit. HealthifyMe is also used in clinical settings such as Apollo and Medanta in Delhi and Manipal Hospital in Bangalore in conjunction with the Endocrinology, Cardiology and Preventive Health Centers. ]]> <![CDATA[World Environment Day: Indian farmers urge govt to allow GM technology to address climatic change ]]> https://biospectrumindia.com/news/95/4390/world-environment-day-indian-farmers-urge-govt-to-allow-gm-technology-to-address-climatic-change-.html https://biospectrumindia.com/news/95/4390/world-environment-day-indian-farmers-urge-govt-to-allow-gm-technology-to-address-climatic-change-.html Fri, 05 Jun 2015 11:29:32 +0530 On the eve of World Environment Day, the Confederation of NGOs of Rural India (CNRI), an association of NGOs representing 7,000 NGOs and 200,000 self-help-groups across India, issued a statement urging the Union environmental minister, Mr Prakash Javadekar to accelerate genetic engineering technology for farmers and agriculture and make it a priority focus area to help combat disease, pests and climate change challenges in India. CNRI through its partners recently engaged with over 3,000 farmers across the key agricultural states of Bihar, West Bengal, Jharkhand, Madhya Pradesh, Maharashtra, Rajasthan, Punjab, Gujarat, Uttar Pradesh and finally Karnataka (the only state from the southern part of India to participate in this exercise) seeking their inputs on issues of climate change and its effect on agriculture. These included a mix of small farmers and marginal farmers. CNRI representatives also met with large farmers, i.e. those holding land in excess of five acres. The results were collated primarily from Kharif, Rabi and Zaid growing regions across these ten states. In addition to lack of irrigation and limited access to bank credit, the biggest concern expressed by farmers was the lack of quality seeds as per the multi-agro climatic zones and usage of breeding technologies like agriculture biotechnology applications to combat climate change - primarily drought, unseasonal rains and increasing soil salinity in semi-arid and arid regions. CNRI found that farmers across these ten states were keen to ask the government to accelerate the development of seeds through new breeding techniques which can be achieved through agriculture biotechnology applications. This would enable the application of water-use-efficiency along with nitrogen-use-efficiency to help grow crops with less water and reduced application of nitrogenous fertilizers. Other agri-biotechnology traits such as yield improvement traits, herbicide tolerant traits and others are also being demanded by farmers to enable higher yields. Highlighting the findings, the CNRI National President, Dr Raghupati Singh said, "On the eve of World Environment Day I would like to share the anguished cry for help of the Indian farmer with the environment mi nister, Mr Prakash Javadekar. The Indian farmer needs technological help to combat the ill-effects of climate change. Indian farmers want the success of Bt cotton replicated with other crops and have them genetically modified to combat the ill-effects of climate change. The application of genetic engineering in agriculture will lead to higher yields and assured supply and result in consumers benefitting through reduced or stable prices for agricultural products." He further emphasized that the "BIMARU" states would never come out from their poverty syndrome. Surprisingly states like Gujarat, West Bengal & Telengana are treading on the path of these "BIMARU" states. CNRI also takes this opportunity to give a clarion call to the governments of Gujarat, Tamil Nadu, West Bengal & Rajasthan to allow field trials of GM crops to generate relevant scientific data so that ill-conceived myths around the safety of GM crops can be busted. It also requests organisations like Bharatiya Kisan Sangh and Swadeshi Jagaran Manch to create a consensus amongst all stakeholders concerned with genetic engineering technology. CNRI also requested crusaders like Ms Vandana Shiva and noted Supreme Court advocate Prashant Bhushan to talk with scientific facts and evidence before creating hurdles to utilize the best of these technologies for the benefit of rural India. Dr Raghupati Singh further said, "In this time of crisis, Prime Minister Narendra Modi's recent statements saying that he wants farmers to be self-reliant and economically prosperous has ushered in a new ray of hope among us. Modiji believes that technology applications in agriculture can pave the way to an ever-green revolution. We support and endorse this and urge his government to enhance the agri-economy by giving farmers access to new genetically engineered seeds that will enable them to mitigate the effects of climate change." India is self-sufficient in cereals only but not in pulses and oil-seeds where it is a net importer. India is importing over 3 million tonnes of pulses alone. Similarly almost 50% of India's edible oil requirements is imported. A recent report by the agriculture ministry states that India's food-grain production will report a decline of 3 percent in 2015 as compared to the previous year. The total food-grain production is estimated to be 257.07 million tons in current crop year (July-June period) as compared to 265.57 million tons in 2013-14.This decline has occurred on account of lower production of rice, coarse cereals and pulses due to erratic rainfall conditions during monsoon season in 2014. Farmer suicides have risen 50 per cent increase in suicides in the January-March period, after crop damage due to unseasonal rains. According to figures from the Ministry of Agriculture, the total of number of suicides committed by farmers for agrarian reasons in the last three years stands at 3313. Maharashtra alone has witnessed over 200 suicides this year alone. India's population is expected to reach 1.5 billion by 2025 and the need for additional food-crops will put huge pressure on existing agricultural land or marginal soils. No single approach such as conventional crop improvements alone will help increase crop production (that will require to double by 2050). Crop losses due to climatic conditions, insects, pests, diseases and declining soil fertility, will also need to be factored in to apply genetic modification of crops. ]]> <![CDATA[DBT, Cambridge University ink research pact]]> https://biospectrumindia.com/news/95/6768/dbt-cambridge-university-ink-research-pact.html https://biospectrumindia.com/news/95/6768/dbt-cambridge-university-ink-research-pact.html Fri, 05 Jun 2015 08:03:00 +0530 India has partnered with the UK's prestigious Cambridge University to create a new programme of early-career fellowships in the field of biotechnology. The fellowships will be funded jointly by the University of Cambridge and by the Department of Biotechnology (DBT), to support research and innovation projects in collaboration with Indian partner institutions. It was announced during a recent visit to the varsity by minister of state for Science and Technology, Mr YS Chowdary. Under the terms of the agreement, academics participating in the scheme will be jointly appointed by the DBT and Cambridge. They are expected to spend two years in Cambridge and three years at a partner institution in India carrying out translational research, with a focus on commercialization and entrepreneurship. It also makes reference to a shared interest in the establishment of a centre for crop sciences, and to Cambridge's plans for the establishment of a wholly-owned not-for-profit subsidiary in India to support wider collaborative research between Cambridge and Indian Institutions. "We are delighted to be partners of India's Department of Biotechnology in establishing these fellowships. We are also very eager to support the DBT's plans for the development of India's research ecosystems through closer links between universities and industry. This is another great example of Cambridge's commitment to enhancing its engagement with India in ways that will strengthen the capacity for translational and applied research in both India and the United Kingdom," said the university's vice-chancellor Dr Leszek Borysiewicz. ]]> <![CDATA[Proklean Technologies raises Rs 3.5 cr to advance probiotic technology]]> https://biospectrumindia.com/news/95/7125/proklean-technologies-raises-rs-3-5-cr-to-advance-probiotic-technology.html https://biospectrumindia.com/news/95/7125/proklean-technologies-raises-rs-3-5-cr-to-advance-probiotic-technology.html Thu, 04 Jun 2015 13:11:34 +0530 Proklean Technologies Pvt. Ltd., a probiotic product manufacturing company based out of Chennai, has secured Rs 3.5 crores from India's premier management institution, IIMA CIIE's sustainability and cleantech fund Infuse Ventures. IIMA-CIIE is backed by Government of India's Ministry of New and Renewable Energy (MNRE) and Technology Development Board, IFC, BP, Godrej Industries, ICICI Bank, SIDBI, Bank of India and Union Bank. Proklean had earlier raised an angel round from the Chennai Angels, fellow IIMA students and SCD Probiotics, USA. Proklean manufactures completely natural probiotic products that can replace or reduce the use of chemicals in various industrial and commercial applications like leather processing, textile processing and household cleaning. All products are sold under the brand name Proviera. Proklean claims that the company uses a unique probiotic technology which makes the products 100% bio-degradable, natural and non-toxic. Founded by Dr. Sivaram Pillai, B. Chandrasekhar and Vishwadeep Kuila, the company has already developed a suite of products for the textile and leather processing industries with marquee names in India like Vardhaman group, Raymond, Mafatlal, Welspun, RSWM, Kapoor Industries, JK Mills, AVT, Super House, Upper India, already as customers and internationally for the customers in USA, Brazil, Mexico, South Africa, Germany, Spain, Hungary, Turkey, Thailand, China, Philippines, Australia and Bangladesh. IIMA-CIIE's fund Infuse has been investing actively in the cleantech sector and its investments includes energy-management startup Ecolibrium Energy, thermal-energy storage startup Tessol, renewable energy services startup REConnect, solar-pumping startup SuryaPowerMagic and geothermal HVAC provider GIBSS among others. ]]> <![CDATA[Cipla's HIV drug for children gets FDA nod]]> https://biospectrumindia.com/news/95/6453/ciplas-hiv-drug-for-children-gets-fda-nod.html https://biospectrumindia.com/news/95/6453/ciplas-hiv-drug-for-children-gets-fda-nod.html Thu, 04 Jun 2015 11:56:52 +0530 Cipla has announced that it has received the United States Food and Drug Administration (US FDA) approval for its innovative formulation, Lopinavir/ ritonavir (LPV/r) 40mg/ 10 mg oral pellets, for paediatric specific treatment for infants. The pellets are to be sprinkled on sweetened porridge for infants and administered to them. The pellets are produced by melt-extrusion technology and are enclosed in capsules. Cipla has been working for many years in collaboration with Ms Diana Gibb, Professor of Epidemiology, Senior Programme Leader and Honorary Consultant Paediatrician at Medical Research Council Clinical Trials Unit at UCL (University College London) towards development of this novel child-friendly formulation which has been approved by the US FDA under the President's Emergency Plan for AIDS Relief (PEPFAR) program. "We are extremely proud to have developed this innovative formulation of LPV/r oral pellets for infants and young children. Cipla has been committed to the cause of HIV/AIDS for over two decades. This innovative way of drug delivery through oral pellets for some of society's youngest AIDS sufferers reiterates our commitment to provide access to life saving medicines in the fight against HIV/ AIDS," said Mr Subhanu Saxena, MD and Global CEO, Cipla. Dr Jaideep Gogtay, chief medical officer, Cipla said, "Lopinavir/ Ritonavir is a preferred antiretroviral in paediatric patents and this unique drug delivery system is a breakthrough in paediatric specific treatment for infants. The traditionally available antiretroviral liquid formulations and tablets have their own challenges when it comes to treating infants. LPV/r oral pellets 40 mg/ 10 mg should be used in combination with other antiretroviral agents for the treatment of HIV-I infection in paediatric patients weighing 5 kg and above and who can have semi-solid food." ]]> <![CDATA[PPP helps make indigenous diagnostic kit for foot and mouth disease in livestock]]> https://biospectrumindia.com/news/95/7170/ppp-helps-make-indigenous-diagnostic-kit-for-foot-and-mouth-disease-in-livestock.html https://biospectrumindia.com/news/95/7170/ppp-helps-make-indigenous-diagnostic-kit-for-foot-and-mouth-disease-in-livestock.html Thu, 04 Jun 2015 11:27:55 +0530 The official launch of the DIVA Diagnostic Kit for Foot and Mouth Disease took place recently in the presence of Dr KML Pathak, Deputy Director General (Animal Science), ICAR. The kits have been manufactured by private partner, Arsh Biotech with the know-how transferred by Project Directorate on Foot and Mouth Disease (PDFMD), Mukteswar. Dr Pathak said "this is the best demonstration of "Make in India" initiative and the partnership has set a stage for industries and technology developers to exchange skills and knowledge and create business opportunities in animal health sector. The ChallengeFoot-and-mouth disease (FMD) is a major livestock disease of transboundary importance, affecting cloven-hoofed animals including cattle, pigs, goats and sheep. It is estimated that the annual direct economic loss due to FMD in India is around Rs. 20,000 crores. Therefore, development of rapid and precise diagnostics facilitating DIVA would be valuable in the sero-surveillance of FMD when active immunization is ongoing. ApproachAgrinnovate India worked collaboratively with the Private Partner and the Research Institute, PDFMD to fully define and fulfil the requirements of client. The plan involved the training of personnel from the private partner at PDMFD, Mukteswar on the production of FMD reagent kits and associated quality assurance (QA) procedures, and testing and formulation of safe operating procedures (SOPs). ResultThe Public Private Partnership (PPP) has resulted in the on-time launch of improved kits that contain all the necessary ready to use reagents for detecting Foot and Mouth Disease virus (FMDV) which is compact and convenient and have commercial documentation for best user experience. ]]> <![CDATA[Data integrity concerns still prevalent among pharma companies: EY survey]]> https://biospectrumindia.com/reports-white-papers/95/8182/data-integrity-concerns-still-prevalent-among-pharma-companies-ey-survey.html https://biospectrumindia.com/reports-white-papers/95/8182/data-integrity-concerns-still-prevalent-among-pharma-companies-ey-survey.html Thu, 04 Jun 2015 11:26:13 +0530 One third of pharmaceutical companies have not conducted reviews to assess potential gaps in data integrity, according to an EY survey, 'Analysing the state of Data Integrity Compliance in the Indian Pharmaceutical Industry'. Data integrity reviews are conducted to evaluate if data records are accurate, complete, attributable, legible and maintained within their original context in electronic or paper form. Over 30 percent of the respondents stated that they have received inspectional observations by regulators. This was despite signing off their understanding and compliance with Good Manufacturing Practices (GMP) norms. Mr Arpinder Singh, partner and national leader, Fraud Investigation & Dispute Services, EY said, "The pharmaceutical industry has been a buoyant sector in the eyes of domestic as well as foreign investors. But at the same time, the industry is still struggling to deal with challenges around pricing in domestic market, increased regulations as well as data integrity. Companies need to take these issues seriously, especially those around data integrity as it is a critical aspect within the overall compliance framework." "Maintaining data integrity is crucial for the pharmaceutical sector. Today, companies with existing or anticipated concerns around data integrity should initiate regular proactive data integrity assessments. This will be beneficial even for companies that enjoy a good reputation in the market. These periodic assessments provide assurance to all stakeholders involved - customers, investors, regulators as well as reaffirm the management's commitment toward highest standards of quality." adds Rajiv Joshi, Partner, Fraud Investigation & Dispute Services, EY. Dr Ajaz S. Hussain, advisor, EY and Former Deputy Director, Office of Pharmaceutical Science, US Food and Drug Administration (US FDA) added, "Integrity of data is the foundation on which we make decisions on quality, safety and efficacy. Recording of data and information with accuracy protects life; without it, we cannot differentiate between counterfeit and authentic medicines. At the end, any lapse in the assurance of data integrity is a serious deviation from expected practices and can have adverse repercussions. The EY survey is an apt reminder - a means to improve awareness and to communicate this important message." EY's Fraud Investigation & Dispute Services team conducted the survey to assess the state of compliance related to Data Integrity Compliance faced by pharmaceutical companies. Some key highlights of the survey are: Technology upgrade is the need of the hour 25 percent were unaware of the 21 Code Federal Regulation (CFR) Part 11 standards prescribed by the US FDA which establishes the criteria to record data in electronic form. 33 percent mentioned to have shared employee login ids and passwords for laboratory systems such as High Performance Liquid Chromatography (HPLC), Gas Chromatography (GCs). This shows that organizations still need to make a significant headway for being compliant with global standards. It is important that the management pays more attention to these requirements, as failure to do so can invite regulatory and/or penal consequences. Work pressure and shortage of manpower affects quality compliance Over 57 percent of the employees agreed to have seen work pressure on the manufacturing personnel to meet Key Performance Indicators (KPIs) such as volume of output, low rejection ratio and overall equipment effectiveness. 18% did not have adequately staffed Quality Assurance teams to review the manufacturing and testing of all the products independently. This indicates that shortage of manpower or excessive work pressure can lead to inaccurate or incomplete documentation, and eventually could impact the product quality. Absence of quality process and procedures 33 percent respondents did not conduct reviews to assess potential gaps in assurance of data integrity. It has been observed that regular and proactive data integrity reviews can ensure accuracy and consistency of GMP data. 13 percent respondents did not have clearly documented Standards Operation Procedures (SOP) on backup and deletion of laboratory data files generated by HPLC or GCs. Lapses in data integrity continue to rise More than 30 percent of respondents had received inspectional observations such as Form 483s, warning letters, import alerts, Statement of non-compliance with GMP etc. issued by global regulators. 21% stated that audit trails on laboratory equipment are not always enabled in their organizations. Absence of audit trails can be a serious problem as there would be no records of data captured which could lead to severe action by regulators. Setting up whistle-blowing frameworks, still work in progress 28 percent of respondents indicated that their organisations did not have a fraud reporting mechanism in place. In such a guarded industry, lack of whistle-blowing policies means individuals who genuinely want to help their organizations by flagging any unethical acts or wrongdoings may be forced to report such issues externally. ]]> <![CDATA[International regulatory non-compliance is serious challenge to life sciences sector growth, discloses Deloitte survey]]> https://biospectrumindia.com/reports-white-papers/95/6273/international-regulatory-non-compliance-is-serious-challenge-to-life-sciences-sector-growth-discloses-deloitte-survey.html https://biospectrumindia.com/reports-white-papers/95/6273/international-regulatory-non-compliance-is-serious-challenge-to-life-sciences-sector-growth-discloses-deloitte-survey.html Thu, 04 Jun 2015 09:00:00 +0530 Although the numbers are not available, the economic impact of non-compliance of international regulatory by the life sciences sector in the last five years is very high. The non-compliance due to various reasons is a serious challenge to growth of the sector and is going to hold growth of companies. "Nobody has counted it in numbers but it was needed to be computed and the opportunity loss cannot be counted," said Rohit Mahajan, Senior Director, and Nitin Bidkar, Director, Deloitte Touche Tohmatsu India Private Limited, while releasing the survey report 'Managing growth through better compliance management' here today. Mahajan said about 50 plus companies were banned by the regulators from abroad for non-compliance so it can be very roughly guessed that the loss was somewhere around 5 to 7 % of the total revenue. The anonymous survey was done to assess the industry' preparedness for zero tolerance level of the regulators, to understand compliance culture and to capture behavior culture for compliance of the companies. About 50 companies exporting products from among top life science 100 companies that included pharmaceuticals, medical devices, biotechnology, were approached for the survey and 33 responded. The survey was launched in August 2014. Deloitte concentrated on this area because of increasing monitoring by regulators abroad of Indian pharma sector and manufacturing facilities. One of the main reasons for non-compliances has come out to be shortage of skilled staff as claimed by 64%, 55 percent of survey respondents have indicated that their compliance teams were not adequately trained to address regulatory requirements. Besides talent shortage, lack of an efficient internal control/ compliance system (61 percent of survey respondents), inadequate utilization of technology to identify red flags (45 percent), and lack of a zero tolerance approach towards noncompliance and malpractice (45 percent) were indicated as key contributors to noncompliance and malpractice in the sector. Further, 30 percent of survey respondents said they had experienced noncompliance with GxP guidelines in the last two years. However, 45 percent said they had not experienced any type of noncompliance. The Indian pharma sector is growing 15 to 20 % CAGR year on year and expected to be worth $55 billion by 2020 and majority of that revenue will be coming from exports, Bidkar said. He informed that in India there are 546 facilities approved by USFDA, 847 by UKMHPH and 1295 by WHO-GMP. Over 50 facilities were banned for non-compliances, he added. In addition, "in the last two years, most regulatory bodies have introduced new areas of scrutiny beyond just testing drug efficacy, and now involve risk management and mitigation programs for R&D laboratories, manufacturing facilities and procurement functions. For compliance management professionals to familiarize themselves with these changes and become adequately trained in them requires time. In the interim, companies could be exposed to vulnerabilities arising from non-compliance," said Mahajan. Industry was evolving, Mahajan pointed out, this was the transition issue that the sector was facing. Even developed countries faced this problem of transition. The only difference was that in India we were also in response, he added. Both Mahajan and Bidkar denied the possibility of manipulation by respondents saying that they have not done any ranking of the companies on compliance and hence no industry or industry person would be interested in manipulating their responses. If fact, Bidkar said even industry wanted to know the realistic picture and where they stand. He informed that US and UK have begun the process of ranking the companies on compliance basis. The survey report said around 48 percent of respondents confirmed that compliance strategy was not a key area earmarked for investment in their organizations, indicating that perhaps senior management did not consider this area as a high risk with serious consequences in the event of non-compliance. "Organizations that view fraud risk management and compliance management as strategic activities, are able to identify instances of noncompliance and work towards mitigating such incidents. Unless the life sciences sector looks at compliance management strategically, it will not be able to make the necessary investments in tools and technology to build a robust control environment that can mitigate non-compliance," said Mahajan. On detection of fraud, noncompliance and malpractice, 76 percent of respondents indicated relying on whistleblowing channels. Upon detection of fraud 85 percent of respondents said they launched an internal investigation by a specially appointed committee, while 82 percent confirmed that some form of disciplinary action was initiated as per existing policies and fraud and compliance risk management frameworks. The survey report also discusses the key types of noncompliance observed in the sector along with providing a roadmap for organizations to build an effective compliance management system. ]]> <![CDATA[Perrigo to acquire a portfolio of OTC brands from GSK]]> https://biospectrumindia.com/news/95/7384/perrigo-to-acquire-a-portfolio-of-otc-brands-from-gsk.html https://biospectrumindia.com/news/95/7384/perrigo-to-acquire-a-portfolio-of-otc-brands-from-gsk.html Thu, 04 Jun 2015 08:49:00 +0530 Perrigo has announced that it has entered into an agreement to acquire a portfolio of well-established over-the-counter (OTC) brands from GlaxoSmithKline Consumer Healthcare (GSK). This is in connection with GSK's commitments to the European Commission and other regulators to divest these businesses in the context of the formation of a consumer health joint venture between GSK and Novartis International. Perrigo will acquire the GSK's NiQuitin nicotine replacement therapy (NRT) business, primarily in the European Economic Area (EEA) and Brazil, and Novartis's legacy Australian NRT business, including the Nicotinell brand; Several assorted OTC brands including Coldrex (cold and flu treatment) across the EEA, and Panodil (pain relief), Nezeril (nasal decongestant), and Nasin (nasal decongestant) in Sweden; and Novartis's legacy cold sore management products primarily in the EEA, marketed under the brand names Vectavir, Pencivir, Fenivir, Fenlips and Vectatone. The company will acquire these in an all-cash transaction in which the purchase price was not disclosed. "This acquisition demonstrates Perrigo's ability to execute on our 'Base Plus Plus Plus' strategy, in which we make selective, accretive transactions to expand our durable base business. We are building on the global platform we established with the Omega Pharma acquisition to capture an even greater share of the $30 billion European OTC market opportunity with several well-established, complementary brands that bolster our OTC product portfolio. We are committed to making investments in these brands to grow their market positions in key geographies, by following Omega Pharma's proven approach to brand building," said Mr Joseph C Papa, chairman, president and CEO, Perrigo. He added, "Perrigo is uniquely positioned to maximize the potential of these brands by leveraging Omega Pharma's leading European commercial infrastructure, pan-European distribution network, strong brand-building capabilities, and exceptional management team. This announcement comes on the heels of our recent acquisition of European OTC dermatological product, Vitasil, which recently closed. With our global platform in place and our robust balance sheet, we are ideally positioned to execute immediately accretive deals, such as this one, that will have a multiplier effect on our growth." The acquisition is expected to be immediately accretive to Perrigo's calendar 2015 adjusted earnings per share, excluding estimated intangible amortization and transaction-related costs. The transaction has been unanimously approved by the Boards of Directors of Perrigo and GSK, and is expected to close in the third quarter of 2015, pending approval by the European Commission, the Australian Competition and Consumer Commission, and Brazil's Council for Economic Defense, as well as the satisfaction of customary closing conditions. ]]> <![CDATA[Actavis completes the acquisition of Auden Mckenzie]]> https://biospectrumindia.com/news/95/6022/actavis-completes-the-acquisition-of-auden-mckenzie.html https://biospectrumindia.com/news/95/6022/actavis-completes-the-acquisition-of-auden-mckenzie.html Wed, 03 Jun 2015 11:32:49 +0530 Actavis has announced that it has completed the acquisition of Auden Mckenzie Holdings, a company focused on the development, licensing and marketing of niche generic medicines and proprietary brands in the UK. The company acquired Auden Mckenzie for approximately $470 million (£306 million) in cash, plus a two-year royalty on a percentage of gross profits of one of Auden Mckenzie's products. "The acquisition of Auden Mckenzie is a strategic combination that makes Actavis the number one generic company in the UK and aligns with our strategy to establish a leading position in all of our markets, franchises and therapeutic categories," said Mr Brent Saunders, CEO and president of Actavis. "Auden Mckenzie's expertise in the development and commercialization of high value, technically demanding formulations as well as specialized and niche opportunities is complementary to and expands Actavis' UK business focus. The opportunity to combine this profitable and growing company into the Actavis UK business demonstrates our commitment to invest in and expand strategically in our global generics business," said Mr Robert Stewart, executive vice-president Actavis, and president, Generics and Global Operations. The combination with Auden Mckenzie adds approximately 175 new generic and branded products, as well as a pipeline of approximately 40 additional products, in various dosage forms, for treatments across a broad spectrum of therapeutic areas, to the company. ]]> <![CDATA[Telehealth: IAP-Healthphone launched to address malnutrition in India]]> https://biospectrumindia.com/news/95/6284/telehealth-iap-healthphone-launched-to-address-malnutrition-in-india.html https://biospectrumindia.com/news/95/6284/telehealth-iap-healthphone-launched-to-address-malnutrition-in-india.html Wed, 03 Jun 2015 11:25:00 +0530 The formal launch of the IAP HealthPhone program, the world's largest digital mass education programme to tackle the challenge of malnutrition in women and children at the national-level in India was done on June 02, 2015 at New Delhi. IAP HealthPhone is a public private partnership initiative by Indian Academy of Pediatrics (IAP) and HealthPhone and supported by Vodafone India. It is a unique program that leverages the increasing penetration of mobile phones in the country to educate over 6 million girls and women between 13 and 35 years of age and their families on better health and nutrition practices by 2018. The program will achieve its objectives by widely promoting and distributing four re-edited videos from the Poshan series, jointly produced by MWCD and UNICEF in 18 Indian languages. The Poshan videos address issues of status of women, the care of pregnant women and children under two, breastfeeding and the importance of balanced diet, health and simple changes in nutritional care practices that can notably enhance nutrition levels. To kick start the program, IAP has forged a unique partnership with Vodafone India to encourage the viewing of the four videos. Vodafone will enable its customers to view/download the videos free of data charges and on viewing the 4 videos, the user will receive a talk time incentive of Rs 10/-. Vodafone will send out approximately 300 million text messages to its subscribers every year to promote the viewing of the four videos. It will also support IAP to undertake a comprehensive communication campaign to promote the IAP HealthPhone program across the country via print and social media. IAP HealthPhone partners are committed to strengthen the program through their networks and sync their efforts to address malnutrition systemically. As next steps they will equip AWW, ASHAs and ANMs with a HealthPhone microSD card, containing a library of videos, to enable them to share health & nutrition knowledge with women, families and the communities they serve. It will also partner with social media giants (such as Facebook, Twitter and Google) to use their exponentially growing channels to reach more - rural and urban - caregivers. The three-year campaign by IAP HealthPhone is expected to benefit the health of 60 million children in India born by 2025 and will be transformative for India's fight against malnutrition. ]]> <![CDATA[Top 7 science and medicine trends for 2015]]> https://biospectrumindia.com/reports-white-papers/95/7277/top-7-science-and-medicine-trends-for-2015.html https://biospectrumindia.com/reports-white-papers/95/7277/top-7-science-and-medicine-trends-for-2015.html Wed, 03 Jun 2015 10:55:00 +0530 The health sciences are constantly pushing toward more effective treatments and cure. The question is: where will we see the next breakthroughs? These range from basic science to digital health, from aging research to cancer treatments, and from approaches in the lab to access at the hospital 1. Hacking the brain Significant and technological advances are ushering in an era that would have been unimaginable to early brain scientists. Long lasting implants employing hundreds or thousands of electrodes can be placed in the brain to both deliver stimulation and to 'listen to brain activity for signs of trouble. "Powerful new tools allow researchers to monitor activity patterns across brain circuits, bringing us closer to understanding how perception, thought and action arise from different circuits," said Phillip Sabes, PhD, professor of Physiology. Eventually, Professor Sabes said this technology will allow amputees and patients with paralysis to directly control artificial limbs with brain signals, will predict and head off epileptic seizures, and will better treat Parkinson's disease and other movement disorders. In addition, UCSF scientists are exploring the possibility that brain implants could ease the symptoms of - and perhaps even cure - psychiatric disorders including anxiety, depression, and addiction. 2. Breakthroughs in Teamwork Scientists are embracing a multidisciplinary team effort to make the most increasingly powerful and opens up new complex ways to tackle problems. This is in stark contrast to the competitive nature of rival scientific labs of the past to be first out of the gate with important findings. Take genomic research, for example. Since increased risk for many diseases may reside in very rare, difficult-to-find mutations, many researchers have begun assembling large international research groups to freely share data. "One of the major drivers of recent progress has been a wholesale shift in culture. Investigators who were once fierce competitors are now finding ways to collaborate with one another in large-scale, multi-site genomic studies," said Matthew State, MD, PhD, chair of Psychiatry. Two recent collaborative studies of the genetics of autism involved 50 laboratories worldwide and uncovered more than 100 genes linked to the risk of autism. Before this work, smaller efforts had identified only 11 genes that confer a risk for autism. Nothing succeeds like success, so expect to see more "shared science" in the coming years. 3. Diagnosing Disease through DNA "Next-generation DNA sequencing" allow lab workers to read out the equivalent of an entire genome's worth of sequence in a day DNA - for less than $1,000. Now this technology has begun to be used as diagnostic tools. Next-generation sequencing offers unprecedented throughput, scalability and speed that could have untold impacts on studying disease, biology and clinical research, said Charles Chiu, PhD, director of UCSF Viral Diagnostics and Discovery Center. "We are gradually moving away from using next-generation sequencing exclusively as a powerful research tool and we are starting to use it in the clinic," said Dr. Chiu. His team used the technology to identify the cause of life-threatening meningitis within 24 hours, saving the life of a 14-year-old boy after all standard diagnostic tools failed. After sequencing all the DNA found in his spinal fluid, from the patient's own DNA to bacteria and viral DNA, scientists were able to identify the culprit as an unusual, but easily treated bacterial infection. Dr. Chiu is now working on applying this technology to develop a rapid diagnostic test for the Ebola virus. 4. Rejuvenation through the Blood Sound straight out of a vampire novel? Well, a recent study led by Saul Villeda, PhD found that infusions of young blood can perk up the brains of older mice. The Sandler Faculty Fellow made front-page news with these findings when his team identified evidence of cognitive improvements in the old mice after they were connected to the circulatory systems of younger mice. At the same time, a team at Stanford University found that young blood could help rejuvenate heart muscle, too. In fact, young blood seems to improve muscle, liver, heart and brain - discoveries that have spurred a quest for the specific molecules responsible for rejuvenation. "Today it seems as if everyone is going after molecules in the blood that might help reverse biological aging. There also are factors that can be removed from old blood to slow aging, and we want to explore these, too," said Dr. Villeda. As the search continues, he and his collaborators already have launched a small clinical trial to test young blood in Alzheimer's disease. 5. Prime Time for Telemedicine Telemedicine is finding its place in modern medicine, especially in American health care, according to Seth Bokser, MD, MPH, to allow experts to consult remotely via virtual office visits, radiological readings and even remote ICU monitoring. "Telehealth is the right technology for our times. Americans want high quality, personalized care. Providers and patients alike are beginning to trust information technology with their health," said Dr. Bokser, medical director for IT at UCSF Benioff Children's Hospital. Additionally, as primary care doctors are retiring, rural areas are struggling more than ever, and community hospitals need cost-effective ways of providing both primary and specialty care. While nothing can replace an in-person visit, t, especially when patients are experiencing new symptoms, telemedicine is finally coming into its own. 6. Breaking Down Cancer Categories Genome-sequencing technology now has broken down cancer as a diverse collection of diseases demanding a wide range and combination of treatments.. Today's powerful sequencing technology is allowing scientists to examine tumors letter by genetic letter, with surprising results.In 2014, a study partly led by UCSF scientists suggested that these new techniques could lead to more accurate diagnoses for as many as one in 10 patients. "For the first time ever, we're able to pinpoint to important molecular features shared by cancers that affect different tissues. This will have huge implications for therapy as we begin to design treatment plans based on a cancer's molecular signature," said Denise Wolf, PhD, computational biologist at UCSF Helen Diller Comprehensive Cancer Center. Combined with decades' worth of accumulated clinical experience, such insights are already leading to radical new treatment recommendations. 7. Systems Pharmacology Molecular biology transformed the field of pharmacology by allowing researchers to isolate and purify the particular receptors through which drugs acted. Yet 30 years after first focusing drug research on the molecular level, fewer drugs have since been discovered - and at greater expense. To spur drug development, many researchers say the focus needs to be on both molecular and systemic impacts. This emerging field, known as systems pharmacology, integrates the behavior of molecules to understand the effects of drugs on the whole organism. "Scientists can now design molecules with exquisite potency and specificity for particular receptors, and by combining this knowledge with our understanding of whole body systems, there's huge potential for a rebirth of pharmacology," said Brian Shoichet, PhD, professor of Pharmaceutical Chemistry. (Article courtesy Industry Sourcing. This article was published in Show Daily supplement published during The Health Industry Summit held in China) ]]> <![CDATA[Dr JN Verma conferred 'Haryana Vigyan Ratna' Award]]> https://biospectrumindia.com/news/95/4629/dr-jn-verma-conferred-haryana-vigyan-ratna-award.html https://biospectrumindia.com/news/95/4629/dr-jn-verma-conferred-haryana-vigyan-ratna-award.html Wed, 03 Jun 2015 10:52:56 +0530 The managing director of Lifecare Innovations, Dr Jitendra N Verma, was on May 22, 2015 conferred with the "Haryana Vigyan Ratna" for his outstanding contributions in lifesciences by the state's Chief Minister, Mr Manohar Lal Khattar in an award function in Chandigarh. Dr Verma's career in science as an academician, scientist and industrialist spans over four decades. As founder of the Gurgaon-based Lifecare Innovations which was incorporated in the year 2000, he pioneered development of NDDS based Liposomal and Nano-Drugs and is a leader in Liposome Technology applications for drugs, diagnostics and vaccines. He developed and commercialized India's first Liposomal product and world's only Liposomal diagnostic - Liposome agglutination test for Syphilis. Speaking with BioSpectrum, Dr Verma expressed his happiness at being repeatedly recongnized by various state governments and now Haryana. He appreciated and thanked Mr ML Khattar for bestowing the state's scientific honor on him. He contributed to Asia's first and world's best antifungal drug FUNGISOME, a Liposomal Amphotericin B. Working on malaria vaccine, Dr Verma was first to report that Liposomal vaccines elicit cellular immune response necessary for protective immunity. He developed five new drugs and three new diagnostics to take from lab-bench to patient care. He is presently developing Liposomal and Nano-Drugs for the treatment of Leishmaniasis, Fungal infections, Malaria, Tuberculosis and Cancer. Keenly involved in translational research for taking benefits of Science & Technology by applications in everyday life, Dr Verma has a number of publications, reviews and patents to his credit. He is recipient of the title of Vigyan Ratna from State Governments of UP and Haryana, Scientist of the Year from Gyan Chand Jain Memorial Trust, DST- Lockheed Martin (USA) Gold Medal, Technium Challenge Award from Welsh Assembly Government UK, recognition from National Innovation Foundation & ICMR besides several other awards & honors. Dr Verma is acclaimed for promotion of R&D and commercializing their outcome by industry-academia interactions and public-private partnerships. In addition to basic research in Life-Sciences and product design, development and manufacture for healthcare, Dr Verma has been working on Bio-Entrepreneurship Promotion, development of regulatory guidelines for Medical Diagnostics, and disseminating knowledge about safe medicines. Having earned his masters degree fom Allahabad University and PhD from PGIMER, Chandigarh, he engaged in medical research at the University of Pennsylvania, Northwestern University, and Georgetown University in USA. He was Senior Associate of National Research Council of US National Academy of Science at Walter Reed Army Institute of Research in USA. ]]> <![CDATA[DATRI successfully facilitates its 100th blood stem cell donation ]]> https://biospectrumindia.com/news/95/4994/datri-successfully-facilitates-its-100th-blood-stem-cell-donation-.html https://biospectrumindia.com/news/95/4994/datri-successfully-facilitates-its-100th-blood-stem-cell-donation-.html Wed, 03 Jun 2015 09:57:29 +0530 DATRI, India's largest blood stem cell donors registry dedicated to saving lives of people suffering from life threatening blood disorders, recently marked a significant milestone of completing 100th unrelated blood stem cell donation. Mr. Gopal Vachhani, 44 yrs. old working in Dubai became the 100th donor and under the supervision of Dr. Paresh Vyasa (Consultant, Transfusion Medicine) the collection took place in Apollo Hospitals, Ahmedabad. Mr. Vachhani is the fifth life saver from Dubai, registered under DATRI. DATRI has successfully completed over 638 blood stem cell registration drives across India and currently has built a database of over 92,000 donors from different ethnic backgrounds in India who have voluntarily registered themselves with DATRI. On 26th April 2011, Mr. Ajit Kumar Das from Odisha was the first voluntary blood stem cell donor whose wonderful act of kindness was facilitated by DATRI at Apollo Hospitals, Chennai. Since then, DATRI has helped unite strangers at birth to become blood brothers and sisters for life. Speaking on the occasion, Dr. Paresh Vyasa said "Every Matched Unrelated Donor (MUD) of blood stem cells is not less than GOD to the recipient and DATRI plays the role of an angel to make it happen. Congratulations to DATRI for igniting rays of hope in the darkness of 100 patients. My appeal to people is to grab this opportunity to save someone's life. " Blood cancer can affect anyone and the chances of finding a cure within one's own family is just 25%. If no cure is possible from siblings, the patients have to look out for voluntary blood stem cell donors from specialized registries like Datri who maintain a database of the HLA types of the volunteers who register in a simple process during the blood stem cell registration drives referred to above. Patients need donors who are a close genetic match. More than a lakh of people have been diagnosed with blood cancer in India and the numbers are increasing at an alarming rate every passing year. Besides, 15,000 children are diagnosed with life threatening disorders like thalassemia and blood cancer annually. Sharing his thought on completing 100 donations, Mr. Raghu Rajagopal, Co-founder & CEO, DATRI said, "It is a proud moment for me and for everyone associated with DATRI. Reaching a milestone of 100th donation was not easy for us, particularly in our country where the awareness levels on this issue is very low. I am thankful to Mr. Vachhani who flew down to India especially for the donation. We need many more such kind souls to come forward and register with us as nothing can be more self-satisfying than giving someone a new lease of life." "The awareness about peripheral blood stem cell transplant is low in India and the number of registered donors is not significant at all, despite our country being home to 1.2 billion people. If there are 20 million registered donors in the world, in India with a population of 1.2 billion, there are just over one lakh registered prospective blood stem cell donors. We hope that we will be able to make a difference to many more lives and at the very least find a matched donor for the over 1,000 patients who have reached out to us and are still looking for a match" added Raghu Rajagopal. ]]> <![CDATA[AstraZeneca and Sun Pharma ink distribution deal for ticagrelor in India]]> https://biospectrumindia.com/news/95/6011/astrazeneca-and-sun-pharma-ink-distribution-deal-for-ticagrelor-in-india.html https://biospectrumindia.com/news/95/6011/astrazeneca-and-sun-pharma-ink-distribution-deal-for-ticagrelor-in-india.html Tue, 02 Jun 2015 12:37:32 +0530 AstraZeneca Pharma India and Sun Pharmaceutical Industries on June 02, 2015 announced that they have entered into a distribution services agreement for AstraZeneca's brand "Axcer", a new brand of ticagrelor, a drug used for the treatment of acute coronary syndrome (ACS) in India. AstraZeneca already has a brand under the trademark "Brilinta", for the ticagrelor molecule, launched and marketed by it in India since 2012. Sanjay Murdeshwar, managing director, AstraZeneca Pharma India said, "We are pleased to collaborate with Sun Pharmaceuticals to bring this innovative treatment solution to a larger number of ACS patients in India. Ticagrelor works by preventing the formation of new blood clots and maintains blood flow in the body, helping reduce a patient's risk of another heart attack or cardiovascular-related death." Abhay Gandhi, CEO - India Business, Sun Pharma commenting on the partnership said, "We are happy to collaborate with AstraZeneca to provide customers access to this latest generation treatment option for ACS. Such collaborations are also a part of our stated policy of becoming the partner of choice for promotion and distribution of innovative pharmaceutical products in the country." Sun Pharma will be promoting and distributing the "Axcer" brand in India. This collaboration enables AstraZeneca to expand usage of this molecule through wider reach to physicians and thereby benefiting a greater number of ACS patients. It strengthens Sun Pharma's cardiology portfolio with the addition of a new patented therapy. ]]> <![CDATA[â€œIndia needs to show the way in TB eliminationâ€? ]]> https://biospectrumindia.com/news/95/7306/india-needs-to-show-the-way-in-tb-elimination-.html https://biospectrumindia.com/news/95/7306/india-needs-to-show-the-way-in-tb-elimination-.html Tue, 02 Jun 2015 12:36:48 +0530 Note: India is home to millions of tuberculosis (TB) patients and estimated 40 percent of Indian population is infected with TB bacteria (mostly latent). Q: Have there been any major changes in the TB control programme in India in recent years? There are some significant spectacular changes that happened in the meantime. There were lot of efforts by the leadership to keep the right policies in place. Among these were the major breakthroughs that TB was made notifiable, giving blood for diagnosis of TB and creation of electronic record systems for registration. There was a steep increase in the number of multi-drug resistant (MDR)-TB cases detected and treated in India. It is one of the largest cohorts in India. However, the steps taken in last three years have been assuring. That is why we are energised. This is the reason we think that India is not just committed but also part of bigger elimination programme. Q: What are your expectations from the health ministry's latest 'Call to action for TB control' initiative? This call to action for TB control is more of an advocacy programme. I have immediate expectations of increased levels of awareness from it. And it is good signal that the health minister is himself coming to such events and exhibiting enthusiasm. The participation of stakeholders is welcome and we have to go to another level. Health minister can do as much but we also require support from finance ministry and prime minister's office as well. At ground level, what is required is the increase in level of awareness among both local people and healthcare workers. With huge TB burden, I say if India is moving then world is moving. Eyes are on India and it has to lead the way for others to follow and say if India can do, we can do too. Q: Rolling out of such a huge programme requires finances? How do you plan to go about that? There is a threat alive and there is a big opportunity too. The funding from national government and state governments is not that small. And national strategy plan here has a price tag attached to it. We require hundred thousand dollars but it didn't look like a scary figure to government which says it will do the needful. However, besides the government allocations, then you have the active global funds. There is a loan from World Bank but it is still the money. So I think the money per say is not a big issue but the system to make it work is the issue. In terms of implementation, if things are in place, people will run with it. But to get to that level, there are various stops. One of thing is the funding available for molecular technology to change whatever is available now to develop options for future. But the problem is that it takes months for moving. If we take the months of procurement and then deployment, there are discrepancies. This is the need for urgency, we are all talking about. Q: What will be the role of Stop TB Partnership in these whole consortia? We majorly play the role of high level advocacy. Based in Geneva, we travel frequently and work with partners here to interact with the prime minister's office and also the other higher offices. We work with those groups that already support the Indian TB programme. One is Global Poverty Action Fund (GPF) which is doing the full line procurements with external funding for second and third line of drugs. Besides that TB Reach which is funding the large scale innovation projects by identifying the right individuals and organizations. We are developing the global plan to support BRICS countries where TB burden is 50 percent of global burden. India alone has a major part out of this burden and if it will drive the initiative along with China and South Africa, we can surely achieve great results. Q: Does the TB elimination by 2019 look realistic? What according to you are the challenges that stand before us? Well it looks possible given the enthusiasm but a lot of work has to be done in reality. I think that the real challenge is harmonization of treatment. From the WHO estimates, it appears that there is a certain burden and there are lot of people that are unaccounted for. Biggest challenge will be to ensure that the people wherever they go receive same treatment and quality as well. It is to make the private sector play the ball with public sector and we are here to ensure that. We would see to it that there is TB free India. ]]> <![CDATA[BIRAC announces Industry Innovation Program on Medical Electronics (IIPME)]]> https://biospectrumindia.com/news/95/7102/birac-announces-industry-innovation-program-on-medical-electronics-iipme.html https://biospectrumindia.com/news/95/7102/birac-announces-industry-innovation-program-on-medical-electronics-iipme.html Tue, 02 Jun 2015 11:46:27 +0530 The Biotechnology Industry Research Assistance council (BIRAC) has announced the launch of the Industry Innovation Program on Medical Electronics (IIPME) with an aim to promote and foster cutting edge technologies in the field of Medical Electronics. BIRAC through its various flagship schemes is making significant investments in the medical devices sector and hence, promoting the R&D of medical devices. The IIPME will directly target innovations in medical electronics startâ€?ups, SMEs and large enterprises and will also help in generating the ideas to keep ready the pipeline of new unmet medical Innovations. To achieve the desired impact the IIPME will fund the innovations in three categories Seed Grants (Idea to PoC), Early Transition, Transition to Scale. The Expression of Interest (EoI) and further the proposals received under the three phases will undergo a rigorous screening process which will shortlist and evaluate the proposed innovation. The proposals will be evaluated online by the area review panel comprising of experts from various academic institutes. The shortlisted proposals will be called for presentation to the Technical Screening Committee at BIRAC and will be further screened. The shortlisted projects will be evaluated in detail by the technical and financial due diligence team at the company site and the projects which will clear all these phases will be finally approved for funding by the Apex approval board. The first call of IIPME is open for addressing challenges in the Medical Electronics arena where health informatics and electronics can be integrated with medical requirements. The call will remain open till 30th June 2015 and proposals are invited online through its website www.birac.nic.in. ]]> <![CDATA[iLife Discoveries introduces a gene test to diagnose cancer recurrence]]> https://biospectrumindia.com/news/95/7011/ilife-discoveries-introduces-a-gene-test-to-diagnose-cancer-recurrence.html https://biospectrumindia.com/news/95/7011/ilife-discoveries-introduces-a-gene-test-to-diagnose-cancer-recurrence.html Tue, 02 Jun 2015 11:44:00 +0530 Adding a powerful new tool to the existing modality of breast cancer management, genetics and genomics company, ILife Discoveries has introduced a revolutionary new gene test that will help oncologists get a deeper insight into tumors and assist them in deciding if chemotherapy can be avoided in some cancer patients. By giving a better understanding of biology of a tumor, the Not all cancers have the same physiology, nor do all tumors follow the same path of development. This is why chemotherapy, the difficult yet indispensible tool in cancer treatment is not needed in all patients. However, given the lack of our ability to predict course of disease and its risk of recurrence, doctors currently practice a blanket approach in treating all patients cancer, risk of recurrence of early stage cancer, thereby enabling medical oncologists to take informed decisions on the course of treatment. For millions of breast cancer patients in India, the twin technologies are advancements that can shed new light on whether treatment is possible without undergoing the harsh chemotherapy process. Speaking on the occasion of the launch of gene test, Mr Anand Gupta, founder and CMD, iLife Discoveries mentioned, "The biology of each tumor is different. Apart from the stage of detection, an important component of treatment success is the physiology and subtype of the cancer with some subtypes having better prognosis as against others. Not all patients need to go through the difficult and challenging chemotherapy after a surgical procedure to kill chances of cancerous cells recurring. However, in the absence of reliable mechanisms to provide efficient insight into the cancer and the possibility of its recurrence, most oncologists take recourse to the tried and tested chemotherapy mechanism. The MammaPrint and Blueprint technology can help doctors reduce the use of unnecessary chemotherapy by identifying the risks and its need." "As a surgical oncologist, I am concerned about the removal of cancerous tumor from the breast of a patient either through mastectomy or a lumpectomy. Unfortunately in some women the breast cancer still spreads. Until now we did not have any test to distinguish women in which cancer would spread from the women in whom it would not. But now we have an FDA approved 70 gene Mammaprint test, by which we can predict the behavior of tumor by looking at its genomic profiling and manage the patient accordingly," said Dr Ramesh Sarin, senior consultant, Surgical Oncology, Indraprastha Apollo Hospitals, New Delhi. "Most therapies which are administered to treat breast cancer are quiet toxic so it is better to select and use the suitable therapy for the appropriate women. The blueprint assay categorizes breast cancer patients into 4 different categories according to underlying tumor biology. Blueprint along with MammaPrint helps us to pick and choose a proper treatment for the patient based on their specific functional subtype and overall risk of recurrence," said Dr Ajay Sharma, medical oncologist, Rajiv Gandhi Cancer Hospital. Dr Amit Verma, molecular oncologist at Max Hospital, Saket said, "A great need exists for better molecular characterization of tumor tissue as this would help in oncology decision-making process, facilitate treatment selection, and improve outcomes. Unlike previous-generation genomic tests, MammaPrint evaluates all of the critical molecular pathways involved in the breast cancer metastatic cascade. BluePrint pairs nicely to provide more individualized information regarding the molecular subtype of the tumor". The area of DNA sequencing to predict cancer prognosis and development has gained attention in recent years. Actor and humanitarian Angelina Jolie had in 2013 generated much attention to gene tests that could identify the future risk of a woman suffering breast or ovarian cancer. MammaPrint is a 70-gene assay intended as a prognostic test for women of all ages. Through the gene test results, patients are stratified into two distinct groups - low risk (good prognosis) or high risk (poor prognosis) of distant recurrence. Unlike other tests, the patient is given definitive Low Risk and High Risk results, eliminating the uncertainty of an intermediate risk score which can affect up to 39 percent of patients tested. These results, in addition to all other factors help you and your doctor make the most appropriate breast cancer treatment decisions. High risk MammaPrint patients show a statistical benefit from adjuvant chemotherapy, with the FDA reporting a result accuracy of 98.5 percent and classification accuracy of 97.7 percent on repeat testing. Blueprint is a molecular subtyping assay used in addition to the MammaPrint test in a target population of patients with early-stage (stage I or II) breast cancer. By identifying the breast cancer subtype, BluePrint allows determination of a patient's potential level of responsiveness to chemotherapy more accurately as compared to IHC/FISH technologies, with better correlation to long-term clinical treatment outcomes. ]]> <![CDATA[Tobacco kills nearly 6 million people a year globally: WHO]]> https://biospectrumindia.com/news/95/5070/tobacco-kills-nearly-6-million-people-a-year-globally-who.html https://biospectrumindia.com/news/95/5070/tobacco-kills-nearly-6-million-people-a-year-globally-who.html Mon, 01 Jun 2015 16:59:37 +0530 Countries are constantly defining ways to curb tobacco consumption. These measures together with strong pictorial warnings have brought substantial health care gains. "Tobacco kills nearly 6 million people each year, globally. Unless we act now, the epidemic will kill over 8 million people every year by 2030. More than 80% of these preventable deaths would occur in low- and middle-income countries," said Dr Poonam Singh, WHO regional director, South-East Asia. However, illicit trade undermines tobacco control policy efforts and facilitates increased uptake of tobacco by youth and adults from low-income groups by making tobacco products more affordable and accessible, particularly to those from low-income groups. "And because these products are not subject to legal restrictions and effective health regulations aimed at curbing tobacco use, such as pictorial warnings or banning sales to minors, this is fuelling the tobacco epidemic," Dr Poonam added. In the South-East Asia Region, many countries have porous borders that provide easy opportunity for the smuggling of tobacco products. All South-East Asian countries have enacted stringent laws to control tobacco consumption - both on pricing and sale of tobacco products in-country as well as against import of foreign brands - and despite these efforts, there is still a thriving trade in smuggled tobacco products. In a bid to respond to growing illegal trade in tobacco products and to make a consolidated effort to put a break in this cycle of illegal transactions, The Protocol to Eliminate Illicit Trade in Tobacco products was developed. This international treaty was negotiated by the Parties to the WHO Framework Convention on Tobacco Control (FCTC), and was adopted by them in November 2012. WHO urges all Member States to speed up their process of ratifying or acceding to the Protocol. "Ratification of the Protocol is necessary to respond to the financial, legal and health impacts of illicit trade in tobacco products," concluded Dr Poonam. ]]> <![CDATA[DNDi & Pharma Cos announce 'Drug Discovery Booster']]> https://biospectrumindia.com/interviews/95/6431/dndi-pharma-cos-announce-drug-discovery-booster.html https://biospectrumindia.com/interviews/95/6431/dndi-pharma-cos-announce-drug-discovery-booster.html Mon, 01 Jun 2015 12:21:50 +0530 The Drugs for Neglected Diseases initiative (DNDi) and four pharmaceutical firms, Eisai, Shionogi, Takeda Pharmaceutical, and AstraZeneca have announced the start of a ground-breaking initiative to accelerate and cut the cost of early stage drug discovery for two of the world's most neglected diseases, leishmaniasis and Chagas disease. The 'Neglected Tropical Diseases Drug Discovery Booster' consortium, through a carefully engineered modus operandi, will circumvent early stage commercial barriers between the four pharmaceutical participants, allowing DNDi, for the first time, to search millions of unique compounds simultaneously, in the hunt for new treatment leads for leishmaniasis and Chagas disease. 'This experimental approach to radically modernize drug development for neglected diseases is the result of a decade of growing partnerships with pharmaceutical companies. This experiment could significantly reduce the time and money it takes to find new, promising treatment leads, and echoes the great potential of innovative research and development collaborations,' said Dr Bernard PÃ©coul, executive director of DNDi. The innovation of the Drug Discovery Booster not only lies in the multilateral approach, but also in the iterative nature of the search, meaning companies will continually examine their libraries for better matches as the search is refined. The Drug Discovery Booster has the potential to cut up to two years from the early drug discovery process, which takes approximately five years or more, and improve cost-efficiency across research activities. The new process starts with DNDi providing all four companies with a common chemical starting point, the 'seed' compound. This compound will have shown promising results against Leishmania or Trypanosoma cruzi, the parasites that cause leishmaniasis and Chagas disease, but may not yet be optimal for use as a future treatment. The four companies will then search their own full collections of high-quality chemical compounds for similar and potentially better molecules, and will select and send the most promising to DNDi, which will then have them screened for potential effectiveness against these two deadly parasitic diseases. The aim is to continually improve the effectiveness of the compounds. DNDi will then select the best 'hits' for further testing. This process will be repeated up to three times, with each new iteration or round starting from an improved seed compound identified from within one of the four partner's collections and shared with all. The initial project goal is to explore the consortium's compound libraries for at least four promising seed compounds for each disease. It is expected that at least two of the resulting novel series of compounds will move to the next stage of development towards a new medicine. Any progress or successful new treatment for leishmaniasis or Chagas disease resulting from the Drug Discovery Booster will be attributed to the collective effort of all partners, which have also agreed that no intellectual property barriers will be imposed to a new treatment if successful. The GHIT Fund, launched in 2013, stimulates and supports such international global health research and development partnerships. Through a grant of approx. $ 701,284 (EUR 640,000 or 79.5 million Japanese Yen) provided to DNDi, GHIT will support the involvement of the three Japanese companies in this project. The remainder of the project, including the involvement of AstraZeneca, is being supported by DNDi core funds. 'The Drug Discovery Booster could be a game-changing milestone in the fight against diseases that destroy the health and livelihoods of the world's poorest. Industry's innovative leadership for the most neglected of the neglected diseases will be essential to accelerate progress toward creating life-saving medicines, and GHIT is proud to support the important contribution of Japanese pharmaceutical companies to make this possible,' said Dr BT Slingsby, GHIT Fund CEO. ]]> <![CDATA[AstraZeneca inks pact with Dr Reddy's ]]> https://biospectrumindia.com/news/95/4781/astrazeneca-inks-pact-with-dr-reddys-.html https://biospectrumindia.com/news/95/4781/astrazeneca-inks-pact-with-dr-reddys-.html Mon, 01 Jun 2015 12:07:14 +0530 AstraZeneca (AZ) Pharma India and Dr Reddy's Laboratories (DRL) have entered into a distribution agreement for two drugs Riax and Riax-M. The drugs are used for the treatment of diabetes. Riax and Riax M are trademarks of the AstraZeneca group. DRL will be distributing these two drugs in the country. "Diabetes is a disease of epidemic scale in India with over 65 million affected people. This partnership reflects our constant endeavour to enhance patient's access to novel treatment solutions like saxagliptin," said Mr Sanjay Murdeshwar, managing director, AstraZeneca Pharma India, in a statement. "We are committed to addressing unmet needs of diabetes patients in India and are pleased to partner with AstraZeneca in launching saxagliptin and its combination with metformin (another anti-diabetic drug), an important addition to our diabetes franchise," said Mr Alok Sonig, senior vice-president and head of India Business. AstraZeneca already has two brands under the trademark Onglyza and Kombiglyze for saxagliptin and infixed dose combination with metformin respectively, promoted and distributed in the Indian market. ]]> <![CDATA[DBT to fund nanobiotech research for cancer cure]]> https://biospectrumindia.com/news/95/4739/dbt-to-fund-nanobiotech-research-for-cancer-cure.html https://biospectrumindia.com/news/95/4739/dbt-to-fund-nanobiotech-research-for-cancer-cure.html Mon, 01 Jun 2015 12:03:23 +0530 As per DBT, the nanobiotechnology enabled system may offer revolutionary advantages for the better treatment of complex disease like cancer. Therefore, aiming to promote and provide opportunities to the scientists working at the interface of cancer biology and nanobiotechnology, the Indian government's premier biotechnology organization has asked for proposals built upon innovative ideas related to translational nano medicine to address various issues in treatment of cancer by undertaking studies in the areas. The proposals in areas such as novel nano formulations of already approved chemodrugs to improve the bioavailability, PK/PD, tumour specificity and reduction of toxicity, nanoscale modifications of clinical chemodrugs leading to significant improvement in the mode of action, PK/PD and toxicity profile; nano engineering for finding new targets for existing chemo drugs; dentifying novel translational biomarker for nano medicine targets; mplantable local drug delivery platforms for anti-cancer drug delivery; endogenous protein / biomineral nanoparticles based drug delivery systems; synergistic anti-cancer activity of nanoparticles in combination with chemodrugs. Research ideas that could be considered are in areas like nanobiotechnology based novel strategies for overcoming in vivo barriers; radio-frequency ablation using nanoparticles; photo-thermal ablation using nanoparticles, nanoparticle assisted magnetic hyperthermia, nano-RNAi system for siRNA and miRNA delivery and nano-gene delivery, anti-cancer nano-peptide therapy, nanoparticles assisted monoclonal therapy, molecularly targeted cancer nanomedicines, nano medicine targeted to drug resistance mechanisms. Interested applicants can submit full proposal on DBT format online through epromis system available on its site. Last date of submission is June 30, 2015. ]]> <![CDATA[ICAR organizes brainstorming sessions on seed spices plant genetic resources]]> https://biospectrumindia.com/news/95/6806/icar-organizes-brainstorming-sessions-on-seed-spices-plant-genetic-resources.html https://biospectrumindia.com/news/95/6806/icar-organizes-brainstorming-sessions-on-seed-spices-plant-genetic-resources.html Mon, 01 Jun 2015 11:33:22 +0530 Dr RS Paroda, former secretary, DARE and DG ICAR and now chairman TAAS, inaugurated a one day workshop-cum-brainstorming session on "Strategies to strengthen seed spices plant genetic resources and burning issues of cumin and coriander" at ICAR-National Research Center on Seed Spices (NRCSS), on 27th May 2015 Seed spices are low volume and high value crops of the arid and semi-arid India. These crops also possess high export and medicinal value. Dr Paroda in his address emphasized upon the need to have strong PGR's conservation facility dedicated to seed spices, he also suggested to explore seed spices genetic resources in a much intensified manner. Dr RR Hanchinal, chairman, PPV & FRA presided over the function, advised to take up minor seed spices under DUS program for safeguarding national wealth. Dr SB Dandin ex-vice chancellor, University of Horticultural Sciences, Bagalkot was the Guest of Honour. He shared his views for the roadmap for seed spice improvement at national level. Dr Balraj Singh, director, ICAR-NRCSS gave an overview of the activities of NRCSS. Scientists and experts from ICAR institutes and state agricultural universities particpated in the deliberation. Experts from various participating Institutes suggested points for the betterment of PGR in seed spices. Challenging problems of cumin and coriander i.e. Alternaria blight of cumin and stem gall of coriander were also deliberated to find ways for efficient management of both the diseases. It was suggested to study the basic aspects of plant interaction and also to screen large no of germplasm in the hot spots for developing disease resistant varieties. ]]> <![CDATA[GAVI: committed to India's immunization campaign ]]> https://biospectrumindia.com/news/95/7552/gavi-committed-to-indias-immunization-campaign-.html https://biospectrumindia.com/news/95/7552/gavi-committed-to-indias-immunization-campaign-.html Mon, 01 Jun 2015 10:47:55 +0530 Following recent reports regarding the withdrawal of funding by GAVI, the organization has now issued clarification on the matter. While it has not denied that it would be eventually curtail its funding support in the next five years but has trashed claims that its move would in any way affect the Indian immunization campaign. In a media statement issued recently, it mentioned, "An article published recently in an Indian newspaper stated that Gavi was withdrawing funding from India, thereby jeopardising the Government of India's ongoing efforts to improve immunization coverage. That is not the case. We remain a committed partner of India and we will continue to support the country in its endeavours to immunize more of its children against life-threatening diseases." GAVI currently supports pentavalent vaccine which offers protection against five diseases (diphtheria-tetanus-pertussis (DTP), hepatitis B, and Haemophilius influenzae type b) as well as providing funding to help India to strengthen its health systems. Between 2000 and 2015, the alliance has disbursed more than US$ 240 million to help India to immunse its children against life-threatening diseases. Additionally, GAVI has committed $107 million to support health systems strengthening in India, which is likely to play a role in the success of Mission Indradhanush, over the next five years. Explaining the reasons behind the proposed withdrawal, the statement said, "Thanks to its growing economy, India is projected to reach the threshold of $1,580 Gross National Income per capita which means it has entered what is known as the 'graduation' phase in relation to Gavi support." While making it clear that there is no rift with the government, it again mentioned the five year target. "Over the next five years, GAVI and India will work together towards financing the introductions of some new vaccines and assuring that these will ultimately have budget provisions within the government of India budget so that children in India continue to have access to vaccines for generations to come," it said. GAVI also applauded what is called the excellent work by the Government of India to improve immunization coverage under 'Mission Indradhanush' and its work to protect the lives of children living in 201 of the most at risk districts in the country. ]]> <![CDATA[FDA approval for Glenmark's generic drug]]> https://biospectrumindia.com/news/95/6178/fda-approval-for-glenmarks-generic-drug.html https://biospectrumindia.com/news/95/6178/fda-approval-for-glenmarks-generic-drug.html Fri, 29 May 2015 17:14:24 +0530 Glenmark Pharmaceuticals has said that the US Food and Drug Administration (US FDA) has approved its generic version of desmopressin acetate tablets used in the treatment of diabetes and bed-wetting. The approval is for strengths of 0.1 mg and 0.2 mg. Desmopressin acetate is sold under the trademark DDAVP by Ferring Pharmaceuticals. Accordint to IMS data, DDAVP market achieved annual sales of approximately $72.1million in the 12 month period ended March 2015. ]]> <![CDATA[Stem cell therapy to aid MS patients]]> https://biospectrumindia.com/news/95/6209/stem-cell-therapy-to-aid-ms-patients.html https://biospectrumindia.com/news/95/6209/stem-cell-therapy-to-aid-ms-patients.html Fri, 29 May 2015 16:01:08 +0530 A study that was conducted on 12 MS patients using human embryonic stem cell (hESC) therapy over two and half years has shown that all the patients suffering from irritability and vision impairment showed improvement in mood and vision post stem cell therapy. Almost 91.6 percent of patients had difficulty in walking with 45.45% showing improvement. 83.3 percent suffered from excessive fatigue. This reduced in all the patients with 40 percent becoming normal. The study of human embryonic stem cells is promising but no hospital specializes in such treatment. Nutech Mediworld is the only centre in India and the world offering hESC. Located in the heart of New Delhi, it attracts hundreds of patients suffering from many incurable diseases from across the world such as UK, USA and Europe. Embryonic stem cells are conventionally derived from the inner cell mass of the blastocyst. They are cultured in the laboratory and have been shown to regenerate tissue. Recently, USA approved a few FDA approved clinical trials. ]]> <![CDATA[Syngenta, Bayer, Dow, and BASF retain leadership in global crop protection chemicals market]]> https://biospectrumindia.com/features/95/8046/syngenta-bayer-dow-and-basf-retain-leadership-in-global-crop-protection-chemicals-market.html https://biospectrumindia.com/features/95/8046/syngenta-bayer-dow-and-basf-retain-leadership-in-global-crop-protection-chemicals-market.html Fri, 29 May 2015 15:52:55 +0530 According to a report published by Mordor Intelligence on crop protection chemicals, the global volume market for pesticides is projected to reach 3.4 million tons by 2020 from 2.3 million tons in 2014, with a CAGR for volume growth being 6.2 percent between 2015 and 2020. Factors driving the markets for pesticides include decreasing arable land, increasing population and the requirement of improving crop yields. On the other hand, regulatory authorities such as EPA (Environment Protection Agency) frequently come up with stringent laws related to curbing pesticide use for alleviating environmental damage and increasing consumer awareness about pesticide consumption, which is expected to be instrumental in slowing down growth in demand for synthetic pesticides. In addition, several highly toxic pesticides have either been banned or are in the process of being phased out, thereby opening new avenues for growth in demand for Biopesticides. For instance, chemicals such as glyphosate (herbicide), atrazine (herbicide) and chlorpyrifos (insecticide), to name a few, remain under constant reviews and can be either gradually phased out or even banned if more eco-friendly options are made available. Being organic, free of chemical residues and eco-friendly products, Biopesticides have been witnessing faster growth in demand compared to their synthetic counterparts. Governments in several countries have come up with initiatives aimed at promoting the development and use of Biopesticides because of their low toxicity, greater safety and higher effectiveness in controlling pests. However, growth in the market has also been hampered due to the entrenched pesticides market, low per capita usage of pesticides in several regions, shrinking farm lands, and burgeoning research and development costs. Despite being the largest market for Pesticides, demand growth in North America is likely to be the slowest, while Asia-Pacific is expected to emerge as the fastest growing market. Asia-Pacific is forecast to be the fastest growing, with a 2015-2020 volume CAGR of 7.9 percent. US, China, Japan and Taiwan have the highest per capita (Kg/ha) usage of pesticides when compared to low consumption in countries like India, Greece among others. However, the need for food security and better reforms will drive the market in these countries. ]]> <![CDATA[Pfizer's rare lung disease drug approved]]> https://biospectrumindia.com/news/95/4242/pfizers-rare-lung-disease-drug-approved.html https://biospectrumindia.com/news/95/4242/pfizers-rare-lung-disease-drug-approved.html Fri, 29 May 2015 15:52:10 +0530 In what is being lauded as one of the fastest decisions by the regulatory body, the USFDA has approved Pfizer's a rare, progressive lung disease drug. Rapamune or Sirolimus, as it is chemically known, heads the product pipeline for Pfizer. It treats lymphangioleiomyomatosis (LAM), a deadly disease that causes damage to the lungs and affects only two to five women of childbearing age in the entire population. Rapamune is the first drug to be approved for this disease. The drug underwent safety and efficacy tests in a clinical trial on 89 patients over a 24 month period. A 12 month treatment period followed by an observation period of the same length. The drug was approved originally approved in 1999 as an immunosuppressive agent. As it was found to offer better treatment results over others, it was designated a breakthrough therapy. It also received an orphan drug designation because of the rarity of LAM. ]]> <![CDATA[Cancer second largest killer in India: Oncology report]]> https://biospectrumindia.com/news/95/7321/cancer-second-largest-killer-in-india-oncology-report.html https://biospectrumindia.com/news/95/7321/cancer-second-largest-killer-in-india-oncology-report.html Fri, 29 May 2015 15:45:06 +0530 Cancer kills the most number of people in India after heart disease, says Global Burden of Cancer report 2013 published by JAMA Oncology. According to the report, there were 1.17 million new cancer cases in India whereas 6,75,000 deaths in 2013. There is a sharp increase from the figures from 1990 when the numbers registered were 6,24,000 cancer cases and 4,26,000 deaths. Late diagnosis of cancer in advanced stages leads to late treatment, causing more deaths in India. In 2013 there were 14.9 million incident cancer cases, 8.2 million deaths, and 196.3 million DALYs. Prostate cancer was the leading cause for cancer incidence (1.4 million) for men and breast cancer for women (1.8 million). Tracheal, bronchus, and lung (TBL) cancer was the leading cause for cancer death in men and women, with 1.6 million deaths. For men, TBL cancer was the leading cause of DALYs (24.9 million). For women, breast cancer was the leading cause of DALYs (13.1 million). Age-standardized incidence rates (ASIRs) per 100â€¯000 and age-standardized death rates (ASDRs) per 100â€¯000 for both sexes in 2013 were higher in developing vs developed countries for stomach cancer (ASIR, 17 vs 14; ASDR, 15 vs 11), liver cancer (ASIR, 15 vs 7; ASDR, 16 vs 7), esophageal cancer (ASIR, 9 vs 4; ASDR, 9 vs 4), cervical cancer (ASIR, 8 vs 5; ASDR, 4 vs 2), lip and oral cavity cancer (ASIR, 7 vs 6; ASDR, 2 vs 2), and nasopharyngeal cancer (ASIR, 1.5 vs 0.4; ASDR, 1.2 vs 0.3). Between 1990 and 2013, ASIRs for all cancers combined (except nonmelanoma skin cancer and Kaposi sarcoma) increased by more than 10% in 113 countries and decreased by more than 10% in 12 of 188 countries. Cancer poses a major threat to public health worldwide, and incidence rates have increased in most countries since 1990. The trend is a particular threat to developing nations with health systems that are ill-equipped to deal with complex and expensive cancer treatments, says report. ]]> <![CDATA[NOMCoL urge for collaboration between the pharmacopeias and drug regulatory bodies]]> https://biospectrumindia.com/news/95/6763/nomcol-urge-for-collaboration-between-the-pharmacopeias-and-drug-regulatory-bodies.html https://biospectrumindia.com/news/95/6763/nomcol-urge-for-collaboration-between-the-pharmacopeias-and-drug-regulatory-bodies.html Thu, 28 May 2015 16:18:37 +0530 US Pharmacopeia (USP) organized a three-day workshop for the Asia chapter of the Network of Official Medicines Control Laboratories (NOMCoL) from May 26-28, 2015. Members of NOMCoL's Asia-Pacific chapter met on day one to discuss the need for harmonization and collaboration between the pharmacopeias and drug regulatory bodies to ensure quality, safety and efficacy of drugs. The NOMCoL Hyderabad workshop was also attended by representatives of the Central Drugs Standard Control Organization and drug and quality control officials from countries like Vietnam, Philippines, Indonesia and Laos. Discussions focused on current issues faced by the laboratories related to dissolution and HPLC (high performance liquid chromatography), Inter Laboratory Testing (ILT) results from 2014, selection of ILT sample for 2015 and proper ways to test samples from receipt to storage. The discussion also touched upon NOMCoL Asia Pacific's future sustainability plan and the strategy to enhance network operations. "Borders are porous for poor quality medicines, which present a real threat to public health. Communications across regions and a cooperative response are imperative. USP sees an opportunity to support India in a leadership role in the Asia Pacific region: helping to build laboratory capacity among other neighboring countries, enabling stronger regulatory systems, and protecting millions of patients from harm ," said Kelly Willis, Senior Vice-President - Global Public Health, US Pharmacopeia "We appreciate US Pharmacopeia's work initiated through NOMCoL and congratulate them for organizing this meeting of regulators from South-east Asia that enables collaboration with them. US Pharmacopeia's presence in India has boosted the confidence of the Indian drug manufacturers who export their medicines and vaccines and we want USP to work with us in the national quality control program. We are planning to introduce international alert and mobile testing units to maintain the quality of medicines and keep a check," said Dr. GN Singh, Drugs Controller General of India. "NOMCoL offers unique inter-laboratory testing activities for participating labs to improve laboratory performance as well as harmonize their drug analysis methodologies and help in the quality control of essential medicines, detect substandard and counterfeit drugs. As a standard setting organization and Global Public Health as our mission, we would like to promote good quality medicines across the world. NOMCol is one such initiative," said Dr. K V Surendranath, Senior Vice President, International Site Operations; Senior Vice President, USP-India NOMCoL networks have been established to provide a forum for sharing best practices and address issues surrounding quality of medicines at regional and national levels. These networks offer unique inter-laboratory testing activities for participating labs to improve laboratory performance as well as harmonize their drug analysis methodologies. There are currently four OMCL networks: The External Quality Control Programs (EQCP) network, created in collaboration with the Pan American Health Organization (PAHO) and OMCLs from Latin American and Caribbean countries (2001); and the Networks of Official Medicines Control Laboratories (NOMCoL) in Africa (2009), Middle East/North Africa (MENA) (2010), and Asia Pacific (2013). NOMCol-Asia Pacific was established in the region with the aim of strengthening the technical and procedural capacity of members to achieve and maintain international medicines control laboratory standards. ]]> <![CDATA[AstraZeneca Pharma reports Rs 21 crore loss for FY 14-15]]> https://biospectrumindia.com/news/95/4223/astrazeneca-pharma-reports-rs-21-crore-loss-for-fy-14-15.html https://biospectrumindia.com/news/95/4223/astrazeneca-pharma-reports-rs-21-crore-loss-for-fy-14-15.html Thu, 28 May 2015 12:50:00 +0530 AstraZeneca Pharma India today reported a net profit of Rs. 38.12 crore for the fourth quarter ended March 31, 2015. Net sales for the same period is at Rs 120.80 crore, while the same were at Rs 114.14 crore during the same period in the previous fiscal. For the year ended March 31, the company posted a net loss of Rs 20.83 crore, while it had reported a net loss of Rs 50.89 lakh during the previous year, AstraZeneca Pharma said in a filing to the BSE. ]]> <![CDATA[AbbVie completes the acquisition of Pharmacyclics]]> https://biospectrumindia.com/news/95/4121/abbvie-completes-the-acquisition-of-pharmacyclics.html https://biospectrumindia.com/news/95/4121/abbvie-completes-the-acquisition-of-pharmacyclics.html Thu, 28 May 2015 10:52:18 +0530 AbbVie has announced that it has completed the acquisition of Pharmacyclics. Pharmacyclics is a leader in the hematological oncology market with Imbruvica (ibrutinib), a first-in-class BTK-inhibitor used to treat hematological cancers. "The companies' shared expertise, combined with AbbVie's broad late-stage oncology pipeline, has the potential to transform the cancer treatment landscape for hematological malignancies and improve patient outcomes and quality of life," said Mr Richard A Gonzalez, chairman and chief executive officer, AbbVie. He added, "Today marks a significant step forward in our effort to become a leader in oncology and meaningfully augment our long-term growth strategy. The Pharmacyclics team has built an important and rapidly growing franchise with significant long-term potential across a range of hematological cancers." Imbruvica is approved for use in four indications in the US and is the only product to have received three Breakthrough Therapy designations by the US Food and Drug Administration (US FDA). As part of a worldwide partnership with Janssen Biotech, the drug is now approved in nearly 50 countries. It is in mid- and late-stage development for additional hematological oncology indications, with more than 60 clinical trials underway, including 13 in Phase III development. It is also in early-stage development for solid tumors. Pharmacyclics will be a wholly-owned subsidiary of AbbVie and will operate from its Sunnyvale, California headquarters. Mr Wulff-Erik von Borcke, former head of AbbVie's global marketing, will lead Pharmacyclics as president. ]]> <![CDATA[Cipla join hands with Serum]]> https://biospectrumindia.com/news/95/4124/cipla-join-hands-with-serum.html https://biospectrumindia.com/news/95/4124/cipla-join-hands-with-serum.html Thu, 28 May 2015 10:51:15 +0530 Cipla has signed an exclusive pact with Serum Institute of India (SII) to market flu vaccine, Nasovac-S, in the country. As per the agreement, SII will develop and manufacture the vaccine, and Cipla will exclusively market it in India. "We are extremely delighted to have entered into a strategic partnership with SII in India. This collaboration is aligned with our commitment to access to affordable healthcare. This partnership is a significant step towards making preventative healthcare accessible to a large number of Indians through Cipla's strong countrywide sales force," said Mr Subhanu Saxena, managing director and global chief executive officer, Cipla, in a statement. Having initiated the approval process with the European Medicines Authority for marketing the products developed and manufactured by SII, Cipla is now forging ahead looking at other markets where the company has a strong presence. ]]> <![CDATA[Indian to lead Sanofi's external affairs ]]> https://biospectrumindia.com/news/95/3919/indian-to-lead-sanofis-external-affairs-.html https://biospectrumindia.com/news/95/3919/indian-to-lead-sanofis-external-affairs-.html Wed, 27 May 2015 12:08:14 +0530 Mr Kumar joins Sanofi from Mr Oliver Wyman and will take the position of executive vice president, external affairs. In this newly created role, Mr Kumar will be responsible for defining Sanofi's vision for meeting global health challenges. This will include setting the strategy and priorities for public affairs activities, interactions with governments and international organizations - and aligning internal and external communications around these priorities. As part of bringing these activities together in a more integrated way, the communications and corporate social responsibility (CSR) teams will report to Mr. Kumar. "Suresh brings a genuinely unique profile to Sanofi that includes a diversified, international career within the healthcare industry, public sector leadership experience and an intimate understanding of NGOs," said Mr Olivier Brandicourt, CEO, Sanofi. "Suresh's deep relationships with business and government leaders worldwide and his passion for making an impact on improving lives through healthcare will make him a valuable addition to Sanofi and the executive committee." Mr Kumar has an Economics degree from Delhi University, and a Masters in Management from Bombay University. A US citizen, born and educated in India, Mr Kumar has more than 30 years of experience in the healthcare industry beginning in 1978 in India with Johnson and Johnson (J&J). ]]> <![CDATA[Cipla recalls asthma drug in the US]]> https://biospectrumindia.com/news/95/4358/cipla-recalls-asthma-drug-in-the-us.html https://biospectrumindia.com/news/95/4358/cipla-recalls-asthma-drug-in-the-us.html Wed, 27 May 2015 11:28:15 +0530 Cipla has decided to recall 1,40,625 vials of Levalbuterol Inhalation Solution from the US market. The solution is used for relieving shortness of breath and coughing caused by asthma and chronic obstructive pulmonary disease. The company is recalling the drug for failed impurities and degradation specifications, according to the information available on the USFDA website. Reportedly, the vials were manufactured by Cipla at its Pithampur manufacturing facility, near Indore, for Princeton-based Dr Reddy's Laboratories. The recall of the drugs has been initiated under Class-III which FDA defined as "a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences." ]]> <![CDATA[Cipla acquires 51% stake in Uganda-based QCL]]> https://biospectrumindia.com/news/95/4382/cipla-acquires-51-stake-in-uganda-based-qcl.html https://biospectrumindia.com/news/95/4382/cipla-acquires-51-stake-in-uganda-based-qcl.html Tue, 26 May 2015 11:52:52 +0530 Cipla has informed BSE (Bombay Stock Exchange) that Cipla (EU), UK, the wholly owned subsidiary of the company, has entered into a definitive agreement to acquire a 51 percent stake in Quality Chemicals Limited (QCL), Uganda from the existing shareholders of QCL. As per the agreement, the cash consideration for 51 percent stake is payable in tranches with approx. $8 million payable upfront on completion and 5 equal installments of $4.41 million payable at annual intervals thereafter. QCL was incorporated in the year 1997 and is engaged in the business of import and distribution of pharmaceutical and consumer products. QCL also holds a 22.05 percent stake in the company's subsidiary in Uganda, Cipla Quality Chemical Industries Limited (CQCIL). Consequent to this acquisition, company's effective stake (held through its subsidiaries) in CQCIL will increase from the existing 51.05 percent to 62.30 percent. This acquisition will further strengthen the company's overall presence in the African market. The turnover of QCL for the financial year ending Dec 2012, Dec 2013 and Dec 2014 was Ugandan Shilling 15.76 billion, Ugandan Shilling 17.02 billion and Ugandan Shilling 14.85 billion respectively. The turnover $45 bn was recorded with QCL for the fiscal year 2014-15. ]]> <![CDATA[Strides to acquire Aspen in Australia]]> https://biospectrumindia.com/news/95/7553/strides-to-acquire-aspen-in-australia.html https://biospectrumindia.com/news/95/7553/strides-to-acquire-aspen-in-australia.html Tue, 26 May 2015 11:38:38 +0530 Strides Arcolab has announced that Strides Pharma Global, Singapore and Strides Pharma, Australia, both wholly owned subsidiaries of Strides Arcolab have signed definitive agreements with certain wholly owned subsidiaries of Aspen Pharmacare Holdings, to acquire a generic pharmaceutical business in Australia together with certain branded pharmaceutical assets. The company is listed on the Johannesburg Stock Exchange (Aspen). The business and assets being acquired from Aspen have a current prescription market share that will rank Strides and its group entities as one of the top three generic pharmaceutical suppliers in Australia and among the top ten pharmaceutical companies in the Australian pharma market. The business, which will operate under the Arrow Pharmaceuticals brand, will sell approximately 140 generic prescription drugs and an extensive range of non-prescription pharmacy products. The business and the assets being acquired will give Strides group one of the largest pharmaceutical product portfolios in the Australian market. Strides' previous business in the Australian generic pharmaceutical market, Ascent Pharmahealth, was sold to Actavis in January 2012 after a successful 5-year investment and growth strategy. The new Arrow Pharmaceuticals business will be led by Dennis Bastas, the previous founder and CEO of Ascent Pharmahealth. "The Australian generic pharmaceutical market has always been very successful for Strides. The Aspen Australian generic pharmaceutical assets are a valuable and unique platform for Strides to re-build its business in Australia. Strong local management, a market leading product portfolio supported by our in-house cost effective manufacturing, will be the key ingredients of our strategy for Australia," said Mr Arun Kumar, founder and Group CEO of Strides Arcolab. The acquired products had sales of approximately A$120 million in the past financial year (June 2014) with an EBITDA margin of approximately 31 percent. The consideration for the acquisitions will be approximately A$380 million(approx. $297 million). The acquisition of the business will include access to the product pipeline that was under development by Aspen and includes a number of major product launches in the next six months. The transactions will be financed by a combination of internal accruals and debt financing. It will be EPS accretive immediately. The transactions are expected to close by the end of Q2 FY16 subject to customary closing conditions and regulatory approvals. ]]> <![CDATA[Pfizer eying GSK for $146 bn deal]]> https://biospectrumindia.com/news/95/4466/pfizer-eying-gsk-for-146-bn-deal.html https://biospectrumindia.com/news/95/4466/pfizer-eying-gsk-for-146-bn-deal.html Tue, 26 May 2015 10:28:12 +0530 Pfizer is said to be bidding for GSK at a whopping $146 billion. Analysts at Deutsch Bank wrote a note introducing 'PfizerKline': "Pfizer's shareholder-friendly management team has previously stated that the company is open to acquisitions of various shapes and sizes. Regardless of whether Pfizer decides to split the company into pieces at some point, we believe that the company has a sense of urgency to create value by leveraging the power of its balance sheet to do needle-moving deals. As evidenced by Pfizer's interest in AstraZeneca last year, one important goal for Pfizer has been to seek a deal that would maximize access to its balance sheet and improve its tax structure. "Since media reports in the past have pointed to the potential for a Pfizer/GlaxoSmithKline combination, we are revisiting that theme and presenting a pro forma analysis of this potential combo. In short, this potential combination could be materially accretive to earnings per share and discounted cashflow, while allowing Pfizer to unlock access to its balance sheet and improve its tax situation over time. "As a base case, we assumed a purchase price of £1924 a share [around $146bn or £95bn in total] funded with half stock/half cash, cost synergies of around $3.7bn, and a simple blend of tax rates." ]]> <![CDATA[FDA nod for Aurobindo's Sildenafil injection]]> https://biospectrumindia.com/news/95/3890/fda-nod-for-aurobindos-sildenafil-injection.html https://biospectrumindia.com/news/95/3890/fda-nod-for-aurobindos-sildenafil-injection.html Mon, 25 May 2015 16:10:52 +0530 Aurobindo Pharma has announced that it has received approval from the US Food and Drug Administration ( US FDA) to manufacture and market Sildenafil injection. Sildenafil injection is a generic version of Pfizer's Revatio injection. The injection is indicated for the treatment of adult patients with pulmonary arterial hypertension who are temporarily unable to take oral therapy, but are otherwise clinically and haemodynamically stable. ]]> <![CDATA[Boehringer inks oncology pact with Eureka ]]> https://biospectrumindia.com/news/95/4471/boehringer-inks-oncology-pact-with-eureka-.html https://biospectrumindia.com/news/95/4471/boehringer-inks-oncology-pact-with-eureka-.html Mon, 25 May 2015 16:10:06 +0530 Eureka Therapeutics and Boehringer Ingelheim has announced that they have entered into a research agreement for the discovery of novel therapeutic antibodies in oncology. Eureka Therapeutics will apply its proprietary human sequence antibody libraries and its unique technology platform to identify antibodies recognizing intracellular proteins, which represent approximately 90 percent of cancer-specific targets. Cancer-specific peptides that can be displayed via the MHC-complex (major histocompatibility complex) on the cell surface will be selected by Boehringer Ingelheim to develop better therapies for cancer patients, for whom treatment options are inadequate or non-existent. Boehringer Ingelheim will have the option to conduct further development and commercialization of the antibodies. Under the terms of the agreement, Eureka Therapeutics will receive an undisclosed upfront technology access fee and research funding for each program, and may receive technical success fees, option exercise fees, and other downstream payments. "We are excited to partner with Boehringer Ingelheim, a leader in oncology research and development to develop next generation cancer immunotherapies targeting intracellular oncogenes," said Dr Cheng Liu, president and CEO, Eureka Therapeutics. He added, "Intracellular oncogenes represent 90 percent of cancer-specific antigens, many of which were considered "undruggable targets" until recently. This collaboration builds upon Eureka's success in discovery and development of fully human antibodies against intracellular oncogenes. We look forward to working with Boehringer Ingelheim to advance the immuno-oncology frontier and address some of the most challenging unmet medical needs." "This collaboration underlines our long-term commitment to oncology and our interest in exploring new target spaces with antibodies that recognize intracellular proteins. It will open up entirely new opportunities for the development of tumor cell- as well as immune cell-targeted therapies. We are looking forward to working closely with Eureka´s scientists to develop novel, effective therapies targeting cancers that have proved particularly difficult to treat in the past," said Dr Michel Pairet, senior corporate vice-president of Research and Non-clinical Development at Boehringer Ingelheim. ]]> <![CDATA[Alfa Corpuscles develops indigenous yet affordable key surgical technology ]]> https://biospectrumindia.com/news/95/6564/alfa-corpuscles-develops-indigenous-yet-affordable-key-surgical-technology-.html https://biospectrumindia.com/news/95/6564/alfa-corpuscles-develops-indigenous-yet-affordable-key-surgical-technology-.html Mon, 25 May 2015 10:39:25 +0530 The most critical component of any laparoscopic surgery is the trocar, which is used to gain access to the abdomen for inserting the laparoscope and surgical instruments. To address to the risk of infections and injury due to the reuse of trocars, increasing number of surgeons prefer using disposable trocars, but high cost of the imported products leads to the malpractice of reuse of single use devices. But now the New Delhi based Alfa Corpuscles, with financial assistance from the Technology Development Board, has commercialized endoXS, the First Indigenously designed 'Disposable Trocar for Laparoscopy' that has been developed from inputs from over 150 Surgeons, conforms to all international standards and has innovative features that leads to significant cost reduction. The product is manufactured in a GMP Facility, has a CE marked and has an ISO 13485 and CMDCAS Certification and bears Indian Patent Application Number 2032/DEL/2014. Unique Features of endoXS are 'bladeless separator tip' for access with minimal tissue damage, 'angulated fascial thread' for superior abdominal wall retention, 'inbuilt adaptive flexi-seal' to maintain abdominal insufflations while accommodating a wide range of instrument sizes (4.7mm to 12.9mm) and 'optical access technology', enhancing safety during insertion by enabling visualization of the tissue layers. "The sales of endoXSTM have already been promising with a lot of surgeons expressing interest and acknowledging the ease of operation with the device. With the introduction, widespread use and disposal of low cost disposable trocars such as endoXSTM there shall be a reduction in overall cost of laparoscopic surgery, reduced incidents of injury or infection due to reuse and adherence of ethical practices in relation to the device by doctors and hospitals," mentioned the company's spokesperson. On what lies ahead, he added further, "Keeping up the spirit of Make in India campaign and with the positive encouragement of the Indian Government, we hope our product, endoXSTM, would be readily taken up by various hospitals and clinical institutions, and appreciated for its low cost and quality which is at par with various imported products presently in the market." The company believes that in the coming years, with the availability of endoXSTM, there would be reduction in overall cost of laparoscopic surgery, reduced incidents of injury or infection due to reuse and adoption of ethical practices of disposing single use devices by doctors and hospitals. Minimal Access (Laparoscopic) Surgery has come to be the mainstay treatment for a majority of surgically correctable diseases. One of the most critical components of any laparoscopic surgery is the trocar. Trocars injuries and infections can prove disastrous to the patient's health and surgeons repute. The currently available forms of the trocars are either metallic (reusable) or plastic (disposable). The metallic trocars are capital intensive, require frequent servicing, sharpening and are more prone to causing injury (both mechanical and electrical). Also, being complex lumened (hollow) devices are difficult to clean and nearly impossible to sterilise with conventional methods such as autoclave. Heating of water to produce steam in autoclave also releases the dissolved air giving rise to a noncondensable gas fraction. The plastic (disposable) trocars, are marked for single use, which are expensive, hence they are frequently reused to justify or recover cost. These are usually subject to formalin vapour or gluteraldehyde (QAC) exposure, but due to the inaccessible inner chambers cannot be cleaned or sterilised effectively and reprocessing of single use devices stays as an issue of debate. Larger centres often use ethylene oxide or sterrad for reprocessing of single use devices but pay little heed to validation of sterilisation and material disintegration that often leads to device failure and patient harm. The disposable trocar has clear advantage both in terms of features and safety over the metallic and the use of such as a single use device is both safe and ethically correct, but the medical device industry needs to effectively design and produce low cost products to encourage disposal after use. ]]> <![CDATA[Srinagar hosts event on International Biodiversity Day ]]> https://biospectrumindia.com/news/95/3926/srinagar-hosts-event-on-international-biodiversity-day-.html https://biospectrumindia.com/news/95/3926/srinagar-hosts-event-on-international-biodiversity-day-.html Fri, 22 May 2015 13:46:13 +0530 The International Day for Biological Diversity is being celebrated is being celebrated all over the country by different states and organizations on May, 22. The main event is being held in Srinagar, Jammu and Kashmir. The celebration is to recognize the pivotal role of biodiversity to life on earth and human well-being, as well as to increase awareness of the importance of biodiversity and the threats to it. It was on this day in 1992 that the text of the Convention of Biodiversity was adopted. This year's theme is 'Biodiversity for Sustainable Development'. In this event, the BIOFIN India project is being formally launched today with the release of a brochure. Another brochure on announcement of India Biodiversity Awards 2016, the third in the series is being released today, along with a release of a publication on good models of biodiversity governance emanating from India Biodiversity Awards 2014. Also being released today is an India Business and Biodiversity Initiative publication on best practices on biodiversity management by some companies. In his message, the environment minister, Mr Prakash Javadekar highlighted the India's strength in biodiversity. "Nature has generously endowed our country. With only 2.4 percent of the world's land area, India has 7-8 percent of the recorded species of the world, with over 46,000 species of plants and 91,000 species of animals. India is also an acknowledged centre of crop diversity, and harbours many wild and domesticated animals, fish and millions of microbes and insects. The ecosystem diversity is also unparalleled. These are the strengths to draw upon to meet the goals of ending poverty and hunger; achieving food security and improved nutrition and promoting sustainable agriculture; ensuring healthy lives and promoting well-being for all at all ages; ensuring availability and sustainable management of water and sanitation for all and in making cities and human settlements inclusive, safe, resilient and sustainable. Promoting multiple varieties of staple foodgrains; switching to cropping patterns, wider seed and plant variety choices, water conservation and utilisation patterns, and farming practices that combine the best of traditional wisdom and science with a whole-system perspective; valuing the therapeutic properties and medicinal uses of various parts of plants and animals; all form key aspects of the way ahead." ]]> <![CDATA[Biodiversity conservation & sustainable development must go hand in hand says Javadekar]]> https://biospectrumindia.com/news/95/3933/biodiversity-conservation-sustainable-development-must-go-hand-in-hand-says-javadekar.html https://biospectrumindia.com/news/95/3933/biodiversity-conservation-sustainable-development-must-go-hand-in-hand-says-javadekar.html Fri, 22 May 2015 12:17:38 +0530 The Minister of State (Independent Charge) of Environment, Forest and Climate Change, Mr Prakash Javadekar, has emphasised the need to work together to conserve biodiversity to ensure the future for the present generation and the coming generations. In his message on International Day for Biological Diversity being celebrated today, Mr Javadekar said that this earth has been borrowed from children and not inherited from ancestors. The minister said that the imperative challenge before India is to imbibe and translate the theme of Biodiversity for Sustainable Development, due to its privileged status as a megabiodiverse country, past and projected demographic transitions and commitment to democracy as a political principle. Explaining this in detail, the minister mentioned, "Today we celebrate the International Day for Biological Diversity, to recognise the pivotal role of biodiversity to life on earth and human well-being. On this day in 1992, the text of the Convention on Biological Diversity (CBD) was adopted. To mark this, 22nd May has been proclaimed by the United Nations as the International Day for Biological Diversity, to increase awareness about the importance of and threats to biodiversity." "The theme this year, 'Biodiversity for Sustainable Development' is very topical, as the international community accelerates its efforts to define the post-2015 agenda, including adopting a set of goals for sustainable development. This year's theme reflects the bigger and very crucial paradigm shift that the world has undergone from seeing 'development' and 'environment' as two ends of a spectrum, where one must be compromised in order to enhance the other, to having development while protecting environment," said Mr Javadekar, "The challenge before India to imbibe and translate the theme of 'Biodiversity for Sustainable Development' is imperative in the light of our privileged status as a megabiodiverse country, past and projected demographic transitions and commitment to democracy as a political principle. These three facets make it non-negotiable that we galvanise the political will, scientific and technological know-how and financial resources to contribute to the agenda set out in the outcome document from the Rio+20 Conference, 'The future we want'." ]]> <![CDATA[Serum may acquire Cipla: Report]]> https://biospectrumindia.com/news/95/4453/serum-may-acquire-cipla-report.html https://biospectrumindia.com/news/95/4453/serum-may-acquire-cipla-report.html Fri, 22 May 2015 12:09:59 +0530 Serum Institute of India will look at a possible merger with the generic drug maker Cipla, if the European venture between the two companies succeeds, as per a report in Live Mint. The companies had earlier signed a distribution agreement for affordable pediatric vaccines in Europe. The report quoted Mr Cyrus Poonawalla, chairman, Serum, "If it's successful, then the merger makes sense, because then we'd be selling as well as manufacturing here, so it'd make a lot of sense. We won't want to make a merger which could end up into nothing." ]]> <![CDATA[Janssen buys autoimmune licence from Novo Nordisk ]]> https://biospectrumindia.com/news/95/6465/janssen-buys-autoimmune-licence-from-novo-nordisk-.html https://biospectrumindia.com/news/95/6465/janssen-buys-autoimmune-licence-from-novo-nordisk-.html Fri, 22 May 2015 12:09:28 +0530 Novo Nordisk A/S has signed an agreement with Janssen Biotech (Janssen) under which Janssen will acquire an exclusive global licence to further develop and commercialise a clinical programme focused on therapy within autoimmune diseases. The programme targets modulation of certain immune cells via a cell surface receptor (NKG2D receptor). Terms of the agreement have not been disclosed. The agreement is subject to final clearance under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (HSR) with the US Department of Justice Antitrust Division and the Federal Trade Commission. ]]> <![CDATA[Cadila plans to acquire Claris Life Sciences: Report]]> https://biospectrumindia.com/news/95/6616/cadila-plans-to-acquire-claris-life-sciences-report.html https://biospectrumindia.com/news/95/6616/cadila-plans-to-acquire-claris-life-sciences-report.html Thu, 21 May 2015 13:24:24 +0530 Cadila Healthcare to acquire the generic sterile injectables business of Claris Lifesciences, says a report in Economic Times. Claris Lifesciences is an Ahmedabad-based company dealing in Specialty Injectables business. Both the companies are currently engaged in the last minute negotiations. As per the report, "Cadila is likely to pay a significant premium, valuing the company between Rs 3100 crore - Rs 3400 crore. For 12 months ending December 3,1 2104, the injectables business reported revenues of Rs 405.6 crore and EBITDA of Rs 149.4 crore (37 percent EBITDA margin). Therefore the business is getting valued at over 22 times EV/EBITDA. To put it in perspective the current market cap of parent Claris Lifesciences including all the different businesses is Rs 1793 crore." The report further stated that a formal announcement is expected early next month if everything goes well. ]]> <![CDATA[Glenmark's Rufinamide Tablets receive FDA approval]]> https://biospectrumindia.com/news/95/6334/glenmarks-rufinamide-tablets-receive-fda-approval.html https://biospectrumindia.com/news/95/6334/glenmarks-rufinamide-tablets-receive-fda-approval.html Thu, 21 May 2015 12:55:16 +0530 Glenmark Pharmaceuticals has been granted tentative approval by the United States Food and Drug Administration (US FDA) for its Rufinamide Tablets USP, 200 mg and 400 mg. The drug is used to treat seizures caused by the Lennox-Gastaut syndrome. It is a therapeutic equivalent of Banzel Tablets, manufactured by Eisai. Under the terms of a settlement agreement between Glenmark and Eisai, Glenmark will be permitted to market this product in the United States on May 30, 2022 or potentially earlier under certain circumstances. According to IMS Health sales data for the 12 month period ending March 2015, the Banzel market achieved annual sales of approximately $121.8 million. ]]> <![CDATA['Promising malaria, dengue vaccines alone will not defeat diseases']]> https://biospectrumindia.com/features/95/6297/promising-malaria-dengue-vaccines-alone-will-not-defeat-diseases.html https://biospectrumindia.com/features/95/6297/promising-malaria-dengue-vaccines-alone-will-not-defeat-diseases.html Thu, 21 May 2015 12:38:44 +0530 Despite the optimism surrounding two first-in-class products, Sanofi Pasteur's live-attenuated dengue vaccine, CYD-TDV, and GlaxoSmithKline's (GSK's) adjuvanted subunit malaria vaccine, RTS,S/AS01, vaccination alone is not a viable long-term solution for combatting these infectious diseases, says an analyst with research and consulting firm GlobalData. According to Dr Christopher J Pace, GlobalData's managing analyst covering Infectious diseases, some industry pundits rightfully question the modest protective efficacies of CYD-TDV and RTS,S/AS01. Immunization must therefore be leveraged alongside vector control strategies, national and international surveillance programs, and public awareness campaigns as part of integrated disease prevention and control initiatives. Dr Pace explained: "Upon their anticipated approvals in late 2015, both Sanofi Pasteur's CYD-TDV and GSK's RTS,S/AS01 have the potential to begin providing long-awaited relief to billions of people living under the constant threat of dengue and malaria. At the very least, they represent landmark advances in the development of vaccines against these serious arthropod-borne illnesses. "Nevertheless, we expect that while vaccines will be an essential component of future dengue and malaria prevention and control efforts, immunization cannot succeed as a 'silver bullet' solution for either disease." The analyst added that renewed vector control efforts, from established methods such as mosquito nets and insecticides, to emerging microbiological and genetic techniques, are especially important to curtailing dengue and malaria transmission. Dr Pace continued: "There are a number of novel tools on the horizon that will complement vaccines, most notably improved insecticides and innovative microbiological (Walbachia, Chromobacterium [Csp_P]) and genetic (sterile male) vector control technologies, as well as more potent antivirals for dengue and antiparisitics for malaria." Ultimately, GSK and Sanofi Pasteur must work with other stakeholders to champion innovative pricing strategies and encourage vaccine uptake as part of integrated surveillance, prevention, and control programs to maximize each product's public health benefit and commercial potential. ]]> <![CDATA[Chennai gets new Stem Cell Registry]]> https://biospectrumindia.com/news/95/4100/chennai-gets-new-stem-cell-registry.html https://biospectrumindia.com/news/95/4100/chennai-gets-new-stem-cell-registry.html Thu, 21 May 2015 10:54:46 +0530 In a bid to help Indians with blood cancers, Thalassemia, Sickle Cell Disease and other curable blood disorders, Chennai-based Jeevan Blood Bank and Research Centre has launched Jeevan Stem Cell Registry. Jeevan claims to have a track record of establishing sustainable social impact projects with the support of the community and corporate houses. Jeevan established a blood bank in 1995, a Public Cord Blood Bank in 2005, a high resolution HLA typing laboratory in 2013 and now the blood bank has launched a registry of peripheral blood stem cell donors (traditionally known as bone marrow donor registry). Transplantation of stem cells from donated cord blood or from bone marrow donors offer 60 to 80% chance of cure for some blood disorders like Thalassemia, blood cancers and immune disorders. However, only 30% of these patients are able to find a match within the family. Donated cord blood can be the solution for children. Others need to search for donors in the community. Committed bone marrow donors remain the only hope for adult patients. Despite a match, several still die without transplant because of the high cost of the matching stem cell unit. Jeevan will recruit 50,000 bone marrow donors from across India over the next 5 years or earlier. These potential donors will be in the age group of 20 and 40 and from a pool of voluntary blood donors from across India. To qualify, they should have donated blood or platelets twice in the previous two years. For this, Jeevan will be working with blood banks and blood donor organisations across India. The cost of high resolution Human Leucocyte Antigen (HLA) typing for the first 6000 donors is being funded through a grant from Jamsetji Tata Trust. Jeevan hopes to raise funds for this project from the corporates under the CSR programme and through tax exempted public donations. The project cost could come down by 30%, if the Government of India decides to waive the customs duty on the reagents and the Government of Tamil Nadu considers waiving the VAT. Even though the stem cell donation is voluntary, it will cost approximately Rs. 3 lakhs for the process of collecting, testing and transporting the stem cells to the transplant centre within India. For the patient, stem cells will be made available on a cost recovery basis. The cost is expected to be less than Rs. 3 Lakhs as against the prevailing cost of Rs.8 Lakhs (Indian Registries) to 25 Lakhs (international registries). Commenting on the launch, Dr P Srinivasan, Co-Founder & Chairman of Jeevan Blood Bank and Research Centre, said, "Unlike other registries (i.e. by sending DNA samples to USA), Jeevan has established its own High Resolution HLA laboratory at a cost of 2 crores. The founders bring in their experience of running a pathology laboratory for over 20 years." He further added, "Major challenges will come up once you find a matching donor who registered to give stem cells. Universal experience is that 9 out of 10 will back-out. Hence sustained commitment of the 'potential donor' is the key factor for success. To address this, Jeevan will only be recruiting blood/platelet donors who have donated at-least twice in the past two years. These donors know about altruism and have the desire to save lives. Moreover, repeat blood donors are considered to be safe." "However the cost of stem cells from a matching donor still remains the first obstacle. For example, one of the registries in India apparently charges 8 to 10 lakhs and a unit from any international registries will cost 15 to 25 lakhs. Jeevan's philosophy is quick and affordable access. We believe that it should not cost more than 2.5 lakhs to harvest, test, HLA type and transport the stem cells from an altruistic donor. Hence Jeevan's commitment is to keep it under 3 Lakhs," commented Dr Srinivasan. ]]> <![CDATA[Despite delays, IAVI keeps its AIDS vaccine hope alive]]> https://biospectrumindia.com/news/95/5714/despite-delays-iavi-keeps-its-aids-vaccine-hope-alive.html https://biospectrumindia.com/news/95/5714/despite-delays-iavi-keeps-its-aids-vaccine-hope-alive.html Wed, 20 May 2015 16:49:50 +0530 The major advances in treatment and prevention haven't prevented the 2.1 million people contracting HIV while 1.5 million people died of AIDS-related causes in 2013. Infection rates continue to rise in specific regions and populations, three of five people living with HIV are not accessing antiretroviral therapy, and more than half of people living with HIV worldwide still don't know they have it. Even with maximized existing treatment and prevention options, models foresee hundreds of thousands of new infections per year in low- and middle-income countries in the decades to come. A vaccine will be needed to fully and sustainably stop new HIV infections. The IAVI data suggests that an effectively rolled-out vaccine that provides 70 percent protection could reduce new infections by 40 percent in its first decade and by almost half in 25 years-up to 42 million infections averted by 2070, depending on the success of other HIV/AIDS interventions. Dr Rajat Goyal, Country Director, IAVI mentioned, "In the last 30 years, HIV/AIDS has silently spread its tentacles claiming over 30 million lives worldwide and India alone is the home to the world's third largest population living with the disease. While the Government of India's sustained efforts have played a critical role in decreasing new infections by more than 55 percent over the last decade, HIV/AIDS continues its devastating march. Historically, the world has been able to conquer life threatening diseases through scientific innovation; one such major success being vaccines. Recognizing the power of this most effective public health weapon, IAVI has been working with the Government of India and across the globe to find a permanent solution to HIV through development of an AIDS vaccine." Sharing his experiences and hope, Dr Goyal says, "As a medical doctor, working in the niche field of AIDS vaccine research, it is heartening to state that our collaborative efforts have resulted in significant scientific progress that shows evidence that a vaccine to end the disease is possible. Today, Indian and global scientific researchers in addition to the sustained governmental support, need closer engagement of the industry and innovative think tanks who are today's global citizens, to collaborate and accelerate science towards making this dream of a world free of HIV, a reality." ]]> <![CDATA[Global Dyslipidemia treatment market value will approach $38 bn by 2023]]> https://biospectrumindia.com/features/95/5450/global-dyslipidemia-treatment-market-value-will-approach-38-bn-by-2023.html https://biospectrumindia.com/features/95/5450/global-dyslipidemia-treatment-market-value-will-approach-38-bn-by-2023.html Wed, 20 May 2015 15:18:09 +0530 The company's latest report states that the impressive increase, which will occur across the eight major markets (8MM) of the US, France, Germany, Italy, Spain, UK, Japan, and China, will be driven by the launch of several drugs with blockbuster potential, which are currently in late-stage development, during the forecast period. Dr Valentina Gburcik, GlobalData's director of cardiovascular & metabolic disorders, says two major revenue-generating events are expected to boost market growth, namely the launches of proprotein convertase subtilisin/kexin type 9 (PCSK9) inhibitors, from 2015, and cholesteryl ester transfer protein (CETP) inhibitors, from 2017. She explains: "Both drug classes will serve niche patient subpopulations within the low-density lipoprotein cholesterol-reducing dyslipidemia treatment space. They will be forced to compete not only with each other, but with established therapies. "These treatments' exploitation of novel mechanisms of action will give them an edge in achieving success towards this end. Ultimately, however, the drugs will need to perform successfully in major phase III cardiovascular outcomes trials if they hope to gain acceptance into the broader dyslipidemia treatment space." GlobalData expects that the major players in the PCSK9 space will be Amgen, Sanofi, Regeneron, and Pfizer. Dr Gburcik continues, "In 2016, the last major branded statin, AstraZeneca's Crestor (rosuvastatin), is anticipated to face generic competition for the first time, joining the ranks of the historical statin blockbusters, Merck's Zocor (simvastatin) and Pfizer's Lipitor (atorvastatin). In the CETP inhibitor market, Eli Lilly, Merck and possibly Dezima Pharma will be the dominant players. However, these companies' new treatments will not spell the end of the current standard of care. "On the whole, we expect that statins will remain the undisputed first-line treatment for almost all forms of dyslipidemia. However, the genericization of the statin class will serve to upend the sales landscape to 2023 and beyond," she concludes. ]]> <![CDATA[FDA approval for J&J's Schizophrenia drug ]]> https://biospectrumindia.com/news/95/5315/fda-approval-for-jjs-schizophrenia-drug-.html https://biospectrumindia.com/news/95/5315/fda-approval-for-jjs-schizophrenia-drug-.html Wed, 20 May 2015 15:17:30 +0530 Janssen Pharmaceuticals (a pharmaceutical subsidiary of Johnson & Johnson) has announced that the US Food and Drug Administration (US FDA) approved under priority review the New Drug Application (NDA) for the three-month long-acting atypical antipsychotic INVEGA TRINZA. INVEGA TRINZA, a three-month injection, is an atypical antipsychotic indicated to treat schizophrenia. Before starting INVEGA TRINZA, patients must be adequately treated with INVEGA SUSTENNA (one-month paliperidone palmitate) for at least four months. In a long-term maintenance trial, 93 percent of patients treated with INVEGA TRINZA did not experience a significant return of schizophrenia symptoms. The results of the phase III study were published in March by JAMA Psychiatry, a peer-reviewed medical journal published by the American Medical Association. Based on positive efficacy, Janssen concluded this study early following the recommendation of an Independent Data Monitoring Committee (IDMC). "With a dosing interval that can be measured in seasons, not days, people living with schizophrenia and their treatment teams can focus on recovery goals beyond short-term symptom control," said trial investigator Dr Joseph Kwentus, Precise Research Centers. He added, "Recovery looks different for everyone, and the long-term symptom control offered by INVEGA TRINZA can help patients work toward their own personal goals." "Building on Janssen's more than 50 years of leadership in developing innovative mental health therapies and helpful programs, this medication offers a new paradigm for treating people living with schizophrenia. After at least four months on INVEGA SUSTENNA, patients and their doctors can seamlessly transition to INVEGA TRINZA for sustained symptom control with a single dose every three months," said Dr Husseini Manji, Global head, Neuroscience Therapeutic Area, Janssen Research and Development. Janssen anticipates that INVEGA TRINZA will be commercially available by mid-June. Based on the phase III study, the safety and tolerability profile of INVEGA TRINZA is consistent with that of INVEGA SUSTENNA. No new benefit-risk concerns emerged from studies of INVEGA TRINZA. ]]> <![CDATA[ICAR scientists win DBT's annual product commercialization award]]> https://biospectrumindia.com/news/95/3432/icar-scientists-win-dbts-annual-product-commercialization-award.html https://biospectrumindia.com/news/95/3432/icar-scientists-win-dbts-annual-product-commercialization-award.html Wed, 20 May 2015 13:14:13 +0530 The award constituted by the department of biotechnology (DBT) on behalf of ministry of science and technology, government of India was bestowed recently to two agriculture scientists. The "Biotech Product And Process Development And Commercialization Award 2015" was jointly given to Dr Vineet Kumar & Dr Anita Rani, both Principal Scientists at ICAR-Directorate of Soybean Research, Indore in recognition of their pioneering work on development of specialty soybean seeds to meet the challenges of soya food and edible oil sector. The awards were confered by the union science and technology minister, Dr Harsh Vardhan on Technology Day Function celebrated on May 11, 2015 at Vigyan Bhawan, New Delhi. ]]> <![CDATA[Muscular dystrophy treatment pipeline offers hope ]]> https://biospectrumindia.com/features/95/6719/muscular-dystrophy-treatment-pipeline-offers-hope-.html https://biospectrumindia.com/features/95/6719/muscular-dystrophy-treatment-pipeline-offers-hope-.html Tue, 19 May 2015 12:59:37 +0530 The highly diverse and innovative pipeline for Duchenne Muscular Dystrophy (DMD) and Becker Muscular Dystrophy (BMD) treatment has the potential to produce therapies that will help repair the mutated gene, halt muscle degeneration, and improve patients' life expectancy. This exceptional level of innovation is largely due to the high number of first-in-class products that solely target the dystrophin gene, which is the primary genetic cause of DMD and BMD. According to Ms Angel Wong, senior analyst, GBI Research, the pipeline offers hope of improved treatment options for a condition that has no cure available at present, as the current DMD and BMD treatment space is extremely sparse and largely symptomatic, with limited long-term benefits. Ms Wong explained: "Over the last few decades, the market landscape has relied on the use of glucocorticoids, which offer symptomatic benefits in increasing muscle strength and a delay in the loss of ambulation in DMD/BMD patients, without altering the genetic cause and dystrophic pathology. "Translarna (ataluren), despite being the first approved therapy for treating the underlying genetic cause in the EU, is only applicable in 10-15 percent of all DMD cases, leaving other patient segments with high unmet needs." However, the DMD and BMD pipeline consists of 84 molecules across all stages of development. GBI says that it has identified 46 first-in-class programs in active development, acting on 13 first-in-class targets. Ms Wong continued: "Overall, the DMD/BMD pipeline is very diverse in terms of molecular targets. Apart from the technologies that directly target the dystrophin gene, the pipeline also contains novel targets that alleviate the dystrophic pathology regardless of gene mutations. These targets include some dystrophin-associated proteins, which have the potential to functionally compensate for its loss and are therefore intended to treat the whole patient population. "The diversity of molecular targets across the developmental pipeline presents a dramatic contrast to the current DMD therapeutics market landscape, and is expected to transform the market by fragmenting the current treatment algorithm," the analyst concluded. ]]> <![CDATA[Dr Harsh Vardhan inaugurates bio-innovation center ]]> https://biospectrumindia.com/news/95/6775/dr-harsh-vardhan-inaugurates-bio-innovation-center-.html https://biospectrumindia.com/news/95/6775/dr-harsh-vardhan-inaugurates-bio-innovation-center-.html Tue, 19 May 2015 12:55:19 +0530 Union Minister for Science and Technology and Earth Sciences, Dr Harsh Vardhan inaugurated the first phase of the Bio-Innovation Center at the Rajiv Gandhi Center for Biotechnology (RGCB). "The bio-technology sector is growing at an annual rate of 30 percent. India is set to become home to the world's third largest set-up in this field by 2025," said Dr Vardhan while inaugurating the center. "I see ten years down the road a $100 billion industry which will be the powerhouse of not only India's pharmaceutical sector, but will also be on a global scale. At this rate of growth, it looks likely to be bigger than the domestic pharmaceutical industry," he added. The 50,000 square feet innovation center has been set up with an outlay of Rs 100 crore. ]]> <![CDATA[Endo to acquire Par Pharmaceutical]]> https://biospectrumindia.com/news/95/3385/endo-to-acquire-par-pharmaceutical.html https://biospectrumindia.com/news/95/3385/endo-to-acquire-par-pharmaceutical.html Tue, 19 May 2015 12:52:05 +0530 Endo International and Par Pharmaceutical Holdings has announced that they have entered into a definitive agreement under which Endo will acquire privately-held Par from TPG in a transaction valued at $8.05 billion, including assumption of Par debt. The combination will create a leading specialty pharmaceutical company with a generics business that is one of the industry's fastest growing and among the top five as measured by US sales. The transaction has been unanimously approved by the Boards of Directors of both the companies, and is supported by the management teams of both companies. There are no further shareholder approvals required. The purchase price will consist of approximately 18 million shares ($1.55 billion of value based on the 10-day volume weighted average share price of Endo ending on May 15, 2015) of Endo equity and $6.50 billion cash consideration to Par shareholders. Endo has secured fully committed financing from Deutsche Bank and Barclays to fund the cash consideration. Endo expects to implement a permanent capital structure to finance the transaction prior to the close that would include a combination of cash, debt and an equity offering. "Our generics business, Qualitest, continues to be an extremely attractive and effective growth driver for Endo. This transaction with Par builds upon our generics growth, adding a strong portfolio of high barrier-to-entry and attractive gross margin products while also transforming Endo, creating a powerful corporate platform for future growth and strategic M&A," said Mr Rajiv De Silva, president and CEO of Endo. He added, "We believe the acquisition of Par underscores the continued execution of Endo's value-driven M&A strategy and helps deliver on our goal of achieving double-digit revenue growth for the overall business over the long-term. We are also excited to welcome Paul Campanelli to the Endo leadership team. With more than 25 years of experience in the generics industry and nearly 15 years at Par, Paul has demonstrated a clear track record of success in innovation and strategic management in specialty generics." "This is an exciting time of growth and opportunity in the generics and specialty pharmaceutical arenas. Par Pharmaceutical is committed to significantly expanding our scope, capacity and capabilities to realize the maximum value of our rich and diversified product portfolio and R&D pipeline. We believe our combination with Endo best positions us to do so," said Mr Campanelli, CEO of Par Pharmaceutical. He added, "We share Endo's goal of developing and commercializing generic drugs in areas of greatest revenue potential, complex formulations and longer life cycles. I look forward to joining the Endo team and working together to achieve that goal." Par Pharmaceutical is a privately-held company that was acquired through a take-private transaction by an affiliate of TPG in 2012. ]]> <![CDATA[FDA approves Baxter's new manufacturing unit]]> https://biospectrumindia.com/news/95/3285/fda-approves-baxters-new-manufacturing-unit.html https://biospectrumindia.com/news/95/3285/fda-approves-baxters-new-manufacturing-unit.html Tue, 19 May 2015 12:51:28 +0530 Baxter International has announced that the US Food and Drug Administration (US FDA) has approved its supplemental drug application to establish its Sabinanigo facility in Spain, as an approved manufacturing site for 0.9 percent Sodium Chloride injection, USP, for the American market. The approval includes product presentations in 250 mL, 500 mL and 1000 mL, which Baxter has been distributing in the US to alleviate a drug shortage with the knowledge of the FDA. All three of these product presentations of 0.9 percent Sodium Chloride Injection, USP, more commonly known as saline, have been listed in drug shortage databases maintained by the FDA and the American Society of Health-System Pharmacists over the past two years. ''The approval of an additional manufacturing site for Sodium Chloride Injection in the US gives us greater flexibility to respond to market demand fluctuations and will help as we continue to meet patient and healthcare provider need for this critical product,'' said Mr Brik Eyre, president of Baxter's Hospital Products business. He added,''FDA was quick to recognize the benefit of addressing industry demand for sterile IV solutions in collaboration with companies like Baxter. This approval illustrates the strength of Baxter's global manufacturing network, as well as our commitment to meeting important healthcare needs.'' ]]> <![CDATA[1,300 Indians die of cancer every day: ICMR]]> https://biospectrumindia.com/news/95/6749/1300-indians-die-of-cancer-every-day-icmr.html https://biospectrumindia.com/news/95/6749/1300-indians-die-of-cancer-every-day-icmr.html Mon, 18 May 2015 14:51:51 +0530 Singapore: With more than 1,300 deaths reported every day, cancer in India has become one of the major causes of death. A new analysis submitted by the National Cancer Registry Program (NCRP) of the India Council of Medical Research (ICMR), estimates that cancer mortality rate in the country increased by about six percent from 2012 to 2014. Statistics showed the total of 4,91,598 people died in 2014 out of 28,20,179 cases, while in 2013 it was 4,78,180 deaths out of 29,34,314 cases, and in 2012, around 4,65,169 people lost their lives due to the disease out of 30,16,628 cases. "In India, large number of ageing population, unhealthy lifestyles and diets, use of tobacco and tobacco products, lack of diagnostic facilities, are some of the factors that have attributed to increase in the number of cancer deaths," the official said. The government has approved a scheme in the year 2013-14 to enhance the specialized consultative care for cancer and circulate the guidelines to strengthen the facilities around various states by January 2014. The second highest number of deaths occurred in the country is caused by TB with 63,265 casualties in 2011, 61,887 in 2012, and 57,095 in 2013, as per records of the Revised National Tuberculosis Control Program (RNTCP). Under the program, the government, provided cost free diagnosis and treatment facilities including anti-TB drugs to patients. "We have established designated microscopy centers for quality diagnosis of over one lakh population in the rural and urban areas and 50,000 population in the tribal, hilly and difficult areas. There are 13,000 microscopy centers in the country and more than six lakh directly observed treatment centers," the official said. Government officials said that they have started working to improve various health care services and infrastructure especially for cancer patients. ]]> <![CDATA[Fibromyalgia treatment market value to crawl to $1.9 bn by 2023]]> https://biospectrumindia.com/features/95/6651/fibromyalgia-treatment-market-value-to-crawl-to-1-9-bn-by-2023.html https://biospectrumindia.com/features/95/6651/fibromyalgia-treatment-market-value-to-crawl-to-1-9-bn-by-2023.html Mon, 18 May 2015 14:03:11 +0530 The treatment market value for fibromyalgia across the seven major markets (7MM) of the US, France, Germany, Italy, Spain, the UK, and Japan, will expand from $1.8 billion in 2013 at a tepid Compound Annual Growth Rate (CAGR) of 0.72 percent to reach $1.9 billion by 2023, according to research and consulting firm GlobalData. The company's latest report states that while this growth will be primarily driven by the potential introduction of four late-stage pipeline agents, consisting of reformulations of existing therapies and 'me-too' products, it will also be dampened by the simultaneous patent expiries of the key branded products on the market. Ms Maura Musciacco, GlobalData's director of neurology and Oohthalmology, says the US will consolidate its position as the dominant market, with the country's share increasing from 83 percent of fibromyalgia treatment sales in 2013 to 86 percent by 2023. She explains: "The US is the only country among the 7MM with three approved brands: Lyrica, Cymbalta, and Savella. Along with its higher drug prices and prescribing rates, the largest fibromyalgia population, and a greater number of pipeline products compared with the other six countries, the US holds a greater share of the fibromyalgia treatment arena. "The small range of currently available fibromyalgia therapeutics means that the market will welcome new products that can offer patients better efficacy, convenience, and safety. To date, four pipeline agents will potentially be introduced by 2023, mainly in the US." These products include two reformulations, namely Pfizer's Lyrica CR and Tonix Pharmaceutical's TNX-102 SL, and two 'me-too' products, namely Daiichi Sankyo's DS-5655 and Theravance Biopharma's TD-9855. The estimated cost of these treatments will be comparatively higher than the currently available fibromyalgia therapies and the inexpensive generic products. However, Lyrica, Cymbalta, and Savella have already or will experience generic erosion between 2013 and 2023. Generic medicines are likely to dominate sales in countries where the pipeline products are limited or not available, while markets crowded with generics will see limited sales growth for new entrants. ]]> <![CDATA[Sea6, Mahindra partner for 'Jingo']]> https://biospectrumindia.com/news/95/8039/sea6-mahindra-partner-for-jingo.html https://biospectrumindia.com/news/95/8039/sea6-mahindra-partner-for-jingo.html Mon, 18 May 2015 14:01:13 +0530 The Crop Care division of Mahindra Agri Business has signed an exclusive product licence agreement with Sea6 Energy to market and distribute its crop yield enhancement product, 'Jingo.' As per an exclusive agreement with Sea6, Mahindra will market Jingo across the country through the distribution network of its Crop Care business which has a network of over 1800 dealers across 19 states. The agreement is for an initial period of nine years. Jingo has been developed by Sea6, a Bangalore-based start-up founded in 2010 by several alumni of IIT-Madras, and is currently being incubated by the Centre for Cellular and Molecular Platforms. 'Jingo' is a technologically advanced crop yield enhancement product which aims to help farmers boost agricultural productivity in a completely safe and environmentally-friendly manner. It is the first product commercialized by the start-up. 'Jingo' will initially be made available to Indian farmers in 1 liter and 500 ml packaging and can be administered to crops in a number of ways such as through a foliar spray, fertigation / drip systems or through soil, and seed and root application. The general dose per acre is 750 ml. Speaking on the exclusive agreement, Mr Vikram Puri, vice-president, Mahindra Agri Business said, "We are delighted to partner with Sea6 Energy to market 'Jingo' across the country. At Mahindra, we have always pioneered products which aim to boost farm productivity and 'Jingo', using cutting-edge technology, has demonstrably improved agricultural output in a safe and sustainable manner. We believe 'Jingo' has a vital role to play as we constantly strive to enhance rural prosperity." Field trials of 'Jingo' have shown encouraging results when used on crops like paddy, wheat, soybean, potato and sugarcane as well as all vegetable and horticultural crops like grapes, banana, mango and citrus fruit. Further, 'Jingo' has also demonstrably improved the productivity and quality of plantation crops such as coffee, tea, pepper and cardamom. ]]> <![CDATA[SC halts Glenmark from selling copies of Merck's diabetes drugs]]> https://biospectrumindia.com/news/95/7180/sc-halts-glenmark-from-selling-copies-of-mercks-diabetes-drugs.html https://biospectrumindia.com/news/95/7180/sc-halts-glenmark-from-selling-copies-of-mercks-diabetes-drugs.html Mon, 18 May 2015 13:59:36 +0530 The SC has, however, allowed Glenmark to sell its existing stocks of these two drugs. The judgment brings a great relief to Merck after two years, when in 2013 it sued its opponent for infringing its patent on the compound sitagliptin, which is present in both the drugs. ]]> <![CDATA[India has less than 1.5% share of global clinical trials: ISCR]]> https://biospectrumindia.com/news/95/5528/india-has-less-than-1-5-share-of-global-clinical-trials-iscr.html https://biospectrumindia.com/news/95/5528/india-has-less-than-1-5-share-of-global-clinical-trials-iscr.html Mon, 18 May 2015 13:58:50 +0530 ISCR is an association of clinical research professionals that aims to build awareness of clinical research as a specialty in India. A series of workshops and seminars would be held by ISCR to highlight and celebrate the very important role patients' play in clinical trials and how their safety and welfare are a top priority for all clinical research stakeholders. Said Ms Suneela Thatte, president, ISCR, "On the International Clinical Trials Day, we acknowledge the selfless contribution of clinical trial patients in inventing new drugs and treatments. We would also like to dedicate this very important day to patients who are still waiting for new breakthroughs in medical science for a better quality of life. At less than 1.5%, the share of India in global clinical trials is very low, despite the country accounting for 17% of the world's population, and 20% of the global disease burden. We will be organizing several workshops and seminars on May 20 to deliberate upon the current environment for clinical trials in India and how clinical research stakeholders can collaborate to ensure an enabling environment for clinical research in the country." Over the last few months, several steps have been taken by Indian regulators to bring clinical research in India back on track. "We now need to restore confidence among all the stakeholders that robust and streamlined guidelines and systems are in place in the country for conducting clinical research. Thousands of patients are desperately waiting for new therapies and drugs to enter the market, and we, as clinical research professionals, have an enormous responsibility to fulfill this need. We are fully committed to working with everyone across the clinical research spectrum to create an enabling environment which encourages scientific and ethical clinical research so that patients can have better and quicker access to new treatments," she added. To create an enabling environment for clinical research by raising awareness about its role and relevance, ISCR has launched a nationwide advocacy program called NavChetana. On May 20, ISCR will be relaunching its publication called "Clinical Trials - A Guide for Participants" under the NavChetana banner. The Guide empowers patients by providing a better understanding of clinical trials so that they can make a responsible and informed decision to participate. It guides patients on questions to ask investigators before making a decision to participate in clinical trials. ISCR will also be launching an educational film on the occasion, showcasing clinical research testimonials and experiences. In addition, it will be distributing its code of conduct for clinical research in India. This 12-point, patient-centric code, applicable to all ISCR members, reinforces their commitment to ethical, scientific and regulatory compliance while engaging in any clinical research activity. Said Ms Suneela Thatte: "As a professional organization representing clinical research professionals, ISCR fully supports a more robust and regulated clinical research environment to ensure highest standards of ethics and quality and protect patient rights. We seek media support in acknowledging the role of clinical trial patients who are unsung heroes and highlighting the experience and struggles of today's patients, particularly those suffering from unmet medical needs. We need to build an environment that fosters clinical research, drug discovery and innovation through public education and awareness." ]]> <![CDATA[Dr Reddy's launches 'Somazina']]> https://biospectrumindia.com/news/95/6650/dr-reddys-launches-somazina.html https://biospectrumindia.com/news/95/6650/dr-reddys-launches-somazina.html Mon, 18 May 2015 12:56:54 +0530 Dr Reddy's Laboratories has announced the launch of Somazina, the innovator brand of Citicoline in the Indian market. The company has partnered with the global innovator of Citicoline, Ferrer Internacional, Spain, to make Somazina available in the country. This is an important product in the management of stroke and has been used for the treatment of post-stroke patients around the world. Somazina is indicated for improving cognitive function in patients who have suffered from stroke or cerebral infarction, or who have undergone a brain surgery or have suffered from head injuries. Each year about 15 Lakh people suffer from stroke in India. Cerebral Stroke is the third leading cause of deaths in India, as per the Global Burden of Disease Study 2013. Citicoline is a widely used neuro-protectant to help accelerate the recovery of these patients. It is used in both ischemic and haemorrhagic strokes, and provides a compelling option to physicians treating stroke patients. "Citicoline is safe to use and may have a beneficial effect in stroke patients. Citicoline is the only drug, that in a number of different clinical stroke trials, has had some neuroprotective effect," said Dr Atul Prasad, director and Senior consultant, BLK Super specialty hospital, Delhi. Commenting on the launch, Mr Alok Sonig, senior vice-president and head of India Business, Dr Reddy's said, "We are excited about the partnership with Ferrer and launch of Somazina which addresses significant unmet need in patients, whose quality of life gets severely compromised after having a stroke. Somazina has proven benefits in post-stroke rehabilitation and is a critical solution in fighting this debilitating disease. With the launch of Somazina® and our recent acquisition of Nootropil, through the UCB brands' acquisition, we look forward to building our presence in the Neurology segment and making a difference to the lives of patients who have had the misfortune to suffer a stroke." ]]> <![CDATA[IIT-B's new breakthrough to cut dialysis cost by 50%]]> https://biospectrumindia.com/interviews/95/4719/iit-bs-new-breakthrough-to-cut-dialysis-cost-by-50.html https://biospectrumindia.com/interviews/95/4719/iit-bs-new-breakthrough-to-cut-dialysis-cost-by-50.html Sun, 17 May 2015 08:45:00 +0530 With the number of Indian diabetics to hit 101 million by 2030, there is a huge demand for dialysis and kidney treatments. According to data published by a hemodialyzer manufacturing company, around 42 percent of the world's kidney sufferers are present in the Asia Pacific region. 60 percent of the patients of chronic kidney diseases (CKD) in India are either diabetic or suffer from high blood pressure. The dialysis market in India is expected to witness a robust growth in the coming years. The demand for dialysis is growing at a rate of 31 percent compared to 6 percent in the US and 8 percent in the rest of the world. The evolving dialysis market in offers remarkable growth opportunities due to factors such as increase in healthcare affordability, government initiatives, and presence of a large patient base. According to an AIIMS study, around 90 percent of the 2, 30,000 people who develop kidney failure in India die due to high cost of treatments. Many local healthcare providers like Apollo and Fortis have increased their dialysis centers to meet the demand, however due to the high cost, these treatments are inaccessible to the poor. Delivery of dialysis services is pathetically poor in this country making new research and cutting edge technologies for kidney treatments a 'crying need.' The dialyzers necessary for treatment are imported and this further enhances the cost of the treatments. A sizeable number of patients suffering from kidney failure are unable to undergo dialysis treatment regularly as the facilities are provided mainly in private hospitals and the cost of the treatment in these hospitals is much more than in government hospitals. For the 1.2 billion population of the country, India has less than 1,000 nephrologists. The process of dialysis alone has over a hundred processes and protocols that need continuous monitoring, thus making renal care supremely complex and expensive and, thereby, rendering the Indian market unrewarding. "The Indian and global markets for dialysis are huge," added Prof. Bellare, "The Indian market alone for hemodialysis is estimated to be around $152 million. Many advantages offered by this hemodialyzer will make it attractive for patients suffering from kidney failure, and also those running and planning to set up dialysis centers. This may help to sharply increase the growth of global dialysis market as it can be made more affordable and thereby can reach a large section of the population at the base of the pyramid who suffer from this unfortunate condition." The hollow-fiber membrane (HFM) developed by the team has completed laboratory tests and awaits pre-clinical trials. This work has led to five peer reviewed international publications, one Indian Patent, and one PCT. Both Indian and an international patents have been procured for the product. Prof. Bellare explained, "We are the first in India to develop an indigenous and low-cost pilot plant for production of these membranes." The DiscoveryThere are two important achievements here. Firstly, IIT-B is the first globally to make a composite hollow fiber membranes (HFMs) with a novel composite material that is a special admixture of polysulfone with Vitamin-E. This imparts a dual functionality enhancement-simultaneous improvements in biocompatibility and in separation performance. Secondly, the group is the first in India to develop an indigenous and low-cost pilot plant for the continuous production of hollow-fiber membranes to be used in hemodialysis and other applications at production rates of several kilometers per day. The team has obtained a national as well as international patent for this novel compound and the manufacturing process of the HFMs. The group working on this includes past PhD student Mr Ganpat Dahe, current PhD students Mr Rohit Teotia and Mr Surendra Verma, past MTech student Ms Shipra Batra and current MTech student Mr Sujit Das, together with several support staff and interns. "There are many aspects to the delivery of dialysis care, and ours is a small but significant advance in the big picture," said Prof. Bellare, "But it is one that I hope can nucleate something impactful. In India, currently, most of the instruments and consumables are imported from abroad including the HFM dialyzer. There is news of multinationals coming and setting up plants here. However, import duty and taxes increase the overall cost of dialysis." An additional cost component is the time required for the patient and dialysis center, in terms of the duration and frequency of treatment, and for the need of super-specialists to handle any side-reactions that do occur from time to time in a section of patients. All this adds to the cost, which can be impacted by the innovation. The heart of this treatment modality is the hemodialyzer, whose core component is the hollow fiber membrane (HFM) filter. "We have developed a pilot plant to fabricate HFM indigenously. The high efficiency of our fabrication process together with the material reduces the overall treatment time for dialysis patients. Additionally, the superior bio-compatibility of this HFM reduces side effects that occur due to poor bio-compatibility," he added. The unique biomaterial makes the membrane more efficient and highly bio-compatible with blood, by which it decreases the overall treatment time and hence reduces the side effects that arise from lack of biocompatibility. The team has demonstrated the safety of the biomaterial through various case studies, elaborated in the paper published in the prestigious journal Biomaterials. "Our study shows reduction in Reactive Oxygen Species (ROS) generation in case of our novel composite material due to incorporation of an additive which is a peroxyl radical scavenger. The membrane is also proved to reduce oxidative stress and confirms antioxidative property in cell lines. The membrane also shows lesser protein adsorption on its surface and hence reduces the platelet adhesion and activation of coagulation pathways. Two fold less hemolysis is observed in our membrane when compared to commercial membrane. No inflammatory responses were observed in our membrane, which implies the superior compatibility of our biomaterial," explained Prof. Bellare. The superior performance and bio-compatibility of the HFM has already been demonstrated through lab experiments and the team is currently ready with the prototype for an extensive animal trial. Following pre-clinical trials in animals the membrane can be tested for human trials. Prof. Bellare noted, "However, restrictions in animal experiments and lack of facilities for the same, together with regulatory barriers for human trials prevent us from moving as fast as we would like. The cost involved is also formidable for an educational and research institution like ours." Some of the questions that Prof. Bellare answered. Excerpts Can this technology be converted into an artificial bio-organ? Our technology could lead to research into newer devices such as implantable/wearable artificial kidneys, including cell based ones, and other bio-artificial organs. Apart from that, our HFM technology can be used to speed up ongoing research and nucleate new research that eventually could make artificial as well as bio-artificial organs such as liver, pancreas, and lungs. Our pilot plant enables us to manufacture tailor made fibers from various novel polymers and blends including new experimental ones that would be more useful in bio-artificial organs. How can this innovation spur research into medical and wearable devices research for kidney dialysis?Hollow fiber membranes can be used in several biomedical applications. High performance helps in miniaturization. Low protein adsorption makes it washable and reusable. We have manufactured the tailor made fiber material and membrane module. This may help in developing wearable devices for kidney dialysis. In regular dialysis a patient has to go for 3 to 4 hours of treatment in the hospital or a dialysis center several times a week. In case of wearable devices one need not lie down on a bed for 3 to 4 hours, 3 times a week. He or she can wear the device and can carry on with their normal work life. Hospital charges will no longer be as big of an issue since it will be a point of care device. However, effective advice and periodic follow-up with skilled nephrologists would still be essential, and visits to dialysis centers for upkeep would likely still be needed. What stage of development is the product currently in?We have proven the superior performance and bio-compatibility of our HFM at the laboratory level. Certain selective tests have been done in animals. Currently we are ready with our prototype for an extensive animal trial. Now it needs preclinical proving in an animal model followed by a clinical trial. How is the funding for the research managed?We have benefited by funds we have competitively won as sponsored projects from Department of Science and Technology, and currently from the Department of Biotechnology (DBT), which is providing us funds for conducting laboratory experiments. Despite our recent efforts with a scheme run by a subsidiary of the DBT, we have not been successful in raising funds for proof of concept in animals, which would have speedily led to clinical trials in humans. If we can cultivate suitable private partnerships and Government sponsors, it may help us in conducting animal and clinical trials quickly, which would be followed by launch of a product in the dialyzer market, an event that could help so many afflicted by the disease. Even more important, it could spur completely new treatment devices like wearable, even implantable, bioartificial devices to manage not only kidney failure, but may other life threatening organs. ]]> <![CDATA[IIT graduate develops new tool for cancer diagnosis]]> https://biospectrumindia.com/news/95/6344/iit-graduate-develops-new-tool-for-cancer-diagnosis.html https://biospectrumindia.com/news/95/6344/iit-graduate-develops-new-tool-for-cancer-diagnosis.html Sat, 16 May 2015 08:31:00 +0530 IIT-Delhi graduate, Mr Rohit Bhargava, currently a professor at the University of Illinois, Urbana-Champaign, has developed a stainless staining technique that provides a new tool for scientists and clinicians for better diagnosis of cancer. Till date, prepared biopsy samples are stained under a light microscope to examine them clearly. Mr Bhargava has developed label-free chemical imaging by using infrared spectroscopic imaging for microscopy, to provide the same data as molecular stains. Instead of using stains, the new methodology measures chemical constitution of cells and tissues directly. The outcome of this, is that, the molecular stains can be replicated using the intrinsic molecular contrast of the tissues and computations, without staining the tissues. Instead of providing stained biopsy images, the study depends on computation. "Infrared and optical imaging seemed to be in different modes for getting important information in pathology. This study shows that a close link between these two, allows users to choose the best method for addressing their needs," said Mr Bhargava. Thus, any sample can be stained to anticipate the stains without material cost or time, or even the effort of precious tissue left pristine for downstream studies. Another usage of this approach can be in the small amount of sample analysis, for example, a thin needle biopsy method. According to Mr Bhargava, the development of this approach promises to have an immediate and long-term impact in pathological methods, to a multiplied molecular science in both research and clinical practices. ]]> <![CDATA[India finally gets its magical vaccine]]> https://biospectrumindia.com/features/95/7008/india-finally-gets-its-magical-vaccine.html https://biospectrumindia.com/features/95/7008/india-finally-gets-its-magical-vaccine.html Fri, 15 May 2015 17:41:32 +0530 India has realized its dream of developing an indigenous vaccine against the rotavirus, the main cause behind diarrhoea that results in 10 lakh hospitalizations and kills nearly 80 thousand children under the age of 5 years. Developed by Hyderabad-based Bharat Biotech, the oral rotavirus vaccine, ROTAVAC has been proved to be safe and effective in preventing rotavirus diarrhoea. The vaccine was launched on March 09, 2015 by the Prime Minister, Mr Narendra Modi whose enthusiasm was visible given his focus on the 'Make in India' initiative. The PM lauded the vaccine as an example of India`s capabilities for high-end research and development; manufacture of sophisticated pharmaceutical products in India; and an effective public private partnership model for finding affordable solutions to societal challenges. "The development of the rotavirus vaccine will inspire higher levels of research, development and manufacturing activities in India, not just in medical science, but also in other advanced areas of science and technology," remarked Mr Modi. This announcement fulfilled Bharat Biotech's promise of a $1/ dose vaccine to governments in low income countries. The company has received commercial licensure and the vaccine is safe to use. The company that was involved in the development and production of the vaccine was selected in 1997-1998 by the India-US Vaccine Action Program and the standard government procedures. This is the third such vaccine available globally against Rotavirus and, at the current prices, the cheapest."ROTAVAC represents the successful research and development of a novel vaccine from the developing world with global standards," said Dr Krishna M Ella, chairman and managing director of Bharat Biotech. "ROTAVAC is a testament of our strong vision and commitment to develop affordable health care solutions for infectious diseases." As per Dr Ella, "A novel vaccine innovated in India, developed in India and made in India, is a big boost to the 'Make in India' initiative by the government. The launch fortifies our mission to identify public health problems and make affordable life-saving vaccines available to children wherever they are born." It was a belief that was shown some twenty eight years ago and might have been looked at with a lot of scepticism back then. But it was Dr MK Bhan, former secretary of the Department of Biotechnology (DBT) whose dream of manufacturing an indigenous rotavirus vaccine one day kept the efforts multiplying and the project expanding. Dr Bhan termed the launch as a culmination of decades of selfless efforts by researchers across the globe. He added, "Ideas are good only when they are pursued to the very end. The Rotavac story is a good mix of innovation and purpose."Dr Harry Greenberg, associate dean, Stanford University added, "The ROTAVAC project is a beautiful example of the great power of team science. The vaccine is a culmination of a very large and disparate group of people and organizations all working together for a common goal: to produce a safe, effective and affordable vaccine to prevent severe rotavirus associated diarrhoea in Indian children."The randomized, double-blind, placebo-controlled phase III clinical trial enrolled 6,799 infants in India (aged six to seven weeks at the time of enrolment) at three sites-the Center for Health Research and Development, Society for Applied Studies (SAS) in New Delhi; Shirdi Sai Baba Rural Hospital, KEM Hospital Research Center in Vadu, Pune; and Christian Medical College (CMC) in Vellore. Infants enrolled in the study received ROTAVAC and the Universal Immunization Program (UIP) vaccines, including Oral Polio Vaccine (OPV). When the immune responses to OPV were tested, the result showed that infants receiving OPV at the same time as vaccine generated comparable immune responses to all three polio serotypes as the infants receiving OPV without ROTAVAC; this result supports the concurrent administration of OPV and ROTAVAC. Innovative PPP The interesting fact about the vaccine is that it was developed through a unique social innovation partnership that brought together the experience and expertise of Indian and international researchers as well as the public and private sectors. The vaccine development partnership was supported by DBT, the Bill and Melinda Gates Foundation, the Research Council of Norway, and the UK Department for International Development. Bharat Biotech invested important technical, manufacturing, and financial resources towards vaccine development. The support laboratory was the Translational Health Science and Technology Institute. Quintiles was responsible for several aspects of the trial including medical monitoring, data management, site monitoring, pharmacovigilance, and biostatistics. Good Clinical Practice compliance of the clinical trials was audited by ANTHA Clinical Quality Assurance. The rotavirus vaccine development despite having taken decades to materialize, showcases India's biotech potential. At the same time, while half of the battle has been already won, we cannot afford to be satisfied only by having the vaccine. Now starts the second stage of its implementation in the Universal Immunization Program (UIP) and awareness among masses which of course is a herculean task in itself. Yet the best part is that we already have existing networks from polio campaign which can be pressed in to action with renewed vigour. Journey of Rotavac: âˆ? 1985-86: Dr MK Bhan discovers strain, 116E during his routine testing at the All India Institute of Medical Sciences (AIIMS), New Delhi. He partners with Dr Roger Glass, a diarrhoeal expert working then at the CDC's rotavirus laboratory. Around the same time, Dr Durga Dass discovers another strain, l321 at the Indian Institute of Science (IISc), Bangalore. He collaborates with Dr Harry Greenberg of Stanford University for further research. âˆ? 1987: Both the naturally occuring, weakened strains studied by the two independent research teams working parallely under the Indo-US Vaccine Action Program, bilateral program implemented since 1987 by DBT and NIH. âˆ? 2000: Consortium of partners including Bharat Biotech, CDC, NIH, AIIMS, Stanford University, and IISc, submitted a proposal to PATH and DBT for support to move the two vaccine candidates through production, testing and surveillance. âˆ? 2003: Partners meet to discuss the clinical studies strategies of the 116E and 1321 vaccine lots. After clearance of protocols for the phase I, first Indian trials began at AIIMS. âˆ? 2004-2005: The trial results showed the 116E strain being more effective, providing immunity to 36.6 percent of recipients as compared to 15.4 percent of l321 recipients. On the basis of results, focus was completely put on the 116E strain for further development. âˆ? 2006: The consortium initiated combined phase Ib/IIa dose escalation study of the 116E vaccine candidate in infants at the National Institute of Immunology, Delhi.âˆ? 2008: The conclution of Phase Ib/IIa trial showed no identified safety concerns and demonstrated robust immune response in 89 percent of infants. âˆ? 2011: The Phase III trials of 116E (now named Rotavac) on 6,799 infants began across three sites in India. âˆ? 2013: The data from trial results presented at the international symposium on 'Rotavirus Vaccines for India-The Evidence and the Promise', showed Rotavac to have an excellent safety and efficacy profile. âˆ? 2015: Vaccine launched and set to be implemented in national immunization programe. ]]> <![CDATA[Wockhardt recalls its drug in the US]]> https://biospectrumindia.com/news/95/6377/wockhardt-recalls-its-drug-in-the-us.html https://biospectrumindia.com/news/95/6377/wockhardt-recalls-its-drug-in-the-us.html Fri, 15 May 2015 16:08:47 +0530 Wockhardt USA, the American arm of the Mumbai-based firm Wockhardt, has decided to recall 93,393 bottles of Captopril tablets, for failing to meet specifications for thickness, according to information available on the United States food and Drug Administration (USFDA)'s site. Captopril tablets is used for the treatment of high blood pressure and kidney problems caused by diabetes. It has been classified as a Class-II recall which FDA defined as "a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote". ]]> <![CDATA[The unsung heroes of the Medicine Makers Power List 2015]]> https://biospectrumindia.com/news/95/7100/the-unsung-heroes-of-the-medicine-makers-power-list-2015.html https://biospectrumindia.com/news/95/7100/the-unsung-heroes-of-the-medicine-makers-power-list-2015.html Fri, 15 May 2015 13:41:00 +0530 The Medicine Maker, a UK-based publication's power list has featured numerous luminaries on its prestigious rolls. The objective of the list was to find the most influential medicine makers for 2015. The power list, which has been compiled from reader nominations and with the help of experts, is based solely on merit of work. It also features fellow Indians who are doing remarkably well in their respective fields. Biospectrum takes a look at some of the unsung heroes of the power list 2015. 1. Vikramaditya G Yadav, assistant professor, Department of Chemical and Biological Engineering, The University of British Columbia, Canada'Biosynthonics' - a novel paradigm for discovering and synthesizing potent bioactive molecules - is a focus of Dr Yadav's research group. The group also focuses on formulation and assembly of drugs and their translation to certain pathological conditions. They recently embarked on the development of a brain-on-chip device for preclinical testing of anti-neurodegeneration drugs. 2. Indresh K Srivastava, vice president, Product Realization, Protein SciencesWith a strong background in vaccine development, particularly immunogen design, purification, analytical and formulation development, Mr Srivastava has published extensively in these areas. He served on the NIH special emphasis study section focused on vaccine development for 10 years and spent more than 12 years at Chiron Corporation/Novartis Vaccines and Diagnostics. 3. Manish Soman, president and CEO, SciformixIn just three years, Mr Soman helped Sciformix to evolve from a niche area into a leading global scientific process organization for the biopharmaceutical, generic pharmaceutical, consumer product, medical device and contract research industries. 4. Tarit Mukhopadhyay, lecturer, Vaccine Bioprocess Development, University College London, UKMr Mukhopadhyay is a biochemical engineer who has been active in vaccine development for over 10 years. He creates scale-down models to accurately mimic the production environment. "With this, I can employ high-throughput techniques to quickly attain the optimum manufacturing process," he explains. "This methodology has been successfully applied to bacterial and virus vaccines." 5. Ajaz Hussain, executive director, The National Institute for Pharmaceutical Technology and Education, USAMr Hussain has previously worked for the FDA, where he became deputy director of its Office of Pharmaceutical Studies in 2000. He also held a Senior Biomedical Research Scientist position. He is widely recognized for his leadership of several FDA initiatives such as Process Analytical Technology and Pharmaceutical Quality for the 21st Century 6. Dalvir Gill, chief executive officer and member of the Board of Directors, TransCelerate BioPharmaWith over 25 years in drug development, Mr Gill says that his most satisfying career achievement is leading the charge as CEO for TransCelerate BioPharma. "It's an innovative collaboration across the global biopharmaceutical R&D community to identify and solve common R&D challenges, in order to deliver high-quality medicines to patients," he says. 7. Raman Singh, president, Mundipharma Asia Pacific, Latin America, Middle East and AfricaMr Singh oversees all aspects of the Mundipharma business - a leader in pain management - across his territories, which operate as a network of independent companies. Prior to this appointment, Mr Singh was the VP of Commercial Operations for Emerging Markets at GlaxoSmithKline. A nominator commented that Mr Singh is "putting patients at the center of healthcare business." ]]> <![CDATA[Biodiversity Act and the cut-flower export]]> https://biospectrumindia.com/news/95/6258/biodiversity-act-and-the-cut-flower-export.html https://biospectrumindia.com/news/95/6258/biodiversity-act-and-the-cut-flower-export.html Fri, 15 May 2015 09:19:00 +0530 India's export of cut flowers have declined from Rs 340 crore in 2007-08 to Rs 294 crore in 2009-10, stated a paper published in the journal of Asian Business Management by Ms Kirandeep Kaur and Mr Imran Saleem of GNIMS, Mumbai University. Experts in the field believe that the volumes and quality along with the lack of infrastructure are the major deterrents in flagging off the export of cut flowers. Since flowers are perishable commodities, care is needed at the production level. Giving attention to production/productivity factors, quality of produce and availability of quality planting material, will encourage the business. Post-harvesmanagement systems and infrastructure also needed to be developed."The shelf life of flowers needs considerable improvement. On-shelf management practices must be standardized and research should focus on lowering input costs and on improving low cost indigenous systems. Tissue culture and bio-technology hold a lot of promise and should be exploited to ensure better high yielding floral varieties with in-built resistance to plant diseases," according to a paper published in CAB (college of agricultural banking) calling by Mr EV Murray and Mr KRP Rao.In order to achieve this an extensive amount of research is needed. But, unfortunately, the NBA act does not make it conducive for research, as highlighted by the experts in the story. Series of long approvals which are time consuming and uncertainity stops anyone who wishes to do explore the field for research purpose. The country's diverse agro-climatic conditions and geographical locations is suited for growing various types of flowers. India has a rich biodiversity and its proper utilization can be very beneficial both scientifically and economically to the country. But, in a zeal to protect it from exploitation, the Act is proving to be suicidal. Biodiversity resources are renewable resources and as suggested by Dr Ramaswamy, dean, inStem, the best way to conserve these is to make it commercially an important thing. The more it is used, the better it is conserved. ]]> <![CDATA[â€œTax benefits for companies working in biodiversity conservationâ€?]]> https://biospectrumindia.com/interviews/95/8314/tax-benefits-for-companies-working-in-biodiversity-conservation.html https://biospectrumindia.com/interviews/95/8314/tax-benefits-for-companies-working-in-biodiversity-conservation.html Fri, 15 May 2015 08:53:00 +0530 Q: Do we require current Biodiversity Act which many feel is hampering the innovation in biotech? It is a noteworthy fact that India has 26 recognized endemic centers that are home to nearly a third of all the flowering plants identified and described to date. The Biodiversity Act defines biological diversity as the variability among living organisms from all sources and the ecological complexes of which they are part, and includes diversity within species or between species and of ecosystems. Therefore, it is very important to safeguard India's biodiversity and with this view the biological diversity act, 2002 plays an important role. According to section 3, all foreign nationals require prior approval from NBA for obtaining biological resources. It is important to safeguard the biological resources from being misused by any entity. The current timeline to dispose the application is six months from the date of its receipts. That is hampering the innovation in biotech by delaying the approval process from the date of receipt of application. In my view, the timeline should not be more than two months to grant the approval as the long time period would refrain foreign nationals from investing their resources in India. Subsequently, a balance of convenience has to be maintained in safeguarding the biological resources and at the same time respecting the research and development activities of scientific institutions. Any person desirous of transferring results of research relating to biological resources obtained from India for monetary consideration to foreign nationals, companies and Non Resident Indians (NRIs), should definitely seek approval for transferring results of research in the national interest of the country. Q: What is the extent to which the law should be amended?There should be a provision of express request by increasing the fee schedule for applying for approval for access to biological resources to expedite the grant approval process. This will not only encourage more entities to apply for the approval but at the same time will generate more revenues for the Indian government. Secondly, the current timeline to grant approval for transferring results of research is within a period of three months from the receipt of the application. In this case also, the provision of express request should be introduced by increasing the fee schedule. Q: What do you suggest on how these (law) can be improvised for the mutual benefit of biodiversity conservation and for biotech industry?Special lucrative schemes should be introduced for the mutual benefit of biodiversity conservation and for the biotech industry. For example, tax benefits for the biotech entities researching in the area of biodiversity conservation and for the betterment of mankind. Indirectly, it will lead to innovation and innovation will lead to job creation in the country. ]]> <![CDATA[â€œCurrent Biodiversity Act is draconianâ€?]]> https://biospectrumindia.com/interviews/95/7298/current-biodiversity-act-is-draconian.html https://biospectrumindia.com/interviews/95/7298/current-biodiversity-act-is-draconian.html Fri, 15 May 2015 08:08:00 +0530 Q: What is your take on the Biodiversity Act which is being viewed as a hurdle for bioinnovation?The law should be made enabling for the active use of biodiversity - rather than discourage the use of biodiversity. The best way to conserve biodiversity is to make it commercially an important thing. The more it is used, the better it is conserved. The current act is a sure way to slowly kill India's largest resource its biodiversity, slowly.Q: How is it hampering the overall research?The current Biodiversity act is draconian. From an academic sense too, this law is regressive. On the one side the Government of India is trying to attract the best talent in the world to come back to India to do science. The Biodiversity act dramatically restricts foreign nationals, including OCI card holders from doing research on Indian biodiversity. This is very poorly thought through and it does not look like that there is any active scientist or academic doing research in modern life sciences and using biodiversity in the panel.Q: How can we rectify it? The bill has been hijacked by a very narrow group of ideologists. What we need is an inclusive bill that is made with representation from all. The bill has to be forward thinking and enabling. ]]> <![CDATA[Unitus Seed Fund Launch StartHealth Competition for start-ups]]> https://biospectrumindia.com/news/95/6283/unitus-seed-fund-launch-starthealth-competition-for-start-ups.html https://biospectrumindia.com/news/95/6283/unitus-seed-fund-launch-starthealth-competition-for-start-ups.html Thu, 14 May 2015 12:56:58 +0530 Unitus Seed Fund, a venture seed fund supporting start-ups has announced the StartHealth Competition, a nationwide challenge to identify promising early-stage health-tech start-ups. The winner will receive a cash prize of Rs 10 lakhs. Additionally, the winner and the runner-up will get an opportunity to pitch for a direct entry to its StartHealth program which includes receiving up to Rs 50 lakhs of non-dilutive fund, support from StartHealth partners PATH, Pfizer, Manipal Hospitals and Narayana Health, and a potential seed investment of Rs one crore. The start-ups will be assessed based on the factors including impact on the masses, leadership and team, innovation, business model, and presentation quality. Areas of particular interest include, Healthcare service models enabled by technology and Healthcare diagnostic solutions leveraging on technology innovations. Sectors include medical devices, diagnostics and therapeutics with wide primary healthcare impact, mobile monitoring, online marketplaces, app-based services and enterprise management and healthcare service delivery, and all the spaces where technological innovation and increased mobile-internet penetration are key drivers. "Technology innovation is a key factor to making better healthcare services accessible and affordable for the masses in India. Our healthcare partners provide an amazing resource to early-stage health-tech entrepreneurs as they prepare for bringing their innovations to market in the country," said Mr Dave Richards, managing partner, Unitus Seed Fund. Applications open on May 11, 2015 and the deadline for submission of application is June 17, 2015. ]]> <![CDATA[Dr Reddy's Q4 revenues grows 8 percent Y-o-Y]]> https://biospectrumindia.com/news/95/4949/dr-reddys-q4-revenues-grows-8-percent-y-o-y.html https://biospectrumindia.com/news/95/4949/dr-reddys-q4-revenues-grows-8-percent-y-o-y.html Thu, 14 May 2015 12:15:00 +0530 HYDERABAD: Dr Reddy's Laboratories reported 8 percent annual growth in its consolidated net profit for Q4. Dr Reddy's Laboratories reported a net profit of Rs 519 crore over sales of Rs 3,870 crore in the quarter ended March 31, 2015. The company had reported a net profit of Rs 482 crore on sales of Rs 3,480 crore in the corresponding quarter of last fiscal. For the year 2014-15 the company has seen 12 percent growth in revenues at Rs 14,819 crore with 3 percent growth in net profit at Rs 2,218 crore. Dr Reddy's net profit in the Q4 was impacted by forex losses of Rs 84.3 crore high research & development (R&D) expenses which came in at Rs 514 crore against Rs 398 crore year-on-year. Operating profit (EBITDA) of the company came in at Rs 810 crore against Rs 781 crore year-on-year and its operating margin, a major of profitability declined 80 basis points annually to 21 percent. The company's co-chairman and chief executive officer Mr GV Prasad said, "Overall, our results demonstrate our commitment to execute on our strategy, across businesses, as we constantly strengthen our focus on patients and providing them access." The company has declared a dividend of Rs 20 per share. ]]> <![CDATA[AstraZeneca, Abbott to co-develop diagnostic tests]]> https://biospectrumindia.com/news/95/6188/astrazeneca-abbott-to-co-develop-diagnostic-tests.html https://biospectrumindia.com/news/95/6188/astrazeneca-abbott-to-co-develop-diagnostic-tests.html Thu, 14 May 2015 12:09:41 +0530 AstraZeneca (AZ) has announced that it has entered into an agreement with Abbott to develop companion diagnostic tests, to identify patients with severe asthma who are most likely to benefit from the investigational biological therapy, tralokinumab. To date, no companion diagnostic blood tests have been approved for use in asthma. Under the terms of the agreement, Abbott will develop and commercialize the diagnostic tests to measure serum levels of the proteins periostin and DPP4 (dipeptidyl peptidase-4), which have been identified as potential predictive biomarkers of up-regulated IL-13 in severe asthma. The tests will be developed in conjunction with AZ's Phase III trial of tralokinumab, a potential treatment for patients with severe, inadequately controlled asthma, developed by the company's biologics research and development arm, MedImmune. Periostin has been previously described as a potential biomarker for asthma1, and DPP4 is a novel and promising predictive biomarker identified by MedImmune. The tralokinumab Phase III program will evaluate the safety and effectiveness of tralokinumab in reducing the rate of asthma exacerbations in adults and adolescents with severe, inadequately controlled asthma despite receiving inhaled corticosteroids plus long-acting Î²2-agonist. The program will also assess the effect of tralokinumab on lung function, patient-reported asthma symptoms and quality of life, as well as investigate whether serum periostin or DPP4 could identify patients who are most likely to benefit from tralokinumab. Mr Bing Yao, senior vice-president and head of MedImmune's Respiratory, Inflammation and Autoimmunity Innovative Medicines Unit said, "This partnership with Abbott to develop companion diagnostics for tralokinumab is an important step in delivering on our ambition to bring innovative options for patients who continue to suffer with severe asthma. We anticipate that physicians will ultimately use these tests to better identify patients likely to benefit most from tralokinumab to bring their condition under control. We are on the cusp of a new era in personalized healthcare, one which will see great improvements for patients treated with respiratory medicines." Personalized healthcare is at the center of AZ's approach to drug discovery and development and this collaboration is a part of the company's strategy to seek external partners to develop companion diagnostics that will help transform patients' lives. ]]> <![CDATA[Danaher to acquire Pall Corp for $13.8 bn]]> https://biospectrumindia.com/news/95/6488/danaher-to-acquire-pall-corp-for-13-8-bn.html https://biospectrumindia.com/news/95/6488/danaher-to-acquire-pall-corp-for-13-8-bn.html Thu, 14 May 2015 12:01:42 +0530 Danaher Corp announced that it has entered into a definitive merger agreement with Pall Corporation pursuant to which Danaher will acquire all of the outstanding shares of Pall for $127.20 per share in cash, or a total enterprise value of approximately $13.8 billion, including assumed debt and net of acquired cash. The acquisition has been unanimously approved by the board of directors of each company, and the Pall board of directors has unanimously recommended that Pall shareholders approve the transaction. The transaction is expected to be completed around the end of calendar year 2015. Pall is a leading global provider of filtration, separation and purification solutions that remove contaminants or separate substances from a variety of solids, liquids and gases. Decades of work by Pall's filtration engineers and scientists have built a highly-respected brand on which customers rely to solve their most difficult purification problems across the broad spectrum of life sciences and industry. In its fiscal year ended July 2014, Pall generated consolidated revenues of US $2.8 billion, with US $1.5 billion from its Life Sciences segment and US $1.3 billion from its Industrial segment. The Life Sciences segment serves customers in the fast-growing biopharmaceutical market, as well as food & beverage and medical end markets. Danaher's president and CEO, Mr Thomas P Joyce, Jr., said, "Pall is a highly attractive business, with approximately 75 percent recurring revenues, mid-single digit organic growth and a solid margin profile. Its best-in-class technology, combined with the broadest, most technically-advanced solutions, make it the premier brand in the filtration industry." He further added, "Pall will provide us a leading business with significant runway for expansion and strengthens our life sciences position in the strategically-attractive, high-growth biopharmaceutical market. With the Danaher Business System as a foundation, Pall associates will have the tools to accelerate new product development and improve operational efficiency in the years to come. We look forward to welcoming the Pall team to Danaher." The merger is subject to customary conditions, including approval by Pall's shareholders, receipt of applicable regulatory approvals and the absence of a material adverse effect on Pall. Danaher estimates the Pall acquisition will be approximately US $0.40 accretive to non-GAAP, adjusted diluted net earnings per share in 2016, excluding non-cash amortization, purchase accounting and transaction expenses. ]]> <![CDATA[Lupin acquires MedquÃmica in Brazil]]> https://biospectrumindia.com/news/95/7914/lupin-acquires-medqumica-in-brazil.html https://biospectrumindia.com/news/95/7914/lupin-acquires-medqumica-in-brazil.html Thu, 14 May 2015 11:50:11 +0530 Lupin has announced the acquisition of 100 percent equity stake in MedquÃmica IndÃºstria FarmacÃªutica Brazil, (MedquÃmica) subject to certain closing conditions. The acquisition marks Lupin's foray into the high growth Brazilian market and would also shore up its position in the Latin American pharmaceuticals market given the Company's acquisition of Laboratorios Grin in Mexico last fiscal. Brazil's pharmaceutical market is said to be nearly doubled in size from 2009-2013, expanding at a CAGR of 17 percent, driven by growing public health expenditure and increasing household income. Incorporated in 1975, MedquÃmica is engaged in the development, manufacturing and commercialization of branded generics, pure generics and OTC products. Medquimica recorded net revenues of approximately $31 million (BRL 94 million) in calendar year 2014 and has over 550 employees. Commenting on the acquisition, Ms Vinita Gupta, chief executive officer, Lupin said, "We are very pleased with our entry into the Brazilian market through MedquÃmica. There are a lot of synergies to the acquisition and Lupin would not only leverage its research and technology strengths to build a high quality product pipeline but also use MedquÃmica's commercial presence to expand business by targeting niche high-growth therapy segments. The acquisition is also a reflection of Lupin's commitment to expand into the Latin American market and an important part of Lupin's Emerging Markets play going forward." Mr Cristiano Boccia, managing director of Graycliff Partners, Brazil (one of the private equity shareholders of MedquÃmica) said, "I am delighted with MedquÃmica joining hands with Lupin. We believe that MedquÃmica's future and growth would be better served with the global business management and technology expertise that Lupin brings to the table. It offers enhanced capabilities to roll out high quality pharmaceutical products which would benefit customers in the Brazilian market." ]]> <![CDATA[Untapped seaweed potential & Biodiversity Act]]> https://biospectrumindia.com/views/95/6911/untapped-seaweed-potential-biodiversity-act.html https://biospectrumindia.com/views/95/6911/untapped-seaweed-potential-biodiversity-act.html Thu, 14 May 2015 08:40:00 +0530 In 17th century Japan, scientists discovered the beneficial effects of agar-agar, a resin extracted from marine macroalgae called seaweeds (plant-like organismsthat are attached to rocks etc) which grow abundantly on the coastline. Since then agar-agar, a jelly like substance is used in a wide variety of products such as medicines, milk additives, ice cream, chocolates, pet foods.With over 7,000 km of coastline, India is an ideal location to grow seaweeds, which are broadly categorized as red, brown, and green algae, in abundant quantities tomeet domestic demands and export to the needy world. The reality in India is different. India actually imports huge quantities of agar-agar to meet the growing needs, thanks mainly to the restrictions placed on its cultivation and exports by the Biodiversity Act, 2002.Seaweeds is not a plant native to India. It is found abundantly in coastal areas around the world yet India's overzealous regulators wanted to protect this and put various restrictions on it. Under the Biodiversity Act, any grower has to get a permission from the Biodiversity Authority and pay a 5 percent royalty on the exportearnings. The export fee is supposed to be used to take up conservation activities.A detailed study on the socio-economic potential of seaweeds in the country was done in 2010 by Dr M Krishnan at the Central Institute of Brackish Water Aquaculture, Chennai and Dr R Narayankumar at the Central Marine Untapped Seaweed Potential & Fisheries Research Institute, Kochi. According to their study, India has 434 species of red seaweeds, 194 species of brown seaweeds, and 216 species of green seaweeds. Both red and brown seaweeds grow only in seawater proximity. Green algae grows on land based waterbodies too.The study has estimated that India can grow more than one million tonnes of seaweeds in six states-Gujarat, Tamil Nadu, Kerala, Andhra Pradesh, Maharashtra and Andaman & Nicobar Islands. In the global markets each tonne of average quality agar-agar is sold for more than $2000 (Rs 120,000) and the country has the potential to generate more than Rs 200 crore in foreign exchange annually from this besides providing additional income and gainful employment to thousands of people on the coastline.However, India imports agar-agar worth more than Rs 50 crore annually. In India, serious commercial production of seaweeds was started in 2007 by Pepsico Holdings as part of its corporate social responsibility (CSR) initiatives. Pepsico helped form hundreds self help groups (SHGs) comprising mostly women in the coastal areas of Ramanathapuram district in Tamil Nadu and helped grow seaweeds and extract the byproducts. It has become so popular that seaweeds are actually called "Pepsi Pasi" (Pepsi algae) in southern parts of Tamil Nadu.According to the study by Dr Krishnan and Dr NarayanaandKumar, under the Pepsi project, SHGs in the fishing villages of Vedalai, Thonithurai, Ariyankkundu, and R Vadakadu operate more than 1,000 rafts growing seaweeds. Most SHGs obtain a yield of 50 kg per raft per day. Seaweed farming offered 161 and 144 days of employment annually in Rameshwaram and Mandpam areas which is much more than the 100 days of employment offered by the central employment scheme, MGNREGA at great public cost. An Indian company, Sea6Energy, founded by young engineers from IIT Madras, and mentored by biotechnologist, Dr Shrikumar Suryanarayan, has extracted good quality biofuels from seaweeds. All their efforts to get permission to grow seaweeds along the country's shoreline has been stopped by various environmental regulations. This company is now growing seaweeds in association with partners in Indonesia and even faraway Brazil just to get materials to do more research work on biofuels. On the other hand, the Philippines and Indonesia grow seaweeds abundantly, encouraged by government policies and dominate the global supplies. How is the Biodiversity Act hampering the growth of this activity? Various experts BioSpectrum spoke to indicate that the tedious, time-consuming process of getting permission from the Biodiversity Authority to handle seaweeds is a dampener for entrepreneurs eyeing this field. Also, entrepreneurs cannot access capital from venture funds or event top banks which have foreign share holdings. This is because the Biodiversity Act prohibits any entity with foreign holdings from doing any commercial activity with seaweeds and other plant based materials. Since foreign holding is not defined under the Act, if a foreigner or foreign entity owns even a single share in such an enterprise, it will be barred from the activity by the Act. Also, Access and Benefit Sharing (ABS) is mandated by the Act and entrepreneurs have to share part of the surpluses generated with the local community where seaweeds are grown. Entrepreneurs want to do this. However, ABS has to handled by the Biodiversity Committees to be set up in each state under the Act. Even a state like Tamil Nadu has not set up such a committee. So all the collections under the Act lie unused in the coffers of the central government. So this is yet another mindless government initiative which was started with the good intention protecting the nation's natural resources from "rapacious foreigners" actually used to stymie indigenous entrepreneurship. ]]> <![CDATA[Godavari Biorefineries raises Rs 90 crore in equity]]> https://biospectrumindia.com/news/95/5713/godavari-biorefineries-raises-rs-90-crore-in-equity.html https://biospectrumindia.com/news/95/5713/godavari-biorefineries-raises-rs-90-crore-in-equity.html Wed, 13 May 2015 12:57:26 +0530 Godavari Biorefineries, one of India's sustainable manufacturers of foods, biofuels, specialty chemicals, power and related products using sugarcane as the primary feedstock, announced that it has raised Rs 90 crore ($15 million) in equity, from funds managed by Mandala Capital. In pursuit of its vision to increase the current level of extracted value, Godavari has been investing heavily in innovation, research and collaboration in the production of sugar, power and ethanol and in the manufacture of value added, complex chemicals derived from ethanol as well as the waste products of the sugar refining process. The funds invested by Mandala Capital will be used for phase I of this strategy, which involves a new manufacturing plant for specialty chemicals, an increased capacity for ethanol production, debottlenecking of existing plants and strengthening the company's utility infrastructure. It will also fund an expanded facility for R&D. Godavari expects a turnover exceeding Rs 1,200 crores for the year ended March 2016. Mr Samir Somaiya, chairman, Godavari Biorefineries, said, "....For us, innovation in green chemistry is a source of growth and expansion for the company as well as our commitment to the triple bottom line of social, ecological and financial gain." Godavari Biorefineries, a member of the Somaiya Group, was established in 1939 and is one of the leading companies in the Indian sugar industry. It has sugar, ethanol, power and chemical plants in Karnataka and Maharashtra. Mandala Capital manages private equity funds that invest in companies focused on the agribusiness sector in the Indian subcontinent. Mr Uday Garg, CEO, Mandala Capital, said, "We have followed Godavari for several years and witnessed firsthand the transformation of the company from a traditional sugar business into an integrated bio refinery....." ]]> <![CDATA[ Eli Lilly inks pact with BioNTech]]> https://biospectrumindia.com/news/95/6570/-eli-lilly-inks-pact-with-biontech.html https://biospectrumindia.com/news/95/6570/-eli-lilly-inks-pact-with-biontech.html Wed, 13 May 2015 12:26:32 +0530 Eli Lilly and BioNTech has announced they have entered into a research collaboration to discover novel cancer immunotherapies. The companies will seek to use the power of the body's own immune system to attack cancer cells and create possible new treatment options for cancer patients. Leveraging the scientific expertise between the two organizations will collaborate to identify and validate novel tumor targets and their corresponding T cell receptors (TCRs) in one or more types of cancer. These tumor targets and TCRs may then be engineered and developed into potent and selective cancer therapies. Under the terms of the agreement, BioNTech will receive a $30 million signing fee. For each potential medicine, it could receive over $300 million in development, regulatory and commercial milestones. If successfully commercialized, BioNTech would also be eligible for tiered royalty payments up to double-digits. In addition, subject to the terms of the agreement, Lilly will also make a $30 million equity investment in BioNTech's subsidiary, Cell and Gene Therapies, which specializes in the research and development of TCR and chimeric antigen receptor immunotherapeutics. Further financial terms were not disclosed. "In the past few years, we've seen some amazing breakthroughs in immuno-oncology; however, we believe these are just the tip of the iceberg. Lilly's partnership with BioNTech represents the next wave of cancer immunotherapy and is focused on the identification of functional T cell receptors that can be used to redirect a patient's natural immune system to fight cancer," said Dr Greg Plowman, vice-president of Lilly Oncology Research. Dr Ugur Sahin, CEO of BioNTech, said, "We are very pleased to collaborate with a leading oncology company such as Lilly. Lilly's expertise and track record make it an ideal collaborator for both companies to leverage the full power of BioNTech's functional T cell receptor technologies to develop novel cancer therapies that harness the immune system." He further added, "This alliance is in line with our strategy to collaborate with companies that have a similar fascination, drive and commitment in developing and commercializing truly innovative and disruptive immunotherapies for the treatment of cancer." ]]> <![CDATA[Biodiversity laws: Over regulation a cause? ]]> https://biospectrumindia.com/features/95/6854/biodiversity-laws-over-regulation-a-cause-.html https://biospectrumindia.com/features/95/6854/biodiversity-laws-over-regulation-a-cause-.html Wed, 13 May 2015 08:05:00 +0530 Over regulation defeating the purpose?The NBA makes it cumbersome and uncertain for companies and individuals to access and work with India's Biodiversity, and conservation of the resources have turned into abandoning these from their proper utilization. "The current Biodiversity act is draconian. From an academic sense too, this law is regressive. On the one side the Government of India is trying to attract the best talent in the world to come back to India to do science. The Biodiversity act dramatically restricts foreign nationals, including OCI card holders from doing research on Indian biodiversity. This is very poorly thought through and it does not look like that there is any active scientist or academic doing research in modern life sciences and using biodiversity in the panel," said Dr S Ramaswamy who feels that bill has been hijacked by a very narrow group of ideologists. "What we need is an inclusive bill that is made with representation. Speaking on the similar lines, Dr Sivakumar further added, "In the zeal to protect the Biodiversity and ensure that local communities in whose domain the Biodiversity resource exists , do not get a raw deal, we are curtailing the generation of new knowledge ( e.g new and unidentified species and strains) and potential commercial benefits from these resources like new drugs, enzymes and genes which could help drive even more efforts to conserve and document these resources by overly regulating the access to these resources. This defeats the purposes of the Act." "Because regulation is stringent, the outcome could still be uncertain after years of hard work. India's experience in bioprospecting is still at its infancy: lack of human resource of the right capacity is a major problem; our academia and industry are yet to feel comfort in working together; there is not enough inter-disciplinary cross talk and hardly any trans-disciplinary institutional structure; and there is insufficient programme management skill in our funding agencies. We need to learn a great deal from international experience on how to be innovative in research," said Dr Natesh. Time to do away with itThe overwhelming feeling is that there is a need to amend the law in terms of shortening timeline to grant the approval. Ms Prity Khastgir is of the opinion that there should be a provision of express request by increasing the fee schedule for applying for approval for access to biological resources to expedite the grant approval process. "This will not only encourage more entities to apply for the approval but at the same time will generate more revenues for the Indian government," she said while also suggesting introduction of special lucrative schemes for the mutual benefit of biodiversity conservation and for the biotech industry. As an example, Ms Khastgir mentioned, "Tax benefits for the biotech entities researching in the area of biodiversity conservation and for the betterment of mankind. Indirectly, it will lead to innovation and innovation will lead to job creation in the country."According to Dr Reena Singh, "It is the sovereign right of India to control the use of country's resources. But, law should be reviewed. If Indian companies and residents are not able to come up with commercial products of Indian resources in stipulated time frame then foreigners or non-resident Indians might be invited or given the chance with benefit sharing mechanism or any other mechanism so that the optimal utilization of Indian resources can be achieved." "It has to be recognized that being in possession of biodiversity and associated knowledge is one thing but converting these into socially or commercially viable products or processes is quite another," informed Dr S Natesh who points out that latter involves not only research and innovation but injection of considerable financial investment. Separate governing bodyCurrently the sufficient distinction between using biological diversity for research and that for commercialization is lacking. In most cases, we just do not have enough scientific knowledge about our wild-occurring biodiversity.Experts suggest that government of India must appoint a high power committee that consists of practicing scientists in microbiology, industrial biotechnology, modern agriculture, veterinary medicine, traditional medicine, economists, NGO's, representatives from industry, etc. The body should do revisions for the bill with the aim or both securing our biodiversity, yet creating economic value from it.A separate governing body, as per Ms Prity Khastagir, will address the issues related to biodiversity utilization for research purposes and provide one stop solution to the companies researching in this area. Echoing a broader sentiment, she said, "It will benefit in expediting the approval process."Dr Reena Singh endorses the viewpoint when she mentioned, "The governing body (with members of multi-disciplinary field) may be given the responsibility to develop and monitor the entire programme on biodiversity utilization and bio-prospecting. This body may have the centralized information on all the research activities of biodiversity utilization and could be an important link between research and commercialization. industrial stakeholders may considered to be included as the member of the governing body." However, Dr S Natesh believes that restrictions or any governing body may not help the purpose. Making his point, he quotes an example. "Take medicinal plant species as a case in point: For most of them we do not have adequate basic data on reproductive phenology, pollination and dispersal mechanisms, breeding cycles, cytology, seasonal and regional variations of bioactive compounds, pathways of secondary metabolites and their genetic control mechanisms, and other features that are fundamental to our understanding of the species. This is true most other feral species. Obviously, translation of this knowledge into application will take considerable inputs of time and talent not to mention money," explained Dr Natesh further, "Commercialization is even more distant. Even the skillsets required for early and late stage research are very different! There should be no restriction whatsoever on carrying out basic, knowledge-generation research. I am not sure if there should be a separate governing mechanism for this purpose. Just exempting it from the "permit" and "approval'' system is all that is required."Evoking nationalism to preserve the biodiversity in this case as explained by experts, has to be broadly in interest of the nation and not just serve merely as a lock on an unexplored treasure for the sake of it. The consensus on realistic approach ensuring both conservation of biodiversity as well as safeguarding the interests of industry and farmers has to be arrived at through extensive deliberations. There is a no escape route for that!Possible Remediesâ€¢ Make NRI's and OCI's equivalent to Indian citizens for the purpose of the NBA.â€¢ Make the definition of "Indian company" consistent with the generally accepted definition. i.e a company is Indian if it is more than 50 percent Indian owned. â€¢ Make the approval process automatic for certain categories of biodiversity access ( e.g isolation and screening of microorganisms) where there is no danger to the conservation of biological diversity since the act of isolation and screening only enhances the knowledge of the biodiversity present and preserves it. â€¢ Exempt new knowledge generation (research and IP filing) from the approval process. New knowledge adds to the pool of traditional knowledge and is a beneficial activity and should be encouraged and not regulated. â€¢ As far as approvals for commercialization are concerned - If the Indian economy is benefitted in the commercialization of a process based on biodiversity access, then it should be considered as fair and equitable benefit sharing under the NBA (e.g. tax revenues, export earnings, employment generation all benefit the Indian economy).Basic research in areas like Taxonomy, which only generates knowledge and not profits, in a different perspective and be excluded from the ambit of the Biodiversity act. I suggest the following amendment to the section 5 of the Biodiversity Act to make this effect, said Dr Rajan.â€¢ 5. (1) The provisions of sections 3 and 4 shall not apply to basic research on biodiversity and collaborative research projects involving transfer or exchange of biological resources or information relating thereto between institutions, including Government sponsored institutions of India, and such institutions in other countries, if such collaborative research projects satisfy the conditions specified in sub-section (3). ]]> <![CDATA[Dr Kiran Mazumdar ranked #2 in global Medicine Maker Power List 2015]]> https://biospectrumindia.com/news/95/7152/dr-kiran-mazumdar-ranked-2-in-global-medicine-maker-power-list-2015.html https://biospectrumindia.com/news/95/7152/dr-kiran-mazumdar-ranked-2-in-global-medicine-maker-power-list-2015.html Tue, 12 May 2015 13:26:44 +0530 This iconic leader is the only India-based business leader featuring on the list. She appears on the list alongside global leaders from the industry, including CEOs, professors, Nobel Prize-winning researchers and many other celebrated scientists from the pharmaceutical world. The top 5 on the list are:1. Anthony Fauci , director, National Institute of Allergy and Infectious Diseases, USA2. Kiran Mazumdar-Shaw, CMD, Biocon3. Sir Andrew Witty, CEO, GlaxoSmithKline4. Arthur D Levinson, CEO, Calico5. Heather Bresch, CEO, Mylan The prestigious list also includes names like Pascal Soriot, CEO, AstraZeneca; Robert A. Bradway, chairman & CEO, Amgen; Ian C Read, chairman, Pfizer; Prof Tyler Jacks, Koch Institute for Integrative Cancer Research; Prof Charles Cooney, Massachusetts Institute of Technology, USA; Prof Harold Varmus, Weil Cornell Medical College and many more. The Medicine Maker is a UK-based publication that is distributed worldwide to a targeted European and North American industry professionals. The power list has been compiled from reader nominations with the help of expert judges and is based entirely on merit. ]]> <![CDATA[FDA nod for Roche's cobas KRAS mutation test]]> https://biospectrumindia.com/news/95/5941/fda-nod-for-roches-cobas-kras-mutation-test.html https://biospectrumindia.com/news/95/5941/fda-nod-for-roches-cobas-kras-mutation-test.html Tue, 12 May 2015 11:24:48 +0530 Roche has announced that the US Food and Drug Administration (US FDA) has approved the cobas KRAS mutation Test for diagnostic use. The real-time PCR test is designed to identify KRAS mutations in tumor samples from metastatic colorectal cancer (mCRC) patients and aid clinicians in determining a therapeutic path for them. "As more targeted treatment options for cancer patients become available, the importance of identifying the right molecular information to define their disease becomes critical," said Mr Paul Brown, head, Roche Molecular Diagnostics. He added, "The cobas KRAS Mutation Test gives clinicians actionable insights that enable them to make informed decisions about treatment for their patient. With this approval, Roche now offers the most comprehensive companion diagnostic FDA approved portfolio for oncology in the US, including tests for BRAF (melanoma), EGFR (lung cancer) and KRAS (mCRC) mutations." According to the Centers for Disease Control and Prevention, colorectal cancer is the second leading cause of cancer-related deaths in the United States and the third most common cancer in men and women. The cobas KRAS Mutation Test is intended to be used as an aid in the identification of mCRC patients for whom treatment with Erbitux (cetuximab) or Vectibix (panitumumab) may be effective if no KRAS mutation is present. ]]> <![CDATA[Biodiversity laws: Simply obsolete or genuine concerns? ]]> https://biospectrumindia.com/features/95/5992/biodiversity-laws-simply-obsolete-or-genuine-concerns-.html https://biospectrumindia.com/features/95/5992/biodiversity-laws-simply-obsolete-or-genuine-concerns-.html Tue, 12 May 2015 08:56:00 +0530 A group of students at the prestigious Indian Institute of Technology (IIT), Chennai, got together a few years ago and decided to turn entrepreneurs. They had managed to extract good quality biofuel from seaweeds that grow abundantly along the long stretches of Chennai's sea shores. With great enthusiasm they formed a company, found a mentor and initial financial support to make their dreams a reality. After a few years, their dream run has hit a major hurdle. It is a law, enacted with great fanfare by the National Democratic Alliance (NDA) government led by Prime Minister Atal Behari Vajpayee in 2002, called the Biodiversity Act, 2002. The Vajpayee government enacted this omnibus legislation in good faith to protect India's rich biodiversity. It was also an international obligation for India as a signatory to the Convention on biological Diversity (CBD). CBD itself was the result of the high profile Earth Summit in June 1992 held at Rio de Janeiro, Brazil, as the world's first global meet to save the environment. Now what is the problem with the Biodiversity Act? The framers of the Biodiversity Act have put many stringent provisions in their overzealous attempt to protect everything that lives and grows in India. Let us take the first major hurdle. The seaweed entrepreneurs cannot access venture capital from most of India's leading financial institutions except the government-owned banks. Because, almost all the Bluechip financial institutions have substantial foreign share and investment holding. The Biodiversity Act prohibits foreigners and foreign companies from having any say in the running of companies that deal with biological resources for commercial exploitation. What is intriguing is that even after 12 years of its existence, the government has not defined 'foreign holding' for the purpose of the Biodiversity Act. So even if a foreign entity holds a single share or anyone of the senior managers of a company dealing with biological resources, it is equivalent to 'foreign holding' and a big no under the Act. The Biodiversity Board will not give the required permission. Second major hurdle is that despite one of the largest coastlines in the world, it is difficult to get sufficient stretches of sea surface to grow seaweeds or any other such marine algae in the country. There are too many other regulations that govern the use of coastal land. So the only option is to look for foreign shores to do this. Entrepreneurs who are looking at using various tools of biotechnology to turn India's rich biodiversity are confronted with many other problems induced by the Biodiversity Act. Permission is required from the state-level Biodiversity Boards or the central board to do any business related to the use of biological resources. A five percent fee on investments has to be paid to the Board. Only research work can be done. No patent application can be made on any product developed without the permission of the Board. Speed is essential in filing of patents. But the central Biodiversity Board meets infrequently. It has met only 32 times in the 12 years since its launch in January 2003. That is on an average 2.6 meetings a year. Then there are huge gaps in between meetings. The last meeting of the Board was held in December 2014. The proceedings and decisions taken at the 25th meeting held in September 2012 only has been made public so far. So has the Biodiversity Act gone overboard in implementing its mandate? Only a handful of products have come out of using the nation's rich biodiversity. Thousands of potential breakthroughs in the use of medicine using our rich diversity remain untapped thanks to the hurdles caused by this Act. The National Biodiversity Act (NBA) 2002 was legislated to protect the sovereign rights of the country over its biological resources. The imposition of several stringent restrictions on the access to biodiversity was for guarding the country against likely deluge of biopirates from within and outside India. However, more than a decade after the Rio Summit, bioprospecting has had minimal impact the world over. India cannot even cite one successful outcome of prospecting (and consequent sharing of benefits) commensurate with its rich biodiversity. While the extent of responsibility of the biodiversity laws for this state of affairs can be debated, it stands to reason that no law should be as stringent and narrow as to hamper domestic research and international collaboration. Agreeing with this assessment, Dr Priyadarsanan Dharma Rajan, senior fellow and program leader (Ecosytems and Global Change), Ashoka Trust for Research in Ecology and the Environment (ATree), said, "India enacted the law mainly to regulate access to biodiversity and facilitate benefit-sharing. Despite imposing severe restrictions on the access to biodiversity in the country, India's gains in sharing commercial benefits of biodiversity among its stakeholders are minimal." Dr Priyan and his team had earlier proposed amendments in the obsolete clauses of certain sections of law in a letter to the then union minister for environment and forests, Mr A Raja. Most developing countries, it seems in hindsight, have grossly overestimated the value of their bio wealth, felt Dr S Natesh, Consultant Advisor, National Institute of Immunology. He explained, "Soon after the Convention on Biological Diversity was concluded at Rio de Janeiro, it was expected that the technology-savvy northern nations would make a beeline for the microbes, plants and animals of the countries in the southern hemisphere. Bioprospecting agreements were prophesied to provide a steady pipeline of revenue from the global north to the global south.""The movement should be free for research purposes without much restriction," said Mr Ram Kaundinya, director general, ABLE-AG who added, "As caretakers of the land and environment, farmers know that rich, healthy soil delivers life sustaining benefits to the crops and livestock they raise. However, traditional intensive cultivation and land management practices can be hard on soil, reducing its quantity, quality and capacity to sustain life. With this in mind, the plant science industry has developed technologies and solutions -from novel crop protection products to seeds enhanced through biotechnology - that enable farmers to incorporate soil-friendly, sustainable practices such as conservation tillage." Detrimental to innovation?Each expert has his own way of describing the problem though most agree that when innovation is a buzz word, the law in present form, no longer holds value. As per Ms Priti Khastgir, Indian Patent Attorney, Tech Corp Legal LLP, "The current Biodiversity act is hampering innovation in biotech by delaying the approval process from the date of receipt of application. In my view, the timeline should not be more than 2 months to grant the approval as the long time period would refrain foreign nationals from investing their resources in India. Subsequently, a balance of convenience has to be maintained in safeguarding the biological resources and at the same time respecting the research and development activities of scientific institutions." "The law is very discouraging," says Dr Reena Singh, Fellow and Area Convener, Centre for Mycorrhizal Research, The Energy and Resources Institute (TERI) adding further, "Presently, non-Indians cannot have access to Indian genetic resources and even if they have the expertise for biotech innovation, they will have to undergo bilateral agreements and material transfer agreements and long approval processes. Through these bilateral agreements, basic research can still be done but commercialization is being affected by this act as Indian companies cannot hire NRI's/OCI's as scientific advisors or senior managers otherwise Indian Company seize to be Indian Company and have to undergo long approval processes. Agreed Dr Shrikumar Suryanarayan, chairman, Sea6 Energy who said that while the step seems very laudable from the point of view of preventing Indian resources from being "exploited" by foreigners and non-Indians without benefit to the local people - but what is the fallout The Act does not describe, who is Indian and who is not? Explaining further, he added, "Indian companies that are innovating in the area of biodiversity are constrained from raising any "foreign risk capital" at all to stay clear of having any foreign shareholding and therefore having to take "prior approvals" under the provisions of the NBA 2002. Surprisingly this definition of what is an Indian company is different from normally accepted practice ( i.e >50 percent Indian shareholding is considered an Indian company)."Dr Priyadarsanan highlighted another issue, "It is perplexing to note that the Rules and guidelines framed to implement the Biological Diversity Act, are being irrationally imposed on fundamental research and curtails the scientific freedom of individual Scientists." For example, section 5 of the Act 5. (1) The provisions of sections 3 and 4 shall not apply to collaborative research. Projects involving transfer or exchange of biological resources or information relating thereto between institutions, including Government sponsored institutions of India, and such institutions in other countries, if such collaborative research projects satisfy the conditions specified in sub-section (3). "The law should be made enabling for the active use of biodiversity - rather than discourage the use of biodiversity. The best way to conserve biodiversity is to make it commercially an important thing. The more it is used, the better it is conserved. The current act is a sure way to slowly kill India's largest resource its biodiversity, slowly," said Dr S Ramaswamy, professor and dean, Institute for Stem Cell Biology and Regenerative Medicine, and CEO, Center for Cellular and Molecular Platforms, National Center for Biological Sciences (NCBS). To be continued.... ]]> <![CDATA[WHO includes hep C, TB and cancer drugs in essential medicines list]]> https://biospectrumindia.com/news/95/5534/who-includes-hep-c-tb-and-cancer-drugs-in-essential-medicines-list.html https://biospectrumindia.com/news/95/5534/who-includes-hep-c-tb-and-cancer-drugs-in-essential-medicines-list.html Mon, 11 May 2015 13:35:51 +0530 The move opens the way to improve access to innovative medicines that show clear clinical benefits and could have enormous public health impact globally. "When new effective medicines emerge to safely treat serious and widespread diseases, it is vital to ensure that everyone who needs them can obtain them," said WHO director-general, Dr Margaret Chan. "Placing them on the list is a first step in that direction." Increasingly, governments and institutions around the world are using the WHO list to guide the development of their own essential medicines lists, because they know that every medicine listed has been vetted for efficacy, safety and quality, and that there has been a comparative cost-effectiveness evaluation with other alternatives in the same class of medicines. The list is updated every two years by an expert committee, made up of recognized specialists from academia, research and the medical and pharmaceutical professions. This year, the committee underscored the urgent need to take action to promote equitable access and use of several new highly effective medicines, some of which are currently too costly even for high-income countries. These included new medicines to treat hepatitis C, which affects about 150 million people globally, killing approximately half a million people each year, when chronic infection develops into liver cirrhosis or liver cancer. The disease is present in high- and lower-income countries alike, with higher concentrations in several middle- and low-income countries. Until recently, treatment for the disease presented minimal therapeutic benefits and serious side effects. Five new medicines - direct acting oral antivirals - have recently come on the market transforming chronic hepatitis C from a barely manageable to a curable condition, the new medicines have few side effects and high tolerance in patients. All 5 products, including sofosbuvir and daclatasvir, were included in the list. But high prices currently make them unaffordable and thus inaccessible to most people who need them. Cancers figure among the leading causes of illness and death worldwide, with approximately 14 million new cases and 8.2 million cancer-related deaths in 2012. The number of new cases is expected to rise by about 70% over the next 2 decades. New breakthroughs have been made in cancer treatment in the last years, which prompted WHO to revise the full cancer segment of the Essential Medicines List this year: 52 products were reviewed and 30 treatments confirmed, with 16 new medicines included in the List. TB remains one of the world's most deadly infectious diseases. In 2013, 9 million people fell ill with TB and 1.5 million died from the disease. Over 95 percent of TB deaths occur in low- and middle-income countries. After about 45 years of scarce innovation for TB medicines, 5 new products were included in the EML. Four of these, including bedaquiline and delamanid, target multi-drug-resistant TB. The committee also recommended supporting off-label uses in cases where there is clear evidence of major health benefits, though no licensed indication, such as for many medicines for children. ]]> <![CDATA[GSK, UNC-Chapel Hill partner for HIV cure]]> https://biospectrumindia.com/news/95/8029/gsk-unc-chapel-hill-partner-for-hiv-cure.html https://biospectrumindia.com/news/95/8029/gsk-unc-chapel-hill-partner-for-hiv-cure.html Mon, 11 May 2015 11:57:36 +0530 The University of North Carolina at Chapel Hill and GSK has announced the creation of a dedicated HIV Cure center and a jointly owned new company that will focus on discovering a cure for HIV/AIDS. This unique public-private partnership will redefine the traditional way of conducting research and create a new model to seek the breakthroughs needed to tackle an extraordinarily challenging global health issue. The HIV Cure center will be located on the UNC-Chapel Hill campus and will focus exclusively on finding a cure for HIV/AIDS. The new company, Qura Therapeutics, will handle the business side of the partnership, including intellectual property, commercialization, manufacturing and governance. Together, the HIV Cure center and Qura Therapeutics will serve as a catalyst for additional partners and public funding that will likely be needed to eradicate HIV worldwide. The collaboration is also expected to recruit and attract top talent from around the world. "The excitement of this public-private partnership lies in its vast potential. Carolina has been at the forefront of HIV/AIDS research for the last 30 years. This first of its kind, joint-ownership model is a novel approach toward finding a cure, and we hope it serves as an invitation to the world's best researchers and scientists. Today, Carolina's best are taking another major step in the global fight against HIV/AIDS," said UNC-Chapel Hill Chancellor Mr Carol L Folt. "Like UNC, GSK has a long legacy of HIV research success. From the development of the world's first breakthrough medicine for HIV patients in the 1980s, to our leadership in the market today through ViiV Healthcare, we're continuously challenging ourselves to meet the needs of patients," GSK CEO Sir Andrew Witty said. He added, "This partnership is a testament to our past and present leadership, innovation and commitment to this field. We are inspired by the confidence that with the right resources and research teams, we will be able to make a meaningful impact towards a cure for HIV." UNC-Chapel Hill and GSK will focus on the latest scientific approaches to curing HIV, including a leading research approach toward an HIV cure, sometimes called "shock and kill." This approach seeks to reveal the hidden virus that persists in people with HIV infection despite successful drug therapy, and augment the patient's immune system to clear these last traces of the virus and infected cells. Part of this new paradigm was first tested at UNC-Chapel Hill and in 2012 a team led by UNC-Chapel Hill researchers demonstrated that latent HIV might be unmasked by new therapies. Recently, researchers at the university received Food and Drug Administration approval for a study in HIV-positive volunteers to combine this technique and an immune-boosting strategy. Through the new company, GSK will invest $4 million per year for five years to fund the initial HIV Cure center research plan, and a small research team from GSK will move to Chapel Hill to be co-located with UNC researchers. The University will provide world-class laboratory space on its medical campus for the HIV Cure center and the new company. GSK will be contributing its expertise and know-how in medicines discovery, development and manufacturing, and UNC-Chapel Hill will bring to the table its research and translational medicine capabilities, talent, as well as access to patients and funding. GSK's investment in the HIV Cure center is separate from its investment in the discovery of novel antiretroviral (ARV) therapies in support of ViiV Healthcare, a global specialist HIV company dedicated to delivering advances in treatment and care for people living with HIV and owned by GSK, Pfizer and Shionogi. GSK's HIV Discovery Performance Unit will continue its work on new ARVs in the Research Triangle Park area of North Carolina. ViiV has significant clinical expertise and will play an advisory role to the HIV Cure center and Qura Therapeutics. ]]> <![CDATA[AbbVie, Roche's Venetoclax gets FDA breakthrough status]]> https://biospectrumindia.com/news/95/6573/abbvie-roches-venetoclax-gets-fda-breakthrough-status.html https://biospectrumindia.com/news/95/6573/abbvie-roches-venetoclax-gets-fda-breakthrough-status.html Mon, 11 May 2015 11:51:26 +0530 AbbVie has announced that its investigational medicine Venetoclax, an inhibitor of the B-cell lymphoma-2 (BCL-2) protein that is being developed in partnership with Genentech and Roche, has been granted Breakthrough Therapy Designation by the FDA for the treatment of chronic lymphocytic leukemia (CLL) in previously treated (relapsed/refractory) patients with the 17p deletion genetic mutation. CLL accounts for approximately one quarter of the new cases of leukemia diagnosed in the United States. Approximately 3-10 percent of CLL patients have 17p deletion at diagnosis, and it occurs in 30-50 percent of patients with relapsed/refractory CLL. The 17p deletion mutation is a genomic alteration in which a part of chromosome 17 is absent. The median life expectancy for CLL patients with 17p deletion is less than 2-3 years. "The breakthrough therapy designation of venetoclax supports the continued development of this investigational medicine in CLL patients with 17p deletion. The continuing advancement of the venetoclax development program is one example of AbbVie's focus on delivering innovative medicines that address unmet clinical needs," said Dr Michael Severino, executive vice-president of research and development and chief scientific officer, AbbVie. According to the FDA, breakthrough therapy designation is intended to expedite the development and review of drugs for serious or life-threatening conditions. The criteria for Breakthrough Therapy Designation includes preliminary clinical evidence demonstrating a drug may have substantial improvement on at least one clinically significant endpoint compared to available therapy. A breakthrough therapy designation conveys all of the fast track program features, as well as more intensive FDA guidance on an efficient drug development program. ]]> <![CDATA[General Atlantic exits Jubilant Life Sciences]]> https://biospectrumindia.com/news/95/5454/general-atlantic-exits-jubilant-life-sciences.html https://biospectrumindia.com/news/95/5454/general-atlantic-exits-jubilant-life-sciences.html Mon, 11 May 2015 11:02:52 +0530 General Atlantic has sold its six percent stake in Jubilant Life Sciences for about Rs 145 crore via open market transactions over the past month, according to reports. Reportedly, on May 5, General Atlantic sold its 5.49 percent stake at Rs 150 per share aggregating to around Rs 131 crore. Earlier, on April 7, General Atlantic had offloaded another 0.5 percent stake for nearly Rs 14 crore at approximately Rs 173 per share. The Private Equity (PE) major, General Atlantic had invested around Rs 240 crore in Jubilant Life Sciences to fund the pharma company's growth and acquisition plans in 2005. ]]> <![CDATA[USAIC BioPharma & Healthcare Summit 2015]]> https://biospectrumindia.com/news/95/4736/usaic-biopharma-healthcare-summit-2015.html https://biospectrumindia.com/news/95/4736/usaic-biopharma-healthcare-summit-2015.html Sun, 10 May 2015 08:16:00 +0530 USAIC's BioPharma & Healthcare Summit 2015 will bring together key stakeholders from the industry, academia, investors, foundations and government to engage in active debate and idea generation on routes for successful collaboration between global BioPharma companies and academia, and India's BioPharma industry and academia. The Summit will focus on the Big Data, therapeutic areas of oncology, cardiovascular and metabolic diseases; neurodegenerative diseases; along with discussions on BioPharma R&D strategy & trends; Industry-Academic Partnerships; Funding Innovation and M&A trends. PricewaterhouseCoopers LLP (PwC) is the Knowledge Partner. USAIC commissioned PwC USA Position Paper will be released at the Summit. The annual summit is a must attend gathering for global BioPharma industry leaders, academicians and investors. Over eight prominent global R&D heads are participating besides the therapeutic R&D heads of CVMD, oncology and neurosciences. There will be fireside chat between Dr Tachi Yamada-Takeda and Mr Christopher Viehbacher, former CEO of Sanofi. For the first time, Global Chief Medical Officer Panel is being introduced. It is led by Dr Michael Rosenblatt, EVP and chief medical officer of Merck and Co. "Global BioPharma innovation is all about collaborative research. Startups, big BioPharma and academics need to work together for a common goal of bringing novel therapeutics which save human lives or improve the quality of lives worldwide," said Mr Karun Rishi, President of the USA India Chamber of Commerce. It is time India with one-sixth of the world population plays a leading role in the global BioPharma innovation ecosystem. This very well fits into Prime Minister Narendra Modi's "Make in India" initiative. Besides an economic value creation, BioPharma and ealthcare innovation has an added advantage of India playing a key role in alleviating global human sufferings by way of new drugs and therapies," said Mr Rishi. "Fundamental, broad-scale innovation is critical if we want to remain successful as an industry," said Mr Andy Plump, chief medical and scientific officer, Takeda and USAIC Advisory Board Member. "The breadth of innovative science and discovery occurring in India is truly impressive and Takeda is enthusiastic about forging meaningful, long-term partnerships there. USAIC is an important venue to help spark those conversations that we hope will lead to important advances for patients." "The only way we can make the 'right to healthcare' truly universal is through collaborative innovation where companies come together to share knowledge, risks and opportunities. Synergistic partnerships between Indian and US entities have helped take affordable novel drugs and low-cost bio-medical equipment to patients globally. USAIC's annual BioPharma & Healthcare Summit in Boston provides a vital platform to connect key stakeholders who want to make a difference to global healthcare. I look forward to participating in the summit and hope to see you there," said Dr Kiran Mazumdar Shaw, CMD, Biocon and USAIC Advisory Board member. Collaborative research is critical to drive medical innovation, especially as it is becoming increasingly important for both companies and hospitals to prioritize their research programs," said Mr Martin Mackay, executive vice president and global head of R&D at Alexion and USAIC Advisory Board member. "At Alexion, we focus exclusively on developing therapies that have the potential to transform the lives of patients suffering from severe and rare diseases, and we are open to collaboration opportunities that help us work towards our goal of providing hope to patients who are often underserved due to the rarity of their disorder." ]]> <![CDATA[Biodiversity: A common heritage]]> https://biospectrumindia.com/features/95/5156/biodiversity-a-common-heritage.html https://biospectrumindia.com/features/95/5156/biodiversity-a-common-heritage.html Sun, 10 May 2015 08:13:00 +0530 NBA does not allow free access and sharing of genetic resources. The alienation of biodiversity from the common heritage of humanity would adversely affect global food security, biodiversity research, investment and international relations. Another argument is that the livelihoods of farmers and indigenous communities in the developing countries are innately linked to biodiversity, making them more vulnerable to restrictions on access to the global plant genetic resource. Every country in the world uses exotic genetic material to enhance the productivity of its crops and livestock as the genetic limits of the native stock can be overcome only by incorporating genes from such material. State ownership over biodiversity, however, ignores the world's interdependence on genetic resources and the evolutionary history of crop plants. Cultivated plants have originated in different parts of the world, so nations are in a complex network of plant genetic interdependence. No region can afford to isolate itself, or be isolated, from access to plant germplasm of other regions. This bondage is growing ever stronger, due to increasing loss of agricultural biodiversity and climate change. The International Treaty on Plant Genetic Resources for Food and Agriculture, albeit legally non-binding, reflects appreciation of the world's interdependence on genetic resources.Dr Rajan gives a logical assessment when he said, "There is no denying the fact that India so far has contributed precious little in terms of inventions in biotechnology and genetic engineering that has made any impact in the field. Yet the country is self-sufficient in important commercial technologies in this area. Many a company in India is engaged in research and development of vaccines and diagnostic tools. Public sector in India is capable of producing transgenic crops and cloned animals. We have just uncouthly adapted the ideas and technologies from the developed countries, mostly available in the public domain. Those who cry hoarse over appropriation of age-old traditional knowledge, forget about the gains they are making out of public knowledge produced by others, though legally." "All revolutions-green, white and blue-that salvaged India from hunger and made it self-sufficient in food would have been impossible without exotic genetic resources. Even today Indian farmers introduce and domesticate foreign plants and animals for commercial utilization. In fact 60 percent of modern rice varieties released in India have exotic progenitors; in the case of industrial crops it is 92 percent. Such transfusion is essential to maintain productivity and mitigate eventualities like pest and disease epidemics. But with the introduction of Biological Diversity Act, 2002, which restricts availability of genetic resources from India to the rest of the world, we have sent an unsolicited invitation for equal and opposite reactions. We stand to lose the moral authority to use exotic biological materials without the formal permission and benefit sharing with the respective countries of origin," added Dr Rajan.The historic treatment of biological resources as a common heritage has benefited humans. Countries have gained more than their individual contribution from germplasm exchanges through the Consultative Group on International Agricultural Research. The international seed treaty on major food crops, which came into force in 2004, was a major step in this direction. Dr Ram Kaundinya representing the agriculture focus group of ABLE on behalf of industry confirmed its commitment towards comprehensive stewardship of biotechnology and sustainable agriculture, as it gets leveraged for a long term benefit of society. "However member companies in their individual capacities are expected to believe in an approach that carefully considers the wishes of the society, environment protection, increased productivity , general improvement in the quality of life as biotech products are developed seeks to conserve and protect natural resource bio-diversity and consider concerns of local communities on the selection, design, production and introduction of products and publicly advocate positions consistent with their commitment," he added. ]]> <![CDATA[THSTI scientists develop novel tools that could turn off bad genes in bacteria ]]> https://biospectrumindia.com/news/95/4308/thsti-scientists-develop-novel-tools-that-could-turn-off-bad-genes-in-bacteria-.html https://biospectrumindia.com/news/95/4308/thsti-scientists-develop-novel-tools-that-could-turn-off-bad-genes-in-bacteria-.html Sat, 09 May 2015 08:54:00 +0530 With their research funded by the Department of Biotechnology (DBT), two scientists at the THSTI which is a part of the Faridabad biocluster, have independently created tools that have successfully addressed the challenge of studying genes of various diseases causing bacteria including the tuberculosis causing mycobacterium. Dr Bhabatosh Das, assistant professor at the Center for Human Microbial Ecology, THSTI, and his team have successfully built a delivery tool technically called "vector" for introducing and controlling any gene that they wish to study in a range of bacteria. The scientific intelligence involved in the building of this vector termed as pBD32 (BD is abbreviation for Bhabatosh Das) is the selection of DNA from various sources and bringing them together into one delivery system. pBD32 has a piece of DNA termed as XBS selected from a virus, which in nature was known to attack the cholera bacteria and with the help of this DNA fragment goes and sits inside the bacterial chromosome. Dr Das believed that XBS would come handy to place any gene of interest in other bacterial chromosome to turn the gene "on" or "off". Scientifically this is termed as a stable, broad host range tightly regulated expression system that as described by Dr Das and his team in their Journal of Bacteriology Publication (Volume: 196, Number: 23, December 2014, Pages - 4071 4080) could be used in several bacteria like Vibrio cholerae (causing Cholera) and Klebsiella pneumoniae (causing Pneumonia), Salmonella enterica (causing Typhoid fever), Escherichia coli (lives in human gut). Scientists working across the world like USA, Germany, UK and Japan are using this genetic tool for functional studies in the drug discovery field and highly appreciated the development with encouraging compliments. When it comes to the tuberculosis causing bacterium Mycobacterium tuberculosis, nothing is ever enough as this bacterium has successfully made it difficult for the scientists' to study its essential genes. None of the tools developed till date has been proved to be greatly efficient in elucidating essential gene function in TB. Turning "off" the essential genes is a primary approach but is a major challenge as most of the delivery tools do not achieve finding the exact place where the essential gene sits in the mycobacterial genome and do not have efficient blocking mechanism for causing loss of function. Dr Nisheeth Agarwal, assistant professor at the Vaccine and Infectious Disease Research Center, THSTI, and his team have tackled it by improvising the CRISPRi (Clustered Regularly Interspaced Short Palindromic Repeat Interference) tool for disrupting the mycobacterial genes in a cost effective manner. This tool employs a foreign protein dCas9 borrowed from other bacteria and tweaked by his team to work in mycobacteria, and a stretch of oligonucleotide fragment termed as guide RNA (sgRNA) designed to pair with the gene in the mycobacteria that the scientist would like to disrupt. Dr Agarwal's team has successfully engineered specific guide RNAs-dCas9 complex for many essential genes of the mycobacteria and have disrupted them from becoming functional. This tool is simple, cost effective and more importantly quicker considering that the tuberculosis causing mycobacteria takes a long time to culture under laboratory conditions and precious time is lost in the absence of quick manipulative tools. More than 50 genes could be inactivated in a short span of six months using this tool in Dr. Agarwal's laboratory. This will enable identifying new pathways unique to M.tuberculosis growth and design drugs against it in a significantly greater pace. The study was published in Nature Communications on 25th February, 2015 and has received worldwide acclaim from the community of eminent TB researchers. ]]> <![CDATA[Alzheimer's disease treatment market to exceed $13 bn by 2023]]> https://biospectrumindia.com/features/95/4711/alzheimers-disease-treatment-market-to-exceed-13-bn-by-2023.html https://biospectrumindia.com/features/95/4711/alzheimers-disease-treatment-market-to-exceed-13-bn-by-2023.html Fri, 08 May 2015 15:20:22 +0530 The global market for Alzheimer's Disease (AD) treatment will more than double in value from $4.9 billion in 2013 to reach an estimated $13.3 billion by 2023, representing a Compound Annual Growth Rate (CAGR) of 10.50 percent, according to research and consulting firm GlobalData. The growth will be driven by the launch of 15 new therapies, including several drug candidates that have the potential to modify the underlying cause of AD. The increasing prevalence of AD and mild cognitive impairment across the 9MM, coupled with advances in diagnostic capability and increased social awareness of the disease, will contribute further to market growth. Dr Kyle S Nicholson, GlobalData's analyst covering neurology, says disease-modifying treatments and novel symptomatic therapies with innovative mechanisms of action will enter the arena during the forecast period and become routinely used in care. He explains: "Following the anticipated approval and launch of first-in-class BACE1 inhibitors and passive immunotherapies in 2018 and 2019, respectively, the AD treatment market will undergo rapid expansion, as several blockbuster drugs are expected to come from these two potentially disease-modifying therapeutic classes. "The experimental monoclonal antibodies (mAbs), Biogen's aducanumab, Eli Lilly's solanezumab and Roche's gantenerumab and crenezumab, will compete with the BACE1 inhibitors, Merck's MK-8931 and AstraZeneca/Eli Lilly's AZD-3293, as both treatment approaches are designed to prevent the formation of senile amyloid plaques." The analyst adds that the symptomatic therapies in the pipeline, such as Lundbeck's LuAE-58054 and Forum's EVP-6124, will also gain market share as the prevalence of symptomatic AD increases throughout the 9MM by 2023. GlobalData anticipates that Namenda, Aricept and Exelon, the current AD drug market leaders with cumulative sales of $4.3 billion in 2013, will maintain strong shares throughout the forecast period. However, their combined sales will fall annually from 2015, with Namenda and Aricept having recently lost patent exclusivity. ]]> <![CDATA[APAC market for psoriasis treatment doubling to $1.2 bn by 2021]]> https://biospectrumindia.com/features/95/7394/apac-market-for-psoriasis-treatment-doubling-to-1-2-bn-by-2021.html https://biospectrumindia.com/features/95/7394/apac-market-for-psoriasis-treatment-doubling-to-1-2-bn-by-2021.html Fri, 08 May 2015 14:32:25 +0530 The Asia-Pacific (APAC) treatment market for psoriasis will almost double in value, from $690 million in 2014 to $1.2 billion by 2021, representing a Compound Annual Growth Rate (CAGR) of 8.4 percent, according to business intelligence provider GBI Research. This expansion, which will occur across the major APAC markets of China, India, Japan and Australia, will be driven by a rising treatment population and the emergence of new competitive drug products, particularly biologics, which are expected to be approved during the forecast period. Mr Rishikesh Mandilwar, analyst for GBI Research, says the uptake of biologics will rise as more products enter the market and healthcare professionals become increasingly confident with their use in the treatment of psoriasis. He explains: "Biologics are very expensive in comparison with conventional systemic drugs, the majority of which have been in use for decades and have lost patent protection. The continued uptake of biologics will increase the annual cost of therapy in APAC countries, propelling market growth. "Recently approved Cosentyx from Novartis and Alzumab from Biocon, both monoclonal antibodies (mAbs) targeting IL-17, a pro-inflammatory cytokine, and CD6 protein specifically, are expected to achieve good market penetration by 2021." The analyst adds that promising late-stage pipeline mAbs, such as brodalumab and ixekizumab, which directly target IL-17, are anticipated to be launched during the forecast period. These treatments will be competitors for already-launched secukinumab, as they all target the same molecule. Mr Mandilwar continues: "Humira, Enbrel, and Remicade, which are potential TNF inhibitors and have the major share of the psoriasis market globally, are expected to have a lower market share in the APAC region due to the new launches and greater acceptance of biosimilars, especially in India and China", he said. "As cheaper biosimilar competitors enter the psoriasis treatment space, the sales revenues for these drugs will decline, hampering APAC market growth. However, the price of the biosimilar competitors is likely to be only slightly lower than that of the branded drugs", he added. ]]> <![CDATA[J&J partners with NYU School of Medicine]]> https://biospectrumindia.com/news/95/5017/jj-partners-with-nyu-school-of-medicine.html https://biospectrumindia.com/news/95/5017/jj-partners-with-nyu-school-of-medicine.html Fri, 08 May 2015 11:36:50 +0530 Johnson & Johnson (J&J) has announced a first-of-its-kind partnership that enlists a third party to review requests made to the Janssen Pharmaceutical Companies of Johnson & Johnson (Janssen) for compassionate use of its investigational medicines. This new approach will begin as a pilot program focused on a single Janssen investigational medicine and, if successful, will become a model that will be applicable more broadly across J&J. In keeping with the company's long-standing commitment to the highest standards of ethical decision-making that serves the needs of patients, Janssen Research & Development, LLC, has forged this new partnership with the Division of Medical Ethics at the NYU School of Medicine to obtain independent advice, further ensuring that the evaluation of requests for investigational medicines prior to their approval by the US Food and Drug Administration (US FDA) or other global health authorities are treated in the most fair and ethical manner. As part of this collaboration, the NYU School of Medicine will establish the Compassionate-Use Advisory Committee (CompAC), an external group of 10 internationally recognized medical experts, bioethicists and patient representatives to pilot the new approach. Commencing with one of Janssen's investigational medicines, the CompAC will make recommendations regarding individual patient requests from anywhere in the world. Investigational medicines are still in development and usually, limited in supply. The committee's careful consideration and recommendations based on its independent review will be passed on to Janssen's clinicians, who will make the final decision. The FDA describes compassionate use as "a pathway for patients to gain access to investigational drugs, biologics and medical devices for serious diseases or conditions. Such investigational drugs have not yet been approved by the FDA, and they have not been proven to be safe and effective." "We have a responsibility to patients and their families to ensure their well-being in everything we do. By ensuring compassionate use requests for our investigational medicines are evaluated by a well-informed, external committee, we can better weigh what we know about these therapies against the patient's condition and risk factors to make the most responsible decision for each patient," said Dr Amrit Ray, chief medical officer for Janssen Pharmaceutical Companies of Johnson & Johnson. For compassionate use requests, Janssen has a long-established single point of contact: all interested treating physicians can contact Janssen Medical Information (1-800-JANSSEN in the United States or janssenmedinfo@its.jnj.com). Physicians outside the US may contact the Janssen office in their country. Physicians are asked to provide information about the patient, that is then used to evaluate the request. If permitted by local authorities, Janssen typically establishes an expanded access program (EAP) for investigational medicines when a favorable benefit-risk profile has been reported in a pivotal trial and there is a viable regulatory path to approval confirmed with a health authority. The EAP can potentially allow the treatment to be made available to patients living with the same serious or life-threatening condition for which the medicine was originally studied and who have exhausted other treatment options. If patients do not qualify for an EAP or an existing clinical trial, their requests will be forwarded to CompAC. "Our goal is to ensure that compassionate use of specific investigational medicines still in development is guided by ethical principles, and that the selection process continues to be thorough, transparent and fair. Compassionate use decisions are incredibly challenging, and we readily acknowledge that the current allocation system remains a work in progress. This new initiative hopes to create a more robust model to help guide these decisions," said CompAC chairman Dr Art Caplan, director, Division of Medical Ethics at the NYU School of Medicine, and Dr William F and Dr Virginia Connolly Mitty, professor of Bioethics. Dr Caplan likens the CompAC to what the United Network for Organ Sharing (UNOS) has achieved with its allocation process. He said, "We want to establish a model that will create a structured policy of allocation based on equality, need and efficacy to ensure that the utility of our scarce resources are maximized. If successful, CompAC will serve as a model for others in industry and in government to follow." ]]> <![CDATA['We will launch a new product soon']]> https://biospectrumindia.com/news/95/6766/we-will-launch-a-new-product-soon.html https://biospectrumindia.com/news/95/6766/we-will-launch-a-new-product-soon.html Thu, 07 May 2015 16:54:05 +0530 Camson Bio Technologies, an agri-biotech company focused on biocides, biofertilizers and hybrid seeds, has demerged its business into two separate entities, Camson BioTech Limited (CBTL) and Camson Seeds Limited. The Camson Seeds will soon be listed in the stock market. "We have already completed 95 percent of the process. We have received approval from all the concerned authorities, only RoC from income tax department is remaining, which we will get it in a month and hopefully by June, it should legally be a separate entity," said Mr Santosh Nair, CEO, Camson Bio Technologies, speaking exclusively to BioSpectrum. The shareholding pattern of Camson Seeds will mirror the shareholding pattern of CBTL. Shares will be allotted in the ratio of 1:1 existing shareholders of CBTL will get one equity share of Camson Seeds for every share held in CBTL. Post demerger, the company will focus more on to its biocides business, which is driving the growth of the company. "Our biocides business has seen good growth over the years and have been driving the company in terms of cash flow. The industry has accepted our products that we started manufacturing. That's why it makes sense to make it a separate vertical and focus more on the business." The firm will soon launch a new product. "We will launch a new product, Natural Fertilizer, which is one of its kind. A fertilizer purely available in organic form. We are going through the last leg of the trial and test marketing," said Mr Nair. The company has filed patents for the same, both in India and globally. Speaking about the plans for the seed business, he said that the company is contemplating on various measures so as how to take it forward. "We are negotiating on how to drive a focused business, whether to acquire another seed company or get a good technology partner and so on." Currently, majority of its business comes from the Northern and Western regions and the company has plans to expand it to Southern region as well. ]]> <![CDATA[Immunization campaign gears up with 2nd round of Mission Indradhanush ]]> https://biospectrumindia.com/news/95/5659/immunization-campaign-gears-up-with-2nd-round-of-mission-indradhanush-.html https://biospectrumindia.com/news/95/5659/immunization-campaign-gears-up-with-2nd-round-of-mission-indradhanush-.html Thu, 07 May 2015 14:45:01 +0530 Exhibiting government's serious approach on the issue, the union health and family welfare minister, Mr JP Nadda tweeted early in the morning of May 07, "Committed to immunizing every child in the country. Happy to announce start of 2nd round of Mission Indradhanush from today in 201 districts. I thank all frontline workers for their hard work in making 1st round successful. More than 20.8 lakh children immunised in 1st round of Mission Indradhanush. I am hopeful of crossing this mark in the 2nd round." Earlier Mission Indradhanush was launched on December 26 by the health ministry to immunize children against seven preventable diseases. After completion of first round, the government is now continuing the 2nd round which will be followed by 3rd and fourth as well. Under this program, four special vaccination campaigns will be conducted between January and June 2015. 201 high focus districts that have nearly 50 percent of all unvaccinated or partially vaccinated children. The program aims to achieve full immunization coverage for all children by 2020. It expects to cover all those children who are either unvaccinated or are partially vaccinated against seven vaccine preventable diseases including diphtheria, whooping cough, tetanus, polio, tuberculosis, measles, and hepatitis B. 297 districts will be targeted for the second phase in the year 2015 Out of the 201 districts, 82 districts are in just four states of UP, Bihar, Madhya Pradesh and Rajasthan and nearly 25 percent of the unvaccinated or partially vaccinated children of India are in these 82 districts of 4 states. The ministry will be supported by WHO, UNICEF, Rotary International and other donor partners. ]]> <![CDATA[Teva sends hot letter to Mylan's board]]> https://biospectrumindia.com/news/95/5571/teva-sends-hot-letter-to-mylans-board.html https://biospectrumindia.com/news/95/5571/teva-sends-hot-letter-to-mylans-board.html Thu, 07 May 2015 14:34:02 +0530 Teva Pharmaceutical Industries announced that it has sent a letter to Mr Robert J Coury, executive chairman of the board of directors of Mylan NV, in response to its rejection letter of Teva's $40 billion buyout offer. The full text of the letter reads as follows: April 29, 2015 Robert J Coury Robert J Coury Executive Chairman c/o Mylan Inc. Mylan N.V. Robert J Coury Global Center Albany Gate, Darkes Lane 1000 Mylan Blvd. Potters Bar, Herts Canonsburg, PA 15317 EN6 1AG, United Kingdom Dear Robert: Given the constructive tenor of our meeting last Friday and subsequent dialogue, it was disappointing that your letter of April 27 adopted such a vastly divergent tone. Your letter paints a fundamentally distorted picture of Teva and ignores its rich heritage, unique culture, industry-leading achievements and contributions that have benefited patients and healthcare systems worldwide, while for years creating substantial long-term value for our stockholders. I firmly believe that our respective stakeholders do not support, or benefit from, mudslinging, mischaracterization, rehashing of history or selective presentation of facts. Instead, I would prefer to return the dialogue to the significant value creation opportunity that a combination of Teva and Mylan represents to the stockholders and other stakeholders of both our companies. My focus has been and will remain on Teva's deep commitment to consummating a transaction as soon as possible. To that end, we stand ready to engage with Mylan's Board of Directors in a constructive manner while continuing to pursue antitrust approvals and building upon the very positive interactions with Mylan and Teva stockholders to date. With that objective in mind, I would like to take the opportunity to briefly address a number of the points that were raised in your letter, and provide you with clarity on these issues so as to help avoid any further misunderstandings. Teva's proposal provides premium value for Mylan and its prospects Our cash and stock offer of $82.00 per share implies a total equity value for Mylan of approximately $43 billion. This provides your stockholders with a 48.3% premium to the unaffected Mylan stock price of $55.31 on March 10, 2015, after which there was widespread speculation of a transaction between Teva and Mylan. This same view of your unaffected price, and the implied premium in our offer, was publicly shared repeatedly byPerrigo, a company with an independent, and highly relevant, perspective on Mylan's value. Moreover, we note your willingness to cede substantial ownership of Mylan's equity toPerrigo stockholders at a substantial discount to our premium offer, let alone to your stated minimum price for engaging with us. Your increased offer for Perrigo today takes away even more economic value from your stockholders in attempting to pursue a transaction that is already challenged, financially and otherwise. Based on market prices, Wall Street research estimates, and a wide range of accepted valuation methodologies, our $82.00 per share offer represents extremely attractive, immediate value for Mylan stockholders. Rather than being "value and growth destructive" as you suggest, the consensus is that the combination of our companies will allow the Mylan and Teva stockholders to share in the profound value creation arising from the significant synergies and strategic fit inherent in this transaction. Summarily rejecting our offer which provides Mylan stockholders with such a significant premium is inconsistent with the responsibilities and obligations of your Board of Directors to Mylan's stakeholders. Antitrust is not a barrier to completion The characterizations of the antitrust issues in your letter considerably overstate the regulatory hurdles for a combination of Teva and Mylan, both in terms of scope and timing. As noted, Teva fully expects that the regulatory reviews of a Mylan acquisition can be completed in 2015. Further, Teva is confident it can meet the very same seven-month timing window Mylan laid out for its Perrigo offer. To this end, Teva filed for premerger notification under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 on April 22, 2015, and has likewise started the pre-notification process with the European Commission. Teva has a successful track record of timely clearances in similar situations. In each of our acquisitions of IVAX, Barr and Cephalon, we quickly agreed to necessary divestitures and other remedies and were able to close in less than six months. Further, we are confident that any potential divestitures would be manageable. Most of Mylan's drug products do not overlap with Teva's, and the majority of those that do overlap have a number of other competitors and should not raise antitrust issues. Teva is prepared to make the divestitures needed to secure clearances and is actively identifying both potential divestitures and potential acquirers for divested assets. More broadly, a combination of our two companies will leave over a dozen significant sellers of generic prescription drugs, in the face of a customer base that continues to consolidate and gain in power. Additionally, there are very few products sold by both Mylan and Teva that are on the FDA's "drug shortage" list, and where these overlaps do exist, we do not foresee meaningful regulatory issues given differences in dosage strengths and/or the number of other sellers that exist. In summary, Teva does not see regulatory clearances as a meaningful barrier to a transaction with Mylan, and we expect that the proposed transaction can be completed by year-end 2015. We are prepared to engage with you and your advisors to discuss our solutions and provide you with any clarity that you seek on this subject. Teva and Mylan's obviously strong cultural and strategic fit Your repeated references to an absence of "cultural fit" between our organizations are puzzling. Teva has a history of over 100 years and is widely-recognized as a leading global pioneer that literally created the generics market in the United States and brought this model to other markets, significantly benefiting patients and healthcare systems worldwide. We continue to be at the forefront of industry evolution having created a unique business model and culture combining robust generics and specialty capabilities. We have set the industry standards for others to follow. Leadership, innovation, entrepreneurship and modest conduct are in our DNA. We will continue to leverage them to further shape the industry in the future. This has translated into a total stockholder return (TSR)1 of over 1,600% over the last two decades, which is well in excess of three times that of the S&P 500 Index and underscores Teva's history of long-term value creation. We have over 43,000 employees and operate in 100 markets, as well as over 60 manufacturing sites around the world, including six sites and thousands of dedicated employees in India. For decades, this has included a substantial presence in the Netherlands, where our European and specialty business headquarters are based, with almost 1,000 employees in management, R&D and production positions. We are proud of our heritage as a global company with historical roots in Israel. We also have a rich history of successfully integrating large, global and diverse organizations from an operational, geographic and cultural perspective. Our leadership team is respectful of an acquired company's heritage and is focused on preserving each organization's core strengths, competencies and talent. We appreciate the value and importance of Mylan's heritage and intend to preserve it. Through our extensive interactions with Mylan and its people over the years, we believe that Mylan and Teva employees fundamentally share a devotion and deep passion to improve patients' lives by delivering to the world's population access to the broadest range of affordable, high-quality medicines. We are determined to capture the full potential value resulting from this transaction by having the best people from both companies working for a much stronger combined entity. Teva is meritocratic, fair and committed to identifying the best people and best assets across each company.The strategic fit is likewise compelling. The proposed combination of Teva and Mylan is fully consistent with our clearly articulated strategy to advance both our generics and specialty pharmaceutical businesses. The proposed combination will create an industry-leading company, well positioned to transform the global generics space and create a unique and differentiated business model, leveraging on its significant assets and capabilities in generics and specialty. The transaction is not about size for size's sake, but rather about the unparalleled strategic and financial fit of the two companies for the benefit of all stakeholders. The two companies' capabilities in product portfolios, complex technologies and marketing are highly complementary. Together, we will become more efficient, allowing us to generate significant value, penetrate new markets and develop new capabilities. The opportunities for substantial achievable cost synergies and tax savings are estimated to be approximately $2 billion annually and are expected to be largely achieved by the third anniversary of the closing of the transaction. In addition, the combination will position the combined company to be a world leader in positively impacting the patients and communities we serve by providing many more people around the world with affordable and more accessible treatments. Proven leadership team committed to creating value for all stakeholders Our Board of Directors and management team are fully aligned and are unanimously supportive of this transaction. Our leadership team, beginning with our executives and extending throughout our business, operations and scientific ranks, is among the best and well-respected in the industry. It is a truly global team, highly diverse and rich in experience in generics, specialty and other relevant industries. We are an organization that is committed to cost control and restraint at all levels of our organization. This includes our approach to executive pay and perquisites, which favors restraint and a pay-for-performance philosophy, a reflection of our fidelity to the interests of all stakeholders, and not just a select few. Teva has demonstrated recently that it is highly attentive to its stockholders' views on matters of business strategy and corporate governance and has made decisive and rapid changes to the composition and conduct of our Board of Directors. Headed by our new Chairman of the Board, Professor Yitzhak Peterburg, the Teva Board of Directors has been significantly transformed, adding experienced industry participants as truly independent directors, and enhancing the diversity, global perspective and breadth of experience of its membership. The Teva Board brings to the table a shared commitment to our company, our strategy and our stockholders, and a highly collaborative working relationship with the management team. We, like every company - including yours - have had issues and front-page "black-eyes" in the past. Our current leadership team has fully addressed these challenges and transformed Teva and it is now stronger than ever. For either of us to rehash incidents of bygone periods relating to organizations or individuals hardly does justice to our collective work improving the reputation of the generics industry and its high-quality products, nor does it advance the interests of either of our organizations as we evaluate this current and rare opportunity for future growth and value-creation as a combined company. Teva is well-positioned to maintain its leadership, drive growth and continue superior financial performance When I became CEO in 2014, I promised that our first order of business would be to strengthen our global leadership in generics while improving profitability, driving organic growth and delivering on the promise in our specialty pipeline. We have been successful in doing so, as was illustrated by our strong 2014 results. Our 2014 results demonstrated strong performance in our industry-leading generics business with significant growth in profitability and multiple product launches delivering$1.0 billion in incremental net revenues, and we expect even stronger results in 2015. In addition to our robust generics business, our specialty pipeline is poised to deliver significant value to stockholders and patients and diversify Teva's future revenues. Our pipeline currently includes 20 late-stage products. In 2019, we expect to generate $4.5 billion in incremental annual risk-adjusted revenues from new specialty product launches (excluding COPAXONE®) that have successfully started in 2014 and are on track in 2015 and onwards. We recently augmented our pipeline with the 2014 acquisition of Labrys which we believe will position Teva as the leader in addressing the vast unmet need for chronic and episodic migraine medicines, with therapies expected to reach patients starting in 2019. In March 2015, we also announced an agreement to acquire Auspex, which is expected to further enhance Teva's revenues by up to $800 million in 2019, strengthening our core central nervous system franchise with the addition of a portfolio of innovative treatments for movement disorders. We continue to manage the lifecycle of our COPAXONE® franchise, including the successful launch in the U.S. of COPAXONE® 40mg which has already achieved a 67% conversion rate, clearly highlighting the patient need and demand for this improved product offering, and successful and further upcoming launches in various EU countries and elsewhere. Through a combination of the strong growth outlook for our generics business, our ongoing cost optimization programs and our specialty pipeline, Teva will generate significant growth offsetting the anticipated decline of certain of our mature specialty franchises. Teva also has a strong track-record of achieving cost savings and operational improvements. We delivered $600 million in net cost reductions in 2014 and we are on track to generate$500 million and $250 million in net cost reductions in 2015 and 2016, respectively, for a total of over $1.35 billion in recurring net cost reductions. The market has recognized these achievements, with Teva's one and three-year total stockholder return (TSR), comprised of share price appreciation and our regular dividend, standing at 27% and 44%, respectively. Notably, since January 8, 2014, when my appointment as CEO was announced following which we began executing our current strategy, Teva's TSR was 53%, significantly outperforming the S&P 500 Index's 18% andS&P 500 - Pharmaceuticals Index's 29% returns during that period. Pathway forward I fully agree with you that it would have been preferable to have engaged in a private discussion to explore this transaction. However, you left us no choice but to make our proposal public after you publicly rejected a potential offer before it had even been made. It is hard to reconcile that preemptive rejection, your announcement of a firm offer for Perrigobefore your Board of Directors even responded to the Teva proposal and the tone of your letter to me with the proper exercise of fiduciary responsibilities under any legal or business framework. We are fully committed to pursuing this transaction and we believe the best path forward is constructive, good faith dialogue between our respective teams. We encourage you to put the best interests of your stakeholders first by engaging in productive negotiations with us. As I said when we met last Friday, we are prepared to present to your Board of Directors an overview of Teva and to address any questions your Board might have. We certainly hope that the Mylan Board of Directors chooses to engage constructively with us as soon as possible in order to reach agreement on a combination that offers an unparalleled opportunity for value-creation and many other benefits for our respective stockholders, customers, patients and employees. This is a message we are hearing from more and more stockholders of Teva and Mylan. Sincerely, /s/ Erez Vigodman Erez Vigodman President & CEO As previously announced on April 21, 2015, Teva has proposed to acquire Mylan for $82.00 per share, with the consideration to be comprised of approximately 50 percent cash and 50 percent stock. Teva's proposal for Mylan implies a total equity value of approximately $43 billion.The transaction would not be subject to a financing condition or require a Teva stockholder vote. Teva's proposal is contingent on Mylan not completing its proposed acquisition of Perrigo or any alternative transactions. Barclays and Greenhill & Co. are serving as financial advisors to Teva. Kirkland & Ellis LLPand Tulchinsky Stern Marciano Cohen Levitski & Co are serving as legal counsel to Teva, with De Brauw Blackstone Westbroek and Loyens & Loeff N.V. acting as legal advisors in the Netherlands. Reference/s: [1] All TSR data from Factset; dividends received are assumed to be reinvested ]]> <![CDATA[Biocon's biosimilars enter global Phase-3 trials]]> https://biospectrumindia.com/news/95/4317/biocons-biosimilars-enter-global-phase-3-trials.html https://biospectrumindia.com/news/95/4317/biocons-biosimilars-enter-global-phase-3-trials.html Thu, 07 May 2015 13:06:24 +0530 The partnership has a strong portfolio of generic insulin analogs and biosimilars including Monoclonal Antibodies (MAbs) and recombinant proteins at various stages of development. Biosimilars Two molecules Pegfilgrastim (PEG-G-CSF) and Adalimumab have entered global Phase-3 clinical trials. While the PEG-G-CSF trial is well underway the Adalimumab trial has been recently initiated, said the company in a statement. In addition, the Phase-3 global clinical trial for Trastuzumab is progressing in more than 100 sites around the world. An initial ROW focused Phase-3 trial for Bevacizumab is also underway, said Biocon. Generic Insulin Analogs Two global clinical trials for generic Insulin Glargine initiated in 2014, have also made significant progress. The patient recruitment for Type-1 diabetes study has been completed ahead of schedule, while the recruitment for Type-2 diabetes study is expected to be completed by July 2015, said company. Dr Arun Chandavarkar, CEO and JMD, Biocon, said, "The advancement of these programs in the clinic represents significant progress towards providing these high quality biologics to patients across the world. I am confident that, together with our partner Mylan, we can build a strong global presence in generic Insulin analogs and biosimilars like monoclonal antibodies and recombinant proteins to address the need for affordable access to these biologics." As part of a shared commitment to provide access to high-quality and affordable biopharmaceuticals, Biocon and Mylan have established a strong collaborative RnD partnership for both generic insulin analog products and a high-value portfolio of biosimilars for oncology and autoimmune indications. Biocon today has one of the largest generic insulin analogs and biosimilars portfolio in advanced stages of development with five molecules in Phase-3 clinical trials, viz. Glargine, Pegfilgrastim, Adalimumab, Bevacizumab and Trastuzumab. "As we move into FY16, we clearly see our biosimilar strategy playing out with greater clarity, credibility and traction visible across our portfolio of Biologics as they advance in clinical development. We continue to make investments in R&D as a strong future value driver for Biocon," the company said. ]]> <![CDATA[Global cell-based assays market to grow $15 bn by 2018]]> https://biospectrumindia.com/features/95/6508/global-cell-based-assays-market-to-grow-15-bn-by-2018.html https://biospectrumindia.com/features/95/6508/global-cell-based-assays-market-to-grow-15-bn-by-2018.html Wed, 06 May 2015 15:45:33 +0530 They can be used to study mechanisms of action such as receptor binding, receptor activation, cell signaling, ligand internalization, and subcellular localization. The cell-based assays market is segmented into reagents and assay kits, instrument, software, services. The global cell-based assays market is expected to grow approximately $15 billion by 2018 at a CAGR of 11 percent. North America reported largest market share, followed by Europe, and Asia is expected to be the fastest growing region for increasing investments in life science research, advancements in technology and drug discovery outsourcing. These cell-based assays are routinely used in drug discovery process, ADME and basic research to establish the potency and stability of a drug substance or product and are important in establishing safety and efficacy profiles for biopharmaceuticals. Increase in investments by pharmaceutical companies in drug discovery, replacement of in vivo toxicity testing by in vitro testing methods, adoption of cell assay based on high throughput assay (HTS) screening, low cost label-free technology, accurate results, preference over animal model and emergence of new technologies such as microfluidics are some of the major drivers," said Research and Markets, a market research firm. Whereas, intellectual property rights deprived innovation which hampered market growth. Emerging areas such as advancement in stem cell culture, induced pluripotent stem cells, 3D cell based assay, single-cell assay, need of toxicity screening are opportunistic factors, while complexity of HTS assay, assay standardization and validation are threats. Major players in cell-based assay market include BD Bioscience(US), Danaher Corporation (US), DiscoverRx (US), EMD Millipore (Germany), GE Healthcare (UK), Life Technologies Corporation (US), Perkin Elmer (US), Promega Corporation (US), Beckman Coulter Inc. (US), Sigma Aldrich (US), Caliper Lifesciences Inc. (US), Thermo Fisher Scientific Inc. (US), and Xenometrix AG (Switzerland). ]]> <![CDATA[Mylan's hot letter to Teva's $40 bn offer]]> https://biospectrumindia.com/news/95/4267/mylans-hot-letter-to-tevas-40-bn-offer.html https://biospectrumindia.com/news/95/4267/mylans-hot-letter-to-tevas-40-bn-offer.html Wed, 06 May 2015 14:17:09 +0530 April 27, 2015 Erez VigodmanChief Executive OfficerTeva Pharmaceutical Industries, Ltd.5 Basel St.P.O. Box 3190 Petach TikvaIsrael 49131 Dear Erez: First, let me say what a pleasure it was to meet you for the first time in New York last Friday. As we discussed, I was very disappointed by your decision to make your interest in Mylan public without first taking the time to speak to me or meet in person. As those who know me will attest, I always am willing to discuss opportunities to create value for Mylan's shareholders and other stakeholders, and although it was after-the-fact, I was happy to grant you the opportunity to meet with me in person to hear your rationale outlined in your letter dated April 21, 2015. During our meeting, we touched on Teva's many struggles throughout the last several years, including the approval of the first generic version of your flagship product Copaxone® (despite Teva's claims that an AB-rated generic would never be approved); the persistent turnover and turmoil amongst the Teva leadership and Board and the resulting strategic confusion; Teva's consistent underperformance in comparison to the market and our industry; and your increasing need to find new sources of future growth. As I am sure you are aware, Mylan's historical compound annual growth rates (CAGR) in terms of revenues and adjusted EBITDA from 2011-2014 are more than double Teva's. 1 Erez, you told me in our meeting that Teva is different now and the challenges and cultural issues you have faced previously were now in the past. You assured me that Teva's new Board and management team had brought a new approach to the way it does business. Yet, this change was not evident in the way you approached your interest in Mylan. Through your leadership, you had the opportunity to set the right tone, and show the world that there is a new Teva. Instead, you chose to approach Mylan in a way that demonstrates that the old Teva is very much still alive, which only continues to beg questions about Teva's credibility. In contrast, our engagement with Perrigo has been based on a long history of mutual respect and prior private discussions. My initial letter to Joe Papa was made public after we were advised to do so by outside counsel pursuant to legal requirements, and I personally informed Joe in advance of making the proposal public. For the sake of your current and future shareholders, employees, patients, customers, communities and other stakeholders, I do hope you find a way to eventually change Teva's culture and establish credibility in your business dealings. However, we do not wish to make Teva's problems Mylan's problems, or to inflict them on Mylan's shareholders and other stakeholders. This potential combination is clearly in no one's best interest. At the conclusion of our meeting, however, I committed to you that I would take to the Mylan Board your indication of interest and your Board's beliefs as expressed in your letter to me, and I stated that the Mylan Board would respond accordingly. Please find below that promised response. The Board of Directors of Mylan received and carefully reviewed your expression of interest and beliefs with the assistance of our financial advisor, Goldman, Sachs & Co., our legal counsel, Cravath, Swaine & Moore LLP, and our Dutch legal counsel, NautaDutilh N.V. Following thorough consideration, the Mylan Board unanimously rejected Teva's expression of interest after determining it does not satisfy any of the key criteria necessary to permit our Board to depart from our successful and longstanding standalone strategy, or be distracted from our pursuit of other value-creating initiatives, to consider engaging in discussions to sell Mylan. The Mylan Board of Directors has a very important fiduciary obligation under Dutch law to act in the best interests of the Company's shareholders, employees, patients, customers, communities and other stakeholders. The Board always has been open to considering any and all paths forward in that regard, and has recognized that under certain circumstances it is possible that pursuing a proposal contemplating the sale of Mylan could be in the best interests of Mylan's shareholders and other stakeholders. The Teva expression of interest, however, is not even close to qualifying as a proposal worth pursuing. The Mylan Board believes that transparency regarding its position is in the best interests of the Company and its important constituencies. For that reason, even though Mylan is not for sale, the Board has asked me to lay out the conditions that would need to be satisfied by a potential acquirer before Mylan's Board would be willing to consider any disruptions to our Company and its focused execution on our standalone strategy and enter into any discussions about the possibility of selling the Company. In reviewing these criteria, it should be clear to you and to your Board why Teva's expression of interest and its beliefs fall far short of convincing us to engage in any further discussions at this time. You should not view this explanation as a negotiating position or a counter-offer; it is neither. It is simply an explanation of the minimum criteria a proposal would need to satisfy before our Board would consider it worth pursuing. To be frank, given Teva's history and actions to date, it is implausible that Teva can realistically satisfy our minimum criteria as set forth below. 1.Valuation Mylan has created tremendous value for its shareholders over the long term. Our standalone story and opportunity are clear, and have been laid out consistently for our shareholders and other stakeholders. As you and your advisors are well aware, many transactions have taken place in our space, including several with lesser quality players and much more robust valuations than what you expressed. I believe that the grossly insufficient valuation you have presented can only be attributed to a lack of real commitment to pursuing this transaction. As we have communicated many times to the public, our shareholders and other stakeholders, our Board and management are not, and will never be, entrenched; however, that does not mean we will entertain offers that grossly undervalue our Company. Our Board will certainly not consider engaging in discussions to sell the Company unless the starting point of the discussions is significantly in excess of $100 per share. This valuation is consistent with a best-in-class asset such as Mylan and with one that has a strong foothold in India, which provides a highly competitive cost structure and a strong backbone for growth. Similar acquisitions in recent history in the specialty and generics industry that were transformational and included best-in-class assets with significant growth prospects have had an average LTM EBITDA multiple of approximately 20x. 2 Generic manufacturers with a large Indian component have had an even higher average multiple at approximately 25x.3 In stark contrast, your expression of interest values Mylan at approximately 16.6x EBITDA4. 2.Currency of Acquisition Consideration, Industrial Logic and Cultural Fit Acquisitions of public companies can come in the form of stock, cash or a mix of stock and cash. The willingness of the Mylan Board to entertain the inclusion of shares of a potential acquirer as the currency for an acquisition depends on the quality of the potential acquirer and its stock. If a potential acquirer is a strong company with a tried and tested leadership, strong growth prospects, a robust strategy for sustainable, long-term growth, complementary assets and a proven history of successful execution, then the Mylan Board would be open to the inclusion of stock as acquisition consideration. But, based on our evaluation, that is not the case here. Simply put, the Mylan Board has no interest in considering an expression of interest that, based on our evaluation of the factors below, requires Mylan shareholders to accept what we believe is low-quality and high-risk currency in the form of Teva shares in exchange for their higher-quality and lower-risk Mylan shares in a transaction that lacks sound industrial logic and is likely to be significantly value and growth destructive. As you well know, Teva faces the looming loss of significant revenue from the end of exclusivity for the Copaxone® franchise, and has seen years of consistent and significant underperformance, even while enjoying the benefits of Copaxone®. Further, Teva has faced a constantly changing and flip flopping strategy, rotating leadership, shareholder outrage and a flat to negative growth outlook. Acquiring a great company like Mylan would not fix a struggling Teva because of the lack of sound industrial logic for such a combination. It is clear that your proposed acquisition is in the pursuit of size, not strategy, and does not address the significant structural and other challenges to Teva's recovery. There is simply no ultimate benefit in the three core areas that we believe are essential to any transaction in our industry: geographic reach, portfolio diversification and capability expansion. Our geographic positions are largely the same and combining them would add significant complexity without adding meaningful exposure to new markets. Our portfolios carry substantial redundancy with thousands of overlapping products globally. Importantly, this overlap includes key pipeline products expected to drive growth in the near and long-term, including generic Advair®, generic Copaxone®, generic EpiPen® Auto-Injector and several biosimilar products. Further, Mylan and Teva bring each other little in terms of new capabilities. It is important to note that given the massive overlap between our companies, the synergizing of redundant or similar efforts and products will inherently have a major negative impact on the very growth prospects you are aiming to extract from Mylan. What will be left is a short-term financial pop and longer-term value erosion. Combining our two organizations to achieve growth requires more than just sorting through size and complexity. We believe that significant cultural differences would make the successful integration of the two companies nearly impossible. At Mylan, we have consistently set a clear strategic plan and we reward our employees for accomplishing our objectives. This is something we feel strongly has contributed to our consistent outperformance. On the other hand, Teva's underperformance has been directly attributed to its "dysfunctional" culture. In fact, one of your most vocal shareholders who has studied your company in-depth and knows your management team and Board very well stated explicitly to Reuters with respect to integrating culture that "Mylan would give Teva severe indigestion."5 This is only further exacerbated when examined globally. Mylan operates a complex and substantial business in India where more than 12,0006 of our employees reside, 21 manufacturing facilities are located,7 and a major R&D hub for our global business is positioned.8 Teva has a limited presence and experience in the country, and in fact has been disparaging about India's products and culture. In a Business Standard article entitled "Teva Execs Remark Creates Furor in Indian Pharma," a senior Teva officer was reported saying, "you would never sit on a plane if you thought that the parts were coming from a dodgy factory somewhere that you didn't know. So, why do we accept this for medicines?"9 Bringing Teva's "dysfunctional" culture to the region could disrupt the core of our business, result in the flight of key talent (in India and elsewhere), and meaningfully and adversely impact the results of the possible combination. This challenged culture at Teva is, we believe, a direct result of a Board of Directors that refuses to change, lacks adequate global pharmaceutical experience and consistently meddles in company operations. This is the same Board that was described as "like a nuthouse" by an investor in a Bloomberg article10. Since 2007, your Board has churned through three different Chief Executive Officers, running the only one with the global pharmaceutical experience, which we think is critical to the position, out of town within 18 months of being on the job. Any investor should be gravely concerned that an experienced lead executive could be dismissed over "slight differences" of opinion with the Board. We believe that these rapid changes in a short period of time have left the company with a complete lack of long-term strategic focus. While I recognize that you are fairly new to your position, I cannot ignore the fact that you were present on Teva's Board during some of the company's most turbulent and "dysfunctional" times. Ten years of acquisitions and a flip-flopping strategy have left Teva with a smattering of assets in specialty, generics, biotech and consumer. You claim to want to "redefine the generics industry," but what faith can we have that you have any clear vision for the industry at all? And how can investors be assured this "redefinition" will not be abandoned for yet another new strategy? Customers and partners already have voiced their concerns about Teva, given its culture and reputation, and indicated their lack of support for the possible combination. We also have serious concerns about Teva's ability to integrate and efficiently run a combined company, and deliver meaningful shareholder value. There is simply no track record for investors to find. A review of the facts offers a clear view why we believe Teva stock is unacceptable. â€¢ In the past three years Teva has underperformed peers and the S&P 500 index by 223% and 12%11, respectively. â€¢ Teva's growth prospects as outlined by analysts calls for a CAGR of revenue from 2015-2017 of (0.6)%12 and a CAGR of EBITDA in the same time period of 2.1%12. â€¢ The median analyst price target for Teva represents a 1.0%13 premium to its current stock price. Analysts have lowered EPS estimates for Teva by approximately 10% over the last two years12. â€¢ In the past three years, Teva's stock price has appreciated 42%, while Mylan's stock price has appreciated 247%11.Mylan, on the other hand, has delivered very strong performance:â€¢ Mylan has grown revenue at a CAGR of 9%14 in the past six years, adjusted EBITDA by 15%14 and adjusted diluted EPS by 28%14 over the same time period.â€¢ Our three-year annualized total shareholder return of 36.2%15 more than doubles the S&P 500 and beats the S&P 500 Pharmaceuticals average. Our one- and five-year total shareholder return numbers also beat both metrics.These numbers speak for themselves. With the pending loss of exclusivity for the Copaxone® franchise (also impacting the 40 mg), they will likely only get worse.16 Wall Street estimates show that this loss could result in more than $600 million in annual EBITDA impact. The bottom line is that it would not be sensible for the Mylan Board to consider an expression of interest for a business combination that would result in Mylan shareholders being forced to take stock of a poorly performing troubled company in a combination that lacks industrial logic and is a terrible cultural fit. 3.Regulatory Risk Mylan's Board would not be willing to consider a sale of the Company unless a potential acquirer agrees at the outset to bear the entire regulatory risk. The possibility of agreeing to sell the Company and then having the regulators block the transaction (see Time Warner Cable, whose transaction with Comcast was terminated just last week in light of significant regulatory concerns) is an unacceptable risk for our Company, shareholders, employees, patients, customers, our communities and other stakeholders, particularly given the strength of our platform and the positive trajectory of our Company. For this reason, before our Board would seriously consider a proposal to sell Mylan, the potential acquirer would need to agree to guarantee to the Board's satisfaction that the transaction would receive regulatory approval, regardless of what actions the potential acquirer will need to take in order to make that happen. No exceptions would be acceptable. Furthermore, the potential acquirer would need to commit that the deal would close and our shareholders would receive their consideration within a relatively short period. As a point of reference, our proposal to Perrigo contemplates "hell or high water" requirements, as well as a commitment to close within seven months. We do not believe that Teva could offer similar comfort. We continue to believe that our massive overlapping positions would create significant antitrust concerns, creating the need for meaningful value-destructive divestitures. Furthermore, we believe regulators will, and should, care not just about overlapping products but the significant concentration of manufacturing power and supply to the market, as well as pricing power and potential for drug shortages. Already a respected medical professional has commented that the combination is problematic.17 Despite your need to move quickly to attempt to salvage shareholder value at Teva, sorting through an issue as critically important as the price and supply of generic medicines will not be easy or fast. There are significant risks that regulators would block a combination of Mylan and Teva, and even if regulators were willing to approve the transaction, they would require significant divestitures. Despite this, Teva has not made a commitment to guarantee that it would obtain regulatory approval in connection with its expression of interest, and it has not indicated an acceptable deadline-or any deadline-by which it would do so. 4.Other Stakeholders The Mylan Board of Directors takes its fiduciary duties owed to all stakeholders under Dutch law very seriously. In fact one of the main reasons why Mylan chose to organize itself in the Netherlands is its remarkable similarity to Mylan's former domicile in Pennsylvania, which also has a long history of respecting the value of all stakeholders in addition to shareholders. Mylan has been extremely successful at creating shareholder value while at the same time maximizing the best interests of employees, customers, patients, our communities and our other stakeholders and pursuing the Company's mission to provide a broad range of affordable, high-quality medicine to the world population. Teva's expression of interest contains nothing indicating why a combination with Teva would be in the best interests of Mylan's employees, patients, customers, communities or other stakeholders. In fact, we believe that statements in the press attributed to Teva's team have indicated that Teva does not believe the interests of these stakeholders are important. We also were interested to read in your communications to your employees that your operations in Israel would be unaffected by a combination, reflecting your long history of refusing to take costs out of Israel at the expense of far more efficient operations and employment elsewhere. Mylan's Board would not engage in any proposal that the Board did not believe was in the best interests of its stakeholders. Teva's expression of interest, which contemplates significant synergies without saying where they will come from and involves a potential acquirer that has been widely viewed as dysfunctional and poorly run and that has consistently flip-flopped on strategy, is not in the best interests of any of our stakeholders or of Mylan's mission. Based on all of the foregoing, Mylan's Board unanimously decided to reject Teva's proposal. The proposal grossly undervalues Mylan, and it would require Mylan's shareholders to accept what we believe are low-quality Teva shares in exchange for their high-quality Mylan shares in a transaction that lacks industrial logic and carries significant global antitrust risk. Furthermore, it calls for two fundamentally different and conflicting cultures to be integrated under a Board and leadership team with absolutely no proven ability to deliver sustainable shareholder value. Simply put, Teva's expression of interest is not in the best interests of Mylan's shareholders, employees, patients, customers, communities and other stakeholders. As this letter demonstrates, we have a keen appreciation for the challenges you face. The Mylan Board wishes you the best in attempting to turn Teva around. Sincerely,Robert J CouryExecutive Chairman SOURCES AND BASES OF INFORMATION Sources and bases of information contained in the letter reproduced in this announcement can be found in the footnotes to that letter.1 Calculated based on Mylan and Teva SEC filings.2 Average LTM EBITDA multiple based on the following transactions: Pfizer's announced acquisition of Hospira (5-Feb-2015), Actavis' announced acquisition of Allergan (17-Nov-2014), Actavis' announced acquisition of Forest Laboratories (18-Feb-2014), Teva's announced acquisition of Barr Pharmaceuticals (18-Jul-2008), Fresenius' announced acquisition of APP (7-Jul-2008), Mylan's announced acquisition of Merck KGaA (12-May-2007) and Novator Partners' announced acquisition of Actavis (10-May-20107).3 Average LTM EBITDA multiple based on the following transactions: Sun Pharma's announced acquisition of Ranbaxy (6-Apr-2014), Mylan's announced acquisition of Strides Arcolab's Agila Specialties Injectables Unit (27-Feb-2013), Abbott Laboratories' announced acquisition of Piramal's Domestic Formulation Business (21-May-2010) and Daiichi Sankyo's announced acquisition of Ranbaxy (11-Jun-2008).4 Based on Mylan 2015 IBES forecast.5 Reuters, "Teva shares slide on generic Copaxone fears" - 19-April-20156 Internal Mylan figure7 Mylan factsheet on Mylan.com8 Mylan factsheet on Mylan.com9 Remarks made by Teva Europe's President and CEO, Gerald Van Odijk, while participating in the annual meeting of the European Association of Pharmaceutical Full-line Wholesalers (GIRP) inCannes in 2010 and as reported in the media: http://www.business-standard.com/article/companies/teva-exec-s-remark-creates-furore-in-indian-pharma-110062200080_1.html10 Bloomberg, "Teva Returns to Roots After Outside CEO Faces 'Nuthouse'" - 5-March-2014 11 Stock price appreciation based on performance from 24-Apr-2012 to 24-Apr-2015. Selected Peers includes: Actavis, Akorn, Endo, Jazz, Mallinckrodt, Perrigo and Valeant.12 Analyst estimates based on I/B/E/S median estimates as of April 24, 2015.13 Median analyst price target per Bloomberg as of 3-Apr-2015.14 Represents compound annual growth rate from 2008 to 2014 per Company SEC filings.15 Annualized total shareholder return based on month-end share price from 30-Mar-2012 to 31-Mar-2015.16 Goldman Sachs research report on Teva, "What to expect from 2015 guidance; increasing our estimates" - 2-Dec-2014.17 Reuters, "DEALTALK-Drug overlaps, shortages may complicate Teva bid for Mylan" - 24-April-2015 ]]> <![CDATA[Torrent to acquire Zyg Pharma ]]> https://biospectrumindia.com/news/95/6509/torrent-to-acquire-zyg-pharma-.html https://biospectrumindia.com/news/95/6509/torrent-to-acquire-zyg-pharma-.html Wed, 06 May 2015 12:31:34 +0530 Torrent Pharmaceuticals has announced that it has signed a share purchase agreement to acquire 100 percent stake in Zyg Pharma. Zyg Pharma is a part of the Encore Group and ispromoted by the Merchant family. Ithas been in the specialty pharmaceutical business for over 50 years. The manufacturing facility is located in Pithampur, (Indore) and is approved by various regulatory authorities including the US FDA, TGA Australia. The company has capabilities for on site development, analytical method development and QC laboratory with separate areas for chemical, instrumental and micro sections. In line with its strategy to diversify into new therapy segments, the acquisition will help Torrent to strengthen its position in niche dermatological segment especially in the developed markets like US and Europe. The company has been a manufacturing partner to several international companies in India and it has also build a successful international business through partners in regulated markets as well as in emerging markets. Torrent would fund the acquisition through internal accruals. The transaction has been approved by the Boards of Directors of both companies. The financial details of the transaction were not disclosed. The transaction closure is subject to customary closing conditions and requisite regulatory and other approvals, and is expected to close by August 2015. ]]> <![CDATA[BMG LABTECH updates its ACU]]> https://biospectrumindia.com/news/95/6381/bmg-labtech-updates-its-acu.html https://biospectrumindia.com/news/95/6381/bmg-labtech-updates-its-acu.html Wed, 06 May 2015 09:38:05 +0530 BMG LABTECH's Atmospheric Control Unit (ACU) is now entirely integrated into the reader control software. Carbon dioxide (CO2) and oxygen (O2) regulation can be easily managed via the intuitive and easy to understand user interface. Measurement results and gas concentrations curves are displayed together over the time. Equipped with the Atmospheric Control Unit the CLARIOstar is able to provide the physiological environment for any cell type. The microprocessor-controlled unit can regulate CO2 and O2 independently from 0.1 percent to 20 percent, making it unnecessary to use premixed gas cylinders to reproduce the specific physiological conditions needed for cell-based assays. The integration of the ACU into the reader control software allows users to effortlessly regulate the gas concentrations within the microplate reader chamber. The gas concentration data is recorded over the measurement time and displayed in the MARS Data Analysis Software. Measurement data calculations can be related to the gas concentrations. Changes of the gas concentration can be done at any point during the experiment, either manual or by software, and are shown together with the measurement results. Status messages like an empty gas cylinder are additionally shown in the software. Furthermore the Atmospheric Control Unit comes with a backlit LCD touchscreen which allows the controlling of the physiological conditions when the connected computer is not running. Utilizing the stand-alone mode, users have the possibility to define up to 10 user-presets and to see the gas concentration curves on the LCD display. In combination with CLARIOstar's extended temperature control and three different shaking options (orbital, double orbital, and linear), the ACU is able to provide the physiological environment for any cell type, making cell-based assays more biologically relevant. Within the German-engineered ACU, integrated gas pressure regulators allow for easy setup and independence of gas supply pressure. Pressure sensors combined with an acoustic alarm enable easy control of both gas supplies while superior valve gas control ensures minimal gas consumption. Accurate gas regulation is further guaranteed by the incorporated altitude correction feature. The CLARIOstar multimode microplate reader offers filter-like performance with advanced LVF Monochromators that provides increased sensitivity over conventional monochromators. The LVF Monochromators, along with filters and an UV/ Vis spectrometer can be used for a variety of applications in up to eight different detection modes, Fluorescence Intensity and FRET, Time-Resolved Fluorescence (TRF) and TR-FRET, Fluorescence Polarization/Anisotropy, AlphaScreen/AlphaLISA, Luminescence (flash and glow) and BRET, and spectrometer-based UV/Vis absorbance. ]]> <![CDATA[Glenmark Pharma receives tentative ANDA approval for Calcipotriene Cream]]> https://biospectrumindia.com/news/95/4718/glenmark-pharma-receives-tentative-anda-approval-for-calcipotriene-cream.html https://biospectrumindia.com/news/95/4718/glenmark-pharma-receives-tentative-anda-approval-for-calcipotriene-cream.html Tue, 05 May 2015 15:54:00 +0530 Glenmark Pharmaceuticals Inc., USA has been granted tentative approval by the United States Food & Drug Administration (U.S. FDA) for Calcipotriene Cream, 0.005%, the therapeutic equivalent of Dovonex Topical Cream, 0.005% of Leo Pharma A/S. Glenmark will market this product upon receiving final approval of its Calcipotriene Cream, 0.005% ANDA. The patents listed in the Orange Book for Dovonex Cream are scheduled to expire on June 9, 2015. ]]> <![CDATA[Mylan launches Gilead's Sovaldi Tablets in India]]> https://biospectrumindia.com/news/95/6757/mylan-launches-gileads-sovaldi-tablets-in-india.html https://biospectrumindia.com/news/95/6757/mylan-launches-gileads-sovaldi-tablets-in-india.html Tue, 05 May 2015 15:32:34 +0530 Mylan NV has announced that its subsidiary, Mylan Pharmaceuticals Private Limited, has launched Gilead Sciences' Sovaldi (sofosbuvir 400mg tablets) in India. Sovaldi is indicated for the treatment of chronic hepatitis C infection, a blood-borne infectious disease, as a component of a combination antiviral treatment regimen. It is estimated that approximately 12 million people are chronically infected with hepatitis C in India. In February 2015, Gilead appointed Mylan as its exclusive distributor of Sovaldi in India. Mylan's President Mr Rajiv Malik commented, "Mylan has a long-standing history of partnering with Gilead to tackle key public health issues in India and around the world, beginning with expanding access to high quality, affordable HIV/AIDS antiretrovirals and now extending our partnership to include hepatitis C treatments. We are proud to continue our work together with the launch of Sovaldi as it supports our joint commitment to meeting the unmet medical needs of patients in India." "We are pleased to bring this important therapeutic advance to patients living with hepatitis C in India. Today marks an important milestone in Gilead's ongoing effort to make its hepatitis C medicines accessible to as many patients, in as many places, as quickly as possible," said Mr Gregg Alton, executive vice-president, corporate and medical affairs, Gilead Sciences. Sovaldi is sold by Mylan's dedicated sales force as part of its Hepato Care segment. ]]> <![CDATA[Dr K VijayRaghavan inducted into prestigious US NAS ]]> https://biospectrumindia.com/news/95/6610/dr-k-vijayraghavan-inducted-into-prestigious-us-nas-.html https://biospectrumindia.com/news/95/6610/dr-k-vijayraghavan-inducted-into-prestigious-us-nas-.html Tue, 05 May 2015 14:09:28 +0530 Professor K VijayRaghavan, secretary, Department of Biotechnology (DBT) was formally inducted as a foreign associate of the US National Academy of Sciences (NAS) at a ceremony at Washington on April 28, 2015. He had been elected as a foreign associate of NAS last year for his distinguished and continuing achievements in original research. NAS's membership is a widely accepted mark of excellence in science and is considered one of the highest honours that a scientist can receive. The NAS membership totals approximately 2,250 members and nearly 440 foreign associates, of whom approximately 200 have received Nobel prizes. Professor Vijay Raghavan who was appointed as the secretary of DBT in January 2013, had been the director of the National Centre for Biological Sciences before that. He is a fellow of The Indian Science Academies, an Associate Member of the European Molecular Biology Organization and a Fellow of the Royal Society. He was awarded the 'Padma-Shri' in 2013, by the Government of India. He is AJC. Bose Fellow of the Department of Science and Technology. He gave the J.C. Bose Memorial Lecture at the Royal Society in 2010. He was awarded the inaugural Infosys Prize in Life Sciences 2009, The Shanti Swarup Bhatnagar Prize in 1998. Professor VijayRaghavan who was appointed as the Secretary, DBT, Government of India in January 2013, had been the director of the National Centre for Biological Sciences before that. He is a fellow of The Indian Science Academies, an Associate Member of the European Molecular Biology Organization and a Fellow of the Royal Society. He was awarded the 'Padma-Shri' in 2013, by the Government of India. He is A. J.C. Bose Fellow of the Department of Science and Technology. He gave the J.C. Bose Memorial Lecture at the Royal Society in 2010. He was awarded the inaugural Infosys Prize in Life Sciences 2009, The Shanti Swarup Bhatnagar Prize in 1998. Professor VijayRaghavan is on the Board of Governors of the Okinawa Institute of Science and Technology, on the Scientific Advisory Board of IFOM, Milan and of the Janelia Farm Research Campus of the Howard Hughes Medical Institute. He is a Senior Editor of eLife. His significant scientific contributions include study of neuronal circuits in the brain and motor system and in the development of muscles. He, along with his group used molecular markers to chart the development of muscles in the fruit fly Drosophila. They also dissected the specification of segment-identity through the action of Hox genes in the epidermis, the nervous system and in the muscles themselves, each in distinct steps of development. These and other studies have provided a comprehensive picture of the mechanisms of flight muscle development. They have also identified a stem-cell population that makes flight muscles. His team has contributed to the understanding of how stem cell lineages contribute to the development of the olfactory circuits in the antennal lobe of the fly and of the walking motor-circuit. They work on the motor system and muscles have now allowed the study of how the ability for coordinated locomotion emerges during development. NAS's prestigious membership is achieved by election; there is no membership application process. Although many names are suggested informally, only Academy members may submit formal nominations. Consideration of a candidate begins with his or her nomination, followed by an extensive and careful vetting process that results in a final ballot at the Academy's annual meeting in April each year. Currently, a maximum of 84 members may be elected annually. Members must be U.S. citizens; non-citizens are elected as foreign associates, with a maximum of 21 elected annually. ]]> <![CDATA[Should India find an opportunity in GAVI's proposed funding withdrawal ?]]> https://biospectrumindia.com/news/95/4342/should-india-find-an-opportunity-in-gavis-proposed-funding-withdrawal-.html https://biospectrumindia.com/news/95/4342/should-india-find-an-opportunity-in-gavis-proposed-funding-withdrawal-.html Mon, 04 May 2015 14:16:00 +0530 Mr Seth Berkley, chief executive of the GAVI Alliance is reported to have said that the leading vaccine initiative support organization is planning to reduce its role in immunization programs in India drastically. "India is now getting close to the threshold level, at which point we stop providing support. So, once a country crosses that level, they have five years time for GAVI support," he recently told a news publication, also adding that they are in talks with the government to decide the course of action for the next five years." It is important to note that India at the moment has not parked any separate funds for the huge immunization programs launched earlier and in the recent past. In fact our health allocation is a mere 1 percent of GDP of the country. The issue has been widely debated and all eyes are on the Modi government's real action in this regard. Therefore, the big question is how will India be able to drive its ambitious program to achieve immunity against key diseases without proper assessment of funding needs? While one can partially agree with certain viewpoints within the government about the availability of sufficient funds in its treasury, the reason of concern is again on specifics. Wouldn't it be wise to have a working arrangement between various state health ministries and that of union government to work on the modalities in a situation where the international support providers are withdrawing the field citing reasons that might not be completely true. The kind of expertise and technical provided by GAVI in past has been much appreciated and there is little doubt that its absence in next 5 years means that the shortcomings of state and central government's contribution to public health will have to be taken care of soon. While the GAVI's approved budget for India from 2000-2015 was $278.70 million, the other international group, the Global Fund to Fight AIDS, Tuberculosis and Malaria was $850 million (it has also announced the halt to any further funds). The withdrawal of such funds cannot be ignored yet it can serve as an action point for our health ministry to prepare for future. As world second largest populous country with 120 crore people and counting, India has to realize that there is no alternative to boosting its own health system. ]]> <![CDATA[Glenmark's psoriasis drug receives FDA approval]]> https://biospectrumindia.com/news/95/5979/glenmarks-psoriasis-drug-receives-fda-approval.html https://biospectrumindia.com/news/95/5979/glenmarks-psoriasis-drug-receives-fda-approval.html Mon, 04 May 2015 12:12:55 +0530 Glenmark Pharmaceuticals has been granted tentative approval by the United States Food & Drug Administration (US FDA) for Calcipotriene Cream, 0.005 percent, the therapeutic equivalent of Dovonex Topical Cream, 0.005 percent of Leo Pharma A/S. Dovonex is indicated for the treatment of plaque psoriasis. According to IMS Health sales data for the 12 month period ending March 2015, the Dovonex market achieved annual sales of approximately $92.8 million. Glenmark will market this product upon receiving final approval of its Calcipotriene Cream, 0.005 percent ANDA. The patents listed in the Orange Book for Dovonex Cream are scheduled to expire on June 9, 2015. The company's current portfolio consists of 97 products authorized for distribution in the US marketplace and 67 ANDA's pending approval with the US FDA. ]]> <![CDATA[Fortis to sell its Singapore unit]]> https://biospectrumindia.com/news/95/6516/fortis-to-sell-its-singapore-unit.html https://biospectrumindia.com/news/95/6516/fortis-to-sell-its-singapore-unit.html Mon, 04 May 2015 11:50:18 +0530 Fortis Healthcare has announced that it has agreed to sell its Singapore unit RadLink-Asia to Fullerton Healthcare group for $83.47 million (Rs 530 crore). The deal will be completed on or about May 12, informed the company. "The significant value that we have created in our international healthcare businesses is now being unlocked and will be ploughed back to strengthen our growth in India. The divestment of this last major international business is in line with our strategic decision to intensify our focus on our core hospital and diagnostics business in India," said Fortis Healthcare executive chairman Mr Malvinder Singh and executive vice-chairman Mr Shivinder Singh, in a joint statement. JP Morgan and Religare Capital Markets acted as financial advisors to Fortis for this transaction. ]]> <![CDATA[Post its exit from Ranbaxy, Daiichi to report losses in dollars ]]> https://biospectrumindia.com/news/95/4248/post-its-exit-from-ranbaxy-daiichi-to-report-losses-in-dollars-.html https://biospectrumindia.com/news/95/4248/post-its-exit-from-ranbaxy-daiichi-to-report-losses-in-dollars-.html Fri, 01 May 2015 09:30:00 +0530 After its board approved the share sale to exit India, Japanese drugmaker, Daiichi Sankyo sold its entire holding of 8.9 per cent in Sun Pharma on April, 28. This brought down curtains on the Japanese pharma company's entry into Indian market about seven years ago. In 2008, Daiichi acquired Ranbaxy at a significant premium to its then market value. The company bought majority stake in Ranbaxy through a $4.1 billion deal (around Rs 20,000 crore then). As was announced on March 25, 2015, in a release titled "Announcement Regarding Closure of Merger between Daiichi Sankyo subsidiary Ranbaxy and Sun Pharma," Daiichi received the shares of Sun Pharma following the completion of Sun Pharma's merger with Ranbaxy. "From the perspective of the improvement of corporate value, Daiichi Sankyo has performed a review of the Sun Pharma shares and reached a conclusion to sell the shares entirely or partially. After the sale, Daiichi Sankyo will not be a major shareholder of Sun Pharma. However, the existing business partnership with Sun Pharma will remain unchanged," said the statement from company. Daiichi also said it will make an announcement concerning the effect of any gain or loss on the sale of Sun Pharma shares when results of operations for the fiscal year ending in March 2015 are announced. However, in its statement to BSE, it has mentioned that it will book a loss on sales of investment securities of 46.2 billion yen under extraordinary losses in its non-consolidated financial results for fiscal 2015. The shares were sold through National Stock Exchange on April,28. Daiichi got Rs 20,026 crore ($3.18 billion) which is technically about the same amount it had invested in rupee terms. However, this would still mark a loss compared to the dollar investment value of Daiichi which had invested through a mix of stake purchase from previous promoters, preferential allotment and open offer, giving it 63.92 per cent stake in Ranbaxy. ]]> <![CDATA[Sun Pharma open for more acquisitions: Reports]]> https://biospectrumindia.com/news/95/6331/sun-pharma-open-for-more-acquisitions-reports.html https://biospectrumindia.com/news/95/6331/sun-pharma-open-for-more-acquisitions-reports.html Thu, 30 Apr 2015 14:13:47 +0530 As per reports, Sun Pharmaceuticals is willing to spend as much as $7 billion on further acquisitions, bankers familiar with the generic drugmaker's strategy said. The firm recently acquired Ranbaxy. This deal is biggest to date at $3.2 billion, has given India's biggest drugmaker sufficient scale in generics and emerging markets to think about its next step - beefing up expertise in higher margin products and gaining a bigger global presence. "What has changed after the Ranbaxy acquisition is that their ambition has grown and now they want to become a global company which is more innovation-oriented," a banker at a foreign bank familiar with Sun Pharma's plans told Reuters. Reportedly, Sun Pharma is now eyeing acquisitions in the U.S. and the Europe, with a focus on companies that manufacture biosimilars, the low cost products similar to biotech drugs, which are seeing a fast pickup in sales. ]]> <![CDATA[FDA priority review designation for AZ's Brilinta ]]> https://biospectrumindia.com/news/95/5693/fda-priority-review-designation-for-azs-brilinta-.html https://biospectrumindia.com/news/95/5693/fda-priority-review-designation-for-azs-brilinta-.html Thu, 30 Apr 2015 13:39:33 +0530 The US Food and Drug Administration (FDA) has accepted and granted Priority Review designation to AstraZeneca's Brilinta (ticagrelor) supplemental new drug application (sNDA) to treat patients with a history of heart attack. The sNDA is based on the results of the PEGASUS-TIMI 54 study, a large-scale outcomes trial in more than 21,000 patients that investigated ticagrelor tablets plus low dose aspirin, compared to placebo plus low dose aspirin, for the chronic secondary prevention of atherothrombotic events in patients who had experienced a heart attack one to three years prior to study enrolment. The Prescription Drug User Fee Act goal date will be in the third quarter of 2015. Elisabeth BjÃ¶rk, vice president, head of Cardiovascular and Metabolic Diseases, Global Medicines Development, said "Recent research has shown that one in five patients will have a further heart attack, stroke or cardiovascular death in the subsequent three years following a heart attack, even if they are event free after the first 12 months." "There is a clear need for treatment options beyond the current standard of care of aspirin for the long-term prevention of atherothrombotic cardiovascular events in patients with a history of myocardial infarction. Today's milestone reinforces the importance of investigating clinical questions that address unmet patient need and we look forward to working with the FDA as they review our submission." A Priority Review designation is granted to medicines that the FDA determines have the potential to provide significant improvements in the treatment, prevention or diagnosis of a disease. The PEGASUS TIMI-54 study was presented during the opening late-breaking clinical trial session of the American College of Cardiology's 64th annual Scientific Session and Expo on March 14, 2015, and was also simultaneously published in the New England Journal of Medicine. PEGASUS-TIMI 54 is part of AstraZeneca's PARTHENON programme. The PLATO study, involving over 18,000 patients, was the first study in the programme and is the basis on which ticagrelor has been approved in over 100 countries and included in 12 major ACS treatment guidelines globally. Further ongoing PARTHENON studies are assessing ticagrelor for the prevention of cardiovascular events in patients with peripheral arterial disease, ischaemic stroke or transient ischaemic attack, and in patients with diabetes and coronary atherosclerosis. Brilinta is a direct-acting, selective and reversibly binding P2Y12 receptor antagonist in a chemical class called cyclo-pentyl-triazolo-pyrimidines (CPTPs). Brilinta works by inhibiting platelet activation. Brilinta (90mg) is indicated to reduce the rate of thrombotic CV events in patients with ACS (unstable angina [UA], non-ST-elevation myocardial infarction [NSTEMI], or ST-elevation myocardial infarction [STEMI]). Brilinta has been shown to reduce the rate of a combined end point of CV death, MI, or stroke compared to clopidogrel. The difference between treatments was driven by CV death and MI with no difference in stroke. In patients treated with percutaneous coronary intervention, it also reduces the rate of stent thrombosis. PEGASUS-TIMI 54 (PrEvention with TicaGrelor of SecondAry Thrombotic Events in High-RiSk Patients with Prior AcUte Coronary Syndrome - Thrombolysis In Myocardial Infarction Study Group) is one of AstraZeneca's largest ever outcomes trials with more than 21,000 patients from over 1,100 sites in 31 countries in Europe, the Americas, Africa and Australia/Asia. The study assessed Brilinta (ticagrelor) tablets at either 60mg twice daily or 90mg twice daily plus low-dose aspirin for the secondary prevention of atherothrombotic events in patients who had experienced a heart attack one to three years prior to study start. The primary efficacy endpoint was a composite of cardiovascular (CV) death, myocardial infarction (MI) or stroke. It was conducted in collaboration with the Thrombolysis in Myocardial Infarction (TIMI) Study Group from Brigham and Women's Hospital (Boston, MA, USA). AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of cardiovascular, metabolic, respiratory, inflammation, autoimmune, oncology, infection and neuroscience diseases. ]]> <![CDATA[ABAP seeks nominations for awards in biotechnology]]> https://biospectrumindia.com/news/95/6003/abap-seeks-nominations-for-awards-in-biotechnology.html https://biospectrumindia.com/news/95/6003/abap-seeks-nominations-for-awards-in-biotechnology.html Thu, 30 Apr 2015 13:38:27 +0530 The nominations to The Association of Biotechnology and Pharmacy will be scrutinized and assessed by the duly constituted committee for all the awards. The winners of the award have to personally participate compulsorily in the 9th Annual Convention of Association of Biotechnology and Pharmacy and International Conference (ECBHE-2014) being held at KL University, Vaddeswaram, Guntur district, Andhra Pradesh, during 14-16 December, 2015 and need to give a talk on their research findings during the annual convention. ABAP has invited nominations for the following awards from the eligible talented people with proven track record and achievements on or before September 10, 2015 in the prescribed format. Life time achievement award in biotechnology: Dr Guruvayoorappan Chandrasekaran Oration Award Gold Medal was established by Dr C Guruvayoorappan, Mannarkkad, Kerala, for the outstanding scientist in the field of biotechnology. Life time Achievement Award in Pharmacy: Dr D Sarangapani Memorial Gold Medal was established by Prof.DVR Saigopal, Tirupathi, Andhra Pradesh, for the outstanding scientist in the field of Pharmacy and its related areas. Talented Industrial Biotechnologist Award: The Prathista Industries Limited Memorial Gold Medal was established by Prathista Research and Development Center, Hyderabad, India for outstanding young Scientist or Technocrat in the field of Industrial Biotechnology whose research having industrial relevance. BAP- Senior Scientist Awards: Three ABAP-Senior Scientist awards in different areas of Biotechnology and Pharmacy will be selected on the basis of their academic and professional experience and achievements in their career. The awardees were given with Sri Nannapaneni Bapaiah and Smt.Sarojini, Nidubrolu, Memorial Pharmacy Gold Medal established Prof.Bhaskara Jasti; Sri.Vege Venkata Krishna Rao and Smt Neelakanteswari, Peda Avutupalli Gold Medal established by Dr Raj Vege; and Sri Edupuganti Venkataramaiah and Smt.Padmavathi Memorial Gold Medals. The format of application can be downloaded from the website of association (www.abap.co.in). The application in triplicate should reach the General Secretary on or before September 10, 2015. ]]> <![CDATA[Biocon top line grows 15% in Q4 FY15]]> https://biospectrumindia.com/news/95/4270/biocon-top-line-grows-15-in-q4-fy15.html https://biospectrumindia.com/news/95/4270/biocon-top-line-grows-15-in-q4-fy15.html Thu, 30 Apr 2015 10:07:41 +0530 Biocon Ltd announced its Q4 and FY 15 financial results on April 29, 2015. The company has registered revenue of Rs 3143 crore for 12 month period with profit after tax of Rs 497 crore. The company recorded Rs 854 crore revnue in Q4 with Rs 201 crore net profit. In Q4, Syngene has posted its strongest quarterly performance to date recording sales of Rs.238 crore and delivering 27 percent growth YoY. Full year sales of Rs.823 Crore and YoY growth of 15% were supported by a second half performance that delivered 23% growth, said company. Commenting on the quarterly performance and highlights, Chairman and Managing Director, Kiran Mazumdar-Shaw stated, "Biocon closed the year with a stronger performance in Q4 on the back of a record quarterly performance by our Research Services subsidiary, Syngene and an improved performance of our Biopharma business. We also recognized exceptional income from the sale of shares of Syngene. As we move into FY16, we are clearly seeing our biosimilar strategy playing out with greater clarity, credibility and traction visible across our portfolio of Biologics as they advance in clinical development. We continue to make investments in R&D as a strong future value driver. The Malaysia insulins facility has been commissioned, which once qualified, should provide us the scale to increase our presence and penetration in emerging markets and then in developed markets." The Biopharmaceuticals segment grew 11% in Q4FY15 with revenues at Rs.592 Cr. Full year performance was 5% growth YoY at Rs.2237 Cr. Within this segment, we have the Biopharma business comprising small molecule API, generic formulations and biosimilars as well as the Branded Formulations business, said company release. The Biopharma business delivered Rs.493 crore in Q4. Full year revenues were Rs.1807 crore. Though Biopharma performance has been better in Q4, business growth continues to be impacted by time taken in redeploying sales from the MENA region to other geographies, reduced offtake of specialty API and capacity constraints in insulins, said company. The Malaysia insulins plant has been commissioned. We have initiated steps required to qualify the plant. Once these activities are concluded, we will seek necessary approvals from emerging market regulators before starting commercial supplies. Plant qualification for the developed markets will happen subsequently, in line with the progress of our global clinical trials and filing of marketing authorization applications, said company. The Branded Formulations business recorded revenues of Rs.98 Cr in Q4 FY15, registering a growth of 6% YoY. For FY15, the vertical grew 10% YoY to Rs.430 Cr. In our continued endeavor to develop ourselves as a specialty franchise, we continue to shed products as part of our portfolio rationalization plan while focusing our energies on key brands. This has impacted top-line growth, both in Q4 as well as the full year but has helped improve profitability of this vertical. Full year sales of CANMAb (trastuzumab) have been encouraging and this holds promise as we look to bringing more products from our biosimilar portfolio into the Indian market in the future. Our insulins portfolio continues to grow ahead of the covered market. We will be entering the disposable device segment in FY16, which should help further grow the domestic Insulin Glargine business, said Biocon in its press release. ]]> <![CDATA[Malaria vaccine may be available by October]]> https://biospectrumindia.com/news/95/4574/malaria-vaccine-may-be-available-by-october.html https://biospectrumindia.com/news/95/4574/malaria-vaccine-may-be-available-by-october.html Wed, 29 Apr 2015 15:37:00 +0530 The world's first malaria vaccine may be available by October, as the vaccine candidate (RTS,S/AS01) is the first to reach phase III clinical testing and is partially effective against the clinical disease in young African children up to four years after vaccination. The RTS,S/AS01 vaccine was developed for use in sub-Saharan Africa where malaria still kills around 1,300 children every day. There is currently no licensed vaccine against malaria anywhere in the world. The final trial data is published in The Lancet journal. The results suggest that the vaccine could prevent a substantial number of cases of clinical malaria, especially in areas of high transmission. Protection was prolonged by a booster dose, increasing the average number of cases prevented in both children and young infants. "Despite falling efficacy over time, there is still a clear benefit from RTS,S/AS01. An average 1,363 cases of clinical malaria were prevented over 4 years of follow-up for every 1,000 children vaccinated, and 1,774 cases in those who also received a booster shot. Over 3 years of follow-up, an average 558 cases were averted for every 1,000 infants vaccinated, and 983 cases in those also given a booster dose," said Mr Brian Greenwood, corresponding author and Professor of Clinical Tropical Medicine at London School of Hygiene and Tropical Medicine in the UK, in a statement. The phase 3 randomized trial enrolled 15,459 young infants (aged 6 to 12 weeks at first vaccination) and children (5 to 17 months at first vaccination) from 11 sites across seven sub-Saharan African countries (Burkina Faso, Gabon, Ghana, Kenya, Malawi,Mozambique and United Republic of Tanzania) with varying levels of malaria transmission. In 2014, initial phase III results at 18 months showed vaccine efficacy of about 46 percent against clinical malaria in children and around 27 percent among young infants. "The European Medicines Agency (EMA) will assess the quality, safety, and efficacy of the vaccine based on these final data. If the EMA gives a favourable opinion, WHO could recommend the use of RTS,S/AS01 as early as October this year. If licensed, RTS,S/AS01 would be the first licensed human vaccine against a parasitic disease," said Mr Greenwood. ]]> <![CDATA[Jubilant conferred Golden Peacock National Quality Award]]> https://biospectrumindia.com/news/95/6426/jubilant-conferred-golden-peacock-national-quality-award.html https://biospectrumindia.com/news/95/6426/jubilant-conferred-golden-peacock-national-quality-award.html Tue, 28 Apr 2015 14:28:09 +0530 Jubilant Life Sciences was recently conferred with the 'Golden Peacock National Quality Award-2015' in Dubai. The main theme of the summit was 'Leading 21st Century Organization through 'ICE'. The prestigious award was presented to Jubilant in the 'Chemicals and Pharmaceutical category' for consistent efforts in manufacturing quality products and continuously striving to bring quality improvements. His Highness Sheikh Nahyan bin Mubarak Al Nahyan, Minister of Culture, Youth and Community Development Govt. of UAE felicitated Mr CB Bhardwaj, Senior Vice President - Manufacturing (Unit Head-Gajraula), Jubilant Life Sciences in presence of various eminent personalities. Speaking at the occasion, Mr Shyamsundar Bang, executive director - Manufacturing & Supply Chain, Jubilant Life Sciences said, "Manufacturing is the foundation of our business and we bring with ourselves a rich heritage of over 36 years. For the last two decades, Jubilant has produced products which are globally competitive, which means products meeting global quality standards and expectations of customers in different parts of the world. At Jubilant, we are committed to continuous improvement to make quality products at an affordable cost." "The global recognition that has come in the form of us winning the 'Golden Peacock National Quality Award' for our Gajraula unit, the largest integrated Pyridine and its derivatives facility in the world, is a testimony of our manufacturing excellence and production strength. We continue to strive for more such recognitions and set benchmarks for future." ]]> <![CDATA[We stand with the people of Nepal: WHO]]> https://biospectrumindia.com/news/95/6364/we-stand-with-the-people-of-nepal-who.html https://biospectrumindia.com/news/95/6364/we-stand-with-the-people-of-nepal-who.html Tue, 28 Apr 2015 14:16:10 +0530 The World Health Organization this morning handed over four emergency health kits comprising of medicines and medical supplies and $175, 000 as the first tranche of emergency health funds to meet the immediate health needs of the earthquake affected people in Nepal. "Within hours of the tragedy, WHO disbursed medical supplies to cover the health needs of 40,000 people for three months. These supplies are in the form of inter-agency emergency health kits and were given to hospitals in Nepal treating the injured," WHO Southeast Asia regional director Dr Poonam Khetrapal Singh said. WHO also immediately made available $175,000 to the Ministry of Health and Population, Nepal, as the first tranche of South-East Asia Regional Health Emergency Fund (SEARHEF). The SEARHEF funds are aimed at meeting immediate financial needs and to fill critical gaps in the aftermath of a disaster. Simultaneously, WHO is supporting the Ministry of Health and Population, Nepal, to continue to assess the health needs of the affected people and the damage to health facilities. Senior officials from the WHO Regional office are in Kathmandu, to reinforce WHO Nepal Office's support to the Government of Nepal. Other than the injured, those rendered homeless by the earthquake and are in need of immediate support for regular public health services, water and sanitation and psycho social support to deal with the trauma caused by the tragedy. The WHO emergency kits disbursed include medicines, disposables and instruments. Each kit can meet the needs of 10,000 people for three months. Each kit has a basic and supplementary unit. The basic unit is intended for use by primary health care workers with limited training. It contains non-injectable drugs, medical supplies and some essential equipment, accompanied by simple treatment guidelines. Basic equipment also has a complete sterilization set and items to help provide for clean water at the health facility. The supplementary unit contains drugs, renewable supplies and equipment needed by doctors working in first- or second-referral health facilities. The kits, developed by WHO, can also be used for initial supply of primary health care facilities where the normal system of provision has broken down. Reiterating all possible support, Dr Singh said WHO stands with the people and the Government of Nepal in this hour of crisis and would do everything to save lives. ]]> <![CDATA[FDA grants fast track designation to genzyme]]> https://biospectrumindia.com/news/95/6392/fda-grants-fast-track-designation-to-genzyme.html https://biospectrumindia.com/news/95/6392/fda-grants-fast-track-designation-to-genzyme.html Tue, 28 Apr 2015 14:15:00 +0530 Fabry disease is a rare lysosomal storage disorder that results in abnormal tissue deposits of a particular fatty substance (called globotriaosylceramide, also referred to as GL-3 or Gb3) throughout the body. GZ/SAR402671 is a glucosylceramide synthase inhibitor that blocks the formation of glucosylceramide (GL-1), a key intermediate in the synthesis of GL-3. FDA's Fast Track Drug Development Program is designed to facilitate frequent interactions with the FDA review team to expedite the clinical development and review of a New Drug Application (NDA) for medicines with the potential to treat serious or life-threatening conditions and address unmet medical needs for such diseases or conditions. It also provides the opportunity to submit sections of an NDA on a rolling basis before a sponsor submits the complete application. Genzyme is currently enrolling patients in its phase 2a trial of GZ/SAR402671, and plans to enroll nine treatment-naÃ¯ve male adult patients with Fabry disease in this international, multicenter study. "Becoming a Fast Track Program is an important milestone and we appreciate this designation from FDA," said Genzyme's acting head of rare diseases, Dr Richard Peters. "We look forward to learning more about this small molecule, with the goal of providing more therapeutic options to the Fabry community as quickly as possible." ]]> <![CDATA[Deliberations on cryobiology brings bioscientists together ]]> https://biospectrumindia.com/news/95/6459/deliberations-on-cryobiology-brings-bioscientists-together-.html https://biospectrumindia.com/news/95/6459/deliberations-on-cryobiology-brings-bioscientists-together-.html Tue, 28 Apr 2015 11:35:51 +0530 A four-day International Conference on 'Low Temperature Science and Biotechnological Advances' began at New Delhi from 27th April. In his inaugural address Dr S Ayyappan, secretary, Department of Agricultural Research and Education (DARE) and director general, Indian Council for Agricultural Research (ICAR) mentioned it as a unique opportunity of having an international event on cryobiology for the first time in Asia to bring together the research leaders of diverse disciplines working on crops, veterinary, aquatic species, microbial biotechnology and medical sciences. The conference is being organised by ICAR-NBPGR and National Academy Agricultural Sciences, India in collaboration with Society for Low Temperature Biology (SLTB), UK and Royal Botanic Gardens (RBG), Kew, UK. Dr Maurizio Lambardi from National Research Council of Italy who is the immediate past chair of SLTB co-chaired the inaugural session. Prof. R B Singh, immediate past president, NAAS and Dr JS Sandhu (DDG, Crop science) gave their remarks as Guests of Honour. Prof. Hugh Pritchard, head, Seed Biology, RBG, Kew delivered the inaugural lecture entitled 'Plant cryopreservation: Scale, Scope and Hope'. Prof. Pritchard highlighted the importance and need of seed banking through global partnership. Dr KC Bansal, director, NBPGR and organising secretary and Dr Rekha Chaudhury, convenor, extended warm welcome and thanked the delegates for their participation. During conference, the session on "Stem Cells and Animal Tissue Biobanking", would be highly informative for medical doctors and researchers working on stem cells preservation and their therapeutic use. Medical doctors are also participating who would present their research work through lectures and posters. The Newspaper Drug Today Medical Times has already carried the news of this International Conference last month. There is a session on microbes as services of cryopreserved microbial cultures are essential for research for understanding the interactions between microbes and plants. There is immense metabolic diversity of the microorganisms and have varying intrinsic capacity to cope up with sudden osmotic and temperature stresses. Cryopreservation is a standard technique for different types of microbial preservation and it needs the use of cryoprotectants, different rates of freezing, etc. State-of- the art in optimization of preservation conditions would be analysed. Throughout the world most of the reputed microbial resource centers have adopted the cryopreservation technology. Using glycerol as a cryoprotectant, to date, over 4000 species belonging to 700 genera have been successfully cryo-preserved. A scientific dialogue on these aspects at the Conference would immensely benefit the researchers. The world's population is projected to be about 9.2 billion in 2050. This would be needed to be fed with sufficient and nutritious food. However, due to climate change agricultural production is not coping up. Abiotic stress factors such as heat, cold, drought represent key elements which retard the food production. Cold stress is a major environmental factor that limits the agricultural productivity of plants in hilly areas. Intensive discussions on these issues would be held during the conference. Under the field of Aquaculture, cryopreservation has been successfully achieved for sperm of many fish species mainly on commercially important ones. Advances in research on cryopreservation of oocytes and embryos of fish species are still in infancy and need discussion for additional studies. Low temperature biology in animal sciences especially related to endangered and threatened species is steadily gaining importance. These species are often difficult to breed both in captivity and under natural conditions. The preservation of valuable breeds using assisted reproductive technologies needs further studies and hence cryopreservation of biological materials from such species holds promise. ]]> <![CDATA[Ella Foundation's Ebola vaccine raises hopes ]]> https://biospectrumindia.com/news/95/4278/ella-foundations-ebola-vaccine-raises-hopes-.html https://biospectrumindia.com/news/95/4278/ella-foundations-ebola-vaccine-raises-hopes-.html Tue, 28 Apr 2015 10:05:00 +0530 Genome Valley-based Ella Foundation on April 27, 2015 announced the completion of preliminary studies on an Ebola vaccine. The vaccine candidate is a human adenovirus engineered to contain an optimized synthetic gene based on viruses from the 2014 Ebola outbreak. Its platform uses controlled production of the glycoprotein. The Ebola virus has a short ribbon-like structure, and contains a coat studded with a spike-like protein called the glycoprotein and immune responses against this protein can help protect against disease. Founded and funded by Dr Krishna Ella and Ms Suchitra Ella, Ella Foundation is among the two foundations from the Asian region which had the unique distinction of winning the Gates Foundation Grand Challenges Explorations (GCE) grant, an initiative funded by the Bill & Melinda Gates to foster innovation in global health research. Announcing the development Dr Krishna Ella, founder director of Ella Foundation said "we believe Innovation needs to be pursued and funneled into control strategies whenever appropriate. No nation can withstand sudden shocks, whether these come from a changing climate or a virus. Availability of a vaccine should help India in its preparedness to combat the disease in case the virus lands on our shores. It would also be useful to protect our healthcare and military aid workers to African nations and attain world-wide immunization goals." This program is an important step from Ella Foundation to support World Immunisation Goals. Applauding the world immunisation week initiated by WHO and observed in the last week of April every year, Dr Ella pointed out Childhood immunisation is one of the most efficient ways to protect the health of children, family, and community. It is among the most cost-effective public health measures that helps minimize disease burden. Currently, there are no drugs or vaccines for Ebola. Urgency was never felt until the disease reached epidemic proportions in 2014. Dr. Ella, says at this moment, animal experiments with the candidate vaccine have been completed, and these will be followed by pre-clinical toxicology and then clinical trials in humans. According to the World Health Organisation, Ebola Virus is a deadly, tenacious and unforgiving virus. Up to 90% of those who show symptoms of Ebola can die. The early warnings about the disease fatality were ignored until recently since it only affected a tiny part of Africa, and the total yearly deaths had never crossed 1000. The current outbreak has reportedly killed more than 10,000 out of over 25,000 cases. This is the first time it has been recorded outside central Africa. Ebola Vaccine Program initiated by Ella Foundation is an expression of solidarity and the pledge by the Prime Minister of India to help the West African nations with their fight against Ebola virus disease. Ella Foundation earlier helped Bharat Biotech to develop of H1N1 pandemic influenza in the early stage. Ella Foundation is a not-for-profit research organization with a mandate to contribute to diagnosis, control and prevention of infectious diseases in man and animals. The Foundation began research and development on Ebola vaccine early November 2014. ]]> <![CDATA[Health communication gets its due at CAHOCON 2015]]> https://biospectrumindia.com/news/95/6493/health-communication-gets-its-due-at-cahocon-2015.html https://biospectrumindia.com/news/95/6493/health-communication-gets-its-due-at-cahocon-2015.html Mon, 27 Apr 2015 16:29:08 +0530 Wolters Kluwer, a global market-leading information services company has launched their healthcare communication course at CAHOCON 2015, a recent path breaking conference in the Delhi attended by the country's leading doctors and healthcare professionals. Launched by Dr Devi Shetty, chairman and founder, Narayana Health, this unique course on communication was hosted at Lippincott Gurukul, an eLearning platform to cater to the educational and training needs of healthcare professionals such as doctors, nurses and healthworkers. Present on the occasion at the launch on April 25, were other healthcare dignitaries such as Dr Somil Nagpal, senior health specialist, South Asia Region, The World Bank, Dr Arati Verma, senior VP-Medical Quality, Max Healthcare, Dr Alexander Thomas, â€?executive director at Association of Healthcare Providers of India (AHPI) and Dr Girdhar Gyani, director general, AHPI. Speaking on the occasion, Mr Shireesh Sahai, CEO, Wolters Kluwer India, mentioned, "We are pleased to announce the launch of Lippincott Gurukul, an eLearning platform and first course on healthcare communication. Studies show that given a chance patients would speak about their problem for 55 seconds, but on average physicians interrupt 18 seconds into the interview. This online course is designed to develop a culture of smooth and effective communication in healthcare set-up. It is the first of its kind in India and has been developed in collaboration with the Consortia of Accredited Hospitals (CAHO) and Baptist Hospital, Bangalore. The course aims to improve communication in healthcare organizations and thereby directly impact patient safety and the quality of care delivered." Lippincott Gurukul's relevance and ease of access is undoubtedly superior to other traditional solutions in the market such as face to face workshops and books. It features 24x7 cloud-based learning, an easy-to-use learning management system and a robust administrative functionality to help the users monitor training and assess staff competency. The eLearning course "Healthcare Communication: For Better Care and Cure", has been curated with course material by industry experts from Baptist Hospital, Bangalore and is based on national training workshops on healthcare communication which have been endorsed by NABH, NBE, INC, AHPI and Govt. of Karnataka and the highly successful book, Communicate.Care. Cure by Dr Alex Thomas. Following a straight forward approach, it provides direct action steps to communicate effectively with colleagues, patients and patient's family. The course uses tools like story-based learning employing real-life examples from healthcare professionals, videos, animations, quizzes and assessments which make learning engaging. After completing the learning modules, the users can assess their competency using the inbuilt online tests. It removes the need to hold or attend expensive training conferences, as the content can be delivered straight to the learners. Certificates will be awarded from Lippincott Gurukul and CAHO. Dr Alex Thomas said "It is 30,000 times more likely for people to die because of medical errors than aviation errors and 60-70% of preventable medical errors occur as a result of poor communication. Effective communication in the hospital setting has a direct impact on patient safety and the quality of patient care. This is a high-quality course that aims to improve communication in the healthcare sector." Healthcare professionals and leading doctors present at CAHOCON 2015 were appreciative of Healthcare Communication and lauded Wolters Kluwer's efforts in developing timely and state of the art tools that are indispensable to ongoing professional development. ]]> <![CDATA[SeQuent Scientific announces Q4FY15 results]]> https://biospectrumindia.com/news/95/7380/sequent-scientific-announces-q4fy15-results.html https://biospectrumindia.com/news/95/7380/sequent-scientific-announces-q4fy15-results.html Mon, 27 Apr 2015 13:58:58 +0530 SeQuent Scientific, an integrated pharmaceutical company with business across animal health, niche human APIs & analytical services announced its financial results for the fourth quarter ended March 31, 2015 (Q4FY15) and full year ended March 31, 2015 (FY15). The company's operating revenue was Rs 133 crore as compared to Rs 107 crore in Q4FY14. Adjusted EBITDA stood at Rs 20 crore as compared to a loss of Rs 4 crore during the corresponding period of previous year. Net loss stood at Rs 19 crore for Q4FY15 as compared to a loss of Rs 80 crore in the corresponding period of the previous year. The operating revenue stood at Rs 465 crore as compared to Rs 455 crore in FY14. Net loss stood at Rs 12 crore as compared to a loss of Rs 110 crore in FY14. Commenting on the company's performance for FY15, Mr Manish Gupta, MD, SeQuent Scientific, said, "We are pleased that we could demonstrate tangible growth and improved operating margins in the last quarter of FY15, which we believe are the result of the strategic re-alignment undertaken by the company at the beginning of the year. All our corporate actions have now been completed and this augers well for our goal to move to profitability in the coming year" SeQuent has entered into a non-exclusive licensing agreement with Gilead Sciences to produce APIs of two chronic hepatitis C drugs - Sofosbuvir and Ledipasvir ]]> <![CDATA[BioSpectrum Exclusive: Can Cipla be the next target on Teva's to-do list?]]> https://biospectrumindia.com/features/95/7014/biospectrum-exclusive-can-cipla-be-the-next-target-on-tevas-to-do-list.html https://biospectrumindia.com/features/95/7014/biospectrum-exclusive-can-cipla-be-the-next-target-on-tevas-to-do-list.html Mon, 27 Apr 2015 13:20:43 +0530 In Jerusalem, it is 8:45AM on the morning of Tuesday, April 21, 2015, when Israeli pharma behemoth, Teva Pharmaceuticals, officially announced on its website, its proposal to acquire its long-time arch rival Mylan, a thriving global generics manufacturer. The big deal The new deal on the block has shaken the pharmaceutical industry worldwide since it would create a global generics powerhouse, with the combined Teva-Mylan entity having approximately $30 billion in pro forma 2014 annual sales, and boasting a pipeline of more than 400 pending generic drug applications at the US Food and Drug Administration (USFDA). "The combined entity would be well positioned to transform the global generics space and would be able to leverage its significantly more efficient and advanced infrastructure, with an enhanced scale, production network, end-to-end product portfolio, commercialization capabilities, and geographic reach," said Mr Gianfranco Zeppetelli, deals analyst, GlobalData, a global research and consulting firm. The bid has also initiated worries of a possible increase in the generic drug prices. Mylan is said to be the current US leader in the world's largest generics prescription market, recording a total revenues of $7.7 billion in the fiscal year (FY) 2014. The largest contributor to this is the popular EpiPen auto injector (epinephrine [INN]), an emergency treatment for anaphylaxis, which accounts for 18 percent of the company's generic sales. Through this deal, Teva would gain a significant stronghold in the US generics market and would further extend its global reach. If successful, the merged entity would benefit from the most advanced R&D capabilities in the generics industry, and can become the world's leading integrated API division, allowing it to focus on biosimilars, vaccines and respiratory products. Mr Zeppetelli pointed, "Many current respiratory active ingredients have a looming patent expiry and would allow generic companies to create new formulations with their own inhalers. Blockbuster anti-depressant Cymbalta is also on the verge of expiry and could be exploited as a potential generic drug." Teva in a statement said that the proposed merger would benefit from leading positions in multiple sclerosis, respiratory, pain, migraine, movement disorders and allergy therapeutics. Teva expects the proposed transaction to be complete by the end of 2015. Teva vs Perrigo vs Mylan During the beginning of April, Mylan voiced out its plan to buy Irish-based Perrigo for $29 billion, a manufacturer of private label over-the-counter (OTC) products. Teva was against Mylan's plan of buying the Irish company, since that would create a much bigger entity before it could swallow Mylan. "....This (Teva-Mylan) proposal is contingent on Mylan not completing its proposed acquisition of Perrigo or any other alternative transactions," Teva said. Perrigo ultimately rebuked Mylan's offer stating that the offer was too low for it to consider, making the situation more favorable for Teva's deal proposal. Impact on Indian collaborations Mylan's Indian subsidiary, in February 2015, entered into an agreement with Gilead Sciences to exclusively distribute its hepatitis C drug Sovaldi and Harvoni in India. The same month, Mylan entered into another deal with India-based Famy Care, acquiring its female health care businesses for $750 million. Two days after the Teva's deal became officially public, On April 23, 2015, Mylan's subsidiary launched generic Sofosbuvir 400 mg tablets under the brand name MyHep in India, used for treating hepatitis C. Since 2009, Biocon and Mylan have been partnering together in making portfolios of biosimilars and complex biologics. The dynamic duo have also been engaged in developing generic insulin drugs. In February 2013, both entered into another partnership, to develop Biocon's generic versions of three insulin analog products - Glargine (generic version of Sanofi's Lantus), Lispro (generic version of Eli Lilly's Humalog) and Aspart (generic version of Novo Nordisk's NovoLog), with Mylan having exclusive commercialization rights in the US, Canada, Australia, New Zealand, and the European Union (EU). In February 2014, Mylan in partnership with Biocon launched world's first trastuzumab biosimilar in India, Hertraz, which is the biosimilar version of Roche's Herceptin. On the other hand, Natco Pharma, signed a deal with Mylan in 2008 to license its glatiramer acetate pre-filled syringes, which is a generic version of Teva's Copaxone, used in treating multiple sclerosis (MS). Indian generic makers tight lipped Analyst Mr Zeppetelli believes that Indian companies, such as Biocon and Natco Pharma, could be under threat from Teva should the deal go through. When approached Biocon for a quick comment, the company failed to respond. Sun Pharma's spokesperson replied in an email saying, "We have no comments to offer." Natco Pharma's HQ in Hyderabad neither received calls nor responded to the email sent by BioSpectrum seeking a statement on the impact on its business as a result of the proposed deal. It is believed that Natco may seek out other partners if the proposed merger happens. "Teva's established standing in Europe, and Mylan's established standing in the US can only be favored by such a deal and it could drive Indian company products away, especially when these products have been having issues with the regulatory watchdogs in the European Medicines Agency (EMEA)," Mr Zeppetelli opined. Generic giant Dr Reddy's spokeswoman too declined to comment on the developments. The generic drug industry has been consolidating as a way of dealing with fewer blockbuster brand-name drugs to copy, rising competition from upstarts in India, and a pricing squeeze in Europe and other developed markets. Actavis will certainly have been alerted by the deal, as the proposed Teva-Mylan company would create an even bigger rival while also increasing competition in the generics market. Earlier Lupin told Live Mint, "......The deal would not only create the world's largest generic-drug manufacturer but would also very visibly alter the competitive landscape and market dynamics in key markets like the US and Europe." Why Mylan? Teva's top-selling multiple sclerosis drug, Copaxone, lost exclusivity earlier this year. Thanks to a court decision invalidating Teva's September 2015 patent. Mylan said that it was poised to launch its own versions, but Teva appealed to the Supreme Court, which agreed to hear its case. Teva also reminded the generics makers that if they launched, and the high court ruled against them, it could collect twice the company's sales in damages. So far, no generic has yet been launched. However, the reprieve will definitely end when the patent expires in September - if not sooner. Analysts believe that Mylan believes in a stand-alone strategy, which is one of the main reasons why the company has opposed Teva's move. "Its proposed acquisition of Perrigo represented a defensive play against a possible hostile takeover. The potential Teva-Mylan combination has been seen to be without sound industrial logic or cultural fit. There would be a significant overlap in the companies' businesses and there could be issues of anti-trust regulatory clearances," commented Mr Zeppetelli. On April 21, 2015, Mr Erez Vigodman, Teva's president and CEO addressed a letter to Mr Robert J Coury, executive chairman, Mylan, explaining how this deal would benefit Mylan's stakeholders. "This transaction is unique in what it accomplishes for Mylan stockholders: a meaningful upfront premium, significant and immediate cash consideration and liquidity, as well as ownership in a leading global pharmaceuticals company from which they can benefit from the upside created by our combination. These benefits are not available to Mylan stockholders in the proposed acquisition of Perrigo or its stand-alone strategy," it read. Teva's Indian target? If Teva's eyes were to fall on an Indian pharma company, analysts believe that a potential candidate would be Mumbai-based drugmaker Cipla, which could be a way of expanding Teva's reach to South America, as shown by Cipla's recent acquisition of Duomed Produtos Farmaceuticos, a two-year-old importer and distributor of pharma products in Brazil. ]]> <![CDATA[â€œChennai has become a major hub for the CRO industryâ€?]]> https://biospectrumindia.com/interviews/95/4487/chennai-has-become-a-major-hub-for-the-cro-industry.html https://biospectrumindia.com/interviews/95/4487/chennai-has-become-a-major-hub-for-the-cro-industry.html Mon, 27 Apr 2015 10:39:00 +0530 Could you give a brief outline of Quest's services?Quest Life Sciences is a clinical research organization. We specialize in the conduct of Bioequivalence/Bioavailability studies for the generic pharma industry. Besides we conduct Phase II to Phase IV clinical trials on patients in hospitals. Our major strength is technical support that we provide to the clients from IVIVC guidance to designing the protocol and implementation of the clinical trials. We have conducted nearly 1000 trials so far in a period of last 10 years. Has the company forayed into countries outside India?The biggest advantage of clinical trials in India is the vast pool of subjects, disease profiles and ability to induct volunteers or patients in the shortest possible time. This coupled with a scientific pool of highly qualified and experienced pharmaceutical scientist has made India the centre for clinical trials across the world. In effect every pharmaceutical company in the world has recognized India's capabilities and advantages. So naturally we are gradually expanding our operations all over the world. Currently we have offices or Resident Managers in the US, Moscow and Thailand. Our main target is the regulated market. We now see a huge opportunity even in Rest of the World (RoW) market. Rules are becoming stringent day-by-day. Some countries such as Mexico, Thailand, and Russia have made it mandatory that all the clinical trials and BE studies to be conducted in their respective countries only. Quest has recently acquired Fortis Clinical Research? What was the reason to choose Fortis and could you elaborate on the financial details of the transaction? Quest Life Sciences is indeed very happy to have been able to acquire the entire assets of FCRL. FCRL is one of the established CROs in India and having several regulatory approvals such as USFDA, MHRA UK, ANVISA, and EMEA GERMANY, to name a few. The promoters of FCRL are Mr Malvinder Singh and Mr Shivinder Singh, former major shareholders of Ranbaxy. When Sun Pharma acquired Ranbaxy, FCRL decided to hive off FCRL as it was run by them as an extension of Ranbaxy. The sale of FCRL assets come at the most opportune time for us when Quest Life Sciences is in the advanced stage of setting up a state-of-the-art CRO facility in Gujarat. Quest Life Sciences was able to save substantial in the acquisition of FCRL assets and put to use each and every capital item. In addition, Quest Life Sciences has taken over the regulatory services of FCRL. We are therefore getting not only the assets but also the goodwill of the FCRL clients. Is the company looking at foreign private equity funds? Quest Life Sciences is in the advanced stage of signing with an international private equity funds investment banker. How would you evaluate the Chennai CRO industry, its growth and how do you plan to carve a niche despite stiff competition in Chennai?Chennai has become one of the major hubs for the CRO industry and has made remarkable growth in the last 5 years. However, Quest Life Sciences has a unique advantage of having served several leading international clients and large Indian Multinationals. The professional team of Quest Life Sciences has by far the best credentials in terms of qualification, experience and with the strong regulatory updates. Quest Life Sciences is the only CRO situated in the Special Economic Zone (SEZ) of Chennai. In Chennai, what kind of drugs is most commonly evaluated in clinical trials and what is Quest's experience in serving the trials?The clinical trial industry broadly covers generic drugs for BA/BE studies. This includes, oncology, dermatology, cardiovascular, ophthalmology and biosimilar studies. Quest Life Sciences is India's US FDA-approved Contract Research Organization and among the top 10 CROs in India, which was established in 2004 in Chennai, India. Quest Life Sciences caters to the technical needs of pharmaceutical industries for the conduct of BA/BE studies, clinical trials, clinical data management, bioequivalence, oncology trials, phase I trials, regulatory submission to the global drug regulatory agencies. (By Anusha Ashwin) ]]> <![CDATA[Vyome Biosciences launches its first product ]]> https://biospectrumindia.com/news/95/5433/vyome-biosciences-launches-its-first-product-.html https://biospectrumindia.com/news/95/5433/vyome-biosciences-launches-its-first-product-.html Sun, 26 Apr 2015 09:31:00 +0530 Vyome Biosciences announces the launch of OLIQUE Hair Oil Potion, its first innovative products range for combating the problem of dandruff and hair fall. OLIQUE products area result of persistent innovation and research by a dedicated team of the best and international scientists and experts in the field of dermatology. Dandruff, a common skin condition affecting more than 50 percent of the adult population, is hard to treat and keeps recurring even after the treatment. "The wash-off products like ordinary shampoos, do not offer a long lasting solution to the patients. To counter this problem, Vyome has launched Olique, an innovative and first of its kind leave-on hair oil potion which provides a long lasting cure. Olique Hair Care range of products is specially formulated using a patented platform technology - Molecular Replacement Technology (MRT), which treats fungal diseases like dandruff," said Mr N Venkat, co-founder and CEO of Vyome Biosciences. Olique hair oil potion (VB-001) has been clinically proven for superiority and the the rigorous clinical research has shown 20 percent higher efficacy over the best anti-dandruff shampoo in the market. "I am delighted with the launch of the Anti dandruff and Anti hair fall Olique Hair Oil Potion. This is an important milestone as Vyome moves towards a successful commercialization of its products," said Dr Raghunath Mashelkar, Padma Vibhushan and chairman of Vyome's Board of Directors, expressing his happiness on the launch of the product. ]]> <![CDATA[Pipeline advancements and asset acquisitions fueled mid-cap biotech R&D]]> https://biospectrumindia.com/features/95/5655/pipeline-advancements-and-asset-acquisitions-fueled-mid-cap-biotech-rd.html https://biospectrumindia.com/features/95/5655/pipeline-advancements-and-asset-acquisitions-fueled-mid-cap-biotech-rd.html Sun, 26 Apr 2015 09:10:00 +0530 The combined spend on research and development (R&D) for the peer group of 35 mid-cap biotech companies increased by nearly US $2 billion to reach a total of $9.7 billion in 2014, primarily thanks to top spenders Regeneron and Vertex, says research and consulting firm GlobalData. The company's report states that Regeneron led the way with R&D expenses of US $860 million in 2013, with further analysis showing that Regeneron's R&D expenses grew by 47.9 percent year-to-year to $1.3 billion in 2014. According to Mr Adam Dion, GlobalData's senior industry analyst, this expenditure was boosted by an increase in clinical trial expenses, due to additional costs for studies of dupilumab, and REGN-1033, the company's antibody to myostatin (GDF8), which is in Phase II trials for undisclosed musculoskeletal disorders. Mr Dion commented: "Regeneron's R&D expenses also grew due to the fees for the regulatory submissions and marketing approvals for Eylea, which GlobalData forecasts to be the top-selling eye drug by 2016. "However, Regeneron's overall R&D cost burden was partly offset by the conclusion of the phase III trials of Eylea in wet age-related macular degeneration and macular edema following central retinal vein occlusion." The analyst adds that Vertex had the second largest R&D outlay among the peer group, spending $855.5 million in 2014, representing a 3 percent decrease from 2013. This resulted from the company completing the TRAFFIC and TRANSPORT clinical trials evaluating VX-809, a combination product of lumacaftor and ivacaftor for treating cystic fibrosis. Despite this, unexpectedly sharp rises in spending from Jazz and Alnylam helped to drive R&D in 2014. Mr Dion continued: "Jazz's 518 percent spike in R&D spend was the result of a $197 million surge of in-process R&D (IPR&D) expenses, due to the asset purchases of Aerial BioPharma and Sigma-Tau Pharmaceuticals. These purchases gave Jazz the rights to two promising drugs, namely JZP-110 for potentially treating aspects of narcolepsy and sleep apnea, and defibrotide, to prevent severe hepatic veno-occlusive disease in bone marrow transplant patients. "Meanwhile, Alnylam's R&D expenses soared by 266 percent to $411 million in 2014, up from $112.3 million during 2013. This increase in R&D spend resulted primarily from a $221 million IPR&D charge in connection with Alnylam's acquisition of Sirna Therapeutics' RNAi assets from Merck," the analyst concludes. ]]> <![CDATA[MSD retariates its commitment to address cervical cancer disease burden]]> https://biospectrumindia.com/news/95/6292/msd-retariates-its-commitment-to-address-cervical-cancer-disease-burden.html https://biospectrumindia.com/news/95/6292/msd-retariates-its-commitment-to-address-cervical-cancer-disease-burden.html Sat, 25 Apr 2015 09:08:00 +0530 As per the latest statement issed by MSD India on April, 21, the human papillomavirus ("HPV") types HPV 16 and HPV 18 cause approximately 70 percent of cervical cancers worldwide whereas in India it is 82.7 percent. As per MSD, its 'GARDASIL is the first vaccine for the prevention of cervical and other cancers caused by HPV type 6, 11, 16 and 18 and is a major contribution to public health. Since its first approval in 2006, GARDASIL has been approved by regulatory authorities for the prevention of diseases caused by HPV types 6, 11, 16 and 18 in more than 135 countries worldwide. More than 178 million doses of GARDASIL have been distributed worldwide since 2006. Pointing towards the global approvals, MSD goes on to mention, Leading international health organizations throughout the world including the World Health Organization (WHO), the United States Centers for Disease Control and Prevention (CDC), Health Canada, the European Medicines Agency (EMEA), the Australia Therapeutic Goods Administration (TGA), among others, recommend the use of Gardasil. Leading medical associations in India like IAP (Indian Academy of Pediatrics) and FOGSI (Federation of Obstetrics & Gynecological Societies of India) recommend prevention of Cervical Cancer through vaccination. It is important to mention here that serious charges have been levelled against 'Gardasil' by the civil society activists in India. They allege that the vacccine trials have lead to death of volunteers in certain tribal regions in India. MSD has denied such charges. There has been an ongoing case too on the issue in the country's highest judicial authority, Supreme Court where both sides are presenting their arguements. MSD seems to have touched the subject indirectly in its statement. "Nothing is more important to MSD than the safety of our medicines and vaccines. We are confident in the safety profile of GARDASIL which is the result of over 10 years of research and development. Before it was licensed, its safety and efficacy was established in clinical trials involving more than 25,000 individuals. Safety has continued to be evaluated in large postlicensure surveillance studies in approximately one million people. MSD has an extensive and ongoing safety-monitoring program. In addition, the US CDC and other leading health organizations closely monitor the safety of GARDASIL, as they do with other vaccines. MSD and leading health organizations throughout the world communicate about the safety of vaccines, including GARDASIL, on a regular basis," it said. Around the world, approximately 527,624 women develop cervical cancer (new cases) and 265,653 die from the disease each year. In India alone, about than 122,844 women are diagnosed with cervical cancer every year, accounting for one out of four of all cases diagnosed globally. Indeed, cervical cancer is the second most common cancer among women in India and every year 67,477 women die as a result. Only 2.6 percent of women in India between ages of 18-69yr receive screening every 3 years for cervical cancer. Cervical cancer spreads most often to nearby tissues in the pelvis or to lymph nodes. It may also spread to the lungs, liver or bones. ]]> <![CDATA[World Immunization Week: WHO urges renewed efforts]]> https://biospectrumindia.com/news/95/6116/world-immunization-week-who-urges-renewed-efforts.html https://biospectrumindia.com/news/95/6116/world-immunization-week-who-urges-renewed-efforts.html Fri, 24 Apr 2015 15:03:17 +0530 Dr Poonam Khetrapal Singh, regional director, WHO South-East Asia, in her message has called for ensuring equity with the lifesaving drugs. "Every year vaccination averts 2 to 3 million infant deaths globally from deadly diseases such as diphtheria, hepatitis B, measles, mumps, pertussis, polio and tetanus. Vaccines save lives, but 1 in 5 children, an estimated 21.8 million infants worldwide still miss out on basic vaccines. Of them, 9 million infants, more than one-third, live in WHO's South-East Asia Region," said Dr Khetrapal. Of the 40 million children born in the region every year, only about 75 percent get all three doses of diphtheria-pertussis-tetanus vaccines. Children miss out on measles vaccines. In 2013 about 26 percent of the global measles deaths, almost 38 000, occurred in countries in the Southeast Asia Region, 27,500 in India alone. Dr Singh mentioned further, "These grim statistics underscore the need to intensify efforts to protect children with lifesaving vaccines. We must close these immunization gaps. We must emulate lessons learnt from major public health wins, especially the polio eradication program, to reach the unreached - the underserved children living in remote areas and in deprived urban and other settings - to ensure equity with routine immunization vaccines." With concerted efforts, WHO South-East Asia aims at maternal and neonatal tetanus elimination this year, measles elimination and rubella and congenital rubella syndrome (CRS) control by 2020; sustaining the victory over polio until the disease is eradicated globally; increasing immunization coverage to > 90 percent at the national level and to > 80 percent at the district level with the three doses of diphtheria-pertussis-tetanus vaccine. ]]> <![CDATA[Syngene likely to go public this July]]> https://biospectrumindia.com/news/95/8304/syngene-likely-to-go-public-this-july.html https://biospectrumindia.com/news/95/8304/syngene-likely-to-go-public-this-july.html Fri, 24 Apr 2015 13:00:49 +0530 "The DRHP (Draft Red Herring Prospectus) is likely to be filed today," a Syngene spokesperson told Business Standard. Incorporated in 1993, Syngene offers integrated discovery and development services to pharma and biotech, agro-chemical as well as other industries. Recently in 2015, Clinigene International, a fully-owned subsidiary of Syngene, involved in drug discovery and development CRO, was incorporated into Syngene. ]]> <![CDATA[Mylan launches generic version of Sofosbuvir ]]> https://biospectrumindia.com/news/95/6096/mylan-launches-generic-version-of-sofosbuvir-.html https://biospectrumindia.com/news/95/6096/mylan-launches-generic-version-of-sofosbuvir-.html Fri, 24 Apr 2015 12:59:17 +0530 The product is indicated for the treatment of chronic hepatitis C, a blood-borne infectious disease that affects more than 100 million people in the developing world, including approximately 12 million people in India. In September 2014, Mylan entered into a licensing and technology transfer agreement with Gilead granting Mylan the non-exclusive rights to manufacture and distribute generic Sofosbuvir in 91 developing countries, including India. Mylan's president Mr Rajiv Malik said, "The launch of Mylan's MyHep offers hope to millions of hepatitis C patients in India who are in need of a high quality, effective and affordable treatment option. We look forward to bringing that same hope to millions of more hepatitis C patients as we expand access to MyHep in the developing world." MyHep is an important addition to Mylan's growing commercial business in India and is sold by Mylan's dedicated sales force as part of its hepato care segment. The company also offers four additional unique and innovative segments - critical care, HIV care, women's care and oncology. ]]> <![CDATA[Mission 2019: Modi govt accelerates TB control, aims elimination in 4 years ]]> https://biospectrumindia.com/news/95/6115/mission-2019-modi-govt-accelerates-tb-control-aims-elimination-in-4-years-.html https://biospectrumindia.com/news/95/6115/mission-2019-modi-govt-accelerates-tb-control-aims-elimination-in-4-years-.html Fri, 24 Apr 2015 10:49:54 +0530 The Union Minister for health and family welfare, Mr JP Nadda on April 23, while speaking at the launch of government's renewed program 'Call to Action for TB' stated that one of the biggest challenges faced by the TB Control Program is in reaching out to the TB patients.Minister announced that a toll-free number will be launched soon to reach out to all suspected TB patients for counseling and treatment. "In addition to this number, we will use mobile and other telecommunication tools in an innovative manner in this program," he added. Mr Nadda mentioned that the patients would be able to call on this toll free number for any support and information they seek regarding TB. Even a missed call will suffice, the Health Minister informed. Based on the call received, the ministry team will reach the person who had made the call, check his or her status of TB and ensure the person is covered in the programme to get correct diagnosis, free drugs, treatment and follow-up. Mr Nadda stated that to achieve the vision of TB Free India, the ministry will ensure 90 percent coverage of BCG under the Mission Indradhanush; reach out to the unreached; diagnose all TB cases within two weeks of symptoms and refer to the nearest public health center; employ extensive use of rapid diagnostic kits and active screening of high risk population; and ensure treatment completion. The Minister added that efforts will be made to match international cure rates for MDR and XDR TB. It is important to have a rigorous follow up of treatment and ensure free treatment at the doorsteps, he stated. "We will also encourage research in new drugs and new drug regimes in order to achieve better regimens with shorter duration", Mr Nadda stated, in addition to promoting indigenous development and manufacturing of diagnostic tests under the "Make in India" program. Emphasis will be laid on provision of comprehensive healthcare to TB patients. The ministry will also work out schemes to incentivize patients to help complete therapy, coordinate with other ministries to ensure linking of TB patients and their families to various welfare schemes of the Government so that the earning of these families increase to enable them to have nutritional support which will enhance the immunity status of each member of the family. Health secretary, Mr BP Sharma stated that despite the challenges, India has achieved significant success in its TB Control Program-nearly 2 crore patients have been cured and about 3.2 million lives have been saved. He stated that the "Call to Action" will prove to be catalytic in synergizing efforts of various stakeholders towards a common shared goal. Also present at the launch function were representatives of WHO, USAID, The Union, STOP TB Partnership, Global TB Program of WHO, the US Embassy and other stakeholders. ]]> <![CDATA[Social media usage by pharma cos on the rise: Ogilvy]]> https://biospectrumindia.com/news/95/6505/social-media-usage-by-pharma-cos-on-the-rise-ogilvy.html https://biospectrumindia.com/news/95/6505/social-media-usage-by-pharma-cos-on-the-rise-ogilvy.html Thu, 23 Apr 2015 14:27:56 +0530 A new report by Ogilvy Healthworld highlights who leads the way in integrated social media marketing The average number of tweets by pharma has gone up by 530 percent since 2013, and twitter followers have increased by nearly 300 percent, said Ogilvy's report. Pharma companies with the biggest communities aren't necessarily the most effective at engaging with their users and generating interest. Followers reward pharma companies who post frequently and engage continuously -- those that keep their networks fresh with regular updates have the highest interaction from the community. The report 'Connecting the Dots: Which Pharma Companies are Succeeding in the Social Media Space?' is the first of its kind to provide insights into which pharma companies are leading the way in integrated social media marketing strategies. The report reveals a small group of companies are 'connecting the dots' and leading the way in social media. They are providing useful content that is both relevant to their marketing objectives and audience needs. They are engaging with consumers, healthcare professionals and media consistently on all of their networks in a way that encourages followers to contribute to the conversation. The report also draws some conclusions on social media best practice. To succeed, pharma companies need to be brave and prepared to have honest and meaningful conversations about their brands. This involves developing strategies and mapping out potential scenarios with internal stakeholders to respond as quickly as possible to their followers, Ogilvy said. They should aim to provide content that is relevant to their audience also have a clear set of engagement guidelines to help manage difficult questions. "We know that some pharma companies have been cautious in their approach to social media, but our report clearly demonstrates a dramatic and successful increase in activity," said Ms Rebecca Canvin, social media manager, Ogilvy Healthworld. She further added, "Social media has changed the way pharma companies communicate -- it allows them to build corporate reputation and engage in genuine, meaningful conversations with audiences. For companies who want to stand out from the crowd it's time to be brave, get personal, educate and integrate social media into their wider marketing strategy." The data for the report was gathered by monitoring 10 of the most popular networks for 14 pharma companies across six categories: social presence, social network, community size, activity, engagement and activity. The profile of each company was reviewed for one week per month for three months during 2014 to ensure sufficient data was collected, said the company's release. ]]> <![CDATA[Are we building a sustainable tomorrow?]]> https://biospectrumindia.com/news/95/7340/are-we-building-a-sustainable-tomorrow.html https://biospectrumindia.com/news/95/7340/are-we-building-a-sustainable-tomorrow.html Wed, 22 Apr 2015 17:48:00 +0530 Earth Day is today and we at BioSpectrum want to join the rest of the world in celebrating and promoting the continued health of the planet and our fellow beings. This day offers us an opportunity to reflect on the Earth's condition and renew our association with the life sustainer as members of her family. From plants to humans, life is a food web and in a country like India where 70 percent of its economy is dependent on agriculture, it is important to understand the country's biotechnological advancements in the field and how it has contributed to the well-being of the planet and its people. For the past 15 years, the Indian agriculture department and public researchers have been pumping in huge investments in to genetic engineering of crops to make agriculture more sustainable and feed the growing population. The use of Bt-cotton in India has grown exponentially since its introduction more than a decade ago. India has recently became the number one exporter of cotton and the second largest producer of cotton in the world. Indian cotton seeds are used in many developing countries in South Asia. The country's private sector has generated affordable technologies for smart crop improvement, thereby providing affordable seeds not only to India but also to other developing countries. Several Indian public sector research organizations, indigenous industry players and joint ventures have developed a number of biotechnology derived seeds that can bring enormous advantage to Indian agriculture, specifically to small and marginal farmers and consumers. Farmers have found that the use of genetic engineering in agriculture helps in getting rid of weeds, improving soil health and water retention, reducing pesticide runoff, and greenhouse gas emissions. Biotechnology also helps in promoting energy security through biofuels and this helps in keeping the environment clean and eco-friendly. However, over the past five years, India has also become the center of anti-GM movement, threatening the advancement of biotech-led agriculture in the country. "Genetic engineering could be a threat to human and environmental health," Greenpeace International, an NGO mentions on its website. Biotech experts in the country opine that escalating protests over the last five years have turned the Indian clock in agriculture research, back by more than a decade. Researchers still await the approval of the Biotech Regulatory Authority of India Bill (BRAI) which lapsed in 2014. The BRAI bill if approved could have been a one-window approach for regulation of genetic engineering and biotechnology products. "The world needs biotechnology," said Mr Jon Entine, a journalist and founder of the Genetic Literacy Project,"And it will need it even more in 2050, when the population is projected to reach 9 billion." As the World celebrates Earth Day 2015, Indian agricultural researchers are still clueless about the fate of agri-biotech in the country. ]]> <![CDATA[Govt takes 'Make in India' campaign to pharma sector]]> https://biospectrumindia.com/news/95/6093/govt-takes-make-in-india-campaign-to-pharma-sector.html https://biospectrumindia.com/news/95/6093/govt-takes-make-in-india-campaign-to-pharma-sector.html Wed, 22 Apr 2015 14:27:45 +0530 The government has taken various measures to promote the 'Make in India' initiative in pharmaceutical sector. In this direction, it had constituted a Committee under the chairmanship of secretary, Department of Health Research. This was stated by the union minister of chemicals and fertilizers, Mr Ananth Kumar in the Lok Sabha on April 21, 2015. Mr Ananth Kumar added further, "The mandate of this Committee was to carefully study the whole issue of APIs of critical importance by identifying important APIs and then working out a package of interventions/concessions required to build domestic production capabilities and examine the cost implications." The minister assured that the recommendations by the Committee are being examined for formulation of a policy for promotion of manufacturing of bulk drugs" "The committee which has since submitted its recommendation has, inter-alia, recommended establishment of Mega Parks for APIs with common facilities such as common Effluent Treatments Plants (ETPs), Testing facilities, Captive Power Plants/assured power supply by state systems, Common Utilities/Services such as storage, testing laboratories, IPR management, designing etc., maintained by a separate Special Purpose Vehicles (SPV)," revealed Mr Kumar. ]]> <![CDATA['All medicines are essential']]> https://biospectrumindia.com/news/95/6091/all-medicines-are-essential.html https://biospectrumindia.com/news/95/6091/all-medicines-are-essential.html Wed, 22 Apr 2015 14:17:50 +0530 According to a report by the standing committee on Chemicals and Fertilisers tabled in Parliament, all medicines, including life saving drugs, should be available in the market at an affordable cost. The panel has recommended expanding the scope of price control to cover all medicines available in the country. Currently, drug price regulator National Pharmaceutical Pricing Authority (NPPA) has fixed the prices of 509 formulation packs based on National List of Essential Medicines. "The committee was surprised to know that all medicines are not listed in the National List of Essential Medicines (NLEM). The committee are of the view that all medicines are essential and is taken only when it is needed by the patient," said the report on the Department of Pharmaceuticals. The panel further said, in a statement, "All these medicines, including life saving drugs, should be available in the market at affordable cost. To keep this in view, the committee recommend that the scope of price control needs to be enlarged to make all the drugs available, especially life saving drugs, in all parts of the country." ]]> <![CDATA[Teva proposes to acquire Mylan ]]> https://biospectrumindia.com/news/95/6119/teva-proposes-to-acquire-mylan-.html https://biospectrumindia.com/news/95/6119/teva-proposes-to-acquire-mylan-.html Wed, 22 Apr 2015 12:54:31 +0530 Teva Pharmaceuticas has announced a proposal to acquire all of Mylan's outstanding shares in a transaction valued at $82.00 per Mylan share. The consideration will be comprised of approximately 50 percent cash and 50 percent stock. The Teva cash and stock proposal provides Mylan stockholders with a substantial premium and immediate cash value, as well as significant potential for future value creation through participation in a financially and commercially stronger company. Teva's proposal also provides Mylan stockholders with a more attractive alternative to the proposed acquisition of Perrigo as announced on April 8, 2015, as well as to Mylan on a standalone basis. Teva's proposal would provide Mylan stockholders with consideration representing a 37.7 percent premium to the stock price of Mylan on April 7, 2015, which is the last day of trading prior to Mylan's press release regarding its unsolicited proposal for Perrigo, and a 48.3 percent premium to the unaffected stock price of Mylan on March 10, 2015, which is the last day of trading prior to widespread speculation of a transaction between Teva and Mylan. "Our proposal is compelling for both Teva and Mylan stockholders and other stakeholders. Our proposal would provide Teva stockholders with very attractive strategic and financial benefits and Mylan stockholders with a substantial premium and immediate value for their shares, as well as the opportunity to participate in the significant upside potential of the combined company - one that would transform the global generics space and leverage it to hold a unique leadership position in the pharmaceutical industry. We have long respected Mylan's business, and we are confident that Mylan's Board of Directors and stockholders will agree that our proposal represents a significantly more attractive alternative for Mylan and its stockholders than Mylan's proposed acquisition of Perrigo," said Mr Erez Vigodman, president and CEO of Teva. He added, "Furthermore, this proposed transaction advances the best interests of all other stakeholders of Mylan. The combined company will continue to advance Mylan's vision of setting new standards in healthcare, and will enhance opportunities to provide the world population with access to the broadest range of affordable, high quality medicine. Importantly, employees would benefit from substantial opportunities for growth and development as part of a larger leading company. We look forward to a bright future for our employees and enhanced choice for our customers." The proposed combination of Teva and Mylan would create a leading company in the pharmaceutical industry, well positioned to transform the global generics space. The combined company would leverage its significantly more efficient and advanced infrastructure, with enhanced scale, production network, end-to-end product portfolio, commercialization capabilities and geographic reach. ]]> <![CDATA[Daiichi Sankyo to sell Sun Pharma shares]]> https://biospectrumindia.com/news/95/6366/daiichi-sankyo-to-sell-sun-pharma-shares.html https://biospectrumindia.com/news/95/6366/daiichi-sankyo-to-sell-sun-pharma-shares.html Wed, 22 Apr 2015 09:33:00 +0530 The board of directors of Japanese pharmaceutical giant Daiichi Sankyo Company Limited approved a resolution on April 20, 2015, to sell entire or part of its holding of India's leading pharmaceutical company Sun Pharmaceutical shares. The press release indicated that as announced previously on March 25, 2015 (Announcement Regarding Closure of Merger between Daiichi Sankyo Subsidiary Ranbaxy and Sun Pharma), Daiichi Sankyo received the shares of Sun Pharma following the completion of Sun Pharma's merger with Ranbaxy Laboratories. From the perspective of the improvement of corporate value, Daiichi Sankyo has performed a review of the Sun Pharma shares and reached a conclusion to sell the shares entirely or partially. After the sale, Daiichi Sankyo will not be a major shareholder of Sun Pharma. However, the existing business partnership with Sun Pharma will remain unchanged. The company plans to sell the shares on the Indian stock exchanges. Daiichi Sankyo will make an announcement concerning the effect of any gain or loss on the sale of Sun Pharma shares when results of operations for the fiscal year ending in March 2015 are announced ]]> <![CDATA[Five-year-old Curadev seals deal with biggie Roche]]> https://biospectrumindia.com/news/95/6731/five-year-old-curadev-seals-deal-with-biggie-roche.html https://biospectrumindia.com/news/95/6731/five-year-old-curadev-seals-deal-with-biggie-roche.html Tue, 21 Apr 2015 14:19:49 +0530 Under the terms of agreement, which includes a research collaboration with Roche's research and early development organization to further extend Curadev's findings, Curadev will receive an upfront payment of $25 million, and will be eligible to receive up to $530 million in milestone payments based on achievement of certain predetermined events and sales levels, as well as escalating royalties, potentially reaching double digits for the first product from the collaboration developed and commercialized by Roche. The agreement covers the development of the lead pre-clinical immune tolerance inhibitor and a research collaboration with Roche's research and early development organization to further explore the IDO and TDO pathways. Curadev would also be eligible for milestones and royalties on any additional products resulting from the research collaboration. Roche will fund future research, development, manufacturing and commercialization costs and will also provide additional research funding to Curadev for support of the research collaboration. IDO1 (indoleamine-2, 3-dioxygenase-1) and TDO (tryptophan-2, 3-dioxygenase) are enzymes that mediate cancer-induced immune suppression. This mechanism is exploited by tumor cells as well as certain type of immune cells, limiting the anti-tumor immune response. Dual inhibition of the IDO1 and TDO pathways promises to maintain the immune response, prevent local tumor immune escape and potentially avoid resistance to other immunotherapies when used in combination, and could lead to new treatment options for cancer patients. Curadev's preclinical lead-compound, a small-molecule that shows potent inhibition of the two rate-limiting enzymes in the tryptophan - to kynurenine metabolic pathways, has the potential for mono therapy as well as combination with Roche's broad oncology pipeline and portfolio. "We are very excited to be working with the global leader in oncology with their unrivalled expertise in clinical development," said Dr Arjun Surya, CSO, Curadev. "The collaboration acknowledges our focused research efforts on patient-critical drug targets that have yielded a drug candidate that could make a significant difference in the development of novel treatments for patients suffering from cancer." ]]> <![CDATA[Senior SC lawyer bats for rare genetic disorder patients ]]> https://biospectrumindia.com/news/95/6299/senior-sc-lawyer-bats-for-rare-genetic-disorder-patients-.html https://biospectrumindia.com/news/95/6299/senior-sc-lawyer-bats-for-rare-genetic-disorder-patients-.html Tue, 21 Apr 2015 12:19:36 +0530 I have raked up the issue of treating haemophilia patients at par with people having diasbilities earlier too in the Parliament and will continue to draw attention to such issues, mentioned Mrs Meenakshi Lekhi, senior supreme court lawyer & member of parliament, BJP at an event on April 17, 2015 in New Delhi. "While the patients suffering from haemophila who suffer from disabilities are denied disability certificate by the concerned authorities, they are also denied fitness certificate as it could land doctors into a soup," the BJP MP said while talking about haemophilia patients who have been denied justice so far. She added further, "Haemophilia can be an example for other diseases if taken on priority basis. From this diseases to sickle cell anemia, requires more efforts from the civil society and government." Mrs Lekhi also laid thrust on the research into such diseases. She offered her assistance in coordinating such efforts at IITs or other research institutes. "Pre marital genetic counselling is a good idea to know about the disease history," she said. The BJP MP from New Delhi constituency talked about the Swach Bharat Mission and the need to embark on preventive healthcare. "The mix of traditional curative healthcare and preventive diagnostic toools too could play an effective role in this," Mrs Lekhi concluded. ]]> <![CDATA[Health ministry, Gates Foundation discuss enhanced cooperation in health sector]]> https://biospectrumindia.com/news/95/6183/health-ministry-gates-foundation-discuss-enhanced-cooperation-in-health-sector.html https://biospectrumindia.com/news/95/6183/health-ministry-gates-foundation-discuss-enhanced-cooperation-in-health-sector.html Tue, 21 Apr 2015 12:16:36 +0530 In her meeting with the Union Minister for Health & Family Welfare Mr JP Nadda, Mrs Melinda Gates, co-chair of the Bill & Melinda Gates Foundation (BMGF), discussed various potential areas of enhanced collaboration in the health sector. The meeting took place in New Delhi on April 20, 2014. Issues pertaining to enhanced cooperation and active collaboration with the BMGF in terms of extending technical and logistic support in enhanced coverage through routine immunization and introduction of new vaccines such as Pentavalent vaccine, IPV, Measles Rubella (MR) vaccine and Rotavirus vaccine; IEC activities to enhance demand generation for health services; eliminating Kala Azar in the endemic states such as Bihar and Uttar Pradesh; support in controlling TB; and in the field of family planning in terms of planning, monitoring and evaluation were discussed during the meeting. The Health Minister expressed appreciation for the efforts and meaningful contribution of the BMGF in the health sector in some states. He stated that the deep involvement of the Foundation with various health issues is truly commendable. He pointed out that the Government is committed to a "Healthy India" and is making efforts towards improving health systems in the country particularly at the level of the primary health care centers. The BMGF is viewed as an 'active partner' in the efforts of the Ministry to meet its envisaged goals, the Health Minister said. Ms Gates expressed appreciation towards the efforts made for enhancing the immunisation coverage through the recently launched Mission Indradhanush. She stressed on improving healthcare systems in the country through evidence-based data support. Ms Gates stated that for the family planning programs to be effective in the country, women should be given a basket of choices to choose from. Similarly, it was important to ensure compliance with quality assurance guidelines. The progress made in the country in this regard was discussed. Present during the high level meeting were secretary (H&FW) Mr BP Sharma, senior officers of the Health Ministry and representatives of the Bill & Melinda Gates Foundation ]]> <![CDATA[Lupin launches Zaxine in Canada]]> https://biospectrumindia.com/news/95/7339/lupin-launches-zaxine-in-canada.html https://biospectrumindia.com/news/95/7339/lupin-launches-zaxine-in-canada.html Tue, 21 Apr 2015 12:05:00 +0530 Lupin announced that its Canadian subsidiary, Lupin PharmaCanada (collectively Lupin) has launched its first Brand product Zaxine, under a strategic licensing agreement with the North-Carolina-based GI specialty company Salix Pharmaceuticals. Zaxine 550mg (rifaximin) is a long term antibiotic treatment for adults living with hepatic encephalopathy (HE), a complication of liver disease (cirrhosis). The agreement grants Lupin exclusive rights to promote, distributeand market Zaxine in the Canada. HE can lead to a wide spectrum of mental and physical symptoms, including confusion, disruption in sleep patterns, personality changes and coma Zaxine 550mg has approved by Health Canada under priority review for the reduction in risk of overt HE recurrence in patients greater than or equal to 18 year of age. Lupin will promote the product to Hepatologists and Gastroenterologists through its own specialty sales force in Canada. Lupin is in the process of establishing its Canadian presence and the launch opens up growth opportunities for the future. Zaxine is a 'First-in-Class' treatment for HE that currently has limited options for long term treatment. Commenting on the launch, Ms Vinita Gupta, CEO, Lupin, said, "We are very excited with the expansion of Lupin's business into Canada given the opportunity we have, to create a brand presence with the launch of Zaxine. The launch demonstrates Lupin's commitment to grow its brand franchise in North America and bring meaningful products to patients in Canada." ]]> <![CDATA[Modi's Canada Visit: Health innovations in India to get Canadian funding]]> https://biospectrumindia.com/news/95/6182/modis-canada-visit-health-innovations-in-india-to-get-canadian-funding.html https://biospectrumindia.com/news/95/6182/modis-canada-visit-health-innovations-in-india-to-get-canadian-funding.html Mon, 20 Apr 2015 12:57:59 +0530 The health innovations funded by Cananda will be focusing on maternal, new born and child health and Visceral Leishmaniasis elimination. While maternal, newborn and child health is a major challenge for the Government of India and Canada's flagship development priority, India is one of the six countries that bear 90% of the global burden of Visceral Leishmaniasis. This was stated in the Joint statement issued by the two sides on the occasion of meetings of Prime Minister Mr Narendra Modi with the Canadian Prime Minister Mr Stephan Harper Welcoming the collaboration between Department of Biotechnology of his Ministry and Canada, Dr Harsh Vardhan, Union Minister for Science & Technology and Earth Sciences said, ''Developing affordable innovations to mitigate disease burden is a major challenge for India. Partnering Canada allows us to tap into our combined capacity and strength to find solutions for disease control and improved maternal and child care." The Minister of State for Science and Technology and Earth Sciences, Mr Y SChowdary added, "Innovation-driven technology development underpins sustainable and inclusive growth. To partner with Canada, a major hub for innovation and start-ups, provides the right stimulus at the right time for India's drive for equitable growth." "India has historic and close links with Canada in Science and Technology. Disease and poor nutrition affect early growth including the development of brains. Using our shared strengths to collaborate and address these problems will directly help the lives of many and also demonstrate ways of scaling such interventions to populations which need it most," said Dr K VijayRaghavan, secretary, Department of Biotechnology, Government of India. "Through Grand Challenges Canada, the Canadian government is supporting innovative solutions to global health problems for those who need it the most. These new bold ideas and renewed support for existing and scale-up innovations will make a difference in the lives of many people, including children," said Dr Peter A Singer, chief executive officer of Grand Challenges Canada. ]]> <![CDATA[Piramal to invest in a healthcare analytics firm]]> https://biospectrumindia.com/news/95/6226/piramal-to-invest-in-a-healthcare-analytics-firm.html https://biospectrumindia.com/news/95/6226/piramal-to-invest-in-a-healthcare-analytics-firm.html Mon, 20 Apr 2015 12:54:16 +0530 Piramal Enterprises has agreed to acquire a majority stake in Health SuperHiway over the next 12 months, the company said in a statement. As a part of the deal, Piramal has invested Rs 60 lakh in cash which will make it a minority shareholder in HealthHiway. According to the company, it will be investing up to an additional Rs 44.2 crore in the next 33 months, if HealthHiway achieves a set of specified growth milestones that are based on acquisition of hospital data partnerships. Upon the second tranche of investment, Piramal Enterprises will control a majority stake in the business, become the promoter, and assume operational control. "This investment, which will come in two tranches, continues Piramal's development of a global healthcare information business, which it began through its acquisition of Decision Resources Group in 2012, and its subsequent acquisitions of Abacus International and Relay Technology Management," the company said. Health SuperHiway is a healthcare analytics company promoted by Indian Hospitals Corporation which is owned by Apollo Hospitals Group founder chairman Mr Prathap C Reddy and his family members. ]]> <![CDATA[Temasek Holdings to invest in Glenmark]]> https://biospectrumindia.com/news/95/6231/temasek-holdings-to-invest-in-glenmark.html https://biospectrumindia.com/news/95/6231/temasek-holdings-to-invest-in-glenmark.html Mon, 20 Apr 2015 12:47:22 +0530 Glenmark Pharmaceuticals has informed the Bombay stock exchange that Temasek Holdings, the investment arm of the Singapore government, is considering investing in the company through its wholly owned subsidiary Aranda Investments, in equity shared to be issued by the company on a preferential basis. The company further said that it has decided to raise funds by way of issuance of upto 108,00,000 equity shares of Rs 1/- each on preferential basis for cash to Aranda, a foreign Portfolio investor, at a price of Rs 875 per equity share aggregating to Rs 945 crore, subject to requisite approvals of the shareholders and any regulatory authorities, as may be required. ]]> <![CDATA[We scaled back operations at our Mumbai R&D unit: Piramal]]> https://biospectrumindia.com/interviews/95/5164/we-scaled-back-operations-at-our-mumbai-rd-unit-piramal.html https://biospectrumindia.com/interviews/95/5164/we-scaled-back-operations-at-our-mumbai-rd-unit-piramal.html Sat, 18 Apr 2015 09:54:00 +0530 In his gripping interview with BioSpectrum's Raj Gunashekar, Mr Vivek Sharma, CEO-pharma solutions division, Piramal Enterprise, shares his exclusive views on the company's organic and inorganic growth plans, trends shaping up the industry, investments in new technologies, R&D cost pressures, and the impact of Mumbai R&D unit shut down last year. In January 2015, the company acquired US-based specialty pharmaceutical contract manufacturer, Coldstream, an eight-year-old organization with a focus on clinical trial to commercial-scale manufacturing of sterile liquid and lyophilized parenterals and injectables. Mr Sharma says that the contract manufacturing market for sterile injectables is expected to grow at an extremely fast rate. The CRAMS sector worldwide is highly fragmented, and is estimated to be growing at a CAGR of 7 percent. He reveals that the company has significantly invested in ADC (Antibody Drug Conjugate), a new technology. "ADC is an exciting technology which we believe has a lot of potential. However it remains a relatively new technology. Globally there are only two ADC products that have been commercialized. As more ADCs get commercialized, we would see significant growth in this segment, in both regulated markets and in emerging markets," he highlighted. "Our recent acquisition of Coldstream is a step towards enhancing our presence in this segment. Coldstream is a very high quality operation and has been able to build significant customer relationships and track record for sterile products. We see this as a great platform for growth in our pharma solutions business," he explains. He feels that this acquisition will allow Piramal Enterprise to move further into the injectables market segment and have a strong synergy with its existing pharma solutions business. Coldstream's use of isolator technology impressed Piramal, offering a foundation for expansion of the facility to provide large scale commercial manufacturing including production of highly potent compounds. Piramal's pharma solutions business is also on the lookout for investing in niche technologies. "Our acquisition of Coldstream was a step in this direction which gave us access to sterile injectables and differentiated expertise to formulate and manufacture high potency and cytotoxic compounds including ADC. We are also looking at technologies in the API (Active Pharmaceutical Ingredient) space that would enable us to handle cytotoxic compounds," he points. Globally, pharmaceutical companies are experiencing the effect of 'patent cliff'. A huge number of drugs will be going off patent soon. New launches are not able to make up for the loss of sales from drugs which are going off patent. "At the same time, R&D productivity as measured by average cost or new molecule entity, has been rising. In addition to this, raw material price increases and wage inflation is further adding to cost pressures. Finally, in regulated markets, we are also seeing a push towards generics from healthcare and insurance companies. These trends are translating into strong growth prospects for CRAMS providers, and we are optimistic that we are best positioned to leverage on this opportunity effectively," Mr Sharma summarizes while talking on the current happening trends in the pharma industry. As for the company, R&D is considered to be a key element in its strategy, "We continue to optimally invest in people and infrastructure to augment our R&D expertise," Mr Sharma remarks. For its pharma solutions business, North America and Europe have been its top performing markets and the company expects this trend to continue in 2015 as well. "CRAMS business centres around big pharma and emerging pharma companies based in North America and Europe. Our revenues therefore are expected to be centered on these geographies. However, we are a product centric business and are flexible enough to explore opportunities in emerging markets based on our customer requirements," he states. Mr Sharma observes that regulators globally are increasing the frequency and intensity of audits and inspections in a bid to ensure that pharma products are completely safe for end users. When asked about the company's growth plans, he stressed that the company remains committed to growing its business, both organically and inorganically, "Inorganically, we are always exploring niche buys as long as they provide us complimentary capability or give us a competitive advantage in the market place. We are increasingly being approached by companies with marketing capabilities to partner with them so as to leverage our leadership position, such as in ADC and formulations development. We are also looking to add capabilities in our API business. Whilst we scout for inorganic opportunities, we also remain confident of strong growth in our existing business and remain committed to making necessary investments to meet our goals," he comments. For now, Mr Sharma says that the company continues to remain optimistic about its entire pharma solutions business. "We have a broad set of offerings spanning from drug discovery & development to commercial manufacturing of off patent APIs and fixed dosage forms. We will continue to focus across these areas while investing in specialized services such as ADCs and biocatalysis. In Piramal Critical Care (PCC), we have significant market share in multiple geographies and we expect to grow further within this segment while expanding into related areas," voices Mr Sharma. Commenting on Piramal's Mumbai R&D unit shutdown in August 2014 and its impact on the business, Mr Sharma expresses, "We scaled back operations at our Mumbai R&D unit that was handling our own new chemical entities (NCEs). We continue to do development work for our customers in the CRAMS space. This move will actually benefit the business since it eliminates any apprehensions that customers may have with respect to conflicts of interest and IP (intellectual property) protection." ]]> <![CDATA[Half of world's haemophilia patients in India, experts seek govt's attention ]]> https://biospectrumindia.com/news/95/7334/half-of-worlds-haemophilia-patients-in-india-experts-seek-govts-attention-.html https://biospectrumindia.com/news/95/7334/half-of-worlds-haemophilia-patients-in-india-experts-seek-govts-attention-.html Fri, 17 Apr 2015 17:28:00 +0530 According to the survey conducted by the World Federation of Hemophilia in 2011-12, almost half of the world's Hemophilia population lives in India and around 70 percent of PwH do not have adequate knowledge or access to treatment. Thus, it remains a concern that the risk of death from lack of basic knowledge and untreated Hemophilia is very high in the country. Therefore, to mark the occasion of World Hemophilia Day on April 17, Hemophilia Federation (India) under the patronage of ministry of health and family welfare and National Health Mission, organized a sensitization programme on Hemophilia and its management at New Delhi. The program was aimed towards addressing Hemophilia as a disease and discussed the initiatives undertaken by the society and the government for treatment and management of this blood disorder. This event provided sensitization on the disease for policy makers; both at national and state level drawing references from Hemophilia management status in India vis a vis other developing countries. Ruling BJP's member of parilament, Mrs Meenakshi Lekhi was present as chief guest and Dr Jagdish Prasad, directorate general of health services was the guest of honor with Dr Majoj Jhalani, joint secretary, national policy, health ministry. The program kicked off with the welcome address by Dr Kanjaksha Ghosh, President, Hemophilia Federation India who talked about the state of Hemophilia in the country and the need of the hour to take appropriate initiatives in collaboration with the government. The programme drew participation from high profile personnel including all the state's Principal Secretaries of Health and the Mission Directors - NHM in addition to secretaries of the Ministry of Health and Family Welfare, Government of India. Discussing the current state of Hemophilia in India, Dr Kanjaksha Ghosh, President, Hemophilia Federation India said, "At present, only 15 percent of the total Hemophilia population has been identified in India and the rest lay undiagnosed. There are about 16,000 patients registered with Hemophilia in the country as yet, however, we suspect that the number of people suffering with Hemophilia in India could be ranging 7 times more than the current registered patients" The panel discussed the need to have a policy intervention for making diagnosis, screening and comprehensive care for Person with Hemophilia (PwH) more accessible. This can be achieved by developing more treatment centers equipped to handle PwH, increasing number of coagulation labs, training medical for practitioners and developing regional 'Centre of Excellence-Hemophilia Treatment Centres'.Talking about the disease management in Delhi region and his mission of 'One Country, One Treatment' that focusses on providing treatment to patients in their vicinity, Dr Naresh Gupta, head, Department of Medicine, LNJP Hospital said, "In Delhi, there are 2,000 registered patients suffering from Hemophilia and the state is also witnessing cases coming from other states as they do not have basic facilities and management care in their region. Through this initiative, we are proposing to build more treatment and care centers in regions which would create effective mechanism for diagnosis, treatment and bringing timely comprehensive care for Hemophiliacs within their reach" The program also witnessed sessions on Hemophilia disease in females, role of physiotherapy in reducing musculoskeletal morbidities among PwH in India, Government's intervention and role in addressing Hemophilia management. ]]> <![CDATA[Frontier Lifeline signs MoU with Russia to co-study genetic similarities in heart disease]]> https://biospectrumindia.com/news/95/6068/frontier-lifeline-signs-mou-with-russia-to-co-study-genetic-similarities-in-heart-disease.html https://biospectrumindia.com/news/95/6068/frontier-lifeline-signs-mou-with-russia-to-co-study-genetic-similarities-in-heart-disease.html Fri, 17 Apr 2015 14:15:00 +0530 Dr. K M Cherian's Frontier Lifeline Hospital in Chennai and The Institute for Atherosclerosis Research, Moscow, Russia, signed a collaborative research agreement to study the 'Genetic similarities causing heart diseases in Russians and Indians'. Sergey L Kotov, Consul General of the Russian Federation for South India, Prof Alexander Orekhov, Director, Institute for Atherosclerosis Research, Moscow, Dr Sanjay Cherian, Vice President of Frontier Lifeline Hospital, presided the press conference. Heart disease is the most common cause of death across the globe. Recent data shows that there is an increasing incidence of heart attacks both in India and Russia. In order to study the genetic similarities between Indians and Russians, Frontier Lifeline Hospitals and Institute of Atherosclerosis Research have initiated a scientific collaboration. Speaking on the collaboration, Sergey L Kotov, Consul General of the Russian Federation for South India, said, "This collaboration is a momentous occasion whereby two leading institutes from Russia and India are joining hands to study one of the biggest medical problems that both countries are facing today. The result of this research may benefit both Russians and Indians by identifying potential linkages between genetics and heart disease." "Under this partnership, Frontier Lifeline Hospital and The Institute of Atherosclerosis Research will jointly develop research projects, clinical studies, and strategies in the area of genetic similarities, collectively aimed at improving the quality of health and also to speed up the development of potential new therapies for patients with heart diseases," added Prof. Alexander Orekhov, Director, Institute for Atherosclerosis Research, Moscow. "Approximately 10% of heart diseases are due to genetic abnormalities. The present research is aimed at analyzing any genetic abnormality that may predispose to developing heart attacks by studying gene mutations in atherosclerosis. India and Russia have had several path-breaking collaborations in the past in the field of space and military technology. This formal MoU between India and Russia will be a grand step forward in the field of medical science and technology, since it will help us understand the genetic aspects of this complex disease and develop new treatment modalities to prevent heart attacks," expressed Dr Sanjay Cherian, Vice President of Frontier Lifeline Hospital. ]]> <![CDATA[Caplin Point Laboratories signs licensing agreements with UK and US pharma companies ]]> https://biospectrumindia.com/news/95/6374/caplin-point-laboratories-signs-licensing-agreements-with-uk-and-us-pharma-companies-.html https://biospectrumindia.com/news/95/6374/caplin-point-laboratories-signs-licensing-agreements-with-uk-and-us-pharma-companies-.html Fri, 17 Apr 2015 12:22:22 +0530 BSE-listed Caplin Point Laboratories, headquartered in Chennai, has signed a license and distribution agreement with Cycle Pharmaceuticals Limited, based out of Cambridge, UK. Under this agreement, Caplin Point will develop and manufacture identified liquid injectable products and Cycle Pharmaceuticals Limited will hold the ANDA and commercialize it in USA. Caplin Point Laboratories' Chairman, Mr. C C Paarthipan indicated that the agreement has been signed for a single product for the US market. Caplin Point has already received milestone payment for the product and the company has commenced a second product development cum dossier preparation. In another licensing agreement, Caplin Point Laboratories has entered into an agreement with Fresenius Kabi USA, LLC, a Delaware-based Limited Liability Company. Fresenius Kabi is claimed to be one of the leading global pharmaceutical companies with unique products and sharp focus on key geographies like USA and Europe. Under the agreement, Caplin Point will be responsible for developing and manufacturing two parenteral drugs and Fresenius Kabi will hold the ANDAs and will also commercialize them in the US. This is a product specific agreement for the United States of America. Caplin Point has received milestone payments for both the products and the product development cum dossier preparation have also commenced. ]]> <![CDATA[AZ, Immunocore partner for immunotherapy combo]]> https://biospectrumindia.com/news/95/6669/az-immunocore-partner-for-immunotherapy-combo.html https://biospectrumindia.com/news/95/6669/az-immunocore-partner-for-immunotherapy-combo.html Fri, 17 Apr 2015 10:57:11 +0530 AstraZeneca has announced that MedImmune, its global biologics research and development arm, has entered into a collaboration to conduct clinical trials in immuno-oncology with Immunocore, a privately-held UK-based biotechnology company. Under the terms of the agreement, Immunocore will conduct a Phase Ib/II clinical trial combining MedImmune's investigational checkpoint inhibitors MEDI4736 (anti-PD-L1) and/or tremelimumab (anti-CTLA-4) with IMCgp100, Immunocore's lead T-cell receptor-based investigational therapeutic, for the potential treatment of patients with metastatic melanoma. MedImmune has an exclusive relationship with Immunocore for the development of IMCgp100 in combination with MEDI4736 and/or tremelimumab, and will have first right of negotiation for future commercial development of these combinations for tumours expressing glycoprotein 100 (gp100), a tumour-associated antigen. Immunocore and MedImmune will establish a dosing regimen for IMCgp100 combined with MEDI4736 and/or tremelimumab within the Phase Ib study. The Phase II study will assess the safety and efficacy of the different combinations. The companies have a pre-existing research collaboration and licensing agreement, announced in January 2014, to develop novel cancer therapies using Immunocore's Immune Mobilising Monoclonal T-Cell Receptor Against Cancer (ImmTAC) technology. "We are pleased to expand our partnership with Immunocore, a leader in the discovery and development of novel T-cell receptor-based drugs, to include this combination clinical trial in melanoma. Immuno-oncology is a priority area for us and by employing combinations with biological synergies, we believe we have the potential to enhance treatment effectiveness and ultimately to see improved overall survival rates. Our partnership with Immunocore is further evidence of our belief that combination therapies have the potential to be one of the most effective ways of treating cancer," said Dr Ed Bradley, senior vice-president and head of the oncology innovative medicines unit at MedImmune. "We are excited to deepen our relationship with MedImmune through this combination study agreement. We look forward to a successful partnership in the development of novel combination treatments in metastatic melanoma, which we believe have the potential to be best-in-class treatments," said Mr Eliot Forster, CEO, Immunocore. MEDI4736, tremelimumab and IMCgp100 are members of a new class of cancer treatments known as immunotherapies, which are designed to enhance the body's own immune system in fighting cancer. ]]> <![CDATA[NCR companies seek govt's attention for fueling their biotech aspirations]]> https://biospectrumindia.com/news/95/5924/ncr-companies-seek-govts-attention-for-fueling-their-biotech-aspirations.html https://biospectrumindia.com/news/95/5924/ncr-companies-seek-govts-attention-for-fueling-their-biotech-aspirations.html Fri, 17 Apr 2015 09:00:00 +0530 In a much asked for initiative, BioSpectrum renewed its industry connect events from the first half of 2015. The first one was the CEO Conclave held in Delhi on March 10, 2015. The theme of the Round Table discussion attended by the representatives of all the major industry verticals was 'BUDGET 2015: Biotech Industry's Destiny Forward.' In his opening remarks, Mr Narayanan Suresh, Group Editor, BioSpectrum welcomed the participants and asked them to voice their free opinions on the budget. He remarked that the potential in the industry is yet to be tapped as the government hasn't given any special attention to it so far. "Government should clarify on the broad allocations made in the budget," said Mr Suresh. Present on the occasion, Mr Jagdish Patankar, managing director, MM Activ Sci-Tech Communications mentioned that the BioSpectrum has always been a watchdog for the industry and has supported its cause for the betterment of nation. "Industry should be forthcoming with its expectations," he added. First to speak from industry, Dr Jitendra Verma, managing director, Life Care Innovations, opined, "Start-ups and MSMEs need higher level of financial support for both pre-clinical and clinical development of biopharma products. To encourage entrepreneurship, it would immensely help to create insurance schemes in case a young entrepreneur fails in their endeavour. Such insurance schemes can be created with adequate safeguard to minimise abuse." As per Mr Pankaj Sharma, chief executive officer, LeadInvent, "Industry must introspect why the big companies are shutting their businesses in India. He added, "If the big boys are not doing it then let the innovation come from start ups." Raising the issue of lack of infrastructure, he also said that large animal studies difficult to do in India and also the radio chemistry studies are at a standstill due to unclear policy. Voicing his opinion, Mr Sushant Bakhru, director, Biodigital, "Rather than depending on government, industry must bring innovative ideas before VCs for the funding." According to Mr Rupinder Singh, CEO, Biohouse Solutions , "Government has to understand the needs of industry. 'Make in India' is not only about innovation but the things at ground level have to change for it to happen." Agreeing with him, Mr Dinesh Kumar, managing director, DesignInnova said that there is lack of translation of the ideas. "Budget lacked the actual thrust requires on the industry. The provisions for affordable infrastructure or transportation are missing," he added.Raising an important point, Mr N Venkat, CEO, Vyome Biosciences said, "To push the number of startups, the incentives in form of huge tax benefits are needed. We spend Rs 20 crore on doing science outside India just because taxes are unbearable here." Ms Guljit Chaudhary, CEO, BioInnovate "70 percent of the R&D in India is outsourced. Be it clinical trials or biosimilars, the focus has to be India centric. The requirement of DSIR certificate for funding has been a pre-requisite and I think we should change it. "Besides there is a need of social security for risk takers and some scheme must protect them," she added. Dr Shirshendu Mukherjee, Senior Strategic Advisor -India, Wellcome Trust, mentioned that industry has to do introspection as there is absence of enough novel ideas. "The funding should be available for high risk projects as well as capacity building funds should be earmarked separately. Adding further he said, "There is a need of three sixty degree approaches for funding and its managers must be capable of handling such money. BIRAC is a great experiment but needs to be replicated at a greater scale." In his frank opinion, Dr Anil Wali, MD, Foundation for Innovation and Technology (FITT) remarked, "If we are opening up innovation landscape, we have to provide the start ups a sustenance funding. There has to be a clear policy on biotech." He further added, "Now 1000 crore has been allocated for technology fund. But unfortunately most of the funds go for the academia centric research where conversion into commercial product is far lesser than industry. Shouldn't something be done about it? The participants also elaborately deliberated on the clinical trials issue. They felt that clinical research is moving to costly destinations like the US, Australia due to ease of business and urged government to extend funding to clinical research done at private facilities. Dr Jitendra Verma made an interesting comment: "The biotech entrepreneurship is a wonderful journey only if you know where the destination is." Missing in Budget:â€¢ No specific measures to stimulate growth of SMEsâ€¢ Make in India should stimulate development of ancillary units around manufacturing hubs. Not just a centralized manufacturing unit for exportsâ€¢ 25 percent preferential quota" for products made by SMEs in govt procurement required, particularly by premier institutions like AIIMS. Minimum turnover clause should be reduced drastically.â€¢ Remove preference for "academic tieups" in extending public research funds Suggestions: â€¢ 175 percent Weighted Tax Deduction for in house R&D should be extended to outsourced research servicesâ€¢ Recognition for Tax Deduction should be extended to clinical research done in outside hospital for all companies. Now only hospital gets this facilityâ€¢ Tax exemption for "reverse innovation" so that we have 1000s of new startups annually instead of 100s nowâ€¢ "Withholding Tax" on tech transfers should be abolished. Respective countries should take care of the taxation partâ€¢ Under "Make in India" program, steps to manufacture key analytical and measurement equipment in the country. ]]> <![CDATA[Prof. Arindam Ghosh awarded "Young Nanoscientist India Award 2015â€? ]]> https://biospectrumindia.com/news/95/3921/prof-arindam-ghosh-awarded-young-nanoscientist-india-award-2015-.html https://biospectrumindia.com/news/95/3921/prof-arindam-ghosh-awarded-young-nanoscientist-india-award-2015-.html Thu, 16 Apr 2015 18:31:47 +0530 Bharat Ratna Professor C.N.R Rao today presented the 'Oxford Instruments Young Nanoscientist India Award 2015' to Prof. Arindam Ghosh for his outstanding contribution to Nano Science in India at 'Nanotechnology Forum 2015'. The 'Nanotechnology Forum 2015' was hosted by the 'Nanotechnology Forum for Indian Scientists', also known as NT Forum. The NT Forum was formed in 2014 to encourage research in the field of Nanotechnology in India and acknowledge outstanding achievements in this field. NT Forum received 43 nominations of research carried out by eminent researchers from India. Technical talks were presented by, Sir Prof. Michael Pepper, University College London and Dr. Michael Cuthbert, Oxford Instruments UK. Committee member of the forum present on the occasion were Prof. A. K. Sood, Dept. of Physics, IISc and Prof. K. N. Ganesh, Director, IISER Pune. "The NT Forum and its committee were delighted at the high quality of nominations received, and the award winner was selected on merit for their outstanding contribution to Nano Science in India. Nanotechnology research in India deserves this sort of global recognition and to highlight good quality research carried out here." said Professor C.N.R Rao, Chairman of the NT Forum selection committee. Anurag Tandon, Managing Director, Oxford Instruments India Pvt. Ltd. said "Oxford Instruments congratulates Prof. Arindam Ghosh on the award for his research on nanoscale materials that has great importance in the areas of Nanoelectronics, especially in the developing sensors, energy storage devices and medical diagnostics. His dedication and devotion to the cause of nanotechnology have earned him this deserving recognition." As winner of 'Oxford Instruments Young Nanoscientist award 2015', Prof. Arindam Ghosh was awarded with a certificate, medal and cash prize of Rs 2,00,000 for his achievement. NT forum would also arrange for him to deliver talks in foreign universities as invited lecturer. ]]> <![CDATA[Global Youth Agri-Summit to be held in Oz]]> https://biospectrumindia.com/news/95/5856/global-youth-agri-summit-to-be-held-in-oz.html https://biospectrumindia.com/news/95/5856/global-youth-agri-summit-to-be-held-in-oz.html Thu, 16 Apr 2015 14:37:00 +0530 Future Farmers Network Australia and Bayer CropScience announced the upcoming 2nd Global Youth Ag-Summit, themed "Feeding a Hungry Planet", which will take place in Canberra, Australia, on August 24-28, 2015. India will send three delegates for the event, including: Ms Aatika Singh from New Delhi, Mr Raghav Raghunathan from Dewad in MP; and Mr Rohit Fenn from Kottayam, Kerala. A total of 1,932 essays from 87 countries were submitted. "We nearly received 2,000 essays from around the world which signals a strong interest in the issue of feeding a hungry planet. The quality of the essays was outstanding and the challenges and solutions identified highlight that opportunities like the Youth Ag-Summit provide a great platform to continue the discussions," said Ms Georgie Aley, chair, Future Farmers Network Australia. "We look forward to welcoming the delegates to Australia in August along with our partner Bayer CropScience in the delivery of the event." During the summit, the delegates will identify, connect and create ideas to progress agriculture around the world. "We believe there is a need for young leaders to be engaged in finding sustainable agricultural solutions to the growing global need for safe and nutritious food. The Youth Ag-Summit is an opportunity to broaden the perspectives from others around the world. It will also enable young leaders to further grow personally and develop their knowledge", stressed Mr Liam Condon, CEO Bayer CropScience. This collaborative approach aims to leave them with actionable ideas they take back to their home countries to embed into their personal operations and careers. Delegates from the following countries are expected to participate: Argentina, Australia, Belgium, Bolivia, Brazil, Canada, Chile, China, Estonia, France, Germany, Hungary, India, Indonesia, Italy, Japan, Kenya, Malaysia, Netherlands, New Zealand, Paraguay, Philippines, Poland, Singapore, South Africa, South Korea, Spain, Thailand, Turkey, United Kingdom, Uruguay, USA and Vietnam. ]]> <![CDATA[Strides receives ANDA approval from USFDA ]]> https://biospectrumindia.com/news/95/5729/strides-receives-anda-approval-from-usfda-.html https://biospectrumindia.com/news/95/5729/strides-receives-anda-approval-from-usfda-.html Thu, 16 Apr 2015 13:14:10 +0530 Strides Arcolab announced that it has received approval from the United States Food & Drug Administration (USFDA) for Polyethylene Glycol 3350, Sodium Chloride, Sodium Bicarbonate, and Potassium Chloride for Oral Solution, 420 grams/11.2 grams/5.72 grams/1.48 grams/4 liters. It is used for bowel cleansing prior to colonoscopy. Polyethylene glycol 3350 is an osmotic laxative, and along with the electrolytes, the combination is used in preparation for colonoscopy in adults and pediatric patients aged six months or greater. The product will be manufactured at the company's Oral dosage facility at Bangalore and marketed by Strides in the US market. ]]> <![CDATA[Sun Pharma to partner with Israel Institute of technology]]> https://biospectrumindia.com/news/95/6684/sun-pharma-to-partner-with-israel-institute-of-technology.html https://biospectrumindia.com/news/95/6684/sun-pharma-to-partner-with-israel-institute-of-technology.html Thu, 16 Apr 2015 11:19:33 +0530 Sun Pharmaceutical and the Technion - Israel institute of technology, have announced that their respective subsidiaries have entered into an exclusive worldwide research and license agreement. This agreement aims at the development of a joint project, based on new findings by Nobel Prize laureate professor Aaron Ciechanover, Dr Gila Maor and professor Ofer Binah, that can potentially lead to the development of novel anti-cancer drugs. The pre-clinical research was funded thus far by Dr Alfred Mann. "We are very excited about this new endeavor between Sun Pharma and the Technion. We are confident that this collaboration will help us move rapidly forward with our research. We explored several collaboration alternatives but Sun Pharma's market leadership and its long term commitment have made this collaboration a very high priority for us," said Professors Ciechanover and Binah. "The Technion is delighted to partner with Sun Pharma to advance this project through pre-clinical development process. This collaboration is an excellent example of interactions between academic discovery and pharmaceutical companies demonstrating the valuable contribution academic institutions can make in bringing new products to help patients worldwide. We sincerely believe this agreement represents the beginning of a long and fruitful relationship between the Technion and Sun Pharma," they added. "This collaboration is a part of the various initiatives that Sun Pharma is taking to enhance its specialty pipeline. Mutually beneficial partnerships with independent research institutes, especially world renowned institutes, such as the Technion, is our preferred route to bring to the market, innovative products for unmet medical needs," said Ms Kirti Ganorkar, senior vice-president, business development, Sun Pharma. ]]> <![CDATA[DMD treatment market to witness spectacular growth by 2019]]> https://biospectrumindia.com/features/95/5313/dmd-treatment-market-to-witness-spectacular-growth-by-2019.html https://biospectrumindia.com/features/95/5313/dmd-treatment-market-to-witness-spectacular-growth-by-2019.html Wed, 15 Apr 2015 14:26:14 +0530 The global treatment market for Duchenne Muscular Dystrophy (DMD) will expand in value at a staggering Compound Annual Growth Rate (CAGR) of 160.5 percent, from approximately $8.2 million in 2014 to $990 million by 2019, says research and consulting firm GlobalData. The company's latest report states that this growth will occur across six major markets: the US, France, Germany, Italy, Spain and the UK. Combined, the five European countries will contribute 55.2 percent to the total market value by 2019, while the US will account for 44.8 percent. According to Dr Nikhilesh Sanyal, GlobalData's analyst covering immunology, the primary driver behind this impressive expansion will be the market entry of PTC Therapeutics' Translarna, Sarepta Therapeutics' eteplirsen, and BioMarin/Prosensa's drisapersen. Dr Sanyal says: "These mutation-specific drugs are expected to have a high price point due to their novelty, efficacy and orphan drug status, and will contribute 85.6 percent to the DMD treatment arena by 2019. While Translarna is expected to be the top-selling DMD drug by 2019, exon-51-skipping therapies drisapersen and eteplirsen will also be a hotspot for growth, thanks to their rapid clinical development and significant demand. "Despite rapid developments in DMD therapeutics over the last five years, there remains a large unmet need among patients who are not amenable to these mutation-specific drugs, and who would benefit from effective disease-modifying therapies." However, the analyst adds that drug developers will need to overcome a number of challenges to take advantage of this major opportunity. He explains: "There is currently a lack of standardization for measuring clinical efficacy across all stages of DMD. While most studies use the change in the six-minute walk test as the primary clinical endpoint, this applies only to ambulant patients and therefore excludes non-ambulant individuals, as well as children under the age of five. "Furthermore, the high cost of novel disease-modifying drugs means that their reimbursement by local health authorities and insurance companies may be prevented following their entry into the arena," the analyst concludes. ]]> <![CDATA[AstraZeneca, PatientsLikeMe to partner for global research]]> https://biospectrumindia.com/news/95/5297/astrazeneca-patientslikeme-to-partner-for-global-research.html https://biospectrumindia.com/news/95/5297/astrazeneca-patientslikeme-to-partner-for-global-research.html Wed, 15 Apr 2015 11:14:34 +0530 In a major step forward to make patient-centric evidence a cornerstone of scientific discovery and development, AstraZeneca and PatientsLikeMe have signed a five-year agreement to provide access to PatientsLikeMe's global network in support of AstraZeneca's patient-driven research initiatives. AstraZeneca will use patient-reported data from PatientsLikeMe to shape the future of its medicine development and help improve outcomes across its main therapeutic areas, with an initial focus on respiratory disease, lupus, diabetes, and oncology. "Understanding what patients are experiencing every day and how they define the value of their treatments are fundamental to our ability to push the boundaries of science in developing the next-generation of medicines," said Mr Briggs Morrison, executive VP Global Medicines Development, AstraZeneca. He added, "Our partnership with PatientsLikeMe will help us harness the important perspectives of patients through their advanced technology and real-world, real-time evidence to support our research and development programmes." Mr Ed Godber, executive VP, Life Science Ventures, PatientsLikeMe said, "It's rare to find a partner so committed to listening to and integrating the patient voice into the heart of its scientific development and operations. We're excited to work together to transform the discovery and healthcare model and develop products and services tailored to what patients experience and truly need." ]]> <![CDATA[India, UK tie up for research to enhance agricultural nitrogen ]]> https://biospectrumindia.com/news/95/6111/india-uk-tie-up-for-research-to-enhance-agricultural-nitrogen-.html https://biospectrumindia.com/news/95/6111/india-uk-tie-up-for-research-to-enhance-agricultural-nitrogen-.html Tue, 14 Apr 2015 17:37:00 +0530 The first of of three research themes that have been identified for this call include the agronomic nitrogen use efficiency. This can be achieved by optimising farm practices and soil management to make more effective use of fertilisers and reduce losses of reactive nitrogen to the environment. Apart from that, the biological nitrogen use efficiency is another theme under the program. It will be focussed on improving the efficiency of nitrogen uptake or metabolism by plants. The third one is biological nitrogen fixation (BNF) for enhancing nitrogen-fixation in legumes or exploiting the potential of BNF in non-leguminous plants. As per the call from DBT, "Integrative, multidisciplinary and multi-scale approaches are encouraged, and there is particular scope for interaction between plant, agricultural and environmental scientists, and N2 use in the context of the global nitrogen cycle at the interface between the remits of DBT, BBSRC and NERC" This funding will be matched by the respective partner organizations. The full call text that will provide more information about the scientific scope, scale and instructions on how to construct and submit an application and will be announced by April 27, 2015. A Virtual Joint Center proposed for it as per notification, is essentially a large research grant that has additional flexibility to enable support to deliver the partnership and to enable existing resources to be allocated to the project. Activities that could be included within a Joint Center include joint research projects between researchers at the partner centers in agreed research areas; laboratory exchanges including short and longer term visits, exchange of graduate students, post-doctoral researchers or visiting fellows; sharing of key resources across the partner centres; supporting wider activities to strengthen links, for example holding symposia,workshops, seminars, meetings etc; equipment that will support the joint research. ]]> <![CDATA['We need right people at the right place': Industry]]> https://biospectrumindia.com/features/95/8300/we-need-right-people-at-the-right-place-industry.html https://biospectrumindia.com/features/95/8300/we-need-right-people-at-the-right-place-industry.html Tue, 14 Apr 2015 14:17:00 +0530 The event witnessed more than 35 participants from various top organizations and positions including CEOs, budding startup entrepreneurs, investors, policy makers and directors.In the back drop of the recent budget execution by Finance Minister Arun Jaitley in February 2015, the conclave opened wide doors for an engaging and stimulating discussion on the impact of the budget on the industry. Hosted by Mr Narayanan Suresh, group editor, BioSpectrum India & Asia, the forum offered a open setting for participants to express their view point, expectations, concerns and issues impacting the industry. Issues relating to tax payments and incentives, SME growth, innovation insurance, funding, government-industry collaboration, and clinical research dominated the discussion forum. Dr Mahadevappa, director, JSS Rural Development Foundation, opined, "It is a critical time that the government should come forward and exploit the potential. There are opportunities where without spending money farmers can derive benefits." Ecron Acunova's chairman, Mr D A Prasanna pointed that one of the major hurdles to 'Make in India' is the unsynchronized coordination between the Department of Pharmaceuticals, Department of Biotechnology and Department of Health. "Each department is trying to optimize their own objective instead of coming together and solving issues," he added. He suggested that a group or a forum between the secretaries of Pharmaceuticals, Biotechnology and Healthcare should ensure that issues are taken forward especially in clinical research. "Research has to be conducted in hospitals. Drug approvals take prolonged timeline and then there are issues of drug pricing. The faster we are able to bring together multiple departments, the more positive effects will be seen in bringing new drugs and innovations to the market," he explained. Mr Prasanna was seen to be optimistic about the speed of application processing by regulators. "What is very positive is that the speed of processing applications by the regulators has seen a major improvement, and the changes made by the new government is very encouraging. We welcome this move and will see to it that it continues," he shared. "In terms of schemes and opportunities, they are available in plenty," commented Mr Naveen Kulkarni, CEO and founder, Polyclone Bioservice. He felt that there is a missing link between different departments. "A group, division or a department, especially the state government, can take the lead and say that here is the scheme and this is how we will go about it. From the funding point of view, we have a lot. Execution and implementation takes time. The question is, having the right people at the right place. The government should now start thinking in terms of people," Mr Kulkarni held. Dr B V Ravi Kumar, founder and CMD, XCyton Diagnostics, said that one of the biggest hurdles in research is making it academic centric. "We need to have right people at the right place. At times there are schemes people don't understand or how it works. As a nation the general public is not for innovation. It is only willing to judge innovative companies versus non-innovative companies. I'm not even dreaming about innovation insurance. We should not be pushed through mechanisms that are not well understood," he expressed. Dr Ravi also said that the government doesn't want to know the industry's problems. "Budget only gives you a framework. What is hurting is that there was no mention about what is happening in the science and technology (S&T) area. Budget cuts on S&T will have a devastating effect on the industry. We should first innovate in India and then make it in India," he concluded. Mr R Raghu, VP, SchrÃ¶dinger, spoke in terms of investing in R&D in India. "In our country, there are many MNC pharma companies selling products and making millions. How much are they investing back in R&D in India? How many are setting up their R&D centres in our country? Sadly, they are vanishing. If this continues, in a few years from now India will not have any R&D happening," he lamented. "If biopharmaceutical MNC companies are selling products in India, and if their turnover is about $100 million, then they should spend at least $5 million towards R&D in India, which should be exempted from all taxes," he recommended. "Secondly, the government including DBT and CSIR are cutting finances in academics. On one hand innovation has to be developed, and on the other we have to spend money to innovate in R&D," said Mr Raghu. In China, R&D spend has increased and they are pumping more, he pointed. "In India, higher education and research has to be developed. When an academic institute is offered funding beyond Rs 5 crore, then it should be in collaboration with the industry, because there are big lacunae between them. It is crucial to bring in the industrial partners," he highlighted. Bangalore-based entrepreneur, Ms Monisha Hajra, founder, ScientiaBio, noted, "We generate more income from Singapore and Malaysia than from India. Most of our clients there hail from the government sector. All it takes is just one email to get the job done. It is easy for service companies to leverage on startup space, but what about diagnostics and project-based companies?" Many participants also emphasized on the funding woes faced while presenting the research proposal to committees. "The timing of the funding is significant. The bottleneck is that we don't have the right people in the right place. We need someone who understands commercialization and scaling up process. If we want innovation to happen, then the timing of the funding is very important. Also there is lack of clarity. Startups need a clarity on how regulations and funding work. This would help them get their funding at the right time. We need to address this if we are going to make the 'Make in India' campaign a stunning success," remarked Ms Ezhil Subbian, CTO, String Bio, another Bangalore-based startup. Mr Pradeep Karatgi, cofounder and director, IDRS Labs, said that getting the right license is an extremely time consuming process. "In Europe and the US, for example, there is always a streamlined process having specific timeline. In India marketing authorization takes 3 to 4 months, and at times even 30 months," he expressed. Mr B N Manohar, MD, Stempeutics, mentioned in terms of tax holidays and PM's support towards stemcells. "The government is willing to work with the industry to form a regulatory frame work. They are moving away from paper-based system to electronic system. In the last one year, I see a positive change in the speed with which things are processed. Whether it is about clinical trial approval or funding, if you have your proposal, they will act much faster. Another positive aspect is the supporting of innovation. Soon they are planning to adopt the Japanese framework. Over all, it is happening and there is a feel-good factor. The government should focus on tax reforms and nurture innovation. The 100 percent FDI for medical devices is commendable," he explained. Mr Manjunath Devaramani, R&D head, Denovo Biolabs, a new startup at IBAB, commented on product pricing and competency. "We have our own challenges. We develop our products and compete with major players inside and outside India. To be competent we need to be competent in quality at lower prices. But we have to pay sales and services taxes and corporate taxes. How do we keep the costs lower when taxes are so high? There must be a system, at least for startups, offering benefits like tax slabs," he said. Mr Bhavik Kumar, cofounder of the four-month old Bangalore startup, Medibox, supported the PM Modi's Swach Bharat, Make in India and Digital India campaigns. "Investments are going to be huge in digital healthcare in accordance with our PM's campaign, and it can run well on it," he revealed. Dr Arumugam Muruganandam, founder, MD & CSO, Affigenix, suggested that the government should operate like VCs when it comes to funding. "The VCs have consulting in every field. The government, on similar lines, has consulted experts in the industry in certain cases while dealing with bigger grants. It has to continue this by operating like VCs, where they approach experts, evaluate and manage the money," he advised. Dr Jagadish Mittur, head, Biotechnology Facilitation Cell (BTFS) at KBITS, emphasized on industry experts working alongside with the government for the betterment of the existing system. "We got to be practical. We have to work on the existing system because it seems to be sloppy. How many people are willing to come and work in the government sector? Scientific professionals can become 'Scientocrats' and academicians can volunteer to work and improve the system. We should not underestimate the competence of people who hail from academics. We must work on aligning the State's biotechnology framework with the national framework," he impressed. He feels that the government is interested in creating more and more innovation clusters to create an environment that is entrepreneurial. "The future is going to be bright for Karnataka. Now, what is missing is the upliftment of agriculture sector. There are many drought stricken districts in Karnataka. And water availability seems to be the biggest problem. The Central government should spend its budget to address the water scarcity. Unless this is addressed, it is going to be very difficult to see any progress in the agri sector, and consequently this is going to affect our country drastically," Dr Mittur added. "The sentiments of the industry and the government needs to be synchronized. The budget allocations aren't very clear," stressed Mr Veerbhadra Yadwad, product manager, environmental and analytical group, Yokogawa India. Dr Binay Panda, chief officer and head, Ganit Labs, voiced that people on research proposal judging committee do not understand commercialization. "We do not even have the right or enough people who can judge a research proposal. Ninety-nine percent of the people who sit on judging committees are purely from academics and do not have any idea or experience about commercialization aspects," he added. "The amount of money we have should be distributed efficiently by improving the existing system. We should work together in helping the government improve the system and getting the money in the hands of people, rather than complain about what the government is not doing," Dr Panda mentioned. Mr Suresh Ramu, cofounder & CEO, Cytespace, commented on the origin of innovation and nurturing it to the fullest. "There is enough talent and risk-taking appetite. One cannot support large organizations and expect innovation. Innovations can also come from smaller companies. They need to be developed and promoted. In a global setting, we cannot bring in regulations and say that foreign drug molecules cannot be authorized to carry out research. We cannot blanket research. On the healthcare side, spending 2 percent of GDP is fantastic, but it is not enough. The government needs to create a framework. Healthcare incentives and import duties needs to be taken care. Increasing import duties will enable local manufacturers to compete," he held. ]]> <![CDATA[Resist putting pressure for aggressive IP policies: MSF]]> https://biospectrumindia.com/features/95/7668/resist-putting-pressure-for-aggressive-ip-policies-msf.html https://biospectrumindia.com/features/95/7668/resist-putting-pressure-for-aggressive-ip-policies-msf.html Tue, 14 Apr 2015 13:24:18 +0530 On the occasion of the visit of Indian Prime Minister Narendra Modi to Germany, MÃ©decins Sans FrontiÃ¨res (MSF) calls on German Chancellor Angela Merkel to refrain from pushing for harmful IP provisions in the EU-India Free Trade Agreement (FTA) which is currently under negotiation. The EU-India FTA has been in negotiations since 2007. From the outset, the European Commission has pushed to include provisions that would undermine India's ability to produce affordable medicines on which millions of people in developing countries rely. It is expected that Modi and Merkel are going to talk about the reinstatement of negotiations for the controversial EU India free trade agreement. India's leadership in producing affordable medicines is due to its patent law which applies internationally recognized legal safeguards for public health which allows generic competition to flourish, bringing down the prices of medicines for HIV, TB, and hepatitis C by over 90 percent. Mr Philipp Frisch, coordinator, Access Campaign Germany states: "For years, the EU - blindly lobbying for their pharmaceutical industry - has pressured India to introduce harmful policies in a bid to stamp out competition from Indian generics. We urge Chancellor Angela Merkel to resist putting pressure for aggressive IP policies that will severely restrict people's access to these life-saving medicines in her talks with Prime Minister Modi." In light of the German G7 presidency and the G7's focus on global health, it would be a fatal signal to restrict Indian generics production by demanding IP provisions going well beyond current trade rules. These provisions would impact on access to life-saving drugs from India, having a dramatic effect on MSF's work and putting millions of lives in the balance. "The 'Make in India' campaign is a push by the Indian government to encourage India as a manufacturing hub. However, increased levels of intellectual property in areas such as pharmaceuticals could potentially come at the expense of undermining public health provisions and local production which have made India the 'pharmacy to the developing world' supplying affordable generic versions of life-saving medicines," says Ms Leena Menghaney, head, South-Asia, MSF Access Campaign. ]]> <![CDATA[Data analytics in health: Deakin University, Max Health partner to utilize patient data]]> https://biospectrumindia.com/news/95/4059/data-analytics-in-health-deakin-university-max-health-partner-to-utilize-patient-data.html https://biospectrumindia.com/news/95/4059/data-analytics-in-health-deakin-university-max-health-partner-to-utilize-patient-data.html Tue, 14 Apr 2015 12:33:20 +0530 In a country like India where priorities are more often anything but health, the loss of data on patients and their disease history, surely comes off as a no big deal. But only few know that the use of such data can open new avenues for preventive medicine in future. So are we doing anything about that? At least on private front, the movement has started. Deakin University, Australia and Max Healthcare in a first of its kind venture, are bringing 'big data' to work for medicine with its huge records of patient history - with data on admissions, diagnosis and outcomes, spanning a huge inventory of images. Besides that the computerized records and registries and the consequent untapped potential to identify critical safety issues, as well as service and clinical efficiencies. Dr Sandeep Budhiraja, clinical director and director, Institute of Internal Medicine, told BioSpectrum, "Given the kind of huge gaps in patient data handling and effective usage, this project is definitely a right step forward. This association will be a landmark project and take healthcare management to a different level. We look forward to working with Deakin in order to advance research on data analytics for health data." As part of the agreement, Max Healthcare and Deakin University will jointly address this pressing need by leveraging state-of-art and verified techniques in data analytics to support clinical decisions. The outcomes are critically important from economic, patient safety and systems perspectives. The immediate project will focus on heart disease, specifically on patients with index admission [symptoms] of Acute Myocardial Infarction (AMI) or Stroke. The project is being run on experimental basis for next six months and after review on its implementation, will be taken forward on a bigger scale. According to, Prof Svetha Venkatesh, director, Pattern Recognition and Data Analytics, Deakin University said, "The primary objective of the project will be to search through the existing data sets for hidden patterns of both the predictable and preventable events in managing the healthcare of individuals. This will be done by building sophisticated predictive models, utilising machine learning techniques derived from anonymised hospital patient records from diverse hospital data sources. This paradigm is novel, since it is capable of both hypothesis generation and testing, whilst being agnostic and unbiased to prior assumptions." A joint team will analyse the data, extract relevant features and build a validated machine learning model for specific prediction task. The resultant model will be jointly held and shared by the teams at Deakin and Max healthcare as a prototype program. Once successful, the model would be subsequently piloted at Max Healthcare on prospective cases over a period of one year and the predictive accuracy would be calculated and shared with Deakin team. ]]> <![CDATA[Roche acquires CAPP Medical ]]> https://biospectrumindia.com/news/95/6141/roche-acquires-capp-medical-.html https://biospectrumindia.com/news/95/6141/roche-acquires-capp-medical-.html Tue, 14 Apr 2015 11:35:36 +0530 Roche has announced that it has acquired CAPP Medical to advance the development of technology for cancer screening and monitoring through the detection of circulating tumor DNA (ctDNA) in blood. CAPP Medical is a genomics research company founded by Stanford University oncologists and industry veterans. CAPP Medical's novel technology is designed to isolate and quantify small amounts of ctDNA through a simple blood draw, which has the potential to be used for cancer therapy selection and monitoring tumor response and resistance to therapy. "Roche believes focused and high quality next generation sequencing (NGS) assays using simple blood draws have the potential to significantly advance the time of cancer diagnosis and change routine cancer diagnostic monitoring and may be highly cost effective compared to today's current standard of using PET and CT imaging to monitor tumor progression," said Mr Roland Diggelmann, COO, Roche Diagnostics. He added, "CAPP Medical's technology for detecting the circulating cancer DNA from blood has the potential to further strengthen Roche's diagnostic offerings for patients and will provide valuable clinical trial support for Pharma oncology pipelines." "This acquisition highlights Roche's commitment to advancing cancer testing. We strongly believe Roche is the best suited company to advance this technology and bring it to its full potential," said Mr Ashok Krishnamurthi, CEO of CAPP Medical. ]]> <![CDATA[New Drugs for Malaria, Diabetes, Osteoporosis soon]]> https://biospectrumindia.com/news/95/5004/new-drugs-for-malaria-diabetes-osteoporosis-soon.html https://biospectrumindia.com/news/95/5004/new-drugs-for-malaria-diabetes-osteoporosis-soon.html Mon, 13 Apr 2015 13:16:03 +0530 The Indian pharmaceutical sector would soon be showcasing candidate drugs for malaria, osteoporosis and diabetes said Dr Harsh Vardhan, Union Minister for Science and Technology and Earth Sciences. He further informed that the candidate drugs are currently undergoing clinical trials. "I am confident that the drug laboratories under CSIR are capable of backing up the Swasth Bharat Mission. Our scientists are focusing on both infectious and life-style diseases. We are developing next-generation drugs, biologics, biosimilars, gene therapeutics, stem cell therapeutics, personalised medicine and multifunctional nanomedicine," said Dr Vardhan, in a statement. He added, "I am certain that the country has the potential of becoming a global pharmaceutical powerhouse and am in the process of putting some key enablers in place. These include giving the right incentives for R&D, forging alliances with the private sector and keeping an open mind on suggestions for fiscal relief to the private sector so that its role in R&D is enhanced." The minister has also announced the formation of a National Centre for Laboratory Animals in the CDRI new campus conforming to national and international guidelines. The new institution would serve as a referral centre for lab animal breeding and experimentation for new drug development. The ministry is also considering setting up Government Laboratory Practices (GLP) certified labs in CDRI for complete range of Investigational New Drug (IND) studies, informed Dr Vardhan. ]]> <![CDATA[TFS, NUS to fund three new projects]]> https://biospectrumindia.com/news/95/4993/tfs-nus-to-fund-three-new-projects.html https://biospectrumindia.com/news/95/4993/tfs-nus-to-fund-three-new-projects.html Mon, 13 Apr 2015 13:14:42 +0530 TFS and the NUS announced three research projects, which are supported under their strategic alliance. Each project could receive a grant of up to $300,000 (Singapore Dollars) per year. The five-year strategic alliance formed by the two parties in April 2014 has committed to sponsor both multi-year and short-term research grants to accelerate life sciences, as well as to support activities that encourage knowledge exchange among NUS researchers and TFS's scientists. This alliance is facilitated by the NUS Industry Liaison Office, which is part of NUS Enterprise. ".....NUS will continue to forge strong collaborations with industry, to translate our research into impactful innovations for the benefit of society," said Ms Irene Cheong, director, NUS Industry Liaison Office. The call for proposals for the multi-year grants attracted over 50 applications from various labs and investigators across NUS. The selected research projects were chosen based on the application of the research to the request for proposal topics generated from TFS and NUS, including potential for future commercial viability. These projects cover three areas of research: synthetic biology, analytical applications and stem cell biology. "...Our alliance with NUS will also help to accelerate innovation from Singapore, which will benefit the people of the Asia Pacific and the world," said Dr Alan Sachs, CSO, Life Sciences Solutions, Thermo Fisher Scientific Moving forward, the Thermo Fisher Scientific-NUS strategic alliance is now in the process of selecting projects for the Discovery Innovation Grants (DIGs). The DIGs will support investigation of new areas or new applications of existing technologies that come under the spotlight such as: Next Generation Sequencing, Genetic Analysis, Molecular Diagnostics, Food Safety and Animal Health, Life Sciences and Chromatography and Mass Spectrometry, Rare Cells & Single Cells and Synthetic Biology. The grant period will be for one-year and up to $100,000 (Singapore Dollars) for each project. The projects will be selected in May. ]]> <![CDATA[Novo Nordisk opens a new insulin production facility]]> https://biospectrumindia.com/news/95/4989/novo-nordisk-opens-a-new-insulin-production-facility.html https://biospectrumindia.com/news/95/4989/novo-nordisk-opens-a-new-insulin-production-facility.html Mon, 13 Apr 2015 12:43:07 +0530 Novo Nordisk opens a new manufacturing facility in Russia for formulation and filling of modern insulin for the treatment of diabetes. The production will cover both Penfill cartridges and FlexPen prefilled insulin injection pens for the Russian market. The new facility will be operating in accordance with current Good Manufacturing Practices (GMP), and is located in Technopark Grabtsevo in the Kaluga region of Russia. "The manufacturing facility in Kaluga is a sign of our long-term commitment to people with diabetes in Russia, where close to 10 million people have the disease according to local studies. With our investment in local manufacturing, we ensure availability of high-quality modern insulins to the people with diabetes in Russia who rely on our products every day," said Mr Lars Rebien SÃ¸rensen, CEO of Novo Nordisk. Novo Nordisk also has production sites in Denmark, Brazil, China, France and the US. ]]> <![CDATA[Diverse drug pipeline could transform liver cancer treatment]]> https://biospectrumindia.com/features/95/7139/diverse-drug-pipeline-could-transform-liver-cancer-treatment.html https://biospectrumindia.com/features/95/7139/diverse-drug-pipeline-could-transform-liver-cancer-treatment.html Mon, 13 Apr 2015 12:41:36 +0530 The company's latest report states that the liver cancer pipeline contains a large amount of first-in-class innovation, contrasting heavily to the market landscape, which has shown little in the way of therapeutic innovation in recent years, with the exception of Nexavar (sorafenib). While liver cancer is the sixth most common cancer worldwide, its poor prognosis makes it the second leading cause of cancer death. Rising prevalence in developed economies and the success of targeted oncology therapies are factors driving interest in drug development. Mr Joshua Libberton, analyst, GBI Research, says: "The liver cancer treatment market is highly segmented in terms of its needs, as early-stage patients have access to curative therapies, such as surgical resection, and have a relatively strong outlook. "However, for patients diagnosed in later stages, who represent the majority of the patient population, treatment is limited to chemotherapy, which does not provide an appreciable benefit to Overall Survival (OS), and the targeted therapy Nexavar, which does offer a limited OS benefit." Compared to the 62 currently marketed therapies, there are 218 products in active development in the liver cancer pipeline, 76 of which are acting on 61 first-in-class targets. This represents a remarkable 49 percent of the pipeline with a disclosed molecular target, somewhat higher than the 43 percent first-in-class average across the entire oncology pipeline, according to GBI Research. Mr Libberton continues: "The early stages of clinical development are host to the majority of first-in-class products, although there is a significant degree of first-in-class development in the later stages, particularly in the signal transduction target family. "With each major target family showing at least some degree of first-in-class development, the future liver cancer treatment market has a high likelihood of gaining an array of new therapy types and targets, broadening the scope of potential benefits for patients. This trend will lead to the approval of more targeted therapies over the coming decade." ]]> <![CDATA[Frontier Lifeline's cardiac stem cell research approved]]> https://biospectrumindia.com/news/95/4854/frontier-lifelines-cardiac-stem-cell-research-approved.html https://biospectrumindia.com/news/95/4854/frontier-lifelines-cardiac-stem-cell-research-approved.html Mon, 13 Apr 2015 12:04:46 +0530 The Institutional Committee for Stem Cell Research (IC-SCR) of Frontier Lifeline Hospital and Dr K M Cherian's Heart Foundation has been registered and certified by The National Apex Committee for Stem Cell Research and Therapy (NAC- SCRT) to oversee the activities in the field of cardiac stem cell research for a period of three years. Chennai-based Frontier Lifeline Hospital (FLL) has been already involved in cardiac stem cell therapy post the approval by Clinical Trial registry of India, Indian Council of Medical Research (ICMR) in 2010. The center performed 100 cases proving the safety and efficacy of cardiac stem cells. And now, NAC-SCRT, the apex body constituted by the Department of Health Research, Ministry of Health and Family Welfare, Govt. of India, has registered the Institutional Committee for Stem cell research of the hospital and its research centre - Frontier Mediville for performing Cardiac stem cell therapy treatments. The hospital also revealed that the committee has been certified based on its successful adherence to ethical guidelines and stem cell research done by the department of tissue engineering and regeneration medicine at FLL and Mediville. ]]> <![CDATA[IAVI scales up efforts to cross new frontiers]]> https://biospectrumindia.com/features/95/6089/iavi-scales-up-efforts-to-cross-new-frontiers.html https://biospectrumindia.com/features/95/6089/iavi-scales-up-efforts-to-cross-new-frontiers.html Sat, 11 Apr 2015 08:26:00 +0530 Each year, the persistent global diseases such as AIDS, tuberculosis and malaria, together kill more than 3.5 million people and infect millions more, despite impressive advances in treatment and prevention. Experts say that the successful vaccine development strategies developed in past might not work against a number of today's complex parasites, bacteria, viruses and cancers. In the background of growing concerns over lack of solutions, the 35 experts from industry, academia, government and nongovernmental organizations had met on February 5-6, 2014 in California, and "concluded that the concept for a Human Vaccines Project was meritorious, timely and potentially transformative," the report stated. The group identified three major common challenges in vaccine research and development: an insufficient understanding of how to generate specific, potent, broad and durable immune responses in humans; an insufficient understanding of precise antigens required to produce desired protective immunity, and a need for a deeper appreciation of how best to optimize vaccine efficacy in newborns, the elderly and populations in the developing world. They recommended that the Human Vaccines Project focus on mapping the human immune system into a "human immunome" to facilitate vaccine discovery, and on a comprehensive series of systematic human immunology-based clinical research studies with experimental vaccines aimed at solving the identified scientific challenges and overcoming the limited predictive powers of animal models. "Creating an enabling environment for and implementing such trials, and ensuring close engagement with the vaccine industry and public sector research agencies, would be keys to the project's success," said report co-author Ian D Gust, professorial fellow, Department of Microbiology and Immunology, University of Melbourne, who chaired the meeting. The February meeting was the first of three workshops to catalyze the project, with an initial focus on identifying key objectives to inform the project's scientific plan. The second workshop, held in July, focussed on organizational, management and financial questions to inform a business plan. The third workshop to be held soon will bring together key stakeholders and potential donors to review the scientific and business plans and prepare for a projected launch in 2015. The three initial workshops are funded by a grant to IAVI from the Robert Wood Johnson Foundation. "There was a very strong consensus that we now have the tools to radically change the paradigm for vaccine development and usher in a new era in disease prevention," said workshop participant Dr MK Bhan, former secretary of the Department of Biotechnology, ministry of science and technology, government of India. The business leaders from public and private sectors in July 2014, reviewed the Project's mission and goals, and recommended the Project be structured as a global, nonprofit research and development (R&D) consortium closely engaged with industrial partners, and affiliated with one or more academic centers conducting vaccine R&D (Expert Review of Vaccines, in press). The Project is currently in the process of establishing the principal hubs of such a consortium, including exploration of centers in the United States, Europe and Asia, to which leadership of the Project will then transition from IAVI, its initial catalyst. "The Human Vaccines Project is driven by the rapid pace of technological advances in genomics, bioinformatics and structural and systems biology, and likely would not have been possible even five years ago. It is a tremendously exciting time in vaccinology as we move toward preventing very challenging global killers such as AIDS, TB, malaria, Ebola, and cancers. Science and innovation will get us the vaccines we need," said Mr Stanley Plotkin, emeritus professor of the University of Pennsylvania and chairman of the Human Vaccines Project Steering Committee. Industry's support for sustained efforts A grant of $350,000 from GSK has pumped new muscles to the efforts of IAVI to support implementation of the Human Vaccines Project, a new public-private partnership. Through the programme, it seeks to transform global disease prevention by collaboratively addressing some of the key scientific challenges in vaccine development across diseases. The GSK grant will help to establish the Project's global consortium and plan its research program. The funding builds on a grant last year to IAVI by the Robert Wood Johnson Foundation for a series of workshops to explore how to accelerate development of vaccines through such project, by tackling the major scientific challenges impeding vaccine R&D through greater collaboration, increased knowledge sharing, and innovation. The first workshop, held in February 2014, focused on the scientific challenges to vaccine development, at which leading vaccine experts endorsed the Project's objectives and helped to frame its scientific plan. Dr Wayne C Koff, chief scientific officer, IAVI and founding member of the Human Vaccines Project Board, announced the GSK grant during his recent visit to India. "A Human Vaccines Project focused on solving the major scientific problems impeding vaccine development could be transformative for efforts to help prevent these devastating infectious diseases as well as certain cancers. Industry involvement will be key to the success of the project, and we are excited that GSK has become the first corporate partner. Their support will help to engage other pharmaceutical partners to join this important new initiative," mentioned Dr Koff. "For all that we have achieved with vaccines, there are still far too many diseases that we can't prevent and which have a devastating impact, particularly in the developing world," said Mr Emmanuel Hanon, senior vice president, Vaccines Research and Development, GSK. "The more we can do both individually and collectively to overcome the current scientific challenges the better. We are very pleased to support the Human Vaccines Project and we encourage others to join us in this potentially ground-breaking initiative." ]]> <![CDATA[Cipla to buy Brazilian Pharma firm]]> https://biospectrumindia.com/news/95/4302/cipla-to-buy-brazilian-pharma-firm.html https://biospectrumindia.com/news/95/4302/cipla-to-buy-brazilian-pharma-firm.html Fri, 10 Apr 2015 15:10:59 +0530 Cipla, has said its UK subsidiary Cipla (EU) will acquire Brazilian firm Duomed Produtos Farmaceuticos for about Rs 2.6 crore. "Cipla (EU), a wholly-owned subsidiary of Cipla, has entered into a definitive agreement for acquisition of 100 percent stake in Duomed Produtos Farmaceuticos, for a cash consideration of Brazilian Real (R$) 1,293,600 (about Rs 2.6 crore)," Cipla said in a filing to the Bombay Stock Exchange (BSE). "The deal has the approval of Brazilian health authority (ANVISA) and other regulatory authorities to import and distribute pharmaceutical products in Brazil," the filing said. The transaction is expected to be completed by the end of May 2015, subject to certain conditions. The acquisition is part of Cipla's front-end strategy and will expedite its product registrations in Brazil. ]]> <![CDATA[Top mid-cap Bt companies increased revenues to $26.5 bn in 2014]]> https://biospectrumindia.com/features/95/4325/top-mid-cap-bt-companies-increased-revenues-to-26-5-bn-in-2014.html https://biospectrumindia.com/features/95/4325/top-mid-cap-bt-companies-increased-revenues-to-26-5-bn-in-2014.html Fri, 10 Apr 2015 15:10:14 +0530 The combined total revenues for the peer group of 35 mid-cap biotech companies increased from $24.8 billion in 2013 to $26.5 billion in 2014, representing a compound annual growth rate (CAGR) of 21.9 percent, according to research and consulting firm GlobalData. The company's latest report states that this growth was marginally slower than during the previous five years, as total revenues for this peer group expanded at a CAGR of 25.2 percent between 2009 and 2013. Mr Adam Dion, GlobalData's healthcare industry analyst, says the rise in biotech peer group total revenue over the past year was driven by Regeneron and Alexion, both of which posted sales of more than $2 billion in 2014. He explains: "Regeneron's sales grew by 34 percent in 2014, as the company continued its commercialization of Eylea (afilibercept) to markets outside the US, including for the treatment of macular edema secondary to central retinal vein occlusion in both the EU and Japan. "Alexion saw sales from its orphan drug Soliris (eculizumab) increase from $1.6 billion in 2013 to $2.2 billion in 2014. Alexion reported a higher volume of unit shipments and better-than-expected demand for Soliris across all geographic regions, especially in the EU, thanks to a reimbursement agreement with the French government." The analyst adds that Pharmacyclics, which was acquired by pharmaceutical giant AbbVie last month, was the peer group revenue growth leader in 2014. Its sales shot up by 180 percent in 2014 to $729 million, representing an absolute dollar increase of nearly $470 million. GlobalData attributes this surge to Pharmacyclics recognizing nearly $493 million in new product revenue from sales of Imbruvica (ibrutinib), the company's first-in-class BTK inhibitor approved to treat blood cancer patients with chronic lymphocytic leukemia and mantle cell lymphoma. By contrast, some companies experienced sales decreases, most notably Vertex, which saw revenues decline by 52.1 percent, from $1.2 billion in 2013 to $580.4 million in 2014. Mr Dion comments, "This drop was largely attributable to sliding sales of Incivek (telaprevir), Vertex's hepatitis C virus protease inhibitor, which fell by $442.3 million compared with 2013, primarily as a result of increased competition from Gilead's Sovaldi (sofosbuvir) and Janssen's Olysio (simeprevir)." ]]> <![CDATA[EU approval for Roche's cervical cancer drug]]> https://biospectrumindia.com/news/95/6347/eu-approval-for-roches-cervical-cancer-drug.html https://biospectrumindia.com/news/95/6347/eu-approval-for-roches-cervical-cancer-drug.html Fri, 10 Apr 2015 12:19:43 +0530 Roche has announced that the European Commission (EU) has approved Avastin (bevacizumab) in combination with standard chemotherapy (paclitaxel and cisplatin or, alternatively, paclitaxel and topotecan in patients who cannot receive platinum therapy) for the treatment of adult patients with persistent, recurrent or metastatic carcinoma of the cervix. Avastin's EU approval in persistent, recurrent or metastatic carcinoma of the cervix is an important development in a disease area where, until now, treatment options were limited to chemotherapy. "We are pleased that women in Europe now have a much needed new treatment option that is proven to help them live longer lives compared to chemotherapy alone," said Dr Sandra Horning, chief medical officer and head of global product development. "Currently, fewer than one in six women with this disease are alive five years after diagnosis. Avastin's approval is a welcome advance for women with persistent, recurrent or metastatic carcinoma of the cervix". The EU approval was based on the significant survival benefit in the pivotal GOG-0240 study, which showed that women who received Avastin plus chemotherapy had a statistically significant 26 percent reduction in the risk of death, representing a median improvement in survival of nearly four months, compared to women who received chemotherapy alone (median overall survival: 16.8 months vs. 12.9 months; Hazard Ratio (HR)=0.74, p=0.0132). Also based on the GOG-0240 data, Avastin in combination with paclitaxel and cisplatin or paclitaxel and topotecan chemotherapy was approved in the US in August 2014, in Switzerland in December 2014, and in six other countries worldwide, for the treatment of women with persistent, recurrent or metastatic carcinoma of the cervix. ]]> <![CDATA[101 million Indians to be diabetic by 2030]]> https://biospectrumindia.com/news/95/5691/101-million-indians-to-be-diabetic-by-2030.html https://biospectrumindia.com/news/95/5691/101-million-indians-to-be-diabetic-by-2030.html Fri, 10 Apr 2015 10:52:47 +0530 "It is estimated that 61.3 million people aged between 20 and 79 years live with diabetes in India and this number is expected to increase to 101.2 million by 2030," said Dr. K Rosaiah, Governor of Tamil Nadu, at the '6th World Congress of Diabetes India' in Chennai. The Governor formally inaugurated the four-day conference on diabetes in the presence of Dr. G Vijayakumar, Organizing Secretary, Diabetes India 2015, Dr. Shaukat Sadikot, President, Diabetes India 2015, Dr. Banshi Saboo, Congress Chairman, Diabetes India 2015, Dr. Krishna Seshadri, Scientific Chairman, Diabetes India 2015, Dr. S R Aravind, Hon. Secretary, Diabetes India 2015, renowned medical practitioners from across the globe and other senior government officials from the centre and state. The 6th World Congress of Diabetes India in Chennai from April 9th to 12th will witness the participation of more than 200 national and 50 international speakers in the field of diabetes, and more than 3000 delegates from India and various other countries. The conference features various programs such as CME, orations, scientific sessions, debates, symposium, workshops, clinical case discussions and networking opportunities with experts on diabetes. At the inauguration Dr. G Vijayakumar, Organizing Secretary, Diabetes Medicare Centre, Chennai, said, "There are more than 63 million diabetics in our country to treat and we do not have the sufficient number of specialists and doctors. Around 95% of patients have been treated by family physicians and primary care doctors. This conference has been organized to educate and train those practicing doctors so that they are well equipped to deliver appropriate healthcare to diabetic patients in India." Dr. Shaukhat Sadikot, President, Diabetes India 2015, expressed that the main aim of this conference is to put forward the basic guidelines in the management of diabetes. He also expressed that this analytical-scientific conference will not only benefit the doctors and clinicians but also influence and equip the young researchers about the medical advancement in the field of diabetes. Dr Sadikot statistically pointed out that globally diabetes caused 5.1 million deaths in 2013. Every six seconds a person dies from diabetes and diabetes-related complications of the eye and nervous system is an emerging global economic burden. Speaking at the conference Dr. Banshi Saboo, Congress Chairman, Diabetes India 2015, commented, "India has a vast population of 70 million subjects with diabetes, which is gradually heading to a tsunami of costly and dreaded complications. To address the issue, Diabetes India has joined hands with a group of diabetologists, endocrinologists and other physicians interested in diabetes along with renowned medical practitioners from across the globe to organize this scientific conference with the aim of providing affordable, accessible and most importantly accountable treatment to diabetic patients. This conference is an ideal platform for young researchers and experienced clinicians to present their research and clinical papers." Diabetes India is a registered trust that works for Diabetes Awareness Management activities in India. It has a multitude of doctors as members and organizes its annual conference once in every two years, to empower the knowledge of practicing physicians and updating them with the latest development in the management of diabetes. The conference provides a platform for young researchers and scientists to present their original research work during the conference. ]]> <![CDATA[National Health Policy 2015: What is the govt proposing?]]> https://biospectrumindia.com/features/95/5849/national-health-policy-2015-what-is-the-govt-proposing.html https://biospectrumindia.com/features/95/5849/national-health-policy-2015-what-is-the-govt-proposing.html Fri, 10 Apr 2015 09:35:00 +0530 CIIThe CII proposes a "composite" and "hybrid" model based on following tenets for implementing the Universal Health Coverage (UHC) in India in faster and efficient manner with utmost economy.â€¢ The model aims at developing a basic and essential UHC package, consisting of primary, secondary and tertiary care, which would be affordable and accessible to every citizen, inclusivity all components of care - "Primary", "promotive" and "preventive".â€¢ The model proposes to strengthen primary healthcare and other determinants of health like safe drinking water, sanitation, and nutrition by making it the core focus of the Government and public health systemâ€¢ It proposes utilization of health insurance for providing secondary care package of Rs 60,000 topped by tertiary care package of Rs 2 lacs to all CII also proposes that at present the Government of India and State Governments are running disparate schemes for healthcare e.g. RSBY, Arogyashri, Tamil Nadu Health scheme, CGHS, ESIS, and programs like NRHM, all running parallel to each other, often duplicating efforts and scarce resources. It is necessary that all schemes are brought under one umbrella for efficient pooling and management. The proposed model fits quite well with the Government of India's intent to increase health spend from 1.1 percent to 3 percent over a period of 10 years. VHAIMeanwhile, Voluntary Health Association of India (VHAI) called the draft policy a vision document. "There is a basic difference between a vision document and a national policy. The present draft reads more like a vision document which is aspirational. A national policy should be result focused and should have a specific time frame with clear articulation on resource needs. It should essentially concentrate on what Government intends to do, both in its regulatory and developmental roles. The document can be short and crisply written, and lot of the verbosity and repetition in the draft can be pruned.""There should be a strong monitoring system to review and monitor progress on achievement of the goals set in the NHP. This should be an integral part of the Policy. This should not be restricted by budgetary cuts and constraints, which are implementation problems," it added.VHAI stated that the goal of National Health Policy should focus on, saying, "Health is not about drug, disease management and doctor but about healthcare with appropriate focus on prevention and wellness." On the goals, principles and objectives in the draft, VHAI said, "among the 'key principles' listed, preventive/promotive or public health should be added. It is a serious omission. There should be stronger emphasis on equity as a basic principle. The global principle of 'no one should be left behind' as a key component of the post 2015 development agenda must be echoed in the national policy framework. We should also add principles of comprehensive healthcare and justice. The principle of affordability should be removed as it is contrary to the principles of Equity and Universality." VHAI in its observation on draft policy said that the key areas of concern not addressed in the draft policy include:â€¢Specific Areas that need amplification- Tuberculosis and Diabetes are two areas which need stronger write ups. Malnutrition and combating Anaemia in women and children again need more discussion.â€¢Community Monitoring of Government programs - The policy of the country is to encourage more Community Monitoring of government programs. This does not come out strongly enough in the Policy Document.â€¢Youth Health: There is no discussion of Youth health in Draft NHP-2015. The picture of healthy adolescents and youth of our country has been rapidly changing in recent years due to sedentary lifestyles, diet changes, and attitudes of youth towards health. Adolescents face a myriad of health challenges including sexual and reproductive health, drug/substance abuse, and exercise but most of the problems faced by adolescents and youth have common antecedents and are preventable. There is a need for special focus on the much neglected/ ignored adolescent and youth group in this policy document. These policies should be youth empowerment programs which are need-based and gender sensitive. They must be integrative and holistic in their approach rather than having, for example, separate programs for sexual and reproductive health, drug/substance abuse, diet and exercise. â€¢Elderly care, emergency care, disaster preparedness, and mental health are mentioned without discussing the integration of the already existing policies on these issues.â€¢No mention of inter-ministerial integration of schemes and programs of matter related to health in the implementation process.â€¢Dental Health is included only under NCDs, and no mention of eye care at all. These should be covered separately.AHPI and KPMG"In time to come, we hope to see a happy and healthy India under the National Health Assurance Mission, launched by Government of India. The mission should be able to integrate promotive, preventive and curative segments and include associated subjects like safe drinking water, sanitation and sustainable environment. Government must accord priority to collect demography and disease related data to support policy and plans," said Dr Girdhar J Gyani director general, Association of Healthcare Providers India (AHPI).In its review of National Health Policy 2015 (draft) along with KPMG, AHPI said that the government needs to collaborate to add more infrastructure such as healthcare set-ups at each delivery level to meet the demand of a growing population. Moreover, prioritize infrastructure development according to geographical needs. Commenting on the public health expenditure of the GDP which is proposed to be increased to 2.5 percent from the current share, AHPI said that the government should ensure effective utilization of existing budgets. It is imperative to achieve adequate distribution of the increased budget in areas of high priorities both strategically and geographically.AHPI says that the policy recognizes the problem of increasing OOP expenditure; advocates establishment of National Health Account system for normative resource allocation and payment mechanism and also suggests the reduction in healthcare cost borne by the poor in the private sector by using public insurance schemes. However, it recommends a discussion around universal health insurance for the masses and restructuring of government insurance scheme to ensure smooth implementation and implementation of transparent payment process.AHPI also suggests that the government look at the drug delivery model of Tamil Nadu and Rajasthan and urge other states to replicate the same.In his observation, Mr Nilaya Varma, partner, IGS-Advisory Management, KPMG in India said "today the Indian healthcare system stands at a cross-road. In the last one decade, even though Indian healthcare has taken leaps in terms of becoming a medical tourism destination, the delivery system both public and private, continues to remain elusive to the section of society with high healthcare needs. With efforts to meet health targets envisioned under Millennium Development Goals getting either off-track or dawdling, it becomes imperative for Indian healthcare stakeholders to revisit the policy and identify any gaps in the actions taken."ORDIUrging India to have a specific policy for the rare diseases, Mr Harsha K Rajasimha, entrepreneur and co-founder of the Organization for Rare Diseases India (ORDI) said, "Creating a better environment for rare disease diagnosis and treatment is necessary for equitable medical access. In that process, we can trigger advances also in other areas of medical research. A rare disease policy will help us to better manage this new aspect of medical care for our communities."In their review of the Health Policy (draft) submitted to government of India, ORDI has specified that by virtue of being rare diseases, they do not elicit the enthusiastic attention of researchers, medical practitioners and drug manufacturers. As a result, diagnosis is invariably delayed. In almost all cases, delays in diagnosis extend the suffering of patients and caregivers. Perhaps more importantly, the exclusion of rare diseases from the medical curricula in our country compounds the problem of diagnosis, research and development for patient care and its management, and for creating the infrastructure for diagnosis and treatment. In reality, there is considerable scope for rare disease investigation to enrich conventional medical research in areas such as personalized medicine. The need for an Orphan Drug Act (ODA) arises from the need to encourage awareness and incentivize manufacturers to develop drugs for rare diseases. Citing example from the US, ORDI said almost all orphan drug requirements in the US are covered by medical insurance. Additionally, in the US most companies have created a scope for reduced or zero fee provision of drugs for a limited number of needy patients. India need to replicate some of the best examples globally, it said.Further, ORDI recommends having a National database on rare diseases in India. Database monitoring would imply having a register that integrates details of rare disease drug manufacturers and rare disease medications and devices, research and development institutes, and consumers. ORDI also urge the government to integrate rare disease curriculum into medical education.Part of the solution to making rare disease treatment affordable is spreading the cost over the population. Medical insurance, which covers rare diseases, is one step in that process. This along with the mechanisms within an ODA for promoting research, drug manufacture and cross subsidy can help to dilute the intractable problem of affordability for rare disease patients, said ORDI.Welcoming the draft of the National Policy, Mr Javali Sudhir Pai, ED & CEO, Vikram Hospital, said "The draft National Health Policy 2015 (NHP) is path breaking in many ways. The goals are ambitious but sensible enough to address the need of the hour. Issues relating to high maternal mortality rate, infant mortality rate, malnutrition, burgeoning health care costs are a threat to economic survival of the nation as a whole. Major policy initiatives are needed to change this and "the policy addresses all the issues with a pragmatic approach."The emphasis on clinical trials and the need for it is a very good policy initiative. Encouraging clinical trials in India helps introduction of new products faster and access to drugs that are otherwise not available, though clinical trials will go a long way in saving lives of diseased. Asystem to ensure quick approval of clinical trials of new drugs is imperative to good health," he said.Speaking on the health policy, Mr Shrikant Ganduri, EVP and head - LifeSciences and IT Knowledge Banking, Yes Bank said, "National Rural Health mission (NRHM) to be used for effectively as an instrument for strengthening health system. NRHM free care to be extended to a larger set of diseases."Further he said, government should provide incentives to private healthcare providers to setup Healthcare delivery centers in rural areas. "The target of public spend of 2.5 percent for GDP, should be relooked as India-like countries like Brazil and Thailand have a higher public spend of 3-4 percent." "Health awareness agenda should be strengthened on the lines of brand campaigns like "Swacch Bharat Abhyan" and strict timelines based state wide access to free drugs and diagnostics has been done in states like Rajasthan and Tamil Nadu. India government should consider such programs," said Mr Ganduri.A policy is only as good as its implementation. Past policies have faced innumerable constraints in implementation. The National Health Policy therefore envisages that an implementation framework be put in place to deliver on these policy commitments. Such an implementation framework would specify approved financial allocations and linked to this measurable numerical output targets and time schedules.National Health Policy sets an ambitious target of healthcare expenditure at 2.5 percent of the GDP. This is an important benchmark as currently the healthcare expenditure is just 1.04 percent of GDP. Government has taken a bold and right step, hope it continuous. For the first part of the article, click here ]]> <![CDATA[Biocon's Glargine receives approval in Mexico]]> https://biospectrumindia.com/news/95/4115/biocons-glargine-receives-approval-in-mexico.html https://biospectrumindia.com/news/95/4115/biocons-glargine-receives-approval-in-mexico.html Thu, 09 Apr 2015 18:57:36 +0530 Mexico has been a very important market for Biocon since 2006, where it has been playing a significant role in enabling access to affordable rh-Insulin. Insulin Glargine will augment the affordable insulin therapy for diabetes management. 'GALACTUS' by PiSA is the first Insulin Glargine to be approved in Mexico as per the biocomparable approvals pathway defined in 2012. Biocon's presence in Mexico, over the last eight years, has expanded the insulins market substantially by initiating many more patients onto insulin therapy. The increasing affordability of Insulin Glargine will now enable Biocon and PiSA to expand this reach further. The combined market for Insulin Glargine in Mexico is estimated to be in excess of USD 40 million. Biocon's CMD Dr Kiran Mazumdar-Shaw commented, "....Our Insulin Glargine will now enable access to a basal insulin which will further expand the diabetes management therapy for patients in Mexico." Currently Biocon has marketing approvals in over 60 countries for rh-Insulin and in over 20 countries for Insulin Glargine. PiSA's group executive VP Lic. Santiago Alvarez Vega said: "We are extremely excited to partner with Biocon to introduce GALACTUS, the long acting insulin glargine in Mexico, which has a disease prevalence of 12 percent, the second highest in the world. We hope to enable the government to bring down its per capita expenditure on diabetes with the use of this cost effective, high quality biocomparable Insulin Glargine" Diabetes is a major health risk in Mexico, over 70% of the Mexican population is overweight thus prone to developing diabetes. With over 9 million cases of diabetes, it poses a huge disease burden for the government with per capita expenditure on diabetes being as high as USD 892.5. ]]> <![CDATA[Government halts funds for Greenpeace]]> https://biospectrumindia.com/news/95/7981/government-halts-funds-for-greenpeace.html https://biospectrumindia.com/news/95/7981/government-halts-funds-for-greenpeace.html Thu, 09 Apr 2015 18:10:23 +0530 The government has barred Greenpeace India from receiving foreign funds, alleging that it has prejudicially affected the economic interest of the state, says reports. Its registration under the Foreign Contribution Regulation Act or FCRA has also been suspended. Reportedly, seven of its bank accounts have been frozen with the government alleging that the organization deliberately under-reported foreign contributions and used them in part to fund legal cases. The government has also issued a showcause notice to the organization asking why it's registration should not be terminated. The organization said that the government had moved again to block its access to nearly 150,000 euros that were transferred to it on March 23. "Greenpeace is seeking legal advice in the matter as the Delhi high court in January had ordered that Greenpeace India be allowed to access funds sent by Greenpeace International," it said in a statement. ]]> <![CDATA[Govt allows pharma firms to hike prices of 509 essential drugs]]> https://biospectrumindia.com/news/95/6124/govt-allows-pharma-firms-to-hike-prices-of-509-essential-drugs.html https://biospectrumindia.com/news/95/6124/govt-allows-pharma-firms-to-hike-prices-of-509-essential-drugs.html Thu, 09 Apr 2015 14:40:19 +0530 The government has allowed pharmaceutical companies to hike rates of 509 essential medicines used for treating various ailments like diabetes, hepatitis and cancer by 3.84 percent, as per reports. The new pricing is effective from April 1. The National Pharmaceutical Pricing Authority (NPPA) has issued a notification for price hike of drugs in line with the wholesale price index of 2014 under Drug Price Control Order (DPCO), 2013. "As confirmed by the economic adviser (Minister of Commerce and Industry), the annual increase in the wholesale price index (WPI) works out at 3.84 per cent during calendar year 2014 over the corresponding period in 2013," NPPA said in a notification. Reportedly, The 509 medicines which have become costlier include Alpha Interferon injection used to treat hepatitis B and C as well as certain types of cancer, carboplatin injection used for cancer treatment and fluconazole capsules indicated for fungal infections, among others. According to the notification, antibiotics which have Amoxicillin capsules have also become costlier with effect from April 1. ]]> <![CDATA[Biocon Foundation wins 'WHOâ€“India Public Health Champion Award 2015']]> https://biospectrumindia.com/news/95/4108/biocon-foundation-wins-whoindia-public-health-champion-award-2015.html https://biospectrumindia.com/news/95/4108/biocon-foundation-wins-whoindia-public-health-champion-award-2015.html Thu, 09 Apr 2015 14:37:54 +0530 WHO-India recently instituted the 'Public Health Champions Awards' to recognize and encourage the efforts of individuals and institutions who have made an outstanding contribution to public health through advocacy, impactful health policies, strategies and programs thus leading to substantial improvement in health outcomes in India. The Foundation has been recognized for its integrated healthcare initiatives through which it is constantly engaged in improving the quality of life of several thousand communities in India. The 'Public Health Champion Award 2015' is a new initiative by WHO-India. Ms Rani Desai, head, Biocon Foundation, received the award from Dr Nata Menabde, WHO representative to India, at a function held in New Delhi. Dr Kiran Mazumdar, CMD, Biocon, said, "This is indeed a great recognition of the Foundation's tireless work in public health which brings great pride to everyone at Biocon. As an organization, we are always cognizant of the fact that we are in a humanitarian business of making a difference to human health and we continuously strive to deliver affordable access to underserved communities." The awards were presented at a national consultation held to commemorate the World Health Day 2015. Expressing her delight at receiving the award, Ms Rani Desai added, "The Foundation has been recognized for its innovative healthcare models of preventive and primary health services through which we are engaged in creating a sustainable health ecosystem. Through our primary health clinics we aim to enable access to affordable healthcare to rural and urban marginalized communities." Biocon Foundation has accelerated its efforts in the area of chronic diseases like diabetes and cancer, while continuing to work in the area of basic health. It has done path breaking work using low cost mHealth technologies to ensure that healthcare reaches the last mile in remote and underserved communities in a very cost effective manner. Highlighting the importance of this award, Dr Nata Menabde, WHO representative to India, expressed, "Public health is a challenging field and these awards are our way of saying 'thank you' to the talented individuals and organizations that have dedicated themselves to this field. These awards are an attempt to recognize and honor the best in this field and also to encourage others to emulate them." ]]> <![CDATA[Merck, Pfizer to co-market potential cancer drug]]> https://biospectrumindia.com/news/95/4201/merck-pfizer-to-co-market-potential-cancer-drug.html https://biospectrumindia.com/news/95/4201/merck-pfizer-to-co-market-potential-cancer-drug.html Thu, 09 Apr 2015 11:58:11 +0530 Merck and Pfizer have decided to co-promote Pfizer's anaplastic lymphoma kinase (ALK) inhibitor Xalkori (crizotinib), ALK inhibitor approved in the United States, Japan and the European Union (EU) and is supported by two positive global randomized trials in the first and second line ALK-positive advanced non-small cell lung cancer (NSCLC) treatment settings. The alliance is to establish a combined oncology sales organization in key markets in advance of the potential launch of avelumab-based treatment regimens in the future. Under the agreement, Xalkori will be co-promoted in two waves, the first of which will begin in the second and third quarters of 2015 in the United States, Canada, Japan and five European Union countries (France, Germany, Italy, Spain and the United Kingdom). In the United States and Canada, XALKORI will be co-promoted by EMD Serono, the US and Canadian biopharmaceutical businesses of Merck. The second wave will begin in 2016 and includes China and Turkey. In 2015, Merck will receive a reimbursement associated with its promotion of Xalkori, followed by an 80 percent (Pfizer), 20 percent (Merck) profit sharing on the product starting in 2016. The co-promotion term will last through December 31, 2020 for the United States, Canada, Japan, France, Germany, Italy, Spain and the United Kingdom and from January 1, 2016 through December 31, 2021 in China and Turkey. Pfizer will report the sales of Xalkori in countries where it is co-promoted with Merck. "We are proud and excited to share the legacy of Xalkori, a medicine that changed the treatment paradigm for patients with ALK-positive metastatic NSCLC, with Merck," said Ms Liz Barrett, president and general manager, Pfizer Oncology. "Through our co-promotion of Xalkori, we will establish a best-in-class global sales organization that will be exceptionally prepared for the potential launches of our future oncology medicines." "As we progress our robust program to co-develop and co-commercialize avelumab, the co-promotion agreement is an exciting milestone for the alliance between Merck and Pfizer, allowing us to establish our combined oncology sales organization in key markets for the program," said Dr Andrew Schiermeier, general manager for the Merck-Pfizer Alliance and head of global oncology, adding, "For Merck, this agreement is particularly important as it accelerates the establishment of our United States and Canada oncology sales organization ahead of our potential avelumab launches and positions us for future success in this market." ]]> <![CDATA[AIMED welcomes recommendations of task force on medical devices]]> https://biospectrumindia.com/news/95/5356/aimed-welcomes-recommendations-of-task-force-on-medical-devices.html https://biospectrumindia.com/news/95/5356/aimed-welcomes-recommendations-of-task-force-on-medical-devices.html Thu, 09 Apr 2015 11:04:34 +0530 Mr Rajiv Nath, forum coordinator, AIMED has welcomed the recommendations of the task force on medical devices released by minister, Mr Anant Kumar. Mr Nath said that the recommendations announced at this path breaking event will set the ball rolling to make India a powerhouse in manufacturing of medical devices and if implemented quickly, it will certainly be a milestone to help the country reduce its humungous import dependency in this sector. He said that in particular Task Recommendation to reverse duty bias against domestic goods, recommendation to form a separate department for medical devices, and to have a separate legislation for medical device sector was of particular significance for the country as well this sector. Mr Nath has thanked Mr Ananth Kumar, union minister for chemicals and fertilizer and Mr V Suburaj, secretary of the dept for this brilliant recommendations. It may be noted that to realize the vision of PM Modi's vision of 'Make in India', department of chemicals and fertilizers had set up three task force, among which one was on 'Promotion of Domestic Production of High End Medical Devices and Pharmaceutical Manufacturing Equipment'. The recommendation of this task force was released today by Shri Ananth Kumar. ]]> <![CDATA[Govt approves foreign investments in two Indian pharma firms]]> https://biospectrumindia.com/news/95/5354/govt-approves-foreign-investments-in-two-indian-pharma-firms.html https://biospectrumindia.com/news/95/5354/govt-approves-foreign-investments-in-two-indian-pharma-firms.html Thu, 09 Apr 2015 11:01:00 +0530 The Cabinet Committee on Economic Affairs (CCEA), chaired by the Prime Minister Mr Narendra Modi, on April, 07 approved two significant foreign investments in the pharmaceutical sector. Aurobindo Pharma are engaged in manufacturing generic pharmaceuticals and active pharma ingredients, and approvals have been given for Qualified Institutional Buyers to infuse fresh equity of upto 7 percent amounting to about Rs 2165 crore into the company. The existing FII shareholding is 27.32 percent in the company. This will enable the company to expand its operations in the areas of anti infective, cardiovascular and central nervous system related ingredients. Aurobindo Pharma employs more than 9500 professionals from 26 countries. Glenmark Pharmaceutical has increased the foreign investment limit by FIIs from 35.07 percent to 49 percent. This will result in an inflow of about Rs 2022 crore. Apart from manufacturing pharmaceuticals, the company is also engaged in Research and Development activities in drugs. Glenmark Pharmaceuticals is a $1 billion Indian pharmaceutical company, with a global presence with manufacturing facilities in India, Europe and South America. Both companies are promoted by Indian entrepreneurs who have developed a global footprint over the years. The companies are required to continue to produce medicines under the National List of Essential Medicines (NLEM) at the same levels as they had been doing in the past. These companies are also required to maintain R&D expenditure at the maximum levels incurred in the past three years and to provide complete information regarding transfer of technology that has been done. This underscores the importance given by the Government to strengthening healthcare in the country, by ensuring availability of drugs to the people at reasonable prices. These investments show the continued confidence of international investors in the domestic Intellectual Property Regime in the pharmaceutical sector. By investing in Research and Development, these companies have become players in the global pharmaceutical market and exemplify "Make in India" which is being promoted by the Government of India. ]]> <![CDATA[Make in India push: govt to establish medical devices parks]]> https://biospectrumindia.com/news/95/5367/make-in-india-push-govt-to-establish-medical-devices-parks.html https://biospectrumindia.com/news/95/5367/make-in-india-push-govt-to-establish-medical-devices-parks.html Thu, 09 Apr 2015 10:58:24 +0530 The government is going to set up medical devices parks in the country, and first such park will come up in Gujarat soon. This was stated by the union minister of chemicals and fertilizers, Mr Ananth Kumar while releasing the recommendations of the Task Force on Promotion of Domestic Production of High End Medical Devices & Pharmaceutical Manufacturing Equipment on April,08 at New Delhi. Mr Kumar mentioned that only 30 percent of the country's requirement of medical devices is being met through indigenous production, and that of low end category. The Minister said that the government is taking several steps to boost the domestic production of high end medical devices & pharmaceutical manufacturing equipment. He said that NIPER, Ahmedabad will be the nodal institute for undertaking research and development in the area. Mr Ananth Kumar said that the recommendations made by the Task force will be implemented in a time bound manner. He said that the department has already taken up issues of incentives and taxation on such devices with the finance ministry so that the indigenously produced medical devices can compete with the imported ones. The minister said that the need is being felt to have a separate department to handle the issues of facilitation and regulation of high end medical devices & pharmaceutical manufacturing equipment, as their consumption is increasing very fast and there is need to make India self-dependent in the sector. He said that on the lines of National List of Essential Medicines, there should be a National List of Essential Medical Devices to enable providing affordable, quality products to masses easily. The Task Force has given recommendations to address concerns and constraints facing the sector and suggested measures that would augment domestic production of medical devices. The Task Force has recommended measures to enhance policy and institutional support; suggested strengthening of infrastructural support; and, recommended fiscal and financial support to the sector. In addition, the Task Force has also recommended measures for creating an institutional set-up for efficacy & safety testing, promoting skill development aligned to the need of the industry, strengthening the R&D Capability of the sector, pricing strategy for the sector and conducive regulatory environment. ]]> <![CDATA[India to lead APAC non-vascular stents market by 2021]]> https://biospectrumindia.com/news/95/4119/india-to-lead-apac-non-vascular-stents-market-by-2021.html https://biospectrumindia.com/news/95/4119/india-to-lead-apac-non-vascular-stents-market-by-2021.html Thu, 09 Apr 2015 09:12:00 +0530 According to a recent study by research and consulting firm GlobalData, the APAC non-vascular stents market consisting of urinary tract, pancreatic and biliary, enteral, and airway stents, will expand in value from $148.1 million in 2013 to $223.8 million by 2021, growing at a Compound Annual Growth Rate (CAGR) of 5.3 percent. GlobalData elaborated in its report that key APAC countries like India, Japan and China will experience massive growth in this area, with India leading the race. The firm said that the Indian market value for non-vascular stents will increase at a CAGR of 6 percent. Ms Priya Radhakrishnan, GlobalData's director for Medical Devices, said in a statement, "India is set to overtake China in becoming the world's most populous country around 2020, leading to a significant patient base and rapidly-expanding medical device market." She added that the flexibility of manufacturers with respect to the use of stents, such as employing a pay-as-you-go model, will be hugely important in driving India's non-vascular stent market in the future. The director also said that few factors such as minimal penetration of these technologies in rural areas and low awareness among public may hamper this growth. Ms Radhakrishnan further explained, "Rural areas and smaller cities are still underserved with respect to stenting procedures, and are awaiting the most current technologies' arrival. India's market remains challenging for multinational corporations to penetrate, with unstable distribution networks and the prominence of low-cost manufacturers. In a country with high procedure volumes, local manufacturers can produce products at a third of multinationals' costs, allowing them to compete directly with foreign companies." ]]> <![CDATA[Bristol-Myers Squibb join hands with uniQure]]> https://biospectrumindia.com/news/95/3909/bristol-myers-squibb-join-hands-with-uniqure.html https://biospectrumindia.com/news/95/3909/bristol-myers-squibb-join-hands-with-uniqure.html Wed, 08 Apr 2015 14:52:42 +0530 Bristol-Myers Squibb and uniQure has announced an agreement that provides the company exclusive access to uniQure's gene therapy technology platform for multiple targets in cardiovascular diseases. The collaboration includes uniQure's proprietary gene therapy program for congestive heart failure that is intended to restore the heart's ability to synthesize S100A1, a calcium sensor and master regulator of heart function, and thereby improve clinical outcomes for patients with reduced ejection fraction. Beyond cardiovascular diseases, the agreement also includes the potential for target-exclusive collaboration in other disease areas. In total, the companies may collaborate on ten targets, including S100A1. uniQure will lead discovery efforts and be responsible for manufacturing of clinical and commercial supplies using its vector technologies and its industrial, proprietary insect-cell based manufacturing platform. Bristol-Myers Squibb will lead development and regulatory activities across all programs and be responsible for all research and development costs. Bristol-Myers Squibb will be solely responsible for commercialization of all products from the collaboration. Dr Carl Decicco, head of discovery, R&D, Bristol-Myers Squibb said, "Collaborating with uniQure, a clear leader in the field with an innovative and validated gene therapy platform, further strengthens our capability to bring forward transformational new therapeutics for difficult-to-treat diseases, including cardiovascular diseases such as heart failure." "Bristol-Myers Squibb's strength in the cardiovascular area and its commitment to gene therapy will allow them to leverage the full breadth and capacity of our platform for cardiovascular diseases," said Mr Joern Aldag, CEO, uniQure. "This collaboration will accelerate the application of gene therapy for large patient populations suffering from heart diseases and will complement the further development of uniQure's internal pipeline in two focus areas: liver diseases, including hemophilia, and CNS, including lysosomal storage diseases." Under the terms of the agreement, Bristol-Myers Squibb will make near-term payments of approximately $100 million, including an upfront payment of $50 million to be made at the closing of the transaction, a $15 million payment for the selection of three collaboration targets, in addition to S100A1, to be made within three months of the closing and an initial equity investment in uniQure for a number of shares that will equal 4.9% of the total number of shares outstanding following such issuance, at a purchase price of $33.84 per share, or at least $32 million in total. Bristol-Myers-Squibb will acquire an additional 5 percent ownership before December 31, 2015, at a 10 percent premium, and will be granted two warrants to acquire up to an additional 10 percent equity interest, at a premium, based on additional targets being introduced into the collaboration. The parties have also agreed to enter into a supply contract, under which uniQure will undertake manufacturing of all gene therapy products under the collaboration. uniQure and Bristol-Myers Squibb anticipate the collaboration to be effective during the second quarter of 2015. The effectiveness of the transaction is subject to customary closing conditions, including clearance under the Hart-Scott-Rodino Antitrust Improvements Act. The initial issuance by uniQure of equity to Bristol-Myers Squibb also is anticipated to close in the second quarter of 2015 and is subject to the approval by the shareholders of uniQure. ]]> <![CDATA[Approval for new Bt cotton events: EBAM committee meets next week]]> https://biospectrumindia.com/news/95/6123/approval-for-new-bt-cotton-events-ebam-committee-meets-next-week.html https://biospectrumindia.com/news/95/6123/approval-for-new-bt-cotton-events-ebam-committee-meets-next-week.html Wed, 08 Apr 2015 13:59:00 +0530 After it asked the companies to send applications for allowing the commercial release of their Bt cotton hybrids, the Standing Committee authorized to take call on the matter, is set to issue go aheads in its next meeting scheduled to be held on April, 15. The committee is a part of the Event Based Approval Mechanism system of Review Committee of Genetic Manipulation (RCGM) whose secretariat is located at the department of biotechnology (DBT) in New Delhi. Earlier the applicants were asked to submit their applications for a maximum of two Bt cotton hybrids per applicant per State/Zone may be submitted for North, Central and South Zones by April, 06. However, it has also warned the applicant companies that punitive action will be initiated in case of providing any wrong information/declaration on any of the points for which details were sought. These included: 1. Confirmation of gene/event through molecular characterization by the licensor stating that the gene/s being used is one of the approved events (LOC in original)2. Level of protein expression in green house and field trials3. Morphological characters using DUS descriptors as per PPVF&RA guidelines for the hybrids as well as parental lines4. Bio-efficacy data generated in laboratory conditions5. Authorization certificate/ No Objection Certificate (NOC) in original from technology provider in case of sub-licensee6. Affidavits duly signed by the Notary on Stamp Paper7. Each application shall contain data pertaining to single hybrid only as inclusion of a lot of hybrids in a single application causes hardship in evaluation of the data; Individual application should be submitted for each State/Zone; Applications submitted earlier/pending cases of earlier Standing Committee meetings will not be considered.8. Field trial data of the particular hybrid at least from one SAU per State of the particular Zone; In addition to yield parameters, the data should include the quality aspects as well as reaction of test hybrid against insects and diseases as recorded under AICCIP; Seed cotton yield should be significantly superior to the best check.9. For Central and South Zones, the SAU data may be provided keeping in view of the rainfed/irrigated regions and may be submitted for both regions to ensure approval for the entire State10. Number and names of hybrids approved under EBAM so far for each State, name of hybrids available in the market, and how the proposed hybrids are better than the approved hybrids11. Data on tolerance of Bt cotton hybrids to CLCuV in North Zone (only for hybrids to be released in North Zone) as evaluated by SAU Centre in North Zone/CICR, Sirsa12. Current status of Bt cotton hybrids approved by Standing Committee under EBAM for commercialization ]]> <![CDATA[Should India look towards Biomass Electricity?]]> https://biospectrumindia.com/views/95/4515/should-india-look-towards-biomass-electricity.html https://biospectrumindia.com/views/95/4515/should-india-look-towards-biomass-electricity.html Wed, 08 Apr 2015 09:34:00 +0530 To make India a "renewable superpower", the new government has encouraged and incentivized the wind and solar energy sector with ambitious targets. However, biomass has not received similar attention. Past failures could have caused this lack of enthusiasm towards bioenergy; over 60 percent of existing grid-connected biomass plants are not functional. A major problem is large plant size (5-20 MW) which makes it difficult to get the required amount of feedstock. Without assured feedstock supply, bioenergy producers find it difficult to convince banks to finance them. Experts at the Indian Institute of Science (IISc) say that smaller plants ( < 2 MW) with lower feedstock needs can solve this challenge. However, even small-scale projects haven't seen success. In 2001, a UNDP funded project in Karnataka aimed to install twenty four gasifiers. Eleven systems were installed, and today only one is functional. The systems weren't sustainable because, electricity production costs were Rs 4-6 per unit, but buy-back tariffs were only Rs 3-4 per unit. The situation hasn't improved much. Though the center recommends tariffs of Rs 6-7 per unit for biomass gasifiers, states offer only Rs 4-5 per unit. Ms Tamara Law Billimoria, a biomass-based consultant and researcher, reveals that many petitions have been filed to State Electricity Regulatory Commissions (SERC). However, state regulators haven't given enough thought to how exactly power production costs play out versus selling prices for that power in the Indian RE market. She concludes by saying that, despite biomass-based power being an important sustainable source of energy at the grass-root level of our agrarian economy, it isn't given enough leverage by policy makers.The case for bioenergy Bioenergy's biggest advantage is that unlike wind and solar energy, it isn't variable. In energy-starved states, it can complement variable resources to meet electricity needs. Bioenergy can be conveniently scheduled in advance by utilities. India's large local experience in biomass technologies, implies low import dependence and could make the country a bioenergy equipment export hub, thus catering to the "Make in India" aspiration. Benefits of bioenergy include employment and income creation within the agricultural sector. Research at CSTEP shows that 1 GW of installed gasification capacity could create over 70,000 direct and indirect jobs.Indian Institute of Tropical Meteorology's recent report shows that open burning of biomass residues causes significant pollution in India. Using these agricultural residues for electricity generation could lower 25-50 percent of the total CO and NO2 emissions in the country.As bioenergy provides broader social and economic benefits in addition to reliable electricity, it is an option certainly worth exploring. However, while seeking a solution, caution must be taken not to encroach on useful land and crop use. The World Resource Institute (WRI) strongly encourages using surplus residue and fallow land for producing biomass feedstock. Keeping this in mind, the following suggestions have been made. Learning from the past and the way forwardCurrently, most biomass plants are dependent on forestry or agricultural residues. Woody residues are difficult to procure from Forest Departments and agro-wastes are often used by other businesses. Ms Aklavya Shravan of DESI Systems, says that his organisation tries to meet partial feedstock needs (30-40 percent) through inter-cropped energy plantations. Hardy species such as Melia Dubia and Subabul are grown, and crops like chillies and garlic are grown below. Mr Jai Rathod from the Natural Group said that higher-yielding species such as Beema bamboo, could also be grown but they have high water requirements. Fortunately, these demands can be met with water from Effluent Treatment plants and sewage. With increased research in this sector, he predicts that these land requirements will go down. IISc estimates that around 40 million hectares of wasteland in India is available for these plantations. An important first step would be to conduct a more detailed national assessment before utilising these lands for biomass. The survey will ideally capture residue availability and identify suitable wastelands for plantations of different species. The possibility of briquetting agro-residues should also be explored. The only assessment made on a nation-wide scale by IISc, is a decade old and doesn't have plantation potential. A 1 MW solar, wind and bioenergy gasifier power plant with captive plantations would require a minimum area of five, thirty (assuming inter-turbine space is unutilized) and two hundred acres respectively. Mr Jai Rathod explained how even though land requirements for plantations are relatively high, the positive impacts compensate. Other than adding significantly to the upliftment of local communities, plantations could offer advantages similar to afforestation on degraded land. A stance similar to the Karnataka Solar Policy 2014 can be adopted, where farmers lease out waste/barren lands to solar companies. Farmers can lease their unutilized barren lands to private companies, who can set up captive feedstock plantations for small-scale biomass plants on a long-term basis. Ms Billamoria recommended that these lands be harvested in a mixed use scheme. Most government funded projects have poor after-sales maintenance but several NGOs report success stories due to community participation. Hence, biomass training programs for should be implemented. The long disbursal times of capital subsidies make investors not keen to solely rely on them. Hence, incentives which reward generation should be introduced. Models involving rural entrepreneurs, Electricity Supply Companies (ESCOMs), community ownership, and collaboration amongst these stakeholders should be promoted. Depending on the model, appropriate soft loans can be granted. Biomass plants are eligible for 80 percent Appreciated Depreciation (AD) in the first year. However, AD benefits for biomass plants are not effective because biomass electricity producers tends to be small ventures, which do not have large profits. To ensure a level playing field, schemes where AD benefits can be traded should be introduced. Supportive policies, national assessments and robust after-sales mechanisms will ensure that bioenergy contributes in making India a "renewable superpower". ]]> <![CDATA[National Health Policy 2015: What is in it for you?]]> https://biospectrumindia.com/features/95/5848/national-health-policy-2015-what-is-in-it-for-you.html https://biospectrumindia.com/features/95/5848/national-health-policy-2015-what-is-in-it-for-you.html Wed, 08 Apr 2015 09:19:00 +0530 It has been over 30 years since the government committed to health for all. It is 2015 now and the new NDA government at the center has released a draft of the new Health policy 2015. The new goal set by the 2015 draft is "The attainment of the highest possible level of good health and well-being, through a preventive and promotive health care orientation in all developmental policies, and universal access to good quality health care services without anyone having to face financial hardship as a consequence." There is not much change in the goals of 1983 and 2015, yet we have completed 32 years with limited success.Repeated studies have shown that in spite of the free public health system, people are spending a lot from their pocket. According to CII (Confederation of Indian Industry) this is also due to the fact that the share of the government in total health expenditure in India is very less. It is estimated that the Government spend accounts for about 22 percent of the total healthcare spend in the country. More than 60-70 percent of the health expenditure comprises of un-pooled, out-of-pocket expenditures. This compares adversely with the world average of 16 percent out-of-pocket expenses and 32 percent government spends within the total healthcare expenditure. India stands quite low when compared to both developed and developing countries. According to the Ministry of Health and family welfare, Government of India, this National Health Policy addresses the urgent need to improve the performance of health systems. It is being formulated in the last year of the Millennium Declaration and its Goals, in the global context of all nations committed to moving towards universal health coverage. Given the two-way linkage between economic growth and health status, this National Health Policy is a declaration of the determination of the Government to leverage economic growth to achieve health outcomes and an explicit acknowledgement that better health contributes immensely to improved productivity as well as to equity. In its memorandum, FICCI, India's leading business association has said the draft National Health Policy (NHP) 2015, in the public domain since 30th December, 2014, has indeed a progressive policy outlook. It recognizes the public health system as distinct from health services, human resources, and investment. However, the Ministry of Health and Family Welfare needs to articulate a Vision 2030, with respect to the health profile of India on the lines of Sustainable Development Goals of the UN. FICCIFICCI suggests following measures to improve the healthcare of citizens:-The national movement for Swachh Bharat can surely be viewed also as a pitch for Swastha Bharat, as in fact it comprises a series of public health initiatives towards implementing preventive and promotive health. FICCI recommends opening up a fourth layer of health care, which may be called 'pre-primary', which will democratize all tasks and activities relating to prevention and promotion.An effective national healthcare system and therefore an efficient and effective National Health Policy will ride faster and smoother on the back of a strong Digital India campaign. Seamless mobility of patient health data and electronic medical records are among the most significant outcomes that Digital India could yield. India now has more than 90 crore mobile phones, more than 60 crore Aadhaar numbers and more than 10.5 crore Jan Dhan Yojana accounts. This combination of Jan Dhan Yojana, Aadhaar and Mobile phones (JAM) could be a very potent instrument to reach out to the most rural household. The transfer of funds will promote more regular visits to health care facilities and purchase of essential medicines for overall well-being.The Make in India campaign seeks to channelize the entrepreneurial spirit of young India in order to increase the degree of self-reliance in the country. FICCI recommends creation of a sustainable ecosystem to institutionalize innovation via pro-active collaboration between government, academia and industry for design and innovation in medical technology. Skill India seeks to create a skilled task force to meet the rapidly growing requirements of all sectors of economy. The health sector is among the largest employer of skilled human capital and therefore a critical partner in the nation-wide program for enhancing the skill levels of citizens. There is a need for convergence and collaboration between MoHFW, Healthcare Sector Skills Council, Medical Council of India and vocational training providers in healthcare sectors, and spell out a roadmap, moving forward. Further, the overlaps and duplication of responsibility for healthcare amongst various ministries viz Ministry of Women and Child Development, Ministry of Education, Ministry of Information and broadcasting, Ministry of Science and Technology, Ministry of Labour and Employment, and Department of Pharmaceuticals needs to be addressed and rationalized for greater transparency and accountability.Following the maxim of minimum government and maximum governance, the NHP 2015 needs to articulate a rapid roadmap for legislative, institutional, and financial reform, so that the regulatory framework catches up with ground reality. We need to have statutory norms in place for regulating infra-structure, clinical practice and medical service standards. NHP 2015 should direct that the Clinical Establishment Act 2010 be re-examined, modified where necessary, and re-enacted such that it becomes applicable to the whole country, across the public and private sectors. Further, State governments should be encouraged to create a single window clearance system where people desirous of starting a healthcare related business should apply online only, and on the lines of Passport e Seva.Since Health remains a state subject, very often the central government is unable to push through an agenda common to all states. It is not always easy to roll out major national programs, campaigns and initiatives, therefore NHP 2015 should pursue removal of health care from the State List to be placed on the Concurrent List in the Seventh Schedule of the Constitution. FICCI supported MoHFW to develop standard treatment guidelines (STGs) across 20 specialities in 2009. To this day, these have perhaps not been notified because they have not been adopted by healthcare providers. In the event that disease control is put under the Concurrent List, development and adoption of these STGs would be easier. Additionally, if functions relating to quality accreditation and pharmaceuticals are placed in the Concurrent List, this will facilitate universal application of standards by central and state health ministries and departments. Read the continuation...here ]]> <![CDATA[Antipsychotics may increase diabetes risk in some children]]> https://biospectrumindia.com/news/95/3674/antipsychotics-may-increase-diabetes-risk-in-some-children.html https://biospectrumindia.com/news/95/3674/antipsychotics-may-increase-diabetes-risk-in-some-children.html Wed, 08 Apr 2015 09:09:00 +0530 Researchers from The Children's Hospital of Philadelphia's (CHOP) PolicyLab published the largest study to date documenting the significant risks to children's health associated with prescription antipsychotics, a powerful class of medications used to treat mental and behavioral health disorders. The results suggest that initiating antipsychotics may elevate a child's risk not only for significant weight gain, but also for type II diabetes by nearly 50 percent; moreover, among children who are also receiving antidepressants, the risk may double. Previous PolicyLab research showed that one in three youth receiving antidepressants in the Medicaid program were receiving an antipsychotic at the same time. Traditionally, antipsychotics have been narrowly prescribed to children with a diagnosis of schizophrenia or bipolar disorder, or to those with significant developmental delays who were displaying aggressive behaviors that were potentially injurious to themselves or others. However, in recent years, these medications are increasingly being prescribed in the absence of strong supporting safety and efficacy data to treat healthier children and adolescents with disruptive behaviors, such as those who are diagnosed with attention deficit hyperactivity disorder (ADHD). "With such vast numbers of children being exposed to these medications, the implications for potential long-lasting harm can be jarring," said Dr David Rubin, the study's lead author and co-director of PolicyLab at CHOP. "Although these findings should certainly give us pause," Dr Rubin added, "we should not reflexively over-react to them. Rather, we need to incorporate these new revelations about the risk for diabetes into a more thoughtful consideration of the true risks and benefits of prescribing an antipsychotic to a child. Yes, we should try, by all means possible, to minimize the numbers of children and adolescents exposed to these powerful medications. But for some children in immediate crisis, we must also concede that the benefit of the antipsychotic for acute management may still outweigh the risk." "At the end of the day, the approach to the individual child who is in crisis is still a case-by-case decision between a family and the treating provider," said Dr Rubin. ]]> <![CDATA[BMS, uniQure collaborate to develop gene therapies for CVDs]]> https://biospectrumindia.com/news/95/6506/bms-uniqure-collaborate-to-develop-gene-therapies-for-cvds.html https://biospectrumindia.com/news/95/6506/bms-uniqure-collaborate-to-develop-gene-therapies-for-cvds.html Tue, 07 Apr 2015 14:21:33 +0530 The companies anticipate the collaboration to be effective during the second quarter of 2015. The collaboration includes uniQure's proprietary gene therapy program for congestive heart failure that is intended to restore the heart's ability to synthesize S100A1, a calcium sensor and master regulator of heart function, and thereby improve clinical outcomes for patients with reduced ejection fraction. Beyond cardiovascular diseases, the agreement also includes the potential for target-exclusive collaboration in other disease areas. In total, the companies may collaborate on ten targets, including S100A1. uniQure will lead discovery efforts and be responsible for manufacturing of clinical and commercial supplies using its vector technologies and its industrial, proprietary insect-cell based manufacturing platform. BMS will be solely responsible for commercialization of all products from the collaboration. Mr Joern Aldag, CEO, uniQure, said, "This collaboration will accelerate the application of gene therapy for large patient populations suffering from heart diseases and will complement the further development of uniQure's internal pipeline in two focus areas: liver diseases, including hemophilia, and CNS, including lysosomal storage diseases." Under the terms of the agreement, Bristol-Myers Squibb will make near-term payments of approximately $100 million, including an upfront payment of $50 million to be made at the closing of the transaction, a $15 million payment for the selection of three collaboration targets, in addition to S100A1, to be made within three months of the closing; and an initial equity investment in uniQure for a number of shares that will equal 4.9 percent of the total number of shares outstanding following such issuance, at a purchase price of $33.84 per share, or at least $32 million in total. BMS will acquire an additional 5.0 percent ownership before December 31, 2015, at a 10 percent premium, and will be granted two warrants to acquire up to an additional 10 percent equity interest, at a premium, based on additional targets being introduced into the collaboration. The parties have also agreed to enter into a supply contract, under which uniQure will undertake manufacturing of all gene therapy products under the collaboration. uniQure will be eligible to receive research, development and regulatory milestone payments, including up to $254 million for the lead S100A1 therapeutic and up to $217 million for each other gene therapy product potentially developed under the collaboration. The company is also eligible to receive net sales based milestone payments and tiered single to double-digit royalties on product sales. ]]> <![CDATA[FDA nod for Glenmark's new generic drug]]> https://biospectrumindia.com/news/95/3087/fda-nod-for-glenmarks-new-generic-drug.html https://biospectrumindia.com/news/95/3087/fda-nod-for-glenmarks-new-generic-drug.html Tue, 07 Apr 2015 12:17:00 +0530 Glenmark Generics has been granted the final abbreviated new drug approval (ANDA) from the United States Food and Drug Administration (US FDA) for Norethindrone Acetate and Ethinyl Estradiol Tablets USP, 0.5 mg/2.5 mcg and 1 mg/5 mcg. Glenmark will commence distribution of the product immediately. These tablets are Glenmark's generic version of Warner Chilcott's FemHRT. The drugs are indicated for the treatment of moderate to severe vasomotor symptoms due to menopause and for the prevention of postmenopausal osteoporosis in women at significant risk of osteoporosis. For the 12 month period ending February 2015, the FemHRT market garnered annual sales of $38.6 million, according to IMS Health. ]]> <![CDATA[Quest Life Sciences buys Fortis Clinical Research]]> https://biospectrumindia.com/news/95/3907/quest-life-sciences-buys-fortis-clinical-research.html https://biospectrumindia.com/news/95/3907/quest-life-sciences-buys-fortis-clinical-research.html Tue, 07 Apr 2015 12:09:38 +0530 Chennai-based clinical research organization Quest Life Sciences Pvt Ltd has made a strategic acquisition. The company has acquired the assets of Fortis Clinical Research Ltd (FCRL), a division of Fortis Hospitals Group, which is promoted by Mr Malvinder Singh and Mr Shivinder Singh. Fortis Clinical Research provides clinical research services to the pharmaceutical, biotechnology and device companies across the globe. The company has accreditations from USFDA, ANVISA, Turkey, UK MHRA, WHO, etc. FCRL has an established Bioavailability/Bioequivalence (BA/BE) studies centre in Faridabad, India. FCRL primarily served Ranbaxy for its submissions and approvals. With the complete takeover of Ranbaxy by Sun Pharma, Fortis decided to divest FCRL. With global expertise in clinical trials services, Quest Life Sciences purchased the entire assets of FCRL to expand its presence and services. Quest is setting up a state-of-the-art BA/BE centre in the Special Economic Zone of Kandla, Gujarat, which is likely to be commissioned by June 2015. Mr T S Jaishankar, Managing Director, Quest Life Sciences P Ltd, Chennai informed BioSpectrum bureau that their present capacity in Chennai is almost fully utilized and the establishment at Kandla has been primarily initiated because of the speed and single window clearance of the Gujarat Government. The construction is nearing completion and hence FCRL acquisition has been at the most opportune time. Quest Life Sciences offers a full array of clinical trial services, having extensive experience in conducting PK/PD studies. The company offers complete range of ICH GCP compliant services for phase I to IV clinical trials and delivers cost effective, timely research solutions to the pharmaceutical industries worldwide. Quest Life Sciences have been audited 5 times by USFDA besides MHRA UK, Spanish Govt, AEMPS, MOH Malaysia, etc. Besides Kandla and Chennai, Quest has offices in New Jersey, USA, Moscow and Bangkok. ]]> <![CDATA[Govt to establish two new agriculture research institutes soon ]]> https://biospectrumindia.com/news/95/6238/govt-to-establish-two-new-agriculture-research-institutes-soon-.html https://biospectrumindia.com/news/95/6238/govt-to-establish-two-new-agriculture-research-institutes-soon-.html Tue, 07 Apr 2015 11:24:42 +0530 Union agriculture minister has urged initiatives towards bringing Green Revolution and increasing agriculture productivity to eastern region Inaugurating a workshop on "Agriculture Scenario in Eastern India, Review and Future Prospects", in Pusa, New Delhi on April 06, Mr Singh said that proper care has to be taken by balanced usage of fertilisers in bringing 2nd Green revolution, particularly in eastern region of the country. He emphasised that indiscriminate use of the urea and chemical fertilisers may be avoided. He underlined the importance of organic farming taking into consideration the ecological aspects. Agriculture minister said that for the first time, soil health card is being implemented in Mission Mode and every farmer of the country will be provided with Soil health card in next three years and they will be empowered with complete details about soil nutrient for effective crop management. Mr Singh emphasised for making available high quality seeds and agriculture plantatioin material to farmers for increasing productivity. He said that Front Line extension and Field extension of agriculture should work in syngery. He said that Agricultural Technology Management Agency should play an important role in this respect. During the Program, he emphasized on the initiatives of the Central Government like the Soil Health Management System, Soil testing laboratories, 'Pradhan Mantri Krishi Sinchai Yojana', Unified National Agriculture Market and 'Paramparagat Krishi Vikas Yojana'. He said that increasing productivity is important along with proper marketing facilities for the agricultural crops. He emphasised that districts in the country have an important role during the planning and implementing initiatives like 'Pradhan Mantri Krishi Sinchai Yojana'. He said that Prime Minister vision of 'Per Drop More Crop' can be realized by proper coordination between the Centre and the States. During his address, he urged the Small Farmers' Agriculture-Business Consortium to support farmers and formation of more 'Farmer Producer Organization' for the development of farmers. Present on the occasion were secretary, Department of Agriculture and Cooperation, additional secretary and financial advisor, joint secretaries along with senior officials of state governments and experts from agriculture sector. ]]> <![CDATA[Dr Mazumdar-Shaw: ABLE's new non-executive chairman]]> https://biospectrumindia.com/news/95/3903/dr-mazumdar-shaw-ables-new-non-executive-chairman.html https://biospectrumindia.com/news/95/3903/dr-mazumdar-shaw-ables-new-non-executive-chairman.html Tue, 07 Apr 2015 11:22:46 +0530 Dr Kiran Mazumdar-Shawm, chairman and managing director of Biocon, has been elected as the first non-executive chairman of Association of Biotechnology Led Enterprises (ABLE) in an honorary capacity. Dr Shaw also chairs Karnataka's Vision Group on Biotechnology and also serves on the advisory council of the Government's Department of Biotechnology. Mr PM Murali, managing director and CEO of Evolva Biotech, was re-elected as the president for a second term. Reportedly, the new office bearers will serve in their new positions for three years from 2015 to 2018. ]]> <![CDATA[India to host SAARC health ministers shortly ]]> https://biospectrumindia.com/news/95/6125/india-to-host-saarc-health-ministers-shortly-.html https://biospectrumindia.com/news/95/6125/india-to-host-saarc-health-ministers-shortly-.html Mon, 06 Apr 2015 13:05:46 +0530 Mr JP Nadda, union minister of health and family welfare, will chair the meeting of the SAARC health ministers. The visiting health ministers including Mr Firozuddin Feroz, Afghanistan; Mr Zahid Maleque, MP, Bangladesh; Mr. Lyonpo Tandin Wangchuk, Bhutan; Mr Ahmed Zuhoor, Maldives; Mr Khaga Raj Adhikari, Nepal; Ms Saira Afzal Tarar, Pakistan and Dr Rajitha Senaratne, Sri Lanka will participate in the meeting. Prior to the health ministers' meeting, the 7th Meeting of SAARC Expert Group on HIV/AIDS, 5th Meeting of the SAARC Technical Committee on Health and Population and the 5th Meeting of the SAARC Senior Officials (Health Secretaries) will be held during 6-7 April, 2015. The meetings are being organized in pursuance of decisions taken by the SAARC Summit of Heads of State or Governments held at Kathmandu in November, 2014. Approximately 50 delegates from all SAARC countries, including India, comprising officials and experts will participate in the technical and official level meetings. The 4th meeting of the SAARC Health Ministers was held at Maldives in April 2012. The meetings, to be chaired by India, will deliberate and provide guidance and a roadmap for strengthening collaboration among SAARC countries on a number of issues and challenges faced by these countries. Some of the prominent health issues to be discussed include prevention and control of communicable and non-communicable diseases, disease surveillance network, health infrastructure, human resources for health, immunization for vaccine preventable diseases, HIV/AIDS, mental health, improving access to medicines and anti-microbial resistance etc. The Health Ministers will also discuss for adoption the 'Delhi Declaration' affirming their commitment to work together in identified areas and further strengthen health collaboration with agreed roadmap and timelines. SAARC countries comprising Afghanistan, Bangladesh, Bhutan, India, Maldives, Nepal, Pakistan, and Sri Lanka account for nearly a quarter of the world population. These countries face similar health challenges and issues. The purpose of the meetings is to find out ways and means to synergize collective efforts, share strategies and implement identified best practices to provide better health and a better quality of life to the citizens of SAARC countries. These meetings also signal India's commitment to promote health cooperation in a more effective manner through the SAARC platform in keeping with the new policy of the Government of India to promote cooperation among the neighbouring countries. ]]> <![CDATA[Now approach pharmacists for free consultation]]> https://biospectrumindia.com/news/95/7356/now-approach-pharmacists-for-free-consultation.html https://biospectrumindia.com/news/95/7356/now-approach-pharmacists-for-free-consultation.html Mon, 06 Apr 2015 13:03:52 +0530 Confused about your prescription? Not to worry any more. Indian Medical Association (IMA) has started a free-of-charge consultation for patients, where they can consult a pharmacist at the IMA headquarters. This consultation will enable patients to get more information about the drugs they have been prescribed, and how they are responding to the drugs. Patients also will have the advantage of discussing any side effects and appropriately report it to their physicians. The pharmacist will be available for 8 hours a day. The project is said to go through further expansion for accommodating more patients in the future. ]]> <![CDATA[These three decades were worth it, says Dr Rao]]> https://biospectrumindia.com/features/95/3785/these-three-decades-were-worth-it-says-dr-rao.html https://biospectrumindia.com/features/95/3785/these-three-decades-were-worth-it-says-dr-rao.html Sat, 04 Apr 2015 10:12:00 +0530 The rotavirus vaccine was launched on March 09, 2015 by the Prime Minister, Mr Narendra Modi at Delhi. Developed by Hyderabad based Bharat Biotech, the oral rotavirus vaccine, ROTAVAC has been proved to be safe and effective in preventing rotavirus diarrhoea that anually kills nearly 80 thousand children under the age of 5 years. However, it is important to remember that such initiatives don't succeed untill there are people whose persuation skills keep the partnerships going. This initiative too had its heroes. Sharing his experinces is one of them. "Have been fortunate to be the part of vaccine development all through," says, Dr T S Rao, senior advisor, department of biotechnology who has been associated with the programme for three decades. "I still remember the day 25 years ago when both Dr M K Bhan and Dr Roger Glass walked into my room at DBT and we had a fruitful discussion for hours. This laid the foundation of matrix of long term efforts by hundreds of researchers that was based on pure passion to do something for nation. No doubt global partnerships later on added value and made the vaccine possible," Dr Rao told BioSpectrum feeling nostalgic about the experiences he had while spearheading the programme. Dr Rao credits all the joint work done by agencies in India and abroad with equal support from prominent scientists and bureaucrats. "This surely serves an example for the next stage and shows how 'Make in India' is possible with persuasion and continuation to ensure sustainability'" he summed up. ]]> <![CDATA[Indoco acquires Piramal's Clinical Research Division ]]> https://biospectrumindia.com/news/95/5770/indoco-acquires-piramals-clinical-research-division-.html https://biospectrumindia.com/news/95/5770/indoco-acquires-piramals-clinical-research-division-.html Fri, 03 Apr 2015 09:30:00 +0530 Indoco Remedies has signed a definitive agreement to acquire Piramal Clinical Research (PCL), a Hyderabad-based Clinical Research Division (CRO) of Piramal Enterprises, on a going concern basis. The CRO specializes in conducting bioequivalence and bioanalytical studies for generic products. This facility is spread across an area of 30,000 square feet and is equipped with a 98-bed facility, monitoring stations, phlebotomy stations, four-bed ICU, state-of-the-art analytical lab and capabilities of eCTD submission. "We are extremely happy to have the CRO division of Piramals as part of Indoco. This acquisition will expand the depth of our services to customers in India as well as across the globe and would reduce our dependability to outsource bio-equivalence studies. Apart from reducing cost and ensuring time-bound outcome of studies, the CRO would be a perfect fit to our existing R&D efforts, including facilitation of ANDA/Dossier filings", said Ms Aditi Kare Panandikar, managing director, Indoco Remedies. ]]> <![CDATA[Dr. Reddy's Labs in pact to acquire select portfolio of Belgian firm UCB]]> https://biospectrumindia.com/news/95/6289/dr-reddys-labs-in-pact-to-acquire-select-portfolio-of-belgian-firm-ucb.html https://biospectrumindia.com/news/95/6289/dr-reddys-labs-in-pact-to-acquire-select-portfolio-of-belgian-firm-ucb.html Thu, 02 Apr 2015 18:51:56 +0530 Hyderabad based pharma major Dr Reddy's Laboratories will acquire select portfolio of established brands of Belgian firm UCB in India, Nepal, Sri Lanka and Maldives for Rs 800 crore. In its filing to the BSE, the company said it has entered into a definitive agreement with UCB which also entails absorbing 350 employees engaged in the operations of India business. "The acquired business is being sold on a slump sale basis. The revenues of the acquired business is approximately Rs 150 crore for the calendar year 2014," it added. Commenting on the move, Dr Reddy's Laboratories Senior VP and India Business Head Alok Sonig said: "The acquired UCB portfolio shall accelerate Dr Reddy's presence in the high growth areas of dermatology, respiratory and pediatrics, with market leading brands like Atarax, Nootropil, Zyrtec, Xyzal, Xyzal M etc."UCB Chief Operating Officer Mark McDade said finding the right company for its established brands in India was crucial. "Dr Reddy's knowledge of the local market, combined with their ambitious plans and excellent reputation, convinced us that they were the right choice to drive this business forward," McDade added. The transaction is expected to be closed in the first quarter of the financial year 2015-2016, Dr Reddy's said. ]]> <![CDATA[Peter Bains is the new CEO of Syngene]]> https://biospectrumindia.com/news/95/6408/peter-bains-is-the-new-ceo-of-syngene.html https://biospectrumindia.com/news/95/6408/peter-bains-is-the-new-ceo-of-syngene.html Thu, 02 Apr 2015 12:09:00 +0530 Biotechnology major Biocon's custom research arm Syngene has appointed Mr Peter Bains as its Chief executive Officer (CEO). "Company's Subsidiary Syngene International (Syngene) has appointed Peter Bains, Director, as the CEO of Syngene," the company said in a filing to BSE. Mr Bains has more than two decades of experience in the global pharmaceutical space. There has been reports that Biocon would file a prospectus for listing Syngene soon. ]]> <![CDATA[FDA nod for Teva's asthma inhaler]]> https://biospectrumindia.com/news/95/6290/fda-nod-for-tevas-asthma-inhaler.html https://biospectrumindia.com/news/95/6290/fda-nod-for-tevas-asthma-inhaler.html Thu, 02 Apr 2015 12:08:36 +0530 Teva Pharmaceutical has announced that the US Food and Drug Administration (US FDA) has approved ProAir RespiClick (albuterol sulfate) inhalation powder. It is a breath-actuated, multi-dose, dry-powder, short-acting beta-agonist (SABA) inhaler for the treatment or prevention of bronchospasm in patients 12 years of age and older with reversible obstructive airway disease; and for the prevention of exercise-induced bronchospasm (EIB) in patients 12 years of age and older. It is expected to become commercially available to patients during the second quarter of 2015. "ProAir RespiClick is the first and only breath-actuated, dry-powder rescue inhaler to be approved by the FDA for the treatment of acute asthma symptoms," said Dr David I Bernstein of the University of Cincinnati College of Medicine, Division of Immunology, Allergy and Rheumatology. He added, "The approval of ProAir RespiClick is significant as it eliminates the need for hand-breath coordination during inhalation." The approval was based on a comprehensive clinical development program consisting of eight clinical trials designed to evaluate the safety and efficacy of ProAir RespiClick in adults and adolescents (12 years of age and older) with asthma and EIB. Clinical trial results has showed that ProAir RespiClick was both safe and effective with adverse events consistent with those seen with previous albuterol inhalers. The most common adverse events in greater than one percent of patients treated with ProAir RespiClick, compared to placebo, were back pain, body aches and pains, upset stomach, sinus headache, and urinary tract infection. "Teva is committed to optimizing respiratory therapies through the development of new delivery systems that address needs in the marketplace. The approval of ProAir RespiClick is an important step forward in the progress of Teva's respiratory portfolio as it represents the first U.S. approval of our core, breath-actuated, dry-powder delivery device platform which we believe will bring additional benefit to patients," said Mr Tushar Shah, senior vice-president, Teva Global Respiratory Research and Development. ]]> <![CDATA[Bayer expands collaborations to develop cardiac therapies]]> https://biospectrumindia.com/news/95/6219/bayer-expands-collaborations-to-develop-cardiac-therapies.html https://biospectrumindia.com/news/95/6219/bayer-expands-collaborations-to-develop-cardiac-therapies.html Thu, 02 Apr 2015 12:07:55 +0530 Bayer HealthCare (Bayer) has expanded its collaboration with the Broad Institute of Massachusetts Institute of Technology (MIT) and Harvard University to include cardiovascular genomics and drug discovery. The goal of this new part of the alliance is to leverage insights from human genetics to help create new cardiovascular therapies. "We are excited to broaden our collaboration with the Broad Institute to the area of cardiovascular genomics to discover genes and mutational changes underlying cardiovascular disorders in order to develop new therapies and diagnostic options for these diseases. We have been collaborating over the last two years and have developed a very constructive partnership during this time," said professor Andreas Busch, Head of Global Drug Discovery and member of the Executive Committee of Bayer HealthCare. Cardiovascular genomics is an emerging field of cardiology that uses genomic information to characterize disease risk and identify new therapeutic targets for drug discovery. "It is exciting to be expanding on our ongoing, successful partnership with Bayer in oncology," said professor Eric Lander, president and director of Broad Institute. He added, "We are looking forward to a fruitful collaboration combining Bayer's expertise in the cardiovascular therapeutic area with Broad's deep knowledge of genomics and biology." As part of this strategic alliance, Broad Institute and Bayer HealthCare will collaborate on genetic discovery, target validation, and drug discovery activities. Governance for this alliance will be comprised of a joint steering committee and joint research committee that will oversee research progress and direction. Financial terms of the agreement were not disclosed. ]]> <![CDATA[Field Trials of GM crops begin in Maharashtra]]> https://biospectrumindia.com/news/95/5817/field-trials-of-gm-crops-begin-in-maharashtra.html https://biospectrumindia.com/news/95/5817/field-trials-of-gm-crops-begin-in-maharashtra.html Wed, 01 Apr 2015 14:52:26 +0530 Five big seed companies including Monsanto, Mahyco and BASF have started field trials of genetically-modified (GM) crops in Maharashtra for crops such as rice, corn, chickpea and cotton, says a report by Business Line. Earlier this year the Maharashtra government had approved field trails of GM crops. Mahyco has started carrying out trials for GM rice in the Konkan region of coastal Maharashtra. Others such as Monsanto, BASF, Sungro Seeds and a large seed company based out of Andhra Pradesh have either started conducting field trials or are in the process of carrying out the same, the report stated. ]]> <![CDATA[Biocon to file for Syngene's IPO in two months: Reports]]> https://biospectrumindia.com/news/95/6703/biocon-to-file-for-syngenes-ipo-in-two-months-reports.html https://biospectrumindia.com/news/95/6703/biocon-to-file-for-syngenes-ipo-in-two-months-reports.html Wed, 01 Apr 2015 12:22:01 +0530 Biotechnology major Biocon could file a prospectus for a share listing for its research services business arm Syngene International within the next two months, says reports. Earlier this year, Biocon has said that it is looking to sell 10-15 percent stock from its majority stake in Syngene via an offer for sale. The company now owns an 85.54 percent stake in Syngene. Reportedly, The IPO for Syngene will be managed by Credit Suisse, Axis Bank and Jefferies. ]]> <![CDATA[Pall Corporation acquires BioSMB Technology from Tarpon Biosystems]]> https://biospectrumindia.com/news/95/5854/pall-corporation-acquires-biosmb-technology-from-tarpon-biosystems.html https://biospectrumindia.com/news/95/5854/pall-corporation-acquires-biosmb-technology-from-tarpon-biosystems.html Wed, 01 Apr 2015 11:46:33 +0530 Pall Corporation, a global leader in filtration, separation and purification, announces the acquisition of the BioSMB technology platform from Tarpon Biosystems. These chromatographic systems enable single-use, multicolumn chromatography for process development and are well placed for multiproduct and single-use facilities. BioSMB technology is fully scalable from process development to large scale GMP production. The disposable flow path features a proprietary integrated valve cassette and services up to 16 columns or devices. "We are pleased to add this cutting-edge technology to our growing portfolio of products and services. It extends our process intensification and continuous processing capabilities to support customers as they adopt continuous downstream processing," said Ken Frank, senior vice president at Pall Life Sciences. "The BioSMB technology incorporates disposable components to enable flexible, multiproduct biomanufacturing while reducing costs." Nelson K. Stacks, president of Tarpon Biosystems further stated, " With this acquisition the strength and reputation of Pall will enable an even wider adoption of the BioSMB platform." This latest addition expands Pall's portfolio in continuous processing technology at both the process development and GMP scales of operation, while complementing existing Allegro single-use products and systems. ]]> <![CDATA[Horizon to acquire Hyperion Therapeutics for $1.1 billion ]]> https://biospectrumindia.com/news/95/8376/horizon-to-acquire-hyperion-therapeutics-for-1-1-billion-.html https://biospectrumindia.com/news/95/8376/horizon-to-acquire-hyperion-therapeutics-for-1-1-billion-.html Wed, 01 Apr 2015 10:34:51 +0530 Horizon Pharma and Hyperion Therapeutics have announced that they have entered into a definitive agreement, in which Horizon will acquire all of the issued and outstanding shares of Hyperion's common stock for $46.00 per share in cash or approximately $1.1 billion on a fully diluted basis. The proposed transaction has been unanimously approved by both companies' board of directors. "The Hyperion acquisition will expand and diversify our product portfolio by adding two complementary orphan disease products, RAVICTI and BUPHENYL, and leverage as well as expand the existing infrastructure of our orphan disease business," said Mr Timothy P Walbert, chairman, president and chief executive officer, Horizon Pharma. "During the last two years, we have solidified our position in the orphan disease space and made significant progress in bringing life-changing medicines to people with urea cycle disorders," said Mr Donald J Santel, president and chief executive officer, Hyperion Therapeutics. He added, "I would like to thank my colleagues for their tireless commitment to advancing the clinical development and understanding of RAVICTI, BUPHENYL and urea cycle disorders. Horizon shares our commitment and I'm confident that the strength of its existing orphan business unit will continue to expand the reach of these important medicines to more patients impacted by these disorders." The acquisition is structured as an all cash tender offer for all the issued and outstanding shares of Hyperion common stock at a price of $46.00 per share followed by a merger in which each remaining untendered share of Hyperion common stock would be converted into the $46.00 per share cash consideration paid in the tender offer. Closing of the transaction is subject to customary conditions, including the tender of a majority of outstanding Hyperion shares and expiration or termination of the HSR waiting period. It is anticipated that the transaction will close in the second quarter of 2015. ]]> <![CDATA[UnitedHealth Group to buy Catamaran]]> https://biospectrumindia.com/news/95/6642/unitedhealth-group-to-buy-catamaran.html https://biospectrumindia.com/news/95/6642/unitedhealth-group-to-buy-catamaran.html Tue, 31 Mar 2015 14:50:00 +0530 OptumRx and Catamaran has announced that they have agreed to combine. OptumRx is UnitedHealth Group's free-standing pharmacy care services business. The agreement calls for the acquisition of Catamaran's outstanding common stock for $61.50 per share in cash. The transaction is expected to close during the fourth quarter of 2015, subject to Catamaran shareholders' approval, regulatory approvals and other customary closing conditions. The acquisition is expected to be accretive to UnitedHealth Group's net earnings in the area of $0.30 per share in 2016. UnitedHealth Group plans to finance the acquisition from existing cash resources and new debt. The company affirmed its $6.00 to $6.25 per share earnings outlook assuming the absorption of all merger costs, the ongoing commitment to advance its dividend policy as planned, and a continued but moderated level of share repurchase. Upon closing, Mr Mark Thierer, Catamaran's chairman and chief executive officer, will serve as chief executive officer of OptumRx and Mr Timothy Wicks, the current chief executive officer of OptumRx, will become president. This combination is expected to create a dynamic competitor in the PBM market by combining the strengths of Catamaran's industry-leading technology platform with the data and analytics capabilities of Optum. The combined company is expected to deliver an innovative and compelling consumer and payer services offering that will link demographic, lab, pharmaceutical, behavioral and medical treatment data to engage individuals to make better decisions as they seek the best, most effective care and improve compliance with pharmaceutical use and care protocols. Both companies have distinctive, rapidly growing specialty pharmacy services businesses. The combined organization will help customers manage the complex costs and outcomes as this portion of the pharmaceutical market expands from an estimated $100 billion in revenues in 2014 to potentially $400 billion annually by 2020. "We believe the combination of the two companies will create a unique offering in the industry unparalleled by current participants. Optum's longstanding business relationship with Catamaran as a technology partner means we operate on the same adjudication platform, simplifying integration and giving us confidence our combined organizations will quickly become an innovative force moving the pharmacy care services marketplace forward," said Mr Larry Renfro, chief executive officer, Optum. "Our Board of Directors carefully considered a variety of strategic options and unanimously concluded that this combination is clearly in the best interests of our shareholders. The creation of a differentiated, channel-agnostic delivery model will provide payers and individuals a broader portfolio of services and a deeper product offering while aggressively focusing on managing costs. Together, we believe we will have the talent, scale, technology resources and innovative spirit to build the most modern, effective and consumer-focused PBM in the history of the industry," said Mr Mark Thierer, chairman and chief executive officer of Catamaran. ]]> <![CDATA[Mr Bhartia resigns as Jubilant's MD]]> https://biospectrumindia.com/news/95/8360/mr-bhartia-resigns-as-jubilants-md.html https://biospectrumindia.com/news/95/8360/mr-bhartia-resigns-as-jubilants-md.html Tue, 31 Mar 2015 14:39:00 +0530 Jubilant Life Sciences informed BSE that consequent to appointment of Mr Shyam S Bhartia as chairman and managing director of Jubilant Pharma, Singapore, a wholly-owned subsidiary of Jubilant Life Sciences, he has resigned from the position of MD of the company effective from March 25, 2015. In view of the above, Mr Shyam S Bhartia shall be non-executive chairman and director of the company. ]]> <![CDATA[Novartis announces partnership with Aduro Biotech]]> https://biospectrumindia.com/news/95/6598/novartis-announces-partnership-with-aduro-biotech.html https://biospectrumindia.com/news/95/6598/novartis-announces-partnership-with-aduro-biotech.html Tue, 31 Mar 2015 11:28:12 +0530 Aduro Biotech has announced the establishment of a major collaboration with Novartis. The partnership is for the worldwide research, development and commercialization of novel immuno-oncology products derived from its cyclic dinucleotide (CDN) approach to target the STING (Stimulator of Interferon Genes) receptor, that, when activated, is known to initiate broad innate and adaptive tumor-specific immune responses. "We are extremely pleased to enter into this relationship with Novartis as their strong commitment and spirit of collaboration was evident early in our conversations," said Mr Stephen T Isaacs, chairman, president and chief executive officer of Aduro. He added, "We believe they are an ideal partner not only because of their stature as a premier healthcare company with a major focus in oncology, but also because they demonstrated a keen understanding and appreciation for our novel CDN approach, have synergistic innovation and scientific strengths and of course offer tremendous clinical and commercial expertise which we expect will broaden and accelerate the potential to bring products developed from this novel technology to patients in need." Under the terms of the agreement, Novartis will make an upfront payment of $200 million to Aduro and, if all development milestones are met, Aduro is eligible to receive up to an additional aggregate amount of $500 million. In addition, Novartis has made an initial 2.7 percent equity investment in Aduro for $25 million, with a commitment for another $25 million investment at a future date. Aduro will lead commercialization activities and will book sales in the United States for any products developed and commercialized pursuant to this collaboration, with Novartis leading commercialization activities in all other regions. The companies will share in profits, if any, in the United States, Japan and major European countries. Novartis will pay Aduro a mid-teens royalty for sales in the rest of the world. "We are delighted to collaborate with Aduro. We believe this target is among the most exciting in oncology today, the drug candidate to be of the highest quality, and the talent of our new colleagues from Aduro to be fantastic. We anticipate many clinical opportunities will be explored with the CDN approach, both directly and in combination with other agents," said Dr Mark C Fishman, president of the Novartis Institutes for BioMedical Research. Aduro maintains rights to its CDN technology in all other therapeutic areas, including infectious disease and autoimmunity, among others. ]]> <![CDATA[Strides launches Hep C drug in the country]]> https://biospectrumindia.com/news/95/5852/strides-launches-hep-c-drug-in-the-country.html https://biospectrumindia.com/news/95/5852/strides-launches-hep-c-drug-in-the-country.html Mon, 30 Mar 2015 14:29:35 +0530 In September 2014, Strides entered into a licensing agreement with Gilead Sciences, to bring hepatitis C cure to 91 developing countries. The product will be available to Indian patients shortly. Sofosbuvir is the first-in-class NS5B polymerase inhibitor to be launched in India for hepatitis C treatment and represents a paradigm shift in the existing hepatitis C management. The high potency, high barrier to resistance, pan genotypic activity, once-daily dosage, good safety profile and the limited drug-drug interactions of Sofosbuvir makes it a breakthrough drug in hepatitis C treatment. This drug in combination therapy has shown to have high cure rates of around 90 percent. Commenting on the announcement, Mr Mohan Kumar, CEO-Pharma, Strides Arcolab, stated "We are pleased to announce this launch in partnership with Gilead, which is a big leap in our commitment towards bringing critical healthcare at affordable cost." The launch in other markets is subject to approvals from the regulatory authorities in respective countries. Globally, it is estimated that 170-185 million people (about 3 percent of the world's population) are chronically infected with hepatitis C virus (HCV). In India alone, it is estimated that 12-18 million patients are infected with hepatitis C, which is several fold greater than those with HIV/AIDS. ]]> <![CDATA[Sepsis-specific treatment market to reach $354 mn by 2021]]> https://biospectrumindia.com/news/95/5322/sepsis-specific-treatment-market-to-reach-354-mn-by-2021.html https://biospectrumindia.com/news/95/5322/sepsis-specific-treatment-market-to-reach-354-mn-by-2021.html Mon, 30 Mar 2015 12:05:00 +0530 Following the first sepsis-specific product launch in 2016, the treatment market will expand at a compound annual growth rate (CAGR) of 69 percent to reach $354 million by 2021 across the six major markets (6MM) of the US, the UK, France, Germany, Italy, and Spain. This growth will be driven by the increased uptake of novel therapies, led by Asahi Kasei Pharma America's (AKP-A's) anti-coagulant ART-123 (recombinant human soluble thrombomodulin alpha), as the critical care community regains confidence in sepsis-specific products and more data is generated on their overall efficacy and safety. GlobalData, a research and consulting organization, projects that the sepsis-specific treatment space will be valued at $25.7 million across the 6MM in 2016, supported by the expected regulatory approval of ART-123, with the US accounting for almost 80 percent of sales, or $20.3 million. Dr Marc C Hansel, GlobalData's analyst covering infectious diseases, says that AKP-A's ART-123, which will likely be indicated for the treatment of severe sepsis and septic shock patients with coagulopathy and sepsis-induced acute lung injury (ALI)/acute respiratory distress syndrome (ARDS), will dominate the market. He further explained: "ART-123 will be the only regulatory-approved sepsis-specific drug available until 2019 and will command a premium price due to its first-in-class status. The earlier-stage pipeline products will garner a little more than 30 percent of market share by 2021, due to their later market entry. "However, primary and secondary research indicates that early-stage approaches, particularly immunomodulatory agents, are most promising because their major mechanisms of action are directed at the irregular immune response that causes the sepsis syndrome." Despite the projected growth, the analyst warns that developers looking to enter the sepsis-specific therapeutics space must be aware of lingering skepticism towards these products, which emerged after the worldwide voluntary recall of Eli Lilly's anti-coagulant Xigris (drotrecogin alfa [activated]) in 2011, the last product to be approved and marketed as a sepsis treatment. "This guarded climate, alongside inadequate sepsis awareness and a variety of obstacles to effective clinical trials, such as proper patient identification, endpoint selection, and development strategy, will likely serve as a formidable barrier to the approval and uptake of novel pipeline therapeutics throughout the forecast period," Dr Hansel concludes. ]]> <![CDATA[SRL Diagnostics to expand its business]]> https://biospectrumindia.com/news/95/7116/srl-diagnostics-to-expand-its-business.html https://biospectrumindia.com/news/95/7116/srl-diagnostics-to-expand-its-business.html Mon, 30 Mar 2015 11:34:08 +0530 SRL Diagnostics is planning to open labs and collection centres in Kenya, Tanzania, Mozambique and Uganda. "We have 260 laboratories across India, Nepal, Sri Lanka and Dubai. The company sees significant opportunity in Africa. Now we plan to expand our network in Kenya, Tanzania, Mozambique and Uganda," said Mr Sanjeev Vashishta, CEO, SRL Diagnostics, in a statement. The company will tie up with a local partner to set up reference laboratories. ]]> <![CDATA[Fortis sells its Singapore hospital]]> https://biospectrumindia.com/news/95/6530/fortis-sells-its-singapore-hospital.html https://biospectrumindia.com/news/95/6530/fortis-sells-its-singapore-hospital.html Mon, 30 Mar 2015 11:33:33 +0530 Fortis Healthcare has sold its Singapore Hospital to Concord Medical Services for $40 million (Rs 251 crore) in line with the strategy to focus on the domestic market. "The Board of Fortis Healthcare International, a step down subsidiary of Fortis Healthcare based out of Singapore, has decided to disinvest 100 percent shareholding in Fortis Healthcare Singapore which holds and operates Fortis Surgical Hospital to Concord Medical Services for a consideration of $40 million (Singapore Dollar (SGD) 55 million or Rs 251 crore)," the company said in a BSE filing. "Our decision to divest is in tune with our stated strategy to intensify our focus on our hospitals and diagnostics business in India," said Mr Malvinder Singh, executive chairman and Mr Shivinder Singh, executive vice-chairman, Fortis Healthcare, in a statement. According to the filing, the deal is expected to be completed on or around April 6. JP Morgan and Religare Capital Markets acted as financial advisors to Fortis for the transaction. ]]> <![CDATA[Wockhardt honored at the Golden Globe Tigers Summit - Awards 2015 ]]> https://biospectrumindia.com/news/95/6393/wockhardt-honored-at-the-golden-globe-tigers-summit-awards-2015-.html https://biospectrumindia.com/news/95/6393/wockhardt-honored-at-the-golden-globe-tigers-summit-awards-2015-.html Sat, 28 Mar 2015 11:34:00 +0530 The Hospital recently had also bagged the prestigious HR awards at the Global HR Excellence Summit 2015, held in India. Golden Globe Tigers Awards recognizes achievers, super achievers and future business leaders. The HR Leadership Awards recognizes the achievements made by selected high profile corporate business leaders in Asia. ]]> <![CDATA[Dr Venema named new CSO of USP]]> https://biospectrumindia.com/news/95/6463/dr-venema-named-new-cso-of-usp.html https://biospectrumindia.com/news/95/6463/dr-venema-named-new-cso-of-usp.html Fri, 27 Mar 2015 13:56:28 +0530 The United States Pharmacopeial Convention (USP) announced that Dr Jaap Venema will become the chief science officer (CSO) on April 15 and chair of USP's standards-setting body, the council of experts, at the beginning of USP's next five-year cycle on July 1, 2015. "I'm thrilled to be joining USP on the eve of the 2015 convention and being part of the next USP cycle, leading to the USP bicentennial in 2020. USP's mission to improve global health is one that aligns with my own values and aspirations and I'm looking forward to my first day at USP," said Dr Venema. Retiring CSO Dr V Srini Srinivasan, served USP in many capacities over a distinguished career of more than 30 years. The USP is a global health organization that improves lives through public standards and related programs that help ensure the quality, safety, and benefit of medicines and foods. ]]> <![CDATA[Countries preparing for Polio End Game Strategy: WHO]]> https://biospectrumindia.com/news/95/6239/countries-preparing-for-polio-end-game-strategy-who.html https://biospectrumindia.com/news/95/6239/countries-preparing-for-polio-end-game-strategy-who.html Fri, 27 Mar 2015 13:55:43 +0530 WHO congratulated Member States for keeping polio at bay, despite the continued threat of poliovirus importation from polio-infected countries outside of the region. On May 5, 2014. the region was declared a global public health emergency of international concern by the director-general, WHO following its spread beyond the endemic Afghanistan, Nigeria, and Pakistan as these infected countries continue to pose a risk to the polio-free status of WHO South-East Asia region. Countries like Bangladesh, Bhutan, India, Myanmar and Nepal in the region are taking additional measures such as cross-border vaccination, while India has made polio vaccination, mandatory for travellers to and from the infected countries. Nepal and Maldives have introduced inactivated polio vaccine (IPV) in their immunization schedule and other countries are expected to follow suit. "Countries of the region are preparing for the Polio End Game Strategy, to introduce a dose of injectable IPV in childhood immunization schedules ahead of the proposed globally synchronized, phased and sequential withdrawal of oral polio vaccines," said Dr Poonam Khetrapal Singh, regional director, WHO Southeast Asia. ]]> <![CDATA[FDA nod for Sanofi's Quadracel vaccine]]> https://biospectrumindia.com/news/95/6323/fda-nod-for-sanofis-quadracel-vaccine.html https://biospectrumindia.com/news/95/6323/fda-nod-for-sanofis-quadracel-vaccine.html Thu, 26 Mar 2015 14:35:10 +0530 Sanofi Pasteur has announced that the US Food and Drug Administration (US FDA) has approved the use of Quadracel (Diphtheria and Tetanus Toxoids and Acellular Pertussis Absorbed and Inactivated Poliovirus; DTaP-IPV) vaccine for active immunization against diphtheria, tetanus, pertussis and poliomyelitis in children four through six years of age. "The FDA approval of Quadracel vaccine provides health care providers with a new combination vaccine, potentially reducing the number of vaccine injections children aged four through six would need. Our goal is to help remove barriers to timely immunization and we think this combination vaccine could help ensure children are getting vaccinated in line with current recommendations," said Dr David P Greenberg, vice-president, US Scientific and Medical Affairs, Sanofi Pasteur. This FDA approval is based on the data from a pivotal multicenter, randomized, controlled, Phase III study designed to compare the safety and immunogenicity of Quadracel vaccine (DTaP-IPV) with DAPTACEL (DTaP) and IPOL (IPV) vaccines. This is in children four through six years of age who were previously vaccinated with DAPTACEL and/or Pentacel (DTaP-IPV/Hib) vaccines. Results show Quadracel vaccine has similar safety and immunogenicity profiles as compared to those of separately administered DAPTACEL and IPOL vaccines. ]]> <![CDATA[L'OrÃ©al, inStem to collaborate on skin biology research]]> https://biospectrumindia.com/news/95/7274/loral-instem-to-collaborate-on-skin-biology-research.html https://biospectrumindia.com/news/95/7274/loral-instem-to-collaborate-on-skin-biology-research.html Thu, 26 Mar 2015 14:16:51 +0530 The research agreement was signed by Prof. Satyajit Mayor, director, inStem and Mr Francois Pradier, director, research and innovation, L'OrÃ©al India. The collaborative research program between L'OrÃ©al and the Centre for Inflammation and Tissue Homeostasis (CITH) at inStem will focus on exploration of biological mechanisms that influence skin-aging. On the occasion of this collaboration, Mr Francois Pradier, director of L'OrÃ©al Research & Innovation (R&I) in India said, "...This partnership is a step forward to achieving our goal of generating knowledge of Indian skin and hair...." A major objective of this collaboration would be to study the molecular mechanisms and signaling pathways involved in the cell biology of skin homeostasis. L'OrÃ©al will share its active ingredients for evaluation and validation of these concepts. "... Our emphasis on understanding basic biological principles synergizes well with the translational focus of L'OrÃ©al and together we expect this collaboration will advance our understanding of skin biology, and may also lead to new ideas for skin and hair care. This partnership will provide a unique access to active ingredients of L'OrÃ©al, enabling us to modulate different processes involved in skin homeostasis. Beyond scientific interest this collaboration provides our graduate students and postdoctoral fellows the opportunity to work with industry where they are encouraged to view how their work can affect people outside of their narrow area of research," commented Dr Colin Jamora, coordinator, CITH, inStem. ]]> <![CDATA[First-in-class drug development remains low ]]> https://biospectrumindia.com/features/95/5719/first-in-class-drug-development-remains-low-.html https://biospectrumindia.com/features/95/5719/first-in-class-drug-development-remains-low-.html Thu, 26 Mar 2015 14:12:18 +0530 According to the company's latest report, financial incentives have been lacking over the past few decades. Healthcare organizations, such as the UK's National Health Service, remain unwilling to prescribe newly-diagnosed, premium products, due to their inferior cost effectiveness to generics and a desire to limit their use to prevent growth in antibiotic resistance. Furthermore, antibiotic development is notoriously difficult, with high failure rates. This is reflected in the fact that only 12 new drugs have been approved by the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) since 2000, with just four of these products boasting first-in-class status. Ms Katie Noon, analyst, GBI Research, said, "In response to growing concerns over the lack of new antibiotics, the FDA passed the 2011 Generating Antibiotics Incentives Now Act to help boost development in the field. This was followed by Europe's similarly-aimed COMBACTE project initiated in January 2013." "These projects aim to improve antibiotic development through incentives, such as priority FDA reviews, an additional five years of market exclusivity, changes to clinical trial regulations, and the establishment of cross-country clinical trial networks to improve patient recruitment, according to Forsyth." Despite these changes, GBI Research states that returns on the investment needed to develop antibiotics remain poor. One approach, proposed by the World Health Organization (WHO), is to uncouple a drug's sales cost from its developmental costs. Others have proposed increasing public funding, or introducing purchaser contracts to ensure the sale of a novel antibiotic for an appropriate timeframe. Ms Noon believes that if approved incentives are successful in driving antibiotic development, there would be hopes to see a rising number of first-in-class targets over the next decade. However, as the analyst concluded: "The high failure risk associated with antibiotic development means that current and future candidates would need to demonstrate overwhelmingly positive results in discovery or preclinical trials, or their development is unlikely to be pursued beyond these stages." ]]> <![CDATA[Another Hepatitis C drug in the market]]> https://biospectrumindia.com/news/95/6137/another-hepatitis-c-drug-in-the-market.html https://biospectrumindia.com/news/95/6137/another-hepatitis-c-drug-in-the-market.html Thu, 26 Mar 2015 12:48:51 +0530 Cipla has announced the launch of generic drug, Sofosbuvir for treating chronic Hepatitis C. It is available under the brand name 'Hepcvir'. "Following the non-exclusive licensing agreement signed with Gilead Sciences in September last year to manufacture and market chronic Hepatitis C medicines, Cipla is now all set to make the drug Sofosbuvir available to Indian patients in a week's time," the company said in a statement. The company further said that the availability of product in other markets is subject to approvals from the regulatory authorities in the respective countries. "Cipla has always brought accessible and affordable medicines to fight against diseases like AIDS and Hepatitis B; hence, it has made it a priority to bring Hepcvir to patients in India as well as the other developing nations," said Mr Subhanu Saxena, MD and global CEO, Cipla. ]]> <![CDATA[Sun Pharma completes acquisition of Ranbaxy]]> https://biospectrumindia.com/news/95/6767/sun-pharma-completes-acquisition-of-ranbaxy.html https://biospectrumindia.com/news/95/6767/sun-pharma-completes-acquisition-of-ranbaxy.html Thu, 26 Mar 2015 12:15:32 +0530 Sun Pharmaceutical begins the integration of Ranbaxy's business following the successful closure of its merger. The merger has fortified Sun Pharma's position as the world's fifth largest specialty generic pharmaceutical company and the top ranking Indian Pharma company with significant lead in market share. The combined entity's manufacturing footprint covers five continents with products sold in over 150 nations with a stronger presence in US, India, Asia, Europe, South Africa, CIS and Russia and Latin America. Post-merger, Daiichi Sankyo becomes the second largest shareholder in Sun Pharma and both the companies will work together to leverage this relationship for global business growth. The combination allows Sun Pharma to Significantly expand its R&D capabilities and global presence, especially across emerging markets, Enhance product portfolio and market depth in India, US as well as Rest of the World markets and Improve strategic flexibility, ability to pursue partnerships and strengthen M&A bandwidth. Following the closure of this transaction, Ranbaxy will be delisted from the Indian Stock Exchanges. Ranbaxy shareholders will receive 0.8 share of Sun Pharma for each share of Ranbaxy. Mr Israel Makov, chairman, Sun Pharma said, "The combined entity will capitalize on the expanded global footprint and enhance our dominance as a world leader in the specialty generics landscape. Sun remains committed to uncompromised product quality, 100 percent compliance and promotes innovation to create the most dynamic global specialty generics pharmaceutical company. We believe that our shareholders, customers and employees will share our excitement in the potential of this combination and thank them for their continued support." Commenting on the combined entity's priorities, Mr Dilip Shanghvi, managing director, Sun Pharma further added,"It is an important milestone in the history of Sun Pharma as we enter into a new phase of growth. We will continue to focus on gaining trust of the Regulators globally while continuing to develop products based on patient needs and leverage them to become brand leaders globally." ]]> <![CDATA[IHH healthcare buys 51% stake in Continental Hospitals]]> https://biospectrumindia.com/news/95/6094/ihh-healthcare-buys-51-stake-in-continental-hospitals.html https://biospectrumindia.com/news/95/6094/ihh-healthcare-buys-51-stake-in-continental-hospitals.html Thu, 26 Mar 2015 09:34:00 +0530 According to a stock market disclosure, Malaysia's largest hospital operator IHH healthcare has acquired 51 percent stake in Hyderabad-based Continental Hospitals for about $45.4 million. This marks a rare move by an international healthcare provider to buy a majority stake in an Indian hospital. Continental Hospitals is a 750-bed multi-specialty hospital located in Hyderabad. The deal was routed through a Singapore-based indirect subsidiary of IHH. "Continental's carefully chosen team of experts, who are internationally-recognized healthcare professionals from over 30 specialties, is dedicated to providing top-notch patient care using world-class medical equipment and superior technology," IHH said in a statement. IHH also has two joint ventures with Apollo Gleneagles Hospital in Kolkata and Apollo Gleneagles PET-CT Centre in Hyderabad. IHH's global healthcare network operates over 4,900 licensed beds in 30 hospitals, as well as 60 medical centers, clinics and ancillary healthcare businesses across eight countries. ]]> <![CDATA[Intas enters the European market]]> https://biospectrumindia.com/news/95/6028/intas-enters-the-european-market.html https://biospectrumindia.com/news/95/6028/intas-enters-the-european-market.html Wed, 25 Mar 2015 12:12:26 +0530 Intas Pharmaceuticals has announced that it has acquired Spanish drug maker Combino Pharm's hospital business in Spain and Portugal for an undisclosed amount. The acquisition was made by Accord Healthcare, Intas' subsidiary based out of the UK and Spain. Reportedly, the acquisition will help the company become the second-largest hospital business player in Spain. "We would like to inform you the Combino Pharm has transferred their hospital division to Accord Healthcare," said the company in a statement. ]]> <![CDATA[World TB Day: Awareness program held at AIIMS Delhi]]> https://biospectrumindia.com/news/95/5969/world-tb-day-awareness-program-held-at-aiims-delhi.html https://biospectrumindia.com/news/95/5969/world-tb-day-awareness-program-held-at-aiims-delhi.html Tue, 24 Mar 2015 15:38:24 +0530 Speaking on the occasion, Prof. Sarman Singh, Faculty-in-charge, Microbiology, Department of Laboratory Medicine, AIIMS said, "Early identification and treatment of TB is the key to preventing further spread TB. Our aim is to reach out to every TB patient and urge them to go to the nearby government health centres if they show symptoms of tuberculosis that is cough and fever for more than 2 weeks." In addition, a day-long symposium was organized in AIIMS auditorium attended by experts including Dr KS Sachdeva, CTD, RNTCP, Dr Amita Jain, KGMC Lucknow, Dr GC Khilnani, AIIMS, Dr AB Dey, AIIMS and Dr PN Dogra, AIIMS. The Chief-Guest on the occasion was Dr VM Katoch, former secretary and DG-ICMR, DHR, Government of India. Experts at the symposium opined that India should generate its own data reading efficacy of various diagnostic tests. Special attention need to be provided to high risk groups such as babies and young children, older adults, people who have other disease that weaken the immune system, and those who were infected with the TB bacteria in the past. Mr Varun Khanna, managing director, BD India said, "Left untreated, each person with active TB may infect on average between 10 and 15 people every year. In 2013, the World Health Organization identified 3 million missing TB cases globally of which 1 million were in India. BD is committed to responding to the needs of those affected by TB and this year we are pleased to drive this awareness campaign for the second consecutive year at AIIMS campus. It is an effort to help address the diagnosis and treatment to our missing million. In our efforts to address such unmet healthcare needs in India, we are strengthening the healthcare systems heavily burdened by TB." ]]> <![CDATA[Mission Indradhanush: India steps up immunization efforts]]> https://biospectrumindia.com/news/95/4698/mission-indradhanush-india-steps-up-immunization-efforts.html https://biospectrumindia.com/news/95/4698/mission-indradhanush-india-steps-up-immunization-efforts.html Tue, 24 Mar 2015 13:49:08 +0530 The health minister Mr JP Nadda sought the cooperation and support of various stakeholders including civil society, development partners, states, political leaders, and the media for creating awareness regarding the importance of fully immunizing every child against all vaccine preventable diseases in the country. He was speaking at the launch of the multi-media campaign for Mission Indradhanush. Mission Indradhanush, depicting the seven colors of the rainbow, aims to cover all those children by 2020 who are either unvaccinated or are partially vaccinated against seven vaccine preventable diseases which include diphtheria, whooping cough, tetanus, polio, tuberculosis, measles, and hepatitis B. The Prime Minister, in a message sent for the media launch of the Mission Indradhanush, expressed happiness that the ministry of health and family welfare has launched the nationwide initiative to protect children from seven life threatening diseases that can be easily prevented by vaccines. He congratulated the Ministry for taking up this initiative and extended his best wishes for its success. He also appealed to the parents and guardians of all children to ensure that their children are fully vaccinated. Speaking at the occasion, the Health Minister reiterated the importance of immunization for all children. "A nation cannot be healthy when its children, who are its most valuable assets, are not healthy. This can happen when we immunize all children against all vaccine preventable diseases." he said. Elaborating on Mission Indradhanush which seeks to achieve this goal, the Health Minister informed that between 2009-2013 immunisation coverage has increased from 61 percent to 65 percent, indicating only 1 percent increase in coverage every year. To accelerate the process of immunization by covering 5 percent and more children every year, the Mission Mode has been adopted to achieve target of full coverage by 2020. The Minister stated that 201 high-focus districts will be taken up for implementation in the first phase. Of these, 82 districts are in just four states of UP, Bihar, Madhya Pradesh and Rajasthan and nearly 25 percent of the unvaccinated or partially vaccinated children of India are in these 82 districts of four states. Moreover, 297 will be targeted for the second phase. The minister stated that the micro plans developed to make the Mission successful will draw on the lessons learned from the Polio eradication program towards systems strengthening, vaccine cold chain management, regular surveillance and monitoring of the plans to reach each and every left out and uncovered child. Highlighting the critical importance of a targeted and effective IEC campaign, Mr Nadda stated that studies have revealed that children are left uncovered by the routine immunisation programme either because the parents and guardians are unaware of the drive, or there is some element of apprehension or fear due to vaccination. Both these can be effectively addressed through an awareness campaign which underlines the critical importance of vaccination, and removes any apprehension harboured by the parent or the guardian. He appealed to them to participate in the Mission Indradhanush to ensure that no child is left uncovered during the rounds that will commence soon. Terming media as a powerful instrument that can bring about an everlasting change in the society through changing mindsets and generating awareness about various issues, the Health Minister stated that he looks at them to guide the Ministry at various stages in its endeavor to successfully implement the ambitious Mission. Health Secretary, Mr Bhanu Pratap Sharma underscored the challenges that face the effective implementation of the Mission given the scale of the country and the difficulties in reaching children living in rural and remote areas, riverine mining units, far flung and remote hamlets etc. He stated that the team of AHSAs and ANMs are committed in their endeavor to make the Mission a success. The Ministry has particularly paid attention to systems strengthening and capacity building of the frontline workers in this Mission Mode. Also present at the function were Mr Louis-Georges Arsenault, UNICEF representative, India; Dr Nata Menabde, WHO representative, India; Mr Deepak Kapur, chairperson, Rotary India National PolioPlus Committee; Prof. Laxminarayan Ramanan, vice president, PHFI -ITSU; Dr (Prof) Jagdish Prasad, DGHS, Health Ministry and other senior officers of the Health Ministry, representatives from several states, development partners and media. ]]> <![CDATA[Aeglea raises $44 mn led by Eli Lilly, Novartis]]> https://biospectrumindia.com/news/95/5841/aeglea-raises-44-mn-led-by-eli-lilly-novartis.html https://biospectrumindia.com/news/95/5841/aeglea-raises-44-mn-led-by-eli-lilly-novartis.html Tue, 24 Mar 2015 13:01:22 +0530 Aeglea Biotherapeutics, a biopharmaceutical company developing novel treatments for inborn errors of metabolism and therapies targeting tumor metabolism, announced the closing of a $44 million Series B financing. The financing was led by existing investors Lilly Ventures and Novartis Venture Fund. The proceeds from the financing will be used to support the continued development of Aeglea's innovative pipeline of engineered human enzymes that target diseases at the extremes of abnormal metabolism. "New treatments for individuals with inborn errors of metabolism or hematologic and solid malignancies are urgently needed, and this financing enables us to advance our lead molecule into the clinical setting as well as pursue the preclinical development of our pipeline products to address significant unmet medical needs," said Dr David G Lowe, co-founder, president and CEO, Aeglea. ]]> <![CDATA[Sanofi, Evotec sign deal to bolster biomedical research]]> https://biospectrumindia.com/news/95/5670/sanofi-evotec-sign-deal-to-bolster-biomedical-research.html https://biospectrumindia.com/news/95/5670/sanofi-evotec-sign-deal-to-bolster-biomedical-research.html Mon, 23 Mar 2015 13:00:18 +0530 The agreement is expected to be effective as of March 31. This strategic collaboration aims to sustain a high level of scientific and technological activities, maintain jobs and attract new talent and projects to the site. "I commend and thank our on-site team members for their hard work and commitment to this project, which is a major opportunity for the Toulouse site. I would also like to express my appreciation to all the stakeholders - elected officials, authorities, associations, members of the scientific community - whose invaluable support has made this project possible," said Mr Elias Zerhouni, Sanofi global R&D president. In particular, the agreement includes the divestiture to Evotec of the site's Research and Technological platform activities which match Evotec's areas of expertise as well as the continuation of these activities and the corresponding transfer of the employees currently involved in these activities. For Sanofi, the strategic collaboration also involves a financial commitment of â‚¬ 250 million over a five-year period for the implementation of a multi-year research program including, among other projects, the creation of a support fund dedicated to developing scientific collaboration with academic partners in France. ]]> <![CDATA[Stempeutics receives ATMP classification from EMA]]> https://biospectrumindia.com/news/95/5647/stempeutics-receives-atmp-classification-from-ema.html https://biospectrumindia.com/news/95/5647/stempeutics-receives-atmp-classification-from-ema.html Mon, 23 Mar 2015 12:54:48 +0530 Stempeutics Research, a group company of Manipal Education and Medical Group and a JV with Cipla Group, announced that the European Medicines Agency (EMA)has granted Advanced Therapy Medicinal Product classification for its novel stem cell drug 'Stempeucel', which will be used for the treatment of Thromboangiitis Obliterans (TAO). The Advanced Therapy Medicinal Product (ATMP) classification, approved by the committee for Advanced Therapies (CAT) of the European Medicines Agency, will allow Stempeutics to commercialize the product 'Stempeucel' across the European Union region. Commenting on the ATMP classification, Mr B N Manohar, CEO, Stempeutics said, "We are happy to receive ATMP status from the EMA. We view this as an important milestone to further develop our novel stem cell biological drug Stempeucel in the EU for treating Thromboangiitis Obliterans indication. Additionally, we interpret this as a favourable indication for how the European regulators view our therapy." Thromboangiitis Obliterans is a recurring progressive inflammation and thrombosis(clotting) of small and medium arteries and veins of the feet. It is strongly associated with use of tobacco products primarily from smoking, but also from smokeless tobacco. Stempeucel drug is expected to address the root cause of the disease throughanti-inflammatory and immune-modulatory mechanisms. It is expected to induce angiogenesis through release of vascular endothelial growth factors, epithelial growth factors, angiopoietin and improve the perfusion and help the repair and regeneration of the ischemic muscle tissue. Dr Jeff Karp, associate professor of Medicine, Harvard Medical School, who serves as Scientific Advisor to Stempeutics said, "I see Stempeutics as a global regenerative medicine company that could make a significant difference to disease treatment. Stempeutics has an impressive combination of exciting technologies and it has been wonderful to work with the team as they achieve critical milestones and advance their products to patients." The aim of the ATMP classification is to regulate cell and gene therapy and tissueengineered medicinal products, providing a benchmark for a level of quality compliance for pharmaceutical practices. The regulation provides guidelines to research development companies for following a standardized process in order to obtain approval in EU countries. The regulation also offers incentives to companies involved in developing ATMPsin the European Union, including fee reductions for scientific advice, scientificrecommendations on ATMP classification and evaluation and certification of quality and non-clinical data. ]]> <![CDATA[Govt launches equity fund for biotech entreprenuers]]> https://biospectrumindia.com/news/95/6583/govt-launches-equity-fund-for-biotech-entreprenuers.html https://biospectrumindia.com/news/95/6583/govt-launches-equity-fund-for-biotech-entreprenuers.html Mon, 23 Mar 2015 09:59:04 +0530 "BIRAC AcE" Fund is aimed at addressing the pressing needs of accelerating the growth of entrepreneurs, in the field of biotechnology. This fund will be operated by Biotechnology Industry Research Assistance Council (BIRAC) a Public Sector Undertaking under the Department of Biotechnology (DBT), with Incubators and Business Accelerators, as its partners. Speaking on the occasion of the third foundation day of BIRAC, the minister of state for science and technology, Mr YS Chowdary made the announcement and expressed hope that this major step taken by the Government would dramatically change the landscape of the Biotech startup ecosystem in the country. He mentioned that this is important and a major decision wherein the Government will be a partner in Equity Funding for Start Up's. The Minster also mentioning several budgetary provisions that are aimed at encouraging self employment and start ups said that a help-desk is proposed to be set up in his ministry for people wanting to know of these schemes. Earlier the minister for science and technology, Dr Harsh Vardhan who was abroad for attending the Science & Technology Minister's Conference of Brazil, Russia, India, China and South Africa (BRICS) in Brazil gave his message to the Conference. He said recent success stories in the field of biotechnology in India and also increased budgetary allocations by the Government for innovation in the form of ATAL Innovation Fund etc. makes him believe that the target set for the biotechnology sector will be achieved. Mr Chowdary also inaugurated a two day Panel discussions, to make biotechnology one of the drivers of the 'Make in India' programme. The theme for the foundation day is "Accelerating Innovations: India the Next Biotech Global Hub". Several eminent speakers from the field of Biotechnology including senior bureaucrats from DIPP, ICMR, Department of Pharmaceuticals and Senior Industry Leaders such as Dr Kiran Mazumdar-Shaw, CMD, Biocon will participate in panel discussions. Among themes for discussion are topics like - India the next Global Biotech Hub: The status of our readiness?, India a Bio-manufacturing Hub: Bridging the Paradigm for Quality and Affordability, Leveraging Partnerships to Make in India : Collaborating with national and international partners for enhanced competency. A plenary talk on- 'Make in India': a Perspective on the Biotech Sector: the opportunities, the enablers and the challenges, is also scheduled to be delivered by the chairman and managing director, Biocon Dr Kiran Mazumdar Shaw. Over 250 Scientists, Entrepreneurs & Industry Experts, and Policy Makers will participate. The focus of the discussion would be on India's readiness to meet the challenges of "Make in India" in the Biotech sector. BIRAC was established under the aegis of the Department of Biotechnology, Ministry of Science & Technology, Government of India as a Public Sector Undertaking three years ago and is mandated to foster and promote innovation research in biotech industries specially start-ups and SMEs. Today, BIRAC has more than 100 Young Entrepreneurs, nearly 250 companies and start-ups and 15 incubators supported as an important part of the Innovation ecosystem of the country. ]]> <![CDATA[Anti-microbial resistance on govt's radar]]> https://biospectrumindia.com/news/95/5109/anti-microbial-resistance-on-govts-radar.html https://biospectrumindia.com/news/95/5109/anti-microbial-resistance-on-govts-radar.html Mon, 23 Mar 2015 09:48:15 +0530 Information regarding consumption of antibiotics in India is not being centrally collected. However, irrational uses of antibiotics including irregular, incomplete and inadequate treatments along with overuse of antibiotics are known drivers of drug resistance. The health minister, Mr JP Nadda stated this in a written reply in the Lok Sabha on March 20, 2015. The Drugs and Cosmetic Rule, 1945 were amended in 2013 to incorporate a new Schedule H1 under the said rules containing 46 drugs which include III and IV generation antibiotics, anti TB drugs and certain habit forming drugs for having strict control over the sale of these drugs. The Drugs falling under Schedule H1 are required to be sold in the country with the following conditions:- The supply of a drug specified in Schedule H1 shall be recorded in a separate register at the time of the supply giving the name and address of the prescriber, the name of the patient, the name of the drug and the quantity supplied and such records shall be maintained for three years and be open for inspection. The drug specified in Schedule H1 shall be labeled with the symbol Rx which shall be in red and conspicuously displayed on the left top corner of the label, and shall also be labeled with the following words in a box with a red border. Further, the Government of India has formulated a National policy for containment of antimicrobial resistance in 2011. A National Program for Containment of AMR has also been initiated in 12th Five Year Plan with the following objectives: To establish a laboratory based surveillance system by strengthening laboratories for AMR in the country and to generate quality data on antimicrobial resistance for pathogens of public health importance. To generate awareness among healthcare providers and in the community regarding rational use of antibiotics and to strengthen infection control guidelines and practices and promote rational use of antibiotics. ]]> <![CDATA[India accounts for 26% of TB cases in Southeast Asia]]> https://biospectrumindia.com/news/95/5636/india-accounts-for-26-of-tb-cases-in-southeast-asia.html https://biospectrumindia.com/news/95/5636/india-accounts-for-26-of-tb-cases-in-southeast-asia.html Mon, 23 Mar 2015 09:29:19 +0530 Tuberculosis affects nearly three million people in WHO's Southeast Asia Region every year. Of them, nearly one million go undetected / untreated. On World TB Day, WHO calls upon countries to aggressively scale up efforts to find, treat and cure these missing cases. "The region is making progress in the fight against TB but to win the battle we need to improve access to treatment and care for the disease. We need to address the social, economic and behavioral factors to reach each of those million missing TB affected persons," said Dr Poonam Khetrapal Singh, WHO regional director for Southeast Asia. WHO Southeast Asia Region has made gains against TB and is on track to achieve the global target of 50 percent reduction in TB death rates by 2015 as compared with 1990. The access to TB care has expanded substantially since the year 2000 with 88 percent treatment success rates. Almost 22 million TB patients have been treated in the past 10 years. However, the scale of TB in the region is alarming as it still accounts for 38 percent of the global TB cases. India alone accounts for 26 percent. An estimated 450000 people died of TB in the Region in 2013, with most deaths reported from Bangladesh, India, Indonesia, Myanmar and Thailand. Concerted action is needed to reach the missing cases. These cases are being missed mainly due to underreporting from the public and private sectors, social stigma and lack of access to services. TB services - screening, testing and care - need to be expanded with a primary health care approach to ensure equitable access. Public-private collaborations should be enhanced for increased case notification. Community-based TB services that have demonstrated cost-effectiveness, higher utilization and better outcomes, should be further strengthened. People with TB still suffer discrimination, stigma, rejection and social isolation. Social support needs to be made available that entitles TB patients to community-based poverty alleviation schemes. This would enhance access to treatment and address social and economic barriers to TB elimination. The region has seen good implementation of DOTS - the directly observed treatment, short course, which has resulted in relatively low multidrug resistance among newly detected TB cases. However, due to the large number of the total TB cases, the Region accounts for a third of the world's multidrug-resistant TB (MDR-TB) cases - 40335 MDR-TB cases reported among the regional 89, 000 estimated cases in 2013. A comprehensive package of TB-HIV interventions is available in the Region. Intensified case-finding is steadily increasing at integrated TB-HIV counselling, testing and care centres. India, Indonesia, Myanmar and Thailand - the high-burden countries for HIV - have strong TB-HIV referral and integrated management mechanisms. But more needs to be done. The battle against TB cannot be won until we address the underlying social determinants of poverty, sanitation and nutrition. We need to aggressively scale up efforts to meet TB elimination targets. Between 2015 and 2035, global targets are to reduce TB deaths by 95 percent, cut new cases by 90% and to ensure that no family is burdened with catastrophic expenses due to TB. ]]> <![CDATA[Govt will soon come up with 10 pharma clusters ]]> https://biospectrumindia.com/news/95/5626/govt-will-soon-come-up-with-10-pharma-clusters-.html https://biospectrumindia.com/news/95/5626/govt-will-soon-come-up-with-10-pharma-clusters-.html Mon, 23 Mar 2015 09:25:52 +0530 The government will soon come up with 10 pharma clusters in the country. Releasing the proceedings of the 12th National Pharmaceuticals Conclave on March 20, the union chemicals and fertilizers minister, Mr Ananth Kumar said that these clusters will provide common facilities to the pharmaceutical industry, and help them hive off upto 25 percent of the cost, making them globally competitive. He said that for these clusters, a strategy has been decided for early implementation. The minister said that that there are valuable suggestions in the report which will be promptly examined, and taken up for action. He said that the Government wants to ensure that the four pillars of the industry - Quality, Affordability, Availability and Stability are in position. He said that the Government wants to provide health security for the poor people of the country, and this requires innovative strategies like supply of generic medicines, building domestic capacity in bulk drugs, and making pharma sector competitive. Mr Ananth Kumar said that unified policy, regulation and administration mechanism is required for the pharmaceutical industry, and he has recommended to the Prime Minister to set up a separate department for the same. He said that on the issue of Bulk drugs production in the country, Katoch committee report has been received in the Ministry, and an action plan is being prepared for its implementation. Once its recommendations are put in place, it will make Indian industry viable and competitive. Speaking on the occasion, the minister of state for chemicals and fertilizers, Mr Hansraj Gangaram Ahir said that close interaction with producers and consumers helps the Government in formulating a better policy. He said that industry and national growth go hand in hand. The 12th National Pharmaceuticals Conclave was jointly organized by the Confederation of Indian industry and Department of Pharmaceuticals, Govt of India in December 2014. The objective of the Conclave was to bring together all the stakeholders for facilitating meaningful discussions on the challenges and possible mechanisms for countering it. The Conclave was supported by all major industry associations and several Ministries of the Govt. of India. The Conclave deliberated on much-needed collaborative multisectoral approaches that meet the government's health policy objectives. The report of the conclave has suggestions, grouped into 11 broad groups. Indications have also been made against these suggestions on what is possible to be implemented immediately (within six months), what is possible to be implemented in the short term (6-12 months) and what will need a little longer term implementation phase (1 to 3 years). The specific recommendations under them have suggested actionable interventions and an indication of timeframe and responsible stakeholders. These groups include: 1) Single window clearance mechanism2) Inducing manufacturing clusters3) Unified policy mechanism4) Capacity building across functions5) Developing a national innovation strategy6) Creating innovation fund targeted towards specific therapy areas7) Streamlining IP operations8) Evidence-based price controls9) Greater industry academia collaboration10) Streamlining clinical trials11) Ensuring quality compliance. ]]> <![CDATA[Sanofi announces cardiovascular study results of Lyxumia ]]> https://biospectrumindia.com/news/95/4939/sanofi-announces-cardiovascular-study-results-of-lyxumia-.html https://biospectrumindia.com/news/95/4939/sanofi-announces-cardiovascular-study-results-of-lyxumia-.html Fri, 20 Mar 2015 12:30:39 +0530 The study showed that lixisenatide was non-inferior, although not superior, to placebo for cardiovascular safety. ELIXA full results will be presented on Monday, June 8, 2015, at the American Diabetes Association 75th Scientific Sessions in Boston by the ELIXA steering committee, chaired by Dr Marc Pfeffer. The results will also be included in the US New Drug Application of lixisenatide, which is on track to be resubmitted to the US Food and Drug Administration (USFDA) in the third-quarter of 2015. Lixisenatide is not approved in the United States. "The completion of the ELIXA study is a significant milestone for lixisenatide, which is the first GLP-1 receptor agonist with long-term cardiovascular safety data in people with diabetes who have high cardiovascular risk," said Dr Elias Zerhouni, president, global R&D, Sanofi. "Sanofi looks forward to submitting the results to health authorities worldwide." ]]> <![CDATA[Declining Ebola cases pose serious challenge to clinical studies]]> https://biospectrumindia.com/news/95/4959/declining-ebola-cases-pose-serious-challenge-to-clinical-studies.html https://biospectrumindia.com/news/95/4959/declining-ebola-cases-pose-serious-challenge-to-clinical-studies.html Fri, 20 Mar 2015 12:30:02 +0530 The steady decline in new Ebola cases presents a formidable challenge to current and future clinical trials of investigational treatments for the disease, as it will be more difficult to recruit study participants and demonstrate efficacy. According to Dr Daian Cheng, GlobalData's analyst covering infectious diseases, Ebola's dwindling incidence rate is having a direct impact on patient enrollment for clinical trials of therapeutic agents, as evidenced by two studies for antiviral drugs favipiravir and brincidofovir. Dr Cheng said, "On January 30, Chimerix announced the decision to cease clinical investigations of its experimental Ebola drug, brincidofovir, as only a handful of participants were able to be recruited for a single-armed clinical trial in Liberia. The disease's decreasing incidence meant the study was unlikely to reach a convincing conclusion regarding the drug's efficacy." In contrast, the analyst highlights the early success of anti-influenza drug, favipiravir (Avigan), in a clinical trial in Guinea. This product, currently marketed in Japan by FujiFilm Holdings Corporation, produced positive initial results, which encouraged the Guinea government to approve its use in a limited number of Ebola treatment centers. Dr Cheng explained, "The favipiravir trial was not hindered by low patient recruitment, possibly due to its earlier start date compared with the brincidofovir trial. The fact that Guinea's local incidence rate was higher than Liberia's might also have contributed to its outcome. "The information available from favipiravir's trial indicated that the drug could lower mortality rates and accelerate recovery in patients with low or moderate levels of Ebola virus in their blood. However, in the face of diminishing cases, its future use is uncertain." For pharmaceutical companies, the use of established antiviral agents certainly has its advantages, especially if a treatment can be positioned as an option for relieving an outbreak while still being useful and profitable for other indications when the outbreak subsides. "Overall, Ebola's current decline means vaccine and drug manufacturers will again need to weigh the risks and benefits of developing further interventions for a disease that goes through unpredictable cycles of intense outbreaks followed by its virtual disappearance," the analyst concluded. ]]> <![CDATA[DuPont opens an Innovation Application Center]]> https://biospectrumindia.com/news/95/4941/dupont-opens-an-innovation-application-center.html https://biospectrumindia.com/news/95/4941/dupont-opens-an-innovation-application-center.html Fri, 20 Mar 2015 12:26:46 +0530 DuPont Nutrition and Health has announced the opening of an Innovation Application Center in Gurgaon. The multi-million-dollar facility houses state-of-the-art equipment and capabilities to serve the food industry in the country. "According to industry estimates, the food industry in India is growing between 15 and 20 percent annually. We recognize that while the science of food is global, the taste and flavors of food are local," said Mr Matthias Heinzel, president of DuPont Nutrition and Health. He added, "As we develop those local solutions, we need to be able to work closely with our local customers on foods they are developing for their consumers. This Innovation Application Center provides that access and a place for us to share our innovation and expertise, to showcase what we can offer and to help our customers save valuable time in developing novel solutions for the market. Our India Innovation Application Center coupled with the DuPont Innovation Center network leverages a wealth of knowledge, science expertise and experience from all our experts globally." "The DuPont offering in India cuts across the landscape of food, from flour-based products to dairy to nutritional beverages and powders," added Mr Brian Jones, regional leader, DuPont Nutrition and Health, South Asia. He added, "Among the focus areas of the Innovation Application Center will be protective cultures for dahi and yogurt, soy protein products, ice-cream and more nutritious, Indian snacks and biscuits tailored to meet the regional taste and texture expectations. The center also will allow DuPont to introduce formulations that are more convenient and affordable for more food choices for the food industry. An example is the work ongoing with customers on increasing the shelf-life of products in hotter climates where cold chain technology is not available. In addition, as a global leader in probiotics, DuPont is working closely with Indian companies to develop probiotics for gut and immune health." ]]> <![CDATA[US pharma market value will approach $550 billion by 2020]]> https://biospectrumindia.com/features/95/8477/us-pharma-market-value-will-approach-550-billion-by-2020.html https://biospectrumindia.com/features/95/8477/us-pharma-market-value-will-approach-550-billion-by-2020.html Thu, 19 Mar 2015 13:50:23 +0530 The US pharmaceutical market is forecast to increase from an estimated value of $395.2 billion in 2014 to reach $548.4 billion by 2020, representing a compound annual growth rate (CAGR) of 5.6 percent, according to research and consulting firm GlobalData. The company's latest report states that this growth will be driven by a number of factors, including increasing healthcare expenditure, an aging population, the rising prevalence of chronic lifestyle diseases such as diabetes and obesity, universal and easy access to reimbursement for pharmaceutical product costs, and the 2010 Patient Protection and Affordable Care Act (PPACA). Mr Joshua Owide, GlobalData's director of healthcare industry dynamics, explains that the PPACA and its amendment, the Health Care and Education Reconciliation Act, continue to have a substantial impact on US citizens and the country's pharmaceutical industry. He said: "As the PPACA mandates health insurance coverage for all Americans, the US has witnessed increasing use of prescription drugs among individuals who are newly insured or have shifted to insurance plans that offer premium and cost-sharing subsidies. In 2014, spending on prescription drugs amounted to an estimated $275.9 billion, compared with $262.3 billion in 2013. "Around 20 provisions of the healthcare legislation are expected to have a direct or indirect impact on the volume of drug and biologic sales. As many as 32 million formerly uninsured citizens could enter the patient pool, resulting in new business worth $115 billion over a period of 10 years." GlobalData's report also notes that the US Food and Drug Administration (FDA) provides a transparent, well-structured and competent regulatory system to facilitate the approval of pharmaceutical products and consequently bolster market growth.Mr Owide continued: "New initiatives undertaken by the FDA to strengthen the review and approval process will be advantageous to the industry. Its strong patent system attracts research-based pharmaceutical companies and positively influences growth. "In 2014, 41 novel drugs were approved by the FDA, 17 of which were for the treatment of rare diseases. Schemes such as the FDA's Fast Track Development Program and Breakthrough Designation accelerate the approval of novel drugs and add value to the market by meeting demand more quickly." ]]> <![CDATA['CKD is increasing in India at an alarming rate']]> https://biospectrumindia.com/interviews/95/3879/ckd-is-increasing-in-india-at-an-alarming-rate.html https://biospectrumindia.com/interviews/95/3879/ckd-is-increasing-in-india-at-an-alarming-rate.html Thu, 19 Mar 2015 13:49:41 +0530 According to statistics, nearly 10 percent of the world's population suffer from kidney disease. Early chronic kidney disease (CKD) is a silent killer and a person may lose about 90 percent of kidney function before any symptoms are noticed. In an effort to combat this growing health crisis, Siemens Healthcare Diagnostics and the US-based National Kidney Foundation (NKF) have devised a simple urine test to help improve diagnosis of CKD and identify the disease early on. The NKF recommends that healthcare professionals screen for kidney disease with this simple urine ACR test during the annual physical examination of high-risk individuals. Q. Please elaborate on the ACR test developed for early detection of CKD in patients? A. Elevated levels of albumin in urine provide an early warning sign that the kidneys are not functioning properly. Screening for increased urinary albumin excretion can be performed by measuring the albumin-to-creatinine ratio (ACR) in a random spot collection. Ratios utilizing creatinine account for the variability of urine concentrations, ensuring the accuracy of untimed specimen collections. The analysis of a spot sample for the ACR is strongly recommended by most authorities. The other two alternatives (24-hour collection and timed specimen) are rarely necessary. (Source: Standard of Medical Care in Diabetes, America Diabetes Association Position Statement, Diabetes Care, Volume 27, Supplement 1, January 2004). Q. What is the potential of the renal diagnostic market across India?A. CKD is a condition affecting almost 200 million people around the world today. (Source: World Health Organization [who.org]). Of these, about 20-30 percent will develop a kidney disease, which is the most common complication of diabetes (Source: International Diabetes Federation). Early CKD often has no sign or symptoms. A person can lose up to 90 percent of their kidney function before experiencing any signs. (Source: National Kidney Foundation, kidney.org/kidneydisease/global-facts-about-kidney-disease). CKD is increasing in India at an alarming rate. The major risk groups are people with diabetes, hypertension, age group of 60 years and above and people with family history of kidney disease. In majority of the cases, it has been seen that the disease has been diagnosed when the kidney damage has progressed to a critical stage. Early diagnosis of kidney diseases thus becomes critical to avoid potential damage to the kidneys. The rising incidences of kidney diseases in India are leading to a huge potential for the diagnostic market. Q. Please explain the importance of early diagnosis and screening tests in the detection of kidney ailments? A.Over 1 billion people are at risk of kidney disease globally! Statistics quoted from the organizers of World Kidney Day indicate that this equates to 1 in 10 people for kidney disease. The major risk groups are diabetics, hypertensives, people with family history of kidney disease and people over the age of 60 years. Obesity also plays a very large part in the risk. Early diagnosis is paramount to detecting the disease early. This improves quality of life and can delay people from moving to transplantation or dialysis. Urine testing using the ACR test at the Point of Care is the fastest, most effective way to screen the 1 billion at risk. Q. How is Siemens healthcare aiming to increase awareness of these tests? A. Our strategic alliance with the NKF has been a large factor in the awareness of risk factors and how a very simple urine test (ACR) can be used to detect kidney disease in the 1 billion at risk individuals. We also advertise electronically around the world on these topics and on our website and through social media. Q. How is Siemens planning to market their ACR test? A. Siemens offers ACR testing at the POC with our Microalbustix urine strip (visual read), the CLINITEK Microalbumin-2 urine strip (used on our CLINITEK Status analyzer) and is offered on our central lab instrument, the CLNITEK Novus analyzer. Our strategic alliance with the NKF has been a large factor in the marketing of these products worldwide. Q. Any other thoughts that you can give on the subject? A. Siemens CLINITEK Microalbumin 2 Reagent Strips detect albumin and creatinine levels in urine, providing an albumin-to-creatinine ratio and allowing treatment to begin sooner.â€¢ Detect kidney disease at the earliest stages-albumin sensitivity as low as 10 mg/Lâ€¢ Ratios utilizing creatinine account for the variability of albumin results due to urine concentrationâ€¢ Provide results in one minuteâ€¢ Reduce transcription errors and wait time-when used in combination with CLINITEK Status family of analyzers, results can be electronically managed or printed The CLINITEK Microalbumin 2 Reagent Strips provide semi-quantitative results with a hard-copy report on the CLINITEK Status family of analyzers, making them ideal for point-of-care testing. Patient samples can be tested immediately during a physician, clinic or hospital visit, rather than sending them out and waiting for results. The strips are also convenient for testing random urine samples, eliminating the need to collect a timed sample. ]]> <![CDATA[Shantha to provide 37 million doses of Shan5]]> https://biospectrumindia.com/news/95/4674/shantha-to-provide-37-million-doses-of-shan5.html https://biospectrumindia.com/news/95/4674/shantha-to-provide-37-million-doses-of-shan5.html Thu, 19 Mar 2015 12:45:15 +0530 Sanofi Pasteur, the vaccines division of Sanofi, announced that its Hyderabad-based affiliate Shantha Biotechnics has delivered the first 400,000 doses of its pediatric pentavalent vaccine Shan5 to support the immunization of children in the cities of Gwalior and Jabalpur, both in the state of Madhya Pradesh, India. In December 2014, following a two-year international tender, Shantha was awarded to supply global health organizations with a total of 37 million doses of Shan5 in 2015 and 2016, in a ten-dose vial presentation. This tender provides the basis upon which purchase orders will be made for specific vaccine deliveries throughout the period, depending on country needs. "We are pleased to have obtained this first tender award since Shan5 was registered and WHO-prequalified in April 2014", said Dr Harish Iyer, CEO, Shantha. "As one of the strategic manufacturing platforms for Sanofi Pasteur, Shantha is delivering on its commitment to serve Indian health needs and provide access in underserved vaccine markets." The Shan5 vaccine will be used in the routine immunization programs of a number of Gavi-supported countries, enabling up to ten million children to receive protection from five pediatric diseases. "This supply illustrates how Shantha and Sanofi Pasteur meet public health needs", said Mr Olivier Charmeil, Sanofi Pasteur president and CEO. "We are proud to contribute to making high-quality vaccines accessible to more children in developing countries." ]]> <![CDATA[Coming soon: National Biotechnology Development Strategy II]]> https://biospectrumindia.com/news/95/4633/coming-soon-national-biotechnology-development-strategy-ii.html https://biospectrumindia.com/news/95/4633/coming-soon-national-biotechnology-development-strategy-ii.html Thu, 19 Mar 2015 11:18:23 +0530 Giving this information the Minister of State for Science & Technology, Mr YS Chowdary stated that the strategy seeks to address a number of identified challenges in terms of tailor-made human capital for scientific research and entrepreneurship; research priorities, resources, and core facilities. Mr Chowdary mentioned further, "Other areas to be addressed by the strategy include creation of investment capital; intellectual property regime; technology transfer, absorption, diffusion and commercialization; regulation standards and accreditation; biotechnology partnerships between public and private sectors both nationally and globally and public understanding of biotechnology." The draft policy is currently under discussion with all senior experts and stakeholders for finalization before release, the minister added. ]]> <![CDATA[ BIRAC 's 3rd foundation day: Biotech industry converges at Delhi ]]> https://biospectrumindia.com/news/95/4620/-birac-s-3rd-foundation-day-biotech-industry-converges-at-delhi-.html https://biospectrumindia.com/news/95/4620/-birac-s-3rd-foundation-day-biotech-industry-converges-at-delhi-.html Thu, 19 Mar 2015 10:57:44 +0530 The discussions will be inaugurated by the minister of state for science and technology, Mr Y S Chowdary and will mark the third foundation day of Biotechnology Industry Research Assistance Council (BIRAC) to be celeberated at a function in New Delhi. The theme for the foundation day is "Accelerating Innovations: India the Next Biotech Global Hub". Several eminent speakers from the field of Biotechnology including senior bureaucrats from DIPP, ICMR, Department of Pharmaceuticals and Senior Industry Leaders such as Dr Kiran Mazumdar-Shaw, CMD, Biocon will participate in panel discussions over the next two days. Among themes for discussion are topics like - India the next Global Biotech Hub: The status of our readiness?, India a Bio-manufacturing Hub: Bridging the Paradigm for Quality and Affordability, Leveraging Partnerships to Make in India : Collaborating with national and international partners for enhanced competency. A plenary talk on- 'Make in India': a Perspective on the Biotech Sector: the opportunities, the enablers and the challenges, is also scheduled to be delivered by the Chairman and Managing Director, Biocon Dr Kiran Mazumdar Shaw. Over 250 Scientists, Entrepreneurs & Industry Experts, and Policy Makers will participate. The focus of the discussion would be on India's readiness to meet the challenges of "Make in India" in the Biotech sector. BIRAC was established under the aegis of the Department of Biotechnology (DBT), Ministry of Science and Technology, as a Public Sector Undertaking three years ago and is mandated to foster and promote innovation research in biotech industries specially start-ups and SMEs. Today, BIRAC has more than 100 Young Entrepreneurs, nearly 250 companies and start-ups and 15 incubators supported as an important part of the Innovation ecosystem of the country. ]]> <![CDATA[India steps up efforts on genome sequencing of crops]]> https://biospectrumindia.com/news/95/5858/india-steps-up-efforts-on-genome-sequencing-of-crops.html https://biospectrumindia.com/news/95/5858/india-steps-up-efforts-on-genome-sequencing-of-crops.html Thu, 19 Mar 2015 10:56:38 +0530 Speaking in the Parliamnet on March 18, 2015, the minister of state for science and technology, Mr Y S Chowdary stated that number of government institutions are involved in the whole genome sequencing of a number of crops including vegetables and fruits. He said that among the vegetable crops, the sequence of tomato and potato have been completed as a part of international consortium and among fruits, mango genome is being sequenced. Mr Chowdary added that the Department of Biotechnology (DBT) is supporting research programs for using genome information for improving crop yield. It initiated a major program on inducing genome variation by Targeting Induced Local Lesions in Genomes (TILLING) which is being supported as Solanaceae Genome Initiative (SOL) phase II program in next five years. The ultimate objective of this program is to enhance shelf life in tomato and also improve its nutritional quality such as carotenoids and folate. "The DBT is also funding a major research program on Tomato metabolomics where information derived from genome sequence data would be used to enhance vitamins such as carotenoids and folate levels in tomato fruits, he mentioned. The S&T minister informed that the level of advancement made in this area is quite close to the international standard. ]]> <![CDATA[Dr Minoti Apte named 'Woman of the Year' in Australia]]> https://biospectrumindia.com/news/95/4465/dr-minoti-apte-named-woman-of-the-year-in-australia.html https://biospectrumindia.com/news/95/4465/dr-minoti-apte-named-woman-of-the-year-in-australia.html Wed, 18 Mar 2015 14:52:00 +0530 Dr Minoti Apte, a 56-year-old pancreatic researcher, has been named the New South Wales 'Woman of the Year' 2015 for her contributions to medical research, tertiary education and the Indian community in Australia. Dr Apte received the award from NSW Premier Mr Mike Baird and Minister for Women Mr Pru Goward during a reception at NSW Parliament House recently. Dr Apte was also the recipient of Order of Australia Medal (OAM) last year for her services to medical research. On winning the award, said Dr Apte, "I would like to acknowledge the wonderful support of members of the Pancreatic Research Group, my current PhD students Mr Zhihong Xu and Ms Sri Pothula and my mentors Professor Jeremy Wilson and Professor Ron Pirola." Dr Apte further stated that gender inequality and certain disadvantages for women returning to work remains a big problem in Australia and more work needs to be done in this area. Dr Apte is currently the director of the Pancreatic Research Group and is an acknowledged world-leader in alcohol-induced pancreatic injury and pancreatic cancer. Dr Apte was the first in the world to develop a method to isolate pancreatic stellate cells, a technique which provided much needed research tool for studying how pancreatic fibrosis progresses in patients. She is currently leading pre-clinical studies for new drugs that can treat pancreatic cancer. ]]> <![CDATA[Zydus launches its Hepatitis C drug, SoviHep]]> https://biospectrumindia.com/news/95/7497/zydus-launches-its-hepatitis-c-drug-sovihep.html https://biospectrumindia.com/news/95/7497/zydus-launches-its-hepatitis-c-drug-sovihep.html Wed, 18 Mar 2015 14:09:15 +0530 Zydus in alliance with Gilead Sciences has launched an oral -therapy for Hepatitis C, SoviHep. The company has signed a non-exclusive licensing agreement which will allow the manufacture of sofosbuvir and the fixed-dose combination of ledipasvir/sofosbuvir for distribution in 91 countries including India. The therapy will be marketed by the specialty division of the group, Zydus Heptiza. Hepatitis C is the leading reason for liver transplantation, though the virus usually recurs after transplantation. For over a decade in India, the disease has been treated with PEG-IFN along with Ribavirin. However, the management of the disease has been a challenge with less than 1 percent of 10 million Hepatitis C patients having access to treatment. The launch of SoviHep is expected to improve the situation as it takes care of all current treatment needs of PAN-genotypic activity, with barrier to resistance, potent with convenience and compliance therapy. SoviHep can also be used in combination with ribavirin (RibaHep) for treatment of chronic Hepatitis C patients with hepatocellular carcinoma awaiting liver transplantation for up to 48 weeks or until liver transplantation to prevent post-transplant HCV infection. Speaking on the development, chairman and managing director of Zydus group, Mr Pankaj R Patel said, "Innovations in healthcare have made it possible to deliver better therapy outcomes and improve quality of lives. We are happy to partner with Gilead Sciences to make this breakthrough therapy accessible to patients of Hepatitis C in India. It bridges a longstanding unmet healthcare need. It also underlines our mission of providing access to new affordable therapies and we stand committed to this." ]]> <![CDATA[Teva sells its oncology business to Ignyta]]> https://biospectrumindia.com/news/95/4375/teva-sells-its-oncology-business-to-ignyta.html https://biospectrumindia.com/news/95/4375/teva-sells-its-oncology-business-to-ignyta.html Wed, 18 Mar 2015 12:47:24 +0530 Teva Pharmaceutical has announced that Ignyta has acquired its worldwide rights and assets relating to four targeted oncology development programs. This is in exchange for 1.5 million shares (6 percent) of Ignyta's common stock. Concurrently, Ignyta has entered into stock purchase agreements with Teva, and selected additional healthcare investors, whereby Teva will purchase a further 1.5 million shares of common Ignyta stock at a price of $10 per share in a registered direct offering. The other investors will purchase an additional 2.7 million shares at $10 per share, valuing the total offering at approximately $41.6 million. "Teva has committed to finding novel ways for the ongoing development of early clinical stage and pre-clinical oncology R&D programs, which hold significant promise for cancer patients. Ignyta's capabilities and focus in oncology will give these assets the best chance of realizing their potential for patients, and of maximizing their value for Teva," said Mr Michael Hayden, Teva's president of global R&D and chief scientific officer. "Acquiring these four development stage programs from Teva is truly transformational for Ignyta and well aligned with our strategic focus on developing first-in-class and best-in-class precision medicines to help cancer patients with unmet needs," said Dr Jonathan Lim, chairman and CEO, Ignyta. He added, "These oncology programs add critical mass to our pipeline and further enable us to leverage our precision oncology platform, including our proprietary multiplex diagnostic assays and our CLIA certified, QSR compliant diagnostic laboratory. Furthermore, these new assets complement our entrectinib development program and extend our ability to target the majority of known oncogenic drivers across multiple solid tumor indications. For example, in non-small cell lung cancer alone, we believe that our product candidates have potential activity against many of the most frequent oncogenic drivers in this disease, and we plan to explore these opportunities through innovative clinical trial designs such as master protocols." ]]> <![CDATA[India gets an Epilepsy lab]]> https://biospectrumindia.com/news/95/5392/india-gets-an-epilepsy-lab.html https://biospectrumindia.com/news/95/5392/india-gets-an-epilepsy-lab.html Tue, 17 Mar 2015 15:29:31 +0530 AIIMS in association with the National Brain Research Centre (NBRC) have set up an advanced Epilepsy Neurobiology lab, to improve diagnosis of patients and identify the cause of the disease at a cellular-level. The lab set up in Manesar, is headed by Dr P Sarat Chandra of Neurosurgery and Dr Manjari Tripathi of Neurology, AIIMS. "The aim is to understand the mechanisms of this complex disease so that the knowledge obtained from research can be applied to enhance the outcome of surgeries," said Dr P Sarat Chandra, professor of Neurosurgery at AIIMS. The neurobiology lab boasts of advanced research facilities to perform single neuron cell recordings and also to perform complex molecular and cellular analysis of brain samples in patients who have undergone epilepsy surgery to understand better about its mechanisms. ]]> <![CDATA[Actavis' acquisition of Allergan gets EU nod]]> https://biospectrumindia.com/news/95/6640/actavis-acquisition-of-allergan-gets-eu-nod.html https://biospectrumindia.com/news/95/6640/actavis-acquisition-of-allergan-gets-eu-nod.html Tue, 17 Mar 2015 13:47:21 +0530 Actavis has announced that the company has received clearance from the European Commission for its pending acquisition of Allergan. Clearance by the European Commission satisfies the final regulatory condition to the closing of the pending acquisition, which remains subject to certain customary closing conditions and is expected to be effective on or around March 17, 2015. Actavis has acquired Allergan for $66 billion. ]]> <![CDATA[Lupin acquires Pharma Dynamics]]> https://biospectrumindia.com/news/95/3781/lupin-acquires-pharma-dynamics.html https://biospectrumindia.com/news/95/3781/lupin-acquires-pharma-dynamics.html Tue, 17 Mar 2015 13:27:53 +0530 Lupin has entered into an agreement to acquire the balance 40 percent equity stake in South African generic drugmaker Pharma Dynamics (PD), as per a stock market disclosure. Lupin previously had acquired 60 percent stake in PD in September 2008. "Lupin has been an extremely strong partner in our business since 2008. The fact that Lupin has increased its shareholding is a huge compliment," said Mr Paul Anley, chief executive officer, PD, in a statement. PD is among the top 20 drugmakers in South Africa and the third-largest generics firm in the prescription drugs market in the country. "We are delighted with this development as Africa is fast emerging as one of the growth engines of the future. We are pleased that Mr Paul Anley has agreed to continue as CEO," said Ms Vinita Gupta, CEO of Lupin.â€ƒ ]]> <![CDATA[DBT to fund R&D projects in food allergy ]]> https://biospectrumindia.com/news/95/6148/dbt-to-fund-rd-projects-in-food-allergy-.html https://biospectrumindia.com/news/95/6148/dbt-to-fund-rd-projects-in-food-allergy-.html Tue, 17 Mar 2015 12:13:27 +0530 Food Allergy is an abnormal immunological response to certain foods in susceptible subjects. It is estimated that 4 percent of adults and 8 percent of children may be allergic to one food or the other at any time. There is a need for studies on the incidence, experimental approaches, and therapeutic aspects of food allergy for its treatment and management. Taking this into account, the Department of Biotechnology (DBT) has solicited R&D proposals in identified thrust areas, starting from the generation of prevalence and incidence of food allergy in India. Also, the generation of prevalence data from community or population representative of entire country; development of structured and harmonized protocol for a pilot study that may be used in subsequent all India study. Other research proposals could be to find out the Clinical spectrum of food allergy; multidisciplinary approaches having allergists as coordinators representing different regions of India; immunotherapy for food allergy. Also, the experimental approaches towards food allergy; simultaneous detection methods of multiple food allergens; development of in vivo/ in vitro models for food allergy; development of non-invasive biomarkers for food allergy and studies of food allergy associated with newer diseases like (only suggestive) eosinophilic gastrointestinal diseases (non IgE mediated). The proposals may be submitted by scientists or interdisciplinary groups working in recognised R & D Institutions. The proposals will be examined by constituted expert committee for consideration of financial support by DBT. These can be submitted online on Open DBT epromis website (http://dbtepromis.nic.in/login.aspx) by May 15, 2015. ]]> <![CDATA["Greenpeace's opposition to Golden rice not justified"]]> https://biospectrumindia.com/news/95/8318/greenpeaces-opposition-to-golden-rice-not-justified.html https://biospectrumindia.com/news/95/8318/greenpeaces-opposition-to-golden-rice-not-justified.html Tue, 17 Mar 2015 10:49:49 +0530 According to the World Health Organization (WHO), Vitamin A deficiency (VAD) is the leading cause of preventable blindness in children and increases the risk of disease and death from severe infections. In pregnant women, VAD causes night blindness and may increase the risk of maternal mortality. Now as a possible answer, Golden Rice is a new type of rice that contains beta carotene, a source of vitamin A, thus a potential new food-based approach to the issue. However, opposition from Greenpeace and NGOs has led to political pressure on respective governments in developing nations leading to reluctance to give a go ahead for its cultivation. The latest examples among these is China. Visiting India as part of his 'Allow Golden Rice Now' campaign, Dr Patrick Moore, an international environmental leader and a founding member of Greenpeace, is trying to spread awareness on the issue. His campaign seeks to address the problem related to the high incidence of Vitamin A deficiency in India. The Golden Rice Tour began with a field trip to the International Rice Research Institute near Manila, the lead agency internationally for the development of Golden Rice. Dr Moore belives that had the Golden Rice been a cure for a disease like Malaria, Cancer, or Ebola, it would have been approved years ago. "It is time the international community intervened in this humanitarian tragedy. Our tour to promote the positive message of Golden Rice has been met with heavy resistance from anti-capitalist activists, 20 of which have joined forces to oppose our Indian leg of our tour," he said. Dr Moore further added, "It is a testament to the uncaring attitude of Greenpeace and other NGOs that they will not drop their opposition to Golden Rice. Golden Rice has been proven to deliver vitamin A to both adults and children so there is certainty that it could save millions of lives. Can you imagine the grief of millions of poor parents who watch helplessly while their young children perish before their eyes?" Vitamin A deficiency affects more than 35 million children globally including in India. Worldwide, about 2 million children die every year from diseases related to vitamin A deficiency, and between 250,000 and 500,000 go blind. Vitamin A deficiency is the biggest killer of children in the world today. Golden Rice is the obvious cure, but because it was created with genetic science, Greenpeace and the anti-GMO movement fervently oppose it. No country has approved it for cultivation Economists from the Technical University of Munich and the University of California, Berkeley, have quantified the price of the opposition in terms of human health. The study, published in the journal Environment and Development Economics, estimates that the delayed application of Golden Rice in India alone has cost 1.4 million life years since 2002. This accounts not only for those who died, but also for the blindness and other health disabilities that Vitamin A deficiency causes. The majority of those who went blind or died have been children. The Golden Rice Network includes eighteen national, developing country institutions in Bangladesh, China, India, Indonesia, Nepal, South Africa, Philippines, and Vietnam. The Network is under the strategic guidance of the Golden Rice Humanitarian Board and under the management of a network coordinator, based at the International Rice Research Institute (IRRI), in the Philippines. Vitamin A deficiency is a public health problem in more than half of all countries, especially in Africa and South-East Asia, hitting hardest young children and pregnant women in low-income countries. Crucial for maternal and child survival, supplying adequate vitamin A in high-risk areas can significantly reduce mortality. Conversely, its absence causes a needlessly high risk of disease and death. ]]> <![CDATA[Boehringer loses India patent to Cipla]]> https://biospectrumindia.com/news/95/3945/boehringer-loses-india-patent-to-cipla.html https://biospectrumindia.com/news/95/3945/boehringer-loses-india-patent-to-cipla.html Mon, 16 Mar 2015 15:53:59 +0530 In a landmark decision, India's patent office has revoked the patent of German-based pharmaceutical giant Boehringer Ingelheim's chronic obstructive pulmonary disease drug Spiriva (tiotropium). Back in 2012, Boehringer received its Indian patent on Spiriva, which extended up to 2021. In 2013, Cipla filed its patent opposition saying the drug didn't constitute invention under India's patent laws. ]]> <![CDATA[ Lancet study reveals worrisome picture for kidney failures]]> https://biospectrumindia.com/news/95/8434/-lancet-study-reveals-worrisome-picture-for-kidney-failures.html https://biospectrumindia.com/news/95/8434/-lancet-study-reveals-worrisome-picture-for-kidney-failures.html Mon, 16 Mar 2015 11:28:28 +0530 Latest research by The George Institute for Global Health published today in The Lancet shows that each year more than two million people globally die unnecessarily because they cannot access treatment for kidney failure (dialysis or a kidney transplant). The research shows that the largest number of these preventable deaths occurred in India, China, Indonesia, Pakistan, and Nigeria, where less than a quarter of eligible patients receive treatment for kidney failure. Lead author, Professor Vlado Perkovic of The George Institute, said the findings present a grim picture of the prevalence of kidney failure, which is worse than previously thought. "The sad reality is that most of these deaths are preventable and the biggest burden lies in low to middle income countries where there are instances of less than a quarter of patients receiving treatment for kidney failure," he said. "The data shows that previous estimates of the number of patients who develop end stage kidney failure and die without getting treatment in India seem to be gross under-estimate. Over coming decades the number of patients with kidney failure rates will grow rapidly and millions of people appear doomed to die without access to dialysis without specific action, with India being hit hard," said Prof. Vivekanand Jha, executive director, The George Institute Global Health, India and Secretary, Indian Society of Nephrology. "We urgently need to find ways to get people the treatment they need by making dialysis affordable, and by implementing preventative measures so fewer people develop kidney failure in the first place," he said. Explaining the correlation of Chronic Kidney Disease (CKD) in disadvantaged populations in India, Prof. Jha said, "Poverty-related factors such as infectious diseases secondary to poor sanitation, inadequate supply of safe water, environmental pollutants and high concentrations of disease transmitting vectors continue to play an important role in the development of CKD in low-income communities in India. A high prevalence of CKD of unknown aetiology has been reported in rural agricultural communities from India too. The strong association with farm work has led to suggestions that exposure to agrochemicals, dehydration and consumption of contaminated water are probable causes." "Effective kidney disease prevention strategies include controlling blood pressure and glucose levels, taking proven protective medications and managing key risk factors like diabetes and obesity, but archaic and inconsistent models of care and gaps in treatment such as lack of access to local health professionals stop people from getting these." The cost of dialysis is a major barrier in low and middle-income countries including India, and the impact on health expenditure is vastly disproportionate to the numbers of people who use it. In the US for example, dialysis provision costs over $40 billion, consuming over 6 percent of health expenditure for treating a fraction of a percent of the population. "In India, less than 10 percent of all End Stage Renal Disease (ESRD) patients have access to Renal Replacement Therapy (RRT). Despite recent progress, the transplant rates remain abysmally low. There are major disparities in renal care in India, with poorer states having fewer nephrologists and dialysis and transplant facilities. As a result, people living in these states receive less care," said Prof. Jha "An Indian study shows, over 70 percent of patients undergoing kidney transplantation experienced catastrophic health-care expenditures. Entire families felt the impact of this, including job losses and interruptions in education of children. In India almost two-thirds of the patients are unable to continue dialysis beyond the ï¬?rst 3 months because of ï¬?nancial reasons," added Prof. Jha The way forward "Dialysis has been around for half a century, yet the technology hasn't evolved substantively, remaining hugely expensive despite its simplicity," explained Professor Perkovic, "Computers have shrunk from the size of buildings to that of a watch in this time; that's the kind of radical overhaul needed." As a result of this research, a world-wide competition is being launched today to design the world's first affordable dialysis machine, attracting a prize of $100,000. "Dialysis machines purify the blood, replacing an essential function of the kidneys. If we can develop an affordable dialysis machine with low operating costs, that runs on solar power and uses local water sources, many more people will have access to the treatment and millions of lives could be saved," said Professer Jha. "India is a hub for developing affordable innovation, and we expect that Indian scientists and engineers will take this up as a challenge in the spirit of the Prime Minister Modi's call for 'Make in India' and help millions of patients with end stage kidney failure not only in India, but worldwide." The competition is sponsored by The George Institute, the International Society of Nephrology and the Asian Pacific Society of Nephrology, with the support of the Farrell Family Foundation. Incoming president of the International Society of Nephrology, Professor Adeera Levin of the University of British Columbia said that the International Society of Nephrology is proud to support the Affordable Dialysis Prize. "We hope it will attract interest around the world, particularly in those countries where kidney patients stand to benefit the most from creative, innovative approaches to treatment at a price everyone can afford," said Professor Levin ]]> <![CDATA[Biosafety tests of GM crops a necessity: WHO]]> https://biospectrumindia.com/news/95/5352/biosafety-tests-of-gm-crops-a-necessity-who.html https://biospectrumindia.com/news/95/5352/biosafety-tests-of-gm-crops-a-necessity-who.html Mon, 16 Mar 2015 11:21:48 +0530 In order to build awareness about food safety among various stakeholders, the World Health Organization on 13 March 2015, organized a technical briefing for mediapersons. The event, held in Delhi, was for discussing the theme of World Health Day 2015, 'From farm to Plate, keep food safe' Various speakers representing WHO, Food Standards and Safety Authority of India (FSSAI), and National Center for Disease Control (NCDC) presented on their respective roles in ensuring awareness about the need to have safe food. Replying to a question raised by BioSpectrum on WHO's position on GM crops, the WHO's representative maintained that GM crops should be evaluated extensively and the balance must be maintained. Since there is a foreign gene being inserted in to a plant genome, it is the matter of choice for consumers but we believe that can be done after proper tests. "FAO/WHO Codex guidelines exist for risk analysis of GM food. We have been a part of consultations at the multiple levels and will continue to give our inputs whenever required. We are working on it," she said while speaking on the occasion. Dr Anil Kumar, additional director, NCDC, Delhi gave insights about the role of organization in providing quick response to the outbreaks. He added, "The institute was, in addition, expected to provide expertise to the States and Union Territories (UTs) on rapid health assessment and laboratory based diagnostic services. Surveillance of communicable diseases and outbreak investigation also formed an indispensable part of its activities." "The challenge for food regulators is to maintain a food regulatory system that delivers safe food for the population, enables consumers to make informed choices and also maintains public confidence in the food regulations," mentioned the FSSAI representative. At present, the global instruments to ensure food safety and public health includes the International Health Regulations (IHR) 2005; INFOSAN which is International Food Safety Network of food safety authorities managed jointly by FAO & WHO for information exchange and cooperation. Besides that there is CODEX Alimentarius, the Global standards setting based on scientific evidence concerning hygienic and nutritional quality of food (WHO & FAO joint program). ]]> <![CDATA[Ventureast invests $4 mn in DiabetOmics]]> https://biospectrumindia.com/news/95/4244/ventureast-invests-4-mn-in-diabetomics.html https://biospectrumindia.com/news/95/4244/ventureast-invests-4-mn-in-diabetomics.html Fri, 13 Mar 2015 12:20:26 +0530 DiabetOmics is the world's first company to develop a patented non-invasive, saliva-based glucose monitoring test for diabetes patients and an early detection test for gestational diabetes (in pregnant women) and pre-eclampsia (high blood pressure in pregnant women). The investment will be used to advance product development, obtain regulatory approvals in EU, USA and in emerging markets, set up manufacturing facility in India and begin commercialization. The company plans to obtain CE Mark in the second half of 2015, and commence commercialization in India and several other countries in early 2016. Mr Srinivasa Nagalla, president & CEO, DiabetOmics, commented, "India has earned the dubious distinction of being the diabetes capital of the world. Lack of patient compliance with regular glucose monitoring is the primary cause of diabetes-related complications. Our portable, easy-to-use device helps patients and their physicians stay informed of the status of the disease. We are extremely pleased with the investment we have received from Ventureast. We are looking to grow our presence in India to access Indian and SE-Asian markets." Ventureast's Life Fund focuses on investments in cleantech, food & agriculture, and healthcare sectors. Then fund has previously made cross-border deals in drug discovery, medical devices, diagnostics, biotechnology and healthcare delivery. Mr Venkatadri Bobba, general partner, Ventureast, opined, "An important focus area for us has been investing in companies fostering cutting-edge and breakthrough innovations in healthcare. We believe that DiabetOmics' device is a game-changer and will definitely be successful in India." ]]> <![CDATA[Karnataka to introduce a rare disease policy soon]]> https://biospectrumindia.com/news/95/4511/karnataka-to-introduce-a-rare-disease-policy-soon.html https://biospectrumindia.com/news/95/4511/karnataka-to-introduce-a-rare-disease-policy-soon.html Fri, 13 Mar 2015 10:16:19 +0530 Karnataka government is all set to introduce a policy for rare diseases in the state. This would be the first state in the country to do so. Speaking to BioSpectrum, Mr Harsha K Rajasimha, founder member of the Organization for Rare Diseases in India (ORDI) informed, "We have an ongoing effort to develop a state level rare disease health policy for Karnataka which the vision group on biotechnology has been tasked with. We are in the final stages of fomalizing the same. This would be introduced shortly," he said. However, estimates are tenuous in the absence of any quantitative database of the approximately 7,000 types of illnesses that fall under the rare disease category. The classification of rare diseases is also arbitrarily specified in different countries and not specified in India at all. However, a disease where less than 1 in 2,000 of a country's population is affected is a generally accepted norm. The nature of the problem is that rare diseases are generally not curable, but they can be controlled. This means that treatment is lifelong and invariably expensive. By virtue of being rare diseases, they do not elicit the enthusiastic attention of researchers, medical practitioners and drug manufacturers. As a result, diagnosis is invariably delayed. In almost all cases, delays in diagnosis extend the suffering of patients and caregivers. ORDI plans to represent the collective voice and advocate the needs of patients with rare diseases and other stakeholders in India. The ORDI team members come from diverse backgrounds such as genetics, molecular diagnostics, drug development, bioinformatics, communications, information technology, patient advocacy and public service. ORDI aim to be the umbrella organization, uniting and providing a common forum for all individual disease-speciï¬?c organizations in India. It will have branches in all the state capitals. It will collaborate with other parent support groups and help to initiate new parent groups for disorders that currently do not have one. It will obtain funds from corporate houses, pharmaceutical companies, private genetic laboratories and foundations both in India and abroad. ]]> <![CDATA[Big pharma drives innovation in pain therapy development]]> https://biospectrumindia.com/features/95/6761/big-pharma-drives-innovation-in-pain-therapy-development.html https://biospectrumindia.com/features/95/6761/big-pharma-drives-innovation-in-pain-therapy-development.html Fri, 13 Mar 2015 10:02:55 +0530 Patent applications for novel pain therapeutics declined steadily in number from 4,970 in 2008 to 3,492 in 2012, an average annual decrease of 8 percent, as limited understanding of pain pathophysiology continues to hinder drug development in this arena, says business intelligence provider GBI Research. The company's latest report states that patent applications for pain treatments between 2008 and 2012 were dominated by big pharma, including Sanofi, Novartis and Merck, which submitted 169, 162 and 142 applications, respectively. However, the global pain treatment market is dominated by opioids and steroidal anti-inflammatory drugs, with no novel products currently able to challenge these products' efficacy in treating moderate to severe acute pain. Furthermore, despite the significant unmet needs for more effective therapies in other pain subtypes, such as chronic and neuropathic pain, due to their rising prevalence, the factors underpinning these subtypes are complex and poorly understood. However, this limited knowledge is being countered by technological advances and significant research efforts, with new insights translating into an expanding pool of novel therapeutic targets. The company states that the overall pain therapy pipeline is exceptionally large and moderately diverse, with a number of molecules boasting different mechanisms of action to those seen in the current market landscape. This offers a high probability of producing strong market entrants in the near future. Indeed, among the 111 first-in-class pipeline products available for strategic consolidations, some have shown promising preclinical evidence and significant potential to become game-changing treatments, representing high-reward investments. Such innovation in the pain therapeutics field is being driven primarily by big pharma, due to the large number of patent grants awarded to these companies for their treatments between 2008 and 2012. Merck boasted the highest number of patent grants during this period, with 59, while Boehringer Ingelheim and Allergan achieved 35 and 34, respectively, and Sanofi and Novartis both achieved 30. ]]> <![CDATA[Health expenditure remains only 1.2% of GDP in 2014]]> https://biospectrumindia.com/news/95/6337/health-expenditure-remains-only-1-2-of-gdp-in-2014.html https://biospectrumindia.com/news/95/6337/health-expenditure-remains-only-1-2-of-gdp-in-2014.html Thu, 12 Mar 2015 12:48:38 +0530 The Modi government has not given any exceptional treatment to the healthcare sector in the recently presented budget 2015-16. The government announced 297 billion rupees ($4.81 billion) for healthcare, roughly 2 percent higher than current year's revised budget of 290 billion rupees. Earlier a senior health ministry official had told BioSpectrum that India's constraints on reforms are a hinderance and had stressed on finding innovative alternatives. "Technologies will have to play an important role in meeting requirements. We have to shift priorities towards innovation development and delivery of quality products," he had mentioned. The health minister, Mr J P Nadda in a written reply in the Rajya Sabha on March 10, 2015, stated that as per Economic Survey 2014-15, the expenditure by the government (central and state combined) on health as percentage of Gross Domestic Product (GDP) for 2014-15 (BE) is 1.2 per cent. However, Mr Nadda mentioned that as per 12th Five Year Plan document, total public funding by the Centre and States, plan and non-plan, on core health is envisaged to increase to 1.87 per cent of GDP by the end of the 12th Plan. "When viewed in the perspective of the broader health sector, the total government expenditure as a proportion of GDP is envisaged to increase to 2.5 per cent by the end of the 12th Plan," said the minister. Mr Nadda also pointed out that the draft National Health Policy 2015 envisages health care service being built on the bedrock of high quality comprehensive primary health care services that are universally accessible, are free and provided as close to where people live and work, as is feasible. Perhaps the government has ensivaged a different pathway to reach the health goals. While the allocations tell a different story, government officials seem to be divided on the issue. While aome are enthusiastic about the new initaitives, quite a few are skeptical on the launch of programmes minus enough financial support to sustain them. "Might be possible that government wants to focus on proper utilization of funds and less on mere allocations. The affordability from indigenious manufacturing can be a huge boost. The longterm mutually beneficial partnership with industry can make it possible," quipped a senior industry person. ]]> <![CDATA[DuPont achieves top sustainability certification]]> https://biospectrumindia.com/news/95/6708/dupont-achieves-top-sustainability-certification.html https://biospectrumindia.com/news/95/6708/dupont-achieves-top-sustainability-certification.html Thu, 12 Mar 2015 12:33:30 +0530 DuPont has been awarded the prestigious LEED Certification in Gold Category for the DuPont Knowledge Center (DKC) in Hyderabad. The award is granted by the United States Green Building Council (USGBC) for Existing Buildings Operations and Maintenance (EBOM). Mr Ranjan Patnaik, director, DKC, said, "This certification stands testimony to our respect for environment. The energy-efficient design and eco-friendly maintenance features used in the center aim to conserve and preserve rather than waste and exploit the natural resources, offering a healthier and cleaner environment. We feel honoured to have been recognised for our environmental achievements." LEED (Leadership in Energy and Environmental Design) is a green building certification program that recognizes best-in-class building strategies and practices. LEED certified buildings are known to save money and resources and have a positive impact on the health of occupants, while promoting renewable, clean energy. DuPont Knowledge Center (DKC), Hyderabad, was inaugurated in 2008 and operates in a 25 acre campus in IKP Knowledge Park at Genome Valley near Hyderabad. Over 400 scientists and engineers work at this center. In collaboration with over 10,000 DuPont scientists and engineers around the world, DKC is already LEED Silver certified by Indian Green Building Council (IGBC) in March 2010 for successfully achieving the Green Building Standards required under LEED India Green Building Rating system for new construction. ]]> <![CDATA[Another mobile firm forays into healthcare]]> https://biospectrumindia.com/news/95/4987/another-mobile-firm-forays-into-healthcare.html https://biospectrumindia.com/news/95/4987/another-mobile-firm-forays-into-healthcare.html Wed, 11 Mar 2015 13:22:37 +0530 Intex Technologies has now entered into medical tourism with its latest venture Intex Care. The company aims to seamlessly integrate its services through its world renowned network of hospitals in India and all across the globe. The healthcare division of the organisation is looking at cater to patients globally in need of an affordable world class medical treatment. Through its current network of partner hospitals in five cities at Delhi (NCR), Mumbai, Chennai, Bengaluru and Kolkata, Intex Care will look to facilitate a wide array of services such as Plastic/Cosmetic Surgery, Orthopaedics Surgery, Dental Surgery, Heart/Cardiac Surgery, Eye/Ophthalmologic procedures, General Surgery, Neuro Surgery, Cancer treatment, Liver, Kidney and Bone Marrow Transplant and many more. "One of the critical pain points in the medical treatment is the provision of world class healthcare services at an affordable cost. This has been a major point of contention for several years now and we are in a position to contribute towards this change. Therefore, with Intex Care it is our endeavour to create the strongest bonds ensuring wellness and healthy life cutting across the age groups of people in India and the world. With this, we are committed to facilitating globally acknowledged medical care at the most affordable prices with a network of our partner multi-super specialty hospitals," said Mr Pankaj Goel, director, Intex Care. At the moment, Intex Care is present in the leading metro cities of the country and will look to extend their medical and healthcare services to other parts of the world and the much needed tier 2 and 3 as well as rural segments of India. ]]> <![CDATA[A new cluster development program for pharma]]> https://biospectrumindia.com/news/95/6524/a-new-cluster-development-program-for-pharma.html https://biospectrumindia.com/news/95/6524/a-new-cluster-development-program-for-pharma.html Wed, 11 Mar 2015 12:51:11 +0530 Reportedly, the government is planning a Cluster Development Program for the pharma sector (CDP-PS) with an estimated Rs 125 crore in the ongoing five-year plan. The scheme would be implemented under the Public Private Partnership (PPP) format through a one time grant-in-aid to be released in various phases for creation of identified infrastructure and common facilities. Some of the indicative activities under the common facilities are common testing facilities, training center, effluent treatment plant, R&D centers and common logistics center. The department is in the process of appointing project management consultant for implementing the CDP-PS. ]]> <![CDATA[Ranbaxy Science Foundation honours outstanding scientists]]> https://biospectrumindia.com/news/95/6688/ranbaxy-science-foundation-honours-outstanding-scientists.html https://biospectrumindia.com/news/95/6688/ranbaxy-science-foundation-honours-outstanding-scientists.html Wed, 11 Mar 2015 12:11:39 +0530 The coveted Ranbaxy Research Awards in the field of medical sciences were given to Dr Amit Sharma, International Center for Genetic Engineering and Biotechnology, New Delhi for his pioneering work in understanding the function of malaria parasite proteins. Dr Balram Bhargava, All India Institute of Medical Sciences, New Delhi was awarded for his work on developing the indigenous low cost platinum iridium coronary stent; Dr Gagandeep Kang, Christian Medical College, Vellore for his comprehensive research on diarrhoeal disease that led to important advances in Indian public health and Dr V Mohan, Dr Mohan's Diabetes Specialities Center, Chennai for his research work on pancreatic diabetes that led to the development of "Mohan's criteria". In the field of Pharmaceutical Sciences, the sole award was given to Dr Santanu Bhattacharya, Indian Institute of Science, Bangalore for his work promoting gene therapy. The Science Scholar Awards, given to upcoming new generation of scientists in the Biomedical Sciences category went to Mr Anuj Kumar, Indian Institute of Science, Bangalore for his research work in understanding hepatitis C virus replication and Mr Bidyut Purkait, Department of Molecular Biology, Rajendra Memorial Research Institute of Medical Sciences (RMRIMS) (ICMR) Patna for designing better chemotherapeutic options for kala-azar. In the Pharmaceutical Sciences category, the awardees were Ms Preshita P Desai, Institute of Chemical Technology, Mumbai for the development and scale up optimization of curcumin solid solution; Ms Jasmine Kaur, National Institute of Pharmaceutical Education and Research, Punjab for the development of a diagnostic agent called Aptamer used both for detecting cancer and delivering pharmaceutical substances specifically to cancerous cells and Mr Bhushan Munjal, National Institute of Pharmaceutical Education & Research (NIPER), Punjab for his work on lyophilization used to preserve perishable material and make them convenient for transport. The awards were presented by internationally acclaimed scientist, Prof. Rudi Balling, director, Luxembourg Center for Systems Biomedicine (LCSB), University of Luxembourg in presence of Dr Tsutomu Une, chairman, Ranbaxy, Dr Nitya Anand, chairman of RSF, Mr Arun Sawhney, chief executive officer and MD, Ranbaxy and Dr Rajinder K Jalali, member, Governing Council, RSF. Preceding the award ceremony, Ranbaxy Science Foundation also held its 21st Annual Symposium on "Neurodegeneration" which saw participation of Mr TS Rao, Department of Biotechnology, Government of India; Mr Nirmal Kumar Ganguly, Policy Center for Biomedical Research, Translational Health Science & Technology Institute; Ms MV Padma Srivastava, All India Institute of Medical Sciences; Mr Subrata Sinha, National Brain Research Center and Mr PN Tandon, National Brain Research Center amongst others. The keynote speaker, Prof. Balling delivered a special lecture at the symposium on neurodegenerative diseases. ]]> <![CDATA[Innovative research is the key to progress, says President]]> https://biospectrumindia.com/news/95/6444/innovative-research-is-the-key-to-progress-says-president.html https://biospectrumindia.com/news/95/6444/innovative-research-is-the-key-to-progress-says-president.html Wed, 11 Mar 2015 11:40:25 +0530 The President of India, Mr Pranab Mukherjee inaugurated a week long 'Festival of Innovations' on March 7, 2015 at Rashtrapati Bhavan and gave away National Biennial Awards for Grassroots Innovations. The President also interacted with a new batch of Innovation Scholars In-Residence and Writers In-Residence. The festival will go on till March 13th. Speaking on the occasion, the President said Innovation is key to progress and prosperity. The process of innovation converts knowledge into social good and economic wealth. It encourages the engagement of talent with society to improve the quality of life. India has always had a strong tradition of knowledge. Our knowledge systems offer tremendous scope for research involving land-to-lab investigation and lab-to-land transfer of technology. It is important that the vast repository of indigenous knowledge is protected, documented, and preserved in active collaboration with prominent practitioners of traditional knowledge. Mr Mukherjee said India has the potential to be at the forefront of innovation. Encouraging steps in this direction notwithstanding, our country lags behind many others. India is ranked 76th in the Global Innovation Index 2014, much below China which is at the 29th position. Even Russia, at the 49th place and Brazil at 61, performed better than us. On the occasion, a total of 41 awards were given to 40 innovators and 6 communities. The President gave away 16 National, one lifetime achievement and one posthumous award. The President said, "Building viable linkages between formal and informal sectors also call for deepening the involvement of the leaders of technological, financial and educational sectors with the creativity of common people and young students. A Festival of Innovation has been started at the Rashtrapati Bhavan this year. It will help to provide a platform to bring different stakeholders together and make these entities active partners in inclusive innovation. The innovators participating in this program have come from various parts of our country. I hope that an empathetic value chain for disseminating good ideas can be built upon this initiative." After the award ceremony, the President also inaugurated the Innovation Exhibition at Rashtrapati Bhavan. This will remain open for the public till 13th March, 2015. ]]> <![CDATA[Hot Biotech Start-ups 2015: looking ahead]]> https://biospectrumindia.com/views/95/6420/hot-biotech-start-ups-2015-looking-ahead.html https://biospectrumindia.com/views/95/6420/hot-biotech-start-ups-2015-looking-ahead.html Wed, 11 Mar 2015 09:42:00 +0530 Dr M Kuppusamy, managing director, Tergene Biotech2014: Success, milestones and failuresYear 2014, was near standstill in terms of funding opportunities. The company tried its best to get PE funds/ Joint Ventures but in vain.The company successfully validated its indigenously developed platform technology for 15 valent Pneumococcal Conjugate Vaccine (PCV) in animal models.We were successful in the technology validation and scale-up of an affordable Pneumococcal Conjugate Vaccine (PCV) but failed to get visibility even with agencies like Gates foundation/ Wellcome Trust for Clinical Trial funding.Funding is available for the start-ups and you have more chances of receiving a fund up to the proof of concept stage. Thereafter, funding support for further development/ clinical trials is quite challenging.2015: The Road ahead/PlansWe are optimistic in bringing an equity/ JV partner to propel further into clinical validation phase. However, we are skeptical on the timelines in obtaining regulatory clearances for conducting CT. Dr Shrikumar Suryanarayan, chairman & co-founder, Sea6 Energy2014: Success, milestones and failuresLast year was good. We have made significant achievements. I cannot dwell too much information. We have certainly moved forward with our plans. Funding definitely is an issue, it also depends on how much time and energy, you are ready to give-in. Fund-raising is a long cycle, and we were fairly successful in raising funds for our company. I am hoping, the new budget will change these things and make an environment little conducive for start-ups. 2015: The Road ahead/PlansThis year we plan to broader our business and work towards achieving our objectives.Dr N Venkat, co-founder & CEO, Vyome Biosciences2014: Success, milestones and failuresIt has been very good. In 2014, we had major events. One was raising funding which happened in Aug'14. We have raised $8 million. The other major achievement was that we did very well with our Rx project with ANDA filing due in couple of months.We had also done well in commercializing one of our OTC anti-fungal product in India and most important thing is we have a build a new team, top management team, we have elected our new VP, ex-Australian R&D head of GSK, and also some new other, scientific advisors from the US to the board. All put together, it was a very eventful and progressive year.We have moved forward in terms of completing our initial steps.Except for some minor delays, here and there, no significant failures as such, we are very happy with our progress.2015: The Road ahead/Plans:The critical thing is we will continue to commercialise our couple of other OTC projects by own marketing as well as licensing. Also, getting into clinics trial for our Rx product, which has a very high validation standards in USA, post ANDA filing and also further build our top management level. Dr Abdur Rub, co-founder & CTO, XCode Life Sciences2014: Success, milestones and failures2014 was the best year so far for Xcode. We launched several new initiatives and made a lot of progress in our sales and marketing efforts. We ramped up our digital and offline marketing, corporate sales and international sales. We also initiated significant new product development activity in 2014.We kicked off our new product line 100&life which has already found a number of corporate customers in a short span. We have rolled out products to gyms and fitness chains as well. We successfully launched our flagship product 100&Life in international markets. ComeAlive, our beauty product gained significant traction across India.Through our different efforts we faced a number of challenges and learnt quite a bit. A key challenge was to develop a successful strategy to reach out to our target customer segment and communicate our value proposition effectively to them. We found that the medium and content of this communication with the customer is highly variable and dependent upon the target segment and value proposition of the product.We are on track to raise our series A funding soon. We are also scaling our operations in terms of research, customer support and marketing.2015: The Road ahead/PlansWe anticipate the progress we have made in 2014 will accelerate in 2015. We have new product launches lined up and look forward to serve our customers even better.Dr Ashwini Nangia, founder, Crystallin Research2014: Success, milestones and failures2014 was a good year in that we completed the BIG grant project on a novel first-in-class diabetic drugs pre-clinical study and also were awarded SBIRI funding for phase 2 studies in soluble curcumin compounds for cancer therapy. We expanded our clients' base to add more customers who use our R&D services in pharmaceutical solid state forms.The cell culture biology lab was consolidated and now all the company R&D labs are in the same location at the Technology Business Incubator, University of Hyderabad campus.One failure was that growth as compared to the previous year needs improvement and higher numbers are being targeted this year.Funding - Combination of CRO and Govt bodiesScaling - This is a limitation2015: The Road ahead/PlansThis year the focus is on completing the curcumin project and on building a network of new collaborators for work orders. Prof. Subrata Kumar Dey, founder, DSR Genome Technologies2014: Success, milestones and failuresIt was okay. Though it was not very profitable but it is running okay. Our main milestone is product development. We have developed a DNA isolation combo kit which is at the marketing level. It has also been used by some of the local institutions.Also, we developed a radio protective agent, which will provide radioprotection. A patent has been filed. We also provide training to students and services to companies, which also did well and we are concentrating on these at present.We have focused much more on R&D. We are developing some diagnostic kits, DNA isolation kits, and other kinds of kits required for laboratory purposes. For the types of kits we are developing, which are actually exports substitute also, if you develop indigenously it will cost less. Our main effort and focus is on the development of biotech products. We are looking to develop new products and also some of the existing products which our researchers currently import from foreign countries. Our products are at par with any conditional products.We are just three years old, and are maintaining a no-profit, no-loss. One problem that we are facing is fund requirement. If we get good funds, we can hire talented people which is the main shortage at this point. We are not getting adequate funds. 2015: The Road ahead/PlansThis year we are trying to raise funds. We are trying to get a Venture fund. We are also looking to expand our company, hire people and in the future, we wish to develop some more new products, because our main focus is the development of biotech products. Dr Birendranath Banerjee, managing director, inDNA Life Sciences2014: Success, milestones and failuresThe company increased its value by attracting investments and expanded the board. We have hired trained professionals and are expanding international collaborations.The first Quarter of 2014 began with a string of investment failures in terms of negotiations and VCs did not back our concepts. But by the second and third quarter, the company made up the lost ground and increased its investment portfolio.Funding is quite stable for the current year and the company plans to raise another round of funds in the second quarter of 2016. The scale up is an ongoing process and we are slowly expanding operations in lesser known important domains.2015: The Road ahead/PlansThe company has slowly transitioned from a Startup incubate to an operational corporate entity. Therefore, 2015 will be a year of consolidation and achieving operational targets set by investors and the board. Dr Mallik Sundaram, co-founder, president & CEO, Mitra Biotech2014: Success, milestones and failures2014 has been a year of growth across multiple fronts. On the R&D front, we expanded our product to newer classes of drugs like immunomodulators and biosimilars. Our research got accepted and published by some of the leading scientific journals like Nature, which is a great step forward. We entered the US market through collaboration with a leading chain of cancer hospitals. We have a presence through CLIA accredited lab in Chicago.We have seen an increased sample flow for CANScript service. The market response to the service has been good as it is one of its kind in India. We took on some key executives to strengthen our sales and marketing team. We have also been joined by some of the most experienced and effective leaders as scientific advisory board members.2015: The Road ahead/PlansOur plans for 2015 would be to scale up the service in a big way in India. Our aim is to make CANScript the preferred treatment selection enabler for oncologists. The US scale up is on the cards too. We plan to enter other emerging markets in 2015. Ms Anu Acharya, CEO, Mapmygenome2014: Success, milestones and failuresIt was great as we were able to get some of our channel partnerships in place, get some of our products out. We launched our first product genomepatri. Now that the products have matured a bit and our distribution is more or less in place, we are planning to scale the business. A startup has many failures. The first year and half we did a lot of experiments on our channel partners and distributors and then learnt what would work for us.2015: The Road ahead/PlansPlan to build our team and execute. ]]> <![CDATA[Suven Life Sciences secures two patents ]]> https://biospectrumindia.com/news/95/5075/suven-life-sciences-secures-two-patents-.html https://biospectrumindia.com/news/95/5075/suven-life-sciences-secures-two-patents-.html Tue, 10 Mar 2015 11:40:34 +0530 Suven Life Sciences has been granted a patent each by Eurasia and Israel for a drug used in the treatment of neuro-degenerative diseases. The company has been granted one product patent from Eurasia and one product patent from Israel corresponding to the New Chemical Entities (NCEs) for the for the treatment of disorders associated with neuro-degenerative diseases," the company said in a BSE filing. These patents are valid until 2029 and 2030 respectively. "We are very pleased by the grant of these patents to Suven for our pipeline of molecules in the CNS (central nervous system) arena that are being developed for major depressive disorder (MDD) with high unmet medical need with huge market potential globally," said Mr Venkat Jasti, CEO, Suven Life Sciences, in a statement. ]]> <![CDATA[Health minister inaugurates new center for vaccine management]]> https://biospectrumindia.com/news/95/6194/health-minister-inaugurates-new-center-for-vaccine-management.html https://biospectrumindia.com/news/95/6194/health-minister-inaugurates-new-center-for-vaccine-management.html Tue, 10 Mar 2015 10:40:48 +0530 On the occasion of the 38th annual day celebration of the National Institute of Health & Family Welfare on March 09, 2015, the health minister, Mr JP Nadda inaugurated the National Cold Chain and Vaccine Management Resource Center (NCCVMRC) and a Skill Lab at the Institute. The NCCVMRC will function as the nodal institution for supporting, facilitating and coordinating the cold chain and vaccine management functions of the Immunization Division of the Health Ministry. Whereas, the Skill Lab will provide training to improve the skills of healthcare providers and to enhance their capacity to provide quality RMNCH+A health services. Speaking on the occasion, Mr Nadda said, "While there is substantial amount of good work being carried out in various institutions under the Ministry of Health and Family Welfare, there is need to communicate this to the people. The people's representatives can be involved to carry the message of schemes offered by the government, best practices evolved and the work undertaken by the different institutions." The Health minister further mentioned that he is soon meeting various MPs to seek their suggestions and views on the implementation of Mission Indradhanush which the Health Ministry will shortly launch. The Mission Indradhanush aims to cover all those children who are either unvaccinated, or are partially vaccinated against seven vaccine preventable diseases which include diphtheria, whooping cough, tetanus, polio, tuberculosis, measles, and hepatitis B. He informed that a Mission Mode has been adopted to achieve target of full immunization coverage by 2020. Pointing out that health is a subject which is significantly influenced by various socio-economic determinants, health minister urged the faculty and staff at the Institute to think in a holistic manner while conducting research, and evaluation or monitoring of schemes. Convergence of knowledge from diverse sectors will make the research and monitoring outcomes rounded and more realistic, he stated. While one can always learn from best practises around the world, the Health Minister encouraged the faculty and staff at the NIHFW to contribute to the emerging best practises in the health sector. He urged them to be attentive to the quality of research, training and other services that provide to the various healthcare providers across the country. ]]> <![CDATA[India gets its magical vaccine, PM Modi calls it a great achievement]]> https://biospectrumindia.com/news/95/7271/india-gets-its-magical-vaccine-pm-modi-calls-it-a-great-achievement.html https://biospectrumindia.com/news/95/7271/india-gets-its-magical-vaccine-pm-modi-calls-it-a-great-achievement.html Tue, 10 Mar 2015 10:37:44 +0530 Each year, diarrhoea caused by rotavirus results in 10 lakh hospitalizations and kills nearly 80 thousand children under the age of 5 years. Besides causing emotional stress to the affected families, it also pushes many Indian families below the poverty line and also imposes significant economic burden on the country. But now India has realized its dream of developing an indigenous vaccine against the rotavirus, the main cause behind diarrhoea. Developed by Bharat Biotech, the oral rotavirus vaccine, ROTAVAC is safe and effective in preventing rotavirus diarrhoea. While launching the made in India vaccine, the Prime Minister Narendra Modi felicitated all the partners in the development of the first indigenous rotavirus vaccine, which involved the complete cycle from basic research to product development of this advanced vaccine in India. This announcement fulfilled Bharat Biotech's promise of a $1/ dose vaccine to governments in low income countries. The company has recieved commercial licensure and the vaccine is safe to use. PM also lauded this initiative as an example of India`s capabilities for high-end research and development; manufacture of sophisticated pharmaceutical products in India; and, effective Public-Private-Partnership model for finding affordable solutions to societal challenges. The Prime Minister remarked that India is characterized by large size and diversity; and continues to face a number of socio-economic challenges. He hoped that the development of the rotavirus vaccine would inspire higher levels of research, development and manufacturing activities in India, not just in medical science, but also in other advanced areas of science and technology. The Prime Minister felt that solutions found in India would have great relevance to the rest of the world, especially the developing world. The vaccine has been developed under an innovative public-private partnership model. It involved partnership between the Ministry of Science and Technology, the institutions of the US Government, various government institutions and NGOs in India, supported by the Bill and Melinda Gates Foundation. Funding by government of India supported basic research in educational and scientific institutions in India. This was also supplemented by the support of the US Government institutions like the National Institute of Health. The Gates Foundation and Bharat Biotech India Limited contributed towards product development and testing. The successful launch of the first indigenously developed and produced vaccine today was the result of an extraordinary effort spread over the last 25 years. The Bharat Biotech India that was involved in the development and production of the vaccine was selected in 1997-1998 by the India-US Vaccine Action Program and the standard government procedures. The company has been given undertaken to keep the cost of the vaccine at $ 1 per dose. This is the third such vaccine available globally against Rotavirus and, at the current prices, the cheapest. Union Ministers, Mr Venkaiah Naidu, Mr JP Nadda and Mr Harsh Vardhan were present on the occasion. ]]> <![CDATA[Hot Biotech Start-ups: Theramyt Novobiologics]]> https://biospectrumindia.com/views/95/6202/hot-biotech-start-ups-theramyt-novobiologics.html https://biospectrumindia.com/views/95/6202/hot-biotech-start-ups-theramyt-novobiologics.html Tue, 10 Mar 2015 09:31:00 +0530 Ms Kavitha Iyer Rodrigues, director and COO, Theramyt Novobiologics2014: Success, milestones and failures2014 was a very successful year for us. Our labs started operating to full capacity and our technical team is complete. This has resulted in reaching our technology milestones for the year ahead of time.Our most critical assets are the two technology platforms - Fucose Knockout Cell line and Yeast Display Library. We achieved both these platforms within 80 percent of our budget and with 2 months to spare.Another important milestone is the SBIRI grant we received for one of the novel expression strategies we are experimenting with for one of the existing biological drugs. One of our failures, probably, was to estimate the clearance time taken by FIPB to approve FDI in to biotech industries. This has pushed back our plans by close to 6 months. We started our lab work from July of 2013 instead of December of 2012.Setting up a biological R&D company in India is not easy. We have been fortunate to get substantial funding at the very inception stage of the company. That too from investors who bring a lot of value and patience required for our kind of industry. Biological drug development not only involves high capital infusion but also long incubation time. Not only our venture capital investors but also 2 grants from BIRAC-BIG and SBIRI have been extremely supportive to allow us to focus on our science. The 3 stages of funding- BIG, SBIRI and BIPP are very well designed to match the development and maturity of a biotech project.While the funding schemes by the DBT are encouraging and supportive, some of the policies, especially with respect to DSIR certification is counter-productive and discouraging. We have not been able to receive a DSIR approval for our R&D labs to avail import duty exemptions for our lab equipments. A new company needs such SOP at the beginning of its lifecycle and not after 3 years of existence. So we have ended up spending 30 percent more in procuring equipments, most of which are imported. 2015: The Road ahead/Plans:Our major plans for 2015 are: File global patents for the provisional patents we have filed in 2014, aggressively pursue business development in the US, EU and Japan and close our Series B funding. ]]> <![CDATA[FDA approves first biosimilar Novartis's Zarxio]]> https://biospectrumindia.com/news/95/6150/fda-approves-first-biosimilar-novartiss-zarxio.html https://biospectrumindia.com/news/95/6150/fda-approves-first-biosimilar-novartiss-zarxio.html Mon, 09 Mar 2015 12:47:31 +0530 Sandoz, a Novartis company, has announced that the US Food and Drug Administration (US FDA) has approved Zarxio (filgrastim-sndz) for all indications included in the reference product's label. Sandoz is the first company to receive approval of a biosimilar in the US through the new FDA biosimilars pathway established under the Biologics Price Competition and Innovation Act. The approval was based on a comprehensive package of analytical, nonclinical, and clinical data, which confirmed that Zarxio is highly similar to the US-licensed reference product. The approval of Zarxio follows the unanimous positive vote in January by the Oncologic Drugs Advisory Committee (ODAC). "The FDA approval of Zarxio marks a significant milestone for the United States healthcare system and for patients who might suffer from neutropenia," said Ms Carol Lynch, global head of biopharmaceuticals and oncology injectables at Sandoz. She added, "As the global leader in biosimilars, we are honored to be the first company to successfully work with FDA to navigate the US biosimilar pathway and we look forward to making this high-quality biosimilar available to patients in the US." Marketed as Zarzio outside of the US, the Sandoz biosimilar filgrastim is available in more than 60 countries worldwide, has generated over 7.5 million patient-days of exposure. ]]> <![CDATA[AbbVie's acquisition of Pharmacyclics alleviates dependency on Humira?]]> https://biospectrumindia.com/features/95/5701/abbvies-acquisition-of-pharmacyclics-alleviates-dependency-on-humira.html https://biospectrumindia.com/features/95/5701/abbvies-acquisition-of-pharmacyclics-alleviates-dependency-on-humira.html Mon, 09 Mar 2015 12:05:45 +0530 "This is a major step for AbbVie following the terminated Shire deal, as the rest of AbbVie's business is faltering. The company's pharmaceutical revenues, excluding Humira, shrank by $467 million last year," said Mr Joshua Owide, GlobalData's director of healthcare industry dynamics. "To compound this, the threat of Humira biosimilars is looming ever nearer, with Amgen, Boehringer Ingelheim, Pfizer, Fujifilm Kyowa Kirin Biologics, Sandoz and Samsung all in late-stage clinical development with their respective adalimumab biosimilars. These are expected to have a major impact on Humira sales following its anticipated 2018 US patent expiration," he explained. However, PCYC's lead product Imbruvica (ibrutinib) will bring in revenue of more than $40 billion over 15 years and clinical pipeline assets include abexinostat, in development for multiple cancer types, PCI-27483, for pancreatic cancer, and BTK inhibitors, to treat autoimmune disorders. "There is notable synergy with AbbVie's oncology pipeline, as three compounds in PCYC's late-stage development are expected to generate peak annual revenues of more than $3 billion," he added. As such, the deal will secure AbbVie the status of having the eighth most valuable oncology portfolio, with a net present value of $30 billion, up from eighteenth based on pre-PCYC acquisition estimates. ]]> <![CDATA[Sun Pharma recalls eye drug in the US]]> https://biospectrumindia.com/news/95/6166/sun-pharma-recalls-eye-drug-in-the-us.html https://biospectrumindia.com/news/95/6166/sun-pharma-recalls-eye-drug-in-the-us.html Mon, 09 Mar 2015 12:04:42 +0530 Sun Pharma has decide to recall 5,322 bottles of Ketorolac Tromethamine ophthalmic solution in the US market for failing to meet specifications. The ophthalmic solution falls under non-steroidal anti-inflammatory drug (NSAID) category and is indicated for relief from pain and inflammation in the eyes. The company is recalling the drug for the presence of particulate matter in the 5,322 batch of bottles. The drug was manufactured by the company's Halol facility in Gujarat. It has been classified as a Class-II recall which FDA defined as "a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote". ]]> <![CDATA[Hot Biotech Start-ups: QTLomics Technologies]]> https://biospectrumindia.com/views/95/8341/hot-biotech-start-ups-qtlomics-technologies.html https://biospectrumindia.com/views/95/8341/hot-biotech-start-ups-qtlomics-technologies.html Mon, 09 Mar 2015 11:27:00 +0530 Dr Krishna Prasad, COO, QTLomics Technologies2014: Success, milestones and failures2014 was not bad. We have hired few people in our team and also acquired space to begin our operations. With what started as a team of 3 people, we are now 13 people and we have grown in all directions.One significant thing is we are on the verge of break-even the investment. The amount of investments that we had and the turn-over that we could made, we have just crossed the break-even point. That is the major highlight. Start-ups, in the first two years generally don't make any profit, you can't accept profits. If you can break even that is a big achievement. That I would say is our biggest achievements for a start-up, to be profitable in the first year.I would not say failures, it is just learning process, some projects we could not deliver because of prize issue, not an important thing but still it affects because of that we could not complete few projects, basically we did not get those projects, otherwise we would have made even better than what we are today.I think in the coming years a lot of people will be investing in agriculture, which have taken a back seat as of now. We are very fortunate enough to have customers outside of India, now QTLomics is known to everybody as far as branding is concerned. We have rightly branded our self as an agri-genomics company.2015: The Road ahead/Plans2015, we will raise funding, we are looking for another Rs 2 crore, so that we can develop products. Last year, we were providing services, we were taking and selling the products basically to enter the markets. We are slowly moving into developing the product. We have initiated our R&D efforts for our two products, which we would like to come up with this year. In order to raise more value both in terms of the number and value for the customers, it is always good to make your own products. So, this year we would love to bring out at least two products. ]]> <![CDATA[Revolutionizing medical diagnosis through genetic screening]]> https://biospectrumindia.com/features/95/4133/revolutionizing-medical-diagnosis-through-genetic-screening.html https://biospectrumindia.com/features/95/4133/revolutionizing-medical-diagnosis-through-genetic-screening.html Sun, 08 Mar 2015 09:48:00 +0530 Mumbai-based Navigene was incorporated in April 2012 and began operations in Nov 2012. The company operates in the domain of genetic science undertaking screening, diagnosis and research in Metabolomics with focus on non-invasive Preventive Testing (New Born Genetic Screening (NBS), Metabolic fingerprinting, Prenatal screening etc). It is said to be the first institution to have developed a robust Preventive Genetic Screening solution which is implementable at a large scale.Dr Rishi Dixit, MD and CEO and Dr Vrushali Joshi, CTO, co-founded Navigene along with Incucapital. "Our aim is to strive for early and accurate prediction of diagnosis of disorders and ailments, through Preventive Genetic Screening solution across age groups and give an individual a head start in managing his/her health. The challenge is to make such preventive health screening mass marketable and at affordable price," said Dr Dixit.The company currently offers Newborn Screening and Diagnostics, Metabolic testing for Adults, Prenatal Screening and Diagnostics, Cytogenetics, Molecular diagnostics and Genetic counseling.It's flagship product Navigene Baby Screen, is innovative and unique technology, that screens the New born babies for 110 genetic and metabolic disorders as early as 3rd day of life through just a urine sample collected on a special filter paper. Traditionally, NBS across world is done through blood samples. It is one of the most comprehensive screening tests in the world, according to the company. It offers one step confirmatory (for 80 percent of disorders screened) making a follow up test unnecessary. "The newborn screening portfolio at Navigene starts from 3 basic disorders moves up to max 110 disorders. We have screening packages to suit every budget from High end corporate hospitals in metros to the nursing homes in tier 2 and 3 cities," informed Dr Dixit.The company was funded through seed capital raised with the help of Institutional co-promoters Incucapital. "We are planning to raise series a funding in next 6-8 month," notified Dr Dixit. It has currently partnered with Cordlife India, a Stem cell bank for new born screening and Metabolic fingerprinting services, whereby they would be offering its services to their clients. Talking about the challenges that they faced while establishing Navigene he said, "Acceptability to new technologies is a hurdle we faced when we started but we were successfully able to prove ourselves with the kind of results we have given to our clients." He added, "Awareness amongst the prospective clients is the biggest challenge. Patient education is virtually non-existent in India. Reaching the clients another challenge as the cost of reaching the client in this industry is huge. We are adopting innovative ways such as online registrations for the test to overcome the challenges and have tasted some success with our methods."Most of the system/machines/hardware/reagents etc we currently use are imported, the kind of duties levied on these seems to be very steep and at times affects the viability of the entire project. The manufactures along with the demand from the smaller companies have come up with some innovative ways such as reagent rental models etc, but I feel the Govt can do good to relook at these duties and extend some sector specific sops that should benefit start up. Unless this happens the Make in India would be a distant dream. I feel it's one of the best times to be an entrepreneur across various countries globally. The company is further looking to break through preventive screening product around metabolomics in area of oral and breast cancer as well as adult metabolic dysfunctions and is also looking to further improve the current product mix on the Newborn screening to include Sickle cell, Thalassemia and other important genetic disorders screening. Dr Dixit elaborated, "One such test is called metabolic fingerprinting. This is a service for Adults which is about to be launched is also a non-invasive simple to do test which requires a urine sample absorbed on the special filter paper provided. This is known as Metabolic fingerprinting or Metabolic profiling, and is an advanced diagnostic procedure that reveals the root causes of health conditions or diseased states and recommend steps to manage the same."The test analyses the presence/absence or levels of certain metabolites/biochemical markers which are by products of metabolism in your body and can forewarn you about certain impending diseases. These markers when studied by the Metabolic Profiling test can tell you about the required changes in the way you live and what you eat to ensure an improvement in the health conditions and reduction in disease risk. Using test results, practitioners can design comprehensive, customized therapies to restore optimal metabolic health.In terms of marketing and sales, the company plans to expand its presence to 25 more cities in next one year in India and reach out to the client in Middle East, South East Asia and Europe through partnerships. "We look forward to work with the Government Hospitals and NICU across India as these are the hospitals where a lot of such cases at first instance get referred to and we can still help them," he signed off. ]]> <![CDATA[Medical textiles may soon solve Indian healthcare woes]]> https://biospectrumindia.com/features/95/5489/medical-textiles-may-soon-solve-indian-healthcare-woes.html https://biospectrumindia.com/features/95/5489/medical-textiles-may-soon-solve-indian-healthcare-woes.html Sat, 07 Mar 2015 09:21:00 +0530 Located in Tirupur, India, Shakti Knitting is one of the top ranked export hub for knitted garments across the globe. After tasting success with fashion and design, the founders of Shakti Knitting, were yearning to diversify. As healthcare offered an option to both innovate and grow, the founders chose medical devices as the key area of focus and quickly formed a subsidiary, SKL Medtech. The start-up aims to provide novel healthcare solutions through medical and protective textiles. "Growing antibiotic resistance is a global issue," said Mr Vasanth Kumar, co-founder, SKL Medtech, "Both CDC and WHO have rung alarm bells that antibiotic resistance is the biggest emerging threat to mankind. As engineers we are looking at textile-based solutions to address this issue. Utilizing our cross platform technology, we have developed two products- Theruptor, which is drug free active wound care system and Krida, which is a light weight, flexible and sterile X-Ray attenuating apparel that protects from radiation exposure to health care providers." Theruptor facilitates wound healing without the use of any antimicrobial drug. It acts as a barrier against airborne pathogens, as well as sanitizes the wound by actively killing germs. The three dimensional structure of Theruptor enables oxygenation of the wound without allowing airborne particulates and microbes to enter the wound. The mechanism also removes the exudates continuously and evaporates it. Theruptor finds an important application in wound dressing and can be applied on wounds such as burns, diabetic, venous ulcers, trauma, incisions and skin graft and donor site. "There are many issues in the traditional and advanced wound care methods currently followed, said Mr Kumar. These methods prevent oxygenation of the wound and allow pathogen to proliferate on the dressing thus giving rise to resistant bugs." Co-founded by four like-minded individuals, SKL Medtech is being incubated/accelerated by Escape Velocity Accelerator. "The advanced wound care market is expected to swell to almost $8bn by 2017," said Mr Vasanth Kumar, "we at SKL discovered this market trend and have embarked on our mission to develop unique medical devices that can in a way, transform healthcare in India. Antimicrobial dressings are one of the fastest growing market segment in advanced wound care. Theruptor's addressable market includes the antimicrobial/moist sectors that make up a total $2.5bn opportunity." Apart from Theruptor, another disruptive medical technology developed by the company is Krida that has the potential to replace lead based aprons in X-ray rooms. Explaining this unique device, Mr Kumar said, "Scattering of X-rays and eventual absorption of radiation by human body is a hazardous problem. The heavy weight of lead aprons currently used, causes discomfort to healthcare providers while performing procedures. Moreover, the aprons are not flexible and do not offer complete coverage of the body. The soiled aprons, after procedures are not easily autoclaveable. Krida is light weight, sterile and provides complete coverage of the body." Krida provides protection for healthcare providers in the procedure room involving radiographs. The product can also used as curtains at ICUs where portable X-ray units create a lot of scattering and exposure to nearby patients. Theruptor has fared well in animal trials and has demonstrated a 40 percent faster healing capability when applied to surgical and infected animal wounds. Confident that the new technology will create waves in the market, Mr Kumar observed, "Since there are no legally marketed predicate device cleared by the US FDA, our application in the De Novo route is being prepared and is expected to be submitted by end of this year. Our discussions with FDA representatives indicate that our applications could be moved over to Class II device following a 510 K premarket notification approval process. The approval process will take about 6 to 9 months. On successfully clearing the evaluation, we would be free to market the product with US FDA clearance."SKL Medtech has filed for the complete patent application and PCT covering the Treaty countries. Following approval, the company is planning for a national filing for individual country such as US, UK, Europe and Japan. The company expects that the patent for the product will be granted within a year.Krida being a disruptive technology, is set to replace the Lead Aprons and has no direct competition in its space. In the US alone, 1.5 million surgeries are being carried out using imaging techniques. "Our estimation based on a team of 4 health care givers assisting per surgery leads to a requirement of 72 million units per year on 6 month replacement cycle," added Mr Kumar.With increased life expectancy, ageing society, evolving infections, there is a growing demand for treating diseases. The researchers' perspective towards curing and preventing ailments is changing fast with microbes developing drug resistance. Few years ago, it would have been tough to find manufacturing companies in India, embarking on the path of healthcare. However, the scenario is changing fast and nowadays healthcare and medical devices have caught the imagination of young entrepreneurs, who are designing novel products to revolutionize healthcare, in an attempt to grab a considerable portion of the market share. Currently India does not have a major presence in the medical device market and many of the devices used in the country are imported. Rural India is a big market for any entrepreneur as it has remained untapped so far. A proper regulatory body for medical devices can help in nurturing. However, a big breakthrough that can foster the Indian medical devices industry would be bringing about a robust and efficient regulatory body. ]]> <![CDATA[ â€œGovt has been tardy in spending on healthâ€?]]> https://biospectrumindia.com/interviews/95/7673/-govt-has-been-tardy-in-spending-on-health.html https://biospectrumindia.com/interviews/95/7673/-govt-has-been-tardy-in-spending-on-health.html Sat, 07 Mar 2015 09:01:00 +0530 Q: Please tell us about the current efforts for the eradication of Leprosy from the country?When I joined the Central Drug Research Institute (CDRI), Lucknow way back in 1950, I started working on Dapsone as it was coming out as a promising drug. We started making its analogs and improved key activities. However, the pharmacoeconomics which was the comparison with available therapy couldn't be approved. We worked on the design and synthesis of sulphones and sulphonamides for leprosy. We tried to understand crucial factors in drug design such as transport across membranes, biology of the parasite and pathology of the disease through a multidisciplinary approach. The drug development studies of the candidate molecules included a study of their absorption, metabolism and distribution even at that early stage. Diaminodiphenyl sulfone (DDS) was very cheap and easy to use. We also had a drug that was made active but it was not cheaper than DDS which had favourable pharmacoeconomics. Q: Has there been any change in the social stigma attached with Leprosy?The social stigma still exists but at a very low scale. In 1983, as a member of the then Prime Minister's committee for health, I remember that even patients had to take special permission to travel. Finally after hectic efforts, it was changed and the discrimination removed. However, in rural areas, they are treated as outcasts. Like any other disease, they have to be treated and we have to build awareness on the subject. Q: What has been the recent research for treatment of this disease?With a multidrug treatment (MDT), what they call, Dapsone as a basic drug can be combined with others such as rifampicine and clofazimine, ninety nine percent of cases can be treated. This is a part of the government program and available for free. Dapsone has less resistance and has been the effective treatment whose use within a MDT can help eradicate the disease. Q: Has there been any national mission to tackle the disease? What is required?There indeed was a mission in place in year 2000 and was extended up to year 2005 later as the targets were not completed. Now, it is the duty of the government to rework on it and complete it with new targets. There is no mention of it in the national health policy draft. It must be included as well. Diagnosis is not easy and there is requirement of well-trained people who have trained hands for treating leprosy. When it becomes a part of the mission program, specific efforts unfortunately are watered down. Lack of efforts in diagnostics for Leprosy need to be taken care of.Q: Which disease areas according to you must be prioritized? The diseases that require attention are Malaria, Tuberculosis, and Leprosy in infectious disease category.Leprosy drugs are available with the government machinery and awareness has to be built in a large scale. Very serious research work has been done on malarial vaccines. But the results are yet to be seen on ground. It is a very serious concern. In tuberculosis, resistance is a big problem. They have drugs but the development of resistance is an issue. Today in India, there is growing resistance as we have not taken care at the appropriate time. There are varieties which are not responding to available drugs and are thus much more infectious. If a vaccine could be developed at an appropriate time, virulence could be stopped.Q: What is required by the government on the lesser health spending?Government is very tardy in spending on education and health. I can say that without any question as these two areas have been ignored repeatedly. There could have been much more done for these areas but unfortunately despite marketing of policies by the respective governments, there has been much less happening actually. At least, there can be 2 to 3 percent of GDP spending for actual results to come. That would be far lesser but could make a difference. ]]> <![CDATA[Sakra, Dabur to provide healthcare services]]> https://biospectrumindia.com/news/95/5003/sakra-dabur-to-provide-healthcare-services.html https://biospectrumindia.com/news/95/5003/sakra-dabur-to-provide-healthcare-services.html Fri, 06 Mar 2015 12:22:34 +0530 Sakra World Hospital has joined hands with Dabur Group to support its initiative HealthCare At Home (HCAH). It will now offer personalised care at patient's home, by trained healthcare professionals helping them in saving time, travel and also providing greater convenience to them and their families. Sakra HCAH services will include laboratory investigations and home visits of doctors, nurses, nutritionists, physiotherapists. Sakra HCAH will not only provide value to the patients post-discharge, but also to anyone who needs healthcare assistance at home due to any type of medical concern. "We believe in giving complete care to the patients, including care beyond hospital, so that patients can have healthier, happier and hassle-free life," said Dr Raajiv Singhal, Group CEO, Sakra World Hospital, in a statement. "This partnership with Sakra will act as a game changer in the treatment, offerings & standards in the home healthcare services in Bangalore at large. With well-equipped infrastructure, trained resources and technology platforms we will ensure patient care in the comfort of your home," says, Dr Gareth Jones, chairman, Health Care at Home, India. ]]> <![CDATA[Eisai and Merck collaborate for cancer cure]]> https://biospectrumindia.com/news/95/7409/eisai-and-merck-collaborate-for-cancer-cure.html https://biospectrumindia.com/news/95/7409/eisai-and-merck-collaborate-for-cancer-cure.html Fri, 06 Mar 2015 12:18:19 +0530 Eisai and Merck has announced a clinical trial collaboration. The deal is to evaluate the safety, tolerability and efficacy of Merck's anti-PD-1 therapy, pembrolizumab (marketed in the US under the brand name KEYTRUDA), in combination with Eisai oncology compounds lenvatinib mesylate (a multi-targeting RTK inhibitor marketed in the US under the brand name LENVIMA, "lenvatinib") and eribulin mesylate (a microtubule dynamics inhibitor marketed in nearly 60 countries HALAVEN, "eribulin") in multiple clinical trials. The planned studies include a multicenter, open-label Phase 1b/2 study of lenvatinib plus pembrolizumab in select solid tumors and an open-label, single-arm, multicenter Phase 1b/2 study to evaluate the efficacy and safety of eribulin in combination with pembrolizumab in metastatic triple-negative breast cancer. Eisai and Merck will establish a Joint Development Committee to oversee clinical development activities. "This collaboration could be a major step in the direction of developing combination regimens in different types of cancer, potentially maximizing the value of eribulin and lenvatinib," said Dr Kenichi Nomoto, president, oncology product creation unit, Eisai Product Creation Systems. He added, "Together, Eisai and Merck seek to explore combination regimens that have the potential to create synergistic effects between lenvatinib and pembrolizumab as well as between eribulin and pembrolizumab. Our hope is that we will bring treatments to market that make a difference in the lives of people battling cancer." "Cancer is a complex disease that often requires different approaches to help patients achieve the best possible outcome. The collaboration with Eisai exemplifies Merck's focus on advancing breakthrough science in immuno-oncology. We look forward to evaluating pembrolizumab in combination with eribulin and also with lenvatinib in different tumor types," said Dr Eric Rubin, therapeutic area head, oncology early-stage development, Merck Research Laboratories. The studies are expected to begin in the second half of 2015. Financial terms of the agreement were not disclosed. ]]> <![CDATA[Hot Biotech Start-ups: A year later]]> https://biospectrumindia.com/views/95/7620/hot-biotech-start-ups-a-year-later.html https://biospectrumindia.com/views/95/7620/hot-biotech-start-ups-a-year-later.html Fri, 06 Mar 2015 09:46:00 +0530 Some transitioned from an incubatee to an independent corporate identity. While others launched their products in the market. Some like Mitra Biotech were also successful in entering overseas market.Funding remained a critical part for all these start-ups with almost all of them were successful in raising funding both from VCs and public organisations. Few companies like Theramyt and Crystalin were also successful in receiving BIRAC-BIG and SBIRI grant. Another important event for these start-ups was expanding their team, with star-ups like Vyome biosciences, QTLomics, MedGenome etc appointed new members to its management team. Collaborations was another important step for these start-ups, with many of these, tying up with other firms both in India and globally. All in all, these start-ups were successful in completing initial steps and are working towards scaling their operations both in research as well as marketing. Read on to find out more. Edited Excerpts: Mr Sam Santhosh, CEO, MedGenome2014: Success, milestones and failures2014 was a busy year for MedGenome. We have built our hospital collaborations further in 2014 wherein we engage with institutions to provide solutions that cater to patients visiting hospitals. We have also expanded our gene panel offerings to cover major disease areas such as Oncology, cardiology, ophthalmology, neurology, and nephrology. MedGenome's proprietary cancer analytics platform, OncoMD, has been expanded with newer features and applications for both diagnostics and research. We have been in discussions with multiple clients globally to offer this platform both as standalone installation and as a software-as-a-service license. MedGenome's capabilities and services are also finding attention among genome researchers who want to partner for exploratory research and drug development.Some of the key milestones were that we expanded our presence to Pan-India, offering end-to-end integrated solutions for clinical diagnostics. We opened up our new office in Gurgaon and expanded our lab operations in Bangalore. We have started our proteomics facility with our collaborators in Narayana health city in Bangalore, complementing our Next Generation Sequencing (NGS) lab facility at the same premises. We have also designed a new offering named Integrated Genomic Platform (IGP) to cater to the genomic research requirements of pharmaceutical, academic and biotechnology firms.We were also happy to initiate a partnership with a US technology company to bring the non-invasive prenatal test to India.We have been on target with what we had planned for 2014. In fact, our 2015 plans will be more aggressive because of the traction that we have received in the market - both in India as well as globally. We raised first round of funds in 2013 which we used to increase our presence pan-India as well as develop new gene panels for key disease areas. We expanded our lab operations in Bangalore as well. We will raise our second round to focus on our research projects by setting up genomic research centers across India with our collaborators and also expanding our reach globally.2015: The Road ahead/PlansThe goal is to continue to offer services and solutions to the healthcare market in a customized manner. We will continue to strengthen our presence in clinical diagnostics in India. We want to continue to collaborate with major hospitals and academic institutions in India. We are growing our software and bioinformatics team. Deriving meaningful insights from genomic data is a challenge. We have developed proprietary tools and analytics to convert this data into useful insights and want to continue to scale it up. This is considering the fact that our sample volumes are increasing with our Bangalore lab facility expanding. Our recruiting team will be very busy in the coming year! We are seeing lots of traction for our bioinformatics solutions from global players as well, which is something we will plan for.Another area for genomics application is Prenatal Testing (NIPT) where the impact can be very high. It is estimated that genetic/chromosomal abnormalities occur in about 1 of 200 live births and account for at least half of all miscarriages that occur during the 1st trimester. Genomics can provided a much needed option for parents who are in need. In the coming year, MedGenome would develop capabilities to introduce safe, comprehensive and highly accurate non-invasive prenatal testing to Indian population. Unlike the traditional genetic testing like amniocentesis, non-invasive tests causes no risk to the fetus, which makes us very excited about such technology.We will also be setting up close to 25 genomic research centers across the country with our collaborators. The idea is to encourage research based on genomics and derive meaningful insights for both academic and commercial purposes. ]]> <![CDATA[Debate continues on GM technology]]> https://biospectrumindia.com/features/95/6737/debate-continues-on-gm-technology.html https://biospectrumindia.com/features/95/6737/debate-continues-on-gm-technology.html Fri, 06 Mar 2015 09:38:00 +0530 During 2013-14, India cultivated a record 11.6 million hectares of Bt cotton, planted by 7.7 million small farmers with an adoption rate of 95 percent, up from 11 million hectares in 2013, said the International Service for the Acquisition of Agro-biotech Applications (ISAAA) report released on January 30, 2015. Notably, the increase from 50,000 hectares of Bt cotton in 2002 (when Bt cotton was first commercialized) represents an unprecedented 230-fold increase in thirteen years. British economists Brookes and Barfoot estimate that India's farm income from Bt cotton enhanced by $2.1 billion in 2013 alone. "The accumulated hectares of biotech crops grown in 1996 to 2014 equals, roughly, 80 percent more than the total land mass of China," said Mr Clive James, ISAAA founder and report author. "Global hectarage has increased more than 100-fold since the first planting of biotech crops," he added in a video telecast during a press briefing held in New Delhi."The world is moving forward in adopting GM crops. There is a new momentum, new hope that India must realize to harness the benefits of this useful technology," said Dr CD Mayee, president, Indian Society for Cotton improvement. "It is high time we catch up with others in extending the technology beyond Bt cotton," he added. Bt cotton now occupies 95 percent of the produce in India Once banned and then legalized, genetically modified cotton in more than one decade has been able to cover most of the cotton cultivating belt in India, thereby replacing the traditionally grown varieties. While regulatory authorities approved three hybrids in 2001, more than 700 types of Bt cotton seeds are now available in the Indian market. Over a 13 year period, India tripled its cotton production from 13 million bales to 40 million bales in 2014 and is projected to overtake China to become the number one cotton producing country in the near future. As per Dr CD Mayee, India has to break the impasse in GM crops as the current scenario cannot go on for long. "The success of Bt cotton must be an eye opener for those who oppose the cultivation of genetically modified and do rumour mongering. He further added, "I am hopeful that government will take positive steps to bring back confidence of scientists." Dr Mayee was also the former chairman of Agriculture Scientist Recruitment Board. Talking about the future of technology, Mr Bhagirath Choudhary, director (India), ISAAA, said, "Development and deployment of high-density planting to maximise yield potential, popularising the system, and mechanization of cotton picking and harvesting is the way forward for Bt cotton in India. In the high-density planting system (HDPS), scientists intend to plant 1-2 lakh cotton plants in the same hectare of land. The spacing between two plants could be as low as 20 cm, instead of 90 cm-1 m for conventional cotton."Side effects of uncertainty Besides creating a negative image in the public psyche about the technology, the ongoing debate has led to an impact on education and skill development. "Genetic engineering has been demonized due to the controversy. Youngsters are feeling scared to take it as a subject due to the lack of long term prospects," said Dr Deepak Pental, former vice chancellor of Delhi University, adding further, "If you speak to young biotech graduates, nobody is interested as they don't want to get caught in an unpredictable situation and ruin their career."GM technology is not only about Bt Cotton or Bt Brinjal. It has much more to offer. According to Mr Ram Kaundinya, director general, Association of Biotechnology Led Enterprises-Agriculture Group (ABLE-AG), "There are many GM traits available to help tackle drought, salinity, high fertiliser usage, improving agriculture productivity and so on. The country will face shortage of pulses and oilseeds in the next 10-15 years as we try to meet our changing food habits."In the report "GM Crops: Perception vs Reality", co-author Dr TM Manjunath, prominent agri-expert, trashes the theory that genetic engineering in plants is against nature. "Genetic exchange between organisms has been taking place in nature since millions of years and along with mutations, is the basis of evolution. However, this process takes a long time, tens of thousands of years. The genes are transferable and during GE, it is accomplished in a highly scientific and precise manner," he wrote.Debunking theories that farmer suicides are happening due to Bt cotton, Mr Vijay Atmaram Ingle, a farmer from Akola, Maharashtra, mentioned that it is the money lenders and domestic issues which are the real reason for suicides. "All of us in Vidharbha grow Bt cotton. We can't grow cotton without Bt technology. For us to gain profits and earn income for our family, we need a new set of seeds to help us control weeds, withstand drought and increase cotton yield to the next level," he said. Charging the activists for turning science into a political battlefield, Dr Shanthu Shantharam, visiting professor, Iowa University, believes that the opposition sounds more political than based on facts. "While outside they say they are against technology in all forms, in court, they say that they are not against research," said Dr Shantharam who feels that there is a parallel science to confuse people. "These parallel scientists who have degrees but no will to defend research, are maligning biotech crop research. There is no chemical or substance in these products that can cause any problem in the longer run. Have been consuming may GM products outside but nothing happened to me," he lamented. Reminder to government on decisive policy "It is hysterical that even confined trials are not being allowed. If government funds a project worth crores and withdraws product approval, then it makes no sense in supporting it in the first instance," mentioned Dr Deepak Pental who feels that activists should also study the effects of pesticide usage and rather pursue other grave health issues such as chewing of tobacco and ghutkha."Prosperity of India depends on the prosperity of the Indian farmers. It is important to note that 47 percent of Indian population is still dependent on agriculture (small holding farmers). It is calculated that it will still be at 42 percent by 2032. While it is claimed that enough allocations are made for agriculture, the truth is that 95 percent of funds go into salaries and not in actual research," added Dr Pental. As per Dr Shanthram, complete politicization has happened in India since Jairam Ramesh put a moratorium on it. He said, "Policy can't be decided on the streets. Although the government has been positive, outcome is yet to be seen. There is what I call a 'muti-million protest industry' thriving on the issue. Technology has been held hostage."And there are comparisons as well. "Canada is an example as it is one country which is not aggressive like the US is alleged to be. But it has got 7.7 million hectares under GM crop cultivation. We either follow Europe or Japan and be among GM importing nations or like Canada develop it keeping our population in mind. Indians cannot afford to be foolish to reject technology where crores of tax payers' money has already been invested to improve agriculture. If there is a solution through conventional breeding let it be! But now a decision has to be taken," said a scientist who works with a premier agri institute. Mr Ram Kaundinya felt that there is still a window for dialogue between the stakeholders. He said, "It is time for an informed and constructive dialogue among stakeholders under the auspices of the government to iron out differences and arrive at a common action plan with the objective of producing enough food to feed our Rs 150 crore population by 2030 and our Rs 180 crore population by 2050." The Prime Minister, Mr Narendra Modi's earlier visit to agri-biotech lab in Queensland University of Technology (QUT), Australia and his words "per drop more crop" is seen as a ray of hope by the agri-biotech industry. As per sources, currently a consensus is being built on the issue and even the Union Environment Minister, Mr Prakash Javadekar has assured that the biosafety test for 6 years could be a provision before a final go ahead. Science & technology and agriculture ministries have already been in favor while it is the environment ministry that has to do the final clearances and has been reluctant to do so. Therefore, whether 2015 becomes a year of salvation for GM technology or not, would be keenly watched by those concerned. ]]> <![CDATA[Hot Biotech Start-ups: Nature Biochem]]> https://biospectrumindia.com/news/95/5293/hot-biotech-start-ups-nature-biochem.html https://biospectrumindia.com/news/95/5293/hot-biotech-start-ups-nature-biochem.html Fri, 06 Mar 2015 09:13:00 +0530 Mr Srikanth Vemparala, co-founder, Nature Biochem2014: Success, milestones and failuresYear 2014 means, for us, financial year 2014-15 which will end in March 2015. The year has been challenging in terms of business in India due to negative economic sentiment but from beginning of 2015 it seems that things are looking poised for growth with economic sentiment moving from negative to positive.Company has got customer loyalty and satisfaction for sustained business. We have got success in new business segments / industries. The company has increased visibility and made inroads into new markets. These milestones will propel the company's growth in year 2015. For any start up cutting costs is a challenge, we need to address this issue which can be a differentiator between failure & success in the long run. Company has been successful in positioning itself as a product & technical service provider creating a sense of value for the customer in terms of product offering. It is on a long term growth path backed by a good business base. Some of the aspects like funding, scaling and policy are private matters of the company.2015: The Road ahead/PlansConsolidation of domestic business and thrust on export markets planned for year 2015. Diversification into new business segments / industries to hedge business from seasonal & cyclical nature of business in different industries. ]]> <![CDATA[â€œICAR should do more on spreading awareness about GM cropsâ€?]]> https://biospectrumindia.com/interviews/95/6067/icar-should-do-more-on-spreading-awareness-about-gm-crops.html https://biospectrumindia.com/interviews/95/6067/icar-should-do-more-on-spreading-awareness-about-gm-crops.html Thu, 05 Mar 2015 13:21:00 +0530 Q: Scientists feel disheartened because research done by them has been labelled controversial? Shouldn't Indian Council for Agriculture Research (ICAR) have been more forthcoming in supporting genetically modified (GM) technology?I feel that ICAR has not taken a very active role either in promotion or research of GM crops. Many times they have permitted a lot of research projects but it has not realized that whether we are doing it for the sake of research or the end result. In agriculture, the final utility is for the farmers and I think if that is missing, then research will have little meaning. So, I always say that ICAR must take an active part in it. In case of cotton where the ministry of environment permitted so many hybrids, it is the duty of the environment minister to intervene. Although an ICAR member is present on the committee, they should have clearly conveyed that the release of material is under its purview. Scientists doing research are demoralized yet shying away from talking about it. We have potential scientists in the country who can match anyone in the world. This should not have happened. You should allow them to permit this technology whether its India or China. Q: What is your idea of a national biosafety regulator? The efforts to put together a biosafety regulator earlier too have to be applauded. But then, we have those opposing the technology who are trying to create a bogey of sorts wherein they want to show that whatever is being promoted is not correct. Therefore, to take everybody together, we need to have a regulatory system that is acceptable to all. Although I sometimes feel that it might be difficult as there are hardcore oppositions from certain sections who do it just for the sake of it. Therefore, to avoid any further delays, I propose a third party regulator not attached to any ministry with a good number of agriculture scientists.Q: But what should be the composition of such a regulator? You see when the bill was put before the Parliament, the composition has been made clear. I think there are three areas including pharma, agriculture and vertinary where protocols have to be standardized. My concept is clear. It is the regulatory authority's job to see whether the material being released is environmentally safe. Once you say that it is safe, the job of product testing has to be done by the authority which has the power such as ICMR or ICAR.If we take the example of Bt brinjal, it has been proved to be safe by the regulatory authority and now whether it is effective or which hybrids are safe, should be left with ICAR. Q: A prominent scientist once said that over-emphasis on the Bt Brinjal controversy has overshadowed the entire biotech industry. Is he right?He is partially right. Why we say Bt brinjal is because it is a test case for Bt crops. Unless you permit it, Bt brinjal is an equally important crop as you say. Those who are spraying 45 times in Bengal to control pests may surely be willing to use the technology. When we say Bt brinjal people will be proud. However, it is not that it is the only edible crop but we are ready with tomato, potato, rice, and maize as well. But once you see the line is chocked and the kind of opposition with people clamouring around it, demotivation is quite natural. We have 20 crops with research done and ready to release.Q: What about farmer suicides in Maharashtra being linked to Bt cotton?Basically in terms of suicidal data, all of them are not because of technology. It is all projection. As a farmer was just pointing out that there is also pressure from money lenders and existing debts are the main reason behind most of these cases.Regarding safety, awareness on technology and its benefits, there has been a communication gap. It is always difficult for scientists to make the common man understand the insertion of a gene. If I want to talk about it in layman's language, the entire genome and particularly transgenics becomes difficult. Although we tried it in BT cotton, which is now acceptable.The technology has been demonized as if something will happen the moment you consume any crop. What do you have to say to activists who are dead against the technology? It is difficult to explain to a person with no scientific background. It has to be explained in layman's language. The public has got more confused due to the communication gap and hence all the bad ideas.We have launched a mass awareness campaign in local languages to explain it to the masses who are least bothered about the technology. I am sure if we are able to do that, it will definitely help us. Activists need to think logically and not oppose it merely for ideology. Q: Has GEAC been made toothless with no powers of implementation on what it permits?I was told that the new government is playing an active role and there have been a few meetings. They have given permission to field crops. I have been told that there is nothing left with GEAC. That means they are already conducting those meetings. Hence, it is clear that it was made toothless by the previous government. There was some confusion on what will it prove to be after changes in name but I think they certainly have powers.I am sure Mr Javadekar is a man of science and he will do something on this. I urge him to resolve the issues and also involve the state governments once the permissions come from the central government. Without field trials in states, the permissions will not be of much use. Policy has to be fixed. It should go forward otherwise we will be stuck. Q : What is your vision for the agribiotech sector in India?65 percent of area in India is dependent on rains. We should have traits of all important crops with drought tolerance. I think I will have to find food security for the nation and not be dependent. It may be Jowar, Maize, Cotton or important pulses and oil seeds. We are importing oilseeds worth Rs 9,000 crore which is avoidable if we grow our own rapeseed mustard. Classical case is Delhi University where the trials of GM mustard were halted. These issues can be resolved when concentrated upon. Besides Chickpea, we can go ahead with pigeon pea, groundnut etc. Also can we have golden rice? I think we have done wonderful research and converted our own varieties into golden rice. We are already late and it is high time we move forward into these fields.Q: The rush of farmers from villages to urban areas could prove disastrous for India which is an agriculture dependent country. What is your take on this? Lucrative farming has to come with more of precision agriculture. Like in case of grape farmers who can live in cities and yet cultivate grape plants, the love for farming can be increased through awareness.As far as entrepreneurship is concerned, there are a lot of people interested in production, processing, and marketing. There are equal opportunities existing equally in primary, secondary, and tertiary agriculture. While urban areas can be used for testing agriculture produce but ultimately rural areas too benefit. ]]> <![CDATA[Stempeutics secures US patent]]> https://biospectrumindia.com/news/95/5247/stempeutics-secures-us-patent.html https://biospectrumindia.com/news/95/5247/stempeutics-secures-us-patent.html Thu, 05 Mar 2015 12:42:12 +0530 Stempeutics Research's stem-cell based drug Stempeucel has received a process patent from the United States Patent and Trademarks Office. "The patent granted is a strong recognition for Stempeutics for its sustained excellence of scientific and clinical work," said Mr B N Manohar, chief executive of Stempeutics, in a statement. The drug is for the treatment of Critical Limb Ischemia (CLI). It directly addresses the root cause of the disease, unlike other drugs which typically treat the symptoms and not the disease itself. "We believe that the Stempeucel is a game-changer offering, an advanced therapeutic treatment for millions of patient suffering with this dreadful disease," said Mr Manohar. Stempeutics has already submitted its applications to Drug Controller General of India (DCGI) to obtain marketing authorization approval for Stempeucel. ]]> <![CDATA[Baxter acquires SuppreMol]]> https://biospectrumindia.com/news/95/5239/baxter-acquires-suppremol.html https://biospectrumindia.com/news/95/5239/baxter-acquires-suppremol.html Thu, 05 Mar 2015 12:15:31 +0530 Baxter International has announced that it has acquired SuppreMol for approximately $225 million (EUR 200 million) before working capital and other adjustments. SuppreMol, a germany-based biopharma firm, develops treatment for autoimmune and allergic diseases. The acquisition includes SuppreMol's early-stage development portfolio of novel biologic immunoregulatory therapeutics for the treatment of autoimmune diseases. In addition to the portfolio, Baxter also acquires and will continue to operate SuppreMol's operations in Munich. SuppreMol's pipeline includes lead candidate SM101, an investigational immunoregulatory treatment that has completed Phase 2a studies in idiopathic thrombocytopenic purpura (ITP, a disorder causing low platelet levels) and systemic lupus erythematosus (SLE, a disorder in which the immune system attacks healthy tissue). ''SuppreMol's portfolio of novel investigational treatments complements and builds upon our leading and differentiated immunology portfolio, offering the opportunity to expand into new areas with significant market potential and unmet medical needs in autoimmune diseases,'' said Dr Ludwig Hantson, president of Baxter BioScience. ''Matching therapeutic innovation with market needs is challenging for biotech companies. Working with Baxter, a global immunology leader, is the ideal setting for SuppreMol's promising therapeutic projects to deliver on our most ambitious goal to treat important autoimmune diseases and severe allergies,'' said Dr Klaus Schollmeier, CEO of SuppreMol. ]]> <![CDATA[India & France partner to promote red biotech]]> https://biospectrumindia.com/news/95/6234/india-france-partner-to-promote-red-biotech.html https://biospectrumindia.com/news/95/6234/india-france-partner-to-promote-red-biotech.html Thu, 05 Mar 2015 10:49:14 +0530 Behind the initiative are Indo-French Center for the Promotion of Advanced Research (CEFIPRA) is India's first and France's only bilateral organization, Biotechnology Industry Research Assistance Council (BIRAC), a Public Sector Undertaking 'Not-for-Profit Company' under Ministry of Science and Technology, Government of India and Bpifrance financement (hereafter referred as Bpifrance) , a public investment bank in France. The project proposal will be focused on development of industrial application oriented health technologies in the areas of cancer, cardiac and infectious diseases. The themes can include identification of new targets or biomarkers that leads to development of sensitive, specific and affordable diagnostic tests is prime focus of the call. Also, the development of new therapeutic options in terms of therapeutic protein or drugs are also encouraged for these targeted disease in the current call that has potential for commercialization. Besides that the proposal on affordable process development for existing therapeutics will also be encouraged that have potential implication on effective industrial scale-up for cost effective production. Project proposal shall have at least one register company (start-ups/ SMEs) from India and one from France (start-ups/ SMEs) each as joint applicant. The applicant should be start-ups and SMEs Company of both regions. They can have co- applicants and collaborators from academia, reseach or industry. ]]> <![CDATA[Takeda appoints Christophe Weber as CEO ]]> https://biospectrumindia.com/news/95/6553/takeda-appoints-christophe-weber-as-ceo-.html https://biospectrumindia.com/news/95/6553/takeda-appoints-christophe-weber-as-ceo-.html Wed, 04 Mar 2015 17:06:02 +0530 Japanese pharma major, Takeda Pharmaceutical Company Limited announced that its Board of Directors decided to promote Christophe Weber, Representative Director, President and Chief Operating Officer (COO), to Representative Director, President and Chief Executive Officer (CEO), effective April 1, 2015.Yasuchika Hasegawa, Representative Director, Chairman of the Board & CEO, will assume the position of Representative Director, Chairman of the Board. The appointment is the result of a transparent and objective decision-making process endorsed by the Nomination Committee, which has been established as an advisory body to the Board of Directors and whose chairperson is an Outside Director. It has been also decided that the position of COO will no longer exist effective April 1, 2015. Christophe Weber, the Representative Director, President and COO, said, "First, I would like to thank Yasuchika Hasegawa and the Board of Directors for their trust. I am honored and thrilled with the role of CEO and determined to fulfill my duties. I will devote all my energy to leading the new Takeda organization from April 1, 2015, and continue to make contributions to patients and healthcare professionals, to engage and motivate our employees, while responding to the expectations of investors and shareholders." Yasuchika Hasegawa, the Representative Director, Chairman of the Board & CEO, said, "Since he became COO of the Company last April, I have been supporting Christophe and at the same time carefully observing his performance as a CEO successor. I have concluded that he is ready to assume Takeda's CEO role, and therefore I have decided to appoint him CEO when the new organizational structure takes effect on April 1, 2015. Under "Takeda-ism (Integrity: Fairness, Honesty, and Perseverance)," I am confident that Christophe will blaze a new trail in our efforts to help people realize better health and a brighter future." ]]> <![CDATA[Hospira's Vizag plant under USFDA radar]]> https://biospectrumindia.com/news/95/7726/hospiras-vizag-plant-under-usfda-radar.html https://biospectrumindia.com/news/95/7726/hospiras-vizag-plant-under-usfda-radar.html Wed, 04 Mar 2015 12:48:45 +0530 On February 25, 2015, Hospira Healthcare India Private Limited (Hospira India), a subsidiary of Hospira, Inc., received a Form 483 from the FDA containing 14 observations relating to an inspection of Hospira India's pharmaceutical manufacturing facility nearing commercial operation in Visakhapatnam, India. The inspection was conducted over the period from February 16 through February 25, 2015. The company intends to respond fully and in a timely manner to the observations contained in the Form 483. There can be no assurance that the FDA will be satisfied with the company's response. The company must obtain the approval of the FDA in order to commercialize products produced at the Vizag facility. ]]> <![CDATA[Dr Datsons Labs to supply anti-malarial drugs to Yemen]]> https://biospectrumindia.com/news/95/7792/dr-datsons-labs-to-supply-anti-malarial-drugs-to-yemen.html https://biospectrumindia.com/news/95/7792/dr-datsons-labs-to-supply-anti-malarial-drugs-to-yemen.html Wed, 04 Mar 2015 12:46:48 +0530 Dr Datsons Labs announced that it has signed a marketing and distribution deal with Yemen's Al-Mugdh Pharma to sell its anti-malarial drugs in Yemen. The order is estimated to be about Rs 80 crore, said the company in its filing to BSE. Mr Sameer Talim, CEO, Dr Datsons Labs, commented, "The talk between the two companies was going on for last six months and there are certain regulatory aspects that need to be addressed before the commercialization of the 5 products to be exported to Al-Mugdh Pharma." ]]> <![CDATA[Experts laud inclusion of NCDs in national health policy]]> https://biospectrumindia.com/news/95/6764/experts-laud-inclusion-of-ncds-in-national-health-policy.html https://biospectrumindia.com/news/95/6764/experts-laud-inclusion-of-ncds-in-national-health-policy.html Wed, 04 Mar 2015 09:59:00 +0530 With NCDs contribution to mortality in India expected to increase from 53 percent in 2008 to 73 percent by 2030, the health policy analysts across India feel that the efforts to tackle have to be stepped up in a big way. While lauding the inclusion of NCDs for the first time in the draft National Health Policy 2015, it is being termed as a formative step towards achieving the vision of healthy India. The health experts emphasized that it is important to have a result-oriented action plan, with specific focus on awareness and early diagnosis, systematic approach to NCDs, healthcare financing, and training and development of healthcare workers and paramedical staff. Underlining the need for an integrated action plan for NCDs in India, Dr Kenneth Thorpe, the chairman of the Partnership to Fight Chronic Diseases (PFCD) said, "NCDs are the major cause of mortality in India. Building and strengthening primary healthcare network with a focus on disease screening, prevention, risk-factor control and health promotion should form the rudimentary structure of the integrated action plan to reduce morbidity and mortality associated with NCDs."He further said that the training and development of healthcare workers in primary setups as well as healthcare financing are equally critical for effective implementation of the action plan. The PFCD, a global organisation committed towards raising awareness and finding sustainable solutions on NCDs, has been working in coordination with the medical fraternity, policy makers and patient groups to identify the challenges and draw an action plan. Apart from taking its toll on health, NCDs also affect productivity and economic growth. A recent study by the WHO has found that nearly 26 per cent of the population in India are at the risk of dying young (30-70) from one of the four main NCDs. Cardiovascular diseases (CVDs) form a major share of NCDs,while chronic respiratory disease, cancer and diabetes also constitute a major share. Moreover, increased vulnerability of ageing population to NCDs is resulting in economic stress on both the private households and government.Dr. Anand Krishnan, Professor, Center for Community Medicine, AIIMS - New Delhi said, "India is facing a serious threat from NCDs. A lot has been said and recommended when it comes to preventing and controlling the continuously growing burden of NCDs. It is crucial that both the government and private sector should adopt a unified approach and work in close coordination to identify effective solutions and reduce NCDs burden. Now it is high time that the government should frame strong policies and guidelines, and at the same time create a framework and infrastructure to execute them efficiently, in order to deal with the growing burden." A unique combination of disease-specific insurance products, medicines, innovative technology and lifestyle changes can be very beneficial in thwarting the challenge posed by NCDs.The strengthening of primary healthcare network is one such critical area where government needs to focus on in order to ensure the success of its action plan. Moreover, the promotion of mainstream alternate therapies like ayurveda, yoga and naturopathy can also result in providing cost-effective management of NCDs, as these conditions require lifelong management. ]]> <![CDATA[Mitra's CANScript validated for personalized cancer care]]> https://biospectrumindia.com/news/95/5864/mitras-canscript-validated-for-personalized-cancer-care.html https://biospectrumindia.com/news/95/5864/mitras-canscript-validated-for-personalized-cancer-care.html Wed, 04 Mar 2015 09:26:00 +0530 Mitra Biotech, a cancer diagnostics company, announced that a study validating its flagship platform CANScript has been published in Nature Communications, an open access, multidisciplinary journal dedicated to publishing high-quality research in all areas of the biological, physical, chemical and earth sciences. Papers published by the journal represent important advances of significance to specialists within each field. The article 'Predicting clinical response to anti-cancer drugs using an ex vivo platform that captures tumor heterogeneity' was published in Nature Communications on February 27, 2015. "The study is the first of its kind in delineating the importance of capturing tumor heterogeneity to elicit accurate prediction of clinical response," said Dr Leena Gandhi, one of leading oncologists and investigator at Dana Farber Cancer Institute at Boston, who is not associated with the study. "This platform would not only be beneficial in enabling physicians to select the right mode of treatment, but also speed-up oncology drug development, thereby reducing go-to market time and costs," she added. Scientists from Mitra reported key findings that may open a new avenue in predicting clinical response to anti-cancer drugs. The team showed that by maintaining the complex structure and behavior of tumors in tissue culture plates, CANScript can predict the response of individual patient tumors to anti-cancer drugs. The findings is a result of collaborative efforts undertaken by a team from Mitra Biotech, Harvard Medical School, Dana Farber Cancer Institute, the Broad Institute at MIT along with other institutions in the United States and India. "CANScript is a novel platform based on systems biology, and it has the ability to change the paradigm in cancer treatment," stated Dr Padhma Radhakrishnan, one of the senior team members. Unlike other 3D technologies, CANScript facilitates a thorough understanding of the biology of a tumor in a truly personalized setting while maintaining the slices of tissues in a plate. "We do not limit our analysis to a specific gene or a drug pathway; rather, we examine the complete tumor ecosystem in order to predict both positive and negative clinical responses using a common set up," said Dr Biswanath Majumder, the lead author of the paper. ]]> <![CDATA[World's first 'Birth Defects Day' observed]]> https://biospectrumindia.com/news/95/5842/worlds-first-birth-defects-day-observed.html https://biospectrumindia.com/news/95/5842/worlds-first-birth-defects-day-observed.html Tue, 03 Mar 2015 16:27:36 +0530 The first World Birth Defects Day is being observed on 3 March, 2015, to put the spotlight on this under-recognised problem. The World Birth Defects Day is an initiative of 12 global health organizations to raise awareness about the occurrence of birth defects, develop and implement primary prevention programs, and expand referral and care services for all persons with birth defects. In many countries, birth defects are one of the leading causes of death in infants and young children. Infants who survive and live with these conditions are at an increased risk for long-term disabilities. Birth defects are common, costly and critical health challenges globally and particularly in the South-East Asia Region which reported 49 000 new-born deaths due to birth defects in 2013. "But a large number of these deaths can be prevented with cost effective measures through the existing health care systems. On this occasion WHO urges countries to take measures to prevent as well as minimise the sufferings of children born with birth defects, with timely and appropriate care," said Dr Poonam Khetrapal Singh, regional director, WHO South-East Asia regional officeThe most common birth defects are heart defects, neural tube defects and Down's syndrome, with 94% of the severe ones occurring in middle and low resource settings. Infants who survive with birth defects suffer long-term disability which impairs them, their families and societies due to the social and economic consequences. Dr Singh further added, "The problem can only be addressed with a multidisciplinary, multisectoral and multiple programme approach with services involving health, nutrition, food industry, social welfare sectors and civil society, as multiple factors cause birth defects." Socio-economic conditions where mothers are susceptible to malnutrition, iodine deficiency, folic acid insufficiency; other health conditions such as obesity and diabetes; infections like rubella; and environmental factors like exposure to pesticides, medications, alcohol, tobacco, are leading causes of birth defects. Advanced maternal age causes Down's syndrome in babies while cultural practices such as marriages among first cousins increases the risk of serious birth defects. "We also need to build awareness among the people, the programme managers and health workers to seek and provide early care for their children born with birth defects. Timely and appropriate care can cure or minimise the effects of birth defects in children," Dr Singh emphasized. Addressing birth defects is a key intervention to provide every child best health possible and potential for a full and productive life. "It is also key to reducing infant mortality rate and achieving the Millennium Development Goal 4, to which all countries are committed," she ended. ]]> <![CDATA[Jubilant receives ANDA approval for asthma drug]]> https://biospectrumindia.com/news/95/5498/jubilant-receives-anda-approval-for-asthma-drug.html https://biospectrumindia.com/news/95/5498/jubilant-receives-anda-approval-for-asthma-drug.html Tue, 03 Mar 2015 15:30:53 +0530 Jubilant Life Sciences has received Abbreviated New Drug Application (ANDA) final approval from the US Food and Drug Administration (US FDA) for Montelukast Sodium Chewable Tablets, 4 mg and 5 mg, the generic version of Singulair chewable tablets (of Merck), which is used for the treatment of asthma and to relieve symptoms of seasonal allergies. The total market size for Montelukast tablets as per IMS is $83 million per annum. As on December 31, 2014, Jubilant Life Sciences had a total of 781 filings for formulations of which 333 have been approved in various regions globally. This includes 72 ANDAs filed in the US, of which 35 have been approved and 46 Dossier filings in Europe. So far, it has received 10 ANDA approvals during FY 2015. ]]> <![CDATA[Health minister terms budget as gaint leap for healthcare]]> https://biospectrumindia.com/news/95/6658/health-minister-terms-budget-as-gaint-leap-for-healthcare.html https://biospectrumindia.com/news/95/6658/health-minister-terms-budget-as-gaint-leap-for-healthcare.html Tue, 03 Mar 2015 14:43:38 +0530 Mr J P Nadda in his budget reaction stated that the resolve to support the health sector in a big way has been shown by the outlay for health in the Budget of Rs 33,150 crore. Moreover, announcement of five AIIMS in Jammu & Kashmir, Himachal Pradesh, Punjab, Assam and Tamil Nadu and AIIMS-like institute in Bihar will provide a quantum jump in healthcare in these states and the neighbouring areas. The Health Ministry will implement these in the shortest possible time, the Health Minister stated. "The announcements of various mechanisms in expanding the healthcare insurance to the needy is a laudable step towards making healthcare affordable and accessible to all, he added. "I welcome the move towards the Universal Social Security System backed by Accident Insurance and Bima Yojana." The health minister stated that the focus within the Budget on Swachch Bharat and linking this with healthcare will address broad-based health issues in the country. This will lead to greater awareness among the people regarding the importance of hygiene. He added that good health will enable higher productivity in various sectors, and thus forms an integral component of the development agenda of the country. The target to construct 6 crore toilets will significantly impact health outcomes in the country. ]]> <![CDATA[SRL Diagnostics awards 'women of substance']]> https://biospectrumindia.com/news/95/4936/srl-diagnostics-awards-women-of-substance.html https://biospectrumindia.com/news/95/4936/srl-diagnostics-awards-women-of-substance.html Tue, 03 Mar 2015 12:40:51 +0530 On the occasion of International Women's Day, SRL Diagnostics on March 02, 2015, honoured and felicitated five exceptionally spirited women from the city, who despite all odds in their lives have emerged winners and are role models for many. These spirited women were honoured by SRL Diagnostics with high end cervical cancer screening and a lifetime offer of SRLs premium health screening package. In an endeavour to promote the message of preventive healthcare, the diagnostic chain also released a report on 'Importance of early diagnosis in women'. The 5 women felicitated included Ms Sonia Choudhary, an acid attack survivor; Ms Anjina Rajagopalan, a social philanthropist; Ms Anna Marie Lopes, domestic violence survivor; Ms Omkari, a cab driver and Ms Rajni Bhagat Arora, a cancer survivor. At the felicitation event held at Press Club, Mr Sanjeev Vashishta, CEO, SRL Diagnostics told BioSpectrum, "We have been at the forefront of the diagnostic revolution in India and will continue to fulfill our social responsisbilities as well. It gives me immense pleasure to acknowledge the spirited life of these five women which in itself is inspiring for all of us. In our small way we want to offer our gratitude by offering them free cervical cancer screening once in every five years in addition to a lifetime annual health check up." At the event, SRL Diagnostics released a report on the importance of early diagnosis in women. As part of the report it emerged thatmost of the women are not knowledgeable about the changes that their bodies undergo over time. Sometimes,the changes that seem normal can be a warning signal forthe most deadly diseases. These alarming statistics reveal the grim scenario of women's health; at a national and international level. It is stated that according to the National Family Health Survey, more than half of women in India (55 percent) have anemia. Registrar General of India reports that cardiovascular diseases (CVD) as the most important cause of death in women. Of more than 10 million deaths annually in India, almost two million are due to diseases of circulatory system, of which 40 percent are women. On the other hand almost, 2.1 million women die of diabetes each year in the world, making diabetes the ninth leading cause of death among women. This number is expected to rise to 192 million by the year 2025. Around 40 million Indians suffer from thyroid related disorders, of which 60 percent are women. International Osteoporosis Foundation (IOF) report implied that the indicator of low vitamin D levels and bone density among women all over the world is more rampant as compared to men. Osteoporosis is estimated to affect 200 million women worldwide. "Women form the nucleus of every family. Unfortunately they are the most neglected section of our society. There is an urgent need for action to propagate the prominence of preventive healthcare in women. It needs to combat all kinds of ignorance regarding women's health, which is showing an alarming upward trend of late. At SRL Diagnostics, we lay emphasis on prevention and not just an early detection. Symptoms if treated timely and long before they develop into a full blown serious ailment are always better than late action which means higher expenses, misery and anxiety for the patient and the family." Mr Vashishta added further. ]]> <![CDATA[GSK announces changes to its Board]]> https://biospectrumindia.com/news/95/6659/gsk-announces-changes-to-its-board.html https://biospectrumindia.com/news/95/6659/gsk-announces-changes-to-its-board.html Tue, 03 Mar 2015 12:38:42 +0530 GlaxoSmithKline (GSK) has announced that Sir Christopher Gent will step down as chairman of GSK at the company's annual general meeting (AGM) on 7 May 2015. He will be succeeded by Sir Philip Hampton with effect from the end of the AGM. Sir Philip joined GSK's board as an independent non-executive director on 1 January 2015, and will become deputy chairman on 1 April 2015. Sir Philip chairs the company's nominations committee. He will remain chairman of RBS until 31 August 2015. In addition, Mr Tom de Swaan, independent non-executive director, is not seeking re-election to the Board at the AGM. He has been a Board member for 9 years and is currently chairman of the remuneration committee and a member of the audit & risk Committee (of which he was previously chairman), and the nominations committee. A successor for Mr de Swaan as Chairman of the remuneration committee will be announced in due course. ]]> <![CDATA[Sun Pharma to buy GSK's Opiates business ]]> https://biospectrumindia.com/news/95/6727/sun-pharma-to-buy-gsks-opiates-business-.html https://biospectrumindia.com/news/95/6727/sun-pharma-to-buy-gsks-opiates-business-.html Tue, 03 Mar 2015 12:37:32 +0530 GlaxoSmithKline (GSK) and Sun Pharmaceutical announced that their respective wholly owned subsidiaries have reached an agreement related to GSK's Opiates business in Australia. The current GSK Opiates business including related manufacturing sites in Latrobe (Tasmania) and Port Fairy (Victoria) and its portfolio of opiates products along with inventory, will transfer to a subsidiary of Sun Pharma. The product portfolio consists of poppy-derived opiate raw materials that are primarily used in the manufacture of analgesics for the treatment of moderate to severe pain. All employees from both sites will also be offered employment by Sun. The transaction will allow GSK to simplify its operations in Australia and allow it to focus on delivering its innovative product portfolio that will be central to the company's growth strategy in this country. Mr Steve Morris, GM, GSK Opiates said, "The Opiates business has been an important part of our Australian business for many years, but as our portfolio transitions, we believe now is the right time to hand this business over to someone else. Sun Pharma has an established footprint in this market and, with the addition of our highly skilled employees; I believe they are well-placed to take the business forward." "The global Opiates market holds good potential and the addition of GSK's Opiates business will strengthen our positioning further. The acquisition is a part of our strategy towards building our portfolio of opiates and accessing strong capabilities in this segment," said Mr Iftach Seri, executive vice-president of API business at Sun Pharma. The financial terms of the transaction were not disclosed. The transaction closure is subject to customary closing conditions and requisite regulatory and other approvals, and is expected to close by August 2015. ]]> <![CDATA[Toujeo receives positive opinion from CHMP]]> https://biospectrumindia.com/news/95/6602/toujeo-receives-positive-opinion-from-chmp.html https://biospectrumindia.com/news/95/6602/toujeo-receives-positive-opinion-from-chmp.html Mon, 02 Mar 2015 14:17:54 +0530 Toujeo has demonstrated a more stable and a prolonged glycemic control that lasts beyond 24 hours compared with Lantus (insulin glargine [rDNA origin] injection, 100 U/mL) with low within-individual, within-day blood sugar variability. "Today's CHMP opinion is another step forward to make Toujeo available to people living with diabetes who are currently not at their glycemic target, or are about to start insulin therapy," said Mr Pierre Chancel, senior VP, global diabetes, Sanofi. "We are confident that we can soon add this new treatment option to our portfolio to help patients reach their blood sugar goals." The CHMP positive opinion of Toujeo is based on results from the EDITION clinical trial program, a worldwide and extensive series of phase III studies evaluating the efficacy and safety of Toujeo compared to Lantus in more than 3,500 adults with type 1 or type 2 diabetes who were uncontrolled on their current therapy. Toujeo demonstrated effective blood sugar control, with a favorable safety profile. Toujeo significantly lowered hypoglycemic (low blood sugar) risk in people with type 2 diabetes at any time of the day and night-time as compared with Lantus. The European Commission (EC) is expected to make a final decision on granting marketing authorization for Toujeo in the EU in the coming months. Toujeo was approved by the US Food and Drug Administration and is under review by other regulatory authorities around the world. Once approved, Toujeo will be available in the Toujeo SoloSTAR, a disposable prefilled pen which contains 450 insulin units (IU), and it has a maximum single injection dose of 80 IU. ]]> <![CDATA[Dr Barrett appointed as the founding director of CTTV]]> https://biospectrumindia.com/news/95/5347/dr-barrett-appointed-as-the-founding-director-of-cttv.html https://biospectrumindia.com/news/95/5347/dr-barrett-appointed-as-the-founding-director-of-cttv.html Mon, 02 Mar 2015 14:16:51 +0530 Dr Barrett has been involved in the CTTV since its inception in 2014 and will begin his new role on 1 May 2015. The CTTV, launched one year ago, uses genome-scale experiments and analysis to validate therapeutic targets and focus research into treatments for a wide range of human diseases, including cancer, inflammatory bowel disease and respiratory disease. The CTTV is committed to sharing its data openly with the scientific community. Dr Jeff Barrett, director, CTTV, expressed, "We've made amazing progress in the past ten years towards understanding the relationship between genetic variation and disease risk. The CTTV offers an unprecedented opportunity to apply that knowledge to a long-standing problem in drug discovery: how can we narrow the search for new therapeutic targets from the whole genome to the most promising individual genes? "We are applying methods and technologies available on the Wellcome Genome Campus to help pharmaceutical researchers focus their detailed studies of biological mechanisms and improve their methods for designing effective medicines. The CTTV blends the pharmaceutical industry's sense of enterprise and motion, an academic style that gives questions the time and patience they need, and public data services to integrate many layers of knowledge. Open Data underpins everything, so that what we produce can ultimately benefit everyone." Dr Barrett is currently a group leader at the Wellcome Trust Sanger Institute, where his research group analyses genomic variation in thousands of individuals to identify genetic risk factors for disease. Originally trained in physics, he was inspired to move into computational biology in Mark Daly's lab at the Whitehead Institute in Cambridge, Massachusetts, where he developed the Haploview analysis software and joined the HapMap project. ]]> <![CDATA[â€œAgrovison Southâ€?concludes on a positive note]]> https://biospectrumindia.com/news/95/4953/agrovison-southconcludes-on-a-positive-note.html https://biospectrumindia.com/news/95/4953/agrovison-southconcludes-on-a-positive-note.html Mon, 02 Mar 2015 12:18:11 +0530 "Agrovision South" organised by Karnataka Small Scale Industries Association (KASSIA) in association with MM Activ Sci-Tech Communications (MM Activ) in Belagavi concluded on a positive note. The event, held Between Feb21-23, 2015, showcased Innovations in Agriculture and featured over 100 exhibitors,18 workshops and 28 eminent speakers. Agrovision South's core theme was "Building Sustainable Livelihoods and Increasing Farmers' Income and SMEs role in Food Processing." The event was three-days of Knowledge and Technology sharing on farm practices and food processing creating a unique opportunity for small scale industries, entrepreneurs and farmers to assimilate the latest products, services, technology in Agriculture and allied sectors. The key topics that were covered in the workshops included water conservation technologies and rain-fed agriculture, new technology in Sugarcane production and processing, food safety issues for export of agriculture commodities, nutri cereals for human health, on gherkin, which has been a major success in Karnataka, Rice's of Karnataka, cultivation and exploitation, fruit and vegetable processing, fisheries, another promising enterprise in Karnataka, dairy and the product processing and marketing, soybean as an industrial crop, organic farming for niche markets, agri finance, ICT in agriculture and an open panel discussion on farmer's income. The event focused on agro, food processing and related sectors across south India and in particular from the neighbouring districts of Belagavi, Bijapur, Bagalkot, Bidar, Bellary, Gulbarga, Raichur, Yadgiri, Gadag, Dharwad, Haveri, Koppal, in addition to several central PSUs and large industries. Mr Ravi Boratkar joint MD, MM Activ and organizing secretary, Agrovision South, said, "We are very happy with the response of the farmers who have come from across the region to participate in Agrovision South. We have ensured that the equipment, technology and workshop topics match with the needs of the local population. The modern technologies that are currently showcased here are meant to attract the people back to farming and food processing. The Govt. of Karnataka has also offered help in many ways to help farmers improve there livelihood by adopting new methodologies. Some of the key areas that were addressed included innovative measures to increase crop productivity, soil testing techniques, harnessing farm produce from lab to land, and agricultural extension practices such as food processing and related sectors." Mr Chidananda M Rajamane, president, KASSIA and organizing secretary, Agrovision South, said, "KASSAI decided to bring together the agricultural sector and the MSME sector with specific focus on food processing. We are very happy with the outcome of Agrovison South as it has benefited the region tremendously." The event was inaugurated on 21st Feb 2015 by Mr Siddaramaiah, CM of Karnataka, in the presence of Mr Satish L Jarkiholi, excise minister, Govt of Karnataka and Belagavi district minister; Mr SR Patil, Minister for IT, BT and S&T; Planning & Statistics, Govt of Karnataka; Mr Krishna Byre Gowda, Minister of Agriculture, Govt of Karnataka; Dr B Gurappa Naidu, chairman KSSIDC; Mr Prakash Babanna Hukkeri, Member of Parliament, Chikkodi Parliamentary Constituency; Mr Suresh Channabassapa Angadi, Member of Parliament, Belagavi Parliamentary Constituency and others. Some of the key participants included the Ministry of Agriculture, Govt of Israel, several departments from Govt of Karnataka, KBITS, KSSIDC, KVK, Coir Board, several universities and corporate such as UPL, Reliance Industries, Paragon Synthetics and Polymers among others. ]]> <![CDATA[CII's take on medical device duty implications in budget totally unfounded: AIMED]]> https://biospectrumindia.com/news/95/6081/ciis-take-on-medical-device-duty-implications-in-budget-totally-unfounded-aimed.html https://biospectrumindia.com/news/95/6081/ciis-take-on-medical-device-duty-implications-in-budget-totally-unfounded-aimed.html Mon, 02 Mar 2015 09:08:00 +0530 "Nothing can be further from truth. CII's assertions is absolutely unfounded, misleading and totally against PM Modi's vision of 'Make in India'," said Mr Rajiv Nath, Forum Coordinator of Association of Indian Medical Device Industry (AIMED), the largest industry body of medical device manufacturers in India. AIMED has strongly refuted the assertions made by CII that raising import duty will hurt consumers' interest and would be detrimental to Indian medical device industry or Indian consumers. Mr Nath in a statement said that he was rather aghast that a respected industry body like CII has permitted itself to be misused by groups who are inimical to country's long term interests and did not want domestic manufacturing to take off in India. He further pointed out that duty rationalization by lowering the duty on raw materials and increasing it on finished devices will not only create a level playing field between imports and domestically manufactured goods but will also give the much needed impetus to domestic manufacturing. He added that duty rationalization will also attract MNCs to set up manufacturing units within the country rather than continuing with their preferred route of imports to market their products in India. "If government really wants to realize the PM's vision of 'Make in India', it needs to correct the flawed legacy duty structure which made us an import dependent nation in the critical sector of medical devices," said Mr Nath. Mr Nath asserted that the tactics of spreading false alarm about dramatic rise in prices of medical devices if import duties were raised was dishonest aimed at camouflaging the truth and ground realities. "Fact of the matter is that nobody really knows for sure what the MRP of imported devices are? And MNCs and some unscrupulous importers have been artificially hiking up prices on imported goods, promising supernormal margins to retailers and hospitals to capture market share. Such unhealthy practices have been the major cause for skewed prices of medical devices in the country while leading to near complete annihilation of domestic manufacturing," said Mr Nath adding that, "Government or consumers should not get hoodwinked by such false assertions and self-serving interest groups." Mr Nath added that it seems the agenda of some influential industry associations is to ensure total annihilation of domestic manufacturing and perpetuate the regime of complete import dependency in the critical sector of healthcare. "Some influential industry bodies need to rethink their priorities - whether they are with PM's 'Make in India' vision or with MNCs and unscrupulous importer lobbies who would like to see India remaining import dependent. It's a question of India and Indians' long terms interests vs ensuring profitability for the few," said Mr Nath. AIMED for quite some time now has been voicing its concern about the perilous level of import dependency in the critical sector of USD 5 billion medical device industry, which today is as high as 80 per cent due to myopic and lopsided duty regime pursued by previous governments, which encouraged imports at the cost of ruining domestic manufacturing and innovations. "It does not require rocket science to understand that if import duty is lower on finished products and higher for raw materials; making these products within the country will naturally be more expensive than imports then why will anybody including MNCs manufacture in India. I don't understand as to why CII is trying to spread flawed rationale," said Mr Nath. "And anyway how can Indian consumers suffer if medical devices start getting manufactured within the country in large scale. Its like saying we would have been better off, if we had remained import dependent for items like medicine, cars, refrigerators or even food. It's a weird logic," said Mr Nath. He added that besides the ultimate price advantage of domestic manufacturing, we must not lose sight of concomitant benefits like large scale employment creations, development of our own exports which will come with domestic manufacturing. Mr Nath also pointed out that lopsided duty structure has also been a major drain on country's foreign exchange reserves and this situation will only worsen if flawed inverted duty structure is not rationalized even as industry is expected to grow to USD 30 billion by 2022. Regulatory loopholes concerning imported goods have also been a major cause for artificial price hikes of medical devices in the country due to non-application of certain norms - such as mentioning of MRP - which are applicable on domestically manufactured products but not enforced on imports on their unit packs. "Levy of 1% excise duty would be deterrent for increase of MRP and will make reversal of artificial increase of MRP possible," said Mr Nath. ]]> <![CDATA[TPG invests $146 million in Manipal Hospitals]]> https://biospectrumindia.com/news/95/6592/tpg-invests-146-million-in-manipal-hospitals.html https://biospectrumindia.com/news/95/6592/tpg-invests-146-million-in-manipal-hospitals.html Sun, 01 Mar 2015 09:53:00 +0530 Manipal Health Enterprises (MHEPL) has said that global private investment firm TPG Capital had purchased a significant minority stake in the company for Rs 900 crore, says reports. "In MHEPL, we have identified a business with extensive global experience and expertise in healthcare, a sector supported by robust growth drivers and with a critical role to play for social advancement in India," said Mr Puneet Bhatia, partner and TPG Capital's head of India in a statement. "Together with TPG's background and experience in the domain of healthcare, Manipal Health Enterprises will look to further expand its presence, with a focus on providing first-rate healthcare to communities in India and beyond," said Mr Swami Swaminathan, executive chairman, MHEPL. Apart from the expansion in the country the focus is to expand overseas in Middle East, Africa and ASEAN countries, he added. However, the company did not disclose the size of the stake acquired by the investment firm. ]]> <![CDATA[Modi govt's 'Budget 2015' bets big on R&D, skills & tech startups ]]> https://biospectrumindia.com/news/95/6129/modi-govts-budget-2015-bets-big-on-rd-skills-tech-startups-.html https://biospectrumindia.com/news/95/6129/modi-govts-budget-2015-bets-big-on-rd-skills-tech-startups-.html Sat, 28 Feb 2015 16:53:00 +0530 The 'Union Budget 2015' presented by the finance minister, Mr Arun Jaitley on February, 28 is being termed as a big bang reform budget. The Modi government has taken few bold steps to ensure that the industry gets back its confidence to grow and help in nation building. Pointing especially towards the role of technology creation in India and enreprenuership to boost 'Make in India' campaign, Mr Jaitley mentioned, "the focus is on creating job creators not job seekers." To begin with, the Prime Minister's pet project, 'Swatch Bharat Abhiyaan' will also include bigger focus on preventive healthcare, paving way for growth of diagnostic industry in India. For the fiscal year 2015-16, the health sector has been allocated Rs 33,152 crore which may be below the industry expectations though it is a good increase from the previous one presented only a few months from elections in 2014. Besides that, there is good focus on skill development as well. With an aim to boost education in states often deprived of opportunities, an Indian Institute of Technology (IIT) in Karnataka and a PG institute of Horticulture in Armtisar will be setup. The budget announcements also included the proposed establishment of All India Institute of Medical Sciences (AIIMS) in Jammu and Kashmir, Punjab, Tamil Nadu, Himachal Pradesh, Bihar and Assam. Three new National Institute of Pharmaceuticals Education and Research in Maharashtra, Rajasthan and Chattisgarh and one institute of Science and Education Research is to be set up in Nagaland and Orissa each. The technical startups have a lot to cheer about. The reduction of tax on royalty payable and fees for technical services reduced from 25 percent to 10 percent to facilitate technology inflow is a very welcome step for sourcing foreign technology. The SETU (Self-Employment and Talent Utilization) Fund to be established as Techno-financial, incubation and facilitation program to support all aspects of start-up business. Rs 1,000 crore to be set aside as initial amount in NITI. Also, the Atal Innovation Mission (AIM) to be established in NITI to provide Innovation Promotion Platform involving academicians, and drawing upon national and international experiences to foster a culture of innovation , research and development. A sum of Rs 150 crore will be earmarked. Industry leaders have expressed their satisfaction on the favourable highlights in the budget. In her first reaction on twitter, the Biocon chairman, Kiran Mazumdar Shaw mentioned, "J&K to have AIIMS - a good measure as J&K has very competent medical human resources including medical education." Dr Habil Khorakiwala, chairman, Wockhardt Biotech gave a rating of 8 out of 10 for the budget. He added, "Indeed a breath taking effort by Finance Minister Arun Jaitley. It envelops every section of society and commits to initiate social security network for all. There are measures for global competitiveness and "Make in India' - a reality." "Overall this has been a forward-looking and stable budget. Specifically, the health exemptions provided for all and, in particular, for the elderly are a major positive. The government has announced 5 new AIIMS, which will both increase access to health facilities in those stated and also provide a training ground for medical professionals. The visa on arrival for 150 additional countries is also a progressive move. This will go a long way in facilitating medical tourism, said Ms Suneeta Reddy, managing director, Apollo Hospitals. Mr Jaitley in the budget also supported the agriculture sector with the help of effective and hassle-free agriculture credit, with a special focus on small and marginal farmers. He proposed the Budget allocation of Rs. 25,000 crore in 2015-16 to the corpus of Rural Infrastructure Development Fund (RIDF) set up in NABARD; Rs. 15,000 crore for Long Term Rural Credit Fund; Rs 45,000 crore for Short Term Cooperative Rural Credit Refinance Fund; and Rs. 15,000 crore for Short Term RRB Refinance Fund. "The budget proposals on agriculture are consistent with the government's focus on addressing the keys challenges of irrigation and soil to boost productivity. Another major announcement is with respect to implement an effective agriculture credit mechanism and focus on small and marginal farmers," Dr KC Ravi, Vice President, Commercial Acceptance & Public Policy, Syngenta South Asia adding further, "The Finance Minister's proposed allocations are also welcome as these shall incentivize farmers. The focus on creating a national agriculture market is also much-needed, and welcome. All these measures supplemented with the Agriculture Ministry's focus to accelerate technology adoption in agriculture will certainly help in boosting agricultural growth and in boosting farmer incomes." As per Mr Ram Kaundinya, director general, ABLE-AG (Association of Biotechnology Enabled Enterprises - Agriculture Group) "The PM's interim budget in 2014 had a very modest increase in financial outlay for the agri-biotechnology sector. With regards to the Budget 2015, widely expected to be a landmark budget, we were looking forward to seeing more stimulus for the agri-biotech industry to enable more productive and long-term gains for the sector. The focus was clearly more on infrastructure and less on incentivising the agri-industry. While this will directly benefit the farm sector and help improve farm incomes, we have always maintained that a more conducive policy initiative for the agri-biotech industry would align the priorities of the Indian seed and biotech industry with the government's 'Make-In-India' mission better as almost all the crop seeds are produced in India, creating huge rural employment and generating incomes for the farmer community." "The finance minister has set a realistic road map for the agriculture sector by addressing the underlying problems of Irrigation, farm credit, and directing farm subsidies into the farmers hands. The Finance Minister's statement on creating a better market for farmers produce and addressing the issue of value addition in Agriculture in laudable. CropLife India believes that the budget initiatives will go a long way in improving farmers' livelihood and achieve a sustainable 4 percent growth of agriculture sector.," said Mr Ram K Mudholkar, business director, South Asia, DuPont Crop Protection and chairman, CropLife India. However, there is healthy criticism too from Mr Rajiv Nath, forum coordinator, Association of Medical Devices Industry (AIMED) who says, "Intentions galore but fine print has been missing. We were definitely expecting some significant tweaks on the inverted duty structure but it has been limited to only 22 items, so let the details emerge to see if these will benefit medical device manufacturing," Mr Nath who is also the joint managing director, Hindustan Syringes and Medical Devices Ltd (HMD) added further "It's a budget which tries to paint a picture of coming 'Acche Din' but for now, one needs to be content with hope and anticipation." To meet these challenges, the finance minister has underlined that the public sector needs to step in to catalyse investment, make in india programme to create jobs in manufacturing, continue support to programmes with important national priorities such as agriculture, education, health, MGNREGA, rural infrastructure including roads. Mr Jaitley in the budget also supported the agriculture sector with the help of effective and hassle-free agriculture credit, with a special focus on small and marginal farmers, Mr Jaitley proposed the Budget allocation of Rs 25,000 crore in 2015-16 to the corpus of Rural Infrastructure Development Fund (RIDF) set up in NABARD; Rs 15,000 crore for Long Term Rural Credit Fund; Rs 45,000 crore for Short Term Cooperative Rural Credit Refinance Fund; and Rs 15,000 crore for Short Term RRB Refinance Fund. "The budget proposals on agriculture are consistent with the government's focus on addressing the keys challenges of irrigation and soil to boost productivity. Another major announcement is with respect to implement an effective agriculture credit mechanism and focus on small and marginal farmers," Dr KC Ravi, vice president, Commercial Acceptance & Public Policy, Syngenta South Asia adding further, "The Finance Minister's proposed allocations are also welcome as these shall incentivize farmers. The focus on creating a national agriculture market is also much-needed, and welcome. All these measures supplemented with the Agriculture Ministry's focus to accelerate technology adoption in agriculture will certainly help in boosting agricultural growth and in boosting farmer incomes." As per Mr Ram Kaundinya, director general, ABLE-AG (Association of Biotechnology Enabled Enterprises - Agriculture Group) "The PM's interim budget in 2014 had a very modest increase in financial outlay for the agri-biotechnology sector. With regards to the Budget 2015, widely expected to be a landmark budget, we were looking forward to seeing more stimulus for the agri-biotech industry to enable more productive and long-term gains for the sector. The focus was clearly more on infrastructure and less on incentivising the agri-industry. While this will directly benefit the farm sector and help improve farm incomes, we have always maintained that a more conducive policy initiative for the agri-biotech industry would align the priorities of the Indian seed and biotech industry with the government's 'Make-In-India' mission better as almost all the crop seeds are produced in India, creating huge rural employment and generating incomes for the farmer community." "The finance minister has set a realistic road map for the agriculture sector by addressing the underlying problems of Irrigation, farm credit, and directing farm subsidies into the farmers hands. The Finance Minister's statement on creating a better market for farmers produce and addressing the issue of value addition in Agriculture in laudable. CropLife India believes that the budget initiatives will go a long way in improving farmers' livelihood and achieve a sustainable 4 percent growth of agriculture sector," said Mr Ram K Mudholkar, business director, South Asia, DuPont Crop Protection and chairman, CropLife India. However, there is healthy criticism too from Mr Rajiv Nath, forum coordinator, Association of Medical Devices Industry (AIMED) who says, "Intentions galore but fine print has been missing. We were definitely expecting some significant tweaks on the inverted duty structure but it has been limited to only 22 items, so let the details emerge to see if these will benefit medical device manufacturing," says Mr Nath who is also the joint managing director, Hindustan Syringes and Medical Devices Ltd (HMD). As per Mr Abhay Soi, CMD Radiant Life Care which manages BLK Super Speciality Hospital, Delhi and Nanavati Super Speciality Hospital, "The Budget has made some enabling provisions for people to spend more on health insurance and that's one of the welcome steps for the healthcare sector. The emphasis on improving the quality of life and public health through Swachh Bharat is also a welcome move. The increase in tax exemption limit for health insurance from Rs 15,000 to Rs 25,000 is a remarkable feature of Finance Minister Arun Jaitley's maiden full-fledged Budget for 2015-16. As pointed out by Finance Minister as well, the move will encourage more and more people to take health insurance. Apart from this the decision to set-up AIIMS in J&K, Punjab, Himachal Pradesh and Assam shows government's commitment to take quality health care services to people's doorsteps." Commenting on the budget's focus on start ups,Vipul Jain, CEO, Advancells "It is a mixed bag for healthcare sector. Doubling of the deductible health insurance premium from 15,000 to 30,000 is certainly a step in the right direction. This will help people seek out quality healthcare and will stimulate the sector towards fresh investments. Another favorable step was abolition of service tax on patient transport by ambulance and set up of AIIMS like institutes on different parts of the country. However, the budget falls short in making major policy initiatives for health care sector. There are no announcements for pharma sector or major stimulation initiatives to research and development in the healthcare sector. We were expecting major incentives on R&D specially under the Make in India initiative, but the budget has stopped short of it. There are no financial incentives for the healthcare sector for fresh investments in primary and tertiary healthcare delivery model as well. " The industry surely is expecting much more. To meet the challenges that remain there, the finance minister has underlined that the public sector needs to step in to catalyse investment, make in india programme to create jobs in manufacturing, continue support to programmes with important national priorities such as agriculture, education, health, MGNREGA, rural infrastructure including roads. ]]> <![CDATA['Diabetes is a strong growth driver for us']]> https://biospectrumindia.com/interviews/95/4795/diabetes-is-a-strong-growth-driver-for-us.html https://biospectrumindia.com/interviews/95/4795/diabetes-is-a-strong-growth-driver-for-us.html Sat, 28 Feb 2015 09:45:00 +0530 Sanofi's Shantha's human insulin, Insuman, is used in treating patients with type 1 & 2 diabetes, which demands insulin. The company has licensed the product in about 90 countries ever since its first introduction 17 years ago. The manufacturing site is said to be spread across 13,400 square meters. The site is expected to have the capability of manufacturing up to 60 million cartridges per year. According to the company, the unit will start its commercial manufacturing by 2019, and supplying to the regulated markets by 2020. Tech-transfer The company has a similar manufacturing facility located in Frankfurt, Germany. Insuman is a 'tech-transfer' project from Sanofi Frankfurt, using state-of-the-art Isolator technology. "We are happy with the initial kick-start of the ground breaking ceremony which was recently graced by the presence of Hon'ble Chief Minister of Telangana State. The product has huge demand and its production is in its nascent stage, the first lot of Insuman is expected to roll out in 2020," revealed Dr Harish Iyer, CEO, Shantha Biotechnics. Indian diabetes market In India, it is estimated that approximately 65 million people have diabetes as per IDF (International Diabetes Federation) Atlas data. Of these, it is further estimated that 42 lakh patients are on Insulin, of which 33 lakh patients are on regular human Insulin, and 9 lakh patients on analog Insulin. "The Indian market is dominated by regular premix insulin, therefore, the need for Insuman in regular human Insulin category is high," added Dr Iyer while commenting on the market demand for Insuman in India. Initially the company intends to produce Insuman for the Indian market primarily. Later it seeks to expand to other markets like the European Union (EU), if required. Growth driver "We are starting to invest in R&D projects for biotech in India but this is in early stages. It is too early to comment on the revenue that will be generated by Insuman... Diabetes is definitely a strong growth driver for us, both locally and worldwide," he pointed. Shantha started its journey in Hyderabad in 1993. When asked about the manufacturing unit's strategic location, Dr Iyer expressed, "We wanted to incorporate the existing support of the local government and tap the availability of skilled labor for our facility." Asia's biopharmaceutical giant Biocon too, is in the process of erecting its Malaysian plant in Johor with an investment of US $160 million, which is said to be Asia's largest integrated Insulin production plant. The unit is expected to be functional in 2016 or 2017, according to Dr Kiran Mazumdar, CMD, Biocon. While premix insulin tends to dominate the Indian market, there are many physicians who prefer to prescribe regular human Insulin given its advantages in terms of ease of use, availability and affordability. Make in India The industry has pinned its hopes to Narendra Modi's 'Make in India' campaign, hoping to see an increase in the number of investments in life sciences and bringing multinationals back on stage in the country. Adding to it, Dr Iyer highlighted, "The "Make in India" also requires other elements that promise investment into infrastructure such as water, power, and supply chain among others, and good regulatory policies to really help to increase investments." ]]> <![CDATA[Alzheimer's treatment pipeline remains large despite 95% attrition rate]]> https://biospectrumindia.com/reports-white-papers/95/5720/alzheimers-treatment-pipeline-remains-large-despite-95-attrition-rate.html https://biospectrumindia.com/reports-white-papers/95/5720/alzheimers-treatment-pipeline-remains-large-despite-95-attrition-rate.html Fri, 27 Feb 2015 12:40:11 +0530 While drug candidates for Alzheimer's Disease (AD) fail at a much higher rate than the pharmaceutical industry average, the total number of active drugs in the AD treatment pipeline is relatively large at 583, implying a high level of commercial interest, says GBI Research. Its latest report states that 77 percent of AD pipeline drugs are in early stages of development, such as the discovery and preclinical phases, whereas therapeutics in phase III development occupy only 3 percent of the overall pipeline, reflecting a high level of attrition in late-stage trials. Analysis of a large number of clinical trials conducted in the AD market since 2006 yielded an extremely high failure rate across all phases of development: 44 percent for phase I, 69 percent for phase II and 76 percent for phase III, with the latter having almost three times the rate of failure compared with the pharmaceutical industry as a whole. The overall attrition rate across all phases is 95 percent, which further highlights that AD is a very high-risk indication for drug development. In light of these findings, the size of the AD developmental pipeline is surprising, but also indicative of the considerable unmet need and substantial commercial opportunities for strong products. The report notes that the overall AD pipeline is still very much dominated by small molecule drugs, which account for approximately 65 percent of developmental programs, while biologics represent 26 percent. A further breakdown of biological therapies shows that most of these are monoclonal antibodies (mAbs), peptides and vaccines. The diversity of molecule types is most prominent among preclinical programs, but skews towards small molecules in late-stage programs. Indeed, 12 of the 15 phase III therapies are small molecules, while there are only two mAbs, Gantenerumab and Solanezumab, and one protein product. However, the company believes that the pipeline holds some degree of promise, as companies are reacting to the continuing failures of drugs with popular targets by favoring novel mechanisms of action, such as tau, mitochondrial components, and insulin- and calcium-signaling targets, which could yield a greater level of success. ]]> <![CDATA[Lupin, Acceliant tie-up for clinical research]]> https://biospectrumindia.com/news/95/5715/lupin-acceliant-tie-up-for-clinical-research.html https://biospectrumindia.com/news/95/5715/lupin-acceliant-tie-up-for-clinical-research.html Fri, 27 Feb 2015 12:36:03 +0530 Lupin has announced that it has partnered with Bangalore-based Acceliant. As per the deal, Lupin would leverage Acceliant's clinical trial platform for its clinical research and trials across Lupin research programs. "This is an excellent platform for us to showcase our eClinical suite of products that deliver end-to-end clinical trial data management solutions. Together, we hope to raise the level of clinical trial efficiency," said Mr Ven Thangaraj, CTO, Acceliant in a statement. Acceliant's platforms ensure execution of clinical data management activities such as database design and various report formats for business intelligence. "Acceliant's eClinical suite will go a long way in helping us to cost-effectively streamline and expedite our clinical trial processes," said Mr Ravishekar Kasibhatta, VP, Lupin. ]]> <![CDATA[Voisin Consulting expands its capabilities]]> https://biospectrumindia.com/news/95/5684/voisin-consulting-expands-its-capabilities.html https://biospectrumindia.com/news/95/5684/voisin-consulting-expands-its-capabilities.html Fri, 27 Feb 2015 11:50:24 +0530 Besides offices in Bangalore, London and Singapore, among others, Voisin Consulting Life Sciences (VCLS), a leading consultancy firm supporting life science companies throughout product development and commercialization, has opened its second US office in the San Francisco Bay area. Ms Camille R Shore will be providing US FDA regulatory strategic advice to clients worldwide and will be developing new services specific to the local industry, thus adding depth to VCLS US regulatory expertise. "San Francisco was naturally the next step for us," says founder and CEO Dr Emmanuelle M Voisin. "Our expansion is client-driven in order to locally serve the cutting-edge biomedical industry concentrated in this area and to have a presence on the West Coast." With marketing applications in more than 20 countries, Ms Shore will be part of the team responsible for a consistent approach between regulatory submissions across the world. She has successfully developed orphan drugs and therapies indicated for pediatric populations, two of VCLS' historical strengths. "Camille brings more than 30 years of experience working with biotech start-ups as well as large pharma companies. Her broad experience and successful track record further enhance our capabilities to provide clients with a global perspective for designing and executing international regulatory strategies," Dr Voisin added. ]]> <![CDATA[Sanofi receives FDA approval for Toujeo]]> https://biospectrumindia.com/news/95/6106/sanofi-receives-fda-approval-for-toujeo.html https://biospectrumindia.com/news/95/6106/sanofi-receives-fda-approval-for-toujeo.html Fri, 27 Feb 2015 11:22:10 +0530 Toujeo is a once-daily long-acting basal insulin, to improve glycemic control in adults living with type 1 and type 2 diabetes. Toujeo is expected to be available in the US at the beginning of Q2 2015. "Sanofi is proud of its long heritage in diabetes and insulin therapies, including Lantus which has supported patients in the management of their diabetes for more than a decade. With the FDA approval of Toujeo, Sanofi builds on its strong legacy and looks forward to bringing a new treatment option to people living with diabetes," said Mr Pierre Chancel, senior VP, global diabetes, Sanofi. ]]> <![CDATA[Budget 2015: Industry expects a break from the past]]> https://biospectrumindia.com/features/95/3138/budget-2015-industry-expects-a-break-from-the-past.html https://biospectrumindia.com/features/95/3138/budget-2015-industry-expects-a-break-from-the-past.html Fri, 27 Feb 2015 09:57:00 +0530 In the backdrop of Prime Minister, Mr Narendra Modi's speech at the Indian Science Congress on January, 03, 2015, that he will direct respective ministries to look into the industry's concerns, stakeholders are looking optimistically at the upcoming union budget. The positivity this time also comes from the wordings of PM's speech in which he made it clear that in no way the existing unaccountability shall be tolerated in the Indian science and technology. The statements have come at a stage when the biotech industry has been reeling under tremendous pressure due to stunted growth in the last two years. Therefore, it is obvious that all eyes will be on Mr Arun Jaitley when he presents the (what is being touted as popular) budget in the Parliament session starting from February 23. Earlier in his address to the industry chambers during pre-budget consultations, the finance minister had told industry leaders that reviving the manufacturing sector, diversifying its base and preparing it for robust long-run expansion was one of the major challenges. He had assured business heads that improving India's ranking in ease of doing business was a priority. In fact, the Federation of Indian Chambers of Commerce and Industry (FICCI) president, Ms Jyotsna Suri has urged the minister to provide "a genuine non-adversarial and conducive tax environment" for the industry and economy to flourish. "There is a revenue target given to tax officers and because they have to attain that, they often make irrational tax demands. They should be judged on their performance and not on achievement of targets," she said. Own investments or government's helping hand! PM Modi in his speech had also advised industries to increase their own investments into research and development to achieve growth. Bioscience industry in its response has welcomed it but with a reminder that only streamlined regulations could help in achieving that. "I do believe that the PM's speech last month was a landmark one. While lauding Indian scientists for their contribution, he laid down priorities for research in the fields of clean energy, agriculture, biotechnology, agriculture and health care. As a representative of the biotech industry, we found his emphasis on our industry very encouraging, especially in light of it shared as a national priority and an important enabler to nation building," said Mr Ram Kaundinya, director general, Association of Biotechnology Led Enterprises- Agriculture Group (ABLE-AG). He added further, "For agri-universities, scientists and seed companies, the issue is not merely of increasing investments but of being allowed to carry on research in an unhindered and unencumbered manner. We therefore sincerely hope that the PM's thoughts resonate deeply with and find favour with other policy-makers, both in his government and in the opposition and results in a more conducive ecosystem for the agri-biotech industry." While financial investments are important, innovation also should be on high priority felt Mr KV Subramaniam, president and CEO, Reliance Life Sciences, "It is imperative for industry to increase its own investments in research. Equally, it is important to access innovation in external organizations through a structured framework. Without innovation, a company in biotechnology will not be able to move up the value chain to meet unmet medical needs; emanating from new therapies for non-curable or difficult to cure ailments and from being very cost-competitive to address the larger market opportunities in the developing world," he said. Dr Shama Bhat, managing director, Bhat Biotech too fully agrees with the PM Modi's assertion but added that research requires some funding. "I really appreciate the initiatives PM Modi is taking in several fronts. It is important that the advancement of science is very important for the long term growth of any country and India is not an exception. Any developed country in the world today, is so advanced, is because of its investment in Science. It is important that companies also need to be investing in applied research, but for the basic research it has to come from the government." Terming the PM Modi's speech as visionary, Mr Ravi Dawar, director-finance, BD-India, felt that addressing ground realities like removing bureaucracy for approvals for funding was encouraging. His comment on converging industry and government institutions for investments in research are also in right direction, and will spur research and development activity in India. Calling the speech encouraging, Mr Subbarao Appemane, senior vice-president, corporate communications and regulatory affairs, Africa and South East Asia, Mahyco, mentioned, "It will boost the confidence of the scientists and the research institutions especially working in the agri-biotech sector. The investment in research and development is also likely to increase." As per Mr Amol Naikawadi, preventive healthcare specialist and JMD, Indus Health Plus says, "The 100 percent FDI in a separate policy for medical devices is a positive move by the new government. The move will further boost the investment climate in India. Since the government is focusing on prevention ever since their election manifesto was printed, PM and government together are focused towards working on prevention as priority. The sectorial allocation for health needs should be increased from current 1.69 percent of GDP to at least 7 percent of GDP which would be in line with other developing economies of the world.." Explaining the difference between needs of research based industry and others, Dr Arvind kapur, CEO, Vegetable Seed Division, Rasi Seeds, opined, "Research based industry is already increasing their investments in research but industry is looking to the incentives in taxes to further increase their investments. This year budget will surely have element of optimism for higher investments in innovations and research particularly for Agriculture based industry where the industry is looking forward to Tax incentive for research in new technologies and contribute towards sustainability of food production in India." Industry's wish list : Empower us to 'Make in India' "Customs and import duty for many research and manufacturing items. Now, many imported finished products are free of duty, but the raw materials used for making them in "made in India" need to pay duty. How we can be competitive. All previous budgets were not so encouraging and this time also may be the same. Hope PM Modi's budget will be pro progressive with not only 'Make in India' but pro innovation," Dr Shama Bhat added optimistically. Mr Ravi Dawar expects it to lay out a clear roadmap for introduction of GST. He adds further,"Also, the finance minister should announce the next set of reforms which will catalyse the GDP growth to the 6 -7 percent level. Further, it should spell out the specific incentives and actions which will encourage companies to 'Make in India'." Spelling out his wish list, Dr Ram Kaundinya mentioned, "I believe the government recognises this and also believe that its 'Make-In-India' mission integrates well with the priorities of the Indian biotechnology sector. The Indian agri biotech industry has clearly demonstrated through Bt cotton that technology helps in making the 'Make in India' campaign stronger. The policy makers need to understand that budgetary allocations by itself is not enough - the regulatory ecosystem must be improved and strengthened to allow the scientific community to go the last mile and create new strains of agri-biotechnology crops that sustainably address the issue of food security and farmer incomes. To sum this up, I would say that the Indian agri biotech sector needs more incentives for investment in research and for biotech seed production in India." Mr Amol Naikawadi mentioned, "Corporates should also be incentivized for their interest in preventive measures for employees. Government should make routine health check - up mandatory from the age of 25 years through healthcare programmes. Need to create personal health records and encourage screening of diseases amongst the population. Make it mandatory for schools and colleges for initiating health programs for early screening, promoting positive health." Mr Subbarao Appemane said, " Budget this time should provide necessary incentives to the agricultural sector to grow faster. It should encourage investments by private sector. Indian agriculture needs technology for productivity improvement and needs investment in storage and processing infrastructure to increase the share of farmers in the consumer price. With recurring drought situation in various regions of the country, it would be helpful if the government encourage the ongoing research on drought tolerance crops which will not only help in growing crop in less water but will also ensure the farmers are able to sow and harvest crops without depending much on monsoon." Many like Dr Arvind Kapur felt that previous budget did not recognize the need of changing financial needs and not installed confidence in investors to invest in the future needs of the country. "I hope the coming budget will be forward looking and create new environment for growth and investments," says Dr Kapur Mr Subramaniam looks at it from a broader perspective. He thinks that broadly stated, with the long overdue emphasis on manufacturing in India, one can expect a focus on enabling manufacturing in the country; with a mix of schemes and incentives spanning research, investments, reducing taxation, lowering infrastructural barriers and competency development. He elaborates,"The systemic costs of setting up and operating manufacturing units in India are significantly high, as also the frustrations and time taken. This is the result of a control-mindset, mistrust and lack of administrative productivity that governance in India has traditionally had. Innovation, across all areas of the economy, has never been at the centre of policy measures and the emphasis has been on balancing books and on fiscal aspects. I would look forward to these aspects being given due attention in the forthcoming budget." Science ignored repeatedly The previous budgets in India have not been able to provide much succour to the science and the industries that develop products based on it. Perhaps the reason is that in a populous country with volatile borders, there are other priorities such as defence, transportation and infrastructure which get maximum attention. Dr Shama Bhat is of the opinion that it is always the social issues that take priority over other issues. "So the budget cuts are always on science, which are not on the priority list for politicians," he said. Mr Ravi Dawar felt that the GST roadmap and details of roll out need to be given attention in upcoming budget. He opines that since it was a difficult time last year, and the finance minister was only 45 days into the job when he presented the budget, so last year's budget need not be judged for expectations from the upcoming budget. He added, "I am hopeful that we will see increased funding in S&T. Further, with inflation significantly tempered from last year rates, the quantum of funding in real terms will be higher." According to Mr Subbarao Appemane, "Fifty percent of our population is dependent, needs greater attention to encourage investments. Previous budgets have been only partly addressing these requirements. Any government will have limited resources to allocate and but there would be many priorities to focus on. In its considered wisdom, each government sets it priorities in allocating the available limited resources. Submission from our sector is that given the size of the population engaged in agriculture and the cascading effect that the agricultural growth has on the economy, it should be amongst top priorities." Dr Arvind Kapur feels that the reasons are obvious and that is most of the innovations are coming from outside. "And the local industry is not investing in research in S&T and health due to higher cost of finances and incentives given for investments in R&D are too meager and carry high risk of failure. If new government gives more funds with low or no interest for research, the innovation will increase in India," he said. "First and foremost, we are a nation that traditionally has not encouraged scientific inquiry. Our school and university system delivers learning as given, does not provide for experimentation and discourages questioning by pupils," said Mr KV Subramaniam while adding further, "All these undermine the scientific temperament. Over time, the Indian society has placed less emphasis on enterprise and more on employment. Then there are competing priorities in the social sector for limited resources that are available and a 'please all' attitude, which result in spreading resources a mile wide and an inch deep. Patronage thus takes over purpose. The health sector has failed because of serious infirmities in public health and grassroots primary health care efforts." While the agriculture sector might receive the increased funding, the allocations for scientific agencies will have to be watched closely. Also, the fingers are crossed on the percentage increase from 1.3 to 2 in health budget vis a vis GDP of the country. Whether or not there will be new tax rebates on drug imports and exports too would be eagerly awaited alike. One thing is clear this time. Industry is banking high on the renewed optimism and far from mere promises; it requires some visible encouragement from the government. ]]> <![CDATA[Global AF treatment market to peak at $9.4 bn in 2020]]> https://biospectrumindia.com/news/95/5510/global-af-treatment-market-to-peak-at-9-4-bn-in-2020.html https://biospectrumindia.com/news/95/5510/global-af-treatment-market-to-peak-at-9-4-bn-in-2020.html Fri, 27 Feb 2015 09:14:00 +0530 NOACs have seen substantial uptake since the launch of Pradaxa in 2010, with the drugs accounting for approximately 70% of all AF therapeutics sales in 2013. Dr Haylyn Wong, GlobalData's senior analyst covering cardiovascular & metabolic disorders, said that, the increased adoption of NOACs will be the primary driver of market growth across the eight major markets, comprising of the US, France, Germany, Italy, Spain, UK, Japan, and Canada, over the forecast period. Dr Wong explained: "Prior to the approval of the first NOACs, namely Pradaxa, Xarelto and Eliquis, the anticoagulant market for the prevention of stroke in AF patients was dominated by generic vitamin K antagonists, particularly warfarin. "However, GlobalData expects that the advances offered by NOACs in terms of improved safety and the lack of a need for routine monitoring will see these treatments taking market share away from warfarin." The analyst remarked that the AF therapeutics market will also be driven by the recent launch of a fourth NOAC, Daiichi-Sankyo's Savaysa, which will provide an additional anticoagulant treatment option for AF patients. "NOACs are also expected to be used as an alternative to antiplatelet therapy, particularly aspirin use, which has historically been prescribed for AF patients with a low risk of stroke. This is due to revised AF treatment guidelines downgrading the use of aspirin and a lack of evidence for the product's efficacy in preventing stroke in these patients," Dr Wong added. "Additionally, the antiarrhythmic drugs ranolazine/dronedarone and vanoxerine, developed by Gilead and ChanRx, respectively, are expected to launch late in the forecast period. However, neither will reach peak sales by 2023, with only ranolazine/dronedarone making an early impact as a potential drug candidate for the maintenance of sinus rhythm," the analyst concluded. ]]> <![CDATA['Every Individual has a right to live']]> https://biospectrumindia.com/news/95/5512/every-individual-has-a-right-to-live.html https://biospectrumindia.com/news/95/5512/every-individual-has-a-right-to-live.html Thu, 26 Feb 2015 15:02:55 +0530 There are an estimated 6,000-7,000 rare diseases which have been identified, of which for only 500 diseases treatment is currently available. As per WHO estimates, India has 70 million rare disease patients. Still, no significant research is happening in this area. "Given the huge burden of rare diseases we have in India, there is an urgent need to invest in clinical research that ensures that patients have access to new drugs and treatment which research makes possible," said Dr Vikas Sharma, member, Ethics Council, Indian Society for Clinical Research (ISCR). He was speaking at an event organized by ISCR on the occasion of World Rare Disease Day, which falls on February 28. Due to the lack of awareness even among the medical fraternity, rare diseases generally take a long time to diagnose. Lack of availability of treatment and high costs (for available ones) poses another challenge. "Awareness, accessbiliy and affordability are the key needs of patients suffering from a rare disease and an early diagnosis is a critical challenge in the management of rare disease," said Dr Prasanna Shirol, founder, Organisation for Rare Diseases India (ORDI), and whose daughter has a rare disease called Pompe. Stressing the need for clinical research in rare diseases, Dr Suneela Thatte, president, ISCR said, "India has 17 percent of the world's population, 20 percent of the highest disease and yet less than 1.5 percent of the global trials take place in India. The number of trials in rare diseases as a percent of these is probably an even more insignificant number." Atleast if there is an clinical research happening that would provide a ray of hope for the patients and their families who generally lives in dark and have no idea about what to do, where to go. And also at times, it has been helpful in improving the condition of these patients. One such example is Mr Ram G Vallath, an entrepreneur, motivational speaker and author. He suffers from an auto-immune disorder CIPD, a rare disease. "I was fortunate to be able to participate in a stem cell clinical trial in the USA thanks to which my condition has improved significantly. Unfortunately, a majority of patients in India cannot afford the current line of treatment nor is there any access to clinical trails for CIDP in India. The life of these patients is therefore, one constant struggle and suffering," said Mr Vallanth. Another such example is of Mr Premroop Alva who was diagnosed with hemophilia at a very young age. He participated in a hemophilia clinical trial for a new treatment which offered a significant benefit over the existing line of treatment and the new drug is expected to be launched in India soon. "The chances of dying with influenza, was very high 100 years back but then research provided the solution. Research is important to reduce human suffering, we have to give the same amount of importance to every human disease. We need to provide an environment where it is easy to do innovation and research. If we have an environment which is conducive of scientific, ethical and relevant research, rare disease would also get benefitted," said Dr Vikas. "Today, the cost of treatment is high because the innovation took place in some other country. If we could invest in research in our own country, we can develop the treatment cheaply," he added. He also stressed on the needs of having an orphan drug policy for these diseases which will foster research in this area. Dr Prasanna further supported, "We need to create a strong system for rare diseases in India including a patient registry, a supportive national policy and regulatory environment. Patients suffering from rare diseases have an equal right to benefit from new medicines and treatment available to patients in other parts of the world." "It is not about the statistics, because every individual has a right to live and every human being is important," he added. Thus, there is a need for greater amount of research for these rare diseases because ultimately it will help in reducing the disease burden of the country. ]]> <![CDATA["India plans to achieve improved results on MDG4"]]> https://biospectrumindia.com/news/95/5485/india-plans-to-achieve-improved-results-on-mdg4.html https://biospectrumindia.com/news/95/5485/india-plans-to-achieve-improved-results-on-mdg4.html Thu, 26 Feb 2015 13:09:34 +0530 The Reproductive, Maternal, Newborn, Child, and Adolescent Health (RMNCH+A) coalition in collaboration with Save the Children and White Ribbon Alliance of India organized a day-long National CSO Consultation on 'Post 2015 Sustainable Development Agenda and the Global Strategy for Women's, Children's and Adolescent Health'. The event was held at Delhi on February 25, 2015. Presenting at the consultation, the joint secretary for ministry of health and family welfare, Dr Rakesh Kumar mentioned, "India has made considerable progress on MDGs 4 & 5 with the introduction of NRHM and NUHM. 10 Indian states have already achieved the MDG 4 targets. However, we recognize that neonatal mortality, pneumonia and diarrhea continue to be leading causes of Under-5 deaths in India, attributing to about 80 percent of the overall under-5 mortality. With interventions such as continuum of care, reaching the unreached, improving quality of care, introduction of 3 new pediatric vaccines in the Universal Immunization Program, Project Indradhanush, Corticosteroids injections, roll out of the Integrated Action Plan for Pneumonia and Diarrhoea prevention across 4 key States of UP, Bihar, Madhya Pradesh and Rajasthan, India plans to achieve improved results on MDG4. India has seen a 61 percent decline in Under-5 mortality rate since 1990, higher than the global average." The event saw representation from the Ministry of Health & Family Welfare, United Nations (UN), World Health Organisation, CHETNA, Pathfinder, World Vision and The Partnership for Maternal, Newborn & Child Health, Center for Catalyzing Change. Commenting on the importance and need for this National Consultation, Ms Shireen Vakil Miller, head of Policy, Save the Children said, "India has made dramatic progress in bringing the under-5 mortality from 114 in 1990 to 50 per 1000 live births in 2012, showing a commendable decline of 58 percent. Yet, India also represents some of the greatest challenges like inequity in seeing this revolution through. India has persistently high rates of newborn mortality and accounts for 27 percent of all newborn deaths globally, with 78,5000 newborn deaths a year. This consultation is an attempt to incorporate learnings from MDGs so that the post-2015 development goals are more comprehensive and with equity as the bedrock." Describing the role of civil society organizations in participation, inclusion and transparency in driving the Global Strategy for Women's and Children's Health, Dr Flavia Bustreo, assistant director-general, Family, Women's and Children's Health, World Health Organization, said, "Civil society represents citizen voices, provide platforms for information sharing with community and for advocacy. Civil Society Organizations play a critical role in budget tracking and advocating adequate spending to achieve improved child and women health indicators." "It is imperative that civil society engages in the setting up of the post 2015 agenda since progress can be accelerated through citizen engagement at every level of the health system and by ensuring responsiveness to deliver on commitments," reiterated Dr Aparajita Gogoi, the National Coordinator of WRAI. The Global Strategy for Women's and Children's Health launched in September 2010 by the UN Secretary-General, has contributed to significant progress worldwide for women's and children's survival and health. The Every Woman Every Child movement that grew out of the Global Strategy mobilized actors from all sectors to work towards shared goals. Strong progress has been made toward the vision to end all preventable maternal, newborn, child, and adolescent deaths within a generation but there is still unfinished business and new challenges that need to be addressed as we transition from the Millennium Development Goals to the Sustainable Development Goals agenda. In November 2014, Every Women Every Child stakeholders unanimously agreed on the need to update the Global Strategy as a roadmap for taking forward the unfinished MDG agenda and women's, children's and adolescent health related Sustainable Development Goals. An updated Global Strategy will build on new evidence, including the need to focus on critical population groups such as newborns, adolescents and those living in fragile and conflict settings, build the resilience of health systems, improve the quality of health services and equity in their coverage, and work with health-enhancing sectors on issues such as women's empowerment, education, nutrition, water, sanitation and hygiene. It will align with the targets and indicators developed for the Sustainable Development Goals framework and outline opportunities for means of implementation, including innovative financing. This National Consultation aims to ensure India focused inputs into the Global Strategy based on perspectives from the civil society organizations. The recommendations gathered as a result of today's discussions will be presented at the International Consultation being organised later this week by the Government of India and Every Woman Every Child initiative. ]]> <![CDATA[Glenmark conferred 'Greentech Environment Gold Award 2015']]> https://biospectrumindia.com/news/95/5447/glenmark-conferred-greentech-environment-gold-award-2015.html https://biospectrumindia.com/news/95/5447/glenmark-conferred-greentech-environment-gold-award-2015.html Thu, 26 Feb 2015 12:44:28 +0530 Two manufacturing facilities of Glenmark located in Goa and Nashik have bagged the 'Greentech Environment Gold Award 2015' for excellence in environment management. Greentech Environment Awards given by the Greentech Foundation are presented ever year to companies/units demonstrating highest level of commitment to environmental management across different sectors. "The coveted Gold Accolade from Greentech Foundation is a testament of our commitment towards Environment Protection. We are dedicated to conducting our business responsibly in the area of Environment, Health and Safety across all our operations. At our Goa and Nashik plants, we have taken a number of steps in conserving natural resources, preventing pollution and minimizing environmental impact which has resulted into this award," said Ms Cheryl Pinto, director corporate affairs, Glenmark. Glenmark's manufacturing facility in Goa manufactures oral solids, semi solids and hormones. It is approved by regulatory bodies like US FDA, TPD (Canada), MCC (South Africa), WHO-GMP, ANVISA (Brazil) and MHRA (UK). The Nashik facility which began operations in the year 1983 is Glenmark's first manufacturing facility. The facility manufactures more than 200 products catering to the bulk of the demand for solid orals, liquid orals, and external creams and powders in over 70 markets in Asia [including India], Africa, CIS/Russia, and Latin America. ]]> <![CDATA[Growth hormone therapy market favors biobetters over biosimilars]]> https://biospectrumindia.com/news/95/5444/growth-hormone-therapy-market-favors-biobetters-over-biosimilars.html https://biospectrumindia.com/news/95/5444/growth-hormone-therapy-market-favors-biobetters-over-biosimilars.html Thu, 26 Feb 2015 09:26:00 +0530 The lack of biosimilars in the growth hormone deficiency (GHD) treatment pipeline does not signify a missed opportunity, because superior products exist in the form of next-generation biologics known as biobetters, says an analyst with research and consulting firm GlobalData. According to Dr Lakshmi Dharmarajan, GlobalData's analyst covering Cardiovascular & Metabolic Disorders, all the drugs currently in late-stage development for GHD in the seven major markets, namely the US, France, Germany, Italy, Spain, UK, and Japan, are long-acting growth hormone (GH) drugs, or GH biobetters. Dr Dharmarajan explained, "Despite the patent expirations of the originator drugs, there are no biosimilars in the GHD treatment pipeline. Instead, long-acting GH biobetters will have an increased chance of market uptake upon entry, as they address the unmet need for improved compliance while offering a clinical advantage over their predecessors. "Additionally, biobetters can be approved through the established regulatory pathways, whereas the biosimilar guidelines are still somewhat murky. While GH biobetters require more time and investment for development, the net payoff is higher when they are marketed due to their premium pricing." On the other hand, high biobetter prices could facilitate the adoption of GH biosimilars, because these products are expected to significantly reduce treatment costs. However, the analyst cites the case of Sandoz's Omnitrope, the only currently-marketed GH biosimilar, as evidence that drug uptake in this treatment space relies on more than just price and is influenced by factors such as delivery options, patient assistance programs, and company rebates to payers. Dr Dharmarajan continued, "Omnitrope was the first biosimilar to be approved in the global pharmaceutical space and despite having a 30% lower price than Pfizer's Genotropin (somatropin [rDNA origin]), the drug initially failed to penetrate the GHD treatment market. "After Sandoz re-strategized the Omnitrope brand and introduced improved delivery options and newer formulations, the biosimilar giant was able to make inroads into the market, albeit very gradually. Nevertheless, the originator drugs continue to dominate the arena in terms of patient share." The analyst concludes that to compete in such a market, biosimilar manufacturers must make a substantial investment comparable to that for the originator drugs in order to build their biosimilar brand value, a risk that only the larger pharmaceutical companies can afford to take. ]]> <![CDATA[Lupin, Celon announce strategic agreement ]]> https://biospectrumindia.com/news/95/5250/lupin-celon-announce-strategic-agreement-.html https://biospectrumindia.com/news/95/5250/lupin-celon-announce-strategic-agreement-.html Wed, 25 Feb 2015 13:53:37 +0530 This dry powder is the generic version of GlaxoSmithKline's (GSK) Advair Diskus. Lupin will be responsible for commercialization of the product. Celon will supply the product to Lupin for its commercialization in the United States, Canada, Mexico, and other key markets. Commenting on the development, Lupin's CEO Ms Vinita Gupta voiced, "This collaboration is an important milestone in Lupin's efforts to evolve its global inhalation pipeline. We are very pleased to partner with Celon given their experience in the development and manufacturing of fluticasone/salmeterol DPI in Europe. This coupled with Lupin's expertise in inhalation product development and commercialization in the US and other markets will accelerate the development of generic Advair Diskus for global markets. We look forward to providing access to high quality, affordable fluticasone/salmeterol DPI as part of our strategy to deliver inhaled products to key markets." GSK's Advair Diskus had global sales of over $7 billion as of last fiscal. Celon's CMD Dr Maciej Wieczorek opined, "Our scientific and technical teams look forward to collaborating with Lupin to bring this product to major markets outside of Poland. We are enthusiastic and believe that both the companies would work together to complete a time bound R&D program to ensure successful registration in targeted markets, for Lupin to effectively commercialize the product." ]]> <![CDATA[India, UK partner to fund multimillion research centers]]> https://biospectrumindia.com/news/95/5205/india-uk-partner-to-fund-multimillion-research-centers.html https://biospectrumindia.com/news/95/5205/india-uk-partner-to-fund-multimillion-research-centers.html Wed, 25 Feb 2015 12:13:19 +0530 Using high quality research teams based in the UK and India, two of the centers will focus on research into antimicrobial resistance (AMR), and the other on cancer biology. Nearly £3.5million will be invested by UK, through the MRC and the Newton Fund, with matched funding provided by DBT. The centers will take a global perspective in tackling some of the largest global health problems of today and foster the next generation of researchers with specialist skills. The Cambridge-Chennai Center Partnership on Antimicrobial Resistant Tuberculosis: A team of international researchers, from across a number of disciplines, will look to develop new diagnostic tools and new treatments to address the sharp rise in cases of multidrug resistant Tuberculosis (MDR-TB). The partnership between the University of Cambridge and the National Institute for Research in Tuberculosis (NIRT) in Chennai, India, will generate a rich and lasting clinical and genomic dataset. UK-India Center for Advanced Technology for Minimising the indiscriminate use of Antibiotics (UKICAT-MA): This center will focus on finding solutions to the excessive and inappropriate use of antibiotics. In partnership with the University of Sheffield, University of Bradford and L V Prasad Eye Institute in India, the new center will establish smart materials for the detection and targeted delivery of antibiotics for eye infections, and promote the use of these new technologies in other infective diseases. MRC-DBT Joint Centre for Cancer Biology & Therapeutics: Cancer is among the leading causes of disease and death worldwide. The World Health Organization estimates that the number of new cases will rise by about 70 percent over the next two decades. This center will link the MRC Cancer Unit at the University of Cambridge with the National Center for Biological Sciences in India to foster research on cancer biology and therapy through collaborative research programs, translational research and capacity building. As per Prof. K VijayRaghavan, secretary, Department of Biotechnology, "The Department of Biotechnology, Government of India is delighted to partner with the MRC in creating research centers which will address vexing challenges in medicine through quality science and collaboration. India is committed to working with the best in the world, for India and for the world. We are acutely aware that the fruits of our partnership can mean better lives for the most-needy everywhere and are committed to make the collaboration succeed." In his statement, Dr Mark Palmer, director of International Strategy, MRC mentioned, "With a 100-year history of strategic international collaboration, MRC scientists today collaborate with researchers in more than 100 countries. We know diseases don't recognise international borders and that addressing health problems around the world demands a global response. These exciting partnerships between excellent scientists in India and the UK is a key part of our international effort to pool expertise and resources and deliver research that will make a real difference to global health." ]]> <![CDATA[Novartis' blood cancer drug gets FDA nod]]> https://biospectrumindia.com/news/95/5155/novartis-blood-cancer-drug-gets-fda-nod.html https://biospectrumindia.com/news/95/5155/novartis-blood-cancer-drug-gets-fda-nod.html Wed, 25 Feb 2015 12:08:54 +0530 Novartis has announced that the US Food and Drug Administration (US FDA) has approved Farydak (panobinostat, previously known as LBH589) capsules in combination with bortezomib and dexamethasone. It has been approved for the treatment of patients with multiple myeloma who have received at least two prior regimens, including bortezomib and an immunomodulatory (IMiD) agent. Farydak has been shown to extend the progression-free survival (PFS) benefit of the standard-of-care therapy in this patient population. It was approved under accelerated approval based on PFS. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. The FDA has approved a risk evaluation and mitigation strategy (REMS) for Farydak. This FDA approval is based on efficacy and safety data in a pre-specified subgroup analysis of 193 patients who had received prior treatment with both bortezomib and an IMiD during the Phase III, randomized, double-blind, placebo-controlled, multicenter global registration trial, called PANORAMA-1 (PANobinostat ORAl in Multiple MyelomA). The trial found that the median PFS benefit increased in Farydak patients who had received prior treatment with both bortezomib and an IMiD (10.6 months; n=94), as compared to the placebo arm (5.8 months; n=99) (hazard ratio=0.52 [95 percent confidence interval (CI): 0.36, 0.76]). The most common adverse reactions (incidence >= 20 percent) in clinical studies are diarrhea, fatigue, nausea, peripheral edema, decreased appetite, pyrexia and vomiting. The most common non-hematologic laboratory abnormalities (incidence >= 40 percent) are hypophosphatemia, hypokalemia, hyponatremia and increased creatinine. The most common hematologic laboratory abnormalities (incidence >= 60 percent) are thrombocytopenia, lymphopenia, leukopenia, neutropenia, and anemia. "Novartis is committed to developing innovative first-in-class therapies for patients who need treatment options. Farydak represents a new drug class in multiple myeloma, providing these patients with an important treatment approach for this difficult-to-treat cancer," said Mr Bruno Strigini, president, Novartis Oncology. ]]> <![CDATA[Govt to deal firmly with those exporting spurious drugs]]> https://biospectrumindia.com/news/95/7332/govt-to-deal-firmly-with-those-exporting-spurious-drugs.html https://biospectrumindia.com/news/95/7332/govt-to-deal-firmly-with-those-exporting-spurious-drugs.html Wed, 25 Feb 2015 11:55:52 +0530 While making a statement in Parliament on February, 24, 2015, on the issue of export of spurious drugs, Mr JP Nadda, union health minister gave details of the steps taken by the government to curb it. His detailed statement mentioned that isolated cases of export of drugs of sub-standard quality by some Indian pharmaceutical companies have appeared in the media and on the websites of the regulatory authorities of foreign countries, etc. from time to time. These include the websites of United State Food and Drugs Administration and Medicines and Healthcare Products Regulatory Agency, United Kingdom. Based on the samples taken by Central Drugs Standard Control Organization during 2011-12 to 2014-15 (up to September, 2014), 0.03% samples were found to be spurious or adulterated and 3.33% samples were found to be not of standard quality. Such medicines are not allowed to be sold either in the domestic or in other markets. Samples are drawn by the officers of the Central Drugs Standard Control Organization (CDSCO) and State Drug Regulatory officials regularly and these are tested at the drug testing laboratories. In cases, where samples are not found to be conforming to quality, appropriate action is taken by the State Drug Regulators. These include suspension, cancellation, rejection or debarment of the license. In order to check the problem of spurious/sub-standard drugs in the country, a number of steps have been taken by the Government. These include amendment to the Drugs and Cosmetics Act, 1940 which provides for stringent penalties for manufacture of spurious and adulterated drugs. Through that amendment, some offences have also been made cognizable and non-bailable. Further, 21 States/UTs have already set up Special Designated Courts for trial of such offences and the structures in the CDSCO have also been strengthened. Black marketing of life saving drugs Mr Nadda also revealed that health ministry does not have any information about black marketing of drugs. However, the State Drug Controllers are empowered under the Drugs & Cosmetics Act, 1940 and Rules thereunder for initiating action against such unauthorized activities. The health minister elaborated, "Pricing of drugs is dealt with by the Department of Pharmaceuticals. As per information provided by that Department, 51 cancer medicines are included in the scheduled category of Drugs Price Control Order (DPCO) out of which National Pharmaceutical Pricing Authority has already notified the ceiling prices of 47 cancer medicines. No person is authorized to sell formulations at a price higher than the ceiling price of scheduled formulations fixed under DPCO, 2013. In respect of non-scheduled formulations, not covered under price control, manufacturers are not allowed to increase the price beyond the permissible limit of ten percent on a year to year basis under the provision of DPCO, 2013." ]]> <![CDATA[Jubilant receives ANDA approvals for key products]]> https://biospectrumindia.com/news/95/5168/jubilant-receives-anda-approvals-for-key-products.html https://biospectrumindia.com/news/95/5168/jubilant-receives-anda-approvals-for-key-products.html Wed, 25 Feb 2015 11:54:05 +0530 Irbesartan Tablets USP, 75 mg, 150 mg, and 300 mg is the generic version of Avapro® (of Sanofi-Aventis), which is used for treating hypertension and nephropathy in type II diabetic patients. The total market size for Irbesartan Tablets as per IMS is approximately $50 Million per annum. Cetirizine Hydrochloride Tablets (Chewable), 5 mg and 10 mg is the generic version of Zyrtec Chewable Tablets® (of Mcneil), used as an anti-histamine for the treatment of allergies. As on December 31, 2014, Jubilant Life Sciences had a total of 781 filings for formulations of which 333 have been approved in various regions globally. This includes 72 ANDAs filed in the US, of which 35 have been approved and 46 Dossier filings in Europe. So far, we have received 9 ANDA approvals during FY 2015. ]]> <![CDATA[Dr Rowinsky joins Mitra Biotech's scientific advisory board]]> https://biospectrumindia.com/news/95/4958/dr-rowinsky-joins-mitra-biotechs-scientific-advisory-board.html https://biospectrumindia.com/news/95/4958/dr-rowinsky-joins-mitra-biotechs-scientific-advisory-board.html Tue, 24 Feb 2015 13:01:01 +0530 "I am very excited to be working Mitra Biotech. I am impressed with the extensive clinical validation of CANScript, and believe that it will be a highly-useful tool for cancer patients as well for companies developing oncology therapeutics," said Dr Eric. Dr Eric Rowinsky was previously the chief medical officer for ImClone Systems. He is currently the chief medical officer and head of research and development of Stemline Therapeutics. He also currently serves on the board of directors of Biogen Idec, as well as several other public biopharmaceutical companies. He is also Editor-in-Chief of Investigational New Drugs (The Journal of New Anticancer Agents). "We are honored to work with Dr Rowinsky," said Dr Mallik Sundaram, CEO of Mitra. "Dr Rowinsky's extensive knowledge of oncology drugs and personalized medicine, as well as his broad expertise with cancer clinical trials, will certainly prove valuable to Mitra as we continue to develop and grow CANScript platform in the theranostics and drug development arenas. We are particularly pleased at the timing as Mitra is in discussions with USFDA with regards to pivotal clinical trials leading to commercialization of CANScript in the US market." ]]> <![CDATA[Intas becomes first Indian firm to launch biosimilars in EU]]> https://biospectrumindia.com/news/95/6608/intas-becomes-first-indian-firm-to-launch-biosimilars-in-eu.html https://biospectrumindia.com/news/95/6608/intas-becomes-first-indian-firm-to-launch-biosimilars-in-eu.html Tue, 24 Feb 2015 13:00:20 +0530 Intas became the first Indian company to launch a biosimilar in highly regulated markets like EU, the US and Japan. The company on February 23, 2015 announced that they have launched their first biosimilar, Filgrastim, in Europe, through their wholly owned subsidiary Accord Healthcare. The product has recently been introduced under the brand Accofil and has already won two prestigious tenders, in Netherlands and the UK respectively. In addition, Intas is also the only company from India to have two of its products, filgrastim and peg-filgrastim filed for registration in the US, through its collaboration partner. Accofil® is a biosimilar product of Neupogen (filgrastim) and will offer patients cost effective therapy that is comparable in quality, safety and efficacy. Accofil® is indicated for the treatment of reduction in the duration of neutropenia and the incidence of febrile neutropenia, mobilization of peripheral blood progenitor cells, severe congenital, cyclic, or idiopathic neutropenia and persistent neutropenia in patients with advanced HIV infection. Mr Binish Chudgar, Vice-chairman of the company said, "The launch of our filgrastim in Europe is another demonstration of our commitment to global healthcare at affordable prices. Accofil (filgrastim), which was developed at our own laboratories and manufactured at our own cGMP approved site in Ahmedabad, showcases our expertise in biopharmaceutical development and its manufacture. This is only the first of many biological products that we will launch in EU and other regulated markets over the next few years." Intas is one of the pioneers and market leaders of biosimilars in India, having launched its first product in the domestic market in 2004. The company has eight biosimilar products in the market, including one monoclonal antibody MABTAS (rituximab), the largest indigenously development portfolio of biosimilar products. The company also has one of the richest pipeline of future products, that will enable it to continue to provide cost effective biosimilar alternates to imported and expensive biologic therapies, for the Indian population. Intas is the first company in India to have its biologics manufacturing facility accredited by the European Health Authority. ]]> <![CDATA[Ranbaxy & APICON create biggest heart for Guinness world record]]> https://biospectrumindia.com/news/95/4874/ranbaxy-apicon-create-biggest-heart-for-guinness-world-record.html https://biospectrumindia.com/news/95/4874/ranbaxy-apicon-create-biggest-heart-for-guinness-world-record.html Tue, 24 Feb 2015 10:56:52 +0530 The Ranbaxy Laboratories and APICON 2015 ( 70th Annual Conference of Association of Physicians of India ) on 20th February, 2015, broke the " Guinness World Record ' for making the largest human image of heart in Gurgaon, Haryana. Realizing the need for proactive emphasis on the preventive healthcare and raising awareness on heart disease in India, Ranbaxy and APICON assembled about 982 people including employees and doctors. The award, constituted 7 years ago ,is given in recognition of the efforts undertaken by the companies to address the social, economic and environmental effects of doing business, while balancing demands on their attention, time and resources. The task was completed in 1 hour and 15 minutes. The participants wore T shirts and caps of distict colors to bring about the correct anatomical representation of this central body organ. Creation beat the largest ever human organ being made by humans assembled together. The earlier record was set on February, 20, 2014 in Liverpool, UK by 687 people who came together to create a human brain on World Encephalitis day. ]]> <![CDATA[Advaxis completes $23 Mn financing]]> https://biospectrumindia.com/news/95/4803/advaxis-completes-23-mn-financing.html https://biospectrumindia.com/news/95/4803/advaxis-completes-23-mn-financing.html Mon, 23 Feb 2015 15:01:41 +0530 Advaxis, a clinical-stage biotechnology company developing cancer immunotherapies, announced that it has executed definitive securities purchase agreements with several institutional investors for gross proceeds of approximately $23 million in a registered direct offering of approximately 3.1 million shares at a price of $7.50 per share. The pricing on this transaction reflects the at-the-market closing price on February 17, 2015. Adage Capital Management, Broadfin Capital LLC, Sectoral Asset Management, Cormorant Asset Management and certain funds and accounts managed by T Rowe Price Associates. participated in this financing along with another institutional investor. Following the close of the transaction, Adage will own approximately 19% of the outstanding shares of Advaxis. Proceeds from this financing will be used primarily to fund the continued clinical development of Advaxis's cancer immunotherapy pipeline. ]]> <![CDATA[Jubilant wins ASSOCHAM's responsible organization award 2015]]> https://biospectrumindia.com/news/95/4799/jubilant-wins-assochams-responsible-organization-award-2015.html https://biospectrumindia.com/news/95/4799/jubilant-wins-assochams-responsible-organization-award-2015.html Mon, 23 Feb 2015 13:50:31 +0530 The Jubilant Life Sciences, an integrated global pharmaceutical company has emerged as the winner of this year's most responsible organization excellence award 2015 conferred by ASSOCHAM. The award, constituted 7 years ago, is given in recognition of the efforts undertaken by the companies to address the social, economic and environmental effects of doing business, while balancing demands on their attention, time and resources. The award chaired by Justice VN Khare is a part of rigorous five stage selection process. The award was presented by Mrs Nirmala Sitharaman, on Feb 20, 2015 to Mr Shyamsundar Bang, executive director, manufacturing and supply chain, Jubilant Life Sciences. Expressing his happiness on receiving the award, Mr Bang stated, "We are elated on receiving this prestigious award. It is a recognition of our efforts and reflects our commitment towards the society. " ]]> <![CDATA[H1N1 situation: no shortage of drugs says govt]]> https://biospectrumindia.com/news/95/5998/h1n1-situation-no-shortage-of-drugs-says-govt.html https://biospectrumindia.com/news/95/5998/h1n1-situation-no-shortage-of-drugs-says-govt.html Sun, 22 Feb 2015 12:07:00 +0530 With rise in number of swine flu cases and deaths reported across India, the health ministry in a high level meeting chaired by the health secretary, Mr B P Sharma took a review of the situation. So far, there are close to 670 persons reportedly dead due to H1N1 influenza virus and 10,000 positive cases. The meeting that took place on February, 17, 2015, was also attended by the director general, health services, Dr Jagdish Prasad alongwith Dr G N Singh, drug controller general of India discussed the measures being taken to tackle the situation. It was attended by the representatives of various leading hospitals and Indian Council of Medical Research (ICMR). The state governments too took a part through video conferencing. The availability of drugs, testing kits, diagnostic labs, Personal Protective Equipment (PPE), masks etc is being continuously reviewed through video conferencing and telephonic means. As per health secretary, the states have not projected any need in this regard. All necessary and requested help is being provided to the states to augment their capacity. In case of need, labs under ICMR have been identified across the country to provide additional testing facilities. Also, Delhi has started a new testing facility at AIIMS. A 24 x7 Monitoring Cell is in operation at the National Centre for Disease Control ( NCDC ). Teams of experts from the Health Ministry have visited states of Telangana, Gujarat and Rajasthan to extend technical support. Two such teams have been also sent to Madhya Pradesh and Maharashtra. States have been asked to study the patterns in mortality such as which areas, age groups and section of people who have been affected, in addition to deaths due to morbid conditions. The guidelines framed by the Centre for vaccination of healthcare workers have been approved and provided to the states for dissemination. ]]> <![CDATA['Global Bio-based Biodegradable Plastics Market to grow rapidly']]> https://biospectrumindia.com/news/95/4320/global-bio-based-biodegradable-plastics-market-to-grow-rapidly.html https://biospectrumindia.com/news/95/4320/global-bio-based-biodegradable-plastics-market-to-grow-rapidly.html Sun, 22 Feb 2015 10:12:00 +0530 Future Market Insights (FMI), in its latest report states that the global bio-based biodegradable plastics market is expected to demonstrate a double-digit Compounded Annual Growth Rate (CAGR) during forecast period 2014-2020. Global penetration of biodegradable and bio-based biodegradable plastics is currently significantly lower in comparison to traditional fossil fuel-based plastics. Of the 300 million metric tonnes of plastics consumed in 2013, biodegradable plastics accounted for 0.21 percent of the total consumption. The total consumption of bio-based biodegradable plastics was 591,000 metric tonnes in 2013, accounting for 0.1 percent share of the total global plastics consumption. "Consumption of bio-based biodegradable plastics is substantially low compared to fossil fuel-based plastics, but this is expected to grow rapidly over the next five years. By 2020, the total revenue of the global bio-based biodegradable plastics market is expected to grow two and half times as compared to 2014," said Mr Essien Jae, lead consultant at FMI. Europe leads the global bio-based biodegradable plastics market, followed by North America. The market in Latin America is expected to demonstrate the highest growth rate at a CAGR of 22.6 percent, followed by Asia Pacific at a CAGR of 20.7 percent in terms of value. The cumulative market share of Latin America and Asia Pacific is anticipated to improve by around 400 basis points by the end of the forecast period. In terms of application, the packaging sector accounts for the largest share of the global bio-based biodegradable plastics market and is largely driven by Europe. Other key application sectors include fibres, agriculture and medical. ]]> <![CDATA[Medical experts demand ban on PET medicinal bottles]]> https://biospectrumindia.com/news/95/4220/medical-experts-demand-ban-on-pet-medicinal-bottles.html https://biospectrumindia.com/news/95/4220/medical-experts-demand-ban-on-pet-medicinal-bottles.html Sat, 21 Feb 2015 10:05:00 +0530 Medical experts from various medical institutions in Delhi on February 19, 2015, joined hands to press upon the ban on polyethylene terephthalate (PET) usage for certain medical formulations as notified by the Ministry of Health and Family Welfare within the stipulated timeframe in the wake of recent studies emanating on the various side effects. They condemned the latest move by the pharma industry to justify the use of PET bottle as safe and economical. Research has shown that medicines packed in PET bottles are a health hazard and can have adverse effect on children, women in their reproductive age and the geriatric population. The latest evidence suggests endocrine-disrupting chemicals found in PET bottles can cause early menopause in women. As per study published in PLoS ONE journal, women with the highest levels of these chemicals in their bodies went through menopause anywhere between two and four years earlier than women with the lowest levels. The study adds to a growing body of evidence linking so-called endocrine-disrupting chemicals to a range of effects in people such as cancer, recurrent abortions, and infertility. In a recent study published in a peer reviewed journal Carcinogenesis, it was found that terephthalic acid (TPA), a major chemical precursor of polyethylene terephthalate (PET) containers used for the storage of food and beverages, because of hormonal action increses the chances of breast cancer and also alters the response to breast cancer drugs. The study concluded that due to DNA damage the importance of human exposure to TPA, particularly at vulnerable life stages cannot be neglected. The matter has become so grave that the European Society for Paediatric Endocrinology and the Pediatric Endocrine Society alerted physicians to the possible dangers of endocrine-disrupting chemicals and encouraged them to participate in research on their effects. Experimental animal and wildlife studies have shown that such chemicals can function as disrupters of the endocrine systems, either by interaction with hormone receptors or with hormone production and metabolism. As per Dr Seema Singhal, Assistant Professor, Department of Obstetrics and Gynaecology, AIIMS, "PET bottles may have long term medical consequences for women, especially in the reproductive age group and children. The release of bisphenol A (BPA) and additives like di-ethylhexyl phthalate can blend with the contents and lead to health issues like impaired immune development, increased miscarriage rates, pre- term birth, low birth weight. BPA acts as a faux-estrogen, and can cause chromosomal abnormalities, birth defects and developmental disabilities in utero and childhood. Exposure to these faux-estrogens in uterus can cause early onset of puberty and increase the infant's risk of prostate or breast cancer as an adult. It may also affect the future fertility potential of a female fetus. BPA exposure is also linked with hyperactivity disorders and aggressive behaviors in young girls." In India, PET bottles are used in 70 percent pediatric and liquid geriatric formulations. And a great majority of pregnant women are unknowingly getting exposed by use of tonics or other medicines. In a recent study conducted by Texas university published in Environmental Health Perspectives, wherein it was found that even safest BPA free PET bottles leached and it showed that more than 70 percent of the products released chemicals that acted like estrogen. And that was before they exposed the stuff to real-world conditions: simulated sunlight, dishwashing and microwaving, Dr AP Dubey, professor and HoD Pediatrics, Maulana Azad Medical College said, "Women especially in the reproductive age group consuming medicine out of such bottles could have impaired immune development, loss of pregnancy, pre- term birth while children can suffer from low birth weight and congenital defects which could manifest in later stages of life. While the potential harmful effects of such toxins and chemicals is manifold, it is time our pharmaceutical and ancillary industry took the right cue from this government ordinance and minimized usage of plastics packaging for various liquid formulations. The new resolution by Government is really commendable as it keeps patient safety first." Indian Medical Association's former secretary, Dr Narendra Saini said that medical effects of plastic on human health cannot be ignored. As per Dr Saini, "The pharma industry uses amber colored glass bottles in certain instances to protect medicine from being exposed to UV light. However their usage is minimal. Also, many patients tend to ignore the shelf-life mentioned on PET containers and the temperature at which drugs need to be stored which could be harmful." PET bottles have been tested for permissible levels of phthalates, antimony, acetaldehyde etc., for storage at temperatures of around 20 degrees centigrade. This potential endocrine disruptor leaching, increases to as high as 4 times the permissible limit, at higher temperatures which are prevalent in our country. Prolonged storage beyond 120 days also results in toxic loading of the medication. A point to note is that prolonged storage also results (beyond 120 days) in toxic loading of the medication. Thus unnecessarily prolonging shelf life should also be discouraged. As per Prof. Dr Sanjeev Bagai, Padma Shree, senior consultant Paediatrician, vice chairman and director Dwarka Manipal Hospital, "A well-functioning endocrine system is necessary to regulate the release of certain hormones essential for functions such as metabolism, growth and development, sleep and mood. External agents can alter the function(s) of this hormonal system impacting the quality of life. Because most of the symptoms come on gradually, it is difficult to figure out initially, until the problems become more pronounced and the hormones become even more imbalanced." He added that exposure to endocrine disruptors found in PET containers can negatively impact the nervous system and lead to attention deficit or hyperactivity in children. Chemicals such as DHEP-plthalate are reasons for higher incidence of precocious puberty among young girls and genital abnormality among newborn babies." Mr Ajay Jugran, president, Him Jagriti said, "The plastic manufacturers and some of the pharmaceutical companies do not want the act to be passed and have written to the health ministry requesting them to reconsider their decision. This is very unfortunate." In September 2014, the government had proposed a ban on plastic (PET) containers as primary packaging in liquid oral formulations for paediatric, geriatric and reproductive healthcare use. The decision followed a PIL by HIM Jagriti, an NGO in public interest. The Government's directive to Pharmaceutical Industry also called for total ban on use of Plastic in medicines and medical equipment of all age groups as well as in all food and non-food items consumed by human beings. It also sought labeling of food & non-food items of human use as "SAFE FOR HUMAN USE.'' The doctors also said that studies in India should be started immediately to collect more data. Dr Kiran Agarwal, president, Indian Academy of Paediatrics, Delhi said, "The impact of such exposure may not be evident now but could manifest in the future, hence it is important to adopt safety measures as soon as early as possible. While we are hopeful that the government will go ahead and implement the ban, a lot could happen before then. Until then the health of a large section of the population remains compromised." Dr Prakash Trivedi, president, Federation of Obstetricians and Gynaecologists of India, "We urge upon the government to pass the Gazette & abolish use of Polyethylene Terephthalate or Plastic containers for primary packaging of drug formulations especially for pregnant women and in larger interest of general health of all." Allying the fears of some pharma companies of not having to have sufficient glass bottles in the event of the ban, the glass packaging industry have assured they are completely geared up to meet the demand of the pharma industry both in terms of quality and quantity. ]]> <![CDATA[IRI and Kline form exclusive alliance ]]> https://biospectrumindia.com/news/95/3536/iri-and-kline-form-exclusive-alliance-.html https://biospectrumindia.com/news/95/3536/iri-and-kline-form-exclusive-alliance-.html Fri, 20 Feb 2015 16:03:35 +0530 This powerful alliance will provide a higher level of data accuracy and an unparalleled, global range of thought leadership on stimulating topics in the consumer healthcare space. As part of this collaborative relationship, IRI will contribute its granular, widely recognized, point-of-sale (POS) market data, related insights, and thought leadership. "This exclusive alliance will help provide our clients an unprecedented level of actionable insights due to Kline's access to a global network of consumer healthcare specialists," said Mr Bob Sanders, executive vice president and healthcare practice leader, IRI. "IRI and Kline will be able to deliver unrivaled global thought leadership and consultation in the consumer healthcare space." Meanwhile, Kline will provide its unmatched historical database, global network, and 360-degree view of the complex OTC drug market, including its comprehensive channel coverage and vast expertise in the area of Rx-to-OTC switches. "Kline has been analyzing and serving the OTC pharmaceuticals market since the 1960s, and this arrangement is a natural evolution towards continuous improvement of service to our clients," said Ma Laura Mahecha, Industry Manager of Kline's Healthcare Practice. "By combining Kline's comprehensive market expertise with IRI's detailed data and technology tools, we can better serve our clients who seek comprehensive market information and insights." The collaborative thought leadership will manifest through white papers on such topics as Rx-to-OTC switch, merger, and acquisition activity and new product innovation, as well as trends and issues in international and emerging markets within the OTC drugs industry. ]]> <![CDATA[Sanofi inks autoimmune pact with Lead pharma]]> https://biospectrumindia.com/news/95/6184/sanofi-inks-autoimmune-pact-with-lead-pharma.html https://biospectrumindia.com/news/95/6184/sanofi-inks-autoimmune-pact-with-lead-pharma.html Fri, 20 Feb 2015 14:18:36 +0530 Sanofi has announced that it has entered into a research collaboration and license agreement with Dutch biotech Lead Pharma. The deal is to discover, develop and commercialise small-molecule therapies directed against the nuclear hormone receptors called ROR gamma t to treat a broad range of autoimmune disorders, including rheumatoid arthritis, psoriasis and inflammatory bowel disease, which are among the most common. "Anti-ROR gamma t therapies represent a ground-breaking opportunity that we are eager and motivated to pursue through our collaboration with Lead Pharma," said Mr Christian Antonio vice-president and head of the Immunology and Inflammation franchise, R&D, Sanofi. He added, "At Sanofi, we believe networked innovations, working collaboratively across science sectors, is the most effective way to bring meaningful new therapies to patients. To this end, Lead Pharma's innovative capabilities and productivity, exemplified by the ROR gamma t program, make them ideal partners for Sanofi in this area of drug discovery." Under the terms of the agreement, Sanofi and Lead Pharma will collaborate during the early phase of research and development with a goal of identifying drug candidates and begining human trials within 3-4 years. Lead Pharma will receive an upfront payment and is eligible to receive research, development, regulatory and commercial milestone payments. Sanofi will be responsible for clinical development and have worldwide marketing and commercialisation rights to any products that may be developed as a result of the collaboration. Lead Pharma is entitled to receive royalty payments on global sales from any such products. Financial details of the deal have not been disclosed. ]]> <![CDATA[Sanofi taps Bayer's healthcare head as new CEO]]> https://biospectrumindia.com/news/95/5560/sanofi-taps-bayers-healthcare-head-as-new-ceo.html https://biospectrumindia.com/news/95/5560/sanofi-taps-bayers-healthcare-head-as-new-ceo.html Fri, 20 Feb 2015 12:59:10 +0530 After firing Mr Chris Veihbacher in October last year, Sanofi names its new CEO and Mr Oliver Brandicourt, Bayer AG's healthcare head, is the man. Mr Brandicourt will join the Paris-based drugmaker from April 2, said Sanofi in a statement. Mr Serge Weinberg, chariman, Sanofi, said, "Mr Brandicourt is a very good fit for Sanofi and has the experience of the portfolio businesses we have," Mr Weinberg said in a conversation to Bloomberg. "A lot will be about launches, not only in 2015, and the US market is very high on the priority list," he said. The company had earlier said in a statement that they would find a new CEO with experience in handling the US market. The company also said that by 2020 it planned to launch 18 new products that could generate sales close to $34 billion in the next five years. Bayers' CEO, Mr Marjin Dekkers praised Mr Brandicourt for his commitment and contributions to the company. Mr Dekkers announced that Mr Werner Baumann, Bayer's chief strategy and portfolio officer, will succeed Mr Brandicourt as the healthcare head. ]]> <![CDATA[India accounts for 13% of global cancer burden: RTI]]> https://biospectrumindia.com/news/95/3389/india-accounts-for-13-of-global-cancer-burden-rti.html https://biospectrumindia.com/news/95/3389/india-accounts-for-13-of-global-cancer-burden-rti.html Fri, 20 Feb 2015 12:28:41 +0530 Research Triangle Institute India, one of the world's leading independent, nonprofit research and development organizations dedicated to improving the human condition hosted a two day Symposium on "Cancer Prevention in India" along with the American Cancer Society, Public Health Foundation of India (PHFI), Institute of Cytology and Preventive Oncology (ICPO), and Harvard Global Equity Initiative. The two day symposium brought together various bodies, both national and international, who collectively and collaboratively addressed various aspects of early detection and prevention of cancer in India. Speaking on the occasion, Dr Wayne Holden, president and chief executive officer, RTI International, "Since our inception we have been tirelessly working around the globe to create awareness about Non Communicable Diseases. Approximately 13 percent of the global burden of cancers-about 1 million new cases and more than 700,000 deaths annually-occur in India alone. Our work in over 75 countries has given us the edge to understand and address the burden of cancer more strategically and holistically. This symposium is aimed at creating a much-needed platform for all key stakeholders - government, health care providers, researchers, survivors, private sector, patient advocates, and foundations - to come together and thus take a fresh approach to address cancer prevention in India. I am delighted to see a diverse participation today representing all key stakeholder groups." Eminent personalities who participated in the symposium were Mr R Sankaranarayanan, World Health Organization, Ambassador Sally Cowal, American Cancer Society, Mr CK Mishra, Government of India, Mr MS Shanmugam, Government of Tamil Nadu along with other dignitaries from India and abroad. ]]> <![CDATA[Policymakers discuss role of technology in agriculture]]> https://biospectrumindia.com/news/95/6140/policymakers-discuss-role-of-technology-in-agriculture.html https://biospectrumindia.com/news/95/6140/policymakers-discuss-role-of-technology-in-agriculture.html Thu, 19 Feb 2015 16:28:44 +0530 Referring to â€œ Mera Gaon Mera Gaurav â€? programme, the agriculture minister, Mr Radha Mohan Singh urged experts of the agriculture universities and Indian Council for Agriculture Research ( ICAR) led institutes to create awareness about new technology to farmers, which will help farmers in knowing about new farming practices. He also suggested a thought towards an institutional mechanism of linkage between the KrishiVigyan Kendras ( KVKs) and Agriculture Technology Management Agency ( ATMA ) at district level. While addressing the annual general meeting of the ICAR Society, he emphasised about communications technologies ( ICTs ) for creating awareness about agriculture practice by using M - Kisan portal for sending information through SMSs, providing e - connectivity to KVKs, Kisan Chaupals, farmer's portals and Kisan Call Center. Dr Sanjeev Kumar Balyan, union minister of state for agriculture urged the scientists to strengthen the Lab - to - land programmes and enhance communication with the farmers. Mr Balyan expressed confidence that scientists and farmers through interactions, will develop new technologies. Mr Mohanbhai Kalyanjibhai Kundariya, union minister of state for agriculture emphasised about technological and knowledge empowerment of farmers through awareness creation via. Knowledge of latest know - how of technologies. The director general of ICAR, Dr M Ayyappan presented vote of thanks and highlighted the role of ICAR in creation of new technologies to improve agriculture practices. ]]> <![CDATA[TAKE's attempt to bring talented workforce to the market]]> https://biospectrumindia.com/news/95/4205/takes-attempt-to-bring-talented-workforce-to-the-market.html https://biospectrumindia.com/news/95/4205/takes-attempt-to-bring-talented-workforce-to-the-market.html Thu, 19 Feb 2015 15:11:30 +0530 Chennai: On 18 February, TAKE Solutions, a global business technology solutions provider, launched TAKE Academy of Life Science and Leadership (TALL) to cater to the talent needs of the lifesciences industry. TALL has been launched with the aim of creating a well-informed and industry-ready workforce that is competent in an era of transparency, collaboration, continuously transforming regulatory standards, and for enabling better healthcare for the global patient population. TALL will offer training programs to engineering and non engineering college students to enhance employability skills in the lifescience industry. TALL has collaborated with SRM University, Shasun Pharmaceuticals, and Tata Institute of Social Sciences (TISS). Both SRM and Shasun will provide student support to TALL and TISS will design the curriculum; provide training in quality control assessment; examination and certification to students inducted in TALL. The lifesciences industry is a knowledge industry that requires deep domain expertise, knowledge of emerging regulations, and strict enforcement of quality and compliance. The pace of change driven by increased automation leveraging cutting-edge technology solutions and mandates by global regulatory agencies for safer and more effective drugs at affordable healthcare costs is extremely high. The training needs of the existing and new workforce have to be addressed and TALL aims to deliver a differentiated curriculum to address this agenda. In an attempt to address the skill and knowledge gap in the lifesciences industry, TALL will work to enhance the proficiency of the existing workforce, enable technical expertise of students and will reach out to underprivileged youth to take up higher education through its 'Earn while you learn' scheme. TALL's hands-on approach to delivering industry-oriented curriculum along with providing candidates with the best of wet lab facilities as well as access to technology solutions via computer labs for real and practical experience to solving industry challenges will be its USP. The academy has adopted innovative teaching methodologies in physical and virtual classrooms, to impart skills as well as self-empowerment through leadership training. Addressing the media at the launch, Mr HR Srinivasan, CEO of TAKE SOLUTIONS, commented, "The paucity of skilled workforce in the lifescience sector has compelled us to launch this academy. As a service provider to the lifesciences industry, TAKE Solutions takes onus in creating talented human capital for the industry. This initiative will bridge the existing talent gap in the industry and will also contribute to strengthening India's position as a leading pharma market for foreign investors and partners." Speaking at the launch, managing director of Shasun Pharmaceuticals' Mr Abhaya Kumar said, "Shasun is the first pharma company in Tamil Nadu to enter into the sphere of strengthening talented workforce. This initiative will help fulfill Prime Minister Narendra Modi's 'Make in India' concept. The Indian pharma industry is undergoing a major transformation. Along with this transformation, a highly skilled workforce having knowledge in meeting global regulatory standards is imperative. TALL, I believe, will create a broader avenue to students who can hone their skills and increase their employability quotient." Mr Ram Yeleswarapu, president and CEO, TAKE Solutions said, "We have been serving the global lifesciences industry very effectively for well over a decade and now we aim to empower the workforce with knowledge and technologies that are shaping the trends of the future." ]]> <![CDATA[Lupin expands it's US brand portfolio]]> https://biospectrumindia.com/news/95/7313/lupin-expands-its-us-brand-portfolio.html https://biospectrumindia.com/news/95/7313/lupin-expands-its-us-brand-portfolio.html Thu, 19 Feb 2015 14:56:08 +0530 Lupin has announced that its US subsidiary has launched the all new InspiraChamber Anti-Static Valved Holding Chamber (VHC). The company has accomplished this under a strategic licensing agreement with New Jersey-based respiratory research and development company InspiRX. The agreement grants Lupin exclusive rights to promote, distribute and market InspiraChamber VHC in the USA. Developed by InspiRX, the all new InspiraChamber VHC is a device that has been designed to enhance delivery of aerosol therapies. The InspiraChamber VHC is intended to be used by patients who are under the care or treatment of a physician or licensed healthcare professional. The device is intended to be used by these patients to administer aerosolized medication from most pressurized Metered Dose Inhalers (pMDIs). The InspiraChamber VHC launch strengthens Lupin existing brand portfolio in the United States. Lupin's current brands sales force will promote InspiraChamber in the US market and the product will be marketed along with other Lupin brands, including Suprax, Alinia for Oral suspension, Locoid Lotion and Antara. "We are very excited with the addition of InspiraChamber VHC to our brand business portfolio. The launch demonstrates Lupin's commitment to grow its brand franchise in the US and bring meaningful products to patients in the country. The launch also heralds Lupin's entry into the larger US inhalation and related markets," said Ms Vinita Gupta, CEO, Lupin. Mr Michael Amato, CEO of InspiRx said, "The agreement enables the commercialization of InspiraChamber in the US. Furthermore, and given Lupin's brand equity within the US Pediatric community, the launch ensures that the product reaches children, infants and toddlers, an age demographic which we feel needs a product like InspiraChamber; a VHC that ensures better and more effective drug delivery." ]]> <![CDATA[Cipla invests in a respiratory device firm]]> https://biospectrumindia.com/news/95/3294/cipla-invests-in-a-respiratory-device-firm.html https://biospectrumindia.com/news/95/3294/cipla-invests-in-a-respiratory-device-firm.html Thu, 19 Feb 2015 13:13:57 +0530 Cipla has announced that it will acquire 60 percent stake in Jay Precision Pharmaceuticals for Rs 96 crore, says reports. Jay Precision is an existing supplier of respiratory devices to the company and has a manufacturing facility at Vasai, Maharashtra. "Considering company's leading position in inhalation therapy, this transaction is aimed at integrating the value chain and will serve as a platform for the development of next generation respiratory devices," the company said in a statement. The transaction is expected to be completed by the end of this financial year, subject to completion of certain conditions. ]]> <![CDATA[Sanofi, Lead Pharma to develop treatments for autoimmune diseases]]> https://biospectrumindia.com/news/95/1999/sanofi-lead-pharma-to-develop-treatments-for-autoimmune-diseases.html https://biospectrumindia.com/news/95/1999/sanofi-lead-pharma-to-develop-treatments-for-autoimmune-diseases.html Thu, 19 Feb 2015 12:33:46 +0530 Sanofi announced that it has entered into a research collaboration and license agreement with Dutch biotech Lead Pharma to discover, develop and commercialize small-molecule therapies directed against the nuclear hormone receptors called ROR gamma t, to treat a broad range of autoimmune disorders, including rheumatoid arthritis, psoriasis and inflammatory bowel disease, which are among the most common. Under the terms of the agreement, Sanofi and Lead Pharma will collaborate during the early phase of research and development with a goal of identifying drug candidates and beginning human trials within 3-4 years. Lead Pharma will receive an upfront payment and is eligible to receive research, development, regulatory and commercial milestone payments. Sanofi will be responsible for clinical development and have worldwide marketing and commercialization rights to any products that may be developed as a result of the collaboration. Lead Pharma is entitled to receive royalty payments on global sales from any such products. Further details of the financial terms have not been disclosed. "Anti-ROR gamma t therapies represent a ground-breaking opportunity that we are eager and motivated to pursue through our collaboration with Lead Pharma," said Mr Christian Antoni, vice president and head of the immunology & inflammation franchise, R&D, Sanofi. "At Sanofi, we believe networked innovations - working collaboratively across science sectors - is the most effective way to bring meaningful new therapies to patients. To this end, Lead Pharma's innovative capabilities and productivity, exemplified by the ROR gamma t program, make them ideal partners for Sanofi in this area of drug discovery." ]]> <![CDATA[India, Sri Lanka to cooperate on health issues ]]> https://biospectrumindia.com/news/95/4360/india-sri-lanka-to-cooperate-on-health-issues-.html https://biospectrumindia.com/news/95/4360/india-sri-lanka-to-cooperate-on-health-issues-.html Wed, 18 Feb 2015 15:00:24 +0530 The union health and family welfare minister, Mr J P Nadda on February 16, 2015 met Mr Rajitha Senaratne, minister of health and indigenous medicine, Government of Sri Lanka and discussed issues related to increasing cooperation between the two countries in health sector. Indian health minister shared with his Sri Lankan counterpart that India has taken a series of steps to prevent and contain the threat from Ebola virus and underlined the need for cooperation between the two countries to guard against infectious disease threats. He also underscored the need for expanding bilateral cooperation in the area of health, including traditional medicines, through formal MoUs on health cooperation and hoped that these could be finalised and signed at the earliest. Mr Nadda noted that the relations between India and Sri Lanka are unique and based upon shared historical, cultural, ethnic and civilizational ties and extensive people-to-people interaction. He extended an invitation to Mr Rajitha Senaratne to attend the next SAARC Health Ministers' Meeting at New Delhi which India has offered to host in the near future. Both sides agreed to expand bilateral cooperation in health and to resolve the issues, if any, amicably through mutual consultations since India and Sri Lanka have close and friendly relations. ]]> <![CDATA[With huge GSK funding, IAVI expands vaccine research ]]> https://biospectrumindia.com/news/95/4350/with-huge-gsk-funding-iavi-expands-vaccine-research-.html https://biospectrumindia.com/news/95/4350/with-huge-gsk-funding-iavi-expands-vaccine-research-.html Wed, 18 Feb 2015 12:40:17 +0530 The grant of $350,000 from GSK will help the IAVI to support implementation of the Human Vaccines Project, a new public-private partnership seeking to transform global disease prevention by collaboratively addressing some of the principal scientific problems impeding vaccine development across diseases. Dr Wayne C Koff, chief scientific Officer, IAVI and founding member of the Human Vaccines Project Board, announced the GSK grant during a press meet in New Delhi on Febrruary 14, 2015. "Industry involvement will be key to the success of the Human Vaccines Project, and we are excited that GSK has become the first corporate partner of the Project. Their support will help to engage other pharmaceutical partners to join this important new initiative," said Dr Koff. The GSK grant will help to establish the Project's global consortium and plan its research program. The funding builds on a grant last year to IAVI by the Robert Wood Johnson Foundation for a series of workshops to explore how to accelerate development of vaccines via a Human Vaccines Project, by tackling the major scientific challenges impeding vaccine research and development (R&D) through greater collaboration, increased knowledge sharing, and innovation. The first workshop, held in February 2014, focused on the scientific challenges to vaccine development, at which leading vaccine experts endorsed the Project's objectives and helped to frame its scientific plan. "For all that we have achieved with vaccines, there are still far too many diseases that we can't prevent and which have a devastating impact, particularly in the developing world," said Mr Emmanuel Hanon, senior vice president, Vaccines Research and Development, GSK. "The more we can do - both individually and collectively - to overcome the current scientific challenges the better. We are very pleased to support the Human Vaccines Project and we encourage others to join us in this potentially ground-breaking initiative." The Project's objectives are to facilitate development of new and improved vaccines by deciphering the "Human Immunome," all the genes and proteins associated with the human immune system, and elucidating the "Rules of Immunogenicity", ie, how humans generate effective immune responses with vaccines. Thus, the Project aims to address the common scientific obstacles preventing development of vaccines against major and emerging infectious diseases and cancers complementing ongoing disease- specific vaccine development efforts. In July 2014, 20 business leaders from the public and private sectors reviewed the Project's mission and goals, and recommended the Project be structured as a global, nonprofit R&D consortium closely engaged with industrial partners, and affiliated with one or more academic centers conducting vaccine R&D (Expert Review of Vaccines, in press). The Project is currently in the process of establishing the principal hubs of such a consortium, including exploration of centers in the United States, Europe and Asia, to which leadership of the Project will then transition from IAVI, its initial catalyst. "The Human Vaccines Project is driven by the rapid pace of technological advances in genomics, bioinformatics and structural and systems biology, and likely would not have been possible even five years ago. It is a tremendously exciting time in vaccinology as we move toward preventing very challenging global killers such as AIDS, TB, malaria, Ebola, and cancers. Science and innovation will get us the vaccines we need," said Mr Stanley Plotkin, Emeritus Professor of the University of Pennsylvania and Chairman of the Human Vaccines Project Steering Committee. ]]> <![CDATA[FDA approves Lucentis for diabetic retinopathy ]]> https://biospectrumindia.com/news/95/5470/fda-approves-lucentis-for-diabetic-retinopathy-.html https://biospectrumindia.com/news/95/5470/fda-approves-lucentis-for-diabetic-retinopathy-.html Wed, 18 Feb 2015 12:18:37 +0530 Lucentis is administered by a physician as an injection into the eye once a month. It is intended to be used along with appropriate interventions to control blood sugar, blood pressure and cholesterol. Diabetic retinopathy is the most common diabetic eye disease and is a leading cause of blindness in adults in the United States. "Diabetes is a serious public health crisis, affecting more patients every year," said Mr Edward Cox, director of the Office of Antimicrobial Products in the FDA's Center for Drug Evaluation and Research. "Today's approval gives patients with diabetic retinopathy and diabetic macular edema the first significant therapy to treat this vision-impairing complication." According to the Centers for Disease Control and Prevention (CDC), diabetes (type 1 and type 2) affects more than 29 million people in the United States and is the leading cause of new blindness among people ages 20 to 74 years. In 2008, 33 percent of adults with diabetes aged 40 years or older had some form of DR. In some cases of DR with DME, abnormal new blood vessels grow on the surface of the retina. Severe vision loss or blindness can occur if the new blood vessels break. ]]> <![CDATA[â€œNavitas is poised to play a pivotal role in interpreting market and regulatory changeâ€?]]> https://biospectrumindia.com/interviews/95/5665/navitas-is-poised-to-play-a-pivotal-role-in-interpreting-market-and-regulatory-change.html https://biospectrumindia.com/interviews/95/5665/navitas-is-poised-to-play-a-pivotal-role-in-interpreting-market-and-regulatory-change.html Tue, 17 Feb 2015 17:16:00 +0530 To begin with, could you please give an overview ofNavitas and its business vision for our Asia Pac readers?Navitas, a wholly owned subsidiary of TAKE Solutions, is a pure-play 360-degree Life sciences solutions provider. The Navitas team has been assembled by bringing together the proven expert teams of TAKE Life Sciences and WCI and, adding to this core, a range of experts from the worlds of Clinical Development, Regulatory, Technology, and Consulting. The Navitas team has been built specifically to deliver insight to clients, develop pragmatic solutions, and to support their deployment and operation. Navitas delivers advice, solutions and services in Clinical, Regulatory, Safety and Content Management. The legacy businesses have served the sector for some 15 years. Navitas is poised to play a pivotal role as 'Expert Navigators' in interpreting market and regulatory change; driving collaboration across companies; seeking the simple solution to the complex problem; investing to enable the changes. Our vision at Navitas is to be the best knowledge company in the life sciences R&D space by delivering the products, knowledge process outsourcing services and domain consulting expertise that the position entails. Navitas comprehensively covers consulting, technology and outsourcing (functional services) across the clinical, regulatory, safety and quality/compliance functions for the life sciences industry. TAKE Solutions has been serving the life science sector for 15 years! Is there a specific reason why 2015 was chosen to launch the spin-off, Navitas?We serve the pharma and biotech R&D, an underserved domain and a deep knowledge business. Over the last several years we have built a very strong portfolio of serving more than 100 customers globally. So, we want to give this business a very unique identity. As our go-to-market strategy, we have given it a distinct brand identity with the name Navitas. Navitas will stand as a differentiated entity offering a high degree of specialization to meet the requirements of life science industry clients of varying sizes and complexity. We have already launched Navitas and it has been accepted very well in the market. Will there be an addition to the portfolio of products or services offered by Navitas?We have always believed in deep subject matter expertise in Life Sciences and all our investments to date reflect our vision of being a comprehensive and a global collaborative partner to the bio-pharmaceutical and medical device industry. The growth in the industry has only highlighted the challenges of sustainable revenue growth with better margins against the backdrop of an increasingly stringent global regulatory regime. Navitas provides a very unique top down CxO advisory supported by collaborative industry networks. We guide our customers through change management, governance, process overhaul and organization redesign and keep the industry well informed and hand-hold them through transformations. Navitas has adequately complemented this capability with organic technology offerings coupled with strategic partnerships with enterprise software companies. We have a service enablement capability which is very operational oriented and provides high quality and cost effective, value-added outsourced services, as evidenced by our 'industry first' accomplishments of unit pricing per deliverable and other significant efficiency metrics. We are quite clear that this unique approach to solving problems is essential and we will be attempting to grow them all and contribute equally to our revenues. Is there an untapped market (i.e. any other country) that Navitas plans to foray in the coming years? Currently, the major markets driving growth are US and Europe. We have plans in place to expand into Japan by FY 2017. If you were to compare India with other countries, what would be your observation about Indian drug manufacturers and medical device manufacturers meeting global regulatory and compliance requirements? If there is a gap, how can Navitas play a part to resolve the issue? Companies in the US and Europe, which are higher up the maturity curve than their Indian counterparts, are looking for cost advantages along with better quality outsourced services. These services are focused on areas like patent management, clinical trial & quality control. The branded/NCE research that these companies undertake necessitates innovation and adoption of cutting edge technologies to stay ahead of the curve. These companies are hence investing heavily in new technologies and concepts that are essential for discovery and R&D efforts, while looking to outsource staple services to vendors with reputation and economies of scale. With this new spin-off are there any M&A plans?It is too premature to think of that. We have quite a bit to grow in size in the Life sciences business. It is a great opportunity as it is a space that is growing fast and we want to give it our complete focus. What is your human capital requirement plan for the next two years? Our human capital growth will be determined by our business needs. Ours is not a linear business model. So additions will be more a step function. We may become twice our current size - say add another 1000 people. What would be the business revenue generated by Navitas after three years?We expect it to be about approximately $100 mn and more in three years. ]]> <![CDATA[GSK strengthens vaccine pipeline by acquiring GlycoVaxyn]]> https://biospectrumindia.com/news/95/6099/gsk-strengthens-vaccine-pipeline-by-acquiring-glycovaxyn.html https://biospectrumindia.com/news/95/6099/gsk-strengthens-vaccine-pipeline-by-acquiring-glycovaxyn.html Tue, 17 Feb 2015 13:29:25 +0530 The company is focused on the development of next-generation bioconjugate vaccines against bacterial infections, utilizing its versatile and innovative bioconjugation platform. Since forming a scientific collaboration in 2012, GSK has held a minority stake in GlycoVaxyn and has now acquired the remaining shares for US $190 million (approximately £124 million) in cash to take full ownership of the company. GlycoVaxyn has developed an innovative biological conjugation platform technology which has the potential to play an important role in the development of new prophylactic and therapeutic vaccines for a range of bacterial diseases. This proprietary technology also has the potential to enable GSK to develop a simplified conjugate vaccine manufacturing process. Under the terms of the transaction, GSK will additionally acquire a small number of early stage vaccines in development against bacterial infections such as pneumonia, pseudomonas, staphylococcus aureus and shigellosis, supplementing the company's existing vaccines pipeline. Dr Moncef Slaoui, chairman of vaccines, GSK said: "This is an exciting opportunity to expand our research efforts to develop a new generation of vaccines for common and severe bacterial infections, for many of which there are currently no effective vaccines. It reinforces our commitment to seek out and invest in great science and complements our proposed transaction with Novartis which will strengthen our leading position in vaccines." With today's transaction, GSK has now purchased all shares in GlycoVaxyn, valuing the company at US $212 million (approximately £139 million). GlycoVaxyn was supported by investments from life science venture capital firms including Sofinnova Partners, Index Ventures and Edmond de Rothschild Investment Partners. GlycoVaxyn also received funding from the Wellcome Trust and through a collaboration with Janssen Pharmaceuticals. ]]> <![CDATA[USFDA approve Eisai's anticancer agent]]> https://biospectrumindia.com/news/95/6071/usfda-approve-eisais-anticancer-agent.html https://biospectrumindia.com/news/95/6071/usfda-approve-eisais-anticancer-agent.html Tue, 17 Feb 2015 13:28:29 +0530 It is said to serve as a treatment for locally recurrent or metastatic, progressive, radioactive iodine-refractory differentiated thyroid cancer (RAI-R DTC). Lenvima was granted priority review status by the FDA, and was ultimately approved six months from the submission of the New Drug Application in August 2014, two months ahead of the FDA priority review action date. This marks the first country in the world where the agent has received marketing authorization. Lenvima is an orally administered molecular targeted agent that selectively inhibits the activities of several different molecules including VEGFR, FGFR, RET, KIT and PDGFR. In particular, the agent simultaneously inhibits VEGFR, FGFR and also RET which are especially involved in tumor angiogenesis and proliferation of thyroid cancer. Furthermore, Lenvima has been confirmed through X-ray crystal structural analysis to be the first compound to demonstrate a new binding mode (Type V) to VEGFR2, and exhibits rapid and potent inhibition of kinase activity, according to kinetic analysis. ]]> <![CDATA[Book on GM Crops: Perception versus Reality released in India]]> https://biospectrumindia.com/news/95/5559/book-on-gm-crops-perception-versus-reality-released-in-india.html https://biospectrumindia.com/news/95/5559/book-on-gm-crops-perception-versus-reality-released-in-india.html Tue, 17 Feb 2015 12:02:00 +0530 GM crops has proved to be one of the most contentious public issues in Indian society. Some of the perceptions includes: risk to human health, environmental impact, increase in economic power of multinational corporations and so on. These attitudes are shifting, but are still strongly hostile to GM technology. In order to provide correct information on GM crops and technology and to bust the myth surrounding it, the Forum of Former Vice Chancellors of Karnataka State Universities (FVCK) and the Association of Biotechnology Led Enterprises Agricultural Group (ABLE-AG) released a new book titled GM Crops: Perception vs Reality written by Dr. T. M. Manjunath and Dr. K. S. Mohan. The authors have more than 40 years of research experience in plant protection and biotechnology. The book was released recently in Bangalore India Bio 2015. The book discusses commercial cultivation of GM crops and stresses their importance in effective pest control and better weed management in selected crops, resulting in increased crop production and significant reduction in the use of pesticides. The book addresses common public perceptions around biotechnology by presenting scientific facts and data from authentic and credible sources. Agri-biotech, by increasing income of small and resource-poor farmers, contributes directly to the poverty alleviation of a large majority of the world's poorest people. Until now biotech cotton in India has already made a significant contribution to the income of poor farmers. It is high time now to apply such technologies for production of food crops. The book discusses how Agri-biotechnology is safe, scientifically based, farmer friendly and is a most important tool to ensure food security under most circumstances. Every country which has permitted or in the process of permitting commercialization of GM crops, has formed stringent biosafety protocols and made it mandatory for every GM crop to pass through all the prescribed tests. The results obtained from such trials are scrutinized by a series of expert committees and it is only on being satisfied with the scientific data that they are safe to humans, animals and the environment, permissions are accorded for their commercialization. Every GM crop approved so far in every country has gone through this process. For example, in India, Bt-cotton is the only GM crop approved since 2002. Prior to its approval, it has undergone about 500 agronomic trials and a large number of biosafety tests for 7-8 years. These trials were supervised by about 150 scientists belonging to 13 agricultural universities and 9 national research institutes spread across 9 states! The safety data pertaining to these studies were submitted to the regulatory authorities. On the strength of such scientific data, Bt-cotton was considered as safe and approved for commercial cultivation by the Genetic Engineering Appraisal Committee (GEAC) of Government of India in March 2002. Several other crops, including Bt-brinjal, incorporated with various beneficial traits, have been under regulatory trials for 5-8 years, but they are yet to receive regulatory approvals. Such inordinate delays have frustrated the biotech scientists, students and companies and affected the progress of biotechnology. Being so, the opponents of this technology have been vociferously alleging that the GM crops are dangerous, not subjected to adequate tests, approvals are given in a haste, etc.! This is not true.. Ever since their approval in 1996 in the USA and other countries, the GM crops have recorded an unprecedented adoption - 1.7 million hectares in six countries in 1996 to over 175 m ha in 27 (19 developing, 8 industrial) countries by 18 m farmers in 2013, which is about a 100-fold increase in area in 18 years! The USA, Argentina, Brazil, India, Canada, China, Paraguay, South Africa and Pakistan are the major countries cultivating GM crops. The technology has been introduced mainly in soybean, corn, cotton, canola and papaya. Owing to effective control of target pests and good weed management in these crops, the yields have significantly increased. Use of chemical pesticides has declined, leading to economic and social benefits to millions of farmers across the world in addition to environmental benefits due to reduction in pesticide use. Similar benefits have accrued to the Indian cotton farmers with the introduction of Bt-cotton in 2002. The area under Bt-cotton as of 2013 was about 11 million hectares that comprised 95% of the total cotton acreage in our country, being adopted by over 7 million (70 lakh) farmers. Book says that as a result of effective control of bollworms due to Bt-cotton, coupled with other factors, the yield of cotton has doubled, contributing to economic and social prosperity of the farmers. Besides, it turned India from an importer of cotton to an exporter. ]]> <![CDATA[NCBS signs MoU with CNRS, UniversitÃ© d'Aix Marseille]]> https://biospectrumindia.com/news/95/5536/ncbs-signs-mou-with-cnrs-universit-daix-marseille.html https://biospectrumindia.com/news/95/5536/ncbs-signs-mou-with-cnrs-universit-daix-marseille.html Mon, 16 Feb 2015 11:57:51 +0530 An agreement for the creation of an international associated laboratory between National Center for Biological Science (NCBS), the French National Center for Scientific Research (CNRS) and the University of Aix Marseille was signed at NCBS, Bangalore. The agreement was signed by Dr Catherine Jessus, director of the National Institute of Biological Sciences of CNRS, and Dr Satyajit Mayor, director of NCBS. In addition, the Consul General of France, Mr Eric Lavertu, was present for the signature of the agreement for the creation of an international associated laboratory. An international associated laboratory is a 'laboratory without wal'. It brings together a French laboratory, the Institut de Biologie du DÃ©veloppement de Marseille, and an Indian laboratory, the laboratory of Satyajit Mayor at NCBS, pooling together human and material resources in order to implement a jointly-defined research program. This international associated laboratory represents an opportunity for students and researchers to work in a scientific environment of international excellence and inter-disciplinarity. The international associated laboratory is coordinated by two coordinators, one French and one Indian, who jointly assume scientific responsibility. The coordinators are: Dr Thomas Lecuit, Institut de Biologie du DÃ©veloppement, CNRS / University of Aix Marseille - Dr Satyajit Mayor, National Center of Biological Sciences, Bangalore. This new international associated laboratory aims at understanding the biochemical and physical basis of epithelial tissue organization and dynamics. The complementary expertise of the French and Indian partners will allow quantitative study of these dynamic processes at different scales (molecular, supramolecular, cellular and tissue). The international associated laboratory is called as 'Systems Biology of Tissue Mechanics' (SysTiM). ]]> <![CDATA[Mahyco, Arcadia Biosciences develop water efficient rice ]]> https://biospectrumindia.com/news/95/6986/mahyco-arcadia-biosciences-develop-water-efficient-rice-.html https://biospectrumindia.com/news/95/6986/mahyco-arcadia-biosciences-develop-water-efficient-rice-.html Mon, 16 Feb 2015 09:57:00 +0530 Maharashtra Hybrid Seeds (Mahyco), a major seed company in Southeast Asia and Arcadia Biosciences, an agricultural technology company focused on developing technologies and products that benefit the environment and human health, on Feb 13, 2015 announced the achievement of a key milestone in the development of Water Use Efficient (WUE) rice. Arcadia received a significant but undisclosed payment for this milestone from Mahyco. Arcadia's WUE technology seeks to improve crop yields under episodic water-stress conditions typical to global agriculture, as well as under severe drought conditions. WUE rice developed by Mahyco is expected to be among early examples of crops bred to withstand the varying environmental effects of climate change while expanding the range of usable acreage for crop production. Mahyco demonstrated that Arcadia's WUE technology significantly increased plant growth under normal and water-stress conditions in multiple rice lines developed by Mahyco. The rice lines incorporating Arcadia's WUE technology showed double-digit increase in key plant performance and yield measures.Commenting on this development, Dr Usha Zehr, chief technology officer at Mahyco said, "With this milestone, we are closer to bringing the benefits of this technology to the farmers who are challenged with reduced water availability on their farms and improving the overall productivity of the crop." "At a time when farmers in India face significant pressure to increase productivity, factors such as urban growth, drought and rainfall variations are limiting water resources available for agriculture, particularly for water intensive crops such as rice," said Mr Eric Rey, president and CEO of Arcadia. "Through our collaboration with Mahyco on WUE and other agronomic technologies, we're working to increase yields and improve efficiency in the use of key inputs, such as fresh water." added Mr Rey. Rice is the world's most valuable crop, grown on 162 million hectares globally with a harvest value of $334.7 billion in 2012 (FAO 2012 statistics; FAOSTAT). This crop plays a critical role in food security for more than half of the world's population. Based on current growth rates, India is expected to overtake China as the world's most populous nation by the year 2030. The United Nations Food and Agriculture Organization (FAO) estimates that 221 million people in India, or about one-fifth of the population, are undernourished. ]]> <![CDATA[Agriculture minister bats for GM crops]]> https://biospectrumindia.com/news/95/5196/agriculture-minister-bats-for-gm-crops.html https://biospectrumindia.com/news/95/5196/agriculture-minister-bats-for-gm-crops.html Mon, 16 Feb 2015 09:56:11 +0530 "Apart from increased productivity to produce more from less input including water and land, the losses that occur due to droughts, floods, salinity, biotic and other abiotic stresses also need to be eliminated decisively through the adoption of appropriate technologies. In this context, genetic engineering holds great promise." This was stated by the union agriculture minister, Mr Radha Mohan Singh while speaking on the occasion of inauguration of India Seed Congress-2015 at Agra on February 13, 2015. Mr Singh emphasized that increase in farmers' income and quality food supply to consumers at affordable prices are closely linked to supply of quality seeds with all the required traits for substantial increase in productivity."Bt cotton in Gujarat and other states like Maharashtra, Andhra Pradesh, Karnataka and Tamil Nadu has clearly demonstrated what these new technologies can do to enhance farmer incomes with consequential effects on their well-being. Besides, newer technologies like herbicide tolerance, drought tolerance, nitrogen use efficiency, healthy oils and feed, and nutrition enhancement, can, when introduced commercially in India, substantially increase productivity leading to greater farmer incomes and farmer well-being," he said. The minister mentioned that international institutional collaborations both in public and private sector are essential to introduce innovations and technologies to the farmers. However such arrangements should benefit all the stakeholders and faster technology diffusion and adoption can happen only if there is a rational regime for technology pricing and licensing which enables a level playing field and also fosters healthy competition, he said. Mr Singh emphasised that the superior genetics encapsulated in seed combined with improved agronomies shall be the key strategy to break the yield barriers. He said that in this direction the private organized seed industry has significantly contributed and successfully complemented with the public sector. Government shall therefore support PPP initiatives for overall development of the sector, he said. Mr Singh said that a substantial increase in productivity is the answer to achieve food security in an efficient and sustainable manner,he said. Mr Singh further added that while agriculture feeds the nation, seeds feed agriculture. Seeds are a critical determinant of productivity in agriculture. By embedding various types of values, like health enhancing benefits, crop protection and water and soil nutrients to resist adverse climatic conditions, a seed is eminently suited to increase productivity. Thus, appropriate policy support for seed improvements through conventional and biotech methods, in combination with improved agronomic practices, would greatly help in ensuring food and nutritional security of the country, he said. ]]> <![CDATA[J&J launches 3 new platforms focused on diseases]]> https://biospectrumindia.com/news/95/6033/jj-launches-3-new-platforms-focused-on-diseases.html https://biospectrumindia.com/news/95/6033/jj-launches-3-new-platforms-focused-on-diseases.html Sun, 15 Feb 2015 10:16:00 +0530 Unveiling three new platforms, J&J has revealed that its focus now would be on redefinig healthcare by preventing and intrecepting diseases. It will also try to understand the role of the microbiome. Of the 3 units, the first of which is the Janssen Prevention Center, headquartered in the Netherlands, which will focus on preventing diseases uch as Alzheimer's, heart, cancer and autoimmune diseases. The Disease Interception Accelerator will explore the origins of diseases, including type 1 diabetes, such as genetic predisposition, environmental exposure and phenotypic alterations, and try to pre-empt them. The Janssen Human Microbiome Institute, the third of the series launched, will study the microbiome, the diverse bacteria living in and on the body. The role of these bacteria are under increasing scrutiny for the role they play in human health. These teams will collaborate with the existing Janssen R&D unit. ]]> <![CDATA[Drug regulators invited by US FDA to join inspections]]> https://biospectrumindia.com/news/95/6032/drug-regulators-invited-by-us-fda-to-join-inspections.html https://biospectrumindia.com/news/95/6032/drug-regulators-invited-by-us-fda-to-join-inspections.html Sun, 15 Feb 2015 09:55:00 +0530 The central and state drug regulatory officials have been invited by the US FDA to accompany their teams inspecting pharma units in the country. This was stated by Mr Soloman Yimam, assistant country director, the US FDA India Office, while addressing sessions during the recently concluded BioAsia. The move comes after an MoU was signed between the two countries in Feb last year. "Based on that MoU whenever we do GMP (Good Manufacturing Practice) inspections we invite DCGI (Drug Controller General of India) officials and State regulators to accompany us on the inspections," said Mr Yimam to a leading newspaper. Asked whether the process is being practiced, he said that there were glitches but it was what they are striving towards. ]]> <![CDATA[Plant extract may treat brain tumour]]> https://biospectrumindia.com/news/95/5708/plant-extract-may-treat-brain-tumour.html https://biospectrumindia.com/news/95/5708/plant-extract-may-treat-brain-tumour.html Sat, 14 Feb 2015 10:03:00 +0530 Scientists at the Max Planck Institute of Psychiatry in collaboration with Helmholtz Zentrum MÃ¼nchen have discovered that Silibinin can be applied to treat Cushing Disease in cell cultures, animal models, and human tumor tissue. Cushing Disease is a rare hormone condition caused by a tumor in the pituitary gland in the brain. The tumor secrets increased amounts of the stress hormone Adrenocorticotropin (ACTH). After silibinin treatment, tumor cells resumed normal ACTH production, tumor growth slowed down and symptoms of Cushing Disease disappeared in mice, according to the scientists. Silibinin, a constituent of milk thistle seeds has an outstanding safety profile in humans and is currently used for the treatment of liver disease and poisoning. The researchers have filed a patent and now plan clinical trials using silibinin as a non-invasive treatment strategy. Thus, in future, patients might not have to undergo brain surgery anymore. The study was published in the journal Nature Medicine. ]]> <![CDATA['We need continued investment in R&D']]> https://biospectrumindia.com/interviews/95/4541/we-need-continued-investment-in-rd.html https://biospectrumindia.com/interviews/95/4541/we-need-continued-investment-in-rd.html Fri, 13 Feb 2015 13:15:16 +0530 What the government should do to promote GM technology?First of all, scientific community has to produce good and convincing data about the GM crops, that it is not harmful to humans, animals and environment and is beneficial. Once it is there, based on that, government can provide a legislation for the promotion of GM technology. I do believe that the data is available perhaps not in India but elsewhere, this has to be additionally conducted each year on any GM crop, whether it is harmful to beneficial insects and environment and that would be the basis for the government to provide legislative support, so that it can go ahead. What are the three steps that government must take to support agri-biotech in the country?First, have well-supported research and development (R&D) at the ground level. Second would be to encourage Indian private companies and the public institutions to work together, biotech projects has to be together and third would be to provide positive and effective legislation so that it goes to the farmers. You mentioned earlier, that the global food demand to increase three-fold by 2050. What role India can play to increase food productivity in the world?We need continued investment in the R&D and broad emergence of private companies in all parts of the country, so that they are participating in the development of technology and taking it to the famers. We also need good training of farmers and some degree of subsidy for the advanced technology and we need marketing structures. Of the 200 wheat varieties which you have cultivated, which one is the most popular and largest growing?There are actually 400 varieties of wheat. Few of them have been very popular, they had been grown all the way from India to Morocco, but the magic is that one variety is not cultivated at all the places because if the disease breaks down at one place, it breaks like fire. So, what we provided was multitudes of variety for the diversity of wheat agriculture which was not there before and I think that was my biggest contribution in this area. With the new varietal base and the technology we provided 200 million additional metric tons worldwide, large part of that in India, in the northern wheat belt. Any last comment.I would to like to see 10-15 percent increase in Indian crop production in the next ten years and also that good prizes are given to farmers. ]]> <![CDATA[Glenmark's consolidated revenue up by 6.22% in Q3]]> https://biospectrumindia.com/news/95/4627/glenmarks-consolidated-revenue-up-by-6-22-in-q3.html https://biospectrumindia.com/news/95/4627/glenmarks-consolidated-revenue-up-by-6-22-in-q3.html Fri, 13 Feb 2015 13:12:00 +0530 For the third quarter ended December 31, 2014, Glenmark's consolidated revenue was at Rs 17,013.07 Mn ($274.80 Mn) as against Rs 16,017.52 Mn ($259.64 Mn) an increase of 6.22 percent. The consolidated Net Profit was at Rs 1,147.60 Mn for the quarter ended Dec 31, 2014 as compared to Rs 2,143.31 Mn for the previous corresponding quarter. The profits for the quarter are not comparable because of foreign exchange losses in Emerging Markets especially Russia, said company in its statement. Business Highlights: â€¢ India Business grew by 13.60 percent to Rs 4,330.73 Mn â€¢ Europe Formulations Business grew by 27.33 percent to Rs 1729.54 Mn â€¢ Latin America Business grew by 105.77 percent to Rs 2,344.40 Mn "Our India, LatAm and Europe businesses performed well in the quarter. While we continue to outperform the Indian pharmaceutical market recording double digit growth, our LatAm business performed exceedingly well with our Mexico and Venezuela subsidiaries growing by over 200% backed by good demand. The slowdown in product approvals and channel consolidation impacted our sales in the US, whereas the devaluation of currency and subdued business environment affected our Russia/CIS business," said Mr Glenn Saldanha, CMD, Glenmark Pharmaceuticals. For the nine month ended Dec 31, 2014, Glenmark's consolidated revenue was at Rs 48,689.55 Mn as against Rs 43,033.75 Mn, an increase of 13.14 percent over the previous corresponding period. "We have been making steady progress in our innovation pipeline and now have three first-in-class monoclonal antibodies (mAb) in clinical development; making us among the few companies in the world to have such a robust pipeline of mAbs," Mr Saldanha further added. India Formulations Sales for the formulation business in India for the third quarter ended December 31, 2014, was at Rs 4330.73 Mn ($69.82 Mn) as against Rs 3,812.30 Mn ($61.52 Mn) in the previous corresponding quarter, recording a growth of 13.60 percent. USA Formulations Glenmark Generics, USA registered revenue from sale of finished dosage formulations was at Rs 5072.01 Mn ($81.82 Mn) for the quarter ended December 31, 2014 against revenue of Rs 5213.60 Mn ($84.17 Mn) for the previous corresponding quarter, recording a decrease of 2.72 percent. Africa, Asia and CIS Region (ROW) For the third quarter, revenue from Africa, Asia and CIS region was Rs 2071.49 Mn ($33.48 Mn) as against Rs 3,014.89 Mn ($49.29 Mn) for the previous corresponding quarter, recording a decrease of 31.29 percent. Europe Formulations Glenmark Europe's operations revenue for the third quarter ended December 31, 2014 was at Rs 1729.54 Mn ($28.08 Mn) as against Rs 1358.35 Mn ($22.16 Mn) recording growth of 27.33 percent. Latin America Glenmark's revenue from its Latin American and Caribbean operations was at Rs 2344.40 Mn ($38.00 Mn) for the third quarter ended December 31, 2014 as against Rs 1139.31 Mn ($18.49 Mn), recording an increase of 105.77 percent. Active Pharmaceutical Ingredients (API) Revenue from sale of API to regulated and semi-regulated markets globally was Rs 1464.91 Mn ($23.60 Mn), for the quarter ended December 31, 2014 against Rs 1479.07 Mn ($24.02 Mn) for the previous corresponding quarter. ]]> <![CDATA[DCGI approves Biogen's MS drug]]> https://biospectrumindia.com/news/95/5867/dcgi-approves-biogens-ms-drug.html https://biospectrumindia.com/news/95/5867/dcgi-approves-biogens-ms-drug.html Fri, 13 Feb 2015 13:01:36 +0530 Biogen has received approval for the first oral therapy drug Tecfidera for multiple sclerosis by the Drug Controller General of India ( DCGI). According to the company, The new medication will be available in the Indian market from second week of February 2015. Tecfidera is the first oral drug for the treatment of relapsing-remitting multiple sclerosis (RRMS) in India, it added. "We believe Tecfidera provides a new option for patients in India, particularly as it provides the convenience of oral dosing," said Ms Pooja Vatsyayan, Biogen India's acting managing director, in a statement. The approval of drug is based on the data from a robust clinical development program of two global phase III studies that enrolled more than 2,600 patients. ]]> <![CDATA[Cipla wins $188.95 Mn of Global Fund ARV Tender]]> https://biospectrumindia.com/news/95/4622/cipla-wins-188-95-mn-of-global-fund-arv-tender.html https://biospectrumindia.com/news/95/4622/cipla-wins-188-95-mn-of-global-fund-arv-tender.html Fri, 13 Feb 2015 11:56:18 +0530 The company has been selected as a 'Panel Supplier' for a Supplier Partnership Agreement. The contract is effective from the 1st of January 2015 and will run for a period of three years. The supplies will begin from Q4 FY 2015. Mr Subhanu Saxena, MD and global CEO, Cipla, said: "We are extremely proud to have won this tender from Global Fund. Cipla has been committed to the cause of HIV/AIDS for over two decades and this tender offers us a great opportunity to make HIV/AIDS treatment accessible to more than 140 countries through Global Fund." Cipla has a long-term association with Global Fund since 2002. Last year, the company has been one of the suppliers who has been awarded with a long-term contract for supplying anti-malarial drugs. The anti-retrovirals drugs will be manufactured in Cipla's state-of-the-art manufacturing facilities in India, which has been approved by various international regulatory agencies. ]]> <![CDATA[Innovation must for keeping industry thriving! ]]> https://biospectrumindia.com/features/95/5206/innovation-must-for-keeping-industry-thriving-.html https://biospectrumindia.com/features/95/5206/innovation-must-for-keeping-industry-thriving-.html Fri, 13 Feb 2015 10:14:00 +0530 Despite feel good factors and optimism, Indian innovation ranks globally are sliding down. It was visible when in July, 2014, the annual rankings of Global Innovation Indicator ranked us at 76th position, a good 10 places down than what it was in previous year. The results are jointly published by Cornell University, INSEAD, and the World Intellectual Property Organisation. It surveys 143 economies around the world, using 81 indicators to gauge innovation capabilities and results. Except for few genuine cases, India has been known for its 'Jugaad Innovation' which means taking the easiest possible route for establishing a short-term order until the next one is found. Few will argue that with a huge population and lesser resources, this is the best we can do. But that doesn't stop one from asking why is the real innovation reaching us? Well the reason necessarily is not that there is lack of ideas but possibly of enough translation. The Thompson Reuters 'State of Innovation in India- 2013' states that the pharmaceuticals on basis of the patent activity hold close to 23 percent of overall innovative stuff done in India while agriculture with mere 5 percent is the only next in bioscience domain. Besides that the academia scores higher than industry as the government departments such as department of biotechnology (DBT), Council for Scientific and Industrial Research (CSIR), Defence Research and Development Organization (DRDO) find their places in the list while the number of companies is significantly much lesser than expected. Defining Innovation! There can be different ways to introduce new things and improve the existing ones. However, is that so simple? One of the easiest definitions ever heard of the word 'Innovation' is the desire to overcome existing challenges to establish new order. Giving his own version, Mr Sam Piroda, former chairman, National Innovation Council said, "Although the word innovation might be defined in many ways, I think it should bring about change not just in terms of new products but the processes and delivery too. It cannot be limited only to outcome but the entire process that is part of it. In plain words, it is thinking just outside of box." Dr RA Mashelkar, former director general, CSIR and president, Global Research Alliance and National Innovation Foundation defines it. "In a simple language, innovation is creating ideas and then turning them into something that benefits large sections of society. India being a capital-starved country faces challenges apart from sustainable growth. Therefore, given the scarcity of funds in the present context, I would say "less from less" is not the answer but "more from less" is the solution. Unfortunately, we don't have those extra millions to spend on various initiatives of importance. There is need for the work flow changes to adapt to new requirements. One may ask what is common between selling a burger or an eye-care treatment. It is the sharing of expertise that matters and that make the industries grow. Moreover, the essence of education is to mix multidisciplinary aspects to create something new and useful." Obstacles can damage innovative spirit to a great extent. During one of his talks, Dr MK Bhan, former secretary, DBT identified several of them in India. The reluctance to experiment, talent tool not being diverse enough for product innovation (don't require only scientists); poor flow of knowledge (not enough bi-directional flows); fragmentation in government policies as separate departments for biotech and pharma; and more importantly the lack of cross talk. Therefore novel idea surely is a single brain thing but can it thrive without right kind of environment and partnerships. Agreed Dr Neeraj Sharma, head-technology development and transfer (TDT) and policy research, department of science and technology (DST) when he said, "People of this country are the key stakeholders in this innovation. We need to sow the seeds as early as possible. Government is trying to invoke multi-disciplinary research. There are steps being taken to establish National Innovation System in India. It marks a major shift in the policy. How an innovation based economy can be built, is a question can be answered through various ways." But can it be forced? The DBT has been doing its bid to promote the innovation. Its 'Tata Innovation Fellowship' is, a highly competitive scheme instituted to recognize and reward scientists with outstanding track record in biological sciences and a deep commitment to find innovative solutions to major problems in health care, agriculture. Apart from that the other government institutions and agencies are trying to promote it in their way. Programmes like the Stanford India Biodesign are structured to train professionals in identifying indigenous needs, coming with feasible solutions within various constraints and making their invention affordable, sustainable and scalable. Dr Balram Bhargava, executive director of the programme says that "We are trying to change the milieu of innovation in India through this initiative. The structure of the programme has rapidly caught on with a lot of institutes across the country, which are now following the model in order to develop the medical device innovation ecosystem." The government proposes to launch an innovation fund exclusively for Micro, Small and Medium Enterprises (MSMEs) to encourage and promote new knowledge-driven ventures and programs, revealed Mr Kalraj Mishra, minister of micro, small and medium enterprises, while inaugurating the two-day 'Global R&D Summit 2014' at New Delhi recently. However, is it really translating into something is the big question to ponder upon. Most will agree that the right nurturing and facilities surely can help deliver innovation. However, can it be forced? "For some innovations, we need only environment not always infrastructure. We cannot force innovation. 'Patents' should not be looked from the prism of experience or academic credentials." says Mr Shailendra Porwal, co chairman, FICCI'science and innovation committee. Innovation drives knowledge feels Ms Nabanita Radhakrishnan, director, Directorate of Planning and Coordination, DRDO headquarters, as she too agrees that it surely cannot be forced. "Need to promote innovation culture for schools. It means having gem of an idea and translating it into a product. Innovation cannot happen without liberalization. Procedures and hiccups cannot help flourish the innovation," she opines. From Lab to field The best thing for an industry is its capability to produce more innovative products. It can be either through acquiring of technologies developed by a partner in research or may be by companies themselves. What matters is that at the end of the day there is a product that everybody could appreciate as unique and safe. "It is important to gain from what exists already", says Mr Vinayak Marathe, senior vice president, Reliance Industries who feels that there is lot of innovation in existing processes and from innovation in lab, there is need to talk about innovation in field. Calling the Jugad innovation as temporary one, Dr Anil Wali, managing director, Foundation for Innovation and Technology Transfer, IIT Delhi feels that it should be left at a point and time whereas the real innovation is something different. "The real one is long term effective innovation," he says. Talking about the funding in the name of innovation, Prof Anil K Gupta, director, Wadia Institute of Himalayan Geology, believes that if we need to be knowledge based innovative economy, we have to segregate the expenditure into verticals: R&D or manufacturing. "There is lot of confusion on what is for the innovation and what is meant for meeting the expenditure for the team driving it," he says. The scientific community needs to support the Prime Minister's ambitious vision of 'Make in India' says Dr Sarjerao Bhaurao Nimse, general president, Indian Science Congress Association, who adding further, "Earlier, not much importance was given to R&D but now the stress is on developing innovative technologies. There was an immediate need to invest in research to develop knowledge and this knowledge must be converted into patents so that the investment is able to generate revenue." Industry, he said, must support laboratories and fund the R&D programs. Are the policies alone really going to help the real innovation or not, will eventually get reflected in next ten years. Although one can argue and come up with hundreds of definitions suiting the respective needs, it goes without saying that the real innovation impacts the generations through affordable yet effective implications. So it our industry ready for it? ]]> <![CDATA[Natco Pharma files NDA with USFDA]]> https://biospectrumindia.com/news/95/4311/natco-pharma-files-nda-with-usfda.html https://biospectrumindia.com/news/95/4311/natco-pharma-files-nda-with-usfda.html Thu, 12 Feb 2015 16:40:44 +0530 Natco Pharma has filed Abbreviated New Drug Applications (ANDAs) for fingolimod capsules and cabazitaxel injection with the US Food and Drug Administration (US FDA). "Natco and its associated marketing partners for the above products in the US, believe that they are the first company to have filed a substantially complete ANDA which includes a paragraph IV certification for Fingolimod capsules and Cabazitaxel injection, providing 180 days of marketing exclusivity upon its final USFDA approval," the company said in a filing to BSE. Fingolimod is a generic version of Novartis' Gilenya and is used for the treatment of multiple sclerosis. Cabazitaxel, a generic of Sanofi's Jevtana, is indicated for the treatment of hormone-refractory prostate cancer. Once approved, the company expects to get 180 days of marketing exclusivity for these products. ]]> <![CDATA[Sanofi inks pact with Voyager Therapeutics]]> https://biospectrumindia.com/news/95/4408/sanofi-inks-pact-with-voyager-therapeutics.html https://biospectrumindia.com/news/95/4408/sanofi-inks-pact-with-voyager-therapeutics.html Thu, 12 Feb 2015 14:48:28 +0530 Voyager Therapeutics and Genzyme, a Sanofi company has announced a major strategic collaboration to discover, develop and commercialize novel gene therapies for severe CNS disorders. The collaboration will leverage Genzyme's long-standing commitment and scientific leadership in the field of adeno-associated virus (AAV) gene therapy and Voyager's industry-leading AAV product engine to develop breakthrough therapies for patients suffering from severe CNS disorders. The alliance will encompass multiple gene therapy programs, including programs for Parkinson's disease, Friedreich's ataxia and Huntington's disease, as well as other CNS disorders. Each program targets a severe, debilitating disease and has the potential to deliver transformational therapeutic benefit for patients. The collaboration portfolio created will combine programs and intellectual property from both companies. Voyager will drive research and development activities for all programs, working with Genzyme in a highly collaborative way. Genzyme will have the option to license several programs following completion of an initial proof-of-concept human clinical trial. Genzyme will make an upfront commitment of $100 million to Voyager, including $65 million in cash, a $30 million equity investment in Voyager and additional in-kind contributions. Voyager is eligible to receive future potential development and sales milestone payments of up to $745 million, as well as tiered royalties on product sales. "Through our combined efforts, Voyager and Genzyme are at the forefront of converting the promise of gene therapy into innovative therapies for CNS disorders that make a meaningful difference in patients' lives," said Dr Steven Paul,president and CEO of Voyager. He added, "This strategic collaboration provides significant funding to drive the development of our expanded product pipeline, while also allowing Voyager to continue to thrive as an independent company." "We've been working in gene therapy for more than 20 years, and our commitment remains strong because we believe in its promise to transform the lives of patients with debilitating diseases," said Mr David Meeker, president and CEO of Genzyme. He added, "The field of gene therapy has advanced rapidly in the past several years, and the science has never been better. Joining together with a great partner in Voyager allows us to strengthen and accelerate our efforts to address a set of very challenging neurological diseases." ]]> <![CDATA[PerkinElmer elects Dr Sylvie GrÃ©goire to its Board of Directors]]> https://biospectrumindia.com/news/95/3271/perkinelmer-elects-dr-sylvie-grgoire-to-its-board-of-directors.html https://biospectrumindia.com/news/95/3271/perkinelmer-elects-dr-sylvie-grgoire-to-its-board-of-directors.html Thu, 12 Feb 2015 14:47:46 +0530 PerkinElmer has announced that Dr Sylvie GrÃ©goire has been elected to its Board of Directors, effective February 6, 2015. "It is with great enthusiasm that we welcome Dr Sylvie as the newest member of our Board. Her extensive experience gained through global leadership positions within top pharmaceutical and biotechnology companies will prove highly valuable in helping oversee the strategic direction of the company," said Mr Robert Friel, chairman and CEO, PerkinElmer. With nearly 30 years of industry experience, Dr GrÃ©goire most recently served as the President of Human Genetic Therapies for Shire for seven years. ]]> <![CDATA[Govt set to promote generic medicines on mass scale]]> https://biospectrumindia.com/news/95/6996/govt-set-to-promote-generic-medicines-on-mass-scale.html https://biospectrumindia.com/news/95/6996/govt-set-to-promote-generic-medicines-on-mass-scale.html Thu, 12 Feb 2015 14:43:52 +0530 The 'Jan Aushudhi' drugs will be sold in the retail market at a competitive price, allowing consumers to buy a cheaper yet quality product from the government, official sources said. As per reports, the government has identified 504 essential medicines, which include antibiotics, painkillers, vitamins and medicines used in treatment of cardiovascular, respiratory, diabetes and gastroenterology diseases. "In the first phase, we have mostly identified medicines from the top 100 drugs based on their sales. These drugs will be made available to 800 select chemists, mostly across Delhi during the first phase. Later the government plans to expand the reach to most metros by the end of the year. The Bureau of Pharma Public Sector Undertakings of India (BPPI), the nodal agency under the department of pharmaceuticals (DoP) for implementing this project, has already floated the tender seeking application for supply of medicines for the programme. The government, along with BPPI, has held consultations with various stakeholders including pharmaceutical firms to ensure there is regular and adequate supply of medicines. The proposal has also been vetted by the doctor fraternity, bringing on board the Medical Council of India as well as the Indian Medical Association to ensure doctors prescribe Jan Aushadhi drugs. ]]> <![CDATA[GSK faces initial resistance following directional shift]]> https://biospectrumindia.com/news/95/4172/gsk-faces-initial-resistance-following-directional-shift.html https://biospectrumindia.com/news/95/4172/gsk-faces-initial-resistance-following-directional-shift.html Thu, 12 Feb 2015 14:42:38 +0530 Following a less than flattering financial performance in 2014, GlaxoSmithKline (GSK) is realigning its operating structure with its corporate objectives and cashing in on its assets in the process, as the company seeks to drive up external investments and deliver stronger shareholder returns in the long term. Excluding divestments, GSK's total revenue fell by 10 percent year-on-year while operating profits were down by 15 percent on a pro forma basis in 2014. While the growing strength of the pound sterling was largely to blame for lower revenues through the first three quarters of the year, a large proportion of the company's decline was inorganic. Ms Chloe Thornton, GlobalData's analyst, states that within its central pharmaceuticals business, GSK's greatest growth resistor was by far its flagship respiratory franchise, which fell by 10 percent year-on-year to just over £6 billion ($9.8 billion), excluding currency impacts. She explained: "GSK invested heavily in developing its respiratory pipeline, but the expectation that it could compensate for the imminent patent cliff facing Seretide/Advair appears optimistic. "Sales of Breo Ellipta came to £67 million ($106 million), while Anoro earned just £17 million ($27 million) in 2014, well short of GSK's estimates." In addition, a further 26 pharmaceutical products witnessed year-on-year declines through 2014, at a total loss of £1.2 billion ($1.9 billion). The analyst notes that despite the strong performance of GSK's cancer therapeutics business, the company has agreed to divest its oncology assets to Novartis, while GSK is also considering divesting a share of its stake in its other best performing business, the ViiV Healthcare joint venture. Ms Thornton continued: "The strength of GSK's oncology portfolio against a backdrop of decline elsewhere across its pharma business somewhat calls into question the decision to trade these assets to Novartis. "However, the $16 billion capital boost GSK will derive from the deal when it is completed over the next few months should help to dispel those concerns, provided the company can proactively invest this capital in areas of high growth potential." ]]> <![CDATA[Pfizer's Hospira acquisition may pave way for generics spin-off]]> https://biospectrumindia.com/news/95/7945/pfizers-hospira-acquisition-may-pave-way-for-generics-spin-off.html https://biospectrumindia.com/news/95/7945/pfizers-hospira-acquisition-may-pave-way-for-generics-spin-off.html Thu, 12 Feb 2015 14:41:45 +0530 On 5 February 2015, just days after gaining the US Food and Drug Administration (FDA) breakthrough approval for Ibrance (palbociclib) in breast cancer, Pfizer entered into an agreement to purchase generic drug maker Hospira for $90 per share in cash, or approximately $17 billion, representing about a 40 percent premium above Hospira's stock price. The deal comes a number of months after Pfizer's failed attempt to acquire AstraZeneca, a move that signaled the company was trying to stem its losses from the patent cliff through inorganic growth means. "The purchase of Hospira is expected to be immediately accretive to Pfizer's earnings, adding nearly $4 billion in sales to Pfizer's Global Established Pharmaceutical (GEP) segment sales of almost $25 billion. Hospira's top-line has been relatively flat over the past six years, growing by a Compound Annual Growth Rate (CAGR) of only about 2 percent. However, the company's Specialty Injectable Products business, of primary importance to Pfizer, continues to perform well," said Mr Adam Dion, GlobalData's healthcare industry analyst. While Hospira's generic specialty injectables product line will be seamlessly integrated into Pfizer's GEP business, Hospira's biosimilar activities are also of key importance to Pfizer's strategic objective. Hospira currently markets three biosimilars in Europe - Retacrit (erythropoietin zeta), Nivestim (filgrastim), and Inflectra (infliximab), the first biosimilar monoclonal antibody to be approved in Europe. Meanwhile, Hospira also has a number of biosimilars in its late-stage pipeline, including trastuzumab (Herceptin), currently in Phase III, which is being evaluated for breast cancer. This is hugely complementary to Pfizer's own ongoing activities in biosimilar development, with biosimilars of Herceptin, Rituxan and Remicade currently in the pipeline. "Although biosimilars have been available in Europe and elsewhere for several years, the US FDA only recently created an approval process for the drugs, which will fuel demand for biosimilars as patents on expensive brand-name biologics expire. Pfizer hopes that by adding Hospira to its portfolio, it will be better positioned to capture a share of the biologics market," Mr Dion further added. It remains to be seen what Pfizer will do with its GEP business after the integration of Hospira. The Hospira deal will add significant value to Pfizer's GEP segment, a vertical which has been rumored to be sold or spun-off as a separate entity. This somewhat mirrors Pfizer's strategic objective to focus on core growth platforms in the branded drug market while divesting its ancillary operations, similar to when it carved-out its Animal Health business (Zoetis) and brought it public. The Zoetis initial public offering was preceded by Pfizer selling its Nutrition business and Capsugel pill unit, mobilizing significant capital for investment in its core growth areas. "However, given Pfizer's desire to retain its pharma leadership and move into biosimilars, it may decide against a split in favor of maintaining a level of operational independence between its innovative and mature portfolios," concluded Mr Dion. ]]> <![CDATA[ 5157 H1N1 cases so far: health ministry reviews ]]> https://biospectrumindia.com/news/95/4171/-5157-h1n1-cases-so-far-health-ministry-reviews-.html https://biospectrumindia.com/news/95/4171/-5157-h1n1-cases-so-far-health-ministry-reviews-.html Thu, 12 Feb 2015 14:40:43 +0530 The status of H1N1 influenza being reported from different states was reviewed today at a high level meeting chaired by the Secretary (Health & Family Welfare) Mr BP Sharma where in addition to the director general, health services (DGHS) Dr Jagdish Prasad, representatives of leading government hospitals such as Dr Ram Manohar Lohia Hospital, Safdurjung, AIIMS, and from Indian Council of Medical Research (ICMR) and National Center for Disease Control (NCDC) were also present. It was noted that that during the period Jan 1, 2015 to February 10, 2015, the total number of H1N1 cases is 5157 and number of deaths is 407. Largely the cases are from Delhi, Gujarat, Rajasthan, Karnataka, Madhya Pradesh, Maharashtra, Tamil Nadu and Telangana whereas largely the deaths due to H1N1 are in Maharashtra, Madhya Pradesh, Gujarat, Rajasthan and Telangana. The current trends of morbidity and mortality, the diagnostic and test algorithms being followed, availability of diagnostic kits and drugs, and other preventive measures were discussed. Based on the advice given by experts it was decided that various health institutions treating H1N1 cases be advised for vaccination against H1N1 influenza for the concerned health workers in the hospitals in contact with H1N1 patients. This will be in addition to the proper personal protective measures being followed at the hospitals. Guidelines are being drafted for vaccination of healthcare workers and these will be shared with the states for dissemination to all health institutions. The government of India has already placed an order for enhancing stock of diagnostic kits to be supplied to the lab network under Integrated Disease Surveillance Programme (IDSP) being used for testing H1N1 influenza. To enhance the level of preparedness, additional 60,000 Oseltamivir medicines and 10,000 N-95 masks are being procured. In addition, NCDC has floated a tender for additional 10,000 diagnostic kits. In case of need, labs under ICMR have been identified across the country to provide additional testing facilities. In order to prevent panic and inconvenience to people, and to encourage only those cases requiring H1N1 testing are actually taken up for testing, it was decided that the communication strategy should create awareness among the general public regarding this aspect. ]]> <![CDATA[BIB 2015: Stem Cells, Bio Medical Innovation, Rare Disease & Orphan Drug Vaccine Research take centerstage]]> https://biospectrumindia.com/news/95/4980/bib-2015-stem-cells-bio-medical-innovation-rare-disease-orphan-drug-vaccine-research-take-centerstage.html https://biospectrumindia.com/news/95/4980/bib-2015-stem-cells-bio-medical-innovation-rare-disease-orphan-drug-vaccine-research-take-centerstage.html Wed, 11 Feb 2015 17:02:09 +0530 The second day of the 15th edition of Bangalore India BIO was dotted with several thought provoking session addressed by key influencers from the industry. The day was dedicated to deliberations on research, diagnostics & collaborations that would create new pathways. There were a few session on Agribiotech that explored the nuances of bioenergy and value addition in agriculture. The Agribiotech Inaugural Session opened with a keynote addressal by Mr Jagadish Patankar stressing on the fact that Biotech has a much larger role to play than just healing the world. Dr KK Narayanan inaugurated the maiden session of the day by giving an overview of what the day has to offer. Dr M Mahadevappa, director (Rural Development), JSSMVP, then went to elaborate on the importance of innovative technology in agriculture and how it can provide tangible solutions to the problems being faced today. Mr Srivatsa Krishna, secretary to Government, Department of IT, BT and S&T and DPAR (e-Governance) Government of Karnataka also shared his vision of taking Bangalore India BIO to a global level next year.Bio Medical Innovations and Diagnostics was attended by organizations like, InnAccel Acceleration Services, Johnson & Johnson Innovation Center, HTIC IIT Madras, Medtronic. The panel shared the best practices and highlighted how the innovation that they have adopted has helped the healthcare sector in India. The Commercialization of Stem Cells: Promises & Public Concerns session was one of the key highlights of the day. Sharing an insight into the evolution of stem cell therapy, Mr Mohan C Vemuri spoke of how the sector has seen major development over the last 14 years. He spoke of how stem cell therapy can help address cardiovascular, orthopedic & inflammatory diseases. The therapy can also be helpful for cancer treatment, allergen response, etc. He ended his addressal on a hopeful note stating that if we advance at this rate, treatment for the same can be made available to general public within the next 20 years. Dr Christian Van Den Bos, spoke about the aspect of commercialization of stem cell therapy and how regulatory frame work can aid the research by tweaking the guidelines a bit. Dr Sanjay Desai, surgeon and professor, MS Ramaiah Medical College and Hospital spoke how stem cell therapy can emerge as the standard for medical care in the future given its non-invasive nature. Ms Geeta Jotwani from the Indian Councilof Medical Research expressed concern regarding the rise of stem cell therapy institution in India whereas none of the Indian stem cell based products has crossed the realm of clinical trials. She went on to elaborate the role that Government policies play in ensuring that the treatments reach the patients as early as possible, while ensuring their efficacy.The Rare Disease and Orphan Drugs Development, Through Establishing The Orphan Drugs Act, session saw participation from a highly balanced panel consisting of doctors, NGOs and corporate sector. Mr Sandeep Sahney, from Genzyme, spoke of how there are 7000 rare diseases in the world and though they are rare, these diseases are chronic, debilitating and can cause death. 80 percent of rare diseases also have a genetic component which makes it more threatening. There are several threats that rare diseases face, few of them are:- There is no prioritization in terms of research, since the diseases affect a very few number of people- There is extremely low awareness about the disease amongst the medical fraternity and doctors- The time gap between first appearance of the symptoms and diagnosis can be as long as 16 years, even in developing countries- The pricing of the treatment is high considering the treatment has to be designed and administered to very few patients The speaker also stressed on the importance of society and Government coming forward to take the responsibility for treatment in such cases. Dr Meenakshi Bhat, Clinical Genetic expert spoke about the importance of importance of knowledge and awareness regarding rare diseases being key to finding a cure. She pointed out that about 30,000 children die before their first birthday, every month, in Karnataka from rare diseases, which makes the research & treatment a huge priority. She also urged the Government and private players to initiate research and aid treatment so that same can be made available to more patients in need. One of the last sessions for the day, US-India Vaccine Research & Collaboration Creating New Pathways saw Emory Vaccine Center, Atlanta & ICGEB, India come together to discuss the nuances of vaccination and preventive measures for common infectious diseases. The discussion provided an overview of the current situation followed by the measures that can be adopted to eliminate these disorders. Second day at the conference saw a conglomeration of best brains in the industry in both India and abroad. The sessions focused on sharing thoughts, insights, best practices and case studies from across the world. The day ended on a rather high note building just the right kind of ambience for the final day of the conference. ]]> <![CDATA[Cipla's UK subsidiary's joint venture with Cooper and PHI ]]> https://biospectrumindia.com/news/95/5495/ciplas-uk-subsidiarys-joint-venture-with-cooper-and-phi-.html https://biospectrumindia.com/news/95/5495/ciplas-uk-subsidiarys-joint-venture-with-cooper-and-phi-.html Wed, 11 Feb 2015 11:26:10 +0530 Global pharmaceutical company Cipla announced that its wholly owned subsidiary, Cipla (EU), UK, has entered into a joint venture (JV) agreement with Cipla's existing business partners in Morocco - Societe Marocaine De Cooperation Pharmaceutique (Cooper Pharma) and The Pharmaceutical Institute (PHI). Cipla has established a strong presence in Morocco for over a decade via its business partners. According to the press release, this JV will enable Cipla to establish a front-end presence in Morocco's pharmaceutical market, becoming the launch vehicle for the company's portfolio while leveraging the commercial strengths of its partners. The initial focus of the agreement would be on respiratory and neurology products and it shall also invest in setting up a manufacturing facility in Morocco. Cipla (EU) Limited's expected investment in cash is estimated to be $15 million. ]]> <![CDATA[FDA Approves Genentech's Diabetic Retinopathy drug ]]> https://biospectrumindia.com/news/95/4099/fda-approves-genentechs-diabetic-retinopathy-drug-.html https://biospectrumindia.com/news/95/4099/fda-approves-genentechs-diabetic-retinopathy-drug-.html Wed, 11 Feb 2015 11:17:17 +0530 Genentech, a member of the Roche Group, announced that the US Food and Drug Administration (FDA) approved Lucentis (ranibizumab injection) for the treatment of diabetic retinopathy (DR) in people with diabetic macular edema (DME). DME impacts nearly 750,000 Americans, about 10 percent of people with DR. Lucentis is a vascular endothelial growth factor (VEGF) inhibitor designed to bind to and inhibit VEGF-A, a protein that is believed to play a critical role in the formation of new blood vessels (angiogenesis) and the hyperpermeability (leakiness) of the vessels. The medicine has been studied in 21 clinical trials worldwide in more than 9,080 patients. Lucentis was developed by Genentech. The company retains commercial rights in the US and Novartis has exclusive commercial rights for the rest of the world. Outside the US, Lucentis is approved in more than 100 countries to treat patients with wet AMD, for the treatment of DME, and due to macular edema secondary to both branch retinal vein occlusion (BRVO) and central retinal vein occlusion (CRVO).The FDA granted Lucentis Breakthrough Therapy Designation and Priority Review for this indication based on results from the RISE and RIDE Phase III clinical trials. The FDA designates Breakthrough Therapy to a medicine if it is intended to treat a serious or life-threatening disease and if preliminary clinical research suggests it may provide substantial improvement on clinically significant endpoints over existing therapies.In the press release, Ms Sandra Horning, MD, chief medical officer and head of Global Product Development had commented that with this approval, people with diabetic macular edema now have a FDA-approved medicine that showed meaningful improvements in retinal damage from diabetes, in addition to the established improvement in vision. ]]> <![CDATA[Karnataka to allow GM field trials ]]> https://biospectrumindia.com/news/95/3928/karnataka-to-allow-gm-field-trials-.html https://biospectrumindia.com/news/95/3928/karnataka-to-allow-gm-field-trials-.html Tue, 10 Feb 2015 18:20:05 +0530 The Karnataka state minister for IT, BT and S&T has announced that the state would allow field trials of GM crops. No timeline or any other detail was mentioned. The safety and efficacy of the usage of GM crops has been under discussion for quite a while now. A newspaper has recently reported that only 4 states have come forward to commercialize Bt Brinjal. Mr Srivatsa Krisha, secretary, Department of IT, BT, Science and Technology, Government of Karnataka, mentioned, "Only Maharastra, AP, Punjab, and Delhi have allowed it. Globally agribiotech would be around a $50 billion market by 2020." He was speaking during the Agribiotech inaugural session on the second day of the Bangalore India Bio 2015. The Modi government which initially had said no to GM crops after overturning regulatory approval of 15 genetically modified crops, made a u-turn barely 2 months later. This was very obvious in the "Made in India" campagin where the govt's focus was on attracting investments India and Abroad. In another session, conducted today morning at BIB, farmers cultivating Bt Cotton spoke about the increase in yield from using GM seeds as compared to hybrid or any other variety. With the Karnataka govt stepping forward, it would be interestinf to see if the trials actually happen in the state, benefitting the farmers. ]]> <![CDATA[BIB 2015: Scaling the Start-ups]]> https://biospectrumindia.com/news/95/3825/bib-2015-scaling-the-start-ups.html https://biospectrumindia.com/news/95/3825/bib-2015-scaling-the-start-ups.html Tue, 10 Feb 2015 17:16:53 +0530 'The Going Beyond Start-Ups with Effective Scaling Strategies' at the Bangalore India Bio 2015 panel discussion saw an attendance from young enterprenuers like Mr Dhananjaya Dendukuri, CEO and co-founder, Achira Labs; Dr Kavitha Iyer Rodrigues, director and COO, Theramyt Novobiologics; Mr Jhenkar Vidyashankar,founder, GridOctane; Mr Nandakumar S, CEO, Perfint Healthcare; Mr Vinay Konaje, founder,NavyaBiologicals; Mr,Mainak Chakraborty,Founder-Director, Green Power systems. The panel shared their scaling strategies that has led to positive growth of their start-up venture. The panel also put forth their demand to the Government requesting procurement sources to accommodate start-up companies, Government considering investment in them and creating a platform to identify and nurture start-ups. "It would be great if government could consider equity investment as opposed to loans," said Mr Dhananjaya Dendukuri, CEO and co-founder, Achira Labs. According to Mr Vinay Konaje, founder, NavyaBiologicals, "Regulatory process, which is the most important part of drug discovery should be much more rule-based, that I guess would be very effective." Since lifesciences is an interdisciplinary science, collaboration is required for fruitful research, the panel concluded. ]]> <![CDATA[A lot going on at the health policy level: Joint health secretary ]]> https://biospectrumindia.com/interviews/95/3730/a-lot-going-on-at-the-health-policy-level-joint-health-secretary-.html https://biospectrumindia.com/interviews/95/3730/a-lot-going-on-at-the-health-policy-level-joint-health-secretary-.html Tue, 10 Feb 2015 15:43:56 +0530 To the question of latest happenings at the health ministry vis a vis policy changes, Mr KL Sharma, joint secretary (regulations), ministry of health and family welfare, mentioned, "There are a lot many initiatives going on at the moment. There is the Food and Cosmetics Bill which is in the public domain for consultations and it has received comments across the globe. The health policy draft too is attracting queries." On being asked about the priorities in 2015, Mr Sharma remarked, "Basic challenge is to take care of new and emerging diseases. As we are over a period of time increasing the prosperity of the country, priorities are shifting towards lifestyle diseases. In the rural settings, basic health infrastructure is missing in some places. Those will be the focus areas. Essentially, the strengthening of the existing ones and to be able to provide new medical tourism." On better regulations, Mr Sharma added, "We would also like to enhance the regulatory structure, the kind of laboratories we are having including those in central and private facilities. We are going to put in a lot of resources there. We are going to spend Rs 2,000 crore in schemes aimed at revamping the regulatory structure. We are also going to relook at the clinical trials structure." ]]> <![CDATA[BIB 2015: GM Myth vs Reality]]> https://biospectrumindia.com/news/95/5513/bib-2015-gm-myth-vs-reality.html https://biospectrumindia.com/news/95/5513/bib-2015-gm-myth-vs-reality.html Tue, 10 Feb 2015 15:36:00 +0530 A farmer from Tamil Nadu, Mr VKV Ravichandran narrated his experience of growing BT cotton in his fields. According to him, there are a lot of myths surronding the BT cotton among farmers. In his presentation, he compared BT cotton vs hybrid cotton vs different varieties of cotton. "I can say that the yield per acre for BT cotton is 1,300 kgs (approximate values only) where as hybrid has got us 1,150 kgs and variety cotton is 1,000 kg per acre. Picking cost for BT cotton was around Rs 9,100, Rs 8,050 for Hybrid and for Variety, it was Rs 7,000. Overall net sale value that I got from BT cotton is Rs 53,300, Rs 46,000 for Hybrid and Rs 40,000 for variety cotton." He was speaking at the Bangalore India BIO addresing the session "Farmer's perspectives and public perception". He also said that some farmers say that we need to pay more price for BT cotton seeds. "Yes, maginally we pay a higher price for BT cotton seeds. But the fact is seed cost should not be seen in isolating other farmers. Other factors also must be considered," he added. He appealed to his fellow farmers that in a single crop, namely cotton, with a single trait namely pest resistence we are able to dominate the cotton market in the world. If we are provided more number of crops with different traits, we can capture the world." Echoing his thoughts, a farmer from Gulbarga, Mr Sudhindra Kulkarni, said that he has been growing BT cotton since 2004. "Earlier, due to high pest problems, we had discontinued growing cotton. After hearing about BT cotton, we started growing it in our fields. I am benefitting out of it and I have started a 'Council for Rural development and Agriculture Technology (CRAT) in Gulabarga and am encouraging other farmers to go for BT Cotton." He urged the government of Karnataka to introduce GM field trials for other crops. In his address to the gathering, State Agriculture Minister Mr Krisha ByreGowda urged academia and scienticfic community to come up with a non-GM biotech crop procedure. "There is a lot of debate among people on GM crops. Some are for and some are against it. However, Agribiotech does not necessarily have to be only from a genetically modified method. People should consider non-GM biotech crops." Mr Ullas Karanth, director, Center for Wildlife studies, said that GM crops do not harm biodiversity. "Some say that GM will harm the biodiversity. However, I have to say that several other factors are threatning biodiversity. There is a element of risk in every discovery or innovation. We need to safeguard for such risks," he said. Mr Narayanan Suresh, group editor for BioSpectrum India and Asia said that GM entry into the food crops are having issues because food is a sensitive issue. Today, GM has entered in to the lifestyle and pharma sectors. "The new union government has allowed confined field trials in four states. Yesterday, Karnataka minister for Science and Technology, IT, BT, Mr Patil said that Karnataka too will allow field trials of GM crops. It is a matter of time that this will be accepted by all." He also refered to a recent consumer study in the uS where consumers are fine with and accept GM food as along as they are healthy and nutritious. ]]> <![CDATA[BIB 2015: Experts talk Agribiotech on day 2 ]]> https://biospectrumindia.com/news/95/3676/bib-2015-experts-talk-agribiotech-on-day-2-.html https://biospectrumindia.com/news/95/3676/bib-2015-experts-talk-agribiotech-on-day-2-.html Tue, 10 Feb 2015 15:02:47 +0530 "In India, farmers who are using BT Cotton have seen additional profits of Rs 45,000-50,000 crore," said Mr Ram Kaundinya, chairperson of ABLE-AG during the Agribiotech inaugural session on the second day of the Bangalore India Bio 2015. He further said that GM seeds are coming in Rice, Pulses, and Oilseeds in India. "Due to non-scientific reasons BT Brinjal adoption and field trials have been stopped. Industry and the government have made a huge investment to the tune of over Rs 12,000 crore on GM and they are waiting for returns. Policy makers need to look into this for the larger benefit of farmers and people", he added. "Stopping field trials is not the answer. We need to use the technology responsibly. We hope policy makers take a note of it," he said. Earlier, Mr M Mahadevappa, director (Rural Development), JSSMVP, Mysore and ex-chairman, ASRB, ex-vice chancellor UAS, Dharwad, said that a day will come when all GM crops will be accepted. He also urged that efforts need to be made so as to not send wrong information across society on biotech crops. Farmers need to be educated on the benefits of Agribiotech, he felt. Mr Srivatsa Krisha, secretary, Department of IT, BT, Science and Technology, Government of Karnataka said that only four states in India have allowed field trails of GM crops. "Only Maharastra, AP, Punjab, and Delhi have allowed it. Globally agribiotech would be around a $50 billion market by 2020," he said. Quoting a report in a newspaper, he said that the article states that no Indian state has come forward to commercialize BT Brinjal, he went on to say that it wasa a matter of concern and something that needed checking. He also said that the Government of Karnataka under the aegies of the Agricluture Minsiter is looking to establish a vision group for Agribiotech in the state. Duriong his note, he said his department is contemplating making Bangalore India Bio an international event. "We are looking at the feasability of making the next edition an Asia edition, hosted in one of the Asian countries," he said. ]]> <![CDATA[BIB 2015: Dr Rajaram on the agricultural needs of the country]]> https://biospectrumindia.com/news/95/6036/bib-2015-dr-rajaram-on-the-agricultural-needs-of-the-country.html https://biospectrumindia.com/news/95/6036/bib-2015-dr-rajaram-on-the-agricultural-needs-of-the-country.html Mon, 09 Feb 2015 15:49:52 +0530 Agriculture is among the greatest contributors to global warming, emitting more green house gases that all cars, trains and airplanes combined. This is largely from the methane release by the cattle digestive process. Also, when animals' manure is stored or managed in lagoons or holding tanks, Methane (CH4) is produced. Because humans raise these animals for food, the emissions are considered human-related. "Globally, the Agriculture sector is the primary source of Methane emissions," said Dr Sanjay Rajaram, World Food Prize Laureate 2014, speaking at the Inaugural session of Bangalore India Bio 2015. Speaking on the Food demand in 2050, he said, the world roughly needs crops the size of South America, livestock roughly the size of Africa and we need to avoid further deforestation and grow more on existing farm land. "We have to use resourse efficiently. Conservation agricluture including organic farming may reduce the use of water and chemicals and replacing the inefficient irrigation system with more precisie methods like subsurface drip irrigation has to be the priority," he said. Speaking on the wheat production in India, Dr Rajaram said that India's wheat production in 2014 is 96 million metric tonnes. "Demand by 2050 would be 160 million tonne," he added. In such a case, possible technology options would be hybrid wheat, biotech/GM, he said. Refering to the recently released ISAAA report, he mentioned that today's world has 27 biotech crop countries. "Seven million farmers in China and India and a record 18 million farmers in 27 countries have plated 175.2 million hectares of biotech crops in 2013, a sustained increase of 5 million hectraes every year." he said, adding further, Maize and Soyabean are currently largest producers of biotech crops in the US. Urging the Karnataka government, Dr Rajaram said our immediate task would be to alleviate the constratits of agricultural education. "State governments should develop a mechanism to upgrade the curriculam on a regular basis; Strengthen the link between teaching, research and extension; reducing time lapse between research education and extension and enhance entrepreneurship." The next generation revolution that is in next 10-15 years is that GM crops will extended to Rice, Wheat, Oilseeds, and other major crops not limiting itself to fruits and vegetables, he added. Concluding his keynote, he urged the India government to invest in GM technology, hybrid technology, introduce innovation in family farming, help farmers to restore soild health, introduce large scale mechanization on small farms and educate future agricultural scientists and academics in India. ]]> <![CDATA[Patent for 'Vancoplus' from Venus Remedies ]]> https://biospectrumindia.com/news/95/4595/patent-for-vancoplus-from-venus-remedies-.html https://biospectrumindia.com/news/95/4595/patent-for-vancoplus-from-venus-remedies-.html Mon, 09 Feb 2015 15:00:31 +0530 Venus Remedies has received a product patent grant for its unique antibiotic research product, Vancoplus, from the Indian Patent Office (IPO). The patent is valid till 2025. Commenting on the achievement, Dr (Mrs) Manu Chaudhary, joint managing director, Venus Remedies, and director, Research, Venus Medicine Research Center (VMRC), the company's R&D wing, said, "It took the VMRC more than seven years to develop this product. It is one of the best and safest options to get rid of drug-resistant gram-negative and gram-positive bacteria, including methicillin-resistant Staphylococcus aureus (MRSA), vancomycin-intermediate Staphylococcus aureus (VISA) and heterogeneous glycopeptide-intermediate Staphylococcus aureus." The total global market size of MRSA-associated infections is around $9 billion. At present, it is growing at a compounded annual growth rate (CAGR) of 4.8 percent, which is estimated to go up to 12.4 percent by 2017. In India, Vancoplus is projected to cater to a market of Rs 214 crore by Vancoplus is a novel antibiotic adjuvant entity that is highly effective against the notorious MRSA bacterial strain and multi-drug resistant microbes primarily responsible for causing infections like meningitis, pneumonia, typhoid, septicemia, urinary tract infections, skin infections and staphylococcal endocarditis. It is also active against different mechanisms of resistance, such as cell membrane impermeability, efflux pumps and biofilms, which no other existing therapeutic options available in the market are able to tackle. "Vancoplus is the need of the hour due to its high efficacy against such infections. Considering the rising prevalence of MRSA, VRSA and hGISA infections, we are hopeful that this patent for Vancoplus will help us capture a significant market share," said Dr Manu Chaudhary. The company has conducted clinical trials for this drug on a large patient sample size to prove its clinical efficacy and safety, which is further validated by publications in peer-reviewed journals. Venus has more than 15 research papers on this product to its credit. So far, the company has received patents for Vancoplus from more than 18 countries, including the USA, Japan, South Africa, New Zealand, Ukraine, Australia, and South Africa. It is holding advanced-level discussions with some multinational companies for the outlicensing of this product. ]]> <![CDATA[Innovation needed for effective healthcare delivery ]]> https://biospectrumindia.com/news/95/5816/innovation-needed-for-effective-healthcare-delivery-.html https://biospectrumindia.com/news/95/5816/innovation-needed-for-effective-healthcare-delivery-.html Mon, 09 Feb 2015 13:18:00 +0530 "There is an equal need for sharing of best practices between various stakeholders in the health sector in order to benefit from the prevalent knowledge and experience in different quarters," stated the Union Health Minister, Mr JP Nadda at the Third Biennial International Conference and Advanced Live Laparoscopic Workshop- ENDOLAP 2014, organized by the Maulana Azad Medical College, New Delhi, on February 07, 2015. Stating that laparoscopy is a skilled surgery which required advanced training, the Health Minister highlighted the gap between the demand and supply in human resources in the health sector including doctors, specialists, and para-medical professionals. With more opportunities for advanced training in such specializations, not only will the demand-supply gap be reduced but the patients will also benefit with better healthcare, the Minister pointed out. The Government is working on plans for holistic healthcare which include creating infrastructure at the primary, secondary and tertiary levels in addition to providing better healthcare services in the rural areas, the Minister mentioned. The Health Minister said that workshops such as these with participation of eminent national and international faculty provide an opportunity to the students and faculty to deepen their knowledge and sharpen their skills. The Minister invited suggestions from doctors and other stakeholders for enhancing the effectiveness of healthcare delivery in the country. Also present at the conference were Mr SCL Das, health secretary, Delhi Government; Dr MC Misra, director, AIIMS; Dr Deepak Tampe, dean, MAMC along with students and faculty of MAMC. More than 200 delegates are participating in the three-day conference. ]]> <![CDATA[The 15th edition of Bangalore India BIO begins]]> https://biospectrumindia.com/views/95/5754/the-15th-edition-of-bangalore-india-bio-begins.html https://biospectrumindia.com/views/95/5754/the-15th-edition-of-bangalore-india-bio-begins.html Mon, 09 Feb 2015 12:35:00 +0530 The 15th edition of India's premier biotech event, Bangalore India Bio 2015 was inagurated by Mr Siddaramaiah, the Chief Minister of Karnataka; Mr Prakash Javadekar, Minister of state-Environment, Forest and Climate Change, Government of India; Mr Piyush Goyal, Minister of state for Power, Coal and Renewable Energy, Government of India. The inaugural event was also graced by the presence of Mr SR Patil, Minister for Planning and Statistics, IT, BT, Science and Technology, Government of Karnataka; Mr Dominic Jermey, chief executive, UK Trade and Investment and Vision group members from Biotechnology, Karnataka. Jointly organized by the Department of IT, BT and Science & Technology, Vision Group Biotechnology and MM Activ Sci-Tech Communications. The focal theme for this year's summit is "Crystallizing India's Biotech Future". This edition has over 22 conference sessions, 110 impact speakers, over 3,000 visitors and 15 international delegations from the UK, USA, France, Germany, Holland, Singaporte, Korea, Japan, and Australia. In his inaugural address, Mr Siddaramaiah spoke about the government's efforts in making Bangalore the Biotech hub of India. Speaking on the occasion, Mr Javadekar urged the industry to innovate, saying, "Innovation is the key for sustainability and growth." He also said that his government is looking at generating power from 'Green' coal (from waste) in Andaman islands. "Today, Biotechnology can help in improving soil health, improve water quality. Again on health care world is looking at preventive medicines," said Mr Piyush Goyal. He asked the Karnataka government to switch to LED bulbs for street lights to save evergy. There will be several sessions spread over these three days. Some of the key topics of discussion during these sessions include, Agri-Biotech, Clinical trials in India and Rare diseases & Orphan Drug Development. US-India vaccine research & collaboration and going beyond the Start-up with effective scaling strategies - a special pavilion dedicated to start-ups. ]]> <![CDATA[Can Indian companies be on Pfizer's next acquisition spree?]]> https://biospectrumindia.com/views/95/4790/can-indian-companies-be-on-pfizers-next-acquisition-spree.html https://biospectrumindia.com/views/95/4790/can-indian-companies-be-on-pfizers-next-acquisition-spree.html Mon, 09 Feb 2015 09:25:00 +0530 Pfizer has been fairly subdued since the AstraZeneca deal collapse. "Whether this is indicative of the fact that it is biding its time to repeat the attempt to secure AstraZeneca's assets or rethink its corporate strategy, remains to be seen. The financial benefits of an AstraZeneca deal have been impacted by changes to the US tax laws regarding repatriation of overseas earnings, and the company might therefore look closer to home as far as external investment opportunity goes," says analyst Mr Joshua Owide, GlobalData's director of healthcare industry dynamics.Biologics and specialty diseasesWhile many big pharma companies pursue a path of smaller-scale biotech acquisitions, Pfizer appears intent on retaining its large-scale M&A model. "Pfizer might look at companies such as BMS Bristol-Myers Squibb or Eli Lilly, to expand its base business. Recent market movements have made a number of US biotech companies extremely costly as potential targets, and so more established, large-scale companies with greater opportunity for cost-stripping could present a more appealing investment opportunity. Those companies operating in biologics will undoubtedly be brighter on Pfizer's radar," said Mr Owide. Again, biologics will be a key focal point, similar to the Wyeth deal a few years ago, while companies with strong development pipelines will be of particular interest, given Pfizer's own shortcomings in terms of new product developments. Mr Owide commented that Pfizer has struggled to match its size through R&D and is therefore particularly reliant on external innovation to maintain its position as a global pharmaceutical leader. "Despite Pfizer's historical presence in primary care diseases, the company is shifting increasingly towards specialty diseases, and this will also play a major role in determining its future acquisition targets," explained Mr Owide. India or China? What about developing markets like India or China? Will Pfizer cast its shadow on these markets this year? Analysts say that there is always potential for companies to invest in emerging markets, notably in India, where the generics market is thriving. "Pfizer's commitment to innovative medicines will likely mean its focal point remains in the developed markets with regard to headline M&A deals," remarked Mr Owide. AZ deal resurrected? Another question that has been plaguing many minds in the industry is, will Pfizer make a comeback this year on its failed bid with AstraZeneca? Analysts think it could be feasible. However, the new US tax laws could be a major deterrent, as financial engineering was one of the major drivers behind Pfizer's record bid for AstraZeneca. Also, is it possible for Pfizer's M&A strategy to backfire at some point? There is an element of repeating the same action and expecting different results. Mr Owide opined, "Pfizer's approach has persistently failed to foster innovation and expand its intellectual property libraries in a truly meaningful way, meaning there are doubts as to how sustainable this approach can be." However, Pfizer will always look to deals with significant synergies, and those will largely be around manufacturing and commercial infrastructure, which is unlikely to change. The knock-on effect of Pfizer's deal-making more directly relates to its acquisition targets and their employees, rather than its own workforce. The AstraZeneca deal was slightly unique compared to its previous acquisitions, in that a large proportion of value was related to pipeline assets. So rather than simply strip out costs, it would have had to foster innovation in order to accrue the underlining value from the deal. Financial engineering Generally speaking, financial engineering has been a fundamental driver behind the upsurge in M&A deals, with companies able to offer significant premiums on the basis of accruing higher future earnings through lower tax rates. The upsurge in approvals has also been an encouraging force, with companies looking to secure novel compounds at the earliest possible opportunity. Innovation lost? Focusing on the innovation part, M&As can work in two ways. Acquired companies with a history of innovation are increasingly operated as wholly-owned subsidiaries, rather than simply asset-stripped. "This is more fruitful in terms of sustained levels of innovation, as these companies and their employees are typically specialized in their fields," noted Mr Owide. Perfect examples of this model include Genentech (Roche), Genzyme (Sanofi) and Millennium (Takeda). However, M&A that is largely focused on asset-stripping and operational synergies are much more damaging in terms of innovation. The value of these deals, while high, is largely tied to those assets already on the market or in late-stage development. ]]> <![CDATA[â€œWe are debating only one aspect of GM cropsâ€?]]> https://biospectrumindia.com/interviews/95/5966/we-are-debating-only-one-aspect-of-gm-crops.html https://biospectrumindia.com/interviews/95/5966/we-are-debating-only-one-aspect-of-gm-crops.html Sun, 08 Feb 2015 09:16:00 +0530 Speaking to the BioSpectrum, he agreed that the public institutes have to do better valued research than 20 years back. Below are the excerpts: Q: How do you look at the debate around GM crops now? Has the scenario changed in the last few years?Dr Datta: We lost a decade as there is a negative environment around GM research. People started moving to matrix assisted selection (MAS) and other techniques as they were reluctant to continue research due to the controversies surrounding it. But the fact is that just like the plant biotech experiment cannot be done without Arabidopsis thaliana, the GM products have to be equally commercialized after a safety evaluation. Also, public institutes have to do better valued research than what it used to 20 years back. Improvement is required as I feel that we have failed to understand actual biotech research. At the same time, GM will take time and we should not be disheartened. Today, motivation is lacking and many think it is a MNC-based technology. But it has to be known that India, being such a large country cannot be dependent only on public companies to feed its population. Private sector including indigenous ones, has to play a key role. Q: What about the criticism on Bt Cotton? Couldn't Bt Brinjal have been a success also?Bt cotton is a successful example. However, it was an illegal crop legalized later and perhaps Bt crop will face the same. Bt Brinjal was almost approved but only a single minister halted it. He overstepped his role and side-lined GEAC decision. It is important to note that it is growing well in Bangladesh now. Q: Don't you think biodiversity is an important aspect that requires to be taken care of? Why do activists cry foul over the issue?Biotech is an extension of plant breeding. In the threat of climatic changes, lies the opportunity for biologists. There are 4 lakh germplasms at the National Institute of Plant Genome Research (NIPGR) which perhaps would be never utilized. Biodiversity has to be understood in the proper perspective. It hurts as a biologist that only one aspect of biodiversity is being talked about. But we have to understand the importance as scientists. Twenty two thousand wheat germplasms are being analyzed. The exports are up as during 2013-14, $23 billion worth food has been exported. 10 million tonnes of rice and $ 4.6 billion worth basmati alone has been exported. From an importing country, we have become an exporting nation. Activists have not understood the importance of GM crops and the need to strike a balance between it and biodiversity. Its benefit is going to the farmers and people who brought it to the commercial angle. However, safety too is equally important and needs to be taken care of. Q: Do you agree with Dr M S Swaminathan's assertion that ICAR must come forward to discuss the GM issue more often? What is the way forward on the issue? I fully agree with Dr Swaminathan's assertion in this regard. The GM has to come and it is going to be there as a technology irrespective of this debate. In fact, we are just debating only one aspect and that is to be or not to be. The question should be of sharing and benefitting of technology. It is how we can govern and resources can be utilized. We are debating only one aspect and to me it is stupid to highlight only the controversial part and avoid discussing the benefits. The maximum benefit is to be shared by farmers, growers, and consumers. Farmers must have access to user friendly and consumer friendly technology at an affordable price. The government has to intervene and govern in a systematic manner. Q: How do you look at the regulatory chaos? Don't you think it is leading to a loss of the taxpayer's money? The Biotechnology Regulatory Authority of India (BRAI) bill has to come to the Parliament and once passed, it would boost the sector. But to me, more investment has to reach public sector and more young people in research have to come forward so that there is ownership development. Many people think that the Indian government gives only money for farmers but it is actually rather the policy interventions that help in giving new incentives to grow and distribute hybrids. The biggest taxpayer's money is available in the public domain. India is a vast country and we obviously cannot put a restrictive policy here as compared to a small country. Our country is an open state with an inclusive agriculture policy. In India, it is important that we keep the federal structure alive so that we can identify new developments to come. These developments come to a level that people know the minimum support price, procurement policy, and market strategy. As PM Modi talks about real-time agriculture growth, it means connection with the world markets. Now a lot of people do not understand that. The awareness and profit sharing is the next phase. Q: How successful has been the open access policy of ICAR? What are the challenges?Access to journals and the suggestions from public have increased since the open access policy at ICAR. The information about new varieties developed, technological interventions, and government funding has benefitted the farmers and researchers alike to increase yield. Research papers have helped readers know about Indian agriculture. Lot of these papers are being traced to know technological interventions and government policies. This is a huge country with variable agriculture policies at the state level. It is important to keep federal policies in alignment with the foresight on agricultural methods in the next 11-15 years. There is need to bring awareness to farmers. Besides that I feel the IP policy and profit sharing are important. It has not been practised in India so far. Therefore, it is important to keep the guidelines clear while implementing open access policies. ]]> <![CDATA[â€œLooking for Indian partners to work on malaria vaccineâ€?]]> https://biospectrumindia.com/interviews/95/4543/looking-for-indian-partners-to-work-on-malaria-vaccine.html https://biospectrumindia.com/interviews/95/4543/looking-for-indian-partners-to-work-on-malaria-vaccine.html Sat, 07 Feb 2015 09:08:00 +0530 Besides his outstanding academic credentials, he is also the co-founder of Ancora Pharmaceuticals. During his visit to India as a part of the delegation of 'Australia Business Week in India', he spoke to BioSpectrum on his malaria vaccine development program and India as a land of opportunity. Q: What is the scope of your work and how has your India experience been so far?Apart from the research to tackle the endemic tropical diseases such as melioidosis, Q fever, drug-resistant Staphyloccoccus aureus, group A Streptococcus and pneumonia that are prevalent in the tropical areas of Australia (which consist of 40 percent of land), and our institute has a great responsibility towards the pacific region. There is very clear reason to engage with the developing Asian nations including India. As an institute, we have lot of capacity in vaccine development and our portfolios can be very helpful in taking ahead our efforts. And during this course, India is an absolute natural choice in seeking commercial partnerships to develop vaccines of our choice. Besides that we have other capacities in tropical health and we expect these to be utilized here in India. There are many points of synergy for cooperation and we are committed to engage with India among other countries in Asia.Q: What has been the progress on the malarial vaccine initiative at your institute? What is new?We have two malarial vaccine portfolios. One is going for the clinical trials immediately and the other one is in development. It is the latter one for which I am seeking Indian partnership. This is based on polysaccharide conjugate vaccine technology that is mostly used in India. As we know the real problem is that it is difficult to find a vaccine solution for malaria, I have worked all my life without success. The malarial strategy is about complexity, diversity, change in pathway of motile infective form, sporozoite in blood. A sporozoite travels through the blood vessels to liver cells and reproduces there to form merozoites. Therefore, it is difficult for immune system to track the parasite. Also, there are five species and you can immunize against one but what about the four more. The solution is to find one antigen at every stage in each specie. It sounds impossible but then there is one polysaccharide. It is the only one produced by malaria pathogen conserved at every stage and in every specie. It is our exclusive finding and we have comprehensive IP position on it. We have done a lot of pre-clinical evaluation on it in rodent model systems and it has shown complete protection when immunized. Every time we have done it, we found it prevents the sporozoites to get into blood. There is data which is very exciting and motivates us to do more. Q: What kind of challenges and opportunities do you find in Indian market?Australia has a very strong innovation base and basic research capacity but the translation is not there. India has got great manufacturing strength and we are here to leverage it. The challenges are not so problematic here. In fact, the major one for me is that as a scientist I have to talk about business too and that is a personal growth as well.India has got culture to promote the appropriate technology. Of course, this gets back to its father of nation, Mahatma Gandhi. I see commitment towards humanitarian issues. It is not just about making money but concern for the global health or disease burden. We are working on malarial vaccine and of course there is some money concern but then our commitment is towards the global issues. I don't care much about challenges as I am an optimist. There are many areas where there can be great deal of partnership between India and Australia. In malaria, India has got outstanding work. Our scientists work in the area of tuberculosis (TB), malaria and diabetes. So the opportunities are plenty to collaborate. Q: Are you looking at having collaboration on malaria vaccine? Any possible interaction so far?Of course I am looking for an Indian partner who has the required expertise. I am aware about the efforts at the International Centre for Genetic Engineering and Biotechnology (ICGEB),New Delhi and have a great deal of respect for what they are doing on vaccines. I have been in talks with the eminent scientists working on malarial program there and will be absolutely talking to them more in future as well. ]]> <![CDATA[Can Indian companies be on Pfizer's next M&A spree?]]> https://biospectrumindia.com/features/95/6707/can-indian-companies-be-on-pfizers-next-ma-spree.html https://biospectrumindia.com/features/95/6707/can-indian-companies-be-on-pfizers-next-ma-spree.html Fri, 06 Feb 2015 18:12:26 +0530 Pfizer has approximately $15 billion of sales at risk from generic/biosimilar competition over the next 5 years, with the biggest losses expected to be suffered by its drugs including Lyrica, Zyvox, Viagra and Vfend. Despite the recent approval of Ibrance (palbociclib), Pfizer's late-stage pipeline is relatively weak, and the move to acquire Hospira will help insulate its top-line from the impact of patent expirations. Ever since its failed acquisition talks worth $118 billion with British-drug major AstraZeneca (AZ) in 2014, industry analysts speculated a wide range of possibilities for the pharma giant's next acquisition this New Year. The new announcement from Pfizer has arrived just in time. Pfizer was fairly subdued since the AstraZeneca deal collapse last year. "Whether this is indicative of the fact it is biding its time to repeat the attempt to secure AstraZeneca's assets, or rethink its corporate strategy, remains to be seen. The financial benefits of an AstraZeneca deal have been impacted by changes to the US tax laws regarding repatriation of overseas earnings, and the company might therefore look closer to home as far as external investment opportunity goes," predicted analyst Mr Joshua Owide in January 2015, who is GlobalData's director of healthcare industry dynamics. Hospira is an established biosimilars developer, most notably in Europe, where it already markets three biosimilars - Retacrit (erythropoietin zeta), Nivestim (filgrastim), and Inflectra (infliximab), which was the first biosimilar monoclonal antibody (mAb) to be approved in Europe. Hospira also has a number of biosimilars in its late-stage pipeline, including trastuzumab (Herceptin), currently in Phase III, which is being evaluated for metastatic breast cancer. "This complements Pfizer's own foray into biosimilars, with development ongoing for copies of Herceptin, Rituxan and Remicade," added Mr Owide. Biologics vs Biosimilars Although biosimilars have been available in Europe and elsewhere for several years, the US Food and Drug Administration (FDA) only recently set out the pathway for the approval of biosimilars, coinciding with both the ramping up of biosimilar development programs and the wave of expirations impacting a number of major established biologic therapeutics. Mr Owide thus commented, "Pfizer will hope that by adding Hospira's expertise in the field of biosimilars, it will be better positioned to take market share in the lucrative biologics space." While many big pharma companies pursue a path of smaller-scale biotech acquisitions, Pfizer appears intent on retaining its large-scale M&A model. Pfizer, in 2009, shelled out a whopping $68 billion to buy Wyeth, which had a portfolio of biotech drugs. Analysts conclude that Pfizer will continue to accrue significant value from its acquired assets through cost stripping exercises following consolidation. "However Pfizer's dependency on inorganic growth has become hugely repetitive and highlights the company's need to more actively invest in external assets earlier on in the product lifecycle and drive greater in-house R&D productivity," said Mr Owide. Again, biologics will be a key focal point, similar to the Wyeth deal a few years ago, while companies with strong development pipelines will be of particular interest, given Pfizer's own shortcomings in terms of new product developments. The exponential growth of the biologic segment over the past decade or so has placed a significant burden on the US healthcare economy, given the high price of biologic medicines compared with more conventional small molecule therapies. While biosimilars are not expected to launch with the same level of price discounting as generic small molecules, the continued move towards cost containment will ensure that there is room for biosimilars in the US. Furthermore, biosimilars will possess significant revenue-generating capacity for the companies that market them. Mr Owide comments that Pfizer has struggled to match its size through R&D and is therefore particularly reliant on external innovation to maintain its position as a global pharmaceutical leader. "Despite Pfizer's historical presence in primary care diseases, the company is shifting increasingly towards specialty diseases, and this will also play a major role in determining its future acquisition targets," explained Mr Owide. India or China? What about developing markets like India or China? Will Pfizer cast its shadow on these markets this year? Analysts say that there is always potential for companies to invest in emerging markets, notably in India, where the generics market is thriving. "Pfizer's commitment to innovative medicines will likely mean its focal point remains in the developed markets with regard to headline M&A deals," remarked Mr Owide. A number of Pfizer's peers are actively developing biosimilars, and they will be conscious of the benefits that Pfizer's biosimilar proposition will derive from the deal, with Hospira not only active in biosimilars, but also very active in oncology specialty injectables. This will improve Pfizer's access to the necessary prescribing channels when its oncology biosimilars, namely Herceptin and Rituxan, gain approval. AZ deal resurrected? Another question that has been plaguing many minds in the industry is, will Pfizer make a comeback this year on its failed bid with AstraZeneca? Analysts think it could be feasible. However, the new US tax laws could be a major deterrent, as financial engineering was one of the major drivers behind Pfizer's record bid for AstraZeneca. Also, is it possible for Pfizer's M&A strategy to backfire at some point? There is an element of repeating the same action and expecting different results. Mr Owide opined, "Pfizer's approach has persistently failed to foster innovation and expand its intellectual property libraries in a truly meaningful way, meaning there are doubts as to how sustainable this approach can be." However, Pfizer will always look to deals with significant synergies, and those will largely be around manufacturing and commercial infrastructure, which is unlikely to change. The knock-on effect of Pfizer's deal-making more directly relates to its acquisition targets and their employees, rather than its own workforce. The AstraZeneca deal was slightly unique compared to its previous acquisitions, in that a large proportion of value was related to pipeline assets. So rather than simply strip out costs, it would have had to foster innovation in order to accrue the underlining value from the deal. Pfizer's Split? Earlier, Pfizer's senior management had mentioned plans about the company splitting into two. "A separation would undermine Pfizer's mantra of being the world's number one drug company, but could make sense from strategic, financial and operational standpoints," Mr Owide stated. Generally speaking, financial engineering has been a fundamental driver behind the upsurge in M&A deals, with companies able to offer significant premiums on the basis of accruing higher future earnings through lower tax rates. The upsurge in approvals has also been an encouraging force, with companies looking to secure novel compounds at the earliest possible opportunity. Pfizer's move away from primary care towards specialty care will be helped immensely by the integration of Hospira's specialty injectables business. The company is unlikely to discontinue any of the product lines it has acquired, and it will rather focus on turning them around to make it profitable. Innovation lost? Experts believe that M&As can work in two ways. Acquired companies with a history of innovation are increasingly operated as wholly-owned subsidiaries, rather than simply asset-stripped. "This is more fruitful in terms of sustained levels of innovation, as these companies and their employees are typically specialized in their fields," notes Mr Owide. Perfect examples of this model include Genentech (Roche), Genzyme (Sanofi) and Millennium (Takeda). However, M&As that is largely focused on asset-stripping and operational synergies are much more damaging in terms of innovation. The value of these deals, while high, is largely tied to those assets already on the market or in late-stage development. As with any acquisition on this scale, Pfizer will identify overlapping functions where significant cost savings can be realized and axe employees as per its requirements. ]]> <![CDATA[Govt appoints Dr MO Garg as new DG of CSIR]]> https://biospectrumindia.com/news/95/7754/govt-appoints-dr-mo-garg-as-new-dg-of-csir.html https://biospectrumindia.com/news/95/7754/govt-appoints-dr-mo-garg-as-new-dg-of-csir.html Fri, 06 Feb 2015 16:04:47 +0530 The Modi government has heeded the criticism on adhoc appointments in the top position of the premier scientific body of the country. It has now appointed Dr MO Garg as director of CSIR-Indian Institute of Petroleum, Dehradun as the new director general of the CSIR. Dr Garg has 37 years of experience in the refining and petrochemical industry. The post was technically lying vaccant since more than a month. Dr Garg's predcessor, Dr PS Ahuja retired on December, 31, 2014. The previous regime had tried to appoint a full time new director general after Dr Samir Brahmachari but the issue got entangled in various controversies. Following that Dr T Ramasami, then secretary of DST held the post for a brief period and post his retirement, Dr PS Ahuja was given an extension to hold the post. Dr Garg started his career in the Research and Development Division of Engineers India Ltd in 1976. He did his PhD at University of Melbourne in the area of Solvent Extraction. In 1994, he joined Process System Services Division of KTI-Technip India Ltd. and joined Indian Institute of Petroleum in 1998. Dr Garg has developed and commercialized several technologies and has received two CSIR Technology Awards as well as a CSIR Shield for his commercialization efforts. He has contributed immensely to the growth of Indian refining industry in various ways. He has published over 213 papers and has 26 patents to his credit. He has been elected Fellow of Indian National Academy of Engineering. Dr Garg has been invited both in India and abroad to give lectures in prestigious conferences. ]]> <![CDATA[Agri-experts remind government of decisive policy on GM]]> https://biospectrumindia.com/news/95/5775/agri-experts-remind-government-of-decisive-policy-on-gm.html https://biospectrumindia.com/news/95/5775/agri-experts-remind-government-of-decisive-policy-on-gm.html Fri, 06 Feb 2015 15:02:36 +0530 "It is hysterical situation that even the trials are not being allowed. If government funds a project worth crores and withdraws its approval to product outcome, then it makes no sense in supporting it in first instance" mentioned Dr Deepak Pental former vice chancellor, Delhi University at a roundtable discussion organized by Association of Biotechnology Led Enterprises-Agriculture Group (ABLE-AG) at Delhi on 04 February, 2015. Dr Pental who is also an expert and professor of genetics told BioSpectrum, "It is important to note that 47 percent of Indian population is still dependent on agriculture (small holding farmers). Prosperity of India depends on the prosperity of the Indian farmers. It is calculated that it will still be at 42 percnt by 2032. While it is claimed that enough allocations are made for agriculture, the truth is that 95 percent of funds go into salaries and not in actual research." He feels that activists should also study the effects of pesticide usage and rather pursue other grave health issues such as chewing of tobacco and ghutkha. As per international agri-biotech consultant, Dr Shanthu Shanthram, the complete politicization has happened in India since Jairam put a moratorium on it. Dr Shantharam who is also a visiting professor at the Iowa State University added further, "Policy can't be decided on streets. Although new government has been positive, outcome is yet to be seen. There is what I call 'muti-million protest industry' thriving on the issue. Technology has been held hostage." And there are comparisons with other countries on policy as well. "Canada is an example as it is one country which is never aggressive like US as alleged. But it has got 7.7 million hectares under GM crop cultivation. We either follow Europe or Japan and be among GM importing nations or like Canada develop it keeping our population in consideration. Indians can't afford to be foolish to reject technology where crores of tax payers' money has already been invested to improve agriculture. If there is a solution through conventional breeding let it be! But now decision has to be taken," said a scientist who works with a premier agri institute. The ABLE-AG has urged the government to look into the issues faced by the ari-biotechnology entreprenuers and companies. It has called for a constructive dialogue among stakeholders to resolve differences. ]]> <![CDATA[Pfizer to buy Hospira in a $16 bn deal]]> https://biospectrumindia.com/news/95/5590/pfizer-to-buy-hospira-in-a-16-bn-deal.html https://biospectrumindia.com/news/95/5590/pfizer-to-buy-hospira-in-a-16-bn-deal.html Fri, 06 Feb 2015 12:43:22 +0530 Recently, US-based drug giant Pfizer announced that it would acquire Hospira, an injectable specialist, in a $16 billion deal. The acquisition will make Pfizer a leading player in the emerging markets and help Pfizer to enhance its product portfolio for hospital based injectable drugs and biosmilars. With many of Pfizer's blockbuster drugs losing patent protection, the company needs new products to beef up its portfolio and earnings. Moreover, Hospira has an attractive pipeline of biosimilars, including a biosimilar of Johnson & Johnson's Remicade approved in Europe. Though Hospira has a broad portfolio of generic injectable drugs and biosimilars, the company has been under the regulatory scanner, scrambling to solve the persistent manufacturing issues and quality problems at its facilities. The lure for Pfizer is a global biosimilar market that could soar up to $20 billion in sales in five year. The deal clearly underscores that biosimilars would be the upcoming pharmaceutical revolution. Hospira is currently selling its biosimilars in Europe and Australia, and is seeking approvals to sell the drugs in the US. Acquiring Hospira would turn Pfizer, which has been trying to build up its biosimilars business, into a top player along with Novartis AG . ]]> <![CDATA[Dr Cyrus S Poonawalla: the EY Entreprenuer of the year]]> https://biospectrumindia.com/news/95/4416/dr-cyrus-s-poonawalla-the-ey-entreprenuer-of-the-year.html https://biospectrumindia.com/news/95/4416/dr-cyrus-s-poonawalla-the-ey-entreprenuer-of-the-year.html Fri, 06 Feb 2015 12:28:00 +0530 Dr Cyrus S Poonawalla, chairman and managing director of Serum Institute of India is awarded the EY Entrepreneur of The Year 2014. Serum Institute Of India pioneered the development of affordable life-saving vaccines and is World's No. 1 manufacturer (by volume, more than 1.3 billion doses) of Diphtheria, Tetanus, Pertussis, Hib, BCG, r-Hepatitis B, Measles, Mumps and Rubella vaccines. Dr Cyrus S Poonawalla will now represent India at the EY World Entrepreneur of the Year Award (WEOY) in Monte Carlo from 3-7 June, 2015. BioSpectrum had conferred Person of the Year award to Dr. Cyrus S Poonawalla in 2004. ]]> <![CDATA[Dr Reddy's to expand manufacturing units]]> https://biospectrumindia.com/news/95/4440/dr-reddys-to-expand-manufacturing-units.html https://biospectrumindia.com/news/95/4440/dr-reddys-to-expand-manufacturing-units.html Fri, 06 Feb 2015 11:56:55 +0530 Dr Reddy's Laboratories is set to expand the capacity of three of its bulk drugs and intermediates manufacturing plants located in Telangana, with a combined investment of Rs 82 crore, according to reports. Reportedly, the company has approached the Ministry of Environment and Forests for necessary approvals to expand the combined capacity of three facilities to over 142 tonnes per month from the existing 41 tonnes. This was listed in the minutes of the meeting held last month by the Expert Appraisal Committee (EAC) under MoEF. It proposes to expand the API manufacturing capacity from 21.9 TPM to 68.76 TPM in an area of 16.81 acres (existing 13.27 acres and additional proposed 3.54 acres), EAC said. "We have spent approx Rs 675 crore during the past three quarters in FY15. Full year FY15 plan may be around Rs 1,000 crore or so. FY16 numbers cannot be communicated at the moment," said the DRL official in a statement. According to EAC, the manufacturing capacity for some of the fast moving drugs such as Omeprazole, Atorvastatin, Ciprofloxacin HCL, Fondaparinux Sodium, Metoprolol Succinate, Clopidogrel Bisulphate and Fexofenadine Hydrochloride are set to go up considerably once the expansion takes place. ]]> <![CDATA[AstraZeneca to buy Actavis' respiratory business]]> https://biospectrumindia.com/news/95/4392/astrazeneca-to-buy-actavis-respiratory-business.html https://biospectrumindia.com/news/95/4392/astrazeneca-to-buy-actavis-respiratory-business.html Fri, 06 Feb 2015 11:36:06 +0530 AstraZeneca (AZ) and Actavis have announced that they have entered into a definitive agreement. As per the agreement, AstraZeneca will acquire the rights to Actavis' branded respiratory business in the US and Canada for an initial consideration of $600 million on completion and low single-digit royalties above a certain revenue threshold. Upon completion of the transaction, AZ will own the development and commercial rights in the US and Canada to Tudorza Pressair (aclidinium bromide inhalation powder), a twice-daily long-acting muscarinic antagonist (LAMA) for chronic obstructive pulmonary disease (COPD), and Daliresp (roflumilast), the only once-daily oral PDE4 inhibitor currently on the market for COPD. AZ will also own development rights in the US and Canada for LAS40464, the combination of a fixed dose of aclidinium with formoterol long acting beta agonist (LAMA/LABA) in a dry powder inhaler, which is approved in the EU under the brand name Duaklir Genuair. The acquisition of Tudorza Pressair and Daliresp will immediately add on-market revenues and complements AstraZeneca's respiratory portfolio by broadening the choice of treatments and formulations offered to patients and physicians. The two products had combined annual sales in the US of approximately $230 million in 2014. Mr Paul Hudson, president, AstraZeneca US and executive vice-president, North America, said, "Our agreement with Actavis builds on our acquisition of Almirall's respiratory portfolio and brings long-term value to one of our key growth platforms. With the addition of Tudorza and Daliresp, we will benefit from an immediate boost to revenue in our biggest market, further strengthening our growing respiratory franchise. This combined portfolio helps us to offer an even broader range of innovative treatments and formulations to physicians and pulmonary specialists for patients suffering with COPD." The transaction is subject to anti-trust law clearance as well as other customary terms and conditions. It is anticipated that the transaction will complete in the first quarter of 2015. ]]> <![CDATA[Aurobindo to join hands with Tergene]]> https://biospectrumindia.com/news/95/7156/aurobindo-to-join-hands-with-tergene.html https://biospectrumindia.com/news/95/7156/aurobindo-to-join-hands-with-tergene.html Fri, 06 Feb 2015 11:22:00 +0530 Aurobindo Pharma will form a joint venture (JV) with the Hyderabad-based Tergene Biotech for developing pneumococcal conjugate vaccine (PCV). "The Board of Directors has approved the proposal for setting up a joint venture with Tergene Biotech" said Aurobindo Pharma in a BSE filing. Tergene is currently working on development of the PCV through use of novel vaccine technology compressing time and cost, thereby making such vaccine available at an affordable cost. Aurobindo will hold a majority stake in the JV and will fund the product development in a phased manner spanning over three years. The financial terms are subject to entering into definitive agreements. ]]> <![CDATA[AstraZeneca gifts its Quebec & UK centers]]> https://biospectrumindia.com/views/95/4743/astrazeneca-gifts-its-quebec-uk-centers.html https://biospectrumindia.com/views/95/4743/astrazeneca-gifts-its-quebec-uk-centers.html Fri, 06 Feb 2015 09:59:00 +0530 With some deft manoeuvers, the facility was salvaged and entrusted to NeoMed Institute, set up specially to run the research center. NeoMed is a public-private partnership venture. AstraZeneca contributed a bulk of the $100 million investment in the center by providing the lab facility as it is and further sanctioning $3 million. Pfizer which has a research center nearby was also "persuaded" by the Quebec government to contribute more than $2 million to the cause. NeoMed is now a thriving bioincubator and has hired back more than 50 of the retrenched scientists in the last two years."I do hope AstraZeneca can emulate their generosity shown to the government of Quebec in Montreal, Canada, where it donated the Neuroscience Research Centre and IP to create the NEOMED Institute for Neuroscience. A similar gesture in Bangalore can help to create the Brain Research Institute with Indian Institute of Science, or even create a biopharma incubator with the available infrastructure. It will also create a goodwill by dispelling the impression that MNCs are not committed to India. It will be a shame to destroy such valuable research infrastructure and sell it to real estate developers," elucidated Dr Mazumdar-Shaw, Biocon's chief and chair of Karnataka government's Vision Group on Biotechnology.In another recently related development, AstraZeneca on March 11, 2014 announced the sale of its Alderley Park site in Cheshire, UK, to Manchester Science Parks (MSP), a Greater Manchester based public-private partnership and science park operator. This move, according to the company, is an endeavor to establish a new global R&D center and corporate headquarters in Cambridge, UK, by 2016.There are many more such examples of Big Pharma companies helping the local research communities even after their exits in other parts of the world.Considering the invaluable contribution of an advanced research center like Avishkar in nurturing young companies and budding scientists, in the back drop of declining quality of research in India, the government of Karnataka should probably take advantage of this opportunity to prevail upon AstraZeneca in order to salvage its R&D center and use it to strengthen research at all possible capacities. ]]> <![CDATA[Union Health Minister releases 10th edition of API Textbook of Medicine]]> https://biospectrumindia.com/news/95/7740/union-health-minister-releases-10th-edition-of-api-textbook-of-medicine.html https://biospectrumindia.com/news/95/7740/union-health-minister-releases-10th-edition-of-api-textbook-of-medicine.html Thu, 05 Feb 2015 15:25:52 +0530 The 10th Edition of API (Association of Physicians of India) Textbook of Medicine was released by Shri Jagat Prakash Nadda, Hon'ble Union Minister of Health & Family Welfare at an event in New Delhi. Mr. Nadda, the Chief Guest for the event, also presented prestigious Dr Jivraj Mehta Awards for the year to eminent physicians of the country. Dr Shashank Joshi, president API; Dr Rajesh Upadhyay, president Elect API and Dr YP Munjal, Editor-in-Chief of the 9th and 10th Edition of API Textbook of Medicine addressed the conference. Other dignitaries present at the ceremony included Dr Milind Y Nadkar, Hon'ble secretary, API and Dr Pritam Gupta, Dean ICP. The event also witnessed the release of electronic version of 10th Edition of API Textbook of Medicine by Dr Jitendra Singh, Hon'ble Minister of State, PMO & DOPT and Guest of Honour for the event. The book will see major issues discussed, such as the gaps that exist in healthcare implementation, understanding of disease and its management, the disease profile and substantial change along the demography of various disorders. For the first time 'Futuristic Medicine' and the problems of 'Space Travel' have been delineated and highlighted through the book. This part of the book deals with the anticipated progress in medicine which will be put to clinical use in the coming one to two decades or the advances that are being used in their early stages in clinical practice. The book intensively describes Futuristic Medicine, Regenerative Medicine, Introduction to Space Medicine, Nanotechnology and Nanomedicine and Robotic Surgery. The book also discusses 'Disease Profile and Epidemiology of Communicable and Non-communicable Diseases in India' that gives an ample understanding of the diseases commonly prevalent in this part of the world. The parts of the book also deal with various life-style disorders like diabetes mellitus and cardiovascular diseases. The eminent physicians who were felicitated with Dr Jivraj Mehta Award during the event were Dr Ashok Das, Dr V Mohan, Dr Dev Pahlajani, Dr V Parameshwara, Dr GS Sainani and Dr SK Sharma. Speaking on the occasion, Dr Shashank Joshi, President API said, "It is indeed a proud moment for the Association of Physicians to come out with the Textbook's 10th edition. The textbook is a result of constant hard work and dedicated efforts of all the members of the Association. I congratulate the API and specially Dr Y P Munjal, for keeping up this work. I would also like to congratulate the winners of the prestigious Dr Jivraj Mehta Awards for the year for their outstanding contributions to the medicine world." ]]> <![CDATA[BP Sharma takes over as new health secretary ]]> https://biospectrumindia.com/news/95/8294/bp-sharma-takes-over-as-new-health-secretary-.html https://biospectrumindia.com/news/95/8294/bp-sharma-takes-over-as-new-health-secretary-.html Thu, 05 Feb 2015 11:32:14 +0530 In a recent bureaucratic reshuffle by the Modi government on February 01, 2015, the senior IAS officer, Mr Bhanu Pratap Sharma has been appointed as health secretary in the Ministry of Health and Family Welfare. Mr Sharma, a 1981 batch IAS officer of Bihar cadre, is at present establishment officer and special secretary in the Department of Personnel and Training (DoPT). His predecessor, Mr Lov Verma, a 1978 batch IAS officer of Uttar Pradesh cadre has been given the responsibility of Department of Empowerment of Persons with Disabilities as a secretary. It is important to note that he has only one year left to his retirement. He had recently expressed his desire to achieve 'Immunization Mission 2020' health goals during an event 'PEDICON' event by the Indian Academy of Pediatrics. His transfer is apparently being taken as a step towards replacement of bureaucrats appointed by the previous regime. New health secretary reviews swine flu situation Recently on February 03, Mr B P Sharma reviewed preparedness of the states affected with H1N1 to manage the situation, here today. Mr Sharma held a video conference meeting with senior health officials of states of Telangana, Kerala, Maharashtra, Gujarat, Rajasthan, West Bengal and Uttar Pradesh, and with officials of government of Delhi. As per the minister, "Situation was reviewed in terms of the adequacy of medicines and personal protective equipment such as masks with the state health departments, along with number of adequately equipped and functioning isolation wards. The review also included the training provided to the doctors, rapid response teams and para-medical staff at various district and other government hospitals, in addition to the IEC campaigns mounted to create awareness among the masses regarding the preventive steps to be taken." The health ministry had advised the states to ensure that all necessary steps be taken to prevent increase in number of casualty by informing the people to approach the public health facilities in time for effective treatment, and to educate them on ways to prevent it. The union government is closely monitoring the situation in the states and has assured them all assistance in terms of medicine, testing kits, personal protective equipment etc. Central teams have been sent to Telangana, Rajasthan and Gujarat to assess the situation and help them to manage the cases. ]]> <![CDATA[Only inhalable insulin hits US market]]> https://biospectrumindia.com/news/95/5216/only-inhalable-insulin-hits-us-market.html https://biospectrumindia.com/news/95/5216/only-inhalable-insulin-hits-us-market.html Thu, 05 Feb 2015 11:31:37 +0530 The candidate had been approved by the US Food and Drug Administration (USFDA) to control high blood sugar in adults with type 1 and type 2 diabetes. Afrezza is a drug-device combination product that consists of a dry formulation of human insulin delivered from a small and portable inhaler to help patients achieve blood sugar control. "Many people living with diabetes are not able to control their blood sugar on their current medications and may benefit from using insulin. Now they have another option to administer insulin that is not an injection," said Dr Janet McGill, Professor of Medicine at Washington University School of Medicine in St Louis and Afrezza clinical trial investigator. "This delivery option may help change the dialogue between health care professionals and people living with diabetes about initiating or intensifying insulin therapy." Afrezza is rapidly absorbed and has a short duration of action. It is administered at the beginning of a meal. "Afrezza is an important addition to Sanofi's growing diabetes portfolio of integrated, personalized offerings, and it is one that highlights our dedication to bringing innovative therapies to people with this disease," said Mr Pierre Chancel, senior VP, diabetes division, Sanofi. "There is a recognized need for an insulin that doesn't require an injection, and our organization is committed to making this new treatment option available to patients." It can help control high blood sugar as part of a diabetes management plan that may include diet, exercise and other diabetes medications. The powder should not be used in patients with chronic lung disease such as asthma or COPD. It cannot be used to treat diabetic ketoacidosis. Also, it is not recommended in patients who smoke or who have recently stopped smoking. "We are extremely proud to see the many years of work that went into developing Afrezza culminate in the day when it is now available to help people manage their diabetes," stated Mr Alfred Mann, executive chairman, MannKind Corporation. ]]> <![CDATA[US FDA approves Pfizer's breast cancer drug]]> https://biospectrumindia.com/news/95/5215/us-fda-approves-pfizers-breast-cancer-drug.html https://biospectrumindia.com/news/95/5215/us-fda-approves-pfizers-breast-cancer-drug.html Thu, 05 Feb 2015 11:30:48 +0530 Pfizer has announced that the US Food and Drug Administration (US FDA) has granted accelerated approval of IBRANCE (palbociclib), in combination with letrozole, for the treatment of postmenopausal women with estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) advanced breast cancer, as initial endocrine-based therapy for their metastatic disease. This indication is approved under accelerated approval based on progression-free survival (PFS). Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. The confirmatory Phase III trial, PALOMA-2, is fully enrolled. IBRANCE was reviewed and approved under the FDA's Breakthrough Therapy designation and Priority Review programs. The IBRANCE new drug application was based on the final results of the Phase 2 PALOMA-1 trial. The most frequently reported adverse event for IBRANCE plus letrozole in PALOMA-1 was neutropenia. "I am proud of the clinical program for IBRANCE, which was discovered in Pfizer laboratories, and the innovation we are able to bring forward to the breast cancer community. The registration trial showed that, compared to letrozole alone for first-line treatment of ER+/HER2- advanced breast cancer, IBRANCE in combination with letrozole almost doubled the time before tumor progression,1 delaying the need for later-line therapies including other hormonal agents and chemotherapies." said Mr Ian Read, chairman and CEO, Pfizer. "FDA approval of IBRANCE marks a pivotal milestone that demonstrates the strength of our science, provides an important medicine to patients in need, and underscores the contributions our Company can make to society," he added. ]]> <![CDATA[Life, as the curtains go down at AstraZeneca R&D Bangalore]]> https://biospectrumindia.com/features/95/6614/life-as-the-curtains-go-down-at-astrazeneca-rd-bangalore.html https://biospectrumindia.com/features/95/6614/life-as-the-curtains-go-down-at-astrazeneca-rd-bangalore.html Thu, 05 Feb 2015 09:54:00 +0530 The state-of-art center was the showpiece of Bangalore and was instrumental in placing India in the global biotech map. The center, when closed has added a wealth of trained scientists to the Indian pool of researchers. For Dr Vasanthi Ramachandran, it was just any other Monday. She woke up early morning and hurriedly finished the household chores. In no time, the breakfast was ready. The clock ticked 8.30 and Dr Ramachandran knew she was late! She hurried into the room, wore a nice red and golden cotton sari, carefully put a bindi on her forehead, tied her hair and off she left for work. As she paced towards her car, a plethora of thoughts were running in her mind. Her three decades career at AstraZeneca had shaped her into a strong team leader, with expertise in handling most contagious pathogens and solving challenges in drug discovery processes. She was thinking about the unfinished tasks for that day and issues to address posed by her team from the previous evening. The company's research projects were very well poised at that juncture, with a lot more interesting work to be done in the coming months, thereby bringing them a step closer to their ultimate goal of discovering novel and safe medicines for neglected diseases. As these thoughts rushed in her mind, the ever so familiar gates of the state-of-art AstraZeneca research center appeared; Dr Ramachandran got down and quickly walked inside after swiping her ID card at the entrance.Morning greetings followed. Dr Ramachandran acknowledged her colleagues and team with a smile. They smiled back. She quickly put her handbag away and marched excitedly towards the meeting room to discuss the day's agenda and previous day's results with her team. The team happily shared the new positive outcome of the test they had incubated. Dr Ramachandran's joy knew no bounds! She acknowledged their hard work and immediately rushed to the manager's cabin to convey the news. The manager was busy checking his mails. The usual smile on his face was missing. Dr Ramachandran greeted him, and sat on the chair. With complete enthusiasm she explained the achievement made by her team. Still this encouraging news too failed to bring a smile on to his face. 'Good' was the only answer she received. A little dejected, Dr Ramachandran returned to her desk. Her colleague, Dr Sunita de Sousa was passing by. She greeted Dr Ramachandran and asked her how her weekend was. But Dr Ramachandran was in no mood to discuss. In a confused tone, she told De Sousa, "I feel something bad is about to happen today." "You appear a little disturbed, nothing will happen," comforted, Dr DeSousa. With around 75 researchers, AstraZeneca R&D center for TB and malaria research, was more of a family than a workplace. For Dr Ramachandran and Dr De Sousa, who was the associate director and manager of external collaborations, AstraZeneca was much more than a research lab. It was their second home, where they had spent close to three decades of their life playing with microbes, carrying out innovative research with an intention to solve the healthcare woes of India and the world. The swanky research center was a show-piece of Bangalore and also had the AstraZeneca Pharmaceutical Development lab housed in the same campus, which employed around 100 scientists. The R&D center was focused on developing drugs for neglected tropical diseases. In the last three years, AstraZeneca had published several research articles in top journals, thus speaking about the quality and credibility of the innovative research carried at the facility.Soon, it was tea break. The team gathered together in groups for tea. Suddenly the quiet workplace seemed very jovial. The clutter of tea glasses, the gossips, the chatters all filled the atmosphere with complete cheer. Young interns at the center were busy discussing Bollywood movies, the senior team members also joined in the fun. It seemed a perfect setting for an early morning break. Suddenly one person announced that there was an urgent email summoning all of them to a compulsory meeting in the auditorium. All employees rushed to the auditorium curious about what this early morning meeting could be! As the employees gazed towards the podium a foreign official arrived on the dais. The official, who identified himself as a member of AstraZeneca's global senior management team, announced with a solemn voice, "With great difficulty, I am announcing that AstraZeneca is planning to shut its Bangalore R&D center."A silent wave swept through the room. The employees looked at each other in a state of dismay and disbelief! Many sat on their chair, unable to trust what they just heard. 'Why us' was the major question in Dr Ramachandran's mind. Back in 1986 when she came to Bangalore post marriage, Astra had welcomed her with open arms. At this very center she had completed her PhD, through IISc, Bangalore. The center was more than a workplace to her. "What will I do next?" she said, confusion and sadness clear in her voice. "I would have loved to continue working for a few more years."Soon, the fun-filled atmosphere of the room was suddenly filled with tears, anxiety and grief. Few of them said that the decision was probably not true and it would change. "The center had established a strong foothold in research! Why will they want to close it?" they argued in a worried tone. But they somehow knew that their argument was futile. For many employees who were sustaining families, school fees, monthly EMI, their bills flashed in front of their eyes. "What will I tell my people back home," said an employee, "that I was given a pink slip! How will I meet my mother's treatment costs?"Dr De Sousa and Dr Ramachandran were very upset. More than anything the two were worried about the eminent research carried out at the facility and the beautiful memories associated with the place. "We started and built our career here," Dr De Sousa said to Dr Ramachandran in a depressed tone. "What will happen to the new molecule we have discovered for treatment of malaria?" Dr Ramachandran's team members gathered around her. In a worried tone a girl asked her, "What will I do next? This is such a unique center. Will I be able to find something similar?"ClosureThe company had decided its strategic focus areas and clearly this Bangalore R&D center was not its priority. Dr Vasan Sambandamurthy, team leader, who had worked at the AstraZeneca Pharma R&D center for six years, said, "There were several reasons that could have led to the shut down-to cut down operating costs and reduce headcount; lack of commercial potential for drugs to treat diseases of the developing world; research culture within India not being conducive and sustainable in the long run among many"The announcement was made in January and time was given till April to exit the site. According to the employees' statements, AstraZeneca did a marvelous job of helping employees with the transition, by hiring an HR company, to help employees with writing resumes, interview skills, training for alternative careers and trawling job opportunities depending on what each individual was looking for. The local management was very supportive in placing people through their contacts. Many people have said to have found appropriate replacements. Though initial confusion and brooding happened for a few, many others looked at this as a welcome opportunity to explore new avenues and challenges. A few had to make compromises with the new job, others had to relocate. Many scientists used this notice period granted as an opportunity to publish the research done and improve their CVs. Later, with all the support the company offered for the transition, it left most people in a comfortable space and there were practically no bitter feelings.Dr Sambandamurthy, who was also impacted by the shutdown said, "The news of closure came as a shock to all of us. That day was probably a day I would never forget. Every colleague with whom I was associated with during the blissful six years at AstraZeneca, had the somber expression of 'what next'." Having worked abroad, this situation was not particularly unfamiliar to me, however going through the process was not a welcome feeling. No doubt, the company's departure represents a "tremendous loss", and painful experience, but for many of us it was also an opportunity to explore newer research avenues and broaden our skill sets and knowledge base.""Many of the research work carried at the center was in collaboration and has been continued by the partners," said Dr De Sousa. "The tests for the malaria molecule which was pending, was continued at the UK AstraZeneca site. Recently Medicines for Malaria Venture supported the selection of this molecule as a candidate drug for development (AZD13721412 (MMV674253).""It would have been great if the AstraZeneca infrastructure at Bangalore could have been taken over by institutions involved in drug discovery best exemplified when Piramal took over the CIBA facility in Mumbai when CIBA closed. Such an infrastructure takes years to build and sustain, it being dismantled is indeed a sad event in the history of research on neglected diseases in the India context," said Dr TS Balaganesh, former head AstraZeneca R&D center.With increase in R&D spending and decline in success rates for clinical trials, research and development in India is becoming tough. The closure of the center, would certainly have an impact on the quality of research as well on the quality of scientific human resource. Moreover, start-ups will be deprived of valuable technical support and incubation facilities, which no other R&D center has encouraged. "Our work in AstraZeneca was a contribution to the scientific community. There was no money in it, concluded Dr Ramachandran, "however we were discovering molecules that had the potential to become wonder drugs in future. I fervently hope that the efforts to bring out newer and safer drugs for the neglected diseases like malaria and TB which basically affect the millions living in 3rd world countries will be pursued in earnest elsewhere. It will be great if another facility like AstraZeneca comes up in India." ]]> <![CDATA[NATHEALTH appoints a new President]]> https://biospectrumindia.com/news/95/6584/nathealth-appoints-a-new-president.html https://biospectrumindia.com/news/95/6584/nathealth-appoints-a-new-president.html Wed, 04 Feb 2015 13:05:00 +0530 NATHEALTH, elected Johnson & Johnson Medical India's managing director (MD) Mr Sushobhan Dasgupta as president for one year. He took over from Fortis Healthcare executive vice-president Mr Shivinder Mohan Singh. "One of the major challenges facing India today is providing affordable healthcare to millions of unserved and underserved patients. We are committed to work towards reaching our goal of providing accessible and affordable healthcare for everyone," said Mr Dasgupta. He also said that activities and initiatives of the NATHEALTH will be in line with its six mission pillars as enabling the environment to fund long-term growth, help develop and optimise healthcare infrastructure, help shape policy and regulations, help bridge the skill and capacity gap, encourage innovation and support best practices and promote accreditation. Max India MD and Max Healthcare Institute head Mr Rahul Khosla and Philips India vice-chairman Mr A Krishna Kumar were elected as senior vice-president and vice-president of the body respectively. Other office bearers of the newly elected body are Mr Suyash Borar, CEO, Calcutta Medical Research Institute and Mr Preetha Reddy, executive vice-chairperson, Apollo Hospitals Group who were elected as secretary and treasurer respectively. ]]> <![CDATA['Biotech sector to grow to $100 billion by 2025']]> https://biospectrumindia.com/news/95/4163/biotech-sector-to-grow-to-100-billion-by-2025.html https://biospectrumindia.com/news/95/4163/biotech-sector-to-grow-to-100-billion-by-2025.html Wed, 04 Feb 2015 12:56:43 +0530 The Indian biotechnology sector is expected to grow from the current $5-7 billion to $100 billion by 2025. This would double the growth rate of this sector from 15 to 30 percent, according to the Association of Biotechnology Led Enterprises (ABLE). A roadmap on this was presented to Dr Jitendra Singh (Union Minister of State in the PMO) by Dr Kiran Mazumdar-Shaw, president of ABLE, and CMD Biocon. The memorandum submitted by ABLE made several recommendations to support the biotechnology industry. These include deduction of current tax incentives of 200 percent to be increased to 300 percent with a validity of three years and extension of 10 years of tax holiday for biotech/farming establishments by another two years. Invoking the "Make in India" agenda of the present government, the memorandum also pleads for the indigenously made products to be given 15 percent to 25 percent weighted advantage over imported products in all government tenders. "Biotechnology is the science of future and industry's participation in future biotech ventures will also help in expanding the range of its utility as a means of social transformation. The government is keen to promote all kinds of upward activities in Biotech sector and the suggestions offered by ABLE would be given due consideration and dealt with a positive approach." Dr Singh agreed that the key States of India where biotechnology is likely to grow in the near future are Karnataka, Telangana, Andhra Pradesh, and Gujarat but suggested that a focused planning is required to spread it to other states as well because this will not only add to the current growth rate but will also help create new avenues of employment particularly skilled jobs. ]]> <![CDATA[How India lost an iconic biotech lab]]> https://biospectrumindia.com/views/95/5355/how-india-lost-an-iconic-biotech-lab.html https://biospectrumindia.com/views/95/5355/how-india-lost-an-iconic-biotech-lab.html Wed, 04 Feb 2015 09:46:00 +0530 This has ironically happened under the tenure of the state government of Karnataka ruled by the Indian National Congress (INC), which has played a major role in the development of biotech in the state with the launch of biotech millennium policy as early as in 2000-01 during INC's term of office under the then Chief Minister Mr S M Krishna. AstraZeneca was one of the core members of the Vision Group on Biotechnology and the Karnataka Biotechnology Development Council then and a key constituent in the lifesciences sector. It has been a year since the announcement was made and BioSpectrum has pursued this development actively and presents various aspects of the development so far in this cover section. Last January, when AstraZeneca announced that it will close its R&D site in Bangalore, Avishkar, it was a major blow for the industry, R&D, and the employees. The site which had over 165 researchers and was one of the important centers for AstraZeneca was also one of the pioneering corporate R&D set-up and the biosciences anchor. It was focused on pharmaceutical development and drug discovery research in neglected tropical disease, tuberculosis (TB), and malaria for almost three decades. This development was all the more shocking considering the fact that the R&D center, which had state-of-the-art facilities and equipment dedicated to cutting edge research in the lifesciences, was sold reportedly to leading IT major Cognizant.The center should have been saved but both the state government and the central government failed to persuade AstraZeneca to gift the facilities like what it did with its Quebec and Chesire sites. None from the government is willing to explain the efforts made to persuade AstraZeneca and give an update on the closure of the facility and its present status. Neither is Cognizant willing to comment on the development. They would share the information at the appropriate time is what the Cognizant spokesperson had to say.The facility could have been given to the Center for Brain Research at the Indian Institute of Science or help build a Bioincubator. When asked to share his insights on the entire issue, Infosys co-founder Kris Gopalakrishnan, who has donated $1.8 million to Carnegie Mellon University (CMU) for a research partnership between CMU and the Centre for Brain Research (CBR) at the Indian Institute of Science (IISc) in Bangalore, said, "I have neither approached AstraZeneca nor did I bid. The only thing I know is that IISc wanted to buy AstraZeneca facility to establish a center for brain research. I came to know that IISc approached AstraZeneca and at that time AstraZeneca had an offer from some others. AstraZeneca informed us of the same and we left it there." If only AstraZeneca followed some of the successful models of gifting the facilities that it did elsewhere in the world, it would have been a great boon for the industry. Hope Cognizant makes it up and develops this facility as a center of excellence.It maybe recalled that AstraZeneca was formed by the merger of Sweden-based Astra and UK-based Zeneca in 1999. Headquartered in London, it is the world's seventh largest company and has operations in over 100 countries. Astra AB was formed in 1913 by 400 doctors and apothecaries. AstraZeneca Pharma India Limited was incorporated on July 11, 1979 under the name of Astra IDL Limited. In 1984 Astra AB set up the Bangalore site as a non-profit organization engaged in the promotion of biomedical research and sponsorship of symposia in infectious disease in India. (The symposium part was not a part of the remit until 1996). In February 2001, AstraZeneca announced it had completed a transaction to buy a controlling stake in the joint venture company Astra-IDL, and renamed it as AstraZeneca Pharma India Ltd. Based in Bangalore, AstraZeneca Pharma India Ltd manufactures and distributes AstraZeneca products.The Astra Research Center was commissioned some time in 1985 which was later named the AstraZeneca R&D Center following the merger of Astra and Zeneca. The research center was initially started as a small facility inside the IISc campus and then moved to Aranya Bhavan in Malleswaram, Bangalore. This facility was inaugurated by the then Prime Minister Mr Rajiv Gandhi and was conducting research on neglected tropical diseases, diarrheal diseases, malaria, and tuberculosis. Due to its excellent performance, in order to improve the lab facilities and to provide a better environment for research, the company moved it around 10 years ago to Kirloskar Business Park at Hebbal. The research center that began with close to 8 scientists soon beefed up to a strength of 75 in AstraZeneca R&D and around 100 in pharmaceutical development R&D which was also located in the same campus. This new location gave the R&D center easy access to academic hubs of excellence including National Center for Biological Sciences (NCBS), Jawaharlal Nehru Centre for Advanced Scientific Research (JNCASR) and the Indian Institute of Science (IISc), University of Agricultural Sciences (UAS), Center for Cellular and Molecular Platforms (C-CAMP), and Indian Veterinary Research Institute (IVRI).The lab was fully integrated with AstraZeneca's global R&D infrastructure and had state-of-art facilities. The unit was unique in being the only or one of very few places in India doing innovative drug discovery and one focused on diseases of the developing world such as TB and malaria. There was a focus on high quality science, good laboratory standards and on safety and ethical practices as well. Many organizations like Global Alliance for Tuberculosis, Welcome Trust, and Medicines for Malaria Venture, European Union had funded the research work carried at the facility. The center provided the complete ecosystem for a perfect R&D. Many youngsters joined this center as trainees and the facility also conducted summer workshops to train young talent and generate skilled workforce for the country. The AstraZeneca center was a training ground for India's budding entrepreneurs. More than half-a-dozen biotech companies have been set up by scientists who learnt the rigors of corporate R&D under the watchful eyes of AstraZeneca research heads. AstraZeneca PLC announced a major investment program in 2001 that included $10 million to create new research laboratories in Bangalore, and $5 million in 2001 to support research activities. This was significant considering the fact that the investment in India was to create a center of excellence at its facility in Bangalore for the discovery and development of new medicines of importance to the developing world. The research center, thereafter recruit additional world class scientists, focused majorly on finding a new treatment for tuberculosis. The Executive Director, R&D, at AstraZeneca at that time, Mr Claes Wilhelmsson, then said, "These new laboratories will form an integral part of our research into infectious diseases and, together with academic collaborations, AstraZeneca in Bangalore will become a leading center of excellence for TB research." And Dr Barry Furr, Chief Scientist and Head of the Project Evaluation Group at AstraZeneca then, was appointed to lead the laboratory which housed about 65 scientists. Dr Tanjore Balganesh was the Head of Research at the Bangalore laboratory then, said, "Bangalore is the academic center of India and we are very excited to have this opportunity to attract top class scientists to work with us on this program."Everything seemed to be perfect! However, there was a twist. By early 2013, many of AstraZeneca's blockbuster drugs went off the patent. The list included AstraZeneca's Arimidex, Atacand, Crestor, Nexium and Seroquel IR in a number of markets accounting for a revenue decline of around $2.2 billion. Revenue from Seroquel slipped 31 percent to $438 million while blood pressure drug Atacand's sales decreased 37 percent to $166 million, Bloomberg reported."As expected, our financial performance in 2013 reflected the ongoing impact of the loss of exclusivity for several key brands, with revenue down 6 percent to $25,711 million, said Mr Leif Johansson, Chairman, AstraZeneca, in a statement. "The industry faces an ongoing R&D productivity challenge. R&D costs have risen significantly over the past decade, while industry-wide probability of success of new medicines, though showing some recent signs of improvement, has not kept pace." The Forbes magazine reported that from 1997-2011 AstraZeneca spent close to $58,955 million on R&D and could manage to get only 5 drugs approved in that period. "AstraZeneca continues to be hit heavily by its patent cliff," said Mr Mick Cooper, an analyst at Edison Investment Research in London. The company then initiated workforce optimization and business alignments and began the closure of its R&D sites, the first to be hit was the Alderley Park in England sacking/relocating nearly 2900 jobs. As per its corporate restructuring plans the company announced in its annual report that it planned to reduce the headcount at global AstraZeneca sites thus afflicting many employees."The restructuring program is expected to deliver a further $300 million in annual benefits by the end of 2016, bringing total anticipated annualized benefits of the program to $1.1 billion. The expansion of the program is estimated to affect approximately 550 positions, bringing the total global headcount reduction under the program to around 5,600 over the 2013-2016 period," said the company in its annual report. The company also announced its three major target areas - Respiratory, Inflammation & Autoimmunity; Cardiovascular & Metabolic Disease and Oncology. It clearly said that the focus on infection and vaccines and neuroscience will be opportunity driven. The company plans to align around three strategic R&D sites and two satellite labs. The beginning of 2014 saw a new development. US-based Pfizer showed its interest in acquiring AstraZeneca for $100 billion. However, the British drug maker rejected the offer. The takeover would have made Pfizer-the world's biggest drug maker. Since then, to overcome the losses for its patented products AstraZeneca has made a series of acquisitions to strengthen its product portfolio. In December 2013, AstraZeneca announced an agreement to purchase BMS's 50% interest in AstraZeneca-BMS joint diabetes business. This acquisition completed in February 2014. Under the agreement, approximately 3,900 BMS and Amylin employees will transfer to AstraZeneca. Employees affected by the changes in India left the company at the end of April and the site has been closed. Several of the employees are understood to have joined Biocon. AstraZeneca's India commercial organization and the clinical operations, also based at the Avishkar site, moved to Manyata Tech Park in Bangalore. ]]> <![CDATA[Mylan to Acquire Famy Care for $800 Mn]]> https://biospectrumindia.com/news/95/5050/mylan-to-acquire-famy-care-for-800-mn.html https://biospectrumindia.com/news/95/5050/mylan-to-acquire-famy-care-for-800-mn.html Wed, 04 Feb 2015 09:30:00 +0530 Mylan announced that it has, through its Indian subsidiary Mylan Laboratories, signed a definitive agreement to acquire certain female health care businesses from Famy Care Limited, a specialty women's health care company with global leadership in generic oral contraceptive products (OCPs) for $750 million in cash plus additional contingent payments of up to $50 million. Famy Care, headquartered in Mumbai, India, offers a comprehensive range of women's health products including oral and injectable contraceptives, intra-uterine devices (IUDs), tubal rings and hormonereplacement therapy products. The acquisition will build on Mylan's existing partnerships with Famy Care in North America, Europe and Australia, and provide Mylan with an enhanced and now vertically integrated platform that will accelerate the company's growth in the important global women's health care space. This transaction especially complements Mylan's pending acquisition of Abbott's non-US developed markets specialty and branded generics business, which also includes a women's health care portfolio and sales and marketing capabilities. Additionally, the acquisition of the Famy Care businesses will make Mylan a hormonal contraceptives leader in high-growth emerging markets around the world. Mylan's CEO Ms Heather Bresch commented, "In 2008, Mylan established a partnership with Famy Care, significantly enhancing its presence in the women's health care segment in the US and other developed country markets. With today's acquisition, we are building on this successful partnership and further accelerating our global growth in this important therapeutic area. We see many opportunities to tap the large women's health care market in Europe, particularly through our pending Abbott deal; the prospect of driving additional value from this business in North America; and exciting growth potential in emerging markets. Finally, we are excited to welcome Famy Care's more than 900 employees to the Mylan family and look forward to their contributions to our mission of providing the world's 7 billion people access to high quality medicine." The acquisition is expected to be immediately accretive to Mylan's adjusted diluted earnings per share and growth profile upon closing. Mylan's president Mr Rajiv Malik added, "By adding this vertically integrated business and globalizing our women's health care platform, we are creating the right foundation to become a leader in this growing, attractive sector. Famy Care brings us a broad portfolio, strong technical capabilities and dedicated hormone manufacturing, which complement Mylan's powerful global commercial footprint and supply chain infrastructure. In addition to the opportunities we see in North America and Europe, Famy Care's businesses will strengthen our position in emerging markets, where we can build upon and leverage our existing capabilities, including the strong presence we have established through our antiretroviral business and our track record of success in competing for tenders in these markets. Finally, we see opportunities for generating more front-end sales, in addition to Famy Care's successful partnering strategy, as a result of our exceptional global infrastructure." The transaction is expected to close in the second half of 2015, subject to regulatory approvals and certain closing conditions. Commenting on the transaction, J P Taparia, non-executive chairman of Famy Care, said, "This transaction represents a significant milestone for Famy Care and its employees, who have created a world-class women's health care franchise. We foresee significant opportunities in the women's health care business across developed and emerging markets, and the proposed transaction provides an opportunity for our team to capture the opportunity in an even more effective manner." ]]> <![CDATA[Lupin's diarrhoea drug gets US FDA nod]]> https://biospectrumindia.com/news/95/4094/lupins-diarrhoea-drug-gets-us-fda-nod.html https://biospectrumindia.com/news/95/4094/lupins-diarrhoea-drug-gets-us-fda-nod.html Tue, 03 Feb 2015 12:34:34 +0530 Lupin Pharma has announced that the US Food and Drugs Administration (US FDA) has approved its Vancocin capsules. Lupin's vancomycin capsules are the AB rated generic equivalent of ANI Pharmaceuticals Vancocin capsules and are indicated for the treatment of C. difficile-associated diarrhoea and also for the treatment of enterocolitis caused by staphylococcus aureus (including methicillin-resistant strains). The company's US subsidiary, would commence marketing the product shortly. The company has received final approval for its Vancomycin Hydrochloride Capsules in strengths of 125 mg and 250 mg. According to IMS MAT September, 2014, Vancocin capsules had annual sales of $164.2 million in the US. ]]> <![CDATA[Swine flu cases go up, govt sets up monitoring cell]]> https://biospectrumindia.com/news/95/5464/swine-flu-cases-go-up-govt-sets-up-monitoring-cell.html https://biospectrumindia.com/news/95/5464/swine-flu-cases-go-up-govt-sets-up-monitoring-cell.html Tue, 03 Feb 2015 12:05:35 +0530 The first month of this year has already witnessed 191 deaths from swine flu. At the same time, the total number of cases reported in January stood at 2,038. According to the health ministry data, Rajasthan tops the chart with 49 death cases out of reported 205 cases followed by Gujarat where 309 persons contracted swine flu with the virus claiming 38 lives while Telangana recorded 629 cases with 34 deaths. 73 cases have been noted in Maharasthra with 22 deaths. Tamil Nadu witnessed 93 cases with seven lives claimed by the disease while Madhya Pradesh and Haryana reported 49 and 57 cases with the death toll in these states standing at 17 and eight, respectively. Andhra Pradesh reported 33 cases, leading to four deaths. Union govt responds but blames states for mess Reiterating that the present spurt is seasonal, the Minister for Health and Family Welfare, Mr JP Nadda on February 03, 2015 assured that all necessary assistance and support is being provided to the states to manage the situation. He informed that he has been in constant touch with chief ministers and health ministers of the affected states on the issue. "A 24*7 Outbreak Monitoring Cell of National Center for Disease Control (NCDC) is attending to public queries on H1N1 to keep them informed and to dispel fears and apprehensions, if any," claimed the minister. The health minister informed that the ministry has deputed senior level public health teams to Telangana and Rajasthan to assess the situation and assist the states in managing the current spurt in cases. The NCDC, Delhi through Integrated Disease Surveillance Programme (IDSP) and the state units have enhanced the surveillance for influenza like illness (ILI) and Severe Acute Respiratory Infections (SARI). They are also providing laboratory support in terms of testing, quality assurance, guidance, providing viral transport mediums and diagnostic reagents. While the affected states have adequate stock of the drug Oseltamivir, the health ministry also has sufficient stock of the medicine and Personal Protective Equipments. The central government has been advising the states, from time to time, to build capacity to manage the seasonal influenza. The states have been given guidance on risk categorization of patients and clinical case management. The Health Ministry and the states have also initiated awareness campaigns through print and visual media to educate and inform the public. ]]> <![CDATA[Bt cotton now occupies 95% of produce in India]]> https://biospectrumindia.com/news/95/5675/bt-cotton-now-occupies-95-of-produce-in-india.html https://biospectrumindia.com/news/95/5675/bt-cotton-now-occupies-95-of-produce-in-india.html Tue, 03 Feb 2015 11:35:00 +0530 During 2013-14, India cultivated a record 11.6 million hectares of Bt cotton planted by 7.7 million small farmers with an adoption rate of 95 percent, up from 11.0 million hectares in 2013. Notably, the increase from 50,000 hectares of Bt cotton in 2002 (when Bt cotton was first commercialized) to 11.6 million hectares in 2014, represents an unprecedented 230-fold increase in thirteen years. Brookes and Barfoot's latest provisional estimate indicated that India had enhanced farm income from Bt cotton by $16.7 billion in the twelve year period from 2002-2013 and $2.1 billion in 2013 alone, similar to 2012. In 2014, India cultivated 11.6 million hectares of Bt cotton, planted in almost 95 percent of that area. More than 77 lakh farmers cultivate the GM crop, said the International Service for the Acquisition of Agro-biotech Applications (ISAAA) in a report released on January 30, 2015. While regulatory authorities approved three hybrids in 2001, more than 700 types of Bt cotton seeds are now available in the Indian market. India has tripled its cotton production from 13 million bales to 40 million bales in the last 13 years, and is projected to overtake China to become to world's biggest cotton-producer in the near future. Currently, both produce 25 percent of the global market share. As per Dr CD Mayee, president, Indian Society for Cotton Improvement, "India has to break the impasse in genetically modifed crops as this cannot go on for long. The sucess of Bt cotton must be an eye opener for those who oppose the cultivation of genetically modified and do rumour mongering." "I am hopeful that government will take positive steps to bring back confidence of scientists", mentioned Dr Mayee who has also been the chairman of Agriculture Scientist Recruitment Board. Positive news from Maharashtra The Maharashtra government has given permission for field trials in some crops in genetically modified (GM) lines of rice, chickpeas, maize, brinjal and cotton. However, the decision to allow all the other field trials will be taken after closely monitoring and waiting for the results of these trials. The state joins Punjab, Delhi and Andhra Pradesh to approve open field trials in GM crops. As per reports, the decision was based on the recommendations of a state-level committee, headed by Mr Anil Kakodkar, the former chairman of the Atomic Energy Commission. Also, new Bt cotton hybrids have been approved in the state. When tested in the cotton belts of the Vidarbha and Marathwada regions, several next-generation Bt cotton hybrids, planted in high density in the fields, gave farmers 20 percent hike in their income. Mahyco and Ankur Seeds were involved in developing these hybrids, tested successfully on an experimental basis in Aurangabad, Jalna, Beed, Jalgaon, Dhule, Yavatmal, and Wardha. As per Mr Bhagirath Choudhary, director (India), ISAAA, "Development and deployment of high-density planting to maximise yield potential, popularising the system, and mechanization of cotton picking and harvesting is the way forward for Bt cotton in India." In the high-density planting system (HDPS), scientists intend to plant 1-2 lakh cotton plants in the same hectare of land. The spacing between two plants could be as low as 20 cm, instead of 90 cm-1 m for conventional cotton. ]]> <![CDATA[Fund to accelerate health technology startups]]> https://biospectrumindia.com/news/95/5766/fund-to-accelerate-health-technology-startups.html https://biospectrumindia.com/news/95/5766/fund-to-accelerate-health-technology-startups.html Tue, 03 Feb 2015 11:06:54 +0530 Unitus Seed Fund, Pfizer, PATH, Manipal Hospitals, and Narayana Health have jointly launched StartHealth, an innovative program to provide up to Rs 10 crore ($1.6 million) in grants and investments to very early-stage startups seeking to enhance access to affordable technology-driven healthcare products and services for the low-income masses in India. The program offers for-profit healthcare startups non-dilutive capital, hands-on support, access to expert advisors, medical facilities, and seed venture capital, enabling them to more efficiently and effectively complete development and scale their operations in India. The partners expect to select up to 5 startups in 2015. The announcement to this effect was made at the BioAsia 2015 conference being held in Hyderabad on February 02, 2015. "Over the past 2 years, we have met more than 150 healthcare entrepreneurs in India who had interesting innovations but who were not yet ready for seed venture capital," said Mr Dave Richards, managing partner, Unitus Seed Fund. "Rather than telling them to come back when they've progressed more, we can now engage, invest and support them immediately to get them on the road to commercialization success and scale." StartHealth Program Offers 2 plus Years of Funding & Expert Support With StartHealth, each emerging healthcare startup selected can take advantage of the funding, expertise and assets of the sponsoring parties, including upto Rs 50 lakh ($85K) of non-dilutive capital to fund immediate pre-seed business progress for 6 to 12 months. It will also have hands-on support from PATH, Manipal Hospitals and Narayana Health's staff, drawing from a pool of hundreds of healthcare and health industry experts. Besides that there will be access to expert networks of Pfizer, PATH, Manipal Hospitals, Narayana Health and Unitus, in India and globally and also the facilities of Manipal Hospitals and Narayana Health for pilots and market testing. Average Rs 1 crore ($165K) of seed venture capital and support from Unitus Seed Fund and its investing partners to prepare for growth and then to raise scale-up capital. "We are excited to bring our healthcare experience to the impact investment community in India to address health inequities through new and innovative business models," said Ms Dipika Matthias, director of PATH's Global Health Innovation Hub initiative. "We look forward to working closely with health technology-driven startups that are emerging as critical players in the effort to transform global health." With broad representation from various sectors, "BioAsia is the ideal platform for announcing the launch of this innovative program that aims to combine the business savvy of the start-up community with the global health access mission of governments and NGOs," she added. Taking Applications Now for Innovative Health-Tech Startups Areas the StartHealth partners are particularly excited about include low-cost diagnostic and monitoring devices connected to the user's and/or doctor's smartphone to enable more timely diagnosis and treatment. The other area is that of affordable healthcare cloud IT solutions to overcome service constraints for consumers in low-resource healthcare settings. Apart from that there is appropriate micro-device innovations for use in labs or clinical settings to improve the quality of care at lower levels of the healthcare system, such as primary care clinics. These are just a few areas where companies are innovating. The fundamental elements of success for a StartHealth company include an excellent entrepreneur with strong med/tech credentials, a concept that can reach lakhs, if not tens of lakhs of consumers/patients within about 5 years, and an opportunity for a strong financial return as the innovation scales over time. ]]> <![CDATA[Fighting the enemy within!]]> https://biospectrumindia.com/features/95/4395/fighting-the-enemy-within.html https://biospectrumindia.com/features/95/4395/fighting-the-enemy-within.html Tue, 03 Feb 2015 09:33:00 +0530 Truly a case of friend turned foe, the increased power of resistance shown by the microbes against the antibiotics can assume dangerous proportions. And this worry is not just on paper. The recent declaration of antibiotic resistance as one the three greatest global threats by the world health organisation (WHO) sounds highly ominous. Additionally, the rising cost of hospitalization in India along with resistant bacteria can make things further worse. While the researchers ought to engage themselves in containing it before it becomes a menace, the industry too is expected to take up its share of responsibility. "We must act urgently. The world is heading for a post-antibiotic era which will be devastating in this age of emerging infectious diseases. If we do not use antibiotics rationally, we will lose the power to fight common infections and minor injuries. We need to step up efforts to prevent antimicrobial resistance and change how we prescribe and use antibiotics," said Dr Poonam Khetrapal Singh, WHO Regional Director for South-East Asia, at the launch of a four-day regional meeting on antimicrobial resistance (AMR) recently in Jaipur. As per WHO's definition, the antibiotic resistance refers specifically to the resistance to antibiotics that occurs in common bacteria that cause infections while antimicrobial resistance (AMR) is a broader term, encompassing resistance to drugs to treat infections caused by other microbes as well, such as parasites (e.g. malaria), viruses (e.g. HIV) and fungi (e.g. Candida). Overexposure is the culprit Sold with or without prescription openly and easily, the unabated access to antibiotics has increased the risks. Within the past couple of years, new drug-resistant patterns have emerged and resistance has increased drastically putting more economic burden on the entire health care system. Resistant infections are often more severe, leading to longer hospital stays and increasing overall costs for treatment. "Now we had a problem for a while but we have not responded appropriately. Recently in a study, we found that between the years 2000-2010, the total antibiotic consumption went up by 36 percent globally. Out of that, 3 quarters were just from BRICS and India was on top. India is largest consumer of antibiotics in the world. Is that justified? Partially as we have huge population with disease .Not fully because we use the extreme drugs for common ailments," says Prof Ramanan Laxminarayan, vice president- research and policy, Public Health Foundation of India who suggests the need of balance as the antibiotics are very important too. He explains further, "Lack of antibiotics for children in rural pockets has led to death cases. At the same time, over the counter sale of antibiotics has caused overexposure. Especially in rural areas, children don't have access to antibiotics while in urban areas, it can be otherwise." "Antimicrobial resistance till date is most often associated with nosocomial infections (hospital based infections), and reports on these are limited in India. But there have been reports on emergence of superbug, NDM-1 which in itself is a disaster as it is resistant to even high-end drugs like carbapenems.," says Dr B R Das, president - Research and Innovation and mentor - Molecular Pathology and Clinical Research Service, SRL Diagnostics. "We being a private diagnostic setup and based on our internal data, would be considered as community acquired AMR data also seems worrisome. High level and continuously increasing levels of resistance has been noted for most of the gram negative and gram positive organisms. Yes, such data hints at the seriousness of the issue and should be considered as a threat ." "Of course it's an alarming concern," says Mr Arjun Juneja, head- Research & Development, Mankind Pharma, adding further, "All good intentions to control excessive antibiotic usage but with limited deed, has led to the situation where antibiotic resistance is grim. Resistance mechanisms are epidemic and create an enormous clinical and financial load on health care systems worldwide. There are no simple solutions to the problem. Fortunately, not all bacterial pathogens are resistant all of the time and many respond to first line treatment with antimicrobial agents administered in the community." Industry can play a significant role Experts point towards an urgent need of a powerful alliance comprising partners across the country from academic institutions, research organizations, pharmaceutical and biotechnology industries as well as most importantly medical fraternity that includes suppliers as well as heath care providers. All the partners must combine their experience, expertise and capabilities to create and test new economic models for antibiotic R&D to revive investments in this vital area. Simultaneously, we should examine how the efficacy of existing and new drugs can be maintained and preserved by defining their responsible and appropriate use. "Companies would be producing drugs and selling them since there is a need. Doctors are the best to decide and differentiate between the true need and estimate the chances of overexposure. While drug manufacturing companies can only be regulated in the presence of released governmental ordinance only. For eg. The recent pricing policy regulation on certain essential drugs for treatment of certain disease conditions like diabetes cancer which have badly hit the society, believes Dr B R Das. Mr Arjun Juneja feels that most of the pharmaceutical companies are now shirking away from the responsibilities of their own business missions. He says, "Regardless of the recognized and growing need for new antibiotics, only few new classes of antibiotics have been brought to the market in the last three decades, as industry has withdrawn from the antibiotic R&D arena because it is considered a high-risk, low-return market with little to satisfy stakeholder expectations. The onus is on academia to furnish information on the multifunctional aspects of microbial network interactions that will provide the discovery tools of the future." "The twin crisis of antibiotic resistance and the near empty antibiotic pipeline pose a very real threat to human health. Only biopharma companies in collaboration with stakeholders worldwide will be sufficient to address the crisis," rightly pointed out an expert. Health care providers can prevent antimicrobial resistance by ensuring prompt diagnosis and treatment of infections, prescribing antibiotics appropriately, and following infection prevention techniques to prevent the spread of drug-resistant infections in health care facilities. So role of patient, government bodies as well as health care providers comes equally in maintaining the balance between overexposure and dire need. Regulations are a big headache? Stringent regulations to control over the counter sale of drugs have been under the governmental agenda over a long time. The government of India constituted a 13 member task force under Dr R K Srivastava, then director general of health services, ministry of health to review the situation and subsequently the national policy on the AMR is available on the National Centre for Disease Control website. But immediate control and regulation seems difficult. Also the influence, role and reliability on private sector doctors needs to be taken into consideration to effectively lay down such regulations. Laws must be strict but nothing can be achieved until the number of medical doctors is not increased, believes Dr Virender S Chauhan, former director, International Centre for Genetic Engineering and Biotechnology (ICGEB). He adds, "We are sitting on a huge concern area. For people living in large numbers in big concentration, this will be biggest killer one time. All the poor countries are a hub of antibiotic resistance. We can just go forward and get the antibiotic drug. . Infact, the tribals of far off states don't have access to healthcare but the fact remains they have access to antibiotics. The condition is worse in China and India. Infrastructure is the major issue. While the harsher laws are very important, we have to produce large numbers of doctors." The World Health Assembly has now urged WHO to develop a global action plan against AMR by 2015. The plan is being organized around five main areas of concern: awareness; information on the magnitude of the problem; economic impact; rational use of antimicrobials and preventing infection. Surely the engagements with multiple stakeholders to ensure expertise should be harnessed, shared and used to greatest advantage. ]]> <![CDATA[ISAAA global biotech crop status report: Asia shows some progress]]> https://biospectrumindia.com/news/95/6268/isaaa-global-biotech-crop-status-report-asia-shows-some-progress.html https://biospectrumindia.com/news/95/6268/isaaa-global-biotech-crop-status-report-asia-shows-some-progress.html Mon, 02 Feb 2015 15:41:45 +0530 A record 181.5 million hectares of biotech crops were planted in 2014, an increase of more than 6 million hectares from 2013 during the 19th year of successful commercialization, stated a report released on January 30, 2015 by the ISAAA. "The accumulated hectarage of biotech crops grown in 1996 to 2014 equals, roughly, 80 percent more than the total land mass of China," said Clive James, ISAAA founder and report author in a live video message. "Global hectarage has increased more than 100-fold since the first plantings of biotech crops," he added during a press briefing held at New Delhi. More than 10 food, feed and fiber biotech crops have been approved, planted and consumed around the world during the 1996 to 2014 period. These crops range from major commodities such as maize, soybean, canola and cotton, to crops like sugar beet and sweet corn, and to fruits and vegetables like papaya, squash, sweet pepper, brinjal and, most recently, potato. According to the report, the United States continues to lead planting at 73.1 million hectares. Up 3 million hectares - a growth rate of 4 percent - from 2013, the United States recorded the highest year-over-year increase, surpassing Brazil, which has recorded the highest annual increase for the past five years. In 2014, Brazil increased planting of biotech crops by1.9 million hectares to 42.2 million hectares whereas Argentina maintained biotech crops hectarage at 24.3 million hectares. "The world is moving forward in adopting GM crops. There is a new momentum, new hope that India must realize to harness the benefits of this useful technology", said Dr C D Mayee, President, Indian Society for Cotton improvement. "It is high time we catch up with others in extending the technology beyond Bt cotton", said Dr Mayee. Biotech crops in Asia gain momentum The adoption rate of biotech cotton in China increased from 90 to 93 percent in 2014, while virus resistant papaya plantings increased approximately 50 percent. More than 7 million small farmers in the country continue to benefit from biotech crops and the latest economic data available indicates farmers in the country have gained $16.2 billion since the introduction of biotech in 1996. According to the report, India cultivated a record 11.6 million hectares of Bt cotton with an adoption rate of 95 percent. The number of Bt cotton farmers increased to 7.7 million with a substantial increase in cotton planting in 2014. "All of us in Vidharbha grow Bt cotton. We can't grow cotton without Bt technology. For us to be profitable and earn income for our family, we need a new set of seeds to help us control weeds, withstand drought and increase cotton yield to a next level" said farmer Vijay Atmaram Ingle from Akola, Maharashtra. Over the 13 year period, India tripled its cotton production from 13 million bales to 40 million bales in 2014 and is projected to overtake China to become number one cotton producing country in the near future. British economists Brookes and Barfoot estimate that India enhanced farm income from Bt cotton by $ 2.1 billion in 2013 alone. Bangladesh successfully began the commercial cultivation of vegetable Bt brinjal and became the 28th biotech crops country in 2014. Biotech crops were planted in 20 developing and 8 industrial countries that represent more than 60 percent of the world's population.Developing countries Vietnam and Indonesia granted approval for commercialization of biotech crops to begin planting in 2015. This includes several hybrids of biotech maize for importing and planting in Vietnam and drought tolerant sugarcane for planting as a food crop in Indonesia. The report highlights key benefits of biotechnology, including alleviation of poverty and hunger by boosting the income of risk-averse small, resource-poor farmers around the world. Latest global provisional information for the period 1996 to 2013 shows that biotech crops increased production valued at $133 billion; in the period 1996 to 2012 pesticide use decreased significantly saving approximately 500 million kg of active ingredient. In 2013 alone, crop plantings lowered carbon dioxide emissions equivalent to removing 12.4 million cars from the road for one year. These findings are consistent with a rigorous meta-analysis, conducted by German economists, Klumper and Qaim (2014), which concluded that GM technology has, on average, reduced chemical pesticide use 37 percent, increased crop yields 22 percent, and increased farmer profits 68 percent during the 20 year period of 1995 to 2014. ]]> <![CDATA[Robotics to dominate future of surgery in India]]> https://biospectrumindia.com/features/95/7120/robotics-to-dominate-future-of-surgery-in-india.html https://biospectrumindia.com/features/95/7120/robotics-to-dominate-future-of-surgery-in-india.html Mon, 02 Feb 2015 14:21:04 +0530 India got the taste of its first robotic surgery back in 2010 when for the first time, Gurgaon based Medanta hospital offered the same in cardiac, urology and gynaecology under one roof. It had joined hands with US-based Vattikutti Foundation and launched Medanta Vattikutti Institute of Robotic Surgery (MVIRS). Back then this minimally invasive surgical technique was watched with much awe as the development was considered historical in nature. From just 6 machines few years down the line, our country has reached 28 robotic machines in 2014. India at the moment stands at fourth position and is expected to be at 2nd position after the United States. Beaming with a great amount of confidence is the chairman of Vattikuti Foundation, Dr Raj Vattikuti who during his interaction with the BioSpectrum, threw light on the untouched aspects of surgical innovations. "Surgical robots are gradually making inroads into the Indian operation theatre. Vattikuti Foundation is committed to bring advance surgical technology to the common men. The Foundation is well on the way to achieving its target of 300 fully trained robotic surgeons. Soon, we will have fifty high volume robotic surgery programs all over the country," said Dr Vattikuti. The Vattikuti Foundation, a non-profit organization that was founded by Raj and Padma Vattikuti in 1997, is now aiming to install 40 machines by the end of 2015. Can the underdog section afford it? Among the major targets in the area are affordability, increase in volumes and developing skill sets. The cost of any Robotic surgery (also called computer aided digital tissue interaction) can be brought down between Rs 1 lakh to 1.5 lakh per surgery if the volumes go up from current 3.5 thousand surgeries to 20 thousand surgeries a year. To this question, the Foundastion chairman says that it is committed to make robotic surgery and other technologically advanced medical procedures of the future cost effective and available to underprivileged communities. It recently organized "Vattikuti Global Robotics 2015" three day multispecialty Robotic Surgery Conference (VGR) at New Delhi to provide a comprehensive and exciting program dedicated to the work of robotic surgeons in various specialties. Currently, the machines that could cost anywhere between 12-18 crore are installed at All India Institute of Medical Sciences (AIIMS), New Delhi; Post Graduate Institute of Medical Research (PGIMER), Chandigarh; Tata Memorial Hospital, Tata Memorial Hospital, Mumbai; Apollo Hospital, Delhi; Gangaram Hospital, Delhi and Medanta, Gurgaon. All these have functional systems that can deliver surgeries primarily in cardiology, gynaecology, urology etc. The cost though variable can go upto Rs 2.5 lakh which might be higher than any normal surgery but more safer than conventional ways. The foundation also unveiled 25 high volume fully trained robotic surgeons at the conference. With its 25 truly multidisciplinary programs with close to 150 skilled surgeons contributing to approximately 3,000 procedures per year, the foundation will continue its commitment of being a leading partner in the growth of robotic and other minimally invasive surgical techniques throughout India and the world. As per Dr Mahendra Bhandari, CEO, Vattikuti Foundation, "Robotic surgery has various advantages over the conventional methods of surgery greater surgical precision, increased range of motion, improved dexterity, enhanced visualization and improved access for the surgeon.Vattikuti Foundation is ushering in a new wave of innovation, analytics and cost savings in the field of surgical science. It was imperative that we convene the early adopters of robotic surgery at one event to help educate the industry on this ground-breaking new trend." The Vattikuti Foundation is present in the United States, Europe, Great Britain and India, has collaborated with multispecialty hospitals and institutes to develop independent multispecialty, state-of-the-art institutes within their main campus. It has also been involved in various philanthropic initiatives since 1997 in the area of healthcare and poverty alleviation. Will it ever be 'Make in India' for robotics? Presently, through the Vattikuti Foundation Robotic Surgery Initiative (VFRSI), the Foundation is supporting the growth of the "da Vinci Surgical system", manufactured by Intuitive Surgical, which represents the current state-of-the-art in a minimally invasive surgery and used in several surgical specialties including Urology, Colorectal Surgery, Cardiovascular Surgery, Gastrointestinal Surgery, Gynecology, Thoracic Surgery, Bariatric Surgery, Thyroid Surgery, Oncology, Children's Surgery and Transoral Surgery. On being asked about the monopoly of one company in the area, Dr Bhandari opined, "Monopoly in robotics like any other area won't last untill eternity. The scenario certainly is going to change. With right environment and policies, I am sure that things will change. However, the critical volume and skill sets will help in achieving the manufacturing in India in future." ]]> <![CDATA[USFTC nod for Sun-Ranbaxy merger]]> https://biospectrumindia.com/news/95/4705/usftc-nod-for-sun-ranbaxy-merger.html https://biospectrumindia.com/news/95/4705/usftc-nod-for-sun-ranbaxy-merger.html Mon, 02 Feb 2015 12:13:16 +0530 Drug major Sun Pharma is now a step closer to merge with Ranbaxy as US Federal Trade Commission (USFTC) has given a conditional nod for the proposed merger with Ranbaxy. Earlier, the Competition Commission of India (CCI) had granted a conditional approval to the merger in December 2014. The USFTC has also asked Sun Pharma to divest its interest in a generic anti-bacterial medicine (Minocycline tablets) to Torrent Pharma. The deal size could not be confirmed. According to the order by the FTC, Sun and Ranbaxy must sell Ranbaxy's generic Minocycline capsule assets to Torrent. Minocycline tablets are used to treat bacterial infections including pneumonia and other respiratory tract infections, acne, and skin, genital and urinary tract infections. Post merger, the combined entity will have annual sales worth $4.3 billion, making it the fifth-largest generic drug maker globally. ]]> <![CDATA[Sanofi invests in Apollo clinics]]> https://biospectrumindia.com/news/95/4699/sanofi-invests-in-apollo-clinics.html https://biospectrumindia.com/news/95/4699/sanofi-invests-in-apollo-clinics.html Mon, 02 Feb 2015 12:12:33 +0530 Apollo Health and Lifestyle Limited (AHLL) has announced that Sanofi India has invested into Apollo Sugar Clinics Limited (ASCL). Apollo Sugar is a disease management clinic. Through this investment, both Apollo and Sanofi would endeavour to expand Apollo Sugar to provide superior value to patients and Doctors with an enhanced geographic reach, and provide high quality outcome oriented set of services. Commenting on the collaboration, Dr Prathap Reddy, chairman and founder, Apollo Hospitals Group shared, "I am confident that with this investment, Apollo Sugar Clinics is even better positioned to offer patients advanced care and counselling for diabetes management. This is a good start towards improving the diabetes management programme in India and I am delighted to be partnering with Sanofi, a global leader in diabetes management. Our shared vision will provide a new approach to diabetes care to benefit patients in India and other parts of the world." Commenting on the investment, Mr Neeraj Garg, CEO, AHLL said,"The investments made by Sanofi, and the strong support of both our shareholders, enables us to grow our footprint to offer our services at many more clinics across India, and provide millions of Diabetic customers' access to world class care at their doorstep." ]]> <![CDATA[Biotech in Gujarat is worth Rs 4000 crore]]> https://biospectrumindia.com/views/95/5067/biotech-in-gujarat-is-worth-rs-4000-crore.html https://biospectrumindia.com/views/95/5067/biotech-in-gujarat-is-worth-rs-4000-crore.html Sun, 01 Feb 2015 11:02:00 +0530 GujaratDr Madhvi Joshi, sector specialist, Gujarat State Biotechnology MissionToday, Gujarat is amongst the top five biotech destinations in India. The state intends to promote biotechnology sector by building appropriate image, encouraging entrepreneurship, strengthening organizational colorations and forecasting business partnerships. For facilitating the development of biotechnology in the State, Government of Gujarat has constituted Gujarat State Biotechnology Mission, under the aegis of Department of Science and Technology. Over a period of time, Biotechnology companies in Gujarat have increased exponentially. As per GSBTM annual survey conducted, out of a total 151 companies in Biotech and allied areas in Gujarat, 43 percent are in Agriculture Biotechnology, 25 percent in Pharmaceutical & Healthcare Biotechnology, 17 percent in Bio-services, 9 percent in Industrial Biotechnology companies, 4 percent in Environmental biotechnology, 1 percent in Bioinformatics and 1 percent are in Food Biotechnology has been contributed. Almost 50 percent of the companies are located in Ahmedabad followed by 21 percent companies located around Vadodara making them major clusters of biotechnology industries. Total valuation of Biotechnology sector in Gujarat is Rs 4000 crore for the year 2013-14. Of which, 46 percent is contributed by the Pharmaceuticals & Healthcare sector, followed by Agriculture Biotechnology which contributes 21 percent and the rest is contributed by other sectors like Industrial biotechnology, Bio-services, Environmental Biotechnology, Food Biotechnology and Bioinformatics. Future Strategy for Biotechnology development in the state Up till now major milestones have been developing Biotechnology policy in state, establishing state level organizational mechanism for addressing biotechnology development, state supported and funded programs for holistic development of biotechnology, independent of DBT programs, creating specific research and business related infrastructure, widening base of biotechnology research, popularizing and developing modern high end technologies, stimulating entrepreneurship and biotech business and investments. GSBTM has developed long term strategy for growth and development of Biotech business. It includes support for research, technology development, technocommercialization, venture support, creating industry ready manpower, fostering international and national partnerships with specific program approach. The new draft policy for the biotechnology sector for state has been prepared and is advance stage of pipeline. ]]> <![CDATA[Healthcare biggies take pledge to follow ethics ]]> https://biospectrumindia.com/news/95/4477/healthcare-biggies-take-pledge-to-follow-ethics-.html https://biospectrumindia.com/news/95/4477/healthcare-biggies-take-pledge-to-follow-ethics-.html Sun, 01 Feb 2015 09:06:00 +0530 Recently, on the platform of 2nd Annual Event 'Aarogya Bharat 2025' Healthcare Federation of India (NATHEALTH) signed a Memorandum of Understanding (MoU) with Indian Medical Association (IMA) to develop a standard for an ethical environment for the Healthcare sector in India. Mr Anjan Bose, secretary general, NATHEALTH said, "Through collaboration between NATHEALTH and IMA we aim to define the Code of Ethics with appropriate transparency and in compliance with applicable laws, regulations and government guidance. Dr KK Aggarwal, Hony. secretary general, IMA said, "Self Code of Ethics is the need of the hour. Through this partnership we will work together to achieve the goal of 'Clean Medical World'. Not only in Healthcare delivery service but also in other sectors like Medical Technology Providers, Diagnostic Services, Health Insurance, Healthcare Education, Healthcare IT, Healthcare Publishers/Communicators and other segments." NATHEALTH unveiled ETHICS PLEDGE, all industry leaders that includes Additional Secretary, Ministry of Health & Family, C K Mishra, Dr. Prathap C Reddy, Founder Chairman, Apollo Hospitals, Shivinder Mohan Singh, Vice Chairman, Fortis Healthcare, Mr. Sushobhan Das Gupta, Managing Director, Johnson & Johnson Medical India, Dr. KK Aggarwal, Padam Shree Awardee Cardiologist & General Secretary Indian Medical Association, Mr Rajen Padukone CEO & MD Manipal Health Enterprises, Dr. Arvind Lal, Chairman, Dr Lal Pathlabs and Dr. Nand Kumar Jairam, Chairman, Columbia Asia Hospital pledged to build a robust and transparent platform to promote ethical practices in the healthcare ecosystem. ]]> <![CDATA[Irritable Bowel Syndrome treatment market could hit $1.5 billion by 2023]]> https://biospectrumindia.com/news/95/4098/irritable-bowel-syndrome-treatment-market-could-hit-1-5-billion-by-2023.html https://biospectrumindia.com/news/95/4098/irritable-bowel-syndrome-treatment-market-could-hit-1-5-billion-by-2023.html Sun, 01 Feb 2015 09:04:00 +0530 The global therapeutics market for Irritable Bowel Syndrome (IBS) is set to rise in value from $589.6 million in 2013 to $1.5 billion by 2023, representing a high Compound Annual Growth Rate (CAGR) of almost 9.9 percent, says research and consulting firm GlobalData. According to the company's latest report, this expansion will be driven primarily by rising IBS prevalence, along with the increasing uptake of Ironwood/Actavis/Almirall/Astellas' Linzess in the US and five European countries (5EU), namely the UK, France, Germany, Italy and Spain. Linzess' anticipated launch in Japan in 2017 will further boost the market. Mr Toli Koutsokeras, GlobalData's senior analyst covering immunology, says: "Of all IBS treatments, Linzess, which is used mainly as a second-line treatment and beyond in patients suffering from constipation-predominant IBS (IBS-C), is anticipated to contribute the highest revenues by 2023, with approximately $307.2 million across the US, 5 EU and Japan. "Linzess faces competition from Sucampo/Takeda/Abbott's Amitiza and the potential introduction of two additional IBS-C products, namely Synergy's plecanatide and AstraZeneca/Ardelyx's tenapanor, during the forecast period. "However, we still expect the drug's uptake to rise by 2023, due to increased physician experience with its use and continued marketing efforts by Ironwood, Actavis, Almirall and Astellas in their respective markets." Among the late-stage IBS pipeline therapies, GlobalData believes that Furiex's (Actavis') eluxadoline will generate the highest sales by 2023, with expected revenues of around $236.9 million following its anticipated launch in the US, 5EU and Japan in 2015, 2016 and 2018, respectively. The analyst comments: "Eluxadoline could become the first treatment for both male and female diarrhea-predominant IBS (IBS-D) patients in the US without prescribing restrictions, and the first product indicated for IBS-D in the 5EU. It will therefore be free from any direct competition once it enters the market in these regions." Despite the positive outlook for the IBS treatment market, GlobalData's report states that a number of major barriers will hinder further growth by 2023. These include the low IBS diagnosis rate, which is less than 50% in all seven major markets, resulting in fewer patients seeking medical attention and pharmacological treatments. Mr Koutsokeras continues: "Furthermore, the currently available IBS products demonstrate only modest efficacy, leading to low prescription and compliance rates. This has been a significant challenge to the global IBS therapeutics market over the past five years, with a high unmet need remaining for more effective drugs to manage patients." ]]> <![CDATA[Telangana CM lays foundation for Shantha's INR 460 cr insulin manufacturing facility in Hyd]]> https://biospectrumindia.com/news/95/4309/telangana-cm-lays-foundation-for-shanthas-inr-460-cr-insulin-manufacturing-facility-in-hyd.html https://biospectrumindia.com/news/95/4309/telangana-cm-lays-foundation-for-shanthas-inr-460-cr-insulin-manufacturing-facility-in-hyd.html Fri, 30 Jan 2015 13:02:00 +0530 Shantha, a Sanofi Company, announced the laying of the foundation stone in Hyderabad, by Telangana's Honourable Chief Minister, K Chandrasekhar Rao, for a new production facility to manufacture Insuman, a leading human insulin product from Sanofi's range of diabetes treatments. Sanofi will make an investment of INR 460 crore in this insulin facility. Located in Muppireddipalli (Telangana), the facility will be equipped with the latest technology to produce Insuman. This will be Sanofi's second plant aside from the Company's existing Insuman manufacturing plant in Frankfurt. The construction of the 13,400 square-meter building will begin immediately, with the site fully operational by 2019. The Honourable Chief Minister, Shri K Chandrasekhar Rao welcomed the commitment towards health, technology transfer and job creation by Shantha in Telangana State. Also, present on this special occasion, was Dr Varaprasad Reddy, the founder and chairman of Shantha Biotechnics. Speaking on the occasion, Honourable Chief Minister, Shri K Chandrasekhar Rao said, "I am delighted that Sanofi has decided to manufacture Insuman insulin in Telangana state, so that it helps the 65 million diabetics in India have better access to affordable insulin. We are shortly going to launch a new Industrial policy that will fast track projects and make Telangana one of the most favored destinations, for investments, in the world." Describing the significance of this project, Dr Harish Iyer, CEO, Shantha Biotechnics said, "Laying the foundation stone for the Insuman insulin manufacturing site is an important milestone in our journey at Shantha, to improve public health in India. For the first time, we will be able to manufacture insulin - in cartridges here. The new high technology facility will benefit from our existing biotechnology production expertise. This state-of-the-art facility will have the capability to ramp up manufacturing volumes to 60 million Insuman cartridges per year, within two to three years of commercial manufacturing." While Sanofi's Frankfurt facility will continue to manufacture the human insulin, Insuman, Shantha Biotechnics' INR 460 crore facility will contribute towards addressing the local demand for Insuman. Dr Shailesh Ayyangar, MD, India and VP, South Asia, Sanofi, said "By setting up a manufacturing site at Shantha Biotechnics for our diabetes product - Insuman,Sanofi is a front runner in its endeavor of addressing the growing epidemic of diabetes in India. Furthermore, the technology transfer and a successful collaborative effort within the Sanofi Group, underline our commitment to investing and 'Making in India'. We look forward to the successful 2/3 completion of the Insuman site construction, so that many more diabetic patients in India can have easier access to better disease management and quality of life." Type 2 Diabetes is a prominent non communicable disease (NCD). Globally, diabetes afflicts close to 382 million people with India alone accounting for over 65 million cases. The number of people with diabetes in India is expected to rise to 109 million by 2035. Out of the estimated 42 million patients on insulin in India, ~ 3.3 million patients are prescribed Regular Human Insulin (RHI) for diabetes management and control. The local production of Insuman will thus enable patients in India get access to the best available therapeutic options in diabetes. Post completion, the facility will operate with high performance work systems, which drive production efficiencies and save energy. The facility is expected to meet local and international demand. Insuman (human insulin) is used in people with diabetes (type 1 and type 2) who need treatment with insulin. It is produced from rDNA technology in Sanofi laboratories ensuring quality and purity. Insuman is licensed in 90 countries for use. Since its first introduction 17 years ago, more than 5 million patient-years with Insuman have been accumulated. In clinical studies with Insuman, more than 1,500 patients have been included. ]]> <![CDATA[AZ announces collaborations to use CRISPR technology]]> https://biospectrumindia.com/news/95/4237/az-announces-collaborations-to-use-crispr-technology.html https://biospectrumindia.com/news/95/4237/az-announces-collaborations-to-use-crispr-technology.html Fri, 30 Jan 2015 12:15:21 +0530 AstraZeneca (AZ) has announced four research collaborations aimed at harnessing the power of CRISPR, a pioneering genome-editing technique, across its entire discovery platform in the company's key therapeutic areas. The technology will allow AZ to identify and validate new drug targets in preclinical models that closely resemble human disease. AZ will share cell lines and compounds with its partners and work with them to publish findings of its application of CRISPR technology in peer-reviewed journals, contributing to broader scientific progress in the field. The collaborations complement AZ's in-house CRISPR programme and will build on the company's 'open innovation' approach to research and development. Dr Mene Pangalos, executive vice president, Innovative Medicines and Early Development, AZ, said, "CRISPR is a simple yet powerful tool that enables us to manipulate genes of potential importance in disease pathways and examine the impact of these modifications in a highly precise way. By combining the great science from our labs with these world-renowned academic and industry partners, we will be able to integrate this ground-breaking technology into our research and help accelerate the discovery of novel treatments for patients." AZ research collaborations are with The Wellcome Trust Sanger Institute, Thermo Fisher Scientific, Broad Institute/Whitehead Institute, and The Innovative Genomics Initiative. ]]> <![CDATA[â€œIndia will need additional 3.6 mn hospital beds, 3 mn doctors and 6 mn nurses by 2034â€?]]> https://biospectrumindia.com/news/95/4240/india-will-need-additional-3-6-mn-hospital-beds-3-mn-doctors-and-6-mn-nurses-by-2034.html https://biospectrumindia.com/news/95/4240/india-will-need-additional-3-6-mn-hospital-beds-3-mn-doctors-and-6-mn-nurses-by-2034.html Fri, 30 Jan 2015 11:56:39 +0530 PricewaterhouseCoopers (PwC) has launched a report called 'The Future of India:The Winning Leap' identifies non-linear solutions which could save $90 billion in capital costs in India's healthcare delivery infrastructure. Shortage of people and physical infrastructure needed to provide better healthcare contributes to the inadequate healthcare infrastructure. The ratio of doctors per 1,000 people is just 0.6. In Brazil and China, it's 1.8. And India has only 1.3 hospital beds per 1,000 people, significantly lower than the guideline of 3.5 beds defined by the World Health Organisation. Currently, the healthcare delivery system suffers from acute problems in terms of limited availability of hospital infrastructure and required workforce. To meet the desired outcomes in terms of hard and soft infrastructure capability, the healthcare delivery system will need to add 3.6 million beds, 3 million doctors and 6 million nurses over the next 20 years. This would require an investment of around $245 billion through traditional means. According to the report, India can also leverage its strength as a world leader in vaccine manufacturing (it contributes 60 percent of global production) to sharpen its focus on preventive care. Indian vaccine manufacturers such as Serum Institute of India, Bharat Biotech, and Biological E are renowned worldwide for their contribution to reducing the cost of vaccines to about $1 per dose, making preventive healthcare more affordable. Enabling universal access to healthcare through the adoption of Winning Leap solutions could help save $90bn in capital costs in India's healthcare delivery infrastructure. Several factors have resulted in poor health outcomes such as low life expectancy as well as high infant and maternal mortality rates. To bring about a Winning Leap in healthcare, India must increase life expectancy at birth from 66 years in 2012 to 71 years by 2024 and to 80 years by 2034. By adopting non-traditional solutions, infant mortality rate (number of infant deaths per 1,000 live births), could decrease from 44 to 31 in 2024 and to 12 in 2034. Similarly, the maternal mortality rate (number of maternal deaths per 100,000 live births), which is at 190 today, could decrease to 124 in 2024 to 27 in 2034. To achieve these targets, healthcare-sector players must focus on improving the reach, quality, and affordability of healthcare. Some of the non-linear solutions identified in the report are, Adoption of telemedicine and Shifting of point of care from hospital to patients' home will help meet the desired outcomes. ]]> <![CDATA[BE pledges 5-year price commitment to GAVI graduated countries]]> https://biospectrumindia.com/news/95/5381/be-pledges-5-year-price-commitment-to-gavi-graduated-countries.html https://biospectrumindia.com/news/95/5381/be-pledges-5-year-price-commitment-to-gavi-graduated-countries.html Fri, 30 Jan 2015 11:54:21 +0530 Ms Mahima Datla, MD, Biological E, addressing the GAVI Pledging Conference in Berlin, Germany, on January 26, 2015 said that: "As a company, we are deeply committed to improving the quality of human life and make immunization our biggest health priority. However, it's also true that access to immunization still continues to be a challenge." "We at Biological E will strive to ensure affordability of vaccines is not one of the contributing factors, so that countries can focus on sustainability and on overcoming other obstacles that are coming in the way of reaching that last child. So, today, to further our support to GAVI's mission, I am pleased to announce Biological E's offer of a 5-year price commitment to GAVI graduated countries. This commitment aims to ensure that graduated countries will have access to affordable prices that are comparable to GAVI-eligible ones," she added. Addressing the conference, Dr Seth Berkley, CEO, GAVI, said, "It is encouraging to see vaccine manufacturers increasingly recognizing the importance of sustainable vaccine markets for developing countries. The commitments made today will help us make more vaccine doses available at a lower cost and will support countries as they move towards financing and sustaining their own immunization programmes. This will lead to more children being protected and more deaths being averted." Biological E had earlier reduced the price of their Pentavalent vaccine by 30% in order to increase access as an example of a key market shaping collaborative outcome. The company together with the Gates Foundation, GAVI and UNICEF took the decision to reduce the price of Pentavalent vaccine. Ms Mahima Datla had mentioned that it was contextual for Biological E to make this reduction in order to improve access of immunization because of the company's late Chairman Mr Vijay Kumar Datla's vision of building a successful business that is also socially responsible and delivers value to shareholders and to the broader communities we live in. She reiterated Biological E's commitment at the conference further by saying, "We are proud to support GAVIs replenishment effort and with this pledge, we commit to working with GAVI to give donors, country governments and ourselves the opportunity to save more lives. In our own humble capacity, we will continue to play our part in reducing inequities in access to vaccines, particularly in the countries that we together serve." Ms Angela Merkel, the Chancellor of Germany, hosted the pledging conference, which was attended by the several Heads of the States of European Union, GAVI members, CEOs of various vaccine manufacturing companies and other delegates. ]]> <![CDATA[What do the biotech state heads have to say?]]> https://biospectrumindia.com/views/95/5810/what-do-the-biotech-state-heads-have-to-say.html https://biospectrumindia.com/views/95/5810/what-do-the-biotech-state-heads-have-to-say.html Fri, 30 Jan 2015 09:55:00 +0530 Telangana Mr Jayesh Ranjan, vice chairman & managing director, Telangana State Industrial and Infrastructure Corporation, Government of Telangana, Hyderabad. Telangana is a leader in biotechnology. Though historically there are many biotech clusters across India, Telangana biotech cluster is unique and is systematically planned. More than 200 biotech companies are housed in this cluster. The state offers complete ecosystem to nurture the biotech companies and help them grow, by providing required infrastructure and generating skilled workforce. Many world class research institutes like the CCMB and IICT are located in Telangana and this provides ample opportunities for vibrant convergence of key stakeholders- the academia and the industry to further enhance, enrich and encourage newer innovations and establishment of PPP models. The cluster of Genome Valley, located in Hyderabad has six smaller clusters excelling in different spheres of lifesciences like biotechnology, genomics, proteomics, pharmaceuticals, etc.Key initiatives for futureWe have further planned to foster this burgeoning sector by introducing certain key initiatives. The Telangana government has identified 14 core sectors for development of which biotechnology is one sector. We are planning to introduce sector specific policies that can address the needs and requirements of this sector to a large extent. The announcement of these policies will be made in the upcoming BioAsia event being held at Hyderabad from February 2 to 5, 2014. We are also planning to construct a new pharma city in the state which is three times bigger than the older pharma city and equipped with modern infrastructure, facilities and amenities, thus addressing some of the major shortcomings of the older city. We are also planning to construct an exclusive biotech park for medical devices. The government is planning to increase funding for the biotechnology sector, in order to support research and development in the state and thus fueling further development of companies and nurturing young startups. As a legacy of pharma driven lifesciences, we would like to capitalize on this sector and provide policy support and infrastructure support to give a new fillip to this sector. ]]> <![CDATA[The govt of MP has an investment friendly policy]]> https://biospectrumindia.com/views/95/4232/the-govt-of-mp-has-an-investment-friendly-policy.html https://biospectrumindia.com/views/95/4232/the-govt-of-mp-has-an-investment-friendly-policy.html Fri, 30 Jan 2015 09:02:00 +0530 Madhya PradeshMr Jitendra Narayan, MP, Biotechnology Council The Biotechnology Industry in Madhya Pradesh, as of now, largely consists of companies engaged in the production of biofertilizers and pharmaceuticals. Some of the main Biotech companies include Lupin, RANBAXY, Lilasons, Sun, etc.InitiativesThe Government of Madhya Pradesh has adopted an investment friendly policy in the past few years, which is likely to attract more industrial investment in the State. Biotechnology units will normally get all concessions/assistance that are provided to other industrial units as detailed in the Madhya Pradesh Industrial Promotion Policy, 2010. The industrial units in Biotechnology Park will be eligible for capital investment subsidy at the rate of 20 percent with maximum limit of Rs 20 lakh. Units with capital investment of more than Rs 5 crore will be eligible for capital investment subsidy at the rate of 15 percent, with maximum limit of Rs 1.5 crore. Industries in Biotechnology park will be eligible for interest subsidy on the term loans taken from any recognized financial institution or bank at par with industries established in backward category 'C' districts. The government is encouraging establishment of venture capital fund of Rs 100 crore with private participation. Plan for the Biotech Industry in Madhya PradeshMP has a high level of industrialization with a variety of Industries that would provide for newer area for undertaking research and also act as market for the Bio-industry segment of the Biotechnology Industry. For setting up of Biotech Industries in Madhya Pradesh a Biotech Park is proposed to be established in Indore. The proposed Biotechnology Park is to be developed over an area of 181 acres in Indore District, about 28 km from the main city and is located close to the Pithampur Industrial Estate. The Biotechnology Park is proposed to be developed in Public-Private Partnership. Private developer will be required to plan, finance, develop, operate and maintain the Biotechnology Park. MP Biotechnology Council will provide the land for the development of the Biotechnology Park. ]]> <![CDATA[USFDA issues 'import alert' on IPCA Labs]]> https://biospectrumindia.com/news/95/5923/usfda-issues-import-alert-on-ipca-labs.html https://biospectrumindia.com/news/95/5923/usfda-issues-import-alert-on-ipca-labs.html Thu, 29 Jan 2015 13:05:38 +0530 "We refer to our letter dated July 24, 2014 informing you about the outcome of USFDA inspection at our active pharmaceutical ingredients (APls) manufacturing facility situated at Ratlam (Madhya Pradesh), during which the company received certain inspection observations in Form FDA 483 from the USFDA, consequent to which the company voluntarily decided to temporarily suspend API shipments from this manufacturing facility for the US markets till this issue is addressed. We now wish to inform you that USFDA has issued an import alert to the said manufacturing facility on January 22, 2015," IPCA noted. However, the following four API's manufactured at the said manufacturing facility are excluded from the import alert: 1. Hydroxychloroquine Sulfate2. Propanolol Hydrochloride3. Trimethoprim4. Ondansetron "We are fully committed in resolving this issue at the earliest. We are also committed to our company's philosophy of highest quality in manufacturing, operations, systems, integrity and cGMP culture," it said. ]]> <![CDATA[Merck and Novo Nordisk join TransCelerate ]]> https://biospectrumindia.com/news/95/4012/merck-and-novo-nordisk-join-transcelerate-.html https://biospectrumindia.com/news/95/4012/merck-and-novo-nordisk-join-transcelerate-.html Thu, 29 Jan 2015 11:34:26 +0530 TransCelerate BioPharma has announced the addition of two new members, Merck & Co and Novo Nordisk, to the biopharmaceutical non-profit organization. TransCelerate is comprised of influential biopharmaceutical companies that are collaborating to help accelerate and enhance the research and development of innovative drugs across therapeutic areas. "The additions of Merck & Co. and Novo Nordisk further extend the reach of our workstream solutions that each aim to drive the efficient, effective and high-quality delivery of new medicines," said Mr Dalvir Gill, CEO, TransCelerate. In addition, TransCelerate has appointed Mr Briggs Morrison, executive vice president, Global Medicines Development at AstraZeneca, to the position of Chair of the Board of Directors. Mr Briggs Morrison, said, "I am very pleased to serve as the Chair of TransCelerate's Board of Directors and look forward to continuing to advance our mission of identifying and solving common drug development challenges. The year ahead will bring forth even more resources that will further facilitate the delivery of new therapies to the public faster." ]]> <![CDATA[BIRAC aims at increased role in creating translation facilities]]> https://biospectrumindia.com/news/95/8149/birac-aims-at-increased-role-in-creating-translation-facilities.html https://biospectrumindia.com/news/95/8149/birac-aims-at-increased-role-in-creating-translation-facilities.html Thu, 29 Jan 2015 10:28:02 +0530 BIRAC is presently focussing on setting up a preclinical toxicology facility by strengthening a private institution and make it accessible to researchers. The necessary ground work has already been completed. It aims to provide cutting edge skills of scientific leadership through industry-academia collaboration in this important research space, with a national mission focussing on innovation and translational research for accelerating discovery research to early development. BIRAC presents itself as the foundational building block in the national mission on biologics and biopharmaceuticals. "BIRAC has been able to provide platform to the scientists for entreprenuership and translation work," stated Dr Renu Swarup, managing director, BIRAC recently while speaking at the Australia Business Week in India 2015 event at New Delhi. Talking in partcular about the collaboration with Australian counterparts, Dr Swarup remarked further, "Since the iniatition of Indo-Australian Strategic Research Fund in 2006, much has been achieved so far. As we completed five years of partnership on various projects, there have been many accomplishments. So far eight rounds of funding have been completed and fifty projects supported These projects includes the ones on stem cells, neutraceuticals and bioremediation among other areas." BIRAC has already organized few stakeholder meetings and analysed the current 'art of the possible in India' to define the blue print and implement the mission. A Program Proposal Management Unit (PPMU) is also being created to assist conducting and coordinating the future activities. Dr Swarup emphasized on the need to focus on translational research. "We are trying to help build early translational capacity and skilled human resources for industry. The DBT has collaborated with European countries in both academic as well as industrial projects. Now is the time for next phase of collaboration," added Dr Swarup. Improved wheat production BIRAC aims to support a project on "Improved wheat for heat tolerance and climate resilience'' which addresses a very crucial area of crop biotechnology under the RAPID initiative in collaboration with USAID. The goal of the proposed project is to develop high yielding heat tolerant wheat cultivars for the Indo- Gangetic plains. BIRAC is presently exploring the possibilities of involving more Government funding agencies in this initiative and identified the major activities for taking this initiative forward i.e. setting up of centralized facilities for haploid production and genotyping, training of man on word power and the relevant wheat varieties. ]]> <![CDATA[Biotechnology industry in Assam is in its nascent stage]]> https://biospectrumindia.com/views/95/3862/biotechnology-industry-in-assam-is-in-its-nascent-stage.html https://biospectrumindia.com/views/95/3862/biotechnology-industry-in-assam-is-in-its-nascent-stage.html Thu, 29 Jan 2015 09:55:00 +0530 AssamDr J Balaji, CEO, Guwahati Biotech Park, AssamThe growth of Biotechnology industry in Assam is in its nascent stage. A few Biotech companies have started their entrepreneurial ventures with Guwahati Biotech Park (GBP). Few new entrepreneurs are also setting up their R&D units with GBP shortly. These companies will start their venture in some specific fields' of biotechnology like development of molecular assays, identification of genetic biomarkers for cancer, production of biofertilizer and biopesticide, testing kit development for low cost water filter, easy detection of contaminants of food and drinking water and it is envisaged that in the forthcoming years Assam as well as the North Eastern states will flourish as a major Biotech hub in the country. The government of Assam is committed to play the role of a catalyst and facilitator for the growth of Biotechnology Industry in Assam and establishment of GBP is the first step towards this commitment.Government of Assam has taken a major step in developing biotechnology industry in the state. In this endeavor, Assam is developing GBP in Guwahati, Assam. The Government of India has been taking a number of initiatives to speed up the growth of biotechnology by promoting development of innovative technologies, infrastructure, human resources and industry, which has helped this sector to gain global visibility. Department of Biotechnology (DBT), Government of India (GoI) has been spearheading the development of biotechnology research, education and entrepreneurship promotion through various grants and schemes. Realizing this, Government of Assam has undertaken a major project by developing Guwahati Biotech Park in Guwahati to facilitate faster penetration of biotech and pharmaceutical industries in the state by utilizing the abundant natural bioresources of the region.Government of Assam is providing all the necessary support for smooth functioning of GBP. Government has provided land of 85760 sq m to GBP and is likely to provide Rs 100 crore for land and infrastructure development of the park. GBP has a Technology Incubation Center (TIC) which has been set up to promote research based entrepreneurship and biotech industry development. The park will also develop Business Enterprise Zone, Business Support Facilities and Consultancy Cell. The TIC namely Guwahati Biotech Park Incubation Center (GBPIC) has been established in the temporary campus (20,000 sqft area) within IIT Guwahati premises. This Incubation Centre is being financially supported by DBT, and established through a tripartite agreement between Science & Technology Department, Government of Assam, DBT, GOI and IIT Guwahati. GBPIC is equipped with ready-to-use modular laboratories with modern Laboratory Work Stations and other utilities which can be leased out to entrepreneurs/ Firms/ Societies/ Scientists/ Students interested in pursuing their R&D activities in biotechnology and related areas. A Central Analytical Instrumentation Facility and five specialized facilities like Medicinal Plant Extraction, Bio-prospecting, Micro-propagation, Fermentation and Bioinformatics are being developed with a number of equipment essential for the relevant R & D activities. ]]> <![CDATA[Tau-based vaccines could transform Alzheimer Treatment]]> https://biospectrumindia.com/news/95/3891/tau-based-vaccines-could-transform-alzheimer-treatment.html https://biospectrumindia.com/news/95/3891/tau-based-vaccines-could-transform-alzheimer-treatment.html Thu, 29 Jan 2015 09:51:00 +0530 According to Mr Kyle S Nicholson, PharmD, GlobalData's analyst covering neurology, tau-based therapies for AD have traditionally been overlooked in favor of passive beta amyloid immunotherapies, such as Eli Lilly's solanezumab and Roche's gantenerumab and crenezumab. However, this interest appears to be receding after notable setbacks in recent years, and tau-based immunotherapies now have the potential to capture larger patient shares than these products. Mr Nicholson explained, "Tau is one of two peptides linked to AD, and is known for forming tangles of neuronal fibers inside the brain and causing cellular death. The other abnormal protein believed to cause damage that leads to AD is beta amyloid. Doubts are starting to arise over whether or not the removal of beta amyloid will affect a patient's cognitive status. Given that tau-related pathology might occur before beta amyloid becomes implicated, a tau-based approach may have a greater chance of eliciting measurable effects earlier in the disease's progression." The analyst notes that Johnson & Johnson and AC Immune have already entered into a three-year agreement to develop and commercialize tau-based immunotherapies for AD. These include ACI-35, which is currently in Phase IIb trials and positioned to be the first-in-class phosphorylated tau proteins vaccine inhibitor. However, Mr Nicholson added, "Despite its potential first-in-class status, ACI-35 will encounter significant competition from disease-modifying passive immunotherapies and oral beta-secretase inhibitors, which will start populating the market in 2018." "We expect AstraZeneca/Eli Lilly's AZD-3293 and Merck's MK-8931 to capture over 15 percent of the global AD space by 2023. ACI-35 will therefore likely enter a highly competitive arena several years after the beta amyloid therapies have already taken a significant patient share," the analyst concludes. ]]> <![CDATA[Indian vaccine firms pledge support to GAVI efforts]]> https://biospectrumindia.com/news/95/4134/indian-vaccine-firms-pledge-support-to-gavi-efforts.html https://biospectrumindia.com/news/95/4134/indian-vaccine-firms-pledge-support-to-gavi-efforts.html Wed, 28 Jan 2015 14:49:53 +0530 Indian too will contribute towards GAVI's goal of immunizing 300 million children in the world's poorest countries between 2016 and 2020, leading to five to six million lives being saved. The announcements were made on the eve of Pledging Conference being held in Berlin under the patronage of German Chancellor Angela Merkel, as GAVI aims to secure funding to ensure Gavi can reach its ambitious targets. Panacea Biotec extended its pledge, first made in June 2011, to support all Gavi graduated countries by offering a five-year price freeze on all vaccination programmes started with Gavi support. The price freeze commences from the first calendar year during which a country stops receiving Gavi support. Taking about the same, Dr Rajesh Jain, JMD, Panacea Biotec mentioned, "Panacea is proud to renew the pledge given on 13th June 2011 to support to all Gavi graduates, by offering a 5-year price freeze to help ensure sustainability of vaccination programmes, started with Gavi support. This pledge represents Panacea's ongoing devotion to social commitments and human welfare, which is rooted in our mission: 'innovation in support of life.' Our company principles of quality, innovation and continuous learning can also be demonstrated through our unrelenting efforts that results in the achievement of WHO prequalification status for our 'fully-liquid' 1 and 10-dose pentavalent presentations in 2013, thereby offering protections against hepatitis B, Haemophilius influenzae type b (Hib), diphtheria, tetanus and pertussis." Biological E is offering a five-year price commitment to Gavi graduated countries for its pentavalent vaccine. As per Ms Mahima Datla, managing director, Biological E, "We are deeply committed to improving the quality of human life and make immunization our biggest health priority. However, it's also true that access to immunisation still continues to be a challenge. We at Biological E. Will strive to ensure affordability of vaccines is NOT one of the contributing factors, so that countries can focus on sustainability and on overcoming other obstacles that are coming in the way of reaching that last child. So, today, to further our support to GAVI's mission, I am pleased to announce Biological E.'s offer of a 5-â€?year price commitment to GAVI graduated countries. This commitment aims to ensure that graduated countries will have access to affordable prices that are comparable to GAVI-â€?eligible ones." Serum Institute of India reduced its price for their pentavalent vaccines supplied to Gavi that is valued at approximately US$ 50 million dollars over the next two years. "It is encouraging to see vaccine manufacturers increasingly recognising the importance of sustainable vaccine markets for developing countries," said Gavi CEO Dr Seth Berkley. "The commitments made today will help us make more vaccine doses available at a lower cost and will support countries as they move towards financing and sustaining their own immunisation programmes. This will lead to more children being protected and more deaths being averted." The other four vaccine majors, GSK, Sanofi Pasteur, Pfizer and Jenssen too have committed funding support to the GAVI. GSK extended it price freeze commitment so that developing countries that graduate from Gavi support will be able to continue to purchase vaccines against pneumonia, diarrhoea and cervical cancer at significantly discounted Gavi prices for a decade after graduation. GSK also reaffirmed that if the company identifies new manufacturing efficiencies that reduce the costs of producing these vaccines, it will pass those savings on to Gavi and its donor. Janssen reaffirmed its pledge of making its pentavalent vaccine available at UNICEF prices to Gavi graduated countries over the next five years. Janssen also announced the launch of its pentavalent vaccine in cPAD, a compact Prefilled Auto-Disable injection system which helps improve injection safety. Pfizer agreed to reduce the price per dose for its pneumococcal vaccine, from $3.30 per dose to $3.10 per dose for the new 4-dose vial presentation, which is expected to be introduced under the Advance Market Commitment programme in 2016. This new lower price will be extended to all Gavi-eligible and graduated countries until the end of 2025. Sanofi Pasteur committed to expand the production of yellow fever vaccine to address chronic shortages, and promised to offer Gavi-level pricing for Gavi graduated countries until the end of 2018. The company also announced the expansion of its EPIVAC vaccinator training program in Nigeria, in collaboration with Agence de MÃ©decine PrÃ©ventive. ]]> <![CDATA[World leaders commit to protect poorest children with vaccines]]> https://biospectrumindia.com/news/95/3216/world-leaders-commit-to-protect-poorest-children-with-vaccines.html https://biospectrumindia.com/news/95/3216/world-leaders-commit-to-protect-poorest-children-with-vaccines.html Wed, 28 Jan 2015 13:14:11 +0530 Hundreds of millions of children living in the world's poorest countries will receive life-saving vaccines as a result of record-breaking financial commitments made on January 27, 2015, at the Gavi Pledging Conference, hosted in Berlin by German Federal Chancellor Angela Merkel. The new pledges, totaling $7.5 billion, will enable countries to immunize an additional 300 million children, leading to 5 to 6 million premature deaths being averted and economic benefits of between $80 and $100 billion for developing countries through productivity gains and savings in treatment and transportation costs and caretaker wages. Chancellor Merkel was joined in Berlin by Dr Jakaya Mrisho Kikwete, President of the United Republic of Tanzania, and Mr Ibrahim Boubacar KeÃ¯ta, President of the Republic of Mali, Ms Erna Solberg, Prime Minister of Norway, Mr Donald Kaberuka, President of the African Development Bank, Mr Bill Gates, Co-Chair of the Bill & Melinda Gates Foundation, ministers from more than 20 implementing and donor countries, civil society groups, CEOs of vaccine manufacturing companies, UN agencies and others who came together to secure commitments to fully fund Gavi-supported immunization programmes in developing countries between 2016 and 2020. In her statement at the conference, the first event of Germany's G7 presidency, Chancellor Merkel said: "There is a long way still to go but today's conference is an important milestone in the work of Gavi for the next few years to come. Please let us not fail, let us not lose courage but continue to put all our efforts into this wonderful work and thank all of those who are committed to this goal." "Today is a great day for children in the world's poorest countries who will now receive the life-saving vaccines they need," said Bill Gates. "We believe in the next 15 years, poor people's lives will improve faster than any other period in history and that access to vaccines provided by Gavi are critical to making that happen." The Gavi Pledging Conference, which was opened by Germany's Federal Minister of Economic Cooperation and Development, Mr Gerd MÃ¼ller, saw unprecedented engagement from donors, with many deciding to double or even triple their commitments to support Gavi in what will be its highest period of financial need. Additionally, China, Oman, Qatar and Saudi Arabia made pledges to Gavi for the first time. China's pledge means that all BRICS countries are now making financial contributions towards childhood immunization through Gavi. Developing countries are also increasing their financial contributions towards immunization. Between 2016 and 2020, Gavi forecasts that implementing countries will allocate a combined total of around US$ 1.2 billion, which is additional to the funding provided by donors, towards their Gavi-supported programmes through the Alliance's co-financing policy. This country ownership is vital to increasing the long-term sustainability of vaccine programmes. "Thanks to the joint commitments of developing countries, development partners, vaccine manufacturers and others, Tanzania is making great strides in protecting its children through immunization," said President Mr Kikwete of Tanzania. "The health and wellbeing of our children should always be our highest priority and in the future Tanzania will be able to fully support its own immunization programmes. Until that time I am pleased that the Gavi partners continue to recognize the importance of the work to improve immunization around the world." "We are pleased to be working with Gavi to ensure our children - including those living in the most remote and inaccessible areas - are protected with modern, effective vaccines," said President Mr KeÃ¯ta. "Thanks to today's historic pledges, children in Mali and around the world will have the opportunity to enjoy a healthy future through the power of immunization." Ahead of the conference, vaccine manufacturers committed to maintaining affordable vaccine prices, a move that will not only help Gavi buy more doses with the money secured but also increase the sustainability of vaccine programmes. Countries whose economic status means they are no longer eligible for Gavi support will still have access to many vaccines at the same price Gavi pays for a number of years. "Thanks to our donors, Gavi will be able to support developing countries to protect the lives of hundreds of millions of children," said Mr Dagfinn HÃ¸ybrÃ¥ten, Chair of the Gavi Board. "We believe that vaccines should reach every child because this is one of the most effective ways of reducing preventable deaths in the poorest countries. The commitments made today will ensure Gavi can make a telling contribution towards the global community's goal of ending extreme poverty by 2030." The US$ 7.5 billion raised today comes from a mix of pledges from 17 sovereign donors - for the first time almost all donors have made pledges for the full five-year funding period - the European Commission and private sector partners. Of the support from sovereign donors, US$ 252 million was committed to the International Finance Facility for Immunization (IFFIm). Additionally, Gavi announced today that the Gavi Matching Fund, a fund that doubles private sector contributions and impact, will be renewed for the 2016-2020 period with the support of the Bill & Melinda Gates Foundation, the Netherlands and other sponsors. The $7.5 billion pledged for Gavi's replenishment will be combined with $2 billion in already assured resources, including nearly $1.2 billion from IFFIm, for the 2016-2020 period to enable Gavi to meet the $9.5 billion cost of funding vaccine programmes in developing countries over the five year period. ]]> <![CDATA[Mylan expands hep C licensing agreement with Gilead ]]> https://biospectrumindia.com/news/95/4650/mylan-expands-hep-c-licensing-agreement-with-gilead-.html https://biospectrumindia.com/news/95/4650/mylan-expands-hep-c-licensing-agreement-with-gilead-.html Wed, 28 Jan 2015 11:46:28 +0530 The expansion agreement will include the non-exclusive rights to manufacture and distribute the investigational NS5A inhibitor GS-5816 and single tablet regimen of sofosbuvir (Sovaldi)/GS-5816, once approved, in 91 developing countries. The single tablet regimen is being evaluated in Phase 3 clinical studies for the treatment of all six genotypes of hepatitis C. If approved by regulatory authorities, the sofosbuvir/GS-5816 regimen would become the first all-oral single tablet regimen for all hepatitis C genotypes. A pan-genotypic therapeutic option is particularly important for developing countries, where genotype testing is often unreliable or not readily available. Mylan's president Mr Rajiv Malik said, "We are proud to partner with Gilead, once again, in our joint effort to quickly expand access to high quality, affordable medications to the more than 100 million people living with hepatitis C in developing countries. The potential to offer the sofosbuvir/GS-5816 regimen is particularly exciting, as it is an innovative compound that is being studied to treat all hepatitis C genotypes - a medical advancement that could significantly increase access to treatment." This agreement is in addition to the licensing and technology transfer agreement that Mylan entered into with Gilead in September 2014, which grants Mylan the non-exclusive rights to manufacture and distribute sofosbuvir and ledipasvir/sofosbuvir in 91 developing countries. Mylan also partners with Gilead on expanding access to high quality, affordable antiretrovirals for the treatment of HIV/AIDS in India and other developing countries. ]]> <![CDATA[UP has significant strength in the field of biotechnology ]]> https://biospectrumindia.com/views/95/7678/up-has-significant-strength-in-the-field-of-biotechnology-.html https://biospectrumindia.com/views/95/7678/up-has-significant-strength-in-the-field-of-biotechnology-.html Wed, 28 Jan 2015 09:53:00 +0530 Uttar PradeshDr Prahlad K Seth, chief executive, ITRC, Biotechnology Park, Uttar Pradesh Uttar Pradesh has significant strength in the field of biotechnology as R&D work is being undertaken in a number of CSIR and ICAR Institutes spread widely across the State. There are about five CSIR Institutes and ICAR has setup seven Institutes along with one Deemed University, two National Bureaux, one Directorate and 68 KVKs across the State. Lucknow itself has four CSIR labs namely, Central Drug Research Institute (CDRI), Indian Institute of Toxicology Research (IITR), Central Institute of Medicinal and Aromatic Plants (CIMAP) and National Botanical Research Institute (NBRI) and three ICAR labs, namely Indian Institute of Sugarcane Research (IISR), Central Institute of Sub-tropical Horticulture (CISH), and National Bureau of Fish Genetic Resources (NBFGR). Because of this, Lucknow was declared as Biotechnology City during 89th Annual Session of the Indian Science Congress. A Biotech Park Lucknow was setup jointly by Department of Biotechnology, Government of India and Department of Science & Technology, Government of Uttar Pradesh, which is presently housing approximately 18 biotech startups. Key initiativesThe State Government recognizes the significance of applications of biotechnology for its growth and economic development. It has brought out a Biotech Policy in 2004 which has been revised and the new biotech policy provides a number of incentives and proposes to set up centers of excellence, Biotech Parks and Biocenters across the State. The State has also constituted a Vision Group for the development of Biotechnology in the State of Uttar Pradesh. The recommendations of Vision Group are in process of implementation. The State is prepared to accept opportunities to introduce "value added" or "enhanced" crops with increased yields and nutritional value, improved resistance to diseases and pests, tolerance to abiotic stresses, reduced crop maturation time and longer shelf life.Soon the state government will be starting the Bio-entrepreneurship Program along with the ABLE to provide hands-on training and guidance to the biotechnology students to setup a startup within the state with perspective business program.At present, the allocated budget for the development of biotechnology is being sanctioned along with the budget of Council of Science & Technology, UP and a sum of Rs 1.50 crore is assigned for carrying out the activities of the State in the area of biotechnology. On the basis of the recommendations made by the Vision Group for the Development of Biotechnology in the State of Uttar Pradesh, a total of Rs 20 crore has been asked by the government (a total of Rs 100 crore in 5 years) for implementations of the various programs in the area of biotechnology.There is no dedicated institute in the field of biotechnology in the State. The State proposes to expand Biotech Park to serve the rural sector and therefore proposes to setup five regional centers, one Industrial Biotech Park and a National Biotechnology Translational Research Institute in the state. ]]> <![CDATA[Actavis to acquire Auden Mckenzie for $462 million]]> https://biospectrumindia.com/news/95/1462/actavis-to-acquire-auden-mckenzie-for-462-million.html https://biospectrumindia.com/news/95/1462/actavis-to-acquire-auden-mckenzie-for-462-million.html Wed, 28 Jan 2015 09:17:00 +0530 Actavis has announceed that it will acquire Auden Mckenzie for approximately $462 million (£306 million) in cash, plus a two-year royalty on a percentage of gross profits of one of Auden Mckenzie's products. Auden Mckenzie will be acquired on a debt free basis, and the transaction will exclude its real estate portfolio. The acquisition of Auden Mckenzie is expected to be immediately accretive to Actavis' non-GAAP earnings in 2015. Actavis currently markets more than 650 generic products in the UK, and has approximately 85 additional products under registration and development. The combination with Auden Mckenzie is anticipated to add approximately 175 new generic and branded products. It will also gain a pipeline of approximately 40 additional products, in various dosage forms, for treatments across a broad spectrum of therapeutic areas. "Auden Mckenzie is one of the leading pharmaceutical companies in the UK, and the opportunity to combine this profitable and growing company into the Actavis UK business demonstrates our commitment to invest in and expand strategically in our global generics business," said Mr Brent Saunders, CEO and president of Actavis. "Since its inception in 2000, Auden Mckenzie has established a notable position among the UK niche generic businesses by adopting a dynamic and entrepreneurial approach to developing and marketing generic medicines," said Mr Amit Patel, MD, Auden Mckenzie. He added, "We see in Actavis a company with the same entrepreneurial qualities. With its multinational resources and scope, Actavis will be able to achieve further growth based on our existing products and pipeline of new products." ]]> <![CDATA[Biocon's Syngene to raise Rs 3800 crore ]]> https://biospectrumindia.com/news/95/4327/biocons-syngene-to-raise-rs-3800-crore-.html https://biospectrumindia.com/news/95/4327/biocons-syngene-to-raise-rs-3800-crore-.html Tue, 27 Jan 2015 13:04:23 +0530 Syngene International, a wholly owned subsidiary of Biocon,is expecting to raise Rs 3800 crore through IPO (Initial Public Offering). Speaking to BioSpectrum, Ms Kiran Mazumdar Shaw, chairman and MD, Biocon said, "The board has authorised Biocon to sell 10-15 percent stock from its majority stake in Syngene via an offer for sale. We are expecting to raise close to Rs 3800 crore through IPO." The Board of Directors of Biocon has approved the initiation of the process of listing of Syngene and the appointment of merchant bankers for the purpose. The timing of listing of Syngene on the Indian stock exchanges is dependent on regulatory approvals and market conditions. Syngene is an internationally reputed custom research and manufacturing organization. ]]> <![CDATA[EC grants marketing authorization for Cerdelga ]]> https://biospectrumindia.com/news/95/4681/ec-grants-marketing-authorization-for-cerdelga-.html https://biospectrumindia.com/news/95/4681/ec-grants-marketing-authorization-for-cerdelga-.html Tue, 27 Jan 2015 11:55:08 +0530 Gaucher disease is an inherited condition affecting fewer than 10,000 people worldwide. A small number of adult patients who metabolize Cerdelga more quickly or at an undetermined rate, as detected by an established genetic laboratory test, will not be eligible for Cerdelga treatment. Cerdelga was approved by the USFDA in August 2014, and is under review by other regulatory authorities around the world. It is expected that Cerdelga will be available commercially in EU countries beginning in 2015 and over the next few years. Cerdelga is a potent, highly specific ceramide analogue inhibitor of glucosylceramide synthase with broad tissue distribution including to bone marrow. It reduces the production of glucosylceramide, the substance that builds up in the cells and tissues of people with Gaucher disease type 1. Cerdelga is indicated in the European Union for the long-term treatment of adult patients with Gaucher disease type 1 (GD1), who are CYP2D6 poor metabolizers (PMs), intermediate metabolizers (IMs) or extensive metabolizers (EMs). The majority of adverse reactions of Cerdelga are mild and transient. The most commonly reported adverse reaction with Cerdelga is diarrhea, in approximately 6 percent of the patients. The incidence of diarrhea was the same or higher with placebo than with Cerdelga in the placebo-controlled pivotal study. Less than 2 percent of patients receiving Cerdelga permanently discontinued treatment due to any adverse reaction. The EC approval was based on data from the Cerdelga clinical development program, the largest clinical research program ever conducted in Gaucher disease type 1, with approximately 400 patients treated in 29 countries. ]]> <![CDATA[Obama's Visit: Indo-US partnership in biotech, antibiotic resistance & biofuels]]> https://biospectrumindia.com/news/95/4377/obamas-visit-indo-us-partnership-in-biotech-antibiotic-resistance-biofuels.html https://biospectrumindia.com/news/95/4377/obamas-visit-indo-us-partnership-in-biotech-antibiotic-resistance-biofuels.html Tue, 27 Jan 2015 10:26:00 +0530 The Indo-American cooperation in science and technology has received a great boost due to the visit of President of United States, Mr Barrack Obama who alongwith Indian Prime Minister, Mr Narendra Modi have jointly appreciated the significant efforts undertaken by both sides in recent months to re-energize the strategic partnership. Both the leaders also committed to multi-sectoral actions countering the emergence and spread of antimicrobial resistance (AMR), and cooperation in training of health workers in preparedness for infectious disease threats. The leaders agreed to focus science and technology partnerships on countering antibiotic resistant bacteria and promoting the availability, efficacy and quality of therapeutics. A renewed commitment to Partnership to Advance Clean Energy Research (PACE-R), including extending funding for three existing research tracks of solar energy, building energy efficiency, and biofuels for an additional five years and launching a new track on smart grid and grid storage. The completion of an MoU between the Indian Ministry of Health and Family Welfare, Department of Biotechnology, Indian Council of Medical Research, All Indian Institute of Medical Sciences, and the U.S National Institute of Health and National Cancer Institute. The signing of the Joint Declaration of Intent between USAID and the Ministry of Human Resource Development on January 23 for technical support to the Indian Institutes of Technology (IITs), starting with IIT Gandhinagar, to strengthen research and entrepreneurship capabilities. Joint statement by the two heads of the nations, said, "We will continue to deepen our collaboration in science, technology, innovation, agriculture, health, education and skills. These are central to the future of our two countries; and also give us an opportunity to help others around the world." Earlier, the convening of the High Technology Cooperation Group on November 20-21, 2014 to shape a cooperative agenda on high technology goods, including export control-related trade in homeland security technologies, high technology manufacturing equipment including machine tools, defence trade, and fostering collaboration in biotechnology, pharmaceuticals, medical devices, and health-related information technology. ]]> <![CDATA[Working on Mission Immunization 2020 says health secretary]]> https://biospectrumindia.com/news/95/7123/working-on-mission-immunization-2020-says-health-secretary.html https://biospectrumindia.com/news/95/7123/working-on-mission-immunization-2020-says-health-secretary.html Tue, 27 Jan 2015 10:24:17 +0530 "No child should die beacuse of non immunization," opined Mr Lov Verma at the PEDICON 2015, an annual event organized by the Indian Academy of Pediatrics (IAP) at New Delhi. He also appreciated the efforts of IAP and mentioned that these were in sync with his ministry's initiatives. "In 2009, we were having 50 percent cases of polio but we eradicated it shortly as it was a sort of public movement. Current mortality rate per lakh of child births is 167. There has been sharp decline due to goverment schemes. Earlier in 1999, it was 590 per lakh births. Right interventions have helped a lot in the sharp decline and increased success in achieving goals," said Mr Verma at the 52nd national conference of IAP. There are close to 23,000 member of IAP in India. In its 52nd year of exixtence, the association has put the task of ensuring accountability and affordability in healthcare as a primary responsibility. It is working on the action plan with 3 point agenda including increasing partnerships, reducing infant mortality by 20 percent and building capacity by 2020. Talking about the Mission 2020, Mr Verma said," The Mission 2020 is laudable. New approach to interlink the departments will help in strengthening the efforts. Our department had launched Mission Indradanush Programme on December 25, 2014 which is an alternate programme to vaccinate left over children. We shall start special campaigns by June, 2015 to increase immunization coverage. It will include training of health workers." ]]> <![CDATA[Crystal ball Gazing 2015: Xcyton Diagnostics (India)]]> https://biospectrumindia.com/views/95/5855/crystal-ball-gazing-2015-xcyton-diagnostics-india.html https://biospectrumindia.com/views/95/5855/crystal-ball-gazing-2015-xcyton-diagnostics-india.html Tue, 27 Jan 2015 09:37:00 +0530 According to me the most exciting trend in healthcare is the acceptance of molecular diagnostics in public health space. We are expecting a lot of international diagnostic companies to set up their base in India-mainly marketing. For Xcyton, 2014 was an experimental year. It was a year of understanding the market and unraveling new opportunities. Most significant event is the conclusion of a Randomized Controlled Trial of our SES Sepsis in cases of neonatal sepsis. This trial showed that when our test is used as the primary diagnostic tool on day one of identification of sepsis and the patient is treated according to the results, 82 percent of neonatal deaths can be prevented.Our main focus for the next year will be to grow in the market and make our tests available to both public health and private sectors. We aim to excel in the market in mainly two areas Neonatal sepsis and Neurological infections. We are also planning significant R&D spending to automate our SES processes.Next year will be exciting for the pharma industries. The sector will see many Mergers and Acquisitions. However, biotech sector in India will still continue to struggle to raise money for good ideas. Overall life science sector will see great growth in biosimilars. ]]> <![CDATA[Crystal ball Gazing 2015: TrackMyBeat]]> https://biospectrumindia.com/views/95/5847/crystal-ball-gazing-2015-trackmybeat.html https://biospectrumindia.com/views/95/5847/crystal-ball-gazing-2015-trackmybeat.html Tue, 27 Jan 2015 09:34:00 +0530 There has been enormous interest in the uses of technology in the healthcare sector in recent years. Advances in technology have coincided with the rapid increase of 'lifestyle diseases' such as hypertension, diabetes, and cardiovascular disease. By using the former to manage and eventually slow the alarming rise of the latter, we get to put innovations into good use rather than simply innovating for the sake of it. In fact, some of the technology has existed for some time but we can only leverage its uses now with the penetration of smart phones among developing countries. By using this opportunity to disseminate as well as gather data, TrackMyBeat hopes to address critical health issues in both urban and rural populations.We are still in the start-up stage and have been concentrating in developing a core product which answers to the needs of our prospective users. Fund-raising has also been a major part of our activities during this past year.TrackMyBeat will unroll its improved web portal services along with several new devices in the coming year. Greater integration means that we will be able to better monitor a larger number of diseases. Customer feedback will also be essential as we continue to innovate. The objective is to create a solution that will eventually work for individuals, corporate clients, families, and health centers (rural and urban) in order to streamline the way healthcare is delivered in India.We will have a dual focus on product and sales in 2015. Both need to feed into each other in a virtuous cycle. A better product will drive sales while more sales will mean both the revenue and the user feedback necessary to improve upon the product.TrackMyBeat hopes that more players in the sector will mean greater sensitization of the public to the need of better managing one's health. Lack of information, and the generally negative perception of the public when it comes to lifestyle diseases and its management, is what TrackMyBeat sees as its biggest challenge. Constructive competition among industry players is necessary in order to move the population towards healthier lifestyle choices. ]]> <![CDATA[Dr Ashok Seth, Bill and Melinda Gates get Padma Bhushan awards]]> https://biospectrumindia.com/news/95/7544/dr-ashok-seth-bill-and-melinda-gates-get-padma-bhushan-awards.html https://biospectrumindia.com/news/95/7544/dr-ashok-seth-bill-and-melinda-gates-get-padma-bhushan-awards.html Mon, 26 Jan 2015 11:34:00 +0530 The NDA government announced the Padma Awards on Sunday with well known cardiologist Dr. Ashok Seth conferred with Padma Bhushan award. Over the past 20 years he has pioneered a number of angioplasty techniques in India and the Asia Pacific region. Along with him, Microsoft chief Bill Gates and his wife Melinda were selected for Padma Bhushan for their contribution in the space of HIV vaccine, as well as new intensive drugs to combat the disease. Well known Gynaecologist, Obstetrician & Laparoscopic Surgeon from Hyderabad Dr. Manjula Anagani leads the Padma Shri award list in the Medicine category. Others in the list includes, Randeep Guleria, currently the Professor and Head, Department of Pulmonary Medicine and Sleep Disorders at AIIMS; Lords Hospital Chairman Dr. K. P. Haridas from Kerala; Dr. Rajesh Kotecha 'Vaidya', Vice Chancellor, Ayurveda Physician, Gujarat Ayurvedic University,Gujarat; Chairman and Chief Interventional Cardiologist at Apex Heart Hospital Dr. Tejas Patel; surgeon Dr Narendra Prasad from Bihar; Prof. (Dr.) Yog Raj Sharma, Chief of Dr. Rajendra Prasad Centre for Ophthalmic Sciences, AIIMS; Dr. Nikhil Tandon, Professor of Endocrinology, AIIMS; Dr. Dattatreyudu Nori a noted Indian Radiation Oncologist, USA; Prof (Dr) Yogesh Kumar Chawla from Chandigarh; Jayakumari Chikkala of Delhi but hailing from AP, Dr Ambrish Mithal from Delhi; Dr Hargovind Laxmishanker Trivedi, Gujarat; Dr Raghu Rama Pillarisetti, USA; Dr Saumitra Rawat, UK and Dr Sarungbam Bimola Kumari Devi from Manipur. This year government honored 104 persons with Padma Awards. These include nine Padma Vibhushan, 20 Padma Bhushan and 75 Padma Shri awardees. The award will be given at a function later in the year. ]]> <![CDATA[Crystal ball Gazing 2015: Tex Biosciences]]> https://biospectrumindia.com/views/95/5850/crystal-ball-gazing-2015-tex-biosciences.html https://biospectrumindia.com/views/95/5850/crystal-ball-gazing-2015-tex-biosciences.html Mon, 26 Jan 2015 09:29:00 +0530 We expect to see more competition in the field of industrial enzymes. There is growing interest among all our customers to introduce enzymes for water and effluent treatment. We see these two areas as high growth areas in the years to come. As a company we did very well in 2014, currently growing at 35 percent per annum.In 2015, we would like expand our presence and increase the number of countries we export to. We are exporting to about 22 countries across the globe, and we like to grow our presence in at least another 10 more countries in 2015-16. We also intend to do well in the food processing industry which has good potential. We have benefited from the new government's policy which has stabilized inflation, reduced fuel costs and a good exchange rate for our exports. ]]> <![CDATA[Crystal ball Gazing 2015: Sartorius ]]> https://biospectrumindia.com/views/95/4884/crystal-ball-gazing-2015-sartorius-.html https://biospectrumindia.com/views/95/4884/crystal-ball-gazing-2015-sartorius-.html Mon, 26 Jan 2015 09:26:00 +0530 The Indian pharmaceutical industry is expected to revive growth at a faster pace in the coming years. This could be fuelled by the growing demand for economic drugs all over the world as well as slowdown in China due to stricter implementation of global quality norms. More importantly for us, fast-paced growth is likely to continue in the Indian biotech industry which is expected to increase in size to over $11 billion by 2017. This may be driven by a range of factors including growing demand for locally produced biotech drugs for degenerative diseases including cancer, intensive investments in R&D by Indian biotech majors, ever increasing availability of experienced personnel and stronger facilitation from the government of the day. The pharma regulatory environment across the world is getting increasingly stringent. As one of the biggest suppliers to the US market in particular, we need to step up our quality and manufacturing compliance culture in strict compliance with USFDA regulations. Increasing confidence in drugs manufactured in India is most significant. A holistic regulatory approach on all these aspects could pave the way for the 'Make in India' vision. Our investments in infrastructure, people, engineering and global standards over last years have borne excellent dividends since 2013. Sartorius Stedim India is now established as our center of excellence for Integrated Solutions with reusable technologies within the Sartorius Group. We export over three quarters of our engineering and production capacity to global clients in Europe, Latin Americas, and Asia. The New Year will be a stellar year for us in terms of both revenues as well as profitability, although we need to go a long way in terms of shop-floor productivity. Most of our business verticals and divisions have registered encouraging results. We are fully aware of the expectations from a knowledge-based industry like biotechnology or life sciences. Developing our Bangalore operations as a center of excellence for bioprocess solutions and setting up a fully equipped R&D lab have been two key steps towards meeting India's growing demands for designing and setting up complex bioprocess facilities for monoclonals and vaccines. This is part of our global 'Made by Sartorius' approach and also in line with the 'Make in India' clarion call from our Prime Minister. We have rolled out a go-to-market strategy that aims at aligning our people and knowledge resources to the expectation of our clients' process requirements. This includes talent acquisition and development in our sales and marketing resources in line with our strategy 2020 expectations in terms of market potential and industry trends. We will continue to strengthen our application specialist, integrated solutions and service teams to fulfil our clients' process, costs (capex/opex), and time to market requirements. While our focus will remain on biopharmaceuticals as a total solution provider, adjacent markets such as blood and plasma or certain functional food applications will be addressed by our centralized specialized teams.The demand supply situation for the life sciences sector will not necessarily change on a year-to-year basis. However, the global markets may not have any positive effect on this sector in the coming year. Hence, the industry may continue to streamline their operating costs as in most sectors in India. Operating costs in India remain challenging due to very high energy costs, ever growing personnel and logistics costs. The taxation regime may offer some relief if the govt of the day succeeds in rolling out economic reforms including the long awaited GST. Positive trends are expected as far as investments are concerned as industry is getting more and more hopeful of continuity in policies and governance from the government of the day. The new government has already sent out positive industry-friendly signals to provide impetus to industrial growth in general. These measures are expected to help the life science industry as well, as the sector has been identified as one of the key growth drivers of industry in India. As we all know, after thirty years we have a government elected with a clear mandate and many expect the present disposition to run the country for another ten years. It appears to be acting on the good policies of the past governments as well as bringing in a culture of disciplined functioning. Like most people in the industry, we are very appreciative of the leadership demonstrated by the current government, and believe that it will successfully play the facilitator's role for the industry. This will encourage industry managements to take risk decisions, build capacities, and address local as well as global potentials. The life sciences in particular has tremendous opportunities for growth, given the entrepreneurial and management talent available in India, access to capital and an ever growing need for high tech as well as mass biopharmaceutical products. ]]> <![CDATA[Crystal ball Gazing 2015: CREDI Health]]> https://biospectrumindia.com/views/95/5478/crystal-ball-gazing-2015-credi-health.html https://biospectrumindia.com/views/95/5478/crystal-ball-gazing-2015-credi-health.html Sun, 25 Jan 2015 09:17:00 +0530 The healthcare sector is picking up on the 'Google-Doctor-Google' trend. People are busy and they want instant solutions to their medical problems. Research indicates that people between the ages of 25 to 44 follow this trend where people first Google their symptoms, then consult a doctor, following which they turn to Google again to understand their diagnosis. Credihealth is in this 'Google-Doctor-Google' phase. The year 2014 has been overwhelming for Credihealth. Within months, we have served over 20,000 patients for their hospital needs. Such a response have given us tremendous encouragement. Credihealth aims to cover the entire Indian geography. We are planning to launch in 15 major cities across the nation in 2015. With this reach, we would be the only company in the pure hospitalization digital health care space. Our primary area of focus is to help people deal with all non-clinical pain points during their hospital journey. The idea is to set the benchmark for all healthcare services providers. People want transparency in healthcare now more than ever. There is a dire need to be educated on medical issues. Meanwhile, the industry wants to increase their reach to potential patients as well as continue transition towards evidence-based patient care. All stakeholders want healthcare cost containment and Credihealth wants to enhance medical experiences in India - one patient at a time. There is a 17 to 18 percent rise of CAGR in the healthcare industry. We see a 40 percent increase in the number of people making informed decisions in the digital healthcare space. We are confident of seeing these numbers increase by many folds in the next year. ]]> <![CDATA[Crystal ball Gazing 2015: Polyclone Bioservices]]> https://biospectrumindia.com/views/95/5011/crystal-ball-gazing-2015-polyclone-bioservices.html https://biospectrumindia.com/views/95/5011/crystal-ball-gazing-2015-polyclone-bioservices.html Sat, 24 Jan 2015 10:22:00 +0530 The shift from Chemistry synthesis approaches to enzymatic routes of API companies will see a major trend in the coming year and some biotransformation, biocatalysis areas will gain more importance and biology on the whole will garner lot of attention in the pharmaceutical industry in Asia Pacific and more so in India. The year 2014 was the year of learning as Polyclone delved into a new area unexplored before, that is enzyme engineering, and the results have been satisfying and response from the market as well as the industry has been optimistic. We have proven our technology to our prospects and forged formidable partnerships to bring about the needed transformation to the industry. The idea of actively becoming part of cleaner and greener initiative has been especially inspiring us to move forward aggressively. One of the biggest goals is to showcase the benefit of Insilico enzyme engineering and the possibilities of what computational biology can bring to the table directly benefitting the productivity of the company. So far, all the work we have done is with customers and confidentiality is maintained; hence for the first-time-starter companies we did not have a demonstrable validated data set and we are in the final stages of the whitepaper preparation which will help companies to understand the significance of in depth understanding of the enzyme's structural behavior in a dynamic environment and assessing the previously ignored quantum mechanics of the enzyme-substrate reaction. That said, our ambition is to be a significant player in supporting both pharma and non-pharma industries in bringing out more productive biocatalytic assays. Our primary focus will remain bringing awareness about how enzymatic approaches can be better in the long term and how complex reactions can be simplified. While doing this we will accept challenges to solve previously unaddressed segments of the market and show that we are willing to go the full hog. In summary, the main theme of 2015 will be to 'communicate and share'. Most SME Pharma companies in India are still traditional in their way of looking at the industry and business, with internet and e-commerce the world has become smaller and competition is no more local. These companies have to shed their fears of the 'New' and embrace technology and imbibe it in their strategy. The mindset of 'wait and watch' is still at large and being the first mover is seen as a disadvantage. This may not be a strength anymore as capturing markets can be done remotely at relatively lower costs today than 25 years ago. The question is, in comparison to what? However, there is growth overall in the industry, there is optimism in the country and improved governance will create transparency and better healthcare opportunity to the nation will lead to better offerings and a larger marketplace. But whether India will be seen as a significant player in the technology space is still an open question. More and more investment is going into market capture and scalability and less into real R&D and long term strategy and stability. As long as we celebrate the 'Patent Cliff' phenomena, chances of new technology and new products are diminished. ]]> <![CDATA[Crystal ball Gazing 2015: Jubilant Life Sciences]]> https://biospectrumindia.com/views/95/3447/crystal-ball-gazing-2015-jubilant-life-sciences.html https://biospectrumindia.com/views/95/3447/crystal-ball-gazing-2015-jubilant-life-sciences.html Sat, 24 Jan 2015 09:24:00 +0530 The trend in Drug Discovery sector will be soft with more or less all the major pharmaceuticals declaring their interests in late stage pipeline molecules. Biologics discovery is gaining momentum with several deals being signed for proprietary technology platforms and the major/mid biotech/pharmas allocating a good amount of their budget in this area. We are also observing an increase in collaborations between academics and pharma companies and the academics are increasingly becoming the third key element in the drug discovery sector. According to an industry report, the drug discovery outsourcing market for the current year is about $11.25 billion and is expected to grow upto $25 billion by 2019. Having said that, the biologics discovery is gaining importance in par with small molecules and is growing at a phenomenal rate. In short, drug discovery outsourcing sector will be highly competitive with increasing academic collaborations in drug discovery area and big pharma focusing more on late stage drug candidates.Both Jubilant Biosys and Jubilant Chemsys, wholly owned subsidiaries of Jubilant Life Sciences engaged in drug discovery and research services, and are regularly conducting several collaborative and integrated drug discovery programs. The collaborative or partnership model is an integrated discovery program across single or a portfolio of molecules. 2014 was an exciting year wherein we expanded our existing collaborations and signed new discovery deals with large, mid cap, and start-up virtual pharmas spanning across multiple therapeutic areas. The scientific community has been very dedicated and have achieved milestones, differentiated outcomes in various difficult discovery programs. Below are some highlights of the deals signed in the year 2014:â€¢ Jubilant Biosys and Orion Corporation, the largest pharmaceutical company in Finland, announced a drug discovery collaboration to discover small molecule inhibitors in the neuroscience therapeutic area.â€¢ Jubilant Biosys also announced the expansion of Drug Discovery alliance with Janssen Pharmaceutica aimed to deliver preclinical candidates to Janssen across multiple therapeutic areas.â€¢ Jubilant Chemsys, a wholly-owned subsidiary of Jubilant Life Sciences, and one of the most recognized drug discovery research services organizations from Asia announced the extension of its collaborative partnership with Infectious Disease Research Institute (IDRI) for TB drug discovery. Moving ahead, in the drug discovery space, we look forward to expanding our customer base and build long term partnerships so that we become our clients' offshore destination for innovation. We aim to strengthen our therapeutic area expertise by incremental investments into certain identified research areas and will continue investment on technologies to cater to the needs of biotech/pharma. We will be focusing on midcap/start-ups and virtual pharmas and with the already established set-up we look to on-board few more discovery programs to build a balanced portfolio with a combination of large/midcap/start-ups and virtual pharmas. With well enabled capabilities in Oncology, Metabolic Disorders, CNS, Pain, Inflammation, Fibrosis and Respiratory diseases, Jubilant has emerged as a leading collaborator for biotechnology and pharmaceutical companies worldwide. We aim to continue investing in translational research area for Target Identification/Target Validation (TI/TV) which is also becoming an integral part of drug discovery research. Our focus areas in 2015 will be: antibody drug conjugates to leverage on the growing demand for biologics discovery, strengthening our therapeutic area specific disease biology by incrementally investing in in-vivo models and exploring the possibilities to acquire new technologies with incremental investments or partnerships. We have also identified some thrust areas in discovery chemistry where we have already started investing and will continue our investment in these areas to strengthen our discovery chemistry.The pharma industry is experiencing pressure to cut down the cost of drug discovery and development due to spiralling healthcare costs and companies are looking for good strategic partners to address the increasing R&D cost. R&D cost v/s low productivity v/s shorter timelines are the daunting hurdles of pharma industry and to address this they are shifting focus from blockbuster drugs to rare and orphan diseases and specific target mutants to steady their pipeline. Pharma companies recent area of focus is the genetic linkage to diseases (as a drug that fails in Caucasian population might work in Asian population) and also in personalized medicine. We can see some moderate growth in small molecule drug discovery outsourcing market. It will be highly competitive for small molecule drug discovery with increasing academic collaborations and biologics discovery occupying its space in R&D budget. Trends such as acquisition and partnerships on new technologies, investment in research areas like TI/ TV, and demand trends for biologics will provide positive outlook to the drug discovery sector. ]]> <![CDATA[TAKE Solutions christens its lifesciences business as 'Navitas' ]]> https://biospectrumindia.com/news/95/4178/take-solutions-christens-its-lifesciences-business-as-navitas-.html https://biospectrumindia.com/news/95/4178/take-solutions-christens-its-lifesciences-business-as-navitas-.html Fri, 23 Jan 2015 11:49:11 +0530 TAKE Solutions has announced the launch of Navitas, a pure-play lifesciences solutions company. The new entity brings together the teams of TAKE Life Sciences and WCI Consulting. The capabilities of the new lifesciences arm of TAKE Solutions covers industry leading networks, strategic and change management consulting, technology and services which are focused on the Clinical, Regulatory, Safety and Compliance domains. The new pure-play Life Sciences solutions company will cater to clients ranging in size and complexity. Mr Srinivasan H R, vice-chairman and managing director, TAKE Solutions and chairman, Navitas said, "There is a demand in the global Pharma/Lifesciences market for regulatory compliance and customized solutions to meet business needs. The total addressable market of the Lifescience industry is valued at $15.9 billion. Our move to create a new brand is to meet the demand of this market in time to emerge as a competent and differentiated player. We have seen immense positive growth in this segment with our solutions in this space resonating well with customers. Our plan is to capitalise on it, gear upto meet the changing business environments and compete with industry leaders". ]]> <![CDATA[Biocon Q3 profit dips 11% over Q2]]> https://biospectrumindia.com/news/95/4179/biocon-q3-profit-dips-11-over-q2.html https://biospectrumindia.com/news/95/4179/biocon-q3-profit-dips-11-over-q2.html Fri, 23 Jan 2015 11:07:57 +0530 Biocon has announced its Q3 FY15 results. The third quarter revenues stood at Rs 779 Crore recording Rs 91 crore net profit. The company's profits have shown 11 percent dip compared to previous quarter and have shown 13 percent decrease year on year (Y-o-Y). Income has shown growth of 8 percent Y-o-Y and 1 percent sequentially. The Biopharma segment recorded revenues of Rs. 436 Crore in Q3FY15, growing 4 percent YoY. And research service Research Services delivers 20 percent growth. The Branded Formulations business recorded revenues of Rs. 105 Crore in Q3 FY15, registering a growth of 6 percent YoY. For 9M FY15, the vertical grew 11percent YoY, in line with the Indian Pharmaceutical Market (IPM). The Research Services segment recorded Q3 sales of Rs. 220 Crore, delivering a growth of 20 percent YoY. Commenting on this performance, Mr Peter Bains, Director, Syngene International, said, "We are pleased with this quarter's robust performance which includes good traction from recent capacity expansions. Our order book is strong and we see this momentum continuing through Q4. We are on track to achieve our full year revenue growth guidance in the high teens." Biocon, through its wholly owned subsidiary Biocon Research Limited (BRL), concluded the sale of its 10 percent stake in Syngene to M/s IVF Trustee Company Private Limited. Post this stake sale, the holding of Biocon (including stake held by Biocon Research Limited) in Syngene stands at 85.54percent. Commenting on the quarterly performance and highlights, Chairman and Managing Director, Kiran Mazumdar-Shaw stated, "A significant ramp up in R&D expenses this quarter reflects advances made in multiple R&D programs. Two programs viz. trastuzumab and glargine are progressing well in global Phase III clinical trials, while two other biosimilar programs have entered the clinical stage globally. This clearly positions Biocon as having one of the largest portfolio of Biosimilars in the clinic. " She further added, "Our Research Services arm, Syngene, has reported the best quarter thus far at Rs. 220 crore which bodes well as the company prepares for a public listing. Biocon continues to invest in its uniquely differentiated Biosimilars portfolio, which straddles both Insulins and Monoclonal Antibodies. We are confident this will deliver short term growth in the emerging markets and drive long term value creation across global markets." The company inducts former TEVA CEO Dr Jeremy M Levin and Harvard Medical School Professor Dr. Vijay K. Kuchroo, as additional independent directors on its Board. ]]> <![CDATA[Crystal ball Gazing 2015: Rasi Seeds]]> https://biospectrumindia.com/views/95/5994/crystal-ball-gazing-2015-rasi-seeds.html https://biospectrumindia.com/views/95/5994/crystal-ball-gazing-2015-rasi-seeds.html Fri, 23 Jan 2015 10:15:00 +0530 We are hopeful that the road block for doing research including GM crop field trials will be removed by Kharif 2015. If it happens Industry will revive the activities. The industry is hoping that a favorable push will happen from the government. As such there is positive mood in the Industry. Our company performed better than 2013 and we have grown. We are confident that we will have substantial growth in 2015 with emerging new products. However, there will not be any appreciable growth in the agri-biotech sectorIn 2015, we look forward to achieve deep penetration in all markets with our new products in cotton, corn and rice. ]]> <![CDATA[Crystal ball Gazing 2015: MedGenome]]> https://biospectrumindia.com/views/95/5986/crystal-ball-gazing-2015-medgenome.html https://biospectrumindia.com/views/95/5986/crystal-ball-gazing-2015-medgenome.html Fri, 23 Jan 2015 10:02:00 +0530 Genomics has seen rapid advances in the technology of decoding the DNA, triggering a revolution in our ability to understand the genetic and molecular basis of health and disease. We expect these innovations to continue further reducing the cost of genome sequencing. In light of recent advances, genetic testing will be increasingly used in a clinical setting for diagnosis, prevention, treatment and management of a wide variety of diseases with an underlying genetic cause. Genomic biomarkers as companion diagnostics are helping the pharma majors to provide more targeted therapies. The relevance of genomics in exploratory research and drug discovery is rightly understood and would be something to watch out for in the near future.Predictive medicine is expected to grow in the coming years. It uses advances in accurate technologies in medicine, genomics, Proteomics, cell biology, imaging etc. and allows us to predict how, when, and in whom a disease will develop. This could be a new revolution in human health care where genetic information contained in an individual's genome is interpreted to predict future predisposition to diseases. The ability to predict whether a child in utero will be born with certain disease traits is a powerful application of predictive genomics in pre-natal settings. Further, familial diseases can be tracked by analyzing disease genes for functional alterations and this knowledge can be used to counsel families - to make them more aware of the disease and take preventive steps before the symptoms become apparent. As an example, finding that an individual has loss of function alterations in genes such as BRCA1 and BRCA2 can be used to predict that the individual has a much higher chance of getting breast and ovarian cancer than an individual whose BRCA1 and 2 genes are functional. This knowledge can help families to cope with the disease burden, take steps so that disease can be detected early and educate others in the community of the value of predictive genomics. The hope underlying such testing is that early identification of individuals at risk of a specific condition will lead to reduced morbidity and mortality through targeted screening, surveillance, and prevention.2014 was a busy year for MedGenome. We expanded our presence to Pan-India offering end-to-end integrated solutions for clinical diagnostics. We opened up our new office in Gurgaon and expanded our lab operations in Bangalore. We have started our proteomics facility with our collaborators in Narayana health city in Bangalore, complementing our Next Generation Sequencing (NGS) lab facility at the same premises. We have built our hospital collaborations further in 2014 wherein we engage with the institution to provide solutions that cater to the patients visiting the hospitals. We have also expanded our gene panel offerings to cover major disease areas such as Oncology, cardiology, ophthalmology, neurology and nephrology. MedGenome's proprietary cancer analytics platform, OncoMD, has been expanded with newer features and applications for both diagnostics and research. We have been in discussions with multiple clients globally to offer this platform both as standalone installation and as a software-as-a-service license. MedGenome's capabilities and services are also finding attention among genome researchers who want to partner for exploratory research and drug development. The goal is to continue to offer services and solutions to the healthcare market in a customized manner. We will continue to strengthen our presence in clinical diagnostics in India. We want to continue to collaborate with major hospitals and academic institutions in India. We are growing our software and bioinformatics team. Deriving meaningful insights from genomic data is a challenge. We have developed proprietary tools and analytics to convert this data into useful insights and want to continue to scale it up. This is considering the fact that our sample volumes are increasing with our Bangalore lab facility expanding. Our recruiting team will be very busy in the coming year! We are seeing lots of traction for our bioinformatics solutions from global players as well, which is something we will plan for.Another area for genomics application is Prenatal Testing (NIPT) where the impact can be very high. It is estimated that genetic/chromosomal abnormalities occur in about 1 of 200 live births and account for at least half of all miscarriages that occur during the 1st trimester. Genomics can provided a much needed option for parents who are in need. In the coming year, MedGenome would develop capabilities to introduce safe, comprehensive and highly accurate non-invasive prenatal testing to Indian population. Unlike the traditional genetic testing like amniocentesis, non-invasive tests causes no risk to the fetus, which makes us very excited about such technology.The future of the industry is promising. The evolution of Next Generation Sequencing (NGS) has significantly reduced the time and cost for genome analysis. However it brings with it a necessity for better data management and conversion to clinical application. Doctors and hospitals in India are also taking a big step in educating their patients. Advances in bioinformatics have improved the quality of insights generated from the analysis of genomic data; but the flood of genomic information continues to challenge our existing analytical capabilities. Certain factors like regulatory body approval, and reimbursement from insurance companies may prove to be crucial in determining the growth of this industry. In the western world, insurers have started accepting genomic tests in their formulary as it is expected to reduce the cost of down-the-line treatment. In India, these tests are yet to be offered at affordable prices. There is also a great need for clinicians who have a good understanding of genomics and its clinical significance. The patient journey must be well managed so that if a particular condition is identified, the experts are brought in to handle the situation and help the individual. There is a dearth of genetic counsellors who can explain genomics findings to the affected individuals and their families. In addition to this, factors like lack of resources for effective data analysis, cost of technology, lack of baseline genomics data of Indian origin and unclear policies on intellectual property rights also pose hindrances to the industry.Overall, genomics offers a plethora of opportunities that are yet to be seized. The greatest benefit that can come from the application of genomics to human health care is to provide prescribers and individuals with useful insights into their genotype which will enable them to take preventive/curative steps for their disease management.Lifesciences sector will have challenges. Patent expiries will affect the performance of the firms leading them to optimize their investments. Targeted medicines will be a strategy that the sector will adopt where genomics will play a major role. We can expect to see significant advances in personalized medicine in the coming year. Technology is expected to enable better solutions in life science space. Mergers and acquisitions will be sought after, considering the need to uphold shareholder value, utilize synergies and increase effectiveness. Investment climate is also improving within the biotech space. Innovation is the key even in these tough times. Gone are the days of blockbuster drugs. It is more about assets, providing efficacy which are niche but adding up to a sizeable business. ]]> <![CDATA[Traditional medicine must get its dues, says Dr Brahmachari]]> https://biospectrumindia.com/news/95/7162/traditional-medicine-must-get-its-dues-says-dr-brahmachari.html https://biospectrumindia.com/news/95/7162/traditional-medicine-must-get-its-dues-says-dr-brahmachari.html Fri, 23 Jan 2015 09:53:00 +0530 Dr Samir Brahmachari feels that despite adverse opinions at times, one has to take the risk and be persistent with the ideas to gain experience. He was refering to the cricism of ayurveda and its dismissal as a science most of the times. Speaking to BioSpectrum's Rahul Koul on the sidelines of an event, he mentioned,"It is important to remember that 1.3 billion population of India cannot be treated by the modern medicine when 65 percent of them are still dependent on traditional medicine in one way or the other. So, why not use this to identify the genetic connection of fruits/foods suitable for the disease phenotypes." The core focus, Dr Brahmachari says should be on the affordability and creation of flipcart like mechanism where the delivery of customized medicine is possible through telemedicine facilities. Dr Brahmachari is known for coining the word, "Ayurgenomics" in India and brain behind the TRISUTRA (Translational Research and Innovative Science Through Ayurveda), a unit of the Council for Scientific and Industrial Research (CSIR) functional at its Institute of Genomics & Integrative Biology (IGIB), New Delhi. While it was conceptualized long back in 2002 by Dr Brahmachari, the recognition for him and his team came as late as in 2008 when a landmark study, the first of its kind in the world, revealed that it is possible to identify groups within normal individuals of the populations, which could be predisposed to certain kind of diseases, and also might respond differently to drugs. This is also when the word 'Ayurgenomics' was coined by the authors of the study. Based on one of the leads from gene expression differences, a genetic marker associated with high altitude adaptation and a high altitude illness, EGLN1 was identified. The study thus provided a novel molecular framework for integration of two contrasting disciplines. Elaborating further on this, the former DG of CSIR in a higly enthusiastic tone, mentioned, "When we imagined this project back in 2001, our knowledge was zero. But we realized that the genomic research is moving towards predictive personalized medicine. Therefore, we thought ahead of times and established a network of scientists to explore the existing traditional knowledge ignored so far. The principle we are using is very similar to the sub-group classification employed 4000 years back in Ayurveda." ]]> <![CDATA[Crystal ball Gazing 2015: Eppendorf India]]> https://biospectrumindia.com/views/95/5625/crystal-ball-gazing-2015-eppendorf-india.html https://biospectrumindia.com/views/95/5625/crystal-ball-gazing-2015-eppendorf-india.html Fri, 23 Jan 2015 09:13:00 +0530 Indian pharmaceutical and biotech companies are investing a lot in to research and this is expected to push the demand for the analytical and life sciences instruments. We expect a lot of funds to be released by the government to academic and research institutions. There is an increased interest in creating several incubators for startups in biotechnology. The analytical and life sciences instrument industry is going through lot of consolidation due to mergers and acquisitions. This will impact the choice for the customers. The year 2014 has been a very tough year as the public institutes did not purchase enough due to non-availability of funds. The demand in the industry was good. Also due to elections, for centre as well as for various states, the overall market demand was lower. We hope the situation will change in 2015 as several new projects are being approved. Eppendorf has recently entered the cell culture consumables market, and we expect to launch several new products in this area. We will also be working on the health care industry as hospitals and diagnostic labs are investing on quality products. We have also received NABL accreditation for calibration of speed, time and temperature. This will enable us to support our customers in regulated markets with calibration and validation traceable to international standards.The lifesciences sector is expected to grow. Pharmaceutical and biotech companies will continue to invest in R&D as demand for their products are picking up. It is very early to comment on the impact of the new government on the industry. It is just 6 months since we have had the new government. With the government's focus on 'Make in India' and exports, we expect the demand to increase. ]]> <![CDATA[H1N1 takes 11 lives in Hyderabad]]> https://biospectrumindia.com/news/95/5901/h1n1-takes-11-lives-in-hyderabad.html https://biospectrumindia.com/news/95/5901/h1n1-takes-11-lives-in-hyderabad.html Thu, 22 Jan 2015 12:09:02 +0530 H1N1 is creating havoc in Hyderabad and has already claimed 11 lives in the last 30 days, while over 150 people have tested positive for the virus. Reportedly, two doctors have also tested positive for swine flu, triggering panic among the medical staff. Telangana Chief Minister Mr K Chandrasekhara Rao (KCR) has asked the state health department to initiate emergency measures to tackle the virus. Mr KCR has also briefed Prime Minister Mr Narendra Modi on the situation and has requested for central medical teams to be sent to Hyderabad. "I have requested the PM to dispatch medical teams to help the state health officials. More medicines have also been requested," the CM said in a statement. State Health Minister Dr T Rajaiah, however, said that there is no reason to panic. "The prolonged chilly weather has compounded the problem. There is no reason to panic but we have to be careful. One reason why we are able to detect so many cases is because of the excellent virology lab we have in Hyderabad,'' said Dr Rajaiah. Officials are requesting people to wear nose masks when visiting hospitals and in public places. Since January 1, 2015, 173 swine flu cases have been detected in Telangana and Andhra - 169 in Telangana and 4 in Andhra, the officials informed. ]]> <![CDATA[Crystal ball Gazing 2015: Fermenta Biotech]]> https://biospectrumindia.com/views/95/5853/crystal-ball-gazing-2015-fermenta-biotech.html https://biospectrumindia.com/views/95/5853/crystal-ball-gazing-2015-fermenta-biotech.html Thu, 22 Jan 2015 10:51:00 +0530 In Biotechnology space where the FBL is placed, we see a positive transformation towards changing various chemical processes into enzyme mediated process. Already, there have been commercial success stories of using next generation enzymes in the synthesis of antibiotics and we expect the trend to go beyond antibiotics. With few blockbuster molecules which are prepared using an enzymatic approach, going off patent, we anticipate many companies would commit into this space. The year 2014 has been with mixed response, in some segments we have seen a very positive response but in some we have seen stiff competition. We believe competition makes one better and hones the overall organization skills. With the positive and emerging trend of "green" manufacturing practice, FBL is poised for a leadership position in the enzyme biotechnology space, by offering next generation enzyme, diversity of enzyme application and integrating key processes. Our company's focus would be overall, spanning all the areas. As FBL would be expanding in regulatory landscape for new products, the core focus would be quality and regulatory compliance across all the market segments. FBL being a pioneer in enzymatics, is committed to offer value addition and create niche space for its products and technologies. The industry so far has been responding well inspite of sheer competition from within and China. But there is a space for quality and value added services. So, the key is to strive on the quality, cost and novelty in providing overall value addition. Overall lifescience sector is expected to perform better with more new companies and technologies engaged to create value. The off patent status of few molecules is expected to drive the growth in this segment. Clinical services sector as a combination with other value added services is expected to perform better amidst challenging business environment. ]]> <![CDATA[Crystal ball Gazing 2015: Convatec]]> https://biospectrumindia.com/views/95/5840/crystal-ball-gazing-2015-convatec.html https://biospectrumindia.com/views/95/5840/crystal-ball-gazing-2015-convatec.html Thu, 22 Jan 2015 10:15:00 +0530 The year 2014 has been very favorable for Convatec and we have experienced high double digit rate growth. Currently, the market size is expanding. Acceptance of the products have increased with doctors, nurses and people. In the coming years we are planning to expand our reach by investing in home healthcare and geriatric care. In 2015, we are planning to launch few products like creams and lotions intended for hospital purposes in the market. Next year will be very exciting for the company and we are also planning to increase the number of wound clinics we have established in India. Our major focus is customer satisfaction and we aim to reach more people spread across tier-II and tier-IV. In order to keep market exciting and doubling Convatec will continue to launch new products in the market.The new government in India is showing promising progress for the biotech sector and this is a very good news for the industry. The trend is very encouraging for industries and we can see a unique drive in this government. As an industry body, our expectations from the government include-one-window clearance for companies that wish to set up units in India, simplified tax structure, encourage make in India, and also increase funding to further foster the sector. ]]> <![CDATA[Crystal ball Gazing 2015: Horizon Discovery]]> https://biospectrumindia.com/views/95/5851/crystal-ball-gazing-2015-horizon-discovery.html https://biospectrumindia.com/views/95/5851/crystal-ball-gazing-2015-horizon-discovery.html Thu, 22 Jan 2015 10:14:52 +0530 The emergence of CRISPR in 2014, an RNA-guided nuclease based gene editing technology, has revolutionized gene editing allowing anyone to try and build better research models. This year many labs started to try gene editing, and are beginning to realize not only the power of these models in their work, but also the challenges that still exist in their development. 2015 will continue to extend this trend as this exciting technology moves from hype to practical use through refinements and by combining CRISPR with other technologies such as Horizon's proprietary rAAV. Horizon, as true experts in all methods of in vitro and in vivo gene editing are providing the critical tools and services needed to support customers in in their work.2014 was a transformational year for Horizon. In March 2014, Horizon was floated on the UK Alternative Investment Market, raising £68.6 million, nearly triple the target figure. This provided us with the funds to actively pursue our goals, which were to help expand Horizon's reach to new customers, to expand our access to key intellectual property and to grow our capabilities to cover all of the stages of the drug development process. Since the IPO, Horizon has completed two M&A transactions including the combination screening services business CombinatoRx based in Cambridge, Massachusetts and the world-leading in vivo gene-editing business SAGE® Labs based in St Louis, Missouri and Boyertown, Pennsylvania. The acquisition of CombinatoRx deepened our screening capabilities, allowing us to offer high-throughput combination screening to customers so that they can identify combinations of drugs or other factors that lead to the optimal therapeutic effect with the lowest risk of side effects, while the acquisition of SAGE Labs has allowed Horizon to extend its offering to include in vivo models, critical tools for preclinical research.Horizon's goal in 2015 is to further implement its strategy to build a fully-integrated life science business company, becoming the go-to company for the provision of integrated product, service and research solutions at all stages of translational genomics and personalized medicine research from sequence to treatment. A particular focus is to develop the platforms and infrastructure to industrialize gene editing and functional genomics making it possible to increase productivity (eg cell line generation and functional data generation and analysis) by a factor of 10-100.The lifescience sector has been the strongest performing sector in the public markets for the past number of years and we expect this to continue. ]]> <![CDATA[J&J reports 2014 fourth-quarter results]]> https://biospectrumindia.com/news/95/5843/jj-reports-2014-fourth-quarter-results.html https://biospectrumindia.com/news/95/5843/jj-reports-2014-fourth-quarter-results.html Thu, 22 Jan 2015 09:51:00 +0530 Operational results increased 3.9 percent and the negative impact of currency was 4.5 percent. Domestic sales increased 7.4 percent. International sales decreased 6.7 percent, reflecting operational growth of 1.2 percent and a negative currency impact of 7.9 percent. Excluding the net impact of acquisitions and divestitures, on an operational basis, worldwide sales increased 6.7 percent, domestic sales increased 10.7 percent and international sales increased 3.6 percent. Worldwide sales for the full-year 2014 were $74.3 billion, an increase of 4.2 percent versus 2013. Operational results increased 6.1 percent and the negative impact of currency was 1.9 percent. Domestic sales increased 9.0 percent. International sales increased 0.4 percent, reflecting operational growth of 3.7 percent and a negative currency impact of 3.3 percent. Excluding the net impact of acquisitions and divestitures, on an operational basis, worldwide sales increased 8.0 percent, domestic sales increased 11.6 percent and international sales increased 5.1 percent. "2014 was a strong year for us, as we delivered solid financial results while continuing to make investments to accelerate growth for the long term. We have built significant momentum in our pharmaceutical business, are realizing the benefits of innovation, scale and breadth in our medical devices business and are continuing our market leadership with iconic brands in our consumer business," said Mr Alex Gorsky, chairman and CEO, J&J. ]]> <![CDATA[MSF supports India's patent rejection on Hep C drug]]> https://biospectrumindia.com/news/95/4286/msf-supports-indias-patent-rejection-on-hep-c-drug.html https://biospectrumindia.com/news/95/4286/msf-supports-indias-patent-rejection-on-hep-c-drug.html Wed, 21 Jan 2015 13:20:50 +0530 Last Wednesday's decision paves the way for increased access to more affordable sofosbuvir in India and other countries who choose to implement legal flexibilities available under international law to increase access to the drug. However, existing patents on sofosbuvir in South Africa could block access to the cheaper generic versions that will become available due to the ruling. The government should therefore urgently finalize the national intellectual property policy to allow South Africa to better protect access to medicines. Hepatitis C is a curable disease that affects over 185 million people and leads to nearly half a million deaths worldwide each year. As many as one million people in South Africa may be infected with hepatitis C virus (HCV). Sofosbuvir has fewer side effects, is easier for patients to take, and has higher cure rates than existing treatments. However, sofosbuvir is not yet registered or available in South Africa, and existing patent barriers could hinder the country from looking for multiple generic sources of the drug in order to get the most affordable prices. Pharmaceutical company Gilead sparked a global outcry by setting sofosbuvir's price at $1,000 (R 11, 600) per pill in the United States. The $84,000 (R 9,74, 439) price tag for a 12-week course of treatment means many US patients are excluded from receiving sofosbuvir. The UK's National Health Service have delayed sofosbuvir's introduction due to its high price of £35,000 (R 6,14,907) per 12-week course. Even in countries like Egypt with a high burden of Hepatitis C, where Gilead has offered a discount, the lowest price per course rings up at $900 (R 10, 440). Rejection of the patent in India will allow generic manufacturers that have not already signed restrictive licensing agreements with Gilead to produce sofosbuvir at much lower prices than currently available. Research conducted by Dr Andrew Hill at the University of Liverpool, for example, suggests that sofosbuvir can be profitably produced for as little as $102 (R1,182) per 12 week course. ]]> <![CDATA[Strides, Gilead unite to manufacture HIV drug]]> https://biospectrumindia.com/news/95/5364/strides-gilead-unite-to-manufacture-hiv-drug.html https://biospectrumindia.com/news/95/5364/strides-gilead-unite-to-manufacture-hiv-drug.html Wed, 21 Jan 2015 12:40:37 +0530 As part of the licensing agreement, pending USFDA approval of the Gilead product, Strides will receive a technology transfer from Gilead, enabling Strides to manufacture low-cost versions of TAF for developing countries. TAF is a novel nucleotide reverse transcriptase inhibitor that has demonstrated high antiviral efficacy at a dose 10 times lower than Gilead's Viread (tenofovir disoproxil fumarate), as well as an improved renal and bone safety profile. The license being granted to Strides extends to 112 countries, which together account for more than 30 million people living with HIV. TAF and TAF-based regimens are investigational products in the United States and have not yet been determined safe or efficacious in humans. ]]> <![CDATA[Crystal ball Gazing 2015: Avesthagen]]> https://biospectrumindia.com/views/95/5363/crystal-ball-gazing-2015-avesthagen.html https://biospectrumindia.com/views/95/5363/crystal-ball-gazing-2015-avesthagen.html Wed, 21 Jan 2015 12:38:56 +0530 Achieving predictive preventive and personalized healthcare via the convergence of food, pharma and population genetics has been the mantra of Avesthagen since a decade. We are glad to see that the biotech industry across the world are moving towards this goal in their own ways. We believe that this trend is going to continue for the next several decades. 2014 has been an eventful year for Avesthagen. We are in the process of restructuring the company, and see that as the way ahead for resurgence. We are in several important negotiations for our biosimilars, algal DHA and other bioactives for metabolic disorders, as well as for The Avestagenome. Two of our biosimilar molecules, AVDESP and AVENT, are moving to clinical trials, and three of them are ready for preclinicals. These are our immediate priorities. Given the increased urbanization in the country, the pressure on land and water resources are increasing. Our technology for Environment Adjusted Crops with increased drought and tolerance and salinity tolerance, would thus be one of the solutions to deal with this problem. Our vegetarian DHA, an omega-3-fatty acid, from an algal source, and other Functional Foods would also be moving into the market. We expect to complete the analysis of a few Parsi genome sequences. That would give us major insights into new SNPs and variations within this endogamous community. We are also in discussions with a few international organizations for collaboration on specific aspects of The Avestagenome project. There are two major related challenges that the industry currently faces. One is the tight noose of compliance and regulatory requirements that make progress debilitating. The other is the availability of funding. In both cases, the norms of the software Industry which deals with mainly services, is applied to innovative research and product development in the lifescience Industry. This makes it counterproductive, since the two industries, the required funding and the outputs, and especially the timelines are hugely very different.It is very important that the government takes steps to ease regulations and compliances, gives incentives to the innovative lifescience research to boost the industry and make us internationally competitive.In India, the sector comprises of Pharma companies making generic drugs, and Biotech/lifescience that deals with innovation and services. The pharma sector is 40-60 years old and is well established. They will continue to perform well. Biotech/lifesciences, on the other hand, is relatively new, and is still trying to find its foothold. Unless adequately supported by the government in terms of relaxing regulatory and compliance requirements, and ease of obtaining funding, their performance is likely to see meagre progress. ]]> <![CDATA[Experts deliberate on health priorities, unveil roadmap 2025]]> https://biospectrumindia.com/news/95/5361/experts-deliberate-on-health-priorities-unveil-roadmap-2025.html https://biospectrumindia.com/news/95/5361/experts-deliberate-on-health-priorities-unveil-roadmap-2025.html Wed, 21 Jan 2015 12:24:43 +0530 With the vision to help make our country a healthy India, the apex healthcare sector body NATHEALTH, released a white paper 'AAROGYA BHARAT 2025' in collaboration with Bain & Company at its 2nd annual event held in New Delhi on January 21. Speaking on the occasion Mr Shivinder Mohan Singh, president, NATHEALTH remarked, "This 'White Paper' is an effort by NATHEALTH with collaboration of Bain & Company to drive thought leadership as we move towards a healthier, 'Aarogya' India over the next decade. Total spending on healthcare is anticipated to reach about 6 percent of GDP by 2025. Private insurance is expected to grow at a compounded annual rate of about 25 percent to cover the top 25 pecent of the population, by income level. Public insurance will provide essential care to 60 percent of the population by 2025." According to the paper, 70 percent of India's population has no health insurance and is short by 2 million beds compared with the global benchmark. India requires US$ 3 Trillion in cumulative funding and has the potential to generate 15 to 20 million jobs by 2025. Besides Mr Shivender Singh, the additional secretary and DG, CGHS Department, Mr Navreet Singh Kang, chairman, Apollo Hospitals, Dr Prathap C Reddy and and Mr Anjan Bose, secretary general, NATHEALTH unveiled the white paper. The key industry association also introduced a unique initiative of an 'Ethics Pledge', a declaration by the industry leaders across diverse healthcare segments in partnership with IMA, to build a robust and transparent platform to promote ethical practices in the healthcare ecosystem. Mr Anjan Bose said, "India can adopt universal access to essential healthcare driven by private sector-led provision with the Government playing the role of primary payer and provider in remote and underserved areas. To facilitate 'Make in India' innovations, the Government can look to further incentivize domestic innovation and manufacturing. This will also have a ripple effect in terms of increased FDI and will generate employment." Recommendations: The white paper recommends the expansion of the supply of healthcare talent in critical roles, rejuvenation of AYUSH, (Ayurveda, Yoga and Naturopathy, Unani, Siddha and Homoeopathy) and encouragement of private investment in education. NATHEALTH has urged the government to increase public spending on healthcare to 2.5 percent to 3 percent of GDP, apportion a greater share of public spending to prevention, including mass screenings and primary care coverage by 2025. Additionally, the Government should focus on being a payer, not a provider and demand and support quality outcomes. A key recommendation of the White Paper is an appeal to the government to increase tax exemption on premiums of health insurance and incentivize private sector participation in medical education. Mr Karan Singh, partner, Bain & Company informed that Capex spending will grow from current levels of less than 10 precent to 15 percent of overall healthcare spending. Expanding infrastructure will lead to 1.7 million additional functional beds thus improving the density of beds from 0.9 per thousand today to 2.0 per thousand in 2025. Mr Shivinder Singh further said, "Despite evolution on multiple fronts, India still struggles with substantial issues and gaps in its healthcare system. At 1.3 percent of GDP, public spending on healthcare in India is amongst the lowest across developing countries and affects the poor and inaccessible rural areas the most." In order to develop a holistic and sustainable healthcare system, our immediate priority is to ensure that the government assigns national priority to the healthcare agenda, commits to spending more on public health and define a framework for India's health system. Additionally, the Government should enable a paradigm shift to healthy living via greater public spending on prevention Mr. Singh added. Dr Prathap C Reddy, founder president, NATHEALTH mentioned, "The sole responsibility does not lie with the government. The private players in the healthcare industry have a significant role to play to bridge the demand-supply gap and to build a healthier India. Members of NATHEALTH, with the right incentives, should aspire to invest in expanding the supply of affordable care, especially in rural areas and in Tier 2 and Tier 3 cities. Further Secretary General, NATHEALTH, Mr Bose, said "The Government could focus on the role of a payer while investing in public health and leading the provision of care in underserved areas. Additionally, it should drive policy consensus among the centre and the states to ensure that appropriate priority is given to delivering high quality healthcare. ]]> <![CDATA[Novartis selects Qualcomm Life to digitize its clinical trials]]> https://biospectrumindia.com/news/95/5142/novartis-selects-qualcomm-life-to-digitize-its-clinical-trials.html https://biospectrumindia.com/news/95/5142/novartis-selects-qualcomm-life-to-digitize-its-clinical-trials.html Wed, 21 Jan 2015 10:21:00 +0530 Qualcomm has announced that its subsidiary, Qualcomm Life, has been selected by Novartis, as a global digital health collaborator for its Trials of The Future program. Qualcomm Life's 2net Platform will serve as a global connectivity platform for collecting and aggregating medical device data during clinical trials to improve the convenience and speed of capturing study participant data and test results to ultimately gain more trial efficiencies and connected experiences for participants. The Trials of The Future program is designed to leverage healthcare technology to improve the experience of clinical trial participants and patients using Novartis' products, and provide connectivity with future products marketed by Novartis. Novartis will combine the 2net Platform, 2net Hub and 2net Mobile technologies with designated medical devices to automate the collection of vital patient data at patient's homes during clinical trials. "Novartis is a pioneer in putting technology to use in advancing pharmaceutical innovation. Standardizing on the tech-agnostic 2net Platform and accessing the robust ecosystem of integrated medical devices will provide them a great range of flexibility and scalability, ultimately accelerating their efforts to design more efficient, cost-effective clinical trials," said Mr Rick Valencia, senior vice president and general manager, Qualcomm Life. Novartis is using the 2net Platform in a recently-launched clinical study, evaluating the use of mobile devices with chronic lung disease patients. The study, which is observational in nature and does not involve any Novartis pharmaceutical product, leverages 2net Mobile-enabled smartphones and 2net Hubs to seamlessly collect and aggregate biometric data from medical devices and transmits this data to the cloud-based 2net Platform, which securely sends the data to the study coordinator. ]]> <![CDATA[What awaits the Indian biotech industry in 2015?]]> https://biospectrumindia.com/views/95/4888/what-awaits-the-indian-biotech-industry-in-2015.html https://biospectrumindia.com/views/95/4888/what-awaits-the-indian-biotech-industry-in-2015.html Wed, 21 Jan 2015 10:03:00 +0530 We expect tremendous amount of innovation to occur in the vaccine and biosimilar industry. The sector will see a host of new vaccine launches that will address public health, and also help the nation reduce the disease burden. In the vaccine sector, the big trends to watch out for are 'Make in India' molecule thrust and the maturity of R&D in India. Rotavac, the first novel vaccine not only from India but also from the developing world, a unique social innovation project, an Indo-US bilateral program under the aegis of Department of Biotechnology (DBT), the Society for Applied Studies, and Bharat Biotech spearheaded by Dr MK Bhan, Dr VijayRaghavan and Dr TS Rao, is a giant realization of the 'Make in India' vision. Rotavac brought together the experience and expertise of Indian and international researchers as well as the public and private sectors. The vaccine is expected to roll out in the market in 2015. The development of Typhoid Conjugate vaccine indigenously by Bharat Biotech is also another shining example of 'Make in India 'vision. The maturity of India's R&D program is yet another significant milestone, reflected with the publication of articles on Rotavac by the world's most respected and widely acknowledged medical journal Lancet. One of the biggest challenges that Indian sector have to counter is the dynamic policy change China has made to fuel the growth of vaccine and biosimilar sector in their country. These changes will impact the Indian industry competitiveness in the global UNICEF and private markets. The Chinese government, since the last 5 years, has closed many public sector units and many have been privatized to ensure that they meet the new GMP regime. With the deadline to meet the GMP norms closing on December 31, many of the Chinese companies have upgraded their facilities and those which do not meet those standards will be shut down starting January 1, 2015. The closure of PSUs in China has also led to the shortage of Chicken Pox vaccine in the markets. To push the sector forward, the Chinese government helps their industry by subsidizing the Capex (capital expenditure) in the sector to enable the domestic companies meet the GMP standards which constantly changes. The new policy push will also make Chinese vaccine and biosimilar companies become highly competitive in the UNICEF and other private markets in the world. Beginning 2015, the cost of Chinese vaccine is also expected to go up as a result of their creation of world standard facilities with huge investments. In the biosimilar sector we will see China and Korea emerge as the top nations. These two nations put together, will have the largest biosimilar projects in the world. Their investments to create global standard facilities meeting the GMP will create a significant impact in the worldwide market. They will also meet majority of the global requirements.The Indian companies hopes the government will continue to extend its support and also formulate fresh policy changes to help them remain competitive in the global markets as well as stimulate 'Make in India' vision. Moving forward it is important for Indian companies to maintain consistent global standards in its R&D and manufacturing programs to remain globally competitive. As Indian companies upgrade their facilities to meet global standards, there will be change in pricing strategies in the Indian products as well. As a company, we persist to maintain consistent growth, however, the year 2014 has been a year of moderate growth, and this is due to delay in announcing the launch of National Immunization Programs and also a trivial delay in the launch of our new vaccine. We are very upbeat and we hope 2015 will be a growth acceleration year as our new vaccines will begin to contribute to our revenues in a large manner.In the coming year, our biggest dream is to offer the world Rotavac, the first molecule developed in India and from the developing world under the PPP program, which is ready for launch. We also hope to play a significant role to make India typhoid-free nation. Another significant aspect that will contribute to our business growth curve in a big way is the roll out of National Immunization Program, and the inclusion of Rotavac, Measles & Rubella and JE for adults in the National Immunization Pilot program in the country by the government of India. We will continue to invest in R&D of new molecules to solve public health problems of emerging countries with a focus on neglected diseases.Currently, there is a lot of inconsistency in the market. We expect far more stability in the market post the budget announcement in 2015. As said earlier, we expect significant acceleration in development of indigenous molecule.The first big step in accelerating the growth of domestic vaccine industry is the inclusion of Rotavac, JE for adults, and Measles & Rubella in the National immunization program pilot project that will roll out soon in many Indian states. Rotavac inclusion in the National Immunization Pilot project is a big push to the sector that represents the successful research and development of a novel vaccine from the developing world with global standards. Rotavac is a very important scientific breakthrough from India against rotavirus infections, the most severe and lethal cause of childhood diarrhea, responsible for approximately 100,000 deaths of small children in India each year. The fully indigenous vaccine was developed through a unique social innovation partnership that brought together the experience and expertise of Indian and international researchers as well as the public and private sectors. Rotavac is also one of the largest efficacy trials conducted ever in India. The 'Swach Bharat Abhiyaan' kick started by the Prime Minister of India is a positive sign for the industry too as vaccine becomes an integral part of the strategy to make India a healthy nation besides advocating the practice of clean and hygienic environment. We also hope the PPP in the sector will fuel tremendous growth in the domestic industry in the coming years as we set to accomplish 'Make in India' dream. ]]> <![CDATA[ Urgent need to check epidemic of noncommunicable diseases: WHO]]> https://biospectrumindia.com/news/95/5086/-urgent-need-to-check-epidemic-of-noncommunicable-diseases-who.html https://biospectrumindia.com/news/95/5086/-urgent-need-to-check-epidemic-of-noncommunicable-diseases-who.html Wed, 21 Jan 2015 08:30:00 +0530 "This number is expected to grow larger if we do not act now to arrest this epidemic," said Dr Poonam Khetrapal Singh, WHO, deputy regional director, South-East Asia. Heart diseases, cancer, diabetes, and respiratory diseases account for most of the deaths and disease due to noncommunicable diseases. While noncommunicable diseases are a global public health challenge, nearly three quarters of the deaths occur in low- and middle-income countries. "The problem is growing, particularly in the South-East Asia Region, where two out of three deaths are caused by noncommunicable diseases. Nearly half of deaths due to noncommunicable diseases occur in the 30 to 70 year age group. Today, a 30 year old person living in the WHO South-East Asia Region has 25 percent chances of dying from one of the four main noncommunicable diseases before his or her 70th birthday. This probability is much less at 15 percent for an individual in the Americas," Dr Singh added. Most of the premature NCD deaths are preventable. Promoting simple lifestyle changes and diet modifications can prevent noncommunicable diseases. "These recommendations include 'best buys' or cost-effective, high-impact interventions such as banning all forms of tobacco and alcohol advertising, reducing salt consumption, replacing trans fats with polyunsaturated fats, promoting and protecting breastfeeding, early detection and treatment of high blood pressure and preventing cervical cancer through periodic screening," explained Dr Singh. The global WHO report on NCD warns that the death toll due to noncommunicable diseases would mount to 52 million by the year 2030 from 38 million in 2012. Dr Poonam urged that the report highlights the need to act immediately. "All governments must commit and set national NCD targets this year and implement policy and cost-effective interventions for prevention and control of major noncommunicable diseases. High rates of death and disease, particularly in low- and middle-income countries, is a reflection of inadequate investment in cost-effective NCD interventions. WHO recommends that all countries implement the 'best buys' interventions," she opined. Noncommunicable diseases impede efforts to alleviate poverty and advance sustainable development. Dr Singh said, "When people fall sick and die in the prime of their lives, productivity suffers. Besides, the cost of treating diseases can be devastating - both to the individual and to the country's health system. It is time that governments partner with the private sector, NGOs, media and civil society, to reduce the NCD burden with appropriate policies and measures to achieve the global voluntary NCD targets by 2025." Global voluntary noncommunicable disease targets by 2025: Target 1A 25 percent relative reduction in risk of premature mortality from cardiovascular diseases, cancer, diabetes, chronic respiratory diseases Target 2At least 10 percent relative reduction in the harmful use of alcohol, as appropriate within the national context Target 3A 10 percent relative reduction in prevalence of insufficient physical activity Target 4A 30 percent relative reduction in mean population intake of salt/sodium Target 5A 30 percent relative reduction in prevalence of current tobacco use in persons aged 15+ years Target 6A 25 percent relative reduction in the prevalence of raised blood pressure or contain the prevalence of raised blood pressure, according to national circumstances Target 7Halt the rise in diabetes and obesity Target 8At least 50 percent of eligible people receive drug therapy and counselling (including glycaemic control) to prevent heart attacks and strokes Target 9An 80 percent availability of the affordable basic technologies and essential medicines, including generics, required to treat major NCD in both public and private facilities WHO South East Asia Region has an additional target to reduce household air pollution by reducing the use of solid fuels for cooking by 50 percent. ]]> <![CDATA[Merial receives European approval for chewable NexGard Spectra]]> https://biospectrumindia.com/news/95/4933/merial-receives-european-approval-for-chewable-nexgard-spectra.html https://biospectrumindia.com/news/95/4933/merial-receives-european-approval-for-chewable-nexgard-spectra.html Tue, 20 Jan 2015 14:10:11 +0530 Sanofi and its animal health company Merial announced that the European Commission has approved NexGard Spectra (afoxolaner and milbemycin oxime), a soft, beef-flavored chew for dogs that provides a broad spectrum of internal and external parasite control in one monthly dose. NexGard Spectra, a prescription-only product, has been approved in Europe for the treatment of flea and tick infestations, the prevention of heartworm disease and/or the treatment of intestinal worms (roundworms, hookworms and whipworm). "The European approval comes less than a year after the highly successful launch of NexGard, the first monthly beef-flavored chew for the treatment of flea and tick infestations in dogs. NexGard Spectra offers the same tasty and easy to use product, but for both external and internal parasites in dogs. We are proud to bring yet another option to veterinarians in flea and tick and heartworm control. NexGard Spectra is another example of Merial's commitment to deliver innovative products that improve the health and wellbeing of animals," said Mr Carsten Hellmann, Merial CEO and Sanofi executive VP. NexGard Spectra will be available in five different chew sizes for dogs of different weights and is a novel combination of two active ingredients. Afoxolaner is a new generation ectoparasiticide, killing fleas and ticks on the skin of dogs before they lay eggs. Milbemycin oxime acts as an endoparasiticide, killing parasites like heartworms, roundworms, hookworms, and whipworms that live inside the body of dogs. NexGard Spectra adds to the company's parasiticide portfolio for pets and offers a new option for veterinarians and pet owners. NexGard Spectra will be offered in Europe through veterinary prescription only. Studies showed that the highly palatable NexGard Spectra effectively treated flea and tick infestations in dogs for up to 30 days after treatment, while killing intestinal worms (roundworms, hookworms and whipworm) and preventing heartworm infection. ]]> <![CDATA[Novartis, Qualcomm erect joint investment company ]]> https://biospectrumindia.com/news/95/5988/novartis-qualcomm-erect-joint-investment-company-.html https://biospectrumindia.com/news/95/5988/novartis-qualcomm-erect-joint-investment-company-.html Tue, 20 Jan 2015 13:17:04 +0530 Novartis announced the plans to establish a joint investment company with Qualcomm Ventures, the investment arm of Qualcomm Incorporated, The joint investment company will target early stage companies who offer technologies, products or services that 'go beyond the pill' to benefit physicians and patients. "By working with Qualcomm Ventures, Novartis sees the opportunity to take a greater leadership role in introducing new mobile or digital technologies that have the potential to change the practice of medicine and bring more breakthroughs with real benefits to patients and society," said Mr David Epstein, division head, Novartis Pharmaceuticals. "We are excited by the potential of digital medicines to further enhance our mission of the right drug for the right patient at the right time helping people live longer with a better quality of life giving more time to do the things that matter to them." Digital and mobile technologies are expected to make a significant difference in the pharmaceutical industry. New technologies are emerging such as telephone enabled devices, mobile applications, wearable devices, and technologies for big and small data to enable delivery of the right medicine to the right patients and more robust pharmaco-economic analyses. ]]> <![CDATA[Will rare diseases remain orphan? ]]> https://biospectrumindia.com/features/95/4890/will-rare-diseases-remain-orphan-.html https://biospectrumindia.com/features/95/4890/will-rare-diseases-remain-orphan-.html Tue, 20 Jan 2015 13:01:06 +0530 Despite medical advancements, rare diseases are still a common occurence in India. Rare Diseases India, an organization that focuses on providing scientific data concerning rare diseases and disorders, estimates that around 72,611,605 people in India are suffering from a rare disease. About 6,000 to 8,000 rare diseases, mostly genetic in nature have been identified across the world and only around 500 of them have known therapies. India is the second highly populated nation in the world and hence even the rarest of diseases will have many patients seeking treatment. Considering the fact that the present government's priority is to address demanding health issues, its attention to the nebulous rare diseases area, barring a handful of rare diseases, has been non-existent. The need for orphan treatments in India is huge and with little in place so far, India represents a lucrative market. Most of these disorders are genetic in nature and timely treatment can assure the victims of a healthy life. The disorders, once rare, are now affecting larger populations, with one in 5,000 suffering from a rare genetic disorder. Currently, drug developers in India are receiving no formal incentives from the government. Hence, orphan drugs need to be imported, which in turn makes them highly unaffordable. Lack of a policy or a legal framework in these countries is deterring the development of these drugs and thus many rare disease patients die. The increasing number of people falling prey to these diseases has reiterated the need for a sound legal policy and framework to support drug development for diseases. In an exclusive interview with BioSpectrum, Mr Sandeep Sahney, head-intercontinental, Genzyme said, "A major challenge in bringing new orphan drugs to the market is the ability to garner a share of voice at a societal level for the 'few' patients. The other challenge is creating support from governments and lack of an appropriate policy to create a platform to address these diseases." For long, the Orphan Drug Act (ODA) has been considered a key game changer that can alter the dynamics of orphan drugs and rare diseases in any country. The ODA, formulated by the US in 1983 can be rightly termed as the catalyst that fostered the development of these drugs. Under this Act, orphan drugs enjoy many regulatory and commercial incentives such as tax credits, grants, waived FDA fees, reduced timelines for clinical development and higher probability of regulatory approval, coupled with commercial drivers such as premium pricing, faster uptake, lower marketing costs, and longer market exclusivity. Only five Asian countries have implemented this Act -Australia, Japan, Korea, Singapore, and Korea. However, countries with a huge population like China and India do not have a policy that can attract global players to show corporate interest in this area. If the governments in these countries do not formulate a policy to address these rare disorders, orphan diseases will unfortunately remain orphan. "In the case of Orphan Drug Development," explained Dr AKS Bhujanga Rao, president, technical/R&D and director, Natco Pharmaceuticals, "more than the medical advancements, it is the government's initiative, the concerted effort by the medical and pharmaceutical companies, government, academia, and research organizations that can create a difference. The government act can trigger tremendous response for orphan drugs given their high demand and market value." Need for legal framework Since the introduction of ODA in a few countries across the globe, nearly 1,100 drugs and biological products have been designated as orphan products and many have received approvals. According to statistics from the FDA, from the time of authorization of the Orphan Drug Act in 1983 in the US, until end 2013, Orphan Drug designation has been awarded to 2,843 compounds, and of these, there have been 442 approvals for Orphan indications. Speaking to BioSpectrum, Dr Meenakshi Bhat, consultant in clinical genetics at the Center for Human Genetics in India accentuated, "India never had enough awareness and organized approach towards rare diseases. We have the talent and the money, however, it is not coordinated into actual deliverables. We have the largest biotech companies in India. Many are interested in investing in rare disorders R&D. But the moment they think in terms of marketing and business, which is where the hesitancy is." Stating that the Orphan Drug Act will help in easing logistics for orphan drug imports as well as help in bringing new drugs into the market, Mr HarshaKarur Rajasimha, co-founder, Organization for Rare Diseases India (ORDI) stated, "Target pools are very high in India as compared to the US where the number of patients is almost three times smaller. Due to the lack of any legal framework or policy that encourages the manufacturing of these drugs in India, we import them." Orphan drug development provides ample opportunities for research and development and reducing the disease burden of the society, thus improving healthcare of the country at large. However, without a proper system and guidance from regulatory bodies or pharmacological associations, it is challenging for a pharmaceutical company to invest in the development of orphan molecules from scratch. It is important to integrate orphan drugs into the healthcare system of India and allocate adequate finances to aid reimbursement, as most of the drugs are very costly and many patients cannot afford them. Mr Ketan Patel, chairman and managing director, Troikaa pharmaceuticals, highlighted, "Orphan drugs have to be kept out of the ambit of price control for the simple reason that economics of manufacturing of such products demands so. Besides, no company will be motivated to spend on developing an Orphan Drug, which, after a tedious development effort, will be brought under price control subsequent to its launch." Challenges in Orphan Drug Space There are many challenges faced in the orphan drug space. There is little known about the natural history of rare diseases and hence diagnosis and development of a drug is a huge challenge. There are over 7000 rare diseases which occur over a broad spectrum of illnesses that have little or nothing in common with each other. The disease affects a very small population of the society and mostly young children and hence structuring clinical trials is very difficult. "It is extremely challenging to find patients in required numbers to participate in clinical trials," observed Mr Sahney, "This makes recruitment of volunteers really tough. While the number of patients required for CT may be small, the costs of running the trials are high since these patients are spread far and wide. Additionally, there are challenges on reimbursement at 'right' pricing that surface across potential markets. Hence, without an ACT that addresses these challenges, it is impossible to spur the innovation of orphan drugs in India." Many a times the disease is localized to one country and is not prevalent in other countries. Hence, without adequate financial assistance by the government, pharma companies will reap very little or no profits through their orphan business. In such circumstances, scientists, clinical practitioners, pharmaceutical companies, and most importantly non-governmental organizations including disease support groups should contribute and pool reBioSpecial sources, however small, to highlight the general issues of rare diseases. Mr Sahney said, "At present, the provisions to encourage Research & Development in rare diseases range from 'no provisions' to very 'limited provisions'. These are essential for incentivizing both R&D and reimbursement pathways for drugs for orphan diseases." Looming patent cliff- An advantage? As reported by Total Biopharma, it is estimated that biological patents worth $67 billion is due to expire by 2020. With many blockbuster drugs losing protection, big pharma companies have now gravitated towards specialty drugs, orphan drugs, and the biologics market. If proper legislation and framework is enacted, orphan businesses may swell in this patent pool and thus can eventually treat many potential rare disorders. ]]> <![CDATA[Medtech Industry on the right path? ]]> https://biospectrumindia.com/features/95/4779/medtech-industry-on-the-right-path-.html https://biospectrumindia.com/features/95/4779/medtech-industry-on-the-right-path-.html Tue, 20 Jan 2015 12:29:11 +0530 India is currently growing as a key market for medical devices and diagnostics. According to reports, emerging markets will play an essential role in the global medical device industry and India as an emerging market will continue to be important for the global Medtech industry. Current scenario: the untapped market? India has seen growth in terms of the increase of hospitals as well as the medical devices market. According to a white paper by EEPC (Engineering Export Promotion Council) India , Medical device Industry in India, the Indian Medical industry is currently the fourth largest market in Asia and valued at `30, 000 crore. It is expected to grow at a Compounded Annual growth Rate (CAGR) of 15 percent. The Indian medical device is currently fragmented with close to 1,000 domestic firms primarily manufacturing low tech products, whereas importers dominate the costly and high end medical equipment with extensive service networks. However, domestic companies seem to be transitioning from producing devices in the low technology segment to the medium technology segment. According to the CII-BCG report, currently the sector is import driven with more than 70 percent of the devices are exported and the sector remains highly underpenetrated contributing 7-8 percent of the healthcare spends compared to pharmaceuticals at 18 percent. The challenges: Perhaps the biggest drawback of the industry is the lack of recognition as a separate sector. It is currently included in the Drugs and Cosmetics Act 1940 and comes under pharmaceuticals. The passage of the drugs and amendments bill might be for the better. Earlier this year, AdvaMed, the medical devices association had written a letter to the health minister asking for early passage of the Drugs and Cosmetics (Amendment) Bill 2013. A study titled "Access to Healthcare: Indian Perspective", released by The Associated Chambers of Commerce and Industry of India (Assocham) highlighted that India's medical device industry is facing severe challenges because of inadequate quality standards, coupled with huge reliance on imports, time delays, and other related hassles. This is causing a major hindrance. "Unfavourable Duty structure for imports and exports is another significant impediment in the growth of domestic medical devices' industry as higher import duties for raw materials than finished goods has established an 'import-export anomaly' whereby devices manufactured in India become expensive owing to high raw material costs making them uncompetitive against low priced Chinese goods," noted the study. "Besides, unlike China, our country does not provide any incentive on setting up medical device production bases to encourage medical device manufacturing, as such significant steps to overcome these anomalies are imperative to boost the domestic medical device industry thereby reducing our high dependence on exports," said Mr DS Rawat, secretary general, ASSOCHAM while releasing the findings of the chamber's study. "There is an urgent need for a single window clearance system to spur growth in new product development as the limitation of medical devices, falling under preview of the Drugs and Cosmetics Act, 1940 has been a major deterrent in the medical devices' sector growth," said Mr Rawat. "Low research and development (R&D) spends, lack of innovation and promotion including low medical device funding from Department of Science and Technology (DST) or the Department of Biotechnology (DBT), inadequate quality standards and others are significant challenges faced by the industry." Further, the CII - BCG report states that the industry is faced with significant lack of clarity in terms of regulation and predictable access to the market. This has limited investments into the market which in turn has led to lower investments in building up the component ecosystem and the technology skills base to support it. Without a vibrant component manufacturing system, domestic capabilities in innovation and manufacturing are not built, leaving it to the critical enablers to address the market not being in place. This leads to fewer market appropriate products being introduced as the local capability does not exist and therefore, a reliance on imported products. As imported products typically address a small part of the market, they have a lower relevance in the government's agenda and hence, a limited focus on clear and tangible policy and regulation which can shape the core of the industry. Roadmap to $50 billion industry In order for India to become a significant force in the medical technology industry, the country has to revise its policies and all the stakeholders should come together on the same page to foster the growth of the industry. It should be excluded from the Drugs and Cosmetics Act and be recognized as a separate sector. "We need relevant regulation, a proper system that enables and rewards innovation, streamlining of the process to invest in manufacturing infrastructure and investment in training to produce skilled manpower," said industry observers. There is a need for review of policies through inter-minister coordination for providing appropriate fiscal and support environment. This will help manufacturing to thrive and consistency in its implementation over a 5-10 year time frame. Also we should review FDI policy which allows 100 percent equity to set up manufacturing units. There needs to be stipulation to ensure at least 60 percent of the turnover would be from manufacturing operations in India, suggested EEPC in its white paper. Also, infrastructure would be needed for establishment of regional or zonal specialised test labs to provide low cost external testing by accredited labs. CII along with Boston Consulting Group (BCG) in the vision document, entitled 'Revitalising Manufacturing and Innovation to realise the $50 billion Potential' proposes that the regulatory reforms need to be accompanied by appropriate reimbursement policies. Price controls serve as a major deterrent to stimulating innovation as research based companies are unable to generate a fair return on their investments. At extremely low price points, companies are not able to import their products into India, thereby denying patients access to the latest lifesaving technologies. The industry is nascent, accounting for less than 8 percent of the total healthcare spending in India. To continue to attract investments, this nascent industry which has long gestation periods should be allowed to let market forces regulate prices and should not be clubbed with the pharmaceutical industry for price control. Also, what is required is a unified regulatory body that can approve bringing new products to the market quickly. ]]> <![CDATA[Novo Nordisk's Ryzodeg now available in India]]> https://biospectrumindia.com/news/95/8394/novo-nordisks-ryzodeg-now-available-in-india.html https://biospectrumindia.com/news/95/8394/novo-nordisks-ryzodeg-now-available-in-india.html Tue, 20 Jan 2015 12:05:00 +0530 Novo Nordisk has launched it's combination diabetic drug Ryzodeg for people with type II diabetes in India. It is available at a price of Rs 1,595 for 300 units. The product is a combination of two distinct insulin analogues (insulin degludec and insulin as part in the ratio of 70 percent and 30 percent). "India has close to 65.1 million people with diabetes standing second in the world map. We are extremely pleased to have introduced Ryzodeg, reinforcing our commitment to provide best of healthcare solutions for the use of doctors in India," said Mr Mads Bo Larsen, Novo Nordisk corporate VP for business Area Africa, Gulf, and India. As Ryzodeg is a combination product it requires fewer daily injections than administering basal and mealtime insulin in separate injections. "For more than 90 years, Novo Nordisk has been leading the fight against diabetes by developing the most innovative products based on patient needs. The launch of Ryzodeg builds on this heritage as it is an innovative product that will give the health care professional a better way to manage the condition," said Novo Nordisk India, MD Mr Melvin Oscar D'souza. The drug has also been approved for marketing in Aruba, Brazil, Chile, Costa Rica, El Salvador, EU, Hong Kong, Iceland, Israel, Japan, Kazakhstan, Macedonia, Mexico, Norway, Russia, South Korea, and Switzerland. ]]> <![CDATA[USDA deregulates Monsanto's next-gen weed control trait technology]]> https://biospectrumindia.com/news/95/3162/usda-deregulates-monsantos-next-gen-weed-control-trait-technology.html https://biospectrumindia.com/news/95/3162/usda-deregulates-monsantos-next-gen-weed-control-trait-technology.html Mon, 19 Jan 2015 13:31:12 +0530 USDA indicated that its decision will be published in the Federal Register in the near future. These weed management solutions will provide farmers with more consistent, flexible control of tough-to-manage broadleaf weeds. "This announcement marks an important milestone for farmers around the world," said Dr Robb Fraley, Monsanto's CTO, "Weeds represent a key pest to agriculture operations around the world and limit crops of much-needed nutrients, sunlight and access to available water resources. We're excited to provide additional tools that can help improve efficiencies on farm and support farmers in bringing more food to harvest for consumers." ]]> <![CDATA[Piramal expands manufacturing capacity by $20 Mn]]> https://biospectrumindia.com/news/95/3319/piramal-expands-manufacturing-capacity-by-20-mn.html https://biospectrumindia.com/news/95/3319/piramal-expands-manufacturing-capacity-by-20-mn.html Mon, 19 Jan 2015 13:30:12 +0530 In addition to investing $40M in new equipment and technologies, it is also augmenting related infrastructure. Piramal Enterprises' Pharma Solution division, a global leader in contract development and manufacturing (CDMO), was a big winner in the recent CMO Leadership Awards, securing four awards in three key categories: quality, reliability, & regulatory. Mr Vivek Sharma, CEO, Piramal Pharma Solutions, said, "We are delighted to receive this prestigious award and to be recognized in multiple areas and categories. The award serves as a validation of our efforts to keep the customer as the focal point, while emphasizing on project ownership, time delivery and commitment towards quality. This recognition from our clients will further motivate our team as we drive towards becoming the 'partner of choice'. Receiving these awards also showcases our company values of entrepreneurship, expertise and trusteeship." Respondents from big pharma, mid-sized and specialty pharma, and emerging pharma, voted Piramal to be amongst the top 10 percent in these categories. The CMO Leadership Awards by Lifescience Leader magazine is based on industry leading research conducted by Nice Insight. ]]> <![CDATA[Roche acquires Trophos]]> https://biospectrumindia.com/news/95/4379/roche-acquires-trophos.html https://biospectrumindia.com/news/95/4379/roche-acquires-trophos.html Mon, 19 Jan 2015 12:14:01 +0530 Roche has announced that it has agreed to acquire Trophos, a biotechnology company. Trophos's proprietary screening platform generated olesoxime (TRO19622), which is being developed for spinal muscular atrophy (SMA) - a rare and debilitating genetic neuromuscular disease that is most commonly diagnosed in children. Results from a pivotal phase II clinical trial with olesoxime in SMA showed a beneficial effect on the maintenance of neuromuscular function in individuals with Type II and non-ambulatory Type III SMA, as well as a reduction in medical complications associated with disease. "This acquisition highlights Roche's commitment to developing medicines for SMA , a serious disease with no effective treatment. We will build on the work done by Trophos and the French Muscular Dystrophy Association to advance the development of olesoxime and to bring it to people who live with this devastating condition as quickly as possible," said Dr Sandra Horning, chief medical officer and head of Global Product Development at Roche. Under the terms of the agreement, Trophos's shareholders will receive an upfront cash payment of $138 million (EUR 120 million), plus additional contingent payments of up to $404 million (EUR 350 million) based on achievement of certain predetermined milestones. "SMA is a grievous disease with a huge impact on the daily life of patients and their families, who are currently left only with supportive care. We are proud to see the development of this medicine evolving, with the ultimate goal of a potential first medicine for SMA. This is a tremendous recognition of the work done by Trophos's teams and supporters over the past 16 years," said Ms Christine Placet, CEO, Trophos. ]]> <![CDATA[Denmark's pharma market to decline to $3 billion by 2020]]> https://biospectrumindia.com/news/95/5728/denmarks-pharma-market-to-decline-to-3-billion-by-2020.html https://biospectrumindia.com/news/95/5728/denmarks-pharma-market-to-decline-to-3-billion-by-2020.html Sun, 18 Jan 2015 10:16:00 +0530 Price-cap agreements between the Danish Ministry of Health and the Danish Association of Pharmaceutical Industry have existed since 2008 and continue to limit pharmaceutical market growth as the government aims to keep drug prices down. This is further exacerbated by the 25% value added tax on pharmaceutical products, which is high compared to other EU countries, restricted sales of over-the-counter medicines and a costly labor force. However, Mr Joshua Owide, GlobalData's director of healthcare industry dynamics, says that there are a number of favorable conditions for the future Danish pharmaceutical market, which will be sustained by increasing demand for medicine and higher healthcare expenditure, as well as government healthcare reforms. Mr Owide explains: "Denmark's corporate taxes are to be gradually reduced to 22% by 2016 and the country does not levy capital duty, share transfer duty or wealth taxes. This benign tax environment could encourage pharmaceutical companies to set up business in Denmark. "Furthermore, the registration of a pharmaceutical product under the national procedure in Denmark takes an average of six to 12 months. This is less than the average time taken by regulatory authorities in the US and EU, which is currently 322 days and 366 days, respectively." He further adds that pharmaceuticals are one of Denmark's largest export goods. In 2013, the country exported $12.1 billion worth of pharmaceutical products, accounting for almost 11.4% of Danish exports. ]]> <![CDATA[CDC invests $48 million in Narayana Health]]> https://biospectrumindia.com/news/95/7463/cdc-invests-48-million-in-narayana-health.html https://biospectrumindia.com/news/95/7463/cdc-invests-48-million-in-narayana-health.html Sat, 17 Jan 2015 12:30:00 +0530 CDC Group, the UK's development finance institution has announced a $48 million investment in Narayana Hrudayalaya Hospitals ("NH"). According to Mr Srini Nagarajan, CDC's Head of South-Asia said, "CDC aims to invest in businesses that create jobs and provide services and economic opportunity in poorer regions of India. Narayana Health's commitment to extend healthcare to the low income states of India and to reduce the cost of that care made it an ideal partner.Our long-term capital and strategic support can help Narayana Health build on the success that it has had in using innovation and its scale to deliver world-class healthcare standards to its lower and middle-income patients. The company leads the low-cost healthcare market in India with a mission to continually drive down the cost of care. Around half of its patients receive financial support to receive treatment, either from NH themselves or through government schemes. It is this development impact, along with significant expected job growth, that makes NH such a compelling case for CDC's investment." Narayana Health has set its an ambitious growth plan, building on the 60 percent increase in beds it has delivered in the last 2 years. The healthcare provider expects to create at least an additional 8,000 jobs. It also plans to expand affordable treatment in Eastern, Central and Western India. Dr Devi Shetty, NH's founder and chairman said, "Narayana Health wants to transform the way healthcare is delivered across the world and CDC has the right approach towards addressing social issues in developing countries. We partnered with CDC because they are interested in long-term societal transformation and this objective is closely aligned with our goal." The company also operates one of the world's largest telemedicine networks with 150 telemedicine centres including 50 in Africa. This system allows remote health facilities outside of main hospitals to seek advice from consultants at Narayana Health free-of-charge. NH has formally signed up to the UK's Department for International Development-supported SHE initiative (Safety, Health, Education & Employment for Girls and Women) to deliver vocational training in Healthcare to unemployed youths from rural India in association with Healthcare Sector Skilled council (NSDC). ]]> <![CDATA[Sanofi, Boehringer collaborate to manufacture biologics]]> https://biospectrumindia.com/news/95/4131/sanofi-boehringer-collaborate-to-manufacture-biologics.html https://biospectrumindia.com/news/95/4131/sanofi-boehringer-collaborate-to-manufacture-biologics.html Sat, 17 Jan 2015 11:49:00 +0530 The financial terms of the deal were not disclosed. "We are looking forward to this collaboration with Sanofi. This agreement reflects the strategy of Boehringer Ingelheim to be dedicated and committed to the manufacturing of highly innovative new biologic entities," said Dr Uwe BÃ¼cheler, corporate SVP, Boehringer Ingelheim Biopharmaceuticals. Today, 72 percent of Sanofi's R&D projects are in biologics, nearly half of which are monoclonal antibodies (mAbs). Under the terms of the agreement, Sanofi will have access to Boehringer Ingelheim's capabilities in Biberach an der Riss, Germany, to transfer and manufacture therapeutic mAbs. Initial product transfers will begin in early 2015. "Boehringer Ingelheim is a highly capable and experienced partner to complement our continued alliance with Regeneron and the investments we are making in building our own internal capabilities as we prepare for a wave of potential new product launches in the coming years," said Mr Wolfram Carius, SVP, Biologics, Sanofi. "This collaboration reinforces Sanofi's commitment to our strong biologics pipeline and will enable us to take the necessary steps to provide access to high quality therapeutic monoclonal antibodies to meet the needs of patients." ]]> <![CDATA[Gilead denied patent for hepatitis C drug in India ]]> https://biospectrumindia.com/news/95/6077/gilead-denied-patent-for-hepatitis-c-drug-in-india-.html https://biospectrumindia.com/news/95/6077/gilead-denied-patent-for-hepatitis-c-drug-in-india-.html Sat, 17 Jan 2015 10:00:00 +0530 The oral drug, which first received regulatory approval in the US in November 2013, and has been priced by Gilead at $84,000 for a treatment course, or $1,000 per pill in the US, has caused a worldwide debate on the pricing of patented medicines. A study from Liverpool University showed that sofosbuvir could be produced for as little as $101 for a three-month treatment course. Challenges to some of the most important patent applications on sofosbuvir (a 'patent opposition' - a form of citizen review allowed in many countries) were filed in India by the Initiative for Medicines, Access & Knowledge (I-MAK) and the Delhi Network of Positive People (DNP+) in November 2013 and March 2014. "The move to reject Gilead's patent application really opens up the playing field, so we hope to now see many other generic companies starting to produce more affordable versions of this drug. The bottom line here is that India's patent law doesn't give monopolies for old science, for compounds that are already in the public domain. Gilead's strategy of charging as much as US $84,000 per treatment for a drug that is predicted to be simple and cheap to produce, and is now un-patentable in India, has been exposed for what it is - seeking to squeeze as much profit out of the sick as possible," said Mr Tahir Amin, lawyer and director of the Initiative for Medicines, Access & Knowledge (I-MAK). Gilead has signed voluntary licence agreements with multiple generic producers in India, but these agreements impose many restrictions, including which countries can access the drugs produced under these licences, as well as invasive restrictions on medical providers and patients with respect to distribution and use of the drug. With the patent being denied, other companies that have not signed the licence are now free to produce. Entry by additional generic manufacturers should increase the open competition needed to bring prices down dramatically, especially in those countries that have been excluded from the voluntary licence agreement, and thereby increase access to the medicine. "This is a happy day for the millions of people who urgently need hepatitis C treatment across the globe. People with hepatitis C everywhere should be able to have access to this treatment, but millions of our friends in middle-income countries have been left out in the cold by Gilead. This decision provides hope that people in countries that have been excluded from Gilead's licensing deals will be able to access low-cost generic versions of sofosbuvir," opined Mr Vikas Ahuja, Delhi Network of Positive People (DNP+). ]]> <![CDATA[ICMR calls for applications for transfer of human biological material]]> https://biospectrumindia.com/news/95/8084/icmr-calls-for-applications-for-transfer-of-human-biological-material.html https://biospectrumindia.com/news/95/8084/icmr-calls-for-applications-for-transfer-of-human-biological-material.html Fri, 16 Jan 2015 12:50:00 +0530 In a continuous process of allowing the transfer of biological materials for research purposes, the ICMR will process the applications four times in a year. Deadlines for submission of applications would be January 31; April 30; July 31 and October 31 of each calendar year. As per the guidelines issued by the ministry of health and family welfare vide dated November 19, 1997, a committee has been constituted to consider the cases related to transfer of human biological material for commercial purposes and/or the evaluation of cases involving transfer of infectious biological material/ human biological waste material/ any other cases for commercial purposes from foreign research centers to Indian diagnostic laboratories/R&D centers or vice versa for analysis. Besides a copy of the duly signed Material Transfer Agreement (MTA), the concerned organizations would have to submit a copy of the Institutional/Independent Ethics Committee (IEC) clearance. Among the other documents to be submitted are a copy of the import certificate as issued by the relevant foreign regulatory authority to the foreign laboratory receiving the Indian biological material (wherein export is concerned); the Memorandum of Understanding signed between Indian applicant and international agency defining the commercial benefits to each Party; copy of the details of the Intellectual Property Rights (if any) owned in terms of patents, copyright or an MoU/agreement signed by any of the Parties on biological/genetic material being transferred for commercial purposes. In addition to it, the interested firms would have to present a copy of safety or operations manual being followed/adopted as safety procedures by your laboratory for the workers involved in activities involving possible exposure to pathogens through blood or other body fluids; copy each of the disposal plan and necessary State pollution Control Board clearance (for disposal of biohazardous, potentially infectious leftover samples);copy of contract/agreement with the disposal agency that the hazardous left over bio-material will be collected, treated and disposed off as per current national regulations. Also, a duly valid copy of DCGI approval issued to study centre for conducting Bioavailability/ Bioequivalence/ Pharmacokinetic analysis and valid copy of approval for providing services under relevant discipline such as diagnostics/ physical - chemical studies/toxicity studies /medical / biological testing etc, as applicable, from either National Accreditation Board for Testing and Calibration Laboratories (NABL) or certificate for diagnostic/clinical trial labs or Certificate of GLP compliance /DSIR certification as issued by the Ministry of Science & Technology, GoI in the relevant discipline as applicable. An undertaking that the material being imported has been tested and free from HIV, Hepatitis B & C, Malaria and Syphilis. For transfer of samples, the Indian applicant should follow the WHO document 'Guidance on regulations for the transport of Infectious substances (2013-2014)'. There are specific packing instructions as per United Nations class (6.2) specifications to be followed during transport of infectious substances. Unless otherwise declared the biological materials such as blood and/or blood components; dried blood spots and faecal occult blood; medical or clinical wastes are to be considered under the 'infectious substance category'. ]]> <![CDATA[Create awareness among farmers, Agri minister tells scientists]]> https://biospectrumindia.com/news/95/8152/create-awareness-among-farmers-agri-minister-tells-scientists.html https://biospectrumindia.com/news/95/8152/create-awareness-among-farmers-agri-minister-tells-scientists.html Fri, 16 Jan 2015 12:44:00 +0530 The union agriculture minister, Mr Radha Mohan Singh has underlined the importance of fundamentals of agricultural growth for the development of country as he mentioned improved soil health, high productive seeds, modern agriculture practices and best practices, effective irrigation facilities, water to every agricultural land, apt marketing facility for agricultural produce are essential points for development of agriculture as a whole. Mr Singh was presenting his views at an event "Agri@8%- Challanges and Way out" organized by The Associated Chambers of Commerce of India (ASSOCHAM) in New Delhi on January 15, 2015. Various discussion points during the programme included efficient system of agricultural production and agricultural productivity; storage and distributon of food products; soil mapping, efficient water management; increasing yield and variety of crops; tradiitional farming; awareness building among farmers; balanced use of fertilisers; organic farming among a number of prespectives presented by the presenters. Mr Singh emphasised the need to create awareness among farmers about best practices in the agriculture sector. He urged students and scientist faternity from agriculture to create awareness among farmers of atleast one village of their hometown about various inititives in agriculture with the theme of "Mera Gaon, Mera Gaurav". He also mentioned that there are approximately 20,000 scientist and 50,000 students from agriculture,who are graduate or PhD's of agriculture. The function was jointly organised by ministry of agriculture, ministry of food processing industries, department of science and techonlogy, department of biotechnology, government of Bihar and NABARD. ]]> <![CDATA[IMA collaborate with NATHEALTH]]> https://biospectrumindia.com/news/95/4234/ima-collaborate-with-nathealth.html https://biospectrumindia.com/news/95/4234/ima-collaborate-with-nathealth.html Fri, 16 Jan 2015 12:42:52 +0530 Indian Medical Association (IMA) and Healthcare Federation of India (NATHEALTH) would soon sign a Memorandum of Understanding (MoU) to develop Code of Ethics for the healthcare sector in the country. A joint task-force is already working on the details. "Unethical behavior and business practices are always distressing and especially, in healthcare, as trust is integral to healing. It is imperative that we develop a nationally accepted, unified set of standard value-based practices that would guide the delivery of ethical healthcare services to patients," said Mr Shivinder Mohan Singh, president of NATHEALTH. An MoU would be able to support the government's aim of universal healthcare through strong self-regulation. Speaking on the occasion, Dr A Marthanda Pillai, president and Dr K K Aggarwal, Hony secretary general, IMA said, "Self Code of Ethics is the need of the hour. Our partnership with an inclusive institution like NATHEALTH will help us to achieve the goal of 'Clean Medical World' in collaboration with leaders in the healthcare sector, not only in healthcare delivery but also in other sectors like medical technology providers, diagnostic services, health insurance, healthcare education, healthcare IT, healthcare publishers/communicators and other segments. ]]> <![CDATA["Scientific research can lead to better healthcare"]]> https://biospectrumindia.com/news/95/5263/scientific-research-can-lead-to-better-healthcare.html https://biospectrumindia.com/news/95/5263/scientific-research-can-lead-to-better-healthcare.html Fri, 16 Jan 2015 12:42:22 +0530 In his address as the keynote speaker at the H3C Health Sciences Innovation Conference, at Mumbai, the union minister for health, Mr J P Nadda stated that the focussed academic research can go a long way in strengthening the health sector. "It can provide solutions to many challenges facing the country in providing accessible and affordable health care to all, particularly the needy and vulnerable. Similarly, IT can play a crucial role as an enabler to address several critical issues in the country's health sector," he remarked. The health minister recommended the collaboration between the Ohio State University and AIIMS, New Delhi in the field of regenerative medicine. He informed that the country's first Regenerative Medicine Center at AIIMS has been launched in partnership with the Center for Regenerative Medicine and Cell Based Therapies (CRMCBT) at The Ohio State University. The minister was hopeful that such ventures will give fillip to health based research in the country. Such research must be people-centric and benefit humanity, the minister stated. He urged students, fellows and faculty from the Ohio State University to collaborate with Indian universities and health institutions to undertake research in varied health issues. India with its huge population, the burden of communicable as well as non-communicable diseases, coupled with shortage of human resources in the health sector including doctors, specialists and para medical staff still faces several challenges, he stated. He looks forward to partnership with the Ohio State University and other such academic bodies to work together to address these challenges, he stated. The health minister assured political commitment towards all health issues in the country, and towards any collaboration with academic bodies that seek to work in the health sector in the country. Echoing the sentiments of the Prime Minister, he emphasised on need for paying attention to 'skill, scale and speed' while developing solutions to health issues. Skill is not a static process; it is continuous and succeeds with constant updation and sharing, he opined, adding that academic exercises such as this conference form a crucial element towards skill development and enhancement. Looking at the population of the country, scale assumes a realistic character too, he said. Shri Nadda said that a balance needs to be struck between quality and quantity when providing health services. Quality cannot be allowed to suffer to take care of the numbers. The minister reminisced about the role of the Ohio State University in enabling the Green Revolution in the country. Also present at the Conference were Dr Michael Drake, President of the Ohio State University; Dr M C Misra, Director, AIIMS New Delhi; and Prof. Chandan Sen, Ohio State University. More than 100 delegates from the US will be participating in the three day conference which will have about 60 technical sessions. ]]> <![CDATA[Affordable healthcare is a major concern area says VP]]> https://biospectrumindia.com/news/95/6746/affordable-healthcare-is-a-major-concern-area-says-vp.html https://biospectrumindia.com/news/95/6746/affordable-healthcare-is-a-major-concern-area-says-vp.html Fri, 16 Jan 2015 12:25:59 +0530 The lack of extensive and adequately funded public health services pushes large numbers of people to incur heavy out of pocket expenditures on services purchased from the private sector," stated the vice president while addressing at "5th Foundation Day and 2nd Convocation of the Institute of Liver and Biliary Sciences" on January 14. Mr Ansari said that healthcare infrastructure gaps remain substantial and are exacerbated by underutilisation of existing resources. The situation is further aggravated by the inequity in healthcare delivery across states and demographic segments. Rural areas are especially poorly served. Around seventy percent of our population lives in rural areas but only two percent qualified doctors are available in these areas. The vice president expressed his concern that Healthcare workforce remains inadequate and underutilised. Regulatory standards for public and private hospitals are not adequately defined and, in any case, are ineffectively enforced. A well functioning and effective regulatory system is required to manage the large and diverse set of healthcare service providers. The problems outlined above and some more are likely to worsen in future. Healthcare costs are expected to rise because, with rising life expectancy, a larger proportion of our population will become vulnerable to chronic Non-Communicable Diseases which typically require expensive treatment. Mr Ansari opined that the bulk of the population today relies upon private sector health providers, paying amounts which they cannot afford, because of the inadequate reach of the public sector. There must be substantial expansion and strengthening of the public sector health care system if we are to meet the health needs of rural and even urban areas. As supply in the public sector increases, it will free the vulnerable sections of society from dependence on high cost and often unreachable private sector health care. He said that the Institute of Liver and Biliary Sciences is a fine example of what the public sector can do and must do in the actualization of our desired goal to have a universal health coverage and thereby ensure healthy and economically productive population. He complemented all members of the Governing Council of the ILBS, Dr Sarin and his entire team for making the coveted vision of establishing new super-speciality medical institute a reality. He hoped that the Institute would continue to deliver quality public and community health care for all in the future and set a worthy example for other institutions to follow. ]]> <![CDATA[Scientists disagree with activists notion on GM crops]]> https://biospectrumindia.com/features/95/4091/scientists-disagree-with-activists-notion-on-gm-crops.html https://biospectrumindia.com/features/95/4091/scientists-disagree-with-activists-notion-on-gm-crops.html Fri, 16 Jan 2015 11:52:00 +0530 While activists have been questioning the use of GM crops by quoting various incidents where cattle had died after eating leaves of plants, the experts don't agree with such assertions. Besides that the scientists also refute accusations that the farmers have committed suicides due to BT Cotton. During an open discussion in session 'Use of modern technology in agriculture', the Indian high profile agriculture scientists ruled out any role of GM cotton in causing suicides of farmers in Maharshtra's vidarbha region. These included Dr R S Paroda, former director general, Indian Council for Agriculture Research, Dr Anupam Verma, senior scientist, Indian Agriculture Research Institute and Dr Deepak Pental, former vice chancellor, Delhi University. Requesting the central government to allowing more confined trials, these scientists in their talks mentioned about the need to have more data for research and analysis. At the same time the activists and certain sections of media are completely against any usage of GM crops. As per a source, it was highly visible during the debate. Dr Deepak Pental asserted that there were research proposals that could make a huge difference to societal issues faced by the country but due to opposition by the activistis, these got stalled. He said that it is important to allow the research to thrive. We have to take a decision whether to take this route or find alternatives." Lamenting the policy paralysis, Dr R S Paroda reportedly told the gathering that India doubled cotton production and has reduced the load of pesticides. India is exporting cotton worth $3 billion. The recent mention of GM crops in the environmental report submitted by the former cabinet secretary, T S R Subramaniam has again renewed the debate on the GM issue. The note of caution in the report is being seen as a pressure point on the ministry of environment to hold back the decisions on the issue. However, it would be interesting to see whether the Modi government holds back its horses on allowing more field trials and removing the state level hiccups or gives it a thumbs up in 2015. ]]> <![CDATA[B-MS sign immunotherapy pacts with Lilly]]> https://biospectrumindia.com/news/95/4141/b-ms-sign-immunotherapy-pacts-with-lilly.html https://biospectrumindia.com/news/95/4141/b-ms-sign-immunotherapy-pacts-with-lilly.html Thu, 15 Jan 2015 16:17:00 +0530 Bristol-Myers Squibb (B-MS) and Eli Lilly have entered into a clinical trial collaboration to evaluate the safety and efficacy of BMS' immunotherapy Opdivo (nivolumab) in combination with Lilly's galunisertib (LY2157299) as a potential treatment for advanced glioblastoma, hepatocellular carcinoma, and non-small cell lung cancer. Lilly will conduct the trials. Opdivo is a human programmed death receptor-1 (PD-1) blocking antibody that binds to the PD-1 receptor expressed on activated T-cells. Galunisertib is a TGF beta R1 kinase inhibitor that in-vitro selectively blocks TGF beta signaling, which promotes tumor growth, suppresses the immune system and increases the ability of tumors to spread. This collaboration will address the hypothesis that co-inhibition of PD-1 and TGF beta negative signals may lead to enhanced anti-tumor immune responses than inhibition of either pathway alone. "Advanced solid tumors represent a serious unmet medical need among patients with cancer. Our clinical collaboration with Lilly underscores Bristol-Myers Squibb's continued commitment to explore combination regimens from our immuno-oncology portfolio with other mechanisms of action that may accelerate the development of new treatment options for patients," said Mr Michael Giordano, senior vice president, head of development, Oncology, BMS. "Combination therapies will be the key to address tumor heterogeneity and the inevitable resistance that is likely to develop to even the most promising new tailored therapies," said Mr Richard Gaynor, senior vice president, Product Development and Medical Affairs, Lilly Oncology. He added, "To that end, having multiple cancer pathways and technology platforms will be critical in an era of combinations to ensure sustainability beyond any single asset." ]]> <![CDATA[FIT 2.0 released to promote correct insulin injection technique]]> https://biospectrumindia.com/news/95/4229/fit-2-0-released-to-promote-correct-insulin-injection-technique.html https://biospectrumindia.com/news/95/4229/fit-2-0-released-to-promote-correct-insulin-injection-technique.html Thu, 15 Jan 2015 14:15:00 +0530 The event also commemorated the 93rd anniversary of first successful insulin administration on 11th January 1921, at Toronto General Hospital, Canada. On this occasion, doctors from various hospitals including Bangalore Diabetes Hospital, Apollo Hospital and Advisory Board members of Forum for Injection Technique (FIT) provided tips on overcoming needle phobia for insulin injection dependent patients. Studies show that more than 80 percent of people have psychological resistance to even initiate an insulin therapy, despite it being indispensable for glycemic control to manage the disease. As per the new recommendations, special emphasis is to be given to counter allergic reactions arising out of incorrect usage of injections and usage in special groups like pregnant women and people with weak immunity. In pregnant women, injections should be given into the abdomen using a raised skin-fold. In the first trimester women should be reassured that no change in insulin site or technique is needed. In the second trimester lateral parts of the abdomen can be used to inject insulin, staying away from the skin overlying the fetus. In the third trimester, insulin can be injected over the abdomen while ensuring the skin fold is properly raised. Apprehensive patients may use the thigh or upper arm to inject themselves. Highlighting on the need to adopt correct injection technique, Dr Prasanna Kumar, senior endocrinologist and CEO, Bangalore Diabetes Hospital said, "Many people are unaware of the complications that may arise due to incorrect insulin administration. People have some favorite injection spots and they use that same spot over and over again. Sadly many people with diabetes haven't received proper education in terms of how to give an insulin shot correctly. If administered incorrectly, lipohypertrophy (LH) is a commonly occurring complication which often causes changes to the skin, and can be disturbing for patients. I appreciate FIT India's efforts to enhance awareness on lipohypertrophy as a complication that is known to be missed, when not diagnosed carefully." The FIT recommendations also suggest that correct injection technique can help protect against lipohypertrophy, unexplained hypoglycemia (low blood sugar) and blood glucose variation. Shorter needles can provide safety from injecting into muscle, as an insulin injection in the muscle may lead to hypoglycemia. Several factors including regular inspection of injection sites, preventing reuse of needle, correct site rotation, influence the success of insulin injection therapy. Dr Anjana Hulse, consultant, pediatric endocrinology, Apollo Hospital, said, "For children with diabetes, insulin injection is the only treatment and they do not have with choice in this regard. It is important to understand where insulin should be injected in the body. But many patients do not understand why this is critical. The recommendations by FIT India have improved the overall acceptance of insulin delivery and injections. FIT2.0 talks about best practices such as using a new needle for every injection, always rotating injection sites and more." The success of insulin injection therapy and the adherence to it depends on several factors such as a smooth insulin initiation process with counselling that alleviates the fear of needles, the insulin regime, length of needle and the method of administration. For example, it is always preferable to keep injectable therapy at room temperature, use a new needle for each injection, choose shorter needles with a smaller diameter, and inspect and palpitate the skin prior to each injection to ensure a comfortable injection experience. ]]> <![CDATA[EMA accepts marketing authorization application review for Praluent ]]> https://biospectrumindia.com/news/95/7887/ema-accepts-marketing-authorization-application-review-for-praluent-.html https://biospectrumindia.com/news/95/7887/ema-accepts-marketing-authorization-application-review-for-praluent-.html Thu, 15 Jan 2015 12:14:00 +0530 Praluent is an investigational monoclonal antibody targeting PCSK9 (proprotein convertase subtilisin/kexin type 9) that is intended for the treatment of patients with hypercholesterolemia. The MAA for Praluent contains data from more than 5,000 patients, including 10 Phase 3 odyssey trials. Together, with additional ongoing studies including odyssey outcomes outcomes, the odyssey clinical trial program will include more than 23,500 patients at more than 2,000 study centers in double-blind, randomized, placebo-and active-controlled trials ranging from 24 weeks to approximately 5 years. A biologics license application (BLA) for Praluent was submitted to the USFDA in the fourth quarter of 2014. The EMA and USFDA have conditionally accepted Praluent as the trade name for alirocumab. The safety and efficacy of alirocumab have not been fully evaluated by any regulatory authority. ]]> <![CDATA[AbbVie receives FDA approval for DUOPA]]> https://biospectrumindia.com/news/95/4192/abbvie-receives-fda-approval-for-duopa.html https://biospectrumindia.com/news/95/4192/abbvie-receives-fda-approval-for-duopa.html Thu, 15 Jan 2015 09:49:00 +0530 The US Food and Drug Administration (US FDA) has approved AbbVie's DUOPA (carbidopa and levodopa) enteral suspension for the treatment of motor fluctuations for people with advanced Parkinson's disease. DUOPA is administered using a small, portable infusion pump that delivers carbidopa and levodopa directly into the small intestine for 16 continuous hours via a procedurally-placed tube. DUOPA was approved by the FDA as an orphan drug, a designation granted to products intended for the treatment of rare diseases or conditions affecting fewer than 200,000 patients in the US. "There is unmet need for treatment options for patients with advanced Parkinson's disease. As the disease advances, it can be difficult to control motor features. In clinical trials, DUOPA was shown to significantly reduce the amount of off time advanced Parkinson's disease patients experienced," said Dr C Warren Olanow, professor, Department of Neurology and Department of Neuroscience, Mount Sinai School of Medicine, and lead investigator of the DUOPA pivotal trial. DUOPA provides patients with the same active ingredients as orally-administered carbidopa and levodopa immediate release, but is delivered in a suspension that goes directly into the small intestine via a tube placed by a percutaneous endoscopic gastrostomy procedure with jejunal extension (PEG-J). This type of administration is intended to bypass the stomach. "The FDA approval of DUOPA is another significant milestone for AbbVie's pipeline. This advancement is important for patients with advanced Parkinson's disease and their care teams, as it provides a new therapeutic option to help manage motor symptoms," said Dr Michael Severino, executive vice president, R&D and chief scientific officer, AbbVie. ]]> <![CDATA[Ready to move into next phase: Dr Renu Swarup]]> https://biospectrumindia.com/news/95/4225/ready-to-move-into-next-phase-dr-renu-swarup.html https://biospectrumindia.com/news/95/4225/ready-to-move-into-next-phase-dr-renu-swarup.html Wed, 14 Jan 2015 15:16:28 +0530 "BIRAC has been able to provide platform to the scientists for entreprenuership and translation work,"stated Dr Renu Swarup while speaking at the Australia Business Week in India 2015 event at New Delhi. Talking in partcular about the collaboration with Australian counterparts, Dr Swarup remarked further, "Since the iniatition of Indo-Australian Strategic Research Fund in 2006, much has been achieved so far. As we completed five years of partnership on various projects, there have been many accomplishments. So far eight rounds of funding have been completed and fifty projects supported These projects includes the ones on stem cells, neutraceuticals and bioremediation among other areas." Dr Swarup who is also senior advisor at department of biotechnology (DBT), revealed that the first Indo-Australian technology transfer was achieved on banana fortification technology. "Would like to move this into another direction now. Having discussions with colleagues in Austrlian government to take this forward. Our meeting in Sydney would reveal the projects moving into Phase 2." she added. The managing director at BIRAC, Dr Swarup mentioned that her organization has now got extensive experience in helping the entreprenuers to do product development. She emphasized on the need to focus on translational research. "We are trying to help build early translational capacity and skilled human resources for industry. The DBT has collaborated with European countries in both academic as well as industrial projects. Now is the time for next phase of collaboration," added Dr Swarup. ]]> <![CDATA[BioAsia 2015 collaborate with OPPI]]> https://biospectrumindia.com/news/95/3486/bioasia-2015-collaborate-with-oppi.html https://biospectrumindia.com/news/95/3486/bioasia-2015-collaborate-with-oppi.html Wed, 14 Jan 2015 13:14:48 +0530 The 12th edition of BioAsia 2015, has tied-up with the Organisation of Pharmaceutical Producers of India (OPPI) for co-organising a meet on supply chain and logistics. This would enable companies to identify new emerging market trends for a cost effective pharma supply chain management. "As Indian companies look to expand and supply to global markets, an agile, customised and cost-efficient supply chain is of paramount importance. Hence, the event will be a Government-Business platform to focus on the challenges and need a radical overhaul from the current state," said Mr Shakthi Nagappan, CEO, BioAsia. According to Mr Ranjana Smetacek, director general, OPPI, "Supply chain optimisation, from a cost, quality and overall integrity perspective critical for the pharmaceutical industry. BioAsia 2015 provides a platform for discussions that will benefit the industry and help us better serve Indian patients." ]]> <![CDATA[Piramal to invest in new technologies]]> https://biospectrumindia.com/news/95/5564/piramal-to-invest-in-new-technologies.html https://biospectrumindia.com/news/95/5564/piramal-to-invest-in-new-technologies.html Wed, 14 Jan 2015 13:14:05 +0530 Piramal Enterprises' Pharma Solution division is planning to invest $40 million on new equipment and modern technologies. "To serve our partners better, Piramal Pharma Solutions continues to invest in next generation technologies and R&D. The recent investments include areas such as anti-body drug conjugation (ADC), advanced flow reactor (ARF) and biocatalysis centre of excellence systems," the company said in a statement. In addition to the investment, it will also augment related infrastructure. Recently, the company completed a $10 million green field facility to double its discovery services capacity, and also approved a $20 million capacity expansion for hormonal (Morpeth) and ADC (Grangemouth) manufacturing. ]]> <![CDATA[A vaccine to quit smoking!]]> https://biospectrumindia.com/news/95/4510/a-vaccine-to-quit-smoking.html https://biospectrumindia.com/news/95/4510/a-vaccine-to-quit-smoking.html Wed, 14 Jan 2015 13:10:43 +0530 Researchers at The Scripps Research Institute (TSRI) have designed a new effective nicotine vaccine which they believe could help smokers and even drug addicts quit. Nicotine vaccines train the body to see nicotine as a foreign invader. To prompt this immune response, scientists have tried attaching nicotine derivatives called haptens to a larger carrier protein used in other approved vaccines. The body reacts to the vaccine by creating antibodies to bind specifically to nicotine molecules. When a person later uses tobacco, the anti-nicotine antibodies stop the nicotine molecules from entering the central nervous system and ever reaching the brain. "This study provides new hope that one could make a nicotine vaccine that succeeds in clinical trials," said Mr Kim Janda, lead author of the study. The study is published in the Journal of Medicinal Chemistry. ]]> <![CDATA[Medical devices industry appeals PM to rationalize duty structure]]> https://biospectrumindia.com/news/95/5456/medical-devices-industry-appeals-pm-to-rationalize-duty-structure.html https://biospectrumindia.com/news/95/5456/medical-devices-industry-appeals-pm-to-rationalize-duty-structure.html Wed, 14 Jan 2015 13:09:57 +0530 The AIMED has requested the prime minister Narendra Modi to help in rationalized inverted duty structure on medical devicesâ€‹ â€‹â€‹tâ€‹o encourage manufacturing in India. "Every Finance Minister laments about downslide in manufacturing but does not take the steps to create the rational tariff structure to encourage this. Succor may be given to dead/dying units when it's too late on piecemeal basis without a structured reform and segment specific strategy," said the association in a statement on January 13, 2015. AIMED has pointed out that currently import duty on finished medical device is far lower than duty on raw materials and inputs that go into making of medical devices resulting in making imports much cheaper than domestically manufactured devices."Indian medical device industry is poised for quantum jump. But we will lose a wonderful opportunity to leverage this situation and make India a global manufacturing hub if taxes are not rationalized," said Mr Rajiv Nath, Forum Coordinator, AIMED. "Unless tax anomalies are removed, manufacturing of medical devices in India will not really take off, with or without FDI, more important , the healthcare security of the country is at stake" Mr Nath has added. AIMED has advocated immediate reversal of this skewed tax structure to create a level playing field for domestic manufacturers and to encourage manufacturing within the country? We are not asking for 40% duty protection like the automobile industry, we can compete, but at least give us a level playing field. "India manufactured goods are further disadvantaged by (a) Export encouragement policies followed by countries like China and; (b) import substitution policies in the form of 'Preferential Public Procurement Policies' that are again followed in countries such as US and China to encourage domestic manufacturing ", said Dr Velu , managing director of Trivitron. For example, the Chinese government subsidizes all exports of medical devices by 17 percent. So even if an exporter sells below cost by 7 percent, he still makes a profit of 10 percent! This is topped by 25 percent Preferential Pricing Policy for Chinese manufacturers with 0 percent foreign equity. We don't even have a Buy Indian formal policy, even USA has a Buy American policy, he quipped. The existing structure has also resulted in steady closure of many domestic medical device manufacturing units with many erstwhile manufacturers simply turning importers to be in the business." When duty on competing imports are reduced by 17% in last five years with no proportionate reduction of duty on our raw materials etc it's not viable to manufacture for Indian investors how will having a 100% auto approval route for FDI make it viable for foreign MNC's ?" queried Dr. Velu. "There are already many MNC's with 100% owned subsidiaries with warehouses but no factories. Why will they have the headaches of putting up factories and training skills if they have already been given headache free facility to import at NIL duty rates? Additionally they circumvent sales tax by selling on high seas sales basis to institutions" he remarked. The Rs 30,000 crore or approximately $5 billion Indian medical device market is poised for quantum jump in the next couple of years. Projections are that Indian medical device sector will grow to $50 billion by 2020 even as Indian healthcare industry will touch $280 billion by this time. Medical device industry has been identified by the Central Government as one of the five key sectors which can shape up Prime Minister Modi's vision of 'Make in India' into reality but for this to happen, major impediments such as irrational tax structure need to be removed by withdrawing all concessional duty notifications on Basic duty and SAD. ]]> <![CDATA[Turkish life science industry's favorable investment climate ]]> https://biospectrumindia.com/news/95/5178/turkish-life-science-industrys-favorable-investment-climate-.html https://biospectrumindia.com/news/95/5178/turkish-life-science-industrys-favorable-investment-climate-.html Tue, 13 Jan 2015 13:05:31 +0530 The establishment of technology development zones that exempt pharmaceutical entrepreneurs and academics from income taxes until 2023 has played a particularly crucial role in driving R&D activity in the nation's life sciences industry. New analysis from Frost & Sullivan, 2014 Life Sciences Outlook in Turkey, finds that the market earned revenues of $14.53 billion in 2013. The study covers pharmaceuticals and clinical diagnostics. The pharmaceutical segment was valued at $14.04 billion in 2013 and is estimated to reach approximately $21.65 billion in 2018 at a compound annual growth rate (CAGR) of 9.1 percent. The clinical diagnostics segment accounted for the rest of the total life sciences market revenues in 2013 and is forecasted to hit $0.70 billion in 2018 at a CAGR of 7.4 percent. "Biologics, oncology drugs and blood-based products are expected to support the development of the life sciences market in a big way," said Frost & Sullivan Healthcare senior research analyst Ms Aiswariya Chidambaram. "The biologics segment, which accounted for 11 percent of the total Turkish pharmaceutical market in 2012, is poised to expand at a CAGR of 15 percent between 2013 and 2018. On the other hand, the oncology segment will witness strategic investments - including certain tax allowances, customs duty exemption and value-added tax exemption - worth more than $9 billion." The country's inviting investment scenario and pharmaceuticals export potential of nearly $300 billion to neighboring countries will help it quickly attain a strong status in the region. ]]> <![CDATA[Roche collaborate with Foundation Medicine for oncology]]> https://biospectrumindia.com/news/95/5179/roche-collaborate-with-foundation-medicine-for-oncology.html https://biospectrumindia.com/news/95/5179/roche-collaborate-with-foundation-medicine-for-oncology.html Tue, 13 Jan 2015 13:04:32 +0530 Roche and Foundation Medicine (FMI) have entered into a broad strategic collaboration to further advance FMI's market-leading position in molecular information and genomic analysis while providing Roche a unique opportunity to optimise the identification and development of novel treatment options for cancer patients. FMI supports physicians by providing comprehensive molecular information to characterise a tumor that is being matched with approved targeted therapy options and novel treatments under development. Understanding the comprehensive genomic profile of a cancer patient's disease will enable better personalised healthcare solutions to optimise treatment outcomes for patients. "We believe that putting molecular information at the center of cancer care will help transform the delivery of care for patients and speed the pace of drug discovery and development. The structure of our agreement with Roche also allows us to maintain the entrepreneurial spirit at Foundation Medicine and ensures that our business model, network of partnerships and objectives are not altered," said Mr Michael J Pellini, president and CEO, Foundation Medicine. ]]> <![CDATA[Protecting the public from unsafe compounded drug products: USFDA]]> https://biospectrumindia.com/news/95/5104/protecting-the-public-from-unsafe-compounded-drug-products-usfda.html https://biospectrumindia.com/news/95/5104/protecting-the-public-from-unsafe-compounded-drug-products-usfda.html Tue, 13 Jan 2015 12:56:49 +0530 In 2012, a devastating outbreak of fungal meningitis linked to a contaminated compounded drug product tragically resulted in the loss of 64 lives and caused more than 751 illnesses, many of which were very serious. These events were a powerful reminder of the potential harm that could be caused by unsafe compounding products. FDA is moving aggressively on many fronts to protect the public from such threats. For example, we have conducted more than 175 inspections of compounding facilities in the past two years. Some of these inspections were for cause and were performed after we received reports of serious adverse events related to drugs made by compounding pharmacies or when states requested our assistance. Other inspections were proactive, targeted at facilities identified through a risk-based model. Our proactive inspections were conducted in coordination with state officials from around the country and focused on each firm's sterile drug production, because drugs labeled as sterile are used in ways that could greatly compromise patient care and safety if they aren't actually sterile. Our findings uncovered a variety of problems with sterile drug production practices at these facilities. As a result of these inspections, numerous firms stopped making sterile drugs and many recalled drug products that had been made under substandard conditions. In some cases, we worked with state officials to revoke or suspend pharmacy licenses. We also issued warning letters to firms that were producing drugs under inadequate conditions, notifying them of violations of the law and the need to take steps to correct the violations and prevent their recurrence. We have also worked with the Department of Justice (DOJ) to hold facilities accountable if they harm patients or engage in serious violations of federal requirements that put patient safety at risk. Working with DOJ, FDA has initiated investigations and enforcement actions against compounding facilities that violate federal law - and we intend to continue this work with DOJ. In addition to our inspection and enforcement efforts, FDA has taken many steps to implement the compounding provisions of the Drug Quality and Security Act (DQSA) - legislation enacted by Congress last year in response to the fungal meningitis outbreak. To implement the compounding statutory provisions, FDA is establishing a policy framework to address compounding by state-licensed pharmacies as well as the new category of outsourcing facilities, which was created under the DQSA. Among other things, outsourcing facilities are facilities that compound sterile drugs and choose to register with FDA as outsourcing facilities, and they must comply with current good manufacturing practice requirements and are subject to FDA inspection on a risk-based schedule. Two years after the fungal meningitis outbreak our hearts continue to go out to the victims of the tragedy and their families. Our work on behalf of all patients who want and deserve medicines that do not subject them to undue risk is far from being done. FDA will continue to work with the states, the Department of Justice and others to enable Americans to have greater confidence in their compounded drugs. ]]> <![CDATA[Janssen inks Alzheimer's deal with AC Immune]]> https://biospectrumindia.com/news/95/8063/janssen-inks-alzheimers-deal-with-ac-immune.html https://biospectrumindia.com/news/95/8063/janssen-inks-alzheimers-deal-with-ac-immune.html Tue, 13 Jan 2015 12:55:24 +0530 AC Immune has entered into a worldwide exclusive license agreement and research collaboration with Janssen Pharmaceuticals,to develop and commercialise therapeutic anti-Tau vaccines for the treatment of Alzheimer's disease and potentially other tauopathies. Janssen Research & Development, an affiliate of Janssen Pharmaceuticals, will further develop the lead therapeutic vaccine, ACI-35, that is currently in a phase Ib clinical trial in Alzheimer's patients. ACI-35 is an active therapeutic vaccine stimulating the patient's immune system to produce a polyclonal antibody response against phosphorylated Tau protein. Under the terms of the agreement, AC Immune will receive an upfront payment and is eligible to receive research, development and commercialization milestone payments potentially totaling up to $509 million (CHF 500 million) for Alzheimer´s disease and a potential second indication outside of Alzheimer´s disease. Additionally, the company is eligible to receive tiered royalties on net sales for any approved products resulting from the collaboration. AC Immune and Janssen will co-develop ACI-35 through phase Ib completion. As of phase II and onward, Janssen will assume responsibility for the clinical development, manufacturing and commercialisation of ACI-35. Additionally, the two companies have entered a three year joint research collaboration to further characterise and develop novel vaccine therapies for the treatment of tauopathies. "This is our third major collaboration with pharmaceutical partners involving the Tau protein and underscores the strength of our technology platforms for targeting proteinopathies and our success in bringing to the clinic Tau and Abeta therapies and diagnostics," said Prof. Andrea Pfeifer, CEO of AC Immune. ]]> <![CDATA[Health delegation from Australia to explore partnerships in India]]> https://biospectrumindia.com/news/95/5182/health-delegation-from-australia-to-explore-partnerships-in-india.html https://biospectrumindia.com/news/95/5182/health-delegation-from-australia-to-explore-partnerships-in-india.html Tue, 13 Jan 2015 12:53:38 +0530 Led by the Hon Andrew Robb AO MP, Australia's Minister for Trade and Investment, ABWI is the largest Commonwealth-sponsored trade, investment, education and tourism mission ever undertaken to India, comprising around 450 business delegates. Nicola Watkinson, Australian Trade Commission's Senior Trade and Investment Commissioner for South Asia, said this mission reinforces the message that Australia is keen to identify, strengthen and deepen relationships with India. "Australia's healthcare and assisted living (also known as aged care) industries are known for world-leading technology, innovation, professional skills, and advanced research and development. "This has Australian companies well positioned to share their expertise, provide products and services to countries trying to support their ageing population, namely the elderly and frail people requiring aged care and healthcare," said Ms Watkinson. Patrick Kearins, Trade Commissioner and leader of the Health and Assisted Living delegation, said Australian organisations are keen to collaborate with Indian businesses to offer solutions to address industry concerns across many areas. "The delegation is meeting with India's leading hospital and healthcare providers, developers of retirement communities and senior Government of India officials with responsibility for health with the objective of learning about India's broader health, aged care and assisted living priorities and to see where they might be able to contribute through partnerships," said Mr Kearins. "Australia has one of the most established aged care sectors in the world, having evolved the current model over more than 50 years and can deliver multiple levels of care for seniors, their carers and families. "The aged care system in Australia is one of the most thoroughly regulated in the world and is used as a model by many other countries," said Mr Kearins. Senior health and living capabilities span services, products, leading-edge technologies, infrastructure, research and development (R&D), education and training in areas such as clinical neuroscience, cardiovascular conditions, oncology and assisted living. Dementia care in particular is emerging as a health priority. "Australian businesses also offer wide-ranging capabilities in the design, construction, management and provision of support services to aged care facilities and retirement housing, which offer fully integrated healthcare facilities and services. "This is complemented by an established medical device industry, with an internationally recognised capability to innovate and develop world-class products. This includes innovative and niche healthcare products, from the 'bionic ear' to continuous positive airway pressure devices to treat sleep apnoea," said Mr Kearins. The business delegation will be visiting New Delhi, Mumbai and Pune. India is Australia's11th largest trading partner with two-way trade of A$15.2 billion and fifth largest export market, with total exports of A$11.4 billion. Total Indian investment in Australia is near A$11 billion (up from A$600 million in 2006), while total Australian investment in India is over A$6.5 billion. ]]> <![CDATA[India to get national facility for regenerative medicine]]> https://biospectrumindia.com/news/95/4997/india-to-get-national-facility-for-regenerative-medicine.html https://biospectrumindia.com/news/95/4997/india-to-get-national-facility-for-regenerative-medicine.html Tue, 13 Jan 2015 12:51:45 +0530 The Ohio State University (OSU), second largest public research university in the United States, in association with AIIMS, New Delhi announced commencement of first H3C Health Sciences Innovation Conference in India. The first day of the conference witnessed multi-stakeholder discussion around regenerative medicine, nanotechnology and wound care. The conference is chaired by Prof Chandan K. Sen, a key leader at The Ohio State University and a scientist of Indian Origin. The Ohio State University pioneers in regenerative medicine providing strong inputs for the proposed centre in Delhi at the AIIMS campus, for which the Indian Council for Medical Research (ICMR) and the Department of Biotechnology (DBT) will be approached for funding. The conference explored opportunity to build international collaboration networks to jointly apply for these new international funding sources through many funding opportunities. Co chaired by Prof Amit K Dinda MD, PhD, professor, Department of Pathology, AIIMS, the conference witnessed participation from eminent dignitaries like Dr Maneesh Singhal, FACS, AIIMS; and Prof Mahesh C. Misra, director, AIIMS. The spotlight was on fostering industry relationships by inviting Indian industries towards R&D partnership - from basic sciences to clinical trials. The other pivotal aspects of this conference were to look at opportunities in vascular biology, neuroscience, material science, regenerative medicine and cord blood banking. Commenting on the occasion, Dr Chandan Sen, PhD, director of the Centre for Regenerative Medicine and Cell-Based Therapies at The Ohio State University said, "We are delighted to collaborate with AIIMS (India) as not only does it offer immense opportunities for co-operation but we can learn so much from the Indian experience given the breath and volume of cases and specific needs. At the same time we offer several sets of scientific expertise to enrich the new program at AIIMS." This conference will enable Ohio State faculty to meet colleagues with similar interests, discuss the latest technologies and share and exchange ideas for potential research collaborations not only with academic institutions but also with biotech and pharmaceutical companies, and hospital and health care systems. It is an exciting opportunity for research engagement," he said. ]]> <![CDATA[Govt to fund Ayurveda clinic research centre in Kerela ]]> https://biospectrumindia.com/news/95/4991/govt-to-fund-ayurveda-clinic-research-centre-in-kerela-.html https://biospectrumindia.com/news/95/4991/govt-to-fund-ayurveda-clinic-research-centre-in-kerela-.html Tue, 13 Jan 2015 12:50:40 +0530 The central government has pledged financial support to set up a state-of-the-art Ayurvedic Clinical Research Centre in Kerala to help scientifically validate traditional systems of healing and medicine and integrate them with mainstream public healthcare delivery. Union minister for state for AYUSH, Mr Shripad Yesso Naik gave the assurance as he announced the new National Programme of Ayurveda Inspired Research initiated by the Rajiv Gandhi Centre for Biotechnology (RGCB) and the proposed National Ayurveda Expo 2015 at a function on January 11, 2015. The RGCB is setting up a National Centre for Excellence for Ayurveda Inspired Discovery lead research into efficacy mechanisms involved in Ayurvedic therapeutics and has proposed two sister campuses: an Ayurvedic Clinical Research Centre at Konni in Kerala and a High Altitude Discovery Centre at Munnar in Kerala. Mr Naik said the Centre will fund the setting up the clinical research facility in Konni, as Kerala's minister for health and family welfare Mr V S Sivakumar promised to provide the approximately 50 acres of land required for the project. The union minister has been visiting Kerala for the past week to learn more about Ayurvedic practice, education and industry in the state. "The set-up in Kerala, including training and delivery system in both public and private sectors, is of a very high standard," Mr Naik said. "Kerala can contribute immensely towards raising the status of traditional healthcare systems for which we require scientific inputs, standardisation and certification processes." Mr V S Sivakumar noted that in Kerala "Ayurveda is not only an alternative way of treatment, but also one of the engines for the state's economic growth. The industry, which is worth Rs 1,000 crores annually aims to grow five-fold by 2020." He said that of the global herbal product market worth $80 billion, India's share is less than $1bn whereas China has a share of around $6-7 bn. "Events like the National Arogya Expo 2015 will augment the investment opportunities in R&D, including genomics and nanotechnology," he added. National Arogya 2015, an initiative of the World Ayurveda Foundation (WAF) in partnership with the RGCB, is proposed to be held in state capital Thiruvananthapuram from April 23-26, 2015 at the end of a month-long Ayurveda festival that will bring together practitioners, policymakers, manufacturers, R&D institutes, students and members of the public to widen the global reach of Indian traditional medicines. The proposed expo will have more than 400 exhibition stalls, scientific sessions, free AYUSH clinics, live Yoga demonstrations, Ayurvedic food festival and cooking classes. Shri Naik launched the Expo brochure. RGCB director professor M Radhakrishna Pillai said the proposed Centre for Excellence was a "small effort in facilitating the rediscovery of Indian traditional and holistic medicine." Among the objectives of the Centre of Excellence will be the analysis of Ayurvedic therapeutics for treatment response and their effect on patho-physiological processes and developing uniform protocols, compositions and components. The herbal products will be characterised using advanced technologies such as genetic bar coding, genetic fingerprinting and mass spectroscopy. The project will also include a research centre to study medicinal plant conservation, metabolic engineering to improve active plant components and a discovery programme looking for therapeutically significant molecules and compounds. Leading bio-medical companies such as central public sector enterprise ,HLL Lifecare Limited and other Ayurveda-based companies and organisations are expected to be partners in the project. Mr A Jayakumar, secretary general, Vijnana Bharati delivered the introductory address at the function. Dr S Saji Kumar, managing director, Dhathri Ayurveda, made a presentation on the Expo. Dr M Ayyappan, the chairman and managing director of HLL Lifecare Ltd; Dr J Hareendran Nair, managing director, Pankajakasthuri; Dr Anita Jacob, director, Department of ISM, Government of Kerala, Dr Raghunathan Nair of Ayurveda College Teachers' Organisation and Dr S Sunil Kumar of the WAF spoke on the occasion. ]]> <![CDATA[Celestial to launch antibiotic for diabetes]]> https://biospectrumindia.com/news/95/5175/celestial-to-launch-antibiotic-for-diabetes.html https://biospectrumindia.com/news/95/5175/celestial-to-launch-antibiotic-for-diabetes.html Tue, 13 Jan 2015 12:49:13 +0530 Hyderabad-based Celestial Biolabs will launch an antibiotic product for the treatment of diabetes. "The company is in the process of this natural sea based 100 percent vegetarian product tenatatively by April 2015," Celestial Biolabs said in a filing to the BSE. ]]> <![CDATA[Govt to establish National Innovation Centre]]> https://biospectrumindia.com/news/95/5165/govt-to-establish-national-innovation-centre.html https://biospectrumindia.com/news/95/5165/govt-to-establish-national-innovation-centre.html Tue, 13 Jan 2015 12:48:38 +0530 While addressing a Seminar "Innovation : the torchbearer of 21st Century" held on under the aegis of Vibrant Gujarat Summit 2015 at Gandhinagar, Union minister of state for science and technology, Mr Y S Chowdary said that his ministry is thinking to establish an Indian Innovation Centre and all states of the country will be members of this innovation centre. He also expresses the need to establish science city in every state of country. Mr Chowdary spoke about the challenges that science sector is facing. He said that many scientists published many research papers but they did not get proper connectivity and network. Innovations have been done but they did not get proper recognition. Innovation can solve the problem of how to showcase once a product is in the market and how to reach the needful people, he added. The minister said that youth get certificates but not skills and that creates the problem of unemployment. Each and every youth should get the job that is the challenge for us today. Mr Chowdary stressed the significance of innovation by saying that through innovation we can promote women to enhance their productivity, farmers to take insurance for their health and crop, development of medical instruments and applications. He said that his Ministry is committed to recognize the need of people and promote the innovations for them. During the seminar, Gujarat chief minister Ms Anandiben Patel inaugurated Gujarat Innovation portal and Gujarat National Law University's centre for intellectual property rights centre. Some MoUs were also signed with leading biotech and IT companies. ]]> <![CDATA[Kabra Drugs to enter cosmetic and deo segments]]> https://biospectrumindia.com/news/95/4911/kabra-drugs-to-enter-cosmetic-and-deo-segments.html https://biospectrumindia.com/news/95/4911/kabra-drugs-to-enter-cosmetic-and-deo-segments.html Mon, 12 Jan 2015 16:10:16 +0530 Kabra Drugs has informed Bombay Stock Exchange (BSE) that it is planning expansion and WHO specification implementation, for export and quality product. Also Kabra is planning to expand in cosmetic section, deodorant and perfumes. "Construction of premises is in full having approximate time expected in implementing all these programme is about one year," it said in its filing to BSE. The company is also starting production of herbal products. ]]> <![CDATA[NRGene's big data technology to enable maize genome analysis]]> https://biospectrumindia.com/news/95/4906/nrgenes-big-data-technology-to-enable-maize-genome-analysis.html https://biospectrumindia.com/news/95/4906/nrgenes-big-data-technology-to-enable-maize-genome-analysis.html Mon, 12 Jan 2015 14:39:45 +0530 NRGene and The International Maize and Wheat Improvement Centre (CIMMYT) are collaborating to generate the denovo genome assemblies of 20 tropical, subtropical, and highland maize genomes as part of CIMMYT's collaborative Seeds of Discovery project (SeeD). CIMMYT is an international non-profit research and training center focusing on research and training that increases sustainable agricultural productivity to feed a growing world population and improve the lives and livelihoods of farmers throughout the developing world, including Africa, Asia and the Americas. The collaboration is anticipated to augment the existing temperate reference for maize and significantly enhance molecular research and breeding for tropical agro-ecologies. "Technology is the lynchpin to address the pressing need to grow the world's food supply," said Dr Gil Ronen, CEO, NRGene. "The speed at which NRGene's big data genomic analysis delivers results means that CIMMYT be able to quickly apply the information to its practical research." Fifty percent of modern maize varieties grown in developing countries contain CIMMYT backgrounds. The goal of the collaboration is to help CIMMYT and its partners to accelerate the development of diverse, high yielding, nutritious maize that is better able to withstand infertile soils, drought, pests, and diseases. NRGene's GenoMAGICTM and DeNovoMAGICTM use unique algorithms to compile and analyze genomic big data at unprecedented speeds and accuracy. The results of the genomic analysis will allow CIMMYT to understand the exact genetic basis of variation in complex traits and later develop maize lines providing heartier yields. "We're constantly confronted by the challenges of sustainably increasing the productivity and profitability of maize production, especially in resource-limited tropical environments," said Dr Sarah Hearne, leader of SeeD's maize component, CIMMYT. "Maize is an increasingly essential crop, and we need tools that enhance our effectiveness in using the genetic resources stored in our gene banks to address the challenges of climate change and growing consumer demand for more nutritious foods. The DeNovoMAGIC analysis will give us some broad markers as to how to direct our R&D efforts." ]]> <![CDATA[PPP essential in dissemination of indigenous technology says agri minister]]> https://biospectrumindia.com/news/95/4721/ppp-essential-in-dissemination-of-indigenous-technology-says-agri-minister.html https://biospectrumindia.com/news/95/4721/ppp-essential-in-dissemination-of-indigenous-technology-says-agri-minister.html Mon, 12 Jan 2015 13:32:45 +0530 While addressing a programme at National Institute of Veterinary Epidemiology and Disease Informatics (NIVEDI) in Bengaluru, Union agriculture minister, Mr R M Singh urged upon ICAR to have major programs to improve the indigenous breeds as the products from the indigenous cattle also have health attributes to humans. He said that empirical evidence suggests that our indigenous breeds of cattle are relatively less prone to diseases as compared to exotic and cross-bred. He further said that the efforts should be made to improve indigenous stock in terms of production and productivity. Agriculture minister mentioned that the best indigenous breeds like Gir, Tharparkar, Rathi, Sahiwal etc. have better heat tolerance, feed conversion efficiency and disease resistance. Mr Singh said that in the XII Five Year Plan, the institute was renamed as the National Institute of Veterinary Epidemiology and Disease Informatics to expand its research activities with 32 AICRP centers covering all states and union territories of the country. Mr Singh mentioned that the role of scientists of NIVEDI continues to be in the prevention, control and eradication of diseases to help maximize animal production and safeguarding human health from those diseases transmitted by animals and their products using risk analysis data and precise diagnostics. He urged the institute to research and study the aspects which make the indigenous breeds resistant to diseases. He congratulated the Indian Council of Agricultural Research for setting up of a world class facility for research on epidemiology of animal diseases at National Institute of Veterinary Epidemiology and Disease Informatics (NIVEDI) in Bengaluru. In addition to development of diagnositics, Mr R M Singh said research partnership between the public and private sector is also essential to achieve faster progress and dissemination of technology to the end-users. Thus, there is a need to link these two sectors to have their activities complemented in a â€œPublic Private Partnershipâ€? mode. He expressed hope that the institute will make use of the new opportunities to give a new direction to their R&D and other service sector activities in a huge way. ]]> <![CDATA[Pharma companies to follow govt selling code from Jan 1]]> https://biospectrumindia.com/news/95/4905/pharma-companies-to-follow-govt-selling-code-from-jan-1.html https://biospectrumindia.com/news/95/4905/pharma-companies-to-follow-govt-selling-code-from-jan-1.html Mon, 12 Jan 2015 13:30:56 +0530 From January 01, 2015, the murky affairs in pharma industry are officially under surveillance. The code of conduct put by the government will be reviewed after six months in case it is not implemented in a desired way. In the future, government is also considering to make it mandatory. Generally as part of their strategy to achieve sales targets, the doctors are offered freebies, cruise tickets, paid vacations and sponsorships by pharmaceutical companies. The pharma industry also at the moment has a not so effective self-regulatory code that have been in place to control unethical sales promotion. Industry body IDMA, representing certain domestic companies and OPPI, which represents MNCs, have their own "self-regulatory'' codes. As per sources, the code specifies that any seminar, conference or meeting organized by a pharma company for promoting a drug or disseminating information, attended by medical practitioner will be on own cost. It further says that gifts for the personal benefit of healthcare professionals and family members (both immediate and extended) such as tickets to entertainment events are also not to be offered or provided by pharma companies, nor cash or monetary grants for individual purposes. Hospitality should also not be extended to any doctor or their family members. Referring to the earlier communication to industry associations sent out over two years back in March 2012, the department of pharmaceuticals says in the letter that the Uniform Code of Pharmaceutical Marketing Practices has been finalized after inputs by various stakeholders, and would be again reviewed six months after its implementation from January 1, 2015. The industry associations have to upload the Uniform Code on their websites and will be responsible for informing its members, and the government in case of violations. The code also adds that "where there is any item missing, the code of MCI as per the Indian Medical Council (Professional Conduct, Etiquette and Ethics) Regulation, 2002 as amended from time to time, will prevail''. ]]> <![CDATA[Dr Bergivinson takes over as DG of ICRISAT ]]> https://biospectrumindia.com/news/95/6878/dr-bergivinson-takes-over-as-dg-of-icrisat-.html https://biospectrumindia.com/news/95/6878/dr-bergivinson-takes-over-as-dg-of-icrisat-.html Mon, 12 Jan 2015 13:27:06 +0530 â€œInclusive and demand-driven innovation is the key to fighting poverty, eradicating hunger and malnutrition, and providing environmentally sustainable solutions to the most pressing challenges faced by smallholder farmers in the drylands.â€? This was stated by Dr David Bergvinson, as he assumed office as director general of the ICRISAT for a five-year term effective January 01, 2015. While emphasizing on the need to promote innovation, the newly joined DG mentioned,â€œIn tackling the poverty challenge persisting in the drylands of Asia and sub-Saharan Africa, innovation has to be driven by the demands of farmers and markets, and must recognize the important role of women and youth to enable inclusive market-oriented development." Dr Bergvinson articulated his passion and commitment for smallholder agriculture, and a strong desire to improve the lives of the hundreds of millions of impoverished smallholder farmers and their families living in the drylands, as he addressed senior management, scientists and staff at the ICRISAT global headquarters in Hyderabad, India, and virtually, at various ICRISAT locations in Africa. â€œWe must focus on what smallholder farmers need â€“ improved varieties, agronomic practices and market opportunities â€“ and work and think collectively to integrate and deliver our science-based solutions to the national level through partnerships.â€? Dr Bergvinson identified his two strategic priorities as the new ICRISAT Director General to be: Defining organizational values that build the kind of culture required of a knowledge and innovation institute; and mapping out country strategies as a vehicle for implementing market-oriented development. â€œI will work to make an enabling environment to empower all ICRISAT staff to do their very best to serve. Building on the foundation of success of ICRISAT, we should play a mentoring role to the next generation of scientists. We also have to face the challenge of rejuvenating agriculture to bring back the youth into the sector by making it more productive and profitable, and to ensure food security for all.â€? Prior to his appointment at ICRISAT, Dr Bergvinson was with the Bill & Melinda Gates Foundation in Seattle, USA, as Senior Program Officer, Crop Value Chains and Digital Design for Agriculture Development. He had been with the Foundation since 2007. Before joining the Foundation, Dr Bergvinson was a Senior Scientist with the International Maize and Wheat Improvement Center (CIMMYT) at its Mexico headquarters for over 12 years. His research background is in crop improvement, plant biochemistry, integrated pest management, and entomology. He is no stranger to ICRISAT, having interacted with the institute's scientists on projects dealing with grain legumes, village level studies, seed systems, and digital technologies in smallholder agriculture. Dr Bergvinson, who succeeded Dr William Dar as Director General for 15 years, is expected to move ICRISAT further in generating and sharing cutting-edge global scientific innovations, and in bringing about genuine pro-poor growth and inclusive market-oriented development in the dryland tropics of the world. ]]> <![CDATA[Biotech highly relevant at Vibrant Gujarat Summit ]]> https://biospectrumindia.com/news/95/4833/biotech-highly-relevant-at-vibrant-gujarat-summit-.html https://biospectrumindia.com/news/95/4833/biotech-highly-relevant-at-vibrant-gujarat-summit-.html Mon, 12 Jan 2015 13:20:45 +0530 The ongoing Vibrant Gujarat 2015 Global Summit is making headlines as the prime minister, Narendra Modi inaugurated it on January 11, 2015. The mega-event has attracted investors and industries across the globe. Therefore, it is highly unlikely for the biotech industry to remain behind. The Association of Biotechnology Led Enterprises (ABLE) was a part of an event with the Department of Science and Technology, Government of Gujarat and Gujarat State Biotechnology Mission (GSBTM). "Bio- Invest in Gujarat: Reshaping human lives through Biotechnology" organized at Gandhinagar was in coordination with, Industrial Extension Bureau (iNDEXTb) and KPMG (Knowledge Partner). As per information released by the Vibrant Summit organizers, the event was inaugurated by Mr Govindbhai Patel, minister of state, science and technology, Energy and Petrochemicals, government of Gujarat. In his address, the minister stated that the government is serious about development of Biotechnology (BT) in the state and added that BT is an important tool not only for economic growth and progress but also for social development. Mr Patel highlighted that BT progress based on development of skills, knowledge sharing and awareness, Technology, research and development can become key contributors of development for all and progress for all that can provide social benefits. He released four publications on biotechnology namely analytical report on biotechnology and life sciences companies in India, compendium of biotechnology and life sciences companies in Gujarat, directory of biotechnology and life sciences industry in Gujarat. Dr Sreeshan Raghavan, joint secretary, Department of Biotechnology, Government of India graced the event as the guest of honor. Mr S J Haider, secretary, Department of Science and Technology, Government of Gujarat, Mr Akshay Saxena, mission director, GSBTM along with international and national experts such as Dr Hans Soderlund director- Global Strategic Alliance - Paras Biopharmaceuticals from Finland, Prof Sir John Burn - Professor of Clinical Genetics, Newcastle University and Director & Head Institute of Human Genetics from UK, Prof. Ken-ichi Arai - Founding President, Asia-Pacific IMBN: Professor, Emeritus University of Tokyo from Japan, Dr. Ananda M. Chakrabarty - Prof. Univ. of Illinois, Chicago, Founder Amrita Therapeutics from USA, Dr. K.V. Prabhu, Joint Director Research, Indian Agriculture Research Institute, Dr K C Bansal, director, National Board of Plant Genetic Resources, ICAR, GOI, Dr Rashmi Barbhaiya, CEO & MD, Advinus Therapeutics and vice president ABLE among other dignitaries graced the inaugural session of the event. The one day international event was aimed at attracting investments in Gujarat and fostering a holistic innovation ecosystem in the field of biotechnology and life sciences. Apart from dignitaries who graced the inaugural session there were over 25 distinguished and renowned speakers and panel members comprising of senior representatives of Government of India, Industry representatives, Biotechnology & Life Sciences experts and academicians. Following the inaugural session, the program included 4 panel sessions on covering various aspects of biotechnology and using biotechnology in healthcare, agriculture and environment protection. The event saw participation from over 500 delegates that comprised of almost all varieties of stakeholders from the sector. ]]> <![CDATA[Indian Immunologicals to set up new vaccine plant in Puducherry]]> https://biospectrumindia.com/news/95/4825/indian-immunologicals-to-set-up-new-vaccine-plant-in-puducherry.html https://biospectrumindia.com/news/95/4825/indian-immunologicals-to-set-up-new-vaccine-plant-in-puducherry.html Mon, 12 Jan 2015 13:19:16 +0530 Vaccine manufacturer Indian Immunologicals Ltd (IIL), part of the National Dairy Development Board (NDDB), is setting up a new vaccine manufacturing facility in Puducherry involving an investment of Rs 300 crore, says reports. "The proposed new investment in Puducherry is a part of the union government's strategy to meet the anticipated doubling of demand for veterinary vaccines. It is estimated to reach 600 million doses over the next 3-4 years from around 300 million doses now," said NDDB chairman Mr T Nnda Kumar in a statement. However, the decision on whether to manufacture new vaccines at the proposed facility or expand the existing portfolio is yet to be taken. Reportedly, the land for the vaccine production facility is already acquired. ]]> <![CDATA[Roche's cobas TaqScreen MPX Test gains US FDA approval]]> https://biospectrumindia.com/news/95/4850/roches-cobas-taqscreen-mpx-test-gains-us-fda-approval.html https://biospectrumindia.com/news/95/4850/roches-cobas-taqscreen-mpx-test-gains-us-fda-approval.html Mon, 12 Jan 2015 13:16:29 +0530 Roche has announced that the US Food and Drug Administration (US FDA) has approved the cobas TaqScreen MPX Test, v2.0 for use in the detection and identification of HIV, HCV, and HBV in donations of human whole blood and blood components including source plasma. This latest version of the cobas TaqScreen MPX Test provides increased sensitivity and is the only FDA approved test to simultaneously detect and identify the most critical viral targets in one simple, ready-to-use assay. The combination of viral target detection and identification steps on a fully automated system offers workflow advantages to blood and plasma testing centers by eliminating the need for consecutive rounds of testing, and facilitating earlier donor counseling in the event of a positive result. "Since 1998, Roche has developed assays and systems designed to protect the blood and plasma supply on a global scale. By continually developing these innovative products we are striving for the highest level of safety for patients and efficiency for blood and plasma centers. This latest approval supports that commitment," said Mr Roland Diggelmann, COO, Roche Diagnostics. Along with CE Mark and recent approvals in Canada, Brazil, China, and India, FDA approval of the cobas TaqScreen MPX Test, v2.0 supports safety standards of blood and plasma centers worldwide. By utilising real-time, multi-dye PCR technology, individual specimens are simultaneously detected and discriminated for HIV, HCV and HBV, reducing the sample volume required and the turnaround time for donor testing. ]]> <![CDATA[Novartis announces robust Phase III results of its COPD drug]]> https://biospectrumindia.com/news/95/4910/novartis-announces-robust-phase-iii-results-of-its-copd-drug.html https://biospectrumindia.com/news/95/4910/novartis-announces-robust-phase-iii-results-of-its-copd-drug.html Mon, 12 Jan 2015 13:15:21 +0530 Novartis has announced positive top-line results from the pivotal Phase III clinical trial programs for QVA149 (indacaterol/glycopyrronium bromide) and NVA237 (glycopyrronium bromide) to support New Drug Applications (NDAs) with the US Food and Drug Administration (US FDA) for the long-term maintenance treatment of chronic obstructive pulmonary disease (COPD). The results from the EXPEDITION (including FLIGHT 1, 2 and 3 studies) and GEM clinical trial programs met their primary and secondary endpoints. "These data once again confirm the strong efficacy and favourable safety profiles of both QVA149 and NVA237. With submissions to the US FDA now complete for both treatments, we are closer to offering US patients with COPD a broader range of treatment options to help improve the significant burden of reduced lung function, and to help improve their lives," said Mr Vasant Narasimhan, global head of development, Novartis Pharmaceuticals. The FLIGHT 1 and 2 studies met their primary objectives with twice-daily QVA149 demonstrating statistically significant and clinically meaningful improvements in lung function (FEV1 AUC0-12) at Week 12, compared to indacaterol and glycopyrronium bromide in moderate-to-severe COPD patients. Improvements in overall health status, a secondary endpoint based on the St George's Respiratory Questionnaire (SGRQ) total score, and rescue medication usage were also seen with QVA149 compared to placebo at Week 12. The common adverse events reported for QVA149 were comparable to the individual components and placebo across the EXPEDITION studies. In the GEM 1 and 2 studies, twice-daily NVA237 demonstrated significant and clinically meaningful improvements in lung function (FEV1 AUC0-12h) at Week 12 in moderate-to-severe COPD patients compared to placebo; meeting its primary objective. An improvement in health status was also observed in patients at Week 12. The adverse events reported for NVA237 were comparable to placebo across the GEM studies. Data from the EXPEDITION and GEM programs are expected to be presented at major medical congresses later this year. ]]> <![CDATA[Horizon Discovery acquires Haplogen Genomics GmbH]]> https://biospectrumindia.com/news/95/4456/horizon-discovery-acquires-haplogen-genomics-gmbh.html https://biospectrumindia.com/news/95/4456/horizon-discovery-acquires-haplogen-genomics-gmbh.html Sun, 11 Jan 2015 10:55:00 +0530 Horizon Discovery Group has announced that it has agreed to acquire Haplogen Genomics GmbH, an Austria-based biotechnology company in a $9 million deal (£6.0m) in cash. The Haplogen Genomics platform represents a novel way to generate precisely engineered human cell lines efficiently and at a price that places genome editing within the reach of the broader academic research market through the use of haploid cells. The acquisition provides Horizon with a proprietary high-throughput cell line generation platform based on human haploid genetics that increases its cell line inventory by over 10-fold and simultaneously enables an on-demand cell line development service to be launched in the first quarter of 2015. The platform also underpins a high-throughput functional genomics screening service offering to academic, biotech and pharma customers, complementing Horizon's existing small and large molecule drug screening offerings. Dr Georg Casari, CEO, Haplogen GmbH, said, "We are extremely pleased to be able to put our research tools division into an exciting company like Horizon which is firmly establishing itself as the market leader in the fields of genome editing and personalized medicine. Having already established a strong working relationship with Horizon, it was easy to see the benefits of joining forces and we have great confidence in Horizon's ability to develop the haploid platform to its fullest potential." "This acquisition is a continuation of our ambition, stated at the time of our IPO, of expanding our intellectual property portfolio, product development capabilities and commercial offerings to gain broader access to important markets, especially basic academic research. The team in Vienna has proven in a short time that they can be a very effective and competitive force in the field of genome engineering, and we look forward to working with them to revolutionize the genomics field by enabling access to first-in-class products and services that disrupt the status quo," said Dr Darrin M Disley,CEO,Horizon Discovery Group. ]]> <![CDATA[Fructose, not table sugar is more harmful, says a study]]> https://biospectrumindia.com/news/95/4531/fructose-not-table-sugar-is-more-harmful-says-a-study.html https://biospectrumindia.com/news/95/4531/fructose-not-table-sugar-is-more-harmful-says-a-study.html Sun, 11 Jan 2015 10:12:00 +0530 Scientists at the University of UTAH discovered that high-fructose corn syrup is more toxic than table sugar in female mice. They fed mice with sugar in doses proportional to what many people eat, the fructose-glucose mixture found in high-fructose corn syrup was found to be more toxic than sucrose or table sugar, reducing both the reproduction and lifespan of female rodents. "This is the most robust study showing there is a difference between high-fructose corn syrup and table sugar at human-relevant doses," said biology professor Dr Wayne Potts, senior author of the study. The study found no differences in survival, reproduction or territoriality of male mice on the high-fructose and sucrose diets. The researchers speculate that may be because both sugars are equally toxic to male mice. "We speculate that the different sugars could favour different microbes in the guts of mice. Other research has shown differences in bacterial communities in the gut to be associated with metabolic diseases in rodents and in humans. It's possible one form of sugar causes more bacteria to get across your gut than another," said Dr James Ruff, the study's first author. It is scheduled for publication in the March 2015 issue of The Journal of Nutrition. ]]> <![CDATA[Sanofi, Regeneron announce positive results for Hypercholesterolemia drug]]> https://biospectrumindia.com/news/95/4493/sanofi-regeneron-announce-positive-results-for-hypercholesterolemia-drug.html https://biospectrumindia.com/news/95/4493/sanofi-regeneron-announce-positive-results-for-hypercholesterolemia-drug.html Sun, 11 Jan 2015 10:05:00 +0530 The trials compared the reduction from baseline in low-density lipoprotein cholesterol (LDL-C or 'bad' cholesterol) at 24 weeks with alirocumab versus placebo in patients with hypercholesterolemia. Alirocumab is an investigational monoclonal antibody targeting PCSK9 (proprotein convertase subtilisin/kexin type 9). "In the new monthly dosing trials, Odyssey Choice I and Choice II, the mean percent reduction in LDL-C from baseline was consistent with that seen in previous phase 3 trials evaluating alirocumab every other week dosing," said Dr Bill Sasiela, VP, program direction, cardiovascular and metabolic, Regeneron. "These results continue to validate our clinical development approach, which is designed to investigate various alirocumab doses and intervals to address patients' lipid-lowering needs." Odyssey Choice I evaluated the efficacy and safety of alirocumab in 803 patients with hypercholesterolemia at moderate to high cardiovascular (CV) risk. It compared alirocumab 300 mg every four weeks with placebo. More than two-thirds (68 percent) of patients also received statin therapy. Odyssey Choice II evaluated the efficacy and safety of alirocumab in 233 patients with hypercholesterolemia with high CV risk and/or a history of intolerance to two or more statins. It compared alirocumab 150 mg every four weeks with placebo. No patients received statin therapy. The most common adverse events in the trials (occurring in at least 5 percent of alirocumab-treated patients) were injection site reactions, headache, upper respiratory tract infection, arthralgia, nausea, sinusitis, pain in extremity, and fatigue. Injection site reactions occurred more frequently in the alirocumab groups compared to placebo. In both trials, alirocumab-treated patients who did not achieve their pre-specified LDL-C goals, or who did not achieve at least a 30 percent reduction in their LDL-C levels from baseline, were switched to receive alirocumab 150 mg every two weeks at 12 weeks. "Despite current lipid-lowering therapies, many patients at high CV risk struggle to reach optimal LDL-C levels," said Dr Jay Edelberg, head of the PCSK9 development & launch unit, Sanofi. "The Odyssey clinical trial program has provided key insights and allowed us to investigate alirocumab administered every four weeks in different patient populations, including those who cannot get control of their high LDL-C because of difficulty tolerating statin therapy." ]]> <![CDATA[Novartis collaborates with Intellia Therapeutics]]> https://biospectrumindia.com/news/95/4576/novartis-collaborates-with-intellia-therapeutics.html https://biospectrumindia.com/news/95/4576/novartis-collaborates-with-intellia-therapeutics.html Sat, 10 Jan 2015 10:41:00 +0530 Intellia Therapeutics has announced a five-year research and development collaboration with Novartis to accelerate the ex-vivo development of new CRISPR/Cas9-based therapies using chimeric antigen receptor T cells (CARTs) and hematopoetic stem cells (HSCs). CRISPR/Cas9-based gene editing holds promise across a range of gene therapy applications, including blood disorders, cancer and other genetic-based diseases. It has been shown to be an efficient and precise method for gene editing across multiple cell and tissue types. Under the terms of the agreement, Novartis receives exclusive rights to develop all collaboration programs focused on engineered CARTs. Within HSCs, Novartis and Intellia will jointly advance multiple programs, and have agreed to a process for assigning development and ownership rights, which will enable Intellia to develop its own proprietary internal HSC pipeline. In addition to increasing its equity holding in Intellia, Novartis is making an upfront payment, and providing technology access fees and funding for R&D programs during the five-year term of the collaboration. Intellia is also eligible to receive downstream success-based milestones and royalties. Intellia will gain access to certain Novartis intellectual property and technology for the development of its own product pipeline. Intellia also reserves the right to pursue additional enabling partnerships in other areas of therapeutic interest. "Our collaboration with Novartis is an important building block for Intellia that will greatly accelerate our effort to translate the promise of CRISPR/Cas9 into meaningful advances for patients. CARTs and HSCs represent two of the most immediate opportunities for CRISPR therapeutic development, and Novartis, as a leader in this space, is the ideal partner with which to develop strong product pipelines in these areas," said Mr Nessan Bermingham, CEO and co-founder of Intellia. ]]> <![CDATA[Aurobindo receives USFDA approval for hypertension drug]]> https://biospectrumindia.com/news/95/4609/aurobindo-receives-usfda-approval-for-hypertension-drug.html https://biospectrumindia.com/news/95/4609/aurobindo-receives-usfda-approval-for-hypertension-drug.html Sat, 10 Jan 2015 09:38:00 +0530 Valsartan tablets USP, 40mg, 80mg, 160mg and 320mg are the generic equivalent to the reference listed drug product (RLD) Diovan tablets, 40 mg, 80 mg, 160 mg and 320 mg respectively of Novartis and indicated for the treatment of hypertension, to lower blood pressure. The product falls under the therapeutic category of CVS (Cardio Vascular) and has a market size of approximately $2 billion for the twelve months ending October 2014 according to IMS. Aurobindo now has a total of 195 ANDA approvals (170 final approvals including 7 from Aurolife Pharma LLC and 25 tentative approvals) from USFDA. ]]> <![CDATA[National Health Policy 2015 out in the public domain]]> https://biospectrumindia.com/news/95/4525/national-health-policy-2015-out-in-the-public-domain.html https://biospectrumindia.com/news/95/4525/national-health-policy-2015-out-in-the-public-domain.html Fri, 09 Jan 2015 17:11:54 +0530 Despite the fact that it has cut the health budget in the last quarter by 30 percent, the Modi government is focusing on healthcare bigtime. The same is visible in the policy draft put in the public domain by the ministry of health and family welfare specifically mentioning that over 75 percent of the diseases are currently out of national programs, the policy draft for health has sought suggestions and feedback from concerned stakeholders and the general public. The draft also contains aims and objectives. While it thanks the National Health Policy of 1983 and that of 2002 in guiding the approach for the health sector in the Five-Year Plans and for different schemes, it stresses on the fact that in 13 years after the last health policy, the context has changed in terms of priorities. The National Health Policy accepts and endorses the understanding that a full achievement of the goals and principles as defined would require an increased public health expenditure which is 4 to 5 percent of the Gross Domestic GDP. It also notes that 40 percent of this would need to come from Central expenditure. At current prices, a target of 2.5 percent of GDP translates to Rs 3,800 per capita, representing an almost four-fold increase in five years. Thus, a longer time frame may be appropriate to even reach this modest target. The policy also recommends the formation of Steering Committees that bring together the Department of Pharmaceuticals, the Department of Biotechnology, the regulatory bodies, the Department of Industrial Policy and Promotion, the Departments of Science and Technology with the Health Ministry for drug and devices discovery and innovation. ]]> <![CDATA[Dr Azad Moopen elected to GVN's board of directors ]]> https://biospectrumindia.com/news/95/4470/dr-azad-moopen-elected-to-gvns-board-of-directors-.html https://biospectrumindia.com/news/95/4470/dr-azad-moopen-elected-to-gvns-board-of-directors-.html Fri, 09 Jan 2015 13:19:06 +0530 The announcement was made by Mr N Scott Fine, chairman, GVN Board of Directors, joined by Mr Robert C Gallo, MD, GVN co-founder and director of the GVN Center of Excellence, at the Institute of Human Virology, at the University of Maryland School of Medicine; Dr William Hall, MD, PhD, GVN co-founder and director of the GVN Center of Excellence, at the University College Dublin; and GVN president Dr Sharon Hrynkow, PhD. "It is an honor and privilege to join the GVN board of directors at this pivotal point in time," said Dr Moopen. "Collaboration among the public and private sectors is essential as we work as a global community to stem the spread of deadly diseases. I look forward to working with the board and the GVN centers of excellence to stop viral diseases in their tracks," he added. Dr Azad Moopen, a physician-turned entrepreneur and philanthropist from Kerala, is the CMD of Aster DM Healthcare, a healthcare conglomerate in the Middle East and India with more than 200 network units inclusive of hospitals, medical centers, pharmacies, diagnostics and specialty centers, healthcare consultancy service, academics & research to a medical college and an advanced medical city. Joining GVN as a senior advisor is Dr M V Pillai, MD, a professor of medicine at Thomas Jefferson University, and chairman of oncology at Aster MedCity, among his other leadership roles. "I look forward to working closely with GVN to strengthen ties in research and training of virologists in Kerala, India and later across the country," said Dr Pillai. ]]> <![CDATA[Amgen, Kite Pharma announce cancer immunotherapy collaboration]]> https://biospectrumindia.com/news/95/5396/amgen-kite-pharma-announce-cancer-immunotherapy-collaboration.html https://biospectrumindia.com/news/95/5396/amgen-kite-pharma-announce-cancer-immunotherapy-collaboration.html Fri, 09 Jan 2015 12:29:58 +0530 Amgen and Kite Pharma have entered into research collaboration to develop and commercialise the next generation novel Chimeric Antigen Receptor (CAR) T cell immunotherapies based on Kite's engineered autologous cell therapy (eACT) platform and Amgen's extensive array of cancer targets. The collaboration brings together Amgen's commitment and capabilities in advancing new approaches in immuno-oncology and Kite's industry-leading presence in CAR T cell therapy. Under the terms of the agreement, Amgen will contribute cancer targets, and Kite will leverage its proprietary CAR platform, R&D and manufacturing capabilities, and expertise. Kite will be responsible for conducting all preclinical research and cell manufacturing and processing through Investigational New Drug (IND). Kite will receive from Amgen an upfront payment of $60 million, as well as funding for R&D costs through IND filing. Kite will be eligible to receive up to $525 million in milestone payments per Amgen program based on the successful completion of regulatory and commercialization milestones, plus tiered high single- to double-digit royalties for sales and the license of Kite's intellectual property for CAR T cell products. Further terms of the agreement are not being disclosed. "The intersection of immunology and oncology represents one of the most promising approaches to delivering significant impact for patients with cancer. With our existing immuno-oncology portfolio, we believe joining forces with Kite Pharma will leverage our targets and their leading CAR T cell platform to advance another new promising therapeutic approach to fight cancer," said Dr Sean E Harper, executive vice president of R&D, Amgen. ]]> <![CDATA[Roche acquires Bina Technologies]]> https://biospectrumindia.com/news/95/4349/roche-acquires-bina-technologies.html https://biospectrumindia.com/news/95/4349/roche-acquires-bina-technologies.html Fri, 09 Jan 2015 09:35:00 +0530 Roche has announced the acquisition of Bina Technologies. Bina provides a big data platform for centralised management and processing of next generation sequencing (NGS) data. "The acquisition of Bina is a significant step for Roche to enable the promise of personalised healthcare by delivering the highest quality genomic data possible. Informatics and data management are critical to providing a seamless, end-to-end sequencing solution. Bina's products are designed to improve the efficiency and value of genomic analysis, and the company continues to develop new methodologies and algorithms that link NGS data to disease-relevant genetic markers," said Mr Dan Zabrowski, head of Roche Sequencing. The acquisition by Roche will enable Bina to accelerate product development and global commercialisation of the Bina-GMS as an enterprise software system supporting multiple sequencing technologies while developing a solution for Roche sequencing systems. Roche will also continue to grow Bina's unique interdisciplinary team of bioinformatics scientists, computer scientists and software engineers. "Roche's acquisition of Bina is a great validation of our work and technology. It is also an indication of how informatics and data science are going to play a major role in the future of medicine," said Ms Narges Bani Asadi, founder and CEO of Bina. She added, "We found great alignment between our company's vision and values, and we are very excited about the possibilities of working with Roche's global team and serving academic, translational and clinical research markets together in the future." Bina will be integrated into Roche Sequencing Unit in Q1 2015 and will continue to focus on expanding its innovative genomic analysis solutions portfolio. ]]> <![CDATA[Amended Food and Cosmetics Bill in Parliament soon]]> https://biospectrumindia.com/news/95/4457/amended-food-and-cosmetics-bill-in-parliament-soon.html https://biospectrumindia.com/news/95/4457/amended-food-and-cosmetics-bill-in-parliament-soon.html Fri, 09 Jan 2015 09:03:00 +0530 The Drug and Cosmetics (Amendment) Bill, 2015 has been prepared by the Department of Health and Family Welfare. The new bill is set to make amendments in the existing Drugs and Cosmetics Act, 1940. It will cover much anticipated upgradation and introduction of provisions for clinical trials and regulation of medical devices. The bill, if introduced in the Parliament, is expected to generate enough debate among lawmakers and media alike. This will fulfill the long pending demands of conccerned industry bodies. Keeping in view the government's intention to make changes in price control regime and promote generics, the Central Drug Standards and Control Organization (CDSCO) might soon release a new National List of Essential Medicines (NLEM) in 2015. ]]> <![CDATA[Dr Vardhan: Govt has identified biotech as key trust area]]> https://biospectrumindia.com/news/95/4357/dr-vardhan-govt-has-identified-biotech-as-key-trust-area.html https://biospectrumindia.com/news/95/4357/dr-vardhan-govt-has-identified-biotech-as-key-trust-area.html Thu, 08 Jan 2015 12:38:00 +0530 Speaking at an innovatively packaged `Bharat Ko Maano` session at the Youth Pravasi Bharatiya Divas in Gandhinagar on January 07, 2015, Dr Harsh Vardhan said the Prime Minister is particularly keen on institutionalizing linkages between resident Indians and the diaspora to promote exchange of ideas. The S&T minister stressed on the Make In India initiative and said that it provided a major platform to promote innovation. He said government has identified agricultural research, biotechnology, nano-sciences, affordable health care, clean energy and aerospace, as key areas for promoting R&D. Ayurgenomics and bio-entrepreneurship are also among the thrust areas. Dr Vardhan urged the Indian diaspora to actively consider pursuing research and innovation in India. "Come back and innovate in India. Have faith in our capabilities and ability to support," he said. ]]> <![CDATA[GM tech requires caution: Subramanian commitee report]]> https://biospectrumindia.com/news/95/4351/gm-tech-requires-caution-subramanian-commitee-report.html https://biospectrumindia.com/news/95/4351/gm-tech-requires-caution-subramanian-commitee-report.html Thu, 08 Jan 2015 12:04:41 +0530 The committee headed by the former cabinet secretary, Mr TSR Subramanian in its report submitted to the government has sounded a note of caution as it mentioned that while utilizing science and technology their limitations as well as the need for appropriate human intervention should not be lost sight of. "The potential consequences of mindless use of science and technology could possibly be illustrated by referring to the potential for medium/ long-term adverse affects through unprepared introduction of Genetically Modified (GM) food crops," the report that has been made official says. While other ministries naturally would aggressively push for early field trials and induction, the role of the MoEF&CC may have to be one of being a Devil's Advocate to advise due caution. Noting that Europe does not permit field trials, and that the average Indian farm is of very small size (which could lead to severe adverse impact on biodiversity through gene-flow) also noting that there are no independent expert agencies in the country, perhaps the MoEF&CC may ask for greater assurance in respect of potential adverse effects in the medium and long run.This is not to argue that use of science or technology should be limited; more to highlight the fact that appropriate caution needs to be taken. The committee has recommended that the use of science and technology, wherever possible and appropriate should be encouraged; approval and enforcement agency should use latest technology to the maximum possible. It remains to be seen how the government is going to responds to the recommendations by the commitee. ]]> <![CDATA[Canada quarantines APIs by India firm]]> https://biospectrumindia.com/news/95/4284/canada-quarantines-apis-by-india-firm.html https://biospectrumindia.com/news/95/4284/canada-quarantines-apis-by-india-firm.html Thu, 08 Jan 2015 11:17:00 +0530 Canada has quarantined the health products made with active pharmaceutical ingredients (APIs) from India's Sri Krishna Pharmaceuticals due to data integrity concerns. Health Canada is taking the action as an interim precautionary measure to help mitigate any potential risk. Under the quarantine measures, Canadian importers and distributors have stopped distributing APIs or finished dosage form products containing active ingredients from this site. At this time there is no identified risk to health, and Health Canada is not requesting a recall of any of the products. Health Canada has stated that the action applies to APIs from Sri Krishna Pharmaceuticals, which are used to make finished drug products that are sold to consumers. Health Canada has compiled an initial list of products affected by the quarantine. The list will be updated as new information becomes available. ]]> <![CDATA[GP Singh appointed new CEO of Jubilant Pharma]]> https://biospectrumindia.com/news/95/4324/gp-singh-appointed-new-ceo-of-jubilant-pharma.html https://biospectrumindia.com/news/95/4324/gp-singh-appointed-new-ceo-of-jubilant-pharma.html Thu, 08 Jan 2015 10:50:29 +0530 Mr GP Singh will have an overall responsibility for the operations under Jubilant Pharma and will report to the Jubilant Pharma Board. He will be based in the United States. Prior to Jubilant, Mr Singh had served as president of Sun Pharmaceuticals, USA and contributed to the growth of Sun's US business. He has worked extensively both in India and in the US in various leadership roles pertaining to Strategy, M&A, Commercial and Operations. The appointment of Mr Singh as CEO of Jubilant Pharma strengthens the management structure of the company and follows the appointment of Mr Pramod Yadav and Mr Rajesh Srivastava as co-CEOs of the Life Science Ingredients business of Jubilant Life Sciences. Commenting on the appointment of Mr Singh, Mr Shyam S Bhartia, chairman and managing director and Mr Hari S Bhartia, co- chairman and managing director, Jubilant Life Sciences said, "We are pleased to welcome Mr Singh into the Jubilant family to complete our pharma consolidation. Our Pharmaceuticals segment has attained significant scale and the businesses therein have great potential for growth. Mr. Singh's rich experience in Pharmaceuticals industry will help the company to enhance its focus and competitiveness thereby unlocking shareholder value." ]]> <![CDATA[Janssen and Vectura ink pact]]> https://biospectrumindia.com/news/95/4276/janssen-and-vectura-ink-pact.html https://biospectrumindia.com/news/95/4276/janssen-and-vectura-ink-pact.html Thu, 08 Jan 2015 09:59:00 +0530 Vectura Group has announced that the company has entered into a global development and licence agreement with Janssen Biotech, for the exclusive development of novel anti-inflammatory therapies for the treatment of asthma/ chronic obstructive pulmonary disease (COPD). The collaboration will focus initially on the development of a Phase II candidate and has the potential to include additional clinical-stage candidates. The collaboration will leverage Vectura's expertise and proprietary dry powder inhaler technologies in the development of inhaled therapeutics. Vectura will apply its delivery technologies to develop Janssen's pulmonary products into late-stage clinical development and commercialisation. Janssen will lead the clinical development programmes, with Vectura taking responsibility for pharmaceutical development and preparation for Phase II clinical trials. The deal comprises upfront and development milestones and a tiered royalty on net sales. Financial terms of the agreement are not disclosed. Dr Chris Blackwell, chief executive, Vectura, commented, "Vectura's role in this agreement is to apply its expertise in the development of products for airway-related diseases and to utilise its technology/device platform offerings, some of which have regulatory and commercial validation. Vectura continues to be viewed as a partner of choice by companies seeking to address the unmet medical needs of patients with airway diseases." ]]> <![CDATA[AAPI to collaborate with India ]]> https://biospectrumindia.com/news/95/4277/aapi-to-collaborate-with-india-.html https://biospectrumindia.com/news/95/4277/aapi-to-collaborate-with-india-.html Thu, 08 Jan 2015 09:54:00 +0530 American Association of Physicians of Indian Origin (AAPI), has announced the launch of a special initiative to collaborate with Indian healthcare agencies to improve infrastructure and awareness on head injury, trauma and hepatitis in the country. Actor Mr Amitabh Bachchan has pledged to be the ambassador of AAPI's campaign. "Our contribution is also in response to the call of Prime Minister Narendra Modi for the Indian diasporas to participate in the development of India. On the eve of the Pravasi Bhartiya Bivas, and to mark the 100th year of Gandhiji's return to India, the physician and healthcare community in the United States will this year focus on three key initiatives - trauma and brain injury, women's health, and women-led leadership. We thank Mr Amitabh Bachchan for his commitment to the cause of trauma and brain injury," said Ms Seema Jain, president of AAPI. AAPI has also announced that its next Global Health Summit (GHS) would be held in January 2016 in Delhi focussing on two key themes - trauma and brain injury, and women-related issues. ]]> <![CDATA[APAC's type 2 diabetes treatment market to hit $10.5 Bn by 2020 ]]> https://biospectrumindia.com/news/95/4281/apacs-type-2-diabetes-treatment-market-to-hit-10-5-bn-by-2020-.html https://biospectrumindia.com/news/95/4281/apacs-type-2-diabetes-treatment-market-to-hit-10-5-bn-by-2020-.html Thu, 08 Jan 2015 09:36:00 +0530 The company's latest report states that of the four major APAC countries (China, India, Japan and Australia), China will see the fastest expansion, with a CAGR of 11.1 percent over the forecast period. This will be driven by an increase in the prevalent population due to urbanization, and by expected drug launches. Ms Arti Singh, analyst, GBI Research, said, "The increasing diabetic population in India and China is the major reason behind the diabetes treatment market growth in the APAC region as a whole. "While Metformin is expected to retain its dominant position in the treatment algorithm for type 2 diabetes, the anticipated launch of promising pipeline molecules, including several drugs with novel mechanisms of action, may also contribute to market expansion." The analyst notes that there is uncertainty in the future type 2 diabetes treatment market, as sulfonylureas are currently the favored combination drugs with metformin, and a number of promising GLP-1 agonists, SGLT inhibitors and DPP-4 inhibitors are in the pipeline. Ms Singh continues, "While sulfonylureas typically have a very low annual cost of therapy, the pipeline drugs are expected to have a very high cost, meaning that even a small swing in their market penetration will have a significant impact on growth. "However, if these late-stage pipeline drugs fail to show consistently strong efficacy profiles across Phase III trials, or are found to have a slight chance of causing a serious adverse event, such as cancer, their commercial potential will be severely reduced." The analyst concludes that the widespread use of sulfonylureas and metformin, and the high level of competition among pipeline drugs, which could reduce the rate at which novel drugs can enter the market, will be the main barriers to market expansion over the forecast period. ]]> <![CDATA[Nestle Health Science invests $65 Mn in Seres]]> https://biospectrumindia.com/news/95/6914/nestle-health-science-invests-65-mn-in-seres.html https://biospectrumindia.com/news/95/6914/nestle-health-science-invests-65-mn-in-seres.html Wed, 07 Jan 2015 14:31:28 +0530 Together with its recently announced $48 million Series C preferred stock financing, Seres Health had over $110 million of cash and investments at the end of 2014. In connection with the investment, Nestle Health Science's CEO, Mr Greg Behar, joined the Seres board of directors. The proceeds from these financings will fund the further development of Seres' first-in-field, lead product candidate, SER-109, for preventing the recurrence of Clostridium difficile infection, into Phase 3 clinical trials as well as the advancement of the company's pipeline of therapeutics to treat other diseases of the human microbiome. Seres is developing the first Ecobiotic therapeutic products, novel drugs to treat important diseases by targeting the underlying biology of the human microbiome. Current product candidates span infectious, metabolic, and inflammatory diseases. "Nestle Health Science has identified the microbiome as an area of strategic importance for our emerging novel therapeutics practice and we expect that investing in an industry leader like Seres Health will help us reach our ambitions of addressing health conditions in the area of Gastrointestinal, Metabolic and Brain Health," said Mr Greg Behar, CEO, Nestle Health Science. "With its mission to produce innovative microbiome therapeutics for patients, Seres is an ideal investment for us as we move forward our goals of shaping new approaches to health management." "We are excited about Nestle Health Science's commitment to providing patients with novel therapeutics," said Dr Roger J Pomerantz, president, CEO and chairman of Seres Health. "Nestle Health Science has made the microbiome a priority and we are pleased they view Seres as the leader in microbiome therapeutic development. We expect this investment will accelerate the discovery and development of our pioneering drugs in this new field." "Having worked for several months with the Nestle Health Science team in evaluating partnership opportunities, I am impressed by their vision to create an innovative business," said Dr Noubar Afeyan, managing member and CEO of Flagship Ventures, and co-founder and lead investor of Seres Health. Seres is a microbiome therapeutics platform company developing novel class of biological drugs designed to treat diseases by restoring the function of a dysbiotic microbiome. ]]> <![CDATA[J&J begins Ebola vaccine trial in humans]]> https://biospectrumindia.com/news/95/4204/jj-begins-ebola-vaccine-trial-in-humans.html https://biospectrumindia.com/news/95/4204/jj-begins-ebola-vaccine-trial-in-humans.html Wed, 07 Jan 2015 12:59:03 +0530 The trial is being led by the Oxford Vaccine Group, part of the University of Oxford Department of Pediatrics. Recruitment in the trial is underway, and the first volunteers have received their initial vaccine dose. Enrollment is expected to be completed by the end of January. Johnson & Johnson also announced that Janssen, in partnership with Bavarian Nordic A/S, has produced more than 400,000 regimens of the prime-boost vaccine for use in large-scale clinical trials by April 2015. A total of 2 million regimens will be available through the course of 2015, with the ability to quickly scale up to 5 million regimens, if required, over a 12- to 18-month period. This increased projection is an update to Janssen's previous goal of producing more than 1 million regimens by the end of 2015, with 250,000 regimens for broad application in clinical trials by May 2015. "As a leader in the field of global health, we have a responsibility to act swiftly as Ebola continues to cause suffering among patients, families and health care workers in West Africa," said Mr Alex Gorsky, chairman & CEO, Johnson & Johnson. Modelling by the London School of Hygiene and Tropical Medicine to advise the World Health Organization (WHO) indicates that to bring the epidemic under control, current projected demand for a preventive vaccine ranges from a minimum of 100,000 doses to protect frontline workers to a high-end of 12 million doses for large-scale adult vaccination in the three affected countries. "Because every day counts, we are substantially accelerating the production of our vaccine regimen," said Dr Paul Stoffels, chief scientific officer and worldwide chairman, pharmaceuticals, Johnson & Johnson. "Through the unprecedented collaboration among the global health community, our goal is to bring this vaccine to families and frontline health care professionals as fast as possible." ]]> <![CDATA[Delhi to host Australian lifesciences trade delegation ]]> https://biospectrumindia.com/news/95/4183/delhi-to-host-australian-lifesciences-trade-delegation-.html https://biospectrumindia.com/news/95/4183/delhi-to-host-australian-lifesciences-trade-delegation-.html Wed, 07 Jan 2015 12:40:07 +0530 As a part of Australian Business Week in India (ABWI) 2015, the 19 member Australian Health and Life Sciences delegation along with India's leading healthcare and pharma companies will try to understand how Australia and India can collaborate on new drug development, solutions and innovation in Tropical Medicine. The event theme is Life Sciences and Tropical Medicine - Partnership Opportunities in New Drug Development and Delivery and will be held on January 12, 2015 at New Delhi. The themes for discussions include the ones on multi-shore clinical trials and tapping into Australian infrastructure to progress novel drug development; addressing India's need for an increased focus on R&D in pharma and achieving this through international collaborations and the ways how Australia can assist India in Drug discovery & development. Besides that the health roundtable on India's Healthcare, Biotechnology and Healthcare agenda is being held too at New Delhi on January, 13. The 25 member Australian healthcare and Life sciences delegation along with senior officials from the Health department from the Government of India. Aged care is emerging as an important sector in India, with models of delivery being trialled ranging from home care to medically assisted living. India's current healthcare expenditure is around five per cent of national GDP, of which one per cent is funded by the Indian Government. The interactive session with feature a discussion with the Indian government healthcare representatives to discuss about India's healthcare, biotechnology and medical research agenda. The Australian Life Sciences & Tropical Medicine delegation comprises of Australian providers of training & skill development in healthcare, especially in aged care & assisted living; Manufacturers of Bio medical products; Medical devices; Research agencies involved in - Vaccines & Oncology; Drug Discovery firms; and clinical trials providers. Among the prominent speakers are Mr Andrew John Robb, minister for trade and investment, Australia; Mr Jagat Prakash Nadda, minister for Health and family welfare, government of India; Dr Vishwa Mohan Katoch, secretary, department of health research, ministry of health and family welfare, and director general, Indian Council of Medical Research; Dr Arun K. Panda, additional secretary (Health), Department of Health; Ms Nicola Watkinson, Senior Trade Commissioner, Australian High Commission. ]]> <![CDATA[Govt must coordinate activities of its health departments, say experts]]> https://biospectrumindia.com/news/95/4203/govt-must-coordinate-activities-of-its-health-departments-say-experts.html https://biospectrumindia.com/news/95/4203/govt-must-coordinate-activities-of-its-health-departments-say-experts.html Wed, 07 Jan 2015 12:33:07 +0530 "Non-communicable diseases are a threat to the developing and under developing countries" stated K Srinath Reddy, president, Public health foundation of India elaborating on the adverse effects of non-communicable diseases which targets the young population as well. These diseases cause loss of productivity which leads to disabilities. He said that non communicable disease agenda is a core element which leads to sustainable development. He was speaking on the 3rd day's session, chaired by Dr Manju Sharma, pertaining to the symposium held for Health and Development which took place in the ISC 102nd of Science and Technology for Human development in Mumbai University Campus on January 06, 2015. All the speakers shared one view in common that the government should have co-ordination between the various health care departments and each department should come ahead and actively take part in the sanitation and innovation ideas that could help in curbing the non-communicable diseases and that each person is wholly responsible for the society and one should not wait for answers from the government or others. "Injuries and disabilities are going up" said Dr Vijayshil Gautam, professor and head, Trauma and Emergency Care, All India Institute of Medical Sciences AIIMS, Patna who presented on the topic "Road safety and Trauma prevention" Professor Gautam spoke about road accidents which contribute highly to the death rate. Uttar Pradesh is the state which contributes to killing maximum number of people and sadly is recorded under industrial death rather than road accidents. People are unaware or rather not empowered enough to deal with accidents and panic in case they witness one. Society as a whole needs to be empowered with knowledge and information on various health aspects in case of an emergency. "He who has health has hope: and he who has hope has everything" began Sandeep Kumar, director, AIIMS, Bhopal, who summarized the session of health and development. According to the world health organization that health indicators can help in the measurement of sustainable development goals and support governance. He further emphasized that healthy people are better able to learn, work and contribute to the economies and societies....sustainable development leads to improvement of health by adopting smart strategies for the reduction of communicable diseases, maternal and child health, nutrition. Mr Narendra Kumar Arora, Executive Director of the International Clinical Epidemiology Network, India spoke on the topic of "economic development and child health" in which he applauded the government for polio eradication which is one of the most innovative public health achievements. Further he added that the country turned the tide of HIV epidemic, cutting new infections by more than half in just a decade and averting the disaster that had been predicted by many. He emphasized that educating mothers and processing of clean water are two important steps in the development of child health. ]]> <![CDATA[AHLL acquires Nova Specialty Hospitals ]]> https://biospectrumindia.com/news/95/4195/ahll-acquires-nova-specialty-hospitals-.html https://biospectrumindia.com/news/95/4195/ahll-acquires-nova-specialty-hospitals-.html Wed, 07 Jan 2015 12:31:10 +0530 Apollo Health and Lifestyle Limited (AHLL), has successfully completed the acquisition of Nova Specialty Hospitals (NSH). The deal is in the range of Rs 135-145 crore subject to final closure. Nova Specialty Hospital's existing centers will serve as new centers under the Apollo brand name. This acquisition fits into the growth strategy of AHLL, providing a larger footprint, including in some markets where the company has no presence currently. Commenting on this strategic move, Ms Sangita Reddy, joint managing director, Apollo Hospital Enterprises said, "AHLL is currently present in the secondary care segment through the Day Surgery & Cradle formats. Given the immense potential and the need for quality healthcare delivery closer to the home, this acquisition will enable AHLL to significantly expand its' footprint." This acquisition will also mark the entry of Apollo in new markets such as Mumbai, Jaipur and Kanpur" she added. In the coming months, Apollo will re-launch these centres with new branding, an expanded menu of services and quality systems built on Apollo's deep expertise in the hospitals space." The acquired chain of Nova Specialty Hospitals is spread over eight cities and will add to the Apollo network of 45 Modular OTs, over 350 patient beds, with an average 20,000 SFT of built-up space in each center. These centers provide both In-patient and OPD services with 60 percent of the procedures currently being done as day procedures. The combined network will clock a turnover between Rs 115 - 125 crore for the year ending Mar' 15 and with the group synergies that Apollo brings to the table, management is confident of achieving break even in the next 18 to 24 months. ]]> <![CDATA[Pfizer acquires Redvax GmbH]]> https://biospectrumindia.com/news/95/4219/pfizer-acquires-redvax-gmbh.html https://biospectrumindia.com/news/95/4219/pfizer-acquires-redvax-gmbh.html Wed, 07 Jan 2015 12:29:33 +0530 Pfizer has announced that it has acquired a controlling interest in Redvax GmbH, a Swiss biopharmaceutical company. This transaction provides access to a preclinical human cytomegalovirus (CMV) vaccine candidate, as well as intellectual property and a technology platform related to a second, undisclosed vaccine program. The CMV vaccine program will complement Pfizer's robust research portfolio of high-quality and life-saving investigational vaccines and place it among the leaders in CMV research and development. CMV is a herpes virus, infecting 50-90 percent of the adult population, with a majority remaining asymptomatic. A large segment of young adults, especially women of childbearing age who remain CMV negative, are at high risk of CMV infection during pregnancy and of passing the infection on to the unborn child (congenital infection). There are potentially serious and lifelong consequences for babies born with the disease. One out of every five children born with CMV infection may experience hearing loss and severe neurologic disorders. More children have disabilities due to congenital CMV than other well-known infections and syndromes, including Down syndrome, fetal alcohol syndrome, spina bifida, and pediatric HIV/AIDS. "We are working to bring innovative vaccines to market that prevent and treat serious diseases. Through the acquisition of the Redvax innovative CMV vaccine platform and expertise we will seek to develop a vaccine to prevent a difficult disease that can have a devastating and lifelong impact on young children," said Dr Kathrin U Jansen, senior vice president and CSO Vaccine Research and Early Development for Pfizer. Mr Christian Schaub, MD, Redvax said, "We are pleased to have completed this deal with Pfizer, a global leader in vaccines. This represents an important step toward the development of a much needed vaccine for CMV, a disease that has a devastating impact on children and families. We believe that combining Redvax's assets with Pfizer's commitment, expertise and resources will significantly enhance the potential of developing this important vaccine." The financial details of the deal were not disclosed. ]]> <![CDATA[Bayer's receives FDA approval for Gadavist]]> https://biospectrumindia.com/news/95/4104/bayers-receives-fda-approval-for-gadavist.html https://biospectrumindia.com/news/95/4104/bayers-receives-fda-approval-for-gadavist.html Tue, 06 Jan 2015 15:25:46 +0530 Bayer HealthCare has announced that the US Food and Drug Administration (US FDA) has approved Gadavist (gadobutrol) injection for use with magnetic resonance imaging (MRI) in pediatric patients less than two years of age, including term neonates, to detect and visualise areas with disrupted blood brain barrier and/or abnormal vascularity of the central nervous system. Gadavist was previously approved for this use in patient populations over the age of two. The FDA's priority review was based on a study showing that the pharmacokinetic (PK) and safety profiles in pediatric patients less than two years of age were similar to that of older children and adults at standard dose (0.1 mmol/kg). "Gadavist is the first FDA-approved gadolinium-based contrast agent for pediatric patients under two years of age, including term neonates, and the approval provides guidance to physicians on how to use Gadavist in these young patients. With this label expansion, Gadavist is appropriate to use for MRI of the central nervous system at a standard dose of 0.1mmol/kg for patients of all ages - term neonates to adults," said Mr Christiane Pering, chief medical officer (CMO) and head of Innovation within Bayer HealthCare's Medical Care division. ]]> <![CDATA[New European consortium formed for advance development of Ebola candidate vaccine]]> https://biospectrumindia.com/news/95/4103/new-european-consortium-formed-for-advance-development-of-ebola-candidate-vaccine.html https://biospectrumindia.com/news/95/4103/new-european-consortium-formed-for-advance-development-of-ebola-candidate-vaccine.html Tue, 06 Jan 2015 14:17:45 +0530 A new European consortium has been formed including GSK and three leading research institutions to help further advance development of a candidate vaccine against Ebola, which is being co-developed by GSK and the US National Institutes of Health (NIH). The consortium is backed by funding of â‚¬15.1 million from the European Commission Directorate General for Research and Innovation as part of its dedicated Horizon 2020 program supporting research into treatments and vaccines for Ebola. The consortium also expects to receive an additional â‚¬1.4 million from the Swiss government. The funding is already helping to implement an ongoing trial of an Ebola candidate vaccine being carried out in 120 healthy adult volunteers in Lausanne, Switzerland. If the safety and immunogenicity data from this and other ongoing phase 1 trials are encouraging, the EC funding will enable the consortium to begin larger phase 2 trials in Africa, which could start as early as January 2015. These trials will evaluate the safety and ability of the GSK/NIH vaccine candidate to create an immune response against Ebola in adults and children, and will be carried out at established clinical study centers in West Africa, outside the most heavily-affected areas. It is anticipated that they will also investigate the effect of booster vaccination, if early stage booster trials underway at the University of Oxford are successful. Dr Moncef Slaoui, chairman, GSK Vaccines, said, "We welcome the generous support from the European Commission and appreciate how quickly they have worked to secure the research grant for our work. These partnerships are essential to accelerate development of the vaccine candidate in response to the Ebola outbreak we are seeing in West Africa." Beyond this 'EbolaVac' project, GSK is working with the WHO, regulators and other stakeholders to prepare for efficacy trials in Ebola affected countries including Sierra Leone and Liberia, should the phase 1 trials be successful. Further work continues to determine how and when near-term supplies of the Ebola candidate vaccine could be made available for targeted vaccination of additional health care workers and other people at high risk of infection in the affected countries, where the impact would be most likely to limit the further spread of the epidemic. Its future use in mass vaccination campaigns will depend on whether the vaccine candidate provides protection against Ebola without causing significant side- effects and how quickly large enough quantities can be made. The vaccine consists of a single Ebola virus protein, which belongs to the Zaire strain circulating in West Africa, engineered in a chimpanzee adenovirus vector. As it does not contain infectious Ebola virus material, it cannot cause a person who is vaccinated to become infected with Ebola, but should generate immune responses aimed at protecting subjects when exposed to the Ebola virus. ]]> <![CDATA[BMS, Calibr to co-develop anti-fibrotic therapies]]> https://biospectrumindia.com/news/95/4089/bms-calibr-to-co-develop-anti-fibrotic-therapies.html https://biospectrumindia.com/news/95/4089/bms-calibr-to-co-develop-anti-fibrotic-therapies.html Tue, 06 Jan 2015 13:57:15 +0530 Bristol-Myers Squibb (BMS) and the California Institute for Biomedical Research (Calibr) announced they have entered into a worldwide research collaboration to develop novel small molecule anti-fibrotic therapies, and an exclusive license agreement that allows BMS to develop, manufacture and commercialize Calibr's preclinical compounds resulting from the collaboration. The financial terms of the agreement were not disclosed. "Bristol-Myers Squibb's collaboration with Calibr further strengthens our specialty portfolio and advances the company's fibrotic diseases pipeline with the addition of this promising program," said Dr Carl Decicco, head of discovery, R&D, BMS. "Calibr's innovative discovery program in fibrosis represents an opportunity to develop new treatment approaches for patients." "Progressing our small molecule anti-fibrotic program toward the clinic represents a critical step in our mission to deliver therapies for unmet medical needs to patients," said Dr Peter G Schultz, institute director & founder, Calibr. "We are delighted to accelerate these efforts by partnering with BMS." Identifying novel medicines to halt or slow the progression of fibrotic disease and improve upon the current standard of care is a key part of BMS's R&D strategy. Calibr, an independent, not-for-profit organization established to accelerate the translation of basic biomedical discoveries into innovative new medicines, brings to the collaboration substantial expertise in identifying and optimizing small molecules with anti-fibrotic activity through its high-throughput screening, target identification, and preclinical drug discovery infrastructure. BMS and Calibr anticipate the transaction closure during the first quarter of 2015. Closing of the transaction is subject to customary closing conditions, including clearance under the Hart-Scott-Rodino Antitrust Improvements Act. ]]> <![CDATA[Health minister reviews H1 Influenza situation]]> https://biospectrumindia.com/news/95/4398/health-minister-reviews-h1-influenza-situation.html https://biospectrumindia.com/news/95/4398/health-minister-reviews-h1-influenza-situation.html Tue, 06 Jan 2015 13:56:00 +0530 In a high powered meeting with senior officers of the department of health and family welfare, Health Research, AIIMS, Safdurjung, Dr RML Hospital, NCDC and officers from government of Delhi and Ghaziabad, the union minister for health and family welfare, Mr JP Nadda reviewed the state of preparedness and action taken to deal with H1N1influenza cases. The health minister stated that seasonal influenza cases are reported every year between Jan-March and decline immediately after the winter season is over. The bout of H1N1 during this period is that of seasonal influenza, the Minister stated. The Health Minister has stated that while there is no cause to panic, the central and state governments should be well prepared. He directed the central and states government to stock up on emergency requirements of medicine Oseltamivir, even though the centre and states have procured the same for their respective use. The health minister emphasised on the states having adequate quantity of personal protective equipment for healthcare workers, as also diagnostic facilities required for testing H1N1 samples should be ensured. Mr Nadda has advised that the Integrated Disease Surveillance Program (IDSP) network should continue comprehensive and prompt reporting so that the districts/ states requiring more attention can be identified. The Health Minister has advised that the general public should take the necessary precaution such as covering ones mouth during coughing and sneezing, washing one's hands and avoid coming in touch with anyone who is exhibiting symptoms of the seasonal flu. Present during the meeting were Shri Lov Verma, Secretary (H&FW); Dr Jagdish Prasad, DGHS; Dr V M Katoch, Secretary (Health Research); Dr BD Athani, Special DGHS; Dr H K Kar, MS, Dr RML Hospital; Dr PK Julka, Dean, AIIMS; Shri Sudhansh Pant, Jt Secretary, Dept. of Pharmaceuticals and senior offices of the Ministry of Health & Family Welfare and NCDC. ]]> <![CDATA[ICAR Showcases Technologies at Pride of India Expo]]> https://biospectrumindia.com/news/95/4050/icar-showcases-technologies-at-pride-of-india-expo.html https://biospectrumindia.com/news/95/4050/icar-showcases-technologies-at-pride-of-india-expo.html Tue, 06 Jan 2015 12:38:25 +0530 ICAR has organized an informative and attractive pavilion giving a glimpse of recent technologies that have the potential for wide spread use by the farming community and related industries. The pavilion also focuses on some of the recent achievements in the field of agricultural research and education along with initiatives that have been taken to make agriculture more yielding and profitable. Well designed posters and live samples are attracting a large number of visitors including students, young researchers and farmers. Visitors are taking keen interest in pulses, cotton and fisheries sectors by making queries, which are being responded to by respective scientists. The mega exposition is organized at the MMRDA Grounds, Bandra-Kurla Complex in Mumbai to exhibit cutting-edge technologies, R&D initiatives, schemes and achievements of leading public and private sector scientific and educational institutions including government departments. Indian Science Congress (3-7 January, 2015) is being hosted by the University of Mumbai in which a large number of scientists from India and abroad, representatives from industries and government organizations, students, and NGOs are participating. (Source: ICAR-Directorate of Knowledge Management in Agriculture (DKMA), New Delhi) ]]> <![CDATA[Jubilant receives approval for 2 generic drugs]]> https://biospectrumindia.com/news/95/4060/jubilant-receives-approval-for-2-generic-drugs.html https://biospectrumindia.com/news/95/4060/jubilant-receives-approval-for-2-generic-drugs.html Tue, 06 Jan 2015 12:15:00 +0530 Jubilant Life Sciences has received Abbreviated New Drug Application (ANDA) final approval from the US Food and Drug Administration (US FDA) for Mycophenolate Mofetil USP, 250 mg Capsules and 500 mg Tablets (from its US subsidiary, Jubilant Cadista Pharmaceuticals Inc.) and Rizatriptan Tablets 5 mg and 10 mg (from its Indian subsidiary, Jubilant Generics Ltd.). Mycophenolate Mofetil USP, 250 mg Capsules and 500 mg Tablets is the generic version of Cellcept (of Roche), an immunosuppressant which is used to help prevent organ rejection in transplants. The current annualized US market size for Mycophenolate Mofetil USP, 250 mg Capsules and 500 mg Tablets as per IMS is $245 Million. Rizatriptan Tablets 5 mg and 10 mg is the generic version of Maxalt (of Merck), used for the treatment of migraine. The current annualized US market size for Rizatriptan Tablets 5 mg and 10 mg as per IMS is $70 Million. As on September 30, 2014, Jubilant Life Sciences had a total of 781 filings for formulations of which 322 have been approved in various regions globally. This includes 72 ANDAs filed in the US and 46 Dossier filings in Europe. ]]> <![CDATA[RPG appoints new additional director]]> https://biospectrumindia.com/news/95/3994/rpg-appoints-new-additional-director.html https://biospectrumindia.com/news/95/3994/rpg-appoints-new-additional-director.html Mon, 05 Jan 2015 14:35:41 +0530 RPG Life Sciences has informed BSE that its board has appointed Mr C T Renganathan as an additional director and as the MD for a term of 3 years with effect from January 02, 2015 subject to approval of the shareholders of the company and such other regulatory approvals as may be necessary. The company also has informed the stock exchange that Mr Ajit Singh Chauhan and Mr C Vinayaraghavan has resigned from the directorship of the company with effect from January 02, 2015 due to pre-occupation. ]]> <![CDATA[AstraZeneca gains EU approval]]> https://biospectrumindia.com/news/95/3965/astrazeneca-gains-eu-approval.html https://biospectrumindia.com/news/95/3965/astrazeneca-gains-eu-approval.html Mon, 05 Jan 2015 12:47:00 +0530 AstraZeneca has announced that the European Commission (EC) has granted marketing authorization for Lynparza (olaparib) capsules (400mg twice daily) as the first therapy for maintenance treatment of adult patients with platinum-sensitive relapsed BRCA-mutated (germline and/or somatic) high grade serous epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in complete response or partial response to platinum-based chemotherapy. Olaparib is a poly ADP-ribose polymerase (PARP) inhibitor that exploits tumour DNA repair pathway deficiencies to preferentially kill cancer cells. It is the first PARP inhibitor to be approved for patients with platinum-sensitive relapsed BRCA-mutated ovarian cancer. "We are delighted to be able to bring this much needed treatment to patients with BRCA-mutated ovarian cancer whose options are currently very limited. Today's approval marks a significant milestone in the development of the next generation of targeted medicines. We are committed to bringing new treatments to the patients who need them most and today's news marks only the first of what we hope will be a number of indications in which Lynparza has the potential to transform the lives of cancer patients, including those with breast, pancreatic and gastric cancers," said Mr Briggs Morrison, executive vice president, Global Medicines Development and chief medical oficer at AstraZeneca. The EC decision is applicable to all 28 EU member states as well as Norway, Iceland and Liechtenstein. The approval of olaparib was based on data from Study 191, a Phase II clinical trial that evaluated its efficacy and safety compared to placebo in platinum-sensitive relapsed high grade serous ovarian cancer patients. The study showed that olaparib maintenance therapy significantly prolonged progression free survival (PFS) compared with placebo in patients with BRCA-mutated ovarian cancer. ]]> <![CDATA[Protecting susceptible populations from chemical contaminants in food]]> https://biospectrumindia.com/views/95/3947/protecting-susceptible-populations-from-chemical-contaminants-in-food.html https://biospectrumindia.com/views/95/3947/protecting-susceptible-populations-from-chemical-contaminants-in-food.html Mon, 05 Jan 2015 11:44:45 +0530 The following article has been penned by Dr Fitzpatrick, appearing in the FDA Voice Blog: Anyone who regularly eats food containing low levels of certain chemical contaminants may be adversely affected over time. But some groups of people are more sensitive to chemical contaminants than others and thus are more likely to be harmed by long-term exposure. We call these groups "susceptible populations." The FDA's charge to ensure the safety of the food supply is not limited to the protection of the general public. We also have a responsibility to protect susceptible populations. Pregnant women, infants, young children, and older adults have long been recognized as susceptible populations by the scientific community. In addition, people with cancer, diabetes, HIV/AIDS and transplant recipients may have weakened immune systems and thus may also be more vulnerable. In short, these groups may be at greater risk from a given amount of a chemical contaminant because of their age, genetics, sex, or health status. Committed to protect susceptible populations as best we can, the FDA convened its Food Advisory Committee on December 16-17, 2014, to help shape our efforts to understand when and how risk assessments should integrate concern for susceptible populations. Conducted and used by regulators, risk assessments are one of the most objective and scientific ways to understand the potential adverse health effects of chemical contaminants in the food we eat. They help regulators apply science in policy and decision-making. Think of them as a foundation for risk management, a bridge between data and decisions. At times, however, susceptible populations may require special consideration. They may even warrant separate risk assessments under certain circumstances. If we evaluate their risk with the same broad brush that we apply to the general population, we might miss certain realities. In pregnant women, for example, metals like cadmium, lead and arsenic can cross the placenta and may harm the fetus while its neurological and immune systems are in their earliest stages of development. Similarly, senior citizens may have nutritional deficiencies or cardiovascular problems that make them more susceptible to certain contaminants. We asked difficult questions of the Food Advisory Committee. To paraphrase a few, we asked what factors the FDA should use to define a susceptible population, what data and level of confidence are needed to initiate a separate assessment for any given susceptible population, and whether there are subpopulations or life stages of particular concern. We also asked several technical questions. My colleagues and I hope to make meaningful inroads toward better understanding the risks faced by susceptible populations through our risk assessments, in part with the committee's help. We are confident that we are on the right track. In fact, our effort aligns with a recent report by the National Academy of Sciences (on inorganic arsenic), which suggests that, depending on the chemical, separate risk assessments may be warranted for certain susceptible populations. We will study the committee's advice to consider how we can best incorporate susceptible populations into our risk assessments. Ultimately, we know that it might not always make sense to take a "one-size-fits-all" approach when it comes to food safety. ]]> <![CDATA[Need to have clear regulatory framework : PM Modi]]> https://biospectrumindia.com/news/95/3932/need-to-have-clear-regulatory-framework-pm-modi.html https://biospectrumindia.com/news/95/3932/need-to-have-clear-regulatory-framework-pm-modi.html Mon, 05 Jan 2015 10:49:00 +0530 While inaugrating the Indian Science Congress in Mumbai on January 03, 2015, the prime minister, Mr Narendra Modi appreciated the role of scientists. In his words, " I feel humbled by the work that scientists do. And, I find science and technology an invaluable ally in governance and development." Mr Modi also mentioned the role of science in ancient Indian culIture and said that it is a search driven by the belief in what our Vedas described as, Satye Sarvam Pratisthanam - Everything is established in Truth. "Science and technology has helped reduce poverty and advance prosperity; fight hunger and improve nutrition; conquer diseases, improve health and give a child a better chance to survive; connect us to our loved ones and the world; spread education and awareness; and, given us clean energy that can make our habitat more sustainable," added Mr Modi. Modi also talked about the higher level of scientific involvement in diplomatic relations. He mentioned that as a PM, he placed agriculture, biotechnology and nanoscience on focus during his talks with leaders while travelling abroad. Modi also talked about importance of science in building great economy. "A nation`s progress and its human development are linked to science and technology. In more recent times, China`s emergence as the second biggest global economy is in parallel to its rise to the second place in science and technology activities," said the prime minister. In his inaugural speech, PM Modi asked scientists to make agriculture more resilient and yield more; to develop appropriate and affordable technologies for rural areas. At the same time, he asked them to help in preserving the biodiversity; and keep environment clean. Modi emphasized on methods to improve healthcare and develop medicines and medical devices that is within the reach of poorest. He asked researchers to make clean energy affordable and its use more efficient. "Too often, a discussion on science and technology is reduced to a question of budgets. It is important; and I am confident that it will continue to grow. But, our own achievements have shown that very often a need and vision and passion are more important than resource for success," said Modi on the references to miniscule allocation of funds. Modi owned the responsibility of his government as major source of science and technology efforts in the country. "When I speak of ease of doing business in India, I also want to pay equal attention to the ease of doing research and development in India. Funding proposals must not take too long to clear; meeting application requirement should not become more complex than research; approval process should not become a deterrent for international conference; and, our scientific departments must have flexibility of funding decisions based on the uncertainties inherent in research activities. "We want our scientists and researchers to explore the mysteries of science, not of government procedures. We want them to consider publications, not government approvals, to be the epitome of their success," added the prime minister. We must also have clear regulatory policies for research and development in areas like biotechnology, Nano-Science, agriculture and clinical research. We should ensure that our strong intellectual property regime continues to work effectively and provides the right balance between private incentives and social good. Further, not just scientific departments, but every other department in the Government should see how to apply science and technology and promote research to improve their work. Each should have an officer focusing on science and technology relating to its area of work; and, allocate a percentage of its budget for such activities. We have begun this experience with Space technology. Investments in science and technology activities should also become part of the expenditure on corporate social responsibility - to be funded directly or through an autonomous fund. We also need to foster a strong culture of collaboration between institutions and across disciplines to take advantage of developments, innovations and expertise in diverse areas. My impression is that this is far from the ideal in India Prime minister assured that he will ask his ministries to make collaborations a critical requirement for their institutions and for supporting funding requests for research. "We have to place the university system at the cutting edge of the research and development activities in the country. Our investments in science and technology are far too concentrated in the agencies of the Central Government and must become more broad-based. Our universities must be freed from the clutches of excessive regulation and cumbersome procedures. They must have a higher degree of academic freedom and autonomy; and, there should be as much emphasis on research as on teaching. In turn, the universities must also subscribe to the highest academic and research standards and accountability." Modi asked the industry to step up investments in science in its own interest. India`s own pharmaceutical industry has carved out a place for itself in the world, because it invests significantly in research, he said. "Indeed, our long term global competitiveness will depend not on replicating what others have done, but through a process of sustained development and innovation. There is a growing trend of international collaboration in research and development, not just among business enterprises, but equally among researchers and scholars at universities and laboratories. We should take full advantage of this." ]]> <![CDATA[Yoga can cure cardiovascular disease: study]]> https://biospectrumindia.com/news/95/5683/yoga-can-cure-cardiovascular-disease-study.html https://biospectrumindia.com/news/95/5683/yoga-can-cure-cardiovascular-disease-study.html Sat, 03 Jan 2015 11:06:00 +0530 A systematic review and meta-analysis of randomised controlled trials has concluded that yoga can be a potential therapy for cardiovascular disease and metabolic syndrome. The study is published in European Journal of Preventive Cardiology. In the study, Out of 1,404 records, 37 randomised controlled trials were included in the systematic review and 32 in the meta-analysis. Compared to non-exercise participants, yoga showed significant improvement for body mass index, systolic blood pressure, low-density lipoprotein cholesterol, and high-density lipoprotein cholesterol. Significant changes were seen in body weight, diastolic blood pressure, total cholesterol, triglycerides and heart rate but not fasting blood glucose. According to the authors, "This review helps strengthen the evidence base for yoga as a potentially effective therapy for such conditions. The results support earlier reviews on the positive benefits of yoga for cardiovascular disease prevention." However, no significant difference was found between yoga and exercise. The team concluded that there is promising evidence of yoga on improving cardio-metabolic health. ]]> <![CDATA[Arsenic in water good for breast cancer?]]> https://biospectrumindia.com/news/95/4413/arsenic-in-water-good-for-breast-cancer.html https://biospectrumindia.com/news/95/4413/arsenic-in-water-good-for-breast-cancer.html Sat, 03 Jan 2015 10:12:00 +0530 Researchers from the University of California (UC) Berkeley and the Pontifical Catholic University of Chile have linked arsenic to a 50 percent drop in breast cancer deaths. The researchers looked at the results of breast cancer mortality data from a region in Chile where residents were inadvertently exposed to high levels of arsenic, a naturally occurring element found in many minerals. Instead of an increase in mortality, as with many other cancer sites, the study found that breast cancer deaths were cut in half during the period that coincided with high arsenic exposure. The effect was more pronounced among women under age 60, with mortality in these women reduced by 70 percent. "What we found was astonishing. We have been studying the long-term effects of arsenic in this population for many years, focusing on increased disease and mortality attributed to the historical exposure to arsenic in this population," said study lead author Dr Allan Smith, UC Berkeley professor of epidemiology and director of the Arsenic Health Effects Research Program. The research is published in the journal EBioMedicine. ]]> <![CDATA[Genentech receives FDA approval for Gazyva]]> https://biospectrumindia.com/news/95/3177/genentech-receives-fda-approval-for-gazyva.html https://biospectrumindia.com/news/95/3177/genentech-receives-fda-approval-for-gazyva.html Sat, 03 Jan 2015 10:02:00 +0530 The sBLA adds to the label data from Stage 2 of the CLL11 study showing significant improvements with Gazyva plus chlorambucil across multiple clinical endpoints when compared head-to-head with Rituxan (rituximab) plus chlorambucil. The approval includes complete response (CR) and minimal residual disease (MRD) data from Stage 2 of the study. Additionally, overall survival (OS) data was added from Stage 1 of the study comparing Gazyva plus chlorambucil to chlorambucil alone. "Gazyva is the first and only medicine to significantly help people live without their disease worsening when combined with chlorambucil compared to Rituxan and chlorambucil in people with previously untreated chronic lymphocytic leukemia," said Dr Sandra Horning, chief medical officer and head of global product development. "These new data enhance our understanding of the disease and its treatment, and this approval affirms an important treatment option for people with this difficult-to-treat disease." ]]> <![CDATA[Strengthening emergency preparedness can save lives in mega disasters: WHO]]> https://biospectrumindia.com/news/95/3882/strengthening-emergency-preparedness-can-save-lives-in-mega-disasters-who.html https://biospectrumindia.com/news/95/3882/strengthening-emergency-preparedness-can-save-lives-in-mega-disasters-who.html Fri, 02 Jan 2015 15:01:18 +0530 "The mega disaster of 26 December 2004, when massive tsunami waves hit six countries in the Region, causing death, destruction and devastation of unbelievable scale, put the spotlight on the need for being prepared to respond to the most unexpected disaster anywhere, anytime. Concerted efforts have since been made, and continue today, to phenomenally increase preparedness and response capacities," said Dr Poonam Khetrapal Singh, regional director WHO South-East Asia region. WHO South-East Asia Region has developed a set of Benchmarks for Emergency Preparedness and Response which includes standards, indicators and guided questions to measure what is in place for legal frameworks, plans, finance, coordination mechanisms, community capacities, capacity development and early warning. Member countries are using the WHO benchmarks for capacity development and assessment for risk management in the health sector. WHO has established the South-East Asia Regional Health Emergency Fund (SEARHEF) for rapid and predictable funding of emergencies. India, Indonesia, Maldives, Sri Lanka and Thailand continue to improve systems they set up with knowledge and tools developed through the lessons from the tsunami. Even countries in WHO South-East Asia Region, not affected by the tsunami in 2004, are doing so, using the same knowledge. WHO has been underscoring the importance of investing in health infrastructure that can withstand hazards and serve people in immediate need; the safety of health facilities and the readiness of health workers who treat those affected by emergencies. Health centres and staff are critical lifelines for vulnerable people in times of disaster. WHO has also been focusing on measuring preparedness - a sound basis for addressing risk - and identifying and addressing gaps for better emergency preparedness and response. The WHO Benchmarks and SEARHEF, established after the 2004 tsunami and other initiatives have served well. Disasters in recent years have demonstrated the enhanced response capacities of the Member countries such as during the massive earthquake in Indonesia on 11 April, 2012, which triggered a tsunami alert, ensuring timely evacuation and appropriate community and government response with minimal loss. ]]> <![CDATA[ SRF buys Dupont's pharma propellant business]]> https://biospectrumindia.com/news/95/3898/-srf-buys-duponts-pharma-propellant-business.html https://biospectrumindia.com/news/95/3898/-srf-buys-duponts-pharma-propellant-business.html Fri, 02 Jan 2015 13:14:57 +0530 SRF has signed an agreement to acquire US-based DuPont's medical pharmaceutical propellant business for $20 million in an all-cash deal, said reports. With the acquistion, the company acquires Global DuPont Dymel HFC 134a Pharma Business, will own its 'Dymel' brand and receive the technology and knowhow for setting up its own current Good Manufacturing Practices (cGMP) facility for manufacturing HFC 134a Pharma grade. DuPont will supply SRF with the product till the company's own production facility is approved. "This acquisition is in sync with our long-term strategy to move up the value chain and will enable us to enter the niche pharma product segment. The growth in the Metered Dose Inhalers (MDI) sector is expected to be reasonably robust in the years to come. This will also offer great synergy with our existing HFC plants going forward," said Mr Ashish Bharat Ram, managing director, SRF in a statement. ]]> <![CDATA[Opportinity for biomedical students to learn in Japan]]> https://biospectrumindia.com/news/95/4784/opportinity-for-biomedical-students-to-learn-in-japan.html https://biospectrumindia.com/news/95/4784/opportinity-for-biomedical-students-to-learn-in-japan.html Fri, 02 Jan 2015 12:52:51 +0530 The department of biotechnology (DBT) in collaboration with the National Institute of Advanced Industrial Science and Technology (AIST) has invited applications from researchers (Students in their second or third year of research and Young PIs) to visit the DBT- AIST International Laboratory for Advanced Bioinformatics (DAILAB) and contribute to ongoing research themes in cell-imaging and drug screenings using novel assays for disease therapeutics, stress and metabolic regulations, for a period of three months to one year. This will provide training for research, living and working in Japan. Selected applicants will be supported for their travel, accommodation and living as per AIST rules. Interested students should send application including the following information in English to s-kaul@aist.go.jp or y-ohmiya@aist.go.jp The applicants will have to send their detailed photo CV, letter of recommendation from the mentor, NOC (No Objection Certificate) from the head of their parent institute and one page synopsis on points including the reason for doing research; main curiosity and the major question seeking answer by research and level of satisfaction being a researcher as a career. ]]> <![CDATA[NITI Aayog replaces the Planning commission]]> https://biospectrumindia.com/news/95/6322/niti-aayog-replaces-the-planning-commission.html https://biospectrumindia.com/news/95/6322/niti-aayog-replaces-the-planning-commission.html Fri, 02 Jan 2015 12:33:17 +0530 The union government has on December 01, 2014 announced the establishment of NITI Aayog (National Institution for Transforming India), as a replacement for the Planning Commission. This comes after extensive consultation across the spectrum of stakeholders, including state governments, domain experts, and relevant institutions. As per the press release issued by the Prime Minister's Office, the NITI Aayog will create a knowledge, innovation and entrepreneurial support system through a collaborative community of national and international experts, practitioners and partners. It will offer a platform for resolution of inter-sectoral and inter-departmental issues in order to accelerate the implementation of the development agenda. In addition, the think tank will monitor and evaluate the implementation of programmes, and focus on technology upgradation and capacity building. The focus on the issues that were serving as impedement to industry's growth is surely the way forward. It is expected that the industry associations would react favorably to the decision. NITI Aayog will aim to accomplish the following objectives and opportunities: An administration paradigm in which the Government is an "enabler" rather than a "provider of first and last resort; Progress from "food security" to focus on a mix of agricultural production, as well as actual returns that farmers get from their produce. Ensure that India is an active player in the debates and deliberations on the global commons. Leverage India`s pool of entrepreneurial, scientific and intellectual human capital. Incorporate the significant geo-economic and geo-political strength of the Non-Resident Indian Community. Use urbanization as an opportunity to create a wholesome and secure habitat through the use of modern technology. Use technology to reduce opacity and potential for misadventures in governance. The NITI Aayog aims to enable India to better face complex challenges, through the following: Leveraging of India`s demographic dividend, and realization of the potential of youth, men and women, through education, skill development, elimination of gender bias, and employment. Elimination of poverty, and the chance for every Indian to live a life of dignity and self-respect. Reddressal of inequalities based on gender bias, caste and economic disparities. Integrate villages institutionally into the development process. Policy support to more than 50 million small businesses, which are a major source of employment creation and safeguarding of our environmental and ecological assets ]]> <![CDATA[Novartis' Signifor receives FDA approval ]]> https://biospectrumindia.com/news/95/3878/novartis-signifor-receives-fda-approval-.html https://biospectrumindia.com/news/95/3878/novartis-signifor-receives-fda-approval-.html Thu, 01 Jan 2015 16:47:10 +0530 Novartis has announced that the US Food and Drug Administration (US FDA) has approved Signifor long-acting release(LAR)(pasireotide), a next-generation somatostatin analog (SSA) for injectable suspension and intramuscular use. It is used for the treatment of patients with acromegaly who have had an inadequate response to surgery and/or for whom surgery is not an option. Signifor LAR has been studied and found effective in both medically naÃ¯ve patients with acromegaly who have had prior surgery or for whom surgery was not an option, as well as patients whose disease is not fully controlled on first generation SSAs. Acromegaly is a rare, debilitating endocrine disorder caused by the excess production of growth hormone (GH) and insulin-like growth factor-1 (IGF-1). This FDA approval was based on two multicenter Phase III studies, C2305 and C2402, which respectively examined medically naÃ¯ve patients who have had prior surgery or for whom surgery was not an option and patients with acromegaly inadequately controlled on first generation SSAs. In both studies, higher rates of full biochemical control (defined as mean GH level < 2.5mcg/L and normal IGF-1 levels) were achieved with Signifor LAR compared to a first generation SSA. "The FDA approval of Signifor LAR for acromegaly marks an important day for physicians and patients living with difficult-to-treat pituitary conditions and underscores our continued commitment to helping patients manage rare diseases. We are pleased that a new treatment option is now available to help address the serious impact of uncontrolled acromegaly, and are optimistic about providing this much needed treatment to other patients worldwide in the near future," said Mr Bruno Strigini, president, Novartis Oncology. ]]> <![CDATA[Hospira gets US FDA nod for Dyloject injection]]> https://biospectrumindia.com/news/95/3997/hospira-gets-us-fda-nod-for-dyloject-injection.html https://biospectrumindia.com/news/95/3997/hospira-gets-us-fda-nod-for-dyloject-injection.html Thu, 01 Jan 2015 14:50:00 +0530 The US Food and Drug Administration (US FDA) has approved Hospira's Dyloject (diclofenac sodium) injection, a proprietary nonsteroidal anti-inflammatory drug (NSAID) analgesic. Dyloject is indicated for use in adults for the management of mild to moderate pain and for the management of moderate to severe pain alone or in combination with opioid analgesics. "In today's healthcare environment, pain management and patient satisfaction are important to hospitals. As a result, various medical organisations are now recommending a multi-modal approach to pain control in an effort to minimise the use of opioids", said Mr Sumant Ramachandra, senior vice president and chief scientific officer, Hospira. "Hospira's Dyloject will be a complementary addition to our existing portfolio of acute-care drugs, providing clinicians an additional non-opioid option that can be administered quickly and conveniently to treat pain," he added. Dyloject's approval is based on two double-blind, placebo and active-controlled, multiple-dose clinical trials of adult patients with postoperative pain. In both trials, intravenous (IV) morphine was permitted as rescue medication for pain management. . ]]> <![CDATA[Suven Life Sciences secures patents]]> https://biospectrumindia.com/news/95/4085/suven-life-sciences-secures-patents.html https://biospectrumindia.com/news/95/4085/suven-life-sciences-secures-patents.html Thu, 01 Jan 2015 09:35:00 +0530 Suven Life Sciences has announced the grant of three product patent. One each from Eurasia (020227), Japan (5540099) and Mexico (319429) corresponding to the New Chemical Entities (NCEs) for the treatment of disorders associated with Neurodegenerative diseases. These Patents are valid through 2029. The granted claims of the patents include the class of selective 5-HT compounds discovered by Suven and are being developed as therapeutic agents and are useful in the treatment of cognitive impairment associated with neurodegenerative disorders like Alzheimer's disease, Attention deficient hyperactivity disorder (ADHD), Huntington's disease, Parkinson, and Schizophrenia. With these new patents, Suven has a total of thirteen granted patents from Eurasia, twelve granted patents from Japan and seventeen product patents from Mexico. These granted patents are exclusive intellectual property of Suven and are achieved through the internal discovery research efforts. Products out of these inventions may be out-licensed at various phases of clinical development like at Phase-I or Phase-II. "We are very pleased by the grant of these patents to Suven for our pipeline of molecules in CNS arena that are being developed for cognitive disorders with high unmet medical need with huge market potential globally," said Mr Venkat Jasti, CEO of Suven. ]]> <![CDATA[Janssen amends agreement with Gilead]]> https://biospectrumindia.com/news/95/5689/janssen-amends-agreement-with-gilead.html https://biospectrumindia.com/news/95/5689/janssen-amends-agreement-with-gilead.html Wed, 31 Dec 2014 13:05:58 +0530 Gilead Sciences has announced an expansion to its agreement with Janssen R&D Ireland for the development and commercialisation of a new once-daily single tablet regimen containing Gilead's tenofovir alafenamide (TAF) and emtricitabine, and Janssen's rilpivirine. The original agreement was established in 2009 for the development and commercialization of Complera, marketed as Eviplera in the European Union, which combines tenofovir disoproxil fumarate, emtricitabine and rilpivirine in a once-daily tablet. Gilead will initiate Phase three studies of emtricitabine/rilpivirine/TAF in the coming months. Pending the product's approval, Gilead will be responsible for the manufacturing, registration, distribution and commercialization of the regimen in most countries, while Janssen will distribute in approximately 17 markets. "We believe that TAF's efficacy and safety advantages may make it a strong backbone of new fixed-dose combinations and single tablet regimens. Gilead is pleased to continue its collaboration with Janssen to bring improved treatment options to patients living with HIV," said Dr Norbert Bischofberger, executive vice president, R&D and chief scientific officer, Gilead Sciences. Under the amended agreement, Janssen will be responsible for further development of the regimen and, subject to regulatory approval, the manufacturing, registration, distribution and commercialization of the product worldwide. ]]> <![CDATA[Novo Nordisk receives FDA approval for its obesity drug]]> https://biospectrumindia.com/news/95/5629/novo-nordisk-receives-fda-approval-for-its-obesity-drug.html https://biospectrumindia.com/news/95/5629/novo-nordisk-receives-fda-approval-for-its-obesity-drug.html Wed, 31 Dec 2014 12:24:00 +0530 Novo Nordisk has announced that the US Food and Drug Administration (US FDA) has approved the New Drug Application (NDA) for Saxenda (liraglutide 3 mg), the first once-daily human glucagon-like peptide-1 (GLP-1) analogue for the treatment of obesity. Saxenda is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with obesity (BMI =>30 kg/m2) or who are overweight (BMI =>27 kg/m2) with at least one weight-related comorbidity such as type 2 diabetes and cardiovascular disease. "Many people with obesity suffer from comorbidities. Saxenda has the potential to help some of these people achieve and maintain a clinically significant weight loss and improve their weight-related comorbidities," said Mr Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk. Novo Nordisk expects to launch the drug in the US in the first half of 2015. ]]> <![CDATA[Stem cell donor registry soon]]> https://biospectrumindia.com/news/95/6547/stem-cell-donor-registry-soon.html https://biospectrumindia.com/news/95/6547/stem-cell-donor-registry-soon.html Wed, 31 Dec 2014 11:06:39 +0530 It has been reported that the official database on stem cell donors and recipients to be created by health ministry utilizing the service of te All India Institute of Medical Sciences (AIIMS). The registry would be the first government registry in the country. As per suggested proposal that is being evaluated currently, all district hospitals would be enrolled in the first phase to seek stem cell details from across the country. Once a stem cell donor registry was in place, a willing donor could be contacted and one could coordinate easily. In addition to the donor registry, the ministry was also looking at creating facilities for human leucocyte antigen (HLA) typing. HLA-typing, a process conducted for matching donors and recipients of stem cell is necessary to minimise stem cell transplant rejection according to experts. Stem cell therapy has been found to be effective in various blood disorders and in treatment of cancer and is widely used in bone marrow transplantation. ]]> <![CDATA["Pharma companies must shun practice of gifts to medicos"]]> https://biospectrumindia.com/news/95/5608/pharma-companies-must-shun-practice-of-gifts-to-medicos.html https://biospectrumindia.com/news/95/5608/pharma-companies-must-shun-practice-of-gifts-to-medicos.html Wed, 31 Dec 2014 11:06:00 +0530 The union minister for health and family welfare, Mr JP Nadda has emphasised on the need for medical ethics for doctors while delivering the keynote address at the 89th National Conference "IMA NATCON 2014", organized by the Indian Medical Association, at Ahmedabad recently. The health minister decried the prevalent practice of giving gifts to doctors by pharma companies. He called upon the medicos to shun this practice. The health minister stated that India faces the dual burden of communicable and non-communicable diseases unlike many other countries which have to address only one of these. The minister urged the IMA to encourage doctors to serve in the rural areas. Mr Nadda spoke on the key initiatives taken by the government such as Beti Bachao, Beti Padhao (BBBP) scheme which will be rolled out in 100 gender critical districts, and the Swachch Bharat Abhiyan. The Health Minister noted that the time has come where hygiene and cleanliness needs to be made a part of our civic consciousness. There is an undeniable and strong connection between cleanliness and overall health and well-being. The country cannot aspire to meet the goals for 'health for all' in absence of clean and hygienic surroundings, the minister said. He urged the doctors to use their influence with the patients to spread consciousness of cleanliness and hygiene among them. Minister informed that the National Health Policy will be placed in public domain to invite comments and suggestion from all stakeholders. He welcomed suggestions and insights of the medical fraternity for enriching the National Health Policy. He highlighted the several new initiatives taken by the government like launch of the country's first Mental health Policy. ]]> <![CDATA[DBT seeks nominations for "Career Development Award 2104"]]> https://biospectrumindia.com/news/95/5604/dbt-seeks-nominations-for-career-development-award-2104.html https://biospectrumindia.com/news/95/5604/dbt-seeks-nominations-for-career-development-award-2104.html Wed, 31 Dec 2014 11:05:26 +0530 The Department of Biotechnology (DBT) has invited nominations of scientists who are engaged in basic and aplied research in Biological Sciences including biotechnology, agricultural, medical, and environmental sciences and have made outstanding contributions in research with potential for aplication or product and technology development, for 'National Bioscience Award for Career Development for the year 2014'. The award recognizes outstanding contributions of young scientists below 45 years of age in basic and applied research in the areas of biosciences and biotechnology including agricultural, biomedical and environmental sciences with potential for aplication/product and technology development and to provide grant for research for their career development. Upto 10 awards subject to the availability of suitable candidates will be given every year. Each award caries a cash prize of Rs 2 lakh along with project research grant of Rs 15 lakh. Also, Rs 5 lakh per year grant is available for a period of three years for career development alongwith a citation. ]]> <![CDATA[Enhancing agricultural output on top priority says RM Singh]]> https://biospectrumindia.com/news/95/5599/enhancing-agricultural-output-on-top-priority-says-rm-singh.html https://biospectrumindia.com/news/95/5599/enhancing-agricultural-output-on-top-priority-says-rm-singh.html Wed, 31 Dec 2014 11:04:27 +0530 Speaking to media on December, 30 at New Delhi, the union agriculture minister, Mr Radha Mohan Singh emphasized that government has put the increase in crop production and productivity on top priority. He further mentioned that the govrrnment has a clear perception about holistic and sustainable agriculture. The minister also highlighted last six months achievements to make farmer oriented policy. Rs 886 crore for the National E - governance scheme in agri sector. Technical support to farmers has been a problem area and hence to tackle it, the ministry has set up 913 farm machinery banks. Farmers can take equipment on hire basis from these banks. An amount of Rs 1,345 crore has been allocated for equipment in 2014 - 15 as compared with Rs 1,213 in 2013 - 14. Mr Singh revealed that there has been increase of subsidy amount to Rs 300 per hectare from Rs 100 per hectare. The Agriculture minister hopes that the new initiatives will lead to increased agricultural contribution in country's overall GDP. The minister also highlighted last six months achievements to make farmer oriented policy. The Government have established a special fund of Rs 500 crore as an important initiative. With the setting up of this Price Stabilization Fund, farmers will be able to get fair price of their products. We have called upon the State Governments to amend the APMC Act so that farmers may sell their fruits and vegetables direct to consumers. So far, 12 States have agreed to our suggestion. States have been requested to set up Kisan Mandis and a kisan mandi is being established in Delhi. The entire country being connected through e-marketing under Agri Tech Infrastructure Fund. The Government have given in-principle approval to a scheme of traditional agricultural development. The Prime Minister's Krishi Sichai Yojana is under finalization. We also have a plan to make comprehensive amendments in the Cooperative Act and make available a 24-Hour exclusive TV Channel for farmers. We have also targeted to cover at least one family out of three families under Kisan Call Center. The Government have made several initiatives for development of Animal Husbandry, Dairy and Fisheries sector under the National Gokul Mission. An allocation of Rs.500 crore has been made to protect and promote the breed of Desi Cows. So far, projects of Rs 378 crore have been sanctioned and Rs 123 crore have been released during the current financial year. Under National Dairy Plan Phase-I from June to November 2014, 87 SP Projects has been sanctioned as compared to 41 SP Projects during the same period last year. During June-November, 2014, Rs 133.56 crore subsidy has been released under Dairy Entrepreneurship Development Scheme. National Livestock Mission has been made effective in the entire country. The Fisheries Guidelines have been simplified further. Fishing boats of 15 mtr. Size or more can enter Exclusive Economic Zone to catch fish. In case of death of fishermen, insurance amount has been increased from Rs1 lakh to Rs 2 lakhs. Sanction for housing for 830 fishermen under Fishermen Welfare Scheme has been issued. Government will adopt latest technologies to promote Blue Revolution in the country. Under Mission Blue Revolution and RKVY, Government plans to establish new breeding centres cages, manufacturing of marine cages and cold water fishing with a provision of Rs 157 crore. We aim to increase milk production to 150 million tonnes by 2016-17 and also organized dairy market will be extended. During the conference, Mr Singh mentioned that there will be definite results of all these initiatives taken by the Government in the time to come and there will be growth in agricultural sector and welfare of farmers will be promoted. He hoped that agriculture's contribution in GDP will touch newer heights with these initiatives. ]]> <![CDATA[Janssen, Sevion ink pact for antibody discovery]]> https://biospectrumindia.com/news/95/5110/janssen-sevion-ink-pact-for-antibody-discovery.html https://biospectrumindia.com/news/95/5110/janssen-sevion-ink-pact-for-antibody-discovery.html Tue, 30 Dec 2014 14:07:14 +0530 Sevion Therapeutics has announced a collaboration agreement with CNA Development, LLC, an affiliate of Janssen Pharmaceuticals to discover antibodies using Sevion's spatially addressed library platform. The collaboration facilitated by the Johnson & Johnson Innovation center in California will include discovery of antibodies against multiple targets in several therapeutic areas. Under the terms of the agreement, Sevion will receive an up-front payment and research support payments for activities conducted in collaboration with Janssen. For candidates licensed by Janssen, Sevion would be eligible to receive payments upon the achievement of certain development and commercial milestones potentially up to $125 million as well as low single digit royalties on product sales. According to Mr Ronald Martell, CEO, Sevion, "We are excited to collaborate with Janssen, a recognized leader in antibody development and commercialization. This partnership applies the Sevion platform for discovering unique antibodies against important therapeutic targets." Sevion's platform enables discovery of antibodies against proteins that cannot be easily purified in functional form. Sevion's addressed libraries allow screening directly on the cell surface, opening difficult transmembrane targets to antibody discovery. ]]> <![CDATA[Merck acquires OncoEthix]]> https://biospectrumindia.com/news/95/5039/merck-acquires-oncoethix.html https://biospectrumindia.com/news/95/5039/merck-acquires-oncoethix.html Tue, 30 Dec 2014 13:21:24 +0530 Merck has announced that it has acquired, through a subsidiary, OncoEthix, a Swiss-based biotechnology company specialising in oncology drug development. Through the acquisition, Merck has gained an investigational, novel oral BET (bromodomain) inhibitor, OTX015, which is currently in Phase 1b studies for the treatment of hematological malignancies and advanced solid tumors. "Oncology is a priority area of focus for Merck and the acquisition of OncoEthix supports our strategy to prioritize the development of innovative molecules with the potential to improve the treatment of advanced cancers," said Dr Roy Baynes, senior vice president, global clinical development, Merck Research Laboratories. He added, "The potential first-in-class oral BET inhibitor, OTX015, has demonstrated early promising activity in hematological cancers and strategically complements our broad immuno-oncology development program." According to Mr Bertrand Damour, chief executive officer, OncoEthix, "We are delighted that OTX015 will now be in the hands of Merck, a company with a successful track record of developing cutting-edge therapies. The acquisition underlines the promise that OTX015 has shown in the treatment of hematological malignancies, and the potential it has for the treatment of advanced solid tumors. We are confident that our transaction with Merck best positions OTX015 to be developed to its full potential in areas of high unmet medical need." Financial terms of the acquisition include an upfront payment of up to $110 million to OncoEthix. Additional milestone payments of up to $265 million are contingent upon certain clinical and regulatory events being achieved. ]]> <![CDATA[Eli Lilly and Adocia ink pact]]> https://biospectrumindia.com/news/95/5040/eli-lilly-and-adocia-ink-pact.html https://biospectrumindia.com/news/95/5040/eli-lilly-and-adocia-ink-pact.html Tue, 30 Dec 2014 13:16:21 +0530 Eli Lilly and Adocia has announced a worldwide licensing collaboration focused on developing an ultra-rapid insulin, known as BioChaperone Lispro, for treatment of type 1 and type 2 diabetes. BioChaperone Lispro relies on Adocia's proprietary BioChaperone technology and is currently in Phase Ib studies. Lilly and Adocia will develop BioChaperone Lispro with the goal of optimising glucose levels during and after meals. Potential benefits of BioChaperone Lispro include greater flexibility in the timing of insulin injections, lower variability of post-meal blood glucose elevations, lower rates of hypoglycemia and better overall glucose control. Under the terms of the agreement, Lilly is responsible for future development, manufacturing, and commercialization of BioChaperone Lispro. The total up-front and milestone payments could reach up to $570 million; Adocia will receive a total upfront fee of $50 million with the potential for future payments of up to $280 million if the product reaches certain development and regulatory milestones, and sales milestones up to $240 million, as well as tiered sales royalties. Lilly shall also reimburse Adocia for certain research and development expenses during the terms of the agreement. A concentrated formulation of BioChaperone Lispro is also part of the agreement. "An ultra-rapid acting insulin, if approved by regulators, could provide a new important treatment option for people with type 1 and type 2 diabetes," said Mr Enrique Conterno, president, Lilly Diabetes. He added, "An ultra-rapid acting insulin would be a natural fit in our growing portfolio." "It is a great day for Adocia and Lilly, a global leader in diabetes treatment, to initiate a new collaboration for the development of an innovative ultra-rapid formulation of insulin lispro. We consider Lilly a key collaborator on this project based on their extensive knowledge of insulin," said Mr Gerard Soula, president and CEO of Adocia. Adocia retains the right to develop and license its insulin programs unrelated to prandial ultra-rapid insulin. ]]> <![CDATA[DCGI warns hospital against false stem cell treatment promises ]]> https://biospectrumindia.com/news/95/3006/dcgi-warns-hospital-against-false-stem-cell-treatment-promises-.html https://biospectrumindia.com/news/95/3006/dcgi-warns-hospital-against-false-stem-cell-treatment-promises-.html Mon, 29 Dec 2014 14:29:54 +0530 In a letter dated December 11 and signed by the DCGI, Dr G N Singh the premier regulatory agency of India while issuing warning to the Pune based hospital has asked it to stop all the treatments. The DCGI had earlier issued a notice on November 21, 2014 seeking a reply within ten days from the hospital on the issue. But the respondent failed to give any reply during the stipulated timeline. The action came after a complaint had been filed against the hospital that various stem cell treatments with high costs for Cerebral Palsy, Stroke, Wilson's Disease and Spinal cord injury were being offered to the patients. The processing of bone marrow derived mono nuclear cells was claimed to fall under minimum manipulation category as per ICMR guidelines but it was reported that the hospital had no instrument provided which ensures aseptic processing and no documents were maintained as required in the Good Clinical Practices. Moreover, the patients were charged heavily for the treatment for period 2013 to September 2014. Keeping that in view, the DCGI had initiated an enquiry in the matter and the team investigating the same had reported that required permission was not obtained for the clinical trials of the disease conditions. It concluded that the hospital had violated the Drugs and Cosmetics Act 1940 and Drugs and Cosmetics Rule 1945 which has a bearing on the patient safety. ]]> <![CDATA[Torrent Pharma and Reliance Life Sciences tie-up]]> https://biospectrumindia.com/news/95/4125/torrent-pharma-and-reliance-life-sciences-tie-up.html https://biospectrumindia.com/news/95/4125/torrent-pharma-and-reliance-life-sciences-tie-up.html Mon, 29 Dec 2014 12:45:06 +0530 Ahmedabad-based Torrent Pharmaceuticals has announced that it has entered into an exclusive licensing agreement with Reliance Life Sciences for marketing three biosimilars in India - Rituximab, Adalimumab and Cetuximab. Under the terms of the agreement, Reliance Life Science will develop and supply these products to Torrent Pharma for a period of ten years after obtaining all necessary regulatory approvals. The company will manufacture these products at its facility in Navi Mumbai. Rituximab and Cetuximab cater to the oncology segment and are used in the treatment of various cancers like Leukaemia, Lymphoma, colorectal, head and neck cancers. Adalimumab is the most preferred therapy for the treatment of auto immune disorders like rheumatoid arthritis, psoriasis and IBD. The licensing agreement with Reliance Life Sciences is expected to significantly boost Torrent Pharma's presence in oncology and dermatology segments in the coming years. ]]> <![CDATA[Lupin gets US FDA nod]]> https://biospectrumindia.com/news/95/4106/lupin-gets-us-fda-nod.html https://biospectrumindia.com/news/95/4106/lupin-gets-us-fda-nod.html Mon, 29 Dec 2014 12:44:00 +0530 Lupin has announced that it has received the US Food and Drug Administration (US FDA) approval to market a generic version of ViiV Healthcare's Epivir Tablets, used in treating HIV infection. According to the company, it has received final approval for its Lamivudine tablets in strengths of 150 mg and 300 mg. Epivir tablets had annual US sales of $39.7 million as per IMS MAT September 2014 sales data. ]]> <![CDATA[Pharma, biotech cos low on VC radars]]> https://biospectrumindia.com/features/95/5611/pharma-biotech-cos-low-on-vc-radars.html https://biospectrumindia.com/features/95/5611/pharma-biotech-cos-low-on-vc-radars.html Sat, 27 Dec 2014 09:26:00 +0530 This is primarily driven by increasing per capita disposable income, rising urbanization and growing health awareness, rapidly shifting disease patterns from acute to chronic, and growth in domestic healthcare infrastructure. In the last two years, the healthcare and Life Sciences sectors have attracted over $2.3 billion worth of private equity (PE) investments, accounting for over 10 percent share of all PE investments done in India. The Indian healthcare and lifesciences sector continues to be among the top five destinations for private equity investors in India. Are VCs risk averse? "In my view, within the Life Sciences space, VCs are highly risk averse to novel drug discovery investments given the very high failure rates involved. Aside of this, most other segments in lifesciences including generics, contract manufacturing, IT, discovery services, and retail, have all faced active investments by VCs," opined Ms Visalakshi Chandramouli, Partner - Healthcare Fund (Private Equity), Tata Capital. There are also others who are willing to take calculated risks in an investment. "Good venture capitalists in lifesciences and in other areas are those who take thoughtful risks, but 'taking risk' alone is not a wise investment strategy. I agree that India doesn't have a well-developed ecosystem. This is partly a developmental issue. As we see companies delivering sound returns, there will be greater appetite for life sciences opportunities among venture firms," Mr Rajeev Mantri, executive director, Navam Capital, said optimistically. At times, it may totally depend on who the VCs are, what their mandate or philosophy is. Mr Vishal Gandhi, founder & CEO, BioRx Venture Advisors (BVA), commented, "It is important to find the right advisor so that the chances of raising the capital is more. One needs to appreciate the role of advisors and they are not risk averse. There are no businesses without risks provided there are appropriate mitigation strategies." There are other seed investment firms in India that have appetite to invest in early stage enterprises. "VCs generally enter after establishing proof-of-concept. We like to place riskier bets and understand the need of the hour for enterprises that are just starting out," emphasized Mr Sanjib Jha, CEO, IntelleGrow. Attracting VCs For start-ups to attract VC investments, it is imperative they clarify their abilities and timeline for achievement of proof-of-concept, and as well as the concept's scalability potential. According to Ms Padmaja Ruparel, president, Indian Angel Network, "It is vital to focus on building a venture because you want to do it. It should be a passion as that will make it a well differentiated, fast-growing company and you will ensure you execute and deliver well. If you do this, investors will come flocking!" Also, start-ups should build outstanding teams that can win investors' confidence. Mr Sanjib states that it is crucial to have a clear, five-year strategic model plan. "Put in a good team in place and invest in understanding your own abilities to deliver each year. Keep incorporating changes, given learning, even if it means going back to the whiteboard and starting from the scratch. If you stay honest to your model and plans, the VCs will be aligned," he advised. The Tata Capital Healthcare Fund (TCHF) targets long-term capital appreciation through PE growth-capital investments in healthcare companies that have a significant proportion of their operations in, or revenues from India. Mr Vishal advises start-ups to do their homework well and understand what VCs are looking for. "VCs are there to support them financially and they need to be highly proactive in searching the right VCs because not everyone is willing to invest their money. Most of the time VCs do their due diligence in investing in start-ups. This diligence should be among entrepreneurs as well before they reach out to VCs. That's where professional advisors bridge the gap," he commented. Factors driving investments Mr Sanjib points that investors' assessment model lays a lot of stress on entrepreneurs, their ability to deliver and operationalize great ideas. "Along with this, we test for the viability and scalability of business models by going deeper than available financial statements and understanding projected cash flows," he mentioned. Ms Padmaja lays emphasis on factors like fast growing market. "Well differentiated proposition, a promoter team which understands the challenges in the space and has a focus on execution are critical," she listed. "The three most important factors are team, technology and market opportunity," said Mr Rajeev. He believes that a world-class team, with novel and differentiated technology pursuing a large market makes for a winning combination. "Financial investors are motivated by the prospect of capital appreciation. Healthcare and Life Sciences are promising and such prospects are high. So investors are keener than ever to look at this sector," he said. A 2010 study by the Confederation of Indian Industry (CII) found that India needs $50 billion annually for the next 20 years in order to meet World Health Organization (WHO) standards. "A further injection of $82 billion is required to close the current healthcare infrastructure deficit. The sheer demand for capital along with capable entrepreneurs and new business models are key drivers," explained Mr Sanjib. Another aspect driving investments in this space is the outlook of downstream investors. With foreign private equity players looking closely in this space in India, investors are also considering areas that would look attractive to follow on investments and exits from these downstream investors. "Weightage given to an entrepreneurial team that has delivered success in the past can be higher than others. The other interesting aspect is that innovative technology per se does not appear to drive the investment decision, but needs to be coupled with a well thought-through business model at the time of investment," Mr Ashwin opined. Ms Padmaja noted an interesting trend where she points that teams with medical background are going entrepreneurial. "The entrepreneurship bug has gone viral in India! Thus teams with complimentary skillsets, high quality domain expertise, passion and focus on execution are starting out," she revealed. Investment dilemmas Regulatory uncertainty is viewed as a key challenge by many investors. "The government needs to address this immediately," urged Mr Rajeev. Mr Ashwin, on a similar line noted, "The biggest challenge today in the Life Science sector is the uncertain regulatory atmosphere related to clinical trials, and the larger problem of global acceptance of results from trials conducted in India." Initiatives like Stanford Biodesign is helping breed medical entrepreneurs. However, innovators of healthcare products are not very common in India. "Building products need higher amounts of investment as well as longer gestation time. Unlike most of the developed economies which breed innovators in building products, India does not yet have an enabling ecosystem such as grants, high-quality and well equipped research labs, and enabling IP rules among others. All of these become detrimental and make the innovator's journey arduous," said Ms Padmaja. What's trending? Mr Vishal points that in terms of investments in the Life Sciences, the momentum has been sluggish in the last couple of years. "One challenge is that the IPO market is not very vibrant. The valuation expectations of promoters are very high, and that is a deterrent. Thus, the overall ecosystem for this year in terms of investments was not very good," he remarked. However, there has been an increasing interest over the last 2-3 years in the diagnostics, drug discovery and equipments space. "The increasing number of entrepreneurs and new business models have attracted VC investors in this area. The next few years are interesting in terms of watching the investment patterns and expectations from VCs along with the performance of different business models," predicted Mr Sanjib. Experts opine that providers of healthcare at optimum cost is a big market opportunity and a growing one. "This is the opportunity which even overseas entrepreneurs are tapping. Life Sciences companies in India have attracted investments but these are largely later stage companies. While hospital chains, day care centres, personal care products have attracted most of the investment, drug trials is almost at the bottom of the heap," revealed Ms Padmaja. Mr Ashwin feels that given the huge gap in the availability of basic health infrastructure in the country there is a lot of focus on single specialty chains, diagnostics and hospitals. "Therefore, areas like devices, information systems for the healthcare space, and pharma and biotech companies are currently lower on the radar of investment firms," he ended. Happening investment areas in Healthcare and Life Sciences ï‚§ Appsï‚§ Day care centresï‚§ Diagnosticsï‚§ Disease management ï‚§ Drug discoveryï‚§ Generics ï‚§ Hospital chainsï‚§ Medical devicesï‚§ Mobile and digital healthï‚§ Pediatric careï‚§ Personal care productsï‚§ Personalized treatmentsï‚§ Telemedicine ï‚§ Virtual monitoringï‚§ Wearablesï‚§ Wellness Top 5 cities attracting Healthcare and Life Science investments ï‚§ Bangaloreï‚§ Chennaiï‚§ Delhiï‚§ Hyderabadï‚§ Mumbai Other hot destinations ï‚§ Ahmedabadï‚§ Chandigarhï‚§ Coimbatoreï‚§ Himachal Pradeshï‚§ Kolkataï‚§ Orissaï‚§ Pune Notable investment trends ï‚§ In the last five years (FY11-15YTD) cumulative PE investments have doubled close to $5.5 billion in comparison to the investments between FY2005-2010YTD. ï‚§ In volume terms, however, the number of transactions per annum have remained more or less the same over the past ten years (around 50-60 deals per year).ï‚§ The sector transactions in the last few years are now dominated by more mature stage deals (over $25 million transaction value) rather than early and growth stage transactions. This reflects the growing maturity of the sector and its ability to absorb further expansion capital to meet the continuing demand.ï‚§ Investments in healthcare delivery emerged more dominant over the years compared to investments in lifesciences. ï‚§ Healthcare delivery presently accounts nearly 70 percent of total investments transacted. Factors driving VC investments ï‚§ In pharmaceuticals, India's global competitiveness in manufacturing, regulatory and scientific strength makes it possible for investors to look at companies that capture market share and value in global generics.ï‚§ Investors look to capitalize on long-term domestic growth opportunities in healthcare and pharmaceuticals based on the increasing affordability and healthcare awareness among urban middle-class Indians.ï‚§ An estimated addition of 150 million people to the consuming middle-class over the next decade.ï‚§ Significant inequality in healthcare access in India owing to gap in healthcare infrastructure and workforce attract investors towards business models seeking to increase penetration of healthcare meeting rising demands. Key successful ventures ï‚§ Amanta Healthcare ï‚§ Consure Medicalï‚§ CromDxï‚§ Glocal Healthcareï‚§ Invictus Oncologyï‚§ Karmic Lifesciences ï‚§ Lokmanya Hospitalsï‚§ Mitra Biotech ï‚§ NovaLead Pharmaï‚§ Relisys Medical Devices ï‚§ Sandor Nephro Servicesï‚§ Shantani Proteome Analytics ï‚§ Vyome Biosciences ]]> <![CDATA[Finally approval to 100% FDI in medical devices ]]> https://biospectrumindia.com/news/95/5606/finally-approval-to-100-fdi-in-medical-devices-.html https://biospectrumindia.com/news/95/5606/finally-approval-to-100-fdi-in-medical-devices-.html Fri, 26 Dec 2014 17:22:00 +0530 In a review of the policy on Foreign Direct Investment (FDI) in pharmaceutical sector to carve out separate set of rules exclusively for medical devices, the union cabinet chaired by the Prime Minister, Mr Narendra Modi, on December 24 gave its approval to amend the existing policy. The policy on the pharma sector covers `medical devices` since this area is not separately covered. It is expected to boost the sector that has so far failed to attract much domestic capital. As per the extant FDI policy for pharma sector, FDI up to 100 percent is permitted subject to specified conditions. While FDI for green-field projects is under automatic route, brown-field projects are placed under government route. Since medical devices are part of the Drugs & Cosmetics Act, 1940 and fall under the Pharmaceutical sector, all the conditions of the FDI policy on the sector, including the condition relating to `non-compete clause`, apply on brownfield investment proposals of medical devices industry. As per National Industrial Classification (NIC) Code 2008, sector code of `Manufacture of pharmaceuticals, medicinal chemical, and botanical products` is 2100 while sector code of `Manufacture of medical and dental instruments and supplies` is 3250. Medical devices will fall under the category of `medical and dental instruments and supplies`. Therefore, drugs and pharmaceuticals and medical devices are two different industrial activities. The condition of `non-compete` was imposed so that the Indian manufacturers can continue manufacturing generic drugs and catering to the needs of the large number of people in the country and in other developing countries who cannot afford branded and patented drugs. This condition is not relevant to `medical devices` industry of the country where the country is substantially import dependent and the sector is adversely impacted because of the lack of adequate capital and required technology. Therefore, the Cabinet approved the following proposal to amend the relevant paragraphs of the extant FDI policy as contained in the Consolidated FDI Policy Circular 2014. In simple terms, a medical device means any instrument, apparatus, appliance, implant, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specially for human beings or animals for one or more of the specific purposes of diagnosis, prevention, monitoring, treatment or alleviation of any disease or disorder. Easing of norms for medical devices industry by creating special carve out in the extant FDI policy on pharma sector will encourage FDI inflows in this area. ]]> <![CDATA[ 100 biotech IPOs to raise $10 bn globally in 2015 predicts Burrill]]> https://biospectrumindia.com/news/95/5521/-100-biotech-ipos-to-raise-10-bn-globally-in-2015-predicts-burrill.html https://biospectrumindia.com/news/95/5521/-100-biotech-ipos-to-raise-10-bn-globally-in-2015-predicts-burrill.html Fri, 26 Dec 2014 15:13:43 +0530 Bangalore, 26 December 2014: Well known life sciences industry analyst, G Steven Burrill, Chairman of Burrill, predicts that about 100 IPOs( initial public offerings) by bioscience companies will happen in 2015 globally to raise another record $10 billion during the year. Releasing his annual predictions, Mr Burrill, said 2014 was a record year for life science companies as 126 IPOs raised at least $10.4 billion. Of this, 101 IPOs were in the US raising $ 6.8 billion and the rest in other global markets. According to Mr Burrill, the global financial markets are witnessing a major structural change and the share of global markets for fund raising by life sciences companies will reflect this. He predicts that the finances raised by non-US markets will more than double to account for about 40 per cent of the overall IPO financing in 2015. "There will be greater activity on foreign stock exchanges as strengthening economies, rising markets and companies in Europe and Asia raise money at home," Mr Burrill reasoned. Apart from record IPOs, overall too the global financings for the life sciences industry in 2014 was very good. The industry got funds totaling $81.9 billion in the first 11 months of 2014. During the same period in 2013, this figure was just $79.5 billion. Another key segment, the venture capital investment too fared very well in the life sciences sector. Global venture capital investments in the industry touched $15.3 in 2014 upto November compared to only $11.5 billion during the same time in 2013. "Venture investors are flush with new funds and are recycling capital thanks to the IPO and mergers & acquisition activities of recent years. We expect 2015 to be a banner year for venture investment, but will also see a continued migration from seed and early stage biotech that may be more than 10 years away from revenue," Mr Burrill said. Mr Burrill predicted that more capital flows will reach new types of healthcare companies that leverage digital technologies to improve efficiency in the healthcare systems. This could lead to new types of patient monitoring systems and early interventions, leverage data available to improve health and transform healthcare access and delivery models. ]]> <![CDATA[GSK receives EU authorization for Mekinist]]> https://biospectrumindia.com/news/95/5595/gsk-receives-eu-authorization-for-mekinist.html https://biospectrumindia.com/news/95/5595/gsk-receives-eu-authorization-for-mekinist.html Thu, 25 Dec 2014 10:45:00 +0530 Mekinist (trametinib) is used in treating patients with unresectable or metastatic melanoma with BRAF (a gene) V600 mutation. Trametinib has not demonstrated clinical activity in patients who have progressed on a prior BRAF inhibitor therapy. Before taking trametinib, patients must have confirmation of a BRAF V600 mutation using a validated test. Trametinib is a MEK inhibitor which blocks the activity of a protein kinase called MEK-1. This protein is present in the MAPK pathway, which regulates the normal growth and death of cells and plays a role in metastatic melanoma development. Some mutations in the BRAF gene can cause the MEK protein to stimulate cancer cell growth and survival; therefore, inhibiting MEK can potentially slow down the growth of tumors in BRAF-mutant metastatic melanoma. Dr Paolo Paoletti, president of oncology, GSK said: "We welcome today's decision of the European Commission. MEK has been pursued as a therapeutic target in cancer for more than a decade, and Mekinist is the first medicine in this class to be licensed in Europe." ]]> <![CDATA[India slashes its healthcare spending by 20 percent]]> https://biospectrumindia.com/news/95/5033/india-slashes-its-healthcare-spending-by-20-percent.html https://biospectrumindia.com/news/95/5033/india-slashes-its-healthcare-spending-by-20-percent.html Wed, 24 Dec 2014 15:43:33 +0530 Singapore: After promising statements and assurances to transform the healthcare scenario of India, the Government led by Prime minister Mr Narendra Modi in India is taking a U-turn. Due to fiscal starins, the government has ordered a 20 percent cut on healthcare spending. India already spends only 1 percent of its GDP on healthcare, compared to 8.3 percent in the United States and 3 percent in China. Around $947mn has been slashed from the Health Ministry's budget allocation of around $5bn for the financial year ending 31 March, 2015, reported Reuters. The news could jeopardize key research and drug discovery initiatives already underway in many academic institutes and research organizations of India. The Finance Ministry also announced a further 30 percent slash in funding for India's HIV/AIDS program. "We were not expecting (budget cuts) this time because of the commitments they made in the manifesto," one of the health ministry officials said, referring to Modi's Bharatiya Janata Party (BJP). "No reason was given ... but there is shortage of funds. It is not rocket science." Earlier this year Mr Modi had announced an ambitious universal healthcare program that can provide free drugs and diagnostics to all, with insurance benefits. Officials estimate that the $25 bn program might also be derailed because of financial strains. India's healthcare is mostly dominated by private players is registering 15 percent growth annually, however, public spending has remained low, resulting in a dilapidated network of government hospitals and clinics, especially in rural areas. ]]> <![CDATA[Cell phones linked to infertility]]> https://biospectrumindia.com/news/95/5596/cell-phones-linked-to-infertility.html https://biospectrumindia.com/news/95/5596/cell-phones-linked-to-infertility.html Wed, 24 Dec 2014 15:12:53 +0530 "However, every coin has a flip side. Research says that compared to the United States an average Indian is exposed to 5-10 times higher levels of electromagnetic radiation, emitted from cellular towers and mobile phones," said Dr Aviva Pinto, Infertility Consultant, Nova IVI Fertility, Bangalore. Studies conducted in this area show that effects of radiation include DNA damage and inability to self-repair, lowered immunity, decreased melatonin levels, cell damage and many more. But above all the most serious health hazard is infertility. Clinical data estimates that almost 15 percent of Indian couples suffer from some form of infertility. In men, studies link mobile phone use with decrease in production and quality of a man's sperm, while in women, research suggests that exposure to cellular radiation could be harmful to both expectant mothers and their unborn children. "Exposure to radiation in the last months of pregnancy can affect the spinal cord of the baby. In addition, some studies have shown that mobile phone radiation can cause damage to the DNA of cells. It can cause damage to chromosomes, changes to the activity of certain genes and an increase in the rate of cell division and replication," pointed Dr Aviva. Most mobile phones transmit and receive Radiofrequency (RF) radiation at frequencies between 825 and 915 megahertz (MHz). These radio waves are emitted by both mobile phone handsets and base stations. RF radiation has the ability to heat human tissue, similar to the way in which microwave oven heats food. The thermal effects produced by the electromagnetic field of the radio waves cause polar molecules in the body to generate dielectric heat and this heat can cause live tissue to die. As per a study conducted by the Ohio State University College of Medicine, women who lived within 100 meters of cell phone towers have more stress and a two-fold increased risk of infertility. For women trying to get pregnant, stress is measured by the protein (alpha-amylase) levels in their saliva. According to the study, women with highest levels of this protein in their saliva had a 29 percent lower probability of pregnancy compared to those with the lowest levels. Cordless phones emit the same type of radiation as mobile phones, however some experts believe they are even more dangerous than mobile phones. "This belief is due to the fact that the base stations of cordless phones emit the same type of radiation as a mobile phone station tower, and depending on the model sometimes more than twice the amount of radiation as mobile phone tower," commented Dr Aviva. Radiation emissions from the base station of a cordless phone can be as high as six volts per metre - which is twice as strong as those found within 100 metres of mobile phone station towers. When standing two meters away from the base of a cordless phone, you would still receive radiation as high as 2.5 volts per metre-that's 50 times higher than what scientists regard as a safe level. The best way to avoid exposure to cordless phone radiation is to not have one in your home or office. Wireless technology such as wireless internet, computer networks and hot-spots as well as wireless mice, keyboards and speakers, also operate by using radio frequency non-ionising radiation similar to that used by mobile. Exposure to these low-level electromagnetic waves radiated from wireless technology devices can in the same way have grave impact on to health and fertility, causing cellular damage and possibly cancer. Thermal impact of electronic devices is as dangerous. In a study published in the journal Human Reproduction, research done on Finnish men in their 30's who had normal sperm count were made to spend 15 minutes in a sauna twice a week for three months. It was found that, saunas, steam bath, heated waterbed and Jacuzzi damage sperms and lower the count of even healthy men. Similarly, radiations emitted while using laptop placed on lap for long periods of time may also affect sperm quality and quantity. This is due to the heat generated by the laptop. Testicles are more vulnerable to heat than ovaries, so women are unlikely to be affected in the same way. Since eggs are produced in the ovaries, which are inside a woman's body, heat from a laptop or other external source is not likely to be so intense that it raises the core body temperature enough to damage the ovaries and hurt egg production. Dr Aviva advised, "To overcome fertility problems, it's important to make conscious choices and use technology judiciously. Simple lifestyle changes like avoid keeping phones in pocket, distance cell phone from belly when pregnant and use of texting more than talking can go a long way in ensuring a healthy life." ]]> <![CDATA[DST and DBT's open access policy approved ]]> https://biospectrumindia.com/news/95/5585/dst-and-dbts-open-access-policy-approved-.html https://biospectrumindia.com/news/95/5585/dst-and-dbts-open-access-policy-approved-.html Wed, 24 Dec 2014 15:05:13 +0530 After a lot of consultations and recommendations from experts and public, the final draft of the open access policy (OAP) has been approved. The final OAP document is now available on the DBT and DST websites. The policy assumes significance as the researchers and others will now have access to the DBT and DST funded projects. While these high profile departments of the ministry of science and technology expect the scientists to publish their research work in the journals of choice, these also feel that the researchers are best judges of that. The policy document mentions maximizing of the distribution of these publications by providing the free access by depositing them in an institutional repository is the most effective way of ensuring that the research funded by these agencies, gets utilized for the benefit of society. The published work can be either deposited in the local institutional repository or the central repository (in case there is none). As per the December 13 document, papers resulting from funds received from the fiscal year 2012-13 onwards are required to be deposited. Authors are recommended to also deposit manuscripts of their earlier publications even if they are unrelated to curent projects funded by DBT or DST. Instiutions are encouraged to use these repositories as central repositories for al the publications arising from research in their organizations irrespective of source of funding. Every year DBT and DST institutes have been directed to celebrate â€œOpen Acess Dayâ€? during the International Open Acess Week by organizing sensitizing lectures, programmes, workshops and taking new open aces initiatives. ]]> <![CDATA[Govt to conduct quality check of exported drugs ]]> https://biospectrumindia.com/news/95/5509/govt-to-conduct-quality-check-of-exported-drugs-.html https://biospectrumindia.com/news/95/5509/govt-to-conduct-quality-check-of-exported-drugs-.html Wed, 24 Dec 2014 10:18:24 +0530 As per the union health minister, Mr J P Nadda, the isolated reports of export of allegedly substandard drugs by Indian Pharmaceutical companies to other countries including African countries have been received. "Drugs for export are manufactured under license granted by the State Licensing Authorities. The reports on quality of exported drugs, when received by the Central Drugs Standard Control Organization (CDSCO) are investigated jointly by CDSCO and the concerned State Drugs Controllers. Based on the findings of the investigations, the State Licensing Authorities take suitable action under the provisions of the Drugs and Cosmetics Act, 1940 and Rules made there under," Mr Nadda stated this in a written reply in the Parliament on December 23. ]]> <![CDATA[PAU renews MoU with Syngenta ]]> https://biospectrumindia.com/news/95/5508/pau-renews-mou-with-syngenta-.html https://biospectrumindia.com/news/95/5508/pau-renews-mou-with-syngenta-.html Wed, 24 Dec 2014 10:16:54 +0530 Punjab Agricultural University (PAU) has extended its agreement with Syngenta India, one of country's leading agribusiness companies, for three years. Under its public-private partnership program, PAU had first signed a MoU with Syngenta India in October 2008 and again in October 2011 to jointly undertake projects aimed towards sustainable development in the agricultural sector. Now the MOU is further extended for three years upto December, 2017. PAU and Syngenta have a singular aim, that of enhancing productivity and quality of farm produce in Punjab, by adopting latest technology in key crops like Corn, Rice, Wheat and Potato. Under the MoU Syngenta and PAU will initiate projects to develop and demonstrate crop solutions and educate growers on enhancing productivity, quality, and shelf life of their farm produce. The two organizations will also jointly undertake other related research and development activities. â€œSyngenta and PAU are working together to bring to Punjab growers an array of crop solutions for cotton, wheat, rice, potato, vegetables and corn which will help Punjab farmers diversify. These solutions will support farmers in all 22 districts of the state increase yield and productivity. Our partnership with PAU over the past few years has been very fruitful and insightful for us. We have gained a lot through our collaboration with the university,â€? said Bipin Solanki, MD & Territory Head, Syngenta South Asia. Dr Balwinder Singh, Director of Research, PAU, suggested tie-up in the areas of direct seeded rice technology, integrated pest management and spraying application techniques. Besides, he also wished to have cooperation in promoting cultivation of maize and sugarcane for diversification. ]]> <![CDATA[BIRAC's portal receives CSI Nihilent e-Governance Award 2013-14]]> https://biospectrumindia.com/news/95/5448/biracs-portal-receives-csi-nihilent-e-governance-award-2013-14.html https://biospectrumindia.com/news/95/5448/biracs-portal-receives-csi-nihilent-e-governance-award-2013-14.html Tue, 23 Dec 2014 14:53:47 +0530 The BIRAC's 3i - "Investment for Industry Innovation Research" - Portal has been developed for sustainable, accountable, transparent governance and management of the Investment Schemes of national importance run and managed by BIRAC. In anticipation of the impetus that NeGP was going to give to the domain of e-Governance in the country, the CSI-Nihilent e-Governance awards were instituted way back at the beginning of the current millennium with three major objectives.including to be an independent focal point for the assessment of e-Governance initiatives in the country; to take the lead in recording appreciation of the vision and the effort of various levels of government officials in bringing e-governance initiatives to fruition against difficult odds. Over the years, the awards forum has received over a thousand nominations under various categories and a large number of them have been reported as case studies and have had their experiences globally shared through their inclusion in the Annual Compendium released by CSI SIG e-GOV. ]]> <![CDATA[Dengue vaccine market to witness rapid growth from 2015]]> https://biospectrumindia.com/news/95/5443/dengue-vaccine-market-to-witness-rapid-growth-from-2015.html https://biospectrumindia.com/news/95/5443/dengue-vaccine-market-to-witness-rapid-growth-from-2015.html Tue, 23 Dec 2014 14:45:49 +0530 Among the five major pharmaceutical markets (5MM: Brazil, India, Mexico, Singapore and Thailand), Brazil and Mexico are projected to be the leading contributors to the dengue vaccine marketplace, as it expands rapidly from an estimated $70 million in 2015 to $400 million by 2020, at a Compound Annual Growth Rate (CAGR) of 42 percent, according to research and consulting firm GlobalData. The company's latest report states that Brazil and Mexico will achieve a combined market share of over 98 percent across the 5MM in 2015, with respective sales of $45 million, equaling a 64 percent market share, and $24million (34 percent). However, these shares will change dramatically by 2020, as Mexico will surge ahead to generate $217 million, a 54 percent market share, while Brazil's more modest growth will take it to $97 million (24 percent). Growth in Brazil will be stymied by the arrival of a domestically-produced, live-attenuated dengue vaccine, TV-003, which GlobalData expects to seize substantial market share from big pharma-manufactured vaccines due to its lower price per dose. Dr Christopher J Pace, GlobalData's Analyst covering infectious diseases, says, "The rapid uptake of dengue vaccines will be driven primarily by the inclusion of live-attenuated vaccines in national immunization programs. "Past failures of vector control initiatives to curtail the spread of the Aedes aegypti mosquito have left a glaring void in the dengue prevention and control landscape, which will hasten the uptake of vaccines. We expect manufacturers to target the pediatric population for vaccination, as this will likely improve coverage rates and provide a more sustained revenue source for these vaccine manufacturers." GlobalData anticipates that the superior clinical and commercial positioning of live-attenuated dengue vaccines, led by Sanofi's CYD-TDV and Takeda's DENVax, will facilitate their market dominance, with sales of these products across the 5MM projected to reach $166 million, a 42 percent market share, and $148 million (37 percent), respectively, by 2020. Dr Pace continues: "Although CYD-TDV is anticipated to be the first dengue vaccine to reach the market, GlobalData expects second-to-market DENVax to seize a significant share of the marketplace due to its more convenient dosing schedule." ]]> <![CDATA[Encephalitis cases on rise, Govt ensures quick response]]> https://biospectrumindia.com/news/95/5806/encephalitis-cases-on-rise-govt-ensures-quick-response.html https://biospectrumindia.com/news/95/5806/encephalitis-cases-on-rise-govt-ensures-quick-response.html Tue, 23 Dec 2014 14:40:21 +0530 As per the union health minister, Mr JP Nadda recently in Muzaffarpur and Malda, cases reported for Encephalitis were neither due to Japanese Encephalitis nor due to entero-viruses. Normally, Encephalitis is affecting children below 15 years of age. However, in the last few years, epidemiological data has revealed that many adults are also being affected and cases of morbidity and mortality, particular for JE, have been observed in adults in Assam and recently in the districts of North Bengal. The total numbers of Encephalitis cases reported were 5,167 in 2010, 8,249 in 2011, 8,344 in 2012, 7,825 in 2013 and 9,912 cases this year up to 17th December. For mortality the numbers were 679 in 2010, 1,169 in 2011, 1,256 in 2012, 1,273 in 2013 and 1,495 up to 17th December, this year. In terms of distribution of cases this year, we find that the maximum reported numbers of 3,291 cases were from Uttar Pradesh, followed by 2,317 cases in West Bengal, 2,194 cases in Assam and 866 cases in Bihar. The main districts affected in Uttar Pradesh are Khushinagar, Deoria, Maharajganj Gorakhpur, and Sidharthnagar; in Bihar the district Muzaffarpur; in West Bengal, the districts Jalpaiguri, Bankura, Darjeeling, Coochbehar, Burdwan and Bankura and in Assam, the districts Sonitpur, Golaghat, Dhimaji, Shivsagar, Dibrugarh, Kamrup (Metro) and Tinsukia "The government of India launched a National Program for Prevention and Control of JE/AES in the end of 2012-13. This Program envisages a multipronged strategy in 60 high priority districts in five high endemic States of Assam, Bihar, Uttar Pradesh, Tamil Nadu and West Bengal. The districts covered include 20 in Uttar Pradesh, 15 in Bihar, 10 in Assam, 10 in West Bengal and 5 in Tamil Nadu. The stakeholder Ministries include Ministry of Drinking Water and Sanitation with the task to provide safe drinking water and sanitation facility; Ministry of Social Justice & Empowerment with the task to provide rehabilitative services to disabled children; Ministry of Women and Child Development to provide nutrition to children in the affected districts; Ministry of Housing and Poverty Alleviation to provide drinking water facility in urban slums and Ministry of Human Resource Development (Education Department) to develop special curriculum for mentally and physically disabled children. The Ministry of Health and Family Welfare is the nodal Ministry with the task to vaccinate the children in the endemic districts, to improve the case management by establishing Pediatric ICUs at district hospitals, to establish Physical Medicine and Rehabilitation Departments and to strengthen public health measures including information-education-communication/behavior-change-communication for prevention and control of JE/AES," mentioned Mr JP Nadda. Under the National Program, for JE vaccination, out of 60 high priority districts, vaccination has been completed in 59 districts, the remaining one District (Kanpur Dehat) will also be covered during this financial year. Funds have been released for setting up of Pediatric ICUs in 27 districts. We are following up with the State Governments for setting up and complete operationalization of these Pediatric ICUs on priority. This requires civil work, procurement of equipment and recruitment of manpower. While the Physical and Medical Rehabilitation Department at BRD Medical College, Gorakhpur is already functional, the Units at KG Medical College, Lucknow; BHU, Varanasi; Bankura Medical College; North Bengal Medical College; Gaya Medical College and Patna Medical College require upgradation. Units are required to be set-up at Assam Medical College, Dibrugarh and at Guwahati Medical College in Assam. Out of total 10 proposed Physical Medicine and Rehabilitation Units, Rs 25 crores has already been released for 5 Physical Medicine and Rehabilitation units in 2013-14 and for another 4 units release of Rs 20 crores is under process. Vector control and surveillance activities are being supported under National Vector Borne Disease Control Program. Surveillance is also being undertaken through the Integrated Disease Surveillance Project under the National Centre for Disease Control (NCDC). For detection of non JE pathogens, Indian Council of Medical Research has established a field unit of National Institute of Virology, at BRD Medical College, Gorakhpur. In addition, ICMR is conducting research-cum-intervention projects. NIV, Pune is supplying IgM ELISA kits to sentinel laboratories for the detection of JE cases. These kits are funded by the Directorate of National Vector Borne Disease Control Program, government of India. This was started in 2006 and was scaled up in a phased manner over years. The strategy for JE vaccination is to conduct a one-time campaign (which targets all children from 1-15 years of age), after which JE vaccination is included as a part of routine immunization in that area. Initially, only one dose of JE vaccine was provided at the age of 16 to 24 months (with DPT/OPV booster). From April, 2013 onwards two doses for JE are scheduled under routine immunization, the first at 9 to12 months and second at 16 to 24 months of age. Out of 179 JE endemic districts in the country, 152 districts have been covered by vaccination from 2006 to 2014. Further, a catch up round to cover children missed out during the campaign and routine immunization rounds has been carried out on 22-23 June, 2014 for ten districts of Uttar Pradesh and eight districts of Bihar. Due to recent cases of JE in adults, this issue was discussed in the National Technical Advisory Group on Immunization. It was decided that we can take up vaccination for adults too in districts where such adult cases are being reported. The Assam Government has covered adults with JE vaccination in nine districts. This has been beneficial. It is crucial that the coverage of immunization remains high. Our reports show that routine immunization undertaken by the States may not have high coverage in all the target districts. States must, therefore, focus on this important aspect also. The minister revealed that the funds released under National Vector Borne Diseases Control Programme during 2014-15 to Assam were Rs 9.16 crores, Bihar Rs 28.57 crores, Tamil Nadu Rs 15.61 crores, Uttar Pradesh Rs 23.76 crores and West Bengal Rs 18 crores. These funds are to be used for prevention and control of Vector Borne Disease including implementation of the JE/AES activities. In addition, Rs 5.35 crores has been released under NHM flexi pool to support the contractual human resources at JE/AES wards at BRD Medical College, Gorakhpur. Similarly, in 2011-12 and 2012-13 too an amount of Rs 3.05 crores was released under NHM to improve the manpower situation at BRD Medical College, Gorakhpur. ]]> <![CDATA[APAC's Glioblastoma Multiforme treatment market to double by 2020]]> https://biospectrumindia.com/news/95/7758/apacs-glioblastoma-multiforme-treatment-market-to-double-by-2020.html https://biospectrumindia.com/news/95/7758/apacs-glioblastoma-multiforme-treatment-market-to-double-by-2020.html Tue, 23 Dec 2014 14:35:55 +0530 The company's latest report states that this impressive growth will result from the anticipated approval, and market entries of Rindopepimut, Cotara, and Avastin in some APAC countries during the forecast period. Ms Vijaya Vulapalli, senior analyst, GBI Research, said, "The APAC region boasts a strong GBM pipeline, which also includes carmustine implants, currently being developed in China. Novel therapies Rindopepimut and Cotara in particular could have a significant bearing on APAC's GBM treatment landscape. "Phase II clinical studies of Rindopepimut demonstrated a relatively high median Overall Survival (OS) rate among patients. Meanwhile, Cotara's Phase II studies showed similar OS to Avastin, with slightly more progression-free survival improvement in recurrent GBM. As a single-infusion therapy, Cotara is likely to become an effective second-line treatment option for patients." However, GBI Research states that even if these therapies prove successful in late-stage clinical trials, they will experience low uptake in their respective markets due to their high prices and lack of patient access to medicines, mainly in China and India. Furthermore, APAC's GBM treatment space is still expected to require new drugs with better efficacy and improved prognosis. Ms Vulapalli continued, "One of the key reasons for the lack of efficacy exhibited by most therapies is their inability to penetrate the blood-brain barrier, and an urgent unmet need will remain over the forecast period for drugs that can achieve this." "Efficacy also remains low because therapeutic resistance develops due to the disease heterogeneity, which is believed to be increased by genetic variations arising from mutations. A combined therapy that acts on multiple tumor signaling pathways, rather than a single molecular target, may therefore be more effective and result in a better prognosis," the analyst concluded. ]]> <![CDATA[Mortality due to diseases on decline in India says Lancet study]]> https://biospectrumindia.com/news/95/5154/mortality-due-to-diseases-on-decline-in-india-says-lancet-study.html https://biospectrumindia.com/news/95/5154/mortality-due-to-diseases-on-decline-in-india-says-lancet-study.html Mon, 22 Dec 2014 18:18:30 +0530 People are living much longer worldwide than they were two decades ago, as death rates from infectious diseases and cardiovascular disease have fallen, according to a new, first-ever journal publication of country-specific cause-of-death data for 188 countries. Published in The Lancet on December 18, the study, "Global, regional, and national age-sex-specific all-cause and cause-specific mortality for 240 causes of death, 1990-2013: a systematic analysis for the Global Burden of Disease Study 2013," was conducted by an international consortium of more than 700 researchers led by the Institute for Health Metrics and Evaluation (IHME) at the University of Washington. As per study, given the size of India's population in particular, and projections that it may soon become the world's most populous country, mortality trends there have global implications. In 2013, India accounted for 19 percent, or 10.2 million, of the world's deaths. The country has made great strides in reducing both child and adult mortality since 1990. The average yearly rates of decline in mortality have been 3.7% per year for children and 1.3% per year for adults. Between 1990 and 2013, life expectancy at birth increased from 57.3 years to 64.2 years for males and from 58.2 years to 68.5 years for females. "It's very encouraging that adults and children in India are living longer and healthier lives," said Dr Jeemon Panniyammakal of the Public Health Foundation of India and a co-author of the study. "But India's growing influence on global health means we must do more to address the diseases that kill people prematurely." Compared to previous Global Burden of Disease (GBD) studies, researchers from more than 100 nations incorporated more country-level data as well as additional data on specific conditions. They also examined whether leading causes of death in lower-income countries are beginning to mirror those in higher-income countries. What they found is that even with big improvements in longevity in low-income countries, the types of health challenges faced by countries such as Bolivia, Nepal, and Niger are far different from those faced by countries such as the Japan, Spain, and the United States. The health challenges of many middle-income countries such as China or Brazil are also closer to those in the US. Causes of death vary widely by country, but, at the global level, drug use disorders and chronic kidney disease account for some of the largest percent increases in premature deaths since 1990. Death rates from some cancers, including pancreatic cancer and kidney cancer, also increased. At the same time, countries have made great strides in reducing mortality from diseases such as measles and diarrhea, with 83 percent and 51 percent reductions, respectively, from 1990 to 2013. Globally, three conditions - ischemic heart disease, stroke, and chronic obstructive pulmonary disease (COPD) - claimed the most lives in 2013, accounting for nearly 32% of all deaths. The average age of death increased from 46.7 in 1990 to 59.3 in 2013, as a result of declining fertility and a demographic shift in the world's population to older ages. Partly because of global population growth, the number of deaths in both sexes for all ages combined increased from 47.5 million to 54.9 million. The number of people dying from certain conditions, such as heart disease, has increased as population has increased, but decreases in age-specific mortality rates for these conditions is a sign of progress. Death rates from most cancers, including breast cancer, cervical cancer, and colon cancer, have decreased, but the reverse is true for pancreatic cancer, kidney cancer, and non-Hodgkin lymphoma. "People today are less likely than their parents to die from certain conditions, but there are more people of older ages throughout the world," said IHME Director Dr. Christopher Murray. "This is an encouraging trend as people are living longer. We just need to make sure we are making the right health policy decisions today to prepare for the health challenges and associated costs that are coming." Global life expectancy for both sexes increased from 65.3 years in 1990 to 71.5 years in 2013, and women made slightly greater gains than men. Female life expectancy at birth increased by 6.6 years and male life expectancy by 5.8 years. If trends seen over the past 23 years hold, by 2030 global female life expectancy will be 85.3 years and male life expectancy will be 78.1 years. Disparities remain across age groups and countries. In all age groups except 80 and older, mortality has decreased more for women than men. Men aged 30-39 and over 80 showed some of the smallest declines in mortality. The gender gap in death rates for adults between the ages of 20 and 44 is widening, and HIV/AIDS, interpersonal violence, road injury, and maternal mortality are some of the key conditions responsible. For children under 5, diarrheal diseases, lower respiratory tract infections, neonatal disorders, and malaria are still among the leading causes of death. ]]> <![CDATA[A new way to tackle type 2 diabetes]]> https://biospectrumindia.com/news/95/7853/a-new-way-to-tackle-type-2-diabetes.html https://biospectrumindia.com/news/95/7853/a-new-way-to-tackle-type-2-diabetes.html Mon, 22 Dec 2014 16:07:15 +0530 Current therapies for type 2 diabetes are not able to stop the progressive deterioration of pancreatic beta-cell function that drives the natural history of the condition. A new meta-analysis study conducted on patients in US and Canada, by a team of scientists led by Dr Ravi Retnakaran, endocrinologist & clinician-scientist, Mount Sinai Hospital, Toronto, Canada, focuses on the early use of insulin therapy to improve beta-cell function and stop the deterioration of these cells, promising a new ray of hope to tackle the disease more efficiently. "The concept is that, early in the course of type 2 diabetes, the dysfunction of the beta-cells is largely reversible. Thus, we are interested in short-term intensive insulin therapy early in the course of type 2 diabetes, so that we can put this disease into 'remission' so to speak," opined Dr Ravi. The therapy has been studied in various settings around the world. The study has been published in Lancet Diabetes journal in 2013, showing that the therapy can consistently improve beta-cell function and the action of insulin in the body, when applied in patients with recently-diagnosed type 2 diabetes. "Furthermore, it could induce remission of diabetes wherein patients could maintain glucose control off anti-diabetic medications for some time thereafter," Dr Ravi said. Speaking on the relevancy of the therapy on Asian and Indian patients, Dr Ravi commented, "This therapy has been most frequently studied in Asian patients, though our experience has been that it is similarly effective across ethnic groups. As such, we would anticipate that it would be applicable to Indian patients as well." Dr Ravi feels that because of the wide availability of insulin, he anticipates that this therapy will be applicable to emerging countries. "That said, the appropriate implementation in a given setting or country will be dependent on the availability of local resources such as diabetes nurse support and access to medication," he pointed. He also expressed interest in collaborating with Indian biotech companies if appropriate opportunities arose. The research was conducted by a group of research experts consisting of clinician scientists, diabetes nurses, dietitians, post-doctoral fellows and research assistants. When asked about the affordability of the therapy, Dr Ravi said, "The affordability and accessibility will be dependent on the optimal medication preparations for applying this therapy. In this regard, we and others are testing different strategies in order to first identify the optimal preparations." ]]> <![CDATA[Scientist-farmer interaction must for agricultural growth: Mr Balyan]]> https://biospectrumindia.com/news/95/6477/scientist-farmer-interaction-must-for-agricultural-growth-mr-balyan.html https://biospectrumindia.com/news/95/6477/scientist-farmer-interaction-must-for-agricultural-growth-mr-balyan.html Mon, 22 Dec 2014 14:37:33 +0530 Dr Sanjeev Kumar Balyan, union minister of state for agriculture who was the chief guest at the Kisan Goshthi-cum-Exhibition organised in Barwala village of Muzzafarnagar on 14 December 2014, emphasized that such sensitization programs and live demonstration of technologies at the farmers' door will enthuse confidence to adopt modern technologies. Dr Balyan further stated that action research programs can help tremendously in diffusion of technologies. The theme of the event was "Efficient water management for higher sugarcane productivity".More than 700 farmers participated in the program. Dr Alok K Sikka, DDG (NRM), ICAR said that Muzaffarnagar district is known as Sugar Bowl of India as is under severe stress due to over-exploitation of ground water. In over-exploited blocks, the ground water is declining at a alarming rate and urged that integrated effort of managing demand and augmenting supply can reverse the process of declining water resources. Dr HS Gaur, VC (SBPAU&T) stressed upon the soil health management and informed that soil health card is being prepared by KVK, Muzaffarnagar and fertilizer application based on soil test will help to balance the fertilizer application. ]]> <![CDATA[Affordable medicines our top priority: Minister]]> https://biospectrumindia.com/news/95/5045/affordable-medicines-our-top-priority-minister.html https://biospectrumindia.com/news/95/5045/affordable-medicines-our-top-priority-minister.html Mon, 22 Dec 2014 13:25:49 +0530 Delivering the keynote address at the 11th India Health Summit organized by CII on the theme "Health for All: Call for Action" on December 18, 2014, Mr Shripad Yesso Naik highlighted the initiatives of his ministry in providing healthcare in the country, including achievements under the National Health Mission, the Universal Immunisation Programme for the children, providing healthcare services for mother and child, and addressing challenges posed by non-communicable diseases such as diabetes, cancer, hypertension etc. Naik stated that significant achievements have been achievements in addressing TB and Malaria, while there are concerted efforts being made to eliminate Filaria and Kala Azar. The minister said that efforts are being made to reduce the Out of Pocket expenses on healthcare by the common man in the country, which are substantial. The National Health Assurance Mission is a noteworthy step in this direction, he mentioned. Naik stated that technology can be effectively used to bridge the geographical distance. Telemedicine is being used to address the constraints and challenges of the terrain in the country, he informed. The Health Summit is a timely opportunity to talk on the topic of "Health for All", the minister said. He added that all stakeholders in the healthcare sector need to work towards this aim. Mr Lov Verma, secretary, ministry of health and family Welfare, in his address highlighted the primary pillars of the National Health Awsurance Mission which include preventive and promotive healthcare; provisioning of free essential drugs, diagnostics and healthcare services; and strengthening the tertiary tier. The key concerns in healthcare in the country are equity, affordability, accessibility and quality, he noted. He stated that while we are ahead on the global parameters in MMR, we are well on way to achieve the MDG milestone for IMR and below-five mortality rates. The summit will have panel discussions and presentations on topics such as economics of healthcare deliver; challenges of sustainability in quality healthcare delivery; real solutions in virtual healthcare; preparing workforce for meeting the challenges in healthcare; Make in India: unlocking the potential in healthcare sector; and Swachh and Swastha Bharat: laying the foundation of a healthier India. Present during the inaugural session of the two-day 11th India Health Summit were Dr Naresh Trehan, Chairman, CII National Committee on Healthcare; Shri Harpal Singh, Chairman Emeritus Fortis Healthcare Ltd., and Shri Rahul Khosla, Co-Chairman, CII National Committee on Healthcare. ]]> <![CDATA[Dr Anup Karwa receives India US S&T Innovation Award]]> https://biospectrumindia.com/news/95/5037/dr-anup-karwa-receives-india-us-st-innovation-award.html https://biospectrumindia.com/news/95/5037/dr-anup-karwa-receives-india-us-st-innovation-award.html Mon, 22 Dec 2014 12:20:44 +0530 Indo-US Joint Commission Meeting (JCM) on Science and Technology held on 17th November, 2014 at New Delhi co-chaired by Mr Y S Chowdary, minister of state for science and technology, government of India and Dr John Holdren, director, White House Office of Science and Technology Policy, USA conferred a certificate of appreciation for scientific innovation to Dr Anup Karwa of SFPL Crop Life Sciences (P), Jalna for the project to develop a technology that confers stress tolerance in crops. The event was attended by several eminent dignitaries of DST, DBT, CSIR, Technology Development Board, USAID, Indo-US S&T Forum and other ministries. Prof. K VijayRaghavan, secretary of Department of Biotechnology (DBT), government of India was also present. The Indo-US JCM awarded most innovative bilateral projects of India and USA that can potentially revolutionize the social entrepreneurship and offer innovation driven solution to tackle problems of this century, from which SFPL's technology mitigates impact of climate and enables the crops to flourish under different stresses. The product enables a broad-spectrum of agricultural crops to flourish under areas of drought, extreme temperatures and saline soils. The first field trials on Cotton, Maize, Okra and Onion yielded 18-22 percent extra over the control plots under stressed conditions like limited water. This product strategy is set to enhance below and above ground crop biomass under stress conditions by improving water and nutrient use efficiency of plants thereby giving additional earnings to the farmers. "We are pleased to receive this prestigious recognition which motivates us to develop indigenous biological technology solutions that can address agriculture productivity especially due to erratic climate scenario faced by tropical countries. SFPL envisage to commercialize novel biological products tailored for Indian farming community", said Mr Sharad Lahoti- Director of SFPL. ]]> <![CDATA[Stem cell therapies gaining momentum amidst challenges]]> https://biospectrumindia.com/news/95/4801/stem-cell-therapies-gaining-momentum-amidst-challenges.html https://biospectrumindia.com/news/95/4801/stem-cell-therapies-gaining-momentum-amidst-challenges.html Fri, 19 Dec 2014 17:37:24 +0530 The company's latest report states that complicated manufacturing processes, untested regulatory pathways and a demanding economic landscape are the largest barriers to progress in the stem cell sector, with a number of companies finding the business unviable. Ms Aparna Krishnan, GlobalData's analyst covering Healthcare Industry Dynamics, said, "The financial challenges to the industry have been profound, intensified by the technology's high failure rates." She explains, "Most firms operating in stem cells are undercapitalized and rely heavily on research grants, leveraged finance, and capital raised from public offerings or venture capital investment to fund their research efforts and expansion. "As a result, the recession impacted the flow of investments into the sector at a crucial time in its evolution. Many startups and small companies that form a significant part of the industry lacked financial discipline and often over-leveraged themselves." Despite this, GlobalData says that there has been increasing investment capital flowing in from venture capital firms, reaching a maximum of $200 million in 2012, and there are continued signs of investment strength through 2013 and 2014. The analyst continued, "With the economy stabilizing, attention from major drug firms such as Pfizer and Novartis is growing, as they seek to diversify their businesses in growth segments through licensing deals and acquisitions. "Also, some stem cell companies, including Bluebird Bio and Capricor, have concluded initial public offerings, raising enough capital to continue research and development efforts in the process." Ms Krishnan added that the opportunity provided by stem cells in regenerative medicine, among other areas, is clear from the current crop of stem cell companies and their research pipelines. "The scientific advancement of adult stem cells and the new technology's demonstrable clinical benefits have led to increasing patient acceptance. As such, GlobalData believes that stem cells are likely to become an integral part of the pharmaceutical industry's R&D process," the analyst concluded. ]]> <![CDATA[Pythagoras theorem to aid studying patients' health ]]> https://biospectrumindia.com/news/95/5331/pythagoras-theorem-to-aid-studying-patients-health-.html https://biospectrumindia.com/news/95/5331/pythagoras-theorem-to-aid-studying-patients-health-.html Fri, 19 Dec 2014 16:47:00 +0530 A medical researcher at the University of Warwick, UK, has found the 2,500 year-old Pythagoras theorem could be the most effective way to identify the point at which a patient's health begins to improve. In a paper published in PLOS ONE, Dr Rob Froud from Warwick Medical School at the University of Warwick worked with his colleague Dr Gary Abel from the University of Cambridge. They made the discovery after looking at data from ROC (Receiver Operating Characteristic) curves. These curves were initially developed during World War II for the analysis of signals to help operators decide whether a blip on the screen was an enemy target or allied forces ships or aircrafts. In the 1980s, the curves were adopted by epidemiologists to help them decide at what point an individual has recovered from an illness. Dr Froud said: "It all comes down to choosing a point on a curve to determine when recovery has occurred. For many chronic conditions, epidemiologists agree that the correct point to choose is that which is closest to the top-left corner of the plot containing the curve. As we stopped to think about it, it struck us as obvious that the way to choose this point was by using Pythagoras theorem." Pythagoras theorem states that in a right-angled triangle, the sum of the squares of the two right-angled sides is equal to the square of the hypotenuse. This means that one can determine the length of the hypotenuse given the length of the other two sides. Dr Froud commented, "We set about exploring the implications of this and how it might change conclusions in research. We conducted several experiments using real trial data and it seems using Pythagoras' theorem makes a material difference. It helps to identify the point at which a patient has improved with more consistency and accuracy than other methods commonly used. "The moral of the story is that before you throw out the old stuff in the attic - just go through it one last time - as there may be something in there that is still relevant and useful," Dr Froud added. ]]> <![CDATA['Anti-diabetic drug may cure tuberculosis']]> https://biospectrumindia.com/news/95/4788/anti-diabetic-drug-may-cure-tuberculosis.html https://biospectrumindia.com/news/95/4788/anti-diabetic-drug-may-cure-tuberculosis.html Fri, 19 Dec 2014 14:37:00 +0530 A new research led by an Indian-origin scientist at the Singapore Immunology Network (SIgN), have discovered that Metformin (MET), a drug for treating diabetes, can also be used to boost the efficacy of TB medication without inducing drug resistance. "Using MET as an adjunct treatment for TB is very promising since this drug interferes with the biochemical pathway essential for the bacteria's survival and does not promote the development of drug resistance," said lead scientists Dr Amit Singhal, Project Leader and Prof Gennaro De Libero, Principal Investigator at SIgN. "MET is also a very cheap and safe drug with no adverse effect on non-diabetic patients. This would likely shorten clinical trials and we are confident that a better and affordable tuberculosis (TB) treatment will be made available soon," said Dr Singhal. ]]> <![CDATA[Roche to acquire Dutalys]]> https://biospectrumindia.com/news/95/5648/roche-to-acquire-dutalys.html https://biospectrumindia.com/news/95/5648/roche-to-acquire-dutalys.html Fri, 19 Dec 2014 13:09:08 +0530 Roche has announced that it has agreed to acquire Austria-based Dutalys GmbH, a privately held biotechnology company. Dutalys specializes in the discovery and development of fully human, bi-specific antibodies based on their proprietary DutaMab technology. The bi-specific antibodies developed with this platform are designed to provide novel, best-in-class molecules for several therapeutic areas. This deal further highlights Roche's leadership in the development of therapeutic antibodies. Under the terms of the agreement, Roche will make an upfront cash payment of $133.75 million to shareholders and make additional contingent payments of up to $355 million based on the achievement of certain predetermined milestones. "The platform developed by Dutalys is a breakthrough technology, and we are excited about integrating it within Roche. It strengthens our R&D capabilities in delivering bi-specific antibodies, which have the potential to create transformational new medicines,"said Mr John C Reed, head of pharma research and early development, Roche. "We are delighted to have found a partner who has the capability to fully leverage our technology for maximum patient benefit. DutaMabs are suitable for the treatment of numerous disease mechanisms and therapeutic targets, and we are very much looking forward to developing diverse novel therapeutics within the Roche R&D team," said Mr Roland Beckmann, co-founder and CSO of Dutalys. ]]> <![CDATA[Merck buys another biotech firm ]]> https://biospectrumindia.com/news/95/5654/merck-buys-another-biotech-firm-.html https://biospectrumindia.com/news/95/5654/merck-buys-another-biotech-firm-.html Fri, 19 Dec 2014 13:08:09 +0530 Merck has acquired OncoEthix, a Swiss biotechnology company, to enhance its growing cancer drug pipeline, says reports. The company will pay OncoEthix $110 million upfront and an additional $265 million upon the achievement of clinical and regulatory milestones. With the purchase, Merck gained OTX015, a BET (bromodomain) inhibitor that is currently being studied for the treatment of hematological malignancies and advanced solid tumors. A Phase I trial evaluating OTX015 in five different solid tumors was initiated last month. "Oncology is a priority area of focus for Merck and the acquisition of OncoEthix supports our strategy to prioritize the development of innovative molecules with the potential to improve the treatment of advanced cancers," said Dr Roy Baynes, senior vice president, global clinical development, Merck Research Laboratories. He added, "The potential first-in-class oral BET inhibitor, OTX015, has demonstrated early promising activity in hematological cancers and strategically complements our broad immuno-oncology development program." ]]> <![CDATA[India among top producers of pharmaceuticals: Report]]> https://biospectrumindia.com/news/95/5658/india-among-top-producers-of-pharmaceuticals-report.html https://biospectrumindia.com/news/95/5658/india-among-top-producers-of-pharmaceuticals-report.html Fri, 19 Dec 2014 12:58:50 +0530 According to a new report by CPhI, India will shortly be the World's second largest producer of drugs, but perhaps more significantly, will become the 8th largest pharma market by value-up from its current position of number 12. The report entitled: 'CPhI India Pharmaceuticals 2015 - Industry explorations' was prepared by CPhI in partnership with Global Business Reports (GBR). After relatively moderate growth in 2013, Indian pharma companies are extremely confident about the growth potential in both the near and medium terms. Outsourcing and exports are already pushing ahead at remarkable rates, with most companies reporting double digit pace growth. The report further states that two-thirds of India's pharma industry is still coming from the SME sector and with these companies increasingly expanding into international markets, the next few years promise to see a more mature and globally dominant Indian pharma industry. Biologics and biosimilars to represent 15 percent of Indian market value by 2020. In the near future, the most significant growth opportunities will come from generics. Within the coming years, there is a large volume of drugs coming off patent, including $90 billion in 2015 alone. The growth of generics, particularly across finished dosage forms, will continue to drive growth rates across India. Manufacturing of generics continues to be based in India and the report predicts this will expand rapidly. Biocon has really taken the lead for pharma India with its growth and development into an established biotech - it's currently the largest in Asia - having launched a number of monoclonal antibodies (e.g. ALZUMAb and BIOMAb EGFR), the world's first biosimilar (Trastuzumab) and is now the world's fourth biggest supplier of insulin through its INSUGEN brand. All companies from the report's research praised the new Government of India's efforts for actively supporting the pharma industry. ]]> <![CDATA[Merial buys Bayer's equine health products]]> https://biospectrumindia.com/news/95/4658/merial-buys-bayers-equine-health-products.html https://biospectrumindia.com/news/95/4658/merial-buys-bayers-equine-health-products.html Thu, 18 Dec 2014 17:01:10 +0530 Sanofi announced that Merial, its animal health company, has reached an agreement with Bayer HealthCare to purchase two of its equine health products, Legend/Hyonate (hyaluronate sodium) and Marquis (ponazuril). Legend/Hyonate is an injectable solution that treats noninfectious joint dysfunction in horses; and Marquis Antiprotozoal Oral Paste is the first FDA-approved treatment for equine protozoal myeloencephalitis (EPM), a disease that affects the central nervous system in horses. "We are pleased to add two top equine products to our global portfolio. Legend and Marquis are highly regarded by the horse community and further support our commitment to equine veterinarians, horse owners and trainers," said Merial CEO and Sanofi EVP Mr Carsten Hellmann. "This addition is one example of our strategy to invest in business opportunities that enable us to deliver innovative solutions to veterinarians across animal species." The purchase, expected to be finalized in early 2015, further broadens Merial's portfolio of leading products that improve the health and performance of horses. Legend/Hyonate is primarily sold in the US and Canada, but is available in more than 40 countries with the UK and Japan as important markets. Marquis is only sold in the US and Canada. Merial plans to make both products available to veterinarians in countries around the world. The acquisition is subject to customary closing conditions. ]]> <![CDATA[Dr Reddy's announce launch of Valganciclovir in US]]> https://biospectrumindia.com/news/95/4555/dr-reddys-announce-launch-of-valganciclovir-in-us.html https://biospectrumindia.com/news/95/4555/dr-reddys-announce-launch-of-valganciclovir-in-us.html Wed, 17 Dec 2014 16:20:15 +0530 Dr Reddy's Laborataries announced the launch of Valganciclovir Tablets USP 450 mg, a therapeutic equivalent generic version of VALCYTE (Valganciclovir) tablets in the US market on December 15, 2014, approved by the United States Food & Drug Administration (USFDA). The VALCYTE (Valganciclovir) tablets brand had US sales of approximately $440 million MAT for the most recent twelve months ending in October 2014 according to IMS Health. Dr Reddy's Valganciclovir tablets, USP in 450 mg is available in bottle counts of 60. ]]> <![CDATA[Suven Lifesciences receives 5 patents from 4 countries]]> https://biospectrumindia.com/news/95/4529/suven-lifesciences-receives-5-patents-from-4-countries.html https://biospectrumindia.com/news/95/4529/suven-lifesciences-receives-5-patents-from-4-countries.html Wed, 17 Dec 2014 14:28:48 +0530 Hyderabad-based, Suven Lifescinces has secured patents for its new chemical entities (NCEs) from Japan, China, NewZealand, and Isreal. The company has received two product patents from Israel and one each from the other countries. The NCEs have a potential to treat disorders associated with neurodegenerative diseases. The drugs were developed as therapeutic agents to be used in the treatment of cognitive impairment associated with neurodegenerative disorders like Alzheimer's, attention deficiency hyperactivity disorder (ADHD), Huntington's, Parkinson and schizophrenia diseases. The company, in a filing to the BSE said that, the patents includes the class of selective 5-HT compounds discovered by Suven. Earlier this year too, the company had received patents for its innovative products. With these new patents, Suven has two granted patents from Israel, 11 from Japan, 15 from China and 21 from New Zealand. "We are very pleased by the grant of these patents to Suven for pipeline of molecules in CNS arena that are being developed for cognitive disorders with high unmet medical need with huge market potential globally," said Mr Venkat Jasti, CEO of Suven. ]]> <![CDATA[Strides' new drug gets FDA nod ]]> https://biospectrumindia.com/news/95/4533/strides-new-drug-gets-fda-nod-.html https://biospectrumindia.com/news/95/4533/strides-new-drug-gets-fda-nod-.html Wed, 17 Dec 2014 13:18:52 +0530 Strides Acrolab has announced that the United States Food and Drug Administration (US FDA) has approved its Calcitriol softgel capsules used for the treatment of patients with kidney disease who have vitamin D deficiency. The company has received the approval for capsules in the strengths of 0.25mcg and 0.5mcg. According to the company, the product will be manufactured at its oral dosage facility at Bengaluru and marketed in the US market. The US market for generic Calcitriol softgel capsules is approximately $50 million, according to IMS data. ]]> <![CDATA[Evolva sells EV-035 series to Emergent BioSolutions ]]> https://biospectrumindia.com/news/95/4526/evolva-sells-ev-035-series-to-emergent-biosolutions-.html https://biospectrumindia.com/news/95/4526/evolva-sells-ev-035-series-to-emergent-biosolutions-.html Wed, 17 Dec 2014 12:39:55 +0530 Evolva Holding SA announced that Emergent BioSolutions Inc. has acquired Evolva's anti-bacterial programme, the EV-035 series. The lead compound in the EV-035 series is the broad-spectrum antibiotic GC-072, which is being developed with US government biodefense funding. For Evolva, this transaction is worth up to $70.5 million plus royalties. GC-072 has shown efficacy in both in vitro and in vivo studies against a wide range of bacterial pathogens, most notably Burkholderia pseudomallei. This bacterium causes the disease melioidosis and is regarded as a potential bio-threat agent. The preclinical development of GC-072 is funded by the Defense Threat Reduction Agency (DTRA) of the U.S. Department of Defense. Evolva and Emergent are working closely with DTRA on the transfer of the funding contract to Emergent, and expect this process to be completed within the next few weeks. Evolva will receive from Emergent an upfront payment of $1.5 million, an additional $4 million after the US government approves transfer of the GC-072 contract to Emergent, development milestone payments up to $65 million, and tiered royalties up to a maximum of 10 percent on product net sales generated from the EV-035 programme. This transaction completes Evolva's strategic shift of focus towards ingredients for health, wellness and nutrition. Neil Goldsmith, CEO of Evolva, said "Emergent has extensive experience partnering with the U.S. government through its development, manufacture, and delivery of medical countermeasures, and is perfectly placed to make the EV-035 series a success. This is financially an attractive deal for Evolva, both in the short term and the longer term." ]]> <![CDATA[R&D for public good: Breaking Stereotypes! ]]> https://biospectrumindia.com/features/95/4481/rd-for-public-good-breaking-stereotypes-.html https://biospectrumindia.com/features/95/4481/rd-for-public-good-breaking-stereotypes-.html Wed, 17 Dec 2014 09:45:00 +0530 Taxpayer's money in science will now have more accountability with equal accessibility to the outcome. Taking a revolutionary step towards the realization of long term goals, the Department of Biotechnology (DBT) and the Department of Science and Technology (DST) under the Ministry of Science and Technology have decided to bring an open and unrestricted access to its funded research. As one of the important scientific agencies, the function of the departments, as they mention, has been to support basic, translational and applied scientific research through the creation of suitable infrastructure, by providing funding to individual scientists, institutions and start-ups, and through any other means deemed necessary. Therefore, the new policy if implemented soon shall lead to new pathways The former science and technology minister, Dr Jitendra Singh had reiterated in the Parliament that once the policy is adopted, researchers will have an unrestricted access to the papers arising out of the publicly funded research without requiring to pay for it. "Several concerns such as payment of publication charges, copy right issues, freedom to choose the journal, quality etc have been raised. These will be addressed while framing the open access policy, he had assured.Since all funds disbursed by the departments are public funds, it is important that the information and knowledge generated through the use of these funds are made publicly available as soon as possible. While the recipients of funding are expected to publish their research in high quality, peer-reviewed journals, both the departments have affirmed that the intrinsic merit of the work, and not the title of the journal in which an author's work is published, would be considered in making future funding decisions. Talking about the impact created by open access policy for published work, Dr Pawan Dhar, senior scientist and professor, Department of Life Sciences, Shiv Nadar University mentioned, "It is a very important for unmet need of the Indian scientific community. So, earlier the better! I don't think the OA policy will harm anyone. It is not a new concept. It has already been started, standardized and implemented in the US. In the OA model, copyright remains with the author of the publication. Using the old model, the copyright is transferred to the publisher." Maximizing the distribution of these publications by providing free online access by depositing them in open access repository is the most effective way of ensuring that the research it funds can be accessed, read and built upon. This, in turn, will foster a richer research culture. Grantees can make their papers open-access by publishing in an open-access journal or, if they choose to publish in a subscription journal, by posting the final accepted manuscript to an online repository. The Indian Council for Agriculture Research (ICAR) adopted the policy few years back and has been improving the process of sharing data and compliance. The institutes have been asked to deposit their research publications in a central repository. Says Dr Swapan Dutta deputy director general (crop sciences), ICAR, "Access to journals and the suggestions from public have increased since the open access policy at ICAR. The information about new varieties developed, technological interventions, government funding have benefitted the farmers and researchers alike to increase the yield." The Council for Scientific and Industrial Research (CSIR) through its open access policy has asked for all research papers published from CSIR laboratories and supported by a grant from CSIR to be deposited via the full text and the metadata (electronically archived data) of the paper in an institutional repository. It has been one of the leading scientific agencies to first open up though it was specifically on a global project initiated in India. Dr Samir Brahmachari, former director general, CSIR who was the brain behind Open Source Drug Discovery (OSDD) initiated in 2008, says that initiative has shown tremendous scope for future. He mentioned, "The open innovation in a country like India where we have so many young minds, serves as a great platform to express ideas and partner. At present close to 6,000 people across the globe are a part of the project and we are moving towards a new direction. Already clinical trials have been initiated on a TB molecule in partnership with TB Alliance." Boost to translational research The outcomes of the years of sweating research in labs should defiantly mean much more than just publications. More product outcomes from the labs have to reach the common man. Then only we can really justify the funding sought for the research. The decision to open up could also pump up such efforts as the like-minded researchers can get together to build upon common ideas. Exchange of ideas and technology will surely be good for translation." As per Dr William Selvamurthy, retired senior scientist, DRDO and now director general, Amity Directorate of Science and Innovation, "CSIR Started open access policy. Leprosy, TB bring on a single platform. Recognition gets a score. Ultimately when produced, the product recognition has to be shared. Look at Lancet papers, the 50 authors are there. While the international agencies such as Welcome Trust are promoting proposals that require sharing, we have been slow in implementing it. The problem with researchers is that they are introverts. They must open up and come out to share."Asked about the challenges, Dr Swapan Dutta remarked, "This is a huge country with variable agriculture policies at the state level. It is important to keep the federal policies in alignment with the foresight on agricultural methods in next 11-15 years. As PM Modi had mentioned, there is need to bring awareness to farmers. Besides that I feel the IP policy and profit sharing is important. It has not been practised in India so far. Therefore, it is important to keep the guidelines clear while implementing the open access policies." Now the question is whether the industry gets benefitted from this. Dr Pawan Dhar feels that it might help the companies at lowest level of the Pyramid, He says, "Well established industry players are already accessing the papers by paying a nominal fee. Compared to the academia, perhaps industry will not benefit more, except in case of start-ups with minimal R&D budget and small not-for-profit organizations." A young CEO of a start up also seemed to be in full agreement with Mr Dhar. The policy will definitely help the smaller fishes in the pond as we will not have to shell out money for this besides it could also help them to gain fresh ideas without any hassles whatsoever in the past. The big companies with huge R&D programs might too benefit but it is not so equally bif for them as for us, he told BioSpectrum. Besides opening up of knowledge boxes, the other steps that can be taken to increase the sharing of scientific knowledge for the overall good of society too must be done. The regular multi-disciplinary research efforts, advocacy workshops and capacity building of scientific and technical personnel too are very important. ]]> <![CDATA[Abbott completes acquisition of Veropharm]]> https://biospectrumindia.com/news/95/4458/abbott-completes-acquisition-of-veropharm.html https://biospectrumindia.com/news/95/4458/abbott-completes-acquisition-of-veropharm.html Tue, 16 Dec 2014 16:32:46 +0530 Abbott has had a presence in Russia for nearly 40 years and, in line with its long-term commitment to growing global healthcare markets and capabilities, the company is committed to providing a reliable supply of its healthcare products to Russian patients. Through this acquisition, Abbott establishes a manufacturing footprint in Russia through Veropharm's production facilities, which include a new manufacturing facility currently under construction. Abbott also obtains a portfolio of medicines that is well aligned with its current pharmaceutical therapeutic areas of focus in women's health, central nervous system, cardiovascular and gastroenterology, while adding an offering in the field of oncology and pharmaceutical R&D capabilities for Russia. Abbott acquired control of Veropharm for 16.7 billion rubles (or approximately $305 million dollars) through its purchase of Limited Liability Company Garden Hills, the holding company that currently owns approximately 98 percent of Veropharm. Abbott will fund the transaction with cash on the company's balance sheet. The transaction will not impact ongoing earnings-per-share guidance for 2014. ]]> <![CDATA[Global Ebola relief effort not reaching rural communities ]]> https://biospectrumindia.com/news/95/4451/global-ebola-relief-effort-not-reaching-rural-communities-.html https://biospectrumindia.com/news/95/4451/global-ebola-relief-effort-not-reaching-rural-communities-.html Tue, 16 Dec 2014 16:21:45 +0530 Unprecedented levels of donation to support Ebola-struck Sierra Leone are bypassing many of the places where funding is urgently needed, claim two UK-based experts. The independent experts, Dutch sustainability scientist, Dr Robert Verkerk, and Sierra Leonean crisis management expert, Mr Morris Marah, have just returned from a one-week capacity assessment mission requested by the Ministry of Information and Communications, Sierra Leone. Dr Verkerk and Mr Marah were invited by Sierra Leone's Minister of Information and Communications, Hon Alpha Kanu, to assess capacity and requirements for the fight against Ebola in the Port Loko district. The district, for which Mr Kanu also acts as Member of Parliament, is one of the hardest hit outbreak areas in the country. Last week saw a decline in numbers of reported Ebola cases in the Port Loko district from the peak in October. The availability of funds to rapidly build and resource 20 holding and community centres in the district is critical to Mr Kanu's ambitious bid to oust Ebola from the district by the end of the year. "It's a bitter pill to swallow for many Sierra Leoneans," said Dr Verkerk on his return today, "Local people listen daily to radio news reports saying that the British are donating at unprecedented levels to support the effort against Ebola. Yet this spend is being concentrated in very limited areas, like the British-built facilities, only one of which is ready." "The majority of Sierra Leone government-run facilities," added Dr Verkerk, "have yet to receive a penny and are struggling to find funds for things as commonplace as tarpaulin for walls and roofing, and glue for the gauze windows to make them mosquito-proof." "There is complete disparity in how the funding is being distributed," explained Mr Marah. "We've visited many of the holding and community care centres for Ebola victims in the Port Loko district. We didn't find a single Sierra Leone government facility that had received any external funding despite all the money pouring in from well-meaning donors around the world." The two experts stressed that these holding centres are playing a key role in the fight against Ebola because they allow infected individuals to be rapidly isolated from their communities. This role is being coordinated by British army personnel, the WHO and CDC, who are working closely with Sierra Leone police, army and medical staff. Commenting on these centers, Mr Marah said "It's critical that they don't turn into death camps - places where infected people are brought and simply left to die, just because resources aren't there. The British-built Kerrytown facility is a long way from Port Loko and the Port Loko facility probably won't be functional until the new year." ]]> <![CDATA[Evolva completes Allylix acquisition]]> https://biospectrumindia.com/news/95/4421/evolva-completes-allylix-acquisition.html https://biospectrumindia.com/news/95/4421/evolva-completes-allylix-acquisition.html Tue, 16 Dec 2014 12:54:45 +0530 Evolva Holding announces the completion of the acquisition of Allylix, after which the aquired comapany will be a wholly-owned subsidiary of Evolva. This transaction is in return for an overall consideration of 46 million newly-issued Evolva shares (c. 14.1 percent of Evolva post transaction). Part of these shares, currently estimated at approx. 6 million shares, will be sold over a period of time after closing, to offset certain liabilities and transaction expenses of Allylix. Shares allocated to the Allylix security holders will be subject to a staggered lock-up, such that the shares will be released in twelve tranches of approx. 3 million shares each, during the first year after the closing of the transaction. The SIX Swiss Exchange has approved the listing of the new Evolva shares and trading in the new shares on the Main Standard of SIX is expected to commence soon. ]]> <![CDATA[Pfizer acquires Opko's growth hormone ]]> https://biospectrumindia.com/news/95/4661/pfizer-acquires-opkos-growth-hormone-.html https://biospectrumindia.com/news/95/4661/pfizer-acquires-opkos-growth-hormone-.html Tue, 16 Dec 2014 12:44:16 +0530 Pfizer is buying access to Opko Health's investigational long-acting human growth hormone, hGH-CTP in a deal worth $570 million, as per reports. hGH-CTP, which is currently being tested for growth hormone deficiency in Phase II (children) and Phase III (adults), could offer a huge benefit to patients as it comes with once-weekly instead of once-daily injections. Reportdly, the company is shelling out $295 million upfront and an extra $275 million on achievement of regulatory milestones for an exclusive global license to hGH-CTP. Opko will lead the clinical activities and will be responsible for funding the development programs for the key indications, while Pfizer will be responsible for all development costs for additional indications as well as all post-marketing studies. The drug giant will also fund commercialisation activities for all indications and lead the manufacturing activities covered by the global development plan. "The global growth hormone market is currently valued at more than $3 billion, and it believes hGH-CTP has the potential to be the best in class long-acting growth hormone product," said the company in a statement. ]]> <![CDATA[PrajHiPurity Systems adds new products to its portfolio]]> https://biospectrumindia.com/news/95/4562/prajhipurity-systems-adds-new-products-to-its-portfolio.html https://biospectrumindia.com/news/95/4562/prajhipurity-systems-adds-new-products-to-its-portfolio.html Tue, 16 Dec 2014 12:43:00 +0530 PrajHiPurity Systems (PHS) has introduced 'BioWiz', a Smart Bioreactor, which will help the biopharma industry meet the various bio processor requirements in laboratory, pilot, and commercial units. BioWiz Bioreactor benchmarks international standards and delivers superior operational features and advantages required in the global pharmaceutical industry. Some of its key features are cost effective design as per International Standards like cGMP, GEP, and GDP, 'Golden Batch' concept for real time comparison of process parameters, advance automation - PLC-SCADA-based system, in-built safety parameters and web based remote monitoring. Commenting on the BioWiz Bioreactor, Mr Gajanan Nabar CEO and MD of Praj Industries and Mr Mihir Mehta, BU head of PHS said, "A well-engineered process solution plays a significant role in defining efficient functioning of the production facility. High Purity industries like pharmaceuticals, biotechnology, healthcare and cosmetics are characterized by stringent demands on sterile and hygienic design and engineering. Manufacturing systems are required to meet high quality standards and guidelines set by international authorities like ISPE or ASME BPE. It is in this context that the BioWiz Smart Bioreactor has a major impact on productivity, quality and profitability of any manufacturing plant." PHS also introduced new models of its 'Glacier' Water System. It is used to generate pure, sanitized water for pharma and biotech applications. The new system comes with advanced features like 'one touch' sanitization operation, complete plug and play operation, easy access for O&M with reduced footprint. Introducing 'Glacier' Mr Nabar said, "This is the outcome of our continued R&D to offer best-in-class high purity water system with highest hot water sanitization cycles. It's plug and play feature saves time and energy." ]]> <![CDATA[Bristol-Myers Squibb Foundation awards nine grants to support care for patients with Hepatitis B and C in India and China]]> https://biospectrumindia.com/news/95/4300/bristol-myers-squibb-foundation-awards-nine-grants-to-support-care-for-patients-with-hepatitis-b-and-c-in-india-and-china.html https://biospectrumindia.com/news/95/4300/bristol-myers-squibb-foundation-awards-nine-grants-to-support-care-for-patients-with-hepatitis-b-and-c-in-india-and-china.html Mon, 15 Dec 2014 18:07:52 +0530 The Bristol-Myers Squibb Foundation today announced nine new grants totaling more than $3.5 million to strengthen efforts in India and China in the fight against hepatitis B virus (HBV) and hepatitis C virus (HCV) infection by focusing on the most vulnerable, high-risk patient populations. The multi-year grants were made through the Foundation's Delivering Hope initiative, which has supported more than 40 projects in India and China since 2002. These new grants align with the World Health Organization's (WHO) strategies for reducing the incidence of HBV and HCV infection through early diagnosis and screening of high-risk populations, including intravenous drug users and patients co-infected with HIV and/or tuberculosis. Several focus on increasing awareness about disease transmission among health care providers who care for HBV- and HCV-infected patients, who also are considered at-risk for contracting viral hepatitis. Viral hepatitis is an urgent public health issue in Asia. In India and China together, it is estimated that more than 123 million people are infected with chronic hepatitis B and about 60 million with hepatitis C. Although progress has been made in introducing national policies to control the spread of HBV and HCV, community and general awareness is considerably low. When left untreated, viral hepatitis infections result in liver failure and chronic liver disease that can create a significant burden on families and society. "Delivering Hope continues to increase its focus on HBV and HCV in India and China India, the two countries that have the highest incidence of viral hepatitis worldwide," said John Damonti, president, Bristol-Myers Squibb Foundation. The Foundation awarded grants for the following projects in India: â€¢ All India Institute of Diabetes and Research - A pilot program in Mehsana and Sabarkantha, two rural districts in the state of Gujarat that have experienced HBV outbreaks, will expand HBV testing in public health care institutions, make vaccinations more widely available through a network of nongovernmental organizations and hospitals. â€¢ MAMTA - Health care providers, including doctors, nurses, lab technicians and others who come into direct contact with hepatitis patients, will receive training in HBV and HCV risk assessment, disease prevention and risk management. â€¢ United Way of Mumbai - To help prevent disease in the hardest-hit and most-at-risk populations, medical interventions and extensive community education will take place in 18 slum areas in Mumbai. â€¢ SAMARTH - As new grantees join the Foundation's Delivering Hope initiative in India, proper monitoring and evaluation will ensure that program goals are achieved. SAMARTH will conduct training activities to strengthen partners' ability to self-monitor and evaluate their program's progress and provide objective information about program functioning, methodologies, effectiveness and impact, and identify potential gaps. In addition, the Foundation awarded a grant to the World Hepatitis Alliance to develop a new model of patient group creation aimed at physicians who treat viral hepatitis and engage them in creating and sustaining patient support groups. These groups play a large role in advocacy efforts that have changed health care policies and practices for a range of diseases around the world. The World Hepatitis Alliance will develop an e-learning tool comprised of a video course and a text-based tool kit that will focus on the importance of advocacy to promote viral hepatitis awareness and prevention, the need for patient groups to be integral to advocacy, advantages to physicians of having strong patient groups, provide information about creating a patient group and supporting existing groups and map out support available from the World Hepatitis Alliance and other sources. These learning materials will be housed on the World Hepatitis Alliance website and will be available to be hosted on other websites, including those operated by major international hepatology societies, to ensure wide distribution. The project will include China and India, but is more broadly aimed at the world. ]]> <![CDATA[Biocon to set up its new unit in AP]]> https://biospectrumindia.com/news/95/5226/biocon-to-set-up-its-new-unit-in-ap.html https://biospectrumindia.com/news/95/5226/biocon-to-set-up-its-new-unit-in-ap.html Mon, 15 Dec 2014 13:22:48 +0530 Biocon Chairperson and Managing Director (CMD) Dr Kiran Mazumdar-Shaw met Andhra Pradesh chief minister Mr N Chandrababu Naidu and informed him of the company's plans to set up a manufacturing unit in Vizag in the next six months, as per reports. During the meeting, Dr Kiran gave a presentation to Mr Naidu on e-healthcare and its advantages. She briefed him about telemedicine and e-diagnosis and added that it would be beneficial to people living in rural areas who do not have access to healthcare services. With this facility, they would not have to travel to cities for treatment. The company is already rolling out 50 centers in Odisha and 100 centers in Rajasthan on a pilot basis. Reportedly, the chief minister in response said that the state is prepared to help set up 100-200 pilot centers. ]]> <![CDATA[Wellness Genomics: Genomics for health and wellness]]> https://biospectrumindia.com/features/95/7050/wellness-genomics-genomics-for-health-and-wellness.html https://biospectrumindia.com/features/95/7050/wellness-genomics-genomics-for-health-and-wellness.html Mon, 15 Dec 2014 12:02:09 +0530 Genomics or genome sequencing was earlier synonyms with finding out the risk of getting a disease or more so a deadly disease. With genome sequencing becoming cheaper and affordable, many bioinformatics companies are offering services which utilize DNA-based information to treat ageing, managing or identifying the wellbeing or even the sports which a person should pursue as per the genetic information and ultimately trying to add up healthy approach to a one's life. Genetic information can be utilised for a much healthier life. This has given rise to a term, "wellness genomics." Wellness genomics the new trend? "In General, health and wellness has gained a lot of recognition in consumer conscience in recent years. Personalized health and wellness through genetics is the next frontier. At Xcode, we are already seeing a significant awareness among consumers about genetics and its role in disease prevention, health and fitness. It's a trend that is growing quite rapidly. Our 100andLife program, which is a DNA-based holistic health and wellness program, has found significant interest among corporate as well as individual customers," said Mr Abdur Rub, CTO, Xcode Life Sciences, a Chennai-based, bioinformatics company. It has recently launched come alive, where DNA information is utilised to gather information like collagen elasticity, etc, and that is being utilized for treating ageing. It is a DNA based anti-ageing solution in which uses body's defences to slow down the aging process. The service is being offered at a nominal fee. The company also has offer services in the pipeline like lifelong wellness which analyse genes for health risks and metabolic variables to give an effective nutrition and fitness plan. Echoing similar views Ms Anuradha Acharya, CEO, Mapmygenome said that wellness is going to be bigger and genome is definitely a piece of wellness industry. Mumbai-based Mapmygenome also offers DNA based tests to find the right sport/fitness activity for an individual and many other services like Gynaecmap a women's wellness predictive panel. This revolutionary test gives the genetic vulnerabilities to key functions of women's health. The company also offers Oncomap, a DNA-based test that predicts the genetic risk of developing cancer. By combining genetic report and health history with genetic counseling the company provides actionable steps for individuals and their physicians towards a healthier life. The cost of these tests typically range from Rs 5000-25000, and like any other thing can also be purchased online. Recently, mapmygneome, partnered with online retailer snapdeal.com for selling its kits. Similarly, some of the companies are partnering with hospitals to reach out to people. Like Mapmygneome India has partnered with CARE Hospitals Group to offer personal genomics and molecular diagnostics at the hospital. Also, Positive Bioscience has partnered with Medanta-The Medicity to launch India's first Personal Genomics Clinic, which offers state of the art facilities and services in preventive healthcare and personalized medicine within the country.Prospect in India How is wellness genomics industry in India? "Very new at this place will take some time to actually take it off", said Ms Acharya. Elaborating further on this Mr Rub said, "The wellness genomics market in India is nascent but expanding rapidly. Our company, Xcode Life Sciences has had good success among various customer segments. We anticipate the market to grow significantly once the marketing efforts ramp up in the coming months. A significant increase in preventable lifestyle-related conditions among the workforce has given rise to a need for effective preventative health tools, where genetic-health and wellness fits in perfectly. A significant number of Xcode's customers are corporates." Future trends Speaking of the future prospect in wellness genomics, Mr Rub said, "The downward trend in the cost of genetic sequencing will continue. The industry is eagerly anticipating the $100 human genome, which will open the flood gates for large scale whole genome data, which will lead to a dramatic increase in number of discoveries and an explosion of niche products that are matched to consumer genotypes. With a significant first mover advantage in India, Xcode Life Sciences is well positioned to ride this trend. We have multiple products, partnerships in place which will be rolled out in the near future. Thus, it is becoming increasingly evident that personalised medicine could be the next era in the healthcare industry." Defying aging? With the help of personal genomics is it possible to defy ageing? Or live long? Answering to the question, Mr Rub said, "We are living in unprecedented times. The pace and magnitude of scientific progress in biomedical sciences is phenomenal. Given the developments and underlying trends it is plausible that aging can be significantly slowed, if not arrested- in the not so distant future. Personalized nutrition, fitness and other interventions will play a significant role in achieving that goal. At Xcode, the goal to achieve a long, healthy and youthful life underlines our product philosophy and is a recurrent theme across all our product. It will offer a range of personal genomic services that predict diseases and pinpoint the right medicine for an individual." Our genome is the blue print of life and ultimately defines what our life is going to be as far as health and disease are concerned. "Genetics is a portion of what your life is going to be and you can made changes in your lifestyle and that will allow you to live long and healthier life. Preventive genomics can add 10 years to a healthier life," adds Ms Acharya. Exploring reasons for longevity However there are some other researchers who are trying to find out the molecular reasons for the longevity. A team of scientists at the Institute of Genomics and Integrative Biology (IGIB), are trying to sequence the genome of centenarians to decode the secrets of longevity. The project, funded by CSIR, titled 'Wellness Genomic Project' is led by Prof. Samir K Brahmachari (SKB) former DG, CSIR along with his colleagues Dr Sridhar Sivasubbu and Dr Vinod Scaria, scientists at IGIB. Many other countries like US UK, Japan New Zealand are also working on decoding the secrets of longevity. Speaking about the project, Prof. Samir K Brahmachari said, "We wanted to be a part of Xprize Archon genomics so that we have access to all the data. Unfortunately, the Xprize got closed. But we decided to sequence the Indian genome, and 91 in India is as good as 100 in Japan. We are trying to find out what signals longevity by studying their genome.'' Life expectancy in India has increased considerably due to the advancement in science and healthcare. It was 30 in India at the time of Independence and it is now 65. In the US it is 69. And this can be improvised further by understanding the genome at the molecular level. They have collected 88 samples (of people aged 91 or above) from across India, out of which 16 are sequenced so far. They have formulated few theories. Prof. SKB elaborated further, "Idea is to find something common in these genes. Some special types of genes, or other genes whose activity is slightly higher than the others. We are looking at C.elegans genes which are shown to be related to longevity, are these genes different here? If we can find a marker or some particular metabolism process that allows longevity. Sequencing is not an easy task, and sequencing the genome of centenarians is even more difficult, as it is very hard to collect blood samples from them. So working with small samples, with the present day technology, and to analyse large genomic data, are some of the challenges in this project. This is the first of its kind study in India. Earlier, Bangalore-based Avesthagen had launched a Parsee genome project with an investment of Rs 125 crore. Parsee community has a life expectancy of 75 years as opposed to 60 for Indians. "The Parsis tend to have a higher longevity than the rest of the Indian population, and most people live well into their 90s. A multitude of factors could give rise to a trait of longevity in a population. These could be genetic, or environmental (such as lifestyle, dietary habits etc), or more likely a combination of both. We are currently focussing on three disease groups-cancers, metabolic disorders and neurodegenerative diseases. Using parallel genomic, proteomic and metabolomic approaches, a massive amount of data is being collected. For example, whole genomes of 11 individuals have been sequenced so far. These data will be analysed and integrated with the environmental factors that we have collected in our questionnaires, and cumulatively these could give us hints about a complex trait as longevity. That is one of our long term goals," said Dr Villoo Morawala-Patell, Founder and CMD, Avesthagen. We hope after sequencing 30 genomes we will have statistically significant data, sums up Prof. SKB. If the project is successful, it would pave the way for long, and healthy living. ]]> <![CDATA[Biocon, Sun Pharma presented India Innovation Award 2014]]> https://biospectrumindia.com/news/95/6018/biocon-sun-pharma-presented-india-innovation-award-2014.html https://biospectrumindia.com/news/95/6018/biocon-sun-pharma-presented-india-innovation-award-2014.html Mon, 15 Dec 2014 11:14:00 +0530 Bangalore based Biocon Ltd. and Sun Pharmaceutical Industries Ltd. have been awarded the Thomson Reuters's India Innovation Awards 2014 in the corporate pharmaceutical category. The intellectual property & science business of Thomson Reuters also launched its 2014 State of Innovation India Report, which showcases twelve leading sectors and analyses the innovation in each based on patent activity. The awards are presented on the basis of size of portfolio of patents filed by the company in the year, their success rate, extent of globalization and influence of innovation, said Bob Stembridge, Chair of Patent and Trade Mark Group, Thomson Reuters. The award "validates the work that Biocon is doing in our pursuit to ding solutions that heal the world," Kiran Mazumdar Shaw, CMD, Biocon. Dr Rajamannar Thennati, Head-R&D, Sun Pharma, said, "We are focused on finding solutions to complex scientific challenges, environmental safety and creating an intellectual asset for sustained growth." According to the State of Innovation India report, pharma sector stood second in innovation in India followed by hi-tech engineering. Among the top ten patent filers in India, eight are India organisations. Innovations in India has been steadily increasing in recent years. The number of patents filed by Indian companies has grown from merely less than 2000 in 2004 to over 7000 in 2013. "India is an important global innovation hub, with both local and global organistions conducting critical R&D activities in India," said Pradeep Lankapalli, MD, India and Head of global operation centers, Thomson Reuters. ]]> <![CDATA['Innovation today is fast, messy, and global']]> https://biospectrumindia.com/news/95/4167/innovation-today-is-fast-messy-and-global.html https://biospectrumindia.com/news/95/4167/innovation-today-is-fast-messy-and-global.html Sat, 13 Dec 2014 16:09:00 +0530 India and Israel need to find a way to create more meeting places where ideas can be exchanged and collaborations forged made for greater cooperation between the two countries, said Mr Israel Makov, chairman, Sun Pharmaceuticals, the first Israeli chairperson of a major Indian company. Mr Makov was speaking at the India-Israel Innovation Colloquium, organized by Confederation of Indian Industry (CII), Ananta Centre (formerly Aspen India), and the Tel Aviv University (TAU). The colloquium was organized under the joint chairmanship of Israel Makov, chairman, Sun Pharmaceuticals, and S Ramadorai, chairman, National Skill Development Agency, Government of India. Mr Makov said the Israeli government is trying to create such opportunities across the world so that India can tap the knowledge Israel has to offer and Israel cad look at opportunities here. "There are opportunities for both sides. Israeli firms are small and in India they can learn how to operate on a large scale. Indian companies can come to Israel and gain the knowledge and expertise that Israeli firms have. Israeli companies are more innovative," he said. Mr Manoj Kohli, MD, Bharti Enterprises, said that Israel held a unique place in the world. "They live in crisis all the time, they have fantastic courage, and have the bent of mind to innovate," he said. He also mentioned five key characteristics needed to innovate successfully. "Crisis, courage to go through with innovations, constant alignment with partners, agility and ability to move fast, and constant communication and celebration of success are the key characteristics for successful innovation. Innovations are sustainable if they are positive," he added. Prof Yesha Sivan, executive director, The Coller Institute of Venture, Tel Aviv University, pointed out that the ecosystem of innovation today is fast, messy, and global, while the current trend among companies is to use innovation platforms to get ahead. He attributed the success to Facebook and its ability to capitalize on its innovation platform. He said of the four key factors that drive funding of innovation, that is government authorities, institutional investors, venture capitalists, and entrepreneurs, the last three are global in nature. "Only government authorities remain local, and they thus have a major role to play in building up the right systems. Laissez faire is impossible," he said. Mr Jamshyd Godrej, co-chair, India Israel Forum and CMD, Godrej & Boyce Manufacturing, said the India-Israel Forum had led to huge interest of Israelis in India, and of Indians in Israel. He pointed out that the two countries already share deep ties in the areas of agriculture, defence, and information technology. "There is also great interest in the area of solar energy that our Prime Minister Narendra Modi has been talking about," he added. The Israeli Consul General in Mumbai, Mr David Akov, said he was pleased to see how an idea he had heard in Tel Aviv six months ago had materialised into a colloquium and a vibrant meeting to promote major goals of the two countries. "India and Israel are open societies and democracies which add to the chaos, but which also make for dynamic societies," he said. Earlier, S Ramadorai, co-chair of the colloquium, and chairman, National Skill Development Agency, welcomed the delegates to the day-long event. He said he had been impressed by the innovative abilities and disruptive technologies displayed at Tel Aviv University, which he had visited a few months ago. Pointing out that IIT-Bombay and Tel Aviv University had established an undergraduate exchange programme, he added, "Indian firms are moving up the value chain and should tap the vibrant innovation ecosystem of Israel." Indo-Israel Innovation Colloquium held in The Financial Capital of India- in Mumbai ]]> <![CDATA[First ever maize genomes mapped]]> https://biospectrumindia.com/news/95/7410/first-ever-maize-genomes-mapped.html https://biospectrumindia.com/news/95/7410/first-ever-maize-genomes-mapped.html Fri, 12 Dec 2014 17:09:39 +0530 Delivering results in under a week for each genome, the platform has constructed very detailed and highly accurate assemblies that have led to the discovery of new genes. Previous attempts at mapping took months and years. The platform is proven to allow quick and accurate re-construction of reference genomes for even the most complex genomes like maize, wheat, and other crops critical to the world's food supply. As reference genomes are vital tools in the discovery of the optimal genetic makeup of crops, DeNovoMAGIC's speed and accuracy now allows reference genome reconstruction to be a common practice in crop research and seed industry R&D. "Global food scarcity means that plant geneticists and breeders must produce better seeds much faster," said Dr Gil Ronen, NRGene's CEO. "Our genomic big data DeNovoMAGIC technology is already supporting them with the precise and relevant data required to boost their research toward gaining heartier yields." NRGene's genomic big data technology can quickly and efficiently produce more than 20 complex reference genomes a month, meaning its DeNovoMAGIC solution can triple the world's plant reference genome collection within a single year. ]]> <![CDATA[New drug kills malaria parasites in 48 hours]]> https://biospectrumindia.com/news/95/5236/new-drug-kills-malaria-parasites-in-48-hours.html https://biospectrumindia.com/news/95/5236/new-drug-kills-malaria-parasites-in-48-hours.html Fri, 12 Dec 2014 13:55:02 +0530 Researchers at the St Jude Children's Research Hospital have developed a new chemical compound that rapidly destroys malarial parasites. The compound, (+)-SJ733, a single dose of it has been shown to kill 80 percent of malaria parasites in the bloodstream of mice within 24 hours. Within 48 hours the parasite was completely undetectable. The researchers are now planning human trials. Laboratory evidence suggests that the compound's speed and mode of action work together to slow and suppress development of drug-resistant parasites. "Our goal is to develop an affordable, fast-acting combination therapy that cures malaria with a single dose," said lead author of the study Dr R Kiplin Guy,chair of the St Jude department of chemical biology and therapeutics. He added, "These results indicate that SJ733 and other compounds that act in a similar fashion are highly attractive additions to the global malaria eradication campaign, which would mean so much for the world's children, who are central to the mission of St Jude." The study is published in the proceedings of the National Academy of Science of the United States of America. ]]> <![CDATA[FDA approves Merck's HPV Vaccine]]> https://biospectrumindia.com/news/95/4041/fda-approves-mercks-hpv-vaccine.html https://biospectrumindia.com/news/95/4041/fda-approves-mercks-hpv-vaccine.html Fri, 12 Dec 2014 12:50:41 +0530 Merck has announced that the US Food and Drug Administration (US FDA) has approved GARDASIL 9 (Human Papillomavirus 9-valent Vaccine, Recombinant), vaccine, for use in girls and young women 9 to 26 years of age for the prevention of cervical, vulvar, vaginal, and anal cancers caused by HPV types 16, 18, 31, 33, 45, 52 and 58, pre-cancerous or dysplastic lesions caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58, and genital warts caused by HPV types 6 and 11. GARDASIL 9 is also approved for use in boys 9 to 15 years of age for the prevention of anal cancer caused by HPV types 16, 18, 31, 33, 45, 52 and 58, precancerous or dysplastic lesions caused by HPV types 6, 11, 16, 18, 31, 33, 45, 52 and 58, and genital warts caused by HPV types 6 and 11. "With GARDASIL 9, the medical and public health community now has the potential to help prevent 90 percent of cervical cancers caused by HPV. This is an extraordinary opportunity to even further reduce the burden of HPV-related diseases and cancers in males and females," said Dr Julie Gerberding, president, Merck Vaccines. GARDASIL 9 includes the greatest number of HPV types in any available HPV vaccine. ]]> <![CDATA[Merck to acquire Cubist for $9.5 billion]]> https://biospectrumindia.com/news/95/4045/merck-to-acquire-cubist-for-9-5-billion.html https://biospectrumindia.com/news/95/4045/merck-to-acquire-cubist-for-9-5-billion.html Fri, 12 Dec 2014 12:49:02 +0530 Merck has announced that it will acquire Cubist Pharmaceuticals in a deal worth $9.5 billion. "Cubist is a global leader in antibiotics and has built a strong portfolio of both marketed and late-stage pipeline medicines. Combining this expertise with Merck's strong capabilities and global reach will enable us to create a stronger position in hospital acute care while addressing critical areas of unmet medical need, such as antibiotic resistance,"said Mr Kenneth C Frazier, chairman and chief executive officer, Merck. "Combining with Merck is an exciting opportunity to accelerate Cubist's established leadership in antibiotics and deliver significant, certain and immediate value to shareholders," said Mr Michael Bonney, chief executive officer, Cubist. He added, "We have a deep respect for Merck, and it is clear that they share our commitment to addressing the growing, global problem we are facing in combating antibiotic-resistant bacteria. Under Merck's robust commercial platform, global reach and scientific expertise, we believe Cubist's programs can thrive. We're proud of the company that our team has built and are confident that Cubist's important mission and focus on significant unmet medical needs will continue." Merck expects the acquisition to add more than $1 billion of revenue to its 2015 base. Under the terms of the agreement, the company, through a subsidiary, will initiate a tender offer to acquire all outstanding shares of Cubist Pharmaceuticals. The companies expect the transaction to close in the first quarter of 2015. ]]> <![CDATA[Patent expiries: Pharma cos to suffer $65 bn drop in sales by 2019]]> https://biospectrumindia.com/news/95/4008/patent-expiries-pharma-cos-to-suffer-65-bn-drop-in-sales-by-2019.html https://biospectrumindia.com/news/95/4008/patent-expiries-pharma-cos-to-suffer-65-bn-drop-in-sales-by-2019.html Thu, 11 Dec 2014 16:30:11 +0530 The company's report states that the drug makers hit hardest will include Otsuka, Eli Lilly, and AstraZeneca (AZ), with a significant proportion of losses coming in the Central Nervous System (CNS) treatment sector. Mr Adam Dion, GlobalData's Analyst covering healthcare industry dynamics, states that Eli Lilly and AZ have seen profits fall in the CNS therapeutics market since 2010, with the latter losing the greatest share over the past three years. He comments: "AZ's CNS segment has been bleeding sales as a result of the company losing its patent on Seroquel (quetiapine fumarate), a treatment for bipolar disorder, which led to the entry of cheaper generic alternatives from Teva and Sandoz. We estimate AZ's share to have been around 9% in 2010, which has now fallen to only 3% in 2013. "Eli Lilly's market share declined from 14.3 percent in 2010 to 11.2 percent in 2013, primarily thanks to decreasing sales of Zyprexa (olanzapine), the company's dopamine antagonist used to treat schizophrenia and bipolar disorder. Zyprexa sales have plummeted from over $5 billion to $1.2 billion over the same period, as a result of the drug losing its US patent exclusivity in 2011." The analyst adds that while Otsuka's anti-psychotic drug Abilify (aripiprazole), which the company co-markets with Bristol-Myers Squibb, was the sales leader in the CNS arena with $9.5 billion in 2013, the drug faces a less positive future. Mr Dion explains, "Otsuka benefited from higher annual sales across most major markets in 2013 due to reimbursement and label expansions. In the US and Europe, prescriptions increased for adjunctive therapy in major depressive disorder and manic episodes of bipolar disorder, while there were rising sales in China, where the drug was included in the national medical insurance system. "However, Abilify's upcoming US patent expiration in 2015 means the drug will lose a massive $6.2 billion by 2019 as the result of generic competition, making it the biggest victim of the pharmaceutical industry's current patent cliff." ]]> <![CDATA[Zydus Cadila launches biosimilar of Humira]]> https://biospectrumindia.com/news/95/3961/zydus-cadila-launches-biosimilar-of-humira.html https://biospectrumindia.com/news/95/3961/zydus-cadila-launches-biosimilar-of-humira.html Thu, 11 Dec 2014 14:21:16 +0530 Zydus Cadila has launched biosimilar of Adalimumab, used for the treatment of auto immune disorders. The drug will be available, at a price much lower than the innovator drug, Humira (Adalimumab) by AbbVie. The biosimilar has been approved by the Drug Controller General of India and will be marketed under the brand name 'Exemptia'. The company has got approval for the product for four areas at present, rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis and ankylosing spondylitis. "The cost of the innovator product by AbbVie is $1,000 per vial. Our Exemptia will be available at one-fifth of its cost in India. It is the first biosimilar of Adalimumab. This therapy will offer a new lease of life to millions in India who did not have access to it so far. We are happy to offer them hope, freedom from pain and better quality of life through Exemptia," said Mr Sharvil P Patel , deputy managing director, Zydus Cadila in a statement. ]]> <![CDATA[HIV patients protest against misuse of IP]]> https://biospectrumindia.com/news/95/3902/hiv-patients-protest-against-misuse-of-ip.html https://biospectrumindia.com/news/95/3902/hiv-patients-protest-against-misuse-of-ip.html Wed, 10 Dec 2014 15:59:01 +0530 The rally is concerned with the warning of harmful intellectual property (IP) provisions - put forth by Japan - severely restricting access to affordable medicines for people in developing countries. Started in May 2013, the RCEP is being negotiated between the 10 ASEAN (Association of Southeast Asian Nations) countries and Australia, China, India, Japan, New Zealand and South Korea. Several of the countries negotiating the RCEP are currently also negotiating the Trans-Pacific Partnership (TPP) agreement with the US; leaked drafts of the IP chapter show that the US is pushing for harmful provisions that go beyond WTO trade rules, which are aimed at restricting the ability of governments to regulate in the interest of the public health and delay the availability of low-cost generic versions of medicines. "As countries are putting forth their own proposals for intellectual property chapter in the RCEP, we are worried that US-style IP provisions have been tabled that would roll back public health safeguards enshrined in international law and in India's patent law," explained Mr Anand Grover, director, Lawyers Collective. Japan a key participant in the TPP agreement negotiations is now closely allying with the US in pushing 'extremely stringent IP standards' that undermine and delay access to affordable generic medicines. In the RCEP negotiations, Japan is once again playing a leading role in pushing stringent standards for IP that will undermine and delay access to affordable generic medicines. The leaked text of a proposal put forth by the government of Japan to the Working Group on IP - called the Elements Paper - includes harmful intellectual property provisions such as patent term extensions, data exclusivity and lowering of the patentability criteria, which serve to extend monopoly protection beyond what is required by international agreements and to create new kinds of monopolies, even after patent-based monopolies have expired or where they never existed. "The right to life and health of people in developing countries is at stake in this deal. We want public assurances from the new Indian Prime Minister, Mr Narendra Modi, that any intellectual property provisions that would restrict generic competition and access to medicines will be taken off the table by India," said Mr Loon Gangte, International Treatment Preparedness Coalition (ITPC) - South Asia. "We will continue to fight until these damaging provisions are officially and unequivocally out of the agreement." The RCEP could end up restricting access to life-saving medicines for millions in developing countries by targeting generic competition in India. Unless damaging IP provisions are removed by countries like India before negotiations are finalized, the RCEP agreement - like the TPP - is on track to become one of the most harmful free trade agreements ever for access to medicines in developing countries. "We are urging Ms Nirmala Sitharaman, the Indian Commerce Minister, and India's negotiators to stand strong against Japan's demands on the sensitive issue of intellectual property in the ongoing RCEP negotiations," said Mr Vikas Ahuja of the Delhi Network of Positive People (DNP+). "In 2011, protests by networks of people living with HIV resulted in the European Commission withdrawing and India rejecting some of the most harmful IP provisions in the EU India FTA negotiations, and we will ensure our voices are heard this time too." "India's production of affordable medicines is a vital life-line for MSF's medical humanitarian operations and millions of people accessing treatment in developing countries. MSF alone purchases more than 80 percent of the HIV medicines used in its operations around the world from producers in India. Any inclusion of harmful IP provisions in trade agreements with India would threaten India's role as the pharmacy for developing countries," said Ms Leena Menghaney, regional head - South Asia, MSF Access Campaign. ]]> <![CDATA[Cadila recalls its drug in the US]]> https://biospectrumindia.com/news/95/5235/cadila-recalls-its-drug-in-the-us.html https://biospectrumindia.com/news/95/5235/cadila-recalls-its-drug-in-the-us.html Wed, 10 Dec 2014 11:27:07 +0530 Cadila Healthcare has decided to recall its 15,144 bottles of its anti-hypertension drug, Amlodipine Besylate tablets in the US market. As per reports, Zydus Pharmaceuticals USA, the US-based arm of the company, is recalling the drug due to "discoloration". The withdrawal is classified as a Class-III which FDA defined as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. ]]> <![CDATA[CCI approves Ranbaxy acquisition by Sun ]]> https://biospectrumindia.com/news/95/3889/cci-approves-ranbaxy-acquisition-by-sun-.html https://biospectrumindia.com/news/95/3889/cci-approves-ranbaxy-acquisition-by-sun-.html Tue, 09 Dec 2014 14:19:29 +0530 Sun Pharma and Ranbaxy had filed the notice with the CCI on 6th May 2014 and sought its approval with respect to the deal. Over the past few months, the CCI has sought information and detailed clarifications for the purposes of making its assessment. One of the preconditions of the order is that parties procure the divestment of seven products. These products constitute less than 1 percent of the combined entity's revenues in India. Mr Dilip Shanghvi, MD, Sun Pharma, said, "The order of the CCI approving the deal is an important milestone for the transaction. It revalidates our view that the Sun Pharma and Ranbaxy businesses complement each other with limited product overlap, and will offer a comprehensive product basket to enable future growth. We are pleased with the open and transparent manner in which the matter has progressed." Mr Arun Sawhney, CEO and MD, Ranbaxy, said, "The approval by CCI is a significant step forward. We are confident that post closure, the combined entity will enable sustainable long term growth and deliver immense value for all stakeholders." ]]> <![CDATA[Merial acquires Merck's manufacturing facility]]> https://biospectrumindia.com/news/95/1100/merial-acquires-mercks-manufacturing-facility.html https://biospectrumindia.com/news/95/1100/merial-acquires-mercks-manufacturing-facility.html Mon, 08 Dec 2014 15:51:11 +0530 As part of the agreement, Merial will retain the approximately 200 Merck Barceloneta employees, currently employed at this formulation and packaging site. The proposed transaction requires approval from the United States Federal Trade Commission. If approved, the acquisition will allow Merial to expand its global manufacturing operations and make use of the site's expertise in chewables' manufacturing technology. "The Barceloneta manufacturing operation aligns well with Sanofi and Merial's global business and manufacturing strategies," said Merial's CEO and Sanofi's EVP Mr Carsten Hellmann. "This addition to Merial's global manufacturing network, which spans nine countries, enables Merial to further extend its global production capabilities to deliver high-quality and innovative medicines that enhance the health and well-being of animals. We look forward to assuming responsibility for this global production site and welcoming its experienced employees to Merial." The formulation and packaging operations of the site were put up for sale by Merck. The Barceloneta production facility has been involved in and will maintain responsibility for manufacturing and packaging Merial's industry-leading Heartgard and Heartgard Plus products. ]]> <![CDATA[Monsanto felicitated for employing differently-abled people]]> https://biospectrumindia.com/news/95/5480/monsanto-felicitated-for-employing-differently-abled-people.html https://biospectrumindia.com/news/95/5480/monsanto-felicitated-for-employing-differently-abled-people.html Mon, 08 Dec 2014 15:28:27 +0530 This is the second year in a row Monsanto has received this award. Every year the Software Technology Parks of India (STPI) and the Government of Karnataka come together to recognize IT/ITES companies under various categories of excellence as a part of their coveted 'IT Export Awards'. The awards have been in existence for the past 15 years to promote growth and desirable business/people processes in this fastest growing industry of the country. The Bangalore-based Shared Services Centre (SSC) of Monsanto started operations in 2005 and has grown from a 7-member team to more than 100 members, providing services across ~50 countries where Monsanto has operations. ]]> <![CDATA[Roche acquires Ariosa diagnostics]]> https://biospectrumindia.com/news/95/3475/roche-acquires-ariosa-diagnostics.html https://biospectrumindia.com/news/95/3475/roche-acquires-ariosa-diagnostics.html Mon, 08 Dec 2014 13:35:21 +0530 Roche has announced the acquisition of Ariosa Diagnostics, a molecular diagnostics testing service provider that provides a highly targeted and accurate non-invasive prenatal testing (NIPT) service through their CLIA laboratory using cell-free DNA (cfDNA) technology. Ariosa's proprietary Harmony Prenatal Test has been validated to CLIA requirements by a robust clinical data set and supported by clinical studies in more than 22,000 women of all ages and risk categories. "The acquisition of Ariosa is another example of Roche's commitment to advanced molecular diagnostics. Circulating cfDNA has the promise of providing early diagnostic information through a simple blood test in many important segments including pregnancy, cancer and transplantation, aligning with our strategy in personalised healthcare and commitment to setting new standards of care," said Mr Roland Diggelmann, COO, Roche Diagnostics Division. "We are thrilled to join forces with Roche to continue in our commitment to bringing forward high quality and affordable genetic testing that positively impacts the medical care of patients around the world," said Mr Ken Song MD, chief executive officer, Ariosa. The closing of the transaction is expected to take place in December, 2014. ]]> <![CDATA[Scientists be allowed to work to reduce agri input cost]]> https://biospectrumindia.com/news/95/5579/scientists-be-allowed-to-work-to-reduce-agri-input-cost.html https://biospectrumindia.com/news/95/5579/scientists-be-allowed-to-work-to-reduce-agri-input-cost.html Sat, 06 Dec 2014 20:19:00 +0530 Famers are facing serious trouble over rising input costs of agriculture and all scientists are of the opinion that it should be reduced. It could be reduced with the help of indigenous science. But for that scientists should be allowed to work, to conduct free trials, according to Dr CD Mayee, chairman, Advisory Council- Agrovision. He was giving his concluding remarks in an expert panel discussion on 'Modern Tools for Crop Productivity Improvement and Environmental Concerns' organised as a part of the 6th Agrovision that is going on in Nagpur. In his opening remarks, mr itin Gadkari, chief patron, Agrovision; Minister of Road Transport and Highways; Shipping, stressed the need for looking into how the farm production can be increased using biotechnology. If the oilseeds production is increased by using genetic science it would save large amount of foreign currency, he added. Earlier in his presentation, Dr Mayee said 65 percent of the Indian agriculture is rainfed. He said Indian scientists have potential of solving agriculture related problems. He quoted an example of how a scientist was trying hard to get permissions for trials of GM seeds. Can guidelines be formed for environmental and health tests, he asked. Dr Swapan Datta, deputy director general (Seeds), ICAR, said it was a wrong notion that GM crop is narrowing down biodiversity. It is, in fact enriching biodiversity. He also emphasized on investing a lot in genetic diversity and suggested that there should be clear vision on policy. Agriculture has to go to next phase it could not remain in nostalgia, he added. Similar feelings were expressed by Dr Manvendra Kachore, head of Biotechnology and Biochemistry, Dr Babasaheb Ambedkar Marathwada University, when he said farming cannot remain as lifestyle living. Today or tomorrow it has to become a profession like a cobblers have turned into. He said the opponents of GM technology are pro-active while proponents are on defensive. When GM technology is being used in other sectors like energy, medicine and healthcare why was it being opposed only in agriculture, he asked. Dr Krishan Beer Chaudhary, Bharatiya Krishak Samaj, Mr Ashwani Mahajan, Swadeshi Jagran Manch, and Mr Prabhakar Kelkar, secretary, Bhartiya Kisan Sangh, opposed to the GM technology. Dr Chaudhary said studies on toxicology of GM crop were being done. Giving example of India's export of Basmati rice to Russia, he said Russia asked us if the rice variety was GM and India had to give certify that it was not. In international exports such questions will be asked and answers will have to be given. Do we wish to hand over our food security to only 5 to 6 multi-national companies under the IPR, he asked and said we want technology, but we don't want to compromise, we could not surrender our seeds. Mr Mahajan said 91 percent of GM products are produced only in four countries and hence it was wrong to say that the whole world is using them then why not India should use it. He said he has not come across a single study that said that GM crops has more productivity. He warned that the companies wanted to do field trials because the next steps was commercial trials. Who has seen the long term impact, he asked. Mr Kelkar regretted that now the scientific discoveries were being done for companies' benefits instead of for the people's development. He pointed out that Georgia state in US has also banned GM. He said in fact there was need for doing something for 70 percent farmers who were doing dry farming. Mr Rajendra Barwale, managing director, MAHYCO, said if companies start exploiting farmers as alleged, they would not be able to do long term business. He said farmers want to buy seeds which would give him more yield. Technology has power and science and technology could solve all problems the country was facing. Prof. C Kameswara Rao, Foundation for Biotechnology Awareness and Education (FABE), expressed confidence that the country's regulatory system was robust and was equal to regulatory system in the world. He said if field trials were stopped then the whole process was stopped in the beginning itself. Listen to scientists and believe in them they have integrity, he said. Dr KR Kranti, director, Central Cotton Institute of Cotton Research, said that we must address every concern, but let the science be not stopped. Experiments and field trials were needed, he said and added we must remember that no country has progressed without science. Mr Narayanan Suresh, group editor-BioSpectrum (India & Asia), who moderated the discussion, suggested in his opening remarks to create a separate authority for field trials. Dr KC Bansal, director, National Bureau of Plant Genetic Resources, Dr IS Dua, former chairman, Department of Botany, Panjab University, Chandigarh and ED, Society for Promotion of Science and Technology in India, Dr Arvind Kapur, CEO, Rasi Seeds (P), Dr B Venkateswarlu, vice-chancellor, Vasantrao Naik Marathwada Krishi Vidapeeth, Dr B Dinesh Kumar of National Institute of Nutrition (ICMR) also spoke. Mr Ravi Boratkar, organising secretary, Agrovision, welcomed the experts. ]]> <![CDATA[A new Vaccine offers hope for breast cancer]]> https://biospectrumindia.com/news/95/4404/a-new-vaccine-offers-hope-for-breast-cancer.html https://biospectrumindia.com/news/95/4404/a-new-vaccine-offers-hope-for-breast-cancer.html Sat, 06 Dec 2014 10:36:00 +0530 A breast cancer vaccine developed at Washington University School of Medicine in St Louis has shown positive results in patients with metastatic breast cancer in Phase I clinical trial. The vaccine works to prime a type of white blood cell in the body's adaptive immune system, and seek out and destroy the cells with mammaglobin-A. a protein found almost exclusively in breast tissue. In the smaller proportion of breast cancer patients whose tumors do not produce mammaglobin-A, this vaccine would not be effective. In the new study, 14 patients with metastatic breast cancer that expressed mammaglobin-A were vaccinated. Of the 14 patients who received the vaccine, about half showed no progression of their cancer one year after receiving the vaccine. In a similar control group of 12 patients who were not vaccinated, about one-fifth showed no cancer progression at the one-year follow-up. Based on results of this study, the researchers are planning a larger clinical trial to test the vaccine in newly diagnosed breast cancer patients, who, in theory, should have more robust immune systems than patients who already have undergone extensive cancer therapy. "If we give the vaccine to patients at the beginning of treatment, the immune systems should not be compromised like in patients with metastatic disease. We also will be able to do more informative immune monitoring than we did in this preliminary trial. Now that we have good evidence that the vaccine is safe, we think testing it in newly diagnosed patients will give us a better idea of the effectiveness of the therapy,"said breast cancer surgeon and senior author of the study Dr William E Gillanders. ]]> <![CDATA[World's first artificial enzymes created using synthetic biology]]> https://biospectrumindia.com/news/95/4899/worlds-first-artificial-enzymes-created-using-synthetic-biology.html https://biospectrumindia.com/news/95/4899/worlds-first-artificial-enzymes-created-using-synthetic-biology.html Thu, 04 Dec 2014 16:49:31 +0530 A team of researchers have created the world's first enzymes made from artificial genetic material. The research is published in the journal Nature and promises to offer new insights into the origins of life, as well as providing a potential starting point for an entirely new generation of drugs and diagnostics. In addition, the authors speculate that the study increases the range of planets that could potentially host life. The findings build on previous work in which the scientists, from the MRC Laboratory of Molecular Biology in Cambridge and the University of Cambridge, created synthetic molecules called 'XNAs'. These are entirely artificial genetic systems that can store and pass on genetic information in a manner similar to DNA. The synthetic enzymes, which are made from molecules that do not occur anywhere in nature, are capable of triggering chemical reactions in the lab. All life on earth depends on the chemical transformations that enable cellular function and the performance of basic tasks, from digesting food to making DNA. These are powered by naturally-occurring enzymes which operate as catalysts, kick-starting the process and enabling such reactions to happen at the necessary rate. For the first time, however, the research shows that these natural biomolecules may not be the only option, and that artificial enzymes could also be used to power the reactions that enable life to occur. Using these XNAs as building blocks, the new research involved the creation of so-called 'XNAzymes'. Like naturally occurring enzymes, these are capable of powering simple biochemical reactions. Dr Alex Taylor, a post-doctoral researcher at St John's College, University of Cambridge, who is based at the MRC Laboratory and was the study's lead author, said: "The chemical building blocks that we used in this study are not naturally-occurring on Earth, and must be synthesized in the lab. This research shows us that our assumptions about what is required for biological processes - the 'secret of life' - may need some further revision. The results imply that our chemistry, of DNA, RNA and proteins, may not be special and that there may be a vast range of alternative chemistries that could make life possible." Our cells contains thousands of different enzymes, many of which are proteins. In addition, however, nucleic acids - DNA and its close chemical cousin, RNA - can also form enzymes. The ribosome, the molecular machine which manufactures proteins within all cells, is an RNA enzyme. Life itself is widely thought to have begun with the emergence of a self-copying RNA enzyme. Dr Philipp Holliger, from the MRC Laboratory of Molecular Biology, said, "Until recently it was thought that DNA and RNA were the only molecules that could store genetic information and, together with proteins, the only biomolecules able to form enzymes." He stated, "Our work suggests that, in principle, there are a number of possible alternatives to nature's molecules that will support the catalytic processes required for life. Life's 'choice' of RNA and DNA may just be an accident of prehistoric chemistry." "The creation of synthetic DNA, and now enzymes, from building blocks that don't exist in nature also raises the possibility that if there is life on other planets it may have sprung up from an entirely different set of molecules, and widens the possible number of planets that might be able to host life," he further added. The group's previous study, carried out in 2012, showed that six alternative molecules, called XNAs, could store genetic information and evolve through natural selection. Expanding on that principle, the new research identified, for the first time, four different types of synthetic catalyst formed from these entirely unnatural building blocks. These XNAzymes are capable of catalyzing simple reactions, like cutting and joining strands of RNA in a test tube. One of the XNAzymes can even join strands together, which represents one of the first steps towards creating a living system. Because their XNAzymes are much more stable than naturally occurring enzymes, the scientists believe that they could be particularly useful in developing new therapies for a range of diseases, including cancers and viral infections, which exploit the body's natural processes. Dr Holliger added, "Our XNAs are chemically extremely robust and, because they do not occur in nature, they are not recognized by the body's natural degrading enzymes. This might make them an attractive candidate for long-lasting treatments that can disrupt disease-related RNAs." Prof. Patrick Maxwell, chair of the MRC's Molecular and Cellular Medicine Board and Regius Professor of Physic at the University of Cambridge, said, "Synthetic biology is delivering some truly amazing advances that promise to change the way we understand and treat disease. The UK excels in this field, and this latest advance offers the tantalizing prospect of using designer biological parts as a starting point for an entirely new class of therapies and diagnostic tools that are more effective and have a longer shelf-life." Funders of the research included the MRC, European Science Foundation and the Biotechnology and Biological Sciences Research Council. ]]> <![CDATA[Bayer steps up focus on R&D]]> https://biospectrumindia.com/news/95/4646/bayer-steps-up-focus-on-rd.html https://biospectrumindia.com/news/95/4646/bayer-steps-up-focus-on-rd.html Thu, 04 Dec 2014 10:13:00 +0530 "Overall, we expect the R&D-to-sales ratio to increase in the coming years," said Bayer's management board chairman Dr Marijn Dekkers at Bayer's Perspective on Innovation 2014 press forum in Leverkusen, Germany. The research and development budget in the life science businesses this year amounts to â‚¬3.2 billion. Of this amount, Bayer healthcare accounts for 70 percent and Bayer cropscience for 30 percent. Dr Dekkers said that as a world-class lifescience company, Bayer will continue to target attractive markets with high growth rates, and in following this course, it has very good prospects for the future. He explained that the company has more than 13,000 employees in research and development, 61 percent of them in healthcare and 39 percent in cropscience, and that it has made major progress in both businesses. In the pharmaceuticals segment, Bayer has successfully completed 25 Phase III clinical studies since 2010, and at cropscience introduced 30 new active ingredients to the market between 2000 and 2013. Last year alone, Bayer applied for 500 patents in the life sciences. Dr Dekkers remarked that developing new products is critical to the success of the life science businesses. The seed business currently is ranked 7th globally, and is to be further expanded in the future. "Our business models, whether in healthcare or cropscience, have many similarities," Dr Dekkers said. ]]> <![CDATA[James Watson 'Father of DNA' auctioning off his Nobel Prize]]> https://biospectrumindia.com/news/95/6050/james-watson-father-of-dna-auctioning-off-his-nobel-prize.html https://biospectrumindia.com/news/95/6050/james-watson-father-of-dna-auctioning-off-his-nobel-prize.html Wed, 03 Dec 2014 17:33:00 +0530 James Watson, considered the 'Father of DNA' is selling his Nobel Prize. In 1962 he received the Nobel Prize for discovering the structure of DNA along with Francis Crick. Mr. Watson has kept a reserve price of $2.5 million for the medal at the auction on Thursday. According to various media reports, Mr Watson was widely shunned for his racist comments in an interview with the Sunday Times in 2007, his public lectures dried up and he was sacked from the boards of companies. Mr Watson will use the money from the auction to supplement his academic income, donate to academic institutions and charity, and perhaps buy a David Hockney artwork. ]]> <![CDATA[Aurobindo Pharma to acquire Natrol for $132.5 Mn]]> https://biospectrumindia.com/news/95/6049/aurobindo-pharma-to-acquire-natrol-for-132-5-mn.html https://biospectrumindia.com/news/95/6049/aurobindo-pharma-to-acquire-natrol-for-132-5-mn.html Wed, 03 Dec 2014 14:12:52 +0530 The bid is valued at US$132.5 million. Natrol manufactures and sells nutritional supplements in the US and other international market. This acquisition is subject to final approval by the US Court and other statutory approvals as may be required, including any termination of the waiting period or approval under the HSR Act, and closing conditions as per the Asset Purchase Agreement. Barclays acted as the sole financial advisor, and Sullivan & Cromwell LLP acted as the legal counsel to Aurobindo USA. This announcement does not constitute a recommendation to the shareholders or potential investors. ]]> <![CDATA[Sequel Logistics wins SME Business Excellence Award 2014]]> https://biospectrumindia.com/news/95/5746/sequel-logistics-wins-sme-business-excellence-award-2014.html https://biospectrumindia.com/news/95/5746/sequel-logistics-wins-sme-business-excellence-award-2014.html Wed, 03 Dec 2014 12:57:49 +0530 SEQUEL LOGISTICS was honoured as the award winner at the SME Business Excellence Awards 2014 in the mid corporate segment for excellence in the tansportation and logistics sector. The Times Group, Federal Bank, and Dun and Bradstreet has joined hands to launch the "SME Business Excellence Awards 2014" to recognise India's leading SMEs. The chief guest Mr Jayant Sinha, Minister of State, Ministry of Finance, Government of India felicitated the award winners. Speaking on the occasion, Mr Sharad Jobanputra, chairman and managing director, Sequel Logistics said, 'It is honour to receive this prestigious award. Sequel has relentlessly pursued excellence for more than a decade to win the trust of our customers.' The minister also released D&B's premier publication, 'Leading SMEs of India 2014' along with Mr Kaushal Sampat, president and MD-India, Dun & Bradstreet, Mr Abraham Chacko, executive director, Federal Bank and Mr Ravindra Nath, chairman and MD, National Small Industries Corporation. ]]> <![CDATA[Quintiles offers Marketed Product Maintenance (MPM)]]> https://biospectrumindia.com/news/95/3979/quintiles-offers-marketed-product-maintenance-mpm.html https://biospectrumindia.com/news/95/3979/quintiles-offers-marketed-product-maintenance-mpm.html Tue, 02 Dec 2014 13:13:19 +0530 Quintiles has announced a new offering, Marketed Product Maintenance (MPM), that will provide biopharmaceutical companies with greater data-driven insights into the benefit-risk profiles of their products. These enhanced insights will enable customers to identify potential product risks, fulfill increasingly complicated regulatory requirements and help them make better decisions about their marketed products. By using technology and subject matter expertise to connect the post-approval requirements and license maintenance processes more effectively and efficiently, biopharmaceutical companies can generate greater return on investment from their portfolio of established products by redeploying resources on prioritized, growth-oriented products. "Within most biopharmaceutical companies, regulatory, safety maintenance and benefit-risk management functions could benefit from more interdependence. Meanwhile, these companies are facing more complex safety and regulatory requirements, along with increasing budget constraints, making it increasingly difficult to achieve their regulatory obligations while improving the total cost of managing their established products. Integrating these functions through our innovative MPM solution will assist customers in maximizing the commercial value of their established products," said Ms Paula Brown Stafford, president of clinical development at Quintiles. These services will be delivered globally as an integrated and efficient turnkey solution, leveraging the company's extensive safety, regulatory, benefit-risk management research experience. ]]> <![CDATA[Vyome Biosciences announces new management team]]> https://biospectrumindia.com/news/95/4754/vyome-biosciences-announces-new-management-team.html https://biospectrumindia.com/news/95/4754/vyome-biosciences-announces-new-management-team.html Tue, 02 Dec 2014 13:11:52 +0530 Vyome Biosciences has announced that MD and CEO of Manipal Education and Medical Group, Dr Ranjan Pai, has joined its board of directors. Dr Pai's venture firm Aarin Capital is an investor in Vyome. The company also appointed Dr Richard Buchta, formerly Head of GlaxoSmithKline's dermatology unit Stiefel Laboratories in Australia, as senior vice-president, R&D. "Dr Pai is recognised as one of India's top corporate leaders. As Vyome scales operations and prepares to enter the commercialisation phase, his addition adds tremendous strategic experience to the Board. The globalisation and expansion of the Manipal Education and Medical Group through his strategic vision is an experience that will serve Vyome in good stead as the company looks abroad for development and licensing opportunities," said Mr N Venkat, co-founder and CEO, Vyome Biosciences. "Vyome is a proving to be a serious innovative play in the lifesciences industry, and holds a special place in Aarin's portfolio. I am personally looking forward to work more closely with the rest of the board, Shiladitya, Venkat and the rest of their team as the company breaks new ground in markets both in India and abroad," said Dr Pai. "Dr Buchta brings rich specialist experience with numerous patent applications and multiple IND filings in dermatology to Vyome's senior management team, and this will multiply the Company's capabilities as we enter the regulatory filing stages for our pharmaceutical programs. Vyome is geared up to press ahead on," added Mr Venkat. ]]> <![CDATA[FIPB approves Sun Pharma issuing shares to non-resident investors]]> https://biospectrumindia.com/news/95/4304/fipb-approves-sun-pharma-issuing-shares-to-non-resident-investors.html https://biospectrumindia.com/news/95/4304/fipb-approves-sun-pharma-issuing-shares-to-non-resident-investors.html Tue, 02 Dec 2014 12:38:18 +0530 With reference to earlier announcement dated November 24, 2014 regarding updates on Scheme of Arrangement, Sun Pharmaceutical has informed further to Bombay Stock Exchange (BSE) that Foreign Investment Promotion Board (FIPB) has approved its proposal for issuing its equity shares to the non-resident investors of Ranbaxy Laboratories pursuant to the merger of Ranbaxy Laboratories into Sun Pharmaceutical Industries through the scheme of arrangement between Ranbaxy Laboratories and Sun Pharmaceutical Industries. ]]> <![CDATA[Ranbaxy launches India's first biosimilar of Infliximab ]]> https://biospectrumindia.com/news/95/5300/ranbaxy-launches-indias-first-biosimilar-of-infliximab-.html https://biospectrumindia.com/news/95/5300/ranbaxy-launches-indias-first-biosimilar-of-infliximab-.html Tue, 02 Dec 2014 12:04:51 +0530 Infimab will be manufactured by Reliance Life Sciences at a facility in Mumbai. The product was launched at the Indian Rheumatology Association Conference (IRACON), in the presence of thousands of rheumatologists and doctors from around the country. Infimab is being introduced to the Indian market through a licensing partnership with EPIRUS Biopharmaceuticals, a US and Swiss-based focused on the global development and commercialization of biosimilar monoclonal antibodies. The innovator reference product is currently marketed for the treatment of inflammatory diseases including rheumatoid arthritis (RA), Crohn's disease, ankylosing spondylitis, ulcerative colitis, psoriatic arthritis and psoriasis. Infimab marks Ranbaxy's entry into mAb (Monoclonal Antibodies) biologics, and will help the company provide greater access to quality biologic medicines in management of conditions like rheumatoid arthritis. Mr Rajeev Sibal, VP and country head-India region, Ranbaxy, said, ".... The product has been developed as per global standards and delivers a similar clinical outcome to the innovator. It will be available in India at a very significant discount as compared to that of the innovator drug...." Rheumatoid arthritis is one of the most common chronic inflammatory diseases that cause disability. The literature estimates a prevalence of 0.5% to 0.75% in India. To manage the disease, Indian rheumatologists are using Infliximab to treat only a select set of patients because it is very expensive. Dr Arvind Chopra, consultant rheumatologist, Pune, who was also the principal investigator of clinical trial conducted in India stated, "....The drug will not only be able to stop progression of rheumatoid arthritis but effectively control several of its complications that include bone damage, deformities and osteoporosis. Infimab also has an excellent treatment potential to treat other crippling painful arthritis like ankylosing spondylitis and psoriatic arthritis." ]]> <![CDATA[Legal battle: Natco pays Rs 15 crore to SMS Pharma]]> https://biospectrumindia.com/news/95/5794/legal-battle-natco-pays-rs-15-crore-to-sms-pharma.html https://biospectrumindia.com/news/95/5794/legal-battle-natco-pays-rs-15-crore-to-sms-pharma.html Tue, 02 Dec 2014 11:42:57 +0530 Hyderabad-based API manufacturer, SMS Pharmaceuticals, has informed Bombay Stock Exchange (BSE) that the legal disputes between the company and Natco Pharma have been amicably settled. Out of the settlement, SMS Pharma has received a sum of Rs 15.07 crore from Natco apart from the balance principal amount receivable from the respective courts. ]]> <![CDATA[Key vulnerable populations to HIV must be reached urgently: WHO]]> https://biospectrumindia.com/news/95/8407/key-vulnerable-populations-to-hiv-must-be-reached-urgently-who.html https://biospectrumindia.com/news/95/8407/key-vulnerable-populations-to-hiv-must-be-reached-urgently-who.html Mon, 01 Dec 2014 15:14:34 +0530 This implies that the communities most vulnerable to HIV are equal partners with governments in responding to the epidemic. Nearly five million people were living with HIV in the Asia-Pacific region in 2013, about one-sixth of the global burden. The regional HIV burden is the second highest after Sub-Saharan Africa with an estimated 350,000 new HIV infections in 2013. "Although HIV numbers have fallen in some countries, the epidemic is rising quickly in many others and is concentrated in key populations," said Dr Shin Young-soo, WHO regional director, Western Pacific. "Less than half of all HIV positive people across Asia and the Pacific are aware of their status and less than half of those who need anti-retroviral drugs are taking them. Closing the HIV testing and treatment gaps can improve support and access to lifesaving medicine for those in need. Otherwise, we may not aspire to the global goal of ending AIDS by 2030." "We've seen that effective partnerships between health systems and key populations lead to greater access to HIV testing and lifesaving treatment, increased domestic resources for HIV/AIDS programmes and reduced stigma and discrimination," said Dr Poonam Khetrapal Singh, WHO regional director for Southeast Asia. She further added, "A collaborative approach results in better health outcomes. A prime example is WHO's consolidated guidelines on HIV prevention, diagnosis, treatment and care for key populations, where significant input was provided by the key populations themselves." The guidelines, launched at the 20th International AIDS Conference in Melbourne in 2014, show the linkages between key populations, thereby helping governments and health-care providers strategize HIV programs. Roll out of the guidelines across the Asia-Pacific region was recently discussed at a bi-regional meeting of government representatives, WHO, UNAIDS, and community partners in Manila. "HIV is devastating our communities, and the statistics are frightening" explained Mr Midnight Poonkasetwattana, executive director, Asia Pacific Coalition on Male Sexual Health (APCOM), which advocates greater resources, research and a rights-based approach to HIV and other issues affecting men who have sex with men (MSM). "Nine out of ten new HIV cases in Manila involve MSM. One out of three MSM in Bangkok is HIV positive. Most of China's new HIV cases are MSM. Young people are especially at risk. This scenario is repeated elsewhere. But even now, we don't see adequate investment in most countries." MSM and other key populations continue to be persecuted and stigmatized, driving the epidemic underground. "APCOM is pleased to collaborate with WHO in advocating for the consolidated guidelines to be adopted and implemented, but we hope that governments finally wake up to the crisis and address reality," Mr Poonkasetwattana added. WHO has long called for greater national, regional and global commitment to ensure adequate funding and resources to address HIV in key populations. Renewed focus and investment in the HIV response needs to be articulated in the post-2015 health and development agenda. "Ultimately, we can only reach the fast-track targets by 2020 in Asia and the Pacific if 90% of key populations on treatment have suppressed viral loads," said Dr Ying-Ru Lo, coordinator, HIV, Hepatitis and Sexually Transmitted Infections, WHO regional office, Western Pacific. "Currently, we are far from reaching those targets. HIV testing is the entry point for treatment, but only around a third of key populations know their HIV status." "Reaching fast-track targets would avert almost 5 million new HIV infections and 3.5 million AIDS-related deaths in Asia and the Pacific between 2015 and 20130," said Dr Razia Narayan Pendse, advisor, HIV/STIs, WHO regional office, Southeast Asia. "WHO is working to close the gaps and improve the continuum of HIV prevention, treatment and care. And we are doing so hand-in-hand with the key populations at the heart of the epidemic, to help safeguard the health and well-being of millions of people now and in the future." ]]> <![CDATA[Cipla, Strides collaborate with MMV]]> https://biospectrumindia.com/news/95/5725/cipla-strides-collaborate-with-mmv.html https://biospectrumindia.com/news/95/5725/cipla-strides-collaborate-with-mmv.html Mon, 01 Dec 2014 14:41:20 +0530 Medicines for Malaria Venture (MMV) signed collaboration agreements with two Indian pharmaceutical companies, Cipla and Strides Arcolab, for the development of rectal artesunate for pre-referral treatment of children with severe malaria. The collaborations, established under the MMV-led 'Improving Severe Malaria Outcomes' project funded by UNITAID, aim to develop a rectal artesunate product for submission to World Health Organization prequalification. Cipla and Strides will each develop a product building on the clinical studies led by TDR, the Special Program for Research and Training in Tropical Diseases led by the WHO The goal is to achieve WHO-prequalification of a rectal artesunate product by 2016. "This is a significant milestone in our project to improve severe malaria outcomes," said Dr David Reddy, MMV's CEO. "We have agreed a clear pathway with these two manufacturers to bring this product to an internationally acceptable quality standard. This will help make the product available to more patients, buying more time and saving more lives. We look forward to working closely with Cipla and Strides and thank UNITAID for supporting these efforts." Mr Subhanu Saxena, MD and global CEO, Cipla, said "We are happy to join hands with MMV that shares our ongoing commitment to fight against Malaria..... Through this collaboration, we will endeavor to make rectal artesunate accessible to each and every child with severe malaria in a pre-referral setting in malaria-endemic countries." "We are excited to be part of this initiative, as it will expand access to quality, affordable medicines for a wider population and save more lives," said Mr Mohan Kumar, CEO, Strides Arcolab. ]]> <![CDATA[World Aids Day: More than 10 million people on HIV treatment globally]]> https://biospectrumindia.com/news/95/5132/world-aids-day-more-than-10-million-people-on-hiv-treatment-globally.html https://biospectrumindia.com/news/95/5132/world-aids-day-more-than-10-million-people-on-hiv-treatment-globally.html Mon, 01 Dec 2014 12:31:16 +0530 "We now have more than 10 million people on HIV treatment globally. In the WHO Southeast Asia Region, as of 2013, we had around 3.4 million people living with HIV; 1.1 million of them are currently on treatment. In 2004, 83,000 people were on treatment. We have managed to increase the coverage 12-fold in a decade," said Dr Poonam Khetrapal Singh, regional director, WHO Southeast Asia. Concerted responses led by civil society movements, supported by national and international commitments bolstered by scientific research have made this possible. While there is much to cheer about, it is a sobering reality that we still need to reach out to more than 50 percent of people estimated to be living with HIV, who are either not linked to care or not aware of their status. Dr Singh revealed, "The HIV epidemic in our region is concentrated among populations most vulnerable to HIV: men who have sex with men, transgender people, people who inject drugs, sex workers, people in prisons and other closed settings. Although we have been successful in scaling up the health sector response for the vulnerable populations, more needs to be done. Less than 50% of these people know their HIV status." Stigma, discrimination, and restrictive laws continue to be barriers to accessing prevention, care, and treatment services. We are on the right path and science is helping us identify newer, better and more effective interventions for the prevention and management of HIV, mentioned Dr Singh. "This year WHO has launched the updated consolidated guidelines on the use of anti-retroviral drugs for treating and preventing HIV infection and on HIV prevention, diagnosis, treatment and care for key populations. These are guided by human rights principles and call for governments to enforce protective laws to eliminate discrimination and violence faced by key populations." WHO is releasing a new update to recommend anti-retroviral drugs as an emergency prevention intervention following possible HIV exposure for HIV-negative individuals, and to prevent and manage common infections that affect many people living with HIV. ]]> <![CDATA[International Proteomics Conference to be held in IIT-B ]]> https://biospectrumindia.com/news/95/5539/international-proteomics-conference-to-be-held-in-iit-b-.html https://biospectrumindia.com/news/95/5539/international-proteomics-conference-to-be-held-in-iit-b-.html Fri, 28 Nov 2014 18:07:00 +0530 The International Proteomics Conference and 6th Annual Meeting of the Proteomics Society, India (PSI) would be held in Dec 2014 at the Indian Institute of Technology Bombay. The 6-day long congress (6-11 Dec 2014) includes an International Conference, Workshops and Education Day. Dr Sanjeeva Srivastava is an associate professor at IIT Bombay and convener of the conference. Proteomics, the study of the proteome, which is defined as the entire complement of proteins that can be expressed by a cell, tissue, or organism has evolved to become an indispensable resource for Biology and Biomedical research. Proteins being the direct facilitators of numerous biological processes are amongst the most effective and sought after targets for translational research. Their involvement in various cancers and a number of other diseases emphasizes the importance of studying the biological roles of these proteins. The Proteomics Society of India aims to provide a strong platform for association amongst researchers from institutes and research groups in India and internationally, who have been using proteomic technologies in their research efforts to promote and advance their research. Renowned scientists and policy makers from across the globe involved in cutting edge research in proteomics technologies and system biology are expected to address the participants on current research efforts in proteomics and multi-omics technologies. Leading pioneers like Dr Pierre Legrain (HUPO President), Dr Mark Baker(HUPO President-elect), Dr Gilbert Omenn (Ex-US HUPO President), Dr Samir Hanash (Ex- HUPO President), Dr Catherine Costello (Ex-HUPO President), Dr Catherine Fenselau (Ex-President US- HUPO, ASMS), Dr. John Yates, Dr Sudhir Srivastava, Dr Brenda Andrews, Dr Philip Andrew, Dr Chung Ching Ming Maxey, Dr Andrew Link, Dr Robert L Moritz, Dr Juan Calvete are amongst many distinguished scientists who have confirmed their participation for this event. The conference would feature over 70 stimulating talks delivered by notable scientists on various themes like Cancer biomarkers, Biomarkers of biofluids, Mass Spectrometry and Post- translational modifications, New advances in Mass Spectrometry, Interactomics and multiomics analysis, Proteomics and Systems Biology, Mass Spectrometry and Metabolomics, Microbial Proteomics and Human Proteome Project. Interesting panel discussions addressing some key questions in the field of Biomedical and Proteomics would help scientists understand and upgrade the norms of research which would in turn result in shaping and elevating the standards of biosciences research pursued. In addition to this, parallel sessions on Biosimilars and biotherapeutics have been scheduled on 8th Dec 2014. This seminar would witness participation of representatives from the US-FDA and other regulatory authorities, for the first time in India, to provide insights into how the power of proteomics based technology can be harnessed in the Biopharma industry. ]]> <![CDATA[Merck inaugurates its new biomass plant ]]> https://biospectrumindia.com/news/95/4078/merck-inaugurates-its-new-biomass-plant-.html https://biospectrumindia.com/news/95/4078/merck-inaugurates-its-new-biomass-plant-.html Thu, 27 Nov 2014 17:57:33 +0530 German drug giant Merck has commissioned a climate-neutral co-generation plant at its production site in Goa today. The initiative is a part of Merck's company-wide climate protection program. Earlier this year, the drug maker had set up a new co-generation plant at its headquarters in Darmstadt. The plant was inaugurated by Dr Thierry Hulot, executive vice president, head of global manufacturing and supply and member of Merck Pharmaceutical Executive Committee. This co-generation unit, which has a power output of three megawatts is expected to generate electricity and steam for the pharmaceutical and chemical production operations in Goa. The company is mainly recycling shells of cashews and coconuts, two crops that are farmed in the region, to use as biomass. It is estimated that the initiative will reduce carbon dioxide emissions by around 11,500 metrics tons, corresponding to around 85 percent of the site's total CO2 emissions. Speaking at the event, Dr Hulot, said, "Merck's new climate-neutral co-generation plant in Goa has a tremendous power output for our pharmaceutical and chemical production operations. In the manufacturing of our products, we seek to impact the environment as little as possible. As a responsible company, we express our respect to the environment in an industrial plant that provides medicines for millions of patients in India." The biomass plant will ensure that the production site has adequate power supply and will function independent of the public power grid. Merck is a global leader in the lifesciences sector providing innovative and top-quality high-tech products in the pharmaceutical, chemical and biotech sectors. More than 300 employees manufacture vitamin preparations, industrial and laboratory chemicals as well as microbiological products, among other things. Mr Pramod Pimplikar, director, Technical Operations, GMS- Merck Serono, said, "We are extremely excited in being able to make a positive difference to our business, the environment and capacity building efforts. With this Green field site, we aim to reduce CO2 emission by 85 percent and deliver clean, green, efficient, reliable power and steam supply, improving efficiency and contributing to the nation's interest. By 2020, Merck KGaA has committed to reduce its global CO2 emissions by 20 percent and we are happy to be in a position to contribute to those efforts." ]]> <![CDATA[Bionova poised for 300% growth by FY17]]> https://biospectrumindia.com/news/95/4014/bionova-poised-for-300-growth-by-fy17.html https://biospectrumindia.com/news/95/4014/bionova-poised-for-300-growth-by-fy17.html Thu, 27 Nov 2014 16:57:41 +0530 Bangalore-based application research and formulation company, Bionova announced that the company is betting on the rapid development of Indian biopharma industry and foresee 300 percent revenue growth by the end of financial year 2017. The company is planning to launch a range of OTC products (over-the-counter non-prescription) for infant nutrition, child growth, diabetic supplements and wellness. The new range of product line will enable Bionova to develop a competitive stand along the line of present Indian and global players in the market. Commenting on the announcement, Mr Suddhir Jain, MD, Bionova, said, "We are poised to achieve a strong set of numbers during current financial year. The new organization structure will enable us to deliver superior results while our current product range has been performing strongly. Our human wellness focused unique formulations vertical is growing at a rapid pace and will be launching an exciting range of product line over next few months..." Increasing awareness on alternative wellness products, growing confidence in OTC products, and change of prescription drugs to OTC products will drive the pharmaceutical market. The various segments of OTC products such as vitamins and minerals, gastrointestinal, and cough cold and allergy are the major reasons for the popularity of the OTC product market. Growing number of self-treatment patient base and their confidence in the OTC drugs is helping the Indian market to grow. Bionova has invested towards formulation and research activities across it OTC product range to acquire market pie in the branded formulations space. ]]> <![CDATA[BioAsia 2015 to herald 'Opportunities in Transition']]> https://biospectrumindia.com/news/95/3993/bioasia-2015-to-herald-opportunities-in-transition.html https://biospectrumindia.com/news/95/3993/bioasia-2015-to-herald-opportunities-in-transition.html Thu, 27 Nov 2014 14:46:00 +0530 The 12th edition of the annual international lifesciences conference, BioAsia 2015 will unveil 'New Opportunities in Transition' in the field of lifescience and healthcare industry. BioAsia 2015 will be held in Hyderabad from February 2 to 4, 2015. While announcing the launch of BioAsia 2015, Mr Shakthi Nagappan, CEO, BioAsia said, "BioAsia 2015 will be organized with the theme of New Era of lifesciences to symbolise the transitioning phase of opportunities in India and also contribute to the Country's economic revival agenda. The event is designed to offer the right opportunities to catch the right notes and develop strategies to succeed in emerging markets like India." BioAsia has emerged as an unparalleled industry platform with a relevant business outlook to the Lifesciences industry and BioAsia 2015 will unveil positivity, promising extra ordinary growth and an innovation driven bio economy. The current edition BioAsia 2015 will include conferences and expert sessions, CEO conclave and workshops on the topics like 'Drug Discovery and India's Innovation Pipeline', 'Digital Health and Healthcare IT', 'Clinical Research', 'Supply Chain and Logistics', 'Rapid Diagnostics' 'Medical Electronics and Devices', and 'Public Health & Access' along with international tradeshow, networking receptions, BioAsia connect and BioPark visits. BioAsia 2015 is organised by the Federation of Asian Biotech Association [FABA] and the Pharmaceutical Export Promotion Council (Pharmexcil) with the support of State Government and the Government of India. ]]> <![CDATA[DuPont felicitate scientific innovation]]> https://biospectrumindia.com/news/95/3996/dupont-felicitate-scientific-innovation.html https://biospectrumindia.com/news/95/3996/dupont-felicitate-scientific-innovation.html Thu, 27 Nov 2014 13:29:27 +0530 Dr Ravi Maruthachalam, assistant professor at Indian Institute of Science Education and Research - Thiruvananthapuram (IISER-TVM) was awarded with a DuPont 2014 Young Professor (DYP) award. He formally received this recognition from Dr Ranjan Patnaik, director, DuPont Knowledge Center (DKC), Hyderabad, on the occasion of the Science Day celebration at DKC. He is one of the top 10 international young faculty members to be recognized with the award. Dr Ravi Maruthachalam received PhD from Centre for Cellular and Molecular Biology (CCMB) Hyderabad and was a postdoc at Department of Plant Biology, University of California, Davis. He is also a recipient of UC Davis Award of Excellence in Post doctoral research, an early career award from American Society of Plant Biology (ASPB) and currently a Ramalingaswami fellow ( awarded by Department of Biotechnology, Government of India) and Assistant Professor at School of Biology, IISER-Thiruvananthapuram, Kerala, India. The DuPont Young Professor program is designed to help promising young and untenured research faculty memebers working in areas of interest to DuPont. "Young professors award is one of the key DuPont initiatives to encourage academic research that help develop innovations to address the global challenges of food, energy and protection, " said Dr Ranjan Patnaik. He added, "We are delighted to recognize talent in India who have the potential to make path-breaking research contributions." Speaking on the occasion, Dr Maruthachalam said, "I am very excited and honored to be one among the recipients of this prestegious award." Dr Maruthachalam's interests are in the area of agricultural biotechnology, plant biology and reproduction. His group is working on cutting edge technologies to expedite plant breeding. This technology has the potential to dramatically reduce the breeding time and resources required for hybrid seed production. ]]> <![CDATA["Early diagnosis is the key to successful treatment"]]> https://biospectrumindia.com/views/95/6245/early-diagnosis-is-the-key-to-successful-treatment.html https://biospectrumindia.com/views/95/6245/early-diagnosis-is-the-key-to-successful-treatment.html Thu, 27 Nov 2014 10:08:00 +0530 About Author: Dr Siddarth Ramji is is an eminent pediatrician and neonatologist, academic and researcher. He has been on several task forces and committees that have been involved in formulating child health policy in India. He is currently the Executive Editor of "Indian Pediatrics" and has to his credit almost 100 Research publications. ---------------------------------------------------------------------- Pneumonia and diarrhea continue to be important contributors to child mortality in India. According to the Lancet, in 2013 there were 388,000 pneumonia and 206,000 diarrhea deaths in India alone. Preventing pneumonia is, therefore, a key strategy in child mortality reduction endeavors in the country. Prevention of pneumonia can be achieved by multiple interventions, important amongst them being immunization and environmental pollution control. There are a number of vaccines which are available for targeting respiratory infections, some already introduced into the public health system and some awaiting introduction. Early diagnosis of pneumonia is key to successful treatment. The challenge lies in educating families to identify symptoms and seeking health care early, and training primary care health care providers in early detection, treatment and referral. The figures tell the story. Pneumonia and diarrhoea account for nearly 4 out of 10 under-five deaths. There are 35 million episodes of pneumonia each year, of which four million are severe pneumonia. There are 312 million episodes of diarrhoea each year, of which 6.74 million episodes are severe diarrhoea. The Integrated Management of Neonatal and Childhood Illness (IMNCI) which is the Indian adaptation of the WHO-UNICEF generic Integrated Management of Childhood Illness (IMCI) strategy was developed to enable early diagnosis, identify symptoms and seek health care. However, a decade since the introduction of IMNCI into India, the strategy has not evolved beyond the training stage, and the systems changes that were needed have not taken place. To support the public health system to facilitate early pneumonia detection and treatment and empower communities in seeking health care early, the Government of India has recently adopted the Global Action Plan for Pneumonia and Diarrhea. Four States in India Uttar Pradesh, Bihar, Madhya Pradesh and Rajasthan account for more than half of Under-5 Deaths and the India Action Plan for Pneumonia and Diarrhea could help with some critical issues that India currently faces. Transfer of clinical skills for pneumonia identification and treatment, and ensuring their retention and practice at the primary health care level is a daunting task. It is important for the Government to address standards required for pneumonia detection and treatment. Severe pneumonia which needs institutional care is challenged by issues such as access to facilities with adequate infrastructure to treat such children which includes availability of appropriate injectable antibiotics, oxygen delivery systems, and trained health care providers. Besides, one has to reckon with the fact that a large proportion these children are also undernourished which complicates their management and increases the risk of an adverse outcome. Reduction in pneumonia related child death is not as easily amenable to simple interventions as some other diseases. Sufficient robust epidemiological data for the introduction of preventive vaccines, health systems strengthening and active participation of civil society should move in tandem in our efforts to reduce pneumonia related child deaths. As work on these important issues hopefully pick up momentum policy makers also need to take cognizance of the implications of any new intervention and at scale - issues of training, logistics of procurement storage, disposal, and awareness campaigns for health care providers and the public at large. On the other hand, the likelihood of greater and sustained impact is expected with reduction in environment pollution; the task however is very daunting and needs a concerted effort by several agencies and civil society. ]]> <![CDATA[GM Crop field trials not banned: Mr Javadekar]]> https://biospectrumindia.com/news/95/4558/gm-crop-field-trials-not-banned-mr-javadekar.html https://biospectrumindia.com/news/95/4558/gm-crop-field-trials-not-banned-mr-javadekar.html Wed, 26 Nov 2014 17:31:00 +0530 Speaking in the upper house of the Parliament on November 26, 2014, Mr Javadekar mentioned that it is in the national interest that the research in GM crops and confined field trials for bio-safety data be allowed to continue. However, he also talked about taking appropriate precautions while doing so. "As of date, there is no ban on GM crop field trials neither by the government nor the Supreme Court," Mr Javadekar informed Lok Sabha in reply to a question. A technical expert committee (TEC) was constituted vide Supreme Court order to address issues related to genetically modified crop field trials. It has submitted two final reports - one which has the concurrence of five of its six members and the second by Dr RS Paroda, sixth member. Both the reports have highlighted suggestions for improving the bio-safety regulation in India. Five members of TEC have recommended that the GM crop field trials be put on hold till all recommendations are implemented. The sixth member of TEC has stated that the existing safety norms for field trials prescribed by the Genetic Engineering Appraisal Committee (GEAC) are adequate," Javadekar said. Stating that the GEAC is following a case-by-case assessment of GM crops, the minister further added, "All experimental field trials are conducted as per the stringent norms prescribed in the 'Guidelines and Safety Operating Practices for the Conduct of Confined Field Trials of Transgenic Plant, 2008' which is as per international best practices." ]]> <![CDATA[Europe approves Lilly's diabetes drug ]]> https://biospectrumindia.com/news/95/5771/europe-approves-lillys-diabetes-drug-.html https://biospectrumindia.com/news/95/5771/europe-approves-lillys-diabetes-drug-.html Wed, 26 Nov 2014 14:51:00 +0530 Eli Lily has announced that the European Commission (EU) has granted marketing approval to its injectable once-weekly Trulicity treatment for adults with type 2 diabetes. Trulicity is a GLP-1 receptor agonists. The marketing authorisation is based primarily on six large Phase III trials and in the first five, Trulicity 1.5mg was superior to placebo and four commonly used type 2 diabetes medicines in reducing average blood sugar levels. The drug can be taken any time of a day, with or without meals, and either by itself or with other treatments for the most common form of diabetes. ]]> <![CDATA[Bilcare's nonClonableID Technology awarded by CII]]> https://biospectrumindia.com/news/95/5743/bilcares-nonclonableid-technology-awarded-by-cii.html https://biospectrumindia.com/news/95/5743/bilcares-nonclonableid-technology-awarded-by-cii.html Wed, 26 Nov 2014 14:47:11 +0530 As well as the overall CII Industrial Innovation Grand Award on Bilcare Limited as the 'Most Innovative Company' for the year 2014. The award was handed over at the recently held 'Knowledge Expo 2014' at National Capital Region (NCR). "These two most prized recognitions from CII reinforces the immense value of the nonClonableID technology which possibly is the first disruptive technology that India would give to the World as well as the exemplary commitment of Bilcare Limited towards its Innovation pathway leading to its getting judged as the 'Most Innovative Indian Company," said Dr Praful Naik, chief scientific officer at Bilcare, while receiving these prestigious honours. The conferring of CII Industrial Innovations Awards and the Grand Award 2014 comes after several months of rigorous assessment and comprehensive audit steered by an eminent team of jury members comprising top scientific minds & thought leaders from India and outside with diverse experience and expertise, which included eminent scientists from ISRO, IISc, TIFAC and Directors & Professors of IIT's, IIM's, Cornel, MIT, Washington University, Imperial College London, London Business School. Out of a select 81 applicants, 25 were selected as finalists and 6 were conferred with the category awards in which Bilcare's nonClonableID technology bagged the Manufacturing sector - Large Enterprise category award and finally from amongst the 6 category award winners, Bilcare was selected as the Most Innovative company for the year 2014 across all sectors and conferred with the Grand Award. The CII Industrial Innovation Awards 2014 is the recognition & celebration of innovative Indian enterprises across industry segments. CII Industrial Innovation Awards 2014 is the first one to recognize excellence in Innovation across industry sectors. These premier awards seek to honour the Indian Industry's brightest performers, and top 25 Innovative Organizations in India and select the 6 category award winners from manufacturing and services sector amongst Large, Medium and Micro and Small Enterprises and finally determine the most innovative company for the year 2014 across all sectors and categories. The CII Industrial Innovation awards 2014 conferred at the Knowledge Expo- saw a unique government - industry - academia partnership where CII, Department of Industrial Policy and Promotion, Department of science and technology, Ministry of Human Resource Development and other prominent Institutions converged with a purpose to encourage business growth through innovation, and to recognize innovation excellence. ]]> <![CDATA[Smart agriculture discussed at '4th National Conference on Agribiotech']]> https://biospectrumindia.com/news/95/4777/smart-agriculture-discussed-at-4th-national-conference-on-agribiotech.html https://biospectrumindia.com/news/95/4777/smart-agriculture-discussed-at-4th-national-conference-on-agribiotech.html Wed, 26 Nov 2014 14:42:08 +0530 With highly relevant sessions on the present scenario of agriculture in India, the '4th National Conference on Agribiotechnology' was loaded with equally fruitful discussions and cross talk on important subjects related to agriculture technology, policy implementation and challenges. The event held at New Delhi on November 25-26 was well appreciated by concerend stakeholders of the Indian agriculture sector. Mr Mohanbhai Kundariya, Union Minister of state (agriculture) who interacted with the industry leaders in his inaugural address assured them of all help. He mentioned, "Our Government under the leadership of our Prime Minister, Narendra Modi is committed to working with industry leaders to bring about a revolution in the agricultural sector in India. We will discuss the various issues and challenges around agriculture, agri-biotechnology and other related areas raised during today's conference and come up with measures to provide an impetus to the sector." Stressing on the importance of producing more from the available land and water, Mr Kundariya said, "Technology, like agri-biotechnology, if used intelligently will play an important role in improving our agricultural output especially in the light of our limited land and water resources which are reducing day by day." The opening session of the conference was presided by welcome and introductory remarks given by Mr Ashwin Shroff, co-chairman, CII National Conference on Biotechnology and chairman and MD, Excel Industries. He opined," Last century belonged to India because of IT and this century will belong to India because of biotechnology." He further said that the potential of biotechnology is often curbed by the pulls and pressures of the myths associated with it due to which opportunities are missed. Speaking on the ocassion, Mr Ram Kaundinya, director general, ABLE-AG mentioned, "The need of the hour is a predictive policy that can augur well with the needs of the people and industry. We require a science based system with a streamlined regulatory system. Also, there is a need for political commitment."Mr Kaundinya stressed upon proper infrastructure and support to innovation and technology. He mentioned that there is a need to educate and aware all stakeholders about the evolving technologies. Dr P S Ahuja, director general, Council of Scientific and Industrial Research (CSIR) who was present in the inaugural session laid emphasis on the awareness for right technologies that can benefit the farmers. "There is a need to combat salinity for making it drought resistant," he stated further. Momentum has been lost after the fisrt green revolution, remarked, Mr Rajesh Kumar Singh, joint secretary (Seeds), ministry of agriculture and cooperation, government of India. He, in his address said that there needs to be a harmony in the new seeds bill to bring about positive change. He also added that integration of biotech to farming can revolutionize India. He further added that GM momentum is lost and it needs to be introduced in other areas of technology. The mix of topics including sustainable Resource Use - Challenges and Answers, Lab to field - Successfully Reaping benefits and resolving Farmer & Consumers Challenges - Role of Biotechnology were discussed at length during the conference. The conference was attended by close to 200 persons from the industry, policymakers, academia and geads of research institutes. The recommendations from the two day event shall be sent to the agriculture ministry for further action. ]]> <![CDATA[Govt funding for TB Control goes up in last 3 years]]> https://biospectrumindia.com/news/95/5755/govt-funding-for-tb-control-goes-up-in-last-3-years.html https://biospectrumindia.com/news/95/5755/govt-funding-for-tb-control-goes-up-in-last-3-years.html Wed, 26 Nov 2014 14:28:44 +0530 The Revised National Tuberculosis Control Program by the Government of India encompasses diagnosis and treatment facilities including anti-TB drugs that are provided free of cost to all TB patients. Designated microscopy centers have been established for quality diagnosis for every one lakh population in the general areas and for every 50,000 population in the tribal, hilly, and difficult areas. More than 13,000 microscopy centers have been established in the country. This information was revealed by the minister of health, Mr JP Nadda in the Parliament on November 25, 2014. The health minister while replying to a question, elaborated on the government funding and said, "During the last three years, the money spent for controlling TB has gone up. During 2011-12, the amount spent was Rs 391.16 crore and in 2012-13, it was Rs 467 crore. At the same time, during the year 2013-14, it has been hiked to Rs 500 crore." "Treatment centers (DOT Centers) have been established near to residence of patients to the extent possible. All government hospitals, Community Health Centers (CHC), Primary Health Centers (PHC), sub Centers are DOT Centers. In addition NGOs, Private Practitioners (PPs) involved under the RNTCP, community volunteers, Anganwadi workers, women self-help groups etc., also function as DOT providers/DOT Centers. Drugs are provided under direct observation and the patients are monitored so that they complete their treatment," said Mr Nadda. Taking about the programmatic management of Drug Resistant TB (PMDT) services, Mr Nadda mentioned, "For the management of multi-drug resistant tuberculosis (MDR-TB) and TB-HIV collaborative activities for TB-HIV co-infection are being implemented throughout the country." "As of now, because of the epidemiological pattern of the disease, the Revised National TB Control Program (RNTCP) targets Tuberculosis control and not eradication. Use of irrational treatment regimen is one of the major reasons for development of resistance to anti-TB drugs," he said. Anti-TB Drugs have been moved from Schedule H to H1, under the Drugs and Cosmetics Act, which lays down certain conditions on the usage of these drugs. Government of India has released Standards for TB Care in India (STCI), an initiative to introduce uniform standards for TB care in all sectors. This is the first time such standards have been defined in India and is an important step to standardize diagnosis, treatment, public health action and social support systems for all TB patients in the country. RNTCP is collaborating with the Indian Medical Association in the form of a project for involvement of Private Medical Practitioners. The Central TB Division has entered into a MoU with Indian Pharmacist Association and All India Organization of Chemists and Druggists, SEARPhar Forum and Pharmacy Council of India for inclusion of pharmacies in RNTCP. ]]> <![CDATA[J&J's HIV drug receives EU nod]]> https://biospectrumindia.com/news/95/5772/jjs-hiv-drug-receives-eu-nod.html https://biospectrumindia.com/news/95/5772/jjs-hiv-drug-receives-eu-nod.html Wed, 26 Nov 2014 12:35:51 +0530 Johnson & Johnson's, Janssen-Cilag International NV (Janssen) has announced that the European Medicines Agency (EMA) has granted a positive opinion recommending REZOLSTA (darunavir/cobicistat) in combination with other antiretroviral medicinal products for the treatment of human immunodeficiency virus-1 (HIV-1) infection in adults aged 18 years or older. REZOLSTA is a new once-daily, fixed-dose combination tablet containing darunavir and the pharmacokinetic enhancing or "boosting" agent cobicistat (marketed as Tybost by Gilead Sciences, Inc.). The Janssen filing was based on bioequivalence data evaluating the use of a darunavir and cobicistat fixed-dose combination tablet versus single agents, and a clinical study evaluating the safety and efficacy of cobicistat-boosted darunavir for the treatment of HIV-1 in adults with no darunavir resistance-associated mutations. "People with HIV are living longer than ever before thanks to the development and introduction of effective HIV treatments," said Ms Christiane Moecklinghoff, medical director, virology, Janssen. She added, "For this reason, expanding existing treatment options, especially those which will improve patients' lives by simplifying regimens and supporting adherence are critical. If approved, this new treatment option eliminates the need to take a boosting agent in a separate tablet with once-daily darunavir, reducing the pill burden for patients. We look forward to a final decision from the European Commission in the coming months." ]]> <![CDATA[Mahyco invests in a Zimbabwe firm]]> https://biospectrumindia.com/news/95/4616/mahyco-invests-in-a-zimbabwe-firm.html https://biospectrumindia.com/news/95/4616/mahyco-invests-in-a-zimbabwe-firm.html Tue, 25 Nov 2014 17:26:27 +0530 Maharashtra Hybrid Seeds Company (Mahyco) has announced that it has acquired 60 percent interest in a Zimbabwe-based seed firm, Quton Seed Company, for an undisclosed sum. Quton is the largest cotton seed company in Africa with presence in Zimbabwe, Malawi and Tanzania. The company believes the acquisition will help it reach cotton farmers with small landholdings in Africa. "This acquisition enables us to place ourselves strongly in the African region and is another milestone in the 50th year of our service to farmers," said Mr Raju Barwale, Mahyco managing director in a statement. "The deal will help our company take the business forward in terms of new technologies, particularly the introduction of hybrid cotton seed in Africa" said Mr Morgan Nzwere, group chief executive of Seed Company, the parent of Quton. ]]> <![CDATA[APAC fastest-growing market for alcohol, startch and sugar enzymes]]> https://biospectrumindia.com/news/95/5685/apac-fastest-growing-market-for-alcohol-startch-and-sugar-enzymes.html https://biospectrumindia.com/news/95/5685/apac-fastest-growing-market-for-alcohol-startch-and-sugar-enzymes.html Tue, 25 Nov 2014 17:15:17 +0530 Due to their versatile applications, alcohol enzymes are in great demand to suffice the tremendous requirement for industrial products from consumers. According to Global Trends & Forecasts, the alcohol and starch/sugar enzyme market is projected to be worth $2,238.4 million by 2018 and is expected to grow at a CAGR of 7.9 percent from 2013 to 2018. Asia-Pacific is projected to be the fastest-growing market for alcohol and starch/sugar enzymes. The APAC region is witnessing a steady demand for alcohol and starch/sugar enzymes due to the expansion strategies of global industrial and pharmaceutical companies situated in this region. Rapid industrialization and development in infrastructure as well as co-operation from local governments has driven the market for alcohol and starch/sugar enzymes in the Asia-Pacific region. The US wine market is the world's second largest markets, which is estimated to increase the demand of alcohol enzymes to process wine. The US is the most important contributor for the growth of starch/sugar enzymes market in North America. Extensive investments are made in research and development to develop advanced products so that the maximum market share can be occupied by introducing new and improved products to suffice the customers' demands. The market for alcohol and starch/sugar enzymes is anticipated to generate significant amounts of revenues considering the rise in demand for food and beverages, biofuels, cleaning agents, pharmaceuticals, biocatalysts, along with research and biotechnology products. The US is a key market in the North American region for alcohol and starch/sugar enzymes due to extensive pharmaceuticals production and research & biotechnology applications. Massive investments in research and development for new products drive the demand for alcohol and starch or sugar enzymes, tremendously. ]]> <![CDATA[Dr Reddy's cancer drug hits the US market]]> https://biospectrumindia.com/news/95/3857/dr-reddys-cancer-drug-hits-the-us-market.html https://biospectrumindia.com/news/95/3857/dr-reddys-cancer-drug-hits-the-us-market.html Tue, 25 Nov 2014 12:21:02 +0530 Dr Reddy's Laboratories has launched Docetaxel injection USP 20 mg/mL and 80 mg/4 mL, a generic version of Taxotere (docetaxel injection) in the US market. According to the company, Docetaxel injection USP 20 mg/mL and 80 mg/4 mL are available as a single dose, one vial formulation that does not require a prior dilution with a diluent and is ready to add to the intravenous infusion solution. Taxotere (docetaxel) is a cancer medication that interferes with the growth and spread of cancer cells in the body. ]]> <![CDATA[CCI nod for Mylan-Abbott deal]]> https://biospectrumindia.com/news/95/4443/cci-nod-for-mylan-abbott-deal.html https://biospectrumindia.com/news/95/4443/cci-nod-for-mylan-abbott-deal.html Tue, 25 Nov 2014 11:57:21 +0530 The proposed merger of Abbott Laboratories' Established Pharmaceuticals Products (EPP) segment with the Mylan has received green signal from the Competition Commission of India (CCI). As per the deal, the EPP segment of Abbott would be transferred to the Netherlands-based New Moon BV, a private limited liability company set up by Mylan for the proposed combination. EPP segment includes branded generics and speciality pharmaceuticals products business of Abbott in Europe, Japan, Australia, New Zealand, and Canada. "The proposed combination is not likely to have an appreciable adverse effect on competition in India and the horizontal overlap between the pharmaceutical products of Mylan and Abbott in India is insignificant to raise any competition concern in India," CCI said in a statement. ]]> <![CDATA[Saamya Biotech appoints new additional director]]> https://biospectrumindia.com/news/95/5501/saamya-biotech-appoints-new-additional-director.html https://biospectrumindia.com/news/95/5501/saamya-biotech-appoints-new-additional-director.html Mon, 24 Nov 2014 17:23:53 +0530 Saamya Biotech India has informed Bombay Stock Exchange (BSE) that Mr Kishan Kumar Srishankar Jha, has been appointed as the company's additional director with effect from November 18, 2014. ]]> <![CDATA[Sanofi outlines next wave of innovative medicines and vaccines]]> https://biospectrumindia.com/news/95/5506/sanofi-outlines-next-wave-of-innovative-medicines-and-vaccines.html https://biospectrumindia.com/news/95/5506/sanofi-outlines-next-wave-of-innovative-medicines-and-vaccines.html Mon, 24 Nov 2014 17:21:00 +0530 These new launches have the potential to cumulatively generate greater than â‚¬30 billion over the first five years of sales and confirm the strong momentum of the company's R&D pipeline and ability to deliver new therapies across a range of therapeutic categories. "These potential launches affirm Sanofi's strategy, which has been in place since 2008, and clearly demonstrate the strong momentum of Sanofi's R&D pipeline," said Mr Serge Weinberg, chairman of the Board and CEO, Sanofi. "As we move into this period of successive new product launches, we are investing in launch excellence and execution while continuing to fuel innovation to grow our existing pipeline." Sanofi's seminar consisted of presentations on nine new medicines and vaccines: â€¢ Rare Diseases: o Cerdelga (eliglustat): The only FDA-approved, first-line oral therapy for certain adult Gaucher Disease Type 1 patients. â€¢ Multiple Sclerosis: o Lemtrada (alemtuzumab): An FDA-approved treatment for adult patients with active relapsing remitting multiple sclerosis who have had an inadequate response to two or more MS therapies. â€¢ Cardiovascular Disease: o Praluent (alirocumab): An investigational monoclonal antibody targeting PCSK9 (proprotein convertase subtilisin/kexin type 9) with the potential to transform LDL-cholesterol management - developed in collaboration with Regeneron - is expected to be submitted to U.S. and EU regulatory agencies before year-end 2014. â€¢ Diabetes: o Toujeo (insulin glargine [rDNA origin] injection, 300 U/mL): A new investigational basal insulin currently under review by the US and EU regulatory agencies.o Afrezza (insulin human): A new, FDA-approved, rapid-acting inhaled insulin therapy for adults with type 1 and type 2 diabetes. o Lixilan: An investigational fixed-ratio combination of insulin glargine, the leading basal insulin, with lixisenatide, a GLP-1 receptor agonist, in a single daily injection for the treatment of adults with type 2 diabetes. â€¢ Vaccines: o Dengue Vaccine: Sanofi Pasteur's dengue vaccine candidate with demonstrated efficacy across all dengue serotypes and a favorable safety profile in two landmark phase 3 studies, after 25 months active surveillance period. Regulatory submissions are planned in 2015. â€¢ Immunology & Inflammation: o Sarilumab: An investigational fully human monoclonal antibody targeting the IL-6 receptor (IL-6R) - developed in collaboration with Regeneron - currently being studied in patients with rheumatoid arthritis (RA).o Dupilumab: An investigational fully human monoclonal antibody that blocks IL-4 and IL-13 signaling - developed in collaboration with Regeneron - entered into phase 3 in adults with moderate-to-severe atopic dermatitis. Positive results were also recently announced with dupilumab also in phase 2b in adult patients with uncontrolled, moderate-to-severe asthma and in phase 2a in chronic sinusitis with nasal polyps. "Sanofi's global R&D teams have created an impressive dynamic that leverages internal talents and open innovation to develop an industry-leading pipeline," said Mr Elias Zerhouni, MD, president, and global R&D, Sanofi. "Sanofi has the potential to launch up to six new medicines in 2015 and approximately one new medicine every six months between 2016 and 2018. These new medicines have the potential to help address significant areas of need in rare diseases, cardiovascular care, diabetes, immunology and public health." ]]> <![CDATA["Antibiotic resistance is a serious threat"]]> https://biospectrumindia.com/interviews/95/4070/antibiotic-resistance-is-a-serious-threat.html https://biospectrumindia.com/interviews/95/4070/antibiotic-resistance-is-a-serious-threat.html Mon, 24 Nov 2014 10:44:00 +0530 Q: How do you look at the growing threat of anti-microbial resistance? It is really as alarming as perceived? Antimicrobial resistance till date is most often associated with nosocomial infections (hospital based infections), and reports on these are limited in India. But there have been reports on emergence of superbug, NDM-1 which in itself is a disaster as it is resistant to even high-end drugs like carbapenems. We being a private diagnostic setup and based on our internal data, would be considered as community acquired AMR data also seems worrisome. High level and continuously increasing levels of resistance has been noted for most of the gram negative and gram positive organisms. Yes, such data hints at the seriousness of the issue and should be considered as a threat. Q: What are the factors that are responsible for it? Are there any remedial measures? Factors are multi-rationale include the inappropriate use or unregulated use of high-end antibiotics in private practice. Besides that the patients discontinuing therapy midway i.e. not completing revommended treatment duration. In such cases, the bug manipilates in such a way such that it overcomes the antibiotic effect (a phenomenon called as acquired drug resistance). Therefore patients should stop taking such decisions without consultation with their doctors.Remedies for both these are: Doctors need to go in for lab based antimicrobial susceptibility testing so as to avoid prescribing high end drugs. Empirical therapy with high successful treatment rates would be encouraging for now but in the long run the clinicians would have no effective drugs left to treat with. Q: Shouldn't the government improve regulatory scenario vis a vis prescriptions and sale of antibiotics? Can't it run a broader awareness programme on the issue? Stringent regulations to control over the counter sale of drugs have been under the governmental agenda over a long time. But immediate control and regulation seems difficult. Also the influence, role and reliability on private sector doctors needs to be taken into consideration to effectively lay down such regulations. Q: What is the way forward so as to maintain the balance between overexposure and dire need? How can companies play a role? Companies would be producing drugs and selling them since there is a need.Doctors are the best to decide and differentiate between the true need and estimate the chances of overexposure. While drug manufacturing companies can only be regulated in the presence of released governmental ordinance only. For eg. The recent pricing policy regulation on certain essential drugs for treatment of certain disease conditions like diabetes cancer which have badly hit the society. ]]> <![CDATA[Apollo Hospitals inks pact with Fiji univ for healthcare]]> https://biospectrumindia.com/news/95/5096/apollo-hospitals-inks-pact-with-fiji-univ-for-healthcare.html https://biospectrumindia.com/news/95/5096/apollo-hospitals-inks-pact-with-fiji-univ-for-healthcare.html Fri, 21 Nov 2014 16:13:00 +0530 Apollo Hospitals has signed a memorandum of understanding (MoU) with the Fiji National University to upgrade and improve healthcare services in Fiji through the construction of an Apollo Tele-clinic. The MoU was signed by joint managing director of Apollo Group of Hospitals, Ms Sangita Reddy and vice-chancellor of Fiji National University.The MoU entails initiatives including enhancement of the healthcare infrastructure in Fiji, enabling better access to high quality care for the people there using telemedicine facilities and sharing of content on medical education and training programmes. It also facilitates patients to be referred to Apollo Hospitals for advance treatment. "Through the establishment of the Tele-Clinic we will be strengthening our ties with FNU as well as the Fiji Government," said Ms Reddy. ]]> <![CDATA[GSK collaborate with Clovis Oncology ]]> https://biospectrumindia.com/news/95/5090/gsk-collaborate-with-clovis-oncology-.html https://biospectrumindia.com/news/95/5090/gsk-collaborate-with-clovis-oncology-.html Fri, 21 Nov 2014 14:43:58 +0530 Clovis Oncology and GlaxoSmithKline have entered into a clinical trial collaboration to evaluate a novel combination therapy targeting mutant epidermal growth factor receptor (EGFR) non-small cell lung cancer (NSCLC). The Phase 1/2 trial of rociletinib given in combination with trametinib is planned to start in early 2015. The trial is designed to assess the safety and activity of the combination in patients with EGFR mutant NSCLC who were previously treated with an EGFR tyrosine kinase inhibitor (TKI). "We have seen significant activity in EGFR mutant NSCLC patients treated with rociletinib monotherapy, and so an important next step in our research is to examine rociletinib in combination with other targeted therapies that may also impact acquired resistance to EGFR inhibitors," said Ms Lecia V Sequist, Massachusetts General Hospital Cancer Center and Associate Professor of Medicine at Harvard Medical School and the lead investigator for this combination study. "As we continue to see compelling activity for rociletinib single-agent therapy at our selected dose, we look forward to exploring combination trials in both T790M-positive and T790M-negative patients," said Mr Patrick J Mahaffy, president and CEO, Clovis Oncology. He added, "We believe that given the tolerability profile of rociletinib, particularly its lack of cutaneous toxicity, it may be a good candidate for combination therapy with trametinib, and other relevant targeted therapies. We intend to announce additional combination studies over the next few months." This clinical trial is designed to test the hypothesis that the combination of two oral drugs targeting different cellular growth pathways, both often active in EGFR mutant NSCLC, will lead to augmented clinical benefit. ]]> <![CDATA[Agilent, Eppendorf, Millipore & others honored]]> https://biospectrumindia.com/news/95/5100/agilent-eppendorf-millipore-others-honored.html https://biospectrumindia.com/news/95/5100/agilent-eppendorf-millipore-others-honored.html Fri, 21 Nov 2014 14:19:00 +0530 The awards were presented by BioInformatics LLC, the premier market research and advisory firm serving the life science industry. The event was attended by industry executives and product and marketing professionals from 41 life science companiesUsing industry best-practices market research methodologies, almost 6,000 scientists were surveyed to reveal preferred suppliers in 28 product, communications, and support categories. These scientists were drawn from BioInformatics LLC's online panel of scientists, The Science Advisory Board. From the data collected, BioInformatics LLC analysts calculated an overall score for each nominated company based on the number of nominations received, as well as key measurements of customer satisfaction and loyalty. "The vision and foresight of the companies we honored last night have made possible many of the scientific advances of the past decade," said Ms Jennifer Cotteleer, CEO of BioInformatics LLC. "Life science tools companies are the foundation upon which biological research and drug discovery rest and we are proud to support them in understanding the needs of their scientific customers." The Winners of the prestigious 2014 Life Science Industry Awards® are: Abcam Best Use of Digital Media Agilent TechnologiesBest High Throughput Screening & Analysis Systems Becton, Dickinson & Co. Best Cell Analysis Instruments (Flow Cytometer-Based)Best Technical SupportBest Workflow Solutions - Cell-Based ResearchMost Memorable Advertising Bio-Rad Laboratories Best Protein Expression & Analysis ProductsBest Workflow Solutions - Genomics Carl ZeissBest Cell Biology Instruments (Microscope-Based)Breakthrough Product - Neuroscience Research Cell Signaling TechnologyBest AntibodiesMost Useful Website EMD/Merck Millipore"Greenest" Life Science Company EppendorfBest General Lab Equipment GE Healthcare Life Sciences Best Instrumentation for Protein Analysis & PurificationBest Protein Purification & Separation Products IlluminaBest High Throughput Sequencing Platform Life Technologies (Thermo Fisher Scientific)Best Cell Biology ProductsBest Cell Culture Media & ReagentsBest Genomics Analysis Kits & ReagentsBest Instrumentation for Genomic Analysis New England BiolabsBest Molecular Biology Products QIAGEN Best Nucleic Acid Purification & Separation ProductsMost Helpful Sales Force Seahorse BioscienceCompany to Watch in 2015Sigma-AldrichBest Customer Service Thermo Fisher ScientificBest Workflow Solutions - Proteomics2014 Market Leadership Award ]]> <![CDATA[Cipla to market Serum India Institute's paediatric vaccines in Europe]]> https://biospectrumindia.com/news/95/4957/cipla-to-market-serum-india-institutes-paediatric-vaccines-in-europe.html https://biospectrumindia.com/news/95/4957/cipla-to-market-serum-india-institutes-paediatric-vaccines-in-europe.html Thu, 20 Nov 2014 12:55:00 +0530 Cipla Europe NV, a global pharmaceutical company has signed a distribution agreement with Serum Institute of India Ltd to market the paediatric vaccines in Europe. Cipla will seek European Medicines Agency approval and market the products in Europe. With this tie-up Cipla has entered in to vaccines segment. The vaccines will be manufactured in Serum's production facilities approved by WHO. Commenting on the collaboration, Mr Subhanu Saxena, MD and Global CEO, Cipla said: "We are proud to have entered into a strategic Europe-specific partnership with Serum Institute of India. This collaboration is aligned with our commitment to access to affordable paediatric healthcare. Both Cipla and SII share the same core values such as self-sufficiency, affordability, accessibility, quality and commitment to global health. Through this partnership, we look forward to contribute in eradication of childhood diseases." Mr Adar Poonawalla, CEO and executive director, SII said, "Serum Institute believes that this tie-up with Cipla is a perfect platform for making vaccines available for Europeans as Serum also shares the common philosophy of Cipla of making vaccines/pharmaceutical products available at the most affordable prices. Therefore as the two companies are aligned in many ways, we feel this will be a good partnership." Over the last 6 months, Cipla has strengthened its foundation in Europe. The company has launched respiratory products such as Salmeterol/Fluticasone in Germany and Sweden, Czech Republic, Slovakia and Croatia. In July, Cipla has signed an exclusive partnership with BioQuiddity to market OneDoseReadyfusORTM in regional anesthetic applications for post-surgical pain management. ]]> <![CDATA[Genzyme's Lemtrada approved by USFDA]]> https://biospectrumindia.com/news/95/6496/genzymes-lemtrada-approved-by-usfda.html https://biospectrumindia.com/news/95/6496/genzymes-lemtrada-approved-by-usfda.html Wed, 19 Nov 2014 16:16:06 +0530 Multiple sclerosis is estimated to affect more than 2.3 million people globally. The FDA approval of Lemtrada is based on two pivotal randomized Phase III open-label rater-blinded studies comparing treatment with Lemtrada to Rebif (high-dose subcutaneous interferon beta-1a) in patients with relapsing remitting MS who were either new to treatment (CARE-MS I) or who had relapsed while on prior therapy (CARE-MS II). "The approval is the culmination of more than a decade of work by Genzyme to develop Lemtrada," said C's president and CEO, Mr David Meeker. Lemtrada has a unique dosing and administration schedule of two annual treatment courses. The first treatment course is administered via intravenous infusion on five consecutive days, and the second course is administered on three consecutive days, 12 months later. First approved in September 2013 in the European Union, Lemtrada is approved in more than 40 countries. Additional marketing applications for Lemtrada are under review by regulatory agencies around the world. The FDA approval of Lemtrada marks Genzyme's second MS treatment approval in the United States. Genzyme received FDA approval of its once-daily, oral Aubagio (teriflunomide) for the treatment of relapsing forms of MS in September 2012. Aubagio is approved in more than 50 countries, and is under review by additional regulatory agencies. Between clinical trials and commercial use, approximately 30,000 patients have been treated with Aubagio. ]]> <![CDATA[USP to enhance pharma and biotech connections in India]]> https://biospectrumindia.com/news/95/4861/usp-to-enhance-pharma-and-biotech-connections-in-india.html https://biospectrumindia.com/news/95/4861/usp-to-enhance-pharma-and-biotech-connections-in-india.html Wed, 19 Nov 2014 16:14:57 +0530 Staff from the US Pharmacopeial Convention (USP) welcomed a visiting delegation of community and business leaders from Montgomery County, Maryland to USP's laboratories in Hyderabad, India as part of an effort to strengthen connections with pharmaceutical and biotech organizations. "We are happy to welcome this delegation from Montgomery County, where USP is headquartered, and we appreciate their interest in fostering economic development at home and in India," said USP's CEO Dr Ronald T Piervincenzi. "The County's efforts have helped USP further its mission to advance public health by promoting access to quality medicines and foods, which increasingly include ingredients from India and other global sources." USP-India is located in the IKP Knowledge Park in Hyderabad, a center for pharmaceutical and biotech manufacturing and research in India. In addition to showcasing USP's laboratories and testing facilities, USP-India hosted meetings to introduce the Montgomery County delegation to leaders from other businesses located in the IKP Park. Opened in 2005, the Hyderabad site is USP's first office and laboratory facility located outside of the United States. In 2011, USP completed a large-scale expansion project to increase capacity for analytical chemistry and collaborative testing. In addition to India, USP operates laboratories in SÃ£o Paulo, Brazil; Shanghai, China; and at USP's headquarters in Rockville, Maryland. (USA). ]]> <![CDATA[Man quarantined in Delhi amid Ebola scare]]> https://biospectrumindia.com/news/95/4856/man-quarantined-in-delhi-amid-ebola-scare.html https://biospectrumindia.com/news/95/4856/man-quarantined-in-delhi-amid-ebola-scare.html Wed, 19 Nov 2014 16:13:27 +0530 An Indian national who had contracted the deadly Ebola infection in Liberia, landed in Delhi with a certificate claiming that he was cured of Ebola. The man has been kept under quarantine at the Airport Health Organization's quarantine center at Delhi Airport. The 26-year-old man is the first confirmed patient to have landed in India. Though his blood samples tested negative for Ebola in three different tests conducted at the National Institute of Virology (NIV) in Pune and National Center for Disease Control (NCDC) in Delhi, ministry officials confirmed that his semen samples, which were analyzed on November 17, tested positive for the virus. Authorities said that the man was quarantined as a matter of abundant caution to prevent the spread of the disease sexually. "Presence of virus in his semen samples may have the possibility of transmitting the disease through sexual route up to 90 days from time of clinical cure,"said the ministry in a statement. The ministry further said , "Currently, this person does not have any symptoms of the disease. However, he would be kept under isolation... till such time his body fluids test negative and he is found medically fit to be discharged. It is reiterated that the person concerned is a treated and cured case of Ebola virus disease. No cases of relapse of Ebola have been documented." ]]> <![CDATA[IMA Medicine Millennium International Award for Dr Moopen]]> https://biospectrumindia.com/news/95/4855/ima-medicine-millennium-international-award-for-dr-moopen.html https://biospectrumindia.com/news/95/4855/ima-medicine-millennium-international-award-for-dr-moopen.html Wed, 19 Nov 2014 15:32:35 +0530 The Indian Medical Association had recently announced the 57th Medicine Millennium International Awards in a three-day conference held in Kovalam. Dr Robert Gallo, co-inventor of HIV, Dr Azad Moopen, chairman and managing director - Aster DM Healthcare and Dr Narendra Kumar, president of Association of Physicians of India were the proud recipients of the award this year. Mr Oommen Chandy, Chief Minister of Kerala presented the awards to the eminent scientists marking their tremendous contribution towards medical sciences and developing medical facilities globally. Dr Moopen received the award for making speciality care available across the globe. Dr Moopen has the largest chain of multi-specialty networks across the globe and over 200 establishments that consists of hospitals, medical centers, diagnostics, pharmacies that include a wide spectrum of healthcare services from primary care to quaternary care. Acknowledging his immense contribution towards science and his the ultimate discovery of the HIV virus, the IMA conferred the Medical Millennium International Award upon Dr Robert Gallo, an American biomedical researcher and the director and co-founder of the Institute of Human Virology (IHV) at the University of Maryland, School of Medicine in Baltimore, Maryland. Dr Gallo is also a co-founder of biotechnology company Profectus BioSciences, and co-founder and scientific director of the Global Virus Network. Dr Kumar, the president of American Association of Physicians of Indian Origin (AAPI,) with nearly 100,000 doctors registered as members, was recognized for his immense contribution to the medical fraternity. ]]> <![CDATA[India sets up a Ministry to regulate traditional medicine]]> https://biospectrumindia.com/news/95/4852/india-sets-up-a-ministry-to-regulate-traditional-medicine.html https://biospectrumindia.com/news/95/4852/india-sets-up-a-ministry-to-regulate-traditional-medicine.html Wed, 19 Nov 2014 15:13:51 +0530 In a bid to promote alternative medicine and natural therapies, the Indian government under the leadership of Prime Minister Mr Narendra Modi has set up ministry to raise awareness about the potential of traditional medicines and draft a policy to address these treatment options. PM Modi has been a great supporter of alternative therapies and has advocated yoga as a means to lead a healthy lifestyle. The PM even called for an International Yoga Day during his speech at the United Nations. Mr Shripad Naik, who took charge of the ministry, said, "This is our system and it has not received enough prominence. We will take it to the masses." India wants to expand its presence in the global market of traditional medicine which is estimated to be a $100 billion market in the coming years. Further support from the government in terms of budgetary allocation can help in fostering the sector to a large extent. The government had allocated $174 million to develop and promote traditional health systems in the 2014-15 financial year. ]]> <![CDATA[Merck, Pfizer collaborate on anti-cancer immunotherapy]]> https://biospectrumindia.com/news/95/4826/merck-pfizer-collaborate-on-anti-cancer-immunotherapy.html https://biospectrumindia.com/news/95/4826/merck-pfizer-collaborate-on-anti-cancer-immunotherapy.html Wed, 19 Nov 2014 15:00:37 +0530 Pfizer and Merck & Co have entered into an agreement to explore the therapeutic potential of the combination of Pfizer's crizotinib (XALKORI) with Merck's investigational anti-PD-1 antibody pembrolizumab, in a Phase 1b clinical trial. The study will evaluate the safety and tolerability of the combination in patients with ALK-positive advanced or metastatic non-small cell lung cancer (NSCLC). "This collaboration between Pfizer and Merck is just one example of the willingness of sponsors to work together in an effort to accelerate progress against some of the most difficult-to-treat cancers," said Dr Mace Rothenberg, senior vice president of clinical development and medical affairs and chief medical officer for Pfizer Oncology. "Understanding the effects of combining one drug, XALKORI, which inhibits an abnormally activated enzyme in patients with ALK-positive metastatic lung cancer, with the investigational drug, pembrolizumab, which harnesses the body's immune system to fight cancer, is vital if we are to continue to advance the care of lung cancer patients." This multi-center, open-label clinical study is expected to begin in 2015. Pfizer will conduct the study. According to Dr Eric Rubin, vice president, oncology, Merck Research Laboratories, "We are pleased to build upon our ongoing collaboration with Pfizer to evaluate potential combination regimens incorporating Merck's investigational immunotherapy pembrolizumab. Evidence from early studies of pembrolizumab monotherapy together with XALKORI's proven targeted therapeutic approach provides the scientific rationale for evaluating this combination for the treatment of lung cancer." The financial terms of the agreement were not disclosed. ]]> <![CDATA[Sun Pharma recalls its drug in the US]]> https://biospectrumindia.com/news/95/4834/sun-pharma-recalls-its-drug-in-the-us.html https://biospectrumindia.com/news/95/4834/sun-pharma-recalls-its-drug-in-the-us.html Wed, 19 Nov 2014 14:56:00 +0530 Sun Pharma has decided to recall 68,194 bottles of its Venlafaxine Hydrochloride Extended-Release tablets, an anti-depression in the US. The company is recalling the drug for failing "dissolution specification". The 37.5 mg tablets in 30-count bottles and 90-count bottles, were manufactured by Sun Pharmaceutical Industries at Halol for Sun Pharma Global, Dubai. The withdrawal was classified as a Class-II recall, which the FDA defines as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. ]]> <![CDATA[Rat poison linked to Chhattisgarh sterilisation deaths]]> https://biospectrumindia.com/news/95/4830/rat-poison-linked-to-chhattisgarh-sterilisation-deaths.html https://biospectrumindia.com/news/95/4830/rat-poison-linked-to-chhattisgarh-sterilisation-deaths.html Wed, 19 Nov 2014 12:14:45 +0530 Singapore: Recently a government-run family planning campaign in the state of Chhattisgarh in India ended tragically for atleast 15 women who lost their lives amid a sterilization procedure. There are allegations that the women were administered antibiotics tainted with rat poison during the procedure. Preliminary tests of ciprocin tablets made by Mahawar pharmaceuticals indicated the presence of zinc phosphide in the tablets, a chemical commonly found in rat poison. Samples have been sent to Kolkata and Delhi to verify the contamination. Mr Ramesh Mahawar, managing director, Mahawar pharmaceuticals, said that the company did not indulge in any malpractice and had followed all safety measures while formulating the drug. He also added that the information related to the incident was exaggerated and misquoted. Mr Mahawar said that the company will totally cooperate with the government in the investigation procedure. The state government has banned the sale and distribution of all medicines manufactured by Mahawar Pharmaceuticals. It has seized 200,000 tablets of Ciprocin 500 and more than 4 million other tablets made by the company. The company had dispatched 152,000 tablets from the same batch in the first week of October to four drug stockists in districts across Chhattisgarh. This is not the first time that Mahawar pharmaceutical is in legal scrutiny for quality compliance. Earlier in 2012, the company was banned from manufacturing for 90 days following a probe that led to the discovery of sub-standard drugs produced. ]]> <![CDATA[Aurobindo Pharma promoter escapes attempt on life]]> https://biospectrumindia.com/news/95/4814/aurobindo-pharma-promoter-escapes-attempt-on-life.html https://biospectrumindia.com/news/95/4814/aurobindo-pharma-promoter-escapes-attempt-on-life.html Wed, 19 Nov 2014 11:15:00 +0530 Hyderbad: Aurobindo Pharma Ltd's vice-chairman K Nityananda Reddy escaped an attempt on his life on Wednesday morning. A miscreant, armed with an AK-47 gun, confronted Mr. Reddy when he boarded his car after his morning walk at the KBR Park. Media reports suggests that the miscreant allegedly tried to fire at Mr Reddy. Without succeeding, the attacker reportedly panicked and ran towards a building nearby. He left behind an AK 47 gun and the bag in which he had brought the rifle. Founded in 1986 by Mr. P.V. Ramaprasad Reddy, Mr. K. Nityananda Reddy, Aurobindo Pharma is a major player in Semi-Synthetic Penicillins and it has a presence in key therapeutic segments such as neurosciences, cardiovascular, anti-retrovirals, anti-diabetics, gastroenterology and cephalosporins, among others. Mr Reddy is its whole-time director and vice chairman and has been associated with the company as a promoter. He supervises the overall affairs of the company. Aurobindo Pharma features among the top 10 companies in India in terms of consolidated revenues. ]]> <![CDATA['We aim at empowering agriculture with biotechnology']]> https://biospectrumindia.com/interviews/95/6868/we-aim-at-empowering-agriculture-with-biotechnology.html https://biospectrumindia.com/interviews/95/6868/we-aim-at-empowering-agriculture-with-biotechnology.html Wed, 19 Nov 2014 10:50:00 +0530 Dublin's Science Gallery International has signed a Memorandum of Agreement with Karnataka state government to set up Asia's first science gallery in Bengaluru's IISC campus. The gallery will exhibit innovations and latest developments in the field of science. Speaking to BioSpectrum at the signing event, Mr SR Patil, minister, IT, BT, S&T revealed a few initiatives undertaken by the government to foster the agricultural sector of India. Q. What are your unique plans to develop science and technology in India? India is an agricultural country and 70 percent of our people still rely on it. Development of the agricultural sector of the country will be a hallmark approach towards making India a developed country. The economy of the country too, largely depends on the agricultural sector. We are planning to revolutionize the practices through biotech-led innovations and research. The country is aiming at forming an Agro-Biotech Vision group that will nurture the Indian agricultural sector with biotechnology solutions and improve the economy. The vision will encourage biotech research in innovations by providing funding and expertise to enhance research in the agro-biotech field, thus empowering farmers with biotech supported agriculture. We will harness the power of biotechnology in solving major agricultural problems and also develop innovative solutions to foster the agro sector in India. Q. What will the main focus of the Agro- Biotech vision group? In the past, the intersection of biotechnology and agriculture has led to unique crops like Bt Cotton that had huge financial benefits as it prevented crop failures by protecting them from ball disease. Keeping the interest of the society in mind we aim at bringing in biotechnology-led solutions to solve agricultural problems. We are planning to develop safe and better biotech solutions for agriculture that can help in boosting innovations and encouraging biotech-led agriculture in the country. ]]> <![CDATA[UNFAO warning just a scare: Mr Devinder Sharma]]> https://biospectrumindia.com/news/95/7820/unfao-warning-just-a-scare-mr-devinder-sharma.html https://biospectrumindia.com/news/95/7820/unfao-warning-just-a-scare-mr-devinder-sharma.html Wed, 19 Nov 2014 10:26:00 +0530 Q: What kind of effect will Ebola have on food security globally and how important is UNFAO's warning in this regard? The global warning by FAO on food security is nothing more than a scare. There is no evidence that Ebola outbreak will impact food production globally. In fact, at a time when there is a supply glut globally and prices have crashed after a 10-year hike that has been witnessed, there is no threat from Ebola that even food importing countries need to be worried about. Q: Would there be any direct impact on India in terms of food security due to Ebola? No. There is no direct impact on India as far as its food security needs are concerned. Already, India is saddled with huge carryover stocks of wheat, rice and sugar. We do not import staple food and therefore there is no reason fr any alarm. Q: Whether India really can ignore food security threats as its imports from Europe, US and Africa might get affected due to global shortage? As I said earlier, the threat on food security is limited to only three countries -- Guinea, Liberia and Sierra Leone. In any case, these countries were food importing and their imports might increase now. But for the rest pf the world there is nothing to worry. Such scares were also sounded a few decades back when HIV was expected to hit developing countries in Africa and Asia like a bomb. At that time, the scare came in handy for GM companies to promote GM crops saying that since the rural population is being affected by Human Immunodefficiency Virus (HIV) virus, there is shortage of farm workers and therefore the need to have GM crops which do not need the same kind of labour that is required for spraying pesticides. This was proposed by Madison Initiative in collaboration with CGIAR and tried in Kenya. Q: Are we prepared? How can we improve the condition of our food stocks in any such eventuality? India's food stocks are in a comfortable position. There is no need to panic. ]]> <![CDATA[Dietary habits of diabetics similar to normal people]]> https://biospectrumindia.com/news/95/4679/dietary-habits-of-diabetics-similar-to-normal-people.html https://biospectrumindia.com/news/95/4679/dietary-habits-of-diabetics-similar-to-normal-people.html Wed, 19 Nov 2014 10:00:00 +0530 Bayer Zydus Pharma, in collaboration with Prof. Dr Shashank Joshi (Padma Shri awardee and president of Association of Physicians of India) and nine other imminent endocrinologists/diabetologists, conducted the STARCH study across five regions in India - North, South, East, West, and Central India. STARCH stands for Study To Assess the dietaRy CarboHydrate content of Indian type-2 diabetes population. The study was conducted with the objective to assess the total and complex carbohydrate content in the daily diet of the diabetes population. The study published in the journal BMJ Open shows that the Indian diabetes population consumes higher than recommended carbohydrates in their diet (64.1 percent energy comes from carbohydrates). The study also assessed the blood glucose control in diabetes participants and observed that only 33.1 percent have blood glucose within recommended levels (i.e. HbA1c < 7 percent). Further, there was clear non-adherence (only 38.1 percent) to the diet plan advised by their physician/dietician. "Diabetes is emerging as a major health issue for India. Through the STARCH study we hope to provide medical professionals valuable insights on the carbohydrate consumption patterns across India and its impact on diabetes management. The STARCH study is our endeavor to improve the life of our patients and is in line with our mission at Bayer Science for a Better Life" said Mr Angel-Michael Evangelista, MD, Bayer Zydus Pharma According to Dr Shashank Joshi, lead Investigator of the study, "The STARCH study highlights the fact that carbohydrates are consumed widely across India and not only in South of India. This is contrary to the myth that people in the Southern part of the country consume higher carbohydrates in their meals. Even if diabetes participants know that they have diabetes and need to follow certain diet patterns, they do not necessarily adhere to it." In the diabetes group, the mean percentage of total energy intake from carbohydrates was 64.1 percent, which is much higher than the upper limit of 60 percent as recommended by the National Institute of Nutrition. High carbohydrate consumption amongst people with diabetes is associated with abnormal blood sugar levels, particularly the post-meal blood sugar levels. In conclusion to the study results, Dr Joshi says, "As clinicians, we need to ensure that the patients are provided with proper diet counselling with support from a dietician if required." ]]> <![CDATA[Actavis acquires Allergan for $66 bn]]> https://biospectrumindia.com/news/95/4732/actavis-acquires-allergan-for-66-bn.html https://biospectrumindia.com/news/95/4732/actavis-acquires-allergan-for-66-bn.html Tue, 18 Nov 2014 16:54:04 +0530 In one of the biggest acquisition deals of the year, global pharmaceutical firm, Actavis has acquired Allergan at $66 billion. "This acquisition creates the fastest growing and most dynamic growth pharmaceutical company in global healthcare, making us one of the world's top 10 pharmaceutical companies," said Mr Brent Saunders, CEO and President, Actavis. "We will establish an unrivaled foundation for long-term growth, anchored by leading, world-class blockbuster franchises and a premier late-stage pipeline that will accelerate our commitment to build an exceptional, sustainable portfolio. The combined company will have a strong balance sheet, growing product portfolios and broad commercial reach extending across 100 international markets. Our combined experienced management team is dedicated to driving strong organic growth while capturing synergies and maintaining a robust investment in strategically focused R&D. "This is a financially compelling transaction. With pro forma revenues in excess of $23 billion anticipated in 2015, this combination doubles the revenue generated by our brands business and doubles the international revenue of the combined company. The combination is expected to generate strong free cash flow of more than $8 billion in 2016 and substantial growth thereafter, which will enable the rapid repayment of debt. We expect that the combination will result in double-digit accretion to non-GAAP earnings within the first 12 months." "Today's transaction provides Allergan stockholders with substantial and immediate value, as well as the opportunity to participate in the significant upside potential of the combined company," said Mr David E I Pyott, chairman and CEO, Allergan. ]]> <![CDATA[J&J drug for schizoaffective disorder gets FDA nod]]> https://biospectrumindia.com/news/95/4696/jj-drug-for-schizoaffective-disorder-gets-fda-nod.html https://biospectrumindia.com/news/95/4696/jj-drug-for-schizoaffective-disorder-gets-fda-nod.html Tue, 18 Nov 2014 14:55:38 +0530 The US Food and Drug Administration (US FDA) has approved Johnson and Johnson's atypical long-acting antipsychotic paliperidone palmitate (Invega Sustenna, Janssen Pharmaceuticals,) for schizo-affective disorder, either as once-monthly monotherapy or as an adjunctive treatment. The approval was based on trial data that showed the drug was being significantly more effective than placebo in delaying relapse because of mood and psychotic symptoms. The drug was previously approved for acute and maintenance therapy for schizophrenia. "Clinicians often find themselves taking a complicated approach using multiple medications to address schizoaffective disorder symptoms because widely accepted guidelines for the treatment of the condition are not available. The approval of an effective once-monthly medication that can be used as monotherapy or adjunctive therapy to manage the symptoms associated with schizoaffective disorder has the potential to change that approach," said Mr David P Walling, study lead investigator and chief executive and clinical officer, Collaborative NeuroScience Network. ]]> <![CDATA[Bengaluru to get Asia's first science gallery]]> https://biospectrumindia.com/reports-white-papers/95/5692/bengaluru-to-get-asias-first-science-gallery.html https://biospectrumindia.com/reports-white-papers/95/5692/bengaluru-to-get-asias-first-science-gallery.html Tue, 18 Nov 2014 12:43:32 +0530 Bengaluru will be the first Asian city to house a science gallery, designed on the model pioneered at Trinity College Dublin, Ireland's leading research university. A Memorandum of Agreement (MoA) to the effect was recently signed by the Science Gallery International (SGI) and the Karnataka State Government. The gallery is expected to hold innovative and ever-changing science programs and showcase new innovations and developments in science. The MoA was signed by Mr Srivatsa Krishna, IAS, secretary to Government, department of IT, BT, S&T, Karnataka and Dr Chris Horn, the chairman of SGI. The event also saw participation of eminent delegates from the Indian government like Mr SR Patil, minister IT, BT, S&T and the Irish minister Mr Damien English and the CEO of SGI, Dr Micheal John Gorman. The gallery will be a major flagship project to enhance public engagement with science. The gallery will be housed at the Indian Institute of Science, Bengaluru. An estimated investment of Rs 25 crores is targeted towards setting up the gallery which is expected to be open by 2018 and welcome 4, 00,000 visitors every year. In his opening speech, Mr Srivatsa Krishna, said, "The gallery will provide enormous opportunities to engage the youth with the world of science and innovation and keep them abreast of today's scientific issues and help in unraveling the new discoveries in the field of science." Mr SR Patil called the initiative a step in the right direction to solve global scientific challenges. Speaking at the event Mr Patil added, "The lead academic partner will be the Indian Institute of Science with collaborating academic partners like the National Center for Biological sciences and the Shristi School of Art, Design and Technology." Prof. Anurag Kumar, director, IISc, said, "The science gallery will help in showcasing Indian research at a global stage. The gallery will help in spreading scientific temperament in the youth." SGI has planned to set up eight science galleries across the globe by 2020. The Global Science Gallery has received funding support from Google and the Cordover family Foundation. ]]> <![CDATA['Cancer care in India needs urgent attention']]> https://biospectrumindia.com/reports-white-papers/95/4663/cancer-care-in-india-needs-urgent-attention.html https://biospectrumindia.com/reports-white-papers/95/4663/cancer-care-in-india-needs-urgent-attention.html Tue, 18 Nov 2014 12:34:12 +0530 Recently Aster Medcity, Kochi, hosted an international Cancer Conclave in its campus, called the 'Horizons in Cancer Care.' The Conclave aimed at exploring new horizons and trends for cancer management in India. The event was attended by over 150 national and international delegates from the medical community, who explored the latest developments and technological innovations in cancer care. The event, held on November 09, 2014, was spearheaded by Dr MV Pillai, chairperson of Aster Medcity oncology center and Dr Harish Pillai, CEO, Aster Medcity. The conclave served as a platform to analyze the demographics of cancer care in India and deliberated on harnessing treatment resources and economics in treating cancer. The experts also analyzed the cancer burden in the country and various advances in medical oncology that can help improvise cancer management. Speaking at the event, Dr Azad Moopen, chairman, Aster DM Healthcare, said, "Millions of new cancer cases are diagnosed every year in India. The number of deaths due to cancer is expected to rise to 1.2 million every year by 2035. Through Aster Medcity we will provide best-in-class treatment to our cancer patients." Dr Robert Gallo, co-discoverer of HIV and founder of the institute of Human Virology, explained about the unique Global Virus Network formed under his directorship to bolster viral epidemic surveillance and research. He highlighted that viral infection was also a major cause of cancer development and urged global virologists to utilize the GVN platform and address the medical challenges posed by viruses. Under the guidance of Tata Memorial Hospital, Mumbai, a National Cancer Grid has been formed, funded by the government of India. The grid collaborates a network of 52 top cancer centers in India, to build cancer awareness, research and training. Explaining the initiative, Dr CS Pramesh, oncosurgeon, Tata Memorial Hospital, Mumbai, mentioned, "The cancer grid will help in bringing in cancer treatments to the remote parts of the country that still lack in basic cancer screening facilities. Through our initiative we are planning to provide cancer care to millions of people in North and East India where cancer mortality is very high." Dr Harish Pillai, CEO, Aster Medcity, said, "Awareness of cancer in India is very low. This conclave aims at highlighting the need of cancer registry in India that helps track cancer incidents and the respective developments. At Aster Medcity, we are announcing an unique Oncology Center of Excellence that will help in bringing in latest advancements and treatments in cancer detection and cure." With the number of cases soaring, experts urged that cancer care in India needed immediate attention. The delegates also highlighted the importance of public-private partnerships for nurturing cancer innovations in the country. Many oncology experts also pointed out the lack of early detection and screening facilities in North and East India that led to high mortality rates in cancer. ]]> <![CDATA[NCDs account for 53% deaths in India : White Paper]]> https://biospectrumindia.com/news/95/4521/ncds-account-for-53-deaths-in-india-white-paper.html https://biospectrumindia.com/news/95/4521/ncds-account-for-53-deaths-in-india-white-paper.html Tue, 18 Nov 2014 10:21:00 +0530 Non-Communicable diseases are anticipated to adversely impact the economy to the extent of 230 billion INR. Overall, it is important to note that in a deacde, non-communicable diseases are the leading cause of mortality and responsible for 63 percent deaths worldwide. While in India NCDs accounts for 53 percent of deaths. According to PwC NATHEALTH (Healthcare Federation Of India) White Paper, based on available evidences, the non communicable diseases prevalence in India includes 30 percent Cardiovascular diseases; Stroke 16 percent; Malignant Neoplasm 12 percent; Chronic Respiratory diseases and Asthma 22 percent; Digestive diseases 9 percent; Diabetes Mellitus/Endocrine Disorders 4 percent and Genitourinary diseases consitute 4 percent. Currently, there is talk about developing a common framework for the NCD policy in consensus with PSEs and other stakeholders. However, there is no susbtantial work happening as the focus is more on communicable diseases, due to higher risks and fear of lesser preventive measures. ]]> <![CDATA[Modi's Australia Visit: Big focus on R&D in agribiotech, biofuels]]> https://biospectrumindia.com/news/95/5637/modis-australia-visit-big-focus-on-rd-in-agribiotech-biofuels.html https://biospectrumindia.com/news/95/5637/modis-australia-visit-big-focus-on-rd-in-agribiotech-biofuels.html Mon, 17 Nov 2014 14:37:00 +0530 There must have been many Indian prime ministers who have visited Australia before. But this one by the current prime minister, Narendra Modi is surely a unique one, given the fact that from day one the focus was on research and development in agriculture. "PM @narendramodi 1st engagement in Brisbane focussed on projects of bio-fuels, bio-fortification and agro-robotics," stated the ministry of external affairs spokesperson, Mr Syed Akbaruuddin. "Research is the mother of development," wrote PM Modi later in his message on the Agro-robot at Queensland University of Technology (QUT). Later in his speech at QUT, the prime minister stated, "Let us foster closer cooperation in skill development and education; and, research and development. Your Universities and Research Institutions have already contributed significantly to the growing science and technology relationship between India and Australia. This is particularly true for the collaboration between the two countries under the Australia-India Strategic Research Fund." "I know that most of you are aware of the opportunities in India and have looked at the market. You will begin to find a difference in India. They will no longer have to reach those opportunities through uncertain and unpredictable pathways, crossing hurdles along the way. You will not only be able to convert opportunities into partnerships, you will do it in an environment that is welcoming and easy to do business in," said Modi. It will be interesting to know what the plan of action will be by the Modi government on the biotechnology regulations bill that is pending, besides the genetically modified crops, in the next few months. Whether or not the prime minister overrules the objections, will be closely watched as he is percieved to be technology supporter and business friendly in his approach. ]]> <![CDATA[Roche to support start-ups]]> https://biospectrumindia.com/news/95/4907/roche-to-support-start-ups.html https://biospectrumindia.com/news/95/4907/roche-to-support-start-ups.html Mon, 17 Nov 2014 13:57:14 +0530 LabCentral and Roche have announced an agreement in which Roche would provide technology and financial support to LabCentral, a first-of-its-kind shared laboratory space designed as a launchpad for high-potential lifesciences and biotech startups. "We are thrilled to welcome Roche as our newest gold sponsor. Having the world's largest biotech company on our roster of supporters is a testament to LabCentral's model designed to spur science innovation and fast-track startups to be successful and improve human health," said Mr Johannes Fruehauf, co-founder and president, LabCentral. "Translating lifescience research into improved ways to diagnose disease is critical to the development of personalised healthcare solutions and better patient care. LabCentral and its resident companies are at the center of some of the most-promising healthcare research, and Roche is excited to be a part of their effort to foster this kind of innovation," said Roche diagnostics North America president and CEO, Mr Jack Phillips. Roche instruments will expand capacity for LabCentral resident companies performing high-throughput DNA studies. They include a MagNA Pure 96 robotic workstation for automated purification of nucleic acids, LightCycler 96 Real-Time PCR system, and automated reagent freezer. ]]> <![CDATA[US FDA accepts Actavis' New NDA]]> https://biospectrumindia.com/news/95/4532/us-fda-accepts-actavis-new-nda.html https://biospectrumindia.com/news/95/4532/us-fda-accepts-actavis-new-nda.html Mon, 17 Nov 2014 13:48:40 +0530 The US Food and Drug Administration (US FDA) has accepted Actavis' Supplemental New Drug Application (sNDA) for Saphris (asenapine) for the acute treatment of manic or mixed episodes associated with bipolar I disorder in paediatric patients aged 10 to 17 years. The company's sNDA for Saphris has been granted priority review status by the FDA. "The sNDA filing of Saphris speaks to our commitment to ongoing research and development of our mental health portfolio. We are pleased that the FDA has accepted this sNDA, marking the first step towards our goal of bringing this important antipsychotic treatment option to paediatric patients,"said Mr C David Nicholson, senior vice president, Actavis Global Brands R&D. The sNDA submission for asenapine is based on the results of a three-week monotherapy trial in 403 paediatric patients (10 to 17 years of age), of whom 302 received asenapine. In the trial, asenapine was shown to be statistically superior to placebo in the reductions of both the Young Mania Rating Scale (YMRS) total score and Clinical Global Impression-Bipolar (CGI-BP) score at fixed doses of 2.5 mg, 5 mg and 10 mg twice daily. The most commonly observed adverse reactions (incidence = 5 per cent and at least twice that for placebo) were somnolence, dizziness, dysgeusia, oral hypoesthesia, oral paresthesia, nausea, increased appetite, fatigue and increased weight. SAPHRIS is indicated for the treatment of schizophrenia in adults, and for the acute treatment of manic or mixed episodes associated with bipolar I disorder in adults, as monotherapy or as adjunctive therapy with either lithium or valproate. ]]> <![CDATA[Gilead shows the way with Sovaldi generics]]> https://biospectrumindia.com/views/95/4490/gilead-shows-the-way-with-sovaldi-generics.html https://biospectrumindia.com/views/95/4490/gilead-shows-the-way-with-sovaldi-generics.html Mon, 17 Nov 2014 12:13:00 +0530 India's generics pharmaceutical industry got a major recognition and boostrecently when Gilead Sciences decided to licence manufacturing of its bestselling Hepatits C drug Sovladi to seven Indian companies. Sovaldi, approvedonly last December, is already on track to be a blockbuster drug with salesexpected to cross $11 billion in its first year in the market.Sovaldi became controversial when its 12-week course was priced at a whopping$84,000 or about $1,000 (Rs 60,000) per tablet. With more than half the world'sHepatitis infections reported from India and 90 other countries, generics companies here would have definitely sought compulsory licensing rights in the near future. So it was smart on the part of Gilead Sciences, based in California, USA, to licence production of Sovaldi to seven Indian companies - Ranbaxy Laboratories, Cipla, Cadila Healthcare, Hetero Drugs, Sequent Scientific and Mylan Laboratories.Significantly, Gilead did not set any price for the products to be sold by these Indian companies not just in their home country but also in 91 other countries where they were allowed to sell the product. These companies are expected to start selling Sovaldi by mid-2015. In fact, Gilead expects these companies to set the benchmark for the generics version Sovaldi. Gilead will earn royalty on Sovaldi sales by these companies.India's biotech company leaders are highly appreciative of this step by Sovaldi. It has increased the profile of Indian biogenerics makers and demonstrated their capabilities. This is certainly a welcome recognition for India's generic drug makers at a time when the quality of some of its products sold in global markets have been questioned by a US-Canada joint study. In September, a study released by American Enterprise funded by Legatum Institute and the Human Research Council of Canada blasted the low quality of two antibiotics and two anti-TB drugs sold mostly in Africa by 14 Indian generics companies. The study authored by Dr Roger Bate, along with Dr Amir Attaran, Ms Ginger Zhe Jin and Ms Aparna Mathur has made considerable waves across the world. They studied more than 1,400 samples of these drugs collected from various parts of Africa. About 9 percent of these samples were found to have lower quality of the active ingredients than indicated. Thus these drugs would be less effective when administered to patients. And only recently, Ranbaxy Laboratories and Sun Pharmaceuticals have faced US regulator's censure for the poor quality of drugs produced by these companies at some of their plants for supply in the US. As India's generics drug industry gains more global attention for their prowess, the scrutiny is also bound to increase proportionately. This is a warning sign Indian drug manufacturers should not ignore.There is another interesting issue related to Sovaldi which indicates the highly unusual dynamics of the global drug markets for innovators. Any company which earns $11 billion with a new drug in the first year should be very happy. But analysts point out that Sovaldi's sales has already started to slow down below $3 billion in the third quarter from a high of $3.5 billion in the second quarter. Gilead's stocks have been hammered for this in the market. ]]> <![CDATA[Medtronic tie-up with CARE hospitals]]> https://biospectrumindia.com/news/95/4479/medtronic-tie-up-with-care-hospitals.html https://biospectrumindia.com/news/95/4479/medtronic-tie-up-with-care-hospitals.html Mon, 17 Nov 2014 12:12:15 +0530 Medtronic has announced a strategic partnership with CARE Hospitals to set up Heart Failure (HF) clinics for the prevention and management of Congestive Heart Failure (CHF). The first HF Clinic will be launched in Hyderabad. "The increasing burden of heart failure is a serious cause of concern all over the world, especially in India. Our PANARrhythMia and Heart Failure Registry (PANARM HF) also showed that the disease onset of HF patients in India begins a decade earlier than in Western patients, underlying the urgency of providing timely and effective treatment," said Mr Milind Shah, vice president South Asia, managing director, Medtronic India. The HF clinics will be set up by Medtronic Healthcare Solutions and CARE Hospitals to provide integrated care in a patient-focused environment for the diagnosis, treatment, and management of HF. A key focus area would be the education of patients, families, members of the community, and healthcare professionals on HF management. According to Mr Dilip Jose, CEO, CARE Hospitals Group, said, "CARE Hospitals is recognised for its advanced, complete cardiac care, powered by cross-functional teams. This partnership with Medtronic, a world leader in heart failure treatment solutions, would further enhance our comprehensive patient-focussed cardiac care and commitment to treating HF. We continue to deliver cutting-edge solutions to tackle the rising burden of heart disease in India and the HF Clinics underline our focus on preventing and curbing the effects of the disease." ]]> <![CDATA[Keep walking, stay fit says the health Minister]]> https://biospectrumindia.com/news/95/4239/keep-walking-stay-fit-says-the-health-minister.html https://biospectrumindia.com/news/95/4239/keep-walking-stay-fit-says-the-health-minister.html Sat, 15 Nov 2014 10:39:00 +0530 The Union Health Minister Mr Harsh Vardhan has urged citizens to prioritize health and introduce simple exercises like walking to improve lifestyle and healthcare, thus reducing the disease burden of the society. Flagging off a Max Bupa Walk for Health event held in the national capital, Delhi, the Minister said, "I will be very happy if I can make all the 122 crore Indians walk at least half an hour every day." Max Bupa Walk for Health is a joint initiative by Max and Bupa, which has been educating families about the benefits of walking to bring about a positive and long-term sustainable behavioral change in their health and overall well-being. Dr Vardhan said, "Walking, playing sports, eating nutritious food and saying no to tobacco and alcohol can cut down risk of all the major killer diseases, such as heart attacks, stroke, diabetes and cancers. Walking is the easiest exercise that can keep one healthy." He further stated that we need to focus on integration of all systems of medicine to not just treat but also manage and prevent illnesses. The country's healthcare coverage can be improved if we modernize and use the existing infrastructure in an optimal manner, ensure there is no staff, medicines or equipment shortages. ]]> <![CDATA[A virus that can make you stupid!]]> https://biospectrumindia.com/news/95/4109/a-virus-that-can-make-you-stupid.html https://biospectrumindia.com/news/95/4109/a-virus-that-can-make-you-stupid.html Sat, 15 Nov 2014 10:36:00 +0530 Researchers from the Johns Hopkins School of Medicine and the University of Nebraska, have identified a new algal virus known as ATCV-1 from throat swabs of healthy volunteers. This virus is found to impair mental thinking capacity, brain activity, learning and memory, thus making one 'stupid'. Reportedly, the chance discovery happened when the scientists were conducting a study on throat microbes. The team led by Dr Robert Yolken said the virus was completely new and after various database checks, it was found to lessen mental capacity. Typically, ATCV-1 infects a species of green algae found in lakes and rivers, and has not previously been known to infect humans. However, when Dr Yolken's team had conducted a screening of a group of 92 healthy volunteers to evaluate cognitive function, the virus was found to be present in 43.5 percent of them. Further study conducted on the volunteers found that 10 percent of the people performed worst on tests analyzing visual processing speeds. Researchers also found that the presence of the virus was linked to lower attention spans and decreased spatial awareness, and a "statistically significant decrease in the performance on cognitive assessments of visual processing and visual motor speed." Research in animals also echoed the human findings as the infected animals took 10 percent longer to find their way out of mazes and spent 20 percent less time exploring new objects than uninfected mice. The team also said that though the virus appeared to be non-contagious, further research was needed to determine how the virus was present in such large abundance in the population. ]]> <![CDATA[Major higher management revamp at Fortis]]> https://biospectrumindia.com/news/95/4210/major-higher-management-revamp-at-fortis.html https://biospectrumindia.com/news/95/4210/major-higher-management-revamp-at-fortis.html Fri, 14 Nov 2014 15:40:58 +0530 With its major international divestments successfully completed, Fortis Healthcare has now firmly strengthened its strategic focus on India. Mr Aditya Vij, the CEO since mid-2011, will be transitioning from Fortis by the end of the year, to pursue his family business and investments, as he sets a future professional agenda for himself, aspects he has been desirous of concentrating on for some time now. Outgoing chief executive officer, Mr Aditya Vij said, "The company is on a strong footing. With Fortis' eminent doctors and key executives in focal positions of responsibility I feel confident that the company's future is in good hands. My personal commitments at this juncture require me to concentrate on my family business and investments, as I set a future professional agenda. I will be relinquishing my role with a sense of accomplishment and wish the entire Fortis Team, all success." Acknowledging and taking on record Mr Aditya Vij's contribution to the company, Mr Malvinder M Singh, executive chairman and Mr Shivinder Singh, executive vice chairman, said, "In his tenure during the last three years, Aditya has led the team with maturity whilst driving the company's performance agenda, putting it into its next phase of growth. He facilitated the smooth integration of the acquired Wockhardt hospitals and heightened the sensitivity of the operations team towards patient centric care and medical excellence. We wish Aditya the very best for the future." Post international divestments, Fortis is also realigning its talent to further consolidate and grow its business. In recent months, it has structured the company to meet the country's emergent challenges whilst improving organizational efficiency and effectiveness. The company has used a judicious mix of in house succession and the selective external infusion of experienced professionals to add to its delivery capability. With the business now on a stable footing, Mr Balinder Dhillon, president, Corporate Governance, is being elevated to promoter f Group office of RHC Holdings (RHC) where his vast skill set and experience will be available to the entire group. RHC is the holding, investment, and financial advisory company of the promoter group, with a portfolio of 5 listed businesses that include Fortis. Mr Dhillon will assume his new role as Group President - Corporate Governance - RHC Holdings from April 1, 2015. Congratulating Mr Dhillon, on his elevation, Messrs Malvinder and Shivinder Singh said, "We value Dhillon's numerous contributions, strategic counsel and insightful advice to the company. He has been a longstanding and invaluable member of our Apex leadership team that has successfully spearheaded the international acquisitions and divestments for the Company. Dhillon has set up and institutionalised the professional governance framework within Fortis, leading the Audit, Risk, Legal and Secretarial functions. He has raised the bar to an entirely new level putting in place robust risk assessment and audit mechanisms. We look forward to working with him as he takes on his additional responsibilities in creating a strong governance edifice for the group." Fortis in recent months has also structured the company for greater success, creating and assigning roles and responsibilities to augment and drive patient centric measures for improved clinical outcomes as well as for greater efficiency and organizational excellence. The company has positioned many of its experienced executives in strategic roles and infused fresh talent in medical operations, Training and Development, Sales and Marketing, to bring about greater alignment and traction in its ability to serve its customers better. Significant changes that have been made include Mr Gagandeep Singh Bedi's recent appointment as CFO. Mr Bedi is a qualified chartered accountant with a long international track record at Philips and the past over 3 years with Fortis, as head of Global Supply Chain and Shared Services. Ms Sandra Subner has joined the company as head of Medical Programme Management. Ms Subner brings to Fortis over 26 years of experience in the healthcare industry, across the world, in venerable institutions such as the Islington Health Authority, The Camden London, The Singapore General Hospital, Singapore, among others. Air Marshal Dr B Keshav Rao (Retd) has joined Fortis as regional medical director for Delhi/NCR. Dr Rao is a seasoned medical professional with over three decades of experience in the Armed Forces. Prior to Joining Fortis, he was the director and commandant of the prestigious AFMC, Pune. Commander (Retd) Dr Kamal Cheema, with over three decades of experience, most of which has been with the Armed Forces in positions of great responsibility, joined Fortis recently, as regional medical director, West and East Regions. Major General (Retd) Dr Yash Pandey, has joined the prestigious Fortis Escorts Heart Institute, New Delhi, as its Medical Director. Dr Pandey was formerly the Additional Director General of the Armed Forces Medical Services and was responsible for the recruitment of top flight medical doctors into the three services. Mr. Raj Gore, who has handled varied assignments within Fortis, including international operations in Mauritius and in Vietnam, has returned to India and has been inducted as Vice President - Operations, to lead the Company's performance enhancement initiatives. With these augmenting steps and its vast talent pool of existing medical and management professionals, Fortis is well positioned to leverage its expertise to address and capitalise on its current and emergent priorities in the fast evolving healthcare landscape. ]]> <![CDATA[Elimination of Rubella, Measles possible by 2020: WHO ]]> https://biospectrumindia.com/news/95/4200/elimination-of-rubella-measles-possible-by-2020-who-.html https://biospectrumindia.com/news/95/4200/elimination-of-rubella-measles-possible-by-2020-who-.html Fri, 14 Nov 2014 15:18:18 +0530 "WHO's Southeast Asia region is committed to the elimination of measles and control of rubella/congenital rubella syndrome by 2020. Countries are scaling up efforts to protect children against these deadly diseases by targeting 95 percent coverage with each of the two doses of measles vaccines and rubella containing vaccine to the childhood immunization schedule," mentioned Dr Poonam Khetrapal Singh, WHO Regional Director for Southeast Asia Region on the release of the report on measles on November, 14. WHO is supporting the member states to develop robust national plans for measles elimination and rubella control. Efforts are focused on building a sensitive and timely standardized laboratory supported case-based surveillance for measles and rubella for which laboratory networks are being expanded and their capacities enhanced. The Region has a mix of success stories and challenges. Dr Khetarpal stated further,"Four of the eleven countries - Bhutan, Democratic People's Republic of Korea, Maldives, and Sri Lanka - are likely to have eliminated measles, which will need to be verified. At the same time, the Region still accounts for nearly one-third of the children who have no protection against measles. While the progress gives us confidence, the challenges are a reminder that we need to do more. The disease is highly contagious and can cause serious complications including blindness, encephalitis, severe diarrhoea, ear infection, and pneumonia, particularly in malnourished children and people with reduced immunity. We know measles can be prevented with immunization. We must protect our children with measles and rubella-containing vaccines." ]]> <![CDATA[Prof Shubha Tole wins Infosys Prize 2014 in Life Sciences]]> https://biospectrumindia.com/news/95/5157/prof-shubha-tole-wins-infosys-prize-2014-in-life-sciences.html https://biospectrumindia.com/news/95/5157/prof-shubha-tole-wins-infosys-prize-2014-in-life-sciences.html Thu, 13 Nov 2014 17:08:03 +0530 This year, in the Life Sciences category, the award has been given to Prof Shubha Tole, who is an associate professor and principal investigator in the department of biological sciences, at the Tata Institute of Fundamental Research (TIFR), in Mumbai. It was cited that she had made significant contributions in understanding how the brain structure and circuitry are formed in the embryo, leading to better understanding of human behavior, cognition and emotions. Now in its 6th year, the Infosys Prize is given to high caliber researchers for their impactful contribution in their respective fields. The prize consists of Rs 55 lakh, which is tax-free for winners receiving within India; a 22-karat medallion; and a citation certificate. The awarding ceremony will happen in Kolkata on January 5, 2015, and the awards will be presented by the Indian President, Shri Pranab Mukherjee. The Infosys Science Foundation, erected in 2009, is funded by a corpus which stands at Rs 100 crore, contributed by the trustees and Infosys. In 2013, Dr Rajesh S Gokhale, director, CSIR-Institute of Genomics and Integrative Biology, won the award for his work in the field of lipid metabolism in M. tuberculosis The other 5 winners for 2014 include: Engineering and Computer ScienceProf Jayant HaritsaProfessor, Supercomputer Education and Research Centre (SERC) and Chair, Department of Computer Science and Automation (CSA), Indian Institute of Science (IISc), Bangalore, India Prof Jayant Haritsa has been awarded this prize for his contributions to the design and optimization of database engines. HumanitiesProf Shamnad BasheerFounder and Managing Trustee, Increasing Diversity by Increasing Access (IDIA), Bangalore and Founder - SpicyIP, India Prof Shamnad Basheer has been awarded this prize for his contributions to the analysis of a range of legal issues, including pharmaceutical patent injunctions and enforcement. Mathematical SciencesProf Madhu SudanPrincipal Researcher, Microsoft Research New England and Adjunct Professor, Electrical Engineering & Computer Science (EECS) department and Computer Science and Artificial Intelligence Laboratory (CSAIL), Massachusetts Institute of Technology (MIT) Prof Madhu Sudan has been awarded this prize for his seminal contributions to probabilistically checkable proofs and error-correcting codes. Physical SciencesDr Srivari ChandrasekharScientist G, Organic Chemistry Division, Council of Scientific and Industrial Research, Indian Institute of Chemical Technology (CSIR-IICT), Hyderabad, India Dr Srivari Chandrasekhar has been awarded this prize for his contributions in the general area of synthetic organic chemistry with a special focus on the synthesis of complex molecules from natural sources. Social SciencesProf Esther DufloAbdul Latif Jameel Professor of Poverty Alleviation and Development Economics, Department of Economics, Massachusetts Institute of Technology (MIT) and Founder & Director, Abdul Latif Jameel Poverty Action Lab (J-PAL), USA Prof Esther Duflo has been awarded this prize for her pioneering contributions to development economics, especially work related to countries such as India and Africa. ]]> <![CDATA[Govt proposes innovation fund for MSMEs]]> https://biospectrumindia.com/news/95/5302/govt-proposes-innovation-fund-for-msmes.html https://biospectrumindia.com/news/95/5302/govt-proposes-innovation-fund-for-msmes.html Thu, 13 Nov 2014 12:45:00 +0530 The government proposes to launch an innovation fund exclusively for Micro, Small and Medium Enterprises (MSMEs) to encourage and promote new knowledge-driven ventures and programs, revealed Mr Kalraj Mishra, minister of micro, small and medium enterprises, Government of India, while inaugurating the two-day 'Global R&D Summit 2014' on the theme 'Next Gen Innovations through Interdisciplinary Research'. Adding further, the minister said that the new Sfurti scheme launched by his ministry has helped in providing start-up funds for small and new ventures. This was in keeping with the government's desire to promote innovation in industry and make India a global R&D hub in the coming years. The well-attended two day event attracted a huge number of experts from industry and academia. An exbibhition to showcase research efforts was also inaugurated during the day. The minister said the micro, small and medium enterprises contribute nearly 8 percent of the country's GDP, 45 percent of the manufacturing output and 40 percent of the exports. "They provide the largest share of employment after agriculture. They are the nurseries for entrepreneurship and innovation. He said the Ministry has a number of programs to help and assist the entrepreneurs and small businesses," said Mr Mishra. Mr George Sibley, counselor for economic affairs and environment, science and technology, The US Embassy, India, stated that R&D is envisioning the new products that the market would need and innovate and develop such products. He said that the technological advancements have helped in averting mass destruction during floods and droughts as well. But the advancements has led to climate change and there was a need to re-double efforts to prevent the environment from any more harm. There would be a demand for low cost renewables and technology that manages global warming better and this required a thrust in R&D. Dr Sarjerao Bhaurao Nimse, general president, Indian Science Congress Association, said that the scientific community needs to support the Prime Minister's ambitious vision of 'Make in India'. Earlier, not much importance was given to R&D but now the stress is on developing innovative technologies. There was an immediate need to invest in research to develop knowledge and this knowledge must be converted into patents so that the investment is able to generate revenue. Industry, he said, must support laboratories and fund the R&D programs. The session moderator Mr Shalendra Porwal, co-chairman, FICCI S&T/Innovation Committee and managing director and CEO, Battelle Science and Technology India, urged the minister to continue initiatives as the Innovation Fund as the R&D sector lacked finance and was in dire need large amount of investment. While presenting the concluding remarks and vote of thanks, Dr Makarand Phadke, Chairman, FICCI National Committee on S&T/Innovation and Sr. VP-Innovations, Reliance Industries, said that it was time for convergence of diverse and inter-dependent ideas to develop novel products and services to further the technological advancement in the country. ]]> <![CDATA[India, UK sign agreements, creation of Newton-Babha fund announced]]> https://biospectrumindia.com/news/95/3984/india-uk-sign-agreements-creation-of-newton-babha-fund-announced.html https://biospectrumindia.com/news/95/3984/india-uk-sign-agreements-creation-of-newton-babha-fund-announced.html Thu, 13 Nov 2014 11:44:02 +0530 In a meeting held between Dr Harsh Vardhan, minister for science and technology and the UK's minister for universities, science and cities the Rt Hon Greg Clark MP held here in New Delhi on November 12, 2014, it was decided that a new fund known as the Newton-Bhabha Fund will be taken to further relations. This was the 4th UK-India Science and Innovation Council (SIC) meeting held at New Delhi, which was Co-Chaired by both the science ministers. They applauded the significant role that the UK-India research and innovation partnership has played in bringing together the best researchers in both countries. The countries are actively cooperating to address global challenges through the application of science and technology. The two Ministers noted that the UK-India Education and Research Initiative (UKIERI) has been successful in building new scientific partnerships through joint research projects and networking. It was agreed in principle to augment and continue UKIERI Phase III. The Newton-Bhabha Fund (£50 million over 5 years from the UK and matched efforts from India) is an important program, with a strong interdisciplinary dimension that will further strategize the science, research and innovation cooperation between the UK and India. A series of new Newton-Bhabha programs were welcomed, including : 1. British Council India and the Department of Science and Technology, India joint PhD student mobility program. This will sponsor UK and Indian PhD students to spend a period of their study (3 to 6 months) in premier Indian and UK higher education institutions starting from March 2015. The aim of the program is to pave the way for the next generation of researchers in the UK and India to interact with each other and build long-term R&D linkages and collaborations. 2. The UK's Medical Research Council (MRC) and Indian Council of Medical Research (ICMR) joint initiative for new research projects in Mental Health and Substance Abuse. Up to £2 million is available from the UK and ICMR will fund the Indian component.3. Up to £10 million for joint Global Research Program in Women's and Children's Health funded by the UK's Medical Research Council (MRC), Department of International Development (DFID) and India's Department of Biotechnology (DBT) 4. Up to £7 million for Joint Centre Partnerships in Cancer Biology, Translational Regenerative Medicines in Neuroscience and Antimicrobial Resistance, funded by UK's Medical Research Council (MRC) and India's Department of Biotechnology (DBT).5. Joint UK-India centre(s) for research in Renewable Energy co-funded by RCUK Energy program and India's Department of Science and Technology (DST). 6. Innovate UK and the Department of Science & Technology, India joint program to support business-led research and development aimed at tackling grand societal challenges. ]]> <![CDATA[Venus Remedies strengthens portfolio in Swiss market ]]> https://biospectrumindia.com/news/95/7634/venus-remedies-strengthens-portfolio-in-swiss-market-.html https://biospectrumindia.com/news/95/7634/venus-remedies-strengthens-portfolio-in-swiss-market-.html Thu, 13 Nov 2014 11:39:10 +0530 "With plans to launch this product early next year through our partner Swiss Pharma GmbH Zurich, we will be able to capture 10 percent share in the meropenem market of Switzerland," said chairman and managing director of Venus Remedies, Mr Pawan Chaudhary. Being among the first few companies to receive marketing authorization from Switzerland for this drug, Venus enjoys a distinct advantage. "The marketing approval for this critically important antibiotic has once again proved the company's R&D capabilities and its expertise in developing world-class products with regulatory might. It will help us strengthen our portfolio in the Swiss market," added Mr Chaudhary further. The global annual sale of meropenem, which stood at $1,879 million in 2012, is estimated to grow at a compounded annual growth rate of 7.5 per cent to reach around $2,100 million in 2014-15. The drug is used in the treatment of severe bacterial infections like pneumonia, broncho-pulmonary infections in cystic fibrosis, complicated urinary tract infections, complicated intra-abdominal infections, intra and post-partum infections, complicated skin and soft tissue infections and acute bacterial meningitis. Venus Remedies has secured more than 40 marketing authorizations for meropenem throughout the world from countries like the UK, France, Germany, Saudi Arabia, Australia, and Italy, among others. With this marketing approval from Switzerland, the company is expecting to generate good revenue in the coming year. Venus is already selling meropenem in various European Union (EU) and non-EU markets, and is in the process of extending its footprint and sales operations in other markets like Spain, Australia, and South Africa through strategic tie-ups. ]]> <![CDATA[Merck publishes its Hepatitis C drug trial data ]]> https://biospectrumindia.com/news/95/3969/merck-publishes-its-hepatitis-c-drug-trial-data-.html https://biospectrumindia.com/news/95/3969/merck-publishes-its-hepatitis-c-drug-trial-data-.html Thu, 13 Nov 2014 09:50:00 +0530 Grazoprevir/elbasvir is the company's investigational NS3/4A protease inhibitor and NS5A inhibitor, in combination with sofosbuvir, a nucleotide (NS5B) inhibitor for the treatment of chronic hepatitis C virus (HCV) infection. Preliminary findings will be presented by Dr Eric Lawitz, vice president, scientific and research development, The Texas Liver Institute, Texas, USA, and C-SWIFT's lead investigator. "Our goal is to establish a simple, effective, well-tolerated regimen that is applicable across the diverse population of patients with HCV," said Dr. Eliav Barr, vice president, infectious diseases, Merck Research Laboratories. "The preliminary data provide us with the confidence to initiate our C-CREST study to evaluate a triple combination comprising Merck's investigational candidates from three major therapeutic classes of HCV medicines." "These interim data provide a compelling proof-of-concept for the potential of an eight- or six-week triple therapy course in treatment-naive patients with genotype 1 disease, including cirrhotic patients," said Dr Eric Lawitz. "These findings will inform the design of larger studies aimed at understanding the potential of short-duration triple therapy across multiple patient types." ]]> <![CDATA["Sustainability is part of all our projects"]]> https://biospectrumindia.com/interviews/95/4520/sustainability-is-part-of-all-our-projects.html https://biospectrumindia.com/interviews/95/4520/sustainability-is-part-of-all-our-projects.html Wed, 12 Nov 2014 12:41:02 +0530 The study was conducted by TNS Global. This study is the third in its series following studies in North America (USA and Canada) and China. The study was conducted across 12 cities in India and highlights interesting trends especially in comparison with China and other countries. On the sidelines of the launch of this report on India's confidence in green and bio-based products, recently in Hyderabad, Mr Balvinder Singh Kalsi, president, DuPont South Asia and ASEAN and Mr Vikram Prabhu, regional business director, Asia Pacific, DuPont Industrial Biosciences shared their thoughts with BioSpectrum on the role of sustainability and DuPont's Industrial biosciences thrust. This is a fairly new market for the company. It forms one of the three pillars on which DuPont operates, the others being agriscience and advanced materials. Excerpts: What do you think of the industrial bioscience market in India? How does it compare with the rest of Asia?Mr Vikram Prabhu: Industrial biosciences, frankly, is still a fairly young market all across the globe. India is not that far behind. We are very excited about the zero effect-zero defect campaign that the Prime Minister has launched. It is connected to industrial biosciences. It not only provides solutions of value to the customer, which are also very sustainable and good for the environment. There are some very unique aspects to India but there are some commonalities with other regions as well. It is a fascinating time. It is about getting the technology to the local customers and understanding their needs and wants. The next five years, I think will see more progress than that has been seen in the last 15 years. Part of it is timing -- the receptivity -- but there is another aspect, which has come out clearly in the survey we did with TNS. It is that the youth of India have a very high knowledge of green and bio-based products. India is a very young country as compared to US or China. We have a very young population.There is a fantastic energy and pull from them. With this kind of pull, given a choice between a traditional product and a bio-based one, they are choosing the bio-based one. The choice is clear, it is better for the environment and they don't mind paying a premium price for the same. How do you look at sustainability and does DuPont have any major projects wherein sustainability plays a major role? Mr Kalsi: Sustainability is a major part of all we do. We do not look at sustainability from a project point of view. It is just a day-to-day thing. You will find it in all the businesses we do, be it the crop care business, in which products that were used at 500 gm to a liter per acre are now being replaced by green products that can be used across eight acres. These are products that are safe for the beneficiary. They cost less and for the first time we have been given the green triangle certification. Going on to our seed business, we are working on seeds that are resistant to harsh weather conditions and those which can withstand drought conditions. We have a knowledge center here in Hyderabad. It is certified from an overall environmental aspect. For us, it is green in everything we do. Mr Prabhu: Our business is fundamentally sustainable. Every product we make has a component of sustainability. It can take different forms. We could have a product to help a customer use less water. We could have a product which enables a customer run a process to use less energy. It can have a product that allows customer create less effluents that pollute the water less. And we have products that use biobase material like starch, which is a renewable product. It reduces greenhouse gases. And so we have products going into personal care. For example, what is important here is with prolonged usage, what is the effect the products will have on the skin of a baby or the mother, especially if they contain products like mercury in them. We look at sustainability in terms of what it enables the consumers to do. What is the support from the government like? Are there any measures that need to be taken? Mr Kalsi: All of us wants the government to do much more. Take any country, we want the government to be easier, more supportive. That they understand the changing trends and some of the requirements. And the government is becoming more and more receptive to some of the things, though this varies from segment to segment and industry to industry that we operate in. In some cases, it is much more entrenched where the government understands and is supportive. In other areas there are technologies which the companies themselves are bringing in. It is an education process for all of us. You know we have to educate and pass on the knowledge and once all are on the same wavelength, it will become better and supportive. Mr Prabhu: You will see a quote in our presentation later from the Ministry of Science and Technology. We are engaged in a dialogue and it is important to understand that a decision should be science-based. The regulatory policy, over all, should reflect the desires of our people. If we look at the survey, it is very clear that to address what the society wants, needs, and desires for, we need to have a very scientific regulatory environment. We need to have a process that is clear, and this is true anywhere in the world. And we are very excited. If you look at the "Make in India" campaign, launched by the Prime Minister, biotechnology is on the list of very important industries. We are very encouraged that the current government is thinking of all the aspects and is a part of the zero effect-zero defect. If you can have that then the regulatory piece is quite easy. I am very excited about the concept. What do you think of the BRAI regulatory bill? Mr Kalsi: We will be very supportive of something like that. We have too many different agencies, departments and committees. Once you have a regulatory bill, it at least puts in a framework so we understand under which we have to work. Rules should be clearer, and everybody needs to understand what the rules are. There tends to be a lot of confusion when there are different departments, committees under the government. What are the trends in biotechnology that are worth looking out for? Mr Prabhu: In industrial biotech, there are three trends to look for. First, just the efficiency. I think in industrial biotech, it allows us the ability to bring tremendous efficiency at low costs and so also in a safe way. In general, you are replacing a chemical, a harsh process with something that is natural. Most of the enzymes, we use are things that occur naturally. Efficiency is the first key trend and it's going to be a big trend for creating value in the society. Precision is another. Enzymes are precise. They can be targeted. For example, it could be an enzyme targeting the framework of a collar. It not only makes it look good but extends the life span of a shirt. The third would be integrated science. It is about how we can enhance all the investment in science lasting hundreds of years and boost that up, for example, you go to a textile mill today; it is a very manual, laborious, and energy-intensive process. Take an enzyme and create changes between the engineering process and an enzyme between an old and new science can create a new capability. Mr Kalsi: On the broader side, for changes in the field of biotechnology, it is more about usage. Take the agriculture business for instance. Drought resistant varieties that retain moisture for a longer time and still give good yields would be beneficial. Another case could be to take agricultural waste and convert them to sugars and using enzymes turn them to polymers. Today, we have engineering polymers that go into automotive industry. They start from agricultural waste instead of petroleum products. This trend will only continue to pick up, extend into biomedical and other sectors. There is a huge amount of opportunity this side. There is a revolution sweeping the world. In a bio-based economy, how do you take biotech and natural resources and bring them into the main stream. It is not necessarily this or that. It is not about what happens if the petroleum industry does not exist anymore but more about how newer, better products can be used instead of the petroleum products. ]]> <![CDATA[Biotech Funding: What next?]]> https://biospectrumindia.com/features/95/5876/biotech-funding-what-next.html https://biospectrumindia.com/features/95/5876/biotech-funding-what-next.html Wed, 12 Nov 2014 12:41:00 +0530 There has been a lot of momentum generated since the NDA government, under Prime Minister Narendra Modi, took charge. There are some positive vibes for the biotech industry. First major announcement came from the Union Finance Minister Mr Arun Jaitley in his Budget speech in July this year. He announced the setting up of a Rs 10,000 crore fund to support start-ups and Small and Medium Enterprises (SMEs). The fund is aimed to catalyze financing in the form of equity, quasi-equity and other forms of risk capital. This is to facilitate entrepreneurs to access more risk capital and equity-based fund flow. The government also announced another fund, the "Technology Development Fund" with a corpus of Rs 100 crore. The other big impetus came to the sector, when the Prime Minister launched the Make in India campaign. Biotech and lifesciences is one of the identified segments for growth and investment. The question now is 'what next'? And how much will the biotech industry get from the Government from its proposed Rs 10,000 crore fund? Who should bid for the fund? This is one thought that has been raging the minds of investors, technologists and entrepreneurs. And there have been several on this topic at various forums like the third annual innovators meeting organized by the Biotechnology Industry Research Assistance Council (BIRAC) in New Delhi and at biotech investors meet held by ABLE in Bangalore. Most of the biotech majors in the country are asking BIRAC to play a lead role in seeking capital for the biotech industry. Simply because BIRAC has been playing a critical role for development of the sector and it is best suited to cater to the needs of the industry. According to Prof. Ashok Jhunjhunwala, Department of Electrical Engineering, IIT Madras, the venture capital today is available in the Second stage, the Third stage, and the Bridge/Pre-public stage of the financing process. The support is needed for the Seed and Start-up stage. Since the government is looking for agencies in the Seed to Start-up stage, the industry wants BIRAC to submit a proposal. BIRAC during the last three years has supported nearly 90 scientists and entrepreneurs, 240 companies, 360 projects, and 100 incubatees. It has provided support of nearly $225 million.Enabler for innovationThe critical components in a research ecosystem are industry, start-ups, and academic research institutes. Dr Kiran Mazumdar-Shaw, CMD, Biocon, cited, "It starts with the academic research institutes. It is all about the symbiotic relationship between the academia and industry. Each component rely on each other to keep building that ecosystem. Unfortunately, in India, this critical component doesn't exist. Hence most researches die away within the walls of the laboratories." The lab-to-market journey is a virtuous cycle. "Academic research is about conceptualizing new ideas and discovering new ways of doing things. This academic research is supported by public funds. For academic research to be productive, we need to get people interested in it and take the ideas to proof-of-concept (PoC) stage. This is where young start-ups have an important role to play. So this is about creating accretive value to that concept. Funding for the proof-of-concept level has to come from various funding schemes offered by BIRAC and others. It is also important to find angel investors at this stage," she explained. Post the PoC stage, the start-ups need to become a larger organization, and take it to the industry and this would need the support of venture capitalists and capital markets. "When you create this important ecosystem, then you will find industries looking out for start-ups who are creating research with interesting concepts, and thus start-ups will be able to license their IPs. Simultaneously, the academic research will start to strengthen and the whole patenting culture will kick-in and the ecosystem will become an effective ecosystem," Ms Shaw elucidated. Ms Shaw believes that if we can create a good ecosystem and build a strong path from lab-to-market, it will pave way for an exciting ecosystem. "If we want to get the government's attention in policy making, ABLE needs to write a white paper on building the ecosystem, about funding from the government, research institutes and incubators. We have to change the concept of how we access capital markets. We need to create interest among companies to take the PoC to the market funded through capital markets," commented Ms Shaw. She warned that investing in old, tried-and-tested archaic models is not going to pay any dividends. "It is going to take a long time before you see profits. If people can do it in e-tailing, why not in biotech? This is all about investment in transformational change and investment in the future. We need to inculcate this thought process among the government, investors and policy makers. Creating this ecosystem will create jobs through start-ups and take advanced scientific ideas to market. Our competitive edge is in taking advanced science at lower costs," held Ms Shaw. She defined affordable innovation as high science at lower costs in a global landscape delivered in a competitive way. "That is what India's model is about. This is what Mangalyaan was all about. And we can do that in Biotechnology (BT)," she encouraged. Funding sentimentThe economic parameters have improved. There are right messages with respect to retrospective taxes. There is VC money coming compared to growth capital. And they have been invested in technology and e-commerce space. Several schemes like those under BIRAC are assisting the early stage. But the announcement of Rs 10,000 crore is the real good news. According to MoneyTree report, Biotech investments have been soaring globally. But that has not transcended into India. It is only a matter of time before this trend trickles down to India assert investors. Mr Sujay Shetty, partner, Pharma Life Sciences Leader, PricewaterhouseCoopers, observed, "Though there is a lot of excitement, there is a lot of cautiousness too. But more success can come from companies in the biomedical and diagnostics space."Though there are concerns related to IP and drug pricing, these are not impacting the investor confidence. This has been an issue at the big pharma level but not for the investors. Things like price control are broader issues and they impact every one. It needs to be addressed in an honest manner. The industry is stifled especially on the clinical trials front and transgenics. The business of the clinical services organization has been effected. The clinical trials organizations lost 20,000 trials and $1 billion in trials. Only 15 valid trials were done in the last few months. But large clinical services companies mitigated the risk by opening offices globally. Contract manufacturing story is well set growing by 15 percent and the synthesis business is also growing. Despite these, investors are investing in biotech. Exits are happening in two ways. Secondary exits and strategic interests. Though the quantum is low. Now the capital markets have opened up. Companies are now lining up to be listed. Mr Shetty added, "There is a lot happening on the biotech talent and mobile health side. Service-led business models have been able to attract capital though most companies attract mid capital money."Should BIRAC focus on start-ups? "This is a great opportunity to tap Rs 10,000 crore and every financial institution is lobbying. As for the biotech and the lifesciences industry, there is hardly anyone who has approached the government," stated Mr Utkarsh Palnitkar, Partner & National Head - Advisory, National Head - Life Sciences practice, KPMG India. "BIRAC has a good track record as an evaluating and disbursing agency and it needs to go to the government to seek support for innovation and entrepreneurship. There several of its companies that will develop next generation drugs and drug delivery or medical devices. It will have to support them. BIRAC should look for fund managers. Another challenge is to find mentors for entrepreneurs. There is a strong case for BIRAC to pitch for the share of the fund," said Mr Nitin Deshmukh, CEO, Kotak Private Equity Group.Learning from IKP Knowledge Park's experience as an incubator and funder, one can be assured that incubation and science works. India will need 800-1,000 incubators in the next five years if Prime Minister's vision of Make in India and Entrepreneurship culture has to be realized. According Ms Deepanwita Chattopadhyay, MD & CEO, IKP Knowledge Park, any new incubator needs Rs 5 crore. There is room for 150-200 life science incubators. BIRAC alone has funded 14-15 incubators. "For 100 incubators we need about Rs 500 crore. We need another Rs 100 core for scaling up the incubators." That is the kind of funding that would be needed for the biotech sector. Ms Shaw feels that incubators needed to be created at every research institutes. "Very few research institutes have incubators in our country. If incubators do not move research ideas from concepts to PoC stage, then the virtuous cycle won't get initiated. However, once you start the cycle, the venture capitalists come on the scene and take the concept to the market," she added. The location of incubators is very crucial. Every technology institute in the country must have good incubators. Those incubators must be able to nurture start-ups and invite others as well. "It is important that we give preference to our own researchers. Many incubators in the US charge about $30 fee and let them take advantage of every part of that incubator," she revealed. Mr Shrikumar Suryanarayan, Chairman and Co-founder, Sea6 Energy, is clear that the industry is very attractive and he suggests that the industry needs to prepare a deck. "The deck should be why us? What we plan to do? What is the impact? Need to look at the mechanics of implementation. Talk about the impact of food, fuels and health needs of the world." This will give the right picture. Further, there can be investor confidence in BIRAC-certified enterprises. According to Ms Shaw another important push that would be required is on how to increase investments in revenue-less companies or loss-making companies? Investors are betting on the promise of any biotech company. How do we correct that? The investor banking company is not putting risk and the government should fund investment bankers to support the industry. What should be the way ahead?Prof. Jhunjunwala points out that BIRAC should carefully examine the partnership with VCs. They do not have the mindset for start-ups. VCs are not interested as there are many sectors and markets that have given better returns. Lifesciences industry is long gestation period. There are over 40 investments in India which have attracted between Rs 100-200 crore investment in India. Some of the non-lifesciences sectors have been able to demonstrate success. Mr Deshmukh, added, "In 2010, BSE was the first to set up SME Exchange. Nearly 66 enterprises were listed and only three were relate to lifesciences. The problem is a sponsor is needed to underwrite the issue."BIRAC has little equity experience. It will have to balance between mindshare and money. Private Equity (PE) companies invest in 8-10 companies and they give a lot of time and money one these companies. BIRAC needs resources and people to manage the funds. Mr Suryanarayan suggested, "Get mentors and incentivize the mentors. BIG has taken off and BIRAC has to create an extended enterprise."There are not enough agencies to do BIG or SIBRI. BIRAC should look for what is new that can be done with a portion of the Rs 10,000 crore pie like scaling up incubators. BIRAC does not know how to connect with PE companies and it will have to address this issue. Dr Renu Swarup, MD, BIRAC and Adviser, DBT is clear that BIRAC is not looking at scaling up BIPP, SBIRI.There is no choice, only BIRAC can make the bid. Fine print should be read to see how Rs 10,000 crore is handed - equity, debt, or grants. Whether this is to handhold entrepreneurs or invent, incubate and make an impact. Dr Swarup has acknowledged that resources, change in ecosystem and demands of innovation are indeed the cardinal challenges for BIRAC, but, she also emphasized that BIRAC should grow exponentially by designing the next five-year plan which will address the above challenges. ]]> <![CDATA[WHO urges coordinated action against antibiotic resistance]]> https://biospectrumindia.com/news/95/5406/who-urges-coordinated-action-against-antibiotic-resistance.html https://biospectrumindia.com/news/95/5406/who-urges-coordinated-action-against-antibiotic-resistance.html Wed, 12 Nov 2014 10:21:00 +0530 "We must act urgently. The world is heading for a post-antibiotic era which will be devastating in this age of emerging infectious diseases. If we do not use antibiotics rationally, we will lose the power to fight common infections and minor injuries. We need to step up efforts to prevent antimicrobial resistance and change how we prescribe and use antibiotics," said Dr Poonam Khetrapal Singh, WHO regional director for Southeast Asia, at the launch of a four-day regional meeting on antimicrobial resistance (AMR) in Jaipur. The regional meeting focuses on developing and strengthening country-level plans, building national capacities and developing mechanisms for generating information on the magnitude, trend, and the burden of AMR in Member States. WHO has prioritized AMR in view of the serious health, political, and economic implications of drug resistance. A regional strategy on prevention and containment of antimicrobial resistance was developed by WHO in 2010 which was endorsed by all Member States. The strategy focuses on improving intersectoral collaboration, strengthening regulatory mechanism for assuring quality, standardized and rational use of antibiotics, boosting national capacity for laboratory-based surveillance of AMR, reducing burden of infectious diseases, enhancing hospital infection control practices and educating and empowering communities. In 2011, the health ministers of the region made a commitment to prevent and contain AMR through the 'Jaipur Declaration'. Since the Declaration, Member States have initiated a comprehensive and integrated national approach to combat antimicrobial resistance. National focal points have been designated; multisectoral steering committees formed and national antibiotic policies are being developed in most Member States of WHO's Southeast Asia Region. Earlier this year, a WHO report flagged AMR as a big problem globally and also in WHO's Southeast Asia Region which is home to a quarter of the world's population. The report, 'Antimicrobial resistance: global report on surveillance' noted that globally, resistance is occurring across many different infectious agents, but focused on antibiotic resistance in nine different bacteria responsible for common as well as serious diseases such as bloodstream infections (sepsis), diarrhoea, pneumonia, urinary tract infections, and gonorrhoea. The results are a cause for high concern, documenting resistance to antibiotics, especially "last resort" antibiotics, in all regions of the world. The World Health Assembly has now urged WHO to develop a global action plan against AMR by 2015. The plan is being organized around five main areas of concern: awareness; information on the magnitude of the problem; economic impact; rational use of antimicrobials, and preventing infection. ]]> <![CDATA[Shantha's Pentavalent Vaccine 'Shan5' launched in India]]> https://biospectrumindia.com/news/95/4778/shanthas-pentavalent-vaccine-shan5-launched-in-india.html https://biospectrumindia.com/news/95/4778/shanthas-pentavalent-vaccine-shan5-launched-in-india.html Wed, 12 Nov 2014 09:25:00 +0530 Sanofi Pasteur, the vaccines division of Sanofi announced the launch of Shan5, its pediatric pentavalent vaccine developed and manufactured by its affiliate Shantha in India. The launch of Shan5 vaccine received prequalification status from the World Health Organization (WHO) in April 2014. Shan5's prequalification gives many more children in India access to the latest high-quality, fully-liquid, 5-in-1 vaccine. Shan5 is a fully-liquid five-in-one, convenient, safe and high-quality vaccine that provides effective protection for children from 6 weeks of age against five diseases: diphtheria, tetanus, pertussis, Hib and hepatitis B. Shan5 vaccine has been developed and is produced by Shantha in Hyderabad, India. Further, the prequalification helps Shan5 secure the supply of pentavalent combination vaccines in over 50 emerging and low-income countries. It adds to the existing list of four vaccines that Shantha manufactures, including Shanchol - the innovative cholera vaccine. "A significant number of babies born every year in India do not have access to modern vaccination programs. The launch of Shan5 in India means that 27 million babies born annually in India will have access to vaccination, to protect them from 5 potentially deadly diseases. By launching Shan5, Shantha will be contributing to filling this immunization gap for the benefit of babies and their parents", said Dr Harish Iyer, CEO, Shantha. As the first doses are being made available, the company has different plans to respond to different needs: public vaccination programs and vaccination in the private practice. ]]> <![CDATA[Strategy Behind Ebola]]> https://biospectrumindia.com/features/95/3537/strategy-behind-ebola.html https://biospectrumindia.com/features/95/3537/strategy-behind-ebola.html Tue, 11 Nov 2014 17:35:00 +0530 While fatality rates from the recent Ebola epidemic seem staggering, there are many scary viruses and bacteria that kill thousands every year without grabbing headlines. The world is brimming with many potent viruses of which Ebola is just one. The current Ebola outbreak ravaging in the West African continent has threatened the existence of the three countries, which are struggling in its clutches. For a developing country like India, situation is no better, given the confluence of existing environmental, socio- economic and demographic factors. The world is now witnessing the explosion of Criteria A pathogens that has no known treatment or prevention. India, with its over-burdened healthcare system and a huge population will be an easy prey to these ghastly viruses that almost kill all their victims. WHO has issued several recommendations to improve India's national response towards infectious outbreaks and these are in various stages of development. Ms Asheena Khalakdina, the WHO's Team Leader for Communicable Diseases, recently told Reuters that there were critical gaps in India's Ebola preparedness, which questioned the country's capacity to tackle an outbreak of such a magnitude. Most of these viruses are so rare and hence do not attract any corporate benefits for big pharma companies that invest millions into research and drug development. With potent viruses knocking on doors, it is important to have a collaborative response from the scientific community and the government to devise a comprehensive national strategy, cutting across all relevant spheres to strengthen disease surveillance and research. Need for a legal framework In this age of non-communicable diseases, contagious illness still accounts for 30 percent of disease burden in India. Apart from various biological and behavioral public health interventions, the government now needs to closely look at the structural intervention, that is, the legal framework to review health system preparedness. Though India has a number of legal mechanisms to tackle epidemics, they are not addressed under a single legislation. Recent unprecedented outbreaks happening across the globe have raised fears, as to whether a century old Epidemic Diseases Act of India, formulated in 1897, is sufficient to combat the new challenges. Currently, only the National Institute of Virology in Pune is explicitly tasked with studying viruses. Considering the plethora of dangerous bugs that sporadically erupt as epidemics in India, adequate research to contain the explosion of these viruses is not sufficiently carried out. Though Indian vaccine makers now have the capacity to quickly churn out prophylactic vaccines in wake of an epidemic, effective administration of this vaccine among the population is again a challenge. The threat of zoonoses Of late, the journey of microbial agents from one country to the other is often shorter than the incubation period of the organism, rendering border controls futile. New emerging and re-emerging infections have reiterated the need for a sound legal policy and framework to support efforts against emergent infections. Establishing more public-private partnership models to address the broad factors of emergence and immediate identification, quarantining and reporting of cases are major steps in this process. The challenge is broad, but in view of the increased pace of emergence and the globalization of disease, the importance of a comprehensive legal and policy framework cannot be overstated. The threat of Zoonoses Global experts indicate that most of the human pathogens originated from animals, and nearly 75 percent of emerging infectious diseases are zoonotic. Mr Manish Kakkar, a senior public health specialist at Public Health Foundation of India, pointed out that the veterinary sector, human sector and wildlife sector need to join forces to effectively combat the spread of zoonotic diseases. "In India, there is very little awareness about zoonoses, even among health professionals, which prevents prompt identification of the disease," added Mr Kakkar."Since humans exist with animals, the high-risk interfaces between humans and animals need to identified, as well as behavior that increases contact with wildlife needs to be altered to be able to tackle zoonotic disease outbreaks," said Mr Jonathan H Epstein, EcoHealth Alliance's Asia director. ]]> <![CDATA[Hilleman steps up efforts on oral cholera vaccine]]> https://biospectrumindia.com/news/95/3149/hilleman-steps-up-efforts-on-oral-cholera-vaccine.html https://biospectrumindia.com/news/95/3149/hilleman-steps-up-efforts-on-oral-cholera-vaccine.html Tue, 11 Nov 2014 13:48:00 +0530 Hilleman Laboratories, an equal joint-venture partnership between Merck and Wellcome Trust, has signed a memorandum of understanding (MoU) with Bangladesh-based ICDDR,B (formerly the International Centre for Diarrheal Disease Research, Bangladesh), an international public health research organization, and Incepta Vaccine, a leading pharmaceutical company in Bangladesh. As per the terms of reference of the MoU, Hilleman Laboratories will provide its expertise in further development, which will include the process, formulation and pre-clinical development of the vaccine. ICDDR,B will provide expertise with respect to clinical development and studies of the vaccine candidate and Incepta will support the development program in the area of process development, scale-up and cGMP manufacturing for pre-clinical and clinical studies. "This collaboration will allow the three organizations to work together and bring forward a cheap effective cholera vaccine to meet the needs of the developing world," said Dr Davinder Gill, chief executive officer, Hilleman Laboratories. "We are sensitive to the fact that cholera is endemic in developing nations, especially in the Bengal delta and sub-Saharan Africa. Identifying like-minded partners within four months of attaining the world-wide rights to the vaccine candidate in a strategic collaboration with Gotovax AB, has given a boost to our confidence in accelerating the process of optimizing the oral vaccine candidate and offer increased shelf life and reduce the projected gap in supply of cholera vaccine by the current manufacturers," added Dr Gill. Expressing his views, Dr John Clemens, executive director, icddr,b said, "Cholera is a major public health problem in several developing countries and we are excited to have the opportunity to translate research into prevention. An important challenge is to understand the effectiveness of vaccines in resource poor, high-risk settings. For a variety of reasons, responses to oral vaccines in the developing world are often lower than those seen in industrialized countries. Optimizing a vaccine candidate to fit such settings and saving lives is synonymous with our philosophy." Cholera is endemic in over 50 countries with estimated mortality of 100,000-120,000 deaths and a morbidity of 3.8-4.4 million annual cases attributed to this disease. The burden has led to a demand for an effective, low-cost cholera vaccine for use in epidemic outbreaks as well as for mass vaccinations in endemic settings. A market also exists for travelers to endemic regions. Demand estimates for cholera vaccines vary significantly across scenarios with an expected 30 million doses needed by 2016 rising to expected 200 million doses by 2025, assuming vaccination of all 1-14-year-old children in high risk populations. The GAVI Alliance has also expressed concern that current cholera vaccine manufacturers may not be able to meet the projected increase in demand, further strengthening the requirement for alternate, low-cost vaccine supply. ]]> <![CDATA[Temasek buys 10.16% stake in Intas Pharma ]]> https://biospectrumindia.com/news/95/5301/temasek-buys-10-16-stake-in-intas-pharma-.html https://biospectrumindia.com/news/95/5301/temasek-buys-10-16-stake-in-intas-pharma-.html Tue, 11 Nov 2014 13:45:22 +0530 Temasek's investment deepens its exposure to India's pharmaceuticals industry through a company with deepening comparative advantages. The sector is a good proxy for the needs of transforming economies, which is part of Temasek's investment themes. "ChrysCapital has been a valuable partner for Intas over the years. We are delighted to have lived up to the expectation of ChrysCapital and now look forward to welcoming a globally reputed investor like Temasek to enable Intas to reach greater heights in the years to come," stated Mr Binish Chudgar, vice chairman and managing director of Intas Pharmaceuticals as he announced the sale of the 10.16 percent stake on November, 10, 2014. Mr Chudgar added further, "In the domestic market, Intas is the 12th largest player in the Indian pharmaceuticals market with a strong chronic oriented portfolio. It is ranked 4th largest in chronic therapy areas with a strong presence in cardiac-diabeto and neuropsychiatry therapeutic segments." With three decades of progressive strategies, productive R&D, biotechnological expertise and investments in ten advanced manufacturing facilities across the globe, Intas has emerged as one of the fastest growing pharmaceutical organizations in the world. Mr Sanjiv Kaul, managing director, ChrysCapital said, "Intas has been an excellent investment for ChrysCapital with the company having grown revenues at 27% CAGR since its investment in CY06. Thanks to the promoters and its management team, the shareholders' value has rapidly grown over the last decade, boosted by its strong growth across India and export markets. ChrysCapital reaffirmed its faith in the Company with a fresh INR300 crore investment from a separate fund in CY12 and will continue to remain invested for the next few years." Over the past few years, Intas has successfully transitioned into a global generics player with over 50 percent of its revenues now coming from international markets. It has a global presence in over 70 countries backed by a strong product basket, pipeline and marketing infrastructure. Presently, US & Europe account for almost 75% of total international revenues and both these geographies continue to exhibit strong growth. The company is investing significant resources to build a pipeline of novel drug delivery technology based products. ]]> <![CDATA[Can the government revive Hindustan Antibiotics?]]> https://biospectrumindia.com/features/95/4964/can-the-government-revive-hindustan-antibiotics.html https://biospectrumindia.com/features/95/4964/can-the-government-revive-hindustan-antibiotics.html Tue, 11 Nov 2014 09:47:00 +0530 The Maharashtra-based HAL was the first drug manufacturing unit in the country to commercially produce antibiotics like Penicillin, Streptomycin, Gentamicin, Ampicillin and Amoxycillin among others. In 1954, when India was celebrating its seventh year of independence from the British rule, the World Health Organization (WHO) and the United Nations Children's Fund (UNICEF) along with the government of India came together to set up HAL in the public sector. The company was declared shaky way back in 1996. It was then referred to Board for Industrial and Financial Reconstruction (BIFR) in 1997, and the rehabilitation package was implemented by the government only from 2007 onwards. "Such delays in decision-making has also contributed to the dismal situation of the company, inspite of its attempts to rise up through diversification and modernization," regretted Mr Varkey. Bulk Penicillin manufacturing is an energy-intensive process. The steep hike in the energy cost in India resulted in unviability of Penicillin manufacturing in India, and all such units in the country were shut. "Meanwhile, China captured 90 per cent of the global market for Penicillin by offering favorable incentives to manufacturers, taking advantage of the globalization policy of the Indian government," he reasoned. Currently, HAL employs double the required manpower with pending outstanding loans. The company is struggling to meet its day-to-day administrative expenses and its pending salaries for several months. "As there is no money for buying raw materials, the production is possible if only advance payments for raw materials are received. A VRS Scheme is under the consideration by the government," said Mr Varkey. Today, the company's liabilities is getting accumulated at the rate of Rs 7 crore per month due to idling of the world-class plants and trained manpower. "The plants, buildings and utilities are deteriorating day-by-day due to lack of maintenance. It may be noted that if working capital of Rs 44 crore is made available, it is very easy to attain a turnover of Rs 250 crore as there is good demand for HAL products because of its high-quality, produced in a world-class plant," elucidated Mr Varkey. He continued, "This will fetch around Rs 40 crore per annum in the form of excise duty and sales tax to the government in addition to the profits. The indirect revenues and social benefits are extra. Alternatively, if the unit is closed, it is liable to clear all the liabilities which is much more than the money required for HAL's revival. The industrial relations in the company has reached an explosive stage as workers are suffering for so many years." Right now, a revival proposal for an amount of Rs 525 crore has been submitted, and the government is said to be seriously considering the proposal. Majority of the amount consists of the pending loans, statutory liabilities and pending dues of the employees. Hindustan Antibiotics Mazdoor Sangh (HAMS) is the name of the recognized Trade Union in HAL. HAMS has sent a letter to the Prime Minister Shri Narendra Modi in this regard. To raise the required capital, tenders were issued many times for selling its vacant land. "But for some reason or the other, the final approval has not been received for the same. As per the latest quotation received, the vacant land is worth more than Rs 1000 crore," revealed Mr Varkey. Maharashtra Housing and Area Development Authority (MHADA) was the highest bidder in the latest tender floated in April 2013. "Subsequently, we were directed by the Ministry in July 2014 that the government will support the revival plan through the Plan Fund and hence land need not be sold," said Mr Varkey. The Cabinet Minister Shri Ananth Kumar is also said to have expressed his strong desire to revive HAL and has asked the HAL management to prepare a road map for revival and growth of the company. The revival plan has been submitted by HAL to the authorities, which is under scrutiny. "Shri Ananth Kumar has directed the Department of Pharmaceuticals to take necessary action for the release of three months salary immediately. However, our management representatives could not meet Union Minister Shri Nitin Gadkari so far. We have met the Union Minister Shri Prakash Javadekar and appraised of the realities. He expressed great concern and promised us that he will bring it to the attention of Prime Minister and offered all possible help," opined Mr Varkey optimistically. So far HAL also has set up two subsidiary companies namely Maharashtra Antibiotics & Pharmaceuticals, and Karnataka Antibiotics & Pharmaceuticals. When asked about HAL's interest in mergers or acquisitions, Mr Varkey explained, "This is a policy matter and hence we have not got in touch with any company. It is possible for us to venture into domains like pharmaco-informatics, nanomedicine, chemo-informatics, and pharmaco-vigilance. We also propose to venture into high-tech areas like chipped capsules, magnetic tablets, and drug delivery systems. Collaboration with pharma and IT companies is a must. HAL is ready to support this kind of ventures by all possible means, after streamlining the present operations." At present HAL employs around 1,050 professionals. "They are facing acute poverty due to non-payment of salaries. They are still drawing meager salaries as per the 1997 pay-revision. It is a task to manage such a demotivated work force who have not even got salaries for their survival. No recruitments were done for many years, and no promotions were granted to the deserving employees due to the precarious financial conditions," Mr Varkey lamented. At present HAL's key customers include State Governments and the Central Government organizations like defense, railways, and ESIC. "Farmers are also the end users for our agricultural and veterinary products which are eco-friendly and cost-effective," Mr Varkey said. Though in a dismal stage at present, the R&D department at HAL have done a commendable job in the past and present. "The only two molecules invented in India, namely Hamycin and Aureofungin, are from the R&D department of HAL. Right now, we are in the development of specialty medicines like Potassium Iodate tablets, Ringer Lactate with Glycerin injection, Prussian Blue tablets, Ketamine detection kit, and Glipizide tablet, required for security forces, defense departments, and nuclear or cyanide disasters. New bio-fertilizers like Potash solubilizing bacteria is also being developed. It is heartening to find that though the stomach is empty, the brain is still active at HAL," expressed Mr Varkey joyfully, who was appointed as HAL's MD in November 2012. The company exports its medicines to Netherlands, Tanzania, Uganda, UAE, Sri Lanka, Kenya, Peru, and Republic of Yemen. ]]> <![CDATA[Agribiotechnology Conference to be held between Nov 25-26]]> https://biospectrumindia.com/news/95/5734/agribiotechnology-conference-to-be-held-between-nov-25-26.html https://biospectrumindia.com/news/95/5734/agribiotechnology-conference-to-be-held-between-nov-25-26.html Mon, 10 Nov 2014 17:31:52 +0530 Biotechnology has emerged as a rapidly growing arm of applied sciences with vast potential to provide solutions to the problems facing the agriculture sector. The agricultural scenario in India suffers from several challenges affecting short and long term outcomes for stakeholders (primarily producers and consumers of food) as well as sustainability. One of the ways to achieve the target average growth of 4% in the agriculture sector is to explore bio agriculture technologies and leverage their benefits. Biotechnology offers multiple innovative techniques to develop high yielding crops that can counter the biotic and abiotic stress associated with Indian agriculture. The strategic integration of biotechnology tools into Indian agriculture systems can revolutionize Indian farming and usher in a new era in agricultural scenario in the country. It is in this context that the 4th National Conference on AgriBiotechnology has been designed as a unique platform to bring together all stakeholders for achieving below objectives and unlock the potential in AgriBiotechnology: · Increasing awareness on the criticality of biotechnology in agriculture, · Bringing additional technologies into the mainstream of knowledge by sharing knowledge and experiences on the most recent innovations, trends, practical challenges encountered, solutions adopted etc. · Promoting healthy debate on contentious areas · Developing a coherent view of actions needed - a "call to action" to all stakeholders You can get more information on this conference here. MM Activ, publishers of BioSpectrum India and BioSpectrum Asia, are the media partner for this conference. ]]> <![CDATA[Seven new drug molecules offer hope for cancer control]]> https://biospectrumindia.com/news/95/4770/seven-new-drug-molecules-offer-hope-for-cancer-control.html https://biospectrumindia.com/news/95/4770/seven-new-drug-molecules-offer-hope-for-cancer-control.html Mon, 10 Nov 2014 14:47:01 +0530 A team of researchers at the School of Life Sciences of the Pondicherry University screened about 35,000 compounds and benchmarked the shortlisted seven compounds against some of the available potent drugs used for the treatment of Chronic Myelogenous Leukemia (CML). It is characterised by uncontrolled growth of white blood corpuscles (WBCs) in the bone marrow. It accounts for 12 percent of all cancers in India. According to the researchers, the seven yet-to-be-named new molecules (codenamed DB07107, DB06977, ST013616, DB04200, ST007180, ST019342 and DB01172) are more potent than the existing drugs such as ponatinib, imatinib, dasatinib and nilotinib available in the market to treat blood cancer. "Drugs manufactured using these newly-identified molecules will be more effective than the existing drugs as they arrest the progression of CML by binding the enzymes in the bone marrow that lead to overproduction of WBCs. These drugs will be at least twice more potent than the existing ones," said Dr R Baskaran, associate professor, department of biochemistry and molecular Biology, Pondicherry University and also lead researcher of the study. The team has proposed to seek a patent for their findings shortly. The drugs manufactured using the new molecules are expected to be cheaper than the existing ones. The findings are slated to be published in the journal 'Nature: Scientific Reports'. ]]> <![CDATA[WAC Buyer-Seller Meet: 180 pharma firms strike deals ]]> https://biospectrumindia.com/news/95/5052/wac-buyer-seller-meet-180-pharma-firms-strike-deals-.html https://biospectrumindia.com/news/95/5052/wac-buyer-seller-meet-180-pharma-firms-strike-deals-.html Mon, 10 Nov 2014 14:44:19 +0530 Held in four sessions that spanned for two days, the deliberations concluded on November 08, 2014 evening, triggering business potentials that would convert into crores of rupees. Organised by the ministry of commerce and industry at the WAC venue in Pragati Maidan, the meet was attended by as many as 150 Indian companies, besides the country's top drug regulatory officials. "From abroad, there were 56 delegates from 20 countries," said a source with Pharmexcil (Pharmaceuticals Export Promotion Council of India), which functions under the Union Commerce and Industry Ministry. The foreign firms included those from Europe (Sweden, Ukraine, Kyrgystan, Kazakhstan, Uzbekistan), USA, Canada, Africa (Rwanda, Mauritius), and Bolivia, besides Asian countries such as Iraq, Bahrain, Malaysia, Singapore, Sri Lanka, Nepal and Bangladesh. The Indian firms at the meet featured ARI Healthcare, Unilabs, TanMed, Guru, Ayushakti, BacFo, KDN, Maharishi, Kudos, Vashishta, Centurion and Perennial Pharma, among a host of others. ]]> <![CDATA[J P Nadda new health minister; S&T ministry gets Vardhan ]]> https://biospectrumindia.com/news/95/6844/j-p-nadda-new-health-minister-st-ministry-gets-vardhan-.html https://biospectrumindia.com/news/95/6844/j-p-nadda-new-health-minister-st-ministry-gets-vardhan-.html Mon, 10 Nov 2014 10:49:00 +0530 Mr. Jagat Prakash Nadda becomes the new health and family welfare minister after Prime Minister Mr. Narendra Modi expanded his ministry yesterday. Dr Harsh Vardhan has been relocated to science and technology, earth sciences ministry with a cabinet rank. Dr Jitendra Singh who was the minister of state for science and technology, has been relieved of the same. Besides the entry of 21 new ministers , there was also re-allocation of few portfolios to few ministers. The new health minister, Mr Nadda comes with more than 30 years of political and adminsitrative experience, did his graduation from Patna in Bihar and holds a post-graduate degree in political science and LL.B. from Himachal Pradesh University in Shimla. In 1998, Mr Nadda became cabinet minister (health and family welfare and parliamentary affairs) in Himachal Pradesh state government and served till 2003. During his tenure he started several health programs and promoted generic medicines, by engaging Ayurveda and Homeopathic doctors in different health programs along with MBBS doctors. In May 2012 J P Nadda is elected to Rajya Sabha (the upper house of Indian Parliament) and member of different committees including the one on health and family welfare. The stint of Dr Harsh Vardhan as S&T minister is being seen again as temporary one since he might be moved to oversee Delhi assembly elections for BJP. ]]> <![CDATA[India's competitive edge: Advance science at lower costs, Dr Shaw]]> https://biospectrumindia.com/news/95/7627/indias-competitive-edge-advance-science-at-lower-costs-dr-shaw.html https://biospectrumindia.com/news/95/7627/indias-competitive-edge-advance-science-at-lower-costs-dr-shaw.html Mon, 10 Nov 2014 09:44:00 +0530 The conference is a one-stop platform for lifescience organizations, investors and bankers, offering them a panoramic view on the emerging investment opportunities in the lifesciences sector. Addressing the conference delegates and Biotechnology Student Entrepreneurship Teams (BEST) participants, Dr Kiran Mazumdar-Shaw, CMD, Biocon, delivered her presentation on the theme 'Enabling an Efficient and Effective Research and Development Ecosystem in India'. "Our recent Indian Mars mission's success shows our ability to be globally relevant and at the same time delivering scientific advances at lower costs. We need a winning attitude and a belief in ourselves that we can do great science in this country. However, it is not about 'me-too' research, but rather it's all about path-breaking research," she began. Dr Kiran pointed out the critical components in a research ecosystem. "It starts with the academic research institutes. It is all about the symbiotic relationship between the academia and industry. Each component rely on each other to keep building that ecosystem. Unfortunately, in India, this critical component doesn't exist. Hence most researches die away within the walls of the laboratories," she opined. The lab-to-market journey is a virtuous cycle, held Dr Kiran. "Academic research is about conceptualizing new ideas and discovering new ways of doing things. This academic research is supported by public funds. For academic research to be productive, we need to get people interested in it and take the ideas to proof-of-concept (PoC) stage. This is where young start-ups have an important role to play. So this is about creating accretive value to that concept. Funding for the proof-of-concept level has to come from various funding schemes offered by BIRAC and others. It is also important to find angel investors at this stage," she explained. "Post the PoC stage, the start-ups need to become a larger organization, and take it to the industry and this would need the support of venture capitalists and capital markets," she added. "When you create this important ecosystem, then you will find industries looking out for start-ups who are creating research with interesting concepts, and thus start-ups will be able to license their IPs. Simultaneously, the academic research will start to strengthen and the whole patenting culture will kick-in and the ecosystem will become an effective ecosystem," Dr Kiran elucidated. Talking about the funding, Dr Kiran mentioned, "When you want to fund your research, new concepts and ideas, you will need government's funding, research-oriented funds and support from accelerators." Dr Kiran feels that incubators needed to be created at every research institutes. "Very few research institutes have incubators in our country. If incubators do not move research ideas from concepts to PoC stage, then the virtuous cycle won't get initiated. However, once you start the cycle, the venture capitalists come on the scene and take the concept to the market," she added. Adding on the imperativeness of incubators, she expressed that start-ups have to happen in incubators like government incubators preferably anchored by academic research institutes. "The location of incubators is very crucial. Every technology institute in the country must have good incubators. Those incubators must be able to nurture start-ups and invite others as well. It is important that we give preference to our own researchers. Many incubators in the US charge about $30 fee and let them take advantage of every part of that incubator," she revealed. Dr Kiran believes that if we can create a good ecosystem and build a strong path from lab-to-market, it will pave way for an exciting ecosystem. "If we want to get the government's attention in policy making, ABLE needs to write a whitepaper on building the ecosystem, about funding from the government, research institutes and incubators. We have to change the concept of how we access capital markets. We need to create the interest among companies to take the PoC to the market funded through capital markets," commented Dr Kiran. She warned that investing in old, tried-and-tested archaic models is not going to pay any dividends. "It is going to take a long time before you see the profits. If people can do it in e-tailing, why not in biotech? This is all about investment in transformational change and investment in the future. We need to inculcate this thought-process among the government, investors and policy makers. Creating this ecosystem will create jobs through start-ups and take advanced scientific ideas to market. Our competitive edge is in taking advanced science at lower costs," held Dr Kiran. She defined affordable innovation as high science at lower costs in a global landscape delivered in a competitive way. "That is what India's model is about. This is what Mangalyaan was all about. And we can do that in Biotechnology (BT)," she encouraged. "We have to change," opined Dr Kiran, "India's narrative in Information Technology (IT) and Biotechnology; and today's era demands that change. IT has earned a huge name for India making a world-class name for its software capabilities. In lifesciences India is very strong. A third of the leading lifesciences companies in the world and research labs are of Indian origin. We need to build that credibility for ourselves." Comparing the research culture in India and other countries, Dr Kiran said that in India the research focus is primarily on research publication rather than on creating IPs. "We prefer to publish first and then try to patent the IP and ultimately lose the IP. However, globally, first they patent and then focus on publication. This is a golden rule followed in all academic institutes globally. This patenting culture has to start in a stronger way in Indian laboratories. It is the first starting point of value creation," Dr Kiran commented. Dr Kiran emphasized that big companies are looking for good, new ideas. "The research landscape of big pharma companies is not what it used to be. They need redesigning. They are looking for start-up ideas and innovation. They are willing to fund the companies to take it further. Biotechnology is the next frontier for investment. The next 5 years are going to be exciting and attractive on returns. We can do what the US is doing. If venture capitalists can get a product to the market, and investors can bet on that product, and if the government can subsidize 50 per cent of the investment, then there is some hope to see this ecosystem being created," she said optimistically. Commenting on the job creation, she said that most jobs are not going to be from big companies. "They will come from start-ups and smaller organizations. The government has to focus on start-ups and entrepreneurship to create those jobs. If this model is adopted, we need to make sure start-ups and entrepreneurs get funded through government, venture capitalists, angels, and capital markets have a role to play," she said. Dr Kiran noted a few stellar milestones of the Indian lifesciences sector. She pointed, "Indian BT industry recorded CAGR of over 20 per cent in the last 10 years. The sector aims to realize $100 billion in revenues by 2025. India is also ranked 12th in the biotech sector globally, and 3rd in APAC region. The exports themselves contribute over a half of Indian biotech industry revenues." In her concluding remarks, Dr Kiran emphasized that going forward the Indian science and technology (S&T) sector needs thrust from the Prime Minister's Office. "The research culture needs freedom to operate. Monitoring should be made significant in research institutes. There needs to be more investments in scaling up centers of excellence. Establishing more genomic research institutes based on big data analytics in Bangalore, Hyderabad and Pune through centre-state partnership should be welcomed. Also, establishing institutes for synthetic biology in Bangalore, Chennai and Visakhapatnam through centre-state partnership should be encouraged," she suggested. "There is a need now for curriculum revamping in IT, BT, Nanotechnology (NT) and Computer Science in the country. Lastly, there is a need to frame S&T policies emulating the US, Australia and Israel, which have excellent policies," Dr Kiran ended. ]]> <![CDATA[inVentis to distribute TriLink products in India]]> https://biospectrumindia.com/news/95/5054/inventis-to-distribute-trilink-products-in-india.html https://biospectrumindia.com/news/95/5054/inventis-to-distribute-trilink-products-in-india.html Fri, 07 Nov 2014 17:17:17 +0530 California-based TriLink BioTechnologies announced that it has entered into a distribution agreement with India-based inVentis Technologies (Inventis) inVentis is a distribution and manufacturing company specializing in the life science and applied science, research, diagnostics and QC market. The agreement allows inVentis to market TriLink's complete line of nucleic acid-based products. This includes TriLink's stocked and custom nucleotides, oligonucleotides, and mRNA, as well as CleanAmp Hot Start PCR Products. "With the biotech industry growing rapidly in India, TriLink has been looking for the right opportunity to enter the market. InVentis provides an extensive line of life science products to the biotech and pharmaceutical market and we feel that our high quality nucleic acid-based products will complement their offering and help advance research in the area," commented TriLink's president and CEO, Dr Richard Hogrefe. ]]> <![CDATA[US FDA nod for Olysio/Sovaldi HCV combo]]> https://biospectrumindia.com/news/95/4990/us-fda-nod-for-olysio-sovaldi-hcv-combo.html https://biospectrumindia.com/news/95/4990/us-fda-nod-for-olysio-sovaldi-hcv-combo.html Fri, 07 Nov 2014 17:15:58 +0530 The US Food and Drug Administration (US FDA) has approved Johnson & Johnson (J&J)and Medivir's Olysio (simeprevir) in combination with Gilead Sciences' Sovaldi (sofosbuvir) as an oral, interferon- and ribavirin-free treatment option for genotype 1 chronic hepatitis C infection in adults. J&J and Medivir further mentioned that the recommended treatment duration of the combination is 12 weeks for patients without cirrhosis or 24 weeks for patients with cirrhosis. The approval was based on the data from two cohorts of the COSMOS study, which showed that 95 percent of patients with METAVIR scores of F0-F3 receiving 12 weeks of treatment of the drug Olysio in combination with Sovaldi achieved sustained virologic response or cure, the absence of HCV detected in the blood 12 weeks after the end of treatment. "We are pleased that an interferon-free, ribavirin-free Olysio-based combination is now approved in the US. The availability of multiple treatment options is important to help offer an opportunity for cure and we believe Olysio will play a meaningful role in this respect," commented Mr Gaston Picchio, hepatitis disease area leader at J&J's Janssen R&D unit. ]]> <![CDATA[Advinus meets milestone in drug discovery alliance]]> https://biospectrumindia.com/news/95/4559/advinus-meets-milestone-in-drug-discovery-alliance.html https://biospectrumindia.com/news/95/4559/advinus-meets-milestone-in-drug-discovery-alliance.html Fri, 07 Nov 2014 12:42:16 +0530 The achievement of this milestone substantiates the successful path of the collaboration and confirms Advinus' proven strength in providing innovative solutions with speed and quality - essential ingredients for discovery of safe and effective medicines. A payment of $3 million has been made by Takeda to Advinus to mark the achievement. In October 2012, Advinus and Takeda announced a multi-year multi-project collaboration in the area of drug discovery. In this collaboration, Advinus is responsible for carrying out all the research required to identify candidate molecules for clinical development in several therapeutic areas while Takeda is responsible for the development and commercialization of these candidates. In October 2013, Advinus met the milestone that was set to mark the end of the first year of the collaboration. The rapid progress of the research programs over the past year has resulted in the milestone to mark the completion of the second year of the collaboration. "The rapid progression of the collaborative programs by Advinus' young and talented scientists has strengthened the Takeda-Advinus partnership, and the approval of the milestone demonstrates the confidence that Takeda has in Advinus' ability to deliver novel and effective candidates for drug development in a rapid and cost effective manner," said Dr Kasim Mookhtiar, CSO, Advinus. ]]> <![CDATA[Govt bracing up to popularise traditional medicines: Minister]]> https://biospectrumindia.com/news/95/5481/govt-bracing-up-to-popularise-traditional-medicines-minister.html https://biospectrumindia.com/news/95/5481/govt-bracing-up-to-popularise-traditional-medicines-minister.html Fri, 07 Nov 2014 09:58:34 +0530 India's ancient medicinal systems are being given a 'new-look image' as part of the new government's effort to popularise them without losing their essence, Union Tribal Affairs Minister Jual Oram said. Such a concerted exercise will specially benefit rural India where people largely rely on local herbal doctors, he said while inaugurating a two-day Traditional Healers Meet in the national capital as part of the Sixth World Ayurveda Congress (WAC). â€œDeliberations are on with experts and practitioners ensure that such a plan benefits the country's huge number of villages,â€? Mr Oram told a gathering of healers, who called upon the government to give accreditation to deserving traditional healers. The minister, while interacting with the Pragati Maidan gathering that had 100-plus healers who would present a string of research papers on ancient traditional treatment practices across India, expressed optimism that the meet would facilitate exchange of ideas between practitioners of different branches of ancient medicines. â€œThe outcome of the deliberations would further enable the government to chart ways on empowering Ayurveda and traditional Indian treatment systems,â€? added Mr Oram, himself a tribal leader. Bengaluru-based scholar, Darshan Shankar said in his keynote address that the healers' fraternity had two suggestions before the government to strengthen traditional cure in India. â€œOne is a scheme that would ensure a home-level network of use of herbal medicines. The other is fast and prompter accreditation of healers by a competent body of experts,â€? said Prof Shankar, who is Vice Chancellor of Institute of Trans Disciplinary Health Sciences and Technology (ITDHST), Bengaluru. Prof Ritu Priya of Jawaharlal Nehru University, Delhi, stressed the need for bridging a gap between traditional and modern medicines in present-day India. Healers from the south, west, central and Northeast India at the meet expressed anguish that traditional treatment systems in India were not getting their due recognition even as they formed the basis for modern medicine. ITDHST's Prof G Hariramamurthi welcomed the gathering. The sixth WAC will begin on Friday and conclude on Sunday with Prime Minister Narendra Modi addressing the valedictory session. ]]> <![CDATA[World Economic Forum honours Avesthagen India as a Global Growth Company]]> https://biospectrumindia.com/news/95/6870/world-economic-forum-honours-avesthagen-india-as-a-global-growth-company.html https://biospectrumindia.com/news/95/6870/world-economic-forum-honours-avesthagen-india-as-a-global-growth-company.html Fri, 07 Nov 2014 09:51:59 +0530 The World Economic Forum announced its selection of Global Growth Companies (GGCs) in South Asia. Seventeen of the region's most dynamic and high-growth companies are considered trailblazers, shapers and innovators that are committed to improving the state of the world. GGCs are fast-growing companies with the potential to become global economic leaders. The nominated GGCs represent a broad cross-section of industry sectors but share a track record of exceeding industry standards in revenue growth, promotion of innovative business practices and demonstration of leadership in corporate citizenship. The selected companies are: 4G Identity Solutions, ANI Technologies, Avesthagen, Bandhan Financial Services, Centum Electronics, Finolex, Flipkart, Forbes Marshall, InterGlobe Enterprises, Justdial, MakeMyTrip, Nash Industries, Persistent Systems, Radikal Foods, RBL Bank, Sobha, and Transasia Bio-Medicals. "The World Economic Forum is proud to recognize these 17 champions that are at the forefront of driving responsible economic growth, job creation and entrepreneurism in South Asia. We look forward to the active and dynamic role they will play at our meeting in New Delhi, working with the region's leaders to foster inclusive, sustainable growth in the region," said David Aikman, Managing Director and Head of New Champions at the World Economic Forum. ]]> <![CDATA[Controversial HPV vaccine case lingers on ]]> https://biospectrumindia.com/news/95/5341/controversial-hpv-vaccine-case-lingers-on-.html https://biospectrumindia.com/news/95/5341/controversial-hpv-vaccine-case-lingers-on-.html Thu, 06 Nov 2014 17:25:34 +0530 The 2012 case pertaining to the clinical trials of human papillomavirus (HPV) vaccines, Gardasil and Cervarix, conducted on estimated 1200 tribal girls in the far off areas of Gujarat, Andhra Pradesh, and Telengana, has been deferred to January 13, 2015 for the hearing. The ongoing case in the Supreme Court of India was supposed to be heard on October 30, 2014 but has been moved to next date due to unavailability of the government lawyers representing the states. As per a source present in the court, since the representation was not adequate from the respondents side, the SC panel decided to hear the case later. The petition number 558/2012, filed by Ms Kalpana Mehta, Ms Nalini Bhanot and Ms V. Rukmini Rao against the multinational companies, MSD Pharmaceuticals and Glaxo Smithkline, was earlier heard on August 12, 2014. The court in its order has directed the companies to present their arguments in the next hearing. The court has sought to know what actually caused the deaths of some participants in the clinical trials. It has also asked the respondents to file their reply on whether proper consent was obtained from the girls and/or their families prior to their participation in the experiment. It is worthwhile to recall that about 5 percent of the partcipants in the demo trials suffered from auto-immune diseases and other health problems. The petitioners who had requested the court to suspend the licenses for marketing and administration of HPV vaccines, received the shot in arm when the Parliamentary standing committee in 2013, strongly condemned the way these demonstrative trials were done. It had also called for a deep enquiry in the matter. However, the the Program for Appropriate Technology in Health (PATH) which has been involved in the trials has been refuting the allegations. Similarly, the Merck and GSK too has denied any wrongdoing. The much publicized case has generated lot of interest in India and abroad and is being closely watched over for its implications on the industry. Now, all eyes are on the first month of the new year to know what decision SC panel takes on the issue. Given the lack of enough response from the regulatory bodies and the government lawyers in the past, it certainly is not going to be the amusing one for them. ]]> <![CDATA[LinkedIn rates J&J and Pfizer among InDemand Employers 2014]]> https://biospectrumindia.com/news/95/8365/linkedin-rates-jj-and-pfizer-among-indemand-employers-2014.html https://biospectrumindia.com/news/95/8365/linkedin-rates-jj-and-pfizer-among-indemand-employers-2014.html Thu, 06 Nov 2014 15:20:23 +0530 Six out of the 100 companies listed were in the Life Sciences industry including pharmaceutical and biotechnology. Johnson & Johnson is seen at the 11th spot, while Pfizer occupies the 17th and Novartis at 21st. The 28th spot was occupied by Swiss-based Bayer. Roche and UK-based GlaxoSmithkline takes the 51st and 75th spots. Tech honchos Google and Apple occupy the 1st and 2nd spots respectively, while Microsoft takes the 4th, followed by Facebook at 5th. ]]> <![CDATA[Glenmark Generics gets US FDA nod]]> https://biospectrumindia.com/news/95/5756/glenmark-generics-gets-us-fda-nod.html https://biospectrumindia.com/news/95/5756/glenmark-generics-gets-us-fda-nod.html Thu, 06 Nov 2014 15:19:30 +0530 Glenmark Generics has announced that it has received approval from the United States Food and Drugs Administration (US FDA) to market generic version of AstraZeneca's Prilosec, a drug used for treatment of ulcer. "Glenmark Generics (GGI) has been granted the final abbreviated new drug approval (ANDA) from the US FDA for Omeprazole Delayed Release Capsules, their generic version of Prilosec by AstraZeneca," the company said in a statement. The company has received final approval for 10, 20, and 40 mg strengths of Omeprazole. According to IMS sales data, for the 12 month period ending September 2014, Omeprazole garnered annual sales of approximately $520 million. ]]> <![CDATA[Suven's CNS molecule enters phase-1 clinical trial]]> https://biospectrumindia.com/news/95/5373/suvens-cns-molecule-enters-phase-1-clinical-trial.html https://biospectrumindia.com/news/95/5373/suvens-cns-molecule-enters-phase-1-clinical-trial.html Thu, 06 Nov 2014 15:16:22 +0530 SUVN-G3031 - a potent, selective, brain penetrant and orally active Histamine H3 antagonist for the treatment of cognitive dysfunction associated with Alzheimer's Disease or Schizophrenia has completed all the pre-clinical, safety and early toxicological studies, GLP toxicological studies and was submitted for Investigational New Drug Application {IND) to conduct phase-1 clinical trial with the indication for Cognition in Alzheimer's Disease under 505(1) of the Federal Food, Drug and Cosmetic Act (FDCA) which was assigned an IND number 123179. Based on the IND, "A Single Center, Double-blind, Placebo-controlled, Randomized, Phase 1 Study to Evaluate the safety, Tolerability, and Pharmacokinetics of SUVN-G3031 after Single Ascending Doses and Multiple Ascending Doses in Healthy Male Subjects" for Cognition in Alzheimer's Disease is underway in USA. "We are very pleased that the second compound from our pipeline of molecules in CNS has moved into clinical trial that is being developed for cognitive disorders in Alzheimer's and Schizophrenia with high unmet medical need which has huge market potential globally," said Mr Venkat Jasti, CEO, Suven. ]]> <![CDATA[Sami Labs buys KCP biotech]]> https://biospectrumindia.com/news/95/4709/sami-labs-buys-kcp-biotech.html https://biospectrumindia.com/news/95/4709/sami-labs-buys-kcp-biotech.html Thu, 06 Nov 2014 15:14:59 +0530 KCP Biotech is a unit of The KCP Limited, established in 1941, is a producer of high performance goods and services in cement, heavy engineering, sugar and hydel power. Sami Labs' R&D center is located in Bangalore, along with four manufacturing facilities. It also has a manufacturing facility in Hyderabad, and in the State of Utah, USA. With the purchase of KCP biotech, it will now have two manufacturing facilities in Hyderabad. ]]> <![CDATA[India invites researchers from South Asia]]> https://biospectrumindia.com/news/95/4557/india-invites-researchers-from-south-asia.html https://biospectrumindia.com/news/95/4557/india-invites-researchers-from-south-asia.html Thu, 06 Nov 2014 13:47:21 +0530 The Indian government, led by Prime Minister Mr Narendra Modi announced the launch of the India Science and Research Fellowship (ISRF) Program, inviting researchers from neighboring South Asian countries like Afghanistan, Bangladesh, Bhutan, Maldives, Myanmar, Nepal and Sri Lanka to collaborate with Indian research institutes and academia and establish partnerships. A Memorandum of Understanding was signed by Dr Arabinda Mitra, advisor and head, International Bilateral Cooperation representing DST, India, and Prof. Mesbahuddin Ahmad, president, representing BAS, on Oct 16, 2014 in New Delhi, India, towards implementation of the Fellowship scheme for Bangladesh researchers from 2015. The Indian High Commission in Dhaka said in a statement that the researchers will work in Indian universities and research institutions. The program requires scientists or researchers with a minimum academic qualification of PhD /M.Tech /M.Sc and 4-6 years research or teaching experience to undertake research in Indian R&D institutions. The researchers will also enjoy perks like travel allowance, sustenance allowance, contingency grants and medical facilities, among others. Bangladesh Academy of Sciences, Dhaka (BAS) will be implementing the program in partnership with the Center for International Co-operation in Science (CICS), Chennai, India. ]]> <![CDATA[Biocon Academy graduates records 100% placement]]> https://biospectrumindia.com/news/95/5497/biocon-academy-graduates-records-100-placement.html https://biospectrumindia.com/news/95/5497/biocon-academy-graduates-records-100-placement.html Thu, 06 Nov 2014 13:46:00 +0530 All 30 students scored above 2.75 CGPA on a scale of 4. Biocon Academy claimed that the whole batch has recorded 100 percent placement. Leading companies from the Indian pharma industry, including Intas Pharmaceuticals, Sanofi India, Richcore Lifesciences, Zydus Biologics, GlaxoSmithkline India, and Theramyt Novobiologics have participated in the campus recruitment process. The job offers covered a wide variety of profiles including production, quality assurance, regulatory affairs, R&D and marketing. Ms Kiran Mazumdar-Shaw, CMD of Biocon & Biocon Academy's chief mentor, said, "We are happy to develop high-end talent for the life sciences sector at Biocon Academy who are being picked up by leading firms in the sector. Our aim is to address the huge skill deficit of the biopharma sector through Biocon Academy students who have been educated on the 'business of science' through experiential learning by experts from KGI and Biocon." The 'Biocon KGI Certificate Program in Biosciences' is a 16-week, full-time certificate program being offered by Biocon Academy in collaboration with the Keck Graduate Institute of Claremont, California, USA. Dr Shelly Schuster, president, Keck Graduate Institute, said: "These students have had profound learning experiences on various aspects of the pharmaceuticals industry. They have had a multitude of opportunities to engage in the processes that would find applications in producing biomolecules, pharmaceuticals & diagnostics. I am sure that each one of them will be a major contributor in their area of interest in the lifesciences industry and continue to learn and be passionate about their profession." Gold medals Ms Avantika Diwakar, Ms Noopur Gupta and Sowmyan Sreenevasan topped the charts and were the proud recipients of the prestigious 'Biocon Academy Gold Medal for Academic Excellence'. The academy also presented 'Kudos Award' to eight other students for their notable performance during the course of the program. Sowmyan Sreenevasan, one of the gold medalists, said, "I have gained invaluable experience through the Biocon-KGI certificate program as it has equipped me with the indispensable skills demanded of professionals in the lifesciences industry. Additionally, the program has also helped me develop soft skills, an aspect that is often overlooked by academic institutes." Third batch The Third batch of the Biocon Academy commenced on 3rd Nov' at Bangalore. A group of 30 bright, young students were chosen from over 300 applications received from different parts of India, including Uttar Pradesh, Rajasthan and Chhattisgarh in addition to Andhra Pradesh, Kerala, Tamil Nadu and Karnataka.The online application process for the fourth batch will commence from 10th Nov'2014. ]]> <![CDATA[Indians may soon get free health insurance cover]]> https://biospectrumindia.com/news/95/4667/indians-may-soon-get-free-health-insurance-cover.html https://biospectrumindia.com/news/95/4667/indians-may-soon-get-free-health-insurance-cover.html Thu, 06 Nov 2014 13:28:03 +0530 The union government is considering to provide all citizens with free drugs and diagnostic treatment, as well as insurance cover to treat serious ailments under the the National Health Assurance Mission. The entire programme is likely to go live in phases can cost close to Rs. 25000 crores. The plan that is expected to be rolled out from April 2015, will cover the entire population by March 2019. Currently India government spends only about one percent of gross domestic product on healthcare. It is much lesser when compared to three percent in China and aroudn eight percent in the United States. It is a fact that currently more newborns die in India than in poorer neighbours such as Bangladesh, and preventable illnesses such as diarrhoea kill more than a million children every year. The universal health coverage could therefore ensure the huge population of India against the most common diseases. However, it might take more than a decade to build infrastructure and streamline the healthcare facilities. ]]> <![CDATA[Ebola will be on decline by 2016: F&S Report]]> https://biospectrumindia.com/news/95/5362/ebola-will-be-on-decline-by-2016-fs-report.html https://biospectrumindia.com/news/95/5362/ebola-will-be-on-decline-by-2016-fs-report.html Thu, 06 Nov 2014 12:31:27 +0530 As per the report, Ebola virus is being contained in many of the developed nations like the US, Spain and France due to better infrastructure and the availability of rapid and quality treatment. It also mentions that the porous borders of Western Africa and its neighboring countries still pose a threat of a global epidemic of Ebola. The two countries at most risk are China and India who have large stakes in Africa, and due to increasing trade interactions and open sea ports, there is a higher chance of Ebola transmission to these countries. The findings of report predict that, optimistically, there will be a decrease in the number of Ebola cases globally in late 2015-early 2016 due to the commercial availability of approved vaccines and treatment in the hard hit nations of Africa. As per report, there will be a spur in the molecular methods market due to the urgent demand for sensitive and rapid tests in detecting and containing this disease. According to it, the Immunodiagnostics market will also continue to grow due to its cost effectiveness especially for initial screening of Ebola ]]> <![CDATA[AZ, Pharmacyclics & Janssen partner on immuno-oncology combination trials ]]> https://biospectrumindia.com/news/95/5540/az-pharmacyclics-janssen-partner-on-immuno-oncology-combination-trials-.html https://biospectrumindia.com/news/95/5540/az-pharmacyclics-janssen-partner-on-immuno-oncology-combination-trials-.html Wed, 05 Nov 2014 16:41:12 +0530 AstraZeneca, Pharmacyclics, Inc. and Janssen Research & Development announced that they have entered into a clinical trial collaboration to evaluate the efficacy and safety of AstraZeneca's investigational anti-PD-L1 immune checkpoint inhibitor, MEDI4736, in combination with IMBRUVICA (ibrutinib), an oral Bruton's tyrosine kinase inhibitor, co-developed by Pharmacyclics and Janssen and commercialised outside the US by Janssen affiliates. The study will assess the combination as a treatment for patients with haematological cancers including diffuse large B-cell lymphoma and follicular lymphoma, which are investigational uses for both compounds. The financial terms of the agreement have not been disclosed.MEDI4736 blocks the signals that help tumours avoid detection by the immune system, countering the tumour's immune-evading tactics. Ibrutinib blocks signals that tell malignant B cells (white blood cells that produce antibodies) to multiply and spread uncontrollably. Preclinical evidence suggests that the combination of these two agents may lead to an enhanced anti-tumour immune response. The Phase I part of the trial is expected to establish a recommended dose regimen for the combination of MEDI4736 and ibrutinib, and the Phase IIa part of the trial will assess the safety and efficacy of the investigational combination. Under the terms of the agreement, the two-part trial will be conducted by Pharmacyclics. Mr Briggs Morrison, executive VP, global medicines development & chief medical officer, AstraZeneca, said, "We are committed to progressing our strong immuno-oncology pipeline as rapidly as possible. Our partnership with Pharmacyclics and Janssen supports our exploration of the potential of anti-PD-L1 in hematological cancers and is further evidence of our belief that combination therapies have the potential to be one of the most effective ways of treating cancer." "Cancer drug development is at one of its most exciting, productive periods in history," said Dr Peter Lebowitz, global oncology head, Janssen. "This collaboration reflects the common goal of all three companies to better understand new treatment options and combinations - with the ultimate goal of making a difference to the lives of people with hematologic malignancies." Preclinical evidence suggests that the combination of these two agents may lead to an enhanced anti-tumor immune response. ]]> <![CDATA[Applikon signs distributor agreement with Spinco Biotech]]> https://biospectrumindia.com/news/95/7198/applikon-signs-distributor-agreement-with-spinco-biotech.html https://biospectrumindia.com/news/95/7198/applikon-signs-distributor-agreement-with-spinco-biotech.html Wed, 05 Nov 2014 16:31:14 +0530 Mr Erik Kakes, executive VP, sales & marketing, Applikon Biotechnology said, "In Spinco Biotech we have found a partner organization that matches the quality of equipment and support that we are aiming to bring to the worldwide biopharmaceutical market. Our range of high end bioreactor systems complements the product range of Spinco and their excellent after sales organization guarantees our customers the optimal support." The financial terms of this new agreement were not disclosed. "This new agreement offers our customers innovative solutions and total quality satisfaction. We are very pleased to be working with the Applikon Biotechnology team and look forward to a long-term successful relationship," said Mr Arvind Thyagarajan, director, business development, Spinco Biotech. ]]> <![CDATA[Novo Nordisk reports effective trial data on its obesity drug]]> https://biospectrumindia.com/news/95/5542/novo-nordisk-reports-effective-trial-data-on-its-obesity-drug.html https://biospectrumindia.com/news/95/5542/novo-nordisk-reports-effective-trial-data-on-its-obesity-drug.html Wed, 05 Nov 2014 16:29:48 +0530 The results were presented at ObesityWeek 2014, the 2nd Annual Congress of The American Society for Metabolic and Bariatric Surgery and The Obesity Society. According to the company, 92 percent (9 out of 10) of trial participants lost weight with liraglutide 3 mg treatment, in combination with diet and exercise, compared with 65% on placebo treatment. People who completed the trial (56 weeks) demonstrated significantly greater weight loss of 9.2 percent compared with a 3.5 percent reduction in the placebo group (estimated difference [ED] 5.7 percent, p < 0.0001). In addition, weight loss with liraglutide 3 mg was similar across a range of baseline body mass index (BMI) subgroups in people with obesity, from overweight to Class III obesity, at 56 weeks (p=0.054, %; p=0.54, kg) and independent of prediabetes status at screening (-8.0% with vs -7.9% without, p=0.59). A larger proportion of people treated with liraglutide 3 mg completed the trial compared with those on placebo (72 percent vs. 64 percent). All treatment groups followed a reduced-calorie diet and an increased physical activity programme. Weight loss associated with liraglutide 3 mg was accompanied by improvements in health-related quality of life (HRQoL) as measured by three different questionnaires. Greater improvements were seen with liraglutide 3 mg vs placebo. The Impact of Weight on Quality of Life-Lite (IWQoL), total score improved mostly due to better physical function. Both the Short-Form (36) Health Survey (SF-36) summary of physical scores and mental health scores improved. "Obesity is more than a disease of excess weight," said Dr Ken Fujioka, Department of Nutrition and Metabolic Research, Scripps Clinic, La Jolla, California and a SCALE clinical trial investigator. "We know that people with obesity may experience increased physical and mental health problems, as well as a reduced quality of life. It is encouraging to see data suggesting that the weight loss benefits of liraglutide 3 mg are associated with improved health-related quality of life for people with obesity." In addition, the total Treatment Related Impact Measure-Weight (TRIM-W) score was better at 56 weeks with liraglutide 3 mg compared with placebo treatment. ]]> <![CDATA[IKMC 2014: New Innovations & initiatives]]> https://biospectrumindia.com/news/95/5494/ikmc-2014-new-innovations-initiatives.html https://biospectrumindia.com/news/95/5494/ikmc-2014-new-innovations-initiatives.html Wed, 05 Nov 2014 14:43:00 +0530 The conference, apart from the sessions, also included a few new initiaives and tie-up's. The Gates foundation, USAID and UKAID all feature prominenty among them. The first of the initiatives was that IKP will be partnering with USAID and Gates foundation to select and fund innovations in TB diagnostics and screening. 14 innovators will be selected from the applicants and a sum of $1 million has been allocated for the same. Speaking on the occasion, Dr Nancy Godffrey, director of Health office, USAID, said that the number of TB cases have risen significantly, which is alarming considering that it was a curable disease. USAID and BIRAC, with IKP have issued a second call for proposals from innovators who have interesting solutions for TB control. Apart from innovation, the creteria would be to look at cost effective, indigenious solutions with indicative target profiles to help in the fight aganist TB. In another significant initiative for IKP, it will be the implementing partner for BIRAC's Biotechnology Ignition Grant Scheme. The fourth call for BIG is open now. This would be a grand focused challenge. Dr Renu Swarup, from the ministry of Science and technology and head of BIRAC, said that it was very excited to be a part of the scheme. She added further, that finding a solution is one but there is a need to commercialize the same and ensure that it reaches the people. The IKP has also exchanged a letter of Intent with the department of International development, UK or UKAID to partner in countries like South Asia and East Africa where the international body already has a significant presence. Ms Sabina Bindra Barnes, from UKAID said that they were very delighted to come on board. ]]> <![CDATA[Dengue Vaccine expected by 2015: Sanofi]]> https://biospectrumindia.com/news/95/5600/dengue-vaccine-expected-by-2015-sanofi.html https://biospectrumindia.com/news/95/5600/dengue-vaccine-expected-by-2015-sanofi.html Wed, 05 Nov 2014 14:06:22 +0530 Sanofi has announced that its vaccine against mosquito-borne viral disease, dengue could be available in the country by the end of next year. The company will file for the registration of its vaccine candidate and subject to regulatory approval, the world's first dengue vaccine could be available by the second half of 2015, it said in a statement. The clinical trials of the vaccine were also conducted in India. According to the company's president and CEO, Mr Olivier Charmeil, "Over recent months, we have seen a worrying increase in cases in many parts of the country, putting a huge strain on healthcare systems. India is part of Sanofi Pasteur's global development strategy for dengue vaccine." "Results of CYD 15 are very encouraging and in line with the results of the phase III study results in Asia and the Phase II study results in India," he said. The company further said that the vaccine gives a 95.5 percent protection against severe dengue and an 80.3 percent reduction in the risk of hospitalisation. "We plan to submit the vaccine for licences in 2015 in endemic countries where dengue is a public health priority," he said. ]]> <![CDATA[IKMC 2014: Dr Chattopadhyay takes over as chairman]]> https://biospectrumindia.com/news/95/5397/ikmc-2014-dr-chattopadhyay-takes-over-as-chairman.html https://biospectrumindia.com/news/95/5397/ikmc-2014-dr-chattopadhyay-takes-over-as-chairman.html Wed, 05 Nov 2014 11:52:00 +0530 In his welcome speech on the day one of the IKMC 2014, Mr N Vaghul, the (former) chairman of IKP, announced that Dr Deepanwita Chattopadhyay has been appointed the chairman of the IKP with immediate effect. Mr Vaghul, who has been heading the knowledge park since its inception 15 years ago, said that the decision has been taken keeping in mind their idea of inducting young blood to the management. He will continue to be a part of the Advisory board. Commencing the two-day conference, Mr Vaghul further mentioned that he was extremely happy to see the progress made by the knowledge park and believed it was in capable hands. Dr Chattopadhyay, who was the MD and CEO of the park will continue to hold both the positions. ]]> <![CDATA[Healthcare regulator will be armed with powers, govt assures]]> https://biospectrumindia.com/news/95/5764/healthcare-regulator-will-be-armed-with-powers-govt-assures.html https://biospectrumindia.com/news/95/5764/healthcare-regulator-will-be-armed-with-powers-govt-assures.html Tue, 04 Nov 2014 16:49:26 +0530 As per Dr Harsh Vardhan, union health minister, the government would institutionalise a regulatory authority with full powers to oversee all-round quality standards enforcement and consumer protection under the NHAM. The health minister in his keynote address at a two-day National Convention on Quality in Public Health on November 04, 2014 at New Delhi stated, "NHAM is going to be the biggest ever health outreach with universal health insurance as a strong component. While quantitatively India will leapfrog into a new era, quality should not be compromised. Quality and quantity are not mutually exclusive," Dr Harsh Vardhan disclosed that the expert body headed by Prof. Ranjit Ray Choudhury had recommended that NHAM should be accountable to the people for deficiencies in delivery. That is why principles of consumer protection would come into play. Safety, Effectiveness and Positive Patient Experience would be the key points, the minister pointed out. He observed, "Why should a government facility be identified with sloth and sloppiness while a private one is identified with reliability? It is time a new culture takes over. I want to make transparency, efficiency, compassion and accountability the pillars of the public health system when NHAM is operationalised next year." Dr Harsh Vardhan remarked further, "Quality is not something abstract. It is the sum total of professionalism flowing from every branch of service. It cannot be entirely enforced from above, but should spontaneously pour from every pore of the health system. I know there is a killer instinct to excel, so please do it." The health secretary, Lov Verma, speaking at the Convention, highlighted the critical importance of institutionalising quality assurance in delivering of health service, including the service and technical/clinical quality. The Health Secretary stated that a "Medical Audit", not for punitive action, but for learning from the mistakes and correcting the system, is also need of the hour. In addition, he laid stress on regular monitoring of services through Key Performance Indicators (KPIs) which may be reviewed through field visits and review meetings. ]]> <![CDATA[Ban lifted on India: Can Argentina's pharma market outshine its rivals?]]> https://biospectrumindia.com/features/95/4509/ban-lifted-on-india-can-argentinas-pharma-market-outshine-its-rivals.html https://biospectrumindia.com/features/95/4509/ban-lifted-on-india-can-argentinas-pharma-market-outshine-its-rivals.html Tue, 04 Nov 2014 13:17:00 +0530 By 2020, its pharma market is expected to double-up touching $15 billion. Due to Argentina's local domestic policies, previously, only APIs were allowed to be imported into Argentina from India. According to a senior official who requested anonymity, for years, Argentina's pharmaceutical associations and local groups had local manufacturing interest. They lobbied many years together to maintain the competitiveness of Argentina's pharma companies and averted facing fierce competition from global pharmaceutical giants. Speaking exclusively to BioSpectrum, Mr Amarendra Khatua, Ambassador, Embassy of India in Argentina said, "Indian pharma companies have to prepare a country specific market penetration action plan to develop distribution network, identify joint manufacturing areas, specialties and facilities and setting up production bases in Argentina. Multinational firms, Argentine laboratories and established distributors are strong here. Now that India has been provided the opportunity, they have to use the existing strength of these institutions to create openings for them. Immediate exports of generic drugs will increase and this will increase interest in the market." Now along with India, other countries that are already exporting medicines into Argentina include Australia, Mexico, Brazil, Cuba, China, Chile, Finland, Hungary, Ireland, Luxemburg, Norway, and New Zealand. "This incredible policy change by Argentina, including India in the list of countries allowed to import pharmaceuticals, has become possible only due to constant persuasion by H E Ambassador of Indian Embassy in Argentina and senior officials of department of commerce, and government of India, at various levels," said Pharmaceuticals Export Promotion Council of India (Pharmexil) in a circular on its website. In 2001, Argentina faced massive financial crisis comprising of a $90 billion debt. The government later realized that the situation is not good for its manufacturing sector by keeping foreign companies at bay. The low growth of Latin American countries in 2014 was attributed to the decrease in domestic demand, and lowering external demand for commodities from China, and inadequate investments. India and Argentina are the largest importer and exporter of Argentine soy oil in the world. According to the Economic Survey issued by the UN Economic Commission for Latin America and Caribbean (ECLAC) on 4 August, 2014, the GDP growth of Latin America is likely to be 2.2 per cent declining from 2.6 per cent in 2013, 3 per cent in 2012, 4.4 per cent in 2011 and 4.7 per cent in 2010. Brazil, the largest economy in the region is likely to grow by 1.4 per cent in 2014 as against 2.5 per cent in 2013. Mexico, the second largest, is expected to grow by 2.5 per cent increasing from 1.1 per cent in 2013. Argentina, the third largest, is expected to show negative growth post technical debt default caused on July 31, 2014, as a result of failure of talks between the Argentine government and the holdout funds. Talking about the trends that may evolve as a result of this landmark decision of importing from India, Mr Khatua predicts that first there will be an increase in the interest of distributors in Indian generic drugs in Argentina. "Secondly, state controlled laboratories will express interest to get Indian partners to produce for supply and distribution in the national programmes provincial health schemes. Thirdly, there will be an interest in knowing how the existing distributors and importers could raise their profit margin by replacing imports from western markets. Already couple of Argentine Provinces have started to talk on setting up their own laboratories with Indian partners," he revealed. In Latin America, Venezuela continues to have the highest inflation at 60.9 per cent, followed by Argentina with 21.3 per cent in May 2014. According to an estimate, foreign exchange reserves are at higher levels in most Latin American countries except for Argentina and Venezuela. Brazil's reserves were $369 billion and Mexico's $191 billion in May 2014. However, Argentina's reserves worth $28 billion and Venezuela's $22 billion were much lower than the reserves of its neighbors like Peru, Colombia and Chile. According to Mr Khatua, large number of specialized Indian life sciences companies with well-developed products, and products that match the quality with lower prices are likely to gain a grip in the Argentine market. "But plenty of market development and penetration work has to be done," he expresses. "Western firms, well established distributors, defined networks and lobbies and entrenched market-related practices need to be challenged. But it will not be difficult though preparatory time is necessary." As a final piece of advice, Mr Khatua said, "Prepare to visit and know the market. Identify the niche areas. Locate suitable distributors and partners. That will help in increasing export share and future presence in the market in a bigger scale. Our help is always there." Glenmark, Cadila, and Torrent Pharma have already set up their bases in Brazil. Product registrations and approvals consume a whopping 4-7 years in Brazil and more than 2 years in Mexico. As for Argentina, it maybe too early to make any conclusions now. ]]> <![CDATA[Lupin receives FDA approval for arthritis drug]]> https://biospectrumindia.com/news/95/5121/lupin-receives-fda-approval-for-arthritis-drug.html https://biospectrumindia.com/news/95/5121/lupin-receives-fda-approval-for-arthritis-drug.html Tue, 04 Nov 2014 13:16:23 +0530 Lupin has announced that it has received approval from the United States Food and Drugs Administration (USFDA) to market generic version of GD Searle LLC's Celebrex capsules, used to treat arthritis. The company has received final approval for its Celecoxib Capsules in 50 mg strength and also received tentative approvals for its product in strengths of 100 mg, 200 mg and 400 mg. According to IMS sales data, Celebrex capsules had annual US sales of $2.44 billion. ]]> <![CDATA[Research: Diabetes drug can treat Alzheimer's]]> https://biospectrumindia.com/news/95/4261/research-diabetes-drug-can-treat-alzheimers.html https://biospectrumindia.com/news/95/4261/research-diabetes-drug-can-treat-alzheimers.html Tue, 04 Nov 2014 13:15:35 +0530 Scientists at the University of Lancaster and Ulster have discovered that two common diabetes drug lixisenatide and liraglutide have been found to work against Alzheimer's disease in a mouse model of the disease. In the study published in journal Neuropharmacology, showed that daily injections of the drugs for ten weeks brought down the levels of amyloid plaque in their brains and improved their memories and ability to recognise objects. The research could offer a potential new treatment for the disease, says the researchers. Professor Christian Holscher of Lancaster University who led the study said, "These are very exciting results. There are no drugs on the market for Alzheimer's disease that actually treat the disease, all we currently have are two types of drugs that mask the symptoms for a while. Lixisenatide and liraglutide offer a real improvement by treating the basis of the disease and, therefore, preventing degeneration." The study was funded by the Alzheimer's Society, which said that it is now funding a clinical trial of liraglutide in people with early-stage Alzheimer's disease ]]> <![CDATA[Biocon expands strategic partnership with CytoSorbents]]> https://biospectrumindia.com/news/95/5547/biocon-expands-strategic-partnership-with-cytosorbents.html https://biospectrumindia.com/news/95/5547/biocon-expands-strategic-partnership-with-cytosorbents.html Mon, 03 Nov 2014 18:28:19 +0530 The financial terms of the agreement were not disclosed. CytoSorb is used to treat patients experiencing severe whole body inflammation, often called a Systemic Inflammatory Response Syndrome (SIRS). SIRS is caused by a wide range of life-threatening conditions seen in the intensive care unit and can also be caused by surgical interventions, particularly cardiac surgery. Biocon will now have the exclusive, region-wide rights to distribute CytoSorb for all critical care applications in the intensive care unit (ICU) as well as cardiac surgery applications for India and select emerging countries. Dr Abhijit Barve, president, R&D, Biocon, said: "While our initial focus has been on sepsis, physicians are increasingly identifying conditions where very high levels of cytokines are known to cause multiple organ failure. We also believe there is a significant unmet medical need to manage high risk patients undergoing cardiac surgery by using CytoSorb to control inflammation. We are excited about working together with CytoSorbents and look forward to playing an important role in advancing the clinical development of this product." As part of the expanded agreement, Biocon will also play a prominent leadership role in the generation of new clinical evidence to support the adoption and usage of CytoSorb. This includes commitments to conduct and publish results from multiple Investigator Initiated Trials (IITs) and patient case studies. Dr Phillip Chan, CEO and president, CytoSorbents, stated: "We are very pleased to expand our relationship with Biocon, which has been an exceptional partner in launching CytoSorb in India. We take deep pride in the opportunity to potentially help more people in this part of the world by addressing a broader array of conditions...." ]]> <![CDATA[Biocon expands its partnership with CytoSorbents]]> https://biospectrumindia.com/news/95/3923/biocon-expands-its-partnership-with-cytosorbents.html https://biospectrumindia.com/news/95/3923/biocon-expands-its-partnership-with-cytosorbents.html Mon, 03 Nov 2014 18:26:17 +0530 Biocon Ltd and U.S.-based CytoSorbents Corporation have expanded the scope of their strategic partnership for CytoSorbents' CytoSorb cytokine reduction therapy to treat patients experiencing severe whole body inflammation, often called a Systemic Inflammatory Response Syndrome (SIRS). SIRS is caused by a wide range of life-threatening conditions seen in the intensive care unit and can also be caused by surgical interventions, particularly cardiac surgery. Biocon will now have the exclusive, region-wide rights to distribute CytoSorb for all critical care applications in the intensive care unit (ICU) as well as cardiac surgery applications for India and select emerging countries. As part of the expanded agreement, Biocon will also play a prominent role in the generation of new clinical evidence to support the adoption and usage of CytoSorb. This includes commitments to conduct and publish results from multiple Investigator Initiated Trials (IITs) and patient case studies. So far, the response to CytoSorb for the management of sepsis has been very encouraging with hundreds of patients in India having benefitted from this novel therapy. The expanded usage of CytoSorb in other applications could improve patient outcomes and save precious lives, said Biocon in its press statement. Mr Ravindra Limaye, President, Marketing, Biocon, said: " Our expanded partnership with CytoSorbents will now enable us to address the huge unmet needs of patients experiencing a Systemic Inflammatory Response Syndrome (SIRS) as a result of burns, lung injury, liver failure, pancreatitis, post-cardiac surgery complications, and tropical diseases like malaria and dengue fever." Dr Abhijit Barve, President, Research & Development, Biocon, said: "While our initial focus has been on sepsis, physicians are increasingly identifying conditions where very high levels of cytokines are known to cause multiple organ failure. We also believe there is a significant unmet medical need to manage high risk patients undergoing cardiac surgery by using CytoSorb to control inflammation. We are excited about working together with CytoSorbents and look forward to playing an important role in advancing the clinical development of this product." Financial terms of the agreement were not disclosed. Biocon partnered with CytoSorbents in 2013 to launch CytoSorb in India.Over the past year, Biocon has created a dedicated sales force that is solely focused on promoting CytoSorb across multiple cities in India. CytoSorb, an extracorporeal cytokine filter, has been enthusiastically embraced by physicians as a safe and well-tolerated therapy for managing sepsis in critically-ill patients. By reducing toxic levels of cytokines, CytoSorb targets the modulation of the body's excessive immune response and the prevention or treatment of organ failure, the cause of nearly half of all deaths in the ICU. ]]> <![CDATA[Steps being taken to push agri-sector to new heights: Minister]]> https://biospectrumindia.com/news/95/4075/steps-being-taken-to-push-agri-sector-to-new-heights-minister.html https://biospectrumindia.com/news/95/4075/steps-being-taken-to-push-agri-sector-to-new-heights-minister.html Mon, 03 Nov 2014 15:16:16 +0530 The Indian scientists have great potential and they can take the agriculture to a new horizon, remarked the agriculture minister, Mr Radha Mohan Singh, while delivering the key note address at 41st Foundation Day celebrations of Agricultural Scientists Recruitment Board (ASRB) on November 01, 2014. The agriculture minister complimented ASRB for its valuable contributions in selecting quality human resource for agricultural research and development. He highlighted various achievements and records of agricultural production in India emphasizing this had become possible only due to strong commitment of agricultural scientists and farmers who worked synergistically at farms and fields. He expressed satisfaction over the transparent process of recruitment that has earned credibility for the ASRB and urged to completely digitize the entire procedure to ensure further transparency. Agriculture minister stressed upon various new initiatives being taken by the government to push up Indian agriculture further to new heights including over all development of villages to bring prosperity. Singh said steps are being taken to strengthen infrastructure of the KVKs spread across the country including significant increase in their numbers. Citing various examples, he expressed happiness over adoption of scientific and technological interventions at grass root level. Agricultural minister released inaugural issue of the ASRB News (Hindi and English) and ASRB Profile (bilingual). Dr S Ayyappan, secretary, DARE and DG, ICAR complimented ASRB for its achievements and glorious journey of four decades in bringing excellence to agricultural research system. He highlighted some of the key steps to ensure speedy recruitment of agricultural scientists maintaining high quality and transparency. Dr J S Samra, CEO, National Rainfed Area Authority, government of India recalled the conditions in which ASRB was constituted and expressed his satisfaction over the performance of ASRB in view of its mandate and objectives. He made suggestions to further improve the services of ASRB for over all development of agricultural research in the country. Earlier, Dr Gurbachan Singh, chairman, ASRB welcomed the chief guest and dignitaries and highlighted some of the significant achievements including new initiatives. Transformation from pen and paper examination to Computer based test for ARS-Preliminary and NET is one of the recent pioneer steps taken by the ASRB to upgrade and advance talent search, he added. In the technical session, Prof. RaghavendraGadagkar, President, INSA delivered the Foundation Day Lecture on, 'War & Peace: Conflict & Cooperation in an Insect Society'. He underlined the infinite potential and critical linkage of scientific endeavors to national development. Prof. Gadagkar elaborated upon social behavior and structure of some of the insects based on his own research experiences in a lucid and interesting manner. ]]> <![CDATA[Utilize agri-technology for zero hunger agenda: Report]]> https://biospectrumindia.com/news/95/5278/utilize-agri-technology-for-zero-hunger-agenda-report.html https://biospectrumindia.com/news/95/5278/utilize-agri-technology-for-zero-hunger-agenda-report.html Mon, 03 Nov 2014 15:13:44 +0530 "New frontiers of the mind and technology are before us, and if they are pioneered with the same vision, boldness and drive with which the battle against food shortage was fought through the green revolution, we can achieve the goal of Zero Hunger sooner than generally considered possible," said Professor M S Swaminathan who released recommendations, included in an action agenda for nutrition security, on October 31, 2014. The recommendations are based on a review of the current evidence and approaches to achieve nutrition security in India. A similar document entitled "Sustainable Nutrition Security in India: A Leadership Agenda for Action" was originally released by the Coalition in 2010; this document updates the evidence and calls for specific areas of action for national and state-level actors. These areas of action are urgent to enable accelerated movement in India's poor nutrition statistics. The action agenda calls for five top areas of action. That includes the following: Institutionalize leadership for nutrition within the prime ministerial and chief ministerial offices; Prioritize universal coverage of selected evidence-informed essential nutrition interventions, with a special focus on children under two years of age, pregnant women and adolescent girls;Finance and deliver at scale the essential nutrition interventions with active attention to equity; Ensure equitable access to food security, including dietary diversity, primary health care, safe drinking water, environmental and household sanitation and address gender issues pertaining to women's education and delaying age of conception; Position nutrition as a development indicator and establish a reliable system for periodic data-driven updates on the state of nutrition in India. One of the important recommendations in the report suggets that a proper fusion of political will, scientific skill and people's participation can help to reduce the malnutrition problem sooner than most people feel possible. "The Coalition has identified several urgent areas for action. They are all important, but two in particular stand out for me positioning nutrition as a development indicator of the highest order, with frequent and regular data collection and positioning accountability for nutrition within the Prime Minister's Office. Malnutrition is too easily ignored with little accountability on commitments made--these two recommendations, if taken up, will not allow that to happen," observed Professor Lawrence Haddad. Dr Laxmikant Palo, senior advisor - Nutrition, Save the Children, said, "In order to compliment the goals of Coalition for Food and Nutrition Security in India, the recommendations will be taken forward from this report and will be implemented at state levels by Save the Children". ]]> <![CDATA[TB battle: Eli Lilly transfers technology to companies ]]> https://biospectrumindia.com/news/95/4726/tb-battle-eli-lilly-transfers-technology-to-companies-.html https://biospectrumindia.com/news/95/4726/tb-battle-eli-lilly-transfers-technology-to-companies-.html Mon, 03 Nov 2014 12:56:35 +0530 Eli Lilly has published details of its long-standing technology transfer program to increase the global supply of medicines for multidrug-resistant tuberculosis (MDR-TB). Begun in 2003, the effort included Lilly donating manufacturing technology and know-how for two antibiotics to pharmaceutical manufacturers in China, India, Russia and South Africa - all MDR-TB 'hot spots.' It also served as the foundation for the Lilly MDR-TB Partnership, the company's largest-ever philanthropic effort. The technology transfer was Lilly's response to a dramatic global rise in MDR-TB cases in the late 1990s and early 2000s. Until that time, Lilly manufactured and supplied nominal quantities of two TB medicines - capreomycin and cycloserine. After independent researchers found that these two TB medicines were also effective in treating drug-resistant TB, Lilly doubled production and subsidized prices of the medicines. However, global demand was projected to quickly outpace manufacturing capacity, and Lilly sought a longer-term solution for people needing these medicines. After close consultation with global TB experts, Lilly embarked on a novel approach: transferring its manufacturing technology and know-how for capreomycin and cycloserine free of charge to seven manufacturers in four countries. In India, the technology transfer of second line drug cycloserine has been completed with Shasun Chemicals and Drugs, Chennai. "We thought bigger," commented Dr John Lechleiter, Lilly's chairman, president and chief executive officer, in a video about the decision to undertake the technology transfer. "I am very proud of the fact that we looked beyond the question of can we supply these medicines. With a lot of Lilly people contributing their time and talents and working with multiple partners, it's been an extraordinary story and an extraordinary accomplishment." "Sustainable access to quality-assured medicines has been our aim throughout this long initiative," said Dr Evan Lee, vice president of Lilly's Global Health Programs. "All seven of our partners have received regulatory approvals, including those from the World Health Organization's prequalification program and other stringent regulatory authorities, to supply high quality versions of these two medicines to people with MDR-TB." . ]]> <![CDATA[HLL Lifecare to step its activities across India]]> https://biospectrumindia.com/news/95/3991/hll-lifecare-to-step-its-activities-across-india.html https://biospectrumindia.com/news/95/3991/hll-lifecare-to-step-its-activities-across-india.html Mon, 03 Nov 2014 12:55:00 +0530 The store that was opened on November 01, 2014 in Goa's capital city is the first in a chain of retail pharmacy outlets branded "GAPL Medicentre" to be set up in hospitals and public places in the state. HLL chairman and managing director Dr M Ayyappan said GAPL is in the process of scaling up its operations by supplying pharmaceutical products across the country. GAPL has been successfully operating 24X7 pharmacy outlets in major government hospitals in Goa for more than a decade; this is the first store to operate in a public place. The uniqueness of GAPL is being 'holistic'. It offers a range of medicines across Allopathic, Homeopathic, Ayurvedic, Siddha and Unani medical practices. Located in the village of Tuem, Pernem in North Goa, GAPL provides employment to around 300 people in the locality. The company is targeting multi-fold growth in the next couple of years. HLL acquired a 74 per cent equity stake in GAPL from the Government of Goa in March 2014. The Mini Ratna public sector enterprise under the ministry of health and family welfare, has already made its presence felt in the pharma industry by offering a basket of women's healthcare products. It has a strong distribution network, reaching out to over 30,000 medical professionals and over 3,500 hospitals in the country. "We are enhancing the pharma manufacturing capabilities of GAPL to cater to the market potential. This is in tune with our diversification plans across the health segment, including project management consultancy, manufacture of vaccines, establishment of diagnostic centers and generic medicine outlets," said Dr Ayyappan. ]]> <![CDATA[Can GSK's verdict rewrite product strategies in developing markets?]]> https://biospectrumindia.com/features/95/4693/can-gsks-verdict-rewrite-product-strategies-in-developing-markets.html https://biospectrumindia.com/features/95/4693/can-gsks-verdict-rewrite-product-strategies-in-developing-markets.html Mon, 03 Nov 2014 12:53:05 +0530 GSK in an official apology statement has confessed that it '...fully accepts the facts and evidence of the investigation, and the verdict of the Chinese judicial authorities.' The breach came to light after an investigation that was launched following allegations from a whistleblower revealing the practices in GSK's Chinese operations. While bribing controversies is not a new thing among the big pharma giants, globally, industry analysts now feel that the impact of this judgment could have far reaching consequences with respect to strategy shift in new product marketing. "Pharma companies will be much more cautious in their approach to recruiting and incentivizing medical professionals, especially physicians in emerging markets," predicts Ms Aparna Krishnan, MS, analyst, GlobalData, who covers the dynamics of healthcare industry. In the past, large pharmaceutical companies looking to expand their presence in emerging markets have traditionally used third parties to carry out promotional activities for their therapies. "Now companies will be more aware of prohibition around certain practices, and may instead look to partner with more established domestic companies in order to build up their presence in the Asian markets. We have seen this historically with the Japanese market, where out-licensing remains a key feature of the commercialization strategy," explains Ms Aparna. Now pharma companies are eyeing emerging markets in countries life Middle East, Africa, and APAC countries. Simultaneously, pharmaceutical marketing is intensifying in these markets as companies attempt to build market share across untapped patient populations. Ms Aparna also believes that there will be increased scrutiny from regulatory authorities in emerging markets over certain practices employed by companies to strengthen their commercial positions in these areas. Companies will be increasingly conscious of the potential fallout from some of these practices, and will need to be more structured and open in their approach in building brand awareness. Conversely, corruption remains an issue in many emerging economies, not limited to the pharmaceutical industry. Market barriers will be difficult to overcome without concerted efforts across the corporate landscape and relevant governing bodies to improve market access. Now how will this verdict affect countries like India, for example? Experts opine that Indian health authorities will increasingly scrutinize the incentives and payment structures involving physicians and big pharma firms. Any evidences with corrupt practices is likely to attract stringent punishment. The other major pharma players in the APAC market include Novartis, AstraZeneca, Roche, Sanofi, Merck, and Eli Lilly. "This verdict will force the reassessment of certain marketing strategies in these countries, primarily compensation for physicians and hospital personnel when promoting pharmaceutical products," opines Ms Aparna. ]]> <![CDATA[New guideline compounds complexity to clinical trials]]> https://biospectrumindia.com/features/95/7514/new-guideline-compounds-complexity-to-clinical-trials.html https://biospectrumindia.com/features/95/7514/new-guideline-compounds-complexity-to-clinical-trials.html Mon, 03 Nov 2014 12:48:19 +0530 According to the new order, organizations wanting to carry out clinical trials in India need to justify how the country would benefit from the trial. The companies are expected to provide details on the following three parameters: Risks vs Benefits to the patients Innovation vis-Ã -vis existing therapeutic options Unmet medical needs in the country "Obviously drug innovation is about addressing unmet medical needs and improving medical outcomes. However, it is not possible to guarantee or predict therapeutic benefits of a molecule before the clinical development process is completed. For example, we got a 'placebo effect' when we conducted trials on our oral insulin molecule IN105, but the therapeutic intent was powerful," expressed Dr Kiran Mazumdar-Shaw, CMD, Biocon. Clinical trials are an indispensable part of drug discovery and development research, and it is at the heart of all medical advances, offering hope for millions of patients, and an opportunity to help researchers find better treatments for future generations. Moreover, companies can also learn a great deal from the trial data, instilling confidence to pursue a particular molecule. "No company will try and develop a new drug if it does not bring benefit. Thus, this mandate is both unnecessary and completely redundant. It sounds like a meaningless bureaucratic barrier created to deter clinical trials and scripted by a 'babu' who does not understand drug innovation! Such mandates will stall and delay approvals and only encourage pharma companies to conduct clinical trials in other parts of the world. This will be a huge setback not just for Indian innovators but more importantly for Indian patients," explained Dr Kiran. However, on the other hand, Dr Suresh Menon, executive committee member, Indian Society for Clinical Research (ISCR) does not see any impact by the new order. "This has been in practice for around a year now and so this is not something new. What the recent order has done is to pass that responsibility onto the sponsors of clinical research. While the assessment of risks vs benefits to patients and details on innovation vis-Ã -vis existing therapeutic options are factors that every trial must take into consideration whether a legal requirement or not. The details of whether the investigational product meets an unmet medical need in the country is open to interpretation. Ideally it should be the regulators who should evaluate these parameters based on clearly defined guiding principles," Dr Menon added. Commenting on the parameters, Dr Kiran asks, isn't it common sense that drug innovation considers most of these criteria? "I'm concerned about how the term 'unmet medical needs' is being defined. Unmet needs, for example, can range from affordability to new therapies. Unless defined clearly, such a parameter can end up creating confusion and disincentivize pharma companies from conducting trials in India," she warned. She also pointed out another serious concern on the stipulation of restricting clinical trials to 3 per investigator. "This is absurd given that we have a shortage of clinical investigators in India. In fact, most investigators in the US or Europe are engaged in a far larger number of clinical trials at any given time. This mandate will only serve to restrict drug innovation," opined Dr Kiran. Dr Menon believes, "As long as there is clarity and guidance provided ensuring decisions are objective, having patients interest and safety and the larger healthcare requirements of our country in mind, we do not believe these orders will affect clinical research in India. There are some biopharma companies who believe it could act as a disincentive, but it is too early to comment specifically," he voiced. Conversely, Dr Kiran feels that the new guidelines will only add to the complexity of the trial process, proving to be counter-productive. She opined, "The ongoing clinical trials controversy has already severely hampered drug development in India. The concerns around ethics and safety pertained only to a few trials, but the entire sector has had to pay the price." Parallelly, for the online filing of returns for the monitoring or revising of drug prices, the National Pharmaceutical Pricing Authority (NPPA) has asked pharmaceutical companies to register under Integrated Pharmaceutical Database Management System (IPDMS). The use of IPDMS is seen as a favorable move by NPPA thereby increasing transparency. "However, the NPPA can improve the drug pricing exercise by consulting stakeholders before issuing new price orders. Moreover, it is unfair to compare prices of drugs manufactured by large, reputed manufacturers with those made by SMEs. Investments made by large players in ensuring high quality standards need to be considered when calculating price ceilings," In May this year, the NPPA also came up with a new guideline allowing it to have the power and control over drug prices. However, now the Authority has withdrawn this guideline brining back cheers to the pharma world. "Very few of our products fall into the new list of products put under price control, hence there will be a very marginal impact. Having said that, it is heartening to see that the NPPA has withdrawn the controversial guideline that gave it sweeping powers to set the price of even those drugs that are outside the National List of Essential Medicines (NLEM). It will be in the interests of all concerned, if NPPA stops acting unilaterally and consults all stakeholders before taking a decision," said Dr Kiran Mazumdar. ]]> <![CDATA[Bombay HC approves Pfizer-Wyeth deal]]> https://biospectrumindia.com/news/95/5624/bombay-hc-approves-pfizer-wyeth-deal.html https://biospectrumindia.com/news/95/5624/bombay-hc-approves-pfizer-wyeth-deal.html Mon, 03 Nov 2014 12:48:00 +0530 The Mumbai High Court (HC) has approved the merger of Wyeth with the pharma giant Pfizer. "The Honorable High Court of Judicature at Mumbai has considered and approved the amalgamation of Wyeth with the company," the company said in a filing to BSE. Last year, Pfizer and Wyeth had said that they will merge their India operations under a single brand, 'Pfizer brand' as a part of efforts to boost business. ]]> <![CDATA[Malaria research receives Bill Gates support]]> https://biospectrumindia.com/news/95/4967/malaria-research-receives-bill-gates-support.html https://biospectrumindia.com/news/95/4967/malaria-research-receives-bill-gates-support.html Mon, 03 Nov 2014 12:47:16 +0530 Philanthropist Mr Bill Gates has announced that he will donate over $500 million to fight malaria and other infectious diseases in the developing world, saying the Ebola outbreak is a call to action. According to reports, Gates Foundation is committing more than $500 million to reduce the burden of malaria, pneumonia, diarrheal diseases, and an array of parasitic infections that are leading causes of death and disability in developing countries. The money announced includes over $150 million to the PATH Malaria Vaccine Initiative to advance development of next-generation malaria vaccines, and $29 million to the Clinton Health Access Initiative to support malaria elimination efforts in Southern Africa and the Southeast Asia. "The rise in resistance to effective malaria drugs in Southeast Asia should serve as a warning, that better research and development is needed to stay ahead of the natural evolution of infectious diseases," Mr Gates said. He added, "What is needed are single-dose complete cures for malaria, more sophisticated diagnostics and a next-generation malaria vaccine, as well as more widespread and precise use of bednets." He further added that eradicating malaria by the middle of this century is both a necessary objective and an attainable one. "We must remain committed to the eradication of malaria," he said. ]]> <![CDATA[India to eradicate TB by 2020]]> https://biospectrumindia.com/news/95/5190/india-to-eradicate-tb-by-2020.html https://biospectrumindia.com/news/95/5190/india-to-eradicate-tb-by-2020.html Sun, 02 Nov 2014 11:36:00 +0530 Highlighting the government's plans to eliminate Tuberculosis (TB) from the country Union Health Minister Mr Harsh Vardhan announced the 'TB-Mission 2020', at the recent WHO's Global TB Symposium. TB is one of the biggest health problems in the country, killing 1,000 people daily. "While I am all for having a long-term perspective, I am not interested in something that may or may not be achieved in 2035 or 2050. I have instructed anti-TB mission officials to work hard to achieve considerable success over the next five years under the evolving 'TB-Mission 2020'," Mr Harsh Varadhan said in a statement. He added further that efforts are being taken by the government to provide free diagnosis and treatment as well as nutrition support and relevant financial enablers to the patients from government and private hospitals. He further emphasised that the solution to lung-related health challenges lies in bringing together all the stakeholders, namely, the health care professionals, policy makers, and the communities they serve. "That is why we are intent on developing a large social movement over health," he concluded. ]]> <![CDATA[Research: Stem cell to kill cancer cells]]> https://biospectrumindia.com/news/95/5562/research-stem-cell-to-kill-cancer-cells.html https://biospectrumindia.com/news/95/5562/research-stem-cell-to-kill-cancer-cells.html Sun, 02 Nov 2014 11:35:00 +0530 Scientists at Harvard Stem Cell Institute (HSCI) have discovered a novel way to fight the deadly brain cancer with toxin-resistant stem cells. The research was led by Indian-origin Scientist Dr Khalid Shah. It could pave the way for a new class of cancer treatment. In experiments on mice, the stem cells were genetically engineered to produce and secrete toxins which kill brain tumours, without killing normal cells or themselves. "A few years ago, we recognised that stem cells could be used to continuously deliver these therapeutic toxins to tumours in the brain, but first we needed to genetically engineer stem cells that could resist being killed themselves by the toxins," said Dr Khalid Shah, lead author and director of the molecular neurotherapy and imaging lab at Massachusetts General Hospital and Harvard Medical School. He added, "Now, we have toxin-resistant stem cells that can make and release cancer-killing drugs." During the tests, the main brain tumour was surgically removed before the stem cells were placed at the site of the tumour in a biodegradable gel to eradicate the remaining cancerous cells. The researchers now plan to test the technique using a number of different therapies on mice with glioblastoma, the most common brain tumour in human adults. Dr Shah predicts that clinical trials with the therapy will begin within the next five years. ]]> <![CDATA[Govt to announce free glucose test for all]]> https://biospectrumindia.com/news/95/5290/govt-to-announce-free-glucose-test-for-all.html https://biospectrumindia.com/news/95/5290/govt-to-announce-free-glucose-test-for-all.html Sun, 02 Nov 2014 11:05:00 +0530 The Indian government is considering the conduction of a free glucose test for the entire Indian population, as the disease has almost assumed epidemic proportions in the country. The idea behind this nation-wide campaign is to facilitate earlier detection of the disease, thus easing disease management and reducing the risk of complications. The Science and Technology Minister, Dr Jitendra Singh, said in a recent press conference, "Millions of Indians suffer from diabetes and a plan to arrange for free glucose test for the entire population is under consideration. Screening is crucial as we are number two in the world in terms of diabetes sufferers after China." Statistics state that India has 67 million diabetes cases while China has about 92 million. It is estimated that by 2030, India will have around 100 million diabetes patients and could surpass even China. Dr Singh stated that many academic and government institutions in India are focusing on chronic ailments and their cure. He mentioned that research on genetic and stem cells, supported by the Department of Biotechnology, could be an answer to diseases such as diabetes. The government had recently announced many plans to foster the development of healthcare and to promote health and wellness in the society. These included plans to launch the flagship National Health Assurance Mission which would comprise of assured health packages, including essential drugs and diagnostics. Under this mission, the poor are likely to get the treatment free of cost and the rest of the population are expected to be covered under an insurance mechanism. A package of preventive and positive health information will also be made available to all citizens, with the health insurance scheme being a built-in feature of the mission. ]]> <![CDATA[India and Scotland tie up for research]]> https://biospectrumindia.com/news/95/5572/india-and-scotland-tie-up-for-research.html https://biospectrumindia.com/news/95/5572/india-and-scotland-tie-up-for-research.html Sat, 01 Nov 2014 11:32:00 +0530 Scottish development International, the international arm of Scottish Enterprise, has inked two strategic pacts between Scottish and Indian Universities. These include agreements between University of Dundee and Bangalore BioCluster; and the Scottish Association for Marine Science (SAMS) with Annamalai University and AMET University, for research in lifesciences and marine biotechnology respectively. University of Dundee signed a Memorandum of Understanding (MoU) with Bangalore BioCluster to create a joint Drug Discovery Center. They will tackle antimicrobial resistance. The Drug Discovery center will focus on effective prevention and treatment of the ever increasing range of infections caused by bacteria, parasites, viruses, and fungi, hospital-acquired infections and in major diseases such as tuberculosis and malaria. SAMS also exchanged a MoU with Annamalai University and AMET University to cooperate more closely in education and research. SAMS, a partner of the University of the Highlands and Islands and of the United Nations University aims to develop faculty, student and knowledge exchange programs, co-supervised PhDs, and joint research projects. SAMS' collaboration with Annamalai university will focus on developing knowledge and skills for sustainable management of the coastal environment, including aquaculture. With AMET University, the focus will be on marine biotechnology and microbiology. Mr Joanne Allday, marketing manager, Education at SAMS, said, "The exchange of information and funding is now being sought to support faculty and student exchanges, to develop long-lasting relationships for the future." ]]> <![CDATA[Alembic Pharma buys 49% stake in Algeria's Adwiya Marni]]> https://biospectrumindia.com/news/95/3918/alembic-pharma-buys-49-stake-in-algerias-adwiya-marni.html https://biospectrumindia.com/news/95/3918/alembic-pharma-buys-49-stake-in-algerias-adwiya-marni.html Sat, 01 Nov 2014 11:08:00 +0530 Alembic Pharmaceuticals 100% subsidiary Alembic Global Holding (AGH) announced the joint venture deal with Adwiya Marni SARL Algeria. The deal envisages investment by AGH to the extent of 49 percent equity of Adwiya Marni. Post conclusion of deal the company will be renamed as Alembic Marni SPA. Adwiya Marni owns a state of art formulation plant with a capacity of 1.2 billion per annum oral solids. The plant has been designed and developed by a leading European Pharmaceutical company in line with the cGMP requirements. The plant has enough headroom for future expansion. The investment in Adwiya Marni will give AGH a quick entry to the attractive Algerian market. Algeria is a large African market with a size of $3 billion (70 percent Generics, 30 percent Innovator). There are entry barriers and the local manufacturing units get a distinct advantage in marketing the products, said the company in a press release. Imports are prohibited once there is a local manufacturing. The company will be jointly run by Alembic and Marni with equal representation from both in the Board. Ms Tagreed Alshunar, a Jordanian national and professional with an experience over 20 years in the pharma Industry has been appointed as the first CEO of the Company. She will be the nominee of Alembic. ]]> <![CDATA[Warburg Pincus invests Rs 550 crore in Laurus Labs]]> https://biospectrumindia.com/news/95/4966/warburg-pincus-invests-rs-550-crore-in-laurus-labs.html https://biospectrumindia.com/news/95/4966/warburg-pincus-invests-rs-550-crore-in-laurus-labs.html Fri, 31 Oct 2014 15:55:07 +0530 The terms of the transaction were not disclosed. Warburg Pincus is a global private equity firm focused on growth investing. It will join Fidelity Growth Partners India (FGPI) and Boston-based Fidelity Biosciences, who led an earlier round of investment in 2012, as an investor in the company. Dr Satyanarayana, founder and CEO, Laurus, said, "Laurus is at an important juncture in its evolution... We are glad to partner with Warburg Pincus in this phase of our growth where we will seek to continue the thrust on innovation and manufacturing excellence in offering cost-effective products and services and foraying into new business segments. In addition to securing growth capital, we look forward to leveraging Warburg Pincus' deep domain expertise and global network of relationships to help enter new markets and add to our customer base." Laurus also has a presence in nutraceuticals and several other products, with a customer base that spans top-tier generic pharmaceutical companies in India and abroad. In addition to the API business, the company has a fast-growing contract manufacturing business that caters to several generic and innovation-driven, global pharmaceutical companies. Commenting on the transaction, Mr Niten Malhan, managing director and co-head, Warburg Pincus, said, "This investment reflects Warburg Pincus' core philosophy of partnering with distinctive management teams to create durable businesses of scale with sustainable value." The company has grown rapidly since its first full year of commercial operations in 2008, recording revenues of around Rs 1,200 crore in FY2013-14. Mr Raj Dugar, senior MD, FIL Capital Advisors (India), the private equity advisory arm for FGPI, said "Through a positive combination of technical depth, relentless execution and highest level of corporate governance, the team at Laurus Labs has built a market-leading pharmaceutical company in a short span of time. We are excited to continue our partnership with the company, and welcome Warburg Pincus to join this exciting growth story." Jefferies acted as the sole financial advisor in this transaction. ]]> <![CDATA[Price competition to impact Sanofi's diabetes drug sales]]> https://biospectrumindia.com/news/95/5541/price-competition-to-impact-sanofis-diabetes-drug-sales.html https://biospectrumindia.com/news/95/5541/price-competition-to-impact-sanofis-diabetes-drug-sales.html Fri, 31 Oct 2014 11:31:00 +0530 Sanofi's CEO, Mr Christopher A Viehbacher commented, "We are pleased with our performance in the third quarter. We achieved solid Business EPS growth driven by continued strong contribution from our growth platforms, allowing us to confirm 2014 outlook. Growth platforms reached over 78 percent of sales and grew 10 percent. We have recently seen a more challenging US diabetes price environment which will impact our diabetes sales throughout 2015, while growth platforms globally are expected to continue to show solid growth. At the same time, our pipeline delivered strong results, with the release of exciting Phase III data for alirocumab and our Dengue vaccine, the entry of dupilumab in Phase III as well as the FDA approval of Cerdelga and the licensing of Afrezza." Solid sales and business EPS(1) growth at CER in the third quarterâ€¢ Group sales up 5.1% to â‚¬8,781 millionâ€¢ Growth platforms increased 10.0 percent to â‚¬6,862 million, representing 78.1 percent of total salesâ€¢ Business net income grew 9.4 percent at CER to â‚¬1,935 million (+7.8 percent on a reported basis)â€¢ Business EPS increased 10.3 percent at CER to â‚¬1.47 Steady sales increase in growth platformsâ€¢ Diabetes grew 8.3 percent to â‚¬1,799 million despite increased price competition in the USâ€¢ Vaccines sales grew 11.2 percent driven by strong performance of flu vaccine and progressive supply recoveryâ€¢ Genzyme continued to deliver with sales growth of 24.6 percentâ€¢ Animal Health grew 12.7 percent due to strong sales in the US market Significant advances in bringing new medicines to marketâ€¢ Cerdelga, the only oral therapy for adult Gaucher disease type 1 patients, approved in the USâ€¢ Detailed results from four pivotal Phase III alirocumab trials presented at the ESC congressâ€¢ Final landmark Phase III efficacy study in Latin America for Dengue vaccine successfully completedâ€¢ Dupilumab, an investigational therapy for moderate-to-severe atopic dermatitis, entered Phase IIIâ€¢ Investigational rotavirus vaccine for Emerging Markets entered Phase III â€¢ Global licensing agreement announced for Afrezza, a new rapid-acting inhaled insulin Financial guidance for 2014 confirmedâ€¢ 2014 business EPS is expected to be between 6 percent to 8 percent higher than 2013 at CER, barring major unforeseen adverse events ]]> <![CDATA[Glenmark's consolidated revenue 14.85% up ]]> https://biospectrumindia.com/news/95/3578/glenmarks-consolidated-revenue-14-85-up-.html https://biospectrumindia.com/news/95/3578/glenmarks-consolidated-revenue-14-85-up-.html Fri, 31 Oct 2014 11:14:00 +0530 Business Highlights â€¢ India Business grew by 14.48 percent to Rs 4,781.50 Mnâ€¢ Latin America Business grew by 139.01 percent to Rs 2,308.80 Mnâ€¢ Europe Formulations Business grew by 25.06 percent to Rs 1,305.53â€¢ API Business grew by 57.85 percent to Rs 1,595.44 For the second quarter, Glenmark's consolidated revenue was at Rs 16,807.08 mn ($277.50 mn) as against Rs 14,633.80 mn ($235.68 mn) an increase of 14.85 percent. The consolidated Net Profit for the second quarter was Rs 1650.78 mn as compared to Rs 1542.97 mn for the previous corresponding quarter, recording an increase of 7 percent. Consolidated EBITDA grew by 6 percent to Rs 3352.22 mn from Rs 3156.81 mn in the quarter. "Despite the challenging environment, we have performed well across geographies viz India, Europe and LatAm. The environment continues to be tough especially in the US where product approvals have slowed down considerably and the channel consolidation has impacted overall sales," said Mr Glenn Saldanha, CMD, Glenmark Pharmaceuticals. "We have made significant progress in our innovation pipeline, the highlight being the discovery and the Initiation of IND enabling Studies of GBR 1302, the first bispecific antibody based on Glenmark's proprietary BEAT platform and our first clinical candidate targeting oncology indications," he added. For the six month ended Sep 30, 2014, Glenmark's consolidated revenue was at Rs 31,676.48 mn as against Rs 27,016.23 Mn, an increase of 17.25 percent over the previous corresponding period. India FormulationsSales for the formulation business in India for the second quarter ended September 30, 2014, was at Rs 4,781.50 mn ($78.98 mn) as against Rs 4,176.80 mn ($67.51 mn) in the previous corresponding quarter, recording a growth of 14.48 percent. USA FormulationsGlenmark Generics Inc., USA registered revenue from sale of finished dosage formulations was Rs 5,075.51 Mn ($83.76 mn) for the quarter ended September 30, 2014 against revenue of Rs 5,578.60 mn ($90.09 mn) for the previous corresponding quarter. Africa, Asia and CIS Region (ROW) For the second quarter, revenue from Africa, Asia and CIS region was Rs 1,740.30 Mn ($28.67 mn) as against Rs 1,739.65 mn ($26.70 mn) for the previous corresponding quarter. Europe FormulationsGlenmark Europe's operations revenue for the second quarter ended September 30, 2014 was at Rs 1,305.53 mn ($21.57 mn) as against Rs 1,043.90 mn ($16.97 mn) recording growth of 25.06 percent. Latin AmericaGlenmark's revenue from its Latin American and Caribbean operations was at Rs 2,308.80 Mn ($38.21 mn) for the second quarter ended September 30, 2014 as against Rs 966.00 mn ($15.50 mn), recording an increase of 139.01 percent. Active Pharmaceutical Ingredients (API)Revenue from sale of API to regulated and semi-regulated markets globally was Rs 1,595.44 mn ($26.34 mn), for the quarter ended September 30, 2014 against Rs 1,010.75 mn ($16.92 mn) for the previous corresponding quarter, recording an increase of 57.85 percent. ]]> <![CDATA[India looks at immunization as best savior!]]> https://biospectrumindia.com/news/95/5372/india-looks-at-immunization-as-best-savior.html https://biospectrumindia.com/news/95/5372/india-looks-at-immunization-as-best-savior.html Fri, 31 Oct 2014 10:48:00 +0530 Complete immunization remains high on the agenda of the union health minister, Dr Harsh Vardhan as he points out the fact that lakhs of young children die of preventable diseases every year in India. The Minister is right when he rues that even 29 years after the launch of the immunisation program, only 65-70 percent of the children get immunized. "One important aspect of meeting healthcare challenges is to focus on preventive and positive healthcare, in which immunization plays a big role," Dr Vardhan said at an event in Delhi, adding further, "I believe we can achieve anything if we put our heart into it. The eradication of polio from India, once considered an impossible task, is an excellent example. There is goodness in every person's heart. We need to leverage that and make every Indian a stakeholder in good health. I assure you that the government is very serious about achieving total immunization in India, and whatever it takes, we are determined to achieve this goal." The recent introduction of four new vaccines in the universal immunization programme (UIP) is being labelled as major accomplishment. The inclusion of injectable polio vaccine (IPV) is expected to aid in complete elimination and achieving the zero virus targets, not possible earlier in case of oral polio vaccine due to the live nature of virus. Similarly, the new Rubella vaccine with high efficacy will not only control Rubella but Measles as well. Hence, it is the elimination of two diseases at no extra cost. While the Japanese Encephalitis was already existing in immunization program but now coverage is being extended to adults due to increased number of cases being reported. Rotavirus vaccine is considered to be a major achievement to contain diarrhoea although experts lay onus also on sanitation and better hygiene too. It is said that estimated 50,000 deaths could be averted just by rolling rotavirus immunization. As per India Infrastructure Report 2013-14, currently only 11 percent of the vaccines in India are a part of the UIP while 65 percent constitute the non-UIP vaccines. Rabies vaccine and sera/globulins account for 12 and 10 percent respectively. Hence, there exist a lot many opportunities for the companies to collaborate with the government agencies to produce affordable yet profitable vaccines. DBT at the forefront "Over a period of time, the vaccine industry in India has grown enormously, with international experience and has set up state of art vaccine manufacturing units with WHO pre-qualified standards and supplying vaccines to various countries in the world," said Dr TS Rao, senior advisor, Department of Biotechnology (DBT). The department has implemented a program to develop vaccines through a National Jai Vigyan Mission Program on Science and Technology for generation of new and improved vaccines since 1988-89. Several vaccine candidates are in pipeline and some of them have entered into pre-clinical and clinical trial stages. Many of them are being developed with rota model such as dengue, malaria and tuberculosis. Added Dr Rao, "It is a well-known that the time taken from discovery to delivery of new vaccines can take more than a decade. During this developmental process several constraints need to be met towards scientific, technical and regulatory hurdles before these will be put into regular immunization program. DBT has initiated Vaccine Grand Challenge Program, implemented since 2009-10, with an aim to develop affordable, effective vaccines, adjuvants and vaccine delivery technology and to facilitate clinical development consistent with highest ethical and regulatory standards." Dr MK Bhan, former secretary, DBT felt that in terms of fulfilling the requirements of poor, the vaccine industry has done outstanding job. "In 2012-13, 7-8 vaccines have been commercialized. It has brought relief to sufferers. Earlier it used to be pharma but now Indian vaccine industry is being admired," he told BioSpectrum in an interaction few months back. Target specific populations for better outcomes The National Family Health Survey 2005-06 has revealed huge gap in immunization coverage in between urban and rural areas. An analysis of the immunization coverage in 2005-06 also brought forth the rampant inequalities based on gender, regions and socio-economic groups of people. Whereas less than 40 percent of all children in rural areas were immunised, the urban coverage was 58 percent. A study spearheaded by the Public Health Foundation of India (PHFI) has concluded that improving immunization coverage and the introduction of a rotavirus vaccine significantly alleviates disease and financial burden in Indian households. As per report, India has the highest under-five death toll globally, approximately 20 percent of which is attributed to vaccine-preventable diseases. It also points to the fact that the population subgroups or regions with low existing immunization coverage benefit the most from the intervention. Therefore, the authors of the study report of 'Analysis of Universal Immunization Program and introduction of rotavirus vaccine in India with Indiasim' have suggested that increasing coverage by targeting those subgroups alleviates the burden more than simply increasing coverage in the population at large. As per Dr Ramanan Laxminarayan, vice president-policy and research, PHFI, the major highlight of the study is that the hospitalization could be averted and impact of rotavirus vaccine will be ainly on preventing deaths and saving medical costs." "However, the limitations remain with system challenges, cost, and health improvement," he added quickly. Scaling up immunization by targeting regions with low coverage averts a slightly higher number of deaths and expenditure. Vaccines have an edge over drugs?"Prevention is better than cure", is the message that has been handed over to us since generations. The need for drugs comes when there is a failure of body system due to breakdown of immune system. Hence, the vaccination as an attempt to prevent that failure surely is a huge boost to a great extent.Agreeing with the fact, Dr Davinder S Gill, CEO, Hilleman Laboratories felt that life style diseases too might be prevented but should not be a priority right now. Instead he believes that the vaccines are more required for the children. "Rightly so, the government has identified the need to create healthy generation of children by vaccinating on time. Of course, drugs are going to be important but government has recognized the importance of vaccines for the elimination of need to take drugs at a later stage, thereby lowering the disease burden," said Dr Gill. According to Dr Jacob John, senior professor, Christian Medical College, Vellore, "There are two avenues to build on success and one is to target more diseases such as measles and rubella as they fulfill criteria after polio. The second is to build upon our health management system so as to control many neglected diseases such as TB, malaria, typhoid fever or those that have failed to come under control. Some like pneumococcal diseases and rotavirus diarrhoeas are vaccine-preventable. We have to learn to use these vaccines in the national immunisation program." Farsighted policy on vaccines Lot many experts believe that there is a need for proper identification of vaccine requirements against specific diseases of priority. Doing own studies rather than only relying on foreign agencies also creates heartburns among those who oppose the mere populist measures. The policymakers have to keep open to ideas and that the polices must be updated on regular basis. There is an urgent need for active surveillance of the effects of the vaccine, which is currently lacking. The combination vaccines should not act as a back door entry for vaccines that we don't actually need. Now, the next big focus of the government is to introduce the IPV and pentavalent vaccines. Here the critical comments from an expert like Dr Jacob John sums up everything. He said, "When it came to polio, giving 3 doses for primary immunisation was the rule (was it policy?) but when science found that 3 was grossly inadequate and proposed 5 doses in first year, or pulse method to rapidly control polio, or to use IPV -- all in the early 1980, none of these was accepted -- here policy was in direct contradiction to science and until that gap was filled in the mid-2000s, we could not eliminate polio. Policy makers do not keep abreast of science." Prof NK Ganguly, former director general, Indian Council of Medical Research, said, "For a successful rollout of IPV in the country, the government needs to build capacity and ensure sufficient stocks and logistics. The availability of the vaccine would be a critical factor. We also need to build advocacy among the people and have trained manpower ready from the primary immunization field to administer the injections." Out of all the states and Union Territories, eight have already introduced pentavalent vaccines, 11 more will do by October this year and the remainder 17 will do so by April next year. The National Rural Health Mission has to play greater role in the states such as UP, Bihar, Madhya Pradesh, and Rajasthan that account for most of the deaths. ]]> <![CDATA[Pfizer reports $12.4 bn revenues in third-qtr 2014]]> https://biospectrumindia.com/news/95/5432/pfizer-reports-12-4-bn-revenues-in-third-qtr-2014.html https://biospectrumindia.com/news/95/5432/pfizer-reports-12-4-bn-revenues-in-third-qtr-2014.html Fri, 31 Oct 2014 10:45:00 +0530 Third-Quarter 2014 Reported Revenues of $12.4 Billion Third-Quarter 2014 Adjusted Diluted EPS of $0.57, Reported Diluted EPS of $0.42 Repurchased $4.2 Billion of Common Stock to Date in 2014 Updated Ranges for Certain 2014 Financial Guidance Components Mr Ian Read, chairman & CEO, Pfizer, stated, "Our key in-line products continued to perform well with our most recent product launches exhibiting further momentum during the quarter. We also generated solid revenue growth in emerging markets and see these geographies as continuing to offer attractive growth opportunities for the company. Regarding our development pipeline, we were pleased that the USFDA accepted our breast cancer compound, palbociclib, for review and also granted it Priority Review status....." At the beginning of fiscal year 2014, the company began managing its commercial operations through a new global commercial structure consisting of three operating segments: the Global Innovative Pharmaceutical segment (GIP); the Global Vaccines, Oncology and Consumer Healthcare segment (VOC); and the Global Established Pharmaceutical segment (GEP). "We remain strategically focused on driving increased innovation and enhancing our global competitive position both in terms of operational and financial efficiencies and remain opportunistic regarding business development that can enhance or accelerate our strategy. Given our continued strong financial position, I see Pfizer as well positioned to potentially allocate capital for the benefit of shareholders across multiple financial and strategic opportunities," Mr Read concluded. Mr Frank D'Amelio, CFO, Pfizer, stated, "Overall, I am pleased with our third-quarter 2014 financial results despite the continued negative impact from product losses of exclusivity and the termination of certain co-promotion collaborations. We updated certain components of our 2014 financial guidance to reflect our performance to date, recent changes in foreign exchange rates and our outlook for the remainder of the year, which continues to include the anticipated negative impact from multi-source generic competition for Celebrex in the US beginning in December 2014." "Additionally, the board of directors last week authorized a new $11 billion share repurchase program, to be utilized over time, in addition to the $1.3 billion of authorization remaining under the company's current share repurchase program. We continue to expect to repurchase approximately $5 billion of our shares this year, with $4.2 billion repurchased through October 27. We continue to expect these 2014 repurchases and planned repurchases to reduce total shares outstanding by approximately 100 million shares by the end of the year after factoring in actual and projected dilution related to employee compensation programs," Mr D'Amelio concluded. ]]> <![CDATA[Dr Reddy's global generics revenue touch Rs 28.9 bn]]> https://biospectrumindia.com/news/95/5750/dr-reddys-global-generics-revenue-touch-rs-28-9-bn.html https://biospectrumindia.com/news/95/5750/dr-reddys-global-generics-revenue-touch-rs-28-9-bn.html Fri, 31 Oct 2014 10:17:18 +0530 Key Highlights (Q2 FY15) o Consolidated revenues at â‚¹35.9 billion, year-on-year growth of 7 percent. â€¢ Revenues from the Global Generics (GG) segment at â‚¹28.9 billion, YoY growth of 9 percentâ€¢ Revenues from the Pharmaceutical Services and Active Ingredients (PSAI) segment at â‚¹6.4 billion. o Gross Profit Margin at 58.5 percent versus 58.0 percent as in Q2 FY 14. o Research and Development (R&D) expenses at â‚¹4.1 billion, 11.5 percent to revenues versus 9.0% to revenues as in Q2 FY14. o Selling, general and administrative (SG&A) expenses at â‚¹10.7 billion, 29.7 percent to revenues. o EBITDA of â‚¹8.7 billion, 24 percent of revenues. o Profit after tax at â‚¹5.7 billion, 16 percent of revenues. o During the quarter the company launched 9 new generic products, filed 10 new product registrations and 28 DMFs globally. On 18 October 2014, the company entered into an asset purchase agreement with Novartis Consumer Health Inc. to acquire the title and rights to Habitrol franchise (an over-the-counter nicotine replacement therapy transdermal patch) and to market the product in the US territory. The agreement is subject to FTC review and the transfer of asset will happen post FTC clearance. Segmental Analysis Global GenericsRevenues are at â‚¹28.9 billion, year-on-year growth of 9 percent, primarily driven by India, Rest of the World market territories (primarily Venezuela) and North America. o Revenues from North America at â‚¹14.3 billion, year-on-year growth of 8 percent. â€¢ Sustained performance of FY14 'limited competition' launches namely decitabine, azacitidine, and divalproex sodium ER.â€¢ Progress on market share expansion of key molecules namely divalproex sodium ER, metoprolol succinate and ziprasidone.â€¢ 1 new product launched during the quarter.â€¢ 2 ANDA filings during the quarter. Cumulatively, 72 ANDAs are pending for approval with the USFDA of which 45 are Para IVs, and we believe 11 to have 'First To File' status. o Revenues from Emerging Markets at â‚¹8.3 billion, year-on-year growth of 14 percent.â€¢ Revenues from Russia at â‚¹4.1 billion, year-on-year decline of 11 percent primarily on account of the Rouble devaluation. In constant currency the growth is flat.â€¢ Emerging Markets Ex-Russia at â‚¹4.2 billion recorded year-on-year growth of 57 percent primarily driven by strong performance in Venezuela Market. o Revenues from India for at â‚¹4.8 billion, year-on-year growth of 14 percent.â€¢ Growth is driven by healthy volume expansion in our focus brands, some of which are also listed under the NLEM portfolio. Pharmaceutical Services and Active Ingredients (PSAI)â€¢ Revenues from PSAI at â‚¹6.4 billion.â€¢ During the quarter 28 DMFs were filed globally, filed 3 in the US, 19 in the ROW and 6 in Europe. The cumulative number of DMF filings as of September 30, 2014 is 703. Income Statement Highlights:o Gross profit margin at 58.5 percent registered a 50 basis points improvement over Q2 FY14. Gross profit margin for GG and PSAI business segments are at 65.6 percent and 26.8 percent respectively. o SG&A expenses at â‚¹10.7 billion, year-on-year increase of 10 percent. The increase is largely due to annual increments, additional manpower deployment in the past 12 months and other sales and marketing spend for events specific to this quarter. o R&D expenses at â‚¹4.1 billion, year-on-year growth of 37 percent. 11.5 percent of revenues in Q2 FY15 as compared to 9.0 percent of revenues in Q2 FY14. The increase is in line with our planned scale-up in development activities. o Net Finance income at â‚¹421 million compared to â‚¹291 million in Q2 FY14. The increase is on account of:â€¢ Net reduction in forex benefit of â‚¹118 million â€¢ Net Incremental interest benefit of â‚¹247 million o EBITDA at â‚¹8.7 billion, year-on-year decline of 8 percent; 24 percent of revenues. o Profit after Tax at â‚¹5.7 billion, year-on-year decline of 17 percent; 16 percent of revenues. o Diluted earnings per share in Q2 FY 15 at â‚¹33.60 o Capital expenditure for Q2 FY15 is â‚¹2.3 billion. ]]> <![CDATA[AstraZeneca insources its IT ops]]> https://biospectrumindia.com/features/95/5516/astrazeneca-insources-its-it-ops.html https://biospectrumindia.com/features/95/5516/astrazeneca-insources-its-it-ops.html Fri, 31 Oct 2014 09:56:00 +0530 AstraZeneca which outsourced its IT requirement to IBM in 2001, is now ending its relationship with the IT major through the unveiling of its own new GTC, allowing insourcing of its IT operations. Faced with a series of R&D challenges and changes at the senior management level, AstraZeneca planned to invest in its new GTC at Chennai, which will significantly cut costs and will enable the company to fasten its grip on its work. Though Bangalore is known to be the Silicon Valley of India, AstraZeneca sees Chennai as the perfect location for its primary GTC. The company initially shortlisted a host of countries in Asia and Eastern Europe, but picked Chennai specifically to set its technology center in India. "Chennai fits well with our strategy. The city is India's healthcare capital and along with leading hospitals and medical colleges, the city has a strong focus on the biotechnology industry sector. Equally important, Chennai is an emerging IT hotspot and there's a large population of IT talent here as well as in neighboring regions," said AstraZeneca's spokesperson to BioSpectrum. "The arrival of the Chennai facility is just the start," it said. "We plan to establish global technology centres in San Francisco, USA in 2015, and extend our capability with two additional regional satellite centres in China and Eastern Europe." However, it does not intend to build additional GTCs in other locations in India. At 100,000 sq ft, the GTC in Chennai will be the largest of all the centres AstraZeneca has planned. This centre will drive the company's solutions, tools, technologies and capabilities enabling it to create innovative and pioneering drugs. The GTC is expected to support 50,000 of its staff in 100 countries. The centre currently employs 60 people, and it aims to expand the workforce to approximately 300 in the first year. "We aren't able to share figures for 2015-16 at this stage," said the spokesperson. AstraZeneca failed to comment on the investment that went into erecting the Chennai GTC. However, it is estimated that the new IT outsourcing centre is worth $9 million. According to the company, the Chennai's GTC will deliver application development, SAP, infrastructure management and operations, cloud, mobile, service operations and maintenance. "One of our key objectives is to achieve technical leadership in our IT, and our Chennai centre will give us the ability to build the world-class technical capability we need to achieve. We are looking to recruit individuals with global work experience, particularly consultants and engineers for large enterprise application platforms," commented AstraZeneca. AstraZeneca's GTC in San Francisco is expected to be operational in 2015, and will be a smaller technology centre with a few experts who will be able to use it as a base to tap into innovative tech thinking and technology in the area. ]]> <![CDATA[Indian agriculture experts discuss 'Open Access Policy']]> https://biospectrumindia.com/news/95/4642/indian-agriculture-experts-discuss-open-access-policy.html https://biospectrumindia.com/news/95/4642/indian-agriculture-experts-discuss-open-access-policy.html Fri, 31 Oct 2014 09:50:00 +0530 Working in this direction, a workshop on "Open Access to Agricultural Knowledge for inclusive Growth and Development" was inaugurated at National Academy of Agricultural Research Management (NAARM). The two-day (29-30 October, 2014) deliberations are expected to develop the strategies for not only access to data but also the improved content and turning them into solutions utilizing appropriate applications. The workshop was jointly organized by NAARM and the Global Forum on Agricultural Research (GFAR) and FAO Rome, as a part of 'Open Access Week'. The Workshop aims to review the current status of open knowledge resources in agriculture in India, identify the gaps and needs to improve open knowledge access, and use and scope for further collaborations with national and global agencies. Dr Ajit Maru, senior knowledge Officer, FAO, Rome, delivered opening keynote address stressing on aspects like India's potential for agricultural development and challenges; choices for agricultural information and knowledge services and sharing. He touched upon global movement in open agricultural data and information and knowledge, and benefits that India can reap in this field. Speaking as guest of honor, Dr KR Murali Mohan, adviser, Department of Science and Technology (DST), New Delhi elaborated on 'Big Data Initiative' taken up by DST highlighting economic benefits and employment potential of this initiative across the sectors in India. The agricultural technocrats can make the difference in the country by adopting and practicing the open knowledge through technology platform created by National Informatics Centre (NIC) i.e., data.gov.in, he said. Prof. M Moni, former DG, NIC, New Delhi, stressed on inclusive growth with the power of open data knowledge management. Library science professionals should be in the forefront on achieving accessibility and sharing of data, he added. He also suggested establishing 'India ring' similar to 'China ring' with the help of ICTs. Earlier, Dr D Rama Rao, director, NAARM welcomed the gathering. He elaborated on Open Access initiatives in ICAR and explained key features of the OA policy. Around 80 farmer representatives, scientists, faculty, and officers from ICAR, CSIR, NGOs, DST, CBOs, private sector and State Agricultural Universities are participating in the workshop. ]]> <![CDATA[Serum Institute to expand India operations]]> https://biospectrumindia.com/news/95/5339/serum-institute-to-expand-india-operations.html https://biospectrumindia.com/news/95/5339/serum-institute-to-expand-india-operations.html Thu, 30 Oct 2014 13:24:30 +0530 Indian vaccines major, Serum Institute is expanding its network in India by setting up a new manufacturing plant in Pune. According to sources, the company is planning to invest $163mn to set up the new vaccine facility. Serum Institute is the world's fifth largest vaccine manufacturer, with an installed capacity of over one billion doses of vaccines annually. The company currently has two manufacturing sites in Pune and Netherlands. Mr Adar C Poonawalla, CEO, Serum Institute, said, "The company will be manufacturing vaccines for pneumonia, rotavirus, dengue and many other diseases in the plant." Mr Poonawalla mentioned that in addition to the new plant the company is also considering expansion of its Netherlands facility. "The investment for the acquisition and expansion of the Bilthoven Biologicals cumulatively over last two years will be around $255 million," he said. Mr Poonawalla further stated that the company is focusing on small and strategic acquisitions that support its vaccine base, for expansion. The acquisition of Bilthoven Biologics provided Serum with the technology to manufacture injectable polio vaccine. The company is the largest suppliers of vaccines to over 140 countries, worldwide. ]]> <![CDATA[UAS Labs to expand India business]]> https://biospectrumindia.com/news/95/3853/uas-labs-to-expand-india-business.html https://biospectrumindia.com/news/95/3853/uas-labs-to-expand-india-business.html Thu, 30 Oct 2014 11:09:27 +0530 UAS Labs, a major player in probiotics has announced plans to further invest in the growing Indian probiotics market. The company has been active in India for several years with a solid business base and loyal customers. There has been a significant increase in interest amongst top pharmaceutical and nutraceutical companies in UAS Labs' industry-leading probiotic products and services. To meet this increased demand, the comapny has decided to unveil its new facility. "We are delighted to have officially established UAS Life Sciences in India. It will operate not only as a hub for our growing India-based business interests, but will also allow us to better serve our expanding Asian customer base. UAS looks forward to bringing more of our scientifically based probiotic formulations to this dynamic market," said UAS Labs' president and CEO Mr Kevin Mehring. The company has hired Mr Subramanya Shastry Kavuri to develop its operations in India. He brings 29 years of international experience in sales and technical marketing to UAS Labs including several years focused on probiotics. ]]> <![CDATA[India gets its own diagnostic kit for Celiac diseases]]> https://biospectrumindia.com/news/95/5386/india-gets-its-own-diagnostic-kit-for-celiac-diseases.html https://biospectrumindia.com/news/95/5386/india-gets-its-own-diagnostic-kit-for-celiac-diseases.html Thu, 30 Oct 2014 10:45:00 +0530 The cost-effective diagnostic test kit is the first of its kind in India for the autoimmune "Celiac disease", which is a lifelong intestinal disorder manifesting as intolerance to certain foods such as wheat, barley, etc., with symptoms like recurring abdominal pain, diarrhoea, and weight loss. The diagnostic kit has been developed by the Department of Biotechnology (DBT) through a project sponsored by it with the involvement of All India Institute of Medical Sciences (AIIMS), International Center for Genetic Engineering and Biotechnology (ICGEB) and an industrial partner, J Mitra and Co. The diagnostic assay test, through this method, will be affordable, rapid, sensitive, and more specific, allowing prompt therapeutic interventions.The assays comprise of two tests: Celiac Microlisa, which is based on indirect Elisa; and Celiac Card which is a point-of-care test giving result in 20 minutes time. These tests are thus very useful in the screening of patients suspected to have this disease and can be done in any part of the country. Furthermore, this test does not require a sophisticated laboratory and highly skilled personnel. The kit was formally launched for commercial use by the science and technology minister, Dr Jitendra Singh at New Delhi on October 28, 2014. Present on the occasion were Dr Mauro Giacca, director general, ICGEB Treste, Italy, Dr Vijay Raghavan, secretary, DBT and senior faculty of AIIMS, New Delhi. This launch comes close on the heels of the Department of Science and Technology (DST) launching a cost-effective injectable Polio vaccine, and ROTA virus vaccine about two months ago. Terming the Indian profile of most of the diseases different from the rest of the world, Dr Jitendra Singh said that it requires exclusive management, partly because of the different Indian phenotype or genetic makeup and partly because of the tropical dimensions of the disease. This, he said, applies to a variety of diseases including autoimmune disorders like Celiac disease, Type 1 Diabetes Mellitus, Osteoporosis, and host of other associated disorders. Globally, there has been an increase in the number of patients diagnosed with celiac disease. In celiac disease, the inner lining of the small intestine (where food is digested and absorbed) gets damaged and food is not absorbed properly. Non-absorption of food leads to weight loss, failure to gain weight, prolonged diarrhea, abdominal fullness, bulky stools, and anemia (lack of blood). ]]> <![CDATA[Dr Reddy's launches Rapamune's generic version in the US]]> https://biospectrumindia.com/news/95/3972/dr-reddys-launches-rapamunes-generic-version-in-the-us.html https://biospectrumindia.com/news/95/3972/dr-reddys-launches-rapamunes-generic-version-in-the-us.html Thu, 30 Oct 2014 10:00:00 +0530 The generic drug has received approval nod from the United States Food and Drug Administration (USFDA). The Rapamune tablets brand had US sales of approximately $206 million MAT for the most recent twelve months ending in August 2014, according to IMS Health. Dr Reddy's Sirolimus tablets are available in 1mg and 2mg in bottle counts of 100. ]]> <![CDATA[Lupin posts Q2 results]]> https://biospectrumindia.com/news/95/5349/lupin-posts-q2-results.html https://biospectrumindia.com/news/95/5349/lupin-posts-q2-results.html Thu, 30 Oct 2014 09:45:00 +0530 Lupin Ltd has announced the following results on Bombay Stock Exchange for the quarter ended September 30, 2014: The Unaudited Standalone results for the Quarter ended September 30, 2014 The Company has posted a net profit of Rs. 4596.20 million for the quarter ended September 30, 2014 as compared to Rs. 8091.20 million for the quarter ended September 30, 2013. Total Income has decreased from Rs. 25414.80 million for the quarter ended September 30, 2013 to Rs. 23478.30 million for the quarter ended September 30, 2014. The Consolidated Results are as follows: The Unaudited Consolidated results for the Quarter ended September 30, 2014 The Group has posted a profit after taxes and minority interest of Rs. 6300.40 million for the quarter ended September 30, 2014 as compared to Rs. 4061.80 million for the quarter ended September 30, 2013. Total Income has increased from Rs. 27492.30 million for the quarter ended September 30, 2013 to Rs. 32836.40 million for the quarter ended September 30, 2014. ]]> <![CDATA[PM clears Dr Sahoo's appointment as director of IBSD]]> https://biospectrumindia.com/news/95/5960/pm-clears-dr-sahoos-appointment-as-director-of-ibsd.html https://biospectrumindia.com/news/95/5960/pm-clears-dr-sahoos-appointment-as-director-of-ibsd.html Wed, 29 Oct 2014 14:53:00 +0530 Dinabandhu Sahoo, a professor of Botany in Delhi University, is set to take over as Director of the Imphal-based Institute of Bio-resources and Sustainable Development. The insitute, under department of Science and Technology, didn't had any full time director since 2009. Dr Dinabandhu Sahoo has been a scientist of international repute with vast experience in the field of environmental biotechnology and sustainable development. Dr Sahoo who recently took over as the director of the institute intends to provide a new direction to its fuctioning. Sharing his thoughts with the BioSpectrum, he mentioned, "I am much excited to carry forward the vision of development of North-Eastern region and look forward to work in this direction." It is important to mention here that Dr Sahoo was the first Indian student to visit Antarctica during 1987-88 in the 7th Indian Scientific Expedition. He undertook two trips to Arctic during 1991 and 1992. He has visited all the seven continents and five oceans within a record time of 18 months during 1988-89. He had his training in algal cultivation and utilization at more than two dozen countries. He participated in many national and international conferences. Dr Sahoo is also the honorary director of JD Centre of Art, Culture and Environment India. He received the highest award from National Environmental Science Academy, India in 2009 for his outstanding contribution in the field of Marine Science. Dr Sahoo received one of the most prestigious award from Odisha, Botanical Society for Popularization of Plant Science 2009. Dr Sahoo co-directed a documentary film "Chilika:The Untold Story". ]]> <![CDATA[Biomaterials for future: Scientists converge at IIT Delhi ]]> https://biospectrumindia.com/news/95/5147/biomaterials-for-future-scientists-converge-at-iit-delhi-.html https://biospectrumindia.com/news/95/5147/biomaterials-for-future-scientists-converge-at-iit-delhi-.html Wed, 29 Oct 2014 12:50:18 +0530 This is an upcoming area in the field of science and technology and added that just as in the middle and last half of 20th century the emphasis was on physics and electronics, in the first quarter of the 21st century, the focus is going to be on research in the areas of biomaterials, bioengineering and biodiagnostics, stated the union minister of state for science and technology, Dr Jitendra Singh while inaugurating the conference on biomaterials at New Delhi. The event has been organized by the Indian Institute of Technology (IIT), Delhi in collaboration with the Italian National Agency for New Technologies. In addition to the symposia, the 4-day conference also included "microsymposia" on certain lesser discussed topics such as aloe vera, biosensors, and bioplastics. Dr Jitendra Singh further mentioned that it is a strange yet healthy paradox that each stream of science is growing into a highly exclusive super specialty of its own but at the same time, science scholars are also realizing the importance and viability of coordination among these apparently different streams. This remarkably manifests, for example, in the form of bioengineering which is a synergy of two different streams of science and yet a specialty on its own, he observed. Dr Singh said that it is a sign of elevation to higher level of academics that the IITs have been constantly experimenting with new areas of scientific technology and have truly proved to be the most cherished seats of learning in contemporary India. Present on the occasion among others were Prof. R K Shevgaonkar, director, IIT Delhi, Dr Bhuvanesh Gupta, professor, IIT Delhi. Dr Lindia, scientific counsellor Italian Embassy, also spoke on the occasion. ]]> <![CDATA[Vaccines: new initiatives for developing countries ]]> https://biospectrumindia.com/news/95/5000/vaccines-new-initiatives-for-developing-countries-.html https://biospectrumindia.com/news/95/5000/vaccines-new-initiatives-for-developing-countries-.html Wed, 29 Oct 2014 12:23:43 +0530 In its 15th annual general meeting, the Developing Countries Vaccine Manufacturers Network (DCVMN) International on October 28, 2014, launched multiple initiatives to accelerate access to affordable high-quality vaccines. The DCVMN International announced their intention to support access to affordable high-quality vaccines by enabling a larger number of vaccine manufacturers to achieve a more sustainable and secure supply of priority vaccines for international procurement, particularly for GAVI-eligible countries, with the common goal of protecting people against known and emerging infectious diseases globally. DCVMN through its members and additional global health stakeholders have been working together since early this year, in identifying needs and challenges of the vaccine industry in developing countries. The four areas of action that have been agreed to strengthen and foster sustainable vaccine supply include the review of manufacturing facilities design; provide adequate training on evolving GMP requirements, quality management systems, and the WHO standards and prequalification; encourage dialogue on regulatory challenges; and facilitate access to independent experts able to resolve vaccine industry specific issues. The three years' project costs of over 3.6 million dollars, pf which 60 percent will be sourced by international global health organizations and the remaining jointly by DCVMN members and partners. The priority vaccines to be targeted encompass pentavalent, hexavalent, pneumococcal conjugate, rotavirus, typhoid conjugate, human papillomavirus, measles/rubella, and inactivated polio vaccines. "With two out of three children in the world receiving lifesaving vaccines from emerging manufacturers, and as the world's population is growing at the fastest rate in developing countries, it is important to ensure improved manufacturing in every facility we can reach" said Mr Mahendra Suhardono, president of DCVMN. All members involved in funding these initiatives reiterated the vision of developing countries free of suffering and disabilities from major infectious diseases. They also pledged to work together to foster the development and supply of safe, effective and affordable vaccines for the future generations of world's developing nations. ]]> <![CDATA[Dupont's hybrid seeds to reduce water usage]]> https://biospectrumindia.com/news/95/5138/duponts-hybrid-seeds-to-reduce-water-usage.html https://biospectrumindia.com/news/95/5138/duponts-hybrid-seeds-to-reduce-water-usage.html Wed, 29 Oct 2014 12:19:14 +0530 "There is an urgent need to reduce water use in agriculture by developing new technologies that will help secure and enhance yields for farmers. The combination of changes in grower practices, increased availability of drought tolerant seeds, crop protection and crop diversification as well as improved farmer education will increase not only yields but also reduce pressure on natural resources," said Mr Sharad Khurana, business leader, DuPont Pioneer. DuPont has introduced solutions towards agricultural production that overcome the issue of water shortage, through innovations such as high yielding seeds and crop agronomical practices like crop diversification. Agriculture is India's largest consumer of water. According to The World Bank, an estimated 114 million Indians will soon face domestic, agricultural, and industrial water shortages. In fact, China and India, with one-third of the world's people, have between them less than 10 percent of the world's fresh water. Water scarcity has a critical impact on agricultural productivity and hence, food security. Recognizing these challenges, as per DuPont, it is addressing them through a variety of new technologies and innovative agricultural practices. In Andhra Pradesh, DuPont Pioneer seeds has introduced a new type of hybrid corn that requires less water and can thrive within the state's changing climactic conditions. DuPont has also worked with the Punjab government to introduce crop diversification for growing varieties like corn and rice to reduce water usage considerably. In both the states, DuPont said that it took a well-rounded approach of creating awareness, holding crop seminars, distributing seeds, and providing right agronomic services in these states. These efforts have helped farmers to maximize their yields and have sustained income through the year, without draining valuable water resources. DuPont Pioneer is among the world's leading developer and supplier of advanced plant genetics, providing high-quality seeds to farmers in more than 90 countries. Pioneer provides agronomic support and services to help increase farmer productivity and profitability, and strives to develop sustainable agricultural systems for people everywhere. ]]> <![CDATA[Ranbaxy reveals Q2 2014 results]]> https://biospectrumindia.com/news/95/5060/ranbaxy-reveals-q2-2014-results.html https://biospectrumindia.com/news/95/5060/ranbaxy-reveals-q2-2014-results.html Wed, 29 Oct 2014 10:03:00 +0530 Ranbaxy Laboratories announced the following results for the quarter ended September 30, 2014: The Unaudited Standalone results for the Quarter ended September 30, 2014 The Company has posted a net loss of Rs 3682.57 million for the quarter ended September 30, 2014, as compared to net loss of Rs 8422.32 million for the quarter ended September 30, 2013. The total income has decreased from Rs 14701.86 million for the quarter ended September 30, 2013 to Rs 13389.31 million for the quarter ended September 30, 2014. The Consolidated Results are as follows: The Unaudited Consolidated results for the Quarter ended September 30, 2014 The Group has posted a net profit after tax, minority interest and share in profit of associates of Rs 4777.56 million for the quarter ended September 30, 2014 as compared to net loss of Rs 4541.69 million for the quarter ended September 30, 2013. Total income has increased from Rs 28277.34 million for the quarter ended September 30, 2013 to Rs 32778.76 million for the quarter ended September 30, 2014. ]]> <![CDATA[Novozymes tastes robust sales in Q3 2014]]> https://biospectrumindia.com/news/95/5657/novozymes-tastes-robust-sales-in-q3-2014.html https://biospectrumindia.com/news/95/5657/novozymes-tastes-robust-sales-in-q3-2014.html Wed, 29 Oct 2014 09:51:00 +0530 "Like nature, our business is truly diverse," said Mr Peder Holk Nielsen, Novozymes' CEO. "Through combining industrial insight with our unique biotechnology platform, we have been able to create diverse solutions that are relevant for a wide range of customers in many different markets throughout the world today. That is why our sales remain strong in spite of signs of uncertainty in the global economy and in some of our markets." In 2013, Novozymes was estimated to have a 48 percent share of the global enzyme market, selling more than 700 products all over the world for applications as diverse as detergents, biofuels, agriculture, food and beverages, biopharmaceuticals, wastewater, textiles and pulp and paper. ]]> <![CDATA[Merck's worldwide sales decrease by 4%]]> https://biospectrumindia.com/news/95/5597/mercks-worldwide-sales-decrease-by-4.html https://biospectrumindia.com/news/95/5597/mercks-worldwide-sales-decrease-by-4.html Tue, 28 Oct 2014 14:44:06 +0530 "Last October, we launched a multi-year initiative to transform Merck and build a platform for sustained, future growth," said Mr Kenneth C Frazier, chairman and CEO, Merck. "One year later, we delivered solid third-quarter results and are making steady progress in our transformation, including divesting non-core assets, reducing our expense base and investing in our promising new product launches and pipeline." Pharmaceutical Revenue Performance The company's third-quarter pharmaceutical sales declined 4 percent to $9.1 billion. Expected declines occurred due to the ongoing impact of product divestitures, as well as the loss of market exclusivity for certain products, including TEMODAR (temozolomide) and SINGULAIR (montelukast sodium). Also contributing to the decline were lower sales from the hepatitis franchise of VICTRELIS (boceprevir) and PEGINTRON (peginterferon alfa-2b) as a result of increased competition, as well as of GARDASIL [Human Papillomavirus Quadrivalent (Types 6, 11, 16, and 18) Vaccine, Recombinant]. These declines were partially offset by growth in the global acute care franchise, including NOXAFIL (posaconazole) and BRIDION (sugammadex); the diabetes franchise of JANUVIA (sitagliptin)/JANUMET (sitagliptin and metformin HCI); REMICADE (infliximab); SIMPONI (golimumab); and DULERA (mometasone furoate and formoterol fumarate dihydrate). Combined sales of JANUVIA and JANUMET, medicines that help lower blood sugar levels in adults with type 2 diabetes, grew 5 percent to $1.4 billion in the third quarter. The growth reflects higher sales in the United States and Europe, which were partially offset by price reductions in Japan. Combined sales of ZETIA (ezetimibe) and VYTORIN (ezetimibe/simvastatin), medicines for lowering LDL cholesterol, declined 3 percent to $1.0 billion in the third quarter, driven by lower sales in the United States. Combined sales of REMICADE and SIMPONI, treatments for inflammatory diseases, grew 11 percent to $774 million in the third quarter, including a 2 percent positive impact from foreign exchange. Over the last 12 months, SIMPONI has been the fastest growing anti-TNF agent in all countries where marketed by Merck. Merck's sales of GARDASIL, a vaccine to help prevent certain diseases caused by four types of human papillomavirus, were $590 million, a decrease of 11 percent for the third quarter. The results reflect lower purchases in the US public sector. Worldwide sales of ISENTRESS, an HIV integrase inhibitor for use in combination with other antiretroviral agents for the treatment of HIV-1 infection, decreased 3 percent to $412 million in the third quarter. The decline reflects lower sales in the United States, partially offset by growth in Europe. On September 4, 2014, the US Food and Drug Administration (FDA) granted accelerated approval of KEYTRUDA (pembrolizumab), the first approved anti-PD-1 therapy in the United States. KEYTRUDA has been approved for the treatment of patients with unresectable or metastatic melanoma and disease progression following ipilimumab and, if BRAF V600 mutation positive, a BRAF inhibitor. Within a few days of approval, initial orders shipped, and the Merck team has already reached more than 75 percent of key physicians. Merck believes there are currently approximately 1,200 patients who may be eligible for KEYTRUDA, based on the product's label, and to date, approximately 900 patients are being treated with KEYTRUDA. ]]> <![CDATA[Eli Lilly's worldwide revenue dips by 16%]]> https://biospectrumindia.com/news/95/5630/eli-lillys-worldwide-revenue-dips-by-16.html https://biospectrumindia.com/news/95/5630/eli-lillys-worldwide-revenue-dips-by-16.html Tue, 28 Oct 2014 14:19:05 +0530 According to the company's statement, the revenue decline was comprised of 16 percent due to lower volume; the impact of changes in price and foreign exchange rates on worldwide revenue was negligible. The 16 percent decrease in worldwide volume was primarily driven by the loss of US patent exclusivity for Cymbalta, and to a lesser extent Evista, partially offset by volume gains for most other products. Total revenue in the US decreased 33 percent to $2.218 billion, driven primarily by lower demand for Cymbalta and Evista following their patent expirations. Total revenue outside the US increased 8 percent to $2.658 billion, driven by higher volume. Gross margin decreased 21 percent to $3.609 billion in the third quarter of 2014 compared to the third quarter of 2013, driven by lower sales of Cymbalta and Evista due to the loss of the US patent exclusivity. Gross margin as a per cent of total revenue was 74 percent, a decrease of 5.2 percentage points compared with the third quarter of 2013. The decrease in gross margin percent was primarily due to lower sales of Cymbalta and Evista following US patent expirations. Total operating expenses in the third quarter of 2014, defined as the sum of research and development and marketing, selling and administrative expenses, were $2.915 billion, a decrease of 4 percent compared with the third quarter of 2013. R&D expenses decreased 10 percent to $1.243 billion, or 25.5 percent of total revenue, driven primarily by lower late-stage clinical development costs in the third quarter of 2014, partially offset by a $63 million charge associated with the termination of tabalumab development. Marketing, selling and administrative expenses increased 1 percent to $1.672 billion, due primarily to a $119 million charge associated with the Branded Prescription Drug Fee, partially offset by a reduction in sales and marketing activities for Cymbalta, as well as ongoing cost containment efforts. In the third quarter of 2014, the company recognized acquired in-process research and development charges totaling $95 million related to collaboration agreements with Immunocore Limited and AstraZeneca. In the same quarter, the company recognized asset impairment, restructuring and other special charges of $36.3 million, primarily severance, associated with ongoing cost containment efforts and costs related to the pending acquisition of Novartis Animal Health. There were no such charges in the third quarter of 2013. Operating income in the third quarter of 2014 was $562.0 million, a decrease of 64 per cent compared to the third quarter of 2013, driven by lower gross margin, partially offset by lower operating expenses. Other income (expense) was income of $93.5 million in the third quarter of 2014, compared with expense of $31.3 million in the third quarter of 2013, driven primarily by gains on the sale of investment securities and income from milestones earned. The effective tax rate was 23.6 percent in the third quarter of 2014, compared with 20.5 percent in the third quarter of 2013. The effective tax rate for the third quarter of 2014 includes the negative impact of the expiration of the R&D tax credit in the US at the end of 2013. In the third quarter of 2014, net income and earnings per share decreased 58 percent to $500.6 million and $0.47, respectively, compared with third quarter 2013 net income of $1.203 billion and earnings per share of $1.11. The decreases in net income and earnings per share were driven by lower operating income. Third-Quarter 2014 Non-GAAP Measures On a non-GAAP basis, operating income decreased $732.3 million, or 47 percent, to $812.4 million, driven by lower gross margin, partially offset by lower operating expenses. The effective tax rate increased to 22.0 percent, compared with 20.5 percent in the third quarter of 2013. The effective tax rate for the third quarter of 2014 includes the negative impact of the expiration of the R&D tax credit in the US at the end of 2013. Net income and earnings per share decreased 41 percent to $706.6 million and $0.66, respectively, compared with $1.203 billion and $1.11 during the third quarter of 2013. Non-GAAP measures exclude items totaling $0.19 per share of expense in the third quarter of 2014. ]]> <![CDATA[BMS' int'l revenues dip by 4%]]> https://biospectrumindia.com/news/95/4973/bms-intl-revenues-dip-by-4.html https://biospectrumindia.com/news/95/4973/bms-intl-revenues-dip-by-4.html Tue, 28 Oct 2014 10:12:00 +0530 The quarter was highlighted by strong performance by key brands, significant data and regulatory milestones for Opdivo, the launch of the company's hepatitis-C regimens in Japan and Europe and the completion of several business development transactions supporting the company's oncology portfolio. "Our financial results in the third quarter reflect our continued focus on balancing long-term growth with short-term performance, as we achieved significant progress in our pipeline and saw strong in-market performance for key products including Eliquis, Yervoy, Sprycel and Orencia," said Mr Lamberto Andreotti, CEO, Bristol-Myers Squibb. "We continue to build a solid foundation for our future as a Diversified Specialty BioPharma by advancing our own R&D efforts and investing in strategic business development to build a sustainable pipeline." THIRD QUARTER FINANCIAL RESULTS â€¢ Bristol-Myers Squibb posted third quarter 2014 revenues of $3.9 billion, a decrease of 4 percent compared to the same period a year ago. Excluding the divested Diabetes Alliance, global revenues increased 7 percent. â€¢ US revenues decreased 3 percent to $2.0 billion in the quarter compared to the same period a year ago. International revenues decreased 4 percent. â€¢ Gross margin as a percentage of revenues was 74.3 percent in the quarter compared to 71.1 percent in the same period a year ago. â€¢ Marketing, selling, and administrative expenses increased 5 percent to $1.0 billion in the quarter. â€¢ Advertising and product promotion spending decreased 12 percent to $171 million in the quarter. â€¢ Research and development expenses increased 10 percent to $983 million in the quarter. â€¢ The effective tax rate on earnings before income taxes was 27.4 percent in the quarter, compared to 15.4 percent in the third quarter last year. â€¢ The company reported net earnings attributable to Bristol-Myers Squibb of $721 million, or $0.43 per share, in the quarter compared to $692 million, or $0.42 per share, a year ago. â€¢ The company reported non-GAAP net earnings attributable to Bristol-Myers Squibb of $750 million, or $0.45 per share, in the third quarter, compared to $768 million, or $0.46 per share, for the same period in 2013. Among other specified items, the non-GAAP earnings in the current period exclude a $0.07 per share impact of additional charges related to the Branded Prescription Drug Fee resulting from the issuance of final rules by the IRS. An overview of specified items is discussed under the 'Use of Non-GAAP Financial Information' section. â€¢ Cash, cash equivalents and marketable securities were $11.5 billion, with a net cash position of $3.9 billion, as of September 30, 2014. ]]> <![CDATA[Workshops on cancer biology being held across India]]> https://biospectrumindia.com/news/95/5417/workshops-on-cancer-biology-being-held-across-india.html https://biospectrumindia.com/news/95/5417/workshops-on-cancer-biology-being-held-across-india.html Tue, 28 Oct 2014 10:03:00 +0530 These workshops will include a select international delegation of cancer researchers along with scientists from India who will try to identify questions that highlight important areas of cancer research that are understudied or forgotten. These will be held on October 27-29, 2014 in Delhi; October 30-November 1, 2014 in Bangalore; and November 3-5, 2014 in Trivandrum. DBT has been funding Cancer Research along with other funding departments for over two decades now. Several specific calls for proposals have been issued, however there are many grey areas including in India specific cancers that need special attention by the research community to provide better diagnosis, preventive strategies, therapeutics and palliative care. The best of these questions will be presented to the research community as part of a Request for Applications (RFA) in which scientists can apply for funding to answer some facet of the provocative question. The Indian workshops' activities will seek to develop a set of questions from which the best will be offered for one or more RFAs sponsored by various groups within the Indian government and the NCI. The Indian workshops' activities will seek to develop a set of questions from which one or more RFAs jointly sponsored by NCI and DBT may emerge. The collaborative process of formulating the provocative questions in cancer has been experimented upon by the NCI- NIH; it resulted into identifying many crucial questions that resulted into invited research proposals. It is now aimed to engage the NCI's scientific community in serious debate with Indian cancer researchers and energize them & other constituencies (advocacy groups, health professionals, Members of Congress, and others) about the prospects for improving the welfare of cancer patients through research. Other constituencies are encouraged to take part in the "Provocative Questions" enterprise through discussions and activities. The format of PQW would include a select international delegation of cancer researchers along with scientists from India suggesting and discussing Provocative Questions in style to the ongoing research planning effort being led by the NCI. For the last three years NCI has led an effort to identify questions that highlight important areas of cancer research that are understudied or forgotten. The recent technological advances worldwide, in various area of cancer especially genomics, molecular biology, and computational sciences has opened fresh avenues for research. Humungous transformation has been achieved in the basic knowledge about the genetic and biochemical aspects of cancer research by which they arise. Now there is an opportunity for us to take a step back from the momentum of these discoveries and make sure we have left no stone unturned and no important but perhaps non-obvious question left unexplored. ]]> <![CDATA[Geo-political challenges mute Biocon's fiscal growth]]> https://biospectrumindia.com/news/95/4962/geo-political-challenges-mute-biocons-fiscal-growth.html https://biospectrumindia.com/news/95/4962/geo-political-challenges-mute-biocons-fiscal-growth.html Tue, 28 Oct 2014 09:57:00 +0530 The company's biopharma segment recorded revenues of Rs 442 crore in Q2 FY15. "The biopharma business continues to be impacted by various factors like geo-political challenges in terms of credit risk in the MENA region, reduced off-take of specialty API, and capacity constraints, affecting the growth of this business. The outlook for the biopharma business remains challenging for the remaining part of this fiscal," the company said in a statement. Commenting on the quarterly performance and highlights, Dr Kiran Mazumdar-Shaw, CMD, Biocon, stated, "The growth of our core biopharma business this quarter has been muted largely due to capacity constraints and geo-political challenges in the Middle-East. However, clinical progress in our key global programs for generic Insulin Glargine and Trastuzumab is indicative of the value accretion that is realizable in the foreseeable future. The strategic investment by Silver Leaf Oak in Syngene validates the strength of our research services business and sets a good valuation benchmark. Whilst we continue to invest in R&D and capacity building for our insulins and antibodies portfolio, we expect Branded formulations and research services businesses to drive growth in the interim." According to Biocon, the Malaysia insulin facility remains on track to be commissioned in H2 FY15. "The commercialization of products from Malaysia will commence post validation and regulatory approvals from respective countries," it held. It also revealed that its partner Mylan has initiated multicenter phase III trials for insulin glargine in the United States. "Two trials, both for 24 weeks, comprising a total of 1100 patients (500 type-1 diabetes mellitus patients and 600 type-2 diabetes mellitus patients) are expected to be completed by June 2016," said Biocon. The Branded formulations business of Biocon recorded revenues of Rs 116 crore and its research services segment recorded revenues of Rs 192 crore respectively. Commenting on this performance, Mr Peter Bains, director, Syngene International, said, "Research services delivered a sequential revenue growth of 11 per cent in Q2 FY15 reflecting steady business traction for our services. Our recent capacity additions have come online and we have a strong order book to support these in the near term. We continue to invest further across new and existing service platforms to sustain our growth curve and support the developing pipelines of our clients. A key highlight this quarter was the successful completion of a USFDA pre-approval inspection of one of our manufacturing facilities. We have, in the past 12 months, cleared two successive FDA audits with no 483s, underpinning the quality of our systems and processes." This quarter, Biocon, through its wholly owned subsidiary Biocon Research Limited (BRL), purchased the 7.69 percent stake held by GE Equity International Mauritius in Syngene International Limited (Syngene) for an agreed consideration of Rs 215.38 crore. Subsequently, Silver Leaf Oak (Mauritius) Limited, an investment vehicle advised by India Value Fund Advisors (IVFA) agreed to acquire a minority 10 percent stake in Syngene from BRL at a valuation of Rs 3,800 crore. ]]> <![CDATA[Baxter's Hemophilia drug gets US FDA nod]]> https://biospectrumindia.com/news/95/4925/baxters-hemophilia-drug-gets-us-fda-nod.html https://biospectrumindia.com/news/95/4925/baxters-hemophilia-drug-gets-us-fda-nod.html Mon, 27 Oct 2014 14:16:21 +0530 Baxter International has announced that the United States Food and Drug Administration (US FDA) has approved OBIZUR [Antihemophilic Factor (Recombinant), Porcine Sequence] for the treatment of bleeding episodes in adults with acquired hemophilia A (AHA), a very rare and potentially life-threatening acute bleeding disorder. The drug was granted orphan-drug status by the FDA and its review was prioritized based on AHA's classification as a rare disease and the potential for the treatment to address an important unmet medical need. ''As a new treatment option with the ability to measure FVIII activity in the body, OBIZUR will address important unmet needs for patients with acquired hemophilia A, a potentially life-threatening condition,'' said Mr Brian Goff, head of Baxter's hemophilia franchise. He added, ''This approval reflects Baxter's long-standing commitment to discovering new options for hemophilia patients and adds to our portfolio of treatments that reduce the burden of these diseases.'' It is also currently under regulatory review in Europe and Canada. ]]> <![CDATA[India readies its Ebola action plan ]]> https://biospectrumindia.com/news/95/5441/india-readies-its-ebola-action-plan-.html https://biospectrumindia.com/news/95/5441/india-readies-its-ebola-action-plan-.html Mon, 27 Oct 2014 13:30:19 +0530 The union health minister, Dr Harsh Vardhan pointed out that India already has a highly rated integrated disease surveillance network. "We have removed all stops to constantly upgrade equipment and retrain staff and are in the process of further strengthening them," he said. Dr Vardhan who held a meeting of officials from the health ministry, along with representatives of the ministries of defence, civil aviation, home, shipping, external affairs, some state governments, the Indian army, navy, and national disaster management authority, said all international airports and sea ports will soon be fitted with thermal scanners and other EVD detection equipment for 24x7 deployment. Officials of the WHO and the United States Center for Disease Control and Prevention were also present. The use of thermal scanners, which has made Nigeria's success possible, is widely prevalent in most of the 15 major airports, often two to each. A further lot of scanners will be purchased and installed over the next few days at the minister's orders. Dr Harsh Vardhan said, "These scanners, which resemble the radar guns used by police officers to catch speeding motorists, can detect high body temperature among people queued up before immigration counters. Fever is one of the most common symptoms of EVD. Our officials have already used thermal scanners when SARS broke out in Southeast Asia some years back." He pointed out that a guidance paper produced by the United States Center for Disease Control and Prevention, Atlanta, has outlined all the facets of operating this hardware. "There is a need for constant maintenance, frequent calibration and carrying out of training of people using them," the minister said. Health authorities of New Delhi's Indira Gandhi International Airport conducted a mock drill recently to test out the alertness of the Ebola detection center there. The minister has instructed similar tests be carried out at all airports in the country within a few days and at regular intervals. The minister took detailed reports from representatives of all the ministries and discussed ways to strengthen the system. As of now, there has not been a single case of an EVD patient arriving in India. A few people with high body temperature were quarantined and their blood samples sent to two designated laboratories in the country. Another 10 laboratories are being kept on standby in case of necessity. On being tested negative for EVD they were allowed to continue with their journey in the country albeit after leaving their future addresses with the authorities. They are tracked for the remainder of the incubation period of the virus (21 days). Dr Vardhan said India had prepared early. "We held our first meeting on Ebola in early June, whereas WHO declared an international emergency in the last week of August. Our officials got to work by updating their skills in managing detecting systems, disseminating information, and preparing for all kinds of situations." "We used a war-room approach to coordinate the outbreak response. Our strict procedures for screening all arrivals and communicating with the Indians living in the African continent are in tune with international standards," he explained. The minister has however warned against complacency. "If a single case of Ebola is detected, we must have systems in place to treat such a patient. Therefore it is important to carry out training programs in all district hospitals across the country." ]]> <![CDATA[Entries open for Plant Genome Saviour Awards]]> https://biospectrumindia.com/news/95/4901/entries-open-for-plant-genome-saviour-awards.html https://biospectrumindia.com/news/95/4901/entries-open-for-plant-genome-saviour-awards.html Mon, 27 Oct 2014 12:37:58 +0530 The Protection of Plant Varieties and Farmers' Rights Authority (PPV & FRA) has called for Plant Genome Savior Community Award for the year 2013-14. PPV & FRA has been established by the Central Government under the Protection of Plant Varieties and Farmers' Rights Act, 2001. The Authority grants exclusive rights to the breeders and farmers who have bred, evolved or developed any variety. The PPV & FRA has instituted Plant Genome Savior Community Award. The Authority confers the award annually on the basis of shortlisting and site verification of the applications received from the community of farmers or farming community based organizations who have a long track record for conserving plant agro-biodiversity. Applications are now invited for the award, which is open to all Indian group of farmers, community of farmers, particularly the tribal and rural communities engaged in conservation, improvement and preservation of genetic resources of economic plants and their wild relatives particularly in the areas identified as agro bio-diversity hotspots. There shall be maximum of five awards in a year, consisting of a cash of rupees ten lakh each, a citation and a memento. The last date for submission of the application is December 27, 2014. The Authority also invites applications for the Plant Genome Savior "Farmer Reward" & "Farmer Recognition" from the farmers engaged in the conservation of genetic resources of landraces and wild relatives of economic plants and their improvement through selection and preservation and the material so selected and preserved has been used as donors of gene in varieties registerable under the PPV&FR Act, 2001 (53 of 2001). There shall be maximum of 10 rewards (comprising of citation, memento and cash of Rs One lakh each) and 20 recognitions (consisting of a citation and memento) in a year. It is essential for the applicants to forward their application through chairperson or secretary of the concerned panchayat biodiversity management committee or concerned district Agricultural Officer or Director of Research of concerned State Agriculture University or concerned District Tribal Development Office. Farmers whose applications are shortlisted for Reward and Recognition shall be required to deposit specified quantity of seeds or propagating material, which will be communicated later. ]]> <![CDATA[Polio eradication: India offers to help Pakistan]]> https://biospectrumindia.com/news/95/4915/polio-eradication-india-offers-to-help-pakistan.html https://biospectrumindia.com/news/95/4915/polio-eradication-india-offers-to-help-pakistan.html Mon, 27 Oct 2014 11:11:12 +0530 "I have been through the plan and find that the script is perfect. Pakistan has resolved to set up monitoring cells at the grassroots level. They are also talking of involving social groups, a strategy which worked wonderfully in India," said Dr Harsh Vardhan recently on the occasion of the World Polio Day, while welcoming Pakistan's prime minister, Mr Nawaz Sharif's recent declaration of adoption of a "National Emergency Action Plan-2014". The program will be fully state funded till 2018. India's social mobilization network for the fight against polio, which was originally conceived in Delhi in 1994 when Dr Harsh Vardhan was Health Minister of the state, has been lauded by all international organizations including World Health Organisation, UNICEF, Rotary International, and the United States Center for Disease Control. Dr Harsh Vardhan noted, "This particular model would stand Pakistan in good stead in her own anti-Polio drive. Unless all stakeholders in society, most importantly in Pakistan's context her religious clergy, are involved, it would be impossible to achieve total polio eradication." Recalling the joint statement issued at the end of the foreign minister-level talks in September 2012, Dr Vardhan pointed out that the two countries had already talked of institutionalizing cooperation on polio eradication through the mechanism of a Joint Working Group. There is also a technical level working group in the area of health cooperation. However, there was no significant progress on this front. India achieved full freedom from polio in January 2014 due to the fact that not a single new case had been detected since January 2011. Dr Vardhan said, "This year's World Polio Day is an emotional experience for me because it is the first to be observed since we became a polio free nation. When I launched the first Pulse Polio drive in Delhi in 1994 this seemed an impossible dream." In the context of Pakistan and Afghanistan, polio is just a bus ride away. Dr Harsh Vardhan said that special measures have been put in place at border crossings. These include vaccination facilities for travellers, travelling both ways to Pakistan and having emergency response plans in place along with teams to execute them. WHO's representative in India, Dr Nata Menabde said on the occasion, "We are using the lessons learnt from polio eradication to strengthen routine immunization in India. The polio infrastructure is now also being used for other health interventions, especially to protect our children from vaccine-preventable and other diseases." Mr Deepak Kapur, Rotary International's India PolioPlus chair, echoed Dr Harsh Vardhan's sentiments on Pakistan. He said that the fight against polio should be a global mission because no child in India is free till the disease is eradicated everywhere. "India's experience of eradicating polio proves that the obstacles which stand in the way of our ambitious goals for children can be overcome. UNICEF remains a committed partner in the polio eradication effort and our social mobilization network will continue to be active and harness this great momentum and leverage it for broader health initiatives for improving the lives of children," said Mr Louis-Georges Arsenault, UNICEF India representative. ]]> <![CDATA[BRAI Bill: needed or not needed? ]]> https://biospectrumindia.com/views/95/4999/brai-bill-needed-or-not-needed-.html https://biospectrumindia.com/views/95/4999/brai-bill-needed-or-not-needed-.html Fri, 24 Oct 2014 12:27:00 +0530 The BRAI bill has lapsed. What are the industry's reactions?Ms Kiran Mazumdar Shaw, CMD, Biocon: "The Biotechnology Regulatory Authority of India (BRAI) Bill has been stuck in limbo for years. Time and again our political leaders have failed to show the political will needed to take up this crucial piece of legislation for an informed debate in Parliament. Though the BRAI Bill was prepared after wide-ranging consultations among all stakeholders including the public, we have allowed strident activism and misleading campaigns to stall the passage of this bill. The result is that it will stifle the efforts of both private Indian companies as well as public sector institutions to come up with much-needed solutions using biotechnology. ABLE: The introduction of BRAI bill is long-overdue since the submission of Swaminathan Committee report on biotechnology regulations; unfortunately the BRAI bill lapsed with the end of tenure of last Lok Sabha. Industry hopes that the bill will be revived and tabled again before the Parliament soon especially since the Rajya Sabha Secretariat has done great work in conducting a significant consultation process and compiling and reviewing all the comments received from various stakeholders. Dr B V Ravi Kumar, MD, xCyton Diagnostics: This is extremely sad. Biotech requires a special attention as it is highly technical area at the same time very important for the general public and required an agency with domain knowledge to regulate. Agri Industry must be very upset. Are you satisfied with the draft of the bill placed in Parliament?ABLE: We believe that on a broad level the bill is a step in the right direction. We support a science-based, efficient, transparent, predictable and time-boundregulatory system that promotes scientific research and development of beneficial technology while providing adequate protection of the environment, human andanimal health. However, like any another bill, this too needs some discussion. Various stakeholders, including us, have given submissions on the bill draft and have suggested some changes. We hope the government will look into these submissions, and parliamentarians will take note of our views and suggestions while passing the same.Dr Swapan Kumar Datta, deputy director deneral (Crop Science): Division of Crop Science, ICAR: The draft bill submitted in Parliament is a reasonably good one and I am satisfied with that. However, there is always room for improvement and we could have gained some thoughtful feedback from the Parliamentarians during the debate of the bill. ]]> <![CDATA[GM Crops: To or not to, govt undecided!]]> https://biospectrumindia.com/views/95/4608/gm-crops-to-or-not-to-govt-undecided.html https://biospectrumindia.com/views/95/4608/gm-crops-to-or-not-to-govt-undecided.html Fri, 24 Oct 2014 10:48:00 +0530 Mr Joby Shekhar, assistant marketing manager, DuPont"As per my understanding, the farmer spends on an average Rs 7,000 on pestcontrol alone on per acre basis for crop protection products majorly for brinjalfruit and shoot borer alone. BT brinjal can provide solution in this regard in Indiaas majority of farmers growing this crop are marginal farmers, with low landholding and their technical know-how is also very low. Though there are somewonderful products like coragen available in Indian market, all farmers maynot have access to that technology due to various reasons. BT technology hasproven beyond doubt about its usefulness. USA is the country which has verystringent environment regulations and the farmers in the US and Europe areusing this technology to increase their productivity. In India we are seeing a lotof apprehension regarding this. But I personally believe that we should fully goahead with all in-house trials, on-field trials, gather data of its environmental footprints and leave it to the scientific community of our country to decide on that." Mr Santosh Nair, CEO, Camson Bio Technologies"Our Prime Minister is very bullish in terms of GM trials. He is more practicalby looking at the results in terms of agriculture production. With the explodingpopulation number, our agriculture production needs to go up by 70 percent.The question is why the GM trials were stopped? In fact it had lot of politicallymotivated vested interests. GM crops get into trouble when a gene from an animalis introduced into the plant kingdom. Today 95 percent of cotton that we growin our country is Bt Cotton. In our country farmers want to see the benefits ofcost and yield before they adopt a new method. They want to see it to believe it.This is a trend that is catching up." Dr M Ramasami, chairman, Rasi Seeds"Currently, there is good indication on allowing GM seeds and transgenic cropsin India but more clarity should emerge. We expect a fair and positive consideration of GM crops development with desirable agronomic traits in food crops such as rice. It will be a great advantageous for Indian farmers. Now our major strategy will be to introduce, for the benefit of Indian farmers, hybrids for food crop such as rice for insect pest resistance, yield enhancement, drought tolerance and nitrogen use efficiency. Cotton has been a very good example of adoption of biotech crop in India. Realizing the benefits, the cotton farmers have adopted GM technology that resulted in adoption of more than 95 percent of area under cotton in India within a span of 10 years, the production is more than doubled. A similar trend can be expected of other GM crops when it is allowed in our country. Rasi Seeds has been engaged in GM crop research for the past six years. We are optimistic to move forward in developing different crops with the encouraging support of the government. We have comparable and excellent capabilities in production of GM crops similar to world scientific community. We will also seek the collaboration of National and International agencies for desirable and viable technologies for GM crop development."Dr KC Ravi, vice president, Commercial Acceptance and Public Policy for South Asia, Syngenta "We are happy that the "Made in India" campaign mentions Biotechnology asone of the key sectors and the emphasis on GM hybrids is welcome. Farmingin India is getting complex and the farmers need all technologies including GMto combat the various abiotic stresses and climate change issues. India has immensely gained with the introduction of Bt Cotton hybrids and from a net importer the country is today a net exporter and is on the verge of becoming thesecond largest producer of cotton. As challenges of food security, shrinkingland and water shortage loom large, we need to help our farmers address thechallenges of retaining and enhancing their yeilds and income. ]]> <![CDATA[Accepted or Rejected: BRAI bill needed?]]> https://biospectrumindia.com/views/95/4472/accepted-or-rejected-brai-bill-needed.html https://biospectrumindia.com/views/95/4472/accepted-or-rejected-brai-bill-needed.html Thu, 23 Oct 2014 12:36:00 +0530 How important is BRAI bill for the biotech industry?Ms Kiran Mazumdar Shaw: Biotechnology can be a powerful tool in addressing India's challenges of meeting the food, fuel and healthcare needs of millions. It can play a very positive role in enhancing the quality of life of the people. However, multiple and complex regulations have been holding back all progress in the biotechnology sector. The Biotechnology Regulatory Authority of India (BRAI)was envisaged as the final authority on all issues related to the biotechnology industry in India. BRAI could have played a critical role in the country's progress in biotechnology by streamlining the regulatory structure. With the BRAI bill having lapsed, India has again lost an opportunity to unlock the immense potential of biotechnology. ABLE: The preamble to the BRAI Bill acknowledges the potential of biotechnology for India, stating that "modern biotechnology offers opportunities to address important needs related to agriculture, health, food production and environment." A bill recognizing the potential of biotechnology to contribute to India's health as well as substantially increase agricultural production to meet India's food, feed, fiber, and energy demands in the face of population growth is undoubtedly very important to the industry. ABLE supports the BRAI bill because of its potential to: Improve efficiencies in the regulatory process Create greater certainty and predictability for researchers, technology developers and the processing industry Encourage investment, research and development of products important for India Improve public information and awareness concerning modern biotechnology Dr BV Ravi Kumar: There is no government body with authority and domain knowledge. It is required if biotech sector has to grow. Biotech is equated with pharma and no special attention is paid. There are lot of apprehensions among people about biotech and government reacts to public protest with excessive regulation. We need a science-based regulation.Dr Swapan Datta: BRAI bill is important for science-based perception of moving forward with the genetically improved crops and for other biological material. Thebill shows the clarity, time-bound track record and accountability which is appreciated by the responsible Industry. How can the bill further foster the biotech sector?ABLE: While we sincerely feel that India already has a strong and well-developed regulatory framework to deal with all matters related to regulation and safe deployment of biotechnology products, the need of our times is to strengthen a regulatory regime in India to further promote innovation and development that is critical for our growing nation. This will help in bringing certainty and stability to regulatory environment governing the biotechnology sector that allows them to deliver the technological breakthroughs necessary to further our national interests.Dr Swapan Datta: Biotech sector usually works with responsibility and in a time-bound manner. The bill certainly will foster the motivation of the Industrialgrowth as a commitment with predictability. Have you approached the government regarding the lapse?ABLE: Yes, we have written to the Prime Minster and all the ministries concerned requesting to introduce and pass this bill after adequate discussion, and take steps to create and empower BRAI quickly to start its work.How soon can we expect the bill to be introduced or passed in the parliament?ABLE: This is very difficult to state; however, we wish this should happen as soon as possible, at least by the next budget session.Dr Swapan Datta: We would like to see the bill placed in Parliament soonest possible. ]]> <![CDATA[Advaxis appoints a new Chief Medical Officer]]> https://biospectrumindia.com/news/95/4385/advaxis-appoints-a-new-chief-medical-officer.html https://biospectrumindia.com/news/95/4385/advaxis-appoints-a-new-chief-medical-officer.html Thu, 23 Oct 2014 11:59:00 +0530 Advaxis has appointed Dr David J Mauro as executive vice president, chief medical officer. Dr Mauro brings to Advaxis more than 14 years of experience in oncology drug development, clinical research, and medical affairs. He most recently served as executive director, section head, Oncology Clinical Development at Merck & Co where he was involved in the strategic oversight and tactical implementation of clinical development and translational science for multiple programs within the oncology portfolio, including its recently approved PD-1 inhibitor, Keytruda (pembrolizumab). "Dr Mauro brings a wealth of experience overseeing the design, conduct and management of clinical trials," said Mr Daniel J O'Connor, president and CEO, Advaxis. He added, "His expertise will be essential as we advance the clinical development of our proprietary Lm-LLO cancer immunotherapies and prepare to initiate multiple clinical trials in the coming months. We are proud to have Dr Mauro join our team and look forward to his contributions as Advaxis establishes its position among the leaders in cancer immunotherapy." He will oversee the company's clinical programs, including the planned Phase 3 clinical trial in cervical cancer, the Phase I/II study with ADXS-HPV in combination with MedImmune's investigational anti-PD-L1 immune checkpoint inhibitor, and the Phase I/II study with ADXS-PSA in combination with Merck's approved PD-1 inhibitor, Keytruda, in metastatic, castration-resistant prostate cancer. "I am excited to join Advaxis at such an important time in the Company's development. I look forward to managing the planned Phase 3 clinical trial in cervical cancer, as well as the early stage monotherapy and combination therapy trials. Overall, I believe there is great potential in the medical community for cancer immunotherapies, and I look forward to advancing Advaxis's unique technology," stated Dr Mauro. ]]> <![CDATA[GM Crops: What does the industry say? ]]> https://biospectrumindia.com/views/95/7592/gm-crops-what-does-the-industry-say-.html https://biospectrumindia.com/views/95/7592/gm-crops-what-does-the-industry-say-.html Thu, 23 Oct 2014 11:10:00 +0530 Dr Ram Kaundinya, chairman, Association of Biotechnology Led Enterprises (ABLE-AG)"I don't regard it as a change in government's stance vis-a-vis thorough testing of genetically modified crops. What is important is the emphasis on research and development. While the funding to public research institutes continues,the regulations are still not clear. Trials by public institutes have come down inpast few years which is contrary to what previous UPA the regime had promised. Yet we feel that this mention of GM hybrids by present government is a strong statement. It is good that government is changing its approach. We are optimistic about future." Prof. M Mahadevappa, director, JSS Rural Development Foundation, Mysore"It is a positive development and I welcome the decision. I was disappointedwhen the GM field trials were put on hold in July this year. Now I am happythat the government is thinking positively on this matter and I urge stategovernments and NGOs to educate farmers about the benefits of GM technologyand adoption." Mr Swapan Kumar Datta, deputy director general, ICAR"Modi's support to GM crops is his long standing understanding, appreciationof science-based application for crop improvement strategy. As the CM of Gujarat,he allowed GM hybrid cotton first in India. Farmers from Gujarat and Indiabenefitted from this endeavor. Scientists from India and abroad will welcomehis visionary leadership. It is wonderful to see this positive move. Innovative science driven new activities will emerge and will boost in genetic gains for agricultural crop improvement. This raises the expectation that BRAI bill soonwould be placed in Parliament for further action towards approval." Dr TM Manjunath, prominent agri expert and consultant, former director,Monsanto Research Center"I am much happy about this development. It is good that the Modi governmentis instilling confidence in investors for agri technology among others. But we have been witnessing pressure from various quarters including activists on the government which otherwise was perceived as business friendly. The conflictingreports on GM trials have made us to keep our fingers crossed. While in principle, the GEAC's recommendations should have been accepted, the previous government too couldn't do so. And now we see that this government too couldn't go ahead. There is a need for hard decisions and I am sure that Mr Modi will do that in favor of agri-biotech industry. ]]> <![CDATA[A new strategy to treat heart attack discovered]]> https://biospectrumindia.com/news/95/4245/a-new-strategy-to-treat-heart-attack-discovered.html https://biospectrumindia.com/news/95/4245/a-new-strategy-to-treat-heart-attack-discovered.html Wed, 22 Oct 2014 10:56:00 +0530 A team of researchers including one of Indian-origin from the University of California, Los Angeles (UCLA) have discovered that fibroblasts (scar forming cells), have the ability to become endothelial cells. The new research paves way for a new strategy to treat heart attack. "It is well known that increasing the number of blood vessels in the injured heart following a heart attack improves its ability to heal. Our findings suggest the possibility of coaxing scar-forming cells in the heart to change their identity into blood vessel-forming cells, which could potentially be a useful approach for better heart repair," said Dr Arjun Deb, the study's senior author and an associate professor of medicine in the division of Cardiology at the David Geffen School of Medicine, UCLA. Through experiments in mice in which scar-forming cells in the heart were genetically labelled, researchers discovered that many of the fibroblasts in the heart's injured region changed into endothelial cells and contributed directly to blood vessel formation, a phenomenon they called mesenchymal-endothelial transition or MEndoT. Researchers identified a molecular mechanism that regulated MEndoT and found that administering a small molecule to augment MEndoT led to less scarring and allowed the heart to heal more completely. They plan to test similar small molecules in other models to determine whether the strategy could potentially be used to benefit humans. "There are remarkable similarities in the process of scarring in different organs after injury. Our hope is that this approach can be used to treat scar tissue in other organs as well," added Dr Deb. ]]> <![CDATA[J&J's blood cancer drug gets EU nod]]> https://biospectrumindia.com/news/95/4354/jjs-blood-cancer-drug-gets-eu-nod.html https://biospectrumindia.com/news/95/4354/jjs-blood-cancer-drug-gets-eu-nod.html Tue, 21 Oct 2014 13:52:59 +0530 Johnson and Johnson's (J&J) Janssen unit has announced that the European Commission (EU) has approved IMBRUVICA (ibrutinib) capsules, oral Bruton's tyrosine kinase (BTK) inhibitor. IMBRUVICA is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL), or adult patients with chronic lymphocytic leukaemia (CLL) who have received at least one prior therapy, or in the first line in the presence of 17p deletion or TP53 mutation in patients unsuitable for chemo-immunotherapy. The drug is co-developed by Cilag GmbH International (a member of the Janssen Pharmaceutical Companies) and Pharmacyclics Switzerland GmbH. "MCL and CLL with 17p deletion are usually challenging and difficult-to-treat blood cancers that do not respond well to conventional therapies. They usually rapidly progress during or soon after chemotherapy leaving patients with very limited treatment options and poor survival," said professor Peter Hillmen, Haematology, St James's University Hospital, who is an investigator in the IMBRUVICA CLL clinical trial. He added, "Being able to use IMBRUVICA as a single agent offers a new option and gives renewed hope for physicians and their patients." The approval of IMBRUVICA was based on data from the Phase III (RESONATE PCYC-1112) and Phase 1b-2 (PCYC-1102) studies in CLL, and the Phase II study (PCYC-1104) in MCL. "We are delighted the European Commission has approved IMBRUVICA as a new treatment approach, which could prolong the lives of patients with these complex blood cancers," said Ms Jane Griffiths, company group chairman, Janssen, Europe, Middle East and Africa (EMEA). She added, "This is a positive step forward for patients, and Janssen is committed to looking into further areas of unmet need in blood cancers where IMBRUVICA could improve outcomes." ]]> <![CDATA[SignalChem Lifesciences unveils new facility in Bangalore]]> https://biospectrumindia.com/news/95/6114/signalchem-lifesciences-unveils-new-facility-in-bangalore.html https://biospectrumindia.com/news/95/6114/signalchem-lifesciences-unveils-new-facility-in-bangalore.html Tue, 21 Oct 2014 11:04:10 +0530 At its new research facility, SignalChem will identify the cause of disease in each patient and determine a drug candidate that can potentially cure that disease. Not only will the research facility in Bangalore allow the company to address various diseases in different parts of the world, but it also increases the value of the company's therapies and helps increase its intellectual property. "Our province's biopharmaceutical sector is one of the fastest-growing in Canada, and the opening of this new research facility demonstrates that," said advanced education minister Mr Amrik Virk, who attended the facility's opening ceremony as part of Premier Clark's India Trade Mission. "I am proud to see British Columbia companies like this one making a global impact by making the necessary connections to expand their businesses into new markets." SignalChem was founded in 2004 and the company credits a large part of its success to having a smart business model of financial independence. In 2012, SignalChem grew to approximately 30 employees, and now employees 50 Canadians nationally and 95 people worldwide. "SignalChem has developed a technology platform to discover new drugs by exploiting protein kinases that are known to cause diseases such as cancer, inflammation or central nervous system disorders," said Dr Akash Mathur, SignalChem's chief business officer and resident director of SignalChem India. "These diseases impact populations worldwide, and opening a research and development facility in India is a key part of our plan to address these diseases. Upon success, our plan will be a breakthrough contribution by a Canadian biotech company." ]]> <![CDATA[World Ayurveda Conference on November 6 ]]> https://biospectrumindia.com/news/95/5005/world-ayurveda-conference-on-november-6-.html https://biospectrumindia.com/news/95/5005/world-ayurveda-conference-on-november-6-.html Tue, 21 Oct 2014 10:15:01 +0530 Announcing this at a press conference on October 20, 2014 at New Delhi, the health minister, Dr Harsh Vardhan said that the brand new All India Institute of Ayurveda (AIIA) coming up at Jasola, Delhi, will admit the first batch of post-graduate students during the academic year 2015-16. As per Dr Harsh Vardhan, "One of my first decisions was to approve the course content. I would like to see this develop into an institution comparable to the All India Institute of Medical Sciences-an AIIMS for Ayurveda." The 200-bed, seven-storey referral hospital, also coming up within the 10-acre campus, will begin to admit patients within six months from now. AIIA will emerge as a Centre of Excellence dealing with fundamental research, drug safety evaluation, standardisation, quality control and scientific validation of Ayurveda medicines. Elaborating on the format of the World Ayurveda Congress, Dr Vardhan said it will comprise 5 plenary sessions and 25 technical sessions on 15 research themes. In all, 750 scientific papers will be presented by scientists from India, Germany, Italy, USA, Argentina, Russia and many other countries. The international delegate assembly, International Seminar on Medicinal Plants organised by the National Medicinal Plant Board and a Buyer -Seller meet organised by Pharmexcil will be the added attraction of the Congress. The minister announced plans to make it a public event through the "Arogya Expo" which is envisaged as a "health mela" on Ayurveda, Yoga, Naturopathy, Unani, Siddha andHomoeopathy systems of medicine. This will be held at Hall No. 18 as a sideline event to the World Ayurveda Congress. About 500 pharma companies dealing in Ayurvedic medicines will be participating. "The public will be invited to see for themselves the wonders of our traditional medicines. We will open free consultation facilities where AYUSH doctors will examine all those who turn up and also distribute free medicines. Live Yoga sessions are also planned," Dr Harsh Vardhan said. ]]> <![CDATA[India being coaxed to relax patent laws: MSF]]> https://biospectrumindia.com/news/95/7345/india-being-coaxed-to-relax-patent-laws-msf.html https://biospectrumindia.com/news/95/7345/india-being-coaxed-to-relax-patent-laws-msf.html Mon, 20 Oct 2014 18:28:49 +0530 Medical Charity, Medecins Sans Frontieres (MSF) has condemned the US for mounting pressure on India's new government to relax the strict patent conditions, governing the country's pharmaceutical products. The charity said that India's generic drugs provided relief to millions of patients who cannot afford expensive branded versions. Ms Leena Menghaney, South Asia regional head of MSF's Access Campaign told a news report, "India has been the world's affordable drug safe-haven, the biggest source of affordable medicines." She added that the vast generic industry of the country has made it the world's pharmacy. MSF also accused the US authorities of seeking to get Indian Prime Minister, Mr Narendra Modi's government to lower India's patent eligibility bar. India's patent criteria are among the toughest in the world and the Indian law stipulates that drugs must "satisfy the test of novelty or inventiveness" to win patent protection. Ms Menghaney said that charities like MSF were hugely dependent on India's affordable drugs to meet the needs of its patients. Adding that India's patent laws are seen as models for Australia and Brazil, she said that the new government in India must stand firm and should not allow the patent regime to be dismantled. ]]> <![CDATA[US think-tank dares Indian government on legal action]]> https://biospectrumindia.com/features/95/4161/us-think-tank-dares-indian-government-on-legal-action.html https://biospectrumindia.com/features/95/4161/us-think-tank-dares-indian-government-on-legal-action.html Sun, 19 Oct 2014 10:55:00 +0530 The paper triggered severe reactions from the Indian government, pharmaceutical fraternity and industry bodies to the point of legal action against AEI. "The samples were collected between 2009 and 2012. But the paper does not clarify as to when and where were they tested and why did it take two years to write the report, asks Mr D G Shah, secretary general, Indian Pharmaceutical Alliance (IPA), when contacted by BioSpectrum. The publication has been authored by 4 PhD scholars namely Prof. Amir Attaran, faculty of law, Institute of Population Health, University of Ottawa, Canada; Dr Aparna Mathur and Dr Roger Bate, scholars, American Enterprise Institute; and Prof. Ginger Jin, Department of Economics, University of Maryland. According to the paper, Legatum Institute has funded the collection and testing of all the medicines. The study also recognizes that transportation and storage conditions could have impacted the quality of products tested. Coincidentally, the paper was released during Indian Prime Minister Narendra Modi's US visit. "The timing of this publication and the planned publicity in the media suggests that it was not a coincidence," justifies Mr Shah. On the other hand, Dr Aparna Mathur told BioSpectrum that the research paper is an academic paper on drug quality. "We had no political reason to write it, nor are we trying to defame Indian manufacturers. We report problems with some of the drug samples that we find, and we urge governments to crack down on poor quality drugs. It is beyond our understanding why the government would attack us for writing this paper instead of trying to go after the people who made the bad drugs." The authors said that around 1,470 samples of antibiotics and tuberculosis (TB) medicines claiming to be 'Made in India' were examined. "The samples were collected from five cities inside India as well as 17 low-to-middle-income countries outside of India, and tested for quality using the Minilab protocol," the authors quote. The examination led the researchers to conclude by saying that 10.9 percent of the tested products failed the basic assessment of active pharmaceutical ingredients (API). "And the majority of the failures are substandard (7 percent) as they contain some correct API but the amount of API is under-dosed," the paper reported. If the researchers' real concern were quality of drugs, they could have approached the drug regulatory authorities in India and the importing countries with full details of products, manufacturers, test methods and results, added Mr Shah. "However, apparently, that is not the intention. Instead, they have approached the media first to malign the country and its industry," he said. In another place, the scholars claim that most of these Indian-made drugs were of poorer quality when purchased from Africa than from India, or from Non-African mid-income countries such as China, Brazil, Turkey, Thailand, and Russia. In the paper, the authors have not revealed the names of the manufacturers owing to guideline commitments. "Instead of disclosing the names of products and their manufacturers which were allegedly found to be substandard, the study tarnishes the whole Indian pharmaceutical industry. This is unfair to the companies that ensure quality standards and to the country which has come to known as 'pharmacy of the world'. The government is therefore considering appropriate legal action," expressed Mr Shah. Earlier this year the USFDA discredited one such research study by the same researchers which claimed 'Impurities in Dozens of Generic Heart Drugs Made Overseas'. Mr Shah backed it up by saying, "The USFDA observed that the investigators themselves had contaminated the samples during their testing." The study was undertaken by Dr Preston Mason, a researcher at the Harvard-affiliated Brigham and Women's Hospital in Boston, USA. It was presented by Dr Mason at a congressional briefing in February 2014. When AEI witnessed intense reactions from India, it published an article as a counter-argument dated October 15, 2014, titled, 'India's Misguided Response to our Findings on the Quality of Drug Exports'. The authors counter-argue saying, "It is quite common for academics to publish studies that governments dislike, but not common for governments to sue them for it. However, as a recent paper in Foreign Policy noted, the Bharatiya Janata Party (BJP) and the Modi government have a nasty habit of suing and criminally prosecuting their opponents." To a query by BioSpectrum, one of the authors, Prof. Amir Attaran responded saying, "For my part, I can say that I have no fear at meeting India's government in court, if the Indian government is so foolish as to go there. Not even dictatorships such as Russia or North Korea are crazy enough to sue university academics for the research, but the available evidence is that India's government and pharma industry wish to be that intolerant and extremist." Mr Shah feels that this report is unlikely to tarnish the Indian drug industry. "Drug regulators in the mature markets and emerging markets have greater confidence in the capability of their organizations to ensure compliance with their standards. They would rather believe their own staff than this so called 'academic research', which is neither academic nor research," he opined. Prof. Attaran concluded by stating, "Little could do more to drive home the backwardness of India's drug regulatory institutions, and incestuous nature of the relationship between India's pharmaceutical industry and the government, than such an ill-liberal and ill-considered bit of litigation. Just the threat that has been made should embarrass Indian citizens profoundly. So my message to India's government is this: 'Bring it on if you dare'." ]]> <![CDATA[India reviews preparedness in wake of emerging global Ebola crisis]]> https://biospectrumindia.com/news/95/4974/india-reviews-preparedness-in-wake-of-emerging-global-ebola-crisis.html https://biospectrumindia.com/news/95/4974/india-reviews-preparedness-in-wake-of-emerging-global-ebola-crisis.html Sat, 18 Oct 2014 10:38:00 +0530 Chairing a high level meeting at New Delhi on October 16, the cabinet secretary Mr Ajit Seth reviewed the state of preparedness in the context of emerging global crisis on Ebola. In a video conference with chief secretaries and health secretaries of 19 states and UTs which have an international airport or a seaport, he took stock of the measures being undertaken for strengthening the preparedness, surveillance, and response system in the respective states. Those present included health secretary, home secretary, shipping secretary and secretaries or representatives of D/o health research, civil aviation, and external affairs were also present. The preparedness measures including infection control practices to be followed by the States and UTs have already been communicated to the states. The state Governments informed during the meeting that these protocols have been put in place and all inbound passengers are being screened. Till October 15, 2014, a total of 22,150 passengers have been screened, of which 7 were identified to be at medium risk and 56 at high risk while the others were categorized at low risk. Low risk passengers are given general advice on the virus while medium and high risk passengers are kept under observation for a further period of 30 days and their blood samples tested. A tracking system has been put in place under the Integrated Disease Surveillance Program (IDSP). State Governments informed that in accordance with the protocol, they have identified hospitals and isolation ward for Ebola treatment. Central teams have been asked to inspect the adequacy of preparations in these hospitals. ]]> <![CDATA[A new biotech policy in Karnataka]]> https://biospectrumindia.com/news/95/4583/a-new-biotech-policy-in-karnataka.html https://biospectrumindia.com/news/95/4583/a-new-biotech-policy-in-karnataka.html Sat, 18 Oct 2014 10:31:00 +0530 Karnataka government will announce a new biotechnology policy soon to attract higher investment in the biotechnology sector in the state, said reports. "Biotech companies in Karnataka, including Biocon, have contributed 26 percent of the country's biotech products worth $4 billion. More than half of the country's biotech companies are in Bangalore and it has emerged as the fourth largest biotech cluster in the world. The government aims to attract more investment in the sector," said Mr SR Patil, minister for IT, BT, Science and Technology in a statement. The government is also planning to establish a biotechnology incubation center to nurture biotech start-ups in Karnataka. It will encourage agriculture, horticulture-related biotech research activities. The government has earmarked Rs 8.5 crore to the Horticulture University, Bagalkot and Rs 6.5 crore to University of Agricultural Sciences, Dharwad for these purposes. ]]> <![CDATA[Do labour reforms help the biotech industry? ]]> https://biospectrumindia.com/news/95/6834/do-labour-reforms-help-the-biotech-industry-.html https://biospectrumindia.com/news/95/6834/do-labour-reforms-help-the-biotech-industry-.html Fri, 17 Oct 2014 15:24:24 +0530 The prime minister, Mr Narendra Modi in his speech at the Pandit Deendayal Upadhyay Shramev Jayate program, mentioned, "The "Shramev Jayate" initiatives were an essential element of the "Make in India" vision, as they would pave the way for skill development of youth in a big way, and even create an opportunity for India to meet the global requirement of skilled labour workforce in the years ahead." The new labour reform policy by the Modi government has brought in much sought changes. The necessity for 16 labor forms has been replaced with one form. An attempt has been made to bring in transparency to the labour inspection scheme. Inspectors can raid any firm, anytime but the report of inspection has to be given within 72 hours. Also, the access to provident fund (PF) accounts and insurance has been made easier. PF number has been made portable and can be shifted with jobs. Also, the minimum pension of one thousand rupees has been guaranteed. All these when implemented can bring confidence to the employees in the private sector. The biotech industry which has been caught in the web of a challenging regulatory environment may not list it as a major step for its way forward. However, it surely will boost the confidence and provide sense of security to the employees working in the sector. Dr Kiran Mazumdar Shaw, chairman and managing director, Biocon in a tweet comment to BioSpectrum's Rahul Koul remarked, "The biotech industry has regulatory challenges. It is not labour intensive." As per Dr Hemanth Nandigala, executive director, Virchow Biotech, "From whatever I have understood, there is a talk about operational ease. It is definitely a step in the right direction but I would certainly like to see the fine print. They talk about an ease of use and only on implementation can we evaluate the full potential." In its statement, Confederation of Indian Industries (CII) appreciated the government's move and said that it believes only a flexible, competitive, and efficient labour law can catalyze investment, growth, and employment. ]]> <![CDATA[Roche's IPF drug gets regulatory nod]]> https://biospectrumindia.com/news/95/3936/roches-ipf-drug-gets-regulatory-nod.html https://biospectrumindia.com/news/95/3936/roches-ipf-drug-gets-regulatory-nod.html Fri, 17 Oct 2014 15:21:39 +0530 Roche has announced that the US Food and Drug Administration (US FDA) has approved Esbriet (pirfenidone) as a treatment for idiopathic pulmonary fibrosis (IPF), a chronic lung disease. "This is a historic day for the people and their families in the United States who live with this deadly, incurable disease," said Ms Sandra Horning, chief medical officer and head of global product development. She added, "With today's approval of Esbriet in the United States, people with IPF finally have an FDA-approved medicine that may slow the worsening of the disease." The approval of Esbriet is based on data from a large, placebo-controlled Phase III study known as ASCEND and is supported by two other large Phase III trials known as CAPACITY 1 and 2. In the ASCEND study, more patients who received Esbriet had a delay in the decline of lung function compared to those who received placebo as defined by the primary endpoint of percent change in Forced Vital Capacity (FVC), a measure of how well the lungs work based on the amount of air one can exhale with force after inhaling as deeply as possible. Esbriet was developed by InterMune, a California-based biotechnology company which Roche acquired this year. "Until today, the 100,000 people with IPF living in the United States did not have an FDA-approved treatment," said Mr Jonathan Leff, executive vice president R&D, InterMune."Today's approval would not have been possible without the courage of patients, their families and the medical community that participated in the clinical studies of Esbriet," he added. ]]> <![CDATA[China-made Ebola drug sent to Africa ]]> https://biospectrumindia.com/news/95/7193/china-made-ebola-drug-sent-to-africa-.html https://biospectrumindia.com/news/95/7193/china-made-ebola-drug-sent-to-africa-.html Thu, 16 Oct 2014 17:19:00 +0530 JK-5, an experimental drug treat the raging Ebola virus in Africa, made by Chinese company Sihuan Pharmaceutical Holding Company Limited, which has not been tested so far on humans has been sent it large quantities to treat Chinese nationals in Africa who may contract the disease. The drug, developed by China's Academy of Military Medical Sciences, has been approved by the country's regulators only for emergency use. The drug is produced by Sihuan, a 13-year company promoted and run by medical professionals who had worked for the Chinese millary hospitals earlier. It is similar to Fuji Film-made Favipiravir, an influenza drug which has been found to be effective in treating Ebola symptoms. Sihuan's chief operating officer, Ms Jia Zhongxin, told Reuters on October 16 that few thousand doses of the drug JK-05 has been sent to Africa for use among aid workers. Like their Japanese counterpart, Sihuan is also hoping to the use the current conditions to do clinical trials on Ebola patients with emergency permissions from west African countries where the raging epidemic has killed more than 4000 people and infected over 10,00 people in the last few months. China has sent hundreds of health workers to the Ebola-hit region to help with the treatment. Sihuan, co-founded by Dr Che Fengsheng, who is its chairman and CEO, is a respected neurosurgeon who has served in various Chinese military hospitals before becoming an entrepreneurs. The company was listed for sometime in Singapore. It listed on the Hong Kong stock exchange in 2010. The company among the top 3 generic drug makers in China and specialized mainly in cardio vascular drugs. The military connection helped it to get access to the Ebola experimental drug. " Right now we are formulating a plan for clinical trials, and don't rule out the possibility of using African patients," Sihuan's COO Ms Jia told Reuters. Ebola has so far reached Europe and USA. If it reaches the Asian region, the two experimental drugs from China and Japan could come in handy. The region's other pharma powerhouse, India, has not done much on developing any treatment against Ebola so far. ]]> <![CDATA[Abbott sets up a new plant in Gujarat]]> https://biospectrumindia.com/news/95/3802/abbott-sets-up-a-new-plant-in-gujarat.html https://biospectrumindia.com/news/95/3802/abbott-sets-up-a-new-plant-in-gujarat.html Thu, 16 Oct 2014 15:25:00 +0530 To strengthen its presence in India, Abbott has opened a new manufacturing plant for nutrition products in Gujarat. The company reportedly invested Rs 450 crore in setting up this plant. "Abbott plans to locally source up to 80 percent of ingredients for new plant in India and is developing program to provide infrastructure and training to dairy farmers," the company said. The new plant will have a manufacturing capacity of 40 million pounds per annum. With this it is also adding 400 new jobs, taking its overall employee count in the nutrition segment in India to 1,150. Abbott Global Nutrition executive vice president Mr John Landgraf said, "We believe that our ongoing commitment represents an investment in a healthier India by providing high-quality nutritional products that will meet the health needs of local consumers" in a statement. The new facility is the company's third manufacturing site in India, with two others being pharmaceutical units in Baddi and Goa. ]]> <![CDATA[Solve routine issues at your own level: DBT ]]> https://biospectrumindia.com/news/95/3527/solve-routine-issues-at-your-own-level-dbt-.html https://biospectrumindia.com/news/95/3527/solve-routine-issues-at-your-own-level-dbt-.html Thu, 16 Oct 2014 12:30:01 +0530 In a letter dated September 19, 2014 and signed by DBT's director-administration, the directors and executive directors of all the autonomous institutes under the department have been asked to relove the routine issues at their level. Pointing to the routine administrative issues such as pay, fixation, leave encashment, etc being referred to it on regular basis, DBT has asked the respective administration officers of institutes to resolve these in consultation with the directors. However, the letter also mentioned that in case there is a matter that requires to be addressed by the DBT, it must be accompanied by a note with reasons for doing so also clearly mentioned. The move will surely ensure that the administrative capabilities of the insitutes which in the past have been depending on DBT for directions on even minor issues. ]]> <![CDATA[Need to replace existing health infrastructure says Dr Azim]]> https://biospectrumindia.com/news/95/3489/need-to-replace-existing-health-infrastructure-says-dr-azim.html https://biospectrumindia.com/news/95/3489/need-to-replace-existing-health-infrastructure-says-dr-azim.html Thu, 16 Oct 2014 11:10:18 +0530 "In case of the US, there was extensive use of technology during the H1N1 outbreak. They used it for getting real time information and increase preparedness. The number of searches by affected individuals on the subject was used to prepare the immediate response," stated Dr Sabahat S Azim, CEO, Global Healthcare Systems who was attending a panel discussion on healthcare at New Delhi recently. "On the same basis, in the next ten years, we have to see where we can use the information communication tools to deliver healthcare within the cost limits. Unfortunately in case of India, we are spending 200 percent lesser on health and we have to find a solution within the constraints," opined Dr Azim as he told BioSpectrum further, "I don't see a change in the existing public system suddenly. Since the existing system has not helped as it should have, there is a need for a change in paradigm." ]]> <![CDATA["We anticipate govt decision soon on GM issue"]]> https://biospectrumindia.com/news/95/5383/we-anticipate-govt-decision-soon-on-gm-issue.html https://biospectrumindia.com/news/95/5383/we-anticipate-govt-decision-soon-on-gm-issue.html Thu, 16 Oct 2014 11:07:07 +0530 "I don't regard it as a change in government's stance viz a viz thorough testing of genetically modified crops," stated Mr Ram Kaundinya, chairman of ABLE-AG which represents top agriculture biotechnology companies in his comments to the BioSpectrum over the phone. Mr Kaundinya points towards contradictory policies viz a viz GM crops. He elaborated, "What is important is the emphasis on research and development and while funding to public research institutes continues, the regulations are still not clear. Trials by public institutes have come down in the past few years which is contrary to what previous UPA regime had promised. Hope that changes." "Yet we feel that this mention of GM hybrids by present the government in its 'Make in India' campaign is a strong statement. It is good that government is changing its approach. We are anticipating a favorable decision and are optimistic about the future," said Mr Kaundinya. ]]> <![CDATA[Bangalore India Bio 2015 to be held in Feb 2015]]> https://biospectrumindia.com/news/95/5581/bangalore-india-bio-2015-to-be-held-in-feb-2015.html https://biospectrumindia.com/news/95/5581/bangalore-india-bio-2015-to-be-held-in-feb-2015.html Wed, 15 Oct 2014 18:13:00 +0530 This annual biotechnology (BT) event is organized by the Department of IT, BT and S&T, Government of Karnataka, Vision Group on Biotechnology and MM Activ Sci-Tech Communications. Eminent guests present at the curtain raiser were Shri S R Patil, minister for IT, BT and S&T, Planning and Statistics, Government of Karnataka; Dr Kiran Mazumdar-Shaw, chairperson, Karnataka's Vision Group on Biotechnology and CMD of Biocon; and Mr Srivatsa Krishna, IAS, secretary to Government, Department of IT, BT and S&T. Bangalore India Bio 2015 will consist of multi-track conferences, international trade show, distinguished lectures and talks, InterlinX biopartnering, bio excellence awards, bioquiz, and networking events. The trade show will have a special 'IT4BT Pavilion' to bring the IT and BT fraternity under one roof showcasing the latest technologies and to understand the industry requirements. The BIB is expected to witness about 100 exhibitors, 3000-plus business visitors, and international representations from more than 20 countries including the USA, France, Australia, Canada, Germany, Netherlands, Belgium, Korea, Taiwan, Malaysia and other Southeast Asian countries. The Bangalore India Bio 2015 will also allow young researchers to present their innovations through 'Poster Sessions - Walkway of Discovery'. For the first time, the event will also feature new sessions such as Top Guns Talks, Young Guns Roundtable, Global Biotech Conclave, and Secretaries Conclave. "The Prime Minister has initiated the 'Make in India' mission, which is about manufacturing and 'Swacha Bharat Abhiyan' dealing with cleanliness, hygiene and sanitation. In both these initiatives, biotechnology has a role to play. Through this, the government is keen to enact biomanufacturing and fermentation manufacturing, presenting India with enormous opportunities," added Dr Kiran Mazumdar-Shaw. "There are emerging opportunities where Bangalore-based companies are doing what it takes to become globally relevant in the area of biofuels and other aspects of biotechnology," Dr Mazumdar-Shaw further opined. Dr Mazumdar-Shaw also opined, "The round table conference called 'Secretaries Conclave' will help share, discuss and deliberate on issues, coming up with meaningful outcomes of what they believe should be the roadmap. This event will be a platform for young entrepreneurs, venture capitalists, and angel investors offering a glimpse of happenings inside the biotech sphere." Speaking about Bangalore being the IT and BT start-up capital, Dr Mazumdar-Shaw emphasized that most biotech start-ups today are genomics-led. "Genomics is one area where India can play a leadership role. Bangalore is privileged with a powerful ecosystem for genomics, in both public and private sectors." She said that the major challenge for India now is making genomics cost effective. She added, "India stands for high science at low cost. This is what we need to leverage and excel at and find a rightful place in the global biotech arena." Dr Mazumdar-Shaw also said that knowledge about biomedical technologies is growing by leaps and bounds. "The biomedical area is a vibrant space and a large number of start-ups are seen in this area. By combining IT and BT aspects, new diagnostic tools are developed. It is an exciting time for entrepreneurs, investors, and also for big companies to further build on their critical mass," she concluded. Mr SR Patil felt that agri-biotech needs to be developed first since India is predominantly an agricultural nation. "India's economy is dependent on agriculture. Farmers are the backbone of our nation. Unless agriculture is developed, farmers will not be empowered to strengthen our economy," he explained. ]]> <![CDATA["Primary healthcare important as first response to any epidemic"]]> https://biospectrumindia.com/news/95/6480/primary-healthcare-important-as-first-response-to-any-epidemic.html https://biospectrumindia.com/news/95/6480/primary-healthcare-important-as-first-response-to-any-epidemic.html Wed, 15 Oct 2014 10:28:00 +0530 As per Dr Bobby John, executive director, Global Health Advocates, "In India, there is an entity called as Central Bureau of Health Intelligence which has its own network to gather information. But whether it really is functional and of any use in these situations is not known" ,he told BioSpectrum in a one-on-one chat and added further, "Structure is there but we have failed to utilize it to collect data on a regular basis. In case of outbreaks such as Ebola, we require real time data which in our case is largely missing. The level of preparedness is equivalent to disasters such as earthquakes and floods but we have repeatedly displayed that we haven't been able to respond in a quick manner." Commenting on the government's encouragement to new drug research for these rare organisms, Dr John opined, "R&D into such diseases is ok but first we have to think about people who are infected. They always come up with basic symptoms such as fever, cough and breathing problems. They rather require primary attention and segregation on the basis of quick diagnosis. We lack orientation in that. Primary healthcare is as important as first response to any epidemic." Giving an example of Japanese Encephalitis in Western Uttar Pradesh where the cases were reported from everywhere, Dr John stated that we have not really learnt to devise mechanisms to monitor the situation regularly despite the availability of data. Otherwise there would have been no repetitions year after year as per him. "These comments are a broad generalization as we surely lack orientation on such issues," he concluded. ]]> <![CDATA[DBT has abundant resources says S&T minister]]> https://biospectrumindia.com/news/95/6575/dbt-has-abundant-resources-says-st-minister.html https://biospectrumindia.com/news/95/6575/dbt-has-abundant-resources-says-st-minister.html Tue, 14 Oct 2014 16:28:18 +0530 Dr Jitendra Singh, minister of State (Independent Charge) for Science and Technology and Earth Sciences, MoS PMO, Personnel, Public Grievances and Pensions, Space and Atomic Energy, said that the Government is giving a special thrust to Science and Technology and therefore one can easily describe the present time as the best time for the progress of Science in India. The Minister was inaugurating the 17th Annual Conference of Indian Society of Neuroradiology (INSR). Dr Jitendra Singh said that during the last four months of the present Government, several new strides have been made in the field of S&T and several new initiatives are being tried. These, he elaborated, include the decision to send scientists to take classes in schools and colleges, a special scheme called "KIRAN" for women to overcome a mid-career break, launch of commercial satellites in Space, launch of first indigenously constructed research ship "Sindhu Sadhana" in the ocean, sending school and college students abroad for interaction with nobel laurete scientists and setting up science parks as well as hi-tech science equipment in peripheral states like Jammu and Kashmir. An attempt has been made to reach out to the peripheral areas of the country, said Dr Jitendra Singh and in this respect, he cited the example of district Kathua located on the southern end of Jammu and Kashmir which has received the first ever bio-tech park of the state and is in the process of hosting a series of science exhibitions with social and economic dividends. Dr Jitendra Singh said that the Department of Biotechnology (DBT) has abundant resource material to offer medical researchers and MD or DM scholars doing their thesis and as an example, referred to some new areas like stem cell and gene research for which this department offers the best infrastructure. Referring to Neuroradiology as an upcoming new super-specialty, Dr Jitendra Singh said that a lot of morbidity and mortality occurring due to brain strokes earlier has now been overcome by new technologies but while we promote these new streams and new modalities of specialized treatment, it is important not to lose sight of the economic implications because in order to ensure that the benefits of the new technologies reach the lower strata of society, cost effectiveness will have to be ensured. Any new modality of medical management can achieve its avowed objective only when it has the capacity to benefit the poorest of the poor, he added. ]]> <![CDATA["Emerging infections not pre-determined"]]> https://biospectrumindia.com/news/95/5183/emerging-infections-not-pre-determined.html https://biospectrumindia.com/news/95/5183/emerging-infections-not-pre-determined.html Tue, 14 Oct 2014 10:29:00 +0530 "Irony is that we don't have an effective system. A robust functional health system is essential. Currently, there is an inability in the system to effectively tackle epidemics. Systems not ready at all levels. While the response at the center even if quick, will not be of much use until state governments too have a system in place. If you go down to state levels, preparedness remains an issue as the resources are not enough," Dr Manish Kakkar, senior health specialist, Public Health Foundation of India (PHFI) told BioSpectrum's Rahul Koul over the phone. "As far as the 1987 Epidemic Act is concerned, there is a major lacuna. There is an absence of a solid framework. Technical leadership has been working but the political system has failed," he stated further. Speaking about the role of the government, Dr Kakkar opined, "Several efforts have been reported from the Indian government. India was smart enough to invest into developing a system to deal with such issues. India was one out of many developing nations to contain H1N1. For example, Indonesia suffered on that account because of a lack of any such response. That is something that gave us experience. Consolidation of efforts happened. However, I feel it is too little and too late. We require more consolidation of efforts." Dr Kakkar feels that it is not possible to have quick responses to infections. He explained, "Emerging infections are not pre-determined. So we cannot fully prepare a response. It is also not possible to keep a solution ready for an infection which might not even be big enough. Pharma companies cannot invest heavily into such drugs as they too have business considerations and market demands." Dr Kakkar finds the GM issue not relevant here. He added, "We seem to be mixing issues here as not every drug is derived from crops. Although bypassing steps for quick passage through trials can hamper quality, in situations like this, policymakers had no other choice but to fast track the Z Mapp drug against Ebola." "PPPs are definitely required to increase preparedness against any such epidemic. As seen in case of Serum Institute of India and Bharat Biotech, the PPPs have helped in developing vaccines to tackle few key disease areas. That is the way as it reduces the burden on government which cannot care for all in a situation like in Indi," concluded Dr Kakkar. ]]> <![CDATA[Pfizer wins patent against fierce opposition]]> https://biospectrumindia.com/news/95/5187/pfizer-wins-patent-against-fierce-opposition.html https://biospectrumindia.com/news/95/5187/pfizer-wins-patent-against-fierce-opposition.html Tue, 14 Oct 2014 09:06:00 +0530 The drug is sold under the name Vfend in the US. The victory comes in after Ranbaxy, GM Pharma, Natco Pharma, and Ms Reena Manoharan, filed opposition against Pfizer claiming that 'the subject matter of the application is not novel, the matter lacks innovation, its utility is not substantive, its claims are indefinite and that no patent can be granted for a combination of known substances'. Pfizer disregarded the objectionable claims made by all the four parties. "The composition is industrially useful in the preparation of medicaments for the treatment of fatal fungal infection and the opposition arguments on non-patentability of the innovation and prior claiming of the invention are not sustainable", said the deputy controller of Patents and Designs to Business Standard. ]]> <![CDATA[Sun, Cadila remain tight-lipped on US price probe]]> https://biospectrumindia.com/news/95/4221/sun-cadila-remain-tight-lipped-on-us-price-probe.html https://biospectrumindia.com/news/95/4221/sun-cadila-remain-tight-lipped-on-us-price-probe.html Mon, 13 Oct 2014 17:35:00 +0530 "We are in the process of responding to the allegation. Fortunately, the issue will not have any impact on the company. Out of the two products questioned, one of them (Divalproex Sodium) is not being marketed in the US by Dr Reddy's. The US is a highly litigious country which we call our 'home market'. We need to get used to such allegations. We will cooperate with the US in all respect," said â€?Mr Kedar Upadhye, VP & head, global generics finance and investor relations, Dr Reddy's Laboratories, speaking exclusively to BioSpectrum. However, Sun Pharmaceuticals responded saying 'No comments' for BioSpectrum's email query on the issue. Similarly, Zydus Cadila didn't elicit any response to the email query as of on the evening of October 13, 2014. Shares of Sun was trading at Rs 803.55 each, down by Rs 15.25 or 1.86 percent, and Dr Reddy's was trading at Rs 2947.20, down by Rs 52.75 or 1.76 percent. Zydus Cadila was observed at Rs 1348.35, up by Rs 25.55 or 1.93 percent on October 13, 2014 on Bombay Stock Exchange (BSE) at 1640 hrs. ]]> <![CDATA['Global Biotechnology Market will be worth $414.5 billion by 2017']]> https://biospectrumindia.com/news/95/5643/global-biotechnology-market-will-be-worth-414-5-billion-by-2017.html https://biospectrumindia.com/news/95/5643/global-biotechnology-market-will-be-worth-414-5-billion-by-2017.html Mon, 13 Oct 2014 14:23:18 +0530 The global market for biotechnology shall grow at an average annual growth rate of CAGR 11.6 percent from 2012 to 2017 and reach a value worth $414.5 billion by the end of 2017, according to a report by Transparency Market Research, a global market intelligence company. The market was approximately $216.5 billion in 2011. The report also stated that the biotechnology market is estimated to observe substantial growth during the forecast period, i.e. between 2010 and 2017. The growth of the industry is estimated to increase during the forecast period as investments from around the world are anticipated to rise, especially from emerging economical regions of the world. According to the report, the market of bioagriculture, combined with that of bioseeds, is projected to reach a value worth $27.46 billion by 2018. Application-wise, the field of biopharmaceuticals dominated the global biotechnology market and accounted for 60 percent shares of it in the year 2011. Geographically, North America stood as the market leaders of the industry in the year 2011, accounting for an approximate 42 percent share of the global market. However, due to a rising focus on renewable chemicals, the region of Asia Pacific is estimated to grow at an annual CAGR of 14.1 percent during the forecast period. ]]> <![CDATA[BIRAC launches part 3 of Grand Challenges India program]]> https://biospectrumindia.com/news/95/5640/birac-launches-part-3-of-grand-challenges-india-program.html https://biospectrumindia.com/news/95/5640/birac-launches-part-3-of-grand-challenges-india-program.html Mon, 13 Oct 2014 14:11:43 +0530 Launched in 2013, Grand Challenges India is a collaborative effort of the Department of Biotechnology (DBT), Ministry of Science and Technology, Government of India; the Biotechnology Industry Research Assistance Council (BIRAC) and the Bill and Melinda Gates Foundation. Grand Challenges India has rolled out two successful initiatives: 'Achieving Healthy Growth through Agriculture and Nutrition' and 'Reinvent the Toilet Challenge' and is now launching a third, 'All Children Thriving'. Undertaken in partnership with the United States Agency for International Development (USAID), the program aims to ensure that all children not only survive but are also on a trajectory to live healthy and productive lives. Dr MK Bhan, former secretary, Department of Biotechnology (DBT), government of India announced this next phase of Grand Challenges India. 'All Children Thriving' funds for seed grants are $500,000 for up to two years and full grants are $2.5 million for up to four years and focus on innovative tools and approaches that will drastically alter the public health landscape. "On the 10th anniversary of the Grand Challenges meet, we must ensure that the underâ€?privileged have access to health services, good nutrition, and proper sanitation facilities. GCI's new call opportunity attempts to make positive changes in the lives of children in India. This is a major step forward in the DBTâ€?BIRACâ€?Bill and Melinda Gates Joint Mission", said Dr Vijay Raghavan, secretary, DBT, government of India and chairman, BIRAC. Over the past 10 years, the annual Grand Challenges Meetings have served as a platform for building the momentum required to tackle global health and development challenges and translating progress into impact. The annual meetings have convened world renowned researchers, government officials, and donors. On the 10th anniversary celebration, the Grand Challenges Meeting was jointly hosted by the Bill and Melinda Gates Foundation, Grand Challenges Canada, USAID, and The Wellcome Trust. "GCI's announcement indicates that we can make a difference when we work together, and our partnership with BMGF will help us find innovative solutions to address societal needs. DBT and BIRAC are proud to take forward the vision and initiatives of global thrust in developing innovative technologies to achieve sustainable gains to solve human health, food and nutritional inequities", said Dr Renu Swarup, senior adviser, DBT, Govt. of India and managing director of BIRAC. Further, Mr Girindre Beeharry, director, India Country Office, Bill and Melinda Gates Foundation stated, "By unlocking creative thinking and new approaches, this challenge aims to give all children the chance to live healthy lives and fulfil their potential. We applaud the Government of India's continued commitment to harnessing the power of innovation to overcome the problems facing India's mostvulnerable communities." Dr Sang E Lee, agricultural development officer, USAID India also added, "USAID is thrilled to have joined Grand Challenges India and to encourage the Government of India's support of appropriate innovative solutions to address the most challenging development problems of our time. It is our hope that India's leadership in this area will have broad reaching impacts in India and other countries facing similar challenges." ]]> <![CDATA[After GSK & Sanofi, now Novartis in bribery broth]]> https://biospectrumindia.com/news/95/5321/after-gsk-sanofi-now-novartis-in-bribery-broth.html https://biospectrumindia.com/news/95/5321/after-gsk-sanofi-now-novartis-in-bribery-broth.html Mon, 13 Oct 2014 14:06:31 +0530 It is alleged that the unnamed employee handed a health fund official a pleasure trip costing more than $1,000 in turn for supporting the selling of the company's drug. "Novartis can confirm that an employee was recently interviewed by authorities in Poland in connection with an ongoing enquiry," told Novartis to Reuters in an email statement. Recently GlaxoSmithKline faced similar bribery charges in China leading to a whopping £297 million fine payment. GSK also confessed that it is already up on investigating another of its allegations of bribery and corruption in the UAE. Adding to the chain of bribery scandals rocking the pharmacuetical world, in another nefarious case this October, drug-maker Sanofi said that it is carrying out an internal investigations for allegations of bribing doctors in Middle East and parts of Africa for forcing doctors to prescribe its drugs between 2007 and 2012. ]]> <![CDATA["Effectiveness of Z Mapp yet to be ascertained"]]> https://biospectrumindia.com/news/95/5635/effectiveness-of-z-mapp-yet-to-be-ascertained.html https://biospectrumindia.com/news/95/5635/effectiveness-of-z-mapp-yet-to-be-ascertained.html Mon, 13 Oct 2014 11:54:55 +0530 Padma Shri Dr Virander S Chauhan, former director, ICGEB, believes that there is an immediate need t o prioritize the creation of an effective system of response for Ebola like outbreaks in India. Replying to queries from BioSpectrum on whether India would be able to cope with an outbreak of such a large magnitude, Dr Chauhan explained, "While it could be possible in European states but in India where in case there is an unknown infection in a village in Tripura or Assam, we may not know it. There is a need as a nation, to prioritize the creation of such a system." He added further, "A surveillance system, after the bird flu epidemic broke, was set up in Singapore, Taiwan and Hong Kong. In India, we had a facility where the birds were collected from across India for culling and data collection. A Surveillance system is important. " On being asked about the recently prescribed drug for Ebola, Z Mapp, that was prepared on genetically modified tobacco leaves, Dr Chauhan remarked, "Z Mapp is not a drug. It is a mixture of two monoclonal antibodies and is given as a therapeutic. There is no reason to believe it will work or also whether it will not. It was administered to an Indian American who might have been taken care of in good conditions. Whether that will work in other settings needs to been seen. So, the GM connection at the moment is unnecessary. In any case, the bypassing of rules is even allowed by WHO too now in emergency cases. When a person is dying, there is no relevance of few regulations which can be kept aside for that moment." Dr Chauhan who is one of the emenient scientists of India, mentioned further, "There is no case of Ebola in Asia, Europe. Since, it doesn't transmit through air, it is easier to contain. However, overall we cannot prepare for all infections in advance. But no doubt the systems have to be in place. Response has to be there. We don't know what will strike where? Whether SARS or Bird Flu, it is just impossible to predict. When Ebola stuck Germany from Spain, it took one week for the country to sequence it. Sharing of information is important. World Health Organization (WHO) too has been advising that sharing such data is critical and must be reported and shared immediately without hiding it." ]]> <![CDATA['Antibiotics may be the cause of childhood obesity']]> https://biospectrumindia.com/news/95/4389/antibiotics-may-be-the-cause-of-childhood-obesity.html https://biospectrumindia.com/news/95/4389/antibiotics-may-be-the-cause-of-childhood-obesity.html Sun, 12 Oct 2014 13:23:00 +0530 According to a new study, giving antibiotics to young children increases the risk of childhood obesity. Children who had been given antibiotics at least four times before age two are more likely to be obese by the age of five, in comparison to children who had not received any antibiotics. The study published in the the journal JAMA Pediatrics analysed data from 64,580 children from health records collected between 2001 and 2013. Children who received the most antibiotics, four or more courses were 11 percent more likely to become obese compared to kids who have not received any. Lead author Dr L Charles Bailey, from the children's hospital of Philadelphia in the US said, "This was a small change, but as obesity is so common it's important to track down as many causes as possible." He added that obesity may also be caused by the disease which the child needed the antibiotics for. ]]> <![CDATA[Harvard offers new hope for diabetics]]> https://biospectrumindia.com/news/95/4384/harvard-offers-new-hope-for-diabetics.html https://biospectrumindia.com/news/95/4384/harvard-offers-new-hope-for-diabetics.html Sun, 12 Oct 2014 12:00:00 +0530 Researchers at the Harvard University have successfully produced insulin-producing beta cells using human embryonic stem cells. The stem cell-derived beta cells are currently undergoing trials in animal models, including non-human primates. Researchers believe that these cells can be ready for human transplantation within a few years. This research marks a major discovery for the treatment of type I diabetes. "There have been previous reports of other labs deriving beta cell types from stem cells, [but] no other group has produced mature beta cells as suitable for use in patients," said Professor Doug Melton of Harvard University, lead author of the study in a statement. He added, " We are now just one pre-clinical step away from the finish line." According to the researchers, the mice treated with the transplanted pancreatic cells are still producing insulin many months after being injected. Trials on laboratory monkeys are however needed before the technology can be transferred to humans. Experts in the field believe that this is an important advance for the field of diabetes and particularly people with Type 1 diabetes. The discovery could lead to the cure of the disease. ]]> <![CDATA[Cipla inks pact with Teva to market its products]]> https://biospectrumindia.com/news/95/4388/cipla-inks-pact-with-teva-to-market-its-products.html https://biospectrumindia.com/news/95/4388/cipla-inks-pact-with-teva-to-market-its-products.html Sun, 12 Oct 2014 11:48:00 +0530 Indian Pharma giant Cipla has entered into an agreement with Israel-based Teva Pharmaceuticlas. As per the agreement, Cipla Medpro will exclusively market Teva's pharmaceutical products portfolio in South Africa. Mr Subhanu Saxena, managing director and global CEO, Cipla said, "Cipla believes that the collaboration with Teva reaffirms its commitment of advancing healthcare to all South Africans" in a statement. The collaboration will focus on oncology, central nervous system, women's health, cardiovascular, ophthalmology, and other speciality products. ]]> <![CDATA[AstraZeneca's asthma drug shows promising results]]> https://biospectrumindia.com/news/95/5264/astrazenecas-asthma-drug-shows-promising-results.html https://biospectrumindia.com/news/95/5264/astrazenecas-asthma-drug-shows-promising-results.html Sat, 11 Oct 2014 14:54:00 +0530 AstraZeneca's (AZ) benralizumab, a novel investigational monoclonal antibody for treatment in patients with severe, uncontrolled asthma and elevated levels of eosinophil has shown a positive result in mid-stage, phase IIb clinical study. The trial met its primary endpoint, with patients on benralizumab experiencing a statistically significant reduction in their asthma exacerbation rate versus placebo over a year. The study showed that the drug reduced asthma exacerbations by approximately 40-70 percent, depending on the dose received and baseline blood eosinophil level. Mr Bing Yao, head of respiratory, inflammation and autoimmunity operations at AZ's MedImmune unit said, "Asthma is a highly heterogeneous disease and this data advances our understanding of patient subtypes, potential biomarkers, and targeted therapies." ]]> <![CDATA[HC strong on proposed AZ delisting]]> https://biospectrumindia.com/news/95/5246/hc-strong-on-proposed-az-delisting.html https://biospectrumindia.com/news/95/5246/hc-strong-on-proposed-az-delisting.html Fri, 10 Oct 2014 14:27:55 +0530 According to Mint, the Bombay high court has stayed the proposed delisting of AstraZeneca Pharma India Ltd after two minority shareholders moved the court against the plan following an investigation by the market regulator that found alleged evidence of "collaboration" between the company's Swedish parent AstraZeneca Pharmaceuticals AB and the Elliott group of investors in its offer for sale (OFS) last year. ]]> <![CDATA["Govt has to take hard decisions," feels Dr Manjunath]]> https://biospectrumindia.com/news/95/5248/govt-has-to-take-hard-decisions-feels-dr-manjunath.html https://biospectrumindia.com/news/95/5248/govt-has-to-take-hard-decisions-feels-dr-manjunath.html Fri, 10 Oct 2014 13:10:54 +0530 Speaking to BioSpectrum, Dr TM Manjunath, agri-consultant and former director, Monsanto Research Center, remarked, "I am much happy about this development. It is good that Modi government is instilling confidence in investors for agri technology among others. But we have been witnessing pressure from various quarters including activists on the government, which otherwise was percieved as business friendly. Commenting on the genetically mdified (GM) crops issue, Dr Manjunath stated, "The conflicting reports on GM trials have made us keep our fingers crossed. While in principle, the GEAC's recommendations should have been accepted, the previous government too couldn't do so. And now we see that this government too couldn't go ahead. There is a need for hard decisions and I am sure that Mr Modi will do that in favour of agri-biotech industry." "If we can reach Mars then agriculture which feeds us surely has to be taken care of. I am hopeful about that," he concluded on an optimistic note. ]]> <![CDATA[AstraZeneca ends collaboration with Targacept]]> https://biospectrumindia.com/news/95/5638/astrazeneca-ends-collaboration-with-targacept.html https://biospectrumindia.com/news/95/5638/astrazeneca-ends-collaboration-with-targacept.html Fri, 10 Oct 2014 12:19:00 +0530 AstraZeneca terminated its collaborative research and license agreement with Targacept, a North Carolina-based, US biopharmaceutical company. The collaboration started in 2005, and is now terminated after nearly 9 years. The termination becomes effective 90 days after October 8, 2014. The decision will end the collaboration on TC-6683 compound. All the rights and licenses on this compound will be returned to Targacept. ]]> <![CDATA[Indian pharma industry makes its presence felt at CPhI Worldwide 2014]]> https://biospectrumindia.com/news/95/6315/indian-pharma-industry-makes-its-presence-felt-at-cphi-worldwide-2014.html https://biospectrumindia.com/news/95/6315/indian-pharma-industry-makes-its-presence-felt-at-cphi-worldwide-2014.html Fri, 10 Oct 2014 10:29:22 +0530 On the back of an aggressive branding showcase managed by India Brand Equity Foundation (IBEF), the Brand India Pharma campaign made its presence felt on the first day of CPhI Worldwide 2014. With a 360-degree strategy, IBEF has been leading the Brand India Pharma campaign since its launch in March, 2012 under the aegis of the Department of Commerce. This is the third consecutive presence of the campaign at CPhI Worldwide, one of the most prestigious pharmaceutical events across the globe. Around 230 Indian companies are participating at CPhI Worldwide this year. CPhI Worldwide is the largest pharmaceutical trade exhibition and is being held from October 7-9, 2014 in Paris. Present at the India Pavilion were Mr Rajeev Kher, commerce secretary, Government of India along with Mr Arun Kumar Singh, ambassador of India to France; Dr G N Singh, drugs controller general of India; Mr B P Pandey, additional secretary and financial advisor, Department of Commerce, Government of India; Mr Sudhanshu Pandey, joint secretary, Department of Commerce, Government of India; Ms Aparna Dutt Sharma, CEO, IBEF; Mr Amruth Rao, Licensing Authority, DCA, Telangana; Mr H G Koshia, commissioner, Food and Drug Control Administration, Gujarat and Dr P V Appaji, director general, Pharmaceuticals Export Promotion Council of India (Pharmexcil) in the presence of major Indian pharmaceutical companies in Hall 6 at the Paris Nord Villepinte, France. "The Indian pharmaceutical industry stands with the full support of the Government of India. For instance, our increasing participation at global exhibitions like CPhI Worldwide demonstrates the commitment to the sector," said Mr Rajeev Kher. "There are around five Indian companies in the list of top 20 global generic companies. Indian companies are looking at making healthcare accessible and affordable for the global population," said Mr Sudhanshu Pandey. "This is one of the most expansive showcases from the Indian pharmaceutical industry at CPhI Worldwide. We are confident that the focused activities will deliver a marked improvement in the awareness levels of the global industry," said Ms Aparna Dutt Sharma. The Brand India Pharma also made an impacting presence at the Pre-Connect Congress that took place on October 6, 2014. Speakers like Mr Sudhanshu Pandey from the Department of Commerce, Dr Appaji from Pharmexcil, Ms Nithya Balasubramanian, head, Global Portfolio Management, Cipla and Mr C Bharat Reddy, executive director, MSN Laboratories shared perspectives from India on various topics ranging from comparative view of the Chinese, Indian, and Brazilian API sourcing markets, strategic alliances and partnering, changing outsourcing strategies, strategic alliances of pharmaceutical companies and the future of healthcare business models. IBEF has arranged coordinated meetings of the high-level Indian delegation with the global pharmaceutical media and Indian companies during the three days of the event. An interactive session of the Indian delegation with the local French media and industry was jointly organized by IBEF and The Embassy of India in Paris on October 6, 2014. India's positioning as a responsible healthcare provider has found resonance amongst the meetings held during the Pre-Connect Congress and the first day of the exhibition. Major Indian companies have adopted the Rx India Responsible Healthcare in their pavilions making it a consolidated effort from India to spread awareness about the strengths of the Indian pharmaceutical industry. The focused activities undertaken by IBEF as part of the Brand India Pharma campaign this year at CPhI Worldwide are expected to increase awareness about the Indian pharmaceutical industry amongst the global stakeholders. ]]> <![CDATA[Sun, Dr Reddy's named in US Congress price probe]]> https://biospectrumindia.com/news/95/5145/sun-dr-reddys-named-in-us-congress-price-probe.html https://biospectrumindia.com/news/95/5145/sun-dr-reddys-named-in-us-congress-price-probe.html Thu, 09 Oct 2014 17:04:36 +0530 The US Congress has written to 14 generic drug manufacturers, including three top Indian firms - Sun Pharmaceutical Industries, Dr Reddy's Laboratories and Cadila Healthcare - following an abnormal rise in prices of 10 generic medicines. According to a press release posted in United States Senator for Vermont, Bernie Sanders website, 14 separate letters have been sent to 14 pharmaceutical companies including Indian companies Dr Reddy's, Cadila Healthcare and Sun Pharmaceuticals. "It is unacceptable that Americans pay, by far, the highest prices in the world for prescription drugs. Generic drugs were meant to help make medications affordable for the millions of Americans who rely on prescriptions to manage their health needs. We've got to get to the bottom of these enormous price increases," commented Mr Sanders, chairman, Senate Healthcare Subcommittee, and Mr Cummings, ranking member of the House Oversight Committee. Other companies include, Actavis, Apotex, Endo International, Global Pharmaceuticals, Heritage Pharmaceuticals, Lannett Company, Marathon Pharmaceuticals, Mylan, PAR Pharmaceutical Companies, Teva Pharmaceutical, West-Ward Pharmaceutical, and Zydus Pharmaceuticals USA. The Senate's Healthcare Subcommittee pointed an example of the price hike for Albuterol Sulfate used to treat asthma and other lung conditions. The average cost for a bottle of 100 pills was $11 last October. However, the average charge by this April had shot up to $434. An antibiotic, Doxycycline Hyclate, cost $20 last October for a bottle of 500 tablets. By April, the price was $1,849, said the statement. According to CNBC TV18, stock prices of Sun Pharma and Dr Reddy's Labs fell as much as 5 per cent and 3.7 percent intraday, respectively after the US Congress began investigation into price hikes. Dr Reddy's have been questioned for Divalproex Sodium & Pravastatin Sodium; and Sun Pharmaceuticals for the same Divalproex Sodium along with Doxycycline Hyclate & Albuterol Sulfate. In the letters, the companies have been requested to produce the following documents and information:(1) Total gross revenues from the company's sales of these drugs;(2) The dates, quantities, purchasers, and prices paid for all sales of these drugs;(3) Total expenses relating to the sales of these drugs, as well as the specific amounts for manufacturing, marketing and advertising, and purchases of active pharmaceutical ingredients, if applicable;(4) Sales contracts or purchase agreements for active pharmaceutical ingredients for these drugs, including any agreements relating to exclusivity, if applicable;(5) A description and valuation of the specific financial and non-financial factors that contributed to your company's decisions to increase the price of these drugs;(6) Any cost estimates, profit projections, or other analyses relating to the company's current and future sales of these drugs;(7) Price of this drug in all foreign countries or markets, including price information for the countries paying the highest and lowest price; and(8) The identity of company official(s) responsible for setting the price of these drugs over the above time period. ]]> <![CDATA[India, the US to develop new vaccines for endemic diseases]]> https://biospectrumindia.com/news/95/5135/india-the-us-to-develop-new-vaccines-for-endemic-diseases.html https://biospectrumindia.com/news/95/5135/india-the-us-to-develop-new-vaccines-for-endemic-diseases.html Thu, 09 Oct 2014 15:51:48 +0530 The recent visit of the Indian Prime Minister Mr Narendra Modi to the US, has turned out to be a game changer for the healthcare sector. The meeting has spurred efforts to foster the biotech industry and develop new and affordable vaccines to combat endemic diseases like dengue, malaria, and tuberculosis. A top government official of India said that the country's Ministry of Health and Family Welfare, the Department of Biotechnology and the US National Institutes of Health will collaborate to develop novel vaccines for these diseases. The official further said that the countries will also collaborate to develop novel cancer therapies. The US National Cancer Institute has agreed to help develop the upcoming National Cancer Institute at the Jhajjar (Haryana) campus of All India Institute of Medical Sciences (AIIMS). The US will also help in improving water and sanitization facilities for 500 Indian cities, added the official. ]]> <![CDATA["India needs dedicated central agency to handle epidemics"]]> https://biospectrumindia.com/news/95/6765/india-needs-dedicated-central-agency-to-handle-epidemics.html https://biospectrumindia.com/news/95/6765/india-needs-dedicated-central-agency-to-handle-epidemics.html Thu, 09 Oct 2014 11:01:21 +0530 The recent Ebola virus outbreak has posed many challenges across the globe and the main reason behind this is ignorance and lack of preparedness to deal with it. As per Dr BR Das, â€?president - Research and Innovation, mentor - Molecular Pathology and Clinical Research Service, SRL Diagnostics, "Before the emergence of healthcare threats such as SARS, Bird Flu, and Novel Swine Flu, India's response during such epidemics was ad-hoc and pretty delayed. Nevertheless post SARS, India is fast learning to handle such challenges successfully. Depending on the nature of the epidemic, apex organizations involved in medical research such as Indian Council for Medical Research (ICMR), National Institute of Communicable Diseases (NICD), National Center for Disease Control (NCDC) guide and govern the activities. Strategically, they work with most states recruiting Medical Officers and various cadres of Health Care Providers from Medical Colleges, District Hospitals and Community Healthcare Centers (CHCs) to disseminate the steps and control measures during epidemic situations." However, Dr Das added, "Though presently there is a fair progress in our response to epidemics, there is still a need to establish a central agency which could effectively coordinate with all concerned organizations and which can continuously and proactively monitor for any possible health contingencies." On being asked about what should be the key take-away lessons for India from the Ebola outbreak, Dr Das feels that it is a wake-up call to build strong public health systems, including disease surveillance measures; early warning systems and improved epidemic preparedness measures. As per Dr Das, "the management of such large magnitude and relatively novel disease outbreaks is beyond the purview of our current healthcare system and emergency response mechanisms. Like any developing nation, India is majorly dependent on the technical, operational and financial support from global health agencies such as World Health Organization (WHO), Red Cross, and United State's Center for Disease Control (CDC). Indian healthcare authorities are fast realizing the need and hopefully will learn from certain SEA countries for developing rapid response mechanisms." Talking about the reasons for the lack of effective cure which as per Dr Das are complex, he said, "Though researchers are actively involved in developing effective drugs and vaccines against potentially hazardous viruses and bacteria, unfortunately there is a huge gap in funding this research till the last phase of development. Particularly for emerging infections which are common to low economic regions such as Africa and Asia. Similarly drug and vaccine trials in tropical regions with limited infrastructure are difficult and costly. Major pharmaceutical companies have shown little interest in developing effective treatments for emerging infections. As there's no incentive for the commercial risks of research and companies naturally prefer to focus on diseases that can sustain large markets of wealthy regular users. Last but not the least, most of these emerging viruses and bacteria mutate rapidly which could make them more transmissible or reduce the effectiveness of the drugs and vaccines in pipelines." Elaborating on the government's role, Dr Das told BioSpectrum, "In order to encourage new drug research and success outcomes, the government needs to arrange for funding and collaborative opportunities, linking National and International research groups. Also the government needs to offer tax incentives to undertake research activities pertaining to new drug development that would otherwise not be regarded as profitable. Apart from this, the government can explore adopting BRAT framework a way to "move toward an assessment that seeks to incorporate all relevant aspects of benefit and risk." The idea is to develop clearer guidelines for regulators in making decisions about the benefits and risks of various drugs. Ultimately, this approach could also be used to give clinicians and patients more discretion regarding the risks they are willing to bear with the newly developed drugs." Dr Das felt that the PPP model is the right way to go forward. "India's health ministry has a plan in place to deal with emerging health emergencies. However, it is important to keep such plans 'dynamic', through PPP models. The private and public sectors comprising diagnostic companies, R&D centers, biotechs, academia, governments, regulators, and healthcare professionals need to work together. The government should immediately engage the R&D set-ups in diagnostic industry biotechnology sector and various associated governmental agencies to undertake research on emerging health threats." "In fact, the 2009 H1N1 pandemic situation is an excellent example of how public and private organizations can be join forces to handle epidemic of any magnitude. A similar collaboration can be extended proactively for conducting research and monitoring emerging health threat trends in India," concluded Dr Das. ]]> <![CDATA[ Indian to lead drug discovery at Allied-Bristol]]> https://biospectrumindia.com/news/95/5031/-indian-to-lead-drug-discovery-at-allied-bristol.html https://biospectrumindia.com/news/95/5031/-indian-to-lead-drug-discovery-at-allied-bristol.html Thu, 09 Oct 2014 09:30:00 +0530 Bristol Life Sciences, a jointly owned enterprise between Allied Minds and Bristol-Myers Squibb announced that Dr Satish Jindal will head its efforts to identify and foster development of biopharmaceutical innovations from top US university research institutions. Dr Jindal was formerly the VP of R&D within Bristol-Myers. "We have a unique opportunity to create novel medicines in partnership with Bristol-Myers Squibb," said Dr Jindal, who will be based in Boston. "Through this innovator model of Allied-Bristol Life Sciences, we can fill a critical gap that exists in translating highly important scientific discoveries from leading academic research institutions," he commented. ]]> <![CDATA[DaVita to expand its business in India]]> https://biospectrumindia.com/news/95/6410/davita-to-expand-its-business-in-india.html https://biospectrumindia.com/news/95/6410/davita-to-expand-its-business-in-india.html Wed, 08 Oct 2014 15:12:52 +0530 DaVita HealthCare Partners, a leading international provider of kidney care services has announced that it will expand its international service offerings beyond kidney care with a strategic investment in India's largest independent primary care and multi-specialty chain, Express Clinics. "India is a very important part of our growth plans in Asia-Pacific," said Mr Dennis Kogod, president of DaVita HealthCare Partners' international operations. He added, "Twenty-six primary care centers in addition to DaVita's network of 13 dialysis centers in India represent a large footprint to serve patients." DaVita HealthCare Partners will take a strategic stake in Express Clinics which currently operates 26 clinics located in Pune, Delhi, Mumbai and Bengaluru. "We are recognized as the leading provider of dialysis services in India and we are proud to now extend that record of clinical excellence into Indian primary and multi-specialty care services," said Mr Atul Mathur, president of DaVita HealthCare Partners in the Asia-Pacific region. Express Clinics offers a variety of services including consultations with general physicians and specialists, pathology and radiology, and custom health packages. The strategic partnership with DaVita HealthCare Partners will enable the company to deepen its footprint in current markets and enter new ones. Mr Brij Sharma, founder of Express Clinics said, "We are extremely excited that this partnership provides Express Clinics the ability to leverage DaVita HealthCare Partners' expertise in creating best-in-class clinical outcomes. With the support of this partnership, we will continue to grow and deliver comprehensive, high-quality health care services to a broader patient population in India." ]]> <![CDATA[Merck, ICR, Wellcome Trust to co-develop cancer drugs]]> https://biospectrumindia.com/news/95/4984/merck-icr-wellcome-trust-to-co-develop-cancer-drugs.html https://biospectrumindia.com/news/95/4984/merck-icr-wellcome-trust-to-co-develop-cancer-drugs.html Wed, 08 Oct 2014 15:11:14 +0530 Merck Serono, the biopharmaceutical division of Merck, The Institute of Cancer Research (ICR), and the Wellcome Trust has announced a co-development and license agreement to identify inhibitors of tankyrase, an enzyme of the poly (ADP-ribose) polymerase family (PARP). Some of the most promising advances in cancer research have been small-molecule inhibitors of PARP enzymes. The collaboration will be jointly funded by Merck Serono and the Wellcome Trust. In a joint effort, a team led by Dr Chris Lord and Professor Alan Ashworth at the ICR and a research group at Merck Serono will aim to progress chemical compounds that have emerged from both organisations' tankyrase inhibitor programs towards clinical development. At the end of the collaboration period, Merck Serono will take over full responsibility for the selected clinical development candidate, with the goal of bringing a new cancer therapeutic drug to patients. Dr Chris Lord, team leader in the division of breast cancer research at ICR said, "Tankyrase inhibitors provide a unique opportunity to target one of the most common characteristics of cancer cells - their dependency on the so-called 'Wnt signaling' pathway. Both Merck Serono and the group at the ICR have already made notable progress in developing tankyrase inhibitors. Working with Merck Serono will allow us to jointly accelerate our program with the aim to ultimately make tankyrase inhibitors available to cancer patients." "We are delighted to work together with Dr Chris Lord and Professor Alan Ashworth. With this partnership, we aim to harness the already well advanced tankyrase programs at both ICR and Merck Serono and hope to ultimately translate these in to novel treatment options for cancer patients. We will build on a joint compound base of potent tankyrase inhibitors and will leverage both sites' scientific knowledge about the 'Wnt pathway' that plays a major role in signal transduction for tumor growth", said Dr Andree Blaukat, head of the translational innovation platform oncology at Merck Serono. He added, "The interest of the Wellcome Trust shows its belief in our researchers' scientific data. It also shows the importance of academia-industry collaboration models in pharmaceutical development to progress the most promising investigational compounds into clinics with the aim of bringing them to patients." Dr Ted Bianco, director of innovations at the Wellcome Trust said, "We welcome the strategic collaboration with Merck Serono, which brings together a world-leading academic drug discovery group, and an industry partner with such a strong commitment to oncology, to give the program the best possible chances of success." ]]> <![CDATA[Sanofi probes claims of bribery]]> https://biospectrumindia.com/news/95/5418/sanofi-probes-claims-of-bribery.html https://biospectrumindia.com/news/95/5418/sanofi-probes-claims-of-bribery.html Wed, 08 Oct 2014 15:07:00 +0530 This news arrives just in time when GSK suffered a humiliating defeat of paying £297 million as fine last month for bribing doctors in China. According to Reuters, Sanofi is said to have bribed doctors in Kenya and East African countries forcing them to prescribe its drugs. "The investigation is still ongoing and is expected to take some time given that the allegations date back seven years," Sanofi said in a statement. ]]> <![CDATA[Syngenta appreciates 'Make in India' campaign]]> https://biospectrumindia.com/news/95/5137/syngenta-appreciates-make-in-india-campaign.html https://biospectrumindia.com/news/95/5137/syngenta-appreciates-make-in-india-campaign.html Wed, 08 Oct 2014 11:45:07 +0530 Expressing his happiness on behalf of Syngenta, Dr KC Ravi, vice president, Commercial Acceptance and Public Policy for South Asia, mentioned, "We are happy that the "Made in India" campaign mentions biotechnology as one of the key sectors and the emphasis on GM hybrids is welcome. Farming in India is getting complex and farmers need all the technologies including GM to combat the various abiotic stresses and climate change issues. India has immensely gained with the introduction of Bt Cotton hybrids and from a net importer the country is today a net exporter and is on the verge of becoming the second largest producer of cotton in the world." On challenges such as food security, shrinking land, and water shortage that loom large, Dr Ravi stated that India needs to make available the entire tool box - from genetics, chemistry and biology to our farmers to help them address the challenges of retaining and enhancing their yeilds and incomes. "The efficacy and safety of GM have been empirically proven through many scientific studies. We are happy there are indications that the government is keen to allow wider diffusion of hybrid seeds including GM technology. The government has announced several progressive measures and we hope that the special focus on GM hybrids would further boost the agriculture sector," Dr Ravi told BioSpectrum and stressed that it is crucial that the present impasse is overcome quickly and at least the field trials begins in right earnest. ]]> <![CDATA[Cambridge Consultants develop smartphone operated insulin injection pen]]> https://biospectrumindia.com/news/95/5631/cambridge-consultants-develop-smartphone-operated-insulin-injection-pen.html https://biospectrumindia.com/news/95/5631/cambridge-consultants-develop-smartphone-operated-insulin-injection-pen.html Wed, 08 Oct 2014 09:27:00 +0530 Product development firm Cambridge Consultants has designed an injection pen for diabetes patients that aims to make daily management of the disease an easier, more accurate task. The KiCoPen device is designed to capture the exact dose delivered and send the information to an associated smartphone app. And all without a battery, the action of removing the injector cap powers the device. There is currently no injector pen on the market that combines these capabilities. Diabetes affects more than 371 million people worldwide and is expected to affect 552 million by 2030. While patients can live a very long and healthy life with diabetes, it is all dependent on good glycaemic control, which in turn depends on taking the required amount of insulin at the appropriate times throughout the day. If patients do not maintain their glucose levels within the target range, this can damage their organs, blood vessels and nerves over time, putting them at risk of further health complications which is driving the high cost of diabetes in the healthcare system. Current market offerings allow patients to know when the last insulin dose was given by freezing the time the cap was taken off the pen. This, however, leaves room for error if the cap falls off accidentally, providing false confirmation that the dose was taken. By being able to confirm the actual injection event and the exact dose of insulin delivered and deducing the time it was delivered via the smartphone, KiCoPen allows the patient to be confident they are on track with their daily insulin regimen. This in turn improves patient compliance and results in better glycaemic control, helping to reduce late-stage complications. Additionally, the KiCoPen concept uses energy harvesting from the motion of the cap removal and replacement to power the electronics, which are based on a single chip. Eliminating the battery gives greater design freedom to create a better user experience. It also means the injector can be more reliable, manufacturing and assembly effort is reduced, and the device can have a lower environmental footprint. "Our new injection pen design allows patients to easily self-manage their diabetes treatment, while ensuring they're getting the exact amount of insulin they need. It also proves to manufacturers that such an innovative, low-cost design can also be applied to pre-filled pens." said Ms Vaishali Kamat, head of digital health at Cambridge Consultants. Cambridge Consultants is also developing a companion app that can provide the patient with access to all the necessary data and relevant analytics - in one place - to manage their diabetes. ]]> <![CDATA[BMS, Novartis to evaluate combo cancer drug]]> https://biospectrumindia.com/news/95/3383/bms-novartis-to-evaluate-combo-cancer-drug.html https://biospectrumindia.com/news/95/3383/bms-novartis-to-evaluate-combo-cancer-drug.html Wed, 08 Oct 2014 09:22:59 +0530 Bristol-Myers Squibb (BMS) has announced the establishment of a clinical trial collaboration with Novartis. The collaboration aims to evaluate the safety, tolerability and preliminary efficacy of its investigational PD-1 immune checkpoint inhibitor Opdivo (nivolumab) with three molecularly targeted oncology therapies (Zykadia (ceritinib), INC280 and EGF816) from Novartis. Novartis will conduct two Phase 1/2 studies focused on non-small cell lung cancer (NSCLC). "Bristol-Myers Squibb is committed to advancing the science, research and development of immunotherapy as an innovative approach to treating cancer in multiple tumor types," said Mr Michael Giordano, senior vice president, Oncology Development, BMS. "Combining Opdivo with select targeted agents from Novartis complements our broad global development strategy of immuno-oncology combinations across the spectrum of lung cancer settings, and supports our goal of improving outcomes for patients", he added. Opdivo is part of a new class of cancer treatments known as immunotherapies designed to harness the body's own immune system in fighting cancer, and targets distinct regulatory components of the immune system. Zykadia, INC280 and EGF816 have each demonstrated evidence of targeting specific molecules responsible for tumor growth in NSCLC patient populations. The studies will explore the potential of enhanced anti-tumor response using a combined immunotherapy and targeted molecular approach. ]]> <![CDATA[Actavis to acquire Durata Therapeutics]]> https://biospectrumindia.com/news/95/4840/actavis-to-acquire-durata-therapeutics.html https://biospectrumindia.com/news/95/4840/actavis-to-acquire-durata-therapeutics.html Wed, 08 Oct 2014 09:19:47 +0530 Actavis to buy Durata Therapeutics and its antibiotic Dalvance in a deal worth $675 million. Dalvance for injection, an IV antibiotic for acute bacterial skin and skin structure infections, is one of Durata's key product. Actavis has offered $23 per share in cash, plus a contingent value rights element of up to $5 per share depending on how well Dalvance (dalbavancin) does. "The acquisition of Durata is a strong strategic fit that strengthens Actavis' emerging infectious disease franchise and aligns with our stated goal to make smart, targeted investments," said Actavis' chief executive Mr Brent Saunders. He added, "Dalvance complements the firm's antibiotic Teflaro (ceftaroline fosamil) and a ceftazidine-avibactam combination, currently in late-stage development, which are intended for use in the in-patient setting." The deal is expected to be completed by late 2014 or early 2015. ]]> <![CDATA[Anatara Lifesciences raises $7 million]]> https://biospectrumindia.com/news/95/4818/anatara-lifesciences-raises-7-million.html https://biospectrumindia.com/news/95/4818/anatara-lifesciences-raises-7-million.html Wed, 08 Oct 2014 09:18:48 +0530 Anatara Lifesciences was offered 14 million shares at $0.50 a share, and has successfully raised $7 million through an oversubscribed Initial Public Offering (IPO) that has now been closed. The company is focused on developing non-antibiotic medicines for the treatment and prevention of diarrhea in animals and humans. "The response by investors to the offering has been fantastic. We look forward to delivering on the enthusiasm and faith investors have shown in supporting the company and its planned future. The fact that the lead compound is derived from pineapple stems, a natural and safe resource, and addresses a significant area of unmet medical need, seems to have resonated with investors," said company's chairman and co-founder Dr Mel Bridges. Anatara's lead product, Detach is a non-antibiotic therapy to treat and prevent diarrhea. The company is focused on commercialising Detach initially for use in pigs, ahead of expanding its use to other livestock, and then developing it for use in humans. The IPO was led by Wilson HTM with co-manager Peloton Capital and legal advisers McCullough Robertson. ]]> <![CDATA[Cipla to invest Rs 225 cr for new facility in Iran]]> https://biospectrumindia.com/news/95/5438/cipla-to-invest-rs-225-cr-for-new-facility-in-iran.html https://biospectrumindia.com/news/95/5438/cipla-to-invest-rs-225-cr-for-new-facility-in-iran.html Tue, 07 Oct 2014 16:41:00 +0530 The Mumbai-based company will invest approximately Rs 225 crore in the next three years for a 75 percent stake, for all the machinery, equipment, and technical know-how. "The proposed investment is subject to completion of certain conditions precedent and applicable regulatory approvals," said Cipla in a statement to BSE. Earlier in September 2014, Cipla announced its plans to invest more in Kenya. In the same month, it ventured in to Czech and Slovakian markets as well. In June this year, the company signed another agreement to buy 51 percent stake in a pharmaceuticals manufacturing and distribution business in Yemen. Simultaneously, it also acquired Sri Lankan drug distributor for $14 million. In 2013, Cipla acquired its distribution partner Cipla Medpro South Africa for $512 million. ]]> <![CDATA[Industry protests against smear campaign ]]> https://biospectrumindia.com/news/95/5742/industry-protests-against-smear-campaign-.html https://biospectrumindia.com/news/95/5742/industry-protests-against-smear-campaign-.html Tue, 07 Oct 2014 14:54:15 +0530 As per IBEF, there are efforts to tarnish the image of the Indian pharma industry which it has painstakingly developed over the years and is often recognized as "Pharmacy of the World". AEI has published the findings of a "study" as a working paper in the National Bureau of Economic Research (NBER) Working Paper series. The study has not been reviewed by any of the authors' peers as is the gold standard in serious academic publishing. The study cites anecdotal evidence and hearsay, quoted earlier in the author's other publications, as facts with established academic provenance. "Cleverly, the Board of NBER distances itself from the contents of the report; yet parts are being reproduced under NBER's name to give it credibility which is completely being otherwise," mentions the statement from IBEF, representing Indian industry and government. The study claims to assess "the quality of 1,470 antibiotic and tuberculosis drug samples that claim to be made in India and were sold in Africa, India, and five mid-income non-African countries" based on samples "from pharmacies in 22 cities of 18 low-to mid-income countries between 2009 and 2012." The conclusions of the study are disputed not only for methodology and ethics but also for the poor treatment of data sampling used. "Quality is one of the major focus for pharmaceutical exports from India. Indian companies meet the quality requirements of all our importing countries. India looks at healthcare as a holistic issue rather than just commercial business," said Mr Sudhanshu Pandey, joint secretary, Department of Commerce, Government of India Commenting on the conclusions, Mr D G Shah, secretary general of Indian Pharmaceutical Alliance (IPA), an industry body of twenty research-based Indian pharmaceutical companies, "The study recognizes that products with "Made in India" label may not be actually made in India. The study also recognizes that transportation and storage conditions could have impacted the quality of products. But ignoring these realities, it still attributes poor quality (of drugs at the consumer end) to manufacturers and the Indian pharma regulator." This is not only strange but reflects a campaign with an ulterior motive rather than actually being concerned about quality issues. Faulting the study for its methodology, Mr Shah notes that "The samples were collected between 2009 and 2012. But the study does not clarify as to when and where the samples were tested and why did it take two years to write the Report." Pharmexcil India director general, Dr PV Appaji has protested the lack of ethics in the study. "There seems to be a deliberate campaign to malign the Indian pharma industry. The minimum requirement would be to give an opportunity to the labelled manufacturers to give their comments against their test observations." Without regards to ethics, data collection and sampling techniques or even the primary protocols involved in publishing such research, the authors have made several allegations passing off as statistical conclusions from the so-called study. It is not known whether they have selected the test sample on a rational basis, keeping in view the huge volumes of generics shipped from India or from a select few companies. It is surprising to note how they could identify the products as unregistered. If they are known to be unregistered, it is possible that small quantities might have entered market channels from local or other than Indian sources. In all fairness, when such results are found, they should have also contacted Pharmexcil or Indian drug regulators in advance and ascertained the facts. By disclosing the results of their test after about two years, they have forbidden the manufacturers even to test or retest their reference/control samples as maintained by them under Drugs and Cosmetics Act of India. Majority of them would have crossed 'date of expiry' as shown on the labels. In fact, Pharmexcil's Dr Appaji points out at least eight technical issues with the sampling and data techniques. Some of these are: Samples are not authenticated either from the source or from the regulators of the local country; samples were not referred to manufacturers to ascertain their genuineness; Minilab protocols are used to analyse the drugs, which is not taken as a conclusive analysis; the authors have not recorded or stated about the storage conditions at which samples were stored and collected; samples drawn from Africa are not registered in their country; Authors have not ascertained the source of supply of the drug and not indicated in the report. They directly pointed out that they are from India; the names of the manufacturing firms were not disclosed; the study fails to indicate the reference standards used. "On the above observations, the report has no value on the face but they have published this report to damage the image of India in the international market," Dr Appaji said. IPA's Mr Shah points out that the internal inconsistencies in the report which has been designed to "pass off pre-conceived notions and a hidden agenda in the garb of a scientific study." For instance, Mr Shah notes that "of the 1,470 samples tested, 91% "passed" for India (according to the template set out by the authors), 83.7 percent for Africa, and 95.2 percent for non-Africa (China, Brazil, Russia, Turkey, and Thailand). However, it tested only one product (Ciprofloxacin) for non-Africa to conclude that quality of product in non-Africa were better than for India." AEI is an independent, non-profit organization, supported primarily by grants and contributions from foundations, corporations, and individuals. According to the disclaimer clauses in the study, "The Legatum Institute funded the collection of medicines and testing and a grant from the Social Sciences and Humanities Research Council of Canada provided subsequent funding to cover analysis of drug samples." Realising the serious damage that such an irresponsible report is trying to make, the pharma industry has asked the Government of India to initiate legal proceedings against all concerned. ]]> <![CDATA[BRI, Jubilant to bring XylaMax to the South Asian market ]]> https://biospectrumindia.com/news/95/4292/bri-jubilant-to-bring-xylamax-to-the-south-asian-market-.html https://biospectrumindia.com/news/95/4292/bri-jubilant-to-bring-xylamax-to-the-south-asian-market-.html Tue, 07 Oct 2014 13:40:45 +0530 BioResource International Inc (BRI) has signed a marketing agreement with Jubilant Life Sciences for marketing and distribution of selected feed enzyme products in South Asia. Jubilant, recognized as the second largest manufacturer of Vitamin B3 (Niacin and Niacinamide) in the world and for its leadership in vitamins for the animal nutrition market, will be the exclusive marketing partner of BRI's Xylamax and XylaQuick products in South Asia. It will market and distribute the products to large volume poultry producers, feed integrators, and animal health and nutrition consultants throughout India, Pakistan, Sri Lanka, Nepal, Bangladesh, and Bhutan. "The addition of Jubilant Life Sciences to our alliance of global business partners marks the beginning of the next phase of our strategic growth plan," said Dr Giles Shih, CEO, BRI. "We look forward to a successful, long-term partnership with Jubilant and their customers in the South Asia market." BRI is a global biotechnology company specializing in the research, development and manufacture of high-performance, cost effective enzyme solutions for animal nutrition. Xylamax, BRI's newest product, is an intrinsically thermo-stable xylanase feed enzyme delivering consistent, all-around performance in both nutrient release and absorption. It has been scientifically proven to help producers optimize animal nutrition safely and sustainably. The unique XylaQuick (Xylamax Qualitative In-feed Colorimetric Kit) test allows for easy, on-site testing to confirm that Xylamax has been added and properly distributed within the animal feed. "Strategically, it is a very positive development for us. Jubilant is a significant player in the nutrition market and manufactures a wide range of Nutrition Ingredients for application across feed, food, pharmaceutical, agrochemical, technical, and personal care. We are already present in the animal nutrition segment through a range of feed additives. We are happy about our association with BRI as it will help us accelerate and expand our product portfolio into enzymes," said Mr Pramod Yadav, CEO, Advance Intermediates and Nutritional Products, Jubilant Life Sciences. "BRI, with its expertise in the design and development of safe, effective and economical enzyme solutions, made an appealing partner consistent with our corporate commitment to long-term sustainability through reduced environmental footprint," added Mr Yadav. According to the Investment Information and Credit Rating Agency of India (ICRA), Indian poultry sector has been growing at around 8-10 percent annually over the last decade with broiler meat volumes growing at more than 10 percent, while table egg which is growing at 5-6 percent is mainly driven by increased domestic consumption. "Partnering with Jubilant provides BRI an important strategic opportunity to showcase our newest enzyme solution, Xylamax, in the South Asia market," commented Mr Julian Young, chief operating officer, BRI. "This partnership brings together two like-minded companies, both committed to managing rising feed costs and feed ingredient quality variations in a way that is safe for animals, humans and the environment. ]]> <![CDATA[AdvaMed welcomes health minister's statement on NCDs]]> https://biospectrumindia.com/news/95/4291/advamed-welcomes-health-ministers-statement-on-ncds.html https://biospectrumindia.com/news/95/4291/advamed-welcomes-health-ministers-statement-on-ncds.html Tue, 07 Oct 2014 13:32:51 +0530 AdvaMed which represents Indian medical technology companies has said that it feels encouraged by the health minister, Dr Harsh Vardhan's September 29â€‹ announcement of a campaign involving all stakeholders, that will focus on tackling non-communicable diseases (NCDs) and on spreading awareness about the dangers of cardio-vascular diseases. "Given India's rising non-communicable disease burden, medical devices have a critical role to play in the diagnosis and management of complex diseases and in allowing people to live fuller, more productive lives. â€‹Forâ€‹ instance, the evolution of coronary stents has halved the number of people dying from heart attacks while implanted cardiac defibrillators have increased the chance of surviving a cardiac arrest," mentioned the statement by the leading industry body. â€‹ AdvaMed has also strongly backed the building of a transparent, value-driven healthcare system and is looking forward to play a larger role in supporting the health minister and the Indian government in addressing India's healthcare challenges. ]]> <![CDATA[With marketing approval for Trois, Venus makes an entry into Singapore]]> https://biospectrumindia.com/news/95/5062/with-marketing-approval-for-trois-venus-makes-an-entry-into-singapore.html https://biospectrumindia.com/news/95/5062/with-marketing-approval-for-trois-venus-makes-an-entry-into-singapore.html Tue, 07 Oct 2014 12:57:00 +0530 Venus Remedies is currently holding talks with various pharmaceutical firms for tie-ups to market its herbal nanotechnology-based pain reliever Troisin in Singapore. The company has entered Singapore's topical pain management market with a marketing authorisation and patent for the product. "This is a great opportunity for us to capture a sizeable share in this segment of the Singapore pharma market. Trois has a huge potential in Singapore, where 10 percent of the people are diagnosed with arthritis, 73.4 percent of the office workers suffer from musculoskeletal disorders and 20 percent of the population above the age of 65 suffers from symptoms of osteoarthritis," said hailing the achievement, Venus Remedies chairman and managing director, Mr Pawan Chaudhary. As per Mr Chaudhary, the topical pain management market is $4 billion globally, and, going by global projections, Trois has the potential of becoming a $250-million product once launched internationally. A product for topical use, the company claims Trois provides relief to patients suffering from rheumatic disorders, low back pain, osteoarthritis, rheumatoid arthritis, gout, knee pain, ankylosing spondylitis, fibromyalgia and pain originating from muscles and tendons. Currently, more than 1.5 billion people worldwide suffer from chronic pains of varying degree. "Trois is the safest known topical product for management of pain and inflammation associated with rheumatic disorders. It is 30 percent more effective than conventional products, as proven by a series of toxicity and safety studies. It has 150 percent enhanced retention for longer effect, improved relief and better mobility," said Dr Manu Chaudhary, joint managing director and director-research, Venus Remedies. A pioneer in translational medicine, Venus has filed the product, process and use patent for Trois in 46 countries. While the company has already received patents from South Africa, New Zealand and now Singapore, it is on the verge of getting patent grants from the US, Canada and Europe. ]]> <![CDATA[Nobel Prize in Physiology or Medicine 2014 announced]]> https://biospectrumindia.com/news/95/5281/nobel-prize-in-physiology-or-medicine-2014-announced.html https://biospectrumindia.com/news/95/5281/nobel-prize-in-physiology-or-medicine-2014-announced.html Mon, 06 Oct 2014 18:15:43 +0530 The prize was announced today by Prof GÃ¶ran K Hansson, Secretary, Nobel Committee for Physiology or Medicine. Below is the press release from the official website of Nobel Prize: How do we know where we are? How can we find the way from one place to another? And how can we store this information in such a way that we can immediately find the way the next time we trace the same path? This year's Nobel Laureates have discovered a positioning system, an "inner GPS" in the brain that makes it possible to orient ourselves in space, demonstrating a cellular basis for higher cognitive function. In 1971, John O´Keefe discovered the first component of this positioning system. He found that a type of nerve cell in an area of the brain called the hippocampus that was always activated when a rat was at a certain place in a room. Other nerve cells were activated when the rat was at other places. O´Keefe concluded that these "place cells" formed a map of the room. More than three decades later, in 2005, May-Britt and Edvard Moser discovered another key component of the brain's positioning system. They identified another type of nerve cell, which they called "grid cells", that generate a coordinate system and allow for precise positioning and pathfinding. Their subsequent research showed how place and grid cells make it possible to determine position and to navigate. The discoveries of John O´Keefe, May-Britt Moser and Edvard Moser have solved a problem that has occupied philosophers and scientists for centuries - how does the brain create a map of the space surrounding us and how can we navigate our way through a complex environment? How do we experience our environment? The sense of place and the ability to navigate are fundamental to our existence. The sense of place gives a perception of position in the environment. During navigation, it is interlinked with a sense of distance that is based on motion and knowledge of previous positions. Questions about place and navigation have engaged philosophers and scientists for a long time. More than 200 years ago, the German philosopher Immanuel Kant argued that some mental abilities exist as a priori knowledge, independent of experience. He considered the concept of space as an inbuilt principle of the mind, one through which the world is and must be perceived. With the advent of behavioral psychology in the mid-20th century, these questions could be addressed experimentally. When Edward Tolman examined rats moving through labyrinths, he found that they could learn how to navigate, and proposed that a "cognitive map" formed in the brain allowed them to find their way. But questions still lingered - how would such a map be represented in the brain? John O´Keefe and the place in space John O´Keefe was fascinated by the problem of how the brain controls behavior and decided, in the late 1960s, to attack this question with neurophysiological methods. When recording signals from individual nerve cells in a part of the brain called the hippocampus, in rats moving freely in a room, O'Keefe discovered that certain nerve cells were activated when the animal assumed a particular place in the environment. He could demonstrate that these "place cells" were not merely registering visual input, but were building up an inner map of the environment. O'Keefe concluded that the hippocampus generates numerous maps, represented by the collective activity of place cells that are activated in different environments. Therefore, the memory of an environment can be stored as a specific combination of place cell activities in the hippocampus. May-Britt and Edvard Moser find the coordinates May-Britt and Edvard Moser were mapping the connections to the hippocampus in rats moving in a room when they discovered an astonishing pattern of activity in a nearby part of the brain called the entorhinal cortex. Here, certain cells were activated when the rat passed multiple locations arranged in a hexagonal grid. Each of these cells was activated in a unique spatial pattern and collectively these "grid cells" constitute a coordinate system that allows for spatial navigation. Together with other cells of the entorhinal cortex that recognize the direction of the head and the border of the room, they form circuits with the place cells in the hippocampus. This circuitry constitutes a comprehensive positioning system, an inner GPS, in the brain. A place for maps in the human brain Recent investigations with brain imaging techniques, as well as studies of patients undergoing neurosurgery, have provided evidence that place and grid cells exist also in humans. In patients with Alzheimer´s disease, the hippocampus and entorhinal cortex are frequently affected at an early stage, and these individuals often lose their way and cannot recognize the environment. Knowledge about the brain´s positioning system may, therefore, help us understand the mechanism underpinning the devastating spatial memory loss that affects people with this disease. The discovery of the brain's positioning system represents a paradigm shift in our understanding of how ensembles of specialized cells work together to execute higher cognitive functions. It has opened new avenues for understanding other cognitive processes, such as memory, thinking and planning. ]]> <![CDATA[Sanofi sets up its first R&D hub in Asia]]> https://biospectrumindia.com/news/95/5641/sanofi-sets-up-its-first-rd-hub-in-asia.html https://biospectrumindia.com/news/95/5641/sanofi-sets-up-its-first-rd-hub-in-asia.html Mon, 06 Oct 2014 16:32:33 +0530 French drug maker Sanofi recently announced the opening of its first research hub in Asia in Shanghai, China. Sanofi's fifth big R&D hub aims to integrate work being done on biopharmaceuticals, rare diseases, vaccines, and animal health. The new research center will create 1,400 jobs integrating Sanofi's existing expertise in lifesciences from 12 countries in the region. Dr Jiang Ningjun, president of Sanofi's Asia R&D headquarters, said, "The new facility would allow the company to be more flexible and strengthen its regional links with external research partners." Sanofi also announced that it will be working with the GPCR Institute on new diabetes "breakthroughs" and also collaborate with ZAI Lab on respiratory ailments. Mr Frank Jiang, VP, head of the Asia-Pacific R&D hub, told Shangai Daily, "Asia Pacific is home to a wide spectrum of healthcare needs and we are excited to enhance our ability to capture opportunities and to respond to the changing market demands." Sanofi already has 50 collaborative projects in the Asia Pacific region and the company plans to take advantage of the lucrative Chinese market by introducing novel and innovative drugs. ]]> <![CDATA[Facebook ventures into healthcare]]> https://biospectrumindia.com/news/95/5628/facebook-ventures-into-healthcare.html https://biospectrumindia.com/news/95/5628/facebook-ventures-into-healthcare.html Mon, 06 Oct 2014 15:55:21 +0530 Reports suggest that Facebook is planning to take baby steps in the fertile field of healthcare, following on the heels of major techie groups like Google and Apple. According to media reports, the company is exploring the idea of creating online 'support communities' that could connect Facebook users suffering from various ailments. Facebook is considering the creation of new preventive care healthcare applications that can help people take proactive steps, which could help prevent ailments and improve health and lifestyle. In recent months, the social networking giant has held various meetings with medical industry experts and entrepreneurs, and is setting up a research and development unit to test new health apps. Facebook's research team said that people with chronic ailments such as diabetes and cardiovascular illness often surf the web for healthcare advice. However, Facebook has constantly suffered considerable criticism in its failure in maintaining the privacy of its users. This will be seen as a major challenge for the company during its venture into the healthcare sector. ]]> <![CDATA['Government not recognizing biopesticides']]> https://biospectrumindia.com/news/95/4051/government-not-recognizing-biopesticides.html https://biospectrumindia.com/news/95/4051/government-not-recognizing-biopesticides.html Mon, 06 Oct 2014 15:22:59 +0530 To adapt to these challenges of tomorrow, innovation plays a key role in helping farmers grow yields sustainably and conserve natural resources. Bangalore-based Camson BioTechnologies is aiming to fulfil this need by offering hybrid seeds, bio-fertilizers, and biocides that are non-poisonous, eco-friendly, and residue-free to the farming community. Mr Santosh Nair, the CEO of the company, in an exclusive interview shares his company's plans with BioSpectrum. Edited excerpts: Q: Why Camson is planning to demerge its seeds business in to a separate company?Mr Santosh Nair: This move will allow Camson to focus on its smaller but faster growing bio pesticide business. This would de-risk the business model, leading to a better valuation of the firm and would also be beneficial from a regulatory angle. We would be naming our seeds business as Camson Seeds and bio-pesticide business as Camson Biotechnologies. Q: Can you share the uniqueness of Camson Biotechnologies and Biocides?Although synthetic chemical pesticides are often effective in controlling pests, many are acutely toxic and are suspected carcinogens. Repeated use of synthetic fertilizers leads to soil infertility, eutrophication of water bodies and accumulation of toxic heavy metals in soil. Due to recent technological advances and increasing environment and safety concerns, biologically-derived products are becoming increasingly important components of Integrated Pest Management (IPM). Derived entirely from microbes, Camson has created a unique range of bio-pesticides called Biocides. These are distinguished from synthetic pesticides by their unique modes of action, low toxicity to non-target species, biodegradability and natural occurrence. Camson's Bio-fertilizers are also unique combinations of bio-agents that enhance the concentration of plant nutrients in the soil. Through biotechnology innovation, Camson's hybrid seed varieties offer maximum compatibility with organic and natural conditions and better yields. Camson's range of Natural Fertilizers are a breakthrough in Agri-biotech research. The products are subjected to rigorous testing and are certified by government agencies and academic authorities. Our products assure a balance of quality and unique attributes that make them the most favorable option for farmers. Q: How does biocides work?Microbial biopesticides and biofertilizers are formulates of secondary metabolites. These metabolites are bioagents beneficial to soil conditioning and improve the plant physiology and produce. They mobilize the micronutrients in the soil to maximize their utilization by the growing plant. Unlike broad-spectrum synthetic chemicals, these products work specifically against certain pests, without harming other organisms. Since they are living strains, they assimilate into the ecosystem without leaving any toxic residues. Q: How many farmers are using Camson's biocides? Over 6 lakh farmers are using our bio-pesticides currently. We are reaching out to farmers through our 8000-9000 touchpoints and distributors. The main challenge for us is that the government doesn't recognize bio-pesticides as an alternative for toxic rich urea or any other pesticides. India offers huge subsidies on toxic based fertilizers. Farmers find that as a cheaper alternative compared to ours. The Indian pesticides market is about Rs 8,000 crore and growing at the rate of 5-7 percent p.a. However, the awareness against the pesticides residue and the increase in export of fruits and vegetables from India has adversely affected the chemical pesticides business and its growth. Q: How is your seeds business doing? According to estimates, the global demand for food is likely to double by 2050 as world population multiplies and economic growth enables higher spending on food. Meeting the food demand of the world, across developed and developing nations is the biggest challenge governments and the private sector face in the near future. With lands shrinking and agricultural land resources diminishing, the only way to meet the food demand is by producing more from less and protecting the produce from destruction. We are addressing the food needs across the entire value chain. We are creating seeds for production of fruits, vegetables and more for the affordability-sensitive mass markets while our high-end non-seed tomato is aimed at the premium market segment. Q: Can you share some R&D efforts on this?Our seed R&D is focused on ensuring that consumers at the retail level get products which are healthy and 'user-friendly'. For example, our ice box watermelon an oblong and smaller watermelon, which is ideal for small families and storage in home refrigerators. And our yellow skin watermelon, another compact variety of the fleshy summer fruit have been very well received. We are shortly launching Black Chillies in the market. Through our investment in seed-based innovation, we have developed hybrid seed varieties that perform well under organic and natural conditions. This means that our seeds are tolerant to drought, pest attacks, and stress. Our unique seeds that have a long shelf life utilize natural conditions to provide higher yields and better margins to the farmer. Looking towards the future we will remain focused on innovation and operational excellence. In a major step towards building a more sustainable future for the company, we have stepped up our research investments to more than 20% of our revenue. We have also created a global supply chain function leading to an integrated supply unit, thereby creating the most efficient production models for our products. Q: What would be the revenue mix of your seeds business and biotech business currently and how it would change in the future?Currently seeds business is contributing around 70 percent of our revenues. Going forward we expect a ratio of 1:1, that is 50 per cent revenue from seeds and biotech business. Q: What are your growth plans?Our essential business opportunity is to convert farmers into using zero-residue Biocides and biofertilizers to ensure a safe produce. Based on a living organism, Biocides are distinguished by their unique modes of action, low toxicity, biodegradability and natural occurrence. Sustainable development through non-toxic methods which are safe is the core value and mission of our R&D development. We are in talks with institutional plantations firms like large coffee growers and tea plantations to use our biocides as an alternative to pesticides. We are also educating farmers along with farming consultants and pushing our product through retail front as well. ]]> <![CDATA[Sigma-Aldrich acquires Cell Marque to grow antibody portfolio]]> https://biospectrumindia.com/news/95/3337/sigma-aldrich-acquires-cell-marque-to-grow-antibody-portfolio.html https://biospectrumindia.com/news/95/3337/sigma-aldrich-acquires-cell-marque-to-grow-antibody-portfolio.html Mon, 06 Oct 2014 14:16:00 +0530 The terms of the transaction were not disclosed. Cell Marque, established in 1994, designs, develops and manufactures antibody reagents and kits, an offering that will complement Sigma-Aldrich's IHC product family. "We expect that Cell Marque's strong in vitro diagnostic (IVD) antibody product lines and solid relationships with pathologists and companies that provide automated staining instrumentation will broaden the diagnostic health reach of Sigma-Aldrich," commented Dr Frank Wicks, president, applied business unit, Sigma-Aldrich. The company expects this acquisition to be neutral to mildly accretive to earnings per share in 2015. The transaction, which is subject to regulatory approvals and other customary closing conditions, is anticipated to close by the end of 2014. Cell Marque is well-recognized in IHC for its high quality products and technical expertise, including validated, fit-for-purpose antibodies and IHC staining kits aimed at pathologists and clinicians focused on patient management. The company employs more than 90 people. Ms Nora Lacey, president and CEO, Cell Marque said, "..... being a member of the Sigma-Aldrich family will bring our customers a partner with the depth and breadth of resources to continually innovate and expand upon our product offering...." Interestingly Sigma-Aldrich was in turn acquired by Merck KGaA in September 2014 for $17 billion. ]]> <![CDATA[NIH donates $46 mn for BRAIN research]]> https://biospectrumindia.com/news/95/5140/nih-donates-46-mn-for-brain-research.html https://biospectrumindia.com/news/95/5140/nih-donates-46-mn-for-brain-research.html Mon, 06 Oct 2014 11:47:00 +0530 The National Institute of Health (NIH) has committed $46 million towards the White House's BRAIN Initiative, with aims to delve deeper into understanding the human mind. Scientists funded by the NIH BRAIN Initiative will develop tools to simultaneously watch the unique firing patterns of many neurons in hope of classifying them based on physical characteristics, such as size and shape, and functional characteristics, such as patterns of electrical activity. "There's a big gap between what we want to do in brain research and the technologies available to make exploration possible," said Mr Francis Collins, director, NIH in a statement. He added, "These initial awards are part of a 12 year scientific plan focused on developing the tools and technologies needed to make the next leap in understanding the brain." President Obama has given $110 million for the BRAIN initiative in 2014 and $200 million for the 2015 fiscal year. The government has revealed which researchers and universities will carry out the first federally funded projects under the initiative's banner, naming more than 100 investigators in 15 states and several countries. Researchers at the Princeton University, UC Berkeley, MIT, and Harvard are amongst the recipients of the funding. ]]> <![CDATA[Sanofi, Apollo to establish 'Sugar clinics']]> https://biospectrumindia.com/news/95/5144/sanofi-apollo-to-establish-sugar-clinics.html https://biospectrumindia.com/news/95/5144/sanofi-apollo-to-establish-sugar-clinics.html Sat, 04 Oct 2014 11:17:00 +0530 Healthcare major Apollo Hospitals and global pharma firm Sanofi have joined hands to provide diabetes care programs through the Apollo Sugar Clinics, in which Sanofi wants to buy a 20 percent stake. "The collaboration will eventually lead to a joint venture between the two companies aiming to offer patients integrated, advanced care, and counselling that will help them better manage their conditions," said Mr Prathap C Reddy, Apollo Hospitals' group founder, chairman in a statement. He added, "We have around 30 Apollo Sugar Clinics at present. By the end of October or mid-November, we will take the number to 50. Our target is to have over 200 by the end of 2016." "By joining together to expand the Apollo Sugar Clinics, we are demonstrating our commitment to delivering a superior patient experience that offers support at various stages of the diabetes care journey and aims to reduce the burden of diabetes," said Mr Christopher A Viehbacher, CEO, Sanofi. The companies have currently applied for government approvals for the structure and other specifics are still being worked out, executives from both companies said. ]]> <![CDATA[GVK Bio under the European regulatory scanner]]> https://biospectrumindia.com/news/95/5395/gvk-bio-under-the-european-regulatory-scanner.html https://biospectrumindia.com/news/95/5395/gvk-bio-under-the-european-regulatory-scanner.html Fri, 03 Oct 2014 12:12:00 +0530 The European Medicines Agency (EMA) has started a review in connection with findings of alleged non-compliance with good clinical practices (GCP) at a facility owned by GVK Biosciences, said reports. The regulatory body's action comes after French medicines agency (ANSM) raised concerns over study data used by GVK Bio to support the marketing authorization applications of generic medicines. "The review will cover nationally authorized medicines whose marketing authorization applications included clinical data from studies conducted by GVK Biosciences. The review of medicines for which studies have been conducted by GVK Bio has been initiated at the request of the European Commission, under Article 31 of Directive 2001/83/EC," said the European drug regulator in a statement. The company said that it has submitted necessary clarifications to the French authorities. "We are in the resolution stage and hope to close the matter to their satisfaction at the earliest. We are expecting the closure (of the matter) by October 26," said a company official. ]]> <![CDATA[Blood test to detect pancreatic cancer]]> https://biospectrumindia.com/news/95/5411/blood-test-to-detect-pancreatic-cancer.html https://biospectrumindia.com/news/95/5411/blood-test-to-detect-pancreatic-cancer.html Fri, 03 Oct 2014 11:38:00 +0530 Scientists at Dana-Farber Cancer Institute, the Massachusetts Institute of Technology, have discovered a sign of the early development of pancreatic cancer. According to them, extremely high levels of amino acids in the bloodstream are linked to an increased risk of pancreatic cancer. This discovery would pave the way for an early detection of panc. "Most people with pancreatic ductal adenocarcinoma (PDAC) [by far the most common form of cancreatic cancer are diagnosed after the disease has reached an advanced stage, and many die within a year of diagnosis," said Mr Brian Wolpin, co-author of the study. He said, "Detecting the disease earlier in its development may improve our ability to treat it successfully. In this study, we asked whether PDAC produces metabolic changes that can be detected before the disease is diagnosed." The finding came from the analysis of blood samples from 1,500 people taking part in large health tracking studies. "We found that higher levels of branched chain amino acids were present in people who went on to develop pancreatic cancer, compared to those who did not develop the disease. These findings led us to hypothesize that the increase in branched chain amino acids is due to the presence of an early pancreatic tumor," said Dr Wolpin. ]]> <![CDATA[MedImmune, CRT join hands to develop cancer medicine]]> https://biospectrumindia.com/news/95/4986/medimmune-crt-join-hands-to-develop-cancer-medicine.html https://biospectrumindia.com/news/95/4986/medimmune-crt-join-hands-to-develop-cancer-medicine.html Thu, 02 Oct 2014 12:12:00 +0530 MedImmune, AstraZeneca's global biologics research and development arm and Cancer Research with its commercial arm, Cancer Research Technology (CRT), have entered into an innovative collaboration to establish a joint laboratory in Cambridge. The new laboratory will focus on the discovery and development of novel biologic cancer treatments over an initial five-year period. As part of the collaboration, scientists from both the organizations will work side-by-side on multiple oncology projects at the new CRUK-MEDI Alliance Laboratory. Cancer Research will provide the set-up and operational funding for the laboratory and will contribute a portfolio of novel drug targets together with a team of scientists. MedImmune will oversee the laboratory activities and provide access to its human antibody phage display libraries and established antibody-engineering technologies. The joint team will share knowledge and expertise to discover and develop antibodies to treat cancer. "Oncology is a core therapeutic area for AstraZeneca and we are pleased to enter this strategic antibody discovery and development collaboration with Cancer Research UK, one of the leading charitable cancer research institutions in the world. Our collaboration represents an innovative public-private business model for biologic drug development as we will share knowledge and expertise in a dedicated laboratory to discover potentially ground-breaking medicines for cancer patients," said Dr Bahija Jallal, executive vice president, MedImmune. Mr Keith Blundy, chief executive officer, CRT said, "MedImmune is one of Cancer Research UK's important strategic partners as we seek to advance biologic treatments for cancer. This unique partnership will bring together cutting-edge research with the most advanced antibody technologies industry can offer under one roof, to deliver significant output over a number of years. Cancer Research UK-funded scientists from across the UK will have the opportunity to access this unique lab and expertise. It's the first of what we hope will be many such pioneering collaborations that will help to accelerate the translation of our research into potential new drugs." ]]> <![CDATA[J&J buys Alios Biopharma in a $1.75 bn all cash deal]]> https://biospectrumindia.com/news/95/4988/jj-buys-alios-biopharma-in-a-1-75-bn-all-cash-deal.html https://biospectrumindia.com/news/95/4988/jj-buys-alios-biopharma-in-a-1-75-bn-all-cash-deal.html Thu, 02 Oct 2014 11:30:00 +0530 The privately-held biopharmaceutical company is focused on developing medicines to fight viral diseases. The acquisition will include Alios' portfolio of potential therapeutics for viral infections including AL-8176, an orally administered antiviral therapy currently in Phase II for the treatment of infants with respiratory syncytial virus (RSV). Mr William Hait, global head of R&D at J&J's Janssen unit, said, "We are excited that this acquisition will enable us to explore treatment options for a number of viral infections, including RSV, the last of the major pediatric diseases with no available preventive therapy." He added,"AL-8176 complements our existing early stage portfolio for RSV which aims to prevent and treat this disease, the leading cause of acute lower respiratory infection in children under the age of five." The transaction is expected to close in the fourth quarter this year. ]]> <![CDATA[Canada bans three Indian API manufacturers]]> https://biospectrumindia.com/news/95/5277/canada-bans-three-indian-api-manufacturers.html https://biospectrumindia.com/news/95/5277/canada-bans-three-indian-api-manufacturers.html Thu, 02 Oct 2014 11:09:00 +0530 Health Canada, national health agency, has banned the import of health products from three different companies in India including Apotex Pharmachem India Private Limited (APIPL), Apotex Research Private Limited (ARPL) and IPCA Laboratories after USFDA spotted data integrity issues at their sites. Health Canada has raised its concern on the manner in which data are collected and reported, raising serious doubts about the quality and safety of finished products and APIs produced at these sites. The agency has not recalled any of the products but has stopped imports as a temporary precautionary measure until it is satisfied of the processes followed at these sites. According to Health Canada, the action would apply to finished products from Apotex and active pharmaceutical ingredients (APIs) and products made with APIs from APIPL and IPCA. Health Canada has clarified that certain medically necessary products may be excluded from the action on the condition that they are tested by an independent third party before being released for use or sale. ]]> <![CDATA['Deadly diarrhea rates doubled in 10 years']]> https://biospectrumindia.com/news/95/5399/deadly-diarrhea-rates-doubled-in-10-years.html https://biospectrumindia.com/news/95/5399/deadly-diarrhea-rates-doubled-in-10-years.html Wed, 01 Oct 2014 17:25:38 +0530 According to a study published in the American Journal of Infection Control infections with the intestinal superbug C difficile (CDI) nearly doubled in ten years in US hospitals without noticeable improvement in patient mortality rates or hospital lengths of stay. C. difficile is the most common bacteria responsible for causing healthcare-associated infections in US hospitals and is linked to 14,000 deaths each year, as per the Centers for Disease Control and Preventio(CDC). In this study from the University of Texas College of Pharmacy, researchers analysed ten years of data from the US National Hospital Discharge Surveys (NHDS). From 2001 to 2010, rates of CDI among hospitalised adults rose from 4.5 to 8.2 CDI discharges per 1,000 total adult hospital discharges. "Our study found that peak CDI incidence occurred in 2008, with a slight decline through 2010. The leveling off of CDI incidence toward the end of our study period may be the result of increased antibiotic stewardship programs and improved infection control measures such as use of contact precautions, cleaning & disinfection of equipment, and environment & hand hygiene," said Dr Kelly Reveles, lead author of the study. The researchers found out that most CDI patients were female (59 percent) and more than 65 years of age (70 percent). Of the 2.2 million adult CDI discharges, 33 percent had a principal diagnosis of CDI; 67 percent were classified as secondary CDI, meaning that CDI was not the primary reason they were hospitalised. Approximately 7.1 percent, or 154,184 patients, died during the study period. ]]> <![CDATA[Apotex claims drugs manufactured at Bangalore facility safe]]> https://biospectrumindia.com/news/95/3981/apotex-claims-drugs-manufactured-at-bangalore-facility-safe.html https://biospectrumindia.com/news/95/3981/apotex-claims-drugs-manufactured-at-bangalore-facility-safe.html Wed, 01 Oct 2014 15:57:00 +0530 When raw materials or finished products are imported into Canada, they undergo a re-testing process at a Canadian facility before being distributed. "This secondary testing is not an option, but a legal mandate for all pharmaceutical companies shipping products and materials into Canada that provides an added level of precaution before the product reaches pharmacy shelves. This allows Health Canada to remain confident in the safety and effectiveness of imported products, and subsequently avoid any significant disruption in supply for patients," stated Dr Jeremy Desai, president and CEO, Apotex. The company in a press release claims that it goes above and beyond the requirement and retests every lot of finished product supplied to the Canadian market. Earlier in a statement, Health Canada said, "The quarantine will allow the department time to verify that products from this (Bangalore) facility meet Canadian safety and quality requirements." ]]> <![CDATA[Merck's Keytruda proves promising against gastric cancer]]> https://biospectrumindia.com/news/95/4944/mercks-keytruda-proves-promising-against-gastric-cancer.html https://biospectrumindia.com/news/95/4944/mercks-keytruda-proves-promising-against-gastric-cancer.html Wed, 01 Oct 2014 10:14:00 +0530 Merck's Keytruda has shown positive results in phase I studies against gastric cancer. The drug was earlier approved for the treatment of advanced melanoma. "Merck is advancing the development of Keytruda across different tumor types and lines of therapy. We are encouraged by the signals of anti-tumor activity in advanced gastric cancer, and are eager to move ahead with the Phase II study to better understand the potential of KEYTRUDA in advanced gastric cancer," said Dr Alise Reicin, vice president, Oncology, Merck Research Laboratories. In the study involving 39 patients with PD-L1 positive, advanced gastric cancer, treatment with Keytruda led to significant tumor shrinkage in 12 patients or 31 percent of them. Based on this data, Merck said that it would initiate a pivotal Phase II study in the first quarter of 2015 to further explore the use of Keytruda in advanced gastric cancer. ]]> <![CDATA[Merck Serono launches Capacity Advancement Program in Maharashtra]]> https://biospectrumindia.com/news/95/5491/merck-serono-launches-capacity-advancement-program-in-maharashtra.html https://biospectrumindia.com/news/95/5491/merck-serono-launches-capacity-advancement-program-in-maharashtra.html Tue, 30 Sep 2014 16:38:43 +0530 The Merck Capacity Advancement Program (CAP) seeks to improve the healthcare sector in India with special focus on rural areas through educating and empowering those affected by diabetes on how to manage and prevent it. In addition to medical education and community awareness, Merck shall continue to work with partners in India at large to expand the capacity of professionals in diabetes management through its Capacity Advancement Program. Merck launched its Capacity Advancement Program (CAP) in India in collaboration with the Maharashtra University of Health Sciences and Directorate of Medical Education and Research, Mumbai. The program is a part of Merck's long term commitment to provide sustainable access to high-quality health solutions and safe medicines in India and the rest of Asia. The 5-year program kicked-off in 7 Sub-Saharan countries including Kenya, Uganda, Namibia Angola, Ghana, Tanzania, and Mozambique and will further expand to other Sub-Saharan and Asian countries in 2014. As part of the Merck CAP, more than 1,000 medical students from the Maharashtra University of Health sciences will benefit from European-accredited clinical diabetes and chronic diseases management training, which is seeking to equip them with skills to avert the diabetes epidemic. ]]> <![CDATA[Strides to acquire Shasun for $200 million]]> https://biospectrumindia.com/news/95/8379/strides-to-acquire-shasun-for-200-million.html https://biospectrumindia.com/news/95/8379/strides-to-acquire-shasun-for-200-million.html Tue, 30 Sep 2014 16:28:28 +0530 The resulting merger will generate revenues close to $406 million and will have a product pipeline of more than 100 drugs. Shasun shareholders is expected to own about 26 percent in the combined entity. Under the terms, for every 16 shares held by shareholders in Shasun, they will get five Strides Arcolab shares. Shasun has a strong portfolio of Active Pharmaceutical Ingredients (API). It is also noteworthy that last year Strides sold its injectable drugs business to US-based Mylan for $1.6 billion. The combined entity will have 12 manufacturing facilities, out of which 6 of the facilities will cater to emerging markets. The other six will include 3 USFDA approved finished dosage manufacturing facilities, 2 USFDA approved API manufacturing facilities, and 1 USFDA approved CRAMS facility. The new entity will be in the top 15 listed Indian pharma companies. Commenting on the merger, Mr Arun Kumar, founder and group CEO, Strides Arcolab stated, "....Strides has refocused on its oral finished formulation business. Today's proposed combination with Shasun accelerates our strategy and growth prospects by creating a larger scale, fully integrated, leading Indian pharma company with multiple growth drivers and synergies that will allow for enhanced profitability and more efficient use of our combined infrastructure and enhanced value creation opportunities for the combined shareholder group." Strides on September 29, 2014, announced its agreement with GMS Holdings whereby GMS will invest $21.9 million for a 25.1 percent stake in Stelis Biopharma, the biotech arm of Strides, to fund its Greenfield project. Till date, Strides has invested $16.9 million in Stelis. This month Strides also received its license from Gilead Sciences to produce generic sofosbuvir and investigational single tablet regimen of ledipasvir/sofosbuvir for treatment of chronic Hepatitis C. Mr Abhaya Kumar, CEO and MD, Shasun stated, "...Strides and Shasun bring complementary strengths and shared values of developing products and market opportunities across geographies and the combination accelerates both scale and scope. We are confident that the vertically integrated new combination will deliver further additional value in the near term for all stakeholders above and beyond the strong gains we have achieved to date on our own." ]]> <![CDATA[Pfizer's Xalkori effective against rare lung cancer]]> https://biospectrumindia.com/news/95/4882/pfizers-xalkori-effective-against-rare-lung-cancer.html https://biospectrumindia.com/news/95/4882/pfizers-xalkori-effective-against-rare-lung-cancer.html Tue, 30 Sep 2014 16:25:18 +0530 Pfizer's lung cancer drug Xalkori has shown positive results in reducing the size of tumors in lung cancer patients with a rare genetic mutation, an abnormality in the ROS1 gene. Xalkori was approved to treat patients with a mutation of the ALK gene, along with a companion diagnostic test to identify those with the mutation, which accounts for about 4 percent of non-small cell lung cancers (NSCLC). About 1 to 2 percent of NSCLC patients are believed to be ROS1 positive. According to the data presented at the European Society for Medical Oncology meeting, in the study of 50 non-small cell lung cancer patients with a rearrangement of the ROS1 gene, Xalkori treatment led to significant tumor shrinkage in 36 of them, or 72 percent, and halted tumor growth in 9 additional patients. "This is the first definitive study to establish crizotinib's activity in a large group of patients with ROS1-positive lung cancer and confirms that ROS1 is a bona fide therapeutic target in those patients. The remissions induced by crizotinib in ROS1-positive patients are quite prolonged, and (treatment) resistance appears to emerge much later, on average, than what we have seen with other targeted therapies for lung cancer and melanoma," said Dr Alice Shaw, the study's lead investigator from the Massachusetts General Hospital Cancer Center, in a statement. The study is published in the New England Journal of Medicine. ]]> <![CDATA[Apotex's drugs manufactured in Bangalore to be quarantined]]> https://biospectrumindia.com/news/95/4816/apotexs-drugs-manufactured-in-bangalore-to-be-quarantined.html https://biospectrumindia.com/news/95/4816/apotexs-drugs-manufactured-in-bangalore-to-be-quarantined.html Mon, 29 Sep 2014 17:26:20 +0530 In a statement Health Canada said, "The quarantine will allow the department time to verify that products from this facility meet Canadian safety and quality requirements." So far, the suspected drugs have not been pin-pointed by Health Canada. ]]> <![CDATA[Preventing pandemics in South Asia]]> https://biospectrumindia.com/news/95/4767/preventing-pandemics-in-south-asia.html https://biospectrumindia.com/news/95/4767/preventing-pandemics-in-south-asia.html Sun, 28 Sep 2014 11:17:00 +0530 New Zealand's Massey University has successfully completed a four year campaign involving healthcare professionals across major South Asian countries, to prevent the occurrence of pandemics in the region. The $10 million One Health program, was conducted in Sri Lanka, India, Pakistan, Nepal, Bangladesh, Afghanistan and Bhutan. Funded by the World Bank, the University has educated and connected veterinary and human health professionals in these countries, to increase the aware of zoonoses and to prevent its spread and transmission. The study involved testing of around 8000 humans and animals by 2000 health professionals from 50 government and non-government organizations. The priority-diseases investigated were rabies (in India, Bangladesh, Bhutan and Sri Lanka), brucellosis (Afghanistan, Pakistan, India, Sri Lanka), leptospirosis (Nepal, Sri Lanka), Qfever (Afghanistan), anthrax (Bangladesh) and Crimean Congo Haemorrhagic Fever (Pakistan). Dr Peter Jolly, One Health South Asia project manager, said, "The findings will be useful in formulating policies to aid the various governments in decisions making to prevent pandemics across the globe." Stating that the current Ebola epidemic has rung alarm bells for global disease prevention and forecasting epidemics, Dr Jolly said that the project was a significant contribution in battling against emerging diseases. The program involved two phases-the first phase involved delivering two degrees-a Master of Public Health (Biosecurity) and Master of Veterinary Medicine (Biosecurity) - to 68 veterinary and public health professionals. The second phase saw the development of One Health Hubs and collaborative disease investigation projects in each of the countries and launching of an online communication and collaboration network called Hubnet (www.hubnet.asia) that will be used in the future to monitor outbreaks of disease and share information about managing them. ]]> <![CDATA[Detect drug resistant TB in a jiffy]]> https://biospectrumindia.com/news/95/4587/detect-drug-resistant-tb-in-a-jiffy.html https://biospectrumindia.com/news/95/4587/detect-drug-resistant-tb-in-a-jiffy.html Sat, 27 Sep 2014 11:16:00 +0530 Soon, a simple breath test will detect whether a person is infected with a drug resistant tuberculosis strain or the normal strain. Scientists at the University of New Mexico, Albuquerque, have developed a new technique that can fast track the detection of drug resistant variants of the TB bacteria. The conventional sputum lab testing for TB bacteria can take up to six weeks, hence global scientists have begun the hunt for a faster diagnostic test that can help in early detection and better administration of treatment. The technique will detect traces of nitrogen gas emitted by the disease-causing germ Mycobacterium tuberculosis. Strains of the microbe which respond to the drug isoniazid have an enzyme called KatG that reacts to the antibiotic by releasing nitrogen which can then be detected using a mass spectrometer. A sample of breath is tested with isoniazid and if nitrogen gas is released, it indicates that the person has a TB infection that can be safely tackled with isoniazid, one of two frontline tuberculosis treatments. The new technique has shown promise in animal testing. Following human trials, the test could be used as a rapid diagnostic test to detect drug resistant TB bacteria. Researchers said that if the result is negative, it means that either a person does not have TB or has an isoniazid-resistant strain. The study was published in the journal Nature Communications. TB had claimed 1.3 million lives worldwide last year, making it the deadliest disease after AIDS to be caused by a single infectious agent, the UN's World Health Organisation WHO reported in July, 2014. ]]> <![CDATA[Pharmexcil announces outstanding exports awards]]> https://biospectrumindia.com/news/95/4806/pharmexcil-announces-outstanding-exports-awards.html https://biospectrumindia.com/news/95/4806/pharmexcil-announces-outstanding-exports-awards.html Sat, 27 Sep 2014 10:40:00 +0530 Indian Pharmexcil recently announced awards for outstanding export performances in the bulk drugs and formulations category, for the year 2013-14. Of the 150 applications, Lupin, Aurobindo and Mylan bagged top awards for their exceptional performance. Mumbai- based Lupin received the 'all-round performer' award, while Aurobindo Pharma and Mylan Laboratories have been judged as leading bulk drugs and formulations exporters respectively. The award for mid-range emerging companies were given to Laurus Labs and Glenmark Pharmaceuticals. Apotex research and Sanofi India were recognized as mid-range formulations doing excellent export business. Fourrts (India) Laboratories has bagged an award under emerging company category. The award for leading exporters of biopharmaceuticals was received by Hyderabad-based Biological E. Further Suven Life Sciences received an award as the leading contract research and manufacturer for the year 2013-14. Sami Labs and ACG- Associated Capsules have bagged outstanding export awards under herbals and excepients categories, while Omni Active Health Technologies, has bagged an award under the Nutraceuticals category. At the distribution ceremony, Dr P V Appaji, director general, Pharmexcil, said, "These awards are a token of encouragement to the pharma companies that are doing excellent business. I am confident that India will achieve the target of 17 billion dollars of pharma exports by the end of 2015." ]]> <![CDATA['APAC Non-Hodgkin Lymphoma treatment market to touch $1.7 bn']]> https://biospectrumindia.com/views/95/4582/apac-non-hodgkin-lymphoma-treatment-market-to-touch-1-7-bn.html https://biospectrumindia.com/views/95/4582/apac-non-hodgkin-lymphoma-treatment-market-to-touch-1-7-bn.html Sat, 27 Sep 2014 10:13:00 +0530 Non-Hodgkin Lymphoma (NHL) treatment market in Asia-Pacific (APAC) countries including India, Australia, China and Japan will expand from $1.1 billion in 2013 to $1.7 billion by 2020, according to business intelligence provider GBI Research. According to company's latest report, Japan had a 67.2 percent share of the APAC region's NHL therapeutics market in 2013. While this will dip slightly to 64.7 percent, the country's NHL market by value will reach approximately $1.1 billion by 2020. Ms Sravanthi Addapally, analyst, GBI Research, said, "Japan's expected growth will be largely attributable to a rapidly aging population and increased NHL incident cases, as well as the launch of new targeted therapies to treat previously underserved patient segments with numerous unmet needs. "Among the expected launches, ibrutinib for indolent NHL and everolimus for Diffuse Large B-Cell Lymphoma will increase the overall treatment costs and drive growth. The anticipated launches of monoclonal antibodies, such as Roche's obinutuzumab, will also significantly boost the market." The analyst adds that the approval of additional indications for Adcetris and the launch of the Imunomax-Î³, which is currently awaiting approval in Japan for mycosis fungoides/Sezary syndrome, will have a further positive impact. ]]> <![CDATA[Modi government likely to allow Bt brinjal, other GM crops soon]]> https://biospectrumindia.com/news/95/5531/modi-government-likely-to-allow-bt-brinjal-other-gm-crops-soon.html https://biospectrumindia.com/news/95/5531/modi-government-likely-to-allow-bt-brinjal-other-gm-crops-soon.html Fri, 26 Sep 2014 17:46:00 +0530 Just two months after overturning a regulatory approval to conduct field trials of 15 genetically-modified (GM) crops, the Narendra Modi government appears to have made a Uturn. In fact now the government wants to woo both foreign and Indian investors to make heavy investments to produce GM seeds within the country.The change in the government policy has been noticed during the "Make in India" program launched by the government on September 25, 2014. The "Make in India" campaign and website (www.makeinindia.com), which were launched by Prime Minister Narendra Modi on Thursday just before leaving for USA, calls for investments in Hybrid seeds, including GM seeds. Biotechnology is one of the 25 important sectors that have been identified as focus areas under the "Make in India" campaign. The section under investment opportunities lists "Hybrid Seeds, including GM Seeds, represents new business opportunities in India based on yield improvement". This is good news for the agri sector considering the fact that there has been a major stalemate on the issue of GM seeds, especially in the area of food crops. In fact, in a clear signal about a government rethink about the banned Bt brinjal, the official website says, "India has the potential to become a major producer of transgenic rice and several genetically modified or engineered vegetables." It appears that the National Democratic Alliance government is junking the leading party BJP's election manifesto which had favored a "cautious approach" to the introduction of GM crops in the country. GM seeds, GM rice and GM vegetables are touted as attractive areas for foreign and Indian investors to "make in India." It may be recalled that the current government decided to put on hold the regulatory approval taken by the Genetic Engineering Approval Committee (GEAC) on July 18, 2014, where 15 approvals for confined trials were granted. Out the 15 approvals by GEAC, four were for food crops -- mustard, brinjal, rice and chickpea. It also permitted the import of GM soybean oil by three MNCs -- Monsanto, Bayer BioScience and BASF. Organizations like the Swadesi Jagaran Manch (SJM) and Bharatiya Kisan Sangh (BKS), which are known to be close to the BJP, have been against cultivation of new genetically modified (GM) crops in the country and have been calling for a ban. Meanwhile, farmer leaders from 10 states in August urged union environment minister, Mr Prakash Javadekar, to expedite the field trials of GM crops to ensure farmers prosperity. Farmers from National Farmers Empowerment Initiative (NFEI), an umbrella body of various farmer organizations from across the country, also submitted a signed petition to Mr Javadekar. "Allow us to take this opportunity to congratulate you for making a bold statement that 'Science cannot be stopped' and clearly showcasing the need to allow scientific trials of GM crops. This has rekindled Indian farmers' hopes of receiving new technologies in our fields," the petition said. Punjab farmer leader Mr PPS Pangli, president of NFEI said, "We fear that a moratorium on research into biotechnology will ultimately have a ruinous effect on us farmers, as we will be denied crucial technology that will enable us to better our lives." Now just hours after the website was unveiled, Vijnana Bharati, a non-governmental organization of India, in an open letter appealed to the Prime Minister not to invite any sort of investments in the field of genetic engineering technologies to produce seeds in India. ]]> <![CDATA[US FDA fast tracks MedImmune's Pneumonia drug]]> https://biospectrumindia.com/news/95/4585/us-fda-fast-tracks-medimmunes-pneumonia-drug.html https://biospectrumindia.com/news/95/4585/us-fda-fast-tracks-medimmunes-pneumonia-drug.html Fri, 26 Sep 2014 14:57:33 +0530 MedImmune, AstraZeneca's global biologics research and development arm, has received a fast track designation from the US Food and Drug Administration (US FDA) for its investigational monoclonal antibody (mAb) MEDI3902 for the prevention of nosocomial pneumonia. The disease is caused by Pseudomonas aeruginosa (P. aeruginosa), a highly drug-resistant bacterial pathogen that causes serious illness in hospitalised patients. MEDI3902, currently entering Phase I clinical trials, is a novel mAb engineered to combine three distinct mechanisms of action for disarming and clearing P. aeruginosa. In pre-clinical trials, MEDI3902 was found to produce enhanced effects for both prevention and treatment of the problematic bacterial infection in multiple animal models. Prophylactic use of MEDI3902 will be investigated as a potentially new therapeutic approach for controlling pneumonia in hospitalized patients. "We are pleased that the FDA has granted Fast Track designation for MEDI3902, recognising the unique science behind this investigational monoclonal antibody and the importance of accelerating development of new medicines that may help prevent serious bacterial infections, such as nosocomial pneumonia, rather than solely relying on antibiotics to treat them," said Mr Steve Projan, senior vice president, R&D and Infectious Diseases and vaccines iMED head, MedImmune. He added, "At a time when antimicrobial resistance poses an imminent and urgent global public health threat, it's more important than ever to develop new therapies that both prevent and treat hospital acquired infections. The Fast Track designation will streamline communications with the FDA throughout the development process on what is a very different approach to the bacterial resistance problem. If successful, we hope to bring this important new medicine to patients as quickly as possible." MedImmune is exploring ways of using biologics to help prevent and treat challenging infectious diseases, including P. aeruginosa. ]]> <![CDATA[Thermofisher, GSK & Pfizer join hands to develop oncology diagnostics]]> https://biospectrumindia.com/news/95/4569/thermofisher-gsk-pfizer-join-hands-to-develop-oncology-diagnostics.html https://biospectrumindia.com/news/95/4569/thermofisher-gsk-pfizer-join-hands-to-develop-oncology-diagnostics.html Fri, 26 Sep 2014 14:54:26 +0530 Thermo Fisher Scientific and pharmaceutical companies, GlaxoSmithKline (GSK) and Pfizer have entered into an agreement to develop a universal next-generation sequencing (NGS) oncology test for solid tumors that will serve as a companion diagnostic for multiple drug programs. The test will be developed using Thermo Fisher Scientific's Ion Personal Genome Machine (PGM) Dx Platform, Ion AmpliSeq technology, and content from the Oncomine Cancer Research Panel. Companion diagnostics refer to tests that help identify those patients who are most suitable for treatment with targeted therapies. Using the Ion PGM Sequencing Platform combined with Ion AmpliSeq technology, hundreds of genes can be simultaneously analyzed from tumor samples via next-generation sequencing, with high reproducibility and rapid turnaround time. "To realize the promise of personalized medicine in oncology, cancer patients increasingly require multiple, complex genetic tests. Together with Pfizer, GSK, and potentially other pharmaceutical companies, we seek to change the paradigm and develop a single next-generation sequencing test that can provide a comprehensive analysis of multiple, relevant genetic markers," said Mr Dan Rhodes, head of Oncology for lifescience solutions at Thermo Fisher Scientific. He added, "This approach will help ensure that cancer patients have an opportunity to potentially benefit from a targeted therapy associated with their tumor's genetic profile." The development of this new universal companion diagnostic test will include markers from the Oncomine Cancer Research panel, which enables simultaneous testing of single nucleotide variants (SNVs), copy number variants (CNVs), gene fusions, and indels across 143 unique cancer genes. "The NGS-based approach will help accelerate the development of these promising new therapies and will ultimately help physicians identify clinical trials that help provide their patients with the best possibility of a successful outcome. An important additional benefit of using a multi-marker approach that interrogates many genetic markers simultaneously is that it can also help eliminate the need to develop a unique companion diagnostic test for each new therapy," said Mr Rhodes. "This collaboration with Pfizer and GSK enables us to build upon our market leading position in NGS oncology, with hundreds of customers around the world sequencing tens of thousands of tumor samples each month using Ion Torrent technology," said Mr Mark Stevenson, president of lifesciences solutions at Thermo Fisher Scientific. ]]> <![CDATA[Pfizer completes acquisition of InnoPharma]]> https://biospectrumindia.com/news/95/4631/pfizer-completes-acquisition-of-innopharma.html https://biospectrumindia.com/news/95/4631/pfizer-completes-acquisition-of-innopharma.html Fri, 26 Sep 2014 13:31:00 +0530 Pfizer has announced that it has completed the acquisition of the pharmaceutical development company, InnoPharma. The company has received regulatory approval from all US government authorities required by the agreement and other closing conditions. "We believe this acquisition will help Pfizer build a strong sterile injectables pipeline in areas such as oncology and central nervous disorders. Sterile injectables is one of the several areas of potential growth. This acquisition reflects our continued view that attractive growth opportunities, both external and organic, exist for the business," said Mr John Young, group president, Pfizer Global Established Pharma (GEP). ]]> <![CDATA[GSK appoints new chairman]]> https://biospectrumindia.com/news/95/4580/gsk-appoints-new-chairman.html https://biospectrumindia.com/news/95/4580/gsk-appoints-new-chairman.html Fri, 26 Sep 2014 13:29:00 +0530 Drugmaker GlaxoSmithKline (GSK) will name Sir Philip Hampton as its next chairman, according to reports. He currently chairs the Royal Bank of Scotland (RBS). Sir Philip will take up the post at the pharmaceutical company in September next year. In a statement, he said, "It has been a privilege to serve as the chairman of RBS since 2009. I am looking forward to working with my colleagues in the months ahead as we work to implement the bank's strategy and continue to improve the support we provide to our customers." Before RBS, Sir Philip had been the finance director at Lloyds TSB, BT, British Gas and British Steel. ]]> <![CDATA[Glenmark conferred the "Civic Award 2014"]]> https://biospectrumindia.com/news/95/3988/glenmark-conferred-the-civic-award-2014.html https://biospectrumindia.com/news/95/3988/glenmark-conferred-the-civic-award-2014.html Fri, 26 Sep 2014 11:29:12 +0530 Glenmark Pharmaceuticals has been awarded the Civic Award 2014 for Social Development by the Bombay Chamber of Commerce and Industry. The award was presented to the company for its exemplary initiatives in the area of Corporate Social Responsibility (CSR) through which the company has positively impacted over 600,000 lives till date. Glenmark Foundation, the company's CSR arm has been implementing several projects for the benefit of the less privileged sections of the society under three core areas: Child Health, Sustainable Livelihood, and Employee Volunteering. "The award is a testament to our continued commitment of enriching lives and making a positive difference in the communities in which we operate. It acknowledges Glenmark' s contribution in impacting over 600,000 lives through our initiatives in Child Health, Sustainable Livelihood, providing access to healthcare through medicine donation, and global employee volunteering programs. I am sure this prestigious recognition by a leading industry body will provide us the impetus to pursue our mission of enriching lives with renewed vigour," said Ms Cheryl Pinto, director, corporate affairs, Glenmark. The Civic Awards are presented by the BCCI every year to publicly acknowledge and honor notable achievements undertaken by corporate organizations to improve their environmental, social, and cultural metrics by way of services to the community in addition to outstanding operational performance. ]]> <![CDATA[Baxter, Merrimack sign for pancreatic cancer drug]]> https://biospectrumindia.com/news/95/4548/baxter-merrimack-sign-for-pancreatic-cancer-drug.html https://biospectrumindia.com/news/95/4548/baxter-merrimack-sign-for-pancreatic-cancer-drug.html Fri, 26 Sep 2014 11:22:44 +0530 Baxter International and Merrimack Pharmaceuticals jointly announced an exclusive license and collaboration agreement for the development and commercialization of MM-398 (nanoliposomal irinotecan injection), also known as 'nal-IRI'. Under the terms of the agreement, Merrimack receives a $100 million upfront payment from Baxter. Through this pact, Baxter gains exclusive commercialization rights for all potential indications of MM-398 outside the United States and Taiwan, and Merrimack retains commercialization rights in the United States. The rights in Taiwan are held separately. MM-398 is an investigational drug candidate for which Merrimack is preparing a New Drug Application in the United States for the treatment of patients with metastatic pancreatic cancer previously treated with a gemcitabine-based therapy. "Oncology represents an exciting new area and growth driver for our biopharmaceutical business," said Dr Ludwig Hantson, president, Baxter BioScience. "With this new collaboration we continue to augment our growing pipeline focused on challenging diseases with significant unmet needs, while capitalizing on our broad global reach." Merrimack is also eligible to receive $220 million in future development and regulatory milestone payments related to two additional indications. Merrimack has the potential to receive $250 million in sales milestone payments, as well as tiered royalties on net sales of MM-398 in the licensed geographies. ]]> <![CDATA[Merck Serono to invest $130+ million in biosimilars]]> https://biospectrumindia.com/news/95/4505/merck-serono-to-invest-130-million-in-biosimilars.html https://biospectrumindia.com/news/95/4505/merck-serono-to-invest-130-million-in-biosimilars.html Thu, 25 Sep 2014 18:07:10 +0530 Hinging on the results of its Phase I studies, Merck Serono plans to invest more than $130 million in biosimilars in 2015. This is in addition to its previous investment in biosimilar worth â‚¬100 million this year. ]]> <![CDATA[Pfizer to takeover Actavis?]]> https://biospectrumindia.com/news/95/4506/pfizer-to-takeover-actavis.html https://biospectrumindia.com/news/95/4506/pfizer-to-takeover-actavis.html Thu, 25 Sep 2014 18:05:17 +0530 However, there has been no formal confirmations from both the companies yet. This year, Pfizer was also keen on acquiring biopharmaceutical giant AstraZeneca for a staggering $118 billion. But the discussions over the acquisition did not reach fruition. ]]> <![CDATA[PM Narendra Modi rolls out 'Make in India' plan]]> https://biospectrumindia.com/news/95/5270/pm-narendra-modi-rolls-out-make-in-india-plan.html https://biospectrumindia.com/news/95/5270/pm-narendra-modi-rolls-out-make-in-india-plan.html Thu, 25 Sep 2014 14:47:00 +0530 Prime Minister Mr Narendra Modi today unveiled the "Make in India" campaign, with an aim to turn the country into a global manufacturing hub. It was first proposed by the PM in his Independence Day speech. The government has identified 25 sectors that will be covered under the Make In India plan. The program lays emphasis on these 25 sectors that will focus on job creation and skill enhancement. The campaign, Mr Modi said, "is the step of a lion." The logo is a striding lion made of cogs, symbolising manufacturing, strength and national pride. The Make in India campaign aims at turning the country into a global manufacturing hub by smoothening business processes and attracting foreign companies to set up factories in India and invest in the country's infrastructure. The focus, is on creating jobs and helping the poor reach the middle class faster said the PM. He also emphasised on the need to rebuild investors' trust and provide them with a better investment climate. Mr Modi said promising faster decision making and a better policy environment for global and domestic corporates. Amongst the 25 sectors, following are the areas in the lifescience and healthcare sector covered by the PM. BioTech:India is third biggest biotech industry in the Asia-Pacific region and also has the second highest number of USFDA approved plants. Indian biotech industry will grow at an average growth rate of around 30 percent a year and reach $100 Billion by 2025. The sector has seen high growth with a CAGR in excess of 20 percent and the key drivers for growth in the biotech sector are increasing investments, outsourcing activities, exports and the government's focus on the sector. The Department of Biotechnology has established biotech parks in various parts of the country to facilitate product development, research and innovation, and the development of biotechnology industrial clusters. The parks offer investors incubator facilities, pilot plant facilities for solvent extraction and laboratory and office spaces. Pharma:India is expected to rank amongst the top three pharmaceutical markets in terms of incremental growth by 2020. It is the sixth largest market globally in terms of size.The country's generic drugs account for 20 percent of global exports in terms of volume, making the country the largest provider of generic medicines globally. It is expected to be $45 billion in revenue by 2020. India's cost of production is significantly lower than that of the USA and almost half of that of Europe.Approval time for setting up new facilities in India has been drastically reduced. The country's pharmaceuticals industry accounts for about 2.4 percent of the global pharma industry by value and 10 percent by volume. Wellness:Indian systems of medicine and homoeopathy particularly Ayurveda and yoga are widely recognized for their holistic approach to health and capability for meeting emerging health challenges. India is the second largest exporter of AYUSH and herbal products. India's wellness market is estimated at Rs 490 Billion, and wellness services alone comprise 40 percent of the market. Food processing:India has rich agriculture resource base, the country was ranked No 1 in the world in 2012 in the production of bananas, mangoes, papayas, chickpea, ginger, okra, whole buffalo, goat milk and buffalo meat. The country's gross cropped area amounts to 199 million hectares, with a cropping intensity of 140 percent. The net irrigated area is 89.9 million hectares. India's food processing sector ranks fifth in the world in exports, production and consumption. The contribution of the food processing industry to the gross domestic product in 2012-13 amounts to Rs 845.22 Billion. India's food processing industry has grown annually at 8.4 percent for the last 5 years. The country has established various food parks which is a unique opportunity for entrepreneurs, foreign investors to enter in the Indian food processing sector. ]]> <![CDATA[Soon, cancer can be detected in minutes!]]> https://biospectrumindia.com/news/95/3688/soon-cancer-can-be-detected-in-minutes.html https://biospectrumindia.com/news/95/3688/soon-cancer-can-be-detected-in-minutes.html Tue, 23 Sep 2014 16:16:17 +0530 Providing a ray of hope to the million cancer sufferers' across the globe, British researchers have invented a new biosensor that can detect cancer biomarkers, thus facilitating early diagnosis and treatment. The study published in the journal 2D Materials reported that the new sensor system made of graphene was found to be five times more sensitive than the bioassay tests, currently in use. The team said that the sensor system can be used as a rapid diagnostic tool, given its capability to detect cancer in a few minutes. Mr Owen Guy, study co-author, University of Swansea, said, "Graphene has superb electronic transport properties and has an intrinsically high surface-to-volume ratio which makes it an ideal material for fabricating biosensors." He added that these receptors were able to bind to, or target, a specific molecule present in blood, saliva or urine, thus detecting diseases in their early stages. This opens up the possibility of a rapid, point-of-care diagnostic tool for patients, he further stated. Moving forward Mr Guy said that further research will be conducted to investigate a range of different biomarkers associated with different diseases and conditions. ]]> <![CDATA[Ebola outbreak may last forever: WHO]]> https://biospectrumindia.com/news/95/7697/ebola-outbreak-may-last-forever-who.html https://biospectrumindia.com/news/95/7697/ebola-outbreak-may-last-forever-who.html Tue, 23 Sep 2014 16:16:01 +0530 With the flesh-eating virus continuing to wreak havoc in the West African countries, many Asian countries have rushed to the rescue. Singapore scientists from the Agency for Science, Technology and Research (A*Star) are lending a hand in the Ebola fight by studying the mutation and evolution patterns of the virus. Researchers are examining viral epitopes to determine the best cocktail of antibodies that can kill the virus and contain the spiraling cases in West Africa. Dr Sebastian Maurer-Stroh, senior principal investigator at A*Star's Bioinformatics Institute, said that the research hopes to find antibodies that 'works the best'. Dr Maurer-Stroh added that this work will eventually help in evaluating the mutational properties of the virus as the antibodies extracted from survivors may not work for the current outbreak if the epitopes are too different. The current Ebola epidemic in Africa has caused catastrophic destruction killing more than 2800 people so far. The epidemic is also taking a toll on the economic stability of the African nations that are grappling with the deadly virus. Meanwhile in its emergency meeting convened by the World health Organization, the health governing body said, "Blocking flights to or from affected areas and other travel restrictions only serve to isolate affected countries, resulting in detrimental economic consequences and hinder relief and response efforts, risking further international spread." WHO has further issued a warning that if the outbreak in West Africa is not effectively arrested the epidemic could soon become a permanent fixture in that area. ]]> <![CDATA[GSK and Avalon launch two biotech start-ups]]> https://biospectrumindia.com/news/95/4299/gsk-and-avalon-launch-two-biotech-start-ups.html https://biospectrumindia.com/news/95/4299/gsk-and-avalon-launch-two-biotech-start-ups.html Tue, 23 Sep 2014 14:20:29 +0530 As a part of their collaboration to launch ten early-stage lifescience companies, GlaxoSmithKline (GSK)and Avalon Ventures have launched two biotech start-ups, Silarus Therapeutics and Thyritope Biosciences. Silarus will develop a therapy for anemia and iron overload disorders, targeting the erythroferrone hormone that regulates iron supply for red blood cell production, and Thyritope will focus on Graves' Orbitopathy, which causes thyroid-related bulging of the eyes. There's no approved treatment for this condition, which could lead to orphan treatment by federal regulators. The start-ups will receive $10 million each for the next three years to develop potential drugs. The companies will be housed in COI Pharmaceuticals, which is an Avalon-GSK incubator meant to grow its ten early-stage companies. "By combining the nimble start-up mentality of Avalon with the unmatched R&D expertise and resources of a global pharmaceutical giant like GSK, in less than 18 months we have launched three new companies in diverse therapeutic areas and completed our first compound screen for drug candidate identification in a robust collaboration with GSK. This collaboration has exceeded my expectations in terms of what we've been able to accomplish on such a short timescale," said Mr Jay Lichter, managing director, Avalon in a statement. ]]> <![CDATA[Merck KGaA to acquire Sigma-Aldrich for $17 billion]]> https://biospectrumindia.com/news/95/4442/merck-kgaa-to-acquire-sigma-aldrich-for-17-billion.html https://biospectrumindia.com/news/95/4442/merck-kgaa-to-acquire-sigma-aldrich-for-17-billion.html Mon, 22 Sep 2014 16:48:00 +0530 This deal will offer Merck increased access to Asian markets. Merck will acquire all of the outstanding shares of Sigma-Aldrich for $140 per share in cash. The agreed price represents a 37 percent premium to the latest closing price of $102.37 on September 19, 2014, and a 36 percent premium to the one-month average closing price. The transaction is expected to be immediately accretive to Merck. Guggenheim Securities and J P Morgan are acting as financial advisers to Merck KGaA. Skadden, Arps, Slate, Meagher and Flom LLP is acting as its legal adviser. Morgan Stanley and Co. LLC is acting as financial adviser to Sigma-Aldrich and Sidley Austin LLP is acting as its legal adviser. ]]> <![CDATA[NPPA: Pharma firms should register for IPDMS]]> https://biospectrumindia.com/news/95/7666/nppa-pharma-firms-should-register-for-ipdms.html https://biospectrumindia.com/news/95/7666/nppa-pharma-firms-should-register-for-ipdms.html Mon, 22 Sep 2014 16:21:04 +0530 National Pharmaceutical Pricing Authority (NPPA) has notified pharma companies to register themselves under the Integrated Pharmaceutical Database Management System (IPDMS) for Online filing of Returns. NPPA in collaboration with the National Informatics Center have developed the IPDBMS, which is aimed at facilitating online submission of mandatory returns or reports under the Drug Price Control Order (DPCO), 2013. According to NPPA, "Availability of reliable database is a necessary pre-requisite for carrying out the functions of price fixation and price revision with respect to scheduled drugs; price fixation with respect to new drugs; monitoring the production and availability of scheduled formulations and the active pharmaceutical ingredients contained in the scheduled formulations; and monitoring the prices of non-scheduled formulations." Pharma companies are requested to register and complete all registration formalities, by 30th October, 2014. The reporting obligation is a legal obligation, which the companies are required to carry out with full and correct disclosure of information in a timely manner at prescribed intervals, the regulator said. "Any default in the reporting would be deemed to be an act of contravention of the DPCO 2013 and therefore attracts penalties under the Essential Commodities Act, 1955," it added. ]]> <![CDATA[Himalaya targets 12 percent growth in FY15]]> https://biospectrumindia.com/news/95/4313/himalaya-targets-12-percent-growth-in-fy15.html https://biospectrumindia.com/news/95/4313/himalaya-targets-12-percent-growth-in-fy15.html Mon, 22 Sep 2014 16:18:04 +0530 In the current fiscal year, Himalaya Drug Company is targeting 12 percent revenue growth, about Rs 1450 crore on robust sales in the domestic market. In the FY14, the company generated Rs 1,300 crore. "We are looking at clocking Rs 1,450 crore in revenue in the current fiscal year. Our revenue growth is primarily driven by growth in the domestic market," said the company's CEO Mr Philipe Haydon in a statement. He added, "We are constantly exploring new routes to penetrate our brand across new categories, existing markets, new markets, and multiple demographics." Speaking about the company's business plans, he further added, "Our research pipeline is robust. We are in the advanced stage of drug development for cancer. We are also strengthening our presence in the nutraceuticals segment." Pharmaceutical and personal care contribute majority of the company's revenue, about 38 percent each. The remaining is contributed by baby care and animal health business. ]]> <![CDATA[Lilly's injectable diabetes drug receives FDA approval]]> https://biospectrumindia.com/news/95/4208/lillys-injectable-diabetes-drug-receives-fda-approval.html https://biospectrumindia.com/news/95/4208/lillys-injectable-diabetes-drug-receives-fda-approval.html Mon, 22 Sep 2014 12:53:41 +0530 Trulicity (dulaglutide) was approved by USFDA, which is the latest Eli Lilly's treatment option for adults with type 2 diabetes. Diabetes remains one of society's most prevalent diseases. More than 380 million people around the world suffer from diabetes. Trulicity is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. Trulicity comes in a single-dose pen that does not require mixing, measuring or needle attachment. It is administered once a week, any time of day, independent of meals, and should be injected subcutaneously in the abdomen, thigh or upper arm. The recommended starting dose is 0.75 mg, which can be increased to 1.5 mg dose for patients who need additional blood sugar control. This drug is not recommended as first-line therapy for patients inadequately controlled on diet and exercise. It has not been studied in patients with a history of pancreatitis, and other antidiabetic therapies should be considered for patients with a history of pancreatitis. Trulicity is not for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis. It is also not a substitute for insulin and has not been studied in combination with basal insulin. Lilly said in a statement that this drug has not been studied in patients with severe gastrointestinal disease, including severe gastroparesis, and is not for patients with pre-existing severe gastrointestinal disease. Lilly plans to make Trulicity 0.75 mg and 1.5 mg single-dose pens available for adults in the United States later this year. This marks the first approval for Trulicity anywhere in the world. It has also been submitted to the European Medicines Agency and other regulatory bodies. ]]> <![CDATA[NPPA cuts price on 43 drug formulation packs]]> https://biospectrumindia.com/news/95/5875/nppa-cuts-price-on-43-drug-formulation-packs.html https://biospectrumindia.com/news/95/5875/nppa-cuts-price-on-43-drug-formulation-packs.html Mon, 22 Sep 2014 12:45:44 +0530 The NPPA has capped the prices of formulations including antibiotic Ciprofloxacin, BCG vaccine and anti-diabetic Metformin. "The prices have been fixed and revised in respect of 43 formulation packs, both ceiling and retail price packs, under DPCO, 2013," said NPPA. ]]> <![CDATA[Glioblastoma therapeutics market to double in APAC by 2020]]> https://biospectrumindia.com/news/95/7425/glioblastoma-therapeutics-market-to-double-in-apac-by-2020.html https://biospectrumindia.com/news/95/7425/glioblastoma-therapeutics-market-to-double-in-apac-by-2020.html Sun, 21 Sep 2014 12:49:00 +0530 Glioblastoma multiforme (GBM) therapeutics market in Asia-Pacific (APAC) is estimated to grow double from USD49.4 million in 2013 to USD105.8 million by 2020, at a compound annual growth rate (CAGR) of 11.5 percent, according to market analyst GBI Research. Glioblastoma multiforme is a common and aggressive malignant primary brain tumor in humans. The growth in therapy market is resulted from the anticipated approval and market entries of Rindopepimut, Cotara and Avastin in APAC countries in the coming years. Mr Vijaya Vulapalli, senior analyst, GBI Research, commented, "The APAC region boasts a strong GBM pipeline, which also includes carmustine implants, currently being developed in China. Novel therapies Rindopepimut and Cotara in particular could have a significant bearing on APAC's GBM treatment landscape. "Phase II clinical studies of Rindopepimut demonstrated a relatively high median Overall Survival (OS) rate among patients. Meanwhile, Cotara's Phase II studies showed similar OS to Avastin, with slightly more progression-free survival improvement in recurrent GBM. As a single-infusion therapy, Cotara is likely to become an effective second-line treatment option for patients." However, GBI Research states that even if the therapies prove successful in late-stage clinical trials, they will experience low uptake in their respective markets due to their high prices and lack of patient access to medicines, mainly in China and India. Furthermore, APAC's GBM treatment space is still expected to require new drugs with better efficacy and improved prognosis. Mr Vulapalli continues, "One of the key reasons for the lack of efficacy exhibited by most therapies is their inability to penetrate the blood-brain barrier, and an urgent unmet need will remain over the forecast period for drugs that can achieve this. "Efficacy also remains low because therapeutic resistance develops due to the disease heterogeneity, which is believed to be increased by genetic variations arising from mutations. A combined therapy that acts on multiple tumor signaling pathways, rather than a single molecular target, may therefore be more effective and result in a better prognosis," the analyst concludes. ]]> <![CDATA[Do India's bad quality drugs end up in Africa?]]> https://biospectrumindia.com/news/95/4086/do-indias-bad-quality-drugs-end-up-in-africa.html https://biospectrumindia.com/news/95/4086/do-indias-bad-quality-drugs-end-up-in-africa.html Sun, 21 Sep 2014 10:47:00 +0530 According to a research conducted by the National Bureau of Economic Research, some generic drugs sent from India to Africa are of lower quality, when compared to the same medicines sent to other countries like Russia and China. Tests conducted on 1,470 samples indicated that two widely used antibiotics and two TB treatments, sold in Africa do not contain enough active pharmaceutical ingredient in it. Researchers said, "Inferior versions can be fatal and may promote drug resistance that undermines the future effectiveness of even good quality medicines." FDA has so far banned 36 units in India on grounds of faking and manipulating tests. The list includes even big names like Sun pharma and Ranbaxy. Though the research paper did not cite any names, it clearly stated that lack of appropriate regulations in African countries were an advantage to dump India's worst quality drugs in their markets. Study showed that 17.5 percent of tuberculosis therapy rifampicin sold in Africa tested substandard, which means the drug has less than 80 percent of the active ingredient that it must contain. Authors mentioned, "The risk of being caught in Africa is low because those countries are typically poorer, have a less educated population and do not function well in regulating drug quality. Making poor-quality antibacterials can be a lucrative business because the quality problem is hard to detect by end-users." ]]> <![CDATA[Its a start-studded collaboration for AstraZeneca ]]> https://biospectrumindia.com/news/95/4054/its-a-start-studded-collaboration-for-astrazeneca-.html https://biospectrumindia.com/news/95/4054/its-a-start-studded-collaboration-for-astrazeneca-.html Sat, 20 Sep 2014 12:52:00 +0530 As part of the campaign, Mr Van Der Beek stars in an informative and comedic video, called "Just the Flu Facts," in which he uses his signature sense of humor to debunk common misconceptions about seasonal influenza that are often barriers to vaccination. "As parents of three young children, my wife and I do everything we can to keep our family healthy," Mr Van Der Beek said. "As health-conscious as I am, I was surprised to learn that even I had been subscribing to many commonly-held beliefs about the flu that are actually myths. Because influenza can have a serious impact on the entire family. I felt it was important to help people separate flu fact from fiction." ]]> <![CDATA[Moving technology from Lab-to-land a bottleneck]]> https://biospectrumindia.com/features/95/6229/moving-technology-from-lab-to-land-a-bottleneck.html https://biospectrumindia.com/features/95/6229/moving-technology-from-lab-to-land-a-bottleneck.html Sat, 20 Sep 2014 10:27:00 +0530 Currently, India's private biofertilizer market is estimated to be worth Rs 500-600 crore and is expected to be growing more. "The issue with biofertilizer and biopesticide market is that there is no proper check and control. The whole concept of organic manure and biofertilizer is getting killed because of the substandard materials used. I feel the government is responsible for this. A lot of awareness is being slowly created among farmers to go organic and chemical-free. This is a positive trend and it is picking up day-by-day," expressed Mr Mahesh G Shetty, MD, Multiplex Group of Companies, throwing light on the existing scenario on the biofertilizer market in India. Multiplex began as a micronutrient manufacturing enterprise and then got into the business of pesticides in 1995-96. Later in 1999, the company's focus turned towards organic manures and biopesticides. Speaking on the biofertilizer industry challenges, Mr Shetty opined, "The major issue is that, as for using biofertilizer in agriculture, the results are not immediate. There are many factors that determine the quality of the products including climate, weather, soil moisture, and pH among others." He also feels that it is imperative to build confidence among farmers. "We need to instill confidence among farmers and the agricultural community that they can grow any kind of vegetables and field crops without using any chemical fertilizers or pesticides. Farmers have lost their confidence in biofertilizers. We need to create awareness among them and venture capitalists," he added. The government needs to identify the right kind of partners since there are hardly any good-quality producing biofertilizer units within the government, he emphasized. Mr Shetty also warns that in India, Chinese products are disguised as bioproducts which are dangerous chemicals and pesticides promoted by the government. Biofertilizer and biopesticides are mostly produced through fermentation process which consume certain amount of time. "The whole process will take about 7-10 days," he explained. "Sadly, most state governments want instantaneous results. Hence, there is no proper pre-planning which is another challenge. Even if the government can give a month as a window period, we'll deliver them quality products. So they need to choose the right partners. Also moving technology from lab-to-land is not happening." In the market today, there are great products that can replace dangerous and poisonous substances used in killing pests in the soil. The bioproducts can work better than chemical fertilizers by being totally harmless to animals, plants and even the soil. The biofertilizer black market is valued at Rs 2000 crore, so well designed, that one would not get a bill as all the payments are done via cash. "The government is not able to track this black market," Mr Shetty lamented. Multiplex has 600+ sales force, enabling it to carry multi location trials, and creating farmer awareness by keeping them fully informed about new innovations in the field of biofertilizers. Some states have been declared as 'organic states' in India. "But this genuinely doesn't happen. Day-by-day chemical fertilizer prices are skyrocketing. This is where huge opportunity rests. With organic fertilizers, it's the other way around. The initial cost are a little high but later it drops down after a few years. This is the biggest advantage of biofertilizer," exclaimed Mr Shetty. For biofuels, he advises that Pongamia will make a good choice. "Pongamia can grow anywhere and everywhere. In rural areas, Pongamia oil is used as an alternative to diesel. It acts as a good replacement," he told. Talking about the future of Indian biofertilizer market, Mr Shetty optimistically said, "The future looks extremely good with the kind of research happening in India. We need to mass multiply and take bioproducts to people who require them. Fermentation is becoming expensive and sophisticated. In laboratory, moving from lab-to-land is a bottleneck. And that's the biggest challenge." Multiplex exports its products to Japan, Ethiopia, Djibouti, UAE, Cypress, Mauritius, Bangladesh and Sri Lanka among others. Mr Shetty concluded saying that biofertilizer is a wonderful field handled badly. "This needs immediate attention. If taken in the right direction, it can really save our precious soil. We can lead healthier lives, and save a lot on foreign exchange because today we import chemical fertilizers and pesticides from other countries," he ended. ]]> <![CDATA['Australia has a strong budget to fund research']]> https://biospectrumindia.com/interviews/95/3964/australia-has-a-strong-budget-to-fund-research.html https://biospectrumindia.com/interviews/95/3964/australia-has-a-strong-budget-to-fund-research.html Fri, 19 Sep 2014 18:17:45 +0530 During their recent visit to India, Australian lifesciences and healthcare mission delegates highlighted the fact that Australia offered a number of grants and lucrative incentives that can attract the Indian biotech industry towards collaborating with their Australian partners. Speaking exclusively to BioSpectrum, Ms Nicola Watkinson, senior trade and investment commissioner-South Asia, Australian Trade commission said that India and Australia faced a few common challenges and an endemic disease burden which can be effectively tackled by collaborative research. What are the opportunities for the Indian biotech industry in Australia? I think there is a good scope of collaboration as both our biotech sectors are growing rapidly. With new viruses exploding, the need for new vaccine research is huge. Australia is keenly looking at partnering with Indian vaccine makers to develop newer drugs and therapies that can benefit the society and prevent outbreaks. The area of tropical health is also a challenge. India and Australia are grappling with some common endemic diseases like malaria and dengue. Together, we can work and solve the challenges of these tropical diseases. Recently, Pune-based Serum institute of India partnered with Sydney-based Neuclone to manufacture high quality, low-cost drugs using biosimilars. How does the Australian government encourage new drug research? Australia offers a number of grants to foster R&D. We have an Australia-India strategic research fund, which is designed to fund collaborative research between Australian and Indian research institutes. The Australian Prime Minister, on his recent visit to India, had announced an extension of that fund by another $20 mn. How is Australia an attractive destination for the biotech industry? We offer R&D tax incentives for companies generating less than $20 million revenue for undertaking R&D in Australia. We have a strong budget to fund research that encourages drug or vaccine development for some of the major humanitarian challenges like rare diseases and infectious epidemics. ]]> <![CDATA[Denovo Biopharma acquires oncology drug from Eli Lilly]]> https://biospectrumindia.com/news/95/3962/denovo-biopharma-acquires-oncology-drug-from-eli-lilly.html https://biospectrumindia.com/news/95/3962/denovo-biopharma-acquires-oncology-drug-from-eli-lilly.html Fri, 19 Sep 2014 17:47:26 +0530 Denovo Biopharma has acquired enzastaurin, a late-stage oncology drug, from Eli Lilly. Lilly developed enzastaurin in a variety of indications, including in Phase 2 and Phase 3 clinical trials for diffuse large B-cell lymphoma (DLBCL). In studies conducted by Lilly, enzastaurin achieved promising clinical results in the DLBCL induction setting in Phase 2 trials, but did not meet the primary endpoint in the DLBCL maintenance setting in the Phase 3 study. A meaningful subset of patients showed significantly improved progression-free survival and Denovo Biopharma intends to conduct genetic analysis to identify biomarkers that are related to this outcome. By identifying genomic biomarkers that correlate with patients' responsiveness to treatment, Denovo plans to screen for appropriate patient subsets for enrollment in future clinical trials that the company plans to conduct. "We appreciate Lilly's extensive efforts in the development of enzastaurin to date. As our first late-stage asset acquired from a premier pharmaceutical company, this high quality data package will enable Denovo to conduct our retrospective biomarker discovery," said Dr Michael F Haller, COO, Denovo Biopharma. "Our biomarker discovery efforts take only a few months, so when combined with Lilly's existing data package, we should be able to rapidly initiate a biomarker validation clinical trial for the original indication (DLBCL). We are actively seeking to acquire additional drugs in late-stage development where we can utilize our biomarker discovery platform to personalize and advance other potential treatments in similar fashion." ]]> <![CDATA[Baxter recalls wrongly labelled Potassium Chloride injection ]]> https://biospectrumindia.com/news/95/3948/baxter-recalls-wrongly-labelled-potassium-chloride-injection-.html https://biospectrumindia.com/news/95/3948/baxter-recalls-wrongly-labelled-potassium-chloride-injection-.html Fri, 19 Sep 2014 17:47:09 +0530 Global biopharmaceutical company, Baxter International, is recalling one lot of Potassium Chloride Injection 10mEq per 100mL, product code 2B0826, in US due to a labeling error on the shipping cartons. According to the company, shipping cartons labeled for Potassium Chloride Injection may contain units of Gentamicin Sulfate Injection, 80 mg in 100 mL, product code 2B0862. Potassium Chloride is indicated for treatment of potassium deficiency and administered intravenously and Gentamicin Sulfate is an antibacterial drug for intravenous administration. As both products are packaged in 100mL containers, have similar code numbers and red labeling on the front panel, there is a potential risk of medication error or delay in therapy for patients that require high concentration potassium chloride. The affected lot of Potassium Chloride Injection was distributed to customers in the United States between May 26, 2014, and August 8, 2014. ]]> <![CDATA[Johnson and Johnson launch a 'Neuroscience Catalyst']]> https://biospectrumindia.com/news/95/4725/johnson-and-johnson-launch-a-neuroscience-catalyst.html https://biospectrumindia.com/news/95/4725/johnson-and-johnson-launch-a-neuroscience-catalyst.html Fri, 19 Sep 2014 16:25:15 +0530 Janssen and J&J Innovation have launched a new project called the 'Neuroscience Catalyst' to drive innovation in neurological research. They plan to set up ten research projects that examine mood disorders, Alzheimer's disease and other such neurological conditions. The idea is to help seed ideas and ultimately spin out startups from academia. "We are particularly excited by this - helping academic entrepreneurs take their ideas to the next level," said Mr Guy Seabrook, vice president of Neuroscience Scientific Innovation at J&J Innovation in a statement. He added, "In the last decade, a lot of big pharma have exited the field of psychiatric disorders, particularly mood disorders. We see that as a big opportunity-finding compounds that work in a matter of days instead of months." Janssen is helping operationalize the academic spinouts, as well as raise downstream venture financing, and design a clear exit strategy. Much like many of these pharma-academia partnerships, J&J will also provide in-kind support, allowing access to its state of the art resources and conducting functions like compound and lab screening. The University of Toronto is co-funding this project, and creating a structure to evaluate research proposals from academic hospitals and research institutions throughout Canada. "Conditions such as dementia and depression affect hundreds of millions worldwide, and that number is rising. By working together in an open innovation partnership, we can conduct the basic research needed to identify new therapeutic options for patients," said Mr Ruth Ross, director of the Center for Collaborative Drug Research, Toronto, in a statement. ]]> <![CDATA[Merck appoints new board execs]]> https://biospectrumindia.com/news/95/3927/merck-appoints-new-board-execs.html https://biospectrumindia.com/news/95/3927/merck-appoints-new-board-execs.html Fri, 19 Sep 2014 13:16:23 +0530 Concurrently, Ms BelÃ©n Garijo (54) was appointed to the executive board to take over leadership for the pharma business. The management changes will become effective as of January 1, 2015. Mr Oschmann, currently CEO pharma, will represent Mr Karl-Ludwig Kley, chairman of the executive board. Both will share strategic management functions and will represent the company with politicians and international organizations. As a member of the executive board, Ms Garijo, currently CEO of Merck's biopharmaceutical division Merck Serono, will take on responsibility for the whole pharma business. Besides Merck Serono, this includes consumer health, allergy and biosimilars. ]]> <![CDATA[Cipla signs deal with Salix]]> https://biospectrumindia.com/news/95/3051/cipla-signs-deal-with-salix.html https://biospectrumindia.com/news/95/3051/cipla-signs-deal-with-salix.html Fri, 19 Sep 2014 10:40:14 +0530 The grant is on a worldwide basis, excluding the countries of Asia (other than Japan) and Africa. Salix is required to make an up-front payment and, upon achievement, additional regulatory milestone payments to Cipla in respect of the new license agreement regarding the 'Rifaximin Complexes' patent rights. Salix also will pay a royalty on net sales of products covered by the 'Rifaximin Complexes' patents licensed to Salix. Last year, Cipla announced the expansion of its existing collaboration with MEDA by granting global commercialization rights for a proprietary combination nasal spray product (fluticasone and azelastine), Dymista. ]]> <![CDATA[Silver Leaf Oak acquires 10% stake in Syngene ]]> https://biospectrumindia.com/news/95/3832/silver-leaf-oak-acquires-10-stake-in-syngene-.html https://biospectrumindia.com/news/95/3832/silver-leaf-oak-acquires-10-stake-in-syngene-.html Thu, 18 Sep 2014 21:21:59 +0530 Silver Leaf Oak (Mauritius) Limited, an investment vehicle advised by India Value Fund Advisors (IVFA) has agreed to acquire a minority 10% stake in Syngene International, Biocon's Research Services subsidiary. Silver Leaf will acquire the stake from Biocon Research Limited (BRL), a wholly owned subsidiary of Biocon Limited at a valuation of Rs 3800 crore. Biocon's shares was at Rs 499.95, up by Rs 13.15 or 2.7% at 1900hrs, on September 18, 2014. The transaction is subject to standard condition precedents including regulatory approvals. Post the completion of this transaction, Biocon and BRL will jointly hold 85.54% stake in Syngene. The Biocon Group was advised by Allegro Advisors. The lawyers for Biocon Group and Silver Leaf Oak were Wadia Ghandy and DSK Legal, respectively. ]]> <![CDATA[Licensing deal: Sun pays $80 million to Merck]]> https://biospectrumindia.com/news/95/3866/licensing-deal-sun-pays-80-million-to-merck.html https://biospectrumindia.com/news/95/3866/licensing-deal-sun-pays-80-million-to-merck.html Thu, 18 Sep 2014 16:57:24 +0530 According to the deal, Sun will pay an upfront payment of $80 million to Merck and will hold the right to market the drug worldwide. The drug is currently said to be evaluated in Phase III registration trials for the treatment of chronic plaque psoriasis, a skin ailment. Merck in a statement said that Sun would fund all the clinical development and regulatory activities relating to the drug. Sun pharma explained that this collaboration is part of its strategy towards building a pipeline of dermatology products. ]]> <![CDATA[Natco pharma and Orchid pharma receives US FDA warning]]> https://biospectrumindia.com/news/95/5586/natco-pharma-and-orchid-pharma-receives-us-fda-warning.html https://biospectrumindia.com/news/95/5586/natco-pharma-and-orchid-pharma-receives-us-fda-warning.html Thu, 18 Sep 2014 15:07:47 +0530 The United Stated Food and Drug Administration (US FDA) has issued warning letter (Form 483) to Natco Pharma and Orchid Chemicals and Pharmaceuticals, according to reports. The letter was issued after the regulatory body found deviations from the standard quality control practices. The US regulator inspected the two companies manufacturing plant earlier this year. The US FDA inspected Natco pharma's dosage facility located in Mahabubnagar district in Telangana. In the letter, the regulatory body has said that the company does not have any written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality and purity they purport or are represented to possess. It further mentioned that the company's quality control unit lacks responsibility to approve or reject procedures that impact quality and purity of drugs. Similarly, the regulatory body has raised concerns over the Orchid Chemicals and Pharmaceuticals's quality system after inspecting its manufacturing unit located in Waluj, Maharashtra in April 2014. It said that the company's test procedures are not scientifically sound and appropriate to ensure that raw materials, intermediates and active pharmaceutical ingredients (APIs) conform to established standards of quality and purity. Also, equipment cleaning/sanitation study does not address microbiological and endotoxin contamination for those processes where there is a need to reduce total microbiological count or endotoxins in the API, or other processes where such contamination could be of concern. ]]> <![CDATA[Ranbaxy receives CID from USDoJ for over pricing]]> https://biospectrumindia.com/news/95/3884/ranbaxy-receives-cid-from-usdoj-for-over-pricing.html https://biospectrumindia.com/news/95/3884/ranbaxy-receives-cid-from-usdoj-for-over-pricing.html Thu, 18 Sep 2014 15:05:41 +0530 The CID is said to be relating to the manner in which it priced certain medical products in the US that are eligible for reimbursement under the Medicaid program. In the US, the Medicaid program is a social health scheme for individuals and families who are poor. The company claims that the CID is a request for documents and information, and is not an allegation of wrongdoing or demand for compensation. However, the company didn't comment anything on which documents or what products, and the kind of information that were requested by the USDoJ. The company would fully cooperate with the civil investigation, it said. A day after its statement to the BSE, On September 18, 2014, Ranbaxy's shares were trading at Rs 606.75, up by Rs 9.10 at 12:37 hrs. ]]> <![CDATA[Glargine trial promising for Mylan, Biocon]]> https://biospectrumindia.com/news/95/7604/glargine-trial-promising-for-mylan-biocon.html https://biospectrumindia.com/news/95/7604/glargine-trial-promising-for-mylan-biocon.html Thu, 18 Sep 2014 15:01:56 +0530 Glargine was developed by India's Biocon which was out-licensed to Mylan for further development. According to Mylan, the trials have been initiated in August 2014 and is expected to culminate in June 2016. The market for this drug is expected to be $3-4 billion worldwide. ]]> <![CDATA[AZ inaugurates Global Technology Center in Chennai]]> https://biospectrumindia.com/news/95/6770/az-inaugurates-global-technology-center-in-chennai.html https://biospectrumindia.com/news/95/6770/az-inaugurates-global-technology-center-in-chennai.html Thu, 18 Sep 2014 12:09:00 +0530 The establishment of this GTC in Chennai will help the company improve the IT organization's efficiency and responsiveness while reducing costs and support 51,500 AstraZeneca employees worldwide. AstraZeneca has significantly invested in this India-based IT hub, both in terms of manpower and technology. The center will drive many of the IT tools, technologies and capabilities to that support delivery of AstraZeneca's strategic ambitions. At the launch event, Mr David Smoley, CIO, AstraZeneca commented, "The opening of the Global Technology Center marks a key milestone in our journey to develop a world class IT function for AstraZeneca." The center will house in-house IT teams that will help grow AstraZeneca's IT technology and operational excellence and provide support to global IT services. The center currently employs 60 people, with the aim of expanding this to approximately 300 in the first year. AstraZeneca has committed itself to the development of the region by employing locally and will outsource IT services only by exception." The company is also looking to develop additional technology centers with a second GTC planned for San Francisco in 2015. ]]> <![CDATA[Govt to set up two biotech parks in J&K]]> https://biospectrumindia.com/news/95/3837/govt-to-set-up-two-biotech-parks-in-jk.html https://biospectrumindia.com/news/95/3837/govt-to-set-up-two-biotech-parks-in-jk.html Thu, 18 Sep 2014 11:57:41 +0530 Jammu and Kashmir as a sub Himalayan state has natural resources in great abundance. However, these are yet to be utilized fully as a source for the production of drugs and medicines. Now realizing that, the government in collaboration with various partners has approved the plan to establish two biotech parks in Jammu and Kahmir divisions respectively. While in Jammu division, the park will be based in Kathua district, the Kashmir division's park will be located in Srinagar. The work will first start at Kathua in Jammu which is a part of Udhampur constitutency of the science and technology minister, Dr Jitendra Singh. The unit will work on medicinal plants. As per Dr Singh, "Biotech is being given a lot of emphasis across the world and so cannot be ignored in the 21st century. India too has to take advantage of its benefits. Our policy is to boost infrastructure by establishing a wide network of biotech parks in India. As a part of the national initiative, a foundation stone laying ceremony is happening shortly at Kathua in Jammu and Kashmir." Detailed plans on the first biotechnology park would be announced at Jammu whereas the second park would be set up in Srinagar later after the flood water recedes and normalcy is restored. The state government has allocated 10 acres of land for each of these biotechnology parks at the State Industrial Development Corporation Area. The plan to build the biotech parks in the flood ravaged state was approved recently by the department of biotechnology in a meeting. The priority of the Srinagar unit would be aromatic herbs. At the moment, approximately Rs 35 crore has been proposed by the state officials and park's technical partners. ]]> <![CDATA[Eli Lilly, AstraZeneca to develop a drug for Alzheimers]]> https://biospectrumindia.com/news/95/3788/eli-lilly-astrazeneca-to-develop-a-drug-for-alzheimers.html https://biospectrumindia.com/news/95/3788/eli-lilly-astrazeneca-to-develop-a-drug-for-alzheimers.html Thu, 18 Sep 2014 11:25:00 +0530 Eli Lilly and AstraZeneca (AZ) have announced a joint collaboration to co-develop and commercialize AZD3293, a drug for Alzheimer's disease. AZD3293 is an oral beta secretase cleaving enzyme (BACE) inhibitor, currently in development as a potential treatment for Alzheimer's. BACE is an enzyme associated with the development of beta-amyloid. Inhibiting BACE is expected to prevent the formation of amyloid plaque and eventually slow the progression of the disease. In phase I studies, it has been shown to reduce the levels of beta-amyloid in the cerebro-spinal fluid of Alzheimer's patients and healthy volunteers. As per the deal, Lilly will pay AstraZeneca up to $500 million in development and regulatory milestone payments. The companies will share all future costs and revenues post-launch. "Lilly has been committed to research in Alzheimer's disease for more than 25 years, and we're dedicated to developing new medicines that can change and modify the course of this devastating disease. Our pipeline of potential medicines and diagnostic agents targeting the known hallmarks of the disease has been bolstered by this alliance with AstraZeneca, a strong strategic partner who shares our passion to bring new medicines to patients suffering from this debilitating illness. This alliance moves us one step closer to achieving our goal of making Alzheimer's dementia preventable by 2025," said Mr David Ricks, Lilly senior vice president and president, Lilly Bio-Medicines. Mr Mene Pangalos, executive vice president, Innovative Medicines and Early Development at AstraZeneca said, "Alzheimer's disease is one of the biggest challenges facing medical science today and BACE inhibitors have the potential to target one of the key drivers of disease progression. We are looking forward to working with Lilly, a company with a long term commitment to and expertise in treating Alzheimer's disease. We believe that, by combining the scientific expertise from our two organizations and by sharing the risks and cost of late-stage development, we will be able to accelerate the advancement of AZD3293 and progress a promising new approach to support the treatment of Alzheimer's patients around the world.'' ]]> <![CDATA[Quintiles launches Emerging Biopharma Solution]]> https://biospectrumindia.com/news/95/5457/quintiles-launches-emerging-biopharma-solution.html https://biospectrumindia.com/news/95/5457/quintiles-launches-emerging-biopharma-solution.html Thu, 18 Sep 2014 11:40:00 +0530 Quintiles has announced the launch of its new solution set, 'Quintiles Emerging Biopharma Solution', a new offering designed to meet the unique clinical development needs and goals of bio-pharma companies. "Emerging bio-pharmaceutical companies have been important Quintiles customers throughout our 30+ year history, and we understand the unique challenges they face. This new offering focuses squarely on those challenges-combining an operational model designed to meet these customers' needs with access to Quintiles' global infrastructure, integrated technology, and therapeutic expertise. It is a combination we believe will help provide superior delivery and improve the probability of success for this customer segment," said Ms Paula Brown Stafford, president, clinical development, Quintiles. This new solution is a newly developed operating model that is aligned with the needs of the bio-pharmaceutical companies and leverages a company's integrated technology platform to provide them with real-time data access as well as a transparent view of project performance. It includes senior-level sponsorship for each company. This level of support provides easy access to the unique expertise and operational support required by these companies. ]]> <![CDATA[Union cabinet launches AYUSH mission]]> https://biospectrumindia.com/news/95/3727/union-cabinet-launches-ayush-mission.html https://biospectrumindia.com/news/95/3727/union-cabinet-launches-ayush-mission.html Thu, 18 Sep 2014 10:28:00 +0530 The proposed mission will address the gaps in health services through supporting the efforts of state governments for providing AYUSH health services/education in the country, particularly in vulnerable and far-flung areas. Under NAM special focus will be given for specific needs of such areas and for allocation of higher resources in their Annual Plans. The mission will help in the improvement of AYUSH education through enhancement in the number of upgraded educational institutions; better access to AYUSH services through increase in number of AYUSH hospitals and dispensaries, availability of drugs and manpower; providing sustained availability of quality raw material for AYUSH systems of medicine; and improving availability of quality Ayurvedic, Siddha, Unani, and Homeopathy (ASU&H) drugs through increase in number of pharmacies, drug laboratories and improved enforcement mechanism of ASU&H drugs. India possess an unmatched heritage represented by its ancient systems of medicine like ASU&H which are a treasure house of knowledge for preventive and promotive healthcare. The positive features of the Indian systems of medicine namely their diversity and flexibility; accessibility; affordability, a broad acceptance by a large section of the general public; comparatively lesser cost and growing economic value, have great potential to make them providers of healthcare that the large sections of our people need. ]]> <![CDATA[Profits - A stumbling block for Ebola research]]> https://biospectrumindia.com/news/95/3682/profits-a-stumbling-block-for-ebola-research.html https://biospectrumindia.com/news/95/3682/profits-a-stumbling-block-for-ebola-research.html Thu, 18 Sep 2014 10:03:00 +0530 Global experts have commented that the lack of adequate funding was a major drawback that discouraged research to develop medical interventions for potentially lethal diseases like Ebola. Experts opine that Ebola being a rare disease, it was hard to attract investments to hunt for a vaccine or a cure. Professor Peter Piot, director of the London School of Hygiene and Tropical Medicine, who co-discovered the Ebola virus in 1976, said that until this West African outbreak, Ebola was a very rare disease and not a public health problem. Mr Sylvain Baize, in charge of the Viral Hemorrhagic Fevers Reference Center, France's Pasteur Institute said, "Highly sophisticated P4 labs were necessary for Ebola research due to its extreme lethality. Lack of many P4 labs and qualified personnel to handle such potent viruses too slowed the research." Prof. Piot added many pharmaceuticals are now engaged in hunting a vaccine and that FDA has fast-tracked the process of drug development, given the deteriorating conditions in West Africa. Mr Seth Berkley, head of the GAVI Alliance, a public-private partnership designed to bring vaccines to poor countries, said that incentives must be offered to pharma companies to encourage drug discovery for such rare and lethal outbreaks. He added,"There are many ways to handle this. You can directly finance the vaccine technology transfer, you can provide incentives to companies by funding them directly, you can create an advanced market commitment with supplemental funds to try to make it a good deal for business, you can create a long-term plan for buying the vaccines as an incentive." Mr Berkley said that such aids will encourage many companies to develop drugs for such potent viruses, which if left unattended, may wipe out the world. ]]> <![CDATA[Ranbaxy to commercialize arthritis drug in India]]> https://biospectrumindia.com/news/95/7893/ranbaxy-to-commercialize-arthritis-drug-in-india.html https://biospectrumindia.com/news/95/7893/ranbaxy-to-commercialize-arthritis-drug-in-india.html Wed, 17 Sep 2014 16:53:29 +0530 Infliximab is a biosimilar to Remicade, which is marketed globally for the treatment of inflammatory diseases including rheumatoid arthritis, Crohn's Disease, ankylosing spondylitis, ulcerative colitis, psoriatic arthritis and psoriasis. Ranbaxy and Epirus signed a licensing agreement for Infliximab in January of 2014. Under the terms of the agreement, Epirus will develop and supply Infliximab, and Ranbaxy will register and commercialize it in India as well as in other territories in Southeast Asia, North Africa, and other selected markets. The DCGI has issued the final clearances. Epirus and its commercialization partner Ranbaxy Laboratories are expected to launch the drug, under the brand name Infimab, by the first quarter of 2015. "With these final clearances, we are now able to deliver a high quality product to patients who may not be able to afford current treatment options," said Mr Amit Munshi, president and CEO, Epirus. "We also intend to leverage this clinical data package to support additional regulatory filings in targeted global markets." The biosimilar will be manufactured by Reliance Life Sciences at a facility in Mumbai. ]]> <![CDATA[Lupin, Merck Serono join forces targeting emerging markets ]]> https://biospectrumindia.com/news/95/1176/lupin-merck-serono-join-forces-targeting-emerging-markets-.html https://biospectrumindia.com/news/95/1176/lupin-merck-serono-join-forces-targeting-emerging-markets-.html Wed, 17 Sep 2014 16:48:54 +0530 Lupin will support Merck Serono in the implementation of the company's general medicines portfolio expansion initiative in emerging markets thus addressing local needs for affordable, highâ€?quality medicines. The agreement builds on an established working relationship between the two companies, and could add up to 20 new products to the current portfolio. The first launches are expected in 2016. The partnership covers major markets such as Brazil, Mexico, Indonesia, Philippines alongside several countries in Africa and Central Eastern Europe as well as other countries in emerging markets, focusing on cardiovascular and diabetes diseases. In Africa, medicines will also be supplied for additional therapeutic areas, reflecting local healthcare needs such as availability of antibiotics. "The agreement with Lupin is an exciting new approach for Merck Serono to address local health needs in fastâ€?growing regions with constantly increasing demand for high quality medicines from trusted companies like Merck Serono and Lupin," said Ms Elcin Ergun, head, global commercial, Merck Serono. Sales in the emerging market regions are one of the key growth drivers for Merck Serono amounting to close to â‚¬1.8 billion in 2013. "We look forward to working with Merck Serono leveraging our established worldâ€?class formulation development, manufacturing, supply chain, and regulatory capabilities to produce a range of medications that meet local needs" said Mr Vinod Dhawan, group president, APAC, Africa, Middle East, and Latin America (AAMLA), Lupin. He further added, "This strategic partnership builds on the existing close collaboration between our two companies. We are delighted to enter into this alliance, which is an extension of our existing partnership into a much larger, multiâ€?regional one." Lupin will develop products, provide product dossiers and supply finished products to Merck Serono. Merck Serono will be the marketing authorization holder for the products, and will leverage its strong commercial and medical teams in emerging markets to bring new medicines in its portfolio to customers. ]]> <![CDATA[Merck's osteoporosis drug shows positive results]]> https://biospectrumindia.com/news/95/7742/mercks-osteoporosis-drug-shows-positive-results.html https://biospectrumindia.com/news/95/7742/mercks-osteoporosis-drug-shows-positive-results.html Wed, 17 Sep 2014 14:41:10 +0530 Odanacatib is an investigational cathepsin K inhibitor to be taken once in a week. The company is planning to submit the New Drug Application (NDA) for odanacatib to the US regulatory body FDA by 2015. In the Long-term Odanacatib Fracture Trial (LOFT), odanacatib met its primary endpoints and significantly reduced the risk of osteoporotic hip, spine, and non-vertebral fractures as compared to a placebo. The rates of overall adverse events in LOFT were generally balanced between patients taking odanacatib and placebo. In the study, odanacatib significantly reduced osteoporotic fracture risk. "The effects of odanacatib on fracture risk from the LOFT study are very encouraging," said Mr Michael McClung, LOFT leader and founding director of the Oregon Osteoporosis Center in a statement. Dr Keith Kaufman, vice president, clinical research, diabetes and endocrinology, Merck said, "Merck believes the currently available data support a favorable benefit/risk profile for odanacatib. We want to thank our investigators who conducted the study and the thousands of patients who participated in this study, which is yielding critical insights into the potential of odanacatib in the treatment of postmenopausal osteoporosis." The results of the trial were presented at the American Society for Bone and Mineral Research (ASBMR) Annual Meeting in Houston, Texas. ]]> <![CDATA[Sanofi, MyoKardia collaboration targets genetic heart disease]]> https://biospectrumindia.com/news/95/6210/sanofi-myokardia-collaboration-targets-genetic-heart-disease.html https://biospectrumindia.com/news/95/6210/sanofi-myokardia-collaboration-targets-genetic-heart-disease.html Wed, 17 Sep 2014 14:36:18 +0530 The collaboration provides up to $200 million in equity investments, milestone payments, and R&D services through 2018. MyoKardia is a privately-held US-company, leading the development of precision therapies for genetic heart disease. The collaboration builds upon MyoKardia's pioneering science, which hopes to correct the disruptive effects that disease mutations have on heart muscle contraction. The collaboration, representing one of the largest research and development commitments to genetic forms of cardiomyopathy, encompasses three MyoKardia programs. Two of these programs are focused on hypertrophic cardiomyopathy (HCM) and the other is focused on dilated cardiomyopathy (DCM). In addition, Sanofi and MyoKardia will equally share development costs on the HCM programs following initial demonstration of efficacy in patients, with Sanofi fully covering the development costs of the DCM program. The collaboration is an outgrowth of Sanofi's Sunrise initiative, a strategic partnership model that seeks to invest in early stage opportunities that align with Sanofi's expert development and commercialization abilities. The commitment of resources from Sanofi will accelerate and broaden MyoKardia's basic disease research and will support the shared commitment of bringing desperately needed therapies to patients. Within the collaboration, MyoKardia will drive research and worldwide development activities through early human efficacy studies. Thereafter, MyoKardia will lead worldwide development and US commercial activities for the two HCM programs, where it has retained product rights. Sanofi will lead global development and commercial activities for DCM where it has obtained worldwide rights, and ex-US regulatory and commercial activities to the two HCM programs where it has ex-US commercialization rights. ]]> <![CDATA[Traditional medicines vital in universal healthcare: WHO]]> https://biospectrumindia.com/news/95/6762/traditional-medicines-vital-in-universal-healthcare-who.html https://biospectrumindia.com/news/95/6762/traditional-medicines-vital-in-universal-healthcare-who.html Wed, 17 Sep 2014 13:00:58 +0530 The 67th session of the WHO Regional Committee for Southeast Asia, saw health experts and policy makers from 11 member states, discussing ways to integrate traditional medicines from South Asian countries into their national healthcare systems. Dr Poonam Khetrapal Singh, regional director for WHO, Southeast Asia region, said, "Traditional medical practitioners are primary healthcare providers for millions of people in rural areas. To ensure administration of safe and affordable traditional medicines, it is important to subject these practices to rigorous quality assessments, in order to ensure that there is a regulation of practices, products and practitioners." She added that every country had a unique history of traditional medical practices, most of which are still actively practiced. She further stated that if these medical practices were appropriately integrated into the national health programs, universal healthcare can be achieved using traditional medicines. WHO had mentioned in a recent press release that 10 out of the 11 member nations had a policy for administration of traditional medicines. WHO said that it will continue to support individual countries to create forums for information exchange and develop policy and regulations to ensure that high quality traditional medicines are available to all member nations. The health governing body, however, added that resources supply must be substantially increased for this effective support to be a possibility. ]]> <![CDATA[CDSCO hands new commandments for pharma cos and CROs ]]> https://biospectrumindia.com/news/95/5087/cdsco-hands-new-commandments-for-pharma-cos-and-cros-.html https://biospectrumindia.com/news/95/5087/cdsco-hands-new-commandments-for-pharma-cos-and-cros-.html Wed, 17 Sep 2014 12:51:00 +0530 According to a new order issued by the Central Drugs Standard Control Organization, pharma companies and clinical research organizations (CROs) now need to explain and justify their research while conducting clinical trials in India.Companies now are mandatorily expected to lay out all the parameters during the application filing process. The parameters include assessment of risks versus benefits to patients, innovation details and existing therapeutic treatments, and information on unmet medical needs. ]]> <![CDATA[Roche starts phase III trial of its eye drug]]> https://biospectrumindia.com/news/95/5622/roche-starts-phase-iii-trial-of-its-eye-drug.html https://biospectrumindia.com/news/95/5622/roche-starts-phase-iii-trial-of-its-eye-drug.html Wed, 17 Sep 2014 11:52:00 +0530 Swiss drugmaker Roche announced that it has started late-stage trials of its experimental drug, Lampalizumab. The drug is to be used in the treatment of Geographic Atrophy (GA), a leading cause of blindness in adults over 55. In this study, the company will investigate how lampalizumab can slow the progression of GA, which affects more than 4.5 million people worldwide. The phase II trial of the drug showed a 20 percent reduction in GA lesion progression in patients treated monthly with the drug as compared with Sham at 18 months. "Lampalizumab has the potential to present a significant breakthrough for this disease and could provide real hope. It is the first complement targeted therapy for GA to enter Phase III and the only ophthalmic drug in clinical development that specifically targets complement factor D," said Ms Sandra Horning, Roche's chief medical officer in a statement. ]]> <![CDATA[Merck receives marketing authorization for NOBILIS]]> https://biospectrumindia.com/news/95/5615/merck-receives-marketing-authorization-for-nobilis.html https://biospectrumindia.com/news/95/5615/merck-receives-marketing-authorization-for-nobilis.html Wed, 17 Sep 2014 10:00:00 +0530 NOBILIS IB Primo QX will be the first vaccine developed using SPHEREON technology in the EU, which freeze-dries live vaccines to small, highly soluble particles (spheres) that allow for packaging in light-weight aluminum cups in convenient dose sizes, claims Merck in a media statement. This vaccine is given to chickens from one day of age or older by spraying onto the chickens or by applying by eye-drop, and provides protection for eight weeks. ]]> <![CDATA[Baxter's RIXUBIS gets US FDA nod]]> https://biospectrumindia.com/news/95/4747/baxters-rixubis-gets-us-fda-nod.html https://biospectrumindia.com/news/95/4747/baxters-rixubis-gets-us-fda-nod.html Tue, 16 Sep 2014 14:26:55 +0530 Baxter International has announced that the United States Food and Drug Administration (US FDA) has approved RIXUBIS [Coagulation Factor IX (Recombinant)] for routine prophylactic treatment, control and prevention of bleeding episodes, and perioperative management in children with hemophilia B. RIXUBIS was the first recombinant factor IX (rFIX) approved for routine prophylaxis and control of bleeding episodes in the US for adults living with this chronic condition. ''In addition to the positive reception we've received from adult RIXUBIS patients, the approval for pediatric patients offers a valuable new option, particularly as our clinical data demonstrated a significant reduction in bleeding episodes for patients who were treated prophylactically, an important factor for this young patient population,'' said Mr John Orloff, vice president of global research and development at Baxter BioScience. The drug is also currently under review with the European Union (EU), and the regulatory decision is expected later this year. The treatment recently gained regulatory approval in Australia. ]]> <![CDATA[Google's Calico focuses on neurodegenerative disorders R&D]]> https://biospectrumindia.com/news/95/4751/googles-calico-focuses-on-neurodegenerative-disorders-rd.html https://biospectrumindia.com/news/95/4751/googles-calico-focuses-on-neurodegenerative-disorders-rd.html Tue, 16 Sep 2014 12:18:00 +0530 Last week, UT Southwestern researchers published a new paper about the molecular target of P7C3 compounds, a class that has been shown to help in various animal models of neurodegeneration. UT Southwestern previously licensed the P7C3 compounds to Dallas-based 2M Companies. 2M and Calico have now entered into a new license agreement under which Calico will take responsibility for developing and commercializing the compounds resulting from the research program. Under the agreement, Calico will fund research laboratories in the Dallas area and elsewhere to support the program. Mr Hal V Barron, president, R&D, Calico, said, "This is an important collaboration for Calico. We look forward to working with the world-leading scientists who discovered the P7C3 class of molecules to learn whether the remarkable biological effects can be translated to the treatment of human disease." In 2010, UT Southwestern entered a licensing agreement with 2M Companies for the P7C3 program. Today's agreement between 2M and Calico is an important further step in the process to commercialize these compounds. Under this agreement, 2M grants to Calico an exclusive worldwide license to the P7C3 program and other NAMPT modulators in exchange for an unspecified up-front fee, milestones, and royalty payments. Calico is the Google-backed life sciences company led by Mr Arthur D Levinson, former chairman and CEO of Genentech. Ms Melissa Krauth, head, life science investments, 2M and its affiliate Claria Bioscience, commented, "After many years of fruitful collaboration with UT Southwestern and the P7C3 inventors, we are delighted to place the P7C3 program in the very capable hands of the Calico team. This agreement validates our strategy of partnering with exceptional scientists and investing in early-stage, high-impact technologies to advance them toward the clinic." ]]> <![CDATA[Research achievements of NRC in seed spices appreciated]]> https://biospectrumindia.com/news/95/6484/research-achievements-of-nrc-in-seed-spices-appreciated.html https://biospectrumindia.com/news/95/6484/research-achievements-of-nrc-in-seed-spices-appreciated.html Tue, 16 Sep 2014 12:00:00 +0530 Dr S Ayyappan, secretary, Department of Agriculture Research (DARE) and director general, Indian Council for Agriculture Research (ICAR) visited National Research Center on Seed Spice (NRCSS), Tabiji, Ajmer recently. He visited various labs, research farm area and facilities of the institute and addressed a meeting with the staff of NRCSS including scientists and technical and administrative staff. Dr Ayyappan emphasized on the major areas and key issues related to seed spice research and development in the country, such as diversified approach, total factor productivity, secondary agriculture, technology impact study, bio fortification, value addition, farming system models, use of bioinformatics, phenomics, commercialisation of technologies and attracting and retaining youth in agriculture. He stressed upon the need to give a major focus for enhancing productivity and quality in seed spice production and expressed his satisfaction on the achievements. Dr Balraj Singh, director, NRCSS presented a brief report of ongoing research programs at the institute and research and development achievements for the last two years that got appreciation from the DG, ICAR. Dr G N Mathur, project co-ordinator, KVK, Tabiji, Ajmer and scientists from KVK were also present during the meeting. ]]> <![CDATA[India, China recreate Barefoot Doctors]]> https://biospectrumindia.com/news/95/3914/india-china-recreate-barefoot-doctors.html https://biospectrumindia.com/news/95/3914/india-china-recreate-barefoot-doctors.html Tue, 16 Sep 2014 10:28:00 +0530 A team of Indian and Chinese doctors have jointly launched the fourth medical mission to provide free consultations and medical advice. This is to boost healthcare services in the poorer regions of both the countries. In a bid to retrace the spirit of 'Barefoot doctors' first undertaken by Dr Dwarakanath Kotnis in 1938, a nine-membered team of Indian doctors and specialists across all medical branches have joined their Chinese counterparts to treat patients at city, district, and village levels for a week in China's Yunnan province. The China-India joint medical mission was announced at an event held by the Chinese People's Association for Friendship with Foreign Countries (CPAFFC) and the China-India Friendship Association (CIFA) recently at Kunming city, to mark the 76th anniversary of Aid-China India Medical Mission. Dr Kotnis, an iconic figure in China, died treating the injured during the Mao revolution in China, 71 years ago. To commemorate the spirit of selfless service and dedication of Dr Kotnis, the joint medical mission dispatches outstanding doctors to provide free medical consultations to the needy of both the nations. ]]> <![CDATA[USFDA 'surprises' Sun Pharma]]> https://biospectrumindia.com/news/95/4333/usfda-surprises-sun-pharma.html https://biospectrumindia.com/news/95/4333/usfda-surprises-sun-pharma.html Mon, 15 Sep 2014 15:12:12 +0530 According to sources, USFDA's visit is owed to the fact that the company recently recalled three important products from the US market, which were produced at Halol plant. In May, USFDA also issued a warning on failing to keep GMPs at its Karkhadi unit in Gujarat. ]]> <![CDATA[â€œHealth must be included in the international diplomatic formatâ€? ]]> https://biospectrumindia.com/news/95/4728/health-must-be-included-in-the-international-diplomatic-format-.html https://biospectrumindia.com/news/95/4728/health-must-be-included-in-the-international-diplomatic-format-.html Mon, 15 Sep 2014 14:55:00 +0530 Returning from Dhaka, where he attended a multilateral meeting organised by WHO for the 11 health ministers from the Southeast Asia region, Dr Harsh Vardhan said, "I have informally proposed that a regional meeting of foreign and health ministers under one roof be held as a first step, and WHO agreed in principle to build upon the idea and make it a reality. "No country, however rich and powerful, has the capability to marshal all the intellectual and physical resources that are necessary to fight the rising burden of communicable as well as non-communicable diseases. They want to reach out to give as well as receive cooperation. It is time to institutionalize this in the rubric of international diplomacy," said the health minister. Given the scary global disease burden scenario, it is necessary to give health a permanent place in the format of international diplomacy. Countries need to both externalize and internalize health paradigms as, in the globalized world, there is no room for complacency. He pointed out that this is the age of "regional strategies" and "global initiatives". For instance, the just-concluded Dhaka meet saw the adoption of a resolution titled "Regional strategy for strengthening the role of the health sector in civil registration and vital statistics". A Memorandum of Understanding (MoU) on traditional medicine was signed between India and Bangladesh and an existing MoU on cooperation against kala-azar involving India, Bangladesh, and Nepal was expanded to include Thailand and Bhutan. "No country is an island. Globalization does not only mean the conversion of the world into a common market. It also means the freedom to exchange ideas and collaborate for achieving a human development goal," Dr Harsh Vardhan added. Dr Harsh Vardhan addressed the opening session of the regional conference and went on to have bilateral meetings with the health ministers of Bangladesh, Nepal, Bhutan, Myanmar, Sri Lanka, Maldives, Timor-Leste, and Indonesia. He also called on the Prime Minister of Bangladesh, Ms Sheikh Hasina. As a WHO Adviser-Consultant in the early 2000s, Dr Harsh Vardhan had visited most of the countries of the region to assist them in polio eradication. Today, the entire region has become polio free with not a single new case reported for over three years. "I have made clear to my interlocutors that I want the best lessons from the world of public healthcare to flow through India's systems. They too appreciated that India too has a lot of success stories to share," Dr Harsh Vardhan said. For example, Bangladesh's community clinics, its emphasis on making women the chief beneficiaries of progressive policies based on evidence of its multiplier effect, have combined to improve its overall health profile. Sri Lanka has drastically reduced its maternal and infant mortality rates. Maldives has practically eradicated malaria. Indonesia's success with health insurance holds out lessons for India which is in the process of introducing universal health insurance. Dr Harsh Vardhan's conception of diplomacy goes beyond government-to-government handshakes. Involving the non-government sector is also on his agenda. That is why he held a meeting with Dr Zafarulla Chowdhury, head of Gonosasthya Kendra, and father of Bangladesh's National Drug Policy. "Dr Chowdhury and I are believers in rational drug use and resolving the pressing problem of unavailability of human resources with innovative ideas. That is why I wish to get into idea exchange with this scholarly and experienced health activist," he said. Similarly, Dr Harsh Vardhan had a meeting with Dr Saima Wazed Hossain, who received a WHO award this week for her fight against neural development disorder and autism. "I agree with her idea of a global partnership against autism. Incidentally the WHO meet saw participants stress the need for a coordinated and comprehensive response to the challenge of Autism Spectrum Disorders in the Southeast Asia region. The government of Bangladesh has embraced many of her recommendations," he pointed out. The health minister also had substantive talks with Dr Margaret Chan, director-general of WHO, and Dr Poonam Khetrapal Singh, the regional director. Both the senior functionaries agreed to back India's focused initiatives on fighting measles, vaccine preventable diseases, and other non-communicable diseases. The health ministers adopted the Dhaka Declaration on vector-borne diseases which calls for adoption of steps to control and eliminate malaria, lymphatic filariasis, and kala-azar. About 1.4 billion are vulnerable to malaria, 871 million to lymphatic filariasis and 147 million to kala-azar. Fifty two percent of the world's dengue-vulnerable people live in these 11 countries. ]]> <![CDATA[5 Indian firms to sell Hepatitis C drug in 90 countries]]> https://biospectrumindia.com/news/95/5886/5-indian-firms-to-sell-hepatitis-c-drug-in-90-countries.html https://biospectrumindia.com/news/95/5886/5-indian-firms-to-sell-hepatitis-c-drug-in-90-countries.html Mon, 15 Sep 2014 14:47:00 +0530 Approximately 180 million people live with Hepatitis C today, with 350,000 people dying annually of the disease. New oral drugs like sofosbuvir and ledipasvir, known as direct-acting antivirals (DAAs), hold significant promise to improve treatment outcomes for Hepatitis C patients around the world, with studies showing high cure rates. US and EU regulators have approved two new DAAs within the last 10 months, and others are in development. However, the high prices set by Gilead for sofosbuvir, for example, are an important barrier to scaling up access to diagnostics and treatment. Increasing generic competition is an important strategy in reducing prices and increasing sustainable affordable access when companies file for patent protection for essential medicines. Although the Gilead agreements will allow some generic companies to market generic versions of both drugs in approximately 90 countries regardless of the patent status in those countries, most of the countries expected to be included in the license agreements are low-income economies, many of which may not have had patent protection on these new drugs in the first place. "Gilead's licensing terms fall far short of ensuring widespread affordable access to these new drugs in middle-income countries, where over 70 percent of people with Hepatitis C live today. Gilead's deal excludes many middle-income countries considered by industry to be profitable emerging markets, even though people living with chronic Hepatitis C in these countries often come from poor and marginalized communities with little ability to pay for expensive medicines," Mr Rohit Malpani, director, policy and analysis, MÃ©decins Sans FrontiÃ¨res, Access Campaign. Hepatitis C is especially prevalent in middle-income countries - with approximately 73 percent of the burden in these countries - but disappointingly many of these countries remain excluded from accessing both Gilead's lowest price and the generic versions licensed by these agreements. It remains to be seen whether in reality the terms and conditions offered by Gilead will enable widespread access to an optimised and affordable regimen needed for millions of people in low and middle income countries, including patients seeking treatment from MSF. MSF (MÃ©decins Sans FrontiÃ¨res) is preparing to initiate treatment in a few medical projects using new direct acting antivirals for people living with chronic HCV. "We welcome the interest of generic companies to scale up production of new direct-acting antivirals and Gilead's decision to make the final agreement public; however, a highly restrictive voluntary license that blocks millions of people with Hepatitis C from affordable prices is not acceptable. MSF hopes that excluded governments will take all relevant measures available under global trade rules and national patent laws to secure low-cost generic versions of these medicines," Mr Malpani added. ]]> <![CDATA[Cadila Healthcare eyeing US, Europe markets]]> https://biospectrumindia.com/news/95/4332/cadila-healthcare-eyeing-us-europe-markets.html https://biospectrumindia.com/news/95/4332/cadila-healthcare-eyeing-us-europe-markets.html Mon, 15 Sep 2014 14:40:56 +0530 With an eye on advanced markets like US and Europe, India's Cadila Healthcare has said that it would soon start filings for approval of its innovator drug Lipaglyn there. As per news reports, the drug is said to have current patients base of 50,000 in India within the first year of its launch. Speaking to news media, Mr Ganesh Nayak, chief operating officer and executive director, Cadila Healthcare explained, "We launched Lipaglyn in the country on September 16 last year and we have till date 50,000 satisfied patients using the product. We have around 3,000 diabetologists, cardiologists and physicians. For us, this forms a good database. Now, we can take this product to the world." Mr Nayak added that the three biggest markets globally are the US, Europe and Japan. "We will simultaneously start filing in these markets and the regulatory process will start within the next few months. Within the next three-to-five years we would bring in our lipaglyn at the global level in terms of sales and marketing. Japan will take a little more time since there are some technical requirements in that market. Also to market in these places, we might look at different modules of selling this product there." Lipaglyn, to be used to treat diabetic dyslipidemia and hypertriglyceridemia in Type II diabetes, is the first new chemical entity (NCE) discovered and developed indigenously by an Indian pharma company. This drug has a unique dual action of working on both glycemic control and the lipid controls. ]]> <![CDATA[Novel genetic screening technique to identify mutations]]> https://biospectrumindia.com/interviews/95/5434/novel-genetic-screening-technique-to-identify-mutations.html https://biospectrumindia.com/interviews/95/5434/novel-genetic-screening-technique-to-identify-mutations.html Mon, 15 Sep 2014 12:44:00 +0530 Almost 15 years have passed since the human genome was mapped in its entirety, and genes responsible for various diseases have been identified. But it is also true that the genetic pattern undergoes changes later during life, and there may be some differences in the genes present in different organs of the body. They undergo mutations, or spontaneous changes, which may result in genetic disorders and in some cases serious malformation of body organs. Hence it is crucial for clinicians and scientists to be able to uncover these mutations but several studies have suggested that existing techniques of genetic screening may not be adequate.Hence Dr Saumya Jamuar, researcher at Harvard Medical School and Boston Children's Hospital, co-founder of Global Gene Corp, along with Prof Christopher Walsh, MD, PhD, chief of Genetics and Genomics at Boston Children's Hospital, have developed a new technique known as "targeted high-coverage sequencing". What is somatic mutation and how is it different from germline mutation?When cells divide and grow, the DNA sequences are supposed to be copied and duplicated but sometimes the copy is not an exact replica of the earlier version. This is because of mutations or changes in the DNA sequence, which constitutes the genes. If the mutations take place in the post-zygotic phase, that is, after the male and female reproductive cells (sperm and 'egg') have come together, then these mutations are called "somatic mutations." These are neither inherited from an earlier generation (of the organism: plant or animal) nor are they passed on to the offspring.On the other hand, a germ-line mutation is a genetic change in the reproductive cells (also called germ cells) and these mutations are inherited and transmitted from one generation to another. This is also a hereditary mutation.What is the significance of these mutations?As can be imagined, the growth and functioning of various organs of the body are controlled through the genes, and mutations can have an impact on them. The impact of germ-line mutations is greater and more widespread than somatic mutations, mainly because the latter happens very early in the development of an organism. The somatic mutations often have rather harmless effects, such as the reddish colour of an apple.The germ-line mutations can be much more impactful, and in rare cases, a single mutation if untreated can lead to conditions that ultimately cause death. What are the causes of genetic mutation?One of the common sources of genetic mutation is inheritance; a mutation that is passed on from one generation to another. This type of mutation is present throughout a person's life in virtually every cell in the body. Sometimes mutations can occur just after fertilisation has occurred, and these may explain genetic disorders in which an affected child has a mutation in every cell, but has no family history of the disorder. Somatic mutations are also caused by environmental factors such as exposure to ultraviolet radiation, etc.How are genetic mutations detected?There are different methods that labs use for genetic testing. Some lab methods look for large deletions and/or duplications, and others look for point mutations. If the mutation in the family is already known, use a method that finds that type of mutation. If the mutation in the family is not already known, start with testing for large deletions and duplications as the first step. These together are the most common causes of the condition like DMD/BMD. If the lab does not find a deletion or duplication, move on to a method that finds point mutations.How can it be said that present detection techniques are not enough?Sometimes one test isn't enough (eg: when it comes to detecting hereditary breast and ovarian cancer), according to findings published in a recent issue of the American Journal of Human Genetics. Researchers uncovered genetic mutations, previously missed by standard gene tests, in the breast cancer gene BRCA1, adding to a growing body of evidence that says current screening methods are not enough.Could you explain how your study helps to solve this problem?In our study, which was published in the August 21 issue of The New England Journal of Medicine, we studied 158 patients with brain malformations of unknown genetic cause, who had symptoms such as seizures, intellectual disability and speech and language impairment. Rather than analyzing the whole genome or exome (protein-coding regions of genes), we focused on a panel of known or suspected genes, but drilled deeper than the traditional genomic sequencing technique. Whole genome or exome sequencing typically breaks the DNA into little fragments, each of which is read multiple times-typically 30-to find the disease-causing mutation. But 30 reads aren't statistically enough to catch mutations that only occur in 15 to 20 percent of our cells-especially given that mutations may affect just one of our two copies of a gene. Hence my colleagues and I scaled up the number of reads, sequencing each candidate gene not 30 but greater than 200 times. This enabled them to find mutations in 27 of the 158 patients (17 percent). Of these, 8 mutations (30 percent) occurred in only a proportion of the blood cells (so-called mosaic mutations)-5 of these 8 were missed by traditional gene sequencing, and one was missed on previous whole-exome sequencing. What is the significance of the latest study? This new approach enhances whole-genome and whole-exome sequencing. We found that approximately 30 percent of patients with an identified mutation had a somatic mutation, 63 percent of which would have been missed in traditional testing. This has huge implications for researchers studying similar disease conditions such as autism, schizophrenia, etc. It changes the way we think about genetic diseases and lastly, translates into clinically relevant diagnostic tool that can help reach a patient's diagnosis. With increasing diagnosis and awareness of these mutations, the hope is that it would lead to identification of a potential target for mediation and cure. Please note: The interview was done by the internal communication team of Ketchum Sampark. No BioSpectrum journalist was involved. ]]> <![CDATA[Genzyme announces positive interim results of its MS drug]]> https://biospectrumindia.com/news/95/6951/genzyme-announces-positive-interim-results-of-its-ms-drug.html https://biospectrumindia.com/news/95/6951/genzyme-announces-positive-interim-results-of-its-ms-drug.html Sat, 13 Sep 2014 12:32:00 +0530 Genzyme's multiple sclerosis drug, Lemtrada (alemtuzumab) has shown positive interim results in the second year of its extension study. In these studies, Lemtrada was given as two annual courses, one at the start of the study and other 12 months later. The study found that, relapse rates and sustained accumulation of disability remained low among patients who had previously received the drug in any of the Phase III CARE-MS I and CARE-MS II studies. No new safety signals were identified. "These extension study results provide further evidence of the prolonged efficacy of Lemtrada on both relapses and disability. The majority of patients continued to experience reduced disease activity, even though their last Lemtrada treatment was three years earlier," said Dr Alasdair Coles, senior lecturer, Department of Clinical Neurosciences, University of Cambridge. More than 90 percent of the patients who were treated with Lemtrada in the Phase III trials enrolled in the extension study. The results of the study will be presented at the European Committee for Research and Treatment in Multiple Sclerosis meeting in Boston. ]]> <![CDATA[Diabetes triggering TB in India: Study]]> https://biospectrumindia.com/news/95/4586/diabetes-triggering-tb-in-india-study.html https://biospectrumindia.com/news/95/4586/diabetes-triggering-tb-in-india-study.html Sat, 13 Sep 2014 11:57:00 +0530 The findings of the study, which was published in the British medical journal Lancet, place India at the top of the list of countries with the highest estimated number of adult TB cases associated with diabetes. India has the highest number of diabetic patients in the world and is also referred to as the world's TB capital. It is followed closely by China and South Africa. "These findings highlight the growing impact of diabetes on TB control in countries where both diseases are prevalent," said Dr Knut Lonnroth, author of the study and a part of the global TB program, WHO in Geneva. He added, "TB control is being undermined by the growing number diabetes patients, which is expected to reach an astounding 592 million worldwide by 2035." The study indicates that 15 percent of adult TB cases worldwide are attributable to diabetes. These diabetes-associated cases correspond to over 1 million cases a year, out of which, more than 40 percent occur in India and China. If diabetes continues to grow out of control, the downward trajectory in global TB cases could be offset by 8 percent or more by 2035, warn the authors of the study. ]]> <![CDATA[Vaccine administration with PFS evaluated in India]]> https://biospectrumindia.com/news/95/4331/vaccine-administration-with-pfs-evaluated-in-india.html https://biospectrumindia.com/news/95/4331/vaccine-administration-with-pfs-evaluated-in-india.html Sat, 13 Sep 2014 11:03:00 +0530 US-based BD Medical-Pharmaceutical Systems in partnership with Indian Academy of Pediatrics Committee on Immunization (IAPCOI) completed a time and motion study to assess the impact on vaccination efficiency with pre-filled syringes (PFS). Time and motion research studies helped determine a significant reduction in time, errors and other health hazards with the usage of PFS. The study was conducted for the first time in India. It demonstrated the superiority of PFS over single and multi-dose vials in terms of the time taken for vaccination, vaccinator productivity, vaccine wastage, waste generated, and errors occurring during vaccination. It was an in-vitro study conducted in Mumbai, Hyderabad, Bengaluru, Delhi, and Kolkata. It assessed the effectiveness of the delivery device or PFS. Vaccination in India is still, predominantly, uses multi-dose vials (MDVs) but PFS offers many advantages over MDVs in terms of efficiency and safety. The study found that the usage or penetration of PFS in developing countries is as low as one percent while in the US, it is 30 to 40 percent and 80-90 percent in Europe. Mr Murli Sundrani, director, BD Medical-Pharmaceutical Systems, "The Time And Motion study has confirmed the advantages of single-dose, ready-to-use devices like PFS as they offer benefits such as lesser injection time, lesser errors, and much better productivity to patients, clinicians, and public health users. Collaboration with IAP-COI has helped us confirm that PFS' are risk reducers, as they reduce the occurrence of handling errors and associated health hazard risks as compared to vials." "PFS had the least scores in the significant Handling errors and Health Hazard Risk (HHRE) scores. The advantages of PFS have been acknowledged by the Centers for Disease Control and Prevention (CDC), which now recommends it as the preferred system of vaccine administration," said Dr SG Kasi, former member, IAPCOI and principal investigator of the study. ]]> <![CDATA[Asthma treatment market to touch $23.1 bn by 2023]]> https://biospectrumindia.com/news/95/5259/asthma-treatment-market-to-touch-23-1-bn-by-2023.html https://biospectrumindia.com/news/95/5259/asthma-treatment-market-to-touch-23-1-bn-by-2023.html Sat, 13 Sep 2014 10:51:00 +0530 The asthma treatment market value with a Compound Annual Growth Rate (CAGR) of 3.8 percent will grow to $23.1 billion by 2023, across eight major countries (the US, UK, France, Germany, Spain, Italy, Japan, and Australia), according to research and consulting firm, GlobalData. As of 2013, the market was worth $15.9 billion. The report estimated that it will be driven largely by the expanding share of targeted biologics in the treatment of severe asthma. Ms Valentina Gburcik, senior analyst, GlobalData, said, "While the market share of fixed-dose combinations of inhaled corticosteroids and long-acting beta-agonists (ICS/LABAs) will shrink from almost half to 23 percent, targeted biologics will enter the market and start dominating the asthma space, accounting for 32 percent of total sales in 2023 from just 8.7 percent in 2013." "Despite the development of these biologics, a significant growth opportunity will persist for new patented products, especially lower-priced drugs with more convenient dosing, which will improve patient compliance," she added. ]]> <![CDATA[Jubilant raises Rs 2000 crore through NCDs]]> https://biospectrumindia.com/news/95/7364/jubilant-raises-rs-2000-crore-through-ncds.html https://biospectrumindia.com/news/95/7364/jubilant-raises-rs-2000-crore-through-ncds.html Fri, 12 Sep 2014 13:23:00 +0530 In a filing to Bombay Stock Exchange (BSE), Jubilant said that its shareholders have given approval to the board to offer or invite subscriptions for secured/unsecured redeemable non-convertible debentures, in one or more series or tranches, aggregating up to Rs 2000 crore on private placement basis or rights basis. ]]> <![CDATA[Baxter names its brand-new spinoff ]]> https://biospectrumindia.com/news/95/5069/baxter-names-its-brand-new-spinoff-.html https://biospectrumindia.com/news/95/5069/baxter-names-its-brand-new-spinoff-.html Fri, 12 Sep 2014 13:12:14 +0530 According to Baxter, Baxalta will witness approximately $6 billion in global revenues. The spinoff is expected to be launched in mid-2015 and publicly traded. Baxalta plans to trade on the New York Stock Exchange (NYSE) under the symbol BXLT. Baxter will continue trading on the NYSE under the symbol BAX. The corporate headquarters of both companies will be located in Northern Illinois, USA. ]]> <![CDATA[Venus signs deal with Mylan for meropenem in 3 European countries]]> https://biospectrumindia.com/news/95/4972/venus-signs-deal-with-mylan-for-meropenem-in-3-european-countries.html https://biospectrumindia.com/news/95/4972/venus-signs-deal-with-mylan-for-meropenem-in-3-european-countries.html Fri, 12 Sep 2014 13:05:56 +0530 The wholly owned subsidiary of Venus Remedies, based in Germany, Venus Pharma GmbH, has entered into a distribution-cum-outlicensing agreement with Mylan Laboratories for marketing its generic broad-spectrum antibiotic, meropenem, in three European countries. This deal with Mylan, the world's third largest generic drug manufacturer, will enable Venus Remedies to market meropenem in Denmark, Sweden, and Finland for a period of five years. Said Mr Ashutosh Jain, executive director-cum-chief operating officer (COO), Venus Pharma GmbH, Werne, Germany, "Under this non-exclusive marketing agreement, we will manufacture the drug at our Baddi facility, which recently got a renewed European Union Good Manufacturing Practices (GMP) certification, while the batch release and logistics will be handled by our Germany facility Venus Pharma GmbH. The addition of territories on the basis of strategic tie-ups with our existing partners has re-established the faith of our customers in our quality standards and timely deliveries. This joint venture will further help Venus Pharma GmbH and its collaborators in maintaining their market position to figure among the top five players with around 30 percent share in meropenem markets in countries like Germany, France, and UK." Venus already has a non-exclusive marketing tie-up with Mylan for the same product in France, where the drug has been successfully launched and is contributing to the company's top and bottom lines. Meropenem is a broad-spectrum antibiotic used in ICU infections as a last resort for the treatment of life-threatening infections. As per IMS Health, the market size for this product in Denmark, Sweden and Finland is approximately 12.54 million euros. It belongs to the carbapenem class of antibiotics and can be used effectively in both children and adults. Venus has successfully launched this drug in major European markets under its own brand name and through strategic alliance partners by way of tie-ups. Venus Remedies has secured more than 60 marketing authorizations for meropenem throughout the world from countries like the UK, France, Austria, Italy, Denmark, Finland, Ireland, Germany, Netherlands, Poland, Slovenia, Slovakia, Sweden, Portugal, Czech Republic, Cyprus, New Zealand, and Mexico, among others. The company recently got its first Australian marketing authorization for this product in a tie-up with Lupin. Venus is now all set to receive marketing approvals for meropenem from Switzerland and South Africa. "The top line of Venus Pharma GmbH, Germany has generated $15.6 million in the last one year, thereby becoming a profit-making unit of Venus Remedies. We are pleased to join hands with Mylan and expect Venus Pharma GmbH to achieve a significant increase in turnover in the coming quarters," said Mr Pawan Chaudhary, chairman and managing director (CMD), Venus Remedies Limited. The company is holding talks for more strategic tie-ups in regulated markets with multinational companies that are already operating in these territories. The facilities of Venus in India have a capacity of manufacturing 16 million units of meropenem per annum on single-shift basis. The company is currently utilising 50 percent of its capacity. Thus, it has sufficient excess capacity to meet growing market needs as it prepares for more marketing authorizations and widespread expansion of its marketing network across the globe. ]]> <![CDATA[Maharashtra Government to set up ebola screening centers ]]> https://biospectrumindia.com/news/95/4950/maharashtra-government-to-set-up-ebola-screening-centers-.html https://biospectrumindia.com/news/95/4950/maharashtra-government-to-set-up-ebola-screening-centers-.html Fri, 12 Sep 2014 11:20:00 +0530 The Mumbai High Court has given the Maharashtra state government 48 hours to set up ebola screening centers at Pune and Nagpur airports, where passengers from ebola-affected countries disembark. The decision came after activist Mr Ketan Tirodkar filed a public interest litigation alleging that India is not ready and equipped to tackle ebola. Given the urgency and seriousness of the situation, the court has asked the government to adopt adequate measures to screen passengers arriving from the affected African countries. Further, it said that the facilities should be on par with the ones available at Mumbai and Delhi airports. ]]> <![CDATA[What ails India's drug discovery research?]]> https://biospectrumindia.com/views/95/4793/what-ails-indias-drug-discovery-research.html https://biospectrumindia.com/views/95/4793/what-ails-indias-drug-discovery-research.html Thu, 11 Sep 2014 16:08:14 +0530 These scientists have been toiling hard in their laboratories to discover new drugs to cure many incurable diseases that are the scourge of human civilization. These centers were run by an MNC company, AstraZeneca and Indian drug major Piramal Life Sciences. Piramal Life Sciences' promoters were armed with nearly $2 billion in cash from the sale of their drug formulations business to Abbott Laboratories a few years ago. They made big announcements about using part of the cash towards the complex task of discovering new drugs instead of concentrating on more generics and became media darlings overnight. A few years later, and after the failure of an experimental cancer drug during the clinical trials, Pirmal Life Sciences has thrown in the towel "to protect the interests of shareholders." The 180 scientists at the Piramal center have been given two options: take voluntary retirement or move to other divisions of the company which focus on generics drugs business. New drug discovery is a long arduous journey that needs to be sustained over 10-15 years and burn about $1 billion to get one new product to the market. The second case of multinational AstraZeneca closing its iconic research center in the heart of Bangalore is more interesting. The center was a showpiece of AstraZenca's social concerns and tried to develop drugs against tuberculosis, a deadly disease that affects mostly developing countries. The Bangalore center was the first of the corporate research centers set up in Indiaas the country opened up to the world nearly three decades ago. The AstraZeneca center was where a large number of India's biotech entrepreneurs learnt skills of the trade. It did to biotech sector what the Texas Instruments achieved for the information technology sector by setting up the firstsoftware center and make Bangalore the Silicon Valley. In a twist of irony, the AstraZeneca's high tech biotech laboratories has been bought by an Indian software company Cognizant Solutions. Probably, the laboratories will be pulled down and thousands of cubicles to house software programmers will be set up on the campus. Another software giant, Kris Gopalakrishnan, co-founder of Infosys tried his best to salvage the AstraZeneca facility and use it to house a Brain Research center which he is supporting at the nearby Indian Institute of Science. Unfortunately, he was outbid by Cognizant in the battle between two Indian software companies. Meanwhile, both the Modi government at the center and the Siddaramaiah government in Karnataka watched helplessly unable to either acquire the AstraZeneca facility and convert it into a biotech incubator or use the leverage of government power to prevent the destruction of a global R&D facility. AstraZeneca had gifted a similar facility two years ago in Montreal, Canada, to the local government to run it as an incubation center instead of closing down. TheMNC has thumbed its nose at the state government as well as the center.Two other pharma companies- Dr Reddy's Laboratories and Glenmark Pharmaceuticals-are the few left in the drug discovery business and have been soldiering on despite the failure of some new discoveries during clinical trials. How long will the nascent Indian drug discovery flag keep flying is a moot question. ]]> <![CDATA[Mundipharma expands in Mexico]]> https://biospectrumindia.com/news/95/4798/mundipharma-expands-in-mexico.html https://biospectrumindia.com/news/95/4798/mundipharma-expands-in-mexico.html Thu, 11 Sep 2014 15:04:56 +0530 Mundipharma, a Uk-based pharma player with a base in India, has entered the Mexico market by opening its new office and intends to focus on pain management sector for analgesic and oncological treatment needs. Mundipharma opened offices in Brazil and Colombia in November 2013. "We are very excited to start formal activities in Mexico and bring Mundipharma's valuable expertise in pain relief to the over 28 million people estimated to suffer from chronic pain in the country today," said Mr Raman Singh, president, Mundipharma Asia-Pacific, Latin America, the Middle East and North Africa. As the economies of Latin American countries continue to evolve, chronic and non-communicable diseases such as cancer and diabetes have become the leading cause of illness in the region. Mr Singh stated "Mundipharma is a leader in the science of pain, and we are widely recognized worldwide for medical innovations in this area. Here in Mexico we are eager to start designing and contributing a portfolio of reliable and high-quality analgesic products to relieve the pain suffered by millions of people and their families." ]]> <![CDATA[Sweden launches a lifescience and healthcare platform]]> https://biospectrumindia.com/news/95/4460/sweden-launches-a-lifescience-and-healthcare-platform.html https://biospectrumindia.com/news/95/4460/sweden-launches-a-lifescience-and-healthcare-platform.html Thu, 11 Sep 2014 12:36:13 +0530 Sweden has announced the launch of a 'The Swedish LifeScience and Healthcare Platform' in India. It is being supported by the embassy of Sweden in India, the consulate general of Sweden and has leading Swedish healthcare companies on board. "Health is an important area where Sweden and India have growing interest and there is a mutual intention to strengthen bilateral ties and form strategic alliances," said ambassador of Sweden in India, Mr Harald Sandberg in a statement. He added, "India has its set of advantages. There is a lot to learn from India and I hope we will continue to exchange good practices, knowledge, and technology." It will further strengthen the Memorandum of Understanding (MoU) in healthcare that both the countries signed in 2009. Ms Anna Liberg, trade commissioner of Sweden to India said, "Sweden's history and results of inclusive care fit very well with India's ambition of care for many. Sweden can further contribute to India with its innovative, preventive, and continuous improvement focused healthcare system." It will provide opportunities in the areas of research, policy, innovations, and implementing best practices by both the countries. ]]> <![CDATA[Abcam appoints new CEO ]]> https://biospectrumindia.com/news/95/1464/abcam-appoints-new-ceo-.html https://biospectrumindia.com/news/95/1464/abcam-appoints-new-ceo-.html Wed, 10 Sep 2014 16:19:29 +0530 Mr Alan will succeed long-serving CEO and co-founder of Abcam, Mr Jonathan Milner, who will continue to play an active role in the company as deputy chairman, who is the company's largest shareholder. He takes on the role of CEO having spent the last year as chief marketing officer of Abcam, and he has served on the board since January 2014. In this role Mr Alan has the responsibility for the company's branding, product portfolio and online consumer offering. ]]> <![CDATA[Sartorius appoints new director]]> https://biospectrumindia.com/news/95/3007/sartorius-appoints-new-director.html https://biospectrumindia.com/news/95/3007/sartorius-appoints-new-director.html Wed, 10 Sep 2014 16:18:54 +0530 In this newly created position, Ms Monge will focus on sharpening SSB's profile as an integrated solution provider for the biopharmaceutical industry. Ms Monge brings in more than 20 years of experience in the biopharmaceutical manufacturing sector and has served, most recently, as the vice president of sales and marketing at the consultancy Biopharm Services. She is a committee member of the International Society for Pharmaceutical Engineering (ISPE) and one of the founders of the Global Disposable Community of Practice. She regularly authors articles for technical bioprocess journals, analyzing the impact of disposable technologies on biomanufacturing. ]]> <![CDATA[Roche's RA drug gets EU approval]]> https://biospectrumindia.com/news/95/4362/roches-ra-drug-gets-eu-approval.html https://biospectrumindia.com/news/95/4362/roches-ra-drug-gets-eu-approval.html Wed, 10 Sep 2014 11:16:15 +0530 The European Commission has approved Roche's RoActemra (tocilizumab) for use in patients with severe, active, and progressive rheumatoid arthritis (RA). It is to be used in patients, who have previously not been treated with methotrexate (MTX). "RoActemra is an effective biologic treatment for patients with early RA that may change the course of the disease and reduce the likelihood of disability," said Ms Sandra Horning, head of global product development and chief medical officer, Roche. She added, "As the first IL-6 receptor antagonist approved for early RA, RoActemra addresses the need for alternative treatment options to anti-tumor-necrosis-factor (anti-TNF) therapies in this debilitating condition." RoActemra is the first interleukin-6 (IL-6) receptor antagonist to be approved in Europe. ]]> <![CDATA[Nichi-In to halt Dendriatic cell cancer vaccine]]> https://biospectrumindia.com/news/95/4361/nichi-in-to-halt-dendriatic-cell-cancer-vaccine.html https://biospectrumindia.com/news/95/4361/nichi-in-to-halt-dendriatic-cell-cancer-vaccine.html Wed, 10 Sep 2014 11:13:35 +0530 Chennai-based Nichi-In Center for Regenerative Medicine has been by the DCGI, to stop selling the Dendriatic cell cancer vaccine for Dendriatic immunization therapy. The controller has also issued a safety alert against the use of dendriatic cells for the treatment of cancer. The company's facility was investigated by the DCGI, and it noted that the company collected blood from the patients, which after subsequent treatments like centrifugation and dilution was given to cancer patients as autologous immunotherapy. There was no approval for this process from competent authorities. It also observed that the ethics committee of the firm was not registered with CDSCO. The company has violated the D&C Act, 1940 and D&C Rules, 1945 which have a bearing on patient safety. "In view of violating rules, you are directed to stop the collection of blood from new patients for processing and administration of Natural Killer Cell and T cells with immediate effect and providing the same to patients till further orders in public interest," said the DCGI in its statement to the company. ]]> <![CDATA[Cipla enters Czech & Slovakian markets]]> https://biospectrumindia.com/news/95/5469/cipla-enters-czech-slovakian-markets.html https://biospectrumindia.com/news/95/5469/cipla-enters-czech-slovakian-markets.html Tue, 09 Sep 2014 15:54:01 +0530 Under the collaboration, Cipla will be driving its respiratory product portfolio in both Czech Republic and Slovakia through a Cipla owned sales force team, managed by Cipla commercial head. Mr Frank Pieters, head, Cipla Europe said, "We are excited to partner with S&D Pharma and believe that this collaboration will enable us to drive access in the Czech Republic and Slovakia across therapy areas in the coming years." S&D Pharma will physically distribute all products, including respiratory products, and this portfolio will increase over the next few years. Mr Daniel Straus, CEO, S&D Pharma said, "....Through this collaboration we have secured a competitive and varied product pipeline for the future and very much look forward to contributing to the future success of Cipla's respiratory range." ]]> <![CDATA[Venus inks pact with Mylan]]> https://biospectrumindia.com/news/95/5474/venus-inks-pact-with-mylan.html https://biospectrumindia.com/news/95/5474/venus-inks-pact-with-mylan.html Tue, 09 Sep 2014 15:38:13 +0530 Venus Remedies has announced that it has entered into distribution-cum-licensing agreement with Mylan for marketing its antibiotic, Meropenem, in three European countries Denmark, Sweden and Finland for a period of five years. "Under this non-exclusive marketing agreement, we will manufacture the drug at our Baddi facility, which recently has renewed its European Union Good Manufacturing Practices (GMP) certification, while the batch release and logistics will be handled by our Germany facility. This joint venture will further help Venus and its collaborators to figure among the top five players with around 30 percent share in Meropenem markets in Germany, France and UK," said Mr Ashutosh Jain, executive director-cum-chief operating Officer (COO), Venus Pharma GmbH, Germany. Venus already has a non-exclusive marketing tie-up with Mylan for the same product in France. Reportedly, the global market size of Meropenem is $1.5 billion. ]]> <![CDATA[200 bottles of Oxytocin seized in Hyderabad]]> https://biospectrumindia.com/news/95/5473/200-bottles-of-oxytocin-seized-in-hyderabad.html https://biospectrumindia.com/news/95/5473/200-bottles-of-oxytocin-seized-in-hyderabad.html Tue, 09 Sep 2014 15:20:05 +0530 The Andhra Pradesh drug control department has seized 200 bottles of the banned drug, Oxytocin in Hyderabad, as per reports. Each of the seized bottles contained 100ml of the drug. It is used to boost milk production in cattle, and also to increase the size of the fruits and vegetables. Both these activities are considered illegal in the country. The central government has banned this drug because of its various adverse side effects. "Under Schedule H of the drugs and cosmetic rules, 1954, the drug can be sold only as per the prescription of a registered medical practitioner. Other than this, any body found selling or buying the drug for other purposes, will be considered illegal and will receive a penal action as per law," said an official. The drug control department has become alert and is conducting frequent raids on suspects after the increased use of oxytocin in packed milk has come to light. Earlier, they arrested one person for administering the drug to cows. The officials are investigating the case in detail. ]]> <![CDATA[Ebola-A threat to national security: Obama]]> https://biospectrumindia.com/news/95/5467/ebola-a-threat-to-national-security-obama.html https://biospectrumindia.com/news/95/5467/ebola-a-threat-to-national-security-obama.html Tue, 09 Sep 2014 14:39:59 +0530 US President, Mr Barack Obama has warned member nations that Ebola could be a huge threat to the world, as the outbreak shows no healing signs and the number of cases are increasing with every passing day. He emphasized that US must lead the international community in arresting the outbreak. He added that the American military will be setting up isolation units and equipment in West Africa to provide security for public health workers flocking from around the world. The US President said, "There is no relief in sight, at least for the next few months." Though Mr Obama maintained that the risk of Ebola spreading to the US was very low, he warned that if the outbreak was not arrested soon, the virus could mutate and this would pose a serious threat to public health. Amid Ebola crisis, Sierra Leone has ordered a three day lock down starting on September 19, as part of an effort to stop the spread of Ebola, that has killed more than 2,000 people across West Africa. As a measure to stop the Ebola menace, the FDA had fast tracked the status of many experimental interventions that are under development for Ebola. Reports suggest that an experimental Ebola vaccine, similar to the GlaxoSmithKline's Ebola vaccine has proved effective for five weeks in protecting lab monkeys. ]]> <![CDATA[Merck's new drug fast-tracked by FDA]]> https://biospectrumindia.com/news/95/5333/mercks-new-drug-fast-tracked-by-fda.html https://biospectrumindia.com/news/95/5333/mercks-new-drug-fast-tracked-by-fda.html Tue, 09 Sep 2014 11:56:00 +0530 Merck's, relebactam an investigational beta-lactamase inhibitor, has been granted a Qualified Infectious Disease Product (QIDP) with fast-track status by the US regulator. The speedy assessment applies to intravenous use of relebactam for complicated urinary tract and intra-abdominal infections and hospital-acquired bacterial pneumonia/ventilator-associated bacterial pneumonia. In pre-clinical studies, it has demonstrated antibacterial activity against a broad range of gram-negative and beta-lactam resistant pathogens. QIDP designation offers certain incentives for the development of new antibiotics, including a five-year extension of data exclusivity and priority review of the New Drug Application (NDA) when filed. Mr Nicholas Kartsonis, head of infectious disease, Merck research laboratories, said, "The lack of new medicines to fight drug-resistant infections is a growing public health concern. We look forward to working with the FDA and other experts in infectious disease to study this medicine with the goal of bringing it to people suffering from potentially life-threatening resistant bacterial infections as quickly as possible." Relebactam is being evaluated in combination with imipenem/cilastatin in Phase II trials. Merck plans to initiate Phase III studies for the combination next year. ]]> <![CDATA[WHO's consultation on potential Ebola vaccines]]> https://biospectrumindia.com/news/95/5344/whos-consultation-on-potential-ebola-vaccines.html https://biospectrumindia.com/news/95/5344/whos-consultation-on-potential-ebola-vaccines.html Mon, 08 Sep 2014 14:55:46 +0530 According to WHO's press statement, after 2 days of discussion on potential Ebola therapies and vaccines, more than 150 participants, representing the fields of research and clinical investigation, ethics, legal, regulatory, financing, and data collection, identified several therapeutic and vaccine interventions that will be the focus of priority clinical evaluation. The following is the complete press statement from the WHO website: A number of candidate vaccines and therapies have been developed and tested in animal models and some have demonstrated promising results. Safety in humans is also unknown, raising the possibility of adverse side effects when administered. Use of some of these products is demanding and requires intravenous administration and infrastructure, such as cold chain, and facilities able to offer a good and safe standard of care. The experts determined: â€¢ There was consensus that the use of whole blood therapies and convalescent blood serums needs to be considered as a matter of priority. â€¢ Safety studies of the 2 most advanced vaccines identified - based on vesicular stomatitis virus (VSV-EBO) and chimpanzee adenovirus (ChAd-EBO) - are being initiated in the United States of America and will be started in Africa and Europe in mid-September. WHO will work with all the relevant stakeholders to accelerate their development and safe use in affected countries. If proven safe, a vaccine could be available in November 2014 for priority use in health-care workers. â€¢ In addition to blood therapies and candidate vaccines, the participants discussed the availability and evidence supporting the use of novel therapeutic drugs, including monoclonal antibodies, RNA-based drugs, and small antiviral molecules. They also considered the potential use of existing drugs approved for other diseases and conditions. Of the novel products discussed, some have shown great promise in monkey models and have been used in a few Ebola patients (although, in too few cases to permit any conclusion about efficacy). The existing supplies of all experimental medicines are limited. While many efforts are underway to accelerate production, supplies will not be sufficient for several months to come. The prospects of having augmented supplies of vaccines rapidly look slightly better. The participants cautioned that investigation of these interventions should not detract attention from the implementation of effective clinical care, rigorous infection prevention and control, careful contact tracing and follow-up, effective risk communication, and social mobilization, all of which are crucial for ending these outbreaks. The recipients of experimental interventions, locations of studies, and study design should be based on the aim to learn as much as we can as fast as we can without compromising patient care or health worker safety, with active participation of local scientists, and proper consultation with communities. This will require the following crucial elements: â€¢ Appropriate protocols must be rapidly developed for informed consent and safe useâ€¢ A mechanism for evaluating pre-clinical data should be put in place in order to recommend which interventions should be evaluated as a first priorityâ€¢ A platform must be established for transparent, real-time collection, and sharing of dataâ€¢ A safety monitoring board needs to be established to evaluate the data from all interventions All of these will require continued ethical oversight. ]]> <![CDATA[Cipla to acquire two plants for Rs 100 crore]]> https://biospectrumindia.com/news/95/5343/cipla-to-acquire-two-plants-for-rs-100-crore.html https://biospectrumindia.com/news/95/5343/cipla-to-acquire-two-plants-for-rs-100-crore.html Mon, 08 Sep 2014 14:01:09 +0530 Pharma giant Cipla has announced that it will acquire two manufacturing units from its contract manufacturer Okasa for an estimated Rs 100 crore. "A significant portion of the capacities of the two undertakings are dedicated for the manufacture of Cipla's products. Acquisition of the aforesaid undertakings is expected to yield operational synergies," the company said in a BSE filing. The Goa facility is owned by Okasa and the second manufacturing facility located at Satara (Maharashtra) is owned by Okasa Pharma. The acquisition will be carried out through the company's wholly owned subsidiary Medispray Laboratories. ]]> <![CDATA[Rotavirus vaccine from Hilleman shows promising results]]> https://biospectrumindia.com/news/95/5326/rotavirus-vaccine-from-hilleman-shows-promising-results.html https://biospectrumindia.com/news/95/5326/rotavirus-vaccine-from-hilleman-shows-promising-results.html Mon, 08 Sep 2014 11:41:44 +0530 Hilleman Laboratories, an equal joint-venture partnership between Merck & Co and the Wellcome Trust, announced a significant advancement in improving access to a life-saving rotavirus vaccine. Dr Davinder Gill, CEO, Hilleman Laboratories, who spoke at the 11th International Rotavirus Symposium held in New Delhi, mentioned, "We have developed thermostable formulations of pre-approved oral rotavirus vaccine that offer many months of stability in a dry powder form at temperatures that are ambient in the developing world. In addition, using frangible sealed pouches, we have designed an inexpensive single container-closure device that requires a very small footprint during distribution and delivery of our vaccine." The vaccine candidate will have optimized bulk antigen production processes combined with simple yet robust formulation and a scalable fill/finish to ensure a competitively priced vaccine. This will improve access in low-resource settings like India. Dr Gill later told BioSpectrum, "As our viral antigen and oral dosing are already pre-approved in liquid formulation, we aim to conduct rapid clinical trials to ensure accelerated approval of our vaccine. Our easy-to-administer delivery device offers an unique advantage both for improved affordability as well as increased access of the rotavirus vaccine." A recent study on Rotavirus in India by the Journal Vaccine estimates 11.4 million rotavirus-induced episodes in India annually. It further highlights that the burden of rotavirus disease in India is estimated to be 78,000 deaths annually of which 59,000 occur in the first two years of life. The rotavirus vaccines currently available rely on cold chain storage and result in higher distribution costs and inadequate supply to those in need. Hilleman Laboratories' initiative in developing a thermostable rotavirus vaccine will allow for greater temperature consistency and less reliance on exact storage timing and refrigeration. The company's initial focus is to heat stabilize the existing vaccine and bring it to the vaccine vial monitor (VVM) 30 levels and higher. This will determine the feasibility of applying innovative delivery technologies to an existing oral rotavirus vaccine to make it thermostable for further opportunities. ]]> <![CDATA[FICCI Heal 2014: Innovation enabling access to health]]> https://biospectrumindia.com/news/95/6572/ficci-heal-2014-innovation-enabling-access-to-health.html https://biospectrumindia.com/news/95/6572/ficci-heal-2014-innovation-enabling-access-to-health.html Mon, 08 Sep 2014 10:42:26 +0530 The annual healthcare conference 'FICCI Heal 2014' with the theme "Innovation Enabling Access", was held last week and focused on various opportunities and challenges to promote innovation, which can change the current paradigms and move towards better, efficient, and cheaper methods for accessible, affordable, and quality healthcare in India. FICCI also released two knowledge papers on 'Healthcare Innovations and Domestic Manufacturing' and 'Medical Value Travel in India'. The Federation of Indian Chambers of Commerce and Industry and Apollo Hospitals organized the event. Ms Sangita Reddy, chairperson, FICCI Health Services Committee and joint managing director, Apollo Hospitals Group, said, "Across industries, disruptive innovations have brought forth greater efficiencies, efficacy, economy and higher quality. The healthcare sector too needs to nurture such innovations as they are the need of the hour. Our nation, like most other across the world is standing at the precipice of a crisis created by the burden of disease and woefully inadequate healthcare infrastructure. Over the last four years, FICCI has been making sincere efforts to encourage health innovators, offering solutions to deliver care more effectively while improving access and quality from the grassroots level." Dr Didar Singh, secretary general, FICCI while supporting the central theme of the conference announced, "We propose to create virtual pooling of industry CSR funds by creating IISH (Indian Industry in Solidarity for Health) Kosh to channelize funds into priority areas in healthcare identified by the government. FICCI Health Services Committee is keen to work with the Health Ministry to develop a directory of healthcare activities based on the priorities of the government so that the CSR funds are channelized in the right direction to support National Health Assurance mandate of the government". In his Keynote Address, Mr Sunil Wadhwani, founding donor, Wadhwani Initiative for Sustainable Health shared that we should develop a national ecosystem for healthcare innovation, and create a computerised knowledge hub. He further shared that out of the total innovations in the country; we should select the best 300 to 400 innovations and raise 200 million dollars to promote them.In her Keynote Address, Dr Poonam Khetrapal Singh, regional director-SEARO, WHO emphasised the need for prevention rather than cure. She shared that in India there are two types of needs in the healthcare sector, basic needs and health innovation. She further shared the three areas in which India needs innovation, which are innovation in R&D, Health innovation, i.e. technical & devices and Household innovation. Expressing his views on the Medical Technology sector, Dr GSK Velu,co-chair, FICCI Health Services Committee, and founder and MD, Trivitron Group of Companies shared in his concluding remarks that the Medical Technology segment needs more focus and attention in India due to a very high import dependency and lack of large scale domestic manufacturing initiatives due to several challenges faced by local producers. Keeping in line with the new government's vision to make India Self Reliant with local manufacturing initiatives, FICCI has partnered with E&Y to bring this comprehensive knowledge paper to showcase the challenges faced by this Industry and FICCI will be happy to work with the Govt of India to create an ecosystem for making the Medical Technology segment self-reliant by facilitating continuous interactions with various stakeholders in this Industry." ]]> <![CDATA[India and Bangladesh to cooperate on traditional medicine]]> https://biospectrumindia.com/news/95/5304/india-and-bangladesh-to-cooperate-on-traditional-medicine.html https://biospectrumindia.com/news/95/5304/india-and-bangladesh-to-cooperate-on-traditional-medicine.html Mon, 08 Sep 2014 10:29:31 +0530 The union cabinet chaired by the Prime Minister, Mr Narendra Modi, last week gave its approval for the memorandum of understanding (MoU) for co-operation in the field of traditional systems of medicine and homoeopathy between India-Bangladesh. The signing of the proposed MoU will enhance bilateral cooperation between the two countries in the areas of traditional medicine and homoeopathy. This will be of immense importance to both countries considering their shared cultural heritage. The MoU shall also provide a structured frame-work for cooperation between the two countries for the promotion of Indian traditional systems of medicine and homeopathy in Bangladesh. There are no additional financial implications involved. However, financial resources necessary to conduct research, training courses, conferences or meetings will be met from the existing allocated budget and existing plan schemes of the Department of AYUSH. The total exports of Ayush products from India in 2012-13 was Rs 2167.57 crore. India's exports of herbal and Ayush products to Bangladesh for 2013-14 was Rs 31.85 crore. ]]> <![CDATA[FDA nod for a novel cancer drug by Merck]]> https://biospectrumindia.com/news/95/5245/fda-nod-for-a-novel-cancer-drug-by-merck.html https://biospectrumindia.com/news/95/5245/fda-nod-for-a-novel-cancer-drug-by-merck.html Sun, 07 Sep 2014 14:09:00 +0530 The US Food and Drug administration (US FDA) has approved Merck's Keytruda, used for patients with advanced melanoma. It belongs to a new class of cancer drugs that help unleash the body's immune system to fight tumors. Keytruda is the first drug, which has been approved, that inhibits the action of protein PD-1, or programmed death receptor 1. "This is really opening up a whole new avenue of effective therapies, previously not available. It allows us to see a time when we can treat many dreaded cancers without resorting to cytotoxic chemotherapy,"said Dr Louis M Weiner, director, Georgetown Lombardi Comprehensive cancer center, and a spokesman for the American Association for cancer research. The cost of treatment using this drug would be about $12,500 a month. Since the preliminary trials of the drug showed positive results, it was given accelerated approval by the FDA, allowing it to reach the market without going through the three typical phases of clinical trials needed to show that a drug can prolong lives. However, the company has to conduct two controlled clinical trials to verify that the drug can delay the progression of disease and extend life expectancy. ]]> <![CDATA[Study points out Asia's top medical tourism hubs]]> https://biospectrumindia.com/news/95/5243/study-points-out-asias-top-medical-tourism-hubs.html https://biospectrumindia.com/news/95/5243/study-points-out-asias-top-medical-tourism-hubs.html Sun, 07 Sep 2014 13:16:00 +0530 In a recent report released by KPMG and the Federation of Indian Chambers of Commerce and Industry (FICCI) - India, Thailand and Singapore have been named as the top three medical tourism destinations in Asia. The report titled, 'Medical Value Travel in India', pointed out that the top three countries together accounted for about 60 percent of the total Asian revenue in 2012. "Within Asia, India, Thailand and Singapore are the three countries that receive maximum medical tourists owing to low cost of treatment, quality healthcare infrastructure, and availability of highly-skilled doctors," the report said. The report further explained that the medical tourism segment has emerged as one of the largest in India, estimated at $78.6 billion as of 2012. The market in India is also poised to grow at an annual rate of 15 percent to reach about $158.2 billion by 2017. Apart from being the most cost-effective medical treatment locations, the other reasons why India is attracting patients are the high standards and expertise in cardiology, orthopaedics, nephrology, oncology and neuro surgery. The report further added that the country is also known for its alternative treatment options such as yoga and ayurveda. Further, other Asian countries too have introduced a number of marketing strategies to promote their nations by providing medical value travel. It added, the primary growth levers in this regard include low-priced treatment options, availability of variety of treatments, improved infrastructure in terms of healthcare facilities and attractive locations for spending time after treatment. The report that was conducted between July and August 2014 had public sector stakeholders and domestic company heads or CEOs of renowned hospitals participating in the survey. ]]> <![CDATA[An alternative to animals in clinical studies]]> https://biospectrumindia.com/news/95/5114/an-alternative-to-animals-in-clinical-studies.html https://biospectrumindia.com/news/95/5114/an-alternative-to-animals-in-clinical-studies.html Sat, 06 Sep 2014 10:05:00 +0530 Researchers are developing smartphone-sized microchips replicating human lungs, liver and other organs. These will mimic the human body's reaction to new drugs. They will also study the responses of the body to substances inhaled, absorbed in the gut or circulated through the bloodstream. They are branded as 'human on a chip' and developers hope to create 'human farms' to replace the controversial technique of live animal testing. The 'humans-on-a-chip' are comprised of several hundred different artificial organs. These organs work together to replicate an organic body functioning of a live human. These can be utilised to test everything from cosmetic products to the latest cancer drugs. The new system would save 90 million animals, which are being used every year as test subjects in clinical trials. Researchers claim that this technology could be available within three years. "If our system is approved by the regulators, then it will close down most of the animal-testing laboratories worldwide," said Mr Uwe Marx, a tissue engineer from Technische Universitat, Berlin and founder of TissUse, a firm developing the technology. This will also help in avoiding unforeseen effects, which are not detected during clinical trials on animals. ]]> <![CDATA[Jubilant receives 'Golden Peacock Business Excellence Award-2014']]> https://biospectrumindia.com/news/95/5068/jubilant-receives-golden-peacock-business-excellence-award-2014.html https://biospectrumindia.com/news/95/5068/jubilant-receives-golden-peacock-business-excellence-award-2014.html Fri, 05 Sep 2014 16:58:44 +0530 The presidential address at the awards ceremony was delivered by the governor of Tamil Nadu, Mr K Rosaiah, who also gave away the awards. The main theme of the summit was 'Business Excellence thru' Board Room Best Practices'. The prestigious award was presented to the Jubilant Gajraula team in the 'Chemicals and Pharmaceutical category' for showcasing a consistent journey of business excellence with a systematic approach for close to a decade. The selection was made from a total of 149 applications, of which 7 were declared winners and were awarded by the esteemed Jury under the Chairmanship of Justice (Dr) Arijit Pasayat, former Judge, Supreme Court of India and former chairman, Competition Appellate Tribunal of India and Authority for Advance Ruling (Customs, Central Excise and Service Tax). The awardees were honored in the presence of a distinguished gathering of business leaders, jurists, academics, environmentalists, economists, legislators, and policy makers.The summit was attended by dignitaries like former CVC Mr N Vittal, former CEC Mr T S Krishna Murthy, former senior officials of the Accountant General's office and speakers from Consulate offices representing countries such as Israel and Argentina and representatives from Singapore, UAE, Dubai, and France. Jubilant has been recognized with several awards and recognitions, which bear testimony to its commitment towards operational excellence, innovation, corporate governance, and social responsibility. ]]> <![CDATA[Suven granted patents for its neurodegenerative drug]]> https://biospectrumindia.com/news/95/5058/suven-granted-patents-for-its-neurodegenerative-drug.html https://biospectrumindia.com/news/95/5058/suven-granted-patents-for-its-neurodegenerative-drug.html Fri, 05 Sep 2014 12:05:58 +0530 South Korea, Canada and China, have individually granted Suven lifesciences, product patents for its neurodegenerative drug. The patents approved by South Korea and China are valid till 2029 while that by Canada is valid till 2030. "A product patent from South Korea, one from China and another from Canada corresponding to the new chemical entities for the treatment of disorders associated with neurodegenerative diseases," the company said in a BSE filing. "We are very pleased by the grant of these patents to Suven, for our pipeline of molecules in the CNS (central nervous system) arena that are being developed for cognitive disorders with high unmet medial need and with huge market potential globally," said company's CEO Mr Venkat Jasti. ]]> <![CDATA[Pharma giants explore IBM Watson's role in drug development]]> https://biospectrumindia.com/news/95/5044/pharma-giants-explore-ibm-watsons-role-in-drug-development.html https://biospectrumindia.com/news/95/5044/pharma-giants-explore-ibm-watsons-role-in-drug-development.html Fri, 05 Sep 2014 10:20:57 +0530 Leading lifesciences organizations are deploying Watson Discovery Advisor to advance discoveries in ongoing research projects, including Baylor College of Medicine, Johnson and Johnson and The New York Genome Center. Sanofi is exploring how working with Watson can speed up the discovery of alternate indications for existing drugs (drug re-purposing). Watson is able to understand and extract key information by reading millions of pages of scientific literature and then visualizes relationships between drugs and other potential diseases they could target while providing supporting evidence each step of the way. Drug safety and toxicity is a major driver of the high failure rate in clinical development and trials. Sanofi is exploring how Watson's ability to understand, extract and organize toxicological information can enable researchers to make better informed decisions with respect to candidate progression. Johnson & Johnson is collaborating with the IBM Watson Discovery Advisor team to teach Watson to read and understand scientific papers that detail clinical trial outcomes used to develop and evaluate medications and other treatments. This collaboration hopes to accelerate comparative effectiveness studies of drugs, which help doctors match a drug with the right set of patients to maximize effectiveness and minimize side effects. "We're entering an extraordinary age of data-driven discovery," said Mr Mike Rhodin, senior vice president, IBM Watson Group. "Today's announcement is a natural extension of Watson's cognitive computing capability. We're empowering researchers with a powerful tool which will help increase the impact of investments organizations make in R&D, leading to significant breakthroughs." IBM Watson will be supporting the analysis in New York Genome Center's clinical study to advance genomic medicine. The clinical study will initially focus on clinical application of genomics to help oncologists deliver DNA-based treatment for Glioblastoma. ]]> <![CDATA[Can Sanofi Pasteur's dengue vaccine candidate accomplish WHO's goal?]]> https://biospectrumindia.com/news/95/4970/can-sanofi-pasteurs-dengue-vaccine-candidate-accomplish-whos-goal.html https://biospectrumindia.com/news/95/4970/can-sanofi-pasteurs-dengue-vaccine-candidate-accomplish-whos-goal.html Fri, 05 Sep 2014 10:00:00 +0530 A dengue vaccine is said to represent a major advance for the control of the disease and could be an important tool for reaching the WHO's goal of reducing dengue mortality by at least 50 percent, and morbidity by at least 25 percent by 2020. As an advancement towards this goal, Sanofi Pasteur, the vaccines division of Sanofi announced that the final landmark phase III efficacy study of its dengue vaccine candidate in Latin America successfully achieved its primary clinical endpoint. The results also showed in the study population an efficacy against dengue haemorrhagic fever (DHF), the severe form of dengue1, which is consistent with the results released from Sanofi's phase III dengue study in Asia. "For the first time ever, after 20 years of research and industrial commitment, dengue is set to become a vaccine preventable disease," said Mr Olivier Charmeil, president and CEO, Sanofi Pasteur. "The data generated from our comprehensive research and clinical program involving 40,000 children, adolescents and adults from 15 countries, will be submitted to the health authorities in countries where dengue is a public health priority."Lastly, the results suggest better protection in case of prior exposure to dengue. ]]> <![CDATA[AZ, Redx to target genetic drivers of tumor growth]]> https://biospectrumindia.com/news/95/5041/az-redx-to-target-genetic-drivers-of-tumor-growth.html https://biospectrumindia.com/news/95/5041/az-redx-to-target-genetic-drivers-of-tumor-growth.html Fri, 05 Sep 2014 10:00:00 +0530 The research will complement AstraZeneca's strategic approach focused on genetic drivers of cancer and mechanisms of resistance to established and novel cancer therapies. The research collaboration will involve Redx Pharma scientists working with AstraZeneca's oncology innovative medicines group to accelerate the drug discovery process. Redx Pharma will use its early stage drug discovery capabilities to identify novel leads whose further development will be supported by AstraZeneca's extensive knowledge of the area and strong oncology expertise. Under the terms of the agreement, Redx Pharma will receive an undisclosed upfront payment. In addition, Redx Pharma is potentially eligible for significant development and commercial milestones, as well as tiered royalties as the program progresses. AstraZeneca will have the sole rights to further develop and commercialize any programme resulting from the collaboration to add to its portfolio of cancer medicines. Ms Susan Galbraith, head, oncology innovative medicines unit, AstraZeneca, said, "Collaboration and scientific exchange are at the heart of AstraZeneca's innovation-led strategy. This partnership is based on our own early stage oncology research focused on the genetic drivers of cancer and allows us to build on our combined drug discovery expertise. The co-location of our scientists will facilitate our collaboration. This agreement supports our strategic objectives of accelerating discovery and improving the quality and choice of candidate compounds for our early pipeline." As part of the collaboration, AstraZeneca and Redx scientists will work together at Alderley Park, as well as at Redx's Liverpool facility where the project will be based. Mr Neil Murray, chief executive, Redx Pharma, said, ".....This deal represents a significant development for our oncology business-another major transaction and the first time we've had an opportunity to work with the oncology innovative medicines unit at AstraZeneca. The project is a good fit for both parties and builds on Redx's strong track record in rapidly developing novel drugs in cancer." ]]> <![CDATA['Rotavirus vaccine can reduce infant mortality']]> https://biospectrumindia.com/news/95/5057/rotavirus-vaccine-can-reduce-infant-mortality.html https://biospectrumindia.com/news/95/5057/rotavirus-vaccine-can-reduce-infant-mortality.html Thu, 04 Sep 2014 14:28:00 +0530 Rotavirus, a leading cause of severe and fatal diarrhea in children under five years of age worldwide, has been a major cause of worry across the globe. Killing between a quarter and a half-a million children each year, rotavirus significantly impedes achieving the Millenium Development Goal 4: reduce child mortality. The Eleventh International Rotavirus Symposium that began from September 03, 2014 in New Delhi, has drawn various stakeholders to deliberate upon the means to tackle the disease. As per Dr Mathuram Santosham, chair of ROTA Council and professor of International Health and Pediatrics at Johns Hopkins University in Baltimore, Maryland, United States. "We cannot reduce death and suffering from rotavirus as well as its significant economic toll without vaccines. Greater prioritization of rotavirus vaccines will protect children and avoid substantial health costs to families and health care systems. India, which has a heavy rotavirus burden but is home to a promising new vaccine, is the perfect setting to evaluate the current scientific evidence on rotavirus vaccines for informed decision-making." In 2014, India announced the introduction of a new vaccine, shown to reduce severe diarrhea, caused by the rotavirus, by 56 percent, in the national immunization program. Rotavirus is estimated to cause more than 78,000 deaths, 800,000 hospitalizations and three million outpatient visits each year in India. If used in all GAVI-eligible countries, rotavirus vaccines could also prevent an estimated 180,000 deaths and avert six million clinic and hospital visits each year, saving $68 million in annual treatment costs. Yet, despite the WHO's recommendation for all countries to introduce rotavirus vaccines in their national immunization programs, only 35 percent of countries worldwide (69) have done so. Of those countries, only one is in Asia. "Every child deserves the chance to live a long, healthy, productive life," said Dr Gagandeep Kang, head of the Wellcome Trust Research Laboratory at the Christian Medical College in Vellore, Tamil Nadu, India. "When rotavirus vaccines are part of a comprehensive strategy including oral rehydration solution (ORS), breastfeeding, good nutrition, and improved water, sanitation, and hygiene, we can make this vision a reality." Globally, diarrhea is one of the most common causes of hospitalizations of children. According to the World Health Organization (WHO), more than one-third (36 percent) of all hospitalizations for severe diarrhea are caused by rotavirus. In some settings around the world, hospitalizations are a tremendous financial burden to already impoverished families and strain health systems. However, rotavirus vaccines could cut hospitalizations of children under five by four to eight percent and substantially improve child health and survival. Overall, 95 percent of rotavirus deaths occur in developing countries like Asia and Africa. In Asia, rotavirus kills approximately 188,000 children under five each year and in Africa, rotavirus kills 232,000 children. However, children everywhere are at risk of infection. ]]> <![CDATA[Health minister: govt will push indigenous research]]> https://biospectrumindia.com/news/95/5024/health-minister-govt-will-push-indigenous-research.html https://biospectrumindia.com/news/95/5024/health-minister-govt-will-push-indigenous-research.html Thu, 04 Sep 2014 14:11:00 +0530 Speaking at the 11th International Rotavirus Symposium on September 03, Dr Harsh Vardhan, Union health minister stated that Rotavirus is the primary cause of moderate to severe diarrhoea morbidity and mortality for children less than five years of age in India. "By including it under UIP along with Japanese Encephalitis, Rubella, and Polio, the Narendra Modi government has sent a sharp signal of its commitment to the aam admi," he mentioned. "Earlier Rotavirus vaccines were expensive and beyond the reach of ordinary Indians. We are losing 52 children per 1000 live births every year. On top of that Rotavirus Diarrhoea snatches at least 1 lakh. This government did not lose time in introducing the vaccine in UIP. The plan of action on its deployment has also been put in place," he said in the presence of Mr Roger Glass, director of Fogarty International Center, United States, Dr Mathuram Santosham, ROTA Council, John Hopkins University, Dr K Vijay Raghavan, secretary, Department of Biotechnology, and Mr Lov Verma, union health secretary. The Rotavirus vaccine will be introduced starting 2015, as an additional dose along with the first, second, and third doses of DPT in the UIP. There is a proposal to establish an expert committee to assess the progress in few states and union territories on the basis of the disease burden and vaccine availability. Dr Vardhan stated further, "Meeting the Millennium Development Goals is not an end in itself. After assuming office, our government has launched a systematic study to make the public health care system user-friendly and accountable. Doctors have been told to work ahead of the deadline for meeting infant and maternal mortality targets." Lauding the efforts of the scientific community, Dr Harsh Vardhan said indigenous research will be given a big fillip under the new government. "The government of Narendra Modi does not take decisions arbitrarily or on the basis of populism, but relies only on evidence. Anything that is decided by the scientific community as good for the protection of the lives of mothers and children will be dovetailed into the public health policy," he stated. ]]> <![CDATA[Merck Serono pumps in â‚¬80 million to erect China plant ]]> https://biospectrumindia.com/news/95/5008/merck-serono-pumps-in-80-million-to-erect-china-plant-.html https://biospectrumindia.com/news/95/5008/merck-serono-pumps-in-80-million-to-erect-china-plant-.html Thu, 04 Sep 2014 12:05:00 +0530 The plant represents an investment of â‚¬80 million, and will be Merck's largest manufacturing facility outside of Europe. The new facility will cover an area of 40,000 square meters, with a possible 20,000 square meters extension. The construction of the site is scheduled to be completed in 2016, with commercial production starting in 2017. The new facility, which will be the group's second-largest pharmaceutical manufacturing facility worldwide, and will focus on the bulk production and packaging of Glucophage, Concor and Euthyrox, which are Merck Serono's leading brands for the treatment of diabetes, cardiovascular diseases and thyroid disorders, respectively. "We have steadfastly aligned our focus and strategy with the Chinese government's efforts to increase patient access to quality care throughout the country," said Mr BelÃ©n Garijo, president and CEO, Merck Serono. "Today, we are focused on localizing production to better cater to the demands of Chinese doctors and patients. At the same time, we are localizing R&D to further build a differentiated portfolio of medicines in China, aimed at serving patient needs for general as well as specialized care. We are also creating alliances and partnerships with local partners in in every part of our operations." ]]> <![CDATA[PAU enters into agreement with CPRI to produce potato breeder seeds]]> https://biospectrumindia.com/news/95/6066/pau-enters-into-agreement-with-cpri-to-produce-potato-breeder-seeds.html https://biospectrumindia.com/news/95/6066/pau-enters-into-agreement-with-cpri-to-produce-potato-breeder-seeds.html Thu, 04 Sep 2014 10:16:00 +0530 Saving the seeds of varieties particularly well-adapted to environmental conditions is important for enhancing production. In India, when the Central Potato Research Institute, Shimla was established in 1949, there were no seed certification standards for potato. The institute, therefore started a systematic seed production program. Recently, CPRI and PAU signed an agreement for breeder seed production of potato by the university. The MoU was signed by Dr Bir Pal Singh, director, CPRI Shimla and Dr B S Dhillon, vice chancellor, PAU Ludhiana. The main objective of this MoU is to augment the production of breeder seed of important varieties of CPRI by PAU Ludhiana on their seed farm, with the technical collaboration of CPRI Shimla. On this occasion, Dr N K Krishna Kumar, DDG (Horticultural Science) ICAR and Mr Suresh Kumar, financial commissioner (Development), Government of Punjab were present. ]]> <![CDATA[Novo Nordisk exits R&D in inflammatory disorders]]> https://biospectrumindia.com/news/95/6778/novo-nordisk-exits-rd-in-inflammatory-disorders.html https://biospectrumindia.com/news/95/6778/novo-nordisk-exits-rd-in-inflammatory-disorders.html Wed, 03 Sep 2014 16:36:55 +0530 On September 2, 2014, Novo Nordisk officially announced its decision to discontinue all its R&D activities within inflammatory disorders. The company said that it will increase its focus and efforts more within diabetes prevention and treatment, obesity and diabetes complications. ]]> <![CDATA[USFDA accepts Actavis' ANDA filing]]> https://biospectrumindia.com/news/95/4982/usfda-accepts-actavis-anda-filing.html https://biospectrumindia.com/news/95/4982/usfda-accepts-actavis-anda-filing.html Wed, 03 Sep 2014 15:26:00 +0530 "The NDA filing of Eluxadoline marks an important step forward for this potential first-in-class treatment, which demonstrates our commitment to helping patients suffering from this debilitating condition," said Mr Paul Covington, MD, senior vice president, clinical operations and development, Furiex Pharmaceuticals, a subsidiary of Actavis. "We are pleased that the FDA has granted Eluxadoline a priority review, setting the stage for us to bring this potential new treatment option to patients promptly." The NDA submission for Eluxadoline is based on the results of two Phase III clinical studies that met their primary endpoints. The 12-week efficacy portion of the studies demonstrated significant superiority over placebo in the composite endpoint of the simultaneous improvement in both pain and diarrhea at both 75mg and 100mg doses. Eluxadoline was well-tolerated and the adverse events (reported in greater than 5 percent of Eluxadoline-treated patients and at an incidence greater than placebo) consisted of constipation [7.4 percent (75 mg) and 8.6 percent (100 mg) vs 2.5 percent placebo], nausea [8.1 percent (75mg) and 7.5 percent (100mg) vs 5.1 percent placebo] and abdominal pain [4.1 percent (75mg) and 5.0 percent (100mg) vs 2.7 percent placebo]. The studies consisted of approximately 2,500 patients. Pursuant to pre-NDA discussions with FDA, Actavis is planning to submit an amendment to the NDA with additional data from a study that was ongoing at the time of submission. As a result, it is expected that this will extend the Prescription Drug User Fee Act (PDUFA) date by three months. The company expects the PDUFA date in Q2 2015. "There continues to be an unmet need for treatments to manage the chronic symptoms experienced by patients with IBS-D. If approved, Eluxadoline could be a promising option for patients who continue to suffer from these symptoms," said Mr Anthony Lembo, MD, attending physician, Beth Israel Deaconess Medical Center and associate professor of Medicine, Harvard Medical School. ]]> <![CDATA[DBT launches national initiative to identify biomarkers for preterm births]]> https://biospectrumindia.com/news/95/4978/dbt-launches-national-initiative-to-identify-biomarkers-for-preterm-births.html https://biospectrumindia.com/news/95/4978/dbt-launches-national-initiative-to-identify-biomarkers-for-preterm-births.html Wed, 03 Sep 2014 15:11:32 +0530 After a series of national and international consultations, the Department of Biotechnology (DBT), Ministry of Science and Technology, Government of India has launched a major national program to identify the correlates, causes, and predictive biomarkers of preterm birth under its Grand Challenge Program. The first-phase of the initiative has been allocated Rs 48.85 crore for 5 years. A birth that takes place before the mother has been pregnant for at least 37 weeks construes a preterm birth. In India, among the total 27 million babies born annually, 3.6 million babies are born preterm, and over 300,000 of these preterm babies die each year because of associated complications. India, with its highest number of PTBs and the highest number of preterm deaths worldwide, contributes 25 percent of the overall global preterm related deaths. The effects of PTB extend beyond early infancy with substantial long-term consequences in late childhood and adult life. The objective of DBT's program is to collect scientific information on pregnancy that may lead to a preterm birth, a pregnancy has to be identified early, followed up through the duration of the pregnancy during which clinical and life-style information must be collected. Biological changes taking place during this period must also be assayed by collecting blood and other biological materials from the pregnant woman. Further, because differences in biological responses and life-style factors are enormous among pregnant women, information needs to be collected on a large cohort. The overall long term goals are to stratify women early in pregnancy or before conception into various levels of risk of PTB, identify simple and better prediction tools that will recognize the optimal time of prediction and clinical intervention, develop additional strategies to identify presence of unusual or novel microbes that could serve as biomarkers; identify focused remedies targeting one or more mechanistic pathways (e.g. infection, inflammation, hormonal), and apply currently available interventions (tocolytic agents) based on better understanding of biological mechanisms. The scientific success of this program is bound to have a major ripple-effect on the discovery of preventive therapies. It will contribute significantly towards reduction in infant and maternal mortality rates. The PTB program is establishing a hospital-based cohort of pregnant women starting from the first trimester, each of whom will be followed up until delivery. The cohort is being established in a district hospital in Gurgaon, Haryana. Because of the multifactorial nature of a preterm birth, scientific expertise from multiple domains of clinical, biological, and statistical sciences are required. Therefore, a cross-disciplinary platform is being used to bridge expertise from disparate fields, such as, pediatrics, gynecology, infectious disease biology, epidemiology, microbiology, immunology, cellular and molecular biology, genetics, statistics and computational & systems biology. The data and biospecimens being collected in this study are of paramount value, not only for the present time but also for a long period into the future. Therefore, it is critical to collect and store data and biospecimens under globally-accepted quality assurance protocols. These protocols have been established with guidance from the World Health Organisation. Data storage and sharing will be under the guidelines being established by the Global Alliance for Genomics and Health (GA4GH), of which DBT is a partner. DBT is also a member of the Global Coalition to Advance Preterm birth Research (G-CAPR), that has a primary mission to identify and advance priority research through expanded networks, communications, and collaborations among organizations to fund the research needed to reduce preterm birth at the international level. The Program is being monitored by a Steering Committee represented by eminent national and international experts in important domain areas who are responsible for strategic guidance. A Program Management Committee has been formed to address matters related to scientific, technical and financial aspects on regular basis and report to the Steering Committee. ]]> <![CDATA[Modi Govt's 100 days: Dr Jitendra Singh announces establishing â€œNational Cancer Institute']]> https://biospectrumindia.com/news/95/4979/modi-govts-100-days-dr-jitendra-singh-announces-establishing-national-cancer-institute.html https://biospectrumindia.com/news/95/4979/modi-govts-100-days-dr-jitendra-singh-announces-establishing-national-cancer-institute.html Wed, 03 Sep 2014 15:02:54 +0530 Coinciding with the completion of 100 days of the Narendra Modi-led government, Dr Jitendra Singh, Union minister of state (Independent Charge) for science and technology formally announced the decision to collaborate on behalf of the Department of Biotechnology (DBT) with All India Institute of Medical Sciences (AIIMS), New Delhi for establishing a National Cancer Institute at Jhajjar in Haryana. The project is to come up at the cost of Rs 2,000 crore and the DBT will offer major inputs for cancer research and care. Addressing a heavily attended press conference, Dr Jitendra Singh, announced the setting up of a Joint Research Advisory Body, which, he claimed, would be possibly the best in the world. The minister said this joint initiative between the health ministry and AIIMS is a part of the ministry's endeavour to use Science and Technology as a medium of service to the society and to promote new technologies at affordable and cost effective prices. "The Biotechnology department under him will help medical researchers design clinical trials and collaborate for joint development and evaluation of vaccines, biomarkers, therapeutics, etc.," stated Dr Singh. In addition, the minister also announced the setting up of a major new institute under the Department of Biotechnology for "Pre-term Birth" Research Clinical applications. This will be his department's major support to medical science considering the fact that India, with its highest number of pre-term births and the highest number of pre-term deaths worldwide, contributes 25 percent to the global pre-term related deaths, he added. Dr K Vijay Raghavan, secretary of science and technology and biotechnology, was also present at the conference. ]]> <![CDATA[Cancer research gets due priority, DBT & AIIMS sign agreement]]> https://biospectrumindia.com/news/95/4955/cancer-research-gets-due-priority-dbt-aiims-sign-agreement.html https://biospectrumindia.com/news/95/4955/cancer-research-gets-due-priority-dbt-aiims-sign-agreement.html Wed, 03 Sep 2014 13:07:42 +0530 At a time when cancer cases in India as per reports, would cross about 7 lakh by 2015, the government has decided to tackle the disease head on. In that context, the Department of Biotechnology (DBT) under the ministry of science and technology, and the All India Institute of Medical Sciences, under Ministry of Health and Family Welfare, through it upcoming National Cancer Institute at Jhajjar have signed a Memorandum of Understanding (MoU) on 22nd August, 2014 for furtherance of Cancer Research, taking into cognizance that the cancer disease burden is fast reaching pandemic proportions in India. The initiative was been formally announced on September 02, 2014. While DBT funds research using modern tools of biology, AIIMS is a tertiary-care hospital cum research center. Both recognize the importance of collaborative and complimentary research so as to bring about an improvement in public awareness on likely causes of cancer, prevention strategies, early-detection, and improved therapeutic interventions to improve the quality of life and the survival rate. Their efforts will specially focus on cancers unique to India such as Gall-bladder, oral and cervical and Naso-pharyngeal cancer, and others with a high disease burden. DBT has been supporting basic, clinical, and molecular epidemiological cancer research through its various schemes for the past 20 years. It promoted the development of diagnostics for cervical cancer, indigenous cervical cancer vaccines, immuno-modulation clinical trials, and biomarker discovery. Schemes such as SBIRI and BIRAC which support industry are proactive in funding bio-similar therapeutics, monoclonal antibodies etc., to bring down the cost. This helps the cancer treatment become less expensive for individuals and the social system. AIIMS, on the other hand is developing a National Cancer Institute at its upcoming Jhajjar campus where the focus is also on cancer research, in addition to patient care and management. The project, to be developed at a cost of about Rs 2,000 crore as sanctioned by the Ministry of Health in the coming three and a half years. It is expected to be a big step in research for cancer in the country and would play a significant role in cancer treatment. So far, India has about 28 Regional Cancer Centers that mainly treat patients. However, research has not been a priority. Through this MoU, there is a plan to set up a joint Research Advisory Board to identify areas of research: immediate, medium and long-term planning, evolve a consensus mechanism to harmonize administrative and financial processes and approvals (evaluation, funding, and monitoring) through mutual discussion, develop a policy perspective including economic analysis and forecasting for technology with potential for use in public health especially in cancer related areas, Scientific Research collaborations in the area of Cancer Biology to promote development of new affordable technologies, introduction of the available technologies in the system and provide support for the diffusion of technologies into the social system. To fulfill this, joint efforts will be made for research and its translation to public health in India; with specific focus on cancers unique to India, jointly design clinical trials, collaborate for joint development and evaluation of vaccines, diagnostics, biomarkers, therapeutics etc., in translational research with strong networking and co-ordination. Training of man-power by offering joint clinical fellowships; building capacity in the country within medical schools or outside the system; opening the facilities and infrastructure to scientists identified under the jointly agreed programs; jointly support competence building through short-term training programs in GLP, GCP, quality control, IPR, regulation, and clinical trial skills that are critical for development of new technologies, co-creating a state-of-the art Bio-bank with well annotated specimens. The two premier institutions will also jointly support and forge partnership with industry for the development and evaluation of products for public health through a Public Private Partnership within the framework of their rules and regulations. ]]> <![CDATA[Novartis' most promising heart drug]]> https://biospectrumindia.com/news/95/4835/novartis-most-promising-heart-drug.html https://biospectrumindia.com/news/95/4835/novartis-most-promising-heart-drug.html Wed, 03 Sep 2014 10:54:02 +0530 The drug, LCZ696, could decrease by 20 percent, the effects of cardiovascular disorders and risk of hospitalisation due to chronic heart failure (CHF). This drug was tested on more than 8,400 patients in 47 countries. They received either LCZ696 or enalapril. Reduction in risk for cardiovascular death and hospitalisation was about 20 percent. About 32 patients were treated with LCZ696 to prevent death from cardiovascular disorder. The drug was tolerated and did not pose any risk. Taking LCZ696, twice-a-day, reduced the risk of mortality by 16 percent and showed no unmanageable side effects. Dr Milton Packer, a professor of clinical sciences at the University of Texas Southwestern Medical Center in Dallas, said, "The results are extraordinarily powerful and compelling; they are destined to change management of patients with CHF for years to come." "To say we are excited is an understatement. We are absolutely thrilled. Given the survival advantage of LCZ696 over available drugs it would be difficult to understand why physicians would continue to use traditional ACE inhibitors or angiotensin receptor blockers for the treatment of heart failure," he added. LCZ696 has already been granted fast-track status by the US Food and Drug Administration (USFDA) and the company will apply to the European submission (EU) early next year. The research is published in the New England Journal of Medicine and was also presented at the European Society of Cardiology Congress in Barcelona, Spain. ]]> <![CDATA[Ebola could afflict another 20,000: WHO]]> https://biospectrumindia.com/news/95/5430/ebola-could-afflict-another-20000-who.html https://biospectrumindia.com/news/95/5430/ebola-could-afflict-another-20000-who.html Wed, 03 Sep 2014 10:49:00 +0530 The World Health Organization said the the current Ebola outbreak shows no healing signs with new cases and deaths being registered with every passing day. The health agency estimated that the current Ebola outbreak could afflict more 20,000 people, almost seven times the current number of reported cases, before it could be effectively curtailed. Mr Daniel Epstein, WHO spokesperson, expressed concern over the number of Ebola cases being reported. He stated that many cases went unreported. Mr Epstein mentioned that the outbreak has intensified with many people from the cities too, falling prey to the lethal virus. Mr Epstein however assured that the containment protocols were working as number of people dying from the disease had reduced to 52 percent. He stated that fear of death in treatment centers and lack of awareness has discouraged people from seeking medical assistance. Meanwhile, experts analyzing the virus in scores of victims have said that the virus has mutated repeatedly throughout the outbreak, severely hindering containment and treatment efforts. ]]> <![CDATA[India, Japan to find a remedy for sickle cell anemia]]> https://biospectrumindia.com/news/95/4822/india-japan-to-find-a-remedy-for-sickle-cell-anemia.html https://biospectrumindia.com/news/95/4822/india-japan-to-find-a-remedy-for-sickle-cell-anemia.html Wed, 03 Sep 2014 10:00:00 +0530 During his recent visit to Japan, Prime Minister Mr Narendra Modi discussed cooperation with Kyoto University, Japan, to combat sickle cell anemia, prevalent in many parts of India. An external affairs spokesperson, Mr Syed Akbaruddin said that Tokyo and India are looking at an agreement to find a remedy for the genetic disorder, which causes the red blood cells in the blood to take a sickle shape and contains a defective hemoglobin gene. Mr Modi discussed medical interventions for the disorder with Nobel Prize winner for Medicine, Mr Shinya Yamanka, the director for Kyoto University. Mr Modi said, "I want to integrate both cultural and scientific heritage to make India a developed country." Health officials opine that the prospect of cooperation on sickle cell anemia is a step in the right direction towards combating the disease. In India, the disease is most commonly found among tribal groups in parts of Gujarat, Orissa, Maharashtra, Madhya Pradesh and Chattisgarh. Mr Yamanka had received a Nobel Prize for his ground breaking research on pluripotent stem cells. He said that currently there were no Indian researchers at his institute, the Centre for IPS Cell Research and Application. He further stated that he would like to invite Indian scientists to collaborate and conduct research at the institute to promote global wellness. ]]> <![CDATA[Global Nanotechnology market to touch $3 trillion by 2018]]> https://biospectrumindia.com/news/95/6740/global-nanotechnology-market-to-touch-3-trillion-by-2018.html https://biospectrumindia.com/news/95/6740/global-nanotechnology-market-to-touch-3-trillion-by-2018.html Tue, 02 Sep 2014 13:23:00 +0530 The curtain raiser for the conference was held on September 1, 2014, in Bangalore, in the presence of dignitaries including Prof. CNR Rao, chairman, Karnataka's Vision Group on Nanotechnology; Shri SR Patil, minister for Planning and Statistics, IT, BT, Science & Technology; Shri Srivatsa Krishna, IAS, secretary to the Government, Department of IT, BT and S&T, Government of Karnataka; and Prof. AK Sood, department of physics, IISc. By 2018, the commercial Nanotechnology market is expected to reach $3 trillion, with India having a market chunk of 20-25 percent, revealed Shri Srivatsa. Themed 'Nano Horizons' this year, this international event will serve as one stage confluence for the government, scientists, policy makers, research institutes, students, entrepreneurs, industry and academia, offering a plethora of explorative opportunities in advancing Nanotechnology and Nanotechnology. On the occasion, Prof. CNR Rao said, "In the US, Japan, and China, there is a lot of investment happening in the area of Nanotechnology research. Through this technology, many new materials have come out in the last few years. Actually two years ago, this field didn't exist much. Now it has become a major area of research. There are new developments which are promising, and a number of possibilities are seen in device technology and applications including Spintronics." When asked about Nanobiotechnology fairing in India, he told BioSpectrum, "Nanobiotechnology is doing very well in the country. Major researches has come out of NCBS proving to be very outstanding matching international standards." Shri Srivatsa emphasized that no part of human life will remain untouched by Nanotechnology and Nanotechnology. "The Ebola virus vaccine is being developed using nano particles. Researchers are turning to Nanotechnology for finding a cure for this dreaded disease," he opined. Prof. AK Sood told BioSpectrum that the new nano park is expected to be unveiled in the next 3 to 4 months. "The initial investment that has gone into this has been about Rs 50-60 crore, and it will add up further phase-by -phase," he told. The top Indian institutions in this area are located in Bangalore - IISc Bangalore being one of them, along with National Center for Biological Sciences (NCBS) and Jawaharlal Nehru Center for Advanced Scientific Research (JNCASR). Talking about Bangalore India Nano, Shri SR Patil said, "In my opinion, this is a historical event. Karnataka is the second largest technology cluster on the planet. In the future, Nanotechnology is expected to have impact on almost every field possible including biotechnology, agriculture, food technology, medicine, healthcare and environment, electronics, renewable energy, IT and material science." India's first premier nano institute is emerging in the outskirts of Bangalore. Under the guidance of Prof. CNR Rao, this institute will be developed into a hub for Nanotechnology in the country. "We are also planning a nano park with an incubation center to promote Nanotechnology industry in the state. In the future, Bangalore will be called as the 'Nano-capital' of India," he added. Last year, the 6th edition of Bangalore India Nano witnessed more than 600 delegates, with the participation of 245 organizations from 12 countries along with 500 graduate students, and 45 top experts in the industry. This year, the event will include product & technology tradeshow, pre-conference tutorials, keynote talks by eminent guests, poster session, Nano for the Young, Research Industry Collaboration Hub (RICH), and InterlinX, which is a partnering tool and networking reception. The main highlight in this years' edition is the tutorials on nano fabrication, scanning probe microscopy and transnational new medicine. More than 500 participants are expected from 13 to 14 countries to be present at the event. Also, Prof. CNR Rao Bangalore INDIA NANO Science Award and Bangalore INDIA NANO Innovation Award will be presented at the event for distinguished personalities with achievements in Nanotechnology. ]]> <![CDATA[Mylan files ANDA for MS drug]]> https://biospectrumindia.com/news/95/4702/mylan-files-anda-for-ms-drug.html https://biospectrumindia.com/news/95/4702/mylan-files-anda-for-ms-drug.html Tue, 02 Sep 2014 13:18:07 +0530 Mylan, the US-based global generic drug maker has filled a ANDA with the regulatory body for its drug, Copaxone. "Our marketing partner in the USA, Mylan has filed an abbreviated new drug application (ANDA) for a three-times-a-week generic Copaxone (glatiramer acetate injection) and has been accepted by the US Food and Drug Administration (US FDA)," said Natco pharma, partner of Mylan in a filling. The ANDA is for the product in the strength of 40 mg/mL, it added. "Mylan believes it is one of the first companies to have filed a substantially complete ANDA containing a Paragraph IV certification for this product and expects to be eligible for 180 days of market exclusivity in the US upon final FDA approval," said the company. According to IMS health, Copaxone 40 mg/mL had US sales $411.5 million till June 2014. ]]> <![CDATA[816 passengers being tracked for Ebola Virus ]]> https://biospectrumindia.com/news/95/4804/816-passengers-being-tracked-for-ebola-virus-.html https://biospectrumindia.com/news/95/4804/816-passengers-being-tracked-for-ebola-virus-.html Tue, 02 Sep 2014 11:00:27 +0530 As per the information bulletin issued by the health ministry, the construction group, Afcons and International SOS have brought back 113 passengers (including 02 Nepalese Nationals) from Liberia to India. 96 passengers landed in Mumbai and another 17 in Delhi. The passengers who landed in Delhi were also taken to Mumbai by Afcons. They have all travelled to their respective destinations. State Governments have been provided with the details. The IDSP is tracking these passengers. Reports have been received from the State IDSP units of 18 of the 20 States about 80 passengers being monitored. One passenger, who is being tracked and monitored in West Bengal has confirmed to be having Malaria (P falciparum). The ministry has reported that during the last 24 hours, 181 passengers from the affected countries have arrived at the airports of Mumbai (71), Delhi (44), Chennai (22), Bangalore (26), Kochi (4), Trivandrum (7), Hyderabad (4), and Kolkata (3). Six high risk (suspect cases) have been admitted on 1st September 2014 to the quarantine facility at the Delhi Airport. About 15,009 passengers arriving at International airports have been screened since the process started on August 10, 2014 (as on August 27, 2014). The Control Room in the ministry of health and family welfare has received 706 calls since its inception on August 09, 2014 and only 05 calls were received in the past 24 hours. Most of the callers have sought information on signs and symptoms of the disease and travel related risk of acquiring the infection. ]]> <![CDATA[Govt promises transparency in organ donation ]]> https://biospectrumindia.com/news/95/6135/govt-promises-transparency-in-organ-donation-.html https://biospectrumindia.com/news/95/6135/govt-promises-transparency-in-organ-donation-.html Tue, 02 Sep 2014 10:23:30 +0530 Dr Harsh Vardhan, Union health minister, has called for total, Information Technology-guided transparency in the interface between the organ donor and recipient when the National Organ and Tissue Transplantation Organization (NOTTO) becomes operational. After a visit to the Safdarjung Hospital, where NOTTO is housed on two floors of the Pathology Building, the minister said, "There will be no VIP quotas and no recommendations from officers will be entertained. Every life is worth protecting and the spirit of the movement is not to be mocked." A general waiting list will be maintained. Once a brain-stem dead patient's consent is available, a state-of-the-art retrieval, matching and transplantation operation will swing into action. A patient who registered his name for the waiting list will be given a number which will not change even if he admits himself to another hospital later. NOTTO's web portal will be fully operational, and in the first phase will cover kidney cases within the next 10 days. The second phase is expected to cover some more body parts and will be operationalized in six months. The Rs 149 crore National Organ and Tissue Transplantation Program will have NOTTO at its apex. There would also be Regional Organ and Tissue Transplantation Organizations at Kolkata, Chennai, Mumbai, Chandigarh, and Guwahati. Six state level organizations are also planned at the new All India Institutes of Medical Sciences at Patna, Jodhpur, Rishikesh, Raipur, Bhubaneswar, and Bhopal. "I am an organ donor myself and am committed to making this a nation-wide movement.. Why can't we be like Spain where every brain-stem death case leads, by default, to the body being donated for saving lives? I think we should educate our people more on this necessity," the minister said. As a consequence, the health minister has ordered ministry officials to plan a series of programs involving students and social organizations. Essay writing competitions and social events are being planned to raise awareness. Dr Harsh Vardhan spent a long time inspecting NOTTO's networking office, training center and the facilities for preserving skin, cornea, bones, and heart valves at the National Bio Material Center which is a part of the organization. A call center is being set up, which will be the point of contact between donors and people on the waiting list in real time. Incidentally, the minister had launched the Asian Organ Donor Registry at AIIMS, New Delhi on the occasion of World Organ Donation day (August 6) and on August 26 had released a poster for awareness generation organized by the Indian Medical Association. ]]> <![CDATA[Piramal Mumbai R&D unit shut: What next?]]> https://biospectrumindia.com/news/95/4401/piramal-mumbai-rd-unit-shut-what-next.html https://biospectrumindia.com/news/95/4401/piramal-mumbai-rd-unit-shut-what-next.html Mon, 01 Sep 2014 16:59:00 +0530 Recently the lifesciences industry heard Piramal's public vocalization announcing the shutdown of its Mumbai R&D unit. Though the company now intends to abandon its R&D in new drug discoveries, in an exclusive interview with BioSpectrum, Dr Swati A Piramal, vice chairperson, Piramal Enterprises, said that the company is actually not shutting its Mumbai R&D unit, but rather reorganizing and reallocating its research in discovery research. "We are just reorganizing people to work in later stages of the drug development rather than new discoveries. We already have an adequate number of discoveries in our pipeline and need to focus our capital on molecules nearer the end-of-development or companion-products, to products which have received approval," added Dr Swati. The company will now concentrate on its existing portfolio of eight molecules. Piramal's lead molecule Neuraceq (florbetaben) recently received approval from the USFDA and European Medicines Agency. Dr Swati revealed that the company has an imaging pipeline in areas of cancer, cardiology, and neuroscience. "Other new products are being developed in anaesthesia. We have signed a joint venture in the development and manufacturing of fluoro-chemicals with Navin Fluorine, an Arvind Mafatlal Group," she commented. Currently, the company has 800 research personnel globally. In India they are located in Hyderabad, Ahmedabad, Pithampur, and Chennai. Internationally, they are in the USA, the UK, Scotland, and Germany. According to Dr Swati, the 200 personnel who are on the spot as a result of the shutdown are being offered with an option to work from Piramal's other locations. The fate of the employees will be known in a month, according to the company, once the voluntary employee separation scheme is complete. When asked about the status of the current lifesciences R&D in the country, Dr Swati concluded by saying, "I think the regulatory bottlenecks are slowing research and innovation. I hope it will change with the new government." ]]> <![CDATA[Ebola: Indians in Liberia donate $200,000 ]]> https://biospectrumindia.com/news/95/4708/ebola-indians-in-liberia-donate-200000-.html https://biospectrumindia.com/news/95/4708/ebola-indians-in-liberia-donate-200000-.html Mon, 01 Sep 2014 16:32:00 +0530 Nearly 2,000 Indians residing in Liberia have congregated to help the African health ministry fight the Ebola outbreak, that has claimed 1,552 lives so far. The Liberian President has acknowledged the efforts of Indians in spreading awareness about Ebola in the interiors of West Africa. With the help of their honorary consultant general Mr Upjit Singh Sachdeva, Indians in Liberia have donated two ambulances and other valuable items worth around $200,000 to the national anti-Ebola campaign. Liberian president Ms Ellen Johnson Sirleaf who received the donation, thanked and praised Indians for standing by Liberia in its difficult times. Mr Sachdeva commended Ms Sirleaf for her extraordinary leadership and effective response to the outbreak. He stated, "The response by the international community to combat the disease is very encouraging." He further added that the outbreak has hampered intra-sub regional trade on which Liberia has largely been dependent upon for essential food items. At the event, Mr Sachdeva added that as a part of the Liberian society, the Association of Indian Community in Liberia, sees itself as an important stakeholder and is honor-bound to contribute to the fight to eliminate the disease. He said that though the outbreak has had a severe effect on the economy, the Indian community has advised all its members not to exploit this situation by unnecessarily hiking prices. ]]> <![CDATA['Bioethanol production has to be encouraged']]> https://biospectrumindia.com/news/95/4707/bioethanol-production-has-to-be-encouraged.html https://biospectrumindia.com/news/95/4707/bioethanol-production-has-to-be-encouraged.html Mon, 01 Sep 2014 16:22:50 +0530 "I often dream of the times when people from urban areas would like to shift back to villages for building their bunglows and not vice versa. And also when the Indian farmers would be the richest among entreprenuers," stated Mr Nitin Gadkari, Union transport and rural development minister at a recently held awards show in New Delhi. Emphasizing on the role of adopting technology and promoting entreprenuership, Mr Gadkari, who is known as a serial entreprenuer, explained, "Pilot projects led by farmers must be encouraged to find ways to improve irrigation facilities. The minister minced no words while saying that the fertilizer prices have gone up umpteen number of times, but that the crop prices have grown merely by an average of 2 percent. Talking about the creation of a bank of innovation led by Dr R A Mashelkar, former director general, CSIR and Dr APJ Abdul Kalam, former president of India, he said that the government will ensure that the best ideas do not go waste. Further stressing upon the need to produce biogas and ethanol at local levels, Mr Gadkari mentioned that the conversion of bioethanol from molases resulting from baggase can in longer run present itself as a viable alternative fuel. Giving an example, he talked about the running of buses on bioethanol efficiently. "We have to find ways to lessen our dependence on gas cylinders and create options for gas pipelines," mentioned the minister. "Conversion of waste into wealth should be the top priority. And that is possible by innovation, research, cooperation, and coordination. We have to utilze biotechnology and moderrn techniques to boost growth especially when the GDP has come down significantly,"opined the former chief of the ruling Bharatiya Janta Party. The agriculture minister, Mr Radha Mohan Singh who was also present at the agriculture awards show of Crystal Group on August, 27, remarked that agriculture was sidelined in all the previous budgets. "This is for the first time that it has received its due attention in the budget besides the dairy technology which has been allocated Rs 500 crore," he said. ]]> <![CDATA[Ignored so far, rare genetic disorders continue to face neglect]]> https://biospectrumindia.com/news/95/5783/ignored-so-far-rare-genetic-disorders-continue-to-face-neglect.html https://biospectrumindia.com/news/95/5783/ignored-so-far-rare-genetic-disorders-continue-to-face-neglect.html Mon, 01 Sep 2014 16:16:00 +0530 Recently in New Delhi, experts from across the globe came together for the first South Asia Meet on Lysosomal Storage Disorders (LSD) which result becasue of the missing or dysfunctional enzymes from the lysosome of a cell. LSDs are a group of around 45 rare genetic disorders, found in about one in every 5,000 live births in the world. Most LSDs are managed through disease-specific supportive care measures in the absence of any treatment or cure. While most patients in India remain unaware of the fact, the prominent doctors informed the audience that 6 out of 45 rare and debilitating genetic diseases are now completly treatable with enzyme replacement therapy (ERT). These treatable rare diseases include Gaucher Type I, Fabry's disease, Pompe disease, MPS I (Hurler disease), MPS II (Hunter disease), and MPS VI (Maroteaux-Lamy syndrome). Present at the event held on August 30, was Dr V M Katoch, secretary, Department of Health Research, and director general, ICMR, who was the chief guest. Dr Katoch accepted that India, due to its competing priorities in healthcare has neglected the rare diseases. "Their cause is currently being promoted by few individuals in the medical community, but we need a proper and permanent organizational structure and network in the government and healthcare system to identify these diseases, conduct research, put together documentation and draft a practical plan to tackle rare diseases. There is also a need for collaboration with SAARC countries because people in the region have the same genetic makeup and dietary habits. Not many medical companies have moved into the space of rare diseases in India because of miniscule volumes and lack of incentives from the Government. This has to be rectified. Another challenge is the lack of diagnostic tools to identify most of the rare diseases. We need a structured approach to the problem to make a difference. It is a difficult task but can be done in the next few years," explained Dr Katoch. Currently, there are 8 to 10 centers of excellence in the country for the management and treatment of LSDs, and 6 to 8 centers have diagnostic capabilities. In Delhi-NCR, two hospitals - AIIMS and Sir Ganga Ram Hospital - provide free counseling and treatment to 30 patients of LSDs, who are registered with LSDSS, a non-profit organization that works for the cause of patients with rare diseases. Genzyme, a part of Sanofi, has been running an initiative called the "India Charitable Access Program" under which it provides free treatment to around 100 children suffering from LSDs. As per Dr I C Verma, director, Centre of Medical Genetics, Sir Ganga Ram Hospital, and patron, Society for Indian Academy of Medical Genetics, "Enzyme replacement therapy (ERT) is critical to improve the quality of life for patients suffering from Lysosomal Storage Disorders and is a new hope to these patients. Without treatment, there is a progressive accumulation of partially degraded compounds which stealthily leads to multi-organ dysfunction." The South Asia Meet on Lysosomal Storage Disorders has been organized by the Indian Society for Inborn Errors of Metabolism (ISiEM), Society for Indian Academy of Medical Genetics (SIAMG) along with the Genetics Chapter of the Indian Academy of Pediatricians (IAP) and supported by Genzyme. Expert clinicians, practitioners, academicians, and researchers from across India and South Asia participated in the two-day event (August 30-31, 2014) to discuss latest advancements in the diagnosis and treatment of LSDs. Prominent speakers at the meet included Dr Shubha R Phadke, professor and head, Department of Medical Genetics, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow; Dr R Premlatha, director, Indira Gandhi Institute of Child Health, Bangalore; Dr Jayesh Seth, director, Institute of Human Genetics, Ahmedabad; Dr Pramod K Mistry, professor of Medicine, Yale University; and Dr Alberto Ortiz, professor of Medicine, University Autonoma of Madrid (UAM), Spain. Dr AP Dubey, professor and head, Department of Pediatrics, Maulana Azad Medical College, said, "Misdiagnosis and delay in treatment can play havoc in the lives of these patients. Lifelong treatment with ERT allows them to lead a near normal and productive life, but unfortunately most of them cannot afford it as the treatment is very expensive and beyond the means of almost everyone." Experts at the meet agreed that the major roadblock in tacking LSDs is the high cost of treatment with biological drugs. These drugs are different from chemical drugs and entail considerable research and safety benchmarks. Their R&D and manufacturing costs need to be recovered from the patient population, which is miniscule compared to that of common diseases like diabetes and cancer. Moreover, all the medicines of rare diseases are imported into India, adding to the costs. Ms Meryl Sarah, a Delhi-based patient of Pompe disease, brought cheer to the audience when she narrated her story. She said that initially she faced a lot of hardship because of misdiagnosis but is happy today. With access to ERT, Ms Sarah is able to lead an active and normal life and shows no visible symptoms of the disease. "I am lucky to have access to this life-saving treatment. I am optimistic about the future as my condition is much better now. I hope all patients of these rare diseases get access to timely ERT treatment to lead normal lives," she added. ]]> <![CDATA[Crystal National Agri Awards for farmers and agriculture scientists]]> https://biospectrumindia.com/news/95/8100/crystal-national-agri-awards-for-farmers-and-agriculture-scientists.html https://biospectrumindia.com/news/95/8100/crystal-national-agri-awards-for-farmers-and-agriculture-scientists.html Mon, 01 Sep 2014 15:54:53 +0530 Responding to the Prime Minister, Narendra Modi's independence day speech in which he had asked scientists to bring innovative farm practices from lab to land and ensure per drop more crop, one of country's leading agri business companies Crystal Crops Protection, announced a first of its kind awards to recognize contributions of farmers and scientists to Indian agriculture. Present at the awards ceremony to honour winner farmers and scientists from across the country, were union agriculture minister, Mr Radha Mohan Singh and Union transport and rural devlopment minister, Mr Nitin Gadkari gave away the Crystal National Agri Awards on August 27. The awards were organized by Krishi Anusandhan and Kisan Vikas Foundation (KAVF). It is "aimed to identify and felicitate all those whose contributions have made a difference to the agriculture eco-system." "Farmers are the backbone of the national economy. I am happy that this unique initiative is designed to recognize innovations and initiative of farmers. The winners will inspire many others," said the agriculture minister at the ceremony. "Our government is committed to ensure soil cards for all farmers in the next three years and irrigation in all fields in the next five years," he said. Crystal Group has taken the lead to promote Indian farmers and agriculture scientists for their innovative and exemplary work in increasing agriculture production and bringing in innovation on the farm and in labs, informed Mr NK Aggarwal, chairman, Crystal Group. An Agri Vision Document with some key prescriptions to address challenges in the agriculture sector too was unveiled on this occasion. Awards were given away to 12 progressive farmers for using innovative practices; six scientists for outstanding contribution to agri research; two special jury awards and one NGO which has been working innovatively among farming communities. The jury members for the awards comprised respected public sector scientists including Dr CD Mayee, former chairman, Agricultural Services Recruitment Board, ICAR, Govt of India; Dr Jay G Varshney, former director, Directorate of Weed Science Research, ICAR, Govt of India, Jabalpur; and Dr T Haque, former chairman, Commission for Agricultural Costs and Prices, Govt of India. "Indian agriculture is among the biggest and the most vibrant in the world. It sustains the lives of billions of Indians besides providing livelihood to millions of farmers. Yet the interest in this sector, and the attention to it, has been dwindling and this is one effort to bring the glory back to this sector," added Mr Aggarwal. Mr Aggarwal also announced the company's support to build 100 toilets for the girl child across Bihar, UP, Odisha, Jharkhand, Maharshtra through KAVF and donated Rs 21 lakh towards this. "Inspired by the call of the Prime Minister and in keeping with our commitment to contributing meaningfully to the communities we work with, we decided to contribute to this very novel work," informed the chairman of Crystal group, which has a strong presence in crop protection and agri equipment. ]]> <![CDATA["Local manufacturing can turn medical tech into $50 bn industry"]]> https://biospectrumindia.com/news/95/7081/local-manufacturing-can-turn-medical-tech-into-50-bn-industry.html https://biospectrumindia.com/news/95/7081/local-manufacturing-can-turn-medical-tech-into-50-bn-industry.html Mon, 01 Sep 2014 15:13:53 +0530 Speaking at the 7th medical technology conference organised by the Medical Technology Division of Confederation of Indian Industry (CII) in New Delhi on August 20, 2014, Mr Kant said "Therefore it is essential that the sector exploit the cost advantage, if it wants to compete with China in the global market." Mr Kant, along with other union health secretary Mr Lov Verma and Dr K Vijay Raghavan, secretary, Department of Biotechnology (DBT) and leading captains of medical technology industry were present at the event to unveil the 'Vision Document - 2025', an extensive report on the Medical Technology sector jointly prepared by CII and Boston Consulting Group. As per the Vision Document, getting things right could lead to a $30 billion domestic market opportunity as well as setting up the right manufacturing capabilities could spur an additional $20 billion manufacturing opportunity for the Indian medical technology space. The CII director general, Mr Chandrajit Banerjee, said, "Due to its pleasure and potential, CII is happy to acknowledge the Medical Technology Sector as a sunrise sector" Expanding on the theme of effective governance, Mr Pavan Choudary, chairman, Medical Technology Division of the CII and managing director, Vygon India, said "Classification of medical devices as drugs, burdens the process of investment with fiscal policy obstacles and regulatory hurdles. It impacts FDI, technology transfer, local investment, manufacturing, operations, innovation and exports." "The Vision Document - 2025 highlights the need for a dedicated, separate and globally harmonised regulation for medical devices," added Mr Himanshu Baid, co-chairman, CII Medical Equipment Division and managing director, Poly Medicure. Mr Rahul Guha, partner and director, Boston Consulting Group (BCG) India remarked that there was lack of investment, lack of regulation, less priority of the government and this was therefore a vicious circle. "The innovations and the licenses are something that unfortunately are not going in tandem with each other," Mr Guha said. According to the CII-BCG report, global medical technology market is expected to be $600 billion plus by 2025 and that India can capture 10 percent of that share if provided with adequate support and policy guidance.To build up a roadmap for India to reach its full potential in medical technology, CII and BCG assembled a think tank of 40 plus industry participants to brainstorm and determine the key levers required to be able to unlock the true potential of India. BCG held a set of workshops across Mumbai and Delhi to discuss and debate the right focus areas and develop a roadmap to unlock this potential. Among the key recommendations proposed by the CII-BCG Report are - â€¢ Need for a separate regulatory act for Medical Technologyâ€¢ Need for manufacturing incentives (for example-tax support, low cost funding to spur investments)â€¢ "Single-window" clearance to ease the regulatory burden for the industryâ€¢ Creation of 'National Innovation Policy' to reward results in innovationâ€¢ Need for world-class Manufacturing Infrastructureâ€¢ Set up Collaborative Partnershipsâ€¢ Invest in Capability Development and Training by setting up Centers of Excellence for medical technology training â€¢ Global task force to promote India as a manufacturing and R&D hub globallyâ€¢ Create industry sponsored programs between local and global industry on joint collaboration projectsâ€¢ Industry - Academia Collaboration. To facilitate curriculum adaptation as well as cross-pollination of knowledge between students of Medical Technology and Business Management. ]]> <![CDATA[Australian PM's visit to India: Biotech remains on top agenda]]> https://biospectrumindia.com/news/95/6030/australian-pms-visit-to-india-biotech-remains-on-top-agenda.html https://biospectrumindia.com/news/95/6030/australian-pms-visit-to-india-biotech-remains-on-top-agenda.html Mon, 01 Sep 2014 12:34:00 +0530 The Australian prime minister, Mr Tony Abbott is set to visit India on September 4, 2014. Ahead of the visit, the Australian High Commissioner in New Delhi, Mr Patrick Suckling called on Dr Jitendra Singh, Union minister of state for science and technology, to discuss different issues likely to come up during the visit. Dr Jitendr Singh told the high commissioner, he was glad that some major announcements are scheduled during the Australian Prime Minister's visit which include the Australian Government's decision to extend the "Australia-India Strategic Research Fund" (AISRF) for four years from 2015-16 primarily for work in the field of Biotechnology as also Science and Technology. Expressing satisfaction, the science and technology minister said that this initiative will underline Australia's commitment to bilateral partnership between the two countries and will further strengthen to grow scientific and innovation collaboration between the two nations. This may further pave the way for participation in several other joint projects as well, he added. Dr Singh informed that so far, 46 joint projects and 9 bilateral workshops covering areas of aquaculture, biofuels, biomedical devises, bioremediation, transgenic crops, vaccines, stem cell research etc., have been jointly supported by the two countries. Dr Jitendra Singh disclosed that the researchers from All India Institute of Medical Sciences (AIIMS), New Delhi and the Australian National Trauma Research Institute are already working together under the "Australia-India Trauma Systems Collaboration Program" and in this connection, the Prime Minister of Australia, Mr Tony Abbot is also scheduled to visit the Truama Centre at AIIMS, New Delhi during his New Delhi visit next week. ]]> <![CDATA[Misplaced outrage over decision to halt GM crop trials]]> https://biospectrumindia.com/views/95/6557/misplaced-outrage-over-decision-to-halt-gm-crop-trials.html https://biospectrumindia.com/views/95/6557/misplaced-outrage-over-decision-to-halt-gm-crop-trials.html Sun, 31 Aug 2014 15:23:00 +0530 The reported assurance of Environment Minister, Mr Prakash Javadekar, to anti-GM activitists who called on him to keep in abeyance the regulatory approval for the field trials of 15 crops, has predictably created a storm across the country. The mainstream media has accused the Narendra Modi government of pandering to the whims of organizations like the Swadesi Jagaran Manch (SJM) and Bharatiya Kisan Sangh (BKS) in preventing cultivation of new genetically modified (GM) crops in the country. Both these organizations are loose affiliates of the ruling Bharatiya Janata Party (BJP) which is the dominant constituent of the ruling NDA coalition. But most of these die-hard opponents of the government decision, to put on hold the regulatory approval taken by the Genetic Engineering Approval Committee (GEAC) on July 18, 2014, are missing the point. The Modi government would have actually betrayed the trust of the people if it allowed introduction of new GM crops. For the BJP manifesto in 2014 had clearly stated that "GM foods will not be allowed without full scientific evaluation of their long-term impact on soil production and biological impact on consumers." Obviously, the manifesto had taken inputs from various affiliated organizations and so the party could not have gone against its stated policy after assuming power. Of the 15 approvals for confined trials granted by GEAC, four are food crops -- mustard, brinjal, rice and chickpea. And the GEAC has also allowed the import of GM soybean oil by three MNCs -- Monsanto, Bayer BioScience and BASF. A leading columnist Mr Swaminathan Anklesaria Aiyer has argued in The Economic Times that the government should approve GM crops on the occasion of the 100th Birth Anniversary of Dr Norman Borlaug this year. Dr Borlaug supplied the hybrid seed technologies to India in 1960s that led to the Green Revolution. What is the real situation in India? The country has not banned GM crops. The first GM crop, Bt cotton, was allowed 11 years ago and is a runaway success. Farmers have accepted it. The actual debate is about the use of GM food crops. The country needs a rational debate on the costs and benefits of growing GM crops. It must be remembered that the hybrid technology was developed by publicly funded laboratories under the United Nations system. It was further adopted to Indian conditions by the large network of government agricultural universities and institutions. The benefits accrued to the society. On the other hand, the GM technology is a near monopoly of US based multinational, Monsanto Corporation. On every packet of GM seeds sold in the country and in 26 other countries where it is allowed, Monsanto earns a handsome 'technology fee'. Most of the opposition to GM technology in India and most of Europe, even the USA, comes from a vast coalition of civil society groups who are vehemently opposed to the emergence of Monsanto as the new Czar of global food markets. It is safe to assume that Monsanto is the red rag that pulls all GM opponents in the direction and not really the technology. Modi government should allow experimental trials of GM crops in India to study its impact but it should be done by Indian government scientists and not by private companies. The public trust in our agricultural research system is still very high and it should be used to the fullest to resolve the contentious GM crops issue at the earliest. ]]> <![CDATA[Love thy neighbor, reduce heart ailments: Study]]> https://biospectrumindia.com/news/95/4800/love-thy-neighbor-reduce-heart-ailments-study.html https://biospectrumindia.com/news/95/4800/love-thy-neighbor-reduce-heart-ailments-study.html Sun, 31 Aug 2014 14:28:00 +0530 Living in a community filled with love and harmony can contribute to the health of your heart, claim scientists. A study published in the Journal of Epidemiology and Community Health indicate that having good neighbors and feeling connected to others in the local community could significantly reduce the risks of heart attacks. The research conducted by the University of Michigan on 5,276 people above 50 years of age, elaborated that those with the highest neighborly scores could reduce their risk of a heart attack by up to 70 percent. During the four year monitoring period, 148 of the 5,276 participants (66 women and 82 men) had a heart attack. In the study published in the Journal Epidemiology and Community Health, the participants, whose average age was 70, were asked to describe their neighborhood. The participants were asked to award points about their neighborhood on the seven point scale. The survey included questions like how much they felt a part of the community, whether there would be lots of people to help them if they were in trouble, how much they trusted people in their area and how friendly their neighbors were. The team found that for every point they had awarded out of seven, an individual had a 17 percent reduced heart attack risk over the four-year study period. ]]> <![CDATA[Are your heart, health, and job interlinked?]]> https://biospectrumindia.com/news/95/4614/are-your-heart-health-and-job-interlinked.html https://biospectrumindia.com/news/95/4614/are-your-heart-health-and-job-interlinked.html Sun, 31 Aug 2014 18:27:00 +0530 According to a new research conducted by the US National Institute for Occupational Safety and Health, people in certain job profiles are at a higher risk of suffering from heart attacks and strokes than others. In a study published in the Morbidity and Mortality Weekly Report, researchers indicated that people who work in the service industry or have a blue-collar job are more prone to heart attacks and strokes. Lead researcher, Dr Sara Luckhaupt explained, "Workplace factors that increase risk include job stress, exposure to air pollution like dust, smoke and noise." People working in a few select sectors like administrative, support, waste management, remediation services, accommodation and food services, live science reporting suffered the most attacks, closely followed by people working in the wholesale trade. Figures indicate that already, 2.9 percent of people engaged in wholesale trade in the US have suffered heart attacks and strokes. The findings also revealed that people working in finance and insurance had the lowest risk of heart ailments. Researchers also highlighted that job insecurity was the common cause of stress leading to cardiovascular problems. Dr Gregg Foofaraw, a professor of cardiology at the University of California, Los Angeles, said, "As heart disease and stroke remain the leading causes of death in men and women across the globe, prevention strategies and workplace health programs are essential." He added that employers must take proactive measures to promote health and wellness among its staff and utilize effective interventions to prevent heart attacks and strokes. ]]> <![CDATA[A molecular gel with diverse applications ]]> https://biospectrumindia.com/news/95/4461/a-molecular-gel-with-diverse-applications-.html https://biospectrumindia.com/news/95/4461/a-molecular-gel-with-diverse-applications-.html Sun, 31 Aug 2014 10:05:00 +0530 Under the guidance of professors from IIT-Madras and Pondicherry University, a team of students have developed a new type of gel molecule. It is made from inexpensive and renewable raw materials, and is called glucose triazole hydrogenated cardanol conjugate (GTHCC). This gel, the research for which was published in the Royal Society of Chemistry's journal "RSC Advances", could be useful in pharmacology, cosmetics, electronics, pollution control, and also for lubrication. Pondicherry University professor Mr H Surya Prakash Rao and his team prepared the gel from glucose and a product obtained from liquidizing cashew nut shell, a by-product of the cashew industry while IIT-M professor Mr Ashok K Mishra and his team discovered the gelling properties of the molecule. Mr Rao said that the challenge had always been in discovering stcturally simple molecular gels extracted from inexpensive and renewable raw materials using convenient procedures. The hydrogel was stable under acidic as well as basic conditions. Glucoside (sugar) based gels are susceptible to hydrolysis under acidic conditions limiting their applications. However, this gel is robust and stable under acidic or basic condition and can be prepared readily. Mr Mishra, highlighting another aspect, said, "GTHCC exhibits gelling properties even at a very low concentration of 0.3 gram per litre with different solvents. There are a very few molecular gels like this that are simple and synthesised from easily available materials. This novel molecule may have good potential in diverse applications like drug delivery agents, cosmetics and petroleum oil scavenging." ]]> <![CDATA[Despite ZMapp treatment, doctor dies of Ebola]]> https://biospectrumindia.com/news/95/4530/despite-zmapp-treatment-doctor-dies-of-ebola.html https://biospectrumindia.com/news/95/4530/despite-zmapp-treatment-doctor-dies-of-ebola.html Sat, 30 Aug 2014 15:14:00 +0530 The Liberian Health Ministry has confirmed the death of a doctor hailing from the country, who had been battling the deadly Ebola virus. The doctor is said to have received the experimental drug ZMapp manufactured by Mapp Biopharmaceuticals. The death of the doctor could dampen the optimism about the drug, that mounted last week when two US doctors who received the treatment were declared healthy and free of the virus. Scientists said that it was too early to confirm the medicinal value of the drug as it had not been tested in humans before administration. Mapp Biopharmaceuticals announced that they were left with modest quantities of the drug and that it would take a long time to produce new stocks of ZMapp. According to the WHO estimates, the disease has affected healthcare workers at large, with nearly 100 healthcare workers dying of the deadly disease. ]]> <![CDATA[Foodborne parasites: The silent killers]]> https://biospectrumindia.com/features/95/5799/foodborne-parasites-the-silent-killers.html https://biospectrumindia.com/features/95/5799/foodborne-parasites-the-silent-killers.html Sat, 30 Aug 2014 14:48:00 +0530 Parasites are organisms that derive nourishment and protection from other living organisms known as hosts. They may be transmitted from animals to humans, from humans to humans, or from humans to animals. Host-to-host consumption of contaminated food and water can also be a source of transmission. These organisms live and reproduce within the tissues and organs of infected human and animal hosts,and are often excreted in feces. They range in size from tiny,single-celled,microscopic organisms (protozoa) to larger,multi-cellular worms (helminths) that can be seen with the naked eye. The size ranges from 1 to 2 Î¼m (micrometers) to 2 meter long. Their lifecycle is also completely different. While some parasites use a permanent host, others go through a series of developmental phases using different animal or human hosts. Food is an excellent vehicle by which many pathogens (bacteria,viruses/prions and parasites) can reach an appropriate colonisation site in a new host. The epidemiology of foodborne disease keeps changing day-by-day. New pathogens have emerged, and some have spread worldwide. Many, in-cluding Salmonella, Escherichia coli O157:H7, Campylobacter, and Yersinia enterocolitica, have reservoirs in healthy food from which they spread to an increasing variety of foods. Although food production practices change, the well-recognised foodborne pathogens, seem to evolve and exploit novel opportunities. These pathogens cause sporadic illness and chronic complications, as well as large and challenging outbreaks over many states and nations. Contamination of foods or beverages with these parasites can result in symptoms ranging from mild stomach upset, headache, muscle aches,and fever to abdominal cramps,vomiting, and diarrhea. Severe cases can result in dangerous dehydration, nerve damage, paralysis, kidney failure,and death. Symptoms may develop within hours or days after eating contaminated food, and they are not always easy to distinguish from influenza or other illnesses.Foodborne parasites are of global concern. A top 10 list identifying the foodborne parasites of greatest global concern was released on July 1, 2014.by Food and Agriculture Organisation(FAO) of the United Nations at Rome. The rankings contained in FAO-WHO report, Multi-criteria-based ranking or risk management of foodborne parasites, are based on the parasites' burden on human health and other factors, and includes information on where they can be found.The list and supporting report were developed following a request by the global food standards body, the Codex Alimentarius Commission for FAO and WHO to review the current status of knowledge on parasites in food and their public health and trade impacts.Foodborne diseases are an important public health problem in the United States. The Foodborne Diseases Active Surveillance Network (FoodNet)conducts surveillance in 10 US sites for all laboratory-confirmed infections caused by selected pathogens transmitted commonly through food to quantify them and monitor their incidence. This report summarises preliminary 2013 data and describes trends since 2006. In 2013, a total of 19,056 infections, 4,200 hospitalisations and 80 deaths were reported. For most infections, incidence was well above national Healthy People 2020 incidence targets and highest among children aged below 5 years. Centers for Disease Control and Prevention (CDC), United States, a government public health agency estimates that each year, roughly 1 in 6 Americans (or 48 million people) gets sick, 1,28,000 are hospitalised, and 3,000 die of foodborne diseases. Foodborne diseases are extremely costly. Health experts estimate that the yearly cost of all foodborne diseases in the USA alone, is about $5-6 billion in direct medical expenses and lost productivity. The last reports from the Health Information of India in 2004 indicates 95,75,112 cases of acute diarrheal diseases, including gastroenteritis.with 2,855 deaths have been recorded and cases of foodborne diseases. In the last decade, India witnessed a couple of following incidents related to outbreaks of foodborne parasites(according to the National Centre for Disease Control (NCDC), Directorate General of Health Services, Government of India). A food poisoning outbreak due toSalmonella paratyphi A, affected33 people, due to vegetarian foodwere reported from Yavatmal(Maharashtra) in 1995.â€¢ Two separate food poisoningoutbreaks due to Salmonellaweltevreden and Salmonellawein affecting 34 and 10 peoplerespectively, due to non-vegetarianfood (Chicken and fish)were reported from Mangalore in2008-09.â€¢ In early 2008, an outbreak ofavian influenza in Bangalore,led to an import ban of Indianpoultry products in the MiddleEast, resulting in losses totalinghundreds and thousands of USdollars to the Indian economy. Foodborne disease have a major impact on the health and economy in developing countries in the tropics and sub-tropics. Complex socioeconomic and socio-cultural factors play a vital role in the origin and maintenance of these conditions.Commenting on foodborne parasites and their impact on Indian population, Priyanka Rohatgi, President, Indian Dietetic Association, Bangalore chapter, said, "In India, foodborne diseases and infections are a serious health hazard causing large numbers of mortality and morbidity. Outbreaks of Hepatitis, Cholera and Botulism are reported every year leading to widespread loss of earnings, work output and physical sufferings. Yet, so little is known about the different types of pathogens, symptoms and treatment modes involved in food safety hazards. It's unfortunate that due to this lack of information, we often categorize all food borne ailments as cases of gasteroenteritis. A list of some important foodborne illnesses to avoid are Salmonellosis, Listeriosis, Campylobacteriosis, Botulism, Cholera, E.Coli infection, Hepatitis." "Scenario of food borne parasitic illnesses in India differs from the rest of the world due to varied food habits across the country. Other factors, such as unhygienic living conditions, lack of education, poor personal hygiene,poverty and occupation, also contribute to the dissemination of parasitic infections. The most common foodborne parasitic infestations in India are Toxoplasmosis, Teniasis, Cryptosporidiosis, Ascariasis (Roundworm infestation), Amoebiasis, Giardiaisis, Hydatidosis and Trichinellosis," said Dr Praveen Kulkarni, Assistant Professor, Department of Community Medicine, JSS University. "India is facing the triple burden of health problems, namely, communicable diseases (incl. parasitic infestations), non-communicable diseases and maternal and child health problems.Containment of communicable diseases is a most crucial and challenging task among all. Illnesses resulting due to food borne parasitic infestations have not received the attention they truly deserve due to negligence of policy makers and health care professionals," said Dr Praveen Kulkarni. How are foodborne diseases treated? There are different kinds of foodborne diseases, which may require different kinds of treatments depending upon the symptoms they cause. Illnesses that are primarily caused can be diarrhea or vomiting, which leads to dehydration. According to treatment approaches mentioned by CDC, if the diarrhea is severe, oral rehydration solution such as Ceralyte, Pedialyte or Oralyte should be drunk to replace the fluid losses and prevent dehydration. Sports drinks such as Gatorade do not replace the losses correctly and should not be used for the treatment of diarrheal illness. Preparations of bismuth subsalicylate can reduce the duration and severity of simple diarrhea. If diarrhea and cramps occur, without bloody stools or fever, taking an antidiarrheal medication may provide symptomatic relief, but these medications should be avoided if there is high fever or blood in the stools because they may make the illness worse. Foodborne parasites are silent killers. They not only spread faster, they appear to be emerging more rapidly than ever before and are able to circumvent conventional control measures. The best way to avoid them is to simply maintain a hygienic lifestyle. As per the proverb, "Prevention is better than cure" it' always better to follow a few simple precautions which can reduce the risk of foodborne diseases. It is necessary to understand the multiple interactions of these pathogens with their environments during transmission along the food chain in order to develop effective prevention measures and control strategies. As said by Mahatma Gandhi, "It is health that is real wealth and not pieces of gold and silver." To maintain a healthy lifestyle, cleanliness plays a vital part.That is why, "Cleanliness is next to Godliness." ]]> <![CDATA[Indian scientists discover "Sanjeevani"]]> https://biospectrumindia.com/news/95/4508/indian-scientists-discover-sanjeevani.html https://biospectrumindia.com/news/95/4508/indian-scientists-discover-sanjeevani.html Sat, 30 Aug 2014 12:22:00 +0530 Researchers at the Defence Institute of High Altitude Research (DIHAR), Leh are exploring the therapeutic values of the local herb Rhodiola. This herb can apparently provide relief from disorders caused as a result of the difficult high altitude areas. According to Mr RB Srivastava, director, DIHAR, Rhodiola is a wonder plant which has immunomodulatory (immune enhancing), adaptogenic (adapting to difficult climatic conditions), and radio-protecting abilities due to the presence of secondary metabolites and phytoactive compounds unique to the plant. It can also mitigate the effects of gamma radiation released due to biochemical warfare. "A concerted effort involving conservation, propagation, and sustainable utilization of this unique medicinal herb will surely result in the rediscovery of Sanjeevani for the troops deployed in extreme climatic conditions, along the Himalayan frontiers," said the director to IANS. The plant has also been found to have anti-depressant and appetizer properties. It has been used in traditional Chinese medicine to combat high-altitude sickness. In Mongolia, physicians prescribe it for diseases like tuberculosis and cancer. Other studies have found the herb to be useful for faster recovery after a heavy workout, for memory enhancement, and cardiac stress reduction. "Our research reveals its potential for anti-aging, tissue regeneration, protecting neurons during lack of oxygen, and cognitive improvement," said Mr Sunil Hota, who is investigating medicinal properties of the plant at DIHAR. The researchers are trying in-vitro propagation of the plant to increase its population. ]]> <![CDATA['e-healthcare business to boost healthcare sector']]> https://biospectrumindia.com/news/95/4334/e-healthcare-business-to-boost-healthcare-sector.html https://biospectrumindia.com/news/95/4334/e-healthcare-business-to-boost-healthcare-sector.html Fri, 29 Aug 2014 12:30:00 +0530 Bangalore: e-healthcare in India will have a major share in the overall healthcare market, believe industry experts. "Currently the overall healthcare market in India is about $150 billion. But the way internet penetration and awareness about healthcare is increasing in India, the e-health care services would grow at a very healthy rate. I expect that very soon, it would contribute about 2 percent in the overall healthcare sector," Mr Ravi Virmani, Credihealth, MD said. Echoing similar views, Mr Vivek Srivastava, CEO, Health Care at Home India said that Internet and mobile phones will further push the growth of the sector. He also added that the business will contribute significantly to the overall healthcare industry. He also believed that it is helping boost medical tourism in the country. With the advent of telecommunication, it has become easier to deliver e-healthcare services. And with the ministry of health and family welfare's recent announcement that they will be starting an e-healthcare service, will also have a positive impact. ]]> <![CDATA[Top 20: BioPharma registers lowest ever growth rate]]> https://biospectrumindia.com/features/95/4815/top-20-biopharma-registers-lowest-ever-growth-rate.html https://biospectrumindia.com/features/95/4815/top-20-biopharma-registers-lowest-ever-growth-rate.html Fri, 29 Aug 2014 12:20:00 +0530 The BioPharma segment recorded a revenue of Rs 15, 853 crore. Here are some of the major highlights: In FY 2013-14, the segment recorded the growth of close to 10 percent. The overall segment did witness exciting times as the sentiment was upbeat due to success of the low cost Rotavirus vaccine program, now being looked at as a major success story. Serum Institute of India is the largest BioPharma company with almost 22 percent share of the entire BioPharma market of Rs 15,853 crore. Biocon accounts for 15 percent market share. The company is estimated to have supplied more than Rs 2000 crore worth of vaccines to UNICEF, making it the largest supplier globally. In FY14, several Indian drug makers were pulled up by the USFDA for noncompliance with current Good Manufacturing Practices (cGMPs). Indian companies are also leading the way, when it comes to neglected diseases. Panacea Biotec is in the early stages of development of a tetravalent dengue vaccine. Indian Immunologicals has also been pooling its efforts into developing vaccines for neglected tropical diseasessuch as chikungunya and kala azar. They are also concentrating efforts on an oral cervical cancer vaccine, a first from the developing world, thus offering its affordability for the masses. Molecular diagnostics or analysis will be the next major revolution in diagnostics. Instrumentation will replace many of the current kits. The future outlook looks good with more than 15-20 percent growth. ]]> <![CDATA[Indian Pharma to grow steadily: Report]]> https://biospectrumindia.com/news/95/4428/indian-pharma-to-grow-steadily-report.html https://biospectrumindia.com/news/95/4428/indian-pharma-to-grow-steadily-report.html Fri, 29 Aug 2014 12:19:00 +0530 The pharmaceutical market in India will continue its double-digit growth, faster than other markets, according to a new report. According to the study by Moody's Investor service, Indian pharma industry will present better growth opportunities than other pharmaceutical markets because of improving socio-economic conditions and access to healthcare against rising prevalence of diseases such as diabetes and cardiovascular disorders. However, drug makers in India could face higher debt levels which will result in mergers and acquisitions (M&A), the report highlighted. According to the report, key Indian companies have generally maintained a low financial leverage and have demonstrated an aversion to risk than their global counterparts, which may be attributed to the concept of high ownership levels by founding family members. Such structures are credit-positive because the interests of creditors and such companies are frequently aligned and often lead to a more a cautious risk appetite. The US represents a substantial growth opportunity for Indian drug makers, given the applications awaiting US Food and Drug Administration (FDA) approval. However, there is certain amount of risk from the FDA manufacturing compliance as in the recent past many Indian plants have received warning letter from the regulator for violating the rules. The new rules making companies responsible for drug safety labelling will also mean greater exposure to legal costs for generics players operating in the US, the report added. ]]> <![CDATA[Novo Nordisk not keen on any major acquisitions]]> https://biospectrumindia.com/news/95/4290/novo-nordisk-not-keen-on-any-major-acquisitions.html https://biospectrumindia.com/news/95/4290/novo-nordisk-not-keen-on-any-major-acquisitions.html Thu, 28 Aug 2014 17:41:00 +0530 However, the company has expressed interest in smaller licensing deals. Mr Sorenson considers the insulin market to be big and growing fast that the company doesn't need to depend on acquisitions. "Major acquisitions and major mergers are hugely distractive and often destructive," he told WSJ. (News Source: The Wall Street Journal) ]]> <![CDATA[Argentina's pharma door flings open for India]]> https://biospectrumindia.com/news/95/6350/argentinas-pharma-door-flings-open-for-india.html https://biospectrumindia.com/news/95/6350/argentinas-pharma-door-flings-open-for-india.html Thu, 28 Aug 2014 15:13:17 +0530 The move is anticipated to create a big boom to the Indian pharmaceutical companies seeking to establish themselves in this part of the world. Indian drug-makers previously were not allowed to supply drugs to Argentina under its constitutional directive. Argentina's pharma industry is estimated to pass $15 billion by 2020, and is said to be the largest pharma market in Latin America. So far, Indian pharma majors including Glenmark, Cadila, and Torrent Pharma already have set up their base in Brazil. Moving ahead, more information could surface from the Argentinian government on pharma import regulations. ]]> <![CDATA[European Commission approves BMS' Daklinza for Hepatitis C]]> https://biospectrumindia.com/news/95/4271/european-commission-approves-bms-daklinza-for-hepatitis-c.html https://biospectrumindia.com/news/95/4271/european-commission-approves-bms-daklinza-for-hepatitis-c.html Thu, 28 Aug 2014 14:50:11 +0530 Today's approval allows for the marketing of Daklinza in all 28 Member States of the EU, said the company's press statement. Daklinza is a potent, pan-genotypic NS5A replication complex inhibitor (in vitro), for use in combination with other medicinal products across genotypes 1, 2, 3 and 4. This molecule when used in combination with Sofosbuvir, is an all-oral, interferon-free regimen that provided cure rates of up to 100 percent in clinical trials, including patients with advanced liver disease, genotype 3 and those who have previously failed treatment with protease inhibitors. This product is said to be the first NS5A complex inhibitor approved in the European Union (EU) and will be available for use in combination with other medicinal products, providing a shorter treatment duration (12 or 24 weeks) compared to 48 weeks of treatment with interferon and ribavirin-based regimens. "The eradication of HCV is in sight, and with today's approval, Daklinza, in combination with other agents, will be an important option to achieve cure across many HCV genotypes and patient types for those in the EU who are in dire need of new treatment choices," said Mr Emmanuel Blin, head of worldwide commercialization, Bristol-Myers Squibb. "We are proud to have discovered, developed and now brought to market this first-in-class NS5A replication complex inhibitor. We look forward to our continued work with EU health authorities to ensure Daklinza-based regimens are available to patients as quickly as possible," he expressed. The marketing authorization for Daklinza follows an accelerated assessment by the Committee for Medicinal Products for Human Use (CHMP), a designation that is granted to new medicines of major public health interest. "HCV is a challenging virus to overcome, requiring multiple modes of attack. With the approval of Daklinza, we have a new class of drug that disrupts the virus in two ways - by inhibiting both viral replication and assembly - and when combined with other compounds often results in cure among even the hardest-to-treat patients," said Mr Michael P Manns, MD, professor and chairman, department of gastroenterology, hepatology, and endocrinology, Hannover Medical School, Hannover, Germany. ]]> <![CDATA[GSK receives FDA approval for Promacta]]> https://biospectrumindia.com/news/95/4199/gsk-receives-fda-approval-for-promacta.html https://biospectrumindia.com/news/95/4199/gsk-receives-fda-approval-for-promacta.html Wed, 27 Aug 2014 14:31:03 +0530 SAA is a blood disorder where the bone marrow fails to make enough red blood cells, white blood cells, and platelets. "FDA approval of Promacta addresses a significant treatment need for this very rare but serious blood disorder in those who have failed current treatment options," said Dr Paolo Paoletti, president, Oncology, GSK. Dr Paoletti further added, "Through collaboration with the National Institutes of Health, whose studies demonstrate the potential for Promacta to achieve a haematologic response in at least one lineage of red blood cells, platelets, or white blood cells, and patients now have a treatment option where one didn't previously exist." ]]> <![CDATA[Venus ties up with Teva for an anti-cancer drug ]]> https://biospectrumindia.com/news/95/4653/venus-ties-up-with-teva-for-an-anti-cancer-drug-.html https://biospectrumindia.com/news/95/4653/venus-ties-up-with-teva-for-an-anti-cancer-drug-.html Wed, 27 Aug 2014 12:28:00 +0530 Venus Remedies has entered into partnership with Teva, the largest manufacturer of generic drugs in the world, for a blockbuster anti-cancer drug in the Canadian market. The high-potential drug is under patent protection till 2016. Venus, based at Panchkula, Haryana, will be initially manufacturing the drug at the Venus Medicine Research Center, its research unit, for assisting Teva in registrations. Thereafter, Venus will also use its manufacturing capabilities to support Teva in enhancing the business from this drug in the Canadian market. Since the anti-cancer market size of Canada alone is $75-100 million, this association will help Venus capture a sizable market share for this product in the first year itself. As per Dr Manu Chaudhary, joint managing director, Venus Remedies and director, Venus Medicine Research Center, said, "We already have an agreement with Teva for two Cephalosporins in the European Union market. The signing of this deal for the Canadian market has further strengthened our relationship and widened the scope of our products. This agreement will enable Venus to penetrate the Canadian market for the first time, thus adding another territory to its quest for quality services. Teva will use the infrastructure and regulatory competence of Venus for the commercialisation of this anti-cancer product in the Canadian market." The good manufacturing practices (GMP) certification granted to Venus for the European Union is also valid for Canada, based on which the Venus infrastructure and regulatory competence will be used for the commercialization of this blockbuster drug in the Canadian market. The current global anti-cancer market size is $130 billion with a share of $2.8 billion for this drug. The drug is widely used for the treatment of malignant pleural mesothelioma and non-squamous non-small cell lung cancer. These cancerous conditions have a market of more than $4 billion, which is estimated to increase to $5.4 billion by 2020, in the regulated markets of the United States, the United Kingdom, France, Germany, Italy, Spain, and Japan. ]]> <![CDATA[Bangalore airport gets cargo terminal for handling pharma products]]> https://biospectrumindia.com/news/95/5549/bangalore-airport-gets-cargo-terminal-for-handling-pharma-products.html https://biospectrumindia.com/news/95/5549/bangalore-airport-gets-cargo-terminal-for-handling-pharma-products.html Wed, 27 Aug 2014 10:24:57 +0530 According to Menzies, the Pharma Cold Zone will offer accurate and temperature controlled care while handling pharmaceutical products. This temperature controlled cargo handling facility is said to greatly assist the south Indian pharma industry in enhancing their business and meeting the stringent requirements of global regulatory authorities. Mr G V Sanjay Reddy, MD, KIAL said, "....This is well timed and in line with the city's emerging status as the pharmaceutical hub of South India...." The state-of-the-art facility provides dedicated truck docks for acceptance, floor-level weighment at acceptance, customs clearance, screening and security clearances, cargo build-up and storage, all under controlled temperature. It is also equipped with data loggers, alarm systems (hooters and SMS) and 24/7 CCTV coverage supported with HD cameras. Mr V S Bobba, MD, Menzies Aviation Bobba said, "With the new and exclusive Pharma Cold Zone facility at our cargo terminal with temperature controlled and state-of-the-art technology, the company would strengthen its leadership and capability in handling and transportation of pharma cargo between Bengaluru and rest of the world." ]]> <![CDATA[US FDA approves Strides' anti-anxiety drug]]> https://biospectrumindia.com/news/95/4047/us-fda-approves-strides-anti-anxiety-drug.html https://biospectrumindia.com/news/95/4047/us-fda-approves-strides-anti-anxiety-drug.html Tue, 26 Aug 2014 16:22:00 +0530 Strides Arcolab has announced that it has received approval from the United States Food and Drug Administration (US FDA) for its generic drug, Buspirone Hydrochloride tablets. The tablets are used for the treatment of anxiety disorders and the short-term relief from the symptoms of anxiety. The approval has been granted for tablets in strengths 5 mg, 10 mg, 15 mg and 30 mg, the company informed. According to IMS data, the US market for generic Buspirone tablets was nearly $65 million in 2013. "The product will be manufactured at the company's oral dosage facility at Bangalore and marketed directly by Strides in the US Market," the company said in a statement. ]]> <![CDATA[Merck & Co inks pact with Advaxis]]> https://biospectrumindia.com/news/95/4043/merck-co-inks-pact-with-advaxis.html https://biospectrumindia.com/news/95/4043/merck-co-inks-pact-with-advaxis.html Tue, 26 Aug 2014 15:08:03 +0530 Merck has collaborated with Advaxis to study the combination of Advaxis's Lm-LLO cancer immunotherapy, and pembrolizumab Merck's investigational anti PD-1 antibody, for the treatment of prostate cancer. The collaboration will evaluate Advaxis' Lm (Listeria monocytogenes)-LLO cancer immunotherapy, ADXS-PSA as a monotherapy and in combination with pembrolizumab in a Phase I/II study of patients with previously treated metastatic, castration-resistant prostate cancer. The study is expected to begin in early 2015. "We are excited to be working with Merck. Equally as exciting is the combination potential of our Lm-LLO immunotherapy with Merck's anti-PD-1 immune checkpoint inhibitor. We believe that the combination of Advaxis Lm-LLO cancer immunotherapies and checkpoint inhibitors holds significant promise for the treatment of prostate and other cancers," said Mr Daniel J O'Connor, president and chief executive officer, Advaxis, in a statement. Mr Eric Rubin, head of oncology, Merck research laboratories, said, "Collaborations like this are an integral part of the company's strategy to evaluate the potential of pembrolizumab in multiple combinations." Pembrolizumab is currently being evaluated across more than 30 types of cancers as a monotherapy and in combination with other drugs. The financial details of the deal were not disclosed. Reportedly, Advaxis will fund the study, while both companies will collaboratively oversee the conduct of the study. ]]> <![CDATA[No confirmed cases of Ebola in India: WHO director]]> https://biospectrumindia.com/news/95/5954/no-confirmed-cases-of-ebola-in-india-who-director.html https://biospectrumindia.com/news/95/5954/no-confirmed-cases-of-ebola-in-india-who-director.html Tue, 26 Aug 2014 14:56:00 +0530 "Despite rumors," said Dr Poonam Singh, "there have been no confirmed cases of Ebola in the eleven countries of WHO's South-East Asia Region, including India." According to Dr Singh, an Ebola Response Roadmap has been developed by WHO with accelerated and focused activities for the next 6 to 9 months. The estimated financial requirement for the implementation of this roadmap is around $430 million, she revealed. The following are the objectives of the roadmap: Full geographic coverage with Ebola response activities in countries with widespread transmission Ensuring emergency application of Ebola response interventions in newly affected countries Strengthening global preparedness "This is the time to step-up preparedness. A successful public health response will need strong health systems with sensitive surveillance, infection control and community mobilization," Dr Singh opined. WHO has been working closely with national authorities in West Africa and leading the international response. Dr Margaret Chan, director general, WHO, visited West Africa and held discussions with heads of governments. More than 400 experts and WHO staff from all over the world have been mobilized to the epicenter of the event in West Africa to assist efforts of national authorities. "We are sharing information on the evolution of the event with all member States along with technical guidelines on all aspects of the disease. Through WHO's accredited laboratories network, and support to shipment of infectious material to these labs, it is assisting countries in establishing a diagnosis of suspected cases," Dr Singh said. Currently there are 45,000 Indians living in the Ebola-affected West African countries. According to a latest report, 6 people who had arrived at Delhi airport this morning from Ebola-hit Liberia have already been quarantined and taken out for various laboratory tests. A NDTV report said that today around 112 passengers are expected to arrive in Delhi and Mumbai airports from the affected regions. ]]> <![CDATA[Use of biotech in agriculture revolutionary: Mr R M Singh]]> https://biospectrumindia.com/news/95/4026/use-of-biotech-in-agriculture-revolutionary-mr-r-m-singh.html https://biospectrumindia.com/news/95/4026/use-of-biotech-in-agriculture-revolutionary-mr-r-m-singh.html Tue, 26 Aug 2014 14:51:57 +0530 Laying the foundation stone of Indian Institute of Agricultural Bio-Technology at Garh Khatanga near Ranchi (Jharkhand) on August 25, 2014, the union agriculture minister, Mr Radha Mohan Singh stated that there is a need for bringing about a second green revolution, particularly, in the eastern states of the country which were not covered earlier during the first green revolution. He mentioned that development can be accelerated in these states because of adequate human resource and suitability of the states for organic farming as use of pesticides, chemicals and fertilizers here is almost nil. As such agricultural biotechnology will play a significant role in increasing quality production in these states. His comments are being looked at as a positive signal as a whole but there is still a lot of air that has to be cleared on genetically modified crops and the regulations surrounding it. Talking further about the inistitute, Mr Singh said that with its opening, the provisions made for biotechnological education will pave a way for developing trained personnel who will create awareness among farmers about advanced agriculture by use of biotechnology techniques along with the traditional methods of farming. The argiculture minister mentioned that in the past due to climatic changes and fluctuations in temperature, agriculture has been adversely affected. This has led to not only reduction in production but has also affected the quality of crops. He further added that with the use of biotechnology the crops can be made climate- resilient and reduction in production can be checked. The minister said that there was an urgent need for setting up such types of institutes in this region. The central government has taken a decision to open the Indian institute of Agricultural Biotechnology in Jharkhand keeping in view the importance of agricultural biotechnology. The mission of this institute will be to strengthen ongoing research work and fundamental research in the field of biotechnology, as also building the human resource capacity. This institute will generate technology to enhance agricultural production, give postgraduate and PhD degrees to students, he said. This will be helpful in the development of quality human resource and in employment generation. This institute will be helpful in strengthening employment security and food security for the tribal population and farmers of this state and the entire country. The government proposes to confer deemed university status to this institute, he added. ]]> <![CDATA[Roche to buy US biotech firm InterMune for $8.3 billion]]> https://biospectrumindia.com/news/95/6088/roche-to-buy-us-biotech-firm-intermune-for-8-3-billion.html https://biospectrumindia.com/news/95/6088/roche-to-buy-us-biotech-firm-intermune-for-8-3-billion.html Mon, 25 Aug 2014 17:57:46 +0530 Roche officially announced that it has entered into a definitive merger agreement to fully acquire InterMune at a price of US$ 74.00 per share in an all-cash transaction. This corresponds to a total transaction value of US$ 8.3 billion on a fully diluted basis. This offer represents a premium of 38% to InterMune's closing price on 22 August 2014 and a premium of 63% to InterMune's unaffected closing price on August 12, 2014. The merger agreement has been approved by the boards of InterMune and Roche. Under the terms of the merger agreement, Roche will commence a tender offer no later than 29 August 2014, to acquire all outstanding shares of InterMune common stock, and InterMune will file a recommendation statement containing the unanimous recommendation of the InterMune board that InterMune's shareholders tender their shares to Roche. The transaction is expected to be neutral to core earnings per share in 2015 and accretive from 2016 onwards. The deal is the culmination of a bidding war for InterMune, with Sanofi, GlaxoSmithKline and Actelion. The acquisition of InterMune, a Brisbane, California-based biotechnology company focused on the research, development and commercialization of innovative therapies in pulmonology and fibrotic diseases, will allow Roche to broaden and strengthen its respiratory portfolio globally. InterMune's lead medicine pirfenidone is approved for idiopathic pulmonary fibrosis (IPF) in the EU and Canada and under regulatory review in the United States. IPF is a progressive, irreversible and ultimately fatal disease characterized by progressive loss of lung function due to fibrosis, or scarring, in the lungs. Roche markets Pulmozyme and Xolair in the US and has other novel therapeutic medicines targeting respiratory diseases in clinical development. Commenting on the transaction, Mr Severin Schwan, CEO, Roche, said, "We are very pleased that we reached this agreement with InterMune. Our offer provides significant value to InterMune's shareholders and this acquisition will complement Roche's strengths in pulmonary therapy. We look forward to welcoming InterMune employees into the Roche Group and to making a difference for patients with idiopathic pulmonary fibrosis, a devastating disease." Roche plans a smooth transition of InterMune employees and operations into the Roche organization, ensuring readiness for an expected launch of pirfenidone in the US in 2014. Commenting on the transaction, InterMune's chairman, CEO and president, Mr Dan Welch, said, "This merger recognizes the significant value created by our team's commitment, hard work and execution for more than a decade to develop and commercialize treatment options for IPF patients and their families. Roche shares our passion and commitment to the IPF community and to ensuring that pirfenidone is available as quickly as possible to patients in the United States, pending FDA approval. Roche's global resources and scale will not only facilitate and accelerate our ability to deliver pirfenidone to more patients around the world, but also to realize our joint vision to bring additional innovative therapies to patients with respiratory diseases." Pirfenidone has been marketed by InterMune in the EU and Canada as Esbriet since regulatory approval in 2011 and 2012 respectively. After previous regulatory review in the USA in 2010, the Food and Drug Administration (FDA) recommended an additional Phase 3 clinical trial to support the efficacy of pirfenidone. The results of this study, the ASCEND trial, were part of the new drug application (NDA) resubmission that InterMune made in May 2014. On 17 July 2014 pirfenidone received breakthrough therapy designation from the FDA. This designation is reserved for drugs that are intended to treat a serious or life-threatening disease or condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints. The target action date, also known as the PDUFA date, for the pirfenidone NDA is November 23, 2014. In addition to pirfenidone, InterMune has research programmes exploring new targets and pathways that may ultimately lead to improved treatment options for people with IPF, and other fibrotic diseases. Citi is acting as financial advisor to Roche and Davis Polk & Wardwell LLP is acting as legal counsel to Roche. Centerview Partners and Goldman Sachs are acting as financial advisors to InterMune and Cravath, Swaine & Moore LLP is acting as legal counsel to InterMune. ]]> <![CDATA[Funding for research will go up significantly: S&T minister]]> https://biospectrumindia.com/news/95/3922/funding-for-research-will-go-up-significantly-st-minister.html https://biospectrumindia.com/news/95/3922/funding-for-research-will-go-up-significantly-st-minister.html Mon, 25 Aug 2014 14:49:54 +0530 Addressing the 70th foundation day function of Indian Institute of Chemical Technology (IICT), Dr Jitendra Singh, minister of state, science and technology and earth sciences (independent charge), Government of India, said that the government is committed to increase the funding for scientific research. He also invited the Indian industry to contribute more for research and development. "Government will also encourage Public Private Partnership (PPP) in view of the emerging areas of innovation", he added. Dr Singh said, IICT Hyderabad has also set up a Biotech Incubation Centre and in this way various scientific institutions based in Hyderabad could coordinate with each other to develop this city as a knowledge hub of India. "Scientific researchers are the real nation builders who work day and night away from the limelight of media or public and remain unaffected by upheavals in their surroundings," Minister added. "The best examples of this is the IICT at Hyderabad which was set up in 1944 during World War II and back home Quit India Movement was at its peak but inspite of all this, the then Nizam of Hyderabad and group of his advisors demonstrated the vision to set up such an institute for the benefit of future generations. Dr Jitendra Singh said that over the last seven decades, the IICT and other establishments of the CSIR have not only fulfilled the academic appetite of researchers but have also created technologies which have contributed to the economy of the nation. Referring to US-India Consortium lead by Hyderabad's IICT, Dr. Jitendra Singh disclosed that presently, eleven partnering institutes and the University of Florida are leading the programme from US side. Union minister for urban development and parliamentary affairs, Venkaiah Naidu, who hails from Andhra Pradesh, said that this institution is the pride of Hyderabad. He emphasized the need to have more women working in the area of science and technology. Mr Naidu said that though he himself is not a student of science but he understands the value of science for the benefit of the society. Dr Lakshmi Kantam, director of IICT Hyderabad, senior scientists Dr Ahmed Kamal and Dr R B N Prasad also spoke on the occasion. Earlier, Dr Jitendra Singh presented CSIR - IICT Foundation Day awards to eminent scientists and also released a book titled "CSIR-IICT@70 years". ]]> <![CDATA[Papaya leaf extracts can cure dengue: Study]]> https://biospectrumindia.com/news/95/5427/papaya-leaf-extracts-can-cure-dengue-study.html https://biospectrumindia.com/news/95/5427/papaya-leaf-extracts-can-cure-dengue-study.html Sun, 24 Aug 2014 17:26:00 +0530 With hundreds of people in Southeast Asia falling prey to the deadly dengue each year, there has been a frantic search for novel and more effective methods to curb the disease. Though Sanofi experts and Ministry of Health, Malaysia are swearing on the maiden dengue vaccine to be available by early 2015, a Malaysian research organization is looking at home-made therapies. A research study led by Dr Soobitha Subenthran and team from the Institute for Medical Research (IMR) in Kuala Lumpur indicated that papaya leaf extracts had magical powers to cure dengue by increasing blood platelet count. Scientists conducted clinical trials on 288 dengue fever patients. Half of them were given papaya leaf juice and other half received standard dengue treatment. These two groups were then constantly monitored and their blood count checked every eight hours for 48 hours. The group administered with papaya juice showed significant rise in platelet counts compared to the control group. Prof Dr Saringat Haji Baie, School of Pharmaceutical Sciences in Universiti Sains Malaysia (USM), Penang, endorsed the findings elaborating that the medication actually worked and studies are underway to prove the properties scientifically. Dr Haji Baie suggested that IMR should deepen the research and find out more biochemical and medicinal aspects of the product which could effectively be used as medication against dengue. With rains showering early on Southeast Asia dengue cases peaked this year, crossing 1000 mark. Mr Dubravka Selenic Minet, a medical officer with the World Health Organization Thailand, said, "The increasing burden of dengue in the Asia-Pacific region is a matter of serious concern since the disease is spreading to new geographical areas." ]]> <![CDATA[Novartis partners with TB alliance ]]> https://biospectrumindia.com/news/95/5422/novartis-partners-with-tb-alliance-.html https://biospectrumindia.com/news/95/5422/novartis-partners-with-tb-alliance-.html Sun, 24 Aug 2014 15:26:00 +0530 Novartis has partnered with Global Alliance for TB Drug Development (TB Alliance) for compounds to fight tuberculosis (TB) that have been discovered at Novartis Institutes for Tropical Diseases (NITD). According to the World Health Organization, there are more than 8.6 million cases of tuberculosis each year, with more than 1.3 million deaths reported annually. TB is a global disease, but has its deadliest impact in resource-poor countries. Current therapies for TB require 6-30 month dosing regimes and there are increasingly drug resistant strains of TB emerging. "TB is one of the scourges of the developing world and new medicines are desperately needed to combat its continued spread," said Mr Mark C Fishman, president of Novartis Institutes for BioMedical Research. "TB Alliance is well placed to take our discoveries and compounds through development for the benefit of patients with TB." "Our long-standing partnership with Novartis gives us confidence in the scientific underpinnings of the TB portfolio," says Mr Mel Spigelman, president and CEO, TB Alliance. "We look forward to advancing the most promising compounds into the clinic to meet the urgent need for new TB treatments." Under the terms of agreement, NITD will fully transfer its TB research and development program to TB Alliance, which will take financial and operational responsibility for continued research, development, approval and distribution of compounds in the portfolio. Included is a novel class of drugs called indolcarboxamides that are active against drug sensitive and multi-resistant strains of TB. One of these preclinical compounds NITD304, blocks MmpL3, a protein essential for the TB bacterium's survival. ]]> <![CDATA[GM flies could save crops]]> https://biospectrumindia.com/news/95/5421/gm-flies-could-save-crops.html https://biospectrumindia.com/news/95/5421/gm-flies-could-save-crops.html Sun, 24 Aug 2014 13:23:00 +0530 Scientist have found a novel solution to control the Mediterranean fruit fly which causes extensive damage to crops. Scientists at the University of East Anglia (UEA) and Oxitec discovered that the release of genetically engineered male flies could be used as an effective population suppression method, which can save crops around the world. Researchers simulated a wild environment within greenhouses and studied the impact of releasing Oxitec flies. "The Mediterranean fruit fly infests more than 300 types of cultivated and wild fruits, vegetables and nuts. It is a real pest to agriculture and causes extreme damage to crops all around the world," said lead researcher Dr Philip Leftwich, from UEA's school of Biological Sciences. He added, "The genetically engineered flies are not sterile, but they are only capable of producing male offspring after mating with local pest females - which rapidly reduces the number of crop damaging females in the population." He further explained, "When we tested the release of the genetically modified male flies, we found that they were capable of producing a rapid population collapse in our closed system. This method presents a cheap and effective alternative to irradiation. We believe this is a promising new tool to deal with insects which is both environmentally friendly and effective." The method works by introducing a female-specific gene into the insects that interrupts development before females reach a reproductive stage. The research was published in the journal Proceedings of the Royal Society B. ]]> <![CDATA[Aurobindo Pharma to expand its APIs unit]]> https://biospectrumindia.com/news/95/6663/aurobindo-pharma-to-expand-its-apis-unit.html https://biospectrumindia.com/news/95/6663/aurobindo-pharma-to-expand-its-apis-unit.html Sun, 24 Aug 2014 13:21:00 +0530 Hyderabad-based pharma player Aurobindo Pharma will be expanding the capacity of its active pharmaceutical ingredients (APIs) unit in Visakhapatnam this fiscal, according to reports. However, the company did not disclose any details of the investment. "Around 1100 cubic metre capacity is being commissioned from February 2015 at Unit-11 in Vizag," the company's managing director Mr N Govindarajan said while announcing the company's first quarter results, adding that the company has also started investing in fulfilling European requirements at its Vizag facility. "Apart from that, we have also started investing in Naidupeta for our future requirement of US oral products," he said. The company has doubled its capex plan for this fiscal, taking it to Rs 600 crore as compared to a total capex of Rs 350 crore in FY14. "The company's new capex, including maintenance, is expected to be in the range of Rs 600 crore for FY 2014-15, which will be evenly spread out over APIs and formulations facilities. The company's operations have resulted in substantial improvement to support the capex through internal cash generation," he further said. ]]> <![CDATA[Venom can cure Cancer: Study]]> https://biospectrumindia.com/news/95/5477/venom-can-cure-cancer-study.html https://biospectrumindia.com/news/95/5477/venom-can-cure-cancer-study.html Sat, 23 Aug 2014 12:41:00 +0530 A new study has discovered that bee, snake, or scorpion venom could form the basis of a new generation of cancer-fighting drugs. A team of researchers at the University of Illinois have devised a method for targeting venom proteins specifically on malignant cells while sparing healthy ones. This step reduces or eliminates side effects that the toxins would cause. Venom from snakes, bees, and scorpions contain proteins and peptides which, when separated from other components and tested individually, can attach themselves to cancer cell membranes. This action could potentially block the growth and spread of the disease. In a research note, Mr Dipanjan Pan, who led the study, said, "We have safely used venom toxins in tiny nanometer-sized particles to treat breast cancer and melanoma cells in the laboratory. These particles, which are camouflaged from the immune system, take the toxin directly to the cancer cells, sparing normal tissue." In future, the team plans to try a combination of the synthesised venom and nanotechnology on cancer cells in rats and pigs. The paper was presented at the American Chemical Society conference. ]]> <![CDATA[145 Indians from Ebola-hit nations return ]]> https://biospectrumindia.com/news/95/5484/145-indians-from-ebola-hit-nations-return-.html https://biospectrumindia.com/news/95/5484/145-indians-from-ebola-hit-nations-return-.html Sat, 23 Aug 2014 12:25:00 +0530 The Indian Health Ministry has confirmed that 145 Indians from Ebola affected countries had arrived in India in the last 24 hours. The Ministry said that all the 145 arrivals were screened at their respective airports in Mumbai (49), Delhi (53), Chennai (12), Kochi (11), Bangalore (14) and Ahmedabad (6), out of which five arrivals were confirmed to have contact history with Ebola cases in West Africa. The details of the five passengers have been submitted to Integrated Disease Surveillance Program (IDSP) for further tracking and necessary 'contact' management, the ministry said in a statement. IDSP said that they have tracked a total of 496 cases so far based on information provided by the Airport authority of India. Meanwhile, The Indian Medical Association conducted a meeting to educate its staff on Ebola virus, its precautions and symptoms. The Ministry said that all precautions were in place and the chances of Ebola spreading on Indian soil remained low. ]]> <![CDATA[â€œAgrovisionâ€? Central India's largest Agricultural Summit Introducing its Southern Edition in Belgaum]]> https://biospectrumindia.com/news/95/6721/agrovision-central-indias-largest-agricultural-summit-introducing-its-southern-edition-in-belgaum.html https://biospectrumindia.com/news/95/6721/agrovision-central-indias-largest-agricultural-summit-introducing-its-southern-edition-in-belgaum.html Fri, 22 Aug 2014 22:40:00 +0530 Bangalore, August 22, 2014: Karnataka Small Scale Industries Association (KASSIA) in association with MM Activ Sci-Tech Communications today announced that Central India's largest Agricultural Summit "Agrovision" is expanding its wings to South India by hosting the South Edition of Agrovision in Belgaum, Karnataka from February 21-23, 2015 at Belgaum Exhibition Complex, Autonagar, Belgaum. The highlights of the three day mega event will be an Exhibition, Conference and Workshops. "Agrovision South" will also showcase Innovations in Agriculture - a program for start-ups, a buyer-seller meet, an Agri Captains Conclave - a platform for Industry and Investors, a Policy Makers Users Conclave and the Agro Vision South Excellence Awards.The announcement was made in the presence of Sri Krishna Byre Gowda - Hon'ble minister of state for Agriculture, (Independent Charge), Government of Karnataka, Shri Mahendra Jain, IAS, principle secretary to Government, Co-op Department [Agriculture (I/C)], Government of Karnataka, Shri Chidananda M. Rajamane, president, KASSIA and Shri Ravi Boratkar, Jt managing director, MM Activ Sci-Tech Communications. Agrovision South's core theme will be "Building Sustainable Livelihoods and Increasing Farmers' Income". The event will be a three-day Knowledge and Technology Exhibition on farm practices and food processing creating a unique opportunity for Small scale industries, entrepreneurs and farmers to assimilate the latest products, services, technology in Agriculture and allied sectors. Agrovision South is expected to receive active participation of Industry/Corporate, Government organisations, Policy makers, Academia and farmers, small scale industries, consumers etc.Speaking on the need for Agrovision South, Mr Ravi Boratkar said, "The Govt. of Karnataka considers agriculture and allied industries as high growth sectors to accelerate the state's GDP and enable farmers to boost their income as well as ensure food security. The challenges faced by the agriculture sector which supports a majority of the state's population needs to be addressed on priority. Agrovision South shall induce the adoption of new technologies and use of modern farm practices amongst farmers and showcase the emerging opportunities for entrepreneurs in the much needed Agri-infrastructure and Agri-services sectors." Sri Chidananda M Rajamane giving details of the Expo emphasized that "Learn More, Earn More (LMEM)" concept holds good especially in the case of agriculture which requires assimilation of new technologies by the farmers. "Many overseas organizations related to the farm and food processing sector have evinced interest in participating in the event which is likely to be supported by some government organizations and institutional stakeholders," he added.The Expo will showcase the best of farm technologies both from within the country and abroad, latest innovative measures to increase crop productivity, soil testing techniques, harnessing farm produce from lab to land, and agricultural extension practices such as food processing and related sectors. Apart from Exhibition, Agrovision South will also have a one day Conference on the role and contribution of small scale industries on the agriculture and allied sectors like food processing, storage etc.Workshops will be conducted on topics like Small Scale Industries: Value addition and Growth prospects, Dairy development, Poultry, Pre and Post Harvesting Technologies, Entrepreneurship opportunities in Agriculture, developing service sector in rural India etc. Workshops will attract large number of participants as they will be provided with information on latest techniques, close interaction with the experts for all their queries, doubts and find the remedy. The organizers expect wide participation from agro, food processing and related sectors across south India and in particular from the neighbouring districts of Belgaum, Bijapur, Bagalkot, Bidar, Bellary, Gulbarga, Raichur, Yadgiri, Gadag, Dharwad, Haveri, Koppal, in addition to several central PSUs and large industries. ]]> <![CDATA[BMS, Celgene to collaborate on a combination trial]]> https://biospectrumindia.com/news/95/5420/bms-celgene-to-collaborate-on-a-combination-trial.html https://biospectrumindia.com/news/95/5420/bms-celgene-to-collaborate-on-a-combination-trial.html Fri, 22 Aug 2014 16:44:40 +0530 BioPharmaceutical major Bristol-Myers Squibb (BMS) and Celgene have teamed up to conduct a combination clinical trial. The aim of the collaboration is to evaluate safety, tolerability, and preliminary efficacy of a combination regimen of Bristol-Myers Squibb's investigational PD-1 immune checkpoint inhibitor OPDIVO (nivolumab), and Celgene's nab technology-based chemotherapy ABRAXANE (paclitaxel protein, albumin-bound particles for injectable suspension), in a Phase I study. Multiple tumor types will be explored in the study including HER-2 negative metastatic breast cancer, pancreatic cancer, and non-small cell lung cancer (NSCLC). OPDIVO is a part of a new class of cancer treatments known as immunotherapies that are designed to harness the body's own immune system to fight cancer. It targets distinct regulatory components of the immune system, while ABRAXANE works by interfering with the ability of the cancer cells to divide. By combining an immunotherapy with a standard chemotherapy, the companies will explore whether these two agents may lead to an enhanced anti-tumor response compared to individual agents. "Bristol-Myers Squibb continues to forge partnerships focused on exploring the effects of combination regimens that utilize promising therapies from our immuno-oncology portfolio," said Mr Michael Giordano, senior vice president, oncology development, Bristol-Myers Squibb. He added, "Through this collaboration, Bristol-Myers Squibb and Celgene will work together to advance the science and understanding of how the body's own immune system and chemotherapy might work together to fight cancer." Mr Markus Renschler, MD, senior vice president, global head of hematology and oncology medical affairs, Celgene said, "Our collaboration with Bristol-Myers Squibb further underscores our commitment to understanding and modulating the immune system to advance the treatment paradigm in cancer. We believe that ABRAXANE is appropriate as a combination partner for novel immuno-oncology therapies due to its proven anti-tumor activity and that it can be administered without steroid premedication." The study is expected to begin in the fourth quarter of 2014 and will be conducted by Celgene. ]]> <![CDATA[USFDA nod for Zydus Cadila's Acyclovir ]]> https://biospectrumindia.com/news/95/5424/usfda-nod-for-zydus-cadilas-acyclovir-.html https://biospectrumindia.com/news/95/5424/usfda-nod-for-zydus-cadilas-acyclovir-.html Fri, 22 Aug 2014 16:40:05 +0530 The highest regulatory body has approved Zydus Cadila's anti-viral drug, Acyclovir. The company can now go ahead with the marketing of the drug. "Zydus Cadila has received the final approval from the US FDA to market Acyclovir tablets. The drug falls under the anti-viral segment," the company said in a statement. The approval has been granted for Acyclovir tablets in strengths of 400 mg and 800 mg, the company further said. As per IMS, the estimated sales for these tablets in 2014 is $55.8 million. This is the second FDA approval that the company has received this month. Earlier this month, its kidney stones drug, Potassium Citrate tablets were approved by the regulator. The company has a total 95 approvals and has so far filed 249 ANDAs. ]]> <![CDATA[US FDA approves GSK's asthma drug]]> https://biospectrumindia.com/news/95/5419/us-fda-approves-gsks-asthma-drug.html https://biospectrumindia.com/news/95/5419/us-fda-approves-gsks-asthma-drug.html Fri, 22 Aug 2014 16:29:32 +0530 GlaxoSmithKline (GSK) has announced that the United States Food and Drug Administration (US FDA) has approved Arnuity Ellipta (fluticasone furoate inhalation powder), a once-daily inhaled corticosteroid (ICS) medicine for maintenance treatment of asthma as prophylactic therapy in patients aged 12 years and older. However, Arnuity is not indicated for relief of acute bronchospasm. It has been approved in the dosages of 100 mcg and 200 mcg. It is administered once daily via the dry powder inhaler Ellipta, which is also used across a range of other approved respiratory medicines in the GSK portfolio. "The approval of Arnuity Ellipta is an important development for GSK and our expanding respiratory portfolio. It is the first asthma treatment from our new portfolio to have gained approval in the US and enables us to begin expanding the range of medicines that we offer to physicians and appropriate patients," Mr Darrell Baker, SVP and head, GSK global respiratory franchise, said. The efficacy and safety of this drug have been evaluated in more than 3,600 patients with asthma. ]]> <![CDATA[USFDA approves Cerdelga for a rare genetic disorder]]> https://biospectrumindia.com/news/95/5408/usfda-approves-cerdelga-for-a-rare-genetic-disorder.html https://biospectrumindia.com/news/95/5408/usfda-approves-cerdelga-for-a-rare-genetic-disorder.html Fri, 22 Aug 2014 12:00:00 +0530 Gaucher disease occurs in people who do not produce enough of an enzyme called glucocerebrosidase. The enzyme deficiency causes fatty materials to collect in the spleen, liver and bone marrow. The major signs of Gaucher disease include liver and spleen enlargement, low red blood cell counts (anemia), low blood platelet counts and bone problems. Cerdelga is said to be a hard gelatin capsule containing eliglustat that is taken orally. In patients with Gaucher disease Type-1, the drug slows down the production of the fatty materials by inhibiting the metabolic process that forms them. ]]> <![CDATA[Dr Reddy's under scanner for packaging violations]]> https://biospectrumindia.com/news/95/5342/dr-reddys-under-scanner-for-packaging-violations.html https://biospectrumindia.com/news/95/5342/dr-reddys-under-scanner-for-packaging-violations.html Fri, 22 Aug 2014 10:51:42 +0530 According to reports, the US department of justice has issued a warning notice to Dr Reddy's. It states that the company's packaging is in violation of the consumer product safety act (CPSA) involving child resistant packaging regulations. However, the company has denied the consumer product safety commission's (CPSC) allegations in the US securities and exchange commission (SEC) filing. The filing said, "The company disagrees with the CPSC's allegations and is engaged in discussions with them regarding its compliance with the regulations. Simultaneously, the department of justice (DOJ) is also currently investigating a complaint related to these issues under the federal false claims act." In a letter issued to the company, the CPSC alleged that it has violated the consumer product safety act (CPSA) and the poison prevention packaging act (PPPA), and intends to seek civil penalties. It also said that the company has failed to issue general certificates of conformance. In addition, the CPSC has claimed that the company has violated the CPSA by failing to immediately advise the commission of the alleged violations. ]]> <![CDATA[BMS, Pfizer to present clinical trials data on Eliquis]]> https://biospectrumindia.com/news/95/5393/bms-pfizer-to-present-clinical-trials-data-on-eliquis.html https://biospectrumindia.com/news/95/5393/bms-pfizer-to-present-clinical-trials-data-on-eliquis.html Fri, 22 Aug 2014 10:31:48 +0530 The new clinical trial data and New Global Health Economics and Outcomes Research (GHEOR) analyses assessing cost effectiveness and real-world use to reinforce the alliance's commitment to the ongoing analysis of Eliquis in both the nonvalvular atrial fibrillation (NVAF) and venous thromboembolism (VTE). BMS in a statement also said that 14 abstracts will be presented, including new analysis from the ARISTOTLE, AMPLIFY and AMPLIFY-EXT trials evaluating patients with NVAF and VTE. ]]> <![CDATA[Its a new CEO for Monsanto India ]]> https://biospectrumindia.com/news/95/5337/its-a-new-ceo-for-monsanto-india-.html https://biospectrumindia.com/news/95/5337/its-a-new-ceo-for-monsanto-india-.html Fri, 22 Aug 2014 10:10:00 +0530 The current CEO, Dr Gyanendra Shukla, will transition as regional lead of Monsanto's Africa Region. He is said to lead Monsanto's efforts to transform agriculture in Africa. Ms Shilpa is expected to assume the new role from Dr Shukla for both the offices beginning this September 1, 2014, said Monsanto's press statement. Speaking on the occasion, Dr Shukla said, "Shilpa's breadth of experience and understanding of agriculture in India will bring valuable perspective to deepen Monsanto's commitment to India." ]]> <![CDATA[Digital technology to help identify a perfectly healthy human body]]> https://biospectrumindia.com/views/95/5335/digital-technology-to-help-identify-a-perfectly-healthy-human-body.html https://biospectrumindia.com/views/95/5335/digital-technology-to-help-identify-a-perfectly-healthy-human-body.html Thu, 21 Aug 2014 15:58:59 +0530 Modern medicine has benefitted immensely from the wide array of high tech medical equipment that have made diagnosis and treatment methods quicker and less strenuous for doctors and patients. From simple diagnostic kits to high-end MRI and CAT scans to key hole surgeries to artificial organs now developed through 3-D printers all come in handy after some disease strikes a human being. At the same time, scientists have not given up their quest for search within the human body to look for clues that will warn one before the disease's onset. Thousands of research papers have nibbled at this task from various angles but there is no single explanation for what constitutes a perfect and healthy human body. If this aspect is known, then the next task will be to replicate the same conditions in all humans. But this gigantic task has not got a big boost with the entry of a company that has made its name for searching everything that humans want in terms of information outside the human body. Yes. I am referring to the world's most ubiquitous symbol for search, Google. The company has now decided to dedicate its vast computing and brain power resources to search into the human body. According to a special report by The Wall Street Journal newspaper, the company's research wing Google X, has been tasked with search inside the human body. Started two months ago, the project, Baseline Study, is an attempt to collect anonymously the molecular and genetic data of 175 volunteers initially and later extend to thousands of healthy people and study the data thoroughly using the company's formidable computing power and look for clues. Headed by a molecular biologist, Dr Andrew Conrad, a team of about 100 scientists will look for biomarkers or patterns of human health that can be used for early detection of disease. Experts from Duke and Stanford universities are part of the project to ensure that privacy and ethical concerns are taken care of and Google does not have a free run with people's genetic and molecular data. Dr Sam Gambhir of Stanford Medical School will be the key ombudsman for the ambitious project.If successful, it will provide scientists and doctors plenty of insights into how the human body works and how prevention can be in-built into each one at an early stage itself. If this happens, healthcare as we know may change forever in a different direction. Digital technologies are already becoming intrusive and integral part of our bodies. On the anvil are biosensors that can be embedded into our bodies as easily as marking a tattoo. These sensors will use telecom technologies and transmit real time various body parameters, how prescribed medicines work etc. and could be available through right apps. In fact, some experts feel that analysis of such data will be able to forewarn how various human systems are inching towards collapse and hence predict timelines for death. Knowing these things in advance, it may be possible for an individual to prolong life with appropriate interventions. Many of these have immense possibilities in the very near future. ]]> <![CDATA[KVK system effective in linking farmers to the market ]]> https://biospectrumindia.com/news/95/5338/kvk-system-effective-in-linking-farmers-to-the-market-.html https://biospectrumindia.com/news/95/5338/kvk-system-effective-in-linking-farmers-to-the-market-.html Thu, 21 Aug 2014 15:57:39 +0530 The minister of state for agriculture and food processing industries, Dr Sanjeev Balyan, has appreciated Krishi Vigyan Kendras (KVKs) for carrying the technologies to the farmers and shared that KVK scientists have to work not only as scientists but also as social change agents. While addressing the KVK-Interface Workshop on 'Intervention in Tribal Areas and Enhancing efficiency', the minister said that ICAR is playing an important role in the agricultural development of the country. "They have to work hard for the development of entrepreneurs in the villages so that rural youth are retained in agriculture and these entrepreneurial activities should be linked with the market for sustenance," said Dr Balyan. He also interacted with the participants to get suggestions for the improvement of the efficiency of the present system. He also visited the exhibition organized by KVKs on the occasion. Dr S Ayyappan, secretary, DARE and director general, ICAR welcomed the dignitaries and stated that the KVK system is a 40-year-old district level institution and presently, there are 639 KVKs working under the administrative setup of SAUs, ICAR Institutes, NGOs, and state governments. He highlighted that KVKs have been reorganized as an important platform for the transfer of technologies to farmers. He also shared his concern on the constrains that need to be addressed. He asked KVKs to develop a "Passion for technology and compassion for farmers". Vice Chancellors, DDGs, ADGs, directors, NGO heads and program coordinators of the KVKs also participated in the workshop. The interface workshop was organized by division of agricultural extension of ICAR. (Source: Agricultural Extension. Division, ICAR) ]]> <![CDATA[ICAR commercializes Arecanut tissue culture technology ]]> https://biospectrumindia.com/news/95/5328/icar-commercializes-arecanut-tissue-culture-technology-.html https://biospectrumindia.com/news/95/5328/icar-commercializes-arecanut-tissue-culture-technology-.html Thu, 21 Aug 2014 15:37:14 +0530 A memorandum of understanding (MoU) on Arecanut tissue culture technology was signed between the Central Plantation Crops Research Institute, Kasaragod and Sunglow Biotech, Coimbatore. The MoU was handed over by Dr N K Krishna Kumar, DDG (Horticulture Science), ICAR to Mr TS Chelliah, Sunglow Biotech in a function presided over by Dr George V Thomas, director, CPCRI. Arecanut tissue culture protocol using inflorescence explant, standardized at CPCRI, has commercial value for rapid multiplication of elite genotypes such as Yellow Leaf Disease (YLD) resistant palms and dwarf hybrids. More than 60 arecanut palms that were propagated using this protocol have been planted in different locations. Their growth and reproduction are similar to seed-borne plants. In addition, a MoU was signed with DJ Farm, Bangalore for commercialization of coconut embryo culture protocol. Embryo culture protocol of coconut was standardized at CPCRI during 1992-1996 and was successfully used for the collection of exotic germplasm since 1997. The protocol has received international acclaim and is being used in different coconut growing countries. A total of 45 accessions have been collected using this protocol from eight countries. During the function, a promising technology for the collection of fresh and hygienic neera and the production of natural coconut sugar was handed over to Mr Sunny George, chairman, Thejaswini Coconut Farmers Producer Company, Cherupuzha, Kannur. As part of the BPD Unit in CPCRI, an Agribusiness incubation center was inaugurated by the DDG on the occasion. The BPD unit attracted over 85 walk-ins, interested in coconut-based technologies of which 24 registered as incubatees. Facilities are a part of the center to enable practical experience for the incubatees on processing, packaging, selling, marketing, and revenue generation of selected coconut value added products such as virgin coconut oil, coconut chips, desiccated coconut etc. (Source: CPCRI, Kasaragod) ]]> <![CDATA[Venus gets its first Swiss marketing authorization for Gemcitabine ]]> https://biospectrumindia.com/news/95/5336/venus-gets-its-first-swiss-marketing-authorization-for-gemcitabine-.html https://biospectrumindia.com/news/95/5336/venus-gets-its-first-swiss-marketing-authorization-for-gemcitabine-.html Thu, 21 Aug 2014 14:29:30 +0530 Venus Remedies, a leading research-based global pharmaceutical company, has achieved a landmark by securing its first marketing authorization in Switzerland from Swiss drug authority Swissmedic for Gemcitabine, an oncology drug, through Venus Pharma GmbH, its Germany-based subsidiary. This marketing approval for Gemcitabine 200 mg and 1 g injections will help Venus Remedies further strengthen its oncology portfolio and improve its presence in the oncology space. The company is planning to launch the drug early in the next quarter of this fiscal year. The product will be launched in Switzerland by Swiss Pharma GmbH, with which Venus has a marketing tie up. Being among the first few pharma firms to receive a marketing authorization for Gemcitabine and the first Indian company to get a marketing approval for this product from Switzerland, Venus enjoys a competitive edge over other players and is all set to capture a substantial share in the Swiss market for Gemcitabine. The launch of this product will add to the company's top line and bottom line in the coming quarters. This achievement has, once again, proved the company's R&D capabilities and its expertise in developing world-class products with regulatory might, considering that the dossier was developed as per international guidelines, as a generic against the originator's product (Gemzar of Eli Lilly's, a major global pharma player). Venus Remedies has already received more than 20 marketing approvals for Gemcitabine injection from various countries. The product is being sold in the UK, Poland and Germany. Riding on this marketing approval, the company is expecting to generate good revenue this year. Gemcitabine is a first-line anti-cancer drug which is used in the treatment of a variety of cancerous conditions, including the cancer of the lungs, pancreas, bladder, and breast. Gemcitabine, in combination with Cisplatin, received US-Food and Drug Administration (FDA) and European Medicines Agency (EMEA) approvals as a first-line treatment for lung cancer, which is the most common form of cancer worldwide and accounts for 1.2 million fresh cases annually. All set for explosive growth, Gemcitabine remains amongst the choicest drugs even after becoming generic. It is the only approved drug for pancreatic cancer that has a survival rate of below 3 percent and has been established as the gold-standard drug therapy for this form of cancer. According to the European Cancer Observatory, 2,16,000 cases are diagnosed with pancreatic cancer per annum, of which 77,940 died in 2012 alone. The mortality of pancreatic cancer is high, making it the fourth deadliest cancer for both men and women. ]]> <![CDATA[Biotech Cos hesitant to invest in rare disorders R&D]]> https://biospectrumindia.com/news/95/5283/biotech-cos-hesitant-to-invest-in-rare-disorders-rd.html https://biospectrumindia.com/news/95/5283/biotech-cos-hesitant-to-invest-in-rare-disorders-rd.html Thu, 21 Aug 2014 10:23:03 +0530 "We have the talent and the money, however, it is not coordinated into actual deliverables. We have the largest biotech companies here. Many are interested in investing in rare disorders R&D. But the moment they think in terms of marketing and business, that is where the hesitancy is," she commented. Many biotech and pharma companies seem to invest millions in cancer research. "Rare diseases affect patients throughout their lives. Treating rare diseases is life-long. That's where we can see potential business opportunities," she said. "Treated children suffering from rare diseases can live a normal life like everyone else. They are not mentally retarded. But they do have some physical disabilities," she opined. Enzyme replacement therapy or ERT is critical to improve the quality of life for patients suffering from rare genetic disorders. "Without treatment, there is progressive accumulation of partially degraded compounds which stealthily leads to multiorgan dysfunction," Dr Bhat revealed. The government of Karnataka made a historic decision to include treatment of rare diseases children in Karnataka, and made a budgetary provision in 2014-15 to set up a special unit at Indira Gandhi Institute of Child Health. "Treatment for LSD is beyond the reach for most patients. Government support in terms of funding is imperative to help them lead a normal life. We urge the Karnataka government to release funds already allocated in the state budget for the treatment of rare diseases without any further delay so that patients get timely treatment," said Mr Manjit Singh, president, Lysosomal Storage Disorder Support Society (LSDSS). ]]> <![CDATA[Pfizer seeks US FDA approval for its new drug]]> https://biospectrumindia.com/news/95/5287/pfizer-seeks-us-fda-approval-for-its-new-drug.html https://biospectrumindia.com/news/95/5287/pfizer-seeks-us-fda-approval-for-its-new-drug.html Wed, 20 Aug 2014 17:51:51 +0530 Pfizer has announced that it has completed the submission of a New Drug Application (NDA) to the United States Food and Drug Administration (US FDA) for palbociclib. This NDA requests FDA approval of palbociclib, in combination with letrozole, for the treatment of post-menopausal women with estrogen receptor positive (ER+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer who have not previously received systemic treatment for the disease. The submission is based on the final results of PALOMA-1, a randomized Phase 2 trial comparing palbociclib and letrozole versus letrozole alone in a group of patients in an advanced stage. The regulatory body handed the drug a breakthrough therapy designation for its first-line systemic treatment of women with advanced or metastatic ER+, HER2- breast cancer. This designation was based on interim data from the PALOMA-1 trial. "This submission marks an important milestone for Pfizer and palbociclib, and a potential advancement for women with advanced breast cancer," said Mr Garry Nicholson, president, Pfizer Oncology. ]]> <![CDATA[Glenmark develops a novel antibody]]> https://biospectrumindia.com/news/95/5280/glenmark-develops-a-novel-antibody.html https://biospectrumindia.com/news/95/5280/glenmark-develops-a-novel-antibody.html Wed, 20 Aug 2014 16:14:57 +0530 The company enters oncology with the discovery and the initiation of IND enabling studies of this innovative bispecific antibody GBR 1302. This is the first bispecific antibody based on Glenmark's proprietary BEAT platform, said the company's press statement. The antibody was discovered and developed by the Glenmark Biologics Research Centre located in La Chaux-de-Fonds, Switzerland. Commenting on this milestone, Dr Michael Buschle, CSO and president - Biologics, Glenmark Pharmaceuticals said, "GBR 1302 is significant for Glenmark on multiple levels. It is our first bispecific antibody. It is our first antibody based on our proprietary BEAT antibody engineering platform and it represents the entry of Glenmark into the oncology innovator space, which has a huge commercial potential." The discovery is based on Glenmark's innovative BEAT antibody technology platform which facilitates the efficient development and manufacture of antibodies with dual specificities termed, bispecific antibodies. This is said to be the first clinical development candidate based on the BEAT technology. Glenmark expects to obtain approval for the initiation of clinical studies during this financial year. HER2, also known as HER2/neu, or receptor tyrosine-protein kinase erbB-2, is the target of the antibody cancer drugs Trastuzumab, Pertuzumab and Trastuzumab Emtansine and is involved in breast cancer and ovarian cancer. GBR 1302's mode of action is different from current HER2 targeting antibodies. It redirects cytotoxic T-cells through its CD3 binding arm onto HER2 expressing cancer cells and induces the killing of the cancer cells. The killing of cancer cells by GBR 1302 is more rapid, more complete and not subject to the same resistance escape mechanisms as competing therapies claimed Glenmark's press release. With the invention of the BEAT technology Glenmark's scientists have now overcome these bottlenecks and GBR 1302 is the first drug candidate based on this antibody engineering breakthrough technology. ]]> <![CDATA[Sanofi to license two of its pre-clinical drugs]]> https://biospectrumindia.com/news/95/5275/sanofi-to-license-two-of-its-pre-clinical-drugs.html https://biospectrumindia.com/news/95/5275/sanofi-to-license-two-of-its-pre-clinical-drugs.html Wed, 20 Aug 2014 15:33:04 +0530 Sanofi is licensing two of its preclinical respiratory compounds to China's ZAI Lab, as per reports. Financial details of the deal were not disclosed. The drugs show promise as potential treatments for chronic obstructive pulmonary disease, asthma, and idiopathic pulmonary fibrosis. In China, according to the World Health Organisation (WHO), chronic respiratory diseases are the second leading cause of death. It is estimated that over 50 percent of Chinese men smoke and the pollution levels are also major contributors. Ms Samantha Du, Zai Lab's chief executive, said, "ZAI Lab's vision is to develop innovative medicines that can treat patients with serious medical conditions including chronic respiratory diseases. Diseases such as COPD and asthma, with no effective treatments, are becoming leading causes of morbidity and mortality in China. By working with Sanofi, ZAI Lab intends to initiate development to bring effective therapies to patients globally." The Shanghai-based company has launched over half a dozen drugs globally and has successfully taken five candidates into clinical trials in China. ]]> <![CDATA[Dr Vardhan: Need 'health sainiks' to achieve cent percent immunization]]> https://biospectrumindia.com/news/95/5286/dr-vardhan-need-health-sainiks-to-achieve-cent-percent-immunization.html https://biospectrumindia.com/news/95/5286/dr-vardhan-need-health-sainiks-to-achieve-cent-percent-immunization.html Wed, 20 Aug 2014 15:01:31 +0530 "The fact that 14 lakh children do not live beyond the age of five is a matter of national shame. To change this reality the government needs the collective energy of the people, and should not rely on the government machinery", stated the union health minister, Dr Harsh Vardhan in New Delhi on August 20, 2014. While launching a music video, "Phool khil jayenge" ("The flower will bloom"), on the subject of immunization, he asked for greater public participation. "Let's make a pledge here to become 'health sainiks' and each of us would strive to inspire other ordinary people to become health volunteers and work for a healthy nation," he said. Dr Vardhan intends to replicate the means utilized to create a successful polio program during his tenure as Delhi's health minister when he had motivated hundreds of school children to become "polio sainiks". They were given the task of seeking out families with small children who needed polio immunization. "Today, we are poised to replicate India's success with polio eradication. This was brought about by the unrequited and unpaid labour of thousands of people. We need many more such heroes and heroines to make Universal Immunization in India a success," the minister said during the panel discussion. The five-minute film released on the occasion emphasises the importance of providing immunity from diseases to a child through timely inoculation. ]]> <![CDATA[India's contribution a mere 2% in clinical research]]> https://biospectrumindia.com/news/95/5288/indias-contribution-a-mere-2-in-clinical-research.html https://biospectrumindia.com/news/95/5288/indias-contribution-a-mere-2-in-clinical-research.html Wed, 20 Aug 2014 13:28:00 +0530 Despite being home to one sixth of the world's population and carrying one fifth of the world's disease burden, yet less than 2 percent of global clinical research takes place in India. This is bad news for patients suffering from critical diseases. The reasons for the decrease include issues such as regulatory hassels, anti-trial activists, compensation issues, patient deaths etc. Ms Suneela Thatte, president, Indian Society for Clinical Research (ISCR) said "The quest for finding superior and lifesaving medicines is an ongoing one. For every medicine and device that gets a marketing approval, there is a larger story of years of research in laboratories and extensive patient participation in clinical trials to determine their safety and efficacy." She further added, "Patients help patients. Today all of us have access to better and newer treatments because of patients who have participated in clinical trials. Thus, we are all beneficiaries of clinical research. Yet it is unfortunate that the progress of clinical research in India has been stalled by several extraneous factors denying patients the opportunity to participate in and benefit from ongoing clinical research. The impact of this on patients is huge. A slowdown in clinical research in the country means little or no access to newer and better medicines for our patients and a rising disease burden." "Due to the existing tumultuous clinical trials milieu in the country, new drug development is totally hampered. We have a huge rise in the number of NCDs including depression, hypertension, and cancer, and soon we will be the diabetes capital of the world. At the same time, there are diseases which are reflective of a developing economy like TB, malaria, and leprosy among others. Unfortunately, we do not have satisfactory treatments for these diseases. Also, we have HIV, and recently the Ebola, for which there is no cure at present," emphasized Ms Thatte. "If we do not forge into clinical research and drug development, soon we will face issues for which we will not have satisfactory access to medicines," she added. The current uncertainty in clinical trials in India discourages Indian companies from performing clinical research and drug development. "Clinical trials are crucial to attack the diseases bothering our country. No companies from the West are going to think about TB, which is a major issue here in our own country," she justified. Ms Thatte also opined that it is important to have a balanced regulatory environment. "It is important to take care of the interests of patients participating in clinical research, and never compromise on their safety," she said. During the discussion, she also pointed out that negative publicity and existing uncertain regulatory environment have affected Indian pharma companies including multinationals. "Many MNCs are going away from India, proving it to be an unfavorable destination for clinical trials. Sadly, Indian companies too, involved in drug development are pulling out of the country," she lamented. It is not just the clinical research industry, but also academic research that bears the brunt. "Cutting-edge technologies have come out of academic research as well, especially in the area of cancer. Its contribution has been exceptional, ensuring the availability of attractive treatments," she said. Ms Thatte holds the opinion that a clinical trial environment should support innovation. "Without innovation there will be no progress and our disease burden is not going to be addressed," she stated. She concluded by saying that it is imperative to create awareness on the regulatory environment, which protects the interests of the subjects and patients taking part in clinical research. "At the same time, the clinical research environment should also be balanced. Regulations should always be stringent and never relaxed. Otherwise, the clinical data collected after spending millions of dollars in the country will be rendered useless," concluded Ms Suneela Thatte. ]]> <![CDATA[South-East Asia bears NCDs brunt]]> https://biospectrumindia.com/news/95/5189/south-east-asia-bears-ncds-brunt.html https://biospectrumindia.com/news/95/5189/south-east-asia-bears-ncds-brunt.html Tue, 19 Aug 2014 17:10:06 +0530 These diseases kill 8.5 million people annually in WHO's South-East Asia Region. Of these, 4.2 million deaths are considered premature. The region is home to a quarter of the world's population and a third of the world's poor, those most vulnerable to the negative economic impact of NCDs. The macro-economic burden of NCDs in low-and middle-income countries is projected to be $7 trillion from 2011 to 2025. Wide-scale implementation of 'Best Buy' interventions for prevention would cost a fraction of this. "We are seeing that heart diseases, diabetes, cancers, and chronic respiratory diseases now affect younger and younger people. Deaths from NCDs occur in the age group 30 - 70 years in our region and are considered premature. These diseases disproportionately affect the poor, robbing families of breadwinners and pushing them into a vicious cycle of poverty," said Dr Poonam Khetrapal Singh, regional director for WHO South-East Asia Region. "The millions of productive individuals lost prematurely to NCDs are seriously undermining social and economic development," she added. Increased lifespan and changes in people's lifestyles are accelerating the increase in NCDs and their common risk factors including tobacco use, unhealthy diet, inadequate physical activity and harmful use of alcohol. Globalization, trade liberalization, rapid unplanned urbanization, irresponsible marketing of junk foods, alcohol and tobacco, and increasing socioeconomic inequities are creating a milieu conducive to the rise in NCDs. This makes addressing NCDs a vital health as well as developmental imperative for countries in the region. 80 percent of heart diseases, strokes and type 2 diabetes and 30 percent of all cancers can be prevented by eliminating the most common NCD risk factors like tobacco and alcohol use, unhealthy diet and lack of physical activity. At the 65th World Health Assembly in 2012, Member States adopted a goal of reducing premature deaths from NCDs by 25 percent by 2025. To achieve these targets, WHO emphasizes the importance of implementing evidence-based, cost-effective interventions-the 'Best Buys'-to prevent and control NCDs. NCDs currently cost lower-and middle-income countries nearly $500 billion annually. In contrast, the total annual cost of implementing all of the 'Best Buys' to address NCDs is just $11.4 billion, with the added benefit of saving millions of lives. "Some examples of 'Best Buy' interventions for the prevention and control of NCDs include raising tax on tobacco and alcohol products, reducing salt consumption, eliminating trans-fat in the food supply chain, promoting physical activity and detecting and treating NCDs at an early stage," said Dr Khetrapal Singh. Although the health sector bears the brunt of NCDs, it has very little control over their root causes. "Wide-scale implementation of these 'Best Buys' requires coordinated action. Ministries of health as well as non-health ministries such as finance, transport, sports, education, agriculture, and food safety, among others, must work together. This requires the highest level of political commitment, resolve and response," urged Dr Khetrapal Singh. ]]> <![CDATA[CGI acquires genomic services firm BioServe India]]> https://biospectrumindia.com/news/95/6458/cgi-acquires-genomic-services-firm-bioserve-india.html https://biospectrumindia.com/news/95/6458/cgi-acquires-genomic-services-firm-bioserve-india.html Tue, 19 Aug 2014 16:33:10 +0530 DNA-based diagnostics company Cancer Genetics has announced the completion of its acquisition of the Hyderabad-based genomic services firm BioServe India. The company caters to both research and clinical markets. Earlier this year, the US-based firm had announced that it was buying BioServe for $1.9 million, largely through stock and other deferred considerations. The company will become a wholly owned subsidiary of Cancer genetics and will be renamed as Cancer Genetics India (CGI). While retaining the 33 employees of its Indian entity, Cancer plans to expand and strengthen the team. The diagnostics company plans to develop BioServe India's accredited laboratory into a center of excellence for biomarker analysis, next generation sequencing, and oncology diagnostics. It also plans to grow a pipeline of potential clients and collaborators for its non-invasive cervical cancer test, FHACT in India. Cervical cancer is the leading cause of cancer death in women in the country, accounting for 25 percent of global cervical cancer deaths. India is recognized as a high-growth market for molecular diagnostics and oncology services. "We are excited about oining Cancer Genetics," said Mr Venkatadri Bobba, general partner of Ventureast, India's premier venture capital fund and a board member at BioServe India. He added, "This merger will allow us to improve patient care in India by delivering cutting-edge, patented cancer diagnostic technologies and allow us to offer an even broader range of state-of-the-art services to biopharma customers, hospitals, and academic research institutions." CGI's chief executive officer Mr Panna Sharma said that the acquisition places the company in a unique position to meet the growing need for genomic-based cancer diagnostics in the market. He expects wide adoption of CGI's proprietary tests for non-Hodgkins lymphomas and leukemias, kidney and cervical cancer. In particular, the acquisition places CGI in a position of being able to revolutionize cervical cancer screening and treatment in India, where 123,000 new cases are diagnosed annually," he said. Mr Sharma described the Hyderabad laboratory as an important resource that will allow CGI to access high-growth markets for oncology diagnostics and reduce costs associated with product manufacturing, test development and genomic data analysis. ]]> <![CDATA[No Ebola case in India, health minister rules out reports ]]> https://biospectrumindia.com/news/95/5176/no-ebola-case-in-india-health-minister-rules-out-reports-.html https://biospectrumindia.com/news/95/5176/no-ebola-case-in-india-health-minister-rules-out-reports-.html Tue, 19 Aug 2014 11:40:40 +0530 Dr Harsh Vardhan, the union health minister, has expressed satisfaction with the infrastructure in place at all entry points to the country to detect people arriving with symptoms of Ebola Virus Disease (EVD). World Health Organization had sounded an international emergency on August 8 but before that the Minister had placed India's surveillance and tracking systems on full alert. "Till now, 12,257 passengers have been screened at various international airports. Several departments of the central government are working in tandem with state governments to ensure total surveillance. I personally inspected the arrangements at Bangalore International Airport on Thursday," the minister said. Reports appearing in some media about a Nigerian national having tested "positive" for EVD in New Delhi's Dr Ram Manohar Lohia (RML) Hospital have been denied by the minister. "Our vigilant officials did indeed send a person to RML Hospital. His blood samples were sent to National Centre for Disease Control (NCDC) and National Institute of Virology, Pune. We are assured that they tested negative and there is no cause for worry," Dr Harsh Vardhan said. The samples were subjected to Antigen Elisa and RT-PCR tests. In addition, scientists at the Pune facility carried out sequencing and all tests confirmed that the Nigerian national was free of the dreaded Ebola virus. Meanwhile, WHO has reported that worldwide 2,127 EVD cases have been detected till August 13 and the total fatalities is 1,145. ]]> <![CDATA[USFDA raises a red flag on fake Ebola treatment drugs]]> https://biospectrumindia.com/news/95/5167/usfda-raises-a-red-flag-on-fake-ebola-treatment-drugs.html https://biospectrumindia.com/news/95/5167/usfda-raises-a-red-flag-on-fake-ebola-treatment-drugs.html Tue, 19 Aug 2014 11:06:18 +0530 Since the outbreak of the Ebola virus in West Africa, the FDA has seen and received consumer complaints about a variety of products claiming to either prevent the Ebola virus or treat the infection. There are currently no FDA-approved vaccines or drugs to prevent or treat Ebola. Although there are experimental Ebola vaccines and treatments under development, these investigational products are in the early stages of product development, have not yet been fully tested for safety or effectiveness, and the supply is very limited. There are no approved vaccines, drugs, or investigational products specifically for Ebola available for purchase on the Internet. By law, dietary supplements cannot claim to prevent or cure a disease, said the organization in a statement. It also said that Individuals promoting these unapproved and fraudulent products must take immediate action to correct or remove these claims or face potential FDA action. According to the Center for Disease Control and Prevention (CDC), Ebola does not pose a significant risk to the US public. Unfortunately, during outbreak situations, fraudulent products that claim to prevent, treat, or cure a disease all too often appear on the market. The FDA monitors for these fraudulent products and false claims and takes appropriate action to protect consumers. Ebola is the cause of a viral hemorrhagic fever disease. Symptoms include fever, headache, joint and muscle aches, weakness, diarrhea, vomiting, stomach pain, lack of appetite, and abnormal bleeding. Symptoms of the virus can appear anywhere from two to 21 days after exposure, but is most commonly seen on days 8 to10. Ebola is spread through direct contact with the body fluids of an infected person, or with objects like needles that have been contaminated with the virus. People who do not show symptoms are not contagious. ]]> <![CDATA[US FDA approves Biogen's MS drug]]> https://biospectrumindia.com/news/95/5120/us-fda-approves-biogens-ms-drug.html https://biospectrumindia.com/news/95/5120/us-fda-approves-biogens-ms-drug.html Mon, 18 Aug 2014 15:05:39 +0530 The US food and Drug Administration (USFDA) has approved Biogen's multiple sclerosis (MS) drug, Plegridy (peginterferon beta-1a). The drug is for relapsing forms of MS, taken once every two weeks. The treatment, which has got the thumbs-up based on data from a 1,500-patient study, can be administered subcutaneously with a ready-to-use autoinjector or a prefilled syringe. Biogen quoted Mr Peter Wade, Mandell Center for Comprehensive Multiple Sclerosis Care and Neuroscience Research, as having said, "It is a compelling new treatment option for people living with MS that offers a proven safety profile, strong efficacy and an every two-week dosing schedule administered by an innovative delivery system". He added that as a treating neurologist, "I believe these attributes will appeal to MS patients who look for less frequent dosing with proven effectiveness". Though, the multiple sclerosis drug market has oral treatments, including Biogen's own Tecfidera (dimethyl fumarate), Plegridy is still expected to be a successful product thanks to its offering less frequent injections and it should also be less painful than the company's older blockbuster Avonex (interferon beta-1a) which is given intramuscularly. The European Commission approved the therapy last month. ]]> <![CDATA[Sun unit recalls Cephalexin capsules from US]]> https://biospectrumindia.com/news/95/4523/sun-unit-recalls-cephalexin-capsules-from-us.html https://biospectrumindia.com/news/95/4523/sun-unit-recalls-cephalexin-capsules-from-us.html Mon, 18 Aug 2014 12:29:03 +0530 A unit of Sun Pharma from India, Caraco Pharma has initiated the process of recalling multiple lots of its Cephalexin capsules from the US market. The US Food and Drug Administration (US FDA) had notified that the company had voluntarily recalled 3,40,553 units of 500 mg and 1,13,677 units of 250 mg bottles after it wrote a letter to the regulator in June under 'Class-II' classification. Reports explained that as per the US FDA, Class II recall is a one in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. Citing the reason for the recall, the US FDA said on its website, "These products are being recalled because they were manufactured with active pharmaceutical ingredients (APIs) that were not manufactured with good manufacturing practices." The company said that Cephalexin, used to treat some bacterial infections, is an antibiotic that belongs to the family of medications known as cephalosporins. Further, reports explained that the recalled drug bottles were manufactured by Sun Pharma in India and distributed by Caraco in the US. Some reports also pointed out that Caraco Pharmaceutical had recently initiated a recall of some lots of Venlafaxine Hydrochloride extended-release tablets from the US market for not meeting the drug release dissolution specifications under 'Class-II' classification. ]]> <![CDATA[Ebola scare: 10,194 passengers screened at airports since 10 August]]> https://biospectrumindia.com/news/95/5177/ebola-scare-10194-passengers-screened-at-airports-since-10-august.html https://biospectrumindia.com/news/95/5177/ebola-scare-10194-passengers-screened-at-airports-since-10-august.html Mon, 18 Aug 2014 12:27:00 +0530 Since its inception on August 10, 2014, 10,194 health cards of passengers from Ebola Virus Disease affected countries have been returned by the Immigration Department (151 on August 10; 497 on August 11 and 1034 on August 12; 1407 on August 13; 2146 on August 14; 2441 on August 15;1531 on August 16 and 1987 on August 17) to the Airport health officers in Delhi, Mumbai, Bengaluru, Chennai, Trivandrum, Kolkata, and Kochi. All these passengers have been screened at the concerned airports. The samples of two Nigerian nationals (aged 4 and 37) admitted on August 17th to Dr RML Hospital have tested negative. The Indian national admitted to Bhilai Hospital earlier has also tested negative in tests done at NCDC. The 79-year-old Nigerian national continues to be under observation at Dr RML Hospital. His test reports are awaited. The Quarantine cum Isolation Health Facility at the Delhi Airport has been made functional and all suspect cases detected at the Delhi Airport would be admitted to this facility. Since yesterday evening, 5 citizens of Indian origin aged 38 (M), 38(F), 7(M), 2 (F) and 31(F) have been admitted to this facility. All of them have been found negative for EVD in tests done at NCDC. The Integrated Disease Surveillance Program (IDSP) is tracking such passengers, the details of which are provided to them by the Airport Health Organization. Today, 90 passengers were enrolled for follow-up tests in their respective States through State IDSP units. As on date, a cumulative number of 267 passengers are being tracked. Most of them are in the States of Maharashtra, Kerala, and Tamil Nadu. The control room in the ministry of health and family welfare has received 557 calls since its inception on August 9th and only 17 calls were received in the past 24 hours. WHO has reported a total of 2127 cases and 1145 deaths (as on 13th August 2014) due to Ebola Disease from affected countries. ]]> <![CDATA[PPP, technology only solutions to meet healthcare challenge ]]> https://biospectrumindia.com/news/95/5091/ppp-technology-only-solutions-to-meet-healthcare-challenge-.html https://biospectrumindia.com/news/95/5091/ppp-technology-only-solutions-to-meet-healthcare-challenge-.html Mon, 18 Aug 2014 10:39:44 +0530 Inviting active industry participation to provide healthcare services in India, Dr Jagdish Prasad, director general - Health Services, ministry of health and family welfare, government of India said, "Industry should adopt one district in each state, upgrading medical facilities in District health centers and primary health centers to provide best possible quality healthcare services to the common man. He was addressing the CII Conclave on "NextGen Healthcare - Roadmap: Healthcare for All", organized by the Confederation of Indian Industry in New Delhi recently. Calling Public Private Partnerships as the only solution to vast prevailing disparity in healthcare, he appealed to the industry, cooperatives and NGOs for support, specifically in strengthening healthcare delivery systems, drug distribution, use of Information Technology (IT), latest technologies and enhanced pharma supply chain management. "We are ready to support you with funds, even in converting district hospitals into world class medical hospitals but the industry will have to ensure that proper delivery systems and a strengthened supply chain are available, so that the facilities and medicines reach the last person in the remotest areas", he further highlighted. Highlighting the solutions for this challenge, he called for "Integration of five key ministries i.e the ministry for rural development, women and child welfare, water, urban sanitation, education and health. Presently, we are all working in isolation of each other and do not know what the other ministries are doing. If these five ministries can drive coordinated campaigns and launch joint schemes, then we would be far better equipped to provide quality healthcare to each and every individual of this country." "This is because some of the challenges lie outside health-care policy. Two-thirds of the health problems can also be solved by providing safe drinking water and sanitation. Even if we concentrate on these basic facilities, we can control many waterborne and airborne infectious diseases", he added. "Each year 39 million people in India enter BPL category due to poor delivery of healthcare services. To confront this, the industry has to bypass the rules and regulations and bureaucratic bottlenecks to find innovative ways or build confidence with Chief Ministers and get MC regulations eased, to build world class hospitals and strengthen the healthcare delivery system in India. For this, the key is good intent and strong political will of the government", emphasized the DG. "I would even recommend altering the constitution to make healthcare, which is presently a state subject, a central subject. The state governments and bureaucracy are not as proactive as they should be. For example, we adopted and provided money to 238 districts out of total 730 odd districts to create special Cardiac clinics across India, but only 37 centers have come up so far, that too majorly in the south and very few in Rajasthan and Gujarat. None of the other northern states benefitted from this scheme. In the 12th five year plan, we have decided to develop 20 National Cancer Centers at a cost of Rs 120 crores" shared Dr Prasad. "Our ministry is also planning to open AIIMS in all states and create ideal healthcare centers across different states with world class standards at Rs 50 crore each and would ask state governments to replicate similar standards in others as well. We would soon launch a web portal and E mechanism for public health delivery like supply chain management, drug distribution and recognition, hospitals and available healthcare facilities for different diseases etc," further informed the DG. Dr (Prof) Ranjit Roy Chaudhary, principal advisor to the Hon'ble Health Minister, Government of India highlighted that " We would soon launch a scheme called 'Healthcare Assurance for all citizens' which would cover each and every citizen of the country. Presently, only 25 percent of our population is insured." "Further, we are also working towards providing transparency in drug manufacturing. We will soon launch a web portal for the citizens and manufacturers, where applications, registration and licenses etc can be easily done. In rural areas, we are planning to build teams of 2-3 people including Ayush practitioners, to whom we would provide a 1 year 'bridging course'. Use of IT for better healthcare is also high on the agenda of the new government," informed Mr Chaudhary. "Though the share of Healthcare sector has increased from 0.9 percent to 2.5 percent of GDP in the 12th Five Year Plan, but it is still far low as compared to other countries, considering the diverse challenges of our vast country. For example, US spends 20 percent of its GDP on healthcare. Hence, we need the support of all stakeholders like the Industry, NGOs, cooperatives etc. Industry presently spends 70 percent of the total spend on healthcare while government spends 30 percent. What we also need is the maximum utilization of the funds", Mr Chaudhary furtehr said. "It is very disheartening that still, 45 percent of the Indian children are malnourished, our mothers are anemic, our villages have poor hygiene, while around 400 million abject poor are deprived of any healthcare services in India. Hence, we need to gear up our healthcare delivery mechanisms and for this, partnership is the only solution. There is a $160 billion untapped potential in healthcare including hospitals, pharmaceuticals and delivery systems etc in India, which the industry can really benefit from. With latest technologies, we can reach out to even the last man in the remotest area in the present day Digital India, since 900 million people in India are accessible through mobile phones while another 120 million through internet", Mr Harpal Singh, chairman, CII NextGen Healthcare Conclave and past chairman, CII NR. "Some key issues that need to be addressed include lack of infrastructure and manpower, inaccessibility of healthcare services, shortage of medical specialists and inefficiency of public healthcare providers. Though, in major urban areas, healthcare is of adequate quality and accessible, but its access is limited or unavailable in most rural areas and Tier II and Tier III cities, for which technology and partnership are the answer", said Mr Shreekant Somany, deputy chairman, CII Northern Region and chairman and managing director, Somany Ceramics Ltd. ]]> <![CDATA[FAPA: Indian pharma to strengthen in biosimilars era]]> https://biospectrumindia.com/news/95/5009/fapa-indian-pharma-to-strengthen-in-biosimilars-era.html https://biospectrumindia.com/news/95/5009/fapa-indian-pharma-to-strengthen-in-biosimilars-era.html Sat, 16 Aug 2014 12:35:00 +0530 The Federation of Asian Pharmaceuticals Association (FAPA) said that the upcoming patent cliff will be advantageous for Indian drug makers as biosimilars are all set to make a big entry into global markets. Mr John P Chang, president, FAPA, said that Indian biologics and biosimilars were indispensable imports for the companies in the Southeast Asian regions. Mr Chang mentioned that India was a valuable asset to the global pharmaceutical market, and that Southeast Asian markets looked up to Indian expertise. He said that there was an increased demand for Indian pharma experts in Southeast Asian companies. Mr Chang added that if India enhances its brand building exercise to leverage and tap the Southeast Asian markets, the country could be a major player in biosimilars and biologics. He noted that many of the vaccines sourced by WHO were from Indian companies. According to research done by the Decision Resources Group, many global players including India have around 57 biosimilars in clinical trials. With Novartis and Celltrion taking baby steps to augment biosimilars in the US, many drug makers are closely watching the progress and are targeting blockbuster drugs to cash in on the worldwide demand for life saving biologics. (Source: pharmabiz) ]]> <![CDATA[Uniform procedures for regulatory inspection:DCGI]]> https://biospectrumindia.com/news/95/5007/uniform-procedures-for-regulatory-inspectiondcgi.html https://biospectrumindia.com/news/95/5007/uniform-procedures-for-regulatory-inspectiondcgi.html Sat, 16 Aug 2014 12:29:00 +0530 The drugs controller general of India (DCGI) has issued new rules in order to ensure uniform implementation of regulatory inspection procedures for issuance of CoPP and other GMP certificates by both the state drug authorities and the CDSCO. According to the new procedures, all GMP inspections including that of CoPP will be focussing mainly on the requirements of Schedule M of Drugs and Cosmetics Rules, 1945 with respect to establishing shelf life, conducting validation studies, and ensuring prompt and effective recall besides WHO GMP requirements. Also, it has to be ensured that inspections are conducted for two-five days depending on the size of the manufacturing unit, the number of products handled, complexity of products, and procedures. The Inspection team shall prepare an inspection plan, conduct opening meetings and exit meetings on the final day to summarize and discuss the observations with the manufacturers. In case of critical observations which have a direct impact on the quality, safety, and efficacy of the product and where regulatory action has to be initiated immediately, reports have to be finalized at the end of the inspection without delay. The final report of inspection may be finalized within a week, critically reviewed by zonal officers and forwarded to the respective state licensing authorities for necessary action, along with a copy to CDSCO (HQ) and manufacturers for compliance, if any. Similarly, the state drug control authorities shall also initiate the process that qualifies inspectors for inspection of vaccines and pharmaceutical manufacturing facilities based on experience and training.They will ensure that each inspector carries out a minimum of five GMP inspections in one year to sustain the performance. The inspection of medicines and biologicals should be conducted using risk-based approach and should specifically focus on product development, product quality attributes and stability studies conducted to establish the shelf life in Indian climatic conditions, process validation, complaints/recalls, handling of out of specifications deviations, change control procedures, aseptic processing and sterilization. ]]> <![CDATA[Aspirin can reduce cancer risk: Study]]> https://biospectrumindia.com/news/95/4995/aspirin-can-reduce-cancer-risk-study.html https://biospectrumindia.com/news/95/4995/aspirin-can-reduce-cancer-risk-study.html Sat, 16 Aug 2014 10:32:00 +0530 An aspirin a day could dramatically cut people's chances of getting and dying from common cancers, according to recent research. A research team led by Professor Jack Cuzick, head of the center for cancer prevention at Queen Mary University of London, concluded that people between 50 and 65 years should consider taking 75mg low-dosage tablets of aspririn regularly. Prof. Cuzick said that taking aspirin "looks to be the most important thing we can do to reduce cancer after stopping smoking and reducing obesity, and will probably be much easier to implement." Aspirin was originally developed as a painkiller and a treatment for fever and inflammation, but more than a century after it was first synthesized from a Willow bark tree, researchers have found many medical uses for it.It has demonstrated its effectiveness in reducing the risk of heart attacks and strokes as well as the chances of occurence of some cancers. But the big question has been whether the benefits outweigh the harm, because aspirin can cause stomach bleeds, which could be potentially fatal in some people. The study published in the journal Annals of Oncology, revealed that by taking low-dose aspirin every day for ten years, bowel cancer cases were cut by about 35 percent and deaths by 40 percent. Aspirin could reduce rates of oesophageal and stomach cancers by 30 percent and death from them by 35 percent to 50 percent. He said people considering embarking on a regime of daily aspirin should talk to their GP and get tested for potential risks first. All the cancers in which aspirin has a beneficial effect have some lifestyle causes - from smoking in lung cancer to alcohol in oesophageal cancer and obesity in all of them. Taking aspirin, said Mr Cuzick, "should not be seen as a reason for not improving your lifestyle". The drug, however, could reduce cancer risk even in people who have a healthy lifestyle, he said. However, Cancer Research UK (CRUK) warned that people should speak to their GP before starting a daily dosage. The charity said it would like to see more research on who should and should not be taking it. "Aspirin is showing promise in preventing certain types of cancer, but it's vital that we balance this with the complications it can cause - such as bleeding, stomach ulcers, or even strokes in some people," said Dr Julie Sharp, head of health information at CRUK. "Before aspirin can be recommended for cancer prevention, some important questions need to be answered, including what is the best dose and how long people should take it for. And tests need to be developed to predict who is likely to have side-effects. Given the continued uncertainty over who should take aspirin, Cancer Research UK is funding a number of trials and research projects to get a clearer picture," she said. ]]> <![CDATA[Experts want One Health strategy for humans, animals]]> https://biospectrumindia.com/news/95/4934/experts-want-one-health-strategy-for-humans-animals.html https://biospectrumindia.com/news/95/4934/experts-want-one-health-strategy-for-humans-animals.html Fri, 15 Aug 2014 12:18:00 +0530 For every human on earth, there are almost four domesticated animals. On our increasingly crowded planet, most humans are living in closeproximity with a variety of livestock such as cattle, goats, pigs and horses. And we are exchanging our diseases freely with each other which is becoming a major health hazard. So why not look at such diseases from the perspective of both humans and animals and find common solutions? Many people around the world have been asking these questions. And they have now come to the conclusion that we need a One Health policy, that "integrates expertise from human, animal and environmental health using biomedical science, epidemiology, economics, ecology and social sciences." So experts from around the world converged in mid-July at Hyderabad to tackle these common issues head-on at an International Conference on Host-Pathogen Interactions. Organized by the publicly-funded National Institute of Animal Biotechnology (NIAB), it was hosted bythe University of Hyderabad (UOH). NIAB is located on the UOH campus.Outlining the emerging concept of One Health, Dr Purvi Mehta, head-Asia, International Livestock Research Institute (ILRI) of the UN system, New Delhi, said there are some 24 billion livestock in the world and over a billion people, mostly in the developing countries, are depended on them for their livelihoods. Though there are dozens of diseases that emanate from animals, zoonoses as they are called, 13 of these wreak havoc affecting about 2.4 billion people annually. These zoonoses claim about 2.2 million lives a year and kill 12-14 percent of the livestock population. Dr Mehta said experts have estimated that the world suffered losses of more than $80 billion due to zoonotic diseases between 1998 and 2009.In fact, the 2002-04 SARS (Severe Acute Respiratory Syndrome) that originated from fruit bats, civets and then spread to animals and humans alone cost the world more than $40 billion and six other diseases such asWest Nile Fever, NIPAH virus, Rift Valley Fever made the world poorer by another $40 billion in lost economic output and unnecessary treatment costs, according to estimates by the World Bank. What is more alarming now is the fact that almost 60 percent of human diseases are shared with animals. And nearly 75 percent of all the emerging infectious diseases are zoonotic in nature. Dr Girish Sohni, a public health expert, revealed that in India no joint surveillance on zoonotic diseases are done systematically. Most health surveys focus on animals or humans separately. For example, the antigen used to test for tuberculosis in humans in available in plenty. But there is no specific TB antigen for animals. TB outbreaks are reported routinely from among animals in many regions and even in zoo enclosures. Very little is done to study and control these outbreaks. Many experts, who spoke at the conference, called for interdisciplinary co-operation and setting up of joint mechanisms to tackle these emerging zoonotic diseases on a war-footing. A National One Health policy is the need of the hour, experts said. ]]> <![CDATA[Allied Minds and BMS form new enterprise ]]> https://biospectrumindia.com/news/95/4942/allied-minds-and-bms-form-new-enterprise-.html https://biospectrumindia.com/news/95/4942/allied-minds-and-bms-form-new-enterprise-.html Sat, 16 Aug 2014 12:11:00 +0530 The enterprise has been created to identify and foster research and pre-clinical development of biopharmaceutical innovations from leading university research institutions across the US. Allied-Bristol Life Sciences will focus on efficiently and effectively converting discoveries from university research institutions into therapeutic candidates for clinical development, and ultimately approved therapies that address serious diseases. "Allied-Bristol Life Sciences brings together cutting-edge ideas, BioPharma experience and drug discovery expertise focused on maximizing the potential of new scientific approaches to addressing serious diseases," said Mr Carl Decicco, senior vice president and head, discovery, Bristol-Myers Squibb. "We believe this new venture will enhance the translation of early-stage academic research and will ultimately help advance important potential new medicines more efficiently." For programs identified by the new enterprise, university researchers will be able to access Bristol-Myers Squibb's drug discovery research expertise, and Allied Minds' financial and management experience. "The innovations developed in US research institutions represent an important resource for scientific advancement, as well as economic development and financial returns," said Mr Chris Silva, CEO, Allied Minds. "Our partnership with Bristol-Myers Squibb combines complementary strengths, resources, reach and expertise to create an exciting new paradigm in the drug development space." Under the terms of the agreement, the companies have jointly formed and funded Allied-Bristol Life Sciences, which will work with university researchers to identify discoveries it believes have promising therapeutic and commercial potential, and will support the research and development needed to take these early-stage opportunities from initial feasibility to pre-clinical candidacy. Allied Minds and Bristol-Myers Squibb together will form and fund new companies to conduct feasibility and full-phase discovery programs. Once a program succeeds in identifying a pre-clinical candidate, Bristol-Myers Squibb will have the option to acquire the company from Allied-Bristol Life Sciences under pre-agreed terms. ]]> <![CDATA[Merck's insomnia drug gets USFDA approval]]> https://biospectrumindia.com/news/95/4870/mercks-insomnia-drug-gets-usfda-approval.html https://biospectrumindia.com/news/95/4870/mercks-insomnia-drug-gets-usfda-approval.html Thu, 14 Aug 2014 16:45:30 +0530 Merck got the US Food and Drug Administration (USFDA) nod for its insomnia drug Belsomra. It is an orexin receptor antagonist is the first approved drug in that class. It regulates the sleep-wake cycle by altering the action of the neurotransmitter in the brain. Belsomra has been approved in four different strengths - 5, 10, 15, and 20 mg. The FDA has recommended that Belsomra be categorised as a controlled substance (schedule IV) because it can be abused or lead to dependence. It will be dispensed with an FDA-approved medication guide once a final decision on scheduling is made by the US Drug Enforcement Administration. Merck has said that Belsomra should be available by late 2014 or early 2015. The recommended dosage for the drug is 10mg, taken no more than once per night and within 30 minutes of going to bed, and at least seven hours before the planned wake up time. Mr David Michelson, head of neurosciences at Merck Research Laboratories, said, "Belsomra is the result of more than a decade of study and provides tangible evidence of our long-standing commitment to innovation". He added that the approval allows for the introduction of a new treatment option for patients suffering from insomnia. ]]> <![CDATA[CSIR files 562 patents in 2013-14]]> https://biospectrumindia.com/news/95/4865/csir-files-562-patents-in-2013-14.html https://biospectrumindia.com/news/95/4865/csir-files-562-patents-in-2013-14.html Thu, 14 Aug 2014 16:39:02 +0530 As per the union minister of state for science and technology, Dr Jitendra Singh in a written reply in Lok Sabha on August 13, 2014, "There has not been any slowdown in the research fields in science and technology in recent years." Explaining his point, the minister said, "Citation impact of papers, measured as a qualitative parameter in research, has increased from 0.35 to 0.68 in 2006-10 period, relative to 1981-85. There is a 81 percent increase in the number of highly cited papers during 2006-10 relative to 2001-05 (4,723 highly cited papers in 2006-10 as against 2,610 in 2001-05)." The patents filed by the Council of Scientific and Industrial Research (CSIR) in India and abroad have risen from 340 in 2009-10 to 562 in 2013-14. India's position globally in the field of scientific research and development, as measured by the number of research papers published, has improved from 13th position in 1996 to 9th position in 2010 as per the Scopus International database. In case of research in chemistry, India ranks 5th in the world with respect to scientific publications. India is placed 3rd in the world in terms of scientific publications in Nanoscience and Nanotechnology and figures among the top ten countries in terms of h-index. These figures indicate that India is progressing both in terms of quality and quantity in research in S&T. The ministry has established a "National Center for Molecular Materials Research" at Thiruvananthapuram during the last 3 years and is proposing the establishment of a "National Center for Himalayan Glaciology" at Mussoorie, Uttarakhand. ]]> <![CDATA[Roche to acquire Santaris for developing RNA-targeting medicines]]> https://biospectrumindia.com/news/95/5232/roche-to-acquire-santaris-for-developing-rna-targeting-medicines.html https://biospectrumindia.com/news/95/5232/roche-to-acquire-santaris-for-developing-rna-targeting-medicines.html Thu, 14 Aug 2014 15:30:07 +0530 Under the terms of the agreement, Roche will make an upfront cash payment of $250 million to Santaris Pharma shareholders and make additional contingent payments of up to $200 million based on the achievement of certain predetermined milestones. "Today there are many disease targets that are very challenging or even impossible to reach with small molecules or antibodies," said Mr John C Reed, head, Roche Pharma Research and Early Development. "We believe the LNA platform provides the means to efficiently discover and develop an important new class of medicines that may address the significant needs of patients across multiple therapeutic areas." Santaris Pharma has pioneered its proprietary Locked Nucleic Acid (LNA) platform that has contributed to an emerging era of RNA-targeting therapeutics. This new class of medicines has the potential to address difficult to treat diseases in a range of therapeutic areas. "Roche and Santaris have complementary capabilities that will help us realize breakthrough medicines," stated Mr J Donald deBethizy, president and CEO, Santaris Pharma. "The acquisition combines Santaris Pharma's next-generation antisense technology and LNA expertise with Roche's deep experience in disease biology, chemistry, drug safety, drug formulation, delivery, and development." The acquisition, which is subject to customary closing conditions, is expected to close in August 2014. Roche plans to maintain Santaris Pharma's operations in Denmark, where the existing site will be renamed Roche Innovation Center Copenhagen. ]]> <![CDATA[Sales growth slows down for Novozymes]]> https://biospectrumindia.com/news/95/4864/sales-growth-slows-down-for-novozymes.html https://biospectrumindia.com/news/95/4864/sales-growth-slows-down-for-novozymes.html Thu, 14 Aug 2014 15:04:56 +0530 Organically, its sales grew by 8 percent (4 percent DKK, 8 percent LCY). However, sales growth slowed down during the period after a strong first quarter, and due to a higher comparable level in the second quarter. EBIT grew by 19 percent, and the EBIT margin increased by 3.5 percentage points to 28.1 percent. The higher EBIT margin was driven by a one-time positive impact of roughly 2 percentage points from The BioAg Alliance and a significant improvement in underlying earnings. Also, Novozymes had a strong free cash flow at DKK 3,417 million due to the positive one-time impact from The BioAg Alliance and a relatively low level of CAPEX in the period. The full-year sales growth outlook is maintained said the statement.Full-year expectations for EBIT and net profit growth are increased to 9-11 percent, up from 8-10 percent. Expectations for ROIC, including goodwill, are adjusted to ~22 percent, up from 21-22 percent. Lastly, expectations for free cash flow were revised upward by DKK 500 million, mainly as a result of lower expectations for net investments and a higher positive impact from The BioAg Alliance. ]]> <![CDATA[Evaluation of progress on 'Brucellosis' underway ]]> https://biospectrumindia.com/news/95/4886/evaluation-of-progress-on-brucellosis-underway-.html https://biospectrumindia.com/news/95/4886/evaluation-of-progress-on-brucellosis-underway-.html Thu, 14 Aug 2014 14:49:11 +0530 Review Workshop of DBT sponsored 'Network Project on Brucellosis' was organized jointly by Sardarkrushinagar Dantiwada Agricultural University (SDAU), Gujarat and National Institute of Veterinary Epidemiology and Disease Informatics (NIVEDI), Bengaluru at Ahmedabad on 8th August, 2014. While inaugurating the workshop, the chief guest, Mr Babubhai B Bokhiriya, Minister for Agriculture, Co-operation, Water Resources, Water Supply, Animal Husbandry, Fisheries, and Cow Breeding, Govt. of Gujarat, expressed his gratitude to DBT and NIVEDI for organizing the meet in Gujarat and assured them that all possible help will be extended in prevention and control of livestock diseases including Brucellosis in Gujarat. Dr H Rahman, project coordinator and director, NIVEDI briefed the gathering on the activities being carried out for the implementation of the Brucellosis Control program in the country. He highlighted the impact of animal health in general and Brucellosis in particular on the economy, livelihood and food security of the country. Dr S R Rao, advisor, DBT emphasized the need for the control of brucellosis and urged state officials to implement the Brucella-Free village concept, which can be replicated in other parts of country in the near future. Prof. Ashok A Patel, vice-chancellor, SDAU appreciated the efforts being made by DBT in grooming young professionals who would be contributing to a better tomorrow. He assured all support and encouragement to the group working in his university. Earlier, Dr N M Shah, dean, Veterinary Faculty, SDAU welcomed the dignitaries and participants from different parts of the country. Dr N C Patel, vice-chancellor, Anand Agricultural University, Dr H N Kher, director, HRD and registrar, SDAU and Dr R R Shah, director of research and dean PG Studies, SDAU also shared their views. The present scenario of Brucellosis disease, prevention and control measures in the country were reviewed. Scientists and Researchers from ICAR institutes, State Agricultural University (SAU), State Veterinary University (SVU) and industries from 12 states participated in the workshop. Prof. B S Chandel, head, Department of Animal Biotechnology, SDAU proposed the vote of thanks. (Source: National Institute of Veterinary Epidemiology and Disease Informatics, Bangalore) ]]> <![CDATA[Funds for pharma research taken care of says govt]]> https://biospectrumindia.com/news/95/4866/funds-for-pharma-research-taken-care-of-says-govt.html https://biospectrumindia.com/news/95/4866/funds-for-pharma-research-taken-care-of-says-govt.html Thu, 14 Aug 2014 14:03:00 +0530 As per the information revealed by the union minister of state for science and technology, Dr Jitendra Singh, the government provides soft loans to Indian Pharma industries including small scale for research and development (R&D) activities, which includes support for instruments under the Drugs and Pharmaceutical Research Program of the Department of Science and Technology (DST). The government also provides partial support for pilot plant equipment and machinery, including specialized equipment to industry, small scale units in any sector, the pharmaceutical sector for development and demonstration of innovative technologies through the PACE (Patent Acquisition and Collaborative Research and Technology Development) scheme of the Department of Scientific and Industrial Research (DSIR). The S&T minister spoke about Biotechnology Industry Research Assistance Council (BIRAC), a public sector undertaking of the Department of Biotechnology (DBT). Innovative Research is funded in startup's and SME's in the Biotech sector, which also includes pharma units for developing affordable health care products. The innovative research component includes some equipment which are required for research activities. The Department of Science and Technology under the Ministry of Science and Technology has been implementing a Plan Scheme (Drugs and Pharmaceuticals Research Program - DPRP) since 1994-95 for promoting R&D in the Drugs and Pharmaceutical sector with the objective to synergise the strengths of publicly funded R&D institutions and Indian Pharmaceutical Industry; create an enabling infrastructure, mechanisms and linkages to facilitate new drug development; stimulate skill development of human resources in R&D for drugs and pharmaceuticals; extend soft loans to Pharma industrial R&D projects; and enhance the nation's self-reliance in drugs and pharmaceuticals especially in areas critical to national health requirements. Under this program as on 13th August, 2014, 110 industries - institutional alliances both in modern and Indian systems of medicine including veterinary drugs have been funded. The program has supported R&D projects on Tuberculosis, Malaria, Diarrhoea, Filariasis, Diabetes, Psychosomatic disorders, Kala Azar, Cataract, Cancer, Dementia, HIV/AIDS, Anti Fungal, Anti Virals, Anti Cancer, Anti Bacterial, Anti Rabies, Anti Obesity, Anti Asthma, Arthritis, Anti Amoebisis etc.; vaccines for Dengue, Japanese Encephalitis, Hepatitis-B etc. 48 state-of-the art infrastructure for Pharmaceutical R&D has been created in different premier institutions and Universities on Bio-availability, Pharmakoinformatics, Regulatory Toxicology, Safety Pharmacology at NIPER, Mohali; Pharmacokinetic and Metabolic Studies, Regulatory Pharmacology and Toxicology, Medium Throughput Screening at CDRI, Lucknow; Transgenic and Gene Knockout Mice, Clinical Research facility to Stem Cell Technologies and regenerative medicine, Biosafety Level 4 Laboratory at CCMB, Hyderabad; Bioequivalence, Pharmacovigilance, New Chemical Entities development, Animal Facility for Indian System of Medicine etc. have been created in other Universities and Institutions. Since 2004-05, the program has extended 73 soft loans for Indian Pharma Industry R&D projects at a simple interest rate of 3 percent per annum with repayment duration of 10 years. Also from 2008-09, the program supported three grants-in-aid projects to Indian Pharma industries for conducting clinical trials in neglected diseases such as malaria, kala-azar, etc. The Department of Scientific and Industrial Research (DSIR) launched a scheme in the 12th five year plan - PRISM (Promoting Innovations in Individuals, Start-ups and MSMEs) where it has proposed to support innovative projects in MSMEs, including those in the pharmaceutical sector, through public funded R&D institutions including national laboratories. The Department of Biotechnology (DBT) is encouraging the Indian Biotechnology Industries to participate in research projects in collaboration with academic institutions. The calls for proposals are regularly issued for strengthening the SME's both at national and international levels. The Department of Science and Technology (DST) has set up Sophisticated Analytical Instrument Facilities (SAIFs) in different parts of the country to provide sophisticated analytical instrument facilities to research workers in general and specially to institutions which do not have such instruments through its Sophisticated Analytical Instrument Facilities (SAIF) program. This enables them to pursue R&D activities requiring such facilities and keep pace with developments taking place globally. The SAIFs are equipped with sophisticated analytical instruments to meet the needs of research workers in various areas of science and technology. The instrument facilities at the SAIFs are accessible to all users and are being used extensively by researchers from all parts of the country. These facilities are being used by small scale pharma units also. ]]> <![CDATA[An alternative to Adiponectin]]> https://biospectrumindia.com/features/95/5679/an-alternative-to-adiponectin.html https://biospectrumindia.com/features/95/5679/an-alternative-to-adiponectin.html Wed, 13 Aug 2014 16:40:25 +0530 Adiponectin is a hormone which regulates glucose and fat metabolism. More than 12500 scientific reports have been published on this molecule. A large number of clinical studies have already established that the plasma level of this hormone is diminished in multiple diseases like insulin resistance, obesity, type II diabetes, cardiovascular diseases and even cancers. Yet, replenishing this hormone because Adiponectin is a pretty large peptide. Monomeric (single molecule) adiponectin's molecular weight is about 30kda. On top of that adiponectin oligomerize and complexity regarding adiponectin is heightened by the fact that each oligomer can have distinct functions. Therefore, first producing such a big peptide in the laboratory, followed by its proper oligomerization is logistically impossible, explains Dr Sabayasachi Sanyal, principal scientist, Central Drug Research Institute (CDRI), Lucknow. The medical world was looking for a small molecule which could mimic the action of this hormone. GTDF is the abbreviation form of (2S,3S)-(+)-3',4',5,7-tetrahydroxydihydroflavonol-6-C-Î²-D-glucopyranoside, the chemical name of a novel compound that was isolated from the stem bark of the Himalayan Elm (Ulmus wallichiana) by CSIR-CDRI medicinal chemist Dr Rakesh Maurya and team and is now being synthesized in laboratory. Dr Sanyal and his team has discovered it as an adiponectin-mimicking molecule. Speaking about its discovery, He said, "Mr Chattopdhyay at CSIR-CDRI, where it was found to enhance survival, proliferation, differentiation and mineralization of osteoblast cells that are responsible for forming bone. We had a lucky break, while studying its effect on secondary (steroid-induced) osteoporosis, where its effect was being studied on dexamethasone (a synthetic glucocorticoid)-induced bone loss. In our model a high dose of dexamethasone was used, at this dose dexamethasone not only induces bone loss, it also leads to death of animals after two weeks and amazingly the animals that were co-treated with GTDF were not only alive, they were as healthy as the control rats who did not receive dexamethasone. We therefore not only compared the bones in these animals but also checked for other phenotypic changes and found that among various effects, GTDF completely rescued these animals from dexamethasone-induced insulin-resistance." Identification of GTDF as a small adiponectin mimetic molecule is of paramount importance and is considered as an important therapeutic tool for the treatment of metabolic diseases caused by adiponectin deficiency. The findings of the study are published in American journal of associations' journal Diabetes. ]]> <![CDATA[Eminent Indian Scientist Dr S Ayyappan honoured ]]> https://biospectrumindia.com/news/95/4819/eminent-indian-scientist-dr-s-ayyappan-honoured-.html https://biospectrumindia.com/news/95/4819/eminent-indian-scientist-dr-s-ayyappan-honoured-.html Wed, 13 Aug 2014 15:25:51 +0530 On the occasion of the birth anniversary of Late Rai Bahadur Gujar Mal Modi, the Hon'ble Agriculture Minister of India, Mr Radha Mohan Singh today awarded the 'Gujar Mal Modi Award for Innovative Science and Technology 2014' to Dr Ayyappan. This award recognizes his immense contribution to the field of Fisheries, Freshwater Aquaculture and Aquatic Microbiology. Dr Ayyappan is credited with bringing Indian Fisheries to a level of excellence in basic science and fish commercialization, unmatched anywhere the world. He is currently the secretary, Department of Agricultural Research and Education, DARE and director general, Indian Council of Agricultural Research, ICAR. The minister Mr Radha Mohan Singh said,"I appreciate the efforts of Gujar Mal Modi Foundation in recognizing the dedication and hard work of scientists. It gives me great pleasure in congratulating Dr Ayyappan on receiving this award and for his achievements in the field of Fisheries, Freshwater Aquaculture and Aquatic Microbiology." Mr SK Modi, president of the GM Modi Foundation commented, "Under leadership of Dr S Ayyappan the agricultural research and education programs in our country have received a new direction. His specific areas of research in Fisheries, Freshwater Aquaculture and Aquatic Microbiology are a source of inspiration to the entire young generation of scientists. We, at The Gujar Mal Modi Science Foundation feel honored to recognize such invaluable research of our distinguished scientists and will be committed to carrying forward our efforts and dedication on bringing to light such achievements." ]]> <![CDATA[CDRI's wonder molecule]]> https://biospectrumindia.com/features/95/4821/cdris-wonder-molecule.html https://biospectrumindia.com/features/95/4821/cdris-wonder-molecule.html Wed, 13 Aug 2014 14:56:00 +0530 GTDF is a novel compound, isolated from the bark of the Himalayan Elm (Ulmus wallichiana) by CDRI medicinal chemist Dr Rakesh Maurya and team, is now being synthesized in laboratory. It was discovered as an adiponectin-mimicking molecule by CDRI scientist Dr Sabayasachi Sanyal and his team. It's an orally active molecule that improves metabolic parameters in a preclinical disease setting and holds therapeutic promise in metabolic diseases caused by Adiponectin deficiency. Adiponectin is a hormone which regulates glucose and fat metabolism. A large number of clinical studies have already established that the plasma level of this hormone is diminished in multiple diseases like insulin resistance, obesity, type 2 diabetes, cardiovascular diseases, and even cancers. However, there are some logistic problems for its manufacturing at the laboratory. As lifestyle diseases are a major threat, this discovery could pave the way for the treatment of these diseases. The currently available options are only for their management. Thus, the discovery of GTDF as an orally active adiponectin is of paramount importance, said Dr Sanyal in an interview with BioSpectrum. The study was conducted with Sanjay Gandhi Post-graduate Institute of Medical Sciences (SGPGI) and Zydus research Center on an academic collaboration basis. "However, this is still at a nascent stage, it will require a lot of research and funding before it is finally available in the market," said Dr Sanyal. He further mentioned that in future they plan to study the effects of GTDF on each individual organ and its other potential benefits as well as conduct detailed toxicology and safety pharmacology studies along with pharmacokinetics in large animals. "We are looking for willing industrial partners for this particular aspect of our study", he concluded. ]]> <![CDATA[GTDF: A promising therapeutic tool for lifestyle diseases]]> https://biospectrumindia.com/features/95/4823/gtdf-a-promising-therapeutic-tool-for-lifestyle-diseases.html https://biospectrumindia.com/features/95/4823/gtdf-a-promising-therapeutic-tool-for-lifestyle-diseases.html Wed, 13 Aug 2014 14:31:00 +0530 Dr Sabayasachi Sanyal, principal scientist, CDRI and their team have discovered an adiponectin-mimicking molecule which can cure metabolic disorders caused due to adiponectin deficiency. Adiponectin is a hormone which is involved in regulating glucose levels as well as fatty acid breakdown. Levels of the hormone are inversely correlated with body fat percentage in adults. Dr Sanyal explained, "type II diabetes being a "sugar disease", is as much a "fat disease", where elevated blood level of glucose and lipids including cholesterol, triglyceride, LDL, and free fatty acids play an enormously important role in the pathology of this disease." In this context, he elaborated on the therapeutic promises of GTDF. One of the major advantages with this compound lies in its ability to convert white adipose tissue to brown adipose. Brown adipose are present at negligible levels in adult humans and are metabolically highly active. The brown adipose tissue has a high capacity to burn fat inside them by an enzymatic process called beta oxidation, and is particularly useful for non-shivering thermogenesis during cold. Thus, conversion of white adipose to brown adipose necessarily burns fat inside the tissue and the fatty acid load in the circulation goes down. That GTDF, in addition to lowering total cholesterol, frees fatty acids and triglycerides elevates the good cholesterol HDL indicates a drastically favorable shift in a lipid profile. This is beneficial for both type 2 diabetes and overall cardiovascular health. GTDF protects pancreatic beta cells from diabetic stress induced death and improves insulin-secretion. It enhances the capacity of skeletal muscles to use fat as a source of energy, thereby causing efficient utilization of excess fat. GTDF thus essentially mimics the beneficial effects of endurance exercise (like marathon running). ]]> <![CDATA[FDA okays only 25 new biotech drugs in 2013]]> https://biospectrumindia.com/views/95/4817/fda-okays-only-25-new-biotech-drugs-in-2013.html https://biospectrumindia.com/views/95/4817/fda-okays-only-25-new-biotech-drugs-in-2013.html Wed, 13 Aug 2014 14:27:20 +0530 After a high of 33 approvals in 2012, the US regulator FDA gave its nod to only 25 new drugs in 2013. FDA also approved just two biological licenses (BLA) last year, according to data compiled by the annual Global Biotechnology Report by EY. The report was released at the annual BIO International Convention in San Diego, USA, in June. The highest annual drug approvals in recent decades happened in 1996 when US FDA approved 53 drugs. Otherwise, the annual average approvals have hovered around 24.Releasing the report, EY's Global Life Science Practice leader, Mr Glen Gionavetti, noted that among the 25 new drugs approved in 2013, two are already on the way to become blockbusters with annual sales topping $1 billion. Gilead Sciences got a lucky winner in Sovaldi, which got approved very late in 2013. Its sales in the first quarter of 2014 itself has topped $2 billion. Sovaldi is an interferon-free oral treatment to contain Hepatitis C infection. Biogen Idec hit the blockbuster jackpot with Tecfidera, an oral therapy to treat relapsing forms of multiple sclerosis. Both Tecfidera and Sovaldi are biotech drugs.EY report said there are three other promising biotech drugs which got approved in 2013. These are: Ibruvica, developed by Pharmacylcis in partnership with Johnson & Johnson, Opsumit by Actelion and Pomalyst from Celgene. Ibruvica and Pomalyst are anti-cancer drugs. Ibruvica is used to treat mantle cell lymphoma cancer condition and also chronic lymphocytic leukemia. Pomalyst is successful in treating another form of cancer called multiple myeloma. Opsumit is used to reduce the effect of pulmonary hypertension (high blood pressure) in adults, which if untreated leads to lung collapse.EY said companies took advantage of FDA's expedited review process for Breakthrough Therapy and got approvals faster. In fact, more than half the 25 drugs approved last year came through some of FDA's new fast track approval process. Overall GSK was the table topper getting five new biotech drugs approved in 2013. These include Mekinist and Tafinlar, both anti-cancer drugs, Trivacy, an anti-HIV treatment method developed through Viiv Healthcare. EY said biotech companies have played a key role in the approval of many other drugs such as cancer treatment Kadcyla which used an important technology from biotech company Immunogen. Prostate cancer medicine Xofigo by Bayer Healthcare was developed by biotech company Algeta. In fact Bayer bought Algeta for this drug. Overall one-third of the 25 new drugs approved were to treat some forms of cancer. ]]> <![CDATA[Toxicity in Tea: Study]]> https://biospectrumindia.com/news/95/4761/toxicity-in-tea-study.html https://biospectrumindia.com/news/95/4761/toxicity-in-tea-study.html Tue, 12 Aug 2014 16:11:39 +0530 According to a latest Greenpeace India study, leading tea brands sold in India, both national and international, have identified the presence of pesticides that WHO has classified as both highly and moderately hazardous, and added that tea cultivation in India is on a pesticide treadmill. The NGO studied a sample of 49 branded packages of tea from eight of the 11 companies that dominate the Indian market and which also export tea. The samples were taken from Mumbai, Delhi, Kolkata and Bangalore, and sent to a certified laboratory in Europe for testing. "The pesticides result in both acute and chronic toxicity. Acute toxicity is a result of direct contact with the pesticides, and is seen in farmers and tea cultivators who experience body ache, respiratory and skin problems. Chronic impacts are seen with low doses over a long period of time. Pesticides consumed in this manner can be potentially carcinogenic, affect hormones as well as the reproductive system," said Ms Neha Saigal, senior campaigner, Greenpeace India. The study highlighted, "A large number of the samples tested positive for a cocktail of toxic pesticides. DDT was present in almost 67 percent of the tea samples, even though it is no longer registered for use in agriculture." The Tea Board of India released a statement that stated, "Indian teas are well regarded the world over and are totally safe following stringent standards." It added that the industry, led by the Board, has been taking steps to make tea cultivation more sustainable and reduce reliance on synthetic plant protection products. ]]> <![CDATA[Dr Reddy's may be prosecuted for Patent Infringement]]> https://biospectrumindia.com/news/95/4772/dr-reddys-may-be-prosecuted-for-patent-infringement.html https://biospectrumindia.com/news/95/4772/dr-reddys-may-be-prosecuted-for-patent-infringement.html Tue, 12 Aug 2014 15:54:32 +0530 Teva Pharmaceutical intends to file a law suit against Dr Reddy's Laboratories for allegedly infringing the patents of Copaxone (glatiramer acetate) injection 40mg/mL, as per the reports. Copaxone (glatiramer acetate injection) is for treatment of patients with relapsing forms of multiple sclerosis. "Teva Pharmaceutical confirms that it has received the first paragraph IV notice for its three-times-a-week Copaxone (R) 40 mg/mL product from Dr Reddy's Laboratories. Teva will continue to vigorously defend its Copaxone intellectual property rights against infringement wherever they are challenged. It intends to file a lawsuit for patent infringement against Dr Reddy's within the 45-day period provided under the Hatch-Waxman Act. The filing of the lawsuit will trigger a 30-month stay of FDA approval of Dr Reddy's ANDA," the company said in a statement. The company further mentioned that it is confident Copaxone will remain a proprietary, global market leading product for the reduction in the frequency of relapses in RRMS patients over the product's lifecycle, given the strength of its intellectual property rights. Copaxone 40mg/Ml is protected by two Orange book patents that expires in 2030. ]]> <![CDATA[Sanofi, MannKind ink exclusive licensing agreement ]]> https://biospectrumindia.com/news/95/4764/sanofi-mannkind-ink-exclusive-licensing-agreement-.html https://biospectrumindia.com/news/95/4764/sanofi-mannkind-ink-exclusive-licensing-agreement-.html Tue, 12 Aug 2014 12:41:59 +0530 Afrezza is a new, rapid-acting inhaled insulin therapy for adults with type-1 and type-2 diabetes. Under the terms of the agreement, MannKind Corporation will receive an upfront payment of $150 million and potential milestone payments of up to $775 million. The USFDA approved Afrezza Inhalation Powder on June 27, 2014, to improve glycemic control in adult patients with diabetes mellitus. The milestone payments are dependent upon specific regulatory and development targets, as well as sales thresholds. Sanofi and MannKind will share profits and losses on a global basis, with Sanofi retaining 65 percent and MannKind receiving 35 percent. Sanofi has agreed to advance to MannKind its share of the collaboration's expenses up to a limit of $175 million. The companies plan to launch Afrezza in the United States in the first quarter of 2015. "Afrezza is an innovative drug-device combination product consisting of a dry formulation of human insulin delivered through a small, discreet inhaler," said Mr Pierre Chancel, Sanofi's senior vice president, diabetes division. "Afrezza is a further addition to our growing portfolio of integrated diabetes solutions. It is uniquely positioned to provide patients with another insulin therapy option to manage their diabetes but does not require multiple daily injections." Under the collaboration and license agreement, Sanofi will be responsible for global commercial, regulatory and development activities. Under a separate supply agreement, MannKind will manufacture Afrezza at its manufacturing facility in Danbury, Connecticut, USA. In addition, the companies are planning to collaborate to expand manufacturing capacity to meet global demand as necessary. "We are so very pleased and honored that Sanofi has joined with MannKind to bring Afrezza to patients with diabetes worldwide," stated Mr Alfred Mann, MannKind's chairman and CEO. "Sanofi is the ideal partner given their complementary product portfolio, their vast insulin market presence and a leading global commercial infrastructure. Our profit-sharing agreement aligns the interests of MannKind and Sanofi to optimize development, commercialization and manufacturing costs." The closing of the transaction is subject to customary Hart-Scott-Rodino approval and completion of financing documentation. Greenhill & Co served as exclusive financial advisor to MannKind with respect to this transaction. Afrezza must be used in combination with a long-acting insulin in patients with type-1 diabetes mellitus. Afrezza is not recommended for the treatment of diabetic ketoacidosis and is not recommended for patients who smoke. ]]> <![CDATA[Passenger from Nigeria tests negative for Ebola]]> https://biospectrumindia.com/news/95/4749/passenger-from-nigeria-tests-negative-for-ebola.html https://biospectrumindia.com/news/95/4749/passenger-from-nigeria-tests-negative-for-ebola.html Tue, 12 Aug 2014 12:38:35 +0530 A traveller from Nigeria manifesting symptoms of upper respiratory tract infection at the IGI Airport on Saturday, August 9, 2014 was taken to the Ram Manohar Lohia Hospital and tested for Ebola Virus Disease (EVD). He tested negative. The two passengers who reached Chennai on August 9, 2014 ie 27-year-old male who travelled from Guinea and a 40-year-old male who travelled from Liberia are in good health and they are under observation. The high level of alertness at points of entry, coupled with the self-reporting by passengers, is leading to satisfactory results in the government's surveillance on the Ebola outbreak in West Africa. On August 8, the World Health Organization (WHO) had declared a public health emergency of international concern after an abnormal rise in the incidence of the dreaded infection this year. Within hours the Ministry unravelled its advanced surveillance and tracking system. A 24-hour helpline was also opened. Dr Harsh Vardhan, union health minister, ordered another review meeting today between officers of the Health, Home Affairs, External Affairs, Civil Aviation and National Disaster Management Authority, and representatives of World Health Organization. The meeting was chaired by the Health Secretary, Mr Lov Verma. This is the second inter-ministerial meeting in less than a week. "There is no reason for getting worried over the odd case of a visitor to the country arriving in an indisposed condition. We have all the mechanisms in place for prompt treatment and subsequent monitoring," Dr Harsh Vardhan said. The minister also directed that all technical updates on EVD, with reference to sample collection, storage and transportation, tracing and contact management, case management and notification control in hospital settings be loaded on the website of the Ministry of Health and Family Welfare. He reiterated, "There is no case of EVD in India." ]]> <![CDATA[Farmers meet environment minister, urge him to start GM crop trials]]> https://biospectrumindia.com/news/95/5723/farmers-meet-environment-minister-urge-him-to-start-gm-crop-trials.html https://biospectrumindia.com/news/95/5723/farmers-meet-environment-minister-urge-him-to-start-gm-crop-trials.html Mon, 11 Aug 2014 18:15:41 +0530 Farmer leaders from 10 states on Friday lauded union environment minister, Prakash Javadekar's bold statement that science cannot be stopped and urged him to expedite the field trials of GM crops to ensure farmers prosperity. Farmers from National Farmers Empowerment Initiative (NFEI), an umbrella organization of various farmer organizations from across the country, also submitted a signed petition to Shri Javadekar. "Allow us to take this opportunity to congratulate you for making a bold statement that "Science cannot be stopped" and clearly showcasing the need to allow scientific trials of GM crops. This has rekindled Indian farmers' hopes of receiving new technologies in our fields," the petition said. Punjab farmer leader Mr PPS Pangli, president of NFEI said, "We fear that a moratorium on research into biotechnology will ultimately have a ruinous effect on us farmers, as we will be denied crucial technology that will enable us to better our lives." "While our agricultural production has increased, our population has increased too. However, the amount of land we have to cultivate crops will not increase. The amount of water we have to nourish these crops will not increase either. Over the next decade, climate change will result in more pressure on farmers to get a good yield, with unpredictability in weather playing havoc with India's historically rain-fed agricultural system," informed NFEI vice presidents and leaders from Telangana and Maharashtra respectively, Mr S Jaipal Reddy and Mr Gunwantrao Patil. The petition added, "Till the 1960s, India's farmers were growing straight varieties of crops, using manure and other traditional means to enrich the soil. The fruits of their labour, however, fell far short of meeting the needs of the country. The introduction of high yielding hybrid seeds, advanced technology in the 60s, changed the face of Indian agriculture forever. With hybrid seeds came the combination use of modern fertilizers and irrigation techniques to optimize yields, and India's farmers have not looked back since then." "It is now time for agriculture in India to take another leap forward. And biotechnology can provide the right impetus. Technology can enable farmers to grow crops even in times of water shortage. Technology can enable crops to use nutrients available in the soil and water in a more efficient manner," added Rajasthan leader Mr Balwinder Singh Kang, joint secretary of NFEI. If there was ever a ready example of how technology directly translates into improved standards of living for farmers, it would be India's success story in cotton. Since the introduction of hybrid Bt cotton seeds in 2002 and farmers choosing to plant them widely there after, farmers have turned India into the world's second largest exporter of cotton. Anti-farmer and anti-technology activists have campaigned against the introduction of technology in agriculture at various levels, even approaching and trying to confuse the Courts. Farmers across India were taken aback by a Parliamentary Committee's Report seeking to halt Indian farmers' access to biotech-enhanced seeds, and let for example, farmers in America, Brazil, China, South Africa, Spain and 25 other countries enjoy advantages we would not. It seems like the Committee has spoken to vested interests instead of the vast multitude of farmers who have benefitted from biotechnology and who eagerly await more technology infusion in agriculture, the petition added. "While there are fears and apprehensions over genetically modified (GM) crops, the solution is to test them in our fields for safety and efficacy, and ensure firm enforcement of the existing robust regulation system. The system of checks and balances, of systematic trials and robust implementation of guidelines must be reinforced," added Mr Pangli. India needs to grow more, to ensure that every citizen can eat a safe, nutritious and affordable meal, and every farmer can prosper with the freedom to access global farmer technology and market opportunities as millions of young Indians in information technology (IT). Indian agriculture needs to grow to remain competitive in a tightening global economy, and to become an exporter of food to other parts the world, the petition added. ]]> <![CDATA[Sun Pharma banks on Daiichi Sankyo to crack Japanese market ]]> https://biospectrumindia.com/news/95/4723/sun-pharma-banks-on-daiichi-sankyo-to-crack-japanese-market-.html https://biospectrumindia.com/news/95/4723/sun-pharma-banks-on-daiichi-sankyo-to-crack-japanese-market-.html Mon, 11 Aug 2014 14:46:48 +0530 (Courtesy: The Economic Times) Sun Pharmaceutical Industries, which is in the process of acquiring control of Ranbaxy Laboratories from Daiichi Sankyo, will soon put its purchase to work through the exclusive marketing opportunity offered by two drugs in the US, rationalizing research and other costs and eventually using its association with the seller to crack the Japanese market. The $4-billion deal, announced in April, is currently awaiting various regulatory clearances. Spokespersons at Sun Pharma and Ranbaxy declined to comment. Japan, the world's largest drug market after the US and Europe, has proved tough for Indian players to succeed in. The penetration of generic drugs is less than 25 percent compared to more than 80 percent in the US drug market. But the Japanese government's intent to raise this share to 60 percent by 2017 has prompted analysts to dub it as the next big frontier for Indian drug makers. "In Japan, Indian players cannot simply succeed by replicating the strategies that have paid off in the US - of launching at the lowest price, garnering high market share and playing a volumes game," said Mr Amit Chander, partner at Baring Private Equity. "That is because Japan is an acutely brand-conscious market, where the dominant perception is that high quality and low prices do not go together," said Mr Chander, who heads the pharma and healthcare vertical at the private equity fund. In this context, Sun Pharma's strategy of partnering Daiichi, a top local drug maker, seems to be a prudent strategy, he added. Thus far, Indian drug makers have adopted two models to enter Japan. While most have begun by manufacturing raw materials for a Japanese partner in the hope of entering formulations later, some, like Lupin, have taken over local companies. "For a company of Sun's size and scale, selling just raw materials in Japan wouldn't move the needle. The Daiichi platform has the potential to offer a sure-footed entry into this tricky market," Mr Chander said. Within a year of deal closure, Sun Pharma hopes to have brought to the US market two of Ranbaxy's pending exclusive marketing opportunities - generic versions of Nexium and Valcyte. The latter earns its parents - Astra Zeneca and Roche-more than $5 billion in annual US sales. "Also within a year of closing the deal, Sun could assess R&D project overlaps between the two companies and cut costs by scrapping duplications, keeping only best projects alive," said one of the people cited earlier. This is in addition to reining in corporate expenses and general administration expenses in overlapping markets. "Ranbaxy's R&D expense has been to the tune of 9 percent of sales in the past, a low-hanging fruit for Sun Pharma to cut costs. If you look at the areas where R&D spend of India's top five drug makers go, you will not find significant difference, barring a few therapy preferences here and there," said Mr Chander. "Beyond access to the ANDAs (abbreviated new drug applications) filings of Ranbaxy, there would not be much to gain from the capabilities, different from what it already has in-house." Between the first and third year of acquisition, Sun Pharma plans to focus on realigning Ranbaxy's sales division and reap benefits flowing from integrating procurement and supply chains.During this period, it also aims to boost efficiencies in key markets, such as India and the US, to deliver $250 million of operational synergies it has promised by the third year. Sun Pharma believes that about 60 percent of synergies would accrue in the third year and aims to improve Ranbaxy's EBITDA margins to 15-16 percent by then, up from the single-digit figure at present, another person aware of Sun's plans said. Between the third and fifth year, Sun plans to use Ranbaxy's infrastructure in emerging markets -in many of which it is not present - to launch its own products. By the end of this period, Sun hopes to have sorted out Ranbaxy's prolonged regulatory troubles with the USFDA, the person aware of the company's plan said. ]]> <![CDATA[BioSpectrum Asia's 6th Annual CRO survey findings to be announced this September]]> https://biospectrumindia.com/news/95/4710/biospectrum-asias-6th-annual-cro-survey-findings-to-be-announced-this-september.html https://biospectrumindia.com/news/95/4710/biospectrum-asias-6th-annual-cro-survey-findings-to-be-announced-this-september.html Mon, 11 Aug 2014 13:26:00 +0530 Bangalore: BioSpectrum Asia will highlight a whole host of issues facing the industry, while tracking the trends of the Asia Pacific region in its annual CRO survey this September. "In an effort to assess the ecosystem trends in Contract and Clinical Research Organizations (CROs) in the Asia Pacific region, we have been conducting an annual survey of the CRO industry since 2009," explained Mr Narayanan Suresh, Group Editor - BioSpectrum (India &Asia). The survey this year will highlight the growth and challenges faced by the industry in various Asian nations. The scope of the study will include perceptions of the industry as well as its performance. The findings of the survey will be published in the September issue and will include insights shared by the CEOs of CROs across the region. The survey will prioritize the policy changes in the clinical research sector in the last one year, the major newsmakers in the Asian market, the growing interest of MNC CROs in the local market through mergers or acquisitions. It would also simplify the data generated through the survey using a geographical mapping of clinical trials in Asia for major diseases. It will also explore country specific funding and investment trends. To participate in the coveted survey, please fill in the following survey form:http://www.surveygizmo.com/s3/1755114/6th-Annual-APAC-CRO-Survey ]]> <![CDATA[Cipla, BioQuiddity announce commercial partnership]]> https://biospectrumindia.com/news/95/4712/cipla-bioquiddity-announce-commercial-partnership.html https://biospectrumindia.com/news/95/4712/cipla-bioquiddity-announce-commercial-partnership.html Mon, 11 Aug 2014 12:41:52 +0530 The agreement covers the territory of the European Union and certain other European countries. Cipla intends to launch the CE Marked OneDose ReadyfusOR pre-filled with Ropivacaine under its own label into the German market later this year. "Cipla is an excellent strategic partner for BioQuiddity and our pre-filled ready-to-use post-surgical pain product candidates," said Mr Joshua Kriesel president and CEO, BioQuiddity. "Cipla's strong commercial record puts them in an outstanding position to detail OneDose ReadyfusOR's safety, sterility, and ease of use value proposition objectives," he further expressed. The ready-to-use infusion systems are non-electric, ambulatory, and should enable seamless transition between sites of care. "We are thrilled to be BioQuiddity's European commercial partner for this product", said Mr Frank Pieters, head, Cipla Europe. "Cipla believes that this post-surgical pain product candidate presents a unique opportunity to provide an easy-to-use, well-tolerated, and efficient regional anesthesia system that could increase savings for healthcare providers and patients." ]]> <![CDATA[Cadila gets USFDA nod for its Potassium ER tablets]]> https://biospectrumindia.com/news/95/4862/cadila-gets-usfda-nod-for-its-potassium-er-tablets.html https://biospectrumindia.com/news/95/4862/cadila-gets-usfda-nod-for-its-potassium-er-tablets.html Mon, 11 Aug 2014 12:35:00 +0530 Drug firm Zydus Cadila has received final approval from the US Food and Drug administration (USFDA) to market Potassium Citrate ER tablets used in the prevention of kidney stones. "We have received final approval from the United States Food and Drug Administration (USFDA) to market Potassium Citrate ER tablets in the strengths of 5 mEq, 10 mEq and 15 mEq," company said in a statement. The estimated sales in 2014 for Potassium Citrate ER tablets is $131.7 million, as per IMS, it added. The group currently has 94 approvals and has so far filed 239 abbreviated new drug applications (ANDA). ]]> <![CDATA[NIH awards $14.5 mn to advance DNA sequencing techniques]]> https://biospectrumindia.com/news/95/4632/nih-awards-14-5-mn-to-advance-dna-sequencing-techniques.html https://biospectrumindia.com/news/95/4632/nih-awards-14-5-mn-to-advance-dna-sequencing-techniques.html Sun, 10 Aug 2014 16:43:00 +0530 Bangalore: National Institutes of Health has awarded $14.5 million to Advanced DNA Sequencing Technology program of National Human Genome Research Institute (NHGRI) to support the development of low cost DNA sequencing technology through advancements in nanopores and microfluidics technology. The new group of awards, which total more than $4.5 million in the first year, is wide-ranging, and includes several research projects directed at improving the use of nanopores in DNA sequencing or creating nanopore arrays to enable large-scale DNA sequencing efforts. One of the projects will explore the use of microfluidics in DNA library preparation. A library is a collection of stretches of physical DNA. Microfluidics can be used to capture small amounts of liquid in hair-thin channels and wells. Another team plans to test a method using an enzyme to amplify a signal that will help identify DNA bases. "While we continue to support many research projects centered on the development of nanopore technology, some of the new grants focus on additional unique approaches to sequencing DNA," said Mr Jeffery Schloss, program director, Genome Technology, NHGRI. "Despite discussion about approaching the goal of sequencing a genome for only $1,000, many challenges remain in terms of containing costs and achieving a high quality of DNA sequencing data," he added. This group of awards is the last for the Advanced DNA Sequencing Technology program, which began in 2004. "There haven't been many programs like this anywhere else over the years," Dr Schloss said. "NHGRI has had a hand in supporting some very novel research, and has helped chart exciting new directions for DNA sequencing technology." ]]> <![CDATA[Sir Jeffreys awarded the world's oldest science prize]]> https://biospectrumindia.com/news/95/4851/sir-jeffreys-awarded-the-worlds-oldest-science-prize.html https://biospectrumindia.com/news/95/4851/sir-jeffreys-awarded-the-worlds-oldest-science-prize.html Sun, 10 Aug 2014 12:19:00 +0530 The inventor of genetic fingerprinting has been awarded the world's oldest science prize, the Royal Society's Copley Medal. In 1984, Prof. Sir Alec Jeffreys stumbled upon a method of distinguishing individuals based on their DNA. It involved showing the variation between individuals' DNA, a technique which he developed, and which became known as genetic fingerprinting. This discovery transformed forensic science and resolved questions of identity and kinship. He received the medal "for his pioneering work on variation and mutation in the human genome." The Copley medal was first awarded by the Royal Society in 1731, 170 years before the first Nobel Prize. It is awarded for outstanding achievements in scientific research. Previous recipients include eminent scientists such as Charles Darwin, Michael Faraday, Albert Einstein, and Stephen Hawking. He made the discovery in his lab at the University of Leicester after looking at an X-ray image of the DNA of different members of his lab technician's family. Sir Alec Jeffreys said "I am absolutely thrilled to receive the Copley Medal. I am particularly delighted that the award recognizes our work, extending over three decades, in exploring human DNA diversity and the processes that generate this variation, and not just our accidental foray into forensic DNA." He added, "My life changed on Monday morning at 9.05 am, 10 September 1984. What emerged was the world's first genetic fingerprint. In science it is unusual to have such a eureka moment. We were getting extraordinarily variable patterns of DNA, including from our technician and her mother and father, as well as from non-human samples. My first reaction to the results was this is too complicated, and then the penny dropped and I realized we had genetic fingerprinting." He continued, "It opened up a new area of science. The research team immediately grasped its applications, including crime, paternity and identical twins, as well as work on conservation and diversity among non-human species. Later that day my wife added another to the list - immigration. That was when I realized that this had a political dimension and that it could change the face of immigration disputes, especially where no documentary evidence existed." ]]> <![CDATA[Herbal anti-malaria drug may control Asthma]]> https://biospectrumindia.com/news/95/5601/herbal-anti-malaria-drug-may-control-asthma.html https://biospectrumindia.com/news/95/5601/herbal-anti-malaria-drug-may-control-asthma.html Sun, 10 Aug 2014 11:05:00 +0530 According to researchers from the National University of Singapore (NUS), the anti-malarial herbal drug "artesunate" can herald better treatment outcomes than other asthma drugs available currently. A team has studied the therapeutic effects of artesunate against oxidative stress and oxidative lung damage which are major inflammatory events that contribute to the severity of asthma attacks. They found that artesunate could better prevent oxidative lung damage, a major molecular inflammatory event in asthmatic lungs than clinically-used corticosteroid called dexamethasone. "Artesunate can be used to better control asthma with improved outcomes and lesser adverse effects than currently available drugs," said Mr Fred Wong, associate professor, department of pharmacology, NUS. The study, published in the Journal Metabolomics suggests that patients may eventually be able to adopt artesunate as a safer and more effective alternative to control their asthma. The team led by Mr Eugene Ho Wanxing, a PhD graduate from the Saw Swee Hock School of Public Health at NUS, will further explore the therapeutic and pharmacological effects of artesunate for asthma, as well as for other medical conditions. ]]> <![CDATA[No antibiotics in poultry: IMA]]> https://biospectrumindia.com/news/95/4611/no-antibiotics-in-poultry-ima.html https://biospectrumindia.com/news/95/4611/no-antibiotics-in-poultry-ima.html Sun, 10 Aug 2014 10:39:00 +0530 The shocking revelation made by the Center for Science and Environment's (CSE) Pollution Monitoring Lab, India, highlighting rampant use of antibiotics in chicken, has plummeted chicken sales in the country. The staple Indian delicacy is no longer attracting people, mainly in the southern districts. Kerala-based chicken dealer Mr S K Naseer, who is also the state general secretary of All Kerala Poultry Federation, India, said, "During the past three days, demand for chicken has come down by 50 percent, from 6-8 lakh kg per day to 3-4 lakh kg. " Following release of CSE results, that made headlines, the Indian Medical Association (IMA) demanded an immediate ban on antibiotic use in the poultry industry. The Central Advisory Committee of the Food Safety and Standards Authority of India (FSSAI), assured that individual states will start surveillance on the issue and would review the regulatory gaps. CSE deputy general director, Mr Chandra Bhushan said that this is first step in the right direction that would help in addressing the concern. He added that the regulatory vacuum was the primary reason why the poultry industry is misusing antibiotics. Mr Bhushan further said that CSE has started writing to various central and state government functionaries highlighting the concerns and the action that needs to be taken to address this major public health issue. ]]> <![CDATA[Scrapping GM would be death knell for biotech policy: ABLE-AG]]> https://biospectrumindia.com/news/95/4573/scrapping-gm-would-be-death-knell-for-biotech-policy-able-ag.html https://biospectrumindia.com/news/95/4573/scrapping-gm-would-be-death-knell-for-biotech-policy-able-ag.html Sat, 09 Aug 2014 14:08:00 +0530 As per ABLE-AG, the biotechnology applications in agriculture should be a part of the package of solutions that address the economic and social needs of a growing population. Arguing in favor of genetically modified (GM) plants, the premier agriculture-biotech association has stated that the GM regulatory process in the country is defined by 1989 of EPA, 1986 and is one of the best in the world. It has wondered how the approval of GM crops is not acceptable while GM medicines and vaccines approved by the same GEAC are fine for the population of this country. "Every technology evolves over a period of time. Research is an essential part of the evolution of technology. We need to use new technologies as they keep evolving instead of waiting eternally. A country like India which has a high priority on increasing agricultural productivity and alleviating rural poverty cannot afford to ignore beneficial technologies" ABLE-AG believes that the issue of patenting seeds is misplaced. In the note prepared by the association, it has explained,"Indian Patent Act does not provide patents on plants and plant parts including seeds. Seeds are not patented. We have to differentiate between seeds and biotech traits. Seeds are carriers of traits, much like how computers carry a chip. The companies who develop seeds through their own research protect them under the Plant Variety Protection Act, 2002. Under this Act, the farmer has all the freedom to save the seed and reuse it. The Government has full rights to intervene if any particular seed is demanded and the company is not making it available. There are enough safeguards in the Act. The biotech traits are patentable under the Patents Act. But it will not cause any food security issues as the seeds are available, irrespective of the biotech trait. As mentioned earlier, the biotech trait is given only once to the seed company through a donor seed and it is an irreversible process. We have to note that the seed is not imported. All the Bt cotton seeds are produced in India." The long 15 point strong note by the ABLE-AG has asked few straight questions. If there should be a social debate before the introduction of every technology that affects the people then what about various other technologies which are being used by urban people?, asks the note and further seeks answers on Why only single out technologies which are helping 60 percent of our population who are dependent on agriculture? Why only single out technologies which are aimed at reducing the back breaking drudgery of our farmers? It will be a good idea for the Government to create a platform of multi-stakeholders where data-based and scientific assessment debate can take place on important technological interventions in our country. ]]> <![CDATA[Rotavirus vaccine in UIP to save medical costs, reduce mortality: PHFI study]]> https://biospectrumindia.com/reports-white-papers/95/5131/rotavirus-vaccine-in-uip-to-save-medical-costs-reduce-mortality-phfi-study.html https://biospectrumindia.com/reports-white-papers/95/5131/rotavirus-vaccine-in-uip-to-save-medical-costs-reduce-mortality-phfi-study.html Sat, 09 Aug 2014 10:37:00 +0530 A study spearheaded by the Public Health Foundation of India (PHFI) has concluded that improving immunization coverage and the introduction of a rotavirus vaccine significantly alleviates disease and financial burden in Indian households. It also points to the fact that the population subgroups or regions with low existing immunization coverage benefit the most from the intervention. Therefore, the authors of the study report of 'Analysis of Universal Immunization Program and introduction of rotavirus vaccine in India with Indianisim' have suggested that increasing coverage by targeting those subgroups alleviates the burden, more than simply increasing coverage in the population at large. As per the report, India has the highest under-five death toll globally, approximately 20 percent of which is attributed to vaccine-preventable diseases. It says that since India's Universal Immunization Program (UIP) is working both to increase immunization coverage and to introduce new vaccines, the authors analyzed how the disease and financial burden was alleviated across India's population (by wealth quintile, rural or urban area, and state) through increasing vaccination rates and introducing a rotavirus vaccine. The prominent experts, who were involved in the study and authored the study report include Mr Itamar Megiddo, Ms Abigail R Colsona, Mr Arindam Nandia, Ms Susmita Chatterjee, Mr Shankar Prinjad, Mr Ajay Khera, and Mr Ramanan Laxminarayanan. The study was conducted jointly by the Center for Disease Dynamics, Economics and Policy, Washington, DC, USA; Princeton Environmental Institute, Princeton University, Princeton, NJ, USA; Public Health Foundation of India, New Delhi; India School of Public Health, Postgraduate Institute of Medical Education and Research, Chandigarh and the Ministry of Health and Family Welfare, Government of India, New Delhi, As per Dr Ramanan Laxminarayan of PHFI, the major highlight of the study is that hospitalization could be averted and impact of rotavirus vaccine will be mainly on preventing deaths and saving medical costs. "However, the limitations remain with system challenges, cost, health improvement," he added quickly. The methodology used by the study has been carefully chosen. In the first intervention, a rotavirus vaccine is introduced at the current DPT3 immunization coverage level in India. In the second intervention, coverage of three doses of rotavirus and DPT and one dose of the measles vaccine are increased to 90 percent randomly across the population. In the third, it evaluates an increase in immunization coverage to 90 percent through targeted increases in rural and urban regions (across all states) that are below that baseline level. For each intervention, the disease is evaluated and the financial burden alleviated, costs incurred, and the cost per disability-adjusted life-year (DALY) averted. The finding of the study revealed that the baseline immunization coverage is low and has a large variance across population segments and regions. Targeting specific regions can approximately equate the rural and urban immunization rates. Introducing a rotavirus vaccine at the current DPT3 level (intervention one) averts 34.7 (95 percent uncertainty range [UR], 31.7-37.7) deaths and $215,569 (95 percent UR, $207,846-$223,292) out-of-pocket (OOP) expenditure per 100,000 under-five children. Increasing all immunization rates to 90 percent (intervention two) averts an additional 22.1 (95 percent UR, 18.6-25.7) deaths and $45,914 (95 percent UR, $37,909-$53,920) OOP expenditure. Scaling up immunization by targeting regions with low coverage (intervention three) averts a slightly higher number of deaths and expenditure. The reduced burden of rotavirus diarrhea is the primary driver of the estimated health and economic benefits in all intervention scenarios. All three interventions are cost saving, the study report has found. ]]> <![CDATA[Google's Moonshot to map a healthy human body]]> https://biospectrumindia.com/news/95/4546/googles-moonshot-to-map-a-healthy-human-body.html https://biospectrumindia.com/news/95/4546/googles-moonshot-to-map-a-healthy-human-body.html Sat, 09 Aug 2014 10:00:00 +0530 Google's Moonshot division has embarked on an ambitious health project, to develop a biochemical finger print of a healthy human body. The goal of the project is to improve the understanding of human physiology and identify any deviations from normal. The research project led by molecular biologist Dr Andrew Conrad, plans to collect genetic material from 175 people anonymously. Google X's Baseline Study will then help in identifying 'biomarkers' that enable easy and early disease detection. Dr Andrew Conrad of Google X said, "Google X Life Sciences group is working on a wearable device that Baseline participants will wear to collect data like heart rate." He added that this research would give them clues about how the human body stays healthy or becomes sick, which could in turn unlock insights into how diseases could be better detected or treated. Studying health may improve our understanding about various diseases, he said. The pilot project would further be expanded by Duke University and Stanford University to thousands of participants. The pilot study has been reviewed and approved by an Institutional Review Board (IRB), which is independent from Google. Google's involvement in the project allows researchers to employ the company's vast computational power for data processing and storage. The firm said that this research was its contribution to science and the resulting data would be made available to qualified health researchers, thus encouraging future projects at Google or at other health and technology companies. ]]> <![CDATA[WHO declares Ebola outbreak an emergency, India puts its safeguards in place ]]> https://biospectrumindia.com/news/95/4697/who-declares-ebola-outbreak-an-emergency-india-puts-its-safeguards-in-place-.html https://biospectrumindia.com/news/95/4697/who-declares-ebola-outbreak-an-emergency-india-puts-its-safeguards-in-place-.html Fri, 08 Aug 2014 17:49:00 +0530 The World Health Organization on August 08, 2014, has declared the Ebola outbreak in West Africa to be an international public health emergency that requires an extraordinary response to stop its spread. The WHO chief, Dr Margaret Chan, stated that the announcement is "a clear call for international solidarity" but also acknowledged that many countries would probably not have any Ebola cases. In India, the health ministry has ruled out any immediate threat. The number of Indians residing in the affected nations is said to be close to 45,000. The Indian government has been taking all precautions well in advance and keeping a close watch on the movement of people into India from countries affected by the virus. The health minister Dr Harsh Vardhan has stated that there is no reported case of the virus in the country and the government is taking all precautions. "As of today, this moment, there is no Ebola case reported in India. There is no need to panic," he told media persons in Delhi. The outbreak of Ebola virus in west African countries had earlier made the government ensure screening and tracking of passengers originating or transiting from there, and asked Indians to defer non-essential travel to that region. Speaking in the parliament, Dr Vardhan stated that if the situation worsens in these countries, there could be a possibility of Indians staying there travelling back to India. "Mandatory self reporting by the passengers coming from or transiting through the affected countries would be required at immigration. Also, in-flight announcements regarding thi,s would also be made by the airlines," stated the health minister. The current Ebola outbreak is said to be largest and longest outbreak ever recorded, with a death rate of about 50 percent and has so far killed at least 932 people. (With inputs from PTI report) ]]> <![CDATA[Ebola Scare: USFDA approves â€œTKM-Ebolaâ€?]]> https://biospectrumindia.com/news/95/4503/ebola-scare-usfda-approves-tkm-ebola.html https://biospectrumindia.com/news/95/4503/ebola-scare-usfda-approves-tkm-ebola.html Fri, 08 Aug 2014 17:03:00 +0530 The US FDA has modified the clinical status of the drug TKM-Ebola, manufactured by Canada-based Tekmira Pharmaceutical, the company has announced. This move will enable its potential use in humans infected with the virus. The drug was, previously, on a full clinical hold, which has now been changed to partial by the regulator. "We are pleased that the FDA has considered the risk-reward of TKM-Ebola for infected patients," said Dr Mark Murray, Tekmira's chief executive officer. He added, "We have been closely watching the Ebola virus outbreak and its consequences, and we are willing to assist with any responsible use of TKM-Ebola." The recent Ebola outbreak has killed nearly 1,000 people in West Africa. The World Health Organization (WHO) said it would convene a meeting of medical ethics experts next week to consider the implications of making experimental Ebola drugs more widely available. Tekmira's Ebola treatment is only the third, after ZMapp and Defrys, that has shown especially promising results in monkeys, but it is unproven in humans. It has only been tested in a few dozen healthy people. The FDA stopped the study of the drug in July because of safety concerns among people taking the highest doses of the drug. Some of subjects experienced immune response problems. A source within the FDA informed, "Anything that would shift the risk-benefit to a more favourable outcome could potentially allow the authorization of that study. A company would have a partial clinical hold in which the original study in healthy patients remained on hold but a new study in sick patients could proceed." ]]> <![CDATA[ABLE-AG disappointed by the halt of GM crop trials]]> https://biospectrumindia.com/news/95/5546/able-ag-disappointed-by-the-halt-of-gm-crop-trials.html https://biospectrumindia.com/news/95/5546/able-ag-disappointed-by-the-halt-of-gm-crop-trials.html Fri, 08 Aug 2014 16:22:00 +0530 We have learnt about the government's decision to halt field trials of GM crops from certain media reports. If this is indeed true, we are extremely disappointed by the anti-science, anti-domestic research recommendations which seems motivated to kill the biotechnology sector in India. Seed technologies can control pests and reduce insecticide usage, help farmers manage weeds and also manage their crops from drought, flood, heat, cold, disease or viruses. Mr Ram Kaundinya, chairman, ABLE-AG said, "While taking into account the science and scientific facts, we expect the government to make an informed decision by considering the views of the local Indian industry as well. We hope the government will not get swayed by the malicious propaganda against GM technology unleashed by certain groups with vested interests." India's agricultural productivity still ranks far below the best in the world, and if field trials are halted, it will have a far-reaching adverse impact denying new technologies to Indian farmers and the domestic seed industry, commented ABLE-AG. Moreover, India's scientific capabilities will be crippled and domestic investments and innovation by the public and the private sector in agri-biotechnology will cease. India's robust science-based regulatory environment is comparable with global standards, and must be more predictable to encourage domestic agricultural research, said the press statement. ]]> <![CDATA[Suven gets patent approval for new chemical entities]]> https://biospectrumindia.com/news/95/4502/suven-gets-patent-approval-for-new-chemical-entities.html https://biospectrumindia.com/news/95/4502/suven-gets-patent-approval-for-new-chemical-entities.html Fri, 08 Aug 2014 15:49:53 +0530 Hyderabad-based biopharmaceutical company Suven Life Sciences has announced that it has secured two patent approvals, one each from Australia and Eurasia for its new chemical entities (NCEs). They are to be used in the treatment of neurodegenerative diseases like Alzheimer's disease, Schizophrenia and Parkinson's disease. These patents are valid until 2030 and 2029 respectively, the company said in a BSE filing. The company's CEO Mr Venkat Jasti said, "We are very pleased by the grant of these patents to Suven for our pipeline of molecules in the CNS (central nervous system) arena that are being developed for cognitive disorders with high unmet medial needs, and with huge market potential globally." With these new patents, Suven has a total of 18 granted patents from Australia and 12 from Eurasia. "These patents are exclusive intellectual property of Suven products. Any of these inventions may be out-licensed at various phases of clinical development like at Phase-1 and Phase-2," the company said. ]]> <![CDATA[Lupin, LG Life Sciences to launch an anti-diabetes drug]]> https://biospectrumindia.com/news/95/4715/lupin-lg-life-sciences-to-launch-an-anti-diabetes-drug.html https://biospectrumindia.com/news/95/4715/lupin-lg-life-sciences-to-launch-an-anti-diabetes-drug.html Fri, 08 Aug 2014 13:34:00 +0530 Drug major Lupin has inked a marketing pact with South Korea's LG Life Sciences to launch its anti-diabetes drug in India. As per the strategic distribution pact inked between the two companies, Mumbai-based Lupin will launch LG Life Sciences' Insulin Glargine, a novel insulin analogue, under the brand name Basugine. "According to the agreement, Lupin would be responsible for marketing and sales of Basugine in India," Lupin said in a statement. Insulin Glargine is indicated for the treatment of adult patients with type 1 diabetes mellitus or in type 2 diabetes mellitus. Commenting on the development, Lupin Group President, India Region Formulations, Mr Shakti Chakraborty said, "I believe that our entry into the insulin analogue market with the launch of Basugine is a step in the right direction." "Lupin's foray in this segment will help the company further strengthen its diabetes portfolio, enabling it to grow deeper into the segment and fuel growth in years to come," he added. ]]> <![CDATA[Portea Medical to expand its business]]> https://biospectrumindia.com/news/95/4486/portea-medical-to-expand-its-business.html https://biospectrumindia.com/news/95/4486/portea-medical-to-expand-its-business.html Fri, 08 Aug 2014 13:30:30 +0530 Home healthcare services provider Portea Medical plans to invest $20 million (over Rs 120 crore) to expand its footprint in India across 32 new cities by the end of 2015. The Bangalore-based firm is present in 18 cities including Chennai, Delhi and NCR, Mumbai, Pune, Hyderabad, and Kolkata. "We would be investing $20 million for expansion in 32 cities by end of 2015. Our aim is to be present in 50 cities in India that have a population of more then 10 lakhs," Portea Medical co-founder and chairman Mr K Ganesh said. The company plans to raise funds for the expansion through private equity, Mr Ganesh informed. "We would be employing 5,000 more people by end of 2015, as we expand. We would also impart training to them so that patients get highest quality of medical care," he added. "We are confident about the growth of the home healthcare market. We will be looking to list the company in seven years time," he further said. The company will focus on four key areas namely geriatric care, chronic diseases, post-operative care, and in-home primary care. The company had last week raised an undisclosed amount from Qualcomm Ventures. It had earlier raised $8 million from Accel Partners and Ventureast. ]]> <![CDATA[Ebola scare: Indian airports to screen flyers]]> https://biospectrumindia.com/news/95/4444/ebola-scare-indian-airports-to-screen-flyers.html https://biospectrumindia.com/news/95/4444/ebola-scare-indian-airports-to-screen-flyers.html Fri, 08 Aug 2014 10:05:00 +0530 In line with the WHO declaration urging individual countries to bolster Ebola surveillance measures, Indian airports have been put on guard to prevent the virus from entering its borders. Chennai and Kolkata airport staff will screen flyers from African countries after authorities sounded alarm bells over the massive outbreak in Africa. Airport officials said that an Enzyme Linked Immunosorbent Assay (ELIZA) will be conducted on flyers to ensure that they are not infected by the virus. Though there are no direct flights from the worst affected countries to Chennai or other Indian cities, there are flights from there to the Gulf, from where passengers from the US, UK and Europe board connecting flights to Chennai. A large number of Nigerians also visit India. As there were no direct flights to the affected regions, India refrained from issuing a travel alert, said the Union Ministries cabinet following a risk assessment meeting recently. India's Union health minister Dr Harsh Vardhan said, "Despite low risk, the health ministry will have functioning testing and surveillance systems by next week." Dr P Ravindran, who heads emergency medical relief in the Ministry of Health said that both Delhi's National Center for Disease Control and Pune's National Institute of Virology are equipped to test for the Ebola virus. He added that though strict surveillance would be in place, considering the long incubation period of the virus, few cases may also slip in without displaying symptoms, which beats the purpose of using scanners to detect fever. ]]> <![CDATA[India, China to produce generic of Gilead's TAF]]> https://biospectrumindia.com/news/95/4474/india-china-to-produce-generic-of-gileads-taf.html https://biospectrumindia.com/news/95/4474/india-china-to-produce-generic-of-gileads-taf.html Fri, 08 Aug 2014 09:37:00 +0530 Gilead have allowed generic manufacturers in India and China to produce generic versions of its HBV and HIV drug, tenofovir alafenamide (TAF). The company is in agreement with the Medicines Patent Pool allowing generics manufacturers from both the Asian nations to produce TAF. Making the announcement at the 20th International AIDS Conference in Melbourne, Australia, Gilead said that its agreement with MPP is mainly to expand access to their investigational drug tenofovir alafenamide (TAF) for HIV and hepatitis B, contingent on the medicine's US regulatory approval. Reports added that under the agreement, the MPP can sub-license TAF to generic drug companies in India and China, who may manufacture and distribute it in 112 developing countries. "The Medicines Patent Pool plays a critical role in efforts to expand access to HIV treatment in the developing world," Mr Gregg H. Alton, executive vice president for Corporate and Medical Affairs at Gilead Sciences explained. He added, "By expanding our partnership to include TAF today, we hope to lay the groundwork for the rapid introduction of generic versions should it receive regulatory approval." The new agreement expands on Gilead's previous licensing partnership with the MPP. In July 2011, Gilead became the first pharmaceutical company to join the MPP. Today, six Indian pharmaceutical companies hold MPP sub-licenses for Gilead HIV medicines, a news report pointed out. "As the Medicines Patent Pool's first pharmaceutical industry partner, Gilead has played a vital role in increasing treatment access for people living with HIV in the developing world," said Mr Greg Perry, executive director of the MPP. "We welcome this expansion of our partnership, and we look forward to working with our sub-licensees to provide access to low-cost, high-quality versions of TAF and other Gilead antiretroviral medicines," he added. Currently 5.4 million people are receiving Gilead HIV medicines in low and middle-income countries through the company's access initiatives, more than half of all people on HIV therapy in these countries. Ninety-nine percent of these people receive versions produced by generic partners. ]]> <![CDATA[Ebola cure depends on biotech drug ZMapp]]> https://biospectrumindia.com/news/95/5717/ebola-cure-depends-on-biotech-drug-zmapp.html https://biospectrumindia.com/news/95/5717/ebola-cure-depends-on-biotech-drug-zmapp.html Thu, 07 Aug 2014 18:20:11 +0530 Strange as it may sound, the dreaded tobacco plant blamed for millions of deaths of cigarette smokers could emerge as the savior in producing the only working cure against Ebola. A small American biotech company, Mapp Pharmeceuticals, based in San Diego, California, had made available the "secret serum" the new drug ZMapp, along with another similar drug made by Canadian company Defyrus, is the only hope now to combat the deadly Ebola virus which has claimed more than 1000 lives so far in West African countries. The drug cocktail, ZMapp was administered a few days ago to two heath workers, Mr Kent Brantly and Ms Nancy Writebo, who contracted the disease while treating patients in Sierra Leone, after they were flown to the US for emergency treatment. Experts said the drug seemed to be working very well.According to a report in The New York Times, the US regulator, Food and Drugs Administration (FDA) has given special permission to use the drug, which is a cocktail of Mapp and Defyrus, as a special gesture to treat the two Ebola victims. The drug has been tested only on monkeys so far but because it showed early promise of emerging as a definitive cure, the regulator has fast-tracked the experimental use of this drug. The drug uses a new method of passive immunization to treat Ebola infection. Antibodies are extracted from infected patients and then induced into mice. The Ebola protein is then genetically altered and then inserted into tobacco leaves through a unique method developed by a German company, Icon Genetics. The antibodies are then inserted into tobacco leaves using this technology and grown in large numbers for extraction. The antibodies against the Ebola virus are then administered to patients to develop immunity to tackle the disease. Mapp is a small biotech company employing just nine scientists. Set up in 2003, the company has been quietly working in the field of biological warfare related fields for the US Defence Department. It was founded by ex-John Hopkins University faculty, Mr Larry Zeitlin and Dr Kevin J Whaley. The company has used the tobacco leaves method of production to produce large quantities of the drug more quickly than the conventional method of using mammalian cells. According to The New York Times, the US government has requested Caliber Biotherapeutics, based in Texas, to assist with the large scale production of ZMapp. ZMapp was to have been tested on healthy human volunteers in 2015. The sudden outbreak has speeded up the process and trials may be advanced now due to the global emergency. The Canadian company Defyrus too has developed a similar drug and the scientists decided to use a cocktail of the products from both Defyrus and Mapp to try it on the two infected healthcare volunteers. ]]> <![CDATA[Aurobindo aims for $2 bn revenues by FY15]]> https://biospectrumindia.com/news/95/4432/aurobindo-aims-for-2-bn-revenues-by-fy15.html https://biospectrumindia.com/news/95/4432/aurobindo-aims-for-2-bn-revenues-by-fy15.html Thu, 07 Aug 2014 17:09:00 +0530 Aurobindo Pharma eyes globalization and innovation to achieve a turnover of $2 billion in the current fiscal year. With 45 files under review with the USFDA, the firm hopes to seek approvals for nine more applications. Declaring its latest annual report, the company said that it is planning to expand businesses into European, Australian and Japanese markets to reduce the concentration of risks in other markets, mainly the US. The firm clocked a revenue of $1.4 billion in the last fiscal year. The company said in its annual report, "Leveraging on its large state-of-the-art manufacturing infrastructure for APIs and formulations, diversified basket of products and confidence of its customers, the company aims to achieve $ 2 billion revenues by 2014-15." With regard to long term growth strategy, the firm said that it planned to strengthen business in lucrative markets of Japan, Brazil, South Africa, Canada, Australia, North and West Africa and West Asia to spread risks. Aurobindo pharma said that it had achieved a remarkable milestone of 300 submissions to the USFDA by the end of 2013. ]]> <![CDATA[Modi's Japan visit: S&T ministry proposes new initiatives]]> https://biospectrumindia.com/news/95/1110/modis-japan-visit-st-ministry-proposes-new-initiatives.html https://biospectrumindia.com/news/95/1110/modis-japan-visit-st-ministry-proposes-new-initiatives.html Thu, 07 Aug 2014 16:13:10 +0530 Collaborative efforts on science and technology between India and Japan have started much ahead of prime minister, Narendra Modi's visit to the technology savvy nation. Infact, Japan has shown keen interest in Indian biotechnology research initiatives, with increasing number of joint efforts to develop solutions in various disease areas. "India will soon revive the joint Indo-Japan science and technology committee for a more effective coordination between the two important Asian nations", said Dr Jitendra Singh, union minister of state (independent charge) for science and technology and earth sciences, while welcoming the Japanese minister for science and technology Mr Hakubun Shimomura, during his visit. Dr Singh also suggested the launch of a comprehensive Fellowship Program for India and Japan Researchers in order to build national talent capacity in both the countries, to his Japanese counter-part. The minister also proposed establishing an India-Japan joint center in India in the area of "Life Sciences and Biotechnology" to look at the emerging challenges of disease biology in Asia. Mr Shimomura appreciated the suggestions and proposals made by Dr Singh and said that the cooperation between the two countries should enable India and Japan to move to a higher level of strategy engagement for providing leadership amongst Asian nations. This would also help in addressing the social needs in Health, Food, Energy and Disaster Management through the application of Science and Technology. ]]> <![CDATA[India to prepare for zero Tuberculosis deaths ]]> https://biospectrumindia.com/news/95/4423/india-to-prepare-for-zero-tuberculosis-deaths-.html https://biospectrumindia.com/news/95/4423/india-to-prepare-for-zero-tuberculosis-deaths-.html Thu, 07 Aug 2014 15:30:00 +0530 The Associated Chambers of Commerce and Industry of India (ASSOCHAM) representing health companies, has taken up the initiative of tackling tuberculosis (TB) by collaborating with NGOs, government and international funding agencies. The program of ASSOCHAM Foundation for CSR (AFCSR), in collaboration with the Central TB Division (CTD), the Directorate General of Health Services (DGHS) and the ministry of health and family welfare, government of India, calls for the support of the private sector in assisting the government's efforts to tackle India's TB burden through the Revised National TB Control Program (RNTCP). The two latest reports on the current scenario, have been developed by the United States Agency for International Development (USAID)-funded Improving Healthy Behaviors Program (IHBP), the knowledge partner of ASSOCHAM for the TB initiative. The reports were unveiled by Mr Lov Verma shortly after the inauguration of the ASSOCHAM Tuberculosis awareness, prevention and wellness program: 'Getting to Zero Death'. The first report, a monograph on 'Social and Behaviour Change Communication for Tuberculosis Control' details best practices from across the globe on how communicating healthy behaviours around TB prevention and cure has helped reduce TB-related deaths. The second report is an operational handbook on Advocacy, Communication and Social Mobilisation (ACSM), a globally recognised element of the TB control program, and how it is being used in India's RNTCP. Mr DS Rawat, secretary general, ASSOCHAM, said "In India, two deaths occur every three minutes due to TB. Given this, it is critical to bring together various stakeholders who can address the problem on one platform. They can identify how they can collaborate, and share best practices and successes. 'Getting to Zero Death' is one such platform. ASSOCHAM is privileged to collaborate with CTD and the ministry of health and family welfare on an awareness and preventive healthcare program for TB. We encourage corporates to join us in this endeavour to provide universal access to diagnosis and treatment for TB to all Indians." Speaking on the occasion, Mr John Beed, mission director, USAID India, said "Working closely with the Government of India, USAID has been supporting the Revised National TB Control Program over the last 17 years. TB remains a challenge, but the government's efforts have helped reduce the rate of infection and mortality of TB, enabling India to meet the Millennium Development Goals for TB. While there is great work being done, much work remains. So let me take this opportunity to echo Shri Lov Verma's invitation to our friends in the private sector to join the fight against TB. I hope that this effort by ASSOCHAM is the start of something big that can demonstrate to the world the abilities of the Indian private sector to support and change the course of a disease and with it, the course of history." As part of 'Getting to Zero Death,' health camps will be organised at industry sites and villages across India, covering an estimated 2,50,000 people. The program is also supported by the Ministry of Coal, Ministry of Micro, Small and Medium Enterprises, Ministry of Panchayati Raj, and Ministry of Science and Technology. ]]> <![CDATA[Biocon Foundation wins CSR award]]> https://biospectrumindia.com/news/95/4418/biocon-foundation-wins-csr-award.html https://biospectrumindia.com/news/95/4418/biocon-foundation-wins-csr-award.html Thu, 07 Aug 2014 15:09:50 +0530 Mr S Raman, VP and head, Biocon Malaysia operations, received the award on behalf of Biocon Foundation at the 4th Asia Best CSR Practices Awards held in Singapore on August 1, 2014. The Foundation has been recognized for its 'Community Cervical Cancer Screening Program'. Commenting on the award, Dr Kiran Mazumdar-Shaw, CMD, Biocon said, "This is a significant award as it endorses the challenging work that we are doing through our community cervical cancer screening program." India has the highest number of deaths from cervical cancer than any other country. Cervical cancer kills over 72,000 women in India every year, more than 26 percent of the 275,000 deaths worldwide. "Early detection of cervical cancer through Biocon Foundation's screening program has led to early treatment at lower cost and greatly enhanced treatment outcomes in the rural communities we serve," Dr Kiran added. ]]> <![CDATA[Cognizant 'buys' AstraZeneca R&D Center in Bangalore?]]> https://biospectrumindia.com/news/95/8198/cognizant-buys-astrazeneca-rd-center-in-bangalore.html https://biospectrumindia.com/news/95/8198/cognizant-buys-astrazeneca-rd-center-in-bangalore.html Thu, 07 Aug 2014 11:17:00 +0530 Cognizant Technology Solutions, India's $11 billion and No.2 software company, has reportedly purchased the iconic AstraZeneca Research Laboratory located in Hebbal, Bangalore, on the way to the airport. The 2,00,000 sq ft research laboratory is located in a 10-acre campus with the land alone valued at over Rs 400 crore ($80 million) and the high tech equipment and other research facilities are estimated to be worth another Rs 1,000 crore ($200 million).Efforts by the Government of Karnataka and the Government of India since January 2014 to salvage the facility and convert it into a BioAccelerator to help startups and educational research centers with access to some of the most sophisticated research equipment in the world have failed.It is now certain that the planned closure of the Aavishkar R&D Center, which was started 25 years ago and ushered in to some extent India's biotech revolution, will be completed in a few weeks. AstraZeneca had announced in late January 2014 that it was shutting down the center which employed over 170 scientists.Cognizant's spokesperson, Mr Harsh Kabra, declined to comment on the details of the acquisition or the company's plans to use the research center which has been in the thick of development of a vaccine against tuberculosis among other tropical diseases."As announced in January, AstraZeneca will close the Avishkar R&D site and, and as planned, is expected to exit it later this year," informed Mr Vince Docherty, a senior official at the company's global corporate affairs unit based in Hong Kong."The decision is part of our broader global business strategy to simplify our R&D footprint and focus resources on three core therapy areas (oncology, cardiovascular, and metabolic diseases, and respiratory, inflammation, and autoimmunity),'' Mr Docherty told BioSpectrum.There was intense hope that the center will be salvaged somehow. After all, when AstraZeneca shut a similar R&D center in Montreal, Canada, in 2012, the facility was taken over by the local Quebec government and converted into a biotech incubator. In fact, AstraZeneca even donated millions of dollars to run the new center.In India, no such charitable action took place. The Avishkar site seems to have been sold at the prevailing real estate rates. Representatives of Karnataka government who were in the thick of action to do a Montreal-type deal with AstraZeneca declined to comment on the failed efforts. Government of India's efforts to take over the center too has not worked. In late June, the Department of Biotechnology (DBT) secretary, Prof K VijayRaghavan, had optimistically stated that "something was being done" when asked specifically about the efforts to keep the Avishkar R&D center afloat. Scientists at C-CAMP, a DBT-funded incubator in Bangalore, had even volunteered to run the Avishakar center if taken over. AstraZeneca had reservations whether any Indian agency had the expertise to run the high-tech facility on its own. Experts indicate that the land and the facility should be converted into a real estate venture with housing and commercial complexes built there in due course. The R&D center was handling highly contagious biological material such as tuberculosis bacteria in secure containment facilities. Even if the center is shut now, it may take up to 10 years to sanitize the area for human habitation. Recently, a highly advance facility in the US had reported the escape of small pox bacteria due to mishandling and the US government had brought in stringent guidelines for handling such centers now. ]]> <![CDATA[DBT, UK join hands to launch joint partnerships]]> https://biospectrumindia.com/news/95/4412/dbt-uk-join-hands-to-launch-joint-partnerships.html https://biospectrumindia.com/news/95/4412/dbt-uk-join-hands-to-launch-joint-partnerships.html Thu, 07 Aug 2014 10:43:50 +0530 The Department of Biotechnology (DBT) and the Medical Research Council (MRC), UK have announced the launch of Joint Center Partnerships, which seek to build upon substantial pre-existing collaborations between high quality research teams based in the UK and India. This joint initiative aims to encourage and strengthen UK-India research partnerships, and to support the mobility and exchange of MRC. It will also help DBT-funded researchers to enhance established links between researchers in both the countries. One of the major areas of thrust in this joint project would be cancer biology. This includes understanding the basic biological mechanisms relevant to the etiology of cancer or mechanisms involved in cancer metastases. It also includes development of novel therapeutics, including chemical biology approaches for drug discovery. Another area of focus will be translational regenerative medicine in neuroscience which will be aimed at translating promising research into clinical trials. In this area, focus will be on regenerative medical research approaches to neuroscience or neurological disorders which have the specific aim of turning fundamental discoveries into improvements in human health. This would be by targeting pre-clinical and clinical development to human proof-of-concept studies. The other area of focus is antimicrobial resistance, especially antibody resistance as there is a rise in the number of bacteria becoming resistant to existing antibiotics without an increase in new antibiotics or new treatments. It is clear that an interdisciplinary approach is needed to tackle these challenges and make a change in addressing this growing global problem. Collaboration between the UK and India will facilitate sharing information, tools, compound libraries, datasets, and screens to acquire new insights into the emergence and spread of antibiotic resistant bacteria, the evolution of resistance and to drive the discovery of new diagnostic, preventative and therapeutic strategies for bacterial infections particularly antibiotic resistant strains. The centers will be jointly funded by the MRC and DBT. Each center should develop one node in the UK and one node in India. Although funding will be made available to expand upon and enhance current funded research activities, this call is primarily focused upon developing and enhancing research partnerships. ]]> <![CDATA[Sanofi partners with Emcure Pharma]]> https://biospectrumindia.com/news/95/4381/sanofi-partners-with-emcure-pharma.html https://biospectrumindia.com/news/95/4381/sanofi-partners-with-emcure-pharma.html Wed, 06 Aug 2014 17:22:54 +0530 Commenting on the partnership, Dr Shailesh Ayyangar, MD & VP, South Asia Sanofi India, and Sanofi-Synthelabo (India) said, "Sanofi is highly committed to the field of Oncology. Realizing that managing the complexities of cancer necessitates the availability of a wide range of products and supporting therapies, we found that combining our efforts and product range with that of Emcure Oncology makes immense sense for both companies." He further explained, "Doctors and patients will now have access 'under one roof' to one of the most comprehensive and complementing oncology portfolios in India. Sanofi will continue to provide strong scientific and medical support to Emcure's already well-established and fast growing oncology business." As per the agreement, while Sanofi will continue to own its oncology range comprising four brands namely Taxotere, Jevtana, Fludara and Fasturtec, Emcure will market and distribute these brands through its specialty unit. Mr Satish Mehta, MD, Emcure Pharmaceuticals stated, "We are delighted to be identified as the partner-of-choice by Sanofi in India, and for being entrusted with such a prestigious global oncology portfolio. We believe that the coming together of Sanofi's innovative oncology range with Emcure's oncology portfolio empowers us to provide an even wider array of value driven healthcare solutions. We are extremely optimistic about its prospects and committed to creating a long-term partnership with Sanofi." ]]> <![CDATA[Abbvies' brain tumour drug receives orphan status]]> https://biospectrumindia.com/news/95/4386/abbvies-brain-tumour-drug-receives-orphan-status.html https://biospectrumindia.com/news/95/4386/abbvies-brain-tumour-drug-receives-orphan-status.html Wed, 06 Aug 2014 17:20:28 +0530 The drug maker Abbvie, has stated that both the US Food and Drug Administration (USFDA) and European Medicines Agency (EMA) have approved ABT-414, an anti-epidermal growth factor receptor antibody drug conjugate, as a treatment for patients with glioblastoma multiforme. Every year in the US and Europe, two to three out of every 100,000 people are diagnosed with glioblastoma multiforme, the most common and most aggressive type of malignant primary brain tumour. The tumor has a five-year survival rate of just four percent and the treatment options are limited. Early clinical data for ABT-414 looks promising. In a Phase I trial presented at ASCO's annual meet earlier this year, preliminary responses were noted in three out of nine patients administered the drug. The results included two partial and one complete response. Phase II studies are currently being planned. ]]> <![CDATA[MedTech industry welcomes govt's segregation efforts ]]> https://biospectrumindia.com/news/95/4429/medtech-industry-welcomes-govts-segregation-efforts-.html https://biospectrumindia.com/news/95/4429/medtech-industry-welcomes-govts-segregation-efforts-.html Tue, 05 Aug 2014 18:38:00 +0530 In response to widespread media reports regarding medical devices, AdvaMed, an association of medical device manufacturers, recently discussed some of the regulatory hurdles the industry faces in India. It welcomed the government's efforts to create a distinction between medical devices and drugs through a separate chapter in the Drugs & Cosmetics (Amendment) Bill, and its commitment to tackling non-communicable diseases. It believes that in the long run, a separate Act would better facilitate the industry's ability to address India's healthcare challenges. Mr Sanjay Banerjee, Chair of AdvaMed India said, "For decades in India, the medical device industry has gone unrecognized as a distinct pillar of the healthcare sector. Of the 14,000 types of medical devices, only 22 are on the regulator's list and even these are treated as drugs. There is a misconception here that medical devices and drugs are the same because they are both used to treat diseases. The obfuscation of the two categories in India has limited the ability of the sector to address India's healthcare needs. There is a major gap between devices used and what is needed." There are dramatic differences between the two categories. While medical devices interact with the body in multiple ways, drugs have well-defined physiological characteristics and effects. Devices are based on mechanical/electrical/materials engineering whereas drugs are based on pharmacology, chemistry and biochemistry. As far as failure is concerned, medical device failure occurs due to mechanical/electrical component failure and biocomparability problems whereas drug-related injuries or deaths are caused by overdose, incorrect drug administration or side effects. AdvaMed is heartened that the D&C Bill 2013, which was introduced in Parliament last year, has recognized these differences and created a separate chapter for medical devices. "The medical device industry believes that in the short to medium term, the Bill has tremendous potential to remove the impediments that have limited the medical device industry from addressing India's healthcare needs in a safe, effective and timely manner. This is a great first step towards more investment, innovation and manufacture," said Ms Abby Pratt, Vice President of AdvaMed. However, the distinction between drugs and devices - for example, with respect to clinical trials - is yet to be taken to the last mile. To ensure an appropriate regulatory framework, for instance, a separate cadre of regulators trained in biomedical engineering will be needed. Pricing authorities would have to be cognizant of the variations between devices and drugs - in pharmaceuticals, pricing is a function of the product supplied while for medical devices, pricing is a function of the product and services provided. To reflect the true quality of care provided, there would have to be public reporting of quality information along with cost information. AdvaMed believes that while in the short term, the Bill can go part of the way in fixing regulatory issues, in preparing for the future, a new and separate Act (as is in place in other emerging economies like South Korea and Malaysia) would pave the way towards supporting the exponential growth of the industry and its ability to tackle India's growing non-communicable disease (NCD) burden. Medical devices play a critical role in diagnosing and managing these NCDs. For example, the evolution of coronary stents has already halved the number of patients dying from heart attacks; implantable cardiac defibrillators have increased the chances of surviving a cardiac arrest from 5 to 98 percent and diabetics now have access to accurate glucose monitoring technologies that can prevent hypoglycemia, blindness and peripheral nerve damage triggered by diabetes. "We are greatly encouraged by the Health Minister's intention to focus on non-communicable diseases. We are committed to partnering with the government in moving beyond simply removing existing regulatory problems and instead creating a healthcare system that meets the needs of Indian citizens," said Mr Banerjee. ]]> <![CDATA[Mapmygenome launches personal genomics facility ]]> https://biospectrumindia.com/news/95/4298/mapmygenome-launches-personal-genomics-facility-.html https://biospectrumindia.com/news/95/4298/mapmygenome-launches-personal-genomics-facility-.html Tue, 05 Aug 2014 18:30:31 +0530 Patients at the CARE Hospital can avail of genetic risk prediction tests at the Outpatient Centre in Banjara Hills, Hyderabad. Ms Anu Acharya, CEO of Mapmygenome, said, "We are excited about partnering with a progressive group like CARE Hospitals. CARE Hospitals Group with its reputation for transparency, ethical practice and affordability will make personal genomics more reachable to people." Mr Dilip Jose, Group CEO of CARE Hospitals, said, "The partnership with Mapmygenome is in line with our commitment to make technological advances available to our patients, besides the opportunity to work together on areas of mutual interest in research." Dr Rajeev Menon, Chief of Medical Services at CARE Hospitals commented, "Mapping the genome will help in predicting, preventing and treating a number of diseases. The collaboration will open up new possibilities and help in understanding the gene-disease interaction better." ]]> <![CDATA[US FDA recalls antibiotic drugs]]> https://biospectrumindia.com/news/95/5197/us-fda-recalls-antibiotic-drugs.html https://biospectrumindia.com/news/95/5197/us-fda-recalls-antibiotic-drugs.html Tue, 05 Aug 2014 18:28:14 +0530 The US Food and Drug Administration (FDA) has started recalling a batch of two antibiotics, Cefotaxime and Amikacin following the use of which 18 children allegedly suffered adverse reactions at a Bhiwandi hospital. The department is also investigating for any local contamination. Children between two and seven years of age complained of fever, cold, spasms and irritation after being administered a cocktail of Cefotaxime and Amikacin at the state-run Indira Gandhi Memorial Hospital (IGM). Some also started vomiting and developed breathing difficulties and needed oxygen support. The hospital said both medicines were within their expiry dates. Besides the FDA, the local health department also began an investigation of the quality of samples. "So far we have not heard of any complaints related to the batch from other places," an FDA official said. He added, "We have given orders to cease its use." The FDA also sent samples for testing. At least four children, who were suffering from pneumonia and had suffered the adverse effects, were still hospitalized. Independent experts hinted at local contamination, either of the syringe or the vials. "Amikacin is a fairly safe drug and adverse effects are a rarity," Dr Mukesh Agrawal, head of pediatrics at KEM, said. He said, "Even for Cefotaxime, one in 10,000 children may suffer from reactions. Only local contamination or improper storage conditions can explain the incident." ]]> <![CDATA[Hepatitis: Need for collective community action]]> https://biospectrumindia.com/news/95/3901/hepatitis-need-for-collective-community-action.html https://biospectrumindia.com/news/95/3901/hepatitis-need-for-collective-community-action.html Tue, 05 Aug 2014 18:05:28 +0530 The panel discussion comprised of interactive sessions on hepatitis prevalence and challenges faced by Public Health Department, strategies and community-based interventions for prevention and education of Hepatitis, and collective community impact strategies. Bristol Myers Squibb Foundation has been supporting NGOs from Mumbai such as United Way of Mumbai and AmeriCares India to create awareness on hepatitis among the slum dwellers in Mumbai. The organizations have recently concluded a week-long awareness initiative in different parts of the city such as Wadala, Chembur and Andheri. The week was marked by a series of awareness drives carried out by the Green Ribbon Brigadiers of United Way of Mumbai. The Green Ribbon Brigadiers are youth from colleges across Mumbai trained by the NGO. Dr Padmaja Keskar, executive health officer, Public Health Department, Municipal Corporation of Greater Mumbai was one of the panelists at the discussion. She said, "Together hepatitis B and C affect 500 million and kill approximately 1 million people every year. These are indicative of insufficient awareness among people about the disease. NGOs such as United Way of Mumbai and AmeriCares India are helping us spread awareness among the people with a goal of helping them take better decisions regarding their health. With more than 100,000 people dying in India due to hepatitis and also due to the 'silent' nature of the disease, it is very important for people to address the disease facts in the right manner." While speaking on the work done by United Way of Mumbai and AmeriCares India, Ms Kanchana T K, director, corporate & public affairs, philanthropy, Bristol-Myers Squibb said, "We at Bristol Myers Squibb Foundation are looking at partners who have capacity. We are looking to build sustainable models that can be looked up by other organizations. Bristol Myers Squibb Foundation has given 18 grants of approximately Rs 20 crores in the past five years. Community outreach is our main aim and we look forward to such associations." United Way of Mumbai also published an impact report on its Yuvroshni project for education, prevention and control of hepatitis during the panel discussion. Yuvroshni is a project undertaken by United Way of Mumbai for prevention, education and control of Hepatitis B and C infections in high-risk areas. Ms Jayanti Shukla, executive director, United Way of Mumbai said, "We targeted the population with high-risk groups across Mumbai to spread the message of hepatitis awareness. We have taken the help of the youth of the city to help us in our endeavor. Extensive awareness generation campaigns on occasions such as the World Hepatitis Day were carried on in slums across Mumbai. Our aim through these programs is to improve the understanding of Hepatitis B and C infections as serious infectious diseases." College youth were trained as Green Ribbon Brigadiers and health educators on hepatitis. The Green Ribbon Brigadiers helped spread awareness among the peers and community. ]]> <![CDATA[Personal genomics clinic launched in NCR]]> https://biospectrumindia.com/news/95/4310/personal-genomics-clinic-launched-in-ncr.html https://biospectrumindia.com/news/95/4310/personal-genomics-clinic-launched-in-ncr.html Tue, 05 Aug 2014 17:53:59 +0530 The clinic founded through partnership between Positive Bioscience and Medanta-The Medicity based in Gurgaon (National Capital Region), seeks to offer comprehensive personal genomics services to the customers along with advice from leading experts associated with the Medanta under one roof. The services of the clinic will include pre-empting interventions for disease prevention, pre-test genetic counselling and DNA sequencing to post-test genetic counselling. The aim is to provide comprehensive genomic services for preventive medication so as to accelerate preventive healthcare work towards disease burden reduction and improve patient care in India. Understanding the importance of personalized treatment and patient care, Positive Bioscience will offer five free cases for underprivileged cancer patients to The Times Foundation. Speaking at the launch event, Mr Pankaj Sahni,chief operating officer, Medanta - the Medicity said, "Personal Genomics has huge potential and we are honored to be the first to open a clinic in this space." He also added, "If one is not on board, they will not realize till the train leaves the station." Mr Samarth Jain, chief executive officer, Positive Bioscience explained, "The widespread appeal of personalized genomic will forever change the way we practice medicine today - from reactive to predictive. This clinic offers complete genomic services including sample collection, interpretational analysis, genetic counselling for the patients. Additionally, Medanta-The Medicity provides world class facilities and leading doctors who will provide individuals an option to consult specialists for preventive measures or screening test, thus ensuring that healthy individuals as well patients get all solutions under one roof. This is the first facility of its kind in India." Dr Howard Jacob, Director of Human and Molecular Genetics at the Medical College of Wisconsin who has come down to India for the launch said, "With genome-based testing, we can deliver comprehensive answers-accurately and quickly-to questions about genetic aberrations and rare diseases. There is a need of genome testing in India as the disease burden is significantly high. For example, if through testing, the patient learns they carry a gene for cancer, this is important for children and family members". Speaking at the event, Dr Ashok Vaid, Chairman - Medical Oncology & Haematology at Medanta-The Medicity, added, "Ever since the human Genome has been decoded, medicine has evolved. It has enabled us to be more preventive and personalized in providing care." ]]> <![CDATA[India a critical market for Eurofins Scientific]]> https://biospectrumindia.com/news/95/8196/india-a-critical-market-for-eurofins-scientific.html https://biospectrumindia.com/news/95/8196/india-a-critical-market-for-eurofins-scientific.html Tue, 05 Aug 2014 17:48:00 +0530 Bangalore: At the inauguration of Eurofins Scientifics' new Bangalore facility, Dr Matthias-Wilbur Weber, group executive vice president, Eurofins Scientific said, "India is a critical market, which is strategically important for our future growth. India will help us grow at the global level from the current 1.3 billion Euros to 2 billion Euros by 2017. "This new facility demonstrates our commitment to the Indian market, which is strategically important for our growth in the long term. Eurofins is one of the few international players in the testing business to invest in a wholly-owned facility in India. We will expand our offering to bring more and more of the Eurofins portfolio of services to customers here." Eurofins has been in India since 2009. The new facility is a mix of laboratories and office space measuring over 48,357 sq ft. Mr Sanjeev Khatri, MD, Eurofins India expressed, "The pace of growth and diversity of activities meant that all entities could not be accommodated in single rented premises. With most of our businesses starting up and quickly reaching profitability, it became quite clear that India will continue to be an attractive market for Eurofins and we shall continue to grow our presence here." Founded in 1987, the company operates five businesses overall in India, out of which four of them including genomics, food & feed testing, pharma services, and IT Solutions, are located in the new facility at Hoodi, Whitefield, in Bangalore. However, its AgroScience Services business operates from Coimbatore in Tamil Nadu. The company has leased 6 acres of land in Coimbatore where field trials of plant protection and other agrochemicals are carried out. By September 2014, Eurofins plans to have 300 employees in India. The company's clientele includes global companies in food, retail and pharma, along with reputed private and public research institutions. ]]> <![CDATA[Biocon Academy records 100% placements]]> https://biospectrumindia.com/news/95/4297/biocon-academy-records-100-placements.html https://biospectrumindia.com/news/95/4297/biocon-academy-records-100-placements.html Tue, 05 Aug 2014 13:13:58 +0530 Biocon's CMD Dr Kiran Mazumdar-Shaw, CEO & JMD Dr Arun Chandavarkar, and the newly appointed president, finance & CFO, Mr Siddharth Mittal were present during the call to answer queries from the media. "Our better mix of products and licensing revenues has enabled us to boost our profits, including the EBITDA this quarter," revealed Dr Kiran Mazumdar. Biocon is erecting its first overseas biopharma manufacturing and research facility in Johor, Malaysia. The facility is said to be the largest integrated insulin production plant in Asia, built with an investment of US$ 160 million. Dr Kiran considers Malaysia to be an attractive investment destination. "Investment in Malaysia is attractive for many reasons including tax holidays, availability of higher quality of power and water, and competitive costs, making it an ideal destination. The Malaysian government's support and approval process have been really smooth and we are very pleased with the experience," she appreciated. According to the company's website, it has already started recruiting professionals for its new Malaysian facility. "We have trained local Malaysian employees. They are ready to operate in the plant," added Dr Kiran. Answering exclusively to BioSpectrum's question on placements of the graduated first batch at Biocon Academy, Dr Kiran expressed, "The 2nd batch in the academy has already commenced in June 2014 with 30 students. They will be completing the 16-week program. As for the first batch, multiple companies had taken advantage of the students in the academy. We had 100% placements for all the students. They have been placed in companies including Novozymes, Richcore Lifesciences and of course, within Biocon as well."â€ƒ ]]> <![CDATA[Pfizer to close its Thane plant]]> https://biospectrumindia.com/news/95/4294/pfizer-to-close-its-thane-plant.html https://biospectrumindia.com/news/95/4294/pfizer-to-close-its-thane-plant.html Mon, 04 Aug 2014 18:23:00 +0530 Drug maker Pfizer has issued a lockout notice at its Thane plant following labor unrest, stating the step was necessitated to ensure safety of its employees. "Pfizer has been forced to issue a lockout notice at its Thane manufacturing plant to ensure the safety of our colleagues," the company said in a statement. There have been multiple incidents of indiscipline, threats to management personnel as well as attempts to disrupt production lines by certain workers, it added. The Thane manufacturing plant employs 212 workers. This notice for lockout will not impact the supply of any of the products or medicines to patients, Pfizer said. "The company has in place a robust business continuity plan which will ensure that its medicines are available to patients at all times," it added. In a filing to the BSE, Pfizer said, because of the incidents "it has become impossible for the management to conduct the operations of the plant in a peaceful and productive manner." "We are not in a position to resume operations until we are assured by the workers that the safety of our colleagues will not be compromised in any manner and that the workers will not indulge in acts of indiscipline at the plant," the company said. The company is headquartered in Mumbai and employees over 4,000 people across India. ]]> <![CDATA[ICMR to capitalise on indigenously developed technologies]]> https://biospectrumindia.com/news/95/3382/icmr-to-capitalise-on-indigenously-developed-technologies.html https://biospectrumindia.com/news/95/3382/icmr-to-capitalise-on-indigenously-developed-technologies.html Mon, 04 Aug 2014 17:15:49 +0530 The Indian Council of Medical Research (ICMR) will soon collaborate with private companies for further development and commercialization of a large number of indigenous healthcare technologies developed by ICMR. According to senior officials in ICMR, the collaborating private parties, including their partnering group, should have the capacity of absorbing the technology and is to be assessed for infrastructure, human resources and a clear defined plan for further development. The ICMR, through its special program aimed at the development of indigenous affordable technologies for healthcare, had developed technologies which include diagnostic assays/reagents/devices for diabetes mellitus, cervical cancer, and thalassemia; vaccines for hepatitis E; infectious diseases for tuberculosis, leptospirosis, hepatitis E, rotavirus diarrhoea, food borne pathogens, chlamydia infections, Kalazar, Malaria, Filaria and Lung Fluke infection; etc. For example, the NIV, Pune (an ICMR institute) had developed recombinant vaccine for Hepatitis E vaccine and combination of Hepatitis E and Hepatitis B vaccines using a novel approach. Some of the salient features of the technology include the liposome formulation of T1NE protein of an Indian strain of genotype 1 HEV serves as an effective candidate vaccine for hepatitis E, the liposome formulation of T1NE protein of an Indian strain of genotype 1 HEV along with the S protein of HBV serves as an effective combined candidate vaccine for hepatitis E and hepatitis B etc. Research is done at laboratory scale and a successful clinical trial on rhesus monkeys has been completed. Similarly, another ICMR institute NIOP, New Delhi has developed dot ELISA for diagnosis of a sequelae to chlamydia trachomatis infection in women using chlamydial Heat Shock Protein-60. This assay is cost-effective and is a serological test which would help in the diagnosis of women at higher risk of developing sequelae to C. trachomatis. This has a clinical relevance as it will help gynaecologists in timely therapy, thus improving the reproductive health of women. The NIV, Pune has also developed an ELISA Test for Rotavirus which is used for detection of rotavirus from the fecal samples of diarrhoea patients. It is easy to perform, has high sensitivity and specificity and is cost effective as a large number of fecal samples could be tested using indigenously developed reagents. This can essentially avoid unnecessary use of antibiotics in diarrhoea patients. The ICMR has invited expression of interest from interested companies/manufacturers/entrepreneurs for further developing these technologies. ]]> <![CDATA[Now, a blood test to detect suicide risk]]> https://biospectrumindia.com/news/95/4191/now-a-blood-test-to-detect-suicide-risk.html https://biospectrumindia.com/news/95/4191/now-a-blood-test-to-detect-suicide-risk.html Sun, 03 Aug 2014 14:17:00 +0530 Researchers at John Hopkins University have discovered a chemical alteration in a single human gene linked to stress reactions which if confirmed in larger studies, could give doctors a simple blood test to reliably predict a person's aptitude for committing suicide. According to an article in the Washington Post, researchers studied a group of chemicals that modify the brain when an individual is confronted by situations that cause stress or anxiety. A hormone, Cortisol, helps an individual cope with the stress of daily tasks as well as extreme situations. "It helps you get up in the morning, it helps you cross the road, and it helps you run away from a lion," said Mr Zachary Kaminsky, assistant professor of psychiatry and behavioral sciences at Johns Hopkins University and lead researcher of the study. A group of chemicals known as methyls can affect the gene known as SKA2, which governs the brain's response to the stress hormone. High levels of these chemicals impair the brain's ability to regulate its response to a stressful situation. As a result, anxiety and stress can build up to a point where a person becomes vulnerable to suicidal thoughts, or, bring them to the point of attempting suicide. 150 brain samples of both healthy people and those who suffered from mental illness, some of whom had been suicidal were studied initially. They found that the suicidal individuals had significantly higher levels of Methyls. Using blood tests, researchers then tested 325 living individuals for methyl levels, and used that information to see if they could predict whether certain individuals had experienced suicidal thoughts or attempted to kill themselves. Their predictions were 80 to 90 percent accurate and were based solely on the chemical effects of that single gene. ]]> <![CDATA[Public Stem Cell banking: an Initiative to save lives]]> https://biospectrumindia.com/news/95/4188/public-stem-cell-banking-an-initiative-to-save-lives.html https://biospectrumindia.com/news/95/4188/public-stem-cell-banking-an-initiative-to-save-lives.html Sun, 03 Aug 2014 12:11:00 +0530 In a bid to save millions of children by preserving their stem cells, Life cells, India's largest umblical cord banking system is setting up a public stem cell bank at the cost of Rs 30,000 crore. LifeCell's managing director, Mr Mayur Abhaya, announced the plans for the public facility at a function to mark the storage of 100,000 units of cord blood at its private banking facility. Mr Abhaya said that parents can store their child's stem cells and use them for treating various rare genetic disorders. He added, "In the US, over 70 percent of the local populace are able to find matching stem cell units for treatments. In India, however, 80 percent of the people are unable to find a match." Mr Abhaya appreciated the support of the Tamil Nadu government towards this initiative, stating that the government was the first in the country to grant Rs 9 crore to store 3,000 cord blood donations. Launching this initiative, Life cell's brand ambassador, Ms Aishwarya Rai Bacchan stressed on the necessity for parents to become aware and realize the importance of stem cell banking, highlighting that she had preserved her own daughter's cells. She mentioned, "The decision to bank umbilical cord cells had to be taken at a time when I was taking baby steps to parenthood. And on our part, we did some research, spoke to friends and our families, who advised us on the importance of stem cell banking." Ms Bachchan emphasized that stem cells were a precious gift that a parent could preserve for their child's well-being. ]]> <![CDATA[Government to set up ten hepatitis surveillance labs]]> https://biospectrumindia.com/news/95/6399/government-to-set-up-ten-hepatitis-surveillance-labs.html https://biospectrumindia.com/news/95/6399/government-to-set-up-ten-hepatitis-surveillance-labs.html Sat, 02 Aug 2014 18:31:00 +0530 The Government will set up ten regional laboratories through the National Communicable Disease Center (NCDC) for the surveillance of viral hepatitis, which kills more people than HIV/AIDS in India. "The aim of these laboratories will be to find the burden of viral hepatitis in India by 2017 and to provide lab support for investigating outbreaks," Mr Lov Verma, secretary, union health ministry said at a roundtable consultation organised by the Institute of Liver and Biliary Sciences (ILBS) in collaboration with WHO Country Office for India on the occasion of World Hepatitis Day. He also stressed on focusing on the preventive aspects rather than the treatment of viral Hepatitis given the limited health resources in India. Mass awareness, education and setting up of universal guidelines for immunization are needed to fight the disease which kills three lakh people across the country every year. "Standardization of blood bank practices and introduction of nucleic acid testing (NAT) is important for preventing blood transfusions related to viral hepatitis," Mr Verma said. There are five main hepatitis viruses, types A, B, C, D and E of which B and C are the most fatal as it can lead to liver cirrhosis and cancer. Hepatitis B and C are both blood borne and can be transmitted from man to man. "Hepatitis B is responsible for 1.4 million deaths every year (compared to 1.5 million deaths from HIV/AIDS and 1.2 million from each of malaria and TB)," said Mr Shiv Sarin, director, ILBS. "India has over 40 million hepatitis B infected patients (second only to China) and constitutes about 15 percent of the entire pool of hepatitis B in the world. Tribal areas in India have high prevalence of hepatitis B. Every year, nearly 600,000 patients die from HBV infection in the Indian continent. Outbreaks of acute and fulminant hepatitis B still occur mainly due to inadequately sterilized needles and syringes," explained Mr Sarin. He further said that increasing public awareness about the disease and its symptoms and regular health check-up for people above 40 years of age is needed to check the incidence. "ILBS is committed towards making India Hepatitis Free by 2080," he added. He also stressed on improving the access to treatment and availability as well as affordability of the drugs of Hepatitis B and C. "The government should make these drugs free of cost, or at least, heavily subsidised, like they have done in cases of tuberculosis and HIV. If you look into the economic conditions, more than half of the Indian population can not afford that," he concluded. ]]> <![CDATA[Ranbaxy partners with Cipher to market acne drug]]> https://biospectrumindia.com/news/95/4158/ranbaxy-partners-with-cipher-to-market-acne-drug.html https://biospectrumindia.com/news/95/4158/ranbaxy-partners-with-cipher-to-market-acne-drug.html Sat, 02 Aug 2014 15:09:00 +0530 Ranbaxy Laboratories announced that it had signed a licensing agreement with Cipher Pharmaceuticals to exclusively market, sell and distribute Cipher's isotretinoin capsules in Brazil. Commenting on the partnership, Mr Sanjeev I Dani, executive VP and head, global strategy, Ranbaxy, said, "We are pleased to take this novel formulation of Isotretinoin to the large market in Brazil. I am sure it would prove to be a valuable option for dermatologists and patients who suffer from severe recalcitrant nodular acne. We will utilize our strong front-end capabilities to ensure the availability of this product in Brazil." Ranbaxy plans to promote the product through a brand dermatology division in Brazil. The isotretinoin formulation is expected to be a flagship product in Ranbaxy's dermatology franchise after it achieves regulatory approval. Cipher's isotretinoin is a new formulation of isotretinoin, which is used in the treatment of severe recalcitrant nodular acne. ]]> <![CDATA[Ipca suspended exports from Ratlam plant to US]]> https://biospectrumindia.com/news/95/4083/ipca-suspended-exports-from-ratlam-plant-to-us.html https://biospectrumindia.com/news/95/4083/ipca-suspended-exports-from-ratlam-plant-to-us.html Fri, 01 Aug 2014 18:02:56 +0530 IPCA Labs has voluntarily stopped exporting the active pharmaceutical ingredients (API) manufactured at its Ratlam plant in Madhya Pradesh, to the US. This move came after the USFDA notified the company of certain regulatory issues at the manufacturing plant. "The IPCA plant had received certain observations in a Form 483 from the US Food and Drug Administration (USFDA), after an inspection", the company said. The company has decided to temporarily suspend API shipments from its Ratlam manufacturing facility to the US market till the issue is sorted out, it added. Ipca's joint MD Mr AK Jain said, "The company expects to sort out the issue in six months. The stoppage of exports would have an impact of about â‚¹150 crore." IPCA has said that its voluntary stoppage of pharmaceutical ingredient exports to the US would impact its export of finished medicine forms (formulations) to the same market. IPCA's formulations manufacturing units in Piparia (Silvassa) and SEZ, Indore (Pithampur) use the ingredients manufactured at the Ratlam plant, the company mentioned further. ]]> <![CDATA[Cadila's Gujarat plant under USFDA scanner]]> https://biospectrumindia.com/news/95/4069/cadilas-gujarat-plant-under-usfda-scanner.html https://biospectrumindia.com/news/95/4069/cadilas-gujarat-plant-under-usfda-scanner.html Fri, 01 Aug 2014 17:35:23 +0530 Drug maker Cadila Healthcare has come under the US regulatory scanner with the US Food and Drug Administration (USFDA) expressing concern over the manufacturing process of at least one product at Cadila's Moraiya facility in Gujarat. The company will respond to the observations of the FDA, made after conducting a product specific inspection of its Moraiya manufacturing plant, a company spokeswoman said. "This was a product specific review and the inspection was limited to the review of documents filed for ANDA before its approval and the observations are being responded to," a statement mentioned. There is no business impact from the FDA action and Cadila has not received any observations on the standard manufacturing practices at the Moraiya plant, the spokesperson said. The FDA communicated its concern to Cadila in a Form 483, the statement said. Once a Form 483 is issued by the FDA, the company has 15 days to respond before further action is taken. Cadila has one of the largest pipelines of 158 generic drugs awaiting approval from the FDA, according to the company filings. ]]> <![CDATA[First malaria vaccine to hit the market next year]]> https://biospectrumindia.com/news/95/7865/first-malaria-vaccine-to-hit-the-market-next-year.html https://biospectrumindia.com/news/95/7865/first-malaria-vaccine-to-hit-the-market-next-year.html Fri, 01 Aug 2014 13:13:41 +0530 The world's first malaria vaccine will be available in the market by next year, as per reports. Pharma gaint GSK has submitted a regulatory application to the European Medicines Agency (EMA) for its malaria vaccine candidate, RTS,S. It will be exclusively for use against the Plasmodium falciparum malaria parasite, which is most prevalent in sub-Saharan Africa (SSA). Around 90 percent of estimated deaths from malaria occur in SSA, and 77 percent of these are children under the age of five. Data from the phase III vaccine trial program conducted at 13 African research centers in eight African countries (Burkina Faso, Gabon, Ghana, Kenya, Malawi, Mozambique, Nigeria, and Tanzania) including over 16,000 infants and young children have also been included to support the filing. Results from a large-scale Phase III trial showed that over 18 months of follow-up, children aged 5-17 months after being given the RTS,S vaccine, experienced 46 percent fewer cases of clinical malaria, compared to children immunized with a control vaccine. An average of 941 cases of clinical malaria were prevented over 18 months of follow-up for every 1,000 children vaccinated in this age group. Severe malaria cases were reduced by 36 percent; 21 cases of severe malaria were prevented over 18 months of follow-up for every 1,000 children vaccinated. Malaria hospitalisations were reduced by 42 percent. ]]> <![CDATA[ Cipla's board appoints a new director]]> https://biospectrumindia.com/news/95/4071/-ciplas-board-appoints-a-new-director.html https://biospectrumindia.com/news/95/4071/-ciplas-board-appoints-a-new-director.html Fri, 01 Aug 2014 13:10:01 +0530 Announcing the appointment, Dr Y K Hamied, chairman, Cipla, said, "Mr Zainulbhai's 30 plus years of experience across various industries in India and the world will add a valuable perspective to our board of directors. We warmly welcome him on-board and look forward to his contribution." Mr Adil Zainulbhai retired as chairman of McKinsey India after a distinguished career, and was consulting for Indian corporations and their boards. He spent 24 years in the United States where he led McKinsey's Washington Office and founded the Minneapolis office before returning to India. On the occasion, Mr Zainulbhai said, "Cipla has had a huge impact in providing affordable pharmaceuticals to the world while building a strong company. I look forward to helping Cipla become even more successful." Mr Zainulbhai counsels the CEOs and promoters of large companies in a range of industries and has helped several such companies become global leaders. He works closely with government leaders to drive growth, raise living standards, strengthen key sectors of the economy and improve healthcare, education, and welfare. Recently, he co-edited the book, 'Reimagining India: Unlocking the potential of Asia's next superpower', a seminal publication of 65 essays from leading thinkers around the world to explore the challenges and opportunities facing the country. Mr Zainulbhai grew up in Mumbai and graduated in mechanical engineering from the Indian Institute of Technology (IIT). He also has an MBA from Harvard Business School. Also, he serves as independent director on boards of Reliance Industries, Larsen & Toubro and Network 18 and on boards of numerous non-profit organizations. ]]> <![CDATA[Study: Red wine, dark chocolate for anti-aging]]> https://biospectrumindia.com/news/95/3967/study-red-wine-dark-chocolate-for-anti-aging.html https://biospectrumindia.com/news/95/3967/study-red-wine-dark-chocolate-for-anti-aging.html Thu, 31 Jul 2014 18:29:33 +0530 Study published in the Journal of Neuroscience by a group of scientists from the Charit Universittsmedizin Berlin, indicated that a compound resveratrol, found in red wine and dark chocolate boosted cognitive functions and memory. The pilot research, conducted on overweight adults, elaborated that people who took the supplement also had more connections among brain areas involved in memory and has anti-aging affects. The study was the first of its kind to demonstrate a link between red wine and cognition. Ms Veronica Witte, a neuroscientist, Charit Universittsmedizin, said that their findings indicated that regular, high-level intake of resveratrol in the elderly may convey protective effects on cognitive functions, a hypothesis which now needs to be evaluated in large-scale clinical trials. Resveratrol is also found in red grapes, peanuts, blueberries and Japanese knotweed. Ms Witte and her colleagues tested 46 healthy participants, half of the volunteers were randomly assigned to take 200 milligrams of resveratrol daily for six months, while the other half received a placebo. The participants had undergone blood tests, memory examinations, before and after the study and the effects of the compound were clearly noticed in patients who received resveratrol. Brain scans showed more communication within the hippocampus, a memory-related brain region, and the blood tests showed reduced levels of blood sugar marker, in the people who took resveratrol. ]]> <![CDATA[Your plate of chicken may have antibiotics too]]> https://biospectrumindia.com/news/95/3966/your-plate-of-chicken-may-have-antibiotics-too.html https://biospectrumindia.com/news/95/3966/your-plate-of-chicken-may-have-antibiotics-too.html Thu, 31 Jul 2014 17:55:38 +0530 A study conducted by the Center for Science and Environment (CSE), India indicated that indiscriminate use of antibiotics in poultry farming could be strongly linked to the spread of antibiotic resistant bacteria in the community. The study, conducted on 70 chicken samples sold in Delhi, found that 40 per cent of the samples contained residues of various antibiotics in them. The research was performed in response to various alerts issued by global health experts on increased spread of antibiotic resistance in the community. The samples contained residues of 3 parts per billion and up to 31 parts per billion of antibiotics per kilogram. Ideally, "The safe limit is zero," said Mr Chandra Bhushan, deputy director general, CSE. He added, "Adding antibiotic to chicken feed of one chicken saves a poultry farm â‚¹25 per kg of chicken meat." Mr Bhushan mentioned, "It was found that large scale, unregulated use of antibiotics in poultry resulted in increased dissemination of these antibiotics among Indians. This increases the risk of Indians falling prey to otherwise curable ailments." CSE further stressed that poultry farmers were using antibiotics like ciprofloxacin, to encourage faster growth in chicken. The center emphasized that reckless use of such antibiotics can eventually make bacteria in them to become drug resistant. CSE noted that there was no regulation by the Indian government controlling the use of antibiotics in chicken, unlike the foreign countries. Mr Bhushan said that prescription of antibiotics are freely available in India and there is no law regulating its use in the poultry industry. ]]> <![CDATA[Per drop more crop: Modi mantra for agriculture]]> https://biospectrumindia.com/news/95/3573/per-drop-more-crop-modi-mantra-for-agriculture.html https://biospectrumindia.com/news/95/3573/per-drop-more-crop-modi-mantra-for-agriculture.html Thu, 31 Jul 2014 17:53:00 +0530 Addressing the agricultural scientific community at ICAR headquarters in New Delhi, the prime minister said that the work of ICAR should have two mantras: "Kam zameen, kam samay, zyaada upaj"and "per drop, more crop." To meet the challenge of "lab to land", taking scientific research to successful interventions, the Prime Minister urged agricultural colleges to start radio stations. He also called for a blue revolution that would extend the benefits of scientific research to the fisheries sector. He also called for greater research and promotion of coastal seaweed, and Himalayan herbal medicinal plants. Mr Modi asked the scientists to elaborate upon their research in simple terms so that it could be understood by the farmers, and they could be convinced to try out new products and initiatives. Earlier, Union Minister for Agriculture, Mr Radha Mohan Singh informed the Prime Minister that ICAR has prepared a contingency plan for 520 districts with the help of technical consultants. He said that ICAR has also started the program on climate base agriculture. Budget allocation for National Adaptation Fund established for Climate Change will strengthen the capacity to mitigate the adverse effects of climate change. He also said that Pradhan Mantri Agriculture Irrigation Scheme will help in increasing the size of irrigated lands and production. The Agricuture Minister also informed that 639 Krishi Vigyan Kendra (KVKs) were permitted to operate, whose major aim is to front line demonstration and to increase the reachability of KVKs. Additional KVKs were established in bigger districts. In these KVKs, technology information unit, mini seed processing unit, use of rainwater, soil and water tests, e-connectivity, corp hatchery and farm women hostel facilities etc., were given. ICAR also prepared the concept of 'Farmers First' to strengthen the Farmers- Scientists interface. Mr Singh also said that agricultural research and educational institutes are the two pillars for the development of agriculture. So it is important to confirm that Agricultural Universities were imparting quality education and prepare the agriculture graduate to counter new emerging problems in the field of agricultural research and development. The minister said that the Council is also considering programs like 'earning while learning' and other special programs for the development and to enhance capacity of rural youth. The Council has also prepared the syllabus for a starter course in Higher and intermediate classes. Mr Singh also emphasised on issues like water and its quality, soil health, protection of genetic resources, increase the farm production, management of climate change, use of resources, energy management, diversification and post crop management etc., which need to be addressed. ]]> <![CDATA[India ranks 2nd in Hepatitis B cases]]> https://biospectrumindia.com/news/95/3944/india-ranks-2nd-in-hepatitis-b-cases.html https://biospectrumindia.com/news/95/3944/india-ranks-2nd-in-hepatitis-b-cases.html Thu, 31 Jul 2014 14:55:02 +0530 India has over 40 million Hepatitis B infected patients, second only to China, and most people with chronic Hepatitis B or C are unaware of their infection, putting them at serious risk of developing cirrhosis or liver cancer which are life threatening. As India observes World Hepatitis Day tomorrow, the Institute of Liver and Biliary Sciences (ILBS) based in New Delhi has painted a grim picture on the prevalence of various forms of Hepatitis infection in the country and efforts to check it, saying the country's collective efforts in this field are "limited and painfully lagging behind". Every year, nearly 600,000 patients die from HBV infection in the region but the government does not yet have national policies relating to screening and referral for Hepatitis B or Hepatitis C, it said. Hepatitis B is a serious global health problem, responsible for 1.4 million deaths every year compared to 1.5 million deaths from HIV/AIDS and 1.2 million from each of malaria and TB, the ILBS said. "India has over 40 million hepatitis B (HBV) infected patients (second only to China) and constitutes about 15 percent of the entire pool of hepatitis B in the world."Tribal areas in India have high prevalence of hepatitis B. Every year, nearly 600,000 patients die from HBV infection in the Indian continent," the ILBL statement said. "There has been lot of talk about Hepatitis and its adverse effect and its now time for action. Our aim is to rid India of all forms of Hepatitis infections by 2080," ILBS director Mr Shiv Sarin said. On the occasion of World Hepatitis Day 2014, ILBS in partnership with the WHO India is organizing the first ever consultation meeting on 'Viral Hepatitis In Indiaâ€“Gaps, Challenges and Priorities' on July 28. This year's theme, 'Think Again' acknowledges that "we do not know nearly enough about viral hepatitis as a health threat in much of the world", it said.The study also said that Hepatitis A virus (HAV) is responsible for 10-30 percent of acute hepatitis and 5-15 percent of acute liver failure cases in India and there is a vaccine available for HA V. ]]> <![CDATA[â€œMass awareness required on simple steps to control diarrhoeaâ€? ]]> https://biospectrumindia.com/news/95/5880/mass-awareness-required-on-simple-steps-to-control-diarrhoea-.html https://biospectrumindia.com/news/95/5880/mass-awareness-required-on-simple-steps-to-control-diarrhoea-.html Wed, 30 Jul 2014 17:54:45 +0530 "Our government has placed unprecedented emphasis on out of the box solutions to long-standing problems. So much has been done for so many years. What we now need are ideas which defy the trodden path and call for courageous action," the health minister, Dr Harsh Vardhan said. The fact that India's health administrators failed to spread mass awareness on diarrhoea management speaks volumes of the inefficiency of previous programs, the minister stated. It is therefore time to think up novel communication vehicles, he added. Diarrhoea kills more than 200,000 children annually, the third biggest cause of child mortality. The minister said, "We don't have forever to bring down the death rate. By September 2015 we have to meet the United Nations Millennium Development Goals. I have therefore called for large scaling pooling of synergies to challenge the scourge of child deaths." Outlining the rationale of IDCF, the minister said it would mobilize health personnel at both central and state levels and from the volunteer sector to give momentum to diarrhoea control measures. It is essentially a set of activities which include enhancing advocacy, step up awareness generation, establish more ORS-Zinc corners, enthuse ASHA volunteers to reach Oral Rehydration Solution packets to families with children as well as detect children in need of treatment. The minister appealed to mothers not to stop breast feeding children under six months with diarrhoea symptoms. This is covered under IDCF's program for spreading knowledge of best practices on infant and child feeding. Elaborating on the program through a presentation, Dr Mathuram Santosham of John Hopkins University, Maryland, USA and Dr Rakesh Kumar, joint secretary in the Health Ministry, said that during the fortnight intensified community awareness campaigns on hygiene and age-appropriate childhood feeding practices and promotion of ORS, and Zinc Therapy will be conducted at the state, district, and village levels. Mr Louis-Georges Arsenault, UNICEF's India Representative, felicitated the Ministry for organising IDCF saying it would re-energise India's efforts to prevent child deaths in the country by increasing access to life-saving interventions. Dr Nata Menabde, World Health Organisation's chief in India, said, "Many children in the developing world cannot access urgent medical care for severe illnesses for want of hygiene, sanitation, safe drinking water and exclusive breast feeding. These should be the critical components of diarrhoea control." Mr Lov Verma, union health secretary, said that there had been a decline in infant and child mortality rates in recent years owing to increased access to immunization and child health services. ]]> <![CDATA[Strides gets USFDA approval for its transplant drug ]]> https://biospectrumindia.com/news/95/4920/strides-gets-usfda-approval-for-its-transplant-drug-.html https://biospectrumindia.com/news/95/4920/strides-gets-usfda-approval-for-its-transplant-drug-.html Wed, 30 Jul 2014 16:38:21 +0530 Strides Arcolab has announced that it has received approval from the United States Food and Drug Administration (USFDA) for the marketing of Tacrolimus capsules. The capsule is an immuno-suppressant used for preventing organ rejection following liver, kidney, or heart transplant. "We have received approval from the USFDA for Tacrolimus capsules USP, 0.5 mg, 1 mg, and 5 mg and (they) will be launched immediately," the company informed. The product will be manufactured at the company's oral dosage facility at Bangalore and marketed directly by Strides in the US market. According to IMS data as on September 2013, the US market for generic Tacrolimus is approximately $676 million. ]]> <![CDATA[Mr Bachan felicitated for his polio immunization campaign efforts]]> https://biospectrumindia.com/news/95/7804/mr-bachan-felicitated-for-his-polio-immunization-campaign-efforts.html https://biospectrumindia.com/news/95/7804/mr-bachan-felicitated-for-his-polio-immunization-campaign-efforts.html Wed, 30 Jul 2014 15:48:10 +0530 UNICEF representative for India, Mr Louis Georges Arsenault said that â€œIndia's victory over polio is a huge credit to those who mobilize people for polio vaccinationâ€?. In a bid to show the organization's gratitude for spreading awareness on the disease, Arsenault felicitated Mr Bachan, who was an active campaigner. Mr Amitabh Bachchan expressed his happiness at the disease being finally eradicated from India. "Polio eradicated from India. An eight year campaign with the UNICEF ambassadorship! Feel such accomplishment and joy!" he posted on Twitter. He also said â€œI have been doing this everyday for the past 45 years, standing in front of the camera and speaking a few sentences, and it is a very easy job for us. But the really difficult part of the job was of those who, under hard circumstances and situations, went from point to point across the nation and gave the two drops of polio vaccination to save the children from the deadly disease.â€? India was declared free of the crippling polio virus on March 27, 2014, by the World Health Organisation (WHO). It has been country's biggest public health achievement in recent times ]]> <![CDATA[Govt U turn on GM crop trials, keeps GEAC decision on hold]]> https://biospectrumindia.com/news/95/4080/govt-u-turn-on-gm-crop-trials-keeps-geac-decision-on-hold.html https://biospectrumindia.com/news/95/4080/govt-u-turn-on-gm-crop-trials-keeps-geac-decision-on-hold.html Wed, 30 Jul 2014 15:39:14 +0530 The Industry's rejoicing over Genetic Engineering Appraisal Committee (GEAC) approvals to 15 GM crops on July 18, 2014 has proved to be shortlived. In a fresh case of the government's inherited indecisiveness, the new regime has made it clear that it would be treading cautiously over the issue. In a move that points towards deferring of the field trials, it has signalled fresh consultations with all stakeholders to reach a concensus. The reason behind it is apparent pressure by the Rashtriya Svayam Sevak Sangh (RSS) affiliated Swadeshi Jagran Manch and Bhartiya Kisan Sangh who have been opposing it since a long time. As per Mr Prakash Javdekar, minister of environment and forests, "The expert panel has given recommendations but the environment minstry is yet to give a go ahead. As of now, it is just a recommendation and not a decision." While the government had earlier shown the signs of rethinking over this issue, it however, has been caught in its own words from the election manifesto that clearly opposed GM crops. Now, it would be interesting to see whether the government continues with the 'look other way' policy of the UPA or it takes a call and proves itself different. ]]> <![CDATA[GM mosquitos to fight dengue]]> https://biospectrumindia.com/news/95/4140/gm-mosquitos-to-fight-dengue.html https://biospectrumindia.com/news/95/4140/gm-mosquitos-to-fight-dengue.html Tue, 29 Jul 2014 12:18:00 +0530 UK-based Oxitec, an Oxford University spin out, has approached the Indian government for necessary approvals to begin trials for genetically-modified (GM) mosquitoes, which supposedly help in fighting the dengue menace. The modified male mosquito named '513A' will have a gene that ensures its offspring dies before reaching adulthood and thus control breeding of dengue spreading mosquitoes. This mosquito has been tested in Brazil, where dengue emerged as a big worry during the recently concluded World Cup Football tournament, and the Cayman Islands. "Oxitec is working with GBIT, a privately held Indian company that specializes in developing and commercializing novel technologies in health and agriculture, with a view to introducing this technology for dengue vector control in India," the company spokesperson said. Thousands of dengue cases are reported every year in India. In the laboratory, activity of this gene can be controlled by giving mosquitoes the antidote 'tetracycline'. With regard to regulatory clearances, GBIT has already received nod for contained laboratory-based studies. Besides, permission for larger technology trials has been sought from the Review Committee for Genetic Manipulation (RCGM). Field based studies would only begin following appraisal and approval by the relevant national bio safety committees, RCGM and Genetic Engineering Approval Committee (GEAC). "We expect a large-scale trial to be the next step; however, the timing is entirely within the hands of the RCGM," the official noted. These GM male mosquitoes can mate only with females of the same species (dengue spreading), so that it is exclusively targeted towards dengue mosquitoes with no effect on other insect species. Every wild female which mates one of the modified males will have offspring who carry the gene and without the antidote, they won't survive. "In this way, by repeatedly releasing Oxitec males, we can drastically reduce or even locally eliminate the dengue mosquito population," he said. ]]> <![CDATA[ISAAA releases 'Brief 47' on Bt brinjal, appreciated by Bangladesh agri minister]]> https://biospectrumindia.com/news/95/3942/isaaa-releases-brief-47-on-bt-brinjal-appreciated-by-bangladesh-agri-minister.html https://biospectrumindia.com/news/95/3942/isaaa-releases-brief-47-on-bt-brinjal-appreciated-by-bangladesh-agri-minister.html Mon, 28 Jul 2014 17:43:00 +0530 Brief 47 presents a thorough review and analysis of the deregulation of Bt brinjal in Bangladesh â€“ from the scientific and biosafety assessment and commercial release to the planting of Bt brinjal by farmers in Bangladesh. Bangladesh is the first country in the world to approve the commercial planting of four varieties of the insect resistant Bt brinjal on October 30, 2013. Subsequently, 20 farmers planted Bt brinjal seedlings on over 2 hectares (each on 1 bha equivalent to 0.13 ha) in four brinjal growing regions of Gazipur, Jamalpur, Pabna/Ishurdi, and Rangpur in the spring season of 2014. Notably, Bt brinjal allowed farmers to raise a healthy and vigorous brinjal crop, substantially cut down on pesticide sprays to control fruit and shoot borer (FSB) disease, considerably decreased cost of cultivation and significantly increased marketable yield. The union minister of agriculture Ms Matia Chowdhury, in her message for ISAAA Brief 47, supported the use of Bt brinjal in Bangladesh and endorsed the commercial approval of Bt brinjal as a step in the right direction. Congratulating the authors for bringing out facts on Bt brinjal to the people of Bangladesh and to the global society, Ms Chowdhury referred to the ISAAA Brief 47 as a comprehensive document that will help readers understand the rationale for the commercial release of Bt brinjal in Bangladesh. Suggesting a coherent approach on information and knowledge sharing on Bt brinjal in Bangladesh, the minister emphasized that "we accord the highest priority to the safety and benefits of the society but shun any activity that intends to spread misinformation and misguide the public about Bt brinjal or other products that are evaluated by public sector research institutions." Presenting the field level experience and evidence, Brief 47 also encapsulates the testimonials of experts and farmers attesting the benefits of Bt brinjal after a bountiful harvest in the first cropping season 2014. The Brief also presents a set of Bt brinjal photos from farmers' fields and a collection of highly cited references on Bt brinjal in Bangladesh. ]]> <![CDATA[HIV cases are declining in India: Report]]> https://biospectrumindia.com/news/95/3906/hiv-cases-are-declining-in-india-report.html https://biospectrumindia.com/news/95/3906/hiv-cases-are-declining-in-india-report.html Mon, 28 Jul 2014 17:19:00 +0530 As per a recent UN report, in India, the number of new HIV infections has declined by 19 percent between 2005 and 2013, yet the country still tops Asia in having 38 percent of all new HIV infections on the continent. India also recorded a 38 percent decline in AIDS-related deaths during this period. India has 2.1 million people living with HIV, accounting for 40 percent of those infected in Asia. The country also accounted for 51 percent of AIDS-related deaths in Asia in 2013, and eight percent of deaths worldwide. The report also mentioned that after sub-Saharan Africa, the largest number of people living with HIV are in Asia and the Pacific. There were an estimated 4.8 million people living with HIV in this region in 2013. China, India, Indonesia, Myanmar, Thailand and Vietnam account for more than 90 percent of the people living with HIV in the region. The United Nations program on HIV/ AIDS, which published the latest numbers said that around 19 million out of the 35 million people infected with HIV across the world are unaware of their HIV positive status. The Indian government said the UN report shows the steady progress India has been making. "The Department of AIDS Control has been working closely with the Department of Health and Family Welfare toward integration of HIV and AIDS services into the larger health system," a senior Health ministry official said. ]]> <![CDATA[A new partnership to revive global agricultural education]]> https://biospectrumindia.com/news/95/3887/a-new-partnership-to-revive-global-agricultural-education.html https://biospectrumindia.com/news/95/3887/a-new-partnership-to-revive-global-agricultural-education.html Sat, 26 Jul 2014 16:11:00 +0530 An international partnership consisting of top Universities and the collaboration of the International Crops Research Institute for the Semi-Arid Tropics (ICRISAT) across India, Africa and the USA has formed the 'One Agriculture-One Science: A Global Education Consortium' initiative. 'One Agriculture-One Science' is a consortium of agricultural education institutes, research organizations and other related agencies specifically focused on addressing changes and adaptations required for agricultural education to be better and make an impact on development goals. Particularly the attainment of food and nutritional security, and sustainable agricultural production in developing countries. The workshop jointly organized by ICRISAT, the University of Florida (UF), Michigan State University and Iowa State University, held at UF, Gainesville, Florida, USA on 17-18 July 2014 was attended by select experts from land grant state universities in the USA, the Indian Council of Agricultural Research (ICAR), the African Green Revolution Alliance (AGRA), the Regional University Forum for Capacity Building in Agriculture (RUFORUM, a consortium of 42 universities in 19 countries in Africa), US Department of Agriculture, US Agency for International Development, and CGIAR centers. 'One Agriculture-One Science' is a common platform to comprehensively address gaps in agricultural education with latest advancements in technology and knowledge flow strategies," said Dr William D Dar, director general, ICRISAT, at the launch of the initiative. "The task of revitalizing global agricultural education requires all of us to work together in developing an educational and capacity building road map focused on how we can better contribute to global food and nutritional security through a global education consortium for development," he continued. "As a land grant university engaged in worldwide research, we at UF's Institute of Food and Agricultural Sciences (IFAS) know that relationships with our international partners are reciprocal, and that sometimes, we experience reverse technology transfer," said Dr Jack Payne, senior VP, UF, Gainesville. ]]> <![CDATA[Glenmark's consolidated revenue increases by 20.08% for Q1]]> https://biospectrumindia.com/news/95/4015/glenmarks-consolidated-revenue-increases-by-20-08-for-q1.html https://biospectrumindia.com/news/95/4015/glenmarks-consolidated-revenue-increases-by-20-08-for-q1.html Mon, 28 Jul 2014 15:23:05 +0530 Its consolidated revenue was at Rs 14,869.40 Mn ($248.61 Mn) as against Rs 12,382.43 Mn ($221.91 Mn) in the corresponding quarter, recording a growth of 20.08 percent. Consolidated EBITDA grew by 38.16 percent to Rs 3423.32 Mn from Rs 2477.82 Mn in the quarter. The consolidated Net Profit was at Rs 1848.46 Mn for the quarterended June 30, 2014 as compared to Rs 1286.76 Mn for the previous corresponding quarter registering an increase of 43.65 percent. "We have delivered strong results backed by good performances by our India, rest of the world, Europe and LATAM businesses. While we outperformed in the Indian pharmaceutical market with a growth of over 20 percent, our rest of the world business led by Russia and LATAM operations bounced back strongly in this quarter with growth rates of over 20 percent and 30 percent respectively," said Mr Glenn Saldanha, CMD, Glenmark Pharmaceuticals. "We have been making steady progress in our innovation pipeline and now have three first-in-class monoclonal antibodies (mAb) in clinical development. It is encouraging to note that very few companies around the world have three first-in-class mAbs in clinical development. The inauguration of a new monoclonal antibody manufacturing facility in Switzerland was an important development during this quarter, which now gives us end-to-end capabilities for the discovery and development of novel monoclonal antibodies," he further added. India Formulations Sales for the formulation business in India for the first quarter ended June 30, 2014, was at Rs 3,971.59 Mn ($66.40 Mn) as against Rs 3,285.83 Mn ($58.89 Mn) in the previous corresponding quarter, recording a growth of 20.87 percent. USA Formulations Glenmark Generics, USA, registered revenue from the sale of finished dosage formulations wasat Rs 4,886.70 Mn ($81.70 Mn) for the quarter ended June 30, 2014 as against revenue of Rs 4,469.52 Mn ($80.10 Mn) for the previous corresponding quarter, recording an increase of 9.33 percent. Africa, Asia and CIS Region (ROW) For the first quarter, revenue from Africa, Asia and CIS region was Rs 2,113.09 Mn ($35.33 Mn) as against Rs 1,751.20 Mn ($31.38 Mn) for the previous corresponding quarter, recording an increase of 20.67 percent. Europe Formulations Glenmark Europe's operations revenue for the first quarter ended June 30, 2014 was at Rs 977.26 Mn ($16.34 Mn) as against Rs 726.45 Mn ($13.02 Mn) recording growth of 34.53 percent. Latin America Glenmark's revenue from its Latin American and Caribbean operations was at Rs 1,176.45 Mn ($19.67 Mn) for the first quarter ended June 30, 2014 as against Rs 878.49 Mn ($15.74 Mn) an increase of 33.92 percent. Active Pharmaceutical Ingredients (API) Revenue from sale of API to regulated and semi-regulated markets globally was Rs 1,445.26 Mn ($24.16 Mn), for the quarter ended June 30, 2014 against Rs 1,270.94 Mn ($22.78 Mn) for the previous corresponding quarter, recording an increase of 13.72 percent. ]]> <![CDATA[Top 20: Investing huge in oral insulin R&D]]> https://biospectrumindia.com/features/95/4058/top-20-investing-huge-in-oral-insulin-rd.html https://biospectrumindia.com/features/95/4058/top-20-investing-huge-in-oral-insulin-rd.html Mon, 28 Jul 2014 15:23:00 +0530 Industry experts believe that Novo Nordisk's Insulin Degludec/Liraglutide is set to become the clinical gold standard among fixed-dose combination therapies for Type-2 diabetes.Novo Nordisk experienced a major setback in 2013 when the FDA rejected its insulin Tresiba. However, Novo is optimistic to bet upwards of $3.7 billion in the process of developing new oral diabetes therapies.The company is committed in elevating its R&D project involving about 500 professionals and scientists, planning for gennext efforts for oral insulin and oral GLP-1 drug, which is a new stage where other major players in the industry like Elii Lilly, Sanofi and GlaxoSmithKline are also involved.However, there's been intense competition to develop oral SGLT2 drugs, and Novo's experts believe that the rivalry can become much more intense in the next couple of years.Also, Novo Nordisk has chalked out plans to build a new purification plant at its R&D facility in Bagsvaerd, Denmark, to support its diabetes pipeline.The company has been investing 1 billion Kronar a year in its R&D for several oral insulin and GLP-1 products making therapies available for patients who prefer oral drugs to avoid injections.Up to 2022, Novo Nordisk expects to hire 6,000 new employees in Denmark, half of whom will work within R&D. ]]> <![CDATA[Govt working towards eradication of Measles by 2020 ]]> https://biospectrumindia.com/news/95/4926/govt-working-towards-eradication-of-measles-by-2020-.html https://biospectrumindia.com/news/95/4926/govt-working-towards-eradication-of-measles-by-2020-.html Mon, 28 Jul 2014 15:14:44 +0530 The government is working towards eliminating measles by 2020 along with other South East Asian Regional countries of the World Health Organization. As per ministry of health, the two doses of measles vaccine have been introduced in the Universal Immunization Program (UIP) in the year 2010-11. In 14 states or Union Territories where the evaluated coverage for measles was less than 80 percent, introduction of two doses of measles vaccine under UIP was preceded by a mass measles vaccination campaign covering children in the age group of 9 months to 10 years. 118 lakh children were vaccinated during these campaigns. Laboratory supported measles surveillance has started in the country which is based on the polio surveillance model. ]]> <![CDATA[IPA terms assessment of Indian IP policy by USTR, unfair]]> https://biospectrumindia.com/news/95/5881/ipa-terms-assessment-of-indian-ip-policy-by-ustr-unfair.html https://biospectrumindia.com/news/95/5881/ipa-terms-assessment-of-indian-ip-policy-by-ustr-unfair.html Mon, 28 Jul 2014 15:12:22 +0530 IPA has challenged the USTR's assessment of India's intellectual property protection regime and suggested that India received severe treatment than other countries solely on the basis of its treatment of patented pharmaceuticals, which it says meet international obligations. The secretary general of the IPA, Mr D G Shah, remarked that the USTR had removed the Philippines from its 2014 Special 301 watch list, but maintained India on its priority watch list. According to the USTR's watch list a priority list have been created under its trade legislation to answer to its obligation to identify countries which it deems do not provide adequate and effective protection for US intellectual property rights. The Special 301 report displaying those lists was first published in 1989. Countries placed on the priority watch list "become the focus of increased bilateral attention concerning the problem areas," the USTR website said. USTR, in April, had announced that it has removed the Philippines from the Special 301 watch list. The country was listed continuously since 1994, and was first listed in 1989, the release said. The removal from the watch list resulted from a series of "significant legislative and regulatory reforms by the Philipines to enhance the protection and enforcement of intellectual property rights in the country," said the release. According to the 2014 Special 301 report, "In 2014, 10 countries are on the Priority Watch List and 27 countries are on the Watch List." Of those, "several countries, including Chile, China, India, Indonesia, Thailand, and Turkey, have been listed every year since the Report's inception." Mr Shah's paper notes that the Pharmaceutical Research and Manufacturers of America (PhRMA), in its submission [pdf] to the USTR on Special 301, formulated complaints about India and the Philippines that were very similar. In particular, they pointed out narrow standards of patentability, lack of regulatory data protection, and issues with patent enforcement and drug regulatory approval. The only difference, according to Mr Shah, is the use of compulsory licensing by India, while the Philippines, due to its lack of manufacturing capabilities, has been using parallel importations. Compulsory licences for pharmaceutical products are used in certain cases by governments that allow the production of a patented product without the consent of the patent owner, according to the World Trade Organization. Compulsory licences are one of the flexibilities for patent protection permitted under the WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). The WTO defines parallel importations to designate products that are manufactured abroad and imported without the permission of the IP right holder. PhRMA classified the Philippines under "watch list" and India under "priority foreign country," along with Turkey. According to the USTR, countries designated as priority foreign countries are "potentially subject to an investigation under the Section 301 provisions of the Trade Act of 1974." According to Mr Shah, the USTR report on India is "full of inaccuracies," and "India's disagreement on some IP issues with the US is reduced to 'difficulties in attaining constructive engagement' and 'challenging environment'." The USTR "has completely ignored several steps taken by India to bring transparency and accountability in the IP administration; to improve efficiency and speed through recruitment and training; and modernization of IP offices," the paper said. Mr Shah's paper lists the steps allegedly taken by India to improve its IP policy framework, in particular: the digitisation of all IP records; the electronic processing of patents and trademark applications; public search facility, manuals of office practice and procedures for patents, designs and geographical indications; specialised technology groups for examination of patent applications; and exposure to international best practices. Section 3(d) of India's Patent Act 1970 has been a recurring concern for the USTR and is mentioned in the 2014 USTR Special 301 report. Section 3(d) states that "the mere discovery of a new form of a known substance which does not result in the enhancement of the known efficacy of that substance or the mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs at least one new reactant." It is presented by India as preventing the "evergreening" of patents, preserving national policy space while satisfying its international trade obligations, and regarded by pharmaceutical companies as limiting the patentability of innovations. ]]> <![CDATA[Bristol-Meyers appoints a new India country head]]> https://biospectrumindia.com/news/95/3910/bristol-meyers-appoints-a-new-india-country-head.html https://biospectrumindia.com/news/95/3910/bristol-meyers-appoints-a-new-india-country-head.html Mon, 28 Jul 2014 15:08:16 +0530 US drugmaker Bristol-Myers Squibb(BMS) announced that Mr Jitendra Tyagi has been appointed as BMS India country head effective July 22, 2014. He will report to Mr Michael Norman, general manager - Middle East, Africa and India. Commenting on the appointment, Mr Norman said, "Mr Jitendra Tyagi has successfully performed diverse commercial roles at BMS India in the past few years. He is known for his ability to think strategically, resolve complex business challenges, connect and collaborate." Mr Jitendra Tyagi brings a broad range of experience to his role. He joined BMS in 2010 as director-MRCEI. In the last few years, he has performed diverse commercial roles in India such as Business Unit Head, and in Market Research, Market Access, Key Accounts, Business Excellence and Patient Support Program. He was the Project Leader who ensured a smooth transition of the diabetes business as well as of the employees to AstraZeneca India. In his most recent role in BMS, he led the Critical Care and Cardiovascular Business Unit, where he also efficiently managed the alliance with Pfizer. Prior to joining BMS India, Mr Jitendra spent more than 21 years at Novartis India in a number of leadership positions. ]]> <![CDATA[Top 20: Clinical trials' uncertainty an insurmountable task]]> https://biospectrumindia.com/features/95/4003/top-20-clinical-trials-uncertainty-an-insurmountable-task.html https://biospectrumindia.com/features/95/4003/top-20-clinical-trials-uncertainty-an-insurmountable-task.html Fri, 25 Jul 2014 14:43:00 +0530 Biocon outperformed the 6 percent growth of the Indian pharmaceutical industry with a 12 percent growth in biopharmaceutical revenues. In August 2013, Biocon launched ALZUMAb, a novel "first-in-class" biologic drug, for chronic plaque psoriasis in India. ALZUMAb is the second novel biologic launched by Biocon and represents the first biological drug for psoriasis to be researched, developed, and manufactured in India. Biocon also launched its CANMAb in January 2014. This is believed to be the world's lowest priced trastuzumab for the treatment of HER2-positive metastatic breast cancer in India. The company witnessed many collaborative partnerships during the fiscal year. It entered into a licensing and collaborative partnership with Quark Pharmaceuticals to co-develop, manufacture and commercialize QPI-1007, a novel siRNA drug candidate for ophthalmic conditions, in India and other key markets. It also signed a pact with US-based Advaxis for the co-development and commercialization of ADXS-HPV, a novel cancer immunotherapy for the treatment of human papillomavirus (HPV), associated with cervical cancer in women. Biocon's strategic tie-up with CytoSorbents for the sale of CytoSorb, for sepsis management, in India and other selected Asian markets was also a major milestone for the company.Uncertainty over clinical trials continued to pose a serious challenge in FY13-14. The hostile clinical trials environment in India has forced Biocon to take some clinical development programs overseas, which in turn is expected to push up its R&D spend.Biocon was also listed 6th among 10 leading biopharma employers in the world, according to a survey conducted by the prestigious Science magazine in 2013.Another feather in the cap for Biocon was establishing the Biocon Academy as a Centre of Excellence for advanced learning in biosciences. In partnership with the Keck Graduate Institute of Claremont (California, USA), Biocon Academy flagged-off the first Biocon KGI program in Biosciences. ]]> <![CDATA[Top 20: Serum retains No 1 crown]]> https://biospectrumindia.com/features/95/6494/top-20-serum-retains-no-1-crown.html https://biospectrumindia.com/features/95/6494/top-20-serum-retains-no-1-crown.html Fri, 25 Jul 2014 13:07:00 +0530 Dr Cyrus Poonawalla, founder and chairman of vaccines major, Serum Institute of India (SII), has been a busy man in the last few years. He has been the brain behind strategic moves which saw his company march much ahead of its nearest competitors in India. The company has witnessed a huge 71 percent growth rate, recording Rs 3340 as revenue in FY 2013-14 as compared to Rs 2374 crore in FY 2012-13. The fiscal year just gone by saw Serum becoming a part of new partnerships and acquisitions. With fresh vigor, the company is all set to take on global pharma giants with renewed strategies in 2014-15. The world's 5th largest vaccine manufacturer (by volume) with an installed capacity of over one billion doses of different vaccines, Serum has taken up a major challenge this year to develop a vaccine for dengue. In this regard, Serum has tied up with the University of Mahidol, Thailand. For the first time, the company has joined hands with Bilthoven Biologicals, Netherlands in an endeavor to support the goal of reaching the Global Polio Eradication Initiative (GPEI) Endgame Strategic Plan 2013-2018. This has resulted in triggering a global reduction in price of IPV from the prevailing price available in the market, in a tender bid with UNICEF. Dr Poonawalla had stated that he was proud to support the IPV program in keeping with his commitment to the World Health Organization, to make available Polio vaccine as affordable as possible. With the R&D efforts that are being put in, he is confident that the price of IPV will further reduce in the future. Another important activity of Serum was the signing of a contract with Hannover-based Vaccine Project Management, GmbH to acquire rights to the new tuberculosis vaccine. The new vaccine called VPM1002 consists of attenuated pathogens and prompts the human immune system to mount a response against the germ. The special feature of VPM1002 is that it is being continually refined using gene technology, causing it to prevent diseases much more effectively and safely than its predecessor. Recently, the global player has also inked a deal with Sydney-based biotechnology firm, NeuClone, where a major licensing agreement and a joint development partnership have been signed. This will cover the manufacturing of 10 biosimilar drugs. As per the agreement, NeuClone will use its NeuMAX cell line development platform to manufacture and supply 10 biosimilar monoclonal antibody drugs, while Serum will provide its biologics manufacturing capability. Serum offers curative as well as preventive medicines in niche segments such as measles, MMR, rubella, rabies, hepatitis B, haemophilus influenza type B (HiB) and DTP, among others. The company has set up Serum Bio Pharma Park, a sector-specific SEZ meant for biotechnology and pharmaceutical products. ]]> <![CDATA[Biocon's biopharma biz records Rs 436 cr for Q1 FY15]]> https://biospectrumindia.com/news/95/3677/biocons-biopharma-biz-records-rs-436-cr-for-q1-fy15.html https://biospectrumindia.com/news/95/3677/biocons-biopharma-biz-records-rs-436-cr-for-q1-fy15.html Fri, 25 Jul 2014 12:06:24 +0530 According to Biocon, the biopharma business was impacted this quarter by various external factors including the ongoing geo-political conflicts in the MENA region, affecting the growth of the business. Commenting on the occasion, Dr Kiran Mazumdar-Shaw, CMD, Biocon, stated, "Our revenue growth this quarter has been muted. Our business performance reflects the challenges that we are temporarily facing in some of our key markets especially in the Middle East. We are working towards diversifying our regional dependencies to diminish the impact of such externalities. However, we have sustained our operating margins and profits despite increase in costs." "Our business profitability has remained intact indicating the benefits of portfolio optimization. Our development pipeline across biosimilars and novel candidates continues to progress well. We remain committed towards improving our performance in the coming quarters," she continued. The company also, this quarter, filed its first ANDAs, targeting the US generics market. "This effort is part of our communicated strategy to move up the pharma value chain to enter finished dosages with generic formulations. We continue working towards further optimization of our product portfolio in the small molecules vertical, with a clear focus on profitable growth," said Biocon's press statement. Biocon is on track to initiate global phase III trials for its biosimilar glargine. Its upcoming insulin facility in Malaysia continues to progress and the plant is expected to be commissioned in the second half of this fiscal. The company's branded formulations recorded revenues of Rs 111 crore in Q1 FY15. The vertical grew at 10% YoY, in line with the industry. This quarter, Biocon has reorganized certain divisions within this vertical. The reorganization largely focuses around the cardiology and diabetes divisions to drive synergies around key anchor brands and optimization of product portfolios with a focus on profitability. The initial set of trials for oral insulin molecule, IN-105 is on track, according to Biocon. "We continue to engage with potential partners to out-licensing discussions for our novel anti-CD6 molecule, Itolizumab," quoted Biocon. Also, the research services segment grew by 12% YoY in Q1 FY15, recording revenues of Rs 172 crore. Commenting on the performance, Mr Peter Bains, director, Syngene International, said, "We have made a steady start to the new fiscal, and will build upon this performance during the course of the year. We have been investing in capacity expansions, some of which will come into play in the latter half of FY15. The new capacities will help us expand our order book and build growth momentum. A key milestone this quarter was the extension of our partnership with Bristol-Myers Squibb until the year 2020." ]]> <![CDATA[Biocon appoints new CFO]]> https://biospectrumindia.com/news/95/3675/biocon-appoints-new-cfo.html https://biospectrumindia.com/news/95/3675/biocon-appoints-new-cfo.html Fri, 25 Jul 2014 11:56:48 +0530 Mr Mittal joined Biocon in May 2013 and takes over from Mr Murali Krishnan, who retires after more than 30 years of service with the organization. The new CFO is a chartered accountant (India) and a CPA (US) and carries more than 15 years of global and diversified experience. Prior to joining Biocon, Mr Mittal was the vice president-finance, and corporate controller with a leading US-based IT MNC in Bangalore. ]]> <![CDATA[Telangana Government to set up a new Pharma city ]]> https://biospectrumindia.com/news/95/3848/telangana-government-to-set-up-a-new-pharma-city-.html https://biospectrumindia.com/news/95/3848/telangana-government-to-set-up-a-new-pharma-city-.html Fri, 25 Jul 2014 10:27:25 +0530 Telangana Government is planning to set up a 'Pharma City' near Hyderabad. The city is expexted to be spread over 8,000 acres and will include industries as well as a residential colony, and a power plant with 500 MW capacity to provide captive, dedicated and uninterrupted power supply to the industry, as per reports. The required land, infrastructure facilities, communication facility, power supply, water supply etc. will be provided by the government. "The pharma city is expected to accommodate about five lakh employees with families in the residential colony. The number is expected to touch 20 lakhs over a period of time," said chief minister Mr K Chandrasekhar Rao in a press release. The chief minister has suggested to a delegation of Drugs Manufacturers' Association that an international consultancy organization with expertise in developing industrial estates should be contacted to design the pharma city. The association, in turn, requested the chief minister to create an exclusive department for pharma, to which he responded positively, the press release further said. ]]> <![CDATA[Bengal affected by Japanese Encephalitis, Centre offers help]]> https://biospectrumindia.com/news/95/5188/bengal-affected-by-japanese-encephalitis-centre-offers-help.html https://biospectrumindia.com/news/95/5188/bengal-affected-by-japanese-encephalitis-centre-offers-help.html Thu, 24 Jul 2014 16:26:41 +0530 The union health minister, Dr Harsh Vardhan has written to Ms Mamata Banerjee, chief minister of West Bengal regarding neo-natal deaths in the state due to AES and JE and offered help of the central government. In his letter, the health minister has stated that the flow of reports from West Bengal on neonatal deaths and fatalities from AES and JE had prompted him to send specialist teams to the affected areas during the current month. The Minister states that there are infrastructure issues that need to be addressed as we are only a year away from the deadline for meeting the Millennium Development Goals on MCH parameters. Regarding the deaths due to JE-AES in north Bengal, the health minister states that the ministry has stepped up the immunization drive against JE and cleared the installation of urgently needed hospital infrastructure in affected areas. He notes that he has himself flagged off a mass immunization drive in June in Bihar. Dr Harsh Vardhan has assured the chief minister of West Bengal of his personal interest in extending all facilities to help her tide over the crisis. He has also recommended, for a start, intensive and extensive consultations between the state and central officials on the steps to be taken on an emergency basis, and also on the permanent measures that would be necessary to avoid such tragedies in the future. ]]> <![CDATA[Strides Arcolab buys majority stake in Bafna Pharma]]> https://biospectrumindia.com/news/95/6591/strides-arcolab-buys-majority-stake-in-bafna-pharma.html https://biospectrumindia.com/news/95/6591/strides-arcolab-buys-majority-stake-in-bafna-pharma.html Thu, 24 Jul 2014 15:29:17 +0530 Bangalore-based Strides Arcolab, announced that it has entered into an agreement with Chennai-based Bafna Pharmaceuticals to acquire majority stake in its branded generic business. Strides will pick up global rights of Bafna's flagship brand Raricap through this acquisition. The India-branded generics business of Bafna is valued at Rs 65 crore and the business, in its entirety will be transferred to a special purpose vehicle (SPV), in which Strides will hold 74 percent stake, the company said in a statement. Strides will pay a consideration of Rs 48 crore in cash to Bafna and balance as 26 percent equity participation in the SPV. Intellectual properties (IPs) and manpower will be transferred to the SPV as part of the business transfer and Bafna will continue to manufacture these products for the SPV over a period of five years, and will have global rights for the Raricap brand. Mr Arun Kumar, founder and group CEO of Strides Arcolab, said, "This acquisition provides necessary impetus to our domestic branded generics business and the transaction is in line with our strategy to grow the company's branded business. The transaction will strengthen our reach in newer markets with a wider portfolio of products." This acquisition is also expected to strengthen its women and child care portfolio and Bafna's pan India reach will aid Strides' biggest brand Renerve's entry into new market segments. Bafna's India branded generics business is engaged in sales and marketing of branded pharmaceuticals products in niche theraupetic segments i.e. haematinic, women healthcare, pediatric care. ]]> <![CDATA[SMEs to bear the burnt of govt decision on price control]]> https://biospectrumindia.com/news/95/1693/smes-to-bear-the-burnt-of-govt-decision-on-price-control.html https://biospectrumindia.com/news/95/1693/smes-to-bear-the-burnt-of-govt-decision-on-price-control.html Thu, 24 Jul 2014 13:40:00 +0530 The NPPA has recently fixed prices of 108 formulations of two therapeutic segments, cardiovascular and anti-diabetic, extending price control to non-scheduled drugs. While its impact on the industry has been reported but only partially, believes Mr D G Shah, secretary general of Indian Pharmaceutical Alliance (IPA) who says that its mid and long term impact on the public and the credibility of the government is not adequately covered. "The span of control has increased by almost 50 percent from 13 to 20 percent. The NPPA has made its intention known to bring six more therapeutic segments under price control. This overarching policy enlarging span of control is a major concern of the industry,"mentioned Mr Shah in a note sent to BioSpectrum. Mr Shah mentioned that MNCs generally price their products in the highest bracket, followed by the large Indian companies in the mid-segment and the SMEs in the lowest bracket. "The companies in the highest price bracket having a volume share of about 30 percent are forced to reduce their prices. They will compete in the mid-segment forcing companies in this segment to lower their prices to protect their volume share of about 40 percent. Their lowering the prices will have direct impact on the lowest segment with a volume share of 30 percent. They mainly comprise of SMEs. They would find it difficult to lower their prices further and would thus become victims of the price fixation orders, compressing the band width of prices," says Mr Shah on the basis of the compiled data," he explains in the note. Terming it anti-competitive, Mr Shah says, "Compression of the band width will hurt the SMEs most in the medium term (3 to 5 years). It will also eliminate or reduce the competitive pressure they exert on the high and mid priced segments and will lead to increasing dependence on MNCs." He also talks about the impact on quality and mentions, "The price fixation orders have claimed that products of all manufacturers are similar in quality. Everybody knows that they are not. The reality is that all products, launched after four-years from the first approval in India, by law, are not required to prove bio-equivalence. Hence, those which are not tested for bio-equivalence cannot be said to be similar or "inter-changeable" with the originator's product in terms of quality." "The GMP standards vary from company to company. By no stretch of imagination can one say that all companies in the country have similar GMP standards. They are not. Undue price pressure will tend to compromise both quality and GMP standards adversely, affecting public interest," said Mr Shah. ]]> <![CDATA[Great plans pave way for BIOTaiwan opening]]> https://biospectrumindia.com/news/95/5194/great-plans-pave-way-for-biotaiwan-opening.html https://biospectrumindia.com/news/95/5194/great-plans-pave-way-for-biotaiwan-opening.html Thu, 24 Jul 2014 13:04:55 +0530 With the two-day BioBusiness Asia conference (BBA) leading the way, Taipei's annual festival that brings together the best of all worlds under one roof - BIOTaiwan 2014 was inaugurated with massive interest and participation. A total of 700 bio companies, 1,200 exhibitors and over 1,00,000 visitors winessed the opening ceremony that had many pioneers in the industry being felicitated for their dedicated work. The event was opened was Taiwan's Vice President, Mr Wu Den-yih who further enhanced the vision, by visiting all the stalls and giving ample time to each company he heard from. With this year's theme being 'Connecting to the Global Value Chain', the event kickstarted with the two-day BBA that would focus on partnerships based on the trends in the biosciences industry. The main agenda for this event would be to foster ties between Taiwan and the rest of the world. True to its form since its inception, the event this year too will host prominent speakers from various leading companies so as to make the domestic industry and participants from across the world aware of the possibilities of growth. The growing bio-based economy in the Asia-Pacific region will be the key topic of discussion in the first part of the conference. This event will be lead by addresses by Mr David Flores, CEO, Biocentury, Dr Ross Horsbury, Senior Vice President of Asia, Quintile's, Senior Vice President Mr Christopher Fang of DePuy Synthes at Johnson & Johnson and Mr Yiu-Lian Fong, Division Vice President of R&D at Abbott Molecular. The event has brought together thousands of stakeholders of the life sciences industry, who will be tracking not just domestic but also global biotech industry trends at the event. Amongst the countries participating in the event, USA, Japan, China, South Korea, New Zealand and Australia had active pavilions where discussion and one-on-one collaborations were witnessed. Further, the event also has a series of seminars lined up titled, 'Biotech opportunities and challenges in the Asia-Pacific Region, 'Win-win partnerships through global alliances' and 'Successful strategies for biotech IPO in Taiwan.' ]]> <![CDATA[Sun pharma-Ranbaxy deal gets BSE and NSE nod]]> https://biospectrumindia.com/news/95/7685/sun-pharma-ranbaxy-deal-gets-bse-and-nse-nod.html https://biospectrumindia.com/news/95/7685/sun-pharma-ranbaxy-deal-gets-bse-and-nse-nod.html Wed, 23 Jul 2014 17:53:39 +0530 The $4 billion merger of Ranbaxy Laboratories with Sun Pharmaceutical Industries has received clearance from two of India's leading stock exchanges, BSE and NSE. This has removed a regulatory hurdle in the country's largest in-bound pharma deal. A 'no-objection' from the two exchanges would allow the two companies to file their merger scheme with a High Court for further clearance of the deal. This marks one of the numerous regulatory approvals that Sun Pharma and Ranbaxy need to complete, for the transaction to go through. This approval will also allow Sun to delist Ranbaxy's shares from the two exchanges. The two companies will still need clearances of the high courts of Gujarat, Punjab and Haryana, besides the Competition Commission of India to close the deal. After the takeover is complete, the combined entity will be the fifth largest generic firm globally with annual sales of over $4.2 billion. ]]> <![CDATA[Awareness, Improved policy framework, Use of IT crucial concludes 2nd NCD Summit]]> https://biospectrumindia.com/news/95/8283/awareness-improved-policy-framework-use-of-it-crucial-concludes-2nd-ncd-summit.html https://biospectrumindia.com/news/95/8283/awareness-improved-policy-framework-use-of-it-crucial-concludes-2nd-ncd-summit.html Wed, 23 Jul 2014 12:35:49 +0530 Confederation of Indian Industry (CII), in partnership with Eli Lilly and Company (Lilly) released a national white paper on tackling NCDs (Non Communicable Diseases) within Public Sector Enterprises (PSEs) at the 2nd National NCD Summit 0n July 18, 2014. Guest of honor, Dr APJ Abdul Kalam, former president of India was present to release the White Paper. The Summit was aimed at creating a national level platform to strengthen and help shape public health strategies for comprehensive diabetes management, particularly amongst Public Sector Enterprises. The initiative hopes to address the larger objective of making India better prepared to combat the rising burden of diabetes. "Non-communicable diseases take a heavy toll on human lives and also affect economic productivity. Taking the right steps now will help organizations plan better for the health of their employees leading to higher efficiency and productivity in the long run." said Ms Shobana Kamineni, chairperson, National Committee on Public Health, CII. The White Paper was developed on the basis of the recommendations that emerged from roundtable discussions held in cities with a strong PSE presence such as Hyderabad, Kolkata, Mumbai, Bangalore and Raipur. These roundtables saw participation from PSE medical directors, health professionals and industry experts. Key insights from these consultations were compiled, analyzed and actionable recommendations were developed which were then presented at the National NCD Summit 2014. Speaking on the occasion, Dr Kalam said "Rapid economic development in Asian countries, particularly India has led to a shift in health problems from communicable diseases to non-communicable diseases with diabetes and cardio-vascular diseases leading the list. I am very glad that PSUs are adopting measures to take care of their employees' health, infact a 'Diabetes Free Employees' movement should be started in organizations. I hope that these collaborative efforts will help in better prevention and management of the disease for all." Some of the participating PSEs included BHEL, ONGC, NTPC, IOCL, Bharat Dynamics, Singareni Colliaries, NGRI, South Central Railways and APSRTC. "Non-communicable diseases constitute a very large spectrum of the overall disease scenario of the country. The diseases that come within this gamut are diabetes, hypertension, coronary heart diseases and cancer, which to a large extent are preventable. There are already 60 million diabetes patients in India and in the next 15 years this number can go up to 100 million. We can certainly control these diseases if we know the preventive strategies and early diagnosis is key. The healthcare delivery system can be improved if everyone contributes." said Dr Harsh Vardhan, union minister of health and family welfare. The summit sensitized stakeholders on policies and practices for NCD control with a special focus on diabetes. It facilitated learning and sharing of best practices and trends to strengthen diabetes management in PSEs. Edgard Olaizola, Managing Director of Lilly India said "There are close to 254 central Public Sector Units (PSUs) employing over 14.44 lakh people in India and the burden of non-communicable diseases in these organisations is high. We see this initiative as a first step in helping the country's largest business sector tackle the management of NCDs. We are committed to reducing the diabetes burden in India and globally, and are happy to take this initiative forward." Below are some of the highlights from the joint recommendations given by the various PSEs which have been published in the National Whitepaper 2014: --Adopting a 'healthy environment' e.g. no convenience machines, taking activity breaks, encourage walking, availability of healthy food choices in canteens, integrating health clinics with gyms and fitness centers --Develop a common framework for the NCD policy in consensus with PSEs and other stakeholders --Develop and promote nutrition policies in PSEs to limit content of sugar in food and non-alcoholic beverages; limit excess calorie intake and reduce portion size and energy density of foods --Design new policy/guideline or revisit and reframe existing health policies for screening and diagnosis of NCDs at the workplace. --Conduct Periodic Medical Examination (PME) for employees, ensure regular follow up based on age and location in line with the advice of the treating physician --Organize Continuing Medical education (CME) programs in PSEs for healthcare providers to address provider attitudes toward diabetes and update knowledge. Organize standardized orientation programs for the medical team managing NCDs in PSEs --Create a standardized and integrated IT system to manage a diabetes registry to generate reports for analyzing a patient's key diabetes-related measures and help track patient's progress. --Collaborate with government agencies, premier medical and technical institutions to utilize already existing Information and Communication Technologies (ICT) platforms like telemedicine ]]> <![CDATA[With GEAC back in action, govt pushes for field trials of GM crops]]> https://biospectrumindia.com/news/95/5149/with-geac-back-in-action-govt-pushes-for-field-trials-of-gm-crops.html https://biospectrumindia.com/news/95/5149/with-geac-back-in-action-govt-pushes-for-field-trials-of-gm-crops.html Wed, 23 Jul 2014 08:30:00 +0530 The Genetic Engineering Approval Committee (GEAC), under the MoEF has, so far, cleared 60 proposals for the GM crops at various stages of trials this year. In a meeting of the GEAC held recently, the committee took up the proposals that were pending over the past year. The meeting was also attended by representatives of respective companies. The GEAC has cleared trials of 15 GM crops for stage one trials on a one-acre plot. There are as many as 20 GM crops already undergoing trials at various stages. As per reports, the proposals cleared recently were for Rabi crops while the cases of Kharif crops were cleared in previous rounds of meetings. It is worthwhile to note that the committee had not met between March 2013 and March 2014 but has now already met thrice since then. BioSpectrum in an exclusive report in its March issue, had reported about the failure of the two previous environment ministers to hold a balanced view on the matter as well as clear scientific evaluation on the issue. A Supreme Court technical expert committee had last year recommended an indefinite moratorium on the field trials of GM crops till the government came out with a proper regulatory and safety mechanism. The Parliamentary Standing Committee on Agriculture, in a report in August 2012, had asked for a ban on GM food crops in the country. There has been an ongoing debate over the introduction of GM crops, with one huge lobby of activists, farmers and political parties opposing it and calling it unsafe. At the same time, the government agriculture ministers, public and private scientists were batting for it and saying that it is important for the country's food security. In India, so far, cotton is the only GM crop which is legally allowed for commercial release and there is a moratorium on bt brinjal since February, 2010. It was placed by the then environment minister Mr Jairam Ramesh, following a protest from civil society activists. ]]> <![CDATA[Japanese encephalitis kills 60 in West Bengal]]> https://biospectrumindia.com/news/95/3978/japanese-encephalitis-kills-60-in-west-bengal.html https://biospectrumindia.com/news/95/3978/japanese-encephalitis-kills-60-in-west-bengal.html Tue, 22 Jul 2014 17:01:23 +0530 An outbreak of Japanese encephalitis has killed 60 people in West Bengal. A total of 344 people have been affected by the disease, as per reports. The region is affected badly and the situation is alarming. Mr Biswaranjan Satpathy, the state's health services director informed that the Bengal Medical College does not have the facilities needed to test other forms of encephalitis. Jalpaiguri district is worst hit by the disease. Dhupguri and Moynaguri rural areas are the most affected because of the large number of piggeries from where Japanese encephalitis spread. Mr Satpathy said that the number of deaths due to the deadly disease is much higher this year than in 2013 when the figure was only five. To tackle the rush of patients at the North Bengal Medical College and Hospital, two doctors have been posted round the clock at the outpatient section of the fever clinic of the hospital. The state health department has decided to set up fever clinics and relocate pig farms in the districts in the grip of vector-borne disease. ]]> <![CDATA[Farmer groups hail government decision on field trials of GM crops]]> https://biospectrumindia.com/news/95/5857/farmer-groups-hail-government-decision-on-field-trials-of-gm-crops.html https://biospectrumindia.com/news/95/5857/farmer-groups-hail-government-decision-on-field-trials-of-gm-crops.html Tue, 22 Jul 2014 14:56:56 +0530 National Farmers' Empowerment Initiative (NFEI), an umbrella organization representing many farmer organizations across the country, has complimented prime minister, Mr Narendra Modi for taking the very progressive decision of allowing field trials of GM crops. Hailing this decision as progressive and long overdue, president of NFEI and Punjab farmer, Mr PPS Pangli termed the judgment as an affirmative reiteration of Modi Government to ensure that benefits of progressive technology reach country's farmers. The ministry of environment and forest (MoEF) had on July 18, cleared field trials for 15 GM crops which include major crops such as rice, chickpea and brinjal among others. The Genetic Engineering Approval Committee (GEAC) under the MoEF took up the proposals for field trials which have been pending for over one year. The committee had not met between March 2013 and March 2014. "R&D is integral to the infusion of modern technology in agriculture. Unfortunately, the decision on field trials had become a victim of political interference and insensitivity of the UPA Government towards farmers",said Bihar farmer and president of Pragatisheel Krishi Manch, Mr Kishore Jaiswal. The manch works with farmers across Bihar, West Bengal, Odisha and UP. He further added, as per a global report, more than 18 million farmers in 27 countries planted biotech crops in 2013, reflecting a five million, or 3 percent, increase in global biotech crop hectarage. In the present scenario, R&D activities of both the public and private sectors have been put on hold since 2010, causing enormous delay in making these technologies available to farmers, he said. "Trait development through Genetic Modification is at various stages of research, being conducted in more than 9 crops and 50 events in various parts of the country. More than 50 percent of these research projects are in public institutions where hundreds of crores has been invested by the Government," said Mr S Jaipal Reddy of Pratap Rudra Farmers Society, Warangal. National award winning farmer and leader, Mr Sudhanshu Kumar added, "India has adequate safeguards in bio-safety and food safety already built into the existing system. Only after thorough testing at different stages with great care and regulatory oversight, GM crops are authorized for commercial cultivation. Field trials form a part of this process, to ensure that the efficacy of the genetically modified seeds are scientifically evaluated and data is generated which helps us understand the efficacy and the utility." ]]> <![CDATA[AIDS 2014: HIV Alliance raises human rights issue]]> https://biospectrumindia.com/news/95/3885/aids-2014-hiv-alliance-raises-human-rights-issue.html https://biospectrumindia.com/news/95/3885/aids-2014-hiv-alliance-raises-human-rights-issue.html Tue, 22 Jul 2014 14:49:25 +0530 At the 20th International AIDS Conference (AIDS 2014) being held in Melbourne from July 20th-25th, India HIV/AIDS Alliance is highlighting the vulnerability of marginalised populations with HIV infection that are stigmatised, discriminated against and criminalised and thus devoid of human rights and essential access to basic health services. Focus IssuesAdvocacy against Section 377 of the Indian Penal CodeThe Indian Supreme Court recriminalized same-sex behaviour between consenting adults in December 2013, a reversal of the Delhi High Court ruling five years ago that legalised homosexual behaviour is an obstacle to fulfilling the basic human rights of these populations already underground and highly vulnerable to the epidemic. Expanded Attention on Women who Inject DrugsWomen who inject drugs in India remain largely neglected in the current HIV response. Marginalised and at risk, these women have inadequate access to services and information they need to protect their health and wellbeing. Unsafe sexual behaviour and shared injecting equipment increase their risk for HIV and hepatitis C infection. Massive Scale-up of Care & Support for PLHIV in IndiaHIV treatment is a lifelong commitment. As more people get on treatment in India and elsewhere, it becomes increasingly urgent to ensure that people living with HIV on treatment are provided the care and support they need to thrive. India has committed to getting more than one million PLHIV on treatment by the end of 2015. This will require a scale-up of ART Centres and related expansion of care and support across the country. Investing in the HIV & AIDS Response: A Gap for Communities and Civil Society After South Africa and Nigeria, India has the world's third highest caseload with 2.1 million people living with HIV. As international funders reduce investments in Middle Income Countries, it is expected that national governments, including India, should step up to fund the response to HIV/AIDS. While the Government of India has committed to a budget in which it covers 75 percent of the cost of the new national strategy with domestic funds, actual spend is difficult to monitor. Although the country has made great progress in the last decade, there is growing evidence that the epidemic is no longer stable with increasing HIV incidence in areas of the country earlier considered low prevalence. ]]> <![CDATA[Intas launches indigenous 'Azadine' for cancer]]> https://biospectrumindia.com/news/95/3851/intas-launches-indigenous-azadine-for-cancer.html https://biospectrumindia.com/news/95/3851/intas-launches-indigenous-azadine-for-cancer.html Tue, 22 Jul 2014 12:23:27 +0530 Intas Pharmaceuticals has become the first Indian company to indigenously develop an Azacitidine molecule. Intas's Azadine will benefit millions of Indians suffering from MDS (Myelodysplastic Syndrome) and AML (Acute Myelogenous Leukemia) types of cancer as the treatment cost has been drastically brought down to a fifth of its imported variant (which is currently in use). â€œIt is estimated that 4-5 people per 100,000 suffer from MDS/AML. Data from global epidemiologic studies suggest that the disease burden of MDS in India is likely to be sizeable. Also, cytogenetic studies suggest that MDS patients in India get affected by the disease at a younger age and also tend to have a higher risk. With the launch of Azadine, we further reinforce our commitment towards making quality healthcare affordable and accessible to maximum number of Indians,â€? said Dr Vijayesh Gupta, head, Marketing and Sales, Intas Pharmaceuticals, India. MDS is a type of cancer in which the bone marrow does not make enough healthy blood cells and there are abnormal (blast) cells in the blood and/or in the bone marrow. Advanced stages of MDS may lead to AML. Azacitidine (effective molecule in Azadine) is the only drug which has been shown to prolong overall survival duration and time for the transformation into AML, increase response rate, reduce transfusion burden and improve quality of life. There is no need for the patient to get admitted to a hospital, due to subcutaneous administration of the drug, which is an OPD procedure. As there is little impact on lifestyle and fewer hospital visits, this drug ensures higher patient compliance. Currently, for combating this type of Cancer in the country, oncologists have to rely on an imported version of Azacitidine. The treatment cost of imported Azacitidine can range between Rs 15-18 lakhs. The cost of other treatment options which range from conventional agents to transplant, may cost anywhere between Rs 2-15 lakhs. With an objective to make it accessible to most of the needy patients, Azadine has been priced at 20 percent of the imported brand. Azacitidine molecule induces antineoplastic activity via two mechanisms; inhibition of DNA methyltransferase at low doses, causing hypomethylation of DNA, and direct cytotoxicity in abnormal hematopoietic cells in the bone marrow through its incorporation into DNA and RNA at high doses, resulting in tumourous cell death. Azacitidine has been approved by the US FDA since May 2004. Azadine is manufactured in the state of the art, Intas SEZ facility in Ahmadabad, Gujarat which is spread over 35,565 sq. mts. The plant has dedicated manufacturing facilities for cytotoxic formulations (Tablet, Capsule, Liquid Injection, Lyophilized Injection, and Ointment) and Other Oral Solids. This plant operates in compliance with global regulatory standards like USFDA, MHRA and ANVISA. ]]> <![CDATA[Pre-filled pen injector for adults with type 2 diabetes ]]> https://biospectrumindia.com/news/95/3698/pre-filled-pen-injector-for-adults-with-type-2-diabetes-.html https://biospectrumindia.com/news/95/3698/pre-filled-pen-injector-for-adults-with-type-2-diabetes-.html Tue, 22 Jul 2014 12:06:15 +0530 An innovative technology promises to improve treatment for diabetes patients. The product design and development firm Cambridge Consultants has worked with AstraZeneca to develop BYDUREON® Pen (exenatide extended-release for injectable suspension) 2 mg - which received US Food and Drug Administration (FDA) approval in February. BYDUREON is the first once-weekly medicine as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes. The BYDUREON Pen is a pre-filled, single-use pen injector - eliminating the need for the patient to transfer the medication between a vial and syringe during the self-injection process. The exenatide microspheres and diluent are housed in separate chambers within the pen device and only mixed at the time of injection. Cambridge Consultants used their industrial design and human factors expertize in developing the usability of the BYDUREON Pen. The design guides the patient to the right place to grip the pen - and leads them to naturally hold the device at the correct angle that enables the drug to be mixed properly before injection. The design includes 'windows' which show the mixing process inside the pen injector - to focus the user's attention on this key element of the process. "Our objective was to make the whole procedure as simple as possible, eliminating the need for the patient to transfer the medication between a vial and syringe during the self-injection process," said Mr Andy Pidgeon, head of the industrial design and human factors group at Cambridge Consultants. "We carried out extensive usability testing to ensure that both patients and healthcare professionals were able to successfully use the BYDUREON Pen." An emerging global epidemic of diabetes is placing a huge burden on healthcare services. An estimated 347 million people worldwide suffer from the disease. The World Health Organization predicts that, by 2030, diabetes will be the seventh leading cause of death. ]]> <![CDATA[Significant surge in biofertilizer production in India ]]> https://biospectrumindia.com/news/95/3835/significant-surge-in-biofertilizer-production-in-india-.html https://biospectrumindia.com/news/95/3835/significant-surge-in-biofertilizer-production-in-india-.html Tue, 22 Jul 2014 11:56:15 +0530 The government is promoting the production of biofertilizers in the country through various programs under National Mission on Sustainable Agriculture (NMSA), Mission for Integrated Development of Horticulture (MIDH), Rashtriya Krishi Vikas Yojna (RKVY) and Network Project on Organic Farming under Indian Council for Agricultural Research (ICAR). This information was provided by Dr Sanjeev Kumar Balyan, minister of state for agriculture and food processing industries in the parliament on July 18, 2014. The minister further revealed that under soil health management (SHM) component of NMSA, financial assistance upto 50 percent of the cost subject to a limit of Rs 5,000/- per hectare and Rs 10,000/- per beneficiary is provided for the promotion of organic or chemical free inputs on a farmers' field. Under the SHM component of NMSA, financial assistance of upto 33 percent of the financial outlay, with a ceiling of Rs 63 lakhs is provided as back-ended subsidy through NABARD for establishment of agro / vegetable waste compost production units. Assistance has been provided for 56 nos. of Bio-fertiliser production units and 17 nos. of fruits/ vegetables agro-waste compost units have been established under the scheme. Under the Mission for Integrated Development of Horticulture (MIDH), financial assistance for establishing vermi compost units and HDPE Vermi beds is at 50 percent of the cost, subject to a maximum of Rs 50,000/- per beneficiary for a unit having size of 30'x8'x2.5'. For smaller units assistance is on prorate basis. For HDPE Vermi bed of 96 cft size (12'x4'x2'), the assistance is Rs 8,000/- per bed. "Indian Council of Agricultural Research (ICAR) has developed a technology for the preparation of enriched / vermi compost from various organic wastes. All India Coordinated Research Project on Soil Test Crop Response (AICRP-STCR), under the aegis of ICAR has developed a soil test based fertilizer prescription model to achieve a desired yield target taking due consideration of crop nutrient requirements and contribution from soil and fertilizers. The information for 15 States covering different crops have been uploaded onto IISS Website: http://www.iiss.nic.in/STCR%202014.pdf," revealed the minsiter. ]]> <![CDATA[Govt takes steps to contain anti-microbial resistance]]> https://biospectrumindia.com/news/95/7844/govt-takes-steps-to-contain-anti-microbial-resistance.html https://biospectrumindia.com/news/95/7844/govt-takes-steps-to-contain-anti-microbial-resistance.html Mon, 21 Jul 2014 18:41:53 +0530 Concerns have been expressed with respect to the development of antimicrobial resistance in pathogens, even to the newer, more potent anti-microbial drugs, on account of increased availability and use of antibiotics across the country. A Task Force was constituted by the government to recommend measures to address the problem of multi-drug resistance arising out of the widespread and indiscriminate use of antimicrobial drugs in the country, and to assess, review and suggest measures on anti-microbial resistance. The Task Force recommended various steps to rationalize the use of antibiotics in the country. The recommendations include inter alia, a separate Schedule under the Drugs and Cosmetics Rules to regulate the sale of antibiotics. The Drug and Cosmetics Rules, 1945 have since been amended vide Gazette Notification No GSR 588 (E) dated August 30, 2013 incorporating a new, namely, Schedule H1 under the Drugs and Cosmetics Rule containing 46 drugs which include antibiotic drugs, anti TB drugs and certain habit forming drugs. The drugs falling under Schedule H1 are required to be sold in the country with the following conditions: (1) The supply of a drug specified in Schedule H1 shall be recorded in a separate register at the time of the supply giving the name and address of the prescriber, the name of the patient, the name of the drug and the quantity supplied and such records shall be maintained for three years and be open for inspection. (2) The drug specified in Schedule H1 shall be labelled with the symbol Rx which shall be in red and conspicuously displayed on the left top corner of the label, and shall also be labelled with the following words in a box with a red border. As a part of its global program, the WHO Secretariat is in the process of the development of a draft global action plan on antimicrobial resistance and is now inviting contributions from all relevant organizations, institutions, networks, civil society groups, national authorities and ministries through an online consultation. ]]> <![CDATA[India unveils genetic blueprint of bread wheat genome]]> https://biospectrumindia.com/news/95/7757/india-unveils-genetic-blueprint-of-bread-wheat-genome.html https://biospectrumindia.com/news/95/7757/india-unveils-genetic-blueprint-of-bread-wheat-genome.html Mon, 21 Jul 2014 16:25:10 +0530 Scientists from ICAR's National Research Center on Plant Biotechnology (NRCPB), New Delhi, Punjab Agricultural University (PAU), Ludhiana, and Delhi University South Campus (DU) in collaboration with International Wheat Genome Sequencing Consortium (IWGSC) have published a chromosome based draft sequence of the bread wheat genome in top international journal Science (18 July 2014). This is a moment of pride for the country, as it is a part of an international effort to decode one of the world's most important food crops. India is entrusted with the responsibility of decoding wheat chromosome '2A', which alone has a genomic DNA code of about 900 million base pairs (or letters), that is about two and a half times the size of whole rice genome, and about one third of the size of the human genome. The full wheat genome is about six times the size of human genome. The Indian initiative was financially supported by the Department of Biotechnology, ministry of science and technology, government of India at a total cost of Rs 35 crore. Earlier, Indian scientists had helped crack the genetic code of rice and tomato as part of the international consortia and also succeeded in decoding the pigeon pea (Arhar) and chickpea (Chana) genomes entirely on their own. Wheat was considered one of the hardest crop plants to decode due to its huge genome size of 17000 million base pairs, and the presence of three sets of highly similar chromosomes in the genome. However, technological advances made in recent years and availability of specialized genetic stocks developed during 1950s in wheat variety 'Chinese Spring' made it possible to isolate individual wheat chromosomes for sequencing. The chromosome-based draft sequence provides new insight into the structure, organization and evolution of the large complex genome of the world's most widely grown cereal crop. The decoding of wheat genome has identified more than 125,000 genes assigned to the individual wheat chromosomes. ]]> <![CDATA["NPPA an independent body authorized to fix drug prices"]]> https://biospectrumindia.com/news/95/7658/nppa-an-independent-body-authorized-to-fix-drug-prices.html https://biospectrumindia.com/news/95/7658/nppa-an-independent-body-authorized-to-fix-drug-prices.html Mon, 21 Jul 2014 16:09:24 +0530 National Pharmaceutical Pricing Authority (NPPA) is an independent body of experts which has been delegated with the powers under DPCO, 2013 to fix the ceiling price or retail price of any drug. This was stated in reply to a question in the parliament recently by the minister for chemicals and fertilizers, Mr Ananth Kumar. He remarked that NPPA has fixed the prices of anti-diabetic and cardiovascular drugs with respect to 108 non-scheduled formulations. The minister said that all the medicines specified in the National List of Essential Medicines, 2011 (NLEM, 2011) have been included in Schedule 1 of the Drugs (Prices Control) Order, 2013 (DPCO, 2013) which contains 348 drugs covering 680 formulations. ]]> <![CDATA[Eli Lilly to expand its diabetes portfolio]]> https://biospectrumindia.com/news/95/3221/eli-lilly-to-expand-its-diabetes-portfolio.html https://biospectrumindia.com/news/95/3221/eli-lilly-to-expand-its-diabetes-portfolio.html Mon, 21 Jul 2014 14:27:47 +0530 With an aim to enhance its diabetes treatment portfolio in one of Asia's top markets, US based pharma major Eli Lilly is planning to launch a new product. To be launched by the end of next year, the company is now awaiting regulatory approval for the new product. Mr Edgard A Olaizola, managing director, Eli Lilly and Company India said in a media statement, "We expect to launch a new product in the diabetes segment in India by the end of 2015. It has been submitted for regulatory approval." He added that diabetes is a core segment for the company in India. "Early in the year, we had introduced Savvio, an insulin delivery device in India. The launch of Savvio marked an important milestone for the company," Mr Olaizola pointed out. The company also said that in January this year they launched Humapen Savvio, its original research product in India. "It is a very important market for the company in Asia specially in diabetes. Though the biggest markets for the company globally are the US, Europe and Japan," he said. Currently, the Indian wing of the US based company has products available to treat diabetes, cancer, cardiovascular diseases, osteoporosis and growth disorders in the country. Commenting on the expected growth in the Indian sub-continent, Mr Olaizola said, "We are very happy with the performance we have made in India in the last two to three years, especially in diabetes. Our vision is to be a powerhouse in diabetes." ]]> <![CDATA[Neuclone inks pact with Serum Institute of India ]]> https://biospectrumindia.com/news/95/7921/neuclone-inks-pact-with-serum-institute-of-india-.html https://biospectrumindia.com/news/95/7921/neuclone-inks-pact-with-serum-institute-of-india-.html Sat, 19 Jul 2014 18:30:00 +0530 According to a recent company statement, the partnership would leverage NeuClone's patented technology to generate protein drugs at much reduced cost from proprietary manufacturing cell lines and the immense biologics manufacturing capability of Serum Institute, the world's largest vaccine producer. The products would treat diseases including cancer and autoimmune disorders. "After several years of technology development and building our team expertise, NeuClone is very pleased to launch this multi-product co-development programme with Serum Institute. Our products will exemplify the competitive advantages of our NeuMAXTM technology platform for cell line development", said Mr Noelle Sunstrom, NeuClone's founder and CEO. Serum Institute has exclusive licence for marketing and sales for India, China, South East Asia, The Middle East, South America and Africa. "We plan to extend the vision set by Dr C S Poonawalla to develop bio-similar monoclonal antibodies at an extremely affordable cost through this collaboration, " Mr A C Poonawalla, CEO and executive director, Serum Institute of India, said. Mr Umesh Shaligram, Serum Institute's director of R&D said "For this new strategic initiative in the bio-similar monoclonal antibodies market we are combining our extensive biologics manufacturing and distribution expertise and cost advantages with NeuClone's technology for high quality and low cost of goods." The partnership will have multiple products in development simultaneously such that all 10 products will transition through clinical trials and enter the market. ]]> <![CDATA[Friends share DNA similarities: Study]]> https://biospectrumindia.com/news/95/5442/friends-share-dna-similarities-study.html https://biospectrumindia.com/news/95/5442/friends-share-dna-similarities-study.html Sat, 19 Jul 2014 12:15:00 +0530 Bangalore: A latest study conducted by researchers from the University of California, San Diego has suggested that friends share DNA similarities. The study suggest that you may be more similar to your friends than you think. It explains how the DNA code tends to be more alike between friends than between strangers. This, researchers pointed out is beyond the effect of shared ethnicity. One of the lead researcher Mr James Fowler from the University of California said that this can be important for theories about human evolution. Mr Fowler, along with Yale researcher Mr Nicholas Christakis presented their findings in a paper that was released by the Proceedings of the National Academy of Sciences. The research included 1,932 participants in a long-running health study in Framingham, Massachusetts. A report explained that the researchers knew who was close friends with whom from the 1970s to the early 2000s because of information gathered for the study. From this group, they identified 1,367 pairs of close friends and about 1.2 million pairs of strangers. Then they examined information about nearly 467,000 locations in the DNA code of each participant. They looked for how similar the friend pairs were, and compared that to how similar the stranger pairs were. One of the first observation that the researchers made was that genes affecting sense of smell were especially likely to be similar in friends. When questioned about why friends would have more DNA similarities than strangers, Mr Fowler said, "One possibility is that similar genes nudge people toward similar environments, which then gives them a chance to meet. Another possibility is that people who share certain genes also share skills that become more valuable when the people work together." This, he added could have been important over evolutionary time, setting up a pattern that people still follow. Mr Fowler also pointed out that it's not clear whether the finding pertains to groups outside of the Framingham study group, which is overwhelmingly Irish and Italian. In any case, findings of DNA similarities between friends could help explain how behaviors like altruism developed over evolutionary time, he said. ]]> <![CDATA[Strides invests in US-based Oncobiologics]]> https://biospectrumindia.com/news/95/3243/strides-invests-in-us-based-oncobiologics.html https://biospectrumindia.com/news/95/3243/strides-invests-in-us-based-oncobiologics.html Fri, 18 Jul 2014 16:36:12 +0530 Oncobiologics is working on a bio-similar of blockbuster drugs like Humira, a rheumatoid arthritis drug patented by Eli Lilly, as well as copies of Avastin and Herceptin. Strides was attracted by Oncobiologics' business model. However, the financial details of the strategic investment are not disclosed. "After significant due diligence, it is evident that their success to date in meeting technical milestones is an indicator of the solid team and business model they have constructed," said Mr Arun Kumar, Strides' chief executive. "Strides' investment in Oncobiologics is a part of its strategy to fund promising bio-pharma research companies that have a novel approach to developing such drugs, saving cost and time," the company said. Development of biological drugs, which hold tremendous commercial potential and promise new therapeutic options for diseases such as cancer, typically involve difficult processes, high cost and longer time. ]]> <![CDATA[Four Pharma companies get licenses for anti-HIV drugs]]> https://biospectrumindia.com/news/95/3852/four-pharma-companies-get-licenses-for-anti-hiv-drugs.html https://biospectrumindia.com/news/95/3852/four-pharma-companies-get-licenses-for-anti-hiv-drugs.html Fri, 18 Jul 2014 16:19:00 +0530 Medicines Patent Pool(MPP), a United Nations-backed organization that facilitates cheaper HIV treatment in developing countries, has announced a fresh agreement to manufacture two anti-Aids medicines with seven generic drug makers, four of which are Indian firms, which are Aurobindo, Cipla, Emcure and Micro Labs. MPP does sign agreements with innovator companies to share new drug patents in a pool that can be accessed by generic companies to manufacture and sell cheaper versions of those anti-HIV drugs. And generic companies seek sub-licenses for these drug patents. In the latest agreement, four Indian companies were given manufacturing licenses for next generation or second line anti-HIV treatments - Bristol Myers Squibbs' atanazavir and ViiV Healthcare's dolutegravir. The WHO estimates that there will be more than one million people on second-line treatment by 2016 and many more will need access to the same. MPP currently has nine anti-HIV drug patents in its pool and ten generic manufacturing sub-licensees. Indian firms Aurobindo and Emcure have been associated with MPP and have 5-6 anti-HIV drug licenses. The new agreement to manufacture atanazavir adds to their existing portfolio. Cipla has also made an entry to MPP with a license for dolutegravir. This adds to their anti-HIV portfolio and exports. The agreement will help generic companies expand market size for these advanced AIDS therapies in developing countries of Africa and South Asia. These are markets where the drugs will be priced quite low, but with a large AIDS burden, these low income countries offer huge volumes. It also helps them avoid the hassle of seeking voluntary licenses from innovator firms or applying for compulsory licenses in those markets. Till then generic companies will benefit from increased exports to and penetrations in other big anti-HIV markets. ]]> <![CDATA[Search on for filling DG-CSIR, Secy-DST posts]]> https://biospectrumindia.com/news/95/3544/search-on-for-filling-dg-csir-secy-dst-posts.html https://biospectrumindia.com/news/95/3544/search-on-for-filling-dg-csir-secy-dst-posts.html Fri, 18 Jul 2014 09:40:31 +0530 Finally the government has decided to take a call on filling the top scientific leadership positions in India. It has initiated a search for a suitable person to serve as the secretary to lead the Department of Science and Technology (DST) and as a major visionary contributor in shaping the future of Indian Science, Technology and Innovation (STI). As per notification from Cabinet Secretariat, the nominations of suitable candidates have been invited from thought leaders of the Indian STI sector. The nominee is expected to connect the cause of the Indian STI sector with resources and be an innovation leader working at the interface areas of governance, public policy, society and science. The government has also initiated a search process for the selection of a suitable candidate for the appointment of director general (DG) of the Council of Scientific and Industrial Research (CSIR) and who will also be the secretary to the government of India, Department of Scientific and Industrial Research (DSIR) . The DG-CSIR is a coveted scientific position with a key role in the transformation of industrial research and development in the country. Therefore, the nominations have been invited from thought leaders in the the Indian science and industrial sectorwith a focus on R&D in application and technology related areas. The nominations for these top positions can be sent directly to Cabinet Secretariat, New Delhi. Established on May 03, 1971, DST has emerged as a nodal department of the Government of India (GoI) for building national capacity and capability in Science, Technology and Innovation (STI). DST is an important extramural funding agency for scientific research in India. DST nurtures 26 competitive research institutions through grants-in-aid, promotes innovations and entrepreneurship, engages in science communication and promotion of scientific temper and aggressively pursues the social contract of S&T. In short, DST strives to add foundational values for the Indian STI sector with a focus on excellence and relevance. The CSIR, was established on September 26,1942 as India's premier chain of national laboratories. In 2014, CSIR has emerged as a chain of 38 laboratories located across the length and breadth of India with about 3900 scientists and total staff and student strengths of 16000 and 5000, respectively. CSIR is India's flagship for industrial research and development and holder of the largest number of patents and other intellectual properties in force. ]]> <![CDATA[Global Disease Detection Centre (GDD) operations in progress]]> https://biospectrumindia.com/news/95/5241/global-disease-detection-centre-gdd-operations-in-progress.html https://biospectrumindia.com/news/95/5241/global-disease-detection-centre-gdd-operations-in-progress.html Fri, 18 Jul 2014 08:30:00 +0530 A memorandum of understanding on the establishment and operation of Global Disease Detection Centre (GDD) in India between Centers for Disease Control and Prevention, Atlanta, the United States of America and National Center for Disease Control, ministry of health and family welfare, Government of India has already been signed on November 06, 2010. GDD - India Center is operative since April 2011. The MoU envisages cooperation and collaboration in areas such as epidemiological strengthening including surveillance and response to epidemic prone diseases and Emerging Infectious Diseases; strengthening public health laboratory capacity and strengthening public health work force capacity to tackle Pandemic flue and other diseases. ]]> <![CDATA[Not enough for SME innovators in the union budget ]]> https://biospectrumindia.com/news/95/3766/not-enough-for-sme-innovators-in-the-union-budget-.html https://biospectrumindia.com/news/95/3766/not-enough-for-sme-innovators-in-the-union-budget-.html Thu, 17 Jul 2014 09:37:00 +0530 While the government has now removed the tax on services by way of technical testing or analysis of new developed drugs, on human participants, Dr Jitendra Verma believes that instead there should be funding of trials for crucial diseases, done especially by small companies. "Clinical trials by innovators for translational research must be encouraged by timely approvals and funding support by the government," he told BioSpectrum. On being asked why the government would do it for private entities, he mentioned that for this support, there could be certain social responsibilities that could be fixed and fullifilled by the companies during and after succesful product development. Dr Verma, who is a renowned name in liposomal research, is of the opinion that the drugs and pharmaceutical research program (DPRP) of Department of Science and Technology (DST) must be strengthened. On the Rs 10,000 crore fund earmarked in the latest union budget for the purpose of encouraging techno-entrepreneurs, Dr Verma says that there is no clear mention or segregation for various verticals. "Whether those doing product development too would be included in it or not, is not clear. Also, the budgetary allocations for young innovators from colleges or universities to do innovation is missing," says the scientist turned first generation entrepreneur. ]]> <![CDATA[Govt gives nod to research institute for bulk drugs]]> https://biospectrumindia.com/news/95/4447/govt-gives-nod-to-research-institute-for-bulk-drugs.html https://biospectrumindia.com/news/95/4447/govt-gives-nod-to-research-institute-for-bulk-drugs.html Thu, 17 Jul 2014 09:30:39 +0530 To fill the existing crucial gap in Research and Development in bulk drugs, a National Centre for Research and Development in Bulk Drug (NCRDBD) is to be set at NIPER, Hyderabad with a project cost of over Rs 52 crore and with an operating cost of over Rs 37 crore for five years. Approvals for the purpose have been given. The performance of Bulk Drug sector is one of the critical factors that affect the overall efficiency and cost competitiveness of the pharmaceutical sector. There are nearly 2500 bulk drug manufacturing units in India. The estimated turnover of the Bulk Drug Industry in 2012-13 was around $12.5 billion. The industry has shown a Cumulative Annual Growth Rate (CAGR) of 17 percent in the last three years and has a share of about 10 percent of the global bulk drugs market of about $110 billion. However, the import of Bulk Drugs has seen a CAGR of 18 percent during the last three years, indicating an increasing level of dependence on international supply for this critical input of pharmaceutical sector. This is further compounded by the fact that more than 60 percent share in imports of Intermediate for Active PIs is from a single country. The center is to be set up to urgently address these concerns and make the industry cost competitive. In Bulk Drug Industry, the reduced processes and improved technology can help in reducing the cost significantly. The NCRDBD would be an innovative R&D provider in the field of bulk drugs and offer competitive and eco-friendly technologies in specified areas products and processes. This center will also provide centralized research facilities and technologies, analytical facilities and consulting services for process improvement and optimization. It would give special emphasis to the empowerment of MSME sector. ]]> <![CDATA[Pharma companies furious over price control order ]]> https://biospectrumindia.com/news/95/3769/pharma-companies-furious-over-price-control-order-.html https://biospectrumindia.com/news/95/3769/pharma-companies-furious-over-price-control-order-.html Thu, 17 Jul 2014 09:30:00 +0530 The NPPA has identified more drugs used in the treatment of cancer, cardiovascular diseases, diabetics and asthma as well as vaccines for possible price control. As a result of which French drug maker Sanofis' Indian unit will see a loss of Rs 139 crore, or about 30 percent in its sales from cardiovascular and diabetes drugs, according to analysis done by the All India Organisation of Chemists and Druggists. "The NPPA has shocked and disappointed the pharmaceutical industry by issuing a price control order without any consultation and participative dialogue with any industry associations", said Mr Shailesh Ayyangar, managing director of Sanofi India. He added, "The recent notification has shaken the confidence of the industry. It is an incorrect assumption on part of the drug regulator that pharma companies indulge in exploitative pricing. The product categories considered for price control have about 30-70 brand options each across varied price ranges for physicians and patients to choose from. Therefore, the premise that products are not accessible due to affordability is misplaced." Other companies that are hit by this order are Zydus Cadila, Ranbaxy Laboratories, Emcure Pharmaceuticals and the local unit of Abbott. ]]> <![CDATA[Sanofi working to bring dengue under control]]> https://biospectrumindia.com/news/95/3671/sanofi-working-to-bring-dengue-under-control.html https://biospectrumindia.com/news/95/3671/sanofi-working-to-bring-dengue-under-control.html Wed, 16 Jul 2014 17:48:13 +0530 Bangalore: Sanofi announced that the phase III clinical trials for its dengue vaccine was successful, in a press conference held by the company recently. The extensive clinical study proved that the vaccine offered 88.5 percent protection against the disease. The vaccine reportedly worked against all four serotypes of the virus, displaying an effectiveness range from 34.7 percent to 72.4 percent. Sanofi claimed that the vaccine was safe without any side effects. The clinical study involved children in the age group of 2-14 years, who received the vaccine in three injections over a period of six months. Mr Nicholas Jackson, head of dengue vaccine research said, "The vaccine would benefit many people across the globe. Our vaccine has the potential to halve the 50 million to 100 million estimated cases of infections a year and nearly eliminate the estimated 5,00,000 cases that will develop the severe form of the disease." Malaysian Minister of Health Datuk Seri S Subramaniam said, "This is exciting news and could solve the menace of dengue across many Southeast Asian countries. We have planned a few steps to speeden the availability of the vaccine in Malaysia." Sanofi said that it was planning to apply for license for the vaccine early next year ]]> <![CDATA[Sun Pharma acquires US-based Pharmalucence]]> https://biospectrumindia.com/news/95/7647/sun-pharma-acquires-us-based-pharmalucence.html https://biospectrumindia.com/news/95/7647/sun-pharma-acquires-us-based-pharmalucence.html Wed, 16 Jul 2014 17:46:35 +0530 After hitting headlines for its $3.2 billion acquisition of Ranbaxy for months, leading Indian drug maker Sun Pharma has announced its buyout of a US based sterile injectables maker. Pharmalucence is a sterile injectable capacityin the US and Sun Pharma has announced that it will be acquired by one of its subsidiaries. The official statement by the company further said that the Pharmalucence is a leading manufacturer of radiopharmaceuticals and has developed a few injectables indicated for cancer treatment. It added that Pharmalucence is engaged in contract and private label formulation development and manufacturing services of non-cytotoxic human injectables in either liquid or lyophilized form. The statement further pointed out that in mid-2007, Pharmalucence was created via the management buy-out of CIS-US. Further, in 2011 and 2012, Pharmalucence received FDA approval for two new indications for its Sulfur Colloid product. Sulfur Colloid is indicated to assist in the localisation of lymph nodes draining a primary tumor in patients with breast cancer or malignant melanoma. ]]> <![CDATA[Glenmark to set up a manufacturing plant in US]]> https://biospectrumindia.com/news/95/3394/glenmark-to-set-up-a-manufacturing-plant-in-us.html https://biospectrumindia.com/news/95/3394/glenmark-to-set-up-a-manufacturing-plant-in-us.html Wed, 16 Jul 2014 17:39:22 +0530 Riddled with regulatory hurdles, many Indian pharmaceutical companies are increasingly setting up plants in the US to serve the world's most lucrative market. India's Glenmark Pharma was the latest one to join the bandwagon and has announced that it is planning to set up a greenfield facility to serve the US market, which has sales of generic drugs totaling $65 billion. Before Glenmark, Indian pharma majors like Ranbaxy, Sun Pharma and Wockhardt have all established facilities in the US, in the midst of growing regulatory action by the USFDA over quality issues at their domestic units. Meanwhile, news reports claimed that sources said that Glenmark Pharma will be building a state-of-the-art manufacturing facility estimated to cost $100 million, over a period of four to five years. The report added that it will manufacture oral solids to start with, and injectables and topicals later. This will be the company's first manufacturing facility in North America, adding to its list of 14 plants in four countries - Brazil, Argentina, Czech Republic, and India. ]]> <![CDATA[Diabetes, cardiac drugs will be cheaper by 35 percent]]> https://biospectrumindia.com/news/95/3181/diabetes-cardiac-drugs-will-be-cheaper-by-35-percent.html https://biospectrumindia.com/news/95/3181/diabetes-cardiac-drugs-will-be-cheaper-by-35-percent.html Wed, 16 Jul 2014 15:14:54 +0530 National Pharmaceutical Pricing Authority (NPPA) has fixed the prices of 108 formulation packs of 50 anti-diabetic and cardiovascular medicines, including those which are not listed under the national list of essential medicines (NLEM). Prices of 652 drugs under NLEM were fixed by the government last year under DPCO 2013. This will help in savings for patients prescribed expensive chronic therapies. About Rs 5,500 crore of the pharma market will be impacted, with the range of prices being reduced from 10-15 percent to as high as 35 percent, with the average reduction around 12 percent. The move has surprised the pharma industry. Indian Pharma Alliance's secretary general Mr D G Shah said that the NPPA has gone beyond essentiality as a criterion, and into policy-making, and price fixation, making the NLEM redundant. The regulator says that the new law allows NPPA to fix and revise price caps of drugs in public interest, and this clause applies to both drugs which are part of the NLEM, and those outside of it. Recently, NPPA had decided to monitor prices of all drug brands in critical therapies like cancer, HIV, diabetes, cardiovascular diseases, and tuberculosis. These could also be medicines which are a part of chronic treatments and exorbitantly-priced brands. ]]> <![CDATA[Combination of OPV and IPV best for polio immunization: Study]]> https://biospectrumindia.com/news/95/3952/combination-of-opv-and-ipv-best-for-polio-immunization-study.html https://biospectrumindia.com/news/95/3952/combination-of-opv-and-ipv-best-for-polio-immunization-study.html Mon, 14 Jul 2014 17:23:36 +0530 The study by Imperial College, London, and the Christian Medical College, Vellore, announced on July 11, 2014, has reported that the Injected Polio Vaccine (IPV) which has not been used much in India due to fears of lesser performance, could provide better and longer lasting protection against infection if used in combination with the Oral Polio Vaccine (OPV). The study was conducted on 450 children from a densely populated urban area in Vellore, all of whom had received OPV as part of a standard vaccination program. Half of the children were given a dose of the injected vaccine and rest of the half were given nothing. One month later, the children were given a "challenge" dose of the live oral vaccine to simulate re-infection. Their stools were tested after seven days to see if the virus was present, specifically the two remaining serotypes of the virus which are resisting eradication - serotype 1 and serotype 3. In the children who had received the IPV, the researchers found that less than 38 percent had serotype 1 and lesser than 70 percent had serotype 3 compared to those who had not been given the injected vaccine. According to Dr Jacob John, CMC, "Because IPV is injected into the arm rather than taken orally it's been assumed it doesn't provide much protection in the gut and so would be less effective at preventing faecal transmission than OPV. But we found that where the children already had a level of immunity due to OPV, the injected vaccine actually boosted their gut immunity." "Our findings show that an additional dose of the injected vaccine is more effective at boosting immunity against infection than the oral vaccine alone," said Mr Nick Grassly, professor of vaccine epidemiology at Imperial College London. ]]> <![CDATA[Europe plants â‚¬3.7 billion in bio-based economy]]> https://biospectrumindia.com/news/95/6522/europe-plants-3-7-billion-in-bio-based-economy.html https://biospectrumindia.com/news/95/6522/europe-plants-3-7-billion-in-bio-based-economy.html Mon, 14 Jul 2014 14:02:11 +0530 European Commission president Mr JosÃ© Manuel Barroso, and Commissioner for Research, Innovation and Science, Ms MÃ¡ire Geoghegan-Quinn, announced the formal launch of a â‚¬3.7 billion Public-Private Partnership (PPP) on bio-based industries in Brussels on July 9, 2014.In 2014 and 2015 alone, more than â‚¬250 million is expected to come from the European Commission, with the private sector expected to contribute nearly three times as much. Substantial investments in bio-based products and fuels sourced locally, and made in Europe will be initiated using the continent's untapped biomass and wastes as feedstock, to make fossil-free and greener everyday products. This is seen as an opportunity to create numerous jobs, sparke rural growth, and reduce greenhouse gas emissions. "Europe is not ahead of the curve when it comes to realizing the immense potential around the creation of a bio-based economy, the only viable alternative to our current oil-based society," said Mr Peder Holk Nielsen, president and CEO, Novozymes. "With this unprecedented public-private commitment, however, we demonstrate that EU wants to take the lead in this transition towards a bio-based economy. For Europeans, it is an opportunity to secure thousands of rural jobs and sustainable growth in our regions, while reversing the investment trends currently going to other parts of the world," he shared further. Through financing research and innovation projects, the PPP will create new partnerships between sectors such as agriculture or agro-food, chemicals, energy, pulp and paper, and technology providers. "Advanced biorefineries and innovative technologies will convert the renewable resources into sustainable bio-based chemicals, materials and fuels. The novelty with this PPP is its focus on bridging the gap from R&D to the market," Mr Holk Nielsen added. The large majority of the â‚¬3.7billion will go to first-of-a-kind flagship projects. These are essential to show the technical and commercial viability, at industrial scale, of new generations of bio-based products and fuels, and to reduce perceived investment risks for rolling them out. This partnership represents a shift from a fossil- and imports-based society to increase Europe's share of sustainable economic growth, and is expected to create tens of thousands of jobs, with 80% in rural areas, revitalize industries, and diversify farmers' incomes. The initiative will also help combat climate change, as bio-based products reduce greenhouse gas emissions by at least 50 percent in comparison to fossil-based applications - a number as high as 90 percent in terms of advanced biofuels from agricultural residues and municipal solid waste when compared to oil-based fuels. More than 70 leading European companies in the biotech, chemical, energy, agro-food and pulp and paper sectors are part of the initiative. Concrete examples of projects this PPP intends to support include advanced biorefineries that turn agricultural and forestry residues or municipal solid waste to biochemicals and advanced biofels. According to a press release, by 2020, the ambition is to have at least five flagship biorefineries, each of which is expected to generate feedstock supply chain jobs between 12,000 - 18,000 annually. In 2012, a report by Bloomberg New Energy Finance concluded that in Europe alone more than 1 million jobs can be created from transforming agricultural residues into advanced biofuels, while generating economic growth, reducing greenhouse gas emissions and contributing to energy security by 2030. ]]> <![CDATA[Glenmark receives final ANDA approval for Telmisartan ]]> https://biospectrumindia.com/news/95/5551/glenmark-receives-final-anda-approval-for-telmisartan-.html https://biospectrumindia.com/news/95/5551/glenmark-receives-final-anda-approval-for-telmisartan-.html Mon, 14 Jul 2014 12:22:12 +0530 Telmisartan is indicated for the treatment of hypertension, and the approval has been received for 20mg, 40mg and 80mg tablets. Telmisartan is Glenmark's generic version of Boehringer Ingelheim's Micardis. Glenmark will commence distribution of the product immediately according to the company's statement. For the 12 month period ending March 2014, Telmisartan garnered annual sales of $250 Million according to IMS Health. Glenmark's current portfolio consists of 92 products authorized for distribution in the US marketplace, and 73 ANDA's pending approval with the USFDA. ]]> <![CDATA['Indian employers focus on health and productivity programs is growing' ]]> https://biospectrumindia.com/news/95/7182/indian-employers-focus-on-health-and-productivity-programs-is-growing-.html https://biospectrumindia.com/news/95/7182/indian-employers-focus-on-health-and-productivity-programs-is-growing-.html Sun, 13 Jul 2014 14:15:00 +0530 Indian employers are increasingly focusing on health and productivity programs and is the highest in the Asia Pacific region, which has a direct bearing on the company's financial success, and three in every four employer expect the focus on their initiatives to grow in the next two years. 44 percent of the Indian companies plan to put in place a health and wellbeing strategy within the next couple of years, while 48 percent already have one in place. About 72 percent of Indian employers, believe the focus on such initiatives is likely to grow stronger two years down the line. Internationally, companies with the most effective health programmes are more productive and generate 34 percent higher revenue per employee and such companies enjoy more than 20 percentage points higher market premium. The number of leaves taken by employees of these companies goes down for each employee per year. Employee participation in lifestyle behavior coaching programmes is higher by 20 percentage points for such companies. "These companies are naturally able to build and sustain better well-being over time and achieve even greater benefits in terms of reduced healthcare costs as well as greater productivity and performance," Mr Anuradha Sriram, director benefits, Towers Watson, India said. Around 44 percent of Indian employers claim to offer health risk assessments, more than two in every five (42 percent) of Indian employers in 2013 having instituted work-site diet or exercise activities, almost one in three (32 percent) have instituted stress or resilience management programmes. ]]> <![CDATA[Tamil Nadu recorded second highest dengue cases]]> https://biospectrumindia.com/news/95/3502/tamil-nadu-recorded-second-highest-dengue-cases.html https://biospectrumindia.com/news/95/3502/tamil-nadu-recorded-second-highest-dengue-cases.html Sat, 12 Jul 2014 16:13:00 +0530 Statistics from the National Vector Borne Disease Control Program (NVBDCP) show that the state recorded 677 cases after Maharashtra (963) and was followed by Kerala (651). According to experts, in the state's rural areas, acute water shortage forces people to store water in vessels that help breed mosquitoes. The growing construction activity and piling up of garbage are also behind the spike in dengue cases. "Recent rains caused water stagnation in some areas and resulted in the increase in the numbers of Aedes Aegypti - the mosquito that causes dengue," said a senior official admitting that cases of dengue were unusually high this year. Public health officials, however, said that the figures are not alarming and action has been initiated to remove all possible places where water can stagnate, including discarded tyres, plastic bags and containers. A senior official said that the reporting system in TN was better than in any other state. He said, "We have instructed all hospitals to report every case. Several awareness campaigns have been conducted." In an advisory to all nodal officers across the country, NVBDCP director Mr Anil Dhariwal said, dengue was the fastest emerging infection amongst all vector-borne diseases because of several human and environmental factors. He added, "Last year, we observed circulation of DEN-2 virus in some states which needs to be stopped this year." According to the World Health Organisation, people with dengue fever should rest, drink plenty of fluids and reduce the fever using paracetamol or see a doctor. ]]> <![CDATA[India's BioTech industry reacts to Union Budget 2014]]> https://biospectrumindia.com/news/95/7499/indias-biotech-industry-reacts-to-union-budget-2014.html https://biospectrumindia.com/news/95/7499/indias-biotech-industry-reacts-to-union-budget-2014.html Sat, 12 Jul 2014 14:12:52 +0530 BioTech Industry reacts to the country's Union Budget 2014 ]]> <![CDATA[India's miracle weight loss pill]]> https://biospectrumindia.com/news/95/3119/indias-miracle-weight-loss-pill.html https://biospectrumindia.com/news/95/3119/indias-miracle-weight-loss-pill.html Sat, 12 Jul 2014 12:30:00 +0530 Green coffee bean is fast becoming a popular weight loss treatment as people do not have to do anything different while taking this food supplement. They don't need to exercise or diet. The key component in a green coffee bean is Chlorogenic Acid. It is a very important natural active compound. It works by inhibiting the release of glucose (sugar) into the bloodstream, while at the same time boosting metabolism or the burning of fat in the liver. These two mechanisms combined, work together to inhibit the absorption of fat and cause rapid weight loss. When you roast coffee beans, you remove chlorogenic acid. Green coffee beans are unroasted, have little aroma and are extremely bitter - because they contain over 50 percent chlorogenic acid. ]]> <![CDATA[India the third most obese country in the world: Study]]> https://biospectrumindia.com/news/95/7878/india-the-third-most-obese-country-in-the-world-study.html https://biospectrumindia.com/news/95/7878/india-the-third-most-obese-country-in-the-world-study.html Sat, 12 Jul 2014 10:15:00 +0530 The study titled 'Global, regional, and national prevalence of overweight and obesity in children and adults during 1980-2013: A systematic analysis for "the Global Burden of Disease Study 2013" used data collected by international bodies and organizations in various countries like India over a period of three decades. The US topped the list with 13 percent of obese people worldwide in 2013, while China and India together accounted for 15 percent of the world's obese population. According to the study, the number of overweight and obese people increased from 857 million in 1980 to 2.1 billion in 2013 globally. This is one-third of the world's population. "In the last three decades, not one country has been successful in reducing obesity rates, and we expect it to rise steadily as incomes rise in low developing countries in particular," said Mr Christopher Murray, director of the Institute for Health Metrics and Evaluation (IHME) that conducted the analysis for the study. Mr Pradeep Chowbey, director of the Institute of Minimal Access and Bariatric Surgery at Max Healthcare Institute, said, "If we see the graph of obesity, from 1999 onwards, Indians started gaining weight due to urbanization. There has been gradual economical improvement in our status. The entrance of modern technology and Internet has turned people lazy and stagnant." According to Dr Prabal Roy, senior bariatric surgeon at the Asian Institute of Medical Science, "India is currently witnessing rising numbers for people in the middle-class who are obese. A lot of the Indian population has started relying on processed foods that contain a huge percentage of trans-fat, sugars, and other unhealthy and artificial ingredients. Obesity is considered the core of many diseases. Increased weight carries significant health risks for some cancers, diabetes, heart diseases and strokes," Mr Roy said. ]]> <![CDATA[BioTech & the Budget: HIGHLIGHTS]]> https://biospectrumindia.com/news/95/3512/biotech-the-budget-highlights.html https://biospectrumindia.com/news/95/3512/biotech-the-budget-highlights.html Fri, 11 Jul 2014 20:10:12 +0530 BioTech & India's Union Budget 2014 ]]> <![CDATA[Cipla invests Â£100 million in UK subsidiary]]> https://biospectrumindia.com/news/95/5957/cipla-invests-100-million-in-uk-subsidiary.html https://biospectrumindia.com/news/95/5957/cipla-invests-100-million-in-uk-subsidiary.html Fri, 11 Jul 2014 16:46:00 +0530 Said The Right Honourable George Osborne, Chancellor of the Exchequer, Her Majesty's Government of the United Kingdom, "I am happy to be able to announce that Indian pharmaceutical company Cipla will invest up to £100 million in the UK. The investment will fund the launch of a range of drugs in the areas of respiratory, oncology and anti-retroviral medicines as well as R&D, clinical trials and further expansion internationally and in the UK." On the occasion of the 66th anniversary of the British National Health Service (NHS), Cipla believes that by providing high quality affordable medicines for patients, it can contribute cost effective solutions for the NHS. "We are very pleased to be making this investment in the UK. We were impressed with the pro-active support and engagement that the UK Government and its various ministries showed in attracting Cipla to choose the UK as a key hub in our global footprint," said Mr Rajesh Garg, global chief financial officer and member of the board of Cipla. ]]> <![CDATA[ABLE finds budget in line with market expectations ]]> https://biospectrumindia.com/news/95/3308/able-finds-budget-in-line-with-market-expectations-.html https://biospectrumindia.com/news/95/3308/able-finds-budget-in-line-with-market-expectations-.html Fri, 11 Jul 2014 16:36:04 +0530 Although it was expecting much more clarity on GST, the Association of Biotechnology Led Enterprises (ABLE) is still upbeat about the announcements made in the union budget 2014. In his budget reaction, Dr P M Murali, president, ABLE mentioned, "Overall, the budget seems to have delivered in line with market expectations, with adequate focus on infrastructure and measures to boost financial savings. Though, more clarity on the roadmap to GST would have been welcome. ABLE welcomes the focus on strengthening of institutions as Technical Research Centers as this will strengthen the skill gaps and boost productivity. "The emphasis given to startups, entrepreneurship, innovation and incubation is also a welcome initiative to boost technology and product innovation. It is also heartening to see the focus on the agriculture and biotechnology sector. The scaling up of agri-biotech clusters will help enhance competitiveness and innovation capacity," added Dr Murali. In its pre-budget expectations, the leading association had urged the government to consider an overhaul of the Pharma-Biotech sector as it is the need of the hour. "Perception and credibility of this sector have been completely eroded due to several factors in the past few years," ABLE had said in a statement before the finance minister's speech. ]]> <![CDATA[Bioagri experts welcome budget allocations for technology, capacity building]]> https://biospectrumindia.com/news/95/5623/bioagri-experts-welcome-budget-allocations-for-technology-capacity-building.html https://biospectrumindia.com/news/95/5623/bioagri-experts-welcome-budget-allocations-for-technology-capacity-building.html Fri, 11 Jul 2014 16:20:00 +0530 Making his comments on the budget announcements, Mr Ajay Kakra, associate director, Agri and Natural Resources, PwC India, mentioned, "The budget has touched upon some critical areas such as agri-infrastructure, capacity development, farm lending etc. which are essential for agricultural development. Allocation for warehousing capacity development are in the right direction, however, there is a long way to go before the infrastructure gap is met in the agricultural sector. Tax Exemption for cotton ginning mills will be helpful to the Indian cotton industry." According to Dr K C Ravi, head, Corporate Affairs, Syngenta India, the commitment of the government to achieve a sustainable growth of 4 percent through technology driven second green revolution in agriculture is welcome. The NDA government has also recognized the need to step up public and private sector investments in agro technology development through creation and modernization of exiting agri-business infrastructure. "The move towards integrating markets for farmers across the country is a novel idea and should get support of the state governments and made possible by integration of technologies. Another welcome step is the proposal to link MGNREGA to be more productive, for asset creation and with linkages to agriculture and allied activities and is a step in the right direction. The proposal to develop global partnerships under India's leadership, to transform the Delhi component of the International Center for Genetic Engineering and Biotechnology (ICGEB) into a world-leader in lifesciences and biotechnology is a welcome step and we do hope that agriculture biotechnology will also get the desired focus, added Dr Ravi. ]]> <![CDATA[Govt intends to eradicate Kala Azar within a year]]> https://biospectrumindia.com/news/95/5605/govt-intends-to-eradicate-kala-azar-within-a-year.html https://biospectrumindia.com/news/95/5605/govt-intends-to-eradicate-kala-azar-within-a-year.html Fri, 11 Jul 2014 15:06:20 +0530 Dr Harsh Vardhan, union health minister, has formed a core group to plan a detailed course of action to eradicate the dreaded vector-borne disease Kala Azar by 2015. In 2004, the government had set a target of wiping out the disease by 2008. It was then revised twice, once to 2010 and eventually 2015. With less than a year to go, the newly installed Health Minister reviewed the resources at his disposal and expressed confidence in achieving the objective. Kala Azar is globally known as Visceral Leishmaniasis, a zoonotic infection whose carrier is the sand fly found in eastern UP, Bihar, Jharkhand and West Bengal. It usually strikes during the monsoon months. It is the second deadliest vector borne disease after malaria. Presently, its incidence is concentrated to about 54 districts, with Bihar the most affected. Ninety percent of visceral leishmaniasis cases occur in 5 countries: Bangladesh, India, Nepal, Sudan and Brazil. The minister has named Dr Ranjit Roy Chaudhury, a leading clinical pharmacologist who headed WHO's Rational Use of Drugs in India program, to coordinate a group of experts and officials which includes former Health Minister, Dr C P Thakur, head of Indian Council of Medical Research; Dr V M Katoch, director general of health services (DGHS); Dr Jagdish Prasad, a specialist in pharmaceuticals; Mrs Kavita Khanna, the head of the National Vector Borne Disease Control Program; Dr A C Dhariwal, the health secretaries of Bihar, West Bengal, Jharkhand and Uttar Pradesh, and joint secretary in the union health ministry, Mr Anshu Prakash. As Kala Azar strikes mainly during the monsoon months, the Minister said there is precious little time to lose. Therefore, he intends to launch the first free treatment drive in selected pockets of Bihar and other states in August. The first meeting of the core group will be held later this week to draw up a plan of action. "One of the first tasks before the committee would be to select appropriate medication for the treatment of victims because the drug policy on Kala Azar has been under review for a number of years. I have advised the core group to expedite the process because unless we strike fast, a great many lives would be lost," Dr Harsh Vardhan said. In the 1920s, the late Dr U N Brahmachari's research led to the use of Sodium Stibogluconate as a breakthrough in treatment lines, the Health Minister stated. However, today's patients have developed resistance to this drug. Now three other drugs are being used but without much empirical evidence on their success. One of them, which is usually used for chemotherapy of breast cancer patients, has serious side-effects, he added. Mission mode Dr Harsh Vardhan said the country's progress against Kala Azar had been unsatisfactory. At the present rate, eradication of the disease by 2015 looks uncertain because the health infrastructure in the affected states is quite inadequate, he noted. "I am however confident of the positive values in people from all walks of life. If people could lend a hand and eradicate polio, then kala azar is child's play. I am confident of receiving full cooperation from people in all walks of life," Dr Harsh Vardhan said. While on tour in the United States recently, he had been requested by Dr Tom Frieden, director of the Centre for Disease Control, Atlanta, not to dismantle the excellent social mobilisation and surveillance networks built up for pulse polio and to make use of the men and material from that program for drives against measles and other deadly communicable diseases. "There is no question of forgetting the lessons of Pulse Polio. We will not fritter away the gains in terms of the social mobilisation so that health for all becomes a mass movement", Dr Harsh Vardhan added. ]]> <![CDATA[Budget boost for biotech research, entrepreneurship ]]> https://biospectrumindia.com/news/95/1141/budget-boost-for-biotech-research-entrepreneurship-.html https://biospectrumindia.com/news/95/1141/budget-boost-for-biotech-research-entrepreneurship-.html Thu, 10 Jul 2014 17:28:20 +0530 With a thrust on technology development through public private partnerships, the union budget 2014 offers big encouragement to the small enterprises, biopharma and agriculture research as well as a few initiatives to increase access to healthcare. New entreprenuers means big industry in future Making this announcement while presenting the General Budget in Lok Sabha, union finance minister, Mr Arun Jaitley stated that the promotion of entrepreneurship and start-up companies remains a challenge. In order to create a conducive ecosystem for venture capital in the MSME, he proposed to establish a Rs 10,000 crore fund to act as a catalyst to attract private capital by way of providing equity, quasi equity, soft loans and other risk capital for start-up companies. The Minister also announced the establishment of a Technology Centre Network to promote innovation, entrepreneurship and agro-industry. He proposed setting up a corpus fund of Rs 200 crore. The Finance Minister has announced the development of an entrepreneur friendly legal bankruptcy framework for SMEs to enable easy exit. He said that a nationwide "District level Incubation and Accelerator Program" would be taken up for incubation of new ideas and providing necessary support for accelerating entrepreneurship. Big boost for biotech research The Department of Science and Technology has some of country's leading research centers in areas such as nanotechnology, materials science, and bio- medical device technology. The government will strengthen at least five such institutions as Technical Research Centers to make them more effective in the innovation space through Public Private Partnerships. The government intends to stimulate biotechnology research through investments and partnerships. Working in that direction, the development of biotech clusters in Faridabad and Bengaluru will be scaled up and taken to the highest international quality. This effort will include global partnerships in accessing model-organism resources for disease biology, stem cell biology and for high-end electron microscopy.The nascent agri-biotech cluster in Mohali will be scaled up to include plant-genetic and phenotype platforms. Secondary agriculture will be a major thrust in Mohali through collaborations in the public and private sector. In addition, two new clusters, in Pune and Kolkata will be established. Global partnerships will be developed under India's leadership to transform the Delhi component of the International Center for Genetic Engineering and Biotechnology (ICGEB) into a world-leader in lifesciences and biotechnology. Health for all As per the Economic Survey for 2013-14 tabled in the Parliament, a mere 1.4 percent of GDP is spent on healthcare. To move towards "Health for All", the two key initiatives i.e the Free Drug Service and Free Diagnosis Service would be taken up on priority. With an aim to make healthcare assessable to poorer and rural sections of society, five new AIIMS like institutions have been proposed in Andhra Pradesh, West Bengal, Vidharbha in Maharashtra and Poorvanchal in UP. For the first time, the Central Government will provide central assistance to strengthen the States' drug regulatory and food regulatory systems by creating new drug testing laboratories and strengthening the 31 existing state laboratories. Protein revolution all the way The finance minister while presenting his maiden budget said that the Government is committed to sustain a growth of 4 percent in agriculture. He said that for this, the government will bring technology driven second Green Revolution with a focus on higher productivity and include "Protein revolution" as an area of major focus. Finance minister also proposed to set aside a sum of Rs 50 crore for the development of indigenous cattle breeds and an equal amount for starting a blue revolution in inland fisheries. To give a boost to agriculture, two institutions on the pattern of Indian Agricultural Research Institute, Pusa, will be established in Assam and Jharkhand with an initial sum of Rs 100 crore in the current financial year. Agricultural universities are proposed to be set up in Andhra Pradesh and Rajasthan, besides two horticulture universities in Telangana and Haryana. Higher education is also on government's radar as it intends to set up five more IITs in the Jammu, Chattisgarh, Goa, Andhra Pradesh and Kerala. This is expected top benefit bioscience education too in the longer run. Takeaways:â– Tax incentives to spur investment in research and development â– Simpler tax norms, including rapid implementation of GSTâ– Increase tax exemption for setting up hospitalsâ– Infrastructure status along with tax benefitsâ– Double health care expenditure to 8 percent in the next 5 yearsâ– Major boost to R&D. ]]> <![CDATA[June recorded maximum malaria, dengue cases]]> https://biospectrumindia.com/news/95/6690/june-recorded-maximum-malaria-dengue-cases.html https://biospectrumindia.com/news/95/6690/june-recorded-maximum-malaria-dengue-cases.html Thu, 10 Jul 2014 15:09:46 +0530 "A total of 32,812 suspected malaria cases were detected in the city in the past six months. Out of these, 20 patients were confirmed to have malaria. There were as many as 296 suspected dengue patients in the same period, of which 37 were confirmed to have contracted the virus," said Mr Anil Roy, medical officer of health(MOH), Pimpri Chinchwad Municipal Corporation (PCMC). Eight malaria cases were registered in June, while just one patient was found to have malaria in January. The month of June also recorded 23 dengue cases, while one case was confirmed in April. From June 9-29, the civic health department as part of a drive to find and destroy mosquito breeding places in the municipal limits, searched a total of 21,587 houses. The department went through 62,890 containers and found mosquito larvae in 286 houses. Dengue and Chikungunya are both caused by the mosquito Aedes egyptii. The female mosquitoes lay eggs in stagnant water, so there is a need to empty and clean water storing utensils regularly. Some of the precautions that need to be taken are :Overhead and underground tanks that cannot be emptied must be closed with tight lids to prevent the mosquitoes from entering and laying eggs. Water in the flower pots and trays below refrigerators must also be emptied every week. Care must be taken to dispose of scrap material stored in courtyards or terraces of houses to avoid accumulation of water, which could act as breeding grounds for mosquitoes. ]]> <![CDATA[Demand for nutraceutial ingredients to touch $30 bn by 2017]]> https://biospectrumindia.com/news/95/3524/demand-for-nutraceutial-ingredients-to-touch-30-bn-by-2017.html https://biospectrumindia.com/news/95/3524/demand-for-nutraceutial-ingredients-to-touch-30-bn-by-2017.html Tue, 08 Jul 2014 17:59:12 +0530 The global demand for nutraceutical ingredients is forecast to rise 7.2 percent annually to $30 billion in 2017, serving end product markets totaling $369 billion, according to a report released by Reportlinker. The best growth prospects will exist in substances with clinically supported health benefits and broad applications in foods, beverages, dietary supplements,and adult and pediatric nutritional preparations.Included in this group are soy proteins; oat bran, psyllium, and soy fibers; Bifidobacterium and Lactobacillus probiotics; omega fatty acids; cranberry and garlic extracts; calcium, magnesium, and zinc minerals; and vitamins A and C.Emerging market to witness fastest growth Countries such as Brazil, China, India, Mexico and Turkey will be among the fastest growing consumers and producers of nutraceutical ingredients worldwide. Increasing economic prosperity will enable these countries to expand and diversify their food and beverage, processing, and pharmaceutical industries. In 2017 China, alone, will absorb more than 16 percent of the value of global nutraceutical ingredient demand and will account for over 18 percent of the value of related world shipments. Because of maturing markets, the supply and demand of nutraceutical ingredients in the United States, Western Europe, and other developed economies will increase more slowly than the average worldwide pace. Nonetheless, food, beverage, and pharmaceutical companies in these economies will continue to pursue opportunities in conventional and specialty nutritional products and natural medicines. As a result, they will remain key customers for nutraceutical ingredients.Nutrients to remain top-selling ingredients Nutrients, including proteins, fibers, and various specialised functional additives, will remain the top-selling group of nutraceutical ingredients worldwide. Proteins will post the fastest demand gains as food and beverage makers throughout the world introduce new high value-added nutritional preparations. Functional additives and fiber nutrients will also fare well in the global marketplace. Demand for these ingredients will gain upward momentum from increasing clinical evidence of health benefits and expanding applications in specialty foods and beverages.Herbal and other extracts to be fastest growing products Naturally derived substances, consisting of herbal and botanical extracts, and animal and marine-based derivatives, will command the fastest growth among the three major groups of nutraceutical ingredients. Among these substances, omega fatty acids derived from fish oils and other marine sources will lead gains, reflecting clinically proven cardiovascular benefits and expanding use in dietary supplements and nutritional therapies. The rising popularity of homeopathic remedies, coupled with widespread trends promoting preventive medicine and self treatment, will impact favorably on global demand for numerous other natural extracts and derivatives, including cranberry, garlic, ginkgo biloba, ginseng; and glucosamine and chondroitin. Well established applications in food and beverage fortification; infant, adult, and pediatric nutritionals; and dietary supplements will continue to underlie a large global market for mineral and vitamin ingredients. Within this group, essential minerals such as calcium, along with vitamins A and C substances, will post the fastest gains in world demand. ]]> <![CDATA[Agriculture ministry lauds research work at IARI, NBPGR ]]> https://biospectrumindia.com/news/95/3522/agriculture-ministry-lauds-research-work-at-iari-nbpgr-.html https://biospectrumindia.com/news/95/3522/agriculture-ministry-lauds-research-work-at-iari-nbpgr-.html Tue, 08 Jul 2014 17:36:59 +0530 Mr Radha Mohan Singh, union minister of agriculture, and Dr Sanjeev Kumar Balyan, minister of state for agriculture visited the National Gene Bank of NBPGR and appreciated the efforts for conservation of biodiversity for posterity. During a visit to Nuclear Research Laboratory (NRL) and Experimental Farms, IARI dignitaries expressed satisfaction over the recent advances in the field. They were impressed by the innovative exhibits of the National Agricultural Science Museum (NASM) situated in the campus of National Agricultural Science Centre (NASC). While visiting the library of IARI, Mr Singh and Dr Balyan also had an interaction with scientists of IARI. Dr H S Gupta, director, IARI made presentation on the contributions of IARI for Indian Agriculture on the occasion. Mr Singh took keen interest and appreciated the initiatives proposed by IARI. Earlier, Dr Ravinder Kaur, project director, WTC informed that the plant will treat sewage water from the residential colony of IARI without using any chemicals. It has the capacity to process 2.2 million litres of waste water per day. The treated water will be used to irrigate farms in the campus. The water treatment plant is an innovative initiative of IARI that has been set up in four acres with the aim to enhance water availability at IARI farm research fields. The Chairman, ASRB; Deputy Directors General of ICAR; and senior scientists and officials of ICAR/IARI were also present on the occasion. (Source: Directorate of Knowledge Management in Agriculture, ICAR) ]]> <![CDATA[Punjab approves high yielding maize varieties]]> https://biospectrumindia.com/news/95/8490/punjab-approves-high-yielding-maize-varieties.html https://biospectrumindia.com/news/95/8490/punjab-approves-high-yielding-maize-varieties.html Mon, 07 Jul 2014 15:16:57 +0530 The Punjab Chief Minister Parkash Singh Badal recently approved a proposal from the State agriculture department, which shortlisted Monsanto and two other companies to provide high yielding varieties (HYV) of maize seeds to farmers at subsidised rates during the current Kharif season. As per the state government, after thorough research and a detailed exercise in collaboration with the Punjab Agriculture University (PAU), it has agreed to subsidise the seeds of these companies, which had reported yields of 8.5 tonnes per hectare during the trials. To ensure their easy availability, the State government has also decided to make these HYV seeds available at all the block level offices of the Agriculture department. The government has also directed the three shortlisted companies to provide all relevant technical support to the farmers for sowing the seeds for their better results. HYV maize was identified as a major alternative crop under the crop diversification program of the State government, which proposes to replace about five lakh acres under water guzzling paddy cultivation that began in second week of June. ]]> <![CDATA[India's Orchid Pharma completes debt recast]]> https://biospectrumindia.com/news/95/3992/indias-orchid-pharma-completes-debt-recast.html https://biospectrumindia.com/news/95/3992/indias-orchid-pharma-completes-debt-recast.html Mon, 07 Jul 2014 12:25:45 +0530 An Indian company, based in Chennai, Orchid Chemicals and Pharmaceuticals has said that it has completed the debt recast scheme that it had initiated last year. As per the process, Orchid will pay back dues of â‚¹2,866 crore to a consortium of lenders over a period of 10 years. Further, the Business Transfer Agreement that Orchid entered into with Hospira India in 2012 too has been cleared by the RBI panel on debt recast. This agreement allows the company to pay-off a portion of its total debt of â‚¹3,547 crore and meet working capital requirements. A news report pointed out that the proceeds of the sale to Hospira amount to â‚¹1,134 crore. In a statement to BSE, the company's managing director, Mr K Raghavendra Rao said, "With this development, the company is back on the growth path. With our inherent strength in the cephalosporins segment, our rebuilding process will be fast and robust." Meanwhile, the company is said to be battling a case of mismanagement of affairs filed by Mr Cyrus Poonawalla-backed Serum Institute of India. Mr Poonawalla and associated firms, which hold 14.19 percent in Orchid, had asked for an interim stay on the debt recast process, but it was not granted. The Company Law Board is expected to deliver the final verdict on July 22. ]]> <![CDATA[NeuClone, Serum Institute join hands]]> https://biospectrumindia.com/news/95/1478/neuclone-serum-institute-join-hands.html https://biospectrumindia.com/news/95/1478/neuclone-serum-institute-join-hands.html Mon, 07 Jul 2014 12:24:28 +0530 Sydney-based biotechnology firm, NeuClone has signed a major licensing agreement and joint development partnership with The Serum Institute of India. The deal will cover the manufacture of 10 biosimilar drugs. As per the agreement, NeuClone will use its NeuMAX cell line development platform to manufacture and supply ten biosimilar monoclonal antibody drugs. One of the world's largest vaccine producer, The Serum Institute, will provide its biologics manufacturing capability. The companies explained that the drugs will target cancer and autoimmune disorders, and each will address markets worth hundreds of millions to billions of dollars. As part of the partnership, NeuClone will retain the licence to the biosimilars for the markets of the US, Europe, Canada, Australia, Taiwan, Japan and South Korea. ]]> <![CDATA[Top 20: INDIA - Marginal growth ]]> https://biospectrumindia.com/features/95/3844/top-20-india-marginal-growth-.html https://biospectrumindia.com/features/95/3844/top-20-india-marginal-growth-.html Fri, 04 Jul 2014 16:26:41 +0530 Country Analysis for the APAC region show that India's bioscience success story received a jolt in 2013 due to regulatory and pricing issues. The sector grew only by 3 percent. Interestingly, India too had eight companies that crossed the $1 billion mark. In fact, India's two leading companies Sun Pharma and Dr Reddy's have touched the $2 billion mark for the first time. India announced its plan to elevate its pharma industry to touch $100 billion by 2020. USFDA deputed training personnel to Indian state, Gujarat, to enhance quality standards of drugs exported from the state. GE Healthcare and Cancer Treatment Services International (CTSI) plans to invest $120 million in the country to develop 25 world-class centers across the country to improve cancer care over a period of 5 years. INDIA: TOP 20 BIOSCIENCE COMPANIES ]]> <![CDATA[Glenmark's MAb drug enters human trials]]> https://biospectrumindia.com/news/95/3840/glenmarks-mab-drug-enters-human-trials.html https://biospectrumindia.com/news/95/3840/glenmarks-mab-drug-enters-human-trials.html Fri, 04 Jul 2014 15:56:35 +0530 Bangalore: Glenmark Pharmaceuticals, a research-driven, global integrated pharmaceutical company announced that its novel monoclonal antibody (MAb), GR 830 has successfully completed the phase I testing and was now under human trials. GBR 830 is an antagonistic monoclonal antibody, with a potential to treat autoimmune diseases by targeting T cells. With this, Glenmark now has three monoclonal antibodies in clinical development. The antibody targets OX40, a co-stimulatory receptor on auto reactive T cells. The pharma giant said that this experimental antibody candidate showed increased efficiency in affecting T cell proliferation, and exhibited a good safety profile. The drug could potentially treat many autoimmune disorders like as rheumatoid arthritis, multiple sclerosis, inflammatory bowel disease and lupus. GBR 830 does not exhibit agonism that increases the safety profile of the drug, preventing any side effects. Dr Michael Buschle, president of Biologics and chief scientific officer, Glenmark said that GBR 830 was a very difficult program and the progress made by scientists was truly commendable. ]]> <![CDATA[Quest diagnostics gets awarded by IMA ]]> https://biospectrumindia.com/news/95/3833/quest-diagnostics-gets-awarded-by-ima-.html https://biospectrumindia.com/news/95/3833/quest-diagnostics-gets-awarded-by-ima-.html Fri, 04 Jul 2014 15:08:59 +0530 This award by Indian Medical Association (IMA) as per company is recognition of the various technological innovations that Quest Diagnostics India has implemented to minimize pre analytical and process errors to enhance accuracy of testing & provide better diagnostic insights to all its patients. Innovative diagnostic tests and systems play a pivotal role in the groundbreaking area of integrated healthcare solutions. Additionally, research plays a vital role when it comes to early detection, targeted screening, evaluating and monitoring diseases, making R&D one of the most critical aspects of the diagnostics industry. Sharing his thoughts at this special occasion, Mr Mukul Bagga, managing director, Quest Diagnostics India said, "This award is yet another valuable acknowledgement of our constant endeavor to instill new technological and innovative capabilities to deliver enhanced diagnostics insights to all our patients. Being awarded by the Indian Medical Association is extremely gratifying. Quest has always been a forerunner in promoting and stimulating innovative research on a continuous basis. At Quest we have one of the most sophisticated Laboratory Information Management Systems and are particularly proud of being one of the pioneers in the field of digital pathology to benefit cancer patients. These coupled with our patient & physician portal Quest4Health.com empowers us to deliver high quality healthcare outcomes via optimum use of our research and innovation capabilities." Some technology innovations, introduced by Quest Diagnostics India in the recent past. The Laboratory Information Management system (LIMS) automates reporting from sample loading to the final report, a crucial cog in the delivery mechanism. Quest Diagnostic in India currently has the most sophisticated LIMS-NeTLIMS available in the industry. Quest Diagnostics India has also been one of the pioneers in the field of digital pathology to benefit cancer patients through a second opinion service. An advanced digital pathology platform is used to exchange medical information and seek the expert opinion from among a panel of 600 organ-focused Quest experts based in the United States. Data reported at the recently held Indian Cancer Congress - a retrospective review of 500 cancer cases that were referred for an expert opinion revealed that 40 percent had their original treatment protocols changed after review of those cases by the panel of Quest experts. Quest also has a patient and Physician access portal - Quest4Health.com through which tests can be ordered and reports can be accessed including historical data / reports. The patient data is retained on the site for 10 years. This portal is easily accessible on smart phones as well - empowering patients with their diagnostic insights at their finger tips Additionally, awareness about preventive health checkups has increased exponentially. To meet these renewed awareness levels, Quest provides a personal wellness package called the "Blueprint for Wellness". Various globally published epidemiology studies on health risk factors have been used to create a proprietary algorithm. Data from a panel of specified tests is entered into this algorithm to generate this personal wellness report. This personal wellness report provides a quantified organ wise health risk assessment. The report is a unique offering of Quest Diagnostics not offered by any Diagnostic service provider in the country. Furthermore a unique initiative launched by Quest involves registering the patient on the Quest4health portal directly .If it's a home collection - the customer care team collects demographic information and uploads it to the Quest4health site. The phlebotomist assigned to visit the patients for home collection carries a smart phone on which he is able to view and reconfirm the patient demographics and test requirement. A blue tooth printer is also provided to provide a receipt for the transaction. This saves the patient the time of filling out the form, also scope for errors in transferring the data from the requisition form to the system at the lab during process is reduced. This enhances patient convenience and reduces the errors in the processing phase. All these innovative IT systems and services are backed with a very high level of security covered under HIPAA; all the patient information transmitted using HL7 protocol. Quest Diagnostics India operates a state-of-the-art 65,000 square feet laboratory in Gurgaon and has logistics and collection capabilities in 25 cities, including Delhi, Mumbai, Bangalore, Kolkata, Hyderabad, Ahmadabad, Kochi and others. ]]> <![CDATA[Budget 2014: Pharma reforms highly required says Venus CMD]]> https://biospectrumindia.com/news/95/3838/budget-2014-pharma-reforms-highly-required-says-venus-cmd.html https://biospectrumindia.com/news/95/3838/budget-2014-pharma-reforms-highly-required-says-venus-cmd.html Fri, 04 Jul 2014 15:08:27 +0530 The change in central government has raised the expectations of the pharmaceutical industry. With the NDA government all set to table its first budget in Parliament on July 10, the pharma industry is ready with its wish list, suggesting a slew of measures to give a push to this crucial sector of the economy. According to Mr Pawan Chaudhary, chairman and managing director (CMD), Venus Remedies, reforms are like a key that can unlock the potential of the sector. About his wishlist, he said,"Essentially speaking, we expect this budget to push for a new era of accelerated reforms. We hope that the budget supports the industry by giving incentives to exporters like exemption under section 80HHC. The government should also give impetus to R&D through incentive-linked funding. We also expect more clarity on guidelines for expenditure liable on weighted average deduction under section 35(2) AB of the Income Tax Act. All the expenditure incurred on R&D, whether in-house or outsourced, in India or overseas, should be liable for tax deduction." Talking about intellectual property, Mr Chaudhury elaborates on his expectations, "IPR taxation is another area where India is yet to take any initiative. Many European countries have a 'Patent Box' scheme to provide special tax rebates on income from patents. It is high time India took a decisive stand on such issues." "The inverted structure of excise duty in the pharmaceutical industry also needs rectification. Meant to be temporary tools of taxation, surcharge and education cess should be done away with and replaced by a more rational tax structure based on a wider tax base. Furthermore, Minimum Alternate Tax (MAT) rates should be brought down as they are very high and impact cash flows of companies. Since most of the pharmaceutical companies have their subsidiaries or arms overseas and are subject to international taxes, safe harbour rules should be extended to cover sales of pharmaceutical products," Mr Chahudhary said. Venus Remedies reaches out to all significant markets across the globe with presence in 5 continents and 60 countries. We have received patents for our research products from established markets such as Europe, USA, Japan, Canada, South Africa, Australia and so on, wherein the company is soon going the launch its respective product line in Oncology and AMR segment to mark its presence there as well. The company is currently working on a robust pipeline of 25 products, in various stages of development, including the 12 novel products that have already been commercialised. ]]> <![CDATA[India gets its vaccine boost, Four new vaccines included in UIP]]> https://biospectrumindia.com/news/95/7047/india-gets-its-vaccine-boost-four-new-vaccines-included-in-uip.html https://biospectrumindia.com/news/95/7047/india-gets-its-vaccine-boost-four-new-vaccines-included-in-uip.html Fri, 04 Jul 2014 14:53:28 +0530 The Prime Minister of India, Mr Narendra Modi on July 03,, 2014 announced the decision of the government of India to introduce four new vaccines as part of India's Universal Immunization Programme (UIP). Vaccines against rotavirus, rubella and polio (injectable) will collectively expedite India's progress on meeting the Millennium Development Goal 4 targets to reduce child mortality by two-thirds by the year 2015 and meet global polio eradication targets. In addition, an adult vaccine against Japanese encephalitis will be introduced in districts with high levels of the disease. Along with the recent introduction of a pentavalent vaccine, this decision represents one of the most significant policy leaps in 30 years in public health, preventing at least 1 lakh infant deaths, death of adults in working age group and up to 10 lakh hospitalizations each year. With these new vaccines, India's UIP will now provide free vaccines against 13 life threatening diseases to 27 million children annually, the largest birth cohort in the world. The Prime Minister said "The introduction of four new lifesaving vaccines will play a key role in reducing childhood and infant mortality, and morbidity in the country. Many of these vaccines are already available through private practitioners to those who can afford them. The government will now ensure that the benefits of vaccination reaches all sections of the society, regardless of social and economic status." Diarrhea caused by rotavirus kills nearly 80 thousand children each year, results in up to 10 lakh hospitalizations, pushing many Indian families below the poverty line. It also imposes an economic burden of over Rs 300 crore each year on the country. India has developed and licensed its first indigenous rotavirus vaccine, developed under a public-private partnership by the Ministry of Science and the Ministry of Health and Family Welfare. India will introduce this vaccine in a phased manner.Tackling another major public health concern, the Government of India's Universal Immunization Program is set to introduce a vaccine against rubella which causes severe congenital defects in newborns like blindness, deafness and heart defects. It is estimated that nearly 2 lakh babies are born with congenital defects each year in the country. The Universal Immunization Program is also introducing an adult vaccine against Japanese Encephalitis (JE) in 179 endemic districts in 9 states. Reaffirming its commitment to the global goal of a polio free world, India is set to introduce an Injectable Polio Vaccine (IPV), together with 125 countries in a globally synchronized manner. India has been certified polio free in March 2014, and the introduction of IPV in addition to the oral polio vaccine (OPV) will provide long lasting protection to the population against the virus. Shri Narendra Modi, who has consistently placed an emphasis on health as part of the nation's development, said "India is committed to tackle child mortality and provide health for all through multiple initiatives taken up by the government. Strengthening routine immunization is an essential investment in India's children and will ensure a healthy future of the country." The recommendations to introduce new vaccines have been made after numerous scientific studies and comprehensive deliberations by the National Technical Advisory Group of India (NTAGI), the country's apex scientific advisory body on immunization. ]]> <![CDATA[A policy to check API imports from China needed: IPA]]> https://biospectrumindia.com/news/95/3834/a-policy-to-check-api-imports-from-china-needed-ipa.html https://biospectrumindia.com/news/95/3834/a-policy-to-check-api-imports-from-china-needed-ipa.html Fri, 04 Jul 2014 12:30:15 +0530 The India Pharmaceuticals Association (IPA) has urged the Finance Ministry to come up with a policy framework to incentivize drug innovation, and ease dependence on the import of essential Active Pharma Ingredients (APIs) from China. India is dependent on China for some of the APIs and this may become a serious concern, if problems arise in the supply chain system, informed IPA President Mr K Satish Reddy. "If there is breakdown in the supply chain for any reason for the ingredients coming from China, we will suffer because India does not have the capacity to meet that kind of demand and it will lead to higher costs," he explained. The association also suggested that the government concentrate on setting up industrial clusters to manufacture some of the essential drugs in bulk. Further, it has also requested an increase in the weighted deduction on R&D expenses from 200 percent to 250 percent in the upcoming union Budget. "If we would like to spur innovation in this country, we expect a policy framework which would incentivize innovation," said Mr Reddy, chairman, Dr Reddy's Laboratories. He also believes that the current system is not favorable for incubating innovative ideas. He stressed that the linking of incubation centers with universities should be encouraged. ]]> <![CDATA[Philips, salesforce.com tie up to enhance telehealth ]]> https://biospectrumindia.com/news/95/4482/philips-salesforce-com-tie-up-to-enhance-telehealth-.html https://biospectrumindia.com/news/95/4482/philips-salesforce-com-tie-up-to-enhance-telehealth-.html Thu, 03 Jul 2014 18:02:52 +0530 In a bid to bring better solutions to the healthcare delivery platform, medical technology company, Royal Philips and salesforce.com have partnered to deliver an open, cloud-based healthcare platform to enhance patient relationship management and to enable medical device and data interoperability. The idea, according to the company, is to enhance the collection of data and subsequent analysis to enhance clinical decision making with solutions such as Philips eCareCoordinator and Philips eCareCompanion. These care collaboration applications would monitor patients with chronic conditions in their homes and facilitate Philips' Hospital to Home clinical programs. "With this strategic alliance, Philips is making great strides to deliver real-time, digital healthcare solutions," said Mr Frans van Houten, chief executive officer, Royal Philips. "Healthcare data exists in many different forms and in many different systems today. Together with salesforce.com, we have a tremendous opportunity to reshape and optimise the way healthcare is delivered and provide better access to data across the continuum of care," he added. "We have entered a new transformative era for healthcare, and technology is enabling the industry to connect to, care for and engage with patients and each other in a profound new way," said Mr Marc Benioff, chairman and ceo, salesforce.com. "Together with Philips, we are creating an open health platform and ecosystem to benefit everyone that cares about one of the most important issues of our time," he said. ]]> <![CDATA[BIRAC invites research proposals ]]> https://biospectrumindia.com/news/95/3453/birac-invites-research-proposals-.html https://biospectrumindia.com/news/95/3453/birac-invites-research-proposals-.html Thu, 03 Jul 2014 14:56:14 +0530 The Biotechnology Industry Research Assistance Council (BIRAC) has invited research proposals from entrepreneurs or potential entrepreneurs from academia, research institute, or researchers, PhDs, medical degree holders and biomedical engineering graduates who have an exciting idea, which may be in the nascent planning stage and there is a need for mentorship, and initial funding. The scheme, which is implemented under the Department of Biotechnology (DBT)'s Biotechnology Ignition Grant (BIG) scheme, aims to promote high level of innovation in the biotechnology sector, and will support and nurture high risk early starters and their concepts. Funding will be in the form of grant-in-aid limited up to Rs 50 lakh and it may also be used for conducting limited market research, patenting costs, working capital during the period, travel, salary etc. The period for the study would not exceed 18 months. Biotechnology start-ups which are registered companies, incorporated on or after July 1, 2011 with a functional R&D laboratory can apply under this scheme. If the registered company does not have a functional laboratory of its own, then it should be incubated in an incubator which has a functional laboratory. This is the fifth call for proposals from BIRAC since the BIG scheme was launched in 2012 for igniting new ideas in biotechnology. The last date for submission of proposals is August 16, 2014. ]]> <![CDATA[Proactive measures on to contain Dengue, Malaria]]> https://biospectrumindia.com/news/95/4170/proactive-measures-on-to-contain-dengue-malaria.html https://biospectrumindia.com/news/95/4170/proactive-measures-on-to-contain-dengue-malaria.html Thu, 03 Jul 2014 14:53:00 +0530 At a meeting held on July 02, 2014 to review the steps already taken in the National Capital Region (NCR), the union health minister said dengue and malaria strike with sickening regularity every year, resulting in many deaths. Prevention of this tragedy is easy only if the prevention protocol is implemented with commitment and monitored personally by the highest officials aggressively and pro-actively, he stated, adding that accountability must be fixed at all levels. Dr Harsh Vardhan said, "Let us make a new beginning. Let us not be complacent if the number of victims this year is less than last year's. We must aim for zero incidence within two to three years." Compared to 353 cases of malaria in 2013, Delhi has already reported 11 by June 30. Uttar Pradesh had 48,346 and 6,473 respectively for 2013 and up to June-end this year. Dengue has already claimed nine victims in Delhi, 89 in Rajasthan and three in Haryana. However, there have been no cases of death from the disease so far this year. The health minister, who recently toured the United States where he had a four-hour-long meeting with experts at the Centre for Disease Control, said he is convinced that 80 percent success rate is assured if well-known preventive steps are implemented. Aware of the necessity of bringing the states on board to bring plan in to effect, to eradicate preventable diseases, Dr Harsh Vardhan said he was keen to integrate into a strategy the success stories of states like Tamilnadu and Karnataka where the incidence of vector-borne diseases has registered a dramatic fall, thanks to concentrated action and community involvement. He said he would also send central health officials to all the states to take stock of the situation on the health front through meetings with their counterparts. "There cannot be a one-size fits all policy. Each region is different and needs an unique solution. This will be discussed in the CCH," he said. The meeting was attended by Mr Narendra Singh, health minister of Haryana, Mr Rajendra Singh Rathore, health minister of Rajasthan, Mr Najeeb Jung, lieutenant-governor of Delhi, mayors of North and East Delhi, and senior officials of health ministry and state governments. Mr Jung said at the meeting that preventive steps are already under implementation in the capital. It has been decided to carry out a poster drive in schools, metro stations, bus stands and markets to spread awareness on the symptoms of dengue. Wards have already been earmarked in hospitals for the exclusive use of dengue patients, he stated. Dr Deepak Upreti, Rajasthan's principal secretary (Health) told the meeting that apart from allopathic intervention, lessons should be taken from the Ayurveda where herbs and grasses prove highly effective. Dr Harsh Vardhan said he acknowledged the supremacy of Ayurveda and assured that the Department of Ayurveda, Yoga, Unani, Siddha, Homeopathy would be instructed to involve the synergies already available. ]]> <![CDATA[Medical devices industry puts up its budget wishlist]]> https://biospectrumindia.com/news/95/3597/medical-devices-industry-puts-up-its-budget-wishlist.html https://biospectrumindia.com/news/95/3597/medical-devices-industry-puts-up-its-budget-wishlist.html Thu, 03 Jul 2014 14:33:16 +0530 According to AdvaMed, an association of medical device manufacturers, which provides 40 percent of the medical technology used across the world, the medical devices market in the BRIC countries today accounts for nearly $10 billion, and this figure is growing at an average CAGR of 8 percent. It is somewhat startling that less than $2.50 (approximately Rs 155) is spent on medical technology per person. The under-penetration of medical devices in India provides a compelling opportunity for medical device manufacturers to increase their presence in the country, and expand access to healthcare under a conducive regulatory framework. It has suggested setting up Medical Technology Parks, where a cluster of manufacturers of medical devices are fostered through provision of basic infrastructure, which would encourage innovation. The association has also called for the inception of benefits such as reduced Customs duty on raw material, excise duty concessions, VAT holidays, IT holidays, etc. Said Dr Vibhav Garg, vice-chair of AdvaMed's India Working Group, "The global medical device industry has, over the past decade, shifted its focus from traditional developed markets to emerging markets. The increased demand from these new markets is due, in large part, to the rise in non-communicable diseases." Furthermore, there is a need for R&D grants and subsidies in the Medical Technology space to promote Domestic Innovation initiatives. "To ensure that there is thrust in the Research and Development area for design as well as innovation of these products, special incentives must be offered to get more participants in this," Ms Abby Pratt, vice president of AdvaMed said. "As the benefits to society from such projects would be significant, the medical device industry is suggesting that incentives in the form of Income Tax write-offs for up to 250 percent of the value of investment for R&D and innovation of Medical Instruments, Diagnostics Instruments, Consumables, Devices, etc. be offered." ]]> <![CDATA[Indian pharma to put up a grand show at Tokyo fair]]> https://biospectrumindia.com/news/95/3104/indian-pharma-to-put-up-a-grand-show-at-tokyo-fair.html https://biospectrumindia.com/news/95/3104/indian-pharma-to-put-up-a-grand-show-at-tokyo-fair.html Wed, 02 Jul 2014 17:57:46 +0530 The Indian Department of Commerce is showcasing the achievement of the country's pharmaceutical sector at the 'Brand India Pharma' show in the Tokyo fair. The three-day show, Interphex and Inpharma trade show in Tokyo provides a platform for over 100 Indian companies to connect with the Japanese market and showcase manufacturing and research capabilities of the country's pharmaceutical industry. The Indian government, in a bid to highlight the value proposition that the country's pharma sector presents to the global market, has come up with this campaign. The Indian Commerce Secretary, Mr Rajeev Kher, led the country's delegation to the trade exhibition. Mr Habil Khorakiwala, Chairman of Wockhardt headed the industry delegation, the Federation of Indian Chambers of Commerce and Industry (FICCI) said in a news statement. "Given the heavy pressure on the health requirements, especially its ageing population, Japan, which is a USD 119 billion market, of which generics constitute 11 percent, decided to enlarge its generics portfolio. Japan represents an opportunity for the Indian pharmaceutical industry," it explained. FICCI further added, "Under India's Comprehensive Economic Partnership Agreement (CEPA) with Japan, which is a conscious agreement to mutually increase cooperation in the pharma sector, Japan has extended national treatment to Indian companies." "This new dimension of India's strategy coincides with developments in Japan. Given the heavy pressure on the health requirements, especially its aging population, Japan, which is a $119 billion market, of which generics constitute 11 percent, has decided to enlarge its generics portfolio. Japan today represents an opportunity for the Indian pharmaceutical industry. India's CEPA with Japan, which is a conscious agreement to mutually increase cooperation in the pharma sector, an element of this is the fact that Japan has extended national treatment to Indian companies," the statement added. The statement cited, that India with a 35 percent share, ranks the highest in terms of filings of (Drug Master File) DMF filed with USFDA. As much as 25 percent of the manufacturing sites registered with EDQM are from India. Mr Rajeev Kher said that India is rebranding itself as not only the pharmacy to the world, but also the "responsible health care giver" to the world. He added that Indian medicines are not only affordable and of top quality meeting the regulatory requirement of the toughest regulatory markets in US and EU, but now include all the arms of the health care, generics, innovator drugs, medical equipments, vaccines, surgical and non-surgical interventions in state of art hospitals. He mentioned, "India is doing cutting edge work in biologics and biotechnology as well as nanotechnology." He also said that in terms of drug discovery and R&D spend, "India figures amongst world`s top three countries." In his keynote speech, he explained that, "There is a win-win possibility for both India and Japan in pharma cooperation." ]]> <![CDATA[Health Ministry to set up e-health regulator]]> https://biospectrumindia.com/news/95/3100/health-ministry-to-set-up-e-health-regulator.html https://biospectrumindia.com/news/95/3100/health-ministry-to-set-up-e-health-regulator.html Wed, 02 Jul 2014 17:40:29 +0530 "We need to have an e-health authority which will be the regulator and which will see that EHR standards are being adhered to," said Mr Lov Verma, secretary, Ministry of Health and Family Welfare while addressing a conference organised by Associated Chambers of Commerce and Industry of India. The Health and Family Welfare Ministry is also in the process of standardizing codification for health procedures in India and framing metadata and data standards (MDDS) for health sector, informed the secretary. "MDDS will facilitate interoperability of e-governance applications by providing a common data information model for various stakeholders in the health system - national and state, public and private, to begin sharing meaningful information with each other in a timely manner," he said. Talking about the importance of bringing in information and communication technology into the healthcare system, Mr Verma said, "With the adoption of ICT in health systems, we are hoping to achieve remote consultation, diagnosis and treatment through tele-medicine, and also facilitate collaboration and co-operation among healthcare providers." He said the current method of paper-based record keeping system makes a lot of key information inaccessible to patients as well as healthcare providers, which add to the problems being faced by patients. ]]> <![CDATA[India to set up IT, pharma industrial parks in China]]> https://biospectrumindia.com/news/95/3021/india-to-set-up-it-pharma-industrial-parks-in-china.html https://biospectrumindia.com/news/95/3021/india-to-set-up-it-pharma-industrial-parks-in-china.html Wed, 02 Jul 2014 15:58:22 +0530 "The idea is that the Chinese could set up their industrial parks in India, in fields they are strong in. Similarly, India could set up industrial parks in China in areas like IT and pharmaceuticals," said Mr Jagat Shah, interim secretary-general, China India Trade and Investment Centre (CITIC). The NDA Government believes that the move will help address India's widening trade deficit with China. Earlier this month, a 20-member Chinese business-cum-investor delegation had short-listed three locations near Sanand in Ahmedabad district for setting up their units. The units are to be set in an industrial park with an initial investment of $1 billion. They are likely to meet the Gujarat Government again for finalizing the proposal. China is interested in investing in India especially in automotive, electronics, agro-processing, tourism, and manufacturing. It will participate in setting up of industrial parks in the country. The country has emerged as India's biggest trading partner in the current fiscal, replacing UAE and pushing it to the third spot. ]]> <![CDATA[Maharashtra to get new agri-research institutes]]> https://biospectrumindia.com/news/95/5801/maharashtra-to-get-new-agri-research-institutes.html https://biospectrumindia.com/news/95/5801/maharashtra-to-get-new-agri-research-institutes.html Wed, 02 Jul 2014 12:31:14 +0530 The center will look into the problems of Maharashtra farmers, especially to deal with any low-rainfall situation, and also create R&D infrastructure to support long-term growth of agriculture in the State. A delegation led by members of parliament and state legislature of Maharashtra viz. Mr Devendra Fadnavis, Mr Eknath Khadse, Mr Vinod Tawde, Mr Hansraj Ahir and Mr Sanjay Patil, met agriculture minister, Mr Radha Mohan Singh on July 01, 2014 and gave him a representation on farming matters. Responding to their demands, the agriculture minister assured them that his Ministry would favourably consider the establishment of a Central Agricultural University in the state. Their demand for a second Krishi Vigyan Kendra in bigger districts and opening of ICAR institutes on diary farming, soil and water testing, integrated pest management and horticulture will also be looked into, the minister said. The minister said that many parts of Maharashtra are prone to low rainfall and drought, and he has been informed that the water level in reservoirs is going down. Agriculture Ministry is, therefore, closely monitoring the progress of the monsoon, especially over dryland areas. In case of poor or scanty rainfall, a contingency plan will be put into operation in the affected districts. The Agriculture Ministry is also in constant touch with the State government, the Minister shared with the delegation. ]]> <![CDATA[DNA mapping, RNA engineering among top ten innovations by 2025]]> https://biospectrumindia.com/news/95/5192/dna-mapping-rna-engineering-among-top-ten-innovations-by-2025.html https://biospectrumindia.com/news/95/5192/dna-mapping-rna-engineering-among-top-ten-innovations-by-2025.html Wed, 02 Jul 2014 12:28:26 +0530 The Intellectual Property and Science business of Thomson Reuters, the world leader in providing intelligent information to businesses and professionals, has released 'The World in 2025: 10 Predictions of Innovation', a new report that predicts the landscape of science and technology in 2025 by mining global patent data and scientific literature. To conduct the study, researchers identified the top 10 emerging scientific research fronts, based on an analysis of citation rankings using Thomson Reuters Web of Science. They next looked at global patent data in the Derwent World Patents Index to identify the top 10 patent fields with the highest number of inventions containing a priority date of 2012 and beyond. The resulting technology areas with the highest level of commercial and scientific research interests were then reviewed to identify hot spots of innovation that will lead to tomorrow's biggest breakthroughs. Among the top 10 innovations featured in the list, the lifesciences technologies that are predicted to make significant impact include: â€¢ Type 1 Diabetes is preventable: Advancements in ribonucleic acid-guided (RNA-guided) engineering will advance to a point where it will be possible to create a human genome engineering platform for identifying and treating disease-causing agents in humans. This field currently leads all areas of genetic-engineering patenting and has been identified as an emerging research front in scientific literature. â€¢ DNA mapping at birth is the norm: Analysis of the human genome continues to be one of the hottest areas of scientific research, with one recent paper collecting over 1,000 citations. Advancements in nanotechnology coupled with more widespread Big Data technologies make invivo measurements, for diagnoses to conduct precise, cell-level screenings, possible. Additional predictions from the lifesciences segment included Cancer Treatments with very few toxic side effects; Petroleum-based packaging is replaced by cellulose-derived packaging. ]]> <![CDATA[BIO 2014: Taiwan promotes its biotech industry ]]> https://biospectrumindia.com/news/95/6601/bio-2014-taiwan-promotes-its-biotech-industry-.html https://biospectrumindia.com/news/95/6601/bio-2014-taiwan-promotes-its-biotech-industry-.html Tue, 01 Jul 2014 16:46:48 +0530 The Taiwan biotech industry left no stone unturned to promote its aggressively growing Biotech industry at the 2014 BIO International Convention held at San Diego. "Taiwan's biotechnology and pharmaceutical companies have become potential partners for big industry players," the head of the Taiwanese delegation at BIO2014, Mr Chiang Been-huang said in a statement. He further added that Taiwan's biotechnology companies were flourishing and this convention would help in establishing more global partnerships, which would mark the presence of Taiwan in the world market. At the convention, the Taiwanese companies showcased their new medicines and other healthcare ventures aiming to attract potential industry players to invest in the country's biotech parks. The country's biotechnology sector was represented by a dozen leading Taiwanese biotechnology companies and government agencies. Mr Been Huang said that the biotech industry in Taiwan was growing fast and would play an instrumental role in shaping the economy of the country. He said that the convention would play a major role in influencing many foreign companies to invest in Taiwan's biotech sector. ]]> <![CDATA[Health min seeks CDC help to tackle JE, Dengue & TB]]> https://biospectrumindia.com/news/95/2967/health-min-seeks-cdc-help-to-tackle-je-dengue-tb.html https://biospectrumindia.com/news/95/2967/health-min-seeks-cdc-help-to-tackle-je-dengue-tb.html Tue, 01 Jul 2014 15:09:05 +0530 Union health minister Dr Harsh Vardhan during his recent US visit, held a four hour long meeting with top experts at the world famous Centre for Disease Control and Prevention (CDC) at Atlanta. During the talks, the health minister highlighted the annual visitation of Japanese encephalitis and acute encephalitis syndrome (AES) which leads to heavy loss of life in Uttar Pradesh and Bihar. The minister, who is on an official tour of the US, said, "Though I have personally visited the affected areas of the two states recently and overseen an immunisation drive, I feel that CDC's research assistance could go a long way in understanding the root causes (etiology) of AES which is still a mystery. So I made a request to Dr Tom Frieden, director in this regard. Dr Harsh Vardhan also discussed the possibility of CDC giving technical assistance for development of early warning, epidemic preparedness and response, development of field friendly rapid diagnostic kits and bilateral cooperation for development of Dengue vaccine. The minister visited the Emergency Operations Centre of CDC. Dr Steve Monroe, one of the senior functionaries, highlighted the emerging and zoonotic infectious diseases which are of grave concern before the world community. During the talks, the problems faced by India in combating multi-drug resistant (MDR) TB were raised. The CDC's scientists had identified major problems in India as being poor health coverage, inadequate data on the rising MDR cases and cases of hospital employees catching the infection. There was much focus on tobacco control, environmental and occupational medicine. The Minister and the CDC specialists exchanged views on programs for diabetes, hypertension, ending the culture of physical inactivity and on the need for strengthening global health security. Dr Harsh Vardhan requested Dr Frieden that the CDC carry out an objective assessment of India's TB control program. The CDC director suggested that the Indian government strengthen the program's management at the national, state and district levels. The health minister reiterated his intention of making health for all a social movement in India. Dr Frieden responded by saying that the excellent social mobilisation network set up for the pulse polio mission in India should not be dismantled. Rather it should be used for achieving 100 percent immunisation coverage for all vaccine preventable diseases, with a special focus on measles elimination and rubella control for the near future. The CDC delegation shared information with the visiting Indian minister on research progress in a variety of diseases. The future could see more collaboration between India and this premier institute. The health minister announced that it had been decided that CDC would designate a doctor who would work for better coordination of Indian projects that the organisation handles, by acting as a communication bridge between the Director and India's Health Minister. ]]> <![CDATA[US Pharma: Intitate dialogue to resolve IP issues]]> https://biospectrumindia.com/news/95/5592/us-pharma-intitate-dialogue-to-resolve-ip-issues.html https://biospectrumindia.com/news/95/5592/us-pharma-intitate-dialogue-to-resolve-ip-issues.html Tue, 01 Jul 2014 09:33:36 +0530 Corporate executives attending the day-long "US-India BioPharma and Healthcare Summit" organised by the US-India Chamber of Commerce said that they should not be considered adversaries by New Delhi. The executives stated that both India and global pharma companies shared the same goal of providing best healthcare services to patients. They further added that they are willing to work with India to come up with a solution, which would be acceptable to the both the parties. "We can sit around a table and have a dialogue. We need to go from considering the diligence as untrustworthy, to working together to help patients. The only way we can do it is by collaboration and really having a dialogue," said Ms Bahija Jallal, executive vice-president of MedImmune, a prominent bio-tech company. Dr Robert Langer, professor at the David J Koch Institute, Massachusetts Institute of Technology (MIT), argued that not caring about intellectual property would destroy innovation in the long term. He said that patent logic is vital for enhancing many aspects of innovation. Outstanding universities, a strong and enforceable patent regime and an entrepreneurial environment are key to building an innovation ecosystem in any country, Mr Langer said. American pharma companies want to be active in India. They want to help bring innovative medicines to the citizens of the country, informed Mr William Chin, executive VP of PhRMA, a top trade group representing the pharmaceutical research and biopharmaceutical companies in the US. He further said that they also know that India must weigh its patients and additional needs aganist resources. "I do hope that there can be a conversation about appreciative repayment and risks," He added. ]]> <![CDATA['Government needs to invest $5 bn per year']]> https://biospectrumindia.com/news/95/3775/government-needs-to-invest-5-bn-per-year.html https://biospectrumindia.com/news/95/3775/government-needs-to-invest-5-bn-per-year.html Tue, 01 Jul 2014 09:30:12 +0530 "To make bio-manufacturing the next big thing after generics for India, invest $4-5 billion each year in the next five years to grow the biotech industry to $100 billion by 2025," PwC India leader for pharma and lifesciences, Mr Sujay Shetty said in a statement. The consultancy firm also suggested that the government should eliminate service tax for domestic contract research organisations (CRO) and encourage setting up of venture capital funds for investments in biotechnology. "Service tax for the CRO industry is putting Indian companies at a significant disadvantage over some of our neighbors and competitors. We request elimination or substantial reduction in service tax, especially for overseas clients paying in foreign currency," Mr Shetty said. "All contributions by Indian corporates including pharma companies to SEBI registered biotechnology funds should be eligible for the weighted average tax deduction," he added. The firm has urged the government to give 100 percent exemption of excise or customs duty on all lifesaving medicines including anti-cancer and anti-AIDS drugs. It further suggested that the government hike FDI in health insurance companies to 49 percent. ]]> <![CDATA[First ever BMJ Awards India announced]]> https://biospectrumindia.com/news/95/6782/first-ever-bmj-awards-india-announced.html https://biospectrumindia.com/news/95/6782/first-ever-bmj-awards-india-announced.html Mon, 30 Jun 2014 14:50:29 +0530 The awards are being held with an aim to recognise individuals, organisations, and initiatives that demonstrate outstanding and measurable contributions across the healthcare community in India. The awards will celebrate the exceptional work being done by doctors in India, across the breadth of the Indian healthcare landscape-right from the metros to the rural towns of the country. The categories reflect BMJ's values and include awards for ground-breaking research, inspirational leaders and innovations to improve patient care. Dubbed the medical "Oscars", the event has become a key date in the medical calendar in the UK. Mr Anand Ekambaram, managing director, BMJ India said, "BMJ aims to improve health and make a real difference to clinical practice worldwide. We are delighted to launch BMJ Awards India to honour courage, determination, vision, and insight in medicine across the country. BMJ Awards India will not only provide a platform to enhance the existing relationship with the healthcare community but will also offer an opportunity to meet key influencers in the country. We hope to make it the 'Oscars' of medicine in India." The BMJ Awards have been established in the UK since 2009 and have even attracted winning entries directly from India in recent years. In 2011, there were two winners from India in the categories of "Innovation in Healthcare and "Medical Team in a Crisis Zone". Dr Anita Jain, India editor, the BMJ, said, "We are excited to create a platform for doctors to present their outstanding contributions in medicine through the BMJ Awards India. Our ambition is to highlight some of the best healthcare initiatives in the country and to inspire, motivate, and support the endeavours of Indian healthcare professionals." The BMJ Awards India nomination process will start in June and culminate on the 20th of September at a glittering ceremony in New Delhi, where shortlisted individuals and teams will be honoured amongst a prestigious audience of leading figures from healthcare in India. The winners and shortlisted teams will receive extensive coverage and recognition in the Indian media. Award categories span across various healthcare segments such as preventive health, innovation in healthcare technology, research paper of the year, excellence in medical education, quality improvement in healthcare, primary healthcare in challenging circumstances, healthcare campaigning or advocacy, surgical team of the year and medical team of the year. ]]> <![CDATA[Cipla acquires 51% stake in Yemen]]> https://biospectrumindia.com/news/95/6006/cipla-acquires-51-stake-in-yemen.html https://biospectrumindia.com/news/95/6006/cipla-acquires-51-stake-in-yemen.html Mon, 30 Jun 2014 13:21:38 +0530 Given the recent preference to local manufacturing, this secures the company's presence in a fast growing market. Cipla already has a leading position in Yemen with over 200 products according to a press statement. The company will pay $21 million for this transaction, with additional considerations to be paid over the next 3 years on achievement of agreed milestones. According to Cipla, closing of the transaction is subject to completion of certain conditions precedent. ]]> <![CDATA[Ranbaxy to launch generic Diovan in US]]> https://biospectrumindia.com/news/95/4411/ranbaxy-to-launch-generic-diovan-in-us.html https://biospectrumindia.com/news/95/4411/ranbaxy-to-launch-generic-diovan-in-us.html Mon, 30 Jun 2014 12:43:00 +0530 In spite of regulatory downfalls and issues, India's leading drug maker, Ranbaxy Laboratories has finally decided to launch the generic version of Diovan in the its biggest market - US. The company enjoys a 180 days exclusive marketing opportunity and will be launching the first generic version of Swiss drug maker Novartis' Diovan (Valsartan) in the US market. The launch of this generic has been on hold since September 2012 and is said to now take place immediately without any delay, as the company has received the crucial US Food and Drug Administration (FDA) nod. Addressing a conference in its home country in April, Ranbaxy's CEO Mr Arun Sawhney had said that the company is confident that it retains the exclusivity opportunities in US and would monetize it. Meanwhile, Ranbaxy was bought over by another large Indian drug maker Sun Pharma in April in a transaction worth $4 billion. Post the merger, it is said that the combined company would be the largest pharma company in the domestic pharma space and fifth largest generic drug firm globally. Its present Japanese parent, Daiichi Sankyo, however would continue to hold a 9 percent stake in the company after the takeover is complete. News reports added that Ranbaxy's next big test is the launch of generic version of AstraZeneca's Nexium (esomeprazole magnesium), which commands sales of over $5 billion, and was expected in May. ]]> <![CDATA[Global nutra market growing at 6.3%]]> https://biospectrumindia.com/features/95/5983/global-nutra-market-growing-at-6-3.html https://biospectrumindia.com/features/95/5983/global-nutra-market-growing-at-6-3.html Fri, 27 Jun 2014 14:23:00 +0530 Nutraceutical, a portmanteau of the words "nutrition" and "pharmaceutical", is a food or food product that provides health and medical benefits, including the prevention and treatment of diseases. The term nutraceutical was originally defined by Dr Stephen L DeFelice, founder and chairman of Foundation of Innovation Medicine (FIM), Crawford, New Jersey. Nutraceutical foods are not subject to the same testing and regulations as pharmaceutical drugs. In addition, many botanical and herbal extracts such as ginseng, garlic oil, etc. have been developed as nutraceuticals. These are often used in nutrient premixes or nutrient systems in the food and pharmaceutical industries. There is minimal regulation over which products are allowed to displayed under the term nutraceuticals, on their labels. Because of this, the term is often used to market products with varying uses and effectiveness. The definition of nutraceuticals and related products often depends on the source. Members of the medical community require that the term 'nutraceutical' should be more clearly established in order to distinguish between the wide varieties of products out there. The preference for the discovery and production of nutraceuticals over pharmaceuticals is well seen in pharmaceutical and biotech companies. Some of the pharmaceutical and biotech companies, which commit major resources to the discovery of nutraceuticals include Monsanto, American Home Products, Dupont, Abbott Laboratories, Warner Lambert, Johnson and Johnson, Novartis, Metabolex, Genzyme Transgenic, PPL Therapeutics, and Interneuron.Global market scenario Nutraceuticals provides health benefits and helps in prevention and healing of diseases. The global nutraceuticals product market is primarily categorized on the basis of functional foods, functional beverages and dietary supplements. The global market of nutraceuticals is growing on account of growth in the dietary supplement segment. Some of the factors driving the nutraceutical market are increase in disposable income and increased consciousness about one's health. The expenditure for buying healthy and organic foods increasing and thus, giving a boost to the overall nutraceutical market. Some of the factors restraining the market growth are the lack of knowledge about the benefits of nutraceutical products and high prices of the same. Global nutraceutical market-Food, Beverages and Supplements (2009-16) ($mn) According to a new market report published by Transparency Market Research "Nutraceuticals Product Market: Global Market Size, Segment and Country Analysis and Forecasts (2007-2017)", Global Nutraceutical Product market reached $142.1 billion in 2011 and is expected to reach $204.8 billion by 2017, growing at a CAGR of 6.3 percent from 2012 to 2017. Asia Pacific (including Japan) is expected to have the second largest market share after North America by 2017. In 2011, the Functional food and Beverage market reached $93.0 billion, registering a growth rate of 6.0 percent from 2007 to 2011. North America enjoyed the highest market share for nutraceutical products at $56.4 billion in 2011. Among all the geographies, North America has the largest consumer base for Nutraceutical products. Although the market is at a mature stage in this region, it has witnessed a growth rate of more than 6 percent during 2007-2011. Developing countries like China and India possess huge potential both in terms of value and volume for Nutraceutical products, as the population and disposable income is on a rise in these countries. Functional Food remained the fastest growing segment of North America's nutraceutical market at 6.5 percent CAGR during 2007-2011. Non Herbals segment was the fastest growing segment of North America's dietary supplement market during 2007-2011, whereas proteins and peptides market segment had the largest share of revenue of North America dietary supplement market in 2011. The fact that the entire nutraceutical market is currently learning about the consumer range of choices, which has no limit, is giving rise to rapid product introduction in the region. The functional beverage market in the US is expected to have a moderate growth rate as compared to the dietary supplement market in the region. Dietary Supplement market remained the fastest growing segment of the Middle East and Africa (MEA) nutraceutical market at 30.8 percent CAGR during 2007- 2011. Non Herbals segment was the fastest growing segment of MEA dietary supplement market during 2007-2011 whereas Proteins and Peptides market segment has the largest share of revenue of MEA dietary supplement market in 2011. The Global Nutraceutical market is estimated to have a growth rate of 6.6 percent during the period of 2012-2017 in the protein and peptides segment of dietary supplement market. The non herbal segment of dietary supplement market will have a growth rate of 6.3 percent from 2012 to 2017. The omega fatty acid fortified food segments of functional food market will have a growth rate of 6.7 percent during the forecasted period. The North America and Asia Pacific nutraceutical market is expected to have a market share of 39.2 percent and 30.4 percent respectively in 2017. The dietary supplement market will be the fastest growing market from 2012 to 2017 as it helps in improving the body's ability to heal and protect itself. The Asia Pacific Nutraceutical product market is an emerging market in dietary supplements and the functional food segment. Japan is the largest consumer of nutraceuticals. China is the second largest consumer of nutraceutical products as people become more conscious about their food habits and have the largest population in the world. The functional food market in India is expected to have a moderate growing rate as compared to the dietary supplement segment in the region. The functional food and beverage market in India is expected to grow upto 70.74 percent as compared to the dietary supplement market in 2017. The Eastern Europe Nutraceutical product market is growing on account of high growth in functional food, and dietary supplement segments. Russia is the largest consumer of nutraceuticals in the region. The growth in nutraceutical products is taking place due to increasing old age population in the region. The Russian and Hungarian nutraceutical market is expected to have a market share of 24.4 percent and 20.2 percent respectively in 2017. The increase in disposable income of Eastern European consumers over the evaluation period 2012-2017 could also help in faster adoption of the nutraceuticals product adoption in the region. According to the report on research and markets by the Global Nutraceuticals Market report, the market is expected to grow at a CAGR of 6.3 percent over the period 2013-2018. One of the key factors contributing to this market growth is the increasing global ageing population. The Global Nutraceutical market has also been witnessing an increase in nutraceutical product development. However, the threat of ingredients and raw material contamination could pose a challenge to the growth of this market. Some of the leading names in this market include Archer Daniels Midland, BASF SE, GlaxoSmithKline, and NestlÃ© SA Bactolac Pharmaceutical, Bayer Healthcare AG, NBTY, and Perrigo. The report noted that the Global Nutraceutical market is highly competitive and has numerous local and international vendors prevailing in it. To compete in the market, vendors are introducing numerous new and innovative nutraceutical food products in the market. Companies are trying to introduce new innovative products on the basis of ingredients, packaging, and serving ability. As consumers are also increasingly interested in tasting new products, new flavors, and recipes, foods that have been developed using several cultural cuisines are also continuously being launched in the market. For instance, large food corporations, such as Kellogg, General Mills, Procter and Gamble, Hygiene and Health Care, are at the forefront of nutrition research. They are trying to gain advantage from nutraceuticals by fortifying their existing products (eg., orange juice with calcium), repositioning products, supporting sales with new marketing approaches and research that highlights the benefits of their core products and new products. Therefore, the increase in innovative nutraceutical food product launches is one of the key trends that is expected to propel the growth of the Global Nutraceutical market during the forecasted period. According to the report, one of the major drivers in the market is the increasingly aging population across the globe. With the increase in the aged population and primary consumers, the consumption level of nutraceutical products has increased. The majority of the demand for nutraceutical products is from the APAC region as the region is densely populated with changing consumer lifestyles and increasing disposable income. ]]> <![CDATA[IDMA: Lift excise duty on R&D and samples]]> https://biospectrumindia.com/news/95/5374/idma-lift-excise-duty-on-rd-and-samples.html https://biospectrumindia.com/news/95/5374/idma-lift-excise-duty-on-rd-and-samples.html Thu, 26 Jun 2014 16:58:41 +0530 The drug makers' association has sent a memorandum to the Finance Ministry requesting that all excisable goods used for Research and Development purposes be exempted from Central Excise Duty. They also want the same to be applied to capital goods, raw materials, consumables, and reference standards used for research. "Pharma manufacturers are required to keep a few boxes from each batch of a medicine manufactured till its expiry as 'control samples', as per the provisions of the Drug and Cosmetic Act and Rules. These cannot be sold and hence, should be fully exempted from Central Excise Duty. Similarly, medicine samples are provided to doctors as 'physician's samples', which should also be kept out of the purview of all duties and taxes," IDMA said in the memorandum. IDMA expects that the weighed deduction of 200 percent for R&D expenses in an in-house facility will be extended for further period of five years, it said. The industry body complained that in the last few budget presentations, the pharma industry has been overlooked and are anticipating a positive response from the new government. "This year, we expect the dynamic and forward thinking new government to create a transparent atmosphere of confidence and trust, and provide suitable incentives and concessions to keep our growth momentum going," it said. ]]> <![CDATA[MM Activ signs integral MoU at BIO 2014]]> https://biospectrumindia.com/news/95/6713/mm-activ-signs-integral-mou-at-bio-2014.html https://biospectrumindia.com/news/95/6713/mm-activ-signs-integral-mou-at-bio-2014.html Thu, 26 Jun 2014 16:13:00 +0530 San Diego: India's leading integrated science and technology knowledge and B2B communciations enterprise, MM Activ Sci-Tech Communications announced the signing of an integral Memorandum of Understanding. The company announced the partnership with Georgia's Innovation Crescent at the on-going global biotechnology event, BIO 2014 International Convention. As per the MOU, the Innovation Crescent Regional Partnership (www.innovationcrescent.com) and MM Activ Sci-Tech Communications (www.mmactiv.in) have formally agreed to support each other in the development of life sciences in Georgia and India. With the signing of the MOU, the two organisations have agreed to be supportive of collaborative research and development, information sharing, education, and other areas that provide the building blocks for innovative and cutting-edge life science industries. The announcement further specified that Georgia's Innovation Crescent has been a leading example of successful life science clusters since 2008, featuring more than 400 life science companies, non-profit organisations, universities and government agencies that work together to advance the industry. "This agreement is further evidence of the ongoing working relationship between the Innovation Crescent in Georgia, USA, and India," said Mr Nick Masino, Chairman of the Innovation Crescent Regional Partnership. "We have always and will continue to welcome the collaborative efforts of life science organizations in India as we strive to further life science research, development and investment in both regions," he added. "It is a continuation of our organisation's efforts to promote, develop and nurture collaborative activities that lead to innovation in life science institutions and companies between India and Georgia, USA," said Mr Narayanan Suresh, group editor of MM Activ Sci-Tech Communications. He assured further, "We will ensure that the red carpet is rolled out to all those who want to invest in India's fast-growing life sciences sector." "By signing this MOU, the Innovation Crescent and Georgia will move one more step forward in realising the full potential of research and development, academic and business opportunities," said Mr Ani Agnihotri, managing director of United States International Business and Research Center and chairman of the USA India Business Summit. Mr Agnihotri has been working with many Georgia-based organisations, including Georgia's Innovation Crescent and the Georgia Department of Economic Development, to be a leading state in growing bioscience business with India. ]]> <![CDATA[India & Canada working jointly on anti-malarial drugs ]]> https://biospectrumindia.com/news/95/5929/india-canada-working-jointly-on-anti-malarial-drugs-.html https://biospectrumindia.com/news/95/5929/india-canada-working-jointly-on-anti-malarial-drugs-.html Thu, 26 Jun 2014 13:35:13 +0530 Referring to the wide scope of collaboration between the two countries, Dr Jitendra Singh, minister of science and technology (independent charge) told a Canadian delegation, led by its high commissioner, Mr Stewart Beck about the action plan envisaging collaboration in the areas of biotechnology, health, environment, energy, food security, nano-technology science, communication and industrial R&D. Dr Singh also said that there will be an attempt to expedite ongoing projects between the two countries on 'PET-MRI Automatic Tumour Detection and Recognition' thus adding another dimension to non- invasive detection of tumour using PET and MRI images. The science and technology minister also revealed that two joint international patent applications by India and Canada have been filed under a project at the International Center for Genetic Engineering and Biotechnology (ICGEB), Delhi to develop new potential anti-malarial drugs. Dwelling upon future vistas, Dr Jitendra Singh said that the India-Canada science and technology relationship has the potential for future growth. "The need to connect the best academic and R&D institutions from both countries will be important for facilitating new knowledge creation through joint research and exchange of personnel," he added. A joint science and technology committee meeting of the two countries, according to Dr Singh, will be held in the first half of next year and it would aim at announcing new programs and initiating new awards for already existing programs. ]]> <![CDATA[Aging population drives pain management markets]]> https://biospectrumindia.com/news/95/6356/aging-population-drives-pain-management-markets.html https://biospectrumindia.com/news/95/6356/aging-population-drives-pain-management-markets.html Thu, 26 Jun 2014 13:31:37 +0530 At the launch, Mr Vineet Singhal, Novartis OTC OU head, India and South East Asia, said, "Research shows us there is a felt need among consumers for a pain relief gel that not only provides relief from pain but also speeds up recovery.... Working professionals today currently use strong smelling ointments and creams. Unlike the current cream or gels available in India, Voltaren has a pleasant smell and is non-sticky, making it ideal for use during office hours." The product is made available in across India at a price of Rs 50 /- for a 15g tube, and Rs 95/- for a 30g tube. Other products available in market in the same category include Solaraze Gel, Pennsaid (diclofenac sodium topical solution), Pfizer's Feldene (Piroxicam) and other topical pain killers manufactured by BenGay and Aspercreme. According to Business Insights' market research titled, 'The Pain Management Market Outlook To 2016', in 2011, the global pain management market was estimated worth $22 billion in 2010. NSAID (non-steroidal anti-inflammatory drugs) formed the second largest segment of this market, with sales recording $5.4 billion. The report also says that the sales growth in the segment is driven by an aging global population and changing attitudes towards pain management. In 2011, the global market for OTC sales of topical analgesics was worth $4.1 billion. The US pain management market is the largest single market with sales of $13 billion, which makes up over half of the total market, and represents a significant opportunity for an effective and safe topical NSAID. Also, in 2012, the US topical NSAIDs market was estimated to be worth $500 million. ]]> <![CDATA[Agri minister urges ICRISAT to take up research in pulses]]> https://biospectrumindia.com/news/95/5702/agri-minister-urges-icrisat-to-take-up-research-in-pulses.html https://biospectrumindia.com/news/95/5702/agri-minister-urges-icrisat-to-take-up-research-in-pulses.html Thu, 26 Jun 2014 11:23:00 +0530 "Taking technologies that are ready to the doorstep of every small farmer in the country is a priority for the union government. With support from ICRISAT and other agricultural institutions, we will reach out to more farmers in rural India," said Mr Radha Mohan Singh, union minister for agriculture while on a visit to ICRISAT headquarters in India at Patancheru, Telangana on June 23, 2014. "We must improve the health of soil for the benefit of smallholder farmers. I urge ICRISAT to upscale plans to extend soil health cards to every farmer in the country," the minister added. Recognizing the importance of pulses in enhancing food security and incomes of smallholder farmers, the minister discussed with ICRISAT, the Union Government's priority in upscaling the cultivation of pulses and making them more competitive and attractive to farmers. He pledged additional support to the efforts of ICRISAT to enable a Pulses Revolution in India. ICRISAT director general Dr William D Dar, deputy director general-research Dr CLL Gowda and other members of the senior management team, briefed the minister on the various research programs at the institute. While visiting the ICRISAT Centre of Excellence in Genomics, the director general shared with the Minister the idea of an India Genome Center for Agriculture which has the potential to transform India into a global leader in genomics. The initiative focuses on areas critical to food security and aims to coordinate the work of all genomics institutes across the country. Enhanced support to value chains of nutri-cereals like sorghum and millet which have been traditional crops in most areas across the country is essential. With high nutritional composition and resilience to survive in dry areas, nutri-cereals will be critical to India's future, helping overcome malnutrition and to cope with climate change. ICRISAT has been working closely with several organizations in the country on sorghum and millet but recognizes the need for new intensified efforts to promote them robustly at the consumer level. ICRISAT's plans for a farmer-centric rainwater harvesting model were also detailed to the minister, while viewing a 3-D model of how watershed management benefits farming. Minister RM Singh also toured the Center of Excellence for Information and Communications Technology (ICT) in Agriculture, the RS Paroda Gene Bank and interacted with the scientists. He expressed keen interest in encouraging ICRISAT's highly successful ICT models Krishi Gyan Sagar and Krishi Vani-powered by the Green SIM. Krishi Vani, a mobile-mediated agro-advisory platform, is delivering voice messages in regional languages to smallholder farmers across Telangana, Andhra Pradesh and Karnataka, on weather, market, crop information, government schemes, nutrition, and health. He also enquired of ICRISAT's activities in states of Telangana, Karnataka, Uttar Pradesh, Bihar, and Jharkhand and urged scientists to intensify their efforts in mapping soil health. "The country and smallholder agriculture have benefitted hugely from the efforts, contributions and innovations of ICRISAT over the past few decades. I urge the institute to enhance and expand its activities to all states and help farmers mitigate climate adversities," the minister said. Responding to the minister's request, Dr WD Dar reiterated ICRISAT's commitment to help smallholder farmers in the dryland areas of Asia and Africa. "We will upscale our work, innovate and explore new ways and means to assist smallholder farmers move from poverty to prosperity. Through research activities, community-based interventions, and institutional and policy innovations, we will revolutionize smallholder agriculture together," Dr WD Dar informed the minister. ]]> <![CDATA[US BIO 2014 Trends: Gene therapy to treat heart disease ]]> https://biospectrumindia.com/news/95/1381/us-bio-2014-trends-gene-therapy-to-treat-heart-disease-.html https://biospectrumindia.com/news/95/1381/us-bio-2014-trends-gene-therapy-to-treat-heart-disease-.html Wed, 25 Jun 2014 18:43:39 +0530 San Diego, 24 June 2014: Millions of patients with myocardial ischemia due to coronary artery disease can look forward better days ahead. Generx Ad5FGF-4, a new gene therapy developed by Taxum Cardium Pharmaceuticals, based here in San Diego, has shown significant results in treating this condition that leads to excessive blood flow leading to cardiac arrest. Sharing the preliminary results of a global clinical study ASPIRE which involved more than 780 patients at the BIO convention here, Dr Timothy Henry, chief of Cardiology at the Cedars-Sinai Heart Institute said, "The new data from the study further supports findings of safety and efficacy from the four prior and published Generx angiogenic gene therapy (AGENT) clinical studies that have been conducted at over 100 medical centers worldwide." This represents another important step forward in the development of an innovative biology-based microvascular gene therapy tool for the interventional cardiologist designed to broaden the cycle of care for a large number of patients worldwide with myocardial ischemia, Dr Henry added in a press statement. "Heart disease is a leading global medical concern and is expected to be so for generations to come. Here at Cardium, we are focused on developing an effective and universally affordable cardiovascular gene therapy for ease of use within the current practice of medicine that can potentially be accessible to millions of patients with ischemic heart disease worldwide," said Dr Christopher Reinhard, Taxus Cardium's CEO and co founder of Cardium Therapeutics. ]]> <![CDATA[US BIO 2014 Trends: Cancer concerns]]> https://biospectrumindia.com/news/95/1372/us-bio-2014-trends-cancer-concerns.html https://biospectrumindia.com/news/95/1372/us-bio-2014-trends-cancer-concerns.html Wed, 25 Jun 2014 18:29:12 +0530 San Diego, June 24, 2014: A new paradigm shift is taking place in the treatment of cancer. Physicians armed with latest immune therapies which are combined with the existed targeted treatment methods such as chemotherapy are delivering better results in cancer patients, according to experts. The annual BIO convention kicked off on June 24 at San Diego, California, with a super session on "a new paradigm in oncology treatment" where the experts were unanimous that in the past decade, our understanding of cancer's disease mechanism, along with these new therapies are delivering better treatment outcome for patients. "Now our ability to learn about the response to modern therapies from patient is better. At the same with the use of latest computer software techniques data analytics are helping us to understand the disease mechanism more clearly. It will surely lead to more robust design of medicines," said Dr Donald A DePinho, president, the University of Texas MD Anderson Cancer Center and a leading oncologist. Added Dr Peter Lebowitz, head of oncology at Janssen Research said, "Now we have multiple mechanisms to understand the disease and with some of the new biological medical products, the treatment of cancer is leading to more understanding of the disease at the micro-level. Hopefully these factors will lead to even better therapies in the future." Cancer is the most targeted disease for developing products by the biotech industry. The US regulator FDA approved a record 13 anti-cancer drugs in 2013. Cancer drugs were more than half of the new drugs approved last year. Another factor advancing cancer care is the availability of quick diagnostic methods. ]]> <![CDATA[Indian remedy for Caribbean cholera outbreak]]> https://biospectrumindia.com/news/95/1221/indian-remedy-for-caribbean-cholera-outbreak.html https://biospectrumindia.com/news/95/1221/indian-remedy-for-caribbean-cholera-outbreak.html Wed, 25 Jun 2014 16:24:00 +0530 The annual cases of cholera in the Caribbean Islands was reduced by 75 percent in the first quarter of 2014, as compared to the same period last year, a new report said. Health officials attributed the success to the new oral cholera vaccine, Shanchol developed by India based Shantha Biotechnics, which was instrumental in containing the disease to a large extent. The Medecins Sans Frontieres (MSF), an international medical humanitarian organisation had set out to test the short term effectiveness of two doses of the Shanchol vaccine, in an outbreak that happened in Haiti in the Caribbean islands.Till now, health experts were hesitant to embrace new vaccines in outbreak situations, considering the fact that vaccines were very expensive and multiple doses would be needed to prove its efficacy. MSF described that Shanchol was much cheaper and required a low storage volume that would aid in easy deployment during outbreaks. MSF recommended the WHO to stock pile Shanchol vaccines to handle such outbreaks as it was cheaper, easier to produce and transport. With Shanchol delivering remarkably good results in the Caribbean islands, its potential use in other regions is being evaluated. ]]> <![CDATA[Collaborations within BRICS nations can boost health technologies ]]> https://biospectrumindia.com/news/95/5706/collaborations-within-brics-nations-can-boost-health-technologies-.html https://biospectrumindia.com/news/95/5706/collaborations-within-brics-nations-can-boost-health-technologies-.html Wed, 25 Jun 2014 14:36:00 +0530 "We have declared health collaboration as a priority to collectively enhance our partnerships with each other and other countries we are engaged with through bilateral and multilateral mechanisms," stated the additional secretary, ministry of health and family welfare, Mr C K Mishra who spoke at the launch of the June 2014 issue of World Health Organization (WHO) bulletin devoted to the theme "BRICS and Global Health" at New Delhi. He further added that the impact of affordable generic drugs to manage HIV and TB, vaccines for childhood diseases and also others to tackle meningococcal meningitis, Japanese Encephalitis, innovations in diagnostics, health service delivery, and Information technology based applications etc., are key contributions to global health that have emanated from BRICS countries. Speaking at the function, the additional secretary stated that BRICS involves nearly 40 percent of the world's population. After having achieved remarkable economic growth over the last two decades, they have taken important steps towards improving their health systems and the health of their citizens. BRICS have also gathered into a cooperation initiative around the most salient issues of their respective agendas, he stated. He remarked that while the world has long acknowledged the impressive strides that the BRICS countries have taken in the economic sphere, it is beginning to take note of increasing influence that our exemplary and innovative public health programs and policies are having in shaping global practices. Development and rapid adoption of appropriate and affordable health technologies is a key to ensure game changing interventions and reduce the burden of endemic and emerging communicable diseases, obtain desired health impacts in non-communicable diseases but also to address the escalating cost of health care, Mr Mishra said. Towards this, the BRICS countries seek to collaborate on enhancing our health technology development, assessment and adoption capacity, he added. He said that our countries are also pioneering approaches to address the double burden of disease we face due to a combination of existing and re-emerging infectious diseases with the rapid emergence of non-communicable diseases. He added that while we are very happy to have contributed to the success of the global eradication of poliomyelitis, we have several other communicable disease challenges, including the emergence of antimicrobial resistance to handle. The additional secretary stated that the approach towards attaining a desirable level of health by all segments of the society amidst the complex challenges that are faced has to incorporate `primary healthcare' which takes cognizance of broader, comprehensive and integrated service delivery mechanisms and interventions that also recognize and make use of our traditional knowledge and societal beliefs. ]]> <![CDATA[Lack of regulatory infrastructure & talent remain big hurdles ]]> https://biospectrumindia.com/features/95/5371/lack-of-regulatory-infrastructure-talent-remain-big-hurdles-.html https://biospectrumindia.com/features/95/5371/lack-of-regulatory-infrastructure-talent-remain-big-hurdles-.html Wed, 25 Jun 2014 14:24:37 +0530 Comparisons with the IT industry might look highly promising to outsiders but many believe that these are being overstated. Among the reasons is the availability of the kind of financial support that the former enjoys. While the focus of this industry has been largely on biopharma, the sub sectors such as industrial enzymes don't require any huge funding. Probiotics and nutraceuticals too require fewer amounts. The best way out to attract funds is to shift the focus onto the lesser known areas. Mr Jagannath Samavedam of Venture East explained, "We have invested in all sorts of companies including diagnostics, drugs, enzymes and recombinant products. This is great opportunity sector and we are all set to fund lifesciences with $3-8 million (20-50 crore) in each company but it depends." "We speak to a lot of outsiders, they are happy with Indians. Innovators have not been able to attract typical funding. How far can Rs40-50 crore take a biotech company? Products take 5-6 years to research market. That is the reality private VCs have to live with," says Mr Jagannath. When asked if quality issues are denting Indian image and impacting investments, a financial analyst responded, "There certainly are concerns around quality issues. Indian companies get miffed when asked about these issues and say it is just one or two incidents. the government is not the best deplorer of funds but has access to it. If the private sector can chip in, it can help in that." However, Mr Jagannath doesn't share that view. "The Indian government doesn't have that kind of money. Not expecting a different policy on funds but on land, water, air and affluent regulation," he said. Mr Ramesh Radhakrishnan, Artiman Venture feels that VCs are different from each other. "For example, we set the expectation with investors at 9-10 years but we have to be sure that there is Rs two billion exit." Since a large number of early stage companies fail, there is always a risk about the money. Questions might be raised about public money for private good. Said a financial expert, "The government has risk money for helping the industry mature. The private sector can take over. Government and private risk appetite varies. It can enable the ecosystem but don't expect it to take over." Mr Vishal Gandhi, managing partner and CEO, BioRx Venture Advisors feels, "We need a predictable regulatory policy so that the companies are able to plan their investments and product development stages. Also as a potential area, the focus can be on antibody conjugates and monoclonal antibodies." While VCs agree that there is need for investments in biosimilar manufacturing but the question that confuses them is whether there is infrastructure available to push early stage manufacturing to a bigger scale? Human resources constraint It is said that every year, 10,000 quality students are produced but not even 4,000 of them are absorbed. Training and retaining is a big headache for Indian companies. Most of them do their basic HR work all by themselves. Despite the availability of talent, it is difficult to retain people. "Lot of patience is required to stay on, said Dr Mandakini Sharma of Biocon while adding further, "In US, we have high school students doing autoclaving and running gels while in India, the MSc level people do the same. There lies the difference" Dr Gagandeep Kang, Christian Medical College, Vellore decried the lack of onus on research and development. She said, "There is hardly any orientation in the curriculum towards research or manufacturing" The Karnataka government is way ahead in this matter. Dr Jagadish Mittur, head-biotech facilitation center at KBITS talks about a committee wherein there are eight domains including the fermentation bioprocesses and nutrition biomanufacturing. "Karnataka Biotech Aptitude Test has selected 126 students this time but for next year we have 145 students,"said Dr Mittur as he goes on to add, "Companies in the west allow you to do multiple staffing. They allow you the freedom to do things." Agrees Dr Shams Yazdani, scientist and head-biofuel division, ICGEB, who asks a straight question. "Can we retain our talent here? The workforce generated at the moment is not enough I feel. Handholding of student entrepreneurs is required. Government cannot directly or indirectly interfere with the HR policies. Let the HR manager decide it." There is another issue to tackle. Those joining the industry are treated as second class academicians. Dr Shahid Jameel, CEO, DBT-Welcome Trust Alliance points out to the fact that academicians are judged by the publications and not the processes. "Post docs are paid less than Rs 28,000. It is nice to say that they should come back but what about the mindset that looks at the foreign experience of a student as a superior ingredient in his resume," asked Dr Jameel. Way forward: The due attention to bio-manufacturing can help in expanding the products basket, thereby extending the benefits of biotechnology to untapped potential areas. Building basic research capabilities followed by scaling up of manufacturing processes and finally streamlining of regulations and education can surely do wonders. But the road to a strong and stable bio-manufacturing industry passes through a lot of challenges. The effective mix of plans and decisions involving right partnerships, would decide the gateway to the future Note: The article is based on personal interactions and deliberations at 2nd Biotechnology Industry Research Assistance Council (BIRAC) Foundation day event held at New Delhi. ]]> <![CDATA[Patna AIIMS may be Mr Vajpayee's birthday gift]]> https://biospectrumindia.com/news/95/3800/patna-aiims-may-be-mr-vajpayees-birthday-gift.html https://biospectrumindia.com/news/95/3800/patna-aiims-may-be-mr-vajpayees-birthday-gift.html Tue, 24 Jun 2014 17:29:53 +0530 As per reports, Dr Harsh Vardhan has directed officials to complete the Patna AIIMS project by this year-end, at any cost so that it can be inaugurated on December 25, birthday of former PM, Mr Atal Bihari Vajpayee. The date assumes significance as Mr Vajpayee, during his tenure as the prime minister, had conceptualised the project in 2004. It was his idea to have six more AIIMS in the country, including the one at Patna. Speaking about the delay in completion of this project, he said, "My motto is to forget the past and look into the future. The country had another government for the last 10 years and so I will not comment on it." The Union Health Minister visited Patna on June 21 to take stock of the construction work. ]]> <![CDATA[India, US to discuss mutual cooperation in health research]]> https://biospectrumindia.com/news/95/5892/india-us-to-discuss-mutual-cooperation-in-health-research.html https://biospectrumindia.com/news/95/5892/india-us-to-discuss-mutual-cooperation-in-health-research.html Tue, 24 Jun 2014 16:50:08 +0530 "We are on a threshold of exciting possibilities. I am looking forward to talks seeking collaboration on global health security, telehealth and preventive healthcare," said Dr Harsh Vardhan. He will meet Ms Sylvia Mathews Burwell, newly appointed US secretary of health and human services on June 24. The purpose of the meeting would be to evaluate progress of the US-India Health Initiative, which was launched in 2010. The minister will also hold meetings with Dr Rajiv Shah, administrator; Dr Ariel Pablos Mendez, assistant administrator and Ms Denise Rollins, assistant administrator of United States Agency for International Development (USAID). This meeting will see discussions on steps to consolidate the collaboration that exists between Indian government, USAID, UNICEF and other lead partners in creating an AIDS-free generation. It also aims to achieve TB-free India and reaching Universal Health Coverage (UHC). It may be pointed out here that the USAID has recently launched a "Global Development Lab" which brings together a diverse set of partners to discover, test and scale breakthrough solutions to end poverty. Dr Harsh Vardhan stated, "As ending poverty is a priority area for the new government, this meeting will explore the potential to expand existing technical collaboration." On the second anniversary of India-US-Ethiopia initiative to launch annual "Call to Action-A Promise Renewed", Dr Harsh Vardhan will attend a meeting in the American capital on June 25 to take stock of the progress so far, in the war against child mortality. In all, 25 Health Ministers from different countries will be attending the meeting. Dr Vardhan will be delivering the keynote address highlighting the global vision for preventable child and maternal deaths. To conclude his Washington meetings, the minister will go to Atlanta, Georgia where he will visit the Centre for Disease Control and Prevention (CDC). An agreement of cooperation already exists between CDC and Global Disease Detection India Centre, established in 2011 at the National Centre for Disease Control. The areas of cooperation include strengthening Surveillance, Epidemic Intelligence Service training program and quality assurance. In addition, there exists a collaboration between CDC and Indian Council of Medical Research in the areas of environmental and occupational health, non-communicable diseases, etc. During his visit, Dr Harsh Vardhan will have talks with Mr Thomas R Frieden, director of CDC on the progress of the collaboration and new areas of cooperation in the future. ]]> <![CDATA[Tripura Malaria death roll rises to 41]]> https://biospectrumindia.com/news/95/4654/tripura-malaria-death-roll-rises-to-41.html https://biospectrumindia.com/news/95/4654/tripura-malaria-death-roll-rises-to-41.html Tue, 24 Jun 2014 14:04:05 +0530 "At least 41 people, including 31 children, have died and more than 22,000 have fallen ill since the first week of this month. Of the 22,000 affected people, the malaria germ has been found in the blood of 3,215 of them," Tripura Health and Family Welfare minister Mr Badal Choudhury informed. All the affected people have been admitted to various government hospitals. A team of malaria experts from the Union Health and Family Welfare Ministry, led by Mr Awadesh Kumar have been sent to supervise the situation and advise the state government on how to deal with the outbreak. The minister, along with medical experts, has visited the malaria-affected areas many times. "Several medical teams are working in the disease-affected areas. SOS has been sent to Tripura officials in Guwahati, Kolkata and Delhi to urgently send adequate quantities of medicines," he said. Chief minister Mr Manik Sarkar held a series of meetings with doctors, officials and ministers to review the situation. He asked his ministers to rush to the malaria-hit areas and stay there till the situation improves. ]]> <![CDATA[Are Phytopharmaceuticals an industry in the making?]]> https://biospectrumindia.com/features/95/3643/are-phytopharmaceuticals-an-industry-in-the-making.html https://biospectrumindia.com/features/95/3643/are-phytopharmaceuticals-an-industry-in-the-making.html Mon, 23 Jun 2014 17:37:00 +0530 Phytopharmaceuticals are medicinal plant-based pharma products from any part of the globe. These are very inclusive and boundry-less as compared to other traditional forms. The leads for these can have their origins in ASU, chinese medicine, Kampo medicine, Bhutanese medicine, tribal or any other sources. The interesting fact about this emerging bioscience industry is that it is being curiously watched and criticized by Ayurvedic companies. The latter fear that the phytopharma products might dilute their stakes and common people might feel that ayurvedic products lack quality. However, at the same time, the pharmaceutical industry that has almost gone defunct on serious drug discovery programs may find it exciting and eventually lap it up as an opportunity. A little backdrop of the recent activities might help a bit. The Government of India has published a draft amendment to Drugs and Cosmetics Act, and Rules (D&C Act and Rules) on October 24, 2013. This creates regulatory provisions for defining phytopharmaceuticals (botanical-based drugs) and a schedule providing requirements of scientific data on quality, safety, and efficacy to evaluate and marketing authorization for a plant-based lead as a drug on similar lines to synthetic, chemical moieties. There also has been a meeting of the commitee in June on the subject that will discuss and decide the recommendations to the government. Currently the definition and regulatory aspects of phtopharmaceuticals are being hotly debated. What makes the situation complex are the overlapping mandates of the Department of Ayush (DoA) and Central Drugs Standard Control Organisation(CDSCO) are required to be dealt with. The underlying hope comes from the fact that there would be more credibility as far as safety and efficacy are concerned as the companies that deal with these, would also conduct proper toxicology and human clinical trials unlike the traditional forms of medicines. Experts also place the onus on industry to put pressure on the government bodies and regulatory agencies to change certain guidelines. With plerthora of information available, there is not even any need to start from the beginning. It is important to note that there are 2400 codified plants and 3000 non-codified plants used by the tribals in India. The first ever Auyurvedic pharmacopoeia VolI was published in 1986 with 80 monographs. Though there have been many published works with fresh mongraphs, none has been granted any official status so far. Recently, the Biotechnology Industry Research Assistance Council (BIRAC) in collaboration with Clinical Development Services Agency (CDSA) organized a one day regulatory workshop on "Emerging Needs and Regulations on Phytopharmaceuticals" on June 18, 2014 at New Delhi. This was the 'Third Workshop' among the 'Regulatory Workshop Series' while the earlier two were on New Drugs and Biopharmaceuticals. The workshop brought together regulatory educators and experts from various institutes and industries. The goal of this workshop was to provide direct, relevant and valuable information on key scientific aspects of phytopharmaceuticals including its regulations in India. Its timing was welcomed by the participants and speakers who said that it was the need of the hour. "There is no scarcity of bioresources in India," says Dr Renu Swarup, managing director, BIRAC and senior advisor, Department of Biotechnology, adding that, "Industry has a very special role and that is moving from laboratory to critical product development." All funding bodies such as Indian Council for Medical Research (ICMR), Department of Science and Technology (DST), Council for Scientific and Industrial Research (CSIR)will have to work together to shape phytopharmaceuticals. This has to be a part of our exercise to expand and move towards $100 target." On the contentious regulatory scenario, Dr Swarup remarked that while it is essential, it should not be a barrier. Both over-regulation and under-regulation are a barrier and a science based approach is required for product development. "Modern medical science tried to eradicate plant ancestory but its good to see a comeback," said Dr S S Handa, former director, CSIR-Institute of Integrative Medicine (IIIM), Jammu. The renowned scientist feels that the time has come for redrawing the regulatory strategies and for removing the overlaps between the regulatory bodies. "We require a holistic health policy. Ayurveda and allopathy can work in tandem to create new medicines that benefit a huge number of patients. Infact, there is no need to start afresh as the leads that are already available could be leveraged to produce new drugs,"said eminent clinical Pharmacologist, Prof. Ranjit Roy Choudhury. Listing out the benefits of the emerging area of phytopharmaceuticals, Dr C K Katiyar, CEO Healthcare (Technical), Emami, Kolkatta, said, "It will boost the R&D based pharma companies and bring in required change in mindset, forcing investments in research and competition leading to quality." He added, "Existing years old Ayurveda companies have not contributed much is real research and impetus is highly required despite opposition from few lobbies." ]]> <![CDATA[Worst fears came true says ABLE-AG citing IB report]]> https://biospectrumindia.com/news/95/3325/worst-fears-came-true-says-able-ag-citing-ib-report.html https://biospectrumindia.com/news/95/3325/worst-fears-came-true-says-able-ag-citing-ib-report.html Mon, 23 Jun 2014 16:24:26 +0530 As per ABLE-AG, "The IB report appropriately and comprehensively exposes how few NGOs are active against the economic, social, developmental interests of India." The Association also lauded the subsequent action by Ministry of Home Affairs of the government of India, to put on hold foreign funding of some NGOs as these funds are reportedly being used for surreptitious motives. The report, said ABLE-AG, further highlights how these NGOs have diligently worked towards derailing the diffusion of progressive crop biotechnology in India, which has seen benefits with millions of farmers across the globe. "Our crop yields and animal productivity are one of the lowest globally. Blending modern tools of biotechnology with conventional breeding is essential to produce the required food, fodder, fiber and fuel per unit land area. Technology introduction of genetic modification in crops should be evaluated in the context of crops and traits in which traditional methods have reduced crop improvements or would take too long to develop. Biotech applications in agriculture may be used not in isolation but as a part of the package of solutions to address economic and social needs of a growing population," said Mr Ram Kaundinya, chairman, ABLE-AG."It is a pity that just when the country was about to take further steps in deploying biotechnology in more crops, the unfortunate moratorium on Bt Brinjal was imposed in 2010, under pressure from the same NGOs," he added. As a result, R&D activities in GM crops by both public and private sectors were put on hold since 2010, causing enormous delay in making these technologies available to farmers. There are over 50 applications for initiating biotech research and field trials of various biotech enabled crops pending with the GEAC. At stake is over Rs 8,000 crore, invested in research in the sector by public sector institutions over the past five years. The private sector which is being increasingly maligned is investing about Rs 2,700 crore a year into research. This research is being conducted by Indian researchers, in India, for the Indian farmer. "We urge the Narendra Modi government to ensure that the process of research including open-field trials under the supervision of existing regulatory bodies is not get halted. Field trials are part of research to ensure that the data generated helps scientifically evaluate bio-safety, food safety and the efficacy of the genetically modified seeds, and any attempt to discourage such tests conducted under strict supervision of the regulators is a retrograde step," Mr Kaundinya added. ABLE-AG strongly advocates adoption of biotechnology for the benefit of farmers and food security of the country. The government needs to take all possible measures for fearless promotion of suitable technologies that will help the nation develop in different spheres of economy. Many traits like Water Use Efficiency, Salt Tolerance and Nitrogen Use Efficiency in addition to Insect Resistance and Herbicide Tolerance are waiting to be deregulated so that the country can derisk the lives of millions of farmers. India's population is expected to reach 1.5 billion by 2025 and additional food is needed. Crop improvement, solely by conventional methods to enhance food production by 2050 would be inadequate. Crop losses due to climatic conditions, pests, diseases and declining soil fertility, should be additionally factored in. ABLE-AG strongly refutes the allegations of the four NGOs that the corporates influenced the IB report and dismisses them with utmost contempt that they deserve. This kind of malicious propaganda is aimed at tarnishing the image of premier Institutions like the IB. ]]> <![CDATA[ '2014 Global Economy Prize' for Dr Kiran Mazumdar-Shaw]]> https://biospectrumindia.com/news/95/3376/-2014-global-economy-prize-for-dr-kiran-mazumdar-shaw.html https://biospectrumindia.com/news/95/3376/-2014-global-economy-prize-for-dr-kiran-mazumdar-shaw.html Mon, 23 Jun 2014 16:17:00 +0530 Dr Kiran now becomes the first Indian woman and the fourth Indian to be conferred this prize. The previous honorees include Dr Amartya Sen, Nobel laureate in Economics (2007); Mr Baba N Kalyani, Chairman of Kalyani Group (2009); and Mr Sunil Bharti Mittal, Chairman of Bharti Group (2009). Accepting the award from Prof. Dennis Snower, president, Kiel Institute for the World Economy, Dr Kiran Mazumdar-Shaw said, "I am honored to receive this prestigious award and consider it a great privilege to be in the company of great economists, world leaders and entrepreneurs." Ms Mazumdar-Shaw pioneered biotechnology in India and started Biocon as a novel enzymes company, which has evolved into India's largest biopharmaceutical enterprise. The Kiel Institute for the World Economy is an international center for research in global economic affairs, economic policy consulting and economic education. This prestigious award, established in 2005 by the Kiel Institute, is bestowed upon individuals who have been pioneers in finding solutions to global economic problems by strongly influencing and implementing economic or trade systems based on individual initiative and responsibility. This annual prize is awarded to three individuals: A high ranking policy maker, a renowned economist and an outstanding entrepreneur. The winners this year include: Politics: H E Madam Ellen Johnson-Sirleaf, President of Liberia Economic Sciences: Prof Richard H Thaler, the University of Chicago Business: Dr Kiran Mazumdar-Shaw, CMD, Biocon, India With this award, Dr Mazumdar-Shaw joins an elite list that includes Gro Harlem Brundtland, Norway's former Prime Minister; Mary Robinson, former President of Ireland; Joseph E Stiglitz, Nobel laureate in Economics; Paul R Krugman, Nobel laureate in Economics; Pascal Lamy, former Director General of the World Trade Organization; Jean-Claude Trichet, former President of the European Central Bank; and Dietmar Hopp, Founder of SAP. Mr Sigmar Gabriel, German Vice Chancellor and Minister for Economic affairs, delivered the keynote address at the ceremony, which was attended by distinguished personalities from politics, academia, business and civil society. ]]> <![CDATA[A big day for BIG grantees!]]> https://biospectrumindia.com/news/95/7920/a-big-day-for-big-grantees.html https://biospectrumindia.com/news/95/7920/a-big-day-for-big-grantees.html Mon, 23 Jun 2014 14:42:35 +0530 As part of this plan, BIRAC has introduced the Biotechnology Ignition Grant (BIG) scheme, designed to stimulate research discoveries by providing grants for further development and maturation of these discoveries. Unfortunately, as far as BIG applicants are concerned, access to high-end infrastructure, expert-level guidance, and cutting-edge technology would be inaccessible or prove to be an expensive ordeal or even an unaffordable task. Officially, C-CAMP (Centre for Cellular and Molecular Platforms) has been chosen as one of the three BIG Partner organizations by DBT, to nurture innovation and inventions, which are at an embryonic stage, to reach their proof of concept (PoC) level. As a final culmination on June 18, 2014, C-CAMP saw the first graduating batch of six of the BIG grantees namely: Achira Labs, Codon Biosciences, Pandorum Technologies, Sea6 Energy, Vikas Mehra & Team, and Western Range Biopharmaceuticals. The event took place at the C-CAMP venue at GKVK campus in Bangalore. The grantees gave an individual, 15-minute presentation on their works based on scientific depth and IP strategy, differentiator and competitive advantage, commercialization prospects, market strategy and business model and funding. Talking exclusively to BioSpectrum, Dr Taslimarif Saiyed, COO and director, C-CAMP, said, "The idea behind this is the celebration of exciting innovations and ideas by start-ups. Through this, C-CAMP and BIRAC were able to team up, creating an opportunity for mentoring these start-ups. This enabled us to discuss many interesting ideas to reach the proof of concept stage and to further come closer to much more tangible reality. At C-CAMP we continue to support, foster and nurture such ideas at an early level." One of the graduating companies, Pandorum Technologies' chairman, Dr Tuhin Bhowmick commented, "C-CAMP has been our partner and incubator for the past one-and-half years. My whole team is from IISc. The infrastructure and facilities at C-CAMP has been excellent. But raising our funds was a big challenge." Prior to the day, the BIG grantees met with Biocon's CMD, Dr Kiran Mazumdar-Shaw in a session called, 'Dining with Czars', making a short, 5-minute presentation on their respective work in Electronic City, Bangalore. ]]> <![CDATA[Govt to establish agriculture institutes in each NE state]]> https://biospectrumindia.com/news/95/1368/govt-to-establish-agriculture-institutes-in-each-ne-state.html https://biospectrumindia.com/news/95/1368/govt-to-establish-agriculture-institutes-in-each-ne-state.html Fri, 20 Jun 2014 16:49:11 +0530 Agriculture ministry will look into the special requirements of agricultural education and research in the North-Eastern states. This assurance was given by agriculture minister, Mr Radha Mohan Singh to Mr Kiren Rijiju, MOS (Home) who gave a memorandum highlighting the requirements of the North-Eastern region in the area of agricultural education and research. The minister has directed ICAR to look at the feasibility of opening more agricultural, veterinary colleges and universities in all the eight States of the region. New institutions will be opened, keeping in view the needs of local farmers and also on matters which have high potential in this region. Agricultural education and research play a big role in various ways, such as bringing in latest technology, skill upgradation, and taking scientific know-how to farmers. There is already a Central Agriculture University(CAU) at Imphal, and it is being felt that the CAU needs to be strengthened and new university and colleges need to be opened in different States to cater to the veterinary, horticulture, food processing and other specialised areas. ]]> <![CDATA[Budget 2014: Overhaul of biotech industry a necessity]]> https://biospectrumindia.com/news/95/5976/budget-2014-overhaul-of-biotech-industry-a-necessity.html https://biospectrumindia.com/news/95/5976/budget-2014-overhaul-of-biotech-industry-a-necessity.html Fri, 20 Jun 2014 16:45:00 +0530 The Association of Biotechnology Led Enterprises (ABLE) terms the bioscience industry as the most regulated, least incentivized, under invested and irrationally taxed sector in India. This, according to it, puts a serious strain on providing affordable health care with quality and innovative medicines for Indians and in attaining a global leadership position. It has the potential to be a S100 billion (Rs 6 lakh crores) industry in the next decade. Therefore, the leading association has urged the government to consider an overhaul of the Pharma-Biotech sector as it is the need of the hour. Perception and credibility of this sector have been completely eroded due to several factors in the past few years. "We strongly recommend a transparent regulatory framework, bio-manufacturing infrastructure, investment in R&D and a very rational tax structure. India has all the ingredients to become a global leader in affordable healthcare. With all the support, we as a nation can attain global leadership in providing affordable health care and innovative medicines, quality food and feed for all" remarked Dr P M Murali, president, ABLE. Here are the key recommendations made by ABLE to the government: â– Make Bio-manufacturing the next big opportunity after generics for India. Invest $4-5 billion each year (Rs 24,000 to 30,000 crores) in the next 5 years to grow the Biotech Industry to $100 billion by 2025 with a 25 percent return on investment and set a growth rate of 30 percent year on year. â– Allocate Rs 500 crore each year from the R&D cess accessible by the Technology Development Board to stimulate the biotech sector across the range: from Human Resource Development, high-end institutional development in Biotech, stimulating incubators, ignition grants, start-ups and small businesses, and collaborative efforts in cutting-edge technologies with business of all sizes on one hand and national and international academia on the other. â– Corporate Social Responsibility (CSR) funds may be used for stimulating public-good and socially-relevant research in collaboration through partnership with the Biotechnology Industry Research Assistance Council (BIRAC) of the Department of Biotechnology (DBT). All such contributions to BIRAC should be fully-tax exempt. As of now, only incubators in academic institutions are eligible for availing CSR funds for promoting innovation. This was passed as a GO last year. This should be extended to all incubators and science/ biotech/ knowledge parks, whether they are a part of academic institutions or not. â– The Department of Biotechnology be allotted an additional Rs 50 crores a year to further stimulate and develop the International Centre for Genetic Engineering and Biotechnology (ICGEB) into an India-led hub for high-end application oriented research in lifesciences and biotechnology, with international partnerships stretching from Africa and West Asia to Japan and the Pacific. â– Service tax for the CRO industry is putting Indian companies at a significant disadvantage over some of our neighbours and competitors. We request elimination or substantial reduction in the service tax, especially for overseas clients paying in foreign currency. â– Weighted tax deductions should be applicable to outsourced clinical trials and R&D, preparations of dossiers, foreign consulting/ legal fees for NCE (New Chemicals Entities) and ANDA (Abbreviated New Drug Applications) filings with the US FDA and Patent defending charges. â– Encourage setting up of venture capital funds focused on investments in biotechnology, all contributions by Indian Corporate including Pharma companies to SEBI registered Biotechnology funds should be eligible for the weighted average tax deduction under Section 35 (2AB). ]]> <![CDATA[ABLE pushes for Biotech Exports Promotion Council]]> https://biospectrumindia.com/news/95/1338/able-pushes-for-biotech-exports-promotion-council.html https://biospectrumindia.com/news/95/1338/able-pushes-for-biotech-exports-promotion-council.html Fri, 20 Jun 2014 16:40:39 +0530 Keeping in view the importance of biotechnology products, their diverse nature, different regulatory environment and trade dynamics as well as India's growing competencies in this field, ABLE has suggested that a Biotech Exports Promotion Council be set up. According to the leading Association, the proposed Council should be allocated a corpus of 100 crores and its main aim will be to Promote India as a preferred source for Biotech products and services. This would be possible by investing in brand building and promotions since both activities are necessary drivers for not only promotion but for also countering any negative publicity. The Council could also hold seminars on important issues of quality control, manufacturing, trade barriers and advise the government on policy matters and also help in resolving international issues that need technical inputs. As per ABLE, it has been playing a similar role for the past 10 years and can help in setting up the Council and participate as the private sector representative. ]]> <![CDATA[Fortis pioneers new minimal invasive surgery]]> https://biospectrumindia.com/news/95/5731/fortis-pioneers-new-minimal-invasive-surgery.html https://biospectrumindia.com/news/95/5731/fortis-pioneers-new-minimal-invasive-surgery.html Thu, 19 Jun 2014 18:02:00 +0530 In a press conference announcing a second successful experimental minimally invasive cardiovascular bypass surgery, Dr Vivek Jawali, chairman, Cardiovascular sciences, Fortis hospital, spoke about the benefits of the surgery and collaborations with doctors across the world. Pioneers in minimal invasive surgery, Drs Jawali and Murali Manohar, with a number of surgeries under their belt, were heading the team with Dr Manohar taking the lead. The operation was on a 46-year-old woman, Mrs Seema Bai of Bidar. The bypass surgery, which is done through the abdomen, for the first time in 1995, in the Austral Asia region and in the country, was performed by the same team. Talking about the benefits of the surgery, Dr Jawali said, "The major advantage of a minimal invasive surgery is that there is no breakage of bone. This reduces the recovery time and the amount of blood loss dramatically. It benefits the patients cosmetically as well as there is little to no scarring." Talking about partnerships, he said that China has a number of cases wherein the procedure was used successfully. He also mentioned that they were in conversation with a number of fellow surgeons about the surgery and the need to highlight it. Minimal invasive surgery has been in existence for sometime, with a successful surgery done in India way back in 2005. In this procedure, the cut is made in the abdomen where the soft tissue makes it easier to stretch and insert required equipment into the chest cavity. This procedure leaves the sternum intact which is great news for people with diabeties, whooping cough and others who need substantial time to heal. The costs of the surgery will remain the same as the normal heart bypass. Though the surgery has yet to gain prominence in India, Drs believe it is only a matter of time before a number of fellow doctors embrace it. ]]> <![CDATA[Can product pipeline innovation combat antibiotic resistance?]]> https://biospectrumindia.com/features/95/5844/can-product-pipeline-innovation-combat-antibiotic-resistance.html https://biospectrumindia.com/features/95/5844/can-product-pipeline-innovation-combat-antibiotic-resistance.html Thu, 19 Jun 2014 17:42:00 +0530 For combating antimicrobial resistance (AMR), the biotech and the biopharmaceutical companies have to innovate better therapeutic tools to fight back the drug resistance. Especially, pharma companies should have new and improved drug pipeline to stay prepared for any outbreaks. Companies can consider partnering with research-based organizations and other science promoting agencies, and to actively work towards promoting public health awareness, and rational prescription of antibiotics by physicians. Antimicrobial resistance occurs when microorganisms such as bacteria, viruses, fungi and parasites change in ways that renders the medications ineffective. Faulty Practices 'Antimicrobial resistance' is the broader term for resistance in different types of microorganisms, and encompasses resistance to antibacterial, antiviral, antiparasitic and antifungal drugs. "When microorganisms become resistant to most antimicrobials, they are often referred to as 'superbugs' in nontechnical terms. This is a major concern because a resistant infection can kill, spread to others, and impose huge costs on individuals and society by prolonging the disease and forcing the use of expensive drugs," says Dr Poonam Khetrapal Singh, WHO Regional Director for South-East Asia. Faulty practices and flawed assumptions have clearly made the inevitable development of drug resistance happen much sooner, rather than later. For some diseases, like malaria, the options are very limited as currently there are only a single class of effective drugs with which to treat more than 200 million falciparum cases each year. Developing New Drugs Although new drugs are under development, especially through the Medicines for Malaria Venture, a public-private partnership, early signals of artemisinin resistance have already been detected. Developing new antibiotics is an expensive exercise for drug companies. With continued irrational use of antibiotics, new drugs can also become ineffective fast. With this risk in view, perhaps it is time to develop new business models to encourage investment of new products. Antimicrobial resistance occurs spontaneously in pathogens but can also be exacerbated by the inappropriate use of medicines, for example, when taking substandard doses or not finishing a prescribed course of treatment. Low-quality medicines, wrong prescriptions and poor infection prevention and control also encourage the development and spread of drug resistance. "Poor surveillance to produce evidence-based treatment guidelines, inability to understand magnitude and trend of resistance, and a diminishing arsenal of tools to diagnose, treat and prevent, also hinder the prevention and control of antimicrobial drug resistance," explains Dr Poonam Singh. Antibiotic resistance is particularly pressing in developing nations, including India, where the burden of infectious disease is high and healthcare spending is low. "The bacterial disease burden in India is among the highest in the world. Consequently, antibiotics will play a critical role in limiting morbidity and mortality in the country. Antibiotic use has been increasing steadily in recent years, and policy makers have been regularly briefed about the growing public health concern regarding antimicrobial resistance (AMR), the National Antibiotic Policy and further evolution of AMR surveillance in India," elucidates Dr Nata Menabde, WHO Representative to India. Several serious steps have been taken in the past to combat AMR. In 2011, India was signatory to the Jaipur Declaration on Antimicrobial Resistance, signed off by Health Ministers of the WHO South-East Asia Region. The Combat Combating the problem of antimicrobial resistance (AMR) warrants concerted efforts at national and international levels to preserve the available antimicrobial agents. An effective response to antimicrobial resistance is possible through treatment policies such as combination therapy, rational prescription, patient adherence, strong regulatory mechanism and educational activities along with an efficient surveillance system. According to Dr Poonam, WHO has been advocating actions at national level to contain AMR for the last several years. "Global policy package on AMR was launched by WHO in 2011. To facilitate activities to combat AMR at the country level, the WHO Regional Office for South East Asia has developed a simple and practical strategy that aims to give particular attention to interventions involving the introduction of legislation and policies governing the use of antimicrobial agents, establishing laboratory-based network of surveillance of AMR and ensuring rational use of drugs at all levels of health care setting," comments Dr Poonam. Currently, WHO is providing technical support in scaling up implementation of the regional strategy on AMR which is also in line with the Jaipur Declaration on AMR. Other Countries Member states across the globe have also requested WHO to take lead and develop a global action plan on AMR. WHO shall be working on preparation of global action plan soon in collaboration with partners and stakeholders. At this point in time, there is a clear need for concerted action from all concerned. Given the cross-cutting nature and complexity of the problem, it is essential that every stakeholder has clarity about its role in combating this menace both within its own mandate as well as for the issues that have bearing upon activities of other sectors. Other countries have also paid significant attention to the rising issue of AMR and have agreed to work under WHO's guidance by bringing all stakeholders together to agree on and work towards a coordinated response; strengthening national stewardship and plans to tackle AMR; generating policy guidance, and providing technical support for Member States; and actively encouraging innovation, research and development. Tackling Drug Resistance Effective surveillance of antimicrobial resistance and use is a pre-requisite for effective prevention and containment of antimicrobial resistance. The health ministers of WHO South-East Asia Region committed to combating drug resistance in the Jaipur Declaration. Since then, there has been growing awareness of the need for appropriate tracking of drug resistance, and all countries have agreed to contribute information to a regional database, which is coordinated by WHO. "It is important to have national alliance and national policy for antimicrobial resistance. A strong regulatory mechanism to make drugs accessible, and ensuring quality drugs, is an important step towards curbing this menace. It is also important to regulate the use of antibiotics in sectors like animal husbandry," opines Dr Poonam. Collaboration and Awareness Countries must build their capacity to generate reliable data on the magnitude and trend of resistance by establishing national networks of laboratory-based surveillance, improving quality of prescriptions and infection prevention and control at health care facilities. Dr Poonam also emphasizes on educating communities about prescription compliance, risks of self-prescription and awareness of the spread of AMR and its consequences. "Innovations in drugs, diagnostics, infection prevention and control, and treatment are also needed," she says. Collaboration between human and animal health and agriculture professionals is vital, as the use of antibiotics in food animal production contributes to increased drug resistance. Approximately half of current antibiotic production is used in agriculture, to promote growth and prevent disease as well as to treat sick animals. With such massive use, those drug resistant microbes generated in animals can be later transferred to humans. The Task Force A Task Force was constituted by the Indian government to recommend measures to address the problem of multi drugs resistance arising out of widespread and indiscriminate use of antimicrobial drugs in the country, and to assess, review and suggest measures on anti-microbial resistance. The Task Force recommended various steps to rationalize the use of antibiotics in the country. Action points taken towards addressing AMR: â€¢ Planning Commission has approved the 12th Five Year Plan, where AMR has been approved as a new programme â€¢ The Union Health Minister has been actively participating in the visits related to Indo-Swedish partnership on AMRâ€¢ India has participated in two global meetings on Drug resistant TB at WHO HQ: Global Drug Resistant TB initiative and Global Laboratory Initiative â€¢ A national workshop on developing guidelines for Drug Susceptibility Guided Treatment for TB is scheduled in June 2014 â€¢ The WHO Country Office for India recently concluded a review of the National Vector Borne Disease Control Programme (March 2014), with active participation from senior policymakers where concerns of drug resistant malaria were discussed â€¢ Under the Drugs & Cosmetics Rules, drugs specified under Schedule H and Schedule X are required to be sold by retail on the prescription of a Registered Medical Practitioner only. Recently, a new Schedule H1 has been introduced through Gazette notification GSR 588 (E) dated 30-08-2013, which contain certain 3rd and 4th generation antibiotics, certain habit forming drugs and anti-TB drugs ]]> <![CDATA[US FDA warns Apotex's Indian facility]]> https://biospectrumindia.com/news/95/4023/us-fda-warns-apotexs-indian-facility.html https://biospectrumindia.com/news/95/4023/us-fda-warns-apotexs-indian-facility.html Thu, 19 Jun 2014 17:09:39 +0530 United States Federal Drug Approval (USFDA) has issued a letter to the COO of Apotex Mr Jeremy B Desai. Th letter was issued after investigators identified significant deviations from current good manufacturing practice (CGMP) for the manufacture of active pharmaceutical ingredients (APIs) in the company's Bangalore plant. In the report, the regulatory has said that the company failed to maintain complete data, derived from laboratory tests conducted. The tests need to comply with established specifications and standards. It asked the company to provide a list of all the batches of APIs in distribution and those intended to be shipped to the US market that relied upon "the missing, inaccurate, or unreliable test data". The FDA said that it may withhold approval of any new applications or supplements listing it as an API manufacturer until the regulatiory body has confirmed that all corrections of the deviations have been carried out. It further warned that failure to correct these deviations may result in FDA continuing to refuse admission of drugs manufactured at Apotex Pharmachem India. The company has 15 working days to notify FDA of the specific steps that the company has taken to correct and prevent the recurrence of deviations, and provide copies of supporting documentation. ]]> <![CDATA['Novartis focuses on new products, business growth']]> https://biospectrumindia.com/news/95/7769/novartis-focuses-on-new-products-business-growth.html https://biospectrumindia.com/news/95/7769/novartis-focuses-on-new-products-business-growth.html Thu, 19 Jun 2014 17:01:44 +0530 Novartis India has over the past year launched three successful patented drugs and over 12 generic drugs. They have helped it expand its presence in the country. "Glivec is behind us. Strategically, all products which are in Novartis pipeline and also make it to the commercial case will be launched in India," said Mr Ranjit Shahani, vice chairman and managing director of Novartis India. The pharma major which acquired UK drug maker Glaxo Smithkline early this year, plans to float a joint venture to sell over-the-counter drugs. It may also launch some of GSK's products in India. "Effectively, we will launch any product which cover an unmet medical need and regulatory approval is given," Mr Shahani said. Novartis has maintained that it will not indulge in full-fledged pharma research in India, it has invested in building a global centre in Hyderabad to cater to drug development of its parent firm. The company remained sceptical about the pricing pressure that pharma companies are facing. India is by far the lowest priced country in the world for medicines, but psychologically, pharma industry remains the favourite whipping boy, Mr Shahani said, adding, "We need to look at price cuts logically and dispassionately. My question is why should the rich pay the same price as the poor, for the same drug ? There should be cross-subsidy between the rich and the poor." ]]> <![CDATA[Dr Reddy's launches Melgain lotion for vitiligo]]> https://biospectrumindia.com/news/95/8414/dr-reddys-launches-melgain-lotion-for-vitiligo.html https://biospectrumindia.com/news/95/8414/dr-reddys-launches-melgain-lotion-for-vitiligo.html Wed, 18 Jun 2014 17:39:55 +0530 Pharma giant Dr Reddy's Laboratories launched Melgain lotion, in-licensed with city-based Issar Pharmaceuticals for the domestic market. It is said to be the first peptide-based drug for vitiligo. While Issar will be manufacturing the product, Dr Reddy's will take care of marketing. Vitiligo is a skin disease that leads to white patches on the body due to the loss of the normal skin pigment, melanin. About five crore people in India are affected by this skin disorder. "As white patches are more obvious on generally dark Indian skin, the condition causes social stigma," Dr Reddy's Laboratories' senior vice president and India business head (generics) Mr Alok Sonig said, citing reports suggesting that around 54 percent vitiligo patients, in India, were found to be suffering from depression. Speaking about the product, Mr Sonig said, "Melgain lotion leads to re-pigmentation in 80 percent to 90 percent of patients, as compared to the 60 percent who respond to other medical treatments such as corticosteroids and phototherapy". He added, "Melgain lotion is safe and efficacious for usage on various parts of the body, as established by a number of clinical studies. Its safety is well established for treating children as well." "Studies have also shown that patients respond faster when Melgain lotion is used in combination with other medical treatment options," he further added. He also pointed out that the company was working towards strengthening its dermatology products portfolio and is eyeing a slot in the top five players of the segment in India in the next five to seven years. The dermatology segment currently contributes less than 10 percent of the revenue. ]]> <![CDATA['Indian biotech sector needs Rs 30,000 crore p.a.']]> https://biospectrumindia.com/news/95/5749/indian-biotech-sector-needs-rs-30000-crore-p-a-.html https://biospectrumindia.com/news/95/5749/indian-biotech-sector-needs-rs-30000-crore-p-a-.html Tue, 17 Jun 2014 17:56:48 +0530 "Biotechnology and lifesciences industries need a road map of growth, opportunity and fiscal responsibility for bio-economy. We strongly recommend transparent regulatory framework, bio-manufacturing infrastructure, investment in R&D and a very rational tax structure," ABLE President PM Murali said. To provide affordable healthcare with innovative medicines and attain global leadership in R&D, India needs an investment of Rs 30,000 crore annually in the next five years so that the biotech industry can grow to $100 billion by 2025, say industry experts. "With all the support, we as a nation can attain global leadership in providing affordable health care and innovative medicines, quality food and feed for all," he added. ABLE also recommended allocation of Rs 500 crore each year from R&D accessible by the Technology Development Board to stimulate the biotech sector, which includes human resource development, high end institutional development in biotech, stimulating incubators, ignition grants, start-ups and small businesses. ABLE also recommended that there should be a mandate that only India-manufactured drug products be eligible for weighed premium and tenders. ]]> <![CDATA[Indo-Dutch collaborative project in plant research]]> https://biospectrumindia.com/news/95/3821/indo-dutch-collaborative-project-in-plant-research.html https://biospectrumindia.com/news/95/3821/indo-dutch-collaborative-project-in-plant-research.html Tue, 17 Jun 2014 17:50:58 +0530 The aim of the call for proposals is to stimulate sustainable Indo-Dutch research collaboration by funding joint research projects on the topic "Plant sciences creating societal and commercial perspective towards crops with improved tolerance to heat and droughtâ€Ÿ. The call will be implemented by the DBT, government of India and by the Earth and Life Sciences department (ALW) of NWO. The program offers funding opportunities for bilateral research co-operation between Dutch and Indian research groups. The call for proposals, is valid until the closing date September 4, 2014. The call budget covers funding for a maximum of three joint bilateral projects, jointly funded by DBT and NWO. A project allows for the application of four PhD or post-doc positions: two in India (duration and fellowship amount as per terms and conditions of DBT) and two in The Netherlands (duration and fellowship amount as per terms and conditions of NWO, including terms contained in this brochure and website). On the Dutch side, a maximum budget of â‚¬466,500 per project can be applied for. DBT will provide matching funds to Indian scientists. Both countries have a strong history in plant research. This program will contribute to the further enhancement of bilateral innovative research that is aimed at solutions for challenges the current and future society faces. Projects should contribute and foster the collaboration between the best research institutes or groups in both countries ]]> <![CDATA[Arvind Remedies signed MoU to launch new drugs]]> https://biospectrumindia.com/news/95/5699/arvind-remedies-signed-mou-to-launch-new-drugs.html https://biospectrumindia.com/news/95/5699/arvind-remedies-signed-mou-to-launch-new-drugs.html Tue, 17 Jun 2014 15:52:57 +0530 Arvind Remedies, a producer of branded and generic pharma products has entered into a Memorandum of Understanding (MoU) with Adesh University, Bhatinda, Punjab. As per the understanding, The company aquires rights for the patents the institute holds. The company will undertake exclusive manufacturing, marketing and commercialisation of drugs for Type II diabetes, depression, irritable bowel syndrome (IBS) and coronary heart disease. Dr B Arvind Shah, MD and CEO, Arvind Remedies said, "According to the International Diabetes Federation, 382 million people across the world have diabetes, which is expected to rise to 592 million by 2035. The number of people with type II diabetes is increasing in every country. In order to curb this disease, we have come up with a new drug that was derived from a botanical source which ensures zero side effects on the health of the patient. We are expecting this new drug to be available in the markets by mid-2015." He further added, "Coronary heart disease is also the most common type of heart disease and is killing more than 385,000 people annually. We are happy to announce that we have been successful in developing a new drug, which will help in the treatment of coronary heart disease." The drugs will be manufactured in the form of tablets and will be launched in the domestic market by 2017, followed by the global market, the company informed. ]]> <![CDATA[New government: India's leading biotech voices speak]]> https://biospectrumindia.com/features/95/6244/new-government-indias-leading-biotech-voices-speak.html https://biospectrumindia.com/features/95/6244/new-government-indias-leading-biotech-voices-speak.html Tue, 17 Jun 2014 12:27:00 +0530 With the new government in place in the country now, expectations are soaring high across various industry segments. Industry experts and stalwarts are keeping a keen watch on every move the new government is making to keep its promises. The nation's Biotechnology sector, neither, is an exception. With unresolved and long-pending turmoil and hurdles over regulations, investments, and clinical trials, the industry is fully geared, pinning its hope on the new government. But then, there are industrialists who believe that the government alone cannot solve the industry's crises. According to Dr G S Krishnan, regional president-India, Novozymes South Asia, areas like regulatory, biodiversity and environmental concerns require serious fillip and revamp to witness giant leaps in business opportunities. "The Industry needs decision makers to support the industry's development with faster approval process, if we have to be on par with the other developing world. It is definitely BT after the IT boom, which will also be the key to India's economic growth which is far more sustainable," he added. This new government is also expected to prioritize overall support to the biotech segment helping India compete with the global markets by playing a leadership role. Dr Krishnan also opined that the government can play a pivotal role in supporting key traditional polluting industries for faster adoption of sustainable biotech solutions and by enforcing environment regulations which are already in place, thereby sustaining the economy in the long run. "It is also imperative that a special committee is set up to address biofuel segment development in the interest of reducing dependence through oil imports in line with the rest of the world, and reducing our current account deficit significantly. We can take advantage of the abundant agricultural residues available in this country. They can be put to better use and evolve a policy which will support inclusive growth, supporting farmers and also generate employment in rural areas," he commented. Then there are others who want reduced interest rates on borrowed capital, creating a climate for investment in the segment. Said Dr Ajay Bhardwaj, CEO, Anthem Biosciences, "It is important to remove the stigma of India being a difficult place for getting simple things done. Also, reduction in rampant corruption in government agencies is crucial for development. In fact, it is a daunting task to deal with government. Making land and buildings reserved for biotechnology industries at affordable rates is much needed. The lobbying ability of Biotechnology enterprises with the government is limited. We are still at the margins. ABLE needs to get more diversified and professional to take up the challenge of representing this nascent industry." Dr Bhardwaj also wants the new government to treat investments in biotech on par with the IT sector. "The IT sector has innumerable duties and tax exemptions compared to biotech. It is important to open doors for international investments in biotechnology. This technology has to be embraced and not feared. However, misguided and misinformed NGOs hold too much sway over policy," he commented. Post election results, on May 17, 2014, Dr Kiran Mazumdar-Shaw, CMD, Biocon, in her blog, under the title, 'Reviving the Indian Growth Story', wrote, "If the new government is serious about delivering on its promise of a better life for every single Indian, its No. 1 priority should be to navigate the country towards a path of sustainable and inclusive economic growth. The new government that comes to power will have to move quickly to de-bottleneck projects and revive investment sentiment in the country. India desperately needs to be seen taking corrective actions to regain its lost glory by creating an enabling ecosystem that paves the way for a double digit growth." According to her, the new government needs to take critical steps to revive the Indian economy through smarter regulations for ease of doing business, efficient taxation system, removing bottlenecks for boosting the flow of foreign capital, generating high-skilled jobs, introduction of universal healthcare program and focusing on science and technology, and incentivizing innovation. Dr Mazumdar-Shaw also wrote, "There is no scope for complacency as significant challenges face the country. Projects worth over $100 billion were shelved or abandoned in FY14, the highest in the past 18 years, due to policy uncertainty and pending regulatory clearances, according to CMIE." Avesthagen's founder and CMD, Dr Villoo Morawala Patell, sums up her expectations in just one line. "It is funding, funding and funding, and allowing R&D companies to list on the stock market." For some of them, the existing confusion over clinical trials regulation in the country seems to be a mammoth burden that the new government mandatorily needs to solve immediately. Dr Jagadish Mittur, head, Biotech Facilitation Cell in KBITS, Department of IT, BT and S&T, Government of Karnataka, expressed, "We need an atmosphere of fearlessness in supporting innovation and creativity. Lack of large capitals and coordination in prioritized research need to be addressed quickly by the new government. There should also be accountability in place on research spending. Most of all, the commotion over the requirement of GM technologies to solve India's hunger, malnourishment and farmers issue has to be resolved." Hyderabad-based Indian Immunologicals' deputy managing director Dr K Anand Kumar said that streamlining the regulatory approval process for vaccines is crucial, since the current situation takes four long years for human vaccine approvals and six years for veterinary vaccines. He sees clearing infrastructure bottlenecks, especially the lack of power availability as an important part of manufacturing vaccines. "Ironically, life-saving vaccine units face power cuts in Andhra Pradesh, whereas IT companies are exempt," he lamented. "The new government has to simplify the approval process for clinical trials without compromising on quality, safety and efficacy. Countries like the US and the UK have a separate regulatory body for veterinary products. India should adopt that. It is significant to provide incentives for both research and capital investments in the biotechnology sector," concluded Dr Kumar. Dr V S Ravindran, CEO, Caprienzymes, strongly feels that the younger generation need to be given the right platform for the growth of the industry. "Young-blooded entrepreneurs and start-ups in the country should be provided the right physical space in technology parks at subsidized rates. The new government needs to realize the importance of technology transfer and joint ventures along with industrial partnerships with academia and institutions. R&D activities desperately need support and transparency. In India, marine biotechnology needs much more attention, and the usage of chemical pesticides should be substituted by organic fertilizers and manures." For many experts in the industry, 'regulation' seems to be on top of the mind which requires immediate attention.According to Ms Mahima Datla, the currently regulation related to new drugs is fragmented and spread across many ministries. "A restructuring of the CDSCO along with a consolidation between regulations related to food, GMO's and drugs needs to be seriously contemplated. There are many successful examples of this structure in most parts of the world. Building technical competence within such a consolidated structure would be equally important," she adds. She also feels that another issue that needs more immediate attention is clinical trials. "Clinical research is an absolutely critical step in the process of validating new drugs efficacy and safety and as such initiatives that raise the bar in terms of improving the quality of clinical research being conducted is welcome. At the same time, it is imperative that regulation in this area be streamlined and be formed in the context of encouraging innovation to occur. Our current regulations are counter-productive, not just for innovation but for affordability and access," says Ms Datla. In the specific context of immunization, Ms Datla emphasizes the need to build on the success the country has demonstrated in Polio control, and focus on increasing the coverage of existing vaccines, and ensuring that children do not die from vaccine preventable diseases. "Increasing the spend on health and reversing the alarming trend of reduction in budget allocations for immunization will need to be addressed in order to strengthen health systems and delivery and reduce childhood mortality," Ms Datla opines. Some countries benefit from the fact that they have push-mechanisms, to stimulate innovation. Examples of this is where the governments invest significantly in research and innovation, thus having a robust pipeline emerging from academia and research institutes. "In India, funding of scientific institutions has not translated to innovation and applicable health interventions, and we largely rely on innovation from external scientific institutions or industry," she continues. "Therefore, in the context of our country, mechanisms that generate demand for products and services, healthy policies related to FDI, pricing, and taxation have immediate relevance in stimulating innovation and investments in the biotech industry and these are the ones I hope the new government focuses on in order to facilitate growth." According to Dr Mallik Sundaram, CEO & president, Mitra Biotech, the new government needs to form transparent policies regulations to create a friendly start-up environment to bring path-breaking technologies to the forefront. "It is important to create and retain human capital which would be an asset. And developing a pipeline through premier educational institutions is crucial. It is also imperative to create an ecosystem conducive for funding through grants or investors for research and commercialization," commented Dr Sundaram. He believes that creating a stringent framework to maintain optimal utilization of funds, and accountability by recipients should be made mandatory. "Promoting working with educational institutions to encourage internships and update curriculum with recent advancements, leveraging more public-private partnerships and eliminating unnecessary red-tapism should be considered as pivotal tasks by the new government," ended Dr Sundaram. Speaking for the Agri-biotech industry, Dr K K Narayanan, MD, Metahelix Life Sciences, said, "Regular functioning of GEAC and its sub-committees should be re-initiated. All the back-log of applications for GM crop trials or studies and commercialization should be disposed-off as soon as possible. It is significant to frame a clear policy regarding GM food crops which need to be allowed in the country. Also, the centre-state policy coordination mechanism needs to be made more effective." Dr Narayanan also emphasized that the State-level NOC requirements for conducting field trials needs to be dispensed with. "The BRAI bill needs to be re-introduced after appropriate modifications," he added. He also suggests that the new government initiate and launch a public outreach program to promote the correct understanding of biotechnology in agriculture to dispel misinformation and promote better understanding among the public at large. "The government's subsidy should also be targeted at improving the adoption of new and productivity enhancing technologies that augment farmer's income," Dr Narayanan expressed. "The new government seems to be keen on knowing the challenges, and is already taking measures to interact with all stakeholders. The industry organization, ABLE, can interact with the people concerned and also make formal representations, which I believe is already underway," he concluded. ]]> <![CDATA['CSIR has to rise as a force of development']]> https://biospectrumindia.com/news/95/7762/csir-has-to-rise-as-a-force-of-development.html https://biospectrumindia.com/news/95/7762/csir-has-to-rise-as-a-force-of-development.html Mon, 16 Jun 2014 16:32:12 +0530 "Our country is being positively swept by a current of change, looking beyond a segmented mind set. CSIR cannot be left behind and has to rise to the occasion to align itself with the force of development as a catalyst and front runner. With the clout embedded in its laboratories, CSIR has to achieve its mission and mandate to impact the industrial, societal and environmental sectors to fulfill the aspirations of the people of India," mentioned Dr P S Ahuja, director general, CSIR in his recent message. Dr Ahuja who was earlier the director of the Institute of Himalayan Bioresource Technology (IHBT). During the year 2008-09, he also had additional charge as director, Central Institute of Medicinal & Aromatic Plants (CIMAP), Lucknow. He was the head of the Department of Plant Tissue Culture at CIMAP Lucknow wherein his Department became a Center of Excellence. Thereafter, he joined as head, Plant Biotechnology and Biodiversity Conservation Division, CSIR Complex, Palampur now known as IHBT. "CSIR has proven worth which needs positive projection and realization. For this, a concerted efforts are required both at the laboratory level as well as by the CSIR headquarters. The Industrial Sector also needs to be encouraged by policy and regulation to spur itself in partnership with the R&D potential within the country. We look towards to a forward-looking policy that promotes public-private partnership in R&D domain with a perspective to growth, development and employment generation. The science and technology (S&T) sector, just as any other has been tied down in a morass of constraints and procedures which need to be liberated forthwith. The sector requires an infusion of fresh blood and quality manpower to a much higher extent than the sanctioned strength today," said Dr Ahuja. "Those who are entrenched in scientific pursuits need to rise above themselves and move towards teamwork so as to achieve national goals. It is a time to deliver and stand shoulder to shoulder to rise to the soaring expectations," he concluded. ]]> <![CDATA[ICMR issues guidance on transfer of human biological material ]]> https://biospectrumindia.com/news/95/4656/icmr-issues-guidance-on-transfer-of-human-biological-material-.html https://biospectrumindia.com/news/95/4656/icmr-issues-guidance-on-transfer-of-human-biological-material-.html Mon, 16 Jun 2014 16:28:07 +0530 As per the guidelines issued by the Ministry of Health and Family Welfare, government of India dated November 19, 1997, a Committee has been constituted to consider cases related to the transfer of human biological material for commercial purposes and/or evaluation of cases involving transfer of infectious biological material, human biological waste or other cases for commercial purposes from foreign research centers to Indian diagnostic laboratories or R&D centers or vice versa for analysis. The recent notification from ICMR mentions that about 10 sets of applications including copies of documents are to be submitted by organizations, in English only. The format is available on its website. The release mentions that separate applications should be submitted for import or export of biological samples as per requirement, separate applications should be submitted for transferring samples to or from different countries. A copy of the duly signed Material Transfer Agreement (MTA); Institutional or Independent Ethics Committee (IEC) clearance along with the composition of Ethics committee (if available in a foreign language, should be translated into English); a copy of the patient information sheet and informed consent form (as approved by IEC) giving details on the utilization of samples of the patient for a particular research or R&D study and the kind of benefit (direct/indirect or no benefit - as applicable) for appropriate decision making by the patient (if available in a foreign language, should be translated into English version); a copy of the import certificate as issued by the relevant foreign regulatory authority to the foreign laboratory receiving the Indian biological material (wherein export is concerned); a copy of the Memorandum of Understanding signed between Indian applicant and international agency defining the commercial benefits to each Party and separate copy of the details of the Intellectual Property Rights (if any) owned in terms of patents, copyright or an MoU signed by any of the Parties on the biological or genetic material being transferred for commercial purposes. Also a copy of safety or operations manual being followed or adopted by the laboratory for workers involved in activities involving possible exposure to pathogens through blood or other body fluids; copy of the disposal plan and necessary State pollution Control Board clearance (for disposal of biohazardous, potentially infectious leftover samples); copy of the contract or agreement with the disposal agency that the hazardous leftover bio-material will be collected, treated and disposed off as per current national regulations and a duly valid copy of DCGI approval issued to the study center for conducting Bioavailability/ Bioequivalence/ Pharmacokinetic analysis. A duly valid copy of approval for providing services under relevant disciplines such as diagnostics/ physical - chemical studies/toxicity studies /medical / biological testing etc, as applicable, from either of the following to be enclosed.i) National Accreditation Board for Testing and Calibration Laboratories (NABL) certificate for diagnostic/clinical trial labs or Certificate of GLP compliance /DSIR certification as issued by the Ministry of Science and Technology, GoI in the relevant discipline as applicable. ii) Equivalent approval e.g. from College of American Pathologists (CAP) or any signatory of International Laboratory Accreditation Cooperation Arrangement." The applicants need to submit an undertaking that the material being imported has been tested and free from HIV, Hepatitis B and C, Malaria and Syphilis. For transfer of samples, the Indian applicant should follow the downloadable WHO document 'Guidance on regulations for the transport of Infectious substances (2013-2014)'. There are specific packing instructions as per United Nations class (6.2) specifications to be followed during transport of infectious substances. Unless otherwise declared, the biological materials such as blood and/or blood components; dried blood spots and faecal occult blood; medical or clinical wastes are to be considered under the 'infectious substance category'. The applicants are required to indicate the category under which the infectious substances or organisms fall. In addition to categories indicated as per UN class specifications in WHO guidelines(2013-14), the applicant should also refer to the relevant categories mentioned under Special Chemicals, Organisms, Materials, Equipment and Technologies (SCOMET) items in schedule of India's Foreign Trade Policy classification (downloadable) as well as Animal and Human pathogens scheduled as Risk Groups in the Ministry of Environment and Forests Notification,GoI,1989 (downloadable). Accordingly, the 'category' in terms of infectious nature or risk group of biological substances to be transferred is required to be assigned and indicated by the applicant. Laboratory Biosafety Manual, World Health Organization -2004 (downloadable) should be followed by Indian applicants to implement basic concepts in biological safety and for the safe handling of pathogenic microorganisms in laboratories. The Environment (Protection) Act, 1986 and the rules framed there under (downloadable) should be referred to by the applicants for disposal of biological material after due testing of biological samples is done. ]]> <![CDATA[Cipla and Roche to mediate in patent case]]> https://biospectrumindia.com/news/95/6681/cipla-and-roche-to-mediate-in-patent-case.html https://biospectrumindia.com/news/95/6681/cipla-and-roche-to-mediate-in-patent-case.html Mon, 16 Jun 2014 16:16:41 +0530 After fighting a long and bitter patent battle in India, Swiss innovator firm Hoffman La Roche and Indian generic drug maker Cipla hope to settle the matter on mutually agreeable terms. The Delhi high Court has ordered the Pharma majors to mediate and settle terms, according to reports. Roche accused Cipla of infringing on its patent for lung cancer drug Tarceva, which Cipla sells under the brand name Erlocip. This is also the first patent suite in the country to have been referred for mediation by the court. The two companies have been fighting a legal battle over Roche's patent for years. In September 2012, an Indian court upheld Roche's patent for Tarceva, but said that Cipla's generic, Erlocip, did not violate Roche's patent. The court dismissed Roche's complaint, saying that the molecular structure of Cipla's generic was different from that of Roche's drug. Roche continued to try and protect its best-selling cancer drug, and appealed against the order before a division bench in the Delhi High Court. A Roche spokesperson confirmed the mediation to Economic times, "We can confirm that pursuant to court orders we are in mediation with Cipla," she said. Patent experts called the development as unusual and surprising. "This is the first time that such a big-ticket patent litigation has been referred for mediation. It is highly unusual for the courts to send such cases for mediation at such a late stage in the proceedings, particularly since the trial has concluded in this case. While the court may have done so to save time and resources, India has lost an opportunity to evolve patent jurisprudence on an important matter," said patent expert Mr Shamnad Basheer. ]]> <![CDATA[Sanofi and Medtronic sign strategic alliance]]> https://biospectrumindia.com/news/95/1217/sanofi-and-medtronic-sign-strategic-alliance.html https://biospectrumindia.com/news/95/1217/sanofi-and-medtronic-sign-strategic-alliance.html Mon, 16 Jun 2014 16:09:00 +0530 The alliance will initially focus on the development of drug-device combinations and delivery of care management services to improve adherence, simplify insulin treatment, and help people with diabetes better manage their condition. "We know that insulin and other medicines are only one element of treating the whole patient. There is no day off in managing diabetes, and lack of adherence is one of the major hurdles of optimal disease management. That is why Sanofi is committed to developing integrated care solutions that focus on making life easier for people with diabetes and improving clinical outcomes that may help reduce costs in the overall healthcare system," commented Ms Pascale Witz, executive vice president, global divisions and strategic development, Sanofi. The alliance will be structured as an open-innovation model, leveraging the capabilities, as well as the human and financial resources, of both companies. Based on the success of the two initial priorities, the companies may explore other areas for potential collaboration, according to Sanofi's press statement. "Diabetes is unfortunately rising in prevalence around the world, driving up system costs and, most importantly, adversely impacting the lives of millions of people. Like Sanofi, we believe there is tremendous opportunity to better align care across the diabetes care continuum through new and varied technologies and patient care management strategies," said Mr Omar Ishrak, chairman and CEO, Medtronic. The alliance will pair Sanofi's extensive insulin portfolio and drug development expertise with Medtronic's expertise in insulin pumps and continuous glucose monitoring. Some of the priorities of the alliance will be to deliver novel drug-device combinations, including new form factors that are affordable, convenient and easy-to-use to increase therapy adherence and deliver better outcomes. These efforts will focus on improving the management of Type 2 diabetes, especially for people who cannot achieve glucose control even with multiple daily injections of insulin. ]]> <![CDATA[IPDA wants export ban on medicines lifted]]> https://biospectrumindia.com/news/95/7612/ipda-wants-export-ban-on-medicines-lifted.html https://biospectrumindia.com/news/95/7612/ipda-wants-export-ban-on-medicines-lifted.html Mon, 16 Jun 2014 14:59:00 +0530 Maharashtra Food and Drug Administration (FDA) enforced a ban on export of pharma products through parcel posts in February this year. Pharma companies in Maharashtra have been suffering losses of Rs four crore per day ever since. Mr Navneet Verma, IPDA secretary said, "The state should immediately intervene to stop harassment on the pretext of curbing clandestine activities. There is an issue of illegal exports, but because of some black sheep, the rest are suffering losses." He said that the IPDA has offered to help the government clearly define laws to curb illegal activities. The biggest negative impact of banning exports through parcel posts has been on the e-commerce trade of pharmaceuticals. It has completely crashed after the ban as parcel post is used to export consignments of less than five kgs. Maharashtra FDA had cited violation of Drug and Cosmetics Act of 1940, to impose the ban. However, this Act is not even applicable on exports, claims the association. It is meant to merely regulate manufacture, stocking or selling of drugs within the country. "Medical export falls under the 'Foreign Trade Policy' and not under Drugs and Cosmetic Act. Hence, FDA cannot ban export of pharma products", said IPDA members. The import and export business is monitored by the Reserve Bank of India and undertaken with the approval of Assistant Drug Controller of India and the customs department. Also, the powers of state drug regulatory authorities of any Indian state are limited to the manufacture and sale of medicines in that state. While state authorities can order a company to stop manufacturing a medicine under certain circumstances, it cannot issue an order to specifically ban exports. An IPDA delegation is scheduled to meet the Union Minister for Commerce Ms Nirmala Sitaraman to discuss this matter, IPDA sources said. ]]> <![CDATA[Gap between farm and shelf to be bridged: Food & Processing Minister]]> https://biospectrumindia.com/news/95/1672/gap-between-farm-and-shelf-to-be-bridged-food-processing-minister.html https://biospectrumindia.com/news/95/1672/gap-between-farm-and-shelf-to-be-bridged-food-processing-minister.html Fri, 13 Jun 2014 17:59:50 +0530 Mrs Harsimrat Kaur Badal, minister for Food Processing Industries, on a visit to Punjab mentioned that her priority is reduction of poverty by bringing the food inflation down and to do that the food processing sector has to a play central role in driving improvements into the country and in filling the gap between 'farm and shelf'. Minister said that to feed the increasing population, food shall be a very critical sector and apart from driving food processing growth, India would need to turn the wastage of fruits and vegetables into packaged food. This would be possible when all states focus on food processing industries. With a view to boost the food processing industries in Punjab, Mrs Badal met officials of various Food Processing government undertakings like Milkfed, Markfed, Punjab Agro and asked them to build BRAND PUNJAB and to focus on making Punjab, the number one State in terms of food processing. The minister also studied the practices being followed by various organizations in Punjab and suggested improvements and more market linkages. Talking to officials, Mrs Badal emphasized that all states need to make their own Brands, like 'Brand Punjab' which should be made and marketed globally both by government and by the industry of the state. She also met the Food Processing Commissioner of Punjab and discussed ways and means to improve food technology with Dr Nripendra Singh, head of the Food Science and Technology Dept of Guru Nanak Dev University. ]]> <![CDATA[Japan's Meiji Seika Pharma buys Medreich]]> https://biospectrumindia.com/news/95/2955/japans-meiji-seika-pharma-buys-medreich.html https://biospectrumindia.com/news/95/2955/japans-meiji-seika-pharma-buys-medreich.html Fri, 13 Jun 2014 17:49:26 +0530 Japan's Meiji Seika Pharma is set to acquire Bangalore-based generic drug maker Medreich for $290 million. The nine-decade-old company has acquired a 75 percent stake held by Medreich's three promoters and the rest 25 percent from private equity investor Temasek. Medreich will become a subsidiary of Meiji Seika Pharma but retain its name. Medreich has six manufacturing facilities, built to comply with standards stipulated by International Regulatory bodies. The facilities has been validated through successful inspections by various regulatory bodies, resulting in cGMP accreditations by the same. Medreich is a contract manufacturing and development company that sells generic drugs focused on Europe, Asia, Australia and New Zealand, and Africa. Major pharmaceutical companies like GlaxoSmithKline, Adcock Ingram, Pfizer, Sanofi, Novartis and Mylan are major customers of Medreich. It is involved in the manufacturing and marketing of a range of pharmaceutical products in various dosage forms, catering to diverse therapeutic categories including anti-infectives, multivitamins, analgesics and anti-histamines. In order to achieve sustained growth of pharmaceuticals business, Meiji Seika is striving to further grow its generic drugs market and actively expand its international business with a focus on Asia and other emerging markets. According to Meji's spokesperson, generic drugs market is rapidly expanding due to the government policy of reducing medical expenditures. In Asia and other emerging countries, the demand for affordable pharmaceutical products is expected to remain strong. Therefore, there is a need to expand cost-competitive production capacity to meet such increase in demand. Furthermore, as outsourcing for cost reduction is increasing in the pharma industry, sustainable growth of the contract manufacturing business is expected globally. ]]> <![CDATA[Rise in IPOs revive investments for the global pharma- biotech industry]]> https://biospectrumindia.com/news/95/3828/rise-in-ipos-revive-investments-for-the-global-pharma-biotech-industry.html https://biospectrumindia.com/news/95/3828/rise-in-ipos-revive-investments-for-the-global-pharma-biotech-industry.html Fri, 13 Jun 2014 17:40:14 +0530 The heightened private equity and venture capital (PEVC) deal activity in the global healthcare industry during the recession years, 2008-2010, witnessed a decline post-2010. However, the fall in deals was not uniform among constituent sectors, with the pharmaceutical, biotechnology and healthcare equipment sectors experiencing a much sharper decline in investor interest than the healthcare technology and provider segments. Investors started to bet on providers based on the conviction that they can provide quicker and safer returns than the pharmaceutical and biotechnology space, which is ridden with regulatory challenges and patent expires. New analysis from Frost and Sullivan's Private Equity and Venture Capital Investment in the Global Pharmaceutical and Biotechnology Industry reveals that the total number of PEVC deals in the pharmaceutical and biotechnology industry decreased from 1063 in 2010 to 480 in 2013. Though the returns from the pharmaceutical and biotechnology industry have been dwindling, they are better compared to the performance of other industries. "PE deals in the pharmaceutical sector have been relatively stable over the post-recession period whereas activity in the biotechnology segment began to decrease after reaching its peak in 2010, due to the uncertainty caused by healthcare reform in the US, long incubation periods, and delayed approvals," said a Frost and Sullivan Analyst. "VC deals across both these sectors also started to plummet from 2011 due to risks associated with regulatory uncertainty, long gestation periods, and increased cost of production." However, the strong comeback of initial public offerings (IPOs) in 2013 signals a positive outlook for investment in the pharmaceutical and biotechnology industry. The number of IPOs in the global biotechnology sector surged by 100 percent between 2012 and 2013, primarily on account of the 26 IPOs that took place in the US. IPOs in the pharmaceutical industry also rose with 11 deals in 2013, after the volume of IPOs declined to almost one-sixth of the sector's value between 2011 and 2012. As a result of the rise in IPOs, exit opportunities are expected to increase for investors. The trend will be further fuelled by the anticipated growth of corporate investor-backed IPOs. "PEVC investors in the global pharmaceutical and biotechnology industry have demonstrated maximum interest in oncology drugs, followed by anti-infective drugs and pharmaceutical contract laboratories," stated the analyst. "They have also concluded the maximum pharmaceutical and biotechnology-related PEVC deals in the US. and are expected to continue to do so in the forthcoming years. Industry players most aligned with these trends will be well positioned to obtain financial support from PEVC investors." Private Equity and Venture Capital Investment in the Global Pharmaceutical and Biotechnology Industry is part of the Financial Benchmarking in the Healthcare Industry subscription, which also includes research services in the following markets: Private Equity and Venture Capital Investments in Global Healthcare Industry, Analysis of Mergers and Acquisitions Trends in the US Healthcare Provider Industry, and Merger and Acquisition (M&A) Trends in the Global Pharmaceutical and Biotechnology Industry. All research services included in subscriptions provide detailed market opportunities and industry trends that have been evaluated following extensive interviews with market participants. Frost and Sullivan's Business and Financial Services group serves clients around the world in all aspects of financial analysis, market research and monitoring, due diligence, idea generation, opportunity analysis, investment valuation, and other proprietary research. ]]> <![CDATA[Wockhardt recalls its drugs in the US]]> https://biospectrumindia.com/news/95/3805/wockhardt-recalls-its-drugs-in-the-us.html https://biospectrumindia.com/news/95/3805/wockhardt-recalls-its-drugs-in-the-us.html Thu, 12 Jun 2014 16:35:44 +0530 Drug major Wockhardt has decided to recall over 8,000 bottles of anti-hypertension drug Metoprolol Succinate extended-release tablets in the US market. The decision was taken after the capsules failed a dissolution test. The bottles were manufactured by Mumbai based Wockhardt Ltd. and distributed in the US market by Wockhardt USA Inc. The withdrawal was classified as a Class-II recall, which the FDA defines as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. ]]> <![CDATA[Lucknow Biotech Park gets service tax exemption ]]> https://biospectrumindia.com/news/95/3549/lucknow-biotech-park-gets-service-tax-exemption-.html https://biospectrumindia.com/news/95/3549/lucknow-biotech-park-gets-service-tax-exemption-.html Thu, 12 Jun 2014 15:12:05 +0530 National Science and Technology Entrepreneurship Development Board (NSTEDB) has recently accorded recognition to Lucknow Biotech Park (LBP) for the purpose of service tax exemption for the incubator and its incubates. This will further help the Biotech Park in providing services to Biotechnology researchers and entrepreneurs. The LBP, set up jointly by the Department of Biotechnology, Government of India and the Department of Science and Technology, Government of Uttar Pradesh, is predominantly a technology incubator. The park has changed the paradigm of how science, biotechnology and entrepreneurship can be clubbed for the benefit of stakeholders and the society. It is a showcase of innovative industries and a model of active collaboration between industries, research institutes and academia. Besides holding hands of over 20 start up companies, the Biotech Park has motivated local scientists to venture into Biotechnology. ]]> <![CDATA[DCVax-L to boost GBM market to $623M by 2020]]> https://biospectrumindia.com/features/95/6016/dcvax-l-to-boost-gbm-market-to-623m-by-2020.html https://biospectrumindia.com/features/95/6016/dcvax-l-to-boost-gbm-market-to-623m-by-2020.html Thu, 12 Jun 2014 14:53:33 +0530 The company's latest report states that this significant growth comes despite patent expiration of Temodar (temozolomide) and will be driven primarily by the market entry of DCVax-L vaccine. This follows clinical trials showing that DCVax-L produces an Overall Survival (OS) of around 2.3 times longer than the current standard of care for newly diagnosed patients. Ms Angel Wong, analyst, GBI Research, says, "The current standard treatment of surgery, radiotherapy and chemotherapy, in combination with Temodar, has an OS of less than 15 months. As DCVax-L has been shown to extend OS substantially, the vaccine will demand a premium price once it hits the market." GBI Research expects DCVax-L, which has recently received early approval in Germany, to be approved in the US and EU in 2015 and 2016, respectively, ahead of less efficacious treatments Cotara and Rindopepimut (CDX-110), which will enter the global GBM treatment market in 2016 and 2017, respectively. DCVax-L has the added advantage of facing few other active competitors in the current GBM therapeutics market, an investment which is regarded as high-risk. Ms Wong further commented, "Clinical trials for new GBM treatments are extremely time consuming and have a high attrition rate. There are limitations in drug delivery techniques and the disease has low prevalence rates, making trial recruitment difficult. As a consequence, drug development is very costly. However, there remains a significant demand for therapies that show high potency against chemotherapy-resistant tumors, due to the limited OS benefits provided by current treatments. "As such, there are some attractive opportunities, particularly for recurrent GBM, as the unmet needs of these patients are not expected to be addressed by current players in the market," she concluded. ]]> <![CDATA[Jubilant announces price hike for Niacinamide]]> https://biospectrumindia.com/news/95/3538/jubilant-announces-price-hike-for-niacinamide.html https://biospectrumindia.com/news/95/3538/jubilant-announces-price-hike-for-niacinamide.html Thu, 12 Jun 2014 13:06:00 +0530 Jubilant Life Sciences, a significant player in the Nutrition market and ranked amongst the largest manufacturers of Vitamin B3 (Niacin and Niacinamide) in the world on June 12, 2014 announced a price-increase of 9 percent for Niacinamide, with immediate effect, for non-contract customers and wherever existing contracts permit. Jubilant delivers unmatched advantages of consistent quality and availability of Vitamin B3 (Niacin & Niacinamide) to its customers globally. The company's nutrition business is backward integrated up to the initial raw material stage with global scale of operations. ]]> <![CDATA[Strides receives regulatory nod for its skin disease drug]]> https://biospectrumindia.com/news/95/3424/strides-receives-regulatory-nod-for-its-skin-disease-drug.html https://biospectrumindia.com/news/95/3424/strides-receives-regulatory-nod-for-its-skin-disease-drug.html Thu, 12 Jun 2014 12:36:07 +0530 Bangalore-based Strides Arcolab has received regulatory approval for its skin disease drug Methoxsalen. The drug is available in capsules of 10 mg. The USFDA approval will mean that the capsules can now be sold in the US. "The US market for generic Methoxsalen capsules is pegged at about $13.6 million, with no other generic player in the same market," the company said, citing IMS data."The product will be manufactured at the company's FDA-approved oral dosage facility in Bangalore and marketed directly by Strides in the US," they added further. Methoxsalen is used to treat psoriasis, eczema, vitiligo and some cutaneous lymphomas in conjunction with exposing the skin to UVA light from lamps or sunlight. It modifies the way skin cells receive UVA radiation, clearing up the disease. ]]> <![CDATA[GM mosquitoes: Weapon against malaria]]> https://biospectrumindia.com/news/95/3761/gm-mosquitoes-weapon-against-malaria.html https://biospectrumindia.com/news/95/3761/gm-mosquitoes-weapon-against-malaria.html Wed, 11 Jun 2014 16:21:00 +0530 The sex selection technique produces a generation of mosquitoes which are 95 percent male, as opposed to 50 percent in normal populations as reported. Production of only a sperm reduces the number of females, leading to a dramatic reduction in the population and eventual decimation. This curbes the risk to humans as the malarial parasite is transmitted through the blood-sucking female mosquitoes. "Malaria is debilitating, often fatal and we need to find new ways of tackling it," said study leader Ms Andrea Crisanti, a professor at Imperial College London. "We think our innovative approach is a huge step forward. For the very first time, we have been able to inhibit the production of female offspring in the laboratory, and this provides a new means to eliminate the disease." Malaria kills more than 600,000 people each year, as per the World Health Organisation (WHO) statistics. The result of six years' work, the method focuses on Anopheles gambiae mosquitoes, the most dangerous transmitters of the malaria parasite. Scientists injected a stretch of enzyme DNA into the genetic code of male mosquito embryos. The modification essentially shreds the X chromosome during sperm production in adults. As a result, almost no functioning sperm carried the X chromosome, which determines the female offspring. Instead, most sperm carried the Y chromosome, which produces males. The modified mosquitoes were put to the test in five cages, each containing 50 genetically modified males and 50 normal, wild females. In four of the five cages, the entire population was wiped out within six generations because of the progressively greater shortage of females. Modified male mosquitoes produced only male heirs, which did the same until there were no females left. "The research is still in its early days, but I am really hopeful that this new approach could ultimately lead to a cheap and effective way to eliminate malaria from entire regions," said Prof. Roberto Galizi, Imperial college London. Commenting on the research, University of Oxford specialist Mr Michael Bonsall said the research was "super cool work." "This has important implications for limiting the spread of malaria," he added. "It will be very exciting to see how this specific technology is now taken forward." ]]> <![CDATA[Genomics picking up pace in India ]]> https://biospectrumindia.com/features/95/7615/genomics-picking-up-pace-in-india-.html https://biospectrumindia.com/features/95/7615/genomics-picking-up-pace-in-india-.html Wed, 11 Jun 2014 14:27:07 +0530 Genomics research in India has grown leaps and bounds in the past 20 years. Funding agencies including the Department of Biotechnology (DBT), Department of Science and Technology (DST), Indian Council of Medical Research (ICMR), Council of Scientific and Industrial Research (CSIR), and Indian Council of Agricultural Research (ICAR) have been steadily increasing the quantum of funding and grant programs in the area. Scientists from eminent institutes like IARI, CCMB, IGIB, NIPGR, and NBRI have contributed significantly towards genomics research. A good number of private, non-profit DSIR (Department of Scientific and Industrial Research) recognized institutes are gaining momentum in quality genomic research. Currently, genomics is said to be at a very nascent stage in India. Even academic interest in this field is yet to pick-up steam. Research data in the genomics space is minimally available in the country. Thus, in the Indian context, this calls for a collaborative effort between academia and private organizations. At the global level, India seems to be way behind other countries. "Scientific papers published in top journals are very few, and Indian impact or even participation in global research efforts is minimal. Indian Genomic research has to improve a lot, both in quality and quantity when compared not only with western countries but also with countries like China. There needs to be a lot of transparency, reduced bureaucracy and red tapism when it comes to the process followed by funding agencies. Also, scientists need to raise the bar of grant proposals and manuscripts that are published. They need to collaborate more with the private sector. It is a surprise that India with a population of 1.2 billion is not a part of Human Genome Project, and also 1,000 Genome Project in any significant way," expressed Mr Sam Santhosh, CEO, SciGenom. On the other hand, Dr Raja C Mugasimangalam, founder and CEO, Genotypic Technology, has a different opinion. He added, "We were the first to bring Genomics to India and started providing services back in 1999. India is not lagging behind and it is like any other country as a result of globalization. Genomics is applied in every field including agriculture, biopharma, pharmaceuticals and biotechnology to name a few. Genomics is essentially an enabling technology and it doesn't have any boundaries like biotechnology. Right now it is difficult to define the exact market value of genomics with numbers and figures." Genomics has benefited significantly in the last few years due to major revolution in DNA sequencing technologies. While it took 10 years and $3 billion to sequence the first human genome by 2003, it can now be done in 10 days for as little as $5,000. The new set of technologies that have made this possible are called 'Next Generation Sequencing' technologies or simply, NGS. This drastic reduction in cost along with a dramatic increase in speed using NGS has enabled scientists across the world to sequence the genome of many species of animals, plants and microbes. Dr Partha Majumder, director, National Institute of Biomedical Genomics (NIBMG), Kolkata, said, "We now have access to the next-generation sequencing platform. The result have been a tremendous impetus with increase in genomics research and its applications." The research data generated has enabled scientists not only to understand how genome's function, but have also helped create new drugs, understand diseases, enhance crops, clean-up the environment, and even generated biofuel. "In fact, through genomics we might even create new life forms through synthetic biology," says Mr Sam Santhosh. Genomics is expected to drive the next wave of personalized medicine, nutrition and fitness, and possibly save millions of lives in the process. In a time where big data is held high in analytics, genomic data along with other types of aggregated information such as lifestyle and clinical data, can bring about accurate risk predictions. Today, most of the cancer treatments are based on genomics, though chemotherapy is often the primary treatment. Genomics can help determine the type of chemotherapy that a patient can be given. In fact, genomics has gone beyond just predicting susceptibility of patients to certain diseases. Since genomics has application in biology and applied biology, it opens up numerous avenues and ways of creating new companies and products that were never imagined before (For example, siRNA technology is a new class of drugs, and a product of genomics). So far, sequencing the genome has enabled deciphering of the code of life. Mr Sam Santhosh further added, "Though the current understanding of this code is very meager at present, it will us amass knowledge over the next 10 or 20 years. Its impact on healthcare and biotechnology will be remarkable. The current paradigm of making drugs for the general population will vanish." In a few years, most drugs will be based on specific genetic mutations and targeted towards a set of individuals. Convergence with other technologies like nanotechnology, artificial intelligence and robotics will see the development of new devices like 'nanobots' (for example, very small robots entering the bloodstream and fixing problems like clots) and even create body organs like heart, liver, and kidneys. Right now in India, the challenge is in gathering high-quality clinical information from patients. Our hospitals, most of the time, are over-crowded and it is impossible for clinicians and doctors to gather clinical information from every individual patient. As huge quantities of data is generated, it calls for qualified and skilled analytical personnel and manpower to handle them. Dr Majumder said, "Our biggest challenge is that there are many diseases that need to be thoroughly researched because there is plenty of evidence that they have genomic underpinnings to them. On the other hand, R&D is not cheap either. It requires a strong funding support. We can do a lot more with proper funding and infrastructure." Public-private partnerships can partly help solve the funding issue, but most of the time they halt at the negotiation level. "Funding from the government will be fantastic and that kind of money, if provided, can be used to achieve much more in genomics. Private companies are looking for outcomes. They lose interest as they look for solid return on investment (ROI) over a short period of time," concluded Dr Majumder. ]]> <![CDATA[DCGI's prolonged approval process worries drugmakers]]> https://biospectrumindia.com/news/95/4184/dcgis-prolonged-approval-process-worries-drugmakers.html https://biospectrumindia.com/news/95/4184/dcgis-prolonged-approval-process-worries-drugmakers.html Tue, 10 Jun 2014 16:36:00 +0530 The Indian Pharmaceutical Alliance (IPA), the industry body representing leading pharma companies, has written a letter to the health minister, Dr Harsh Varadhan, stressing the need for an out-of-court settlement with health activists, fighting for the rights of clinical trial participants. The report mentioned that this was suggested in order to avoid delay in research, and that the ongoing litigation in the Supreme Court is hindering drug development and research work in the country. "The government's job should be to create enough safeguards and provisions to ensure that the rights and safety of subjects in a clinical trial are not compromised but this does not mean stopping business or development work," the IPA said, adding "what is happening now is hindering access to affordable medicines and this is not in favour of patients either." "It is, therefore, necessary that the ministry initiate a dialogue with petitioners to allow the Central Drugs Standard Control Organisation (CDSCO) to function normally," it stressed. Drug makers argue that the research work has almost come to a standstill due to the stringent directives from the apex court asking the government and the Drug Controller General of India (DCGI) to keep a tab on clinical trials and new drug approvals to ensure safety of patients. While the pharma sector is complaining that even genuine trial applications and new drugs are suffering and facing delays, the regulator is being cautious in the light of the court's directive. As per the DCGI's website, merely 25 clinical trials have been approved by the DCGI in the first five months of 2014, compared with 107 in 2013. The slowdown in clearance is also evident in the case of new drug approvals. While 35 new drugs were approved by the regulator in 2013, only seven new medicines have received a go-ahead so far this year. The report also said the health ministry must adopt "a reasoned and hardened position" vis-Ã -vis the apex court to let the executive function. According to a senior official, around 200 applications seeking permission to conduct clinical trials are pending with the regulator. Officials pointed out that earlier, an approval used to take 12-16 weeks, whereas now there are no clear timelines for a regulatory clearance. This is directly impacting the growth of pharmaceutical companies as well as clinical research organisations. In the past year, the Rs 80,000 crore domestic pharmaceutical sector has witnessed a significant decline in growth. ]]> <![CDATA[Mysterious litchi syndrome kills 8 in West Bengal]]> https://biospectrumindia.com/news/95/6048/mysterious-litchi-syndrome-kills-8-in-west-bengal.html https://biospectrumindia.com/news/95/6048/mysterious-litchi-syndrome-kills-8-in-west-bengal.html Mon, 09 Jun 2014 12:58:28 +0530 Bangalore: A new virus spreading from the litchi fruit has killed at least eight children and left several others serious in the Malda district of West Bengal, India. The affected children were found to be between the age group of 3 and 5 years. The virus is reported to cause encephalopathy, a grave condition leading to high grade fever, vomiting and convulsions. At present, six children with symptoms are being treated at the medical college. Abundant production of litchi and the falling prices had led to huge consumption of the fruit this year, sources said. According to reports, Malda had been a victim of the disease earlier too. The year 2012, reported 100 children dying of the disease. Dr M A Rashid, vice-principal of Malda Medical College appealed to the people to admit their children as soon as they see any symptoms associated with encephalopathy. The district administration remained clueless on prevention or control and has sent a team to the affected villages to analyze the situation. Mr Krishnendu Choudhury, minister of food processing and horticulture said that, "The virus spread from the fruit and due precautions would be taken to prevent the occurrence of a possible epidemic." ]]> <![CDATA[Inadequate data hampering efforts: Health Min]]> https://biospectrumindia.com/news/95/4033/inadequate-data-hampering-efforts-health-min.html https://biospectrumindia.com/news/95/4033/inadequate-data-hampering-efforts-health-min.html Mon, 09 Jun 2014 11:44:32 +0530 Speaking at a function on May 5, 2014 to mark world environment day, the health minister, Dr Harsh Vardhan lamented that inadequacy of data is hampering efforts of the health administrators, whether at the center or in the states, to address emerging environmental health threats that need urgent attention and a proactive approach. Dr Vardhan expressed concern about the insufficient data available with health authorities in India on adverse health outcomes and disease burden attributable to various environmental hazards. There is scant information available on the adverse impact on health caused by ecological and environmental deprivation at local, regional and national scale, he stated. ''The movement of masses and a sizable population of migrant labourers make this mission difficult without inter-sectoral and inter-state coordination,'' he said. For this purpose, the health minister announced that a Management Information System using IT tools will be developed for the benefit of central and state health departments. The minister said, "The United Nations, WHO and all international institutions have warned of the dangerous link between deteriorating environment and disease outcomes. We need to fight this negative impact by applying established tools to gather information, and share it with the community to involve them in this movement, for creating a healthy and safe environment. We also need to undertake a massive capacity building exercise to create a pool of trained manpower to achieve this mission." As an example, he cited a typical case of silicosis, a disease that has resulted in profound morbidity and mortality but with little information at hand as to its magnitude and size. ''A man arrives from eastern Uttar Pradesh, finds work in the capital's construction sector and soon gets tuberculosis and silicosis. When he gets sick and cannot work anymore, he goes back with no one realizing the true nature of his health problem,'' he said. The minister commented that the health ministry and its satellites in various states need an institution like the Indian Agricultural Statistics Research Institute (IASRI). So for the short term, he has decided to commission a Management Information System (MIS) using IT tools which would, at the click of a mouse, make available a host of valuable data gleaned from computers at every tier of the health infrastructure. "My idea is to create an aggressive data collection system and research organization for the health sector which would preferably be autonomous. I will take up this matter with the Prime Minister soon and involve the state governments in the endeavour," Dr Harsh Vardhan added. Dr Harsh Vardhan also announced a sanitation drive for a week in the government hospitals run by the Central Government in the capital and declared that he shall soon visit these hospitals to monitor the drive. ]]> <![CDATA[Glenmark opens new unit in Switzerland]]> https://biospectrumindia.com/news/95/1035/glenmark-opens-new-unit-in-switzerland.html https://biospectrumindia.com/news/95/1035/glenmark-opens-new-unit-in-switzerland.html Fri, 06 Jun 2014 14:14:11 +0530 Leading Indian drug maker from Mumbai, Glenmark has opened a new mAb manufacturing facility in Switzerland. This is in line with the company on-going work on both novel monoclonal antibodies and biosimilars and the need for more manufacturing capacity for its clinical trial work. Reports have explained how many companies have undertaken expansion projects with more mAbs and antibody-drug conjugates being developed for attacking cancers. Glenmark Biologics President Michael Buschle explained that the company has a number of mAbs in various stages of development, including bispecific antibodies, and so needed more capacity. "The manufacturing facility would help us bring these antibodies to the clinic faster and position Glenmark as a leading innovative pharmaceutical company," he said in a statement. The manufacturing facility is in La Chaux-de-Fonds, Switzerland, where Glenmark has an integrated research center for antibody discovery and development. The new manufacturing facility will employ single-use bioreactor systems and also includes a suite for manufacturing cell banks. The company has not disclosed any financial details about investment into the new facility. It is said to have employed 69 people there. ]]> <![CDATA[EU concludes inspection of Ranbaxy's Toansa unit]]> https://biospectrumindia.com/news/95/4597/eu-concludes-inspection-of-ranbaxys-toansa-unit.html https://biospectrumindia.com/news/95/4597/eu-concludes-inspection-of-ranbaxys-toansa-unit.html Fri, 06 Jun 2014 14:09:57 +0530 Ranbaxy's manufacturing unit in Toansa that had come under close regulatory scrutiny recently can now breathe a sigh of relief. Concluding its long inspection of the unit, the European regulatory authorities have finalized their assessment of reported non-compliance with Good Manufacturing Practice (GMP) at the drugmaker' facility. The European Union had earlier suspended the GMP certificate for this site based on certain deficiencies. However, Ranbaxy has now said that the regulators concluded that there was no risk to public health by these deficiencies. Reports added that although the assessment showed that there were a number of GMP deficiencies at the concerned site, assessment of all available information has reassured European regulators that there has been no risk to public health from these deficiencies. This has certainly come as a relief to the company that is currently majority-owned by Japan's Daiichi Sankyo but is subject of a $4 billion takeover by another Indian drug major Sun Pharmaceuticals. The company added that the European regulators have also considered the corrective measures put in place by the company and were satisfied that the measures are sufficient to ensure GMP-compliant manufacture of products at the site. It added that the EU authorities have also decided to reinstate the GMP certificate which was suspended in January 2014. The certificate will be re-entered into EudraGMDP, the EU database that contains GMP certificates. Reports explained how the EU assessment earlier was followed by an inspection by the US Food and Drug Administration that revealed areas of non-compliance with GMP at the site. The European medicines regulatory network responded quickly to the FDA's findings, and sent a team of inspectors from Germany, Ireland and the UK, who were joined by inspectors from Switzerland and Australia to undertake an unannounced international inspection of the site. The GMP inspection concluded that appropriate corrective and preventive measures have been put in place by the manufacturer. The inspection team concluded that there was no evidence that any medicines on the EU market that have an active pharmaceutical ingredient manufactured in Toansa were of unacceptable quality or presented a risk to the health of patients taking them. This conclusion was supported by tests of samples of these medicines, all of which met the correct quality specifications. European regulatory authorities have identified the need to keep the Toansa site under close supervision and this will be done in collaboration with India and other regulatory authorities around the globe, Ranbaxy stated. The Toansa site had been supplying APIs for four centrally authorized medicines - Enyglid (repaglinide), Repaglinide Krka (repaglinide), Repaglinide Teva (repaglinide) and Nevirapine Teva (nevirapine) - and several non-centrally authorized medicines. ]]> <![CDATA['Research yet to unleash nano applications in biosciences']]> https://biospectrumindia.com/features/95/5507/research-yet-to-unleash-nano-applications-in-biosciences.html https://biospectrumindia.com/features/95/5507/research-yet-to-unleash-nano-applications-in-biosciences.html Fri, 06 Jun 2014 10:41:57 +0530 Nanobiotechnology is an interdisciplinary field which cannot be ignored at any point in the biotech industrial sector. It has contributed more importance in converting research into applications, especially drug delivery system and drug discovery process. Surveillance report in the recent past shows that several consumer products with the application of nanotechnology are not yet found majorly in biotechnological products. More research is require to unleash nano applications in biological sciences, and hence there is less contribution by the Indian industry who have so far lead the biotech market. Product research in nanobiotechnology is carried by very few Indian lifescience companies which is alarming signal to all their comrades. Says Mr Baskar Viswanathan, director of research, BioLim Biosolutions, "Queries and demands in the existing biotechnology market have set immense potential to describe the opportunities in nanobiotechnology sector. The key role played by the nano materials in the biotech products are widely followed by western countries. Hence the market achievement is huge and the opportunities it floods in to the biotech market will inclusively set new trends in our biotech commodities." Western cultures are more and more branded with the buzz word 'nano' in the consumer products, for instance, microelectronics, cosmetics, pharmaceutics and food industries. Our biotech market ratio are predominantly lead by the pharma sector in terms of biosimilars, and its drug delivery process. "Revolution can be brought into the pharma market if it can overcome several drawbacks in the drug delivery process," comments Mr Viswanathan. "Whereas, drug delivery process was ultimately determining the overall consequence of the administered drug. Huge opportunities are opening up for latest practices in nano-enabled machines and vehicles for drug administration with patient compliance,'' he further added. Environmental pollution is still an unraveled area where research demand is put forth hugely for biotech industries, whereby the nano materials it can constructively decrease pollutants. Hence, there is a big market share to be played by the nanobiotechnology products. "However, lack of public awareness in identifying nano products is another reason for trailing inputs in the nano sector. Few healthcare, especially, cosmetic products are being released in markets with the involvement of nanotechnology, which is gathering less attraction in the crowd," explains Dr Viswanathan. Mr Viswanathan feels that nanotechnology can work with any object making it better than how it was previously. "There are several examples which can be mentioned in areas like textiles, electronics, cosmetics, pharmaceutics and food. Nanotechnology has become, apparently, applicable in all these areas especially, skin lotion creams to protect from UV sun light for longer time, stain free fabrics, anti-infection bandages with higher efficiency, accurate pregnancy test kit, anti-microbial water purifiers, and anti-sensitive tooth pastes for preventing dental sensitivity. Nanotechnology has already influenced few other applications in molecular recognition principle in diagnosis as well as drug development process, but yet to reach the consumer products," elucidates Mr Viswanathan. Hence in different perspective nanotechnology can be applied to any field where demands for improvisation exists. ]]> <![CDATA[Bayer's CEO to step down by 2016]]> https://biospectrumindia.com/news/95/1052/bayers-ceo-to-step-down-by-2016.html https://biospectrumindia.com/news/95/1052/bayers-ceo-to-step-down-by-2016.html Thu, 05 Jun 2014 16:04:08 +0530 Bangalore: German drug maker Bayer announced that Dr Marjin Dekkers will step down as the CEO, by the end of 2016. The firm said that Mr Dekkers' contract which was to expire by the end of this year, would be extended only for a period of two years. "The contract of Dr Marijn Dekkers will be extended by just two years in line with his own wishes," said the company in a news report. Mr Dekkers apparently cited family reasons for extending his contract only until the end of 2016. Though Bayer has not announced any successor to Mr Dekkers, the firm has declared current chief financial officer Mr Werner Baumann as the chief of strategy and portfolio officer. This reorganization is to ensure continuity in operations and future developments, said the concern. In a letter to the employees, Mr Dekker appreciated Bayer's success and said commitments in his personal life demanded his time currently and that his obligations as chief executive at Bayer would not give him this personal flexibility. Mr Dekkers contribution to Bayer has been noteworthy, including the acquisition of Merck and Co's consumer care unit and expansion of Bayer's pharmaceutical businesses over the years. ]]> <![CDATA['Biotechnology: A tool for future food security']]> https://biospectrumindia.com/features/95/4931/biotechnology-a-tool-for-future-food-security.html https://biospectrumindia.com/features/95/4931/biotechnology-a-tool-for-future-food-security.html Thu, 05 Jun 2014 15:56:41 +0530 All of these efforts are important, but the most critical arena of operations in the effort to preserve our planet is one that may surprise you: the farm. So huge is agriculture's environmental footprint that its success or failure in achieving sustainability will be a key determinant of our planet's fate. Policymakers and opinion leaders everywhere need to understand: Agriculture is at the pivot point of the 21st century. The scarcity of water and land Tremendous progress has already been made. But we need much more. Consider water. The basic facts are very simple. We depend on fresh water to sustain life, yet the supply is finite and relatively small. Just 2.5 percent of all the water on the planet is fresh, and most of that for various reasons is unavailable. Moreover, humanity is consuming water faster than ever-at more than twice the rate of population increase in the last century. Meanwhile, projections call for a global population increase of more than 2 billion between now and 2050. By 2025, the United Nations forecasts, two out of every three people will live in water-stressed regions. All of us who work in agriculture have a huge responsibility here. Some 70 percent of fresh water is consumed by food production. We always have depended on farmers to be good stewards of the land, but today's farmers are also responsible for sustainable use of other resources too-water included. Another challenge lies right under our feet: having enough productive soil to grow food. To feed today's population, we already use a land mass the size of South America. But feeding the globe's larger population by 2050 could require another land mass of that size. No other South America is waiting to be discovered, and we should work to preserve the remaining rainforests and grasslands. But we have many opportunities to meet this food supply challenge without using more land. More efficient distribution and storage of food need to be part of the answer, but the most immediate and important opportunity is greater productivity. Three tools for future food security Over the last 30 years, farmers across the globe have doubled corn production while reducing the total amount of land, energy and water invested by 30 to 50 percent. With a combination of existing and new tools, we can replicate that kind of performance with other crops. Three good examples are advanced irrigation, no-till farming, biotechnology and advanced breeding. 1. Advanced irrigation: Some traditional irrigation methods waste a staggering 35 to 50 percent of water used. Through better irrigation systems and better management practices, we dramatically can increase efficiency. Drip irrigation, in which water is applied directly to a plant's roots, can limit waste to 5 or 10 percent. Additionally, our rising ability to crunch "big data" provides precise information on local soil and weather conditions, leading to better decisions about how much water to use and when. Farmers worldwide are trying to grow "more crop per drop." Monsanto recently committed to a 25 percent increase in irrigated water-use efficiency of our operations and contract farms by 2020, which we project will save between 30 billion and 80 billion gallons a year. With today's technology, such goals can be met. 2. No-till farming. Growing crops without having to tear up the soil offers a bouquet of environmental advantages. No-till, enabled by genetically modified seeds, keeps vast quantities of carbon harmlessly sequestered in the ground while also conserving water and reducing soil erosion. No-till also means a reduction in the burning of fossil fuels for tractor trips back and forth through fields. No-till represents a potential savings to greenhouse gas emissions of some 26 million tons every year - the equivalent of taking all of California's 12 million cars off the road. 3. Biotechnology and advanced breeding. Through both genetic modification and advanced breeding techniques, scientists are developing seeds that better resist drought, insects and other pests. These seeds give farmers a chance to adapt to climate change and grow more with less. During the US drought of 2012, the combination of GM crops, advanced breeding and improved agronomic techniques helped keep corn yields nearly 40 bushels per acre higher than they had been the last time the Corn Belt dried up that badly, in 1988. That nearly 50 percent improvement represented enough calories to feed about 1 billion people for more than six months. These are only a few of the tools that farmers will need to meet our globe's growing demand for nutritious, affordable food - sustainably. More are needed from companies, universities, research centers, foundations, civil society, governments and farmers themselves. We also need more partnerships among these various participants; fortunately, signs of that cooperation are growing. If we all understand the stakes involved in making agriculture sustainable, there is every reason to believe we can do it. ]]> <![CDATA['Indian VCs super-inclined towards IT']]> https://biospectrumindia.com/features/95/6429/indian-vcs-super-inclined-towards-it.html https://biospectrumindia.com/features/95/6429/indian-vcs-super-inclined-towards-it.html Thu, 05 Jun 2014 15:29:21 +0530 With an unquenchable vision in the field of biological sciences, Dharwad-based Dr Swamy's Lab was set-up in 2012 in Karnataka, with an investment of Rs 1 crore, focusing primarily on molecular biology reagents and kits, biopharma, biofuels, molecular diagnostics, and instrumentation. Initially the company was incubated at Institute of Agri-Biotechnology (IABT), University of Agricultural Sciences in Dharwad. "Practically, small cities are very good for start-up biotech companies because they need a lot of incubation time. The minimum incubation period for a biotech start-up is anywhere between 5-6 years in small cities. This incubation time is very critical for its survival. Therefore, we chose Dharwad to be our starting place," justified Dr Thippeswamy. After obtaining his PhD in Biochemistry from Gulbarga University in 2002, Dr S Thippeswamy, who is now the founder, chairman and MD of Dr Swamy's Lab, was selected as the candidate for DBT sponsored post-doctoral fellowship at the Indian Institute of Science (IISc). Dr Thippeswamy says that while planting his company, he faced enormous challenges in convincing his family, relatives and friends, who were the only primary channel of funding during the company's inception. "The industry as a whole faces a major challenge in finding rightly qualified and skilled manpower who are motivated. Sadly, investors are not ready to invest in the field of biotechnology," he laments. After establishment, the company also encountered challenges in managing employees, cold chain transportation systems and raising capital, as no funds were borrowed from banks. In 2005, after completing his post-doctoral research at IISc, Dr Thippeswamy moved to Weizmann Institute of Science in Israel. It was then that he conceived the idea of establishing his own company in India. Dr Thippeswamy feels that biotech in India is still at a nascent stage. Speaking on the company's collaborations, Dr Thippeswamy added, "We are now in communication with the Department of Biochemistry and Molecular Biology at the Ohio State University in the US. Also we are looking forward to work with the Institute of Agri-Biotechnology (IABT), University of Agricultural Sciences in Dharwad, and also with the Department of Electronics, Kottureshwara College, Kottur in Bellary. We are interested in public-private partnerships as well." Currently Dr Swamy's Lab is involved in the development of highly sensitive (one copy) real time PCR based diagnostic kits, and isothermal PCR methods for diagnostics. Also, its R&D involves developing biohydrogen from genetically modified algae, and pre-clinical studies of gels to check transmission of HIV. To all the aspiring entrepreneurs in the industry, he advised, "In the present context, India is not a suitable country for biotech start-ups. If you still want to forge ahead, then you should have a clear, short-term income plans, and assured backup funds for the first five years. In the biotech industry, self-motivation is of prime importance." The company is now eyeing molecular diagnostics, and molecules that are useful for diabetic patients. As the founder of a biotech start-up, Dr Thippeswamy enlists various expectations from the new government. Commenting on the biotech agenda for the new government, he expressed, "Developing the right infrastructure and providing uninterrupted power supply and water is crucial." "There needs to be a single window system for obtaining all government licenses, certificates, loans, and projects especially related to GMOs, environment and biodiversity. Also, the government should strive to protect intellectual properties, and develop excellent human resources by polishing the quality of higher education in the country," elucidated Dr Thippeswamy. In the future, as a part of its expansion strategy, Dr Swamy's Lab will venture in to areas including biogas, biohydrogen and biopharmaceuticals. "We will be releasing our molecular diagnostics with isothermal PCR techniques. We will also be setting up one of the greatest R&D center in the near future," opined Dr Thippeswamy optimistically. According to him, venture capitalists in India show more affinity towards IT, real estate, trade and retail marketing. "The major drawback is that there is very little development seen in the manufacturing sector. The government should simplify industry laws and regulations, along with offering low-interest loans to start-ups," he concluded. ]]> <![CDATA[GVK EMRI awarded PPP initiative of the year]]> https://biospectrumindia.com/news/95/5819/gvk-emri-awarded-ppp-initiative-of-the-year.html https://biospectrumindia.com/news/95/5819/gvk-emri-awarded-ppp-initiative-of-the-year.html Thu, 05 Jun 2014 14:14:00 +0530 GVK EMRI (Emergency Management and Research Institute), the largest professional Emergency Service Provider in India has been awarded the "Public Private Partnership (PPP) Initiative of the Year in Healthcare" at the National Summit on ICT organized by ASSOCHAM at New Delhi on May 04, 2014. Mr K Krishnam Raju, director in-charge, GVK EMRI received this prestigious award from the chief guest, Mr Lov Verma, IAS, secretary, ministry for health and family welfare, Government of India. GVK EMRI has pioneered the art of Information and Communication Technology (ICT) in their healthcare delivery system with committed research and investment. Supported by latest technology in distress communication and management, GVK EMRI revolutionised the concept of Emergency Care Services in India. The organisation has established an Emergency Response System that coordinates emergency through a single toll free number 1-0-8. When called in an emergency, it ensures prompt communication and activation of a response which includes assessment of the emergency, dispatch of ambulance along with a well-trained emergency medical technician to render quality pre-hospital care and transport of the patient to the appropriate health care facility. The system has also put in place the strategic principle of "right patient to the right hospital in the shortest possible time", all built on a high-end technology platform. On the event of this esteemed recognition, Dr GVK Reddy, founder and chairman of GVK said, "We are honoured to receive this award. This indicates that our quest to develop meaningful propositions beyond just business success, is an integral part of our journey to excellence. It is an encouragement to our commitment to saving lives and bettering the healthcare services in the country." Mr Krishnam Raju commented, "This recognition for GVK EMRI serves as further encouragement to develop services and systems that can help save lives. We are grateful to ASSOCHAM for creating a Summit that serves as a wonderful platform to learn and share experiences among all stakeholders." With a vision to respond to 30 million emergencies and save 1 million lives annually and to deliver services at global standards, GVK EMRI is acknowledged as the most efficient, speedy, reliable and caring service provider in its category. It is the life saviour in 14 states and two Union Territories (Andhra Pradesh, Gujarat, Uttarakhand, Goa, Tamil Nadu, Karnataka, Assam, Meghalaya, Madhya Pradesh, Himachal Pradesh, Chhattisgarh, Uttar Pradesh, Rajasthan, Kerala, Diu Daman and Dadra Nagar Haveli). The service covers more than 750 million people, more than half of India's population-making it the world's largest integrated emergency service provider. "The key approach in the health MMP will be to have an architecturally connected system in each state and thus integrating all the required components, whether they are covered in one system or many," said Mr Verma. "The broad focus areas for health MMP are public health, patient care, health administration and governance." Talking about the role of ICT in healthcare sector, the secretary said, "With ICT adoption in health systems, we are hoping to achieve remote consultation, diagnosis and treatment through tele-medicine, facilitate collaboration and co-operation among healthcare providers." He also said that ICT will bring a lot of transformation in healthcare service delivery as providers will have easier access to patient data and citizens will get the benefit in terms of better healthcare services. Prevalence of paper based record keeping system, inaccessibility of healthcare information to citizens and patients, absence of effective and transparent grievance redressal system, absence of e-referral system, data duplication due to issues in data collection and reporting, shortage of doctors and other healthcare specialists, lack of timely and accurate information and analytics tools for decision making together with improper utilization of existing technology in healthcare are certain major challenges being faced in India vis-Ã -vis health and IT, further highlighted the secretary. ]]> <![CDATA[Affigenix develops companion diagnostics for diabetes management]]> https://biospectrumindia.com/news/95/7918/affigenix-develops-companion-diagnostics-for-diabetes-management.html https://biospectrumindia.com/news/95/7918/affigenix-develops-companion-diagnostics-for-diabetes-management.html Wed, 04 Jun 2014 16:39:58 +0530 It won the award for developing the in-vitro diagnostic kit for diabetes management. "We are hoping our simple, user friendly, affordable lateral flow kit will become preferred companion diagnostic kit along with the routine Glucose test and HbA1c measurement for diabetes management. The kit will enable doctors to make informed decision and prescribe personalized medicine that will be more efficacious in controlling glucose levels in ~7 million diabetic patients who depend on insulin in India alone," added Dr Arumugam Muruganandam, MD & CSO, Affigenix Biosolutions. The India Innovation Growth Programme is a joint initiative of the Department of Science and Technology, Government of India; Lockheed Martin Corporation; Indo-US Science and Technology Forum, Federation of Indian Chambers of Commerce and Industry; Stanford Graduate School of Business and the IC2 Institute at the University of Texas. The aim of this programme is to accelerate innovative Indian technologies into the global markets. The India Innovation Growth Program is the only program of its kind, focusing on teaching using world-class commercialization strategies and the business development assistance provided. About the Innovation Companion Diagnostics for Diabetes Management Introduction: Type 1 Diabetics (T1D) depends on insulin injection daily for their survival and if the body develops anti-insulin antibodies and neutralize the injected insulin, the glucose control is lost. The patient develops complications and will eventually die. The innovation offers a simple lateral flow test similar to pregnancy test to detect anti-insulin antibodies, and there by allow doctors to make informed decision to change the dose or switch the patients to other insulin analogues. Application: The in-vitro diagnostic (IVD) kit will aid doctors to rapidly determine whether the loss of efficacy of insulin or its analogue in T1DM patients is due to presence of antibodies in patient's serum. This will enable doctors prescribe personalized medicine that will be more efficacious in controlling glucose levels. Uniqueness: The IVD kit for detecting insulin antibodies is an unmet medical need in India, and in major parts of the world. It is an alternative to sensitive, quantitative, time consuming and expensive radioactive and cell-based assay that are used in developed countries. This simple, affordable, sensitive and specific qualitative kit can be used to detect the presence or absence of anti-insulin antibodies within few minutes. This innovation can be a standalone product and also can be multiplexed as subcomponent of an existing diagnostic kit that use similar assay format. Current development status and IP: The proof-of-mechanism has been established using the Guinea Pig anti-Insulin antibodies, and in the process of developing the commercial prototype kit for establishing proof-of-concept using clinical samples. Affigenix has filed the provisional patent application in May 2014 making it the owner of the IP. Market potential and customers: In India 67 million patients are diagnosed with diabetes and invariably they need to test their blood at least 2-4 times a year for rest of their life for Glucose and HbA1c level to assess their diabetes control with drug and life style management. The diagnostics market is expected to grow rapidly in the next few years as there are 30 million people in the pre-diabetes group. Nearly ~7 million diabetic patients depend on insulin injection. The company's main market segment would be doctors at private and government hospitals, clinics, diabetic centres, government primary health centres, health camps and clinical laboratories who would prescribe to diabetic patients on testing for anti-insulin antibodies along with Glucose and HbA1c levels. Other market segment would be insulin and analogue manufacturers and marketers who might promote the use of companion diagnostic by doctors to switch patients to interchange brands or substitute to other analogues. Competition: To the best of our (Affigenix) knowledge, there is no commercially available IVD kits that are capable to detect the presence of anti-insulin and insulin analogue specific anti-drug antibodies. Customized, validated cell-based NAb assays have been used by all Insulin manufacturing companies as part of immunogenicity assessment during their preclinical and clinical trials. ]]> <![CDATA[India's first NABL accredited aquaculture pathology lab]]> https://biospectrumindia.com/news/95/4758/indias-first-nabl-accredited-aquaculture-pathology-lab.html https://biospectrumindia.com/news/95/4758/indias-first-nabl-accredited-aquaculture-pathology-lab.html Wed, 04 Jun 2014 16:22:00 +0530 Rajiv Gandhi Center for Aquaculture, the research and development arm of Marine Products Export Development Authority (MPEDA) established a state-of-the-art Central Aquaculture Pathology Laboratory in its headquarters at Sirkali, TamilNadu in September 2011. The laboratory has been serving the aquaculture industry of the country by providing timely and reliable diagnosis for various diseases encountered during the culture of finfish, shrimps and freshwater prawns. The laboratory is equipped with all the latest diagnostic tools and has three component units for molecular pathology, histopathology and microbiology. The three together help in the diagnosis of various diseases encountered by the aquaculture industry. The molecular pathology laboratory has been routinely engaged in the screening or diagnosis of 16 Crustacean (shrimp or crab) pathogens including World Organization for Animal Health (OIE) listed pathogens besides the three from finfish. In addition, the laboratory conducts periodical and need-based aquaculture disease surveillance in India for the benefit of the seafood export industry. All the known diseases affecting the shrimps, crabs or fish are diagnosed at this laboratory, which includes the recently emerged dreaded shrimp disease viz. Early Mortality Syndrome (EMS) or Acute Hepatopancreatic Necrosis Disease (AHPND). The laboratory has been successfully participating in proficiency testing conducted by the Aquaculture Pathology Laboratory, University of Arizona, USA (a OIE reference laboratory for crustacean diseases). ]]> <![CDATA[Evolva to develop Malaysia's natural products]]> https://biospectrumindia.com/news/95/7821/evolva-to-develop-malaysias-natural-products.html https://biospectrumindia.com/news/95/7821/evolva-to-develop-malaysias-natural-products.html Wed, 04 Jun 2014 15:24:00 +0530 Mr Murali Muthuswamy Panchapagesa, managing director, Evolva Holdings said that the firm is partnering with two Malaysian organizations, to develop sustainable production methods for Malaysian natural products. Mr Panchapagesa said that Evolva will collaborate with Universiti Malaysia Pahang (UMP) and establish a scientific center of excellence for manufacturing natural products as part of the Flavor and Fragrance Cluster in the state of Pahang. The team would focus on developing natural compounds using Evolva's yeast fermentation production platform. With the partnership, Evolva Holdings expects to establish a link between science and business. The abundant natural resources of Malaysia can be developed into high purity ingredients, which then could be used in cosmetics, pharmaceuticals and other industries Mr Murali added further. The first program to be focused on is the production of agarwood fragrances via yeast fermentation. This is to help Malaysians widen the use of agarwood, a highly priced product, used by incense and perfume makers worldwide. Agarwood has recently fallen into the endangered species list updated by the Convention on International Trade in Endangered Species of Wild Fauna and Flora (CITES). UMP vice chancellor, Prof. Nasir Ibrahim said that the partnership was a interesting venture and that the scientific facilities and growing talent in UMP would be instrumental in adding value to the research. Mr Neil Goldsmith, chief executive officer, Evolva, said, "We are looking at generating positive economic and environmental benefits for all, and are delighted to participate in this venture in Malaysia. We are keen on working with young talented scientists in UMP and culminating our research into something of benefit for the society." ]]> <![CDATA[Venus gets European patent for antibiotic drug]]> https://biospectrumindia.com/news/95/3816/venus-gets-european-patent-for-antibiotic-drug.html https://biospectrumindia.com/news/95/3816/venus-gets-european-patent-for-antibiotic-drug.html Wed, 04 Jun 2014 11:22:00 +0530 The GLP accredited research centre of Venus Remedies, Venus Medicine Research Center has received another patent for a novel antibiotic product VRP008 consisting of carbapenem and a novel amino glycoside (NCE entity) from EPO. This product is the outcome of eight years of research by Venus Medicine Research Centre, pioneering it into antimicrobial resistance research. "We, at VMRC, have been working dedicatedly to provide an effective and affordable solution to the compounding problem of anti-microbial resistance ever since we recognized it more than 10 years ago. The sincerity and hard work of our team is reflected in the patents we have received from all over the globe for our novel antibiotic entities such as Elores, Potentox, Vancoplus and VRP008 (the research code for this AAE). Once launched, VRP008 will be one of the best solutions for ICU infections," said Dr Manu Chaudhary, joint managing director cum director research, Venus Remedies. The product is designed for mixed multi-drug infections among pediatric, geriatric and adult immuno-compromised patients where the risk of adverse reactions is high and very low amount of doses are required. It is expected to capture a wide range of market sector, which is beneficial for antibiotics with wide applications. Presently, at least 25,000 people die each year in the European Union from infections due to ESKAPE pathogens which are multi-drug-resistant organisms. The economic impact is estimated at â‚¬1.5 billion per year. Infections caused by these antibiotic-resistant bacteria resulted in approximately 2.5 million extra hospital days annually in Europe. As per the company, the product has been developed by following stringent international guidelines defined for developing a new drug and has undergone pre-clinical studies such as acute toxicity, sub acute toxicity, intravenous and para venous toxicities as per OECD guidelines. Efficacy and Safety rules were established through a series of microbiological studies carried out as per CLSI guidelines. Apart from these, stringent stability studies on all the four conditions including reconstitution stability have been carried out. In 2009, the global anti-infectives market generated revenue of $79.12billion for 12 months till the second-quarter, 2009. Over this period, the systemic antibacterial market accounted for 46.9 percent of this market segment reaching $37.14 billion in revenue. The total worldwide revenue for systemic antibacterials drugs for 12 months till the second quater was $37.14 billion. Overall growth for the forecast period from 2009 to 2024 is estimated to be 6.76 percent (CAGR) rising to a figure of $99.13 billion. Besides this, Venus has also received an EU patent for its novel products Elores, Potentox, Vancoplus and Achnil. ]]> <![CDATA[Syngene, BMS extend collaboration by 5 years]]> https://biospectrumindia.com/news/95/3639/syngene-bms-extend-collaboration-by-5-years.html https://biospectrumindia.com/news/95/3639/syngene-bms-extend-collaboration-by-5-years.html Tue, 03 Jun 2014 16:57:30 +0530 Since 2007, Bristol-Myers Squibb has been working with Syngene and its corporate parent, Biocon, to develop integrated capabilities in medicinal and process chemistry, biology, biotechnology, biomarkers, drug metabolism and pharmacokinetics, analytical research, and pharmaceutical development at the Biocon Bristol-Myers Squibb Research Center (BBRC) in Bangalore. Commenting on the new agreement, Mr Peter Bains, director, Syngene International said, "We are extremely delighted to extend our discovery and development partnership with Bristol-Myers Squibb for another five years. This extension reflects the strength of our existing collaboration which has delivered many successful outcomes. The scope of Syngene's engagement has expanded to encompass a broad range of integrated service offerings across the drug discovery and development continuum. We remain committed to supporting Bristol-Myers Squibb in their pursuit of developing new and innovative medicines for the future." The US-India collaboration has produced six drug candidates for further study and also helped BMS reduce the time and costs associated with advancing new compounds to first-in-human studies. One drug candidate currently in clinical trials was discovered at BBRC, and early non-clinical development work done at BBRC has enabled most of Bristol-Myers Squibb's small molecule assets to advance to later stages of development over the last five years. Mr Francis Cuss, executive vice president and chief scientific officer, Bristol-Myers Squibb said, "I am excited about the opportunity to continue our highly productive collaboration with Biocon and Syngene. The BBRC has supported the non-clinical development of a large proportion of our small-molecule portfolio assets since its inception, and is a premier example of the high-quality innovative drug hunting that is taking place in India today." Bristol-Myers Squibb and Syngene jointly developed the BBRC at Biocon Park in Bangalore. Over the years, BBRC has become Bristol-Myers Squibb's largest research and development center outside the United States, housing more than 400 scientists. ]]> <![CDATA['Lalima': A cloned calf born at NDRI]]> https://biospectrumindia.com/news/95/5760/lalima-a-cloned-calf-born-at-ndri.html https://biospectrumindia.com/news/95/5760/lalima-a-cloned-calf-born-at-ndri.html Tue, 03 Jun 2014 15:12:00 +0530 The female cloned calf named 'Lalima' produced through the 'Hand-guided Cloning Technique' was born on May 2, 2014. The calf was born by normal parturition, and its weight at the time of birth was around 36 kg. It is a clone of an elite Murrah buffalo (MU-5345) from the National Dairy Research Institute (NDRI) livestock farm. The team of scientists involved in the production of this calf include Dr S K Singla, Dr M S Chauhan, Dr R S Manik, Dr P Palta, Dr Shiv Parsad and Dr Basanti Jyotsana. As per NDRI, there are two ways in which the cloning technique will be very useful to dairy sector practically, for faster multiplication of superior germplasm-(i) through males by producing a clone of progeny tested bulls and (ii) through females by producing a clone of high yielding lactating females. In the case of Lalima, the donor cell was taken from the ear of an Murrah buffalo, which produced 2,713 kg milk in a standard lactation period of 305 days and 3,494 kg in a total lactation period of 471 days, during her 3rd lactation. It is also interesting to note that the calf went through the standard gestation period and was born through normal parturition without any assistance, and had normal birth weight. Dr S Ayyappan, secretary, DARE and director general, Indian Council of Agricultural Research (ICAR), New Delhi congratulated the team and said that this new achievement of producing a cloned calf from an adult lactating animal by the "Hand-guided Cloning" technique will facilitate faster multiplication of elite germplasm and help us face the challenges of increasing demand for milk. Dr A K Srivastava, director, NDRI, emphasized that this technology could go a long way in multiplying the number of high milk yielding buffaloes in India. He said that although the world's largest population of buffaloes is in India, contributing about 55 percent of the total milk production in the country, the number of elite buffaloes is not laudable and there is an urgent need to enhance the population of elite buffaloes. ]]> <![CDATA[Quintiles enlisted in Fortune 500]]> https://biospectrumindia.com/news/95/3481/quintiles-enlisted-in-fortune-500.html https://biospectrumindia.com/news/95/3481/quintiles-enlisted-in-fortune-500.html Tue, 03 Jun 2014 11:46:45 +0530 "Being named in the Fortune 500 is a significant milestone in Quintiles' history," said Mr Tom Pike, CEO, Quintiles. "We operated as a private company for a full decade before returning to the public markets via IPO in 2013. Our inclusion in the Fortune 500 is another indicator that Quintiles is one of the most important companies, headquartered in the United States, conducting business in 100 countries," he added further. Companies considered for the Fortune 500 are ranked by total revenue for their respective fiscal years. Included in the survey are companies that are incorporated in the US, operate in the US, and file financial statements with a government agency. "We come to work every day seeking to help patients and improve our customers' probability of success. making it to the Fortune 500 is evidence that we are indeed on the right path," commented Mr Pike. ]]> <![CDATA[CSIR licenses plant based thermo-stable enzyme ]]> https://biospectrumindia.com/news/95/3414/csir-licenses-plant-based-thermo-stable-enzyme-.html https://biospectrumindia.com/news/95/3414/csir-licenses-plant-based-thermo-stable-enzyme-.html Tue, 03 Jun 2014 09:28:07 +0530 The Council for Scientific and Industrial Research (CSIR), Institute of Himalayan Bioresource Technology (CSIR-IHBT), Palampur, have signed a MoU with its industrial partner, Phyto Biotech, Kolkata, to formalize transfer of technology for the production of unique autoclavable Super Oxide Dismutase (SOD) enzyme, used in cosmetic, food and pharmaceutical industries for end applications like developing anti-ageing creams, extending shelf life of fruits and vegetables, and during cryo-surgery and preservation of organelles respectively. The licensing has brought together the CSIR and the industry to enable commercial production of desired standard SOD so as to create a global niche for the country. The enzyme was discovered by CSIR-IHBT during a survey at an altitude of over 10, 000 ft in the Western Himalayan region from Potentilaastrosangunia, a plant growing under snow cover. Persistent hard work over the years has resulted in the isolation of the SOD gene. Thereafter, a protocol was developed for cloning of the gene in Ecoli. The enzyme thus produced, retained the same unique feature as that of the plant. Applying the knowledge of bioinformatics, the enzyme has been further engineered by introducing a single amino acid mutation to increase its consistency and thermo-stability. The characteristic features of SOD lies in its stability and functionality, ranging from sub-zero to temperatures of more than 40 C with varying specific activity. Owing to its high antioxidant properties and multiple uses, SOD enjoys high demand and price in the global market. ]]> <![CDATA[Simband: a healthy wrist watch]]> https://biospectrumindia.com/news/95/3514/simband-a-healthy-wrist-watch.html https://biospectrumindia.com/news/95/3514/simband-a-healthy-wrist-watch.html Mon, 02 Jun 2014 16:52:00 +0530 Bangalore: Samsung's strategy and innovation team demonstrated a health monitoring, wearable wrist band, called 'simband' at the San Francisco's SFJAZZ center. The simband can measure heart rate, respiratory rate and blood pressure. The support software, which enables the band to pool in data and display it, was also elaborated upon. This was done to ease customers worry and help them understand the methodology and functioning of the band. Mr Young Sohn, president and chief strategy officer, Samsung Electronics said, "It is a measure to ensure that people understand their own health and wellness. This puts the individual in the driver's seat and can help them address their health issues at a faster rate." With around 1.2 billion of the population expected to be in their 60's by 2025, digital health innovation plays an important role as the doctor to patient ratio is low, mainly in developing countries. Mr Sohn further added that Samsung would like to partner with innovators and developers across the globe, to extend this initiative in inventing technologies and more digital gadgets that improve the health of citizens. As an encouragement for innovative startups and various other collaborators in the digital health industry, Samsung also announced a $50 million investment fund, dedicated to stimulate creative approaches to digital healthcare through open Samsung platforms. ]]> <![CDATA[Biogen Idec India launches MS campaign]]> https://biospectrumindia.com/news/95/5946/biogen-idec-india-launches-ms-campaign.html https://biospectrumindia.com/news/95/5946/biogen-idec-india-launches-ms-campaign.html Mon, 02 Jun 2014 16:49:16 +0530 The campaign touched upon the need to provide accurate knowledge about MS, and to enable timely diagnosis and treatment for patients suffering from MS. This year the campaign leveraged social and electronic media to spread awareness about the disease amongst general public in the country. As a part of the campaign, Biogen Idec India supported a live webcast in partnership with The Multiple Sclerosis Society of India (MSSI). Mr Sameer Savkur, MD, Biogen Idec India said, "As we continue our research and development efforts to identify new therapies across the globe, Biogen reaffirms its commitment to MS community in the country by spreading awareness about MS and its management amongst patients, care givers and general public." "Through our patient support initiative, REACH-Access program, we aim to facilitate access to therapy for MS patients in India. As part of program, Biogen Idec India provides free therapy support to patients in line with their income assessment done by an independent third party assessor. Approximately 65 percent of patients registered with the Biogen Idec REACH program have benefitted from the support, as the company is bearing almost 50 percent cost of their therapy along with services like disease education, counselling, medication reminders and injection training for self-injectable therapies," he further added. In celebration of World MS Day and as part of its ongoing mission to support MS patients globally, Biogen announced that it has joined the Sailing Sclerosis Foundation's (SSF) Oceans of Hope project as principal sponsor and official partner. ]]> <![CDATA[DBT announces biotech product awardees for 2014]]> https://biospectrumindia.com/news/95/6580/dbt-announces-biotech-product-awardees-for-2014.html https://biospectrumindia.com/news/95/6580/dbt-announces-biotech-product-awardees-for-2014.html Mon, 02 Jun 2014 16:46:26 +0530 On the basis of the recommendation of the selection committee in its meeting held on May 17, 2014, four nominations have been selected for the Biotech Product and Process Development and Commercialization Awards 2014. The awardees will recieve two lakhs each. Among those who have been selected include Dr Indrani Karunasagar, professor, Department of Fisheries Microbiology, Karnataka Veterinary, Animal and Fisheries Sciences University College of Fisheries, Mangalore. The next award is for the six member team led by Dr Thukkaram Damodaran, senior scientist (Horticulture), Central Soil Salinity Research Institute, Regional Research Station, Lucknow. The rest of the two awards would be given to Dr Vijay Kumar Chaudhary, professor and head, Department of Biochemistry, University of Delhi and a three member team led by Dr Abraham Verghese, director, National Bureau of Agriculturally Important Insects,Bangalore. ]]> <![CDATA[Shasun to focus on global regulatory markets]]> https://biospectrumindia.com/news/95/7387/shasun-to-focus-on-global-regulatory-markets.html https://biospectrumindia.com/news/95/7387/shasun-to-focus-on-global-regulatory-markets.html Mon, 02 Jun 2014 16:40:44 +0530 Bangalore: Shasun pharmaceuticals, an Indian pharmaceutical company aims to focus on formulations manufacturing and marketing in the regulated markets to become a global integrated sector in the next two years. The concern expects the formulations shares to grow around 25 percent by 2016-2017. The company plans to set up its market subsidiary in the US during the current fiscal year. The company has been a manufacturer and supplier of active pharmaceutical ingredients (API) and a contract research and manufacturing services (CRAMS) provider. Mr S Abhay Kumar, managing director, Shasun Pharma said, "The focus is on formulations and launching formulations with API integration from our own production." Mr Abhay Kumar expects the transformation to be completed in the next two years. He also opined that the company is working to get regulatory approvals in the lucrative Japanese market for its formulations where it already has an API base. The pharmaceutical company also plans to expand its formulations base by increasing its capacity of production and manufacturing sites. ]]> <![CDATA[First batch graduates from Biocon Academy]]> https://biospectrumindia.com/news/95/5412/first-batch-graduates-from-biocon-academy.html https://biospectrumindia.com/news/95/5412/first-batch-graduates-from-biocon-academy.html Mon, 02 Jun 2014 12:40:19 +0530 Delivering the keynote address at the event, Dr Kiran Mazumdar-Shaw, chief mentor, Biocon Academy said, "Biocon Academy is the realization of my dream to enable and energize the younger generation to pursue a career in biotechnology, a field with the potential to bring transformative change." She further added, "The graduation of the first batch of the Biocon-KGI program sets the benchmark for a very valuable and impactful partnership. It is a partnership between two organizations committed to the 'Business of Science', a partnership between academia and industry, a partnership between the faculty and students and finally, the coming together of the entire biotech sector to give young minds the opportunity to partake in the journey of transforming India through the power of biotechnology. I encourage all the students to passionately pursue their dream and make a difference in their chosen area of biosciences." The 16 week full-time intensive program comprised of hands-on professional training in areas like molecular biotechnology, biopharma quality assurance and control, CMC regulations, pharmaceutical development, mammalian cell biotechnology, and professional skills development. Students including Shruti Rao, Poonam Mathur and Deepthi Ashok Kumar were awarded Gold Medals for Academic Excellence. And, 12 students were given 'Kudos Awards' for their notable performance during the program. Dr Shelly Schuster, president, Keck Graduate Institute (KGI), USA, said, "It is indeed a proud day for the 30 pioneer students who are completing the inaugural session of the Biocon Academy-KGI certificate program. Their learning from this innovative certificate program was deep and the growth and increase in professionalism was profound. These business-trained science graduates are now ready to better serve the global lifesciences industry through their knowledge, talents and passion." According to Biocon's press release, all of its students from the first batch have been successfully placed. Admissions for the second batch are open until June 9, 2014. The classes for the second batch will commence on June 19, 2014. The Biocon Academy was set up in November 2013, encouraging advanced learning in applied biosciences. ]]> <![CDATA[ICMR seeks research proposal focusing on North East]]> https://biospectrumindia.com/news/95/8293/icmr-seeks-research-proposal-focusing-on-north-east.html https://biospectrumindia.com/news/95/8293/icmr-seeks-research-proposal-focusing-on-north-east.html Fri, 30 May 2014 17:25:04 +0530 The announcement aims at seeking concept proposals in communicable disease research in North-East India such as Vector borne Diseases (Malaria, filaraisis, Japanese encephalitis, dengue, chikungunia, West Nile Virus and resurgence of kala azar); Viral diseases (Hepatitis B virus infection with C, D and A and I circulating genotypes); HIV/AIDS and drug abuse; bacterial infections; diarrheal diseases and parasitological which may be developed into full adhoc proposals on approval. In addition, proposals in areas of non-communicable diseases like cancer, heart diseases, lifestyle diseases, neurology, nephrology, disability, ENT, ophthalmology etc. may also be submitted. Under this initiative, the principal investigator would have to identify the problem and gaps in technology which need fortification and institutes outside the region with which collaboration would be useful. Researchers should focus on the health problems of the NE region and the component of technology transfer should be inbuilt in all collaborative projects, where one of the institutions is from outside the region. Other institutions including agriculture, IIT and universities could also apply for funding from ICMR, provided there is a medical or public health benefit in the proposal. Such proposals could also be in the form of collaborative projects wherein medical colleges can also be provided. The deadline for submission of concept proposals is July 20, 2014. North-eastern India shares international borders with neighboring countries like Bhutan, China, Myanmar and Bangladesh, and being a gateway to South East Asia, attains specific importance for various problems due to emerging and re-emerging of communicable diseases and cross border transmission. The focus of projects in North East are primarily to conduct translational research so as to cater to the health problems of North East India, for the benefit of people and public health welfare. The PI must be from the north-east region of India. ]]> <![CDATA['Engaging Indian companies with Oxford and Cambridge']]> https://biospectrumindia.com/features/95/8429/engaging-indian-companies-with-oxford-and-cambridge.html https://biospectrumindia.com/features/95/8429/engaging-indian-companies-with-oxford-and-cambridge.html Fri, 30 May 2014 17:08:13 +0530 Here is Mr Denis Davies describing what the organization does, their offerings and how they can help Indian companies establish in the UK. Says Mr Denis Davies, "We are looking at increasing the amount of generics being brought in the UK, and at the same time we are also looking at Indian biosimilar companies as a next step. We want to engage Indian companies to do research and collaborate with institution and universities like Oxford and Cambridge. We are also working with Scotland, Wales, and Northern Ireland." According to Mr Davies, companies are introduced where leading research is carried out. "Much of what we do is confidential and the quality of the people doing research is very high. We are spread across the UK, and we'll touch base with Indian companies and help them to find even the very basic of things including location, or even schooling for their children," he observes. He advises that it is crucial to know the local network. "We do market research and talk with our trade advisors and know what is required from the companies. Indian population in the UK is massive. Costs are competitive with the rest of the Europe. London is Europe's regulatory HQ," he states. ]]> <![CDATA['Identifying patients for clinical trials accurately and quickly']]> https://biospectrumindia.com/features/95/5319/identifying-patients-for-clinical-trials-accurately-and-quickly.html https://biospectrumindia.com/features/95/5319/identifying-patients-for-clinical-trials-accurately-and-quickly.html Fri, 30 May 2014 17:00:00 +0530 Here is Ms Maggie Massam describing what the organization does, their offerings and how they can help Indian companies establish in the UK. "In essence, what we do is we collect primary care data and anonymize it ensuring we do not have any personal information about patients, thereby making it research-ready," said Ms Maggie Massam. The data is then made available to pharmaceutical companies, academic institutions and to anyone who wants to do research in drug safety. "What we have done recently is we have all the information which is not personal, but clinical data, and we apply technology so that we can identify patients for clinical trials much more accurately and quickly," she explained. Ms Massam also observed, "We have fantastic resources and great NHS database, coupled with the use of clever technologies to make clinical trials far more trusted and efficient." CPRD is not a commercial organization. "But we do charge. We are a part of UK. The pharmaceutical industry in UK is seen to be quite slow in getting things done. It is an expensive process, but this is a part of the whole new world of getting it all done differently. We will help companies be competitive," she concluded. ]]> <![CDATA[Sun clocks 57% profit in Q4 results]]> https://biospectrumindia.com/news/95/7575/sun-clocks-57-profit-in-q4-results.html https://biospectrumindia.com/news/95/7575/sun-clocks-57-profit-in-q4-results.html Thu, 29 May 2014 17:14:00 +0530 Sun Pharma, India's largest pharma company posted successful fourth quarter results, which saw a surge of 57 percent over last year for the same quarter. This takes the total revenue for the company to Rs 1,587 crore from Rs 1,012 crore in 2013. In a press release posted on the company website, the pharma major, declared that the net profit for the fiscal year 2013-14 was up by 42 percent, clocking Rs 4,044 crore. The company has reported improved international sales, with an increase in the US, its largest market, which rose by 22 percent, showing remarkable increase.The pharma major is in the process of taking over Ranbaxy laboratories, now that the ban on the merger has been lifted recently. A committee has been formed by Sun, comprising of members from both the companies to help smoothen the transition process. But the premier Indian company still has to overcome quality issues in some of its plants that caused the USFDA to ban export into the US. ]]> <![CDATA[GM crops may be considered only if essential: Agri minister]]> https://biospectrumindia.com/news/95/5466/gm-crops-may-be-considered-only-if-essential-agri-minister.html https://biospectrumindia.com/news/95/5466/gm-crops-may-be-considered-only-if-essential-agri-minister.html Thu, 29 May 2014 14:04:00 +0530 "I have spoken to government officials and feel GM technology is important. If it is very essential then, we will implement it," Mr Radha Mohan Singh, the new union minister for agriculture told reporters during his takover of the agriculture ministry. The line is somewhat cautious than his predecessor, Mr Sharad Pawar who openly batted for GM crops. Even Mr Verappa Moily, the previous environment minister too in the last months of UPA-2 government had given green signal to confined field trials of the GM wheat, rice, maize and castor. Mr Singh, it seems is striking a balance between the activists and industry. Moreover, it coincides with the ruling party, BJP's manifesto that asks for more biosafety regulations before a go ahead. Immediately after joining as agriculture Minister, Mr Singh held a meeting with senior officers of all three Departments of the Ministry, who briefed him about different aspects including the preparedness to tackle deficient rainfall during the monsoon season, farm insurance, matters relating to small and marginal farmers, animal husbandry, agricultural research and education. Mr Singh has wide experience as a parliamentarian. This is his fifth term as a Member of Parliament. He has been in a number of parliamentary committees. He has also been active in rural development and welfare of the downtrodden. ]]> <![CDATA[Mangalore suspects MERS case]]> https://biospectrumindia.com/news/95/3811/mangalore-suspects-mers-case.html https://biospectrumindia.com/news/95/3811/mangalore-suspects-mers-case.html Wed, 28 May 2014 15:01:34 +0530 Bangalore: MERS scare swirls up in India, as Karnataka health officials and health minister Mr U T Khader confirmed a suspected case of MERS infection in Mangalore, on Tuesday. The victim, a 63- year old woman had been quarantined in a private hospital. Authorities are awaiting the blood and sputum sample reports sent to National Institute of Biologicals (NIB), Pune for inspection. Following a surge in cases in Saudi Arabia, screening of passengers traveling from the Middle East had begun in airports across the country. The woman had gone to Saudi Arabia on May 11 and returned on May 19, and was found coughing at the airport. She was then advised medical help and MERS checkup. On May 22, she was admitted to the private hospital complaining of fever and cough. She is currently under medical supervision. Health officials await the NIB report for a confirmed conclusive assessment on the case. Mr Khader, however assured that there was no need to sound any alert, nor was there a need to coordinate with health authorities of neighboring states. All the passengers travelling from West Asia are screened for MERS at both the airports. ]]> <![CDATA[Arvind collaborates with SRM university]]> https://biospectrumindia.com/news/95/3810/arvind-collaborates-with-srm-university.html https://biospectrumindia.com/news/95/3810/arvind-collaborates-with-srm-university.html Wed, 28 May 2014 14:24:58 +0530 Arvind Remedies, a leading producer of branded and generic pharmaceutical products has entered into a Memorandum of Understanding (MoU) with SRM University, Kattankulathur, Tamil Nadu to transfer the patent rights to undertake exclusive manufacturing, marketing and commercialization of drugs for Type II Diabetes and Coronary heart disease. These drugs will be first launched in the domestic market, followed by the global market. On this occassion Dr B Arvind Shah, managing director and CEO, Arvind Remedies, commented, "According to the International Diabetes Federation, 382 million people across the world have diabetes, which is expected to rise to 592 million by 2035. The number of people with type 2 diabetes is increasing in every country. In order to curb this disease, we have come up with a new drug that is from a botanical source which ensures zero side effects on the health of the patient. We are expecting this new drug to be available in the market by mid 2015." He further added, "Coronary heart disease is also a common type of heart disease and is killing more than 385,000 people annually. We are happy to share that, we have been successful in developing a new drug, which will help in the treatment of coronary heart disease." The MoU was signed in the presence of honorable Chancellor, SRM University, Dr TR Pachamuthu. Registrar of SRM University Dr N Sethuraman, signed the MoU on behalf of SRM University, while Dr B Arvind Shah, managing director and CEO signed the MoU on behalf of Arvind Remedies, Chennai. ]]> <![CDATA[Industry expects Modi-fied decisions ]]> https://biospectrumindia.com/features/95/3808/industry-expects-modi-fied-decisions-.html https://biospectrumindia.com/features/95/3808/industry-expects-modi-fied-decisions-.html Wed, 28 May 2014 12:43:25 +0530 Often the ministers have been looked at as either promoters of a business friendly environment or the ones who create policy paralysis. For that matter, the Narendra Modi led government from the day one of its office, has exhibited tremendous seriousness and a message that it means business. The bioscience industry that has been dealing with major policy issues from a long time is no doubt excited to see a stable government with perceived business friendly attitude. The mood was visible with this immediate tweet from Dr Kiran Mazumdar Shaw, CMD, Biocon, "We are with you in your mission of unleashing the energy of India. You have the vision and the conviction to make great things happen." In her response, Ms Anu Acharya, founder and CEO of Ocimum Bio Solutions and Map My Genome told BioSpectrum, "Hope that they (Modi government) streamline the process and demand that timelines be met." Most of the industry associations have been excited about the new government and keenly watching as its working style unfolds. Starting with the union health ministry, Dr Harsh Vardhan, its new head, is an expert in the area as he comes from a medical background. He is credited with initiating the Pulse Polio program for the first time in Delhi when he was the health minister. Well that sounds like good news for the vaccine industry as the minister can push the projects that need immediate attention. A major pioneering initiative of Dr Vardhan was his act of implementing WHO's Essential Drug Program, which revolutionized governments' attitude on public health care. Under the concept, maximum budgetary outlay was apportioned to those drugs that are most needed by people. It was henceforth known as the "Delhi Model" and taken up by several foreign countries and at least a dozen state governments in India. The Delhi Society for Promotion of Rational use of Drugs headed by Dr Vardhan had also launched the Healthy City Project, the Hepatitis B Immunization Program and a Delhi Research Centre for Modernized Promotion of Ayurveda. The BJP, in its manifesto has exclusively pointed to Ayurgenomics. Mr Ananth Kumar who is the chemicals and fertilisers minister will be equally responsible for helping frame drug policies. The department of pharmaceuticals is a part of this ministry. Looking at his working style, the pharma industry may expect a quick transition from the period of non-decisiveness. Science too has a doctor The renowned diabetologist from Jammu and Kashmir, Dr Jitendra Singh is the minister of state in the cabinet with an independent charge of science and technology. Known as a proactive person who joined politics for changing the health scenario, he is expected to understand the policymaking for science and technology as well. An author of eight books and a columnist, he will have to take some quick decisions on a few pending appointments, especially for the post of director general of Council for Scientific and Industrial Research (CSIR) and secretary of department of science and technology (DST). He will also have to ensure that the Biotechnology Regulatory Authority of India (BRAI) bill is passed in the parliament. BJP, in its manifesto had praised the fact that Indian advancements in biological sciences are being documented and recognized all over the world. However, it had asked for enough biosafety data and labelling of GM food. The rewarding of innovation and focus on biofuels too was on the agenda of the party. Regulations require a rejigHighlighting his expectations that reflect those of the most in the industry, Mr Balvinder Kang, a well-known farmer said, "The new government should provide farmers access to the latest technology as it is not expensive. We would also like FDI in agri sector because farmers will benefit from it."Therefore, Mr Radha Mohan Singh who has joined the cabinet as the new agriculture minister has a lot of responsibilities to fulfil. Having been elected MP for five times, he has been a member of many standing committees. He has been involved in the Kisan morcha activities of his party and hails from a rural background in Bihar. Therefore, the agriculture ministry seems the best bet for him. However, the agri-biotech industry might have to do a lot of convincing on a couple of issues related to policy and regulations. It would be interesting to know what line of thinking the new minister takes on genetically modified crops. He will have to strike a balance between activists on the one hand, and corporate and product development on the other. Mr Prakash Javdekar, besides being the information and broadcasting minister, has been given the environment ministry. From the day of his joining office, he has talked about balancing environmental and business needs. He cited the importance of industry and regulations being on a equal footing. Given this kind of perception, he is expected to clear the files much faster than his predecessors in the UPA government. Another related industry that involves bioscience is that of food processing. Mrs Harsimrat Kaur Badal who joined as a minister for food processing that controls the nutraceuticals and food regulator, Food Safety and Standards Authority of India, has expressed her excitement at being allotted this ministry. As per reports, she has mentioned that the area remains her interest and she wants to work for the benefit of farmers. While the new group of ministers is being hailed as a powerful team, it remains to be seen how coordinated their moves will be. For certain policy decisions, even an objection from one quarter can scuttle the entire process. However, the good thing about this government is that it has a proactive prime minister with a decisive mandate to act. Know your ministers: â– Dr Harsh Vardhan, minister for health and family welfareDr Vardhan commands great administrative experience. He held the portfolios of education, health and law in the Delhi government between 1993 and 1998. In 1994, on a single day, he organized mass immunisation of 1.2 million children, displaying awesome logistics. The World Health Organisation recognized his contribution to society and awarded him the Director-General's Commendation Medal at a prestigious function held in Rio de Janerio, Brazil, in May 1998. â– Dr Jitendra Singh, minister of state for science and technology (independent charge)Dr Jitendra Singh completed his MBBS from Stanley Medical College Madras (Chennai) and MD (Medicine) from Government Medical College, Jammu. Dr Singh has served as chairman of the National Scientific Committee of Diabetes (RSSDI 2013). Besides, he has so far contributed over five thousand published articles in press including a widely syndicate column "Tales of Travesty", which was published in this newspaper on a regular basis. He is also the author of five books; Elsiver published monograms and over a dozen chapters in various text books of diabetes and medicine for MD students. â– Mr Ananth Kumar, minister for chemicals and fertilizersMr Ananth Kumar is a Member of Parliament and has the distinction of having represented Bangalore South constituency of Karnataka for six times. He graduated in the faculty of Arts (BA) from K S Arts College at Hubli which is affiliated to Karnatak University and later, completed his bachelor's in law (LLB) from J S S Law College affiliated to Mysore University. He has served in the union cabinet of previous NDA government as the minister for Civil Aviation, Sports and Youth Affairs, Culture, Urban Development and Poverty Alleviation. â– Mrs Harsimrat Kaur Badal, minister for food processingMrs Kaur is a graduate from Delhi University and pursued textile designing for three years after college. She has been associated with the 'Nanhi Chhaan' Foundation which works for the rights of the girl child and women empowerment. Her other social activities include running a school for street children in Delhi's Vasant Kunj, supporting old age homes and sponsoring medical treatment for needy children. Before becoming a MP in 2009, Mrs Kaur had led a quiet family life. Despite not having any administrative experience, her political family background and enthusiasm as a young leader is expected to be her positive factor.â– Mr Prakash Javadekar, minister for environment and forestsMr Javadekar has been the spokesperson of BJP. A former banker, Mr Javadekar had his grooming for politics in Akhil Bhartiya Vidyarthi Parishad (ABVP), the students wing of RSS. He was a member of the Maharashtra Legislative Council for two terms from 1990 to 2002 before being elected to Rajya Sabha in 2008. Hailing from Pune, Mr Javadekar, a commerce graduate has also been the party's in-charge of Andhra Pradesh. ]]> <![CDATA[Jaypee Group's foray into the healthcare sector]]> https://biospectrumindia.com/news/95/4319/jaypee-groups-foray-into-the-healthcare-sector.html https://biospectrumindia.com/news/95/4319/jaypee-groups-foray-into-the-healthcare-sector.html Tue, 27 May 2014 17:29:15 +0530 Noida based Jaypee Group, one of India's leading infrastructure conglomerates with diversified interests in hydropower, cement, hospitality and real estate has announced its foray into the healthcare sector with an investment plan of Rs 2,000 crore over the next 3-4 years, to establish a chain of hospitals in North India. Jaypee Hospital, the flagship hospital of the Jaypee Group has been planned and designed as a 1200 bedded tertiary care multi-super-specialty facility and, is being commissioned with shortly 525 beds in the first phase at Noida. It has been established on the fundamental principles of providing patient-centric care, evidence based medicine, ethical practices and value for money. Mr Jaiprakash Gaur, founder chairman, Jaypee Group has envisioned that the healthcare division would emerge as a quality benchmark in the field of medicine. Ms Rekha Dixit, director, Jaypee Healthcare commented, "The demand for quality healthcare is rapidly increasing in India. However, it has not been met by a suitable increase in supply. The Jaypee Group intends to bridge this gap by taking the initiative of creating 5000 quality beds and meet the acute shortage of quality beds in NCR and Uttar Pradesh. Also, we are planning similar facilities in other towns like Agra, Kanpur, Bulandshahar and Sahibabad. Hence, we are creating these mega hospitals which will provide correct medical treatment at the right cost". "Our aim is to provide high quality healthcare delivery with world-class technology and infrastructure in the field of super-speciality services to the masses at affordable prices. We are primarily focusing on Noida and the adjoining areas of Uttar Pradesh throughout the Yamuna Expressway which links Delhi to Agra. There has been a continuous growing demand for quality healthcare services in the northern part of India, and affordability has been a biggest challenge for the society. Hence our emphasis and objective will suit the growing demand and supply and to emerge as the most dominant player in healthcare segment in NCR & Uttar Pradesh" added Dr Vikram Singh Raghuvanshi, chief Executive, Healthcare, Jaypee Hospital. ]]> <![CDATA[GSK seeks approval for umeclidinium monotherapy]]> https://biospectrumindia.com/news/95/3594/gsk-seeks-approval-for-umeclidinium-monotherapy.html https://biospectrumindia.com/news/95/3594/gsk-seeks-approval-for-umeclidinium-monotherapy.html Tue, 27 May 2014 16:33:38 +0530 GlaxoSmithKline has submitted a regulatory application to the Japanese Ministry of Health, Labour and Welfare (MHLW) for umeclidinium (UMEC), a long-acting muscarinic antagonist (LAMA), administered using the Ellipta dry powder inhaler. The New Drug Application(NDA) has been submitted to the MHLW for UMEC monotherapy (62.5mcg), as a once-daily inhaled dry powder maintenance bronchodilator treatment to relieve symptoms in adult patients with chronic obstructive pulmonary disease (COPD). UMEC has recently been granted market authorisation in the US, Canada and Europe, with the approved trade name Incruse Ellipta. Regulatory filings in other countries will take place throughout 2014 and onwards.UMEC is not currently approved in Japan and is not licensed anywhere outside of the US, Canada and the European Union. ]]> <![CDATA[Venus bags additional US patent for Vancoplus ]]> https://biospectrumindia.com/news/95/3552/venus-bags-additional-us-patent-for-vancoplus-.html https://biospectrumindia.com/news/95/3552/venus-bags-additional-us-patent-for-vancoplus-.html Tue, 27 May 2014 15:59:14 +0530 Chandigarh based Venus Remedies has bagged an additional patent for Vancoplus from USPTO. Vancoplus is an antibiotic adjuvant entity, effective against the deadly resistance of Methicillin Resistant Staphylococcus Aureus (MRSA). Developed by Venus Medicine Research Centre (VMRC), the R&D wing of Venus Remedies, Vancoplus is the only solution till date for MRSA with more than 9 percent success rate. Quoting on the patent, Dr Manu Chaudhary, joint managing director, Venus Remedies said, "The patent is valid till 2032. We have already initiated the process for pre-IND meeting with USFDA, and we are quite optimistic about getting a fast track approval for this product as MRSA is under the list of limited pathogens, identified under GAIN act by FDA, and Vancoplus falls in the QIDP category." Venus Remedies already has a product patent for Vancoplus from USPTO, this additional patent with broader coverage for use and method of treatment will be beneficial for the company. The formulation will be commercialized in the US market through technology transfer or outlicensing of exclusive marketing rights route. Vancoplus is a novel antibiotic adjuvant entity, highly effective against MRSA, VISA, hGISA and mixed bacterial infections of gram negative and gram positive pathogens. It is the best and safest option to address such infections. It is also active against different mechanisms of resistance such as Cell Membrane impermeability, Efflux pumps, Biofilms, which no other therapeutic options available, are able to address. It took Venus Medicine Research Centre (VMRC) more than seven years to develop this product, which has received an overwhelming response from the medical fraternity in India, since its launch in the country four years ago and is growing with more than 25 percent CAGR in the Indian market. In USA alone, MRSA is associated with a staggering 90,000 infections and an estimated 19,000 deaths annually. Global Antibacterial Market is slated to reach approx. $64 bn by the year 2018, with a growth rate of 7.5 percent. Vancoplus is segmented in the Hospital Treated Infection Market which is growing at a rate of 2.7 percent by taking the sales of competitor brands in 2013 as addressable market for Vancoplus, which stands at $261 million. "In view of the steep rise in the prevalence of MRSA, VRSA and hGISA infections, Vancoplus will be the need of the hour, due to its high potency against these infections and mixed bacterial infection of gram negative and gram positive pathogens. We have developed Vancoplus to address this unmet need," said Dr Manu Chaudhary, Joint Managing Director, Venus Remedies Ltd, and Director, Research, VMRC. Besides this, Venus has also secured US patent for its novel research products ELORES, Potentox and Achnil. ]]> <![CDATA[IFC's offers $147.5 million to Jubilant Pharma]]> https://biospectrumindia.com/news/95/4928/ifcs-offers-147-5-million-to-jubilant-pharma.html https://biospectrumindia.com/news/95/4928/ifcs-offers-147-5-million-to-jubilant-pharma.html Tue, 27 May 2014 15:08:07 +0530 IFC, a member of the World Bank Group, is lending $147.5 million to Jubilant Pharma, to help them enable better access to quality and affordable pharmaceuticals in underserved markets in India and across the world. Of the total financing package, $110 million is from IFC's own account. The remaining $37.5 million is from IFC's Managed Co-Lending Portfolio Program, which provides additional long-term financing through co-financing partners. The loan will help Jubilant Life Sciences increase its focus on the pharmaceutical sector and strengthen its generic drug manufacturing facilities in India. "We consider IFC a long-term partner with significant healthcare expertise across emerging markets. IFC's contribution goes beyond financing. IFC will also help us strengthen our quality assurance and risk mitigation mechanisms and make the company systems more robust," said Mr Shyam S Bhartia, chairman and managing director, Jubilant Life Sciences. "IFC's long-term financing package will consolidate our entire pharmaceuticals business under Jubilant Pharma and build global competitiveness." "Health is a priority sector for IFC in India. There is an urgent need to expand access to affordable and quality healthcare, especially among low-income communities," commented Mr Vipul Prakash, director, Manufacturing, Agribusiness and Services, Asia Pacific, IFC. "This investment will contribute towards making the Indian pharmaceuticals sector globally competitive, and improve access to affordable medicines among a wider population." ]]> <![CDATA[â€œIndia and Japan have a lot to share and partnerâ€?]]> https://biospectrumindia.com/news/95/6064/india-and-japan-have-a-lot-to-share-and-partner.html https://biospectrumindia.com/news/95/6064/india-and-japan-have-a-lot-to-share-and-partner.html Mon, 26 May 2014 14:39:34 +0530 Dr K VijayRaghavan's keynote 'the challenges of emerging bioeconomy' highlighted few important must dos for India to tackle its hurdles. He opined, "Dealing with intellectual property and clinical trials has been a challenge. The resources in Japan and India are different from each other. It is important that we learn from Japan as 65 percent of Indian population would soon be below 25 years. India, therefore, must work in the right direction." Held recently at Tokyo on May, 14-16, 2014, the BIOtech Japan event and its concurrent show, Personalized Medicine and Diagnostics Expo (IVD Japan 2014) attracted a huge gathering from across Asia Pacific and the globe. Giving a perspective about India, the secretary mentioned, "India has been an open society. Students from India travel to the US for training in various subjects and have been at the forefront of leading key research programs in universities abroad. We are trying our best to bring talent back. India is realizing that we must open our culture to the world. " "The nature's engineering works beautifully. Science works to understand the mechanics of -how does it work? how is it built? how does it get that way? Biotech companies try to find solutions by generating and using data generated by research. I feel that both basic and applied research are important. Integrated data is a must," Dr Raghavan told the gathering that comprised prominent researchers and policy makers from Japan. He further said, "Companies must take communication seriously. Evidence must be brought into policymaking and engaging with people is equally important." "India has to fix its problems not by imitating but by partnering with like-minded countries," he told BioSpectrum's Rahul Koul on the side lines of the event. "The nice thing about our interactions with Japan over the last 30-40 years is that we have built a friendship. So, it is not that we are arbitrarily interacting with them, we are infact interacting with friends. Our collaboration with Tokyo on important programs in various areas is an outcome of that. We must push these collaborations in a big way. We must make sure that Japan is the best destination for Indian students, post docs and vice versa," Dr Raghavan mentioned. (Watch this space for the full interview) ]]> <![CDATA[Ultra-sensitive nano-chip for early cancer detection]]> https://biospectrumindia.com/news/95/5016/ultra-sensitive-nano-chip-for-early-cancer-detection.html https://biospectrumindia.com/news/95/5016/ultra-sensitive-nano-chip-for-early-cancer-detection.html Fri, 23 May 2014 16:52:57 +0530 An international team of researchers led by a ICREA Professor at ICFO Romain Quidant, has successfully developed "lab-on-a-chip" platform capable of detecting protein cancer markers in the blood using the very latest advances in plasmonics, nano-fabrication, microfluids and surface chemistry. This cancer-tracking nano-device shows great promise as a tool for future cancer treatments, not only because of its reliability, sensitivity and potential low cost fact, but also because of its easy carry-on portable properties, which is foreseen to facilitate effective diagnosis and suitable treatment procedures in remote places with difficult access to hospitals or medical clinics. Although very compact (only a few centimeter square), the lab-on-a-chip hosts various sensing sites distributed across a network of fluidic micro-channels that enables it to conduct multiple analyses. Gold nano-particles lie on the surface of the chip and are chemically programed with an antibody receptor in such a way that they are capable of specifically attracting the protein markers circulating in the blood. When a drop of blood is injected into the chip, it circulates through the micro-channels and if cancer markers are present in the blood, they will stick to the nano-particles located on the micro-channels as they pass by, setting off changes in what is known as the "plasmonic resonance". These results are the outcome of the SPEDOC (Surface Plasmon Early Detection of Circulating Heat Shock Proteins and Tumor Cells) FP7 project of the European Commission, coordinated by Prof. Quidant. The project also received generous philanthropic support from Cellex Foundation Barcelona. ]]> <![CDATA[Panacea Biotec to declare results on May 30]]> https://biospectrumindia.com/news/95/5518/panacea-biotec-to-declare-results-on-may-30.html https://biospectrumindia.com/news/95/5518/panacea-biotec-to-declare-results-on-may-30.html Fri, 23 May 2014 14:10:11 +0530 All eyes will be on the board of directors of Panacea Biotec, expected to meet on May 30, 2014, to consider and approve the audited financial results for the financial year 2013-14. The company has not been able to do well in the recent past due to huge losses in revenue. The same happened owing to cancellation of UN vaccine progrm supply due to alleged quality issues. It is also being understood that in view of losses, the board will not be able to recommend any dividend in the meeting. Also, in accordance with the SEBl (Prohibition of Insider Trading) Regulations, 1992 read with the Company's Code of Conduct for Prevention of Insider Trading, the trading window of the company shall remain closed for the promoters, directors, officers and designated employees of the company from May 20, 2014 to May 31, 2014 (both days inclusive). ]]> <![CDATA[GSK to freeze vaccine prices for GAVI Alliance ]]> https://biospectrumindia.com/news/95/4677/gsk-to-freeze-vaccine-prices-for-gavi-alliance-.html https://biospectrumindia.com/news/95/4677/gsk-to-freeze-vaccine-prices-for-gavi-alliance-.html Thu, 22 May 2014 14:54:00 +0530 Bangalore: GSK announced that it will freeze the prices of its vaccines for five years for developing countries that graduate from GAVI Alliance support. By committing to offer GAVI Alliance prices for vaccines against pneumococcal disease, rotavirus and cervical cancer, GSK will support developing country governments as they transition to financing the full cost of their local vaccination programs. Since its formation in 2000, the GAVI Alliance has helped to fund the immunisation of 440 million children in some of the world's poorest countries. GSK is a long-standing partner of the Alliance and reserves its lowest prices for GAVI-eligible countries, which can be as low as one-tenth of the prices in developed countries. Speaking recently at a European Commission-GAVI Alliance event in Brussels, Sir Andrew Witty, chief executive officer, GSK paid tribute to the GAVI Alliance leadership and its partners including governments, donors, charities and vaccine manufacturers which together have enabled millions of children in the world's poorest countries to receive innovative, life-saving vaccines. Sir Andrew Witty said, "The achievements of the GAVI Alliance are remarkable with 6 million lives saved since its formation in 2000. Successful vaccination programs have no doubt also helped countries to develop in this time. For countries that are doing well and are moving out of GAVI, I'm pleased that we are able to offer governments a price freeze to help ensure that children continue to be protected by national immunisation programs. At the same time, GSK remains fully committed to supporting GAVI to expand and accelerate access to vaccines for children in the countries that still require the support of the Alliance." With 22 countries graduating, GAVI can now focus resources on the poorest countries, while enabling governments to take increasing responsibility and ownership for vaccination programs over time. GSK is the first company to commit to maintaining lowest prices for five years as countries take this step, enabling governments to plan for financing the full cost of their immunisation programs. "Sustainability is a central pillar in the long-term success of GAVI Alliance-supported vaccine programmes," said Dr Seth Berkley, chief executive officer of the GAVI Alliance. "GSK is taking strong steps towards supporting developing countries whose growing economies mean they are no longer eligible for Alliance support and is leading the way in longer-term access to low prices for rotavirus, pneumococcal and human papillomavirus vaccines for these countries." GSK is one of the largest contributors of vaccines to the GAVI Alliance, supplying innovative vaccines, such as those for rotavirus, pneumococcal disease and cervical cancer, at significantly reduced prices to help accelerate access in developing countries. GSK has committed to provide more than 850 million vaccine doses that will help protect up to 300 million children and young girls in the developing world by 2024. GSK delivers over 2 million vaccines each day; over the period of a year, 80 per cent of the vaccine doses go to developing countries. ]]> <![CDATA[ Compounds active against MERS coronavirus found]]> https://biospectrumindia.com/news/95/3797/-compounds-active-against-mers-coronavirus-found.html https://biospectrumindia.com/news/95/3797/-compounds-active-against-mers-coronavirus-found.html Thu, 22 May 2014 14:47:04 +0530 Clinicians treating patients suffering from Middle East respiratory syndrome (MERS) currently have no drugs specifically targeted to the MERS coronavirus (MERS-CoV), a virus first detected in humans in 2012 that has since caused 614 laboratory-confirmed infections, including 181 that were fatal, according to the World Health Organization. The case count escalated sharply in the spring of this year, and the first cases in the United States were announced in early May. To address the urgent need for therapies, researchers supported by the National Institutes of Health screened a set of 290 compounds already approved by the U.S. Food and Drug Administration or far advanced in clinical development for other indications to determine if any might also show potential for working against MERS-CoV. From the group of 290 compounds, the scientists identified 27 that, in test tube experiments, showed activity against both MERS-CoV and the related SARS coronavirus. These included compounds that inhibited the viruses' ability to enter and infect cells. The active compounds belong to 13 different classes of pharmaceuticals, including drugs normally used to treat cancer and psychiatric conditions, and provide leads for continued study in animals and potentially for study in people. "Given development times and manufacturing requirements for new products, repurposing of existing drugs is likely the only solution for outbreaks due to emerging viruses," the investigators noted in the paper, published in the Antimicrobial Agents and Chemotherapy journal. The research was a collaboration between investigators at the National Institute of Allergy and Infectious Diseases (NIAID), a part of the National Institutes of Health, and Dr Matthew B Frieman, PhD of the University of Maryland School of Medicine in Baltimore. ]]> <![CDATA[ICMR to promote best indigenous TB detection kits ]]> https://biospectrumindia.com/news/95/3799/icmr-to-promote-best-indigenous-tb-detection-kits-.html https://biospectrumindia.com/news/95/3799/icmr-to-promote-best-indigenous-tb-detection-kits-.html Thu, 22 May 2014 14:38:14 +0530 DBT and ICMR, ministry of health and family welfare (MOH & FW) have taken the lead for promoting "Indigenous diagnostic technologies for diagnosis of TB and MDR/XDR-TB" developed by Indian scientists or companies. Under this joint initiative, an 'Expert Group' has been constituted under chairmanship of secretary of DHR and DG, ICMR which evaluates the potential TB diagnostic kit and till now, a total of six meetings have been held and two diagnostic tests have been shortlisted for validation. The aim of these meetings is to connect the companies to the Government as public private partners between the Government, academic institutions and industry. The ICMR has asked the scientists, companies and the researchers working in this area to send the details of their diagnostic kit(s) in the given format to ICMR. The researchers and companies can work on developing cheap, point of care test with molecular technologies for use in programs in PHC's, CHC level, in district microscopy centers under RNTCP. The technology that picks up the maximum number of mutations and provides a result in one day and is cost effective would be preferred. As per ICMR's circular, "There is a need for better kits for the detection of TB-MDR/XDR TB under the program. There are various indigenous technologies developed by Indian scientists for detection of MDR/XDR TB and these technologies are in advanced stages of development and need support and partnerships from government and industry to enable commercialization. It is important to identify the best technologies based on defined parameters and then pick them up for commercialization without losing time. The objective of this initiative is to learn the status of Indian indigenous technologies developed by Indian researchers and discuss the way forward so that these can be made available or commercialized for larger use." "It is the time to push Indian technologies forward and the government is committed to provide financial support for the validation of these technologies in a collaborative manner. MOH and FW will extend full support to take these technologies forward if they are ready, cost effective and are found to be suitable for use in the program as per the recommendations of the committee. The funds for external validation would be provided by DBT/ICMR/DHR and the external validation would be carried out in a multicentric manner," concluded ICMR. ]]> <![CDATA[Solve Ranbaxy merger case in two days, SC tells AP high court]]> https://biospectrumindia.com/news/95/3813/solve-ranbaxy-merger-case-in-two-days-sc-tells-ap-high-court.html https://biospectrumindia.com/news/95/3813/solve-ranbaxy-merger-case-in-two-days-sc-tells-ap-high-court.html Wed, 21 May 2014 12:42:00 +0530 Now there is another twist to the interesting tale of merger of once powerful indigenous company, Ranbaxy by Sun Pharmaceutical Industries. The Supreme Court of India has asked the Andhra Pradesh high court to solve the case within two days. Sun Pharma had last week on 13th May moved the Supreme Court on against a stay on its merger with Ranbaxy Laboratories by the Andhra Pradesh high court. The SC however refused to stay the hearing altogether. In a statement to the BSE exchange, Sun Pharma had earlier mentioned, "We further state that there is no material impact of the matter on the process of the merger of Ranbaxy with our company." In its order on April 25, AP high court had ordered an interim status quo on the $4-billion deal, after a suit from some individual investors alleged insider trading in Ranbaxy's shares by Silverstreet Developers, Sun's wholly owned arm, before the deal was announced on April 6. Two investors in the drug makers had requested the court to direct the Securities and Exchange Board of India not to approve in principle the merger. They had also sought a probe by Sebi, BSE and the National Stock Exchange in the alleged stock trading. Sun Pharma has denied the charge and said the arm's share purchase was being annulled. ]]> <![CDATA[World bank appreciates India's agri power]]> https://biospectrumindia.com/news/95/3814/world-bank-appreciates-indias-agri-power.html https://biospectrumindia.com/news/95/3814/world-bank-appreciates-indias-agri-power.html Wed, 21 May 2014 12:30:00 +0530 While addressing the gathering at NAIP Agri Innovation Conclave 2014 as chief guest, Mr Onno Ruhl, country director for India, World Bank appreciated that India is transforming fast, especially in the agricultural sector, meeting the enhanced demand of food and nutrition successfully. But, India has the potential to become a modern and developed country in near future that can be achieved through the route of agriculture and allied activities. He emphasized that now Indian farmers are also taking up various on-farm and off-farm enterprises to become entrepreneur that is raising their income significantly. Mr Ruhl expressed his happiness over the successful partnership of World Bank with NAIP-ICAR and hoped that it will continue with the forthcoming National Agricultural Education Project on which World Bank is working vigorously. Earlier, Dr S Ayyappan, secretary, DARE and director general, ICAR welcomed the dignitaries and elaborated upon various innovations and technologies that helped farmers to gain prestige and profitability. He said that Indian agriculture has attained sustainability through good science and technology that has permeated to fields and farms. NAIP has brought a change in the mindset of Indian farmers who are now more eager to adopt new technologies and many of them have become innovators as well, he said. Dr Ayyappan emphasized that ICAR implemented NAIP in a mission mode and contemplates to continue the same spirit with various technological and financial initiatives. Dr William D Dar, director general, ICRISAT expressed his sincere thanks to NAIP-ICAR for a long and fruitful partnership and hoped that it will continue in coming years. He showed satisfaction over the mentoring and handholding of agripreneurs that led to prosperity and progress in the Indian agriculture and also enhanced human dignity. Dr Peter Kenmore, FAO representative in India stressed on creation of off-farm rural jobs to increase income and ensure livelihood security in rural India. He said farmers need a scientific support system to meet their livelihood goals and expressed his happiness over the role of KVKs in providing the same. Dr Kenmore suggested that women should be involved in all innovation processes through training and other supports. Dignitaries honored winners of the Agri-Biz Idol contest with cash prize of Rs one lakh and certificate and also felicitated participants of the contest. Farmers and entrepreneurs Yatris of Krishi Parivartan Yatra were also felicitated by the dignitaries. Dignitaries also inaugurated Expo arranged to showcase NAIP innovations and technologies. NAIP's Agri Innovation Conclave is to encourage active participation from the public and private sector in promoting innovations, partnership and entrepreneurial climate in the Indian agricultural sector. This Conclave is a culmination of two major initiatives: The Agri Biz Idol Camp, with top 10 promising agri-entrepreneur youth and The Krishi Parivartan Yatra, which brings together NAIP's 50 most innovative farmers and agribusinessmen of the country. The yatra was organized by NAIP-ICAR for sharing innovations and success stories of the farmers across seven states. Former National Directors, DDGs, Directors of the ICAR institutes, Vice-Chancellors and Senior Officials of ICAR, World Bank, FAO and ICRISAT are participating in the Conclave. The event was jointly organized by NAIP-ICAR and ICRISAT. Dr D Ramarao, national director, NAIP proposed vote of thanks and expressed his gratitude to all partners across the country and to all those who contributed in making the NAIP a successful mission. ]]> <![CDATA['In Sweden scientists own their innovations']]> https://biospectrumindia.com/features/95/4499/in-sweden-scientists-own-their-innovations.html https://biospectrumindia.com/features/95/4499/in-sweden-scientists-own-their-innovations.html Wed, 21 May 2014 11:41:00 +0530 The cooperation in S&T especially the business opportunities in Life Science space, received a boost with the visit of Swedish Minister Ms Ulrica Messing to India in 2005, and the subsequent visit by India's S&T Minister to Sweden, in the same year. This led to signing of MoU between the Swedish Ministry of Education and Research and Indian Ministry of S&T.The agreement was very much in line with the science cooperation agreement India had with EU. These agreements were subsequently followed up few years later by signing up of MoU by the Ministry of Health between both the countries. Following these agreements, the Department of Biotechnology of India, and Sweden's Agency for the Innovation of Science called 'Vinnova', signed science cooperation agreement which focused on tuberculosis research. There was also similar agreement between India's DST & Vinnova, Karolinska Institutet & ICMR among others. "Sweden is ranked as the numero uno country in the world for innovation. The main advantage in Sweden, compared to other countries is that, scientists who makes the innovation, own the Innovation, and not the institution for which they work," says Prof Carani B Sanjeevi, Department of Medicine, Karolinska Institutet, Solna, Sweden, and Senior Advisor, Business Sweden-Invest, Stockholm, Sweden. This is unique and quite different from other countries in the world like the US or the UK, where the institution or the university own the discovery made by the scientist. "There are systems put in place that helps scientists to make their discovery into an IP (intellectual property), and then turn the IP into a company. The company is usually housed in science parks or incubation centers within the University for its Growth," adds Prof Sanjeevi. Vinnova, as well as other agencies like Innovationsbron GU Holding provide start-up funds, early growth fund, and after some years by venture capital funds. There are several firms started like this in Stockholm-Uppsala region, Malmo-Lund region in Southern Sweden, in Gothenburg, and in other University towns like Linkoping and UmeÃ¥. These companies could be pharma, biotech, medtech, diagnostic or digital health companies. From an historical perspective, Swedish MNCs like Pharmacia and Astra were born from this model. All these companies and academic environment provide great opportunities for academy-industry collaborations, drug development, codevelopment, in-licensing including acquisition opportunities for Indian companies in pharma and biotech space. Prof Sanjeevi opines that Sweden offers many unique opportunities in life science space as it is said to be a knowledge economy. "A lot of money is invested in creating new knowledge. For example, at Karolinska Institute, being one of the largest medical universities in the world, has an annual budget of approximately USD 1 billion," he comments. This amount of investment makes it perennial source of innovation. Many of these innovations are supported by University created structures like Karolinska Innovations AB, Karolinska Development AB, and Karolinska Science Park among others. Organizations like 'Business Sweden' is responsible for promoting business for the whole country as well as regional business promotion agencies belonging to the regional governments like Stockholm Business Region, Stockholm Science City, Stockholm-Uppsala Life Science, Invest SkÃ¥ne, Gothenburg Business Region and VÃ¤sterbotten Business region, which offer a lot of support. The Business Sweden-Trade in India has also made a directory of Swedish businesses as well as Swedish business in India. "Once Indian businessmen visit Sweden and see the scope, they are usually overwhelmed by what they see in the form of opportunities," concludes Prof Sanjeevi. ]]> <![CDATA[Sun Pharma response to import ban lack sufficient corrective actions: USFDA]]> https://biospectrumindia.com/news/95/6438/sun-pharma-response-to-import-ban-lack-sufficient-corrective-actions-usfda.html https://biospectrumindia.com/news/95/6438/sun-pharma-response-to-import-ban-lack-sufficient-corrective-actions-usfda.html Wed, 21 May 2014 10:05:00 +0530 U.S. Food and Drug Administration said in a warning letter that Sun Pharmaceutical Industries Ltd's response to an import ban on one of its plants lacked "sufficient corrective actions. Report stated that USFDA banned imports from Sun Pharma's Karkhadi plant in Gujarat in March. Sun Pharma failed to ensure laboratory records had complete data and that manufacturing staff had inadequate training and experience, FDA was quoted as saying. The Karkhadi plant, which makes the antibiotic cephalosporin, is one of Sun Pharma's 25 manufacturing plants. ]]> <![CDATA[IAVI reafirms its commitment to AIDS vaccine ]]> https://biospectrumindia.com/news/95/6355/iavi-reafirms-its-commitment-to-aids-vaccine-.html https://biospectrumindia.com/news/95/6355/iavi-reafirms-its-commitment-to-aids-vaccine-.html Tue, 20 May 2014 11:39:00 +0530 "Do you remember the world before HIV/AIDS? Where will you be when the shadow of this disease is finally gone?" asks the statement from IAVI on the occasion of world AIDS day. "We have seen major advances in preventing and treating HIV/AIDS but millions of people are still becoming infected and dying. In East and Southern Africa, 10.5 million children have lost one or both parents to HIV/AIDS. As the number-one killer of women of reproductive age, this epidemic takes an enormous human toll on individuals, families and communities, and an enormous economic toll in terms of healthcare costs and lost productivity," the statement read. For every three people put on treatment, four other contract HIV. And even if sufficient funding materializes to maximize access and adherence to existing treatment and prevention approaches, "best case" estimates are that low- and middle-income countries will still see more than half a million new infections a year come 2050. Adding and successfully implementing a vaccine with 60-percent efficacy could reduce new HIV infections by 25 percent in its first decade and by almost half in 25 years, averting up to 22 million infections, according to modelling by IAVI, AVAC and Futures Institute. Science is closing in on an AIDS vaccine. Researchers daily learn more about how HIV changes in the body and varies by geography; what the potential targets are on this highly elusive and mutating virus; how antibodies and our own T-cells could help prevent and even clear HIV infection, and how different vectors might be used to make a future vaccine more effective and longer-lasting. Studies are being prepared to build on the landmark RV144 vaccine trial; other exciting breakthroughs are advancing development of second-generation vaccines with even higher, longer-lasting and broader efficacy, and many new candidates are entering early development. A vaccine will be transformative for so many people, cutting through barriers of stigma and gender inequity that stand between many individuals and the power to protect their own health. Yet global spending on AIDS vaccine research and development has been flat in recent years, despite the promising scientific advances. Sustained commitment will be critical to translating today's and tomorrow's promising science into a rich pipeline of vaccine candidates with the best chance of success. "This World AIDS Vaccine Day, we stand proudly beside our many partners and supporters, and together reaffirm our commitment to finding a vaccine that will help rid the world of HIV/AIDS," concluded the statement. ]]> <![CDATA['CMC can find qualified hospitals for clinical trials']]> https://biospectrumindia.com/features/95/6621/cmc-can-find-qualified-hospitals-for-clinical-trials.html https://biospectrumindia.com/features/95/6621/cmc-can-find-qualified-hospitals-for-clinical-trials.html Tue, 20 May 2014 11:05:00 +0530 CMC is considered to be one of the world's advanced biomedical R&D center. In his exclusive interview with BioSpectrum's Raj Gunashekar, he shares some of the detailed information on companies and the research facilities offered at CMC, along with conducting clinical trials, and also about the future outlook of the biomedical R&D center. Q: Can you comment on the companies at CMC and its facilities? Mr Jiang Peng: As the only national level medical and hi-tech zone with the largest scale and the most complete industrial chain in China. CMC is dedicated to pharmaceutical and biomedical field, which includes R&D, manufacturing, distribution, and healthcare treatment. The major well-known multinational firms in our park are AstraZeneca, Takeda, Boehringer Ingelheim, Chugai Pharmaceutical, Sanofi Pasteur, and Nestle Health Science. Besides, we've had business negotiations with other MNCs as well. Q: What do you have in store for companies who want to conduct clinical trials in China? Clinical trials should be conducted in a qualified three-level hospitals. CMC can help find the relevant hospitals in Jiangsu Province, and even all over China. Besides, there are two three-level hospitals in Taizhou, which are now seeking approval. Once certificated, clinical trials could be held in these two hospitals. Q: Can you discuss on the future outlook at CMC? What can we expect from CMC in the five years?CMC is trying to attract 1000 companies with leading talents gathered in one place working on world-class and national level medical innovation. In the next 5 years, CMC will greatly develop the diagnostic healthcare area, reagent base and medical devices base. The 5th phase pilot plant will see its construction phase complete and put into use for new companies. ]]> <![CDATA[China Medical City: A sneak peak in to the world's advanced biomedical R&D center]]> https://biospectrumindia.com/features/95/6264/china-medical-city-a-sneak-peak-in-to-the-worlds-advanced-biomedical-rd-center.html https://biospectrumindia.com/features/95/6264/china-medical-city-a-sneak-peak-in-to-the-worlds-advanced-biomedical-rd-center.html Tue, 20 May 2014 10:55:23 +0530 Situated in Taizhou city, Jiangsu Province, CMC has developed into a fully-integrated mini city consisting of six functional districts spanning across 30 square kilometers. Taizhou is considered to be an advanced center for research and manufacturing in the pharmaceutical, biochemical and biotechnology. Tracing back to the roots, On February 25, 2010, the Ministry of Science and Technology, the Ministry of Health, the State Food and Drug Administration, the State Administration of Traditional Chinese Medicine of the People's Republic of China, and the Jiangsu Provincial Government formed an alliance to combine strategic efforts towards the development of CMC. CMC is currently the only national level biomedical park co-built by ministries and provincial government in China. Today, there are over 50 pharmaceutical and biological research institutes settled in CMC. The platforms in CMC such as R&D platform for biological macromolecular drug and pilot platform have been put into operations for the last four years. Biopharmaceutical companies could use these platforms for clinical sample production and carry out the Clinical Declaration for phase I, II. Moreover, the Vaccine Engineering Centre, a platform built specially for vaccines, provides a wide range of services including vaccine R&D, pilot process development, sample testing, evaluation of clinical trials, as well as independent PI offices and laboratories to biopharmaceutical (vaccine) companies. Jiangsu Provincial CFDA has set up the only branch office in CMC which could perform the provincial CFDA function. The branch makes a point-to-point application special channel to central CFDA. The institute for drug control, port institute for drug control and medical device testing institute has been set up in CMC, which greatly shorten the time for products to obtain importing and registration approval. Under the support of ministries and provincial government, CMC is the core area for developing biomedical industry in Jiangsu Province. CMC also is the strategic production base for national essential drugs which will benefitCMC products to be included in national essential drug list and healthcare reimbursement list. Meanwhile, Jiangsu FDA vaccine batch release institute will settle down in CMC Vaccine Engineering Center, which will help companies in CMC to reduce the production cost for bioproducts and vaccines, improve testing efficiency, and shorten the time to market. CMC, therefore, offers research platforms, manufacturing facilities, land and intelligence to companies. Besides, CMC also helps companies with clinical trials, product registration and sales. CMC totally consists of 6 different functional districts: R&D district CMC builds platforms for pharmaceutical research and provides services for scientific production for incubation, transformation and industrialization. Manufacturing district CMC provides land and rent standard manufacturing facilities to company that focus on vaccine, biotechnology pharmaceuticals, new chemical medicines, hi-end medical devices, traditional Chinese medicine and healthcare products. Exhibition and trade district This district is built for pharmaceutical and medical products exhibition and trade, technology transferring and conferences. By now, 6,000 square meter facilities have been built and 4 consecutive China (Taizhou) International Medical Expo's (CIME) were held. Healthcare district For the benefits of the health of humans and to transfer as soon as possible, the latest pharmaceutical technologies into clinical use, CMC plans to build specialized hospitals in this district for therapeutics and clinical trials. Education district Since pharmaceutical industry require lots of intelligence, CMC is striving to build this district into a well-known university cluster with distinct features and world-class scientific research and training base. Now many domestic and overseas universities have decided to set branches in CMC to provide talent support to settled companies. Residential & commercial district There are also decorated departments, shops, restaurants and bars in this district. Employees at CMC can live in this district and also tend to enjoy recreational activities. There are established national incubators in CMC, which aid enterprises to develop into high-growth enterprises with low-risk and low-cost. The incubator acts as public service function for SMEs business venturing, overseas student business venturing, overseas personnel venturing, ready-made project incubating and new drug incubation. The total planned incubation area is about 60,000 square meters, in which 38,840 square meters had already been established. About 30,217 square meters are used for enterprise incubating, which takes account of 77.8% of the total area. So far there are about 140 biological & chemical labs, and 120 offices, whose unit area reaches 27,000 square meters. The incubator induces the entering of medical related scientific and technological enterprises, and equips necessary public service facility and apparatus sharing, based on practical needs of incubator. CMC offers business and VIP services aiming at intellectual property of high-growth enterprises, IPO, loan financing, product or technology factoring and market circulation channels. It provides business-series-solutions based on different demand of different high-growth enterprises and follow-up and support after inputting to enterprise data bank. CMC also creates conditions and organizes high-growth enterprises to take part in exhibitions of different specifications. Besides, it promotes the product and brand, expands market impact, enhances brand awareness and improves market covering rate. The Pharmaceutical, biochemical and biotechnology industrial output value for China is RMB 1.87 trillion in 2013. The value for Jiangsu is RMB 264.78 billion, which is 14.18% of entire China. Taizhou value is RMB 61.82 billion, accounting for 23.35% of Jiangsu. Thus, many international and domestic pharmaceutical and biological companies set branches and manufacturing base in Taizhou. CMC has advantages in the application for science and technology funding at all levels including Major New Medicine Innovation and Development Program, Science and Technology Support Program, International Science and Technology Cooperation Program, Innovation Funds for Small and Medium-sized Technology-based Enterprises and Torch Plan. Jiangsu provincial leaders visit CMC for investigations repeatedly, to plan and guide CMC development and help coordinate and resolve the major problems in CMC. For biotech start-ups needing funding help, they can obtain the government funding as part of the government support, and some may get funded through venture capitalists. There are three affiliated venture capital investment firms and one financing assurance company in CMC. They provide financing services including venture capital investment and guaranteed loans. The affiliated venture capital investment firms have invested in more than 30 projects, totaling about RMB 200 million so far. In the education area of CMC, Nanjing University of Traditional Chinese Medicine, Hanlin College have set pharmacy, pharmaceutical engineering, pharmaceutical preparations and other specialties with pharmaceutical characteristics. The annual enrolment number is about 1,100 and there are over 4,000 students now. At CMC there are integrated technological platforms for drug development. Firstly, the analysis and test platform provides apparatus configuration, analysis method development, standard research, personnel training and standard operation document for chemical and biological R&D enterprises. This platform has been established according to the national and international regulations and standards, which includes two top labs of chemical drug analysis and biological drug analysis. And there are over 90 sets of R&D apparatus, such as HLPC-MS chromatographic instrument with high resolution, atomic absorption spectrometer, Fu Liye infrared spectrometer, fluorogenic quantitative PCR, nucleic acid isolation machine, fermentation cylinder, biological analysis meter, freezer dryer and many more. Secondly, the new preparations pre-production service platforms are solid preparation and freeze-drying preparation workshops. The quality control system have been built wholly referring to the requirements of GMP. The platform provides advanced pharmaceutical preparation technical services for enterprises inside and outside the park, including sustained-release and targeting agents' formulation design, technology incubators, sustained and targeted performance evaluation, preparation process improvement, and pharmaceutical adjuvant development. Thirdly, the Animal Centre lab, which is currently under construction, is a preclinical drug safety evaluation public service platform aimed at providing services to R&D of pharmaceuticals at home and abroad, and provides experimental animal models needed in new drug R&D, toxicological and pharmacological tests, and advisory services for new drug screening for domestic and foreign pharmaceutical enterprises. Fourthly, the medical information resource network public service platform is built in cooperation with Jiangsu Science and Technology Information Institute to provide literature, patents, standards and other types of pharmaceutical sales inquiry, strengthen information sharing between enterprise and pharmaceutical industry, and improve the overall level of pharmaceutical R&D, production and sales. Lastly, the high-end medical equipment service platform provides enterprises settling in the park with R&D, pilot scale production, quality control, inspection and testing, technical training, standard advice, quality system assessment, product registration and other services on high-end medical devices. ]]> <![CDATA[Takeda inks pact to distribute ASKA]]> https://biospectrumindia.com/news/95/6435/takeda-inks-pact-to-distribute-aska.html https://biospectrumindia.com/news/95/6435/takeda-inks-pact-to-distribute-aska.html Mon, 19 May 2014 18:47:00 +0530 Takeda has licensed the patent to Aska for the authorized generic drug. Aska has gained approval from the Ministry of Health, Labour and Welfare, and is currently applying for listing on the National Health Insurance (NHI) Price List for June 2014. Although the complete terms of the agreement have not been disclosed, Aska will launch and promote the drug to healthcare professionals after it is listed on the NHI price list. Takeda will then purchase this drug from Aska, and distribute it to wholesalers. The launch of this drug will help expand Aska's product lineup and increase its presence in the generics pharma sector. This also provides the company with an opportunity to provide patients and healthcare professionals with an AG similar to Blopress. Takeda has said that it recognizes the need for generic drugs while maintaining quality. The company will continue to explore potential business opportunities that will strengthen its position in the market. It will also continue to collect clinical data results of Blopress with a focus on safety evaluation and provide this information to healthcare professionals. ]]> <![CDATA[Is it curtains for AstraZeneca R&D in Bangalore?]]> https://biospectrumindia.com/features/95/3812/is-it-curtains-for-astrazeneca-rd-in-bangalore.html https://biospectrumindia.com/features/95/3812/is-it-curtains-for-astrazeneca-rd-in-bangalore.html Mon, 19 May 2014 18:11:00 +0530 Just a month after the dawn of the New Year, AstraZeneca announcing its strategic decision to shut down its 25-year-old, state-of-the-art Avishkar R&D center in Bangalore sent ripples across the lifesciences industry in the country. For, the 200,000 sq ft facility in Hebbal, on the way to the Bangalore Airport is not just another research center. It is the research center that put Bangalore and India on the global biotech map in the early 1980s. The same way setting up the Texas instruments office in Bangalore in 1984 spawned the birth of India's Silicon Valley. The who's who of India's biotech industry have cut their teeth in the AstraZeneca center which was born more than 25 years ago as Astra center. It was born when India opened its doors to the world and set up a corporate research center for the first time since Independence. The AstraZeneca center has been the training ground for India's budding biotech entrepreneurs. More than half-a-dozen biotech companies have been set up by scientists who learnt the rigors of corporate R&D under the watchful eyes of AstraZeneca research heads. So, AstraZeneca is not just another biotech research center. It had an iconic status in India's fledgling biotech industry. Can such an iconic center just close shop, and allow its prized research facilities be demolished to make way for ultra-luxury apartments? At the moment, there are controversies abound as to what should be done to AstraZeneca's prestigious R&D center. Should it be abandoned and left alone without any further action? Or offer this coveted space to land sharks for erecting high-rises and commercial establishments? The 10-acre land housing the R&D center is valued at more than Rs 400 crore. The equipment and other facilities at the campus are worth another Rs 1,000 crore. But it will be an insignificant number in the company's balance which reported revenues of $25.7 billion (Rs 154,200 crore) in 2013. Perhaps, it can be turned into an incubator for future biotech start-ups?Even if it is, who is going to finance and chart-out a stringent plan of action for the up keep of the facility? Should the government stick its head in at this crucial time and come up with a robust plan for encouraging future biotech R&D at the same center? It also raises questions as to whether we have enough qualified personnel who can handle the site safely as it is contaminated with harmful biological debris accumulated over a period of time, in and around the R&D site. What will be the consequences if it is not? The Astra Research Center India (ARCI) in Bangalore was established by Swedish-based pharmaceutical company Astra in 1985. However, in December 1998, UK's multinational pharmaceutical 'Zeneca Group' merged with Astra for a whopping $67 billion, forming today's successful biopharmaceutical giant AstraZeneca. The research center primarily focused on TB and malarial research. Today, drugs with new and novel modes of action are urgently needed for infectious diseases since infectious pathogens are developing strong resistance to antibiotics that are currently available. Dr S Anand Kumar, former director, AstraZeneca Research Foundation India, said, "Many R&D based large pharmaceutical companies world over have stopped pursuing drug discovery research for infectious diseases, since the high investment required cannot be recovered. AstraZeneca India's Avishkar R&D center was built and equipped with state-of-the art facilities for conducting drug discovery research for infectious diseases such as TB, which is relevant to India and other developing countries. It is indeed unfortunate that AstraZeneca which was one of the very few companies pursuing drug discovery for infections decided to shut down the activity including its R&D center in India." An emotional Dr T S Balganesh, a former head of the AstraZeneca R&D center, said it is obviously sad to know about the shutting down of the center. The research center, in the last three decades created a scientific community, environment for many scientists and offered them an opportunity to horn their entrepreneurial skills and emerge as entrepreneurs. The center has a good educational ethos for many skilled and talented scientists who were keen to come back to India after spending years on good research and development in various aspects of drug development. "The center has many milestones and achievements through collaborations in neglected diseases. In my opinion, Indian patients with neglected diseases will be most affected and sufferers with this announcement," Dr Balganesh added. Without classifying the decision as right or wrong, he felt the company could have looked at other options as well such as GSK's open facility model or Novartis Tropical Research Center, Singapore. The company could have discussed its decision of shutting down with government agencies a few years ago. The government has been supportive of taking up new ventures. It could have helped the company, which has been doing excellent work in neglected disease areas, instead of just offering good will gestures. "I personally feel nothing came up from the public sector to cushion the momentum initiated by multinational companies such as Astra Zeneca," Dr Balganesh lamented. A few in the industry believe that this difficult decision by AstraZeneca was based on its global cost cutting on R&D due to 'challenging times'. Another distinguished scientist, Dr Janakiraman Ramachandran, who headed and played a significant role in establishing AstraZeneca's global R&D center, and in its discovering and developing novel therapies for neglected diseases like TB and antibiotic resistant infections is also distraught by the closure move. Dr Ramachandran, who is the current chairman and on the board of directors, Gangagen Biotechnologies, feels that the closure of Avishkar R&D center will leave a big void as the center was addressing significant unmet medical needs in the third world nations. Opines Dr Kiran Mazumdar-Shaw, CMD, Biocon and chairman of Karnataka government's Vision Group on Biotechnology, "As research at AstraZeneca's Avishkar R&D center was focused on infectious diseases, its closure is obviously a big blow to R&D efforts aimed at developing drugs for diseases like malaria and TB, which are endemic in developing countries like India. Given India's enormous infectious disease burden, such closures pose a serious setback to efforts aimed at developing new drugs for neglected diseases of the developing world." It is an indisputable fact that AstraZeneca played a crucial role in turning Bangalore in to a teeming biotech innovation hub in the country. Initially, ARCI was under the watchful care of distinguished scientists like Prof. Dr Ramasheshan, Prof. Dr G Padmanabhan and Prof. Dr CNR Rao. ARCI was initially located in the premises of IISc-Bangalore and then moved to Aranya Bhavan in Malleshwaram, Bangalore. It is noteworthy that, the second chairman of ARCI, Prof. Sune BergfstrÃ¶m, a Nobel Laureate in Physiology and Medicine, played an instrumental role in bringing prostaglandins to India, aiding maternal health. The ARCI was inaugurated by the then Prime Minister Mr Rajiv Gandhi. However, the center was moved to the Kirloskar Business Park in 2000, further expanding in to a 10 acre site with dedicated space of 200,000 sq ft for state-of-the-art laboratory facilities to carry advanced biotech research. This new location gave the R&D center easy access to academic hubs of excellence including National Center for Biological Sciences (NCBS), Jawaharlal Nehru Centre for Advanced Scientific Research (JNCASR) and the Indian Institute of Science (IISc), University of Agricultural Sciences (UAS), Center for Cellular and Molecular Platforms (C-CAMP), and Indian Veterinary Research Institute (IVRI). Scientists who worked at AstraZeneca's R&D center also birthed many of the country's successful biotech start-ups including Gangagen (founded by Dr Ramachandran after he retired from Astra), Enzene (founded by Dr Chandrashekar), Aristogene (founded by Dr Sudha Lingappa), Xcyton (founded by Dr B V Ravikumar) and Cellworks (founded by Dr Santanu Datta), to name a few. Back in the early 80's, when biotechnology was still at a very nascent stage in India, Astra grabbed the attention of many qualified scientists who jauntily relocated to Bangalore to conduct world-class research. Dr Anand Kumar and Dr Ramachandran were always on the scout to establish connections with local scientists and entrepreneurs to facilitate Astra's collaboration in carrying out relevant biotechnology research. Dr Sudha Lingappa, director, Aristogene Biosciences, said, "I would like to mention that Aristogene Biosciences took its genesis in erstwhile Bangalore Genei which was founded by Dr P Babu, and was nurtured by Astra Research Center (Avishkar). AstraZeneca's Center at Bangalore has been a source of advanced scientific expertise. The state-of-the-art laboratory facilities were created in 1987 and constantly upgraded as per the targets of the company. Even though a number of multinational companies and some indigenous groups have made inroads into the highly competitive pharma R&D, AstraZeneca has to be credited for its initiative to establish a research center in Bangalore and take a lead in the Indian R&D sector." Dr Goutam Das, the current COO of industry association, ABLE (Association of Biotechnology-Led Enterprises) was also associated with AstraZeneca for a long time. He later joined Biocon group company, Syngene International and took it to great heights as its first CEO. Dr Anand Kumar further explained, "We do not know if something like this could be made to happen in a way that is workable to all the stakeholders concerned, especially given the fact that all pharmaceutical companies worldwide are going through tough times, and are constrained for cash and so is the government in India." "But with a combination of private philanthropy, public good, corporate generosity, community concern and proactive government - who knows what's possible?" he questions. Now the ultimate question that lies before us is that, is there any way by which this unique facility can be retained and operated for drug discovery and development for infectious diseases? "One thought is, large philanthropic organizations such as Bill and Melinda Gates Foundation, Wellcome Trust, Sir Dorabji Tata Foundation, Tata Trust or any other national or International bodies, may be persuaded to purchase the facility from AstraZeneca and make it available for a fee to research funding agencies such as TB Consortium, Medicines for Malaria Venture, Drugs for Neglected Diseases, and others, to lease out space and equipment needed by research teams to pursue drug discovery research for infectious diseases," opined Dr Anand Kumar. He further stated, "Many of these funding agencies lack physical facilities and capabilities of their own for drug discovery research. With a fully equipped state-of the art facility, they may be able to coordinate their research activities more effectively." However, some industry experts are of the idea that instead of a complete closure of this world-class R&D center, it can be turned into an innovation hub for Bangalore's biotech entrepreneurial ventures, rather than let real estate sharks devour and turn the invaluable land into a luxurious high-rise apartment space. According to Dr Mazumdar-Shaw, the shutdown will not augur well either for established companies or start-ups in this sector. "At a time when India needs to create more jobs and increase investments in R&D, the shutdown of the Avishkar facility sends out a negative message to scientists and investors in drug research," she added. In the past, AstraZeneca has created science parks out of its former facilities, Lund in Sweden, for example. On similar lines, the Avishkar facility could be made accessible for both new and established biotech companies who are looking to expand. Industry experts further believe that the lack of such science parks can be detrimental to the smooth translation of biotech innovation. Several stakeholders including the Karnataka government's Vision Group on Biotechnology, C-CAMP, NCBS, ABLE and DBT are on the lookout for ways to address this issue. "It is highly unlikely that the R&D center will be taken up by Indian or other multinational pharma companies. It is indeed unfortunate that AstraZeneca decided to close this excellent R&D Facility which was the largest R&D Center devoted to the discovery and development of therapies for the control of TB and other tropical diseases, which are generally neglected by pharma companies," explained Dr Ramachandran. Dr Mazumdar-Shaw feels that the Avishkar R&D Center lies in the path of flights and hence the site is unsuitable for high rise constructions. "However, the working plan should be fool-proof against the usual maladies of nepotism, mediocrity, and political interference of government-run institutions," said Dr Sudha. A good number of world-class scientists have been trained, which has benefitted academic institutions and has added a good number of scientists to the pool of Indian researchers. Therefore, its closure would certainly have an impact on the quality of research as well on the quality of scientific human resource. Moreover, start-ups will be deprived of valuable technical support and incubation facilities, which no other R&D center has encouraged. "There is a feeling that a chunk of startups are closing because of stringent regulations. We believe, it could be because of lack of support in the form of guidance in regulatory requirements, technical, legal, IP and support from government. In our opinion, the historic center should be a model incubation center or an advanced R&D center catering to both academic and Industrial requirements whether this happens by government as such or by industry giants," concludes Dr Sudha. Closure of many of India's R&D centers by lifesciences companies is attributed to the stringent Indian regulatory protocols and uncertain measures. "India is fast losing its pride of place as an 'innovation partner' in the world, because of the controversy surrounding clinical trials in the country. In trying to convince the courts of the robustness of the regulatory apparatus governing clinical trials, the health ministry has over-compensated by putting in place a monitoring system that is proving to be a huge deterrent to drug innovation. If the government fails to come up with a rational policy soon, it can have an irretrievable impact on India's ability to partake in new drug development as it will lead to an exodus of innovators from India," commented Dr Kiran. Some talks have taken place between the state government and AstraZeneca for salvaging the facility. The central government too may pitch in when an acceptable solution is worked out. Government is keen to get its hands on the biological research facilities within the center. The facility has a much larger R&D process center which is of great interest to other pharma companies. The last word is not yet out on the iconic AstraZeneca research center in Bangalore. ]]> <![CDATA[Venus gets authorization for meropeneum]]> https://biospectrumindia.com/news/95/5181/venus-gets-authorization-for-meropeneum.html https://biospectrumindia.com/news/95/5181/venus-gets-authorization-for-meropeneum.html Mon, 19 May 2014 18:03:00 +0530 Bangalore: Venus remedies, one of the first companies to have a dedicated EU-GMP-certified facility for manufacturing penems, has received authorization from Australia's Therapeutic Goods Administration (TGA) to market its drug meropenem. The approval has the company eyeing a sizeable share in Australia's $15 million meropenem market. It has tied up with Lupin, an Australian pharma giant to market the drugs in the country. Meropeneum, an antibacterial agent of the carbapenem class of antibiotics that cures infections caused by susceptible bacteria in both adults and children, will be marketed by the third quarter of this year. "The marketing authorisation from TGA has once again proved the company's capabilities in developing world-class products that meet the most stringent regulatory requirements. This is yet another milestone for the company in being able to obtain a significant share in the meropenem market globally. Having established strategic tie-ups to market the drug in countries, we enjoy an edge over other competitors," stated Mr Pawan Chaudhary, chairman and managing director, Venus Remedies. The company is already selling meropenem in highly lucrative markets like Europe, New Zealand and Saudi Arabia, it is also aiming to have its presence felt in the regulated markets of Canada and Switzerland. The company which is among the 10 leading fixed-dosage injectable manufacturers globally, has three manufacturing units, in Panchkula, Baddi in India and Werne (Germany) along with 11 overseas marketing offices, including a presence in the US and Germany. ]]> <![CDATA[Travel storage solution designed to keep Insulin cool launched]]> https://biospectrumindia.com/news/95/5965/travel-storage-solution-designed-to-keep-insulin-cool-launched.html https://biospectrumindia.com/news/95/5965/travel-storage-solution-designed-to-keep-insulin-cool-launched.html Mon, 19 May 2014 17:56:55 +0530 FRIO is capable of changing the life of an Insulin dependent diabetic, especially one who is on the move and has no access to refrigeration or faces power outages while travelling. Unlike traditional Insulin carrying cases, FRIO Insulin Wallet's cooling properties are not derived from an Ice-pack that needs refrigeration. It is easily activated by water. The wallet is an environment-friendly re-usable product. It can conveniently be carried around on oneself or in one's hand baggage. FRIO Insulin Wallet was invented by a first-generation UK-based entrepreneur Garnet Wolsey over 15 years ago. The product was evaluated by the British Diabetic Association in 1999 and was awarded a Millennium product status by the then Prime Minister, Mr Tony Blair. Over the years, the product has become very popular across the world. FRIO Insulin Wallet is an evaporative cooling unit that has been designed to keep in use insulin and other temperature-sensitive medications cool, within safe temperature of 18-26° C for up to 45 hours, in a constant environmental temperature of up to 37.8° C. The wallet can be re-activated every other day for the life of in-use insulin, that is, 28 days. FRIO Insulin wallet carries an affordable price tag and is available in all major metros in India like Mumbai, Pune, Delhi, Bengaluru, Chennai, Hyderabad, Chandigarh and Trivandrum, amongst others. The product is also available for online procurement on domestic health portals. ]]> <![CDATA[Volume rises but value falls for M&A deals]]> https://biospectrumindia.com/news/95/3804/volume-rises-but-value-falls-for-ma-deals.html https://biospectrumindia.com/news/95/3804/volume-rises-but-value-falls-for-ma-deals.html Fri, 16 May 2014 17:18:00 +0530 The challenges posed by expiring patents, the global economic slowdown, and price premium pressures are forcing the pharmaceutical and biotech industry to restructure and streamline strategies to boost profitability. Mergers and acquisitions (M&As) have become the preferred approach to counter low margins as they give access to new markets while creating more revenue pools and, to some extent, compensating for depletion in the research and development pipeline. New analysis from Frost & Sullivan's Merger and Acquisition (M&A) Trends in the Global Pharmaceutical and Biotechnology Industry reveals that oncology, one of the largest and fastest-growing therapeutic domains in terms of drug development, is expected to remain the hot pick for buyers looking to strengthen their portfolio. North America will continue to be the most active region in terms of both number and value of deals. "Big pharma's contribution to M&A deal value has been decreasing, and the trend towards more low-value deals is likely to persist," noted Frost & Sullivan financial analyst Dr. E Saneesh. "However, with a good number of drugs expected to lose patent in the near future, and balance sheets showing more than adequate cash, big pharma will set in motion mega deal activities to replenish its portfolio." Other sectors in healthcare, like diagnostics and medical technologies, will be particularly attractive since they have higher scope for innovation and fewer regulatory hurdles. Acquiring companies in these segments could help drug manufacturers diversify risks in the primary pharmaceutical sector. "The presence of financial investors in deal-making also increased in the first three quarters of 2013, indicating improving investor confidence in the industry," explained Saneesh. "This can lead to joint deals with pharmaceutical and biotech companies that too are on the verge of raising funds for deal-making." Merger and Acquisition (M&A) Trends in the Global Pharmaceutical and Biotechnology Industry (http://www.financialservices.frost.com) is part of the Business and Financial Services subscription. Frost & Sullivan's related studies include: Mergers and Acquisitions Trends in the Global Property and Casualty Insurance Industry, Mergers and Acquisitions in the Internet Software and Services Industry, Investment Opportunity in Fuel Cells, and Private Equity and Venture Capital Investment Trends in the Global Packaged Food Industry. All studies included in subscriptions provide detailed market opportunities and industry trends that have been evaluated following extensive interviews with market participants. Frost & Sullivan's Business and Financial Services group serves clients around the world in all aspects of financial analysis, market research and monitoring, due diligence, idea generation, opportunity analysis, investment valuation, and other proprietary research. ]]> <![CDATA[MedImmune and Incyte announce collaboration ]]> https://biospectrumindia.com/news/95/7234/medimmune-and-incyte-announce-collaboration-.html https://biospectrumindia.com/news/95/7234/medimmune-and-incyte-announce-collaboration-.html Fri, 16 May 2014 15:46:43 +0530 AstraZeneca announced that MedImmune, its global biologics research and development arm, has entered into a clinical study collaboration with biopharmaceutical company Incyte Corporation. The Phase I/II oncology study will evaluate the efficacy and safety of MedImmune's investigational anti-PD-L1 immune checkpoint inhibitor, MEDI4736, in combination with Incyte's oral indoleamine dioxygenase-1 (IDO1) inhibitor, INCB24360. Dr Bahija Jallal, executive vice president, MedImmune, commented "Immuno-oncology is one of the most exciting areas in our industry and we are progressing our strong pipeline as rapidly as possible. Our partnership with Incyte is further evidence of our belief that combination therapies have the potential to be one of the most effective ways of treating cancer." "Research collaborations that evaluate combinations of novel immunotherapies across a broad range of indications have the potential to accelerate our understanding of this rapidly evolving field, to identify new areas of opportunity for immunotherapies, and to more rapidly address the unmet needs of patients with a wide range of cancers," said Mr HervÃ© Hoppenot, president and chief executive officer of Incyte. "For these reasons, we welcome the opportunity to work with MedImmune to explore the potential of combining MEDI4736 with INCB24360." AstraZeneca and MedImmune have recently initiated other immuno-oncology combination trials, including MEDI4736 with IRESSA and MEDI4736 with tremelimumab. Other combination trials are planned to start imminently, demonstrating the strength and rapid progression of the company's immuno-oncology portfolio. ]]> <![CDATA[Dr Kiran Mazumdar first Indian to receive 'Othmer Gold Medal 2014' ]]> https://biospectrumindia.com/news/95/6343/dr-kiran-mazumdar-first-indian-to-receive-othmer-gold-medal-2014-.html https://biospectrumindia.com/news/95/6343/dr-kiran-mazumdar-first-indian-to-receive-othmer-gold-medal-2014-.html Fri, 16 May 2014 14:29:00 +0530 Dr Kiran is the third woman to receive the Othmer Gold Medal, and the first Indian to make it to this prestigious group. The CHF lauded Dr Kiran's pioneering efforts in biotechnology, and for scripting a hugely successful entrepreneurial story by drawing on her knowledge of fermentation science to build Biocon, India's first biopharma company. Accepting the award, Kiran Mazumdar-Shaw, CMD, Biocon, said, "I am deeply grateful to the Chemical Heritage Foundation for awarding me the Othmer Gold Medal 2014. This is an honor akin to being invited to join an extraordinary league of scientists, engineers, entrepreneurs, thought leaders and philanthropists, an emotion that is both proud and humbling at the same time." Established by the Chemical Heritage Foundation (CHF) in 1997, the annual award honors outstanding individuals who have made multifaceted contributions to chemical and scientific heritage through outstanding activity in such areas as innovation, entrepreneurship, research, education, public understanding, legislation or philanthropy. Dr Kiran further added, "As an entrepreneur who is driven by a sense of purpose to make a difference to global healthcare, I take pride in saying that Biocon is contributing to affordable innovation which goes to the core of ensuring a global right to healthcare. In this, we seem to be drawing lessons from Donald Othmer's practical and low-cost approach to innovation." The Othmer Gold Medal is presented annually and co-sponsored by CHF and four affiliated organizations namely the American Chemical Society (ACS), the American Institute of Chemical Engineers (AIChE), the Chemists' Club, and the Societe de Chimie Industrielle. The medal commemorates Dr Donald Othmer (1904-1995), noted researcher, consultant, editor, engineer, inventor, philanthropist, professor, and coeditor of the Kirk-Othmer Encyclopedia of Chemical Technology. So far, nineteen people have been conferred with this honor till date, including Arnold O Beckman, Carl Djerassi, Mary Lowe Good, Harry B Gray, Jon M Huntsman, Kazuo Inamori, Robert S Langer, P Roy Vagelos, James D Watson, George Whitesides and Ahmed Zewail. The Chemical Heritage Foundation (CHF), located in Philadelphia, is a collections-based nonprofit organization that preserves the history and heritage of chemistry, chemical engineering, and related sciences and technologies. The collections are used to create a body of original scholarship that illuminates chemistry's role in shaping society. ]]> <![CDATA[Biocon: A nesting ground for biotech spinoffs]]> https://biospectrumindia.com/features/95/4669/biocon-a-nesting-ground-for-biotech-spinoffs.html https://biospectrumindia.com/features/95/4669/biocon-a-nesting-ground-for-biotech-spinoffs.html Fri, 16 May 2014 11:47:00 +0530 It has added one more feather to its cap by being the nesting ground to churn out new start-ups. It is an informal incubation lab for new spinoffs. Biocon, without any hesitance, is the most sought after company for careers. It was ranked No 6 on the annual Global "Top Twenty Employers" list for the biopharma sector by Science magazine. Biocon is the only Asian company as per Science to be a part of the Top 20 Elite List which includes leading global innovators. What is lesser known is the fact that the company has been a playground for entrepreneurs and entrepreneurial spirit. While BioSpectrum has recognized two of its former top executives, Shrikumar Suryanarayan, who was president R&D, and Ajay Bharadwaj, former president of marketing at Biocon, as BioSpectrum Entrepreneurs of the Year in 2012 and 2013 respectively, for their outstanding performances in their new roles as chairman and co-founder of Sea6 Energy and chief executive officer of Anthem BioSciences, there are almost another two dozen companies that have sprouted. Many of its former scientists and employees who started with Biocon, have today ventured in to becoming full-fledged entrepreneurs with phenomenal success. The lessons and invaluable experience gained at Biocon had played tremendously in steering many start-ups and business ventures in India. Some of them were even influenced to move out on their own through the irrefutable inspiration received from Biocon's CMD, Dr Kiran Mazumdar herself. Dr Arumugam Muruganandam, founder, MD and CSO, Affigenix Biosolutions, pointed out, "In India, against all odds for the past 36 years, Dr Kiran has shown the knowledge, power, and possibilities that biotechnology unlocks. In my opinion, she is a visionary and a great role model for any scientist. Her inspiring speech on how she wants to transform Biocon in to a billion dollar company by 2015 is an unforgettable speech I heard while I was at Biocon." Dr Muruganandam joined Biocon in 2008, as the head of preclinical development team in the R&D division. "At Biocon, I was fortunate enough to work along with a young dedicated and creative scientific team, who were passionately involved in mastering the craft of drug development towards meeting the common company goal of providing affordable and innovative medicine to the world." He says that his prior experience at Biocon has helped him personally to rise above many situations and struggles. "The professional learnings have helped me gain confidence to take risks, and allowed me to venture in to establishing and managing a start-up company," he observes. Speaking about his wide experience at Biocon, he recalled, "Leading a versatile team, managing multiple projects with objectives in a time-bound manner, implementing risk mitigation strategies, alliance management and multitasking are the learnings I had during my four-year tenure at Biocon." "In 2009, I was assigned to build and manage a bioanalytical lab and a team for developing immunogenicity and biomarker assays for some novel biologics and biosimilar drugs under development," he said. In 2012, after a successful and satisfying career at Biocon, Dr Muruganandam voluntarily resigned from Biocon and joined his family business in Chennai. "In 2013, I joined a private start-up company, Affigenix Biosolutions, as the MD and CSO and established the R&D unit in Bangalore," he said. At present Affigenix's scientific team is working on several niche products and biosolutions, and provide contract services for biopharma, leather and petroleum industries. "In the next couple of months we will be filing two patent applications," said Dr Muruganandam. As a wish, he states, "An autobiography by Dr Kiran Mazumdar will inspire many aspiring entrepreneurs and scientists. My wish is that she should pen it for the benefit of future generations. As Audrey Hepburn once said, 'Nothing is impossible. The word itself says 'I am possible'. Dr Kiran is a fine example of that." Mr Subramani Ramachandrappa, CMD, Richcore Lifesciences, is another scientist who joined Biocon in 1999 after graduating in textile technology. "As an enzyme company, Biocon was a major provider of enzymatic solutions for industrial applications of which textile industry was one of the verticals. My first role was to provide technical support to Biocon's textile customers. My immediate superior and senior colleagues gave me sufficient freedom to experiment and go after new applications. This experience helped me think of innovation at a very early stage in my career," added Dr Ramachandrappa. Today, Richcore Lifesciences provides innovative solutions to food, water, energy and biopharma industries. "When I joined Biocon, I was probably the junior-most among a bunch of extremely talented people. The greatest strength of Biocon has been its people put together by Dr Kiran, who were a great hot group of experts, who were fun loving, competitive, passionate and 'intra-preneurial'," he reminiscenced. Dr Ramachandrappa spent close to 2 years at Biocon. "I did not fully comprehend what I really learnt in the short exciting time I spent there. However, Biocon taught me a lot more after I left the organization. I became their sales partner, and was able to support my venture. I was able to understand the nuances of innovation and leadership," he expressed. He further adds, "I learnt that a company will be successful if you develop leadership at every level. Biocon had several leaders, starting from Dr Kiran, going all the way down to the guy who ran the canteen. She has been an inspiration and continues to teach by example." According to Dr Ramachandrappa, he never viewed Dr Kiran as a 'woman entrepreneur'. "To me she was a leader, and she led from the front at all times," he opined. Mr Ramakrishnan Venkataraman, co-founder and head of business development, Nature Biochem, is another entrepreneur who joined Biocon in its marketing and technical services in its enzyme division for the paper and pulp industry. Currently, he is the head of business development at Nature Biochem, known for various enzyme application industries ranging from food to non-food applications. According to him, his greatest learnings from Biocon was taking onus on himself for business development in all aspects, starting from enquiry generation to customer fulfillment. "I also learned about targeting opportunities for business development through various new product applications. My learning meant that I am confident in taking on any challenge that comes my way. It also motivated me to look out for opportunities to expand my business network professionally, and grow as a leader personally with job satisfaction," he observed. Mr Ramakrishnan recalled that, "While I was with Biocon, the enzyme business for paper and pulp applications grew from 'no business' to being one of the leading revenue spinners for Biocon's enzyme business, when practical application of enzymes in the Indian paper mills was totally unheard of. I cherish this achievement." He says that Dr Kiran inspires everyone with her amazing achievements every day. "She has brought a lot of pride to India for being able to show the world that Indian women and Indian companies are capable of building world-class businesses," he concluded. Interestingly, there are many women too, who went on to establish their own start-ups after a short or long stint at Biocon. Among them is Ms Monisha Hajra, an ex-employee of Biocon who treaded the unchartered territory of entrepreneurship. She is the founder of ScientiaBio, a start-up launched in 2010, focusing on clinical research and trials, and providing cutting-edge training in computational biology, early drug discovery and development. She said, "I obtained my PG diploma in Bioinformatics from the Institute of Bioinformatics and Applied Biotechnology (IBAB). There, I was part of the National Entrepreneurship Network (NEN) which pumped within me much inspiration to become an entrepreneur. I was working with Biocon as a scientist in R&D, which lasted for two-and-a-half years. After acquiring knowledge, new skills and technologies at Biocon, I was looking out for opportunities to become an entrepreneur." She advised, "My mantra for all entrepreneurs is that they need to be innovative and imaginative. It is a hard path. It takes a lot of time and effort. There will be many hurdles, but giving up is not an option." Another noteworthy woman who today is successfully running her own start-up is Ms Gulshan Walia, was formerly heading human resources in Biocon's group company, Syngene. "It was an interesting experience to work with high caliber senior leaders and steer a large organization. The entrepreneurial learnings were from the powerhouse, Dr Kiran herself. She embodies fundamental tenets of success in any sphere of life. Hard work, a never-say-die attitude, and the best part is her zeal to continuously look for new peaks to scale high every day and every moment," added Ms Gulshan. Currently, Ms Gulshan runs Infinitzus Consulting, a human capital consulting venture, an attempt to bridge the gap between 'what is' and 'what could be'. Mr Abhishek Behre is the director and co-founder of Sewarth Healthcare (Simplify Everyday Wellness and Reviving the Happiness in you), an initiative encompassing various health-related aspects ensuring healthy and happy well-being of individuals. At Biocon, he served as the senior brand manager in Diabetology (Insulin Team). "In Biocon, innovation with best practices and community services inspired me the most," said Mr Abhishek, who worked with Biocon for 19 months. Talking on his start-up adventure, he said, "In today's hustle and bustle of life, we have compromised on many aspects of health due to time constraints, hectic schedules and other hardships. This thought motivated me to begin our start-up program in a tier-2 city like Jabalpur, where health awareness is low with the presence of more number of senior citizens." Another entrepreneur is Mr Abinash Saikia, who has co-founded two start-ups, EnCloudEn and SmartBuildings, in the last two years after leaving Biocon. EnCloudEn is a software company in the enterprise space for deploying and managing cloud based IT infrastructure, while, SmartBuildings is involved in developing breakthrough technologies for energy monitoring, analytics and conservation in buildings. His first job was at Biocon after he graduated with an MBA from IIM, Bangalore. "I started looking at entrepreneurship as an ultimate challenge early on, starting from my college days. Working in Biocon elevated that thought process by stimulating my urge. In India, we are blessed to have role models like Dr Kiran Mazumdar-Shaw. This played a big role in me to take up the path of entrepreneurship," added Mr Abinash. Mr Vidyashankar Balasubramanyam was also another ex-employee of Biocon, now the founder, president and CEO of Leaf Cleantech, aimed at providing novel biochemical solutions to industries and industrial applications. "We were incorporated in 2010, where we provide enzymatic and biochemical solutions for various industries," added Mr Vidyashankar. "I always felt that there are lot of opportunities and new challenges that we could tackle. Armed with a background in the enzyme industry, it offers a plethora of solutions which could be commercialized successfully." Talking about his experience with Biocon, he added, "Biocon has always been a different organization, and it promoted 'intrapreneurship'. The management never failed to encourage us to think-out-of-the-box. It also gave us the liberty to approach anyone in the company and discuss ideas and concepts." He observes that planning and executing one's strategy is pivotal. "Funding will always pose issues for the biotech industry. India is just evolving and it is definitely going to be a challenge," he ended. Inbiosys is a project management consulting firm established in October 2013, founded by Dr Ravi Kshirsagar, an ex-Biocon employee, which is focused on providing consulting services to biotechnology and pharmaceutical companies engaged in the development, manufacturing and marketing of chemical and biological products. "We help biotech and pharma companies around the world set up standard project management practices. We also help virtual and mid-sized companies in this area who are located in innovation clusters, by managing their projects on behalf of the sponsors. Lastly, we provide project trainings," added Dr Kshirsagar. "While working at Syngene," he explained, "I gained knowledge on end-to-end visibility about how a business operates including all the pieces and wheels and how they work in sync," said Dr Kshirsagar, who worked at Syngene for two-and-half-years. Cabis Labs was started in 2011 by Dr Rajesh Kavali, who also formerly worked with Syngene. The company provides custom synthesis and manufacturing of chemicals to both pharma and chemical industries. Cabis Labs clientele includes Sigma-Aldrich, Dr Reddy's Lab, Advinus and international companies in countries like Germany and the US. "We always thought of starting our own firm. To be an entrepreneur, one needs to be confident and have an in depth knowledge of the market, and face the funding woes," commented Dr Kavali. In 2007, Mr Tarun M Saxena, CEO, AB Bioproducts (I), founded the company, which is a Mumbai-based biotech venture catering to three verticals, including distillery, pharmaceuticals and food ingredients. "I joined Biocon in 1995 and served there for 15 years. I was hired when Biocon decided to venture in to the pharmaceuticals business. At Biocon, I was in to marketing and providing technical services. I also played an instrumental role in the Biocon's procurement and HR. Back then Biocon had a turnover of Rs 12 crore," recalled Mr Saxena. "However, when I parted from Biocon, its turnover was around Rs 800 crore and I was handling the company's business worth 100 crore. I was part of Mr Ajay Bhardwaj's team at Biocon," he further added. Mr Saxena says that the biggest entrepreneurial lesson he learnt at Biocon was delegating responsibilities. "Dr Kiran was a 'pro' in delegating tasks among the team, and that's precisely why we have become independent entrepreneurs today, which back then instilled confidence within us to do what we are doing today," he cherished. Mr Naveen Jaidka is the founder of the 19-year-old company, Enzyme India. Talking about his venture, he opined, "We are in to manufacturing industrial enzymes for various industries including agriculture, food, textile, ice cream, detergents and leather. We also develop products to treat industrial effluents before they are discharged." Mr Jaidka moved out of Biocon in 1995 and incorporated Enzyme India in January 1996. "At Biocon, I was the production manager. In fact, I and Mr Ajay Bhardwaj joined Biocon together. I was involved in the day-to-day affairs of production, sourcing, cost-cutting and purchasing of raw materials. I was also involved in getting the ISO 9001 certification for Biocon in 1992-93," he remembered. Mr Jaidka said that he always had the spirit of entrepreneur in his heart and mind. "I saw Dr Kiran starting from the very scratch. She inspired us to start on our own as she proved herself in the industry," he commented. Mr Aditya Malhotra, co-owner of CATALYSTS Bio-Technologies also worked for Biocon. The company was established in 2003 in Uttar Pradesh, which was initially started as a channel partner of Biocon. CATALYSTS is involved in manufacturing and marketing of biotechnological enzyme, comprising of about 70-80 employees. "In 2007 we were worth Rs 7-8 crore. Within a span of seven years, the company has now grown to be in the top five Indian biotech companies in India with a turnover of Rs 50 crore. We are now exporting our products to Pakistan, Africa, South-east Asia and China. By 2016 we want to touch the Rs 100 crore mark," said an overjoyed Mr Malhotra. Talking about his stint with Biocon, he expressed, "I was the regional marketing manager up North in Delhi. I joined Biocon in 1997 and worked there for 10 years. Biocon in itself was a big motivation for me to run my own organization today. I ensure that I'll always carry Biocon's legacy forward. I was hardly 31 or 32 then, but the confidence and the belief in me were strong and the experience at Biocon was incredibly supportive to my future venture." According to Mr Malhotra, the biggest entrepreneurial lesson he learnt from Biocon is valuing 'people'. "It is the people who are the company's biggest assets. If you take care of them, then they in turn will take care of the company. Dr Kiran and Dr Ajay Bhardwaj took care of us, and gave us responsibilities and abundant liberty. My 10 years at Biocon itself was an entrepreneurial journey and it started right at Biocon." Today, Mr Malhotra follows the same Biocon culture at his company. "At our company we value people a lot. We allow people to make mistakes and let them fall and grow in their journey. One day I wish to see all my employees become independent entrepreneurs," he said. In India, Biotechnology has huge potential. And it is very interesting to see that over two dozen companies have been formed in diverse areas ranging from enzymes to trading, all the way down to research services and products. ]]> <![CDATA[Cancer Genetics acquires BioServe India]]> https://biospectrumindia.com/news/95/7428/cancer-genetics-acquires-bioserve-india.html https://biospectrumindia.com/news/95/7428/cancer-genetics-acquires-bioserve-india.html Fri, 16 May 2014 11:16:00 +0530 BioServe India, founded in 2002, is a genomics services provider and molecular kit manufacturer, serving both research and clinical markets. The transaction is expected to close during the third-quarter of 2014, and is subject to customary closing conditions and government approvals in India. Under the terms of the agreement, BioServe Biotechnologies, headquartered in Hyderabad, will become a subsidiary of CGI, and will be renamed as Cancer Genetics Inc. "With Bioserve, CGI will become better positioned to increase our global presence in personalized cancer care and further improve outcomes and lower costs for cancer patients," said Mr Panna Sharma, CEO, Cancer Genetics Inc. CGI plans on retaining all 33 current employees of BioServe India, and further expanding and strengthening the sales and clinical teams in India. BioServe India currently operates out of a state-of-the-art 14,000-square-foot genomics facility in Hyderabad. The company is backed by Ventureast, a pioneering venture capital institution based in India, which has enabled over 80 seed, early and growth stage businesses in a broad array of sectors including technology, life sciences and clean environment. "We are happy to see that a biotechnology company we nurtured from its early stages is graduating to the next level. We share the belief that genomic services, next-generation sequencing and personalized diagnostics have tremendous potential in the country and can grow multi-fold in the coming years," said Mr Venkatadri Bobba, general partner, Ventureast. By utilizing BioServe India's molecular services, researchers can identify genetic markers, validate drug targets and correlate clinical and molecular data to accelerate the development of new and effective drugs. Further added Mr Sharma, "The BioServe India team adds immediate positive impact, high-quality revenue, and provides a clear path to an accretive deal for shareholders. The infrastructure and enhanced capacities in next generation sequencing for oncology accelerate our development plans while positioning us to make more effective use of our capital." Additionally, BioServe India's growing clinical diagnostics capabilities in oncology and next-generation sequencing are well-positioned to serve the needs of improving oncology diagnostics care and management throughout India. Global cancer costs are expected to reach $458 billion in 2030 according to the American Cancer Society. By allowing the Company to scale up operations for genetic analysis, bioinformatics, and manufacturing, this acquisition will provide opportunities to create greater cost efficiencies and increase productivity while bringing clinically validated and actionable genomic content into community hospitals and cancer care centers in India and the US. "It's a proud moment for us at BioServe as we join forces with one of the leading cancer diagnostics providers. There are great synergies which we expect to unlock by combining our visions and teams together," said Mr Rama Modali, founder, BioServe India. ]]> <![CDATA[Sun Pharma settles litigation for drug]]> https://biospectrumindia.com/news/95/3784/sun-pharma-settles-litigation-for-drug.html https://biospectrumindia.com/news/95/3784/sun-pharma-settles-litigation-for-drug.html Thu, 15 May 2014 17:39:08 +0530 Sun Pharmaceutical Industries Ltd. announced that one of its subsidiaries has executed a settlement agreement with Novartis Pharmaceuticals Corporation stipulating a dismissal of the lawsuits filed in the United States against the Company regarding submission of an Abbreviated New Drug Application (ANDA) for a generic version of Gleevec, Imatinib Mesylate tablets. These tablets are indicated for the treatment of chronic myeloid leukemia. Under the terms of the settlement agreement, Sun Pharma's subsidiary may launch its version of generic Gleevec in the United States on February 1, 2016. The other terms of the agreement are confidential. The agreement is subject to customary regulatory approvals. Sun Pharma's subsidiary holds a tentative approval from the US FDA for its ANDA for a generic version of Gleevec. ]]> <![CDATA[Novel AMPK activators: Connexios and Boehringer ink pact ]]> https://biospectrumindia.com/news/95/3173/novel-ampk-activators-connexios-and-boehringer-ink-pact-.html https://biospectrumindia.com/news/95/3173/novel-ampk-activators-connexios-and-boehringer-ink-pact-.html Thu, 15 May 2014 12:05:13 +0530 Bangalore-based biotech company Connexios Life Sciences, and Boehringer Ingelheim announced an exclusive global research collaboration agreement for AMPK for the treatment of patients with type-2 diabetes. The terms and financial details of the collaboration were undisclosed. As part of the agreement, Boehringer Ingelheim obtains global rights to CNX-012, Connexios Life Sciences' program on AMPK activators. The program includes CNX-570 and other compounds which are in early pre-clinical development. Boehringer Ingelheim will be responsible for all further development and commercialization of the candidates from the AMPK program. "As a pure research-driven organization from India, we believe that the agreement with Boehringer Ingelheim is a big validation of both our scientific approach and capabilities as well as of our business model," commented Mr Suri Venkatachalam, CEO and founder, Connexios. CNX-012 is Connexioss' flagship program which leverages Network Biology approach and platform. Commenting on the agreement, Mr Michel Pairet, Senior VP and R&D global head, Boehringer Ingelheim said, "We are extremely pleased to enter into this agreement with Connexios, a company recognized as experts in their field, which will further strengthen our discovery and development efforts in the area of cardiometabolic diseases." ]]> <![CDATA[Bayer HealthCare extends access to clinical trial data]]> https://biospectrumindia.com/news/95/3596/bayer-healthcare-extends-access-to-clinical-trial-data.html https://biospectrumindia.com/news/95/3596/bayer-healthcare-extends-access-to-clinical-trial-data.html Wed, 14 May 2014 18:13:40 +0530 Bayer HealthCare will start sharing data from its clinical studies through the internet portal http://www.clinicalstudydatarequest.com. From now on, qualified researchers can request anonymized patient-level data from Bayer HealthCare sponsored clinical studies listed on the website. By joining the portal, Bayer HealthCare is supporting efforts of the European Medicines Agency (EMA) to increase the transparency of data from clinical studies. As a member company of the pharmaceutical trade associations EFPIA and PhRMA, Bayer is following their declared principles on responsible clinical trial data sharing. "Our commitment to clinical trial transparency reflects our will to foster scientific research and hence public health," said Dr Joerg Moeller, member of the Bayer HealthCare Executive Committee and Head of Global Development. Furthermore he added "Joining the electronic platform and providing access to anonymized patient-level data, protocols and clinical study reports is a further step towards increased transparency while maintaining patient privacy." Secured data access will be granted after approval of the research proposal by an independent scientific review panel. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 1, 2014. Bayer HealthCare is not involved in the decisions made by the independent scientific review panel. Bayer HealthCare will take all necessary measures to ensure that patient privacy is safeguarded, in accordance with applicable laws and regulations. In addition to the data provided via http://www.clinicalstudydatarequest.com, Bayer HealthCare provides through its 'Bayer Trial Finder' available at http://www.bayerpharma.com information about Bayer HealthCare sponsored trials dating back to 2005. This public information first becomes available at the beginning of a clinical study and is updated throughout the conduct of the study. Generally, summaries of trials will be published within a year of study completion. ]]> <![CDATA[KBI Biopharma acquires biologics operations in Colorado]]> https://biospectrumindia.com/news/95/3598/kbi-biopharma-acquires-biologics-operations-in-colorado.html https://biospectrumindia.com/news/95/3598/kbi-biopharma-acquires-biologics-operations-in-colorado.html Wed, 14 May 2014 18:13:00 +0530 KBI Biopharma has signed an agreement with Merck & Co to acquire Merck's microbial process development and manufacturing operations in Boulder, Colorado, effective May 1, 2014. Under the agreement, KBI will provide ongoing development and manufacturing services to Merck, as well as to third party customers. "We are very pleased to continue to advance our partnership with Merck, and to welcome this very highly regarded team of scientists in Boulder to the KBI team," stated Joe McMahon, KBI's president and ceo. "KBI will now offer expanded microbial development and manufacturing services up to 1500L scale, as well as continuing to offer our current full range of process development, analytical and formulation development and mammalian manufacturing services up to 2000L." KBI will also continue to support other ongoing drug development programs for Merck from its two North Carolina facilities. To date, KBI has helped to advance more than 220 molecules in 55 unique health indications for over 170 clients around the world. With the addition of these expanded microbial capabilities, KBI is well positioned to continue to accelerate an even broader range of drug development programs for its global client base. ]]> <![CDATA['Major shift towards green energy by 2020']]> https://biospectrumindia.com/news/95/8038/major-shift-towards-green-energy-by-2020.html https://biospectrumindia.com/news/95/8038/major-shift-towards-green-energy-by-2020.html Wed, 14 May 2014 18:10:00 +0530 The annual event has been jointly organized by Federation of Karnataka Chambers of Commerce and Industry (FKCCI) and MM Activ Sci-Tech Communications. The summit is supported by the Government of Karnataka, creating a platform to showcase the immense business and transformational opportunities in renewable energy. The three-day summit is expected to kick-start on June 5, 2014, and will be culminating on June 7, 2014, at White Orchid Convention Centre and Manpho convention Centre, Bangalore, India. The GREEN Summit will bring in all the leaders from the government, industry, academia, and entrepreneurs, non-governmental organizations and other stakeholders who will influence, define and shape the future of energy in India. The occasion was graced by chief guest, Sri D K Shivakumar, Hon'ble Minister for Energy, Government of Karnataka. The keynote was delivered by Sri P Ravikumar, IAS, Additional Chief Secretary to Government, Energy Department, Government of Karnataka. In his commendable speech, Sri D K Shivakumar elucidated, "A new government is coming up at national level in the country, and the whole world is looking at us. As far as Karnataka is concerned, the state is seen as a global destination. Our country has the necessary human resource with varied capacities." According to the Minister, today Karnataka is self-sufficient in its power generation without any major hiccups. "Today, compared to the demand, we are able to manage our power needs very well. We are looking at having more power generation, adding to the current capacity, ensuring that Karnataka will be 'the' destination for investors. About 22% of the power generated in the state is used by the industries, and 13% for commercial purposes. The government this year has allotted Rs 10,500 crore for subsidies, in that more than Rs 6000 crore will be given to the agricultural sector. About 37-40% of the power produced will also be given for agri purposes," he expressed. The Minister also revealed that, shortly, the new Solar Policy will be in place, which will be liberal and attractive for investors. "We are looking for new thinkers and new investors. We want to distribute solar power to the entire state of Karnataka, and ensure that solar plants are distributed all over the state. At least by 2020, we have to have a major shift towards green energy." Sri Shivakumar fully assured that the government will fully be involved and will want to see Karnataka as a destination for investors across sectors. "I can assure that investors will be provided safe, sufficient and efficient power. The government of Karnataka will stand by in all their endeavours making the state rich, proud, self-sufficient and vibrant," he concluded. Sri P Ravikumar, in his speech, added, "This summit is an opportune moment. We need to come up with new renewable energy policies. This summit will help recognize in formulating new policies which will give an understanding of the renewable energy sector." "There are hiccups like legal, regulatory and local woes that needs to be overcome, otherwise, we'll continue to only talk and see nothing in fruition in reality. We hope that the new Solar Policy will move us in a direction of liberalizing policies. Here, technology is the driver. Fossil fuel-based energy's price is increasing rapidly. Initially the renewables were expensive. But now they have become much cheaper," he added further. Sri Ravikumar also commented on the country's energy security issues. "Our thermal power generation depends on gas and coal. We now import large amounts of coal. Interest rate fluctuation is making fossil fuel imports highly expensive, which ultimately affects our energy security," he said. Talking about energy access, he commented, "Energy access is a driver for renewable energies. Renewable energy is best suited for energy access in remote areas. We are also a part of National Action Plan for Climate Change. It is necessary to reduce the consumption of fossil fuel energy and increase the usage of renewables." "All these factors will combine together to see better renewable energy production and increase in the push by the government. However, the main problem in the industry is in the area of finances. We are trying to bring in financial institutions here and decide the tariff structures so that financial institutions will be enthused to support us more. Thus, we'd like to bring in the industry, government, financers, stakeholders, and players, to make Karnataka a forefront state in renewable energies," concluded Sri Ravikumar. Also, speaking on the occasion was Mr Jagdish Patankar, MD, MM Activ, who opined, "We want to create valuable knowledge and a business forum in this summit. If India has to march forward, it has to work on its infrastructure and energy. The government of Karnataka is playing a great role in supporting various programs related to renewable energy." The key highlights of the conference includes CEO conclave, secretaries conclave, grand challenge, poster session and awards ceremony. Also, the discussions will touch upon technologies, business models, policy, energy security, and renewable energy adoption. The international exhibition will focus on solar energy, energy efficiency, wind power, mini hydel, geothermal, fuel cell, bioenergy, tidal energy, waste to energy and flywheel energy. ]]> <![CDATA['Understanding varied business cultures a challenge']]> https://biospectrumindia.com/interviews/95/7000/understanding-varied-business-cultures-a-challenge.html https://biospectrumindia.com/interviews/95/7000/understanding-varied-business-cultures-a-challenge.html Wed, 14 May 2014 16:36:00 +0530 Dr Zandberg shares his thoughts and views on the current Indo-Israel relationship in the area of life sciences, and he also provides a brief outline on the business opportunities that Indian biotech and pharma companies can leverage in Israel. Excerpts: Q: Can you give us a brief overview on the current existing Indo-Israel relationship? Mr Yair Zandberg: Bilateral trade and economic relations have progressed rapidly since the establishment of diplomatic relations between India and Israel in 1992. From a base of USD 200 million in 1992 (comprising primarily of diamonds and merchandise trade), it has diversified and had increased sharply reaching USD 5.153 billion in 2011. India is Israel's 8th largest trade partner, and Israel's third largest trade partner in Asia, after China and Hong Kong (trade data includes diamonds). In 2011, India was ranked 11th largest import source of Israel including diamonds, and 16th largest import source excluding diamonds. Q: What opportunities does Israel offer to Indian biotech and life sciences companies? There are multiple ways Israel and India could benefit in the biomedical sector. Opportunities shall grow from the strengths of each country. Below is the list of several of them: â€¢ As India is blessed in CROs and very high number of doctors,one option will be doing joint R&D projects with respect to clinicaltrials in India, like Cipla, Intas & cadila. â€¢ APIs - Israel today buys a lot of APIs from India. In this regard, India could do specific APIs for Israeli needs, achieving fast needed results. â€¢ In addition, India can be used as a gate for the Israeli market to South-East Asian markets by utilization of existing trade relations of Indian companies or indirect marketing, to inaccessible markets for Israeli companies. â€¢ Israeli strengths can bring value for Indian companies. Israel is known for its excellence in pharma drugs for central nerve system & cancer, and also for innovative medical devices. Indian bioscience companies can benefit from JVs in those areas or also bymarketing those quality products in India. â€¢ Same as India, Israel can be used as a gate for the western markets, as Israeli companies have very good trade agreements with the EU and US, while Israeli products enjoy very good reputation in those markets. Q: What advice or precautionary measures would you offer to Indian companies who are seeking to establish a base or collaboration in Israel? As any entry to a new market, FIICC advises the following:a. Ensure proper business planningb. Take close care of locating the right partner for your businessc. Work closely with the Indian embassy in Tel-Aviv which is highly effective in assisting Indian companies doing business in Israel Q: Would you like to give us Israel's USP for Indian biotech companies who would want to invest in Israel? From FIICC point of view, "Taro" was a great opportunity. However, similar opportunities do not emerge frequently in the Israeli market. However when Israeli opportunities are emerging, our best advice will be to maintain the Israeli spirit and team (and vice versa), and in that way both sides will benefit. A good example will be Sun's decision to take Mr Israel Makov, ex-Teva CEO, to become Sun's chairman. Q: How can Indian institutions and universities leverage on what Israel has to offer in the life sciences area? In all the Israeli universities there are commercialization arms that know very well to collaborate with other companies and universities. Very important to do the right check with the Israeli OCS, as well as look for MATIMOP relationship. Q: What would be the initial challenges for Indian companies who want to establish themselves in Israel? From FIICC point of view, the initial challenge will be the gap between the two different business cultures. A good way to deal this is using a lot of patience, understanding the gaps and learning how to bridge them. Q: What message do you have for Indian entrepreneurs who are apprehensive about investing in Israel in the midst of instability looming over the global economy? The Israeli economy is one of the most stable economies over the past decades. As the FIICC was chosen by the Embassy of India in Israel to lead Karnataka's delegates as part of the Indian delegation to the first Israel innovation conference, happening between May 17 - 23, 2014. We recommend that each of the Indian entrepreneurs to join us and explore the opportunities that the Israeli market has to offer. Q: In terms of finances, how would you help Indian companies? The main Indo-Israel new initiative that FIICC see fit to note is 'Karnataka and Israel Program for Industrial R&D' (KIRD), recalling the Umbrella Agreement on the Development of Cooperation in the Field of Industrial and Technological Research and Development between the State of Israel and the Republic of India, signed in New Delhi, on December 30, 1996. The Government of Karnataka executed an MoU with Israel to carry out joint industrial R&D projects between Karnataka-based companies and Israel. This MoU was signed in March 2013 between MATIMOP - the Israeli Industry center for R&D, on behalf of the Office of the Chief Scientist (OCS) in Israel; and the Karnataka Science and Technology Promotion Society (KSTPS) and the Karnataka State Council for Science and Technology (KSCST), autonomous organizations under the Departmentof Science and Technology, Government of Karnataka, in India. Under this MOU program, Karnataka and Israel Program for Industrial R&D (KIRD) has been initiated to create mechanisms through which small/medium scale industries located in Karnataka, could be funded for engaging in joint bilateral research and development (R&D)projects, with Israel. KIRD Program is taking-off this days. Ten companies, mostly from the Defence Industry, were approved by MATIMOP and KSCST, the implementation agencies, and began the process for getting the coveted fund at the beginning of 2015. FIICC is extremely happy to update that a similar program is on the brink of signing with Gujarat and the Israeli government's intention is to expand the program to other states of India. Q: Post establishment, what kind of support would you extend further to companies? Assisted by Mr Vibin Joseph, executive director, Biozeen, as an FIICC Advisor for the biotech sector, our focused support for those companies will be preserving the growth of those companies by providing real-time information about new business opportunities and proactive introductions for new optional partners. We will also provide updates about bilateral agreement and government's new initiatives and also promote bridging the cultural gaps by our environmental seminars. ]]> <![CDATA[Dr Reddy's appoints new chairman]]> https://biospectrumindia.com/news/95/3159/dr-reddys-appoints-new-chairman.html https://biospectrumindia.com/news/95/3159/dr-reddys-appoints-new-chairman.html Wed, 14 May 2014 14:05:00 +0530 Bangalore: With an intent to reorganize roles and separation of activities, Dr Reddy's has appointed K Satish Reddy as the chairman of the board in place of Mr G V Prasad. Dr Satish Reddy was the vice chairman and chief operating officer (COO) of the Reddy's. Following changes, Mr G V Prasad has been appointed as the co-chairman and managing director while Mr Abhijit Mukherjee who was the president of Global Generics Business is announced as the COO. "Dr Satish Reddy can significantly contribute to achieving a direction for various CSR as well as industry associations at the same time safeguard the brand name while governing the board." quoted Mr G V Prasad. Dr Satish Reddy commented on his appointment saying that it was an honour to be the Chairman and that he and Mr Prasad have worked diligently to envision the dream of turning Dr Reddy's to a leading pharmaceutical company. The new roles should help in giving focus to distinct activities as well as internal growth of management. ]]> <![CDATA[FDA to India: Regulatory compliance a must]]> https://biospectrumindia.com/news/95/7400/fda-to-india-regulatory-compliance-a-must.html https://biospectrumindia.com/news/95/7400/fda-to-india-regulatory-compliance-a-must.html Wed, 14 May 2014 12:24:00 +0530 Bangalore: "Make quality the top priority," was the clear message from the FDA officials to Indian Pharma companies. A two day meeting, conducted by the Central Drug Standards Organisation (CDSCO) and Indian Pharmacetical alliance (IPA), was held in Hyderabad on May 5, followed by workshops in Goa, Ahmedabad, and Chandigarh for the Indian drug industry and the regulators from CDSCO. The meeting and workshops that marked the beginning of a one-on-one discussion with the FDA, saw huge participation from the industry. Ms Leslie Ball, assistant commissioner and deputy director, Office of International Program at the FDA said that the workshop was an excellent opportunity to for the FDA to put forth their expectations and receive feedbacks. She further said that the companies must have quality culture and should be doing what they say, saying what they do and seek improvement. Since the beginning of last year, there's been a spike in "violations" at India-based drug plants, according to data from FDA's Centre for Drug Evaluation and Research. In its latest word on Indian drug makers, the US top drug regulatory agency, the Food and Drug Administration (FDA) has said that the industry needs to continuously upgrade and strengthen their facilities to uphold quality and safety of pharmaceutical products. Mr Howard Sklamberg, deputy commissioner, USFDA, Global Regulatory Operations and Policy, emphasized on the role of senior management in ensuring a quality culture within a company. He highlighted that the six elements inspected by the FDA were materials, equipment and facilities, production, laboratory, packaging and labeling. Dr Satish Reddy, chairman of the Dr Reddy's Laboratories and the president of the Indian Pharmaceutical Alliance commended the workshops as the efforts in the right direction to enhance quality standards. ]]> <![CDATA[Pharma exports to US unperturbed by import alerts: Ind-Ra]]> https://biospectrumindia.com/news/95/7789/pharma-exports-to-us-unperturbed-by-import-alerts-ind-ra.html https://biospectrumindia.com/news/95/7789/pharma-exports-to-us-unperturbed-by-import-alerts-ind-ra.html Tue, 13 May 2014 13:14:00 +0530 India Ratings & Research (Ind-Ra) expects Indian pharmaceutical exports to the US to keep growing despite a spate of import alerts issued by US Food and Drug Administration (US FDA) in 2013. Ind-Ra believes the potential for the Indian pharmaceutical industry to grow at around 20 percent CAGR over the next five years is intact. This is despite the agency's expectation of an increase in US FDA inspections in line with the US' increasing dependence on Indian pharmaceuticals and the bad press attracted by them in recent times. Export growth to the US is also likely to be robust, given the large proportion of alternative new drug application approvals received by Indian manufacturers lately. Indian pharmaceutical manufacturing facilities registered with US FDA as on 31 March 2014 was 523, the highest for any country outside the US. The agency also believes that the Indian pharmaceutical industry will establish quality assurance processes as well as a compliance culture to reduce import alerts. The US has become the single-largest destination for Indian pharmaceutical exports, a position Ind-Ra expects to continue in wake of the government's resolve to provide affordable healthcare. Ind-Ra estimates that banned facilities accounted for around 7 percent-8 percent of the total exports to the US and around 2 percent of the overall 2013 pharmaceutical exports from India. However, the owners of the banned facilities will face not only a revenue loss but also a substantial opportunity loss on account of delayed product introductions and expenditure on corrective actions. ]]> <![CDATA[HCL for global infrastructure management: Novartis's choice]]> https://biospectrumindia.com/news/95/4976/hcl-for-global-infrastructure-management-novartiss-choice.html https://biospectrumindia.com/news/95/4976/hcl-for-global-infrastructure-management-novartiss-choice.html Tue, 13 May 2014 13:13:00 +0530 HCL Technologies, a leading IT services provider, announced that it has been selected by Novartis, one of the world's leading healthcare companies, to provide global infrastructure management services. Novartis will leverage HCL's global delivery model for remote infrastructure management services across its entire data centre landscape, covering more than 70 countries across six continents. "This partnership creates an environment of continuous service improvement, transformation and innovation" said Mr Ashish Gupta, executive vice president and head of Infrastructure Services, EMEA, HCL Technologies. "This is a great recognition of HCL's capabilities in remote infrastructure management. Our outcome-based business models, best practices and tools deliver proven value and cost savings that help our clients to be more competitive and responsive to changing market dynamics. Our commitment to building a relationship beyond the contract will ensure our collaborative engagement with Novartis will benefit both parties for years to come." The deal marks an important infrastructure outsourcing contract in HCL's DACH region, and strengthens the company's global expertise in infrastructure management within the pharmaceutical sector. HCL is now managing the infrastructure environment of four of the top seven pharmaceutical companies worldwide. ]]> <![CDATA[Cipla invests in Chase Pharmaceuticals]]> https://biospectrumindia.com/news/95/6062/cipla-invests-in-chase-pharmaceuticals.html https://biospectrumindia.com/news/95/6062/cipla-invests-in-chase-pharmaceuticals.html Mon, 12 May 2014 17:04:00 +0530 Cipla Limited, a global healthcare company which uses cutting edge technology and innovation to meet the everyday needs of all patients, today announced its investment in Chase Pharmaceuticals Corporation, US ("Chase"), through its wholly owned subsidiary, Cipla (EU) Limited, UK. Chase is an early stage drug development company, based in Washington DC. Chase is focused on developing novel approaches to improve treatments for Alzheimer's disease. It has a unique patented approach and is focused on improving the efficacy, safety and tolerability of existing Alzheimer medications. Cipla, through its impact investment unit, Cipla New Ventures is investing in the Series B round of financing as part of a syndicate, which also consists of Edmond de Rothschild Investment Partners and New Rhein Healthcare LLC. Cipla New Ventures was set up to chart a trajectory in innovation around biologicals, repurposing existing safe drugs and leveraging Cipla's enviable suite of delivery technologies through disruptive innovation around access and affordability. It is managed by Mr Chandru Chawla. Commenting on the investment, Mr Subhanu Saxena, managing director and global ceo, Cipla said "This investment is consistent with Cipla New Ventures' mission to build more innovation-led business streams for Cipla in the future. We want to bring affordable medicines, where we identify an unmet patient need, in a way that leverages Cipla's formidable technology, device and development capabilities." In India, over 5 million patients suffer from dementia, most of whom are afflicted with Alzheimer's. These numbers are expected to double by 2030. In India, the caregiver is the family and the economic and social impact is far reaching. In North America, Alzheimer's disease affects more than 7 million patients and its impact is growing as the population ages. The disease costs the US alone $203 billion annually with projections to reach $1.2 trillion by 2050. In addition to financing Chase, Cipla will collaborate with the company to develop the drug. If successful, Cipla may provide low cost access to Chase's lead drug in India and South Africa where Cipla has championed affordable access to essential and life-saving medications for decades. ]]> <![CDATA['Understanding cultures impact research outcomes']]> https://biospectrumindia.com/features/95/7390/understanding-cultures-impact-research-outcomes.html https://biospectrumindia.com/features/95/7390/understanding-cultures-impact-research-outcomes.html Mon, 12 May 2014 16:56:00 +0530 Focusing on developing strong tie-ups in the area of unmet medical needs, the team aims to promote strategic investment to bridge the existing gap between academic research discovery and commercial exploitation and development. Excerpts: Dr Andrew Milner, MD & CEO, Neurosciences Victoria: Global diseases of the brain and mind are really important issues of unmet medical needs. In children, we are focusing on cerebral palsy, which is veryprevalent in India than Australia. When people from India go to Melbourne, there is much more opportunity for collaboration because a strong relationship is developed. It takes time to develop research groups to get comfortable with each other. It is a wonderful opportunity for Asians to access new drugs and bring it to their marketplace. Dr Atul Malhotra, Neonatal Pediatrician, Monash Newborn, Senior Lecturer, Monash University: The common reason for death of babies in India is infection and birth asphyxia. Statistics show that 40-50% of death happens due to this condition that we try to address here. High cost of the Australian Dollar and high standard of living puts pressure on individuals to travel or invest in Australia. The landscape is constantly changing because of various issues. Though investments are difficult, opportunities are available in plenty. In the neonatal care, we have a big influx of Indian graduates and post graduates who want to enrich their training experience, and more opportunities can be made available to them. Prof Jayashri Kulkarni, Director, Monash Alfred Psychiatry research center (MAPrc): The global unmet medical needs in terms of mental diseases like depression and psychotic illnesses are very common. It is estimated that 30% of the Indian population experience depression at some point and women are more susceptible. The main unaddressed issue here in India is women's mental health. The initial challenges would be the diseases themselves. We are dealing with big diseases. Being in one world, we need to have collaborations by combining scientific knowledge and experience, particularly in the area of mental illnesses. In Australia, we have different processes for IPs, investors, clinical trials and technologies. Australia has a smaller population to conduct clinical trials and that is a disadvantage. In India, the issues are different, which could range from funding sources and ethical issues to investments. The richness in understanding each other's culture has a great impact on the outcomes. Mr Nathan Farrow, Program Manager, Australia-India Trauma Systems Collaboration, National Trauma Research Institute, The Alfred Hospital & Monash University: In India, we want to develop organized trauma systems. Australia has a lot to learn from India about managing large volumes of trauma. We are excited to be here. Australia and India has different strengths which complement each other. In India, 5.8 million people die every year from traumatic injuries, and 90% of them happen in developing countries. Dr Henry De Aizpurua, Deputy Director, The Florey Institute of Neuroscience and Mental Health: There are opportunities at three levels. Firstly, we take smart and well-trained Indian researchers andput them in Melbourne, exposing them to new ideas and perspectives that is not available here. Secondly, when they return, they bring these perspectives and skills to India thereby benefiting their own country. Thirdly, we want to partner in co-development of new measures that we are working on and bring them forward at a faster rate. In drug development, at the discovery and early preclinical discovery stage, Melbourne has everything from medical chemistry, toxicology, animal models of human diseases, to magnetic resonance imaging pit. Wehave the ability to partner with like-minded scientists to establish real partnerships. Prof Graham Jenkin, Deputy Director, The Ritchie Centre for Translational Research, Monash Institute of Medical Research: It is essentially the interchange of scientists between India and Melbourne. People from both the sides visit and learn from each other and gain wonderful experience. Stem cell research and its clinical translation in India is considerably expanding internationally. That's an area of mutual research interest for us. ]]> <![CDATA[WHO calls for greater investment in battling malaria]]> https://biospectrumindia.com/news/95/3506/who-calls-for-greater-investment-in-battling-malaria.html https://biospectrumindia.com/news/95/3506/who-calls-for-greater-investment-in-battling-malaria.html Fri, 09 May 2014 12:43:00 +0530 Even though the number of confirmed malaria cases in the region decreased from 2.9 million in 2000 to 2 million in 2012, the disease remains a significant threat to the lives and livelihoods of people. Recently on World Malaria Day, WHO urged governments, development partners and the corporate sector to invest more to sustain these gains and eliminate malaria. "1.4 billion People continue to be at risk of malaria in South-East Asia. They are often the poorest, including workers in hilly or forested areas, in development projects such as mining, agro-forestry, road and dam constructions, and upland subsistence farming in rural areas and urban areas," said Dr Poonam Khetrapal Singh, WHO Regional Director for South-East Asia. Bangladesh, Bhutan, Democratic People's Republic of Korea, Nepal, and Sri Lanka reduced the incidence of malaria cases by more than 75 percent from 2000 to 2012. Thailand and Timor-Leste are on track to achieve a decrease of over 75 percent. India is expected to decrease malaria case incidence by 50-75 percent by 2015. Sri Lanka is in the elimination phase; the country has had no indigenous cases since November 2012, down from 203 000 cases in 2000. Maldives has been malaria-free since 1984. Global efforts to control and eliminate malaria have saved an estimated 3.3 million lives. Between 2000 and 2012, malaria mortality rates have been reduced by 42 percent and the incidence of malaria has decreased by 25 percent globally. But the gains in malaria control, although substantial, could be reversed due to increasing parasite resistance to drugs, mosquito resistance to insecticides and re-introduction of transmission in places where the disease has been eliminated. Dr Poonam further stated, "We must continue surveillance for malaria. Funding needs to be increased for diagnostics, drugs, insecticide-treated mosquito nets, and research and response to drug and insecticide resistance. We need to empower communities to protect themselves. Eliminating malaria will take greater political will." The emergence of Artemisinin resistance in Cambodia, Myanmar, Thailand and Vietnam threatens the global achievements in malaria control and elimination. Artemisinin-based combination treatment (ACT) is currently the first line treatment for the most lethal type of malaria, Plasmodium falciparum. Resistance to this drug would compromise the lives of hundreds of thousands of people affected with malaria, and there is an urgent need to invest in ways to contain the spread of resistance to these drugs. Another danger lies in the fact that the Anopheles mosquitoes, which carry malaria parasites, are increasingly become resistant to insecticides. There is a need to contain the emergence and spread of resistance of Anopheles mosquitoes to insecticides. Moreover, re-introduction of transmission in areas free of malaria is always a threat if surveillance and rapid response are not sustained. Investments are needed to develop new tools, to conduct operational research to address bottlenecks in malaria control programmes, and to scale-up and ensure rational use of existing interventions. There is also a need to further strengthen health systems and mobilize multisectoral actions to accelerate progress towards elimination of malaria as a public health problem. ]]> <![CDATA[UN backed panel delibrates on universal health coverage in India]]> https://biospectrumindia.com/news/95/6311/un-backed-panel-delibrates-on-universal-health-coverage-in-india.html https://biospectrumindia.com/news/95/6311/un-backed-panel-delibrates-on-universal-health-coverage-in-india.html Fri, 09 May 2014 09:14:00 +0530 "The disease burden, infrastructural and personnel requirements and health financing situation are the three elements that need to be analyzed to plan the design of the UHC model(s) to be rolled out in India," remarked Professor Indrani Gupta, Institute of Economic Growth at a panel discussion supported by the United Nations in India deliberated on India's route to Universal Health Coverage. "The ministry of health and family welfare has already suggested a list of indicators for an essential health package which need to be taken into consideration. The roll out process has to be accompanied by a solid management information system and monitoring and evaluation framework from the start, to help in course correction based on evaluations," Prof Gupta added. In her remarks, Lise Grande, United Nations Resident Coordinator said, "Universal Health Coverage is a high priority in India. We are particularly worried about families who fall below the poverty line when someone falls ill and the family has to struggle to pay for health care." Speaking on the occasion, Dr Nata Menabde, WHO Representative to India highlighted the importance of substantially increasing the government expenditure on health in India which is one of the lowest in the world, at around one percent of GDP. She commended the policy intent outlined by the Planning Commission to increase government spending on health to 1.87 percent of GDP by 2017. About 100 participants consisting of officials, professionals, students from health and development related institutions, the media and the United Nations attended the panel discussion. Outlining that no country in the world has fully 'achieved' UHC in a short period as there is always some gap between the need and utilization, and there is also scope for improvement of quality and financial protection, Dr. Menabde said, "Universal Health Coverage should be conceptualized as a direction rather than a destination, an idea that is relevant for India." The discussion with WHO experts from different regions of the Organization was moderated by Dr Antonio Duran, Advisor, WHO Country Office for India. The experts shared examples from various countries on the UHC experiences, what works and what doesn't. It was also brought out that India's progress towards UHC does not merely require a higher level of public financing for providing and purchasing health care in an integrated manner but also sustained efforts to hasten the development of a well governed health system allowing better access to quality medicines, vaccines and new and appropriate technologies as also strengthening of human resources for health. ]]> <![CDATA[ CSIR and DST to remain headless for now?]]> https://biospectrumindia.com/news/95/6586/-csir-and-dst-to-remain-headless-for-now.html https://biospectrumindia.com/news/95/6586/-csir-and-dst-to-remain-headless-for-now.html Wed, 07 May 2014 14:45:00 +0530 The retirement of Dr T Ramasami on May 05, 2014, has left the department of science and technology (DST) without a leader at the moment. Keeping that in view, the secretary of department of biotechnolgy (DBT), Dr K Vijay Raghavan has been given additional responsibility of DST by the government. The appointment of new secretary is likely to happen weeks after May 16, 2014 when the new government takes over at the centre. While it can be understood that the present government avoided making direct appointment at this juncture but what can't be is that it could have been done few months back. Dr Ramasami who is known as an efficent admistrator and advocate of science, would surely have stepped aside to pave the way for it. Since Dr Ramasami was also handling the additional charge of director general, Council for Scientific and Industrial Research (CSIR), this key scientific agency too shall remain headless for the next couple of few weeks. While the ministry of science and technology might make some interim arrangement or perhaps it would exist by default, but the question is whether that is acceptable in a democratic country like India. The reasons behind the delay in appointments has been a key headache for the UPA government, now facing tough times in the current elections. Earlier, as per sources, Dr Suresh Das who is currently serving as the director of National Institute for Inter-disciplinary Science and Technology, Thiruvananthapuram, was recommended to head the CSIR by the expert committee that found his credentials right enough. However, the S&T ministry higher ups (minister ignored the commitee suggestions twice) chose to put that on hold. Politics and science surely don't share an easy relationship. ]]> <![CDATA[Shasun acquires global rights for Ibuprofen extended release OTC & Nuprin brand]]> https://biospectrumindia.com/news/95/4845/shasun-acquires-global-rights-for-ibuprofen-extended-release-otc-nuprin-brand.html https://biospectrumindia.com/news/95/4845/shasun-acquires-global-rights-for-ibuprofen-extended-release-otc-nuprin-brand.html Tue, 06 May 2014 16:28:00 +0530 Shasun India, an integrated pharmaceutical company acquired global rights from ScolrPharma, USA to develop and commercialize Ibuprofen 12 hour Extended Release OTC tablets ("Asset") as well as associated Controlled Release Technology (CDT) and Nuprin trademark, a well-known brand in analgesics, through its wholly owned subsidiary, SVADS Holdings, Switzerland. The Asset, having completed phase III successfully in the US, is a differentiated long acting NSAIDS in the multibillion dollar global OTC analgesic market. Shasun is the world's leading, vertically integrated manufacturer of Ibuprofen and its derivatives, from actives to formulated packaged products for both the Rx and OTC markets. This acquisition complements Shasun's strategy to expand its range of NSAIDS products through novel, safe and efficacious delivery technologies including transdermal applications across its Ibuprofen franchise. Commenting on the acquisition, Mr S Abhaya Kumar, managing director, Shasun Pharmaceuticals Ltd said, "The acquisition is the first among a series of strategic initiatives in our quest to continue to enhance our global leadership in the NSAIDS category. Our commitment to reliable and affordable innovation across Ibuprofen franchise is not only focused on providing safer products which can enhance patient compliance but also provide a differentiated launch pad for Shasun's partnership in the OTC and Rx markets worldwide." ]]> <![CDATA[Polio, an international public health emergency]]> https://biospectrumindia.com/news/95/5781/polio-an-international-public-health-emergency.html https://biospectrumindia.com/news/95/5781/polio-an-international-public-health-emergency.html Tue, 06 May 2014 11:46:00 +0530 In a first, the World Health Organisation has declared polio as an international public health emergency. It has said that polio could grow in the next few months and has described the current polio outbreaks across at least ten countries in Asia, Africa and the Middle East as an "extraordinary event" that required a coordinated international response. WHO pointed out that Pakistan, Syria and Cameroon have allowed the virus to spread beyond their borders, and recommended that those three governments require citizens to obtain a certificate proving they have been vaccinated for polio before traveling abroad. "Until it is eradicated, polio will continue to spread internationally, find and paralyze susceptible kids," Dr Bruce Aylward, who leads WHO's polio efforts said in a press conference. The WHO has never before issued an international alert on polio, a disease that usually strikes children under five and is most often spread through infected water. There is no specific cure, but several vaccines exist. Many experts have said that fear is looming large because polio is re-emerging in countries previously free of the disease, such as Syria, Somalia and Iraq, where civil war or unrest now complicates efforts to contain the virus. Further, they said that this is happening during the traditionally low season for the spread of polio. Experts have also expressed concern about polio cases increasing as the weather becomes warmer and wetter in the coming months across the northern hemisphere. The vast majority of new cases are in Pakistan, where the WHO has set up an independent monitoring board. At the end of last month, there were 68 confirmed polio cases worldwide, compared with just 24 at the same time last year. In 2013, polio reappeared in Syria, sparking fears the civil war there could ignite a wider outbreak as refugees flee to other countries across the region. The virus has also been identified in the sewage system in Israel, the West Bank and Gaza, although no cases have been spotted. In February, the WHO found that polio had also returned to Iraq, where it spread from neighboring Syria. It is also circulating in Afghanistan (where it spread from Pakistan) and Equatorial Guinea (from neighboring Cameroon) as well as Nigeria, Ethiopia, Somalia and Kenya. Officials also worry countries torn by conflict, such as Ukraine, Sudan and the Central African Republic, are rife for polio reinfection. ]]> <![CDATA[ Sun Pharma announced manufacturing consolidation]]> https://biospectrumindia.com/news/95/3288/-sun-pharma-announced-manufacturing-consolidation.html https://biospectrumindia.com/news/95/3288/-sun-pharma-announced-manufacturing-consolidation.html Mon, 05 May 2014 14:32:00 +0530 Sun Pharmaceutical Industries Ltd. announced that, as a part of its manufacturing consolidation in the US, it has notified the Workforce Development Agency for the State of Michigan regarding its decision to cease manufacturing operations and close the Detroit (Caraco Pharmaceutical Laboratories, Ltd.) facility located at Elijah McCoy Detroit, Ml, USA. The Company has provided the requisite advance written notice of the facility closure to the employee union and all affected employees. The Company has ensured that the impacted employees get compensated with more than their regular entitlement under the severance package. They will also receive other support services including out-placement assistance. The rest of the employees are continuing through mutually consented arrangements. The Company has undertaken necessary measures to ensure business continuity of the products being manufactured at this facility. The manufacturing of these products is being transferred to other units and all necessary steps have been taken to avoid market shortage. ]]> <![CDATA[Sun Pharma rises from the ashes of Ranbaxy as global generics powerhouse]]> https://biospectrumindia.com/views/95/3160/sun-pharma-rises-from-the-ashes-of-ranbaxy-as-global-generics-powerhouse.html https://biospectrumindia.com/views/95/3160/sun-pharma-rises-from-the-ashes-of-ranbaxy-as-global-generics-powerhouse.html Mon, 05 May 2014 13:13:55 +0530 For more than four decades the Ranbaxy star shined brightly over India's pharma landscape and also in the global generics markets thanks to the immense help provided to it by the company's Japanese collaborator, Shionogo & Company, the developer of cholesterol-lowering drug, Crestor. But it was left to another Japanese company, Daiichi Sankyo, to bring the controversial chapter of Ranbaxy to an end in April 2013. Yes. That is the clear message from the $4 billion sale of Ranbaxy by Daiichi Sankyo to a new suitor, Sun Pharamceuticals in early April 2013. Daiichi which bought majority stake in Ranbaxy for nearly $7 billion in 2008 has cut its losses by exiting at half the purchase price. Ranbaxy has been in the news for all the wrong reasons in the past few years, such as falsifying clinical trial data to get drug approvals in the US and for poor quality of some of its products. In fact, Ranbaxy had to pay a hefty fine of more than $500 million to settle some of these claims in recent years. What is clear is that Sun Pharma has picked up Ranbaxy for its manufacturing facilities across the globe and access to markets in African and Latin American countries. Sun Pharma, the Indian generics major, will now move to the 5th position globally in terms of generics market size. However, it will have no use for Ranbaxy name after some time and so the brand which of late is synonymous with everything that is wrong with a business model that exploits regulatory loopholes will die a natural death. It did not start this way. Two Sikh brothers formed this company in undivided India in 1937 to distribute medicines from Shionogo. The company was bought over in 1957 by their cousin Bhai Mohan Singh. And the Japanese company helped Ranbaxy set up manufacturing facilities in the 1950s and 1960s and soon Ranbaxy became a stellar example of an Indian enterprise. This is what prompted Daiichi Sankyo to buy into Ranbaxy in 2008 and ride on its global reach. But what it overlooked was apparently the rotten core inside the heart of Ranbaxy's operations. All the good will seems to have been blown under the leadership of the third generation family members who shut their eyes on questionable manufacturing and business practices, leading to the eventual fall from glory for a brand name that was once synonymous with quality medicines. Ranbaxy-Sun Pharma is not the only deal which made waves in April. A $20-billion 3-way swap of oncology, vaccine and animal product brands between GSK, Novartis and Eli Lilly, has also made waves around the world. With these deals, GSK consolidates its position as a global vaccine leader, Novartis enhances its already formidable presence in cancer treatment products and Eli Lilly, surprisingly emerges as the world No 2 in animal health products. Some more rounds of deal makings are expected as Novartis while shedding its vaccine portfolio has retained influenza vaccine products. Expect it to unload it soon at a hefty premium. To top it, the rumor of a $100 billion offer to Pfizer to buy out AstraZeneca is also swirling around. If that happens in the near future, there will one less Big Pharma company ]]> <![CDATA[ICAR to commercialize indigenous technologies]]> https://biospectrumindia.com/news/95/5461/icar-to-commercialize-indigenous-technologies.html https://biospectrumindia.com/news/95/5461/icar-to-commercialize-indigenous-technologies.html Mon, 05 May 2014 11:34:00 +0530 Around 300 new technology models have been developed under NAIP, of which 80 are commercialised so far. Before the project closes in June this year, ICAR said it would sell up to 30 top technologies developed under the project. While interacting with media, Dr S Ayyappan, secretary, DARE and director general, ICAR said that the main idea behind organizing the Conclave is to foster and take the technologies and innovations developed by NAIP for adoption by the entrepreneurs, business enterprises, government and private sector. He also hoped that this conclave will also act as a platform to disseminate more information about the overall achievement of NAIP in transforming the agriculture sector of the country to new heights. Dr D Rama Rao, national director, NAIP informed that during the last seven years, NAIP has accorded high priority to generation and transfer of agricultural technologies and innovative processes. The integrated farming system based livelihood models developed by NAIP are being adopted in number of States by government departments and universities with support from national programs like RKVY, NAREGA, NHM, etc. About 80 technologies are commercialized to agribusiness entrepreneurs and corporate. Dr S K Dutta, deputy director general (Crop Sciences); Dr B Meenakumari deputy director general (Fisheries); National Coordinators of NAIP Components; officials of World Bank; and scientists of ICAR were also present during the press meet. Two other events to be held prior to the Agri-Innovation Conclave are 'Agri Biz Idol Camp' and 'Kisan Parivartan Yatra' with the aim of encouraging more active participation from the public and private sector with ICAR and help in promoting innovation, partnership and entrepreneurial climate in the agricultural sector. The Agri-Biz Idol Camps aim to identify, support and encourage young entrepreneurs with high potential in business start-ups in agriculture. The program focusses on youth in the age bracket of 18-30. These camps will be a unique platform for the students to pitch their business ideas and develop new agri-ventures. Krishi Parivatan Yatra is being organised to cross-leam the ways and means of success in developing agri-business enterprises to generate more such success stories across the country. This Yatra will take the best of 50 enterprises developed from various NAlP projects and share their success stories with other funners or entrepreneurs in each of the five locations where the melas are being conducted. ]]> <![CDATA[Skin diseases to grow in India by 2015: Report]]> https://biospectrumindia.com/news/95/8437/skin-diseases-to-grow-in-india-by-2015-report.html https://biospectrumindia.com/news/95/8437/skin-diseases-to-grow-in-india-by-2015-report.html Fri, 02 May 2014 17:39:00 +0530 The skin care segment has shown tremendous growth and emerged as a potential investment area for players in recent years. From treatment of common skin care diseases, the skin care industry has evolved to the age of cosmetic and anti-aging treatments. The overall skin care market is expected to grow with the rise in demand of various skin care services. Factors like global warming, anti-aging solutions, new product innovations, growing media influence, etc. are driving this market. Boosted by growing consumer demand, rise in disposable incomes, lifestyle related disorders, craze for cosmetic surgeries, obsession for young-looking skin, low cost of treatment, and booming medical tourism, the skin care market in India is likely to expand and emerge as a potential investment area for players. The market for anti-aging solutions has also become vibrant in India with rising concerns about beauty and looks. Nowadays, more young people are visiting doctors and dermatologists to improve and maintain their youth. The craze for cosmetic surgeries has put India among the top five countries in the world to perform surgical procedures like Lipoplasty, Rhinoplasty, and Bhleroplasty, etc. The demand for non-surgical procedures like Botox, Hyaluronic acid treatment, and laser hair removal is also very high. The prevalence of skin disease in India is 10 to 12 percent of the total population with Eczema and Psoriasis being the major contributors. Due to pollution, ultraviolet light, and global warming, photosensitive skin disorders like tanning, pigment darkening, sunburn, skin cancers, and infectious diseases are increasing at a faster pace. A one percent reduction in ozone leads to a two to four percent increase in the incidence of tumors. The growth and future prospects in the skin care market have forced drug companies to tap the opportunity of selling over the counter (OTC) drugs by bringing novel compounds in and by selling the products of international players under a licensing agreement. According to Ankit Goyal, Program Manager, Healthcare Practice, Frost & Sullivan, "The ecosystem for skin care treatment is witnessing a great change in demand patterns. Gone are the days, when skin care was limited to treatment of common skin diseases. The emergence of cosmetic and anti-aging treatments has changed the face of the skin care industry. The number of these cosmetic procedures is expected reach 18 to 20 lakh by 2015 in India. In 2013, with prevalence rate of 10 percent, the population affected across India from skin disease is estimated at nearly 15.1 crore. It is estimated that at a CAGR of 12 percent about 18.8 crore people is likely to suffer from skin disease by 2015". During the past five years, there has been a considerable growth in the Indian cosmetic/aesthetic surgery industry. The demand is high in urban regions like Chandigarh, Mumbai, Delhi, Chennai, Kolkata, Hyderabad, Bangalore, and Pune. Goyal further opines, "Skin disorders are among the most common diseases in school children in both developing and industrialized countries." He adds, "The severity of growing skin diseases in India is further emphasized by the fact that the World Health Organization (WHO) has included skin disease under the most common non-communicable diseases in India. In addition, there is a lack of facilities that provide comprehensive skin related treatments under one roof." The situation is further worsened by the low availability of dermatologists in India. At present, there are about 6,000 dermatologists catering to a population of over 121 crore. This means that for every 100,000 people, only 0.49 dermatologists are available in India as compared to 3.2 in many states of the US." Various tertiary care private setups lack the capability to treat chronic, genetic and pediatric skin ailments. In addition, their ability to provide comprehensive derma pathology and immunopathology units is also limited. Non-surgical cosmetic services provided by standalone skin care centers cater to only a small segment of skin treatment and a particular segment of the society. Hence, there is a dire need of comprehensive skin care setups providing all skin care treatments under one roof. ]]> <![CDATA[India and Canada to engage in key research partnerships ]]> https://biospectrumindia.com/news/95/3790/india-and-canada-to-engage-in-key-research-partnerships-.html https://biospectrumindia.com/news/95/3790/india-and-canada-to-engage-in-key-research-partnerships-.html Thu, 01 May 2014 17:36:00 +0530 The Department of Biotechnology (DBT) and IC-IMPACTS Centres of Excellence, Canada, are the implementing organizations from the Indian and Canadian sides respectively. IC-IMPACTS Centres of Excellence is a not-for-profit organization established by the Federal Government of Canada through the Networks of Centres of Excellence Program to serve as a pan-Canadian agency responsible for the delivery of research programs in the areas of safe and sustainable infrastructure, integrated water management, and public health: disease prevention and treatment between Canada and India. The deadline for project proposal submission has been kept as August 1, 2014. The funding decisions are expected to be taken by no later than December 1, 2014. Potential projects will be funded by IC-IMPACTS in Canada, and by DBT in India. The joint projects must meet the requirements of the funding organizations. In India, the general funding terms of DBT will be applied. In Canada, the general funding terms of IC-IMPACTS and the tri-agency granting councils of Canada will be applied. The DBT IC-IMPACTS partnership has been designed to strengthen existing, and stimulate new, innovation collaborations between researchers working in India and Canada and to stimulate entrepreneurial deployment of research outcomes into community contexts. Through this collaboration, IC-IMPACTS and DBT will support the innovation communities of Canada and India by each committing $1.5 million (Canadian dollars / equivalent Indian Rupees) to the joint funding of collaborative research projects submitted through this joint call for proposals. The partnership between DBT and IC-IMPACTS aims to achieve four objectives including to foster international research and innovation partnerships focused on initiatives that will have direct, deployable outcomes and technologies to benefit citizens in communities in India and Canada; to showcase Canadian and Indian research and industrial innovation to each nation and accelerate the transfer of knowledge and technologies; to develop innovation and knowledge transfer skills through the training of graduate, doctoral and post-doctoral students participating in research projects and through extended skill development activities focused on research excellence, entrepreneurial training, and knowledge transfer and commercialization expertise, thus producing the next generation of research innovators who have the essential skills to move research discoveries from laboratories into the community; and, to strengthen overall research and innovation relationships between Canada and India and through these partnerships extend Canadian and Indian innovation leadership. ]]> <![CDATA[Strategic research a must says Dr Ayyappan ]]> https://biospectrumindia.com/news/95/3789/strategic-research-a-must-says-dr-ayyappan-.html https://biospectrumindia.com/news/95/3789/strategic-research-a-must-says-dr-ayyappan-.html Thu, 01 May 2014 11:18:00 +0530 "For every single rupee invested in last five years so far in technology and research in India, Rs 13 have been recovered as the end result due to product development or output", mentioned Dr S. Ayyappan , secretary, Department of Agricultural Research & Education (DARE) and DG, ICAR, government of India while referring to the National Agricultural Innovation Project (NAIP) project which he thinks has served as a catalyst to bring about changes. He was speaking to the BioSpectrum's Rahul Koul on the sidelines of a press meeting to explain the achievements of The World Bank and government India funded NAIP. The meeting was organized by the International Crops Research Institute for the Semi-Arid Tropics (ICRISAT) and Indian Council of Agricultural Research (ICAR). "This project has given critical approach to do the capacity building to tackle problems created due to climatic changes," Dr Ayappan said. Speaking further on the partnerships and priorities, the head of ICAR, mentioned, "It is not just about money but the mutual advantage that comes due to collaboration with the World Bank. India is the first country to bring about the agriculture innovation and very few countries have this kind of krishi vigyan kendra (KVK) model. Infrastructure development and value chain is our top priority. Value chain was brought as a business aspect. The introduction of Sustainable Rural Livelihood component can lead to increase in farmer's income." "All the major stakeholders, scientists, agri-incubators, farmers and government as policy maker, have to play an important role. The future of science lies in the mix of technology, research, policy, investments. We cannot rely only on foreign technologies. We now need home grown technologies for Indian agriculture to progress and march into future," added Dr Ayappan ]]> <![CDATA[WHO report: Antibiotic resistance poses serious threat to public health]]> https://biospectrumindia.com/reports-white-papers/95/3787/who-report-antibiotic-resistance-poses-serious-threat-to-public-health.html https://biospectrumindia.com/reports-white-papers/95/3787/who-report-antibiotic-resistance-poses-serious-threat-to-public-health.html Thu, 01 May 2014 08:48:31 +0530 A new report by the World Health Organization (WHO) - the first to look at antibiotic resistance globally mentions that antibiotic resistance that occurs when bacteria change so antibiotics no longer work in people who need them to treat infections, is now a major threat to public health. It reveals that the this resistant bacteria has the potential to affect anyone, of any age, in any country. "Without urgent, coordinated action by many stakeholders, the world is headed for a post-antibiotic era, in which common infections and minor injuries which have been treatable for decades can once again kill," says Dr Keiji Fukuda, WHO's Assistant Director-General for Health Security. "Effective antibiotics have been one of the pillars allowing us to live longer, live healthier, and benefit from modern medicine. Unless we take significant actions to improve efforts to prevent infections and also change how we produce, prescribe and use antibiotics, the world will lose more and more of these global public health goods and the implications will be devastating." The report, Antimicrobial resistance: global report on surveillance, notes that resistance is occurring across many different infectious agents but the report focuses on antibiotic resistance in nine different bacteria responsible for common, serious diseases such as bloodstream infections (sepsis), diarrhoea, pneumonia, urinary tract infections and gonorrhoea. The results are cause for high concern, documenting resistance to antibiotics, especially "last resort" antibiotics, in all regions of the world. Key findings from the report include: â€¢ Resistance to the treatment of last resort for life-threatening infections caused by a common intestinal bacteria, Klebsiella pneumonia - carbapenem antibiotics - has spread to all regions of the world. K. pneumoniae is a major cause of hospital-acquired infections such as pneumonia, bloodstream infections, infections in newborns and intensive-care unit patients. In some countries, because of resistance, carbapenem antibiotics would not work in more than half of people treated for K. pneumoniae infections. Resistance to one of the most widely used antibiotics for the treatment of urinary tract infections caused by E. coli - fluoroquinolones - is very widespread. In the 1980s, when these drugs were first introduced, resistance was virtually zero. Today, there are countries in many parts of the world where this treatment is now ineffective in more than half of patients.â€¢ Treatment failure to the last resort of treatment for gonorrhea - third generation cephalosporins - has been confirmed in Austria, Australia, Canada, France, Japan, Norway, South Africa, Slovenia, Sweden and the United Kingdom. More than 1 million people are infected with gonorrhoea around the world every day. â€¢ Antibiotic resistance causes people to be sick for longer and increases the risk of death. For example, people with MRSA (methicillin-resistant Staphylococcus aureus) are 64% more likely to die than people with a non-resistant form of the infection. Resistance also increases the cost of health care with lengthier stays in hospital and more intensive care required. ]]> <![CDATA[Sun-Ranbaxy merger on hold: Indian High Court]]> https://biospectrumindia.com/news/95/3570/sun-ranbaxy-merger-on-hold-indian-high-court.html https://biospectrumindia.com/news/95/3570/sun-ranbaxy-merger-on-hold-indian-high-court.html Wed, 30 Apr 2014 15:01:35 +0530 Bangalore: In what was being dubbed to be one of the biggest consolidation attempt in the Indian pharmaceutical industry, the Sun Pharma-Ranbaxy merger has now being put on hold. Following a petition filed by Andhra Pradesh investors in Ranbaxy, the Andhra Pradesh High Court has issued an interim stay on the merger of Ranbaxy with Sun Pharma. "There shall be interim status quo, as prayed for," Justice P Naveen Rao said in his order issued in response to the petition. The petitioners had requested the High Court to grant an interim stay as they suspect insider trading in Ranbaxy shares before the merger with Sun Pharma was announced on April 6. They requested the court to direct the Sebi to investigate the alleged insider trading and also to restrain stock exchanges from clearing to the merger of Ranbaxy with Sun Pharma. As per the statement submitted to the court, more than 70 lakh Ranbaxy shares were traded before the merger was announced, pushing the share price by over 25 percent. Sun Pharma spokesman is said to have informed the media that the High Court did not hear them before issuing the order. "We have not received any such communication. The matter related to purchase of shares of Ranbaxy does not violate insider trading rules. With regards to the petition filed, the matter is sub judice and hence we cannot make specific comments but we would be taking appropriate action as advised by our legal counsel," the spokesman said. The two pharma companies, the Securities and Exchange Board of India, National Stock Exchange, Bombay Stock Exchange and Silverstreet Developers have been served notices by the court and asked to explain their actions. Silverstreet is a limited-liability partnership owned by two subsidiaries of Sun Pharma. Sun Pharma has maintained that the matter related to purchase of shares of Ranbaxy Laboratories does not violate insider trading rules. ]]> <![CDATA[One third of world's unimmunized children in India]]> https://biospectrumindia.com/news/95/8202/one-third-of-worlds-unimmunized-children-in-india.html https://biospectrumindia.com/news/95/8202/one-third-of-worlds-unimmunized-children-in-india.html Wed, 30 Apr 2014 13:51:00 +0530 Bangalore: Marking the start of the World Immunization Week, the Hilleman Laboratories, an equal joint-venture partnership formed between Merck & Co. and Wellcome Trust, announce their innovative technological intervention, thermo stability to help improve coverage of the Routine Immunization Program in India. With the vision to achieve 95 percent coverage of Expanded Program of Immunization in India which will merit 70 - 80 million doses annually, Hilleman Laboratories is bringing in innovation to act as a catalyst in bridging the gap between academia and product development by increasing the efficiency of existing vaccines with heat stable, easy to use, affordable and novel packaging features. Commenting on the current immunization scenario, Dr Davinder Gill, ceo, Hilleman Laboratories said, "With a quarter of the current birth cohort left unimmunized in the country, India severely lags behind even when compared with lesser developed nations as well as its immediate neighbours. We aim to compliment the current ecosystem and help expand the supply chain, adding scale and lowering the manufacturing cost; making the existing vaccines accessible and affordable for the unimmunized in India and other developing nations." According to WHO, 70 percent of the world's 22.6 million unimmunized children live in 12 nations; with India home to the largest chunk of 6.9 million. According to the Immunization Report by UNICEF and WHO, against the 67 percent cover in India, our neighbours boasts a much higher coverage with Sri Lanka topping the list at 97 percent followed by Bangladesh at 95 percent, Bhutan at 92 percent, Pakistan at 88 percent and Nepal at 85 percent. The solution to amplify this figure lies in distributing life-saving vaccines without the requirement for large bulk shipments, expensive warehousing and costly, difficult-to-maintain refrigerated shipping paths from the manufacturing plant to the patient, currently spearheaded by Hilleman Laboratories. One of the key breakthrough results the company presents is about the thermo-stable property of vaccines enabling it to withstand tough temperature conditions of countries in Asia and Africa. Though vaccines have transformed public health throughout the world, for children in particular, the burden of vaccine preventable disease in India is still substantial. Close to 2 million Indians died of vaccine preventable diseases in 2012. The grim irony translates from the fact that India is the largest producer of vaccines in the world. ]]> <![CDATA[Beckman to acquire cytometer developer Xitogen]]> https://biospectrumindia.com/news/95/3511/beckman-to-acquire-cytometer-developer-xitogen.html https://biospectrumindia.com/news/95/3511/beckman-to-acquire-cytometer-developer-xitogen.html Wed, 30 Apr 2014 12:38:00 +0530 Beckman Coulter Life Sciences has entered into an agreement to acquire Xitogen Technologies Inc. together with Cytojene Corporation. Xitogen, a flow cytometer developer based in Suzhou and Dalian, China, will provide Beckman Coulter Life Sciences with both a strong operational base in the growing China market and a high quality research instrument to round out their world-class cytometry offering. The acquisition is subject to customary closing conditions and is expected to close in the second quarter of 2014. Xitogen has developed the XTG-1600, a small footprint cytometer that can detect objects in the 100 nanometer range - viruses, bacteria, microparticles and cell organelles - making it an excellent choice for basic research investigations. The base single-laser/four-channel system can be incrementally expanded to a three-laser/16-channel configuration. The acquisition of the Xitogen business includes fully staffed facilities in Suzhou and Dalian, which will function as research and development and manufacturing centers for Beckman Coulter Life Sciences. "We see Xitogen's technology as an accelerator that will rapidly grow our menu of products and services," stated Jennifer Honeycutt, president of Beckman Coulter Life Sciences. "We believe that Xitogen offers significant synergies within several of our strategic focus areas, which will help to advance our mission of delivering innovative and trusted scientific solutions across the globe." "Having an operational base in the growing Asian market will enable us to provide timely service to customers in that region," said Mario Koksch, vice president and general manager of the Cytometry Business Unit for Beckman Coulter Life Sciences. "Adding this technology and intellectual property to our existing portfolio means we can extend our reach from clinical diagnostics through clinical research and further into basic research." "We believe that flow cytometers should be easy to use, able to grow with the technical needs of the users, and provide the highest quality and performance," said Dr. Yong Chen, founder of Xitogen. "We're proud our technology will be part of the Beckman Coulter portfolio, and excited about the prospects created by having access to their sales and distribution channels." Beckman Coulter Life Sciences offers a comprehensive line of cellular analysis products, including the industry-leading Navios and FC 500 clinical cytometers, the Gallios and CyAn research cytometers, and the MoFlo XDP and Astrios EQ cell sorters. Other products include sample preparation systems, Kaluza software and a full line of fluorescently-labelled antibodies and associated support products. ]]> <![CDATA[Abbott launches 'Quick Cooling Action' DIGENE ]]> https://biospectrumindia.com/news/95/7662/abbott-launches-quick-cooling-action-digene-.html https://biospectrumindia.com/news/95/7662/abbott-launches-quick-cooling-action-digene-.html Wed, 30 Apr 2014 12:37:00 +0530 Abbott, one of the largest diversified global healthcare companies in India, announced the launch of its all-new Digene range with 'Quick Cooling Action' and enhanced taste profile which provides quick relief from symptoms like acidity, gas, heartburn, bloated stomach and related uneasiness.The all-new Digene range is now available in four flavors: Mint, Orange, Mixed Fruit and Strawberry across leading chemist and retail outlets in India. It comes atan affordably priced tablet form available at Re. 1 per tablet, and a gel form priced at Rs 71 for a bottle of 170 ml. In a study done with Digene Gel and six commercially available antacids in India, Digene emerged to have the highest Acid Neutralizing Capacity (ANC), neutralizing more acid than the other compared antacids. "Today's changing lifestyle habits mean that people are rushing through meals, eating irregularly and inappropriately. This leads to an increase in symptoms of acidity and gas. Consumer research suggests that sufferers of acidity and gas look for quick and effective relief from these symptomswhich in turn lead to their well-being. Research also suggested that the mostlooked-for sensory experience is a cooling effect. The new Digene with 'Quick Cooling Action' provides consumers with quick and effective relief from these symptoms", says Rehan A. Khan, managing director, Abbott India Limited. "Abbott believes good health is the starting point for living better. With a heritage of over 100 years in India, Abbott brings relevant solutions to the marketwhichaddress Indian consumers' healthcare needs, unique tastes and preferences, delivering an'in-India for-India' approach," he added. The antacid and anti-flatulence market in India is valued at Rs 557 Crores, growing at a CAGR of 10 percent (2009-2013). The Gastroenterology segment contributes about 11 percent to the overall Indian pharmaceutical market. Digene is the number 1 doctor prescribed antacid in India and is trusted by Indian consumers for over the past 70 years to provide fast, symptomatic relief from heartburn and gas. ]]> <![CDATA[Scientists find new point of attack on HIV for vaccine development]]> https://biospectrumindia.com/news/95/7862/scientists-find-new-point-of-attack-on-hiv-for-vaccine-development.html https://biospectrumindia.com/news/95/7862/scientists-find-new-point-of-attack-on-hiv-for-vaccine-development.html Wed, 30 Apr 2014 10:46:00 +0530 "HIV has very few known sites of vulnerability, but in this work we've described a new one, and we expect it will be useful in developing a vaccine," said Dennis R Burton, professor in TSRI's Department of Immunology and Microbial Science and scientific director of the IAVI Neutralizing Antibody Center (NAC) and of the National Institutes of Health's Center for HIV/AIDS Vaccine Immunology and Immunogen Discovery (CHAVI-ID). The discovered new vulnerable site on HIV can be now attacked by antibodies to prevent infection from a broad range of the virus' many variants. "HIV mutates very quickly, within the individual and across populations," said IAVI Chief Scientific Officer Wayne Koff. "This new target offers a stable mark for vaccine design, increasing the potential to find a vaccine that can provide broad, lasting protection to people around the world." The findings, reported in two studies published online today and in the May issue of Immunity, are part of a large effort sponsored by IAVI and the U.S. National Institutes of Health (NIH) to develop AIDS vaccines that can trigger the human immune system to produce broadly neutralizing antibodies (bNAbs). Since 2009, researchers have: determined that a small proportion of HIV-infected individuals naturally generate bNAbs against a wide range of HIV variants; isolated scores of these bNAbs; identified a handful of regions they target on HIV; and found they can prevent HIV infection in non-human primates. The next step is to design immunogens to elicit these bNAbs in humans. In the first study, a team of scientists from TSRI, IAVI and Theraclone Sciences, led by Dr Burton, identified and described a promising new set of bNAbs, the PGT151 series, building on the Protocol G project that studied HIV-infected people who naturally produce bNAbs. The researchers found that two of the antibodies in the series could block infection by more than two-thirds of HIV strains found in patients worldwide. In the second study, a team led by Ian A Wilson, TSRI Hansen Professor of Structural Biology and chair of the Department of Integrative Structural and Computational Biology, explored the newly identified target, which becomes the fifth well-characterized epitope, or binding site, on the surface of HIV. ]]> <![CDATA[Frost & Sullivan to honor exemplary world-class achievers]]> https://biospectrumindia.com/news/95/7044/frost-sullivan-to-honor-exemplary-world-class-achievers.html https://biospectrumindia.com/news/95/7044/frost-sullivan-to-honor-exemplary-world-class-achievers.html Wed, 30 Apr 2014 10:43:00 +0530 Frost & Sullivan has announced that its 6th Annual India Healthcare Excellence Awards 2014 will be held on September 19 2014, in Mumbai, India. The coveted Awards platform evaluates companies on their outstanding performance in the healthcare and life sciences sector. It recognizes companies that have demonstrated best practices in the Indian Healthcare Market. The last date for sending nomination has been kept as June 30th, 2014. The past five years have witnessed major hospitals and companies like Apollo Hospitals, Fortis Healthcare, Wockhardt Hospital, Medanta The Medicity, SRL Ltd, Metropolis, Narayana Hrudayalaya, Dr. Batra's Positive Health Clinic, 3M Healthcare, Abbott, B. Braun, Fresenius, Bharat Serums, GE Healthcare, Getinge, Glaxo Smithkline Pharmaceuticals, Novo Nordisk, Philips Healthcare, Roche Diagnostics, Siemens Healthcare, Siro Clinpharm, and Sun Pharmaceutical, among others becoming a part of this burgeoning fraternity of excellence. Frost & Sullivan's Annual India Healthcare Excellence Awards program recognizes companies for their superior planning, leadership, strategy, growth, innovation, integration, marketing, and financial performance. A host of other crucial factors such as strategic alliances, distribution strategies, execution of product launches, technological innovations, customer service, and mergers and acquisitions are also considered as part of the Awards methodology. For five consecutive years since 2009, Frost & Sullivan has been successful in recognizing and applauding the success of organizations and individuals for their contributions to the healthcare industry. Mr Sandeep Sinha, Director, Healthcare Practice, Frost & Sullivan said, "Over the years, the Frost & Sullivan Annual India Healthcare Excellence Award has become an industry benchmark and is attended by the who's who in the healthcare industry. The overwhelming support and encouragement from the industry motivates us to be committed to our goal in recognizing the achievers, who are working towards making the country a healthier and productive nation through their products and services." The Indian healthcare industry, valued at approximately US $90.0 billion in 2014, is expected to reach $160.0 billion by 2017, with a 15 percent annual growth. The country's existing healthcare infrastructure is however, irregularly distributed; access to good healthcare facilities, doctors, diagnostic centers, and laboratories is concentrated in urban areas where only 25-30 percent of the population resides. In addition, India's healthcare model also ranks relatively low on vital parameters like health expenditure (as a percentage of GDP), hospital bed-population ratios and infant and maternal mortality ratio among others. Despite these challenges, what makes this sector's growth inevitable are the concurrent efforts in infrastructure development, progressing privatization, public-private partnership models, a strong low cost manufacturing pharmacology sector, increasing applications of e-health and m-health coupled with the aggressive launch of innovative insurance, reimbursement, and financing policies to complete the circle of the end user, payer, and provider value chain. The 2014 edition of Frost & Sullivan's 6th annual India Healthcare Excellence Awards will witness eminent names compete for the most coveted titles in the Indian healthcare industry. The Awards procedure involves an esteemed panel of judges, who follow a rigorous methodology in shortlisting and thereafter selecting the organizations that are transforming the Indian healthcare industry. Frost & Sullivan's Annual India Healthcare Excellence Awards banquet in the past has a proudly hosted industry veterans like Dr Pratap C. Reddy - Apollo Hospitals, Dr Naresh Trehan - Medanta Medicity, Dr Somaraju - Care Hospitals, Dr Habil Khorakiwala - Wockhardt Group, Dr K Ravindranath - Global Hospitals, Dr Ajai Kumar - HCG, Dr. Mukesh Batra - Dr Batra Homeopathy Clinics, Dr S K Sarin - Indian Medical Association, Mr A K Purwar - India Infoline Investment Services Ltd, Dr Sanjeev K Chaudhry - SRL, Ms Ameera Patel - Metropolis, Mr D G Shah - Indian Pharmaceutical Alliance, Dr Bhavin Jankharia - Indian Radiology & Imaging Association. The award titles that would be recognized at the Frost & Sullivan 6th Annual India Healthcare Excellence Awards 2014 will span across all major healthcare industry sectors like Medical Technologies, Healthcare IT, Healthcare Delivery/ Services, Pharmaceuticals, and Biotechnology. ]]> <![CDATA[Glenmark's novel monoclonal antibody GBR 900 entering human trials]]> https://biospectrumindia.com/news/95/8357/glenmarks-novel-monoclonal-antibody-gbr-900-entering-human-trials.html https://biospectrumindia.com/news/95/8357/glenmarks-novel-monoclonal-antibody-gbr-900-entering-human-trials.html Tue, 29 Apr 2014 15:36:27 +0530 Glenmark Pharmaceuticals S.A., a wholly owned Swiss subsidiary of Glenmark Pharmaceuticals Ltd., announced today that GBR 900, a novel monoclonal antibody is entering human trials. GBR 900 targets TrkA, a receptor for nerve growth factor (NGF) involved in chronic pain signaling. In 2010, Glenmark gained an exclusive worldwide license from Lay Line Genomics S.p.A. (Italy) for anti-TrkA antibodies and their entire intellectual property portfolio in the TrkA field. GBR 900 is the optimized anti-TrkA antibody emerging from this exclusive worldwide license. Glenmark has now completed the Phase I enabling preclinical development programme for GBR 900 and has filed a Phase I clinical trial application with the MHRA, UK. GBR 900 is the first anti-TrkA monoclonal antibody to enter clinical development. TrkA is the pain-signalling receptor for NGF. Monoclonal antibodies directed against NGF represent one of the rare clinical breakthroughs in chronic pain treatment and have shown excellent clinical activity in inflammatory and neuropathic pain. Unfortunately, development of the class has been curtailed due to suspected toxicity. In the GLP toxicity studies no dose limiting toxicities were detected with GBR 900, even at high doses tested. This potentially differentiates GBR 900 from anti-NGF antibodies which are dose limited in clinical studies by preclinical toxicity findings at low doses.Preclinical head to head comparisons with anti-NGF antibodies in animal models of inflammatory pain demonstrated that GBR 900's efficacy profile compares favorably with anti-NGF antibodies. Commenting on the progress with GBR 900, Dr. Michael Buschle, president of Biologics and chief scientific officer, Glenmark Pharmaceuticals Ltd. said: "Since we licensed the TrkA IP from Lay Line Genomics we have been able to differentiate GBR 900 from anti-NGF antibodies. We are very excited about the Phase I clinical study starting and expect that this study will extend the preclinical differentiation into a drug which will be clinically differentiated from anti-NGF antibodies." "We are extremely pleased that Glenmark has made significant progress with the anti-TrkA project and are excited about the potential start of the first clinical trial of GBR 900," said Ennio Esposito, sole director at Lay Line Genomics S.p.A ., Italy. ]]> <![CDATA[Clinical development: Quintiles and Biogen Idec ink pact ]]> https://biospectrumindia.com/news/95/7605/clinical-development-quintiles-and-biogen-idec-ink-pact-.html https://biospectrumindia.com/news/95/7605/clinical-development-quintiles-and-biogen-idec-ink-pact-.html Tue, 29 Apr 2014 14:07:46 +0530 The multi-year collaboration is designed to leverage the expertise and experience from both organizations to optimize Biogen Idec's clinical development processes. According to Quintiles' media statement, the collaboration is structured to increase clinical trial efficiency, with a focus on transparency, quality, innovation and operational excellence. "Our partnership with Biogen Idec exemplifies the ongoing evolution of drug development collaboration and reinforces the increasingly important role that biopharmaceutical service providers such as Quintiles have in these efforts," said Mr Tom Pike, chief executive officer, Quintiles. "We are extremely excited about this agreement and the increased interest we are seeing for these types of innovative development deals. We believe Quintiles is uniquely positioned to help our customers improve their probability of success through these collaborations, and we look forward to working closely with Biogen Idec." Under the agreement, a dedicated team from Quintiles will work with Biogen Idec on the design, planning and execution of Biogen Idec's phase II-IV studies and select phase I studies. In addition, Biogen Idec will leverage Quintiles' technology and systems across its growing portfolio. "As we have continued to build our research and development organization, it was important for us to identify a strong clinical development partner to complement our focus on developing innovative therapies for the treatment of neurodegenerative, hematologic and autoimmune diseases," said Dr Alfred Sandrock, group senior vice president, development sciences and chief medical officer, Biogen Idec. "What attracted us to Quintiles was their depth and breadth of experience, which we believe will enhance the design, planning and operational elements of our clinical programs." The Biogen Idec and Quintiles collaboration is already underway. New projects are being initiated through the collaboration, and several of Biogen Idec's ongoing studies are currently transitioning to Quintiles. ]]> <![CDATA[Alembic Pharmaceuticals Net sales up by 23%]]> https://biospectrumindia.com/news/95/3678/alembic-pharmaceuticals-net-sales-up-by-23.html https://biospectrumindia.com/news/95/3678/alembic-pharmaceuticals-net-sales-up-by-23.html Tue, 29 Apr 2014 13:54:00 +0530 Alembic Pharmaceuticals Limited reported a 23 percent increase in revenues to Rs 465.2 crore for the quarter ended 31st March 2014, compared to Rs 378.4 crores in the corresponding quarter last year. The company posted 46 percent growth in profit before tax at Rs 80.8 crore for the quarter ended 31st March 2014 against Rs 55.2 crore posted in the corresponding quarter last fiscal.The net profit grew by 40 percent at Rs 61.3 crore for the quarter ended 31st March 2014 against Rs 43.7 crores in corresponding quarter last fiscal. EBIDTA margins for quarter ended 31st March 2014 up at 19.6 percent to Rs 91.3 crore from 17.3 percent at Rs 65.6 crore for corresponding quarter last year. The company also reported 22 percent increase in revenue for Year ended 31st March 2014 to Rs 1868.4 crore against Rs 1526.0 crore for last year. The company also posted 51 growth in profit before tax at Rs 310.6 crore for year ended 31st March 2014 against Rs 206.4 crore for last year. The company also reported 43 percent growth in net profit for year ended 31st March 2014 at Rs 235.5 crores against Rs 165.3 crores last year. The Board has recommended dividend on equity shares at Rs 3.00 per share i.e. 150 percent for 13-14 (P.Y. Re. 2.50 per share i.e. 125 percent) The India Branded formulations business posted sales of Rs 199.5 crore against Rs 175.3 crore with a 14 percent growth over the corresponding quarter of the previous year. The India Branded formulations business posted sales for year ended 31st March 2014 of Rs 850.6 crore against Rs 748.4 crore with a 14 percent growth over the previous year. ]]> <![CDATA[Bilcare receives National Intellectual Property Award 2014 by DIPP]]> https://biospectrumindia.com/news/95/6660/bilcare-receives-national-intellectual-property-award-2014-by-dipp.html https://biospectrumindia.com/news/95/6660/bilcare-receives-national-intellectual-property-award-2014-by-dipp.html Tue, 29 Apr 2014 09:41:00 +0530 Bilcare Research has been awarded the National Intellectual Property Award 2014 by Government of India. This award is conferred to recognize and reward innovators of IP who have contributed to harnessing the country's intellectual capital and creating an eco-system that boots creativity and innovation. Dr Praful R Naik, executive rirector, Bilcare was felicitated by Mr Amitabh Kant, secretary, Department of Industrial Policy and Promotion (DIPP) at a function held on 26 April 2014, the World Intellectual Property Day, jointly organized by CII and the Government of India. While receiving the award, Dr Naik said: "Bilcare continual investment in innovation pathway and R&D has lead to creation of portfolio of novel products, processes and services as well as path breaking technologies, like nonClonableID (nCiD) technology which not only finds its place in product securitization for global pharmaceuticals but also application in e- governance initiatives in myriad government and non government sectors." Bilcare has contributed to harness the country's intellectual capital and created an eco-system that's boosts creativity and innovation. The strong research orientation to Customer centric Innovations, Research and Development, has resulted in continual creation of valuable Intellectual Property in the form of Novel products and services and the path-breaking technology solution-nonClonableID technology (over 200 patent applications and 36 granted patents world-wide) resulting in global leadership with over 1000 pharmaceutical companies as well other industrial sectors. Bilcarenon ClonableID (nCiD)technology was approved for a crucial national project by the Council of Scientific and Industrial Research under its prestigious New Millennium Indian Technology leadership Initiative Program entitled "Customized Adaptation of nonClonableID Technology to Establish Authenticity of Medical Products and Facilitate Improving Medication Compliance by Patients". Intellectual Property Office, Govt. of India under the Department of Industrial Policy and Promotion of Ministry of Commerce and Industry, Government of India selects the organizations and individuals for their outstanding contribution to Intellectual Property in the country, every year. ]]> <![CDATA[Supreme court asks why open field trials of GM crops not be banned]]> https://biospectrumindia.com/news/95/5727/supreme-court-asks-why-open-field-trials-of-gm-crops-not-be-banned.html https://biospectrumindia.com/news/95/5727/supreme-court-asks-why-open-field-trials-of-gm-crops-not-be-banned.html Mon, 28 Apr 2014 17:09:00 +0530 Why there should not be an interim suspension of open field trials of genetically modified crops in view of an expert committee disfavouring it? This was the question asked by the Supreme Court on April 22, 2014 to the union government. According to media reports quoting Press Trust of India, the bench headed by justice HL Dattu observed, "We have reports of responsible persons who occupy responsible positions. Don't you think there should be an interim order (against open field trials) till we hear this case?" However, the bench, also comprising justice SA Bobde clarified that it was not inclined to halt trial in closed environment or isolated conditions. The anti-GM activists represented by advocate Prashant Bhushan, submitted that open field trials should be banned till a strong regulatory regime was in place. Mr Bhushan cited the 2012 report of the court-appointed expert committee recommending the ban and the report of the Parliamentary Standing Committee to buttress the argument that experts were of the opinion that a moratorium should be imposed on open field trials till regulatory regime was put in place. However, additional solicitor general Paras Kuhat mentioned that all recommendations of the expert committees were "virtually" in place and the community of Indian and international scientists was in favour of allowing GM crops' field trials. "We will set the clock at least 10 years back (if field trials are banned). Scientist won't conduct studies in adverse regimes," he reportedly said. Earlier the apex court in November 2012 had refused to impose an interim ban on their field trials despite the court-appointed expert committee recommending the ban. In July 2013, the activists had requested the Supreme Court to accept the final report of its technical expert committee while "ignoring" any findings by its member and former DG of Indian Council of Agriculture Research (ICAR), Dr RS Paroda, alleging that he had "conflict of interest" on the issue. The affidavit filed by activist Aruna Rodrigues, who had sought a complete moratorium on field trial of GMO, had said the final report and documents by the expert committee (TEC) recommended no field trials till regulatory gaps are addressed as there have been serious shortcomings in the GMO regulatory process. ]]> <![CDATA[SRL introduces breakthrough technique to predict heart failure ]]> https://biospectrumindia.com/news/95/6478/srl-introduces-breakthrough-technique-to-predict-heart-failure-.html https://biospectrumindia.com/news/95/6478/srl-introduces-breakthrough-technique-to-predict-heart-failure-.html Mon, 28 Apr 2014 16:14:00 +0530 Knowing if you're about to have a heart failure is now possible. With an endeavour to provide accurate solutions with ethical standards and care, SRL Diagnostics Limited (SRL), the largest diagnostics network in India, announced the launch of new lab test- ST2, to help predict risks of coronary heart disease by finding a specific biomarker in the bloodstream. SRL Diagnostics is the first ever diagnostic lab in India to have launched this key medical test, available across India at all Fortis Labs/ SRL Diagnostics Labs and its collection centres for just Rs 1600. Speaking on the occasion, Dr B R Das, president-research and innovation, mentor-molecular pathology and clinical research services, SRL Diagnostics Ltd said, "ST2 is the only marker available in India for predicting prognosis in heart failure cases and SRL Diagnostics is the only service provider of this medical test in the country. Unlike many other cardiac biomarkers, ST2 is faster thus helping physicians make informed decisions on an appropriate course of action to take and, if needed, to quickly adjust treatment. It can reduce 30 day rehospitalisation rates by 17.3 percent and also reduce 30-day mortality rates by 17.6 percent." Recent evidence has reported the incidence of cardiovascular disease (CVD) to be 50 percent to 40 percent higher in Asian Indians than individuals of other ethnic origins. In addition, some 30 percent to 40 percent of cardiovascular deaths occur between 35 and 64 years of age. The prevalence of heart failure in India due to coronary heart disease, hypertension, obesity, diabetes and rheumatic heart disease to range from 1.3 to 4.6 million, with an annual incidence of 4,91,600-1.8 million. "ST2 is ELISA based test which is a US FDA approved technology and was included in 2013 ACC/AHA guidelines for the management of heart failure. It has been extensively evaluated with more than 100 peer reviewed articles and scientific posters studying more than 35,000 patients. So far, SRL Diagnostics has collected 100 samples for the predicting the heart failure" Dr Das further added. The American College of Cardiology Foundation and the American Heart Association Task Force jointly released their expanded clinical practice guideline for the management of patients with heart failure and has identified ST2 'not only predictive of hospitalization and death in patients with heart failure but also additive to natriuretic peptide levels in its prognostic value.' SRL consistently follows the best of National and International Quality protocols, thereby ensuring accuracy of every test report. ]]> <![CDATA[India's pharma export growth slowest in 15 years ]]> https://biospectrumindia.com/news/95/3421/indias-pharma-export-growth-slowest-in-15-years-.html https://biospectrumindia.com/news/95/3421/indias-pharma-export-growth-slowest-in-15-years-.html Sat, 26 Apr 2014 13:31:22 +0530 Bangalore: The Indian pharmaceutical industry exports have registered slowest growth in at least 15 years, a news report explained. At 1.2 percent growth, to $14.84 billion last fiscal, regulatory issues and the increasing tension with the US over intellectual property rights have resulted in the slump. The industry is said to miss the target of $25 billion that was set for this fiscal. The government strategy paper had set the target of $25 billion for pharma exports during 2014-15. According to the Commerce Ministry data, in 2012-13, the country's pharma exports aggregated $14.66 billion. The growth registered in 2013-14 is the slowest in nearly 15 years. The previous slowest was in 2009-10 when the pharma exports grew by just 5.9 per cent. In calendar year 2000, they grew by 7 per cent. "2013-14 has seen slowdown in growth because of the U.S. raising concerns and due to increase in global competition," Mr PV Appaji, executive director, Pharmexcil told PTI. The US accounts for about 25 percent of India's pharma exports but shadowed by regulatory issues, the Indian industry is now facing a turbulent growth period. With further Indian patent process troubles for the industry, reports said that analysts are predicting more slow growth. ]]> <![CDATA[Innovating R&D]]> https://biospectrumindia.com/views/95/3281/innovating-rd.html https://biospectrumindia.com/views/95/3281/innovating-rd.html Sat, 26 Apr 2014 13:00:37 +0530 Bangalore: The entrepreneurial ventures pioneered in the period before the year 2000 were built in the harsh realities of non-availability of funds and business models, and were being pioneered to stay afloat in most parts of Asia. "We did not have a choice," said several of the early biotech entrepreneurs. Since there was no venture capital, early start-ups had to focus on business revenues. They had to offer products and services. Then they set up manufacturing for today and set aside a sum of profits for tomorrow's products and services. Now they are considering working on products for patients of tomorrow. And the rise of generics has led to adoption of innovation and R&D in India in specific. The current set of enterprises that have been launched in the last three-four years are working on innovation-driven platform technologies and most of these enterprises are coming through a VC generation. Investors have backed the model. They need to raise more rounds. And they believe that it's equally important to have intervention of the governments. The focus is now on partnerships with others to launch products. Sharing the costs and risks in novel therapeutics is beneficial for both. According to a recent CPhI Pharma Insights report, the R&D market is diversifying innovation, with increasing partnerships, mergers and revenue sharing models. The report suggests a highly positive outlook across the R&D sector with growth in R&D spending predicted at over 8 percent for the next year, which contrasts sharply with falling returns on investment experienced over the last few years by the majority of the industry. The R&D market has seen the greatest of changes over the last 10 years within the industry. "With big pharma wrestling to adapt a formerly successful model that each year is producing decreased levels of output, we are now amidst the middle of the cycle with a move away from investing in single large-scale R&D sites to diversifying interests across geographic regions, technologies and partnering firms," observes the report. This approach is leading itself to increased open innovation, out-licencing and in-licencing of technology, and outsourcing models that drive down development costs and even partnering and profit sharing arrangements." Though cancer research is the biggest pie for R&D budgets, combination drugs and personalized medicines are key novel focus areas for R&D (at 37 percent and 20 percent respectively). These findings are supported by the survey results reflecting that cancer is the main focus area for 2014. VCs have not yet invested heavily in biotech and there is a lack of confidence in the investor community about the investment climate in most parts of Asia and the capabilities of the entrepreneurs. What is very interesting is that the governments are now building cohesive ecosystems for biotech and multiple venture capital firms in order to help increase the levels of innovation, entrepreneurial zeal, industry- academia interface, and support funding and mentoring. This kind of an ecosystem is unparalleled and it is time that the investors' confidence is restored with better awareness and meaningful discussions. According to Mr Venkatadri Bobba, General Partner at Ventureast Fund Advisors India Ltd, the best is yet to come for BioPharma as there are no clear drug products from Human Genome Project as yet and there are no clear therapeutic paths to individual genomic based pharmacotherapy. The Playbook will be to enhance skills, leverage global expertise through partnerships, focus on biosimilars, bio-betters, or validated targets; and plan for success and failure. ]]> <![CDATA[Vietnam bans drugs from 45 Indian pharma firms]]> https://biospectrumindia.com/news/95/3030/vietnam-bans-drugs-from-45-indian-pharma-firms.html https://biospectrumindia.com/news/95/3030/vietnam-bans-drugs-from-45-indian-pharma-firms.html Sat, 26 Apr 2014 10:30:25 +0530 Claiming that the drugs supplied by at least 45 Indian pharmaceutical companies are not of standard quality (NSQ), the Drug Administration of Vietnam (DAV) has banned drugs by these firms on its land. Some major Indian drug makers like Strides Arcolab, Medley Pharmaceuticals, Marck Biosciences, Marksans Pharma and UMedica Laboratories are also part of the list of banned drug makers. News reports specified that all the companies in the banned list failed the DAV quality tests between January 1, 2011 and October 25, 2013. Vietnam has also banned drugs from nine Korean companies, two companies from Bangladesh, two from France, and one each from the US, Philippines, Pakistan, Russia, Indonesia, Germany, Cyprus, and Canada. As per Indian health ministry sources, India is one of the largest suppliers of medicines to South-East Asian countries like Vietnam and African countries like Kenya, Nigeria and Ghana. Mr Deepak Mittal, the Indian consul general in Vietnam is said to have written a strongly worded letter to the ministry of health and family welfare. Copies of the letter have been sent to the external affairs ministry, the department of commerce, the Indian embassy in Hanoi and to the office of the Drug Controller General of India (DCGI). Mr Mittal has said in his letter, "In view of the fact that a large number of Indian companies have been listed defaulters by Vietnamese authorities, it is requested that necessary background checks on these companies may kindly be undertaken in India to see if there are complaints against them from other countries and steps be initiated to penalise them for bringing bad name to the Indian pharma industries abroad." A drug is declared NSQ if the active pharmaceutical ingredient (API) in it is lesser than the declared amount. In such a case, the efficacy of the drug goes down. The other parameters that are checked are the quality of bonding agent, colouring agent, and the time taken for dissolution. But this is not the first time Vietnam has banned Indian companies. About two years ago, it had banned 19 pharma companies on the same ground, the health ministry source said. Mr T R Gopalakrishnan, advisor, Indian Drug Manufacturers' Association (IDMA) told news media that, "Vietnam depends on India for procuring drugs. In recent years, Chinese interference in the markets has been observed. But China is not yet at par with India in manufacturing finished drugs. It should be noted that Vietnam hasn't banned any Chinese company." Mr DG Shah, the president of the Indian Pharmaceutical Alliance (IPA), however said, "Vietnam sources drugs at the cheapest price. And quality is bound to suffer. But if big pharma companies are figuring in the list then regulatory authorities should inspect the quality of their injectibles, tablets, capsules and syrups." ]]> <![CDATA[Jubilant receives ANDA approval for Spironolactone ]]> https://biospectrumindia.com/news/95/3136/jubilant-receives-anda-approval-for-spironolactone-.html https://biospectrumindia.com/news/95/3136/jubilant-receives-anda-approval-for-spironolactone-.html Fri, 25 Apr 2014 16:43:00 +0530 Jubilant Life Sciences, an integrated Pharmaceuticals and Life Sciences Company announced that it has received Abbreviated New Drug Application (ANDA) approval from the US Food and Drug Administration (US FDA) for Spironolactone Tablets, 25 mg, 50 mg and 100 mg, the generic version of Aldactone (of GD Searle), which is used as a diuretic to treat fluid retention (edema) caused by congestive heart failure and cirrhosis of the liver. We expect to launch this product in Q1 FY15.The total market size for Spironolactone Tabletsas per IMS is US$ 87Million per annum. Jubilant has also received a tentative approval from the USFDA for Memantine Tablets, 5 mg and 10 mg, the generic version of Namenda (of Forest Labs), which is used for treatment of moderate-to-severe Alzheimer's disease. We expect to launch this product post patent expiry in 2015. The total market size for Namenda as per IMS is US$ 1.85 Billion per annum. As on December 31, 2013, Jubilant Life Sciences had a total of 689 filings for formulations of which 230 have been approved in various regions globally. This includes 60 ANDAs filed in the US and 42 Dossier filings in Europe. ]]> <![CDATA[India home to one third of world's unimmunized children]]> https://biospectrumindia.com/news/95/3683/india-home-to-one-third-of-worlds-unimmunized-children.html https://biospectrumindia.com/news/95/3683/india-home-to-one-third-of-worlds-unimmunized-children.html Fri, 25 Apr 2014 16:26:13 +0530 Marking the start of the World Immunization Week, the Hilleman Laboratories, an equal joint-venture partnership formed between Merck & Co. and Wellcome Trust, announce their innovative technological intervention, thermo stability to help improve coverage of the Routine Immunization Program in India. With the vision to achieve 95% coverage of Expanded Program of Immunization in India which will merit 70 - 80 million doses annually, Hilleman Laboratories is bringing in innovation to act as a catalyst in bridging the gap between academia and product development by increasing the efficiency of existing vaccines with heat stable, easy to use, affordable and novel packaging features. Commenting on the current immunization scenario, Dr. Davinder Gill, ceo, Hilleman Laboratories said, "With a quarter of the current birth cohort left unimmunized in the country, India severely lags behind even when compared with lesser developed nations as well as its immediate neighbours. We aim to compliment the current ecosystem and help expand the supply chain, adding scale and lowering the manufacturing cost; making the existing vaccines accessible and affordable for the unimmunized in India and other developing nations." According to WHO, 70% of the world's 22.6 million unimmunized children live in 12 nations; with India home to the largest chunk of 6.9 million. According to the Immunization Report by UNICEF and WHO, against the 67% cover in India, our neighbours boasts a much higher coverage with Sri Lanka topping the list at 97% followed by Bangladesh at 95%, Bhutan at 92%, Pakistan at 88% and Nepal at 85%. The solution to amplify this figure lies in distributing life-saving vaccines without the requirement for large bulk shipments, expensive warehousing and costly, difficult-to-maintain refrigerated shipping paths from the manufacturing plant to the patient, currently spearheaded by Hilleman Laboratories. One of the key breakthrough results the company presents is about the thermo-stable property of vaccines enabling it to withstand tough temperature conditions of countries in Asia and Africa. Though vaccines have transformed public health throughout the world, for children in particular, the burden of vaccine preventable disease in India is still substantial. Close to 2 million Indians died of vaccine preventable diseases in 2012. The grim irony translates from the fact that India is the largest producer of vaccines in the world. ]]> <![CDATA[Biocon registers 16% growth]]> https://biospectrumindia.com/news/95/3327/biocon-registers-16-growth.html https://biospectrumindia.com/news/95/3327/biocon-registers-16-growth.html Fri, 25 Apr 2014 09:12:00 +0530 India's leading biotech conglomerate Biocon records 16% revenue growth in FY14. The companies revenues for the period April 2013-March 2014 stood at â‚¹ 2,933 crore with an of EBITDA â‚¹743 crore. The PAT for the period was â‚¹ 414 crore. Commenting on the quarterly performance and highlights, Chairman and Managing Director, Kiran Mazumdar-Shaw stated, "Biocon ended fiscal 2014 on a strong note. We delivered 16 percent revenue growth along with a healthy EBITDA Margin of 25%. This fiscal we recorded robust performance, an outcome of our efforts aimed at optimising our product mix, augmenting capacities and driving operational efficiencies. We have delivered on our promise of affordable innovation through commercialization of Alzumab, an anti-CD6 novel biologic for Psoriasis; and CANMAb, the world's most affordable trastuzumab. We are pleased that a large number of patients benefitted from these two products." The R&D investments of company stood at â‚¹131 Crores (6% of Biopharma Segment sales) . The comany also announced the elevation of Dr Arun Chandavarkar to Chief Executive Officer and Joint Managing Director and appointment of Mr Ravi Limaye, as president - marketing, Biocon. ]]> <![CDATA[Narayana Health city showcases efficacy of bone marrow transplants]]> https://biospectrumindia.com/news/95/7496/narayana-health-city-showcases-efficacy-of-bone-marrow-transplants.html https://biospectrumindia.com/news/95/7496/narayana-health-city-showcases-efficacy-of-bone-marrow-transplants.html Thu, 24 Apr 2014 16:06:01 +0530 Narayana Health City Bangalore with over 300 successful Bone Marrow Transplants to its credit, today, showcased the efficacy of this treatment modality with over 80% success rate for curing cancerous and genetic blood diseases. Bone Marrow Transplant is a highly advanced procedure that involves transfusion of bone marrow stem cells from a healthy donor to a patient. There are three sources of donors from where the bone marrow can be collected - *related donor, matched unrelated donor and haploidentical donor. "The nature of blood diseases/ disorders is either genetic in nature or acquired due to exposure to several risk factors including hazardous environment and consumption of adulterated food", said, Dr. Sharat Damodar, hod & senior consultant hematologist, Bone Marrow Transplant Unit, Narayana Health City." He further added, "Bone Marrow Transplants are now producing high success rates as it is curative in nature and offers hope to patients of a life beyond painful and fatal diseases." Speaking about the constraints in finding donors in India, he said, "However in India, it is a challenge to find donors and we should consider it as our social responsibility to volunteer for donating healthy bone marrow and help patients in need." Dr. Damodar and his team of experts also presented and shared cases of patients who have been in remission for five years and even more and leading a disease free life post Bone Marrow Transplantation. A 30-year-old teacher was admitted with chronic myelogenous leukemia (CML) in blast crisis with the only match option being a bone marrow transplant. Luckily, her sister's bone marrow matched and the patient underwent bone marrow transplant, which has cured her completely. She is now doing well and comes for follow-up. 7-year-old boy underwent bone marrow transplant for Thalassemia; now 14-year-old has recovered and is back to school. Thalassemia is the inherited blood disorder which causes the body to make less hemoglobin. The treatment option for thalassemia involves regular blood transfusions, bone marrow transplant being the most effective cure. Narayana Health City is the only hospital in India to have partnered with 'Cure Thalassemia' (an organization consisting of renowned doctors who pioneered 'Bone marrow transplant' for thalassemia patients from Italy). Another seven-year-old boy suffering from severe life threatening infection - aplastic anemia was referred to Narayana Health City for curative treatment. His three-year-old sister donated the stem cells for his treatment and the boy is now healthy and doing his engineering. His blood group was changed after this transplantation. Aplastic Anemia refers to a medical term for bone marrow failure, when the quantity of each of the three blood cell types is much lower than normal. The symptoms are unexplained infections (due to fewer white blood cells), unexpected bleeding (due to fewer platelets) and fatigue (due to fewer red blood cells). The treatment for aplastic anemia include blood transfusion, blood and marrow stem cell transplants. Narayana Health City Bangalore has India's largest Bone Marrow Transplant Unit with around 30% of patients coming from overseas. The unit was established with a vision to make this treatment affordable to the common man. Since then the BMT unit has completed more than 300 bone marrow transplants with 70% of them being allogeneic stem cell transplants. ]]> <![CDATA[WHO calls for greater investment in the battle against malaria]]> https://biospectrumindia.com/news/95/7955/who-calls-for-greater-investment-in-the-battle-against-malaria.html https://biospectrumindia.com/news/95/7955/who-calls-for-greater-investment-in-the-battle-against-malaria.html Thu, 24 Apr 2014 15:57:00 +0530 Three out of four people are at risk of malaria in WHO's South-East Asia Region, which is home to a quarter of the world's population. Even though the number of confirmed malaria cases in the Region decreased from 2.9 million in 2000 to 2 million in 2012, the disease remains a significant threat to the lives and livelihoods of people. Ahead of World Malaria Day (25th April), the WHO has urged for more investment towards malaria control and elimination programs. With emergence of increasing parasite resistance to drugs & insecticide, malaria poses a serious threat to public health in the region. "1.4 billion People continue to be at risk of malaria in South-East Asia. They are often the poorest, including workers in hilly or forested areas, in development projects such as mining, agroforestry, road and dam constructions, and upland subsistence farming in rural areas and urban areas," said Dr Poonam Khetrapal Singh, WHO Regional Director for South-East Asia. "We must continue surveillance for malaria. Funding needs to be increased for diagnostics, drugs, insecticide-treated mosquito nets, and research and response to drug and insecticide resistance. We need to empower communities to protect themselves. Eliminating malaria will take greater political will." Bangladesh, Bhutan, Democratic People's Republic of Korea, Nepal, and Sri Lanka reduced the incidence of malaria cases by more than 75% from 2000 to 2012. Thailand and Timor-Leste are on track to achieve a decrease of over 75%. India is expected to decrease malaria case incidence by 50-75% by 2015. Sri Lanka is in the elimination phase; the country has had no indigenous cases since November 2012, down from 203 000 cases in 2000. Maldives has been malaria-free since 1984. Global efforts to control and eliminate malaria have saved an estimated 3.3 million lives. Between 2000 and 2012, malaria mortality rates have been reduced by 42% and the incidence of malaria has decreased by 25% globally. But the gains in malaria control, although substantial, could be reversed due to increasing parasite resistance to drugs, mosquito resistance to insecticides and re-introduction of transmission in places where the disease has been eliminated. The emergence of artemisinin resistance in Cambodia, Myanmar, Thailand and Viet Nam threatens the global achievements in malaria control and elimination. Artemisinin-based combination treatment (ACT) is currently the first line treatment for the most lethal type of malaria, Plasmodium falciparum. Resistance to this drug would compromise the lives of hundreds of thousands of people affected with malaria, and there is an urgent need to invest in ways to contain the spread of resistance to these drugs. Another danger lies in the fact that the Anopheles mosquitoes, which carry malaria parasites, are increasingly become resistant to insecticides. There is a need to contain the emergence and spread of resistance of Anopheles mosquitoes to insecticides. Moreover, re-introduction of transmission in areas free of malaria is always a threat if surveillance and rapid response are not sustained. Investments are needed to develop new tools, to conduct operational research to address bottlenecks in malaria control programmes, and to scale-up and ensure rational use of existing interventions. There is also a need to further strengthen health systems and mobilize multisectoral actions to accelerate progress towards elimination of malaria as a public health problem.______________ ]]> <![CDATA[Medwell Ventures in India to launch speciality home healthcare]]> https://biospectrumindia.com/news/95/7875/medwell-ventures-in-india-to-launch-speciality-home-healthcare.html https://biospectrumindia.com/news/95/7875/medwell-ventures-in-india-to-launch-speciality-home-healthcare.html Thu, 24 Apr 2014 15:10:00 +0530 In a move that signifies the changing dynamics of the Indian Healthcare delivery landscape, two former CEOs of leading healthcare enterprises have come together with a dynamic team of professionals to launch Medwell Ventures - an innovative pan-India Healthcare delivery platform and India's first Specialty Home Healthcare company. At a press conference they announced the successful closing of their initial round of funding from the promoter group and expect to invest USD 15-20 million in this business over the next 3-5 years. They also announced the acquisition of Bangalore-based Nightingales Home Health Services, a company with an experience of 18 years in Home Healthcare. Nightingales currently provides 53000 patient bedside nursing days per annum, 24000 medical services per year and has more than 5000 families subscribing to its annual care plans. Medwell plans to expand the services of Nightingales with a Speciality Home Healthcare focus on Pulmonology, Cardiology, Metabolic diseases, Neurological health, Orthopedics, Geriatrics, Rehabilitation and Post-Operative Surgical site management. The company expects to establish a network in 10 Indian metro clusters serving over a million families in the coming years. This will be supported by a cloud-based Technology platform and protocol-driven services in specialised therapeutic areas. The novel Healthcare System will integrate different delivery channels to bring care closer to patients. Additional services will include remote health monitoring, tele-health, diagnostics, rehabilitation and wellness therapeutics which will be launched in waves. Medwell aspires to become a leader in its field through innovation and rapid growth, driven by acquisitions and organic investments in new capabilities. The company is also exploring alliances with various global Medical Technology partners in order to provide best-in-class services, particularly in the area of chronic diseases. Medwell has been co-promoted by Vishal Bali former group ceo, Fortis Healthcare, who has spent 24 yrs in building Healthcare delivery institutions and Cytespace Research Private Limited, a research-based company in the Healthcare domain. "India's challenges in Healthcare delivery need innovative answers. More than 40 million Indians lose their lives to chronic diseases each year and a fourth are below 60 years. An ageing population, shortage of hospital beds and the need for continuity of care pre/post-hospitalization create a strong demand for professionally driven Speciality Home Healthcare services. The future of patient-centric care will incorporate Speciality Home Healthcare as a key element and our team is excited to launch a pioneering new venture in this space" said, Vishal Bali, former group ceo, Fortis Healthcare. Dr. Ferzaan Engineer, chairman of Cytespace Research, said "Medwell Ventures will change the paradigm of Healthcare delivery in the country, introduce global best practices and enable the roll-out of scalable Home Healthcare services across the country. A strong and experienced leadership team has been established to fulfil our shared vision for the company and we see a billion dollar growth opportunity in this space." Mr. Pai, a member of the Medwell founding team is the CEO of the new company. He is also a co-founder of Cytespace and during the course of his career has led the Global Data Management business at Quintiles Transnational besides holding senior positions in the IT and Consulting industries. The ethos of Nightingales emphasises impeccable customer service, trust and integrity. These patient-centric values will be nurtured while adding significant resources and investment in medical and technological expertise, protocol and process development, training and multi-city capabilities. "In my experience, Speciality Home Healthcare can add significantly to clinical effectiveness and improve patient outcomes. Clinicians are increasingly seeing this service as an integral part of the continuum of care that they need to provide their patients" said Dr. Murthy, a medical doctor who is credited with doing pioneering work in geriatric Home Healthcare in the country. India's estimated USD 2 billion Home Healthcare market will mirror the exponential growth in other countries, specifically the USA and UK. The Home Healthcare market in North America is estimated to be USD 130 billion and the European Home Healthcare market will be worth USD 57 billion by 2017 with Germany, France and UK dominating the requirement. ]]> <![CDATA[Bhutan has brought health to centre stage of development: Dr Khetrapal]]> https://biospectrumindia.com/news/95/7854/bhutan-has-brought-health-to-centre-stage-of-development-dr-khetrapal.html https://biospectrumindia.com/news/95/7854/bhutan-has-brought-health-to-centre-stage-of-development-dr-khetrapal.html Wed, 23 Apr 2014 15:59:12 +0530 The World Health Organization is bringing together international public health experts, development agencies and academia to share experiences and identify quick wins for universal health coverage (UHC) at a Conference on Advancing Universal Health Coverage in South-East Asia in Paro. Bhutan has made significant progress in all three dimensions of UHC. A recent assessment completed by the Ministry of Health shows Bhutan's health system provides over 75% coverage with the majority of the population having access to good-quality services, health workers, medicines and technologies, without causing them financial hardship. "Bhutan, as for other countries of the Region, now needs to strengthen efforts to counter the increasing burden of noncommunicable diseases, especially through preventive activities that are low-cost and sustainable," said Dr Poonam Khetrapal Singh, Regional Director WHO South-East Asia. Dr Khetrapal Singh is on her first official visit to Bhutan as Regional Director of the WHO South-East Asia Region. She prioritized universal health coverage and robust health systems in her vision statement as one of four strategic areas for WHO's work in the Region. Other strategic areas in her vision statement are: addressing persisting and emerging epidemiological and demographic challenges; strengthening emergency risk management for sustainable development; and articulating a strong Regional voice in the global health agenda. Highlighting Bhutan's role in global health, Dr Khetrapal Singh said "Bhutan has brought human well-being to centre stage of the development debate." Bhutan convened a High Level Meeting at the United Nations in New York in April 2012 to discuss a shift in the focus of international development from measuring improvements in Gross National Product to indicators of Gross National Happiness. Subsequently, the post-2015 development debate has focused on well-being as the core objective of the next international compact, with health as a key component. The WHO Conference will share international experience on equitable financing for health systems so that people can get the care they need without being pushed into poverty. In South-East Asia, out-of-pocket payments for health are the highest among all the WHO regions and one-third of new annual poverty is health related. Discussions will also focus on access to affordable medicines and human resources, issues that are relevant for effective service delivery both in Bhutan as well as other countries of the Region. The Conference is expected to agree on the way forward for WHO's work to advance universal health coverage in the Region. ]]> <![CDATA[Lupin inks strategic JV agreement with Yoshindo]]> https://biospectrumindia.com/news/95/3782/lupin-inks-strategic-jv-agreement-with-yoshindo.html https://biospectrumindia.com/news/95/3782/lupin-inks-strategic-jv-agreement-with-yoshindo.html Wed, 23 Apr 2014 13:46:00 +0530 Pharma Major, Lupin Limited announced today that it has entered into a strategic joint venture agreement with Toyama based Japanese pharmaceuticals company, Yoshindo Inc. (Yoshindo) to create a new entity, YL Biologics (YLB). YLB will be jointly managed by both partners and will be responsible for conducting clinical development of certain Biosimilars including regulatory filings and obtaining marketing authorizations in Japan. The new entity YLB will in-license Monoclonal Antibodies (mAbs) from Lupin and also partner with other companies across the globe for the Japanese market which already has a clear cut regulatory regime in place for the development and commercialization of Biologicals. Lupin's Etanercept biosimilar, developed by its Biotechnology Research Group in Pune will be the first product to be licensed for clinical development to YLB. Etanercept (Originator Trade name: Enbrel®) is a biopharmaceutical product approved globally for treating autoimmune diseases such as Rheumatoid arthritis, Psoriasis and Ankylosing spondylitis. Enbrel is marketed in Japan by Takeda Pharmaceutical and had sales of $496 million (IMS MAT March, 2013). The Japanese Biological market is currently valued at close to $12 billion and growing at 2-3 percent annually. mAbs make up $3.5 billion of the overall Japanese biological sales and growing at 5 percent (IMS Health). Lupin will be entitled to milestone based licensing income in addition to commercial supplies of the drug substance. Both Lupin and Yoshindo will then market the product under their own brand names by leveraging their respective sales networks. Commenting on the joint venture Dr Kamal K Sharma, vice chairman, Lupin Limited said, "We are very excited about the joint venture with Yoshindo, a partner who shares our commitment to bringing biosimilars to market in Japan. YLB is a reflection of Lupin's long-term commitment to the Japanese market and is an important first step forward to establishing Lupin's global Biosimilar portfolio". Commenting on the JV, Mr Kenzo Shimomura, president, Yoshindo said, "YL Biologics is our bridgehead to expand Yoshindo's activities to the Biosimilar market in Japan and highlight on the strategic representation of company. We are very pleased to enter into a strong partnership with Lupin which will make it possible to jointly develop a meaningful biosimilar product pipeline for the Japanese market". ]]> <![CDATA[Global conference on animal nutrition held]]> https://biospectrumindia.com/news/95/7969/global-conference-on-animal-nutrition-held.html https://biospectrumindia.com/news/95/7969/global-conference-on-animal-nutrition-held.html Wed, 23 Apr 2014 12:44:22 +0530 The importance of livestock sector in India's economy and livelihood security of marginal farmers cannot be underestimated. Keeping that in view, the global animal nutrition conference organized at Bangalore, saw deliberations on the subject of improvement in animal nutrition. Dr S Ayyappan, Secretary DARE and DG, ICAR who presided over the function, asked the scientific and development agencies to address the wide gap in demand and supply of feed and fodder in the country. Dr Ayappan mentioned further, "We have to tap new feed resources and improvise the utilisation of different agricultural byproducts as quality animal feeds." This three day conference is being organised by 'Animal Nutrition Society of India' with the collaboration of National Institute of Animal Nutrition and Physiology, Compound Livestock Feed Manufacturer's Association and VIV India. Matters related to novel feed resources, improving feed utilization , feed quality and ensuring food security in the changing climate scenario will be discussed during this global conference being attended by more than 400 delegates from India and abroad. Dr Amrita Patel, Former Chairperson, NDDB, Dr Purvi Mehta-Bhatt from ILRI, Dr K.M.L Pathak, DDG (Animal Sciences) were the guests of honour. ]]> <![CDATA[Sigvaris appoints NovoMed as distributor in India]]> https://biospectrumindia.com/news/95/3767/sigvaris-appoints-novomed-as-distributor-in-india.html https://biospectrumindia.com/news/95/3767/sigvaris-appoints-novomed-as-distributor-in-india.html Wed, 23 Apr 2014 10:24:00 +0530 Sigvaris, a leading international medical device company and the world's pioneer in compression garments including hosiery and socks today officially appointed NovoMed Incorporation Pvt. Ltd. exclusively as its distribution partners in India. Sigvaris is the world's leading manufacturer of graduated compression stockings which are clinically proven to be preventive as well as therapeutic in the treatment of Deep Vein Thrombosis (DVT), varicose veins, help improve circulation and revive tired, achy legs. In layman terms, DVT is a clot that develops in the peripheral veins of the limbs. It is often a precursor to a potentially fatal condition known as Pulmonary Embolism (PE) where the blood clot in the peripheral circulation breaks loose, travels to the lungs, lodges In the circulatory system and compromises heart and lung function. Speaking about the association, Nainesh Mehta,managing director, NovoMed Incorporation Pvt. Ltd, said, "We are proud to associate with Sigvaris who have attained global presence and recognitionby staying true to their values of perfection, quality and precision." ]]> <![CDATA[Lupin appoints Theresa Stevens as chief corporate development officer]]> https://biospectrumindia.com/news/95/3780/lupin-appoints-theresa-stevens-as-chief-corporate-development-officer.html https://biospectrumindia.com/news/95/3780/lupin-appoints-theresa-stevens-as-chief-corporate-development-officer.html Tue, 22 Apr 2014 16:08:37 +0530 Pharma major Lupin announced the appointment of Theresa Stevens as Chief Corporate Development Officer for its global operations. Ms Stevens will assume full responsibility for global merger and acquisitions and specialty business strategy. Prior to joining Lupin, she was with Aptalis pharma as the chief corporate development officer responsible for Mergers and Acquisitions (M&A), Strategy and Global Business Development. Before Aptalis, Ms Stevens was in Novartis for 9+ years and held positions of increasing responsibility including head, Global BD&L for General Medicines, executive director and head, Global BD&L for Respiratory and Dermatology Business Units and head US Business Development and Licensing, life cycle management and generic brand strategies. Ms Stevens has a Masters Degree in Biochemistry from University of Maryland and is a Juris Doctor (J.D) from the Widener University School of Law, Wilmington, Delaware. She started her career as a research scientist at Dupont and has practiced Corporate Law at Pennie and Edmonds (Jones Day). Having worked with Aptalis and Novartis, Ms Stevens has over 27 years of experience in the Pharmaceutical and Biotech sector with significant experience in managing strategy, corporate development, M&A and licensing. Commenting on the appointment, Nilesh Gupta, managing director, Lupin Limited said, "I am very pleased to welcome Theresa to the Lupin family. I am sure her rich experience in the areas of M&A and Specialty Strategy within the pharmaceutical and biotech industry sector will help Lupin's growth plans." ]]> <![CDATA[Jubilant Life Sciences to participate in VIV India 2014]]> https://biospectrumindia.com/news/95/3776/jubilant-life-sciences-to-participate-in-viv-india-2014.html https://biospectrumindia.com/news/95/3776/jubilant-life-sciences-to-participate-in-viv-india-2014.html Tue, 22 Apr 2014 15:24:00 +0530 Jubilant Life Sciences, the worldwide second largest manufacturer of Niacinamide and Niacin (Vitamin B3) will be participating in VIV India 2014. The exhibition to be held over 2 days, 23rd-24th April at BIEC, Bengaluru, India brings together different sectors in animal production and processing. At VIV India, Jubilant aims to introduce several of its existing products to the industry players in animal nutrition and feed category. Visit Jubilant Stallat A062 to meet officials from the Company. Jubilant's Niacinamide and Niacin (Vitamin B3) finds multiple applications in Animal Nutrition, Human Nutrition, Pharmaceuticals, Cosmeceuticals, Technical Applications and Agrochemicals. Thecomplete backward integration, (Molasses - Alcohol - Acetaldehyde - Pyridine or Beta Picoline - Niacinamide/Niacin) up to the basic feedstock, is one of the major advantages that the company has over the othermanufacturers of Niacinamide and Niacin. Jubilant's Animal Nutrition products are widely used in poultry, dairy, pet food and the veterinary drugs industry. The manufacturing facilities of Jubilant meet global standards and are certifiedfor major regulatory certifications such asKOSHER, Halal, FAMI-QS and cGMP regulations. Jubilant Life Sciences is also India's largest manufacturer of Synthetic Choline Chloride. This compound is used to create products that are offered in different forms for animal feed applications, all of which duly meet international quality standards. Choline Chloride is used in: Poultry, Dairy, Pet food and Pharmaceuticals with Choline enriched products. In speciality products, Jubilant offers Specialty Feed Supplements to farmers across the globe, thus helping them to continuously increase their returns on investments, which are mainly Vitamin and Minerals Premixes, Betaine, Organic Mineral Premix, Acidifiers, Toxin Binders, Chromium based Growth Promoter, Feed Emulsifier and Liver Treatment Products. Jubilant has a broad range of product portfolio in Nutrition Ingredients. Portfolio includes: â€¢ AciFeed - Feed Acidifier for mould & bacteria inhibitionâ€¢ BGTMDS/MultiminPlus - Trace Mineral Premixesâ€¢ EnCroMix - Organic Tri-Chromium preparation for energy utilisationâ€¢ Hi Feed Phytase - Hi Performance Thermo-tolerant Micro-granulated Phytaseâ€¢ Hi-Pro-Min-Organic Mineral premix for poultryâ€¢ JubiDOL - Feed emulsifierâ€¢ OsmoBetaine - Betaine for osmo-regulation in livestockâ€¢ ToxiCOP/Protect Plus - Broad spectrum mould and Mycotoxin binderâ€¢ WinTox - Liquid formulation for nourishment, detoxification and rejuvenation of vital organs ]]> <![CDATA[Novartis acquires GSK's oncology products]]> https://biospectrumindia.com/news/95/5758/novartis-acquires-gsks-oncology-products.html https://biospectrumindia.com/news/95/5758/novartis-acquires-gsks-oncology-products.html Tue, 22 Apr 2014 13:07:00 +0530 Novartis announced today that it has reached a definitive agreement with GlaxoSmithKline plc (GSK) to exchange certain assets, build global leadership in key segments and focus on the company's portfolio. Under the agreement, Novartis would strengthen the company's innovative pharmaceuticals business by acquiring GSK oncology products, and would divest Vaccines (excluding flu) to them. The two companies would also create a joint venture, combining their consumer divisions to create a world-leading consumer healthcare business. Separately, the company announced a definitive agreement with Eli Lilly and Company (Lilly) to divest the Animal Health Division, further focusing its portfolio on the leading businesses of innovative pharmaceuticals, eye care and generics. "The transactions mark a transformational moment for Novartis. They focus the company on leading businesses with innovation power and global scale. They also improve our financial strength, and are expected to add to our growth rates and margins immediately," said Joseph Jimenez, ceo of Novartis. He further added "We have also created a world-leading consumer healthcare business in our joint venture with GSK. We believe the divestment of our smaller Vaccines and Animal Health Divisions will enable us to realize immediate value from these businesses for our shareholders, and those divisions will benefit from being part of large, global businesses that are also leaders in their segments. Looking ahead, this positions Novartis well for future healthcare industry dynamics." ]]> <![CDATA[Strand Life Sciences partners with Mazumdar-Shaw Medical Foundation ]]> https://biospectrumindia.com/news/95/5166/strand-life-sciences-partners-with-mazumdar-shaw-medical-foundation-.html https://biospectrumindia.com/news/95/5166/strand-life-sciences-partners-with-mazumdar-shaw-medical-foundation-.html Mon, 21 Apr 2014 18:32:59 +0530 Strand, a global life sciences & clinical genomics company headquartered in Bangalore, entered into a partnership with the Mazumdar-Shaw Medical Foundation (MSMF) to set up the Strand at Mazumdar-Shaw (SAMS) translational lab in the Mazumdar-Shaw Centre for Translational Research (MSCTR) in Bangalore. This is a major milestone towards enabling an ecosystem of personalized medical treatment for patients with cancer and other genetic diseases. "It gives us great pleasure to partner with Strand Life Sciences, a pioneer in genomics and personalized medicine. With evolving healthcare systems, it is imperative that we are constantly innovating and developing capabilities that will provide personalized treatment and quality care to the people of India. We believe this collaboration will help us foster innovation and encourage in-depth research in the genomics space and thereby provide better care for patients with cancer and other genetic diseases," said Dr Kiran Mazumdar-Shaw, CMD, Biocon. Based on statistics, nearly seven lakh Indians die of cancer every year, while over 10 lakh are newly diagnosed with some form of the disease. According to the latest World Cancer Report from the World Health Organization (WHO), there are over 4.77 lakh men and 5.37 lakh women diagnosed with cancer in India in 2012 alone. The scale of these challenges requires the Indian healthcare industry to use affordability as a driver of innovation. Strand through its expertise will offer comprehensive genomic testing for cancer and other germline or hereditary conditions at highly affordable costs. In addition, the collaboration will also entail promoting research in the field of genomics, conducting medical and non-medical programs, seminars and talks shows, assisting clinicians and scientists in performing quality research, and towards making genomics research resources and data available to scientists. Talking about this partnership, Dr Vijay Chandru, Chairman & CEO, Strand Life Sciences said, "The Mazumdar-Shaw Medical Foundation has shown great foresight and magnanimity in helping us work towards the goal of providing the leading edge of genomic medicine at affordable prices in India and elsewhere. This collaboration provides Strand with an exciting opportunity to conduct and promote in-depth research in the field of genomic sequencing based diagnostics." He further added, "This partnership is recognition of our joint commitment to bringing best-in-class healthcare technologies closer to people in India at affordable costs. As part of the vision laid out in the partnership, Strand has developed an affordable Hereditary Breast Cancer Diagnostic Test that will cost significantly less than comparable tests available in the West and India. This is the first of many innovations that we will develop at the SAMS translational lab" ]]> <![CDATA[Cervical cancer vaccines: will our best hopes be realized?]]> https://biospectrumindia.com/news/95/3144/cervical-cancer-vaccines-will-our-best-hopes-be-realized.html https://biospectrumindia.com/news/95/3144/cervical-cancer-vaccines-will-our-best-hopes-be-realized.html Mon, 21 Apr 2014 12:24:22 +0530 Our worst fear back in 2006-when the human papillomavirus (HPV) vaccine against cervical cancer finally came to market at a whopping $120 per dose-was that the girls who most needed it would be the ones least likely to get it. More than 85 percent of cervical cancer cases occur in low- and middle-income countries, especially in Africa and Asia. Those same countries find it difficult to offer screening services, like Pap smears and HPV tests, that have nearly eliminated cervical cancer in wealthy countries. How would these countries ever be able to afford an expensive vaccine? Furthermore, could immunization programs geared to vaccinating babies effectively reach young adolescent girls? And would parents' concern about cervical cancer caused by HPV override their hesitation to mention a sexually transmitted infection to their young daughters? Easing the way for immunization The GAVI Alliance, an international organization that helps low-resource countries introduce needed new vaccines, greatly eased the first problem when they began offering HPV vaccine in 2012. Using the power of bulk purchasing, GAVI and UNICEF worked together to get the vaccine at a lower price. GAVI offered it to qualified countries for 20 cents a dose-and sometimes for free. Meanwhile, groundbreaking work by PATH to understand cultural issues and to demonstrate and evaluate strategies for delivering the vaccine helped answer the other questions. Yes, the countries could reach the right girls and yes, once they understood the issue, parents would flock to protect their daughters against a deadly cancer. Spared from cervical cancer Our best hopes-that politicians who determine health budgets would be courageous, forward-thinking, and willing to invest in the future of women since it will take decades for the reduction in cancer to be apparent-are now being realized. Although GAVI projected relatively modest demand from countries in the vaccine's initial years-in large part because the countries were busy introducing other important vaccines against severe diarrhea and pneumonia-in fact, applications requesting HPV vaccine began pouring in. As a result, over the past two years more than 20 low- and lower-middle income countries have been approved by GAVI for HPV vaccine demonstration projects, and four countries in Africa are already introducing the vaccine nationally. Schoolgirls are lining up for shots that will spare them the agonizing deaths they have seen among their grannies, aunties, and moms. Healthy future for millions of women As World Immunization Week approaches, I've been thinking about how much this scene has changed in the past decade. Ten years ago there was no HPV vaccine. Now many countries, even low-income ones, are building a healthy foundation for the futures of millions of women-women who are key producers, managers, teachers, and leaders and who deserve the same chance as women in wealthier countries to live free from a deadly yet mostly preventable disease. Granted, there still is a lot of work to do-not only to ensure that all girls receive the vaccine, but also to make certain that all women are screened for cervical precancer and treated as needed. But it is clear that a base of support is growing among political leaders willing to bring about these changes. And, most importantly, there is strong demand from parents and communities worldwide for a vaccine with the potential to save millions of women in the coming decades. ]]> <![CDATA[Pfizer eyeing to buy AstraZeneca?]]> https://biospectrumindia.com/news/95/3142/pfizer-eyeing-to-buy-astrazeneca.html https://biospectrumindia.com/news/95/3142/pfizer-eyeing-to-buy-astrazeneca.html Mon, 21 Apr 2014 12:18:34 +0530 The paper cited senior investment bankers and industry sources saying that informal conversations about a deal had taken place between the two but that no talks were currently under way after AstraZeneca resisted the approach. Pfizer and AstraZeneca both declined to comment on the report to Reuters. AstraZeneca, Britain's second-biggest pharmaceuticals group, has been frequently touted as a potential takeover target as it wrestles with patents expiring on a number of best-selling drugs, leaving future growth uncertain. Despite these problems, the company has attracted attention for experimental cancer drugs it is developing, which could be interesting for Pfizer which has faced patent losses of its own, notably anti-cholesterol treatment Lipitor. The two firms are familiar with each other's products working together on projects such as the pioneering of a new kind of clinical trial for cancer drugs announced last week. Pfizer could use cash it has accumulated through overseas subsidiaries, which if repatriated to the U.S. would be heavily taxed. In the past Swiss drug firm Novartis and larger British peer GlaxoSmithKline have been mentioned as potential suitors, although GSK has publicly said it is not interested in making a large acquisition in recent years. AstraZeneca, which announces first quarter results on Thursday, has a market valuation of around $80 billion, compared with Pfizer - valued at $193 billion, according to Thomson Reuters data. Earnings at AstraZeneca fell 6 percent in the fourth quarter of 2013, and the drugmaker has said it expects them to keep falling in 2014 as generic competition to Nexium, its popular heartburn and ulcer drug, takes a big bite out of U.S. profits from late May. AstraZeneca has suffered a dry period in drug discovery in recent years and badly needs to find new medicines to replace blockbusters such as Nexium and Crestor, a treatment for high cholesterol that will lose patent protection in a few years. Pfizer's last big acquisition was in 2009, when it bought U.S. rival Wyeth for $68 billion. Source: (London: Reuters) ]]> <![CDATA[Piramal Enterprises Limited aqcuires 20% equity stake]]> https://biospectrumindia.com/news/95/3580/piramal-enterprises-limited-aqcuires-20-equity-stake.html https://biospectrumindia.com/news/95/3580/piramal-enterprises-limited-aqcuires-20-equity-stake.html Fri, 18 Apr 2014 15:22:25 +0530 Piramal Enterprises Ltd. announced that it has agreed to acquire an effective 20% equity stake in Shriram Capital Limited, a financial services company, for an aggregate consideration of Rs. 2,014 Cr. Shriram Capital Limited (SCL) is the overarching holding company for the Financial Services and Insurance entities of the Shriram Group, created with the primary objective of optimizing the synergies across the Group's entities. Shriram Capital's operating entities, have an overall customer base in excess of 9 Million, more than 53,000 employees across 2,600 offices, net profit of Rs. 800 Cr with Assets Under Management (AUM) in excess of Rs.78,000 Cr. Piramal had invested Rs. 1,636 Cr in May last year to acquire ~9.9% equity in ShriramTransport Finance Company Limited, one of the listed NBFCs forming part of the Shriram Group. Commenting on the investment, Mr. Ajay Piramal, chairman of Piramal Enterprises Limited, said "This investment builds our presence in financial services sector and we seelong term shareholder value creation from our partnership with Shriram Capital. The Company is well known for its culture and values, which resonates well with Piramal Group's philosophy." Commenting on the partnership, Mr. R. Thyagarajan, founder of Shriram Group, said "Shriram Group has pioneered providing financial services to the under-served section of the Economy. Our success over the last four decades has been possible only through strategic partnerships. Piramals' entry into Shriram Capital is a significant milestone for the Financial Services businesses to take a quantum leap in the Group's contribution to the community at large". ]]> <![CDATA[Dr Reddy's announces launch of Eszopiclone Tablets C-IV]]> https://biospectrumindia.com/news/95/4590/dr-reddys-announces-launch-of-eszopiclone-tablets-c-iv.html https://biospectrumindia.com/news/95/4590/dr-reddys-announces-launch-of-eszopiclone-tablets-c-iv.html Thu, 17 Apr 2014 12:08:00 +0530 Dr Reddy's Laboratories announced that it has launched Eszopiclone Tablets (C-IV) 1 mg, 2 mg and 3 mg, a therapeutic equivalent generic version of LUNESTA (eszopiclone) tablets C-IV in the US market on April 15, 2014, following the approval by the United States Food & Drug Administration (USFDA). The LUNESTA (eszopiclone) tablets C-IV brand and generic combined had U.S. sales of approximately $887 Million MAT for the most recent twelve months ending in January 2014 according to IMS Health*. Dr Reddy's Eszopiclone Tablets (C-IV) 1 mg is available in bottle counts of 30. Eszopiclone Tablets (C-IV) 2 mg and 3 mg are available in bottle counts of 100 ]]> <![CDATA[Dr LH Hiranandani Hospital to host IBOM 2014 in Mumbai]]> https://biospectrumindia.com/news/95/3777/dr-lh-hiranandani-hospital-to-host-ibom-2014-in-mumbai.html https://biospectrumindia.com/news/95/3777/dr-lh-hiranandani-hospital-to-host-ibom-2014-in-mumbai.html Thu, 17 Apr 2014 11:56:00 +0530 Dr L H Hiranandani Hospital will host the International Biologics Orthopaedic Meet (IBOM 2014) in Mumbai on May 30-31, 2014. The event which is scheduled to take place at Sofitel, Bandra Kurla Complex, Mumbai is a scientific meeting dedicated to the use of Biologics Orthopaedic therapy in orthopedics and sports medicine. This conference is organized in collaboration with Hiranandani Orthopaedic Medical Education (HOME), the orthopaedic research division of the Dr L H Hiranandani Hospital, and the Biological Orthopaedic Society, USA. The objective behind this initiative is to create awareness on biologics orthopaedic therapy, which is becoming a very popular treatment option in orthopaedics and sports medicine across the world.Sports medicine is a sub-specialty of orthopaedics that aims at evaluating an individual's sports capabilities. It analyzes the strengths and weaknesses of an athlete or a sports person and offer solutions accordingly. The meeting includes educational lectures from eminent national and international experts who have spent considerable time in this field. IBOM will serve as a resource pool of prominent doctors from across the globe for advanced treatment options provided to orthopaedics for best patient care. The prominent national faculty includes Anant Joshi, Ashok Johari, Deepak Goyal, Dinshaw Pardiwala, Hitesh Gopalan, Jaspal Sandhu, Mandeep Dhillon, Nicholas Antao, Roshan Wade, Sanjeev Jain, Sanjay Desai, Sachin Tapasvi, Yajuvendra Gawai, Uday Prakash and Vaibhav Bagaria. ]]> <![CDATA[Glenmark Generics receives final ANDA approval for Eszopiclone Tablets]]> https://biospectrumindia.com/news/95/7732/glenmark-generics-receives-final-anda-approval-for-eszopiclone-tablets.html https://biospectrumindia.com/news/95/7732/glenmark-generics-receives-final-anda-approval-for-eszopiclone-tablets.html Wed, 16 Apr 2014 10:44:00 +0530 Glenmark Generics Inc., USA a subsidiary of Glenmark Generics Limited has been granted final abbreviated new drug approval (ANDA) from the United States Food and Drug Administration (US FDA) for Eszopiclone Tablets. Glenmark will commence distribution of the product immediately. Eszopiclone Tablets are Glenmark's generic version of Sunovion's Lunesta®. Eszopiclone is indicated for the treatment of insomnia. The approval is for the 1mg, 2mg and 3mg tablets. For the 12 month period ending December 2013, Lunesta® garnered annual sales of USD 824 million according to IMS Health. Glenmark's current portfolio consists of 91 products authorized for distribution in the U.S. marketplace and 63 ANDA's pending approval with the U.S. FDA. In addition to these internal filings, GGI continues to identify and explore external development partnerships to supplement and accelerate the growth of the existing pipeline and portfolio. ]]> <![CDATA[Elbrit Life Sciences dreams big on Indian pharmaceutical business]]> https://biospectrumindia.com/news/95/3011/elbrit-life-sciences-dreams-big-on-indian-pharmaceutical-business.html https://biospectrumindia.com/news/95/3011/elbrit-life-sciences-dreams-big-on-indian-pharmaceutical-business.html Tue, 15 Apr 2014 14:42:07 +0530 'Elbrit Life Sciences', a new pharmaceutical company based in Mumbai, India,opened gates for business in India. The company would be serving the South Indian states initially and aims to cover the entire country with time. According to the sources, the company would be targeting cardiac and diabetes product segments in the present year. Elbrit Life Sciences is a part of a global business group based in UK with investments in science, research and education. The group has significantly invested in next generation healthcare such as genetic therapy, molecular biology, DNA mapping and biomarkers. The group also owns world renowned scientific and academic publishing brands. Speaking on the occasion, Mr. Prakash, ceo of the company said, "We are extremely excited to announce the launch of Elbrit Life Science. We will be initially venturing into branded generics in diabetic and cardiac segments. In the near future, we will be adding more innovative and super speciality products to our portfolio. Our goal is to expand into other pharmaceutical segments as well and become a leading player in the market in the times to come." Mr. Prakash, who was present during the occasion is an Indian origin executive based out in the UK. According to the sources, the parent group based in UK has invested heavily in Elbrit Life Sciences. Details related to the same are expected to be released in the coming weeks. The sources also said that the company is aggressively planning to pursue the Indian pharmaceutical space. If experts in the field are to be believed, the launch of 'Elbrit Life Sciences' is likely to change the Indian pharmaceutical sector on its head resulting in better quality and healthy competition. With the major Indian pharmaceutical companies facing tough times over quality issues in the US and Europe, healthy competition in the domestic market is an encouraging sign for patients. ]]> <![CDATA[N Rajaram appointed as new country head and general manager for Sanofi's Pharmaceutical Operations]]> https://biospectrumindia.com/news/95/1442/n-rajaram-appointed-as-new-country-head-and-general-manager-for-sanofis-pharmaceutical-operations.html https://biospectrumindia.com/news/95/1442/n-rajaram-appointed-as-new-country-head-and-general-manager-for-sanofis-pharmaceutical-operations.html Tue, 15 Apr 2014 12:56:00 +0530 Sanofi India Limited today announced the appointment of N Rajaram as country head and general manager - Pharmaceutical Operations, India with effect from April 2014. He reports to Dr Shailesh Ayyangar, vice president - South Asia, Sanofi and managing director - Sanofi India Limited. Speaking on the appointment and new organisation structure, Dr Ayyangar, commented "The healthcare industry in India is on the threshold of major transformation as we address the problem of increasing access to quality healthcare and medicines to our large population. Mr Rajaram's induction reinforces Sanofi's commitment to deliver innovative solutions to access issues. His vast experience and consumer insights will help drive Sanofi's growth strategy in India." Commenting on his new role, Mr N Rajaram, country head and general manager-Pharmaceutical Operations-Sanofi India Limited said, "This is a very exciting opportunity for me. The pharmaceutical industry is witnessing a rapid change in different aspects such as innovative healthcare delivery and patient care. The prospect of playing a responsible role in making a difference in the lives of people is very exciting and fulfilling." ]]> <![CDATA[Our job is to make strong demands says Dr Raghavan]]> https://biospectrumindia.com/news/95/8132/our-job-is-to-make-strong-demands-says-dr-raghavan.html https://biospectrumindia.com/news/95/8132/our-job-is-to-make-strong-demands-says-dr-raghavan.html Mon, 14 Apr 2014 17:12:00 +0530 "The sanitation and female foeticide are a national shame. We are trying to ensure our participation in programmes to help improve the situation. Reinventing the toilet programme can be a major entrepreneur opportunity which actually has been grabbed by many potential start-ups. Sanitation and secondary agriculture is an area where we have not dabbled," remarked Dr K Vijay Raghavan, secretary, DBT at the foundation day celebrations of the BIRAC held at New Delhi recently. Dr Raghavan while making his point on the areas of potential mentioned, "Our opportunities lie in making reagents and pathways are already available here. The chemists, biologists, doctors and engineers should be in the list of talent pool availability. Energy and ecology are the areas that must be looked at. In self-criticism, animal research has not gone far. We need to look at that as well. Entrepreneurs in the clinical research finishing schools are also a good idea." The secretary hinted that the DBT is actively looking forward to help streamline regulatory issues. "We discussed with the planning commission about eight months ago and will have a regulatory science unit at the DBT. It will help in training the regulatory professionals. Once the elections are over, the announcements will be made to this effect," Dr Raghavan said. Rightly so, the DBT secretary is of the opinion that while the political will is required to take certain decisions, it is the job of government departments to push what they feel is right. ]]> <![CDATA[Alivira Animal Health allots equity shares to Shasun Pharma]]> https://biospectrumindia.com/news/95/8051/alivira-animal-health-allots-equity-shares-to-shasun-pharma.html https://biospectrumindia.com/news/95/8051/alivira-animal-health-allots-equity-shares-to-shasun-pharma.html Mon, 14 Apr 2014 12:25:00 +0530 With reference to the earlier announcements on July 13, 2013 and March 07, 2014 regarding entering into a joint venture agreement with Sequent Scientific Limited to develop, manufacture and sell veterinary products inclusive of both API (Active Pharmaceuticals Ingredients) and formulations in the global market, Shasun Pharmaceuticals Ltd has announced The Joint Venture Company named 'Alivira Animal Health Limited' ('Alivira') has successfully completed the following actions: - Alivira Animal Health Limited has allotted 74,00,000 equity shares to Shasun Pharmaceuticals Limited in consideration for the transfer of the Shasun's Vizag Unit. - Alivira has also allotted 21,14,165 shares to Devicam Capital LLP, an enterprise jointly owned by the Promoters of Shasun Pharmaceuticals Limited and Sequent Scientific Limited for cash. ]]> <![CDATA[Novozymes enables GSK's Eperzan]]> https://biospectrumindia.com/news/95/7687/novozymes-enables-gsks-eperzan.html https://biospectrumindia.com/news/95/7687/novozymes-enables-gsks-eperzan.html Mon, 14 Apr 2014 11:13:00 +0530 The drug uses albumin technology from Novozymes to extend the drug's presence in the patient's body. Many injected treatments require daily dosing, which can be challenging for patients. Pharma companies are therefore seeking to develop longer lasting drugs that allow patients to dose less frequently. Known as VELTIS, the Novozymes technology that extends the active drug lifespan is based on albumin, a naturally occurring protein that can be found in human blood. "The first approval for a product based on Novozymes' VELTIS technology, and marketed by one of the largest pharmaceutical companies in the world, marks a significant milestone for our half-life extension technology", said Mr Thomas VidebÃ¦k, executive vice president, Novozymes. "We consider this authorization as a real proof that VELTIS can offer true benefits to patients, reducing the inconvenience associated with daily drug dosing." Albumin works as a vehicle that transports the active drug ingredients throughout the body and increases the lifespan of the drug in the patient's system. VELTIS was originally developed in baker's yeast, and the technology was acquired by Novozymes via the purchase of Delta Biotechnology based in Nottingham, UK in 2006. As in the case of GlaxoSmithKline's Eperzan, dosing just once a week means that patients can self-administer with greater ease and convenience. Simplified dosing can help patients comply with the recommended medication regimen and benefit fully from the drug. Eperzan is the first approved drug based on the Novozymes' albumin technology. Recently, Novozymes also announced a collaboration with Janssen to evaluate the albumin technology for potential new drug candidates. GlaxoSmithKline has also applied for marketing approval for Eperzan in the US. The drug is currently undergoing assessment by the US Food and Drug Administration (FDA) with a Prescription Drug User Fee Act (PDUFA) review date April 15, 2014. The authorization does not impact Novozymes' financial outlook for 2014. ]]> <![CDATA[Lupin gets FDA approval for Generic Actos ]]> https://biospectrumindia.com/news/95/5614/lupin-gets-fda-approval-for-generic-actos-.html https://biospectrumindia.com/news/95/5614/lupin-gets-fda-approval-for-generic-actos-.html Fri, 11 Apr 2014 14:48:09 +0530 Actos Tablets had annual US sales of US $236 million. Lupin's Pioglitazone Tablets USP, 15 mg, 30 mg, and 45 mg are the AB-rated generic equivalents of Takeda's Actos Tablets 15 mg, 30 mg, and 45 mg and is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus in multiple clinical settings. ]]> <![CDATA[High burden of rotavirus in Bangladesh]]> https://biospectrumindia.com/reports-white-papers/95/4264/high-burden-of-rotavirus-in-bangladesh.html https://biospectrumindia.com/reports-white-papers/95/4264/high-burden-of-rotavirus-in-bangladesh.html Fri, 11 Apr 2014 14:42:00 +0530 Findings from hospital-based surveillance conducted by The International Centre for Diarrhoeal Disease Research, Dhaka, Bangladesh, (icddr,b), between July 2012 - January 2014 show that 67 percent of children below five years of age hospitalised for diarrhoea in seven hospitals in Bangladesh had rotavirus. These surveillance data provide invaluable evidence to the Government of Bangladesh on the prevalence of rotavirus in the country and can help contribute to its plans to include a rotavirus vaccine in the country's immunization programme to reduce hospitalizations and deaths due to the virus. The World Health Organization (WHO) has recommended that a rotavirus vaccine be included in all national immunization programmes, but many countries especially low and middle-income countries have not done so. In order to collect relevant data on mortality and morbidity due to rotavirus diarrhoea in the country, icddr,b's Centre for Communicable Diseases (CCD) in collaboration with Institute of Epidemiology, Disease Control and Research (IEDCR), the US Centres for Disease Control & Prevention and USAID, started the Hospital Based Rotavirus & Intussusception Surveillance (HIBRIS) in seven hospitals (3 government and 4 private tertiary hospitals) in seven divisions of Bangladesh. The results of the two year surveillance also revealed that 77 percent of children infected with rotavirus were between 6 and17 months of age, and the peaks of infection were between the months of November and February. Genotypes of isolates consisted of four G types (G1, G2, G9, G12) and three P (P4,P6,P8) types. The most prevalent G and P type combinations were G12P[8] (33 percent) and G1P[8] (25 percent). Over 52 percent of the isolated strains of the virus were found to be preventable by introducing two currently licensed rotavirus vaccines. Thirty nine children below two years were identified with confirmed intussusceptions - two of the children died. Most of the children with intussusception were between 6 and 11 months of age (62 percent) and most were male (77 percent). Based on the HIBRIS findings, Dr Emily Gurley, acting director, CCD and principal investigator of the surveillance project, urged the government to prioritize the introduction of the rotavirus vaccine in the national Expanded Program for Immunization. The findings were shared at a seminar organised by icddr,b with IEDCR on 6th March. At the seminar, the Secretary of the Ministry of Health and Family Welfare Mr M Neazuddin emphasized the importance of collaboration with non-governmental organizations (NGOs) saying that, "It is the government and NGO collaborative actions that have led to different successes in our health sector and has aided in disseminating knowledge of diseases such as those caused by rotavirus." ]]> <![CDATA["Regulations are cause of unease in industry" ]]> https://biospectrumindia.com/news/95/3745/regulations-are-cause-of-unease-in-industry-.html https://biospectrumindia.com/news/95/3745/regulations-are-cause-of-unease-in-industry-.html Fri, 11 Apr 2014 11:01:00 +0530 "From a regulatory stand point, there has been a fair amount of unease in the the life sciences sector in India. The Foreign Direct Investments (FDI) debate which has been under discussion for the last many months will need to be addressed. There are a few issues that surround the current status of the FDI policy in India, for instance," says Mr Utkarsh Palnitkar, partner and national head - advisory, national head of life sciences practice, KPMG India. When asked about his expectations from the next government, Mr Palnitkar said, "The criteria for approval of brownfield investments must be very clearly articulated. The removal of the non-compete clause poses a threat to companies wishing to operate in niche areas." "The Biotechnology Regulatory Authority of India (BRAI) Bill has been under discussion for about two years now. The bill was designed to promote biotechnology in the country by setting up an autonomous and statutory body to regulate the research, transport, import, manufacture and use of organisms and products of modern bio-technology. As in the case of FDI, the next government will have to make some clear decisions in this context too, mentioned Mr Palnitkar on the key biotech bill pending in the parliament. Talking about the clinical trials, Mr Palnitkar remarked, "The clinical trials industry in India has undergone a lot of stress, given the long drawn process and uncertainty surrounding regulations that has stalled a number of trials in India. A balance between the protecting the rights of recruited subjects while providing clear norms for the conduct of trials is the dire need of the hour." "At the core of the issue lies the lack of regulations which are stable and do not undergo changes time and again. The requirement of dealing with multiple regulatory authorities both at the central and state level adds to the complexity of doing business," Palnitkar said. ]]> <![CDATA[Wockhardt Foundation organizes health camp ]]> https://biospectrumindia.com/news/95/3755/wockhardt-foundation-organizes-health-camp-.html https://biospectrumindia.com/news/95/3755/wockhardt-foundation-organizes-health-camp-.html Thu, 10 Apr 2014 16:18:24 +0530 About 400 people from the RCF slums benefitted from the camp led by Dr Akshay Chhallani , Senior General Physician, Wockhardt Hospitals. The occasion was graced by Mr Joi Barua, lead vocalist of the band 'Joi' and the National Film award winner movie 'Dev D'. Almost every fourth house in Mumbai slums has a family member who suffers from some vector-borne diseases. Morbidity and Mortality in urban slums due to vector-borne diseases, infections and inferior sanitary conditions is quite common. According to a study, water borne morbidity in Mumbai slums was 24%. In this light, Dr Huzaifa Khorakiwala, trustee and CEO, Wockhardt Foundation said, "Wockhardt Foundation has been committed to improving the health and sanitation situation among the slums in Mumbai. Some of the key related initiatives by Wockhardt Foundation are Mobile 1000 program for providing primary healthcare services to the poor, Dr Health program for awareness on health, illness and cleanliness, Shudhu for free distribution of water purification tablets and Bio-Toilets for complete waste management solution. Dr Akshay Chhallani , senior general physician, Wockhardt Hospitals expressed, "Practicing proper health, hygiene and sanitation is mandatory to prevent infections and vector-borne diseases. Incidences of Malaria, dengue and chikungunya are due to unhygienic surroundings and consumption of impure water. Open defecation causes various health hazardous. Maintaining sanitation around toilets is critical to prevent breeding of mosquitoes responsible for causing vector-borne diseases. Water is the breeding place for vectors such as dengue, malaria mosquitoes. Consumption of impure water leads to infections and morbid conditions. It is therefore important to consume pure drinking water." Ms Shreyata Sohni, water purification expert from Wockhardt Foundation demonstrated the use of Shudhu tablets for water purification and better sanitation. More than 200 Shudhu strips (1 strip per person) were distributed free of cost among the slum families. A group of youngsters from the 'Yash Theatre Group', Ghatkopar performed a street play for slum dwellers on 'Health and Sanitation measures to prevent vector-borne diseases'. Marathi and Hindi pamphlets on vector-borne disease awareness and Shudhu water purification instructions were distributed. ]]> <![CDATA[Nova Medical Centers honored]]> https://biospectrumindia.com/news/95/4034/nova-medical-centers-honored.html https://biospectrumindia.com/news/95/4034/nova-medical-centers-honored.html Thu, 10 Apr 2014 16:00:00 +0530 The Awards felicitate India's most innovative mid-sized companies that demonstrate the agility, responsiveness and skill to engineer smart solutions to unique problems. Nova won basis excellence in the four parameters of Uniqueness, Replicability, Scalability and Business Metrics. Accepting the award at the ceremony, VP Kamath, group chief operating Officer, Nova Medical Centers, said, "I consider it a great privilege and honor to receive this award on behalf of Nova Medical Centers. I think this Award sends a very strong message that Indian companies can come up with fresh and creative approaches to healthcare problems in a tough economy, and craft successes that aren't just profitable, but also serve as a case study for others." A total of 300 companies were considered for the Innovative100 Awards by the Inc. magazine. The final set of 100 winners was selected after a four-month-long nomination and evaluation campaign. The seven-member jury included prominent investors, corporate professionals and serial entrepreneurs. ]]> <![CDATA[Seaweeding unchartered territories]]> https://biospectrumindia.com/features/95/3888/seaweeding-unchartered-territories.html https://biospectrumindia.com/features/95/3888/seaweeding-unchartered-territories.html Thu, 10 Apr 2014 15:26:32 +0530 In 2007, he stepped down as the president of R&D at Biocon to become an academician at IIT-Madras. Now, with a vision to farm the seaweeds to meet growing commercial energy demands, he serves as the chairman of Sea6 Energy. The company believes that there is an urgent requirement to replace the traditional fossil fuels with a more environmentally friendly alternative. To achieve this, scientists at Sea6 energy are trying to convert photosynthetic biomass including plants, grasses and algae in to fuels. He left his job at Biocon in 2008 and started teaching at IIT-Madras when a handful of students there sought his help to enter the esteemed iGEM competition at the Massachusetts Institute of Technology (MIT) in the United States. Unfortunately, the students were denied the visas but still managed to win a prize after demonstrating their idea through a video presentation. After this victory, Dr Suryanarayanan and the team of students began to sharply focus on biofuels. Consequently, the team attended algal biofuel conferences. Finally in 2010, seaweed became the center of everybody's thought processes, in their endeavor to discover an alternative source of fuel. The company was started through investments made by Dr Suryanarayan himself, and as well as contributions from IIT-ians at Madras, which added up to Rs 1 crore. Dr Suryanarayanan's interest in creating bioenergy sprung way back in the 1982, even before the world began to think on fossil fuel alternatives. After joining Biocon in 1983, Dr Suryanarayanan proved to be an exceptional scientist. He met Dr Kiran Mazumdar-Shaw while he was pursuing his chemical engineering at IIT-Madras. She and Dr Suryanarayanan shared a common dream to create revolutionary innovation in biotechnology. Once graduated, he was persuaded by Dr Kiran to join Biocon in its R&D endeavors. Dr Suryanarayanan is known for his unrelenting leadership at Biocon's innovation-led enzyme business. Dr Suryanarayanan feels that seaweeds have major advantages since it has the potential to become the futuristic biofuel, and growing them requires shallow ocean waters and direct nutrients. So far about three labs are working on macro-algal biofuel including Bio Architecture Labs, the Korean Institute of Industrial Technology and the Philippines government. India imports about two-thirds of its crude oil at the moment. In the face of diminishing fossil fuels, their detrimental effects on the environment and phenomenal price rise, the company feels that converting photosynthetic biomass into fuels is the safe way in creating a sustainable future for the next generation. The innovative minds at Sea6 Energy sees a future where the vast oceans will become earth's biofuel farm house. Cultivation of seaweed is not a new technology in our society. Seaweed cultivation has been around for centuries all across the world for varied commercial purposes. The strategic geographical location of Indian sub-continent allows it to receive rich and plentiful sunlight for plants. India has special access to vast stretches of ocean which gives it an added advantage of cultivating seaweeds at enormous scale thereby creating economic benefits. Seaweeds were primarily a part of popular diet. However, seaweed cultivation is a laborious process and the seaweed cultivation process has remain unchanged even till this day. The team today firstly are focusing on geographical constraints of shallow and calm seas which are indispensable for traditional seaweed farming. Also, to aid the cultivation, Sea6 Energy has come up with innovative and proprietary structures for creation of low-cost seaweed farms on the surface of the sea. These structures would facilitate cultivation of seaweeds in turbulent waters, thus opening avenues for vast sea stretches along the coastlines for cultivators. This altogether seem to generate massive employment opportunities for the rural population and fishing communicates along the coastal areas and sea shores. Furthermore, Sea6 Energy is also engaged in activities to make the laborious seaweed cultivation in to a more lighter and efficient one. This will enable cultivators to be highly productive in the cumbersome process of trying to convert seaweed farming activity from a labor intensive process into an efficient one. Seaweed biomass have been identified to be rich in carbohydrates which can be converted in to sugars. These sugars can further be converted into alcohol and fuel through advanced techniques in biotechnology. However, the challenge is that the chemical composition of seaweeds significantly differ from that of terrestrial plants. This needs to be tackled through developing new ways in biotechnology which can convert these carb-rich seaweeds in to sugars and then in to fuel. The company is also relentlessly working on practical applications in reducing the use of fresh water for seaweed cultivation. By amalgamating various proven techniques and making them fit in to the larger jig-saw biotechnology puzzle, Sea6energy firmly believes that biofuels from seaweed can be a viable eco-friendly option for traditional liquid fossil fuels. ]]> <![CDATA['Time-tested advice of network is net worth']]> https://biospectrumindia.com/features/95/3474/time-tested-advice-of-network-is-net-worth.html https://biospectrumindia.com/features/95/3474/time-tested-advice-of-network-is-net-worth.html Thu, 10 Apr 2014 14:38:05 +0530 For two years, QTLomics was incubated at Genotypic Technology, a 15-year-old Genomics services enterprise, offering microarray, Next Generation Sequencing (NGS) and bioinformatics services and solutions.The backgroundWith an ever increasing Indian population number, 70 percent of them depend on agriculture for their livelihood. "With our booming economy and urbanization, Indian population seems to be growing day-by-day. There is a massive change in our diet style. On the other hand, we are witnessing huge biodiversity loss, along with acute water scarcity, and in a few years from now the water table that we see today will disappear. On top of that, there is the issue of climate change, leading to sudden changes in the earth's temperature and atmosphere as a result of messed up ozone layer," explains Dr Krishna Prasad, COO, QTLomics, talking about the company's background. "Earlier we had four months of rainy season which now has reduced to a month or two. All these factors are worrying our farmers way too much." Dr Prasad continues, "Thus, we now need to produce more and more food, for which seed is pivotal. Now, the challenge is, farmers need to grow more food in the same space of land. Hence the seed varieties need to be changed." He further elucidates, "Hence, we felt that there is a big challenge and we decided to use technology to bring about the change by focusing on agriculture. This idea started and was incubated two years ago within Genotypic Technology. In December 2013, we decided to move this arm out as a separate subsidiary company focusing on agriculture." The name 'QTLomics' is a portmanteau word, derived from the words 'Quantitative Trait Locus' and 'Genomics', currently having 6 employees including scientists, marketing & sales personnel and financial experts. Service offeringsGenomics essentially uses technology concerned with gene and protein, which involves biology, engineering and statistics. "We would like to support plant breeders. Using Genomics, we will help plant breeders, identify markers or genes responsible for a particular trait. The main purpose it to bring right plant variety having desirable characters. We are taking this technology and seeking to apply it in a novel way," adds Dr Raja. The challenges According to Dr Raja, the biggest challenge for a start-up is finding the entry in to the market. "QTLomics was initially incubated at Genotypic Technology during which we studied the market. The answers were found during the incubation period," says Dr Raja. Approximately, Rs 3 crore was invested in bringing QTLomics to the market with a two- year incubation time. "We raised our funds through friends and angel investors without any hassle, rather than running to venture capitalists. So our real challenge has been postponed for now. One year down the line our major challenge will be raising the capital to convert our R&D in to products. The idea is first you put your own money and associate with companies and then ask your friends to aid you further," comments Dr Raja. Right now the company aims to use all its profits in R&D and developing products. According to Dr Raja, in India, applying the modern technology (Genomics) is not a trend among the Indian breeding companies as they are used to traditional breeding practices. He opines, "To have specific budgets for applying Genomics is a challenge. Traditional breeding companies do not have budgets for applying Genomics. A prior example has not been set so far in this regard. This is a worldwide trend among breeders." In India, there is no regulation required to sell seeds. "In our country, you don't need certification for hybrid seeds. This is our biggest challenge as well. The time has come now for the government to certify seeds. Almost 90% of agriculture is done traditionally using normal seeds. Under these circumstances, we help people to self-certify or we certify the seeds. Certified seeds can be sold for higher price, which is an added advantage," explains Dr Raja. The AwarenessSpeaking about raising awareness on agri-genomics, Dr Raja gladly says, "We are running workshops, roadshows, attending conferences and also delivering lectures and presentations in breeding conferences and national seed congress. We are going to collaborate with leading scientists in the academia. We run one of the world's largest LinkedIn group in Agriculture Genomics with over 4000 users, and the users are located all over the world. This LinkedIn group was started 3 years ago and this is one of the major ways through which we spread the news of how to apply Genomics in plant breeding." The collaborationsRight now the company has collaborated with DYN Diagnostics in Israel, who are experts in marker-assisted breeding (MAB). It also aims to pitch genomic-assisted breeding to the seed companies. Dr Raja also states, "Currently we are doing tests on commercial hybrids in India. We are collecting tomatoes from the markets genotyping them to see the trait of each tomato. I believe this is going to make a big news in the market as no such study has been carried out before." "We are now targeting Singapore and the Asian markets since breeding is climate dependent because the plants that we are growing is different from what is grown in Europe. In terms of revenues, we will make USD 1 million in the first year, and all the profits will be used purely for our R&D purposes," reemphasizes Dr Raja. The clienteleTalking about the clients, Dr Raja adds, "Firstly, with MNC companies having breeding stations in India who are already applying Genomics and marker-assisted breeding. They have issues sending samples out of India. We are working with them to provide the services. Secondly, we want to work with large Indian seed companies like Nuziveedu Seeds, Kaveri Seeds, Mahyco, and Rasi Seeds, who are probably going to apply Genomics in agriculture. Thirdly, we want to associate with mid-sized Indian companies and importers and exporters of seeds. India is a major importer of seeds. If companies want to breed the seeds, then we would be the right people. "One thing we are clear about is that we are not going to create and develop GMOs using recombinant DNA technology," says Dr Raja, brimming with confidence. Further expansionDr Raja optimistically opines that in the next one year, the company will have its own green house, farm house and tissue culture facility, and a plant molecular biology lab to provide end-to-end services. "We also welcome companies outside India, should they need our services. They can send in their samples to us. We also want to capture markets in Malaysia, Thailand and South Africa, where agriculture is important and the ecosystem is quite messed up," expresses Dr Raja. Innovation Speaking about innovation at QTLomics, Dr Raja adds, "Once we understand the problem, the next phase would be to plan about how to get around it. It doesn't necessarily imply the application of high-end technology. We need to look at available technology and see how best we can apply them with the least amount of money to create a solution in an innovative way." He continues, "We have scientific members from agricultural universities and plant breeders. We would like to involve everybody and discuss challenges and how to deal with it. Social media and publications give tremendous visibility to the company." The governmentDr Raja says that he is very content with the Karnataka government's initiatives and plans. "People should not complain about government not doing anything. They have made life much easier. You have to figure out how to take advantage of their offerings. And do not expect to be spoon-fed. Find what the government has to offer with respect to R&D funds and R&D products, and make use of all of it," reveals Dr Raja. For young entrepreneursFor a start-up, the first two years are critical. "Doing the basic groundwork and carrying out essential homework is indispensable. The time-tested advice of your network is your net worth. You got to be very strong in you professional social media circles. In our case, we started our presence in the professional social media circles even before we even had our website," exclaims Dr Raja. He further elaborately advises, "Do not ever think that you can start and then raise funds. If you don't have funds, then don't even start. Entrepreneurship is rebellion against establishment. When you rebel, you need to fight hard with your weapons (capital). Ensure many of the little things are taken care by professionals like registering the company, taxation or even starting a bank account. Gone are the days where entrepreneurs got to do everything, so do not even bother learning certain things. Focus on something which you have to learn like the basics of accounting, finances and management. Maybe you can learn it through professional courses, friends and consultants the hard way. Take your 'gurus' help to learn than from your mistakes, because in the current world, time is money." Talking from his own experience and mentoring, Dr Raja says, "For first-generation entrepreneurs, getting a loan from the banks is a mammoth challenge. Pooling in money from other sources is crucial. The market too poses a major challenge." Dr Raja concludes saying, "Once you find your space and place, you run your business with ethical principles. Stop cribbing about what is not available in the system. Don't waste your energy breaking through barriers. Just go around them. On any given moment, every day we hear about the gloomy economy and unavailability of funds. These are entry-level barriers and are part of the rules of the game. You have to work with it rather than challenge it." ]]> <![CDATA[Aiming indigenous affordable biologics for all ]]> https://biospectrumindia.com/news/95/6401/aiming-indigenous-affordable-biologics-for-all-.html https://biospectrumindia.com/news/95/6401/aiming-indigenous-affordable-biologics-for-all-.html Thu, 10 Apr 2014 14:01:00 +0530 Tergene Biotech was founded by Dr Mosuvan Kuppusamy, a biotechnologist well known in the vaccine industry with three decades of experience in research and manufacturing of biologics. Having been associated earlier with the various prominent companies, Dr Kupusamy wanted to follow his heart and finally decided to start his own venture. The company started its research and development (R&D) activities in the year 2010 by acquiring lab space in Biotechnology Incubation Centre, Hyderabad. The initial recognition came when its in-house R&D centre was recognised by the Department of Scientific and Industrial Research (DSIR) in 2011. The main research focus was in developing affordable vaccines against infectious diseases based on the polysaccharide-carrier protein conjugate platform. Besides vaccines against infectious diseases, Tergene is working on the development of therapeutic vaccines against antibiotic resistance, cancer and allergy. Tergene is developing bio-conjugate platform technologies for novel vaccines and antibody drug conjugates. It has developed the multivalent Pneumococcal Conjugate Vaccine (PCV- 15) employing an innovative micro reactor based conjugation chemistry. Initial funding support for the PCV-15 project was received from BIRAC and the company successfully established the proof of concept, eventual scale-up and validation of the process. In recognition of this achievement, Tergene was awarded with Biotechnology Industry Research Assistance Council (BIRAC) Innovators Award-2013 in the Healthcare sector.The award is in recognition of the company's significant contribution to innovative research towards the "Development of an Indigenous India specific 15 valent Pneumococcal Conjugate Vaccine". The company deeply acknowledges the Biotechnology Industry Partnership Program (BIPP) from BIRAC for the financial support and hand holding in the successful completion of the innovative technology platform. This award boosts up the company's morale and encourages in pursuing the next stage of clinical validation and early commercialization of the vaccine. The PCV-15 vaccine is awaiting preclinical and clinical evaluation. Another significant achievement of the company is the development of a cost effective production technology for CRM-197, the safest carrier protein and a key ingredient in the development of PCV-15. It also finds application in other therapeutic vaccines against cancer and allergy. Tergene offers its partners a full range of services from bioprocess development to manufacturing to approval of the finished product. A basket of vaccines against bacterial pneumonia is under various stages of development. Vaccines currently under advanced stage of development include a multivalent pneumococcal vaccine and Meningococcal vaccine. Tergene also had the options to develop a Haemophilius influenzae B conjugate vaccine and acellular pertussis vaccine directed to prevent the main causative bacterial agents of pneumonia, but is presently focused on the pneumococcal polysaccharide conjugate vaccine. The company is setting up a manufacturing facility (as per Good Manufacturing Practices norms) near Chennai, Tamil Nadu. The state-of-the-art facility will be operational by the end of 2014 and will be used to manufacture vaccines, biopharmaceuticals and probiotics. This will give Tergene a manufacturing facility matching the specifications of the US Food and Drug Administration. The suite will have up to 1000 L of fermentation capacity besides state of the art down stream equipments and purifications systems. The suite will have the necessary support areas such as formulation and fill-finish facility for liquid and lyophilized vials. All bio waste generated in the process will be thermally inactivated prior to treatment. According to Dr M Kuppusamy, "The present ecosystem is good enough for ignition and proof of concept stages but the real challenge for start ups is in mobilising funds for Pre-clinical and Clinical evaluations. Uncertainty and delay in regulatory approvals for preclinical and clinical evaluation is of great concern for us." Mentioning that collaboration is crucial during initial phase, Dr Kuppusamy added,"A public private partnership is a real opportunity for start-ups promoted by scientists with technology as the prime investment. Hence, we appreciate the timely help from the department of biotechnology (DBT)." On being asked about the product among the basket that looks most appealing, Dr Kuppusamy elaborated,"The CRM-197 is a critical game-changer in the development of affordable conjugate vaccines. The company has already started supply of GLP grade CRM-197 to research institutions at competitive price. The company is in the process of building a GMP compliant manufacturing facility for CRM-197 with an annual capacity of 10 kg." ]]> <![CDATA['Identifying committed core team crucial']]> https://biospectrumindia.com/features/95/5660/identifying-committed-core-team-crucial.html https://biospectrumindia.com/features/95/5660/identifying-committed-core-team-crucial.html Wed, 09 Apr 2014 15:34:51 +0530 Prior to this, Ms Kavitha and Mr Sohang had jointly cofounded the biotech start-up Inbiopro in 2007, which was acquired by Strides Arcolab in 2010. A new beginning"After we exited Strides as founders of Inbiopro in 2012," comments Mr Sohang, "we realized that our own biotech journey was incomplete. We wanted to see our products reach the end-users, and do a lot more than churn out me-too products. Hence we decided to focus on R&D platforms that can lead us to biobetters and ultimately in to new therapeutic drugs." "Since the cost of taking a biobetter to market is much higher than biosimilars and competes with the innovators' products, we had to think global, by partnering with large multinationals with established presence in the regulated market as well," he adds. Investments and capitalDuring Theramyt's inception, the founders invested personal capital and raised a Series A for Rs 27.6 crore from venture capitalists including Accel Partners, IDG Ventures, Aarin Capital and KITVEN (Karnataka Information Technology Venture Capital Fund). With over $100 billion worth of biologics going off-patent by 2020, the biosimilar market is estimated to be at least $12 billion by then. While biosimilars would account for growth, it would mostly be a cost-driven market. According to Ms Kavitha and Mr Sohang, it is important to differentiate beyond cost. Improving on existing products as well as developing better products with continuous innovations in technology is the key to Theramyt becoming a game-changer. Equipped with previous partnership experiences, and having a strong network with the biopharmaceutical companies that are developing biologics in the regulated markets in the US, EU, Australia and Japan, the founders recognized the obvious progression of the biopharmaceutical industry while establishing Theramyt Novobiologics last year. "Our business module is fundamentally divided in to biosimilars and in-house R&D platforms that can convert these biosimilars to biobetters or new biological entities. We are working on platforms that will improve existing biologics either through efficacy or through formulations and alternative delivery systems. And all products would be developed in our proprietary expression systems. In the meanwhile, we are partnering with biosimilar players to develop and license out biosimilars of their interest. But we are not a CRO," elaborated Ms Kavitha. Initial challengesSpeaking on the many challenges faced while establishing the new start-up, Ms Iyer Rodrigues commented, "The process for securing funding took longer than envisaged, mainly due to the confusion arising from the suspended pharma policy on foreign investment. However, the VCs showed a lot of faith in our team and in our business model. So they patiently supported us through the approval and legal process." "Secondly," she continues, "getting certifications from the Pollution Control Board (PCB) was another challenge. The whole process took a while and we had to realign our timeline and budget based on their delayed approval. Thirdly, the unclear regulatory environment is a challenge. But I am sure this is a process and as the industry matures, we can all together figure out what is best for the industry and ultimately what benefits the people." The teamTheramyt's core team, comprising Dr Maloy Ghosh, heading the R&D as CSO, Dr Sunit Maity, heading product development as VP and Mr Anirban Bhattacharya, CFO and CS, was already in place before the company approached VCs for funding. The core team formulated the company's strategy through many rounds of discussion with various advisors. The company's focus on disease areas is driven by application of their technologies and covers anti-cancer followed by rheumatoid arthritis, metabolic diseases and cardio-vascular diseases (CVD). Theramyt's R&D platforms are a combination of science and technology with a clear final goal of productization. "Most of the scientists and engineers in our team have prior experience in niche R&D companies and hold a number of patents. Many of them have doctoral and post-doctoral qualification. Unlike our previous organization, this time we are IP driven," adds Ms Iyer Rodrigues. For the next 18 months, according to Mr Sohang, the company will primarily focus on building R&D platforms, and not seek any commercial collaboration. For biotech entrepreneursFor young biotech entrepreneurs, Mr Sohang advises, "While building a company, it is important to identify a committed core team that covers the various aspects of business. This must be supported and supplemented by a strong advisory board. At Theramyt, we have shared equity with all members of our core team as well as with our scientific advisors. Further, we already have a detailed ESOP policy for high performing individuals in the organization." "Biotechnology burns huge capital for all its R&D and has a much longer incubation phase than classical pharma or most other start-ups. Not only the founders but also the investors need to have a deep understanding of the capital requirement and develop strict financial discipline in to the operations," emphasized Ms Kavitha. She further adds, "Today, it is easier for youngsters to get in to IT and biospace since the ecosystem is a lot more favorable. We have more incubation centers in the country and the government has invested a lot in to it. Currently, the government's provision through various investments is quite appreciable. DBT's various programs like BIG, SBIRI and BIPP, professionally run by BIRAC, are really encouraging not just the biotechnology ecosystem, but also innovation. At the same time there are some counter-productive clauses from organizations like DSIR on benefiting from certain exemptions that a startup needs. It is important for the various departments of the government to get on the same page and evaluate what is best for the industry." Public-private partnership works!When asked about public-private partnerships, Ms Kavitha optimistically adds, "The Biotechnology Industry Partnership Programme (BIPP) has been a big success. It is a great way to fund innovation and research for companies like us. We'll be accessing grants through BIPP. We intend to work with various academic institutions like IIT, NII, & NCL, and leverage some of the expertise they already possess." The futureAccording to Ms Iyer Rodrigues, Theramyt's technical team is going to be around 35 people for the next two years and scale up to about 50 in four years' time. They are currently 23 in number. "Our current infrastructure measuring 16,000 sq ft and in the process of GLP certification, should be adequate for the next 5 years. We are on the right track to reach our first set of milestones by the end of 2014," says Ms Kavitha. "We want to develop IP from our technology platforms and generate strong proof of concept data before we approach potential collaborators. We also have a defined list of products that we want to develop in to late stage and look for marketing partners for various geographies," summarized Mr Sohang, who currently coordinates all the business development activities. Although a start-up, both the founders are acutely aware of the need for all-round development of the organization, and have invested in an extensive human resource development as well as organization development program with various partners. Both concur that combining empowerment with a collaborative work culture can make Theramyt in to a high performing organization driven by clearly articulated purpose and core values. The company's name was coined by its scientific advisory board, which is a portmanteau of the words, 'therapeutic' and 'might'. ]]> <![CDATA['Start-ups services should meet customers' needs']]> https://biospectrumindia.com/features/95/5906/start-ups-services-should-meet-customers-needs.html https://biospectrumindia.com/features/95/5906/start-ups-services-should-meet-customers-needs.html Wed, 09 Apr 2014 14:46:00 +0530 The humble beginnings SciGenom is a Genomics company, also based in Cochin, which explores and exploits the advances in Genomic technologies to bring new services and products for life science industry. Mr Sam Santhosh, the founder of SciGenom and MedGenome has been an entrepreneur, with over 20 years' experience in the software industry. Currently he is also the CEO and chairman of SciGenom Labs. Prior to this, Mr Sam was the CEO and MD of California Software Limited (Calsoft) between 1992-2012. "The completion of the first draft of the Human Genome and the explosive growth of sequencing technologies attracted him to start SciGenom and MedGenome," says Dr V L Ramprasad, COO and principal scientist, MedGenome Labs. The servicesMedGenome provides molecular genetic diagnostics using Sanger Sequencing & Next Generation Sequencing (NGS) technologies for personalized healthcare. "The major services offered by SciGenom are Next Generation Sequencing and software tools around it. The human genetic testing (diagnostic) services has been incubated as a separate entity, which is MedGenome," adds Dr Ramprasad. "Molecular diagnostic tests can help determine which variations in the patient's genes should be targeted for the right treatment option, especially in cancer," explains Dr Ramprasad. He further goes on saying, "The tests will also aid clinicians in screening to predict the risk of developing a specific disease. We also develop software tools that help clinicians demystify the genomic data so that they take clinical decisions. Apart from the Genetic tests that are targeted at one gene and one disease, we can do Whole Exome sequencing and Whole Genome sequencing, that can sequence hundreds of genes and MedGenome's expertise is in picking the needle in a haystack." The company also soon aims to start exciting molecular tests that will do away with invasive methods like tissue biopsies in cancer patients and amniocentesis in pregnant women. The challenges"The main challenge was in getting the medical market to understand the value of genetic tests. "Secondly, developing low-cost tests and a strong bioinformatics team was the next challenge. The high customs duty on the raw materials currently still remains a challenge," voiced Dr Ramprasad. The funding and setbacksInitially, Mr Sam Santhosh was the sole investor while establishing the company. "Now MedGenome has raised USD $5 million through Emerge Ventures, a venture capital company based in Singapore," he adds. Currently, the company caters to academic translational research centers, tertiary hospitals, specialty clinics, oncologists and pharma companies. "Being incubated at SciGenom," he says, "we did not have face serious issues like other start-ups. The main challenge was getting the right people with the requisite skills." For young entrepreneurs who want to set foot in the start-ups circle, Dr Ramprasad advises, "Any start-up needs to ensure that its services and products meet customers' needs genuinely by providing real value. Then you need to ensure that the company has sufficient funding and a well-qualified management team." Expansion strategyTalking about MedGenome's expansion plans, Dr Ramprasad adds, "We are buoyed by the extremely positive response that we are getting from the industry and market for our service offerings. We are putting additional resources to scale up the operations. Starting a state-of-the-art lab in Bangalore which will soon become the hub of MedGenome operations." MedGenome's also plans to start satellite labs across the country to expand its services. "The bioinformatics tools and services that we are planning are going to be the key for our success," he says. The workforceThe company now has 8 experienced PhD scientists who run day-to-day operations with separate teams. "We also have exclusive scientists who develop new affordable tests, and two medical doctors who help in clinical affairs," says Dr Ramaprasad. He also further states, "Our small but well experienced research team based in the US work on developing niche tools and tests for Indian market. The most important is the strong bioinformatics and software development team, who efficiently make the ATCG data into meaningful conclusions." Dr Ramprasad also credits his marketing team who bring the much needed revenue for the company. "Now our overall staff strength currently is 40. And this is expected to grow to about 60 this year," he mentions. The collaborationsDr Ramprasad feels that the government should ensure the right ecosystem and infrastructure is available for start-ups. "Which includes incubator facilities, low cost funding, and tax incentives and so on," he comments. When asked about the company's collaborations, Dr Ramprasad opines, "We are collaborating with key hospitals and translational research centers in India like Tata Memorial Hospital in Mumbai, Madras Diabetes Research Foundation in Chennai, and Narayana Nethralaya in Bangalore to name a few." The company plans to make use of different schemes promoted by the Government through DBT. The futureAccording to Dr Ramprasad, the company is targeting to develop a low-cost yet highly accurate genetic test for average Indian patients. "We are optimistic to reach this goal in the next one year," he expresses delightfully. Currently, the company is establishing its state-of-the-art genetic testing laboratory in Bangalore, which is a sequencing-based, non-invasive, prenatal testing lab for the first time in the country. He continues, "We are also developing a path-breaking somatic mutation software that helps clinicians guide treatment modalities." "In the next two years, we aim to be one of the best genetic testing services company in this part of the world," concludes Dr Ramprasad. ]]> <![CDATA[ABLE-AG feels positive about BJP manifesto ]]> https://biospectrumindia.com/news/95/5440/able-ag-feels-positive-about-bjp-manifesto-.html https://biospectrumindia.com/news/95/5440/able-ag-feels-positive-about-bjp-manifesto-.html Wed, 09 Apr 2014 09:41:00 +0530 When asked about his response on the BJP manifesto that was released on April 08, 2014, Dr Seetharama Nadoor, executive director, Association of Biotechnology Led Enterprises- Agriculture Group (ABLE-AG) expressed his positive reaction. He mentioned,"We welcome the stance of BJP on the issue which seems to be in alignment with the national consensus on the issue. Infact, the present goverment too has had been maintaining the same position. The evaluation of new technology and regulatory evolution is a part of unanimity on the issue. It is good that they have mentioned this. We hope that the Biotechnology Regulatory Authority of India (BRAI) bill would be brought back by the next government." Dr Nadoor went on to say that the manifesto has mentioned the incorporation of new technologies to boost agriculture and it cannot be taken as a plain refusal to the GM crops. "It is just a part of national strategy to ensure proper regulations which we can understand. The views too have been evolving," said Dr Nadoor. ABLE-AG aims to accelerate the pace of agricultural growth in India by enabling strategic alliances between researchers, the government and the global biotech industry to increase crop productivity, help meet domestic food security, and contribute to inclusive growth. ]]> <![CDATA[Novartis' new injection counters tremors among MS patients]]> https://biospectrumindia.com/news/95/7688/novartis-new-injection-counters-tremors-among-ms-patients.html https://biospectrumindia.com/news/95/7688/novartis-new-injection-counters-tremors-among-ms-patients.html Tue, 08 Apr 2014 15:54:26 +0530 More than 500 multiple sclerosis (MS) patients and healthcare professionals in the US, the UK and mainland Europe were involved in the development process to ensure the device was underpinned by a deep understanding of the users. An estimated 2.5 million people worldwide have MS, a disease affecting the central nervous system. "Our aim was to make the ExtaviPro 30G auto-injector very simple and intuitive to use, and enable one-handed injection," said Mr Andy Pidgeon, head, industrial design and human factors group, Cambridge Consultants. "Its ergonomic shape leads patients to instinctively hold it correctly - which is vital for those who suffer from tremors, as having a firm grip is key to self-injecting safely." The ExtaviPro 30G is aimed at people who suffer from relapsing forms of MS - such as clinically isolated syndrome (CIS), relapsing-remitting MS (RRMS) and secondary-progressive MS (SPMS) - who make up the majority of MS patients. He further added, "Another key factor was the feedback we received during our extensive user research. Patients wanted a soft, non-threatening design, for example, so we've made it very user friendly. And it's led to the creation of a drug delivery device that doesn't look like a badge of infirmity." ]]> <![CDATA[Piramal Enterprises' Pharma Solution division lauded for quality and reliability]]> https://biospectrumindia.com/news/95/3756/piramal-enterprises-pharma-solution-division-lauded-for-quality-and-reliability.html https://biospectrumindia.com/news/95/3756/piramal-enterprises-pharma-solution-division-lauded-for-quality-and-reliability.html Tue, 08 Apr 2014 11:59:53 +0530 Piramal Enterprises' Pharma Solutions Division, a global pharmaceutical contract development and manufacturing organization (CDMO), has received CMO Leadership Awards 2013 in two categories - Quality and Reliability, at a prestigious ceremony at DCAT in New York. Within the Reliability category, Piramal has been recognized as the most "Reliable" CMO among the 5 CMO's shortlisted for this award. The CMO Leadership Awards are given by Life Science Leader based on the industry leading research conducted by Nice Insight. They survey over 11,000 buyers of outsourced services annually to determine perception and awareness scores of CMOs for five different attributes (i.e. Innovation, Productivity, Quality, Regulatory, and Reliability). Companies achieving top 20 percentile perception scores across these 5 attributes are recognized for their achievement. The annual award recognizes those contract manufacturing organizations (CMOs) that are the most highly rated by industry respondents. Unlike other industry awards, which are given based on a subjective voting or nomination process, the only votes that count towards the CRO/CMO Leadership Awards are those of the pharmaceutical and biopharmaceutical companies using CRO/CMO services. Mr. Vivek Sharma, ceo - Pharma Solutions & Critical Care Division, Piramal Enterprises Ltd said, "These awards are a representation of our work which all our sites have been implementing for our customers. This recognition is a huge achievement for us and a step forward in our mission to move towards "Customer Centricity". Being Customer Centric is not just about asking what the customer wants, it is about reading signs, pre-empting expectations and going beyond what is an obvious choice." It has a successful performance record of over 40 years for the supply of APIs and Drug Products and Drug Discovery services to the US and European markets from its facilities located in North America, Europe and India. Niche technologies such as Biocatalysis & Advanced Flow Reactors (AFR) are an area of focus to support our customers to develop cost competitive processes. Significant investments in new technologies and capacity expansions have been made recently such as upgrading the US FDA approved Grangemouth, UK, ADC manufacturing facility with an investment of USD 2.5 million. Furthermore, Piramal is investing 11 million USD at its Morpeth, UK facility to triple the production capacity for hormonal products. ]]> <![CDATA[Clinical activities not planned in BGRC: Baxter]]> https://biospectrumindia.com/interviews/95/3757/clinical-activities-not-planned-in-bgrc-baxter.html https://biospectrumindia.com/interviews/95/3757/clinical-activities-not-planned-in-bgrc-baxter.html Tue, 08 Apr 2014 11:29:27 +0530 In this role, he is instrumental in aligning R&D and commercial opportunities to accelerate innovation at Baxter and enhance care for patients globally. Dr Schabacker holds an MD and a Doctorate in anesthesia from Medical University of LÃ¼beck in Germany, and certifications in anesthesiology, disaster medicine and emergency medicine. Excerpts: Q: India has taken a beating in the area of clinical trials. Almost half of the clinical trials in India is halted. In such scenario, why do you think establishing a Baxter Global Research Center (BGRC) in India with Syngene would contribute to your R&D expansion strategy? Dr Schabacker: Many R&D activities are required prior to the need for clinical trials, and Baxter's global research center in India is very focused on these R&D activities. In the short term, clinical activities are not planned in BGRC, though we will continue to stay in tune with government directives for clinical activities in India for long-term consideration. Q: What kind of R&D will be carried at BGRC? Syngene's Baxter-dedicated global research center will conduct product and analytical development of parental nutrition and renal therapy solutions in the Baxter portfolio. As this partnership evolves, we will continue to look for innovative models of product development and support that meet both global and local needs. Q: What are your expectations from Syngene and vice-versa? The Baxter-Syngene partnership has started off very well, and there is potential to grow and evolve this partnership into more product and scientific areas. We believe there is great availability of world class talent in India, and this talent pool will augment and increase the productivity of Baxter's global R&D. ]]> <![CDATA[â€œCritical policy matters must be dealt immediatelyâ€?]]> https://biospectrumindia.com/news/95/3754/critical-policy-matters-must-be-dealt-immediately.html https://biospectrumindia.com/news/95/3754/critical-policy-matters-must-be-dealt-immediately.html Tue, 08 Apr 2014 10:44:04 +0530 "These policy changes are critical and should not wait for change of government. These matters of national interest, particularly those that require administrative decisions and do not have to wait for legislation should be accorded priority by the government of the day," mentioned Dr Verma when asked about his expectations from the next government. The first issue highlighted by Dr Verma is the need for higher level of financial support to the start-ups and MSMEs, for both pre-clinical and clinical development of biotech especially biopharma products. The funds need to be made available in the form of grants-in-aid to MSMEs. Generally Start-ups have bright ideas that remain buried in the files for the want of funds required for development, particularly clinical trials. Partial funding schemes do not serve the intended purpose. They shore up only cash rich large companies. Withdrawing such partial funding schemes will not do any harm as large companies can pursue their goals without partial funding and MSMEs cannot proceed despite such partial grants-in-aid. To replenish the corpus, the funds may be recovered by the government as royalty on commercialization. This will ensure that investments on early stage developments in the academic labs are not wasted away for the want of requisite funds to take science for societal benefits and would also promote entrepreneurship." Talking about the patents, Dr J N Verma says that these should be granted for significant period of time (years) post-commercialization to ensure returns on R&D investments. "Clinical trials and field trials of biotech and bio-pharma products consume most of patent life, depriving return on investments in R&D and thus discouraging R&D for developing new drugs or products," he said. Dr Verma goes on to mention that the to prevent sub-par "claimed generics and similar", domestic or imported to come to market, non-inferiority trials shall be made mandatory as pre-requisite for marketing approval applications. DBT-CDSCO Guidelines on Similar Biologics: Regulatory Requirements for Marketing Authorization in India under the chairmanship of Dr GN Singh (DCGI) and Dr VP Kamboj (chairman, RCGM and ex-director, CDRI and Honorary Scientist, INSA) states that "--- it is essential that the testing of the similar biologic be sufficient to ensure that the product meets acceptable levels of safety, efficacy and quality to ensure public health." However, Dr Vermafinds it Ironic that despite widely reported slip-ups in the public domains, remedial action is not forthcoming from CDSCO that would restrain sale of products with questionable toxicity and efficacy without ensuring their safety through clinical trials and non-inferiority trials. He says that there should be co-ordination between CDSCO and procurement agencies about the recommended doses of each product approved for marketing. Tenders and rate contracts should clearly invite quotes for daily dose to prevent procurement on the basis of cost of sub-therapeutic doses of sub-par/untested substitutes. It is important in the interest of patients' safety and wastage of precious government funds. Finally, Dr Verma believes that to encourage entrepreneurship, it would immensely help to create insurance schemes in case a young entrepreneur fails in their endeavour. "Such insurance schemes can be created with adequate safeguard to minimise abuse,"concludes Dr Verma. ]]> <![CDATA[BJP favors biofuels, patents]]> https://biospectrumindia.com/news/95/5552/bjp-favors-biofuels-patents.html https://biospectrumindia.com/news/95/5552/bjp-favors-biofuels-patents.html Mon, 07 Apr 2014 16:18:28 +0530 â€œThe party will support large scale use of cleaner fuels to bring down pollution Indian cities,â€? informed the party's Manifesto 2014 released in New Delhi on April, 7, 2014. India is slated to elect a new Parliament in a 9-stage election starting today and the results are expected on May 16, 2014. â€œThe thrust to renewable sources of energy as an important component of India's energy mix will get priority,â€? " BJP's 52-page manifesto has articulated its forward looking actions in many areas relevant to India's $ 2 trillion economy. To boost industrial projects, currently stalled by delayed environment approvals, BJP has promised that â€œenvironment clearances will be transparent and time-bound.â€? It may be noted that the biotech regulator in the environment ministry stalled projects by not meeting at all for more than a year and only sporadically in the last years during the stewardship of Mrs Jayanthi Natarajan of the Congress Party. Promising a bright future in innovation, the BJP has said that â€œwe will embark on a path of generating more intellectual property and patents in a big way.â€? The party has promised to set up world class centers of excellence in nanotechnology, material sciences and brain research. To further promote the use of home-grown technologies, BJP has promised to set up autonomous technology transfer offices in all government laboratories and universities as â€œassociate organizationsâ€? to transfer â€œthe knowhow generated by them to industry.â€? Also, the BJP said, industry will be encouraged to adopt or support educational and research institutions to help direct science and technology endeavors towards tangible industrial goals. In another issue relevant to the bioscience industry, BJP has promised to set up advanced research centers to develop technologies to eradicate tropical diseases prevalent in the country. The Party has also stated that it will encourage and incentivize innovative garbage disposal and waste management practices, especially recycling techniques. ]]> <![CDATA[BJP says NO to GM Foods ]]> https://biospectrumindia.com/news/95/4087/bjp-says-no-to-gm-foods-.html https://biospectrumindia.com/news/95/4087/bjp-says-no-to-gm-foods-.html Mon, 07 Apr 2014 12:46:00 +0530 ]]> <![CDATA[Sun Pharma to acquire Ranbaxy]]> https://biospectrumindia.com/news/95/7491/sun-pharma-to-acquire-ranbaxy.html https://biospectrumindia.com/news/95/7491/sun-pharma-to-acquire-ranbaxy.html Mon, 07 Apr 2014 11:17:00 +0530 Sun Pharmaceutical Industries and Ranbaxy Laboratories have announced that they have entered into definitive agreements pursuant to which Sun Pharma will acquire 100% of Ranbaxy in an all-stock transaction. Under these agreements, Ranbaxy shareholders will receive 0.8 share ofSun Pharma for each share of Ranbaxy. This exchange ratio represents an implied value of 457 rupees for each Ranbaxy share, a premium of 18% to Ranbaxy's 30-day volume-weighted average share price and a premium of 24.3% to Ranbaxy's 60-day volume-weighted average share price, in each case, as of the close of business on April 4, 2014. The combination of Sun Pharma and Ranbaxy creates the fifth-largest specialty generics company in the world and the largest pharmaceutical company in India. The combined entity will have operations in 65 countries, 47 manufacturing facilities across 5 continents, and a significant platform of specialty and generic products marketed globally, including 629 ANDAs. On a pro forma basis, the combined entity's revenues are estimated at US$ 4.2 billion with EBITDA of US$ 1.2 billion for the twelve month period ended December 31, 2013. The transaction value implies a revenue multiple of 2.2 based on 12 months ended December 31, 2013. Mr Dilip Shanghvi, managing director of Sun Pharma said, "Ranbaxy has a significant presence in the Indian pharma market and in the US where it offers a broad portfolio of ANDAs and first-to-file opportunities. In high-growth emerging markets, it provides a strong platform which is highly complementary to Sun Pharma's strengths. We see tremendous growth opportunities and are excited with the prospects to create lasting value for both our shareholders through a successful combination of our franchises." "We believe this transaction brings significant value to all Ranbaxy shareholders. Sun Pharma has a proven track record of creating significant long-term shareholder value and successfully integrating acquisitions into its growing portfolio of assets. We are confident that Sun Pharma is the ideal partner to help us realize our full potential and are excited to participate in future value creation opportunities," stated Mr Arun Sahwney, managing director and chief executive officer of Ranbaxy. The proposed transaction has been unanimously approved by the Boards of Directors of Sun Pharma, Ranbaxy, and Ranbaxy's controlling shareholder, Daiichi Sankyo. Ranbaxy's board and Sun Pharma's board have recommended approval of the transaction to their respective shareholders. ]]> <![CDATA['Indian private investors extremely risk averse']]> https://biospectrumindia.com/features/95/5244/indian-private-investors-extremely-risk-averse.html https://biospectrumindia.com/features/95/5244/indian-private-investors-extremely-risk-averse.html Fri, 04 Apr 2014 18:03:00 +0530 She received her Bachelor's degree from Stanford University and PhD from Rockefeller University. She was a postdoctoral fellow at the Harvard School of Public Health in Infectious diseases. Prior to Vitas, Dr Rangarajan was a scientist in the drug discovery division of Dr Reddy's Laboratories. In her exclusive interview to BioSpectrum's Raj Gunashekar, she emphasizes that, as of now, Vitas' focus will mainly be on infectious diseases. She adds that for an entrepreneur, it is important to have clarity before establishing an enterprise. In the field of new drug discovery for antibiotics, there are only a handful of companies worldwide. Dr Radha quotes this as Vitas Pharma's USP. She observes that in the West, investment in Biotechnology is considered as an essential component of growth. With its operations kick-starting in 2011, Vitas Pharma is a drug discovery and development company, involved in identifying and developing next-generation antibiotics to treat multi-drug resistant hospital acquired infections. The company's management team consists of Dr Radha Rangarajan and Dr Rajinder Kumar, co-founder, serving as the chief medical officer of the company. Drug resistant infections are on the rise all over the world today. "In the United States, 70 percent of the bacteria causing infections in the hospital are resistant to at least one class of antibiotics. In fact, the World Health Organization (WHO) now cites antimicrobial resistance as one of three greatest threats to human health. Given the current levels of drug resistance and their widespread occurrence globally, drugs that overcome resistance and offer significant clinical benefit are urgently needed. This is the focus of theresearch at Vitas Pharma," opines Dr Radha. According to Centre for Disease Control (CDC), multidrug resistant bacteria are responsible for 2 million illnesses, resulting in 23,000 deaths, and costs the healthcare USD 26 billion in the United Statesalone. The Vitas portfolio currently includes compounds for bacterial infections such as hospital acquired pneumonia, complicated urinary tract infections, blood stream infections and complicated skin and soft tissue infections. Adds Dr Radha, "These compounds target vital metabolic functions in the cell, and are novel, thus overcoming drug resistance. We have filed three patents till date. The most advanced project is at a lead optimized stage and is intended for the treatment of complicated skin infections and hospital acquired pneumonia caused by Methicillin-Resistant Staphylococcus Aureus (MRSA). The other three projects are at different stages of preclinical development from hit to lead." In a 2007 survey of 1,293 hospitals by the European Antibiotic Resistance Surveillance System, Methicillin-Resistant Staphylococcus Aureus was responsible for 25 percent of the infections and required an excess of USD 63 million in spend, due to longer hospital stays. A recent Indian Intensive Care Case Mix and Practice Patterns study (INDICAPS) of 4,209 ICU patients found that one out of every eight patients in India die from infections contracted in ICUs. Vitas is currently self-funded by the founders themselves, along with other grants. "We are a R&D driven product company. Our business model is to out-license our molecules after achieving proof-of-concept inthe target population. Therefore, our 'customers' are mid-to-large pharmaceutical companies with expertise in clinical development and regulatory, with sales and marketing capabilities in the major markets," explains Dr Radha. Talking about the initial challenges faced while erecting Vitas Pharma, Dr Radha comments, "The initial challenges of setting up a company were largely centered on finding the right Incubator and people with the relevant experience, and identifying vendors and service providers, who could cater to our needs at our pace." Dr Radha believes that before one sets out to establish a company, it is essential for the entrepreneur to have clarity. "Clarity in terms of what the unmet needs are, how the product of the company will meet those needs, and analyzing its market potential is crucial. Of course, it is also important to ensure that funds available to the company are adequate to build the product," she says. At the moment, Vitas has a total of four products, which are at different stages of preclinical development, from hit to optimized lead. "All these products are intended for treating multi-drug resistant infections such as hospital acquired pneumonia, complicated urinary tract infections, skin and soft tissue infections, and blood stream infections. What is novel about the Vitas pipeline is that the compounds represent completely new chemical structures and hence, are able to overcome multi-drug resistance," elucidates Dr Radha. At Vitas, the team consists of scientists with Master's or PhD degrees, in chemistry or biology, with relevant industry or academic experience. When asked about Vitas' unique work culture, Dr Radha says, "At Vitas, all the team members are encouraged to think and find innovative solutions to technological challenges and scientific questions. Everyone is encouraged to propose new project ideas and pursue initial feasibility experiments, so long as the idea is aligned with the company's interests. We constantly discuss the latest in science and technology informally over lunch or in meetings, thus creating an environment conducive to research and original thinking." "In the field of new drug discovery for antibiotics, there are only a handful of companies worldwide. We have the distinction of being one of them," she further adds. Dr Radha feels that, Indian private investors are extremely risk averse. "Their appetite for investment in R&D driven biotech companies are low. This is in contrast to other parts of the world such as the Silicon Valley or Boston, where investment in Biotechnology is considered an essential component of the growth story," opines Dr Radha. With that contrast in mind, she emphasizes that, in India the government needs to take the role in creating an ecosystem for R&D driven companies to thrive. "This includes creating capital for start-ups, establishing Incubators, accelerators and putting in place policies that are small-company-friendly and tax incentives to promote private investment in R&D," she comments. Speaking on the public-private partnerships, Dr Radha observes, "Vitas was incubated in the University of Hyderabad and the IKP Knowledge Park. We work with academic institutions and public hospitals. Wereceive funding through two schemes of BIRAC. Thus, our operational model is based heavily on the public-private partnership model." At the moment, Vitas Pharma is collaborating with both academia and industry. "We have an ongoing collaboration with, Dr Harinath Chakrapani at Indian Institute of Science Education and Research (IISER), Pune; Dr Sharon Peacock, University of Cambridge, UK; Dr D Balasubramanian, L V Prasad Eye Institute; Dr V Lakshmi, Nizam's Institute of Medical Sciences; and Syngene (Biocon group of companies). We have also had past collaborations with the faculty at the University of Hyderabad," Dr Radha says. In the future, Dr Radha sees Vitas entering the clinical development phase with its assets, and successfully out-licensing and building partnerships with other pharmaceutical companies. "Our focus will remain on infectious diseases, although we may expand our scope to include anti-virals and anti-parasitics in the future. Pain and inflammation is another area that we might venture into. We will continue to progress with our four preclinical programs this year. We hope to file one IND this year," ends Dr Radha with a lot of hope. ]]> <![CDATA[Aam aadmi of bioscience! ]]> https://biospectrumindia.com/features/95/3751/aam-aadmi-of-bioscience-.html https://biospectrumindia.com/features/95/3751/aam-aadmi-of-bioscience-.html Fri, 04 Apr 2014 09:16:00 +0530 When will the political parties in our country actually pay their attention towards the sector? The answer is right before us. After our special story on the industry's expectations and the missing bioscience agenda on political landscape, the manifestos have proven to be a dud. The print and e-copies of the story to the manifesto committees of the major political parties too have not yielded any result. The congress party which is demitting office after one decade, in its manifesto laid emphasis on almost everything but science. Perhaps it won't generate enough help in the hostile anti-incumbency challenge. The main challenger, Bharatiya Janta Party (BJP) which is leading in the opinion polls at the moment, too its manifesto, doesn't seem to have much for the sector. Also, the Aam Aadmi Party which is the flavour of the season, has hardly put anything there to read out. Left parties are no different. Meanwhile, most venerable section of the sector are those who need support and encouragement. The bio-manufacturing, entrepreneurship, education and research needs special boost. Like any other fellow countrymen, the only one at the moment they are looking at, is the next government. There is a unanimity that political diaspora has to understand their needs to ensure the best outcomes especially in healthcare and agriculture. The complex regulatory scenario and prevailing confusion has added to the woes of companies who have to always run from pillar to post for seeking clearances. No doubt ensuring the safety and well-being of people is supreme but that has to be based on logic and not unfounded emotional misconceptions. There have been individual government agencies and officials who have indeed worked tirelessly to promote the sector. However, the lack of coordination and unanimity on key issues within the outgoing government came as great disappointment for them. While at the moment, we are not sure about the political party forming the next government at the centre but we are confident that the political ideology will guide most of the decisions. The public perception surely is important for any democratic government but so is the long term vision for their betterment. And unfortunately the lack of enough knowledge about this industry in the general public has become a negative factor. Perhaps the industry requires to establish a direct connect and open a dialogue with the common masses. The mobilization of strong public opinion can surely force any political parties to make amends to the rigidity of few outdated principles. As one of the political analysts had pointed out, the political parties will keep following populist themes and if you have to make them see your point, you have to make it positively popular. As the nation awaits next dispensation to take over the reins, the industry too will curiously look on. Finally, when the dust settles down and the election euphoria fades out, all we will be left out with is hope. Let it not die even if the expectations are not met. ]]> <![CDATA[Mumbai dabbawalas join hands for the World Health Day campaign, 'small bite: big threat']]> https://biospectrumindia.com/news/95/7354/mumbai-dabbawalas-join-hands-for-the-world-health-day-campaign-small-bite-big-threat.html https://biospectrumindia.com/news/95/7354/mumbai-dabbawalas-join-hands-for-the-world-health-day-campaign-small-bite-big-threat.html Thu, 03 Apr 2014 16:10:00 +0530 Addressing the growing threat of 'vector-borne diseases', the theme of World Health Day (WHD) 2014, the World Health OrganizationCountry Office for India, jointly with the Health Department of Maharashtra andthe Nutan Mumbai Tiffin Box Suppliers Charity Trust today called for greater and focused attention to prevention and control of vector-borne diseases in India - dengue, malaria, chikungunya, lymphatic filariasis, kala-azar (also known as visceral leishmaniasis) and Japanese encephalitis. The World Health Day campaign, 'small bite: big threat' is aimed at raising awareness about the threats posed by insect vectors and the bacteria, viruses,and parasites they carry, collectively known as vector-borne diseases (VBDs); andto motivate families and communities to protect themselves through simple measures. An important activity to commemorate the WHD 2014 is an awareness programme with the Mumbai dabbawalas to reach Mumbaikars with key messages about preventing and controlling vector-borne diseases, especially malaria and dengue.On 7 April 2014, the dabbawalas will deliver along with lunch boxes, a specially created tag with key messages. Dr Nata Menabde, WHO representative to India highlighted, "In India, the burdenand risk of vector-borne diseases is massive. The burden is concentrated in the remote areas of the country with the poorest health systems where the population is most exposed. Weak collaboration across agencies, sectors, and levels of government, including the regulatory mechanisms are some of the key challenges. Now is the time for robust collaboration and action across all sectors and for targeted community-level sensitization. These diseases pose major public health problems and hamper socio-economic development." "The recently conducted Joint Monitoring Mission on vector-borne diseases in India is a step towards reviewing disease control efforts through the health systems lens to identify and address critical gaps," she added. Mrs Sujata Saunik, secretary, Public Health, Government of Maharashtra presented the keynote address. Also present on the occasion was Mr Sanjay Deshmukh, additional municipal commissioner, Western Suburbs, Municipal Corporation of Greater Mumbai. Mr Raghunath Medge, president, Nutan Mumbai Tiffin Box Suppliers Charity Trust, acknowledged the importance of spreading messages on controlling vector-borne diseases. He said, "Reaching out to a large number of Mumbaikars will certainly have a multiplier effect. Communities at large need to be sensitized and informed about basic preventive tips. We are happy to be associated with WHO for this cause and will do our bit in making the citizens of this city more informed on how to protect themselves and their families." ]]> <![CDATA[ Dengue and malaria impacting socioeconomic growth: WHO]]> https://biospectrumindia.com/news/95/3749/-dengue-and-malaria-impacting-socioeconomic-growth-who.html https://biospectrumindia.com/news/95/3749/-dengue-and-malaria-impacting-socioeconomic-growth-who.html Thu, 03 Apr 2014 16:06:00 +0530 While countries in South-East Asia have made substantial economic progress, diseases such as dengue and malaria fuel a vicious cycle of poverty and have a significant impact on socioeconomic status of communities. These diseases are still killing thousands of people in the WHO South-East Asia Region. Forty percent of the global population at risk of malaria lives in the WHO South-East Asia Region - home to a quarter of the world's population. Malaria is endemic in 10 of the 11 countries of the Region: Bangladesh, Bhutan, Democratic People's Republic of Korea, India, Indonesia, Myanmar, Nepal, Sri Lanka, Thailand and Timor-Leste. Maldives is the only country in the Region that has remained free of malaria (malaria-free since 1984). SriLanka made remarkable progress in controlling malaria by bringing cases down from 203 000 in 2000 to zero locally acquired malaria cases since November 2012. "These are deadly but preventable diseases. The solution lies in a united and sustained effort from all of us. Ministries of health alone cannot control these diseases. Their control and prevention needs committed engagement from all sectors, strong political will and active community participation," said Dr Poonam Khetrapal Singh, WHO Regional Director for South-East Asia. "This Region recently defeated polio, it is time for us to show the same resolve to defeat malaria, dengue and other vector- borne diseases," she added. Vector-borne diseases account for 17% of the estimated global burden of all infectious diseases. Dengue is now the world's fastest growing vector-borne disease, with a 30-fold increase in disease incidence over the past 50 years. Outbreaks of dengue fever have now been reported from all countries in WHO's South-East Asia Region except Democratic People's Republic of Korea. Lymphatic filariasis, another mosquito-borne disease, is linked to poverty and creates disfiguring and social stigma. The Region has 60 million infected people while 875 million people are at risk of infection. To interrupt transmission, WHO recommends an annual mass drug administration of single doses of two medicines to all eligible people in endemic areas. "With mass drug administration with effective coverage, there is no reason why diseases like lymphatic filariasis cannot be eliminated from the Region," said Dr Poonam Khetrapal Singh. "Countries must prioritize vector-borne diseases in their national development agendas. Communities need to be empowered to fight this battle and protect themselves. Preventing and controlling vector-borne diseases is everyone's responsibility," she added. ]]> <![CDATA[Venus gets marketing nod from Venezuela for meropenem]]> https://biospectrumindia.com/news/95/3748/venus-gets-marketing-nod-from-venezuela-for-meropenem.html https://biospectrumindia.com/news/95/3748/venus-gets-marketing-nod-from-venezuela-for-meropenem.html Thu, 03 Apr 2014 15:59:43 +0530 Venus Remedies, a research-based global pharmaceutical company, has extended its footprint in Latin America with marketing authorisation for meropenem from Venezuela, a $6-billion pharmaceutical market. Lauding the achievement, Venus Remedies chairman and managing director Pawan Chaudhary said, "We are planning to launch meropenem in Venezuela in the next couple of months. The $-10 million meropenem market in Venezuela offers a great opportunity to us and we are aiming at capturing a sizeable share in this market in the first year of the launch. Having a presence in important Latin American markets like Columbia, Peru, Guatemala and Mexico, we are constantly strengthening our position in Latin America." Meropenem, which accounts for annual global sales of $906 million which are estimated to go up to $1,006 million in the next one year, is an off-patented antibacterial agent of the carbapenem class of antibiotics, which caters to diseases with a broad range of serious infections caused by single or multiple susceptible bacteria in both adults and children. Venus has already got marketing authorisation for meropenem from the UK (MHRA), France, Austria, Denmark, Finland, Ireland, Germany, Netherlands, Poland, Slovenia, Slovakia, Sweden, Portugal, Czech Republic, Cyprus, New Zealand and Mexico. The product has also made its way to the Balkan countries with marketing approvals from Bosnia & Herzegovina and Croatia. Venus is now eying lucrative and regulated markets like Australia, Spain, Switzerland, South Africa and Malaysia, where the registration process is in advanced stages. ]]> <![CDATA[In a first, Indian scientists sequence mitogenome of important crop pest ]]> https://biospectrumindia.com/news/95/3746/in-a-first-indian-scientists-sequence-mitogenome-of-important-crop-pest-.html https://biospectrumindia.com/news/95/3746/in-a-first-indian-scientists-sequence-mitogenome-of-important-crop-pest-.html Thu, 03 Apr 2014 11:46:00 +0530 Phytophagous ladybird beetle, Henosepilachna pusillanima (Mulsant), synonym of Epilachnadodecastigma (Wiedemann), is one of the important pest species of cucurbitaceous crops in India. The complete mitochondrial genome of H. pusillanima has been sequenced by a team of scientists comprising Dr G T Behere, Dr D M Firake, Dr N S Azad and Dr S V Ngachan of Division of Crop Improvement (Entomology), ICAR-RC for NEH region, Umiam, Meghalaya. The size of complete mitochondrial genome of the H. pusillanima was determined to be 16216-bp long and circular in nature (Fig. 1) and which has a total of 13 protein coding genes (PCGs), 22 transfer RNA (tRNA) genes, 2 ribosomal RNA (rRNA) genes and one control region (A+T-rich region). The size of control region was estimated to be 1690-bp. The gene arrangement and orientations of assembled mitogenome were identical to the reported coleopteran insect species including predatory ladybird beetle Coccinella septempunctata L. The complete assembled and annotated genome has been submitted to the NCBI vide Genbank Accession Number: KJ131489. This would be the first completely sequenced coleopteran genome from the beetle subfamily Epilachninae and also the first insect mitogenome from India. ]]> <![CDATA[Aurobindo Pharma takesover select western European businesses of Actavis]]> https://biospectrumindia.com/news/95/3744/aurobindo-pharma-takesover-select-western-european-businesses-of-actavis.html https://biospectrumindia.com/news/95/3744/aurobindo-pharma-takesover-select-western-european-businesses-of-actavis.html Wed, 02 Apr 2014 17:58:00 +0530 Aurbindo Pharma Limited announced the completion of the previously announced acquisition of certain commercial operations in Western Europe from Actavis plc. Aurobindo acquires personnel, commercial infrastructure, products, marketing authorisations and dossier licence rights in seven European countries. Actavis and Aurobindo have also entered into a long term commercial and supply arrangement. Following receipt of clearances from competent authorities, Aurobindo now intends to combine the strength of both enterprises (including its vertically integrated platform and existing commercial infrastructure) in these markets and to identify and maximise all opportunities to improve performance. The acquisition will make Aurobindo one of the leading Indian pharmaceutical companies in Europe said Mr Muralidharan, senior vice-prsident of European Operations, Aurobindo. The acquisition will enable Aurobindo to achieve critical mass in Western Europe with a top 10 position in several key markets. He further added "I am delighted to welcome relevant Actavis customers, suppliers, partners and employees to Aurobindo. We will continue to collaborate with Actavis to ensure business continuity and a smooth transition. In parallel, we will work closely with the acquired management teams to achieve a rapid and successful integration". Arvind Vasudeva, ceo, Aurobindo's Formulations Business commented "We had carefully reviewed the Actavis European operations and concluded that with our cost competitiveness and group structure we could significantly capitalize Actavis' strong market position in these Western European countries and improve profitability, thereby accelerating our strategy of becoming a significant Gx player in Europe". ]]> <![CDATA[Biotech sector requires special attention says FICCI]]> https://biospectrumindia.com/news/95/7347/biotech-sector-requires-special-attention-says-ficci.html https://biospectrumindia.com/news/95/7347/biotech-sector-requires-special-attention-says-ficci.html Tue, 01 Apr 2014 18:19:00 +0530 FICCI's recommendations for the next government for year 2014-15 (as conveyed exclusively to the BioSpectrum by Shobha Mishra Ghosh, senior director, FICCI ) : 1. As per FICCI, some of the key expectations from the government for Biotech include continuous flow of funds, increase in weight tax deduction from 200% to 250% and extending its applicability to activities like clinical trials, setting up venture capital funds, tax rebates, grants for advanced skills development programs, exemption from excise/custom duties onlife saving medicines as well as on their raw materials and also on capital goods and consumables, CRO's and diagnostic kits. Additionally, the rate of Central Excise duty on bulk drugs which is 10% may be brought down at par with drug formulations which is 5%. 2. Further, with a view to encourage biotech exports; apart from the already approved Biotech Parks (BTP) schemes in states like Karnataka, Tamil Nadu, Andhra Pradesh, Uttar Pradesh and Maharashtra, it is recommended that the new government could look at increasing the number of BTP schemes for manufacturing and also cover the trading units under the purview of such schemes. 3. It is important that export incentives under the BTP schemes are revived for this sector to realize its full potential. Since, research and development in biotech, especially the Biopharma sector is highly capital intensive; export tax benefits will help the major industry players in de-risking and funding their original research, thus increasing manufacturing in the sector. 4. At present, 100 per cent FDI is permitted through the automatic route in Pharmaceuticals. As per the DIPP data, FDI in the pharmaceutical sector jumped by 86.5 per cent to USD 1.08 billion during April-October period (2013-14) of the current fiscal amid concerns over continuous mergers and acquisitions of domestic drug makers by multinationals. Nonetheless, delays in approvals for clinical trials, regulatory issues regarding uniform code for sales and marketing of pharmaceuticals and compulsory licensing did have an adverse impact on the pharmaceutical industry. With respect to the Pharmaceutical sector, it is recommended for India to now move ahead towards break-through innovation in pharmaceuticals and new products with increased visibility should start contributing in Life-Sciences. Now daysvarious Pharma companies are incurring substantial expenses in creating innovative products/processes which can be patented. As an incentive for keeping such patents, technical know-how and other Intellectual Property Rights (IPR) in India a deduction/exemption should be provided by the government in respect of royalty and other income related to such IPR. This would help in improving trade balance and also keeps the emerging IPRs in India. 5. Since biopharmaceuticals involve formulations based on biological products, their guidelines regarding pricing should not be same as that of the chemical drugs. Therefore, it is suggested that the government (National Pharmaceutical Pricing Authority) should come out with sector-based pricing mechanism for different streams of drugs like Biosimilars or Biologics urgently so that the sector realizes its full potential. 6. As an Industry's voice, FICCI believes that there is a need for partnership between industry and government, especially for the biotechnology sector particularly in vaccines, biosimilars and regenerative medicine, and institutionalizing policies that enable faster market entry at lower costs, without compromising product quality, safety and efficacy. 7. Enhancing innovation and improving market access for biotech products are one of the many defining goals of healthcare reforms. FICCI is of the view that it is important for the coming government to provide support and work towards empowering the entire innovation ecosystem. One of the primary mandates of the new Indian Government could be to trigger, transform and tend biotech-startups to convert innovative research in public and private sector into viable and competitive products and enterprises. For the past one year, FICCI has been actively organizing innovation Boot-camps and Sandboxes to identify the innovators in the country who can interact with Policy-makers, Investors and the Industry on one platform. 8. With objectives to foster a generation of ideas with commercialization potential, to up-scaleand validate proof of concept for innovation, stimulating enterprise formation and to encourage researchers to take up technology closer to the market through a start-up; the Indian government can certainly enable the Biotechnology sector to become "The Bio-Innovation" market across the globe. FICCI feels that incorporating the aforementioned recommendations into its agenda, the Government 2014-19 will help the Indian biotechnology industry grow significantly in the coming financial years. ]]> <![CDATA[Glenmark Pharma arm receives US$4 mn]]> https://biospectrumindia.com/news/95/3739/glenmark-pharma-arm-receives-us4-mn.html https://biospectrumindia.com/news/95/3739/glenmark-pharma-arm-receives-us4-mn.html Tue, 01 Apr 2014 16:59:41 +0530 Glenmark Pharmaceuticals ltd has announced that the company through its Swiss Subsidiary has received US$ 4 million as research fee payment from Forest Laboratories Inc. on a collaboration for the development of novel mPGES-1 inhibitors to treat chronic inflammatory conditions, including pain. Under the terms of the agreement signed in FY 2012-13, Forest made USD 6 million upfront payment and also provided an additional USD 3 million to support the next phase of work. In September 2013, Glenmark received an additional amount of USD 2 million as research fee payment from Forest Laboratories Inc. Hence, the total amount received by Glenmark from Forest Laboratories Inc towards its novel mPEGS-1 inhibitors program is USD 15 million. ]]> <![CDATA[Dr Reddy's plan to enter Japanese market]]> https://biospectrumindia.com/news/95/3740/dr-reddys-plan-to-enter-japanese-market.html https://biospectrumindia.com/news/95/3740/dr-reddys-plan-to-enter-japanese-market.html Tue, 01 Apr 2014 16:56:00 +0530 Dr Reddy's Laboratories Limited is planning to make a fresh foray into the Japanese market. "We are exploring all options in the sense we have product profile. The priority is to get into the right plan to enter into the (Japanese) market," DRL Vice-Chairman and Managing Director, K Satish Reddy reportedly said. Earlier in June, Indian drug-maker and Fujifilm Corporation decided to terminate the MoU to enter into an exclusive partnership in the generic drugs business for the Japanese market. DRL and Fujifilm signed the MoU on July 28, 2011 and the two companies had conducted detailed studies on establishment of a joint venture for developing and manufacturing generic drugs in Japan. ]]> <![CDATA['Right time to focus on NCDs' ]]> https://biospectrumindia.com/reports-white-papers/95/8236/right-time-to-focus-on-ncds-.html https://biospectrumindia.com/reports-white-papers/95/8236/right-time-to-focus-on-ncds-.html Mon, 31 Mar 2014 20:06:58 +0530 The White Paper titled "Control of NCDs Through Primary and Preventive Healthcare"by Bain & Company presented at "The Future of Healthcare: A Collective Vision" Conference at Delhi (March 3-4, 2014) notes that the global burden from non-communicable diseases (NCDs) is significant and rising at a rapid pace. Low- and middle-income countries like India share a disproportionate 80% of the NCD mortality burden. India alone accounts for 17% of global deaths due to NCDs and 24% of disability-adjusted life years (DALYs). Globally, NCDs are estimated to account for nearly 75% of all deaths in the world and will cost the world GDP an estimated US$47 trillion by 2030.[2]This high burden poses a substantial threat to India's socioeconomic development, with a potential loss of US$6.2 trillion by 2030-nearly 3.5 times our current GDP. "India has a narrow-and closing-window of opportunity to shape its health and care eco-system to cope with a tsunami of non-communicable diseases (NCDs) and it must seize this opportunity to shift the focus from sickness to wellness and prevention and create a culture of healthier living" said Karan Singh, Bain & Company's Asia-Pacific Healthcare practice head and main author of the report. India has a narrow window of opportunity to act quickly, through a joint effort of government and relevant stakeholders, to protect the health of current and future generations. Now is an opportune time as healthcare systems are still being defined (role of government, evolving regulations, citizens' right to health, use of technology in health, etc.), and new models of service delivery are being explored. "The negative consequences of not doing so are significant and unaffordable as it will cost us over $6 trillion between now and 2030 - about 3.5 times current GDP", Singh said. However, addressing NCDs will be a complex and difficult task. It will require multifaceted solutions involving a range of stakeholders across government, private sector, community and the individual. The solutions have to address underlying root causes but, more importantly, ensure a behaviour and mindset change among individuals and caregivers - one that inspires a shift from the current paradigm focusing on a care/sickness model to focusing on and creating a culture of health/wellness. "Addressing the NCD challenge will require a disproportionate focus on prevention and change behavior of individuals, patients and caregivers. The NCD solution must be holistic - impacting several levers to create healthy living - and must involve multiple stakeholders including government, private hospital chains, educational institutes, consumer product/IT companies, medical device manufacturers and NGOs. All these stakeholders will have to collaborate and define new and innovative business models," said Bain's Singh. Global experience with NCD control, especially in developed markets, has demonstrated that interventions aimed at prevention and early diagnosis are the most cost effective, giving the highest return on investment (ROI). There is clear evidence linking reductions in cardiovascular- and diabetes-related morbidity and mortality to a focus on high-ROI interventions such as large-scale awareness campaigns, lifestyle interventions, screening programmes, and medication for high-risk groups. It is critical to recognize that many risk factors for NCDs (unhealthy diet, physical inactivity, tobacco use, harmful use of alcohol) are controllable with the right individual actions.The challenge for India is to create a mindset where healthy living is seen as an essential investment rather than a cost by individuals. This will also mean influencing individual daily decision-making so that people make healthy choices by understanding the consequences of short-term pleasure on the longer-term impact on health. Focusing on education/awareness, alignment of incentives and creating effective feedback loops will be critical in achieving this behaviour change. To achieve this goal, multiple stakeholders need to collaborate in developing a holistic and sustainable healthcare system. The government, given its key position, will have a pivotal role in defining the vision and overall framework; rolling out public health initiatives that target behavioural and physiological risk factors; using its convening power to enable multi-sectoral, multi-stakeholder action; and ensuring that the needs of underserved areas/communities are addressed. "Beyond the government, it is critical that other stakeholders including healthcare players (providers, payers, product suppliers), relevant non-healthcare companies (in consumer goods, technology, telecom, IT, education), and community organizations come together to drive collective action. Attempts must be made to test new approaches (by using/localizing global experiments and developing new ones), as well as to plan for scalability of successful efforts," mentions the white paper. ]]> <![CDATA[Healthcare spending by BRICS nations to increase says PwC whitepaper]]> https://biospectrumindia.com/reports-white-papers/95/3737/healthcare-spending-by-brics-nations-to-increase-says-pwc-whitepaper.html https://biospectrumindia.com/reports-white-papers/95/3737/healthcare-spending-by-brics-nations-to-increase-says-pwc-whitepaper.html Mon, 31 Mar 2014 19:58:40 +0530 The PwC report in Indian context mentions that India's infrastructure requirement is also significant and as per estimates, the country requires to add 650,000 beds which will translate to the capital investment of INR 162,500 Cr by 2017. Skewed distribution of healthcare infrastructure where 70% of beds are located in top 20 cities further limits the access to quality care. "However, the sector is poised for significant growth trajectory and recognised as one of the fastest growing social sectors, estimated at approximately 75 billion USD. It is estimated to grow at a CAGR of 15% annually and by 2020, the industry is expected to reach 220 billion USD. Development of healthcare infrastructure is therefore, critical in order to spur the GDP growth rate of a country," says the PwC report. Since government spending on healthcare alone will not be able to cater to the growing need for investment in the healthcare sector in India, governments are increasingly looking towards Public Private Partnership (PPP) model to solve larger problems in care delivery and wellness. The cost impact of PPPs is far more substantive and sustainable. It is also welcome owing to the technological advancements and thereby efficiency and innovation that the private sector is expected to infuse. PPPs are also changing the notion that private healthcare is only for the rich and are equalizing healthcare for all populations. â€¨â€¨We are now moving to a wider paradigm where People become a vital component of this eco-system to make it a public, private people partnership. PPPs are increasingly developed by local, rather than national governments, that are closer to local health needs. This becomes all the more critical in a consumer-focused industry such as healthcare. However, to make the best of this model, several tangible and intangible aspects need to be looked at. It is imperative to establish a national PPP framework that enables local health systems to tailor solutions and demonstrate political will. â€¨â€¨Governments and private players, alike, also need to focus on the common objective of making quality healthcare accessible, affordable to all. This calls for mutual trust and an understanding of mutual constraints and expectations. While governments should not overlook the financial viability of the business model for the private operator, private players understand the social obligations under healthcare PPP's and ensure strong long term partnership. Only then will the model survive and sustain and the real payback reach the fourth and most important pillar of the framework- the people. ]]> <![CDATA[Surge in TB cases: Top govt officials lament the lack of awareness ]]> https://biospectrumindia.com/news/95/5822/surge-in-tb-cases-top-govt-officials-lament-the-lack-of-awareness-.html https://biospectrumindia.com/news/95/5822/surge-in-tb-cases-top-govt-officials-lament-the-lack-of-awareness-.html Mon, 31 Mar 2014 13:36:00 +0530 India has the highest burden of TB in the world, an estimated 2 million cases annually, accounting for approximately one fifth of the global incidence. It is estimated that about 40% of the Indian population is infected with TB bacteria, the vast majority of whom have latent rather than active TB disease. It is also estimated by the World Health Organisation (WHO) that 300,000 people die from TB each year in India. Dr R S Gupta, director general, Revised National Tuberculosis Control Programme (RNTCP), recently in his highly passionated speech talked about the need to speard awareness about TB on the ground level. "TB in initial days can be cured if the treatment is followed regularly but unfortunately in India it is not so. People choose to ignore it and refuse to take medication, leading to multi drug resistance TB (MDR-TB). That also raises the cost of treatment and level of disease as well," said Dr Gupta who spoke at the Economic Times healthcare summit held at New Delhi. Traditionally the view in India had been that MDR TB is not easily transmissible and that most drug resistant TB arises from the failure of people to take their drugs properly, rather than from them becoming infected with an MDR TB strain. Therefore a high quality DOTS program, and supervising people taking their drugs should prevent the emergence of resistance. The RNTCP has tried to involve non public health providers in promoting TB care, but it is believed that many patients continue to seek treatment elsewhere and currently go unreported. Whilst national data for India is not available a number of studies and surveys of TB prevalence including self reporting of TB prevalence have suggested that up to 46% of patients may not be currently reported. There is a close relationship between TB and HIV-AIDS as the latter gives an opportunity for it to attack a fragile immune system. Mr V K Subburaj, secretary, Department of AIDS Control, in his keynote address at the same event remarked, "It is unfortunate that the private hospitals don't come forward to enlist on the TB control programme. Six thousand kits freely available by the government but we still see the cases in millions every year. The lack of awareness despite government attempts has indeed been a cause of concern." On 11 Oct 2013, Indian Pharmacopoeia Commission (IPC) and Revised National Tuberculosis Control programme (RNTCP) decided to work together to monitor the safety of antitubercular drugs. Indian Pharmacopoeia Commission is working as National Coordination Centre (NCC) for Pharmacovigilance Programme of India (PvPI) by collecting the ADRs across the country through their ADR monitoring centres. ]]> <![CDATA[Stay vigilant against recurrence of polio, cautions President ]]> https://biospectrumindia.com/news/95/5926/stay-vigilant-against-recurrence-of-polio-cautions-president-.html https://biospectrumindia.com/news/95/5926/stay-vigilant-against-recurrence-of-polio-cautions-president-.html Mon, 31 Mar 2014 12:38:00 +0530 The president of India, Mr Pranab Mukherjee addressed the Polio Free Conclave 2014 organised by the Rotary International, at New Delhi on March 30, 2014. He also presented mementos of appreciation and recognition to the former health minister Dr A Ramadoss and Mr Ghulam Nabi Azad, hnion health minister for health and family welfare. Speaking at the occasion, the president applauded the efforts of various agencies including the government in ridding the country of the disease. The president said that this was a momentous and landmark achievement. Health has been the priority of the Government of India for quite some time, he said. Unprecedented programme to eradicate the polio virus from the country was taken up by the central and state governments supported by several national and international agencies such as Rotary International, UNICEF, WHO, CDC and Melinda and Gates Foundation, he added. The President said that the agencies helped with material resources and best practices to wipe out this crippling disease. Initiative was taken up at several levels to spread awareness, provide prompt medical attention and administer the polio vaccine. The unique challenge in India, the President noted, was the sheer number of people combined with the difficult terrain in many states. He applauded the unparalleled dedication of all concerned and the relentless efforts put in by the workers, doctors, activists and various stakeholders including parents of children in achieving this day. The President stated that India must assist other countries such as Pakistan, Nigeria and Afghanistan in their fight against this disease in improving their health systems and infrastructure. He stated that we must be vigilant. There is need for watchfulness and preparedness to see that there is no recurrence of this disease, the President said. The Union health minister addressing the gathering said that this was a momentous and historic achievement. He thanked all the stakeholders and partners in this challenging yet deeply satisfying journey. He credited this achievement to decision to introduce the new bivalent polio vaccine which was indigenously developed for the first time, aggressive immunization and micro block level planning covering the most endemic areas which had an electrifying effect, strong political will at the highest levels that ensured pumping in of required financial resources and deployment of huge manpower in this gigantic task, constant monitoring and maintaining supply chains, involving over a million Accredited Social Health Activists (ASHAs) and Auxiliary Nurse Midwives (ANMs) across the country. He said that a 2.3 million strong team of frontline polio workers, volunteers and 150,000 supervisors worked day and night for the success of the polio rounds. Shri Azad complimented the Rotarians who have been contributing resources, time and effort to the cause. Present at the occasion were Shri Lov Verma, Health Secretary, Dr. Harsh Vardhan, Mr. Gary Huang, Rotary International President Elect, Mr. D. K. Lee, Chairman, Rotary Foundation, Sh Rajendra Saboo, Conclave Chairman, Sh P T Prabhakar, Rotary International Director and Sh Kalyan Banerjee, Conclave co-chairman. ]]> <![CDATA[Assessing basic healthcare in India: Experts deliberate at ET Summit ]]> https://biospectrumindia.com/news/95/3733/assessing-basic-healthcare-in-india-experts-deliberate-at-et-summit-.html https://biospectrumindia.com/news/95/3733/assessing-basic-healthcare-in-india-experts-deliberate-at-et-summit-.html Sat, 29 Mar 2014 18:25:06 +0530 ET Edge, a subsidiary of The Economic Times, founded to empower multiple sectors, industries and segments through the dispersion of critical business knowledge through strategically developed conferences and summits on March 29, 2014 held 'The Economic Times Healthcare Summit'. The summit was opened by Mr Rajendra P. Gupta, president, Disease Management Association of India. Speaking on the occasion, Mr Gupta mentioned, "Over the last decade, most Indian health-care providers have concentrated on expanding infrastructure to reach out to more patients through increased focus on technology, education & training. However there is a need to focus more intently on improving patient satisfaction specifically in the rural areas through innovative technology". Recognizing the increasing importance of growing healthcare needs in India, the Economic Times: Healthcare Summit aims to focus on the major developments in the healthcare sector and understand the existing challenges in the current scenario while preparing for the future. The event comprised of various focused panel discussions and case study presentations by senior industry barons such as; Anil Saini, COO & CIO, Ricoh India, A Velumani, MD, Thyrocare, Ameera Shah, MD, Metropolis Healthcare, Ajit K Nagpal, Chairman , Amity Pacific Forum, Charu Sehgal, Senior Director, Strategy and Operations Division and Head, Healthcare Vertical, Deloitte and many others. The daylong event comprised of various focused case study presentations and interactive panel discussions delving on issues related to Diagnostics & Screenings - Role of technology & private sector, Chronic Diseases - Role of technology & private sector, Rural Health - Technology and Private Sector, Telemedicine & Health: Now or Never, Role of Technology in Changing Health Behaviour and eHealth Standards and Best Practice Models. Other opinion leaders present on the occasion included Mr V K Subburaj, secretary, Department of AIDS Control, Dr Sanjeev K Chaudhry- MD, SRL, Manoj Shah- MD, Mastel India, Alok Roy, Chairman, Medica Superspeciality, Supten Nath Sarbadhikari, Project Director, National Health Portal, MoHFW; N K Dhamija, MOHFW, GOI; Vikram Tiwathis, Associate Director, COAI, Neena Pahuja, Director General, Ministry of Communication and IT and others ]]> <![CDATA[Max and GE Healthcare join hands to advance cancer care in India]]> https://biospectrumindia.com/news/95/3735/max-and-ge-healthcare-join-hands-to-advance-cancer-care-in-india.html https://biospectrumindia.com/news/95/3735/max-and-ge-healthcare-join-hands-to-advance-cancer-care-in-india.html Sat, 29 Mar 2014 17:34:45 +0530 Max Healthcare, a leading healthcare services provider and GE Healthcare, a unit of General Electric Company (NYSE: GE), today announced a strategic partnership to advance the standard of cancer care in India through collaborative research and co-creation of futuristic, multifaceted cancer management solutions. An MoU was signed to this effect by Dr. Ajay Bakshi, MD & CEO, Max Healthcare and Ms. Terri Bresenham, President & CEO, GE Healthcare South Asia, in the presence of Mr Analjit Singh, Chairman, Max India Group; Mr John Dineen, President & CEO, GE Healthcare; Mr. Rahul Khosla, Managing Director, Max India Ltd.; Mr Banmali Agrawala, President & CEO, GE South Asia; and Dr Harit Chaturvedi, Chairman Oncology, Max Healthcare Speaking at the occasion, Dr Ajay Bakshi, MD & CEO, Max Healthcare said "There is an alarming increase in the incidence of cancer in India. Inadequate screening and a severe shortage of oncologists and other trained staff further compound the problem. With advanced healthcare infrastructure and the availability of one of the largest pools of clinical talent in the country, comprising of 45 oncologists and 220 trained oncology support staff, Max Healthcare is uniquely positioned to partner with GE Healthcare to set new standards for cancer care by innovating on clinical protocols, technology and systems." "At GE, we envision a day when Cancer is no longer a deadly disease. When the disease is as complex and multi-faceted as cancer, solutions need to be equally multi-faceted and even more integrated, combining medical imaging, molecular imaging, healthcare IT and cellular technologies. With technology advances, we can see diseases as we have never seen before and provide most personalized treatment eliminating non-responding treatment protocols. Through this partnership with Max Healthcare, we aim to understand the fingerprint of specific cancers in India and co-develop disruptive solutions" said John Dineen, President& CEO, GE Healthcare. As one of the most relevant global cancer diagnostic companies, GE is devoting an even greater share of R&D budget (US $ 1 Billion) to continue developing disruptive oncology solutions. Combining Max Healthcare's expertise and experience in tackling cancer presents a fantastic opportunity to advance technology solutions, processes and protocols to set a new standard of cancer care as well as improving access to quality cancer care for more people. The partnership will give emphasis to the following critical areas: 1. Creation of a first of its kind Centre of Excellence for Cancer in India at Max Super Speciality Hospital, Saket, Delhi. The Centre will be equipped with the latest technology solutions like medical imaging, molecular diagnostics, healthcare IT solutions to integrate data, processes etc. 2. Collaborative research on cancer care & co-creation of technology solutions 3. Improved access to quality cancer care through Healthcare IT Solutions (example. cloud/mobile health platforms). 4. Decision Support System like virtual tumor board - to virtually surround a patient with multi-disciplinary expertise. Oncologists from Max Healthcare network as well as leading experts from around the world will be available to provide best possible personalized treatment course to each patient 5. Development of innovative cancer specific treatment pathways and protocols to make diagnosis and treatment more efficient. 6. Setting up an Oncology Training Institute to advance existing skill set on clinical care and to build a larger pool of talent Addressing the media, Dr Harit Chaturvedi, Chairman- Oncology, Max Healthcare said, "At Max Cancer Centre, we receive around 10,000 patients every year and the numbers are increasing by the day. With this collaboration with GE Healthcare, we aim to bring together clinical and basic research to find new solutions to cancer. The virtual tumour board will enable experts from different geographies and time zones to review each case of cancer and propose specific solutions for patients." The incidence of cancer is sharply rising in India with a prevalence of 3 million and annual new addition of 1.23 million cases.* The mortality rates are very high due to late detection, access and affordability to care. India has highest rates of cervical, gall bladder, oral and pharynx cancers. Breast cancer is the second largest cancers among women in India. As per a GE commissioned study, 70-80% of cancer patients are diagnosed late which renders any form of treatment less effective. The need of the hour is to improve awareness leading to more early diagnosis, improve access to diagnosis and treatment as well as significantly improve the treatment protocols and care pathways to enhance quality of outcome - survival and leading a healthier life. "Every two minutes India loses three people to Cancer. Two new people are detected with cancer every minute in India. It is a ticking bomb. We can save many of these lives with early detection and precise treatment. The partnership with Max Healthcare reflects our shared commitment in tackling the deadly disease early and with precision" said Terri Bresenham, President & CEO, GE Healthcare South Asia. "We hope to learn much more about each type of cancer and their cellular behaviour and develop solutions through this collaboration" she added. Max Healthcare has been working towards addressing the scourge of Cancer. Recently Max Healthcare partnered with the Government of Punjab to organize the world's largest Cancer Screening Camp across 22 districts of Punjab, helping 20,000 patients. This partnership with GE Heatlhcare is a definitive step in tackling cancer head-on by working together to develop unique, disruptive solutions as well as by improving access to quality care ]]> <![CDATA[ Piramal Enterprises receives GLP Compliance Certificate from NGCMA]]> https://biospectrumindia.com/news/95/3731/-piramal-enterprises-receives-glp-compliance-certificate-from-ngcma.html https://biospectrumindia.com/news/95/3731/-piramal-enterprises-receives-glp-compliance-certificate-from-ngcma.html Fri, 28 Mar 2014 14:08:21 +0530 Piramal Enterprises Limited (PEL), announces that its Good Laboratory Practices (GLP) Department at Research & Development (R&D) facility in Goregaon, Mumbai has received the GLP Compliance Certification from the National Good Laboratory Practice Compliance Monitoring Authority (NGCMA), Government of India. GLP is a quality system concerned with the organizational process and conditions under which non-clinical health and environmental safety studies are performed. The R&D facility in Goregaon, Mumbai is engaged in drug discovery and development of New Chemical Entities (NCE) in the area of Oncology and Metabolic Disorders. Dr. Owe Owar, president, NCE Research, Piramal Enterprises Limited said, "The GLP certification is a testament to high quality research through thorough SOP-driven Good Laboratory Practices, competent well-trained personnel and systematic documentation at Piramal's NCE R&D facility in Mumbai. Piramal's NCE R&D unit is committed to realize its mission towards serving patients globally with medicines that matter." The certification states that specified studies in the areas of toxicity, mutagenicity, analytical and clinical chemistry testing, and others like hERG, bioanalysis and toxicokinetic evaluation conducted at Piramal Enterprises Ltd are compliant with GLP under OECD principles. Dr. Swati Piramal, vice-chairperson, Piramal Enterprises said, "I am very happy that our GLP lab has received this certificate. This is a leap forward in the field of quality compliance and best practices. The GLP laboratories are designed as per OECD guidelines. GLP helps assure the integrity and quality of the laboratory data used to support a regulatory submission." The 3,450-odd sq. ft. GLP facility is a part of 200,000 sq. ft. fully integrated NCE R&D unit which houses more than 400 scientists. Since its inauguration in June 2012 PEL has made significant investments in creating this in-house facility with state-of-the-art infrastructure. The GLP certification will enable PEL to do most of the Investigational New Drug (IND) support studies in-house, hence shorten the turnaround time for its R&D projects and help it become more cost efficient. Earlier, PEL used to conduct GLP studies externally. However, now with this in-house facility it will enable faster access to bio-analytical and toxicology data and better control on project timelines. ]]> <![CDATA[StemCyte only active player in India offering public banking facility ]]> https://biospectrumindia.com/news/95/6532/stemcyte-only-active-player-in-india-offering-public-banking-facility-.html https://biospectrumindia.com/news/95/6532/stemcyte-only-active-player-in-india-offering-public-banking-facility-.html Fri, 28 Mar 2014 13:51:31 +0530 StemCyte India Therapeutics, a unit of StemCyte Inc. - USA, has emerged as the only company in India in stem cell business to offer private banking, public banking and stem cell transplants with Umbilical Cord Blood (UCB) stem cells. The company started its operations in India in 2010 and has stored more than 1000 public umbilical cord blood units till date. StemCyte has a wide network of collection centres spread across Delhi, Rajasthan, Gujarat, Maharashtra, Andhra Pradesh, Karnataka and Tamil Nadu. The storage and processing centre is based out of it's headquarter in Ahmedabad. Mr. Kenneth J. Giacin, chairman & director of StemCyte Inc. - USA, said, "The success of Stem Cell Technology is not just in banking, but in its therapeutic application as well. StemCyte has released almost 2,000 cord blood units across 235 transplant centres worldwide, including 29 transplants in India. Operating a hybrid model of UCB stem cell banking, StemCyte worldwide has a public inventory of over 35,000 Umbilical Cord Blood Units." In 2012, global cord blood therapeutics market was estimated as a multibillion dollar business with double digit CAGR projected through 2020. However, the category in India is still at a very nascent stage with only 2 per thousand parents opting to preserve their babies' stem cells at birth, compared with 50 per thousand in the US, and 250 per thousand in Singapore. The Cord blood market in India is estimated at around US$ 60 million and has great potential for UCB banking due to a high birth rate of 26 million births per year and genetic diversity. "Despite the increasing number of births, India lags behind world indicators with extremely low public cord blood units and lack of bone marrow donors. There is a need to spread awareness and its importance to increase adoption of stem cell banking. We are committed towards our Indian operations and aim to build 5,000 plus units of public inventory in India and also to open more collection centres across India," added Mr. Giacin. Mr. Deepak Chhabra, coo, StemCyte India Therapeutics Pvt. Ltd., commented "One of the most important aspects in cord blood transplantation is the number of viable stem cells at time of transfusion. Through our patented 'Plasma Depletion Technology' we can assure that more than 99.95% of collected nucleated cells are restored during processing. This in turn results in higher probability of successful transplants." He further added, "UCB transplant plays a major role in treatment of Thalassemia patients, however as on date, there are only 5000 public units in Indian public inventories collectively and these units are not sufficient to treat more than 1 lakh patients who suffer from Thalassemia and other blood disorders." Dr. Wise Young, Global Medical Director, StemCyte Inc. - USA, who has been doing extensive work on spinal cord injuries, stroke, diabetes, etc. using umbilical cord blood stem cells, said "Research and clinical studies are increasing at an incredible pace and this will result in the treatment of some of the most devastating diseases. UCB can be used to treat more than 80 types of blood disorders which are approved by Indian Regulatory Board and USFDA. StemCyte Inc. - USA has completed the Phase II of their global clinical trial on spinal cord injury and moving forward, India will be one of the centres." StemCyte is also exploring the use of UCB Stem Cells in Stroke, HIV, Peripheral and Optic nerve damage treatments. ]]> <![CDATA[South-East Asia Region certified polio-free]]> https://biospectrumindia.com/news/95/8334/south-east-asia-region-certified-polio-free.html https://biospectrumindia.com/news/95/8334/south-east-asia-region-certified-polio-free.html Fri, 28 Mar 2014 10:28:00 +0530 WHO South-East Asia Region, home to a quarter of the world's population, was certified polio-free on March 27, 2014 by an independent commission under the WHO certification process. This is the fourth of six WHO regions to be certified, marking an important step towards global polio eradication. With this step, 80% of the world's population now lives in certified polio-free regions. An independent panel of 11 experts in public health, epidemiology, virology, clinical medicine and related specialties constituting the South-East Asia Regional Certification Commission for Polio Eradication (SEA-RCCPE) met for two days to review evidence from countries before reaching the decision that all 11 countries of the Region are now polio-free and have met the requirements for certification. Before a gegion can be certified polio-free, several conditions must be satisfied such as: at least three years of zero confirmed cases due to indigenous wild poliovirus; excellent laboratory-based surveillance for poliovirus; demonstrated capacity to detect, report, and respond to imported cases of poliomyelitis; and assurance of safe containment of polioviruses in laboratories (introduced since 2000). "This is a momentous victory for the millions of health workers who have worked with governments, nongovernmental organizations, civil society and international partners to eradicate polio from the Region. It is a sign of what we can bequeath our children when we work together," said Dr Poonam Khetrapal Singh, Regional Director for the WHO South-East Asia Region. Polio eradication programmes, through their networks and knowledge in reaching the 'unreached', have strengthened the delivery of health services to the most vulnerable communities. "Thanks to polio eradication, we now know where these children are who were difficult to reach with vaccine. Now the polio programme has successfully reached them with polio drops in every round, there is no excuse not to go back with other critical health services, from how to have a safe birth, to where to get access to tuberculosis treatment and how to prevent HIV infection," said Dr Khetrapal Singh. Through the effort to eradicate polio, health personnel and community workers have been trained and provided with critical equipment to improve vaccination and health services for other childhood diseases. Comprehensive global laboratory and communication networks have been built and are being used for other diseases. Most recently, these networks played a critical role in responding to avian influenza. Certification of the Region comes as countries prepare for the introduction of inactivated polio vaccine (IPV) in routine immunization as part of the eventual phasing out of oral polio vaccines (OPV). More than 120 countries currently use only OPV. These countries will introduce a dose of IPV by the end of 2015 as part of their commitment to the global polio endgame plan which aims to ensure a polio-free world by 2018. While celebrating the historic achievement, the WHO Regional Director also sounded a word of caution to maintain high vigilance against importation of polio. "Until polio is globally eradicated, all countries are at risk and the Region's polio-free status remains fragile. High immunization coverage can prevent an imported virus from finding an underimmunized, susceptible population. A sensitive surveillance system, able to quickly detect and identify any importation and guide a programmatic response, is critical," she added. ]]> <![CDATA[Dell Streamlines Patient Care in India]]> https://biospectrumindia.com/news/95/6208/dell-streamlines-patient-care-in-india.html https://biospectrumindia.com/news/95/6208/dell-streamlines-patient-care-in-india.html Thu, 27 Mar 2014 13:26:00 +0530 Dell Services unveiled a cloud-based solution that seamlessly and cost effectively delivers integrated clinical and financial systems for healthcare providers in India. This is a highly scalable, widely accessible and flexible solution to suit the unique needs of Indian healthcare providers. Targeted at midsized hospitals, large hospital chains and clinic networks, the solution ensures that providers have instant access to uniform workflows and customized reports across entities and geographies. Through a centralized approach, the solution gives healthcare providers the ability to adopt automated workflows and business processes using a single-instance application, reducing operational complexity and dependencies on paper records. This not only prevents manual errors and time delays, but will also enhance decision making and improve the patient experience. With this solution, end-users (physicians, nurses and back office staff) can access cloud-based applications and reports through the use of a simple conventional browser. The solution also allows users to remain connected via smart phones and other hand-held devices, ensuring secure and anytime, anywhere access to information. Commenting on the role of cloud in enabling better healthcare outcomes, Dr. Ashwin Naik, founder and ceo, Vaatsalya, India's first hospital network focused on Tier II and Tier III towns said, "The healthcare industry in India is increasingly turning to IT adoption to improve patient outcomes. As hospitals and providers expand their operations with new referral centers, facilities, and acquisitions in new geographies, the need to access, integrate and connect these disparate systems is gaining importance. Cloud-based technology has the potential to addresses most of the IT-related issues -- access to the right information at the right time and operational efficiency, among others. More importantly it is affordable, scalable and flexible." Dell is collaborating with Ubq Technologies and Ramco Systems to deliver an end-to-end proposition to providers. Ubq's Hospital Information System (HIS) solution, medics, will serve as the front-end application for patient-centric activities and will integrate with Ramco ERP on Cloud to provide customers seamless enterprise-wide application on the cloud. Delivered as a Software-as-a-Service (SaaS) model, the solution allows healthcare providers to quickly respond to increasing demands of infrastructure and storage, and train staff without huge capital investments and recurrent readiness costs. "There is a seismic shift happening in the global healthcare industry. The overarching trend is to integrate and move information to the right person or system at the right time - whether it's a provider's staff, external service provider, or the consumer (patient or prospect),"said Sudhanshu Bhandari, senior analyst, Forrester Research. "The ability to create an information infrastructure that brings together the micro level of personalized health and the macro level of epidemiologic mappings to institutional quality and evidence-based practices will be a key differentiator for healthcare providers in future. Cloud-based end-to-end business services would help healthcare companies jump start these business initiatives and collaborate with global peer institutions. However, the Indian healthcare market is still very cost competitive and more maturity is needed to effectively leverage cloud-based solutions." "We are extending Dell's proven capabilities and global healthcare leadership to India and have brought in the best-of-breed combination of HIS and ERP to help providers achieve their goal of providing efficient, information-driven healthcare in an affordable way. We will continue to bring to India unique solutions that will allow healthcare providers to focus on their number one goal-- enhanced patient care," said Sid Nair, vice president and global general manager, Healthcare & Life Sciences, Dell Services. "The solution is truly one of a kind in terms of its capabilities, delivery model and pricing. We believe that this will be a game changer for the Indian healthcare industry, where hospitals are constrained by huge upfront capital investments, and higher cost of licensing, maintenance and support." This solution is available today in India and is an integral part of Dell's vision of building future-ready IT platforms to provide cutting-edge technology and services that enable innovation in Health IT. The cloud-based solution also extends Dell's Cloud strategy of providing choice and flexibility to customers to drive tangible business results through cloud computing. ]]> <![CDATA[Syngenta launches 'The Good Growth Plan']]> https://biospectrumindia.com/news/95/3742/syngenta-launches-the-good-growth-plan.html https://biospectrumindia.com/news/95/3742/syngenta-launches-the-good-growth-plan.html Thu, 27 Mar 2014 13:09:00 +0530 Syngenta recently announced six commitments to address the global food security challenge. The Good Growth Plan has specific, ambitious and measurable targets which focus on boosting resource efficiency, rejuvenating ecosystems and strengthening rural communities.This new initiative aims to address the challenges we face with respect to scarcity of natural resources that will increase the existing pressure on farmers who are working to meet the world's needs for food, fuel and fiber and define food production in the coming decade. According to Kanupriya Saigal, Manager Corporate Affairs- External Communication and Branding- South Asia and Seetharam Annadana, Traits Development Lead, South Asia, "We know that agriculture is the mainstay of the economy in South Asia and will continue to be for at least the next few decades providing employment to almost 60 percent of the population. Coupled with this, the biggest challenge of the 21st century would be to feed more mouths demanding improved nutrition in a sustainable manner. With South Asia estimated to add more than half a billion people by 2050, the farmers will have to grow crops more efficiently, conserve existing land, improve biodiversity and most importantly integrate the vast multitude of smallholders currently holding less than two hectares into the mainstream of the developmental process." They go on explaining the details about the commtments and the plan as under: --Make crops more efficient: Increase average productivity of the world's major crops by 20 percent without using more land, water or inputs --Rescue more farmland: Improve the fertility of 10 million hectares of farmland on the brink of degradation --Help biodiversity flourish: Enhance biodiversity on 5 million hectares of farmland --Empower smallholders: Reach 20 million smallholders and enable them to increase productivity by 50 percent --Help people stay safe: Train 20 million farm workers on labor safety, especially in developing countries --Look after every worker: Strive for fair labor conditions throughout our entire supply chain network Per hectare productivity is low in South Asia compared to other regions. 98 percent of the available agricultural land is already under cultivation and more than 80 percent of the increase in production will have to come from yield increases. For ensuring nutritional security, it is not only important to increase per capita availability of foodgrains but also to ensure the right amounts of food items in the food basket of the common man.Poor water management in many countries of Asia has resulted in land degradation in irrigated areas through salinization and waterlogging. This can cause yield decreases of 10 to 25 percent for many crops and may prevent cropping altogether when it is severe. It is estimated that 3 percent of the world's agricultural land is affected. In South Asia the proportion is however 8 percent. Agriculture in South Asia is dominated by small farmers. If we take the example of India, Landholdings declined from 2.30ha in 70s to 1.32 ha in 2000-01 and if this continues...average size would be a mere 0.68 ha in 2020 and 0.32 ha in 2030. Currently 86 percent of Indian growers have landholdings of less than two hectare but cultivate 44 percent of the farmland and their contribution to farm output exceeds 50 percent. Smallholders present a huge potential for productivity enhancement. Thus all the challenges focused on in the Good Growth Plan are relevant to South Asia. This is why the project is crucial for our territory. We already have several examples in South Asia that reflect some aspects of the Good Growth Plan. We are making crops more efficient and also helping in empowering smallholders through our TegraTM riceoffer in India and Bangladesh.TegraTM first piloted in South India in 2009 and is an integrated rice growing system resulting in yield increase of up to 30%, improving grain quality by 7% and more importantly saving almost 28 days of labor. Tegra enables growers to outsource seedling production, addresses the key challenges of labor scarcity and provides education to increase productivity. In 2012, 4000 farmers had adopted Tegra and is expected to grow exponentially by several fold in 2013. Another initiative is GroMore to make crops more efficient and empower smallholders in South Asia. Thisis also an integrated solution for rice comprising simple protocols offering timely advice 'in the language of the farmer' to establish and protect the crop, delivering immediate yield increases of up to 30%. Project Nirmiti in Odisha India is another program that aims to empower small farm holders and utilizes a network of local residents to make agricultural knowledge, inputs and services available to smallholders in rural India to improve farming practices, productivity and livelihoods. The project focuses primarily on rice and brings together agricultural companies, enterprising individuals and new technologies to improve farmers' lives. So far 45 entrepreneurs have been appointed to cover around 700 villages. Around 8000 smallholder farmers have already been registered on the program. Techno-Commercial Centers in Madhya Pradesh India is one more example aimed at empowering smallholders. Farmer Producer Companies (FPCs) formed by the government with an aim to help India's smallholders access technology and achieve economies of scale in purchasing, marketing and other key areas. The Syngenta Food Security Agenda team is supporting the government of Madhya Pradesh State in the restructuring of three FPCs. The commitment to look after every worker is clearly reflected in the Syngenta Me and Mine program in India. Our work to address the problem of child labor and overall working conditions in agriculture in a proactive and comprehensive way started in 2003 through a global partnership with the Fair Labor Association (FLA). Syngenta was the first agriculture based company to do so. Syngenta launched an India-wide program called 'Syngenta Me & Mine' in August 2009 to build tangible and practical commitments from vegetable seed growers so they had a sense of ownership in the outcomes for their families and communities. It has reached 22.5 thousand growers and their families. The program has monitored nearly 47 thousand seed production farms, covering around 2.10 lakh farm workers. Syngenta is committed to product stewardship to ensure our products are used as safely as possible throughout their lifecycle from design to disposal.In 2012 through our extensive efforts in India Syngenta equipped more than 1 million growers and 1850 channel partners with knowledge on Safe Use and Handling of Crop Protection products through 17,000 farmer meetings/demonstrations. Extensive research has revealed a widespread societal view that farming needs to become more responsible. While governments are seen as primarily accountable for ensuring reliable food availability, Syngenta believes it is incumbent on business to play a larger role in fostering a long term approach to food security. This means using our substantial investment in R&D to advance technologies that not only protect but also enhance the environment and benefit rural communities. ]]> <![CDATA[Life expectancy of HIV patients in India increased]]> https://biospectrumindia.com/news/95/3247/life-expectancy-of-hiv-patients-in-india-increased.html https://biospectrumindia.com/news/95/3247/life-expectancy-of-hiv-patients-in-india-increased.html Thu, 27 Mar 2014 13:05:22 +0530 Close to 700 participants from across the globe assembled to deliberate upon actionable strategies for fighting the global HIV epidemic, in the 3-day long HIV Congress 2014, held in Mumbai. Speaking on the occasion, Dr. J.K. Maniar, organising chairperson, HIV Congress 2014 commented, "The global scenario of HIV is changing day by day. Until twenty years ago, there was a huge amount of social stigma associated with HIV- patients were sceptical to consult doctors and even doctors had limited knowledge. Earlier, a patient had to consume 20-25 pills a day to survive, and still had to bear numerous side effects, along with high costs of the medicines. A lot of deaths were due to lack of early detection of the disease and the side-effects of the available drugs." He further added, "Today, HIV has transformed into a chronic, controllable and easily manageable disease. Due to increased levels of awareness, patients seek early consultation and treatment, which automatically improves the prospects of a healthier life. Currently, a patient has to take only a single pill, with no accompanying side-effects, and at an affordable cost." "Rolled out in 2004, National ART program has evolved from 8 ART centres to network of 1280 ART service delivery points wherein 7.5 lac patients are receiving free ART. This has changed the outlook of HIV from a death sentence to chronic manageable disease. Recently NACO has also decided to introduce 3 rd line ART in addition to 1 st and 2 nd line ART," said Dr. B.B. Rewari, national programme officer (ART) WHO/NACO. A recent initiative has been to provide multi drug ART to all positive pregnant women to ensure that no child is born with HIV. HIV, once considered a catastrophic infection, is no more life threatening today. The credit goes to ongoing worldwide research in this area, new drugs and initiatives to raise awareness about HIV and its management. Mr. Oussama Tawil, UNAIDS coordinator, India said, "An HIV patient in India can now live a healthier life with an almost normal life expectancy. The Department of AIDS Control along with private practitioners is currently expanding access to treatment and working with civil society organization to ensure continuum of care. Scientists continue to challenge themselves by exploring newer molecules with even lesser side effects and also drug delivery systems that reduce doses." Mr Khanna added, "Indian pharma industry has contributed to global ARV medicine requirements with generic version at affordable price. This has helped various government and procurement agencies reach out HIV medicines in access programmes towards making 15 by 15 access a reality." The focus of the HIV Congress 2014 was to disseminate and share knowledge about HIV amongst clinicians, to enable them to devise more effective disease management methods, encourage young physicians to take up HIV as a speciality, and bridge the gap between private HIV physicians and government bodies like Department of AIDS control (DAC), WHO and UNAIDS, in turn encouraging collaborative research on HIV in India. According to the Department of AIDS Control (India) as of the year 2012, an estimated 20.3 lacs people are living with HIV. The number of new infections has come down by 57% to 1.1 lac per year due to increased awareness and wider availability of free ART. With modern HIV treatment, doctors are hopeful that many HIV Positive people would be able to live as long as their HIV Negative peers. A lot of effort is being put into making the HIV treatment more accessible to everyone who needs it. Without treatment, people with HIV will almost always eventually become severely ill, and their lives would be shortened. ]]> <![CDATA[FOGSI announces national program to improve women and maternal health in India]]> https://biospectrumindia.com/news/95/5368/fogsi-announces-national-program-to-improve-women-and-maternal-health-in-india.html https://biospectrumindia.com/news/95/5368/fogsi-announces-national-program-to-improve-women-and-maternal-health-in-india.html Thu, 27 Mar 2014 12:57:31 +0530 With the aim of helping India achieve the Millennium Development Goal on reducing maternal mortality rate by 2015, The Federation of Obstetric & Gynaecological Societies of India (FOGSI), the apex body for all Obstetricians & Gynaecologists in the country has launched the theme for the year 2014 "Empower Women Empower India - Pledge for Excellence". In this they are looking at "Women Empowerment through the lens of Health awareness, access and affordability". FOGSI in partnership with the Government of India, NGOS and educational grants from corporates will roll-out a host of initiatives covering various stakeholders in urban and rural areas across India to address women and maternal health issues. To mark the onset of the program, Dr. Suchitra N. Pandit, president, FOGSI felicitated women achievers from different walks of life who have contributed towards the society and made a mark for themselves. Some of the key achievers were Ms. Neeti Mohan, singer, Mrs. Jyoti Tanna, founder Each one Teach One, Ms. Suhita Thatte ,Actor, Dr. Armida Fernandez, social paediatrics & founder trustee - Sneha, Mrs. Vandana Krishna director general, RJMC Health and Nutrition Mission, Government of Maharashtra and so on. Announcing the theme, Dr. Pandit said, "Maternal mortality is one of the basic health indicators of a society. It is a benchmark of humanity. Although MMR is showing a reducing trend yet we have a long way to go. FOGSI will work in collaboration with the Government of India and various stakeholders and reach out to the interiors of India including the tribal areas where there is an unmet need for contraception, comprehensive abortion care, adolescent reproductive health, mother and child care and menopausal health." "We will be also addressing issues related to female sexual health and formulate strategies to reduce the burden of Cervical Cancer in India. FOGSI will continue to play a major role in implementing policies in various aspects of maternal and child health and will collaborate and partner as far as knowledge sharing is concerned", she further added. The initiatives that will drive the theme "Empower Women, Empower India - Pledge for Excellence" this year are:- Sensitization program for women, husbands and mothers-in-law in rural areas on pre-natal healthcare, reproductive health, avoidance of discrimination and violence, issues of sexuality, understanding of joint responsibilities etc. - FOGSI Youth Mela for empowering the future generation of India by creating awareness on staying fit and healthy, importance of contraception, prevention of HIV/sexually transmitted infections and cervical cancer by vaccination, self-defence and first aid - Advocacy and education program for doctors on skills upgradation and knowledge and focused workshops for training and capacity building of maternity care providers - FOGSI anti-obesity drive for creating awareness regarding lifestyle changes, healthy diet, exercise and pharmacotherapy when required - FOGSI Medical college initiative for promoting awareness and prevention of Cervical Cancer and promoting reproductive health "Women in India continue to die due to hemorrhage at child birth, low awareness and lack of access to suitable health infrastructure and resources", says Dr. Nozer Sheriar, secretary general, FOGSI. The state of India's healthcare is at a very critical stage which relies on private medical care without the availability of public health services. Also, the patients and their families lack adequate healthcare knowledge which adds to the problem. Considering this, we have tailored our initiatives to address these huge problems. Currently maternity and newborn package is not covered by most existing insurance companies and this year FOGSI will attempt to facilitate medical insurance for pregnancy coverage." ]]> <![CDATA[Healthcare industry leaders outline vision for future of healthcare]]> https://biospectrumindia.com/news/95/3729/healthcare-industry-leaders-outline-vision-for-future-of-healthcare.html https://biospectrumindia.com/news/95/3729/healthcare-industry-leaders-outline-vision-for-future-of-healthcare.html Thu, 27 Mar 2014 12:56:13 +0530 Captains of India's healthcare industry, including Dr Devi Shetty, Dr Naresh Trehan, and Shivinder Mohan Singh came together on a common platform in the city recently to share their vision of the future. The doyens of India's health sector talked on key issues plaguing India's healthcare industry, including the lack of manpower and policy and regulatory issues as well as the need for greater integration of modern and traditional systems of medicine, better use of technology and the need to upgrade skillsets to ensure a better healthcare system for the 21st century. Calling for major changes in the existing health system, Dr Naresh Trehan, CMD, Global Health (Medicity), said: "Healthcare is basically disease management. We should build our system from the ground up to create a new blue-print of India's healthcare. We have over 800,000 ASHAs (Accredited Social Healthcare Activists) in India, but they are ill trained and don't have any medical skills. Their costs are a huge burden on the exchequer and nothing gets accomplished in return. All we have to do is to upscale their skills so that they can be the eyes and ears of the healthcare system on the ground. They need to monitor hygiene and find out who in the community needs medical assistance. This will be a big help in ensuring quick diagnosis of diseases and reducing the incidence of NCDs." Talking about the acute shortage of medical specialists in the country, Dr. Devi Shetty, Founder & Chairman, Narayana Health, pointed out that while the US has 19,000 undergraduate medical seats and 32,000 PG seats, in India it is the opposite - the country has close to 50,000 undergraduate medical seats but only 14,000 PG seats. "The low number of PG seats results in a shortage of specialists. This can have terrible consequences on the ground. For example, India has one of the highest maternal mortality rates in the world and this is unrelated to the amount of money we spend on healthcare. The reason is that we have created a regulatory structure where only a specialist can perform certain tasks, and the country simply doesn't produce enough of these specialists," he said. Dr Shetty suggested that to tide over the problem, the country needs medical educational institutions on the line of the College of Physicians and Surgeons (CPS) in Maharashtra which would offer diploma courses in fields like anesthesia, gynecology, and pediatrics to medical graduates. "This can convert the entire 50,000 medical graduates produced in India every year into specialists who can then help reduce maternal mortality in India," he added. "If we want to deliver better healthcare outcomes, India doesn't require money. We only require policy changes. This will not happen till the Government looks at medical education as integral part of the country's development." Dr Shetty also expressed concern about the nursing profession in India, which he said would die down in a few years if urgent measures are not taken. "There is zero career progression for nurses. Nursing is now considered a dead-end career. Admissions to nursery colleges in India have come down by 50%. Half of the nursing colleges in Karnataka have shut shop. In the years ahead, there will be an acute shortage of nurses in the country. There is a critical need to empower nurses by offering them a path to upgrade their skills and become specialists. About 67% of anesthesia in the US is given by nurse anesthetists. In India, we don't allow a nurse who has worked in critical care for 20 years to even prescribe a Paracetamol tablet!" he said. Dr Devi Shetty highlighted the need to look for alternative ways of funding healthcare, such as by a surcharge on mobile phone bills, bring down the cost of building hospitals, develop patient management software, and establish one or two health cities with 3,000 to 5,000 beds in each metro where cutting-edge work can be done. Outlining his views on the role of technology in ensuring greater access to quality healthcare, Shivinder Mohan Singh, Executive Vice Chairman, Fortis Healthcare, said, "Technology has played a vital role in healthcare in the last 30 to 40 years, whether it is diagnosis or treatment. Going forward It is going to trigger more changes in healthcare than any other factor. Healthcare access will get radically transformed with technology whether it is in terms of proximity through devices planted in our bodies or by low-cost healthcare using innovative technological solutions or the speed with which information is shared." Singh added, "A healthcare ecosystem would be created in future where different silos begin to talk to each other about patients and exchange information. Healthcare delivery is going to become more personalized in terms of tailor-made treatments for an individual." Talking about the need for better integration of different systems of medicine, Singh said: "Allopathy has taken a predominant share of the existing market in healthcare, but I think we can't avoid for too long the benefits that other health sciences bring to the table. Some kind of integration of different health disciplines is bound to happen in future." He also emphasized that the onus of taking charge of one's health has to rest on the individual. "We need to be more concerned for what we do to our health rather than what healthcare would do to us. We need to take ownership of our own bodies and mind and not outsource these to healthcare providers. People need to focus more on preventive care rather than just landing in sick care - this is going to the mantra of healthcare in future," he said. "The Future of Healthcare: A Collective Vision" was the first-of-its kind global healthcare conference that was held in Delhi in March 3-4. With participation from over 15 countries and the presence of more than 500 delegates, the two-day event, hosted by The Healthcare Alliance, saw an impressive turnout of thought leaders, policy makers, senior Government officials, and business and health leaders from India and across the globe. ]]> <![CDATA[Western models have failed, India requires its own : Sam Pitroda]]> https://biospectrumindia.com/news/95/5967/western-models-have-failed-india-requires-its-own-sam-pitroda.html https://biospectrumindia.com/news/95/5967/western-models-have-failed-india-requires-its-own-sam-pitroda.html Wed, 26 Mar 2014 11:00:00 +0530 Speaking recently at the second foundation day celebrations of Biotechnology Industry Research Assistance Council (BIRAC), Dr Sam Pitroda remarked, "The western models are no longer scalable. We need to create new models of our own. That is where the innovation comes into the picture. That is why the government had made the decade 2020 as the decade of innovation." "There is the need of excellence in research areas which have been lagging in the quality. Hospitals have not been upto the mark. Accessibility is another area where a lot of work is required," added Dr Pitroda who is also the prime minister, Dr Manmohan Singh's chief advisor on innovation. Explaining the work of UPA government, he mentioned, "We have created state level innovation councils to focus on innovation. After three years of bickerings, scientists, bureaucary, workers came together to find the priority areas from the state. Idea is to get 2,000 to 3,000 people. Inclusive innovation is the key term." The innovation happening in the labs may not be enough for that. Glad that the BIRAC started this journey. Clusters, scholarships and much more . 30-40 billion in biotech as an investment is important. It is possible to see biotech as 200 billion industry in the next decade. It is feasible if we focus. Hope is from the technology that offers opportunity areas across . The old generation must move out to pave way for new ideas to come, he concluded. Dr K Vijay Raghavan, secretary, department of biotechnology (DBT),who was present on the occasion, mentioned, "From 20 million to 6.6 million child deaths, there has been a decrease. But the fact is that children less than 5 years of age die every year. Forging novel partnerships in sync with the BIRAC. What we require is the ecology for the translation. Critical question is if the research is creating enough knowledge." Former secretary, DBT, Dr M K Bhan in his speech emphasized that the balance of values is a must and that the BIRAC will adopt the persistence as its policy."Moral strength and technical competence to achieve and make India pride. System allows for failure and that allows huge opportunity for BIRAC. Anybody can be Tata Ambani and challenge is small stakeholders whose voice is heard." ]]> <![CDATA[Modi endorses technology in agriculture, balanced view on GM]]> https://biospectrumindia.com/news/95/4581/modi-endorses-technology-in-agriculture-balanced-view-on-gm.html https://biospectrumindia.com/news/95/4581/modi-endorses-technology-in-agriculture-balanced-view-on-gm.html Wed, 26 Mar 2014 09:54:00 +0530 As the election campaign unfolds, the churning of less discussed ideas and opinions too becomes a part of public deliberations. During his Chai pe Charcha event with farmers a village in Maharashtra's Yavatmal district, Mr Narendra Modi on March 20th was asked about his views on allowing GM crops to be cultivated in India. The Bharatiya Janta Party's (BJP) prime ministerial candidate who is tipped to head the next government, seemed to be in favor of allowing the technological interventions in agriculture. "There were different opinions on GM technology. But Bt cotton immensely benefited farmers in Gujarat and even in some parts of Maharashtra. I am all for technology. We should not discard a technology that helps farmers; we must have faith in science. We must put technology and science to use, with regulations, and add value to produce,"Mr Modi remarked. This might sound interestingly optimistic to the industry but the road ahead still is not without contradictions as the difference of opinion seems to be emerging in the party over this issue. Earlier on March 9th, a group of close to 55 agriculture scientists, activists and groups opposing GM crops met Dr Murli Manohar Joshi, head of manifesto committee and argued against the crops. Dr Joshi reportedly assured them that the crops won't be allowed without rigorous biosafety assessment. Meanwhile, high on leftist activism, Aam Aadmi Party has come out openly againt the use of the technology. "On the one hand, scientific evidence and scientists voices on the adverse impacts of GM crops to human health and environment are increasing, and on the other experiences with BT cotton also show that the only entity that is benefiting from the introduction of GM crops are the big seed corporations which get monopolistic control over our seed sector," mentions the party's blog. In this season of election euphoria, wait and watch seems to be the best course as of now. ]]> <![CDATA[ERBA ups its product portfolio at ARAB Health 2014]]> https://biospectrumindia.com/news/95/3728/erba-ups-its-product-portfolio-at-arab-health-2014.html https://biospectrumindia.com/news/95/3728/erba-ups-its-product-portfolio-at-arab-health-2014.html Tue, 25 Mar 2014 14:54:52 +0530 The ERBA Group of Companies has spread its wings across the globe and is today recognized as one of the most reputed organizations offering quality diagnostic solutions. Innovative products, ably supported by an excellent after sales service, has made ERBA a trusted partner for innumerable healthcare professionals throughout the world. Transasia Bio-Medicals Ltd. is a subsidiary of the global ERBA Group of companies. The Arab Health Exhibition and Congress offers a global platform for the confluence of some of the best names in the industry. This year Arab Health was held in January 2014 at the Dubai International Convention and Exhibition Centre. More than 3900 exhibitors and representatives from over 153 countries made the convention a grand success. ERBA has been an active part of the exhibition for ten years. This year too, the ERBA Group showcased some of its latest and best technologies in the field of Clinical Chemistry, Hematology, Critical Care, Diabetes, Immunology, Urine Analysis, Hemostasis and Microbiology. The key highlight at the event was the launch of ERBA's latest biochemistry analyzer XL 180 and diabetes management analyzer Hb Vario. The ERBA Group was well represented by Suresh Vazirani, chairman & managing director and the team from ERBA Group. More than 1000 people including reputed pathologists, microbiologists, diabetologists & hematologists from all over the world, visited the ERBA stall. Some of the famous names include the Ministry Of Health (MOH) team from UAE, Saudi Arabia, Kuwait & Oman. They highly appreciated ERBA Group's technical expertise. ]]> <![CDATA["Revisiting Healthcare Policy"]]> https://biospectrumindia.com/features/95/3726/revisiting-healthcare-policy.html https://biospectrumindia.com/features/95/3726/revisiting-healthcare-policy.html Tue, 25 Mar 2014 11:44:00 +0530 The common objectives behind all types of life sciences research are to ensure the health of an individual. Be it the pharmaceuticals, medical technology, biotechnology, agriculture or any other field, the motto is to develop affordable quality product that benefits the people at community at large. Therefore, to ensure the best outcome from the public research, we need some well planned accurate policy decisions. Similarly the awareness and prevention programmes too have to be packaged in a way so that there is broader outreach. However, there is a big question mark over the ability to so do in a huge complex populous country like India. The implementation here is not just linked to the availability of funds or resources but the state-centre relationships and programme overlaps. Where do we stand? Experts agree that the access to healthcare facilities in India has somewhat not been upto the mark so far. This belief is fully backed by the reports like FICCI HEAL 2013 which mentions that India constitutes 17% of world population, 20% of global disease burden but spends only 1% of global healthcare expenditure. The out of pocket expenditure on healthcare is about 65% and only 10% of Indian population receives healthcare subsidies. According to Mr Lov Verma, secretary of health, ministry of health and family welfare, "The 29.8% of population is below the poverty line, 43% don't have access to healthcare facilities amd 49% have no drainage facility. The healthcare percentage to the overall GDP in Feb, 2014 stood at 3.7 % and there has been increase in the healthcare spending from 22% in 2005 to 21% in 2011." The planning commission chairman, Dr Montek Singh Ahluwalia is of the opinion that curative healthcare is a responsibility. "Unless you cross the road, you don't feel the stones. As we evolve our health policy, we have to consider all the options. Next ten years have to be seen as delivery of curative healthcare services that will lead to visibility." Putting more onus of implementation on the states, he says, "Actual management of health is a state responsibility and they have to be more proactive. Health ministry received so many proposals from the states. If there are more imaginative ways of doing it, those are welcome." Touching the subject of distrust between the NGOs and medical practitioners," Dr Ahluwalia feels that the overall differences in pharma industry require to be resolved on priority. "These are not going to just disappear. Sensible approach required to these issues," he says. The planning commission member, Ms Syeda Hamid has no qualms in accepting that India as a nation has failed to fulfil the health requirements. She feels it is not only the job of government but all the stakeholders. She says, "There are humanitarian values where for its sake, the doctors have left their jobs to serve in rural areas. But not all follow this example." However, on criticism of planning commission on the issue, she says that blaming it for the implementation is not right as we made a beginning somewhere. The tussle between communicable and non communicable diseases is also an issue to be addressed. Prof. K Srinath Reddy, president, Public Health Foundation of India (PHFI) disagrees with the claims that NCDs are not being paid an attention. He cites the m-health projects in Andhra Pradesh, Haryana and Himachal Pardesh and mentions, "Recognizing the diversity in different states and their varied promotion, we cannot say NCDs have not been paid full attention." Former director general, Indian Council for Medical Research (ICMR) and eminent scientist, Dr N K Ganguly feels that there should have been no dissection between the NCDs and communicable diseases in first place." Creating ecosystem Healthcare being a part of society, experts also feel that there is a need to incorporate the health policies in employment and jobs. Besides that innovation and building on whatever has been achieved so far would help move further in right direction. There is a strong need to develop an enabling ecosystem for facilitating healthcare innovation with active participation from industry, academia and the government. The quantum of funding for R&D has to be increased manifold and the regulatory framework should facilitate indigenous development of medical technologies. Dr Pratap Reddy, chairman, Apollo asks that if government can allow the hugely funded space programmes to Mars and moon, why can't the healthcare as it deals with the people directly? "We should wake up now and pay it the due attention," he said. Stressing on the role of technology, Mr Anjan Bose, secretary general, Healthcare Federation of India (NATHEALTH) has evolved in many areas of medicine and emerged as one of the strongest pillars of modern healthcare. He says, "The next big technology revolution is going to come in the symbiotic marriage between IT and healthcare. This offers tremendous possibilities, considering the deliverables from all-pervasive mobile telephony, cloud computing, analytics and so many other areas where the already available technology can be used to make quality healthcare more accessible in an affordable manner. This will also help in addressing the skill gaps that exist in every segment in Indian healthcare today." Multi-Stakeholder Action Affordability is the main culprit as the reach ability to the large populations. From diagnostics to treatment, government is seeking the cooperation from the private sector. Mr Karan Singh, partner, Bain and Company, says, "The root cause drivers for the implementation of important healthcare programmes are policy, awareness, access, portability and role of technology. All of these will ensure the healthcare delivery. But doing it alone is a recipe of disaster. Therefore, apart from looking at treatments, government must focus on getting the all the stakeholders together to create a multi-faceted solution." On a positive note, Mr Lov Verma points towards the substantive increase in the healthcare expenditure over the period of time. "Government seeks to address the discrepancies in the facilities and is now turning more towards public private partnerships (PPPs). As an example during the last plan, there was just one cancer centre and now we have seventy one at the closing of plan." Many believe that whatsoever may be the goals, without the activists pushing it hard, nothing moves on ground actually. As Ms Sayeda Hameed mentions, "Irrespective of the political party at the centre, the plan for 2017 has been defined. So the goals too are set and now the pressure mechanism has to work." India's roadmap to an effective healthcare mechanism on ground will require three ingredients: partnerships, maximum utilization of resources and continuous feedback. Next one decade can prove crucial for the country to evolve itself to compete at a global scale. Need Action? â– Increased health spend.â– Regular screening and creation of personal health records.â– Develop affordable technologies.â– Improve medical education system. â– Bride gap between public and private healthcare ]]> <![CDATA[DBT, Gates Foundation push agriculture research projects focused on nutrition ]]> https://biospectrumindia.com/news/95/3725/dbt-gates-foundation-push-agriculture-research-projects-focused-on-nutrition-.html https://biospectrumindia.com/news/95/3725/dbt-gates-foundation-push-agriculture-research-projects-focused-on-nutrition-.html Tue, 25 Mar 2014 11:22:00 +0530 The Department of Biotechnology (DBT), Ministry of Science and Technology of India, and the Bill & Melinda Gates Foundation launched Grand Challenges India (GCI) on March 20, 2013 in New DelhiBiotechnology Research Assistance Council (BIRAC) as the implementing agency for the Grand Challenges framework has announced the first initiative under Grand Challenges India, program titled "Achieving Healthy Growth through Agriculture and Nutrition" with funding support from DBT, USAID, and the Gates Foundation. Achieving healthy growth through agriculture and nutrition seeks to target the relationship between agriculture, nutrition, and health to reduce the high incidence of low birth weight and early stunting and wasting among India infants. Following an extensive review process by committees consisting of national and international experts, the awardees have been announced today by Prof K Vijay Raghavan, secretary DBT and chairman, BIRAC. The five selected proposals focus on achieving development of innovative interventions that integrate agriculture practices with nutrition outcomes aimed at improved health benefits for woman and children for significant socio-economic impact and include two Interventional Development Grants and three Seed Grants. The details of proposals are mentioned below: 1. Digital Green in collaboration with Voluntary Association for Rural Reconstruction and Appropriate Technology (VARRAT), London School of Hygiene and Tropical Medicine (LSHTM), The Strengthening Partnerships, Results and Innovations in Nutrition Globally (SPRING), Tata-Cornell Agriculture & Nutrition Initiative (TCI), Development Corner (DCOR): Digital technology enabled and community driven integrated agriculture and nutrition intervention to promote maternal and child nutrition in Odisha. This is an interventional development grant. 2.Annamalai University in collaboration with The International Rice Research Institute, New Delhi: Designing on-farm participatory models of integrated farming system for enhancement of household diet diversity and livelihood of women small holder farmers. This is an interventional development grant. 3.EKutir Rural Management Services Private Limited in collaboration with Wholesome Wave, McGill Center for Convergence of Health and Economics: Veggie Lite - Conjunction of agriculture, nutrition and health for inclusive development of women. This is a seed grant. 4. Science for Society, Mumbai: To ensure year wise nutritional food security for Indian women through community level implementation of Domestic Solar Conduction Dryer. This is a seed grant. 5.Amity University, Noida: Novel approach to reduce zinc malnutrition in rural women and children through agronomic bio-fortification of food crops. This is a seed grant. "We continue to seek new ways to integrate our programs targeting healthy birth, growth, and development to maximize impact" said Chris Wilson, Director of Discovery & Translational Sciences at the Bill & Melinda Gates Foundation. "We are excited to learn from our Grand Challenges India partnership and to explore new ways to link agriculture and nutrition to achieve healthy growth for babies." Prof. K. Vijay Raghavan, Secretary, DBT & Chairman BIRAC stated that "Biotech science is unusually placed today to have a transformative impact on saving lives and improving health through agri-nutrition. We are determined to do our best and not let slip this opportunity for our people." ]]> <![CDATA[IDRI and Jubilant extend research for TB drug discovery ]]> https://biospectrumindia.com/news/95/3440/idri-and-jubilant-extend-research-for-tb-drug-discovery-.html https://biospectrumindia.com/news/95/3440/idri-and-jubilant-extend-research-for-tb-drug-discovery-.html Tue, 25 Mar 2014 10:39:00 +0530 Jubilant Chemsys, a wholly-owned subsidiary of Jubilant Life Sciences, and one of the most recognized drug discovery research services organizations from Asia on March 24,2014 announced an extension of collaborative partnership with Infectious Disease Research Institute (IDRI) for TB drug discovery. Today marks World TB Day, designated to build public awareness of the disease. Jubilant Chemsys offers drug discovery research services on Full Time Equivalent and Fees- for-services basis. The collaboration in chemistry support has been in existence since 2009 as part of a joint effort with the Lilly TB Drug Discovery Initiative (LTI) and so far has generated hundreds of Novel Chemical Entities (NCEs) - some of which have now been identified for further exploration. Jubilant Chemsys, under the terms of agreement, so far had been offering philanthropic support and expertise in synthesis of NCEs to support the early research in TB. Commenting on the collaboration, Dr. Subir Basak, President, Jubilant Drug Discovery Services "Jubilant is excited to extend the partnership with IDRI in identifying and discovering novel chemical entities in the area of tuberculosis. We are glad that the collaboration is leveraging our chemistry talent and our experience in anti-bacterial research. The research outcome will address the current unmet medical need in the field of TB therapy - a growing concern in under developed and developing economies including India." "We have been impressed with the commitment and engagement from Jubilant Chemsys in support of TB drug discovery over the past few years. We are excited to expand our efforts with them to access additional synthetic and medicinal chemistry capabilities. This will take us another step closer to our goal of developing much-needed new drugs to combat tuberculosis." Tanya Parish, Ph.D., IDRI, Vice President of Drug Discovery. IDRI is a founding member of both the LTI and the TB Drug Accelerator, a unique partnership funded by the Bill & Melinda Gates Foundation that targets the discovery of new TB drugs by collaborating on early-stage research. The Foundation recently awarded IDRI $3.4 million in additional funding to Tanya Parish, Ph.D., IDRI Vice President of Drug Discovery, and supplements an earlier grant awarded in 2010, for a total of $7.8 million. The grant is focused on identifying new leads and drug targets for tuberculosis with the ultimate goal of producing new drugs to treat TB. "Jubilant has been extremely successful in advancing several validated hit series for the Lilly Initiative, and we are very pleased to see this progress recognized through the ability to expand the Jubilant collaboration with IDRI. We are very grateful to Jubilant for all they have done to get us to this point, and look forward to reaching our goals through this expanded partnership." Dr. Philip Hipskind, Ph.D., Lilly, Distinguished Research Fellow and Leader of the Lilly Initiative. With this association, Jubilant will continue to provide chemistry and medicinal chemistry support to IDRI. The company is also evaluating further liaisoning with IDRI in key functional areas like computational chemistry and Drug Metabolism and Pharmacokinetics (DMPK) Services. Mycobacterium tuberculosis is the causative agent of human tuberculosis, a devastating infectious disease that kills about 1.5 million and infects more than eight million people each year. There is an increasing threat from multi-drug resistant and extremely drug resistant strains, demonstrating the need to develop more effective, cheaper and faster-acting drugs - the prime focus of IDRI's Discovery Program, led by Parish. About Jubilant Chemsys Limited:Jubilant Chemsys Limited, is a wholly owned subsidiary of Jubilant Life Sciences Ltd. The Company offers drug discovery research services to the various research groups based out of US, Europe and Japan on Full Time Equivalent and Fees-for-services basis. Services offered include Discovery Chemistry services spanning the early phase of drug discovery from concept to candidate selection stage, Medicinal chemistry services include Hit-to-Lead and Lead Optimization, process development and optimization etc., ranging from mg to kg scale. ]]> <![CDATA[Day long awareness campaign on world TB day at AIIMS ]]> https://biospectrumindia.com/news/95/4968/day-long-awareness-campaign-on-world-tb-day-at-aiims-.html https://biospectrumindia.com/news/95/4968/day-long-awareness-campaign-on-world-tb-day-at-aiims-.html Tue, 25 Mar 2014 10:34:00 +0530 Hundreds of students took part in the formation of a human chain and rally to express solidarity with TB patients to raise public awareness about the debilitating disease at All India Institute of Medical Sciences (AIIMS) in association with Becton, Dickinson & Co. (BD India), a leading medical technology company on the occasion of World TB Day. The rally was flagged off by Dr M C Misra, Director of AIIMS and witnessed teachers and students from Dayal Singh College (DU) and NDMC schools holding banners and posters in their hands informing locals about the seriousness of TB and its prevention methods. Participants raised slogans urging people to be mindful about spitting habits and seeking diagnosis if cough persists for more than two weeks. Speaking on World TB Day Awareness programme Prof Sarman Singh, Faculty-in-charge, Microbiology, Department of Laboratory Medicine, AIIMS said, "Tuberculosis has inflicted much misery in terms of suffering and morbidity in the past but wherever we have taken strong and proven measures, the number of people falling ill with the dreaded disease has declined remarkably. Government of India should generate its own data reading efficacy of various diagnostic tests, as some of the recently introduced molecular methods have shown poor performance in detecting the drug resistance. GeneXpert has been a revolutionary diagnostic method in Africa but in India it can miss as many as 1/3 of Rifampicin resistance cases. If such systems are used routinely, this would give a false impression that India has very low rifampicin resistance thus making the programme managers complacent." As part of a daylong activity, students also participated in quiz competition and skit on the disease. Dr. V.M. Katoch, Secretary, Govt of India & DG, ICMR, gave away prizes for the best slogans, skit, quiz and certificates of participation. In addition, a day-long symposium was organized in AIIMS auditorium that was attended by many doctors. Several topics on diagnosis, challenges in pediatric, pulmonary and extra pulmonary TB, evolution of Mycobacterium Tuberculosis driving drug resistance and challenges in TB control were discussed by eminent speakers such as Dr Urvashi Singh, Additional Prof, Microbiology - AIIMS, Dr Ranjani Ramachandran WHO SEARO, Dr Rohit Sarin, Director-National Instt of TB & Resp diseases, Dr VP Myneedu, NIRTD to name a few. ]]> <![CDATA[BIRAC celebrates second birthday, Industry lauds its performance ]]> https://biospectrumindia.com/news/95/3721/birac-celebrates-second-birthday-industry-lauds-its-performance-.html https://biospectrumindia.com/news/95/3721/birac-celebrates-second-birthday-industry-lauds-its-performance-.html Mon, 24 Mar 2014 09:50:00 +0530 This year the theme for the 2nd BIRAC's foundation day was "Promoting Partnerships - Innovation Research to Product Development". The event had a participation of around 300 delegates from government, industry and academia from national and international forums. What made it unique was the foundation day lecture by Dr Sam Pitroda, chairman, National Innovation Council, on "Role of Government in fostering ecosystems for innovation". That actually set the momentum for the two day event. The event began with a welcome note by Dr Renu Swarup, managing director, BIRAC and adviser, DBT, who presented the BIRAC's journey for promoting the bio-innovation ecosystem, over the past 2 years. Prof K VijayRaghavan, chairman, BIRAC and secretary, DBT, delivered the key note talk highlighting the importance of Partnerships in achieving the vision and goal of BIRAC for creating an Innovation Research Ecosystem for Affordable Product Development. On the occasion, the theme lecture was given by Dr M K Bhan, founder chairman, BIRAC and former secretary, DBT, who emphasized on the importance of forging national and international partnerships to address the challenges faced by Indian Biotechnology sector and to make the indigenous competencies globally competitive. The second day of the event saw the presence of Mr Arun Maira, member, Palnning Commission of India. Mr Maira in his speech asked the industry to innovate and partner for the good. The event was attended by a number of International Funding Agencies - Bill & Melinda Gates Foundation, Wellcome Trust, Tekes, USAID, Grand Challenges Canada in addition to senior science counsellors and representatives from embassies. BIRAC funded 10 BIG Innovators also presented their Innovations on this occasion. BIRAC has also been responsible for the DBT-BIRAC-BMGF Grand Challenge. The five award winners for the Grand Challenges India program titled "Achieving Healthy Growth through Agriculture and Nutrition", which is managed by BIRAC under the aegis of trilateral partnership with DBT and Bill & Melinda Gates Foundation, were also announced. On this occasion two new partnerships were announced. A Joint Call on "Red Biotechnology" between BIRAC - CEFIPRA for Indo French Industry Academia Collaboration and a BIRAC - Wellcome Trust Joint Call on "Translational Medicine" with the focus on "Diagnostics for Infectious Diseases". At the closing of the event, the key recommedations were read out. These included the "To Do" list for all the verticals including agriculture, pharma, services and eductation. Overall, the industry participatants expressed satisfaction over the success of BIRAC as an organization to promote the industry. ]]> <![CDATA[Indian researchers to develop next generation toilets]]> https://biospectrumindia.com/news/95/3723/indian-researchers-to-develop-next-generation-toilets.html https://biospectrumindia.com/news/95/3723/indian-researchers-to-develop-next-generation-toilets.html Mon, 24 Mar 2014 09:33:00 +0530 Six Indian innovators have been selected to contribute to the development of sanitation solutions as part of the Reinvent the Toilet Challenge: India. From a pool of 108 applications, these projects were chosen following an extensive, rigorous selection process by an expert committee. The "Reinvent the Toilet Challenge: India" is a collaborative effort of the Department of Biotechnology (DBT), Ministry of Science and Technology, Government of India; Biotechnology Industry Research Assistance Council (BIRAC), A Government of India Enterprise; and the Bill & Melinda Gates Foundation to fund Indian researchers to develop innovative, safe and affordable sanitation technologies. This program is an India-specific program modeled on the Gates Foundation's global Reinvent the Toilet Challenge. The DBT and the Gates Foundation invested a combined US$2 million, equally split, to support Indian investigators to drive research, development, and production of "next-generation toilets." The grants were announced on March 22, 2014 by Prof. K VijayRaghavan, Secretary DBT & Chairman, BIRAC at the "Reinvent the Toilet Fair: India", an event held in New Delhi that showcased innovative products and approaches that aim to bring safe, affordable and sustainable sanitation to those who need it most. Co-hosted by the DBT and the Gates Foundation, the fair included more than 45 exhibitors representing 15 nations and featured projects to stimulate discussion among a diverse group of stakeholders working to improve global sanitation. These include efforts to create toilets that are not connected to water, sewer or electricity; improve the collection, treatment and disposal of human waste; address behavior change; and raise awareness of this critical issue for governments, stakeholders and local communities. "Effective and comprehensive sanitation seems an impossible dream for India," said Professor K VijayRaghavan. "Yet today we see a congruence of new and applicable science and technology, its affordability, and sustainable implementation. This congruence is a great opportunity which we cannot afford to let slip. By implementing effective solutions in each kind of social context, big problems can be dealt with in small units and be catalysts for scaling up. By working together to hit big barriers at the right place and the right way, they can crumble and the impossible can become real." The details of the grant recipients for the "Reinvent the Toilet Challenge: India" are as follows: 1. Eram Scientific Solutions, Kerela in collaboration with University of South Florida: A field trial grant to test off-grid, self-sustained, modular, electronic toilet for houses and communities with solar energy for Indian weather, integrated with mixed waste processing unit. The project will couple a modern, public toilet with an advanced onsite, biological treatment system. It will be housed in a standalone unit that will be initially field tested in a suburban slum. 2. Amrita School of Biotechnology, Kerela: A proof of concept grants to use viral agents to target and kill pathogens and odour-producing bacteria in fecal waste and also develop for a way to integrate this into waste treatment systems. This is a proof of concept grant. 3. Pradin Technologies, Bangalore: The project will test the concept of using ultra-sound to reduce water use in a toilet. It will also test the ability to enhance the settling of fecal particles in a storage tank using ultra-sound. This is a proof of concept grant. 4. Indian Institute of Technology Roorkee in collaboration with Fresh rooms Life Sciences: The project will develop a single household container that will cultivate Black Soldier Fly larvae, using human faeces, which can be processed into valuable products. The project will also demonstrate the market potential for these products. This is a proof of concept grant. 5. Institute of Chemical Technology, Mumbai: The project will evaluate the concept of using fine sand-like material and an air blower to create a water-free toilet interface that is free from odour and flies. 6. BITS PILANI K. K. Birla Goa Campus in collaboration with Ghent University and Sustainable Biosolutions LLP: The project will demonstrate a novel septic tank design that integrates electrochemistry to reduce organic pollutants and improve the quality of effluent discharged. The system will be demonstrated at a single household and society/gated community. This is a proof of concept grant. The Reinvent the Toilet Fair: India hosted approximately 700 attendees-exhibiting teams represented 15 nations and general participants represented 42 nations. ]]> <![CDATA[GM crops get GEAC nod, ABLE-AG calls it a progressive push]]> https://biospectrumindia.com/news/95/3722/gm-crops-get-geac-nod-able-ag-calls-it-a-progressive-push.html https://biospectrumindia.com/news/95/3722/gm-crops-get-geac-nod-able-ag-calls-it-a-progressive-push.html Mon, 24 Mar 2014 09:22:00 +0530 Finally, the much awaited meeting of GEAC took place on March 21, 2014. The 118th meeting of the commitee has happened after an year due to the non seriousness shown by the previous minister on the issue (It met in March last year). It is being said that the pressure of Mr Veerapa Moily who took over as the environment minister few months back, has made it happen despite the opposition from activists. The commitee during the lastest meeting under the chairmanship of Mr Hem Pande, secretary, environment ministry has cleared 11 cases which were pending for revalidation including the varities of the GM wheat, rice, maize and cotton. These crops had been approved for confined trails few years back but were held back because the companies could not get approval from the respective state governments. However, the multi-national ompanies like Monsanto, Mahyco and BASF whose applications got revalidation, will be able to go for field trials only after getting the state's mandatory nod. The unofficial reports suggest that the GEAC is all set to meet again on April 25, 2014 to take up the other 70 cases for the clearances. The commitee is yet to put up any official communication in this regard. Meanwhile, the Association of Biotechnology led Enterpises (ABLE-AG) has welcomed the decision. "We welcome this and hope that the rest of the applications too shall be expeditiously cleared," said Mr Ram Kaundinya, Chairman, ABLE-AG. Dr N Seetharama, Director ABLE-AG said, "Such progressive decisions pave the way for the continuation of R&D in agri biotech, so critical for the benefits of technology to percolate to farmers." "We laud the Government's reaffirmation of faith in the power of technology. At a time when agriculture is under severe stress and requires immediate infusion of technology and innovation, we can't afford to ignore biotechnology which has a proven track record of enhancing crop yields in a safe and sustainable way the world over", he added. At the saem time, the activists are not taking this kindly. The coalition for GM Free India as well as Greenpeace India had earlier requested the ministry not to take any decision on field trials of GM crops unless the Supreme Court takes its final call on the matter. The apex court is scheduled to hear the matter on April 14. ]]> <![CDATA[CoE for TB diagnostics launched to combat drug TB resistance]]> https://biospectrumindia.com/news/95/5932/coe-for-tb-diagnostics-launched-to-combat-drug-tb-resistance.html https://biospectrumindia.com/news/95/5932/coe-for-tb-diagnostics-launched-to-combat-drug-tb-resistance.html Mon, 24 Mar 2014 08:26:00 +0530 The National Institute of Tuberculosis and Respiratory Diseases (NITRD) in association with BD, a leading global medical technology company have established a Centre of Excellence for TB Diagnostics and will jointly conduct training programs and workshops to offer an opportunity to learn and practice in a world class laboratory. NITRD is the National Reference laboratory under the Ministry of Health & Family Welfare in TB and provides tertiary hospital care for patients suffering from tuberculosis (TB). It functions primarily towards patient healthcare and strategy framework in line with the Revised National Tuberculosis Control Program (RNTCP) that is the state-run TB control initiative of the Government of India. This initiative comes at a time when BD and NITRD recognize that it is critical to incorporate advanced TB diagnostic technologies for proper management of the high disease burden in the country. Through the collaboration, workshops, seminars and training programs will be conducted along with operational research to expand the utility of rapid TB culture systems as well as evaluate upcoming TB diagnostics technologies for the benefit of professionals with similar interests. Dr. V P Myneedu, Medical Superintendent and HOD Microbiology, NITRD said, "BD and NITRD have been associated with liquid culture based diagnosis of TB, MDR-TB and XDR-TB, evaluation projects on Extra-pulmonary, direct DST and many more. The association was taken one step ahead with NITRD with commitment for onsite trainings, workshops and evaluation projects and studies of new technologies. The training programs will help government as well as private institutions and professionals to learn and understand the basic and advancements in tuberculosis diagnosis, and disease management." Comprising six trainings through the year (the first training was conducted in January 2014.), lab technicians, microbiologists and chest physicians will experience hands-on training on diagnosis and management of TB. The trainings will continue all-round the year in different aspects of laboratory diagnosis of TB, relevant to TB, MDR-TB, XDR-TB management under RNTCP and Programmatic Management of Drug resistant TB (PMDT). Dr. Sanjay Sarin, Regional Director, Global Health, Asia Pacific - BD said, "India has made great progress in TB control over the last few years. Although RNTCP is investing in building the laboratory capability, management of MDR/XDR-TB remains a challenge and in that respect building laboratory capacity for TB culture and Drug susceptibility test (DST) has been identified as a critical step to enable scale-up of PMDT. BD is privileged to establish a Centre of Excellence in TB diagnostics in partnership with National Institute of Tuberculosis and Respiratory Diseases which will help establish best practices in liquid culture and DST by training microbiologists and healthcare workers." The association with BD has been long lasting, with the inclusion of liquid culture at the institute with BD BACTEC 460 instrument. Then in 2009, NITRD got BD BACTEC MGIT 960, for better improved automated diagnosis with liquid culture. The centre has conducted trainings on Culture and Isolation of Mycobacterium TB which was a five-day course and addressed hands-on training on Liquid culture isolation & differentiation. The trainees were provided complete knowledge of setting up of TB laboratory, biosafety in a laboratory, specimen collection, transport, specimen processing, and reporting. Early this month, the centre conducted a two-day Diagnosis and Management of Drug resistant TB program for chest physicians and clinicians on diagnostic tools and algorithms for Drug resistant TB diagnosis & patient management. This was provided by the national trainers in line with RNTCP programed training to physicians. ]]> <![CDATA[High End TB Test now available at subsidized price in India]]> https://biospectrumindia.com/news/95/3720/high-end-tb-test-now-available-at-subsidized-price-in-india.html https://biospectrumindia.com/news/95/3720/high-end-tb-test-now-available-at-subsidized-price-in-india.html Mon, 24 Mar 2014 08:06:00 +0530 Private labs in the country have introduced uniform reduced prices of a WHO approved Tuberculosis (TB) diagnostic test thus paving way for more patients access to one of the world's most accurate and reliable TB tests. The gold standard for TB detection - the MGIT Liquid Culture will be available at a subsidized ceiling price of Rs 900 (the maximum price laboratories can charge patients) at select labs registered with IPAQT (The Initiative for Promoting and Affordable Quality TB Tests), a coalition of over 60 private labs in India making WHO approved tests available at affordable prices to patients in the private sector. The cost varies between Rs 1100 - Rs 2000 in other private labs. Currently WHO-endorsed tests are available at specially negotiated low prices only to the public sector. Liquid culture is faster, more accurate and more comprehensive than conventional solid media or sputa smear approaches. It is particularly valuable in its ability not only to detect drug resistant TB (MDR/XDR-TB) but also in determining which drugs can be used to treat patients. It is also more effective than conventional approaches in diagnosing TB in patients co-infected with TB and HIV. In India, 73 private labs (including 15 IPAQT labs) and 50 government set ups are offering the liquid culture test. Labs in IPAQT, which operates on a high-volume, low-margin model have access to lower, negotiated prices for the quality tests in exchange of their commitment to pass on the benefits to patients. "Laboratories play a central role in patient care and surveillance. Unfortunately, the capacity of labs to deliver the quality-assured diagnostic services needed for effective treatment of control of TB, and particularly the growing threat of drug-resistant TB, is severely limited. Lab strengthening with high end test such as Liquid Culture at affordable cost is critical for effective TB treatment and control," said Dr Shalabh Malik, Head, Microbiology, Dr Lal Path Labs and a member of IPAQT. There are 4 tests approved by WHO: LED Microscope, Liquid Culture and two molecular tests viz. Gene Xpert and Line Probe Assay. Molecular-based tests provide rapid and accurate results and are preferred choice. However, molecular-based tests are expensive and costs around Rs. 3,500 per person. As per a report published in PLOS Medicine journal, the recently introduced Xpert MTB/RIF has limitations including limited shelf-life of the diagnostic cartridges, operating temperature and humidity restrictions, requirement for electricity supply, the need for annual servicing and calibration of each machine. The IPAQT initiative was started in March 2013 with the backing of 14 labs/hospitals and now has reached 61 labs (with over 3,000 collection centers) in Feb 2014. The members of IPAQT have tested 45000 TB suspects through one or more of the WHO approved TB tests as of March 2014. TB cases diagnosed are notified to the Revised National TB Control Programme (RNTCP) for linkages to free TB drugs, where necessary. "This initiative will make TB diagnosis more affordable for the private sector patients and improve the quality of TB care in the country. Any private healthcare setup with an accreditation from RNTCP, College of American Pathologists or National Accreditation Board for Laboratories can join the program and offer TB diagnosis at a subsidized rate," said Dr Jatinder Bhatia, Chief of Lab services, Metropolis Healthcare (International Chain of Diagnostics) and a member of IPAQT. To promote understanding of this technology in India, private manufacturer Becton Dickinson (BD) is working with both Revised National TB Control Program and Foundation of Innovative New Diagnostics to develop capacity for TB culture and drug susceptibility testing in 33 laboratories across India. Under the initiative, best practices are being taught using BD BACTEC MGIT liquid culture systems, quality control and quality assurance of laboratory practices. As per Dr Ranjan K Nanda, scientist, International Centre for Genetic Engineering and Biotechnology, "The culture based test will remain as a gold standard and capacity building for the test should be given high priority in every state of our country. TB and/or HIV incidence rates could be used as an important indicator for identifying locations to facilitate culture test." Dr Vithal Prasad Myneedu, Sr Microbiologist & HOD, Dept Of Microbiology, LRS Institute of TB & Respiratory Diseases said, "International TB laboratory experts also recommend the use of TB liquid culture systems in low-income settings. They are the standard of care for TB diagnosis in developed countries and will revolutionize the scenario in India once adopted widely." India ranks #1 in the world and constitutes 1/5th of the global TB burden. Every year, in India close to 2 million people develop the disease with nearly 40% of them being infectious. As per WHO, India along with China contributes nearly 50% to the global burden of Multiple Drug Resistant TB (MDR-TB). It is estimated that more than 70% of Indians seek first contact medical care in the private sector and more than 50% of all TB patients in India are treated in the private sector. The WHO has discouraged blood tests for TB and in June 2012, the Government of India banned their use as they were highly inaccurate and provided misleading results. ]]> <![CDATA[Ranbaxy awards deserving researchers ]]> https://biospectrumindia.com/news/95/5956/ranbaxy-awards-deserving-researchers-.html https://biospectrumindia.com/news/95/5956/ranbaxy-awards-deserving-researchers-.html Mon, 24 Mar 2014 07:51:47 +0530 Ranbaxy Science Foundation (RSF), a non-profit organisation set-up by Ranbaxy Laboratories Limited, on March 24, 2014 announced its Ranbaxy Research Awards 2012 for excellence in original research work in Medical and Pharmaceutical Sciences. The Foundation also announced the Annual Science Scholar Awards to the young and brilliant new generation of scientists. The Awards were presented by internationally acclaimed scientist, Pierre Alain Clavien, Professor & Chairman, Department. of Surgery, University Hospital in ZÃ¼rich, Switzerland, at a function held today at National Institute of Immunology, New Delhi. Dr. Tsutomu Une, Ranbaxy's Chairman and Padma Shri Dr. Nitya Anand, Chairman of Ranbaxy Science Foundation were also present at the award ceremony. The awards were given to five scientists and five science scholars. Outstanding research scientists honoured for excellence in original research work in Medical and Pharmaceutical Sciences were: Medical Sciences - Basic Research: Prof. Umesh Varshney, Professor, Department of Microbiology and Cell Biology, India Institute of Science, Bangalore, for his pioneering discoveries in the areas of protein synthesis and DNA repair using Escherichia coli and mycobacteria as model organisms. Medical Sciences - Medical Research: The Award was jointly shared by Prof. Kanjaksha Ghosh, Director, National Institute of Immunohaematology, Mumbai and Prof. Saumitra Das, Professor, Department of Microbiology & Cell Biology, Indian Institute of Science, Bangalore. Prof. Ghosh received the award for his significant contribution in understanding and economic management of congenital bleeding disorders. Prof. Das received the award for his outstanding contribution towards developing novel antiviral agents against Hepatitis C virus. Medical Sciences - Clinical Research: Prof. Parmjeet Randhawa, Professor of Pathology, Division of Transplant Pathology, University of Pittsburgh, USA was bestowed with the Award for recognising BK virus nephropathy masquerading as rejection in the era of modern immunosuppression. BK virus PCR initially developed for research is now a routine diagnostic and screening tool. Pharmaceutical Sciences: Prof. Sandeep Verma, Shri Deva Raj Chair Professor, Department of Chemistry, Indian Institute of Technology, UP was given the award for outstanding contribution in creating novel, self-assembling peptide scaffolds to mimic aggregation of amyloidogenic proteins and for using them as screens to discover inhibitors of these processes. The Science Scholar Awards in the field of Bio-Medical Sciences were given to Kumar Somyajit, Senior Research Fellow, Department of Biochemistry, Indian Institute of Science, Bangalore; Priyanka P. Trivedi, Ph.D. Scholar, Facility for Risk Assessment & Intervention Studies, Department of Pharmacology and Toxicology, NIPER, Punjab; Pushpa Mishra, Senior Research Fellow, Department of Chemistry, Tata Institute of Fundamental Research, Mumbai. In the field of Pharmaceutical Sciences, the Awards were given to Priyanka Shreekrishna Gokhale, PhD Student, Department of Infectious Diseases Biology, National Institute for Research in Reproductive Health, Mumbai and Chetan Prakash Yewale, Senior Research Fellow, Pharmacy Department, Faculty of Technology and Engineering, Maharaja Sayajirao University of Baroda. Earlier during the day, Ranbaxy Science Foundation organised its 20th Annual Symposium on "Regenerative Medicine - Current and Future Perspectives" in association with the Institute of Liver and Biliary Sciences, New Delhi. The Chief Guest, Dr. R. Chidambaram, Principal Scientific Adviser to the Government of India delivered the inaugural address followed by the key note address by Prof. Pierre Alain Clavien. Eminent scientists from India and abroad participated in the symposium and deliberated on the recent advances in regenerative medicine and stem cell therapy and its recent applications in various disease areas such as kidney disorders, type II diabetes mellitus, neuronal disorder, ocular disorders, liver injury, cardiac disorders etc. Ranbaxy Science Foundation received an overwhelming response when the nominations for Ranbaxy Research Awards opened in May 2013. The nominations were then evaluated by a Panel of Jury comprising 11 distinguished scientists from all over India. Ranbaxy Science Foundation (RSF), presently chaired by Dr. Nitya Anand, is a non-profit organization, promoted by India's leading pharmaceutical company, Ranbaxy Laboratories Limited. RSF aims to encourage scientific endeavour in the country by rewarding excellence in medical and pharmaceutical research and channeling national and international knowledge and expertise. Among the prime activities it undertakes every year are presenting Ranbaxy Research Awards to the Indian scientists for outstanding research work and Ranbaxy Science Scholarship Awards to the young and brilliant science scholars, presenting special award for outstanding work in the field of public health, holding of Scientific Symposia in frontline areas of research, inviting Foreign Scientists as Visiting Professors, holding Round Table Conferences on topics of public health concern and publishing the proceedings of symposia and Round Table Conferences. Ranbaxy Laboratories Limited, India's leading pharmaceutical company, is an integrated, research based, international pharmaceutical company producing a wide range of quality, affordable generic medicines, trusted by healthcare professionals and patients across geographies. Ranbaxy serves its customers in over 150 countries and has an expanding international portfolio of affiliates, joint ventures and alliances, ground operations in 43 countries and manufacturing operations in 8 countries. Ranbaxy is a member of the Daiichi Sankyo Group, a leading global pharma innovator headquartered in Tokyo, Japan. ]]> <![CDATA[Global Hospitals Group opens its door for Mumbai]]> https://biospectrumindia.com/news/95/6653/global-hospitals-group-opens-its-door-for-mumbai.html https://biospectrumindia.com/news/95/6653/global-hospitals-group-opens-its-door-for-mumbai.html Fri, 21 Mar 2014 17:58:57 +0530 Mumbai now has a multi-super-specialty tertiary care hospital that is one of India's leading hospital chains in complex surgeries and multi-organ transplantation. The Global Hospitals Group with experience and expertise of performing successfully over 600 Liver transplants at its world class hospitals at Hyderabad, Bangalore and Chennai, has opened its doors for liver transplant patients at its state-of-the-art Mumbai Hospital facility at Parel. Their first successful Liver Transplant surgery at Mumbai has been performed by world renowned Liver transplant Surgeon & Director of the Group's HPB Surgery & Liver Transplant Program, Prof. Mohamed Rela at the Global Institute of Liver Diseases, HPB Surgery and Transplantation. Mr Nikunj Kapadia, a 67 year old Mumbai based businessman was the first patient to get a new lease of life through Liver Transplant at Global Hospitals Mumbai. Mr Kapadia was suffering from Liver Cirrhosis and only option available to him was through a Liver Transplant surgery. Mr Nikunj patiently had to wait for a Cadaver Donor before his son Mr Munjal Kapadia, aged 36 years decided to donate a portion of his liver to him. Dr K Ravindranath , CMD of Global Hospitals Group said, "At Global Hospitals Group, all of us share a common vision, which is to be a world-class medical services provider turning distant possibilities into today's realities. We constantly innovate and pioneer path-breaking healthcare services that are revolutionary and advanced; to cater to the healthcare needs of the diverse and ever evolving populace". It is estimated that about 2 lakh people are diagnosed with end stage liver disease per year and about 0.02% population (25000) need liver transplants per year. The need of the hour is to increase awareness about organ donation. "Our aim is to provide excellence in patient care. Excellence is not just defined by the number of surgeries or transplants we have performed, it is about providing highest possible quality of care and service on a consistent basis and making a difference to the lives of the patients who visit us. We aim to provide the same kind of care to the people of Mumbai", said Prof. Mohamed Rela, director, HPB & Liver Transplant Program, Global Hospitals Group. Global Hospitals was one of the very first to start liver transplant programs in India and is the only Group which has sustained the program since 2003 and has over a decade of experience, including more than 600 liver transplants for both adult and pediatric. ]]> <![CDATA[Let's make India known for innovations]]> https://biospectrumindia.com/views/95/5681/lets-make-india-known-for-innovations.html https://biospectrumindia.com/views/95/5681/lets-make-india-known-for-innovations.html Fri, 21 Mar 2014 17:33:00 +0530 As a scientist-turned entrepreneur, my journey has taken a long time, with many struggles along the way. For an entrepreneur every step is a milestone. He must possess a keen eye to identify problems of the society and solve them. I was born into a middle class agricultural family in a village near Thiruthani, Tamil Nadu. I studied agriculture, against my father's wish and began my career with Bayer's agricultural division due to economic pressure. The Rotary Foundation's Freedom from Hunger Scholarship bolstered my ambitions and allowed me to pursue my MS from the University of Hawaii, US, and subsequently get a PhD, in molecular biology from Department of Plant Pathology, University of Wisconsin- Madison. It is at the University of Wisconsin-Madison that I learnt to think, analyse and carefully interpret science. My thought processes and appreciation for science were transformed while listening to lectures by Nobel laureates and National Science Academy winners at the University.I always believed in taking the unconventional approach and to further research after my PhD, and teaching, I joined the Medical University of South Carolina-Charleston. It was here that I first began to think that I need to pursue the path of entrepreneurship if I were to do something for the society. It was a tough decision, especially to leave a flourishing professional career. But, two women in my life, my mother and my wife Suchitra, backed my decision to return to India in 1996 to start my entrepreneurial journey. After the touching down in India, my first challenge came from policy makers and regulatory authorities who were neither familiar with the word 'biotech' nor convinced on its outcomes. Given my background as a first generation entrepreneur from a farming background, raising funds for my project was a huge struggle at the beginning stage of my entrepreneurial journey was to. At that very time, another biotech company had submitted a Rs 65-crore (Rs 650 million) proposal and mine was for Rs12.5 crore (Rs 125 million). My proposal did not find favor as it was all together a new environment for them and, as a subject with no benchmark in the country, they also felt that I didn't know what I was doing. I did not let this setback deter me from my goal- I knew exactly what I was doing and overcame this problem with funds and committed support from my family and fellow scientists from the US, who were convinced with my vision for Bharat Biotech. Money never motivated me to become an entrepreneur. It was the hunger to develop a novel approach to make an indigenous vaccine for India, one that was not only world class but also affordable. I wanted to use what I learnt during my interactions with professors and Nobel Laureates to realize this vision, and with a team that shared the same passion and substantial understanding to make science work. To achieve this, my team of young scientists and I, took a bold step to build an indigenous world class R&D and manufacturing facility with innovation at its heart. We set out and developed an indigenous Himax technology that allowed us to bring down the cost of the production for hepatitis B Vaccine. This also made us the first company in the world to introduce cesium chloride-free hepatitis B vaccine. Innovation is at the heart of our business mission. It motivates us. Our focus was to foster initiatives that can tackle the regional diseases that affect developing world populations. This not only gave us leadership status in the sector but also the confidence that we have the capabilities to develop novel vaccines like global MNCs. In January 1999, we rolled out our first product Revac-B, our hepatitis B vaccine. With over 500 million doses delivered for the Government of India's National Immunization Program at Rs 10/- a dose, we achieved the milestone of being the largest producer of hepatitis B vaccine doses with exports to Pakistan, UNICEF and Latin American markets, amongst others. We love challenges. Our next goal, as committed to the Bill and Melinda Gates Foundation, was to develop and supply Rotavac at $1-a-dose. One of the most satisfying moments in my journey as an entrepreneur came in 2013, when we declared successful results of our social innovation program Rotavac phase III safety and efficacy clinical trial program in 8,000 subjects in the entire developing world conducted in the new born babies with investment of `350 crore under International Public Private Partnership supported by National Scientific Agencies and theGates Foundation. Last year we launched two path-breaking vaccines, Typbar TCV, the world's only typhoid conjugate vaccine that can be given to both children below the age of six and adults; followed by Jenvac. Very soon we will roll out Rotavac in the market. The three vaccines will always be fine examples of what successful public-private partnerships. I feel proud that Bharat Biotech catalyzed the creation of the Genome Valley in Hyderabad, which is a hub for more than 100 knowledge-based biotech companies. This was possible as we were advisor to the former government. We convinced them to create a genome valley that led to the development largest biotech cluster in India. In these 15 years of journey we are also proud to have delivered 2.8 billion doses and were also responsible for polio eradication. Today, our company delivers vaccines to over 65 countries around the world.Running a successful and profitable company is an incredibly trying experience that takes dedication, hard work, and sacrifice. Wearing hats like that of a scientific advisory member to the Union Cabinet of the Government of India and chairman and board of governors, NIT, Warangal, today enables me to contribute back to the society to create a better eco system for innovation and entrepreneurship and also putting emphasis to build a stronger PPP environment. For an enterprise to succeed, it must also collaborate with government and regulatory agencies and the financial institutions in a balanced manner. I must say that the Technology Development Board, DBT, and Department of Science and Technology, BIRAC and CSIR gave their immense moral support and financial assistance in our journey of growth. Especially, financial institution like the SBI, who believed in our enterprise vision and offered their continuous support when I was in dire need. An enterprise must work in harmony with financial institution and scientific establishment and regulatory agencies to make India an innovative country. Dr Krishna M Ella is founder chairman of Bharat Biotech International, Hyderabad. He was the BioSpectrum Entrepreneur of the Year 2003 and BioSpectrum Person of the Year 2013 ]]> <![CDATA[CitiusTech collaborates with General Atlantic]]> https://biospectrumindia.com/news/95/3719/citiustech-collaborates-with-general-atlantic.html https://biospectrumindia.com/news/95/3719/citiustech-collaborates-with-general-atlantic.html Fri, 21 Mar 2014 15:56:59 +0530 CitiusTech, a leading provider of healthcare technology services and solutions, announced a significant investment from global growth equity firm, General Atlantic LLC (GA). Financial details were not disclosed. CitiusTech partnered with over 50 leading healthcare organizations worldwide providing deep healthcare domain expertise and unique technology offerings to its clients. With over 1,400 professionals, CitiusTech has amongst the largest product engineering and professional services teams for building and implementing enterprise clinical applications worldwide. BI-Clinical, CitiusTech's flagship healthcare BI and analytics platform, is deployed at over 3,800 provider locations, making it one of the most widely used ONC certified reporting and analytics platforms in the US market. "Smart, strong technology helps more people achieve better health outcomes," said Mr Bill Ford, CEO of General Atlantic. "CitiusTech's platforms help healthcare organizations and health care technology providers accelerate innovation and drive improvements in the cost and quality of care. We are proud to partner with CitiusTech and to support its growth." Mr Rizwan Koita, chief executive officer of CitiusTech said, "The partnership with GA enables CitiusTech to leverage General Atlantic's global presence and its expertise in the technology and healthcare marketplaces. We are excited to partner with General Atlantic and look forward to working closely to scale our business worldwide." CitiusTech reported a 51% growth in corporate revenues in 2013, making it the sixth consecutive year of more than 50% revenue growth. ]]> <![CDATA[Piramal Imaging's Neuraceq receives FDA approval]]> https://biospectrumindia.com/news/95/5272/piramal-imagings-neuraceq-receives-fda-approval.html https://biospectrumindia.com/news/95/5272/piramal-imagings-neuraceq-receives-fda-approval.html Fri, 21 Mar 2014 12:18:00 +0530 Piramal Imaging announced that the US Food and Drug Administration (FDA) has approved Neuraceq. Neuraceq is indicated for Positron Emission Tomography (PET) imaging of the brain to estimate beta-amyloid neuritic plaque density in adult patients with cognitive impairment who are being evaluated for Alzheimer's disease (AD) and other causes of cognitive decline. There are an estimated 7.7 million new cases of dementia each year worldwide. Alzheimer's disease accounts for 60-80% of all dementia diagnoses. However, a clinical diagnosis of probable AD is incorrect upon post-mortem histological investigation in 10-30% of cases.3 The Centers for Medicare & Medicaid Services (CMS) has declared it will cover a beta-amyloid PET scan for patients under Coverage with Evidence Development (CED) programs. The objective of these programs is to assess the impact of beta-amyloid scans on improving patient outcomes or advancing patient treatment options. "Alzheimer's disease or any form of cognitive impairment is a daunting diagnosis," said Dr Ludger Dinkelborg, director of the board, Piramal Imaging. "For the patients and caregivers, the concern centers around understanding what the future holds. For physicians, the challenge is properly assessing the patient and determining the best care path." "The FDA's approval of Neuraceq is a significant milestone for Piramal Imaging and demonstrates our dedication to advancing innovation in molecular imaging globally," said Dr. Swati Piramal, vice chairperson, Piramal Enterprises, Ltd. "The rising prevalence of Alzheimer's disease and cognitive impairment is being felt individually and collectively around the world. Our goal as a company is to usher in a new era of imaging that helps paint clearer pictures of the physiology of such conditions and help improve patient outcomes." The FDA approval of Neuraceq is based on safety data from 872 patients who participated in global clinical trials as well as three studies that examined images from adults with a range of cognitive function, including 205 end-of-life patients who had agreed to participate in a post-mortem brain donation program. Images were analyzed from 82 subjects with post-mortem confirmation of the presence or absence of beta-amyloid neuritic plaques. Correlation of the visual PET interpretation with histopathology in these 82 brains demonstrated that Neuraceq accurately detects moderate to frequent beta-amyloid neuritic plaques in the brain and is a useful tool to estimate the density of these plaques in life. Piramal Imaging has partnered with IBA Molecular for manufacturing and distribution of Neuraceq . IBA Molecular owns and operates a network of 49 PET isotope facilities worldwide, a network that is unique in both size and scope. ]]> <![CDATA[Asia Pacific's NSCLC market to show robust growth by 2019]]> https://biospectrumindia.com/news/95/3717/asia-pacifics-nsclc-market-to-show-robust-growth-by-2019.html https://biospectrumindia.com/news/95/3717/asia-pacifics-nsclc-market-to-show-robust-growth-by-2019.html Thu, 20 Mar 2014 15:37:00 +0530 The GBI Research has revealed that the non-small cell lung cancer (NSCLC) therapeutics market value in the Asia-Pacific (APAC) region - Australia, China, India and Japan - is likely to increase at CAGR of 6.3 percent during 2012-2019 to $2.9 billion by 2019 from $1.8 billion in 2012. Japan and China had the largest shares of the region's NSCLC market in 2012, with 48.5 percent and 41.5 percent, respectively. Meanwhile, Australia and India had lower shares of 5.9 percent and 4.1 percent. "Additionally, the expected launches of premium-priced novel antibodies and immunotherapies in the first and second lines of therapies, targeting both Squamous and Non-Squamous NSCLC patients, will widen the eligible treatment population. This will ultimately maximize the patient share and provide a boost for the market," commented Ms Sravanthi Addapally, senior analyst, GBI Research. Currently, the NSCLC pipeline is very strong, with a total of 290 active molecules in development, either as monotherapies or in combination with chemotherapy. Promising candidates in the late-stage clinical trials include second-generation Tyrosine-Kinase Inhibitors, such as Pfizer's dacomitinib and Boehringer Ingelheim's Gilotrif. This latter therapy is currently a pre-registration drug in Japan for Epidermal Growth Factor Receptor-positive patients. "In spite of many expected drug launches, growth in this treatment market is forecast to be marginal due to the dominant generic penetration of NSCLC drugs in India. A complex and lengthy regulatory pathway and limited reimbursement from national insurance programs in China, as well as regular price cuts in Japan, will also hinder further market expansion in the APAC region." added Ms Addapally. GBI Research report , NSCLC Therapeutics in Asia-Pacific Markets to 2019 - Personalized Therapies Focus on Untapped Segment of Squamous Cell Carcinoma to Expand Treatment Pool, analyzes the non-small cell lung cancer (NSCLC) treatment usage patterns, market characterization, pipeline analysis and key licensing and co-development deals in Australia, China, India and Japan. This report was built using data and information sourced from proprietary databases, primary and secondary research, and in-house analysis conducted by GBI Research's team of industry experts. ]]> <![CDATA[Bill & Melinda Gates Foundation donate $15 million to improve sanitation across Asia]]> https://biospectrumindia.com/news/95/3716/bill-melinda-gates-foundation-donate-15-million-to-improve-sanitation-across-asia.html https://biospectrumindia.com/news/95/3716/bill-melinda-gates-foundation-donate-15-million-to-improve-sanitation-across-asia.html Thu, 20 Mar 2014 14:24:41 +0530 Last year, the Asian Development Bank created the Sanitation Financing Partnership Trust Fund to help provide safe sanitation to families in Asia's cities and rural communities who still lack access to basic sanitation facilities and services. ADB is leveraging the Bill & Melinda Gates Foundation's $15 million contribution to finance more than $28 million in non-sewered sanitation and septage management projects across the region in the next 5 years. "The ADB and the Bill & Melinda Gates Foundation share the similar vision of bringing innovative solutions to Asia's sanitation sector, said Amy Leung, director of the Urban Development and Water Division in ADB's Southeast Asia department. "We are proud to support new testing and pilot implementation of innovative solutions to hasten access to safe sanitation for Asia's urban poor." "Open defecation and inadequate toilets, sewers, and wastewater treatment systems lead to massive amounts of untreated human waste in the environment, harming the health and well-being of children,," said Brian Arbogast, director of the Water, Sanitation & Hygiene team at the Bill & Melinda Gates Foundation. "We are delighted to have new partners like the ADB applying creative thinking to more effectively managing human waste to improve people's lives." Recognizing that increasingly complex urban and coastal environments require new approaches to septage management, three projects have received funding support from the Sanitation Financing Partnership Trust Fund: South Asia Urban Knowledge HubThe South Asia Urban Knowledge Hub (k-hub) is a network of four research and training institutions in Bangladesh, India, Nepal, and Sri Lanka supported by ADB to facilitate information and experience exchange within South Asia among city managers, utility staff, policy makers, academics and the private sector for improved service delivery. The k-hub activities will include support to national centers in developing business plans that structures the national centers' work and capacity needs for promoting innovative urban sanitation. Pilot and Demonstration Activity Facility The trust fund has set aside $2 million for ADB's Facility for Pilot and Demonstration Activity. The new funding will support the testing and validation of pilot approaches to policies, technologies and business models to improve sanitation management and water services delivery with the intent to replicate and scale-up successful approaches across the region. Septage Management in Coastal Towns in Bangladesh An additional $1.6 million grant from the Trust Fund will support pilot innovations in sanitation and septage management as part of a planned ADB loan to Bangladesh for coastal town infrastructure improvements. The new grant will support pilot projects in eight towns to improve septage collection and treatment systems. The grant will also support capacity building for improved septage operation and maintenance in addition to promoting private sector participation in septage management. ]]> <![CDATA[EFSA reaffirms safety of aspartame for consumers]]> https://biospectrumindia.com/news/95/3715/efsa-reaffirms-safety-of-aspartame-for-consumers.html https://biospectrumindia.com/news/95/3715/efsa-reaffirms-safety-of-aspartame-for-consumers.html Thu, 20 Mar 2014 13:11:00 +0530 The authority based its findings on one of the most comprehensive risk assessments of aspartame and its breakdown products ever undertaken. It involved a rigorous review of all available scientific research, including both animal and human studies. After a detailed analysis and considering all available information, the EFSA experts concluded that the current Acceptable Daily Intake (ADI) of 40mg per kg of body weight daily does not pose any long or short-term health concernfor people. (The ADI level is an estimate of the amount a person can consume each day over a lifetime without risking their health.) The EFSA experts have firmly ruled out the possibility of aspartame causing damage to genes and inducing cancer. They have also concluded that the substance does not harm the brain, the nervous system or affect behaviour or cognitive function in adults. Dr Dheeraj Kapoor, consultant, endocrinology and diabetes, Kokilaben Dhirubhai Ambani Hospital says, "Safety concerns have been aired on and off about the consumption of aspartame ever since the product was approved around 25 years ago as a food additive. It has proved to be a boon to people who needed to avoid table sugar. I hope that this comprehensive review of aspartame by EFSA experts finally puts all controversy about its safety to rest. This should also strengthen the consumer confidence in the aspartame based products." Aspartame is an artificial but intense low-calorie, non-saccharide sweetener that is being used in yogurts, chewing gum, diet foods, soft drinks and other low-calorie or sugar-free foods throughout the world. It is a white, odourless powder, approximately 200 times sweeter than sugar. ]]> <![CDATA['Entrepreneurs should speak the language of their ecosystem']]> https://biospectrumindia.com/features/95/7677/entrepreneurs-should-speak-the-language-of-their-ecosystem.html https://biospectrumindia.com/features/95/7677/entrepreneurs-should-speak-the-language-of-their-ecosystem.html Thu, 20 Mar 2014 11:15:00 +0530 An academician by profession and having a doctorate degree in Chemistry from the prestigious Yale University, today he dons a dual-role as an entrepreneur and as well as a professor of Chemistry at the University of Hyderabad. Academics Vs Entrepreneurship Says Dr Nangia, "It started about four years ago. There are many discoveries which happen in the academic realm having great commercializing potential and practical applications for real world situations. So far in the academic realm, professors were depending on someone to commercialize their discoveries." In 2009, the government felt the need to empower professors and academicians to commercialize their inventions. It brought out a scheme called 'Knowledge Equity' in 2009, which is based on the common model seen in the US and UK, where professors run their own companies parallely without giving up their teaching careers. "We took advantage of this new scheme which allowed academicians to run their companies along-side being professors. It is a breakthrough innovation and the thinking of the policy-makers was futuristic in terms of starting Technology Business Incubator (TBI) labs. Thus, Crystalin Research started in January 2010," adds Dr Nangia. "Now both, my company and academic research labs are located in the same campus of Hyderabad University." He further emphasized, "It is very convenient to monitor both the work simultaneously. We have also applied for DSIR certification for our R&D labs to the Department of Science & Technology (DST), and we were granted the certification." From chalk-to-salt The company's main focus is in the area of pharmaceuticals. Dr Nangia back then felt that rather than making molecules in drug discovery, they would work on doing late-stage drug translation. This process favorably caters to the existing current situation of expecting faster turnarounds and limited budgets in the industry. "Rather than starting the race at the beginning of the line, we wanted to take up the race at the last mile modification stage. We took leading drug molecules in the market, or molecules which had cleared the clinical trials stages, and focused on developing exact forms in which the drug will be made in to a crystalline or tablet form," elucidated Dr Nangia. The company was officially registered in 2011 and was given the name 'Crystalin Research', which is an amalgamation of 'crystal' and 'India', as the company's work primarily deals with solid-state crystals. Speaking about the company's services, Dr Nangia opines, "There was a realization that drug forms can improve or modify the therapeutic efficacy. Our main focus is chalk-to-salt. That is, we take insoluble drug molecules and make it in to soluble drug forms." He continues, "We also work on molecules which are in late-stage of their therapeutic efficacy, stability, formulation, drug characteristic, and drug effectiveness." Essentially, low solubility of chemicals is considered a rate limiting step for many pharmaceutical companies in the process of drug manufacturing. "With the chalk-to-salt platform technology, we have a task of taking drug molecules and improve its efficacy by improving the viability. Viability is a big rate limiting factor for drug efficacy. More than 80% of pharmaceuticals are sold in the tablet form," explained Dr Nangia. Crystalin Research mainly caters to genomics and pharmaceutical industry who are seeking leads in terms of drug formulations, drug modifications, repurposing of drugs, and renewing old drug formulations as new entities with new and improved properties. "More specifically we work with small and mid-sized companies who do have the necessary infrastructure as they find us attractive," he adds. The challenges The biggest challenge was to begin a start-up hailing from an academic background, said the academician-turned-entrepreneur. "It took more than a year to convince people that one can play dual roles. It is difficult to get across to people that one can navigate across these two zones seamlessly. Secondly, we are only a R&D company. So people often ask us how we earn and sustain. Companies that are 200% dedicated to R&D is a new concept in India, but now their numbers are increasing in the start-up cluster. Thirdly, even though we are an R&D company, we need a revenue chain to sustain ourselves," expresses Dr Nangia. For sustenance, to some extent the company has committed towards carrying out CRO activities for projects belonging to large and mid-sized companies. "The companies will own the IPs (Intellectual Property) that we develop and we charge them accordingly. And that is how we sustain," he adds. VCs and woes When asked about funding through venture capitalists, Dr Nangia says, "I made two observations about venture capitalists. Their time frames are very short, which is about 3 months. Most R&D start-ups need 1 to 2 years to establish themselves well. We were way far beyond their waiting time. So I knew none of our products can be brought to the market within 3 months. Hence we didn't aggressively pursue VCs for our funding." "When you receive large amounts from VCs, you need to be committed to deliver the results in a relatively shorter time period. I think the key missing link here is that when you need funding below 1 crore, you can approach the DBT for your aid. When you need funding above 5 crore, VCs gladly support you," commented Dr Nangia. "However when you need funds between 2 and 5 crore, then VCs backtrack because they feel that the project is not of critical size or mass. There is a need to bridge this so called 'valley of death', which is between Rs 2-5 crore of capital fund-raising." No setbacks! When asked about initial setbacks faced, Dr Nangia responded saying, "So far we didn't have serious setbacks. We were fortunate enough. I take small steps, and I take those steps when I have enough reserves to go to the next step, and then move forward. We have taken the slow route, rather than multiplying very fast. We multiply in a modest way and we are playing it very conservative." According to Dr Nangia, human resource is pivotal in R&D. "You are completely relying on your employees for successful outcomes. If they can find innovative solutions on the lab bench, it enables you to discover and innovate faster," he adds. "Most of our people have master's, doctoral or technical degrees in chemistry, biology, biotechnology, and biochemistry. We'll expand depending on the flow of projects based on the need and requirement." For young entrepreneurs "For any biotech or pharma start-up," says Dr Nangia enthusiastically, "I would suggest them to be associated with a university or an institute cluster. This will enable them to take advantage of facilities and infrastructure to avoid burning heavy capital right at the start." "The best way to start is to start where you have ten other companies like yours. This will give a sense of moral confidence and share facilities, since you can't build everything on your own." Building an enterprise is like boot-strapping. Entrepreneurs should build on their core strength first and then expand to the peripheral areas. "Once the core is strong, the periphery automatically will be strengthened. Start with a core strength and then build the second and the third, and then the periphery. Companies should engage in a dialogue with the government which will be effective and supportive. Start-ups usually get frustrated with government agencies and complain about Indian bureaucracy," he says. "Many start-ups are started by people who have worked in the US or other developed countries, and they tend to speak the language of that ecosystem. This will not work in India," he affirmatively explained. Deeper and wider Talking about the company's futuristic ventures, he says, "We have done some level of translational drug from lab to preclinical stage. Essentially, it is all about lab-to-market or bench-to-bedside. We would like to see one of our products moving in to human clinical trial phase." "One of our objective is to penetrate deeper and wider. There are good opportunities in the generics industry in India," Says Dr Nangia. Innovation and visibility Dr Nangia explained that innovation is different from visibility. "We are a hierarchy-less organization. We go by what a person contributes rather than the kind of education or experience he or she has. There are freshers who are sharper and aggressive than an experienced senior personnel. So we ensure that people interact with each other. Lastly, we work like an academic lab. We allow full flexibility to our employees as long as the work gets done thoroughly," he says. Government's role The government is a key catalyst in supporting start-ups, feels Dr Nangia. "It (government) has reasonably done well in the last 5 years. Several new schemes from DBT, DST, and CSIR are talking and thinking on the same wavelength. DBT's BIRAC and BIG scheme is on the similar lines compared to the US. At times, private funding is a major challenge. BIRAC and DBT can develop risk-evaluation based equity to fund start-ups in the biotech," he advises. Public-private partnership Most start-ups by their very nature are public-private partnerships, thinks Dr Nangia. "They can't be 100% relying on themselves," he states. "They either need to go to an institute or a university or an innovation cluster lab. Only when a start-up grows up completely, it can stand on its own without a PPP platform. Hence, PPP, start-ups and innovation labs are part of the same growth system." The future "In the Indian environment, I would like to see the academia-industry partnership ecosystem become well integrated with technology, innovation labs and centers. More scientists should be empowered to start their own companies. In that way, many of the discoveries will move from lab to scale-up, and translation studies to the market, in a natural way," ends Dr Nangia optimistically. ]]> <![CDATA[Sanofi and UCB partner to innovate in immune-mediated diseases ]]> https://biospectrumindia.com/news/95/3714/sanofi-and-ucb-partner-to-innovate-in-immune-mediated-diseases-.html https://biospectrumindia.com/news/95/3714/sanofi-and-ucb-partner-to-innovate-in-immune-mediated-diseases-.html Wed, 19 Mar 2014 16:50:46 +0530 These molecules will have the potential to treat a wide range of immune-mediated diseases in areas such as gastroenterology and arthritis. "Immune-mediated diseases affect individuals, families, and communities and impact the economies of countries and nations, making this poorly understood category of diseases a significant public health burden," said Dr Elias Zerhouni, president, global R&D, Sanofi. "Joining efforts with UCB, we will address a scientific challenge in immunology, and increase the chances of accelerating the discovery and development of future therapies," he added. "We partner Sanofi's significant expertise, strong capabilities and resources with UCB's cutting-edge research skills and breakthrough innovations. Together we can maximize the opportunity to treat diseases currently treated by biologic agents with small molecules and thus benefit millions of people suffering from severe diseases," commented Mr Ismail Kola, president, UCB NewMedicines. UCB NewMedicines, the research arm of UCB, has used an innovative approach to identify small molecules modulators of a biological pathway, for which parenterally administered biologic therapies have proven highly efficacious in patients. A dedicated team of scientists will be formed under the leadership of Sanofi and UCB, and will join forces in a discovery and development based collaboration to characterize and identify new potential therapies. Under the terms of the agreement, Sanofi and UCB will share costs and profits on a 50/50 basis. UCB will be entitled to initial upfront, preclinic al and clinical development milestone payments from Sanofi, potentially exceeding â‚¬ 100 million. ]]> <![CDATA[Horizon Hospital launches life saving â€œECMOâ€? treatment]]> https://biospectrumindia.com/news/95/3713/horizon-hospital-launches-life-saving-ecmo-treatment.html https://biospectrumindia.com/news/95/3713/horizon-hospital-launches-life-saving-ecmo-treatment.html Wed, 19 Mar 2014 16:45:02 +0530 When heart or the lung fails initially, the oxygen is provided by ventilator. However this has limitations. After a certain point, the ventilator cannot provide further and the rest of organs start failing. At this point "ECMO" works as a complete heart & lung support. The Hospital under the dynamic leadership of Dr Hrushikesh U Vaidya has a well equipped Critical Care Unit, to provide acute care for those patients who are generally unstable, critically ill and those requiring advance monitoring and intensive treatment. The critical care team comprises of highly skilled Intensivist, qualified and trained team of resident doctors and nursing staff. The ICU core team is supported by all super-specialist - Cardiologist, Physician, Diabetologist, Surgeon, Orthopedic an, Neurosurgeon, Neurologist & other medical and surgical specialist round the clock. Speaking on the occasion, Dr Hrushikesh U Vaidya opined, "Today the medical technology has moved ahead with latest innovations in critical care, with the launch of 'ECMO' we are moving towards our objective in making Horizon hospital one the best hospital for critical care in India." ]]> <![CDATA[Bayer invest 500 million Euros to expand its capacity]]> https://biospectrumindia.com/news/95/5519/bayer-invest-500-million-euros-to-expand-its-capacity.html https://biospectrumindia.com/news/95/5519/bayer-invest-500-million-euros-to-expand-its-capacity.html Wed, 19 Mar 2014 16:11:00 +0530 The investigational therapy options for hemophilia patients - a plasma protein-free rFVIII (BAY 81-8973) and a long-acting rFVIII (BAY 94-9027) - are both currently in Phase III clinical trials. In February 2014, Bayer HealthCare announced positive results from the PROTECT VIII trial evaluating Bayer's site-specific PEGylated rFVIII (BAY 94-9027). "This investment will be one of the largest in the history of Bayer HealthCare and reflects our strong commitment in the field of hemophilia A," said Dr Olivier Brandicourt, ceo, Bayer HealthCare. Bayer's approved hemophilia A therapy product Kogenate FS/Kogenate Bayer is manufactured exclusively in Berkeley, California, USA. Establishing an additional supply source in Germany will help the company to prepare for production of the anticipated new therapy options and address the growing demand in this therapeutic area. Subject to the results of the ongoing clinical trials, Bayer is planning to file BAY 81-8973 for approval with the regulatory authorities in the second half of 2014 with first launches planned in Q4/2015. Furthermore, a site-specific PEGylated rFVIII product currently being investigated may result in a significant benefit for long-term outcomes and quality of life improvements for people with hemophilia A. Today, prophylactic treatment for hemophilia patients makes it necessary that patients infuse themselves two to three times a week. The investigational product BAY 94-9027 is a long-acting factor VIII that is being studied in patients in a once-weekly prophylactic dosing regimen. Bayer HealthCare recently announced positive results with the site-specific PEGylated rFVIII product demonstrating protection from bleeds comparable to current prophylactic dose regimens with infusion intervals of up to seven days. Bayer is planning to file BAY 94-9027 for approval with the regulatory authorities in the second half of 2015. ]]> <![CDATA[GE launches new online magazine]]> https://biospectrumindia.com/news/95/3712/ge-launches-new-online-magazine.html https://biospectrumindia.com/news/95/3712/ge-launches-new-online-magazine.html Wed, 19 Mar 2014 15:43:00 +0530 The company's release said that the online magazine has been designed to appeal to broader range of audience, focusing on five key topics: Cancer, Neurology, Healthcare Innovation, and the Industrial Internet. The magazine will concentrate on the work GE Healthcare is involved in with the industry and other organizations, to help increase access, quality and affordability of healthcare. Graphically, this new online magazine will feature slideshows, and larger videos, and is said to be fully optimized and accessible on mobile devices. ]]> <![CDATA[Cervical cancer poses great threat to Indian women]]> https://biospectrumindia.com/features/95/3706/cervical-cancer-poses-great-threat-to-indian-women.html https://biospectrumindia.com/features/95/3706/cervical-cancer-poses-great-threat-to-indian-women.html Tue, 18 Mar 2014 16:14:00 +0530 In India, cervical cancer is amongst the top two causes of cancer mortality in women. 122,844 new cervical cancer cases are diagnosed annually in India and the country contributes 23% to the world incidence of cervical cancer. Annual number of new cervical cancer cases and death is maximum in the age group 45-59 years. Age-standardized incidence & mortality rates of cervical cancer are maximum in India as compared to other countries of Southern Asia. Moreover, over 80% of women newly diagnosed with cervical cancer live in developing countries; most are diagnosed when the disease is in the advance stage. Stressing on the need for the Indian women to undergo the regular checkups, Dr Anuj Goyal who is an expert in the area, told BioSpectrum in a recent interaction on the international women's day that the awareness too can play a vital role in ensuring lifestyle changes and need to undergo regular check ups. "There is a significant mortality rate that has been detected in the Indian women and that can be prevented provided there are regular check ups. The vaccination can also reduce the mortality rate by 95% and early stage chemotheraphy can also lower the chances," says Dr Goyal who has been works a consultant at various prestigious hospitals in Delhi. He feels that the area has been long ignored as there is no big scale government run programme to educate women. Dr Goyal also sought to dispel the myths surrounding cervical cancer.He mentions, "Lot of people link it to the hereditary problem which infact is not the case here. 90 % of the cases are due to the human papilloma virus (HPV). ]]> <![CDATA[BMS and Five Prime Therapeutics joins hands ]]> https://biospectrumindia.com/news/95/3709/bms-and-five-prime-therapeutics-joins-hands-.html https://biospectrumindia.com/news/95/3709/bms-and-five-prime-therapeutics-joins-hands-.html Tue, 18 Mar 2014 16:08:00 +0530 Five Prime Therapeutics, Inc. and Bristol-Myers Squibb Company have signed a collaboration agreement for the discovery, development and commercialization of immuno-oncology therapies directed toward targets identified in two undisclosed immune checkpoint pathways using Five Prime's proprietary target discovery platform. Bristol-Myers Squibb will leverage Five Prime's platform to advance its existing immuno-oncology programs by identifying the most viable drug targets for continued research and development. Drug candidates developed against these new and existing targets may be studied either as single agents or in combination with existing or potential Bristol-Myers Squibb immuno-oncology therapies. "Immuno-oncology has the potential to be transformational in the treatment of cancer, and Bristol-Myers Squibb has an extensive clinical pipeline and discovery programs dedicated to maximizing this field of research," said Francis Cuss, MB BChir, FRCP, executive vice president and chief scientific officer, Bristol-Myers Squibb. "Five Prime's innovative technology platforms complement our immuno-oncology pipeline and will help expand our understanding of promising new therapeutic options for patients." "We are thrilled to enter this important collaboration with Bristol-Myers Squibb, an undisputed leader in the exciting field of immuno-oncology," said Lewis T. "Rusty" Williams, M.D., Ph.D., president and chief executive officer of Five Prime. "This strategic alliance is evidence that our protein discovery platform is ideally suited to identify novel immune checkpoint targets for the development of next generation immuno-oncology therapeutics." Bristol-Myers Squibb will make an upfront payment of $20 million to Five Prime and provide up to $9.5 million in research funding over the course of the research term. Additionally, Bristol-Myers Squibb will make a payment of approximately $21 million to acquire 4.9% of Five Prime's outstanding common stock purchased at approximately a 30% premium. Five Prime will be eligible to receive up to $300 million in future development, regulatory and sales based milestone payments per collaboration target and tiered mid-single-digit rising to low-double-digit royalty payments on net sales of each product commercialized by Bristol-Myers Squibb. ]]> <![CDATA[FDI figures double for Indian pharma]]> https://biospectrumindia.com/news/95/3707/fdi-figures-double-for-indian-pharma.html https://biospectrumindia.com/news/95/3707/fdi-figures-double-for-indian-pharma.html Tue, 18 Mar 2014 16:00:00 +0530 Foreign Direct Investment (FDI) in the pharma sector has more than doubled to $1.26 billion during April-December of the ongoing fiscal year (2013-14) amid concerns over increasing acquisitions of domestic firms by multinationals. FDI in drugs and pharmaceuticals was at $589 million in the April-December for period of 2012-13, according to the latest data from the Department of Industrial Policy and Promotion (DIPP). Faced with a rush of multinationals to acquire Indian pharmaceutical companies, the Commerce and Industry Ministry had proposed tightening of norms for foreign investors in the existing firms, but the proposal was rejected by the Union Cabinet. The department had proposed the norms to arrest the spurt in pharma MNCs taking over domestic firms that make "rare and critical" medicines. As per estimates, over 96 per cent of the total FDI in the sector between April 2012 and April 2013 has come into brownfield (existing) pharma. The government had cleared Rs 5,168-crore proposal of US-based pharma firm Mylan Inc's to acquire Indian generic drugs company Agila Specialties. India allows 100 per cent FDI in pharma sector through automatic approval route in the new projects, but foreign investment in the existing companies are allowed only upon approval by the Foreign Investment Promotion Board (FIPB). Other sectors which received high FDI during the 9-month period of the current fiscal year include services ($1.59 billion), automobile ($871 million), construction ($914 million) and chemicals ($490 million). Overall, FDI into the country dropped 2 percent during the period to $16.56 billion. ]]> <![CDATA[AstraZeneca sells its Alderley Park site in UK]]> https://biospectrumindia.com/news/95/3708/astrazeneca-sells-its-alderley-park-site-in-uk.html https://biospectrumindia.com/news/95/3708/astrazeneca-sells-its-alderley-park-site-in-uk.html Tue, 18 Mar 2014 15:54:56 +0530 The sale is part of AstraZeneca's plan, set out in March 2013, to establish a new global R&D centre and corporate headquarters in Cambridge, UK, in 2016. Mr Pascal Soriot, CEO, AstraZeneca, said, "We believe that the sale of the site to Manchester Science Parks is the responsible and sustainable choice for the future of Alderley Park. The new owner is committed to building on AstraZeneca's life science legacy at the site and ensuring it remains a centre of biotechnology innovation in the North West of England. It will lead to future growth and offer significant opportunities for new jobs to be created." The new owners plan to build on Alderley Park's heritage of scientific innovation, ensuring that the 400 acre site remains a life science and biotechnology campus. The financial terms of the transaction are not disclosed. ]]> <![CDATA[India, Russia to cooperate on biotech research ]]> https://biospectrumindia.com/news/95/5898/india-russia-to-cooperate-on-biotech-research-.html https://biospectrumindia.com/news/95/5898/india-russia-to-cooperate-on-biotech-research-.html Tue, 18 Mar 2014 09:54:00 +0530 The joint research proposal in the area of biotechnology under the programme of cooperation (PoC) is between the Department of Biotechnology (DBT), Ministry of Science and Technology (MST), India and Russian Ministry of Education and Science (RMES). The objective is to broaden and deepen cooperation in Science & Technology in the field of biotechnology; to encourage industrial R&D and related investment flows, bilaterally and/or regionally in the field of Biotechnology and to promote transparency through exchange of information and cooperation among relevant institutions. In the area of biotechnology, the research areas to be given priority in the present call for proposal include the bio-energy, nano-biotechnology, bio-instrumentation, affordable Diagnostics for Human Health and Agriculture and affordable Devices for Human Health and Agriculture. As per the circular, the proposals submitted in other research areas will not be considered. The duration of a project will be three years initially. The Principal investigators from Universities and Research Institutions of each side who fulfill national eligibility rules for research grant application are eligible to apply. Only a Joint proposal having at least one Indian and Russian investigator will be accepted. For more information, one can have a look at DBT website. ]]> <![CDATA[India can't miss the opportunity ]]> https://biospectrumindia.com/features/95/3705/india-cant-miss-the-opportunity-.html https://biospectrumindia.com/features/95/3705/india-cant-miss-the-opportunity-.html Mon, 17 Mar 2014 17:29:49 +0530 The entrepreneurial ventures established by the first set of biotech entrepreneurs like Dr Kiran Mazumdar-Shaw, Dr Cyrus Poonawalla and Mr Soshil Kumar in the early 1980s to current set of entrepreneurs have pioneered several firsts and achieved significant mile- stones staying afloat in the harsh realities of non-availability of funds and wading through the rough waters with unique business models, creating their own niches. "We did not have a choice," said several of the early bio- tech entrepreneurs. Since there was no venture capital (VC), early start-ups had to focus on business revenues. They had to offer products and services. Then they set up manufacturing for today and set aside a sum of profits for tomorrow's products and services. Now they are considering to work on products for patients' today and tomorrow. The rise in generic business has led to adoption of innovation and R&D in India. The second set of entrepreneurs like Dr Krishna Ella of Bharat Biotech, Mr Varaprasad Reddy of Shantha Biotechnics, Dr KK Narayanan of MetaHelix, Dr Vijay Chandru of Strand Life Sciences, and Dr Ravi Kumar of Xcyton reminiscence that it was difficult to create an innovation culture or platform without sustainable revenues. Some of them now recommend or ask to put all the profits from products into innovation. "Do not put back all revenues in shareholder's hands but in R&D," they caution. The current set of enterprises that have been launched in the last three-to-four years are working on innovation-driven platform technologies and most of these enterprises are coming through a VC generation. Investors have backed the model. They need to raise more rounds. And they believe that it's equally important to have government intervention. "In 2006, we had a choice to go for debt or VC. We chose to focus on revenue first through services," pointed out Mr Ajay Bharadwaj of Anthem Biosciences. The focus now is on partnerships with others to launch products. Sharing the costs and risks in novel therapeutics is beneficial with both. VCs have not yet invested heavily in Indian biotech yet and there is lack of confidence in the investor community about the climate in India and the capabilities of the entrepreneurs in India. The reality is that India has done well and has a unique and interesting model that have proven to succeed. It is attractive because the start- ups here have taken low-medium risk and they already have products or revenues, and some of them are even profitable. What is also very interesting is that the Indian government is seeding the ecosystem for biotech and multiple venture capital firms through BIRAC in order to increase the levels of innovation, increase entrepreneurial zeal, industry- academia interface, and support funding and mentoring. This kind of an ecosystem is unparalleled in India. And it is time that the investors' confidence is restored with better awareness and meaningful discussions. According to Mr Venkatadri Bobba, general partner, Ventureast Fund Advisors India, the best is yet to come for BioPharma as there are no clear drug products from the Human Genome Project as yet and there are no clear therapeutic path to individual genomic-based pharmacotherapy. The playbook for India will be to enhance skills, leverage global expertise through partnerships, focus on biosimilars, bio-betters, or validated targets and plan for success and failure. ]]> <![CDATA[SC Johnson launches initiative to combat mosquito-borne diseases]]> https://biospectrumindia.com/news/95/3703/sc-johnson-launches-initiative-to-combat-mosquito-borne-diseases.html https://biospectrumindia.com/news/95/3703/sc-johnson-launches-initiative-to-combat-mosquito-borne-diseases.html Sat, 15 Mar 2014 09:12:00 +0530 Mosquito-borne diseases, such as dengue and malaria, affect millions of adults and children globally each year. According to the World Health Organization (WHO), the incidence of dengue has increased 30-fold in the past 50 years. SC Johnson, the global leader in pest control, recognizes the need to address this threat and has expanded its commitment to disease prevention with programming efforts this year in India, Malaysia, Indonesia, Brazil, the Philippines, Mexico, Costa Rica and Vietnam. Through a mix of grassroots education and powerful partnerships with local nongovernmental organizations (NGOs), SC Johnson teams have engaged local communities to help fight the spread of dengue and malaria by inspiring people to take action against the issue. "SC Johnson is committed to disease prevention and to helping families fight dengue and malaria," said Mr Kelly M Semrau, senior vice president - Global Corporate Affairs, Communication & Sustainability for SC Johnson. "As a global citizen and expert in pest control products, we have a responsibility to play a key role in increasing awareness of these diseases in communities around the world and providing access to quality education resources." Several markets, including Indonesia, Malaysia and the Philippines, have enacted successful disease prevention campaigns over the past several years. In 2013, the company implemented a global campaign. "Fight Dengue for Your Family" is a global program that serves as a call-to-action, motivating families to take precautionary measures on disease prevention and to make a difference in the lives of children. Payal Samariya, a 12-year-old student who saw her friend suffer with dengue, served as the face and hero of the campaign. The program focused on dengue awareness efforts throughout India with the help of the Voluntary Health Association of India (VHAI), a non-profit organization that links more than 4,500 health and developmental organizations across the country. "We are happy to be a part of this program, an awareness campaign in association with SC Johnson," said Ms B Mukhopadhyay, executive director, VHAI. "Payal represents the millions of children and families in India who are susceptible to the dangers of mosquito-borne diseases." ]]> <![CDATA[ Around 58,656 bottles of lansoprazole drug in US recalled]]> https://biospectrumindia.com/news/95/3702/-around-58656-bottles-of-lansoprazole-drug-in-us-recalled.html https://biospectrumindia.com/news/95/3702/-around-58656-bottles-of-lansoprazole-drug-in-us-recalled.html Fri, 14 Mar 2014 17:48:00 +0530 Dr Reddys Laboratories is recalling about 58,656 bottles of the heartburn drug lansoprazole in the US due to a microbial contamination, according to reports. Report said that this move comes amid a string of quality problems for Indian drugmakers.While product recalls are not uncommon, the FDA announcement comes amid a string of quality problems for Indian drugmakers. Earlier report said that US regulator also announced it was banning imports from Sun Pharmaceutical Industries Ltd, Karkhadi manufacturing plant in the western state of Gujarat. Dr Reddy's voluntary recall of lansoprazole delayed release capsules, a generic version of Swiss drugmaker Novartis' drug Prevacid 24 HR, began on January 3, 2014. Previous this week, Sun Pharma had voluntarily recalled 2,528 bottles of its generic version of diabetes drug Glumetza in the US market on the basis of a customer complaint. Among others, some plants of Ranbaxy and Wockhardt have already been banned from importing drugs into the US market. Whereas all plants of Daiichi Sankyo controlled Ranbaxy Laboratories in India have been banned from exporting drugs to the US, Wockhardt has also faced similar actions on its two plants in the country. Dr Reddy's Laboratories shares today closed at Rs 2,734.15 on the BSE, up 1.63 percent from its previous close. ]]> <![CDATA['Nurturing the seeds of innovation']]> https://biospectrumindia.com/features/95/6406/nurturing-the-seeds-of-innovation.html https://biospectrumindia.com/features/95/6406/nurturing-the-seeds-of-innovation.html Fri, 14 Mar 2014 15:43:00 +0530 The idea behind the setting up of BIRAC was of promoting the innovation in research development through entrepreneurship and public private partnerships. This government of India enterprise, is a new industry-academia interface and implements its mandate through a wide range of impact initiatives, be it providing access to risk capital through targeted funding, technology transfer, intellectual property management and handholding schemes that help bring innovation excellence to the biotech firms and make them globally competitive. During its first year of existence after being incorporated on March 20, 2012 as a section 25, not for profit company, BIRAC has initiated several schemes, networks and platforms that help to bridge the existing gaps in the industry-academia innovation research and facilitate novel, high quality affordable products development through cutting edge technologies. The unique government enterprise has initiated partnerships with several national and global partners to collaborate and deliver the salient features of its mandate. The existing schemes that are being driven by BIRAC include Biotechnology Industry Partnership Programme (BIPP) and Small Business Innovation Research Initiative (SBIRI). Apart from the existing schemes, the launch of new scheme, signing of more than 100 public private partnership research agreements, supporting nearly 50 industry-academia partnership collaborations and technology acquisition for nutritional crop improvement. The Biotechnology Ignition Grant (BIG) scheme was announced in June 2012 in partnership with 3 partners IKP Knowledge Park, Hyderabad; for Cellular and Molecular Platforms (C-CAMP), Bangalore and Foundation for Innovation and Technology Transfer (FIIT), New Delhi Provides support of `50 lakh (US $100,000) for high risk innovation discovery and proof of concept by first generation entrepreneurs and early start ups. The Contract Research Scheme (CRS) was announced to promote academia - industry interface; 3 calls were launched; 84 proposals were received; 88 academic and 83 industry partners are involved; 7 proposals were approved; 9 academic and 7 industry partners are involved. BIRAC and Centre of Entrepreneurial Learning (CfEL) of Judge Business School, University of Cambridge have initiated a partnership that enables 5 BIRAC supported applicants to take part in CfEL's flagship intensive entrepreneurial boot-camp programme called "IGNITE", which is aimed at providing scientists and early start ups to explore entrepreneurial opportunities of their innovative ideas and transform them into a business project. In the year 2013, BIRAC selected 5 candidates from BIG grantees and Stanford India Biodesign (SIB) fellows, for the programme. Dr K Vijay Raghavan, secretary, DBT while speaking at an event in New Delhi called the BIRAC as a stimulating partner for innovation. He also emphasized on the role of BIRAC as an organization to promote entrepreneurship across almost all the life science verticals. "BIRAC is a stimulating new avenue of entrepreneurship, both in partnership with industry as well as the academia. It has a much bigger role to play ensure the affordability of healthcare and it is now also gearing up on the manufacturing sector as well," remarked Dr Raghavan who is also the chairman of BIRAC. In alignment with its long term plan of entering into international partnerships, BIRAC has recently entered into collaboration with the CEFIPRA (Indo French Centre for the Promotion of Advanced Research) to support Indian and French biotech start-ups and SMEs for promoting the innovation ecosystem in both the countries. The partnership aims to improve the competitiveness of both Indian and French biotech industries. In this collaboration, BIRAC will support Indian industries, whereas CEFIPRA will mobilise support for French industries. The initial focus of the collaboration will be on interventions in red and green biotechnology. Apart from that it has already forged international linkages such as the DBT-BIRAC-GATES Foundation partnership which is for affordable product development in healthcare and agriculture. BIRAC has set up a project management unit (PMU) to take this partnership forward and implement the agreed action plan. Another is BIRAC-DBT-WHO-PATH multi-stakeholder consortium on affordable technologies for women and child is also underway. The discussion was organized and 8 priority technologies identified for future activities. The details are being worked out. Not remaining behind in its social responsibilities, the BIRAC also has launched the Social Innovation Programme for Products Affordable and Relevant to Societal Health (SPARSH. The idea is to promote the innovative biotechnology tools to bring in solutions for maternal and child health issues. The first call for it was launched in September 2013 and it was intended to bring the like-minded private and public sector companies together to implement World Health Organizations's (WHO) millennium goals. Apart from that BIRAC has also launched the unique 'Reinvent the toilet challenge' in partnership with the Bill and Melinda Gates Foundation to bring in new technologies to improve sanitation. The BIRAC is also leveraging existing strengths by building partnerships. It has tied up with the Association of Biotechnology Led Enterprises (ABLE) as a knowledge partner and Clinical Development Services Agency (CDSA) for clinical trial related activities. These efforts are in tune with the long term goal of a US $100 billion biotech Industry by 2025 and create a true Indian bio-economy. Special emphasis on empowerment of researchers, start ups and SME's : â€¢ Foster innovation and entrepreneurship in all places of researchâ€¢ Promote affordable innovation in key social sectors â€¢ Higher focus on start ups, small and medium enterprisesâ€¢ Contribute through partners for capability enhancementâ€¢ Encourage diffusion of innovation through partnersâ€¢ Enable commercialization of discoveryâ€¢ Ensure global competitiveness of Indian enterprises. Few initiatives that BIRAC is planning to launch in the future: â– BIRAC Social Innovation in biotechnology To address the increasing public interest in biotechnology, this initiative will focus on the deliverables as a sector to find solutions and addressing the problem of society at large. Cutting edge technology, novel process and products need more focussed attention in the context of affordable product development for societal benefit. BIRAC is envisaging a Social Innovation scheme that is focused on finding solutions to multitude of issues in this arena. â– BIRAC Industry Sponsored Research (BISR) BISR is an initiative that hopes to bring industry and academia together in a manner that academia (or a consortia of academic partners) helps in delivering products (that have an economic and environmental benefit) through R&D conducted in academia that is sponsored jointly by the industry and BIRAC. â– BIRAC Grand Challenges in Healthcare and Agriculture, Food & Nutrition Mission mode approaches in several sectors including biotechnology have been one of the preferred means for creating impact as exemplified by "grand challenges" schemes that are implemented by Bill & Melinda Gates Foundation and Grand Challenges Canada. It is BIRAC's intention to launch the "Grand Challenges programme" especially relating to "Securing Family Health" and "Agriculture, Food & Nutrition"-in partnership with BMGF, and other like-minded philanthropies organization. â– BIRAC Translation Facilities BIRAC would considering setting up of Facilities for Translational Research in partnership and co-governance models of operation. Based on earlier discussion and suggestion received from Experts and researchers, a discussion note has been prepared for consideration. ]]> <![CDATA[India's Sun Pharma hit by USFDA ban]]> https://biospectrumindia.com/news/95/3710/indias-sun-pharma-hit-by-usfda-ban.html https://biospectrumindia.com/news/95/3710/indias-sun-pharma-hit-by-usfda-ban.html Fri, 14 Mar 2014 12:00:00 +0530 The US Food and Drug Administration (FDA) has imposed a ban on imports from generic drugmaker Sun Pharmaceutical Industries plant at Karkhadi in Gujarat, in the latest quality blow for the country's drug sector. The shares of country's biggest drugmaker by value Sun Pharma, sharply fell by a margin of 6.4 percent on Thursday after the FDA's "import alert", which appeared on Wednesday on the agency's website. The Karkhadi plant makes both drug ingredients and formulations, according to Sun Pharma 2013 annual report. The FDA action against Sun Pharma comes amid a rash of regulatory sanctions against Indian generic makers in the last year, triggering concerns about the quality of the medicines supplied by India's $14 billion drug industry to countries including the US, the biggest market. The FDA has also banned all the India plants of Ranbaxy Laboratories. ]]> <![CDATA[11 Hot Biotech Start-ups]]> https://biospectrumindia.com/features/95/3699/11-hot-biotech-start-ups.html https://biospectrumindia.com/features/95/3699/11-hot-biotech-start-ups.html Fri, 14 Mar 2014 00:05:00 +0530 ]]> <![CDATA[New technology helps unconventional way of recording heart beats]]> https://biospectrumindia.com/news/95/3696/new-technology-helps-unconventional-way-of-recording-heart-beats.html https://biospectrumindia.com/news/95/3696/new-technology-helps-unconventional-way-of-recording-heart-beats.html Thu, 13 Mar 2014 15:16:00 +0530 Ever wondered if you have ever felt transient dizziness or palpitations with sudden unexplained fainting or loss of consciousness? Most of the times it is assumed to be a temporary condition of weakness due to improper diet, lack of sleep or over exerted stress on a human body. While at some times it might stand true, but not always. It could be something way graver. The primary cause for these unexplained fainting and dizziness episodes could sometimes be also related to your heart conditions and you could be suffering from slow or extra fast heart rhythms, termed as arrhythmia in medical terms. Arrhythmia refers to abnormal rhythms of the heart which in turn causes the heart to pump blood less effectively. Most cardiac arrhythmias are temporary and benign, however there are some that are life threatening and require to be attended seriously. The common symptoms of cardiac arrhythmia are dizziness, shortness of breath, lightheadedness, rapid heartbeat, heart palpitations, chest pain, blackouts, visual problems, and fainting. However different patients suffer from these symptoms at different frequencies. Patients with infrequent short-duration transient symptoms, recurring over weeks or months, are unlikely to be diagnosed by the conventional Holter monitoring that monitors the heart for 24-48 hours, or an ECG since the likelihood of symptom-ECG correlation is very low. The above mentioned tests allow the doctor to look at the heart's activity at rest and at one point in time. But abnormal heart rhythms and cardiac symptoms may come and go. So to record your heart rate and rhythm during a symptom there is a device called as the External Loop Recorder (ELR). An ELR has capability to monitor a patient's heart for a long duration (7-30 days), and hence has a higher chance of providing a diagnosis to patients with infrequent symptoms. An ELR has emerged as the next big leap in medical technology by making a detailed monitoring of your heart conditions over a period of time easy and convenient like never before, making a headway to living rooms and reachingwithin the access of a patient's fingertips. This FDA approved and CE marked External Loop Recorder (ELR) System is an extremely patient friendly device and presents a comprehensive solution for apt detection and analysis of cardiac arrhythmias. While continuously keeping a track of heart activity and detecting both symptomatic and asymptomatic cardiac abnormalities, it even enables symptomatic patients record high definition ECGs. The devices are generally placed on the patient's skin in the chest region. They are generally auto-triggered and some advanced ones even enable patient activation capability through a patient trigger magnet. Allowing monitoring from the comfort and ease of your home, an ELR records arrhythmia episodes and wirelessly transmits them to the z-link monitor placed on the to the patient's belt.This z-link then relays the recorded episodes to an ECG Monitoring Centre over a cellular network. At the end of the prescription, a monitoring center, staffed by qualifiedcardiographic technicians, sends the diagnostic reports to the physician via email. The diagnostic report consists of an average daily heart rate graph, a summary of the reported arrhythmias and the ECGs. If the arrhythmia qualifies as one of high importance, an urgent report is sent to the physician within a fewhours. The physician has the option of requesting a complete 45 second ECG (15 seconds before the trigger and 30 seconds after), otherwise a 6 second representative sample is provided. An ELR, with its capability to monitor a patient for a long duration (7-30days) has a higher chance of providing a diagnosis to patients with infrequent symptoms (symptom occurs at least once a month) and hence enable better treatment, also acting as a viable tool for preventing serious conditions from escalating. ]]> <![CDATA[Ten million Indians living with sleep disorders: Study]]> https://biospectrumindia.com/news/95/5565/ten-million-indians-living-with-sleep-disorders-study.html https://biospectrumindia.com/news/95/5565/ten-million-indians-living-with-sleep-disorders-study.html Thu, 13 Mar 2014 15:12:13 +0530 With March 14 being celebrated as World Sleep Day, Philips Healthcare India announced plans to organize over 300 sleep-focused awareness events and to train over 500 physicians in dealing with sleep disorders in 2014. In 2013, the company conducted over 200 sleep focused events and trained over 300 technicians and 600 physicians to meet the demand for trained sleep specialists. It has also introduced the first certificate training program for physicians under the banner of Indian Sleep Disorder Association. "Sleep disorders are a much more serious issue than most people understand, especially given their direct correlation with other more serious conditions like cardiovascular disease, diabetes, stroke etc. For example, in a country where snoring is traditionally associated with sound sleep, it is extremely challenging to make people aware that it is actually a sign of a serious sleep disorder called Obstructive Sleep Apnea (OSA)," said Mr Bidur Dhaul, senior director, Home Health Care, Philips Healthcare India. According to international studies, OSA sufferers are between four and six times more likely to be involved in a motor vehicle accidents than healthy people. The lack of sleep can also lead to serious health issues such as increased risk of diabetes, weight gain, high blood pressure, irregular heartbeats and stroke among others Dr Prashant Chhajed, director, lung care and sleep center, Mumbai & Senior Chest consultant, Lilavati and Fortis Hospital, Mumbai, New Delhi, says, "Treating OSA will help you witness immediate relief from symptoms like daytime sleepiness, extreme fatigue thereby resulting in improved energy levels across the day. As per various researches, it can also lower blood pressure, decrease insulin resistance and lower the risk of heart attack and stroke when treated with CPAP therapy." According to industry estimates, today there are at least 10 million Indians living with different types of sleep disorders, with OSA being the most common. Sleep Apnea is also one of the top 3 causes of heart problem after smoking and diabetes. Snoring, the most visible and harmless looking symptom of OSA, is also the root cause of high blood pressure and diabetes, as discovered by experts. Studies suggest that 37-51% of obese patients, 37% of Hypertensive patients, 48% of Diabetes patients and 76% of Congestive Heart Failure patients are also found to be suffering from OSA. From recent Philips Sleep Survey, conducted by The Nielsen Company in India, 93% Indians are sleep-deprived, getting less than the 8 hours of sleep they need every day. An astonishing 11% take leave from work because of lack of sleep. The Survey also reveals that 58% feel that their work suffers from lack of adequate sleep while 11% actually fall asleep at work. The survey also uncovered a disturbing fact that 14% of Indians exhibit pauses in their breathing at night, anywhere from one to more than three times per week. Pausing in breathing, like snoring, is an OSA indicator, corroborating this link; the survey found that the proportion of the high risk group increased further to 90 % in those suffering from hypertension and diabetes or hypertension and cardiovascular disease. One of the main treatment options for OSA is Continuous Positive Airway Pressure (CPAP). CPAP therapy provides a gentle flow of pressurized air through the nose and/or mouth using a mask. The air pressure prevents the narrowing and closure of the upper airway, allowing the patient to breathe freely during sleep. CPAP therapy has been shown to improve the patient's quality of life, reduce the short and long term health consequences and save on healthcare related costs. This therapy can display a dramatic decrease in the patient's feeling of sleepiness in as little as two weeks. ]]> <![CDATA[Dr Prathap Reddy is a man on a mission: Dr Kiran Mazumdar-Shaw]]> https://biospectrumindia.com/features/95/3697/dr-prathap-reddy-is-a-man-on-a-mission-dr-kiran-mazumdar-shaw.html https://biospectrumindia.com/features/95/3697/dr-prathap-reddy-is-a-man-on-a-mission-dr-kiran-mazumdar-shaw.html Thu, 13 Mar 2014 14:58:00 +0530 The book was released in the presence of distinguished luminaries including Dr Devi Shetty, chairman, Narayana Health and Dr Kiran Mazumdar-Shaw, CMD, Biocon. Two years in the making, and penned by former New York Times journalist, Mr Pranay Gupte, read the epilogue and a short passage from the newly unveiled book. Later he was felicitated by Dr Reddy himself. In his note, Dr Reddy opined, "What she (Dr Kiran Mazumdar) has done is outstanding and remarkable... We need to focus on the need to bring in the change... The world is going to lose 36 million people every year to non-communicable diseases... It is a crime to not to take care of yourself... When you set yourself with a purpose, nothing can stand against you..." The 'HEALER' engages its readers with the biography of Dr Prathap Reddy, containing stories of his accomplishments, and traces his unbelievable journey from a small provincial town in Andhra Pradesh to Stanley Medical School, and his phenomenal success as a practicing cardiologist in the US, and his return to India at the age of 50, to bring medical care at par with the best. In her applauded speech, Dr Kiran Mazumdar-Shaw said, "India is a very young nation. We have a number of pioneers who are nation builders, who have a sense of purpose coupled with a spirit of challenge, because India is not an easy country to pioneer in." "He (Dr Reddy) is a man on a mission. He was the one who looked at Indian healthcare in a different way. Every pioneer looks at a challenge as an opportunity. Dr Prathap stands for professionalizing healthcare and making passionate business model. He has shown the way to the rest of the healthcare industry in terms of what can be done to make a difference. He transformed the healthcare landscape in India," expressed Dr Kiran. Dr Kiran also shared that the government should ensure that every Indian has the right to healthcare, which is seen to be the next big challenge. In several instances, the book also recalls the state of affairs of Indian healthcare sector in the last forty years, oven along with mammoth challenges faced by Dr Reddy during his journey. In the book, Mr Gupte has also incorporated several interesting anecdotal stories, and twists and turns, narrating Dr Reddy's life story in a dramatic way. Dr Kiran concluded by adding, "Dr Reddy's rich legacy are his daughters. His wife has been a great pillar of support for the whole family. Here is a man that we salute with great admiration and gratitude. Thanks to you Dr Reddy, because this country is a better place now." Priced at INR 899.00, HEALER is available at leading bookstores, and also in shopping portals and online bookstores. Product details:HardcoverPublisher: Portfolio (2013)Language: EnglishISBN-10: 0670086800ISBN-13: 978-0670086801 ]]> <![CDATA[PHFI report recommends amends to current medical education policy]]> https://biospectrumindia.com/reports-white-papers/95/3701/phfi-report-recommends-amends-to-current-medical-education-policy.html https://biospectrumindia.com/reports-white-papers/95/3701/phfi-report-recommends-amends-to-current-medical-education-policy.html Thu, 13 Mar 2014 13:55:00 +0530 The National Board of Examinations (NBE) and Public Health Foundation of India (PHFI) on March 12, 2014 released the first of its kind report of Health Professional Education for a New Century. The report was unveiled by Mr CK Mishra additional secretary, ministry of health and family welfare, Dr K Srinath Reddy, president PHFI and NBE and Prof M C Misra, director, AIIMS, New Delhi. The report is a compilation on "5 Country Network Study-Situational Analysis of Health Professionals Education". The 5-Country Network comprising of Bangladesh, China, India, Thailand and Vietnam jointly undertook an extensive collaborative exercise to undertake this situational analysis. The India specific activities under this project were jointly led by the Public Health Foundation of India (PHFI) in partnership with the National Board of Examinations (NBE), from its conceptualization till its completion. During the period 2011-2013 the National Board of Examinations and Public Health Foundation of India undertook an in-depth situation analysis for health professional education in composing medical education, nursing education and public health education through various scientific tools and deliberations with other distinguished participants from the Asia-Pacific network on Health Professional Education for Reforms (ANHER). The symposium also focused on the placement of Foreign Medical Graduates in the Indian mainstream medical education, making it more competitive. Among the six key recommendations, the report has suggested that the councils for medical and nursing professions should proactively engage with all concerned stakeholders to advance the reforms agenda. Accreditation mechanisms for institutions and educational programmes should be pursued. Currently there is no accreditation mechanism available for Public Health Education. The Ministry of Health and Family Welfare should take the lead to establish the architecture for accreditation for Public Health Education. It has also recommended that the inter-professional educational settings are an imperative and should be reflected in the instructional settings within institutes. This is possible only in those settings which encourage team-work as an integral value. Educational institutes should also be encouraged to partner with other institutes/ organizations/ NGOs and health systems to foster systems thinking as a core. ]]> <![CDATA[Jubilant announces 18% price hike for Niacin]]> https://biospectrumindia.com/news/95/3711/jubilant-announces-18-price-hike-for-niacin.html https://biospectrumindia.com/news/95/3711/jubilant-announces-18-price-hike-for-niacin.html Thu, 13 Mar 2014 13:48:00 +0530 Jubilant Life Sciences, a significant player in the Nutrition market and ranked amongst the largest manufacturers of Vitamin B3 (Niacin & Niacinamide) in the world on March 13, 2014 announced a price-increase of 18% for Niacin feed-grade, with immediate effect, for non-contract customers and wherever existing contracts permit. As per the company's statement, it delivers unmatched advantages of consistent quality and availability of Vitamin B3 (Niacin & Niacinamide) to its customers globally. The company's nutrition business is backward integrated up to the initial raw material stage with global scale of operations. ]]> <![CDATA[DHR invites suggestions for fresh approach on health issues]]> https://biospectrumindia.com/news/95/3695/dhr-invites-suggestions-for-fresh-approach-on-health-issues.html https://biospectrumindia.com/news/95/3695/dhr-invites-suggestions-for-fresh-approach-on-health-issues.html Thu, 13 Mar 2014 13:40:51 +0530 The Department of Health Research is proposing to set up of a Medical Technology Assessment Board (MTAB) for the evaluation on the appropriateness and cost-effectiveness of medical technologies, interventions and procedures for introduction/procurement for introduction into the public health system (central/state) of India in the short/medium/longterm. The proposed methodology includes extracting available evidence and gather other relevant data/information available in the public domain, discussion with all stakeholders and finally evaluation by expert group(s). Suggestions are invited on identifying top health problems of widest national importance so that technologies, drugs, diagnostics, devises, health interventions etc. related to them may be focused on priority that are critical for providing affordable health care. A consolidated list compiled with inputs from all stakeholders will be examined by a group of experts for identifying top ten public health problems on which guidelines for appropriate use of technologies/drugs/vaccines are needed for the country. The overall objective of this endeavour is to devise a robust system for generating credible evidence on the available/new health products and other interventions for their cost effectiveness/appropriateness for use in the public health system in India. The suggestion (not exceed 300 words) may be sent by mail /uploaded at htab@icmr.org.in on or before March 31,.2014. ]]> <![CDATA[Over 200 Indian districts facing high malnutrition rates: Prof M S Swaminathan]]> https://biospectrumindia.com/features/95/7759/over-200-indian-districts-facing-high-malnutrition-rates-prof-m-s-swaminathan.html https://biospectrumindia.com/features/95/7759/over-200-indian-districts-facing-high-malnutrition-rates-prof-m-s-swaminathan.html Thu, 13 Mar 2014 13:40:00 +0530 The summit was also joined by Shri Dinesh Gundu Rao, Hon'ble Minister of State for Food and Civil Supplies and Consumer Affairs Department, Government of Karnataka. Shining with the theme, 'New Sutra for Nutra for Emerging Global Economics', the event is a flagship happening in the nutrition, nutraceuticals, functional foods & dietary supplements industry, organized by MM Activ Sci-Tech Communications and International Society for Nutraceuticals, Nutritionals and Naturals (ISNNaN) and supported by international associations like IUFoST and IFT. In his exclusive presentation titled, 'Nutraceutical Science and Achieving the Zero Hunger Challenge', Prof M S Swaminathan said, "Indian population is dependent on agriculture. According to UNICEF, 39% of the children are starved in South Asia." "There are 200 districts in India alone which has very high malnutrition rates," he emphasized. He further added, "There are three dimensions to hunger: Calorie deprivation, protein deficiency and micro-nutrients deficiency." Post the inaugural, Prof Swaminathan was felicitated with the 9th Nutra India Life Time Achievement Award by Shri Dinesh G Rao. The inaugural host, Dr V Prakash, scientist, CSIR-India, & VP, International Union of Nutritional Science (IUNS) quoted, "We cannot forget nutrition. When there is a delay in the production of food products, it is because the investments now have significantly dropped. However, we have huge amount of money. This industry is worth $300 billion market and it is a great opportunity for India, China, Vietnam, Thailand, Taiwan and other countries to marry science and evidence." The guest of honor, Dr G Thyagarajan, FRSC, former director, CSIR Laboratories & former scientific secretary, COSTED, held that the nutraceutical industry is a fast expanding sector with immense scope and possibilities. "When we expand fast, we tend to make mistakes. We have to be careful to see that the nutra sector is carefully dealt and taken forward." He also said that the nutra sector is ideal for formulating global research alliances. "The global research alliance for nutra development can provide intermediate platform, and this sector have to move on its own strength," he opined. Shri Gundu Rao in his speech expressed, "We have issues of malnutrition, under-nutrition, and under-weight problems among women especially. The focus that we need in this field will be enhanced through this event." ]]> <![CDATA[ Quintiles as 'Best CRO in Asia']]> https://biospectrumindia.com/news/95/3694/-quintiles-as-best-cro-in-asia.html https://biospectrumindia.com/news/95/3694/-quintiles-as-best-cro-in-asia.html Wed, 12 Mar 2014 18:16:00 +0530 Quintiles was named the "Best CRO in Asia" at the 2014 BioPharma Asia Industry Awards, the third time in the event's four-year history that Quintiles has received the honor. The award recognizes the contract research organization that has best demonstrated an ongoing commitment to improve clinical research in Asia and help customers succeed. "For 20 years we've been helping our customers navigate Asia's complex and changing healthcare environment. It's wonderful to be acknowledged for our excellence in bringing knowledge and people together for a healthier world" expressed Mr Ken Lee, MD, Quintiles vice president and regional general manager for Southeast Asia, who accepted the award. In the last two years, Quintiles has continued to expand its integrated services in Asia-Pacific, including, launching a late phase research offering, real world and late phase research, to help companies, governments and payers determine the value of new medicines in real-world use. And also Significantly expanding its local CRO in China, Kun Tuo, which complements its global offering through Quintiles China. while adding anatomic pathology, genomics and flow cytometry testing capabilities to its central laboratories in Singapore, Beijing, Tokyo and India. Mr Anand Tharmaratnam, MD, Quintiles senior vice president and head of Asia-Pacific, said, "I'd like to dedicate to this to our employees, whose excellence made it possible; to our valued customers; and to patients worldwide whose lives and quality of life depend on new and better medicines." ]]> <![CDATA[Mylan enters into India's critical care segment market]]> https://biospectrumindia.com/news/95/4090/mylan-enters-into-indias-critical-care-segment-market.html https://biospectrumindia.com/news/95/4090/mylan-enters-into-indias-critical-care-segment-market.html Wed, 12 Mar 2014 15:00:49 +0530 Mylan Inc, one of the world's leading generic and specialty pharmaceutical companies, today announced that its subsidiary, Mylan Pharmaceuticals, has launched a Critical Care segment in India. The new segment focuses on anti-fungal, antibiotics and anti-coagulant therapies. AmBisome, a leading anti-fungal, is one of the first critical care products Mylan is offering. "The introduction of Mylan's Critical Care segment represents another milestone in the expansion of our commercial presence in India and supports our mission to expand access to high quality medicine around the world. Moreover, the Critical Care segment allows us to better satisfy the unmet medical needs of patients living with life-threatening diseases. The bacterial disease burden in India is among the highest in the world2 and as a result, critical care medicines play an increasingly important role in limiting morbidity and mortality" said Ms Heather Bresch, CEO Mylan. Ms Bresch continued, "As an indicator of disease burden, pneumonia causes an estimated 410,000 deaths in India each year.2 Many of these deaths occur because patients do not have access to life-saving antibiotics. We look forward to playing a central role in expanding access to affordable, quality medicine that these individuals desperately need." AmBisome treats life-threatening, systemic fungal infections and the parasitic disease visceral leishmaniasis. The product is the innovator brand of Liposomal Amphotericin B and is widely accepted by hematologists, oncologists and intensivists for the treatment of suspected or definitive systemic fungal infections. Mr Rajiv Malik, president Mylan added, "This new segment further diversifies our product offerings in India. In the past 18 months alone, we have delivered on our commitment to providing high quality medicine to patients in India through the introduction of four unique and innovative segments - Antiretroviral, Women's Care, Oncology and, now, Critical Care. " ]]> <![CDATA['We do not want to conduct clinical trials in India']]> https://biospectrumindia.com/news/95/7659/we-do-not-want-to-conduct-clinical-trials-in-india.html https://biospectrumindia.com/news/95/7659/we-do-not-want-to-conduct-clinical-trials-in-india.html Tue, 11 Mar 2014 17:14:00 +0530 "We do not want to conduct any clinical trials in India as the Indian government has imposed unreasonable regulations pertaining to compensating both - patients and their families, in the event of an adverse effect as a result of the trial," said the medical-entrepreneur, Dr Natarajan Ranganathan, MD of the US-based biotech company, Kibow, during the launch of their product 'Renadyl', here in Bangalore on March 11, 2014.Dr Ranganathan said that each bottle will be sold at Rs 2500 in India as a launch offer. However, he refused to comment on the pharma companies with whom Kibow is seeking to collaborate. Renadyl is manufactured externally by a contract research organization, said the MD, as they do not have a manufacturing base in India. It was also emphasized that the product is not a substitute for dialysis. Kibow biotech, launched in 1997, is exclusively carrying out R&D and quality controlling alone at its Pennsylvanian lab. According to Dr Ranganathan, the company was started originally as a drug development company. The clinical trials for this product was carried out in USA, Canada, Argentina and Nigeria. In his presentation, Dr Ranganathan said that the acute kidney failure is reversible and can be caused due to sudden trauma, accident or toxicity. However, the irreversible chronic failure can be as a result of hypertension, diabetes, CVDs, TB or even HIV. "More than 50% of kidney function loss cases either have to opt for dialysis or transplantation," added Dr Ranganathan. Talking about the product, he opined, "We wanted to take a bacteria and clone it with different genes and introduce it in the human colon, which will be able to metabolize uremic toxins. It was a humongous challenge to take our product through the US FDA." Dr Ranganathan also recalled that, there are about 5000 clinical trials going on in the US and only a mere 25-30 products are approved by the US FDA. Dr Mahesh Rangan, son of Dr Ranganathan and Kibow's international product manager added that the company is now having active discussions with Indian companies to co-market their product and making it available through a joint-venture partnership very soon this year. "We will manufacture Renadyl in India depending on the need. We are open to investments. We now want to get in to India and increase our revenues," he expressed. He further added, "We can't target the market segment. We look forward for mass dispersal through NGOs or organizations willing to subsidize the product for mass appeal to address the issue of affordability among Indian patients. But right now our target is middle and upper-class masses." ]]> <![CDATA[Sanofi, UCB enter into a pact ]]> https://biospectrumindia.com/news/95/3689/sanofi-ucb-enter-into-a-pact-.html https://biospectrumindia.com/news/95/3689/sanofi-ucb-enter-into-a-pact-.html Tue, 11 Mar 2014 16:59:05 +0530 Sanofi and UCB have entered into a scientific and strategic collaboration for the discovery and development of innovative anti-inflammatory small molecules, which have the potential to treat a wide range of immune-mediated diseases in areas such as gastroenterology and arthritis. According to Dr Elias Zerhouni, president, global R&D, Sanofi, immune-mediated diseases affect individuals, families, and communities and impact the economies of countries and nations, making this poorly understood category of diseases a significant public health burden. "Joining efforts with UCB, will address a scientific challenge in immunology, and increase the chances of accelerating the discovery and development of future therapies", adds Zerhouni. UCB New Medicines, the research arm of UCB, has used an innovative approach to identify small molecules modulators of a biological pathway, for which parentally administered biologic therapies have proven highly efficacious in patients. A dedicated team of scientists will be formed under the leadership of Sanofi and UCB, and will join forces in a discovery and development based collaboration to characterize and identify new potential therapies. "We partner Sanofi's significant expertise, strong capabilities and resources with UCB's cutting-edge research skills and breakthrough innovations. Together we can maximize the opportunity to treat diseases currently treated by biologic agents with small molecules and thus benefit millions of people suffering from severe diseases," says Mr Ismail Kola, president, UCB New Medicines. UCB will be entitled to initial upfront, preclinical and clinical development milestone payments from Sanofi, potentially exceeding â‚¬100 million.A wide range of human diseases are driven by dysregulated immune function. There are hundreds of immune-mediated disorders that include joint diseases such as rheumatoid arthritis, inflammatory bowel diseases such as ulcerative colitis and Crohn's disease. Often these diseases are characterized by inappropriate activation of molecules termed cytokines, which are important mediators of normal immune function. ]]> <![CDATA[India - Emerging leaders in molecular imaging ]]> https://biospectrumindia.com/news/95/3687/india-emerging-leaders-in-molecular-imaging-.html https://biospectrumindia.com/news/95/3687/india-emerging-leaders-in-molecular-imaging-.html Tue, 11 Mar 2014 16:53:14 +0530 The conference brought together radiologists across India and US, to discuss and share knowledge on the advances in Onco & Interventional Radiology in diagnosing & staging, which is playing a vital role in the precise diagnosis of cancer. In conference the topic of discussions were breast cancer diagnosis, role of nuclear medicine in cancer diagnosis, advancement in brain tumor diagnosing through molecules, molecular imaging, bio marker development and post treatment imaging of cancer and so on. "With advancements in molecular imaging and nuclear medicine, there has been a revolutionary change in diagnosing cancer by non- invasive techniques. This has led to personalized treatment planning & patient care. India is emerging as one of the leaders in molecular imaging. This conference will immensely benefit the young radiologists and oncologists, in the diagnosis of cancer and delivering better medical outcomes" commented Dr KG Kallur, director, Imaging Services, HCG. Furthermore, Dr Chaitanya Divgi, chief of Nuclear Medicine & Molecular Imaging and professor & research vice-chairman, Radiology, Columbia University, New York, opined "The development of molecular imaging allows novel methods for evaluating disease and selecting the most beneficial therapies, particularly in cancer and also in other diseases. The emergence of India as a leader in health care delivery and development will occur even more rapidly with conferences and continuing medical education programs like this." In the conference benefits of molecular imaging was talked about. The benefits attributed were like gathering information that is inaccessible with other imaging technologies or that would require more invasive procedures such as biopsy or surgery, Helps in identification of the recurrence of the disease and many other benefits to add to this. ]]> <![CDATA[Medical electronics market to be worth US $11.7 billion by 2017 : Report]]> https://biospectrumindia.com/news/95/3690/medical-electronics-market-to-be-worth-us-11-7-billion-by-2017-report.html https://biospectrumindia.com/news/95/3690/medical-electronics-market-to-be-worth-us-11-7-billion-by-2017-report.html Tue, 11 Mar 2014 11:32:00 +0530 India's burgeoning population, higher middle-class incomes, and increasing awareness about the benefits of healthcare delivery system has catalyzed growth of the medical electronics market. In addition, rise in lifestyle diseases, increasing urbanization, healthcare facilities' expansions, has increased the demand for medical care, boosting medical electronics industry volumes. Government schemes to provide basic healthcare facilities in rural and remote areas have also played a key role in driving adoption of medical equipment that are ultimately boosting the medical electronic industry. Total healthcare expenditure in India is nearly 4 percent of the GDP, which is less than half of countries like Australia, Brazil, the UK, and US. Government expenditure on healthcare remains around 1.2 percent of GDP. This is again less than one-third of spend as a percentage of GDP in countries like the US, UK, and Australia. With a population of nearly 1.25 billion, an increased spending on healthcare is not an option but an imperative for India. The Government plans to increase public spending on healthcare to 2.5 percent of GDP in its 12th Five Year Plan. According to Frost & Sullivan, the medical electronics market in India was valued at US $6.5 Bn in 2013 and is likely to grow at a compound annual growth rate of 16 percent to reach US $11.7 Bn by 2017. However, indigenous manufacturing in medical electronics is still lacking in India. The Government has aided in the form of tax and duty exemptions to boost local manufacturing of medical electronics. The National Policy on Electronics has medical electronics as one of the thrust areas and provides for financial incentives for medical electronics manufacturing not only for new units but also for units relocating from outside India. The Drugs and Cosmetics (Amendment) Bill, 2013 is now considering recognizing medical devices as separate from pharmaceutical products in the regulatory structure. A strong framework that provides for medical devices standards in India is an imperative to boost domestic manufacturing, bring in reliability, and better time to market new technologies in medical electronics. According to Niju V, Director, Automation & Electronics Practices, Frost & Sullivan, "In India, medical devices need to be made for Indian operating conditions. Focused policy on medical devices factoring in all industry stakeholders including technology developers, manufacturers, healthcare providers, insurance providers, and patient groups can give a big boost to the sector." According to Frost and Sullivan, for providing healthcare, which is universal, affordable, and preventive in nature, the Indian medical electronics industry will shift towards developing miniaturized, multifunctional, ultra-low power, portable, and reduced cost devices that could be used for patient monitoring, imaging, implantable, therapeutic, and surgical requirements. The wearable devices category, which is still a developing field in India, can potentially aid physicians to offer extended care outside the clinical environment. This will bring higher efficiency and increased access across Tier 2, Tier 3 cities, and rural India, while providing improved healthcare delivery to urban India. According to Niju V, "Five aspects including miniaturization through System on Chip (SoC) designs, wireless integrated circuits, efficient power management, intelligent sensors, and connected IT infrastructure will dominate future technology landscape of the Indian medical electronics industry." ]]> <![CDATA[Hospital-to-Home: A new healthcare solution]]> https://biospectrumindia.com/interviews/95/4137/hospital-to-home-a-new-healthcare-solution.html https://biospectrumindia.com/interviews/95/4137/hospital-to-home-a-new-healthcare-solution.html Tue, 11 Mar 2014 11:27:35 +0530 Mr Arjen Radder, president, Philips Healthcare, APAC, talks about Royal Philips' initiatives to make healthcare accessible to everyone with ease, in the wake of growing healthcare challenges. Why has Singapore been chosen to establish the headquarters for the Royal Philips Hospital-to-Home (H2H) business? Mr Radder: In the Asia-Pacific region, Singapore presents the right conditions to establish the competence center for our highly innovative Hospital-to-Home program. Singapore serves as a reference site for its established healthcare system and as the healthcare hub for the region.Singapore care system is centered on the principle of shared ownership and joint responsibility between individual, family, community, and government for healthcare outcomes. Philips H2H shares that principle as well. We seek to improve patient's involvement and increase self-management of health. Singapore's forward looking healthcare system encourages co-innovation between healthcare providers and industry players like Philips; that is why we chose to establish our regional base there. What gave birth to this new innovation?Philips is dedicated to creating the future of healthcare by developing innovative solutions in partnership with clinicians and our customers to improve patient outcomes, to provide better value, and to expand access. Philips is uniquely positioned to facilitate optimal connections among care providers, enabling a shift from the traditional inpatient/outpatient mindset, to a single, quality-extended healthcare experience where recovery is shortened and the risk of re-hospitalization is lowered, especially for chronically ill patients. We have great expertise in healthcare data analytics, too, to enable predictive and timely interventions, delivering accurate answers at the time of need, and detecting critical issues before they become full-blown emergencies. Philips understands that people would much rather stay at home than be admitted to the hospital due to high costs. We develop innovative solutions across the continuum of care in partnership with clinicians and our customers to improve patient outcomes, provide better value, and expand access to care. Therefore, we are focusing our innovation lens on clinical programs around re-admission avoidance. We call these Hospital-to-Home solutions that are tailored to the local care ecosystem and literally bridge the hospital and the home for a truly patient-centered care model. How are you going to proceed further in terms of spreading it in Asia? Singapore is at the heart of Asia and is often looked at as the benchmark for care systems innova-tion. As a country, Singapore is constantly disrupting and innovating itself and as such, key learnings from here is often spread across to the other markets. With an integrated approach to healthcare by Philips, key takeaways will be shared through our Singapore competence center for the region. We aim to disseminate and co-create H2H solutions with healthcare professionals across the region. Also relevant for the broader region, we see a critical shortage of medical staff as a major issue in many markets in Asia. Philips H2H will help train and educate healthcare professionals to not only help them in their daily workflows but also offer consulting services to improve operational and financial performance of hospitals and health systems. The key benefit of having this capability in Singapore is that it will see regular updates and learning can be easily shared with professionals across the region; we directly and indirectly want to influence the rise in quality of healthcare by thinking of the home as a natural extension of care continuum. What are the challenges that you are likely to face while implementing this innovative and interesting concept? The future of healthcare worldwide is fueled by the fact that we are growing older, we are getting sicker, and the global demand and cost of care is increasing. Chronic illnesses are rising faster in this region than globally and the sheer number of people requiring care is staggering. This is disproportionately affecting developing markets like South East Asia and at Philips, we hope we can work in tandem with developed and developing markets to address the healthcare challenges and provide innovative solutions throughout the region. We have a common goal: we want people to be healthy, live well, and enjoy life as we tackle the undeniable challenge of quality affordable care. How has been the Singapore Economic Development Board's attitude towards this project?Singapore is known for its capability to reinvent itself - at the core of such innovations are leading government entities like the EDB, who for years have helped policy makers steer the country towards the most exciting and future-oriented economic sectors. It is not different with healthcare, where EDB and local government play a key role in organizing policy and creating the right conditions for innovation to flourish. How is the healthcare industry going to evolve in the coming years?The aging population and their increased burden on the healthcare system have driven a level of need not experienced by South-East Asia in the past. A rapidly aging population, coupled with an expanding middle class and the rise of NCDs - with limited resources in the healthcare sector across the region - has led to increased access and quality but at increasingly accelerating economic cost to the society. Basic insurance is not common, healthcare systems are developing continuously, and this has an impact on affordability for many. While countries can continue to add more hospital beds and attempt to train more doctors and nurses, it is not a sustainable approach to meet the level of healthcare that an aging population demands. The rise of chronic diseases is also straining healthcare resources, as they are the most common and costly of health problems. The solution to provide care for more patients with existing healthcare resources is straightforward - of, maximize the utilization and take benefit of the current medical resources by managing patients from home and reduce their length of stay and mortality rates.What are the future plans of Royal Philips and are there any collaborations in the pipeline? At the moment, the most urgent need of the healthcare sector in the region is to focus on providing the public with access to affordable healthcare services. As the region continues to age rapidly, especially among developed countries, and will see more need for home healthcare solutions. Monitoring and managing patients from their home will ease the burden on healthcare institutions. Philips also works continuously to help cater to the needs of healthcare institutions in developing markets, especially healthcare institutions in rural areas, and introduces innovative solutions to these markets. By bringing together expertise from across our businesses, our ambition is to deliver innovative solutions like Hospital-to-Home that connect and empower the entire care teams, patients, families, friends, and providers. Our goal is to improve the system for clinicians, patients, and caregivers. As such, Philips is introducing healthcare innovations that will help health systems in Asia to address the growing challenges linked to a fast growing and aging population. ]]> <![CDATA['Vaccine business: A game of snakes-and-ladders']]> https://biospectrumindia.com/news/95/5732/vaccine-business-a-game-of-snakes-and-ladders.html https://biospectrumindia.com/news/95/5732/vaccine-business-a-game-of-snakes-and-ladders.html Mon, 10 Mar 2014 16:09:00 +0530 The annual revenue of the global vaccine industry is expected to be USD 35 billion for 2014. With Compounded Annual Growth Rate (CAGR) 11.5%, industry experts believe that the global vaccine is expected to be valued at USD 52 billion by 2016. Though the vaccine industry looks promising, there seems to be inevitable challenges and road-blocks faced by many companies, including: access to new technologies; regulatory challenges; vaccine clinical trials; obtaining patents and IP; limitations to development; production scaling; and manufacturing productivity. Dr Krishna Ella, founder, Bharat Biotech, India, in his opening remarks said, "Everyone today is talking about innovation and costs. Over 15% of the world's population is accumulated in the developed world, and about 80% in the developing world. We spend less than 1% of our GDP on healthcare. Though the healthcare budget has come close to $5.5 billion, we spend only $100 million on vaccines." The keynote was delivered by Dr Ted Bianco, director of technology transfer, Wellcome Trust, United Kingdom, who presented on the topic, 'Facilitating Innovation in Vaccine Development through the Interplay of the Public and Private Sectors.' He said, "So far, Wellcome Trust has supported 270 projects." He emphasized that there is a clear great need for partnerships in the vaccine R&D. "It is detrimental to have unrealistic business cases and win-lose partnership arguments," opined Dr Bianco. "The vaccine business is less a game of monopoly, and more a game of snakes-and-ladders', and nobody wants that," further added Dr Bianco. Dr Ella concluded, "So it is not the lack of money... Something seems to be wrong somewhere.. We have been manufacturing vaccines since 1999, and it costs less than the price of a water bottle on your tables. But things are changing now... Public-private and private-private partnerships are helping us to tackle neglected diseases. Big companies should work with emerging world which can reach the neglected markets." The conference witnessed exhibition stalls erected by PALL Life Sciences, Aptar Stelmi, ATMI Life Sciences, BIA Separations, West Pharma, HiMedia, and Healthgen Biotechnology. Raj Gunashekar in Hyderabad ]]> <![CDATA[Indian medical electronics market estimated to grow $11.7 bn by 2017 ]]> https://biospectrumindia.com/news/95/5805/indian-medical-electronics-market-estimated-to-grow-11-7-bn-by-2017-.html https://biospectrumindia.com/news/95/5805/indian-medical-electronics-market-estimated-to-grow-11-7-bn-by-2017-.html Mon, 10 Mar 2014 14:46:10 +0530 India's burgeoning population, higher middle-class incomes, and increasing awareness about the benefits of healthcare delivery system has catalyzed growth of the medical electronics market. In addition, rise in lifestyle diseases, increasing urbanization, healthcare facilities' expansions, has increased the demand for medical care, boosting medical electronics industry volumes. Government schemes to provide basic healthcare facilities in rural and remote areas have also played a key role in driving adoption of medical equipment that are ultimately boosting the medical electronic industry. Total healthcare expenditure in India is nearly 4 percent of the GDP, which is less than half of countries like Australia, Brazil, the UK and US Government expenditure on healthcare remains around 1.2 percent of GDP. This is again less than one-third of spend as a percentage of GDP in countries like the US, UK, and Australia. With a population of nearly 1.25 billion, an increased spending on healthcare is not an option but an imperative for India. The Government plans to increase public spending on healthcare to 2.5 percent of GDP in its 12th Five Year Plan. According to Frost & Sullivan, the medical electronics market in India was valued at $6.5 bn in 2013 and is likely to grow at a compound annual growth rate of 16 percent. However, indigenous manufacturing in medical electronics is still lacking in India. The government has aided in the form of tax and duty exemptions to boost local manufacturing of medical electronics. The National Policy on electronics has medical electronics as one of the thrust areas and provides for financial incentives for medical electronics manufacturing not only for new units but also for units relocating from outside India. The Drugs and Cosmetics (Amendment) Bill, 2013 is now considering recognizing medical devices as separate from pharmaceutical products in the regulatory structure. A strong framework that provides for medical devices standards in India is an imperative to boost domestic manufacturing, bring in reliability, and better time to market new technologies in medical electronics. Mr Niju V, director, Automation & Electronics Practices, Frost & Sullivan, "In India, medical devices need to be made for Indian operating conditions. Focused policy on medical devices factoring in all industry stakeholders including technology developers, manufacturers, healthcare providers, insurance providers, and patient groups can give a big boost to the sector." Conferring to Frost and Sullivan, for providing healthcare, which is universal, affordable, and preventive in nature, the Indian medical electronics industry will shift towards developing miniaturized, multifunctional, ultra-low power, portable, and reduced cost devices that could be used for patient monitoring, imaging, implantable, therapeutic, and surgical requirements. The wearable devices category, which is still a developing field in India, can potentially aid physicians to offer extended care outside the clinical environment. This will bring higher efficiency and increased access across tier 2, tier 3 cities, and rural India, while providing improved healthcare delivery to urban India. ]]> <![CDATA[India's â€œhotâ€? biotech start-ups]]> https://biospectrumindia.com/views/95/5487/indias-hot-biotech-start-ups.html https://biospectrumindia.com/views/95/5487/indias-hot-biotech-start-ups.html Mon, 10 Mar 2014 12:37:00 +0530 This is the 11th anniversary editorial of BioSpectrum, which I am writing in a row since 2003. BioSpectrum was born in the stable of IQ Tech Media in 2002. It changed hands to become part of CyberMedia in late 2002 and stayed there for more than 10 years until September 2013. And now it is part of MM Activ Sci-tech Communications. The publisher may have changed. But what has not changed with BioSpectrum is its chosen role: to be the catalyst for the growth of India's biotechnology industry. This editorial will be in four parts to highlight four major trends or events that are nudging the biotech industry in a way that may alter its contours in the comings years. **************11 "hot" biotech start-upsDr Krishna Ella, a scientist turned first-generation entrepreneur, received the first BioSpectrum Entrepreneur of the Year Award in 2003 when his company Bharat Biotech International, Hyderabad, had revenues of only Rs15 crore. In 2013, when Dr Ella was chosen the BioSpectrum Person of the Year, Bharat had revenues in excess of Rs300 crore. Bharat Biotech is one of the handful of companies picked up by software Moghul and philanthropist Mr Bill Gates for special mention in 2013 for its role in pushing affordable healthcare to all corners of the world. So can we identify the current decade's Bharat Biotechs in the making? That is what the BioSpectrum team set out to do for the 11th Anniversary Special issue. There has been frenetic entrepreneurial activity in the biotech sector in the last five years. What we have presented in this issue is a list of 11 companies that came up in the last five years, which we consider to be the winners in the next decade. The 11th listing is a collection of companies that are operating in the genomics area that have been bunched together. For each of them have something unique to offer that will make waves in the coming years. The first wave of biotech entrepreneurship started in the late 1990s and the second one in the 2004-06 period. Many of these companies have reached reasonable size. Some have fallen by the wayside. Some can pick up the pieces if they are offered some support systems. Can someone help the current set of entrepreneurs with tips and help them avoid the pitfalls of their predecessors? This has been one question bothering me and many others in the biotech ecosystem for some time. However, I need not worry about this anymore. Dr Anand Anandkumar of Cellworks, Bangalore, and few like-minded entrepreneurs have come up with a brilliant solution. They have set up a company that will help start-ups. Escape Velocity Accelerator (EVA) is the name of the Bangalore-based company that is going to handhold new entrepreneurs and let them defy the gravity of growth. "EVA is an accelerator helping start-ups in the life sciences and healthcare domains turn their venture into sustainable high value companies that operate in the exciting intersection space of information technology and biotechnology," declares the mission statement. A dozen mentors have already signed up to accelerate Indian biotech. You are surely going to hear about them in the next few months. The future of Indian biotechnology is in safe hands. *********** ]]> <![CDATA[DCGI: Allegations of fake Indian drugs baseless]]> https://biospectrumindia.com/news/95/3685/dcgi-allegations-of-fake-indian-drugs-baseless.html https://biospectrumindia.com/news/95/3685/dcgi-allegations-of-fake-indian-drugs-baseless.html Mon, 10 Mar 2014 12:02:24 +0530 The public information cell of the Drugs Controller General of India has issued a statement contradicting a New York Times report that claimed that 'India-made drugs trigger safety concerns in the US'. DCGI's statement said that the report made some "baseless, irresponsible and malicious" claims by stating that WHO estimates that one in five drugs made in India is a fake. The report further added that WHO had clarified as recently as on August 31, 2012 that there was no such study carried out by the WHO. "They have also regretted that occasionally some individuals in the media and the organizations use WHO references incorrectly and even irresponsibly," the release said. The report added that a section of the print media - Indian as well as foreign - has been publishing "factually incorrect and largely unsubstantiated" news "to malign the well-earned reputation of the Indian pharmaceutical industry". India exports around $15 billion of pharma products, including vaccines to most of the countries in the world. There are about 360 USFDA-approved drug manufacturing units in the country. There are also over 150 European Directorate for the Quality of Medicines (EDQM)-approved drug manufacturing units. As recently as 2013, the WHO has declared the Indian national regulatory authority functional for vaccines against stringent international parameters. The release said harmonization of regulatory standards has not yet been achieved even among the three major regions - North America, Europe and Japan. A product from India complying with the US standards would still have to comply with the regulatory requirements of Japan if it has to be exported to Japan. India has its own law governing the regulatory norms and standards. Manufacturers have to conform to these norms and standards. However, any Indian pharmaceutical product entering the US market complies with the US standards. It added that Indian laws and India's robust regulatory framework ensure high standards of quality, safety and efficacy of drugs manufactured in the country. ]]> <![CDATA[Two Glenmark Pharma arms receive nod to merge]]> https://biospectrumindia.com/news/95/6063/two-glenmark-pharma-arms-receive-nod-to-merge.html https://biospectrumindia.com/news/95/6063/two-glenmark-pharma-arms-receive-nod-to-merge.html Mon, 10 Mar 2014 11:47:42 +0530 Indian pharma major, Glenmark Pharmaceuticals has received an approval from the fair trade watchdog, Competition Commission of India (CCI) for the merger of two subsidiaries with itself. The CCI has given its nod for the merger of Glenmark Access and Glenmark Generics with Glenmark Pharmaceuticals. "There would be no change in the ultimate control as a result of the proposed combination," the CCI said in a statement. Glenmark Pharmaceuticals, that is involved in the manufacturing, sale and distribution of branded generic products currently holds 100 percent stake in Glenmark Access and 98.14 percent shareholding in Glenmark Generics. Glenmark Access, which holds 1.19 percent in Glenmark Generics is engaged in exporting pharmaceutical products while the latter is into the business of pharmaceutical formulations and active pharmaceutical ingredients (APIs). ]]> <![CDATA[Suven grants exclusive license to Taro Pharmaceuticals ]]> https://biospectrumindia.com/news/95/3618/suven-grants-exclusive-license-to-taro-pharmaceuticals-.html https://biospectrumindia.com/news/95/3618/suven-grants-exclusive-license-to-taro-pharmaceuticals-.html Fri, 07 Mar 2014 17:28:33 +0530 Malathion lotion is indicated for patients infected with Pediculus humanus capitis (head lice and their ova) of the scalp hair. In this regard, Taro will pay Suven a royalty and the arrangement is effective until April 2028, unless otherwise terminated. ]]> <![CDATA[Singer Shaan supports genetic disorders patients ]]> https://biospectrumindia.com/news/95/3562/singer-shaan-supports-genetic-disorders-patients-.html https://biospectrumindia.com/news/95/3562/singer-shaan-supports-genetic-disorders-patients-.html Fri, 07 Mar 2014 16:47:13 +0530 Over 50 Children from across state suffering from rare diseases gathered in city today to participate in a rare disease awareness program. The event was organized by the Lysosomal Storage Disorder Support Society (LSDSS). The aim was to create more awareness the public about among rare diseases and seek financial support from the government for the treatment of these debilitating genetic disorders. The program witnessed a gathering of doctors and young children suffering from extremely rare type of genetic disorders such as Gaucher, MPS, Fabry and Pompe. The treatment of these very serious health conditions has become available with advancements in medical science, but is beyond the paying capacity of most patients. The hope for a better tomorrow triggered tremendous enthusiasm among the children at the event, as singer Shaan came forward to support and motivate the patients suffering from LSDs. Patients suffering from Lysosomal storage Disorders (LSDs) are very few in number in India because of the rarity of these diseases. Dr Priya Kishnani, professor of Pediatrics, Division of Medical Genetics, Duke University said, " Patients suffering from Lysosomal storage Disorders (LSDs) are few in number (1 in 5000-7700) therefore their families have to face many hurdles in locating appropriate healthcare facilities and support centers that can provide them proper treatment and care. The treatment of some of these serious conditions has now become available with advancements in medical science but is beyond the paying capacity of most patients." Lysosomal storage disorders (LSD) are a group of over 45 rare genetic disorders that occur due to the deficiency of specific enzymes in special compartments (lysosomes) of cells. LSDs occur in about one in 5,000 live births. A majority of LSDs are managed through supportive care measures that are disease-specific. However, six of the LSDs can now be treated through Enzyme Replacement Therapies (ERTs). India currently has about 300-400 patients who have been diagnosed with treatable LSDs. Appealing to the state government of Maharashtra, Manjit Singh, president, Lysosomal Storage Disorders Support Society, said, "As treatment of these diseases is very expensive, it is beyond the reach of most of the LSD patients. Only government support can save these people and help them lead a better and close to normal life. The need of the hour is a government scheme to provide free treatment for patients with rare disorders. They are very few in number and it is the duty of the state to provide treatment for them." ]]> <![CDATA[Unique PPP to provide e-healthcare in Odisha]]> https://biospectrumindia.com/news/95/3560/unique-ppp-to-provide-e-healthcare-in-odisha.html https://biospectrumindia.com/news/95/3560/unique-ppp-to-provide-e-healthcare-in-odisha.html Fri, 07 Mar 2014 16:34:38 +0530 Canara Bank has lent support to Biocon Foundation and OTTET (Orissa Trust of Technical Education) for a unique public private partnership (PPP) with the Odisha government to deliver a novel e- healthcare program for the underprivileged and rural communities in the state. OTTET has been actively engaged in an e-Health program with the Government of Odisha through PPP to provide access to quality healthcare for 51,000 villages in Odisha. Biocon Foundation has joined hands with OTTET to augment and implement a unique mega-ICT based e-Health project in the state. The partners through this collaboration will strive to deliver evidence-based health care to effectively deal with primary health and chronic conditions in communities that have poor access to quality healthcare. Commenting on this unique PPP model, Kiran Mazumdar-Shaw, CMD, Biocon said, "We are very pleased to receive support from Canara Bank for enabling our partnership with OTTET to realize the objectives of delivering e-healthcare to the people of Odisha. This unique social entrepreneurship model will result in the creation of real jobs and development of semi-skilled talent in the rural areas. This demonstrates our commitment towards inclusive development by empowering rural communities." This young entrepreneur will be provided financial assistance by Canara Bank and will be trained by Biocon Foundation & OTTET to support the medical officer at the PHC for various healthcare and diagnostic services.An MOU was signed today between Biocon Foundation, Canara Bank and OTTET. OTTET managing trustee, Mr KN Bhagat said "We are committed to creating parity for all through the unity of technology and social entrepreneurship that will deliver Healthcare for all & Services for all. We believe this PPP model will achieve all-round Socio-Economic & National Development."He further added "The project aims to provide rapid diagnosis, reduce out of pocket expenses and drastically, cut down hospitalization whilst ensuring transparency and accountability for every single patient". Furthermore, this model will focus on getting all the patient records captured on the electronic system which will provide easy access for the treating doctors both at the PHC and at tertiary hospitals. It will ensure that each patient's life long medical record is available online thus improving the treatment standards across all health centers. In addition, patient data will be available to the government to study disease patterns and to create a database, which will help implement evidence based health care interventions. ]]> <![CDATA[Select Bt Cotton hybrids approvals to happen soon]]> https://biospectrumindia.com/news/95/4675/select-bt-cotton-hybrids-approvals-to-happen-soon.html https://biospectrumindia.com/news/95/4675/select-bt-cotton-hybrids-approvals-to-happen-soon.html Fri, 07 Mar 2014 15:49:00 +0530 The department of biotechnology (DBT) has invited applications for consideration by the standing committee for commercialization of Bt cotton hybrids under Event Based Approval Mechanism (EBAM). The applications for commercial release of Bt cotton hybrids expressing approved events under EBAM may be submitted to member secretary (EBAM), RCGM Secretariat for consideration in the next meeting of the standing committee scheduled to be held on March 20,2014. The applications for a maximum of two Bt cotton hybrids per applicant per zone or state may be submitted for North, Central and South Zones by March 14, 2013 with the following information on confirmation of gene/ event through molecular characterization by the licencor stating that the gene/s being used is one of the approved events (LOC in original. Also the other information that has to be provided includes the level of protein expression in green house and field trials; orphological characters using DUS descriptors as per PPVF&RA guidelines for the hybrids as well as parental lines; bio-efficacy data generated in laboratory conditions; authorization certificate/ No Objection Certificate (NOC) in original from technology provider in case of sub-licensee; affidavits duly signed by the Notary on Stamp Paper. Also each application shall contain data pertaining to single hybrid only as inclusion of a lot of hybrids in a single application causes hardship in evaluation of the data. Individual application should be submitted for each State/Zone. Applications submitted earlier/pending cases of earlier Standing Committee meetings will not be considered. Field trial data of the particular hybrid at least from one SAU per state of the particular Zone. In addition to yield parameters, the data should include the quality aspects as well as reaction of test hybrid against insects and diseases as recorded under AICCIP; Seed cotton yield should be superior to the best check. For Central and South Zones, the SAU data may be provided keeping in view of the rainfed/irrigated regions and may be submitted for both regions to ensure approval for the entire State. Number and names of hybrids approved under EBAM so far for each State, names of hybrids available in the market, and how the proposed hybrids are better than the approved hybrids. Data on tolerance of Bt cotton hybrids to CLCuV in North Zone (only for hybrids to be released in North Zone) as evaluated by SAU Centre in North Zone/CICR, Sirsa. Current status of Bt cotton hybrids approved by Standing Committee under EBAM for commercialization: The notification from DBT makes it clear that punitive action will be initiated in case of providing any wrong information/declaration on any of the above items (1-12). ]]> <![CDATA[Serum Institute, Beethovan Biologicals partner to reduce polio vaccine prices]]> https://biospectrumindia.com/news/95/7866/serum-institute-beethovan-biologicals-partner-to-reduce-polio-vaccine-prices.html https://biospectrumindia.com/news/95/7866/serum-institute-beethovan-biologicals-partner-to-reduce-polio-vaccine-prices.html Fri, 07 Mar 2014 13:28:49 +0530 Serum Institute and Bilthoven Biologicals have endeavoured to support the programme to reach the Global Polio Eradication Initiative [GPEI] Endgame Strategic Plan 2013-2018, by substantially reducing the price of IPV from the prevailing price available in the market, in the recent tender bid with UNICEF. This is for the first time that the two Companies have joined hands together to make IPV available to UNICEF at a subsidized rate, which resulted in triggering a global reduction in price of IPV. Dr Roeland van Dam, CEO of Bilthoven Biologicals announced the reduction in IPV price for the first time compared to the prevailing price of IPV, solely due to the financial subsidization of the cost provided by Serum Institute of India. This has been achieved with the objective of providing vaccines to the poorer countries of the world. Dr Cyrus S. Poonawalla, Chairman of Serum Institute of India, stated that he was proud to support the IPV programme to reach the GPEI Endgame Strategic Plan 2013-2018, in keeping with his commitment to the World Health Organization to make available Polio vaccine as affordable as possible. With the R&D efforts that are put in, he is confident that the price of IPV will further reduce in the future. Both Bilthoven Biologicals and Serum Institute of India continue their efforts to develop their production both in numbers and reduction in price for the future, which benefit they expect to pass on [as they have done several times in the past] to the poorer countries requiring vaccine for moving towards the GPEI Endgame Stragetic Plan 2013-2018. Recently Serum Institute of India has stepped-in to resolve the acute shortage of hundreds of million doses of OPV, required by the U.N. Agencies, at short notice and at affordable prices, thus mitigating a Polio vaccine availability crisis. It would be relevant to note that Bilthoven Biologicals has not only offered a special price for the poorer countries compared to their past price, but extended this uniformly to all other 120 countries which were equally in need of this vaccine to be introduced for achieving the GPEI Endgame Stragetic Plan 2013-2018. ]]> <![CDATA[Ensocare, GE Wipro erects country's largest healthcare project ]]> https://biospectrumindia.com/news/95/8121/ensocare-ge-wipro-erects-countrys-largest-healthcare-project-.html https://biospectrumindia.com/news/95/8121/ensocare-ge-wipro-erects-countrys-largest-healthcare-project-.html Thu, 06 Mar 2014 16:54:00 +0530 In a PPP initiative Dr Satish Pawar, director health services, Mr Akhil Khan,vice chairman Ensocare, Dr Shakil Khan, managing director Ensocare and Mr Milan Rao, COO Wipro GE healthcare inaugurated the first largest healthcare in India, at Pune. With the investment ranging around total of Rs 18 crores, Aundh district Hospital, and a government hospital will be providing state-of the art diagnostic facilities to all the citizens with Ensocare's efforts. Dr Pawar, director health service commented "I congratulate the colossal efforts of the Maharashtra Government, Ensocare and Wipro GE which have resulted in this one-of-its kind Diagnostic center." The hospital will be equipped with 1 unit of 64 slice CT scan, 2 units of 3d color doppler and radiography units amongst others which have been got hold from Wipro GE. These advanced equipments will lend a hand in early diagnosis and treatment of all orthopaedic, gynecological and obstetric disorders, upper and lower respiratory disorders, all neurological, abdominal and nephrotic disorders. With the increase in the cases of breast cancer, womens health will be given a special boost with the inclusion of 1 screening mammography unit. Dr Akil Khan, vice-chairman, Ensocare expressed "More than 305 patients who visit Government hospitals in Pune are unhappy with the treatment they receive. Hence the opportunity as provided by this PPP will help us change the dynamics of healthcare in the city as well as country." The diagnostic center will run on 24/7 basis under the vigilance of experts from Ensocare. The services will be provided at government recommended rate cards for the benefit of all patients enrolled under the Rajiv Gandhi Jeevandayi Aarogya Yojana plus all 19 categories under government resolution for free medical services. The center holds the capacity of treating about 450-700 patients per day. The newly set up Diagnostic center is established to meet the growing need of superlative diagnostic care at affordable prices to the needy. Furthermore, Dr Shakil Khan, managing director, Ensocare added "We are excited to announce the start of operations of our first center and thank the support and the presence of the Government to help us create meaningful impact on the wellbeing of overall Indian society. Currently our focus lies in providing value added services and free treatments for the extreme bottom of the pyramid patients with the help of IT innovation, cutting edge technology and well-trained medical staff of the city. Moving forward we are investing time in building our management bandwidth and operational capabilities to execute better radiology and diagnostic facilities at 21 other centers across the state." ]]> <![CDATA[DrÃ¤ger launches Evita V300 at CRITICARE 2014 ]]> https://biospectrumindia.com/news/95/5018/drger-launches-evita-v300-at-criticare-2014-.html https://biospectrumindia.com/news/95/5018/drger-launches-evita-v300-at-criticare-2014-.html Thu, 06 Mar 2014 16:44:13 +0530 DrÃ¤ger, an international leader in Medical and Safety technology today announced the successful launch of Evita V300, a new intensive care ventilator for adults, children and premature babies at CRITICARE 2014 organized by ISCCM in Jaipur. An innovator in the healthcare segment, DrÃ¤ger reiterates its focus on Ventilation and Respiratory Monitoring through Evita V300 which offers sophisticated ventilation possibilities and many other options. With the Evita V300, physicians can select the functions required for their therapy from almost all of the DrÃ¤ger ventilations modes and applications. Further emphasizing the theme of the event, DrÃ¤ger's booth showcased their range of high quality and advanced medical devices and systems in the Intensive Care Division. This integrated approach towards Critical Care helped DrÃ¤ger fortify its motto of 'Technology for Life' amidst its target audience. Speaking on the occasion, Mr Nikhil Rao, country manager, DrÃ¤ger India said, "We are extremely delighted to announce the launch of Evita V300. With deep industry expertise and focus technology innovation products like Evita V300 that provides ventilation for adults, children and neonates, DrÃ¤ger plans to revolutionize the Ventilation and Respiratory industry in 2014." During the event, Dr RK Mani, director, Pulmonology, Critical Care and Sleep Medicine, Saket City Hospital, conducted a session on EIT (Electrical Impedance Tomography) where he elaborated on PulmoVista 500, the first EIT device intended for everyday clinical use by intensivists to view regional distribution of lung ventilation directly at the bedside. Dr RK Mani said "Electrical Impedance Tomography is an innovative way of bedside real time noninvasive lung imaging that holds great promise in aiding safe mechanical ventilation in ARDS patients. For decades there has been an ongoing search for a bedside tool that can reliably visualize regional differences in ventilation in lungs affected by ARDS. These new bedside data have the potential to greatly assist in setting effective and lung protective mechanical ventilator parameters in a condition in which the lung is highly vulnerable to iatrogenic injury." ]]> <![CDATA[Health ministry junks media reports on DCGI, says country being maligned]]> https://biospectrumindia.com/news/95/7861/health-ministry-junks-media-reports-on-dcgi-says-country-being-maligned.html https://biospectrumindia.com/news/95/7861/health-ministry-junks-media-reports-on-dcgi-says-country-being-maligned.html Thu, 06 Mar 2014 15:24:00 +0530 As per the health ministry, the intention appears to be to malign the well-earned reputation of the Indian national regulatory authority i.e. the office of the Drugs Controller General (India) as well as the quality of drugs manufactured by the Indian pharmaceutical industry. Refering to On 30 January 2014, Business Standard interview of Dr. G N Singh, DCG (I) published on January 30, 2014, with the caption "If I follow US standards, I will have to shut almost all drug facilities", the health ministry termed it as an attempt to sensationalize rhe issue. The context, content and the manner in which the report has been printed appear to have completely distorted the factual statements made by the DCG (I) to make the news item highly sensational. There are adequate provisions under the Drugs and Cosmetics Act 1940 and Rules made there under for ensuring the quality, safety and efficacy of drugs manufactured in India for marketing. In fact Indian drug products are accepted in more than 205 countries which include both developed and developing countries. The health ministry goes on to refer to a report by on The Times of India, Delhi edition on February 16, 2014 that carried an article reprinted from the New York Times, authored by Gardiner Harris, with the caption "India-made drugs trigger safety concerns in US". The article quotes the statement attributed to Dr GN Singh which had appeared in Business Standard. Harris has, however, gone further to make some baseless, irresponsible and malicious claims by stating that "WHO estimates that 1 in 5 drugs made in India is a fake". However, the fact is that the WHO had clarified as recently as on August 31 2012 that there was no such study carried out by the WHO. WHO has also "regretted that occasionally some individuals in the media and the organizations use WHO references incorrectly and even irresponsibly." It again mentions a news item that appeared in The Economic Times of February 26, 2014 under the caption "India's Drug Regulator Seen as Corrupt: Bate". The ministry's statement points out that in the article one Roger Bate of Washington DC think tank, the American Enterprise Institute has been quoted to have stated that "Indian companies are perfectly capable of manufacturing high quality drugs. However, there is a feeling among patients and physicians in the US that the Indian regulator is not monitoring properly. Indian drug regulator is seen as corrupt and colliding with pharma companies. That is damaging India's business in the US." Bate also cited last year's Parliamentary Standing Committee report which had found deficiencies in the drug regulatory system. The damaging accusations and allegations made by Bate are a direct assault on the integrity of the Drug Regulatory Office of India. The report seems to have been made with an intention to malign the image and damage the reputation of the highest drug regulatory body in the country. The newspaper, on its part, has not taken due care of seeking the version of the government or the regulator before printing such sensational comments by Bate. The statements made by Bate are largely based on his perceptions. As regards the Parliamentary Standing Committee report, it is mentioned that it is a regular feature in any democracy for Legislative Committees to scrutinise the functioning of all Government departments and make recommendations to bring about improvement in their functioning. It is no different in India. "The fact of the matter is that the office of Drugs Controller General (India) was inspected by an international team of WHO in 2013 and WHO has declared the Indian national regulatory authority functional for vaccines against stringent international parameters. The Indian pharmaceutical industry has also created an enviable niche in the World market for itself. India exports around US$15 billion of pharma products including vaccines to most of the countries in the world. There are about 360 US FDA approved drug manufacturing units in the country. There are also over 150 EDQM approved drug manufacturing units," health ministry release said. Terming the regulatory issues as global and not only India specific, health ministry goes on to say, "It is absolutely imperative to mention that harmonization of regulatory standards has not yet been achieved even among the three major regions, viz. North America, Europe and Japan. A product from India complying with the US standards would still have to comply with the regulatory requirements of Japan if it has to be exported to Japan. India has its own law governing the regulatory norms and standards. Manufacturers have to conform to these norms and standards. However, any Indian pharmaceutical product entering the US market complies with the US standards." The ministry further reiterated that the Indian laws and India's robust regulatory framework ensures the high standards of quality, safety and efficacy of drugs manufactured in the country. The allegations made in these news items are appears to be baseless and solely printed with the intension of harming the reputation of the Indian national regulatory authority as well as Indian drug industry. ]]> <![CDATA[President lists ICT, PPP as key drivers for healthcare ]]> https://biospectrumindia.com/news/95/3655/president-lists-ict-ppp-as-key-drivers-for-healthcare-.html https://biospectrumindia.com/news/95/3655/president-lists-ict-ppp-as-key-drivers-for-healthcare-.html Wed, 05 Mar 2014 16:23:00 +0530 The recent deliberations at the two day conference of the 'Healthcare Alliance', a multi-stakeholder collaborative project spearheaded by the Apollo Hospitals and Public Health Foundation of India (PHFI) concluded at New Delhi on March 4, 2014. It was followed by the presentation of the recommendations to the president of India, Mr Pranab Mukherjee at the Rashtrapati Bhavan. Speaking on the occasion, the president said that the need of the hour is for a much greater convergence of all stakeholders towards the common goal of an improved healthcare delivery system. It is also important not to lose focus on the fact that a powerful driver of health is education. Innovative models of partnership between the public and private sectors can improve the situation in India and also provide insights for the developing world. ICT can be a strong enabler in strengthening the reach of medical information and care. He stated that our healthcare systems must gear up to fully utilize this potential. As our battle against polio has shown, collective efforts can really make miracles happen. "Innovative models of partnership between the public and private sectors can improve the situation in India and also provide insights for the developing world. A sustained focus on healthcare excellence in India is crucial not only for our nation, but the world at large. India is a regional resource for high quality care. As one of the largest manufacturer and exporters of medicine, India has brought cost efficiency to the world in the generics domain. This is a huge advantage that needs to be leveraged further," said Mr Mukherjee The president said that leading healthcare providers around the world are exploring the incredible promise of our traditional healing. This is an avenue that should be further dwelt upon and we may possibly discover new cures for the new-age medical problems. The President urged all present on the occasion to make it their mission to infuse in all a passion for healthy living. Among the dignitaries present on the occasion were Mr Ghulam Nabi Azad, union minister of health and family welfare and Dr Prathap C. Reddy, chairman of Apollo Hospitals Group. ]]> <![CDATA[Asia's synonym to Biocluster: Singapore]]> https://biospectrumindia.com/interviews/95/7686/asias-synonym-to-biocluster-singapore.html https://biospectrumindia.com/interviews/95/7686/asias-synonym-to-biocluster-singapore.html Wed, 05 Mar 2014 15:00:00 +0530 1. How has the pharmabio industry in Singapore grown over the years? Koh Jin Hoe: At present, more than 30 of the world's leading biomedical sciences companies such as Pfizer, Merck Sharpe & Dohme, GlaxoSmithKline, Novartis and Takeda maintain a significant presence in Singapore, which speaks strongly of the sector's growth. The biomedical sciences (BMS) industry has rapidly grown to become the fourth pillar of Singapore's economy. Since 2000, BMS manufacturing output has increased by nearly five-fold from $6 billion in 2000 to $29.4 billion in 2012. In less than five years, Singapore has become home to nine biologics manufacturing facilities, including two latest investments by Novartis and Amgen, amounting to USD$500mil and USD$200mil respectively. Singapore has committed S$16.1 billion in continued support of research, innovation and enterprise activities between 2011 and 2015. Out of the S$16.1 billion, S$3.7 billion (23%) is allotted to enhancing the existing biomedical R&D infrastructure. 2. What kind of progress has been achieved in the field of clinical research in Singapore? Singapore has made significant progress in translational and clinical research. We currently have three Investigational Medicine Units dedicated for early-phase trials in public hospitals. The Singapore Clinical Research Institute, for example, focuses on supporting later-stage trials and bears the responsibility to develop Clinical Research Networks (CRN) in Asia-Pacific to support multi-site, multi-national clinical trials. These facilities will in turn support the growing community of clinician scientists in Singapore. We have seen an increase in the number of innovative early phase trials including first-in-man studies done in Singapore - positioning us as an R&D leader in Asia. Singapore has also established Clinical Trials Networks across the Asia-Pacific, including the Asia-Pacific Hepatocellular Carcinoma (AHCC) Trials Group, Family Medicine Research Network (FMRN), Pan-Asian Resuscitation Outcomes Study (PAROS) and so on. 3. What kinds of collaborations exist between Singapore research institutes and hospitals? Over the past 20 years, Singapore has steadily built a strong foundation of basic and clinical research through its biomedical research institutes under the Agency for Science, Technology and Research (A*STAR) and its universities including the National University of Singapore and Nanyang Technological University. Examples of collaboration between research institutes and universities and hospitals include: Five Translational & Clinical Research (TCR) Flagship grants awarded worth S$25 million each in the areas of gastric cancer, metabolic diseases, schizophrenia, dengue and eye diseases. These programs, which encourage co-application between clinicians and researchers, were designed to bring together the best complementary research strengths in hospitals and national disease centers, universities and A*STAR research institutes to focus on a disease or research themes of strategic importance to Singapore. 4. Has the government of Singapore launched any special initiatives to support the pharma and healthcare industry? The government provides awards to clinician-scientists such as the Singapore Translational Research (STaR) Investigator Award, Clinician Scientist Award (CSA), which provides research funding and salary support to enable medical researchers to devote more time to research. More recently, the Singapore government has availed a new Clinical Trial Grant (CTG) to support clinicians in carrying out clinical trial studies for novel therapies for healthcare needs, which can also co-fund industry collaborations.Singapore government has also sponsored S$25 million Translational & Clinical Research (TCR) Flagship Programs for researchers and clinician scientists to solve scientific problems and translate their research into quality healthcare solutions for patients. Each award is for a maximum of S$10 million per program, over three to five years. The government has created an industry-government group, Biopharmaceutical Manufacturers' Advisory Council (BMAC), comprising local pharmaceutical plant site directors and government agencies. This constant dialogue between government and industry underscores Singapore's commitment to lead the manufacturing curve with a highly-skilled manufacturing workforce. 5. Are Indian pharma companies interested in investing in the pharma sector of Singapore? What kind of opportunities does Singapore provide to Indian pharma companies? In the Pharmaceuticals & Biotech sector, Indian companies can partner Singapore institutions for innovative development of new medicines, formulation capabilities and drug delivery mechanisms. Singapore has research institutes that are able to support some of their endeavors. Singapore has invested heavily in Asia-prevalent diseases such as cardiovascular disease, diabetes, gastric cancer and dengue. As some of these diseases have a high incidence in Indians, leading Indian pharmaceutical companies have expressed interest to work with Singapore clinical institutions to develop new drugs for these diseases. Indian companies will be able to tap on these research foundations to enhance their capabilities and leverage on each other's strengths in the research for these areas. We will continue to engage with Indian pharma companies to meet their evolving needs as they continue to grow their international footprint and seek external R&D collaboration opportunities. ]]> <![CDATA[Two-day symposium on 'Oncology, understanding the latest advances]]> https://biospectrumindia.com/news/95/3654/two-day-symposium-on-oncology-understanding-the-latest-advances.html https://biospectrumindia.com/news/95/3654/two-day-symposium-on-oncology-understanding-the-latest-advances.html Wed, 05 Mar 2014 12:54:00 +0530 Lambda had organized a symposium dedicated to oncology titled 'Oncology - New Horizons' as a part of its Corporate social responsibility. It was an event built around knowledge sharing and understanding the latest advances and newer modalities of treatments amidst some of the leading cancer treatment centers and top oncologists/clinicians across the world. Oncology was the focus point of the symposium as it is one of the leading maladies across the world and in India in particular. Its occurrence is growing year on year globally and, hence there is a dire need to have a focused approach in treatment modalities and continuous research to make therapy affordable, especially in developing countries like India. Envisioned by their managing director, Mrs Bindi Chudgar, the two-day long symposium, scheduled in February 2014 and was hosted at Lambda's state-of-the-art facilities in Ahmedabad. The symposium witnessed a strong international participation from guest speakers from the USA and UK, eminent oncologists from well-known centers across India, and of course senior scientists from the Indian pharmaceutical industry. Inaugurated by Mr DG Shah- secretary general, IPA and Dr Pankaj Shah, well-known hematologist and ex-director GCRI, there was a valuable sharing experience. Among the many distinguished speakers were Padmashri Dr Ashok Vaid, chairman Oncology from Medanta Cancer Institute who spoke on 'Management approach in Lung Cancer', Dr Mahesh Desai, medical director from MPUH, Nadiad who elaborated on 'Partial Nephrectomy in Kidney Tumours', Dr Vamsidhar Velcheti from Cleaveland Clinic, US and Dr Karthik Ramasamy from Oxford University, UK who gave a different and additional view of their experiences in the US and UK in treating the most difficult malady of the world. ]]> <![CDATA[QIAGEN launches careHPV Test in India]]> https://biospectrumindia.com/news/95/4742/qiagen-launches-carehpv-test-in-india.html https://biospectrumindia.com/news/95/4742/qiagen-launches-carehpv-test-in-india.html Wed, 05 Mar 2014 11:34:52 +0530 QIAGEN announced the commercial launch in India of its careHPV Test, the only molecular diagnostic for high-risk human papillomavirus (HPV). It is designed to screen women in settings with limited healthcare infrastructure, such as areas lacking electricity, water or laboratories. HPV is the primary cause of cervical cancer in women, so screening for the viral infection is a powerful strategy for prevention and early treatment of the deadly cancer. The careHPV Test was launched commercially in China in 2013 and has been used in several other countries, including as part of QIAGEN's corporate social responsibility effort, QIAGENcares. The careHPV Test for low-resource settings is highly complementary with QIAGEN's digene HC2 HPV Test, the world's most validated and sensitive diagnostic test for detection of high-risk HPV. The digene HC2 HPV Test is recognized as the "gold standard" in HPV screening and is widely used in developed countries and in large cities in emerging markets. About 72,000 women in India die of cervical cancer each year, more than one-fourth of the world's 270,000 annual deaths. In India, cervical cancer accounts for about 20% of all cancer-related deaths in women and is the number one cause of death in middle-aged Indian women. "The launch of careHPV in India will help in efforts to reduce the high burden of cervical cancer for women in India," said Dr Victor Shi, president of QIAGEN Asia Pacific. "With the digene HC2 HPV Test serving areas that have modern healthcare infrastructure and the careHPV Test serving low-resource areas, QIAGEN is expanding our role as the global leader in preventive screening for cervical cancer and continuing to contribute to women's health around the world." Dr Partha Basu, head of the department of gynecological oncology and officer in charge, Division of Preventive Oncology, Chittaranjan National Cancer Institute, noted the importance of the two-tiered approach to screening: "Based on the findings of the screening project that we have been doing for four years in Kolkata and surrounding areas, there is a need for a cost-effective and easy-to-use test which can best meet the requirements of low-resource settings. Availability of the careHPV Test is an important step forward for the prevention of cervical cancer in India." QIAGEN's robust, portable and easy-to-use careHPV Test combines the power of advanced molecular technologies with innovative design and features. For example, the system has color-coded, easy-to-understand menus and self-contained reagents. The test tolerates temperature variations that occur in rural clinics lacking refrigeration for sample storage due to limited electricity or water, and can provide results much faster. The careHPV Test was developed with support from PATH, an international nonprofit organization, and is manufactured by QIAGEN in Shenzhen, China. The careHPV Test already plays an important role in QIAGENcares, QIAGEN's collaborations with NGOs and governments in which it helps expand access to high-quality cervical cancer screening in resource-poor regions. For example, tests for cervical cancer have been conducted on women in El Salvador using the careHPV Tests since 2012. The test will also be used in other countries, including Vanuatu. Also as part of QIAGENcares, QIAGEN and the Chittaranjan National Cancer Institute (CNCI) started a five-year-program in 2010 to provide cervical cancer screening with the digene HC2 HPV Test to 50,000 women in rural West Bengal. Screening is facilitated through mobile field clinics. This project has screened more than 36,000 women to date and has detected 216 cases of High Grade Squamous Intra-epithelial Lesions (HSIL) and 52 cases of cervical cancers. Most of the cervical cancers were at early treatable stages, and more than 90% of these patients have been treated at CNCI. In addition, many doctors and community-based healthcare workers have been trained in HPV screening. This project is the first HPV based screening project in India, demonstrating program aspects and successful implementation with clear deliverables. ]]> <![CDATA[Natco wins patent dispute case against Teva]]> https://biospectrumindia.com/news/95/2996/natco-wins-patent-dispute-case-against-teva.html https://biospectrumindia.com/news/95/2996/natco-wins-patent-dispute-case-against-teva.html Tue, 04 Mar 2014 14:55:43 +0530 Based in India's Hyderabad, drug manufacturing major Natco Pharmaceuticals has won a long standing patent dispute case against Israeli drug major Teva Pharmaceuticals. The High Court of New Delhi had dismissed Teva's suit seeking an injunction over the marketing of a generic version of multiple sclerosis drug, copaxone (glatiramer acetate) in the US on February 28. Reports explained that even though Teva does not have a patent on the drug in India, the injunction sought to prevent Natco from exporting it. Adding that the decision could allow Natco to launch generic version of Teva's Copaxone in the US, the report said that this could be subject to approval from the US Food and Drug Administration (USFDA). The patent on the $4 billion sales drug, expires in the US on May 24, 2014. ]]> <![CDATA[DBT's technological intervention to improve maternal health ]]> https://biospectrumindia.com/news/95/6900/dbts-technological-intervention-to-improve-maternal-health-.html https://biospectrumindia.com/news/95/6900/dbts-technological-intervention-to-improve-maternal-health-.html Tue, 04 Mar 2014 14:52:00 +0530 As clearly outlined by the DBT, the proposal should be aimed at diffusion of new and tested interventions, increasing the awareness among the community and training the rural health workers, developing low cost easy-to-use diagnostics/point of care technology etc. It has been also mentioned that the proposals with new thinking and having a well-articulated work plan will be encouraged. The few examples in that case are the developing of low cost point of care technology for new-borns, such as respiratory counter, mobile miniature pulse oximetry, point of care diagnostics for detection of new-born sepsis etc.; simple and affordable solutions for newborn resuscitation. However, the funding will not be considered for infrastructure development, basic research or solely R & D proposals, educational/awareness generation activities without any technological interventions and technologies that are not useful in low-resource setting The projects will be supported to universities, national labs, autonomous institutions and colleges, voluntary organizations, NGOs, social trust, foundations etc. In case of NGOs and private organizations, the projects should be submitted in collaboration with other gvernment funded agencies/ institutes with proven track record etc. The NGOs should be duly registered for minimum last five years and should have experience in implementing such projects at community level. The proposals will be examined by a DBT constituted expert committee and only shortlisted proposals will be intimated for presentation before the Task Force committee for consideration of financial support by DBT. The proposals have to be submitted online through DBT eproMIS website (http://dbtepromis.nic.in/login.aspx) under the Programme Area "Biotechnology Based programme for Women" and later through hard copies latest by April 15, 2014. In studies wherever ethical clearance is required, the same may be obtained from the competent body and submitted within one month of proposal submission. ]]> <![CDATA[New enzyme technology increases yield, decreases energy consumption ]]> https://biospectrumindia.com/news/95/3650/new-enzyme-technology-increases-yield-decreases-energy-consumption-.html https://biospectrumindia.com/news/95/3650/new-enzyme-technology-increases-yield-decreases-energy-consumption-.html Tue, 04 Mar 2014 11:48:00 +0530 This enzyme is said to help starch processors make significant cash savings through increasing yield and reducing energy, water and chemical use. The solution is designed to break down starch in a way that creates more dextrose compared to conventional alpha-amylases, resulting in higher yields, and chemical, water and energy savings. The combined benefits can enable a starch processor save up to 1 USD per metric ton of substrate. "LpHera brings the liquefaction pH level as low as 4.5-4.8. This means you can reduce your use of pH chemicals in some instances by more than 50%," says Mr Thomas Nilsson, global launch manager for food, Novozymes. "It also prolongs the ion exchange service cycle, which in turn enables more savings on chemicals, water and wastewater." Running at pH 5.5, the enzymes used for conventional starch liquefaction require addition of chemicals to raise pH levels before liquefaction. Chemicals are added again at the end of the process to ensure lower pH, necessary for the next step in starch processing, i.e., saccharification. Liquefaction with LpHera also increase dextrose yields by 0.2 % points. As starch customers process large amounts of starch every day, this is seen to be significant. "Starch plants vary in size and can process from 0.2 to over 1 million ton of substrate each year," says Mr Thomas Nilsson. "So if a plant processes 0.5 million ton of substrate, the additional yield coupled with the energy, water and chemical savings associated with LpHera means that such a plant can save up to 0.5 million dollars per year compared to today's technology." "We see LpHera as bringing value beyond liquefaction," explains Mr Thomas Nilsson. "Producers of high fructose syrup benefit from more efficient evaporation and water and energy savings. In crystalline dextrose production, it ensures higher crystallization yield, and when producing fermented products, it achieves higher yield and better byproducts with lower salt levels. LpHera is just the beginning of new and needed innovation for the starch industry." ]]> <![CDATA[Jubilant sells its hospital business]]> https://biospectrumindia.com/news/95/3111/jubilant-sells-its-hospital-business.html https://biospectrumindia.com/news/95/3111/jubilant-sells-its-hospital-business.html Tue, 04 Mar 2014 10:55:00 +0530 Jubilant First Trust Healthcare (JFTH), a wholly owned subsidiary of Jubilant Life Sciences sells its hospital business to Narayana Health. JFTH operates two hospitals in West Bengal, Kalpataru in Barasat and Rabindranath Thakur in Berhampore. The business has been transferred on a going concern basis as a slump sale which will enable Jubilant Life Sciences to focus on its core businesses in Pharmaceuticals and Life Sciences. Commenting on the occasion, Ms Aashti Bhartia, director Jubilant First Trust Healthcare said, "We entered the hospital business with the vision to build high quality and affordable healthcare. We are happy to hand over the hospitals to Narayana Health, whom we are confident of taking the vision forward." Speaking on the occasion, Dr A Raghuvanshi, vice chairman, MD and Group CEO, Narayana Health said, "The acquisition of Jubilant First Trust Healthcare's hospital business in West Bengal is part of our strategic growth plan for East India. We have plans to upgrade the facilities at Jubilant Kalpataru Hospital in Kolkata to offer tertiary level super-speciality care in four to six months." He further added, "We are glad to include these hospitals into our network and reinforce our commitment to West Bengal in bringing high-class super-speciality healthcare services within the reach of the common man." ]]> <![CDATA[Inactivated polio vaccines broadly available for the World's children ]]> https://biospectrumindia.com/news/95/3587/inactivated-polio-vaccines-broadly-available-for-the-worlds-children-.html https://biospectrumindia.com/news/95/3587/inactivated-polio-vaccines-broadly-available-for-the-worlds-children-.html Mon, 03 Mar 2014 19:09:29 +0530 Sanofi Pasteur, the vaccines division of Sanofi, announced its further commitment to the international community's efforts to complete polio eradication. UNICEF, the organization that procures the vaccine to meet global needs, announced it will purchase significant quantities of Inactivated Polio Vaccine (IPV) from Sanofi Pasteur and make it available based on country needs and vaccination plans. To achieve the goal of polio eradication by 2018, the World Health Organization (WHO) recommends that by end 2015, all children receive routinely at least one dose of IPV in over 120 countries that solely use Oral Polio Vaccine. In order to support rapid and widespread adoption of IPV, Sanofi Pasteur - the world's largest producer of IPV - and the Bill & Melinda Gates Foundation have developed a joint price support mechanism, including a financial contribution from both organizations. This mechanism allows Sanofi Pasteur to offer IPV at a price of â‚¬0.75 per dose (approximately US$ 1) to 73 of the world's poorest countries. The GAVI Alliance, a global immunisation partnership, will make IPV available for inclusion in routine immunisation schedules in these countries. This announcement underscores Sanofi Pasteur's commitment to offer unparalleled volumes of high-quality IPV across a broad range of countries and economic situations at differential prices in an unprecedented, global rollout. "The World Health Organization welcomes today's announcement to reduce the cost of this effective polio vaccine, it is a significant step forward in the fight against polio." said Dr Margaret Chan, director-general of WHO. "This development is a strong signal that polio eradication partners remain fully committed to a world without polio." "Reducing the price of IPV for the world's poorest countries is helping remove the cost of the vaccine as a barrier to achieving a polio-free world. This is a significant advancement to ensure every child, no matter where they live, will benefit from access to this essential vaccine," said Bill Gates, co-chair of the Bill & Melinda Gates Foundation. "The people of Sanofi Pasteur are proud to help the world get rid of polio, as part of our public health mission," said Olivier Charmeil, the ceo of Sanofi Pasteur. "Thanks to our longstanding commitment to polio eradication - in partnership with WHO, UNICEF, GAVI, CDC, Rotary International and the Bill & Melinda Gates Foundation - we are making it possible to finish the job," he added. "Today marks a big step forward in the global effort to tackle polio by accelerating the universal use of Inactivated Polio Vaccine," said Dr Seth Berkley, ceo of the GAVI Alliance. "We expect the first countries will introduce IPV with GAVI support later this year. We are entering an exciting phase for polio and new efforts to strengthen routine immunisation which should see even more children benefit from the power of vaccines." The introduction of IPV, a vaccine that has been used in the majority of the developed world for years, in 120 countries is a necessary step toward achieving a polio-free world by 2018. The GPEI Endgame Strategic Plan 2013-2018, which was endorsed by 194 countries in 2013, offers a comprehensive roadmap that includes ending polio transmission, improving routine immunization rates and creating a lasting blueprint for addressing other significant global health challenges. Introducing at least one dose of IPV and switching progressively over the next few years from an oral polio vaccine (OPV) to IPV is critical to ending transmission and improving immunization rates. Because OPV contains a very weakened form of the live polio virus, the global plan calls for OPV to be progressively replaced with the inactivated, injectable vaccine as the world moves into the final stages of polio eradication. ]]> <![CDATA[India makes OPV mandatory for travelers from seven polio affected nations]]> https://biospectrumindia.com/news/95/6051/india-makes-opv-mandatory-for-travelers-from-seven-polio-affected-nations.html https://biospectrumindia.com/news/95/6051/india-makes-opv-mandatory-for-travelers-from-seven-polio-affected-nations.html Mon, 03 Mar 2014 17:53:00 +0530 All travelers coming from these countries to India would need to take OPV six weeks before departure from their country. Polio vaccine will also be administered to all travelers from India to these polio-affected countries. The new polio vaccination regime comes into effect from 1st March, 2014. "Years of efforts and huge financial resources have been invested by India for stopping polio in India. We cannot risk importation of poliovirus, which is getting bigger and bigger with the recent outbreaks in the Middle East and earlier in the horn of Africa region. This new preventive measure has been initiated as per the recommendations of the national and international expert bodies and the guidelines of the World Health Organization" said Ms Anuradha Gupta, additional secretary, ministry of health and family welfare, government of India. India has not reported any case of polio for over 3 years. Next India, along with the remaining countries ofWHO's South East Asia region will be certified polio-free. However, the risk of polio persists as Afghanistan, Pakistan and Nigeria continue to be polio-endemic, re-infecting six countries in 2013 and causing major polio outbreaks in the Horn of Africa region and the Middle East. In view of the persisting threat of polio virus importation, the Independent Monitoring Board of the Global Polio Eradication Initiative, recommended in its October 2013 report that the International Health Regulations (IHR) should be used to ensure all people travelling from polio-endemic country are required to have vaccination prior to travel, and this should be extended to any persistently affected country. As per the WHO guidelines, until polio is eradicated globally, the risk of introduction of poliovirus in polio-free areas through travelers remains. All travelers, to and from poliovirus-infected areas, are advised to be adequately vaccinated. WHO Representative to India, Dr Nata Menabde, said, "World Health Organization supports the Government of India initiative for making polio immunization a requirement for travelers from and to the polio-affected countries. This is also in line with the recommendation of the Independent Monitoring Board of the Global Polio Eradication Initiative." Earlier, in May 2013, the India Expert Advisory Group (IEAG) on Polio Eradication recommended that the Government of India should strongly promote the current WHO polio immunization recommendations for travelers to and from endemic or infected areas. The expert body had said that the most significant risk is the importation of poliovirus from remaining countries with endemic circulation. Additionally, the possibility of outbreaks in non-endemic countries leading to spread that threatens India could not be discounted. India is taking several other measures to mitigate the risk of poliovirus importation. Continuous polio immunization posts have been set up along the international borders with Pakistan, Nepal, Bangladesh, Myanmar and Bhutan. Initiated in 2011, the number of posts has gone up to 102 this year with nearly 4.2 million children immunized at these posts in the last two years. All efforts are being madeto maintain population immunity against polio through high quality polio immunization campaigns and increased routine immunization coverage. Two national and six sub-national polio campaigns were held in 2013. High quality surveillance is in place to detect any untoward importation of the poliovirus into India. The Government of India has declared that any case of poliovirus would be treated as an emergency. The emergency preparedness and response capacity is being reviewed on an ongoing basis and nearly 200 Rapid Response Team members have been trained to roll out emergency response to polio. ]]> <![CDATA[Following FDA warning, Jubilant resolves quality issues]]> https://biospectrumindia.com/news/95/5827/following-fda-warning-jubilant-resolves-quality-issues.html https://biospectrumindia.com/news/95/5827/following-fda-warning-jubilant-resolves-quality-issues.html Sat, 01 Mar 2014 10:02:00 +0530 Jubilant Life Sciences has received a communication from the U.S. Food and Drug Administration (FDA), classifying its pharmaceutical manufacturing facility at Montreal, Canada as 'Acceptable'. The company announced the same on February 28, 2014. "This resolves all issues raised by the FDA on the facility in February 2013 and subsequent communications. The development follows completionof FDA's review of the Company's responses post the February letter and the subsequent re-inspection conducted at Jubilant's Montreal facility in September, 2013. This development successfully resolves the FDA issues at our Montreal facility,"mentioned the statement from the Jubilant. ]]> <![CDATA[Indus Health Plus bags ASSOCHAM CSR Excellence Award ]]> https://biospectrumindia.com/news/95/3647/indus-health-plus-bags-assocham-csr-excellence-award-.html https://biospectrumindia.com/news/95/3647/indus-health-plus-bags-assocham-csr-excellence-award-.html Fri, 28 Feb 2014 15:37:20 +0530 ASSOCHAM honored Indus Health Plus with the CSR Excellence Awards in SME and other categories in recognition for the outstanding CSR activities undertaken by the company. Mr Harish Pillai, CEO, Indus Health Plus recently received the award by Mr Kapil Sibal, Communication Minister at Hotel Leela in New Delhi. CSR is the integration of business operations and values, whereby the interests of all stakeholders including investors, customers, employees, the community and the environment is reflected in the company's policies and actions. Indus Health Plus bagged this award as its business revolves around CSR, sustainable development and corporate citizenship. This is achieved through special discount coupons for senior citizens on preventive healthcare check-ups. Indus also conducts number of seminars and workshops pan India to generate awareness, through delivery channels. Special citizen camps, police camps, blood donation camps, society checkups are part of CSR activity by Indus. Mr Harish Pillai, CEO Indus Health Plus said, "We are extremely happy and honored to receive the ASSOCHAM award for our CSR initiatives which we believe in and conduct throughout the year. The entire Indus team thanks the jury members for selecting us as the winner in this category. Our aim has been to provide quality healthcare at affordable prices to the masses through preventive healthcare checkups. We would continue with our CSR activities and expand it further to a larger outreach in days to come. A recognition as this would surely take us further ahead and we would continue serving the society by our initiatives." ]]> <![CDATA[Will political parties pay heed?]]> https://biospectrumindia.com/features/95/5776/will-political-parties-pay-heed.html https://biospectrumindia.com/features/95/5776/will-political-parties-pay-heed.html Fri, 28 Feb 2014 11:16:00 +0530 In the previous issue, we did a special story on the industry's expectations from the next government at the centre and also the missing bioscience agenda on political landscape. Following that, we sent the print and e-copies of the story to the manifesto committees of the major political parties. Although we didn't elicit any direct response from them, we did receive oral assurances from the few representatives. The main purpose behind the entire exercise was to generate awareness about the aims and aspirations of the industry and its associations. The key highlight that emerged out of it was the decisiveness with which the next government will act on the pending regulatory issues and promotion of the sector. The experts were unanimous in one voice that they want the political diaspora to understand the needs of the biotech industry to ensure the best outcomes especially in healthcare and agriculture. Given the fact that it is completely different from other sectors due to its direct effect on the wellbeing and livelihood of the common people, many associations felt that the government must offer the exemption from excise or custom duties on life saving medicines as well as on their raw materials and also on capital goods and consumables. The complex regulatory scenario and prevailing confusion has added to the woes of experts who have to always run from pillar to post for seeking clearances. No doubt ensuring the safety and well-being of people is supreme but that has to be based on logic and not unfounded emotional misconceptions. There have been individual government agencies and officials who have indeed worked tirelessly to promote the sector. However, the lack of coordination and unanimity on key issues within the outgoing government came as great disappointment for them. While at the moment, we are not sure about the political party forming the next government at the centre but we are confident that the political ideology will guide most of the decisions. The public perception surely is important for any democratic government but so is the long term vision for their betterment. And unfortunately the lack of enough knowledge about this industry in the general public has become a negative factor. Perhaps the industry requires to establish a direct connect and open a dialogue with the common masses. The mobilization of strong public opinion can surely force any political party to make amends to the rigidity of few outdated principles. As one of the political analysts had pointed out, the political parties will keep following populist themes and if you have to make them see your point, you have to make it positively popular. The message has been delivered and now is the time to wait and watch. As the nation awaits the next dispensation to take over the reins, the industry too will curiously look on for the recognition and special attention. ]]> <![CDATA[Moily clears GM crops field trials ]]> https://biospectrumindia.com/news/95/3636/moily-clears-gm-crops-field-trials-.html https://biospectrumindia.com/news/95/3636/moily-clears-gm-crops-field-trials-.html Fri, 28 Feb 2014 10:46:00 +0530 The last kharif season saw no clarity on the sowing of GM seeds due to lack of political will on the part of the government. This made the agri-biotech companies who were allowed to hold the confined trials after no objection certificate from the states by the Genetic Engineering Appraisal Committee (GEAC) to keep their fingers crossed. During its last meeting held one year ago on March 2013, GEAC had given green signal for the field trials of as many as crops but was withheld by the then environment minister, Ms Jayanthi Natarajan. However, after the prime minister asked her to go, the new environment minister Mr Veerappa Moily took few immediate decisions on some pending issues. Within two months of his joining, Moily has finally on February 27, 2014 approved the March, 2013 decision of the GEAC to allow more than 200 successful gene modification trials for rice, wheat, maize, castor and cotton. The minister has also called a meeting of the GEAC on March 21, 2014, a year after it last met and cleared the field trials. In its last meeting, GEAC had given Bayer Bioscience an open-ended clearance to test GM rice in all four regions of the country after consent of state governments. It gave permission to Bayer to conduct selection trials on 45 transgenic rice events, comprising six genes. Mahyco and BASF India were allowed to conduct trials of GM rice while Hyderabad-based Directorate of Oilseeds Research's GM castor had been re-approved for field trails. Monsanto India was permitted to test its GM maize at alternate sites after facing protests in several states. Similarly, Mahyco was also given an extended clearance for GM wheat trials. Apart from that, the GEAC had also cleared field testing of various GM cotton varieties by Bayer, BASF and Mahyco. The biotech industry body, Association of Biotechnology Led Enterprises- Agriculture Group (ABLE-AG) also welcomed the positive attitude of the new environment minister. Mr Ram Kaundinya, chairman, ABLE AG added, "It is encouraging that the minister has approved the March,2013 decision of GEAC. This is a progressive step and will clear the path for the unhindered progress of R&D in the vital agriculture sector." "ABLE-AG firmly believes that research and trials in GM technology should not be stopped as additional information from research and trials will help us to assess the technology more accurately. it was very discouraging that the GEAC mechanism had come to a half for the last two years," mentioned the statement from ABLE AG. Prior to that even prime minister had openly batted for the GM crops. While speaking at the Indian Science Congress held at Jammu, Dr Manmohan Singh had asked the scientists to communicate their ideas in a much vocal manner. "To ensure food security and to improve land and water productivity, we have to launch a national drive for an ever-green revolution. This will test the ingenuity of our agricultural scientists. Climate-resilient agriculture and modern bio-technological tools hold great promise. Use of bio-technology has great potential to improve yields", said Dr Singh. ]]> <![CDATA[ABLE-AG welcomes approval to GM crops field trials]]> https://biospectrumindia.com/news/95/3627/able-ag-welcomes-approval-to-gm-crops-field-trials.html https://biospectrumindia.com/news/95/3627/able-ag-welcomes-approval-to-gm-crops-field-trials.html Fri, 28 Feb 2014 10:35:00 +0530 On February 28, 2014 in a press meet at New Delhi, the union environment and forest minister, Mr Veerappa Moily approved the March, 2013 decision of the GEAC to allow more than 200 successful gene modification trials for rice, wheat, maize, castor and cotton. Reacting to the development, ABLE-AG expressed its happiness on the government decision. The long-awaited next meeting of GEAC is now scheduled for March 21, 2014. "We are hopeful that the next GEAC meeting will clear the new applications before the coming Khariff season," said Ram Kaundinya, chairman, ABLE AG while welcoming Moily's announcements. Dr N Seetharama, executive director ABLE-AG said, "We laud Shri Moily's reaffirmation of his faith in the power of technology. At a time when agriculture is under severe stress and requires immediate infusion of technology and innovation, we can't afford to ignore biotechnology which has a proven track record of enhancing crop yields in a safe and sustainable way the world over". Kaundinya added, "It is encouraging that the Hon'ble Minister has approved the March 2013 decision of GEAC. This is a progressive step and will clear the path for the unhindered progress of R&D in the vital agriculture sector." ABLE-AG firmly believes that research and trials in GM technology should not be stopped as additional information from research and trials will help us to assess the technology more accurately. it was very discouraging that the GEAC mechanism had come to a half for the last two years. "We appreciate the agriculture minister's firm stand on the issue and the Environment Minister's progressive approach towards GM technology. We have been pleading with the Government to allow the field trials. Now we are sure that the March 21 GEAC meeting will provide much awaited relief to the industry and the trials will happen in this Kharif season", added Mr Kaundinya. ]]> <![CDATA[We will back field trials of GM crops : Sharad Pawar ]]> https://biospectrumindia.com/news/95/3632/we-will-back-field-trials-of-gm-crops-sharad-pawar-.html https://biospectrumindia.com/news/95/3632/we-will-back-field-trials-of-gm-crops-sharad-pawar-.html Thu, 27 Feb 2014 18:15:00 +0530 Speaking at the two-day national conference on agriculture for kharif campaign on February 26, 2014, the union agriculture minister, Mr Sharad Pawar reaffirmed the government's commitment to promotion of bio-technology for agriculture development. "We have to accept the fact that there is little scope of area expansion for agriculture. In fact, the burden on land is bound to increase. We have to meet the burgeoning demand of food grains, fruits, vegetables, etc. from the limited land base. The only mantra is the increasing the productivity. The use of bio-technology for this purpose is imperative. Bio-technology has great potential to improve yields. Government is committed to the use of bio-technology and other new technologies for agriculture development and backs field trials of GM crops with 'crop-specific dedicated monitoring protocols system,'' remarked Mr Pawar. ]]> <![CDATA[WHO study credits Indian temp proof vaccine for reducing Meningitis in Africa ]]> https://biospectrumindia.com/news/95/3631/who-study-credits-indian-temp-proof-vaccine-for-reducing-meningitis-in-africa-.html https://biospectrumindia.com/news/95/3631/who-study-credits-indian-temp-proof-vaccine-for-reducing-meningitis-in-africa-.html Wed, 26 Feb 2014 16:04:00 +0530 For more than 100 years, sub-Saharan Africa has suffered from meningitis A epidemics that claim thousands of lives. In 1996 and 1997, an epidemic killed more than 25,000 people and sickened 250,000. Those who survive often suffer from deafness, epilepsy, loss of limb, and mental retardation. The MenAfriVac vaccine, which is manufactured by Serum Institute of India, Is already saving lives along Africa's meningitis belt. Since 2010, more than 150 million people aged 1 to 29 years in 12 countries have received the vaccine with not a single group A meningitis case identified in the vaccinated populations. By the end of the 2013 epidemic season, the number of meningitis cases in the belt was the lowest in ten years, a decrease attributed to the introduction of MenAfriVac. By 2016, the vaccine initiative aims to have reached more than 250 million people across the 26 countries in the meningitis belt. Established in 2001, the Meningitis Vaccine Project is a partnership between PATH and the World Health Organization. Its mission is to eliminate epidemic meningitis as a public health problem in sub-Saharan Africa through the development, testing, introduction, and widespread use of conjugate meningococcal vaccines. The first mass vaccination campaign conducted in Africa with a vaccine that does not require constant refrigeration succeeded in providing complete coverage while ensuring the vaccine stayed viable even in ambient temperatures up to 39°C (102.2°F), according to a study published online today in the journal Vaccine. Conducted as part of a ten-day meningitis A vaccination campaign in Benin in November 2012, the study represents a breakthrough not only for the vaccine, MenAfriVac®, but potentially for increasing the efficiency, coverage, and affordability of other lifesaving vaccines as well, especially in remote, hard-to-reach areas where keeping the vaccine cold is difficult. Researchers with Optimize, a now-completed collaboration between the World Health Organization (WHO) and the global health nonprofit PATH, cooperated with the government of Benin to implement the study. If widely used, this approach could significantly reduce the workloads of health workers, who spend vast amounts of time maintaining the cold chain, and extend vaccines to areas that are so far removed from access to electricity they could never be reached by a cold chain system, the study found. Additionally, a separate study published in the Bulletin of the World Health Organization on the economic benefits of this approach found that the costs of administering the MenAfriVac vaccine without keeping it cold could drop by 50 percent. ]]> <![CDATA[BioAsia 2014: Innovation, collaboration identified as success keys]]> https://biospectrumindia.com/features/95/7753/bioasia-2014-innovation-collaboration-identified-as-success-keys.html https://biospectrumindia.com/features/95/7753/bioasia-2014-innovation-collaboration-identified-as-success-keys.html Tue, 25 Feb 2014 17:56:00 +0530 The guests of honor comprised of Dr Lino Baranao, Hon'ble Minister, Ministry of Science & Technology, Argentina; Mr Kim Sang-Pyo, Hon'ble Vice Governor, Gangwon Province, Republic of Korea; Dr Antonio Juan Bonfatti, Hon'ble Governor, Santa Fe, Argentina; Mr Patrick Suckling, Hon'ble Australian High Commissioner; and Mr Andrew McAllister, Hon'ble British Deputy High commissioner. During the inaugural ceremony, Dr K V Raghavan, chairman of BioAsia's organizing committee, scientist and emeritus and former director, Indian Institute of Chemical Technology, Hyderabad, said, "The decade saw an outstanding success in attracting international partners, breaking innovation and business opportunities at the doorsteps of biotechnology industry in India. Over 60 percent of the participants here are from pharmaceutical and biotechnology companies and 15 percent of them are CROs and CMOs." The key note was delivered by Mr G V Prasad, chairman and CEO, Dr Reddy's Laboratories, and Mr Chris Stirling, global head, life sciences, KPMG, UK. Mr Andrew McAllister in his speech added, "We will be exploring opportunities in the life sciences sector, sharing knowledge and conducting businesses. This is an auspicious start. The UK's relationship with India at social level is of tremendous importance. The Indian diaspora is larger than any other minority community in the UK. The Indian life sciences is engaged in world-class work." Mr McAllister recalled that Andhra Pradesh has a good infrastructure which attracts investors from all over the world. "UK life sciences companies are well represented in India. The R&D fair in national labs and in various life sciences clusters in Bangalore, Ahmedabad, Mohali and Hyderabad are building ecosystem needed for drug discovery and innovation in life sciences," added Mr McAllister. For the UK, according to Mr McAllister, the life sciences is a priority. "The commitment directly comes from the UK's Prime Minister's office. There is wider focus on getting more investor in this sector. We have four of the world's leading Universities and a well-established sophisticated R&D manufacturing and supply chain ecosystem," he said. He believes that the government, academia, and industry can ensure the practical applicability of pure sciences to develop high-end products, whose benefit can be shared nationally and internationally. "The UK is a great place to conduct efficient R&D. Research and knowledge transfer is increasing internationally. We want to internationally bring the best-in-the-world researchers and access international facilities, which is the basic foundation for success and the relationship between India and the UK is significant. By combining our strengths and ideas, our chances of success increases exponentially. We in the UK offer an environment that welcomes companies and steer them through and help find suitable partners," he opined. Mr Patrick Suckling in his speech commented, "The key message from the Australian government is that it is committed to do business-friendly activities. Its continuing economic refocus has made Australia a global performer for the last few decades. India is our fifth largest export market. Indian companies are investing in Australia and about $10 billion went in to our economy last year from companies, including GVK and Tech Mahindra." Mr Suckling emphasized that Australia serves as an attractive business partner for varied reasons. "We have a strong ecosystem and a proven track record. We are committed to R&D. Australia is strategically located composed of multi-cultural workforce. India stands as the second largest group of people in Australia. Our country is well positioned with strong R&D base, which is mutually beneficial to the people of India and Australia," he explained. In his keynote address, Mr G V Prasad added, "Innovation is an over-used word. We have moved to knowledge-era where IP and creating winning ideas and the power of ideas drive value creation. We have to focus and build our research in academic institutions and remove barriers to attract global talent. We should increase global capita, be tolerant to failures, and design and implement policies to enable innovation in biotechnology." He further added, "With achievements in the biotechnology, we can help our farmers much. Without biotechnology, we would have had large famines in our country. We can leverage this technology to reduce harmful effects of pesticides. This is good for the climate and sustainability." Talking about the advances in genomics, Mr G V Prasad added, "Genomics has resulted in personalized medicine, gene therapy, predictive diagnostics, bone replacement and growing organs through stemcells." "And, by sharing clinical data and medical records, and applying tools on the big data, we can understand diseases well and develop much better medicines," he commented. India is said to be the largest producer of vaccines in the world. "This is possible because of the strong drive in the innovation and positive support from policy-makers. Drugs from India is helping countries lower their budgets. We have been keeping prices lower to make them accessible to all sections of the society. We have helped South America and Africa to tackle AIDS, and provide vaccines to the world across various geographies. Innovation has made this possible for making alternate versions of products discovered elsewhere at better costs," emphasized Mr Prasad. He continued stating that, "We do not patent cutting-edge innovative products yet in the life sciences and IT industry. We have helped other countries innovate. It is time for us to bring these skills together and move to the highest kind of innovation in the value chain." According to Mr Prasad, innovation amounts to 70 percent of the value chain today. "To address this, we need to fix higher education in research institutions and universities and increase access to risk-capital and be tolerant of failures and support government policies." Commenting on India's existing turmoil in the area of clinical trials, he stated, "Clinical trials in India is not easy. It is extremely complex and hard to get clearances. Investors are looking for short-term and immediate profits. This has to be addressed if you need to pursue innovation to make innovative products." "With emphasis on higher education and research in universities, high risk-capital, tolerant to failures, supportive governmental policies, we can get there," he summarized. Another keynote speaker, Mr Chris Stirling, expressed that the current industry model doesn't put patients at the heart of its decision-making. "Judgments are influenced by developments and block-buster products, which are expected to drive block-buster returns for shareholders," he said. Mr Stirling also was heard quoting the New England Journal of Medicine that, "Over 50 percent of the drugs have not demonstrated any tangible patient benefits." He also commented that, "Putting patients in the center will move the industry. About 90 percent of the healthcare budget is spent on services and infrastructure, and only 10 percent is spent on drugs. Mr Stirling advised by saying, "Companies need to implement three fundamental steps. First is to promote new business models since traditional research model is not working as it used to be. The return on R&D has fallen from the industry's average of 20 percent twenty years ago, to an average of 10 percent now. Secondly, prioritizing patients' perspective is important to better understand patients, which allows development of innovative patient-centered treatments. Research should address the patients' needs and not just symptoms. Thirdly, we need to foster a culture of collaboration, since it is just as important as innovation." He concluded by opining, "The healthcare landscape is changing everywhere and life sciences companies need to realize that. Life sciences is global in nature but healthcare systems are local. The game is changing. Finding solutions to succeed in this new landscape is not easy. A lot of innovation is required which is focused on patients." Countries that participated in the BioAsia 2014 included China, Singapore, Sri Lanka, Pakistan, Iran, US, Scotland, Australia, and Belgium. The principal country partner for this event was UK and the international state partners included Santa Fe province of Argentina and Gangwon of South Korea. The event was organized by Federation of Biotech Association, Pharmaceuticals Export Promotion Council (Pharmexil) and Government of Andhra Pradesh. (Raj Gunashekar in Hyderabad, Andhra Pradesh.) ]]> <![CDATA[ Need to scale up treatment for TB control:President]]> https://biospectrumindia.com/news/95/7058/-need-to-scale-up-treatment-for-tb-controlpresident.html https://biospectrumindia.com/news/95/7058/-need-to-scale-up-treatment-for-tb-controlpresident.html Mon, 24 Feb 2014 13:05:00 +0530 The President of India, Pranab Mukherjee inaugurated the National Conference on tuberculosis (TB) and Allied Diseases (NATCON) at Rashtrapati Bhavan Auditorium on (February 23, 2014). Speaking on the occasion, the President said that global TB control is unattainable without controlling the incidence of TB in India. Nearly 20 years after WHO's declaration of Tuberculosis as a global public health emergency, major progress has been made towards attainment of the global targets defined in the context of the Millennium Development Goals. India has been an able partner in this progress. The President stated that the Revised National Tuberculosis Control Programme (RNTCP) has become one of India's largest public health achievements. The endeavor should now be to aim for universal access focusing on improved diagnosis of TB patients through improving outreach, vigorously expanding case-finding efforts among vulnerable sections of the society, deploying better diagnostics, and extending services to patients diagnosed and treated in both the public and private sectors. He said that the emphasis also has to be on improving patient-friendly access to high-quality treatment for all diagnosed cases of TB, including scaling-up treatment for Multi-Drug Resistant-TB nationwide. He called upon all stakeholders to commit themselves to continue to do their best for instituting health care systems in the country which are equitable, affordable and accessible by all sections of the society. ]]> <![CDATA[Amputation saves 13-year-old girl from massive cancerous]]> https://biospectrumindia.com/news/95/3628/amputation-saves-13-year-old-girl-from-massive-cancerous.html https://biospectrumindia.com/news/95/3628/amputation-saves-13-year-old-girl-from-massive-cancerous.html Mon, 24 Feb 2014 11:12:08 +0530 When 13-year-old Ms Percy (name changed), the only child of her parents, was suffering from frequent falls and pain in her leg, her parents took her to a doctor for checkup. Initial diagnosis through an X-ray showed lesion over her femur (thigh bone) area. Later, a biopsy was performed, which revealed a massive cancerous growth (Osteogenic sarcoma - a form of bone cancer) in her femur (thigh bone). She was started on chemotherapy after diagnosis at a local hospital. But after three months and no improvement in her condition, an amputation of the limb seemed imminent. In a complex 8 hour surgery, a limb salvation surgery was performed on her by consultant orthopedic oncologist, Dr Agarwal, assisted by Dr Amol Dongre, medical oncologist and Dr Manoj Pahukar, orthopedic surgeon, from Wockhardt Hospital, Nagpur. Initial tests at Wockhardt Hospital, Nagpur, revealed that the tumor had metastasized (was spreading). Examination of the affected limb revealed tense shiny skin with discharging sinus, she had developed severe infection at the site of main tumor. Considering her young age, it was important to salvage her limb and ensure that the infection does not spread to other parts in the body. Talking about the complications of the case, Dr Agarwal, consultant, orthopedic oncologist, said, "This case was complicated not only due to the young age of the patient, but also because of the infection she had and the massive size of the tumor in her body. Fortunately, she has responded well to the treatment, and will hopefully have a good quality of life." Ms Percy was first started on antibiotics and after few weeks of treatment, her infection subsided and she was started on chemotherapy. A surgery was then performed for removing the tumor from her bone. The femur, which is the longest bone in the body, was infected by more than 80%. The size of the tumor was more than 30 cm over the 37 cm femur. Futher on, the removal of the bone, a spacer was placed in the leg to suppress infection. Later on, her chemotherapy was continued and a prosthetic was inserted in the leg after removing the spacer. The patient has recovered well, is practically cured of her malignancy with an intact limb. Dr Amol Dongre, medical oncologist, Wockhardt Hospital, Nagpur, said," Since she suffered from infection, it was not possible for us to start treatment before reducing her infection. Chemotherapy would not have worked then. After reducing the infection, we have given her some cycles of chemotherapy. Since her response to chemotherapy has been good, we hope that the cancer would not resurface." ]]> <![CDATA[Jubilant expands drug discovery alliance with Janssen ]]> https://biospectrumindia.com/news/95/3624/jubilant-expands-drug-discovery-alliance-with-janssen-.html https://biospectrumindia.com/news/95/3624/jubilant-expands-drug-discovery-alliance-with-janssen-.html Fri, 21 Feb 2014 12:59:53 +0530 Jubilant Biosys, a Bengaluru based subsidiary of Jubilant Life Sciences, announced on February 21, 2014 that it has expanded its drug discovery alliance with Janssen Pharmaceutica N.V., Beerse, Belgium. The alliance was forged initially in the year 2011 and aims to deliver preclinical candidates to Janssen. The new agreement into multiple therapeutic areas has been expanded owing to Jubilant's diversified skill sets in various therapeutic areas. Most of the research will be undertaken at Jubilant Biosys, India and some parts at Jubilant Discovery Center, USA. Janssen Pharmaceutica, Belgium is part of the 'Janssen Pharmaceutical Companies of Johnson & Johnson'. The collaboration between the two organizations has been expanded to leverage Jubilant's drug discovery capabilities on selected drug discovery targets to advance programs in multiple disease areas. Jubilant will carry out research services and will deliver preclinical candidates to Janssen for potential development and commercialization. In addition to research funding, Jubilant will also receive milestones and royalties should Janssen successfully progress the assets into clinical development and commercialization. "We are pleased to announce the expansion of the Janssen- Jubilant collaboration and look forward to discovering Novel Chemical Entities (NCE's) that address the unmet medical needs in these important disease areas", said Dr Subir K Basak, president, Jubilant Biosys (Global Drug Discovery Services)". Over the past several years, we have been strengthening our disease franchises from a scientific perspective, and this collaboration serves as a validation of those efforts. We look forward to a long, and mutually beneficial, partnership." Jubilant provides comprehensive drug discovery solutions from target discovery to IND in partnership with leading healthcare companies worldwide, offering integrated & collaborative drug discovery services across early discovery, synthetic and medicinal chemistry including scale up and pre-clinical services. Jubilant houses eminent scientists who carry with them rich experience from global pharmaceutical companies and academic institutions. The company is one of the leading service providers in Protein X-Ray crystallography in India, which in combination with medicinal chemistry and computational chemistry provides a powerful Structure Based Drug Design platform and a best niche platform to build and drive Structure Activity Relationship (SAR) for various discovery programs. Jubilant has been a partner to some of the major large and mid-size pharma and Biotech companies. ]]> <![CDATA[Experts join hands for a collective vision on healthcare future]]> https://biospectrumindia.com/news/95/3634/experts-join-hands-for-a-collective-vision-on-healthcare-future.html https://biospectrumindia.com/news/95/3634/experts-join-hands-for-a-collective-vision-on-healthcare-future.html Fri, 21 Feb 2014 11:59:00 +0530 There is growing evidence that the current healthcare systems of countries would become unsustainable if they continue to function as they do currently. While healthcare is primarily organized within national geographies, the issues involved are truly global. Increasing demand, rising costs, changing demographics, new technologies and consumer expectations are creating significant challenges and opportunities. Therefore, now India's premier industry bodies and top global consulting firms will collectively draw up strategies for the future with a view to provide recommendations to address the crucial healthcare challenges of the nation and countries beyond faced with similar concerns. The conglomeration of industry leaders will work together under a unique initiative, "The Healthcare Alliance" - an entity envisioned by Dr Prathap C Reddy, chairman, Apollo Hospitals Group, in a mission to accelerate the journey for a healthier future. The conglomeration will invigorate collaborative thinking, collective expertise and experience to lay the foundation for tomorrow's healthcare which would need to be collaborative, connected, accessible and smart. The announcement was made at a press briefing organized by the alliance. The Healthcare Alliance includes five leading industry bodies - All India Management Association (AIMA), Confederation of Indian Industry (CII), Federation of Indian Chambers of Commerce and Industry (FICCI), Indian Medical Association (IMA) and Healthcare Federation of India (NATHEALTH); four knowledge partners of global eminence - Bain & Company, KPMG, McKinsey & Company, and PwC; research and policy think tank Public Health Foundation of India (PHFI) as the "technical resources group"; and Apollo Hospitals as the coordinating partner. The driving force behind the initiative, Dr Prathap C Reddy, chair of The Healthcare Alliance, remeraked, "It is for the first time that such an august and unique set of Industry Bodies and Knowledge Partners are joining hands to facilitate deliberations on globally relevant themes in healthcare amongst various key constituents. The coming together of such experienced organisations reaffirms the belief that much can be achieved collectively to better the healthcare scenario in India and create solutions that would impact the situation in the country and be replicated elsewhere in the world." The Healthcare Alliance announced its inaugural two-day global conference to be held in New Delhi on 3rd& 4th March 2014 - The Future of Healthcare: A Collective Vision. The conference will be graced by the presence of several luminaries from the healthcare sector both from India and abroad and bring together among others, Health Ministers and Health Secretaries of several nations, policy makers, thought leaders as well as business and health leaders from across the globe. Prof K Srinath Reddy, President, Public Health Foundation of India, added, "Public health requires a collective societal response in order to realise the dream of universal healthcare for one and all. Given PHFI's role of an independent public health think tank and mandate of working with all stakeholders to strengthen public health capacity and capability, we look forward to contributing our knowledge and technical expertise to this initiative and furthering our commitment to the nation's health and well being." Health is not just a shared responsibility involving equitable access to essential care; it is also the human face of the science of healing, responsible for billions of lives and intrinsically needs to be inclusive. This ethos and the rising burden of disease in India and across the world demand that stakeholders come together and find solutions that are innovative, systemic, sustainable, impactful for a country like India and replicable especially in the African nations, neighbouring ASEAN countries and elsewhere across the world. Luminaries participating in the two-day event include: Dr. Victor Dzau, Lord Nigel Crisp, Mr. John Brooks, Mr. Amir Rubin, Mr. John Adler, Mr. Euan Thompson, Mr. Krishna Udayakumar, Dr. Rajiv Doshi, among others. Participating speakers will focus on four crucial areas covered in four sessions, namely Control of NCDs through Primary and Preventive Healthcare;Public Private People Partnership; Talent Fast Forward: Upskill, Upscale Innovation for Universal Access. The final and the fifth session titled "Future Perfect: My Vision", will witness thought leaders share their vision on the future of healthcare and present their recommendations for immediate actions. Speaking about the conference, Dr Prathap C Reddy said, "Good health is a fundamental human right. Yet, the world is facing unprecedented healthcare challenges today which demand breakthrough innovation and sustainable and practical solutions across the entire spectrum, from affordable patient care, diagnostics and treatment methodologies to financing, infrastructure, manpower and social policies. This unique conference would put the best minds in healthcare under one roof to drive radical innovation in the industry to change the global healthcare landscape for the better." Over the last three months, members of the alliance have worked closely to identify key areas of concerns and have reached out globally to thought leaders to collaborate and arrive at global solutions that are systemic, sustainable and impactful. Findings from these discussions and deliberations are being compiled into four white papers - one each on the specific areas of the conference; each paper looking into a definitive way forward and an action plan to impact the future of healthcare in the 21st century. The white papers will be released at the conference. The solutions arising from this conference would not only favorably impact health in India, but also serve as a unique model for addressing health challenges globally; i.e. the notion of reverse innovation in healthcare out of India. ]]> <![CDATA[Cipla to Co-market MSD's raltegravir tablet, for Indian Market]]> https://biospectrumindia.com/news/95/6577/cipla-to-co-market-msds-raltegravir-tablet-for-indian-market.html https://biospectrumindia.com/news/95/6577/cipla-to-co-market-msds-raltegravir-tablet-for-indian-market.html Fri, 21 Feb 2014 11:17:50 +0530 In a major development, MSD, one of the world's key players in HIV innovative treatment and pharmaceutical giant Cipla - preeminently known for its leading position globally in ensuring treatment for all HIV/AIDS patients, announced the formation of an India-specific strategic partnership. Within the scope of the partnership, Cipla will have a non-exclusive license to market, promote and distribute MSD's raltegravir 400mg tablet, under a different brand name in India. Access to raltegravir is important for patients who require it as part of third line salvage regimen where there are few options left. Announcing the partnership, Mr KG Ananthakrishnan, managing director, MSD in India said, "MSD is committed to developing innovative therapies that offer advances in the treatment of infectious diseases - including HIV. MSD's efforts to develop treatments for HIV/AIDS have been under way for more than 20 years and continue today. We are proud to have entered into a strategic, India-specific partnership with Cipla. MSD and Cipla both share the same commitment of providing broader access to HIV treatment." Commenting on the partnership, Dr Jaideep Gogtay, chief medical officer, Cipla said,"This partnership reinforces Cipla's ongoing commitment to HIV/AIDS treatment making life-saving drugs accessible. Raltegravir, a third line therapy treatment will be a value addition to Cipla's portfolio of HIV/AIDS treatment, especially for those patients who are resistant to the 1st and 2nd line therapy treatment. We anticipate this drug being available to patients from middle of this year." Furthermore, Mr Subhanu Saxena, managing director and global CEO, Cipla added, "We want to ensure that all patients, particularly in developing countries, get access to the most innovative, breakthrough medicines available. We look forward to more such collaborations ensuring lifesaving drugs like raltegravir reach the patients in need." ]]> <![CDATA[Generics dominate Indian pharma]]> https://biospectrumindia.com/news/95/3554/generics-dominate-indian-pharma.html https://biospectrumindia.com/news/95/3554/generics-dominate-indian-pharma.html Fri, 21 Feb 2014 10:24:00 +0530 The total sales turnover of Indian Pharmaceuticals products, which are largely generics, was about Rs 1,20,000 crore in the year 2012-13. This was stated by the minister for chemicals & fertilizers, Srikant Kumar Jena in a written reply in the Parliament on February 18, 2014. He mentioned that the Indian pharmaceutical market is mostly of generic medicines and at the same time the patented medicines have no generic versions. The minister said that a Price Negotiation mechanisms Committee was set up for patented drugs. "The Committee's report was put on the public domain for wider publicity for inviting comments from stakeholders, Observing the diverse opinion of different stakeholders received by the Government, an Inter-ministerial Committee of Joint Secretaries to look into the issues and to suggest ways and means to fix the prices of patented drugs in the country has been formed, remarked Mr Jena. ]]> <![CDATA[Karnataka to host National Biofuel conference]]> https://biospectrumindia.com/news/95/1215/karnataka-to-host-national-biofuel-conference.html https://biospectrumindia.com/news/95/1215/karnataka-to-host-national-biofuel-conference.html Wed, 19 Feb 2014 17:30:03 +0530 The Karnataka State Biofuel Development Board has announced that the national conference on Biofuels will be held in Bangalore on February 22 this year. The board stressed that the event will focus on 'Accelerating Biofuel programs in India'. The day-long conference being held at Hotel Capitol in Bangalore will focus on generating winning ideas from the pioneers in the industry to eventually look at some intervention and suggestions to bring about changes in the national biofuel policy. Speaking about the need for the intervention, Mr A K Monnappa, managing director, Karnataka State Bio Fuel Development Board, quoted facts. He said, "India imports over 80 percent of its petroleum needs spending a whopping Rs Eight lakh crore a year ($128,640 million), which is the single-most critical component of the import bill of the nation. This is not only exerting a lot of financial stress but also leading us towards an energy crisis. In spite of such imports, rural India suffers energy shortages which is adversely affecting agri-operations and quality of life, resulting in avoidable migration to urban areas." He further said, "It is estimated that India has the potential to substitute at least 30 percent of these imports through biofuels which could make a huge difference to our foreign exchange situation and to rural prosperity. If we could do miracles in food and milk production, we can definitely report the success in biofuels too." Adding, "This conference will be inaugurated by Dr Satish B Agnihotri, secretary, MNRE. He would also be chairing the concluding session of the conference. Through the conference we aim to address some of the major concerns of the value chain of the biofuel development program. Our counterparts from Tamil Nadu, Andhra Pradesh, Chhattisgarh, Bihar, Madhya Pradesh, and Maharashtra amongst others would present their success stories. The reviews of various stakeholders would be heard."He said, the executive chairman of the board, Mr GVK Rau, ACS and development commissioner and Mr Vijay Bhaskar, ACS, department of rural development and Panchayat Raj of Government of Karnataka will also be present at the event. Further, Mr Monnappa explained that the concluding panel discussion would present the crux of the program. "The panel discussion will revolve around suggestions for new initiatives and policy changes that are required on the national level. The novel initiatives that would help the country scale up on the global level will be summed up." Claiming that every policy worth its salt should be valued once in 4-5 years, Mr Divakar Rao, Vision Group on Biotechnology, Government of Karnataka said that if this is not done, policies remain merely on paper. "There is a need to take a second look at the policy. New components need to be added. We are looking at certain replicable models. Karnataka's board strives to take forward the biofuel movement in the state with a farmer-centric, multi-species approach which is supported by a well thought out infrastructure designed to support all stages of the value chain of biofuels," he said. Further explaining, "In the meeting of the reconstituted MNRE Working Group on biofuels held in New Delhi in January 2014, it was aptly decided that a national conference could be an excellent platform to deliberate on these points, and come out with ideas on new initiatives and policy changes required. Karnataka was chosen to plan and host the conference." The conference will put together the experiences of different states in the biofuel sector. An evaluation of the progress achieved and problems faced by some of the prominent states will be discussed. Further, a discussion on achieving critical volumes in Biomass production would be held. An important aspect that is relevant in achieving the desired volumes and quality in biofuel production in a viable and sustainable manner would be discussed in the 'Managing biofuel value chain' part of the conference. The event is being co-sponsored by the Hutti Gold Mines and Novozymes South Asia and will be attended by farmers, rural entrepreneurs, industrialists, businessmen, investors, policy makers, strategists, representatives from several states, members of the working group of MNRE, representatives from all I&D Centres of the Board, major NGOs and members of KSBDB. The event will also witness the presence of Dr Navin Sharma, a representative from ICRAF from the World Agro-forestry Centre. The UN body is said to have noted that the path-breaking work done in Karnataka may be best suited to the needs of several developing nations of Asia and Africa. ]]> <![CDATA[Minister: There is provision in the Seed Act for GM QC ]]> https://biospectrumindia.com/news/95/5483/minister-there-is-provision-in-the-seed-act-for-gm-qc-.html https://biospectrumindia.com/news/95/5483/minister-there-is-provision-in-the-seed-act-for-gm-qc-.html Wed, 19 Feb 2014 16:22:00 +0530 The Seeds Act, 1966, Seed Rules, 1968 and the Seeds (Control) Order, 1983 adequately cover the quality control of seeds including GM seeds. The Seeds Act, 1966 and the Seeds (Control) Order, 1983 have provisions to draw the samples of GM seeds and test the same in the seed testing laboratories notified under section four of the Seeds Act, 1966. The protocol for determining the presence or absence of genes in GM seed have been prescribed under Rule 33 of the Seed Rules, 1968 and laboratories for testing are notified under it. Only Bt. Cotton has been allowed by Genetic Engineering Appraisal Committee (GEAC) in India. The cost of Bt. Cotton seed is fixed by the respective State Government in consultation with Bt. Cotton seeds producing companies. This information was given today by Minister of State for Agriculture and Food Processing Industries, Tariq Anwar in a written reply to Lok Sabha questions. ]]> <![CDATA[Often neglected, rare diseases now have a collective voice]]> https://biospectrumindia.com/news/95/4549/often-neglected-rare-diseases-now-have-a-collective-voice.html https://biospectrumindia.com/news/95/4549/often-neglected-rare-diseases-now-have-a-collective-voice.html Wed, 19 Feb 2014 11:29:00 +0530 India is home to an estimated over seventy million patients affected with one of more than seven thousand rare diseases. The number of patients with known and novel rare diseases is increasing every year and it is estimated that 1 in 20 Indians are affected by one of the seven thousand rare diseases. Due to the inadequate infrastructure or the lack of awareness at various stakeholder levels, rare disease management is growing into a major healthcare concern in India. There is much to be done at the policy level to address the needs of rare disease patients. The absence of budget allocation for research is a major bottleneck in developing a quality healthcare delivery mechanism for rare disease patients in India. Since there are seven thousand types of rare diseases and each of these diseases affects a very small population there are severe constraints in conducting scientific and clinical research and development of a nationwide newborn screening regimen. This has lead to limited therapeutic and diagnostic modalities for rare disease patients. Although there have been individual organizations and persons working in the area but the need for a strong collective voice was important for pursuing pending issues with the government.Therefore to address that, the Organization for Rare Diseases India (ORDI) was formally launched by the founding team members in a function held at the constitution club of India on February 18, 2014. The launch ceremony was attended by eminent scientific and medical advisors of ORDI, representatives of the rare disease stakeholders and key opinion leaders in health care policy and adminstration in India. ORDI's vision is to make rare diseases in India diagnosable and treatable just like other common diseases such as diabetes, breast cancer and cardiovascular disease etc. ORDI's mission is to be the collective voice of every rare disease patient, family member, and healthcare professionals in India by pooling together expertise, efforts, and resources to help early diagnosis, treatment and management of rare diseases in India. Commenting on the launch, Dr Vijay Chandru, founder member ORDI said, "There is a genetic origin for at least 80 % of rare diseases and in 50 % of cases the onset occurs in childhood. Rare diseases also include rare cancers, autoimmune diseases, congenital malformations and infectious diseases among others. A majority of these diseases lack proper diagnosis and treatment options. Through ORDI we will try to empower rare disease patients and their families in India with access to national and international resources and help improve their quality of life. This would also mean the development and delivery of affordable diagnostics and treatments for rare diseases through innovative collaborations and partnerships among multiple stakeholders." ORDI will open doors for patients to access facilities and opportunities by registering with patient advocacy groups within India and overseas, such as Jain Foundation for diagnostic testing, patient registries and clinical trials. Jain foundation is a patient advocacy group focused on Limb Girdle Muscular Dystrophy 2B and is heavily involved in creating opportunities in India for clinical trial readiness. Establishing patient registries, and systematic treatment protocols to finding a cure for rare diseases is the ultimate goal of these joint efforts," said Dr. Madhuri Hegde, founder member ORDI. "Patients suffer physically, mentally and financially as the families knock on the doors of various hospitals seeking diagnosis. Even after proper diagnosis, there is little hope for cure. It is in this context ORDI has an important role to play in pooling together expertise, efforts, and resources to help patients and health professionals share information on rare diseases across India," said Prasanna Shirol, founder member ORDI and former President of Lysosomal Storage Disorders Support Society. "The whole education and healthcare system is more geared to cater to common diseases such as infectious diseases, diabetes, cardio vascular disease and cancer. This lack of awareness has created a dearth of resources and clinical care for patients with rare diseases," said Sangeeta Barde founder member ORDI. "Information technology (IT) has emerged as a greatest enabler of recent times. ORDI is determined to leverage IT in serving rare disease cause by being an umbrella organization for information contribution, collection, consumption and propagation on rare diseases. ORDI also serves as a platform that unites, educates and connects rare disease patients, doctors, scientists, volunteers, evangelists and organizations with the help of latest technological breakthroughs." Ravinandan ME, founder member ORDI quoted. "Rapid advances in applying molecular diagnostics tools such as next generation sequencing and bioinformatics to diagnose patients worldwide across the human disease spectrum will have a highly beneficial impact in the diagnosis, treatment and management of rare disease patients. ORDI sees exciting real opportunities emerging out of the molecular diagnostics revolution in enabling personalized medicine for rare disease patients in India", said Dr. Preveen Ramamoorthy, founder member ORDI. "Our review of the state of rare disease management in India identified the various challenges and opportunities in India (currently under review by a peer-reviewed journal). The need for an umbrella organization to engage all rare disease stakeholders in India became evident. ORDI serves as this common platform to initiate open engagement among and strengthen the unified voice of rare disease stakeholders in India." continued Dr. Harsha Karur Rajasimha, founder member ORDI "We are very encouraged by the enthusiasm and support of several national and international rare disease organizations for our mission. Rare Genomics Institute (RGI) represents one of our early partners in USA. RGI is helping to facilitate crowd funding for genomic-based research to help undiagnosed and economically disadvantaged patients with rare disease in India. Several Indian disease-specific patient advocacy organizations and biotech industry bodies have confirmed their collaboration with ORDI." - he concluded. ]]> <![CDATA[Global medtech firm DJO ventures into India ]]> https://biospectrumindia.com/news/95/5695/global-medtech-firm-djo-ventures-into-india-.html https://biospectrumindia.com/news/95/5695/global-medtech-firm-djo-ventures-into-india-.html Wed, 19 Feb 2014 07:05:00 +0530 DJO Global International, one of the world's largest orthopaedic companies, has ventured into India. The firm's product range includes a wide variety of non-surgical orthopeadic products for rehabilitation, pain management and physical therapy for treatment of arthritis DJO Global International, one of the world's largest orthopaedic companies, has ventured into India. The firm's product range includes a wide variety of non-surgical orthopeadic products for rehabilitation, pain management and physical therapy for treatment of arthritis DJO Global International, one of the world's largest orthopaedic companies, has ventured into India. The firm's product range includes a wide variety of non-surgical orthopeadic products for rehabilitation, pain management and physical therapy for treatment of arthritis. Five-of-the-10 products have already been launched by the company and it plans to launch the remaining five products over a period of one year. DJO Global's products address several concerns associated with patient care, including injury prevention, rehabilitation after surgery, injury or from degenerative disease, enabling people to regain or maintain their natural motion. The company's products are used by a large number of healthcare practitioners such as orthopedic specialists, spine surgeons, primary care physicians, pain management specialists, physical therapists, podiatrists, chiropractors, athletic trainers and other healthcare professionals. Furthermore, several of the company's medical devices and related accessories are used by athletes and patients for injury prevention and at-home physical therapy treatment. DJO product lines include rigid and soft orthopedic bracing, hot and cold therapy, bone growth stimulators, vascular therapy systems and compression garments, therapeutic shoes and inserts, electrical stimulators used for pain management and physical therapy products. The company's products are marketed under several brands including, Aircast, Chattanooga, CMF, Compex, DonJoy, Empi, ProCare, DJO Surgical, Dr Comfort, Bell-Horn and Exos. ]]> <![CDATA[Suven secures two product patents for their NCEs]]> https://biospectrumindia.com/news/95/3616/suven-secures-two-product-patents-for-their-nces.html https://biospectrumindia.com/news/95/3616/suven-secures-two-product-patents-for-their-nces.html Tue, 18 Feb 2014 16:31:43 +0530 Suven Life Sciences announces that the grant of two product patents from New Zealand (600536 &601242) corresponding to the New Chemical Entities (NCEs) for the treatment of disorders associated with Neurodegenerative diseases. These Patents are valid through 2029 and 2030 respectively. The granted claims of the patents include the class of selective 5-HT compounds discovered by Suven and are being developed as therapeutic agents and are useful in the treatment of cognitive impairment associated with neurodegenerative disorders like Alzheimer's disease, Attention deficient hyperactivity disorder (ADHD), Huntington's disease, Parkinson and Schizophrenia. With these new patents, Suven has a total of 19 granted patents from New Zealand. These granted patents are exclusive intellectual property of Suven and are achieved through the internal discovery research efforts. Products out of these inventions may be out-licensed at various phases of clinical development like at Phase-I or Phase-II. "We are very pleased by the grant of these patents to Suven for our pipeline of molecules in CNS arena that are being developed for cognitive disorders with high unmet medical need with huge market potential globally" says Mr Venkat Jasti, CEO of Suven. The company has 12 internally-discovered therapeutic drug candidates currently in pre-clinical stage of development targeting conditions such as ADHD, dementia, depression, Huntington's disease, Parkinson's disease and obesity in addition to developmental candidate SUVN-502 for Alzheimer's disease and Schizophrenia. ]]> <![CDATA[Feb 28 to be deciding date for Biocon, Mylan]]> https://biospectrumindia.com/news/95/3615/feb-28-to-be-deciding-date-for-biocon-mylan.html https://biospectrumindia.com/news/95/3615/feb-28-to-be-deciding-date-for-biocon-mylan.html Tue, 18 Feb 2014 15:50:40 +0530 Indian Biotechnology major Biocon and US generic drug maker Mylan, who have been selling their jointly developed biosimilar version of Roche's breast cancer drug, have now challenged the interim order. Both companies that released their biosimilar version of breast cancer drug Trastuzumab, have challenged the Delhi High Court's interim order that barred them from using Swiss drug innovator Roche's data to sell their biosimilar. Meanwhile, the court last week said that it was not taking an immediate position on whether the two firms had the drug regulator's approval for the package insert they were using to sell their biosimilar version of Trastuzumab. The order further read, "At present, there are two versions of the parties which are contrary to each other." In its argument, Roche pointed out that the claims made by Biocon and Mylan in their package insert are a "slavish copy" of the innovator's version. It further explained that it goes much beyond, and is even contrary to, what the drug regulator had originally approved. Biocon and Mylan on the other hand have insisted that the package insert was duly approved by the drug authority. They argued, "Unless the main approval or the approval for package insert is revoked or cancelled, we are entitled to use the same in their packaging while marketing the drug." ]]> <![CDATA[Genesis Burson-Marsteller, Medulla to strengthen pharma and healthcare offering]]> https://biospectrumindia.com/news/95/3863/genesis-burson-marsteller-medulla-to-strengthen-pharma-and-healthcare-offering.html https://biospectrumindia.com/news/95/3863/genesis-burson-marsteller-medulla-to-strengthen-pharma-and-healthcare-offering.html Tue, 18 Feb 2014 15:03:53 +0530 Genesis Burson-Marsteller, leader in integrated communications announced its strategic partnership with Medulla Communications, a specialized healthcare communications agency, aiming to provide integrated strategic, creative and medical communication solutions for the Health and Wellness sector. Mumbai-based Medulla will now exclusively partner with Genesis Burson-Marsteller to service health and wellness communication requirements. With these changing dynamics of the healthcare landscape, it has become increasingly complex for companies to navigate the regulatory, technology, media, competition, consumer, retail and influencers (healthcare professional) communication requirements. Healthcare companies now need a single window service to address their strategic, marketing and communication concerns across all media and target audiences. The two consultancies now have the combined ability to offer a unique blend of service lines that provide an evidence-based idea driven approach across all communication platforms - traditional, social media, broadcast, etc. with reach extending from major Metro cities to Tier II and III markets. The comprehensive suite of offerings includes brand strategy and communication, medical strategy and advisory, key opinion leader (KOL)relationships, physician and influencer engagement, consumer and patient education and support, corporate reputation management, CSR, public affairs and digital marketing - all designed to support the clients' business objectives.Speaking on the partnership, Mrs Prema Sagar, principal & founder of Genesis Burson-Marsteller said, "Given the immense potential in the health and wellness market, we are excited to be working with such an innovative team of healthcare communication experts. Our combined experience allows us to understand the ever evolving and specialized needs of this sector and help clients adapt and innovate. Together, we will be a force multiplier for our existing and potential clients." Commenting on the development, Mr Praful Akali, founder and managing director, Medulla Communications said, "Corporate reputation, corporate social responsibility and public policy influence are nowhere of more significance than in the health and wellness segments - the immense experience that Genesis Burson-Marsteller brings in these areas will certainly help our clients. Moreover, this partnership allows us to bring in an integrated communications offering and scale that clients in this sector may not have experienced before." This alliance will bring to clients the ability to leverage an in-house team of doctors, certified medical writers, medical strategists and medico-marketing experts. Medulla's unique tie-ups with International associations like American Association of Continuing Medical Education (AACME) and American Gastroenterology Association (AGA), where they helped develop customized content for India, will also open up new avenues for clients. ]]> <![CDATA[Nine states eager to set up biotech parks]]> https://biospectrumindia.com/news/95/5258/nine-states-eager-to-set-up-biotech-parks.html https://biospectrumindia.com/news/95/5258/nine-states-eager-to-set-up-biotech-parks.html Tue, 18 Feb 2014 11:45:00 +0530 The project proposals that have been received recently by the union government for consideration and setting up of biotech parks are from the states of Madhya Pradesh (Chhindwara), Jammu and Kashmir (Jammu and Srinagar), Gujarat (Gandhinagar), West Bengal (Kolkota) and Chattisgarh. These proposals have been examined and the coordinators have been appointed. This information was provided by the union minister of science and technology and earth sciences, S Jaipal Reddy in the parliament recently. "The several state governments/central institutes have submitted proposals for setting up parks in states like Assam, Karnataka, Kerala, Odisha, Madhya Pradesh, Jammu & Kashmir, West Bengal, Gujarat and Chattisgarh," said Mr Reddy. The minister mentioned the details of the biotechnology parks aided by department of biotechnology (DBT) currently functioning in the country. Among that is the Uttar Pradesh based Lucknow BT Park that has been established at Lucknow with support from DBT and started operations from 2006. The park has generated employment for about 200 persons. To date 7-8 companies have graduated from the incubator and another 9 companies are in incubation. The Park has NABL accreditation for its analytical facilities and provides service to many agro-industries in the region. The plant tissue culture facility is also certified under DBT-BCIL certification program. They have an extraction unit, a bioinformatics unit and a bio-fuel unit. The park is also hosting HRD programs for research scholars and a Biotech finishing school. Apart from that Andhra Pradesh has Hyderabad BT Park established by council for Scientific and Industrial Research-Indian Institute of Chemical Technology (CSIR-IICT) and government of Andhra Pradesh with support from DBT and started operations from 2009.World class facilities have been created for use by entrepreneurs on use and pay basis. There are 12 labs of 350 sq. ft each which is given out to incubate companies. Business centre approach is used in this Park and 9 companies, 74 scientists are working there. In Tamilnadu, is TICEL Bio Park (Chennai)set up by the state government, operational since Nov, 2004. DBT had sanctioned grant for establishing a Biotechnology Core Instrumentation Facility (BTCIF). It has now achieved 100% occupancy with National and International clients. The tenancy area has 74 modules of 1525 sq.ft. each, available for clients to develop their own customized R&D labs of BSL2 standards, upgradeable to BSL3, in accordance with GLP standards. Tamil Nadu also has the Golden Jubilee Biotech Park for Women (Siruseri, Kanchipuram District) established with support from DBT and is operational since 2001. The Park has a Lab facility for providing Quality testing and Training programs as a means of providing hands-on experience and to generate revenue streams for the Park.It is an Entrepreneurial facility for women Scientists aided with managerial skills and capable of making small-scale investment, to independently take up the functioning of the lab. At present the park is fully occupied. 80% comprises of 1st generation entrepreneurs. All entrepreneurs are women. In all there are 150 workers which includes 50-60% of women both skilled/unskilled.The total annual turnover is Rs 5 crore. The details of parks proposed to be set up in near future state wise is as follows: i. Assam: Guwahati Biotech ParkGoA has recently allotted a land measuring 17 acres to Guwahati Biotech Park. Facilities include 8 Modular Laboratories, Specialized & Support Facilities.Interim facilities have been created at IIT Guwahati in a building rented out to the State Govt for the Park/Incubator. ii. Karnataka: Bangalore Biotech ParkThe Park is under construction with25 Incubation suites ranging from 200 sft to 700 sft. Also has plan for Common Instrumentation facility, Mammalian and Plant tissue culture, Dark room/Cold room/Utilities, Animal house/Chemical store, Cafetaria/Meeting rooms/Conference rooms etc. iii. Kerala: KINFRA Biotech ParkThey are providing infrastructure for industries to incubate. They have labs with commercial facilities. 6 units are under construction. 20 acres land is available for lease to industries. The building has been completed. iv. Odisha: Bio Pharma-IT Park, Andharua, BhubaneswarThe facility is developed in Bhubaneswar on a land parcel of 64.61 Acres. The Park area has been demarcated and walled off and utilities have been provided. The construction of building for the incubator is yet to begin.Focus on Training Program & GMP quality facility. ]]> <![CDATA[Delhi High Court dismisses injunction by Life Tech Corp]]> https://biospectrumindia.com/news/95/3635/delhi-high-court-dismisses-injunction-by-life-tech-corp.html https://biospectrumindia.com/news/95/3635/delhi-high-court-dismisses-injunction-by-life-tech-corp.html Mon, 17 Feb 2014 18:17:00 +0530 ]]> <![CDATA[Too little too late says ABLE on union budget 2014-15]]> https://biospectrumindia.com/news/95/5860/too-little-too-late-says-able-on-union-budget-2014-15.html https://biospectrumindia.com/news/95/5860/too-little-too-late-says-able-on-union-budget-2014-15.html Mon, 17 Feb 2014 18:08:00 +0530 In his reaction on the interim budget, Dr PM Murali, president, Association of Biotech Led Enterprises (ABLE) mentioned,"The vote on account of the finance minister is more of a maintenance budget wherein he has tried his best to make up for lost grounds. The captains of the biotech industry have long been saying that Manufacturing is the key for ushering in fresh growth impetus to the Industry. It appears that the finance minister has realized this after serious dips in the financial figures in this sector." Dr Murali on behalf of industry expressed optimism over the government proposal to create a fund. "The idea of creating tax relief in the creation of a research fund is welcome. We need more money into this sector and any such initiative is welcome. Education is a key sector for providing valuable human capital to this industry. The focus on educational loans is again a welcome sign. However, healso expressed his disappointment on lack of focus on agriculture. "Agriculture is a big sector and ABLE is a bit disappointed that there was nothing of cognizance here," said Dr Murali. ]]> <![CDATA[GM Crops need no regulations much like conventional farming: Montagu]]> https://biospectrumindia.com/news/95/7964/gm-crops-need-no-regulations-much-like-conventional-farming-montagu.html https://biospectrumindia.com/news/95/7964/gm-crops-need-no-regulations-much-like-conventional-farming-montagu.html Mon, 17 Feb 2014 18:07:00 +0530 "Genetically Modified (GM) crops need no regulations as conventional farming and to feed 1.2 billion people in India biotechnology cannot be ignored, Prof Marc Van Montagu, Founder & Chairman, Institute for Plant Biotechnology Outreach, Ghent University, Belgium said last week at Delhi. Delivering the keynote address at inaugural session of the Krishi 21- Conference on Sustainable Greener Agriculture- at National Bureau for Plant Genetic Resources (NBPGR) here Montagu said, "India needs GM crops and if we do not need regulations for conventional farming, I do not think these GM varieties need any regulations. Nature is a big genetic laboratory and we should accept it." The two-day Krishi 21 Conference on "Agricultural Transformation toward Greener Economy" organized by Green Agri Miles saw several prominent scientists deliberating about green agriculture and economy. Prof RB Singh, Chancellor, Central Agriculture University and Chairman of the Conference briefed about the theme. "Private sector is serving humanity in a big way. We should have a Public Private Partnership (PPP) for biotechnology. Science is not liberated in India to serve society," he said. "The country needs to enhance productivity by 40% to meet the growing need of food and green agriculture has to be nitrogen, water and energy smart, "Singh added. Prof Montagu emphasized that scientists need to understand the need of society and they will have to step out from their laboratories to convince people about the wonders science and especially biotechnology can bring in agriculture. Prof Montagu has founded the Institute of Plant Biotechnology Outreach (IPBO) with the mission to assist developing countries in gaining access to the latest plant biotechnology developments and to stimulate their research institutions to become independent and competitive. "The new innovations can transform agriculture to meet the requirements of food and feed of the world. Enormous future awaits agriculture and with best of science including molecular biology, target of feeding 1.2 billion in India would not be an unachievable task," Montagu added. The World Food Prize laureate highlighted the various sustainable solutions for the pressing food security problems of the future. To meet this, we should embrace a realistic approach that seeks to answer what science can do and what society wants, he added. "We need a realistic approach towards GMOs (GM crops and GM food) as well. We need to tell society about benefits and safeguards. It would be wrong to believe that scientists are not concerned about agro-ecology and biodiversity. Therefore, I firmly believe that sustainable intensification is the way out for future," Montagu pointed out. Prof HS Gupta, Director IARI said, "India has achieved great success in food sufficiency both with the help of GM and non-GM crops. We now need to diversify in other sectors like horticulture and animal feed. Food diversification can help the country both in production and management of crops."Mr Prabhakar Rao, CMD, NSL emphasized on scaling up the best agronomy practices to meet future requirements and to give boost to these practices across the country, adequate policy support would be required. Mr Ajay Vir Jhakar, Chairman, Bharat Krishak Samaj said that regulating big business in India is a major challenge. "We need technology for greener economy. We are not allowing our scientists to do more research in biotechnology. China spends Rs 13,000 on biotech research and India hardly spends Rs 100 crore. Thus we are ignoring scientific knowledge which can revolutionize our agriculture," he said. The experts deliberated on subjects such as "Greening Agriculture toward Green Economy," "Technologies, Innovations and inputs for Sustainable Development" during the two separate session on the first day of the Conference. Besides scientists, senior officials of public and private sector also participated in the discussion. ]]> <![CDATA[Budget 2014-15 proposes creation of new research funding organization]]> https://biospectrumindia.com/news/95/3622/budget-2014-15-proposes-creation-of-new-research-funding-organization.html https://biospectrumindia.com/news/95/3622/budget-2014-15-proposes-creation-of-new-research-funding-organization.html Mon, 17 Feb 2014 17:21:00 +0530 While maintaining that his government has passionately espoused the cause of science, the finance minister, Mr P Chidambaram mentioned that the promotion of scientific research, supported scientific applications and inventions, has been on top priority. "Now, a 'Research Funding Organisation' is to be set up to fund research projects selected through a competitive process." This was proposed by the finance minister, P Chidambaram while presenting Interim Budget 2014-15 in Parliament on February 17, 2014. He said that contributions to that organisation will be eligible for tax benefits. This will require legislative changes which can be introduced at the time of the regular Budget. He also mentioned that the agriculture GDP growth increased to 4% during UPA II. In the current year it is estimated at 4.6 percent. "We are proud of the stellar production of the agriculture section," he remarked. The ministry of health and family welfare saw an increase in its allocation with it getting Rs 33,725 crore to spend for the next one year. ]]> <![CDATA[Kolkata to host World Congress on Public Health ]]> https://biospectrumindia.com/news/95/3626/kolkata-to-host-world-congress-on-public-health-.html https://biospectrumindia.com/news/95/3626/kolkata-to-host-world-congress-on-public-health-.html Mon, 17 Feb 2014 16:58:00 +0530 The 14th World Congress on Public Health (WCPH) "Healthy People - Healthy Environment"will be held from February 11-to-15, 2015 in Kolkata, India. Making this announcement at a curtain raiser held here in New Delhi, Mr J Chauvin, president, WFPHA, and co-chair, 14th WCPH - International Core Organizing Committee, said, "The World Congress on Public Health is a unique opportunity for the global public health community to come together to learn from each other and to adopt new, more effective ways to help people improve and protect their health. The World Federation of Public Health Associations (WFPHA) is delighted to be associated with the Indian Public Health Association (IPHA) in hosting this important event." "Health is everyone's business. Where we live, where we work, where we play are all important factors that affect our health. The World Congress on Public Health, is a unique opportunity for frontline health workers and decision makers to come together to discuss and learn how we, in partnership with people around the world, can contribute to achieve Health for All", Mr Chauvin added. Mr Chauvin further said, "The theme of the 14th World Congress on Public Health is very timely and pertinent. 'Healthy People - Healthy Environment' provides a forum wherein public health professionals from around the world will explore how environments, be they the built environment, the political and legal environment, the socio-cultural environment, the economic and financial environment, our ecosystem environment and the infrastructures society has created, including our healthcare systems, affect the health and well-being of people, whatever their life circumstances. This will be an exciting event, identifying ways and means to help communities and countries respond to the challenges to achieving Health for All." The 2015 Congress will offer unique opportunities to discuss global, and national public health issues among the global public health community and other key stakeholders. It will provide a unique opportunity to help catalyse change, bringing together and bridging perspectives from various disciplines of public health to inï¬‚uence governments, organizations, agencies and institutions around the world to meet the challenge of improving people's health. The 14th World Congress on Public Health will be hosted jointly by the World Federation of Public Health Associations (WFPHA) and the Indian Public Health Association (IPHA). In keeping with the tradition, youth participation will be a key element of the Kolkata Congress. Participants of the congresses include delegates from public health associations of the world, as well as representatives from the public and private sectors, representatives from public health related sectors and NGOs based in member states of the World Federation of Public Health Associations. The World Congress, will provide a unique opportunity to share experiences, exchange knowledge about effective policies, programs and best practices for public health. The Congress will also provide a platform to debate and discuss prevailing and emerging global health issues. The key themes of the plenary sessions will be: Stream 1: Defining the role of Public Health in today's global settingStream 2: Public Health in the Sustainable Development AgendaStream 3: Public Health Approaches to address new challenges ofsustainable development & healthy environmentStream 4: Global Public Health ChallengesStream 5: Human Rights and Law as tools for Sustainable Development Dr. Madhumita Dobe, Organising Secretary 14th WPCH 2015 said on this occasion, "Twelve congresses have taken place so far and the opportunity comes to India after a long hiatus of more than 30 years, during which the global public health scenario has changed with a lot of exciting initiatives. The 14th World Congress on Public Health with its theme of 'Healthy People-Healthy Environment'- is expected to provide opportunities to the global public health community to get together and deliberate on important issues. It will also serve as a platform to showcase India's efforts and for sharing knowledge and experiences of public health professionals from over the world. There will be sharing of experiences, knowledge exchanges, debate, discussion and learning about effective policies, programs and best practices in support of the public's health." Dr. Mengistu Asnake, WFPHA Vice President/President Elect and Co-Chair of Scientific Committee said, "As public health professionals and members of WFPHA, we all have an individual and collective responsibility in making our values a reality - saving lives and contributing to better health and wellbeing for all wherever they may be!" ]]> <![CDATA[Pune virology institute develops high-potential papaya ]]> https://biospectrumindia.com/news/95/3629/pune-virology-institute-develops-high-potential-papaya-.html https://biospectrumindia.com/news/95/3629/pune-virology-institute-develops-high-potential-papaya-.html Mon, 17 Feb 2014 10:39:00 +0530 The regional office of the IARI, which is a part of Indian Council for Agricultural Research (ICAR) system, has done significant work in the control of plant viruses and has developed virus resistant varieties of many fruits and vegetables. It has also developed production strategies for managing virus diseases in a large number of crops. Virus diseases lead to large-scale losses in many important horticultural crops such as papaya, citrus fruits, capsicum, tomato and cucurbits. Agriculture Minister, Mr Sharad Pawar, on February 16, inaugurated the new building of the institute. On this occasion, Mr Pawar expressed the hope that the new infrastructure being set up would help the institute to utilize the most modern technology in control of plant diseases. This new facility would also help state agricultural universities and sister institutes of the ICAR in Maharashtra, he said. Mr Pawar informed that this institute started way back in 1938 as the first research centre on plant virology and has done pioneering research in the control of plant viruses. The Department of Biotechnology has recognized it as an 'accredited test laboratory, under its National Certification System. The institute's Pune Selection -III papaya variety gives an average yield of 40 tonnes per hectare even under high disease pressure. It recently signed memorandum of understanding (MoU) with a biotech company for production of virus-free tissue culture raised banana seedlings. This, Mr Pawar expects, will ensure high returns to farmers. ]]> <![CDATA[Nuclear medicine a developing field in India ]]> https://biospectrumindia.com/interviews/95/6065/nuclear-medicine-a-developing-field-in-india-.html https://biospectrumindia.com/interviews/95/6065/nuclear-medicine-a-developing-field-in-india-.html Fri, 14 Feb 2014 16:34:00 +0530 With the evolving techology molecualr imaging to provide speedy, reliable and accurate results and will also help reduce cost associated with ineffective therapies. Keeping all these aspects in mind Mr KN Sudhir, business head - Molecular Imaging, Siemens Healthcare, India, puts some light on the molecular technological advances. 1. Tell us about Siemens' Biograph mCT Flow & Symbia Intevo? Mr Sudhir: The Biograph mCT Flow PETâ€¢CT system with FlowMotion Siemens found a way to overcome the limitations of conventional PET/CT. So far, PET exams were done in sequential segments, called bed positions. With Biograph mCT Flow's FlowMotion technology, the patient bed moves continuously inside the gantry and allows anatomy-based planning. That means each exam is planned based on that specific patient's anatomy, so physicians can plan their exams to get more information where it is really important for that patient. The Symbia Intevo xSPECT system now, the world's first xSPECT system, with this physicians have the potential to not only image disease, but also leverage the high resolution to see the unseen and more confidently interpret images. Moreover, Symbia Intevo's unique quantitative capabilities may provide the ability to monitor and adjust treatments earlier by accurately measuring even small differences. xSPECT hardware and software technology enables higher image contrast, and more precise lesion characterization provides physicians additional support in distinguishing between degenerative disease and cancer. This facilitates physician decision making and potentially minimizes the need for costly CT, MR or biopsy follow-ups. To supplement this outstanding improvement in image quality. xSPECT reconstruction is also the world's first quantitative technology. 2. Can you briefly explain the R&D in nuclear medicine space vis-Ã vis-Siemens. Collaboration between our customers and our research partners is thecornerstone for new developments. We are working closely with our customers as they are doing new procedures and research, to understand how we can better adapt our systems and our technologies to support their needs, as well as helping them understand what we can do. 3. How these products are going to be helpful to patients and what are their clinical uses?Molecular imaging unmasks the biochemical processes that underlie disease before structural abnormalities appear, serving as a compass to guide physicians as they seek to find, characterize and follow disease, adjusting the course as needed to ensure their patients stay on the quickest path towards health. The Biograph mCT Flow PETâ€¢CT system with FlowMotion technologyovercomes the limitations of stop-and-go imaging, providing one continuous scan that enables examination parameters, such as speed, image resolution and motion management, to be easily adjusted to the dimensions of individual organs. The Symbia Intevo xSPECT system overcomes the challenges of conventional, mechanically fused SPECT/CT technology, by completely integrating SPECT and CT data during image reconstruction. The resulting accurate alignment facilitates extraction of medically relevant information from CT data for improved image resolution for bone imaging and quantitative measurements. Now physicians can not only image disease, but also leverage the high resolution to see the unseen and more confidently interpret images. 4. How is the approach towards nuclear medicine in India as compared toother countries? Nuclear medicine is a developing field in India as compared to the western countries. We feel there are more milestones to cover. Most patients in India pay from their pockets to cover the healthcare expenses, so the cost of the procedure is a major concern here. This yet restricts some of the major clinical uses of this modality. For example, use of PET/CT for Alzheimer's detection and use of PET and SPECT for cardiac studies has yet to see its true potential in India. Also awareness of this field is limited to metropolitan areas and tier 1 cities. Most of the smaller towns and cities in India still do not have this type of facility and, as a result, little awareness about the availability of molecular imaging and its value to the patient care continuum. ]]> <![CDATA[Biotech industry under one roof : BIB 2014]]> https://biospectrumindia.com/news/95/5105/biotech-industry-under-one-roof-bib-2014.html https://biospectrumindia.com/news/95/5105/biotech-industry-under-one-roof-bib-2014.html Fri, 14 Feb 2014 15:57:00 +0530 Bangalore: The pioneers from the Biotechnology industry gathered at the Bangalore India Bio 2014, as if with a renewed hope, to strike a chord with those who matter in the industry globally.The event that was inaugurated by the Chief Minister of the State of Karnataka, Mr Siddaramaiah witnessed the presence of over 20 foreign delegations, alongside emerging and established companies, in the field of Biotechnology. Inviting the audiences that numbered in hundreds, the Ministry of Information Technology, Biotechnology and Science and Technology launched India's first ever biotech and medtech incubator. The Karnataka government arranged for a 3D movie, giving a 360 degree view of the incubator that would be launched within the next two years. Organized by the Department of Information Technology, Biotechnology and Science & Technology, Government of Karnataka and the Vision Group on Biotechnology, the three day event will end on February 12, 2014.Listing out 12 winning reasons why Bangalore has become synonymous with Biotechechnology, Mr Srivatsa Krishna, secretary, Department of IT, Biotechnology and S&T DPAR (e-governance), Government of Karnataka even described the planned incubator in detail. Dr Kiran Mazumdar-Shaw, chairperson of the Karnataka Vision group on Biotechnology and CMD of Biocon said in the inaugural speech that the Karnataka government is playing a pivotal role in shaping the biotech industry in the state. "India has such a life science model that can be easily emulated across the world. The Karnataka government with its futuristic policies that brings together the industry, academia and the government has helped the state receive global recognition. Considering that we not only have to feed our increasing young population, but also have to take care of our soon ageing population - technology is going to play a key role," Dr Kiran said at the inauguration. She said that the government should look at investing more in Science and technology to help address the increasing challenges of global health. Dr Kiran also emphasized that the government would play a major role in shaping the biotech destiny of the country and will help place the industry on the global platform. The Chief Minister Mr Siddaramaiah said that the Bangalore India Bio 2014, partnered by MM Activ Sci-Tech Communications has helped increase the awareness and participation in the industry. "The presence of such large number of foreign delegates at this event is proof of what Karnataka is doing in the field of Biotechnology," said Mr S R Patil, Minister for Information Technology, Biotechnology and Science and Technology and Planning & Statistics, Government of Karnataka.Meanwhile, lauding the efforts of the state in increasing biotech related activities, Nobel Laureate 2012, Professor Sir John Gurdon, Distinguished Group Leader, The Wellcome Trust/Cancer Research UK, The Gurdon Institute, University of Cambridge, UK appreciated the efforts of all involved. ]]> <![CDATA['We are not a risk-loving country']]> https://biospectrumindia.com/news/95/3637/we-are-not-a-risk-loving-country.html https://biospectrumindia.com/news/95/3637/we-are-not-a-risk-loving-country.html Fri, 14 Feb 2014 11:16:19 +0530 Mr Shrikumar Suryanarayan, co-founder, C-CAMP and Chairman, Sea6 Energy, in his opening presentation on mentoring said, "It is one of the big experiments in the area of entrepreneurship. It is about what we need to make to ensure our country produces while translating ideas in to enterprises. We are not a risk-loving country. We need to encourage people to take risks." "While we can throw money at problems, that alone is not enough. Having all the money and great facilities cannot replace mentorship," he further added. Talking about the role of mentors, Mr Suryanarayan expressed, "Many of us were not aware of our own potential at some point. The idea is that, initially even a seed needs to be given certain amount of sunlight, water and expert care and that is why we are here. At times we get discouraged because we do not meet the right people who see the potential in us." According to Mr Suryanarayan, mentoring recognizes and nurtures potential. He opined, "There are different ways to slice and dice your ideas, and one is looking at the strategic business and technical, transformational and personal, and organizational potential. The approach is that it should allow you to occupy unique space and help you to pursue what you love and make you self-sufficient. We are in a technology game and there are tricks. It is all about learning from your experience." Commenting about the financial challenges encountered by entrepreneurs, Mr Suryanarayan added, "Your finances are going to run out. You know your experiments are not going to work at times. How do you bounce back then? In the entrepreneurial journey, you cannot do it all by yourself. You need to carry your team. The reason is, it is the journey that is a reward, and not the destination. It is about making sure that we are equipped to enjoy this journey." Dr Suryanarayan also stated that the only way to keep entrepreneurial minds excited is by enrolling the whole team. "Make sure you enroll your team early enough to build leadership. It takes five years to build a leader and they have to be there all throughout the journey. Pick your people carefully and enroll them in to the same vision and enjoy the journey with them," he concluded. Another speaker, Dr K K Narayanan, MD, Metahelix Life Sciences, spoke on commercialization of scientific ideas and technology based on his experience gained while building Metahelix. He said, "The secret of commercializing your scientific ideas is essentially going to be in your hands. I was an academician at Madras University, but I wanted to do something on my own. For an agrarian country like India, I thought, large sections of people were engaged in agriculture. Our main needs are food, feed and energy. I was fortunate to work in labs and gain skills and confidence, and then Metahelix came on the scene, backed by financial assistance from Nadathur Group. It is important to get the right partner and sufficient resources." On the lines of learnt lessons from the past, he added, "Be flexible as long as it is ethical, and be prepared for failures. In this country, people do not want to fail. However, in this journey, you have to fall in order to rise and succeed. But you never actually fail, unless you have given up." "You may fall down, but you have to dust your knees, get up and run again. Recovering from failures is the key to success," he said. Talking about having alternative plans, Dr Narayanan opined, "When you are obsessed to make a product out of a scientific idea, and if it doesn't work, you should not get emotionally attached to it to the point where you don't realize it is not working. So there should always be an alternative plan." On entrepreneurial financial owes, Dr Narayanan believes that one has to careful in choosing the right financial partners. "You may or have people who will be willing to fund your idea. But many of them really don't understand the details of technological developments and more importantly, financial risks. Now, there are always financial and technological risks. At every stage there are risks of failures. You should have a clear wavelength with the investors," he said. "I have known many enterprises, if had given enough time, they would have succeeded, but were killed because of the unreasonable expectations from the financial partners. It is very important to believe in yourself. That is the key," he opined. Talking about the challenges in innovations, Dr Narayanan pointed out the following: Limiting infrastructure, uncertain regulatory environment, quality human resource and weak public-private interface. He concluded by saying, "You cannot afford to keep looking at the negatives, crib about it and move forward. You have to see the positive side as well. You have to take many people along with you because you are the leader of the enterprise. There is no giving up." The following experts were identified as mentors and invited for the mentorship program who interacted with the mentees: Dr Anand Anandkumar, Cellworks; Dr Anindya Sircar, Infosys; Mr Animesh Agarwal, VenturEast; Dr Aswin Sai Narain Seshasayee, NCBS; Dr Atul Aslekar, VLife Sciences; Mr Chandrasekhar Nair, Bigtec; Dr S Ganesh, Anthem Biosciences; Dr K K Narayanan, Metahelix; Prof S Ramaswamy, C-CAMP; inStem; Prof G Sabarinathan, IIM-B, NSRCEL (TBC); Dr Shirshendu Mukherjee, Wellcome Trust; Mr Shrikumar Suryanarayan, Sea6 Energy; Prof Smita Lele, ICT; Dr Swami Manohar, founder & managing director, LimberLink Technologies; Dr Swami Subramaniam, Abbott Nutrition; Dr Taslimarif Saiyed, C-CAMP. The program also saw presentations by BIG entrepreneurs. ]]> <![CDATA[Padma Shri winners felicitated by Asian Institute of Oncology]]> https://biospectrumindia.com/news/95/7826/padma-shri-winners-felicitated-by-asian-institute-of-oncology.html https://biospectrumindia.com/news/95/7826/padma-shri-winners-felicitated-by-asian-institute-of-oncology.html Thu, 13 Feb 2014 15:28:00 +0530 On the occasion of republic day on 26th Jan, 2014, Mumbai's three eminent doctors were honored with Padma Shri for their exemplary contribution in the field of their expertise. Following this Dr Milind Kirtane, Dr Raman Deshpande and Dr Shashank Joshi were felicitated at Asian Institute of Oncology for receiving the prestigious award. Dr Deshpande is a well-known Oncosurgeon in India and also the executive vice chairman of Asian Institute of Oncology is among the three doctors who will be recognized for their efforts and work in their respective field. He trained at the world renowned Memorial Sloan Kettering Cancer Centre and worked in Tata Memorial Hospital for 17 years. Apart from writing several medical research articles and books on cancer, Dr Deshpande was also the first person to introduce thoracoscopic surgery at the Tata Memorial Hospital. Dr Milind Kirtane, ENT Surgeon, has been practicing at the privately-run Hinduja Hospital, Mahim, for four decades. During his long career, he has treated about 1,600 children who had a hearing disability. "My work is concentrated around conducting cochlear implants for the deaf. Since 1995, our team has trained doctors from across India, including public hospitals like KEM, Sion and Nair, to conduct such implants," said Dr Kirtane. "This could help many of the 2-3 million people in the country who are deaf. About 90% of them are children." he added. Endocrinologist Dr Shashank Joshi practices at Lilavati hospital and has done tremendous amount of work in research and clinical care in endocrinology. On being felicitated by Asian Institute of Oncology, Dr Joshi said, "Currently, There are 65 million diabetics in India. Today, we are next only to China in the number of people with diabetes. I have been advocating the prevention of diabetes through eating less, eating right, walking more, sleeping well and smiling more. We are designing guidelines for physicians to treat diabetes, rather than following foreign models," ]]> <![CDATA[Cipla appoints Dr Peter Mugyenyi as the new Independent director]]> https://biospectrumindia.com/news/95/5569/cipla-appoints-dr-peter-mugyenyi-as-the-new-independent-director.html https://biospectrumindia.com/news/95/5569/cipla-appoints-dr-peter-mugyenyi-as-the-new-independent-director.html Thu, 13 Feb 2014 14:58:00 +0530 Cipla announce the appointment of Dr Peter Mugyenyi as an independent director on the Board with immediate effect. Dr Mugyenyi is the director and co-founder of the Joint Clinical Research Centre (JCRC) based in Kampala. He is highly regarded across the globe for his dynamic leadership in helping Africa battle its mounting AIDS epidemic. A pediatrician by training, Dr Peter Mugyenyi is recognized as one of the worlds' foremost specialists and researchers in the field of HIV/AIDS. Dr Peter Mugyenyi said, "I am proud to be part of Cipla's contribution to humanity and would like to emphasize that innovation in the crucial area of human survival should not be entirely dependent on revenue generation. It should primarily aim at alleviating the human suffering and saving lives. This does not contradict fair trade, because business success and humanism are not incompatible." Announcing the appointment, Dr Y K Hamied, chairman, Cipla said,"It is a privilege for Cipla to have Dr Mugyenyi as a member of Cipla's board of directors. His presence would be most influential in the heart of the highest governing body of Cipla. I believe that as a world leader, Dr Mugyenyi will be a source of inspiration for us, someone who can also guide us in our journey towards our vision of 'None shall be denied'." Dr Peter Mugyenyi is also the author of Genocide by Denial: How Profiteering from HIV/AIDS Killed Millions. Published in 2008, a book that details the story of how Western Governments and drug companies callously oversaw the death of millions of Africans who were unable to afford their branded drugs. A follow-up of this book was published in 2013. Dr Mugyenyi played a major consultative role in the formulation of the PEPFAR (President's Emergency Plan for AIDS relief) program, which was announced in the 2003 State of the Union address by President George W Bush. PEPFAR has since put millions of Africans on lifesaving anti-retroviral treatment. ]]> <![CDATA[Health minister trashes reports about adverse impact of pentavalent vaccines ]]> https://biospectrumindia.com/news/95/6157/health-minister-trashes-reports-about-adverse-impact-of-pentavalent-vaccines-.html https://biospectrumindia.com/news/95/6157/health-minister-trashes-reports-about-adverse-impact-of-pentavalent-vaccines-.html Wed, 12 Feb 2014 10:20:00 +0530 The health minister Mr Ghulam Nabi Azad has rejected the reprts that had blamed the pentavalent vaccines as a cause behind the rise in the reported Adverse Events Following Immunization (AEFI) cases all over the country including 8 states (Tamil Nadu, Kerala, Goa, Jammu & Kashmir, Haryana, Gujarat, Karnataka and Puducherry) where pentavalent vaccine has been introduced in phased manner. The health minister has mentioned that the increase in reporting is not found to be associated with Pentavalent vaccine use. "This increase in reported AEFI has been due to strengthening of AEFI monitoring, revision of AEFI guidelines in 2010, dissemination of guidelines, constitution of District & State AEFI committees and regular review of AEFI cases by National AEFI committee. An AEFI secretariat has also been established to strengthen the AEFI monitoring in the country," said Mr Azad. Pentavalent vaccine is a licensed vaccine. Any drugs including vaccines are licensed and cleared by Drug Controller General of India after examining the safety and efficacy profile of the product. The health minister stated further, "The Government shall continue to use Pentavalent vaccine as eleven more states ie Andhra Pradesh, Assam, Bihar, Chhattisgarh, Jharkhand, Madhya Pradesh, Punjab, Rajasthan, West Bengal, Delhi and Uttarakhand has requested for introduction of Pentavalent vaccine in their state after successful introduction of Pentavalent vaccine in 8 states." ]]> <![CDATA[Scientists called upon to lead at BIB 2014]]> https://biospectrumindia.com/news/95/3504/scientists-called-upon-to-lead-at-bib-2014.html https://biospectrumindia.com/news/95/3504/scientists-called-upon-to-lead-at-bib-2014.html Tue, 11 Feb 2014 17:48:07 +0530 Bangalore: In the next 50 years, innovation will be driven from the East. Karnataka's Biotech industry accounts for a third of the revenues of the Biotech sector which is currently worth $7.5 billion in the country and has huge potential. With these thoughts reverberating through day one of the 14th edition of the Bangalore India Bio 2014, the second day of the three day event had many thoughts being spelt out in various sessions spanning through the day. The day opened with the plenary and keynote lecture by the World Food Prize Laureate 2013, Professor Dr Marc Van Montagu, also founder and chairman of the Institute of Plant Biotechnology Outreach (IPBO), Belgium. Dr Montagu emphasized on how we are running out of raw materials like petroleum and that new materials are already in labs. "Biotechnology will play an important role in creating new raw materials that will help the chemical industry," he said. He key message that he stressed upon was that the 21st century plants will be with GMOs. Dr Montagu said that the argument against GM crops is mixed up with many things, including emotional issues. Addressing the productivity challenge, he said, "We require plants to deliver stable production and for this we need to return to the fields." Science, he opined is an opportunity to drive home solutions. The World Food Prize Laureate 2013 called upon the scientists' community to lead the industry. He said, "Scientists have to mobilize and will have to lead the way. They will have to do sustainable intensification." Further emphasis was laid on how many not-for-profit organizations are in an attempt to seek power, spreading mis-interpreted data. This, he said is extremely unwise. The enormously growing population in India has posed a challenge. "This challenge can be met by governance, which will need science and engineering to turn the challenges into economic opportunities." He also added that adoption of technology takes time and hence we need to be more patient. Meanwhile, the wide panel also raised concerns regarding the turbulent clinical trial weather in the country. The secretary of the Department of Biotechnology, Mr K Vijay Raghavan said that regulations need to be relaxed for the smooth conduct of clinical trials. "Activists say clinical trials cannot be done unless regulations are met. But one can't say that trials cannot be done unless all extreme views are satisfied, which is a very dangerous position. The result of that would be, those who are rich would buy all the drugs and others would suffer," he explained. Mr S R Patil, Karnataka IT Minister too raised concerns regarding clinical trial restrictions. "You can understand our limitations on the issue because it is an international issue. Also in India, there are legal and ethical dimensions in it. I see an urgent need for consensus among industry, NGOs, government and judiciary," he said. ]]> <![CDATA[Affordability doesn't make Indian drugs spurious says Azad ]]> https://biospectrumindia.com/news/95/3576/affordability-doesnt-make-indian-drugs-spurious-says-azad-.html https://biospectrumindia.com/news/95/3576/affordability-doesnt-make-indian-drugs-spurious-says-azad-.html Tue, 11 Feb 2014 13:44:00 +0530 The union health minister for health and family welfare, Mr Ghulam Nabi Azad has stated that India exports medicines to about 210 countries and vaccines to about 150 countries in the world. These medicines while being affordable are as effective as drugs manufactured in the developing countries, he mentioned. The health minister further said that being affordable should not mean that they are 'cheap and spurious'. "Efficacy of the Indian drugs should not be judged on the basis of their cost as the input cost in India is much less than that in the developing countries due to the less expensive human resources. The developing countries such as India who have a growing pharma industry should be allowed to grow," said Mr Azad who spoke at the agreement signing event between USFDA and health ministry at New Delhi on February 10, 2014. The minister highlighted that India has taken several measures to strengthen the regulatory mechanisms in terms of capacity building, strengthening laboratories and bringing enhanced transparency through its laws and legislations. Azad also stated that stringent punishment up to life imprisonment is prescribed for those involved in manufacturing or selling of spurious drugs. Special courts have been set up for speedy trails of those involved in such crimes. "Moreover, 16 out of 28 states in country have special courts for speedy trials. The Indian government has also framed rules for compensation due to death in clinical trials", he said. ]]> <![CDATA[Government to Launch Fourth Phase of the NACP-IV ]]> https://biospectrumindia.com/news/95/5696/government-to-launch-fourth-phase-of-the-nacp-iv-.html https://biospectrumindia.com/news/95/5696/government-to-launch-fourth-phase-of-the-nacp-iv-.html Tue, 11 Feb 2014 13:18:07 +0530 The union minister for health, Mr Ghulam Nabi Azad will launch fourth phase of the National AIDS Control Program (NACP-IV) of the Department of AIDS Control (DAC) on 12th February, 2014 to accelerate the country's AIDS program. The NACP-IV has been designed based on the lessons learnt from previous phases. The strategic plan for NACP-IV for the period 2012-17 has been developed through an elaborate multi-stakeholder consultative planning process. Consolidating the gains made till now, the NACP-IV aims to accelerate the process of epidemic reversal and further strengthen the epidemic response in India through a cautious and well defined integration process over the five-year period. The objectives of NACP-IV are to reduce new infections and provide comprehensive care and support to all PLHIV and treatment services for all those who require it. A number of new initiatives have been planned under NACP-IV. The national program will continue to innovate and generate lessons from its performance management system and disseminate the best practices across the globe. The total budgetary allocation for the fourth phase of the National AIDS Control Program (NACP-IV) for five years is Rs 14,295.05 crores. The project will be partly funded through grants from the Global Fund and credit from the World Bank. India has demonstrated an overall reduction of 57% in the annual new HIV infections (among adult population) from 2.74 lakhs in 2000 to 1.16 lakhs in 2011, reflecting the impact of various interventions and scaled-up prevention strategies under the NACP. The adult HIV prevalence has decreased from 0.41% in 2001 to 0.27% in 2011. Besides, the estimated number of people living with HIV (PLHIV) has decreased from 24.1 lakhs in 2000 to 20.9 lakhs in 2011. Wider access to Antiretroviral therapy (ART) has resulted in a 29% reduction in estimated annual deaths due to AIDS related causes between 2007 and 2011. It is estimated that around 1.5 lakh lives have been saved due to ART till 2011. India is committed to achieve the Millennium Development Goals (MDG) in reducing HIV mortality. The country is making a significant progress in achieving this goal by its focused efforts through the National AIDS Control Program (NACP). In 1992, the Government launched NACP-I and NACP-II was initiated in 1998. Based on the learning from NACP-I and II, the Government designed and implemented NACP-III (2007-2012) with an objective to "halt and reverse the HIV epidemic in India" by the end of the project. The NACP-III has given the desired results. India's AIDS control efforts have been appreciated in the UN General Assembly Special Session as one of the global success stories. ]]> <![CDATA[SCHOTT KAISHA completes five years in the industry]]> https://biospectrumindia.com/news/95/3588/schott-kaisha-completes-five-years-in-the-industry.html https://biospectrumindia.com/news/95/3588/schott-kaisha-completes-five-years-in-the-industry.html Tue, 11 Feb 2014 12:58:57 +0530 SCHOTT KAISHA, India's leading pharma packaging company, has completed half a decade of successful partnership. Building on its success, the company inaugurated India's first fully automated pharmaceutical packaging plant in February 2013 in Jambusar, Gujarat. This Greenfield facility, set up with an initial investment of 20 million Euros (136 crores INR), helped SCHOTT KAISHA to increase its production capacity by almost 50 percent to around 2.4 billion pieces per year. With the first module nearing its full capacity by January 2014, the company is looking to further expand the production facility and hire over a 100 people, bringing the total figure to more than 1700. The facility is housed in an area of 20 acres with ample room to construct additional production modules in parallel with the increasing demand of customers. "We are happy to have met highest demands of quality and supply with maximum customer satisfaction. We remain committed to help our customers achieve their own growth and quality objectives in India as well as abroad." says Mr Kairus Dadachanji, managing director of SCHOTT KAISHA. In the last five years, SCHOTT KAISHA has been awarded ISO 9001, ISO 14000-18000 and ISO 15378 certificates. In addition, SCHOTT KAISHA has successfully set up an independent tool room with highly specialized Computer Numerical Machines (CNC) that enable a even more precise dimensional control. "Due to our strong focus on quality, based on SCHOTT's more than one hundred years of experience, we retain state of the art equipment and a highly skilled workforce dedicated to quality control and inspection. Maintaining consistent global standards in all our facilities worldwide helps us to offer tailor-made products and services for growing international pharmaceutical markets such as India," says Dr JÃ¼rgen Sackhoff, executive vice president of SCHOTT Pharmaceutical Systems. ]]> <![CDATA[Bangalore is synonymous with Biotech: BIB 2014]]> https://biospectrumindia.com/news/95/6953/bangalore-is-synonymous-with-biotech-bib-2014.html https://biospectrumindia.com/news/95/6953/bangalore-is-synonymous-with-biotech-bib-2014.html Tue, 11 Feb 2014 12:19:00 +0530 Bangalore: The pioneers from the Biotechnology industry gathered at the Bangalore India Bio 2014, as if with a renewed hope, to strike a chord with those who matter in the industry globally. The event that was inaugurated by the Chief Minister of the State of Karnataka, Mr Siddaramaiah witnessed the presence of over 20 foreign delegations, alongside emerging and established companies, in the field of Biotechnology. Inviting the audiences that numbered in hundreds, the Ministry of Information Technology, Biotechnology and Science and Technology launched India's first ever biotech and medtech incubator. The Karnataka government arranged for a 3D movie, giving a 360 degree view of the incubator that would be launched within the next two years. Organized by the Department of Information Technology, Biotechnology and Science & Technology, Government of Karnataka and the Vision Group on Biotechnology, the three day event will end on February 12, 2014. Listing out 12 winning reasons why Bangalore has become synonymous with Biotechechnology, Mr Srivatsa Krishna, secretary, Department of IT, Biotechnology and S&T DPAR (e-governance), Government of Karnataka even described the planned incubator in detail. Dr Kiran Mazumdar-Shaw, chairperson of the Karnataka Vision group on Biotechnology and CMD of Biocon said in the inaugural speech that the Karnataka government is playing a pivotal role in shaping the biotech industry in the state. "India has such a life science model that can be easily emulated across the world. The Karnataka government with its futuristic policies that brings together the industry, academia and the government has helped the state receive global recognition. Considering that we not only have to feed our increasing young population, but also have to take care of our soon ageing population - technology is going to play a key role," Dr Kiran said at the inauguration. She said that the government should look at investing more in Science and technology to help address the increasing challenges of global health. Dr Kiran also emphasized that the government would play a major role in shaping the biotech destiny of the country and will help place the industry on the global platform. The Chief Minister Mr Siddaramaiah said that the Bangalore India Bio 2014, partnered by MM Activ Sci-Tech Communications has helped increase the awareness and participation in the industry. "The presence of such large number of foreign delegates at this event is proof of what Karnataka is doing in the field of Biotechnology," said Mr S R Patil, Minister for Information Technology, Biotechnology and Science and Technology and Planning & Statistics, Government of Karnataka.Meanwhile, lauding the efforts of the state in increasing biotech related activities, Nobel Laureate 2012, Professor Sir John Gurdon, Distinguished Group Leader, The Wellcome Trust/Cancer Research UK, The Gurdon Institute, University of Cambridge, UK appreciated the efforts of all involved. ]]> <![CDATA[Policymaking and bioscience: The missing link]]> https://biospectrumindia.com/news/95/4285/policymaking-and-bioscience-the-missing-link.html https://biospectrumindia.com/news/95/4285/policymaking-and-bioscience-the-missing-link.html Mon, 10 Feb 2014 11:36:00 +0530 The policymaking on scientific research in India is driven by many factors including focus on national priority areas such as health, energy, power, information technology among others. The government while investing money in the respective areas, looks at tangible solutions for the issues that the nation is facing. In particular, the drafting of long term policy especially in bioscience, usually depends on the involvement of prominent scientists and administrators in a committee. While most of the time, decisions are taken at the higher level, there are times when the consultations are held with general public over the issues that directly affect them. However, the opinions of grass root level researchers from private sector and public institutes, might have not found place in the traditional approach. The most commonly cited reasons include the communication gap and reluctance to convey the fair opinion. Dr Dharamchand Jain, general manager - Green Tech, IPCA Labs, is of the opinion that the gap ultimately leads to the loss of country's knowledge treasure. "Scientists work in different environment and sometimes do not understand the requirement of drug development and conversion into commercial production. Similarly the gap between both agencies is still too much less trust each other therefore not achieved required results," says Dr Jain. Pointing towards the contradiction between science and policymaking, Dr T Jacob John, retired professor of clinical virology, Christian Medical College, Vellore mentions particularly about the lack of consistency, "What was the policy for AIDS control? Was it to create a modality for control? (started as AIDS Task Force in 1986, fully autonomous and financed by the government of India, converted to National Aids Control Organization (NACO) in 1992, with heavy financial input from World Bank, but using all Task Force strategy and tactics) or was it to actually control? (goal set for reversing the trend of increasing burden by 2010?) or was it to make private sector work with public sector as equal partners? (CMC Vellore that established a project to explore if HIV had reached India, sent someone for training to US, obtained test reagents and detected the very first infected people in Chennai Remand Home, and designed all the elements of control interventions is in the private sector, and was designated national reference lab by GoI from 1986 onwards). Dr John adds further, "When it came to polio, giving 3 doses for primary immunisation was the rule (was it policy?) but when science found that 3 was grossly inadequate and proposed 5 doses in first year, or pulse method to rapidly control polio, or to use IPV -- all in the early 1980, none of these was accepted -- here policy was in direct contradiction to science and until that gap was filled in the mid-2000s, we could not eliminate polio. Policy makers do not keep abreast of science." Democratising bioscience policy or it isn't realistic at all? Can the policy made from the board rooms without even consulting those who would get affected by it? One of the key aspects of shift in the bioscience policy from traditional approach to a more inclusive one, is to make it more democratic by finding ways to involve researchers at the grassroots level. Dr P M Murali, CEO, Evolva Biotech mentioned, "I think this is a given. All the brains in India should come together to frame policies and facilitate the growth of this sector. I am not sure this can be left to any specific group. Also these days public opinion is also important and hence informed debate is also necessary. There is a transition on the way things are done today. People's involvement is critical and supreme." Completely agreeing with it, Dr Villoo Morawala Patell, MD and chairman, Avesthagen too feels that it is highly required. "Yes there is a large gap between the scientists and the policy making mechanism. There needs to be a democratic inclusion in policy making. Also different stakeholders need to be brought in from the start," she says. A prominent researcher in an Indian MNC told BioSpectrum on the basis of anonymity that there certainly is a gap that needs to be bridged urgently. "Opinion of the scientists in industry need to be a part of the policy making process - scientists in academic institutes and universities themselves constitute the different committees in the policy making bodies making it a closed club - it is a "buddy-approving-buddy's-project" situation where the favour is returned when the roles are reversed in another committee. I have noticed that the industry people are looked upon with suspicion, disdain and mock appreciation (condescension is probably a better word)," he said. Policy rejig at regular intervals It is interesting to note that China has increased their biomedical research funding by 30 percent, India has increased it by 10 percent. China reduced TB burden to less than half of India, in the last 20 years when back then we were more or less on par. "In general, policy making concerning health has not been satisfactory. There is some confusion between policy and programme goals/targets. Our National Health Policy was made in 2002 and has not been revised since then. Therefore, each section under health management seems to be setting its own policy for moving forward. I am guessing that each has its own policy, says Dr Jacob John. One researcher with decades of experience in industry says, "The policy framework of the country only by academicians is sometimes unrealistic, as what industries need for the competition to international market. It always benefits when the policy must by joint collaboration." Few scientists believe that the PPP is not only for research but also for policy implementation. "But in India the private sector is not regulated or audited by the government. The regulating/auditing functions are part of the mandate of a public health department; we do not have one in India," mentioned a prominent academician and scientist. Dr P M Murali proposes a fresh approach. He says, "We need to form several regional think tanks in science and technology, independent of institutional bias. This should comprise of individuals from industry, academics and Social groups. The stake holders need to have a larger say in their requirements. We should also co opt the best brains from outside the country to bring in fresh international thinking. This body should be able to recommend to the planning commission and the concerned ministries. We have to be sure that this does not become one more body among the many." However, sometimes there are highly exceptional cases where the policy is overtaken by the sheer passion of researchers. Nothing better explained than the words of Dr K VijayRaghavan, secretary, DBT who spoke on the topic 'investments in bioscience' at the University of Hyderabad, "Hidden inside such successes is a larger issue. Can India combine science, technology and translation to scale? Can we innovate to do extraordinary science with meager resources? Can we design affordable solutions to our problems? The rotavirus vaccine saga provides a partial answer. Was there was a 'top-down' planning to work on the indigenous rotavirus vaccine? Not really. The vaccine came about through passion, chance, grit... the details of which have been outlined elsewhere." ]]> <![CDATA[ICMR boosts funding for biotherapeutic drugs]]> https://biospectrumindia.com/news/95/4419/icmr-boosts-funding-for-biotherapeutic-drugs.html https://biospectrumindia.com/news/95/4419/icmr-boosts-funding-for-biotherapeutic-drugs.html Mon, 10 Feb 2014 11:30:00 +0530 According to Indian Council of Medical Research (ICMR), there is no centralized database or registry existing to obtain data on clinical research on therapeutic drugs. But, ICMR is promoting research in the area of bioinformatics and genomics as per details given below since the year 2010 till date:- The grant released for bioinformatics project is Rs 315.31 lakh including the adhoc projects costing Rs 211.86 lakh and fellowship projects Rs 154.56 lakh. The genomics project, the grant released is Centre for Advance Research at Rs 610.38 lakh including adhoc projects at Rs 240.79 lakh. The fellowship projects were upto the tune of 52 lakhs. The information was provided by Mr Ghulam Nabi Azad, Union Minister for Health and Family Welfare in a written reply to the Lok Sabha on February 08, 2014. ]]> <![CDATA[Mute to Biotech Agenda!]]> https://biospectrumindia.com/features/95/7976/mute-to-biotech-agenda.html https://biospectrumindia.com/features/95/7976/mute-to-biotech-agenda.html Mon, 10 Feb 2014 10:30:00 +0530 With elections round the corner, all the political parties have geared up for campaigns and electioneering to woo their voters. However, apart from the popular and ideological issues, the focus on science is limited and health or life sciences is even far too negligible. The reason most apparently is that it may not fetch enough votes on ground. Blame it on the lack of awareness on such issues or the absence of a strong voice, the other issues have overshadowed the importance. We tried to contact political parties for their comments and learnt the hard way that science is not as important as other issues. Busy with drafting their respective manifestos, the party bigwigs chose not to answer our calls, mails and even tweets. However, finally we managed to speak to lower rung leaders in few key parties. Closer look at the political parties manifesto in 2009 and we come to know that the health, energy and agriculture are very important to them but not the means. There is a contradiction in how the policies they adopt will then be able to fulfil the promises they made. Till now no party has released its party manifesto 2014 officially as their respective election committees are working on the final drafts. A Delhi based political analyst told BioSpectrum that though the times have changed for good but the ways of electioneering continue to be the same. The issues such as this will take much longer time. A closer look at the party manifestos also confirms that as well. Dr P M Murali, president Association of Biotechnology Led Enterprises (ABLE) too agrees with the analysis. He says, "I think people understand health. There is always something in their manifesto. But lot do not understand research that goes into this sector. So I would say that this is more ignorance than indifference." "If IT (information technology) is India today then BT (biotechnology) is bharat tomorrow," was the famous quote from the former prime minister and Bharatiya Janta Party (BJP) leader, Atal Bihari Vajpayee. In its 2009 manifesto, the party talks about leveraging technologies such as information technology, biotechnology Quoting the same, "Indian advancements in astronomy, mathematics, chemistry, physics and biological sciences have been documented and recognised all over the world. Contributions in the field of medicine and surgery are also well known. Ayurveda and Yoga are the best gifts from India to the world in creating a healthy civilisation. There will be special emphasis on developing renewal energy sources, especially solar energy, wind energy and run-on-the-river technology, and bio-fuel." A BJP spokesperson mentioned that the party feels that no genetically modified seed must be allowed for cultivation without full scientific data on long-term effects on soil, production and biological impact on consumers. The Congress party representative handed over its 2009 manifesto that talks more on the health schemes such as the National Rural Health Mission to improve the quality and accessibility of primary health care. There is requirement for increased funding in healthcare and agriculture. Apart from that the preservation of bio-resources to ensure their sustainable use and promotion of agricultural technologies. Many politicians from the party who have supported the BRAI bill include former science and technology minister, Mr Prithvi Raj Chavan. Also, Mr Manish Tewari, former spokesperson, ruling party, had told BioSpectrum, "Let the scientific matters be decided by the scientists and not get caught in the administrative and political non-decisiveness." Aam Aadmi Party (AAP) representative mentioned that their convener Arvind Kejriwal in past has made said his party was opposed to genetically modified crops and his colleague Prashant Bhushan had filed a PIL in the Supreme Court against it. "The aam aadmi is unaware of GM crops and the Biotechnology Regulatory Authority of India (BRAI). People don't understand it. Regulation spells corruption and our party is striving to change the political system that breeds corruption." The party might take the help of Dr Kiran Mazumdar-Shaw, chairperson, Biocon, to draft its policy for the sector. The left parties recognize the biotechnology as a potential but want it to be monopoly free. Besides their opposition to GM seems to be more ideologically driven against US MNCs. The Communist Party of India (Marxist) in its agenda talks about raising public expenditure on health to 5% of GDP. It talks about enhancing public funding of indigenous research in science and technology to promote self-reliance; decentralization in funding for R&D; fundamental research in the sciences to be accorded priority. However, the CPI's National Council member Dinesh Vasnik has made it clear that they would fight on these issues inside and outside Parliament. He warned against foreign aids and grants for agriculture research, seminars and such programmes that were meant to promote the agenda of multi-national companies. CPI(M) leader Sitaram Yechury too has shown his opposition on lot many forums. "We do not need a bio-regulatory bill. We need a bio-safety law," he had remarked at a protest rally held against the bill. When asked about it, Dr RK Pachauri, director general, TERI agrees that there is a requirement of sensitizing the politicians and parliamentarians on the subject. He cites the example of few European nations where the visits are organized to research labs for understanding the scientific temperament. A very prominent retired administrator suggested that the policy must be based on "ideology of the ruling political party" modulated by science. In a hard hitting question, he asks, "Is there a political ideology that India should have a public health department like in all middle and high income countries and that any preventable disease occurring and even killing individuals is due to governmental negligence?" A serious introspection is required on the part of policymakers on few issues. While socialist and capitalist countries profess that people's health is government responsibility, does any party in India believe in such a policy? Though we have a constitutional mandate that health is human right but we do not practice prevention. The time is ripe for the stakeholders in the sector to make the political parties aware about the sector and its long term implications on nation's overall development, which of course no party can afford to ignore. ]]> <![CDATA[FDI as a key growth driver for Indian pharma industry: F&S]]> https://biospectrumindia.com/news/95/3610/fdi-as-a-key-growth-driver-for-indian-pharma-industry-fs.html https://biospectrumindia.com/news/95/3610/fdi-as-a-key-growth-driver-for-indian-pharma-industry-fs.html Thu, 06 Feb 2014 18:20:00 +0530 According to Dr Saneesh Edacherian, research analyst, Business and Financial Services - Healthcare, Frost & Sullivan, "With a growth rate of nearly 7.0 percent in FY 2013, the pharmaceutical industry has outpaced India's economic growth rate which was less than 5.0 percent for the same period. Though the pharmaceutical industry witnessed a decline in growth compared to previous year, it is one of the largest and the fastest among emerging economies. Indian pharmaceutical exports are expected to grow at a CAGR of 15 percent (Base year 2012) in next 5 years. With more than 55 percent of the drugs sold in highly regulated western markets India has the highest number of USFDA approved manufacturing plants outside USA." The allowance of FDI in pharma sector was well received by foreign investors, the FDI in pharma increased to US $ 1.2 billion in the period April to November 2013 compared to US $ 589 million in the period April to December 2012 according to data released by DIPP. However there were few factors both global and domestic which pulled down the growth of Indian pharmaceutical industry compared to previous years. While the recent notices by FDA to certain sites in India, regarding compliance issues has had a mild impact on the global reputation of Indian pharmaceutical industry, the new drug pricing policy which fixes the price of essential drugs has had a negative impact on domestic sales. Moreover the depreciating rupee has mixed impact of increasing export revenue for large companies but also increasing the cost of raw materials for small local manufacturers. The FDI in pharma has been a welcoming move for the pharmaceutical industry and also to the Indian economy at large. Allowing increased participation of foreign investors in Indian pharma was one of the moves by the Government to reduce the spiraling current account deficit (CAD). The CAD narrowed down from US $ 21 billion in second quarter of FY 2013 to US $ 5.2 billion in second quarter of FY 2014. This is quite evident from the regulatory changes allowing 100 percent FDI in both brownfield and Greenfield projects. Though the Department Of Industrial Policy & Promotion (DIPP) wanted to curb FDI in brownfield projects to 49 percent citing concerns of reduction in production of life saving drugs and increase in price of the drugs available in the market, the Union Government opposed this and allowed 100 percent FDI. The primary reason for this opposition could be that in a country like India where practical and administrative bottlenecks exist, allowing only Greenfield projects is not going to lure foreign investors into the sector and this could not be a solution for increasing CAD in the short term. The M&A involving foreign acquirers also increased from 8 deals in 2012 to 11 deals in 2013, with the total deal value almost increasing 6.4 times between 2012 and 2013. The largest deal involved US $ 1.85 billion acquisition of Agila Specialties Private Limited by the US based Mylan, Inc. In a nutshell the increasing presence of FDI in Indian Pharma is expected to benefit the Industry in the longer run with more significant contribution to country's economic growth. ]]> <![CDATA[Venus gets Indonesian GMP certification for its Baddi unit]]> https://biospectrumindia.com/news/95/3613/venus-gets-indonesian-gmp-certification-for-its-baddi-unit.html https://biospectrumindia.com/news/95/3613/venus-gets-indonesian-gmp-certification-for-its-baddi-unit.html Thu, 06 Feb 2014 18:16:00 +0530 Venus Remedies, a leading R&D-driven pharmaceutical company, has got good manufacturing practices (GMP) certification from Indonesia for its unit located in Baddi, Himachal Pradesh. The Indonesian National Agency for Drug and Food Control (NADFC) granted the certification after an extensive review and audit of the facility. With this, the number of international GMP certifications for Venus Remedies has gone up to 22. The NADFC is among the drug regulatory authorities of 44 countries which are part of the Pharmaceutical Inspection Convention/Co-operation Scheme (PIC/S). Venus Remedies has already got GMP certification from three other PIC/S members, including Ukraine, TGA-Australia and European Union. Indonesia represents one of the most attractive and flourishing markets for pharmaceutical companies looking to expand across the Asia-Pacific region. With a sizable population of 234 million, which is witnessing a rapidly expanding middle class, Indonesia is poised to emerge as a key market of growth for the healthcare and pharmaceutical industry. Currently worth $4.5 billion, Indonesia's pharmaceutical market is expanding at an annual rate of 12.5%. Pharmaceutical sales in Indonesia are expected to register a significant growth in 2012-16 at a compound annual growth rate (CAGR) of 11.5% in terms of the local currency. "A potentially lucrative market for our oncology product line, Indonesia records 170-190 new cancer cases annually in a population of every 1 lakh. The Indonesian oncology market, worth US $88.58 million in 2013, is expected to grow at 10%. We will commercially launch our products in Indonesia by the middle of this year and are projected to generate a revenue of $1 million in the first year itself. With the launch of our oncology products in Indonesia, we aim at capturing the maximum share in the country's pharmaceutical market," said Dheeraj Aggarwal, Chief Financial Officer, Venus Remedies Limited. Commenting on the achievement, Dr Manu Chaudhary, Joint Managing Director, Venus Remedies Ltd and Director, Research, Venus Medicine Research Centre, the R&D wing of Venus Remedies, said, "It is a matter of great pride for us that our tally of PIC/S GMP certifications has gone up to four. Such recognitions for our manufacturing facilities and the consistent quality of our procedures and practices open tremendous opportunities for us to expand our product portfolio across the globe. We are expecting registrations for our 10 oncology products in the next two weeks. This GMP approval will soon pave the way for marketing authorisations from Indonesia." Indonesia offers a growing market for oncology products. Cancer is the sixth most leading cause of death in Indonesia after infectious diseases, cardiovascular diseases, traffic accidents, nutritional deficiency and congenital diseases. According to the WHO, cancer kills more than 7 million people globally every year, and two-thirds of them are from developing countries. In the absence of adequate preventive measures, the number of cancer deaths is expected to go up to 17 million annually by 2030. It is estimated that 26 million people worldwide are suffering from cancer. The WHO and the International Union against Cancer (UICC) have predicted a 300% rise in the number of cancer cases by 2030 with developing countries like Indonesia accounting for 70% of these cases. ]]> <![CDATA[ABLE-AG welcomes PM's statement on GM crops]]> https://biospectrumindia.com/news/95/3614/able-ag-welcomes-pms-statement-on-gm-crops.html https://biospectrumindia.com/news/95/3614/able-ag-welcomes-pms-statement-on-gm-crops.html Thu, 06 Feb 2014 18:07:00 +0530 We welcome Prime Minister, Dr Manmohan Singh's long-awaited statement of the well-known fact that the government should not succumb to "unscientific prejudices" against genetically modified crops. We laud his reaffirmation of his faith in the power of technology when he said "Use of biotechnology has great potential to improve yields. This was stated by Dr N Seetharama, executive director, ABLE AG in a statement issued to the BioSpectrum on February, 06. The statement has come in response to the prime minister, Dr Manmohan Singh's speech made at the Jammu University two days ago, where he inaugurated the Indian Science Congress 2014. Highlighting the importance of biotech for the agricultural goodwill, Dr Seetharama added, "At a time when agriculture is under severe stress and requires immediate infusion of technology and innovation, we can't afford to ignore biotechnology which has a proven track record of enhancing crop yields in a safe and sustainable way the world over." It is important to mention that Dr Manmohan Singh had in his address mentioned that his government remained committed "to promoting the use of these new technologies for agricultural development". He had further added, "To ensure food security and to improve land and water productivity, we have to launch a national drive for an ever-green revolution. This will test the ingenuity of our agricultural scientists. Climate-resilient agriculture and modern bio-technological tools hold great promise. Use of bio-technology has great potential to improve yields", Dr Singh had said. The statement from ABLE-AG also welcomed the positive attitude of the new environment minister."The agri biotech industry aims to contribute towards sustainable and safe food production by facilitating the best biotechnology products and practices for both farmers and consumers. We also welcome Union Environment Minister Mr Veerapa Moily assertion that his ministry will allow field trials of GM crops. Many products from both private and public sector institutions are being tested for safety and efficacy before commercialization under strict regulatory system existing in the country, mentioned the statement from ABLE AG. A record 170.3 million hectares of biotech crops were grown globally in 2012, at an annual growth rate of 6%, up 10.3 million from 160 million hectares in 2011. 2012 was the 17th year of commercialization of biotech crops, 1996-2012, when growth continued after a remarkable 16 consecutive years of increases. India is one of the countries which has adopted this technology on a large scale with outstanding impact, though only a single product of Bt Cotton is available so far to the farmers. ]]> <![CDATA[â€œOur government has lost its trust in scientistsâ€?]]> https://biospectrumindia.com/interviews/95/3611/our-government-has-lost-its-trust-in-scientists.html https://biospectrumindia.com/interviews/95/3611/our-government-has-lost-its-trust-in-scientists.html Thu, 06 Feb 2014 12:02:00 +0530 This nutritional pathologist for over 30 years, joined NIN in 1977 and served as the director of the institute since 2006. Dr Sesikeran shares his views on the state of affairs in GEAC. Excerpts from an interview: Q. What is happening within GEAC as of date? Dr B Sesikeran: The GEAC has not met for a year now. The last time its members came together was inMarch 2013. There have been no meetingsthereafter. I do not know the reasons behind it. The GEAC is currently not offering any approvals for Genetically Modified (GM) crops. Q. Is there a lot of misinformationabout GM crops? Scientifically it is proven beyond any doubt that GM crops are safe for consumption. Unfortunately, people have concocted unscientifically proven stories about GM foods. Activism has taken advantage of these claims and have over taken the scientific community. Even countries like Bangladesh, which are much more backward compared to India, have taken the initiative of approving GM crops, as they found it immensely useful for their famers. Thanks to the Honorable Supreme Court of Bangladesh. Hopefully, our farmers in India might see the benefits and adopt the same. Q. How can we change the current perception about GM crops? Education on GM crops should have started long before commencing its research. If it had, people today would have had more awareness about GM crops. However, this was not done. People here wanted to first carry out the research rather than focuson spreading the awareness. In the meanwhile, many MNCs,who had the technology, started to collaborate with institutions, leading to the creation of local hybrids. Europe had been at the forefront of activism in opposing GM crops. Today, we are followingthe same footsteps. In the last 20 years, the data that we have accumulated evidently shows that GM crops are safe and many researchers have carried out robust studies proving GM crops' safety. Now, it is up to the Ministry of Agriculture and DBT to together educate all stakeholders in this regard. But this can be successful only if there is a political will and even the government will not be able to do anything until our ministers do something about it. I am hopeful that things will soon change. Q. What do you have to say about the hold on GM field trials? There has been huge investments in the GM crops' R&D. Some crops become successful while others don't. So this is purely a trial-and-error concept. Open field trials is the actual test to checkhow the crops perform well and how they grow in different regions of the country and in different climatic zones and seasons. This is the only way to ensure successand usefulnessof crops. If GM crops are not going to be permitted to be grown, then the scientific information on the GM crops is not going to be available in our country. Many expert groups tell researchers to generate more data. Regulations have to be made more robust. But regulations will require field trials which would generate valid scientific data. If this is not done, it is as good as putting an end to GM crops. The government has invested millions in terms of GM research and putting a stop now on GM crop trials doesn't make sense. Q. How can GM crops address the issue of food security? When there is a crop failure during excessive drought or flooding, and we do not find alternatives, then we will have to import food from other countries. This should never happen. Today, the climate varies and we do not know what might happen next month or next year. There is uncertainty about when it might rain or about the availability of sunshine. We can use this technology to grow more food. This is our alternative to agriculture that we must have in our country to face dire situations. If there is a short-fall of food and we end up importing them, then we will lose our sovereignty as a country. Q. How can our political system intervene in these circumstances? The people in our political system should be open to innovative technologies and methods and not be carried away by fears and unnecessary issues. The government should trust scientists and technologies. Off late, the government has lost its trust in scientists. The government listens to one activist but ignores 20 other scientists while making big decisions. In such situations, trust is required which will allow us to go ahead with our research work, which will ultimately benefit the country. ]]> <![CDATA[Jairam Ramesh turns biotech-friendly?]]> https://biospectrumindia.com/features/95/1189/jairam-ramesh-turns-biotech-friendly.html https://biospectrumindia.com/features/95/1189/jairam-ramesh-turns-biotech-friendly.html Thu, 06 Feb 2014 11:41:00 +0530 The former federal environment minister, Mr Jairam Ramesh, who now heads the rural development ministry was a villain to the bioagri industry. For he used his ministerial powers and announced a ban on the cultivation of genetically modified brinjal in February 2010, despite the product getting the regulatory approval. But with General Elections fast approaching in April-May 2014, the minister seems to be turning a new leaf related to biotech. In a widely reported talk in mid-January, Mr Ramesh admitted that the Manmohan Singh government had disappointed the country by failing to set up a modern biotech regulatory agency as envisaged by the Biotechnology Regulatory Authority of India (BRAI) bill now awaiting Parliamentary approval for nearly three years. "It was unfortunate that in the four years since I passed the moratorium order on Bt brinjal, the government, which I am part of, has not been able to fulfil these milestones. One was to put an independent regulator in place, empower them and pass a law. We do not have it (BRAI) in place," Mr Ramesh said at a recent industry event in Delhi. "We need GM crops. We need different forms of GM crops not only the Bt route," he said adding he had issued the moratorium only for a limited period till the pre-conditions for its safe cultivation is met. BioSpectrum learns that the change of mind within the government has come due to the strong support to the cause of biotech voiced by Prime Minister Dr Manmohan Singh recently. It is reliably learnt that Dr Singh has been vocal about science getting priority in these matters over unchecked activism. In view of the Prime Minister's strong support, environment and agriculture ministries are expected to make strong case for allowing field trials of GM crops in the relevant cases coming up before the Supreme Court in the next few weeks. Sources within the government told BioSpectrum that the government will pitch for the cultivation of biotech crops but under stringent conditions. The new environment minister, Mr Veerappa Moily too has started batting for the biotech industry. During his interaction with the media in December soon after taking charge of the ministry, he said, "There is space for everyone. Be it environment, wildlife, or mankind. It is only our mental block which sometimes thinks that there is friction and I think that friction will have to end up with fusion. Mr Moily added, "There are already set rules and laws laid down and we need to perform the duty of a regulator. The rules of the game will have to be strictly followed. As far as possible, nothing should be left to discretion. Ultimately, we have to go by the rules of the game which are laid down by the ministry. We will not compromise on the green image." Sources within the government indicate that Mr Moily will support the initiatives of the Prime Minister, unlike his predecessors who viewed the biotech industry with suspicion and hostility. Good times may finally roll in for the biotech industry ]]> <![CDATA[Venus gets Indonesian GMP certification ]]> https://biospectrumindia.com/news/95/3609/venus-gets-indonesian-gmp-certification-.html https://biospectrumindia.com/news/95/3609/venus-gets-indonesian-gmp-certification-.html Thu, 06 Feb 2014 11:18:00 +0530 Venus Remedies, a leading R&D driven pharmaceutical company, has got Good Manufacturing Practices (GMP) certification from Indonesia, for its unit located in Baddi, Himachal Pradesh. The Indonesian National Agency for Drug and Food Control (NADFC) granted the certification after an extensive review and audit of the facility. With this, the number of international GMP certifications for Venus Remedies has gone up to 22. Indonesia represents one of the most attractive and flourishing markets for pharmaceutical companies looking to expand across the Asia-Pacific region. With a sizable population of 234 million, which is witnessing a rapidly expanding middle class, Indonesia is poised to emerge as a key market of growth for the healthcare and pharmaceutical industry. Currently worth $4.5 billion, Indonesia's pharmaceutical market is expanding at an annual rate of 12.5 percent. Pharmaceutical sales in Indonesia are expected to register a significant growth in 2012-16 at a compound annual growth rate (CAGR) of 11.5 percent in terms of the local currency. Dr Manu Chaudhary, joint managing director, Venus Remedies said, "It is a matter of great pride for us that our tally of PIC/S GMP certifications has gone up to four. Such recognitions for our manufacturing facilities and the consistent quality of our procedures and practices open tremendous opportunities for us to expand our product portfolio across the globe." Indonesia offers a growing market for oncology products. Cancer is the sixth most leading cause of death in Indonesia after infectious diseases, cardiovascular diseases, traffic accidents, nutritional deficiency and congenital diseases. According to the WHO, cancer kills more than 7 million people globally every year, and two-thirds of them are from developing countries. In the absence of adequate preventive measures, the number of cancer deaths is expected to go up to 17 million annually by 2030. It is estimated that 26 million people worldwide are suffering from cancer. The WHO and the International Union against Cancer (UICC) have predicted a 300 percent rise in the number of cancer cases by 2030 with developing countries like Indonesia accounting for 70 percent of these cases. ]]> <![CDATA[Gilead declares Mylan as exclusive branded medicine partner]]> https://biospectrumindia.com/news/95/8117/gilead-declares-mylan-as-exclusive-branded-medicine-partner.html https://biospectrumindia.com/news/95/8117/gilead-declares-mylan-as-exclusive-branded-medicine-partner.html Wed, 05 Feb 2014 15:29:59 +0530 Gilead Sciences, announced that Mylan Pharmaceuticals, the Indian-based subsidiary of Mylan Inc, as its exclusive branded medicine business partner for India. Under the agreement, Mylan will market and distribute in India certain Gilead medications:â€¢ HIV therapies Viread (tenofovir disoproxil fumarate), Truvada (emtricitabine/tenofovir disoproxil fumarate) and the newer single tablet regimen Stribild (elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg)â€¢ AmBisome (amphotericin B liposome for injection), a treatment for life-threatening, systemic fungal infections, which is also used to treat the parasitic disease visceral leishmaniasisâ€¢ Viread for its indication as a treatment for chronic hepatitis B virus (HBV) infection. "The appointment of Mylan as our branded medicine business partner in India is a result of their strong knowledge of the Indian healthcare system and demonstrated capabilities of supporting and distributing antiretroviral therapies," said Mr Gregg H Alton, Gilead's executive vice president of Corporate and Medical Affairs. In addition to distributing branded Gilead medicines, Mylan will manage regulatory and pharma co-vigilance activities (such as adverse event reporting) as well as broader medical education initiatives. ]]> <![CDATA[A comatose regulator, GEAC kills Indian biotech]]> https://biospectrumindia.com/features/95/1193/a-comatose-regulator-geac-kills-indian-biotech.html https://biospectrumindia.com/features/95/1193/a-comatose-regulator-geac-kills-indian-biotech.html Wed, 05 Feb 2014 14:45:00 +0530 The biotech industry leaders are calling this extraordinary state of inaction of the biotech regulatory agency GEAC as the "Jayanthi whiplash" which sent its 16 members into a near coma state for more than 24 months. The shadow Prime Minister of the leading Bharatiya Janata Party (BJP), Mr Narendra Modi, called the status of environment ministry's inaction as "Jayanthi Tax" on industry. The reference is to the former minister, Ms Jayanthi Natarajan, who until recently lorded over the ministry as its head, for 30 months, from July 2011-to-December 2013 until she was replaced by Mr M Veerappa Moily in a surprise cabinet reshuffle. The facts about the regulatory inaction during Ms Natarajan's stewardship of Environment Ministry which handles GEAC is stark. The regulatory body used to meet once a month, on every second Wednesday, since 2005 to clear biotechnology products which are required to get a compulsory approval for its environmental impact from this regulatory agency. GEAC has met only six times during the 30-month tenure of Ms Natarajan. More devastatingly, the last two meetings have taken place after a gap of a year each, which has literally choked the growth of biotech industry that was growing at over 18 percent every year since 2006. As a result, close to 100 important biotech products, many of them life-saving and cost-effective substitutes for imported high-priced medicines, are pending clearances. Millions of India's patients are keenly awaiting the release of these products to prolong their lives impacted by various dreaded diseases. Data compiled by BioSpectrum throws some startling facts. After Ms Natarajan took over as the minister in July 2011, the GEAC met five times-September, October, and December 2011, February 2012 and April 2012.The next meeting was 14 months later on April 11, 2013. The meeting took some decisions. But the minutes of the meeting have not been made public nearly 11 months later. This meeting was the first one of the reconstituted committee which had 16 members. Since April 2013, GEAC has slipped into a "coma" probably on the cues from the minister. "We thought the regulator was only in a hibernation mode, meeting twice in a span of 24 months. But now it appears to be in a state of coma. Can the good Mr Veerappa Moily, the new minister, revive the regulators from its comatose state," asked a worried director of one of the country's top biotech companies. Ms Natarajan had vigorously defended her reign at the ministry when Mr Modi referred to the overall "Jayanthi Tax". The facts speak for themselves who is right. Under Ms Natarajan's predecessor, Mr Jairam Ramesh, who was also considered to be vehemently against the biotech industry, did actually better during his tenure with biotech regulatory clearances. His only blemish was the "misuse" of ministerial prerogative to stop the commercialization of genetically-modified brinjal crop in February 2010 despite it getting the GEAC approval. During the 27-month tenure of Mr Ramesh, from May 2009 to July 2011, GEAC met 17 times, almost once in 45 days and cleared medical and other products at a fast pace. In fact, a GEAC meet had taken place just a few days before his being shifted to another ministry on July 6, 2011. BioSpectrum contacted the current chairman of GEAC, Mr Hem Pande, to know the reasons for the non-functioning of the regulatory agency. Mr Pande, in his capacity as an additional secretary in the Ministry of Environment, chairs the GEAC meeting. Mr Pande and his office chose to ignore all the emails and reminders seeking clarifications and meeting requests from BioSpectrum. Dr Ranjini Warrier, secretary of GEAC, who is tasked with the responsibility of convening the regulatory agency's meetings refused to comment on the reasons for the inexplicable conduct of the regulatory agency. BioSpectrum has spoken to several members of this regulatory body and sought their inputs, on condition of anonymity, due to the sensitive nature of the issue. Most members were at a loss to explain the extraordinary state of affairs. They are all expert members who meet in New Delhi when an official meeting is convened by the Ministry of Environment. The current committee's tenure is for three years, from March 2013 to March 2016. And there has been no work at the regulatory agency for almost a year since the new committee was set up. Some members concede, informally, that the inaction of the regulatory agency could be due to the extra caution being taken by the environment ministry officials due to the intervention of the Supreme Court of India, in two issues-trials of genetically modified crops and clinical trials of drugs developed abroad.But this is just a fig leaf to conceal inaction explained an industry leader. The court has not put a ban on the work of the biotech regulator. There are only some observations related to allowing field trials and clinical trials. Explained Dr Seetharama Nadoor, executive director of bioagri industry group, ABLE-AG, "The honourable Supreme Court has not agreed to the plea of petitioners of a Public Interest Litigation (PIL) to ban field trials of the GM cropsthat are already going on under strict regulatory-vigilance standards." Because of the high visible campaign against GM crops in the country, the regulatory agency has become identified with only this sector and its work in clearing recombinant DNA and other biotech-based medical products hassuffered in the circumstances. On being asked about the over debated issue of genetically modified crops, Dr K VijayRaghavan, secretary, Department of Biotechnology (DBT) mentioned, "Personally I think we have over-reacted. The current debate is focussed on only one aspect. There are other table top technologies such as genome engineering and bio-engineering. I feel the false debate is taking away wheels of the science and widening of thisdebate is required." According to Dr Virander S Chauhan, director, International Center for Genetic Engineering (ICGEB), New Delhi, "The GEAC has not met since a year now. This doesn't make sense. People say that scientists don't have the communication skills to articulate their views but still politicians should not over-run science. Personally we are looking very silly in the eyes of the world." Voices from the industry about the non-functioning of GEAC has been muted so far. Most of the biopharma companies have focused their attention on the near-killing of clinical trials activity in the country due to a Supreme Court order."Well I believe GEAC activity must be continuous and even if thereis a ruling of the Supreme Court, the GEAC must continue to meet and go forward. Many things have affected the outcome of my work. I created something meaningful and significant. And it has been put on a slow trackby lack of funding, regulations, and clarity of guidelines,"mentioned Dr Villoo Morawala-Patell, managing director and chairman, Avesthagen, Bangalore. When asked about GEAC not being able to function properly, Dr MK Bhan, former secretary, DBT, mentioned, "What is sad is that we have not been able to improve our regulatory scenario. So is the motto improvement or hard-stop? You don't stop a child to go out on to the street and play because he will get hurt. Because on apositive note, that is how experiences come through. You don't stop living fearing something might go wrong. Ideology and prejudice rather than ethics and safety are driving this." Many leaders of the scientific community agree with Dr Bhan's observations. Dr Deepak Pental, professor of genetics and former vice chancellor of Delhi University, is very introspective. "Why is the GEAC not being allowed to function? After all nobody is suggesting that government is not the final authority. But in this case, when there are three ministries and bureaucrats on one side and the one ministry on the other side, this is enough to point towards the passage of the BRAI (Biotechnology Regulatory Authority of India) bill. Who would like to work in this area when we first fund it and then don't care enough later? How long will we ignore scientists and science for politics? The reason for this chaos is that we as scientists have not worked as a team and raised enough voices." Some HopesEven though GEAC was in existence since early 1990s, its initial meetings were sporadic. After the biotech industry came into being after 1999, intense campaigns resulted in the government agreeing to regular monthly meetings to clear pending proposals. One of the most appalling facts about the last ever meeting of GEAC in April 2013 is that most of the key members were absent. According to the regulatory agency's charter, the presence of one-third of the 16 members is enough to constitute a quorum. There may not have been a quorum at that meeting suspect industry leaders. BioSpectrum tried its best to get information on the proceedings of the April 2013 meeting without any success. However, some good news is on the way. BioSpectrum understands that GEAC may meet very soon. The new minister, Mr Moily has turned his attention to this agency. Mr Moily is set to meet the industry during the annual edition of Bangalore India Bio in Bangalore on February 10, 2014. He may want to avoid the ire of the country's biotech leaders on this count. Also, sources in the GEAC indicated that the regulator may clear 35-40 long pending product applications. Earlier, the Maharashtra government in December 2013 granted No Objection Certificates (NOCs) to 28 applications from seven companies for confined field trials. Despite the opposition from within the state government, the chief minister of the state decided to give the nod on a case-to-case basis. The NOCs have been granted to transgenic varieties of brinjal, cotton, maize, rice, and wheat. The companies granted clearances include Ankur Seeds, Bayer Bio Science, Dow Agro Sciences India, Mahyco, Monsanto India, Pioneer Overseas Corporation, and Syngenta Bio Sciences. The government's Central Institute for Cotton Research has also been given an NOC. The move has got support from the union agriculture ministry. Meanwhile Ms Aruna Rodrigues, an anti-GM activist whose public interest litigation (PIL) in the Supreme Court is going on, was quoted as saying that the Prime Minister has an agenda to foster biotechnology with the support of USA. "If the Prime Minister has overruled Ms Jayanthi Natarajan and appointed a new environment minister to do his bidding, then science goes out of the window," she mentioned in her statement to media. The anti-GM activists are expected to oppose any such move both in courts and on streets. With the parliament likely to meet in February 2014 again before the elections, it would be interesting to see how the things turn out for the crucial BRAI bill and the GEAC. ]]> <![CDATA[Chronic obstructive pulmonary disease still unknown to many]]> https://biospectrumindia.com/news/95/6711/chronic-obstructive-pulmonary-disease-still-unknown-to-many.html https://biospectrumindia.com/news/95/6711/chronic-obstructive-pulmonary-disease-still-unknown-to-many.html Wed, 05 Feb 2014 12:07:00 +0530 'India needs a National Chronic Obstructive Pulmonary disease Prevention and Control Program (ICONIC)' - this was discussed at the 1st International Conference of Chronic Obstructive Pulmonary disease (COPD) held at Pune. Mr Keshav Desiraju, secretary, Ministry of Health & Family Welfare, inaugurated the first conference focusing on Chronic Obstructive Pulmonary disease (COPD) in India. The conference has 18 overseas faculty and 15 national speakers which is jointly hosted by Chest Research Foundation (CRF) and Johns Hopkins Bloomberg School of Public Health, USA. Speaking at ICONIC 2014, Dr Sundeep Salvi, director, Chest Research Foundation said, "ICONIC brings together experts across the healthcare industry including physicians, public health policy makers and researchers to bridge gaps in the field of COPD prevention, control and management in India. It is an opportunity to share the latest developments in COPD research both from US and India, which they can use it to treat their patients better." Dr Shyam Biswal, Department of Environmental Health Science, John Hopkins School of Public Health, USA, said, "ICONIC serves as a great platform for young researchers and physicians to showcase their research work and receive constructive feedback from the leading experts in the world. It will also help them to polish and shape their research studies so that they can derive meaningful and qualitative data that will benefit the world. Further, it also creates opportunities for doctors in America and India to come together to form collaborations for exchange of knowledge which will help to combat the COPD epidemic." In India, people are aware of diseases such as cancer, diabetes, hypertension, but a condition like COPD still remains unknown to many. Further, due to lack of awareness by healthcare providers, many patients' remain poorly diagnosed and even wrongly treated. ]]> <![CDATA[Suven gets patents for NCE in Canada, China and India ]]> https://biospectrumindia.com/news/95/5222/suven-gets-patents-for-nce-in-canada-china-and-india-.html https://biospectrumindia.com/news/95/5222/suven-gets-patents-for-nce-in-canada-china-and-india-.html Tue, 04 Feb 2014 07:05:00 +0530 Bangalore: Suven Life Sciences received three product patents one each from Canada (2600271), China (CN 101544592B) and India (257850) for its new chemical entities (NCEs) for the treatment of disorders associated with neurodegenerative diseases. The patents are valid through 2025. The granted claims of the patents include the class of selective 5-HT compounds discovered by Suven and are being developed as therapeutic agents and are useful in the treatment of cognitive impairment associated with neurodegenerative disorders like Alzheimer's disease, Attention deficient hyperactivity disorder (ADHD), Huntington's disease, Parkinson and Schizophrenia. Suven now has a total of 14, 12 and 17 patents from Canada, China and India respectively. These granted patents are exclusive intellectual property (IP) of Suven and are achieved through the internal discovery research efforts. Products out of these inventions may be out-licensed at various phases of clinical development like at phase I or phase II. Suven, whose products are first in class or best in class CNS therapies through the use of GPCR targets, has 12 internally-discovered therapeutic drug candidates currently in pre-clinical stage of development targeting conditions such as ADHD, dementia, depression, Huntington's disease, Parkinson's disease and obesity in addition to developmental candidate SUVN-502 for Alzheimer's disease and Schizophrenia. "We are very pleased by the grant of these patents to Suven for our pipeline of molecules in CNS arena that are being developed for cognitive disorders with high unmet medical need with huge market potential globally" says Mr Venkat Jasti, CEO, Suven. ]]> <![CDATA[Bangalore India BIO 2014 - What is the agenda?]]> https://biospectrumindia.com/features/95/3607/bangalore-india-bio-2014-what-is-the-agenda.html https://biospectrumindia.com/features/95/3607/bangalore-india-bio-2014-what-is-the-agenda.html Mon, 03 Feb 2014 23:08:01 +0530 Bangalore India BIO 2014 (BIB 2014), which will be inaugurated on February 10, 2014, is expected to see the highest-ever participation from delegates since its inception 14 years ago. BIB 2014 will feature will focus on the core theme of "Biotech for a Better Tomorrow." To see what is in store on each of the days of the mega event, please click here: Day 1: Conference AgendaDay 2: Conference AgendaDay 3: Conference Agenda The event will witness the presence of Professor Sir John Gurdon, Nobel Laureate for the year 2012 in Physiology or Medicine and Emeritus Professor Dr Marc Van Montagu, the 2013 World food prize Winner, among many other illustrious individuals. Besides the multi-track conferences, international tradeshow, distinguished lectures and talks, Bangalore India BIO 2014 will also feature B2B meetings, CEO conclave, presentation of the Bio Excellence Awards, finals of the BioQuiz, business delegation meetings and other networking events. There is strong International participation from nearly 20 countries with large delegations from Scotland, UK, EU, Neurosciences Victoria, Atlanta-Georgia, South Korea and Malaysia. A session on research, innovation and higher education cooperation and opportunities between India and the European Union and a special focus on developing strategic relationships between India and Melbourne in Neuroscience will be held. Emory vaccine center will hold a session on exploring further Indo-US as well as global partnerships for vaccine research and the UK Trade and Investment (UKTI) will hold a session on collaborative opportunities with India, amongst other topics. The conference will feature 25 conference sessions, an important panel discussion, and also a Fireside Chat has been included that will focus on the increasing role of technology in healthcare. A round table discussion on 'Harmonization of global regulatory framework with special focus on Asia Pacific', has also been scheduled with regulators invited from the key countries such as Malaysia, UK, Korea, Australia and India. The CEO conclave will be an exclusive gathering of CEOs, R&D heads, policy makers, venture capitalists and investment bankers. The highlight of the CEO conclave will be the panel discussion on 'Scaling up biotech companies to handle the changing business environment'. Bio Excellence Awards will recognize the contribution of start-up and young biotech companies and individuals for their outstanding achievements in the field of biotechnology. Exhibitor awards for best deigned and informative booths and poster presentation awards will also be presented during Bangalore India BIO 2014. The trade-show will see participation from about 100 companies from various verticals of life sciences industry like biopharmaceuticals, bio-suppliers, bio-informatics, bio-medical devices in Bangalore India BIO 2014. The poster session at the event will have nearly 60 posters that provides a wonderful platform for young researchers and scientists from industry, research institutions and academia to present innovative ideas, outstanding research or path-breaking study in the field of biotechnology. ]]> <![CDATA[Victoria Neuroscience to 'Brain Storm' at Bangalore India BIO]]> https://biospectrumindia.com/features/95/3604/victoria-neuroscience-to-brain-storm-at-bangalore-india-bio.html https://biospectrumindia.com/features/95/3604/victoria-neuroscience-to-brain-storm-at-bangalore-india-bio.html Mon, 03 Feb 2014 22:26:00 +0530 ]]> <![CDATA[Mylan launches first biosimilar in India]]> https://biospectrumindia.com/news/95/3612/mylan-launches-first-biosimilar-in-india.html https://biospectrumindia.com/news/95/3612/mylan-launches-first-biosimilar-in-india.html Mon, 03 Feb 2014 18:39:00 +0530 Mylan Pharmaceuticals, Indian subsidiary of leading generic company - Mylan Inc, has launched the world's first trastuzumab biosimilar in India. The product, will be marketed by Mylan under the brand name Hertraz, is a biosimilar to Roche's Herceptin. Hertraz is indicated for the treatment of HER2-positive metastatic breast cancer and is available in two strengths, 440 mg and 150 mg. Trastuzumab is one of the five biologic products Mylan is developing in partnership with Biocon for the global marketplace. Mylan has exclusive commercialization rights for biosimilar trastuzumab in the US, Canada, Japan, and Australia, New Zealand and in the European Union and European Free Trade Association countries and co-exclusive commercialization rights with Biocon for product in India. Mylan President, Mr Rajiv Malik added, "The launch of Hertraz is of particular significance as it represents both Mylan's first biosimilar and the world's first trastuzumab biosimilar. We look forward to expanding our portfolio of high quality and affordable biosimilar offerings, particularly in the oncology care segment, in India and around the world in the coming years." Hertraz was approved by the Drug Controller General of India. In support of this approval, Mylan conducted an extensive series of physicochemical and functional assays to demonstrate similarity to the reference brand Herceptin. These analytical methodologies confirmed the high degree of molecular similarity as well as biological activity of Hertraz. In addition, Mylan conducted a multi-center clinical trial to demonstrate comparable safety and efficacy to the reference product. ]]> <![CDATA[Daiichi may step in to resolve Ranbaxy's quality issues]]> https://biospectrumindia.com/news/95/3601/daiichi-may-step-in-to-resolve-ranbaxys-quality-issues.html https://biospectrumindia.com/news/95/3601/daiichi-may-step-in-to-resolve-ranbaxys-quality-issues.html Mon, 03 Feb 2014 18:00:50 +0530 As per reports, the Daichii Sankyo has conveyed that the recent banning of Ranbaxy's plant in Punjab (India) would inevitably affect its earnings. The company hasn't so far given any concrete numbers. The company is not thinking about reducing its stake in Ranbaxy although financial support would be among the actions it will look at. The U.S. Food and Drug Administration has banned Ranbaxy's Toansa plant, a key supplier of ingredients to the generic drugmaker's U.S. factory, from sending its products to the United States due to manufacturing violations. It was the fourth Ranbaxy plant to be shut out of the U.S. market. Daiichi Sankyo's shares are down nearly 10 percent since last week's news on the Toansa plant. Last week, they rose 2.7 percent to 1,723 yen, bouncing from a five-month low hit the day before. ]]> <![CDATA[PM publicly endorses GM crops, hints at corrective steps in coming days]]> https://biospectrumindia.com/news/95/4664/pm-publicly-endorses-gm-crops-hints-at-corrective-steps-in-coming-days.html https://biospectrumindia.com/news/95/4664/pm-publicly-endorses-gm-crops-hints-at-corrective-steps-in-coming-days.html Mon, 03 Feb 2014 17:14:00 +0530 Although there have been many instances in the past when the prime minister, Dr Manmohan Singh had subtly expressed his support for GM crops. But this time he has come out openly to bat for it. The remarks in support of GM technology came during his address to the 101st Indian Science Congress, in Jammu on February 03, 2014. Dr Singh in his speech spoke about need for recognising the government the efforts of scientists and focus on creating new opportunities for our bright and socially conscious scientists. "To ensure food security and to improve land and water productivity, we have to launch a national drive for an ever-green revolution. This will test the ingenuity of our agricultural scientists. Climate-resilient agriculture and modern bio-technological tools hold great promise." "Use of bio-technology has great potential to improve yields. While safety must be ensured, we should not succumb to unscientific prejudices against Bt. crops. Our government remains committed to promoting the use of these new technologies for agricultural development. I urge our scientific community to increase communication and engagement with society at large in explaining socially productive applications of technology alternatives and for improving the productivity of small and medium enterprises," remarked Dr Singh. The prime minister also expressed hope that the quest for affordable healthcare would be bolstered by indigenous research on biomedical engineering and other medical devices. Talking about funding new initiatives, he mentioned, "I am happy to announce another National Mission on High Performance Computing with an outlay of Rs. 4500 crores. We are also considering establishment of a National Geographical Information System with an outlay of about Rs. 3000 crores. A National Mission on Teaching to enhance the esteem of our teachers is also being launched." He also announced that India would partner the international scientific community in the establishment of some of the world's major R&D projects. Dr Singh further said, "We must also seek global leadership in at least some research and development areas. Affordable innovations for human healthcare, sustainable agriculture, clean energy and total solutions for water-related challenges are some areas where Indian science can seek global leadership." ]]> <![CDATA[Novartis to cut or transfer up to 4,000 pharma jobs to India]]> https://biospectrumindia.com/news/95/4789/novartis-to-cut-or-transfer-up-to-4000-pharma-jobs-to-india.html https://biospectrumindia.com/news/95/4789/novartis-to-cut-or-transfer-up-to-4000-pharma-jobs-to-india.html Mon, 03 Feb 2014 16:36:00 +0530 Swiss drugs group Novartis intends to cut or transfer up to 4,000 jobs, newspaper NZZ am Sonntag reported on Sunday, citing an internal email. The plan affecting up to six percent of its pharmaceuticals workforce comes on top of a program to reduce the number of production sites and is part of a larger drive to cut costs, the newspaper said. Global drugmakers are under intense pressure from investors to step up restructuring as patents on best-selling drugs expire and governments try to keep a lid on health costs. Company spokesman Eric Althoff did not confirm the job numbers but issued a statement saying that Novartis intends to prioritize and reallocate resources primarily in pharmaceutical operations to emphasis on planned product launches and other growth areas. The measures "reflect the need to respond to a dynamically changing healthcare environment", it said, adding that Novartis expects group headcount to remain largely flat in 2014. "We expect that an equal number of jobs will be created as are reduced," the statement said. A noteworthy number of jobs are expected to be moved to India, with the company saying that it plans to move existing operations in Hyderabad to a business services center as part of its consolidation strategy. "The new center is expected to open -in late 2015 or early 2016 and will bring together Novartis operations that are currently spread across three sites in Hyderabad as well as provide for future growth," the statement said. Novartis, which will face copycat rival for blood pressure pill Diovan once Ranbaxy Laboratories overcomes regulatory delays for its generic version, posted lower than expected core earnings per share last week. The company is also piloting a review of its over-the-counter, animal health and vaccines businesses, which lack the global scale of its pharmaceuticals operations. ]]> <![CDATA[AstraZeneca should gift its R&D center to Bangalore]]> https://biospectrumindia.com/features/95/4027/astrazeneca-should-gift-its-rd-center-to-bangalore.html https://biospectrumindia.com/features/95/4027/astrazeneca-should-gift-its-rd-center-to-bangalore.html Mon, 03 Feb 2014 11:23:00 +0530 AstraZeneca took the national biotech community by surprise by its sudden announcement on January 30, 2014, that it will shut its research center in Bangalore. The swanky center, employing 165 scientists, who are trying to find a cure against dreaded diseases like tuberculosis and malaria, has been a showpiece of Bangalore as well as for AstraZeneca's global network of nine research centers. According to the AstraZeneca announcement, scientists will start leaving by April and the high tech research facility will close later this year. Can this advanced research center be salvaged and its high tech laboratories put to better use after the UK-based multinational AstraZeneca's disinterest in running it? The facility has a rich history and started as Astra Research Center India. It was one of the country's first corporate R&D facility in biotechnology that came up after the Indian government liberalized the rules to allow such facilities in the country in the mid-1990s. Yes. The center can easily be saved provided there is a strong will on the part of the Karnataka government to do so. BioSpectrum suggests that "Operation Salvage AstraZeneca" as a three-step process. Step 1: AstraZeneca should be persuaded to gift the facility that sits on a 14,200 square-meter plot to the Government of Karnataka as a goodwill gesture for benefiting from the presence in the state for more than two decades. Step 2: The Karnataka government should set up a separate society or a not-for-profit company and take over the facility to run it's as a biotech incubation center. The research facility has advanced equipments worth more than $10 million (Rs 60 crore) at current value, which will be of immense use to start-up companies in Bangalore and elsewhere. The Indian Institute of Science (IISc), which played a key role in setting up the center in the early 1990s, could partner with the state to run it. Step 3: The Department of Biotechnology (DBT), Government of India, and other multinational companies operating in Bangalore should pitch in with funds to help run this as a national facility. Similar things have happened abroad in the recent past. AstraZeneca itself has done this in Montreal city in Quebec, Canada, in 2012. AstraZeneca closed its neuroscience research center in Montreal in February 2012 that employed 130 scientists. However, the Quebec government salvaged it by forming a cooperative venture called NeoMed Institute, supported by the state and the Canadian government. AstraZenca gifted the facility to Quebec and also provided $5 million. Pfizer, which has operations in Quebec, put in another $3.5 million. Furthermore, the governments and other agencies arranged over $100 million. By December 2012, the new center had started functioning as an incubator. Similarly, Merck Sharp & Dohme "gifted" its $150 million (Rs 900 crore) advanced research center near Glasgow, Scotland, when it decided to close it in February 2012. The facility was taken over by BioCity Scotland, a joint venture between BioCity Nottingham and Roslin BioCenter, both biotech incubators, under the guidance of Scottish government. Today BioCity Scotland is a thriving biopark housing dozens of biotech companies. If there is a will, there is a way, for the Karnataka government to restore a research center, which is part of Bangalore's and Karnataka's rich scientific heritage. The ball is in the court of the Karnataka chief minister Mr Siddaramaiah. ]]> <![CDATA[Prominent experts to support GAVI alliance ]]> https://biospectrumindia.com/news/95/3563/prominent-experts-to-support-gavi-alliance-.html https://biospectrumindia.com/news/95/3563/prominent-experts-to-support-gavi-alliance-.html Sat, 01 Feb 2014 12:05:00 +0530 Nine prominent Indians announced today that they have agreed to support the goal of increasing access to immunisation and reducing child mortality across the country. They will work with the GAVI Alliance, a public private partnership made up of members including the World Health Organization (WHO), United Nations International Children Emergency Funding (UNICEF), the World Bank and the Bill and Melinda Gates Foundation, as members of the GAVI Advisory Council in India. Together the nine prominent figures, drawn from Indian politics, public health and media, will provide strategic advice and thought leadership. The inaugural members of the Council are: ï‚· Baijayant Jay Panda, Member of Parliament, Lok Sabha ï‚· Nand Kishore Singh, Member of Parliament, Rajya Sabha ï‚· Harshavardhan Neotia, Chairman, Ambuja Neotia Group ï‚· Dr. Vishwajeet Kumar, CEO, Community Empowerment Lab ï‚· Shabana Azmi, actor, social activist ï‚· Bachi Karkaria, journalist ï‚· Yuvraj Singh, cricketer, child health and cancer activist ï‚· Sangitha Reddy, Executive Director, Apollo Hospitals Group ï‚· Dr C P Bansal, President, South Asia Paediatric Association "GAVI needs India's partnership and support to work with India to reduce child mortality," said Dr Seth Berkley, CEO of the GAVI Alliance. "These eminent personalities from different fields, will reinforce our efforts in the policy discourses on child health and advise the GAVI secretariat and partners on the challenges of immunisation and the introduction of new vaccines in India," Dr Berkley added."I am delighted to be launching this council, and I sincerely welcome and am grateful for the acceptance of its inaugural members." India currently accounts for nearly 20% of the world's child deaths and there are still nearly seven million unimmunised children across the country, the largest number of any country and one third of all unimmunised children in the world. The majority of the world's poorest countries are benefitting from vaccines manufactured in India to save lives but paradoxically some of these vaccines are not yet available to all Indian children. Members of the council have been selected for their expertise and prominence in their respective fields and will comment and advise in a personal capacity. They will also work closely with members of GAVI Alliance to build effective joint strategies to tackle child survival challenges and save more children from vaccine preventable diseases. ]]> <![CDATA[Bayer CropScience India gets new MD]]> https://biospectrumindia.com/news/95/3484/bayer-cropscience-india-gets-new-md.html https://biospectrumindia.com/news/95/3484/bayer-cropscience-india-gets-new-md.html Sat, 01 Feb 2014 07:05:00 +0530 Mumbai: The board of directors of Bayer CropScience India, at a recently held meeting in Mumbai on January 30, 2014, appointed Mr Richard van der Merwe as the managing director and vice chairman of Bayer CropScience India. Mr Merwe appointment will be effective from February 1, 2014. In addition, he will be the Bayer representative for South Asia, based in Mumbai. Mr Merwe succeeds Mr Stephan Gerlich, who will take new responsibilities as the new Bayer representative for Mexico. Mr Gerlich has been the country head of Bayer in India since 2003. ]]> <![CDATA[BIB 2014: Carnival for the Biotech sector]]> https://biospectrumindia.com/news/95/3603/bib-2014-carnival-for-the-biotech-sector.html https://biospectrumindia.com/news/95/3603/bib-2014-carnival-for-the-biotech-sector.html Fri, 31 Jan 2014 16:09:00 +0530 The Bangalore India Bio (BIB) 2014, one of the most awaited annual event of the Indian bioscience industry with the core theme, "Biotech for a Better Tomorrow", will be held on February 10-12, 2014, at The Lalit Ashok, Bangalore. The Bangalore India Bio conference will see participation of over 110 speakers from more than 20 countries bringing together global leaders, scientific minds, policy makers, regulators and investors to exchange ideas and findings in the Biotech sector. "It connects the vibrant industry across the section," informed Mr BM Vijay Shankar, MD, KBITS, Karnataka. Nobel Laureate Sir John Bertrand Gurdon will deliver a distinguished lecture at India's biggest biotech show. Also, 2013's World Food Prize Laureate Em. Prof Marc Van Montagu, founder and chairman, Institute for Plant Biotechnology Out- reach (IPBO), Belgium, will address the gathering. The focus areas in the conference are the international conference that will offer a platform for discussion and deliberation on key issues. It will also have a round table session on the harmonization of the global regulatory framework which will be organized with international regulators from Taiwan, Korea, Singapore, Japan and Hong Kong. While these were the main high- lights of the event, there are many other sessions that will focus on themes like What's next for stem cells and regenerative medicine; bio- medical devices and digital health fueling a revolution in healthcare; biosimilars-attaining global standards; new and innovative models for drug discovery & development through partnerships; India, a destination of choice for clinical trials; how do we gain lost ground, Pharmacogenomics, biomedical informatics and personalized medicine and half day module on agri biotech and secondary agriculture: needs of the nation. Bangalore India Bio is an annual event organized by the Department of IT, BT and S&T, Government of Karnataka, under the guidance of Vision Group on Biotechnology, an apex advisory body comprising of members from government, public and private sectors including industry and academia. The event is managed by MM Activ Sci-Tech Communications, the publisher of BioSpectrum. The detailed three day event will not only have multi-track conferences, an international trade show, biopartnering, but also special pro- grams like the CEO conclave, student activities and an opportunity for the industry to showcase new initiatives. The congregation of top biotech industry leaders, high-ranking policymakers from state and central governments, representatives of International trade commissions, research heads from private and public research organizations and academia makes it a very unique forum. ]]> <![CDATA[Sun's research firm gets DCGI nod for cancer drug]]> https://biospectrumindia.com/news/95/5724/suns-research-firm-gets-dcgi-nod-for-cancer-drug.html https://biospectrumindia.com/news/95/5724/suns-research-firm-gets-dcgi-nod-for-cancer-drug.html Fri, 31 Jan 2014 16:06:45 +0530 Sun Pharma Advanced Research Company (SPARC) announced that its licensee has received an approval from the Drug Controller General of India (DCGI) for Paclitaxel injection concentrate for Nanodispersion (PICN), indicated for the treatment of metastatic breast cancer. In a clinical study in metastatic breast cancer patients, PICN was found to be equally effective and safe when compared to Abraxane. PICN is approved in India for both 260mg per metre square and 295mg per metre square doses to be administered every 3 weeks. PICN is a novel formulation of Paclitaxel using SPARC's proprietary Nanotecton platform technology and is a Cremophor and albumin-free formulation. It offers the convenience of a quick and easy one-step dilution and ifusion preparation for healthcare professionals. PICN can be administered in a short 30 minute infusion and unlike conventional Paclitaxel formulations it does not require premedication with steroids and anti-histamines and does not lead to any significant hypersensitivity reactions in patients. ]]> <![CDATA[Poonam Singh to head WHO in South East Asia]]> https://biospectrumindia.com/news/95/3145/poonam-singh-to-head-who-in-south-east-asia.html https://biospectrumindia.com/news/95/3145/poonam-singh-to-head-who-in-south-east-asia.html Fri, 31 Jan 2014 16:04:05 +0530 Dr Poonam Khetrapal Singh takes charge as the WHO regional director for South East Asia from February 01, 2014. She was elected by the 11 Member States of the region in September 2013 and wassubsequently appointed by the WHO to its executive board at its 134th session in January 2014. Dr Khetrapal Singh is an Indian national and the first woman to hold this post. Committing to excellence, Dr Khetrapal Singh said, "It is a great honour to be appointed Regional Director at an important moment in the history of public health and at a time when WHO is undergoing reform." The South East Asia region is expected to be certified polio free by the WHO in March 2014. "I am steadfast in my resolve to bring change, to explore new avenues and to build partnerships for a technically sound, committed and dynamic WHO to meet each and every public health challenge in South East Asia," added Dr Singh. Dr Singh served for over two decades as a civil servant in India, as a member of the Indian Administrative Services. She was the secretary health, family welfare and medical education in the State of Punjab, which has a population of 22 million and a health budget of $350 million. In 1987 she moved to the health, population and nutrition department of the World Bank. In 1998, she joined WHO headquarters as executive director, sustainable development and healthy environments, and was a member of the cabinet of then director general, Dr Gro Harlem Brundtland. Dr Singh served as WHO deputy regional director for the South East Asia region from 2000-13. In February 2013, she joined the Ministry of Health and Family Welfare of the Government of India as advisor for international health, where her principal task was to strengthen global health outcomes and provide guidance to the ministry to take forward the international health agenda. ]]> <![CDATA[Biocon, Advaxis joins hands for cancer therapy]]> https://biospectrumindia.com/news/95/3606/biocon-advaxis-joins-hands-for-cancer-therapy.html https://biospectrumindia.com/news/95/3606/biocon-advaxis-joins-hands-for-cancer-therapy.html Fri, 31 Jan 2014 15:25:00 +0530 Biocon joined hands with Advaxis, the leading developer of immunotherapies for cancer. They have entered into an exclusive licensing agreement for co-development and commercialization of ADXS-HPV, a novel cancer immunotherapy for the treatment of human papillomavirus (HPV) associated cervical cancer in women, for India and emerging markets. The agreement also gives biocon an upper hand by providing access to Advaxis's innovative and proprietary immunotherapy technology. The motto of gaining the access to innovative technology is to further develop new novel therapeutics for various other unmet medical conditions. "Biocon is committed to finding solutions for women's health issues. This partnership will enable us to develop ADXS-HPV a novel immunotherapy to combat cervical cancer in women. It is a promising technology that has the ability to suppress the tumor inside the micro-environment" said Dr Kiran Mazumdar-Shaw, chairperson and managing director, Biocon. Commenting on the collaboration Mr Daniel J O'Connor, chief executive officer, Advaxis, commented that, "We are excited to partner with Biocon and bring our innovative cancer immunotherapy for cervical cancer to women with few alternatives." He further added, "This agreement give us the opportunity to penetrate into key markets where the number of patients with HPV-associated cancers is in masses." According to the WHO, in 2008, 90 percent of cervical cancer were recorded in developing countries out of 530,000 new cases of cervical cancer all over the world. Over 366 million women of the age of over 15 years are at a risk of developing cervical cancer. It is reported that each year near around 134,000 women are diagnosed with cervical cancer in India and nearly 73,000 is the morbidity rate from this cancer. Further to this, Biocon's president of R&D, Dr Abhijit Barve, expressed that, "The clinical data generated so far with ADXS-HPV look very encouraging in patients with advanced metastatic disease who were resistant or refractory to existing therapies. The clinical responses were comparable to prevalent chemotherapy agents and this was achieved with very low incidence of adverse events. Hence ADXS-HPV is likely to offer patients a safe and effective alternate to chemotherapeutic agents." ]]> <![CDATA[The Netherlands, India enter brain research deal]]> https://biospectrumindia.com/news/95/1167/the-netherlands-india-enter-brain-research-deal.html https://biospectrumindia.com/news/95/1167/the-netherlands-india-enter-brain-research-deal.html Fri, 31 Jan 2014 13:05:00 +0530 The union minister of science and technology and earth sciences, Mr S Jaipal Reddy and minister of health welfare and sports, government of the Netherlands, Ms Edlth Schippers on January 30, 2013, launched a unique project to be conducted by the All India Institute of Medical Sciences AIIMS), New Delhi, and supported by the department of biotechnology (DBT) and its institute at Manesar (Haryana), the National Brain Research Centre, Gurgaon. Speaking on the occasion Mr Jaipal Reddy said, through this process we hope, not only to help people at risk but also define known or novel risk factors that place people at risk of developing health problems mainly related to brain. He expressed hope that this project will serve as a model and training ground for similar initiatives of other parts of our huge and diverse country. Ms Edith Schippers said the Eramus University Medical Centre has committed to provide training and intellectual inputs to people who will work in this project. The secretary, DBT, Dr K Vijayraghawan said this project is designed to serve as a unique model in the sense that instead of usual practice of people seeking help for cure of their diseases at AIIMS, it is the AIIMS which in this project will seek people at risk to prevent diseases. The project focuses on people above 50 years of age in one rural and one urban area. Social Workers will screen people in the adopted areas, invite them to AIIMS even if they have no symptoms, assess the health of their brain,heart and blood, ask their food habits; give them necessary advice and follow them 6-monthly on phone and physically every three years. The project's underpinning is the oft quoted axiom "Prevention is better than cure", he added. Dr M C Mishra, director of AIIMS said that the institute stands to gain from this collaboration with the Netherland's experience on running world- famous similar study at Rotterdam for last 25 years with over 1000 research papers. He said AIIMS plans to use data so generated to conduct several research projects to derive new knowledge that will help the country to develop preventive strategies. It was specified during the launch that this is a unique project to develop a model and test strategies to prevent stroke and dementia as well as heart attacks; and hopefully inspire and support other similar projects in India. The Indo-Dutch collaboration capitalizes on the experience of Dutch Scientists who have been running similar projects in their country (Rotterdam study). Netherlands partners also stand to learn from unique cultural characteristics of India, from exchange visits of scientists and research workers and from the new generalizeable knowledge that emerges from this study. ]]> <![CDATA[Venus Remedies bags US patent for Achnil]]> https://biospectrumindia.com/news/95/6645/venus-remedies-bags-us-patent-for-achnil.html https://biospectrumindia.com/news/95/6645/venus-remedies-bags-us-patent-for-achnil.html Fri, 31 Jan 2014 12:34:00 +0530 Venus Remedies, a research-oriented global pharmaceutical company, has bagged a patent from the United States Patent Office for Achnil, a once-a-day painkiller injection developed by the Venus Medicine Research Centre (VMRC), the R&D wing of Venus Remedies. The patent will remain in force till 2032. The company made the official announcement to this effect on January 29, 2014. "The formulation will be commercialised in the US market through technology transfer/outlicensing of exclusive marketing rights route, and we are open to such deals," said Venus Remedies Chief Financial Officer Mr Dheeraj Aggarwal. Containing aceclofenac, a non-steroidal anti-inflammatory drug (NSAID), Achnil is a pioneering product developed by the VMRC in its efforts to develop a controlled release formulation based on the novel drug delivery system. While the US represents the largest market for pain management worldwide, NSAIDs account for 28% of the global painkiller market, the size of which was US $10.22 billion in 2013. The share of injectables in this market is 15%, making it a market worth US $1.5 billion. Expected to grow at a compound annual growth rate (CAGR) of 3.1%, this potential market for Achnil will be worth US $1.75 billion by 2018. It is estimated that 215 million people in the US aged 20 years and above either suffer from pain in one or more body parts, including joints, lower back, neck and face/jaw, or undergo dental pain and headaches/migraines. About 70 million surgical procedures are performed annually in the US and 80 per cent of these patients experience post-surgical pain, of which cases of severe pain constitute 11-20 per cent. In 2012, more than 31 million non-fatal traumatic cases accompanied by severe pain were recorded. A recent survey found that 25% of the US population suffers from musculoskeletal or lower back pain, 18% suffer from neck pain and 17% from knee and shoulder pain. Achnil is the best and safest option to address such pains. The aceclofenac-based formulation can relieve acute as well as chronic pain and inflammation arising from rheumatoid arthritis, osteoarthritis, lower back pain, ankylosing spondylitis, and dental, post-traumatic pain, gynaecological and cancer-related pains. An aceclofenac injection is effective for 24 hours as against the conventional daily dose of three injections of diclofenac given every 8 hours. It not only reduces the number of pricks but also drastically reduces the side-effects associated with the frequent use of NSAIDs. Aceclofenac is designed in such a way that the product is never released in super or sub-therapeutic zones and is hence highly safe and practically free from side effects. It took the VMRC more than five years to develop this product, which has received an overwhelming response from the medical fraternity in India since it was launched in the country two years ago. It is projected that the global market for pain management will reach US $60 billion by 2015. More than 1.5 billion people worldwide suffer from chronic pain of varying degrees. An estimated 3-4.5% of the global population suffers from neuropathic pain, the incidence of which increases in direct proportion to age. "In view of the rise in the population of elderly people in regulated markets and absence of safer pain management therapies, the demand for better products to address acute and chronic pains is also on the rise. We have developed Achnil to address this unmet need," said Dr Manu Chaudhary, Joint Managing Director, Venus Remedies Ltd, and Director, Research, VMRC.Venus has also secured a US patent for its novel research products Elores, Potentox and Vancoplus. ]]> <![CDATA[Theramyt opens new facility in Bangalore]]> https://biospectrumindia.com/news/95/3621/theramyt-opens-new-facility-in-bangalore.html https://biospectrumindia.com/news/95/3621/theramyt-opens-new-facility-in-bangalore.html Thu, 30 Jan 2014 17:06:00 +0530 Speaking exclusively to BioSpectrum on the occasion, Mr. Sohang Chatterjee, director & CEO of the company expressed, "Biotechnology has now become the prime instrument in conquering that final frontier of medicine-personalised therapy. Theramyt seeks to be a leader in biological drug development, to develop advanced biologics through cutting edge technology platforms that would deliver affordable and best-in-quality drug products." Ms Kavitha Iyer Rodrigues, Theramyt's cofounder and director opined, "With this GLP-compliant facility, we are committed to delivering high quality, premium customer support, and outstanding value, through innovation and continuous improvement. Our aim is to occupy a leadership position in global biotech industry with the differentiated biologics developed in our facility in Bangalore." Mr Chatterjee further added that, "In terms of operations, we have learnt a lot about building a company from our past experiences. For us exciting times are ahead. We would need the government's support, both for our R&D and product development foray. A transparent regulatory pathway, a great ecosystem of academia, investors and good science would drive Theramyt to newer horizons of unlocking value in partnerships with MNC's." According to Ms Iyer Rodrigues, the company has raised about Rs 27.5 crore investments last year from a plethora of venture capitalists including Accel Partners, Aarin Capital, IDG Ventures and Karnataka government's KITVEN (Karnataka Information Technology Venture Capital Fund). The company firstly intends to focus in the area of anti-cancer followed by rheumatoid arthritis, metabolic diseases and cardio-vascular diseases (CVD). The company's name was coined by its scientific advisory board, which is a portmanteau of the words, 'therapeutic' and 'might'. The company was officially registered in July 2013. ]]> <![CDATA[Dr Barwale gets ICAR excellence award]]> https://biospectrumindia.com/news/95/5061/dr-barwale-gets-icar-excellence-award.html https://biospectrumindia.com/news/95/5061/dr-barwale-gets-icar-excellence-award.html Thu, 30 Jan 2014 16:52:54 +0530 The Indian Council of Agricultural Research (ICAR) awarded Dr Badrinarayan Barwale, chairman, Maharashtra Hybrid Seeds Company (Mahyco) with the ICAR Excellence Award. The award acknowledged the contribution and innovation that Dr Barwale made to the Indian agriculture sector for the past five decades. The award was given away by Union minister for Agriculture and Food Processing Industry Shri Sharad Pawar. The award ceremony concluded at Baramati, Maharashtra. Keeping in mind the title of 'Father of Indian seed indusrty', ICAR, which is the prima body for agri research and education in country, conferred the Life Time Achievement Award to Dr Barwale for his outstanding innovative approaches in the agriculture sector which in turned changed the course of life of millions of farmers. This award was assessed on various indicators of performance and contribution by a panel of eminent jury members. The awards saw the like of Dr Charan Das Mahant, Union Minister of State for Agriculture and Food Processing Industry; Shri Ajit Pawar, deputy chief minister of Maharashtra; and Dr DS Ayyappan, secretary DARE and director general, ICAR, along with other leading industry experts. The award holds a greater significance not only for Dr Barwale but for Mahyco as well. Mahyco is currently basking in the glory of golden jubilee celebration period. Over the last 50 years Mahyco has been the delivering company for farmers in terms of providing cutting edge technology in agriculture sector by providing high quality seeds. Dr Barwale on being honoured with this award expressed, "It's indeed an great momentto receive the award from Mr Sharad Pawar and this award will further motivate me to strive harder to provide superior quality seeds to farmers and their by improve their future." ]]> <![CDATA[Scotland to seek collaborations at Bangalore India Bio]]> https://biospectrumindia.com/features/95/5201/scotland-to-seek-collaborations-at-bangalore-india-bio.html https://biospectrumindia.com/features/95/5201/scotland-to-seek-collaborations-at-bangalore-india-bio.html Thu, 30 Jan 2014 11:47:48 +0530 Since the last few years, the Scottish Development International (SDI) has been actively wooing Indian firms to set up their business processing operations in Scotland. BioSpectrum spoke to Ms Rooma Bussi, country manager, SDI, to get more insights. Q: What is the current scenario on collaborations between India and Scotland for life sciences sector in last one year?The collaborations have continued to happen and in fact there has been 30 percent increase for this sector over last few years. We have assisted about 116 Scottish life sciences companies to come over to India for doing business. Few known names among them are Touch Bionics that makes prosthetic hands and limbs, Omega Diagnostics which does business in the diagnostics sector, ClinTec International is a clinical research organization. Also Thistel deals with digital pens for medical fraternity to keep the record of patients. From Indian side, Piramal Healthcare is among the prominent ones that has its presence in Scotland. Piramal Healthcare's Grangemouth facility is one of a very limited number in the UK and Europe that offers integrated, single-site experience and capabilities across both conventional pharma synthesis and bioprocessing of high potency compounds - a unique combination of skill sets required for successful antibody drug conjugate (ADC) development. These compounds - antibody drug conjugates (ADCs) - combine a cancer-defeating toxin attached to a specific antibody. They represent a novel means of delivering a synthetic, potent drug to tumour cells while also limiting the drug's effect on normal noncancerous cells and are yielding positive outcomes in previously untreatable cancers. The ADCs are a special focus of Piramal's development and manufacturing facilities in Scotland. Over the period of time, there been a healthy pipeline of trade and investment. Overall the bilateral trade has increased by 15 percent and this is expected to continue for next few years. Q: What kind of opportunity exists for Indian companies in Scotland? There is a tremendous scope of partnership between two nations. Scotland has been long having the great academic and industry environment. It has been at the forefront of medical discovery. The oncology segment has great potential due to rising incidents of cancer, The expertise in therapeutic areas, universities and industry collaborations. It is set out to form an internationally recognised cluster of digital health and care technology companies that are capable of targeting global markets and attracting significant inward investment. At the moment, the pharmaceutical companies worldwide are confronting unprecedented challenges. The drying drug development pipelines are a great area of concern and regulatory hassles are also hampering the industry. Keeping that in mind, we invite the Indian companies to come over and utilize the facilities and favourable environment in Scotland. Q: How do the Scottish companies look at India? Have the regulatory framework or slumping growth rate affected their interest? Scotland's expertise is very relevant to India. Scottish companies have innovative technologies. Also, the Scottish companies continue to favour India strongly. That is visible when we speak to them and they have been rating India as third favourable destination after US and China. India despite its decrease in growth rate, has still been able to maintain its charm. Despite its decrease in growth rate, India continues to be an attractive destination. If you look at US or UK, the markets are shrinking. But at the same time, India has great potential for growth. At current 4.5-to-five percent growth rate, we are still positive. However, it is highly required that the government clarifies its regulatory policies for the investing companies. That is important because it helps the companies to take the long term decisions regarding the investments. Q: What are your specific areas of focus? What are the activities in India?We have identified medical technologies as a big market opportunity. The potential areas include digital health and medical devices that said to close to $4.4 billion dollars. As the need of the population expands, the health markets too will require new technologies. We are working with Scottish SMEs for bringing the innovative technologies. Six-to-seven big companies are already having flourishing offices here. We are involved with Association of Biotechnology Led Enterprises (ABLE) and have collaborated with Bangalore Bio in past. We have also signed a memorandum of understanding (MoU) with the Karnataka Biotechnology and Information Technology Services (KBITS) to build partnership. ]]> <![CDATA[Astrazeneca to close R&D site in Bangalore]]> https://biospectrumindia.com/news/95/3593/astrazeneca-to-close-rd-site-in-bangalore.html https://biospectrumindia.com/news/95/3593/astrazeneca-to-close-rd-site-in-bangalore.html Wed, 29 Jan 2014 19:18:00 +0530 Consequently, the company will no longer carry out early stage research in neglected tropical diseases like TB and malaria. The closure of this site will impact Astrazeneca's 168 full-time employees, who work on pharmaceutical development and drug discovery research into the neglected tropical disease. Mr Sudhir Nambiar, site head and vice president, pharmaceutical development, R&D, Astrazeneca, Bangalore, said, "We realize this is a difficult news for our research colleagues in Bangalore and our priority is to support them over the coming months. We have not taken this decision lightly. We acknowledge the excellent work carried out by our people in Bangalore. These changes reflect the company's strategic focus on investing in our core therapy areas and simplifying our R&D footprint." Pharmaceutical development projects currently carried out at the site will either transfer to its Macclesfield site in the UK, or be carried out by external providers said the company's press release. However, AstraZeneca will continue to provide expertise to help advance existing third-party neglected tropical diseases programmes for the benefit of patients. Employees affected by the changes will start leaving the company at the end of April this year. AstraZeneca's India commercial organization and clinical operations, which is also based at the Avishkar site, will move to a new location in Bangalore this year. Excerpts from an exclusive interview with Astrazeneca's senior management to BioSpectrum: What kind of impact will this decision have on Astrazeneca's business strategy? This decision is part of AstraZeneca's broader global business strategy to simplify its research and development footprint, and focus resources on three core therapy areas namely: oncology; cardiovascular, metabolic & respiratory diseases; inflammation and autoimmunity. Within that context, we have decided to consolidate the pharmaceutical development work in Macclesfield. AstraZeneca will no longer engage in early-stage research activities in neglected tropical diseases including tuberculosis and malaria; however we will continue to make our compound library available through open innovation partnerships and provide expertise that can help advance research programmes. We will continue to advance our promising early and late stage pipeline of anti-infective compounds, including our AZD5847 project, which is in Phase II development for the treatment of TB, currently led from our Boston R&D site. Why will the company ignore research in tropical diseases? AstraZeneca and the pharmaceutical industry are facing some difficult challenges and as a result we have had to make some very tough choices. How is this going to affect the employees in the company? And what are the compensation the employees are entitled to? All employees will be treated fairly and with respect, and will be provided support through this transition, in line with employees impacted at AstraZeneca's R&D sites that have closed elsewhere in the world. Can you give us more information on moving of clinical operations to Bangalore? AstraZeneca's India commercial organization and the clinical operations based at the Avishkar site will move to a new location in Bangalore later this year. Our sales and marketing group and clinical operations employees will not be impacted by this decision. ]]> <![CDATA[ICRISAT identifies 40 germplasm lines of chickpea ]]> https://biospectrumindia.com/news/95/3586/icrisat-identifies-40-germplasm-lines-of-chickpea-.html https://biospectrumindia.com/news/95/3586/icrisat-identifies-40-germplasm-lines-of-chickpea-.html Fri, 24 Jan 2014 16:47:00 +0530 In yet another significant contribution to the fight against hunger and climate change, the International Crops Research Institute for the Semi-Arid Tropics (ICRISAT) has identified 40 germplasm lines of chickpea with resistance to extreme weather conditions such as drought, high temperature and salinity. The climate resilient germplasm lines are expected to further strengthen ICRISAT's efforts to develop adaptation measures and support mitigation measures to help smallholder farmers in Asia and sub-Saharan Africa cope up with the changing climates. A diverse chickpea mini core germplasm collection consisting of 211 lines was systematically evaluated to identify beneficial traits such as high yield and drought tolerance in the 40 lines. The evaluation of this collection also helped the ICRISAT Genebank team identify 31 lines with resistance to pests and diseases. Six germplasm lines of chickpea were found to have resistance for both extreme weather and for pests and diseases. "We have been experiencing extreme weather events like the severe floods in India last year that devastated the northern states and recently, Typhoon Haiyan that ravaged the Philippines. You will see more of these extreme events which will also adversely affect agriculture. Under these circumstances, the findings by the ICRISAT Genebank team will help the smallholder farmers close crop yield gaps significantly," said Dr William Dar, director general ICRISAT. The rich and diverse germplasm resources available at the ICRISAT Genebank have been helping plant breeders in Asia and sub-Saharan Africa as sources of beneficial traits to develop new high-yielding and resilient varieties with better quality to boost production of food crops like chickpea, even under a climate change regime. The samples of seeds collected from the farmers' fields, having genes with desirable traits act as valuable materials for plant breeders in making new crosses and incorporating new unique characteristics into existing varieties. Chickpea is an important legume in the world, with a total worldwide production of 11.6 million tons from 13.2 m ha of land. India accounts for 70.7% of the world chickpea production while Australia, Turkey, Myanmar, Ethiopia, Iran and Pakistan are among other important chickpea producers. Rich in protein, starch, fiber, minerals, and vitamins, chickpea is one of the most nutritionally balanced pulses for human consumption. It is grown as a winter crop in the Indian subcontinent (October-November to March-April) on receding soil moisture, mostly on marginal soils and has the potential to feed millions of people. The latest findings are the result of a 14-year effort by the team led by Dr Hari D Upadhyaya, head of Genebank at ICRISAT, published in the paper "Mini Core Collection as a Resource to Identify New Sources of Variation" featured in the prestigious journal Crop Science by the Crop Science Society of America (CSSA). Dr Upadhyaya recently received the most prestigious Crop Science Research Award from the CSSA. ]]> <![CDATA[â€œICRISAT focusing on inclusive developmentâ€?]]> https://biospectrumindia.com/interviews/95/5616/icrisat-focusing-on-inclusive-development.html https://biospectrumindia.com/interviews/95/5616/icrisat-focusing-on-inclusive-development.html Fri, 24 Jan 2014 15:10:00 +0530 Q: How has been the incubation climate as far as agri-business focused entrepreneurs in India are concerned? 'The business incubation in agri sector is gaining momentum in India with the support provided by the Govt. of India initiatives through DST & ICAR. The International Crops Research Institute for the Semi-Arid Tropics (ICRISAT), pioneering this initiative in 2003 and having successfully run over a decade, is set as a role model for many emerging agri-business incubators. Globally this phenomenon is popular among the developed nations and with success of Indian agribusiness incubators (Network of Indian Agri-Business Incubators-NIABI), many countries in Africa have initiated similar programs. These incubators are supporting entrepreneurs with agro technologies, market research, scientific support, funding facilitation and other business related services. Q: What are objectives of innovation and partnership program initiated by ICRISAT? What have been the achievements so far and which new opportunities are you looking at? The Innovation and Partnership or INP program is one of the Public-Private Partnership (PPP) initiatives established under the aegis of Agribusiness and Innovation Platform (AIP) at ICRISAT. Established in 2007, it is set up to facilitate collaborative and partnership research for established agricultural companies / institutions with ICRISAT. The focus of INP is to develop strong collaborative R&D partnerships with public, private and allied sectors in the areas of plant breeding, agricultural biotechnology, natural resource management, knowledge sharing, and value chain development that support the small holder farmers of dry land tropics across the agricultural and agribusiness value chains. So far companies like Pioneer, D1 Oils, Nandan Biometrix, ITC, Kenes Exhibitions, DevGen, Hytech Seeds, Gubba Group have partnered with ICRISAT for their various R&D activities. ICRISAT through INP program extends partnership opportunities to corporate sector in the areas of product development, contract research, collaborative projects, innovation led business models and events in agribusiness that can benefit the farming communities on large. Q: Please tell us about AgBioAsia and its relevance in present context? ICRISAT has been partnering with the State Government of Andhra Pradesh and the Federation of Asian Biotech Associations [FABA] in organizing the State's flagship event BioAsia for many years now. This partnership continues strongly for the eleventh BioAsia also, scheduled to be organized from Feb 17-19, 2014 organized with the theme of "Harnessing the potentials of Global Nutraceutical Market" and special focus on Food, Nutrition and Health. The sector faces great challenges in terms of ensuring food security for hundreds of millions of miserably poor people, supply chain constraints and regulatory apprehensions. Recognizing the potential of India's rich, traditional and natural resources that form the basis of nutraceutical products, AgBioAsia will also focus on Health and Nutrition in order to leverage on this strength and transform the potentials into successful opportunities. Additionally, the conference will also focus on novel concepts to complement research & development in the nutraceutical sector, creating awareness, and generating social, economic and environmental benefits. Aimed at driving scientifically validated solutions, products and enterprises for the benefit of society, the event will connect the traditional knowledge to modern practices, science and technology and emerging opportunities in the area of health and wellness. Q: What is the market potential for neutraceutical products in India? What are the latest trends in this area? The global market for neutraceutical is projected at US$250 billion by 2018 largely driven by the need for a disease free lifestyle, according to a Grant Thornton study. In 2012, the Indian nutraceuticals market accounted for only about 1% of the global nutraceuticals market. Given the changing demographics of the Indian population and increasing focus on fitness and good health, the nutraceuticals market is being identified as a high potential market in India. Neutraceuticals have entered the world food market and have gained tremendous importance in the last few years in the most developed countries. While USA and Japan are leaders in the segment, India, China and Brazil promises huge potential. With the mushrooming population and the percentage of undernourished children, India is poised to overtake China and represents an extremely favourable market for the growth of nutraceuticals. Q: What are the current activities at ICRISAT and your goals for 2014? ICRISAT focuses on research and development activities for the betterment of the agricultural sector in the Semi-Arid Tropics of Africa and Asia. We envision a prosperous, food-secure and resilient dryland tropic. To achieve this, our mission is to reduce poverty, hunger, malnutrition and environmental degradation in the dryland tropics. For a long time, dryland farm families have been marginalized out of the development loop. We have adopted an inclusive (broad-based) strategy that puts them into the mainstream to participate and reap the benefits of development. Moreover, it will enable the poor, particularly women and the youth/children, to participate in the development process. We call this strategy Inclusive Market Oriented Development or IMOD. We believe that all stakeholders need to come together and work towards a positive transformation in the agricultural sector. Public-Private Partnerships (PPP) hold the key for activating the IMOD cycle in order to replicate and scale-up the benefits of technology interventions and science-based solutions for millions of smallholder farmers. One of the best ways of achieving this is to promote entrepreneurship in the agricultural sector.Entrepreneurs act as major building blocks of the economy anywhere in the world today. When it comes to the agricultural sector, however, the challenges facing entrepreneurs are many and diverse. Q So, how do we address this? Which is the best mode to promote entrepreneurship in agriculture? In 2014, we want to continue building partnerships to achieve our long term goals especially through our AIP-ICRISAT which is serving as a PPP model, furthering the mission of ICRISAT. We welcome our private sector partners to join hands with us in addressing the upcoming challenges of agriculture in the Semi-Arid Tropics. ]]> <![CDATA[Lilly aiming for top position in India by 2020]]> https://biospectrumindia.com/news/95/3583/lilly-aiming-for-top-position-in-india-by-2020.html https://biospectrumindia.com/news/95/3583/lilly-aiming-for-top-position-in-india-by-2020.html Fri, 24 Jan 2014 12:17:02 +0530 US drug major Eli Lilly and Co has announced that it is looking at introducing more products in India to become one amongst the top 20 pharmaceutical companies in the country by the year 2020. Lilly India announced that it is looking at introducing more innovation-based products across five therapeutic segments, including diabetes, over the next six years in the country. Speaking at the launch of the insulin delivery pen - Humapen Savvio, Mr Edgard A Olaizola, Managing Director, Eli Lilly and Co India told PTI, "We are committed to India and it's our aim to be among the top twenty pharma companies in India by 2020."The company is currently placed at the 47th position in terms of revenues among pharma companies in India. Mr Olaizola added that the company would be laying maximum emphasis on its diabetes portfolio and would be introducing new products to cater to over 60 million patients in the country. "We expect to launch few products to cater to diabetes patients in the next three years. It is expected that the number of patients will cross 100 million by 2030," he said. However, even though diabetes is a main part of the company's portfolio, it has presence in osteoporosis, cardiovascular, oncology and growth hormones segments. ]]> <![CDATA[Biotech can overtake IT says Sam Pitroda]]> https://biospectrumindia.com/news/95/5220/biotech-can-overtake-it-says-sam-pitroda.html https://biospectrumindia.com/news/95/5220/biotech-can-overtake-it-says-sam-pitroda.html Thu, 23 Jan 2014 18:19:00 +0530 Terming the biotechnology as being "pervasive", Mr Sam Pitroda, advisor to the prime minister on public information infrastructure and innovation, has hailed the sector as one with the capacity to emerge even bigger than information technology (IT). "With biotech, we can expedite the process of development in pharmaceuticals, environment, processes and many other things," remarked Mr Pitroda who is also the head of National Innovation Council. He was addressing the media at an event marking the launch of the first phase of a plan developed by the Biotechnology Industry Research Assistance Council (BIRAC), which aims to foster innovation and techno-entrepreneurship in Indian universities. "Biotech could be bigger than IT (information technology) in terms of export.The sector is not essentially limited to medicines but energy, agri fields and oceans. I see biotech everywhere. We have an edge if we have 200-300 highly trained scientists and no doubt that we can do wonders," Pitroda told the BioSpectrum. On being asked what the word 'innovation' meant to him, he defined the term in his own way. Explaining the same he said, "Although the word innovation has lots of meanings, it brings about change not just in terms of new products but the processes and delivery too. It is thinking just outside of box." The BIRAC initiative, in collaboration with the biotechnology industry,will leverage the University Innovation Cluster (UIC) and Cluster Innovation Centre (CIC) model recommended by the National Innovation Council (NIC). The UIC model seeks to build an innovation network with multiple stakeholders and CICs, identify and forge partnerships with institutions of interest, further facilitating the innovation culture. ]]> <![CDATA[Biocon a $1 billion enterprise by FY18: Dr Kiran Mazumdar]]> https://biospectrumindia.com/news/95/3581/biocon-a-1-billion-enterprise-by-fy18-dr-kiran-mazumdar.html https://biospectrumindia.com/news/95/3581/biocon-a-1-billion-enterprise-by-fy18-dr-kiran-mazumdar.html Thu, 23 Jan 2014 15:23:00 +0530 Biocon's CMD Dr Kiran Mazumdar-Shaw, today hosted an exclusive conference call for media fellows declaring the company's Q3 results for FY14. "We are judiciously looking at our products in the biopharmaceutical business to ensure we sustain the improved margin. Biopharmaceutical grew moderately only by 4% because during Q2 the revenues spiked largely contributed by global tenders that we won. This particular quarter didn't see much contribution from global tenders, given the fact that these tenders happens only at certain times of the year. In the next quarter, this aberration that we see will be corrected as we move ahead," opined Dr Kiran. Dr Kiran revealed that the company's R&D spend has been relatively low. "We have incurred roughly 20-21 crore R&D expense which is sharply down from our previous two quarters where we spent 40 crore and upwards. This aberration is largely of the fact that our clinical trials environment in the country which has put many of our clinical trials on hold," she added. At the same time, Dr Kiran expressed much satisfaction on clinical trials program that are making good progress in other countries. "The outlook for the next quarter looks very good and I'm confident that we'll end the year on high," she added. Commenting on the major challenges faced by the company, she said, "It is challenging in terms of increase in R&D providing growth opportunities. The real growth will only come from the following FY very largely from our insulin business as we open our Malaysian facility." Dr Kiran considers that the actual contribution from the Malaysian plant will only begin from FY16, as it will be opened during FY15. "Until then, we are trying small increment expansion, but the real exponential growth will come only when the Malaysian facility is thrown open," she further added. Currently, Biocon is carrying out several clinical trial programs in other countries which she refused to comment on. The trials are now being executed in the US and Europe. "As a result, we face an exponential increase in the cost of conducting clinical trials. This is where we are concerned. And the Indian government is just not doing anything," she expressed. Dr Kiran revealed that the company is seeing a high attrition in the sales and marketing base, which is very common. Talking to BioSpectrum on the pricing criticisms on CANMAb and Biocon's future collaborations, Dr Kiran Mazumdar added, "First and foremost we have done a great service to patients by slashing the prices. Our reference product hardly gave access to very many patients in the country. We also have come up with a 150mg presentation of CANMAb, which made the product even more affordable. We'll further still bring the price down in the future. Right now, our collaborations is with Quark Pharmaceuticals and Advaxis. We are on the lookout for more partnerships. We'll announce them as and when we collaborate." When BioSpectrum asked about addition of new modules to the Biocon Academy programs, she commented, "In the first year, we want to train at least 100 candidates, and 30 of them are already on board. We have a placement cell where we'll assist students getting placed in the industry. Right now, the modules make up the program and we'll add other programs if the need arises." CANMAb will gain registration in few other markets like Middle East, North Africa and South-East Asia. We are absolutely on track to make Biocon a $1 billion enterprise by FY18, revealed Dr Kiran. ]]> <![CDATA[Biocon to develop novel cancer immunotherapy ]]> https://biospectrumindia.com/news/95/3575/biocon-to-develop-novel-cancer-immunotherapy-.html https://biospectrumindia.com/news/95/3575/biocon-to-develop-novel-cancer-immunotherapy-.html Thu, 23 Jan 2014 12:56:01 +0530 On January 22, 2014, Biocon and US-based Advaxis, declared that they have signed an exclusive licensing agreement for the co-development and commercialization of ADXS-HPV. ADXS-HPV is a novel cancer immunotherapy for the treatment of human papillomavirus (HPV), associated with cervical cancer in women, for India and key emerging markets. Advaxis is a clinical-stage biotechnology company in New Jersey (US) involved in developing next generation cancer immunotherapies. Talking about the pact, Biocon's CMD, Dr Kiran Mazumdar-Shaw said, "Biocon is committed to finding solutions for women's health issues. This partnership will enable us to develop ADXS-HPV, a novel immunotherapy to combat cervical cancer in women. It is a promising technology that has the ability to suppress the tumor inside the micro-environment, and can be leveraged for developing several other novel therapeutics to address various unmet medical needs of patients in India and other emerging markets." According to World Health Organization (WHO), in 2008 there were over 530,000 new cases of cervical cancer worldwide, and 90% of these were reported in developing countries. Cervical cancer is one of the most frequent cancers in women in India. Over 366 million women over 15 years are at a risk of developing cervical cancer. It is estimated that every year over 134,000 women are diagnosed with cervical cancer in India, and nearly 73,000 die from this disease said the company's press release. Mr Daniel J O'Connor, CEO, Advaxis commented, "We are excited to partner with Biocon in India to bring our innovative cancer immunotherapy for cervical cancer to women with few alternatives." He further added, "This agreement gives us reach into key markets where the number of patients with HPV-associated cancers is overwhelming." Under the agreement, Advaxis will provide exclusive commercialization rights for ADXS-HPV to Biocon for India, and key emerging markets for all HPV-associated cancers. While globally there were over 300,000 deaths, the African region recorded over 50,000 deaths and Asian countries reported over 150,000 deaths for the year.ADXS-HPV has the potential to address this huge challenge in the developing world claimed the press release on Wednesday. Dr Abhijit Barve, president, R&D, Biocon, said, "The clinical data generated so far with ADXS-HPV look very encouraging in patients with advanced metastatic disease who were resistant or refractory to existing therapies. The clinical responses were comparable to prevalent chemotherapy agents and this was achieved with very low incidence of adverse events." Under the terms, Advaxis will manufacture and supply ADXS-HPV to Biocon. ]]> <![CDATA[Indian companies among emerging world's vaccine heroes: Bill Gates]]> https://biospectrumindia.com/news/95/3579/indian-companies-among-emerging-worlds-vaccine-heroes-bill-gates.html https://biospectrumindia.com/news/95/3579/indian-companies-among-emerging-worlds-vaccine-heroes-bill-gates.html Thu, 23 Jan 2014 12:54:12 +0530 The founder of Microsoft and co-chair of the Bill & Melinda Gates Foundation, who is to attend the World Economic Forum's Annual Meeting, said there is reason to be optimistic than ever about the future progress using vaccines to give all children a healthy start to life. "You have probably never heard of many of the pharmaceutical companies - Serum Institute of India, Bharat Biotech, Biological E, China National Biotech Group, and Bio-Manguinhos, to name just a few - that have become some of our most valuable partners in global health," Gates said in WEF blog. "By harnessing the same innovative spirit that transformed emerging markets into manufacturing hubs for everything... these companies have become leaders in supplying the world with high quality, low-cost vaccines," he said. The increased competition and new manufacturing approaches created by these firms have made it possible to protect a child against eight major diseases. These include tetanus, polio and tuberculosis. According to Gates, Serum Institute produces a higher volume of vaccines than any other company in the world and has played a key role in cutting costs and boosting volumes. "When the GAVI Alliance first introduced it in 2001, there was one supplier and the cost was USD 3.50 per dose. As demand for the vaccine grew, GAVI encouraged other suppliers to enter the market, and the price tumbled. Now there are five suppliers, and Biological E, an Indian pharmaceutical company, announced earlier this year that it would offer the vaccine for just USD 1.19 per dose," he said. Referring to various initiatives in emerging markets including India, Brazil and China, Gates said that India's Department of Biotechnology and Bharat Biotech announced plans this year to release a new vaccine against rotavirus - which kills hundreds of thousands of children - for USD 1 per dose. Despite all the progress, more must be done to target the 22 million children, mainly in the poorest countries, who do not have access to lifesaving vaccines, Gates said. ]]> <![CDATA[Biocon's Malaysian facility will unveil in FY15]]> https://biospectrumindia.com/news/95/5940/biocons-malaysian-facility-will-unveil-in-fy15.html https://biospectrumindia.com/news/95/5940/biocons-malaysian-facility-will-unveil-in-fy15.html Thu, 23 Jan 2014 12:16:00 +0530 According to the company's statement, Biocon's revenues touched Rs 2,187 crore, EBITDA stood at Rs 550 crore and PAT at Rs 301 crore. In her comments, Biocon's CMD Dr Kiran Mazumdar-Shaw, revealed that the company's investment efforts in building its insulin facility in Malaysia is on track and that it will be unveiled in FY15. Commenting on the occasion, Dr Kiran Mazumdar-Shaw stated, "Q3 FY14 has been a very eventful quarter for us, with several research milestones across our novel molecules and biosimilars portfolio. The key highlight was the DCGI approval for our biosimilar Trastuzumab, which paved the way for its commercial launch in India as CANMAb." CANMAb was launched in Bangalore, India, on January 18, 2014, as the world's first biosimilar Trastuzumab. According to the press release, Biocon's biopharmaceuticals segment has been steady with 14% YoY. "We have witnessed sustained business momentum in research services (35% YoY), and a return to growth for our branded formulations vertical. We expect to close this financial year with a strong performance across business verticals," expressed Dr Kiran. Dr Kiran also quoted that the company has strengthened its R&D pipeline with 2 new alliances giving access to novel technology platforms. Dr Peter Bains, director Syngene International, opined, "We are pleased with the strong growth delivered by research services through 9MFY14. This reflects sustained business momentum and an increasing penetration of our integrated service offerings." The biopharmaceuticals segment delivered a growth of 9% YoY at Constant Exchange Rate (CER) during 9M FY14. For Q3 FY14, at CER, the segment performance declined by 2% YoY. Dr Bains believes that as pharma and biopharma continue to evolve the R&D models, he sees a sustained emphasis on collaborative externalization. "In addition, there is increasing interest from allied sectors such as nutrition, consumer & animal health and agro-chemicals to create partnerships between our research and development capabilities and their product pipelines," he added. Overall, Biocon's stated that its outlook for FY14 remains positive as it strives to balance its revenue growth and R&D spend. "Our portfolio and cost optimization initiatives continue, helping us manage our margins more effectively. We continue to invest in our R&D pipeline, and the several milestones achieved over the course of this year are indicative of the growth opportunities ahead of us," said a statement. This year Biocon has strategically partnered with Quark Pharmaceuticals to develop siRNA based novel therapeutics, and Advaxis, for a novel cancer immunotherapy. The company attributes its growth for this quarter to its flagship brands Basalog, Insupen, BioMab EGFR, Abraxane and Cytosorb. ]]> <![CDATA[Indian Pharma industry marks double digit growth ]]> https://biospectrumindia.com/news/95/4807/indian-pharma-industry-marks-double-digit-growth-.html https://biospectrumindia.com/news/95/4807/indian-pharma-industry-marks-double-digit-growth-.html Thu, 23 Jan 2014 11:24:20 +0530 Pharmaceutical market showed a progressive growth of double digits for the second consecutive period in December 2013. The growth was reported to be of 11.3% at Rs 6,679 crore, as per the report published by pharma market research firm IMS health. With the monthly growth recording a double digit figure in Novemeber and December, pacing annual total (MAT) market growth for the sector illustrated significant improvement, ending at 9.9% for 2013 and almost touching the double-digit mark. In November, the pharma market registered a 13.8% growth, according to IMS statistics. Mr Kumar Hinduja, senior director, strategy planning and business development commented, "Pharma market has remained almost static during the second half of 2013, moving within a narrow range of Rs 6,700-6,900 crore. A sturdy seasonal thrust coupled with the dip during the last quarter of 2012, has helped the market recover in the last quarter of 2013, especially after the Drug Prices Control Order (DPCO) 2013 impact felt during Aug-Oct period." Therapies which are closely linked to winter related ailments, have posted strong double digit growths (such as respiratory at over 18.7 percent, pain or analgesics at over 10.1 percent), resulting in acute therapies growing faster than chronic segment, for the second consecutive month. Mr Hinduja further added that for the full year 2013, the National List of Essential Medicines (NLEM) segments which throw in about 17 per cent of the pharma market has revealed a decline of 1.1 per cent over the preceding year, rest of the market (non-NLEM segment) has grown at a healthy rate of 12.4 percent. Seasonal factor has also contributed to the healthy growth in December. For the month of December 2013, dermatological (22 per cent), respiratory (18.7 percent) anti-diabetic (18 percent) therapies have posted the highest growths. Seasonal swing during the month of December has pushed sales of acute therapies which contribute about 70 percent of the market, outperforming growth of chronic therapies (which continued to grow at healthy double digit levels). In 2013, anti-diabetics and dermatologicals were the fastest growing therapies at 19.1 percent and 17.7 per cent, while anti-infectives lagged way behind at a mere 1.1 percent. For the whole year 2013, the pharmaceutical market was reported at Rs 78,644 crore, with a growth of 9.9 percent, over the similar tenure last year. Local companies, on the other hand, have significantly out-performed multi-nationals (MNCs) throughout 2013, registering a growth of 11.4 percent compared to 6.5 percent respectively. ]]> <![CDATA[Jubilant Life Sciences launches new revamped website]]> https://biospectrumindia.com/news/95/4394/jubilant-life-sciences-launches-new-revamped-website.html https://biospectrumindia.com/news/95/4394/jubilant-life-sciences-launches-new-revamped-website.html Thu, 23 Jan 2014 10:41:00 +0530 Jubilant Life Sciences, an integrated global Pharmaceutical and Life Sciences company has announced the re-launch of their official website http://www.jubl.com/.The company with over three decades of experience has extensive relationships with some of the leading pharmaceutical and agrochemical companies and services customers in 99 countries. The new revamped website has an updated content and improved functionality for an improved user experience for its visitors. Commenting on the launch, Ms Nidhi Malik, head-marketing & communications, Jubilant Life Sciences said, "Our fully revamped corporate website acts as a unifying point of contact across Businesses, Subsidiaries and Functions. The navigation in the new website has been made simpler and now visitors will have an easy and a quick access to important information, such as our product portfolio, data pertaining to investor interests, sustainability initiatives, current openings and many more." At the new www.jubl.com, visitors can on one click receive content on R&D activities, post product queries, learn about innovation in drug discovery, and access information on Jubilant Group, stocks, quarter results and more.Jubilant with many accolades to its credit over the years, has been recognized as the 'Partner of Choice' to leading life sciences companies worldwide ]]> <![CDATA[Praj adopts new identity with its future growth strategy]]> https://biospectrumindia.com/news/95/3577/praj-adopts-new-identity-with-its-future-growth-strategy.html https://biospectrumindia.com/news/95/3577/praj-adopts-new-identity-with-its-future-growth-strategy.html Wed, 22 Jan 2014 18:06:28 +0530 Praj Industries, the global process solutions company has embarked on growth through transformation. Over the past 3 decades, Praj has transformed itself from being a single business sector company of ethanol solutions to multiple business organization, providing solutions for brewery, water & wastewater, process equipment & systems, high purity application and bio-products. "Praj has achieved market leadership globally with references in more than 60 countries worldwide. The new identity will demonstrate our multi-capabilities, a diverse and global organization driven by core values like innovation and excellence for attaining sustainability. While ethanol will continue to be a major focus in Praj's business, the introduction of water, pharma and biotech-led businesses signifies our continued push for sustainability." said Mr Pramod Chaudhari, executive chairman, Praj Industries while addressing the media. The company plans to drive growth through two focus areas - growth business and established business. The former will consist of 2nd Gen Ethanol, Water, Specialized Process Equipment and High Purity applications in Pharma, Biotech as well as niche BioProducts. The established business will see further innovations in 1st gen ethanol and brewery plants. On the 2nd Generation technology front, Praj has successfully developed a 'bolt-on' model wherein it brings down the capex of the plant by 30-40% over the earlier estimate. This will enable faster execution. Moreover, Praj is also ready with the engineering for the full scale demonstration plant announced earlier. On the growth business front, Praj has set a target of achieving 30% of revenues from water & wastewater, critical process equipment & systems and High Purity Applications, moving upto 40%. Simultaneously, Praj is taking each of these businesses through existing international network of offices as there is an exciting potential for technology led solutions in various sectors. Praj has specific offerings in zero liquid discharge solutions and for integrated solutions for hygienic sectors like pharmaceuticals, biotechnology and cosmetics. Praj is shifting its offices to the newly inaugurated Praj Tower at Hinjewadi in Pune. Meeting Green Building Standards, Praj Tower is designed along the principles of sustainability, equipped with solar powered electric supply, smart water management systems. It has incorporated several facilities for employees to work in with a higher level of collaboration and transparency. ]]> <![CDATA[Lilly and Boehringer launch re-usable insulin pen]]> https://biospectrumindia.com/news/95/3574/lilly-and-boehringer-launch-re-usable-insulin-pen.html https://biospectrumindia.com/news/95/3574/lilly-and-boehringer-launch-re-usable-insulin-pen.html Wed, 22 Jan 2014 08:37:00 +0530 Eli Lilly and Company India (Lilly) and Boehringer Ingelheim India, on January 21, 2014, announced the launch of HumaPen® SAVVIOTM, an innovative insulin delivery pen that meets the diabetics' individual need. Engineered to resemble a small personal accessory rather than a medical device, this latest innovation was designed following feedback from people with diabetes who shared their aspiration to manage diabetes discreetly. HumaPen®SAVVIOTM, an invention by Lilly, offers an extended shelf life of up to 6 years after first use. Announcing the launch, Mr Edgard Olaizola, managing director, Eli Lilly and Company India said "The launch of HumaPen® SAVVIOTM marks an important milestone for Lilly, reflecting our ongoing commitment to develop 'people-led' innovative solutions for diabetes. At Lilly, we recognize that people are unique and that their insulin delivery devices should reflect their lifestyle and personality. That's why we developed HumaPen® SAVVIOTM to be lightweight, portable and available in a choice of colors. It will help to bring a greater sense of normalcy to using insulin." HumaPen®SAVVIOTM, an original research product of Lilly will be co-promoted by the Lilly-Boehringer Ingelheim alliance in India.HumaPen® SAVVIOTM to be available in India across 6 metros (Delhi, Mumbai, Kolkata, Chennai, Hyderabad and Bangalore. HumaPen® SAVVIOTM re-usable insulin pen's features: â€¢ Accurate and Durable. Extended shelf life of up to 6 years after first use â€¢ Attractive, stylish, sleek & discreetâ€¢ Easy cartridge changing with twist lock cartridge holderâ€¢ Audible click sound with every unit dialed and dispensedâ€¢ Injects 1-60 units of insulinâ€¢ Insufficient remaining dose feature that doesn't allow the user to dial more than the units remaining in the cartridge Insulin therapy is an important part of diabetes management. In fact, early introduction of insulin can lower diabetes-related complications but patients are often reluctant to begin insulin therapy despite evidence of its efficacy. The new HumaPen® SAVVIOTM is short in size, lightweight, dependable, durable, easy to use insulin pen that will improve the everyday lives of people with diabetes. To boost the personal confidence of diabetics, the device is designed similar to a fashionable, compact pen with durable design and will be available in a range of colors - red, graphite, green and silver. HumaPen® SAVVIOTM also makes dosing easy and insulin delivery discreet, which helps insulin users feel more at ease when using their medication. Commenting on the launch, Mr Sharad Tyagi, managing director, Boehringer Ingelheim India said, "HumaPen® SavvioTM is in line with alliance's ongoing commitment to provide innovative solutions for diabetes treatment. We are constantly working towards pioneering interventions by leveraging scientific know-how and commercial capabilities of both companies and expanding our product portfolio for diabetes in India." As per a patient perception study conducted in July 2013*, Lilly found that the most valued features of an insulin delivery device are ease of operation, convenience of use, accurate dosing, portability and easy dialing. The study group perceived HumaPen® SAVVIOTM as better than other delivery devices available in market on most parameters including, ease of use, insufficient remaining dosage feature, stylish, sleek and discreet design being the differentiator. Diabetes continues to be a serious health issue in India; current estimates indicate that 63 million adults in India suffer from diabetes. Diabetes is a chronic, debilitating and costly disease which poses severe risks for families; there is an urgent need to pursue multilateral efforts to create awareness on prevention, diagnosis and its effective management and treatment. With a focus on reducing complications related to the disease it is necessary to address common barriers to insulin therapy initiation. HumaPen® SAVVIOTM is supported by Lilly's Diabetes Educators Service. Spread across the country, Diabetes Educators provide education/counselling on diabetes, nutrition, self-management, lifestyle management, hypoglycemia and appropriate use of injectable devices under the guidance of treating physicians.HumaPen® SAVVIOTM will be available in India across 6 metros (Delhi, Mumbai, Kolkata, Chennai, Hyderabad and Bangalore) for use with 3 mL insulin cartridges Humalog®, Humalog® Mix25 and Humalog® Mix50 on doctor's prescription. ]]> <![CDATA[Virtus health services enters Indian market ]]> https://biospectrumindia.com/news/95/2968/virtus-health-services-enters-indian-market-.html https://biospectrumindia.com/news/95/2968/virtus-health-services-enters-indian-market-.html Tue, 21 Jan 2014 15:00:02 +0530 Virtus Health Services India Private Limited (VHSI), a specialist medical technology products and services company, today announced its entry into the Indian Health Care Services market. In its first year of operations, VHSI plans to introduce oral cancer screening and digitally supported diagnostic second opinion. The fast-growing Indian healthcare services market is estimated at US $70 billion and VHSI intends to grow its business by delivering a superior customer experience. Mr Sunil Ikhe, operations director & country head, VHSI said, "India's health care services demand is grossly underserviced, considering the international standards. They can be matched, given various advances in technology. These technologies, that are now standard in advance countries globally, have been proven to create higher efficiencies and promptness of delivery across the patient support cycle, right from screening for an early detection to diagnosis, enabling long term disease or disability management and treatment. VHSI uniquely aims to bridge these gaps by introducing world class cutting edge technology-driven health care products and services to India. The healthcare industry in India is estimated to grow to US $280 billion by 2020 as per the Equentis Capital Report. The high growth in demand for health care services is being driven by higher disposable income, rapid increase in lifestyle diseases, greater consumer health consciousness and growth in medical tourism and a changing regulatory landscape. As a company, we are committed to empower Indian population with access to the best healthcare technologies to enhance their ability to make responsible choices for personal health and healthy life. Mr Ikhe further added, "In our first year of operations in India, cancer screening will be a key focus. Our first initiative in this area focuses on screening for an early oral cancer detection, given that India is the World's capital for oral cancer. The National Institute of Health and Family Welfare (NIHFW) reports that India accounts for 86% of all oral cancer cases globally. While this is one of the easier to treated forms of cancer and not fatal if detected early, about 60% of cases are diagnosed at highly advanced stages due to low awareness and availability of supporting diagnostic technology. At this time over 23% of all recorded cancer deaths in India are from oral cancer." ]]> <![CDATA[Elections in sight, can we really expect policy makeover on GEAC, GM crops?]]> https://biospectrumindia.com/features/95/7535/elections-in-sight-can-we-really-expect-policy-makeover-on-geac-gm-crops.html https://biospectrumindia.com/features/95/7535/elections-in-sight-can-we-really-expect-policy-makeover-on-geac-gm-crops.html Tue, 21 Jan 2014 13:27:00 +0530 The change of guard in the environment ministry might turn out to be no ordinary event. It is being reported that the prime minister who was vocal about the science being on priority than unchecked activism, has finally taken a call on the GM crops. Going by that India's newly appointed minister for environment, Veerappa Moily is expected to take a technology/industry friendly stand. His ministry alongwith argriculture minsitry might very soon file a joint affidavit in the Supreme Court of India to allow the GM crop trials in confined zones. The requirement of no objection certificate from states too might be done away with. It is important to note that the previous ministers, Ms Jyanthi Natrajan (predecessor) and Mr Jairam Ramesh despite being petitioned on numeruous occasions, had shied away from taking any industry friendly measure. The Genetic Engineering Apprisal Commitee (GEAC) that hasn't met since last two years (except a meeting in April, 2013 where the key members were missing and even the minutes were not made public), is expected to soon come back to table to deliberate and discuss the fate of the piled up files seeking approvals. The sources told BioSpectrum that the approvals to atleast about 35-40 products on priority basis might happen soon. Earlier, the Maharashtra government in December, 2013 granted NOCs to 28 applications from seven companies for confined" field trials. Despite the opposition from within the stste government, the chief minister of the state decided to give the nod on case to case basis. The NOCs have been granted to transgenic varieties of rice, wheat, maize, brinjal and cotton. The companies granted clearances include Monsanto India, Mahyco, Bayer Bio Science, Syngenta Bio Sciences, Pioneer Overseas Corporation, Dow Agro Sciences India and Ankur Seeds. The government's Central Institute for Cotton Research has also been given an NOC. The move has recieved all the support from union agriculture ministry. Meanwhile Ms Aruna Rodrigues, an anti-GM activist whose PIL in the supreme court is under hearing, was quoted as saying that the prime minister has an agenda to foster biotechnology with United State support. "If the prime minister has overruled Jayanthi Natarajan and appointed a new environment minister to do his bidding, then science goes out of the window," she mentioned in herstatement to media. The anti-GM activists are expected to oppose any such move both in courts and on streets. With the parliament set to meet in February, 2014 for the last time, it remains interesting to see how things turn out for the crucial BRAI bill and the GEAC. ]]> <![CDATA[Cipla appoints Mr Sameer Goel as country head ]]> https://biospectrumindia.com/news/95/5030/cipla-appoints-mr-sameer-goel-as-country-head-.html https://biospectrumindia.com/news/95/5030/cipla-appoints-mr-sameer-goel-as-country-head-.html Tue, 21 Jan 2014 12:52:00 +0530 Cipla, announces Mr Sameer Goel as country head - India, effective from 20 January 2014. Mr Goel comes to Cipla with rich professional experience of over 26 years with GlaxoSmithKline. In his last assignment, he has led a $0.4 bn business, based out of Johannesburg, with responsibility for 44 markets in Sub-Saharan Africa. He was responsible for managing the full P&L in these markets with regional hubs and multiple manufacturing sites across South Africa, Nigeria and Kenya. He established Africa as a new "region" for the company, and has worked closely alongside the pharma business to establish a leadership position in this key emerging market. Mr Goel said, "Cipla has been a pioneer in the healthcare industry ensuring access to high quality and affordable medicines, thus being a support apparatus for millions of patients across the world. My first interaction with the Cipla management has been quite a memorable experience that has given me reassurance and a sense of comfort. It will be a great privilege and honor for me to be a part of the Cipla team and I look forward to an exciting journey that lies ahead of us." Mr Goel played a significant role in driving the entry strategy and growth agenda across a spectrum of new and established markets. He had initiated the sales and marketing route for Indian market, where he combined sales management experience in progressively larger territories, with marketing leadership roles. In his last India-based role, he led the sales function comprising a team of direct and indirect field force of 4500. He has driven a number of initiatives including expert marketing, professional detailing force, key account management, customer marketing, rural drive, and computerization of the distributors which won several global awards for the GSK team. Speaking of the appointment, managing director and global CEO Mr Subhanu Saxena said, "Sameer brings a keen sensibility and understanding of the India market, and drivers for success in this market. This, combined with his strong reputation for managing teams for stakeholders - both external and internal - makes him well placed to lead our India business into its next level of growth." Mr Goel holds a graduation degree in Economics from St.Stephenâ€Ÿs College, New Delhi, and has an MBA from the Indian Institute of Management, Ahmedabad. ]]> <![CDATA[First ever insulin injection week in India]]> https://biospectrumindia.com/news/95/7359/first-ever-insulin-injection-week-in-india.html https://biospectrumindia.com/news/95/7359/first-ever-insulin-injection-week-in-india.html Tue, 21 Jan 2014 12:43:40 +0530 Observing the insulin injection week in India from 11th January-18th January, the Forum for Injection Technique (FIT) India and Association of Diabetes Educators today announced injection recommendations for elderly people living with diabetes in the city. Dr (Prof) Hemraj Chandalia, endocrinologist, Jaslok Hospital and Research Centre, Mumbai & chairman, Association of Diabetes Educators said, "Insulin remains a critical component of treatment of Diabetes, not only type I but also in many cases of Type II. At present injection remains the only practical means to deliver insulin. It is a welcome move that a day has been dedicated to deliberate on Insulin Injection by FIT. This should have a favorable impact on the acceptance of insulin injection among both physicians and patients." The FIT recommendations suggest that physicians should not use age as an excuse to avoid usage of insulin which can delay the treatment and result in further complications. Along with insulin initiation for elderly patients, health-care providers must ensure the involvement of responsible family members/attendants during the selection of insulin and explanation of injection technique. According to Mr Salome Benjamin, member, Association of Diabetes Educators, "Most doctors start insulin therapy too late or patients accept it with difficulty. As per latest survey, not more than 30% of diabetic patients in the city are on insulin therapy. Almost half of the patients do not know about right injection techniques specially the importance of rotating injection sites." Several factors, including method of administration, dosing, compliance, selection of injection site, depth of the injection, time lapse before withdrawing the needle and misconceptions about insulin therapy, influence the success of insulin injection therapy. "About 50% of people have psychological resistance to even initiate an insulin therapy, despite it being indispensible for glycemic control to manage the disease. The recommendations by FIT India have been immensely helpful in optimizing insulin injection technique for both healthcare workers and patients and have improved the overall acceptance of insulin delivery and injections", said Dr. Chandalia. In November 2012 Forum for Injection Techniques (FIT) and BD India had come together to launch the first Indian clinical recommendations for best practices in insulin injection techniques in India. ]]> <![CDATA[India's deputy drug controller held for bribe]]> https://biospectrumindia.com/news/95/7932/indias-deputy-drug-controller-held-for-bribe.html https://biospectrumindia.com/news/95/7932/indias-deputy-drug-controller-held-for-bribe.html Tue, 21 Jan 2014 10:39:20 +0530 India's top investigation agency, the Central Bureau of Investigation has trapped the Deputy Drugs Controller of the country, Mr A Chandrasekhara Rao in a bribery scandal. Reports revealed that Mr Rao was caught accepting a bribe of Rs 50,000 as part payment of the Rs 4 lakh total bribe. Mr Rao, who also heads the Hyderabad Zone of the Central Drugs Standard Control Organization is said to have demanded the bribe to extend the licence of Janani Voluntary Blood Bank, which operates in Secunderabad and Kukatpally. Top CBI personnel conducted the search of Deputy Drugs Controller's house and seized Rs 26 lakh in cash, gold ornaments, and property documents that are being verified to find out whether they are disproportionate to his known sources of income. Ms Laxmi Reddy, the CEO and president of the blood bank is said to have filed a complaint against this with the investigating agency. She was told to put the cash in a cover, which Mr Rao slipped into a drawer just as the agency sleuths entered his office and caught him. CBI is now said to be verifying another written complaint by a pharmaceutical company against the Deputy Drug Controller. Reports specified that a locker in his house is yet to be opened. Mr Chandrasekhara Rao has been arrested under the Prevention of Corruption Act. ]]> <![CDATA[First Indian booklet on best practice in IFT released]]> https://biospectrumindia.com/news/95/1370/first-indian-booklet-on-best-practice-in-ift-released.html https://biospectrumindia.com/news/95/1370/first-indian-booklet-on-best-practice-in-ift-released.html Mon, 20 Jan 2014 15:38:00 +0530 In an attempt to alleviate fear and increase awareness among people, the Forum for Injection Techniques (IFT), India, and Bangalore Diabetes Club jointly launched the first Indian recommendations for best practices in Insulin Injection Technique. The booklet containing evidence-based information on best practices on injection techniques was released by Dr C Munichoodappa, consultant diabetologist, Bangalore Diabetes Hospital; Dr K M Prasanna Kumar, endocrinologist and diabetologist, Center for Diabetes and Endocrine Care (CDEC); and Dr Syed Javaz, diabetologist and trustee of Bangalore Diabetes Hospital. Speaking on the occasion, Dr Munichoodappa explained that patients can inject insulin at specific places in their bodies. "The ideal place to inject insulin would be in the abdominal wall or in the hips or thighs. However, some patients tend to inject insulin in their legs and hands, which is not very advisable," he added. He also mentioned that continuously injecting insulin in the same area would bolster fat accumulation resulting in poor absorption of insulin. Generally, patients show more aversion towards injectable insulin and tend to depend on insulin tablets alone. However after a few years, the pancreas, which produces the body insulin, becomes weaker and weaker and may not respond to the tablets. "Ultimately, patients need to accept the existing injectable insulin. They consider it to be a difficult and painful process saying that they are too old or too sick to take it," said Dr Munichoodappa. Dr Prasanna Kumar believes that knowledge of insulin injection need to be spread to the common man. "This message has to be disseminated to families, doctors, nurses, diabetes educators and patients. They should know how to advice patients, thereby facilitating them to take the insulin injection. It is less painful than a mosquito bite," opined Dr Kumar. He further said that there is a lot of misconceptions about insulin. He said, "Taking insulin is not a bad thing. Insulin maybe much better than other medicines which we prescribe. Many people think that insulin is costly and tablets are cheaper. However, insulin is much cheaper and far better." Diabetes is no longer rich people's disease. He expressed, "People in slums and villages have diabetes today because of the change in lifestyle and decreasing physical activity. Diabetes in children, elderly and pregnant women is increasing." Dr Kumar advised patients with diabetes to have a disciplined diet, regular exercise and medications, and check the blood sugar level often. "If not, it is a fatalistic attitude," he concluded. ]]> <![CDATA[President launches pulse polio immunisation program 2014 ]]> https://biospectrumindia.com/news/95/5800/president-launches-pulse-polio-immunisation-program-2014-.html https://biospectrumindia.com/news/95/5800/president-launches-pulse-polio-immunisation-program-2014-.html Sat, 18 Jan 2014 17:04:00 +0530 The President of India, Mr Pranab Mukherjee launched the Pulse Polio Immunization program 2014 at the Rashtrapti Bhavan, today in the presence of the Union Health Minister, Mr Ghulam Nabi Azad and MoS (Health), Smt. Santosh Chowdhary. Six small children were administered polio vaccine by the President of India. Azad pointed out that in this round more than 17 crore children will be vaccinated. Also, 23 lakh frontline workers and volunteers will fan out in every nook and corner of the country to reach every child up to five years of age so that we maintain high immunity of our children against the polio virus. Besides setting up 102 polio vaccination posts along international borders, it has been decided that any case of wild polio shall be treated as public health emergency, the Health Minister added. Sh Azad, addressing the gathering, stated that India has not recorded even a single case of wild polio in the last three years, which is a historic achievement. Narrating the journey India took to arrive to this feat, he said that as poliovirus transmission in some parts of the country was intense, experts believed that India was the most difficult place in the world to stop polio. India however, accepted the challenge, he pointed out. In 2010, India launched bivalent oral polio vaccine with the President of India administering the first drops of the new vaccine to the children. Intense effort results in covering all children, no matter where they were. This also saw the lakhs of vaccinators braving difficult conditions to reach children in the remotest parts of the country, the Health Minister stated. The Health Minister stated that the program had the immense support of the religious and opinion leaders as well as social mobilizers who won over resistance through effective communication of benefits of polio vaccination. Community ownership of the program was fostered. The managers carefully mapped high risk habitations, particularly mobile and migrant populations, so that all under-served populations were reached, the Minister pointed out. He added, that this required close monitoring and door to door vaccination so that no household was missed. Children were immunized on trains, in buses, in melas, in religious congregations and along the international borders. This was done again and again with never-say- die spirit, Sh Azad added. This resulted in coverage rates of unprecedented levels. The Health Minister noted that the response to the last polio case in Howrah in West Bengal was razor sharp and is globally cited as the fastest response time. The Ministry stepped up surveillance so as not to miss even a single case of polio, he added. Sh Azad stated that from a position when India had more than 2 lakh children getting crippled by polio each year, we have come to a time in history where not a single child has suffered wild polio for the last three years. This is monumental victory- and has paved the way for India`s formal certification by WHO as a polio free nation, he informed. He thanked various partners such as the State governments, lakhs of supervisor and vaccinators, volunteers, WHO, UNICEF, Rotary International, World Bank, USAID, DFID and many more who have made this achievement possible. Also present at the occasion were senior officials from the Ministry of Health and Family Welfare, representatives from international partners such as WHO and DFID and media. ]]> <![CDATA[Ranbaxy again under USFDA scanner, Stocks too take a dip]]> https://biospectrumindia.com/news/95/3430/ranbaxy-again-under-usfda-scanner-stocks-too-take-a-dip.html https://biospectrumindia.com/news/95/3430/ranbaxy-again-under-usfda-scanner-stocks-too-take-a-dip.html Sat, 18 Jan 2014 16:18:00 +0530 At times when the company was trying its best to get back on track, the new year has brought a bad news for Ranbaxy. It received the form 483's with certain observations as a result of the recent US FDA inspection at its API plant at Toansa, Punjab, India. According to the Management, it's assessing the observations, and will respond to the US FDA in accordance with the agency's procedure to resolve the concerns at the earliest. While the Management has not indicated, the plant is said to manufacture around 70-75% of its API requirements. Meanwhile the news had its effect on stock market too. The company's stocks dipped 4% to Rs 400 immediately after the news broke. However, now the company has gained a bit from there but is still down by 2.42% to Rs 406. The same will be now followed closely by the shareholders and industry alike. An FDA Form 483 is issued to firm management at the conclusion of an inspection when an investigator(s) has observed any conditions that in their judgment may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts. The FDA Form 483 notifies the company's management of objectionable conditions. At the conclusion of an inspection, the FDA Form 483 is presented and discussed with the company's senior management. Companies are encouraged to respond to the FDA Form 483 in writing with their corrective action plan and then implement that corrective action plan expeditiously, otherwise could lead to the import alert. Ranbaxy Lab's other key facilities in India, i.e at Ponta Sahib (Himachal Pradesh) and Dewas (Madhya Pradesh), have been under an US import alert since 2008. During the 2QCY2013, its other key facility Mohali also came under USFDA import alert. With this plant Toansa (Punjab) , also under scanner, it would have impact on the operations of the company in US, unless it can compensate for the same at the earliest and mange a smooth supply of key raw material. ]]> <![CDATA[Biocon launches world's first Biosimilar 'CANMAb' in India]]> https://biospectrumindia.com/news/95/3457/biocon-launches-worlds-first-biosimilar-canmab-in-india.html https://biospectrumindia.com/news/95/3457/biocon-launches-worlds-first-biosimilar-canmab-in-india.html Sat, 18 Jan 2014 14:56:00 +0530 CANMAb has been jointly developed by Biocon in partnership with Mylan and it is said to be the world's first biosimilar version of Herceptin. At the launch this morning, Dr Kiran said, "We are announcing the launch of a very important product that we have developed over the years. We have branded this product as CANMAb, which is all about Convenience, Affordability and something New from India." After 7 years of painstaking research and development, CANMAb is exclusively manufactured at Biocon's biologics facility in Bangalore and will be available for patients during the first week of February 2014. CANMAb will be available in 150mg and 450mg quantities, priced at Rs 19,500 and Rs 57,500 per vial respectively, compared to Herceptin, which costs Rs 75,000 for 440mg. Breast cancer is the most common cancer among women across India and the world. The incidence of breast cancer in the world is roughly about 1.6 million cases reported each year. About 1.4 lakh cases of breast cancer are reported in India annually and 25% of then are HER2-positive. HER2-positive is said to be aggressive and fast-growing breast cancer, which has much higher risk of early recurrence and death. The launch saw the presence of Biocon's key management team including, Dr Arun Chandavarkar, COO; Mr Shukrit Sudhir Chimote, India head & VP, branded formulations; and Dr Abhijit Barve, president, R&D. Dr Kiran revealed that more than 80% of the deaths due to non-communicable diseases (NCD's) occur in the developing countries and cancer is one among them. "Most drug innovation takes place in the developed world. What is also important is that only 1 out of every 4 new molecular entities is made available in the developing markets. This is a major challenge that we face," she added. Dr Kiran spoke about the affordability challenge that is being faced in the developing economy. She said that unlike the developing world, the developed world has a very good coverage of health requirements through national health care systems. "Even though drugs are made available to the developing economies, it is still beyond the reach of many patients in the developing economies," opined Dr Kiran. According to Dr Kiran, 45% of the families with one cancer patient face catastrophic expenditure in India. About 25% of the families with one cancer patient are pushed below the poverty line. The cost of treatment for metastatic breast cancer patient in India is about Rs 20,000-30,000 per month, and it is Rs 80,000 per month for treating HER2-positive using innovator trastuzumab. In her presentation, Dr Kiran pointed out that in Europe, a patient has to spend just about 0.5 days of his wages for the purpose of OAD treatment course, compared to south-east Asians who need to spend 1.3 days of their wages and African's up to 8.4 days of their wages. She also presented that, in Europe a patient has to spend approximately 143 days of his or her wages to purchase a cancer metastatic treatment course; 372 days wages in south-east Asia; 1285 days wages in Latin & South America; and 2398 days' worth wages in Africa. "A lot of middle income countries face the 5/80 cancer disequilibrium. 95% of the global spending on cancer drugs is in high-income countries. Only about 5% is spent in developing economy and yet the burden of diseases is only in the developing economy. In south-east Asia, the per capita income is roughly about $3000 and the treatment for leukemia is about $20,000. Here we can see how skewed this whole cancer treatment regime is," added Dr Kiran. In 2010, there were about under a million cancer cases reported in India. But this may rise to 1.2 million by 2020. Today, India stands next to US and China in this regard. In the past, cancer was treated through radiation and chemotherapies, but now it is more of using targeted therapies like biologics. "Biologics are very expensive drugs to be developed. They are complex, and in the US, biologics cost anywhere between $100,000-500,000 per year. This is absolutely unaffordable in a country like India. This made us believe to develop a drug in terms of biosimilar," explained Dr Kiran. To develop a biosimilar, it take about 50 times the cost and 4 times the time in comparison to developing small molecule generics. In her concluding remarks, Dr Kiran Mazumdar expressed, "We have now developed this important biosimilar. We hope to take this drug to patients who need it. We focus on making it very accessible to patients beyond just providing drugs at lower cost. We will have a special program for compassionate use at discounted schemes for the poor. We hope it will really impact patients suffering from HER-2 positive breast cancer." The clinical trials (CANMAb Vs Herceptin) were carried in 23 centers across India for a duration of 24 weeks. Dr Arun Chandavarkar added, "We started working on this drug before partnering with Mylan back in 2007/08. It took us a lot more time and money, and a significant investment to bring this biologic product to the market simply because it is a complex molecule that is difficult to develop, requiring elaborate clinical trials unlike small molecule generics." So far, Biocon and Mylan has co-developed 8 molecules in partnership. ]]> <![CDATA[Abbott receives Golden Peacock Innovation Management Award]]> https://biospectrumindia.com/news/95/3561/abbott-receives-golden-peacock-innovation-management-award.html https://biospectrumindia.com/news/95/3561/abbott-receives-golden-peacock-innovation-management-award.html Fri, 17 Jan 2014 16:03:46 +0530 The Golden Peacock Innovation Management Award honors organizations that have successfully embedded innovation into the basic tenets of their corporate cultures demonstrated in every function of the business and its operations. The Award aims to promote a 'culture of innovation' in India and recognizes the efforts of companies that work toward strengthening this goal. Abbott in India received the award in recognition of the company's strong scientific heritage and leadership in innovation, commitment to an approach that caters to patients' evolving needs, and its focus on institutionalized innovation. "With over 12,000 employees in India, Abbott is committed to delivering healthcare solutions that are relevant to patients and consumers while providing value to physicians through our dedication to innovation in medicine, nutrition, devices, diagnostics and our overall business," said Mr Bhasker Iyer, divisional vice president, Established Pharmaceuticals, Abbott India. "Abbott's success in driving its innovation agenda is deeply rooted in a philosophy that focuses on achieving results effectively and impactfully for the people of India," he further added. ]]> <![CDATA[2014 holds new promise for India]]> https://biospectrumindia.com/features/95/5931/2014-holds-new-promise-for-india.html https://biospectrumindia.com/features/95/5931/2014-holds-new-promise-for-india.html Fri, 17 Jan 2014 15:58:13 +0530 The year 2013 was probably one-of-the-worst years for the Indian economy as economic growth decelerated to below five percent and inflation soared. Political bickering and scandals kept the government in fire-fighting mode, leading to a stalling of much-needed economic reforms and policy paralysis. The extent of the government's failure was reflected in the skyrocketing prices of onions, despite India being the world's second-largest producer of onions after China. In order to manage this manmade crisis the Indian government was compelled to import onions from neighboring countries. It is no wonder then that elections in India are fought over rise and fall of 'vegetable prices.' Trouble for pharma industry India's pharma sector also witnessed an unprecedented slowdown, growing at barely 5.20 % in 2013 against an average growth of 12 percent the previous year. The negative impact was further compounded by adverse policy decisions in India with respect to a new drug price control regime, a moratorium on clinical trials, uncertainty trol regime, a moratorium on clinical trials, uncertainty over the FDI policy and attempts to invoke frivolous compulsory licenses on several drugs.An overactive US FDA did not help matters, as it hauled up several leading Indian pharma companies for non-compliance. All these negative developments collectively turned 2013 into an Annus Horribilis for the Indian pharma sector. The good news It was not all gloom and doom. On the brighter side, India took the lead in developing and adopting biosimilars guidelines, which enabled the approval of the world's first biosimilar of Herceptin for breast cancer, developed in India by Biocon and Mylan.The introduction of biosimilar Trastuzumab in India in 2014 will offer an affordable option for millions of cancer patients in India and in the other world markets subsequently. What to expect in 2014? As 2014 is an election year, we can expect the general elections to lead to a stable majority government at the Center. Hopefully, that will be a starting point for addressing some of the country's long-pending challenges through bold policy reforms.We hope that the new government will be able to create real jobs, pro- vide good infrastructure for industrial growth, facilitate ease of doing business in the country, ensure safety and security for women and promote better governance.At the same time, the government will need to come up with innovative solutions to meet the burgeoning healthcare needs of the country's teeming millions through affordable medicines. One of the ways to do this is to define a smarter regulatory pathway. Indian regulators can ensure improved access to affordable drugs by ensuring that local regulatory requirements don't add to the cost of drug innovation and force innovator companies to price their products at a premium. Indian companies, on their part, will need to take swift corrective action to address issues of non-compliance with globally accepted manufacturing norms and regain their reputation as quality producers of afford- able generics for global markets.The industry now needs to ensure that it has rigorous processes for self- audit to ensure zero tolerance to non- compliance. The new pharma pricing policy has led to a lot of confusion in the market with the result that some drugs have become unavailable, hurting patients. Hopefully, 2014 will see the current issues being ironed out and patients ultimately benefiting from the transition to the new pricing regime.However, the government can't expect the industry to bear the full bur- den of making medicines affordable, while abdicating its responsibility to- wards public health. The government should speedily come out with a pol- icy for universal healthcare coverage to address the needs of the poor. If India wants access to cutting-edge pharma products from overseas in- novators it is imperative that clinical trials are conducted to find their suit- ability for the Indian population. Therefore, the Indian government and courts should tackle the issue of clinical trials with a rational un- derstanding of the benefits and with greater compassion for those suffering for want of effective medicines. For Biocon, 2014 holds good promise as we bring the world's first biosimilar Trastuzumab to cancer patients in India, our novel biologic Alzumab makes a positive impact on the lives of thousands of psoriasis patients, our Malaysia plant nears completion and all our business verticals continue to report robust growth.Year 2014, can be a year of positive change if every citizen of India commits to engage with the political process, plays the role of a responsible citizen and demands good governance. Citizen participation is critical for creating an economically strong India that can gain global recognition. ]]> <![CDATA[Dr Reddy's and Galena Biopharma announce strategic partnership]]> https://biospectrumindia.com/news/95/3566/dr-reddys-and-galena-biopharma-announce-strategic-partnership.html https://biospectrumindia.com/news/95/3566/dr-reddys-and-galena-biopharma-announce-strategic-partnership.html Fri, 17 Jan 2014 14:48:42 +0530 Dr Reddy's Laboratories and Galena Biopharma announced a strategic partnership to develop and commercialize NeuVax (nelipepimut-S) in India. NeuVax is a vaccine aimed at preventing the recurrence of breast cancer in patients under remission. Under the terms of the agreement Galena will license commercial rights of NeuVax to Dr Reddy's for breast and gastric cancers. Dr Reddy's will lead the development of NeuVax in Gastric Cancer, and help significantly expand the scope of therapy by addressing a new patient population. "This partnership with Dr Reddy's is consistent with our strategy to expand the clinical utility of NeuVax in unmet medical needs while simultaneously increasing the commercial footprint of this innovative cancer immunotherapy," said Mr Mark J Ahn, president and CEO of Galena Biopharma. Galena will receive development and sales milestones, as well as double-digit royalties on net sales. The licensing and development terms are conditioned to an agreement on ancillary activities. "NeuVax promises to meet significant unmet need in Breast Cancer and Gastric Cancer patients especially due to late diagnosis for majority of the patients in India and therefore may have high probability of relapse of the disease" said Mr Alok Sonig, senior vice president and head of India Business (Generics). "NeuVax potentially will reduce the risk of relapse significantly as demonstrated in successful phase 2 trials" he added. ]]> <![CDATA[ India celebrates three years without Polio]]> https://biospectrumindia.com/news/95/7579/-india-celebrates-three-years-without-polio.html https://biospectrumindia.com/news/95/7579/-india-celebrates-three-years-without-polio.html Thu, 16 Jan 2014 15:51:00 +0530 India in celebration as the nation defeats crippling disease Polio. India completed three consecutive years without a single case of wild Polio virus, today and hence achieving the three-year milestone necessary to achieve Polio-free certification from WHO. Commemorating the day on January 13, 2014, Rotary International illuminated India's iconic monuments and buildings, all across the nation. In the capital city, the historic India Gate and Red Fort was lit up with 'Celebrating 3 Years of last Polio case in India' message. Other illumination sites in the country included the Air India in Mumbai, Hyderabad Public School in Hyderabad, Red Fort in Agra, Teeli Wali Masjid in Lucknow, Junagarh Fort in Bikaner, Sojati Gate in Jodhpour and other equally important sites in cities and towns across the country were lit-up with the message 'Celebrating 3 Years of last Polio case in India'. The three-year milestone was celebrated with much fanfare by countrymen across the country. The country reported the last polio case in Howrah, West Bengal, on January 13, 2011. Members of Rotary International, one of the spearheading partners in the Global Polio Eradication Initiative (GPEI), have been working for years to sensitize and motivate people to get their children vaccinated against Polio. Rotary's India National PolioPlus Committee Chair Mr. Deepak Kapur observing the special day said "It is a huge victory for India and its people. From being one of the most Polio infested regions a couple of years ago to completely containing Polio toward becoming Polio-free, the campaign in India has come a long way". He said that the collective effort of Polio partners spearheaded by the Govt. of India, made the difference and "We are hopeful, the partnership will ensure India remains Polio-free forever". India will be officially certified as a Polio Free nation with the certification by WHO for the entire Southeast Asia region (WHO SEAR) as a Polio free Zone. Rotary leader Mr. Ashok Mahajan the Chief Coordinator of this illumination project for Rotary India said "By lighting these historic landmarks, we want to reinforce Rotary's pledge of a Polio-free India and a Polio-free world. We would continue our battle against Polio till the last wild Polio virus is defeated all across the world". Globally only 3 countries are still endemic with polio, namely, Pakistan, Afghanistan and Nigeria. "There is a constant fear of polio virus importation from neighboring endemic countries. Therefore, we cannot afford to be relaxed till the time Polio is eradicated globally and will have to continue our efforts of protecting our children against Polio, till the world is certified Polio-free", observed Mr. Raja Saboo, Past President (global) of Rotary International. Rotary Governor for District 3010 Mr. Vinod Bansal said, "Rotary members across the country are motivated and encouraged by the India success against Polio. They will endevaour, as has been Rotary's motto, 'service before self' and embark to achieve similar success against other ills in the society". According to Rotary National PolioPluus Committee member Mr. Raman Bhatia "It is a significant day for our countrymen and we are happy we reached this milestone today in ensuring a Polio-free life for country's children". Rotary club members worldwide have contributed more than US$1.2 billion and countless volunteer hours to the polio eradication effort. Rotary is a global humanitarian organization with more than 1.2 million members in 34,000 Rotary clubs in over 200 countries and geographical areas. Rotary members are men and women who are business, professional and community leaders with a shared commitment to make the world a better place through humanitarian service. Rotary's top priority is the global eradication of polio and is the leading partner of GPEI. The other spearheading partners in the Global Polio Eradication Initiative are the World Health Organization, UNICEF, and the U.S. Centers for Disease Control and Prevention. ]]> <![CDATA[Doctor-developed Iridotomy lens for Glaucoma ]]> https://biospectrumindia.com/news/95/4860/doctor-developed-iridotomy-lens-for-glaucoma-.html https://biospectrumindia.com/news/95/4860/doctor-developed-iridotomy-lens-for-glaucoma-.html Thu, 16 Jan 2014 14:26:11 +0530 Volk Optical has launched a new specialty lens for iridotomy procedures. Developed in conjunction with Eytan Blumenthal MD, the Blumenthal Iridotomy lens design increases access to the periphery for more efficient glaucoma treatment with less potential for damage to surrounding tissues. The design of the contact lens indents the cornea to open the angle and flatten the peripheral iris, delivering better patient outcomes with less post-laser inflammation. The Blumenthal Iridotomy's precise positioning and sharply focused laser spot minimizes iris tissue collateral damage and distances the cornea from the iris to reduce the risk of endothelial cell damage. The Blumenthal Iridotomy lens improves over classic lenses, as it is the only lens with corneal indentation capability for enhanced viewing of the far periphery. Constructed using Volk's patented aspheric optics, the lens delivers better image quality and improved laser burn. Lower energy is required, reducing thermal collateral damage. The large lens housing improves lens grip and alignment for oblique viewing of the entire chamber. Eytan Blumenthal, MD is Chairman of the Department of Ophthalmology at Rambam Health Care Campus (Hafia, Isreal). This is his second lens collaboration with Volk. ]]> <![CDATA[SunTech Medical and PRA sign agreement]]> https://biospectrumindia.com/news/95/7444/suntech-medical-and-pra-sign-agreement.html https://biospectrumindia.com/news/95/7444/suntech-medical-and-pra-sign-agreement.html Thu, 16 Jan 2014 14:19:21 +0530 The SunTech Medical Oscar 2 Ambulatory Blood Pressure Monitoring (ABPM) system has been selected by PRA for use in a Phase I clinical study. The study will investigate the inhibition of degenerative mechanisms to provide improved neuro protection for those with Alzheimer's disease. SunTech Medical and PRA have signed a seven-month lease agreement for 23 Oscar 2 ABPM systems to be used in the study, taking place at the PRA research facility in Lenexa, KS. One of the many applications for ABPM is 24-hour monitoring and management of cardiac activity during drug therapy in pharmaceutical research trials. ABPM allows researchers to obtain a comprehensive picture of the effects of the medication on a patient's daily blood pressure levels. The Oscar 2 ABPM system provides reliable measurement and recording of 24-hour blood pressure data. It was the first ambulatory blood pressure monitor to achieve independent validation by both the BHS and ESH protocols for testing the accuracy of ambulatory blood pressure monitors. The patented Orbit blood pressure cuff uses a form-fitting sleeve to prevent slippage while patients carry out daily tasks, leading to more reliable data. AccuWin Pro v3 software provides practical, automated and flexible analysis, interpretation and reporting of 24-hour blood pressure data. ]]> <![CDATA[Dr Reddy's launches Hypertension drug Optidoz ]]> https://biospectrumindia.com/news/95/6989/dr-reddys-launches-hypertension-drug-optidoz-.html https://biospectrumindia.com/news/95/6989/dr-reddys-launches-hypertension-drug-optidoz-.html Tue, 14 Jan 2014 12:53:19 +0530 Dr Reddy's Laboratories hasannounced that Optidoz - a drug for the treatment of Essential Hypertension has been approved and will be made available in the Indian Pharmaceutical market. Optidoz is a single pill combination of three anti-hypertensive drugs (Amlodipine 2.5 mg, Telmisartan 20 mg and Hydrochlorothiazide 6.25 mg) with optimal dose of individual drugs. The drug is priced at Rs 8 per tablet and Rs 80 for a strip of 10. Efficacy and safety of Optidoz has been established through the CONTROL-Hypertension clinical study, approved by Drug Controller General of India (DCGI). The study was conducted between November 2010 and June 2011 as per the Good Clinical Practices (GCP) in accordance with the Helsinki Declaration. The study demonstrated that Optidoz controls hypertension faster and more effectively with much lesser incidence of adverse events as compared to standard dose double drug combination. Optidoz will also simplify the traditional, complicated step-care treatment approach for hypertension management. The prolonged blood pressure control with minimal adverse effects is expected to improve efficacy response in normalizing the blood pressure due to good tolerability with Optidoz and enhanced compliance in patients. Hypertension is the most prevalent chronic disease in India. Approximately 32 percent of the adult Indian population suffers from high blood pressure. Over the last six decades, the prevalence has increased twelve-fold in urban areas and seven-fold in rural areas. Optidoz is an attempt from Dr Reddy's to alleviate hypertension related disease burden in India. ]]> <![CDATA[Biocon Academy program kicks-off in the city]]> https://biospectrumindia.com/news/95/3567/biocon-academy-program-kicks-off-in-the-city.html https://biospectrumindia.com/news/95/3567/biocon-academy-program-kicks-off-in-the-city.html Tue, 14 Jan 2014 12:50:00 +0530 On January 10, 2014, Biocon Academy, a centre of excellence for advanced learning in applied bio-sciences, announced the commencement of its first flagship program, 'Biocon KGI Certificate Program in Biosciences', in collaboration with California-based Keck Graduate Institute (KGI). Ms Kiran Mazumdar-Shaw, CMD, Biocon, said, "I would like to extend a warm welcome to our first batch of students for the Biocon KGI Certificate Program. This program will provide a unique opportunity for life sciences students to take advantage of the world-class advanced learning and training program that straddles both theory and project-based learning. I am very pleased to see the quality of the students who have enrolled for this program. Biocon Academy aims to address the skill deficit and develop high-end talent and catapulting the Indian biopharma sector to the next level of growth." This 16-week, intensive full-time program will be delivered by renowned faculty from KGI and Biocon Academy. The program's international curriculum encompasses R&D, production as per GMP, quality assurance, regulatory, product development and professional skills, which will enhance the career prospects for fresh biotech graduates as well experienced biotechnologists. Dr Sheldon M Schuster, president, Keck Graduate Institute (KGI), said, "KGI is known for developing innovative and highly focused educational programs for those interested in pursuing a career in life sciences. Built on the KGI graduate-level curriculum, this program will offer students who want to develop the skills they need to work in a complex, global and highly regulated industry. For potential employers, such as Biocon, the creation of this program means having a wider pool of life science professionals who are ready to contribute to their goals from day one." The academy received over 150 applications from all across India for the first batch after admissions opened in November 2013. About 30 students have been selected through a rigorous process to be a part of the inaugural batch. The first batch includes a good mix of both bioscientists with experience as well as fresh engineering and science graduates quoted the company's press release. The first batch of students is expected to undergo real time classes with KGI faculty and will be mentored by subject matter experts at Biocon. Biocon Academy is an initiative to develop high-end talent for the biotech sector by Biocon. ]]> <![CDATA[Wockhardt's regulatory unit gets new head ]]> https://biospectrumindia.com/news/95/3568/wockhardts-regulatory-unit-gets-new-head-.html https://biospectrumindia.com/news/95/3568/wockhardts-regulatory-unit-gets-new-head-.html Tue, 14 Jan 2014 12:49:18 +0530 After facing a wave of troubles from the US drug regulatory body through the last 12 months, leading Indian drug maker Wockhardt introduced a whole host of changes in its systems. The latest one is the appointment of Mr Zoher Sihorwala, to head the company's regulatory and compliance units. Mr Zoher Sihorwala will be joining the Mumbai based pharma giant after completing his stint as vice president of global regulatory affairs at Dr Reddy's. As per reports, Mr Sihorwala has spent 20 years in the pharma business, primarily handling regulatory affairs. A master of pharmacy in medicinal and pharmaceutical chemistry from Jamia Hamdard University, Sihorwala started his career as a junior assistant with Nicholas Piramal (now Piramal healthcare) in 1993. He later worked with Glenmark, Cadila Healthcare and Ranbaxy. At Dr Reddy's, Mr Sihorwala was part of the team that resolved the regulatory and compliance issues related to the company's Mexico facility. Wockhardt is said to be counting on this experience to effectively resolve the compliance issues it is facing from US and UK. Wockhardt had locked horns with the US Food and Drug Administration last year when two of its manufacturing facilities at Aurangabad in Maharashtra were banned after good manufacturing practices violations were found. This ban led to the halt in exports to the US that cost the company $500 million in sales. Late last year, the Medicines and Healthcare Products Regulatory Agency (MHRA) from UK also raised data integrity issues against the Indian drug maker. ]]> <![CDATA[Cadila, Swedish firm develop arthritis drug]]> https://biospectrumindia.com/reports-white-papers/95/4831/cadila-swedish-firm-develop-arthritis-drug.html https://biospectrumindia.com/reports-white-papers/95/4831/cadila-swedish-firm-develop-arthritis-drug.html Tue, 14 Jan 2014 12:21:43 +0530 NovaSAID, part of Sweden-based Karolinska Development, and India- based Cadila Pharmaceuticals have entered into a strategic partnership to develop new treatments for inflammation and pain in conditions such as rheumatoid arthritis. The companies will collaborate around preclinical and clinical development of drug candidates that have been developed by NovaSAID and the development will be conducted at Cadila Pharmaceuticals' facility in Ahmedabad, India. According to the agreement, all revenue generated from the sale and marketing in India, Middle East and Africa of products covered by the agreement will be retained by Cadila and net sales in all other countries will be shared by the two companies. Cadila will bear all costs associated with the program through to phase II. "This partnership gives the shareholders of NovaSAID the opportunity to take the company forward with great resources and no further costs. Cadila's drug development expertise matched with NovaSAID's scientific excellence provides a solid platform for the further development of these novel drug candidates. If successfully developed, valuable deals could be signed in major territories such as the US and Europe to the benefit for Karolinska Development's shareholders," said Dr TorbjÃ¶rn Bjerke, CEO, Karolinska Development. Speaking on the occasion, Dr Rajiv I Modi, chairman and MD, Cadila Pharmaceuticals, said, "We have entered this partnership combining scientific expertise of NovaSAID and our drug development capabilities to work towards novel solutions in treatment of pain and inflammation, which is one of the largest therapy areas. This is in line with the vision of our founder chairman, Mr I A Modi, who believed in nurturing innovations and bringing them to Indian patients at an affordable cost. Cadila Pharmaceuticals has a track record of making available, many first-in-the-world innovative products like Polycap (five-in-one pill for prevention and treatment of cardiovascular diseases), Risorine (Innovative solution for treatment of Tuberculosis) and most recently introduced Mycidac-C, which is the world's first active immunotherapy in lung cancer." Most of medical treatments for inflammation and pain are associated with unwanted side effects such as an increased risk for myocardial infarction and gastric ulcers. NovaSAID's drug candidates targets an enzyme called microsomal prostaglandin E synthase -1 (mPGES-1), a critically important mediator of inflammation and pain, which theoretically should reduce the risk for side effects. The collaboration with Cadila will provide the resources to take this program into clinical development and further towards the market. "mPGES-1 constitutes an important target for drug discovery and development of analgetic and anti-inflammatory drugs. In addition for use in chronic inflammatory diseases, effective enzyme inhibitors may also address a broad range of other diseases with concomitant inflammation such as atherosclerosis, stroke and cancer", said Mr Per-Johan Jakobsson, co-founder and director, NovaSAID, and associate professor, Karolinska Institutet. ]]> <![CDATA[German firm buys $200 million stake in Indian generic company]]> https://biospectrumindia.com/news/95/3362/german-firm-buys-200-million-stake-in-indian-generic-company.html https://biospectrumindia.com/news/95/3362/german-firm-buys-200-million-stake-in-indian-generic-company.html Mon, 13 Jan 2014 18:39:15 +0530 Gland Pharma, a leading Indian pure-play generic injectable pharmaceutical products company, has signed an agreement under which KKR, a global investment firm, will acquire a minority stake in the company for approximately $200 million, including KKR's acquisition of the entire stake held by Evolvence India Life Sciences Fund (EILSF), an existing private equity investor in Gland Pharma. Through the partnership, Gland Pharma expects to expand its next phase of growth materially by expandING manufacturing capacities and investing more in development work with the goal of expanding product registrations. KKR's investment in Gland Pharma represents its fourth announced investment from the KKR Asian II Fund and its second overall private equity investment in 2013. ]]> <![CDATA[Novartis pledges to eliminate leprosy]]> https://biospectrumindia.com/news/95/3358/novartis-pledges-to-eliminate-leprosy.html https://biospectrumindia.com/news/95/3358/novartis-pledges-to-eliminate-leprosy.html Mon, 13 Jan 2014 18:26:39 +0530 As part of its pledge to fight neglected diseases in the developing world, Novartis and the Novartis Foundation for Sustainable Development has launched a new leprosy strategy focused on interrupting leprosy transmission through early diagnosis and treatment, contact tracing of former patients, diagnostic tools and strict surveillance and response. Over the past eight years, however, the number of newly diagnosed leprosy patients has plateaued at around 230,000 cases per year. "As part of our pledge to fight neglected diseases in the developing world, Novartis and the Novartis Foundation for Sustainable Development are committed to going the last mile to help make leprosy history," said Mr Joseph Jimenez, CEO, Novartis. ]]> <![CDATA[ Insulin injection day announced]]> https://biospectrumindia.com/news/95/5327/-insulin-injection-day-announced.html https://biospectrumindia.com/news/95/5327/-insulin-injection-day-announced.html Mon, 13 Jan 2014 16:59:06 +0530 In Toronto General Hospital on January 11, 1922, a novel invention changed the lives of millions living with Diabetes and revolutionized its management, particularly Type I diabetes. 92 years from then, we can see the observation of insulin injection day for first time in India. "Insulin remains a critical component of treatment of Diabetes, not only type I but also in many cases of Type II. At present injection remains the only practical means to deliver insulin. It is a welcome move that a day has been dedicated to deliberate on Insulin Injection by FIT. This should have a favorable impact on the acceptance of insulin injection among both physicians and patients," said Prof. S.V.Madhu, Professor & Head, Dept. of Medicine & Endocrinology, UCMS-GTB Hospital & Secretary, Research Society for Study of Diabetes in India(RSSDI)said, Dr. Madhu added, "More than 80 % of people have psychological resistance to even initiate an insulin therapy, despite it being indispensable for glycemic control to manage the disease. The recommendations by FIT India have been immensely helpful in optimizing insulin injection technique for both healthcare workers and patients and have improved the overall acceptance of insulin delivery and injections." Counseling elderly or geriatric patients for self-injection can be a challenging task. Unlike their younger peers, they may have certain age related potential difficulty in executing the instructions for injections properly. The FIT recommendations suggest that physicians should not use age as an excuse to avoid usage of insulin which can delay the treatment and result in further complications. Along with insulin initiation for elderly patients, health-care providers must ensure the involvement of responsible family members/attendants during the selection of insulin and explanation of injection technique. According to Dr. Rajeev Chawla, Joint Secretary, RSSDI and Sr. Consultant Diabetologist & Director, North Delhi Diabetes Centre, ""As per latest survey, more than 50% of diabetic patients in the city do not adhere to appropriate insulin treatment practices, and 48% do not know about right injection techniques. As insulin treatment is vital for blood glucose control, inappropriate injection skills compromise the dosage accuracy and its effectiveness. Moreover, it may also lead to pain with bleeding and a risk of contamination." A scientific advisory board of well-known endocrinologists and diabetes experts compiled the FIT India recommendations based on clinical evidence, implications for patient therapy and the judgment of a group of experts in order to promote best practices in injection technique and bring uniformity in insulin injection technique diabetes patients and healthcare professionals. Dr. B M Makkar, Dr B.M. Makkar, Senior Diabetologist and Obesity Specialist, Sri Balaji Action Medical Institute, ""FIT India is dedicated to raise awareness on correct injection practices for an effective and safe diabetes therapy management and compliance. In the past one year FIT has launched the first ever India-specific clinical recommendations for appropriate insulin injection techniques and reached out to more than 180+ hospitals and 15000+ HCPs and patients. With these recommendations we aim to bring uniformity in insulin injection technique throughout the country and help impart the right education to both healthcare providers and diabetes patients." Several factors, including method of administration, dosing, compliance, selection of injection site, depth of the injection, time lapse before withdrawing the needle and misconceptions about insulin therapy, influence the success of insulin injection therapy. In November 2012 Forum for Injection Techniques (FIT India) and BD India had come together to launch the first Indian clinical recommendations for best practices in insulin injection techniques in India. Insulin injection recommendations Needle length * For children and adolescents, a 4, 5, or 6 mm needle should be used. A1 * Adults, including obese patients, can use 4, 5, and 6 mm needle length. A1 Site rotation * An easy-to-follow rotation scheme should be taught to the patients from the onset of injection therapy. A2 Needle/syringehygiene * Do not reuse needles. A2 * Use a new needle for each injection. A2 Lipohypertrophy * Injection sites should be inspected at every visit. Patients should be taught to inspect their own sites and should also be given training on how to detect lipohypertrophy. A2 * The best current strategies to prevent and treat lipohypertrophy are to rotate the injection sites with each injection, using larger injecting zones and non-reuse of needles. A2 Injection sites * Injection should be given at a clean site with clean hands. A2 * Prior to the injection, the site has to be palpated for lipohypertrophy and inspected for wounds, bruises, or blisters. If the injection site shows any signs of these, then a different site should be selected until the problem has been resolved. A3 Safety issues * Safety needles should be recommended whenever there is a risk for a contaminated needle-stick injury. B1 ]]> <![CDATA[Cadila collaborates with NovaSAID to develop compounds for inflammatory pain]]> https://biospectrumindia.com/news/95/1443/cadila-collaborates-with-novasaid-to-develop-compounds-for-inflammatory-pain.html https://biospectrumindia.com/news/95/1443/cadila-collaborates-with-novasaid-to-develop-compounds-for-inflammatory-pain.html Mon, 13 Jan 2014 16:11:16 +0530 The companies will collaborate around preclinical and clinical development of drug candidates that have been developed by NovaSAID and the development will be conducted at Cadila Pharmaceuticals' facility in Ahmedabad, India. Speaking on this strategic partnership, Dr Rajiv Modi, CMD, Cadila Pharmaceuticals said, "We have entered this partnership combining scientific expertise of NovaSAID and our drug development capabilities to work towards novel solutions in treatment of pain and inflammation, which is one of the largest therapy areas." According to the agreement, all revenues generated from the sale and marketing of products, covered in the agreement, in India, Middle East and Africa will be retained by Cadila. However, the net sales in all other countries will be shared by the two companies said the press release on Monday. Cadila claimed that it will bear all costs associated with the program through to Phase-II. "This partnership gives the shareholders of NovaSAID the opportunity to take the company forward with great resources and no further costs. Cadila's drug development expertise matched with NovaSAID's scientific excellence provides a solid platform for the further development of these novel drug candidates. If successfully developed, valuable deals could be signed in major territories such as the US and Europe to the benefit for Karolinska Development's shareholders", said Dr TorbjÃ¶rn Bjerke, CEO, Karolinska Development. Cadila Pharmaceuticals has launched many first-in-the-world innovative products like Polycap (5-in-1 pill for prevention and treatment of CVDs), Risorine (treatment of TB) and recently, the introduction of Mycidac-C, which is the world's first active immunotherapy for lung cancer. NovaSAID is a Swedish-based research company developing compounds for treating inflammatory pain. ]]> <![CDATA[Hope floats for HIV patients!]]> https://biospectrumindia.com/features/95/5076/hope-floats-for-hiv-patients.html https://biospectrumindia.com/features/95/5076/hope-floats-for-hiv-patients.html Fri, 10 Jan 2014 11:35:37 +0530 Compared to the times of complete despair and loss of hope, there has been a remarkable scale up of treatment over the period of time, for HIV that causes Acquired Immunodeficiency Syndrome (AIDS) in the human body and its subsequent break down. However, the improvements have hardly helped to solve the deeper problem as it continues to require lifetime treatment, besides every one person put on treatment, two newly infected getting added to the list. The disease has been an area of major concern for the various global health agencies across the world, since its identification in 1983. The virus has already killed 35 million people globally. In India alone, there are around 2.7 million people who have been affected by the AIDS. Therefore, a broadly effective AIDS vaccine would be a powerful asset to the efforts to stop the spread of HIV. However, given the complexities in the nature of the virus, the forging of partnerships involving international collaborations and the open sharing of scientific knowledge, is expected to provide direction and boost to translational research. Globally efforts continue As per Dr Wayne C Koff, chief scientific officer & senior vice president - R&D, International AIDS Vaccine Initiative (IAVI), "Earlier we were not able to identify the proteins clearly. In last few years, we have been able to make the crystal structure. This has been made possible only because of advances in basic sciences. Evolution of the bNAb's in our times has led to understanding and raised new hopes. Combination of antibodies is important for tackling virus. Year after year, we have much more to talk about hopefully!"Despite some failed attempts in past, the outcomes have been unable to deter the researcher's pursuit. "Though the science is the game of hits and misses, it is also a great learning experience where we learn from each failed effort to launch renewed efforts to tackle the situation. At the moment, we have identified four vulnerable sites on the virus and are now looking for more sites on the one found in India," said Dr Koff while responding to query on failure of few vaccine candidates in the past. Founded in 1996, the IAVI is a global not-for-profit organization, whose mission is to ensure the development of safe, effective, accessible, preventive HIV vaccines to use throughout the world. It is associated with 25 countries to research, design and develop AIDS vaccine candidates. The HIV Vaccine Design Program will capitalize on recent research advances that have sparked a renaissance in AIDS vaccine research and development (R&D). In September 2009, scientists at IAVI and their colleagues in the Neutralizing Antibody Consortium (NAC), which is run by IAVI, reported the isolation of a pair of potent. And very broadly neutralizing antibodies against HIV, that discovery, the first of its kind in a decade, was followed by the isolation of other broadly neutralizing antibodies (bNAbs) by researchers at the Vaccine Research Center of the US National Institutes of Health and of still more by the IAVI-affiliated team. The most promising of these antibodies are now being scrutinized by researchers to elucidate the specific mechanisms by which they bind to and neutralize HIV. The idea is to create artificially synthesized mimics of their targets on HIV, to be used in vaccines to elicit similarly potent bNAbs and teach the immune system how to repel HIV infection. Dr Robin A Weiss, emeritus professor, University College London, chair - IAVI Scientific Advisory Committee and HVTR Laboratory Scientific Advisory Group, said, "From being a death sentence, the HIV-AIDS has now been called a treatable disease from the year 1996 onwards. People with HIV have worst cases of tuberculosis (TB). With 60 percent of them being affected, the women are the worst sufferers in the most affected nations such as Africa." Playing a responsible role The Indian government on its part has been playing a very active role. Apart from health ministries, National AIDS Control Organization (NACO) that has been advocating on preventive measures and social awareness, the various other agencies from science and technology ministry have encouraged research in the area. The Pune based National AIDS Research Institute (NARI) funded by Indian Council for Medical Research (ICMR) has progressively expanded its activities in various aspects of research on HIV and AIDS through infrastructural development, capacity building and research programs. Another big initiative is Gurgaon based, The Translational Health Sciences and Technology Institute (THSTI), an autonomous institute of the Indian government's Department of Biotechnology (DBT) which will primarily focus on one of the greatest scientific challenges of AIDS vaccine design and development. In collaboration with the IAVI, the program is focused on the elicitation of antibodies capable of neutralizing a broad spectrum of circulating HIV variants, a problem that stems in large part from the almost unparalleled mutability of HIV. The IAVI-THSTI collaborative program is participating in a much coordinated, global effort to create replicas of bNAb targets in the laboratory for use as immunogens, which are the active ingredients of vaccines. This program has been charged with the complex task of developing, testing and then implementing strategies to rapidly screen large numbers of bNAb-based immunogens against HIV-1 and to prioritize them for further evaluation in preclinical studies. It is expected that the program using high throughput (HT) screening will ultimately lead to strategies for next generation immunogen design and expand the number of AIDS vaccine candidates available for assessment in human trial. Dr Rajat Goyal, country director - India, International AIDS Vaccine Initiative (IAVI), mentions that its aim was never the ownership. "We were happy when the government of India chipped in with the funding. Pushing the clinical research towards the drug development was our focus and the DBT with its work on research projects, Indian Council for Medical Research (ICMR) on clinical aspect and NACO on the epidemiological part have been key partners." He also feels great about the amount of funding from DBT and ICMR, having been scaled up in the recent years. The THSTI-IAVI program is an integral part of the THSTI cluster of research centers. It will be linked closely to both the hub of the NAC, the IAVI Neutralizing Antibody Center at The Scripps Research Institute in La Jolla, California, and to IAVI's AIDS Vaccine Design and Development Laboratory in New York. The work conducted also complements a current partnership IAVI has with the Indian Medicinal Chemistry Program (IMCP), under the auspices of the DBT, to design and generate conceptually novel HIV immunogens. Other institutions participating in this partnership include the International Centre for Genetic Engineering and Biotechnology in New Delhi, and the Indian Institute of Science, Bangalore. According to Dr Sudhanshu Vrati, head, Vaccine & Infectious Disease Research Centre, and dean, Translational Health Science and Technology Institute (THSTI), other than funding that has come from IAVI, they have looked at the technical expertise. "We just completed phase III of rotavirus vaccine. The new opportunities in vaccines have arrived and increase in knowledge base. We look forward to applying the same in this case as well." The partnership has collateral benefits for the nation that goes beyond the advancing of development of broadly effective AIDS vaccines. Most significantly, the DBT expects that it will contribute to India's efforts to become a world leader in translational research-the science of converting promising laboratory concepts into biomedical products that can be tested in people and, ultimately, manufactured by industry. The annual operational funding for the program as per Dr Sukhdev Sinha, advisor, DBT, is close to Rs 40 crore. The DBT has put another Rs 6 crore into various 25 projects that are into R&D of these diseases. He adds, "India holds a very unique place in the vaccine development. We know that the vaccine development success stories in India have made us to believe in wonders. Now the focus is more on few major disease areas such as HCV, HIV and TB. At the moment, along with the DBT, the DST, CSIR and other too are putting money in HIV infection research in one or the other way." ]]> <![CDATA[No clinical trials, no new drugs: Where is this going to lead India?]]> https://biospectrumindia.com/news/95/3244/no-clinical-trials-no-new-drugs-where-is-this-going-to-lead-india.html https://biospectrumindia.com/news/95/3244/no-clinical-trials-no-new-drugs-where-is-this-going-to-lead-india.html Thu, 09 Jan 2014 23:46:00 +0530 In the midst of draconian regulations and uncertainties encircling the Indian clinical trial scene, the Indian Society for Clinical Research (ISCR), a body which primarily represents the interest of all stakeholders in the clinical research, organized a press meet on January 9, 2014, as a kick-starter for its two-day 7th annual conference themed, 'Clinical Research at Crossroads', happening from January 10-11, 2014, at The Lalit Ashok, in Bangalore. Eminent academician and clinical pharmacologist Padmashree Prof Ranjit Roy Chaudhury will be the guest of honor at the two-day conference along with distinguished clinical research professionals who will discuss the recent developments in clinical research across the globe, and create a forum to help clinical research professionals to appreciate what is happening in India and take some of the best practices and implement them in the country. India has about 16% of the world's population and 20% of the global disease burden. However, only less than 1.5% of global trials take place in the country. Ms Suneela Thatte, president, ISCR, who was at the press meet said that the media is an important stakeholder in this regard, and that it should send across the right message about clinical trials, which has the ability to bring new medicines to meet unmet medical needs. She said, "Media brings an important role in bringing about awareness about clinical trials and patient rights, ensuring the voice of clinical researchers and stakeholders are heard by policy makers." "In our country, we deal with traditional diseases like malaria and TB, nutritional diseases and the diseases of developed nations like hypertension, cancer and diabetes. We don't have enough vaccines to take care of the population to fight new and emerging diseases," Ms Thatte further added. Dr Arun Bhatt, president, Clininvent, added, "To develop drugs and medicines, one has to do research and conduct clinical research. It takes more than 10 years to develop new drugs and about 5 years for clinical trials. It doesn't happen over a short period of time. Trials have significantly dropped by 50% compared to what it was." Dr Suresh Menon, chief scientific officer, Novartis, who was also present at the event opined, "People need to understand why clinical research is being done. The medicines have to be tried out in different phases or steps. Without clinical trials, we will not be able to introduce and make available new medicines for life threatening diseases for patients." Talking about the significance of clinical trials, "A lot of drugs have been discovered in the last three or four decades to manage diseases effectively. Without clinical trials science cannot really progress. The crux of the real challenge in 2013 was the delay in the approval of research proposals at government level," added Dr Menon. He believes that 2014 will bring exclusive clarity in norms and the government's support will make it possible for new medicines being made available to patients in India much earlier than how it is today. Dr Prem Pais, professor of medicine and head division of clinical research and training, St John's Research Institute, touched about the value and role of clinical research in India. "Clinical research means doing research in which a human being is involved. It is not just about the medicines. Clinical research done on animals in laboratory is not clinical research. All of us want to protect the rights and safety of patients all over the world. India has been doing clinical research in a big way in the last 10 to 12 years. However, countries like US have been doing it since 1950s. The new regulations that have come in is making it difficult for many clinical researchers causing uncertainties," said Dr Pais. The current clinical trials regulations in India has made many international organizations like National Institute of Health (NIH, USA), Canadian Institute of Health Research (CIHR, Canada), Medical Research Council (MRC, UK) and The Wellcome Trust (UK), withdraw their clinical trials in India and have pulled out of the country owing to the uncertain regulations. "In the long run, through clinical trials we'll be able to discover what causes diseases and see which treatment works and which doesn't," added Dr Pais. In conclusion, Dr Suneela added, "Unless trials happen, drugs cannot be marketed in India. Drugs have to be studied in different genetic population. We'll have discoveries going on in the rest of the world, but Indian patients will continue to remain deprived." ]]> <![CDATA[BioSpectrum announces News Makers of the Year]]> https://biospectrumindia.com/features/95/1128/biospectrum-announces-news-makers-of-the-year.html https://biospectrumindia.com/features/95/1128/biospectrum-announces-news-makers-of-the-year.html Thu, 09 Jan 2014 16:16:00 +0530 As the Asia Pacific region caught the fancy of foreign multinational giants, the number of acquisitions and mergers rose, investments increased, joint ventures mushroomed, innovative devices were created and marketed, evidently the overall promise that Asia showed in the life sciences sector grew to a whopping 96 percent in our yearly poll. BioSpectrum has launched its special feature with a roundup of all that happened in the last 12 months and presents Flashback 2013. The elaborate feature will have all the hits and misses of the year from the Asian life sciences industry, the path breaking products and ground breaking medical devices that made it to the top five in Asia through the year. Further, the special report will have a roundup of 2013's highlights from India, Malaysia, Taiwan, Thailand, Australia, Korea, Singapore, Malaysia and other prominent countries from the APAC region. All the burning issues, starting from the biggest settlement ever made to the US drug regulator, the Food and Drug Administration over quality issues of drugs, the darkest revelation of the year in the drug business - GlaxoSmithKline's corrupt actions in China and the landmark verdict of the year that had the US Supreme Court declare that 'Human Genes cannot be Patented' will be covered in the feature. BioSpectrum brings to its readers, 2013's bests and hall of shame in its special issue on January 9, 2014. Watch this space for more. ]]> <![CDATA[May bioscience be part of election manifestos!]]> https://biospectrumindia.com/features/95/2983/may-bioscience-be-part-of-election-manifestos.html https://biospectrumindia.com/features/95/2983/may-bioscience-be-part-of-election-manifestos.html Thu, 09 Jan 2014 15:55:39 +0530 The past few years have not seen much importance given to biotech by the main political parties in the country. In fact, the impetus that biotech got during the national elections in 2004 is missing now. India approved Bt cotton in 2002 and the cotton yield started to soar soon thereafter. The farmers were not bothered by the controversies surrounding the introduction of the product in India then and read- ily adopted Genetically Modified (GM) cotton. This forced most of the political parties to openly canvas for GM technology. The 2003 elections saw nearly all the leading and regional parties in the country laying claim to the contribution of Bt cotton growth in their respective regions. They splurged on advertisements brandishing the success of the state in the agriculture: courtesy-Bt cotton. From a fervor when Bt cotton was considered as a factor that could win votes, today the in- dustry is in a mess. The constant complaint during pre-reforms or the liberalization era that kick started in the early 1990s was that the decisions were mired in bureaucratic processes. However, things have changed during the past decade. While the industry, the biotech sec- tor in particular, received favorable response from the bureaucratic fraternity and admin- istrators, the political will to address the nation's problems in the areas of national health, agriculture and fuel through introduction of new technology is lagging behind severely. The administrators have worked favorably to aid the industry. It is now the turn of the political community to move forward and commit to better healthcare, nutrition, food and energy security. There has been near paralysis of the entire bioscience industry-be it in the BioPharma, BioAgri, or the CRO sectors. The Biotechnology Regulatory Authority of India (BRAI) Bill has not yet been passed, though it has been introduced in the budget session of the Parliament in 2013. Furthermore, there's complete stalemate on the intro- duction of GM foods. Similarly, there are concerns over clinical trials in the country. With 2014 elections on the horizon, it is time that the national parties talk about the bio- tech agenda in their manifestos. Political parties should take a clear stand on some of the key challenges effecting the country like introduction of GM food crops in the country. Or promoting clinical trials in a transparent and scientific way. Or promoting use and devel- opment of better biofuels and renewable energy. This is an opportunity for the political parties to go to the public to not only seek feedback on key issues related to health, energy, and food security from both the consumers and producers but also assuage the miscon- ceptions if any and direct the course of action. Political parties should not shy away from expressing their commitment to science and technology for the overall growth of the economy and country. And industry should help the political parties and their leaders to assume a visionary role to help India to leapfrog with new-age responsible science and technology development and affordable and acces- sible service delivery. It is time for us to usher a new India and not put biotech in the back burner. Only then can India become a global power. I strike a chord with Dr Krishna Ella, the 2013 BioSpectrum Person of the Year and MD, Bharat Biotech, when he says, "today's neglected diseases are tomorrow's global problems" and India can play a significant role in solving the global problems. This year presents a good opportunity for all of us to push for a new and memorable chapter in the history of biotech. Wish you all the best and happy and prosperous New Year. ]]> <![CDATA[ICMR disease focused technologies ready for commercialization]]> https://biospectrumindia.com/news/95/5082/icmr-disease-focused-technologies-ready-for-commercialization.html https://biospectrumindia.com/news/95/5082/icmr-disease-focused-technologies-ready-for-commercialization.html Thu, 09 Jan 2014 11:53:00 +0530 The Department of Health Research (DHR), Government of India has a special programme aimed at development of indigenous affordable technologies for health care. Under the same, the technologies developed by Pune based ICMR's National Institute of Virology (NIV) include recombinant vaccine for Hepatitis E vaccine and combination of Hepatitis E & Hepatitis B vaccines using a novel approach, ELISA Test for Rotavirus and Recombinant protein- based assay for diagnosis of hepatitis E. The salient features of the recombinant vaccine is that its liposome formulation of T1NE protein of an Indian strain of genotype 1 HEV serves as an effective candidate vaccine for hepatitis E. The liposome formulation of T1NE protein of an Indian strain of genotype 1 HEV along with the S protein of HBV serves as an effective combined candidate vaccine for hepatitis E and hepatitis B. The T1NE protein / corresponding DNA of an Indian strain of genotype 1 HEV has features such as ease of production in bacterial system, Easy purification, Stability, Easy liposome encapsulation formulation, Easy scalability. Research is upto laboratory scale; successful clinical trial in rhesus monkeys has been completed. ELISA Test for Rotavirus can be used for detection of rotavirus from the fecal samples of diarrhoea patients. The rapid ELISA test was developed at NIV, Pune. It is easy to perform, has high sensitivity and specificity and is cost effective as large number of fecal samples could be tested using indigenously developed reagents. This can essentially avoid unnecessary use of antibiotics in diarrhoea patients. This kit is also useful during surveillance studies to obtain data on disease burden. This technology has been validated. An Indian Patent application no. 581/BOM/1999 has been filed. Recombinant protein- based assay for diagnosis of hepatitis E has the complete T1ORF2/ T4ORF2 proteins expressed in baculovirus system and the truncated T1ORF2 protein (T1NE, 150 aa) serve as the detecting antigens in ELISA for diagnosis of Hepatitis E. These 3 recombinant proteins can be used for the development of diagnostic assays for hepatitis E. The T1NE protein of an Indian strain of genotype 1 HEV can be easily produced in bacterial system. This protein has high yield, can be easily purified, stable and has easy scalability. ]]> <![CDATA[Advinus Therapeutics meets 1 year milestone in drug discovery alliance ]]> https://biospectrumindia.com/news/95/3559/advinus-therapeutics-meets-1-year-milestone-in-drug-discovery-alliance-.html https://biospectrumindia.com/news/95/3559/advinus-therapeutics-meets-1-year-milestone-in-drug-discovery-alliance-.html Wed, 08 Jan 2014 17:43:00 +0530 Advinus Therapeutics, the TATA promoted pharmaceutical R&D company, announced that it has received the first year milestone in its R&D collaboration with Takeda Pharmaceutical. The achievement of this milestone underscores the success of the collaboration and also provides validation of Advinus' capabilities in innovative drug discovery and Takeda's confidence in these capabilities. As a consequence, a payment of $3 million will be made by Takeda to Advinus to mark the achievement. "Achievement of the rather challenging first year milestone can be attributed to the truly collaborative nature of our relationship with Takeda as well as Advinus' young talent's ability to solve complex problems with efficiency and speed," said Kasim Mookhtiar, CSO of Advinus. In October 2012, Advinus and Takeda announced a multi-year multi-project collaboration in the area of drug discovery. In this venture, Advinus is responsible for carrying out all the research required to identify candidate molecules for clinical development in several therapeutic areas while Takeda is responsible for the development and commercialization of these candidates. ]]> <![CDATA[MORATORIUM OR NO MORATORIUM]]> https://biospectrumindia.com/features/95/3076/moratorium-or-no-moratorium.html https://biospectrumindia.com/features/95/3076/moratorium-or-no-moratorium.html Wed, 08 Jan 2014 15:12:00 +0530 The use of r DNA technology in Agriculture has revolutionized food production of the world. The scientists using this technology has been able to produce herbicide resistant, insect resistant and disease resistant plants. In addition to this use of biotechnology tools have given us more nutritious and flavorful foods like golden rice and flavor-saver tomatoes. Thus biotechnology has given us more abundant, flavorful and nutritious foods produced with less dependence on pesticides and herbicides. Indiscriminate use of pesticides in food and non-food crops is creating health problems and may become the major cause of dreaded disease like cancer. Minimum use of pesticides on crops can save us from this dreadful disease. This has been further strengthened by the commitment of Agriculture and Processed Food Products Export Development Authority of India that our several food products have been rejected by several countries based on amount of pesticide residues. To cite example, America does not like our chili powder, Russia and Italy is against purchase of rice and during last five years European Union has rejected several of our food products in more than 800 different cases. This rejection is totally based on high amount of pesticide residues on our products and non-compliance of International standards about pesticides residues. The world population is expected to rise to 12 billion by the year 2030. It is a big dilemma to feed such a large population. Agricultural biotechnology will play a major role in resolving this problem. More than 30 countries of the world are growing GM crops on more than 400 million acres of land. This includes both developed and developing countries like USA, China, Brazil, Canada, Argentina, India, South Africa etc. India allowed commercialization of Bt cotton ten years ago. Today more than 10 million hectares of land is under cotton cultivation and 92% of the total area is under Bt cotton. India became an exporter of cotton from importer of this fibre. Yet there is a vocal opposition by minority while silent majority watches in dismay. Anti GM activists are vehemently opposing the use of this technology for other crops. Three years back India did not permit the commercialization of Bt brinjal which was a big blow to use of biotech for improvement of crops. In spite of the fact that several scientists were involved and lot of money was spent on risk analysis, Bt brinjal did not win the approval of regulators in India. The squeeze is still demoralizing Indian scientists as they are not getting enough funds for research in this field and may be left far behind in the skills in this technology. Today more than 400 million acres of land in some thirty different countries grow GM crops. Over three trillion servings of food have been consumed without any harm to human health. For last 20 years' experience with GM crops, there has not been a single confirmed incidence of harm to human health or disruption of ecosystem. A doubt has been raised that use of GM maize in USA has increased the incidences of allergy cases. A report from Colorado State University, USA published by F. B. Paeirs (Aug. 2010) states that Delta endotoxins and vegetative insecticidal protein (VIP) produced by the currently available events are all broken down in the stomach of humans and thus are not potential allergens. A feature article in NATURE entitled, "How Safe Does Transgenic Food Need To Be" by Laura DeFrancesco, Senior editor of Nature-Biotechnology has clearly described that transgenic crops are the most highly regulated foods in the world. Citing the example of genetically modified sweet corn which has been the part of American diet since 1998 when SYNGENTA'S insect protected corn was approved, no untoward health effect has been reported since then (Nature-Biotechnology, Vol.31 No. 9 Sept. 2013).A review article, "An overview of last ten years of genetically engineered crop safety research by Alessandro Nicolia et.al published in Informa healthcare, 2013 clearly states that scientific research conducted so far has not detected any significant hazards directly connected with the use of GE. The grounds on which anti GM activists protest are cynical based on unfounded skepticism. Many such anti GMO activities are influenced by financial support from industries that has developed a paranoia for sale of their product. It has become a vicious game derived by loud screaming minority while silent majority and rural communities suffer in a deteriorating pesticide and fertilizer run off environment where a clean glass of drinking water is hardly affordable. This game promoted by few has killed our conscious and reconstructed our character. The anti GM activity and moratorium was largely based on a publication by Gilles-Eric-Seralini that claimed to show that genetically modified corn could lead to a high incidence of cancer. In a stunning development, Journal of FOOD and CHEMICAL TOXICOLOGY, which published this controversial rat study RETRACTED this publication and evidence of it expunged from the Journal's database. Bowing to scientists' near universal scorn, Journal of Food and Chemical Toxicology has retracted a controversial paper (G.E. Seralini et.al., Food and Chemical Toxicology, 50: 4221 - 4231: 2012) that claimed that Monsanto's genetically modified corn causes serious disease in rats. The author has earlier refused to withdraw it. The paper showed no evidence of fraud or intentional misrepresentation of the data. Said a 28thNovember 2013 statement from publisher's Elsevier but the small number and type of animals used in the study mean that "No definitive conclusions can be reached. Though transgenic crops are not the final answer to all our agricultural problems. At present one cannot ignore this sunrise technology which has revolutionized the world agriculture by improving yield and making them more nutritious. Organic farming though safe when practiced on a large scale cannot meet the food requirement of highly progressing population of our country. Introduction of a foreign gene simply helps to achieve its full potential and productivity without any yield loss due to stress. The game is between carcinogenic pesticides V/s GMO. The choice is between GMOs and toxicity of pesticides. It's now the Indian public who will decide whether to eat food loaded with pesticide residues or eat healthier, nutritious and flavorful food. Beneficiary of new technology are people. Pesticides do not discriminate people, then why should technology? ]]> <![CDATA[Five projects funded under Indo-Brazil collaboration ]]> https://biospectrumindia.com/news/95/4676/five-projects-funded-under-indo-brazil-collaboration-.html https://biospectrumindia.com/news/95/4676/five-projects-funded-under-indo-brazil-collaboration-.html Wed, 08 Jan 2014 13:40:56 +0530 The research and development (R&D) proposals approved for support against the Indo-Brazil joint call for proposal (2013-16) by DBT and CNPq include few interesting topics in various areas of biotechnology. There are three projects in the area of biomedicine. The first one is of the investigators/ proposal title area Dr. K Satyamoorthy and Prof. Raghuvir K Arni on functional and structural characterization of snake venom proteins with angiogenic potential from Bothrops atrox. The second one is being undertaken by Dr P Yogeeswari and Prof DiÃ³genes Santiago on the project 'Santos Enzymes from Purine and Pyrimidine Biosyntetic pathway as targets for the development of Mycobacterium tuberculosis drugs,' The third project in biomedicines is being spearheaded by Dr Suresh Korpole and Prof OctÃ¡vio Luiz Franco for the project on 'Antimicrobial recombinant peptides and lipopeptides production for treatment of nosocomial infections.' Under the bioenergy vertical, the project on 'synthesis of bioethanol from sugarcane bagasse in a membrane - Integrated Hybrid System - A Green Technology Approach' is being undertaken by by Dr Jaya Sikder from India and Silvio SilvÃ©rio da Silva form Brazil respectively. The project under nanotechnology vertical is carried out by Dr Arunava Goswami and Prof. JosÃ© Paulo Gagliardi Leite. The same is focussed on 'Rotavirus detection with novel nano tools nranotechnology.' ]]> <![CDATA[Delhi to host medical tourism seminar ]]> https://biospectrumindia.com/news/95/6327/delhi-to-host-medical-tourism-seminar-.html https://biospectrumindia.com/news/95/6327/delhi-to-host-medical-tourism-seminar-.html Wed, 08 Jan 2014 11:21:26 +0530 The seminar is expectedto serve an innovative platform that will bring across common interests among people of various professions. The organizers cal it as one of the mega events that will unveil and revolutionize the opportunities in the field of medical tourism. As per them, it is for the first time that more than 500 visitors, 35 reputed doctors and 6 panelists come at a common platform in order to discuss about medical tourism as an industry. Some of the distinguished people who will be present on the day of the event include Mr Ashok Seth, chairman, Fortis Escorts, Dr V S Venkatesh, CEO, Apollo White Dental, Dr Vijay Kataria, head of emergency, St. Stephen Hospital, Kiran Bedi, Harendar Singh, former hockey coach, Dr Tarang Gianchandani, CEO, Jaslok Hospital, Mumbai, Dr Harish Joshi, spiritual healer, Indian Spiritual Healing, Dr Anil Aggarwal president, Delhi Medical Association, Dr Girish Tyagi, secretary, Medical Council and many more. Not only this, the Seminar is one of the biggest event organized to bring forth the right knowledge in medical tourism. The doctor's and the Panelists are renowned and possess the right kind of expertise to help people understand the prospects of Medical Tourism India. UNLOCK truly aims to create an ecosystem of like-minded people who feel the need to redefine the ecosystem of Medical Tourism and also bind together direct and indirect players in this genre. Mr Vishal Salhotra ,managing director, UNLOCK says, "India's Medical Tourism Sector is expected to grow by 30% making it a $2 million dollar industry by 2015. An estimated 1, 50,000 of people travel to India every year for health treatment, spawning a colossal industry of today. The Seminar is organized to enlighten many others about such a promising Industry like Medical Tourism which is bound to mushroom and get organized with each passing day. Within this segment, India seems to be joining the dots by not only attracting patients from across the globe but also takes pride in helping people looking for alternative treatments, spa and wellness centres etc. The event will streamline many such discussions and will address the Myths". The expert panel include Dr Vijay Kataria, (Head of Emergency, St. Stephen Hospital, New Delhi); Dr Ravinder K. Tuli, (Senior Consultant Holistic medicine, New Delhi); Dr Anil Rastogi, (Director Marketing, Synergy Group); Dr Rashmi Sharma, (Director, Origyn Fertility & IVF, Max Hospital, New Delhi); Harvinder Mathur, (Chairman, Expertise India Pvt. Ltd., New Delhi); Dr M B Prabhu, (Acupuncturist, Sai Acupuncture Research Centre, GOA); Dr Tarang Gyanchandani, (CEO & Director Medical Services, Jaslok Hospital & Research Centre, Mumbai) and Rahul Mishra, (Head-Special Projects, V2 Motion Picture Pvt. Ltd., Noida, Uttar Pradesh) ]]> <![CDATA[Samsung's first premium ultrasound with 5D technology ]]> https://biospectrumindia.com/news/95/5208/samsungs-first-premium-ultrasound-with-5d-technology-.html https://biospectrumindia.com/news/95/5208/samsungs-first-premium-ultrasound-with-5d-technology-.html Wed, 08 Jan 2014 11:12:00 +0530 Samsung Electronics has launched the UGEO WS80A, its first premium ultrasound with 5D technology in India. The device features a 21.5â€³ wide LED imaging screen and a 10.1â€³ touchscreen for the controls, as well as a variety of software optimizations that help resolve relevant anatomy and outputs data to 3D TV's for an even more realistic view. "As the first premium device, the UGEO WS80A represents the latest ultrasound innovation and leading IT technologies of Samsung," said Dinesh Lodha, vice president, Health and Medical Equipment Business, Samsung India. "Samsung will continue to put its best efforts towards developing medical devices that deliver true-to-life images and features that provide faster diagnosis." The new UGEO WS80A combines Samsung's latest technology in display to deliver faster and more accurate diagnoses in the field of women's health. Its key features include the 21.5" Wide LED screen offers users higher quality color image representation as well as higher resolution compared to conventional monitors, delivering enhanced vision of the ultrasound images. Apart from that a 10.1" Touch Control Pad is highly sensitive, allowing for easy input to minimize users' stress from pressing the buttons. The FRV + Inversion Mode - FRV(Feto Realistic View) has been upgraded to improve speed and to support inversion mode. Advanced FRVTM allows for detailed visualization of subtle anatomical features, thereby enabling intuitive diagnosis on the scanned 3D images and enriching patient communication. 5D NT (Nuchal translucency)* -- Enables realistic visualization of NT images that help detect Down syndrome. 5D CineTM -- Provides images that can be viewed on 3D TV for healthcare practitioners to acquire new clinical value through more accurate diagnoses of lesions and blood vessels. Apart from the clinical benefit, this feature also gives life-like 3D images of the unborn child. ElastoScan - applies strain imaging technology which displays the gradient value of tissue displacement via color map, thus making it easier for users to differentiate between benign and malignant masses through acquiring the strain ratio between the target and reference area at a much faster rate than its predecessors. Simple ROI selection and automatic calculation make breast diagnosis more efficient and intuitive. Other additional features include the Additional EV Probe Holder, Probe Cable Hangers, Default Gel Warmer and Up & Down Lift that allows the user to adjust the system to the user's preferred height without straining. ]]> <![CDATA[Venus medicine research centre signs MoU with Baba Farid varsity]]> https://biospectrumindia.com/news/95/3558/venus-medicine-research-centre-signs-mou-with-baba-farid-varsity.html https://biospectrumindia.com/news/95/3558/venus-medicine-research-centre-signs-mou-with-baba-farid-varsity.html Tue, 07 Jan 2014 18:24:02 +0530 The Venus Medicine Research Centre (VMRC), the research wing of Venus Remedies in Baddi which has been accredited for good laboratory practices (GLP), has signed a Memorandum of Understanding (MoU) with Baba Farid University of Health Sciences (BFUHS), Faridkot to undertake collaborative research projects and academic programes. Dr (Mrs) Manu Chaudhary, director, research, VMRC, signed the MoU with Dr SS Gill, vice- chancellor BFUHS in the presence of Dr Praveen Bansal, director, research, BFUHS; Mr Satpal Singh, joint registrar, BFUHS, and Dr Renu Bansal, associate professor, department of microbiology, Guru Gobind Singh Medical College, a constituent of BFUHS. Speaking about the scope of the new agreement, Dr Chaudhary said, "We have found just the right partner in BFUHS to take our research work forward. Together the VMRC and BFUHS will open new frontiers for high-end research in India, particularly in the fields of oncology, anti-infectives and pain management." The VMRC already has research collaborations with University of Illinois, Chicago; Institute of Microbial Technology (IMTECH), Chandigarh; Department of Microbiology, Panjab University, Chandigarh; the National Institute of Pharmaceutical Education and Research (NIPER), Mohali; Guru Jambeshwar University of Science and Technology, Hisar; Procdane Institute of Pharmaceutical Sciences, Hyderabad; Sri Ram Medical College, Chennai; Gandhi Medical College, Hyderabad; King George Medical College, Lucknow and Amity University, Noida. ]]> <![CDATA[Masimo Corp brings hi-tech products to India]]> https://biospectrumindia.com/news/95/6285/masimo-corp-brings-hi-tech-products-to-india.html https://biospectrumindia.com/news/95/6285/masimo-corp-brings-hi-tech-products-to-india.html Tue, 07 Jan 2014 15:56:00 +0530 On January 7, 2014, California-based Masimo Corp, manufacturer of non-invasive patient monitoring technologies announced that it will be opening its offices across India to meet the health demands of the burgeoning Indian market. Commenting about Masimo's expansion in India, Mr Jon Coleman, president, Masimo Worldwide Sales, Professional Services and Medical Affairs, said, "We have found that India is a an important market for several reasons - the most important is that the penetration of high technology devices is very low, a factor that could lead to thousands of avoidable instances of death and illness. Masimo's technologies will be able to make a significant impact to improve patient safety and outcomes." Masimo in its official announcement said that it has obtained technology license and OEM agreements with leading patient monitoring manufacturers spanning the globe, including Atom, Datascope, GE Medical, Medtronic, Philips, Spacelabs, and Zoll. ]]> <![CDATA[Masimo Brings High Technology Medical Equipment to India]]> https://biospectrumindia.com/news/95/1563/masimo-brings-high-technology-medical-equipment-to-india.html https://biospectrumindia.com/news/95/1563/masimo-brings-high-technology-medical-equipment-to-india.html Tue, 07 Jan 2014 15:43:47 +0530 Masimo, the inventor of breakthrough noninvasive patient monitoring technologies, today announced the opening of offices across India to meet the health demands of the burgeoning Indian market. Masimo have steadily increased in the last five years, has technology license and OEM agreements with leading patient monitoring manufacturers spanning the globe, including Atom, Datascope, GE Medical, Medtronic, Philips, Spacelabs, and Zoll. "We have found that India is an important market for several reasons - the most important is that the penetration of high technology devices is very low, a factor that could lead to thousands of avoidable instances of death and illness. As a leader in noninvasive patient monitoring, including measure through motion and low perfusion pulse oximetry, Masimo's technologies will be able to make a significant impact to improve patient safety and outcomes," said Mr Jon Coleman, President, Masimo Worldwide Sales, Professional Services and Medical Affairs. Masimo is working with India's top medical and nursing practitioners to raise greater awareness of the clinical and cost challenges that Masimo's innovative technologies can solve. Masimo SET Measure-through Motion and Low Perfusion pulse oximetry. Compared to other pulse oximeters during patient motion and low perfusion, Masimo SET provides measurements when other pulse oximeters cannot, dramatically reduces false alarms (specificity), and accurately detects true alarms (sensitivity) that can indicate a deteriorating patient. Most importantly, Masimo SET pulse oximetry has been shown to improve patient outcomes by helping clinicians reduce retinopathy of prematurity (ROP) in neonates, screen newborns for critical congenital heart disease (CCHD), reduce ventilator weaning time and arterial blood gas measurements in the ICU,and save lives and costs while reducing rapid response activations and intensive care unit transfers on the general floor.Local response from the clinical community has been overwhelming. "I've been using Masimo technology for the last three years or so and am very happy to hear about Masimo's commitment to the region," said Dr Anil Karlekar, executive director and head of anesthesiology and critical care at Fortis Escorts Heart Institute in New Delhi. "I look forward to closer collaboration with the Masimo India team." Root, a powerful new patient monitoring and connectivity platform that integrates breakthrough rainbow and SET measurements with multiple additional parameters-including SedLine brain function monitoring and Phasein capnography and gas monitoring. Root includes a dock for the Radical handheld Pulse CO-Oximeter and acoustic respiration rate monitor, an instantly interpretable display, and multiple networking/connectivity options. Root integrates multiple streams of data and simplifies patient care workflows, empowering caregivers to help make quicker patient assessments, earlier interventions, and better clinical decisions; and â€¢Masimo Patient SafetyNet, a remote monitoring and clinician notification system clinically shown to keep patients safer by enabling remote continuous monitoring of the patient's physiology, including oxygenation and pulse rate, which has led to saved lives, reductions in rapid response activations and transfers to intensive care units. "I'm glad to learn that Masimo has arrived in India through its own sales and clinical team," added Dr. Kartik Nagesh, head of neonatology at Manipal Hospital in Bangalore. "We have been using Masimo technology in our NICU for some years and now with a local presence we are more confident about our ability to improve quality of care to our neonatal patients." ]]> <![CDATA[Apollo Hospitals introduces Teleradiology remote consulting and diagnostic services ]]> https://biospectrumindia.com/news/95/6687/apollo-hospitals-introduces-teleradiology-remote-consulting-and-diagnostic-services-.html https://biospectrumindia.com/news/95/6687/apollo-hospitals-introduces-teleradiology-remote-consulting-and-diagnostic-services-.html Tue, 07 Jan 2014 14:48:26 +0530 In yet another feat to take world class healthcare in India, Apollo Hospitals today launched a superior remote consulting and diagnostic -Teleradiology services at its Flagship Hospital in Chennai. Inaugurated by Dr A.P.J Abdul Kalam, honourable former President of India. This technology intervention will help patients and diagnostic centres in remote locations to access expert radiologist with their radiology images for expert opinion and get appropriate treatment recommendations. The service will play a very vital role in reducing patient waiting time for diagnosis, treatment commencement and cost. Teleradiology is an emerging field that has the potential to benefit both patients and healthcare service providers immensely as it helps eliminate distance barriers and improve access to quality health services or information that otherwise are not available in rural and distant communities. They play an invaluable role in emergency and critical care situations especially where moving a patient may be undesirable or not feasible. Not only does this technology lessen the inconvenience and cost of patient transfers but will also help reduce unnecessary travel time for health professionals to multiplex their services beyond boundaries where by improve efficiency and to reduce cost. "Since three decades we have been innovating on our facilities and introducing new technologies to better healthcare reach and administration. Teleradiology as a technology can transform rural healthcare delivery by empowering both patients and doctors alike. While rural practitioners can gain access to specialist health services and benefit from interactions with consultants and specialists, patients can receive health information and advice from health professionals from the convenience of their homes." said Dr Prathap C Reddy, chairman, Apollo hospitals Group. Without rapid access to medical imaging results, diagnosis and treatment delays would be the norm of the day and the cost of care would be even greater. The advantage of having a Teleradiology group is that it can provide a team of specialized teleradiologists for patients, and moreover, emergency services are also provided effectively, bringing down the waiting time for patients. The Teleradiology group has several specialties and sub-specialties available such as Neuroradiologists, Musculoskeletal radiologists, Abdomen and Pelvic imaging specialists, Woman's imaging specialists and Cardiac radiologists. When the scans are sent to the group, the group assigns the reporting to the specialists, thereby the hospital treating the patient gets the best specialist report in that particular speciality. ]]> <![CDATA[Syngeta's takeover of Devgen complete]]> https://biospectrumindia.com/news/95/3112/syngetas-takeover-of-devgen-complete.html https://biospectrumindia.com/news/95/3112/syngetas-takeover-of-devgen-complete.html Tue, 07 Jan 2014 10:51:00 +0530 Rice is critical to global food security and Syngenta's strategy has been to accelerate investement in rice breeding to increase yields. Devgen has premium rice hybrids which will bring immediate benefits to growers when brought together with Syngenta's crop protection portfolio. In the letter dated December 12, 2013 sent to the BioSpectrum, Dr K C Ravi, vice president, Commercial Acceptance and Public Policy, South Asia, mentioned, "The complementarity between Syngenta's global technology platforms with Devgen's expertise in beerding, R&D and production will broaden the rice pipelines as well as further enable the development of integrated solutions for the benefit of the farming communities. Devgen's crop portfolios in sunflower, sorghum, pearl millet and cotton will also offer new options for growers in Southy Asia. Devgen's research in RNAi technologies will help Syngenta expand offerings in insect control solutions in a range of crops. Furthermore, nematode control is an increasing problem for growers in rice and Devgen''s nematicide is expected to ahelp in addressing the critical problem for rice growers. "The acquisition is the biggest in Syngenta's history and is exciting for both companies. It will offer everyone increased opportunities for personal and professional growth through working with new colleagues, sharing knowledge and learning insights. And most importantly it will help to address the problems of numerous growers accross India and South Asia," concludes the letter. ]]> <![CDATA[BioSpectrum announces hits and misses of 2013: A Flash Back]]> https://biospectrumindia.com/news/95/4376/biospectrum-announces-hits-and-misses-of-2013-a-flash-back.html https://biospectrumindia.com/news/95/4376/biospectrum-announces-hits-and-misses-of-2013-a-flash-back.html Mon, 06 Jan 2014 16:33:00 +0530 The Indian BioScience industry witnessed tremendous highs and lows in 2013. Specifically, the pharmaceutical industry took most of the beating, owing to regulatory woes within the country and import bans from foreign bodies. However, in terms of new innovation and products developed, India made many heads turn in the global market towards itself. Major collaboration and acquisitions were a continuous integral part of many Indian companies. Here is an exclusive sneek-peek of the significant events in 2013: Cabinet nod for establishment of National Cancer Institute Being set up at the cost of Rs 2,035 crore, the National Cancer Institute (NCI) is expected to cater to requirements in northern India. This is a landmark step in the arena of cancer research in the country and shall lessen the deficit of tertiary cancer care in the Northern region. Cancer is emerging as a major public health concern in India, where every year 11 lakhs new cases are diagnosed, with a mortality rate of 5.5 lakhs per year. Shackled in India, Bt Brinjal gets free run in Bangladesh While the Bt brinjal issue in India continues to remain tangled in the political and legal systems, Bangladeshis have decided to take the plunge. It may sound positive for the industry, activists feel otherwise. The top regulatory authority in Bangladesh, the National Committee on Biosafety (NCB), has given its approval in November, 2013, to the commercial cultivation of the Bt brinjal, making it the country first in South Asia to allow the entry of any edible genetically modified (GM) crop in its market. Doctors to receive real time medical updates With the introduction and implementation of remote access informationdevices that are accessible and has the ability of interoperatibility from any remote place and transmit data at any given time will result in saving lives in case of emergency situation. Prisma Global limited introduces a product called Medibox or MDS3. GE Healthcare to invest $2 bn in software development GE Healthcare announced its plans to invest $2 billion over the next five years to accelerate the development of innovative software for healthcare systems and applications. Over next five years, the company will focus on advancing current and future technology offerings through the convergence of machine and intelligent data known as the industrial internet. It is the age of 'Digital Patient', says Quintiles A new report by Quintiles has indicated that sponsor companies that can successfully engage with the digital patient will distinguish themselves and increase their probability of success. Quintiles has suggested that aligning activities such as patient recruitment, collection of medical data with the digital environment will streamline product development, prove product value and accelerate product adoption. UK partners with BioAsia to bolster ties in biotechnology On November 29, 2013, the United Kingdom partnered with BioAsia as the Principal Country Partner for the 11th edition of the event, BioAsia 2014, to be held in Hyderabad from February 17-19, 2014, at the Hyderabad International Convention Centre. Novozymes opens world's first advanced biofuels facility in Italy On October 9, 2013, Novozymes and Beta Renewables officially opened the world's largest, second-generation biofuels facility in Crescentino, Northern Italy, estimated to produce 75 million liters of cellulosic ethanol annually, from agricultural waste. Beta Renewables is a leader in producing cellulosic biofuels and a part of the Mossi Ghisolfi Group, and Novozymes. Indian government backs generic drug industry In light of the controversy regarding the quality of generic drugs produced in India, the government has issued a statement that supports the industry whose majority exports are to regulated markets and is 4th in the world in terms of production. The Government of India has come forth with an assurance about the drugs being manufactured in India being subject to scrutiny by various agencies. FDA finds hair, oil spots on tablets at Ranbaxy's unit Last year, during USFDA's visit to Ranbaxy's Laboratory facility, inspectors found a black 'hair' particle in a tablet, possibly suspected to have fallen from an employee's arms. Post this incident, the USFDA became highly alert and imposed an import alert on its Mohali plant, stating that the drugmakers manufacturing units were not up to the industrial standards. India pharma receives highest FDI worth $1 billion The Indian pharmaceutical industry has received US $1 billion as FDI (Foreign Direct Investment) - the highest among top 10 segments, during April-June this year. Back in April-June 2012, the Foreign Direct Investment (FDI) in the drugs and pharmaceutical industry was at $465 million, according to the latest data of Department of Industrial Policy and Promotion (DIPP) Dr Reddy's Laboratories sued over cancer drug patent Sanofi-Aventis' fully owned subsidiary - Genzyme Corporation, has filed a suit against Dr Reddy's Laboratories, alleging that it has infringed on patents of its cancer drug Mozobil (Plerixafor injection) on three counts. Praj becomes first to set up 2G cellulosic ethanol plant South Asia's first second generation cellulosic ethanol demo plant by Praj Industries, will enable development of the entire value chain including biomass impact on the captital as well as operational. The demo plant will enable Praj to consolidate its 6 years of R&D efforts, starting with laboratory trials to pilot scale trials. The same plant will also enable Praj to develop various biochemicals and bioproducts. Biocon ranked 6th in top twenty biopharma employers list On October 25, 2013, Biocon Ltd, announced that it has been ranked at 6th position by Science Magazine, on the annual global 'top twenty employers' list in the biopharma sector. This is a major leap for the company from its 19th place in 2012. Ranbaxy receives CDSCO approval to market Synriam in India Ranbaxy Laboratories has received approval from CDSCO to manufacture and market Synriam (arterolane maleate and piperaquine phosphate tablet 150+750 mg) in India. Strides Arcolab receives USFDA approval for its Italian facility Strides Arcolab announced that it has received USFDA approval for its Beltapharm's facility (a subsidiary of Strides Arcolab) located in Milan, Italy. This state-of-the-art, EU and TGA (Therapeutic Goods Administration, Australia) approved facility located in Milan, Italy, manufactures liquids, semi-solids, ointments and creams. MSD and Lupin announce strategic partnership In an important development, MSD, one of the world's starring players in 23-valent Pneumococcal Polysaccharide Vaccines category, and Pharma leading Lupin Limited (Lupin) today announced the forming of an India-specific strategic partnership. A recent survey from India showed that the case fatality rate due to invasive pneumococcal disease observed in elderly is 26.4% which is much higher than that in children and highlights the demand for preventive interventions in adults. Cipla India takesover Medpro South Africa Cipla has announced an offer to the shareholders of Cipla Medpro South Africa to acquire 100% of the ordinary share capital of Medpro for $1.13 per share. The offer will be implemented via a scheme of arrangement and is subject to regulatory and other approvals including approval by Medpro shareholders. The total consideration payable by Cipla is approximately USD 512 million. Bharat Biotech develops indigenous JE vaccine Said to be much effective and safe over attenuated vaccines against Japanese encephalitis disease, Bharat Biotech's JENVAC has proved its long term protection ability during clinical studies. The vaccine was launched at New Delhi on October 04, 2013. The biggest advantage of JENVAC over live attenuated vaccines is that this vaccine could be administered even during an epidemic as it is an extremely purified and inactivated vaccine. Monsanto faces biopiracy case India's first ever biopiracy case has been filed in Karnataka against Monsanto by ESG (Environment Support Group), a non-profit organization involved in environmental and social justice, for infringing the country's Biological Diversity Act. It is alleged that endemic varieties of Brinjal were accessed by UAS (University of Agricultural Sciences), Monsanto and Mahyco. After which, Monsanto's proprietary Bt Gene were inserted in the local varieties of Brinjal to create the Genetically Modified Bt Brinjal. India faces shortage of Yellow Fever vaccine While India is free from Yellow fever disease, the citizens traveling to affected countries have to be immunized. In view of the interruption of regular supply from CRI, K and anticipating the crisis situation, Sanofi Pasteur (the only company which has DCGI approval, but for single dose vaccine vial) was approached for supply of 60,000 doses (10 dose vial) in April, 2013. It was mentioned that, Sanofi Pasteur does not have license for multi-dose vial, it will have to get DCGI approval for Govt of India supply order. ]]> <![CDATA[50 Biotech US IPOs in 2013 - Offer encouragement for India's biotech industry]]> https://biospectrumindia.com/news/95/5282/50-biotech-us-ipos-in-2013-offer-encouragement-for-indias-biotech-industry.html https://biospectrumindia.com/news/95/5282/50-biotech-us-ipos-in-2013-offer-encouragement-for-indias-biotech-industry.html Mon, 06 Jan 2014 16:16:02 +0530 In the year 2013 Biotech sector in the US saw a record offering of over 50 IPOs that raised approx. 7.5 billion USD. The numbers were impressive by any standards and should give companies in the sector ample reason to cheer. But the fact remains that most of the action happened in the US, with a few IPOs in Israel. The Indian Biotechnology industry has been growing at a healthy clip and accelerating towards the anticipated 100 billion USD by 2025. That would of course need a growth rate of 30 -35%, which seems to be difficult task at a time when there are a quite a few fundamental issues, both at the macro and micro level. Biotech leaders in India will meet during 'BIOINVEST 2014'in Mumbai on January 24, 2014 to bring together on one platform lifescience companies, institutional investors and investment bankers to explore opportunities for investment in biotechnology sector for the next 5 years. Some visible trends including big data and manufacturing particularly biologics, may offer solutions for the growth of the sector. The conference will also focus on skill development and education as the main pillars for the industry to grow. The recent announcement of a 1 billion USD investment by a Pharma MNC is definitely encouraging and goes to prove that India remains an attractive investment destination despite challenges. In the past, a significant investment in the drug discovery space by a Japanese major also bodes well for India's capabilities. As per Dr PM Murali, president, ABLE, "The Indian biotech sector holds the potential to address various challenges including healthcare, agriculture and pharma and BIOINVEST conference aims at finding the right path of growth for the sector by bringing together the industry to debate and discuss on the potential offered by the biotech sector. Also, the new environment minister Mr Veerappa Moily is now considering approval for GM crops. This is a very good sign for attracting investment into the agriculture sector." ]]> <![CDATA[Lilavati Hospital wins 'India's Best Multi Speciality Hospital' award ]]> https://biospectrumindia.com/news/95/8044/lilavati-hospital-wins-indias-best-multi-speciality-hospital-award-.html https://biospectrumindia.com/news/95/8044/lilavati-hospital-wins-indias-best-multi-speciality-hospital-award-.html Mon, 06 Jan 2014 16:15:29 +0530 Lilavati Hospital, regarded among the best tertiary care hospitals in the country, has been honored once again as 'India's Best Multi Specialty Hospital- Megapolis' in 'India Healthcare Awards 2013' at a ceremony held recently in New Delhi. The event was presided by Mr Montek Singh Ahluwalia, Deputy Chairman - Planning Commission of India. CNBC-TV18 in partnership with ICICI Lombard instituted the India Healthcare Awards to honor and recognize India's best healthcare providers. Dr Narendra Trivedi, coo at Lilavati Hospital said, "We treat common class patients at par with treatment given to celebrities and VIPs. Lilavati Hospital is preferred by all." The social service wing of the hospital- SEWA serves to the health requirements of needy people. This department seeks to bridge the gap between the needy patients and the fast evolving medical technology. Various social activities such as free OPD, services to senior citizens, sending mobile vans to organize free health check-up camps at different locations within and outside Mumbai are undertaken as an on-going process. "We at Lilavati Hospital believe that we should endeavor to be the best of the best. We are humbled to receive this award but we will work doubly hard to be one of the best in the world and put India on the list of the best hospitals in the world" said Mr Chetan Mehta, trustee, Lilavati Kirtilal Medical Trust. ]]> <![CDATA[Quest Diagnostics extends cancer testing services across India]]> https://biospectrumindia.com/news/95/5909/quest-diagnostics-extends-cancer-testing-services-across-india.html https://biospectrumindia.com/news/95/5909/quest-diagnostics-extends-cancer-testing-services-across-india.html Mon, 06 Jan 2014 15:34:18 +0530 Quest Diagnostics India has expanded the ability to access cancer diagnostics services following a successful pilot of the introduction of these services to patients and oncologists in New Delhi. Now, the company has expanded its marketing, service and logistics operation in order to provide cancer testing services to 25 metros and Tier I cities across the country, including Delhi, Mumbai, Bangalore, Kolkata, Hyderabad, Ahmedabad and Kochi. Quest Diagnostics, headquartered in the United States, provides the services in India through its full service laboratory in Gurgaon, India and esoteric testing laboratories based in the United States. Recently introduced services include testing to help detect hematological, or blood, cancers using next-generation sequencing, an advanced technique that identifies mutations and variants in an individual's DNA or genome. Another service is a test that assesses the ROS1 gene mutation status to help determine a patient's response to a certain lung cancer therapy. The company also provides testing for breast, cervical, prostate, soft tissue, bone and several other cancers. "The incidence of cancer cases is on the rise in India. Today, patients and the treating physician need accurate and reliable diagnostic insights in order to make the right treatment decision," said Mr. Mukul Bagga, managing director, Quest Diagnostics India."The most exciting and important advances in cancer diagnostics are occurring in the field of genomics and molecular testing. Yet, technology and expertise constraints can limit access by clinicians and patients in India. Clinicians and patients in major cities of India can now access the international experience and clinical operations of Quest Diagnostics, the world leader in diagnostic information services, including cancer testing, in India and the United States." Quest Diagnostics started operations in India in 2008, with its state-of-the art 65,000 sq. feet laboratory in Gurgaon, Haryana. Since then it has provided a broad spectrum of testing services in cardiology, gynecology, endocrinology, infectious diseases among others. In April 2011 it began a pilot program to provide cancer diagnostic services from its U.S. and Gurgaon labs to patients in the New Delhi/ National Capital Region. In India, Quest Diagnostics has been first to offer many path-breaking diagnostic testing services in cancer, such as Pap by liquid-based cytology for screening cervical cancer and Leumeta, proprietary plasma based test for leukemia Quest Diagnostics India has also been one of the pioneers in the field of digital pathology to benefit cancer patients. The advanced digital pathology platform is used to exchange medical information and seek the expert opinion from among a panel of600 organ-focused Quest experts based in the United States. Data reported at the recently held Indian cancer congress - a retrospective review of 500 cancer cases that were referred for an expert opinion revealed that 40% had their original treatment protocols changed after review of those cases by the panel of Quest experts. "This service not only helps the clinician but also the patient because it provides an extra measure of quality based on expertise of our U.S. colleagues." said Mr. Mukul Bagga. Cancer incidence and mortality has been steadily rising with 979,786 cases diagnosed in India in year 2010 to 1,148,757 cases projected by 2020 (APJCP 2010; 11(4): 1045-9). Also as per national representative survey, published in Lancet 2012, May edition, the mortality due to cancer in India was found to be 556,400 cases in 2010. The need of the hour is early detection and prevention as well as accurate diagnosis and monitoring. ]]> <![CDATA[Pharma industry grew by 13% during FY 09-13 says Dun & Bradstreet report]]> https://biospectrumindia.com/news/95/3551/pharma-industry-grew-by-13-during-fy-09-13-says-dun-bradstreet-report.html https://biospectrumindia.com/news/95/3551/pharma-industry-grew-by-13-during-fy-09-13-says-dun-bradstreet-report.html Mon, 06 Jan 2014 15:19:00 +0530 According to the outlook report outlook on 'Pharma Industry' for 2014 by the Dun & Bradstreet, the Indian pharma industry has exhibited a stellar performance in the past and has grown unabated at an estimated CAGR of ~13% during FY 2009-13. Both, domestic and export led demand contributed towards the robust performance of the sector. Lower cost of production and availability of highly skilled labor pool at low cost has helped Indian pharmaceutical companies to innovate and develop generic substitutes of patented drugs at a fraction of cost incurred in developed markets. Though the pharma industry has remained shock proof to recession in the past, currently companies in this sector are also facing the heat of slowing economic growth. The domestic economy continued to grow at a subdued GDP growth rate of 4.7% during first three quarters of 2013 as against 5.2% in the previous year period. The cumulative sale for first nine months of CY2013 grew by just 9% against 17.4% in the previous year. Moreover, the industry is facing stringent regulatory and quality norms both at global and domestic front. Increasing government intervention is expected to impact industry's performance in the near term; however such interventions are necessary to bring India at par with global standards. Some of the key developments influencing the industry performance in CY2014 include: Implementation of New Pricing Policy is likely to translate in weak domestic revenue generation: Implementation of Drug Policy Control Order (DPCO) 2013 by New Pharmaceutical Pricing Authority (NPPA) with effect from 15th May 2013, which put a cap on the prices of 348 essential drugs, is likely to impact domestic revenue generation of both home grown and multinational drug manufacturers in CY2014. Impact of New drug pricing policy and regulatory intervention has already started influencing the growth performance of the overall pharma industry. Slowing quarterly net sales growth to 9% and 12% during Q2 & Q3 of CY2013 (period during which DPCO was implemented) respectively against 15% plus growth during the same period in previous year well reflect the impact of DPCO as well as slowdown in demand. Compliance to this regulation may continue to create the pressure on pharma companies' profitability in 2014. Imposition of Quality Issue Norms by the respective US and UK regulating authorities likely to impact export performance: India is one of the largest exporters of pharmaceutical products in the US & European region. The US and the Europe account for 25% and 7.0% share respectively of pharmaceutical exports of India. The share of exports revenue in total industry revenue has increased to more than 50% in FY13 from 42% in FY09. India has the largest number of US FDA approved facilities (currently 169) outside the US which points to the quality standard achieved by Indian pharmaceutical companies. However, currently pharmaceutical exports from the country are plagued by quality issues, primarily in the US market. There have been multiple instances of product recall from the US market in past couple of years. The recent adverse rulings by US FDA are expected to impact the export of pharma products from the country which has reported a phenomenal growth of over 19% during the period FY 2009-13. In the light of these adverse rulings, US FDA might impose tighter quality norms which would delay Indian pharmaceutical companies launching their products in the US market. Since the US is the largest export market for Indian pharmaceutical companies, any delay in exports to the US due to adverse rulings by the regulating authorities would have a significant impact on the sector. Hike in US FDA generic drug user fee is expected to hit hard the Indian drug manufacturer too In August 2013, US FDA hiked the generic drug user fee sharply for generic drug with a view to reduce the backlog of pending applications and cut down on the average time required to review generic drug applications for safety. However, this hike is likely to put financial burden on generic drug manufacturer across the world while its impact on India is likely to be felt in a big way as it is the second largest exporter of generic drug to US holding a 10% share in US generic drug market.Enactment of Proposed Bill 'Small Manufacturer Protection Act of 2013' in US may benefit small generic drug player including Indian manufacturers. On 2nd December 2013, Small Manufacturer Protection Act of 2013' was proposed in the House of Representative. This bill has been proposed in order to protect small generic drug manufacturers against the recent hike announced by US FDA in the generic drug user fee for all generic drug manufacturers including small manufacturers which typically face cash-crunch problems. Thus, if this legislation is passed it will have a provision for allowing waivers and refunds of user fees to small generic drug manufacturers and is likely to benefit Indian generic drug manufacturers too since the bill does not discriminate between domestic and foreign generic drug manufacturer. India with growth in ageing population and low healthcare penetration will continue to be an attractive market for global Pharma Companies: Despite an adverse regulatory environment, India will continue to remain the attractive pharma market for global pharmaceutical companies on the back of growing ageing population and low penetration of healthcare. As on 2009, approximately 15% of total population in the country was in this age group of 50 and above, and by 2016 this proportion is expected to be ~18.0%. Consequently, demand for pharmaceutical products would go up. Other factors like rising income, greater awareness of personal health and hygiene, easier access to high-quality healthcare facilities, rising penetration of health insurance and media are some of the important factors expected to drive the pharmaceutical industry in India. To access the untapped opportunity in growing domestic pharma business, multinational pharma companies are entering into strategic alliances with domestic generic manufacturers. ]]> <![CDATA[Sharda University, AIIMS to organize conference on multidisciplinary healthcare]]> https://biospectrumindia.com/news/95/3557/sharda-university-aiims-to-organize-conference-on-multidisciplinary-healthcare.html https://biospectrumindia.com/news/95/3557/sharda-university-aiims-to-organize-conference-on-multidisciplinary-healthcare.html Fri, 03 Jan 2014 15:12:00 +0530 Given the fact that healthcare has been the most pressing issue in today's modern and developing India, Sharda Hospital/ University along with AIIMS, New Delhi are jointly holding the 'International Conference on Multidisciplinary Healthcare 2014' at New Delhi. The six day brainstorming session from January 9, 2014 to January 14, 2014 at the AIIMS premises, will look into various aspects of healthcare with respect to clinical practice, research & development, evidence based practice & administration. The conference is aimed to underscore the importance of good health, which will be taken up by renowned health care professionals. The sessions will highlight the approach and significant factors involved in managing a healthy lifestyle. The workshop is intended to focus on Development of Evidence Based recommendations for Diagnosis and Treatment for Health Professionals, the recent trends and various medical, surgical and therapeutic Approaches in Cardiac and Neurological Rehabilitation along with Assessment, Diagnosis and interpretations for Multidisciplinary Healthcare Professional in current scenario. Mr P K Gupta, chancellor, Sharda University and founder chairman, Sharda Group of Institutions, said: "We are extremely hopeful that such an initiative taken under the guidance of experts from the medical field will be a crucial platform to discuss health issues along with remedial measures. It gives me immense pleasure that Sharda Hospital got this opportunity to organize such an important conference with AIIMS. The conference will give an opportunity to every healthcare professional to understand the techniques for ensuring better survival outcomes." "We, at Sharda Group always strive to make a better living for people through our students, faculties and various endeavors. Partnering for such events strengthens our mission of creating a better life for one and all," he further added. ]]> <![CDATA[Mr Rakesh Bamzai steps down as Biocon's marketing president]]> https://biospectrumindia.com/news/95/3553/mr-rakesh-bamzai-steps-down-as-biocons-marketing-president.html https://biospectrumindia.com/news/95/3553/mr-rakesh-bamzai-steps-down-as-biocons-marketing-president.html Thu, 02 Jan 2014 18:13:00 +0530 Commenting in this regard, Dr Kiran Mazumdar-Shaw, CMD, Biocon, said, "Rakesh has decided to take up a very senior and challenging leadership assignment and we wish him the best for the future. We firmly believe that he will continue to be a strong brand ambassador for the company going forward.â€? On the occasion, Mr Rakesh Bamzai added, â€œI have immensely enjoyed my time at Biocon, which has been my home for nearly two decades. I have no doubt that I will remain engaged with Biocon in the future.â€? ]]> <![CDATA[Indigenous screening device for cervical cancer]]> https://biospectrumindia.com/news/95/4740/indigenous-screening-device-for-cervical-cancer.html https://biospectrumindia.com/news/95/4740/indigenous-screening-device-for-cervical-cancer.html Mon, 30 Dec 2013 07:28:00 +0530 The union minister for health and family welfare, Mr Ghulam Nabi Azad congratulated the scientists at Indian Council for Medical Resaerch (ICMR) and Institute of Cytology and Preventive Oncology(ICPO) for designing and developing this cost-effective and affordable device for screening cervical cancer in its early stages. He stated that cervical cancer is still the number one killer cancer in several parts of rural and semi-urban India. It has been estimated that about 1 lakh 32 thousand cases of cervical cancer are diagnosed every year and 74, 000 deaths occur due to it every year. It accounted for 9% of total deaths due to cancer in 2010. He further said that many of the cases may still be going unreported in many rural areas taking the number even higher. The health minister who was present at the launch event held at New Delhi, stated that with this device it will be easy to screen and detect cervical cancer in its early stages thus making treatment more effective. He stated that the Ministry of Health and Family Welfare has launched the "National Programme on Prevention and Control of Cancer, Diabetes, CVDs, and Stroke" in 2010 in 100 selected districts taken up initially as pilot project across 21 States to address the challenges posed by the rapidly increasing burden of NCDs, particularly Cancer, Diabetes and CVDs. Azad said that presently screening for cervical cancer is available only in the regional cancer institutes and medical colleges. He added that the equipment presently being used is expensive, as a result of which not many medical colleges can afford this equipment. This device, which will be much cost effective, will be first rolled out in the district and sub-district community health centres (CMCs) and subsequently in the primary health centres (PHCs), he noted. As not all PHCs have lady doctors and nurses, staffing and training will form an important part of roll out paln, he stated. Dr. V M Katoch, DG, ICMR said that this will benefit a large number of women in the country and bring down the rates of morbidity and mortality due to cervical cancer, which is high at present as it is not detected in the early stages. Cervical cancer does not occur de-novo. It starts from certain pre-cancerous states/lesions called dysplasias and it takes about a decade for cancer to develop from pre-cancerous lesions. Detection and appropriate treatment of pre-cancerous lesions will halt their progression to invasive cancers. He further stated that the accuracy and efficacy of the device has been evaluated through tests in five regions during the past two years. He also said that this device has a white light source with variable interchangeable magnification and it can be operated on 12 Volt battery in rural and semi urban areas where electric supply is not regular. Magnivisualizer has been found to pick up 1.5 times more High grade pre-cancerous and cancerous lesions than the ordinary tungsten light. Also present at the launch function were Mrs Santosh Chowdhary, minister of state (MoS) for health, Mr A. H. Khan Chowdhury, MoS (Health), Mr K Desiraju, Secretary (Health), Lov Verma, Secretary (DAC), and senior officers of the ministry of health and family welfare and scientists. ]]> <![CDATA[Cabinet okays establishment of National Cancer Institute ]]> https://biospectrumindia.com/news/95/5217/cabinet-okays-establishment-of-national-cancer-institute-.html https://biospectrumindia.com/news/95/5217/cabinet-okays-establishment-of-national-cancer-institute-.html Fri, 27 Dec 2013 11:28:01 +0530 The union cabinet on December 26, 2013 approved the proposal for setting up of National Cancer Institute at a cost of Rs.2035 crore. NCI will be set up in the Jhajjar campus of All India Institute of Medical Sciences (AIIMS) New Delhi located in Badhsa village, Jhajjar, Haryana. The project is estimated to be completed in 45 months. This is a landmark step in the arena of cancer research in the country and shall lessen the deficit of tertiary cancer care in the Northern region. Cancer is emerging as a major public health concern in India, where every year 11 lakhs new cases are diagnosed, with a mortality rate of 5.5 lakhs per year. There has been a lag of cancer treatment facilities in India, compared to WHO standard; which requires one radiotherapy machine per million population. India at present has 0.41 machines per million population. Hence, setting up of this institute will herald a new chapter in the government initiative against cancer. NCI will operate on the lines of NCI, USA and DKFZ, Germany as a nodal center for indigenous research, promotive, preventive and curative aspects of care and human resource development. This institute is aimed to plan, conduct and coordinate research on cancers which are more specific to India; like tobacco related cancers, cancer of the uterine cervix, gall bladder cancer and liver cancers. The focus will be on understanding, analyzing the cause and genesis of the above cancers. This will further translate the knowledge gained to develop feasible strategies to improve cancer care services by improvement in detection, diagnosis, treatment and quality of life of patients. The proposed institute will broadly have clinical division, research divisions, and disease management groups (DMGs). These DMGs will go in to the details of all issues pertaining to management of various cancers, site wise, besides other facilities. NCI will have 710 beds for different facilities viz. Surgical Oncology, Radiation Oncology, Medical Oncology, Anesthesia and palliative care, Nuclear Medicine etc. It will have a Tissue Repository which is the first of its kind in India. HSCC (India) Ltd, a public sector enterprise under the administrative control of the Health & Family Welfare Ministry has been appointed as Project Consultant by AIIMS New Delhi. The Project Consultant is responsible for concept, detailed design & engineering, contracting, project management and medical equipment procurement, installations and commissioning. ]]> <![CDATA[P.D. Hinduja National Hospital awarded India's best multispecialty hospital ]]> https://biospectrumindia.com/news/95/3872/p-d-hinduja-national-hospital-awarded-indias-best-multispecialty-hospital-.html https://biospectrumindia.com/news/95/3872/p-d-hinduja-national-hospital-awarded-indias-best-multispecialty-hospital-.html Thu, 26 Dec 2013 16:14:59 +0530 India Healthcare Awards by ICICI Lombard & CNBC TV18 recognizes P.D. Hinduja National Hospital & Medical Research Centre in Mumbai as the Best Multispecialty Hospital - Megapolis for this year. The India Healthcare Awards hosted every year is an initiative to honor and award centers of excellence and quality driven healthcare delivery institutions. In year 2011, P.D. Hinduja National Hospital was selected as the best amongst a few hundred hospitals, but this time ICICI Lombard, CNBC TV18 & IMRB has selected it as the best out of 3,000 healthcare providers. P.D. Hinduja National Hospital started off as a refugee camp clinic in 1951. From its humble beginnings, today it is ranked as one of the leading multispecialty tertiary care hospital of the country. It has become a reality of the founder, Shri. P. D. Hinduja's vision to provide: "Quality Healthcare for All". He had a vision that no Indian should have to go abroad for cure and care. Mr. P.P. Hinduja, who resides in Switzerland and is Chairman Hinduja Group Europe, said that this award is all because we at our Hospital work as a Parivar - a family. Both employees and patients are members of the Hospital family, allowing all to receive personalized care. He added we - the management, all medical fraternity and staff of Hinduja Hospital would like to thank ICICI Lombard, CNBC TV18, IMRB and Jury members and everyone who have recognized the work being done at our Institute. Present at the occasion Mr Joy Chakraborty Sr. Director - Operations said, "We are thankful to the organizers and jury members for recognizing our leadership role in healthcare delivery. This award once again makes us feel proud. Our patient centric care and value added healthcare delivery will inspire us to further dedicate ourselves towards the trust, confidence and support shown by our patients and healthcare fraternity." It has pioneered in making healthcare virtual and at the doorstep by launching Care @ Home and SSS- Short Stay Service in 2007 and 2008 respectively, along with Disease Management through Information Technology (IT) and mobile application. The hospital believes that healthcare delivery needs innovative products, which should be driven by outcomes and innovative technology driven accessibility at affordable rates. The hospital follows one of its guiding principles "Work to Give" by having a rural program, which was launched on the 75th birthday of the Group's Chairman, Mr. S.P. Hinduja, under LGH- Live to Give Hope Fund. Live to Give Hope is driven by the values given by the Institutions own Florence Nightingale, Smt. Lalita Girdhar Hinduja. The rural program is today attending more than 20 villages in the rural Maharashtra. The award ceremony was felicitated by Deputy Chairman of the Planning Commission, Mr. Montek Singh Ahluwalia who presented the award to P D Hinduja Hospital, COO Mr Joy Chakraborty, and head of Laboratory and Head of Laboratory Business Development, Dr Tester Ashavaid. ]]> <![CDATA['Experiments unfortunately remain at experimental level and seldom get instutionalised']]> https://biospectrumindia.com/interviews/95/6794/experiments-unfortunately-remain-at-experimental-level-and-seldom-get-instutionalised.html https://biospectrumindia.com/interviews/95/6794/experiments-unfortunately-remain-at-experimental-level-and-seldom-get-instutionalised.html Thu, 26 Dec 2013 16:12:00 +0530 Q. What are the innovations in healthcare with respect from expertise to experimentation? Prof Gupta: Healthcare sector has witnessed innovations at all stages of the value chain beginning with Preventive health care and hygiene, curative practices through single or multiple curative therapies, medical diagnostic devices, surgical devices, post operative care, rehabilitation therapies, and community health and well being etc. Many of the experiments unfortunately remain at experimental level and seldom get institutionalized in the polity. There are far more experts we have in healthcare sector. Q. What are the challenges of inclusive healthcare? And has this implied need for rethinking every link in the healthcare chain? Prof Gupta: Inclusive health care not only deals with the issue of developing solutions for neglected diseases, but also extending available solutions to the bypassed regions and social segments at an extremely affordable level. It deals with creating Knowledge Networks which trigger and reinforce lateral learning across different levels of expertise in the sector. The need for what I call as the triangle of inclusive societal satisfaction must have extreme affordability, accessibility and availability. All the three As make the inclusion possible. But policies that create awareness about these options may not always be people oriented or people centric. Large number of good policies has foundered on the ground of actual availability despite having the elements of affordability and accessibility. The rethinking began when Arvind netralaya created global benchmarks of accuracy, affordability, accessibility and availability. Sometimes one may have to make tradeoffs between accuracy and affordability without any adverse side effects. Narayan hridalaya, L V Prasad eye care, and many other experiments have created worldwide recognition for Indian efforts in combing four and in some cases three As. But we are still far away from systems biology aspects where multi molecule multi target drug therapies will become routine and mainstream. Q. How the innovation ecosystem is going to be beneficial for patients?Prof Gupta: Patients need remedies for their problems, but they also need empowerment for taking care of their needs themselves and to the extent possible of their communities. Different actors in the healthcare value chain need attention and support and obviously a variegated ecosystem can only cater to the diversified needs already felt, many still not felt. Q. When we talk about innovation has India managed to bring in any X-factor in term of that?Prof Gupta: Well, yes and no. When we award 25 ideas out of 25000 we get from children all over the country, we obviously don't bet on too many. But we not ask people o vote on them. Those websites which have used popular vote to select surprising winners have not yet thrown any major surprise. I think organizations are better off by trying a large funnel, try many contradictory approaches, creating both competitive and collaborative approaches, use open innovation platforms which are genuinely symmetrical and reciprocal and then choose the winners I feel that innovations from students see techpedia.in/award are the most surprising and fascinating ones from formal sector. Informal Sector grassroots innovation have already made waves and attracted large multinational and national corporations to join hands. So something is happening at grassroots level but nothing much is happening at individuals from educational and formal Sector. Q. Being part of the government circle what you think government on their part should do more to bring in change and innovations in healthcare?Prof Gupta: It is well established that angel funding at large scale is missing from the private sector or high net worth individuals. But government can revive TePP kind of mechanism which succeeded in sowing many good ideas but unfortunately despite Dr. Mashelkar's success, subsequent leaders or team killed this program for reasons completely incomprehensible. We need thousand more sectoral responses may be. IIIF will not full this gap ABD that is a tragedy too. May be large corporations should use CSR funds for this purpose. Q. Do you think for bringing about change in healthcare sector, PPP can contribute more efficiently?Prof Gupta: PPP can be improved to PPPP that is people, private, public participation which can indeed make a difference to the health care sector ]]> <![CDATA[Government has to communicate more with the bioscience industry : Dr Raghavan]]> https://biospectrumindia.com/news/95/3010/government-has-to-communicate-more-with-the-bioscience-industry-dr-raghavan.html https://biospectrumindia.com/news/95/3010/government-has-to-communicate-more-with-the-bioscience-industry-dr-raghavan.html Thu, 26 Dec 2013 13:06:00 +0530 We want industry (bioscience) to hibernate and come up with unique solutions for the problems faced by the society and country. This was recently stated by the DBT secretary, Dr K Vijay Raghavan. Speaking on the occcasion of the Annual BioSpectrum Awards 2013 held at Bangalore on December 20, 2013, he mentioned that during his visit to a Noida based start up, he was happy to see how they had made it despite adverse conditions. "There are serious challenges before us in bioinformatics data handling, chemistry and animal research. But a positive approach can always make things work even in unfavorable circumtances ," said Dr Raghavan. He further talked deeply about the conflict of opinions and how everytime the scientific temperament had superceded all the criticism in longer run. "There are unreasonable regulations that exist asnd hamper the scientific activities. For resolving that, we have to build validatory mechanisms and the government has to communicate more with the industry", he said. ]]> <![CDATA[India, Germany cooperate in key biotech research areas]]> https://biospectrumindia.com/news/95/4551/india-germany-cooperate-in-key-biotech-research-areas.html https://biospectrumindia.com/news/95/4551/india-germany-cooperate-in-key-biotech-research-areas.html Tue, 24 Dec 2013 15:21:29 +0530 Within the agreement of Indo-German cooperation in science and technology (S&T) of 1974 and the special arrangement in biotechnology for the period, 2001-2006 signed on February 15, 2001, a programme of cooperation was signed between the Department of Biotechnology (DBT), Government of India and Forschungszentrum Julich BMBH (FZJ), Federal Republic of Germany, defining cooperation in biotechnology between India and Germany. The programme intends to stimulate new collaborations, e.g. the preparation of joint projects under national funding programmes. The programme facilitates bilateral cooperation in biotechnology between the scientific communities of India and Germany by way of joint research projects, bilateral workshops/seminar, and exchange visits of scientists. Nodal implementing agencies include DBT, Ministry of Science & Technology, Government of India, New Delhi and the German Aerospace Center, Project Management Agency (DLR-PT), Bonn are the nodal implementing agencies from the Indian and German sides respectively. Areas of cooperation include proposals in identified priority areas are biodiversity, treatment of sewage water, neuroimaging and diagnostics. The programme should have relevance to German and Indian national programmes and multinational programmes (e.g. EU-programmes); preparation of new projects in applied fields of mutual benefit and justification for collaboration; quality and originality of research approach; qualification of applicant and availability of infrastructure; proposals should include young scientists and expected results and outcomes. Scientists or faculty members working in regular capacity in Universities, national R&D Laboratories/ Institutes and private R&D institutes can apply under this programme. Partners from all kind of private sectors too can apply but financing is limited. ]]> <![CDATA[India should concentrate on R&D in pharma sector : Oscar Fernandes]]> https://biospectrumindia.com/news/95/3550/india-should-concentrate-on-rd-in-pharma-sector-oscar-fernandes.html https://biospectrumindia.com/news/95/3550/india-should-concentrate-on-rd-in-pharma-sector-oscar-fernandes.html Tue, 24 Dec 2013 13:45:38 +0530 Indian drugs are the most popular drugs in the whole world catering to almost 80 percent of the patients. India has a huge potential in the pharmaceutical sector but there is need to concentrate more on research and development. This was stated by Mr Oscar Fernandes, Union Minister, Govt of India and the Chief Guest on the occasion of the concluding ceremony of the three day Indian Pharmaceutical Congress at Amity University. The minister extended his full support to the resolutions passed in the conference and assured that the government would take efficient measures in empowering pharmacists in the country. IPCA passed three resolutions on the final day of the conference. The first resolution passed by IPCA recommended a strict compliance of Drugs and Cosmetic Act, 1940 and Rules 1945 and the Pharmacy Act by all the Central and state level agencies. The strict compliance to these acts will help in reducing dispensing errors. The second resolution recommended that the Pharmacy education at all levels must come under a single regulatory control and all powers should be vested with Pharmacy Council of India. It should have complete authority and accountability to improvise the educational standards at all levels. The third resolution sought an amendment in Rules 71 (1) and 76 (1) under Drugs and Cosmetics Rules 1945 according to which candidates possessing bachelors in pharmacy shall only be considered as expert technical staff in drug manufacturing and analysis. B N Singh, Managing Director, Alkem Laboratories and the Guest of Honour on the final day of the conference said that there is a need to follow a well defined strategy to empower pharmacists. "We can empower pharmacists through continuous education, aligning the system and emphasize on better interaction and communication with the pharmacists and the society", said Singh. He said that there is an urgent need for skill development and training to empower pharmacists. He said that the pharmaceutical education in India has evolved to a great extent and pharmacist associations and institutions must engage with the policy makers for the development of pharmacy education in India. Atul Kumar Nasa, President, The 65th Indian Pharmaceutical Congress Association thanked the guests, dignitaries and all the delegates for making the Congress a huge success and supporting IPCA in passing the resolution seeking further action from the government. ]]> <![CDATA[Carna medical to establish medical logistics network in India]]> https://biospectrumindia.com/news/95/3541/carna-medical-to-establish-medical-logistics-network-in-india.html https://biospectrumindia.com/news/95/3541/carna-medical-to-establish-medical-logistics-network-in-india.html Mon, 23 Dec 2013 16:09:35 +0530 The Indian company has been founded with an investment of $4million in its first phase. This pioneering venture has been created for the purpose of generation and distribution of medical and material database and to establish a logistics network. India has witnessed a dramatic growth in the healthcare sector. There has been a rise in the number of hospitals, which is equally proportionate to the huge demand of services in the medical sector. However, since each hospital has its own unique name and code for a product (syringe, needle and catheter), at the time of the inventory management and placing orders to the distributors it can lead to mistakes in orders or delivery, and shortage of stock and excess inventory. Hence, for further development, a Medical Standard Code and a fundamental database system is the need of the hour. Carna Medical Database has been created for maintaining a comprehensive medical database and an efficient logistics network in India. It is the first company in India to set up the standardized coding system for medical consumable and to launch a service medical database. The company will utilize its investors experience in providing world class services to the healthcare sector in Japan. The company has set up its operations in Gurgaon, Haryana. Speaking on the occasion of the company's launch Mr Minoru Amano, Chief Executive Officer, Carna Medical Database Pvt Ltd, said, "Carna is a protective Roman Goddess, who is believed to bring strength to the body. In that spirit, we hope to also assist the healthcare sector in India in our own way to ensure smooth and glitch free services to the patients. We are hopeful of garnering a positive response with our venture. Medical services in India are world class but still need to be streamlined. We can facilitate in the streamlining process. Medical Standard Code and fundamental database system will help organize the Indian healthcare system and ensure a smooth functioning without any hitches." Dr. Ashustosh Sukla, Managing Director, Carna Medical Database Pvt. Ltd. said, "The healthcare system in the country is developing rapidly and continues to expand in coverage, services and spending in both private and public sector. This has created a large market for hospital information and support system. At Carna we create medical material database and establish a logistics network based on this database. This database will help organize the health sector even further by making the system more efficient and less time consuming." ]]> <![CDATA[Research opportunity in Pigeon Pea ]]> https://biospectrumindia.com/news/95/3543/research-opportunity-in-pigeon-pea-.html https://biospectrumindia.com/news/95/3543/research-opportunity-in-pigeon-pea-.html Mon, 23 Dec 2013 15:22:38 +0530 The ISCB is a bilateral research and product development programme jointly funded and steered by the Indian and Swiss governments. The overall goal of ISCB is to contribute towards food security in the Indian context through innovative life sciences and biotechnology approaches, supporting sustainable and climate resilient agriculture. Innovative biotechnological products and processes addressing Indian agriculture with relevance to small and marginal farmers' needs and demands are developed and validated; their dissemination and adoption is promoted through public and private partners. The ISCB participatory circular value chain is the key implementing strategy and is consequently followed up from research to adoption of a product by the farmers. This means in particular that the research stage should be focused towards product development and directed towards needs of small and marginal farmers. ISCB has therefore invited pre-proposals on genetic improvement of the pigeon pea crop employing modern biotechnology tools and techniques along with relevant socio-economic research proposals from individual scientists of Indian and Swiss institutions to be submitted either independently or jointly (preferred with shared objectives) with other (Indian or Swiss) investigators. The targeted crop workshop organized by the ISCB management is pigeon pea (Arhar, Cajanus cajan) which is of economic and food security importance to India. The collaboration envisages partnership with Swiss laboratories with advanced biotechnologies that can be tailored to meet the needs of genetic improvement of pigeon pea. The selected pre-proposals will be requested to form a network with other selected biotechnology and socio-economic partners. The precise and focussed research themes for the application of biotechnology candidates include genetic enhancement by developing varieties of different maturity (short duration) with improved yield and resistance to Pod borer (novel and alternative approaches except the use of Cry genes) and abiotic stresses (water use efficiency). Development of hybrids through improvement of existing cytoplasm male sterility (CMS) system and employing novel biotechnologies for the purpose of speeding up the availability of quality seeds of improved varieties. ]]> <![CDATA[ Biocon collaborates to develop novel siRNA based therapeuticsÂ ]]> https://biospectrumindia.com/news/95/3548/-biocon-collaborates-to-develop-novel-sirna-based-therapeutics-.html https://biospectrumindia.com/news/95/3548/-biocon-collaborates-to-develop-novel-sirna-based-therapeutics-.html Thu, 19 Dec 2013 17:14:00 +0530 However, the financial terms of the pact were not disclosed. Through this pact, Biocon will have access to Quark's innovative and proprietary siRNA technology platform that will be leveraged for the development of novel therapeutics for various unmet medical needs. This collaboration will enable Biocon to co-develop, manufacture and commercialize QPI-1007, a novel siRNA drug candidate for ophthalmic conditions, for India and other key markets. Commenting on the occasion, Ms Kiran Mazumdar Shaw, CMD, Biocon, said, "We are very excited to partner with Quark to develop novel and promising siRNA therapeutics. Our joint development efforts on QPI-1007, targeting ocular neuroprotection aims at providing relief to several patients suffering from serious ophthalmic conditions. This collaboration reinforces our commitment to develop and introduce innovative therapeutics to India to meet the unmet medical needs." QPI-1007 is being developed for ocular neuroprotection in NAION (non- arteritic anterior ischemic optic neuropathy) and acute angle closure glaucoma. "We are very pleased to collaborate with Biocon. We believe siRNA is going to make a very important impact in the field of pharmaceuticals discovery and development. We are hopeful that this collaboration will position Biocon as the leading siRNA company in India and as an international player in this new drug category," said Dr Daniel Zurr, CEO, Quark Pharmaceuticals. RNAi technology is used in the interfering with the expression of a specific gene. ]]> <![CDATA[IIT Kharagpur crowned winners of Edison Challenge 2013]]> https://biospectrumindia.com/news/95/3535/iit-kharagpur-crowned-winners-of-edison-challenge-2013.html https://biospectrumindia.com/news/95/3535/iit-kharagpur-crowned-winners-of-edison-challenge-2013.html Fri, 13 Dec 2013 14:15:00 +0530 The winners were awarded Rs 10 Lakh, and the runners-up were presented with a cash prize of Rs 5 Lakh. The winning team, consisting of Dr Debdoot Sheet, Dr Kausik Basak, Dr Sri Phani Krishna Karri, and Dr Tamoghna Ojha, presented their innovation called, 'SinCLAIR', a mobile app for accurately diagnosing skin cancer and related abnormalities for the resource constrained patient pool and rural population. The winning team's lead, Dr Debdoot Sheet, Senior Research Fellow, School of Medical Science and Technology, IIT Kharagpur, expressed, "If feels awesome. We were a great team together. A lot of innovation and hardwork has gone into it. For the past one-and-half years, we were working on computational imaging. We weren't even sure if this would work. However, when our idea got through into the final top-five category, we realized that we can do it and we put our best foot forward." "I attribute this success to all my teachers. Like Albert Einstein, I also want to thank people who said 'no's' to our idea. Our commercial challenge would be targeting hospitals and healthcare services agencies and the regulatory woes in India, which is quite ambigous," Dr Sheet added further. Another research scholar from the 4-membered winning team, Dr Sri Phani Krishna Karri from the School of Medical Science and Technology, IIT Kharagpur, said, "I'm relaxed and quite excited as well. We've put a lot of work into this. This is going act as a seed for our dream projects in the future. The past two days were really difficult, and we even went without getting enough sleep because of all the preparations. But all that has not gone in vain." The runners-up team saw Mr Sritam Parashar Rout, Mr Himanshu Gangwar, and Mr Aditya Garg, who presented a non-invasive and portable method of detecting malignant (cancerous) tumors. The external panel of judges consisted of Mr Vijaya Kumar Ivaturi, India Innovation Labs, Prof S Mohan, IIT Madras, Mr Siraj Dhanani, founder & CEO, InnAccel. From the 200 applications that were received by GE India, the final five institutions, apart from the winners and runners-up, selected were: Knowledge Institute of Technology, Salem; SSN College of Engineering, Chennai; and Vellore Institute of Technology (VIT), Vellore. ]]> <![CDATA[Shackled in India, Bt Brinjal gets free run in Bangladesh]]> https://biospectrumindia.com/features/95/5874/shackled-in-india-bt-brinjal-gets-free-run-in-bangladesh.html https://biospectrumindia.com/features/95/5874/shackled-in-india-bt-brinjal-gets-free-run-in-bangladesh.html Fri, 13 Dec 2013 11:08:58 +0530 The top regulatory authority in Bangladesh, the National Committee on Biosafety (NCB), has given its approval in November, 2013, to the commercial cultivation of the Bt brinjal, making it the country first in South Asia to allow the entry of any edible genetically modified (GM) crop in its market. The four Bt brinjal approved varieties (Bt begun-1, 2, 3 and 4) have been developed by the Bangladesh Agricultural Research Institute (BARI), with the help of technology actually transferred by the India based Maharashtra Hybrid Seeds Company (Mahyco) way back in 2005-06, through a US Agency for International Development (USAID)-funded and Cornell University-managed 'Agricultural Biotechnology Support Project'. At the moment, the cultivation has been allowed at a limited scale with some conditions. Battle rages on in India The Indian agri-biotech industry, which of late has been disappointed by the continuous hush hush attitude on the field trials of Bt crops, is looking at the development very curiously. The majority of Indian agriculture scientific community too feels that their voice has been often ignored in the din of political voices crying hoarse. Currently the case is being heard in the Supreme Court of India where both the sides are putting up strong arguments, justifying their respective stands. The court had earlier appointed Technical Expertise Committee (TEC) which in its report had asked for ban on the GM crops till the regulatory process achieved clarity. There are contradicting views between the five independent members of the TEC and a separate report by a sixth member, Dr R S Paroda who doesn't see any issues with open trials of GM crops. He chose to later submit an independent report to the court. According to Dr Virander Chauhan, director, International Centre for Genetic Engineering and Biotechnology (ICGEB), " India must realize that after Bangladesh, the other South Asian countries such as Burma, Thailand too can follow the suit, leaving India bereft of any benefit despite the years of research. "Bangladesh took technology from India, developed biosafety guideline with our help and now has taken lead too, while we keep sitting on this important issue." Mr Ajay Vir Jakhar, chairman, Bharat Krishak Samaj who vouches for the successful cultivation of Bt cotton, is of the firm belief that Indian must not wait more on the crucial technologies. Speaking at a event recently, he said, "We Indian are always more concerned about the hue and cry raised by all sections who don't even understand science. The science must be left to those concerned and not confused with the politics." Dr N Seetharama, executive director, Association of Biotechnology Led Enterprises (ABLE-AG) emphasized that the technology dissemination is very important. "GEAC issue requires to be sorted out as soon as possible as its defunct status is a major concern for whole agri-biotech sector," he says. ABLE-AG has been at the forefront of the pro GM activities and galvanizing support for GM crop trials. At the same time, the anti-GM food groups based in Delhi have sought government's intervention under international convention and protocol to halt Bangladesh from doing so. The organizations believe that the move may endanger rich biodiversity of entire South Asia. The activists have asked the government of India that it must take adequate measures under the Article 25 of the Cartagena Protocol on Biosafety to stop any such transboundary movement of the GM crop in the eventual case of Bt Brinjal cultivation in Bangladesh. The Convention on Biological Diversity (CBD) to which both India and Bangladesh are parties to, recommends that all measures should be put in place to protect centres of origin and diversity of crops. Raising their concerns, the civil society groups and NGOs like Greenpeace and Coalition for GM Free India have said that it was the same genetically modified Brinjal which was rejected in India and Philippines. "After the failure of getting this risky Bt Brinjal released in India and Philippines, the GM industry has now turned to Bangladesh. Once the transgenic variety of this vegetable gets clearance in Dhaka, it will automatically enter India illegally through porous border", said Rajesh Krishnan, co-convenor of the Coalition for GM Free India. Dr Vandana Siva, noted environmentalist and a known critic of GMOs in agriculture feels that biodiversity in no way must get hurt. "GM technologies are like half baked product that is being unnecessarily pushed by the industry. Once at one of the meetings of biotech industry, I was told that we cannot wait for more tests because then we will loose revenues and competition. I feel that there lies the problem," she told BioSpectrum. Meanwhile, a group of scientists have signed a petition to Prime Minister of India demanding ban on all the GM crop field trials outside greenhouse. The five scientists who have drafted the letter are prominent molecular biologist and founder director of Centre for Cellular and Molecular Biology, Mr PM Bhargava; former vice chancellor, Calcutta University, Mr RN Basu; Dinesh Abrol of Institute of Studies in Industrial Development and Jawaharlal Nehru University in Delhi; Mr VS Vijayan, former chairman, Kerala State Biodiversity Board. It has been endorsed by hundreds of other scientists including eleven former and present vice chancellors of universities across the country. Will there be repeat of Bt cotton experience Many prominent agri-experts on both the sides agree that once Bangladesh allows cultivation of GM food crops on full scale, the existing moratorium on Bt Brinjal in India may not remain relevant as the transgenic variety of the vegetable, can easily seep into Indian side through porous border. Therefore, it gives rise to a possibility that the government might have to by default agree to the industry demands in the long run as in case of Bt cotton, which now is counted among the big success stories in agricultural space. This might also as well, become a good case of argument in Supreme Court, where there is an ongoing case being battled out between pro and anti GM stakeholders. Dr Deepak Pental, former vice chancellor, Delhi University is rather very straightforward in asking few hard hitting questions to those who oppose GM. "It will be downright foolish to ignore this development. We keep on typing knots and untying them will take a lot of time. So far we have not released anything in proper fashion. Even those who demand ban on all GM crops for the future, are not talking about Bt cotton. It will be unfortunate that if Bt brinjal comes in under clandestine circumstances and finally illegal cultivation without proper segregation happens, making the government to accept the facts later." Mr Tariq Anwar, minister of state for agriculture and food processing, recently at an event expressed hope that soon the technologies beneficial for the country will get acceptance from all the sections of the society. "We are unable to derive full benefits of the technologies so far. Biotech is expected to play a great role in the crop improvement. This issue needs to be debated as the issue has been contentious across globe. Technical committee requires to be constituted in a proper way. Robust system required for scientific," said the minister. Anwar further admitted that there certainly are loopholes in the governance. "Something is seriously wrong with how the system operates," he said. Evolving common ground is a must While advanced technologies can provide much of the solutions for improved production and sustainability, the debate about use of such technologies to meet our future food requirements has reached a deadlock for long. Prof. R B Singh, president, National Academy of Agricultural Sciences (NAAS) feels that though the genetically modified (GM) technologies have been a point of different perspectives and debates, there must be efforts to keep the discussion on. "Different ministries hold divergent opinions on the issue. But the Prime Minister's opinion on the issue has been clear that liberation of science is important for the human society as the hunger of a child can't wait," said Dr Singh on the GM debate. Dr Vandana Siva puts onus on scientists and feels that they must accept that there is need to have longer biosafety tests. "Rather than just harping on one fact that we are done on biosfatey for once and all, they must also take civil society's concerns into account, she says. Many like Dr Virender Chauhan believe that the ongoing debate has to end somewhere and if it doesn't very soon, then we may end up as losers. "Both the sides have to find a common ground on various aspects and adjust to each others concerns. It is important to agree on certain issues but unfortunately that hasn't happened so far." One positive thing that emerges out of the scenario, is that there is a common intent on both the sides, to ensure food security for future generations. However, the questions that still hang fire are that whether India in longer run, would be able to produce enough food without any help from genetic engineering? And would activists forever ignore technology intervention in agriculture? Hope we find some satisfactory replies in due course. ]]> <![CDATA[Supercomputing puts Indian agriculture on fast-track mode ]]> https://biospectrumindia.com/features/95/4917/supercomputing-puts-indian-agriculture-on-fast-track-mode-.html https://biospectrumindia.com/features/95/4917/supercomputing-puts-indian-agriculture-on-fast-track-mode-.html Thu, 12 Dec 2013 17:04:00 +0530 Nobel laureate and noted scientist, Dr Walter Gilbert once remarked that most of the biological investigations in 21st century will be in silico. Proving him right, the advent of genetic engineering and genomic approaches, have opened new vistas for increasing the productivity and quality attributes of bio-systems. During the last one decade, genomics has witnessed an information explosion and creation of databases, not amenable to traditional analytical approaches. Here came the role of bioinformatics that emerged as an inter-disciplinary programme, linking computational and mathematical sciences with life sciences. ASHOKA is the name of India's first supercomputing hub for Indian Agriculture has been established at Centre for Agricultural Bioinformatics (CABin), that stands for advanced super-computing hub for OMICS knowledge in agriculture. The CABin is a part of the Indian Agricultural Statistics Research Institute (IASRI), New Delhi, involved in the development of partnerships at various levels among national and international organizations in the field of bioinformatics and related fields. The main centre for CABin will have dedicated high speed connectivity to domain centres working in different domains of agriculture such as crops, animals, fisheries and agricultural microbes. Further with the active support from agriculture ministry and fruitful partnership with the CDAC, Pune, the IASRI is setting up a nationwide grid of supercomputers for agri-biotech research, agricultural planning and research. Aim is to bring the biologists, statisticians and computer scientists together from the point of view of system biology approach and effective problem solving. This computational facility will not only for researchers of the Indian Council of Agricultural Research (ICAR) but all agri- scientists across the nation. Although, activities related to bioinformatics were initiated at different ICAR institutions at small scale in isolated mode, hardly any coordinated efforts were made to integrate these activities at national level in the field of agriculture. Therefor, this supercomputing environment is being developed for high performance computing in the field of agricultural bioinformatics and computational biology under a sub-project "Establishment of National Agricultural Bioinformatics Grid (NABG) in ICAR" of the National Agricultural Innovation Project (NAIP), Indian Council of Agricultural Research (ICAR) New Delhi. The facility is set up in a state-of-art data centre and two super-computers of this hub are listed at rank 11 and 24 in the Indian Institute of Sciences (IISc) list of top super-computers of India. This super-computing hub consists with hybrid architecture of high performance computing having (i) 256 nodes Linux cluster with two masters with 3072 cores and 38 Tera Flops computing, (ii) 16 nodes windows cluster with one master, (ii) 16 nodes GPU cluster with one master with192 CPUs + 8192 GPUs and (iv) SMP based machine with 1.5 TB RAM. Also, this hub has approximately 1.5 Peta Byte storage divided in to three different types of storage architecture i.e. Network Attached Storage (NAS), Parallel File System (PFS) and Archival. This hub also consists of super-commuting systems ( 16 node Linux cluster with one master with 40 TB storage) at National Bureaux of Plant Genetic Resources (NBPGR) New Delhi, and Lucknow, National Bureaux of Agriculturally Important Microbes (NBAIM) Mau and National Bureaux of Agriculturally Important Insects (NBAII), Bangalore which forms a National Agricultural Bioinformatics Grid in the country. Number of computational biology and agricultural bioinformatics software/workflow/pipelines along with National Biological Computing Portal are in the process of development, which will provide seamless access to these biological computing resources to the biological researchers across the country. According to Dr Anil Rai, head and principal scientist, CABin, "We are trying to build this system so that scientists don't have to come here every-time for the analysis but to ensure that they can carry out the same while sitting on their desktops. For that we are building national bioinfomatics portal which is almost 80 percent ready. There is a provision for monitoring of the data results by respective scientists regualarly and even sms alerts to provide quick info on progress is also there. This system will support computational requirements of the biotechnological research in the country. This will also bridge the gap between genomic information and knowledge, utilizing statistical and computational sciences. Further, this will help in establishment of large genomic databases, data warehouse, software & tools, algorithms, genome browsers with high-end computational power to extract information and knowledge from cross-species genomic resources." Dr Dinesh Kumar, senior scientist (biotechnology), CABin believes that it is a right step forward."It will open up new vistas for downstream research in bioinformatics ranging from modelling of cellular function, genetic networks, metabolic pathways, validation of drug targets to understand gene function and culminating in the development of improved varieties and breeds for enhancing agricultural productivity to many folds," he mentioned in a visibly excited tone. Creation of a national level grid It is proposed to link all projects and activities in the field of agricultural bioinformatics in the country to the National Agricultural Bioinformatics Grid (NABG), comprising six national Institutes under the aegis of CABin. This network of institutions is based on two-tier architecture and it will be able to bridge the gap between genomic information and knowledge, utilizing statistical and computational sciences. Also, this model will help in the development of partnerships at various levels among national and international organizations. Further, this will also establish functional linkages among researchers and scientists in the field of bioinformatics and related fields. CABin will also facilitate the opening up of new vistas for downstream research in bioinformatics ranging from modelling of cellular function, genetic networks, metabolic pathways, validation of drug targets to understand gene function and culminating in the development of improved varieties and breeds for enhancing agricultural productivity. It will have high-end super computational facilities for voluminous data warehousing, processing and interpretation. Dr U C Sud, director, IASRI feels that the move will bring about new paradigms in agriculture. "The infrastructure build by ICAR over the period of time has resulted in huge transformation. We have gained enormous expertise in the area of statistics and data analytics. The creation of NABG will further help in streamlining of huge set of data that has been accumulated through research efforts of Indian scientists. I believe that the results shall be overwhelming." The second tier of this grid is five Domain Bioinformatics Centres (DBC) connected through dedicated high-speed connectivity with CABin. These centres will cater to the needs of the institutions working in different domains of agriculture such as crops, animals, fisheries, agricultural microbes and agricultural insects. The DBC's will provide services and support to institutions in their respective fields of research. The centres are also responsible for information generation and knowledge delivery from CABin to respective domain institutions for conducting experiments. The DBC's will maintain and verify data quality of genomic information from all sources in their respective domains. The domain centre of this architecture will be responsible for the collection of raw genomic data from laboratories of their respective domain and share information with CABin. The in silico findings in genomic data will be tested and validated through wet lab experiments at the respective domain institutions. The CABin is at IASRI, New Delhi. The DBC's are in NBPGR, New Delhi (Crops), NBAGR, Karnal(Animals) NBFGR, Lucknow(Fisheries) and NBAIM Mau (Agricultural Microbes) and NBAII, Bangalore (Insects). The CABin and DBC's of National Agricultural Bioinformatics Grid are connected through high speed Wide Area of Network (WAN) for seamless information flow. Initially it is proposed to connect the main centre by 64 Mbps and DBC' 32 Mbps bandwidths. Since establishment of National Agricultural Bioinformatics Grid (NABG) in ICAR needs state of art civil work, air-conditioning systems, security systems, designing of High Performance Computing Centre (HPC), procurement of advance hardware and software for supercomputing and their integration suitable for various application areas of bioinformatics. This requires intensive experience and expertise in different fields of science and technologies. Therefore, it was decided to invite International Competitive Bid (ICB) to carry out the task for implementation of this complete High Performance Computing (HPC) Systems which includes computing resources, data centre for environmental and security maintenance and monitoring high end storage systems and other related facilities. Apart from this, this system needs to be configured, tuned and optimized for undertaking biological computational research in advance area of agricultural bioinformatics by the researchers through on-line Web portal for routine jobs. In this all available applications and software needs to be configured and ported on parallel processing environment for efficient utilization of computing resources. Further, to specific project based problems tools and techniques will be developed and implemented. The technical facilitator In order to access the grid services, general scientific user communities need to deal with the underlying system which makes them to be burdened with the computational aspect rather than their research area, as most of the scientific users often lack specialized expertise to deal with the complex HPC environments. Therefore, the web based interface which shall be developed by Centre for Development of Advanced Computing (C-DAC), Pune, will be an obvious choice for the end user due to the familiarity with regular internet usage. Web browser-based portal user interfaces provide access to a large variety of resources, services, applications, and tools. Additionally, grid-enabled portals can deliver complex grid solutions to users, wherever, they have access to a web browser running on the internet without need to download or install specialized software or take care of setting up networks, firewalls, and port policies. "The CABin shall help various domain centres for taking up research and development activities in their respective areas. These institutions will also be responsible for information collection and generation of knowledge of the respective domain which in turn shall be a much valuable input to the Agricultural scientific community of the nation", mentioned Dr Pradeep K Sinha, senior director (HPC and R&D), C-DAC. Bioinformatics group of C-DAC has been working in the areas of genome annotation and comparative genomics since the last decade. The group participated in the Critical Assessment of Function Prediction (CAFA) challenge. The method proposed by C-DAC is based on similarity search and is titled 'Functional Annotation using Similarity Search' (FASS). It ranked 8th and was rated amongst the top teams across the globe. The work has been published in the March issue of the highly reputed journal Nature Methods (2013) titled 'A large-scale evaluation of computational protein function prediction'. Mr. Goldi Misra, head, HPC Solutions Group, C-DAC, "The network of institutions based on two-tier architecture in bioinformatics will bridge the gap between genomic information and knowledge, utilizing statistical and computational sciences. It will also open up new vistas for downstream research ranging from modelling of cellular function, genetic networks, metabolic pathways, validation of drug targets to understand gene function and culminating in the development of improved varieties and breeds for enhancing agricultural productivity." There is no two thoughts about the fact that the project is of a great national importance and the innovative approach shall bear fruits in near future. ]]> <![CDATA[Honeywell white paper: Pharma packaging has become highly demanding ]]> https://biospectrumindia.com/news/95/7793/honeywell-white-paper-pharma-packaging-has-become-highly-demanding-.html https://biospectrumindia.com/news/95/7793/honeywell-white-paper-pharma-packaging-has-become-highly-demanding-.html Wed, 11 Dec 2013 18:03:00 +0530 As per the whitepaper authored by Dr Thomas Dries, Honeywell's Market Development Manager Europe, Healthcare & Packaging, drugs in today's pharmaceutical environment are more demanding than ever before. The pathway to a successful launch has become more difficult as pharmaceutical companies face a variety of internal and external pressures. Beyond safety and efficacy pharma companies have to demonstrate treatment effectiveness and improved outcomes of newly launched medicines versus next best alternatives already marketed. At the same time growing external cost pressures are adding to creating a much leaner Pharma-internal environment geared to streamlining processes at the boundaries of Drug Discovery, Pharmaceutical Development and Pharmaceutical Operations. "Doing it right the first time!" and "Doing more with less!" have become the name of the game in many companies. Beyond safety and efficacy Pharma companies have to demonstrate treatment effectiveness and improved outcomes of newly launched medicines versus next best alternatives already marketed. At the same time growing external cost pressures are adding to creating a much leaner Pharma-internal environment geared to streamlining processes at the boundaries of Drug Discovery, Pharmaceutical Development and Pharmaceutical Operations. In this context, packaging solutions that address multi-stakeholder needs holistically have gained growing importance. This holds true in particular for the packaging of oral solids - still the most preferred dosage form. The high global prevalence of blister packs as observed today is based on a unique combination of value creating features such as flexibility in pack design and processing. This paper therefore, focuses on thermoformed packaging which increases the likelihood of passing stability tests and simplifies patients' lives as well as the entire pharmaceutical value chain. In conclusion, the report mentions that today's pharmaceutical manufacturers must reconcile a wide range of disparate needs to successfully launch a drug. Globalization brings with it the need for better shelf, simplified supply chains, and greater productivity. The emphasis on the drug formulation pipeline plus the physical and chemical nature of new APIs is also driving the need to optimize packaging choices holistically. At the same time, there are ongoing efforts to develop slimmer packs with smaller footprints that better matchusers' lifestyles. These trends result in more restrictive conditions that can impede the introduction of new products. To counteract these constraints, pharmaceutical companies are turning to ultra-high barrier thermoform films, such as Honeywell Aclar ® Films, that address multiple stakeholderneeds. A thermoform platform increases the likelihood of passing stability tests and simplifies patients' lives as well as the entire pharmaceutical value chain. ]]> <![CDATA[Lilly launches Lil Therapeutics, Enters branded generics market ]]> https://biospectrumindia.com/news/95/1501/lilly-launches-lil-therapeutics-enters-branded-generics-market-.html https://biospectrumindia.com/news/95/1501/lilly-launches-lil-therapeutics-enters-branded-generics-market-.html Wed, 11 Dec 2013 17:39:00 +0530 Eli Lilly and Company India on December 10, announced entry in the branded generics segment with launch of Lil Therapeutics, an expansion of its oncology division that will help expand delivery of cancer drugs to patients at an affordable cost. India is the first country to witness the launch of branded generics from the house of Lilly. Today, Lilly launched four new drugs, Lilbecep (Epirubicin), Lilmantro (Anastrozole) and Lilxapla (Oxaliplatin) and Lilrincan (Irinotecan) for the treatment of patients with Breast cancer and Colo-rectal cancer respectively. These molecules are well established and time tested across the treatment algorithm of Oncology. Lilly has been dedicated to delivering solutions that accelerate the pace and progress of cancer care and enhance the lives of people living with cancer. In India, Lilly has cultivated a strong equity in the Lung Cancer segment with innovative brands Gemcite and Alimta. With launch of Lil Therapeutics, Lilly aims to expand patients' access to high-quality cancer drugs. Commenting on the development, Mr. Edgard A Olaizola, Managing Director, Eli Lilly mentioned, "Lilly is committed to improving outcomes for individual patients around the world. We understand that Cancer medicines of the highest quality continue to be an unmet need in India and as a responsible organization, we have been working over the years to make cancer drugs affordable to better serve Indian patients. This launch reaffirms our commitment to reach more patients and play a leading role in fighting cancer in this country". He also mentioned, "Though Lilly is launching branded generics in the oncology segment, we will continue to discover and develop innovative new therapies for patients worldwide." ]]> <![CDATA[Nova ropes in VP Kamath as COO]]> https://biospectrumindia.com/news/95/7235/nova-ropes-in-vp-kamath-as-coo.html https://biospectrumindia.com/news/95/7235/nova-ropes-in-vp-kamath-as-coo.html Wed, 11 Dec 2013 17:27:53 +0530 Nova Medical Centers, India's leading chain of short-stay surgical centers and fertility clinics, announced the appointment of V P Kamath as the Group Chief Operating Officer (COO). Based out of Bangalore, Mr Kamath will be responsible for the general management of Nova's Surgical Hospitals, Infertility Clinics, IVIOMICS Genetic Testing Lab and ART Bank businesses spread across 20 locations. Announcing the appointment, Mr Suresh Soni, Chairman & CEO, Nova Medical Centers, said, "Mr. Kamath is a well-respected veteran of the healthcare industry, with over 25 years of experience in leadership, general management, operations, sales and marketing and business development with some of the top players in the field. His vast experience, leadership skills and industry insights make him a very strong addition to Nova's management team." During his career, Mr Kamath has been associated with healthcare majors such as Wockhardt Hospitals, Apollo Hospitals, Nicholas Piramal, and Johnson & Johnson. He holds a Master's degree in Microbiology and an MBA degree, both from the University of Mumbai. He has also attended the Advanced Management Program at the Walter A. Haas School of Business, Berkeley, California. Commenting on his new role, Mr Kamath said: "The Indian healthcare industry is at an inflection point in terms of opportunities and growth potential. Nova Medical Centers is at the forefront of this change and has already carved a niche in the surgery and fertility space. It is not only very exciting to get associated with such a dynamic company, this opportunity also allows me to get closely connected with the society at large and make a difference to people's lives. Joining Nova comes with a great responsibility to further build on the tradition of excellence that the brand represents, making it the most advanced and admired healthcare institution." Mr Kamath is also a visiting faculty member at IIM Ranchi, MET and NMITD, Mumbai, and is on the steering committee of Goa Institute of Management. For his outstanding and extraordinary achievements in Healthcare and Education, Mr. Kamath was recently awarded the "Bharat Excellence Award" and the "Rashtrya Jewel Award". ]]> <![CDATA[Policy makers to discuss innovative solutions to global health challenges ]]> https://biospectrumindia.com/news/95/6167/policy-makers-to-discuss-innovative-solutions-to-global-health-challenges-.html https://biospectrumindia.com/news/95/6167/policy-makers-to-discuss-innovative-solutions-to-global-health-challenges-.html Wed, 11 Dec 2013 16:48:01 +0530 World leaders and policy makers gathered in Doha to discuss innovative solutions to the most pressing global health challenges at the inaugural World Innovation Summit for Health (WISH). Under the patronage of Her Highness Sheikha Mozabint Nasser, chairperson of Qatar foundation for education, science and community development, WISH brought together close to 1000 global health innovators and policy makers including heads of state, ministers, senior government officials, academics and influential business leaders from 67 countries. There will also be a special panel on health and ethics.Innovations will be on display in state of the art innovation 'pods' alongside the individuals who turned these novel ideas into practical solutions. Delegates at the Summit will hear from distinguished keynote speakers including Simon Stevens, president of Global Health Division, United Health Group; Daw Aung San Suu Kyi, chairperson of Myanmar's National League for Democracy; Boris Johnson, Mayor of London; and John Dineen, president and CEO of GE Healthcare. The Mayor of London, Boris Johnson said, "There are many health issues that are of global significance, but every country around the world also faces its own set of challenges. Bringing together key international leaders is a great opportunity to exchange ideas and learn from excellent and innovative work elsewhere." The Right Honorable Professor the Lord Darzi of Denham, executive chair of WISH, said, "Healthcare is facing some of its greatest ever challenges and if we are to succeed in tackling them, all nations must find new and innovative ways to treat and prevent illness. We want to inspire people to take up the best ideas and implement them in countries all over the world, closing the gap between what we know and what we do. And by bringing together people with the power to make a real difference, our ambition is to help improve the health of people everywhere." The second day of the Summit will include the launch of the global innovation diffusion report, a ground-breaking initiative that investigates and compares how eight countries' healthcare systems foster, implement and share medical innovation. The innovative research looks at how Qatar, India, Brazil, the UK, US, Australia, Spain and South Africa diffuse the best new ideas to improve healthcare for their populations. Engineer Saad Al Muhannadi, president of Qatar foundation said, "Qatar foundation embodies Qatar's National Vision 2030 and supports initiatives that create a healthy and strong society. Fostering healthcare innovation in Qatar and abroad is an integral part of our drive at Qatar foundation and it gives me great pleasure to welcome our distinguished guests from diverse corners to WISH and Qatar." WISH supports the aims and ambitions of Qatar foundation and reinforces Qatar's role as an emerging center for medical innovation. Qatar has been at the forefront of healthcare reform in the region with its introduction of a visionary national health strategy. As part of its mission, Qatar foundation has launched a number of initiatives in healthcare - from scientific research in medicine to maternal health and clinical care. ]]> <![CDATA[Hairline International signs MoU with Merisis Therapeutics ]]> https://biospectrumindia.com/news/95/3670/hairline-international-signs-mou-with-merisis-therapeutics-.html https://biospectrumindia.com/news/95/3670/hairline-international-signs-mou-with-merisis-therapeutics-.html Tue, 10 Dec 2013 17:54:02 +0530 Hairline International Research and Treatment Center brings state-of-the-art international procedures, machinery and treatment packages to deal with hair, skin and beauty issues across the spectrum for men and women. Hairline has medical as well as beauty professionals for carrying out all procedures. To facilitate genetic testing for their patients, Hairline International Research and Treatment Center has now tied up with Merisis Therapeutics, a division of DiponEd Bio Intelligence LLP. Announcing this, Dr Dinesh G Gowda, dermato surgeon, Hairline International Research and Treatment Center said, "Anyone with hair and skin condition will now be able to get a medical forecast that will tell them with 80% accuracy their risk of going bald or developing particular skin ailments. This is a big breakthrough in the medical world as we doctors can now prescribe the right course of action to arrest progression of a disease." Dr Kaushik Deb, a senior scientist in cell and molecular biology and director, Merisis Therapeutics who has worked on genetic testing not only in India but in other countries as well says, "The analysis is literally of all the genes in the body and how they interact with each other and the environment. This profile shows gene patterns and therefore points out to any indications of the onset of an ailment. It is very popular in western countries due to its accuracy of prediction. We have brought it to Bangalore for the first time and it is sure to be a game changer in preventive healthcare space." The international human genome project worked on sequencing human DNA to create a fairly accurate way of providing medical prediction on the possibility of a person contracting a particular disease or ailment in the future. This very same concept is now being applied to hair and skin to predict the possibility of balding, onset of psoriasis and other such hair and skin diseases. Once the results of the tests are in, medical professionals will be able to provide intensive help that will prevent the onset of any ailment. Genomic profile is not age specific and can be done right from the age of 1. Mr Bani Anand, managing director and founder, Hairline International Research and Treatment Center said, "Lifestyles today are hectic, and youngsters in the 25-30 years age group are showing symptoms of balding due to genetic predisposition as well as lifestyle. With such genomic profiling, we are able to ascertain accurately whether a person is prone to excessive loss of hair. This will facilitate us in creating a customized treatment plan that ensures the health of hair and stops progression of balding." ]]> <![CDATA[Camson Agri-Ventures nominated for the SIAL Middle-east Innovation Award]]> https://biospectrumindia.com/news/95/8017/camson-agri-ventures-nominated-for-the-sial-middle-east-innovation-award.html https://biospectrumindia.com/news/95/8017/camson-agri-ventures-nominated-for-the-sial-middle-east-innovation-award.html Tue, 10 Dec 2013 17:13:18 +0530 The food industry has long acknowledged that change is the only way forward to suit the changing tastes of the consumers in the times to come. Camson Agri-Ventures (CAV) is poised to challenge the age-old conventions and is continuously working on introducing products that have unique attributes at the offering for the consumers, be it on health aspects, taste, appearance and convenience. Leading international suppliers showcased their products during the SIAL Middle East, Abu Dhabi from November, 2013, which also put a spotlight on 70 of the world's most innovative food & beverage products. Thirty one products were shortlisted at the SIAL Innovation Observatory which included Camson's Button Capsicum-Palar & Black Chilly-Kali. These products were mainly selected against specific food attributes along with the level of innovation involved in developing the product. CAV was the only Indian company to win accolades for its products at SIAL. Mr Rohit Sareen, head, Camson Agri-Ventures said "Through its farm management and farmer connect advisory model, CAV soon proposes to launch these innovative products for the consumers in India as well as for the international markets. These products have been developed using Camson Bio Technologies proprietary technology platform." Camson's hybrid "Kali" - grown using Zero Residue Cultivation TM Practices, is disease tolerant & high yielding variety thereby making it commercially viable. The black chilly's outer coating is due to the presence of rare plant carotenoid called anthocyanin, a bioflavonoid. Clinical research indicates that Anthocyanin is a highly beneficial phytochemical that has free radical scavenging properties. It also regulates hormonal functioning; boosting Cytokine production (immune function), cell membrane strengthening, anti-inflammatory activities and anti-aging properties. Anthocyanin exhibits anti-inflammatory & anti-aging properties. The Capsaicin in the chilly attributes to its pungency, which can be adjusted from 15,000 SHU (mild) to 1,00,000 SHU (high) where SHU- Scoville Heat Units. Capsaicin a natural fat burner also exhibits cancer fighting abilities as it negatively affects the protein complex NF-KAPP Beta in cancer cells thus destroying them. It also helps increase metabolism by burning fats. Research indicates that the product is loaded with natural Phytochemicals that exhibit anti-cancerous, anti-inflammatory & immune boosting properties. Its Fibrous properties also help aid the digestive system. Its relative small size compared to the traditional Capsicum helps reduce its wastage during the course of its preparation & consumption. Natural phytochemicals present exhibit various health benefits including immune boosting, anti-inflammatory & anti cancerous properties. ]]> <![CDATA[Alzheimer's disease drug market is declining and it is expected to fall till 2016 ]]> https://biospectrumindia.com/news/95/8345/alzheimers-disease-drug-market-is-declining-and-it-is-expected-to-fall-till-2016-.html https://biospectrumindia.com/news/95/8345/alzheimers-disease-drug-market-is-declining-and-it-is-expected-to-fall-till-2016-.html Tue, 10 Dec 2013 17:02:37 +0530 Bharat Book Bureau presents Alzheimer's pipeline drugs review, Alzheimer's disease drug market & forecast - global analysis. This report Alzheimer's disease drug market is on the curvature stage. Since 2003, there is not any single "magic bullet" launched in the market to prevent or cure it. However, all current marketed products are going to be generic in the next 3-4 years. There are high unmet medical needs. The current unmet needs represent a huge opportunity for pharmaceutical companies which are developing targeted novel therapies. If successful, they will be in a position to command premium prices and tap the existing opportunity. Lot of drugs has failed in Phase III stage thus putting a greater impact on Alzheimer's disease drug market. "Alzheimer's Pipeline Drugs Review, Alzheimer's Disease Drug Market & Forecast - Global Analysis" provides a comprehensive assessment of the fast-evolving, high-growth Global Alzheimer's Disease Market. This 110 page report with 29 Figures and 11 Tables studies the Global Alzheimer's Disease Drug Market. From the year 2009 Alzheimer's disease drug market is declining and it is expected to fall till 2016. But with the expected launch of some Alzheimer's drugs from the year 2017 onwards, Alzheimer's disease drug market is expected to revive in the coming years. However due to absence of exact potential drugs there will always remain a huge unmet Alzheimer's Drug Market. For the year 2018 Alzheimer's disease Drug Market will be just 10% of unmet Alzheimer's Disease Drug Market. ]]> <![CDATA[Venus Remedies signs MoU for Elores with South African pharmaceutical firm]]> https://biospectrumindia.com/news/95/6776/venus-remedies-signs-mou-for-elores-with-south-african-pharmaceutical-firm.html https://biospectrumindia.com/news/95/6776/venus-remedies-signs-mou-for-elores-with-south-african-pharmaceutical-firm.html Tue, 10 Dec 2013 15:57:45 +0530 Venus Remedies, a research-based global pharmaceutical company, has signed a memorandum of understanding (MoU) with South African pharmaceutical firm Austell Laboratories to exclusively out license its flagship product, Elores, in South Africa. A novel antibiotic adjuvant entity that effectively counters serious hospital-acquired infections caused by multidrug-resistant extended-spectrum beta-lactamase (ESBL) and metallo-beta-lactamase (MBL)-producing gram negative bacteria, Elores is likely to be launched in South Africa by mid-2015, said Venus Remedies, chairman and managing director, Mr Pawan Chaudhary. Globally, the systemic antibacterial market, which is growing at a CAGR of 7.2%, is set to reach $44 billion by 2016. The infections caused by multidrug-resistant ESBL/MBL-producing gram negative bacteria which Elores is capable of fighting comprise 25% of this market, thus creating a tremendous opportunity for Venus Remedies. The MoU between Venus Remedies and Austell Laboratories was signed recently at the Patna Technology Expo, where the top 20 innovators under the "DST-Lockheed Martin India Innovation Growth Program 2013", including Venus Remedies, were awarded cash prizes. The overall systemic antibacterial market of South Africa is worth US $275 million and growing at a compound annual growth rate (CAGR) of 10.5%. Elores will cater to the needs of about 40% segment of this market. "Venus Remedies is projected to generate a cumulative revenue of US $20 million within five years of the launch of Elores in South Africa," said Mr Chaudhary. The Patna Technology Expo was organized by the Federation of Indian Chambers of Commerce and Industry (FICCI) in association with the Department of Science and Technology (Government of India), Lockheed Martin Corporation, Indo-US Science and Technology Forum, Stanford Graduate School of Business and the IC2 Institute, University of Texas, Austin. The event offered a unique platform to the top innovators to showcase their innovations and sign global marketing deals. Dr (Mrs) Manu Chaudhary, director, Venus Medicine Research Center, who received the cash prize for Elores as the "Number 1 Innovation of 2013", said, "We are delighted to be a part of this unique endeavor that not only identifies and appreciates the innovative technologies with commercial potential but also supports the innovators of these technologies by providing them entrepreneurship training and business development assistance for successful commercialization in the global marketplace." Elores has a unique profile of action, which gives it an edge over all the existing therapies. It has resulted in more than 30% reduction in treatment time and about 50% reduction in the cost of treatment. Elores has been receiving a tremendous response from the medical fraternity across the country since its launch in India in January this year. ]]> <![CDATA[Ms Kanchan Naikawadi bagged Silver Stevie]]> https://biospectrumindia.com/news/95/3530/ms-kanchan-naikawadi-bagged-silver-stevie.html https://biospectrumindia.com/news/95/3530/ms-kanchan-naikawadi-bagged-silver-stevie.html Mon, 09 Dec 2013 17:33:54 +0530 Ms Kanchan Naikawadi, director, Indus Health Plus recently bagged Silver Stevie for two categories - Female Entrepreneur of the year in Asia, Australia and New Zealand and Female Entrepreneur of the year - consumer product at Stevie Women in Business Awards 2013 recently conducted in New York. The Stevie Awards for Women in Business honor women executives, entrepreneurs, employees and the companies they run - worldwide. The Stevie Awards have been hailed as the world's premier business awards. More than 1,200 entries were submitted this year for consideration in more than 90 categories, including Executive of the Year, Entrepreneur of the Year, Women helping Women, and Communications Campaign. It's an honor that Ms Naikawadi won Silver Award in two categories. Ms Kanchan Naikawadi, director Indus Health Plus said, "I'm glad and extremely happy that received these prestigious awards. A recognition as this would surely take us further ahead and we would continue serving the society with innovative health solutions in our category. We aim to provide quality healthcare at affordable prices to the masses through preventive healthcare checkups. We pride ourselves in facilitating, screening, generating reports and providing doctor's consultation in a single day. An innovative initiative as this to generate awareness of practicing prevention for one's health has given us a clear visibility in many regions." "For 10 years we have been recognizing the achievements of women in business, and this year's nominations were the most impressive class the judges have ever reviewed," said Michael Gallagher, founder and president of the Stevie Awards. ]]> <![CDATA[Venus bags UBM India Pharma Award for Elores]]> https://biospectrumindia.com/news/95/7303/venus-bags-ubm-india-pharma-award-for-elores.html https://biospectrumindia.com/news/95/7303/venus-bags-ubm-india-pharma-award-for-elores.html Mon, 09 Dec 2013 17:26:47 +0530 Venus remedies Limited, a leading research-based global pharmaceutical company, bagged the coveted UBM India Pharma Award for its flagship product, Elores, in the excellence in product development category at a glittering ceremony in Mumbai. UBM is a leading service provider for all global events-led marketing and communications business. It is a subsidiary of UBM PLC, a leading global business Media Company listed on the London Stock Exchange. The awards ceremony recognized select, path-breaking initiatives undertaken by the pharmaceutical industry in key areas of quality, product design, cost management, packaging, corporate social responsibility and research and development. Among the jury members for the awards were Dr Ajit dangi, president and CEO Danssen Consulting, Davinder Pal, president, Catalyst Pharma Consult, and Kaushi Desai, Director (India region), Drug Information Association. Asserting that this prestigious awards is a recognition of Venus Remedies' competitive edge in research-based products and its innovative approach, Dr Manu Chaudhary, director, research, Venus medicine Research Center, said, "It is a matter of great pride for the entire VMR team to have received this award for Elores. This is the second award for Elores in the first year of its launch. Launched in January this year, Elores is a novel antibiotic adjutant entity that effectively counters serious hospital-acquired infections caused by multidrug-resistant extended-spectrum beta-lactamase (ESBL) and metallo-beta-lactamase (MBL) - producing gram negative bacteria. Globally, the systemic antibacterial market, which is growing at a compound annual growth rate of 7.2%, is set to reach $44 billion by 2016. Elores is capable of fighting multidrug-resistant ESBL/MBL - producing gram negative infections, which comprise 25% of this market, thus creating an opportunity of more than $11 billion in the coming five-six years. Elores has received patents for the product and its method of treatment from 46 countries, including USA, India, Australia, Japan, South Korea and constituents of the European Union. While other antibiotic fails to respond to such ICU infections, Elores is effective against carbapenem-resistant bacterial strains such as E.coli, K. pneumonia, P. aeruginosa and A. Baumanni. The product has unique profile of action, which gives it an edge over all the existing therapies. It has resulted in more than 30% reduction in treatment time and cost. Elores prevents both the growth and spread of drug-resistant genes from one bacterial species to another, thus making it one of the safest and most effective drugs available to cater to multidrug-resistant carbapenem-resistant enterobacteriaceae. Elores, which has received a tremendous response from the medicalfraternity, was recently recognized as the best innovation of 2013 by a team of experts from Stanford Business School, US, IC2 University of Texas, Austin, US and Lockheed Martin Foundation in collaboration with the union department of science and technology under the Indo-US joint science and technology innovation program, 2013. The team has also selected Elores among the top eight technologies that are to be commercialized in the USA soon. ]]> <![CDATA[Escaping pilot-itis of mHealth innovations]]> https://biospectrumindia.com/news/95/7231/escaping-pilot-itis-of-mhealth-innovations.html https://biospectrumindia.com/news/95/7231/escaping-pilot-itis-of-mhealth-innovations.html Mon, 09 Dec 2013 17:19:23 +0530 BBC Media Action,(BBC's international development charity) release a policy briefing on mobile health (mHealth) 'Health on move: Can mobile phones save lives'. It was launched in New Delhi by Mr NK Singh, MP Rajya Sabha and Mr Girindre Beeharry, country head, Bill and Melinda Gates Foundation, India. The policy briefing focuses on how one of the greatest engines of innovation in the 21st century mobile phone offers important opportunities for saving lives. Commenting on the significance of the document, Mr Yvonne MacPherson, executive director, BBC Media Action, USA said, "The policy briefing 'Health on the move: Can mobile phones save lives?' shares the learning of our large scale mHealth solutions in India and is intended for those who are either using or considering using mobiles to achieve bold health outcomes. With its emphasis on designing for scale and sustainability, we hope that policy makers, governments, donor organizations, NGO's, telecom companies and technologies will find it a useful compliment to this nascent yet rapidly developing field." Although there is a proliferation of mobile health (mHealth) projects in the developing world, most succumb to 'Pilot-itis' - the inability to scale. the policy briefing reveals that in order to sustainably scale mHealth innovations it is crucial to place the 'user' at the center of the design process, adopt appropriate technology, and forge strategic and mutually beneficial public-private partnerships based on a sound business model."The ability to move beyond 'pilot-itis' relies on the use of appropriate partners and appropriate business models which are based on ground realities. It is a balancing act between using existing technologies that can save lives today versus waiting for super technologies that will become ubiquitous in the future," said Siddhartha Swarup, director, Family health programs, BBC Media Action, India. The policy briefing draws on BBC Media Action's direct experience in Bihar, a state where 83% of women have access to mobile phones, but only 9% have ever sent an SMS. Recognizing limitations faced by mobile phone users in Bihar, such as low literacy rates, BBC Media Action has used Interactive Voice Response (IVR) to make audio content accessible from any mobile phone via a simple voice call. BBC Media Action developed mHealth services 'Mobile Academy' and 'Mobile Kunji' to equip and train community health workers to communicate life-saving maternal and child health information, and 'Kilkari' to provide families with weekly audio health information linked yo a woman's stage of pregnancy or child's age. Sara Chamberlain, head of ICT, BBC Media Action says, "Public private partnerships are essential to scale, affordability and sustainability. We are able to make life-saving health content available to the majority of mobile phone subscribers in Bihar - thanks to a significant subsidy from the mobile industry, Airtel, BSNL, Idea, TATA, Reliance and Vodafone have reduced the standard commercial IVR tariff by 90%. The operators are willing to make this subsidy because they're still covering their network costs - and they recognize the value in forging meaningful, long-term relationships with rural subscribers."Taking a cue from the success of the program in Bihar, the state governments of Odisha and Uttar Pradesh are collaborating with BBC Media Action to launch the mHealth services in their respective states. ]]> <![CDATA[India's first minimal access transplant for lung performed successfully ]]> https://biospectrumindia.com/news/95/3533/indias-first-minimal-access-transplant-for-lung-performed-successfully-.html https://biospectrumindia.com/news/95/3533/indias-first-minimal-access-transplant-for-lung-performed-successfully-.html Mon, 09 Dec 2013 16:32:00 +0530 On November 24, a suitable donor became available at Christian Medical College (CMC) Vellore. Mr. Raja was offered a lung transplantation, which would give him a near normal life without oxygen. This was a minimally invasive lung transplantation. The surgical team was headed by Dr Jnanesh Thacker - Senior Consultant Cardiovascular and Thoracic Surgeon, Specialist in Heart and Lung Transplantation for Global Hospitals Group, and his team consisted of Dr Nandkishore Kapadia, Dr Vijil Rahulan, Dr Govini Balasubramani, Dr Manohar, Dr Kalyan, Dr Rajgopal and Dr Sanjay Singh. Elated over the success of the country's first minimal access transplant procedure for lung, for the team at Global Health City, Chennai, it's what they are committed to do every day, deliver their best to save lives, demonstrating exceptional clinical capabilities, innovation and deploy most advanced treatment, technology and utmost patient care. "Raja Babu Shah is the recipient of India's first recipient of Minimal Access Lung Transplant. He is also the oldest patient in India to receive a Lung Transplantation and his recuperation is going to be reduced with less pain due to Minimal Access method adopted," said Dr Vijil Rahulan, Head of Department of Respiratory Medicine & Senior Consultant Pulmonologist, Global Health City. Dr Jnanesh Thacker iterated, "Based on clinical evaluations and considering the age of the patient, we knew this transplant surgery is going to be a litmus test. We got together as a team to discuss what we need to ensure for best clinical outcomes and after that the decision was made to take the road less traveled - Minimal access mode. We did a Minimal access anterio-axillary thoracotomy with an incision, 7 inches long, just below the nipple. We ensured that the internal mammary artery is preserved." Global Hospitals Group is one of the fast growing chains of multi superspecialty tertiary care hospitals in India offering healthcare services of international standards. The Group currently has state-of the art and world class hospitals at Hyderabad, Chennai, Bangalore and Mumbai offering advanced patient care. With the most comprehensive multi-organ transplant services in the country, the Group has carved out a niche for itself by excelling in areas ranging from simple procedures to complex surgeries and multi-organ transplantation services for liver, kidneys, heart and lungs. Speaking on this occasion, Dr Ravindranath - chairman & managing director, Global Hospitals Group applauded the Transplantation Team's effort in saving the life of this patient with a novel attempt helping faster recovery. He stated, "I was pleased to know that the patient was off the ventilator on the next day and he walked inside his room on the third post operative day." ]]> <![CDATA[Thompson honors India's most innovative organizations]]> https://biospectrumindia.com/news/95/1113/thompson-honors-indias-most-innovative-organizations.html https://biospectrumindia.com/news/95/1113/thompson-honors-indias-most-innovative-organizations.html Fri, 06 Dec 2013 11:30:00 +0530 Thomson Reuters, the world's leading source of information for businesses and professionals, on December 05, 2013 acknowledged India's top innovators at the Thomson Reuters India Innovation Awards 2013. First established in 2007, the Awards recognize the most innovative academic institutions and commercial enterprises headquartered in India for their spirit of innovation in Research & Development (R&D). Among the organizations that were awarded at the ceremony were Reliance Industries Limited under 'Hi-Tech Corporate' category; Council of Scientific & Industrial Research (CSIR) in Hi-Tech Academic & Government' category and Glenmark Pharmaceuticals under 'Pharma Corporate corporate category. The National Institute of Immunology (NII) too received the award under 'Pharma Academic & Government' category. This year's guest of honor at the event was Dr. T. Ramasami, secretary to the government of India, Department of Science & Technology. The ceremony was attended by more than 150 guests comprising researchers, scientists and heads of pharmaceutical and technology companies, academics, intellectual property (IP) analysts and searchers, and patent examiners. Commenting on the Awards 2013, Swarup Choudhury, managing director, Thomson Reuters, India said, "In an increasingly globalized world, innovation is critical for enhancing competitive advantage. We at Thomson Reuters, award companies and academic institutions basis our research and analysis of their work as recorded in Thomson Reuters patent information services." "Our Intellectual Property & Science (IP&S) business drives the innovation lifecycle around the world, enabling the discovery, development and delivery of the world's greatest innovations. Since 2007, we have been presenting the Thomson Reuters India Innovation Awards to recognize innovation and entrepreneurship in India," said Vinay Singh, director, India, Thomson Reuters Intellectual Property & Science. Singh added, "India Innovation Awards celebrate excellence for continuous innovation and value add in their respective field of expertise and it is an honor to congratulate this year's winners." Commenting on their recognition in the Hi-Tech Academic & Government category, Professor Samir K Brahmachari, Director General, Council of Scientific & Industrial Research said, "CSIR today is globally benchmarked and is recognized as a successful model of post independence India's innovation system that provides globally competitive, affordable technological solutions to diverse sectors, from leather to generic drugs, pesticides to tractors, glass and ceramics to industrial catalysts, and from minerals and metals to advance materials." "Today New CSIR is full of promise for New India" and marching ahead from generic to genomic medicine and leading the world in open innovation to protection of traditional knowledge with a focus on S&T intervention for the people at the base of the economic pyramid of India," added Professor Brahmachari. Winner of the Pharma Academic & Government category, Dr Chandrima Shaha, director, National Institute of Immunology, added, We would like to make a difference to the nation by developing innovative technologies in the laboratory through discoveries spawned by basic scientific inquiry and developing them for use by the society. Our aspirations are to solve daunting problems in health emerging in modern times." ]]> <![CDATA[Karnataka awaits to embrace nano future: A 100-Cr Nano Park soon to emerge in Bangalore]]> https://biospectrumindia.com/news/95/5158/karnataka-awaits-to-embrace-nano-future-a-100-cr-nano-park-soon-to-emerge-in-bangalore.html https://biospectrumindia.com/news/95/5158/karnataka-awaits-to-embrace-nano-future-a-100-cr-nano-park-soon-to-emerge-in-bangalore.html Fri, 06 Dec 2013 00:21:00 +0530 The two-day 6th Bangalore INDIA NANO conference kick-started on December 05, 2013, in Bangalore at Hotel Lalit Ashok, organized by the department of IT, BT and S&T, Government of Karnataka. The Indian Institute of Nano Science and Technology (IINSc) will be constructed at Tumkur Road, Bangalore, funded by the Government of India. The event was graced by Hon'ble Chief Minister of Karnataka, Shri Siddaramaiah, Bharat Ratna Prof C N R Rao, FRS, National Research Professor and Chairman, Science Advisory Council to the Prime Minister of India, Nobel Laureate Prof Sir Andre Geim, FRS Kt, Regius and Royal Society Research Professor, School of Physics & Astronomy, University of Manchester, UK, Shri Srivatsa Krishna, IAS, Secretary to Government, Department of Information Technology, Biotechnology and Science & Technology, Planning and Statistics and Infrastructure Development, Government of Karnataka, Prof A K Sood, Department of Physics, Indian Institute of Science (IISc), and Shri Jagdish Patankar, MD, MM Activ Sci-Tech Communicaitons Pvt Ltd. Mr Siddaramaiah in his address also said, "Nanotechnology has the ability to converge with other technologies to address challenges in energy and environment and many more like food security, energy security, waste management and health. The ultimate purpose of science and research is to address challenges faced by comman man. I'm confident that we'll focus on practical solutions." The conference was made possible under the guidance of Vision Group on Nanotechnology led by Bharat Ratna Prof C N R Rao. Talking about India's up coming premier nanotechnology institute in the out-skirts of Bangalore, Prof C N R Rao expressed, "It'll be a center of excellence for nanoscience research and development. I'd like to invite scientists, entrepreneurs and researchers to come and do nanotechnology ventures in the state." In his speech, Dr Srivatsa Krishna, said, "The next big thing is actually very small. The global nanotechnology market will increase from $11.7 Billion (2009) to an estimated $1.1 Trillion (2015), with a CAGR of 14.8%." In 2011, China spent the highest in the area of nanotechnology research amounting to $2.3 Billion, followed by the United States at $2.2 Billion. "Today, the nano market is valued at $140 Billion, however, there is a gap between innovation and mass-market application," Dr Srivatsa added."Karnataka awaits to embrace its nano future," concluded Dr Srivatsa. Prof C N R Rao said, "Karnataka is known as the IT city. But first of all it is the city of science. I hope Mr Siddaramaiah will promote science and future technology in Bangalore city. We started a national Nano Mission about 10 years ago along with PM Manmohan Singh, to sow seeds of research in all parts of India, and provide facilities to all bright young and senior scientists. India ranks #3 in the world in the area of nano sciences." "We've many possible applications in nanotechnology. One of them is in the area of medicine, especially fabricating skin and targeting drugs for cancerous cells. It will have serious implications in medicine and health. Nanotechnology offers major challenges and great opportunities for innovation and discovery of new things. I've complete confidence in this technology," added Dr Rao. ]]> <![CDATA[Sanofi announces new phase 3 results for investigational new insulin U300]]> https://biospectrumindia.com/news/95/3525/sanofi-announces-new-phase-3-results-for-investigational-new-insulin-u300.html https://biospectrumindia.com/news/95/3525/sanofi-announces-new-phase-3-results-for-investigational-new-insulin-u300.html Thu, 05 Dec 2013 12:41:24 +0530 Sanofi on December 04, 2013, announced the full results from the EDITION II study showing that investigational new insulin U300 demonstrated similar blood sugar control with 23% fewer patients experiencing night-time low blood sugar compared with Lantus® (insulin glargine [rDNA origin] injection). These results were presented today at the International Diabetes Federation 2013 World Diabetes Congress in Melbourne, Australia. The full EDITION II results are consistent with those from EDITION I.1 Both studies were conducted in people with type 2 diabetes already using basal insulin (with mealtime insulin or oral medication). Sanofi also announced the additional top-line results from the EDITION Phase 3 clinical program. The primary endpoint was met in the 6-month EDITION III, EDITION IV and EDITION JP I studies. Full results will be presented at scientific meetings in 2014. "We are encouraged by these results which suggest that U300 could be a viable treatment option for a wide range of people with type 1 and type 2 diabetes." commented Pierre Chancel, Senior Vice President, Global Diabetes, Sanofi. ]]> <![CDATA[CPHI & P-MEC India 2013: India at the centre of global attention of pharma industry ]]> https://biospectrumindia.com/news/95/8124/cphi-p-mec-india-2013-india-at-the-centre-of-global-attention-of-pharma-industry-.html https://biospectrumindia.com/news/95/8124/cphi-p-mec-india-2013-india-at-the-centre-of-global-attention-of-pharma-industry-.html Thu, 05 Dec 2013 12:28:45 +0530 If CPHI and P-MEC (Pharmaceutical Machinery and Equipment Convention) India 2013 is any indication of the shape of things to come, India's pharmaceutical industry is about to explode on world's horizon as a key destination across its entire value chain. Whether it is for formulation, process development or packaging, the players in pharma machinery, technology, ingredients, outsourcing and biopharma segments look to opportunities in globalizing their businesses. CPHI & P-MECIndia 2013 witnessed participation from over 1000 plus exhibitors from 95 countries. The three-day event is likely to be attended by nearly 28,000 attendees from 109 countries. During the event, the industry participants are aiming to put their heads together to leverage India's strengths in moving up the value chain globally at a series of technical seminars and discussions which will be held onsite, over the 3 days of the event. A truly Global Pharmaceutical Event is here. Commenting on the inauguration Joji George, Managing Director, UBM India highlighted the unprecedented interest on India by global pharma industry. He stated that, "It is no longer that India is considered as a mere destination of low-cost manufacturing and low-end bulk drugs. The profiles of international participants reflect that everyone from every known market across the globe is interested in India. Everyone is so keen to leverage CPHI & P-MECIndia this year to grab the opportunity. It is the bus that no one wants to miss". Indeed, the roster of participants reads like a 'who's who' list of global pharma industry. While the global pharma giants like BASF India, Capsugel Healthcare, Ã€urobindo Pharma, Merck Millipore, Indoco Remedies, ACG Worldwide, Bosch Ltd., Fette, IMA Industria Macchine Automatiche S.P.A, Marchesini Group, Truking Technology, Waters India, Agilent Technologies, Shimadzu, Thermo Fisher Scientific, Spinco Biotech, WALDNER Laboreinrichtungen GmbH & Co. KG, Fabtech Technologies International Ltd., Mitsubishi Electric India, Cadmach Machinery Co. Pvt Ltd., Thermolab Scientific Equipments Pvt. Ltd., Hetero Drugs Ltd., UK Trade & Investment, DSM, Evonik Degussa India Pvt. Ltd., etc are present in full strength, there is participation from drug manufacturers, machinery manufacturers and importers from countries such as Ghana, Latvia, Afganistan, Iraq, Burma, etc. High level delegations from Nepal, Vietnam, Sri Lanka, Korea, Turkey and Egypt are attending what would be the biggest gathering of pharma industry in this part of the world. Speaking at the UBM India Pharma Awards last evening, Mr. Satej D Patil, MoS, Home (Urban & Rural), Rural Development, Food & Drug Administration mentioned that, "Maharashtra is very keen to encourage the pharma industry to set up manufacturing and other units here and we are doing everything to facilitate this. I encourage the industry and UBM to submit a white paper both to the central and state government on the major issues and challenges being faced by the industry and we can definitely expect these to be taken up seriously." Mr Patil further added that, "The Indian pharma industry is likely to be one of the top 10 global markets by value by 2020. The emerging markets will be the drivers of the pharma industry growth and we will see a shift back to volume growth as a key measure of performance. The healthy growth reflects the inherent strengths of the industry and improving healthcare standards in the country. Over the years, pharma companies have grown inorganically through acquisitions, but due to higher valuations seen in the sector over the last two years, they have been exploring newer methods of partnerships such as joint ventures and licensing of innovator products and technologies. Companies are focusing on improving operational efficiencies, which have yielded results. Going forward, India should leverage its strengths in the supply of low-cost, quality medicines across the world and play a larger role in the Global pharma market". ]]> <![CDATA[Collaboration on cancer technologies fast becoming a priority]]> https://biospectrumindia.com/news/95/3529/collaboration-on-cancer-technologies-fast-becoming-a-priority.html https://biospectrumindia.com/news/95/3529/collaboration-on-cancer-technologies-fast-becoming-a-priority.html Thu, 05 Dec 2013 11:26:24 +0530 Multimodal Cancer Treatments reached a new high in the four-day Indian Cancer Congress 2013 held for the first time in India, New Delhi. Indian Cancer Congress 2013 boasted of holding discussions of various cancers with experts from various fields on the same platform. This was done with the hope that practices of oncology will adopt the multimodal approach as standard of care. The specially designed round table meetings brought foreign delegates and Indian experts together to help find answers to "India - specific cancers" and their outcomes for example, Gall bladed cancer, cervical cancer and head and neck cancers. Dr.Harit Chaturvedi, Organizing Secretary, Indian Cancer Congress said "Indian Cancer Congress 2013 will act as a catalyst of true integration of clinical and research innovations. With a large input from world leaders in cancer care, we are certain this is going to inspire the new generation towards taking oncology to an international level". One of the other achievements of this conference has been judged by the collaboration of the various cancer related technologies that were displayed in the Congress. New companies demonstrated how new technology molecular and immunopathology can potentially change the landscape of cancer diagnosis and strategies for treatment. The conference, for the first time, demonstrated technology on the forefront with molecular imaging that is likely to change oncology imaging in the future. In the field of radiation, a new technology giving radiotherapy which is affordable, faster, convenient and with less radiation dose while improving effectiveness and accuracy, was uncovered. A very proud achievement for the Indian science community at large was submission of more than 1900 scientific papers and more than 150 awards given to young budding scientists in the field of cancer medicine. "The pace of change has changed in Medicine and oncology is the perfect example of it. Today such meetings help in exchange of ideas and give new directions for future growth. Every question raised, every poster or a thought shared by a young doctor has the potential to give birth to a new concept and give this super specialty it's future direction", expressed Dr (Prof) G K Rath, Organizing Chairman, INDIAN CANCER CONGRESS 2013. On the final day of Indian Cancer Congress 2013 a special session, "Patient Advocacy Program" was organized. Ms Shabnam Singh, Mother of Mr Yuvraj Singh presented her case of battling cancer with Yuvi as a mother rather than as a celebrity. She further added, "The World has entered a new era of technology in growth but we still struggle to find cure for cancer. As a mother of a patient, not a celebrity, I whole heartedly give my support to other patients and their family members. I would like to add that we should all keep our hopes alive and leave the rest to the doctors and gods." The Indian Cancer Congress 2013, being held for the first time, is till date likely to be the largest Asian congregation of Oncologist in Asia. While the congress comprehensively covers all areas of cancer care, it is the field of Psycho-oncology, Onco Pathology and Genomics, i.e. genetic causes and expression of cancers that were given its due platform and for the first time integrated with clinical oncology. The level of contribution and collaboration amongst various fields, from oncologist from different parts of India and the strong faculty of 130 oncologist from abroad, has initiated a new beginning of the state of art tertiary level tumor understanding and patient care in India. In summary this conference put forward a comprehensive programme of precision radiation, personalized medicine and safer surgery from India to the world. "To our delight we met with an amazing response, unparallel energy seen in the academic area and oncotech. The level scientific debates and presentations raised the bar for every other player of the field." Commented Dr (Col) R.Ranga Rao, Chairman, Scientific Committee, Indian Cancer Congress 2013. "Our Vision was to present Indian Oncology to the world as the most rapidly evolving specialty. This will create world leaders in India. We captured the momentum and hope Indian Cancer Congress 2013 will be catalyst for future growth, better care of our patients in all areas- nursing, psycho oncology, rehabilitation. Create platforms for more collaboration at individual and institution level", said Dr Ashok Vaid, Treasurer, Indian Cancer Congress 2013. ]]> <![CDATA[Cadila and Helperby to invest in R&D of antibiotic resistance breakers]]> https://biospectrumindia.com/news/95/6869/cadila-and-helperby-to-invest-in-rd-of-antibiotic-resistance-breakers.html https://biospectrumindia.com/news/95/6869/cadila-and-helperby-to-invest-in-rd-of-antibiotic-resistance-breakers.html Fri, 29 Nov 2013 13:55:39 +0530 Cadila Pharmaceuticals Limited, one of India's largest privately held pharmaceuticals company, and UK-based antibiotics discovery company, Helperby Therapeutics have signed a joint agreement on Antibiotic Drug Resistance Research & Development. Global market size of antibiotics is estimated to be around $69 billion. Described as the most important innovation in the discovery of new antibiotics since Alexander Fleming's original breakthrough more than 80 years ago, this is a major announcement in the fight against resistance with the discovery of patented 'resistance breaker' compounds. These new compounds are called Antibiotic Resistance Breakers. When an Antibiotic Resistance Breaker is combined with an old obsolete antibiotic, it can rejuvenate it and make it active against highly resistant bacteria. Antibiotic Resistance Breakers can potentially rescue several different classes of antibiotics. Furthermore, this approach requires the development of fewer novel compounds, is less risky and less costly than the traditional "one antibiotic" route. Elaborating on this tie up, Cadila Pharmaceuticals' Chairman and Managing Director, Dr. Rajiv I Modi said, "The Founder Chairman of our company, Shri IA Modi, believed in providing affordable medicines for the masses through innovative and cutting-edge research & development (R&D). This discovery will open new avenues against resistant organisms and is very timely in view of global concerns about rapidly growing bacterial resistance against current antibiotics. Cadila Pharmaceuticals' collaboration with Helperby can help the mankind win the battle against the microbes and hopefully save millions of lives in coming years." Helperby signed its first major licensing deal with Indian pharma giant Cadila Pharmaceuticals to take the compound through further clinical trials, approvals and into commercialisation. Helperby will supply Cadila Pharmaceuticals Ltd. with Antibiotic Resistance Breakers whilst Cadila Pharmaceuticals Ltd. will develop the combinations with old antibiotics. Helperby, a spin-out of the UK's University of London, St George's Hospital has been working for the past 12 years on ways to tackle antibiotic resistance and has discovered a new series of potent, fast-acting drugs which rescue old antibiotics. Instead of targeting multiplying bacteria, the research team focused on non-multiplying, dormant bacteria. Developing antibiotics that specifically target these root-like bacteria has never been done before - in fact conventional methods of screening have consistently missed these promising candidate drugs. ]]> <![CDATA[UK partners with BioAsia to bolster ties in biotechnology]]> https://biospectrumindia.com/news/95/6040/uk-partners-with-bioasia-to-bolster-ties-in-biotechnology.html https://biospectrumindia.com/news/95/6040/uk-partners-with-bioasia-to-bolster-ties-in-biotechnology.html Fri, 29 Nov 2013 11:22:00 +0530 The event will address aspects relating to the increasing disease burden, the need for more efficacious and affordable healthcare solutions, innovative products and operating models that could optimise R&D cost while increasing efficiencies, and innovative financing models. Commenting on the developments, Mr Shakthi M Nagappan, CEO, BioAsia, said, "We are glad to have UK as our partner. India and UK have lot to offer to each other in the lifesciences sector. Both the countries understand the importance of innovation in lifesciences, which is also our theme for BioAsia 2014. Overseas organisations own more than 35% of patents in the UK compared to 12% in the USA, and less than 4% in Japan. So we are sure this association will prove fruitful for both the parties." "Britain and India are natural cultural, social, commercial and scientific partners. Our aim is to build a stronger, wider, deeper relationship based on shared culture, values, and strategic interests... UK and India have inherent strengths in lifesciences and bringing them together will drive significant developments in the lifesciences and healthcare sector," opined Mr Andrew McAllister, British Deputy High Commissioner. Mr McAllister pointed that efforts are being made to make it more attractive for companies to invest in UK innovation through the introduction of schemes like, the Patent Box, which from April last year has a 10% rate of corporation tax for profits attributed to patents; improving R&D Tax Credits for SMEs; and creating enabling regulatory environment. Mr K Pradeep Chandra, Principal Secretary, Department of Industries, Government of Andhra Pradesh, expressed, "UK is by far the most popular business destination in Europe for Indian companies. Out of the 1200 Indian firms in Europe, 700 operate out of the UK. A number of Hyderabad-based lifesciences and pharmaceuticals companies have set up successful businesses in the UK and are growing. Examples include Dr Reddy's, Aurobindo Pharma, Vivimed Labs, and Nandan Biomatrix among others. The biotechnology sector is one of the fastest growing knowledge-based sectors in India. So definitely there is ground for cooperation and synergy." "Joint investment in research has increased substantially over the last 3 years, making it the fastest growing bilateral research relationship for the UK.The portfolio of agreed joint funding on research now totals £150 million, up from just £1 million four years ago," Mr McAllister further added. ]]> <![CDATA[Baxter advances clinical practice of intravenous (IV) therapy with launch of Plasma-Lyte A in India ]]> https://biospectrumindia.com/news/95/8451/baxter-advances-clinical-practice-of-intravenous-iv-therapy-with-launch-of-plasma-lyte-a-in-india-.html https://biospectrumindia.com/news/95/8451/baxter-advances-clinical-practice-of-intravenous-iv-therapy-with-launch-of-plasma-lyte-a-in-india-.html Thu, 28 Nov 2013 17:44:00 +0530 Baxter India, a subsidiary of global healthcare company, Baxter International Inc, has announced the launch of Plasma-Lyte A (pH 7.4), a physiologically balanced crystalloid solution, having similar electrolyte constitution to that of blood plasma. Plasma-Lyte A advances the clinical practice of IV Therapy in India for critically ill patients especially in the ICU where the selection of the right IV fluids can help avoid complications, morbidities and mortality1, 2. Plasma-Lyte addresses these clinically unmet needs and issues, bringing a balanced solution with sodium, potassium, magnesium and chloride levels similar to plasma7. The absence of calcium in the solution means, it can be administered before, during or after blood transfusion 6. Plasma-Lyte does not exacerbate metabolic acidosis, nor does it complicate the evaluation of metabolic acidosis 13. Plasma-Lyte reduces the risk of hyperchloremic acidosis compared to those receiving normal saline and does not adversely affect acid base status 1,2,3,4,5,8. Currently administered IV fluid therapies in India include Colloids (6% hydroxyethyl starch, albumin) and Crystalloids (Ringers Lactate, Ringer's Acetate, Normal Saline). Fluid resuscitation with normal saline encompasses high levels of sodium and chloride and can result in detrimental clinical outcomes by causing hyperchloremic metabolic acidosis, reduced renal perfusion, and immune dysfunction, especially in major surgery1,5 .Some other balanced crystalloid solutions like Lactated Ringer's solution cannot be co-administered with citrate preserved blood, as the calcium affects the anticoagulant properties of citrate 6. Large volume infusion of Ringer's lactate can also lead to complications of hyponatremia and acidosis as seen during major spine surgery9. Hydroxyethyl starch (HES), a commonly used colloid in fluid therapy in critically ill patients, is associated with serious safety issues leading to increased need for renal replacement therapy, increased mortality and higher risk of kidney dysfunction 10, 11. Dr. Ashok Moharana, Director, Medical Affairs, Emerging Asia says, "Studies show that 17% of post-operative patients develop morbidity directly related to fluid prescription and errors in fluid prescription common in hospital practice, are a major safety concern3,4. Plasma-Lyte A is a physiologically balanced electrolyte solution that addresses the unmet medical need of having a fluid that has similar electrolyte constitution to that of plasma7. This will help to optimize standards of care in clinical practice of IV fluids therapy in India, thereby improving clinical outcomes in patients care. ]]> <![CDATA[World Vision India urges for the passage of pending HIV bill]]> https://biospectrumindia.com/news/95/4883/world-vision-india-urges-for-the-passage-of-pending-hiv-bill.html https://biospectrumindia.com/news/95/4883/world-vision-india-urges-for-the-passage-of-pending-hiv-bill.html Thu, 28 Nov 2013 16:34:57 +0530 Year after year stories of people living with HIV (PLHIV) being discriminated, tortured and going through unspoken sufferings had surfaced and documented by many including social activists, NGOs and media. In 2006, their hard struggle and cries of many PLHIVs were recorded in the consultations and finalisation of an important bill yet to be passed, the 'HIV pending bill'. The fight to make it pass in the parliament has been tougher since than generating the reasons to formulate it. There has been a step forward in the year 2006 when it was agreed that HIV and AIDS has long gone past being a medical problem and is now an issue that cuts across social, economic, psychological, medical, and human rights parameters and needs to be addressed at a war footing. On December 01, yet again World Vision India reinforces along with communities and PLHIVs to not only observe World AIDS Day, but amplify our voices to urge national leaders to 'Walk Together' with PLHIVs and pass the HIV Bill that will protect their rights. It is time we respect and give proper direction to the Bill that was drafted after nation-wide consultations with different stake holders including PLHIVs, communities at risk of HIV, healthcare workers, children's organizations, women's groups, trade unions, lawyers, and State AIDS Control Societies. Stating the urgency of the need for the Bill, Dr. Jayakumar Christian, National Director, World Vision India said, "Statistics don't bleed, but people bleed. In our work with around 40,000 children affected by HIV and AIDS across the country, we have seen them and their families denied their right to dignified life and treatment because of the stigma attached to the disease. A legal protection would go a long way in ensuring that these children are able to access their rights". World Vision India along with partners have been conducting grassroots level consultations as well as state level forum to discuss the bill and create empowered voices for community based solutions and work towards Zero discrimination towards PLHIVs. "The passing of the long pending HIV and AIDS bill in its original form will contribute to reducing the epidemic and will also protect the rights of people living with HIV, including children affected and infected. The PLHIVs in this country are not legally protected which means we do not have a legislation/Act passed yet to protect their rights. The greatest need of the day is to pass the bill incorporating all the provisions necessary for the protection of their rights." Mr. Reni Jacob, Advocacy Director, World Vision India, further added. Let's Walk Together WThis December 1, 2013 on World Aids Day, Let's take a walk together and meet Daisy David, the first woman in India to raise her voice for free distribution of ART, Anti-Retroviral Therapy. Hear her story: Daisy David is a loving mother, an advocate, counselor, social activist and a PLHIV. While working in the Gulf region as a Lab Technician in 1998, she was accidentally diagnosed as HIV+. Staying in a far way and different country, she battled the trauma all alone. Back home she was alienated from her family. But after her husband died she was reunited with her daughter. Today, she takes care of her college going daughter and also her in-laws. Daisy: "I stay alone and not with them. Because I am (HIV) positive, my relatives and those in my neighborhood keep a distance from me. I don't want my daughter to feel discriminated against because her mother is positive. That is why I stay away. I long to live with my daughter; hug her, kiss her, but I keep a check on all my emotions. When I am with other HIV+ people like me, I feel happy and confident but once I face the outside world, I lose all my confidence. Many women who are afflicted with HIV virus face such discrimination. They are denied their husband's property, they are not allowed to attend family functions, and they are abused. At the same time, they have to bear the burden of the family." "When we first started talking about the HIV/AIDS Bill, we were talking about how our children needed to be taken care of. Today, those children are adults waiting to be married, and have a different set of problems, but there is no law yet," adds Daisy David. There are thousands of Daisy's who wait in anticipation that this Winter session of Parliament will bring a ray of hope to those affected and infected with HIV and AIDS. ]]> <![CDATA[ I am not anti biotech industry says Dr Shiva]]> https://biospectrumindia.com/news/95/5707/-i-am-not-anti-biotech-industry-says-dr-shiva.html https://biospectrumindia.com/news/95/5707/-i-am-not-anti-biotech-industry-says-dr-shiva.html Thu, 28 Nov 2013 16:12:00 +0530 In a recent interaction with Dr Vandana Shiva who is more often known as a firece anti-GM activist, BioSpectrum tried to know the other side of the story. Happy reading! â– Are you against all kinds of GMOs? Given the use of genetic engineering in pharma can be crucial for fighting many diseases, don't you think that opposing it is grossly unfair to patients? Dr Shiva: Let me make this thing clear that I am only against the usage of GM in agriculture. I am not against the biotech industry or other non GM technologies associated with it. I feel that we are unnecessarily pushing for it. Leaving enough space for all to thrive freely and biodiversity has been embedded in our culture. There can be no debate on this fact. Incorporation of monoculture in agriculture, has over the period of time, given rise to increased rice production but at the cost of ignoring the millets. In Punjab, the biodiversity has suffered because of green revolution. I believe that those propagating Bt cotton as success, are not doing justice as the bollgard worm against which it was said to be effective, has become resistant. People like Ms Kiran Mazumdar make drugs that are very much within the containment. These are such that it doesn't affect the larger environment. On the medicine part, I am not competent enough to draw any parallels with agriculture. But I am a scientist and can evaluate the claims made about the benefits offered by GM products in agriculture. And my analysis has been that we must not allow it without enough satisfactory biosafety tests. â– What are your concerns with the biosafty? How do you justify your opposition? Biosafety is very important in agriculture as the products like Bt brinjal and Bt Cotton can affect the biodiversity beyond repair. The scientist claim three major points over the usage of genetic engineering in agriculture. The one is it will in crease yield. That has been demolished when we saw the decrease in yield or no such visible in crease in Bt cotton. Second is that the pesticide usage shall decrease. That too is not justified given the experiences. Third is that it will improve farmers lives. It has not been done not even in America. They haven't passed the bioequivalence tests. In Europe, it has happened to some extent in Europe but wherever it has happened, there are reports of organ collapse, liver shrinkage, toxins resulting in aberration alongside intestine. In America, there is something called a lee-chi gut syndrome. The pesticide spraying has increased, leading to the still baby births and spontaneous abortions in American states. Remember the warning by Dr Don Huber, who wrote a letter to US regulators, warning of the discovery of a new pathogen and a possible link between Roundup Ready (GMO) corn and soybeans and severe reproductive problems in livestock as well as widespread crop failure. In India, the Bt cotton was illegally cultivated in 1998 onwards and then it also received support from few people who benefited in long run. There were 694 farmer suicides due to it. Farmers were left with no choice. Even Supreme court appointed committee and parliamentary standing committee have recommended the biosafety tests for ten or more years. On that note, we need more biosafety labs than a biotech regulatory authority. Our agriculture minister, Mr Sharad Pawar, tried to frame laws unilaterally but we have and will oppose any such move at all the levels. I was called to attend a meting by the biotech industry and when I asked about the lack of biosafety tests, someone remarked that we cannot wait for more, as we will lose out on revenue and competition. My favorite line for GMO's is 'God Move Over.' â– How do you look at the approval of Bt brinjal in Bangladesh and its impact on India? Our then environment minister, Jairam Ramesh did public hearings on Bt brinjal issue and finally did what he thought was more important. The moratorium continues and I feel deliberate release must not be done. Let the research continue in labs on all aspects including biosafety. The implications of the Bangladesh approval will happen due to the porous border conditions with India. States such as Bengal and Orissa are the top cultivators of the brinjal, and the close proximity will certainly have an immediate effect. This will become a way of illegal cultivation. It has been a part of Monsanto's strategy everywhere, so that eventually pressure is built to legalize it. Its is a trap and my like minded colleagues are working to do do everything possible to tackle it. â– Don't you think its better to clear the mistrust between both activists and scientists who too are an important part of society? Not all the scientists are for the release of GM in the environment. I am a part of 250 strong scientist forum that has written to the prime minister. I don't believe it to be a debate between scientists and activists. It is making a choice between manipulated science and what is right for humanity. Shift to the low intensity, income organic farming. The supreme court has combined many cases on GMOs Dr Paroda became independent reporter. That is when the civil sociey is stronger. â– What about ensuring food security through increased food production by technological means? Increase in the production cannot only be achieved through genetic engineering. There are enough other means that can be explored. As far as food security is concerned, all of these things are in a flux. On one side, we say that decentralization of food business is a must, there are people who want to control it. The biggest loophole is that the food security bill is that it didn't ensure that food-grains be procured directly from farmers. That is why we say that the farmers who will give away all their produce, must be compensated appropriately. Improvement in distribution system is more important. ]]> <![CDATA[OPPI Conclave focuses on attracting young talent to the pharmaceutical industry]]> https://biospectrumindia.com/news/95/8197/oppi-conclave-focuses-on-attracting-young-talent-to-the-pharmaceutical-industry.html https://biospectrumindia.com/news/95/8197/oppi-conclave-focuses-on-attracting-young-talent-to-the-pharmaceutical-industry.html Thu, 28 Nov 2013 12:06:09 +0530 The Organisation of Pharmaceutical producers of India (OPPI) hosted an HR Conclave today on "Talent Attraction - Engaging Gen Y" to address the human resources challenge in the pharmaceutical sector . The event brought together industry stalwarts, multinational pharmaceutical companies, distinguished academicians and HR leaders from pharmaceutical and allied sectors. The pharmaceutical industry is a knowledge-based industry, which is growing steadily and plays a major role in the Indian economy. The country's emergence as an important manufacturing base as well as a market for the global pharmaceutical industry, makes this an attractive sector for young professionals in a wide range of specialties involving drug development, marketing, project management and technology. The pharmaceutical industry currently employs approximately 4,50,000 people and has contributed significantly in creating a rich talent pool of researchers, scientists, doctors and project managers. Addressing the gathering, Ranjana Smetacek, director general, OPPI said, "Gen Y, or the 20-30 age group, today constitutes a major part of the country's workforce and will bring us tomorrow's leaders. The pharma industry also needs to retain and nurture existing talent and equip young workers with the skills and knowledge, necessary for a better understanding of emerging challenges and opportunities." The key-note speaker, Dietmar Eidens, executive vice president, Merck Serono said, "Globally as well as in India, the pharmaceutical industry is rapidly undergoing changes. The pace of this transformation has made it important to invest in developing young talent and adapting to their needs. As Generation Y begins to play a more important role in the workforce, the pharmaceutical industry will also need to adjust to the challenging workplace dynamic and cultivate a strong image as an 'employer of choice' ." The pharmaceutical industry in India has clocked double digit growth rate in the last five years and this is expected to continue in 2014. With several multinational companies operating in this space there are more jobs in the pharmaceutical sector and a great scope for hiring. Dr Shailesh Ayyangar, president - OPPI and managing director, India and vice president, South Asia, Sanofi, added "The very nature of the pharmaceutical business - treating patients and providing integrated healthcare access - will certainly go a long way in meeting key career aspirations of Gen Y, looking for 'social value' and 'instant gratification' in what they do. Furthermore he mentioned, "Our sector has an edge over others having proven resilience during the economic downturn. Stronger focus on patient well-being; a steadily growing population, per capita income and government expenditure; are promising in terms of potential and experience, for those who are establishing their careers." ]]> <![CDATA[ Innovative organic plant growth regulators launched ]]> https://biospectrumindia.com/news/95/5650/-innovative-organic-plant-growth-regulators-launched-.html https://biospectrumindia.com/news/95/5650/-innovative-organic-plant-growth-regulators-launched-.html Wed, 27 Nov 2013 17:50:42 +0530 Tata Chemicals has undertaken mass farmer awareness programes and fram level demonstration in key target markets to explain the key features and benefits of the products, by offering first-hand user experience. The higlighting feature of FarmGro is that it helps in the conversion of proteins. Along with this increases the flowering, pod formation, yield as well as the metabolic function. The unique feature of FarnGro is that it can me mixed with all commonly used pesticide. Maintaining the environment friendly mantra it is completely biodegradable and toxin free certified by Ved Organic Certification agency. FarmGro G is a granular product meant for soil application, which enables application of plant growth substances through soil route. This product is enriched with - mycorrhiza which facilitates faster nutrient uptake by the plant. FarmGro G aids in the nutrient uptake of the plant from soil, produces uniform seedling. Simultaneously plays a vital role in nutrient cycling and is more tolerant to adverse soil chemical constraints which limits crop production. Apart from this increases plant resistance to diseases and drought and stimulates the growth of beneficial microorganisms. It is also toxin free and certified by agency. Speaking about this launch Mr. D K Sundar, Senior Vice President, Crop Nutrition and Agribusiness, Tata Chemicals, stated, "The introduction of PARAS FarmGro and FarmGro g is based on an in-depth understanding of farmers' requirements where we found a clear need for a high quality organic offering in this space. the FarmGro products have been designed to address this need and enable the farmer to efficiently use organic products for improving nutrient uptake and crop productivity." ]]> <![CDATA[Biocon's Transtuzumab receives marketing authorization in India]]> https://biospectrumindia.com/news/95/4449/biocons-transtuzumab-receives-marketing-authorization-in-india.html https://biospectrumindia.com/news/95/4449/biocons-transtuzumab-receives-marketing-authorization-in-india.html Tue, 26 Nov 2013 17:49:00 +0530 Trastuzumab will be marketed in India under the brand name of CANMAb by Biocon, and is expected to be available to Indian patients in Q4 FY14. Trastuzumab is also the world's first biosimilar version of 'Herceptin' to be brought to the market. Every year, over 100,000 new breast cancer patients are diagnosed with this disease. The cost of biologics in cancer treatment is extremely high which makes access unaffordable to a large patient pool. Speaking on the occasion, Ms Kiran Mazumdar Shaw, CMD, Biocon, said, "This is a major milestone for both partners as it is the world's first biosimilar to be accorded regulatory approval. We plan to make CANMAb available to Indian patients in Q4 FY14." Ms Shaw further added, "The meticulous development of this important cancer drug has involved extensive product characterization and clinical trials to demonstrate comparability and similarity in PK (pharmacokinetic), safety, efficacy, and immunogenicity against the innovator product. We are committed to affordable cancer care and believe that Trastuzumab will expand patient access to this life saving drug. The Indian approval is an encouraging milepost as we plan to leverage this data to support regulatory filings in several countries across the globe." Trastuzumab is expected to offer an alternative affordable option, thereby enhancing access to treatment for cancer patients in India and the world over said the press release on Tuesday. The global sales for Trastuzumab stood at US$ 6.4 billion in 2012, while in India it recorded sales of approximately US$ 21 million. Since 2009, Biocon and Mylan have been involved in co-developing of biosimilar monoclonal antibodies and complex biologics comprising, Trastuzumab, Pegfilgrastim, Bevacizumab, Adalimumab and Etanercept. The Innovator product sales of these products in 2012 were pegged at US$ 34 billion. The patent expiry of these products in regulated markets is expected from 2015 onwards. In 2013, this partnership was extended to co-development of biosimilar Insulin analogs for the global markets. The overall global opportunity for biosimilars is estimated to be US$ 22 billion by 2020. ]]> <![CDATA[Merck Millipore Process Solutions India launched second edition of 'EMPROVE Seminar Series' in Mumbai]]> https://biospectrumindia.com/news/95/7655/merck-millipore-process-solutions-india-launched-second-edition-of-emprove-seminar-series-in-mumbai.html https://biospectrumindia.com/news/95/7655/merck-millipore-process-solutions-india-launched-second-edition-of-emprove-seminar-series-in-mumbai.html Tue, 26 Nov 2013 17:46:36 +0530 Merck Millipore, the Life Science division of Merck, organized the second edition of 'EMPROVE Seminar Series' at the Tal Lands End, Mumbai. The seminar by Merck Millipore offered Indian pharmaceutical industry a platform to getting access to the latest trends and developments in the international regulatory arena. This year's theme, 'stability in turbulent times', addresses the challenges faced by the industry. Dr Claus-Dieter Boedecker, managing director - Merck (India) and head, Merck Millipore (India) said, "Today the pharmaceutical industry in India is grappling with challenges owing to an uncertain and ever-changing regulatory environment. It is imperative for our industry to understand, interpret and prepare to meet the challenges of tomorrow. Through the EMPROVE Seminar Series, our focus and commitment is to help customers understand the changing regulatory scenario and negotiate in such market dimensions. With EMPROVE Merck Millipore establishes itself as leaders in Quality and International Regulatory Compliance." The topics discussed ranged from potential solutions to challenges faced by exporters to regulated markets; stumbling blocks faced while making abbreviated new drug applications and how to overcome them; quality standards and certification available to grade pharmaceutical excipients in the current regulatory scenario. Mr Peter Salazar, head of the pharma chemical solutions, Merck Millipore (India) and pioneer of the EMPROVE Seminar Series said, "The 2013 edition of EMPROVE Seminar Series helps gain better insights into the rapidly evolving global regulatory scenario for improving stability of the pharmaceutical industry in such turbulent times. Merck Millipore's customer-friendly EMPROVE products and services, along with providing regulatory support offers information on greater product safety, cost and time savings." Mr Tapan Ray, former president, OPPI and Independent Pharmaceutical industry analyst and consultant, addressed the seminar on 'Challenges in Pharmaceutical Exports for Regulated Markets and Potential Solutions'. Mr Ray stated, "I am happy to be associated with the second edition of the EMPROVE Seminar Series. The setbacks on the regulatory front this year have adversely impacted advancements in drug manufacturing processes and technology. In such scenario, pharmaceutical companies will need to focus their attention on appropriate corrective measures in this area sooner and the EMPROVE Seminar Series helps discuss and resolve regulatory challenges and provide solutions to the industry." The seminar was inaugurated by Dr Claus-Dieter Boedecker, MD - Merck (India) and Head - Merck Millipore (India)and Mr Tapan Ray, former president - OPPI and independent pharmaceutical analyst and consultant.At the seminar, Dr Najib Sehat, head global regulatory management, Merck Millipore and Member - EXCiPACT Global Steering Committee spoke on Pharmaceutical Excipient Quality Standards and Certification in the Current Regulatory Environment. Other leading experts who spoke at the seminar included Mr. Dhiraj Chopra, associate director, Dr Reddy's Laboratories Limited; Mr Amit Bansal, managing partner, Resolute IP and Legal Solutions; Ms Meena Kashyap-Shah, Sr manager, Regulatory Affairs, JB Pharmaceuticals; and Dr. Christian Dittrich, Global marketing manager - Bioavailability Enhancement, Merck Millipore. ]]> <![CDATA[Drought tolerant maize to insure farmers from crop failures]]> https://biospectrumindia.com/features/95/4671/drought-tolerant-maize-to-insure-farmers-from-crop-failures.html https://biospectrumindia.com/features/95/4671/drought-tolerant-maize-to-insure-farmers-from-crop-failures.html Tue, 26 Nov 2013 17:13:00 +0530 Maize is mostly grown as a rain-fed crop in India, and during Kharif season every year, out of which nearly 60 percent of the area is sown. In most of the areas, expansion happens in Kharif season, since Kharif is considered as the most favorable season for maize. However, Kharif season crops are mostly vulnerable to drought conditions because of scanty rains coupled with poorly distributed rainfall patterns. Development of drought tolerant maize is an important need for helping India to stabilize maize production, and insure farmers from total crop failure. In this project, the main objective was to identify candidate gene markers for further development of breeder ready markers for traits of interest and identification of inbred lines with enhanced pace and ultimately develop drought tolerant hybrids. The project was initiated in December 2012. This project has been in collaboration with CIMMYT with DBT's assistance on association mapping and whole genome MARS for the development of abiotic stress resilient Maize. Dr Vivek and Dr Girish Krishna from CIMMYT and Dr B Muralidhara Rao from GEO Biotechnologies had initiated this project. The project was aimed at bringing in drought tolerant hybrid maize seeds and develop drought tolerant maize hybrids which can be commercially sold to the farmers. The outcomes and the methodology adopted in this project will benefit research in the area of developing drought tolerant crops in the future. Mr KS Narayanaswamy, chairman and CEO, GEO Biotechnologies India, said, "Public-private partnerships will go a long way in the development of biotech industry in India. Better quality of work, application of technology, and efficient use of infrastructure have been the benefits. The partnerships are only recent in many cases, and the outcomes will enhance the associations to a greater extent over a period of time." At present, evaluation of the test crosses obtained by crossing 325 CIMMYT-inbred lines and 75 GEOinbred lines with two testers is in progress at five locations, namely Motebennur, Dharwad, Bangalore, Warangal and ICRISAT, Hyderabad. Leaf sample analysis for cellular level tolerance, waxy layer, C and O isotope discrimination is underway. The leaf samples have already been sent for outsource genotyping using 55K chip. The estimated total project cost across all phases has been about `140 crore. The initial funding amount approval of `14.29 crore was received collectively by GEO and CIMMYT. The funding has helped GEO in meeting the total expenditure on phenotyping cost by testing the test crosses in multi-location sites corresponding to various varying agro-climatic conditions. The project had Dr KS Narayanaswamy, CMD, GEO Biotechnologies, receiving project support from Dr CS Prakash, plant biotechnology professor, Tuskeegee University, USA. The team also consisted of Dr B Muralidhara Rao, GM (R&D), GEO Biotechnologies, having more than 26 years of experience in maize breeding, Dr BS Vivek, senior maize breeder, CIMMYT, Hyderabad, who has been working at CIMMYT, Mexico, for the last 20 years in maize breeding, and Dr Girish Kumar Krishna, maize molecular breeding scientist, CIMMYT, Hyderabad. CIMMYT being a CGIAR institute and this was a new collaboration, the project had issues of IP and fund transfer before signing the MoU, which was resolved with the intervention of DBT. During the project course, it was difficult for researchers in finalizing suitable farmers' fields for conducting multi-location testing of test crosses. Association of a progressive farmer in each test location was considered all the more important for this purpose. However, this task was made easy through the help of field staff. The economic significance of this project is evaluated in three paradigms. The farmers will receive higher yields in growing maize during adverse climatic conditions. The research will also contribute in terms of food security aspect of the country, ensuring grain productivity, and provision of fodder for animal husbandry activities during inadequate rainfall. Also, the overall increase in maize growing areas can also be attributed as farmers who would previously not prefer to grow maize because of higher water consumption can look at the crop as a viable option. This proposed project will also lead to identification of candidate gene markers for further development of 'breeder ready' markers for traits of interest and also identification of inbreds with enhanced pace. The proposed approach would help in identifying practically usable markers for development of inbreds, and ultimately hybrids meeting the farmers'and seed industry needs. GEO has also collaborated with University of Agricultural Sciences (UAS) Bangalore, for developing tomato hybrids with fruits having higher shelf life. The Small Business Innovation Research Initiative (SBIRI) has been approached for funding of the project. GEO is also looking forward for its projects in rice and sunflower, which are at a conceptual stage for a PPP with BIRAC. ]]> <![CDATA['For how long will we ignore science?' asks Dr Pental ]]> https://biospectrumindia.com/news/95/8232/for-how-long-will-we-ignore-science-asks-dr-pental-.html https://biospectrumindia.com/news/95/8232/for-how-long-will-we-ignore-science-asks-dr-pental-.html Mon, 25 Nov 2013 17:57:00 +0530 In a recent interaction with the BioSpectrum, Dr Deepak Pental, professor, department of genetics, University of Delhi, opined that Indian politics has overtaken the longterm interests of Indian scientific as well as farming community. He explained, "It will be downright foolish to ignore how things have progressed even in Bangaldesh vis a vis Bt brinjal. We keep on typing knots and untying them will take a lot of time. So far we have not released anything in proper fashion. Even those who demand ban on all GM crops for the future, are not talking about BT cotton. It will be unfortunate that if Bt brinjal comes in under clandestine circumstances and finally illegal cultivation without proper segregation happens, making the government to accept the facts later." In a rather very straightforward way, Dr Pental asked few hard hitting questions to those who oppose GM. "Why is Genetic Engineering Apprisal Commitee (GEAC) not being allowed to function? Afterall nobody is suggesting that government is not the final authority. But in this case, when there are three ministries and beaurucrats on one side and one ministry on the other side, this is enough to point towards the passage of BRAI bill,"he mentioned and went on asking, "Who would like to work in this area when we first fund it and then don't care enough later? How long will we ignore scientists and science for politics? We don't work as team and that has resulted in so much choas." Dr Pental recalls that during the times of green revolution even Dr Swaminathan was accused of biopiracy by certain sections of society but the unrelenting attitude of policymakers made it happen. "Even some ideologies were bitterly opposed as they didn't want the alleivation of hunger, fearing the loss of poverty will bring their end. Same spirit continues within section of them even today without having anything to do with technical understanding of subject or looking at the bigger picture", he concluded. ]]> <![CDATA[Quintiles bags 'Best CRO' title]]> https://biospectrumindia.com/news/95/6676/quintiles-bags-best-cro-title.html https://biospectrumindia.com/news/95/6676/quintiles-bags-best-cro-title.html Mon, 25 Nov 2013 17:44:00 +0530 "Scrip's 'Best CRO' Award is designed to acknowledge the critical role that CROs play in drug development, and is always a very fiercely fought category. Quintiles impressed our judges to claim the trophy for the second year running, with its commitment to innovation, particularly, with Infosario Safety System. It remains the CRO to beat," said Mr Mike Ward, chief content officer for Datamonitor Healthcare and Scrip Intelligence, the sponsor of Scrip Awards. Also, the Best Technological Development in Clinical Trials Award recognized Quintiles' Infosario Safety System. On this, Mr Richard Thomas, CIO, Quintiles, commented, "We're delighted to receive this recognition for Quintiles Infosario Safety - the result of our vision to provide a common drug safety platform for the industry. Adding best practices and Quintiles' deep development expertise makes this platform truly transformational." Mr Ward further added, "Scrip's best technological development in clinical trials award recognizes the fundamental importance of using the most sophisticated platforms to leverage data captured during clinical studies. With Infosario Safety System, Quintiles was one of 13 other entries and the judges recognized the company's cross-industry thinking in designing a product that the whole industry could use, as well as its cost savings and the step forward in patient safety that it delivers." Commenting on the occasion, Quintiles' president of clinical development, Ms Paula Brown Stafford said, "It is an honor to be recognized once again for our sustained leadership in the sector. I'd like to dedicate this prestigious award to Quintiles' employees worldwide - the true foundation of our business." The Scrip Awards acknowledge excellence in the biopharmaceutical industry, judged by an independent panel of 15 life sciences experts. The 9th annual awards ceremony was held in London, UK. ]]> <![CDATA[Bt Cotton seed manufacturing companies in turmoil]]> https://biospectrumindia.com/features/95/2954/bt-cotton-seed-manufacturing-companies-in-turmoil.html https://biospectrumindia.com/features/95/2954/bt-cotton-seed-manufacturing-companies-in-turmoil.html Mon, 25 Nov 2013 17:16:00 +0530 The Bombay High Court's decision in September this year strongly upheld the validity of Maharashtra Cotton Seed Act, 2009, raising questions about the stability of Bt Cotton seeds prices. The state of Maharashtra and Andhra Pradesh have severely faced the heat of this regulation. The Bt cotton seed price control is in implementation in Maharashtra since 2008 onwards, through ordinances before the Act was lawfully passed in 2009. Under the act, the government reserves and holds full rights in regulating the Bt cotton seed prices. The Act also says that seed companies need to pay compensations to farmers if the seeds fail to produce the necessary yields as expected. At times, the prices were at fully financially viable levels to the seed industry, thereby strengthening seed manufacturers financially. Bt cotton offers the highest revenue to the seed industry, which is estimated to be `7,000 crore. It is grown in many states including Andhra Pradesh, Gujarat, Maharashtra, Haryana, Karnataka, Madhya Pradesh, Punjab, Rajasthan and Tamil Nadu. The state of Gujarat had a similar Act passed, but it was later set aside by the High Court of Gujarat. Currently, all other states, except Maharashtra and Andhra Pradesh, do not have any cotton seed price control enactments. In India, significant seeds makers include Nuziveedu Seeds, Ankur Seeds, Mahyco, Rasi Seeds and Krishidhan. The Bombay High Court's ruling in this regard will irreversibly affect the seed production process. Says Mr M Prabhakar Rao, chairman & managing director, Nuziveedu Seeds Limited, "The Hon'ble High Court has mentioned that when there is price regulation, it will be the duty of the regulator to maintain financially viable pricing to the Industry." Indian seed industry being the sixth largest in the world, the country has become the second largest producer and exporter of cotton in the world. In other words, the judgment has made it clear that while the government, which should take care of farmers interest is also obligated to take care of the industry's financial viability and provide for adequate return on investments. Therefore, if the government follows the spirit and letter of the order, industry can expect price corrections every year in line with the cost escalation. If this is achieved, the outcome can be positive. ]]> <![CDATA[IHME launches Roux Prize]]> https://biospectrumindia.com/news/95/3518/ihme-launches-roux-prize.html https://biospectrumindia.com/news/95/3518/ihme-launches-roux-prize.html Mon, 25 Nov 2013 16:34:22 +0530 The Institute for Health Metrics and Evaluation (IHME) at the University of Washington has launched the Roux Prize, a new US$100,000 award to recognize individuals or groups that have used Global Burden of Disease (GBD) data to take action that makes people healthier. The prize is named for David and Barbara Roux. David Roux is a founding board member of IHME. Over the past decade, he has encouraged the Institute not to let GBD data sit on a shelf and go unused but to look for ways to make it accessible and useful. Nominees may come from anywhere in the world and could include, but are not limited to, staff in government agencies, researchers at academic institutions, volunteers in charitable organizations, or health providers working in the community. Nominations are due March 31, 2014, and the winner will be announced at an event in September 2014. The Roux Prize is intended for anyone who has applied Global Burden of Disease research in innovative ways to improve population health since the first GBD publication in 1993. The winner will receive US$100,000, making the Roux Prize the largest award focused on individuals contributing to population health. "Dave Roux's commitment to IHME has long inspired us to look for ways to bring GBD to the wider public beyond our core audiences of policymakers, researchers, and others working in population health," said IHME director Dr Christopher Murray. "The Roux Prize can transform the way that data are used to drive action that will have lasting health impact." GBD is a systematic, scientific effort to quantify the comparative magnitude of health loss due to diseases, injuries, and risk factors. In 1993, the original GBD study was funded by the World Bank and featured in its landmark World Development Report 1993: Investing in Health. Co-authored by Dr Murray, this study included estimates for 107 diseases and 483 non-fatal health consequences in eight regions and five age groups. GBD 2010, a collaborative effort with almost 500 co-authors led by IHME and published in The Lancet in 2012, provides results for 291 diseases and injuries, 67 risk factors, and 1,160 non-fatal health consequences for 21 global regions, 20 age groups and both sexes, and 187 countries. Theresults are available in a series of online data visualization tools at http://ihmeuw.org/GBDcountryviz. In 2014, IHME will begin publishing annual updates of the GBD estimates. "IHME has led the way in promoting the idea that dramatic change is possible through better understanding of health challenges based on rigorous data," said Michael Young, president of the University of Washington. "The Roux Prize will honor current and up-and-coming healthleaders who emulate this approach." Data on disease burden have led to changes on a variety of health issues, ranging from global tobacco control to better diagnosis and treatment of children with diabetes in Ghana to laws in Vietnam encouraging helmet use among riders of motorcycles and bicycles to reduce road injury deaths. Details on the nomination process and criteria are available on the IHMEwebsite at www.rouxprize.org http://www.ihmeuw.org/rouxprize. ]]> <![CDATA[Gilead attempt to secure patent on hepatitis C drug opposed in India]]> https://biospectrumindia.com/news/95/3521/gilead-attempt-to-secure-patent-on-hepatitis-c-drug-opposed-in-india.html https://biospectrumindia.com/news/95/3521/gilead-attempt-to-secure-patent-on-hepatitis-c-drug-opposed-in-india.html Mon, 25 Nov 2013 15:04:05 +0530 Medecins Sans Frontieres (MSF) supports the 'patent opposition' just filed at India's Patent Office by the Initiative for Medicines, Access and Knowledge (I-MAK), which aims to prevent the US pharmaceutical company Gilead/Pharmasset from gaining a patent in India. Patent on sofosbuvir, a drug for hepatitis C that is coming to market soon with an anticipated exorbitant price. Gilead is expected to charge around $80,000 for one treatment course of sofosbuvir in the US.Even if offered at a fraction of this price in developing countries, this drug will be priced out of reach. The patent opposition-a form of citizen review allowed in many countries-offers technical grounds to show a drug does not merit patenting under India's Patents Act. This opposition was filed to ensure that affordable generic versions of sofocbuvir can be produced to help the millions of people infected with chronic hepatitis C in developing countries access the drug. "Old science, known compound," said Tahir Amin, lawyer and director of I-MAK.org. "India's patent law doesn't give monopolies for old science or for compounds that are already in the public domain. We believe this patent on sofosbuvir does not deserve to be granted in India and have the legal grounds to prove it." Sofosbuvir is the first of several oral hepatitis C drugs expected to come to market in the coming year. It cures hepatitis C in a much shorter time period than today's available treatment, and for some forms of hepatitis C, eliminates the need to use the injectable drug pegylated interferon, which can be difficult to administer and causes many serious side effects. Gilead is anticipated to receive marketing approval for sofosbuvir in the US on 8 December. MSF has started providing hepatitis C treatment for a small number of people co-infected with HIV in its clinic in Mumbai, but cost (as high as $5,000 per patient) and complexity of today's available treatment means that patient numbers remain extremely low despite considerable needs. ]]> <![CDATA[World's first Lung Cancer drug launched in India]]> https://biospectrumindia.com/news/95/5172/worlds-first-lung-cancer-drug-launched-in-india.html https://biospectrumindia.com/news/95/5172/worlds-first-lung-cancer-drug-launched-in-india.html Thu, 21 Nov 2013 18:36:00 +0530 According to WHO, approximately 1.25 million people are diagnosed with Lung Cancer every year globally, and around 30% of them suffer from squamous NSCLC. Dr T Ramasami, Secretary to the Government of India, Department of Science and Technology commented, "Lung cancer is a major killer among all cancers. In this scenario, Mycidac-C is a new hope for patients suffering form lung cancer, particularly for Indian patients." This new drug is a first-in-class active immunotherapy, as well as a drug targeting Desmocollin-3. According to Cadila, there has been no significant innovation in the management of squamous NSCLC ever since the introduction of platinum containing doublet in 1983. However, Mycidac-C has to be used with platinum containing doublet therapy. Speaking at the launch, Dr Rajiv I Modi, Chairman and Managing Director, Cadila Pharmaceuticals, said, "It has taken us over a decade, a huge investment and a dedicated research and development team to develop this unique drug." Mr Modi further added, "We expect it to be available in the Indian market by December 2013. Thereafter, we will introduce it in other regions like SAARC countries and European markets over the next five years." Besides affordability, Mycidac-C has no systemic side effects during the treatment said the press release on Thursday. ]]> <![CDATA[A night to honor Bioscience honchos: The countdown begins for the 11th Annual BioSpectrum Awards]]> https://biospectrumindia.com/news/95/3384/a-night-to-honor-bioscience-honchos-the-countdown-begins-for-the-11th-annual-biospectrum-awards.html https://biospectrumindia.com/news/95/3384/a-night-to-honor-bioscience-honchos-the-countdown-begins-for-the-11th-annual-biospectrum-awards.html Thu, 21 Nov 2013 16:52:00 +0530 ]]> <![CDATA[UNAIDS Report: HIV infections in India register significant decrease]]> https://biospectrumindia.com/news/95/3509/unaids-report-hiv-infections-in-india-register-significant-decrease.html https://biospectrumindia.com/news/95/3509/unaids-report-hiv-infections-in-india-register-significant-decrease.html Thu, 21 Nov 2013 12:50:07 +0530 The UNAIDS report has appreciated India for bringing down the number of newly infected adults between 2000 and 2009. It comes as a major boost for the researchers, government, healthcare workers and those who are vulnerable to it. "With 80 per cent of these drugs being generics purchased in India, several billion dollars have been saved over the past five years. The country is also committed to new forms of partnership with low-income countries through innovative support mechanisms and South South cooperation," the UNAIDS report says. It also points out that India already provides substantial support to neighbouring countries and other Asian countries - in 2011, it allocated USD 430 million to 68 projects in Bhutan across key socio-economic sectors, including health, education and capacity-building. In 2011 at Addis Ababa, the Government of India further committed to accelerating technology transfer between its pharmaceutical sector and African manufacturers Though rate of HIV transmission in Asia is slowing down, atleast 1,000 new infections among adults continue to be reported in the continent every day in 2011. An estimated 3,60,000 adults were newly infected with HIV in Asia in 2011, considerably fewer than 4,40,000 estimated for 2001, report has said. At the same time, it has mentioned that some smaller countries in Asia like Afghanistan and Philippines are experiencing increases in the number of people acquiring HIV infection. It said a total 17 lakh people had died across the world due to AIDS related illness. In India, the figure for such deaths stood at 1.7 lakh in 2009. ]]> <![CDATA[Father of modern genomics passes away]]> https://biospectrumindia.com/news/95/7249/father-of-modern-genomics-passes-away.html https://biospectrumindia.com/news/95/7249/father-of-modern-genomics-passes-away.html Thu, 21 Nov 2013 10:45:00 +0530 His death was confirmed yesterday by the MRC Laboratory of Molecular Biology, which Dr Sanger found in 1962. Speaking to BioSpectrum India on Dr Sanger's sad demise, Dr Lalji Singh, vice-chancellor, Banaras Hindu University, Varanasi, said, "The news of Fred Sanger's passing away comes with a sense of shock and grief. Though in mid-nineties, Prof Sanger was still active and in the vanguard of contemporary molecular biology." Dr Sanger is considered as the "father of genomics" after his pioneering work on exact sequencing of the building blocks of DNA. He also developed techniques to determine the structure of proteins. Condoling Dr Sanger's demise, Dr Ch Mohan Rao, director, Centre for Cellular & Molecular Biology (CCMB), Hyderabad, expressed to BioSpectrum India that Dr Sanger was a brilliant scientist and that his contributions were critical for the initiation and growth of two major current research activities - Genomics and Proteomics. He added, "Dr Sanger developed methods to sequence both proteins and nucleic acids which made major differences for the progress of research in biological sciences. Most of our research activity begins with or culminates with sequencing of biopolymers which he developed. CCMB condoles the death of a great scientist." Dr Frederick Sanger was born in 1918 in Gloucestershire (UK) and had initially planned to pursue medicine following in his father's foot steps. However, he majored in biochemistry at the University of Cambridge, only to become the 'Father of Modern Genomics'. Dr Singh also said that Dr Sanger's efforts were directed towards developing techniques in sequencing DNA. "Sequencing of genomes has given rise to diverse new areas of genomic biology whose credit, quite substantially, would rightfully go to Sanger. Unlike most other scientists whose time at the bench reduces with age, Sanger remained an active worker right up to his last years. We deeply mourn his sad demise," he said. Currently, Dr Sanger is the only Briton to win two Nobel Prizes, and both of the prizes were awarded for his groundbreaking work in Chemistry. Dr Sanger won his first Nobel Prize in chemistry, in 1958, for showing how amino acids link together to form insulin. In 1980, he received his second Nobel Prize, which was also in chemistry, for inventing a technique to read the molecular letters that make up the genetic code. Immersed in pursuit of exploration, with single-minded determination, intellectual prowess, precision and imagination, and uncommon sense of humility, Dr Frederick Sanger is said to be a quintessential scientist, who left an indelible imprint on the sand of time. ]]> <![CDATA[Venus becomes first Indian pharma firm to get marketing approval for meropenem in Gulf]]> https://biospectrumindia.com/news/95/4044/venus-becomes-first-indian-pharma-firm-to-get-marketing-approval-for-meropenem-in-gulf.html https://biospectrumindia.com/news/95/4044/venus-becomes-first-indian-pharma-firm-to-get-marketing-approval-for-meropenem-in-gulf.html Wed, 20 Nov 2013 15:15:09 +0530 Venus Remedies, a research-based global pharmaceutical firm, has emerged as the first Indian company to get approval for meropenem in the Gulf with marketing authorisation from the Saudi Food and Drug Authority (SFDA). The company is planning to launch this product in Saudi Arabia, considered one of the most lucrative pharmaceutical markets in the world, early next year. Lauding the achievement, Venus Remedies, chairman and managing director, Mr Pawan Chaudhary said, "Venus has become the first generic drug manufacturer in the world to get marketing approval for this product from the Gulf Cooperation Council (GCC). The $35-million market for meropenem in Saudi Arabia offers a huge opportunity to us, and we are aiming at capturing a 25% share in this market within the first year of the launch itself. Securing marketing authorisation from Saudi Arabia for meropenem is a significant and prestigious achievement for the company as the Saudi Arabian market is known across the world for its stringent quality control. This achievement is a hallmark of our regulatory team's competence. Their hard work has been duly rewarded." Meropenem is an off-patented antibacterial agent of the carbapenem class of antibiotics, which caters to diseases with a broad range of serious infections caused by single or multiple susceptible bacteria in both adults and children. Since Saudi Arabia relies substantially on imports for pharmaceutical products due to insufficient domestic production and lack of indigenous research capabilities to meet the local demands, this marketing authorisation offers a great opportunity to Venus to capture a fair share in the meropenem market in all the GCC markets, including Saudi Arabia. With the SFDA being a major reference authority for regulatory standards and compliance and Venus Remedies emerging as the first and only generics manufacturer for meropenem in Saudi Arabia, apart from AstraZeneca, an innovator pharmaceutical company, Venus enjoys a competitive edge in getting marketing approval for meropenem from all GCC member nations and Middle East countries. With growing population, pharmaceutical sales in Saudi Arabia, which stood at US $4 billion in 2012, are expected to surpass US $7 billion by 2018. As evident from this, Saudi Arabia is set to emerge as one of the world's fastest growing markets in years to come. Said Ashutosh Jain, Executive Director, Venus Remedies and CEO, Venus Pharma GmbH, "The regulatory requirements of Saudi Arabia are very stringent and expensive, due to which other generic pharmaceutical companies are unable to get the product registrations even after constant efforts. We are proud of our drug regulatory capabilities, which have enabled us to register the first generic formulation of meropenem injection in Saudi Arabia." The overall GCC pharmaceutical market is worth more than US $8 billion, and it is growing enormously at a compound annual growth rate (CAGR) of 8%. The Saudi pharmaceutical market is the largest in the GCC, accounting for more than 50% of all the GCC markets put together. This offers tremendous opportunities to Venus Remedies to enter both the private and public segments of this market. At present, Venus is selling meropenem in various markets, including the European Union, and is in the process of extending its footprint and sales operations in regulated countries like Australia, Spain, Switzerland, South Africa and a few more. The company has already received marketing authorisation for meropenem from the UK (MHRA), France, Austria, Denmark, Finland, Ireland, Germany, Netherlands, Poland, Slovenia, Slovakia, Sweden, Portugal, Czech Republic, Cyprus, New Zealand and Mexico. Its product has also made its way to the Balkan countries with marketing approvals from Bosnia & Herzegovina and Croatia. ]]> <![CDATA[ICAR joins hands with ABLE to increase its global presence]]> https://biospectrumindia.com/news/95/3505/icar-joins-hands-with-able-to-increase-its-global-presence.html https://biospectrumindia.com/news/95/3505/icar-joins-hands-with-able-to-increase-its-global-presence.html Wed, 20 Nov 2013 15:01:29 +0530 ICAR and ABLE signed a memorandum of understanding (MoU) for knowledge partnership at New Delhi on November 18, 2013 at New Delhi.. The objective of this MoU is to facilitate effective and efficient communication and promotion of ICAR's mandate, achievements and capabilities in the international arena to position ICAR as an important stakeholder and enabler in addressing global issues in the areas of food production, biofuels, impact of climate change on agriculture and resource conservation. ABLE is a national forum that represents the Indian Biotechnology Sector is to accelerate the pace of growth of the Biotechnology Industry in India through encouraging greater investment in the sector, providing a platform for domestic and overseas organizations to explore collaborations and partnerships with the government of India in their endeavors and forging stronger linkages between academia and industry. Dr S Ayyappan, secretary DARE and Director General, ICAR and Dr. Anil Chauhan, Director, ABLE signed the MoU. Mr Arvind Kaushal, additional secretary, DARE and secretary, ICAR and Dr Rameshwar Singh, project director, Directorate of Knowledge Management in Agriculture (DKMA), ICAR were also present on the occasion. ]]> <![CDATA[Avesthagen Pharma signs pact with Elpen Pharmaceuticals]]> https://biospectrumindia.com/news/95/4022/avesthagen-pharma-signs-pact-with-elpen-pharmaceuticals.html https://biospectrumindia.com/news/95/4022/avesthagen-pharma-signs-pact-with-elpen-pharmaceuticals.html Wed, 20 Nov 2013 13:32:00 +0530 AVDESP is a biosimilar for Darbepoetin alfa Aranesp, which is used for treating anaemia resulting from chronic kidney disorders and cancer chemotherapy. According to the company's press release, as per the agreement, the distribution will happen in the following countries, namely, Greece, Cyprus, Bulgaria, Romania, Croatia, Slovenia, Slovakia, Serbia, Bosnia, Former Yugoslav Republic of Macedonia (FYROM), Albania, Montenegro and Kosovo, with a collective population base of over 70 million. "We are excited about this alliance as we start our marketing in some of the most interesting countries, which will give us an opportunity to know these markets and interact with its people. The company is committed to deliver affordable healthcare for humanity," said Dr Villoo Morawala Patell, chairperson, APAG. APAG is currently engaged with many other opportunities for a number of its 'biosimilars' and 'biobetters'. APAG is working with different outsourcing organizations to bring out products to the market. So far it has identified Syngene International for fill and finish, and Kemwell Biopharma as a CMO (Contract Manufacturing Organization), and PRA International to conduct Phase I clinical trials in the Netherlands, followed by phase III in India. ]]> <![CDATA[Arvind Remedies develops new antiviral drug]]> https://biospectrumindia.com/news/95/6398/arvind-remedies-develops-new-antiviral-drug.html https://biospectrumindia.com/news/95/6398/arvind-remedies-develops-new-antiviral-drug.html Mon, 18 Nov 2013 19:09:00 +0530 According to the company's press release, ARL has completed the preclinical studies of the drug and it is now ready for clinical evaluation. The company now seeks to formulate a drug which will have higher bio-availability, higher efficacy and minimum side effects for treatment of viruses like Human Herpes virus, Varivella zoster virus, Chickenguniya and Chicken Pox. Dr B Arvind Shah, MD and CEO, Arvind Remedies, said, "After three years of extensive research with the combined efforts of our R&D team and various other renowned institutes under the MoU, we are happy to announce our success in completing the preclinical studies of the antiviral agent that can fight diseases like Human Herpes, Chickenguniya and Chicken Pox." "We have filed the patent for this drug and our next step is to undertake clinical studies as per global regulatory requirements," he further added. According to Prof Rajarajan, Principal Investigator of the Project, said, "The isolated drug from botanical source has been proved to be an effective antiviral drug and is also safe both in in-vitro and in-vivo models." Earlier in 2010, Arvind Remedies entered into an MoU with the Department of Science & Technology, Government of India, Presidency College, Department of Biotechnology, Tamil Nadu Veterinary & Animal Sciences University and Indian Institute of Integrative Medicines, Jammu, to undertake research for the development of antiviral agent from a compound isolated from botanical source and now the successful completion of the preclinical research would open new avenues towards growth moving forward. ]]> <![CDATA[ Fight against Antibiotic Resistance: Cadila Pharmaceuticals signs deal with Helperby Therapeutics]]> https://biospectrumindia.com/news/95/8404/-fight-against-antibiotic-resistance-cadila-pharmaceuticals-signs-deal-with-helperby-therapeutics.html https://biospectrumindia.com/news/95/8404/-fight-against-antibiotic-resistance-cadila-pharmaceuticals-signs-deal-with-helperby-therapeutics.html Mon, 18 Nov 2013 18:14:21 +0530 This announcement is seen as a major breakthrough in the fight against resistance with the discovery of patented 'resistance breaker' compounds. These new compounds are termed as Antibiotic Resistance Breakers. When an Antibiotic Resistance Breaker is combined with an old obsolete antibiotic, it can rejuvenate it and make it active against highly resistant bacteria. Antibiotic Resistance Breakers can potentially rescue several different classes of antibiotics. Furthermore, this approach requires the development of fewer novel compounds, is less risky and less costly than the traditional "one antibiotic" route. Speaking on the occasion, Cadila Pharmaceutical's CMD, Dr Rajiv I Modi, said, "The founder chairman of our company, Shri I A Modi, believed in providing affordable medicines for the masses through innovative and cutting-edge research & development (R&D). This discovery will open new avenues against resistant organisms and is very timely in view of global concerns about rapidly growing bacterial resistance against current antibiotics. Cadila Pharmaceutical's collaboration with Helperby can help the mankind win the battle against the microbes and hopefully save millions of lives in coming years." Travelling with the UK's Trade Delegation to India, led by Prime Minister David Cameron, Helperby signed its first major licensing deal with Cadila Pharmaceuticals to take the compound through further clinical trials, approvals and into commercialization. Helperby will supply Cadila Pharmaceuticals with Antibiotic Resistance Breakers, while Cadila Pharmaceuticals will develop the combinations with old antibiotics. Helperby's chief scientific officer, Prof Anthony Coates commented, "The emergence and spread of drug-resistant pathogens has accelerated, while the pipeline for new anti-microbial drugs has all but run dry - this exciting and timely partnership with Cadila Pharmaceuticals offers us all hope." ]]> <![CDATA[Nod to GM can make Agri-biotech sector worth $ 40 billion says K M Shaw]]> https://biospectrumindia.com/news/95/3798/nod-to-gm-can-make-agri-biotech-sector-worth-40-billion-says-k-m-shaw.html https://biospectrumindia.com/news/95/3798/nod-to-gm-can-make-agri-biotech-sector-worth-40-billion-says-k-m-shaw.html Mon, 18 Nov 2013 17:29:00 +0530 Speaking on the sidelines of the third convocation and fifth annual lecture of NIIT University in Rajasthan, Dr Kiran Mazumdar Shaw has expressed hope that the Indian biotechnology is a USD 100 billion sector by 2025. I really believe this can be done if we have right policies in place, right resources and right investments," said. Asking the government to allow the genetically modified crops and formulate enabling policies, she mentioned that without that the country cannot be food sufficient. "Agri bio can itself provide a USD 40 billion sector, Already BT Cotton is a USD 7.5 billion sector for the country. If you allow other genetically modified crops it could be much bigger," Shaw said. Stressing on that fact that technology is important to make a farmers prosperous, Kiran also mentioned, "Moreover this would also lead to less use of pesticides which are very harmful. You need to reduce pests and pesticides and that can only be done with technology." ]]> <![CDATA[ Growth in Analytical Instruments Industry brings a new momentum to all industrial segments]]> https://biospectrumindia.com/news/95/6571/-growth-in-analytical-instruments-industry-brings-a-new-momentum-to-all-industrial-segments.html https://biospectrumindia.com/news/95/6571/-growth-in-analytical-instruments-industry-brings-a-new-momentum-to-all-industrial-segments.html Mon, 18 Nov 2013 17:00:56 +0530 The seventh edition of analytica Anacon India 2013 jointly organized by Messe Munchen International (MMI) and Indian Analytical Instruments Association (IAIA), commenced with an unprecedented number of industry professionals presence. The event addressed the challenges as well as the opportunities in the Rs 5,500 crore analytical instruments industry. The event was inaugurated by Dr Niloufer Shroff, scientist 'G' & HOD, EMCD & Photonics Cell, Deity, Government of India; Mr Michael Siebert, Honourable Consul General of the Federal Republic of Germany; Mr KV Venugopalan, President, (IAIA); Prof. Dr Oliver Schimtz, University Duisburg-Essen, Department of Applied Analytical Chemistry and Dr. Martin Lechner, Director of Business Unit New Technology, Munich Trade Fairs International. Speaking on the contribution of Indian analytical industry to the overall growth of the economy, Mr. K V Venugopalan, president, Indian Analytical Instruments Association, said, "The Indian Analytical instrument market including consumables and spares is estimated at around $1 billion with a growth rate of above 10 percent. This along with the rising demand and developments in food safety and pharmaceuticals production will help the industry grow at a steady pace. There is high dependence on import of technologies for research and at times they are not easily available for various commercial or legal reasons. The time has come to focus on developing cutting edge technologies and instruments in India that will give us advantage in the coming decades." analytica Anacon India attracted visitors from various domains like, Pharmaceutical, Health care, Food, Medical Laboratory, Medicine, Universities and Research Institutes. This edition of the event witnessed an impressive line-up of 113 exhibitors from the instrumentation industry, like Waters India, Agilent technologies, Bruker AXS Analytical instruments Pvt Ltd, Metrohm India Ltd., GCE India Pvt Ltd., S.V Scientific, Marsap and so on. The event also had international country pavilions from China and Japan. The event was spiced by extensive conference programs, is one-of-its-kind platform for exchange of knowledge and ideas in this niche sector. Addressing various concerns in instrumentation industry, the analytica Anacon India Conference with the topic "Research & Regulations: Challenges for the Pharmaceutical, Life Science and Food Industries" was presided by industry leaders as well as international speakers from the science, giving expert insights into the latest research developments in the analysis, chromatography, biotechnology and life-science sectors. The program was organized by IAIA and Prof. Dr Oliver Schmitz (University Duisburg-Essen, dept. Applied Analytical Chemistry) ]]> <![CDATA[Plant genetic resource conservation gets attention ]]> https://biospectrumindia.com/news/95/6212/plant-genetic-resource-conservation-gets-attention-.html https://biospectrumindia.com/news/95/6212/plant-genetic-resource-conservation-gets-attention-.html Mon, 18 Nov 2013 16:39:33 +0530 The International Training Course is being organized by the National Bureau of Plant Genetic Resources (NBPGR) - Bioversity International Centre of Excellence. The 2013 training course 'In vitro and cryopreservation for conservation of plant genetic resources: Current methods and techniques' is being co-organized with the Asia-Pacific Consortium on Agricultural Biotechnology (APCoAB), a programme of Asia-Pacific Association of Agricultural Research Institutions (APAARI). The course will be conducted from November 26 to December 07, 2013 at NBPGR, IARI Campus, New Delhi, India. NBPGR is one of the leading institutes under the Indian Council of Agricultural Research (ICAR), New Delhi, India for plant genetic resources (PGR) management. This practical, hands-on course is designed for those currently involved in the development and use of in vitro and/or cryopreservation techniques for the medium- to long-term conservation of vegetatively propagated and non-orthodox seed species. The course aims to improve skills of participants in using tissue culture techniques for conservation and management of PGR; equip participants with essential knowledge necessary for developing and using cryopreservation techniques; enhance the use of in vitro conservation and cryopreservation protocols for germplasm of crops relevant in their countries. The course will also acquaint the participants with molecular techniques for PGR managementand make them understand the underlying principles of stress tolerance during processing for conservation. ]]> <![CDATA[CSIR scientist bags Infosys Prize 2013 ]]> https://biospectrumindia.com/news/95/4166/csir-scientist-bags-infosys-prize-2013-.html https://biospectrumindia.com/news/95/4166/csir-scientist-bags-infosys-prize-2013-.html Mon, 18 Nov 2013 15:51:30 +0530 The Infosys Prize 2013 Life Sciences is awarded to Dr Rajesh S. Gokhale, director, CSIR-Institute of Genomics and Integrative Biology, for his work in the field of lipid metabolism in tubercle bacilli. Each year two million people are infected and die of tuberculosis (TB) and there will be 10 million new patients every year. Dr Gokhale discovered biochemical networks and new paradigms necessary for the synthesis of Mycobacterium tuberculosis (Mtb) cell envelope coat that makes these bacteria escape host immune systems. This discovery opens up new avenues to develop new therapy against TB. As per the announcement of Infosys Science Foundation the winners of the Infosys Prize 2013 for outstanding research contributions across six categories such as Engineering and Computer Science, Humanities, Life Sciences, Mathematics, Physical Sciences, and Social Sciences. Last year, Dr Ashish Lele, CSIR- National chemical Laboratory (CSIR-NCL), Pune and Dr. Ayyappanpillai Ajayaghosh, CSIR- National Institute for Interdisciplinary Science and Technology (CSIr-NIISt), Thiruvanathapuram were among the winners of the Infosys Prize 2012, in the categories of Engineering and Computer Sciences and Physical Sciences respectively. Earlier, Dr. Imran Siddiqi, a scientist from CSIR- Centre for Cellular and Molecular Biology (CSIR-CCMB), Hyderabad, was honored with Infosys Prize 2011 in the category of life Sciences. Prof Samir K Brahmachari, DG,CSIR, said that this prestigious award to four CSIR scientists in consecutive three years after the inception of the award in 2009 exhibit that internationally competitive scientific research is being carried out in CSIR and CSIR has an outstanding young scientific leadership in position. ]]> <![CDATA[DHR short term course on proteomics]]> https://biospectrumindia.com/news/95/5991/dhr-short-term-course-on-proteomics.html https://biospectrumindia.com/news/95/5991/dhr-short-term-course-on-proteomics.html Fri, 15 Nov 2013 16:33:01 +0530 The course promoted by the ministry of health and family welfare, is targeted at faculty from medical colleges who are interested in the applications of proteomics for medical and nutrition research. With only five seat available, the course is being held at Jamia Osmania, Hyderabad. The selected candidates will be provided travelling allowance, food and accommodation on campus as per government of India norm. The last date of submission of applications is December 09, 2013. ]]> <![CDATA[GSK invests Rs 864 crore for its new facility in India]]> https://biospectrumindia.com/news/95/7473/gsk-invests-rs-864-crore-for-its-new-facility-in-india.html https://biospectrumindia.com/news/95/7473/gsk-invests-rs-864-crore-for-its-new-facility-in-india.html Fri, 15 Nov 2013 12:19:00 +0530 Talking about the investment, Sir Andrew Philip Witty, CEO, GSK, said, "GSK is a long-standing investor in India and we fully support the government in their efforts to increase access to affordable medicines and to improve healthcare. This new facility will substantially increase the capacity of our manufacturing base and enable us to bring more medicines to the people of India." Mr Witty, who was on a visit to India yesterday, further added that, "The location of the new factory hasn't been finalized, however, the lead site will be in Bangalore." In this regard, GSK is expected to partner with local design and construction companies to build its state-of-the-art manufacturing facility. When complete, the new facility will make pharmaceutical products for the Indian market at the rate of up to eight billion tablets, and one billion capsules a year, said the company's press release. The facility is expected to be operational by 2017, which will include a warehouse, site infrastructure and utilities to support the manufacturing and packing of the medicines. Also, the new plant is expected to create about 250 new jobs. The company claimed that it has invested over Rs 1017 crore [£ 100million] in the last decade and is proactively seeking to build capacity in India, as it delivers its portfolio of products in areas such as gastroenterology and anti-inflammatory medicines. ]]> <![CDATA[ Venus Remedies set to tap Italian market with meropenem]]> https://biospectrumindia.com/news/95/4216/-venus-remedies-set-to-tap-italian-market-with-meropenem.html https://biospectrumindia.com/news/95/4216/-venus-remedies-set-to-tap-italian-market-with-meropenem.html Thu, 14 Nov 2013 17:24:31 +0530 Venus Remedies, one of India's fastest growing research-based pharmaceutical companies, has received marketing authorisation from Italy for its generic broad-spectrum antibiotic injectable, "meropenem", via the decentralised procedure (DCP) route. The company is planning to launch this product in Italy next year. Hailing the achievement, Dheeraj Aggarwal, Chief Financial Officer, Venus Remedies, said, "The total meropenem sales in Italy stood at about Euro 50 million in 2012, and Venus Remedies is confident of bagging a 10% share in this market. Being an important member state of the European Union (EU), Italy has immense potential for meropenem. This marketing authorisation offers a huge opportunity to Venus Remedies to expand its export base across the globe." Meropenem is an off-patented antibacterial agent of the carbapenem class of antibiotics, which caters to diseases with a broad range of serious infections caused by single or multiple susceptible bacteria in both adults and children. Venus Remedies is generating handsome revenue from the exports of meropenem to EU markets. Last year, the company generated a business of around Euro 5 million from meropenem exports. This figure is expected to double by the end of this year. Venus Remedies, along with its business partners, is offering the best-quality meropenem to 35 countries. It is aiming to penetrate the meropenem markets of another 15 countries by the first quarter of 2014. The company has already received marketing authorisation for meropenem from the UK (MHRA), France, Austria, Denmark, Finland, Ireland, Germany, Netherlands, Poland, Slovenia, Slovakia, Sweden, Portugal, Czech Republic, Cyprus, New Zealand and Mexico. Its product has also made its way to the Balkan countries with marketing approvals from Bosnia & Herzegovina and Croatia. ]]> <![CDATA[Confederation of Indian Industry (CII) and Municipal Corporation of Greater Mumbai (MCGM) join hands to fight Diabetes]]> https://biospectrumindia.com/news/95/8396/confederation-of-indian-industry-cii-and-municipal-corporation-of-greater-mumbai-mcgm-join-hands-to-fight-diabetes.html https://biospectrumindia.com/news/95/8396/confederation-of-indian-industry-cii-and-municipal-corporation-of-greater-mumbai-mcgm-join-hands-to-fight-diabetes.html Wed, 13 Nov 2013 13:46:04 +0530 With the aim to raise awareness for the growing incidence of Diabetes, Confederation of Indian Industry (CII) and Municipal Corporation of Greater Mumbai (MCGM) launched a 'Drive against Diabetes campaign in a unique public private partnership mode to mobilize people to join the fight against diabetes, this World Diabetes Day. Mr Sunil Prabhu, Mayor of Mumbai, inaugurated the noble social initiative today at Mumbai.CII in a novel partnership with the MCGM will mobilize Mumbaikars to screen themselves for Diabetes on 13th November in conjunction with the world diabetes day. Corporates like Apollo hospitals, Apollo Munich, OneTouch, Abbott, SANOFI and several others have come forward to support this unique Public Private Partnership Model in initiating the drive against Diabetes. Such an initiative promises both scale and sustainability in the efforts to combat this silent disease. Speaking on the occasion, Mr. Sunil Prabhu, Mayor of Mumbai, expressed concern on the steady rise of the incidence of the diabetes, "Today diabetes is one of the major conditions affecting people's health and lifestyle, it is estimated that by 2030 the diabetic population will be around 10 crores. Out of which 6.2% are expected to be suffering from diabetes and 15% from blood pressure. Within India, Mumbai is leading this race to the top - the city experiences a hectic work culture, high levels of stress and fewer sleeping hours. During tomorrow's drive we expect that even if 10000-12000 people are tested positive for diabetes, we will incorporate that in the MCGM's database and an SMS alert will be sent to them after three months suggesting next level of detailed diagnostics. the testing of 200000 people in a single drive is a record in itself but I will be happy if 500000people are tested in the next drive and fewer are diagnosed positive for diabetes." Ms Manisha Patankar - Mhaiskar, IAS Additional Municipal Commissioner (Western Suburbs) MCGM said, "MCGN started its drive against diabetes in 2011, under which 21700 people were diagnosed with diabetes at the dispensary level. Around 25645 and 34782 were diagnosed positive at MCGM run hospitals and major public hospitals in Mumbai. Currently there are more than 86000 patients on the MCGM diabetes database, out of these 15% who are at the initial stage are being suggested lifestyle modifications and 61% and 22% detected with controlled and uncontrolled diabetes respectively under the MCGM medical care program. But the ambition is to create awareness of diabetes and not to focus on numbers."Ms Shobana Kamineni, Chairperson CII National Committee on Public Health and executive, Apollo Hospitals Enterprise Limited in her address mentioned; "Diabetes is a silent killer as there are no symptoms, hence it becomes important for each one of us to get checked. We will ensure that Mumbaikars are made aware of healthy dietary habits and easy to adopt lifestyle changes." The nature of this unique PPP involves the partners setting up over 500 screening centers on 13th November across MCGM across its ward offices, over 40 member companies of CII (Reliance, Larsen and Turbo, ICICI, Star Indian. Mahindra, Bajaj, Blue dart and many more), chemists, pharmacists and public places in Mumbai that will target to screen over 200,000 individuals reaching out to the workforce as well as the larger community. ]]> <![CDATA[India declared free from bird flu ]]> https://biospectrumindia.com/news/95/5198/india-declared-free-from-bird-flu-.html https://biospectrumindia.com/news/95/5198/india-declared-free-from-bird-flu-.html Wed, 13 Nov 2013 12:00:31 +0530 On August 05, 2013, India notified outbreak of Avian Influenza (H5N1) at Poultry Production Unit, College of Veterinary Sciences and Animal Husbandry, Anjora, Durg and Government Poultry Farm, Jagdalpur, Chhattisgarh. The control measures adopted in the outbreak were stamping out of entire poultry population including destruction of eggs, feed, litters and other infected materials in the radius of 1 kilometer around the outbreak location, restriction on movement of poultry, disinfection and cleaning up of infected premises and subsequently issuing of the Post Operation Surveillance Plan (POSP). The POSP was issued on August 12, 2013. Even though India is free from bird flu, regular surveillance to be continued throughout the country especially in the vulnerable areas bordering infected countries and in areas visited by migratory birds. ]]> <![CDATA[Sanofi partners with PVR Nest for 'Healthy Children, happy children' initiative]]> https://biospectrumindia.com/news/95/8432/sanofi-partners-with-pvr-nest-for-healthy-children-happy-children-initiative.html https://biospectrumindia.com/news/95/8432/sanofi-partners-with-pvr-nest-for-healthy-children-happy-children-initiative.html Tue, 12 Nov 2013 17:44:00 +0530 As the Country prepares to celebrate Children's Day, Sanofi India Limited joined hands with PVR Nest (the social program and registered foundation of India's largest film entertainment company PVR Limited) for its 'Healthy children, happy children' initiative to launch India's largest student-led campaign on children's health. The largest in its outreach and scope so far, the program titled CineArt 'Healthy children, happy children' will bring together leading Indian pediatricians, with NGOs and artists in the field of creative learning, to mentor 2,00,000 school children from 200 schools (an equal mix between Public/Privately held schools and NGO/ Community schools) in 4 cities-Chennai, Delhi, Hyderabad and Mumbai, on critical aspects of children's health. Speaking at the launch event in Delhi, Joanna Potts, commercial operations officer - Sanofi India stated, "Over the years, Sanofi has provided medication and healthcare tools to address numerous fundamental childhood health issues, from routine to life-threatening. Through our new 'Healthy children, happy children' initiative, we aim to diversify and adapt our healthcare offer to young Indian patients, with innovative products, services and awareness initiatives. We are delighted to partner with PVR Nest for a first-of-its-kind interface between pediatricians, NGOs and artistes for this innovative, year-long school awareness program on health. We are looking forward to seeing children-in-action during the school health workshops, and also, during the making of original 'Healthy children, happy children' health films and publication." Six hundred health workshops using experiential learning methodologies like puppetry, theatre, storytelling and capacity building exercises, will be tapped to sensitize children on relevant health topics like hygiene, environment, play and exercise, disability and discrimination, vaccination, ergonomics, among others. Talking about this initiative, Mr. Renaud Palliere, CEO- International Business, PVR said "At PVR Nest, we are continuously looking at addressing core issues that affect the communities that we live in and thus uphold our commitment towards urban sustainability. We are extremely happy to partner with Sanofi India to create education and action on the very important issue of children's health. We look forward to developing a sustained partnership with India's leading pediatricians, schools and experts who are participating in this program. As a film exhibition company, we will provide the best possible outreach to the original films the students will make during this campaign, through our presence in 37 cities country wide". One of the significant outcomes of this year-long creative and collaborative educational program on child health will be the formation of around 200 'Healthy children, happy children' School Clubs. The clubs will have an outreach within schools, as well as to parents and communities outside, to sustain health education and awareness. Another key achievement of the program is the film making process wherein eminent film makers will be training selected students from shortlisted schools, to make original health films. These would be proudly screened by PVR cinemas across the country to reach millions of movie goers with key messages on children's health.The launch event at Delhi was attended by leading Delhi pediatricians, school founders & students of the 50 participating schools, and graced by Dr Syeda Hameed, Member, Planning Commission, Government of India, as the Chief Guest. Special Guests and speakers also included Dr. Rajeev Seth, President, Indian Academy of Pediatrics Delhi, and eminent theatre actor, Shivani Wazir Pasrich. The program opened with an original children's theatre production on health, and also saw the launch of a special campaign film featuring children, to drive home the message of health. About Sanofi and PVR Nest's CineArt Healthy children, happy children initiative:â€¢School outreach program in Chennai, Delhi, Hyderabad and Mumbai to mentor 2,00,000 childrenâ€¢ Outreach to an equal mix of Public/Privately held schools and NGO/ Community schoolsâ€¢Six hundred creative knowledge sessions and health workshops â€¢ Formation of 200 'Healthy children, happy children' health clubsâ€¢ Students to share key-learnings in creative formats such as posters, drawings, skits and plays â€¢ The best creative entries to feature in the first ever original children's publication on Health·Eight winning school teams (chosen on the basis of creative entries) to be trained on film making by eminent film makers; children to make films on chosen health themes·Further to the Grand finale, three 'best' health films will be screened at 100 PVR Cinema Screens across India for six months ]]> <![CDATA[GM is a key part of technological intervention for food governance, agree experts]]> https://biospectrumindia.com/news/95/8393/gm-is-a-key-part-of-technological-intervention-for-food-governance-agree-experts.html https://biospectrumindia.com/news/95/8393/gm-is-a-key-part-of-technological-intervention-for-food-governance-agree-experts.html Tue, 12 Nov 2013 16:57:00 +0530 While advanced technologies can provide much of the solutions for improved production and sustainability, the debate about use of such technologies to meet our future food requirements has reached a deadlock for long. Therefore, as a part of its initiative to provide a platform for dialogue and deliberation Governance Now magazine, organized the conference titled 'Future of food governance: role of technology for food security' in New Delhi on November 07, 2013. The event was aimed at triggering a discussion on issues like whether the country can produce enough food without any help from genetic engineering and can India forever ignore technology intervention in agriculture. The meeting was in the background of the fact that in all the debates over GM, there is common ground. And there is a common intent of both sides to have the food security for the future generation. Present on the occasion as the speacial guest was, Mr Dalip Singh, additional secretary, ministry of agriculture, government of India. The guest of honour was Dr R B Singh, president, NAAS. In his address, Dr R B Singh noted that GDP rate has slipped to 5% from 8-9% in the recent years. He expressed his dismay over the growing rigid gap between rich and poor. He commented further, "40% of the mal-nutritioned children are in India. Therefore, food bill has to reach out to poorest of poor." "The genetically modified (GM) technologies have been a point of different perspectives and debates. Different ministries hold divergent opinions on the issue. But the prime minister's opinion on the issue has been clear that liberation of science is important for the human society as the hunger of a child can't wait," said Dr Singh on the GM debate. Mr Dilip Singh agreed that there are various issues at multiple levels. However, he seemed to differ in the production of food grains as the primary issue. Elaborating further, he said, "The public distribution system is the main challenge at the moment. Another is the lack of crop diversification and capacity building for the government." Taking further on information and communication in agriculture, he stated further, "The use of ATMA, a model of extension for enabling proper agri technologies for ensuring food security, will help in the longer run." In his keynote address, Mr Tariq Anwar, minister of state for agriculture and food processing, was hopeful that soon the technologies beneficial for the country will get acceptance from all the sections of the society. "We are unable to derive full benefits of the technologies so far. Biotech is expected to play a great role in the crop improvement. This issue needs to be debated as the issue has been contentious across globe. Technical committee requires to be constituted in a proper way. Robust system required for scientific," said the minister. Anwar further admitted that there certainly are loopholes in the governance. "Something is seriously wrong with how the system operates," he said. Earlier Mr B V Rao, editor, Governance Now, in his speech welcomed the discussions and mentioned that all the stakeholders must repeatedly enter into dialogue with each other to resolve the issue in a amia This was followed by a panel discussion on 'Role of Technology in Food Security'. Among other panelists were Dr J S Sandhu, Agriculture Commissioner, Ministry of Agriculture; Dr S R Rao, Advisor, Department of Biotechnology, Govt of India; Mr. Sanjeev Gupta, Jt Secretary, Ministry of Agriculture, Govt of India; Prof Deepak Pental, Delhi University; Prof N Chandrashekhara Rao, Institute of Economic Growth; Mr Ajay Vir Jakhar, Chairman, Bharat Krishak Samaj. Few of the issues that were explored through discussions included India's agriculture challenges, food for future: sustainable options, role technology in food security, regulatory uncertainty and industry's concerns, germplasm exchanges and IPR, choices for the farmers and all others in food value chains, health and environment concerns and role of governance and decision making on all above issues. Dr N Seetharama, executive director, Association of Biotechnology Led Enterprises (ABLE-AG) in his thanking speech emphasized that the technology dissemination is very important. "GEAC issue requires to be sorted out as soon as possible as its defunct status is a major concern for whole agri-biotech sector." ]]> <![CDATA[Winners of Infosys Prize 2013 announced]]> https://biospectrumindia.com/news/95/3503/winners-of-infosys-prize-2013-announced.html https://biospectrumindia.com/news/95/3503/winners-of-infosys-prize-2013-announced.html Tue, 12 Nov 2013 16:48:00 +0530 The winners had been recognized for their outstanding achievements and contributions to scientific research. The Infosys Science Foundation also announced an increase in the prize money from Rs 50 lakh to Rs 55 lakh for each category for 2013. The prize for the humanities category will be split equally between the two winners. The seven winners had been chosen based on significant progress showcased in their respective spheres, as well as for the impact their research had had on their specific field. The winners of the Infosys Prize 2013 had been evaluated by a panel of jurors comprising of eminent scientists and professors from around the world. The jury chairs of the six categories are: Prof. Pradeep K. Khosla, engineering & computer science; Prof. Amartya Sen, humanities; Dr. Inder Verma, life sciences; Prof. Srinivasa S. R. Varadhan, mathematical sciences; Prof. Shrinivas Kulkarni, physical sciences; and Dr. Kaushik Basu, social sciences. ]]> <![CDATA[Pharma industry has improved itself over decades says Milkha Singh]]> https://biospectrumindia.com/news/95/7488/pharma-industry-has-improved-itself-over-decades-says-milkha-singh.html https://biospectrumindia.com/news/95/7488/pharma-industry-has-improved-itself-over-decades-says-milkha-singh.html Mon, 11 Nov 2013 17:59:00 +0530 The legendary athlete Milkha Singh on November 09, 2013, launched the Ranbaxy Diabetes Care at the annual conference of the Research Society for Study of Diabetes in India (RSSDI) held at Greater Noida in the National Capital Region. The initiative will provide continued access to affordable high quality generic diabetes medicines to patients across India. Speaking on the occasion, Milkha Singh said, "Physical fitness plays a vital role in fighting the adversities in life and give mental strength to bounce back. This is especially true for a disease like diabetes can be effectively managed through lifestyle modifications." Highlighting the importance of physical activity, Mr Singh shared his experience of life and personal views on how fitness can play an important role in overcoming hurdles in life, Mr Singh urged doctors to put on their running shoes and create awareness at the level of healthcare professionals which can be further translated to patients. Later during his interaction with the BioSpectrum, Mr Singh appreciated the efforts of Ranbaxy in launching this initiative. He also praised the government's efforts to focus on generic medicines. Talking about the pharma industry, he said, "The Indian pharma industry has improved its reputation over time and now we export into so many other nations. Asked about what he felt about rural areas still lagging behind, the running legend was hopeful that soon the healthcare will no longer be denied to rural folks. Elaborating Mr Singh said, "I have seen how rural India used to suffer decades back but now I feel positive when I see so much of innovation work happening." Speaking at the event, Rajeev Sibal, Vice President and Head-India Region. Ranbaxy Laboratories Ltd, "Today's hectic life style and socio economic changes have reduced the inclination and time for physical activity quite significantly leading to increased incidence of life style disorders like diabetes. Ranbaxy has launched a new team specifically for Diabetes called Ranbaxy Diabetes Care which is taking a lead for promoting physical activity and fitness amongst doctors and mass public as a first step toward tackling life style disorder like Diabetes." India has one of the highest numbers of people with diabetes in the world and the number is growing at an alarming rate. Diabetes is a metabolic disease in which a person has high blood sugar, either because the pancreas does not produce enough insulin, or because cells do not respond to the insulin that is produced. As per Dr Rajeev Chawla, Director, North Delhi Diabetes Centre and Organizing Secretary of RSSDI 2013, "India is facing a major challenge of diabetes and there is a constant need to keep abreast of latest developments in this field, so that we can be empowered to meet this challenge effectively. We doctors are the role models for the society hence exercise and fitness should start first from us." Around 4000 doctors participated at the RSSDI conference that saw prominent doctors from India and abroad to raise awareness about diabetes and share recent advances in treatment. ]]> <![CDATA[Alere India showcases latest range of Alere's hematology solutions]]> https://biospectrumindia.com/news/95/8048/alere-india-showcases-latest-range-of-aleres-hematology-solutions.html https://biospectrumindia.com/news/95/8048/alere-india-showcases-latest-range-of-aleres-hematology-solutions.html Mon, 11 Nov 2013 17:42:48 +0530 Medical experts from all over India, hematologists, pathologists, microbiologists, endocrinologists, diabetologists, cardiologists, general physicians and other medical experts, gathered at the 54th annual conference of Indian Society of Hematology and Blood Transfusion. Alere India, a subsidiary of the US-Based Alere Inc., a leading provider of near-patient diagnostics and health information solutions, launched its latest range of hematology solution, Alere h 560. Dr. M B Agarwal, country's leading hematologist launched Alere h 560 at the conference. The key feature of Alere h 560 is that it provides complete 5 part differential counts with 24 parameters and 2 scattergrams and 2 histograms. Compact, Ergonomically designed Alere h 560 caters to all the main requirements of the modern hematology laboratory. Alere has forayed into both the major segments of hematology machines, namely 3 PD and 5 PD analyzer. The Alere h 380 is a 3 part differential analyzer, which has very effective processing speed of 80 samples/hr and has been developed keeping in minds the requirements for start-up to middle workload labs. Alere h 560 or 5 part differential system will cater to the requirement of bigger labs and chains and has more reportable parameters and features. In India, diagnostic powerhouse Alere has been catering to the Infectious Disease Tests, Cardio-vascular range, toxicology/DOA range of products and women healthcare range and is now diversifying and entering into new segments as well. In India it is already representing Tosch for Immunoassay, Helena for electrophoresis and coagulation range. The company is now making a foray in hematology segment. This will enable Alere to become a true solution provider from hospitals, labs, near patient diagnosis. ]]> <![CDATA[Analytica Anacon India 2013 to be held in Mumbai]]> https://biospectrumindia.com/news/95/7174/analytica-anacon-india-2013-to-be-held-in-mumbai.html https://biospectrumindia.com/news/95/7174/analytica-anacon-india-2013-to-be-held-in-mumbai.html Mon, 11 Nov 2013 17:35:17 +0530 Analytica Anacon India 2013, the 7th International trade fair and conference for laboratory technology, analysis, biotechnology and diagnostics will be conducted from November 12-14, 2013 at Bombay Exhibition Center, Mumbai, India. The biennial event is a spin-off exhibition of the world's leading trade fair Analytica in Munich and was first conducted in the year 2003. The event is jointly organized by Messe Munchen International (MMI) and Indian Analytical Instruments Association (IAIA).Analytica Anacon India will attract visitors from various domains like, Pharmaceutical, Chemical and Petrochemical, Healthcare, Food, Electrical Engineering and Electronics, Medical Laboratory, Medicine, Universities, research Institutes and more. With the attendance of major international and domestic leaders in the sector of analytical instruments, the event promises to showcase innovative and high quality equipments. Innovation and scientific research is essential for economic development and growth of any nation. For a developing economy like India, it is even more relevant and important.K V Venugopalan, president, IAIA, said, "The Indian Analytical instrument market including consumable and spares is estimated at around $1billion with a growth rate of above 10%. This along with the rising demand and developments in food safety and pharmaceuticals production will help the industry to grow at a steady pace. There is a high dependence on import of technologies for research and at times they are not easily available for various commercial or legal reasons. The time has come to focus on developing cutting edge technologies and instruments in India that will give us advantage in the coming decades."Some of the key companies exhibiting this year at Analytica Anacon India are - Waters India, Agilent Technologies, Bruker AXS Analytical Instruments Pvt Ltd, Metrohm India Limited, GCE India Pvt Ltd, S.V Scientific, TA Instruments, LCGC Chrom Consumables, LLP, Labcon, Marsap, Contech Instruments, Eppendorf, Phenomenex India, Vishva Systems, Medispec Instruments, Merck Millipore. Also the event will have international pavilions from Germany, China, Japan."The last edition of Analytica Anacon India had experienced 182 exhibitors from 18 countries with 42% participation from International exhibitors. This year the event is expected to witness a significant increase in the number of visitors and exhibitors from the domestic as well as the International markets. Besides, product exhibits, a series of conferences addressed by domain experts will take place parallel to the exhibition. The event promises to be an ideal platform to generate new momentum for research, business and technology", said Mr. Darryl Dasilva, Chief Executive Officer, MMI India Pvt. Ltd. Technical sessions being organized by IAIA, parallel to the exhibition will be attended by users of analytical instruments from various segments of the industry such as pharmaceuticals, food and environmental, etc. and research and academic institutions.The theme of the conference of Analytica Anacon India this year is "Research and Regulations: Challenges for the Food, life Sciences and Pharmaceutical Industries." The presentations in the conference will touch upon topics like the highlights from the analysis, chromatography and biotechnology/life-sciences sectors and cover a wide range of information. During the past few years, the Analytica Anacon India Conference has developed into a competent into a competent, focused for the gathering for the entire industry markets in Asia.The conference -symposium focuses on the regulatory and patenting issues, standards, and safety, drug discovery and biosimilars. A special seen session by Prof. Dr.H.C.A Ketrup, (Technical University Munich, Dept of Ecological Chemistry and Environment) would be on quality control within the food and pharmaceutical industry, environmental analysis and drugs and metabolites. ]]> <![CDATA[Parliamentary standing committee to hold consultation on medicine distribution scheme]]> https://biospectrumindia.com/news/95/4473/parliamentary-standing-committee-to-hold-consultation-on-medicine-distribution-scheme.html https://biospectrumindia.com/news/95/4473/parliamentary-standing-committee-to-hold-consultation-on-medicine-distribution-scheme.html Mon, 11 Nov 2013 17:32:52 +0530 In order to provide relief to the common man in the area of healthcare, a countrywide campaign for ensuring availability of generic medicines at affordable prices to all, in the name of "Jan Aushadi Campaign" was launched by the ministry of chemicals and fertilizers (Department of Pharmaceuticals), government of India in November, 2008, in collaboration with the state governments, as a direct market intervention strategy. The medicines for the campaign are supplied by the Central Pharma PSU (CPSUs) under the department of pharmaceuticals. Under this campaign, it was proposed to open, initially, at least one store in each district of the country. As against the target of opening one JAS in each of the 630 districts, only 157 stores have been opened till September 30, 2013 in the states of Punjab, Haryana, Odisha, Andhra Pradesh, Rajasthan, Delhi, Uttrakhand, West Bengal, Jammu & Kashmir, Himachal Pradesh, Jharkhand and UT of Chandigarh. The details of the scheme may be assessed from the website www.janaushadhi.gov.in. Now, the department related standing committee on chemicals and fertilizers under the chairmanship of Mr Gopinath Munde, MP have taken up the Subject "Jan Aushadhi Scheme" for examination and report. With a view to have wider consultations and a holistic view on the subject, the Committee have decided to invite memoranda containing views and suggestions of experts, individuals, institutions, organizations and other stakeholders interested with the subject matter on the issues such as creation of awareness in public at large about the Jan Aushadhi Scheme and generic medicines; methodology involved including the prices of medicines; access to quality medicines at affordable prices for all; prescription of the generic medicines by the government and private doctors; availability of all the essential and listed medicines at Jan Aushadhi Stores; major bottlenecks faced by stockists, Jan Aushadhi Stores, NGOs, hospitals, Charitable/ Cooperative/ Government Bodies including Red Cross Societies and the State Governments affecting the smooth implementation of the scheme, etc. The Committee would, thereafter, also take oral evidence on the subject. Those who wish to appear before the Committee, besides submitting memorandum, are requested to specifically indicate so. However, the Committee's decision in this regards shall be final. The memorandum submitted to the Committee would form part of the records of the Committee and would be treated as strictly 'Confidential' and not circulated to any one, as such an act would constitute a breach of privilege of the Committee. ]]> <![CDATA[Videocon Telecom introduces M-health; launches mobile based Ayurvedic health service]]> https://biospectrumindia.com/news/95/7794/videocon-telecom-introduces-m-health-launches-mobile-based-ayurvedic-health-service.html https://biospectrumindia.com/news/95/7794/videocon-telecom-introduces-m-health-launches-mobile-based-ayurvedic-health-service.html Fri, 08 Nov 2013 16:39:50 +0530 Videocon Telecom, the telecom brand of the Indian conglomerate Videocon Group, has introduced specialized Ayurvedic mobile health service for its subscribers. This wellness service is developed in collaboration with world renowned JIVA Ayurveda Group and offers specialized Ayurvedic treatment to the masses. These days consumers are getting more inclined towards holistic treatment and are looking at Ayurveda as an effective mode of treatment. This first-of-its-kind mobile based Ayurvedic health service will provide access to top Ayurvedic doctors round-the-clock and is exclusively available by dialling 535133, which is chargeable at Rs. 6/min. To bring the health service to the masses, Videocon Telecom has partnered with Think Health Services which is a leading provider of mobile health and wellness related products and services. Through this service the subscribers can speak with a Certified Ayurveda Expert to discuss health problems and seek treatment advice. Post consultation, they can order their medicines directly on the phone. The medicines will be delivered to their homes across 1300 cities all over India on a Cash-on-Delivery basis. The service is managed through Asia's largest Ayurveda Telemedicine Center with a panel of over 150 doctors. With the world turning increasingly towards alternative medicine for holistic treatment and with Ayurveda gaining immense popularity, this one-of-its-kind service will enable the subscribers in receiving the consultation and treatment right onto their mobile phones. Mr Arvind Bali, director and CEO, Videocon Telecom said, "We are pleased to roll out the M Health service for our subscribers. Ayurveda is not just a treatment but a way of life which helps maintain one's health from the outset. With the launch of this service, we seek to bring convenience and affordable healthcare services to our consumers. This new service shall enable our subscribers to get in touch directly with certified Ayurvedic doctors round the clock and discuss their health issues and seek treatment advice. Now with this service one can access health related help and consultation anywhere and anytime, and also can order medicines which are directly delivered onto their doorsteps." "We are committed in improving the lifestyle of our customers, and aim to raise awareness on healthcare through this one of its kind health service. Our latest venture into the M-VAS sector is sure to herald more innovations in coming times which will bring greater ease into the consumers' lives", he added. ]]> <![CDATA[Technology and innovation need greater attention: SAC ]]> https://biospectrumindia.com/news/95/8338/technology-and-innovation-need-greater-attention-sac-.html https://biospectrumindia.com/news/95/8338/technology-and-innovation-need-greater-attention-sac-.html Fri, 08 Nov 2013 16:35:05 +0530 The Science Advisory Council (SAC) to the prime minister in the department of science and technology (DST) has emphasized upon paying much greater attention in the technology and innovation sector.10. Eliminate bureaucracy and outdated procedures which dominate the management of education, science and technology today so that these sectors are freed from serious impediments. Governance reforms are badly needed in our universities, specially state universities which carry the excessive burden of affiliated colleges. The council has also appealed to the planners, policy makers and concerned citizens to keep in mind the high aspirations of young India and the constant demand for a better quality of life for all our citizens, both of which require more purposeful effort and committed investment in science, technology and innovation (STI). The Council is chaired by Mr C.N.R. Rao. The other members are Mr S Ayyappan, P Balaram, Baldev Raj, Mustansir Barma, M K Bhan, S K Brahmachari, Avinash Chander, R Chidambaram, S E Hasnain, Ashok Jhunjhunwala, Kiran Karnik, V M Katoch, D V Khakhar, R A Mashelkar, Goverdhan Mehta, Shailesh Naik, Roddam Narasimha, Swati Piramal, K Radhakrishnan, Sujatha Ramadorai, T V Ramakrishnan,P Rama Rao, T Ramasami, M M Sharma, V K Singh, Bikash Sinha, R K Sinha, A K Sood, Venu Srinivasan, B K Thelma and K VijayRaghavan. Accordingly, with the belief that STI forms the very foundation of all national effort, the SAC has strongly recommended that much greater attention be paid to this sector in the years to come. This requires not a mere increase in investment in S&T from the present roughly 1% of the GDP to the promised 2% of the GDP, but also the moral and intellectual support of society as a whole to STI. With such support and the conviction that the our national interests will be greatly served by integrating STI into economic and societal policies, the country should be able to succeed in solving the serious problems that it faces in the next two or three decades, and be counted as a major contributor to STI. Only then, India will be able to have several of our institutions in the top 50 or 100 in the world. The Council has noted that in the last few years India has begun to emerge as a more significant global player in many areas of science and technology. The country is respected for the outstanding professionals it has produced and for the contributions it has made to various important sectors of S & T. In parallel, India has improved its infrastructure in science and technology substantially in the last two or three decades. Thus, several areas of S&T have been reorganized (e.g., in earth sciences and medical research) and new educational institutions have been set up (e.g., IISERS and more IITs). New Fellowships such as the Ramanujan Fellowships have been created to encourage young talent. And there are several institutions with research and development programmes that could contribute to the solution of some of the societal problems facing India. While there are many positive changes in the S&T scenario, the rate of change could be faster. This is partly because our national aspirations are rising fast. At the same time, international competition in science and technology has grown, and indeed become severe. Global Innovation Index 2013 places India at the 66th position amongst 142 nations. In scientific research, while India's contribution to the global output has increased, it still remains only at a modest level with no sign of a major upward swing in quantity or quality. While India is progressing, others are progressing faster. Thus, some of our neighbouring countries have invested much more in people, institutions and infrastructure, and harvested the benefits of science, technology and innovation (STI) to achieve dramatic economic growth and to provide for better education and health-care, and have moved ahead rapidly towards becoming members of the developed world. The Council expressed concern on the fact that India's performance in higher education has also not been altogether satisfactory, and we have very few institutions that can be found in the top category in international rankings. It Emphasized on making a serious effort to improve the situation, if we have to move towards becoming a global player. In Council members opinion since science, technology and innovation (STI) are essential ingredients of growth and development as well as the general well-being of our society as a whole, it is necessary to seriously ponder over the greater demands being made on our STI efforts in the present world scenario. Science-led innovation has to dominate our developmental efforts, providing the necessary strong base to become competitive internationally, and to become economically strong and socially just. While one may find reasons to be satisfied with the progress that has occurred in the science and technology sector since we gained freedom, it is necessary to keep in mind the high aspirations of young India and the constant demand for a better quality of life for all our citizens, both of which require more purposeful effort and committed investment in STI. If we embark on focused efforts to accomplish the objectives stated above, we will not remain spectators in a world that will be progressing at a fast pace in economic, social and educational sectors, but will carve for ourselves a position in the league of global leaders. There is every reason to believe that the science and technology sector will gladly bear the increased responsibility needed today, the council has further observed. In this connection the council has strongly recommended that the following steps be taken with a sense of urgency. 1. Create a strong innovation ecosystem that nurtures science-led innovation, which would include among other things a policy that encourages strong interactions between S&T and industry, so that new Indian products and systems based on new ideas emerge in a competitive world market and India emerges as a global leader in STI. 2. Increase investment in science and technology and education, including higher education in general: In all such efforts, it is important that the private sector contributes significantly. Increase in private sector investment in R&D and its partnership with the public sector in translational research is crucial. It is necessary that dialogues on new technologies and mega projects are based on reliable evidence and experience rather than emotions and individual preferences. 3. Support outstanding individuals, groups and institutions with sufficient long-term funding so that they are able to contribute significantly and become internationally competitive. 4. Identify and generously support major national S&T initiatives that can lead to game-changing solutions to our pressing problems. 5. Eliminate bureaucracy and outdated procedures which dominate the management of education, science and technology today so that these sectors are freed from serious impediments. Governance reforms are badly needed in our universities, specially state universities which carry the excessive burden of affiliated colleges. 6. Create a strong innovation ecosystem that nurtures science-led innovation, which would include among other things a policy that encourages strong interactions between S&T and industry, so that new Indian products and systems based on new ideas emerge in a competitive world market and India emerges as a global leader in STI. 7. Increase investment in science and technology and education, including higher education in general: In all such efforts, it is important that the private sector contributes significantly. Increase in private sector investment in R&D and its partnership with the public sector in translational research is crucial. It is necessary that dialogues on new technologies and mega projects are based on reliable evidence and experience rather than emotions and individual preferences. 8. Support outstanding individuals, groups and institutions with sufficient long-term funding so that they are able to contribute significantly and become internationally competitive. 9. Identify and generously support major national S&T initiatives that can lead to game-changing solutions to our pressing problems. ]]> <![CDATA[Azad offers Indian support to BRICS nations on health surveillance system ]]> https://biospectrumindia.com/news/95/7115/azad-offers-indian-support-to-brics-nations-on-health-surveillance-system-.html https://biospectrumindia.com/news/95/7115/azad-offers-indian-support-to-brics-nations-on-health-surveillance-system-.html Thu, 07 Nov 2013 15:27:15 +0530 The union health and family welfare minister, Mr Ghulam Nabi Azad, in his speech at the third BRICS health ministers meet, assured the other nations that are part of the association, of full support and urged them to ensure enhanced cooperation. Azad mentioned that BRICS has emerged as a valuable forum for consultation, coordination and cooperation on contemporary global issues of mutual interest. BRICS represents about 43% of the world's population and is acting as a new growth and governance pole in a multi-polar world. The health minister stated that India can contribute towards five critical areas- health financing; health services administration including hospital administration; institutional reforms and appropriate use of available medical technology; human resource development; and access to essential drugs including a robust supply chain management and community participation. India being the lead country for thematic area health surveillance system, Azad offered to hold a workshop in India of nodal points and other key stakeholders in March/April, 2014 to map the best possible way forward.He also offered arranging visits to some of Indian states to show the surveillance system for disease control programmes. The Minister suggested that Non-Communicable Diseases (NCDs) should be included in the health surveillance systems and he welcomed the proposed formal meetings during 11-15 November, 2013 with WHO Member States to complete the work on a draft terms-of-reference for a global coordination mechanism for NCDs on NCD action plan indicators and terms of reference for the UN Inter-agency Task force on NCDs. The minister proposed enhanced cooperation among BRICS countries in medical education and training, capacity building, quality healthcare at an affordable cost, biotechnology, drug discovery and development as well as in the development of diagnostics, therapeutics and vaccines and traditional Indian medicines. The first formal BRICS health ministers meeting was held in Beijing, China in July, 2011 where the Beijing Declaration was adopted whereas the second BRICS health ministers meeting was organized in New Delhi in January 2013, where joint action plans were agreed upon for the thematic areas and a joint Delhi CommuniquÃ© was released. Present at the occasion were Dr Pakishe Aaron Motsoaledi, minister of health, South Africa, Mr Alexandre Padilha, minister of health, Brazil, Ms Veronika Skvortsova, minister of healthcare , Russia, Ms Li Bin, minister of health, China, Dr Luis Sambo, regional director, World Health Organisation, Mr Michel Sidibe, executive director, UNAIDS and various other dignitaries. ]]> <![CDATA[Robust regulatory system for evaluation of GM crops necessary says Anwar]]> https://biospectrumindia.com/news/95/6369/robust-regulatory-system-for-evaluation-of-gm-crops-necessary-says-anwar.html https://biospectrumindia.com/news/95/6369/robust-regulatory-system-for-evaluation-of-gm-crops-necessary-says-anwar.html Wed, 06 Nov 2013 16:55:00 +0530 The minister of state for agriculture and food processing industries, Mr Tariq Anwar on November 05, 2013 stated that use of better technologies can help us to achieve our primary goal of food security even if availability of land and water is kept constant. "We just need to use these resources more judiciously," he emphasised. Mr Anwar was speaking at the inauguration of World Agriculture Congress at Hyderabad on November 05, 2013. The topic for this occasion is "Congress on Reshaping Agriculture for a Sustainable Future". Inauguration of the Congress was attended by Andhra Pradesh Chief Minister, Shri N. Kiran Kumar Reddy, Minister for Agriculture, Andhra Pradesh, Shri K. Lakshmi Narayana, and Chairman of the WAF Advisory Board, Shri James Bolger. Scientists and businessmen were also participated in the Congress. Stating that Bio-technology is expected to play a major role in improving productivity, the minister said "what is needed is Robust Regulatory System which has scientifically established mechanism for evaluation of GM Crops so that all the issues raised on this matter can be put to rest. On this issue he reiterated the request made by Hon'ble President wherein he had ex-horted the Scientific Community and ICAR to contribute to the public discourse and provide clarity on this sensitive issue". Anwar further said that "contract farming and value addition of Indian food through food processing would play a major role in improving agricultural productivity as well as providing economic return for agricultural produce. Contract farming can provide the close hand holding regarding seed selection, seed treatment, soil testing, fertilizers, pest management and income support through procurement which Government programme cannot possibly provide". The minister also said that Indian agriculture faces a number of serious challenges like shrinking land, depleting water resources & inefficient water use, adverse impact of climate change, ineffective management of energy resources, shortage of farm labour, poor and inefficient market infrastructure, lack of access to appropriate technology, increasing cost and uncertainties of domestic and international markets and the biggest challenge which the country would be facing in the coming years shall be how to ensure food security in face of constantly growing population. Underlining measures to tackle impact of climate change on Indian agriculture, minister said that steps are being taken to mitigate the impact of climate change. Among the various areas in which interventions are being planned include improved crop seeds, livestock and fish culture, water efficiency, pesticides management, nutrient management, agriculture insurance, market access and livelihood diversification. Anwar further informed that Indian Council for Agriculture Research(ICAR) has initiated a network project "National Initiative on Climate Resilient Agriculture"(NICRA) aiming at enhancing resilience of Indian agriculture through Strategic Research, Technology Demonstration and Capacity Building. ]]> <![CDATA[Infosys Prize 2013 to be announced on Nov 12]]> https://biospectrumindia.com/news/95/3960/infosys-prize-2013-to-be-announced-on-nov-12.html https://biospectrumindia.com/news/95/3960/infosys-prize-2013-to-be-announced-on-nov-12.html Tue, 05 Nov 2013 18:46:00 +0530 The prize winners will include eminent people hailing from various categories including engineering and computer science, humanities, life sciences, mathematical sciences, physical sciences and social sciences. The event's welcome note will be delivered by Mr Srinath Batni, president of the board of trustees, Infosys Science Foundation. The winners' announcement will be done by the trustees of the Infosys Science Foundation including Mr Srinath Batni, Mr Narayana Murthy, Mr S D Shibulal, Mr V Balakrishnan, and Mr K Dinesh. ]]> <![CDATA[Eisai supplies DEC tablets to WHO]]> https://biospectrumindia.com/news/95/4118/eisai-supplies-dec-tablets-to-who.html https://biospectrumindia.com/news/95/4118/eisai-supplies-dec-tablets-to-who.html Tue, 05 Nov 2013 18:16:00 +0530 In its endeavor to help WHO in its global effort to help eliminate lymphatic filariasis (elephantiasis) in the targeted developing and emerging countries, Eisai has agreed to supply 2.2 billion DEC tablets freely to WHO for use in national mass drug administration (MDA) programs. Lymphatic filariasis, commonly known as elephantiasis, is a parasitic disease transmitted to humans by mosquito bites. Currently, an estimated 120 million people are already affected and more than 1.4 billion people are at risk of this disease, globally. The company said that an estimated 6.25 million people living in at-risk communities will benefit from MDA programs. The Pacific Island nations of Papua New Guinea, Kiribati, Tuvalu and Fiji have been confirmed as the first countries to receive the initial shipment, said the company's press release on Tuesday. ]]> <![CDATA[Strategic IP management programme for biopharma industry]]> https://biospectrumindia.com/news/95/7172/strategic-ip-management-programme-for-biopharma-industry.html https://biospectrumindia.com/news/95/7172/strategic-ip-management-programme-for-biopharma-industry.html Tue, 05 Nov 2013 13:11:30 +0530 It is very important that the pharma and biotech companies know how to deal with issues on labour and financial capital, manage their IP, including patent protection of their inventions. Intellecual property rights (IPR), especially in the form of patents, is very important for companies producing new drugs in the pharmaceutical industry, because a substance patent for pharmaceuticals provides extensive coverage for property rights, a small number of patents can cover one new drug and each patent is extremely valuable. Therefore, the three day programme on Strategic IP Management for the Pharma and Biotech Sector to be held from November 20 to November 22, 2013, isexpected to provide a platform to create and foster innovation and IP culture in various organizations and discuss on various IP management strategies and tools used for sustainable development of an enterprise. The programme will help in gaining an insight into best practices in managing IP assets in an organization. The objectives of the Programme will be to strategic use of intellectual property rights and IP Management to gain and sustain competitive advantage, to understand the role to IP Management in any industry's structure, learn about what options do IP Management offer vis-Ã -vis competitors. Apart from that, the programme includes discussions on IPR role to chalk out a road map for an organizational design that accommodates an intellectual property strategy most effectively. Also to harness the importance of IP managenement for a company to gain vertical power along the value chain is also on the agenda. ]]> <![CDATA[India Lab Expo 2013 begins this November]]> https://biospectrumindia.com/news/95/5538/india-lab-expo-2013-begins-this-november.html https://biospectrumindia.com/news/95/5538/india-lab-expo-2013-begins-this-november.html Tue, 05 Nov 2013 12:13:00 +0530 This expo will serve as a common base in India for manufacturers and distributors from all over the world, leveraging the opportunity to showcase their latest products and technology to buyers and users. The exhibition will also offer wide door of opportunities to various participants to connect with global leaders, learn about cutting-edge technology, know vital researches and appreciate the changes the industry is going to witness in the future. The event will focus on latest trends and technology in the area of laboratory and analytical instrumentation, chromatography & spectroscopy, biotechnology and life sciences, process control & reactors, medical and clinical diagnostics, clean room & sterilization, quality control & environment, educational labs, measurement & testing, liquid handling & filtration, laboratory consumables & allied products, laboratory furniture and construction. Participants can also look forward to new business leads and deals, connecting with key decision makers in buying organizations, networking with professional peers, government officials and regulatory agencies. This year, more than 50 foreign companies from an array of countries including Germany, USA, UK, Hungary, Switzerland, Italy, Canada, China, South Korea, Russia, Taiwan and Sweden are anticipated to directly participate in this expo. In totality, the expo is expected to be inundated with 300+ exhibitors and more than 10,000 visitors representing diverse industries. ]]> <![CDATA[ Indian Pharmacopoeia extends outreach]]> https://biospectrumindia.com/news/95/7218/-indian-pharmacopoeia-extends-outreach.html https://biospectrumindia.com/news/95/7218/-indian-pharmacopoeia-extends-outreach.html Mon, 04 Nov 2013 16:16:00 +0530 The union health and family welfare minister, Mr Ghulam Nabi Azad released the 7th edition of 'Indian Pharmacopoeia 2014 - a book of drug standards' in New Delhi on November 04, 2013. The minister congratulated the Indian Pharmacopoeia Commission and the expert members of the Scientific Body, IPC staff and various other professionals and organizations for this achievement. Speaking on the occasion, Azad said that there have been rapid changes in the standards of drug all over the world and to keep pace with the regulatory requirements, it was felt necessary by all the stakeholders to bring out the new edition of the Indian Pharmacopoeia 2014 at the earliest. "The standards given in this pharmacopoeia are authoritative, legally enforceable and intended to help in the inspection and licensing of manufacturing units and distribution of drugs and pharmaceuticals," mentioned the minister. He further noted that Indian Pharmacopoeia 2014 has been considerably revised and improved by introducing advanced technology and experimental methods widely adopted in India and abroad. The seventh edition of the Indian Pharmacopoeia (IP 2014) has been published by the Indian Pharmacopoeia Commission (IPC) in fulfillment of the requirements of the Drugs and Cosmetics Act, 1940 and Rules thereunder. It prescribes the standards for drugs produced and/or marketed in India and thus contributes in the control and assurance of the quality of the medicines.The Indian Pharmacopoeia 2014 is presented in four volumes. The scope of the Pharmacopoeia has been extended to include products of biotechnology, indigenous herbs and herbal products, veterinary vaccines and additional antiretroviral drugs and formulations, inclusive of commonly used fixed-dose combinations. Standards for new drugs and drugs used under National Health Programmes are added and the drugs as well as their formulations not in use now a days are omitted from this edition. The IP 2014 incorporates 2548 monographs of drugs out of which 577 are new monographs consisting of APIs, excipients, dosage forms, antibiotic monographs, insulin products and herbal products etc. 19 New Radiopharmaceutical Monographs and 1 General chapter is first time being included in this edition. It is hoped that this edition would play a significant role in improving the quality of medicines which in turn promote public health and accelerate the growth and development of Pharma Sector. Present at the occasion were Mr K N Desiraju, secretary, health and family welfare, Dr V M Katoch, secretary, department of health research and DG, ICMR, Dr Nata Menabde, WHO Representative and various other dignitaries. ]]> <![CDATA[Granules India to acquire Auctus Pharma and opens new R&D facility]]> https://biospectrumindia.com/news/95/7824/granules-india-to-acquire-auctus-pharma-and-opens-new-rd-facility.html https://biospectrumindia.com/news/95/7824/granules-india-to-acquire-auctus-pharma-and-opens-new-rd-facility.html Mon, 04 Nov 2013 16:13:00 +0530 "The acquisition of Auctus fits into our strategy of being a fully integrated manufacturer while diversifying our product portfolio by adding high-value products with significant market demand. We will be a market leader by implementing our operational excellence philosophy while leveraging Auctus' regulatory approvals. In order to accelerate growth with a sustainable development engine, we have established a new R&D facility to enable finished dosage filings for our new APIs," said Mr Krishna Prasad, managing director, Granules India. Currently, Auctus has two manufacturing facilities, an API facility in Vishakhapatnam and an intermediate facility in Hyderabad. The API facility has approvals from regulatory agencies including the US FDA, EDQM and KFDA. Auctus' APIs therapeutic categories includes Antihistaminic, Antihypertensive, Antithrombotic and Anticonvulsant. Granules also announced the opening of its 10,000 sq. foot R&D facility in Hyderabad. The new R&D is expected to focus on full scale generic API development and will supplement the company's existing R&D facility in Pune, which focuses on sustainable technology development. "The acquisition is one part of our three-pronged growth strategy. We remain committed to building on our position as a global leader for our existing products. We will continue to strengthen our lead over others by focusing on continuous improvements and capacity enhancements in existing and new products," said Mr Harsha Chigurupati, executive director, Granules India. ]]> <![CDATA[Drug discovery â€“ How is India doing? : Mr J B Gupta]]> https://biospectrumindia.com/news/95/5089/drug-discovery-how-is-india-doing-mr-j-b-gupta.html https://biospectrumindia.com/news/95/5089/drug-discovery-how-is-india-doing-mr-j-b-gupta.html Sat, 02 Nov 2013 10:55:00 +0530 Titled, 'Drug Discovery - How is India doing?', the topic was presented by Mr J B Gupta, Senior VP, GVK Biosciences. In his presentation, Mr Gupta presented the major milestones achieved based on which drug discovery progress is measured. He mentioned the following milestones: Post TRIPS and focus on drug discovery (1994); out-licensing of proprietary molecules (1998); discover progress collaboration (2003); and launch of proprietary molecules (2012). He said, "Drug discovery process and expertise should address the issues and challenges. When there is an unmet need, you need to understand the disease pathology, and then you discover a molecule and carry out trials." Mr Gupta said that new drug R&D has been started by several Indian pharma companies but it has been very difficult to discover a molecule up to the launch. Talking about the issues and human resources challenges faced in the Indian drug discovery scene, Mr Gupta expressed, "We have very good academic network and graduates who are going for master's and PhD programs and not getting properly trained. We don't have good infrastructure to train them." He continued, "Human resource crunch is a major issue here. We are trying to fill this gap through getting people from US and Europe." Mr Gupta considers that funding and investments by very few companies isn't sufficient. "There is hardly any funding provided. We do not see any risk- based venture capitalists available in the country or outside India. The government has started funding, but they are in no way adequate to meet the challenges we have. We only invest 0.8% of our GDP in our R&D," he said. Addressing the poor quality of academic research in the country, Mr Gupta stated, "Our publication volume and quality of research is very less and we are lagging behind US and China. The quality of journals and research articles in India is not that great. We have made substantial progress in the past 15 years. But we still have miles to go." ]]> <![CDATA[Unique challenges in vaccine development: Dr Rajat Goyal]]> https://biospectrumindia.com/news/95/2982/unique-challenges-in-vaccine-development-dr-rajat-goyal.html https://biospectrumindia.com/news/95/2982/unique-challenges-in-vaccine-development-dr-rajat-goyal.html Fri, 01 Nov 2013 11:53:00 +0530 The DIA's three-day 8th Annual Conference on October 24, 2013, at the NIMHANS Convention Center, Bangalore, hosted a post-lunch session on 'Unique Challenges in Vaccine Development', presented by Dr Rajat Goyal, Country Director, IAVI (The International AIDS Vaccine Initiative) India. Dr Goyal said that if we are treading on traditional pathways in developing vaccines for certain diseases like cancer, TB, malaria and HIV, it is going to be a 'financial nightmare' and 'scientifically challenging'. Talking about the significant issues that exist in the R&D of vaccines, Dr Goyal added, "The proof of concept has to be well established before we enter into humans.... The efficacy of the drug has to translate into effectivity." He further emphasized on the importance of using technology in the development of vaccines. He expressed, "If you are using technology to study human immunology, then you will also be able to use the same technology to understand disease physiology and disease pathology." Speaking about the government's role in the area of vaccine development, Dr Goyal added, "If we need to see the vaccines of the future, we need to encourage all stakeholders, right from discovery and development, till evaluation. The government has to help and sustain the efforts by being ready to invest at risk. Though the demand is high, the future will be bright." Dr Goyal concluded his presentation by saying, "India recognizes the challenges in vaccine research.... If we want to raise the bar, we need to use our manufacturing expertise." ]]> <![CDATA[Merck India provides solution to overcome counterfeiting]]> https://biospectrumindia.com/news/95/5520/merck-india-provides-solution-to-overcome-counterfeiting.html https://biospectrumindia.com/news/95/5520/merck-india-provides-solution-to-overcome-counterfeiting.html Thu, 31 Oct 2013 17:54:42 +0530 According to the World Health Organization (WHO), up to 30% of drugs sold in developing nations are branded drugs which are counterfeited. What was once confined to exotic and costly pills has now proliferated to cough syrups, vitamins supplements, painkillers and the like. India being the largest supplier of generic drugs and yet a price-sensitive market, serves as a breeding ground for cheap imitations. The network behind this activity thrives on the Indian consumer's ignorance, appetite for branded goods and their innate nature to bargain. Counterfeiting causes huge losses to the state which loses out on revenue by way of taxes on goods. A FICCI survey estimated the loss of the Indian exchequer by way of taxes to be roughly around Rs. 1,000 crore every year. On the human side, every year many lives are lost to counterfeit drugs and medicines. A report in the Washington Post suggests that an estimated 12 to 25% of all drugs sold within India are thought to be counterfeiting of products continues to be a bane to the Indian economy while also inflicting serious damage on its reputation globally. Thus, companies today need to pay special attention to brand security and authentication when designing new products. This can be done by ensuring product and packaging differentiation. Merck India's Performance Materials Division, helps manufaturers with brand protection concepts and security solutions thereby reducing health hazards and also increasing safety of consumers. These customised solutions include: Overt Solutions: The visible visual effect of interference or colour changing pigments that helps the consumer distinguish between genuine and imitation packaging without the use of a verification device. Covert Solutions: Decorative or security pigments combined with additives which are recognizable only with technical means. Examples include taggants that become visible in infrared light. Forensic Solutions: Product protection of higher risk value products helps to prevent terrorism, forgery and lawsuits. Merck's decorative and security pigments can be combined with special additives that can only be consistently identified and authenticated via high-tech analytical methods. There are two products from Merck's sizeable portfolio, which are used in offering customised anti-counterfeiting solutions: Securalic security concepts help in making counterfeiting of consumer and industrial goods next to impossible with conventional tools and methods. They can be easily integrated into an existing product design and cost- efficiently incorporated into an establish fabrication procedure for printing and plastic manufacturing. Candurin is a pearl effect pigment especially for the pharmaceutical industry in India. Following a sophisticated manufacturing process, these colorants are coated on thin, natural and semi-transparent silicate platelets. This new physical structure give rise to the unique optical properties that are innovative and eye-catching. Merck can create, for every brand protection programme an individual security solution whose specific elements are revealed only to the respective manufacturer. Commenting on this, Mr. Siddhartha Sengupat, Regional Sales Director Asia (Decoratives) nsaid, "Defending your brand's equity assumes greater prominence in today's day and age. Anti-counterfeiting solutions not only guard a brand but also protect the financial health of the business. Merck recongnizes this and offers customized solutions across verticals that aid unique identification and product differentiation. We believe that rather than being a victim of piracy, you could be part of the solution." ]]> <![CDATA[Over 250 cochlear implants conducted in Mumbai in 2012-13]]> https://biospectrumindia.com/news/95/8168/over-250-cochlear-implants-conducted-in-mumbai-in-2012-13.html https://biospectrumindia.com/news/95/8168/over-250-cochlear-implants-conducted-in-mumbai-in-2012-13.html Thu, 31 Oct 2013 17:52:31 +0530 P.D Hinduja Hospital anchored the 8th Cochlear Implant workshop. The workshop was attented by 35 doctors, 20 audiologists, 15 therapists (from all over India) and students. The workshop aimed at providing essential information about cochlear implants and help professionals to enhance their skill-set for such surgeries. Over the past 7 years Dr. Millind Kirtane, has trained over 100 surgeons through these workshops and helped many of them establish their own cochlear implant programs, including general hospitals like KEM, Nair and Sion Hospital. Dr Kirtane, Consultant ENT Surgeon at Hinduja Hospita,l who spearheaded the workshop has an experience of more than four decades as ENT surgeon. He himself has conducted about 5ooo cochlear implants operations till date, and has been imparting education and training to juniors. Hinduja hospital has been a pioneer in conducting cochlear implants and does more than 100 implants now every year. A hearing disability can strike at any age and for any reason. In severe to profound deafness where hearing aids fail to help the patient, cochlear implant can help significantly. In new-borns hearing disability can be identified very early, and so it is imprtant that there are trained professionals who can diagnose problems early. Speaking on this occasion Dr. Kirtane said, "The number of cases reported has increased manifold in the last three years, which is a result of awareness among the common man. Hence our objective of this workshop is to ensure we train professionals so that they can augment their skills and work towards providing better healthcare facilities to patient in even remote parts of India." The success of cochlear implant case not only depends on the surgery performed, but also on the therapist and audiologists efforts on the case. Typically the therapists and audiologists work with the patient for 2-3 years post surgery. ]]> <![CDATA[Drugs and cosmetics amendment bill must consider stakeholder views, urges medical device industry]]> https://biospectrumindia.com/news/95/8431/drugs-and-cosmetics-amendment-bill-must-consider-stakeholder-views-urges-medical-device-industry.html https://biospectrumindia.com/news/95/8431/drugs-and-cosmetics-amendment-bill-must-consider-stakeholder-views-urges-medical-device-industry.html Thu, 31 Oct 2013 17:49:45 +0530 With the winter session of Parliament approaching, the Advance Medical technology Association (AdvaMed) along with other representatives of the medical device industry has urged the Parliamentary Standing Committee on Health and Family Welfare to consider their recommendations for the Drugs & Cosmetic (Amendment) Bill 2013 so that the benefits of the bill can result in faster and safer solutions for Indian patients and more investments for the country. The various organisations and trade bodies in their submissions have made detailed recommendations which should be considered when the Bill is passed, which could otherwise pose the risk of shortchanging the potential benefits medical device industry can bring to the country. India has traditionally had an overwhelming burden of communicable diseases, but non-communicable diseases (NCDs) are fast emerging to be the country's next public health challenge. The World Health Organization, NCD Country Profiles, 2011 states that more than 53% of total deaths every year in India are due to NCDs and by 2020, over 60 million Indians will succumb to them. Medical devices play an increasingly critical role in the diagnosis and management of NCDs. As India strives to provide universal health facilities to its citizens, medical technology will become an even more integral part of the country's public health system as these help in the diagnosis and management of complex non-communicable diseases, thereby alleviating pain, restoring health and extending life of the people. However, in its present form, there are some significant aspects of the Bill that could stifle this enthusiasm even before the potential and utility of medical technology can be fully realized. AdvaMed in its submission has suggested that all the regulations for medical devices are harmonised with international best practices such as the International Organization for Standardization (ISO) and International Medical Device Regulators Forum (IMDRF), so that medical device manufacturers achieve the highest standards of safety and efficacy and also become globally competitive. The suggestions also highlight adoption of risk based approach to ensure timely access to medical technology and revision of provisions related to clinical trials to maintain highest ethical standards. Ms. Abby Pratt, Associate Vice President, Global Strategy & Analysis at AdvaMed states, "The medical device industry is encouraged by the Bill for recognizing medical devices as a separate and critical element of the Indian healthcare delivery system, and believes that the Bill will improve the industry's ability to serve India's growing healthcare needs in a safe, effective and timely manner. We congratulate the government for introducing the bill and thank the Parliamentary Standing Committee for soliciting our suggestions. AdvaMed and its member companies stand ready to participate as full partners in India's effort to improve the quality of life for all its citizens". Currently, the industry is concerned about the lack of standardisation in line with global best practices like the Global Harmonization Task Force (GHTF) and the IMDRF. Some of the penal provisions as defined in the Bill, where even minor violations attract severe penal action often disproportionate to the nature or severity of the crime, are not in line with international practices. The Bill also needs to clarify the terms 'manufacture' and 'manufacturer', as appropriate to medical devices (Presently, the same definitions as applicable to drugs have been used for devices.) At a broader level, the Bill recognizes the fact that medical devices are different from drugs, but the distinction needs to be carried to the last mile. In keeping with the proactive spirit of introducing the Bill, the industry is hopeful that adequate consideration and deliberation will take place ahead of the passing of the Bill, and that it can contribute meaningfully to the formulation of the Bill. ]]> <![CDATA[Clinical evidence needed in vaccine safety and efficacy: Mr Raj Shankar Ghosh]]> https://biospectrumindia.com/news/95/4837/clinical-evidence-needed-in-vaccine-safety-and-efficacy-mr-raj-shankar-ghosh.html https://biospectrumindia.com/news/95/4837/clinical-evidence-needed-in-vaccine-safety-and-efficacy-mr-raj-shankar-ghosh.html Thu, 31 Oct 2013 17:10:00 +0530 The session was addressed by Mr Raj Shankar Ghosh, Interim Deputy Director, Vaccines Delivery, India, Bill and Melinda Gates Foundation. In his presentation, Mr Ghosh expressed that in the past five years, India's vaccine development industry has made proud contributions. He said, "There has been concerns around the introduction of new vaccines and their access and delivery. About 15 years ago we promised to make India a Polio-free nation and today it is a reality. We still have other promises to keep in scaling up on vaccine programs." Mr Ghosh expressed that the government of India has set the tone for scaling up of vaccines. "In this regard, it shows 3 aspects. Firstly, scaling up in terms of number of children immunized i.e., the reach of vaccines in the remote corners of India like places in Uttar Pradesh, Bihar, Rajastan and Madhya Pradesh, where there are big challenges." He further said, "Secondly, it is in terms of quality of vaccination and thirdly, scaling up in terms of introduction of vaccines." Commenting about the strategies involved in the introduction of new vaccines, Mr Ghosh opined, "There is a lot of disease burden. There need to be strong evidence for new vaccines. Secondly, there needs to be clinical evidence around the safety and efficacy of the product, followed by opportunities, where we have to leverage the right time and opportunity for the introduction of new vaccines." He concluded by saying, "Many vaccines come at high price with no mass production taking place. There has to be feasibility of inclusion of the product within India or other countries. Also, the preparedness of the country to accept the new vaccine is also important, which are all policy level decisions that need to be addressed." ]]> <![CDATA[Bangladesh to opt for Bt brinjal, Indian activists skeptical]]> https://biospectrumindia.com/news/95/6301/bangladesh-to-opt-for-bt-brinjal-indian-activists-skeptical.html https://biospectrumindia.com/news/95/6301/bangladesh-to-opt-for-bt-brinjal-indian-activists-skeptical.html Thu, 31 Oct 2013 17:10:00 +0530 The National Committee on Biosafety (NCB), Bangladesh which is the country's regulatory authority to approve genetically modified crops, has given its approval to the commercial cultivation of the Bt brinjal. The approved varities developed by the Bangladesh Agricultural Research Institute (BARI) with the help of technology, actually transferred by the India based Maharashtra Hybrid Seeds Company (Mahyco. This surely means a good news for Indian industry which of late has been disappointed by the continous moratorium on the Br crops. Once Bangladesh allows cultivation of GM food crops, the existing moratorium on Bt Brinjal in India will have no meaning as the transgenic variety of this popular vegetable can easily seep into Indian side through porous border. Hence, government might have to by default agree to the industry demands in the long run as in case of Bt cotton, which now is counted among the big success stories in agricultural space. This might also as well, become a good case of arguement in Supreme Court, where there is an ongoing case being batlled out between pro and anti am stakeholders. At the same time, the anti-GM food groups based in Delhi have sought government's ntervention under international convention and protocol to halt the Bangaldesh from doing so. The organizations believe that the move may endanger rich biodiversity of entire South Asia. Raising their concerns, the civil society groups and NGOs like Greenpeace and Coalition for GM Free India have siad that it was the same genetically modified Brinjal which was rejected in India and Philippines. "After the failure of getting this risky Bt Brinjal released in India and Philippines, the GM industry has now turned to Bangladesh. Once the transgenic variety of this vegetable gets clearance in Dhaka, it will automatically enter India illegally through porous border", said Rajesh Krishnan, co-convenor of the Coalition for GM Free India. The activists have asked the government of India that it must take adequate measures under the Article 25 of the Cartagena Protocol on Biosafety to stop any such trans-boundary movement of the GM crop in the eventual case of Bt Brinjal cultivation in Bangladesh. The Convention on Biological Diversity (CBD) to which both India and Bangladesh are parties to, recommends that all measures should be put in place to protect centres of origin and diversity of crops. The Cartegena Protocol on Biosafety, an instrument of the CBD, was specifically created for safeguarding biodiversity, including human health, from either intentional or unintentional trans-boundary movement of living modified organisms. ]]> <![CDATA[Clinical Trials: Realities and myths]]> https://biospectrumindia.com/news/95/8442/clinical-trials-realities-and-myths.html https://biospectrumindia.com/news/95/8442/clinical-trials-realities-and-myths.html Thu, 31 Oct 2013 15:04:00 +0530 The conference on the first day hosted a session titled, 'Myths and Realities - How Patients Benefit from Vaccine Trials', which was presented by Dr Temsunaro Rongsen Chandola, Research Scientist, Centre for Health Research & Development, Society for Applied Studies, New Delhi. In her presentation, Ms Chandola emphasized that the biggest challenge faced today by the research community is earning the trust of the public. She said, "We need to gain the public trust by building an enterprise of trust by encouraging the community that we are working with, and create a network of stakeholders community and get the dialogue going with them. This communication must be transparent and coherent between the stakeholders. Once that's in place, we need to conduct the trials, and walk-the-talk while conducting the trials." To successfully conduct clinical trials, Ms Chandola feels that, first, the right community has to be identified and accessed. "After gaining their confidence," she said, "we need to get to know the community and interact with local leaders, physicians and have adequate data on the disease burdens that you want to study." She further added, "It is imperative to understand the socio-cultural context of the study population, what they do for a living, their geographic location and immunization centers, and the distance between their health facilities, and conduct formative research activities before you start a trial." Dr Chandola also spoke about the significance of creating a community support while conducting clinical trials. She expressed, "We must educate the population in this regard. Just because they don't have college degrees doesn't mean they don't understand." "We need to be consistently and readily be accessible to the communities. This system will work since it is transparent, thereby gaining the communities confidence. Accessibility has to be centered around the subjects and their families and never be compromised throughout the study," she explained. To build an enterprise of trust, Ms Chandola said that the pillars of ethics and competence has to be inculcated. She said, "Don't ever take shortcuts. It will eventually slow things down and it is not worth it. The best of clinical studies lay on the foundation of ethics and good clinical practices (GCP)." Dr Chandola culminated her presentation by saying, "Communication must be open, honest, timely and very clear. Good clinical practices without values is heartless. Value for the patients life and safety matters a lot at the end." Ms Chandola also presented the ROTAVAC Phase III clinical trial case study in her presentation. ]]> <![CDATA[World's first 'Fingerpick Heart Check Device' launched in India ]]> https://biospectrumindia.com/news/95/7225/worlds-first-fingerpick-heart-check-device-launched-in-india-.html https://biospectrumindia.com/news/95/7225/worlds-first-fingerpick-heart-check-device-launched-in-india-.html Tue, 29 Oct 2013 16:58:16 +0530 Alere India launched its world's first and only fingerpick BNP test device named as AlereTM Heart Check System at 2nd World Summit on Echocardiography held recently in New Delhi. According to Mr Sanjeev Johar, CEO - Alere India, "Heart failure is a complex, chronic condition associated with high mortality, multiple comorbidities, and frequent hospitalizations. It can significantly diminish quality of life, and more than 50% of people living with heart failure die within 4 years of being diagnosed. As a market leader in primary care provider, Alere offers the first line of defense in the battle against heart failure. Early detection can lead to early treatment. With the Alere Heart Check, you can accurately identify heart failure within minutes in your office and have a profound impact on your patients' health and prevent hospitalization and any further financial burden." With the accurate, easy-to-use approach, the detection can take place in minutes- right in the clinician's office where a simple blood test will rule out heart diseases. The test is intended to be used as an aid in the diagnosis of congestive heart failure (also referred to as heart failure). It is beneficial in the assessment of severity of congestive heart failure (also referred to as heart failure). It is also important for the risk stratification of patients with acute coronary syndromes. For the risk stratification of patients with heart failure. The AlereTM Heart Check System enables one to make timely decisions that could help initiate heart failure treatment sooner; prevent hospitalizations for your patients and the associated costs; Identify practice efficiencies that will allow you and your staff to focus on those patients who need your care most. ]]> <![CDATA[Pluralistic health approach seems ideal and affordable: Santosh Chowdhary]]> https://biospectrumindia.com/news/95/6307/pluralistic-health-approach-seems-ideal-and-affordable-santosh-chowdhary.html https://biospectrumindia.com/news/95/6307/pluralistic-health-approach-seems-ideal-and-affordable-santosh-chowdhary.html Tue, 29 Oct 2013 16:46:21 +0530 The minister of state for health and family welfare, Mrs Santosh Chowdhary, attended WHO high-level meeting on the implementation of WHO traditional medicine strategy: 2014-2023 at Macau SAR, China on October 28, 2013. Mrs Chowdhary shared India's perspective at the meeting and mentioned that relevance of traditional medicine today is talked about almost at every health forum because the world is facing dual spectrum of health problems, intractable lifestyle diseases and a wide gamut of geriatric health conditions. She said that effective solutions for these kinds of diseases are not found in modern medicine. So, Pluralistic health approach seems ideal and affordable. Therefore governments must adopt multi-dimensional and broad-based policies and strategies to accommodate traditional medicine in the development of health infrastructure and services, she noted. Speaking about the previous WHO Traditional Medicine Strategy 2002-2005 the minister said that it addressed the issues of policy, safety, efficacy, quality, access and rational use of traditional, complementary and alternative medicine. Appreciating the efforts of the member states she said that the number of member states having a formal traditional medicine policy has increased from 25 in 1999 to 69 in 2012; the number of member states that have developed regulations on herbal medicines has increased from 65 in 1999 to 119 in 2012. However, India had enunciated the National Policy on Indian Systems of Medicine and Homeopathy way back in 2002 itself coincidently when global strategy on traditional medicine was framed by WHO. The minister highlighted that India has a pluralistic healthcare delivery system where the government provides opportunity to every recognized medical system to develop and be practiced. Ayurveda, Yoga & Naturopathy, Unani, Siddha, Sowa- Rigpa and Homoeopathy (AYUSH) are recognized systems of traditional medicine in India and they have been integrated into the national health delivery system. There is a peaceful co-existence of Allopathy with AYUSH systems. She said that there is a separate department in our Ministry of Health called Department of AYUSH which provides focused attention for the development and promotion of AYUSH systems at national and international levels. The minister said that during the last 7years, as many as 15,350 AYUSH facilities have been set up in Primary Health Centers, Community Health Centers and District Hospitals and 12022 AYUSH practitioners and 4905 AYUSH paramedical workers inducted into the Government healthcare services. A policy thrust has been given for functional integration of AYUSH in the initiative of Universal Health Coverage (UHC) and national health programmes. She quoted that a survey conducted by National Health Systems Resource Centre (NHSRC) in the year 2008 in 18 States of the country found that AYUSH dispensaries provided services to 20 to 120 patients per facility per day and 80-100 % of the households reported use of AYUSH- based local health traditions. Mrs Chowdhary said that India has developed a vast infrastructure of AYUSH facilities comprising of 7,20,937 Registered practitioners, 24,392 Dispensaries & 3,195 Hospitals in public sector, 508 Undergraduate Colleges with annual intake of 25,586 students, 117 centers for Post Graduate education with annual admission of 2,493 scholars and 8,785 licensed drug manufacturing units. The Government has supported resource augmentation in 38,954 hectares in forest areas for medicinal plants & support for cultivation of medicinal plants in 1,85,719 hectares of land has been provided to the farmers till September 2013, she added. Speaking about the National AYUSH Mission the Minister said that it aims to provide complete functional integration in the Essential Health Package and help in combating under-nutrition in children, reduction of anemia in women and prevention and reduction of burden of Communicable and Non-Communicable diseases (including mental illnesses). Mrs Chowdhary emphasized that India has developed Traditional Knowledge Digital Library (TKDL) for protecting traditional knowledge against misappropriation and wrong patents. Under TKDL, digitization of the knowledge available in public domain in the form of existing literature related to Ayurveda, Unani, Siddha and Yoga, is being done in patent compatible format in five International languages English, German, French, Japanese and Spanish. Till September, 2013 a total of 2, 90,998 formulations have been transcribed, she said. The minister noted that foreign nationals have been encouraged to come to India for studying Ayurveda. Quality of education, practice, research and drug manufacturing have been regulated and enforced with similar provisions which are stipulated for modern medicine. Smt. Chowdhary hoped that the implementation of the new strategy will be the turning point for the countries in mitigating health challenges with systematic utilization of traditional medicine and it would lead us to new era of Universal Health Coverage. Present at the occasion were Dr. Margaret Chan, Director General, World Health Organization, Mr Fernando Chiu, CEO Macau, Health Ministers of different Countries, officers and experts of WHO and various other dignitaries. ]]> <![CDATA[â€œYearning for attention!â€? ]]> https://biospectrumindia.com/news/95/6335/yearning-for-attention-.html https://biospectrumindia.com/news/95/6335/yearning-for-attention-.html Mon, 28 Oct 2013 18:14:00 +0530 Meanwhile, catching up latest global trends, the technologies in India too are fast moving from labs to the patient's bedside. BioSpectrum tries to find out the latest in this segment. Access to quality healthcare in India needs to be expanded, and that is not possible without increasing access to medical technology which is a crucial pillar in the healthcare sector. Broadly categorized into two categories, capital equipment, and implantables or what few may call consumables, India's close to $3 billion strong medical devices market is growing at a rate of 15 percent per annum, promising immense potential. As healthcare is also a top priority for government, the industry has also been making many efforts to better explain the medical devices industry and the value of medical technology to patients and the population in general. We are different please! Industry insiders feel that with regards to pricing and reimbursement, there is a need to treat medical devices separately. "Compared to pharmaceuticals, medical devices (that include invitro diagnostics) are an extremely diverse group of products. Some are as simple as adhesive bandages, tongue depressors, and plastic tubing. Others are complex, for example, implanted cardiac, cardiovascular, and neurological devices, stair-walking wheelchairs, robotic surgical systems, and magnetic resonance imaging devices, opinions Ms Abby Pratt, associate vice president, Global Strategy & Analysis, AdvaMed, "In contrast to single-molecule drugs, many complex devices involve a number of components that, together, form a system. Given the diversity and complexity of medical devices as compared to pharmaceuticals, outcomes of the use of medical devices often depend directly on the skill or experience of the user." Another point that is highlighted by experts is in terms of the industry composition, over 80% of the medical devices industry is comprised of small and medium sized companies (SMEs) whereas the pharmaceutical industry is dominated by a few very large multinationals.The active components of medical devices are generally based on mechanical, electrical, and materials engineering. Many medical devices incorporate and are driven by software. In contrast, pharmaceuticals are based on pharmacology and chemistry, and increasingly encompass biotechnology and genetic engineering. In recognition of these dramatic differences, pharmaceuticals and medical devices are regulated separately in all major markets across the world. Medical devices typically have a short product life cycle, about 18 to 24 months, and investment recovery period. Market competition from similar devices is often intense, even in the early stages of a new technology. In contrast, pharmaceuticals typically have a long commercial life-cycle (10-20+ years), during which they do not undergo significant changes. Therefore, pharmaceuticals require intensive patent protection including data exclusively due to the extensive product life cycle and long investment recovery period. Says Gautam Khanna, executive director, Health Care Business, 3M India, "Drugs and devices need to be considered separately also in terms of their product lifecycle. In the pharmaceutical world, companies undertake extensive research and development of a specific compound or molecule. It typically takes several years for a new drug to enter the pipeline. Medical devices in contrast are developed through continuous innovation and iterative improvements based on new clinical practices, new science, new technology and new materials." Due to the wide variety of structures and technologies embodied in medical devices, many different patents typically cover a single medical device. For example, a pacemaker will typically have separate patents (often several) covering the housing, battery, capacitor, electrical circuit, communication system, software programs for therapy delivery, sensing and detection, lead structure, and electrical system (electrodes and sensors) on the lead. By comparison, there are typically very few patents for individual pharmaceutical products. Since there are a finite number of molecules that may be used to elicit a desired biological response and clinical outcome, competitors may be effectively excluded from making the pharmaceutical product by a single patent covering the class of molecules that comprise the pharmaceutical product. Once the patent expires, or is no longer applicable, it is possible for competitors to produce "generic" versions. Therefore, unlike pharmaceuticals, the basis for competition in the medical device field is generally not patents and patents generally do not confer market exclusivity as they do for medicines. Plugging policy loopholes Another aspect where we need to differentiate between drugs and devices are in the rules for clinical trials. The way drugs and devices affect your body are very different. For instance, drugs get assimilated into the blood stream and can have an impact on your entire body, which means that in case of adverse reactions they can have damaging effects on multiple parts. On the other hand, devices interact with body parts in a limited way - for instance, stents with the heart and knee implants with the knee. So they have a very limited negative impact in case of adverse reactions during trials. The industry over the years has been making efforts to introduce separate and appropriate regulations for medical devices. The new Drugs and Cosmetics Amendment Bill will hopefully bring right differentiation between drug and device. Says Ms Abby Pratt, "As policy goes through a lifecycle of regulations, it is important to differentiate between rules made for drugs and rules made for devices at every stage and these regulations should be harmonized with global regulations so that we get best of class devices available in India without hassle. According to Gautam Khanna, the guidance documents developed by the global harmonization task force (now the IMDRF) would be an excellent starting point for India's new regulatory regime for medical devices. Gautam explains, "In 2011 India was invited to join the International Medical Device Regulators Forum (IMDRF). This would be a huge opportunity for the India Govt to work with foreign regulators side by side towards a harmonized system for medical devices regulations that benefit India's patients by improving the quality of India's device regulations, enhance the environment for innovation and benefit regulators who would be able to exchange views with regulators across the world." Sanjeev Johar, CEO, Alere India opines that the though Indian regulators understand the need and they are not properly staffed to carry out their tasks. Under the circumstances, he says that it would be best for them to remain abreast on devices and the trends in Europe and US. "Normal tendency should be not be that this imported technology is new and now we therefore can't allow it due to unawareness. That would be unfortunate. So it is advisable for them to remain aware on such new technologies and innovations," he says. Market unpredictable though future bright Despite the small market size, the industry is growing at strong pace. The reports suggest that in next 3-5 years, this industry is expected to go upto $ 4-5 billion. Abby Pratt feels that the unpredictability of the market leads companies to be cautious about investing in and expanding into this market. "The trajectory of the new regulations as well as pricing and reimbursement policies will likely affect how companies judge the attractiveness of the India market," she says. Amitabh Roy Chowdhury, executive director and COO of Prisma Global is of the opinion that the technology is making healthcare more accessible and popular. He mentions, "We also need to spread awareness about the benefits of medical technology. Exploring public private partnership solutions can further strengthen healthcare access and tap into the potential of the sector." Traditionally India has been focused on laboratory research. But latest trends point towards the fact that the technology will move out of the lab and get closer to point of care. There is an overall consensus that much attention is needed for the smarter devices that are closer to patients and help in early prevention and treatment. The policymakers, regulators and industry stakeholders will have to engage in repeated discussions over the period of time to ensure the clear roadmap for the segment. ]]> <![CDATA[Venus Remedies steps into Latin America with Elores, its flagship product]]> https://biospectrumindia.com/news/95/8169/venus-remedies-steps-into-latin-america-with-elores-its-flagship-product.html https://biospectrumindia.com/news/95/8169/venus-remedies-steps-into-latin-america-with-elores-its-flagship-product.html Mon, 28 Oct 2013 17:52:23 +0530 Venus Remedies Limited, a leading research-based global pharmaceutical company, has made inroads into Latin America with its patent-protected novel antibiotic adjuvant entity, Elores, securing marketing authorisation from Guatemala, where the product will be launched early next year. Hailing the development, Dheeraj Aggarwal, Chief Financial Officer, Venus Remedies Limited, said, "This is the first marketing authorisation for Elores from a Latin American country. It will prove to be our ticket to Latin America by enabling us to expand our research product kitty there. Cashing in on this tremendous opportunity, we expect to generate a revenue of US $5 million within three years of the launch. Keeping the rapid emergence of resistant microbes in mind, our product is the need of the hour in Latin American countries at this juncture." Aggarwal said that ever since Venus Remedies launched Elores in the Indian markets in January this year, the product had been receiving a tremendous response from the medical fraternity across the nation. The prevalence of antibiotic resistance is among the highest in Latin America, a US $50 billion pharmaceutical market growing at a compound annual growth rate of 15-20%. Resistance to Extended Spectrum Beta-Lactamase (ESBL), an enzyme released by resistant bacteria that deactivates antibiotics, is found to be as high as 40-60% in Latin American countries. Dr Manu Chaudhary, Joint Managing Director, Venus Remedies and Director (Research and Regulatory), Venus Medicine Research Centre, said the registration of Elores in Guatemala had been processed in a record time of less than six months. "Elores is included in the list of Qualified Infectious Disease Products (QIDPs) under the Generating Antibiotic Incentives Now (GAIN) Act, which was incorporated in the US Food and Drug Administration (FDA) Safety and Innovation Act. The Act provides added exclusivity to antibiotics and earmarks antibiotics for priority review. This has enabled our products like Elores to secure market exclusivity for five years as well as a fast-track review," said Dr Chaudhary. Elores, the flagship product of Venus Remedies, is known for its efficacy against serious multidrug-resistant hospital-acquired infections involving metallo-beta-lactamase and carbapenem-resistant strains of bacteria such as E. coli, K. pneumoniae, P. aeruginosa and A. baumanni. Infections caused by resistant microorganisms are failing to respond to conventional treatment, thereby resulting in prolonged illness and greater risk of death. Elores has a unique profile of action, which gives it an edge over all the existing therapies. The product has recorded a significant reduction in treatment time and cost by up to 30%. It prevents both development and spread of bacterial resistance from one species to another, which makes it one of the safest drugs available to cater to multidrug-resistant carbapenem-resistant enterobacteriaceae (CREs). Elores was recently awarded a gold medal and named the "No. 1 Innovation of the Year 2013" by a team of experts from Stanford Business School, US, IC2 University of Texas, Austin, US and Lockheed Martin Foundation in collaboration with the Department of Science and Technology, Government of India, under the Indo-US joint science and technology innovation programme. The team has selected Elores among the top eight technologies to be commercialised in the US soon. Elores has received patent protection from 48 countries. Its registration process is underway in 23 countries, including Europe (13), Gulf Cooperation Council (GCC), Middle East and North Africa (MENA) and Asia. ]]> <![CDATA[Wockhardt declared results for quarter 2 for the year 2014]]> https://biospectrumindia.com/reports-white-papers/95/5185/wockhardt-declared-results-for-quarter-2-for-the-year-2014.html https://biospectrumindia.com/reports-white-papers/95/5185/wockhardt-declared-results-for-quarter-2-for-the-year-2014.html Mon, 28 Oct 2013 17:14:00 +0530 Wockhardt Limited, the Pharmaceutical and Biotechnology major, reported its 2nd and 1st half results for Financial Year 2014. Commenting on the results the Mananging Director of Wockhardt, Dr. Murtuza Khorakiwala said "The current performance has been impacted due to the recent reguklatory actions, however Team Wockhardt is commited to raise the bar across all functions and revert with better performance in all areas of operations at the earliest." The key points of the result announced includes: - Consolidated revenue for the quarter was Rs. 1197 crore and Profit After Tax was at Rs 138 crore which represents 11.5% of Profit After Tax Margins. - The company increased its Research spend significantly and the same is now at 8.9% to sales at Rs 106 crores and including capital expenditure is at 10.2% to sales for the quarter. - Wockhardt filed 3 new product applications with USFDA during the quarter. Cummulative products pending approval with USFDA stands at 53 as on September 2013. - Research expenses stood at Rs. 204 crores for the 1st half representing 8% of sales and including capital expenditure is at 8.8% of sales. - Wockhardt filed 7 new product applications with USFDA during the ist half year. Launched 13 new products in India in Q2FY14 introduced 2 new divisions in India. Uk received 3 approvals and launched 1 product during the quarter. - Wockhardt's International Business contributed 78% of the Total Revenues during the quarter. - Wockhardt's US business declined by 19% in Q2FY14 and by 4% in 1st half of FY14 and contributed 44% of the Global Revenues for Wockhardt in Q2FY14 and 49% in 1st half of FY14. - The UK business recorded a growth of 5% in Q2FY14 and 3% in 1st half of FY14. - The India business declined by 2% in Q2FY14 and grew by 1% in 1st half of Fy14, while the emerging markets business declined by 21% in Q2FY14 and by 24% in 1st half of FY14. ]]> <![CDATA[Biocon ranked 6th in top twenty biopharma employers list]]> https://biospectrumindia.com/news/95/4946/biocon-ranked-6th-in-top-twenty-biopharma-employers-list.html https://biospectrumindia.com/news/95/4946/biocon-ranked-6th-in-top-twenty-biopharma-employers-list.html Sun, 27 Oct 2013 22:29:00 +0530 Speaking on the occasion at Biocon's press meet, Ms Kiran Mazumdar-Shaw, Chairman & Managing Director, Biocon, said, "This rating has been done on various attributes based on research quality, clear vision and social responsibility. We are the only Indian and Asian company to make it to this list. Globally, that's a big recognition for what Biocon stands for today." The event was also attended by Mr Peter Bains, Director, Syngene International, along with Biocon's key management team including Dr Arun Chandavarkar, Mr Murali Krishnan, Dr Abhijit Barve and Mr Rakesh Bamzai. Dr Kiran also declared Biocon's earnings for the first half of the fiscal year during the event. She added, "Our biopharmaceuticals sector has grown significantly through our immuno-suppressants and Insulin products. It is gaining a lot of momentum in the emerging markets. Our research services has been a stellar performer in revenues, which has grown 46% in the quarter and 36% at the half year level." Talking about ALZUMAb's launch in August 2013, Ms Shaw said, "ALZUMAb is not just a first-in-class drug, but also a potential best-in-class. We are very encouraged by its early acceptance in the Indian market. Only time will unravel how powerful the drug is." Dr Kiran also added that diseases like multiple sclerosis will provide Biocon with a big opportunity for research, along with Vitiligo, for which it will conduct clinical trials in India. Commenting on Biocon's performance amidst various challenges, she opined, "The last two quarters were challenging for the entire Indian pharma sector because of issues in drug regulations, trade, price control, and other disputes. This has actually hit every single pharma company, and Biocon was not spared either. So we've seen 12% growth in the H1 FY14." Ms Shaw said that Biocon now is the #1 Indian Insulin company, and also gaining visibility as the 4th largest globally. She said, "We are seeing a strong growth of our Insulin business worldwide. We are doing our best to maximize the supplies of our Insulin from India, until the opening of our Malaysian facility." Currently Biocon's Asia's largest integrated Insulin manufacturing facility is coming up at Johor, Malaysia, which according to the company will address the increasing Insulin demands from emerging and global markets. Responding to a question posed by BioSpectrum India in this regard, Dr Kiran responded, "The manufacturing plant facility is coming up on track. It'll be ready to operationalize by FY15. Currently we've issues with demand. The new Malaysian facility will help us mitigate this." Dr Kiran expressed that India is becoming an unattractive place for clinical trials in the area of drug innovation. She said, "If India doesn't become a responsible country in terms of clinical development, then we can't expect new drugs to come out of India. It has to be developed elsewhere and we can't take the credit for doing it in India." "If drugs have to be developed in India, then Indian patients need to be trialed, making sure that this is understood well in the Indian patient environment and other parts of the world," she explained. Dr Kiran further added on the role of media and judiciary in the area of clinical trials. "Every country recognizes the importance of trials and India should play a role. Activism should not overtake science and evidence-based medicine. It is important for our judiciary to understand the importance of clinical developments for a country like India. The judiciary mainly seems to be hearing only one side of the story." While speaking on Syngene's performance, Dr Kiran added, "Syngene is a partner of choice in this part of the world, differentiating it as an innovative research provider, making it a clear market leader. However, Syngene, this quarter, has taken a hit, but still it has achieved growth. Clinigene too is on track with modest growth." Ms Shaw concluded by talking about the company's future outlook. "Looking ahead, we are certainly focusing on innovation-led programs and making ALZUMAb a big success globally. Our outlook for the rest of the year remains positive, and we will continue with our R&D investments, delivering another stellar set of numbers for the next two quarters and beyond," she expressed. ]]> <![CDATA[DIA's 8th Annual Conference kicks-off in Bangalore]]> https://biospectrumindia.com/news/95/3479/dias-8th-annual-conference-kicks-off-in-bangalore.html https://biospectrumindia.com/news/95/3479/dias-8th-annual-conference-kicks-off-in-bangalore.html Fri, 25 Oct 2013 19:57:00 +0530 Themed, 'The New Clinical Research Environment in India: Implications and Opportunities', the event was graced by eminent guests from the industry including, Padmashree Prof Ranjit Roy Chaudhury, Chairman, Task Force for Research, Apollo Hospitals Group and Ms Anu Acharya, CEO, mapmygenome.in, who were also the keynote speakers. The program chairs were held by Mr Shoibal Mukherjee, VP, CMO (India) & Head Asia Medical Sciences Group, Quintiles, and Mr Sairamkumar J, Sr VP & Global Delivery Head, Cognizant Life Sciences. The guest of honor, Mr M Madan Gopal, IAS, Principal Secretary to Government of Karnataka, Health and Family Welfare Department, addressed the gathering based on its theme. Mr Madan Gopal said, â€œWe are struggling very much in infant & mother mortality and public healthcare issues. Healthcare will play a significant role in combating it. Research in the basic sciences is on the decline in the country. We need to focus on basic science research which is the foundation for the healthcare industry.â€? He felt that basic sciences no longer attract people as it requires commitment and passion. â€œHowever, in countries like US and Europe, a lot of focus is given to basic sciences, which lays the foundation for science and technological developments,â€? he added. Mr Gopal also expressed that India is grappling with healthcare issues in the areas of affordability, accessibility and quality. Mr Shoibal Mukherjee in his speech said that clinical research is important for India, as the country has major disease burdens. â€œWe need to go beyond our model and look at countries like Sri Lanka, Nepal, and South-east Asia." Commenting on the sensitive issue of clinical trials, Mr Gopal said, â€œWhile conducting clinical trials, ethics should not be overlooked. The Supreme Court has expressed its concern stating that people in India are subjected to clinical trials which cannot be carried out in any other civilized country. People under clinical trials need to be protected. If this is taken care, we can witness remendous growth in clinical research.â€? Mr Sairamkumar expressed that India is passing through an exciting time in the areas of pharmaceutical and clinical research. He said that India has a great potential for clinical research. "We have many problems to overcome but we have to seize the opportunities," he said. Mr Gopal addressed the dramatic changes taking place in the discovery of new drugs. â€œToday the processes have become very systematic. Both, identification and modification of chemical structures to achieve specific results in biologics is now a complex process. Today, IT-based process technologies is on the rise,â€? he added. Talking about diagnostic counseling, Mr Gopal said that India lacks much in the area of diagnostic counseling. He opined, â€œCounseling during pre-diagnostic and post-diagnostic stage will improve the confidence levels of patients and their families.â€? Mr Gopal culminated his speech by admonishing the participants by asking them to come up with discussions and solutions in specific relation to clinical research. ]]> <![CDATA['Robust growth in next three years' : Mr Surendra Kumar Agarwal]]> https://biospectrumindia.com/interviews/95/6998/robust-growth-in-next-three-years-mr-surendra-kumar-agarwal.html https://biospectrumindia.com/interviews/95/6998/robust-growth-in-next-three-years-mr-surendra-kumar-agarwal.html Fri, 25 Oct 2013 18:38:00 +0530 Into the business since 1976, Sisco Research Laboratories (SRL) is a pioneering manufacturer of molecular biology grade specialty chemicals. SRL has been at the forefront of identifying, manufacturing and supplying new compounds and ready-to-use reagents for biochemists and molecular biologists world over. Mr Surendra Kumar Agarwal, managing director, SRL shares his views on the buying behavior of clients, recent product additions, and growth. What is the potential for your market in India compared to that a decade back? Have you noticed any change in the buying behavior of clients? Mr Agarwal: When we talk about the market behavior today we see wider acceptance for Indian products as compared to 10 years back or so when there was lack of confidence from the buyers. Perception has changed. Market has become favorable for business. We see lot more new chemical entities now and the private CROs are also doing chemical research. Buyers have become demanding and manufacturing of specialty reagents market has changed. The industrial revolution that is currently going on in India, especially healthcare, is drifting towards more closely documented and regulated manufacturing practices, putting tremendous expectations on biosuppliers to commit and fulfill regulatory requirements. SRL's indegenous manufacturing and traceability standards are geared towards satisfying all such requirements. In the next five years, these norms are only going to get stricter and necessitate very strong infrastructure and back-end processing by biosuppliers in order to remain partners to the actual biopharmaceuticals industry. Regulatory changes, penetration in smaller companies, and standards have made the biosupplier market more competitive. What is your current market share? Have there been any major additions into your product portfolio? India is a fragmented market; there are only about 10 major companies in India in this market. We have about 25 percent market share in biochemicals and bioreagents. We have seen tremendous growth especially in bioorganic market. We are into manufacturing of biocatalyst. There have been additions in our product portfolio. Our molecular biology grade solvents, are DNAse, RNAse and Protease free and also free from other volatile organic impurities, that may arise while dissolving samples of proteins/amino acids and any other biological samples while performing assays. SRL has developed proprietary technologies to enhance these solvents which are used widely and have eliminated the use of regular lower grade solvent systems. Our recent introductions are DNA and protein tools which are used as biotechnology markers and in genomics. Added range of growth factors also adds to the list. Also we have additional list in protein enzymes. Q. How has the advancement in technology helped your business evolve? We invest heavily in new equipments. Bigger companies like Merck Millipore and all are setting the standards. We are the suppliers of it. We are adopting technology to make it more economical to customers. Advancement in the technology is making a difference. We are marching ahead with technology as our key driver for future growth. Has the increased research funding in India helped in expansion of your business? What is the future outlook for your company? Increase in research funding has definitely helped us to expand our business. Almost 40-50 percent of our business is from government research funding. We are diversifying our business in pharmaceutical. Apart from this we have a large share of market in Malaysia and Middle- East. We are major suppliers of product to Research and Development (R&D) sectors. Africa is our second largest market for R&D business. We have seen a slow down this year, however next three years seem to be robust for us. We are eyeing for continuous growth with few acquisition in the coming few years. We are expanding our production capabilities as well. What are the expectations this year in terms of revenue and growth? We are looking forward for 19-21 percent growth this year owing to about 400 products that we have launched. The launch of the products is simply because of growth of clients. We have seen no decline in the production of our clients. We have installed good information technology. Summing the impact of all this we can achieve the expected growth rate by the end of 2013. Any new recent innovation put into practice by your company? Since our inception, we are majorly into molecular biology and lot of innovation if put into practice in that area. The major innovation put into practice is adopting the greener technology and as a result of this, we have manufactured noncarcinogenic molecules. Eco-friendly reagents have been showing a steady growth with respect to customer adoption and perception. It is a growing mandate through-out the scientific community to adopt safer lab handling practices and our new-product research team is specially focusing on the manufacturing of such products as a part of our offerings to customers. We have developed non-toxic environment friendly solvents (Ionic Liquids) which are used in bio-applications such as medicinal chemistry and synthetic chemistry. Along with this, we are manufacturing eco-friendly marker dyes such as BioLit SafeDye Stain (a trademarked SRL product) which eliminates the use of similar carcinogenic generics used by researchers today. ]]> <![CDATA[ Diversity of the Indian market is quite unique and challenging]]> https://biospectrumindia.com/interviews/95/6078/-diversity-of-the-indian-market-is-quite-unique-and-challenging.html https://biospectrumindia.com/interviews/95/6078/-diversity-of-the-indian-market-is-quite-unique-and-challenging.html Fri, 25 Oct 2013 18:18:16 +0530 Can you explain the overall market scenario of medical diagnostics in India? Mr Richard Guest: As per a recent study by Price water house Coopers, medical device industry including In-Vitro Diagnostics (IVD) and radiology is worth more than $4 billion, growing at a CAGR of 15 percent. But this can only be an estimate, since healthcare is probably one of the most challenging industries to accurately forecast. Growth depends on several factors like urbanization, government spending, and exchange rate. The IVD industry in India is still in its early stages, yet, it is quickly expanding. The current market is experiencing steady double digit growth and once a highly-fragmented competitive IVD manufacturer landscape continues to consolidate. Additionally, the market is rapidly implementing advanced laboratory automation solutions in the high-end segments. These signs coupled with the fact that healthcare in India is becoming more accessible and affordable to the general population is exciting. With ever changing trends and expansion, what are the latest trends in medical diagnostic market? Medical diagnostics today is all about quality, speed, and accessibility. Talking about quality, years ago, clinical images were pictures of blurry grey; thus they are very difficult to read. 3D-Imaging, functional imaging or visualizing molecular information was unthinkable. Today, we are close to delivering a "digital copy" of the patient, showing structures less than one millimeter in high resolution and 3D. Not only diagnosis but image-guided therapies are also possible today. In terms of speed, our flagship CT scanner SOMATOM Definition Flash performs a heart scan in split second. Finally, accessibility has significantly improved. Today, millions of people in India have access to clinical imaging, which is also a result of more affordable imaging solutions. Additional drivers forcing this upward trend include broader access to healthcare insurance, accreditation, more public-private partnerships, market consolidation and changing disease patterns. India's established clinical laboratories are also beginning to more aggressively elevate their quality standards and maximize productivity of their existing lab footprint. Looking at the potential growth in India, can you elaborate on the opportunities and challenges in medical diagnostic markets? India offers a number of opportunities, along with some challenges, towards further growth of its diagnostics market. The opportunities are clear: a noticeable increase in government healthcare spending, coupled with rising income and education levels, are priming the country for a major influx of diagnostic solutions, made available to a much larger population segment than ever before. Leveraging our strong reputation and installed base across the country, we see opportunities to further expand the range of Siemens solutions and services for our Indian customers, particularly in areas like microbiology, hematology, and point-of-care IVD testing. The diversity of the Indian market is quite unique and challenging. On one hand, you have high-class hospitals and on the other, there is a vast and fast growing market for entry and mid-level products. Siemens tries to serve both markets with innovations that equally cater for quality, effectiveness and price-efficiency. However, obstacles do remain that may limit India's IVD growth potential. They include a volatile healthcare insurance network, fluctuating currency exchange rates, and shifting import rules. How do you visualize the company's strategy on expansion? Siemens Healthcare's global initiative of Agenda 2013 entails objectives like expanding our regional presence in the fast-growing emerging markets and further extending our portfolio of systems in the middle price segment. Agenda 2013 also focuses on driving innovation leadership and people development. With this strategy in place, we will continue to bring M3/M4 innovative products to India. Moreover, our Corporate Technology and Development Center located in Bangalore with its talent pool of over software professionals will continue to play a significant role in R&D. ]]> <![CDATA[New Siemens HIV Combo Assay provides quick and reliable results ]]> https://biospectrumindia.com/news/95/8115/new-siemens-hiv-combo-assay-provides-quick-and-reliable-results-.html https://biospectrumindia.com/news/95/8115/new-siemens-hiv-combo-assay-provides-quick-and-reliable-results-.html Fri, 25 Oct 2013 17:10:58 +0530 The Siemens Healthcare Enzygnost HIV Integral 4 assay 1, an HIV test mainly intended for use in blood banks or laboratories, delivers accurate results quickly and reliably, enabling clinicians to identify HIV infection earlier and improve patient care. This new assay is an HIV combination test (or HIV Combo test), a type of assay that detects both the HIV p24 antigen and HIV antibodies, and is increasingly becoming the standard screening technique used by healthcare authorities in many countries within the European Union. The development of the new HIV assay demonstrates the company's innovative power, one of the goals of Siemens Healthcare Initiative 'Agenda 2013'."The increased sensitivity of the HIV Integral 4 assay enables treatment earlier, and its high specificity provides our blood bank customers with confidence that the results are precise, enhancing the accuracy of their donor screening programs" commented Mr Stefan Wolf, CEO, Hemostasis Hematology and Specialty Business Unit, Siemens Healthcare, Diagnostics Division. The Enzygnost HIV Integral 4 assay delivers both excellent specificity and sensitivity. In a study of 14,169 donor samples tested at three different blood banks, initial specificity was demonstrated at 99.94%. Data also show that the HIV Integral Assay has higher sensitivity and provides superior seroconversion performance (quicker prevalence of the antibody) compared to other currently available assays, detecting HIV infection up to 14days earlier. ]]> <![CDATA[Sustaining Momentum in biopharma & research services, Biocon delivers 19 % growth]]> https://biospectrumindia.com/reports-white-papers/95/7640/sustaining-momentum-in-biopharma-research-services-biocon-delivers-19-growth.html https://biospectrumindia.com/reports-white-papers/95/7640/sustaining-momentum-in-biopharma-research-services-biocon-delivers-19-growth.html Fri, 25 Oct 2013 17:07:01 +0530 The biosimilars portfolio saw a robust growth in H1FY14, driven by the growing demand for generic insulins from emerging markets. We continue to enhance our emerging market footprint to provide a wider access to affordable insulin therapy top diabetics worldwide. We have successfully completed the India Phase III trial for biosimilar trastuzumab and have filed for regulatory approval with the Indian authorities. The other programs in the biosimilar development portfolio continue to progress well, and we look forward to bringing them further along the clinical development pathway. The branded formulations vertical grew at 9% YoY this quarter, vis-a-vis the industry growth of 3%. We have sustained challenges in the Indian Pharma market (IPM), which de-grew by 2% in September '13. Systemic hurdles led by the chaotic implementation of the recent NPPA guidelines and the trade disputes on margins have resulted in widespread de-stocking and reduced off take. The highlight for us in Q2 FY14 was the launch of Alzumab (Itolizumab), a 'First-in-class' novel biologic therapy for Psoriasis. With a differentiated mechanism of action, Alzumab offers a new treatment paradigm for Psoriasis patients with a less aggressive dosing regimen and longer treatment free period. The product has been rolled out across the nation, and we have seen encouraging feedback from dermatologists and patients alike. Commenting on the results, Chairman and Managing Director, Kiran Mazumdar Shaw stated "Biocon has witnessed a strong performance in the first half of FY14 driven by an increased traction in emerging markets. Immune-suppressants and Insulin continue to drive growth. This is in part bolstered by capacity expansion of our insulin plant. Our biosimilar pipline partnered with Mylan, continues to progress well and we anticipate Indian regulatory approval for our biosimilar Trastuzumab in the near future. The research services vertical has delivered a stellar set of numbers =, despite an exceptional forex loss in Q2 FY 14. The branded formulations business has grown ahead of the market but has been muted by business and regulatory challenges. We remain confident that growth will continue across all businesses" The research services segment grew 25% YoY and 30% YoY at Constant Exchange Rate (CER) for H1 FY14 and Q2 FY14 respectively, with widespread growth across our service platforms. Commenting on this performance, Peter Bains, Director Syngene International, said "The strong performance of research services in H1FY14 reflects the underlying strength of our diversified service offerings, which span the discovery and development continuum. This growth has been driven by a strong momentum in our manufacturing services platform along with a ramp up in our FTE contracts. Our continuous investments in capacities and capabilities have helped us enhance our end to end discovery, developments and manufacturing offerings, in line with our clients evolving requirements. We expect the current business momentum to continue supported by incremental investments, leading to a strong performance this fiscal." ]]> <![CDATA[Quintiles named as one of the World's Best Multinational Workplaces ]]> https://biospectrumindia.com/news/95/6879/quintiles-named-as-one-of-the-worlds-best-multinational-workplaces-.html https://biospectrumindia.com/news/95/6879/quintiles-named-as-one-of-the-worlds-best-multinational-workplaces-.html Thu, 24 Oct 2013 17:50:14 +0530 After receiving nine individual Great Place to Work awards in 2013, Quintiles has again been recongnized as one of the World's Best Multinational Workplaces by Great Place to Work, ranking 18th on the 2013 list. This ranking is the world's largets annual study of workplace excellence and identifies the top-25 best multinationals in terms of workplaceculture. Quintiles has been named to the Best Multinational Workplace list in each of the ranking's three years existence. Quintiles received individual Great Place to Work awards in 2013 for its operations in Canada, Germany, Ireland, Italy, Mexico, the Netherlands, Scotland, Spain and the United Kingdom. "We are honored to be among the top -25 multinational workplaces again this year," commented Chief Administrative Officer Mike Mortimer. "As a service provider, the value we bring to our biopharma customers comes directly from our 27,000-plus employees around the world. Creating and maintaining a positive working environment which the best and brightest seek out is a key component of Quintiles ' success." "The companies listed on the third-annual World's Best Multinational Workplace list are creating workplace dedicated to fostering trust, pride and camaraderie amongst their employees," said China Gorman CEO of Great Place to work. "Their inclusion on this prestigious list demonstrates their commitment to continually improving the lives of their employees and setting innovative new standards for the worplace of the future." ]]> <![CDATA[BIRAC's first IGNITE batch had enriching experiences at Cambridge ]]> https://biospectrumindia.com/news/95/7083/biracs-first-ignite-batch-had-enriching-experiences-at-cambridge-.html https://biospectrumindia.com/news/95/7083/biracs-first-ignite-batch-had-enriching-experiences-at-cambridge-.html Thu, 24 Oct 2013 17:40:00 +0530 BIRAC and Centre of Entrepreneurial Learning (CfEL) of Judge Business School, University of Cambridge have initiated a partnership that would enable five BIRAC supported applicants to take part in CfEL's flagship intensive entrepreneurial boot-camp programme called "IGNITE". It is aimed at providing entrepreneurial opportunities to explore their innovative ideas and transform them into a business project. The first batch of five BIRAC supported IGNITE candidates went to Cambridge in July 2013. The five candidates have shared their learning experience with the agency. Among the participants, Neeraj Jasmathiya Medical Device Innovator and Industrial Designer, Stanford India Biodesign mentioned that the programme was very beneficial for him. "The ecosystem around Cambridge was phenomenal and unique both in terms of experience and learning. I wish if such fellowship was for longer duration, however 15 days were cleverly structured so that every bit of it can be fruitful for the fellows arrived from different parts of the world. I feel there is requirement of organising more of such fellowships to develop visionary entrepreneurs in India," elaborates Neeraj. Sharing his experiences, Sahil Kapoor Director - Global Business Operations Novo Informatics, "IGNITE has been most beneficial program for our company. It enabled us to enter scientific and entrepreneur community which gave us new insight of market. One of best experiences were interaction with Investors, Companies to understand what they are looking for? What kind of business models are used? And how companies grew as per fluctuations in global market? I sincerely thank BIRAC for giving me opportunity to experience IGNITE program." Dr Radha Rangarajan Founder and CEO Vitas Pharma said that the IGNITE experience was truly an inspiring one for him. "The course was a mix of formal lectures and discussions in small groups, a format that was ideally suited for learning about the larger themes of running a company as well as addressing the specific needs of the participants. The course was run by business practitioners, who brought their experience to the classroom and took us through topics such as business models, accounting, financial forecasts etc" "It was a unique privilege to see so many successful Biotechnology Entrepreneurs coming together to help nurture entrepreneurial spirit and provide valuable insights to the beginners. I was able to receive an all-round understanding of the process of evolving a "Technology Enterprise" during this week," shared Vishwas D. Joshi, Founder and CEO, Seagull BioSolutions. The final participant, Tuhin Bhowmick Chairman, Pandorum Technologies while sharing his experiences said that the program-aspects which he had found to be particularly beneficial were the group-clinics, regular meetings with the assigned mentor, lecture on the art of negotiation, the pitching sessions and the feedbacks. "Further, following the IGNITE week, the BIRAC-IGNITE fellows had an extended week of pre-decided and self-arranged company visits. The series of interaction with companies located at Cambridge Science Park, Cambridge Research Park and Babraham Incubation Centre were extremely useful in highlighting the need of a strong symbiosis between the academia and industry, for bringing innovations from the 'bench to bedside'," he concluded. ]]> <![CDATA[Poor public infrastructure makes living with multiple sclerosis a struggle for patients]]> https://biospectrumindia.com/news/95/8440/poor-public-infrastructure-makes-living-with-multiple-sclerosis-a-struggle-for-patients.html https://biospectrumindia.com/news/95/8440/poor-public-infrastructure-makes-living-with-multiple-sclerosis-a-struggle-for-patients.html Thu, 24 Oct 2013 17:36:42 +0530 In recent times, a wide range of innovative therapies have become available that can now target the different types of MS. Unfortunately most patients are unable to benefit from this development as they cannot afford these therapies. Also, insurance companies have been reluctant to cover this lifelong disease under medical coverage. Poor public infrastructure adds to the patients misery. The Draft Rights of Persons with the Disabilities Bill 2012, prepared by the Ministry of Social Justice and empowerment recommends including multiple sclerosis amongst others to the standard seven disabilities recognized under the existing Persons with Disabilities (PWD) Act 1995. Once passed, the bill would enable a person living with multiple sclerosis to entitlement of the same legal rights and benefits similar to those living with blindness or loco-motor disabilities. The bill would also protect disabled persons against discrimination, provide affirmative action and penalize and punish offenses committed against them. As per Dr B S Singhal, Director, Department of Neurology, Bombay Hospital, Mumbai, "Multiple Sclerosis is believed to be an autoimmune disorder but the precise cause of multiple sclerosis is not known. It is more common in females and the common age of onset is in the most productive age group of 25-35 years. With increase in the number of neurologists and easy availability of MRI machines we are diagnosing more cases in India. The awareness about multiple sclerosis is gradually increasing in urban cities but multiple sclerosis remains undiagnosed in the large section of the rural population and there is yet greater need for improving awareness in both urban and rural areas. The of lack of knowledge about this condition, employers often fail to understand the plight of employees with multiple sclerosis. Shortage of rehabilitation centers and specially trained nurses clubbed with poor public infrastructure makes living with multiple sclerosis a struggle for patients." Dr Joy Desai, Consultant Neurologist, Jaslok Hospital and Research Center,Mumbai said, "Patients sometimes face discrimination at work place and in the society as a whole, mainly due to lack of awareness about the disease. They have low self esteem as they lose their rigor of youth and subsequently the ability to function optimally at workplace. Society should me more sensitive towards these patients and recognize the fact that the human body is vulnerable to auto-immune diseases, and their occurrence is beyond human control." The average cost of patented multiple sclerosis injection comes around Rs 40,000 per month. According to estimates, there is between 100,000 - 200,000 multiple sclerosis patients in India, however there are no exact statistics available. ]]> <![CDATA[ICAR must develop IP for nation says Prof Sen ]]> https://biospectrumindia.com/news/95/6101/icar-must-develop-ip-for-nation-says-prof-sen-.html https://biospectrumindia.com/news/95/6101/icar-must-develop-ip-for-nation-says-prof-sen-.html Thu, 24 Oct 2013 15:29:00 +0530 AgrInnovate India incorporated on October 19, 2011 as a "not for profit" company owned by the department of agriculture research (DARE), ministry of agriculture, government of India, celebrated its second foundation day and conglomerate on innovative partnerships recently at Delhi. The company acts as an effective interface between Indian Council for Agricultueral Research (ICAR) on one side and the stakeholders of agricultural sector on the other side, for a significant purpose of securing, sustaining and promoting global agricultural development. Prof Abhijit Sen, member, Planning Commission who was chief guest on the occasion, mentioned that today knowledge and technology are becoming the intellectual property rights and it brings benefits for those who own it. He appreciated the ICAR and AgrInnovate India Ltd. for encouragement of entrepreneurship and innovations and further urged that ICAR should concentrate on development of intellectual properties for the nation for better utilization of resources and to create entrepreneurships among farmers. Prof. Sen also launched the website of AgrInnovate India. (http://agrinnovate.co.in) and inaugurated the exhibition for showcasing the promising NAIP technologies on the occasion. The showcasing was organized by Directorate of Knowledge Management in Agriculture in collaboration with NAIP. In his remark, Dr S Ayyappan, Secretary, DARE and Director General, ICAR and Chairman, AgrInnovate India emphasized upon the need of harnessing the synergies with industries for transfer of technologies by pooling resources collaboratively. He said that Public-Private Partnership (PPP) and Business Planning and Development (BPD) units play an important role in IP transfer and AgrInnovate is providing platform to promote development through IPR protection, commercialization and partnerships both in the country and abroad.Arvind Kaushal, Additional Secretary, DARE and Secretary, ICAR and Vice-Chairman, AgrInnovate India Ltd. lauded the role of AgrInnovate in research and development, production of seed and vaccine, IPR, entrepreneurship and capacity building to secure the livelihood of farmers. Dr D. Rama Rao, National Director, National Agricultural Innovation Project (NAIP), highlighted the achievements and role of NAIP in technology transfer and commercialization of new technologies. He said that NAIP and AgrInnovate are playing an important role for attracting and retaining youth in agriculture through different capacity building programmes. Earlier, Dr M.M. Pandey, CEO, AgrInnovate India Ltd. welcomed the dignitaries and briefed the gathering about the mission and objectives of the company. AgrInnovate has been established with a vision to stimulate, foster, enhance and catalyze innovation and capacity driven agricultural development through partnerships. Dignitaries released the logo and brochure of the company. Eight entrepreneurs were facilitated on the occasion. Scientists and officials from ICAR, NAIP and BPD units participated in the event. ]]> <![CDATA[Stelis Biopharma signs research collaboration agreement with Bio-Scaffold International]]> https://biospectrumindia.com/news/95/7397/stelis-biopharma-signs-research-collaboration-agreement-with-bio-scaffold-international.html https://biospectrumindia.com/news/95/7397/stelis-biopharma-signs-research-collaboration-agreement-with-bio-scaffold-international.html Wed, 23 Oct 2013 22:49:48 +0530 This collaboration is expected to research and develop BMP and stem cell loaded 3D printed devices for various applications in orthopaedics, cosmetology or plastic and reconstructive surgery and dentistry. The company said that the research will be jointly directed by Dr Anand Iyer, CEO, Stelis Biopharma and Dr Margam Chandrasekaran, CEO & chief scientist, Bio-scaffold International. It is said that each company will bear the cost of its contribution to this joint research collaboration. BSI is a pioneer in the application of 3D printing technology for the development of novel, biocompatible scaffolds. Stelis is a biotechnology company whose research and development efforts include the development of drug and stem cell loaded devices for the treatment of various medical conditions. Scientists from Stelis and BSI have developed a framework for initial research collaboration which would include working on multiple areas such as BMP-2/7 heterodimer loaded scaffold for orthopaedic applications and BMP2/ BMP7 loaded scaffolds for spinal fusion. Dr Iyer and Dr Chandrasekaran said that this joint collaboration would help harness the synergies of the two companies in advancing the development of novel 3D printed devices for effectively treating various conditions in the orthopaedic, orthodontic oral or maxillofacial and plastic or reconstructive arena. ]]> <![CDATA[Lucknow hosts workshop on drug designing ]]> https://biospectrumindia.com/news/95/4730/lucknow-hosts-workshop-on-drug-designing-.html https://biospectrumindia.com/news/95/4730/lucknow-hosts-workshop-on-drug-designing-.html Wed, 23 Oct 2013 17:47:00 +0530 The workshop will familiarize the participants with topology coordinates identification, in-silico target molecule properties evaluation. It also has an objective to apprise the participants with the recent methods of molecular dynamics simulations which lead to the successful design of proficient, precise and non-toxic small-molecules through guided practical training. Designing and developing a new drug molecule is increasingly becoming a time and cost intensive process, which has limited the rate of drug discovery and very few new molecules are reaching into the market. Computational methods have been in use for various forms of drug discovery like QSAR, Molecular Simulations, Molecular Docking, Virtual Screening and Structure-based drug designing methods for some time. Drug Designing is the inventive process of finding new medications based on understanding of the biological target. The participants of the workshop will be accessing offline and online resources of macromolecule libraries, molecular docking, molecular simulations and novel drug discovery. They would also learn about prediction and analysis of various properties of compounds, bimolecular structure prediction, visualization, interaction analysis and Pharmacophore designing. The practical knowledge gained through this hands-on workshop will empower participants in the field of in-silico drug development methods and enhance their employment potential in academia and industrial research. The workshop will consist of lectures, group discussions, case studies, exchange & sharing of experience on Bioinformatics and its application Biological Databases Functional Genomics and Proteomics Structural Bioinformatics and much more. It is expected to be attended by scientists, research fellows from national laboratories and universities. ]]> <![CDATA[Monsanto to face HC's music for biopiracy]]> https://biospectrumindia.com/news/95/5159/monsanto-to-face-hcs-music-for-biopiracy.html https://biospectrumindia.com/news/95/5159/monsanto-to-face-hcs-music-for-biopiracy.html Wed, 23 Oct 2013 14:40:49 +0530 ESG's campaign against Bt Brinjal, the country's first-ever genetically modified food, started in 2006. It claimed that the Bt Brinjal posed a major threat to peoples health as it is a 'lab-cultured' food', developed 'instransparently' after being 'poorly tested'. On October 11, 2013, the Karnataka High Court dismissed all the petitions challenging criminal complaints against Monsanto. It is alleged that endemic varieties of Brinjal were accessed by UAS (University of Agricultural Sciences), Monsanto and Mahyco. After which, Monsanto's proprietary Bt Gene were inserted in the local varieties of Brinjal to create the Genetically Modified Bt Brinjal. ESG claims that the developers of Bt Brinjal has not taken permission from the State Biodiversity Board and the National Biodiversity Authority, during the making of Bt Brinjal. ]]> <![CDATA[Biocon Foundation â€“ Social impact through sustainable community development]]> https://biospectrumindia.com/features/95/6568/biocon-foundation-social-impact-through-sustainable-community-development.html https://biospectrumindia.com/features/95/6568/biocon-foundation-social-impact-through-sustainable-community-development.html Tue, 22 Oct 2013 11:45:00 +0530 As an emerging global biopharmaceutical enterprise focused on delivering affordable healthcare, Biocon's commitment goes beyond developing new medicines. Biocon is engaged in providing sustainable solutions to address the myriad healthcare challenges faced by the country as a part of its Corporate Social Responsibility (CSR). Biocon's Foundation believes that the corporate social responsibility will be best fulfilled by creating a comprehensive and integrated ecosystem which can deliver affordable and effective healthcare to the less privileged among India's rural and urban population. It supports education initiatives imparting better learning to the underprivileged students in rural schools. It is also constantly engaged in empowering communities through sustainable solutions and have facilitated for better infrastructure including health-centers, community centers, primary schools, proper sanitation, water and light sources in various districts of rural Karnataka. The Foundation believes in making a meaningful social impact through collaborative approach and is constantly engaged in several public-private partnerships to implement integrated programs aimed at making a difference. Biocon's comprehensive healthcare efforts span preventive, primary, secondary and tertiary healthcare programs. Under its preventive health education programs, Biocon realized that preventing and managing chronic disease would be challenging. Patients must often change their lifestyle and behavior. Thus, the Foundation has fused elements of education and prevention by implementing an extensive preventive health education programs. This addresses water-borne diseases, hygiene-related and chronic illnesses, as well as maternal health and childcare. To raise awareness about hygiene and sanitation related illnesses, which account for a significant number of patient complaints in rural areas, Biocon's Community Health Workers (CHWs) conduct preventive health workshops to educate villagers on nutrition, personal and environmental hygiene, good sanitation and hand washing habits. The workshops have been attended by almost 200,000 women and children so far. Biocon Foundation has also taken the initiative to build over 800 toilets in Karnataka to not only ensure better health for all community members but also the safety and privacy of women and children. Oral cancer still remains as one of the most debilitating and disfiguring of all malignancies. As part of its CSR commitment, Biocon has embarked on an innovative program that leverages technology for the early detection of oral cancer through mobile phone screening and education. This is a collaborative program with the state government and ASHA (Accredited Social Health Activist) workers. The oral cancer screening program conducted by the Foundation in high risk groups in three pilot villages in FY13 covered over 5,000 people. Of these, over 300 individuals were detected with positive lesions, who were then taken to the nearest diagnostic center for a biopsy. The program has led to early intervention and potential cancer cure. It also aims to drive the cessation of tobacco products usage, which is the root cause of oral cancers. Biocon Foundation has also rolled out a comprehensive cervical cancer screening and treatment program in collaboration with the Mazumdar Shaw Cancer Centre (MSCC). The program aims to target a substantial percentage of women in the High Risk Group (sexually active women in the age group of 30-49 years) in our field practice areas. Malnutrition, in children, is another area that is addressed by Biocon Foundation. A government survey in the Bagalkot district of North Karnataka had identified that over 3,000 children under the age of five were malnourished. In partnership with the Bagalkot local administration, Biocon Foundation rolled out a program to address this issue. The Foundation has about 9 Arogya Raksha clinics operating in various districts of rural Karnataka, offering clinical services to the communities around them. These services ensure that the rural poor have access to efficient health management via competent clinical care, disbursal of affordable generic medicines and simple cost effective diagnostic tests. As many as 75,000 patients benefited from these clinical services in FY13. Biocon's CSR wing also continues to encourage communities to protect themselves against catastrophic illness by enrolling with Arogya Raksha Yojana, a micro health insurance scheme, with very low premiums. The insurance scheme offers its members access to highly qualified doctors and surgeons who enable expensive surgeries for cardiac and gynecology procedures in the best of hospitals almost free of cost. Since education holds the key to progress, the Biocon Foundation has made concentrated efforts to empower rural Indian youth. Aiming to provide computer-aided learning, extracurricular activities, life skills education, and English language skills for rural children, the Foundation has spearheaded several education programs such as Chinnara Ganitha, which seeks to strengthen the learning of basic mathematical concepts; Aata Paata Wadi, an after-school resource center for children from local government schools; Kelsa+, an initiative that tries to inexpensively reach out to low-income staff in Biocon's campuses. The Chinnara Ganitha program has generated data that indicates that children have significantly benefited from these books. Their computational skills are way above those who have not had access to these books. From 11,000 Chinnara Ganitha maths work books in 2006, it now prints over 100,000 books. The Foundation also provides support for infrastructure in some villages like community centers, primary health clinics, proper sanitation, safe drinking water, and rain water harvesting facilities. More importantly, Biocon has built a new village to resettle villagers of Mangalgudda in North Karnataka, which was washed away in floods a few years ago. The Foundation's efforts were directed at constructing over 400 new houses equipped with toilets and solar lights for each house. A primary healthcare center and a school was also set up to make the village self-sustained. The houses were handed over to the government and are now being allotted to the villagers. Being socially responsible is a pre-requisite for being sustainable. As a result, Biocon today integrates CSR thinking into every aspect of its business and is always looking for ways to create economic value, and at the same time address society's needs and challenges. Biocon Foundation through its various initiatives aims at social and economic inclusion by ensuring that marginalized communities have equal access to healthcare services and educational opportunities. ]]> <![CDATA[Kisan mela organized at Lucknow Biotech Park ]]> https://biospectrumindia.com/news/95/6189/kisan-mela-organized-at-lucknow-biotech-park-.html https://biospectrumindia.com/news/95/6189/kisan-mela-organized-at-lucknow-biotech-park-.html Tue, 22 Oct 2013 11:40:00 +0530 Agriculture Technology Management Agency (ATMA), Department of Agriculture organized a Kisan mela at Biotech Park, Lucknow during the month of September. The minister of state for animal welfare, Uttar Pradesh Government, Mr Shiv Pratap Yadav, inaugurated the Kisan Mela and the impressive exhibition organized on the occasion. Mr Vivek Kumar Singh, Deputy Director, Agriculture, Mr S P Upadhayay, State Consultant, ATMA Yojna, Sri Uday Veer Singh, CDO were present on the occasion. Dr P K Seth, CEO, Biotech Park welcoming the honorable minister, said that it is a very important event where farmers, entrepreneurs, government officials all have gathered at Biotech Park which is a technical incubator. Biotech Park has been supporting such initiatives of organizing 'Kisan melas' in the past. This help in increasing the awareness among the farmers about the new technologies which have applications in agriculture. Farmers will be able to see the various facilities and products which are of interest to them. The minister and other officials would be able to see the facilities which will help them in drawing plans for taking the technologies to the farmer's field and provide them biotech products for boosting their economy. Mr S P Upadhyay, ex-director, Department of Agriculture, and State Consultant, ATMA Yojna said that extensive uses of chemical fertilizers are harmful for the land and also informed the farmers about the various schemes of ATMA. He suggested that farmers should take the advantage of the ATMA Yojna and join hands with government and utilize the facilities being provided under this program. The minister while addressing the audience mentioned, "I am extremely happy to be here to participate in the kisan mela. He thanked Biotech Park for helping in the organization of the Kisan Mela." He also thanked for the initiative taken to apprise the farmers about facilities available and services being provided by the various government departments for the benefit of the farmers. He urged the farmers to adopt new technologies and practices in farming. He suggested farmers not to sell their farm lands under pressure or allure given by builders and if they have any problem, they can directly made complaints to the government. There were over 16 stalls in the exhibition. Biotech Park also set up a stall to show case the various products including biofertilisers and tissue cutlture banana plants and services which it offers. A large number of kisans visited the stall and purchased materials. Honorable minister and a large number of kisan visited the Biotech Park stall and other stalls. Besides kisans, various self help groups and officials from various departments of state participated in the Mela. Experts from government and park delivered lectures about modern techniques of farming, soil analysis, seed selection and use of tissue culture plants. ]]> <![CDATA[Coffman receives the 2013 GCHERA World Agriculture Prize]]> https://biospectrumindia.com/news/95/4528/coffman-receives-the-2013-gchera-world-agriculture-prize.html https://biospectrumindia.com/news/95/4528/coffman-receives-the-2013-gchera-world-agriculture-prize.html Tue, 22 Oct 2013 11:34:00 +0530 Ronnie Coffman's efforts are being recognized by the inaugural World Agriculture Prize, awarded by the Global Confederation of Higher Education Associations for Agricultural and Life Sciences (GCHERA), an organization that represents more than 600 universities worldwide. As a rice breeder at the International Rice Research Institute in the Philippines in the 1970's, Coffman, Ph.D. '71, helped one generation survive the ravages of war by ensuring food security throughout Southeast Asia. As leader of the Borlaug Global Rust Initiative-and the Durable Rust Resistance in Wheat project funded by the Bill & Melinda Gates Foundation and the UK Department for International Development- he is helping another generation combat new strains of wheat rust that threaten to devastate world food supplies. Recently he was in India to attend the global technical workshop on wheat at New Delhi. Professor Coffman had then disclosed that India had three varieties - Super 152, Super 172 and Baj - that were resistant to stem rust. Besides, 37 more varieties were in the pipeline. As the professor behind Cornell's popular "Agriculture in Developing Nations" course, director of International Programs in the College of Agriculture and Life Sciences (IP-CALS), and organizer of Ph.D. training courses at the West African Center for Crop Improvement, he is mentoring the next generation of plant breeders and international development professionals. "The world's farmers need access to the best science that the many great institutions of GCHERA can deliver in order to produce crops that are nutritionally adequate and best adapted to future challenges," Coffman said during his acceptance speech at Nanjing Agricultural University in China on Oct. 20. New technologies - including biotechnologies - must be made accessible to all the world's farmers so that nutritionally superior seeds that are well adapted to climate change are put in the hands of farmers with limited resources, he added. Coffman also advocated for the advancement of women in agriculture and science, and committed the $50,000 proceeds of the prize to AWARE (Advancing Women in Agriculture Through Research and Education), a new initiative to ensure that gender is considered in all IP-CALS activities, from events to funding proposals. "Women hold the greatest potential to make significant impacts in rural development," said Coffman. "Colleges of agriculture and life sciences need to empower women as future champions around the globe so they can become the entrepreneurs of their own future as well as the planet's." Coffman was nominated for the award by Kathryn Boor, the Ronald P. Lynch Dean of CALS, who said he embodied the college's mission of "knowledge with public purpose." "Ronnie excels as an agent of change. He has spent his career ensuring that people with scarce resources in some of the world's most populous countries have access to the agricultural science they need to produce crops best adapted to the challenges they face," Boor said.A Kentucky native, Coffman had never even seen the ocean prior to coming to Cornell as a graduate student in 1967. His first trip off the continent was to Puerto Rico, as a participant in the class he now leads. Coffman now travels more than 150 days and 250,000 miles a year in pursuit of advancements in agriculture and rural development. Coffman joined the Cornell faculty in 1981, and has served as director of IP-CALS since 2001. Previous positions include chair of the Department of Plant Breeding and Genetics, CALS associate dean for research and director of the Cornell University Agricultural Experiment Station. ]]> <![CDATA[Funding drought continues, industry looks for mentors ]]> https://biospectrumindia.com/features/95/6409/funding-drought-continues-industry-looks-for-mentors-.html https://biospectrumindia.com/features/95/6409/funding-drought-continues-industry-looks-for-mentors-.html Tue, 22 Oct 2013 11:11:00 +0530 With an increasingly short supply of capital, the environment for bioscience venture finance continues to remain challenging. Despite factors such as aging population and rising living standards in India that support long-term demand for life science innovation, the funding is way far lesser. If we look at the sources of funding in Indian bioscience sector from the very beginning, it has been mainly from the government agencies and less from private investors. However, over the period of time, there has been a rise in the private participation. While the companies at middle and higher levels are getting support, the start-ups at proof-of-concept find it very hard to sustain up to the product development stage. Experts confirm that the early-stage funding is far too less, while the mid stage is 35-40 percent and advanced stage is 45-50 percent respectively. The fact remains that only few Venture Capitalists (VCs) exist in this country. The successful conversion ratio is very slow and there is scarcity of resources with lifesciences background. The first time lifesciences investors are more likely to back companies with less technological or development risk, such as those involving smaller clinical trials or an accelerated regulatory pathway, or that requires less capital to reach commercial markets. Ms Deepanwita Chattopadhyay, managing director and chief executive officer, IKP Knowledge Park, which provides `50 lakh worth grant to companies who have a solid idea with clear roadmap on it added, "So far there has been $5-7 million worth of transactions and 11 companies in lifesciences area and one hospital have benefited." The VCs such as VentureEast are more focused on biotechnology market and over 80 percent of their funding goes into the sector. Says Mr Jagannath Samavedam, partner, VentureEast, "We have $ 100 million fund for the companies who present an innovative idea and plan. We have a scalable and service model. Among the firms that got funded by us include Metahelix, which was the first in India, Intas Bipharma, Advanced Enzymes, Indus Biotech, Rubicon, Natco and many others. The differentiated models are key to higher conversion ratios." "The alternative medicine firms because of short incubation time frame are now evoking good attention from VCs," felt Mr Sujay Shetty, senior consultant and leader for pharma and lifesciences, Pricewater houseCoopers. "In Indian context, it is very important to have emphasis on scale of innovation," he added further. Mr Shetty seems to have a valid point here. Earlier in 2013, Marck Biosciences, an Ahmedabad-based manufacturer and marketer of sterile liquids pharmaceutical dosages using the Blow-Fill-Seal (BFS) technology, sold a minority stake to Tata Capital Healthcare Fund. Tata Capital will invest `45 crore in the company and has picked up a 22 percent stake as well. LifeCell International, one of India's largest and most accredited stem cell banks, announced it is securing an investment from Helion Venture Partners, an India focused venture fund. With investment of `35 crore, Helion Venture Partners becomes the first venture capital firm to invest in a stem cell banking company in India. Emphasizing that they are into impactful funding, Mr Pinaki Bhattacharyya, chief investment and incubation officer, Villgro Innovation Foundation, emphasized on turning ideas into enterprises. He said, "Our areas of operation include agriculture, health, energy, and education. We currently have $1 million and are running a 12-month program for potential clients in Chennai." Sharing his perspective on international funding agencies, Dr Shirshendu Mukherjee, senior strategic advisor, Welcome Trust, mentioned, "These agencies play a pivotal role in promoting scientific research in India and beyond, in the challenging areas of bioscience research in human health, agriculture, green technologies, and related sciences. Though it is well argued and rightly so, that India, since the last decade has increased its funding in bioscience research considerably, and funding for a scientifically strong research problem is not at all an is sue in India now." Talking about his organization, Dr Shirshendu mentioned further that they have 30 million pound fund to support projects in the area of affordable healthcare. At the same time he is quick to point out that it applies only to late stage and specific projects that focus on certain disease areas. With venture capital lagging, large lifesciences companies are playing an increasingly significant role in supporting start-ups through partnerships or mergers and acquisitions. But companies and investors are taking steps to achieve early exits as a result. However, the happy news is that valuations for the venture-backed companies continued to show a upward trend. While raising venture financing is slowly opening up, those companies that do raise additional money are doing so at improved valuations. Interestingly, while investments in biotech, biopharmaceuticals, and medical devices may be dwindling, the same is not true for companies working in consumer-healthcare engagement, data analytics, or technology to make practicing medicine more efficient. VC funding in healthcare information technology sector continued at a torrid pace in Q1 2013 with $493 million in investments according to Mercom Capital Group. Not just investors, they require mentors! While funding from corporate investors, wealthy individuals, and disease foundations is helping to fill some of the gap, entrepreneurs who plan to seek venture capital financing would do well to carefully consider factors, such as capital efficiency and a faster path to exit, that can increase the odds of raising scarce funding. The investors generally are ready to support quality projects with low-risk factors. But what about those who are sitting on a good concept but have higher risk of failure? Early phase funds are too less in number as fund managers always look at potential sources only. In that case, they often feel like orphans with no guidance on which road to take and how. Ms Deepanwita mentions that whenever someone approaches them, there is always a question whether the funds are for infrastructure or any other purpose. She explained further, "They require business mentors as a lot many of them don't have expertise in intellectual property and regulations. A lot more discussion is required on capacity building." "VC funds invest more than what government agencies have to offer. For example, a startup requires `15- 20 lakh worth of seed capital to build up business and at a later stage it needs `15-20 crore to grow but in between the support seems to be lacking. Only 15-20 percent gets converted into success. VC funding too has limitations and that is why checks and balances have to be ensured so that funding doesn't go on half baked plans," said Mr Jagannath. Another area of concern that analysts feel is the unavailability of higher-scale funding. For the companies to look at funds beyond `2 crore is a major issue in this industry. The only way out seems to be angel networks, which too are highly selective about supporting firms. Dr Shirshendu Mukherjee believes that innovation has to be strongly funded. He added, "Since public good is our priority, strong science has to be the basic criteria." Create options Though very appreciative about various government schemes in ensuring critical support, most of the industry leaders feel that there is a need to lessen the paperwork and do away with certain rules. On the other hand, the government agencies don't want industry to only rely on them for their growth. "Adequate funding is no doubt critical for science and our government has accorded high priority to this aspect. Unfortunately, private sector investment into R&D has not grown fast enough for us to double the overall national investments into R&D, from the current level of 1 percent of GDP to 2 percent. Increasing private sector investments into R&D and making possible conversion of knowledge into value and wealth remains a challenge that I would like the national science council to look into," remarked the Prime Minister, Manmohan Singh after the release of the book "Science in India (2004- 13): Decade of Achievements and Rising Aspirations", in New Delhi on July 08, 2013. The statement in itself presents the state-of-affairs of public funding for Indian science. Dr Renu Swarup, managing director, Biotechnology Industry Research Assistance Council (BIRAC), during her recent interaction with the industry admitted that there were limitations with the government funding. She emphasized on the need to partner with private investors. "We do realize that the government funding has some limits and we cannot come up with huge funds at times. Hence, the best way to improve funding scenario is that we partner with private investors ensuring that deserving companies receive support at the right stages of product development," said Dr Swarup. Dr Swarup also drew attention to the recommendation made on setting up of manufacturing fund by Dr M K Bhan, former secretary, DBT, at a recently concluded BIRAC Innovators meet. She also assured that BIRAC's portal would undergo further revamp and asked Association of Biotechnology Led Enterprises (ABLE) to play more proactive role in ensuring free flow of communication between various stakeholders. ]]> <![CDATA[If technology is not affordable, it will not be accessible for the neediest people: Dr APJ Abdul Kalam]]> https://biospectrumindia.com/news/95/7823/if-technology-is-not-affordable-it-will-not-be-accessible-for-the-neediest-people-dr-apj-abdul-kalam.html https://biospectrumindia.com/news/95/7823/if-technology-is-not-affordable-it-will-not-be-accessible-for-the-neediest-people-dr-apj-abdul-kalam.html Mon, 21 Oct 2013 17:07:03 +0530 GE Healthcare on October 20, 2013, launched a first-of-its-kind healthcare technology experiential lounge on wheels - 'Mission Healthier India' in New Delhi. The specially designed healthcare vehicle from GE was flagged off by former Indian President, Dr A P J Abdul Kalam, in the presence of Mr Banmali Agrawala, president & CEO, GE South Asia, Mr Tom Gentile, president & CEO, GE Healthcare Systems, and Ms Terri Bresenham, president & CEO, GE Healthcare South Asia. Speaking on the occasion, Dr A P J Abdul Kalam said, "Technology is a key enabler for better healthcare. If technology is not affordable it will not be accessible for the neediest people. The most important aspect is teams working in healthcare - both research and clinical areas, have to have an attitude with a mission 'What can I give?'. This attitude of 'What can I give?' will lead to 'Let my brain remove the pain.' and bring smiles to suffering people. I am happy to see team GE having this attitude and innovating technology solutions to make healthcare accessible and affordable." The 'Mission Healthier India' is an experiential and educational lounge with 20 low-cost GE innovations on board. The Lounge will provide clinicians a hands-on experience on these advanced technologies catering to women, mother & infant care, cardiac diseases and critical care. Speaking about the initiative, Mr Banmali Agrawala, president, GE India, said, "Over 70% of Indians live in smaller towns and rural areas with limited access to quality medical infrastructure, including skilled manpower and technologies. GE is here to create a positive impact on the lives of every individual through its path breaking innovations. We have some of the best people working with us in India, who are engaged in developing solutions that make quality and affordable healthcare accessible to all." With the 6 new experiential vehicles, GE Healthcare hopes to reach 200,000 clinicians around the country, especially in smaller towns and villages. The mother & infant care technologies include ultrasound imaging systems for diagnosing health of babies and expectant mothers, infant care technologies like 'Embrace' provides mother's womb like warmth, 'Lullaby LED Phototherapy' system for treating neonatal jaundice, battery operated ECG systems for early detection of cardiac diseases, and critical care tools required for monitoring and supporting critically ill patients and reducing infections in ICUs. Terri Bresenham, president & CEO, GE Healthcare South Asia, said, "'Mission Healthier India' is our endeavor to showcase technologies that bring quality healthcare closer to people of India. Our technologies and solutions created in India, for India, have proved to dispel the notion of quality healthcare only comes with a steep price." Ms Bresenham further added, "This initiative is an instrumental platform to reach out to healthcare providers who have taken on the responsibility of elevating the standards of patient care in the smaller cities and villages of India. GE targets to develop 100 low-cost solutions in India to address India's and world's healthcare challenges in the area of cancer, cardiac diseases and maternal & infant care." ]]> <![CDATA[Transasia's subsidiary ERBA Diagnostics Mannheim GmbH fortifies its presence in the Middle East]]> https://biospectrumindia.com/news/95/6617/transasias-subsidiary-erba-diagnostics-mannheim-gmbh-fortifies-its-presence-in-the-middle-east.html https://biospectrumindia.com/news/95/6617/transasias-subsidiary-erba-diagnostics-mannheim-gmbh-fortifies-its-presence-in-the-middle-east.html Mon, 21 Oct 2013 15:15:57 +0530 Transasia's wholly owned subsidiary- ERBA Diagnostics Mannheim GmbH, headquartered in Germany is recognized as a leading player in the In-vitro diagnostic segment. Over the years, ERBA Diagnostics Mannheim GmbH has carved a niche in offering quality healthcare, globally through its various subsidiaries and expanding network in more than 90 countries. Rashed Al Makhawi healthcare, a division of Rashed Al Makhawi Enterprises of Dubai, has been the exclusive distributor of the ERBA group for the past eight years. Recently, Rashed Al Makhawi Healthcare brought together the eminent pathologists of UAE who interacted with the team from ERBA Diagnostics Mannheim GmbH at Dubai. The luncheon began with a series of informative presentations by the team from ERBA Mannheim representing their offices in Germany, USA and India. Mr Suresh Vazirani, Chairman of Transasia/ ERBA Group stated that, "We are excited to introduce ERBA Group's portfolio to this market. We have had a very successful relationship with Rashed Al Makhawi Healthcare and look forward to watching this grow as we increase our product portfolio. The ERBA Group's steady expansion is an opportunity to make all our global products available so as to bring the latest to healthcare facilities in this region." On this occasion ERBA Diagnostics Mannheim GmbH, presented Rashed Al Makhawi Healthcare with a prestigious award for 'The Most Promising Distributor.' On receiving this award, Rashed Al Makhwai Healthcare reiterated its commitment to build ERBA as a stronger brand and market the product extensively in the Middle East. The invitees also got an opportunity to see the latest products which were on display in the product walk-through section including the DS360 - an HbAlc Analyzer using HPLC technique. The displayed product range drew much attention from the invitees and finally translated into many orders. ]]> <![CDATA[Indo Japanese strategic cooperative program in biomedical research]]> https://biospectrumindia.com/news/95/5332/indo-japanese-strategic-cooperative-program-in-biomedical-research.html https://biospectrumindia.com/news/95/5332/indo-japanese-strategic-cooperative-program-in-biomedical-research.html Mon, 21 Oct 2013 14:45:10 +0530 The Department of Science and Technology (DST), ministry of science and technology. government of India, and the Japan Science and Technology (JST) will conduct the India-Japan Science & Technology Programme to promote bilateral scientific collaboration between Indian and Japanese scientists. The areas of cooperation include the medical diagnostics for early detection, particularly for infectious diseases. Apart from that the other areas include the system biomedicine and their computational platforms. The aim of the program is to strengthen collaboration between Japan and India within the area of "Biomedical Research" to achieve world-class scientific results, leading towards new innovative science and technology. This research area is currently undergoing remarkable development and is considered important on a global scale in achieving steady growth and sustainability in the long run. JST and DST plan to support cooperative research projects including exchange of researchers to the counterpart country. JST supports expenses for Japanese researchers, and DST supports expenses for Indian researchers. However, exchange visits of researchers for approved activities under the program would be supported in bilateral mode i.e. a dispatching side would provide a return air ticket and premium for overseas medical insurance, and the inviting side would provide local hospitality (accommodation, meals or per diem in lieu of and local transport). Applications are invited from eligible Indian researchers and scientists to submit proposals for joint projects.The joint application must include one Indian and one Japanese Principal Investigators, who would be responsible for technical as well as administrative co-ordination of the project and its periodic scientific and financial reporting to the DST/ JST respectively. ]]> <![CDATA[Ranbaxy receives CDSCO approval to market Synriam in India]]> https://biospectrumindia.com/news/95/8492/ranbaxy-receives-cdsco-approval-to-market-synriam-in-india.html https://biospectrumindia.com/news/95/8492/ranbaxy-receives-cdsco-approval-to-market-synriam-in-india.html Mon, 21 Oct 2013 14:05:32 +0530 Ranbaxy today announced that it has received approval from Central Drugs Standard Control Organisation (CDSCO) to manufacture and market Synriam (arterolane maleate and piperaquine phosphate tablet 150+750 mg) in India, for treating uncomplicated malaria in adults caused by Plasmodium vivax parasite. The company said that Phase III clinical trials for this drug conducted in India successfully demonstrated its efficacy and tolerability as comparable to chloroquine. Now further, the company has also received permission to conduct Phase III clinical trials for the pediatric formulation in pediatric patients of uncomplicated Plasmodium falciparum malaria. Commenting on the approval, Arun Sawhney, CEO & MD, Ranbaxy, said, "Synriam is a new age cure for malaria, and is fast emerging as the preferred option in the hands of doctors. This approval makes Synriam one of the few therapies in the world that successfully treats both, Plasmodium vivax and Plasmodium falciparum malaria. Ranbaxy remains committed in its fight against malaria and we are making all efforts to make this new therapy accessible to patients around the world." Traditional drugs are proving to be ineffective against the deadly malarial parasite because it has progressively acquired marked resistance to available drugs. Last year, Ranbaxy launched India's first new drug, Synriam, for the treatment of uncomplicated Plasmodium falciparum malaria in India. Since its launch, Synriam has successfully treated around one million patients said the press release. The company is also making efforts to make Synriam available in African, Asian and South American markets where malaria is rampant. The company said that it has also filed New Drug Applications (NDAs) for marketing Synriam in a few African countries. Synriam provides quick relief from most malaria-related symptoms, including fever, and has a cure rate of over 95%. The drug is also said to be conforming to the recommendations of the World Health Organization (WHO) for using combination therapy in malaria. The dosage regimen for Synriam remains as one tablet per day for three days. The drug is also claimed to be independent of dietary restrictions for fatty foods or milk, as is the case with older anti-malarial therapies. According to the WHO's World Malaria Report 2012, India has about 1.3 million confirmed cases of malaria each year. About 50% of them are caused by Plasmodium vivax, the second most important species after Plasmodium falciparum. Globally, 40% of total malaria burden is due to Plasmodium vivax. ]]> <![CDATA[Jubilant Foundation declares SEOY India Awardees 2013]]> https://biospectrumindia.com/news/95/3470/jubilant-foundation-declares-seoy-india-awardees-2013.html https://biospectrumindia.com/news/95/3470/jubilant-foundation-declares-seoy-india-awardees-2013.html Fri, 18 Oct 2013 18:07:51 +0530 The Jubilant Bhartia Foundation, which organizes the SEOY India Award in association with the Schwab Foundation for Social Entrepreneurship recently announced the finalists of the Social Entrepreneur of the Year (SEOY) India Award 2013. These included Breakthrough Trust (founded by Mallika Dutt), Mann Deshi Mahila Bank and Mann Deshi Foundation (founded by Chetna Vijay Sinha), Operation ASHA (founded by Dr Shelly Batra) and Yuva Parivartan/ Kherwadi Social Welfare Association (led by Mrinalini Kher and Kishore Kher). The winner(s) will be chosen by a distinguished jury and announced at an awards ceremony on November 11, 2013, in New Delhi. The finalists of the SEOY India Award 2013 are shaping change in fields as diverse as health, financial inclusion, human rights and employability and skilling. For the finalists, large-scale transformative change is a priority. They are actively nurturing collaborations with government, business and the citizen sector for the replication of their ideas, both within India and abroad. Another common strand that runs through their work is that they work in hostile and inaccessible geographies (i.e. the Naxalite 'red' corridor, drought-prone zones, and areas with high incidences of violence). Taken together, the finalists are seeding thousands of first-generation entrepreneurs/change agents in excluded territories, laying the foundations of a truly Inclusive India. According to Hilde Schwab, co-founder and chairperson, Schwab Foundation for Social Entrepreneurship "India remains one of the most dynamic regions for social entrepreneurship and the India Awards consistently attract a high quality of social enterprises. This year, we are also very excited to see an all women finalist pool. They are all working on highly inspiring visions and innovative strategies across critical areas including skill training, livelihoods development, disease control and empowerment of women." Congratulating the finalists, Shyam S Bhartia, chairman and managing director and Hari S Bhartia, co chairman and managing director Jubilant Life Sciences and founder directors of Jubilant Bhartia Foundation, said, "SEOY India Award recognizes the efforts of social entrepreneurs working as change agents for the society through innovation, sustainability, reach and social impact. We are delighted to see the transformative change that the finalists of this year have brought to the society". The SEOY India Awards received a record 209 applications. Through a five-stage selection process, the four finalists shortlisted after on-site visits, background research, reference checks and multiple rounds of deliberations. For the first time in the SEOY India Award, all the finalists are women social entrepreneurs, making this a special year for Social Entrepreneur of the Year India 2013. ]]> <![CDATA[Our gross domestic product in the R&D sector is only 1%: Hamid Ansari]]> https://biospectrumindia.com/news/95/5517/our-gross-domestic-product-in-the-rd-sector-is-only-1-hamid-ansari.html https://biospectrumindia.com/news/95/5517/our-gross-domestic-product-in-the-rd-sector-is-only-1-hamid-ansari.html Fri, 18 Oct 2013 16:14:40 +0530 The Vice President of India Shri M.Hamid Ansari awarded young scientists across from different parts of the country who participated in the 3rd National level exhibition and Project Competitions 2013 under the 'Innovation in Science Pursuit for Inspired Research' (INSPIRE) programme' organized by Department of Science and Technology. Speaking on the occasion he said it is now universally acknowledged that science and technology can significantly impact each of the three dimensions of sustainable development - economic, social and environmental. However, many challenges still remain and new ones are emerging as rapid growth in population and indiscriminate consumption is depleting our finite natural resources and irreversibly transforming the planet. In the future, science and technology will be critical in finding answers to these seemingly intractable challenges.Shri Ansari said though our science output has reached 3% of the global output in 2010 still, much more needs to be done. As the country continue on the path of rapid, more inclusive and sustainable growth, we will have to do considerably better in the field of science and technology, not just for our own development but also to keep pace with the rest of the world. Our human resources are outstanding and given a fair chance and adequate resources, they can achieve almost the impossible.He expressed his concern on the present scenario where India fall short of global standards in science and technology and in research and development areas. the Vice-president said India's share of top 1% impact-making scientific publications in the world is only 0.5%, less than those of other Asian countries like China and South Korea. Inventiveness in our basic science, as indicated by creation of intellectual property, is low. India's innovation system ranking varies between 50 and 60 among the nations.He said our spending in our gross domestic product (GDP) in the R&D sector is only 1% which needs to be raised to 2% of GDP, just to match other developed and emerging economies. For a country of our size and population, our ownership of intellectual assets also needs to sow an increase - from a little more than 1900 filed by Indians and sealed in 2007 to about 20000 patents sealed per year by 2020.He congratulated all the young scientist who bagged award and asked them to continue working harder.Nearly 900 young scientists from 28 states and all the Union Territories except the Lakshadweep took part. ]]> <![CDATA[Majority of Indians don't know the real cause of stroke: reveals research by Ipsos]]> https://biospectrumindia.com/news/95/4256/majority-of-indians-dont-know-the-real-cause-of-stroke-reveals-research-by-ipsos.html https://biospectrumindia.com/news/95/4256/majority-of-indians-dont-know-the-real-cause-of-stroke-reveals-research-by-ipsos.html Fri, 18 Oct 2013 12:59:58 +0530 As a precursor to World Stroke Day 2013, the Indian Stroke Association (ISA) underlines the importance of creating awareness on the third largest killer in India - Stroke. As a part of this initiative, ISA commissioned a survey across India to understand the extent of knowledge that prevail about stroke against the Indian population. The research conducted by Ipsos, a leading market research agency, revealed that a majority of Indians do not know the real cause of stroke. The survey was conducted across men and women aged between 25-50 years. A total of 1507 people were interviewed from Mumbai, Delhi, Kolkata, Bangalore and Chennai. It mainly captured the respondents' awareness and understanding of the term 'Stroke', its symptoms, perceived causes, the prevailing knowledge about treatment options and their experiences with stroke sufferers. Stroke is a medical emergency and can cause permanent neurological damage, complications, and death. Brain attack or stroke, is the rapidly developing loss of brain function due to disturbance in the blood supply to the brain. It is caused due to block in blood vessel (ischemic stroke) or rupture of the blood vessel (hemorrhagic stroke) in the brain. Ischemic stroke has to be properly treated with the only available treatment approved world over to prevent the brain damage within 4.5 hours. However the study revealed that the ordinary people are not aware of stroke, its manifestations, the immediate course of action in its occurrence and the rehabilitation treatment for patients. Only half the people interviewed during the survey were aware that stroke affects the brain, may result in paralysis and needs treatment by a neurologist along with physiotherapy. The fact that stroke can occur without pain and often goes undiagnosed is not known to many. Even fewer are aware that specific clot reducing medication needs to be administered with in 4 hours of the stroke and doing so can prevent disability. According to a World Stroke Association survey in 2011, only 6.2% of people recognized stroke symptoms. Amongst those who were unaware of the symptom, majority of the respondents were young (below 35 years) which showcased that awareness level were lower in the younger generation of India. According to survey Mumbai's understanding is slightly better as compared to the rest of the country. "The survey clearly indicates that there is lack of awareness about the term stroke, its causes, preventive measures and immediate actions to be taken in case of a stroke occurrence. Today, there is a need to create greater awareness among the younger population who are the main observer of the acute event", said Dr Shirish Hastak, former president of the Indian Stroke Association (ISA), who has spearheaded multiple campaigns to create awareness on stroke. ]]> <![CDATA[Neuland Ranked as a top regulatory performer in survey of customers and industry leaders]]> https://biospectrumindia.com/news/95/4024/neuland-ranked-as-a-top-regulatory-performer-in-survey-of-customers-and-industry-leaders.html https://biospectrumindia.com/news/95/4024/neuland-ranked-as-a-top-regulatory-performer-in-survey-of-customers-and-industry-leaders.html Thu, 17 Oct 2013 17:58:00 +0530 Neuland Laboratories Ltd, a pharmaceutical manufacturer providing active pharmaceutical ingredients (APIs), complex intermediates and contract manufacturing services to customer located in 85 countries, announced it has been awarded a 2013 CMO Leadership award from Life Science leader magazine in the regulatory category, which complements the company's long track record of current Good Manufacturing Practices (cGMP) excellence. In accepting the 2013 award, Neuland's Chief Executive Officer, Mr. Sucheth R. Davuluri, commented, "Creating a quality-conscious organization has been a goal from our founding days, and we are proud that in our almost 30 years as an API and contract pharmaceutical manufacturer, we have compiled a consistent track record of cGMP excellence. We are honored that our strengths in regulatory reporting and processing have been recognized with a CMO Leadership Award from our customers and other industry leaders, as we strive to extend this record of comprehensive regulatory excellence." Neuland provides products and services to customers in 85 countries focusing on the US, Europe and Japan. It is inspected and certified by the most rigorous regulatory agencies in the world. Consistent with its record of cGMP excellence, Neuland's lst two FDA inspections had no Form 483 citation issued.Mr. Davuluri continued, "We intend to continue the high level of vigilance and oversight in every aspect of our operations that has enabled us to maintain this consistent record of quality and reliability, and we want to acknowledge the exceptional team at the Neuland who made this award possible, with their ongoing daily commitment to quality in everything that we do." The CMO Leadership Awards are based on responses of more than 10,000 pharmaceutical and biopharmaceutical executives to a survey conducted by nice Insight and sponsored by Life Science Leader magazine. the award recognizes those contract manufacturing organization that are the most highly rated by industry respondents. The survey covered more than 100 CMOs.The 2013 CMO leadership Awards will be formally presented at a ceremony in New York City on March 12, 2014. ]]> <![CDATA[India in-vitro diagnostics industry: accreditation and automation to drive future growth]]> https://biospectrumindia.com/news/95/7764/india-in-vitro-diagnostics-industry-accreditation-and-automation-to-drive-future-growth.html https://biospectrumindia.com/news/95/7764/india-in-vitro-diagnostics-industry-accreditation-and-automation-to-drive-future-growth.html Thu, 17 Oct 2013 17:54:00 +0530 Ken research has announced in its report, with a percentage share of 20.1% in the total IVD revenues, the biochemistry market in India was the second largest segment in FY'2013. Even though the share of this segment in the overall IVD revenues has declined for the last three fiscal years (FY'2011-FY'2013), the market has grown at a CAGR of 15.7% over FY'2007-FY'2013. The immunochemistry market has registered revenues of USD 408.8 million in FY'2013. The revenues increased by 40.2% from USD 291.6 million in FY'2012. The highest contribution to these revenues came from the sales of immunochemistry reagents, which along with instruments accounted for 50.5% of the total market in fiscal year 2013. The biochemistry market in India was dominated by Roche Diagnostics, accounting for a market share of 34.0% in fiscal year 2013. The company has been successful in capturing a major share of the biochemistry market over the years and offers IVD products for laboratories with varying workloads. For instance, Cobas 6000 provides medium workload laboratories with custom-made solutions for clinical chemistry testing, whereas Cobas 4000 is ideal for complete clinical chemistry solution in Laboratories with small workload. The key topics covered in research included India In-Vitro market size by revenues, immunochemistry market, biochemistry market, hematology market, microbiology market, blood gas and electrolyte market, molecular diagnostic market and so on. The research covered the market trends, growth drivers, market size and constraints. ]]> <![CDATA[Mumbaikars at high Cardiovascular Disease Risk, reveals Saffola life study 2013]]> https://biospectrumindia.com/news/95/4259/mumbaikars-at-high-cardiovascular-disease-risk-reveals-saffola-life-study-2013.html https://biospectrumindia.com/news/95/4259/mumbaikars-at-high-cardiovascular-disease-risk-reveals-saffola-life-study-2013.html Wed, 16 Oct 2013 17:49:00 +0530 The Saffola life Study 2013, India's largest study on risk factors precipitating heart disease, revealed that more than 70% of 1.86 lakh urban Indian respondents are at cardiovascular disease (CVD) risk. When the study was conducted among 29,017 people in Mumbai, the respondents over a period of three years, it was revealed that 72% of them had a high risk of CVD. The study also revealed that 51% of respondents in Mumbai had low levels of the heart protective HDL and 44% reported to be consuming preserved/processed foods at least two times a week. Supporting the Saffola life study, Dr Akshay Mehta, senior cardiologist,AsianHeartHospital, said, "Sedentary lifestyle, stressful work conditions and compromised diet are leading factors in precipitating heart disease risk. This has affected the heart health of the young work force in the 30 - 44 age group." According to the Saffola life study, Mumbai was one of the cities with least number of respondents with diabetes at 12% as compared to other metros. The study revealed that 42% of the Mumbai respondents also reported to consume fried foods at least two times in a week. Additionally, 71% of them were guilty of consuming two or less servings of fibre-rich whole grains in their diet. When the physical activity of Mumbai participants was analyzed, it emerged that a substantial 64% of them exercised thrice a week or less. 10% of the participants reported feeling drained four times a week or more.Young Productive Work force (30-44 years) is the worst hitThe Saffola life study is being conducted from the past three years across 12 cities and covering more than 1.86 lakhs people across 30-100 age group. The study revealed a shocking large difference between the heart age and the chronological age beginning at 30 years with a noticeable peak observed in the 40's. This meant that Young India's heart is aging much faster. Due to the presence of maximum systemic and lifestyle risk factors, respondents in the 30-44 age group showed heightened CVD risk. To understand the trend/changes we have analyzed the data for the year 2010-11, 2011-12, 2012-13 and the combined data for all the three years here.Some key findings of the Saffola life Study: -The trend study has observed that for nearly all parameters that count as risk factors for CVD, the younger age group is sharing the same levels of CVD risk as the older age group.-73% males in the age group of 30-34 years and 76% in 35-39 age group are at CVD risk and 85% of males in the age group of 40 - 44 years are at risk.-Around 60% of females in their 30's and 40's are shown to be at high risk.-Among the people with CVD risks, 66% of women showed a higher risk of CVD due to the presence of low HDL levels as compared to 50% men.-Among the people with CVD risks, 73% of the women exercise three times a week or less as compared to 63% males.-High risk cholesterol levels, skewed BMIs, low levels of cardio-protective HDL cholesterol and high blood pressure are some of the factors contributing to increased CVD risk among India's productive workforce (Age group: 30- 44).-An alarming peak is observed post 35 in females having heart age greater than actual age. ]]> <![CDATA[Carestream Health begins shipping small-format digital radiography detector to healthcare providers]]> https://biospectrumindia.com/news/95/4036/carestream-health-begins-shipping-small-format-digital-radiography-detector-to-healthcare-providers.html https://biospectrumindia.com/news/95/4036/carestream-health-begins-shipping-small-format-digital-radiography-detector-to-healthcare-providers.html Wed, 16 Oct 2013 17:22:00 +0530 Carestream Health announced it has begun shipping its wireless CARESTREAM DRX 2530C small-format digital radiography detector to healthcare providers across the globe. The detector which received FDA clearance several months ago, offers high quality, low dose X-ray exams for pediatric, orthopedic and general radiology applications. The new cesium iodide detector's smaller size and high DQE (Detective Quantum Efficiency) can enhance care for premature babies and infants in the pediatric ICU. It can also offer lower dose than computed radiography cassettes or gadolinium scintillator detectors. The 365-bed Children Hospital los Angeles was one of the first facilities to place an order for the new DRX 2530C detector. "We believe this new detector can enhance care by increasing the quality of X-ray images captured of premature babies in our 50-bed neonatal ICU," said Dr. Marvin Nelson, the hospital's Chairman of Radiology. "The ability for technologies and physicians to immediately view images of these fragile patient will also be a dramatic improvement over the processing times required by the CR cassettes we currently use." The new DRX 2530C detector fits into a tray located underneath an incubator, so it allows technologies to obtain X-ray images to monitor the condition of ill or premature babies without moving them. It is also ideal for tabletop exams such as knee, elbow skull and other exams that may require a patient to hold the detector or require a smaller field of view. "The DRX 2530C detector is the latest addition to our market-leading family of digital X-ray detectors that includes the DRX-1 detector and DRX-1C detector,"said Diana L. Nole, president, Digital Medical solutions, Carestream. "As we continue to invest in new detector technology, we are simultaneously expanding our family of DRX systems that allow healthcare facilities to retrofit or install new systems for X-ray rooms and mobile imaging." ]]> <![CDATA[ASLAN Pharmaceuticals secures $22 million in Series B financing led by Cenova Ventures]]> https://biospectrumindia.com/news/95/3930/aslan-pharmaceuticals-secures-22-million-in-series-b-financing-led-by-cenova-ventures.html https://biospectrumindia.com/news/95/3930/aslan-pharmaceuticals-secures-22-million-in-series-b-financing-led-by-cenova-ventures.html Tue, 15 Oct 2013 11:35:05 +0530 ASLAN Pharmaceuticals announce the completion of a Series B financing raising $22 million. The financing was led by Cenova Ventures and included other new investors Morningside Group and XinChen Ventures. Existing investors BioVeda Capital and Sagamore Bioventures also participated in the round. "We are proud to have assembled such a strong group of investors from China, Taiwan and the US that can support the development of our portfolio through efficient and high quality clinical centers in the region," said Dr Carl Firth, CEO ASLAN. "This round will allow us to complete at least five further studies and deliver robust proof of concept data on several of our programs."Jun Wu, Chairman and Managing Partner at Cenova Ventures said, "In the space of three years, ASLAN has demonstrated their ability to in-license and progress novel compounds through creative and efficient development strategies. Though several companies have attempted similar models, ASLAN is the first to execute successfully, due largely to its team and network of partners." The financing will also support the licensing of additional compounds in 2013 and 2014. ]]> <![CDATA[A 'Nobel' touch for RGCB's international symposium]]> https://biospectrumindia.com/news/95/4081/a-nobel-touch-for-rgcbs-international-symposium.html https://biospectrumindia.com/news/95/4081/a-nobel-touch-for-rgcbs-international-symposium.html Tue, 15 Oct 2013 10:52:00 +0530 The two-day symposium on "Legacy of Nitric Oxide Discovery: Impact on Disease Biology" will review the advancements made in this area since the 1980s. Till the 80s, Nitric Oxide (NO) was largely known as an air pollutant. Later, it was discovered to be a bio-messenger, involved in vital physiological and pathological processes. Prof Ferid Murad, currently a professor at the Department of Biochemistry and Molecular Biology, George Washington University, is expected to deliver the keynote address at the symposium, which will be attended by international experts in Nitric Oxide biology, along with researchers and scientists from all over India. Nitric Oxide, designated as the molecule of the year way back in 1992, is said to be a unique bio-signaller, capable of passing through cell membranes and regulating cellular functions. Pioneering insights of the role of NO in cellular pathways and disease biology have paved way for several scientific and medical breakthroughs. Prof Murad shared the Nobel Prize in 1998 for discovering the biological role of NO as a signaling molecule in the cardiovascular system, causing the dilation of blood vessels. The event will also bring in speakers including Prof Ferric C Fang, (University of Washington, USA), Prof David A Wink, (National Cancer Institute, Bethesda Maryland, USA), Prof Arthur L Burnett, (The Johns Hopkins Hospital, Baltimore, Maryland), Prof Jon Lundberg, (Karolinska Institute, Sweden), Dr Vasily A Yakovlev, (Virginia Commonwealth University, USA) and Dr Pradeep Kachroo (University of Kentucky, USA). The symposium will provide a great opportunity for young researchers to interact with global experts. Lectures and presentations at the symposium are planned to cover the role of NO in the pathogenesis and treatment of tuberculosis, viral infections, hypertension, cardiac ischemia, diabetes, cancer, neuro-degenerative diseases, reproductive disorders and plant diseases. This event is said to be the first collaborative program between RGCB and SRIBS. ]]> <![CDATA[BioAsia 2014 international lifesciences conference to bring innovation to the center stage]]> https://biospectrumindia.com/news/95/5964/bioasia-2014-international-lifesciences-conference-to-bring-innovation-to-the-center-stage.html https://biospectrumindia.com/news/95/5964/bioasia-2014-international-lifesciences-conference-to-bring-innovation-to-the-center-stage.html Fri, 11 Oct 2013 14:42:00 +0530 Carrying the theme 'Innovate. Evolve.', BioAsia's focus on 'Innovation in lifesciences' will be addressing increasing disease burden, and growing need for efficacious and affordable healthcare solutions. The main goal of this event is to highlight innovation as the driver of the lifesciences economy in the years to come said the press release. Mr Shakthi Nagappan, CEO, BioAsia, said, "BioAsia has always been about coming together to discuss the most relevant and futuristic trends around lifesciences. Exclusive and interesting topics pertaining to the need of the changing times have been discussed at this forum in the past. This year BioAsia takes another leap by bringing innovation at the center stage of discussion". Global leaders in the panel discussions will discuss on path breaking solutions in the sector, from innovative products to models that reduce R&D cost and at the same time increasing efficiencies, and innovative financing models that promote new business ideas. Mr Nagappan further added, "..... we are confident that the global business leaders, with demonstrated innovative capabilities coming together at BioAsia 2014, will add significant impetus to India's innovation path". BioAsia 2014, hosted by Government of Andhra Pradesh with the support of FABA (Federation of Asian Biotech Associations) and Pharmaceuticals Export Promotion Council of India (Pharmexcil) will feature comprehensive breakout sessions on bio-energy, drug discovery, bio-IT, bio-therapeutics, regenerative medicine and medical electronics and devices to discuss the contemporary developments in science & technology. The event is expected to attract participants including corporates, global thought leaders, scientists, regulatory bodies and foreign delegates from all over the world. In addition, a parallel event called 'AgBioAsia' will be focusing on health and nutrition with the theme 'Harnessing the potential of the global nutraceutical market' will be hosted by the Government of Andhra Pradesh in partnership with the International Crops Research Institute for the Semi Arid Tropics (ICRISAT) and FABA. ]]> <![CDATA[Dr Reddy's Lab rolls out PAS-X manufacturing IT business platform]]> https://biospectrumindia.com/news/95/3463/dr-reddys-lab-rolls-out-pas-x-manufacturing-it-business-platform.html https://biospectrumindia.com/news/95/3463/dr-reddys-lab-rolls-out-pas-x-manufacturing-it-business-platform.html Fri, 11 Oct 2013 14:25:00 +0530 Dr Reddy's deployed PAS-X for the first time as full-blown MES, covering all operations from material receipt to production. "Based on the good experiences with PAS-X V3 at our Hyderabad plant, we took this system as a template and rolled it out at our site in Visakhapatnam", said Mr Sanjay Mantri, director, Dr Reddy's Laboratories. He also added, "This way, the PAS-X MES was set up only within five months and we were able to quickly start producing the first trial batches. PAS-X helps us to ensure full compliance and highest quality right from the beginning." The pharmaceutical company aimed at implementing a fully tried and tested MES to ensure approval of the greenfield plant by all regulators, especially the US health authority FDA, said the press statement. The MES project was implemented by Werum's Asia Support Center in cooperation with Dr Reddy's Centre of Excellence. Now, Dr Reddy's Labs further plans to install Werum's PAS-X at its three other facilities within India. Werum Software & Systems AG is a German company which creates software products and solutions to its customers globally. ]]> <![CDATA[Transasia wins coveted 'Global Business Excellence Award 2013]]> https://biospectrumindia.com/news/95/3466/transasia-wins-coveted-global-business-excellence-award-2013.html https://biospectrumindia.com/news/95/3466/transasia-wins-coveted-global-business-excellence-award-2013.html Fri, 11 Oct 2013 11:50:21 +0530 Transasia wins coveted 'Global Business Excellence Award 2013' presented by Business Today. Transasia Bio-medicals was conceived to Transform Asia by improving the quality of diagnosis and provide affordable health care solutions. And today, it is recognized as India's largest in-vitro diagnostic company that has set global benchmarks by acquiring in last 5 years 10 overseas companies in the USA, Germany, France, Italy, Russia, Czech Republic and Turkey. "Transasia was set up to meet the need for reliable, affordable and innovative medical diagnostic solutions. We remain committed to providing the highest quality products and services and will continue in our endeavor with the same zeal and passion" Mr Suresh Vazirani added. Transasia Bio-Medicals has been conferred with the prestigious 'Global Business Excellence Award 2013' presented by Business Today. The award was presented by Union Petroleum Minister Mr Veerappa Moily. Initiated this year, Business Today - YES Bank carried out a survey of unlisted emerging companies who have been consistently contributing to their fields and delivering nothing short of the best. The most deserving amongst them were then presented with awards in various categories under the 'Emerging Companies Excellence Survey and Awards'. As many as 526 companies form all across India were part of the survey. ]]> <![CDATA[Ms Ranjana Smetacek appointed as new director general of OPPI]]> https://biospectrumindia.com/news/95/3465/ms-ranjana-smetacek-appointed-as-new-director-general-of-oppi.html https://biospectrumindia.com/news/95/3465/ms-ranjana-smetacek-appointed-as-new-director-general-of-oppi.html Fri, 11 Oct 2013 11:17:00 +0530 Ms Ranjana Smetacek is appointed as the new director general of OPPI (Organisation of Pharmaceutical Producers of India). She has over 25 years of experience with various global and Indian companies in public relations, corporate communications and government affairs, in India, the US and other countries. She is associated with the healthcare, hospitality and telecommunication industries, on national and international projects. ]]> <![CDATA[Novozymes opens world's first advanced biofuels facility in Italy]]> https://biospectrumindia.com/news/95/2986/novozymes-opens-worlds-first-advanced-biofuels-facility-in-italy.html https://biospectrumindia.com/news/95/2986/novozymes-opens-worlds-first-advanced-biofuels-facility-in-italy.html Fri, 11 Oct 2013 10:44:00 +0530 Beta Renewables is a leader in producing cellulosic biofuels and a part of the Mossi Ghisolfi Group, and Novozymes. Chairman and CEO, Beta Renewables, Mr Guido Ghisolfi said, "The advanced biofuels market presents transformational economic, environmental and social opportunities, and with this opening, we pave the way for a green revolution in the chemical sector." He further added, "We will continue to commercially expand Beta Renewables' core technology throughout the world, and we are very confident at this stage given the demand we see around the globe." The company said that this will be the world's first plant designed and built to produce bio-ethanol from agricultural residues and energy crops at commercial scale using enzymatic conversion. The plant is claimed to make use of 'green electricity' for all its energy demands, generated from Lignin, which is a polymer extracted from biomass during ethanol production. Since 2011, more than US $200 million were invested in R&D of the technology to produce cellulosic ethanol at the Crescentino facility said the press release. Mr Peder Holk Nielsen, CEO, Novozymes, expressed that the opening of the plant presents a leap forward and is truly the beginning of a new era for advanced biofuels. He said, "Here at this plant, enabled by Novozymes' enzymatic technology, we will turn agricultural waste into millions of liters of low-emission green fuel, proving that cellulosic ethanol is no longer a distant dream. It is here, it is happening, and it is ready for large-scale commercialization." The company believes that stable policy conditions are needed and that policy makers need to send clear signals to encourage necessary investments in advanced biofuels. In this regard, Mr Peder Holk Nielsen quoted, "Stable and predictable blending mandates, incentives for the collection of agricultural residues, and investment support for the first large-scale plants will help move the world substantially in terms of reducing greenhouse gases, stimulating economies, and providing energy security. Continued reliance on fossil fuels is not viable." A recent study by Bloomberg New Energy Finance said that transforming agricultural residues into advanced biofuels could create millions of jobs worldwide, economic growth, reduction of greenhouse gas emissions, and energy security by 2030. With this in mind, the company feels that government support is vital to accelerate the deployment of next-generation bio-refineries. Novozymes and Beta Renewables formed a strategic partnership in October 2012, making Novozymes as the enzyme supplier for Beta Renewables' current and future cellulosic biofuel projects. ]]> <![CDATA[â€œPraj aims to be among top players globally in industrial biotechnologyâ€?]]> https://biospectrumindia.com/interviews/95/6375/praj-aims-to-be-among-top-players-globally-in-industrial-biotechnology.html https://biospectrumindia.com/interviews/95/6375/praj-aims-to-be-among-top-players-globally-in-industrial-biotechnology.html Thu, 10 Oct 2013 16:28:00 +0530 In a recent interaction with the BioSpectrum, Mr Pramod Chaudhari, executive chairman, Praj Industries spoke on company's unique operations and future outlook. Q: What are the offerings of your company in the bioindustrial space? Praj is a knowledge-based company with expertise and experience in bioprocesses and engineering. It delivers know-how, license, engineering design, plant and equipment, project management, commissioning and customer care, and turnkey projects. The company offers technology, equipment and plants for brewery as well as water and wastewater treatment systems and critical process equipment for various industrial applications. The biobased products like fermentation performance enhancers and livestock health and nutrition products too form a part of its offerings. With over 500 references across five continents, we are a leading ethanol technology and plant supplier with a strong focus on 2nd generation bioethanol process development. Q: Please update us on the developments at Praj Industries in the last few years? Praj has achieved great experience and expertise in sugar based feedstock where fermentation is a key parameter followed by bioprocessing chemical engineering and other separation technologies. Building further on our strength, we have attained expertise in hydrolysis. Generally fermentation is very commonly used terminology in pharma but here I would like to talk here more in context of industrial biotechnology, the area where we have been now recognized both in India as well as globally. In that direction, we in 2008 established the world class research and development centre called the Praj Matrix in a 5 acre area at Pune. At this innovation center, we have multiple agenda. First step was involving the 1st generation technologies mainly making ethanol from molasses and feedstock. The second focus has been on the 2nd generation biofuels from cellulosic biomass and agri-residues. Now the 2nd generation commercial demo plant will lay the foundation of cellulosic ethanol technologyfollowed by biorefinery which will produce myriad biochemicals and bioproducts. Also, worldwide there are efforts going for launching lignocellulosic biomass to ethanol conversion technologies. Here in India, we are the company known to be at forefront. In Asia Pacific we are the only known player in this area whereas in US, there is plenty of work that is going on. We established a pilot plant for this purpose at our R&D centre in 2009. The installation of commercial demo plant to process 100 MTPD (dry basis) corn cob, corn stover and bagasse in first phase has commenced. Total energy integration, virtually NIL liquid dischage, rigorous pilot scale evaluating of over four years are some of the highlights of the project PACE as it is called. PACE stands for Praj Advance Cellulosic Ethanol Technology. Q: What about your efforts to make inroads in biorefinery business? Any other areas where you have entered in recently? We have also taken the initiative of producing agri-based biochemicals that can replace the existing petro chemicals. It is a rising area as people want something new from renewable molecules. Therefore, as an option to oil refinery, we are aiming to launch biorefinery where on one side you put the biowaste and from other side you get biofuels as well as other re-usasble byproducts. Now we are going to constructing a demonstration plant at Maharashtra which in itself is a first of its kind project in this part of world. The outlay is close to 100-150 crore and now we are looking for investors to take part in this important venture. I hope that government of India understanding the implications of this project too will take notice of it. Apart from that, we are also looking at producing bioingredients for poultry and dairy. We have started a factory for producing probiotics and vitamins for livestock. This area is an offshoot of the some of waste products from ethanol and brevery plants. These biobased products get further processed into value added products. We have already started commercial sales in the area. With initial successful testing, we are now positively looking at dairy industry as well. In FY 13-14, we will have 2-3 more products in offing, some in partnership and individually. We have started the monetization of our products at R&D centre and are looking at introducing the entire range of bioindustrial products in few years. Q: Please explain your foray into the waste water treatment? What kind of groundbreaking work is being undertaken by the company? Praj launched its water and wastewater treatment solutions over three years ago. Since then, Praj has supplied technology and systems for many industrial applications including pharmaceuticals, chemicals, agro chemicals, textiles and other Industrial Common Effluent Treatment Plants (CETPs) including orders from overseas. Recently, we commissioned a very complex Zero Liquid Discharge Plant for a textile CETP in Tirupur, which being a textile belt has been facing crisis of severe pollution of water bodies due to coloured effluents from bleaching and dyeing units. Our unique ZLD technology has been now instrmetal in solving this problem. We have recently also acquired Mumbai based Neela Systems which has broadened our range of water product and machinery offerings to pharma industry. Now from fresh water to waste water and bioprocessing equipments, we are meeting important requirements of this industry. Already we have top companies such Biocon and others on our list of clients. Industrial biotechnology being a very complex area, requires interdisciplinary expertise across areas. Therefore,I believe that as the first movers in this area, we are definitely having an edge over others. Q: You have now entered into healthcare and nutrition as well. What makes you venture into this area and what are the expectations? As part of its strategy of extending its expertise in biotechnology combined with its experience in agri processes, Praj Industries has launched its next set of biobased products - the livestock health and nutrition range (LHN). The current product portfolio covers Probiotics, amino acids, Vitamins and other biomolecules and Prophylactic disease controlling friendly microbes with immunity modulators. A 65,000 sq. ft production facility has commenced production of performance enhancers for distilleries and will now take on production of LHN products. The factory, located in the industrial zone near Pune, is designed to world class standards in hygiene. The facility can be expanded four fold. It will see further ramp up once success of this phase is established. Based on integrated approach and market insight, Praj will benefit from increased consumption of animal proteins in the emerging economies. Worldwide, biobased products in health and wellness and chemicals/plastic sectors are finding a growing acceptability due to environmental and health concerns. The market for the livestock health and nutrition range (LHN) products is estimated to be at over Rs 10000 crore in South and South East Asia, slated to grow at CAGR of 10 %. Major segments are Vital Nutrition, Pre and Probiotics, Enzymes and Disease preventing products. Keeping that in view, in the first phase, Praj will target the Indian market followed by growing markets overseas. The sheer growth potential globally gives us confidence that we have entered into this area at the right time. Q: How do you look at importance of collaborations? These days one cannot say that I will go solo and achieve what I want. Partnerships are very important and realizing that, we have collaborated in past with Institute of Chemical Technologies, Mumbai; National Chemical Laboratory (NCL), Pune; and Indian Institute of Technology (IIT), Mumbai. Presently are also looking at a project with Dy Patil College though as of yet it is in nascent stage. We have also partnered with many foreign organizations. We are always open for partners both nationally as well as abroad for joint development that comes with benefit of intellectual property access. Q: Which are your key strategies for expansion? Praj is seeking strategic partners with global outlook in industrial biotechnology. That includes the sustainable access to feedstock streams, insights into consumer markets and application development expertise. The partnerships have to be on technology and commercial risk sharing ability focusing on long term economic gains. What we require are the transparent long term relationships for further development. Q: What is your outlook of the company for next five years? A lot has to be done before we can say that we have achieved the milestones we set for ourselves when we embarked on our turnaround plans in 2010. Going forth, we need to transform ourselves. From being predominantly a project led company to a products and services company, as well. From being a single vertical business to being a solutions provider to multiple industries; connecting with the masses, touching lives through our many offerings; from being a global Indian company to a true-blue global organization. Hence no doubt we will be a major player in the industrial biotech field in few years from now. Talking about the expected revenue stream, suppose if we look at a pie of hundred, the 25-30 percent will come from R&D driven outcomes, nearly 35-40 of the revenue of the company from emerging businesses such as water and wastewater treatment, critical processes and equipments, pharma systems, etc. Finally, the 20-25 percent revenue is expected to come from traditional businesses such as ethanol and beer. These are the three major buckets which we are looking at. And the fourth one is from our future developments in bioproducts. Q: What do you think about the overall growth of the industry? What are the overall challenges before it? The growth of the overall industry has been slow as the market growth has been dependent on many factors. There has to be public private partnerships in variety of projects, be it with government or foreign companies. Among the major challenges are the uncertainty in business environment, economic scenario that has deteriorated of late and also the customers facing regulatory hassles at regular intervals. The framework is not there and the industry has not received the due attention from the government which could have helped in fast-tracking its progress in many ways. Q: What kind of bioenergy market do you foresee in Indian context? Today 70 percent of the oil is being imported into the country. Out of our total basket of petrol, 10 percent of ethanol blending into petrol that we aim at, will be close to 2 billion litres of ethanol. It is a huge quantity for us here in India but countries like Brazil have already gone upto 80 percent with flex fuel vehicles. We are converting a lot of wastwater into biogas. It has got tremendous applications such as creation of power and cooking gas for domestic consumption. Infact ,we are sitting on great opportunity as a country but only if we have right policies, scope is tremendous. Being part of various industry associations, we have been pushing the government to start looking at it and now we can see the things moving on ground. It is yet an early stage for the bioenergy here in India but we are catching up fast. ]]> <![CDATA[Mobile Healthcare pitching in to improve cost-efficiency]]> https://biospectrumindia.com/news/95/4498/mobile-healthcare-pitching-in-to-improve-cost-efficiency.html https://biospectrumindia.com/news/95/4498/mobile-healthcare-pitching-in-to-improve-cost-efficiency.html Wed, 09 Oct 2013 17:27:00 +0530 Bharat Book Bureau presents The Mobile Healthcare (mHealth): 2014-2020, with more than seven billion mobile network subscriptions worldwide, the mobile communications sector is rapidly gaining traction from a diverse range of vertical sectors. As Healthcare providers seek to maximize their patient outreach, while minimizing costs, many view mobile healthcare (or mhealth) as the solution to improve healthcare cost-efficiency. mHealth refers to the usage of mobile communications technology and devices to enhance access to healthcare information, improve distribution of routine and emergency health services and provide diagnostic services. Mobile network operators also view mHealth as a lucrative opportunity fr the monetization of their mobile connectivity services. Given that most operators have established themselves as reputable consumer brands, they are also eying on opportunities to offer services beyond simple connectivity. Many operators already offer branded or co-branded end-to-end mHealth solutions to their customer bases. In addition, mHealth offers a multitude to opportunities to the pharmaceutical industry ranging from R&D activities to securing the supply chain and, in the battle against counterfeit drugs. Driven by thriving ecosystem, SNS research estimates that the mHealth market will account for nearly $9 billion in 2014 alone. Despite barriers relating to regulation, patient acceptance and privacy concerns, SNS Research estimates further growth at a CAGR of nearly 40% over the next 6 years. This reports presents an in-depth assessment of the global mHealth market. in addition to covering key market divers, challenges, future road-map, value chain analysis, deployment case studies, service/product strategies and strategic recommendations, the report also presents comprehensive forecasts for the mHealth market from 2013 till 2020. ]]> <![CDATA[Shailesh Ayyangar takes over as OPPI president]]> https://biospectrumindia.com/news/95/3913/shailesh-ayyangar-takes-over-as-oppi-president.html https://biospectrumindia.com/news/95/3913/shailesh-ayyangar-takes-over-as-oppi-president.html Wed, 09 Oct 2013 10:57:00 +0530 With the aim of encouraging innovation in India, Organisation of Pharmaceutical Producers of India (OPPI) has instituted, as public private partnership initiative along with NIPER and CSIR, OPPI Scientists and Young Scientists Awards. "Access to innovative medicines can change the health of a nation. As an industry, we are committed to delivering innovative medicines that address the unmet medical needs of India. We urge the government to offer greater IPR protection to pharmaceutical companies to encourage continued efforts towards drug discovery and development needed to combat diseases," said Mr. Christopher Viehbacher, President, EFPIA (European federation of Pharmaceutical industries and associations) and CEO Sanofi, at the 47th AGM of the OPPI. Viebacher referred to the Millennium Development Goals (MDG) set by the UN for 2015 and said, "While India had made remarkable strides in reducing child mortality; what would further help India realize its vision for universal healthcare is an enabling environment and policy framework, with partnerships, open dialogue and transparency amongst public and private stakeholders." Mr Tapan Ray, Director General OPPI announced the election of Dr Shailesh Ayyangar, Managing Director - India and Vice President, South Asia, Sanofi India Ltd as the new President of OPPI and Mr Sudarshan Jain, Managing Director, Healthcare Solutions, Abbott Healthcare Pvt Ltd; Mr Pheroze Khan, Managing Director, Bristol-Myers Squibb India Pvt Ltd, Mr Aijaz Tobaccowalla, Managing Director, Pfizer Ltd and Mr Lawrence Ganti, GM India, Merck Ltd. (Merck Serono) as the Vice Presidents. Dr Shailesh Ayyangar, Incoming President OPPI said "I am honored to have been nominated by my colleagues to be the President of the OPPI for the year 2013-2014." "We are at a historic crossroads where future generations would judge us by the actions we take today to improve healthcare access for the vast population of our country. Along with my colleagues in OPPI, we will join hands with all stakeholders - Government in State and Center, NGO's engaged in Healthcare issues, healthcare providers, industry colleagues and academic institutions - to create an ecosystem of innovation and quality in our country to serve our number one priority - the patients of India" Dr Ayyangar added. Present at the meeting were Mr Dilsher Singh Kalha, Secretary Department of Pharmaceuticals (DOP) as the Guest of honor and MD, CEO and top executives of Pharmaceutical Companies, key opinion leaders, senior government officials, experts and media persons. Also the awards were given to encourage original research and innovation in the field of Pharmaceutical Sciences in India. This year's winners were:- Best Scientist Award (CSIR): Dr Gangadhar J Sanjayan, National Chemical Laboratory (NCL) Pune- Best Scientist Award (Academic Institute): Dr Ellora Sen, National Brain Research Centre, Haryana- Best Scientist Awards (Pharma Research Center): Dr Prabhu Datt Mishra, Piramal Enterprises Ltd, Mumbai ]]> <![CDATA[Three share Nobel Prize 2013]]> https://biospectrumindia.com/news/95/3464/three-share-nobel-prize-2013.html https://biospectrumindia.com/news/95/3464/three-share-nobel-prize-2013.html Tue, 08 Oct 2013 17:50:00 +0530 The three Nobel Laureates from US have discovered the molecular principles that govern how molecules like hormones, and neurotransmitters are delivered to the right place at the right time around the cell, through small packages called vesicles. Randy W Schekman, 64, professor, department of molecular and cell biology, University of California at Berkeley, discovered a set of genes that were required for vesicle traffic. James E Rothman, 62, professor and chairman, department of cell biology, Yale University, unravelled protein machinery that allows vesicles to fuse with their targets to permit transfer of cargo. And German-born Thomas C SÃ¼dhof, 57, professor of molecular and cellular physiology, Stanford University, revealed how signals instruct vesicles to release their cargo with precision. The three laureates' work spanning over the last four decades, made pioneering research on understanding how tiny bubbles called vesicles act as cargo carriers inside cells. Through their discoveries, Rothman, Schekman and SÃ¼dhof have revealed the precise control system for the transport and delivery of cellular cargo. Disturbances in this system have deleterious effects and contribute to conditions such as neurological diseases, diabetes, and immunological disorders. The three Nobel Laureates' have discovered a fundamental process in cell physiology. These discoveries has a major impact on our understanding of how cargo is delivered with timing and precision within and outside the cell. ]]> <![CDATA[CIMS and UBM Medica India successfully conduct the 2nd INDIAN PHARMA EXPO ]]> https://biospectrumindia.com/news/95/8225/cims-and-ubm-medica-india-successfully-conduct-the-2nd-indian-pharma-expo-.html https://biospectrumindia.com/news/95/8225/cims-and-ubm-medica-india-successfully-conduct-the-2nd-indian-pharma-expo-.html Tue, 08 Oct 2013 17:34:45 +0530 The expo was conducted in association with Invision Medi Sciences Pvt. Ltd. (Platinum Partner), Biochemix (Gold Partner) & State Bank of India (Banking Partner), supported by DM Pharma, EPS Worldwide and Southern Travels/Hotel Southern were the Logistics Partner and Travel Partner respectively. Aimed at bringing together all the Pharma professionals under one roof, the exhibition held in September at famous Prgati Maidan at New Delhi, witnessed 66 Exhibitors & more than 5300 + Visitors including a lot of International footfall from countries like Australia, Malaysia, Philippines, Africa, Singapore and many more in a span of two days. The show is developing, proving its high effectiveness and importance. The opening ceremony of IPE-2013 was graced by Dr. Monica Bhatia (MD, UBM Medica India Pvt. Ltd.), Chief Guest- Dr. (Mrs.) Shobha Vijender (Founder President, Sampurna-N.G.O), Guest of Honors-Mr. Atul Nasa, (President-IPGA, IPCA and Vice-President-AIDCOC, also associated with Drug Control Department, Delhi), Mr. S. L. Nasa (President-IHPA, Registrar-Delhi Pharmacy Council) and Mr. Kailash Gupta (President-AICDF as well as Bhartiya Udyog Vayapar Mandal) and eminent members of AIOCD and RDCA. The event was supported by various associations, such as CIPI, AIOCD, AICDF, Pharmexil, Mumbai Pharma Association, Navi Mumbai Retail Chemists & Wholesaler association. The media partners of IPE-2013 were Pharmaceutical-Tech, Express Pharma, Conference locate.com, Icpc.biz (Indo China Pharma Chem), BioSpectrum, Medexpo Africa 2013, Proven Trade Contacts and Medical Events. With the advantage of the leading market brands CIMS/ IDR/cimsasia.com/ Clinical Assist, JPOG and the Today series of journals, which were diligently built over the course of four decades, IPE is the platform for high level business opportunities for all related to healthcare industry. "Face to Face contact is an effective and crucial factor for building and maintaining business. The success of Indian Pharma Expo2013 is characterized by personal interactions with potential and existing customers. This expo proved to be an idealPlace to network and enhance relationships with key visitors. We provided a perfect platform which resulted in secured business deals within a highly professional business atmosphere," said Dr. Monica Bhatia, MD, UBM Medica India. ]]> <![CDATA[Royal Philips' new hospital to home business in Asia Pacific]]> https://biospectrumindia.com/news/95/3462/royal-philips-new-hospital-to-home-business-in-asia-pacific.html https://biospectrumindia.com/news/95/3462/royal-philips-new-hospital-to-home-business-in-asia-pacific.html Tue, 08 Oct 2013 11:39:00 +0530 Royal Philips announced that it is introducing healthcare innovations that will help health systems in Asia to address the growing challenges linked to a fast growing and aging population. Philips' new hospital to home business in Asia Pacific will seek to improve care transitions by offering re-admission management consulting for greater care continuity, and a personal health portal to engage patients and their families in their own health. "By realizing Hospital to Home solutions that are relevant to the local care ecosystem, we will bridge the hospital and the home for a truly patient-centered care model," said Frans van Houten, CEO Royal Philips. "In the Asia Pacific region, Singapore is seen as a reference site for its healthcare system and therefore an ideal location to establish the regional headquarters for this new business. Together with the local stakeholders, we will develop patient care models for the region that will enhance patient outcomes beyond hospital." Mr Leo Yip, Chairman of the Singapore Economic Development Board, said: "We are delighted that philips has chosen Singapore as the competence center and regional headquarters for its new hospital to home business. This is a good example of how global companies like Philips Find value in Singapore as a partner and in our ICT capabilities to co-innovate and develop new healthcare solutions here, which can then be marketed to the rest of Asia." "Emphasis on shared ownership and joint responsibility for healthcare outcomes is a core principle of the Singaporean healthcare system, said Fernando Erazo, Head of Hospital to Home, Philips Healthcare in Asia Pacific. ]]> <![CDATA[Piramal Enterprises laud with five star safety ratings]]> https://biospectrumindia.com/news/95/8193/piramal-enterprises-laud-with-five-star-safety-ratings.html https://biospectrumindia.com/news/95/8193/piramal-enterprises-laud-with-five-star-safety-ratings.html Tue, 08 Oct 2013 11:31:00 +0530 Piramal Enterprises achieved the British safety Council (BSC) Five-Star Safety award for the Digwal pharma solution's site, near Hyderabad. This award recognizes the company's adherence to world class safety and compliance with the best industry practices worldwide. Commenting on the appreciation Mr. Vijay Shah, Executive Director And COO Piramal Enterprises said, "At Piramal, Environment, Health and Safety (EHS) is embedded in our very philosophy of business. The Digwal site underwent a stringent 4 day audit from 12th to 16th August, 2013 led by a delegate from British Safety Council (BSC), UK. I'm happy to note that the audit results declared in the month of September, 2013 scored Digwal site at a commendable 94.58%. The five star award of BSC, is highly reputed and is awarded in recognition of world class safety practices." The British Safety Council audit is an internationally recognized system, used by leading organizations worldwide to benchmark their health, safety and environment (HSE) management systems against the best practices. The 5-star audit concentrates on five sections, safety organization, management control system organization, management control system, fire control systems, measurement and control systems and workplace implementation. Mr Shah added, "We are the only Indian Pharma company this year to have received this prestigious award. This indeed is noteworthy." Piramal's high score credits the site with a 5-star rating which is a world-class benchmark standard. Among many other areas of strength in Piramal's safety management system. ]]> <![CDATA[An initiative to fight diabetes among children in India]]> https://biospectrumindia.com/news/95/5782/an-initiative-to-fight-diabetes-among-children-in-india.html https://biospectrumindia.com/news/95/5782/an-initiative-to-fight-diabetes-among-children-in-india.html Tue, 08 Oct 2013 11:10:05 +0530 In India, diabetes is one of the major public health challenge and it is ranked at no. 2 globally. While Type 2 diabetes has received considerable attention in interventions, it has not been so for juvenile or type 1 diabetes, though 1 out of 5 children with Type 1 diabetes in the world would be an Indian. If Type 1 diabetes is not detected and diagnosed, it could pose a grave challenge for children and families, who need adequate knowledge and resources for effective management of the condition. Sanofi, the International Diabetes Federation (IDF) and Public health Foundation of India (PHFI) announced their first joint public health initiative in India, KiDS. For the children with Type 1 diabetes, the project aims to encourage a safe and supportive school environment to manage their diabetes and avoid discrimination. In addition, the program will raise awareness on diabetes (Type 1 and Type 2) and benefits of healthy nutrition and exercise habits among school children. Launching the KiDS project in Mumbai, Chris Viehbacher, Chief Executive Officer, Sanofi stated "As a global leader in diabetes care, we focus on bringing real benefits to people with diabetes, not just providing a comprehensive portfolio of treatments and innovative patient friendly devices but also accompanying them in their daily life. With close support, we can really make a difference in patient outcomes so we are very committed to partnering with key stakeholders to create the best patient support programs possible." "In a developing country like India, barriers to diabetes self-management at school are significant" said Michael Hirst, President of IDF. "By engaging with policy makers and education authorities, organizing meeting in local communities and providing educational resources to school." Dr K Srinath, President - PHFI shared that "The program's first step was a feasibility study to understand the status of diabetes management by reviewing current policies on diabetes in schools, existing school guidelines and initiatives, any best practices - and identify gaps in the knowledge so that appropriate resources and dissemination routes can be developed. We found that there are no structured training programs, plan or activity, implemented in the school settings that focus on diabetes management." ]]> <![CDATA[India finally realizes its indigenous JE vaccine dream]]> https://biospectrumindia.com/news/95/5838/india-finally-realizes-its-indigenous-je-vaccine-dream.html https://biospectrumindia.com/news/95/5838/india-finally-realizes-its-indigenous-je-vaccine-dream.html Mon, 07 Oct 2013 16:06:00 +0530 The first indigenous vaccine against Japanese encephalitis, using strain, identified, characterized, manufactured and tested in India, has finally been commercialized. The Vero cell-derived purified inactivated Japanese encephalitis vaccine-JENVAC from Hyderabad based Bharat Biotech, is being termed as a great alternative to the existing cheap vaccines being imported so far from China. The vaccine approved by the Drug Controller General of India, pioneers as the first vaccine ever to be manufactured in a public-private collaboration. The vaccine aims to provide better immunogenicity and long term protection owing to unique manufacturing technologies. Japanese encephalitis is the most common cause of viral encephalitis in Asia-Pacific. It causes inflammation of the brain, symptoms include high fever, headache, sensitivity to light, stiff neck and back, vomiting, confusion and, in severe cases, seizures, paralysis and coma. The disease which is transmitted via mosquitoes, with pigs and water birds acting as amplifying hosts for the virus, is the leading cause of viral encephalitis in Asia with ~ 50,000 clinical cases reported annually. In India, the disease affects close to 171 districts and claims hundreds of lives each year, especially in Goarkhpur district of Uttar Pradesh. The biggest advantage of JENVAC over live attenuated vaccines is that this vaccine could be administered even during an epidemic as it is an extremely purified and inactivated vaccine.In the clinical trials JENVAC showed superior safety and immunogenicity, in head to head comparison with the live SA14-14-2 vaccine. The vaccine met all its primary and secondary endpoints, in the age group of 1 to 50 years, after 1 or 2 doses of vaccination. Phase III trials showed 98.7% sero-protection 28 days after the 1st dose and 99.8% sero-protection 28 days after dose the 2nd dose. The results proved that JENVAC can be administered as a single dose during epidemics for mass vaccination campaigns and also as a 2 dose schedule during routine immunization as part of the National Immunization program in endemic regions Bharat Biotech is looking at a dual pricing strategy for JENVAC, so as to cater to both public and private agencies. While the anticipated price is said to be between Rs 140 to Rs 160/- per dose in private market, the government price is still in negotiation. Speaking on the occasion, Dr Krishna Ella, chairman and managing director, Bharat Biotech expressed his satisfaction over success of the project which he termed a political as well as social commitment. "I am overwhelmed at the successful culmination of an idea and its execution over the period of time. Equally satisfying has been the role played by the government agencies and regulators in ensuring that this vaccine becomes a reality," mentioned Dr Ella. "JENVAC has the potential to reduce disease burden and reduce India's import of JE vaccines. Bharat Biotech has a long history of developing novel health care solutions through public private partnerships, we hope to continue the same in years to come," he added further. Describing the vaccine as an "Indian solution for an Indian problem", Union Health and Family Welfare Minister Ghulam Nabi Azad said this completely indigenous vaccine was an outstanding example of public-private partnership and a remarkable milestone in the emergence of India as an innovative and self-sufficient technology hub. Dr V M Katoch, secretary, Department of Health Research, Govt of India, said " JENVAC not only represents as a successful example of developing a totally Indian product of immense public health importance by public -private partnership but also will prove to be a good stimulus to ICMR institutes and other institutions to move fast with their leads to fully developed products by following this route" ]]> <![CDATA[Now make French fries and Ketch-up from the same plant!]]> https://biospectrumindia.com/news/95/8019/now-make-french-fries-and-ketch-up-from-the-same-plant.html https://biospectrumindia.com/news/95/8019/now-make-french-fries-and-ketch-up-from-the-same-plant.html Fri, 04 Oct 2013 18:32:00 +0530 This real hybrid plant variety called as 'TomTato', has been developed by Thompson & Morgan, a UK-based seed and plant company. TomTato is a grafted plant, giving out tomatoes on top and potatoes underneath the ground. This hybrid is simply produced by grafting a tomato and potato plant together, which is already common amongst many crops, such as roses and fruit trees. Talking about the research behind creating this Frankensteinian hybrid plant, Mr Michael Perry, new product manager, Thompson & Morgan, told BioSpectrum, "We investigated professional grafting companies for a few years before finding a company we trusted in carrying out the technical grafting process. Once we had this, we trialed a range of varieties to make sure we had 2 compatible varieties." The TomTato hybrid has been a success as both, potato and tomato, are close relatives, descending from the same plant family and having same number of chromosomes. TomTato is said to be easily cultivable either in containers or in the open ground just as any other tomato plant. They can be grown in any climate that potatoes and tomatoes are usually grown in. Mr Perry said that these hybrid crops are identical to the usual tomatoes and potatoes, and that the crops have been certified to be safe for human consumption. TomTato plant takes 4 months to produce tomatoes and about 5 months for potatoes from the time of planting. Mr Perry assured that there were no genetic modifications carried out in the creation of TomTato. Currently, TomTato is available by mail order only in the UK, priced at £14.99 each. ]]> <![CDATA[Emergency Medicine should be a specialty in India: Dr Mabel Vasnaik]]> https://biospectrumindia.com/interviews/95/3460/emergency-medicine-should-be-a-specialty-in-india-dr-mabel-vasnaik.html https://biospectrumindia.com/interviews/95/3460/emergency-medicine-should-be-a-specialty-in-india-dr-mabel-vasnaik.html Fri, 04 Oct 2013 16:17:00 +0530 What are the major challenges in handling medical emergencies in Indian hospitals?Dr Mabel Vasnaik: When you have an emergency, you need to go to the emergency department. But in India, we have casualty wards manned by junior doctors, instead of having a fully-equipped emergency department run by professionals. That's a challenge. In countries like US and UK, Emergency Medicine in itself is a specialty and it should be the same in India as well. Their hospitals will have an exclusive emergency department run by fully qualified professionals. In India, medical education in Emergency Medicine began only 2 years ago, which was recognized by Medical Council of India. Doctors who are qualified in handling emergencies will know how to thoroughly examine from tip-to-toe. Initially, the government was ignorant. However, with the intervention of Medical Council of India, we now have a separate course in Emergency Medicine. The government has to be made more aware in this regard. How is medical emergency handling in India different from other countries like the US and UK?In the west, they employ trained emergency physicians in the emergency department as opposed to us, who employ junior doctors. They will have round-the-clock, fully-manned, emergency department. When you are in a crisis, you'd want to go to a qualified professional who has been trained to handle emergencies. To begin with, people need to be trained in basic first aid since most of them don't know what to do in a medical emergency. In India, most first aid boxes are found to be empty with nothing inside it. They also should have an awareness about ambulance services like '108'. The issue is, even the basic things are not very sound in our society. What is the basic advice that you would offer to a layman in an emergency situation?The first thing is not to panic. If you know to give first aid, then proceed with it. Then call for help, either your neighbors or an ambulance. Assess the patient's condition and do not offer him or her any food or drink. If it is a bleeding, try to stop it. And take the patient to the nearest hospital. Are we facing shortage of human resources in Emergency Medicine?There is no dearth of human resources. Rather, there is lack of training and development of qualified professionals. We can start teaching first aid implementation beginning from class 7 or class 10. Sadly, we do not do it in schools, colleges, and even in corporates. We lack in the number of trained people who know how to handle emergencies. We need to start training people as they are willing to be trained. We just need to open up more. How can we bring about attitudinal change in the minds of people to attend a medical emergency?Whatever help you offer in an emergency situation is far better than nothing at all. The hospitals should not retain or withhold people who bring in patients in medical emergency crisis. Most people fear about medico-legal complications that they might have to face if they offer a helping hand. But people will come forward to help, once they are educated in handling emergencies. ]]> <![CDATA[Movers and Shakers of the healthcare Industry awarded]]> https://biospectrumindia.com/news/95/3461/movers-and-shakers-of-the-healthcare-industry-awarded.html https://biospectrumindia.com/news/95/3461/movers-and-shakers-of-the-healthcare-industry-awarded.html Fri, 04 Oct 2013 11:51:00 +0530 The Frost and Sullivan 5th Annual India Healthcare Excellence Awards - 2013 among the presence of stalwarts of healthcare industry honored the outstanding contribution and dedication of healthcare companies from all over India. In a partner speak Mr S.R Dugal, Group Chairman ICRI commented "In past 7 years industry has gone through a robust growth and change. Today patient has got the choice and that is big revolution. Pacing the patient in the center is the big change and huge determining factor in terms of development in the healthcare industry. When there is widespread of market it means everything is accessible." Similarly speaking on the occasion Dr. Anil Munniyappa, Presales Consultant, Wipro Healthcare opined "Being an IT company it has been a continuous learning process for us to be in healthcare. Our presence in healthcare is in terms of providing consulting and infrastructure." The awards were categorised in medical diagnostics, healthcare delivery and pharmaceuticals. The jury members on board made the awards a successful event by rightly recongnizing the excellence of the companies. The scintillating evening saw a marvelous entertaining dance form of Egypt which enthralled the audience and kept the octane level at all time high. The winners of the coveted frost and Sullivan 5th Annual India Healthcare Excellence Awards 2013 are listed below: - Wellness Service Provider Copmpany of the Year: Indus Health Plus - Hair Restoration Service Provider Company of the Year : DHI Global Leader - Imaging Company of the Year : Philips Healthcare - Pharmacutical brand of the year (new launch) : Trajenta - Indian medical consumables company of the year : Lotus - Emerging bio-pharmaceutical company of the year: Bharat Serums and Vaccines Ltd - Sterilization Service Company of the year: 3M Healthcare - Multinational pharmaceutical company of the year: Abbott - Oral-antidiabetic company of the year: USV Ltd - Dialysis Service provider Company of the year hospital category: Medica SuperSpeciality hospital - Dialysis service provider Company of the year independent centers: B Braun - Healthcare Entrepreneurs of the Year: Nova medical centre -In-Vitro diagnostics company of the year: Roche - IVF service provider company of the year : Bloom IVF centre - Healthcare service provider company of the year (revenue less than INR500 cr): Shalby Hospitals - Healthcare service provider company of the year (revenue between INR500-1000cr): Medanta, The Medicity - Healthcare service provider company of the year (revenue above INR 1000cr): Apollo Hospitals - Dialysis solutions company of the year: Fresenius Medical Care - Promising Pharmaceutical R&D Company of the year: Sun Pharmaceutical Industries Ltd - Diagnostic service provider company of the year: SRL diagnostics - Emerging Medical equipment company of the year: Piramal Healthcare ]]> <![CDATA[USV Limited honored with Oral Anti-Diabetic Company of the Year 2013]]> https://biospectrumindia.com/news/95/4765/usv-limited-honored-with-oral-anti-diabetic-company-of-the-year-2013.html https://biospectrumindia.com/news/95/4765/usv-limited-honored-with-oral-anti-diabetic-company-of-the-year-2013.html Fri, 04 Oct 2013 11:49:56 +0530 USV Limited won the Oral Anti-Diabetic Company of the Year 2013 Award at the Frost and Sullivan's 5th Annual India Healthcare Excellence Awards 2013. Mr. Prashant Tewari, MD, USV Limited, said. "To be honored with the Oral Anti-Diabetes Awards demonstrates the consistent and innovative ability of USV to develop and market significant diabetes products, which greatly assist patients, while also having great comercial potential. This award marks another milestone for USV." "Understanding the needs of the Indian diabetes population and then meeting those needs with innovative and practical products has been USV's aim. It is a proud moment for us to be recongnized by Frost and Sullivan for this daily pursuit," Mr. Tewari added. Congratulating USV limited on the award, Jayant Singh, Associate Director, Pharma and Medical Technology, Healthcare Practice, Frost and Sullivan, expressed, "Based on our annual voice of customer research, active patient centric initiatives has made USV limited one of the leading and most recongnized companies in the oral-antidiabetic segment in India." ]]> <![CDATA[Jubilant Life Sciences recieves 'Excellence Award' from UP Govt]]> https://biospectrumindia.com/news/95/5436/jubilant-life-sciences-recieves-excellence-award-from-up-govt.html https://biospectrumindia.com/news/95/5436/jubilant-life-sciences-recieves-excellence-award-from-up-govt.html Thu, 03 Oct 2013 18:06:00 +0530 Jubilant Life Sciences has been awarded in two categories with prestigious Shri Janeshwar Mishra Export Awards. The two awards recognise the exceptional work undertaken by Jubilant at its manufacturing facility in Gajraula, District Amroha, Uttar Pradesh (UP). The awards received by Jubilant Life Sciences includes an 'Excellence Award' and a 'First Award' for its performance in the field of Export under the category of Chemicals , Pharmaceuticals and Cosmetics for the year 2011-12. The awards are felicitated by the Export Promotion Bureau, Department of MSME, government of Uttar Pradesh every year to acknowledge individual and organisations across the Uttar Pradesh that demonstrates excellence in their work or activities. The two awards were received by Mr Shyam Bang, Executive Director, Manufacturing and Supply Chain, Jubilant Life Sciences on behalf of the company. "I am delighted and honoured to receive the awards. I will attribute this recognition to all our employees at our plant in Gajraula and to our valued customers spread across the globe. This achievement has inspired our people to deliver quality performance, today and forever, and provide best results to our customers," expressed Mr Shyam Bang, Executive Director, Manufacturing & Supply Chain, Jubilant Life Sciences. Dignitaries present on the occasion were Mr Bhagwat Singh Gangwar, State Minister for MSME and Export Promotion, Mr. Mukul Singhal, IAS Principal Secretary MSME & Export Promotion and Mr Mahesh Chandra Gupta, IAS Commissioner & Director of Industries, Government of Uttar Pradesh. ]]> <![CDATA[Govt proposes Rs 500 crore fund for agricultural research ]]> https://biospectrumindia.com/news/95/3262/govt-proposes-rs-500-crore-fund-for-agricultural-research-.html https://biospectrumindia.com/news/95/3262/govt-proposes-rs-500-crore-fund-for-agricultural-research-.html Thu, 03 Oct 2013 17:24:56 +0530 The Indian National Agricultural Research System (NARS) has to find solutions to the immediate problems of farming as well as keep its competence in technology development in the forefront to meet all continuously emerging anticipated and unanticipated problems. For this continuous strengthening of basic and strategic research and, applied research in the frontier areas of agricultural sciences is required. Fully realising this need, the government of India decided to establish a national fund for supporting basic and strategic research under the Indian Council for Agricultural Research (ICAR) with the objective to build capacity for basic and strategic research of national and long-term importance to break yield and quality barriers and make India a global leader in research for development, through the partnership of all research organizations who can contribute towards this objective. The fund was initiated during the tenth five year plan (for the year 2006-2007 only) with an outlay of Rs 50 crore. Twenty one projects were approved during the 10th Plan. In view of its strategic importance, the fund continued during the eleventh five year plan (2007-2012) with an outlay of Rs 100 crore. During eleventh plan, twenty two new projects were approved. It is highly likely to continue in the twelth Five Year Plan (2012-2017). The proposed budget for the plan is Rs 500 crore. The fund strongly encourages collaborative and multi-institutional research based on innovative ideas of scientists for solving advanced scientific and technological problems in agriculture. Scientists from all research institutions universities and private sector with proven research capacity and located in India are eligible to participate. ]]> <![CDATA[Bangalore INDIA BIO 2014: India becoming a credible biotechnology destination, Dr Kiran Mazumdar]]> https://biospectrumindia.com/news/95/4469/bangalore-india-bio-2014-india-becoming-a-credible-biotechnology-destination-dr-kiran-mazumdar.html https://biospectrumindia.com/news/95/4469/bangalore-india-bio-2014-india-becoming-a-credible-biotechnology-destination-dr-kiran-mazumdar.html Mon, 30 Sep 2013 19:20:00 +0530 The Department of Information Technology, Biotechnology and Science & Technology, Government of Karnataka, Vision Group on Biotechnology and MM Activ Sci-Tech Communications on September 27th, 2013, announced that Bangalore INDIA BIO (BIB) 2014, with the core theme, 'Biotech for a Better Tomorrow', will be held from February 10-12, 2014, at The Lalit Ashok, Bangalore. The announcement was made by Shri S R Patil, Hon'ble Minister for IT, Biotech and S&T, Planning and Statistics, Government of Karnataka, in the presence of Dr Kiran Mazumdar-shaw, Chairperson, Karnataka's Vision Group on Biotechnology & CMD, Biocon Ltd., Mr Srivatsa Krishna, IAS, Secretary to Government, Department of Information Technology, Biotechnology and Science & Technology and industry representatives. Dr Kiran Mazumdar-Shaw addressed the gathering by speaking on the future prospects of biotech industry. She said, "Biotechnology, for a country like India, ensures food security, health security and energy security. Environmental sustainability is something that is gaining a lot of momentum. Bangalore is at an advantageous position in this sector. I believe that the biotech sector has been handcuffed and made to run on regulations which has been very draconian, and we need to fight for regulatory norms that allows us to build this sector." Nobel Laureate Sir John Bertrand Gurdon will deliver a distinguished lecture at this much awaited India's biggest biotech show. Also, 2013's World Food Prize Laureate Em. Prof Marc Van Montagu, Founder and Chairman, Institute for Plant Biotechnology Outreach (IPBO), Belgium, will address the gathering. Mr Srivatsa Krishna added that today's biotechnology can become the IT of tomorrow. He said, "Karnataka is India's IT and biotech capital. The IT industry in India today is worth Rs 6.43 lakh crore and the biotech industry in comparison is Rs 23,500 crore. I see no reason why today's biotechnology can't become the IT of tomorrow. IT has a road map which the biotech industry can emulate and exceed." Shri S R Patil added that this flagship event will provide institutes, organizations and companies to showcase their services. "The biotech sector in Karnataka enjoys a comfortable position in terms of revenues. The state is home to about 52 percent of pure biotechnology companies. Out of the top ten biotechnology companies in India, five of them are located in Bangalore. The IT capital has emerged as the science capital of India. Thanks to the biotechnology sector." Dr Kiran believes that biotech has the power to be the second green revolution for our economy. She said, "It will address profitability challenges among others that farmers face in terms of financial viability. India has clearly become the vaccine hub of the world and we can become the hub for biologics as well. Biotechnology addresses our large unmet medical needs. What conventional Allopathic medicine has not addressed till date, many immunological and chronic diseases like cancer and diabetes, is now being addressed by biotechnology. Biotech has played a phenomenal role in addressing cancer and auto-immune diseases, which has led to a cure which could not be imagined before." Mr Patil further expressed, "Our focus now is on building necessary human resources and infrastructure for the biotech industry. This event will provide an opportunity for students pursuing biotechnology as a career. The youngsters will be inspired by senior and global scientists who will be present at the event. More than any other state, the Karnataka government has invested more in the biotech field. We want to give more importance to bioagriculture to empower farmers' living standards because our economy is dependent on agriculture, which is our backbone." Talking about Karnataka's biotechnology ecosystem, Mr Srivatsa said, "We have some of the finest quality research laboratories which has to be leveraged, and create the same magic like the IT industry." Emphasizing on bioagriculture, he further added, "For every single biotech investment, Bangalore should be the most preferred destination. People in India are sustained by agriculture and farming. Biotechnology offers the hope and promise that nothing else did for many years. Biotech can empower and enable farmers, whose life and livelihood depend on agriculture for a far better life." In the area of biofuels, Dr Kiran pointed out that we have become energy dependent and that reliance on fossil fuels is causing financial strain on the system. She said, "Our current account deficit is also facing problems because of importing fossil fuels. Biofuel is a big area for India. There are many companies looking for harnessing biofuels. There is a lot of untapped sources like algae biomass and bioethanol which has to be considered. This is what will build the bio-economy, which will enable India to address all its present day challenges." Talking about the significance of medical technology, Dr Kiran said, "Medical technology is another important sector where medical care and diagnostics will help diagnose diseases better and bring personalized medical care through the use of technology. Again, Bangalore has the potential of becoming the global hub for biomedical devices and diagnostics. "There are very interesting start-up companies in Bangalore. All the knowledge from medical device companies like GE, Philips and Siemens will enable Bangalore to become an important medical devices destination." She also opined that agri-biotech is pursued on a very different scale in many parts of Karnataka and marine biotechnology will have important focus in the future. Dr Kiran concluded by saying, "This Bangalore INDIA BIO 2014 is going to be an interesting and engaging event, where we expect participants from all over the world, bringing together delegates, experts and companies. We expect to have a large number of eminent speakers, making this event a big success. India is becoming a very credible biotechnology destination and it has a great role to play. We'll develop a strong leadership position in the biotech industry in every aspect of what it has to offer." The Bangalore INDIA BIO 2014 will host multi-track conferences, international tradeshow, distinguished lectures and talks, interlinX biopartnering, CEO conclave, bio excellence awards, bioquiz and other networking events. The conference is expected to have 25 conference sessions, about 100 exhibitors and 3000 plus business visitors. Representatives from nearly 15 countries are also anticipated to attend this event. ]]> <![CDATA[Eli Lilly's Project Veeva wins OPPI Sales Force Excellence Award 2013]]> https://biospectrumindia.com/news/95/7714/eli-lillys-project-veeva-wins-oppi-sales-force-excellence-award-2013.html https://biospectrumindia.com/news/95/7714/eli-lillys-project-veeva-wins-oppi-sales-force-excellence-award-2013.html Mon, 30 Sep 2013 16:59:51 +0530 Eli Lilly and company India, the leading innovation based pharmaceutical player, was felicitated with the prestigious OPPI Sales Force Excellence award 2013 for its Project Veeva, aimed at delivering unparalleled customer experience by empowering the sales force. OPPI - Organization of Pharmaceutical Producers of India, instituted these awards to promote excellence in pharmaceutical selling in 2012. Lilly India was conferred with the honor at OPPI's AGM held in Mumbai. The prestigious award came in as recognition of the company's initiative to empower its sales force for delivering unparalleled customer experience and for flawless execution of Project Veeva. The project was designed to empower the sales team of approximately 300 to be self-dependant through relevant modular tool iPad & compatible CRM system Veeva. The system helped enhance customer interaction by leveraging multimedia platform, real time reporting, well documented coaching reports & using advanced analytics to eliminate the struggle of the sales representative for doctor's attention. The system also adequately equipped the sales representatives with micro details to monitor each SFE metric leading to efficient and effective planning. Much-coveted OPPI award was bagged by the project for achieving remarkable success and flawless execution of the project while carefully aligning the sales function with all other relevant functions and accordingly implementing Organization Change Management (OCM). Commenting on this achievement, Mr. Edgard Olaizola, Managing Director, Lilly India said, "It is a great honor for Lilly India to receive this recognition for our project Veeva. At Lilly it is our mission to establish best practices for functional excellence and for creating customer delight. I would like to congratulate our sales team and the Project Veeva team for this prestigious honor. This award is a testimonial to the team's vigour and zeal and the company's customer centricity." ]]> <![CDATA[Nobel Laureate Sir John Bertrand Gurdon to deliver lecture at Bangalore INDIA BIO 2014]]> https://biospectrumindia.com/news/95/5410/nobel-laureate-sir-john-bertrand-gurdon-to-deliver-lecture-at-bangalore-india-bio-2014.html https://biospectrumindia.com/news/95/5410/nobel-laureate-sir-john-bertrand-gurdon-to-deliver-lecture-at-bangalore-india-bio-2014.html Sat, 28 Sep 2013 01:48:00 +0530 The department of Information Technology, Biotechnology and Science & Technology, Government of Karnataka, Vision Group on Biotechnology and MM Activ Sci-Tech Communications on September 27th, 2013, announced that Bangalore INDIA BIO (BIB) 2014 with the core theme, 'Biotech for a Better Tomorrow' will be held from February 10-12, 2014 at The Lalit Ashok, Bangalore. The announcement was made by Shri S R Patil, Hon'ble Minister for IT, BT and S&T, Planning and Statistics, Government of Karnataka, in the presence of Dr Kiran Mazumdar-shaw, Chairperson, Karnataka's Vision Group on Biotechnology & CMD - Biocon Ltd., Mr Srivatsa Krishna, IAS, Secretary to Government, Department of Information Technology, Biotechnology and Science & Technology and industry representatives. The announcement included an overview of the activities planned during Bangalore INDIA BIO 2014 Conference & Exhibition. ]]> <![CDATA[Appollo launches the first ever Personalized Health Check at Apollo Ayanambakkam ]]> https://biospectrumindia.com/news/95/6460/appollo-launches-the-first-ever-personalized-health-check-at-apollo-ayanambakkam-.html https://biospectrumindia.com/news/95/6460/appollo-launches-the-first-ever-personalized-health-check-at-apollo-ayanambakkam-.html Fri, 27 Sep 2013 15:54:09 +0530 'Prevention is better than cure', is something that is preached by one and all, but practiced by a few. A greater awareness of one's health status aided by preventive health check-ups is the best solution rather than reactive healthcare. To this end, popular actor Suriya inaugurated the first ever Apollo Personalized Health Check at Apollo Ayanambakkam in Chennai today. Having pioneered preventive health checks in India - three decades and 8.5 million checks later - Apollo Hospitals has decided to take health checks to the next level. With this inaugural ceremony, Apollo is now also the pioneer of Personalized Health Checks (PHCs) in India.The new health check process will involve a pre-test assessment of an individual's health by a health assessment consultant, based on which a package of tests is designed to cater to the specific needs of the customer. This will be followed by taking samples from the customer and preparation of a detailed report, which in turn will lead to a personalized, consultation by a physician for that individual. Thus, while there will be a core set of tests that are applicable to the particular customer type - based on age and gender, there will also be an additional set of tests unique to the individual as prescribed by the health assessment consultant. "In the panoramic landscape of the country's healthcare needs, there is an ever-widening gap of supply vs. demand of hospital beds. The only way to try and bridge this gap is by preventing disease rather than treating it. Personalized health checks will ensure that the customer gets the most accurate and effective diagnosis that is best suited to his unique needs and in due course, prevent that individual from contracting a disease," said Dr. Prathap C Reddy, Chairman, Apollo Hospitals Group on the occasion. The personalized health checks will result in the best possible medical outcomes for the individual as opposed to a 'one size fits all' master health check. The current process of health checks is more standardized rather than being personalized to a person's unique needs. By the year 2025, a five-fold increase in cancer rates is predicted - 1.5 million new cases will be added every year. Around 80 million people will be affected by diabetes and 60 million people with heart disease. Non-communicable and lifestyle-related diseases are on the rise and will be the cause for 75% of all mortality by the year 2020. Unfortunately, the diseases are contracted long before the patient displays any symptoms. The 3 crucial steps to handling such diseases are prevention, detection and management. ]]> <![CDATA[Azad presents ICMR Awards to 51 scientists ]]> https://biospectrumindia.com/news/95/3416/azad-presents-icmr-awards-to-51-scientists-.html https://biospectrumindia.com/news/95/3416/azad-presents-icmr-awards-to-51-scientists-.html Fri, 27 Sep 2013 15:11:26 +0530 The union minister of health and family welfare, Ghulam Nabi Azad recently presented the ICMR Awards to 51 outstanding clinical and biomedical scientists for the years 2009 and 2010 for their work in communicable and non-communicable diseases, maternal and child health and various other medical and biomedical fields. The JALMA Trust Fund Oration award for 2007 has also been presented this year. While 9 Awardees are from PGI, Chandigarh, 7 from ICMR Institutions, 5 Awardees are from AIIMS and 3 each from DRDO and KGMU, Lucknow, 2 each from NIMHANS, Bangalore, CSIR and Sri Chitra Thirunal Institute of Medical Sciences, Trivandrum and the remaining 18 belong to other Institutions. The ICMR Awards are bestowed based on the quality of knowledge generated, as judged by peers in the scientific field. Speaking at the function, Azad expressed happiness that a good number of the awardees are women scientists. The Health Minister stated that India has been producing excellent human resource in the health field. Applauding the work of the scientists, he said that never before so many projects were taken up and so much research done as has been done in last four years. India produces human resources in the health arena not only for the country's needs, but also for many other countries. Recently at the SEARO meeting in Delhi, the initiatives of Health ministry were appreciated by the Director General of WHO, Dr Margaret Chan, the Minister noted. Azad said that the human resource we produce is being shared with other countries. More than 81,000 doctors/ specialists/ super specialists in USA and more than 75,000 doctors/ specialists/ super specialists in the UK are of Indian origin, he stated. The Health Minister said that the Department of Health Research (DHR) has launched several innovative schemes to expand the research base both in terms of infra-structure and human resource. He stated that during this year itself, DHR has rolled out three new schemes. These schemes aim to establish Multi-disciplinary Research Units in Medical Colleges to considerably strengthen the fight against non-communicable diseases; to establish a network of virology laboratories in all government medical colleges as well as national institutions; and establishment of Model Rural Health Research Units in which ICMR Institutions, State Medical Colleges and State Health Departments will work together and have seamless transfer of modern yet affordable technology for the benefit of rural populace. Highlighting the progress under these three schemes Shri Azad said that in 35 Government medical colleges Multi-disciplinary Research Units will be established in the current year, of which 21 have already been approved. Azad said that 16 new bio-safety laboratories for working on viral diseases and TB have been established during last three years and India now has more than 20 such laboratories.To enhance the capacity for control of outbreaks and other serious viral diseases, the infrastructure for diagnosis and research on viral diseases will be created or strengthened in 160 government medical colleges. Five Model Rural Health Research Units have already been approved by the Department of Health Research. The Health Minister stated that last year a BSL IV laboratory, which is Asia's first active laboratory for Human Medicine was established at NIV, Pune to deal with most dangerous lethal infections like hemorrhagic fevers and agents of bioterrorism. Shri Azad emphasized the work done by the Government in the field of Cancer and Mental Health. Central Government has approved funds for establishing 20 new stand-alone State Cancer Institutes, 23 new Tertiary Cancer Centres and strengthening of existing 27 Regional Cancer Care Centres, across the country. With this initiative, the country will have an additional 70 state of the art tertiary cancer centres in Government sector, when fully established. The Ministry of Health and Family Welfare has launched a programme to encourage development and introduction of affordable and indigenous technologies for public health applications. The country is indigenously developing testing strips for diabetes, work on which is in an advanced stage; along with methods of mosquito control and diagnostic tests for TB, Lung fluke, Dengue, several other infections and cancer. Shri Azad termed the progress as very satisfactory with work on 30 such technologies expected to be completed by 2014. He also stated that research on liver diseases is extremely important considering the enormity of liver diseases of both infectious and non-infectious varieties in India. The Minister of State for Health and Family Welfare, Shri A.H. Khan Choudhary congratulated all the awardees on their outstanding work in the field of research. He said that ICMR is doing a good work and it will go a long way to stimulate young researchers but we need to have more international collaboration in areas which are not fully developed. Shri Choudhary hoped that these programs will make scientists and teachers more globally competitive in the field of research. The Indian Council of Medical Research (ICMR) is the apex body in India for the formulation, coordination and promotion of biomedical research. It is one of the oldest medical research bodies in the world. The Council`s research priorities are undertaken with a view to reduce the total burden of disease and to promote health and well-being of the population. Recognizing the contribution made by the biomedical scientists in various spheres of research, the ICMR has instituted various awards and prizes. ICMR started the tradition of honouring biomedical-scientists in 1953; beginning with "Basanti Devi Amir Chand Award" for senior scientists and "Shakuntala Amir Chand Award" for young scientists, and it is the 60th ICMR Awards function in honour of scientists. The awards recognize the contribution of young scientists as well as those who work in the underdeveloped parts of the country. Also present at the function were Sh Desiraju, Secretary, HFW, Shri Nilanjan Sanyal, Secretary, AYUSH, Dr. V M Katoch, DG, ICMR, Sh Jagdish Prasad, DG, Health services along with the awardees and other senior officers of the Ministry of health and family Welfare. ]]> <![CDATA[ CSIR declares Shanti Swarup Bhatnagar Award 2013]]> https://biospectrumindia.com/news/95/3404/-csir-declares-shanti-swarup-bhatnagar-award-2013.html https://biospectrumindia.com/news/95/3404/-csir-declares-shanti-swarup-bhatnagar-award-2013.html Fri, 27 Sep 2013 14:25:39 +0530 Dr Samir K Bramhachari, director general council for scientific and industrial research (CSIR) has announced the prestigious Shantri Swarup Bhatnagar Awards for the year 2013. The awards were announced during the CSIR's 71st Foundation day Celebrations held here in New Delhi on September 26, 2013. According to it, eight scientists have been selected for Shanti Swarup Bhatnagar Prize for Science and Technology for the year 2013. Under the biological science catagory, Dr Sathees Chukkurumbal Raghavan, department of biochemistry, Indian Institute of Science (IISc),Bangalore has been selecdted for the honour. For medical sciences, Dr Pushkar Sharma of National Institute of Immunology (NII) New Delhi, will recive the award. These awards will be presented by the Prime Minister for which the date will be fixed later on. The Shanti SwarupBhatnagar prize is the most coveted national recognition for young scientists and engineers for their R&D work done in India. The Prize was instituted in 1957 in the honour of late Dr (Sir) Shanti SwarupBhatnagar, an eminent scientist, founder director and principal architect of CSIR. Over 450 scientists and technologists have been so far conferred upon this Prize in various disciplines of science for their outstanding R&D contribution. Each Prize carries a citation, cash prize, a plaque and an honorarium till superannuation. ]]> <![CDATA[CSIR celebrates its 71st foundation day]]> https://biospectrumindia.com/news/95/3368/csir-celebrates-its-71st-foundation-day.html https://biospectrumindia.com/news/95/3368/csir-celebrates-its-71st-foundation-day.html Fri, 27 Sep 2013 13:48:40 +0530 The Council for Scientific and Industrial Research (CSIR) under the ministry of science and technology on September 26, 203 celebrated its 71st foundation day. The concerned minister, S.Jaipal Reddy, who chaired the occasion here in New Delhi complimented the CSIR leadership and Scientists for maintaining CSIR's position in first 100 organizations of the world - to be precise at the 81st position amongst 2740 institutions worldwide. He gave its credit to the able leadership and motivation of Prime Minister Dr Manmohan Singh. On this occasion Shri Reddy also gave away different category of CSIR Awards and said that he see future leaders of Indian science in the CSIR Young Scientist Awardees. He also called call upon them to perform well in times to come and help our country achieve S&T leadership. The Minister emphasized that real value in a knowledge economy, could only be derived from invention and innovation. He said we thus need to invent and innovate more and more and also engage all the stakeholders in doing so. The role of "Responsible Innovation" should be understood in our Country in letter and spirit. It requires building up of an ecosystem of researchers, entrepreneurs and enabling institutions. He said our Country is marching towards that and I see CSIR playing a significant role through its constituent Laboratories - an "Innovation System" in their own right. Reddy said as one of the leaders in innovation in the country, CSIR has greatly energized the National Innovation System through its contributions in the past seven decades. The spectrum of such contributions is quite wide - from import substitution to development of specific industry segments, from strategic capacity creation in some niche segments to marching towards global leadership. He expressed happiness on CSIR's act in increasingly carving out global Science and Technology niches and moving further in enabling the National Innovation System in a strategic manner. He said the setting up of CSIR-Fourth Paradigm Institute (CSIR-4PI) is a testimony to that. The Minister said in the current decade of Innovation, as declared by our Government, CSIR has pursued several innovative activities. Conceptualization of the eHealth Center (eHc) and making it operational by this very institute of CSIR is one among those. He felt a proud to have launched the first eHealth Center in November 2012. Housed in an unused shipping container, it is a unique platform for pursuing the fourth paradigm of science, the data-intensive discovery, while also providing affordable healthcare services to people in need in rural settings, he added. He also expressed happiness on CSIR setting up the Innovation Complexes and its partnership with National Innovation Council (NInC) to strengthen our MSME clusters - he said these steps have now started showing results. Shri Reddy said CSIR is pursuing cutting edge science and is advancing knowledge frontiers. The scientific staff of CSIR only constitute about 3-4% of India's scientific manpower but they contribute to 11% of India's scientific outputs. CSIR is granted 90% of US patents granted to any Indian publicly funded R&D organization and has a wide portfolio of patents in its armory. 13.86% of its patents are licensed, a number which is above the global average. Amongst its peers in publicly funded research organizations in the world, CSIR is a leader in terms of filing and securing patents worldwide. He said CSIR has won the prestigious National Intellectual Property Award 2013, as top R&D institution in Patent. Also, the recognition of CSIR scientists by National Academies is of very high order. In the year 2013, two CSIR scientists received Infosys Foundation Award, out of the seven awarded. The minister pointed that we should not forget that India still lives in villages. People at the base of economic pyramid need our help to enhance their income and remove drudgery. Expressing satisfaction on that CSIR-800 programme he said we need to develop more and more enabling technologies, innovative products and services for people at the base of the economic pyramid. Union Minister for Science & Technology and Earth Sciences and Vice President, CSIR, Shri S. Jaipal Reddy today, on the occasion of CSIR's 71st Foundation Day, gave away different category of CSIR Awards for year 2012 & 2013 here in New Delhi. These awards include The CSIR Young Scientist Award 2013, G.N.Ramchandran Gold Medal for Excellence in Biological Sciences & Technology , CSIR Technology Award 2013 and CSIR Innovation Awards for 2012. The The CSIR Young Scientist Award 2013 was given in the areas of Biological Sciences, Chemical Sciences, Earth, Atmosphere, Ocean and Planetary Sciences, Engineering Sciences and Physical Sciences (including instrumentation). The Biological Sciences Award for 2013 was given to D. Arun Kumar Trivedi of CSIR-Central Drug Research Institute,Lucknow for his outstanding contribution towards identification of novel targets of E3 ubiquitin ligases that regulate tumorigenesis. ]]> <![CDATA[Mental Health Care Bill 2013 to bring paradigm shift]]> https://biospectrumindia.com/news/95/6310/mental-health-care-bill-2013-to-bring-paradigm-shift.html https://biospectrumindia.com/news/95/6310/mental-health-care-bill-2013-to-bring-paradigm-shift.html Thu, 26 Sep 2013 16:58:15 +0530 The Union Minister for Health and Family Welfare, Shri Ghulam Nabi Azad inaugurated the 7th Congress of Asian Society for Child and Adolescent Psychiatry and Allied Professionals, and the 12th Biennial Conference of Indian Association for Child and Adolescent Mental Health. Quoting a study conducted by the Indian Council of Medical Research Shri Azad said that in India the rate of psychiatric disorders in children aged between 4 to 16 years is about 12% and nearly one-third of the population is less than 14 years of age. He noted that similar studies from all over the world have indicated that around 15% of children suffer from significant mental health problems, affecting their functioning. Studies from Asia have shown that 10-20% of children and adolescents have significant health problems. The Central Government has revised and focused on two major components of the National Mental Health Programme in the just concluded 11th five year plan (2007-2012). The Minister stated that the Mental Health Care Bill, 2013, which has been introduced in the parliament to replace the old Mental Health Act, 1987 will bring about a paradigm shift in the area of mental health. The Mental Health Care Bill is currently being examined by parliamentary Standing Committee. The Health Minister said that the National Institute of Mental Health and Neurosciences (NIMHANS), Bangalore which has become an 'Institution of National Importance' will mentor and support Child and Adolescent Mental Health services that will be started at the six new AIIMS and the Centres of Excellence under the National Mental Health Programme. He also highlighted the Rashtriya Bal Swathya Karyakram (RBSK) initiative of Health Ministry, which was launched in February, 2013. The programme aims to provide universal screening and comprehensive healthcare to children between 0 to 18 years of age and will eventually cover 270 million children. The three day conference was attended by 110 foreign delegates from 24 countries and psychiatrists from India. This is the first time the conference is being held in India. Also, present at the function were Dr Yogesh Chawla, Director, PIGMER and senior officers from the Ministry and representatives from the Indian Society of Psychiatry and Indian Society for Social Psychiatry. ]]> <![CDATA[Biogen Idec steps up its CSR activity efforts ]]> https://biospectrumindia.com/news/95/1127/biogen-idec-steps-up-its-csr-activity-efforts-.html https://biospectrumindia.com/news/95/1127/biogen-idec-steps-up-its-csr-activity-efforts-.html Wed, 25 Sep 2013 16:30:00 +0530 Employees of one of the world's oldest biopharmaceutical companies, Biogen Idec, observed 'Care deeply Volunteer Day' across various cities of India as part of its CSR initiative. The employees were given a paid day off to volunteer at a service project in their community. The 'Day of Service' was designed to increase the role of employee volunteerism with focus on patients, science education and local communities. This year, employees served approximately over 300 volunteer hours in more than 12 cities across India. In Gurgaon, employees provided prosthetics to a kid suffering from Cerebral Palsy and organized a green drive at Khusboo Welfare Society, a voluntary Non-Governmental Organization that works for the development, education and rehabilitation of children and young adults with mental and multiple disabilities. In Chandigarh and Bangalore, employees along with their families engaged with children of Bal Niketan and Angel Orphanage. In Kolkata, employees counseled kids at St.Mary's Orphanage and guided them on livelihood and career opportunities. "This innovative program engages our employees in causes that help satisfy their passion and desire to contribute to their communities, while sharing their talents and energy in ways that aligns with our mission of caring deeply and changing lives," said George A. Scangos, Ph.D., CEO, Biogen Idec. "We are proud of the positive impact we have been able to make in the communities in which we operate and are excited that this program continues to expand. This is the most global Care Deeply Volunteer Day so far, with all 28 Biogen Idec affiliate offices participating in the program in countries from Singapore to Norway to India and beyond." Biogen Idec's Care Deeply Volunteer Day was introduced across the company's largest locations in 2011 and rolled out globally to Biogen Idec offices in 2012. More than 1,600 employees embarked on Care Deeply Volunteer Day initiatives in 2012, participating in more than 80 projects in 22 countries around the world. "BIIB India has always been committed to the credo of Care Deeply, through multiple initiatives like raising funds for Uttarakhand Flood victims, contributing to NGO's such as Goonj, Khushboo Welfare Society, supporting the old age home for women & encouraging employees to volunteer actively as part for CSR. Care deeply day is an opportunity for us to make a difference through our contribution as a team by devoting a day of service to support the society in the best possible manner" said Sameer Savkur , Managing Director Biogen Idec, India. ]]> <![CDATA[Innovators meet policy makers, talk big on industry expansion ]]> https://biospectrumindia.com/news/95/3446/innovators-meet-policy-makers-talk-big-on-industry-expansion-.html https://biospectrumindia.com/news/95/3446/innovators-meet-policy-makers-talk-big-on-industry-expansion-.html Wed, 25 Sep 2013 11:52:00 +0530 The second edition of the Biotechnology Industry Research Assistance Council (BIRAC) Innovators Meet 2013, was held at Manesar (Haryana) on September 23-24, 2013. Much visible from the theme 'Catalysing the Growth of an Innovation Driven Biotech Enterprise', the meet this time was focused on policy changes and pathways to drive the Indian Bio-economy to reach $ 100 billion by 2025. The distinguishing factor about the event was the keen focus given on innovators to interact, network and discuss successful case studies, challenges and opportunities for strengthening the biotech enterprise. The meet was inaugurated by Prof. K VijayRaghavan, secretary, department of biotechnology (DBT) and chairman, BIRAC. In his address to the gathering, he talked about empowering the young innovators in various areas is one of the strategic keys to achieve the expansion of industry. "We need to work towards building a strong system of innovation," he said. Dr Renu Swarup, managing director, BIRAC while welcoming the delegates expressed hope that the forum will help them in identifying the opportunities to collaborate and work together for laying down a road map to future. She said further, "One of the key strategies of BIRAC is fostering innovating capabilities in all places of research and with a focus on start-ups and SMEs" In his opening remarks, Dr G Padmanabhan, NASI-chairman and former director, Indian Institute of Science, talked about the potential that stem cells and computational biology offer. He wondered whether India could ever replicate the big manufacturing units US has in the area. He mentioned further, "Fifteen manufacturing institutions set up in US. I imagine can we have such implementation in India." Dr Padmanabhan expressed happiness on the spectrum of schemes by BIRAC and exhorted industry to take full advantage. He had a word of caution as well. He advised the BIRAC that its focus areas should be limited. "Rather than going into too much of diversification, the selection of the best be maintained. "Diverse projects don't instill confidence. You may face difficulties with utilization. Make best use of money," he advised. Speaking on regulatory landscape, he said,"There is a great difficulty in regulations. We go from one extent to other between DCGI and other agencies. Activism is sometimes good too as it keep a tab on any wrongdoing but it has to be right spirit. For the unnecessary criticism, there has to be proper education." The flagship BIRAC Innovators Award was awarded to five best innovations by the industry. SMEs and academia were encouraged to participate in the business idea Pitching Session and Poster Presentation. industry delegates got the opportunity to interact with Prof. K. VijayRaghavan, secretary, DBT and Dr M. K. Bhan, former secretary, DBT and discuss the policy challenges in the Indian Biotech sector. The meet concluded with the recommendations for fostering the innovation in Indian Bio-economy and creating environment conducive for the commercialization of socially relevant and responsive innovations. More than 200 stakeholders including policy makers, Industry leaders, start-ups, entrepreneurs and academic researchers attended the meet. The two day long meet witnessed the deliberations on issues ranging from funding opportunities for Bio-entrepreneurs, fostering innovation through bio-enterprises and issues and concerns in biopharma, bioagri, bioindustrial, bioservices and bioinformatics. The amalgamation of thoughts from industry and academia highlighted the issues critical for the growth of biotechnology in India and the measures to address them. ]]> <![CDATA[Suven secures three new NCE patents in NZ, Singapore and South Korea]]> https://biospectrumindia.com/news/95/3441/suven-secures-three-new-nce-patents-in-nz-singapore-and-south-korea.html https://biospectrumindia.com/news/95/3441/suven-secures-three-new-nce-patents-in-nz-singapore-and-south-korea.html Wed, 25 Sep 2013 11:40:00 +0530 The patents are valid through 2029, 2030 and 2028 respectively, said the company's press release. "We are very pleased by the grant of these patents to Suven for our pipeline of molecules in the CNS arena, that are being developed for cognitive disorders with high unmet medical needs, having a huge market potential globally," said Mr Venkat Jasti, CEO, Suven. The granted claims of the patents include the class of selective 5-HT compounds discovered by Suven and are being developed as therapeutic agents, useful in the treatment of cognitive impairment associated with neurodegenerative disorders like Alzheimer's disease, Attention Deficient Hyperactivity Disorder (ADHD), Huntington's disease, Parkinson's and Schizophrenia. With these new patents, Suven now totally has seventeen granted patents from New Zealand, sixteen from Singapore and eleven from South Korea. Products out of these inventions is expected to be out-licensed at various phases of clinical development, that is, at Phase-I or Phase-II. ]]> <![CDATA[Lilly MDR-TB Partnership, CNS come up with report on best practices ]]> https://biospectrumindia.com/news/95/7236/lilly-mdr-tb-partnership-cns-come-up-with-report-on-best-practices-.html https://biospectrumindia.com/news/95/7236/lilly-mdr-tb-partnership-cns-come-up-with-report-on-best-practices-.html Tue, 24 Sep 2013 17:34:19 +0530 Citizen News Service (CNS), with support from the Lilly MDR-TB Partnership, recently released a report examining how drug-resistant tuberculosis in India is managed. The report covers lessons learned from selected sites in six cities across the country, and makes recommendations for improvements. CNS embarked on a mission to document the best conventions and lessons learnt from select sites of Programmatic Management of Drug-resistant Tuberculosis (PMDT). The survey included nearly 200 key informant interviews, cured patients of multi-drug-resistant TB (MDR-TB), MDR-TB patients currently on treatment and their family members, extensively drug-resistant TB (XDR-TB) patients, nurses, doctors, laboratory technicians, microbiologists, PMDT site nodal officers, state and district TB officers to analyze and conclude the major factors in practice that could bring about a Universal access to quality diagnostics and treatment programs for PMDT across India. This report was generated to address MDR-TB's disease burden in India. The report is based on a survey and detailed research undertaken to find the major practices involved in educating, treating, managing and improving the overall situation of PMDT in various regions of India. The various practices and methodologies, practiced by several medical institutions were observed, highlighted and questioned by CNS during January-June 2013. ]]> <![CDATA[BIRAC's 3i Portal honored with SKOCH Order-of-Merit]]> https://biospectrumindia.com/news/95/3436/biracs-3i-portal-honored-with-skoch-order-of-merit.html https://biospectrumindia.com/news/95/3436/biracs-3i-portal-honored-with-skoch-order-of-merit.html Tue, 24 Sep 2013 17:31:00 +0530 The Biotechnology Industry Research Assistance Council's (BIRAC) 3i Portal was honored with SKOCH Order-of-Merit for India's best in smart governance and digital inclusion. BIRAC's managing director, Dr Renu Swarup received the award from Mr J. Satyanarayana, secretary, department of electronics and information technology (DeitY), ministry of communication and information technology, government of India and Mr Sameer Kochhar, chairman, SKOCH Group. The 3i - "Investment for Industry Innovation Research" - Portal has been developed for sustainable, accountable, transparent governance and management of the investment schemes of national importance run and managed by BIRAC. ]]> <![CDATA[Johnson & Johnson to resume manufacturing of cosmetics at the Mulund plant ]]> https://biospectrumindia.com/news/95/7068/johnson-johnson-to-resume-manufacturing-of-cosmetics-at-the-mulund-plant-.html https://biospectrumindia.com/news/95/7068/johnson-johnson-to-resume-manufacturing-of-cosmetics-at-the-mulund-plant-.html Tue, 24 Sep 2013 16:55:11 +0530 The Bombay High Court today allowed baby products manufacturer Johnson & Johnson to restart the manufacturing of baby powder at its Mulund unit, which had been stopped upon the order of Maharashtra Food and Drug Administration. The Honourable High Court passed this judgment after due consideration of all facts related to the case. The court also found the company's offer to test the batches of baby powder in question, reasonable. Further, there was no scientific foundation that there were any carcinogens present in that batch of baby powder. "Nothing is more important to us than the well-being of consumers, and we see this outcome as a significant step in restoring their confidence. We will continue to work closely with Maharashtra FDA, and provide India with safe, high quality products that help people care for themselves and their families," said a Johnson & Johnson, India spokesperson. For the past 100 years, Johnson & Johnson has earned the trust of over one billion families and healthcare professionals. Johnson's® Baby aspires to touch every baby in India with brands operating in the widest consumer spectrum. ]]> <![CDATA[Medtech conference to analyse medical device in India ]]> https://biospectrumindia.com/news/95/7580/medtech-conference-to-analyse-medical-device-in-india-.html https://biospectrumindia.com/news/95/7580/medtech-conference-to-analyse-medical-device-in-india-.html Tue, 24 Sep 2013 16:46:00 +0530 The Health Ministry has recently sought the cabinets nod for a new Drugs and Cometics Bill, 2013 to replace the existing Act of 2007, to help bring the growing medical equipment industry in the country under the specific regulation of a law. Recongnizing this initiative by the government, and to discuss the upheaval in medical device regulations and the enforcement of more stringent guidelines that may come in with this initiative, Medtech India will also host conferences on 'Government support to boost the industry', 'Regulatory regime: Current status', 'Trend Analysis: Medical devices as industry in India' and more. Mr Sanjay Banerjee, (MD, Zimmer India) says 'While the medical devices industry has made important contributions towards improving health outcomes for Indian patients and towards growth of the overall healthcare industry, it has the potential for an even greater role going forward along with its own exponential growth. The ability to realize this potentially will, of course, be dependent on the regulatory system and facilitative policies and ecosystems for innovation, manufacturing and overall grwoth of the sector. Towards this objective, Medtech India is an important platform bringing together all stakeholders for constructive discussions on the roadmap for the future." Recongnising the growing industry and the need to regulate and help bring the booming medical equipment industry in the country on one platform, Medtech India 2013, taking place on 3rd and 4th October, 2013 at The Lalit, will offer the platform to showcase innovative solutions and an opportunity for dialogue between stakeholders not only from the meteros but also facilitate demands from the tier-1 and tier-2 cities. Indian and interbational comapnies like BioInteractionsLtd, Ametek Insruments india Pvt Ltd, Millenia Technologies, Martech Medical, Zeus, SMC Global and more will be part of this event that will have range of unique networking and social engagement opportunities. ]]> <![CDATA[Taklamakan Gold a new generation of effect pigments in India]]> https://biospectrumindia.com/news/95/6293/taklamakan-gold-a-new-generation-of-effect-pigments-in-india.html https://biospectrumindia.com/news/95/6293/taklamakan-gold-a-new-generation-of-effect-pigments-in-india.html Mon, 23 Sep 2013 16:43:00 +0530 Meoxal Taklamakan Gold follows Meoxal Wahiba Orange as the second effect pigment in the new Meoxal range to be launched in India. Speaking about the new launch, Siddhartha Sengupta, regional sales director Asia (Decoratives) said, "With the tremendous response received for the Meoxal Wahiba orange, we continue to support our customers in the development of new and innovative coatings. With the launch of Meoxal Taklamakan in India, we are setting yet another milestone in pigment technology and are confident that it will be well received by the auto and plastic coating industry." As a pioneer in the effect pigments, Merck has always been at forefront of advanced technology and the latest in global trends. Taking its commitment forward, Merck created Meoxal giving cutomers an opportunity to witness and experience the latest innovation in the world of design. Like all pigments in the new product series, Meoxal taklamakan gold has a specially treated surface. Thanks to the special Carbitol and Weather treatment (CWT) surface treatment; it is highly suitable for innumerable high performance applications. Using the new pigment in waterborne coating systems is particularly straightforward because no additional passivation is needed. ]]> <![CDATA["We have made a valuable discovery in lowering enzyme production costs through culture and process optimization"]]> https://biospectrumindia.com/interviews/95/4643/we-have-made-a-valuable-discovery-in-lowering-enzyme-production-costs-through-culture-and-process-optimization.html https://biospectrumindia.com/interviews/95/4643/we-have-made-a-valuable-discovery-in-lowering-enzyme-production-costs-through-culture-and-process-optimization.html Fri, 20 Sep 2013 16:49:00 +0530 Tex Biosciences was the first Indian company to indigenously manufacture and supply enzymes to the leather market. Its products were import substitutes at a time when all leather enzymes were being imported, and tanners faced problems in foreign exchange availability for imports. Tex Biosciences is one among few organizations to manufacture all its enzymes in house and formulate high performance enzyme mixes for better productivity in animal farming. BioSpectrum interviewed Mr Aravindha Krishnamachari, director and chief operations executive, Tex Biosciences (P) Ltd, to get insights into the company's current and future plans. Mr Krishnamachari also heads the production department at Tex Biosciences with emphasis on supply chain integration and lean manufacturing practices. What is the contribution of Tex Biosciences in the area of Industrial Biotechnology and leather chemical products?Tex Biosciences has performed strongly in the area of Industrial biotechnology with operations in leather, animal feed, textiles and pulp and paper Industry. With the leather industry, Tex Biosciences was the first Indian company to indigenously manufacture and supply enzymes to the leather market. Our products were import substitutes at a time when all leather enzymes were being imported, and tanners faced problems in foreign exchange availability for imports. We are one of the few organizations to manufacture all our enzymes in house and formulate high performance enzyme mixes for better productivity in animal farming. What is the current market trend in India for leather chemical products?The Indian leather Industry is facing challenges that need to be overcome. There is raw material shortage that is affecting tanners productivity. New environmental regulations require a change in mindset and processing requirements from customers. We are seeing customers genuinely being interested in adopting greener technology and stricter European norms in leather processing. We take our market leader position in leather enzymes responsibly and seriously. We have a very experienced and an able technical team, that is assisting our customers in enzyme usage that extends outside the traditional roles in leather processing. Some of our enzyme inventions are unique to the market such as complete elimination of sulphides and lime in unhairing process, converting dead stock of finished leather into new material and increasing the penetration of chemicals into leather. What are your latest innovations and what are their practical applications?Our innovations extend to all the markets we operate. With animal feed, we have launched a protease based enzyme mix that helps farmers and feed mills reduce protein cost in feed. With rising soya prices, farmers are looking for innovations that help them manage feed costs while delivering good productivity. Our product has been able to successfully deliver on its promise. In leather, we have launched a very successful stable liquid enzyme formulation that allows dried skins and hides to be wetted for processing with a 75 per cent reduction in water usage and 200 per cent reduction in time. In pulp and paper Industry, we have introduced an enzyme mix that helps recycle juice cartons by separating aluminum foil from cardboard. What are the eco-friendly alternatives that you inculcate in products?Our company mantra is "Nurturing Nature" and all our products reflect this, be it enzymes or the chemicals we manufacture. A few such examples of our commitment to nature include our enzyme formulations in leather which eliminates solvent usage in leather degreasing process and an enzyme mix that helps in better dye penetration in textile industry. Can you tell us about your collaborations both in India and abroad?Tex Biosciences has export presence in 22 countries across the globe. We are now working on partnership with a South American company for commercialization of enzyme usage in Biofuels. We have also tied up with a company in Africa and are exploring setting up a manufacturing base there. What sets apart Tex Biosciences in the area of innovation from the rest of the companies in the same arena?They say necessity is the mother of all inventions. This is exactly what motivates and drives us. We employ experts in all the markets we operate and these experts are engaged in exploring newer applications for enzyme usage along with solving existing problems with biotech products. We also take our leadership position in the market very seriously and constantly look at areas where we can innovate and offer value to customers rather than focus merely on sales and profit generation from our leadership position. Would you like to share any recent interesting discoveries made by Tex Biosciences?We have made a valuable discovery in lowering enzyme production costs through culture and process optimization, the details of which are confidential. Through this discovery, we have been able to significantly lower our production costs and offer value to customers. What are your visions, plans and goals for Tex Biosciences?Tex Biosciences is a family owned and run organization. Founded in 1976 by my father Mr R P Krishnamachari, the company has seen growth and enhancement of its reputation in all the markets it operates. The company aims to further expand its reach into newer markets and function as India's leading industrial enzyme manufacturer with home grown technology by 2020. This vision and determination is shared by our valuable employees who see themselves as a part of our family. Who are your competitors?Industrial enzyme manufacturers domestically and internationally are our competitors. More than competition, we focus on the customers who we serve and constantly seek improvement in product offering to bring better value to them. How is the company doing financially?Tex Biosciences has been doing very well financially and we have been financially inspected and certified by ICRA. We have doubled our turnover in the last 4 years along with good numbers and ratios in all critical parameters. What are the significant investments made by Tex Biosciences?We believe that a world class manufacturing facility alone can deliver high quality products. As an ISO 9001-2008 certified organization, we are committed to maintaining a high quality production facility. We have invested over 14 Crore (INR) in the last two years to triple our fermentation capacity along with necessary Utility and Down Stream processing equipments. We now have dedicated large scale semi automated fermenters which are enzyme specific. Further, our production plant holds exclusive finished goods manufacturing and packing lines for all the markets we operate. In the midst of economic recession, how is the growth sector looking for Tex Biosciences?We have gone for large scale expansion in the midst of an economic recession. This is primarily due to the confidence we have in our ability and our conviction that we offer value to customers. We believe that once the markets pick up, we would be best suited to serve the increased demands through the capacity we have built up during the lean period. We also seek to enter the contract manufacturing segment by offering clients our experience and facility in manufacturing biotech products that are required by them. We believe that our experience in operations and the cost factor that we bring to the table would make us more lucrative as a CMO. How is Tex Biosciences involved in CSR activities?We are an ISO 9001-2008 certified organization that is involved heavily in social responsibility by contributing to the society. The founder, Mr R P Krishnamachari, and the company - both are involved in running schools, education and health projects throughout Tamil Nadu. What can we look for from Tex Biosciences in the future?Tex Biosciences seeks to make a name for itself in the Biotech Industry in India. We have a spring in our step and confident that we would achieve our vision and mission by 2020. ]]> <![CDATA[Clariant Chemicals relocates its Masterbatches plant]]> https://biospectrumindia.com/news/95/3229/clariant-chemicals-relocates-its-masterbatches-plant.html https://biospectrumindia.com/news/95/3229/clariant-chemicals-relocates-its-masterbatches-plant.html Fri, 20 Sep 2013 12:51:00 +0530 Commenting on the relocation of the Masterbatches plant to Maharashtra, Dr Deepak Parikh, vice-chairman & managing director, Clariant Chemicals (India) Limited said, "This move will help Clariant in India further improve its market presence and strengthen its position in India. The new plant will be operationally effective from December 2013." Mr Sandeep Puri, head of Masterbatches business in India added, "The rationale behind this move is to primarily expand production capacities and build a fully refurbished and modern production unit under one roof. "The new facility will be instrumental in Clariant's efforts to introduce latest technologies and systems to its customers at an even quicker pace than before, and generate value with cutting-edge innovations and highly customized local solutions through global best practices." ]]> <![CDATA[India gets three new biotech products in August ]]> https://biospectrumindia.com/features/95/4623/india-gets-three-new-biotech-products-in-august-.html https://biospectrumindia.com/features/95/4623/india-gets-three-new-biotech-products-in-august-.html Fri, 20 Sep 2013 10:54:04 +0530 Amidst the negative news surrounding the entire country, there were some positive developments announced this August by the bioscience industry that need to be celebrated, and India can take pride in what has been achieved. First, in the area of vaccines, the country's largest vaccine producer and number one biotech player, Serum Institute of India announced a path breaking research output in collaboration with the University of Pune. It received an US patent for the use of Ashwagandha as a vaccine adjuvant. This is probably the first instance of a patent being granted for use of an ayurvedic herb as vaccine adjuvant. Ashwagandha, which is known as Indian Ginseng, is used popularly as an immunity enhancer here. The Department of Science and Technology (DST) had sponsored this joint research project of Serum and Inter-disciplinary School of Health Sciences (ISHS), University of Pune. Congrats to the Serum's team consisting of Dr Suresh Jadhav, Dr Sunil Gairola, and Dr Yojana Shinde and ISHS scientists lead by Dr Bhushan Patwardhan, Dr Dada Patil, and Dr Sanjay Mishra. This Ashwagandha adjuvant was found to be much more effective than the traditional adjuvant in applications related to diphtheria, meningitis, and tetanus, and the US patent will hasten the process of applying this outcome to newer vaccines. It also holds good promise for applying it to HIV, malaria, and TB. Another indigenous vaccine company Bharat Biotech announced the launch of Typhoid Vi Capsular Polysaccharide-Tetanus Toxoid conjugate vaccine, branded Typbar-TCV. The advantage of this conjugate vaccine is that it is effective in both infants who are over six months and adults. The second major announcements were in the area of cancer treatment. Two Indiamade drugs have crossed major milestones. The second largest biotech company, Biocon, launched a novel biological drug Alzumab (Itolizumab) at almost half the cost of the available products in India. This is the first anti-CD6 monoclonal antibody to be developed and commercialized in India. In another development, a new drug to treat prostate cancer jointly developed by India's leading CRO Jubilant Biosys and US-based Endo Pharmaceuticals got the approval from USFDA for further development. FDA has accepted their Investigational New Drug (IND) filing application, which is the first regulatory stage of acceptance of the potential of the new molecule and the clinical trials of the product will start later this year. These announcements should not be construed that the industry found a path out of the crisis. These outcomes are not as a result of streak of innovation during a period of economic crisis. It is a sheer coincidence. But these developments will have a long-term impact and could possibly become game changers. The slide of rupee against the dollar and the weak economic situation in the country are worrying the industry, though it has not been directly impacted by the financial melt down in the country. However, there are many other issues concerning the industry that, if notaddressed can take the industry to newer levels of distress. In June BioSpectrum said industry is at an inflection point. There was slowdown in the growth of the industry in general, but the heartburn in particular was that bioagri and clinical trials business had come to a grinding halt. The BRAI Bill is still to be passed. The Parliament voted for food security and passed the Bill. The government is calling it the game changer. The Bill guarantees a lot of things. The important question is how will this be possible if food production, agriculture, and nutrition are not a priority? ]]> <![CDATA[Strides Arcolab receives USFDA approval for its Italian facility]]> https://biospectrumindia.com/news/95/3179/strides-arcolab-receives-usfda-approval-for-its-italian-facility.html https://biospectrumindia.com/news/95/3179/strides-arcolab-receives-usfda-approval-for-its-italian-facility.html Thu, 19 Sep 2013 17:32:00 +0530 This state-of-the-art, EU and TGA (Therapeutic Goods Administration, Australia) approved facility located in Milan, Italy, manufactures liquids, semi-solids, ointments and creams. The company is expecting its first approval of a niche semi-solid product by first quarter in 2014. Commenting on the event, Manish Gupta, CEO - Pharma said, "This approval provides further impetus to our pharma business and marks our foray into the attractive but complex semi-solid market in US. Our first product, which is expected to be commercialized by first quarter in 2014, has undergone extensive clinical trials. The product will be marketed by one of the top 10 generic companies in the US market". Strides is currently developing a portfolio of liquids and semi-solids products for the US and EU markets, and currently has over 12 products at various stages of development and approvals. Strides already sells semi-solids in the UK market. ]]> <![CDATA[WHO clears Panacea Biotec's pentavalent vaccine, Easyfive TT ]]> https://biospectrumindia.com/news/95/5019/who-clears-panacea-biotecs-pentavalent-vaccine-easyfive-tt-.html https://biospectrumindia.com/news/95/5019/who-clears-panacea-biotecs-pentavalent-vaccine-easyfive-tt-.html Thu, 19 Sep 2013 16:21:00 +0530 The World Health Organization (WHO) has recently completed the evaluation process of pre-qualification (PQ) of Delhi based Panacea Biotec's pentavalent vaccine EasyfiveTT (DTP-HepB-Hib) sucessfully and has, vide its communication dated September 17, 2013, conveyed that they are initiating the arrangements for PQ. This was announced by the company at a select press briefing held in New Delhi on September 19, 2013. WHO has also informed the UNICEF (procurement agency for global markets) of the positive outcome of the evaluation process and will be issuing the letter to UNICEF informing the PQ of EasyfiveTT mono (1 dose) and multi-dose (10 dose) presentations and the details of PQ will be published on WHO webpage soon. The company has successfully completed the audit of its Lalru and Baddi facilities, conducted by WHO team from February, 28 till March 01, 2013. Company is now preparing itself to supply EasyfiveTT vaccine (pentavalent vaccine that protects against five diseases-Dipheria, Tetanus, Pertussis, Hepatitis B and Haemophilus influnzae type b (Hib) of early childhood.) to UNICEF and other international agencies involved in procurement of vaccines at global as well as national levels in various countries. Speaking to media, Dr Rajesh Jain, joint management director explained, "It was a great experience to have worked with every individual involved in vaccines operations at both Lalru and Baddi sites in rebuilding our new Quality Management System (QMS). The whole effort was focused right from getting the organisation ready for change to designing systems to prevent problems. We had focused on getting our thinking process right and move from paper to robust QA system ensuring patient safety as our key goal." Adding further, Dr Jain said, "Today, the company internally has subject matter experts and the champions on every aspect of QMS. The system brought in sufficient attention to science and decision making process while taking quality decisions keeping patient safety in mind. In the end it was a collective and collaborative effort for change and has to continue with even greater enthusiasm to the next level in the coming years. I would like to take this opportunity to thank all our customers, partners, suppliers, bankers, investors and employees for thier faith and continued support during this challenging period." Panacea Biotec developed and introduced the world's first fully liquid pentavalent vaccine in the year 2005 and achieved WHO pre-qualification in July 2008. Since then untill June 2011, the company had supplied over 45 million doses for usage in around 31 GAVI/non GAVI countries worldwide. Fully Liquid Pentavalent Vaccine continues to be a high priority vaccine for WHO, UNICEF and GAVI. UNICEF continues to increase procurement of pentavalent year on year and has purchased pentavalent vaccine 168.5 million doses worth US$ 418 million spending 40.5% of funds spent on all vaccines purchased in 2011 as compared to 97.5 million doses worth US$ 292 million purchased in the year 2010. As per the GAVI forecasts, the overall demand for pentavalent vaccine is expected to increase to over 234 million doses by 2016 and thereafter to 256 million doses by 2019 for all the 73 GAVI eligible countries. ]]> <![CDATA[FDA finds hair, oil spots on tablets at Ranbaxy's unit]]> https://biospectrumindia.com/news/95/6286/fda-finds-hair-oil-spots-on-tablets-at-ranbaxys-unit.html https://biospectrumindia.com/news/95/6286/fda-finds-hair-oil-spots-on-tablets-at-ranbaxys-unit.html Thu, 19 Sep 2013 15:52:00 +0530 Post this incident, the USFDA became highly alert and imposed an import alert on its Mohali plant, stating that the drugmakers manufacturing units were not up to the industrial standards. This import alert has prohibited Ranbaxy from manufacturing FDA-regulated drugs at its Mohali facility unit. Ranbaxy said that it would review FDA's details on import alert and take necessary corrective actions to rectify the situation. In its statement, Ranbaxy said, "The USFDA had conducted inspections at Ranbaxy's Mohali facility last year (2012), resulting in certain observations. The company believes that it has made further improvements at its Mohali facility. We'll remain committed to addressing all concerns of the USFDA." Other findings of the FDA included the use of dirty glassware, packaging line failure, dark spots on tablets from the oils from machines, abrasions on tablet surfaces and absence of running water in toilets. ]]> <![CDATA[Kemwell signs agreement with European Company]]> https://biospectrumindia.com/news/95/3161/kemwell-signs-agreement-with-european-company.html https://biospectrumindia.com/news/95/3161/kemwell-signs-agreement-with-european-company.html Thu, 19 Sep 2013 15:16:26 +0530 Kemwell will provide a fully integrated solution including technology transfer, process industrialization, scale-up, manufacturing of toxicology materials, cGMP manufacturing of clinical materials and commercial manufacturing for both drug substance and fill & finish in vials from Kemwell's new state-of-the-art biopharmaceuticals facility in Bangalore. "This broad development and manufacturing agreement demonstrates our customers' confidence in Kemwell's biotechnical capabilities. Partnering with a number of well-known technology providers, Kemwell aims to establish itself as a leading player in the one-stop-shop biopharmaceutical contract manufacturing space. "Our over 30-year expertise in the pharmaceutical development and manufacturing space will help us provide high quality services and products at competitive prices to the biotech industry. We are also expecting an inspection from a European agency for our biopharmaceutical drug substance as well as fill-finish facility, during the second half of this year," said Mr Anurag Bagaria, managing director, Kemwell Biopharma. In 2008, Kemwell entered into a strategic collaboration with Boehringer Ingelheim, Germany. These facilities have been designed with the engineering and operational support of Boehringer Ingelheim. Kemwell Biopharma is an Indian global contract development and manufacturing company. The company develops and manufactures bio-pharmaceuticals for pharmaceutical organizations. ]]> <![CDATA[UBM India Launches Pharma Awards ]]> https://biospectrumindia.com/news/95/3434/ubm-india-launches-pharma-awards-.html https://biospectrumindia.com/news/95/3434/ubm-india-launches-pharma-awards-.html Thu, 19 Sep 2013 12:07:38 +0530 As the pharma industry is increasingly looking towards India for higher quality and low cost pharma solutions. The UBM India Pharma Awards will serve as a platform for companies to engage with the movers and shakers in India's pharma machinery, technology, ingredients, outsourcing biopharma industry. In addition to increased visibility and media attention in the pharmaceutical industry leaders and media alike. The launch saw the likes of veterans in pharma industry sharing the stage and being the jury members. The dignitaries were Mr. Ajit Singh, Chairman ACG Worldwide, Mr. Murlidharan Nair, Partner consulting practice of Ernst and Young (EY) India and Mr. Joji George, MD, United Buisness Media (UBM) and the jur comprised of Dr. Ajit Dangi, President and CEO Danssen Consulting, Mr. Devinder Pal, President, Catalyst Pharma Consult, Mr. Kaushik Desai, member of the Scientific committee of Indian Pharmaceutical Association (IPCA) (2010-2013) and Mr. Subodh Priolkar, GM, Colorcon Asia Ltd. Speaking at the launch Mr. Singh expressed "The awards initiated by UBM India is the first pharma awards in the country. Its never too late to recognize great people." The theme of the launch of India Pharma Awards is in line with the rapid growth of the Indian pharmaceutical Industry. It is 'Excellence'. The awards are categorized as Operational excellence, Excellence in product development, Excellence in contract research, life time achievement award, emerging entrepreneur of the year and so on. At the same time Dr. Dangi commented on moving up the Global Pharma Value Chain "Our pharmaceutical industry has shown phenomenal growth. However our contribution to world's pharmaceutical industry is less than 2%, so in that context value chain is important. Moving up Global value chain means moving up discovery and innovation. India alongside generics should also focus on global value chain." He also emphasized on the need of cultural change so as to be on global chain stage. Mr. Pal also opined his views on the same "Government policies has helped develop pharma industry. Value chain doesn't mean continuing manufacturing for pharmaceutical industry." ]]> <![CDATA[Recognize the positive contribution in the pharma industry: Mr. Joji George]]> https://biospectrumindia.com/interviews/95/3427/recognize-the-positive-contribution-in-the-pharma-industry-mr-joji-george.html https://biospectrumindia.com/interviews/95/3427/recognize-the-positive-contribution-in-the-pharma-industry-mr-joji-george.html Thu, 19 Sep 2013 11:55:00 +0530 In a small interaction Mr. Joji George, Managing Director, UBM India, revealed the idea and concept behind the initiation of UBM India Pharma Awards 2013. Mr. George commented "These awards are entirely dedicated to pharma industry. The awards are going to be globally the biggest pharma awards. Further he added "Given our thoughts and interactions we thought time is opportune to take a stand, celebrate the excellence and recognize the positive contribution in the pharma industry." Talking about the process and jury of the awards he opined "The kind of jury members endorsing the awards itself sets up a standard and stage for the awards. In terms of process and validation its going to be transparent and screened by highly talented team of Ernst and Young (EY)." Commenting on UBM's role he said "We bring people together in business to business space. We address community together. With the success of these awards will try and tap other markets as well. Apart from this we will push ourselves with these awards to different locations like Sri Lanka and all to get wider acceptance." ]]> <![CDATA['Turning technology and innovations in to money and jobs']]> https://biospectrumindia.com/news/95/4829/turning-technology-and-innovations-in-to-money-and-jobs.html https://biospectrumindia.com/news/95/4829/turning-technology-and-innovations-in-to-money-and-jobs.html Wed, 18 Sep 2013 15:26:00 +0530 Titled 'RiffStream# Bangalore-II Digital Innovations in Healthcare: Doing More with Less', the workshop was held at the Centre for Cellular and Molecular Platforms (C-CAMP) auditorium here in Bangalore. The workshop aimed at creating opportunities for exchange of research, insights and innovation in the healthtech sector. Speakers at the event included Sir Leszek Borysiewicz, vice chancellor, University of Cambridge, who delivered the key note, Dr Santanu Chattopadhyay, founder & managing director, Nationwide Doctors, Dr Mohanasankar Sivaprakasam, Head, Healthcare Technology Innovation Centre (HTIC), Dr Taslim Saiyed, director & COO, C-CAMP India and others. The workshop focused on using the RiffStream# methodology to explore new ways of facilitating collaboration across sectors, technologies and investors, with the aim of generating new projects and partnerships as the basis for delivering innovation and securing funding. It also concentrated on innovations in healthcare facilitated by mobile, digital, telecoms and computing technologies, leading to new technological devices and processes to do more with less to increase the efficiency. RiffStream# is based on a simple musical analogy: Chords (ideas, concepts, technologies and market needs) combined into Riffs, where chords are integrated in to a product or a service which meets an existing or new market need. The event had a five themed set-up: Innovation in Delivery Systems, Technology Enabled Innovation, Regulation, Point Solutions, and Tele-Health. The workshop was organized by AcceleratorIndia and supported by the Electronics, Sensors & Photonics Knowledge Transfer Network (ESPKTN), in partnership with UK-SIN, C-CAMP and National Centre for Biological Sciences (NCBS) under the support of Bangalore Cambridge Innovation Network. ]]> <![CDATA[Tremendous innovation and ideation taking place in the bio industry: Dr Kiran Mazumdar]]> https://biospectrumindia.com/news/95/3431/tremendous-innovation-and-ideation-taking-place-in-the-bio-industry-dr-kiran-mazumdar.html https://biospectrumindia.com/news/95/3431/tremendous-innovation-and-ideation-taking-place-in-the-bio-industry-dr-kiran-mazumdar.html Wed, 18 Sep 2013 12:27:00 +0530 Eminent personalities from the bioscience and life science industry including Dr Kiran Mazumdar-Shaw (Biocon), Dr Taslim Saiyed (C-CAMP), Mr Jon Mowles (UKTI-LSIO), Dr Balaji Ganeshan (TexRAD) and others graced the discussion with their presence. Mr Narayanan Suresh, chief editor, BioSpectrum, served as the chairperson for the discussion. Commenting on the significance of innovation and collaboration with UK companies in the bioscience arena, Dr Kiran Mazumdar-shaw, chairman & managing director, Biocon, said, "There is tremendous innovation and ideation taking place in this industry hub. It is time for companies in the UK to start encouraging research groups in this part of the world. There should be a lot more intervention from both sides. The whole objective should be about face-to-face meetings and visits because seeing is believing. That's what will make it click." Initially, there were two separate panel groups who parallely carried out discussions. One group discussed the importance of innovation and collaboration in the bioscience industry and the other on imperativeness of technology in the same context. The final round chaired by Mr Suresh, along with a few other delegates saw the culmination of the roundtable discussion with a short Q&A session at the end. Mr Kam Dhaliwal, vice president of global sales, Horizon Discovery Limited, UK, another delegate at the session spoke about UK's underfunded biotechnology industry. He added, "My professional experience is centered around US and Japan. A lot of UK biotech companies are underfunded. Hence you do drug discovery on your own. That's a problem we have in the UK. UK is suffering tremendously from underfunding. This is where the UK government and set-up should help kick-start and continue to develop the expansion of UK biotech industry." ]]> <![CDATA[Abbott's high sensitive troponin test to women's rescue]]> https://biospectrumindia.com/news/95/3418/abbotts-high-sensitive-troponin-test-to-womens-rescue.html https://biospectrumindia.com/news/95/3418/abbotts-high-sensitive-troponin-test-to-womens-rescue.html Wed, 18 Sep 2013 10:39:00 +0530 Recently Abbott announces promising preliminary results from a study presented at the ESC Congress 2013. It suggests that high sensitive troponin test may help doctors improve the diagonosis and prognosis of patients presenting with symptoms of a heart attack. The test could be particularly beneficial for women, who may have different presenting symptoms and are often under-diagnosed. The study, which is being conducted by researchers at the university of Edinburgh, is evaluating Abbott's ARCHITECT STAT High Sensitive Troponin-I (HsTnI) test, which received CE Mark in January 2013. Cardiac troponin, a protein found in the heart muscle, is considered the preferred bimaker to identify suspected heart attacks, because it can detect injury to the heart. Abbott's hsTnI test can measure very low levels of this protein, which is especially important for women, who often have lower levels of troponin than men. "While Abbott's high sensitive troponin test benefits both men and women with earlier detection of heart attacks, the potential to increase the diagnosis among women is especially important," said John Frels, PHD, divisional vice president, Diagnostic Research, Abbott. "This is the first time we have seen a test that can provide this kind of detailed information to doctors and has the potential to aid doctors with improving the odds of survival for women with heart attacks" he added. Researchers shared data from from the first 1,126 patients of the study presenting with syptoms of heart attack. Early findings demonstrate that women have lower peak levels of troponin than men, contributing to the under-treatment of heart attacks for women. The study was funded by a special project grant from the British Heart Foundation with Abbott providing the ARCHITECT STAT hsTnI assay "Whilst men and women are just as likely to present to the emergency department with chest pain, currently men are twice as likely to be diagnosed with a heart attack. By using the Abbott high sensitive troponin test and different diagnostic thresholds for men and women, the frequency of diagnosis of heart attacks in women increased and was comparable to men," said Dr. Nicholas Mills, one of the key study authors and cardiologist, University of Edinburgh. "The findings of our study, when completed, could change the way we diagnose heart attacks in women, potentially reducing inequalities in the treatment and outcomes, and enabling everyone to receive the best care. ]]> <![CDATA[Medibox to offer immediate medical attention]]> https://biospectrumindia.com/news/95/3422/medibox-to-offer-immediate-medical-attention.html https://biospectrumindia.com/news/95/3422/medibox-to-offer-immediate-medical-attention.html Tue, 17 Sep 2013 16:40:00 +0530 More often than not in an emergency situation like accidents or brain hemorrhage the patients need immediate medical attentions however there is considerable time that is lost to conduct the preliminary checkups that result in untimely death of the patients who could possibly be saved. This is due to lack of communication between different point-of-care devices and clinical information systems. There are too many different types of protocols and interfaces that are being used by hospitals, lack of proprietary data and inability of interoperability. With the introduction and implementation of remote access information devices that are accessible and has the ability of interoperability from any remote place and transmit data at any given time will result in saving lives in case of emergency situation. Prisma Global Limited introduces a product called Medibox or MDS3. Built with advanced Prisma Global technologies inside, this small but highly capable system incorporates leading-edge features. It provides better connectivity between doctor and the patient. Prisma MDS³ allows the doctor to check the measurements whenever they need to access it. In addition to remote accessibility, remote monitoring can support more timely, safe and extensive care of patient's health. Prisma MDS³ connectivity provides vital data to services providers such as Blood Pressure, Blood Glucose, Electronic Cardiogram, Weighing scale, Pace Maker and Body Temperature from patient's residence. On the other side Prisma MDS³ is also connected with server & modem which is again linked with Tele Medicine Centre that shares the data with Tele Medicine Terminal where clinician can easily check patient's measurements. Benefits of MDS3 · It allows to monitor Vital health parameters whenever and wherever you want with online real time information · It allows storing, accessing and retrieving patient information in simpler, faster and convenient way · Dependability and expertise of one person factor is no more existing as the product is user friendly platform and design to get the health status of the patient right on mobile and PC · Fully automated, multiple devices adaptability that offers new level of productivity, safety and quality · The device can be installed in hospitals, ambulances, corporate offices and at home too, as it consumes less energy, no heat emission and workable for 24x7 · Mobile and PC's can be connected through Bluetooth, W-LAN and US ]]> <![CDATA[India, Japan collaborate in key research areas of life sciences ]]> https://biospectrumindia.com/news/95/8012/india-japan-collaborate-in-key-research-areas-of-life-sciences-.html https://biospectrumindia.com/news/95/8012/india-japan-collaborate-in-key-research-areas-of-life-sciences-.html Tue, 17 Sep 2013 10:21:00 +0530 The department of science and technology (DST) alongwith department of biotechnology (DBT), ministry of science and technology and RIKEN, Japan's largest research organization have signed collaborative agreements to launch joint research programs in the fields of biology, life sciences and material sciences. These include genome-related research including systems Biology, computational science including development of bioinformatics tools, detection tools (e.g. spectroscopy) for security and other areas of mutual interest. The Memorandum of Understandings (MoUs) were signed by Prof Ryoji Noyori, president of RIKEN and Dr T Ramasami, secretary, DST and Dr K VijayRaghavan, secretary, DST. This will formally launch the RIKEN- DBT&DST Joint Research activities. The cooperation will facilitate exchange and foster collaborations between Japan and India, in these fields. The laboratory on materials sciences would be a collaboration between Jawaharlal Nehru Centre for Advanced Scientific Research, the Indian Institute of Science (IISc )and RIKEN and will be funded by the DST. The laboratory on neurosciences and developmental biology is collaboration between the National Centre for Biological Science (NCBS/TIFR), the Institute for Stem Biology and Regenerative Medicine (INSTEM) and RIKEN Center for Cell and Developmental Biology, and will be funded by the DBT. Speaking on the occasion Dr K Vijay Raghwan, secretary, DBT said this MoU will usher in a new era of cooperation in the area of innovations and techniques for the agricultural and pharmacological industries in India. "For us at DBT, this MoU will usher in a new era of cooperation in the area of innovations and techniques for the agricultural and pharmacological industries in India, added Dr Vijay Ragwan later. Dr T Ramasami, secretary, DST hoped recognizing the importance of science and technology and the high potential of further cooperation in various areas of research between the DST and RIKEN will further the scope of new inventions. In a public lecture at the National Institute of Immunology to celebrate the signing of the MoU, Professor Ryoji Noyori highlighted the importance of scientific collaborations in reaching the benefits of science to the people at large. Elaborating on his own research on asymmetric catalysis and how he applied it on catalytic hydrogenation, Professor Noyori emphasised that while serendipity is important in scientific discoveries, the young should know that chance only favours the prepared mind. ]]> <![CDATA[Pharma industry feels the heat: registers 1.1% growth ]]> https://biospectrumindia.com/news/95/3420/pharma-industry-feels-the-heat-registers-1-1-growth-.html https://biospectrumindia.com/news/95/3420/pharma-industry-feels-the-heat-registers-1-1-growth-.html Tue, 17 Sep 2013 09:18:00 +0530 A compared to 4.3% growth recorded in November 2012, the domestic pharma market has slid down over last few months and grew by mere 1.1% in August 2013, the market research firm, AIOCD Pharmasofttech AWACS report has revealed. For the month of August 2013, amongst the top 10 companies, Sun Pharma registered the highest growth of 14.9%, Alkem 5.9% and Cipla 4.9%. The multinational drug companies figured among the worst performers with GSK Pharma witnessing a drop of 17.6%, Pfizer of 8% and Abbott 4.6% One of the major reasons for the slowdown seems to be the de-stocking done by the trade and companies due to the uncertainty surrounding the implementation of the new drug pricing control order (DPCO). This is evident from the fact that according to the data, the growth of the DPCO portfolio of products dropped by 12.3% whereas the non-DPCO product market grew by 3.3% resulting in an overall growth of 1.1% for the month of August 2013. The closing stock level, measured as on 10th of every month, stood at 38.8 days as on 10th of April. It however fell to 22.1 days in September 2013. The DPCO 2013 portfolio for GSK Pharma degrew by 30.4% and Ranbaxy degrew by 21.1, whereas Sun Pharma had the least impact with its DPCO 2013 portfolio degrowing at 1.7. ]]> <![CDATA[South-East Asia aims to eliminate measles by 2020]]> https://biospectrumindia.com/news/95/3987/south-east-asia-aims-to-eliminate-measles-by-2020.html https://biospectrumindia.com/news/95/3987/south-east-asia-aims-to-eliminate-measles-by-2020.html Mon, 16 Sep 2013 18:01:00 +0530 Over 70,700 children died of measles in the South-East Asia region in 2011 which was about 45% of global measles deaths. World Health Organization (WHO) estimates that US$ 800 million are needed to achieve this goal by 2020. Now, the countries from this region have jointly expressed their commitment to meet the immediate requirements in tackling the disease. "An estimated 8 million children are not protected against measles in WHO's South-East Asia Region. The measles and rubella vaccines are safe, effective and inexpensive. The administration of a combined measles rubella vaccine can eliminate both diseases cost effectively" said Dr Samlee Plianbangchang, WHO's Regional Director for South-East Asia, "Measles outbreaks are a major development obstacle. I believe that with political will and by focussing on the vulnerable and hard to reach populations, we can eliminate measles and control rubella in South-East Asia Region by 2020." In order to reach the goal of measles elimination and rubella control, governments will need to achieve and maintain 95% population immunity against measles and rubella within each district through routine immunization and/or supplementary campaigns. Countries will also need to develop and sustain a sensitive and timely case-based measles and rubella/CRS surveillance system. The regional network of accredited measles and rubella laboratories needs to be expanded and strengthened. Strategic plans are being developed by all countries in the region. These plans will need to be adequately funded and human resources allocated. Significant progress has already been made toward this ambitious goal. Countries of the region have already achieved a 63% decline in the measles incidence rate from 69.9 per million to 25 per million population between 2000 and 2011. "We have demonstrated that polio eradication is possible even under challenging circumstances. Infrastructure and lessons learned from that historic achievement can play a critical role in achieving measles elimination," said Dr Samlee. Country efforts in the South-East Asian Region have led to a 48% decline in measles deaths between 2000 and 2011. Although the current rate of progress in the region may not be fast enough to achieve the World Health Assembly target of reducing measles deaths by 95% by 2015, the stage is now set for acceleration of measles and rubella control strategies. If implemented this would allow the region to achieve the 2020 elimination goal.WHO is urging partners to reinvigorate commitments and support governments by filling financial and technical gaps to achieve the target of eliminating measles from the region by 2020. ]]> <![CDATA[World's first drug against Diabetic Dyslipidemia launched in India]]> https://biospectrumindia.com/news/95/7238/worlds-first-drug-against-diabetic-dyslipidemia-launched-in-india.html https://biospectrumindia.com/news/95/7238/worlds-first-drug-against-diabetic-dyslipidemia-launched-in-india.html Mon, 16 Sep 2013 17:19:00 +0530 Zydus, an Indian pharmaceutical company, today launched its world's first novel drug 'Lipaglyn', used in treating Diabetic Dyslipidemia. The drug has already been approved by the Drug Controller General of India (DCGI) "Lipaglyn provides patients suffering from diabetic dyslipidemia the option of a once-daily oral therapy, that has a beneficial effect on both lipid parameters as well as glycemic control," said Mr Pankaj R Patel, chairman and managing director, Zydus Cadila. Diabetic Dyslipidemia is a health condition where the patient is a diabetic with high levels of total cholesterol, bad low-density lipoprotein (LDL) cholesterol and triglycerides, and a decrease in the good high-density lipoprotein (HDL) cholesterol concentrations in the blood. Mr Paterl further added, "It has always been our dream to take a molecule right from the concept stage up to its launch. Today, we have realized this dream. It is an important breakthrough and I would like to dedicate this to all the Indian research scientists in the field of drug discovery." ]]> <![CDATA[Sun Pharma gets USFDA approval for Prevacid generic drugs ]]> https://biospectrumindia.com/news/95/8189/sun-pharma-gets-usfda-approval-for-prevacid-generic-drugs-.html https://biospectrumindia.com/news/95/8189/sun-pharma-gets-usfda-approval-for-prevacid-generic-drugs-.html Mon, 16 Sep 2013 17:00:00 +0530 Sun Pharmaceutical Industries Ltd. announced that the US FDA has granted its subsidiary final approval for its Abbreviated New Drug Applications (ANDA) for generic version of Prevacid, Lansoprazole Delayed Release Capsules USP, 15 mg and 30 mg. Lansoprazole Delayed-Release Capsules USP, 15 mg and 30 mg are therapeutic equivalent of Takeda's Prevacid Delayed-Released Capsules. These capsules have annual sales of approximately USD 430 million in the US. Lansoprazole Delayed-Release Capsules USP are indicated for short-term treatment (for 4 weeks) for healing and symptom relief of active duodenal ulcer. In India, the company is a leader in niche therapy areas of psychiatry, neurology, cardiology, nephrology, gastroenterology, orthopaedics and ophthalmology. The company has strong skills in product development, process chemistry, and manufacturing of complex API, as well as dosage forms. ]]> <![CDATA[Rotary's network of members supports Sub-National Immunization Day activity]]> https://biospectrumindia.com/news/95/3954/rotarys-network-of-members-supports-sub-national-immunization-day-activity.html https://biospectrumindia.com/news/95/3954/rotarys-network-of-members-supports-sub-national-immunization-day-activity.html Mon, 16 Sep 2013 16:51:45 +0530 To mark Sub-National Immunization day (SNID) children's 5 years and below were vaccinated against polio, across the country. India is currently running on the third year without a case of Polio and immunization. The SNIDs are scheduled in states like Delhi, Uttar Pradesh, parts of Haryana, Rajasthan, Punjab, West Bengal and one district in Jharkhand, followed by Bihar and Maharashtra. "This sub-National Immunization activity complements the coverage of NID particularly in virus high-risk states and concern areas for the campaign. It is an ongoing effort to ensure no child is left without the vaccine and thus vulnerable to wild Polio virus from within or from outside the country - from polio outbreak countries. Our members and clubs are spreading awareness and supporting this important activity across the country", said Mr.Deepak Kapur, Chirman- Rotary International's, India National PolioPlus Society (RI's -INPPS) India's effort towards achieving the 'Polio-Free stature' has been lauded and recongnized widely. Dr Margaret Chan, Director General, WHO, at the 31st health Ministers' meeting South-East Asia region, said "You did it. For 30 months you have got not a single case of polio. This country is moving in a big way to promote better health to their women and to their children." While urging nations of the region to adopt universal healthcare access for all, she added "I want to urge countries in this region, please continue to champion universal access to healthcare. That is the platform to deliver healthy human capital that are important for sustainable development in the future." Taking lessons from India's success, the GPEI's robust five year plan (2013-2018) against polio has incorporated the key learning. India is being commended as the nation that could guide the three endemic nations - Pakistan, Afghanistan and Nigeria - to attain similar success through their experience. ]]> <![CDATA[Link laboratories to farm lands : Modi]]> https://biospectrumindia.com/news/95/5836/link-laboratories-to-farm-lands-modi.html https://biospectrumindia.com/news/95/5836/link-laboratories-to-farm-lands-modi.html Mon, 16 Sep 2013 14:51:00 +0530 Addressing the valedictory session of the first ever Vibrant Gujarat Global Agriculture Summit - 2013 at Mahatma Mandir of Gandhinagar, Gujarat chief minister Mr Narendra Modi said, "With the successful completion of this global summit Gujarat has made humble yet historical attempt to link entire country's agriculture sector." Mr. Modi called for different linkages for the larger benefit of the agriculture sector i.e. creating interlinking of river water grid, agro market linkages, agro-tech lab to land linkages and gave the formula of creating ago-credit linkages. Mr Modi also advocated for focusing on agriculture with three sub-sections and diversification of the risk. This will give a boost to overall development prospects of this sector. These areas could be subdivided into farmers focusing on traditional farming, dairy-animal husbandry-fisheries and poultry, and agro forestry to cultivate trees which have high value in timber markets. Gujarat chief minister said it is high time that farmers do not waste single inch of land available to them for cultivation. He said, "Portion of land going waste between two farms could be used for agro forestry and this will create an economic return cycle for them." Also sea weed farming could give a major boost to those living on the coastal belt of the nation. Chief Minister proposed creation of all-round market linkages. He said, "In entire nation, farmer is the only manufacture who does not have right to decide the selling price of his produce. And creation of market linkage using latest technologies will provide major boost to the sector." Emphasizing the need to link laboratories and farm lands, Mr Modi said, "It will be very fulfilling if agriculture scientists and their research knowledge is able to reach the actual farmland, and in turn bring more benefits to the farmers." He said Gujarat has already taken an initiative to bring so many new things to its farmers by organizing Krushi Mahotsav in the state. Mr Modi announced that his government will publish all the success stories of the farmers on its website to give their innovation wider reach and encourage more fruitful experiments in the field. Also Mr Modi demanded that central government make necessary attempts to encourage more unique farm researches in the country. Mr Modi said, "If we increase agricultural produce by two fold, we will be able to feed entire India and if we make it three fold, we will feed entire World. Farmers of India are quite capable of doing it and I have confidence in them." Other dignitaries who graced the valedictory session include Mr Anders Adamisen, counselor food and agriculture, Bolivia ambassador to India Mr. Jorge Cardenas Robles, representatives of Madagascar Embassy, Gambia High Commission and Malawi ambassador to India Dr. Perks Ligoya, parliamentary secretary of Nagaland Agriculture Board, additional secretary Department of Agriculture & Cooperation, Ministry of Agriculture, Mr. Ashish Bahuguna and Dr S Ayappan, members of state ministry, Mr. Varesh Sinha - Chief Secretary and others officials. ]]> <![CDATA[New hybrid tomato yields up to 19 kgs per plant]]> https://biospectrumindia.com/news/95/6714/new-hybrid-tomato-yields-up-to-19-kgs-per-plant.html https://biospectrumindia.com/news/95/6714/new-hybrid-tomato-yields-up-to-19-kgs-per-plant.html Mon, 16 Sep 2013 14:29:00 +0530 After five long years of painstaking research, scientists at the Indian Institute of Horticultural Research (IIHR) have developed a new hybrid tomato variety called 'Arka Rakshak', which has recorded yields of up to 19 kilos of tomatoes per plant. "Arka Rakshak was cultivated by precision farming practices, which essentially consisted of drip irrigation, fertigation and black-silver polyethylene mulch. Water was supplied through drip irrigation on daily water loss basis. This hybrid is resistant to three different plant diseases including tomato leaf curl virus, bacterial wilt and early blight. It can be grown throughout the year in moderate climate areas. Its cost of cultivation is very low," said Sadashiva A T, principal scientist & head, division of vegetable crops, IIHR. The drip irrigation method of cultivation consumes only about 50 percent of water compared to normal irrigational practices. The nutrients for these crops is supplied by dissolving the fertilizer in irrigation water (fertigation). Dr Sadashiva said that, Mr Chandrappa, a farmer from Devasthanadahosalli near Chikkaballapur district had harvested close to 19 kilos of tomatoes per plant. "It took about six months for me to cultivate these tomatoes. I have been able to sell them off in the market without any hassles," said Mr Chandrappa. Another principal scientist, Dr Shankara Hebbar, division of vegetable crops, IIHR, commented on the factors that led to this hybrid's successful cultivation. He said, "Fertigation ensured the complete solubility of fertilizers, making all the nutrients completely available for the plant. This prevented the plants from wilting. Thus, the crops were under less stress. The black-silver polythene mulch reduced the growth of weeds, prevented leaching of nutrients during rainfall, and maintained the friable nature of soil. Polyethylene mulch also helped in repelling the insects during early growth stage because of the reflection of sunlight, thus reducing the transmission of viral diseases." To cultivate this hybrid tomato species, farmers essentially would need to have their own land, assured irrigational facilities and good labor. The seeds will be available at IIHR. Farmers can approach them for seeds and even visit IIHR campus to have a look at its cultivation methods, said Dr Sadashiva. According to Dr Sadashiva, Arka Rakshak yields seem to be very good. Normally, the plant is claimed to yield up to 6-8 kilos of tomatoes. Dr Sadashiva added that these plants require very less number of fertilizer sprays than that is usually needed. These tomatoes have been accepted in the market in terms of color, size, transportablility and storability factors. At room temperature, Arka Rakshak has a shelf life of 15-20 days. Dr Sadashiva confirmed that the tomato hybrids were bred only by conventional breeding procedures and that no genetic modifications were carried out on it. Regarding the growth of Arka Rakshak, Dr Sadashiva added, "Arka Rakshak is a new hybrid. We don't know how different the viruses are in various parts of the country. We need to wait and see how the plants respond. In summer, the yields may slightly reduce though it is disease resistant. Farmers need to be cautious of environmental factors. So far we've successfully grown this hybrid variety in Hassan, Mandya, Doddaballapur, and parts of Kolar." Commenting on the health benefits of Arka Rakshak, Dr Sadashiva added, "These tomatoes have impressive qualities including color, firmness, shape, size and health benefits. Arka Rakshak has a deep red color due to the presence of Lycopene pigment in high quantities, which is much higher compared to normal tomatoes. Lycopene is a good anti-oxidant and anti-cancerous. It is also rich in Vitamin C, which is good for overall human nutrition." The tomatoes are currently supplied to other cities like Delhi, Mumbai, Kolkata and Chennai. ]]> <![CDATA["We are developing joint ventures to build and operate bioenergy zones"]]> https://biospectrumindia.com/interviews/95/6955/we-are-developing-joint-ventures-to-build-and-operate-bioenergy-zones.html https://biospectrumindia.com/interviews/95/6955/we-are-developing-joint-ventures-to-build-and-operate-bioenergy-zones.html Fri, 13 Sep 2013 17:36:00 +0530 Though VayuGrid's initial projects are in emerging economies, it is seeing increasing demand for projects in developed nations. This start-up has focused its efforts on building bioenergy plantations around VayuSap in markets such as Asia, Africa and the Middle East, besides India. Mr Douglas Peterson, CEO, VayuGrid, in an interview to BioSpectrum's Raj Gunashekar shares more insights about the company's India operations. How do you see India as an emerging/growing market in the biofuel sector? The challenge for biofuels has always been finding agriculture solutions that can economically scale without competing or damaging other concerns, be it with food, forests, or marine ecosystems. India being a global leader in oilseed production, along with India's large tracks of unproductive lands, along with India's native plant species that enjoy arid climates and marginal soils, make for the ideal conditions for significant developments in biofuels. In fact, India has a rich history in biofuels, with biofuels being used for thousands of years for lighting, cooking, and even more recently for operating machinery. There is an opportunity for India to be a leading biofuel producer with biodiesel, green coal, and a carbon sequestration model, and with millions of farmers as beneficiaries. Tell us something about creating BioEnergy Zones in Haiti? How did it all begin? VayuGrid's partner for community scale biodiesel refining in India, The BioCube Corporation from Canada, was working in Haiti and introduced VayuGrid to the key players in Haiti. We quickly developed a partnership with Sonamar S. A. who has been working post the recent Haiti tragedies to bring technology and agriculture projects to help accelerate the rehabilitation of the environment and develop opportunities to drive economic growth. Sonamar recently signed an agreement with the Ministry of Agriculture in Haiti for the development of biofuels and has access to significant land in Haiti - both arable and non-arable. Jointly VayuGrid and Sonamar developed a plan for implementation of BioEnergy Zones in multiple stages to meet the needs of the Haitian people, environment, and economy. Do you have any plans in creating BioEnergy Zones in India? Yes, we just started a project with a mining company in Rajasthan to establish a large BioEnergy Zone as part of their mining reclamation and CSR statutory compliance. Over the next several years we expect this to scale to thousands of acres. We are also in discussion with several other India mining companies across India, based on the unique properties of VayuSap to remediate the land, produce clean energy, and develop a sustainable platform for jobs to remote communities. Therefore, all the environmental and community compliances are addressed in a financial model that brings 60 years of benefits to the mining operations. Do you think the concept of biofuels is still at an embryonic stage in India? Explain. The technology concept is well beyond embryonic as it has been well researched and developed to a commercial scale. Millions of elite biofuel trees are being produced today and government, industry, and non-profits have independently validated the economic, environmental, and social benefits. The implementations themselves are still embryonic in terms of the scale we expect them to achieve over the next 5 years. For instance, in the mining sector alone, we see potentials of millions of reclamation acres of BioEnergy Zones producing tens of billions of liters of biodiesel, whereas today we are working in the thousands of acres. This is precisely the opportunity since India has the unproductive, unused land assets and the right biofuel platform. If India doesn't take the opportunity, other countries will execute and then there is no turning back. What are your major challenges in growing energy crops in India? The two major challenges we face are, first the traditional competition between food and fuel, and second the traditional reliance of biofuels on government subsidies. The VayuSap solution was carefully selected and validated for growing on lands not suitable for food crop, thus avoiding the food vs fuel debate. Further, VayuGrid has carefully validated the economies of scale of VayuSap through various independent government research and industry. Thus, the model is assured to achieve the profits without subsidies which is a first for the industry. How can we advance and encourage the use of biofuels in developing nations like India? Having come from the IT industry, the IT industry flourished in India when there was a strong educational base, a global and open marketplace to which India could quickly participate, and minimal protectionist barriers. Biofuels can similarly flourish when there is education to displace the mis-perceptions, an open and global marketplace to exchange biofuel commodities, and minimal protectionist barriers. Tell us something about Elite Pongamia (VayuSap) and Pongamia biofuels. How is it different from normal Pongamia? We look at this both from the technology and the business standpoint. The agro-technology of VayuSap is based on 25 years of research by our chief scientist, Dr. MVR Prasad in India, Africa, and Central America. He developed elite varieties of Pongamia which have half the gestation period and four times the output as average Pongamia trees. The VayuSap trees will start yielding in year 3 and produce predictable high yield for over 60 years. The business innovation around VayuSap improves the ability to scale the supply chain through a reduced risk model by linking the downstream demand to the upstream supply through demand agreements. This model de-risks the downstream energy needs by providing a known energy cost, and de-risks the plantation by assuring an uptake on the plantation produce. Can you explain the environmental friendliness of VayuSap Biofuels? VayuSap biofuels as an energy source do not increase carbon in the atmosphere because of the unique properties of the VayuSap to perennially produce fuel, to extract both carbon and nitrogen from the atmosphere at very high levels, to avoid the use of chemical fertilizers, and to process into biodiesel without the use of petroleum. Additionally, the VayuSap biofuels eliminate the sulfur and ash which are released when burning diesel and coal. Thus the atmosphere is significantly improved through VayuSap biofuels as there is a reduction in greenhouse gasses, particulates, and acid rain. VayuSap also improves the soil while growing the biofuels. The trees are an inclusive species that fix nitrogen into the soil, thus increasing soil productivity. Further, VayuSap is a very effective plant for phytoremediation of mined and landfill soils, and other similar land reclamation projects. The trees will re-establish a natural ecosystem of plants and micro-organisms in the soil while the damaging hard metals are taken up and dissipated through natural means. How do you intend to work with the Indian rural communities, government and industry in the area of biofuels? We are developing joint ventures (JV) to build and operate the BioEnergy Zones with all partners having an equity stake in the success of the projects. The rural communities, as JV partners, are key for building and operating the plantations to scale. Government, as a JV partner, provides land and policies and oversight to meet standards of operation. And industry, as a JV partner, provides the capital and demand for the yield of the BioEnergy Zones. Thus all three are critical to the long term success and value generation. Can you tell us about how you worked with farming communities oilseeds across Karnataka's village? We have been working with farming communities across Karnataka for over 5 years. We have worked to improve their production of oilseeds through methods developed by Dr. Prasad. We also use rural villages in Karnataka exclusively today for production of our VayuSap saplings. We have found them to be productive and careful in working with VayuGrid as we have scaled over the last several years. Can you discuss about the 'Triple Bottomline'? The first bottom line is the economic bottom line, which is the standard bottom line in business. The key for the economic bottom line is to assure that all players in the BioEnergy Zone Value chain - the farmers, processers, investors, etc., all operate at a profit without government subsidies. The second bottom line is the environmental bottom line, which is the measurable environmental benefits of the BioEnergy Zones. The environmental benefits are measured in the atmosphere, soil, and water. The third bottom line is the social bottom line, which is the measurable social benefits to the rural communities. The BioEnergy Zones convert unproductive lands to productive land and provide jobs, entrepreneurial opportunities, and equity for over 60 years to the rural communities. VayuGrid is focusing its efforts on building BioEnergy Plantations around VayuSap in markets such as Asia, Africa and the Middle East. Is VayuGrid only targeting emerging economies and developing nations? If yes, why? What about developed nations who tend to contribute more carbon footprints? Independent research shows that two-thirds of the increased global greenhouse emissions over the next 10 years is expected to come from emerging economies. Additionally, it has been shown that lack of energy access is a significant inhibitor of grown in emerging economies. So taking action with emerging economies to support the economic growth in a socially responsible model, while at the same time heading off the increased emissions is something that can be accomplished. Therefore, because of these factors many of VayuGrid's initial projects are in emerging economies. However, VayuGrid also is seeing increasing demand for projects in developed nations. The biofuel blending mandates in the Americas and Europe account for 94 percent of the total biofuel blending mandates across the globe. Biofuel projects are being developed to meet these mandates, while at the same time meeting non-biofuel related targets. For instance, phytoremediation, organic fertilizers, jobs and other BioEnergy Zone properties in combination make for a multi-dimensional benefit in developed economies similar to emerging economies. What is the viability of biofuels vs fossil fuels? Can biofuel manufacturing be cheaper than extracting fossil fuels. Discuss. The costs of extracting fossil fuels continues to increase, as they go deeper in the ocean and to more extravagant processes to extract the oil. Today the fossil fuel extraction costs are approaching US $30 per barrel. At the same time, the costs for producing biofuels is dropping quickly. For instance, just this year, the cost of the equipment to process vegetable oil to biodiesel has dropped in half. Therefore, as the feedstocks, such as VayuSap are becoming more productive, the costs of manufacturing biofuel is also approaching the $30/barrel. The net result is biofuels are now competing at a level playing field with fossil fuels, so production can scale at a much faster rate than in the past. Are biofuels/bioenergy here to stay? Discuss. Biodiesel has grown at an annual rate of 24 percent over the past 4 years and analysts expect it to continue a strong growth rate over the next 10 years. There are blending requirements for biofuels in 52 countries today which will increase the annual demand to over 35 billion gallons of biofuels in the next 9 years. Therefore, biofuels are definitely here to stay. Even if solar and wind energy were perfected to their optimal efficiency, it would not eliminate the need for biofuels. What are your recent collaborations in India and other countries? Other than the Haiti project with Sonamar S. A. which we just announced, we have also been doing projects in Ethiopia, Kenya, Zambia, and Kuwait. The Zambia project is being funded by EU countries to develop a template for scaling VayuSap across the region. Kenya has started investing in biofuels to bring jobs and energy. We are also working on new strategic projects in the US and Africa that we expect to announce soon. How is the future outlook of biofuels in India and other countries? What is the current status of fossil fuel depletion across the globe and how can biofuels be a better alternative? Biofuel accounts for 5 percent of the global fuel demand today, and we expect it to increase to 17 percent by 2030. In India, domestic fossil fuel production only accounts for 25 percent of the nation's consumption. As part of the national biofuels policy, the Government of India has implemented a blending target of 20 percent by 2017, where it is at 3 percent today. The policy also calls for an approach to develop biofuels which are non-food feedstock and on barren, non-arable lands. Thus, we see significant growth inside of India and across the globe for biofuels. Are biofuels in competition with other renewable energies like solar, wind, tidal and geothermal? No, they are not in competition. They are complimentary as a portfolio. Today, there are a variety of fuels - from a variety of fossil fuels, to nuclear and hydro, which serve a variety of energy needs based on application, costs, transportability, and a number of other factors. We expect the same to happen in the renewable energy space, where there will be some application which are more effective for one platform, while some applications will be more effective for others. We welcome all the developments in this space. ]]> <![CDATA[Biocon markets CytoSorb in India]]> https://biospectrumindia.com/news/95/5989/biocon-markets-cytosorb-in-india.html https://biospectrumindia.com/news/95/5989/biocon-markets-cytosorb-in-india.html Fri, 13 Sep 2013 16:45:08 +0530 Biocon has entered into a strategic partnership with CytoSorbents Corp., having exclusive commercialization rights for CytoSorb in India and other emerging markets. However, the financial terms of the agreement were not disclosed. Kiran Mazumdar Shaw, chairperson and managing director of Biocon said, "We believe our partnership with CytoSorbents will enable us to address the huge unmet need of sepsis management in India and emerging markets. CytoSorb is a 'first-in-class'therapy that can provide an effective solution to physicians to treat critically ill patients suffering from sepsis. This move reflects our commitment to bring differentiated products to India that will help address various healthcare challenges faced by millions of patients in our country." According to Biocon, CytoSorb is a safe and effective extra-corporeal cytokine filter, designed to target prevention or treatment of organ failure, which is found to be the cause for half of all deaths in intensive care units (ICUs). When left unchecked, 'cytokine storm' caused by excessive cytokine production causes massive inflammation, organ failure and death in common life-threatening conditions such as sepsis, burn injury, trauma, lung injury, and pancreatitis. "We are very pleased to enter into this initial agreement with Biocon on World Sepsis Day to bring our potentially life-saving therapy to the people of India and other emerging markets. Unlike any other previous approach, CytoSorb attacks sepsis from multiple angles by reducing cytokine storm and deadly bacterial toxins, and directing immune cells to target the infection while avoiding damage to otherwise healthy organs," said Dr Phillip Chan, chief executive officer and president of CytoSorbents. CytoSorb is claimed to bear the CE Mark regulatory approval, and is clinically proven to control cytokine storm in critically-ill patients by reducing key cytokines in blood by 30-50 percent. It also works easily with standard dialysis machines used in hospitals, said the press release. It is said that Biocon and CytoSorbents will initially focus on treating sepsis, which is the end result of an excessive immune response to an infection. By amalgamating Biocon's critical care antibiotics in treating the infection, which is compatible with CytoSorb therapy in modulating the immune response, the two companies are aiming to provide a holistic solution for sepsis management in the market. Adds Mr Rakesh Bamzai, president marketing, Biocon, "CytoSorb is a safe and well-tolerated innovative therapy for managing cytokine storm in critically ill patients. Very high levels of cytokines are known to cause multiple organ failure, which is often life threatening. Through CytoSorb, we offer a promising treatment option to high risk patients in their fight against sepsis and other critical illnesses." Severe sepsis and septic shock are considered to be the major causes of morbidity and mortality worldwide. It is also a leading cause of death in non-coronary ICUs and the 11th leading cause of death overall. India being the second most populated country in the world, more than one million estimated new cases of severe sepsis are treated in the Indian ICUs each year, accounting for one out of every four patients in the ICUs. Mr Chris Cramer, vice president of business development, CytoSorbents, expressed, "This partnership has the potential to change the treatment of critical care illnesses such as sepsis, and we are confident that our work will lay the groundwork for an expanded partnership in the future." According to a recent nationwide study of Indian Intensive Care Case Mix and Practice Patterns (INDICAPS) involving over 124 ICUs across 17 states in India, mortality was found to be as high as 46 percent in patients with septic shock and 42.2 percent overall in septic patients, compared with 17.8 percent mortality for ICU patients who did not develop sepsis. ]]> <![CDATA[Not yet impacted!]]> https://biospectrumindia.com/features/95/3409/not-yet-impacted.html https://biospectrumindia.com/features/95/3409/not-yet-impacted.html Thu, 12 Sep 2013 12:21:00 +0530 With the dollar-rupee parity crossing 66 per USD, there has been a lot of concern on its impact on the industry. The trend on this plummeting reality is mixed. The biotech and pharma companies are export oriented and less dependent on imports. "The depreciating rupee will result in a gain to these companies in the short term. However, in the medium term as a result of inflation coupled with customer expectation of lower prices, the margins will be under pressure," responded Mr KV Balasubramaniam, managing director, Indian Immunologicals Ltd., This sector including the pharma industry accounts for a considerable 11 percent of exports from India. Growing at an average rate of 20 percent (YoY exports) in the last two years. The Ministry of Commerce has set up a target of $25 billion for Pharmaceutical exports for the year 2013-14. The volatility of the Indian Rupee is a real long-term concern for India now. The movement of currency is a trailing indicator for the stability of the government it represents. Global MNCs in pharma, biotech, and life sciences will hedge its position within India, relative to fellow rapidly emerging nations that clearly indicate a longer-term stability profile. Adds Mr Nicholas Mitchell, managing director, Phenomenex India, "As one of India's most rapidly emerging sectors (pharma) behind IT and BPO, we must unite to lobby for policy changes that promote stability not only for our sector, but for all of those India is relying upon to advance its position on the global stage." Says Mr Siddharth Dhodi, senior manager lifesciences, Yes Bank, "Indian Pharmaceutical is likely to benefit from the rupee vulnerability. The large-cap pharma companies in India are primarily export oriented companies and would witness an increased top-line growth in rupee term. This would include Sun Pharma, Lupin, Dr Reddy's and Cipla. "However, companies with substantial foreign liabilities in the form of External Commercial Borrowings (ECBs) will experience a negative hit owing to market-to-market (MTM) losses. In addition to this, the falling rupee imposes a higher burden on interest charges and repayment obligations." Some pharma companies import Active Pharmaceutical Ingredients (APIs), excipients, and other raw materials from China. As importing raw materials from China becomes expensive, the margins without a proper hedging strategy gets negatively affected. For example, Sun Pharma with about 75 percent of international sales revenue has experienced a positive effect on the margins. Sun has the policy of keeping its receivables unhedged, which has contributed to the upside. In addition to this, Sun does not have any forex liabilities in its books. On the other hand, companies like Aurobindo Pharma, where the debt is primarily denominated in foreign currency has had to register a forex loss owing to restatement. Mr Shrikanth, industry manager, business & financial services, Frost & Sullivan, also agrees with the trends. "The pharma industry is more of an export industry and so the depreciation of the Indian rupee is a good sign as it increases the cash flow. On the flip side, some companies have foreign debts which means they will be paying back at higher cash rates. "The biopharma industry is not going to face much problems because the industry derives lot of revenues from the US market. Right now, the situation is very favorable for biotechnology and pharmaceutical industry because they gain revenues from the exports. In the future, if they are looking to hitch their revenues and their interest rates, they might need to shell a lot more money than earlier," he added. For foreign investors, under this slowdown, it becomes easier to acquire Indian companies. There are many companies who are looking out for healthcare companies in India. Thus, it becomes favorable for exporters. For foreign investors time is money. If there is a military strike on Syria by US, it is going to increase the crude oil prices, which in turn is going to result in higher import prices. Mr Shrikanth believes that the government should welcome deposits from NRIs at this critical time. No matter what the Indian government does, investors are going to wait and watch the situation as it unfolds, till the culmination of the elections next May. ]]> <![CDATA[MED-EL Founder Dr. Ingeborg Hochmair to Receive Prestigious Lasker Award ]]> https://biospectrumindia.com/news/95/6890/med-el-founder-dr-ingeborg-hochmair-to-receive-prestigious-lasker-award-.html https://biospectrumindia.com/news/95/6890/med-el-founder-dr-ingeborg-hochmair-to-receive-prestigious-lasker-award-.html Thu, 12 Sep 2013 10:44:00 +0530 Worldwide hearing implant leader MED-EL Medical Electronics announced that Founder and CEO Ingeborg Hochmair, PhD, has been selected to recieve this year's prestigious Lasker-De-Bakey Clinical Medical Research Award for the development of the modern cochlear implant, a device that restores hearing to individuals with severe-to-profound deafness through electrical stimulation of the auditory nerve. She will share the award with Graeme M. Clark (Emeritus, Univ. of Melbourne, Australia) and Blake S. Wilson (Duke University, Nc, USA). This highly respected scientific award honors scientists whose contribution have improved the clinical treatment of patients. Ingeborg Hochmair, a PhD in electrical engineering, is being recongnised for her early contributions to the field of cochlear implants starting with the development of the world's first multi-channel microelectronic cochlear implant that was implanted in Viena in 1977. With a modified version of this device, the next milestone was reached in 1979: the understanding of words and sentences without lip-reading in a quiet environment via a small, body worn sound processor. intense and continous innovation followed, including the development of the world's first behind-the-ear (BTE) cochlear implant audio processor in 1991. "Many of these achievements were attained with the shared commitment of my husband and closet collaborator, electrical engineer Erwin Hochmair, and with other outstanding partners, such as basic researchers, surgeons, clinicians, and co-workers at MED-EL and, ultimately, the end-users of the devices," said Dr. Hochmair. Dr. Hochmair and the entire MED-EL family extended congratulations to her fellow research Award recipients, Graeme M.Clark and Blake S. Wilson. "I'm extremely gratified that our life's work is being recongnised in such a prestigious manner," said Dr. Hochmair. However, I'm even more pleased that this award will raise awareness for the entire field of cochlear implants and its importance as a treatment for small children born with severe to profound hearing loss, up to and including older adults who lose their hearing later in life. in so many ways, our work has just begun. Technological advances have accelerated our research at an unbelievable rate. we are on the threshold of breakthroughs that would have been considered dreams not long ago." she added. The award ceremony will take place in New York city Friday, September 20, 2013. ]]> <![CDATA[Chances of having a healthy baby improves with new genetic screening]]> https://biospectrumindia.com/news/95/8009/chances-of-having-a-healthy-baby-improves-with-new-genetic-screening.html https://biospectrumindia.com/news/95/8009/chances-of-having-a-healthy-baby-improves-with-new-genetic-screening.html Thu, 12 Sep 2013 10:29:00 +0530 Couples facing infertility problems could now improve their chances of having a healthy baby with new genetic screening and diagnostic services. These not only promise to increase their chances of a successful parenthood, but also reduce the number of IVF cycles that they might otherwise need to be subjected. The first of its kind, Iviomics lab, offers international technology for a safer, faster and more accurate method of identification and selection of healthy, disease-free embryos. According to the research performed by Iviomics, almost 80% of the embryos turn out to have chromosomal abnormalities in pregnancies occurring in women above 35 years who are undergoing infertility treatment. FISH (Fluorescent In-situ Hybridization) has been the choice of technique used for the screening of the same. However this technique can analyze only a selected number of chromosomes (9-12 out of total 24). The newly introduced genetic screening technique called array CGH (Comparative Genomic Hybridization) can screen all the 24 chromosomes and hence increase the ongoing pregnancy rate in all the groups of patients with problems like advanced maternal age (women getting pregnant at 35 years or above), recurrent miscarriage ( more than or equal to 3 pregnancies that end in miscarriage ) etc. Iviomics India Lab Manager, Dr Pere says "In couples with recurrent miscarriages, 80% of the embryos are chromosomally abnormal and up to 15% patients have all the embryos which are chromosomally abnormal. These couples therefore would never have a chance of conceiving a healthy offspring. Previously, the IVF clinics had no choice but to repeat the IVF cycles till there was a success or otherwise. Now, after Array CGH analysis only those embryos which are chromosomally normal are transferred to the uterus which increases the success rate of pregnancy and implantation. This simultaneously reduces the risk of miscarriages or having a live born child with chromosomal abnormality like Down's syndrome." "Additionally, the lab also provides PGD services (Preimplantational Genetic Diagnosis) which can help couples with a personal or family history of genetically inherited disorders to have healthy babies. Iviomics has a developed a PGD protocol for more than 150 single gene disorders," added Dr. Pere. Another service called ERA (Endometrial Receptivity Array) helps the IVF clinicians to find out the most suitable time for the transfer of embryo in the uterus. Endometrium is the inner lining of a uterus which is made up of a dynamic tissue that helps embryo to get implanted in the uterus. In this way, chances of any loss of a good quality embryo are reduced. Histological markers have been outweighed by the molecular diagnostic tool patented by Iviomics, because of the accuracy and reproducibility of the latter. This service helps to identify the personalized window of implantation (the period with highest receptivity of endometrium for an embryo) in patients who are facing repeated implantation failures (more than or equal to 3) in spite of having a good quality embryo. The lab also offers NACE (Non Invasive Analysis for Chromosomal Examination), which has a 99.9% detection rate for Down's syndrome Patau's and Edward's syndrome which is achieved by using an advanced technology called Massive Parallel Sequencing. This is a non-invasive alternative to invasive procedures like amniocentesis in which there are fair chances of fetal loss. (In amniocentesis, a needle is inserted inside the uterus to withdraw amniotic fluid for examination of amniotic cells)This is performed on the cell free fetal DNA which is extracted from the mothers blood via simple blood draw, hence posing zero risk to the baby. It is done in the 12th week of pregnancy, hence giving enough time for the couple to be counseled accordingly. ]]> <![CDATA[Jubilant Clinsys launches TrialStat Orbit EDC]]> https://biospectrumindia.com/news/95/3445/jubilant-clinsys-launches-trialstat-orbit-edc.html https://biospectrumindia.com/news/95/3445/jubilant-clinsys-launches-trialstat-orbit-edc.html Wed, 11 Sep 2013 17:09:00 +0530 Recently TrialStat Orbit is an Electronic Data Capture soluTrialStat, part of Jubliant Clinsys Inc., a subsidiary of Jubliant Life sciences has launched the much anticipated TrialStat eClinical suite. Nayan Nananvati, CEO of Jubliant Clinsys Inc commented on the launch of TrialStat "TrialStat eClinical suite is an innovative cloud-based platform providing an advance set of features with a strong focus on usability enabling the power to manage your trial efficiently and providing our clients a robust platform for improving data collection and study management." Ion used by a wide range of pharmaceutical and CRO customers worldwide, being utilised for complex Phase II and III studies. ORBIT was the industry's first EDC platform to allow all aspects of a study to be configured, deployed and managed through a browser interface, enabling customers to start their studies quickly and cost-effectively. Orbit also includes advanced integrated features such as IWR, Imaging, Coding and Electronic Patient Access. It has been successfully deployed in over 350 global studies. TrialStat CTMS is a Clinical Trial Management System designed to be fully integrated with Orbit, allowing for data entered into Orbit to trigger actions in the CTMs, thereby increasing visibility for critical management areas such as patient enrollment, monitoring management, and site payments. TrialStat Portal is a central data base designed to provide seamless integration with all TrialStat products creating the ultimate study management tool through real-time visualization of your study data. The portal can be accessed by study sites, sponsors and CROs for central communication and critical decision making. This eClinical suite uses the latest in today's technology to revolutionize and redefine integrated clinical software. TrialStat enable you to use one system for all clinical phase including, form build your own EDC for Phase I; to advance EDC, CTMS, and Portal Functionality for Phase II and III; to flexible electronic patient access for utilizing late phase. TrialStat eClinical Suite is a fully scalable solution that deploys trials in 2-4 weeks, recongnizes efficiencies, and provides one system that enables you to visualize and enhance your clinical development lifecycle. ]]> <![CDATA[Piramal Healthcare to invest $11 mln in hormonal healthcare production]]> https://biospectrumindia.com/news/95/7761/piramal-healthcare-to-invest-11-mln-in-hormonal-healthcare-production.html https://biospectrumindia.com/news/95/7761/piramal-healthcare-to-invest-11-mln-in-hormonal-healthcare-production.html Tue, 10 Sep 2013 18:05:00 +0530 Piramal healthcare today announced that it is to invest 11 million USD at its Morpeth, Uk facility to triple the production capacity for hormonal products, including contraceptive pills and hormone replacement therapies. The expansion which has been commissioned in response to customer demand and new business gain, will see the Morpeth site's production capacity increase by around 2 billion tablets per annum. Work on the new suite, which will house formulation, packaging coating and tableting equipment, will commence at the end of 2013, with mechanical completion anticipated within 12 months and full operations expected to begin following a 6 month validation period. The latest investment follows Piramal healthcare's recent announcement that it is to invest 2.5 million USD at its FDA approved Grangemouth, UK, site to upgrade one of its antibody drug conjugate (ADC) manufacturing sites, from clinical phase to commercial grade, in response to customer demand. The upgrade will give Piramal two commercial grade ADC suites at the Grangemouth facility, while retaining clinical phase manufacturing capacity in other suites on site. "The production of hormonal products is highly specialised, niche area," commented Piramal Enterprises' Executive Director and COO, Vijay Shah. "The Morpeth facility is our Centre of Excellence for these products and this expansion will greatly enhance our offer and potential for growth in this space. The hormonal sector currently represent a USD 11 billion market globally and is growing at a pace of 4% to 5% annually. With major competitions limited to a small number of CMOs in Europe, Piramal sees major opportunities for growth in this area given our vast experience in this field, which spans more than 40 years." The 13,000 sq ft Morpeth facility also houses Active Pharmaceutical Ingredient (API) production, general solid formulation production, and a range of clinical trial supply and research facilities, and was acquired from Pfizer in 2006. Piramal Healthcare provides Late Phase API services on an integrated manufacturing model across North America, Europe and Asia. All its facilities manufacturing commercial phase APIs have been GMP certified and possess API finishing facilities. Piramal has a successful performance record of over 40 years for the supply of APIs to the US and European markets from its facilities located in Canada, India and the UK. With a reactor volume exceeding 500 KL, including pilot plants and multi-purpose plants, Piramal Healthcare is capable of executing the extensive API requirements of its clinet base. ]]> <![CDATA[ASLAN Pharmaceuticals wins Red Herring Top 100 Asia Award]]> https://biospectrumindia.com/news/95/3372/aslan-pharmaceuticals-wins-red-herring-top-100-asia-award.html https://biospectrumindia.com/news/95/3372/aslan-pharmaceuticals-wins-red-herring-top-100-asia-award.html Tue, 10 Sep 2013 17:52:36 +0530 ASLAN Pharmaceuticals has won the prestigious Red Herring Top 100 Asia Award 2013 which recongnizes the most innovative and promising private companies in the region. ASLAN was the only clinical stage life sciences company in Asia to receive the award this year. "ASLAN set out to transform the way we develop drugs for life threatening disease, particularly those more prevalent in Asia. In three years we have built a rich portfolio of drugs in oncology and inflammation, each of which has the potential to be a major new medicine.This award recongnises the creative approach ASLAN's team has pioneered in Asia" express Dr Carl Firth, CEO. "Choosing the companies with the strongest potential was by no means a small feat," said Alex Vieux, publisher and CEO of Red Herring. "After rigorous contemplation and discussion, we narrowed our list down from hundreds of candidates from across the Asia to the Top 100 winners. We believe ASLAN Pharmaceuticals embodies the vision, drive and innovation that define a successful entrepreneurial venture. ASLAN should be proud of its accomplishment, as the competition was the strongest it has ever seen" Mr Vieux added. Red Herring's editorial staff evaluated the companies on both quantitative and qualitative criteria, such as financial performance, technology innovation, management quality, strategy, and market penetration ]]> <![CDATA[Declaration to combating high blood pressure]]> https://biospectrumindia.com/news/95/3378/declaration-to-combating-high-blood-pressure.html https://biospectrumindia.com/news/95/3378/declaration-to-combating-high-blood-pressure.html Tue, 10 Sep 2013 17:05:00 +0530 The health ministers committed to according high priority to the prevention and control of high blood pressure and to strive towards measurable reduction in the prevalence of hypertension in the Region by 2025. Hypertension is the leading risk factor for mortality worldwide, causing 9 million deaths each year. In South-East Asia every third adult is affected by hypertension, with an increased risk of heart disease, stroke and kidney failure. The poor are disproportionately affected by hypertension. India hosted the thirty-first meeting of ministers of health of the WHO South-East Asia region today. The ministers reviewed progress on decisions and recommendations from previous meetings of ministers of health. The New Delhi declaration on high blood pressure was adopted by the Health Ministers in recognition of the fact that while noncommunicable diseases account for 55% of the 14.5 million total deaths in the Region; cardiovascular diseases alone account for 25% of all deaths (3.6 million). The Ministers voiced their concern that delays in diagnosis and limited access to treatment can have catastrophic consequences for the poor. "High blood pressure is a strong and reliable warning signal that health is at risk and that something needs to be done. But it often shows no symptoms for years and by the time symptoms appear, cardiovascular disease is advanced and the risk of heart attack or a stroke is increased" said WHO Director General, Dr Margaret Chan. "The public health challenge is to get more people routinely tested early to enable proper management of high blood pressure through life style change or medication" she added. India's Minister for Health and Family Welfare Mr Ghulam Nabi Azad highlighted that India is soon to be certified as a polio free country. He acknowledged WHO undivided support to the Government's strong political will and leadership at the highest levels. "India is called the "pharmacy of the world" for producing high quality and affordable generic drugs which have substantially brought down the prices" he said. "India also has several institutions that excel in public health and are open to neighboring countries in the area of capacity building aimed at increasing skilled human resources in health" "We have developed indigenous vaccines and testing reagents for H1N1 and other influenzas; indigenous vaccine for Japanese Encephalitis and a magnifying device for cervical cancer screening in the field" he added. Through the New Delhi Declaration, ministers committed to: ·Multisectorial collaboration with key stakeholders and to empower people to make healthy choices for healthy lives;·Develop multisectoral policies to promote physical activity and healthy diet and reduce exposure to tobacco and harmful use of alcohol;·Implement national salt reduction strategies, regulate the food industry including food labelling, and reduction of salt in processed foods;·Legislate for 100% tobacco smoke-free settings;·Promote universal access to prevention, treatment and care for the integrated management of noncommunicable diseases including hypertension, through a primary health care approach. From 11 to 13 September, delegations from 11 South-East Asian countries will meet at WHO's Regional Office for the Sixty-sixth Session of the WHO Regional Committee ]]> <![CDATA[Delhi hosts health ministers of South East Asia, NCDs on top priority ]]> https://biospectrumindia.com/news/95/4660/delhi-hosts-health-ministers-of-south-east-asia-ncds-on-top-priority-.html https://biospectrumindia.com/news/95/4660/delhi-hosts-health-ministers-of-south-east-asia-ncds-on-top-priority-.html Mon, 09 Sep 2013 16:20:00 +0530 The health ministers from elevan countries of World Health Organization's (WHO) South-East Asia Region will meet in New Delhi from September 10 to 13 to discuss key health issues facing the Region. The 31st meeting of health ministers of the region will be held on September 10. The meeting, a forum for exchange of national experiences on the political, social and economic dimensions of health, is being hosted by union health minister Ghulam Nabi Azad. This will be followed by the 66th session of the WHO Regional Committee for South-East Asia. The Regional Committee is a statutory body comprising the member countries and meets once a year to review progress and regional implications of the World Health Assembly decisions and to map the way forward. Dr Margaret Chan, WHO director-general, and Dr Samlee Plianbangchang, WHO regional director for South-East Asia, will be present with their team of senior advisers at both meetings. The meeting of ministers will discuss ways to address this leading risk factor for mortality in the Region. The ministers are expected to adopt the 'New Delhi Declaration on High Blood Pressure'. The Regional Committee Meeting will include discussion on key technical issues, including Universal Health Coverage (UHC). The goal of universal health coverage is to ensure that all people obtain the health services they need without suffering financial hardship when paying for them. Evidence indicates that two areas cause significant inequities and inefficiencies in health in the Region: first, direct out-of-pocket payments for access to care that can push households into poverty; and, second, a significant proportion of these payments go towards the purchase of medicines. Accordingly, the WHO Regional Strategy for Universal Health Coverage recommends that countries strengthen their health systems based on the primary health care approach - focusing on public health including prevention and promotion activities; using appropriate technologies; and based on domestic resources as far as possible. Another key area of discussion will be targets for prevention and control of non-communicable diseases (NCDs). NCDs are the leading cause of mortality globally and in the region. Each year around 7.9 million people die due to NCDs accounting for 55 per cent of all deaths in the Region. Measles elimination and rubella control will be another agenda for discussion. Measles remains a significant cause of morbidity and mortality in the Region accounting for about half the estimated global measles deaths in 2011. The countries of the Region are expected to set a measles elimination target at the meeting. Most countries of the Region have already reduced measles deaths by 70 per cent by stepping up routine immunization coverage enhanced by supplementary campaigns. ]]> <![CDATA[WHO: NCDs biggest killer in South East Asia]]> https://biospectrumindia.com/news/95/7010/who-ncds-biggest-killer-in-south-east-asia.html https://biospectrumindia.com/news/95/7010/who-ncds-biggest-killer-in-south-east-asia.html Fri, 06 Sep 2013 16:31:00 +0530 An estimated 7.9 million lives, 55% of all deaths in the South-East Asian region, are lost every year due to noncommunicable diseases (NCDs) making it the biggest killer in WHO's South-East Asia Region. Four major NCDs - cardiovascular diseases, chronic respiratory diseases, cancers and diabetes together kill the largest number of people in the region. These NCDs share four behavioral risk factors: tobacco use, unhealthy diet, physical inactivity and harmful use of alcohol. Therefore, eleven countries from the region including Bangladesh, Bhutan, South Korea, India, Indonesia, Maldives, Myanmar, Nepal, Sri Lanka, Thailand and Timor-Leste, are expected to adopt 10 targets to prevent and control noncommunicable diseases by 2025. The Health Ministers will meet at the Sixty-sixth Session of the WHO Regional Committee for South-East Asia in New Delhi on September 10 to 13 to discuss key health issues. The increase in NCDs is attributed to factors such as population ageing, rapid and unplanned urbanization, negative effects of globalization (such as trade and irresponsible marketing of unhealthy products), low literacy, and poverty. "Noncommunicable diseases exact a huge toll on national economies. NCDs disproportionately affect poor, impoverished families and are a growing burden on health systems," said Dr Samlee Plianbangchang, WHO Regional Director for South-East Asia. "These 10 targets are ambitious goals and they demonstrate that governments are serious about reducing the disease burden from NCDs" he added. The macroeconomic impact of NCDs is profound, resulting in loss of productivity and gross domestic product. Due to long-term treatment costs and high out-of-pocket costs, NCDs can result in catastrophic health expenditures and impoverishment. In India, for example, the share of out-of-pocket expenditure due to NCDs increased from 32% in 1995 to 47% in 2004; of this NCD-related expenditure, 40% was financed by household borrowing and sale of assets. In Thailand, the economic burden of the harmful use of alcohol was estimated to be equivalent to 2% of the gross domestic product in 2006. According to a recent analysis by Harvard School of Public Health, the cumulative economic loss due to the four major NCDs in India for 2012 - 2030 is estimated as 3.9 trillion dollars. The United Nations General Assembly galvanized global momentum and commitment to address NCDs at a high-level meeting in 2011. In May 2013 the World Health Assembly unanimously adopted a resolution endorsing the Global Action Plan for Prevention and Control of NCDs. The global action plan covers the period 2013-2020. The Assembly also adopted the global monitoring framework and a set of nine voluntary global targets. At the WHO Regional Committee Meeting, countries of the South-East Asian Region are expected to endorse all nine global targets. The Region is also endorsing a tenth target to address household air pollution which remains a neglected issue especially affecting poor rural women. The target calls for a 50% reduction in households using solid fuels like wood, crop residue, dried dung, coal and charcoal, as the primary cooking source. Household air pollution (HAP), also known as indoor air pollution is a major contributor to death due to lower respiratory tract infections in children and chronic obstructive pulmonary disease in adults. Other adverse effects of HAP include tuberculosis, cataracts, cerebrovascular diseases and poor maternal outcomes including stillbirth. An estimated 3.5 million deaths in 2010 were attributed to household air pollution globally. According to WHO estimates, while 50% of the global population uses solid fuels for their energy needs, 61% of households in the Region use solid fuels, which is second only to Africa at 77%. Household air pollution is largely a problem of poverty and lack of access to clean fuels. Therefore it requires committed actions by multiple sectors including the governments, industry, NGOs and the private sector. The Regional Committee is expected to adopt a Regional Action Plan for Prevention and Control of NCDs. The action plan is intended to provide a roadmap of actions for developing and implementing policies and programmes to reduce the burden of NCDs. It also provides a roadmap to achieve a 25% reduction in deaths from cardiovascular diseases, cancers, diabetes, or chronic respiratory diseases by 2025. Implementation of the plan will be monitored through a set of indicators which are consistent with the global monitoring framework. Reports on progress in implementing the action plan will be submitted to the WHO Regional Committee sessions in 2016, 2018 and 2021. 10 Targets to be achieved by 2025 1)25% relative reduction in overall mortality from cardiovascular diseases, cancers, diabetes, or chronic respiratory diseases.2)10% relative reduction in the harmful use of alcohol.3)30% relative reduction in prevalence of current tobacco use in persons aged over 15 years.4)10% relative reduction in prevalence of insufficient physical activity.5)30% relative reduction in mean population intake of salt/sodium.6)25% reduction in prevalence of raised blood pressure.7)Halting the rise in obesity and diabetes.8)50% of eligible people receive drug therapy and counselling (including glycaemic control) to prevent heart attacks and strokes.9)80% availability of affordable basic technologies and essential medicines, including generics, required to treat major NCDs in both public and private facilities.10)50% relative reduction in the proportion of households using solid fuels as the primary cooking source. ]]> <![CDATA[PD Hinduja Hospital Launches Short Stay Services]]> https://biospectrumindia.com/news/95/3408/pd-hinduja-hospital-launches-short-stay-services.html https://biospectrumindia.com/news/95/3408/pd-hinduja-hospital-launches-short-stay-services.html Fri, 06 Sep 2013 15:44:43 +0530 Mumbai's PD Hinduja Hospital inaugurated a dedicated Short Stay service wing. Widely known as 'Day surgery,' Short Stay Service (SSS) invovles admitting patients for a planned surgical procedure and releasing them the same day. Advancement in surgical technology and anaesthetic techniques is making treatment faster and less intrusive for patients. At the vanguard of technological upgradations and regular skills updation though participation in international academic programmes. SSS wing offers 19 beds, with four of these beds in the premium category. Housed in the tertiary hospital, SSS patients will have access to quality care through state-of-the-art operation theatres, labs and qualified doctors. Designed with the comfort and convenience of patients as its guiding principle, billing, nursing, attendants waiting area and doctor's rooms are located on the same floor. The operation theatres are only one floor away and diagnostics wing is two floors awa. A team of customer service personnel will be on hand at all times, to guide patients right from admissions to check out, and keep tracks of patients recovery even after discharge. A high nurse to bed ratio ensures personalised service for all patients. Benefits to patients: - Lower costs due to reduced length of stay. - Insurance companies are increasingly accepting short stay procedures. -Access to state-of-the-art operation theatres, labs and highly qualified doctors. - Reduced length of stay ensures a speedier return to work and community. - Home care service is also available to patients after their discharge. - Post discharge patient can reach doctor for any complications with the help of emergency number. ]]> <![CDATA[Assam in PPP Model with HealthFore Technologies ]]> https://biospectrumindia.com/news/95/3406/assam-in-ppp-model-with-healthfore-technologies-.html https://biospectrumindia.com/news/95/3406/assam-in-ppp-model-with-healthfore-technologies-.html Fri, 06 Sep 2013 13:09:00 +0530 The National Rural Health Mission (NRHM), Assam together with the Department of Health and Family Welfare, Government of Assam launched first of its kind Tele Radiology project in a public private partnership model with Healthfore Technologies limited. The project was inaugurated by Shri Ghulam Nabi Azad, Honourable Union minister of Health and Family Welfare in the presence of Shri Tarun Gogoi, Honourable Chief Minister, Assam, Dr Himanta Biswa Sarma, Honourable Minister of Health and Family Welfare, Assam and Smt. Anuradha Gupta, Additional Secretary and Mission Director, NRHM. Mr. Pankaj Vaish, CEO represented healthFore Technologies. In the first phase, this program is beginning its roll out in 11 districts in Asam, namely, Guwahati, Mangladai, Lakhimpur, Hailakandi, Nagaon, Kokrajhar, Dhubri, Haflong, Jorhat, Barpeta and Silchar ]]> <![CDATA[Rockland Hospital Launches its Cardiac Department]]> https://biospectrumindia.com/news/95/3405/rockland-hospital-launches-its-cardiac-department.html https://biospectrumindia.com/news/95/3405/rockland-hospital-launches-its-cardiac-department.html Fri, 06 Sep 2013 12:55:58 +0530 The addition of a full fledged Cardio department by the Rockland Hospitals group in its Qutab institutional area. The facility is yet another step in upgrading the facilities at its oldest unit in line with the group's newly created hospitals at Manesar and Dwarka, which have been built to international standards. Rajesh Srivastava, Chairman, Rockland Hospitals, said that "the foreign exchange earning potential in this sector is very high. India is already a leading nation in Asia and can become the No 1 destination in Asia on the strength of its quality doctors and upcomig world class infrastructure. The healthcare sector also offers a huge opportunity for the young Indians to be globally employed as the Indian doctors and nurses are already internationally respected for their competence." Mrs Preneet Kaur, Minister of State and External Affairs, New Delhi, inaugurated the Cardiac Department at the Rockland hospital, Qutab institutional area, Southern Delhi. She highlighted the impotance of diagnostics at remote locations through technology interface and a need for quality healthcare delivery up to village levels at affordable costs. ]]> <![CDATA[Ranbaxy completes 20 years in Russia]]> https://biospectrumindia.com/news/95/2987/ranbaxy-completes-20-years-in-russia.html https://biospectrumindia.com/news/95/2987/ranbaxy-completes-20-years-in-russia.html Thu, 05 Sep 2013 17:43:24 +0530 India's largest pharmaceutical company, Ranbaxy Laboratories Ltd (Ranbaxy) announced that the company has completed 20 successful years in Russia. The Russian pharmaceutical market is estimated at around US $20 billion (IMS MAy 2013) growing at a CAGR of around 11% On the successful completion of 20 years, Mr. HeArun Sawhney, CEO and MD, Ranbaxy said, "Ranbaxy was one of the first pharmaceutical companies from India to set up operations in Russia. We have been providing high quality, affordable generic medicines to the citizens of Russia for the last two decades, there by supporting the government to bring down healthcare costs. We remain committed to the Russian market and will continue to operate from the paradigm of quality and patients first." With a well-established distribution network and skilled field force, ranbaxy today has operations in 56 regions in Russia and has built strong equity with its customers. The company has a portfolio of products covering anti-infective, cold, pain management, cardiovascular, diabetology, central nervous sysytem, urology and dermatology segments. So far, the company has registered 51 drugs in the Russian Federation commercialised 72 SKU's. Ranbaxy's leading brands in Russia includes Ketanov, Coldact, Faringosept, Cifran, Pylobact and Fenules. Last year, the company's popular brand, Faringosept was selected as the people's brand of choice. Aman Khanna, Country Head of Russia, commented "Over the year Ranbaxy has established itself a preferred generic pharmaceutical company in Russia. In the coming years, we look at further expanding our product portfolio to include value added and innovator products from our parent company, Daiichi Sankyo. We are working closely in partnership with regional Governments in Line with the Russia Pharma, 2020 Healthcare Plan." Earlier in 2011, Ranbaxy and the government of Yaroslavl signed a Memorandum of Understanding for cooperation in the field of healthcare and medical science, which was a major milestone. As part of the program, most clinical pharmacologists and senior medical students of Yaroslavl region have been trained in Pharmacovigilance. ]]> <![CDATA[UKTI signs life sciences MoU with ABLE]]> https://biospectrumindia.com/news/95/3407/ukti-signs-life-sciences-mou-with-able.html https://biospectrumindia.com/news/95/3407/ukti-signs-life-sciences-mou-with-able.html Thu, 05 Sep 2013 16:10:00 +0530 UK Trade & Investment (UKTI) and the Association of Biotech Led Enterprise (ABLE) recently signed a memorandum of understanding (MoU) to encourage and develop collaboration between Indian life sciences organizations and the United Kingdom, in Bangalore. The 12-member UK delegation comprised prominent members from universities, healthcare companies, cancer research organisations and healthcare providers such as diagnostics and drug delivery systems. British deputy high commissioner Ian Felton said, "Oncology is a key area of concern in the UK and in India. This mission is to firm up relations on some extremely innovative work in the area of oncology. UK-India joint innovation in the discovery and delivery of oncology will help to make this element of healthcare accessible and affordable to patients in both countries." Dr PM Murali, president, ABLE said, "ABLE is pleased to be signing an MOU with UKTI for collaborating on a range of opportunities. Cancer represents one of the most challenging disease areas that require researchers and clinicians to work together at a global level. We recognize the importance of this delegation and appreciate its purpose." The MoU will aim at combining UK's heritage and leadership in the area of healthcare and life sciences and India's emerging and thriving healthcare ecosystem to promote and develop the life sciences sector in both countries. The delegation also participated in two roundtable discussions with other industry experts. The focus of the first roundtable was discovery research in cancer, IP and its effects, opportunities for licensing to Indian companies, diagnostics research and new biomarkers. The second roundtable focused on healthcare aspects such as medical technology companies, access to large hospitals and distributors in India. ]]> <![CDATA[Cabinet okays Mylan's proposed takeover of Agila ]]> https://biospectrumindia.com/news/95/3393/cabinet-okays-mylans-proposed-takeover-of-agila-.html https://biospectrumindia.com/news/95/3393/cabinet-okays-mylans-proposed-takeover-of-agila-.html Wed, 04 Sep 2013 14:34:59 +0530 The Cabinet Committee on Economic Affairs on September 03, 2013, gave its approval to the proposal of Mylan Inc., USA, as recommended by the Foreign Investment Promotion Board (FIPB) to acquire 100 percent of the fully paid up share capital of Agila Specialities Private Limited. The approval would result in foreign investment amounting to Rs 5,168 crore approximately in the country. Mylan Inc., USA (Mylan), a fully integrated global pharmaceutical company, was incorporated on August 31, 1970. Along with its subsidiaries, it develops licenses, manufactures, market and distributes generic, branded and specialty pharmaceuticals. It is a publicly held Corporation, listed on the NASDAQ. Mylan has a presence in India through its subsidiaries, Myland Laboratories Limited, Mylan Pharmaceuticals Private Limited and Astrix Laboratories Limited. ]]> <![CDATA[Nominations for Breakthrough Prizes in life sciences now open online]]> https://biospectrumindia.com/news/95/6277/nominations-for-breakthrough-prizes-in-life-sciences-now-open-online.html https://biospectrumindia.com/news/95/6277/nominations-for-breakthrough-prizes-in-life-sciences-now-open-online.html Wed, 04 Sep 2013 14:06:00 +0530 The Breakthrough Prize in Life Sciences Foundation recently announced the opening of online nominations for Breakthrough Prizes for 2014. The rules and nomination form are made available in their official site. As per the rules, anyone can nominate a candidate online and all submissions must be completed by a third party. Nominations will be accepted through October 2, 2013. This year the foundation will award up to five prizes worth $3 million each, sponsored by Sergey Brin and Anne Wojcicki, Mark Zuckerberg and Priscilla Chan, and Yuri Milner. All prizes will be awarded for research aimed at curing deadly diseases and extending human life, with special attention to recent discoveries. One prize sponsored by Sergey Brin and Anne Wojcicki is aimed specifically at advancements in Parkinson's disease research. The 2014 prize winners will be chosen by the foundation's selection committee, comprised of prior recipients of the Breakthrough Prize in life sciences, including, Cornelia I. Bargmann, David Botstein, Lewis C. Cantley, Hans Clevers, Napoleone Ferrara, Titia de Lange, Eric S. Lander, Charles L. Sawyers, Bert Vogelstein, Robert A. Weinberg, and Shinya Yamanaka. "We all benefit from the brilliance and commitment of researchers at the frontiers of medical science. This is a chance to reward their achievements and support their future work. If you think someone deserves a Breakthrough Prize, you have the power to put them in the running," said Mr Art Levinson, Chairman of Apple Inc., Genentech, and The Breakthrough Prize in Life Sciences foundation. The Breakthrough Prize in Life Sciences Foundation is a non-profit organization created by Art Levinson, Sergey Brin and Anne Wojcicki, Mark Zuckerberg and Priscilla Chan, and Yuri Milner. ]]> <![CDATA[DBT to promote biotech tools to ensure safe food ]]> https://biospectrumindia.com/news/95/3402/dbt-to-promote-biotech-tools-to-ensure-safe-food-.html https://biospectrumindia.com/news/95/3402/dbt-to-promote-biotech-tools-to-ensure-safe-food-.html Tue, 03 Sep 2013 15:10:00 +0530 The need for a wholesome, quality, pathogenic free stable food is critical in food security. As food safety issues are gaining importance, there is a need to provide greater assurance about the safety and quality of foods. Taking this into account, public health, food and nutrition division of the department of biotechnology (DBT), ministry of science and technology, government of India, has asked for research and development proposals in the various identified thrust areas. These include the development of diagnostic tests for detection of food borne pathogens/toxins/toxic agents. The idea is to develop sensitive, newer, cost effective and simple methodologies/tests/kits to quantify the potential toxic agents in food, feed and water e.g., food contaminants, microbial pathogens including mycotoxins, adulterants and newer food additives. Apart from that the toxicological evaluation and risk assessment and management: Toxicity/allergenicity/safety data for biological/chemical contaminants, adulterants and traditionally used herbs as food additives. Proposals may be submitted by scientists/ interdisciplinary groups working in recognised R & D Institutions. The screening of proposals will be undertaken by constituted expert committee for consideration of financial support by DBT. Last Date of submission of proposals has been kept as October 31, 2013. The food with its nutrients, apart from being consumed by human, could also act as a medium for the growth of spoilage and pathogenic microorganisms. A number of factors contribute to food being unsafe and causing foodborne illness. e.g. Intrinsic factors inherent to the food (e.g., pH, water activity and nutrients) and extrinsic factors external to it (e.g., temperature, gaseous environment and competitive microflora). ]]> <![CDATA[Avesthagen Nutrition Unit takes bite out of global pie for DHA ]]> https://biospectrumindia.com/news/95/3304/avesthagen-nutrition-unit-takes-bite-out-of-global-pie-for-dha-.html https://biospectrumindia.com/news/95/3304/avesthagen-nutrition-unit-takes-bite-out-of-global-pie-for-dha-.html Mon, 02 Sep 2013 17:44:07 +0530 Avesthagen Limited, India's leading integrated systems biology platform company announces License Agreement with one of the world's leading specialty chemicals companies for its 100% vegetarian AvestaDHATM for animal feed application. DHA is naturally found in different types of fish oils and marine planktons, but it is anticipated that the supply from this source will be insufficient to meet the growing demands. As per the industry analysts, just the algal DHA/EPA market for 2013 is expected to exceed $525 million while growing at an annual rate of 24%. Dr Villo Morawala Patell, founder and Chairperson Avesthagen said, "This is one step towards our rigorous commitment to discovery and commercialisation of science based products that promote health and well-being through out life. AvestaDHATM will serve as an acceptable and safe source of DHA for the much neglected filed of animal health." Avesthagen's innovative patented and trademarked technology allows commercial production of superior quality, 100% vegetarian AvestaDHATM derived from microalgae found in the Indian Ocean. Furthermore Dr. Patell adds, "Avesthagen is open for global licensing, manufacturing and marketing alliances for human and medical nutrition, animal feed and many other applications. AvestaDHATM is targeted at improving the nutritional health of the bottom of the pyramid and Avesthagen invites like-minded government, private organisations and civil society to join in the mission." Avesthagen developed AvestaDHATM with a grant from CSIR under the New Millennium Technology Leadership (NMITLI) scheme for production of cost effective and renewable sources of DHA and other Long Chain Polysaturated Fatty Acids. The project also involved the National Institue of Oceanography. the Indian Institute of Integrative Medicine, Jammu. and the Indian Institue of Chemical Technology, Hyderabad. The agreement is non-exclusive and Avesthagen stands to earn USD30 millions over the next decade. ]]> <![CDATA[India pharma receives highest FDI worth $1 billion]]> https://biospectrumindia.com/news/95/3309/india-pharma-receives-highest-fdi-worth-1-billion.html https://biospectrumindia.com/news/95/3309/india-pharma-receives-highest-fdi-worth-1-billion.html Mon, 02 Sep 2013 17:35:00 +0530 The Indian pharmaceutical industry has received US $1 billion as FDI (Foreign Direct Investment) - the highest among top 10 segments, during April-June this year. Back in April-June 2012, the Foreign Direct Investment (FDI) in the drugs and pharmaceutical industry was at $465 million, according to the latest data of Department of Industrial Policy and Promotion (DIPP) Between April 2000 and June 2013, India has attracted FDI worth USD 11.31 billion, which is 6 per cent of the total foreign inflows. The Finance Ministry has recently cleared US-based pharmaceutical firm Mylan Inc's proposal worth Rs 5,168 crore, to acquire Indian generic drugs company Agila Specialties. Other big acquisitions include Shantha Biotechnics by Sanofi-Aventis, a French pharma company. In 2008, Japanese firm Daiichi Sankyo bought India's largest drug maker Ranbaxy for USD 4.6 billion. The other nine sectors which received FDI during April-June quarter of the fiscal include services (USD 945 million), automobile industry (USD 515 million), computer software and hardware (USD 171 million) and construction development (USD 167 million). During the first quarter of the fiscal, the country attracted highest FDI from Singapore (USD 1.85 billion), followed by Mauritius (USD 1.09 billion), Germany (USD 510 million) and the Netherlands (USD 408 million). ]]> <![CDATA[Long ignored, disease prone North East catches govt attention ]]> https://biospectrumindia.com/news/95/3310/long-ignored-disease-prone-north-east-catches-govt-attention-.html https://biospectrumindia.com/news/95/3310/long-ignored-disease-prone-north-east-catches-govt-attention-.html Mon, 02 Sep 2013 16:50:00 +0530 The people of North-East been facing challenge posed by lung fluke, a disease that is clinically confused with tuberculosis due to its signs and symptoms. These peculiar problems have been attributed to the its geography and long international borders with several countries which make human population vulnerable to transmission of many communicable diseases like influenza and vector borne diseases. Recent data from the Indian Council for Medical Research's (ICMR) National Cancer Registry Programme has been an eye opener showing a very high prevalence of mouth (hypopharynx) and upper gastrointestinal tract (oesophagus) cancer, which is several times higher when compared with other parts of country. For example, oesophagus cancer in East Khasi Hills is 14 fold higher than that in Delhi and 5 fold higher than that in Dibrugarh in Assam. This problem of clustering of cancers in East Khasi Hills of Meghalaya, Mizoram, and Kamrup district of Assam deserves special attention and research programmes are being planned to understand the specific causes to mount an effective response. Speaking on the sidelines of an event on biotechnology at Guwahati, the health minister of India mentioned that now government is seriously looking at mitigating few of these issues on priority basis. "The problem of meningitis outbreaks and increase in number of adult cases of Japanese Encephalitis in some districts of Assam has caught our attention." Azad elaborated that ICMR is taking steps to set up advanced centres in different states of North East which will be coordinated by its Regional Institute at Dibrugarh. A multi-disciplinary research unit has been established in Assam Medical College, Dibrugarh. Laboratories have been approved for Guwahati, Assam and Agartala, Tripura and planning for establishing ICMR Centres at Meghalaya, Mizoram, Nagaland, Sikkim and Arunachal Pradesh is at an advanced stage." The minister added further, "The health ministry will do its utmost to ensure coordination with DBT, DST, DRDO and other science departments to get the maximum benefits from improving the medical and life-sciences research scenario and its consequent impact on medical education and patient care in Assam and other North Eastern states." ]]> <![CDATA[Govt been supportive of biotech industry: Azad]]> https://biospectrumindia.com/news/95/3401/govt-been-supportive-of-biotech-industry-azad.html https://biospectrumindia.com/news/95/3401/govt-been-supportive-of-biotech-industry-azad.html Mon, 02 Sep 2013 15:47:00 +0530 A national symposium on "Development and Nurturing of Emerging Interface between Medical Science and Biotechnology" was held in Gauhati University today on September 2, 2013. The seminar was inaugurated by Ghulam Nabi Azad, union minister of health and family welfare. Addressing the inaugural session, Azad said the history of biotechnology is several centuries' old, beginning with identification of organisms for production of cheese and bread, different kinds of alcohols, enzymes and many antibiotics over the years. Development of hybrid animals and plants for producing better varieties for milk or meat production are the examples of utilization of genetic re-combinations for commercial purposes. During recent years translational research has emerged as an important area for healthcare in general and the biotechnology and the pharmaceutical industries in particular. Over the years, biotechnology has become much more refined since we are now able to operate at the gene level. In case of healthcare applications, science has now moved from genetics in which selected genes were targeted and studied to genomics in which the structure and function of the genes of a particular species can be studied simultaneously by using DNA chips. Molecular methods are proving to be very useful in diagnosis and tracking. A recent example has been the effective tracking of sources and control of polio by the Entero-virus Research Centre of ICMR, Mumbai. Azad said government has been supportive, resulting in the rapid strides in biotechnology and medical products in the country. Sensing the need to nurture cutting edge research, the government of India created a Department of Biotechnology two decades ago. Today, substantial financial support is being extended not only through Department of Biotechnology, but many other central agencies such as Department of Science and Technology (DST), Council for Scientific and Industrial Research (CSIR), Indian Council of Agricultural Research (ICAR), Defence Research Development Organization (DRDO), Ministry of Environment and Forests and Indian Council of Medical Research under the Department of Health Research of Health Ministry. These agencies are not only nurturing the interface between our national requirements and the biological sciences but also spurring innovations by making intense efforts on translational and implementation research. The process has received a greater impetus during the last three years with dedicated infrastructure to identify and translate leads into products, processes and technologies for improving the healthcare delivery services. ]]> <![CDATA[PATH rejects standing commitee's report on cervical cancer project ]]> https://biospectrumindia.com/news/95/1386/path-rejects-standing-commitees-report-on-cervical-cancer-project-.html https://biospectrumindia.com/news/95/1386/path-rejects-standing-commitees-report-on-cervical-cancer-project-.html Mon, 02 Sep 2013 11:59:00 +0530 The Indian Parliament's Standing Committee on Health and Family Welfare on August 30, 2013, released a report critical of a cervical cancer vaccine demonstration project conducted in India from 2009 to 2010 through a collaboration among PATH (an international nonprofit organization), the Indian Council of Medical Research (ICMR), and the state governments of Andhra Pradesh and Gujarat. The demonstration project in India was part of a four-country project to explore suitable vaccine delivery strategies and help provide evidence for national health authorities to make informed decisions about the potential benefits and challenges of introducing vaccines against human papillomavirus (HPV), the primary cause of cervical cancer. These projects in India, Peru, Uganda, and Vietnam generated important new evidence on the best ways to introduce HPV vaccines and are informing the work of governments across Africa, Asia, and Latin America to help prevent cervical cancer deaths. The results paved the way for Peru and Uganda to launch national immunization programs against HPV and contributed to the GAVI Alliance's decision to subsidize HPV vaccines for the world's poorest countries. Responding to the report, PATH issued a statement that welcomeed public discussion about the role of vaccines in preventing life-threatening diseases such as cervical cancer but also rejected the unneccessary crticism of the vaccine project. It mentioned, "We thank the committee members for their time and effort in reviewing this matter. We support the adoption of reasonable measures to further strengthen and clarify protections for individuals participating in research projects. However, we are troubled by the report's inaccurate characterization of this important work." Cervical cancer is a preventable disease, yet it kills 275,000 women every year, nearly all of them in low-resource countries. India bears one-quarter of the world's burden of cervical cancer, which kills an estimated 72,825 Indian women annually. The ICMR, India's highest medical research authority, reviewed and approved the protocol for this project, including its design and methodology. At the time of its review, the ICMR determined the project was a post-licensure observational study and not a clinical trial. The project did not seek to evaluate the efficacy or long-term safety of the vaccines, which had already undergone clinical evaluation in India and had been licensed and approved by the Drugs Controller General of India. The ICMR's view was crucial, as it established the approval processes and protocols for the work that followed. PATH designed the project protocols in compliance with the ICMR's instructions and fully complied with the ICMR's requirements regarding the necessary approval processes and the requirements of state governments regarding consent processes. "We believe that by following the guidance provided by the ICMR, as well as two state governments and three ethical review committees, we designed a project that met or exceeded the country's existing regulatory standards for demonstration projects while providing the greatest health benefit to Indian women," said the report, "It is important to note that the safety of HPV vaccines had already been scientifically established through clinical trials in India and other countries before any use of the vaccines in this demonstration project. Scientific evidence continues to show that the vaccines have excellent safety profiles, with more than 100 million vaccine doses delivered and not a single death causally associated with the vaccine anywhere in the world. HPV vaccines are currently licensed and available in India and more than 120 other countries. At least 40 countries include them in their national immunization programs. The HPV vaccines used in the project had been licensed and approved by the Drugs Controller General of India before any vaccines were administered, and HPV vaccination had been recommended by the Federation of Obstetric and Gynaecological Societies of India, the World Health Organization, and the US Centers for Disease Control and Prevention, among others. HPV vaccines remain available in India today from private medical providers serving primarily wealthy families but not from the Indian public health system. An essential goal of the project was to understand the challenges of equitable introduction of HPV vaccines in routine public-sector immunization services. In support of that goal, state authorities and PATH worked together to ensure an economically diverse group of project participants, including urban, rural, and tribal populations. Specific districts and blocks within those districts were selected in consultation with state officials, the ICMR, and state-level project advisory groups, to ensure that project participants were representative of all segments of society. HPV vaccines were then made available to 10- to 14-year-old girls in the project sites, regardless of their social, economic, ethnic, or religious status, if their parents or guardians provided written, informed consent and if the girls provided verbal assent. India bears a disproportionate share of the burden of cervical cancer deaths, and girls in low-income areas are least likely to have access to the vaccines that could save their lives. It is both scientifically sound and morally imperative to include underserved populations in our work to improve health in India and around the globe. For adult women, who would not benefit from the vaccine, PATH also worked to strengthen screening programs in the project areas. ]]> <![CDATA[Delhi student bags top honours at International BioCamp]]> https://biospectrumindia.com/news/95/7121/delhi-student-bags-top-honours-at-international-biocamp.html https://biospectrumindia.com/news/95/7121/delhi-student-bags-top-honours-at-international-biocamp.html Fri, 30 Aug 2013 17:04:02 +0530 Nehul Saxena, currently pursuing her doctoral studies at the International Centre for Genetic Engineering and Biotechnology (ICGEB), New Delhi was selected among the top three students at the Novartis International Biotechnology Leadership Camp (BioCamp) that recently concluded in Basel, Switzerland. Apart from her the other two toppers were from England and Switzerland. Students were evaluated by a jury on their contribution, performance and teamwork. "Novartis BioCamp offers young talent the opportunity to interact with leading scientists and to look at entrepreneurship as an option," explained Ranjit Shahani, Vice Chairman and Managing Director of Novartis India Limited. Also he explained "India has some very bright talent and it's truly heartening to see young woman from India win accolades at such a high level. I do believe innovation is the way forward for our country and hope that Novartis through Biocamp will draw moreyoung people to research thereby generating new ideas around scientific innovation and improving patient outcomes." Workshops and presentations were led by leading scientists and members of top management at Novartis including, among others, Rolf M Zinkernagel, MD, a Nobel Laureate and member of the Novartis AG Board of Directors, and Prof Susan Gasser, Director of the Friedrich Miescher Institute of Biomedical Research. Biocamp students interacted with Novartis scientists and executives who lead the Company's approach to drug development and learnt about new breakthrough medicines to address patients unmet medical needs. The program is designed to help students understand trends and challenges in the biotechnology and life science sectors as well gain first-hand experience about starting and running a biotech company. Biocamp is an international forum for science and business students from around the world to learn, exchange ideas and work together in highly competitive business. ]]> <![CDATA[Pharmaceutical packaging market expected to touch USD 73.04 billion by 2018]]> https://biospectrumindia.com/news/95/6171/pharmaceutical-packaging-market-expected-to-touch-usd-73-04-billion-by-2018.html https://biospectrumindia.com/news/95/6171/pharmaceutical-packaging-market-expected-to-touch-usd-73-04-billion-by-2018.html Fri, 30 Aug 2013 16:53:54 +0530 According to a new market report published by Transparency Market Research titled, "Global and U.S. Pharmaceutical Packaging (Plastic Bottles, Parental Containers, Blister, Closures, Labels and Others) Market for Manufacturing and Contract Packaging-Industry Analysis, Size, Share, Growth, Trends and Forecast, 2012-2018," the global pharmaceutical packaging market was valued at USD 50.07 billion in 2011, and is expected to be USD 73.04 billion by 2018, growing at a CAGR of 5.6% from 2012 to 2018. Development of innovative packaging that provides protection, quality, security, tamper evidence and visual appeal, to enhance consumer consumption, and reduce counterfeiting and other malpractices, is expected to boost the market. Furthermore, implementation of stringent regulations by authorized agencies such as Healthcare Compliance Packaging Council (HCPC), National Quality Forum (NQF) and Food and Drug Administration (FDA) for pharmaceutical packaging is expected to contribute to the growth of the market. However, availability and volatility in the prices of raw materials is expected to hamper this growth. A shift towards nano-enabled pharmaceutical packaging and a growing demand from developing countries such as India, Brazil and China are expected to open new opportunities for growth in this market. Plastic bottles were the largest product segment of pharmaceutical packaging accounting for over 20% of the market in 2011. However, parental containers are expected to be the fastest growing product segment due to introduction of new injected therapies on account of advancements in biotechnology. Demand for pharmaceutical packaging was highest in North America and Europe, accounting for over 60% of the market in 2011. However, Asia Pacific is expected to show the fastest growth over the forecast period on account of increasing government initiatives, growing contract manufacturing activities and aging population. The market in Asia Pacific is expected to reach USD 20.63 billion by 2018. ]]> <![CDATA[India's growing stature as a hub of social entrepreneurs]]> https://biospectrumindia.com/news/95/6112/indias-growing-stature-as-a-hub-of-social-entrepreneurs.html https://biospectrumindia.com/news/95/6112/indias-growing-stature-as-a-hub-of-social-entrepreneurs.html Fri, 30 Aug 2013 14:18:00 +0530 The SEOY India 2013 Awards has received a record number of nominations for its annual Awards ceremony which takes place in Delhi this November. The Jubilant Bhartia Foundation, which organizes the SEOY Awards India in association with the Schwab Foundation for Social Entrepreneurship, says it has received a total of 209 nominations this year from all over India, a growth of 19%, compared to 180 nominations in 2012. This is the highest number of participants since the SEOY India Awards were instituted in 2010, a fact which highlights their rising popularity and India's stature as a fast-growing hub of social entrepreneurs. "The number of nominations we receive for the SEOY India awards are going up every year and we are delighted with the response. The unprecedented number of entries this year shows that social entrepreneurs want to tell their story and showcase the work they are doing to make a difference to the lives of the underprivileged groups," says Mr. Shyam S. Bhartia, Chairman and Managing Director and Mr. Hari S. Bhartia, Co-Chairman and Managing Director - Jubilant Life Sciences and Founder Directors of Jubilant Bhartia Foundation. "We are glad to be associated with the Social Entrepreneur of the Year India Awards to recognize and celebrate the efforts of social entrepreneurs who are serving the needs of the bottom-of-the-pyramid communities by offering practical and sustainable ecosystems of change and innovative solutions to various challenges posed by the society." The 209 nominations received this year relate to a diverse range of categories, with the highest number of entries coming from education (17%) and health (14%). The nominations from the rural development sector have seen a spike, from 11% last year to 15% in 2013. Environment (12%) and technology (9%) are other prominent categories, followed by disability, homelessness and housing, clean energy and employability. About 30% of all the nominations for SEOY India 2013 Awards have been received from North India, followed by South and West India at 27% and 23%, respectively. The number of entries from East India expanded dramatically this year, from 11% in 2012 to 17% now. However, nominations from Central India comprised only 2% of the total, which hints at the regions under-served by social entrepreneurs. The winners of the SEOY India 2013 Awards would be selected by a distinguished jury comprising eminent members of the Government, civil society and corporate world. The awardees would also be invited to join the Schwab Foundation's global network and participate in various events of the World Economic Forum. The SEOY India Awards have gained a new significance because social entrepreneurship is on the rise in India. The Indian parliament has recently passed a new bill that makes it mandatory for some companies to spend 2% of profits on uplifting the poor. The law will require companies with market capitalisation of more than Rs 500 crore to spend 2 percent of their annual net profits on corporate social responsibility (CSR), such as social work or charity. The Social Entrepreneur of the Year awards celebrate leading social entrepreneurs and their ventures that design and implement innovative, practical and sustainable solutions to address poverty and the lack of basic services and resources in 'Bottom of the Pyramid' and ultra-poor communities (that is, health, education, job creation, water, clean energy and access to information and technology). Whether they set up for-profit entities, hybrid social ventures or not-for-profit organizations, the primary focus of social entrepreneurs is large-scale, transformational impact. They achieve sustainability for their ventures through a creative combination of user fees, revenue through the sale of products and services, as well as grants and key partnerships with governments, business and other sectors. ]]> <![CDATA[WHO highlights key health issues in South-East Asia]]> https://biospectrumindia.com/news/95/3397/who-highlights-key-health-issues-in-south-east-asia.html https://biospectrumindia.com/news/95/3397/who-highlights-key-health-issues-in-south-east-asia.html Fri, 30 Aug 2013 12:19:00 +0530 The thirty-first meeting of health ministers of the south east asian region will be held on September 10 at New Delhi. The health minister's meeting is a forum for exchange of national experiences on the political, social and economic dimensions of health. The meeting is being hosted by Mr Ghulam Nabi Azad, union minister for health and family welfare, government of India. This will be followed by the Sixty-sixth Session of the WHO Regional Committee for South-East Asia. The Regional Committee is a statutory body comprising the Member countries,* which meets once a year to review progress and regional implications of the World Health Assembly decisions and to map the way forward. Dr Margaret Chan, WHO Director-General, and Dr Samlee Plianbangchang, WHO Regional Director for South-East Asia, will be present with their team of senior advisers at both meetings. Some of the key technical discussions to be taken up at the two sessions are: High blood pressure and its health implications. The Meeting of Ministers of Health will discuss ways to address this leading risk factor for mortality in the Region. The ministers are expected to adopt the 'New Delhi Declaration on High Blood Pressure'. The regional committee meeting will include discussion on key technical issues, including: Universal health coverage (UHC): The goal of universal health coverage is to ensure that all people obtain the health services they need without suffering financial hardship when paying for them. Evidence indicates that two areas cause significant inequities and inefficiencies in health in the Region: first, direct out-of-pocket payments for access to care that can push households into poverty; and, second, a significant proportion of these payments go towards the purchase of medicines. Accordingly, the WHO Regional Strategy for Universal Health Coverage recommends that countries strengthen their health systems based on the primary health care approach - focusing on public health including prevention and promotion activities; using appropriate technologies; and based on domestic resources as far as possible. Targets for prevention and control of noncommunicable diseases (NCDs): NCDs are the leading cause of mortality globally and in the Region. Each year around 7.9 million people die due to NCDs accounting for 55% of all deaths in the Region. The Sixty-sixth World Health Assembly adopted a resolution endorsing the Global Plan of Action for Prevention and Control of NCDs for 2013 to 2020. Nine global voluntary targets were adopted to tackle the four key areas of concern - cardiovascular diseases, cancers, chronic respiratory diseases and diabetes. In addition to adopting the nine global voluntary targets, Member States of the South-East Asia Region are expected to consider reduction of household air pollution as an additional target for the Region. The Regional Committee will also deliberate on the Regional Action Plan for Prevention and Control of Noncommunicable Diseases. Measles elimination and rubella control: Measles remains a significant cause of morbidity and mortality in the Region accounting for about half the estimated global measles deaths in 2011. The countries of the Region are expected to set a measles elimination target at the meeting. Most countries of the Region have already reduced measles deaths by 70% by stepping up routine immunization coverage enhanced by supplementary campaigns. ]]> <![CDATA[Indigenous options available for AIDS diagnosis]]> https://biospectrumindia.com/news/95/1251/indigenous-options-available-for-aids-diagnosis.html https://biospectrumindia.com/news/95/1251/indigenous-options-available-for-aids-diagnosis.html Fri, 30 Aug 2013 11:59:00 +0530 The kits for Acquired Immunodeficiency Syndrome (AIDS) have been developed indigenously by the Indian scientists in rapid and ELISA formats which are currently being manufactured and made available commercially by various companies viz., J. Mitra & Co, New Delhi; Span Diagnostics, Surat; Bhatt Biotech India, Bangalore and Qualpro Diagnostics, Goa. Talking about the home made cheap alternatives, the union minister of science and technology and earth sciences, S.Jaipal Reddy recently stated in the Parliament, "The indigenous kits are currently available in the price range of Rs. 7.50 to Rs 45 per test as compared to the foreign kits which are available in the price range of Rs 15 to Rs 65 per test." As per HIV estimation 2012, the total estimated number of people living with HIV in 2011 in India was 20,88642 (close to 21 lakh people). The Gross Budgetary Support (GBS) will be Rs 11394/ crore in the 12th Plan. Approximately Rs 7314.46 crore is allocated to be spent on HIV prevention and awareness during 12th Plan period. ]]> <![CDATA[Novel Therapies for Multiple Sclerosis available but not affordable]]> https://biospectrumindia.com/news/95/7230/novel-therapies-for-multiple-sclerosis-available-but-not-affordable.html https://biospectrumindia.com/news/95/7230/novel-therapies-for-multiple-sclerosis-available-but-not-affordable.html Thu, 29 Aug 2013 17:46:57 +0530 In recent times, a wide range of innovative therapies have become available for patients suffering from this delibating condition. These new therapies can target the differnt types of Multiple Sclerosis (MS). For example, Avonex (interferon beta la) is an injectiblein a prefilled syringe indicated for relapsing, remitting form of MS. This year, there was a new device for easier administration of Avonex called the Avonex Pen to help patients be more independent in administering therapy thus improving their adherence. Dr Joy Desai, Consultant Neurologist, Jaslok Hospital and Research Centre said, "Today, progress in drug research has made it possible to manage MS by up to 60%. Unfortunately, most patients are unable to benefit from this development as they cannot afford these therapies. Also, insurance companies have been reluctant to cover this life long diseas under medical coverage." Doctors feel that it is crucial for them to be constantly updated about the availability of new therapies. Those who were well updated about new medicines were more likely to be taking the appropriate treatments. As per Dr P P Ashok, Consultant Neurologist and Head, Division of Neurology, Hinduja Hospital "Novel treatment therapies are not uniformly accessible across the country. It is very essential for doctors and patients to have an increased awareness about the new therapies." ]]> <![CDATA[NIH suspension will not affect us claims health minister]]> https://biospectrumindia.com/news/95/3396/nih-suspension-will-not-affect-us-claims-health-minister.html https://biospectrumindia.com/news/95/3396/nih-suspension-will-not-affect-us-claims-health-minister.html Thu, 29 Aug 2013 17:15:00 +0530 In order to strengthen the regulatory provisions and the monitoring mechanism of clinical trials in the country, Drugs and Cosmetics Rules, 1945 have been amended recently. The National Institute of Health (NIH), had raised concerns about how these new requirements will be implemented, particularly the specific provision related to compensation. However, the the union minister of health and family welfare, Ghulam Nabi Azad in parliament on August 28, 2013, tried to dispel the fears. "NIH have suspended enrolment of participants in 35 international trials in India. This will, however, not affect this country's health programme and domestic pharma industry. The drug trial policy has been evolving in course of time. Government has been trying to strengthen the regulatory mechanism to ensure proper drug trials," claimed Azad. These amendments that were made during the early half of this year include: A. Amendment vide Gazette Notification G.S.R. 53 (E) dated January 30, 2013 specifying procedures to analyze the reports of Serious Adverse Events occurring during clinical trials and procedures for payment of compensation in case of trial related injury or death as per prescribed timelines. B. Amendment vide Gazette Notification G.S.R. 63(E) dated February 01, 2013, specifying various conditions for conduct of clinical trials, authority for conducting clinical trial inspections and actions in case of non-compliance. C. Amendment vide Gazette Notification G.S.R No. 72(E) dated February 08, 2013, specifying requirements and guidelines for mandatory registration of Ethics Committee. ]]> <![CDATA[India's evolving roadmap for biological attacks ]]> https://biospectrumindia.com/news/95/3392/indias-evolving-roadmap-for-biological-attacks-.html https://biospectrumindia.com/news/95/3392/indias-evolving-roadmap-for-biological-attacks-.html Thu, 29 Aug 2013 16:40:00 +0530 While health is a state subject, National Disaster Management Authority(NDMA) has published guidelines on biological disasters including bio warfare and bio terrorism in consultation with ministry of home affairs and ministry of health. The guidelines have identified the bio warfare / bio terrorism agents, characteristics of these agents, epidemiological clues to identify outbreak of disease caused by them, laboratory identification and their management including prevention and treatment. The ministry of health has a Crisis Management Plan for biological disasters that was updated last on July 24, 2013 and shared with ministry of home affairs. Workshops and trainings on biosafety and biosecurity are conducted by Indian Council of Medical Research (ICMR) at National Institute of Virology, Pune to raise awareness of biosecurity issues. Also the relevant training to prevent biosecurity incidents and raising barriers to prevent the theft of relevant materials from laboratories, is also imparted from to time. ]]> <![CDATA[College of American Pathologists (CAP) along with BD announces strategic alliance]]> https://biospectrumindia.com/news/95/4579/college-of-american-pathologists-cap-along-with-bd-announces-strategic-alliance.html https://biospectrumindia.com/news/95/4579/college-of-american-pathologists-cap-along-with-bd-announces-strategic-alliance.html Wed, 28 Aug 2013 18:06:00 +0530 With the goal to offer quality diagnosis and better treatment outcomes for pateints, CAP, the world leader in laboratory quality assurance and improvement and BD Diagnostics, a segment of BD (Becton, Dickinson and Company), a leading global medical technology company, announced the launch of a new strategic alliance that would help more pathology labs in the country to offer high quality services at par with the rest of the world. CAP President Stanley J. Robboy, MD, FCAP said "As countries around the world heighten their focus on healthcare, patients and healthcare professionals wish to achieve higher quality across the entire spectrum of care." He further added "The clinical laboratory and pathology contribute more than 70 percent of the information used to determine diagnoses and drive treatment decisions." Laboratories plays a pivotal role in the diagnosis and treatment of disease for more than a billion people in India. In unison BD and CAP will strive hard to improve awareness of global practice standards and training that will help laboratories attain their quality improvement goals. "This historic initiative brings together two of the leading global organisaations that are ideally positioned to support labortory improvement efforts around the world, particularly in India" said John Ledek, President, BD diagnostics - Preanalytical Systems. "BD has widespread reach across the sector of healthcare and laboratory testing operations, with a deepcomprehending of quality processes from both a technical and clinical perspective." added Mr. Ledek. ]]> <![CDATA[Mehta Eye Clinic Introduces LenSxÂ®]]> https://biospectrumindia.com/news/95/3377/mehta-eye-clinic-introduces-lensx.html https://biospectrumindia.com/news/95/3377/mehta-eye-clinic-introduces-lensx.html Wed, 28 Aug 2013 18:02:00 +0530 Mehta Eye Clinic Introduces LenSx®, which is a highly technologically advanced option for cataract patients and scores over traditional cataract surgery. LenSx is also known as Femtosecond Laser and is a revolutionary based technology certified by the US FDA. The technology has gained momentum across the world with over 27,000 LenSx laser cataract surgeries performed in 30 countries. Dr V C Mehta, the founder Director and Chief surgeon elaborates, "LenSx laser machines provides surgeons with real time video imaging, and 3D visualisation of the entire interior segment. This means greater surgical accuracy than before." Until now the traditional cataract surgery involved the use of manual surgical blade to open the. However LenSx will now enable surgeons to operate with matchless precision using Femtosecond laser and computer control, making it a true robotic laser cataract surgery. With in just one month of installing this technology, Mehta Eye Clinic has successfully completed over 15 LenSx laser surgeries. Dr Siddharth Mehta, the Director of the clinic, is in fact is Sx laser surgery and he adds " The future of eye care is definitely here." Dr V VC Mehta adds to it that Mehta Eye Clinic has always believed in ensuring the best care for patients by combining expertise with the best of technology. ]]> <![CDATA[Indo UK partnership on health]]> https://biospectrumindia.com/news/95/5451/indo-uk-partnership-on-health.html https://biospectrumindia.com/news/95/5451/indo-uk-partnership-on-health.html Tue, 27 Aug 2013 17:25:23 +0530 Memorandum of Understanding (MoU) has been signed between the Department of Health Research, Ministry of Health and Family Welfare, Government of India and The National Institute for Health and Care Excellence, UK on 14th June, 2013 to work together on a Strategic and technical cooperation with regard to evidence - informed healthcare policy and practice. The MoU confirms the intention of the two Parties to share their experience of the development and use of evidence to inform clinical policy and practice in the context of universal healthcare coverage. Department of Health Research and NICE will exchange institutional expertise and experiences concerning the application of Health Technology Assessment (HTA), including topic selection and prioritization of technologies for evaluation, evidence assessment and appraisal, governance and oversight arrangements and consultation processes, and the implementation of HTA - based decisions into clinical policy and practice. The initial period of validity of the MoU is for five years from the date of signing. Further, there is a provision for renewal of the MoU subject to mutual agreement. Steps have already been initiated towards the implementation of the MoU. The mechanism of implementation of the MoU includes setting up of Joint Steering Committee to translate the commitments of the MoU to a real, mutually - beneficial partnership and to steer the expertise and enthusiasm of the two countries to create better quality healthcare for the people. The collaboration is likely to benefit the Indian Health sector by bringing modern health technology to people. This information was given by the Union Minister of Health & Family Welfare Shri Ghulam Nabi Azad in written reply to a question in the Lok Sabha today. ]]> <![CDATA[Competition heats up in oncology market ]]> https://biospectrumindia.com/features/95/5200/competition-heats-up-in-oncology-market-.html https://biospectrumindia.com/features/95/5200/competition-heats-up-in-oncology-market-.html Tue, 27 Aug 2013 12:35:00 +0530 The cutthroat competition is a big concern since quite a few domestic companies and all the major multinationals have a presence in this segment in India. The depleting price realization of oncology medicines has posed a serious threat to the viability of this segment. Besides, due to low affordability and unorganised healthcare services, a large section of patients remains untapped and deprived of medical treatment, making the expandability of the market difficult. In such a scenario, neither the patient nor the manufacturer is benefiting. According to Shukrit Chimote, head, Branded Formulations-India, Biocon, "Though the average life expectancy and the cancer detection rates have steadily gone up in India over the past decade leading to increasing number of patients on cancer treatment, the Oncology market growth seems to be stagnating off late. Also, the access to quality oncology healthcare and availability of affordable medicines to large tracts of rural population remains a key challenge for the public health administrators and could be a big opportunity for exploring public-private partnerships." The market also faces regulatory hurdles, like approvals for oncology trial procedures. In addition, tight budgets act to further restrict use of new therapies in oncology. Differential pricing of expensive drugs is another challenge. Infrastructure to handle the high incidence of cancer is still very poor in India. India does not have adequate number of comprehensive cancer treatment centers and in a country where cancer incidence is increasing at rate of 2-3% CAGR it's a huge challenge. Today the country has 1 million new cancer patients according to 2011 (source: national cancer registry) and it will grow at a rate of 16% in the next 5 years. As per F&S report, India has close to 1,600 oncologists (including medical, surgical and radiation oncologists), thereby creating a huge shortage of surgical oncologists followed by medical oncologists. There are 30 RCCs (regional cancer centers) of which only 5 to 6 RCCs have adequately trained medical oncologists. Biocon's BIOMAb EGFR holds promise With several promising indications such as oesophageal cancer, cervical cancer, lung cancer, etc, Biocon is currently conducting several clinical trials at various centers in India. In collaboration with the HCG Group of Hospitals, Biocon is conducting an Investigator Initiated Trial to study the effects of Nimotuzumab in 110 cervical cancer patients. According to the company, a robust Post Marketing Surveillance study of BIOMAb EGFR® is in progress at the Tata Memorial Hospital with over 530 head & neck cancer patients. In addition, four large scale Phase III international trials (two in head and neck cancer, one in lung cancer and one in gastric cancer) are ongoing to establish Nimotuzumab's 'best-in-class' status for the treatment of various cancers. DRF works big time on cancer stem cell DRF has taken several steps to face the challenges ahead. Among the cancer stem cells, there is a growing body of evidence accumulating which suggests that cancer stem cells exist in a variety of tumors. DRF has spent last several months understanding the intricacies of working with human stem cells and is now geared up to initiate preclinical studies in this exciting new field that holds so much promise for treating cancer. Having developed its own peptide based kinase inhibitor in the past, DRF is well versed and thus currently looking at developing newer and safer drugs. Venus Remedies bets big on DPPC technology The Venus Medicine Research Centre (VMRC) has developed a target-based onco delivery model, specially for breast cancer which is in early stages of development. The 12 products in late-phase development are expected to generate sales of $2,954m by 2018. The company has up with an innovative patent-protected platform technology called Drug Protein Polymer Conjugate (DPPC) that does specific and selective targeting. ]]> <![CDATA[Bharat Biotech launches vaccine against typhoid fever ]]> https://biospectrumindia.com/news/95/4127/bharat-biotech-launches-vaccine-against-typhoid-fever-.html https://biospectrumindia.com/news/95/4127/bharat-biotech-launches-vaccine-against-typhoid-fever-.html Tue, 27 Aug 2013 12:19:22 +0530 Bharat Biotech announced the launch of world's first clinically proven typhoid conjugate vaccine Typbar-TCVTM, a fourth generation vaccine against typhoid disease on August 26, 2013. It has been proven to provide long term protection to adults and infants six months and older. The vaccine is significant because currently available Typhoid vaccines fall short in two major characteristics, namely long term protection and protection for children below twoyears of age, the population that needs it the most. During its development since 2005 Typbar-TCVTM was evaluated in ~1200 healthy subjects at nine clinical sites. In the pivotal ph III clinical study, Typbar-TCVTM presented 98% seroconversion in infants aged six months to 24 months, 99 percent in children between two to fifteen years of age, and 92 percent in the 15 to forty five year age group, as measured by four fold increase in serum IgA responses. It proved to be superior to the Vi polysaccharide typhoid vaccines. Typbar-TCVTM was also safe and well tolerated in all tested age groups. "Typhoid fever remains an important public health challenge in many countries of the world mainly because of poor diagnostics and increasing resistance to antibiotics. At present fundamental prevention strategies like improved sanitation, good hygienic practices and access to clean water are still out of reach for many impoverished communities. One of the most cost effective approaches to prevent infectious diseases, are vaccines which are available now and could help control the disease resulting in reduction of unnecessary suffering and adverse financial consequences." Dr. Christian Loucq, M.D., Director-General of the International Vaccine Institute (IVI) said. Typhoid fever is a life threatening illness caused by the bacterium Salmonella typhi, which is transmitted through food or drink contaminated by the faeces or urine of infected people. Symptoms include high fever, malaise, headache, constipation, diarrhoea, etc. Healthy carrier state may follow acute illness. It causes between 250,000 to 600,000 deaths and 20 million illnesses per year, affecting mostly school-age children. The World Health Organization reports 90 percent of typhoid deaths occur in Asia and persists mainly in children under 5 years of age. In India, Typhoid fever is observed throughout the year and a greater number of cases coincide with the rainy season. While typhoid fever can be cured by antibiotics, resistance to antimicrobials is widespread along with poor diagnostics, hence prevention of typhoid fever is better than the cure. Acknowledging the effort of his team of scientists that led to this innovation Dr. Krishna M. Ella, Chairman and Managing Director of Bharat Biotech said "Bharat Biotech's Typbar-TCVTM induces 'T' cell dependent response with much higher antibody levels providing a very high rate of immunity. We hope this vaccine will reach millions of people and help reduce the burden of this devastating disease in infants and children." Dr. Ella added. Bharat Biotech has commenced commercial production of Typbar-TCVTM in pre-filled syringes in its world class vaccine production facility in Genome Valley. The plant has capacity to produce 10 million doses each year, expandable to 50 million doses per year in the future. Bharat Biotech is the largest producer and supplier of Vi typhoid vaccine in the world having distributed over 50 million doses globally. Typbar-TCVTM is available for supplies to global markets such as South East Asia, South America, Africa, Central Asia, and South Asia. ]]> <![CDATA[Glenmark partners event on child malnutrition in India ]]> https://biospectrumindia.com/news/95/3391/glenmark-partners-event-on-child-malnutrition-in-india-.html https://biospectrumindia.com/news/95/3391/glenmark-partners-event-on-child-malnutrition-in-india-.html Mon, 26 Aug 2013 16:59:07 +0530 The Federation of Indian Chambers of Commerce and Industry (FICCI) alongwith Aditya Birla CSR Centre for Excellence and Glenmark Pharmaceuticals Ltd in a first of its kind initiative, on August 23, 2013, organized a conference titled 'Child Malnutrition: Sharing of Best Practices' at New Delhi. Aimed at understand different solutions to address issues of child malnutrition and bring out a knowledge paper on best practices in combating the malaise, the conference brought leaders from government, corporate, NGOs and relief agencies on the same platform and share their wealth of experience. Speaking at the inaugural session, Dr K K Upadhyay Head CSR at FICCI said "given that every third malnourished child lives in India and that zero to five age bracket constitutes the most vulnerable zone, corporate houses should incorporate child health in the core agenda of Corporate Social Responsibility".Upadhyay also said what is surprising is the fact that slums of Mumbai house higher number of children malnourished as compared to even the remotest areas in the country. Dr Sila Deb, Deputy Commissioner (Child Health) Ministry of Health and Family Welfare, Government of India said "the foremost weapon to fight malnourishment among children should be to convince mothers to breastfeed children from the very first hour of birth. Deb also said that severely malnourished children are 8 to 12 times more likely to die as compared to normal malnourished children and there is a clear need to build capacity of healthcare workers or ASHA to fight child morbidity and mortality. Ms Cheryl Pinto, Director Corporate Affairs, Glenmark Pharmaceuticals Ltd said, "We need to introduce innovative ways to disseminate information on right and healthy practices among rural masses. Time has now come to employ practical solutions rather than theoretical ones to ensure that our children remain healthy." She also re-affirmed Glenmark Pharmaceutical Ltd's long term commitment towards the social cause. Addressing the session titled 'Sharing from the field: Innovative models in addressing Child Malnutrition, Dr Vandana Prasad, Member National Commission for Protection of Child Rights said " In India, infant mortality is low but malnutrition is high. So, while we are managing to save children, our children are not well nourished and healthy." She emphasised on the need for social sector to focus on the need for proper nourishment of infants. ICICI Foundation chief Chinmay Sengupta said expressed concern over the problems in implementation of programmes and highlighted the hurdles in capacity building, poor data available and lack of referral within the system. Dr Alex George, Director, Action Aid India spoke about unavailability of the right products and stressed there was no need for marketisation of the public services. Malnourishment is a public issue and should not be mixed with commercial interest, he added. Dr Ashish Satav, Founder, Mahan Trust and Dr Prakash Michael of Spandan Samaj Sewa Samiti shared their experience of working at the ground level and spoke on the need to fight child malnutrition and bring positive transformation in the country. ]]> <![CDATA[Govt says free generic medicines on top priority]]> https://biospectrumindia.com/news/95/3168/govt-says-free-generic-medicines-on-top-priority.html https://biospectrumindia.com/news/95/3168/govt-says-free-generic-medicines-on-top-priority.html Mon, 26 Aug 2013 16:46:15 +0530 With the aim to provide affordable health care to the people by reducing their out of pocket expenses on medicines, an initiative for free supply of essential medicines to the patients availing treatments in public health facilities in the country has been approved in the 12th Five Year Plan to promote rational use of medicines and reduce the consumption of inessential medicines. This information was revealed by the union minister of health anf family welfare, Ghulam Nabi Azad in the parliament on August 23, 2013. "There is an outlay of Rs 16,000 crore for this initiative in the 12th Plan. The initiative is based on the Tamil Nadu model where free medicines procured in bulk by the Tamil Nadu Medical Services Corporation (TNMSC), in generic name, directly from the manufacturers is supplied through an IT enabled supply chain management system to the public," said the minister further. Azad also stated that the Central Procurement Agency has already been registered in the name of the Central Medical Services Society. He said that the modernization of health centers is the responsibility of the State / UT governments as it is a continuous and ongoing process. ]]> <![CDATA["Biologics to drive future oncology market"]]> https://biospectrumindia.com/features/95/3951/biologics-to-drive-future-oncology-market.html https://biospectrumindia.com/features/95/3951/biologics-to-drive-future-oncology-market.html Mon, 26 Aug 2013 16:30:00 +0530 According to a recent Frost & Sullivan report, the oncology market in India is presently growing at 20 percent year-on-year. It mentions that the chemotherapy, biologics, targeted therapy, hormonal therapy, and supportive care are the different types of available cancer treatment in India; among which chemotherapy recorded the highest market value of approximately Rs 700 Crore in 2012. According to the report. oncology market in India is forecasted to grow to Rs 3831 crore by 2017 at a compounded annual growth rate (CAGR) of 15.46 percent. At the same time, it also predicts a sharp rise in the market share percentage of biologics and targeted therapy, which are poised to overtake chemotherapy as the preferred treatment option. Says Dr Manu Jaggi, vice president, R&D, Dabur Research Foundation, "The Indian oncology market is forecast to grow strongly in the next decade, driven by the rise in cancer incidence and diagnosis, improved access to cancer therapies, better health insurance coverage, and higher pharmaceutical spending, particularly among the growing middle class. Since cancer is the second largest cause of death in the country, the Indian market is characterized by a huge demand for cancer drugs. It is a highly fragmented market with a large number of foreign and domestic players. The increase in government expenditure on health and improved access to cancer drugs will also drive the uptake of cancer therapeutics in the future." Due to high rates of smoking, tobacco use, occupational risks and unhygienic living conditions, Indians are at a high risk of acquiring cancer. Studies have revealed that incidence of cancer is higher amongst women than men. Cancers of oral cavity and lungs in males, and cervix and breast in females, account for over 50 percent of all cancer-related deaths in India at present. In India, there are 28 lakh prevalent cases of all types of cancer, while at least 8 lakh new cases are being witnessed every year. Ms Rekha Ranganathan, head, oncology, Philips Healthcare, is of the opinion that continued advancements in cancer research, diagnosis and treatment is aimed at controlling incidence and mortality although the rate at which it is spreading is high. "Cervix and breast cancer in females, oral cavity and lungs in male account for over 50 per cent of all cancer-related deaths in India. Only a small percentage of all cancer cases can be attributed to genetic defects, whereas the majority has their roots in the environment and lifestyle. Advancements in medical imaging from X rays, Ultrasound, robotics devices to Nuclear Medicine (Planar and SPECT Gamma Imaging, PET) for cancer detection and treatment have come a long way in improving the quality of patient's life," she adds. "The oncology pharmaceuticals market in India is the fourth largest in volume and the eighth largest in value in the global market. Since cancer is the second largest cause of death in the country, the Indian market is characterised by a huge demand for cancer drugs. It is a highly fragmented market with a large number of foreign and domestic players," says Dr Manu Chaudhary, joint managing director Venus Remedies. Biologics and targeted therapy to overtake chemotherapy With the emergence of new technologies and a greater understanding of the biological basis for cancer evolution, the molecular changes that distinguish malignant cells from normal cells are becoming increasingly apparent. This offers a growing range of potential drug targets in the form of altered gene expression, proteins and corrupted pathways. The increased selectivity offered by these unique targets offers developers the opportunity to explore more effective and less toxic molecular targeted treatments. Experts believe that the global cancer market is going to be driven by the biologics. Dr Manu Jaggi who agrees says that these drugs that are now appearing on the market are just the first wave of new anti-cancer therapies. Adds Dr Jaggi, "The repertoire will expand rapidly over the next five years as more targets are identified. Some of the newest and most promising areas of cancer treatment are biologic therapies and other so-called "targeted" therapies. Since cancer cells divide and grow at an abnormal rate, biological therapy focuses on blocking the signal that tells the cancer cells to grow. Another feature of cancer cells is that they often override apoptosis and become "immortal." Targeted therapies can tell the cancer cells to undergo apoptosis. These can also make the cancer cells more recognizable to our own immune system, which can then seek out and destroy the abnormal cells. However, as per Dr Jaggi, caution must also be exerted as biologically targeted drugs are primarily cytostatic as opposed to cytotoxic, and therefore, sometimes fail as monotherapy. While targeted drugs are here to stay for at least another decade, cancer stem cells and differentiated drugs hold tremendous potential for treating cancer. Biocon is one of the few Indian companies to offer four targeted therapies in a short span of time. The success of our flagship brands,BIOMAb EGFR® and AbraxaneTM has placed Biocon among the top 10 oncology players in India. In addition, we have a wide portfolio of supportive care and cytotoxic drugs, at very affordable rates. "As of now, cytotoxics used in chemotherapy are growing at 12% whereas targeted therapies are growing at 35%.I believe this trend will continue in India given the improving treatment outcomes with safer targeted therapiescompared to the less-than-optimal safety profile of chemotherapy agents. Nevertheless, given the relatively higher cost of developing biologics and targeted therapies, the switch would happen at a slower pace in developing countries like India, where these drugs remain unaffordable for a large section of the population," says Shukrit Chimote of Biocon. Next decade is also expected to witness more combination therapies where biologics will be combined with chemotherapy to achieve a better response rate. Targeted agents currently constitute a majority of the novel drugs entering clinical trials. As per experts over 200 novel targeted drugs are under Phase I clinical trials, mostly small molecule protein kinase inhibitors or monoclonal antibody (MAb)-based blockers of cell surface receptors. It is anticipated that in this decade, such agents will also be clinically evaluated in combinations with each other. "This targeted therapy is the future and as we are moving towards high precision diagnosis with low dose which helps in targeted therapy. Low toxicity and low radiation is the key element in targeted therapy to achieve better result with very minimum or no side effect. However today chemotherapy and surgery are the most prevalent treatment options", opines Rekha Ranganathan. Dr Manu Chaudhary feels that the biologic molecular targeted therapies have driven much of the recent high growth in the oncology market, and include three leading anticancer brands. "As a consequence, a number of drug developers have tried to capitalise on the success of this therapy class, incorporating biologic agents into their pipelines." With the slowing down of the introduction of new anticancer drugs in the last decade, there is a need to improve upon existing drugs with respect to their formulations. It is possible to make existing drugs safer and more effective using novel drug delivery techniques such as nanoparticles and liposomes. New drug combinations also offer hope of better efficacy in patients. ]]> <![CDATA[Challenges in healthcare industry in India ]]> https://biospectrumindia.com/news/95/5574/challenges-in-healthcare-industry-in-india-.html https://biospectrumindia.com/news/95/5574/challenges-in-healthcare-industry-in-india-.html Mon, 26 Aug 2013 15:28:56 +0530 The Organisation of Pharmaceutical Producers of India (OPPI), the prima association of research and innovation driven pharmaceutical companies in India, held a seminar in Mumbai, titled 'Access to healthcare - Challenges and the Way Forward.' In his opening address, Tapan Ray, Director General, OPPI, deliberated upon the healtcare consumption trends in India. Setting the agenda for the seminar, he stated "Access to healthcare is a subject of immense significance for India particularly with the increasing incidences of new diseases in the country, from cancer and diabetes to chronic kidney disease and cardiovascular diseases. We need to ensure that Indians not only get prompt and easy physical access to healthcare facilities but also that they can afford the treatment.This can only be done by reducing the out-of-pocket healthcare expenditure in India, which is currently as high as 75%. The government needs to move quickly on plans for universal healthcare access and renew its focus on public health infrastructure and the health care delivery system." A recently conducted study "Understanding Healthcare Access in India - What is the Current State?'' by the IMS Institute for Healthcare Informatics has revealed that the out-of-pocket expenditure for both outpatient and inpatient treatments in India can be curtailed by a margin of 45% by addressing four key dimensions of healthcare access: Physical accessibility and location of healthcare facilities Availability and Capacity of needed resources Quality and Functionality of service required for patient treatment Affordability of treatment relative to a patient's income Providing an elaborative and significant insight into the Indian healthcare market to improve access, Amit Backliwala, Managing Director, IMS Health Information and Consulting Services, expressed "Inadequate resourcing and financing of the public sector health infrastructure negatively impacts the availability of healthcare workers and creates a poor perception of public health facilities. This forces the rural to look up to expensive treatment options, which in turn adversely impacts overall healthcare access." On the similar lines, Ranjit Shahani, President OPPI, and Vice Chairman and Managing Director, Novartis, commented "While the IMS Study provides a valuable informtion tool for policy makers and the healthcare and pharmaceutical industry as a whole, the presence of so many stake ho;ders here for the seminar signals an acceptance of the need to align efforts to advance healthcare access for all Indians." ]]> <![CDATA[Criticism around Food Security Bill ]]> https://biospectrumindia.com/features/95/5779/criticism-around-food-security-bill-.html https://biospectrumindia.com/features/95/5779/criticism-around-food-security-bill-.html Fri, 23 Aug 2013 12:20:00 +0530 Starting from the India's first green revolution, the agriculture biotechnology has played a great role in increasing the quality and productivity of important crops such as rice and wheat. Of late the overshadowing of the tremendous benefits offered by the sector due to various controversies have made it difficult for this industry to expand its base. Now the introduction of food security bill has also renewed debate on how can the sustained flow of food grains be maintained through increased production. Whether the bill can meet its purpose or not is a different case but most of the experts seem to be on the same page as far as its importance and revamp of agriculture system is concerned. More food means more agri-output Ram Kaundinya, Chairman, ABLE AG (Association of Biotech Led Enterprises - Agriculture Group) feels that this is surely a very progressive and socially relevant legislation. He says, "Despite being a welfare state, it is a sad fact that large number of our people has to suffer the depravity of hunger. With the stated objective of the Food Security Bill being addressing this malaise of society, if implemented well, this will redefine poverty and hunger. For the agriculture sector, this Bill will have huge implications. Clearly, there will be need for more food grains and pulses (if the new recommendations are factored in) which shall have to be met by enhanced productivity of land and increased profitability of the farmers." Mr Kaundinya in support of his view mentions that role of biotech has been exemplified by over 170 million hectare used for biotech crop by over 17 million farmers in over 28 countries worldwide. However, there are counter arguments too. "The very idea of this populist measure looks gloomy," says Prof. P. Balasubramanian, Department of Plant Biotechnology, Centre for Plant Molecular Biology and Biotechnology, Tamil Nadu Agricultural University. He adds, "One can figure out well that the Government is desperately trying to treat for the superficial symptoms while conveniently forgetting to stem the rot lying within. The food is plenty in this country and problem is with its distribution. The lack of coordination between the state and the federal governments on this score adds insult to the injury." Noted food and trade policy analyst, Mr Devinder Sharma while articulating his point of view mentioned, " The path to hell is always paved with good intentions. The bill is no exception. Although I agree that there is an urgent need to reach out to the deprived population, but what is more important is to ensure that the poor and hungry are able to fish for food rather than depend upon doles. Unfortunately, the people who designed the bill looked at only the distribution aspects, on how to reach food to the hungry millions. Where they missed out is the strong linkage food security has with agriculture. This disconnect with sustainable agriculture will add on to the hungry population in the years to come." Mr Sharma also talks about the focus on food security system based on local production, local procurement and local distribution. He says, "Take the case of Karnataka. It has launched a Re 1/kg rice scheme. newspaper reports tell us that Karnataka is buying rice from Chhatisgarh at about Rs 27/kg to distribute it to the hungry at Re 1/Kg. In my understanding this is not the right approach. The effort should have been to make agriculture in Karnataka profitable enough so as to increase production within the State. Karnataka can't go on creating land banks, displacing farmers and then importing food." Rajesh Krishnan, Sustainable agriculture campaigner, Greepeace thinks that Food security Bill was a landmark opportunity for the govt to ensure sustainable food security to the country. But by truncating it to the levels that it has come to and by pushing it as an ordinance it has become more of a 'limited grain entitlement Act' and a political gimmick. If the govt was serious about food security, they would've ensured that there are provisions in this legislation for ensuring sustainable production of diverse food crops. Unfortunately the Food security ordinance has nothing new to offer. It is just old wine in new bottle. The only thing that is appreciable is the statutory right of Right to food for those covered under the already existing food entitlement schemes. Agricultural research holds key to productivity "Without the right price, why farmers should go in for producing more and more of it?,"asks Prof. Balasubramanian. "How many food crops which came to fruition through biotech research have been permitted by this government? As long as our food policy is going to be decided only by the external forces and not by the pressing needs of the masses, the Indian biotech industry whose hands remain tied cannot deliver the goods. Bioscientific methods have a lot to contribute in terms of yield and quality (The best example is Bt cotton) only when the vested interests like Green Forces are going to be kept away." Ram Kaundinya, strongly believes agri biotech sector will have an important role to play. "Biotech can help in addressing biotic and abiotic stresses that our crops undergo and help the farmers to increase the productivity of the land in the face of such stress factors. We have 100m ha of rainfed land in the country and there is a need to mitigate the risks of these farmers and help them to produce more if we have to address the supply side of the equation involving the food security bill. It is important to address the supply side if we have to ensure the sustainability of the measures being proposed on the demand side. The seed and biotech industry can help in propelling the growth of Indian agriculture. By enhancing productivity, the agri biotech sector will surely be in a position to contribute to realizing the objectives of the bill." "While Agri Biotechnology has some scope in increasing productivity, one also needs to ensure that risky biotechnologies like Genetic Engineering and its products like GM crops are not promoted." opines Rajesh Krishnan sustainable agriculture campaigner, Greenpeace. He adds further, "Data shows that biotechnology techniques like marker assisted breeding are actually delivering on ground and these should be promoted. Here again one needs to ensure that this does not lead to monopolies over seeds. However Mr Krishnan is of the opinion that any technology that leads to control of seeds being taken away from farm communities should not be promoted. Striking a different note, Devinder Sharma feels that agricultural biotechnology companies can only aggravate the agrarian crisis. "There is nothing that the biotechnology companies/industry can do to ensure food security. Let us be very clear the biotech industry has failed to deliver on its promise of increasing crop productivity. All the promises it made some 30 years back, including developing plants with the ability to fix atmospheric nitrogen, have fallen flat. What India needs is to scale up the Non-pesticides management (NPM) programme that now covers approximately 10 million acres in Andhra Pradesh." Despite neglect, the sector can still deliver Many agriculture activists believe that instead of suggesting technological solutions, government and industry must help in providing farmers an assured monthly income. Few also suggest a shift in the paradigm towards ecological farming, which ensures livelihood security for farm communities, sustainability of natural resources of water, soil, biodiversity and climate which are essential for farming and food security for the country. Agreeing with this point of view, Devinder Sharma says,"Forty two percent of farmers want to quit agriculture if given a choice. Business as usual will only add on to the prevailing agrarian crisis. The focus must shift immediately on increasing farm incomes through State Farmers Income Commission." Giving a different perspective, Ram Kaundinya mentions, "Agri-biotech, by its sheer dynamism, and potential to arrest yields losses stand to significantly enhance the incomes of farmers, provide sustained food supplies and strengthen country's standing in the world market. There is no doubt that more investments are required in creating more infrastructural support for agriculture (roads, power, storage facilities, etc) and we need more investment in research." One of the critical factors that will ensure long-term success of this bill would be on the creation of an enabling environment for enhancing the productivity of our agriculture through the adoption of modern technologies and practices. Apart from that the increased research spending in agricultural research in seeds, crop protection and plant nutrition will help in creating sustainable agriculture that can meet our future food demand. The farmers have to be empowered and encouraged through much better system in place. Most important are those who are at the receiving end of the chain who most often don't get the benefit. The bill will be relevant only if there is proper corruption free system to feed them. These are the areas that the government needs to focus on. ]]> <![CDATA[ Abott Named as the Best Company to Work]]> https://biospectrumindia.com/news/95/5949/-abott-named-as-the-best-company-to-work.html https://biospectrumindia.com/news/95/5949/-abott-named-as-the-best-company-to-work.html Fri, 23 Aug 2013 11:44:53 +0530 Abott with a portfolio of leading, science-based offerings in diagnostics, medical devices, nutritionals and branded generic pharmaceuticals was recongnised as 'The Best Company to Work for' in the pharmaceutical and healthcare sector. The global healthcare company was also listed in the top 25 Business Today's 'Best Companies to work for' among Indian business in all sectors. The prestigious Business Today annual ranking is based on a detailed survey in which employes rank their employers on criteria such as career growth prospectus, financial compensation, work life balance, stability and other HR practices. In addition to the Business today ranking Abott was also recongnised as on of India's 'Most Admired Companies' by Fortune India in the Pharma and Healthcare sector. "Abott is proud to help employees grow with challenging and rewarding career opportunities," expressed Bhaskar Iyer, divisional vice president, Abott Established Pharmaceuticals, India. He also added "It is a great homour to be recongnised as one of India's best employers. ]]> <![CDATA[Drug approvals without clinical trials on decrease: Govt data]]> https://biospectrumindia.com/news/95/3386/drug-approvals-without-clinical-trials-on-decrease-govt-data.html https://biospectrumindia.com/news/95/3386/drug-approvals-without-clinical-trials-on-decrease-govt-data.html Thu, 22 Aug 2013 14:13:00 +0530 A drug banned or restricted in one country may continue to be marketed in other countries as the respective government examines the usage, doses, indications permitted etc. and overall risk-benefits ratio and takes decisions on the continued marketing of any drug in that country. The state drug control departments conduct raids to check the sale of banned drugs under their jurisdiction. Recently the CDSCO had also conducted raids in 2011 in and around Delhi and in Mumbai to check the withdrawal of Gatifloxacin, Tegaserod and Rosiglitazone after these drugs were prohibited. It was found that in 29 shops, banned drugs were sold after the issue of notification in the Gazette of India and in the remaining shops banned drugs were found stocked, but were not sold after the date of the said notification. Action was initiated in those cases as per the provision of the Drugs and Cosmetics Act, 1940. Twenty three cases of new Fixed Dose Combinations (FDCs) considered as new drugs were also found to be licenced by State Licensing Authorities (SLAs) without approval of the Drugs Controller General (India). SLAs in all these cases were asked to take action under the Drugs and Cosmetics Act, 1940. The number of drugs (new drug molecules of non-biologicals and biologicals) approved by CDSCO without clinical trials in the country has reduced over the period of time. During the year 2010, the number of drugs approved without clinical trial remained at 13 which went to three in 2011, eight in 2012 and finally two upto July, 2013. These statistics were revealed by the union minister of health and family welfare, Ghulam Nabi Azad in written reply to a question in the Parliament. Elaborating on the procedures, Azad mentioned, "New drugs are approved by the CDSCO based on non-clinical data, clinical data of safety and efficacy of drug, regulatory status in other countries etc. as per the guidelines and requirements specified in Rule 122A, 122B, 122D and Schedule-Y of the Drugs and Cosmetics Rules, 1945. However, as per Rule 122 A (2) and Rule 122 B (3), the requirement of clinical trials may not be necessary if the drug is of such a nature that the Licensing Authority may, in public interest, decide to grant permission to import / manufacture the new drug on the basis of data available from other countries." "Further, as per clause 1 (3) of Schedule Y, for drugs indicated in life threatening / serious diseases or diseases of special relevance to the Indian health scenario, clinical data requirements may be abbreviated, deferred or omitted, as deemed appropriate by the Licensing Authority. For grant of permission to import / manufacture the Fixed Dose Combinations (FDC), the requirements are prescribed under Appendix-VI of Schedule-Y. As per these requirements, clinical trial on Indian patients is required in certain category of FDCs", explained the minister. ]]> <![CDATA[Praj becomes first to set up 2G cellulosic ethanol plant ]]> https://biospectrumindia.com/news/95/7105/praj-becomes-first-to-set-up-2g-cellulosic-ethanol-plant-.html https://biospectrumindia.com/news/95/7105/praj-becomes-first-to-set-up-2g-cellulosic-ethanol-plant-.html Thu, 22 Aug 2013 14:02:00 +0530 Praj Industries, the global process solutions company for bioethanol, alcohol and brewery, water and wastewater and critical process equipment has emerged as the first Company in South Asia to set up an integrated 2nd Generation (2G) Cellulosic ethanol plant. Praj's Eeecutive chairman Mr. Pramod Chaudhari did the groundbreaking recently at Shirala in Sangli District in Maharashtra (India) along with chairman of Viraj Alcohols and Allied Industries Limited (VAAIL), Mr Mansinghrao Naik. The 2G Cellulosic ethanol demo plant will operate on different variety of biomasss with a capacity of 100 dry tonnes of biomass per day, which includes agricultural wastes such as corn stover, cobs and bagasse. The demo plant will enable Praj to consolidate its 6 years of R&D efforts, starting with laboratory trials to pilot scale trials. The same plant will also enable Praj to develop various biochemicals and bioproducts. The demo plant will seek to demonstrate various technical parameters including optimization of water and energy integration and its impact on the capex and opex. The plant will also develop the entire value chain including biomass handling and biomass composition and its impact on the operations. Praj expects the project cost to be in the region of US$ 25 million (Rs 145-150 crore). For this project, Praj will associate with VAAIL, an existing ethanol producer located in Western Maharashtra and a long term client of Praj. VAAIL will provide the land and allied services for the smooth operation of the project. Commenting on the ground-breaking, Mr Pramod Chaudhari, executive chairman, Praj Industries, said, "Ground breaking of 2G Cellulosic ethanol plant is a giant leap in biotechnology and towards a more sustainable world. The greenhouse gas savings from Cellulosic ethanol is greater than those from 1st Generation crop-based biofuels as well as fossil-based fuel and hence this project will play a vital role in reducing carbon footprints. The project site at Shirala gives us a locational advantage in terms of sourcing of biomass, utilities and manpower. We are delighted to work with VAAIL who has been our long term client." On this occasion, Mr. Mansinghrao Naik, chairman, VAAIL said, "Viraj has more than a decade?s experience in operating ethanol plants based on both, molasses as well as grains. Praj has supplied both these plant. It gives me great pride to be associated with Praj as it will give us the opportunity of participating in a path- breaking project." ]]> <![CDATA[Health ministry: Have strong policy to tackle antimicrobial resistance]]> https://biospectrumindia.com/news/95/5212/health-ministry-have-strong-policy-to-tackle-antimicrobial-resistance.html https://biospectrumindia.com/news/95/5212/health-ministry-have-strong-policy-to-tackle-antimicrobial-resistance.html Thu, 22 Aug 2013 13:01:04 +0530 The government has already framed a comprehensive policy, namely, the National Policy for Containment of Antimicrobial Resistance, to address the problem of multi-drug resistance due to widespread and indiscriminate use of antimicrobial / antibiotic drugs in the country. The policy was developed by a Task Force constituted under the chairmanship of director general of health services (DGHS) to address the problem. The policy is available on the web-site of the ministry of health and family welfare as revealed by its minister, Mr Ghulam Nabi Azad in the Parliament on August 20, 2013. The salient features of the policy are to review the current situation regarding manufacture, use and misuse of antibiotics in the country, recommend the design for creation of a national surveillance system for antibiotic resistance and to initiate studies documenting prescriptions patterns & establish a Monitoring system for the same. Besides that the enforcement and enhancement of regulatory provisions for use of antibiotics in human and veterinary and industrial use, also form the part of policy. Other features are to recommend specific intervention measures such as rational use of antibiotics and antibiotic policies in hospitals and diagnostic methods pertaining to antimicrobial resistance monitoring. "Under the 12th five year plan, there is the target to initiate steps for the containment of antimicrobial resistance in the country through 30 lab networks and awareness activity for rational use of antibiotics. The aforesaid Task Force had also recommended insertion of a separate schedule under the Drugs & Cosmetics Rules to regulate the sale of antibiotics, especially 3rd and 4th generation antibiotics in the country," said the minister. In pursuance of that recommendation, the government issued a draft notification GSR 228 (E) dated 20-03-2012 for inviting comments from the public proposing to insert a new schedule in the Drugs and Cosmetics Rules, 1945 containing habit forming drugs and certain anti-TB drugs along with antibiotics. The container of the drugs covered under new schedule will be labelled with a symbol `Rx` which shall be in red colour and conspicuously displayed on the left corner of the label with the warning - `It is dangerous to take this prescription except in accordance with medical advice and not to be sold by retail without the prescription of the registered medical practitioner.` ]]> <![CDATA[ Flu vaccine reduces heart attack risk ]]> https://biospectrumindia.com/news/95/3388/-flu-vaccine-reduces-heart-attack-risk-.html https://biospectrumindia.com/news/95/3388/-flu-vaccine-reduces-heart-attack-risk-.html Thu, 22 Aug 2013 11:54:44 +0530 Regular shots of influenza injections have the added benefit of reducing the risk of heart attacks in people in the 40-64 age group if they have narrowed arteries. Earlier it was believed that flu shots actually increase the risk of heart diseases. The study, reported in BMJ Open quoting the scientific journal Heart, was done by researchers at the School of Public Health and Community Medicine, University of New South Wales, Sydney by a team led by Prof Raina Macintyre. The study involved 559 heart patients over the age of 40, and was done between 2008 and 2010. The results of the study were interesting. An influenza attack in patients did not increase the risk of triggering heart disease. And in nearly half the patients studied, a prior vaccination for flu ( influenza) actually reduced the risk of developing heart attack by half. This was contrary to the notion that infections such as flu actually encourages blood to thicken or block arteries leading to heart attacks. Based on these results, researchers recommend that people in the age group of 40-64 too should be included in the influenza vaccination programme. This age group has so far been excluded from flu vaccination as a precautionary measure against onset of heart disease. " As such , even a small effect of influenza vaccination in preventing heart attacks may have a significant population heath gains," wrote the researchers, Prof Macintyre and Dr Anita Heywood. ]]> <![CDATA[BioEnergy Zones Lead the Way Towards Socially Inclusive and Economically Sustainable Livelihood]]> https://biospectrumindia.com/news/95/7440/bioenergy-zones-lead-the-way-towards-socially-inclusive-and-economically-sustainable-livelihood.html https://biospectrumindia.com/news/95/7440/bioenergy-zones-lead-the-way-towards-socially-inclusive-and-economically-sustainable-livelihood.html Thu, 22 Aug 2013 11:50:00 +0530 The BioEnergy Zones will produce renewable energy through elite biofuel trees developed by VayuGrid and deliver a triple net social, environmental, and economic benefit to Haiti. The zones will be developed in non-arable land across Haiti to supply biodiesel, cooking briquettes, and high-protein animal feed. Social benefits will be realized through jobs and economic opportunities for the communities servicing the BioEnergy Zones; environmental benefits via renewable energy and reduction of deforestation through biofuels, and economic benefits by way of an agriculture financial model that is sustainable without government subsidies. Sonamar S. A., based in Haiti, has an agreement with the Energy Ministry in Haiti for development of energy crops and has access to large tracks of barren land. As the local execution partner, Sonamar will work with local communities to develop the services-based ecosystem around BioEnergy Zones, creating long term opportunities for jobs and income within the communities. "We see great benefit in developing a high yielding crop that not only produces clean energy, but will also supply the cooking fuel, to significantly reduce the large scale deforestation across Haiti," said Alix Douyon, president of Sonamar S. A. "The environmental benefits of building back the environment while creating the much needed jobs will be a game changer for Haiti," expressed Stephany M Sirius, vice president of International Business Development for Sonamar S.A. "There is significant attention on how to make lasting changes in Haiti," said Douglas Peterson, CEO of VayuGrid. "We are pleased to develop this agreement with Sonamar and expect significant benefit for Haiti directly and foresee that Haiti will become a demonstrator for the region for deploying large scale and sustainable renewable energy projects." The initial project will be for 1,000 acres and supply over 1.2 million gallons of biodiesel per year, and 15,000 tons of green coal. The project will be expanded to over 20,000 acres over the next 4 years. VayuGrid Marketplace Services Pvt. Ltd., is a Bangalore-based company focused on building biofuel supply chains around Elite Pongamia to address the challenge of Predictability in the renewable fuel supply chain, from upstream plantation to midstream processing to downstream markets. Sonamar S.A is a corporation created in Haiti in 2010 for the purposes of bringing industrialization and building opportunities in agriculture and mariculture related ventures that can benefit the environment, energy needs as well as meeting the foods challenges of tomorrow. ]]> <![CDATA[Centers for Disease Control Grant for Manipal University]]> https://biospectrumindia.com/news/95/3387/centers-for-disease-control-grant-for-manipal-university.html https://biospectrumindia.com/news/95/3387/centers-for-disease-control-grant-for-manipal-university.html Wed, 21 Aug 2013 17:03:15 +0530 Manipal Centre for Virus Research (MCVR), a research department of Manipal University has been awarded the Research Cooperative Agreement Grant worth USD 1.143 million by the Centers for Disease Control and Prevention (CDC), United State Department of Health and Human Services through the Coordinating Office of Global Health (GH). The grant was awarded for the application submitted by Dr. G Arunkumar, Professor and Head, MCVR and Dr TMA Pai endowed Chair in Translational Virology for the project "Hospital Based Surveillance of Acute Febrile Illness in Western Ghat Region of India" for detecting etiologies of emerging infectious disease in the Western Ghats region of Karnataka and Kerala. The other departments of Manipal University involved in this grant are Departments of Statistics, Public Health, Microbiology (Kasturba Medical College, Manipal & Mangalore), Community Medicine (Kasturba Medical College, Manipal) and School of Communication. The CDC grant, in addition to providing financial aid also provides technical support from the sponsoring agency leading to significant capacity building in the host institution. The grant opens up exciting prospects of international research collaborations and additional funding. Dr. H Vinod Bhat said "The grant from CDC is a landmark achievement for Manipal University in its research endeavors. The National Institute of Virology, Pune and the National Centre for Disease Control, Delhi, both under the Ministry of Health and Family Welfare, Government of India are the only other previous recipients of such a grant from CDC." The Manipal Centre for Virus Research was established to augment the diagnostic virology capacity and to enhance research activities at the University. It supports the associated University hospitals and the health departments of the neighboring states with diagnostic services for viral diseases. The Indian Council of Medical Research (ICMR) and Ministry of Health and Family Welfare, Government of India has identified virology as a focus area in the public health sector and initiated the process of establishing virology laboratories across the country and Manipal Centre for Virus Research is one among them. Webometrics has recently announced Manipal University to be the highest ranked private institution in India. ]]> <![CDATA[Experts discuss threats to wheat supply, commemorate Dr Borlaug's legacy]]> https://biospectrumindia.com/news/95/3642/experts-discuss-threats-to-wheat-supply-commemorate-dr-borlaugs-legacy.html https://biospectrumindia.com/news/95/3642/experts-discuss-threats-to-wheat-supply-commemorate-dr-borlaugs-legacy.html Wed, 21 Aug 2013 15:00:00 +0530 "Just as important as developing rust-resistant varieties of wheat is getting rid of the old 'rust sucking' varieties that pose a major threat to wheat production and food security in the path of stem rust and yellow rust," said Dr Ronnie Coffman, Cornell professor of plant breeding, principal investigator, director of the Durable Rust Resistance in Wheat (DRRW) project and vice chair ofthe Borlaug Global Rust Initiative (BGRI). Dr Coffman is among the top wheat scientists from around the world who will convene in New Delhi, India, Aug. 19-22, to attend the 2013 BGRI Technical Workshop jointly convened with the ICAR at New Delhi. They will discuss progress and challenges in protecting the world's wheat supply from rust and commemorate the 50th anniversary of Norman E. Borlaug's introduction of high-yielding wheat varieties to India. Reflecting the global compass of the initiative, the workshop will be attended by over 400 delegates from major wheat growing nations from all the continents of the world. Participating nations, apart from the South Asian nations of India, Bangladesh, Pakistan, Afghanistan, Nepal and Bhutan will include the nations of the North and South Americas, Europe, Central Asia, Middle East, the Maghreb region, Africa, Australia, and East Asia. Indian has been the earliest beneficiary of the Borlaug legacy that has contributed to the country accomplishing food security and economic prosperity. "India lies at the heart of the greatest contiguous wheat growing region in the world. As the world's largest agricultural research organization, the Indian Council of Agricultural Research has moved decisively to reduce the area planted to UG99 susceptible wheat varieties while providing our farmers with resistant varieties screened in collaboration with our BGRI partnersin Kenya and Ethiopia," said ICAR director general Dr S Ayyappan. "This global partnership has been central to our success in working with our neighboring countries to prepare for the arrival of UG99, which will relentlessly ignore political boundaries when it inevitably extends to South Asia." "The wheat revolution in India triggered by Dr Borlaug has sustained its relevance due to the continued engagement of Indian Scientists inenhancing wheat productivity and production with consistent focus on food self sufficiency. The Indian Council of Agriculture Research has gained from global convergence of the scientific effort in mitigating rust in wheat and has contributed to the global effort in addressing the prevention of the rust disease in wheat", added Dr S Ayyappan. "We are significantly closer to our goal of protecting the global wheat crop from rust diseases but the vast wheat-growing region that stretches across North Africa all the way to India and China - two of the world's largest wheat-growing nations - is still vulnerable," said Coffman. He noted that India has made commendable progress in reducing the amount of farmland planted to susceptible varieties. An estimated 85 percent of wheat in production, including most wheat grown in the Americas, Asia and Africa, is susceptible to stem rust Ug99 and its variants. Coffman said that stem rust can act like a "biological firestorm," turning fields of wheat into blackened stubble with no grain. "India's wheat scientists have been remarkably diligent in getting farmers to reduce the amount of land that is planted to the highly susceptible mega variety PBW343," said Dr Ayyappan. In the last five years, the number of hectares of PBW343 has shrunk from more than half the acreage to a quarter of the area of wheat cultivated. "We are more and more successful in getting new varieties into farmers' hands," he said. Commemorating Norman E. Borlaug's Legacy Dr Borlaug, the Father of the Green Revolution, who first came to India in 1963, often saidthat "rust never sleeps." In 2005, after confirming that a form of stem rust called Ug99 had overcome the resistance gene he and others had developed for wheat more than 50 years before, Dr. Borlaug began his campaign to make the world pay attention to the new threat to global food security. He launched the BGRI in 2005. "To advance his legacy and vision to alleviate hunger in the most sustainable and nutritious way, my father would urge us to harness all the tools of biotechnology that we have before us," said Jeanie Borlaug Laube, Dr. Borlaug's daughter, who is the chairperson of the BGRI. Four farmers who worked with Dr. Borlaug in the 1960s and '70s will address workshop participants during the opening festivities at Vigyan Bhawan on August 19. The President of India, Pranab Mukherjee made the inaugural remarks. Appreciating the continuance of work led by Dr Borlaug, he said that research on wheat continues unabated in India is a legacy of Dr. Borlaug. Since 1965, four hundred three wheat varieties have been developed and released for commercial cultivation in the six wheat growing zones of the country. Working to Ensure Continued Food Security Stem rust can cause farmers to lose entire crops, but an equally important yellow (or stripe) rust is also causing severe losses worldwide. Like stem rust, yellow rust has become animmediate threat with the emergence of new, highly aggressive strains that knock out genetic resistance in many popular varieties of wheat."The only manageable solution for farmers who cannot afford fungicides when rust hits is to replace their crop with new rust-resistant varieties," Coffman said. "Planting only five percent of a nation's wheat fields with seed from resistant varieties would allow replacement of susceptible varieties within a year, if Ug99 should appear. "We have the technology to prevent a tragedy that could destroy crops in some of the world's most important wheat-producing regions," said Coffman. "But it is difficult to get rustresistant wheat seed multiplied fast enough and into the hands of the people who need it." It is difficult to convince farmers to change varieties until they have suffered losses or unless a new variety promises significantly increased yields."India has been an important partner in the BGRI since the beginning. We welcome the Indian Council of Agricultural Research (ICAR) and their proactive approach to surveillance and breeding," said Coffman. He noted that Indian scientists have been extremely vigilant in sending promising wheat lines to rust screening facilities in Ethiopia and Kenya, and that Indian wheat breeders are making good progress in developing durably resistant wheat varieties. Working closely with technical support from Sathguru Management Consultants, Indian scientists at ICAR have developed a comprehensive surveillance data network for South Asia that is being deployed in India, Bangladesh, Nepal, Bhutan and Pakistan to track rust diseases of wheat. The deployment of Information technology solution developed by Sathguru, a BGRI partner in tracking rust pathogens, is widely deployed in the South Asia to generate reliable information for rust prevalence in key wheat growing regions. "The use of information technology solutions has facilitated BGRI partners in generating nation-specific information that is extremely useful in tracking the rust incidence and initiate preparedness for rust mitigation" said Kannan Vijayaraghavan, director of Sathguru and regional coordinator of the DRRW project. India's Rust Preparedness"Global food security can rise and fall with the success or failure of India's wheat crop," said Coffman. "Because India is the second largest wheat producer and consumer in the world, threats to its wheat crop or any significant decline in production could have an immediate impact on global food security." "Anticipatory contingency plans have been chalked out aiming at immediate and long term strategies to manage stripe rust along with leaf rust and stem rust," said Dr Indu Sharma, director of the Directorate of Wheat Research, speaking about India's preparedness in meeting the threat of rust. Dr Sharma said strategies include awareness campaigns in the farming community and extension workers through press, electronic media and literature in local languages; planting of wheat disease monitoring (trap) nurseries including SAARC nurseries in all the strategic areas and regular monitoring throughout the crop season; monitoring the wheat crop from December onwards at regular intervals of 15-20 days and initiating stripe rust management activities that includes use of fungicide to manage rust in disease-prone areas by agricultural scientists, extension specialists and agricultural officers working with the Department of Agriculture; analysis of variability in samples from off season locations to identify pathotypes that infect the wheat crop during the season based on routinely used differential set and integrating molecular tools for genetic diversity. Wheat is the second leading grain crop in India after rice, with 30 million hectares under cultivation. Annual production stands at 92.46 million tons, which is 13.2 percent of the world's production. ]]> <![CDATA[Statue of Dr Norman Borlaug unveiled at New Delhi]]> https://biospectrumindia.com/news/95/3019/statue-of-dr-norman-borlaug-unveiled-at-new-delhi.html https://biospectrumindia.com/news/95/3019/statue-of-dr-norman-borlaug-unveiled-at-new-delhi.html Wed, 21 Aug 2013 14:43:00 +0530 At the inaugral function, the minister for agriculture and food processing industries, Sharad Pawar highlighted the contributions of Dr Norman E Borlaug in Indian agriculture and said that Dr Borlaug always considered himself to be a teacher, as well as a scientist. He added further,"Today, several thousand men and women agricultural scientists from more than 50 countries are proud to say they were Norman Borlaug's student. We can think of no greater tribute to Dr. Borlaug than to carry on the work to which he dedicated his life, applying agricultural science for humanitarian benefits." Pawar also thanked CIMMYT for getting the statue of Dr Borlaug installed in the campus of ICAR, New Delhi. A replica of Dr Borlaug's statue was presented to the minister on the occasion. Ms Jeanie Laube-Borlaug, chairperson of Borlaug Global Rust Initiative (BGRI) and daughter of Dr Norman Borlaug expressed her happiness on participating in this event and remembered the association of Dr Borlaug with India and Indian farmers. She also said that her father's heart and soul inhabit in Indian agriculture. Dr R S Paroda, chairman, TAAS; Dr R B Singh, president, National Academy of Agriculture Sciences and Dr Sanjay Rajaram, a close associate of Dr Borlaug also gave their valuable remarks on the occasion. Earlier, Dr Thomas A Lumpkin, Director General, CIMMYT (USA) welcomed the dignitaries and highlighted the journey of Dr Borlaug. Foreign delegates and senior officials and scientists from CGIAR institutions, ICAR and other national and international organization of repute were also present on the occasion. Dr S Ayyappan, secretary, DARE and director general, ICAR proposed vote of thanks. ]]> <![CDATA[CARESTREAM DRX-Evolution Optimizes Image Quality for Pediatric X-ray Exams ]]> https://biospectrumindia.com/news/95/6201/carestream-drx-evolution-optimizes-image-quality-for-pediatric-x-ray-exams-.html https://biospectrumindia.com/news/95/6201/carestream-drx-evolution-optimizes-image-quality-for-pediatric-x-ray-exams-.html Wed, 21 Aug 2013 12:28:00 +0530 Children's Hospital at Erlanger (Chattanooga, Tenn.) recently implemented a CARESTREAM DRX-Evolution with Carestream's long-length imaging software to optimize image quality for all types of X-ray images including long length exams for pediatric surgeons and other specialists. "We equipped our DRX-Evolution with high-resolution cesium iodide detectors to enhance image quality and help reduce dose. Our specialists immediately commented on the additional level of detail they are able to see in the X-ray images," said Byron Stutz, Children's Hospital at Erlanger's Chief Radiologic Technologist. The radiology department conducts hundreds of long length images each month for joint surveys, and for diagnosing and treating conditions including scoliosis, hip dysplasia and other abnormalities. Carestream software adjusts the exposure discrepancies between images and compensates for the latitude differences therefore providing presentation that is individually optimized for each image and its corresponding analytical region. The image processing algorithm then stitches the individually optimized images together to create a smooth and seamless composite image for diagnosis. The CARESTREAM DRX-Evolution DR Room is a versatile digital radiography system with configurable, modular components that combine to fit the space, workflow and budget requirement of each healthcare facility. This system can perform a wide variety of general radiographic exam with convenience, productivity and patient comfort. ]]> <![CDATA[Venus Remedies eyes big profits from European markets]]> https://biospectrumindia.com/news/95/3367/venus-remedies-eyes-big-profits-from-european-markets.html https://biospectrumindia.com/news/95/3367/venus-remedies-eyes-big-profits-from-european-markets.html Wed, 21 Aug 2013 11:56:00 +0530 Venus Pharma GmbH, a subsidiary of Venus Remedies Limited, one of India's fastest growing research-based pharmaceutical companies, has made big strides in the global market by bagging marketing authorisation (MA) approval from France for meropenem, a generic broad spectrum antibiotic injectable. It has signed a non-exclusive marketing rights deal with generic giant Mylan to sell meropenem in France, world's fifth largest pharmaceutical market with a market share of 3.8%. Terming it as a major achievement, Ashutosh Jain, Executive Director-cum-Chief Operating Officer (COO), Venus Pharma GmbH, said, â€œWe are proud of our drug regulatory capabilities, which have enabled the company to emerge as a key player in the European Union (EU)markets. Driven by our MA grants, we are all set to grab the maximum share in the $270-million meropenem market in the EU in the near future.â€? Meropenem is an off-patented generic broad spectrum anti-bacterial agent of carbapenem family, which fights diseases with a broad range of serious infections caused by single or multiple susceptible bacteria in both adults and children. â€œCurrently, Venus is generating good revenue from the export of meropenem to EU markets.In 2012-13, we generated a business of about Euro 5 million from meropenem exports. This figure is expected to double by the end of this financial year. We have plans to capture the meropenem share in other lucrative markets as well, including Australia, Spain, Switzerland, South Africa, Malaysia and Gulf Central Committee (GCC) countries where the registration process is in advanced stages,â€? said Dheeraj Aggarwal, Chief Financial Officer (CFO), Venus Remedies. Venus has already received marketing authorisation for meropenem from the UK (Medicines and Healthcare products Regulatory Agency), Austria, Denmark, Finland, Ireland, Germany, Netherlands, Poland, Slovenia, Slovakia, Sweden, Portugal, Czech Republic, Cyprus, New Zealand and Mexico. It has also achieved a major breakthrough in Balkan countries by getting marketing approvals from Bosnia & Herzegovina and Croatia. Meropenem sales, which are to the tune of $906 million across the globe, are expected to cross the $1,000-million mark by the end of 2013. Besides, France accounts for a $36.76-billion share in the $962-billion global pharmaceutical market. Venus, in association with its partners, is already offering the best quality meropenem to 35 countries. It aims to penetrate the market in 15 more countries by the first quarter of 2014. ]]> <![CDATA[Molecule that causes type 2 diabetes identified]]> https://biospectrumindia.com/news/95/7558/molecule-that-causes-type-2-diabetes-identified.html https://biospectrumindia.com/news/95/7558/molecule-that-causes-type-2-diabetes-identified.html Tue, 20 Aug 2013 16:40:00 +0530 One need not be a drug addict to increase the chances of developing diabetes. Action by a natural messenger in the human body Endocannabinoid which is similar to the active compound in Marijuana is what is triggering the onset of diabetes, according to researchers at the US National Institute on Alcohol Abuse and Alcoholism(NIAAA) and National Institute of Diabetes and Digestive and Kidney Diseases. In studies in rats conducted by Dr George Kunos, scientificcdirector of NIAAA and Dr Monica Skarulin at the Diabetes center along with other researchers indicate that endocannabinoid activates macrophages in the pancreas. This in turn leads to activation of a protein complex within macrophages called Nirp3 inflammasome. This protein complex then releases molecules that cause the death of beta cells in the pancreas and leads to the onset of type 2 diabetes by reducing insulin production. Macrophages are immune system cells that are present in human tissue and have a key role in eliminating pathogens and dead cells from the body. " This study is a significant milestone in an ongoing exploration of the endocannabinoid system's role in the metabolic complications of obesity," said NIAAA's acting director Dr Kenneth R Warren, in a statement released by NIH on August 19. The study has appeared in the online edition of science journal, Nature Medicine. Added the lead author, Dr Kunos: " The identities of the molecular and cellular actors in the inflammatory processes that underlie type 2 diabetes have remained elusive. Our study connects endocannabinoids to an inflammatory cascade leading to the loss of beta cells in the pancreas, which is a hallmark of type 2 diabetes." In the study obese rats were fed chemical compounds that depleted microphages that led to inflammation activation and onset of type 2 diabetes. Then when these rats were genetically altered to rid them of the endocannabinoid receptors, progression of type 2 diabetes slowed. This has led to the surmise that by selectively blocking the expression of cannabinoid receptors on macrophages, the beta cells in pancreases could be protected and thus reduce the severity of type 2 diabetes. The researchers have concluded that it may be possible to identify suitable drug targets that could reverse the action of cannabinoids in triggering inflammation and death of beta cells leading to type 2 diabetes. " To understand type 2 diabetes, a public health threat that affects young and old alike, we need to consider all the factors at play, " said Dr Monica Skarulis who was also part of the study. " We hope that what we have learned from this research will help us develop new strategies to prevent and treat the condition." Researchers from the University of Colorado Medical Campus, Aurora, and the University of Massachusesetts Medical School, Worcester were also part of the study. ]]> <![CDATA[Phenomenex extends Phreeâ„¢ Phospholipid Removal sorbent family to tube format]]> https://biospectrumindia.com/news/95/5129/phenomenex-extends-phree-phospholipid-removal-sorbent-family-to-tube-format.html https://biospectrumindia.com/news/95/5129/phenomenex-extends-phree-phospholipid-removal-sorbent-family-to-tube-format.html Tue, 20 Aug 2013 11:47:00 +0530 First offered in 96-well plates for automated applications, the Phree sorbent in 1 mL tubes is ideal for users with lower throughput needs as well as for labs who do not have the ability to automate. Phree delivers fast cleanup of plasma samples in pharmaceutical and clinical research laboratories. Phree in tube format can be used with a vacuum manifold, a positive pressure system or with a centrifuge. In one step, Phree removes both proteins and phospholipids, including 99.0 to 100 percent of lysophosphatidyl and phosphatidyl cholines, which are not removed when a simple protein precipitation is performed. Successful chromatographic analysis of plasma samples requires the removal of both proteins and phospholipids, which can clog HPLC/UHPLC columns. Phospholipids can also cause ion suppression and over time will reduce sensitivity due to buildup on the mass spectrometry source. Phree Phospholipid Removal products provide high recoveries of acids, bases and neutrals without the need for method development. "Customer feedback on our Phree sorbent has been very positive, with reports of significant time savings, cleaner samples and longer column life," said Erica Pike, brand manager for Phenomenex. "Phree users are getting better mass spec results with no ion suppression." The Phree Phospholipid Removal sorbent line is an extension of Phenomenex's sample preparation portfolio, which includes protein precipitation, filtration and solid phase extraction products. Phenomenex is a global technology leader committed to developing novel analytical chemistry solutions that solve the separation and purification challenges of researchers in industrial, clinical research, government and academic laboratories. ]]> <![CDATA[Govt to strengthen anti TB measures]]> https://biospectrumindia.com/news/95/7136/govt-to-strengthen-anti-tb-measures.html https://biospectrumindia.com/news/95/7136/govt-to-strengthen-anti-tb-measures.html Mon, 19 Aug 2013 14:45:35 +0530 As per the WHO estimates, 320,000 Tuberculosis (TB) patients died during 2010. The WHO Global TB Report 2012 puts the estimated that the death rate per 100,000 populations due to TB has declined form 38 in 1990 to 27 in 2010 and further down to 24 in 2011. However, the absolute number of estimated TB deaths is high due to large population. Recently the union minister of health and family welfare, Ghulam Nabi Azad mentioned in the Parliament that to reach the unreached, the Revised National Tuberculosis Control Programme (RNTCP) has envisaged many strategies during the Twelfth Five Year Plan period. These include the strengthening and improving the quality of basic Directly Observed Treatment Short-Course (DOTS) services and aligning with health system under NRHM. Apart from that, the focus would be on expanding efforts to engage all care providers The government also aims to keep strengthening the system and provision of quality care to the vulnerable groups including slum dwellers, tribal population etc. Besides that the other important measure include xpanding diagnosis and treatment of drug resistant TB, mproving communication, outreach, and social mobilization. The health ministry is also promoting research for development and implementation of improved tools and strategies. ]]> <![CDATA[First green revolution technologies equally supported by policies : Dr Swaminathan]]> https://biospectrumindia.com/news/95/6403/first-green-revolution-technologies-equally-supported-by-policies-dr-swaminathan.html https://biospectrumindia.com/news/95/6403/first-green-revolution-technologies-equally-supported-by-policies-dr-swaminathan.html Mon, 19 Aug 2013 11:16:00 +0530 In his inaugural address at 'The 50 PACT' event at New Delhi on August 16, 2013, Dr M S Swaminathan highlighted the journey of Indian agriculture from catastrophic famine of Bengal during pre-independence era to the current 'Right of Food' from country grown grains. He remembered the first Green Revolution during 1960s led by technology and duly supported by public policies. "We could achieve this remarkable feat despite tremendous increase in population and several challenges," he added. Dr Swaminathan advised that there is no time to relax as per capita availability of agricultural land and water resources are shrinking. Climate change and reluctance of youth to take up agriculture are further aggravating the situation. He emphasized upon the need of evergreen revolution by mainstreaming ecology, technological development and dissemination. He also remembered and paid tribute to Dr Borlaug and said that his life and work is the message to the world. On this occasion, Dr. Swaminathan was honored by Dr Norman Borlaug Award. Dr. Thomas A. Lumpkin, Director General, CIMMYT (USA) appreciated long association of CIMMYT with India and highlighted the need to grow more food for more population from the same area of land to maintain the food security in India and the neighboring countries. He also emphasized upon to harness new technologies, such as biotechnology, precision agriculture and mobile based decision support systems to increase the production of food grains. Dr. Lumpkin hoped that association of CIMMYT with ICAR will go a long way in alleviating the hunger from the South Asian region. Ms. Jeanie Laube-Borlaug, Chairperson of Borlaug Global Rust Initiative (BGRI) and daughter of Dr. Norman Borlaug expressed her happiness on participating in this event and remembered the association of Dr. Borlaug with India and Indian farmers. She said that to advance Dr. Borlaug's legacy and vision to alleviate hunger in the most sustainable and nutritious way, my father would urge us to harness all the tools of biotechnology that we have before us. Ms. Borlaug said that her father was a frequent visitor to India and she also loves to visit this place time and again. Borlaug Institute for South Asia (BISA) will be instrumental in realizing the dreams of my father, she added. Dr. R.S. Paroda, Chairman, TAAS; Dr. M.V. Rao, Former Special Director General, ICAR and Dr. R.B Singh also gave their remarks on the occasion and narrated anecdotes of their association with Dr. Borlaug. Earlier, Dr S Ayyappan, secretary, DARE and director general, ICAR welcomed the dignitaries and briefed the gathering about the objectives of the 'The 50 PACT'. He said that this event is a gathering of conversations and existing partnerships on food security in South Asia. The two-day (16-17th August, 2013) event is being jointly organized by the ICAR, CIMMYT and Borlaug Institute for South Asia. Senior officials and scientists from CGIAR institutions, ICAR, World Bank and other national and international organization of repute are participating in this programme. Dr Swapan Kumar Datta, Deputy Director General (Crop Science), ICAR proposed vote of thanks. ]]> <![CDATA[Pall Corp., launches expanded SLS Technical Support Center ]]> https://biospectrumindia.com/news/95/1259/pall-corp-launches-expanded-sls-technical-support-center-.html https://biospectrumindia.com/news/95/1259/pall-corp-launches-expanded-sls-technical-support-center-.html Mon, 19 Aug 2013 10:22:00 +0530 Pall India Pvt. Ltd., recently inaugurated its expanded Scientific Laboratory Services (SLS) Technical Support Center in Bangalore, which now has more than 60 per cent enhanced validation and testing capacity. Established in 2006, expansion of this SLS Technical Support center further enhances Pall's capability to support the process development needs of its customers across various industries. The move also reinforces Pall Corporation's dedication to the growing bio-pharmaceutical industry in India. "Investment in this SLS Technical Support center to establish a premier filter validation facility represents a strong commitment from Pall Corporation towards solving the diverse and complex filtration and separation challenges of our customers in the South Asia region. It caters to both Life Sciences and Industrial businesses, providing our customers with advanced scientific support for their application needs. The expanded facility also houses a state-of-the-art training center," said Naresh Narasimhan, Managing Director, Pall India. The Pall India SLS Technical Support center offers customized solutions through Pall products and technologies, filtration and validation packages, and optimization of customer applications and processes. This expanded facility provides a validated clean room for microbiology, a validated lab capable of handling cytotoxic materials, a unique validated cold room to facilitate low temperature testing and houses new technologies for protein purification and characterization. Sachin Indane, Director of the Bio-pharmaceuticals division of Pall India, further emphasized, "With an increasing number of Indian pharmaceutical companies venturing into regulated markets, a need for reliable and speedy support in validation studies is eminent. We are very excited to pledge our support to the growing needs of this industry." In addition, the SLS Technical Support center is focused on providing customers with wet laboratory training using specialized resources in the fields of filtration, biotech and vaccine process development, protein purification, process characterization and optimization. Training courses are fully customizable to Pall's offering in primary separation, sterilizing filtration of liquids and gases, tangential flow filtration and ultra-filtration, chromatography, filtration validation studies and regulatory requirements, filter integrity testing and single-use systems. To celebrate the launch, Pall hosted senior industry leaders for a symposium on "Current Regulations and Inspection Trends for Filtration and Filling in Aseptic Processing", which was led by Jerold Martin, Sr. Vice President for Global Scientific Affairs, Pall Corporation. Pall Corporation (NYSE:PLL), headquartered in Port Washington, New York, USA, is a filtration, separation and purification leader providing solutions to meet the critical fluid management needs of customers across life sciences and industry. Pall Life Sciences provides products and services to meet the needs of customers discovering, developing and producing biotech drugs, vaccines and classic pharmaceuticals. ]]> <![CDATA[Eat fatty fish or leafy vegetables to avoid rheumatoid arthritis]]> https://biospectrumindia.com/news/95/5463/eat-fatty-fish-or-leafy-vegetables-to-avoid-rheumatoid-arthritis.html https://biospectrumindia.com/news/95/5463/eat-fatty-fish-or-leafy-vegetables-to-avoid-rheumatoid-arthritis.html Wed, 14 Aug 2013 12:55:59 +0530 It may be good to eat fatty fish like salmon or vegetarian equivalents like walnuts or leafy vegetables or flaxseed oil over a long period of time (10 years or more) regularly and prevent the risk of rheumatoid arthritis. This was revealed by a study of more than 32,000 women in Sweden, over three decades, reported in the journal, Annals of the Rheumatic Diseases. Scientists who conducted the study found that women who were consuming fatty fish such as salmon once a week or four servings of lean fish like cod, regularly for more than 10 years, showed 50 per cent less chances of developing rheumatoid arthritis. They believe that the beneficial effects were due to the presence of Omega 3 PUFA or Omega-fats or n-3 fats in the fish. The same Omega-e fats are also available in plenty in leafy vegetables, walnut , vegetable oils, flaxseed oils etc. The study involved review of dietary habits and data of women born between 1914 and 1948. Their dietary habits were studied at regular intervals. The final analysis was done between 2003 and 2010. Of the 205 people in the study group who developed rheumatoid arthritis, the dietary analysis revealed that 27 per cent of them had an intake of less than 0.21 gram of Omega-3 PUFA. Those who consumed more than this amount (equivalent to a weekly once serving of salmon) had less than 52 per cent risk of developing rheumatoid arthritis. ]]> <![CDATA[FDA eases norms to reduce clinical trial costs]]> https://biospectrumindia.com/news/95/5351/fda-eases-norms-to-reduce-clinical-trial-costs.html https://biospectrumindia.com/news/95/5351/fda-eases-norms-to-reduce-clinical-trial-costs.html Wed, 14 Aug 2013 12:16:00 +0530 In a move that will reduce time and cost of bringing new drugs to market, America's drug regulator, Food and Drug Administration (FDA) has introduced new clinical trial guidelines that encourages and approves more centralized, risk-based monitoring of data instead of costly and time-consuming on-site data verification. The new guidance norms, an updated versions of FDA's 2011 clinical trials guidelines, were unveiled on August 7, 2013. It is called, " Oversight of clinical investigation-a risk-based approach to monitoring." Earlier, FDA had preferred 100 per cent on-site verification clinical trials data by companies that do this work for pharma firms. The new guidance applies for all trials of drugs, biologicals and medical devices. FDA's new norms are seen as an attempt to mute widespread industry criticism of the regulator over its stringent on-site data monitoring norms that escalate the cost of trials besides adding to more development time cycles. Industry insider estimate that about 10 per cent of the costs of a new drug development is attributed to on-site verification costs. Modern drug trials take place across many continents and multiple far-flung locations. Now FDA is okay with drug sponsors taking up on-site verification of clinical trial data generated only at sites considered to be risk-prone to manipulation. For all other cases, centralized monitoring of data using various technology tools are preferred. FDA says that incorporation of centralized monitoring practices, where appropriate, should improve a sponsor's ability to ensure the quality of clinical trial data. It also says that several (research) publications suggest that certain data anomalies such as fraud, including fabrication of trial data, and other non-random data distributions may be more readily detected by centralized monitoring techniques than by on-site monitoring. It has also been suggested that a statistical approach to central monitoring can "help improve the effectiveness of on-site monitoring by prioritizing site visits and by guiding site visits with central statistical data checks." FDA had used a survey, conducted through the Clinical Trials Transformation Initiative (CTTI), a consortium of all stake holders involved in drug development, to collate the various types of monitoring undertaken during clinical trials. For major efficacy trials, companies typically conduct on-site monitoring visits approximately at 4-8 week intervals because of the perception that such visits will ensure 100 per cent compliance of trial processes. Another recent review of on-site monitoring data of a large multi-center international trial along with centralized monitoring analysis of the same data indicated that there was no appreciable differences in the findings. In fact, centralized monitoring process detected more than 90 per cent of the findings done by on-site monitoring of the clinical trial. Industry leaders are extremely happy with the changed FDA guidelines. Many, however, feel that sponsors may use the new risk-based monitoring only for Phase-2 and Phase-4 clinical trials and will continue to do on-site monitoring of critical Phase-1 and Phase-3 trials of human volunteers, where the stakes are very high. In fact, the new guidelines state that, "Supplement or reduce the frequency and extent of on-site monitoring activities that can be done as well or better remotely or with monitoring activities that can be accomplished using centralized data processes only." In recent years, Clinical Research Organizations (CROs) have started using information and database technologies in a big way to store and analyze the voluminous amount of data. With the FDA encouraging such practices in a big way, a new era of business opportunities will most likely emerge for IT companies worldwide to develop more applications, suited for centralized monitoring of clinical trial data. The report can be downloaded from the below link. http://www.biospectrumindia.com/edm/FDA%20guidance/FDA%20guidance.pdf ]]> <![CDATA[We don't moniter turnover of drug companies: Govt]]> https://biospectrumindia.com/news/95/7813/we-dont-moniter-turnover-of-drug-companies-govt.html https://biospectrumindia.com/news/95/7813/we-dont-moniter-turnover-of-drug-companies-govt.html Wed, 14 Aug 2013 11:45:00 +0530 According to the information revealed by the minister of sate for chemicals and fertilisers, Srikant Kumar Jena in the parliament on August 13, 2013, "The drug manufacturing license is given by the State Drug Controller and the Department of Pharmaceuticals (DoP) does not monitor this data. As per the Foreign Trade Policy most of the drugs are freely imported. The import license is given by the Drug Controller General of India(DCGI) and this department does not monitor this data." "No inter ministerial committee was formed as per the recommendations of the 45th report of parliamentary standing committee on health. However, a high powered inter-ministerial coordination committee formed by the DoP under the chairmanship of secretary, pharmaceuticals to look into the matters of implementation of government commitment to provide quality medicines at affordable prices has finalized its recommendations," explained the minister. Taking about the action taken, Jena said, "The various recommendations of the committee pertaining to the pricing and quality aspects of medicines have been referred to the concerned ministries/departments/organizations for taking necessary action." ]]> <![CDATA[Agriculture ministry: GM crops approval only on case to case basis ]]> https://biospectrumindia.com/news/95/8148/agriculture-ministry-gm-crops-approval-only-on-case-to-case-basis-.html https://biospectrumindia.com/news/95/8148/agriculture-ministry-gm-crops-approval-only-on-case-to-case-basis-.html Wed, 14 Aug 2013 07:54:00 +0530 "The government of India is following a policy of case by case approval of genetically modified (GM) crops. The extensive evaluation and regulatory approval process takes place before any GM crop is approved for commercial cultivation. This includes generation of relevant biosafety information, its elaborate analysis to ensure food, feed and environmental safety. A final view on the commercialization of GM crop plants is taken only when there is a clear economic and technical justification besides suitability for environment and human consumption." This was stated by Tariq Anwar, minister of state for agriculture and food processing industries in the Lok Sabha on August 13, 2013. Giving the example of Bt cotton, Tariq explained further, "Bt Cotton is the only Genetically Modified (GM) crop that has been introduced for commercial cultivation in the country.Since its inception, there have been objections from some of the Non-Governmental Organizations besides Civil Society on Agriculture, etc., on the grounds that (i) Biosafety assessment of Bt Cotton before its introduction and post release monitoring of Bt cotton is not adequate; (ii) Bt cotton is not suitable for cultivation in rainfed areas, (iii) Cattle death and farmers' suicides have been attributed to introduction of Bt cotton in some regions such as Warangal and Vidarbha." The minister also said that objections have been very speculative, without any reasonable assessment of the technological strengths of Bt-cotton. "In spite of the controversy regarding Bt cotton, the ground reality is that during the last decade, area under cotton cultivation (approx. 12 million hectares, of which 90% is under Bt cotton) and productivity of cotton has gone up significantly. During the post Bt cotton era, Indian economy has benefited as India is the second largest exporter of cotton. There is no scientific evidence to show that Bt cotton has adversely impacted the biodiversity or human/cattle health," he explained. Adding further on the objectives behind the introduction of BT cotton, he said, "The main purpose of Bt cotton was to control bollworms to enhance yield and production of cotton in the country. Bt cotton effectively control bollwsorms, especially Helicoverpa armigera, thus preventing yield losses from an estimated damage of 30% to 60% each year in India. The biggest gain from the technology is in the form of reduced insecticide usage for bollworm control. Yields are estimated to have increased at least by 30% due to effective protection from bollworm damage." ]]> <![CDATA[Glenmark receives final ANDA approval]]> https://biospectrumindia.com/news/95/3359/glenmark-receives-final-anda-approval.html https://biospectrumindia.com/news/95/3359/glenmark-receives-final-anda-approval.html Tue, 13 Aug 2013 14:01:49 +0530 Clenmark Generics Inc., USA the subsidiary of Glenmark Generics Ltd has been granted final abbreviated new drug approval (ANDA) from the United States Food and Drug Administration (U.S. FDA) for Acamprostrate Calcium Delayed Release Tablets its generic version of forest Laboratories' Campral Delayed release Tablets. Acamprostrate is indicated for the maintenance of abstinence from alcohol dependence. Based on IMS Health sales data for the last 12 month period ending on march 2013, Acamprosate garnered sales of USD 21 million. In addition to these internal filings, GGI continues to identify and explore external development partnership to supplement and accelerate the growth of the existing pipeline and portfolio. ]]> <![CDATA[Sun Pharma reports strong quarter ]]> https://biospectrumindia.com/reports-white-papers/95/3555/sun-pharma-reports-strong-quarter-.html https://biospectrumindia.com/reports-white-papers/95/3555/sun-pharma-reports-strong-quarter-.html Tue, 13 Aug 2013 14:01:09 +0530 Sun Pharmaceutical Industries Ltd. reported financials for the first quarter ending June, 2013. Dilip Shanghvi, Managing Director of the Company said, "All our businesses continue to perform in-line with our expectations.We remain focused on strengthening our existing businesses and developing a differentiated and speciality driven product basket. We also continue to review opportunities to expand and strengthen our global footprint." Highlights of Q1FY14 consolidated financials: - Branded generic sales in India, at Rs. 849 crores, grew by 44% over Q1 last year. Adjusted sales growth of the domestic formulation business. - US finished dosages sale is US$ 364 million recording a growth of 28% over Q1 last year. - International formulation sales is US$ 81 milion and grew by 19% over same quarter last year. - EBITDA at Rs. 1531 crores grew by 26% YoY while EBITDA margins were at 44%, compared to 46% in Q1 last year. - Recurring Net profit at rs 1241 crores witnessed a growth of 56% over Q1 last year; resulting margin of 36% - Reported net loss at rs. 1276 crores, on account of a provision of rs 2517 crores towards patent infringement litigation related to generic versions of 'Protonix'. Taro posted over all sales of US$ 153 million for Q1 FY14, a decline of 4% from the corresponding quarter last year. Excluding the one time charge related to price adjustments on contractual obligations, sales would have been higher by 10%. Taro's net profit for Q1 was US$ 59 million. ]]> <![CDATA[Biocon offers four targeted therapies in cancer treatment]]> https://biospectrumindia.com/interviews/95/3375/biocon-offers-four-targeted-therapies-in-cancer-treatment.html https://biospectrumindia.com/interviews/95/3375/biocon-offers-four-targeted-therapies-in-cancer-treatment.html Tue, 13 Aug 2013 12:06:00 +0530 The annual incidence of all forms of cancer is about a million in India with lung, head, neck and breast comprising the leading sites. Accelerating incidence is due to increasing life expectancy,sedentary lifestyles and risk factors like smoking coupled with greater access to early and efficient diagnosis. Biocon is one of the few Indian companies to offer four targeted therapies in a short span of time. The success of its flagship brands, BIOMAb EGFR® and AbraxaneTM has placed Biocon among the top 10 oncology players in India. In addition, it has a wide portfolio of supportive care and cytotoxic drugs, at very affordable rates. According to Mr Shukrit Chimote, head, branded formulations-India, Biocon, "Though compulsory licensing has made some novel drugs significantly affordable, I feel it might deter launches of innovative medicines in India.Biocon's oncology business development team is one of the most active in the industry. We are constantly on the lookout for exciting and affordable treatment options for Indian cancer patients" Mr Chimote revealed further, "We are in the process of launching a modality for treating CT/RT induced oral mucositis, a new treatment option RT induced dermatitis amongst few other launches. Clinical evaluation of several drugs from our Biologics pipeline is in advanced stage." Biocon launched BIOMAb EGFR® (Nimotuzumab), the first novel biologic from its R&D pipeline, in 2006. It is a humanized anti-EGFR MAb approved in India for the treatment of head and neck cancers. Cost of BIOMAb EGFR® treatment is at least 50% lower than other comparable treatment options. So far, over 5,500 patients have been treated with BIOMAb EGFR® with complete support to over 1,500 underprivileged patients through our compassionate use program. With several promising indications such as oesophageal cancer, cervical cancer, lung cancer, etc, Biocon is currently conducting several clinical trials at various centers in India. In collaboration with the HCG Group of Hospitals, Biocon is conducting an Investigator Initiated Trial to study the effects of Nimotuzumab in 110 cervical cancer patients. A robust Post Marketing Surveillance study of BIOMAb EGFR® is in progress at the Tata Memorial Hospital with over 530 head & neck cancer patients. In addition, four large scale Phase III international trials (two in head and neck cancer, one in lung cancer and one in gastric cancer) are ongoing to establish Nimotuzumab's 'best-in-class' status for the treatment of various cancers. Abraxane, based on cutting edge nanotechnology has benefitted over 5000 patients so far since it was launched in 2008. We expect the brand to continue to do well with approval for non-small cell lung cancer by USFDA and pancreatic cancer being a promising new indication. ]]> <![CDATA[Jubilant Biosys announces successful filing of IND with US-based Endo Pharmaceuticals]]> https://biospectrumindia.com/news/95/3379/jubilant-biosys-announces-successful-filing-of-ind-with-us-based-endo-pharmaceuticals.html https://biospectrumindia.com/news/95/3379/jubilant-biosys-announces-successful-filing-of-ind-with-us-based-endo-pharmaceuticals.html Tue, 13 Aug 2013 11:45:00 +0530 Jubilant Biosys Ltd., a Bengaluru-based subsidiary of Jubilant Life Sciences Ltd., recently announced the US FDA acceptance of the Investigational New Drug (IND) filing for a novel molecule targeting prostate cancer with Endo Pharmaceuticals in the US. This molecule will now progress towards the next phase of development and is anticipated to go into clinical trials by late 2013. "We are very pleased and elated with this successful outcome, which is the result of excellent collaboration between the scientists at Endo and Jubilant Biosys. Being at the forefront in pharmaceuticals, life sciences and healthcare innovation, Jubilant pursues its goal to enable affordable healthcare to patients worldwide," said Dr SubirKumar Basak, president, Global Drug Discovery Services, Jubilant Life Sciences. Added Dr Sandeep Gupta, senior vice president, Discovery & Early Development, Endo Pharmaceuticals, "I congratulate the Jubilant and Endo teams on achieving this important milestone. It was their outstanding collaborative work and ingenuity that enabled the successful filing and acceptance of an IND in less than three years. The IND filing and progression of the molecule to the next stage of development further validates Endo's unique collaborative drug discovery approach which aims to address unmet medical needs and improve patient outcomes." The multi-target oncology collaboration between Jubilant and Endo began four years ago, and is focused on developing best-in-class, differentiated therapies that address the unmet needs of cancer patients worldwide. The collaboration has delivered on multiple milestones across the discovery continuum. Jubilant Biosys Ltd. is a Bengaluru-based subsidiary of Jubilant Life Sciences Ltd., which is headquartered in Noida, India. It provides integrated drug discovery solutions to the global pharmaceutical industry. ]]> <![CDATA[Suven Life secures product patents for their NCEs in Europe]]> https://biospectrumindia.com/news/95/5887/suven-life-secures-product-patents-for-their-nces-in-europe.html https://biospectrumindia.com/news/95/5887/suven-life-secures-product-patents-for-their-nces-in-europe.html Tue, 13 Aug 2013 11:24:05 +0530 Suven Life Sciences Ltd (Suven), Hyderabad, recently announced the grant of two (2) product patents from Europe (1567492 and 2346847), corresponding to the New Chemical Entities (NCEs) for the treatment of disorders associated with Neurodegenerative diseases. These Patents are valid through 2023 and 2029 respectively. The granted claims of the patents include the class of selective 5-HT compounds discovered by Suven and were developed as therapeutic agents and are useful in the treatment of cognitive impairment associated with Neurodegenerative disorders like Alzheimer's disease, Attention Deficient Hyperactivity Disorder (ADHD), Huntington's disease, Parkinson's disease and Schizophrenia. With these new patents, Suven has a total of thirteen (13) granted patents from Europe. These granted patents is said to be an exclusive intellectual property of Suven and were achieved through the internal discovery research efforts. Products out of these inventions may be out-licensed at various phases of clinical development like at Phase-I or Phase-II. "We are very pleased by the grant of these patents to Suven for our pipeline of molecules in CNS (Central Nervous System) arena that are being developed for cognitive disorders with high unmet medical need with huge market potential globally," says Venkat Jasti, CEO of Suven. Suven Life Science is a biopharmaceutical company focused on discovering, developing and commercializing novel pharmaceutical products, which are first in class or best in class CNS therapies through the use of GPCR (G-protein-coupled receptors) targets. The Company has twelve (12) internally-discovered therapeutic drug candidates, currently in the pre-clinical stage of development targeting conditions, such as ADHD, dementia, depression, Huntington's disease, Parkinson's disease and obesity in addition to developmental candidate SUVN-502 for Alzheimer's disease and Schizophrenia. ]]> <![CDATA[First NABH Accredited Hospital in Goa: Wockhardt]]> https://biospectrumindia.com/news/95/7481/first-nabh-accredited-hospital-in-goa-wockhardt.html https://biospectrumindia.com/news/95/7481/first-nabh-accredited-hospital-in-goa-wockhardt.html Mon, 12 Aug 2013 16:31:17 +0530 Wockhardt hospitals Ltd. today, announced that the Wockhardt Hospital, goa has received accreditation from National Accreditation Board for hospitals and Healthcare Providers (NABH), the highest national recognition and a mark of quality patient care and safety. Ms. Zahabiya Khorakiwala, MD, Wockhardt Hospitals commented on this achievement, "We are proud that our Goa has been accredited by NABH. We are continuously striving hard towards providing the best of services to our patients, enabling the benefits of the latest technological development in the field of medicine.This accreditation strengthens our commitment to fullfil the needs of the community and provide patients care." Dr KK Kalra, CEO, NABH spoke on the benefits of accreditation to the patients, society as well as medical community. He expressed "It was a moment of pride for NABH also to be awarding the first accreditation to Goa, which is the 15th state in the country to have an accredited hospital. It is the continuous efforts of the Quality Council of India and NABH to ensure quality of care tye patients avail at a hospital." ]]> <![CDATA[CSIR signs MOU on chemoinformatics]]> https://biospectrumindia.com/news/95/3356/csir-signs-mou-on-chemoinformatics.html https://biospectrumindia.com/news/95/3356/csir-signs-mou-on-chemoinformatics.html Mon, 12 Aug 2013 15:46:00 +0530 The memorandum of understanding (MoU) signed between CSIR and the United Kingdom based Royal Society of Chemistry, is meant to build a community of researchers in India on cheminformatics, which will support drug discovery efforts of OSDD for Tuberculosis (TB), Malaria and other neglected diseases that predominantly affect India. Cheminformatics is an emerging discipline that supports drug discovery. The MoU contemplates scientific partnership through activities such as building an online repository of real and virtual molecules, jointly developing free, cutting edge level software tools, etc. OSDD is focused on drug discovery with TB as the first target disease, and has taken up Malaria as an additional target for the 12th plan. Research collaboration in cheminformatics is expected to help OSDD's drug discovery efforts on TB and Malaria. Drug discovery is a long and risk prone endeavour with gestation period of 12-15 years. Therefore it is difficult to fix timelines of delivery particularly considering the fact that many established pharmaceutical companies have failed in their effort to find new drugs for TB for the past forty years. Since TB and Malaria are diseases that are of serious national concern, CSIR through the OSDD programme is making a concerted effort to discover new drugs for the benefit of TB and Malaria patients particularly on patients with drug resistant infections. These drugs will be made available at affordable costs. OSDD has shown promising results in its short span of five years of existence. ]]> <![CDATA[Three hectare biotech park coming up in Uttar Pradesh]]> https://biospectrumindia.com/news/95/5803/three-hectare-biotech-park-coming-up-in-uttar-pradesh.html https://biospectrumindia.com/news/95/5803/three-hectare-biotech-park-coming-up-in-uttar-pradesh.html Mon, 12 Aug 2013 13:45:00 +0530 The proposed park that is reported to have been given green signal by Uttar Prdesh government, is expected to be constructed on an area of three hectares by the state science and technology department. The chief minister is likely to lay the foundation stone of the proposed park during August. The park will also be linked to the already existing biotechnology park in Lucknow and other scientific institutions. The district administration is said to have identified the land in Waisapur village situated on the Etawah-Kannauj road. The thrust of the biotechnology park will to improve the quality and yield of crops, horticulture and forest tree species, bio-pesticides, bio-fertilizers and processed foods. It will include state-of-the-art laboratories where banana saplings will be developed based on tissue culture technique. Production of bio-fertilizers (which are cost-effective than the chemical fertilizers), Rhizobium, Blue Green Algae, Azatobacter, among other things, will be developed and provided at subsidised rates to farmers. The aim is to reduce the dependence of farmers on chemical fertilizers. Since Kannauj is a major centre for the perfume industry, latest technology will be implemented after undergoing trials at a perfume centre in the biotechnology park. New techniques for developing high-yielding varieties of potato, which is a major cash crop in the area, through tissue culture will also be developed. Centres for floriculture will also be developed as cultivation of flowers is fast picking up in the area. Facility for a glass house to protect and maintain the plants in temperate climate and later multiplying them in large scale during off season will also be provided at the proposed park. ]]> <![CDATA[Biocon's novel anti-psoriasis biotech drug released in India]]> https://biospectrumindia.com/news/95/8199/biocons-novel-anti-psoriasis-biotech-drug-released-in-india.html https://biospectrumindia.com/news/95/8199/biocons-novel-anti-psoriasis-biotech-drug-released-in-india.html Sat, 10 Aug 2013 20:10:00 +0530 After geting the regulatory approval in early 2013, Biocon, India's No.2 biotech company by revenues, has released the much awaited Itolizumab with the brand name Alzumab in India on August 9. The monocolonal anti-body, the second novel biological drug developed entirely in India, s an anti-CD6 antibody based product. " Biocon's Alzumab is the first anti-CD6 monoclonal antibody to be commercialized, an outcome of path breaking research in India," said Biocon's CMD, Kiran Mazumdar-Shaw while launching the product in Bangalore on Saturday( August 10). " We are proud that this will be the first instance of a breakthrough innovation from India with a potential to treat multiple autoimmune diseases and making a difference to a much larger patient population across the world." A vial of the injectible medicine ( 25 mg/5 ml) will cost Rs 7,950( $131) compared to four other multinational products currently available in the Indian market at more than double this price. A patient has to take 28 injections and 12 maintenance shots every alternate weeks over 24 weeks. The approximate cost of treatment will be Rs 3.2 L ( $ 5,243). More than the cost, Alzumab is believed to be better than the existing biological products such an Enbrel( Pfizer), Humira (Abbott), Remicade etc because studies indicate that there are no appreciable side-effects. On the other hand, other drugs are known to reduce immunity and increase the incidence of tuberculosis in many patients. These are a class of anti-immune drugs which treat all such diseases.Biocon started work on this drug more than 10 years ago, said Mazumdar-Shaw and the drug went through one of the largest clinical trials for a biological drug in the country. More than 400 patients in the age group of 18 to 65 were enrolled for the trials. She said patients with Alzumab showed remission only after 24 weeks compared to 5-20 weeks in the case of existing drugs. A woman patient enrolled in the trial showed 97 per cent improvement after 8 weeks of treatment and no relapse occurred even after six months. There are about 100 autoimmune diseases like psoriasis that affect humans. Other prominent auto-immune diseases are multiple scelorsis, rheumatoid arthritis, lupus. Drugs have been developed only to treat about 10 diseases so far. Approximately 1-2 per cent of population in USA and Europe suffers from psoriasis. In India also, it is estimated that about 2 per cent or 12-24 million are affected by psoriasis.Mazumdar-Shaw said Biocon started working on this drug 10 years ago on a Th1 path way but serendipitously arrived at the Th17 pathway few years ago when the results were very encouraging. Current treatments include a regiment of conventional immunosuppressants in most people and only a very minuscule section of patients in India and abroad are treated using biological drugs due to high costs. Mazumdar-Shaw said Alzumab prices could come down if more patients start using it and efforts were on to make it widely available by educating doctors and the medical community about the effectiveness of Alzumab. Many patient access programmes will be developed in cooperation with patient advocacy groups. Biocon officials are hopeful that the entry of an affordable version of the anti-psoriasis drug will lead to market creation and ensure more patients start using it. Currently, due to high prices most of the patients discontinue treatment of biological drugs mid-course . Biocon hopes that a few thousand patients will benefit from their affordable drug in a year. Mazumdar-Shaw said the company will soon be filing an IND( investigational new drug) application with the US regulator FDA along with a partner company for making the drug available in the US. Talks were on to identify suitable partners. She was hopeful that due to the high quality of the clinical data generated in India, it may be possible to shorten the process in the US. Alzumab is the second novel biological drug developed by Biocon. In 2006, Biocon released BIOMab EGFR, a monoclonal anti-body to treat head and neck cancers. More than 20,000 patients in 27 countries have benefited from the drug so far. By N Suresh and Raj Gunashekar ]]> <![CDATA[CIFT develops two new products ]]> https://biospectrumindia.com/news/95/3361/cift-develops-two-new-products-.html https://biospectrumindia.com/news/95/3361/cift-develops-two-new-products-.html Thu, 08 Aug 2013 14:46:00 +0530 The Mumbai Research Centre of CIFT developed a novel method for preparing hydroxyapatite (HAP) crystals from fresh water fish scales. Hydroxyapatite and calcium phosphate based biomaterials attracted considerable interest in the field of tissue engineering. The main areas of application of HAP are orthopedics and orthodontics, where bone tissue has to be replaced, partially or totally. HAP is identified as an ideal raw material for the development of artificial bone implants and bone filling material. The other product developed by CIFT is Fish Calcium Capsules. Fish discards like bones and scales are important sources of Calcium which has several important functions in human body. The Fish Processing Division of CIFT developed and standardized a low cost method for the extraction of calcium from fish bones. Calcium is extracted from rohu bone by removing protein and fat and encapsulated with supplemented vitamin D. In vivo studies conducted at CIFT in albino rats have shown that fish calcium powder supplemented with vitamin D has improved the absorption and bioavailability. This product from fish bone is a viable and affordable option for dietary calcium supplementation, particularly for the women and aged. ]]> <![CDATA[DBT looks at developing industrial products from Seabuckthorn]]> https://biospectrumindia.com/news/95/3373/dbt-looks-at-developing-industrial-products-from-seabuckthorn.html https://biospectrumindia.com/news/95/3373/dbt-looks-at-developing-industrial-products-from-seabuckthorn.html Thu, 08 Aug 2013 13:38:00 +0530 The department of biotechnology (DBT), ministry of science and technology had in past supported a major network program on germplasm collection and characterization of Seabuckthorn. During this program, several hundred accessions have been characterized at various participating institutes. Considering the industrial importance of this bioresource, department is now looking at developing a network program to take this work forward aimed at developing industrial products through prospecting of bioactive molecules from Seabuckthorn. The objective is to establish a network programme involving R&D centres at universities and Institutes who are interested in Prospecting of Seabuckthorn for Industrial important bio-molecules. Specific emphasis on should be to work with standardized extracts in order to develop herbal products. The full length proposals are invited from R&D centres (national laboratories, public institutes, universities etc) who are interested in prospecting on Seabuckthorn of industrial importance. The agency will prefer mostly network proposals. Prospecting on Seabuckthorn for industrial important bio-molecules for- therapeutic herbal products such as antimicrobial, wound healing, anti-ulcer, and cardiovascular; cosmeceutical products such as anti-ageing creams, foot crack creams, and facial creams; nutraceutical products such as health tonics. As per the notification by DBT, in case there is interest in developing a product which has not been listed, that could also be considered, however proper justifications should be provided regarding its national relevance/market potential. The proposals must highlight novelty and strength of existing knowledge, demonstrated proof of concept and expected products/outcomes. If industry is involved, IP sharing between the partners should be clearly spelt out and the percent budget contribution of the industrial partner should be mentioned clearly. The proposals will be examined by constituted expert committee and those which get shortlisted will be intimated for presentation for consideration of financial support by DBT. Interested Scientists working in the universities, national laboratories and public institutes can submit their proposal Online DBT eproMIS website (http://dbtepromis.nic.in/login.aspx) under the Programme Area "National Bio-resource Development Board-Bioprospecting" latest by August 31, 2013. ]]> <![CDATA[C-Section babies have less immunity]]> https://biospectrumindia.com/news/95/3371/c-section-babies-have-less-immunity.html https://biospectrumindia.com/news/95/3371/c-section-babies-have-less-immunity.html Thu, 08 Aug 2013 11:53:00 +0530 British Princess Kathrine Middleton did well to deliver the future king, Prince George Louis in July in the normal way instead of opting for the easier caesarean way to save time and effort. For, a latest scientific study shows that children born through c-section are more vulnerable to a wide range of illnesses due to the absence of a beneficial group of bacteria in their guts. A study of 24 infants revealed that the ones born through the vaginal canal route had the abundance of Bacteroidetes phylum, a beneficial group of bacteria that triggers immune responses and a set of chemicals that fight allergies in newly borns. Babies born through c-section lack these in the first two years and they will be prone to diseases due to lack of developed immunity, according to a study reported by the British Medical Journal quoting a study in another scientific magazine, Gut. This means that pharmaceutical companies should aim to develop products that enhance immunity in millions of children born through c-section in the first two years of their life and increase their chances of survival. Scientist said they studies mothers who delivered babies through both the methods. During c-section mothers are given strong doses of antibiotics to suppress various infection. But this was not the reason for the absence of beneficial bacteria colonies in c-section babies . Because same levels of beneficial bacteria were reported in both sets of mother prior to delivery. So it is surmised that babies acquire the beneficial bacteria colonies while passing through the vaginal canal during normal delivery and this does not happen during c-section. Same is the case with two sets of beneficial chemicals, Th1 and Th2 in the blood which are known to trigger immune responses in human body and organizes protection against many allergies early in human life. Babies delivered through c-section start acquiring collections of beneficial bacteria in their guts after 12 months and get their full range by the age of two.The C-section infants had lower circulating levels of Th1 chemical messengers in their blood, indicating an imbalance between Th1 and Th2. "Failure of Th2 silencing during maturation of the immune system may underlie development of Th2-mediated allergic disease," write the authors who are Swedish scientists, , Dr Anders Andersson, at KTH Royal Institute of Technology, Solna Sweden and . Prof Lars. Engstrad at the Karolinska Institute, Stockholm, Sweden. They point out that previous research has indicated that Bacteroides fragilis, one of the many Bacteroidetes, strongly influences the immune system, which ultimately enhances T cell activity and the Th1-Th2 balance."Thus, the lower abundance of Bacteroides among the C-section infants may be a contributing factor to the observed differences in the Th1-associated chemokines," they wrote. ]]> <![CDATA[ China reports world's first human to human bird flu virus transmission]]> https://biospectrumindia.com/news/95/7241/-china-reports-worlds-first-human-to-human-bird-flu-virus-transmission.html https://biospectrumindia.com/news/95/7241/-china-reports-worlds-first-human-to-human-bird-flu-virus-transmission.html Thu, 08 Aug 2013 11:31:00 +0530 In the first such case reported worldwide, a Chinese father is suspected to have transmitted the novel avian influenza A (H7N9) virus to his daughter who had tended to him during the illness in early March 2013. Both the father and daughter died due to the infection in the next two months. Though alarming, scientists conclude that the human-to-human transmission process has not been found to be very efficient as it had spared nearly two dozen close relatives who too had been in the proximity of the infected man during the same period, reported a study published by the British Medical Journal. The study, reported by two British scientists, Dr James Rudge and Dr Richard Coker of London School of Hygiene and Tropical Medicine is based on the epidemiological work done on the spot led by Dr Ming-Hao Zhou, director of Jiangsu Province Centre for Disease Control and Prevention, Nanjing, Jiangsu and her team. Interestingly, the daughter who provided unprotected care to her father who is suspected to have picked up the infection at the local poultry market was the first one to succumb to the virus. Her 60-year-old father died three weeks after her due to multiple organ failure induced by the virus. The daughter had never gone to the poultry market nor had she been in touch with them in all her life. This was the reason for scientists to suspect that the virus transmission took place from human to human ( father to daughter) is one of the world's first such cases reported so far. The virus isolated from both these victims were genetically identical, confirming the transmission. Scientists had checked all the poultry, swans and other water birds in the vicinity to reconfirm the source of the infected virus. "To our best knowledge, this is the first report of probable transmissibility of the novel virus person to person with detailed epidemiological, clinical, and virological data. Our findings reinforce that the novel virus possesses the potential for pandemic spread," the scientists wrote in BMJ. The new strain of avian flu virus was detected in China in early 2013 and has so far infected 133 people and 43 deaths till the end of June. The authors of the report however caution that " limited transmission between humans is not surprising but does not necessarily indicate that the virus is on course to develop sustained transmission among humans." Dr Zhou said the " virus transmission was limited and non-sustainable as there has been no outbreak of the disease in the locality after these cases." ]]> <![CDATA[First of its kind evaluation test for the biotech industry]]> https://biospectrumindia.com/news/95/5784/first-of-its-kind-evaluation-test-for-the-biotech-industry.html https://biospectrumindia.com/news/95/5784/first-of-its-kind-evaluation-test-for-the-biotech-industry.html Wed, 07 Aug 2013 18:55:00 +0530 In its endeavor to meet the requirement of the biotechnology sector, the Association of Biotechnology Led Enterprises (ABLE) along with Aspiring Minds launched AMCAT ABLE Life Sciences Certification program, an online testing tool to evaluate the employability quotient of students aspiring to work for the Biotech industry. With the aim of bringing up an inclusive employability platform for the Indian youth, this platform assesses the aspirant's language, cognitive, personality and functional skills important for the Biotech industry. AMCAT ABLE Life Sciences Certification test shall be conducted by Aspiring Minds on the premises of colleges offering graduate and post-graduate courses in science, pharmacy and bio technology. Also, Aspiring Minds' 60+ centers across India will offer the certification to aspirants. AMCAT is India's Largest Employability Test catering to the IT, ITeS, BFSI, Retail, Hospitality and Manufacturing Industry. This association with a reputed body like ABLE shall help extend AMCAT's success to the BioTech industry as well. Human resources constitute an increasingly critical function in any biotechnology company. Whatever the changing fortunes of the biotechnology industry are, successful management of human resources is essential. The Indian biotech industry is facing a scarce talent pool and ABLE is in the process of bridging this gap through various methods. "The Indian biotechnology sector is one of the fastest growing knowledge-based sectors in India and is expected to play a key role in shaping India's rapidly developing economy. With numerous comparative advantages in terms of research and development (R&D) facilities, knowledge, skills, and cost effectiveness, the biotechnology industry in India has immense potential to emerge as a global key player. This evaluation test is a first of its kind program in the biotechnology sector and ABLE is proud to announce this initiative as part of its commitment towards improving biotechnology landscape in India," said Dr PM Murali, President - Association of Biotechnology Led Enterprise (ABLE). The biotechnology education industry is a relatively young industry with lack of awareness of industry needs. The academic spectrum is wide with tens of thousands of students being trained in several life science courses each year. However, lack of awareness and educated guidance is coming in the path of employability of these students. National level certifications can help in this regard by enabling awareness and access to a certified pool to the industry. There is a huge need of standardized automated assessments to be built and deployed in the industry. According to Himanshu Aggarwal, CEO - Aspiring Minds, "We assess students on their employability across India through our flagship test, AMCAT. AMCAT ABLE Life Sciences Certification shall extend that platform and aid in showcasing Employable Talent to the industry for different roles and functions. AMCAT's comprehensive Employability Report shall go a long way in helping Biotech aspirants understand their strengths and areas of improvements in their quest to work for the booming Biotech industry in India." Kiran Mazumdar Shaw, CMD - Biocon, congratulated ABLE & Aspiring Minds and said: "The biotechnology sector in India has the potential to address several challenges faced by our country. Currently at US$ 5 billion, the Indian biotech sector is expected to grow to US$ 100 billion by 2025. However this transformation to a bio-economy can be enabled only through good quality talent and AMCAT ABLE Life Sciences certification program is expected to develop 'industry ready' biotech professionals who can partake in this exciting journey. I am sure the industry will benefit with the new initiative as it will improve access to employable biotech professionals." ABLE along with government agencies and others have launched several initiatives over the past years to assist in eliminating the gap between industry, academia and Government, which is hampering the growth of the industry. ABLE has begun nurturing young entrepreneurs through NEST and BEST programmes for students, in collaboration with the Department of Biotechnology, which is yielding good results. ]]> <![CDATA[Food distribution requires attention not FS bill: Dr Balasubramanian]]> https://biospectrumindia.com/news/95/3360/food-distribution-requires-attention-not-fs-bill-dr-balasubramanian.html https://biospectrumindia.com/news/95/3360/food-distribution-requires-attention-not-fs-bill-dr-balasubramanian.html Wed, 07 Aug 2013 12:17:00 +0530 Q What is your opinion on food security bill that is said to critical for reaching out to deprived sections and ensuring food for all? ? What will be its impact on agriculture system? The very idea of this populist measure looks gloomy. One can figure out well that the government is desperately trying to treat for the superficial symptoms while conveniently forgetting to stem the rot lying within. The food is plenty in this country and only its distribution is afflicted by bureaucracy. The government cannot find fault with the bureaucracy (as the bureaucracy is government by itself) and hence has decided to cover up the symptoms. The lack of coordination between the state and the federal governments on this score adds insult to the injury. As far as impact on the agricultural system is concerned, a Pakistani woman economist has aptly said that the agricultural prices are kept low by the successive governments only to provide a cheap labour force to the industry. Without the right price, why farmers should go in for producing more and more of it. Q How do you think Indian biotechnology company will play a part in implementation of FSB? How many food crops which came to fruition through biotech research have been permitted by this government? As long as our food policy is going to be decided only by the external forces and not by the pressing needs of the masses, the Indian biotech industry whose hands remain tied cannot deliver the goods. Q Can Indian agriculture biotechnology companies/industry play a part in making its implementation a success? I repeat the quote by the Pakistani scientist as an answer for this query. Agriculture has never received its due share from the successive governments. Bioscientific methods have a lot to contribute in terms of yield and quality (The best example is Bt cotton) only when the vested interests like Green Forces are going to be kept away. ]]> <![CDATA[New drug combinations offer better efficacy : Dr Manu Jaggi ]]> https://biospectrumindia.com/interviews/95/6704/new-drug-combinations-offer-better-efficacy-dr-manu-jaggi-.html https://biospectrumindia.com/interviews/95/6704/new-drug-combinations-offer-better-efficacy-dr-manu-jaggi-.html Tue, 06 Aug 2013 14:49:00 +0530 Q: What kind of growth are you expecting in the oncology market? Which are the factors that are expected to propel the same? The Indian oncology market is forecast to grow strongly in the next decade, driven by the rise in cancer incidence and diagnosis, improved access to cancer therapies, better health insurance coverage, and higher pharmaceutical spending, particularly among the growing middle class. Since cancer is the second largest cause of death in the country, the Indian market is characterized by a huge demand for cancer drugs. It is a highly fragmented market with a large number of foreign and domestic players. The Indian Government, on its part is taking initiatives to work out public-private partnership projects (PPP) and reduce the essential drug prices. The increase in government expenditure on health and improved access to cancer drugs will also drive the uptake of cancer therapeutics in the future. Q: Will the biologics and targeted therapy as predicted really grow faster than chemotherapy? What are the latest trends in these two areas? The global cancer market is going to be driven by the biologics. These drugs that are now appearing on the market are just the first wave of new anti-cancer therapies. The repertoire will expand rapidly over the next five years as more targets are identified. Some of the newest and most promising areas of cancer treatment are biologic therapies and other so-called "targeted" therapies. Since cancer cells divide and grow at an abnormal rate, biological therapy focuses on blocking the signal that tells the cancer cells to grow. Another feature of cancer cells is that they often override apoptosis and become "immortal." Targeted therapies can tell the cancer cells to undergo apoptosis. Targeted therapies can also make the cancer cells more recognizable to our own immune system, which can then seek out and destroy the abnormal cells. However, caution must also be exerted as biologically targeted drugs are primarily cytostatic as opposed to cytotoxic, and therefore, sometimes fail as monotherapy. Next decade will see more combination therapies where biologics will be combined with chemotherapy to achieve a better response rate. Q: Which are the key challenges before the companies in the Indian oncology market? Oncology remains the single largest therapeutic area for both large pharmas and start up companies. However with drying pipelines, increasing cost of launching new drugs, and patent expiries, developing new anticancer drugs is a major challenge. With the slowing down of the introduction of new anticancer drugs in the last decade, there is a need to improve upon existing drugs with respect to their formulations. It is possible to make existing drugs safer and more effective using novel drug delivery techniques such as nanoparticles and liposomes. The new drug combinations also offer hope of better efficacy in patients. Q: Please tell us about latest developments in the area at DRF? While targeted drugs are here to stay for at least another decade, cancer stem cells and differentiated drugs hold tremendous potential for treating cancer. DRF has taken several steps to face the challenges ahead. Cancer Stem Cells: There is a growing body of evidence accumulating which suggests that cancer stem cells exist in a variety of tumors. Just as monoclonal antibodies held promise and hope for treating cancer a decade ago, a radical new cancer treatment is likely to emerge from a scientific breakthrough in the understanding of how tumors grow. The theory that a fraction of tumor cells, dubbed cancer stem cells, is responsible for the malignancy of tumors is gaining adherents among once-skeptical oncologists. DRF has spent last several months understanding the intricacies of working with human stem cells and is now geared up to initiate preclinical studies in this exciting new field that holds so much promise for treating cancer. Targeted Therapy: Ever since the first targeted therapy was developed for treating breast cancer several years ago, this treatment modality has given doctors a better way to tailor cancer treatment, especially when a target is present in some but not all tumors of a particular type. Eventually, treatments may be individualized based on the unique set of molecular targets produced by the patient's tumor. Having developed its own peptide based kinase inhibitor in the past, DRF is well versed and equipped to develop newer and safer drugs. We have several ongoing projects where new drugs are being developed that target both new as well as clinically validated targets. Differentiated Drugs & Combination Therapy: With the slowing down of the introduction of new anticancer drugs in the last decade, there is a need to improve upon existing drugs with respect to their formulations. It is possible to make existing drugs safer and more effective using novel drug delivery techniques such as nanoparticles and liposomes. New drug combinations also offer hope of better efficacy in patients. DRF has experience and knowledge in both of these areas and is currently developing new treatment options using these technologies. ]]> <![CDATA[Extended Phase I trial in US to be initiated shortly : PEL]]> https://biospectrumindia.com/news/95/6126/extended-phase-i-trial-in-us-to-be-initiated-shortly-pel.html https://biospectrumindia.com/news/95/6126/extended-phase-i-trial-in-us-to-be-initiated-shortly-pel.html Tue, 06 Aug 2013 14:06:03 +0530 Investiagational New Drug (IND) P7435 is novel, potent and highly selective, oral diacylglycerolacyltransferase 1 (DGAT1) inhibitor. "The NCE Research division of Piramal Enterprises Ltd (PEL) continues its ambitious diabetes/metabolicdisorders programme to discover and develop NCEs to fight against diseases like diabetes and lipid disorders. With P7435 we are targeting at addressing a serious need for effective and well-tolerated drugs that treat lipid disorders. Expansion of this trial will allow testing this NCE in a wider population, which is critical to the development of this drug and will provide therapeutic solutions not just to India but to the whole world" commented Dr Swati Piramal, Vice Chairperson, PEL on successful approval from USFDA. PEL has achieved the safety and tolerability of P7435 in a Phase I trial recently completed in India. This extension trial in the US will further evaluate the safety and efficacy of P7435 in on a large group of population. ]]> <![CDATA[GLP accreditation will provide an edge to Venus Remedies Limited]]> https://biospectrumindia.com/news/95/8055/glp-accreditation-will-provide-an-edge-to-venus-remedies-limited.html https://biospectrumindia.com/news/95/8055/glp-accreditation-will-provide-an-edge-to-venus-remedies-limited.html Tue, 06 Aug 2013 14:04:58 +0530 Dr. Manu Chaudhary, Joint Managing Director, Venus Remedies Ltd, and director, Research, Venus Medicine Research Centre (VMRC), termed it as a landmark achievement and commented "This Good Laboratory Practices (GLP), one of the most coveted certifications for R$D capabilities,is a significant milestone in our efforts to ensure product quality, safety, reliability and excellence while preserving and improving human life through innovation. It gives our research an international credibility, which will in turn help to expand business opportunities for the company and add to the reputation of our products and personnel." The GLP certification meets the company's strategic vision to bring to the world novel breakthroughs that cater to critical care and super-speciality segments, including anti-infective, anti-cancer, neurology, pain management and wound care. The VMRC team has brought laurels to the country by securing over 90 patents for its research products from aross the world, including countries like USA, Australia, Japan, European, Union constituents and many others. VMRC has joined the list of top 25 testing laboratories in India and eight Indian pharmaceutical compoanies to have reieved GLP approval. ]]> <![CDATA[Sanofi India takes a stride towards renewable energy]]> https://biospectrumindia.com/news/95/5894/sanofi-india-takes-a-stride-towards-renewable-energy.html https://biospectrumindia.com/news/95/5894/sanofi-india-takes-a-stride-towards-renewable-energy.html Tue, 06 Aug 2013 14:04:00 +0530 Sanfoi India Ltd has signed an agreement with India's largest wind turbine manufacturer, Suzlon Energy Ltd, for 2.1 MW offsite windmill installation, to generate renewable power for captive consumption at its Ankleshwar site. Dr. Shailesh Ayyangar, Managing Director, India and Vice-President South Asia said "We are pleased to partner with Suzlon to explore the utility f wind energy. We strongly support the use of renewable energies, and hence initiated a study in 2012 to better understand the local renewable energy market in India to identify available opportunities." "We are happy to tie up with Sanofi, which is India's leading healthcare companies. In times when the future our planet is talked about on various platforms, it is extremely encouraging to see business taking proactive steps to offset their carbon emissions." commented Mr. Tulsi Tanti, Chairman, Suzlon Group. Between its two facilities at Goa and Ankleshwar, Sanfoi has the capacity to manufacture 8.5 million tablets annually. ]]> <![CDATA[Clariant Chemicals (India) Ltd net sales grew by 14.3%]]> https://biospectrumindia.com/news/95/1387/clariant-chemicals-india-ltd-net-sales-grew-by-14-3.html https://biospectrumindia.com/news/95/1387/clariant-chemicals-india-ltd-net-sales-grew-by-14-3.html Fri, 02 Aug 2013 17:14:00 +0530 Clariant Chemicals (India) Limited's six month period ending June 30, 2013, the Net Sales grew by 14.3%, from ` 521.4 crores to ` 595.9 crores, in comparison with the corresponding period of previous year. The Profit (before exceptional items) for the same period stood at ` 35.4 crores compared to ` 44.1 crores in the previous year period. After considering the exceptional items and tax expenses, the Net Profit for the period amounted to ` 24.1 crores as against ` 30.8 crores in the previous year period. "As one of India's leading specialty chemicals businesses, we are committed to sustainable and innovative growth in India. Our clear priorities for the fiscal year are to add value with competitive and innovative solutions while simultaneously controlling costs," said Dr. Deepak Parikh, VC&MD, Clariant Chemicals (India) Ltd. The Net Profit after tax for the period amounted to ` 48.9 crores as compared to ` 62.5 crores in the previous year period. The Board of Directors of the company has considered the payment of an Interim Dividend of ` 10/- (100 %) per share for the year 2013. ]]> <![CDATA[Total API product pipeline of 237 filings across regions: Jubliant Life Sciences]]> https://biospectrumindia.com/reports-white-papers/95/8165/total-api-product-pipeline-of-237-filings-across-regions-jubliant-life-sciences.html https://biospectrumindia.com/reports-white-papers/95/8165/total-api-product-pipeline-of-237-filings-across-regions-jubliant-life-sciences.html Fri, 02 Aug 2013 17:10:59 +0530 Jubliant Life Sciences Ltd, an integrated pharmaceutical and life science company approved Financial results for the quarter ended June, 2013. Mr. Shyam S Bhartia, Chairman & Managing Director and Mr. Hari S Bhartia, Co-Chairman & Managing Director, Jubilant Life Sciences said,"We are witnessing a strong underlying momentum in the life science ingredients space, where volume growth has maintained course. On the other hand the pharmaceuticals segment is delivering with strong growth in APIs. Further they added " We expect strong operational performance in pharmaceuticals due to new product launches and geographic expansion and higher capacity utilisation in Nutrition ingredients and proprietary products with the uptrend in pricing." Q1 FY14 Highlights: - Revenue growth was driven by volume growth in both segments but prices remained under pressure for pharmaceutical business. - Consolidated revenue up 9% YoY - Interanational revenues at Rs. 999 crore, contributing 74% to the overall mix and up 10% YoY - EBITDA margins at 17.5% and normalised PAT margins at 5.1% - The company had total of 649 filings for formulations of which 189 have been approved in various regions of the world including 58 ANDAs in the US and 41 Dossier filings in the Europe. - Income from operations was at Rs. 706 crore better by 18% YoY and having 52% share in overall revenues. ]]> <![CDATA[ToRCH testing kits to rescue infants]]> https://biospectrumindia.com/news/95/5309/torch-testing-kits-to-rescue-infants.html https://biospectrumindia.com/news/95/5309/torch-testing-kits-to-rescue-infants.html Fri, 02 Aug 2013 16:48:00 +0530 According to the latest state of the World's Mothers Report from 'Save The Children', more than 300,000 babies die within the first 24 hours of being born in India each year. An innovative, new, low-cost ToRCH testing kit designed in New Zealand aims to help doctors prevent thousands of deaths and assist in reducing India's infant mortality rate. The brain child of Indian born scientist, Dr Sarita and Anand Kumble of New zealand company, Pictor Ltd. The revolutionary testing kit provides a simple low cost testing platform for five of the major killers in infants- toxoplam, rubella, cytomegalo virusand Herpes simplex Virus 1 and 2. The name ToRCH is an acronym for five infectious diseases. "The ToRCH infections are responsible for causing over 20 percent of deaths in new born infants in India and across the South East Asia. These diseases also cause hearing impairment, eye problems, mental retardation, and autism. Traditional tests examining these pathogens have often been too expensive for many poor families, leaving doctors to make their diagnosis based on symptoms alone" said Dr. Kumble of Pictor Ltd. Used on expectant mothers, Pictor Ltd's test utilises cutting-edge immunodiagnostic technology which allows upto eight tests to be accurately performed together on a specially designed microscope slide, using only a single dop of blood. Pictor Ltd developed the world-class technology in Auckland, New Zealand, with the aim of offering the low cost diagnostic solutions to developing parts of the world, and has already launched the kits in Thailand and Malaysia with much success. ]]> <![CDATA[Mahyco and Arcadia Biosciences achieved Development of Nitogen Use Efficient Rice (NUE)]]> https://biospectrumindia.com/news/95/6423/mahyco-and-arcadia-biosciences-achieved-development-of-nitogen-use-efficient-rice-nue.html https://biospectrumindia.com/news/95/6423/mahyco-and-arcadia-biosciences-achieved-development-of-nitogen-use-efficient-rice-nue.html Thu, 01 Aug 2013 17:36:27 +0530 Mahyco Seeds, one of the largest seed companies in Southeast Asia and Arcadia Biosciences, Inc. , an agricultural technology company, announced the achievement of a key milestone in the development of Nitrogen Use Efficient (NUE) rice. "Mahyco's achievement is a validation of benefits that can be realised from NUE technology, and is a significant step in the direction of improving food security, and environmental footprint of agriculture in Southeast Asia," said Eric Rey, President and CEO of Arcadia. In achieving this key milestone, Mahyco clearly demonstrated that NUE technology significantly increased plant growth and yield in multiple rice lines developed by the company. Rice lines incorporating NUE technology showed double-digit increase in key plant performances and yielding measures. Beyond NUE rice, Arcadia and Mahyco are also working on a number of other technologies and crops to increase farm productivity and reduce environmental impact in the region. Raju Barwale, Managing Director of Mayhco said, "We are overwhelmed to achieve this key milestone in the development of NUE rice. We are looking forward that this collabration with Arcadia on NUE rice will help farmers. Mahyco is committed to providing cutting edge technologies to the farming community." ]]> <![CDATA[The World Hepatitis Alliance calls for urgent attention]]> https://biospectrumindia.com/news/95/3272/the-world-hepatitis-alliance-calls-for-urgent-attention.html https://biospectrumindia.com/news/95/3272/the-world-hepatitis-alliance-calls-for-urgent-attention.html Tue, 30 Jul 2013 17:59:27 +0530 Recently on World Hepatitis Day, the World Hepatitis Alliance has called for urgent attention to be given to recent figures showing that although viral hepatitis kills as many as HIV/AIDS, the great majority of countries have no programmes in place to tackle it.'Viral hepatitis is the 8th leading cause of death worldwide, killing as many people as HIV/AIDS every single year' says Charles Gore, President of the World Hepatitis Alliance. '500 million people worldwide are chronically infected. In the face of these numbers how is it possible that viral hepatitis receives so little priority across the world?'Presently, diseases receive attention and funding depending on their global priority. However the global priority list does not necessarily reflect the real burden of disease. This has led to responses that are disproportionate to disease impact, and has left some diseases tragically under-resourced. Therefore, the majority of governments have failed to dedicate resources to viral hepatitis, even in countries where prevalence is up to 20%.The Global Report released by the World Health Organization (WHO) this month showed the extent to which viral hepatitis is ignored. Only 37% of countries have a national strategy or plan for viral hepatitis, and less than 30% reported having a department responsible solely for viral hepatitis related activities. The lack of response to the world's 8th biggest killer is truly baffling. Not only does it put millions of lives at risk by allowing this silent epidemic to grow, it leaves the 500 million people who are acutely infected entirely abandoned without support or recognition.The Global Burden of Disease study released last year in the Lancet shows that viral hepatitis was responsible for almost 1.45 million deaths in 2010, the same as HIV/AIDS and importantly more than TB or Malaria. Despite this enormous annual death toll, leaders in global health consistently leave it off their agendas. In 2010 the WHO openly recognized that viral hepatitis is a prime cause for concern by making World Hepatitis Day one of only 7 world health days formally recognized by WHO and all Member States. Nevertheless, major changes to the global health point of view are yet to be seen. ]]> <![CDATA[Dr Reddy's June quarter profit of 7%]]> https://biospectrumindia.com/reports-white-papers/95/3270/dr-reddys-june-quarter-profit-of-7.html https://biospectrumindia.com/reports-white-papers/95/3270/dr-reddys-june-quarter-profit-of-7.html Tue, 30 Jul 2013 17:53:46 +0530 Dr Reddy's Laboratories Ltd (NYSE: RDY), posted a 7% increase in consolidated net profit for the June quarter, well below analysts' outlooks.Net profit for India's largest drug maker by sales increased to Rs.335.98 crore in the fiscal first quarter from Rs.360.93 crore in the same period a year earlier. Sales rose by 12% to Rs.2,844.92 crore.According to a Reuters report, analysts on an average had expected net profit at Rs.429 crore on net sales of Rs.3,116 crore. According to Mahida, the company's sales growth was below par at 12% year-on- year, as the company posted lower than expected growth across geographies. "The 7.7% growth in Russia and 0.3% growth in domestic formulations business performance was most disappointing," he said in the report.Dr. Reddy's Laboratories Ltd. is an integrated global pharmaceutical company, working to provide affordable and innovative medicines for healthier lives. Through its three businesses - Pharmaceutical Services and Active Ingredients, Global Generics and Proprietary Products. Gross profit margin for Q1 FY14 stood at 52.8%, marginal drop of 50 basis points compared to Q1 FY13. Corresponding values for Global Generics and PSAI segments for the year are at 61.6% and 19% respectively. GG gross margin improved primarily on account of higher contribution from new product launches in North America Generics, where as PSAI gross margin declined, primarily on the back of lower number of launch molecules to our customers and relatively higher overheads during the quarter. ]]> <![CDATA[Dr. Lal PathLabs Taps IBM Big Data Insights ]]> https://biospectrumindia.com/news/95/7530/dr-lal-pathlabs-taps-ibm-big-data-insights-.html https://biospectrumindia.com/news/95/7530/dr-lal-pathlabs-taps-ibm-big-data-insights-.html Tue, 30 Jul 2013 16:05:00 +0530 IBM recently announced that Dr. Lal PathLabs (LPL), a pioneer in diagnostic services in India, is leveraging IBM consulting services to improve the quality of information and service to its patients, becoming one of the few labs in the country with a centralized view of patient information across its laboratories and Patient Service Centers. With global expansion plans, LPL wants to transform its existing data system into a knowledge stream with collaboration tools across 80 locations that increase quality of patient reports, research, development and productivity. IBM assisted LPL to select and implement the right system to transform their laboratory information management process, thereby improving the reliability of sampling processes, meeting regulatory compliance and industry standards, and providing comprehensive reporting, monitoring and analysis capabilities. "Sourcing and analyzing Big Data in real-time from multiple sources is a growing challenge across industries. With the right combination of technology and services, organizations like LPL can take advantage of the increased availability of data to improve patient service and care, achieving the very highest industry standards," said Jeby Cherian, Vice President and Managing Partner, Global Business Services, IBM India/South Asia. As going live in 4 months, the solution has already integrated over 25 highly-specialized departments and 250 instruments, sufficed thousands of patients, processed millions of samples/reports, while supporting critical business needs, moving data to a new application, and imparting training to hundreds of end users and administrators, both in India and abroad. As pharmaceutical, biotechnology and healthcare companies seek more cost-effective, efficient technologies to help them meet customer expectations and ensure regulatory compliance, it is a business imperative to have a customizable information management system. Working with IBM, LPL can integrate, automate and optimize data for new insights and also make it cost effective, scalable and secure. LPL, with a proven record of accomplishment of more than six decades for strict adherence to international standards and benchmarks, it offers quality services to its customers in the form of more than 4000 types of tests."We serve over 30,000 patients per day, resulting in more than 90,000 samples per day. It was imperative for LPL to apply this large pool of data to improve the experience of our customers," said Dr. Om P Manchanda, Chief Executive Officer, Dr Lal PathLabs. "IBM's industry expertise and deep domain knowledge helped us derive real time insights to improve collaboration and boost growth across the company." ]]> <![CDATA[Dr. Reddy's launches Donepezil Hydrochloride Tablets]]> https://biospectrumindia.com/news/95/1775/dr-reddys-launches-donepezil-hydrochloride-tablets.html https://biospectrumindia.com/news/95/1775/dr-reddys-launches-donepezil-hydrochloride-tablets.html Tue, 30 Jul 2013 12:17:03 +0530 Dr. Reddy's Laboratories(NYSE: RDY) has launched Donepezil Hydrochloride Tablets, 23 mg, in the US market following the approval by the United States Food & Drug Administration (USFDA) of Dr. Reddy's ANDA for Donepezil Hydrochloride Tablets, 23 mg. The new drug is therapeutic equivalent generic version of ARICEPT®, 23 mg. The ARICEPT®, 23 mg brand had US sales of approximately $92.6 million MAT for the most recent twelve months ending in May 2013, according to IMS Health. Dr. Reddy's Donepezil Hydrochloride Tablets, 23 mg is available in bottle count sizes of 30 and 90. The company announced the approval of the new drugs in the US market on 27th July, 2013 ]]> <![CDATA[ISCR take on Clinical trials in India]]> https://biospectrumindia.com/news/95/3355/iscr-take-on-clinical-trials-in-india.html https://biospectrumindia.com/news/95/3355/iscr-take-on-clinical-trials-in-india.html Mon, 29 Jul 2013 17:06:00 +0530 Recently on 26 July, the Supreme Court Judges were appreciative of the fact that the Ministry of Health was taking steps to strengthen the regulatory framework for the conduct and monitoring of clinical trials in India. The Supreme court also granted time to the petitioners to respond with suggestions that will further strengthen the regulatory environment for clinical research in the country. Indian Society for Clinical Research (ISCR) is fully supportive of the initiatives undertaken to create a more robust and regulated environment in India for the conduct of clinical research. As per the spokesperson of ISCR, "Towards this end, we work very closely with different stakeholders on regulatory developments. Any steps to ensure the practice of the highest standards of ethics and quality and the protection of patient rights and safety is welcomed by us".The Government of India sponsored Working Group on Disease Burden for the 12th Five Year Plan refers to the "triple burden of disease" that developing countries like ours are facing arising from Communicable Diseases, Emerging Non-Communicable Diseases related to lifestyles and emerging infectious diseases. In the larger context of India's unique healthcare demands and the growing incidence of endemic diseases and emerging lifestyle diseases, the need of clinical research is prominent . It will help to develop new and effective medicines and vaccines to tackle mammoth disease burden and unmet medical need. India has 16 percent of the world's population and 20 percent of the global disease burden and yet, less than 2 percent of global trials take place in India. ISCR aims to build awareness of clinical research as a specialty in India and to facilitate its growth in the country. ]]> <![CDATA[Piramal Healthcare invest USD$ 2.5 millions]]> https://biospectrumindia.com/news/95/7524/piramal-healthcare-invest-usd-2-5-millions.html https://biospectrumindia.com/news/95/7524/piramal-healthcare-invest-usd-2-5-millions.html Mon, 29 Jul 2013 16:38:00 +0530 Piramal's Healthcare vertical declared that it is going to invest whopping amount of USD 2.5 millions at its FDA approved Grangemouth, UK site to ascent one of its ADC manufacturing suites, from clinical to commercial phase owing to great customer demand.Vijay Shah, Executive Director & Chief Operating Officer of Piramal enterprises, says, "This investment supporting an emerging platform in the field of oncology treatment, aligns completely with our values as an organization. We view ADC's as a strategic area of growth for our Pharma Solutions business and this investment indicates our determination to support our customers with facility and capacity."The batch size offered from the Grangemouth facility ranges from 1-1.5 kg. However they have capacity for further expansion on site if required. As a part of the investment, the areas supporting the manufacturing suite will also be upgraded to new areas for buffer preparation, equipment preparation and antibody freeze/thaw. They also intends to expand its 'Proof of Concept' (POC) offer at Grangemouth, for pharma companies looking to demonstrate antibody and toxin suitability for use as an ADC. ]]> <![CDATA[Pricing policy implementation to result in low-key performance in India]]> https://biospectrumindia.com/news/95/2123/pricing-policy-implementation-to-result-in-low-key-performance-in-india.html https://biospectrumindia.com/news/95/2123/pricing-policy-implementation-to-result-in-low-key-performance-in-india.html Mon, 29 Jul 2013 15:02:33 +0530 The growth in domestic formulations to be weak across companies given the formed implementation (started in early June) of the new drug pricing policy. There has been uncertainty in the market resulting in lower offtake by the channel and companies also being cautious in building inventory. The impact of price cut may also be partly reflected in the current quarter says the report prepared by Kotak Institutional Equities.According to it, there is higher growth for Sun Pharma (20 percent yoy) and Glenmark (16 percent yoy) while Lupin is estimated at 12 percent. Further, the ban on Pioglitazone is not expected to be reflected in the current quarter (primarily for Sun Pharma and Lupin). For the remaining generics, the expected growth in domestic market will be between 8 percent and 10 percent for the quarter. Sun Pharma to benefit from price hikesThe favorable pricing environment in Doxycycline market to sustain for the current quarter for Sun Pharma at 29 percent yoy. There has been additional price increases in Taro by 14 percent, which are expected to offset the incremental competition in Nystatin/Triamcinolone. Doxil sales are expected to be lower yoy given resumption of supplies by the innovator (J&J). Further the report states, the overall expected EBITDA margin is at 45.1 percent, which is 70 bps lower yoy. Lupin will benefit from generic Tricor sales on a yoy basis, which is expected to drive the 210 bps improvement in EBITDA margin. Impact on price erosion due to Mylan entry in Tricor market remains the key monitorable for Lupin. Glenmark is expected to benefit from launch of Zolmitriptan in the US. Excluding the MTM impact, we expect 110 bps yoy decline in EBITDA margin for Glenmark. ]]> <![CDATA[Biocon Delivers a Healthy Growth of 22% driven by strong traction in Biopharma]]> https://biospectrumindia.com/reports-white-papers/95/5973/biocon-delivers-a-healthy-growth-of-22-driven-by-strong-traction-in-biopharma.html https://biospectrumindia.com/reports-white-papers/95/5973/biocon-delivers-a-healthy-growth-of-22-driven-by-strong-traction-in-biopharma.html Fri, 26 Jul 2013 15:53:53 +0530 Biocon revenue growth in Q1 FY2013 reflects the inherent strength of product portfolios. Biopharma business increased by 21% YoY to Rs 439 crores, branded formulations 17% YOY to 101 crores and research services by 26% YoY to 155 crores. In the financial results group EBITDA and PAT margins at 23% and 15% respectively were noticed. Chairman and Managing Director, Kiran Mazumdar-Shaw said, "We are pleased to report a strong set of numbers for Q1 FY13. The new organisation structure has enabled us to deliver superior results with the core business performing strongly. Biocon's Insulins buisness continues to do well. The current fiscal will see us consolidateour various initiatives whilst we continue our investment in our biosimilars and novel molecules, to deliver a sustainable growth platform." The small molecules portfolio delivered a strong performance in the current quarter , led by Immunosuppressants and specially molecules like Fidaxomicin and Orlistat. The statins portfolio has remained stable, despite the chnaging market dynamics. The branded formulations vertical grew at 17%YoY this quarter, vis-a-vis the industry growth of 8% YoY. A huge R& D investment of 43 crores which is exactly 10% of biopharma sales has been invested. Small molecules and biosimilars biopharma grew at 19% YoY at Constant Exchange Rate (CER), with broad based growth across the small molecules and biosimilars portfolios. ]]> <![CDATA[Novartis India announces results for 1st Quarter]]> https://biospectrumindia.com/reports-white-papers/95/3185/novartis-india-announces-results-for-1st-quarter.html https://biospectrumindia.com/reports-white-papers/95/3185/novartis-india-announces-results-for-1st-quarter.html Fri, 26 Jul 2013 15:45:30 +0530 Novartis India Limited approved results for the quarter ended 30 June 2013. In the period under review, total income from operations of Rs 223.1 crore registered a growth of 1.6% over the corresponding quarter of the previous year. During the quarter under review, core business, Pharmaceuticals recorded total income from operations of Rs 162.8 crore, the generics business registered total income from operations of Rs 15 crores. The animal health business registered total income of Rs 25.6 crores. The report declared profit before tax was Rs 22.2 crore. After providing for tax of Rs 8.4 crore, profit after tax stood at Rs 13.9 crore. The expanded scope of drug price control is likely to have a significant impact on both revenue and profitability of the company. ]]> <![CDATA[India gets its first bio-entreprenurship masters program ]]> https://biospectrumindia.com/news/95/3121/india-gets-its-first-bio-entreprenurship-masters-program-.html https://biospectrumindia.com/news/95/3121/india-gets-its-first-bio-entreprenurship-masters-program-.html Fri, 26 Jul 2013 12:44:00 +0530 BIORx Venture Advisors Private Ltd (BIORx) has announced the launch of India's first-ever comprehensive masters program 'BIO-ACCELERATOR' on bio-entreprenurship with the theme "Accelerating Innovations to marketplace '' - A small step towards strengthening India's Bio-economy". Perceiving the acute need for enabling technologists to become successful businessperson in the life sciences sector, BioRx Boutique Investment Bank dedicated to providing financing and strategic partnership solutions to the life sciences Industry in India, has designed this program on bio-entrepreneurship. This program is devised for working executives, Ph.D scholars and post-doctoral scientists aspiring to accelerate the path of their discovery to marketplace. BIORx (as an acceleration partner) has teamed up with National Institute of Immunology (NII), New Delhi (an autonomous institution of the Department of Biotechnology, Govt. of India) as a technology partner and Foundation of Innovation and Technology Transfer (FITT) (as an incubation partner) to enable the successful execution of the research Ideas to marketplace and recently signed up a tri-partite MoU to strengthen the ecosystem further to accelerate the commercialization of the Life Sciences Innovation. BIORx has earlier conducted the first-ever masters class on venture capital and private equity in life sciences under the aegis of BIOASIA at Hyderabad, a Global Bio-business forum. The workshop was supported by BIRAC (A government of India enterprise). It was attended by 30 chief executive officers/ chief technology officers (CEOs/CTOs) of various life sciences organizations including some foreign companies. The overall feedback by participants was very encouraging. Mr Vishal Gandhi, managing partner and CEO, BIORx considers this initiative as an effort aimed at not only bridging theindustry-academia gap but also at helping technologists accelerate laboratory innovation into business success to contribute to India's economy. NII, FITT and BIORx Venture Advisors are committed to support India's emerging bio-economy model by providing superior learning ecosystem in this regard. Dr Chandrima Shaha, Director, NII says: "NII is very happy to associate itself as the technology partner in this initiative as we believe it will contribute significantly towards creating awareness in translating laboratory leads into bioproducts and processes". Dr A. Wali, managing director of FITT says, "This capacity building initiative shall positively impact the techno-entrepreneurial ecosystem". The master class starts with an inaugural function on the evening of 20 September, 2013 and concludes at 5pm on 23rd September at the National Institute of Immunology, New Delhi. ]]> <![CDATA[3M Healthcare and NABH honoured with eINDIA Award ]]> https://biospectrumindia.com/news/95/3110/3m-healthcare-and-nabh-honoured-with-eindia-award-.html https://biospectrumindia.com/news/95/3110/3m-healthcare-and-nabh-honoured-with-eindia-award-.html Fri, 26 Jul 2013 12:28:19 +0530 Better healthcare is a critical element of sustained development for India. However, a key challenge India has in expanding quality healthcare is the demand supply gap. Bridging this gap is only possible through collaboration - collaboration between healthcare providers, private organizations and manufacturers, as well as public bodies to uplift standards of healthcare in India. One such collaboration, between 3M India Ltd. and NABH (National Accreditation Board for Hospitals & Healthcare Providers), where a Memorandum of Understanding (MoU) was signed to promote best practices and standards in hospitals to prevent healthcare associated infections and also promote quality care for patients in India, was recognized at the eINDIA awards, that was concluded on 23rd July 2013 in Hyderabad. 3M and NABH were awarded for their project "Up-gradation of standards & practices in healthcare in India (A 3M NABH joint initiative)". The Awards were presented by Honourable Minister of IT, Govt. of Andhra Pradhesh, Mr Ponnala Lakshmaiah, Mr P K Mohanty, Chief Secretary - Govt. of Andhra Pradhesh and Mr. Sanjay Jaju, Secretary - IT, Govt. of Andhra Pradhesh. The project involved designing of several educational modules to upgrade health care services. These modules were then demonstrated hands-on through several extensive day long workshops designed on topics such as Surgical Site Infection Prevention, Sterilization Assurance, IV Therapy - Catheter Related Blood Stream Infection Prevention, Wound Management & Casting workshops across India to healthcare providers. Over the last one and a half years, 14 such workshops have been organized all over India with participation from more than 450 heatlhcare providers across 150 hospitals. Over 50 industry experts along with 3M personnel have facilitated these workshops through a healthy mix of lectures, case studies, hands-on demo and panel discussions. 3M has also developed toolkits for many hospitals to ensure effective implementation by healthcare providers after attending these workshops. The participants of these workshops have now become the ambassadors of best healthcare practices in their respective institutions while 3M & NABH are continuously working to take this project forward to many more hospitals and cities with more relevant infection prevention topics. On receipt of the award, Mr. Gautam Khanna, Executive Director, 3M Health Care Business - India, said, "We are honoured to receive this prestigious award. Our collaboration with NABH is a successful example of how the government objective of high quality standards of healthcare can be achieved by leveraging private expertise. Empowering healthcare professionals through upgrading of practices is critical to improve the standard of healthcare in India. Achieving this has come about as a result of the tremendous support and teamwork we have experienced with NABH." Dr. Kalra, CEO, NABH said, "Quality in Healthcare is being recognized as a key parameter all over the world. It aims directly at saving precious lives. Management of medication and control of infections, have emerged as two principal points, which if attended, can improve patient safety many fold. NABH is pleased that our collaboration with 3M in a mission to promote quality healthcare in our country has got this recognition." This recognition also complements 3M's ongoing efforts to help prevent and control infection related to morbidity and mortality, thus raising the standards of quality of healthcare imparted in hospitals and subsequently reduce the cost of care linked to healthcare associated infection. This is 3M's third national award within a year after winning the prestigious Wound Management Company of the Year Award at the Frost & Sullivan Healthcare Excellence Awards, and the QCI - DL Shah National Award for Healthcare Services awarded by the Quality Council of India, for its significant contribution towards infection prevention. 3M Health Care offers solutions in the medical, oral care, drug delivery, food safety and health information markets. We have an unparalleled ability to connect people, insights, science and technology to think beyond today, solve problems, and make better health possible. Our culture of collaboration empowers us to discover and deliver practical, proven solutions that enable our customers to protect and improve the health of people around the world. National Accreditation Board for Hospitals & Healthcare Providers (NABH) is a constituent board of Quality Council of India, set up to establish and operate accreditation programme for healthcare organisations. The board is structured to cater to the much desired needs of the consumers and to set benchmarks for progress of health industry. The board, while being supported by all stakeholders including industry, consumers, government, has full functional autonomy in its operation. ]]> <![CDATA[Varsities should do research in industry-sponsored ideas : Shashi Tharoor ]]> https://biospectrumindia.com/news/95/3053/varsities-should-do-research-in-industry-sponsored-ideas-shashi-tharoor-.html https://biospectrumindia.com/news/95/3053/varsities-should-do-research-in-industry-sponsored-ideas-shashi-tharoor-.html Fri, 26 Jul 2013 11:15:00 +0530 Mr Shashi Tharoor, minister of state for human resource development, has suggested that the private sector should ask universities to undertake research on an industry-related idea and their R&D efforts could be rewarded by absorbing the student-innovators in companies sponsoring the research. Tharoor was speaking at the 'Global R&D Summit 2013 - Destination India' organized by Federation of Chambers of Commerce and Industry (FICCI) in association with department of science and technology (DST), government of India at New Delhi on July 25, 2013. . He said that India ranked poorly in terms of global R&D expenditure. While the figure was 33 per cent for the US, 24.5 per cent for Europe, 12.5 per cent for China and Japan , India's R&D spend was a meager 2.1 per cent for India. Also, FDI flows into R&D in India stood at 0.5%, according to a Wharton report published in 2005. Dr Tharoor ascribed this situation to the fact that "for far too long we have taken the complacent view of the role of R&D in nation building.""The challenges of the 21st century for India were tackling the demand for food and water and eradicating poverty and illiteracy," he said and added that several Bill pertaining to education were pending in Parliament. These needed to be debated and passed by the two houses. Once this happens India's education sector, including technical education, will undergo a sea change. On the occasion, Dr. Tharoor released the FICCI-Battelle Knowledge Paper on 'India's Emerging Competitiveness as Destination of Global R&D'.Dr R. Chidambaram, Principal Scientific Adviser to the Government of India, in his keynote address emphasised the need to put R&D high on the national agenda, backed by high quality manufacturing skills and leveraging international cooperation to reap the advantages of the third industrial revolution. He said that India was beginning to realise that it not enough to get proven technologies, a synonym for obsolete technology and the benefits that can be reaped from being the first mover in the R&D space.Dr. Chidambaram said the third industrial revolution that is being witnessed now is bring driven by the internet, digital manufacturing and other advanced technologies as also by the desire to develop green technologies.Dr. T. Ramasami, Secretary, Department of Science & Technology, who gave the theme address,pointed out that the need of the hour was to convert knowledge into wealth. He said that majority of research was currently focussed on achieving excellence.It was important to channelise the fruits of technological excellence into the prosperity of the people. He also stressed on the need for making innovations affordable so as to rach the benefits to the masses. Dr Birendra Raj Dutt, Chairman & MD, APIC, USA, underlined the need to cultivate researchers who work on mission mode, have commitment to leadership and consider promotion of R&D as a national effort. He said 'Being First' in R&D requires courage to try hard and a profienct understanding of technology that provides the ability to s and execute the future and an understanding of how to execute large, new projects.Ms. Naina Lal KIdwai, President, FICCI, suggested that the National S&T policy should be oriented towards 'output directed development path', as opposed to 'input driven strategy' followed up till now. Basic research should be followed on 'goal oriented approach' to connect knowledge generation with wealth generation and practical problem solving and Government funding policy in R&D should have a 'venture funding model' for private sector projects (particularly for SMEs) as adopted by some developed countries, she said. She said that India's public spend in R&D is below average of China, South Korea and most Western countries. It was therefore imperative that the Government should stick to its commitment for steady increase in budget outlay for R&D and double current investments over next 5-8 years. Further, India's private sector investment in R&D is less then 25% of overall R&D spend. It was therefore necessary to create an aggressive policy environment for boosting private sector investment in R&D. Apart from the existing R&D offset credit policy for industry, there should be adequate tax-break incentives and a fast track patenting facility for breakthrough innovations. The government should introduce legislation for allowing public sector scientists to file patents, create new enterprises and share financial returns of their inventions, the FICCI chief pointed out. Ms. Kidwai said that there is considerable lack of industry-academia-public lab linkage in the R&D ecosystem, leading to low competitiveness. The Government, she said, needed to introduce structured platforms for open collaboration between all R&D stakeholders under different S&T sectors and facilitate researcher exchange from academia and public labs to industry and vice-a-versa to create better synergy in public-private and basic-applied R&D.The inaugural session of the two-day conference was also addressed by Dr. Marakand Phadke, Chairman, FICCI National Committee on S&T/Innovation and Senior Vice President-Innovations, Reliance Industries Ltd. and Dr. A. Didar Sigh, Secretary General, FICCI. The two-day summit has brought together local and global R&D experts from government, industry and academia, along with key stakeholders such as policy-makers, business leaders, innovators, entrepreneurs and investors constituting the R&D ecosystem. It is exploring the emerging role of scientific and industrial R&D as cornerstone for economic development of the country and create an international platform for open exchange of ideas, best practices and strategies with various stakeholders across the globe. The exhibition organized alongside the summit is showcased some of the most innovative and successful R&D projects, programs and initiatives from government, industry and academia and offers a high-level networking and business opportunity platform for participants. ]]> <![CDATA[Strides Arcolab recieved WHO prequalification for Artemether+Lumifantrine]]> https://biospectrumindia.com/news/95/3351/strides-arcolab-recieved-who-prequalification-for-artemetherlumifantrine.html https://biospectrumindia.com/news/95/3351/strides-arcolab-recieved-who-prequalification-for-artemetherlumifantrine.html Thu, 25 Jul 2013 17:18:14 +0530 Recently Strides Arcolab has received WHO prequalification for Artemether+Lumifantrine (AL) and expects for more 2-3 key approvals during second half, 2013.With respect to pharma regulatory updates the company has 46 filings till date with the United States Food and Drug Administration (USFDA) with 18 pending approvals. "We are pleased with our performance which is in line with our guided EBITDA and Revenues. With recent product approvals, we expect to deliver a strong second half in our pharmaceutical business,"said Arun Kumar, Vice Chairman and Group CEO, Strides Arcolab Limited The product development progressing will be as per schedule for commercialisation in early 2015.The financial results for the global pharma clearly indicated that consolidated pharma revenues in the first half 2013 at Rs 464 crores with an EBITDA of Rs 101 crores impacted by an exchange loss of Rs 15 crores. According to the financial report Strides Arcolab, it was noticed that revenue guided at Rs 1000 crores with an EBITDA of Rs 200 crores. Apart from the growth in the consolidated pharma, the designed phase of customised biotech facility at Bio-Xcell ecosystem Malaysia is progressing and ground breaking scheduled for fourth quarter 2013. Strides Arcolab develops and manufactures a wide range of IP-led niche pharmaceutical products with an emphasis on sterile injectibles. ]]> <![CDATA[We are a much better company today says Ranbaxy]]> https://biospectrumindia.com/news/95/3354/we-are-a-much-better-company-today-says-ranbaxy.html https://biospectrumindia.com/news/95/3354/we-are-a-much-better-company-today-says-ranbaxy.html Thu, 25 Jul 2013 14:55:00 +0530 The dust seems to have settled over the Ranbaxy's case related to the alleged quality issues by the USFDA in a US court. The development not only led to a fear among the general public in India but also raised serious questions on whether the generic drugs are low on quality. However, Ranbaxy feels that much was made out of the entire story and out of context references would not serve any purpose for Indian pharma industry. Ranbaxy in a straightforward response to the queries from BioSpectrum, has clarified that technically it did not lose the case in the US court over any quality issues. Rather it says that the fine was a part of the settlement. Giving their version of the story, the Ranbaxy spokesperson mentioned, "On May 13, 2013, Ranbaxy announced conclusion of a previously disclosed investigation by the U.S. Department of Justice (DOJ) of data integrity and manufacturing processes at certain Ranbaxy facilities in India. In anticipation of this settlement with the DOJ, Ranbaxy had earlier in 2011 made a financial provision of US$ 500 million. Therefore the recent settlement with DOJ does not materially impact Ranbaxy's current financial situation or performance." Talking about the need for the company to move on, the spokesperson said, "It's important to note that the investigation related to conduct which occurred several years ago and Ranbaxy is a different company today. The steps we have taken over the recent years reflect the wide-ranging efforts of the current board and management to address certain conduct of the past and ensure that Ranbaxy moves forward with integrity and professionalism in everything we do." The Apollo hospitals that has earlier kept the Ranbaxy drugs on hold later worked with Ranbaxy to validate the necessary documentation in line with quality standards followed by International quality certifying authorities. In a statement, it said, "Ranbaxy has provided us Batch quality certification for all their products certified by the Government approved certifying laboratories. The reports completely satisfy the quality norms stipulated by WHO-GMP, Department of Pharmaceuticals, Govt of India as well as Drug and Cosmetic Act. We have also understood the stance of the DGHS of India in this regard and received confirmation from them that there are no quality issues in the Ranbaxy Products currently marketed in India. We are glad that this issue has been resolved. We will continue to stock and dispense Ranbaxy products across all our pharmacies and continue to provide the best patient care without missing a beat." Also, the recent story of the PIL dismissal by Supreme Court for banning Ranbaxy drugs in India too gives them some respite in India. On being asked about their recent activities, Ranbaxy spokesperson revealed, "We have invested more than US$ 300 million in upgrading our facilities, in training, hiring the best consultants to impart skill-sets to the employees at Ranbaxy. All these will go to ensuring that Ranbaxy continues to have the best standards in the industry. We are fully committed to upholding the high standards that patients, prescribers and all other stakeholders expect." Dismissing any negative publicity for the company, the spokes person in exclusive interaction with the BioSpectrum elaborated, "Ranbaxy is the best known pharma brand from India. It has earned the respect of stakeholders all over the world. There is a lot of faith, trust and belief all over the world. Our stakeholders, including regulators and doctors have reposed faith and confidence in us. We believe they will continue to trust us as we operate from the paradigm of 'Quality and Patients First'. "Responsible companies such as Ranbaxy have earned India the reputation of being pharmacy to the world. We sincerely believe that because of their very high standards of operations these companies will continue to build the credibility of India as pharmacy to the world," he concluded while stressing on the fact that Ranbaxy is very much active in the pharma space. ]]> <![CDATA[FDA approval for Generic Glumetza: Lupin]]> https://biospectrumindia.com/news/95/8269/fda-approval-for-generic-glumetza-lupin.html https://biospectrumindia.com/news/95/8269/fda-approval-for-generic-glumetza-lupin.html Thu, 25 Jul 2013 11:01:00 +0530 Lupin limited pharma major announced today that its U.S. subsidiary, Lupin Pharmaceuticals, Inc (LPI) has bagged final approval for its Metformin Hydrochloride extended release tablets (HC1 Er) 500 mg and 1000 mg from the United States Food and Drug Administration (USFDA). Lupin's Metformin HC1 ER Tablets, 500 mg and 1000 mg strengths are the AB-rated generic equivalent of Santarus, Inc.'s Glumetza HC1 ER Tablets, 500 mg and 100 mg. Metformin HC1 Er tablets is a biguanide and is indicated as an adjunct to diet and excercise to improve glycemic control in adults with type 2 diabetes mellitus. ]]> <![CDATA[ Supreme Court appointed TEC is anti agriculture says ABLE-AG ]]> https://biospectrumindia.com/news/95/3357/-supreme-court-appointed-tec-is-anti-agriculture-says-able-ag-.html https://biospectrumindia.com/news/95/3357/-supreme-court-appointed-tec-is-anti-agriculture-says-able-ag-.html Tue, 23 Jul 2013 17:04:00 +0530 The Association of Biotech Led Enterprise - Agriculture Group (ABLE AG) has termed the document of Supreme Court appointed Technical Expert Committee (TEC) as regressive, biased and a troubled treatise that promises to push Indian agriculture into an archaic age. "The industry believes the TEC report besides being incomplete is also anti-science and anti-research and will severely dent the future of country's farmers besides destroying the domestic private and public sector research. While improving the testing programmes is a continuous process, we do not believe that testing should be stopped in the interim. Such stalling will not help us in understanding science better. This recommendation, if accepted by the Supreme Court, will put our agricultural research back by decades and will severely hamper progress," said Mr Ram Kaundinya, Chairman, ABLE AG. ABLE AG recognises that national leadership is well aware of the need for modern technology as evidenced from recent speech of President of India, and earlier by Prime Minister of India. India's agricultural productivity still ranks far below the best in the world, and reluctance to deploy novel and new technologies will have a far-reaching adverse impact denying Indian farmers and the domestic seed industry new technologies. Dr N Seetharama, Executive Director, ABLE AG said, "This report by four members of TEC can't be considered complete as SC appointed agriculture expert Dr RS Paroda's submission directly to the Supreme Court is yet to be made public." "India's robust science-based regulatory environment is comparable with global standards, and must be more predictable to encourage domestic agricultural research. We hope the Hon'ble Supreme Court will consider views from the scientific community, researchers, economists, farmers and the local Indian industry before taking a considered decision," added Mr Kaundinya. ]]> <![CDATA[BIRAC bioincubator, a new opportunity for entrepreneurs ]]> https://biospectrumindia.com/news/95/4149/birac-bioincubator-a-new-opportunity-for-entrepreneurs-.html https://biospectrumindia.com/news/95/4149/birac-bioincubator-a-new-opportunity-for-entrepreneurs-.html Tue, 23 Jul 2013 16:53:00 +0530 On July 07, 2013, the signing of the agreement between BIRAC and Regional Centre Biotechnology (RCB) took place on behalf of national capital region (NCR) Bio-Cluster. The agreement was signed by Dr Renu Swarup, managing director, BIRAC and Dr Dinaker Salunke, director RCB in the presence of Dr K Vijay Raghavan, secretary DBT and Dr M K Bhan, former secretary, DBT. At signing ceremony the directors of the NCR Bio-Cluster and other eminent scientists from DBT, National Institute of Immunology (NII), Translational Health Institute (THSTI), National Brain Research Centre (NBRC), and National Institute of Plant Geome Research (NIPGR) were also present. This step of Biotechnology Industry Research Assistance Council (BIRAC) has been for establishing a new world class bio-incubator in the department of biotecnology (DBT) Bioclusters at NCR, Faridabad. This will be important to foster techno entrepreneurship in biotechnology at national level, This BIRAC Bio-incubator will focus on the medical devices, Bbopharma- vaccines and diagnostics, industrial biotechnology. The Bio-incubator will provide the incubation space and other required services for entrepreneurs and start-up companies for their initial growth. ]]> <![CDATA[India faces shortage of Yellow fever vaccine ]]> https://biospectrumindia.com/news/95/3353/india-faces-shortage-of-yellow-fever-vaccine-.html https://biospectrumindia.com/news/95/3353/india-faces-shortage-of-yellow-fever-vaccine-.html Tue, 23 Jul 2013 16:02:00 +0530 Yellow fever disease is endemic in 44 countries in the world. 23 countries are in African continent and 11 countries in South American continent. India being free from Yellow fever disease, has to ensure that passengers visiting endemic countries can get protection by immunization by yellow fever vaccine. Single dose of 0.5 ml vaccine provides lifelong immunity and repeated visits do not require fresh YF vaccinations. Total annual demand of yellow fever vaccine for the country is around 1.8 lakh doses. There are 27 yellow fever vaccination centres in the country designated by Directorate General of Health Services, Ministry of Health & Family Welfare. Yellow fever vaccine to these centres is supplied by CRI, Kasauli (by partly 1/3rd manufacturing and partly 2/3rd by importing). No private hospital/ clinics/ institutions have so far been authorised by Govt. of India for providing YF vaccinations and issue WHO approved certificates. However, off late there has been shortage of yellow fever vaccine in the government of India designated Yellow fever vaccination centres since March 2013. It has been due to break-down of equipment at CRI, Kasauli, and interruption in supply of importation through WHO due to global shortage. Now due to shortage in supply, YF vaccination centres were informed by the government authorities that they should ask all the travellers seeking YF vaccinations, to procure the single dose YF vaccine vial (manufactured by Sanofi Pasteur) and get the WHO YF vaccination certificate (no cost was charged for this) at designated YF vaccination centres; as an interim measure; as government of India provides YF vaccination @ Rs. 300/- per dose and single dose Sanofi Pasteur in market is @ Rs. 1100/- According to the ministry statement, simultaneously, order was placed with WHO again for total requirement of 2.57 lacs doses (including balance requirement for 2012-13 and 2013-14). This supply order is yet to be received. As per WHO supplies are expected in August 2nd week. In view of the interruption of regular supply from CRI, K and anticipating the crisis situation, Sanofi Pasteur (the only company which has DCGI approval, but for single dose vaccine vial) was approached for supply of 60,000 doses (10 dose vial) in April, 2013. It was mentioned that, Sanofi Pasteur does not have license for multi-dose vial, it will have to get DCGI approval for Govt of India supply order. Meanwhile, the supplies have arrived in Mumbai port and sample for quality control certification has been sent to CRI, Kasauli on 18.07.2013. The report from CRI, K has been received and Yellow fever vaccine has been supplied to all the Yellow fever vaccination centres in four metros on July 22, 2013. The regular vaccination at all the Govt. of India centres is expected to be normal within this week. ]]> <![CDATA[Biological E's Japanese Encephalitis vaccine prequalified by the WHO]]> https://biospectrumindia.com/news/95/3352/biological-es-japanese-encephalitis-vaccine-prequalified-by-the-who.html https://biospectrumindia.com/news/95/3352/biological-es-japanese-encephalitis-vaccine-prequalified-by-the-who.html Tue, 23 Jul 2013 12:53:18 +0530 Indian Biopharmaceutical company Biological E (BioE) and European biotech company Valneva SE (Valneva)announced that the World Health Organization (WHO) has awarded prequalification for global use in adults of BioE's Japanese Encephalitis vaccine. BioE also expects the pediatric indication to be prequalified by the end of the year. This is the first prequalification of a Japanese Encephalitis vaccine, and is a key step in assuring the vaccine can be distributed to developing countries. Ms Mahima Datla, Managing Director, Biological E Limited said, "We are happy that our JE vaccine is the first ever WHO prequalified JE vaccine. It is an extremely important achievement for the vaccines community as our vaccine's prequalification is well in time to support GAVI's plans of introducing the JE vaccine in several developing countries." Biological E and Valneva (ex Intercell) constituted a relationship in 2005 for the development and commercialization of a Japanese encephalitis vaccine for endemic regions, based on Valneva's JEV technology. The vaccine, which was successfully formed under this partnership, is being marketed in India under the trade-name JEEV® and commercialization in other JE-endemic countries is planned. Thomas Lingelbach, Valneva's President and Chief Executive Officer and Franck Grimaud, Valneva's President and Chief Business Officer, said, "We share the excitement for this great achievement and are pleased that our technology used for IXIARO® will now help introducing an excellent vaccine in countries of substantial needs." (IXIARO® is an FDA and EMA approved vaccine). Biological E is in the news recently for venturing into a five year Pentavalent supply arrangement with GAVI, for forming a Joint Venture with GlaxoSmithKline (GSK) to create a six-in-one paediatric vaccine combining GSK's IPV and BioE's pentavalent vaccine, and for licensing Novartis's Phase II Typhoid Conjugate vaccine. ]]> <![CDATA[Indian agriculture is the largest private enterprise: Dr Ayappan ]]> https://biospectrumindia.com/news/95/7905/indian-agriculture-is-the-largest-private-enterprise-dr-ayappan-.html https://biospectrumindia.com/news/95/7905/indian-agriculture-is-the-largest-private-enterprise-dr-ayappan-.html Mon, 22 Jul 2013 09:42:00 +0530 Dr S Ayyappan, secretary, department of agriculture research (DARE) and director general, Indian Council for Agricultural Research (ICAR) inaugurated the Agri-Tech Investors Meet-2013 at NASC Complex here today. While delivering inaugural address, he emphasized upon the Indian Agriculture as the largest private enterprises run by 65 crore farmers serving a huge consumer base of 125 crore people. Today agriculture is a broad-based and complex system due to climate change and trade related issues. However, the system has a huge business potential to explore. In the ICAR system we are moving ahead from the primary to secondary agriculture offering advisories and services from seed to market, he said. Elaborating upon the various successful partnerships with private sector, he reiterated on the integration of innovation with incubation of technologies. In partnerships, we transfer trust and confidence along with the technologies, he added. Dr. Ayyappan called this event as innovators and investors meet and wished the event all success. Earlier, Dr D. Rama Rao, National Director, NAIP welcomed the dignitaries, participants and investors and outlined the programme of two-day Meet (18-19th July, 2013). He informed that more than 300 participants and delegates are participating in the event in which around 60 technologies are presented for commercialization. In the six technical sessions technologies with business potential will be presented and deliberated upon. Exclusive B2B meetings with technology developers will help further strengthen the Arvind R. Kaushal, Additional Secretary, DARE and Secretary, ICAR said in his remarks, this event is a befitting and quick response to the advice of Hon'ble President of India who stressed the importance of commercialization and dissemination of R&D results during his 85th ICAR Foundation Day Lecture (16th July, 2013). He appreciated the NAIP for catalyzing basic and strategic research with innovation as an integral part of the process. Deepak Ahluwalia, Task Team Leader and Senior Economist, World Bank appreciated the innovative approach of BPD units and urged ICAR to also move towards making Indian Agriculture visible on global platform. Dr. S. Mauria, ADG, IP&TM, ICAR; Dr. K.V. Balasubramaniam, MD, Indian Immunologicals Ltd.; Dr. Arvind Kapoor, CEO, Rasi Seeds Pvt. Ltd. and Dr. P.S. Pandey, National Coordinator, Component-1, NAIP also remarked and presented their views on the occasion. Dignitaries released a Compendium of NAIP technologies having potential for wide scale commercialization. Concurrently an exhibition is also arranged to showcase promising NAIP technologies. Agri-Tech Investors, Business Planning and Development Units, ICAR Institutes, Private enterprises and Senior officials from NARS and other related departments are participating in the event. The event is being jointly organized by ICAR-NAIP and ICRISAT. Dr. Kiran K Sharma, Chief Executive Officer - Agribusiness and Innovation Platform, ICRISAT lauded the role of ICAR in brining different stakeholders together and also proposed vote of thanks. ]]> <![CDATA[Availability not affordability is the primary healthcare access barrier : IMS Health Study ]]> https://biospectrumindia.com/news/95/3081/availability-not-affordability-is-the-primary-healthcare-access-barrier-ims-health-study-.html https://biospectrumindia.com/news/95/3081/availability-not-affordability-is-the-primary-healthcare-access-barrier-ims-health-study-.html Sat, 20 Jul 2013 16:02:00 +0530 While progress has been made in India over the past decade from both public and private sector initiatives, significant challenges persist in providing quality healthcare on an equitable, accessible and affordable basis across all regions and communities, according to a new IMS Institute for Healthcare Informatics study. The study - Understanding Healthcare Access in India: What is the Current State? - is the most comprehensive assessment of healthcare access undertaken since 2004 and is based on an extensive survey of nearly 15,000 households covering all socio-economic groups in rural and urban areas across 12 states. Information was gathered on more than 30,000 healthcare system interactions, supplemented by interviews with over 1,000 doctors and experts. "The healthcare system in India is not delivering affordable, acceptable and accessible healthcare to all Indians - which must be the test of its quality," says Arun Maira, member, Planning Commission of India. "Fixes to only parts of the system cannot produce the systemic changes required. In fact, some fixes to only a part, without considering their effects on other parts of the system, can backfire as indeed some are. IMS Health's healthcare access study provides an objective map of the whole system, which can be used to show where the leverage points for action are and to engage stakeholders to arrive at agreements of what strategies will improve the system's performance. I hope this study will be publicized widely and, supplemented with other information, used to stimulate a more collaborative discourse amongst stakeholders." The study was conducted by IMS Health India, with funding provided by the Organisation of Pharmaceutical Producers of India and the Pharmaceutical Research and Manufacturers of America. Support also was provided by the Indian Drug Manufacturers' Association. The survey, analysis and report preparation were conducted independently. According to Amit Backliwal, managing director, IMS Health India, "The study's findings provide a solid foundation for the discussion and debate required to align efforts by all stakeholders to advance healthcare access for all Indians. And, it provides a useful baseline for developing a roadmap to improve availability, raise performance levels and expand affordability in the long term." A 40-45 percent reduction in out-of-pocket expenditures for both outpatient and inpatient treatments can be attained through a holistic approach addressing four critical, interrelated dimensions of healthcare access. Those components are: physical accessibility and the location of healthcare facilities; availability and capacity of needed resources; quality and functionality of service required for patient treatment; and affordability of treatment relative to a patient's income. "While expanding healthcare access is a critical priority for both the Indian government and the private sector, the gap between aspiration and today's reality is all too apparent," said Murray Aitken, executive director, IMS Institute for Healthcare Informatics. "Challenges with resourcing and financing the public sector health infrastructure have a significant impact on the availability of healthcare workers and contribute to low-quality perceptions of public health facilities. This leads the rural-poor population to seek costlier treatment options - and adversely impacts overall healthcare access." The report's key findings include: â€¢ The provision of healthcare services in India is skewed toward urban centers and the private sector. Urban residents, who make up 28 percent of India's population, have access to 66 percent of the country's available hospital beds, while the remaining 72 percent who live in rural areas have access to just one-third of the beds. Similarly, the distribution of healthcare workers, including doctors, nurses and pharmacists, is highly concentrated in urban areas and the private sector. â€¢ Physical reach of any healthcare facility is a challenge in rural areas, particularly for patients with chronic ailments. Patients in rural areas must travel more than five kilometers to access an inpatient facility 63 percent of the time. Difficulty in accessing transportation options and the loss of earnings as a result of travel time lead to treatment being deferred, or facilities selected that may be closer but are not cost-effective or best suited to patient needs. This is especially true for patients suffering from chronic ailments. â€¢ Private healthcare facilities are being used by an increasing proportion of patients due to gaps in quality and availability of public facilities. Over the past 25 years, both rural and urban patients have increased their use of private service providers over public options. In 2012, 61 percent of rural patients and 69 percent of urban patients chose private in-patient service providers, up from 40 percent reported in a 1986/87 government survey. Long waiting times and the absence of diagnostic equipment in public facilities were cited as key reasons by more than 40 percent of those surveyed. Better quality of treatment in private, in-patient centers was cited as an additional reason by 38 percent of survey respondents. â€¢ Availability of doctors is a key reason for selecting private facility outpatient treatments. Across both urban and rural sectors, and among the poor and affording populations, at least 60 percent of those surveyed considered doctor availability as a significant reason for selecting private facilities for outpatient treatment. Absenteeism is typically higher in the less economically developed states of India. â€¢ Patients using private facilities face greater affordability challenges. The cost of treatment at private healthcare facilities is between two and nine times higher than at public facilities. For example, poor patients receiving outpatient care for chronic conditions at a private facility spent, on average, 44 percent of their monthly household expenditure per treatment, compared to 23 percent for those using a public facility. â€¢ Medicine costs as a proportion of out-of-pocket healthcare expenses remain high but stable. On average, across public and private facilities, and for chronic and acute diseases, medicines account for more than 60 percent of patients' total out-of-pocket expenses for outpatient treatments, and 43 percent for inpatient treatments. This share of expenditures for medicines has not increased since 2004 for inpatient treatments, and has decreased for outpatient treatments. Low insurance penetration - and current insurance plans that do not cover drug costs - make the total cost of medicines a continuing, significant burden for a majority of the population. â€¢ Improving the quality and availability of public healthcare facilities would drive the greatest reduction in patient out-of-pocket costs. The report assessed the relative impact of improvements across each of the four components that contribute to healthcare access. Enhancing the quality and availability of public healthcare facilities would curb the diversion of patients to private channels - enabling more patients to utilize lower-cost facilities and reduce their out-of-pocket costs. Effective financing mechanisms are a critical requirement to making healthcare more affordable for patients. Increased insurance penetration, while relevant across all segments of the Indian population, is particularly critical for those below the poverty line to ensure adequate coverage for out-patient care and prescription medicines. For the middle-income population, increased use of generic medicines, innovative delivery models and other cost-effective treatment options will yield more affordable care. ]]> <![CDATA[President calls upon scientists to work for technology-led development of agriculture]]> https://biospectrumindia.com/news/95/4909/president-calls-upon-scientists-to-work-for-technology-led-development-of-agriculture.html https://biospectrumindia.com/news/95/4909/president-calls-upon-scientists-to-work-for-technology-led-development-of-agriculture.html Sat, 20 Jul 2013 15:44:00 +0530 "In our economy, agriculture retains its primary importance in terms of value creation and employment generation. There are millions of farmers tilling on small and marginal holdings. Our challenge is to reach out to the last farmland and equip them with the best cultivation methods," said Pranab Mukherjee, President of India. He was delivering Foundation Day Lecture of ICAR on July 16, 2013 at New Delhi. He called upon the scientific fraternity to work towards a technology-led path for development of agriculture and prosperity for the farming community. While reminiscing the era of 'ship to mouth existence' before green revolution, he said, "India is today a leading producer of essential food commodities like wheat, rice, fresh fruits, vegetables, milk, eggs and fish. It has transformed from being a food-deficient to food surplus country and an exporter of agricultural produce. This, in the face of an ever increasing population, is a laudable achievement with few parallels." I compliment the agricultural research and development system of our country for their untiring efforts, he added. President of India launched 'Kisaan SMS Portal' that is capable of sending messages in regional languages on preferred crop and activity giving information and advisories. The portal is created by the Department of Agriculture & Cooperation, Government of India. President of India conferred Sardar Patel Outstanding ICAR Institution Award, Jagjivan Ram Abhinav Kisan Puruskar (National) and N.G. Ranga Farmer Award for Diversified Agriculture to ICAR Institutions of different categories and progressive farmers. Sharad Pawar, Union Minister for Agriculture and Food Processing Industries and President ICAR Society released Publications, 'Climate Change and Sustainable Food Security' and 'Aadhunik Phal Utpadan' (Hindi) and presented first copies to President of India. Shri Pawar was presiding over the function. Mr Pawar welcomed President of India and emphasized upon various challenges before India Agriculture. These challenges call for a paradigm shift in our research approach to harness the potential of modern science, encourage innovations in technology generation, and provide for an enabling policy and investment environment, he added. While complimenting ICAR Institutions for taking several worthy initiatives, he advised, "of course the real test of ICAR lies in the farmer's field. If farmer is able to produce more with less input and earn better, then I will consider ICAR's interventions are successful". Pawar conferred various categories of ICAR Awards 2012 along with Mr Tariq Anwar and Dr Charan Das Mahant, Union Ministers of State for Agriculture & Food Processing Industries. Dignitaries conferred ICAR Awards on 70 awardees under 15 different categories that comprise three Institutions, one AICRP, 55 scientists (10 women), nine farmers and two journalists. Dr. S. Ayyappan, Secretary, DARE and DG, ICAR welcomed President and other dignitaries and presented glimpses of ICAR achievements and the way forward. He informed that the Bureau of Indian Standards has granted the Quality Management Systems Certification ISO 9001: 2008 to the ICAR Headquarters and DARE on 5th July. Mr S.K. Khanna, Deputy Director General, Bureau of Indian Standards, presented the certificate to Dr. Ayyappan. Members of Parliament, Vice Chancellors of agricultural universities, Directors of ICAR Institutes, distinguished scientists, academia, senior officials of Ministry of Agriculture and other line departments graced the occasion. Shri Arvind Kaushal, Additional Secretary, DARE & Secretary, ICAR presented the vote of thanks. ]]> <![CDATA[GGSIPU to host international conference on biotechnology ]]> https://biospectrumindia.com/news/95/6818/ggsipu-to-host-international-conference-on-biotechnology-.html https://biospectrumindia.com/news/95/6818/ggsipu-to-host-international-conference-on-biotechnology-.html Fri, 19 Jul 2013 15:41:00 +0530 The first "Indraprastha International Conference on Biotechnology-2013 (IICB-2013)" is beng organized from October 22-25, 2013 at the Dwarka Campus of the University School of Biotechnology, Guru Gobind Singh Indraprastha University (GGSIPU), New Delhi. This conference is being organized with the view to showcase and explore the advances and innovations made by local and global researchers in various fields of biotechnology. The main focus of this event is to create a vibrant platform for exchange of ideas, best practices and strategies that would help to generate a road-map for future research and development in the country. IICB-2013 aims to bring together the best minds in the field of biotechnology and will provide an opportunity to foster academic relations and find global partners for future research collaborations. Scientific program of the conference would comprise of plenary and invited lectures from internationally and nationally acclaimed scientists. Contributory papers would be presented as posters, and some of these selected submissions will be invited for oral presentations. A detailed list of speakers will be available on the conference website. Abstracts of all the presentations will be compiled in a book that will be available during the conference. The conference is open for national and international academia, students and industry personnel. For further details please contact The Organizing Secretary IICB-2013, Prof. P.C. Sharma, Dean, University School of Biotechnology, Guru Gobind Singh Indraprastha University. According to Prof Sharma, "Biotechnology research offers great potential for global sustainable development. The scientific advances, innovative products and services are likely to offer better prospects for healthcare, environment, agriculture, energy and industrial sectors." Elaborating furthre, he added, "Over 200 delegated are expected in the conference. More than 40 invited speakers from India and abroad have already confirmed their participation in the event.The scientific programme will span the following tracks such as agricultural biotechnology, biodiversity and environment biotechnology and human health, industrial biotechnology, omics and In-silico biology, biosafety, IPR and biotechnology education, and biotechnology commercialization and entrepreneurship." ]]> <![CDATA[Venus gets GMP approval from Ukraine for all its nine manufacturing facilities]]> https://biospectrumindia.com/news/95/3336/venus-gets-gmp-approval-from-ukraine-for-all-its-nine-manufacturing-facilities.html https://biospectrumindia.com/news/95/3336/venus-gets-gmp-approval-from-ukraine-for-all-its-nine-manufacturing-facilities.html Fri, 19 Jul 2013 09:42:00 +0530 Venus Remedies has got all its nine manufacturing facilities approved for good manufacturing practices (GMP) by Ukraine, a Pharmaceutical Inspection Convention/Cooperation Scheme (PIC/S) member nation. Venus is the only Indian company to get Ukrainian GMP approval for large volume parenterals for its Panchkula plant in Haryana. The certification was granted by the National Agency for Food and Drug Administration and Control (NAFDAC), Ukraine after three rounds of audit. The nine facilities cater to the manufacture of cephalosporin injection, carbepenem, oncology liquid injection, oncology lyophilised injection, ampoules, liquid vials, general lyophilised vials, prefilled syringes and intravenous (IV) fluids. Hailing the achievement, Dr Manu Chaudhary, Joint Managing Director, Venus Remedies and Director, Research, Venus Medicine Research Centre (VMRC), said, "This certification is an extended recognition for our manufacturing facilities, which are on a par with international standards in terms of the quality system set by PIC/S member nations. This is the third time that we have got a PIC/S recognition for quality manufacturing standards. Now, all the nine facilities of Venus, eight in Baddi and one in Panchkula, are certified with GMP by the NAFDAC, Ukraine, thereby opening more opportunities for Venus to expand its product portfolio in the remaining PIC/S member countries." With a population of 46.6 million, Ukraine is one of the largest countries in Europe, thus making it a potentially lucrative pharmaceutical market. The pharmaceutical market in Ukraine is expanding at a rapid pace . The US $3 billion market is expected to grow at a compound annual growth rate (CAGR) of 16%. India is the second largest exporter of pharmaceutical products to Ukraine after Germany. According to a research report, 55% of the medicines sold in Ukraine are prescription drugs, while the rest are over-the-counter (OTC) products. Only about a quarter of the drugs consumed in Ukraine are produced domestically, while the rest are imported. "Venus is in the Ukrainian market for the past 11 years. It has been regularly exporting its various oncology products, cephalosporin, carbapenem and other research products and speciality injectables to Ukraine. Today, we have 69 product registrations in Ukraine. In 2012, the total volume of our exports to Ukraine was around US $5 million. We aim to double this figure in the current fiscal year by strengthening our export line in Ukraine," said Dheeraj Aggarwal, Chief Financial Officer (CFO), Venus Remedies Limited. Venus has got 65 market authorisation approvals from the Ukraine authority for its Baddi unit, while 35 applications are in the process. Besides, the Panchkula unit of the company has also been granted four market authorisations and seven are still awaited. ]]> <![CDATA[MSD and Lupin announce Strategic Partnership ]]> https://biospectrumindia.com/news/95/3348/msd-and-lupin-announce-strategic-partnership-.html https://biospectrumindia.com/news/95/3348/msd-and-lupin-announce-strategic-partnership-.html Thu, 18 Jul 2013 15:59:00 +0530 A recent survey from India showed that the case fatality rate due to invasive pneumococcal disease observed in elderly is 26.4% which is much higher than that in children and highlights the demand for preventive interventions in adults. Pneumococcal disease is an infection caused by bacteria named Streptococcus pneumoniae and it leads to variety of invasive and non-invasive pneumococcal diseases. Across the world 1.6 million people die of pneumococcal disease every year whic turns out to be 3 people dying every minute. Adults with co morbid conditions like diabete, chronic heart diseases are more exposed at a greater rate for pneumococcal diseases than health adults.Identifying this profound risk, this collabration is built on a patient centric model, which will improve vaccination rate for pneumococcal disease, specially to target population to lessen incidence and mortality in adults. Mr. K.G. Ananthakrishnan, Managing director, MSD in India, responded on the tie up " It is a perfect amalgamation as MSD brings the reserch and scientific quality for Pneumococcal Polysaccharide vaccines (PPV), and Lupin MSD has a rich legacy of developing vaccines to prevent some of the worlds leading diseases. We are proud to have entered into a strategic, India-specific partnership with Lupin." "We are delighted to be associated with MSD in India. This association bears testimony to Lupin's leadership credentials in the Indian Pharmaceutical Market (IPM), 2.8% market share of the overall IPM (IMS TSA MAT, March 2013). We affirm that the partnesrship is an important step-forward as both companies share a common passion and goal to make a striking difference to the lives of patients in India." ]]> <![CDATA[Cipla India completes takeover of Medpro South Africa]]> https://biospectrumindia.com/news/95/3347/cipla-india-completes-takeover-of-medpro-south-africa.html https://biospectrumindia.com/news/95/3347/cipla-india-completes-takeover-of-medpro-south-africa.html Wed, 17 Jul 2013 15:21:00 +0530 Cipla Limited (Cipla), one of India's prima generic pharmaceutical companies announced that it has completed the acquisition of 100% of the issue shared of Cipla Medpro South Africa Limited, for an aggregate consideration of ZAR 4507 millions (INR 2702 crore). Now known as Cipla Medpro, it is the third largest pharmaceutical company in the country. Founded in 1993, it is a leading provider of chronic medicines to the public and private sectors. The listing of the shares of Medpro on the JSE Ltd has been terminated from the commencement of business on 16th July 2013. "This investment is aligned with Cipla's strategy to ascend the value-chain by managing a front-end sales force in a market outside India. The acquisition intents to further strenghten the Cipla's earnestness to South Africa and the wider African continent. The incorporated business will compete more efficaciously in the dynamic local and global pharmaceutical environments simultaneously there will be an increasing concentration on key African markets." commented Mr. Subhanu Saxena, MD $ Global CEO, Cipla on successful acquisition. Mr.Saxena further expressed " Cipla and Medpro enjoyed a long-standing symbiotic relationship nearly for two decades and the acquisition will fortify Medpro's standing in the South African pharmaceutical market by leveraging Cipla's broad ambit of product portfolio and technological expertise." ]]> <![CDATA[Carestream receives FDA clearance for new technology ]]> https://biospectrumindia.com/news/95/6173/carestream-receives-fda-clearance-for-new-technology-.html https://biospectrumindia.com/news/95/6173/carestream-receives-fda-clearance-for-new-technology-.html Tue, 16 Jul 2013 16:25:00 +0530 Carestream Health, continued its dominance in medical X-ray imaging technology by declaring FDA clearance for a new wireless digital radiography detector designed to offer high quality, low dose X-ray exams for pediatric, orthopaedic and general radiology applications. The new detector is expected to begin shipping in the third quarter of 2013. Helen Titus, Carestream's worldwide X-ray solutions Marketing director told "This smaller detectors can enhance patient care for premature infants in the pediatric ICU. Owing to its size the detector can easily fit underneath the incubator in a small tray, therefore technologist can easily monitor and access the images of these premature babies without moving them." The new DRX 2530C detector can be put in use with any member of the DRX family of room based and mobile imaging sysytems. This flexibility is part of Crestream's commitment to enhance productivity and maximise each healthcare provider's investment in imaging technology. "The new DRX 2530C detector addressed a need voiced by healthcare provides across the globe for a smaller detector that could deliver significant imaging advantages in pediatric and orthopaedic department," said Diana L.Nole, President, Digital Medical Solutions, Carestream. To this she added " We will continue to expand our higly rated DRX imaging systems with new innovations that caters to the inmaging service providers and patients." ]]> <![CDATA[Ranbaxy's Synriam wins ASSOCHAM innovation award]]> https://biospectrumindia.com/news/95/3349/ranbaxys-synriam-wins-assocham-innovation-award.html https://biospectrumindia.com/news/95/3349/ranbaxys-synriam-wins-assocham-innovation-award.html Mon, 15 Jul 2013 16:08:00 +0530 Ranbaxy Laboratories, India's largest pharmaceutical company, on July 14, 2013 announced that it has been conferred with the Innovation Excellence Platinum Award at the ASSOCHAM Innovation Awards 2013 in the Science & Technology category for its new anti-malaria drug, SynriamTM. The prestigious award was given by Minister for Science & Technology and Earth Sciences, S Jaipal Reddy. The objective of the ASSOCHAM Innovation Awards is to identify and bring forward innovative organisations in India who through their innovative actions have launched breakthrough changes and can become role models for others to emulate. India's First New Drug, SynriamTM, was launched by Ranbaxy last year on April 25th (World Malaria Day).The drug is used for the treatment of plasmodium falciparum malaria, in adults. Ranbaxy is working to make this new treatment available in African, Asian and South American markets where Malaria is rampant. The company plans to submit New Drug Applications for market authorisation of SynriamTM in various African countriesin 2013. The company also has plans to extend the benefits of SynriamTM to children in the malaria endemic zones of Asia and Africa. According to the IMS data, over 2 million SynriamTM pills have been sold since its launch and over 700,000 patients have been treated in India. SynriamTM is the new ray of hope to the millions likely to get affected by malaria. The drug is efficacious and has the advantage of "compliance and convenience". The course is one tablet a day for three days and costs Rs 130. Unlike artemisinin-based drugs, it has a synthetic source, the production of which can be scaled up whenever required and a consistent supply of the drug can be maintained at low cost. The drug is also independent of dietary restrictions for fatty foods or milk, as is the case with other anti-malarial therapies. Malaria is a major public health problem in more than 90 countries that host about 40% of the global population. The deadly disease is estimated to cause up to 250 million new infections worldwide every year. Last year, SynriamTM won the Golden Peacock Innovative Product/Service Award. ]]> <![CDATA["Siemens has pioneered the 3rd generation TSH assay"]]> https://biospectrumindia.com/interviews/95/6838/siemens-has-pioneered-the-3rd-generation-tsh-assay.html https://biospectrumindia.com/interviews/95/6838/siemens-has-pioneered-the-3rd-generation-tsh-assay.html Fri, 12 Jul 2013 16:44:00 +0530 With the advent of technology, diagnosis of hormonal diseases has become relatively easier in the last few years. However in the past, thyroid disorders have been confused with other related conditions, with lack of appropriate treatment leading to other disorders such as infertility or stroke. Recently the International Thyroid Awareness Week 2013 from May 25th-31st was celebrated to raise awareness and educate people about the critical role the thyroid gland plays in people's wellbeing. In an email interaction with BioSpectrum, Amol Pandit, business head, Chemistry, Automation and Immunoassay at Siemens Diagnostics talks about Siemens' 3rd generation TSH assay designed to detect and diagnose thyroid dysfunction. Siemens has been a pioneer in introducing the ultra-sensitive 3rd Generation TSH assay, which is available in India since the inception of the diagnostics division of Siemens. 1) In your experience, how prevalent is hyperthyroidism/ hypothyroidism in the Indian population? What are the possible causes for the same? According to the projection from various studies on thyroid disease, it has been estimated that about 42 million people in India suffer from thyroid diseases and about 100 million with sub-clinical (without any clinical symptoms) disease. There is no published data available specifically for hyperthyroidism and hypothyroidism in the Indian population. Notable causes for the same are iodine deficiency and autoimmune disorders. Sometimes surgical removal of the thyroid gland causes hypothyroidism. People are also born without the thyroid gland (condition called Congenital Hypothyroidism). 2) Can you elaborate about the 3rd Generation TSH assay offered by Siemens? How different is it from other tests available in the market? Thyroid-stimulating hormone (TSH) stimulates the thyroid gland to synthesize and secrete thyroid hormone. TSH levels exit the euthyroid reference range in the very early phases of developing thyroid disease, while the patient's condition is still sub-clinical and thyroid hormone levels (T4 and T3) remain within their euthyroid reference ranges. Improvements in the sensitivity of TSH assays allow it to be used for detecting both hyper- and hypothyroidism. Assays with a functional sensitivity of < 0.02 mIU/L are classified as "third generation" assays. To diagnose hyperthyroidism accurately, TSH assay sensitivity, the lowest reliably measured TSH concentration, must be 0.02 mIU/L or less. Some less sensitive TSH assays cannot reliably distinguish patients with hyperthyroidism from those with euthyroidism. Siemens has been the pioneer in introducing the 3rd Generation TSH assay, which is sensitive and precise, with imprecision performance that exceeds the criteria recommended by the NACB for TSH methods. Quantification of circulating levels of TSH using Siemens' 3rd Generation TSH assay can help physicians to: â€¢ detect and monitor thyroid dysfunctionâ€¢ distinguish marked TSH suppression ( < 0.01 Î¼ IU/mL) from sub-clinical hyperthyroidismâ€¢ distinguish true hyperthyroidism from suppressed TSH values in hospitalized patients with non-thyroidal illness (NTI)â€¢ assess severity of hyperthyroidismâ€¢ distinguish Graves' disease from sub-clinical hyperthyroidism or acute NTI 3) Was this assay developed in India? Does the healthcare division of Siemens have an R&D setup in India? This assay was developed in Germany. Yes, Siemens Healthcare has its Corporate Technology research arm in Bangalore and manufacturing unit at Goa, which is also the development center for many X-ray products. 4) Does this assay have any special features in terms of automation or time required? Siemens is known for its Automation and Immunoassay systems that ensure reduced turnaround times, while providing fast and accurate results that further help in timely treatment. The 3rd generation TSH assay runs on high throughput ADVIA Centaur XP/CP immunoassay platforms and the time taken to get the first result is 15 minutes. ]]> <![CDATA[Suven to report research findings on Alzheimer's disease]]> https://biospectrumindia.com/news/95/5254/suven-to-report-research-findings-on-alzheimers-disease.html https://biospectrumindia.com/news/95/5254/suven-to-report-research-findings-on-alzheimers-disease.html Fri, 12 Jul 2013 12:58:00 +0530 Suven Life Sciences has an excellent portfolio of new molecules through four mechanisms of action using 5-HT6, 5-HT4, H3 and Neuronal Nicotinic acetylcholine receptors for the treatment of cognitive impairment in Alzheimer's disease symptomatically but also possibly useful in reducing the disease progression. Suven scientists are presenting pre-clinical and clinical data on these molecule and other NCEs on cognitive impairment and memory related disorders. The company is presenting several exciting new results and data presentations from Suven's portfolio of investigational neuroscience new chemical entities (NCEs) are being presented at Alzheimer's Association International Conference(AAIC) being held in Boston, USA during July 13-18, 2013. AAIC is the world's largest conference of its kind, bringing together researchers from around the world to report and discuss groundbreaking research and information on the cause, diagnosis, treatment and prevention of Alzheimer's disease and related disorders. Alzheimer's disease is one of the scourges of modern day health care which is the largest and fastest growing unmet medical need and Suven is in the forefront of developing a drug for the treatment of this debilitating disease. Alzheimer's is a dementia that causes problems with memory, thinking and behavior. Alzheimer's is not just a memory loss as everyone thinks but Alzheimer's kills. Suven has been focused on discovering, developing and commercializing novel pharmaceutical products, which are first in class or best in class therapies through the use of GPCR targets. The Company has twelve (12) internally-discovered therapeutic drug candidates currently in pre-clinical stage of development targeting conditions such as ADHD, dementia, depression, Huntington's disease and Parkinson's disease in addition to clinical candidate SUVN-502 for Alzheimer's disease and Schizophrenia. ]]> <![CDATA[The journey of Rotavac ]]> https://biospectrumindia.com/news/95/5580/the-journey-of-rotavac-.html https://biospectrumindia.com/news/95/5580/the-journey-of-rotavac-.html Thu, 11 Jul 2013 16:41:00 +0530 With his tireless stint in fostering this partnership and ensuring the highest standards for the vaccine all these years, Dr M K Bhan, former secretary, department of biotechnology (DBT) was highly elated when the official announcement regarding trial results of Rotavac vaccine was made by the DBT and Bharat Biotech, on May 14, 2013 at New Delhi. His belief, what Dr Bhan points out, in the system of the country, kept the efforts multiplying and project expanding. "We must have full faith in our ability to do science and ignore unnecessary criticism. I believe in system and not advocacy," he said while humbly appreciating the international and national partners for their efforts. "Having dealt with poor children my all my life, I have seen how severe is the hospital management and therefore I am happy to see that we would emerge as suppliers of these affordable vaccines for underprivileged." 26 years of striving: A glance at the progress â—„ 1985-86: Dr M K Bhan discovers strain, 116E during his routine testing at All India Institute of Medical Sciences (AIIMS), New Delhi. He partners with Dr Roger Glass, a diarrhoeal expert working then at the CDC's rotavirus laboratory. Around the same time, Dr Durga Dass discovers another strain, l321 at Indian Institute of Science (IISc), Bangalore. He collaborates with Dr Harry Green berg of Stanford University for further research. â—„ 1987: Both the naturally occuring, weakened strains studied by the two independent research teams working parallely under the Indo-US Vaccine Action Programme, bilateral program implemented since 1987 by DBT and NIH. â—„ 2000: Consortium of partners including Bharat Biotech, CDC, NIH, AIIMS, Stanford University, and IISc, submitted a proposal to PATH and DBT for support to move the two vaccine candidates through production, testing and surveillance. â—„ 2003: Partners meet to discuss the clinical studies strategies of the 116E and 1321 vaccine lots. After clearance of protocols for the phase I, first Indian trials began at AIIMS. â—„ 2004-2005: The trial results showed the 116E strain being more effective, providing immunity to 36.6 percent of recipients as compared to 15.4 percent of l321 recipients. On the basis of results, focus was completely put on 116E strain for further development. â—„ 2006: The consortium initiated combined phase Ib/IIa dose escalation study of the 116E vaccine candidate in infants at National Institute of Immunology, Delhi. â—„ 2008: The conclution of Phase Ib/IIa trial showed no identified safety concerns and demonstrated robust immune response in 89 percent of infants. â—„ 2011: The Phase III trials of 116E (now named Rotavac) on 6,799 infants began across three sites in India. â—„ 2013: The data from trial results presented at the international symposium on 'Rotavirus Vaccines for India- The Evidence and the Promise', showed Rotavac to have an excellent safety and efficacy profile. The Indian efforts were led from the front by DBT, AIIMS, IISc equally supported by Translational Health Science and Technology Institute (THSTI) for laboratory testings. While Bharat Biotech invested important technical, manufacturing, and financial resources towards vaccine development, Quintiles was responsible for several aspects of the trial including medical monitoring, data management, site monitoring, pharmacovigilance, and biostatistics. The Good Clinical Practice compliance of the clinical trials was audited by ANTHA Clinical Quality Assurance. Apart from Indian partners, development partnership included the Bill and Melinda Gates Foundation, the Research Council of Norway, and the UK Department for International Development, the US National Institutes of Health (NIH), the US Centers for Disease Control and Prevention (CDC), Stanford University School of Medicine, and the nongovernmental organization, PATH. Now, the positive results have made both the researchers and industry very confident about the indigenous efforts for other vaccine initiatives as well. While Dr Bhan also is of the opinion that it can serve as an inspiring story, the present DBT secretary, Dr K VijayRaghvan, too seems to be in full agreement when he says that this kind of partnership showcases the maturing Indian science and biomedical system. "The success of rotavirus vaccine initiative has added to India's know-how and capacity in ways that will pay dividends for the development of future solutions," added the DBT chief. ]]> <![CDATA[DBT invites suitable ideas on fungi as industrial important products]]> https://biospectrumindia.com/news/95/1568/dbt-invites-suitable-ideas-on-fungi-as-industrial-important-products.html https://biospectrumindia.com/news/95/1568/dbt-invites-suitable-ideas-on-fungi-as-industrial-important-products.html Tue, 09 Jul 2013 11:34:00 +0530 Through this major national network programme on 'Prospecting of Fungi' the department of biotechnology (DBT) would like to capitalize on a treasure of valuable metabolites for industrial important products. For achieving that, the purpose is to establish a network programme involving R&D centers at Universities and Institutes who are interested in prospecting of fungal resources (known and new Fungi) for novel compounds. The specific emphasis should be on bioprospecting of endophytic, thermophilic, marine and coprophilus fungi from different ecological niches. The full length proposals are invited from R&D centres (national laboratories, public institutes, universities etc.) who are interested in prospecting on Fungi of industrial importance. Some indicative priority areas identified but not limited to are bioprospecting of known and new fungi for-industrially important bio-molecules (antibiotics, Pharmaceutical molecules, therapeutic proteins, vitamins, bioinsecticides, biocontrol agents, Foods (neutraceuticals), carotenoids, vitamins, Myco-protein) Industrially important enzymes and enzyme inhibitors, Novel primary and secondary metabolites, Fungal genomics in discovering new biomolecules/drugs, Fungal based biocatalysts to produce pharmaceutical and other industrial products and novel methods to avoid fungal diseases and fungal biosensors In case there is interest in developing a product which has not been listed, that could also be considered, however proper justifications should be provided regarding its national relevance/market potential. The proposals must highlight novelty and strength of existing knowledge, demonstrated proof of concept and expected products/outcomes. If industry is involved, IP sharing between the partners should be clearly spelt out and the percent budget contribution of the industrial partner should be mentioned clearly. The proposals will be examined by constituted expert committee and those which get shortlisted will be intimated for presentation for consideration of financial support by DBT. Interested scientists working in the universities, national laboratories and public institutes can submit their proposal online through DBT eproMIS website (http://dbtepromis.nic.in/login.aspx) under the programme area "National Bio-resource Development Board-Bioprospecting" latest by 16th August, 2013. ]]> <![CDATA[India's first healthcare prepaid card launched]]> https://biospectrumindia.com/news/95/3955/indias-first-healthcare-prepaid-card-launched.html https://biospectrumindia.com/news/95/3955/indias-first-healthcare-prepaid-card-launched.html Mon, 08 Jul 2013 11:38:00 +0530 E-Meditek Global (the holding company of E-Meditek TPA, a leading Third Party Administrator (TPA)), launched India's first healthcare reloadable Pre-Paid Card in partnership with Ratnakar Bank and VISA on July 04, 2013. Medicash Plus offers to its subscribers an Automated discount platform in healthcare services along with many additional complimentary services. Medicash Plus customers will also have access to a host of paid healthcare service platforms which were previously never accessible to retail customers. "MEDICASH PLUS", card co-branded by VISA for retail customers offers three kinds of services to customers:Firstly, it provides discounts in the range of 7% to 40% at various healthcare service providers, such as private doctor's clinics, specialists, diagnostics centers, chemists, dentists & hospitals. This has been made possible by tie-ups that Medicash has made with a network of 1700 such establishments across 23 cities in India. The card is supported by an automated discount platform that instantly credits the committed discount to the cardholder's account without being asked for it while using the card for payment. These network service providers offer services to MediCash Plus Card holders at specially agreed-upon prices. The second bundle of services consists of a host of free services that MediCash customers would enjoy such as complimentary health check-ups, on-call customized dieticians, fitness services, electronic permanent health records, electronic health risk assessment, complimentary medical consultation and even a complimentary stay in a hotel for one night. These complimentary services have been meticulously handpicked to provide a world-class experience to Indian customers. The third set of services that Medicash card will offer includes paid services, which were previously only available to corporate customers (such as paid concierge customers, on-road car assist, doctor on chat, etc.) Further, the MediCash Plus card can be customized to the various needs of corporate engagement so that employees and customers can be provided with various medical, non-medical and concierge benefits. Thus, apart from making quality healthcare available at an affordable price, MediCash Plus can also be seen as a contrivance that simplifies and adds convenience to life. To assist in serving the unique benefits that this product offers, the card is available in five unique variants to cater to a multitude of consumer segments; the variants being Classic, Silver, Gold, Platinum and Signature. Having successfully launched the "MediCash" Card for the customers of L & T General Insurance (a card that offers Real Time on-the-spot Cashless Approvals before hospitalization), this Card is yet another product in association with Ratnakar Bank and VISA: "MediCash Plus", as the card serves as 'Your Health Savings Account". The company has created an integrated network of medical service providers that include private clinics, specialists, diagnostic centers, hospitals, chemists, gyms, spas, beauty salons, lifestyle centers and restaurants. While addressing the media at the launch of the pre-paid Medicash Plus Card, Mr Gopal Verma, Chairman, E-Meditak Global said, "We are proud to launch India's first Healthcare prepaid Card as we bundle a host of Managed Care and Concierge Services. This card not only redefines the way one saves money, it also increases convenience when one needs assistance the most: be it sickness at midnight, admission into a hospital, online search, appointment with doctors, emergency medical evacuation, access to your old medical record or road side assistance. The list just does not end, there are many other services, online support and access to critical information that is designed to suit every individual and family. Whether one calls us or connects to us online, we are available round-the-clock to ensure that our cardholders get the privilege the MediCash Plus Card offers." We have collaborated with numerous medical and non-medical service providers that include private clinic doctors and specialists, diagnostics centers, chemists and dentists to bring to our cardholders services and privileges at highly discounted and specially agreed-upon prices. Additionally the network includes several gyms, spas, beauty salons, lifestyle centers and restaurants. The usage of this Pre-paid Card is not restricted to usage at our integrated network. This card can be used at any VISA merchant similar to a normal credit or debit card transaction. These services are unheard of for retail customers. MediCash Plus for corporate has the flexibility to integrate a plethora of services e.g. management of domiciliary treatment expenses, meal coupons, office canteen use etc. You name it and it will be done for you while maximizing the worth of the amount loaded on your card. As per Mr Rajeev Ahuja, head, Strategy and Financial Markets, "We are confident that this will define the way health care payments are made in the near future and help bring a lot of ease, convenience, efficiency and speed in the entire transaction cycle. Also, it's a win-win situation for all the entities involved in offering this service since it brings value to all stakeholders. Our Bank's emphasis has always been to develop/partner-in launching such innovative payment products. Prepaid card offering has been one of our focus area and we hope to create a difference by constantly bringing new products/ payment opportunities in the future as well." E-Meditek Global started operations in 2005. The company was established with the objective of creating a firm financial ecosystem in the Indian Healthcare Industry. E-Meditek Global is a holding company of E-Meditek Group, which includes E-Meditek Technology, E-Meditek Wellness, E-Meditek Assist and E-Meditek TPA. The core focus of E-Meditek Global is to improve the payment mechanism in healthcare financing system ensuring quality healthcare treatment at affordable price by adding to convenience of end users. ]]> <![CDATA[Venus bags Japanese patent for Elores, an antibiotic to fight superbugs]]> https://biospectrumindia.com/news/95/6839/venus-bags-japanese-patent-for-elores-an-antibiotic-to-fight-superbugs.html https://biospectrumindia.com/news/95/6839/venus-bags-japanese-patent-for-elores-an-antibiotic-to-fight-superbugs.html Mon, 08 Jul 2013 10:23:00 +0530 Venus Medicine Research Centre (VMRC), the R&D wing of Venus Remedies, a research-based global pharmaceutical company, has been granted a patent for Elores, an antibiotic found effective against carbapenemase-resistant enterococci bacteria, by the Japanese Patent Office. The company is expected to launch this product in Japan, the world's second largest pharmaceutical market next to the US, by the end of 2015. Elores, which was launched in the Indian market in January this year, has received tremendous response from the medical fraternity. It has a unique profile of action which gives it an edge over all the existing therapies. "This unique antibiotic adjuvant entity creates a synergistic effect due to its activity on multi-drug resistant extended spectrum beta lactamase and metallo beta lactamase (ESBL/MBL) producing gram negative bacteria. It prevents the development as well as the spread of bacterial resistance from one species to another. Clinical studies on more than 1,000 patients have indicated an over 30% reduction in cost of therapy as compared to conventional therapies," said Dr Manu Chaudhary, Joint Managing Director, Venus Remedies and Director (Research), VMRC. Elores was recently recognised as the best innovation of 2013 by a team of experts from Stanford Business School, US, IC2 University of Texas, Austin, US and Lockheed Martin Foundation in collaboration with the union department of science and technology under the Indo-US joint science and technology innovation programme, 2013. It has also been selected among the top eight technologies to be commercialised in the USA. Emerging anti-microbial resistance has become a grave problem worldwide, as evident from the recent statement of UK's chief medical officer that anti-microbial resistance was as important an issue as terrorism. "Elores is a product with proven potential. The Japanese patent has given us exclusivity for the product in one of the world's most important and lucrative healthcare markets up to 2025. Venus has already filed the common technical document with the European Union (EU) and is on the verge of getting MA grant for the product. Since EU and Japan have an understanding on the regulatory front, the product can be made available in the Japanese market within no time after receiving the MA grant from EU," said Dr Chaudhary. Venus has received patents for this product from 46 countries, including the US, Australia, New Zealand, Russia, South Africa, South Korea, India and all major economies, including EU constituents. "We expect this product to generate a revenue of around $100 million by 2018. The innovation assumes greater significance at a time when the medical community the world over is looking for ways to deal with the growing problem of antibiotic resistance. Drug-resistant microbes could well become a threat to human race in days to come as an increasing number of antibiotics are feared to be losing out in the battle. There are far fewer new antibiotics in the development pipeline as global drug manufacturers are focusing more on drug candidates with instant blockbuster potential to treat cancer and metabolic diseases. In this complicated scenario, a drug like Elores will prove a boon for the society," said Dheeraj Agrawal, chief financial officer (CFO), Venus Remedies. Regulatory agencies around the world are currently fast-tracking the approval process of antibiotic drugs. Moreover, the company is assisted by experts from IC2 Texas to get the product fast-track approval under the GAIN (Generating Antibiotics Incentives Now) Act, a legislation recently passed by the US government. The first plasmid-mediated MBL was reported in Pseudomonas aeruginosa in Japan in 1991. In a very short time, MBLs became more frequent and are now widespread. From an isolated study, it has been established that more than 19% nosocomial infections in Japanese ICUs are ESBL-positive, thus creating a compelling need for a product like Elores. Globally, the antibiotics market generated sales of US $42 billion in 2009, representing 46% of sales of anti-infective agents (which also include antiviral drugs and vaccines) and 5% of the global pharmaceutical market. However, the antibiotics market is maturing. It recorded an average annual growth of 4% over the past five years, out of which the US alone accounted for 35% of the market share ($12 billion), followed by Japan ($10.5 billion). Elores directly addresses a market of US $4 billion against the closest contested competitors category. ]]> <![CDATA[Diabetic patients taking pioglitazone need not panic about any risks, say city Doctors]]> https://biospectrumindia.com/news/95/3329/diabetic-patients-taking-pioglitazone-need-not-panic-about-any-risks-say-city-doctors.html https://biospectrumindia.com/news/95/3329/diabetic-patients-taking-pioglitazone-need-not-panic-about-any-risks-say-city-doctors.html Sun, 07 Jul 2013 19:45:00 +0530 Concerned with frequent diabetic patient queries after the ban on pioglitazone announced last week, leading physicians and diabetes experts from the city came together to allay patient concerns. Over 30 lakh patients across India were using pioglitazone medication. The Doctors sought to allay patient fears about pioglitazone usage, as the drug is currently used in all countries including USA, UK, Japan, etc. except France where it was gradually phased out. The meet was addressed by renowned Doctors including Dr. Vijay Panikar, Dr. Siddharth Shah and Dr. Rajiv Kovil. The Doctors expressed confidence that the authrorities will review pioglitazone ban once more clinical data is submitted to them. Affordability for the masses and lack of absolute susbstitute with similar efficacy are two favourable considerations for the drug. Pioglitazone is the 2nd/ 3rd line of treatment for Type 2 diabetes and is one of the commonly prescribed medicines for the treatment. With the ban on the drug, concerned patients are increasingly reaching out to their doctors to seek treatment advice. Dr Siddharth Shah initiated the conversation and mentioned that the drug is a beautiful drug. He said, "There are more than 60 million diabetics in India, with more than 95% being type II diabetes patients. For such patients, insulin resistance is a major complication. Lifestyle modification can help only 20% of these patients; others need medication. Pioglitazone allows the internal insulin to work in the body and has its own capacity to reduce glucose. Every drug has side effects; doctors are aware of the patient history and risk factors and are then prescribing the drug. The low cost of the drug is a huge factor to consider too." While mentioning the reason why the drug is popular Dr Vijay Panikar asserts, "Indians/Asians are made up of different phenotypes and genotypes. We are more inclined to have type II diabetes. Considering all this, pioglitazone is the only drug that can act on the insulin resistance problem of Indians. Literature has an equal share of reports mentioning the harmful and beneficial effects of pioglitazone, and doctors are astutely prescribing the drug after understanding the benefits and risks involved. Pioglitazone is a good molecule when used rationally. The government should reconsider the decision for this molecule and add more contraindications for the use of this drug. Cost of alternatives available would be a major factor for several hospitals and society." While talking about the safety and efficacy issues of the drug, Dr Kovil stressed on the judicious prescribing of the drug. He mentioned that, "Considering the patient profile before prescribing this drug is very important. Regulatory authorities such as EMEA and US FDA too have approved the drug, while mentioning that patients with risk/history of bladder cancer should not be taking this drug. Similarly, it should be noted that pioglitazone has several other benefits such as reducing cholesterol levels and acting as an inflammatory marker. All factors should be considered and the drug should be prescribed wisely." ]]> <![CDATA[Immunization coverage increases substantially ]]> https://biospectrumindia.com/news/95/3330/immunization-coverage-increases-substantially-.html https://biospectrumindia.com/news/95/3330/immunization-coverage-increases-substantially-.html Sun, 07 Jul 2013 19:35:00 +0530 There is continuous expansion of immunization activities in the country. Hepatitis-B vaccine has been included in the Universal Immunization Programme recently. Japanese Encephalitis vaccination is being undertaken in 175 identified districts, with 62 new districts being added to the existing 113 in 19 states. Pentavalent Vaccine containing DPT, Hepatitis-B and Hib vaccines was started in two states of Kerala and Tamil Nadu from December 2011. This was stated by Mr Ghulam Nabi Azad, union minister of health and family welfare at Chandigarh on July 08, 2013. Addressing the Golden Jubilee Celebrations & Foundation Day of Post Graduate Institute of Medical Education and Research, Chandigarh, Shri Azad said PGIMER owes its inception to the vision of late Sardar Partap Singh Kairon, the then Chief Minister of Punjab and the distinguished medical educationists supported by the first Prime Minister of India Pandit Jawahar Lal Nehru who considered the institutions of scientific knowledge as temples of learning and places of pilgrimage. Over the years, PGIMER has fulfilled its mandate and gained reputation for providing the highest standards of clinical care. "In-principle approval has been given to PGIMER to develop a 300-bed satellite centre at Sangrur which could be expanded to a 500 bed facility depending upon the case load. A 100-bed satellite centre will also be set up at Ferozepur to provide quality tertiary care to the people living in remote areas," mentioned the health minister. Azad said the last 4 years have been a new era of reforms in the history of medical education of India. The availability of MBBS seats has gone up from 33,567 to 45,629 and the number of PG seats increased from 13,838 to 22,850. 72 new medical colleges including six new AIIMS at Bhopal, Bhubaneswar, Jodhpur, Patna, Raipur and Rishikesh have been established raising the number from 290 to 362. "To overcome the shortage of Nurses and ANMs, Government of India has sanctioned 269 nursing schools in the last two years, mostly in remote, inaccessible and under-served districts. With an estimated outlay of Rs. 2,030 crores, these institutions will give nearly 20,000 additional nurses annually. To give a boost to para-medical education and scale up the availability of para-medics, a National Institute of Paramedical Sciences (NIPS) at Delhi and 8 Regional Institutes are being established. A total of 10,760 paramedic professionals are expected to be trained annually when these institutes of excellence are fully functional," mentioned the union health minister. ]]> <![CDATA[Merck and Greenpharma collaborate on cosmetic active ingredient]]> https://biospectrumindia.com/news/95/7712/merck-and-greenpharma-collaborate-on-cosmetic-active-ingredient.html https://biospectrumindia.com/news/95/7712/merck-and-greenpharma-collaborate-on-cosmetic-active-ingredient.html Fri, 05 Jul 2013 16:44:00 +0530 Recently Merck announced the signing of an agreement with Greenpharma S.A.S. (OrlÃ©ans, France) for its cosmetic active ingredient poppy seed extract. According to the agreement, Merck will market the active ingredient globally under its umbrella brand RonaCare® as of September. In addition, Merck is responsible for sales, logistics and application technology customer support. Poppy seed extract is a skin-firming substance with a dual mechanism of action. Michael Weiden, Head of Functional Materials within the Pigments & Cosmetics business unit, explains: "We are a leading manufacturer of cosmetic ingredients and the course clearly continues to be set for growth in this area. We will continue to augment our innovative portfolio derived from in-house research and development by cooperating with external partners. Compliance with Merck quality standards is a most important precondition. Greenpharma distinguishes itself by high quality standards, intensive research work and environmentally sound product manufacturing. That makes it a perfect partner for Merck." Natural poppy seed extract displays lipolytic activity via a dual mechanism: both by inhibiting lipogenesis and by activating lipolysis. The researchers at Greenpharma proved that the active ingredient inhibits the build-up of fat by reducing G3PDH activity (glycerol-3-phosphate dehydrogenase) in the fat cells. At the same time, it activates lipolysis by enhancing the release of free fatty acids. As a result, poppy seed extract is particularly suited for use in anti-cellulite body care products. The skin-firming effect of the substance can also be put to use in other applications, for instance to give facial skin a smoother and more even appearance."We are proud to serve our partner Merck as an innovative provider of R&D solutions. This agreement does illustrate Greenpharma's capability to conduct R&D projects from a robust scientific basis to an active ingredient ready for the market", declared Philippe Bernard, Chief Executive Officer of Greenpharma. Further, the company also offers functional fillers and effect pigments for color cosmetics and skin care products. In particular, effect pigments are used in many cosmetic products in order to provide color, luster, gloss and other effects. ]]> <![CDATA[Mylan consolidates its leadership position in HIV diagnostics]]> https://biospectrumindia.com/news/95/5233/mylan-consolidates-its-leadership-position-in-hiv-diagnostics.html https://biospectrumindia.com/news/95/5233/mylan-consolidates-its-leadership-position-in-hiv-diagnostics.html Wed, 03 Jul 2013 14:41:00 +0530 Mylan Inc on July 2, 2013 announced that it has entered into an exclusive agreement with Zyomyx, Inc. for the rights to distribute Zyomyx's proprietary point-of-care (POC) CD4 T-cell count test in the developing world. CD4 count testing is a critical diagnostic component in treating HIV/AIDS, as medical professionals refer to a patient's CD4 count to determine when to begin and/or alter HIV treatment. As part of the agreement, Mylan also has made a strategic equity investment in Zyomyx. The Zyomyx POC CD4 test is currently in final stages of development and expected to launch in the near-term, pending applicable regulatory approvals. Mylan expects to distribute the portable, easy-to-use, low-cost test in the developing world alongside its broad portfolio of high quality, affordable generic antiretroviral (ARV) drugs in order to improve access to and guide HIV/AIDS treatment in resource-limited settings. To complement the exclusive agreement with Zyomyx, Mylan also announced that it has signed a Global Access Commitment with the Bill & Melinda Gates Foundation, an investor in Zyomyx. Mylan has committed to ensuring that the Zyomyx POC CD4 technology can be made available and accessible at a reasonable price in high burden HIV countries. Increasing access to affordable and effective health interventions for those in need is a priority for the foundation. Mylan CEO Heather Bresch commented, "Mylan's mission is to set new standards in health care and provide the world's 7 billion people access to high quality medicine. We expect that this distribution agreement with Zyomyx and our collaboration with the Bill and Melinda Gates Foundation will be a true game changer in improving access to treatment of HIV in the developing world by enabling rapid, low-cost testing of patients in any location, however remote, thereby ensuring immediate enrollment on treatment. Further, this distribution agreement and investment represents Mylan's entry into diagnostics as we strive to meet the evolving needs of our customers and patients. It will transform Mylan from a leading provider of HIV treatments to a leading provider of HIV health care solutions, which will continue to differentiate Mylan in this important area." Rajiv Malik, Mylan's president, added, "Zyomyx's CD4 test is a revolutionary technology that couldn't come at a better time. The World Health Organization's revised antiretroviral treatment guidelines increase the number of people living with HIV and eligible for treatment to close to 26 million, and pregnant women are now advised to start treatment as soon as they test positive. The more quickly patients can receive CD4 testing, the more quickly they can access life-saving medicine. Mylan's investment in Zyomyx is just one step in our efforts to support the goal of universal access to HIV/AIDS treatment." Trevor Mundel, president of Global Health at the Bill & Melinda Gates Foundation, said, "HIV patients in the developing world have long faced considerable challenges accessing CD4 testing due to the poor availability of testing in rural areas, the challenges of travel to testing sites and the cost of the tests. Mylan's investment in Zyomyx and collaboration with the foundation will potentially greatly enhance access to testing and treatment in the developing world." The Zyomyx CD4 count test, the first product developed using Zyomyx's breakthrough diagnostic platform, is easy-to-use and the fastest yet, providing results in less than 10 minutes with minimal training. The test is portable and disposable - small enough to fit into a back-pack and requiring no grounded electricity - making it ideal for use in developing markets and rural settings. Importantly, the test is highly accurate and has proven to be equivalent in accuracy to flow cytometry, the current gold standard in CD4 count testing. Peter Wagner, president and CEO of Zyomyx, said, "As a diagnostics company, we are excited about the potential impact of this agreement with Mylan, a pharmaceutical company that has access to nearly every HIV/AIDS treatment clinic in Africa through its impressive distribution network. Together, we will be able to ensure that people living with HIV/AIDS in the highest burden countries receive both the testing and lifesaving treatment they need." Mylan has been a leading global player in the HIV/AIDS arena for more than a decade and a leader in bringing to market innovations that enhance access to treatment, for instance producing fixed dose combinations, which provide a reduced pill burden and once-a-day dosage, and patient-convenient "combo" packs. Mylan also developed multiple FDA/WHO-approved heat-stable ARV products, which can be distributed and used in warm climates where refrigeration infrastructure is not widely available. In addition, Mylan has been a global leader in producing ARV formulations for pediatric use. Today, Mylan supplies high quality ARVs to more than 120 countries around the world and nearly 40% of HIV/AIDS patients receiving treatment in developing countries depend on one of the company's ARV products. Under the terms of the distribution and supply agreement, Zyomyx will supply the POC CD4 test to Mylan, and Mylan will pay development and commercial milestones and a share of profits to Zyomyx for the exclusive rights to distribute the POC CD4 test in Africa; Asia (excluding Japan and South Korea but including (without limitation) Russia, Central Asia and the Middle East); CEE; CIS; South America and Central America (including Mexico); and the Caribbean Islands. Further, simultaneous with the execution of the distribution and supply agreement, Mylan made a strategic equity investment in Zyomyx and entered into an agreement with the Bill & Melinda Gates Foundation to provide improved and affordable CD4 testing access to patients in high burden HIV countries. All other terms of the agreements are confidential.This press release includes statements that constitute "forward-looking statements," including with regard to the distribution and supply agreement. These statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Because such statements inherently involve risks and uncertainties, actual future results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to: the impact of competition; failure to achieve anticipated sales; changes in economic and financial conditions of the company's business; uncertainties and matters beyond the control of management; and the other risks detailed in the company's periodic filings with the Securities and Exchange Commission. The company undertakes no obligation to update these statements for revisions or changes after the date of this release. ]]> <![CDATA[Jairam Ramesh does it again, curses GM crops as a ploy to monopolize agriculture]]> https://biospectrumindia.com/news/95/7411/jairam-ramesh-does-it-again-curses-gm-crops-as-a-ploy-to-monopolize-agriculture.html https://biospectrumindia.com/news/95/7411/jairam-ramesh-does-it-again-curses-gm-crops-as-a-ploy-to-monopolize-agriculture.html Tue, 02 Jul 2013 13:17:00 +0530 While speaking recently at an event to launch 'Lancet Series on Maternal and Child Nutrition', the rural development minister, Jairam Ramesh warned against opting for genetically modified (GM) food crops in the name of providing better nutrition. "The step from recognising the importance of agriculture in nutrition to making a case for genetically engineered GM crops is a very small step. Because it is very mesmerising and very seductive to have rice which is fortified with vitamin A, a wheat which is fortified with iron and all the wonderful things that have come out with through transgenetic techniques," he added while speaking at the vent held in New Delhi. Ramesh, who as environment minister oversaw a massive public consultation on genetically modified or Bt Brinjal, mentioned that while the first green revolution which was publicly funded and delivered saw the wheat and rice varieties coming from Cimmyt in Mexico and Iri in Philippines respectively, today's crop varieties are not coming from Monsanto and Syngenta - the two major sponsors of GM foods. It was during his stint as environment minister in 2010, that a moratorium on Bt Brinjal. His move was well lauded by the environmental activists and those against the GM crops. However, he has been equally criticized by top scientists and his colleagues within the government for over-ruling the scientific fraternity. The comments from Ramesh have come at a time when come the Genetic Engineering Appraisal Committee (GEAC), the statutory body on genetically modified crops, recently allowed field trials for four food crops-- genetically modified rice, wheat, maize and castor. However it was said that the the minutes of the relevant GEAC meeting which were inadvertently put on the GEAC site were not approved by the environment ministry and therefore take off later. Also, the ministry, which has the final say put the decision on hold in wake of the ongoing case in the Supreme Court on GM crops. The hearing in that case is expected to happen today on July 2, 2013. With the strategies drawn and argument ready on both sides, it would be interesting to see what the court decides to do. ]]> <![CDATA[Strengthening of multi-disciplinary research units during the 12th Plan period ]]> https://biospectrumindia.com/news/95/1170/strengthening-of-multi-disciplinary-research-units-during-the-12th-plan-period-.html https://biospectrumindia.com/news/95/1170/strengthening-of-multi-disciplinary-research-units-during-the-12th-plan-period-.html Mon, 01 Jul 2013 17:20:00 +0530 The cabinet committee on economic affairs (CCEA) has approved the proposal of the department of health research in the ministry of health and family welfare for the setting up of multi-disciplinary research units (MDRUs) in 80 government medical colleges at an estimated cost of about Rs 503.85 crore, during the 12th plan period. Of these, 35 units will be established in 2013-14 and 45 in 2014-15. The measure will encourage and strengthen an environment of research in government medical colleges and bridge the gap in infrastructure which is inhibiting health research in medical colleges. This will improve the health status of the population by creating evidence based application of diagnostic procedures, processes and methods. One time financial assistance upto Rs 5.25 crore will be provided to each government medical college/institution for setting up of a modern biological lab/multi-disciplinary research unit. This will include Rs.5 crore towards equipment and Rs.25 lakh for minor civil works for modifications/renovation in the space to be provided by the state medical college. In addition, financial assistance of Rs.19.23 lakh per annum for meeting recurring expenditure towards staff and Rs.15 lakh per annum towards consumables/training/contingencies will also be provided for a period of five years to each medical college/institution. The state Government will be required to provide requisite space (free of cost) for establishment of MDRUs in medical colleges and will also be required to take over the recurring expenditure liability of the labs after the project period of five years. While research should have been the integral activity of medical colleges, a majority of medical colleges have confined themselves to routine patient care and are not pursuing newer methods of investigation for understanding pathological diagnosis, treatment and management practices. This is due to both lack of appropriate facilities for conducting research and lack of motivation on the part of faculty and students in medical colleges for conducting research. ]]> <![CDATA[India and Vietnam to collaborate in various biotech research areas]]> https://biospectrumindia.com/news/95/1079/india-and-vietnam-to-collaborate-in-various-biotech-research-areas.html https://biospectrumindia.com/news/95/1079/india-and-vietnam-to-collaborate-in-various-biotech-research-areas.html Mon, 01 Jul 2013 15:50:00 +0530 The department of biotechnology (DBT), government of India and ministry of science and technology (MOST), socialist republic of Vietnam has announced a joint call for collaborative proposals to support medical, environmental and agricultural biotechnology (including animal and aquaculture) research. The project period shall be 24 to 36 months. The complete details for submission of collaborative project proposals can be sent latest by July 31, 2013. The purpose of the call is to build on the combined strengths of academic research groups within India and Vietnam, to work together on collaborative multi-disciplinary research in the areas mentioned below: i. Agriculture Biotechnology-Marker assisted breeding for agronomically important traits in crop plants with special reference to rice; Isolation, characterization and functional validation of novel genes/promoters for agronomically important traits in crop plants; Application of biotechnology in plant genetic resource management. ii. Medical Biotechnology-Development of in vitro molecular diagnostic assays for various infectious and non-infectious diseases of relevance to India and Vietnam;Development of vaccines for various infectious diseases including technology transfer for coproduction in both the countries;Evaluation of bioactive compounds from plants/microbes for their application. iii. Animal Biotechnology (including Aquaculture)-Improved vaccines and molecular methods of diagnosis for animal and poultry diseases including nano delivery systems; Innate immunity analysis of native breeds of animals and chickens to identify their disease resistance characteristics; Application of biotechnology in animal genetic conservation. iv. Environmental and Industrial Biotechnology-Application of biotechnology in food processing/industry; application of biotechnology for environment protection/ biofertilizer production. ]]> <![CDATA[Govt to establish network of laboratories for epidemics and natural calamities ]]> https://biospectrumindia.com/news/95/4120/govt-to-establish-network-of-laboratories-for-epidemics-and-natural-calamities-.html https://biospectrumindia.com/news/95/4120/govt-to-establish-network-of-laboratories-for-epidemics-and-natural-calamities-.html Mon, 01 Jul 2013 15:32:00 +0530 The cabinet committee on economic affairs (CCEA) on June 28, 2013 approved the proposal of the department of h/ealth Research under the Ministry of Health and Family Welfare for the setting up of 10 regional labs, 30 state level labs and 120 medical college level labs under the scheme for establishing a network of laboratories for managing epidemics and natural calamities. The scheme is estimated to cost Rs 646.83 crore during the 12th Five Year Plan. The expenditure on the establishment of the labs at the State level and at medical colleges would be shared between the Central Government and State Governments in the ratio of 75:25 (90:10 in North-Eastern, Hill States, including Sikkim and Jammu and Kashmir). Expenditure on the regional labs would be fully borne by the Central Government. This major initiative taken by the Government for establishment of a 3-tier network of laboratories across the country will greatly help in building capacity for handling viral diseases in terms of early and timely diagnosis, development of tools to predict viral disease outbreaks beforehand, continuous monitoring and surveillance of existing as well as new viral strains and handling viruses with a potential to be used as agents of bio-terrorism. The initiative shall also help in smooth data flow from across sites of epidemics, creation of efficient knowledge management network for policy interventions such as quick deployment of resources and measures like introduction of preventive strategies, new vaccines, etc. Currently only national apex institutes like NCDC, New Delhi and NIV, Pune are mandated to undertake investigations. This leads to creating a heavy burden and affect their real referral role. The resultant delay in diagnosis/detection and inadequate/incomplete data during outbreaks significantly impacts on response time for interventions. The regional labs will be equipped with state of the art BSL-3 facilities and the State level labs will have BSL-2 facilities. The lowest tier labs at medical colleges will be equipped with appropriate infrastructure to carry out serology for viruses (ELISA based diagnosis). In case of any outbreak / epidemic, these medical college level labs will carry out the initial diagnosis/ screening at the most peripheral areas nearest to the site of the outbreak. Each medical college lab will cover a cluster of three to four districts. While medical college labs will be expected to identify all listed common viruses, the viruses/agents which cannot be identified by these labs will be referred to the State/regional labs for identification and / or characterization. All the laboratories will work under the overall guidance of apex institutions like NIV and NCDC through appropriate linkages and networking. The States/UTs which do not currently have any government medical colleges will be linked with the nearby State`s laboratories. ]]> <![CDATA[Kashmir gets back its CSIR-IIIM laboratory ]]> https://biospectrumindia.com/news/95/5429/kashmir-gets-back-its-csir-iiim-laboratory-.html https://biospectrumindia.com/news/95/5429/kashmir-gets-back-its-csir-iiim-laboratory-.html Mon, 01 Jul 2013 12:40:00 +0530 The union science and technology and earth sciences minister, S.Jaipal Reddy on June 30, 2013, rededicated the branch Laboratory of CSIR-Indian Institute of Integrative Medicine (CSIR-IIIM) at Srinagar. Present on the occasion were Mr Omar Abdullah, chief minister of Jammu and Kashmir, Mr Feroz Ahmad Khan, minister of science and technology, govt of J&K and senior officers from the Council of Scientific & Industrial Research (CSIR) and IIIM. Speaking on the occasion Mr Jaipal Reddy said he is pleased to see the world class scientific infrastructure being created for globally competitive scientific research relevant to the economic development of J&K state and the country. With the rejuvenation of this lab, it is attracting top class talent from all over the world. CSIR played a significant role in the development of Science and Technology in the country. He Said that J&K has been taken care of very well by CSIR in doing so. Reddy said his ministry supports the initiatives taken by CSIR-IIIM to create an innovation system for employment and wealth generation. He said as presented to him, this laboratory has made major societal and scientific contributions to the economy of the State of J&K and India. The minister said he would like to announce: 1. Establishment of of Industrial Biotech Parks with the participation and support of Deptt. Of Bio-Technology (DBT), CSIR 2. Technical & strategic support for realizing the full potential of the growth of unique Aroma Industry in the J&K state; 3. Establishment of world class "CSIR Science Center" at IIIM, Srinagar Branch Laboratory including a value-addition center for aroma industry, a state-of-the-art leather-design center, marketing-networking facilities and a Science Museum for children of the Kashmir valley; and 4.Creation of A New Research Centre in the Ladakh region of J&K with the support of CSIR-IIIM to tap the talent and potential of young ones from the Leh and Kargil districts of the region; and 5. Initiation of major Human-Resource Development programmes for the youth of Jammu & Kashmir state, under the umbrella of newly created Academy of Scientific and Innovative Research (AcSIR). Mr Reddy appreciated the amount of interest taken by Mr Omar Abdullah in the scientific development in the Jammu & Kashmir state to tap the potential of unique biodiversity of this state for rural prosperity and employment generation. He also appreciated the remarkably high interest in science among the youth of J&K and said it is incumbent on governments to provide necessary state-of-the-art lab facilities to fructify their yearnings. He also thanked the Chief Minister for engaging CSIR-IIIM in a meaningful way towards fulfilling these objectives. He also asked DG,CSIR and Director, CSIR-IIIM to carry forward these initiatives, which are of critical importance to the development of J&K State. The CSIR-IIIM Laboratory which has made major societal and scientific contributions to the economy of the State of J&K and India has an illustrious past since its inception in 1942 by legendary medical scientist Col. Sir Ram Nath Chopra. This Srinagar based laboratory is reported to have suffered major decline in the decade of 1990s and 2000s due to the disturbed conditions in the Valley. The process of rebuilding scientific labs / facilities of this centre started in 2009 with major efforts on the part of DG,CSIR and Director, CSIR-IIIM. Chief minister of state, Omar Abdullah said we have to work for developing scientific infrastructure and laboratories in colleges and schools to produce competitive children. He said we need to ensure the practical application of research as far as possible and to create an opportunity for its actual application in areas like Agriculture.He said it is a challenge for us to convince the famers for a shift from conventional cultivation to the cultivation of cash crops. He gratitude for the announcements made by Shri Reddy and hoped that these initiatives will lead to the overall growth of the state and will usher to a great extent in the development of scientific temperament of the youn population of the state. The welcome address was made by Dr Ram Vishwakarma, director, IIIM Jammu who also gave a presentation about the role of the institute while Dr Samir K. Bramhachari, DG, CSIR and secretary CSIR mentioned the efforts of CSIR in this connection. ]]> <![CDATA[Philips unveils products to reduce infant mortality in India]]> https://biospectrumindia.com/news/95/6801/philips-unveils-products-to-reduce-infant-mortality-in-india.html https://biospectrumindia.com/news/95/6801/philips-unveils-products-to-reduce-infant-mortality-in-india.html Thu, 27 Jun 2013 15:34:00 +0530 Philips Innovation Campus (PIC), Bangalore, continues its quest to provide innovative and affordable healthcare solutions for India. The company on June 27, 2013, launched an innovative and advanced suite of mother and child care solutions during the Annual Media Onsite, 2013. This suite of products focused across the continuum of care is affordable and caters to a diverse set of care areas. "India loses over three lakh babies every year. Many of these are premature and low birth weight infants who are exposed to hypothermia - a condition where the infants' body temperature drops below the normal temperature required for metabolism and body function. The Philips Efficia range of infant Warmers and Incubators are intended to reduce infant mortality which is the need of the hour in India. Other major causes for infant mortality are neonatal jaundice and respiratory distress, which are addressed by products such as BiliChek ® transcutaneous bilirubinometer, BiliTxTM phototherapy system and NeoPAP respiratory support solution for neonates" said Dr Wido Menhardt, CEO, Philips innovation Campus. "The launch today is in line with our commitment to focus on next generation healthcare solutions. We believe that this whole new suite of products launched today will provide value to customers through cost effective solutions and greater efficiencies. We have solutions for premium urban corporate hospitals as well as tier-2 cities and primary health centers." said Krishnakumar, President - Philips Healthcare India. It is also important to monitor the bilirubin levels in infants since neonatal jaundice is common in newborn babies, affecting nearly half of them in the first two weeks of life. The Philips BiliChek ® measures bilirubin levels in a non-invasive manner making use of light instead of a needle, reducing pain and trauma to the babies. The most convenient aspect of BiliChek ® is that, it can be utilized without the hassles of undergoing a lab test and waiting for results. BiliTXTM wraps babies in healing light. Neonatal jaundice can be effectively treated through phototherapy, and, Philips through its global expertise in healthcare and lighting is focused on developing products that support the infant's development and the health of the mother. With NeoPAP Philips provides a sophisticated neonatal CPAP (Continuous Positive Airway Pressure) delivery system, developed to treat newborns and infants with Respiratory Distress Syndrome (RDS). This non-invasive, dynamic system features a lightweight interface made of soft, skin-friendly silicone to ensure patient comfort and safety. Philips Innovation Campus, whose vision is to create innovative and meaningful healthcare solutions for the community, with focus on constantly improving patient care, believes that this launch will provide easy access and efficient healthcare for all. ]]> <![CDATA[Stopping polio to make a comeback ]]> https://biospectrumindia.com/news/95/4786/stopping-polio-to-make-a-comeback-.html https://biospectrumindia.com/news/95/4786/stopping-polio-to-make-a-comeback-.html Thu, 27 Jun 2013 15:09:00 +0530 Rotary International and the Bill and Melinda Gates Foundation (BMGF) have joined hands to address the funding gap in the new strategic plan announced by Global Polio Eradication Initiative (GPEI) towards Polio Eradication. Considering the projected cost of USD 5.5 billion in the 6 years GPEI '2013-2018 Strategic plan' against Polio, BMGF has announced to contribute twice the amount raised by Rotary International, one of the spearheading partners of the GPEI. Rotary and the Gates Foundation are determined not to let polio make a comeback. Rotary International since the inception of the global campaign has contributed USD 1.2 billion and continues with its funding effort to ensure the campaign does not suffer for want of funds. In 2007, the Gates Foundation gave The Rotary Foundation a $100 million challenge grant for polio eradication, and in 2009, increased it to $355 million. Rotary agreed to raise $200 million in matching funds by 30 June 2012, but Rotarians in fact raised $228.7 million toward the challenge. Rotary International's Annual Convention took place in Lisbon, Portugal (23-26 June) where more than 20,000 Rotarians from around the world attended the prestigious event. Polio eradication featured highly on the agenda, as in past years. John Germ, vice chair of the International PolioPlus Committee, asked Rotarians to help the funding through their efforts and "reach out to their non-Rotarian colleagues to raise money for polio eradication". Motivating Rotarians for the challenge, "Going forward, the Gates Foundation will match two-to-one, up to US$35 million per year, every dollar Rotary commits to reduce the funding shortfall for polio eradication through 2018," said Mr Jeff Raikes, CEO, BMGF, at the Rotary International's convention's held in Lisbon, Portugal. The estimated cost of the initiative's 2013-18 Polio Eradication and Endgame Strategic Plan is $5.5 billion and a funding commitment of $4 billion has been announced at the Global Vaccine Summit in April 2013. But unless the current deficit is met, the anti polio campaign is not full-proof. The campaign can be affected to an extent as the immunization efforts need to be sustained in all parts of the world. The joint effort, called End Polio Now - Make History Today, "If fully realized, the value of this new partnership with Rotary is more than $500 million (approx. 3000 crores). In this way, your contributions to polio will work twice as hard", added Raikes. Analyzing the critical phase at which 'Polio end game is at present, Mr. Deepak Kapur, chairman, Rotary's India National Polio Plus Committee (INPPC), who has been leading the effort for Rotary in India for the last more than a decade said, "GPEI's 6 year end polio strategy is a global immunization plan with the goal of ending polio while improving efforts to protect all children, including the most vulnerable, with life-saving vaccines". India has gone over two successful years without a case of Polio and the surveillance and monitoring report indicate another strong year for India to finally clinch the regional Polio-free Certification in 2014. However, the danger of virus importation exists because of the neighbouring polio endemic countries looms large. The eradication effort in Pakistan has been sabotaged by radical groups who have targeted Polio workers killing some despite which the campaign is struggling back to track in the country. Recent setbacks in the African countries and the conflict in Pakistan and Afghanistan, there are a lot of questions arising on whether the world can actually be Polio free by 2018 as set by GPEI. "Since the 6 year plan addresses all possible issues related to Polio outbreak, the strategy should not be affected due to financial crunches. If allowed Polio can rebound and consequently, within a decade more than 2,00,000 children worldwide could be paralyzed every year challenging countries like India where a child is born every second and needs protection", Chairman Kapur added. Globally, Polio has decreased by 99 percent to just 69 cases this year (as of 19 June), and only three countries - Afghanistan, Pakistan, Nigeria - remain endemic for the disease. Rotary along with all the GPEI partners are determined not to let polio make a comeback. Rotary, the initial donor to the GPEI has pledged its commitment through 2018 to raise funds and mobilize support of the endgame strategy. The extensive polio eradication infrastructure established by the GPEI is also helping to fight measles, malaria, and other diseases, along with aiding response to disaster-related health emergencies. After polio is eradicated, the endgame plan calls for the transfer of the GPEI's assets to ensure lasting public health benefits. ]]> <![CDATA[Cholesterol beats swine flu, avian flu and corona viruses: Viroblock launches new face mask ]]> https://biospectrumindia.com/news/95/3113/cholesterol-beats-swine-flu-avian-flu-and-corona-viruses-viroblock-launches-new-face-mask-.html https://biospectrumindia.com/news/95/3113/cholesterol-beats-swine-flu-avian-flu-and-corona-viruses-viroblock-launches-new-face-mask-.html Wed, 26 Jun 2013 17:38:00 +0530 Viroblock SA, a Swiss start-up, recently presented new data at ICPIC 2013 in Geneva, showing that their face-mask containing proprietary novel cholesterol depletion technology traps and kills over 99.9995% of H1N1 flu viruses (swine flu), 99.999% of H5N1 flu viruses (avian flu) and 99.997% human corona viruses on pass through air. Aimed at helping protect people from these respiratory pathogens, the mask is up to one hundred times more effective than a similar mask without Viroblock technology. The company will now start direct sales in Switzerland and is looking for distributors in other countries. "Aerobiology tests for face-masks simulate real life situations, in which the user is exposed to viruses coming in. The mask helps prevent transmission from and to the person wearing the mask." commented Dr Thierry Pelet, CSO at Viroblock. "The stringent testing demonstrates the efficacy and speed at which the cholesterol depletion technology works". Aerobiology tests, carried out in high security laboratories, create a mist of viruses on the outside of the mask, a pump is used to draw air and viruses through the mask, and finally testing for live virus occurs on the inside of the mask. "We believe that our protective face-mask can help protect healthcare, agriculture and security workers effectively, with added advantages of comfort of wear and easy identification," said Dr Jamie Paterson, CEO of Viroblock. Viroblock SA is a CTI Certified Swiss start-up located in Geneva, Switzerland. Founded in 2006 and supported mainly by Swiss investors, the company is focused on developing a unique anti-viral technology based on cholesterol depletion. ]]> <![CDATA[Indo-US biofuel project review meeting held ]]> https://biospectrumindia.com/news/95/1022/indo-us-biofuel-project-review-meeting-held-.html https://biospectrumindia.com/news/95/1022/indo-us-biofuel-project-review-meeting-held-.html Wed, 26 Jun 2013 12:17:00 +0530 The Indo-US Sustainable Advanced Ligno-cellulosic Biofuel Project's half-yearly review and planning meeting was held at Udhagamandalam, Tamil Nadu on June 12-13, hosted by Tamil Nadu Agricultural University (TNAU). Inaugurating the meeting, the university's vice-chancellor, Prof K Ramasamy spoke on the demand-supply gap for transport grade ethanol in the country and the project's role in bridging the gap. Project Investigator Dr Ahmed Kamal (Indian Institute of Chemical Technology) gave a brief account of the progress made over the last 8 months since its launch in 2012. The meeting was attended by 35 researchers from 11 consortium partners. Representing ICRISAT, senior scientist, Dr P Srinivasa Rao gave a detailed progress report of feedstock development and supply and addressed the issue of bringing marginal lands under biofuel feedstock cultivation and its implications for the livelihoods of marginal farmers in terms of food and fodder security in the states of Madhya Pradesh and Gujarat. Drs Ganesh Kumar and Beena Patel spoke on the progress made in conversion technologies and sustainability and markets. Partners from the Directorate of Sorghum Research, Rajmate Vijayaraje Scindia Krishi Vishwa Vidyalaya, Junagadh Agricultural University, TNAU, IICT, Abellon Clean Energy, Hindustan Petroleum Corporation Ltd, Indian Institute of Technology - Chennai and Delhi shared their progress. Commending the progress made, Dr Rajiv Sharma, executive director, Indo-US Science & Technology Forum underlined that threadbare discussions would help in developing a clear roadmap for success. Also, the problems faced by partners were discussed and possible solutions were suggested by the consortium. Work plans for the next six months were finalized. ]]> <![CDATA[ICAR to hold Agri-Tech investors meet ]]> https://biospectrumindia.com/news/95/6847/icar-to-hold-agri-tech-investors-meet-.html https://biospectrumindia.com/news/95/6847/icar-to-hold-agri-tech-investors-meet-.html Tue, 25 Jun 2013 15:48:00 +0530 The meet will be held at the National Agriculture Science Centre (NASC) complex, New Delhi during July 18-19, 2013.The meet is being organized to showcase and promote the agro-technologies developed by the NAIP sub-projects (2006-13) to the agri-business sector. About 50 Letters of Intent (LoIs) were signed to commercialize thirty one technologies for Rs three crore during the B2B meeting at Hyderabad in April, 2013. During the July meet, NAIP will be promoting sixty potential technologies evaluated by industry and experts. The event will see LoIs getting finalized as MoUs and new deals being signed up. Therewill be sector-wise technology presentations and B2B meetings. Agripreneurs and agribusiness industry personnel have been invited to attend the meet. ]]> <![CDATA[Venus Remedies among the best companies to work for]]> https://biospectrumindia.com/news/95/3317/venus-remedies-among-the-best-companies-to-work-for.html https://biospectrumindia.com/news/95/3317/venus-remedies-among-the-best-companies-to-work-for.html Tue, 25 Jun 2013 13:51:00 +0530 Venus Remedies is the only company from North India to have made it to the list of Top 100 in the "India's Best Companies to Work for" study conducted by the Great Place to Work Institute, India in association with The Economic Times. The company is placed at the 72nd position. Terming the achievement as a matter of great pride, Pawan Chaudhary, CMD, Venus Remedies, said, "We have been getting recognitions in the past from across the globe for our research products. This time, our HR practices have been acknowledged as people-oriented. Now a circle has been completed. We give our employees a conducive environment to learn and work so that they can in turn give great solutions. Employees are our biggest asset and all policies are oriented towards them." About 550 organisations registered for this year's study. The survey, considered to be the most comprehensive and representative study of workplace culture in corporate India, was based on the responses of 98,998 employees in these organisations, which included not only Indian and multinational companies but also public sector and not-for-profit organisations. Hailing the achievement, Dheeraj Aggarwal, chief financial officer and vice-president, HR, Venus Remedies, said, "We did remarkably well on various parameters considered for the survey. We always try our level best to make all our employees feel wanted from the moment they join us. The work timings are employee-friendly. Sitting late at work is not encouraged. Employees are motivated to strike a balance between their personal and professional lives. At Venus, we play light and soothing music to create a relaxing atmosphere for employees. The company has a team of more than 40 in-house faculty members to run the tutor and training programme for employees. This is apart from the technical and non-technical training provided through external agencies. We also seek detailed feedback from employees from time to time on their level of satisfaction." Elaborating on the company's employee welfare schemes, Aggarwal said, "We have a unique practice of a Venus Army, which handles all grievances that are reported to it. Venus Army is available round-the-clock to meet any exigencies and welfare of the employees under a meticulously designed programme called "Manav Utahan Yojana". All employees contribute Rs 50 per month towards the Venus Army Fund, which is used to support employees from economically weaker sections." Under its shagun policy, the company extends financial assistance for the marriage of employees and their immediate family members. As many as 127 employees availed the facility last year. Apart from extending car and housing loans to employees at subsidised rates, the company grants its shares to certain set of employees at nearly 95% discount. Only six companies among the top 50 are new entrants this time, down from 14 in the 2012 survey. On the other hand, there are 25 new entrants in the top 100. The parameters for the survey include genuine caring for employees, willingness to share wealth and equal opportunity for recognition, candid communication, reliability of managers, collaboration with employees, impartiality and opportunities for career growth. In simple terms, these factors connote the three fundamental relationships that an employee has-relationship with the management, with the work that the employee does and with other co-workers. The framework of the US-based Great Place to Work Institute is followed by more than 6,500 organisations globally that participate in the annual research on workplace culture across more than 45 countries. ]]> <![CDATA[Greenpeace rally expected to spice up BRAI debate ]]> https://biospectrumindia.com/news/95/3318/greenpeace-rally-expected-to-spice-up-brai-debate-.html https://biospectrumindia.com/news/95/3318/greenpeace-rally-expected-to-spice-up-brai-debate-.html Tue, 25 Jun 2013 12:37:00 +0530 Opposing the BRAI bill, Green peace has alleged that it provides for a single window easy approval mechanism to controversial GM crops. The organization known to be a fierce critic of GM crops along with GM free coalition, has organized a maha rally at Jantar Mantar, New Delhi, today on June 25, 2013. What makes it different this time is the involvement of persons from political parties. Mr Balbir Punj of Bhartiya Janta Party (BJP), Arvind Kejriwal from Aam Aadmi Party (AAP), Nikhil Dey from Mazdoor Kishan Shakti Sangthan, Rakesh Tikait and Yudhvir Singh of Bhartiya Kisan Union too are expected to join the rally along with many others. Mr Devinder Sharma, Food and Trade Policy analyst, too will join the rally, urging the government to withdraw the controversial Biotechnology Regulatory Authority of India Bill. The rally will witness the presence of eminent personalities from different parts of India. As per Greenpeace statement, "The BRAI Bill, 2013 in its current form can be clearly seen as a mechanism to give multi-national biotech giants like Monsanto a free hand to control our food and farming. It is a dangerous recipe for corruption in the country that will lower the bar of approval of risky GM crops. The BRAI Bill needs to be withdrawn. We need a biosafety protection regime which was also recommended by the parliamentary standing committee on agriculture." This protest is expected to spice up the entire debate and increase pressure on the government which has sent it the parliamentary panel for a review. Meanwhile in parallel to that, the Supreme Court too will hear the ongoing case on GM crops in the first week of July. The same is also a testing ground for the fate of the field trials and regulations of such crops, as the judgement can be a landmark one. The senior officials of the government however contest the claims of those opposing the BRAI bill. They say that the transgenic crops is only one segment that the bill seeks to regulate. Even the industry feels that the proposed regulator was important to help the biosciences area that includes key to treatment of various ailments through stem cell therapies, artificial organ transplant and animal organ transplant. Many also argue that the current regulatory mechanism is ill equipped to handle complex biology. ]]> <![CDATA[Govt to now focus on vaccine derived poliovirus ]]> https://biospectrumindia.com/news/95/8430/govt-to-now-focus-on-vaccine-derived-poliovirus-.html https://biospectrumindia.com/news/95/8430/govt-to-now-focus-on-vaccine-derived-poliovirus-.html Tue, 25 Jun 2013 11:24:00 +0530 An eleven month old immune-deficient boy in Dharur block of Beed district was found to be afflicted from Vaccine Derived Polio Virus (VDPV). He had been suffering from brain lesions and was admitted to a Government Medical college hospital on May, 7 after a month-long illness. The boy succumbed on June, 22. The main cause of his illness or death has been reported as infection in the brain. VDPVs are extremely rare and are detected in children with immunodeficiency or in populations with low levels of immunization. VDPVs are different from wild polioviruses and India has not reported any case of polio due to a wild poliovirus since January, 2011. A total of 741 children had gotten paralyzed due to the wild poliovirus in 2009 in India accounting for over half of the global polio cases against this backdrop, India's success in keeping children free from any wild polio virus for the last more than two years is being globally acclaimed as a major public health achievement. WHO removed India from the list of polio endemic countries in 2012 following one year without any case due to wild poliovirus in the country. Having completed more than two years without the wild poliovirus, India has moved closer to a polio-free certification in early 2014. "The government of India and the states have been focusing on intensifying routine immunization to minimize the risk of VDPVs. The response is consistent with the global strategy. The most important strategy for prevention of emergence of VDPVs is achieving and maintaining high routine immunization coverage with OPV doses among infants", said Mr Keshav Desiraju, secretary, department of health and family welfare, government of India. To achieve higher routine immunisation rates and protect children against all vaccine preventable diseases, the government declared 2012-13 as 'Year of Intensification of Routine Immunisation'. In 2013, the government is holding four 'Special Immunisation Weeks' in the 411,129 high risk areas identified by the polio eradication programme. These areas comprise of slums, nomadic sites, construction sites, brick kilns and other areas housing people on the move, who often miss out on immunisation due to their transient nature. These special immunization weeks in April, June, July and August are aimed at protecting the vulnerable populations with all vaccines available under routine immunisation, including tOPV. Of the 411,129 high risk areas, 82,965 are in Maharashtra. WHO Representative Dr Nata Menabde said, "India's polio surveillance programme is geared to detect VDPVs as part of AFP surveillance system supported by World Health Organization." Detection of VDPVs will not impact the polio eradication certification process. The pre-requisites for polio free certification of a region includes absence of wild poliovirus in all countries of the region for three consecutive years, presence of certification standard surveillance and the completion of laboratory containment activities. Though India has not reported any case of polio for over two years, an importation of wild poliovirus remains the larger threat to the children in India, especially in view of close proximity to polio endemic Pakistan and Afghanistan, Dr Menabde said. To ensure eradication of wild poliovirus andminimise the risk of emergence and circulation of VDPVs, the government of India is working in coordination with the Global Polio Eradication Initiative on the polio end game strategy. A group of experts headed by the Indian Council of Medical Research (ICMR) has been formed to work on this strategy. ]]> <![CDATA[ICMR seeks interest for course on computational tools in medical sciences ]]> https://biospectrumindia.com/news/95/3312/icmr-seeks-interest-for-course-on-computational-tools-in-medical-sciences-.html https://biospectrumindia.com/news/95/3312/icmr-seeks-interest-for-course-on-computational-tools-in-medical-sciences-.html Mon, 24 Jun 2013 12:19:00 +0530 The division of Epidemiology and Biostatistics (central computation), Institute of Cytology and Preventive Oncology (ICPO), is organizing a course on the importance of computational biology in medical field from August, 6 to 8, 2013 at its campus in New Delhi. The institute that is part of Department of Health Research (DHR), Indian Council for Medical Research (ICMR), aims to expose the medical researchers and professionals to statistical softwares. The contents of the course titled as 'application of statistical softwares in medical research' includes data collection tools, types of data, type of studies, introduction to commonly used statistical software, database creation, data manipulation/ transformation and importing external databases, descriptive statistics: calculating mean, standard deviation, reporting frequencies, graphical representation of medical data. IT also focuses on testing hypothesis including parametric tests: (independent t test, paired t test, ANOVA) and non-parametric tests: (Mann Whitney U test, Wilcoxon signed ranked test), correlation and overview of regression models -Linear, Multiple, binary and multinomial logistic regressions, epidemiological tests (Sensitivity, Specificity, ROC, incidence, prevalence, ratio, proportions, rates etc.), agreement analysis, Also provided will be the sample size determination and hands on training on all topics in various Statistical Softwares (SPSS, Epi-info,etc.) The enrollment may be made by paying the course fee that has been kept as low as Rs 2000. before 30th July, 2013. The number of participants for the course is limited to 30 and enrollment is purely on first come first served basis. ]]> <![CDATA[Scientists discuss the role of biotech in horticulture ]]> https://biospectrumindia.com/news/95/5358/scientists-discuss-the-role-of-biotech-in-horticulture-.html https://biospectrumindia.com/news/95/5358/scientists-discuss-the-role-of-biotech-in-horticulture-.html Mon, 24 Jun 2013 11:24:00 +0530 The Indian Institute of Horticultural Research (IIHR) organized a national seminar on horticultural biotechnology (NSHB) 2013- with the objective to take stock of current research in biotechnology and draw a roadmap for future thrusts in horticulture crops in the country. Dr N K Krishna Kumar, Deputy Director General (Horticulture), Indian Council for Agricultural Research (ICAR), New Delhi spearheaded the deliberations categorized under seven theme areas, viz., molecular markers, transgenic technology, allele mining and gene cloning, molecular diagnostics, and regeneration systems. On this occasion Dr Kumar also addressed the media and briefed about the ongoing activities and progress of biotechnological work being carried out in India. Leading biotechnologists of the country also flagged important issues that merited immediate attention as well as long-term strategic planning. More than 150 participants working on biotechnological aspects in horticultural crops participated in the seminar. ]]> <![CDATA[Tuberculosis a huge concern globally says Azad]]> https://biospectrumindia.com/news/95/3311/tuberculosis-a-huge-concern-globally-says-azad.html https://biospectrumindia.com/news/95/3311/tuberculosis-a-huge-concern-globally-says-azad.html Fri, 21 Jun 2013 17:26:00 +0530 In his inaugural address at the LRS Institute of Tubderculosis and Respiratory Diseases, the health minister, Ghulam Nabi Azad said despite socio-economic development and advances in medical science, Tuberculosis still remains a major public health concern globally. "Millions of people suffer and die from this disease every year. TB problem was very acute a decade ago in our country. However, since the Millennium Development Declaration by United Nations in 2000, the Revised National Tuberculosis Control Programme has been successful in achieving the desired goals, both for detection and cure in our country," said Mr Azad. On the occasion, Azad also released "Research Abstracts (1990-2012) - From research to clinical practice, the way ahead. Speaking further, health minister said, "Since 2007, RNTCP has achieved the case detection rate of more than 70% in line with the global targets for TB control while maintaining the treatment success rate of more than 85%. The treatment success rates have tripled from 25% in pre-RNTCP era to 87% at present. TB death rates have been reduced from 29% to 4% during the same period. Another challenge of great concern is the development of resistance to anti TB Drugs due to irregular & incomplete treatment with irrational regimens. This is being dealt with appropriate expansion of diagnostic and treatment services for managing Drug Resistant TB; i.e. MDR and XDR TB, across the country. It is a matter of great satisfaction that with the advent of effective drugs, modern technology and programme management techniques under the "Revised National Tuberculosis Control Programme", recent decline of the disease prevalence and mortality is evident." Talking about the LRS Institute of Tuberculosis and Respiratory Diseases, Azad said Lala Ram Sarup Khanna donated 5 acres of land in 1952. The Government added another 20 acres and gave this land to TB Association of India for TB hospital. With a view to give renewed priority to TB, Government of India upgraded this hospital into an Institute in 1991 and handed over to the Ministry of Health & Family Welfare. Since then the Institute has been playing a significant role as an apex Institute in the country for prevention, control and treatment of Tuberculosis and respiratory diseases." He congratulated the director, staff and the concerned officers in the health ministry for timely and successful completion of the project. "The Union Government is firmly committed to accomplish the ambitious plans for the 12th Five Year Plan Period and the vision of a "TB-free India", he added. ]]> <![CDATA[Advinus Therapeutics enters into collaboration for cancer research]]> https://biospectrumindia.com/news/95/3314/advinus-therapeutics-enters-into-collaboration-for-cancer-research.html https://biospectrumindia.com/news/95/3314/advinus-therapeutics-enters-into-collaboration-for-cancer-research.html Fri, 21 Jun 2013 13:51:00 +0530 Advinus Therapeutics and Moffitt Cancer Center announced a strategic partnership to advance the latter's discoveries to the clinics. Moffit Cancer Center has two promising targeted cancer therapies (Rb:Raf-1 disruptor and ROCK inhibitor) developed by Moffitt scientists are selected as the first set. The synergistic relationship is aimed at accelerating the translation of novel treatments for cancer from lab to clinic. Another potential dimension of the collaboration includes performing early stage clinical trials at Moffitt with various oncology drugs provided by Advinus. Moffit Cancer Center has stated that the Rb:Raf-1 disruptor holds great clinical potential because disruption of the Rb:Raf-1 interaction leads to inhibition of cellular signaling pathways involved in cell growth, blood vessel creation, and the spread of cancer cells. Similarly, the ROCK (Rho-associated protein kinase) inhibitor may have significant patient value because expression of its target ROCK1 is significantly higher in breast tumor tissue than normal tissue and is associated with aggressive disease, the spread of cancer cells and poorer prognosis. Advinus has launched a Special Purpose Vehicle incorporated as a separate legal entity, Advinus Canada, with the aim of using its pre and early clinical expertise to advance discovery programs primarily from academia. The aim behind doing so is to establish a globally networked model for innovation for efficient progression of the programs to the clinic and eventually the patient and to create a new benchmark for ROI. Advinus has selected the Rb-Raf and ROCK programs from Moffitt's Chemical Biology and Molecular Medicine program as a part of the first set of programs to progress in 2013. "The new era of pharmaceutical research and development is going to witness innovative models for globally networked partnerships that will extract the best each partner has to offer," said Dr. Rashmi Barbhaiya, chief executive officer and managing director of Advinus. "The Moffitt-Advinus collaboration is established along these lines with an aim to identify novel drug candidates to meet clinical needs and generate a benchmark for return on investment for pharmaceutical research and development." "We are delighted to embark on this exciting partnership with Advinus to leverage their skills and expertise to advance Moffitt therapies towards commercialization for improved patient care. This partnership is ripe for future growth and expansion to include other therapeutic technologies made by our internationally renowned scientists," said Jarett Rieger, director of Moffitt's office of Technology Management and Commercialization. Located in Tampa,USA, Moffitt is one of only 41 National Cancer Institute-designated Comprehensive Cancer Centers. With more than 4,200 employees, Moffitt has an economic impact on the state of nearly $2 billion. ]]> <![CDATA[India to get world class institute for agri- biotechnology soon]]> https://biospectrumindia.com/news/95/3306/india-to-get-world-class-institute-for-agri-biotechnology-soon.html https://biospectrumindia.com/news/95/3306/india-to-get-world-class-institute-for-agri-biotechnology-soon.html Fri, 21 Jun 2013 12:51:00 +0530 The deliberations that were held at National Agricultural Science Complex, New Delhi, were presided by Dr S Ayyappan, secretary, Department of Agriculture Research (DARE) and director general, Indian Council for Agricultural Research (ICAR). In his opening remarks, Dr Ayyappan outlined the events that led to ICAR's decision to establish Indian Institute of Agricultural Biotechnology. He also informed that the IIAB has been envisioned to be a Deemed University to offer quality education and undertake cutting edge research in the field of Agricultural Biotechnology encompassing various sectors. Dr S K Datta, deputy director general (crop science), ICAR underlined the importance of genetically modified (GM) crops in increasing crop productivity. He also suggested that research programmes of complementary nature could be taken up initially such as phenotyping stress-tolerant genotypes.Dr. R. Ramani, director, IINRG and OSD of the Institute made presentation and briefed the gathering about the immediate plans of the institute. Dr K.M.L. Pathak, deputy director general (DDG), (Animal Science); Dr B. Meenakumari, DDG (Fisheries); Dr Arvind Kumar, DDG (Education) and Dr N.K. Krishna Kumar, DDG (Horticulture) also participated in the consultation.Thirty participants from different organizations and universities took part in the meet. The day-long deliberations encompassed all aspects of the Institute, including academic and organizational structure, activities, research priorities, infrastructure and management. In his concluding remarks, Dr. Ayyappan thanked all the experts for their useful suggestions and participation in the meet. He assured that all efforts would be made to ensure recruitment of quality manpower as well as creation of good infrastructure. ]]> <![CDATA[Ranbaxy gets another blow, EU slaps huge fine ]]> https://biospectrumindia.com/news/95/3315/ranbaxy-gets-another-blow-eu-slaps-huge-fine-.html https://biospectrumindia.com/news/95/3315/ranbaxy-gets-another-blow-eu-slaps-huge-fine-.html Thu, 20 Jun 2013 14:37:00 +0530 The nine drugmakers that include India's Ranbaxy and Danish company Lundbeck have been fined a total of 146 million euros (Rs 1, 150 crore) by EU antitrust regulators for blocking the supply of a cheaper anti-depressant medicine to the market. Ranbaxy was fined with 10.3 million euros (close to Rs 80 crore) by the authority. The companies are now planning to appeal against the EU decision. The other penalised companies were Arrow, Resolution Chemicals, Xellia Pharmaceuticals, Alpharma - which is now part of Zoetis Products LLC, AL Industrier. The punishments follow a 2009 report by the European Commission on the pharmaceutical sector, which said "pay-for-delay" deals lead to consumers paying as much as 20 percent more for their medicines. The EU action came two days after the US supreme court said that US regulators could challenge deals between brand-name drug companies and generic rivals because of the higher consumer costs. Pay-for-delay agreements involve brand-name firms paying generic companies not to deliver versions of their drugs, which usually cost a fraction of the original medicine, to market, although the issue is also complicated by patent ownership. In this case, Lundbeck was accused of paying other companies to have them delay delivering a generic version of its anti-depressant medicine citalopram to the market. "Agreements of this type directly harm patients and national health systems, which are already under tight budgetary constraints," said EU Competition Commissioner, Joaquin Almunia. "The Commission will not tolerate such anticompetitive practices." The European Commission, which acts as competition regulator across the 27-member, European Union handed Lundbeck the largest fine totalling 93.8 million euros. As a result, Lundbeck cut its guidance for operating profits this year. The Commission fined Germany's Merck KgaA 21.4 million euros and handed a further 7.77 million euro fine jointly to Merck and its former subsidiary Generics UK, which is now owned by U.S. generic drugmaker Mylan. The other penalised companies were Arrow, Resolution Chemicals, Xellia Pharmaceuticals, Alpharma - which is now part of Zoetis Products LLC, AL Industrier ]]> <![CDATA[Quintiles Named a â€œBest Place to Work in ITâ€? by Computerworld for Fifth Time]]> https://biospectrumindia.com/news/95/3323/quintiles-named-a-best-place-to-work-in-it-by-computerworld-for-fifth-time.html https://biospectrumindia.com/news/95/3323/quintiles-named-a-best-place-to-work-in-it-by-computerworld-for-fifth-time.html Thu, 20 Jun 2013 13:36:00 +0530 Quintiles has recently been again named to IDG's Computerworld "100 Best Places to Work in IT" list for the fifth time. Computerworld has recognized the top 100 companies for information technology professionals based on criteria such as diversity, career development, training and retention. "We are extremely honored that the Quintiles organization has been recognized by Computerworld once again," said Quintiles Chief Information Officer Richard Thomas. "Quintiles works with leading biopharma and healthcare companies around the world, supporting them in their mission to improve health. We have been working over the years to create an environment where top technology talent has the opportunity to develop professionally and make a difference in the lives of patients around the world." In late 2012, Thomas was named a Computerworld "Premier IT Leader," further indication of Quintiles' position as the biopharma services industry's information technology leader. Quintiles was ranked sixth in the 2012 InformationWeek 500, an annual list of the top technology innovators in the United States, evidence that great workplaces can translate to innovative products and services. It addresses the requirements of biopharmaceutical and other healthcare companies including payers and providers. Born from the ember of statistical insight in a small university preview, Quintiles has grown extensively and strategically. "We applaud the organizations on the Best Places to Work in IT list for creating and sustaining dynamic IT work environments," said Scot Finnie, editor in chief of Computerworld. "It's clear that the best IT workplaces are constantly raising the bar with great benefits, new learning opportunities, access to cutting-edge technologies and challenging business-critical projects." Moreover, it uses the expertise and insights to help customers optimize the value of their drug development. ]]> <![CDATA[ ABLE-AG welcomes GEAC's move to allow field trials of GM crops ]]> https://biospectrumindia.com/news/95/3301/-able-ag-welcomes-geacs-move-to-allow-field-trials-of-gm-crops-.html https://biospectrumindia.com/news/95/3301/-able-ag-welcomes-geacs-move-to-allow-field-trials-of-gm-crops-.html Wed, 19 Jun 2013 17:07:00 +0530 ABLE-AG, the agriculture biotechnology industry body says that it is encouraged by the green signal received from the GEAC administered by Ministry of Environment and Forests (MoEF) for conducting research field trials of agriculture biotechnologies; these will offer farmers access to in-the-seed choices for insect protection, salt tolerance, weed management, water use efficiency, and nitrogen use efficiency in castor, rice, maize, cotton, and wheat. The applicants can now go ahead with planting once the states also give the required No-Objection certificates. Dr N. Seetharama, executive director, ABLE -AG told BioSpectrum, "The industry has suffered losses both in terms of investments and enthusiasm. There has been enough negativity on the GM crops. It can be a good start as it takes ten to twelve years to develop the final product. There are so many processes involved including the regulatory approvals from the state governments as well. Therefore, the clearances are most welcome." The 117th meeting of GEAC, which was held in March, 2013 after the committee was reconstituted in February 2013, published its decisions to permit research field trials of castor by the Directorate of Oilseeds Research (an ICAR institution); in rice which offers insect protection, and salt tolerance from Bayer, BASF, Mahyco; in maize which offers insect protection, and/or weed management from Monsanto; in cotton which offers weed management, and/or water use efficiency, and/or nitrogen use efficiency from Bayer, Mahyco, and Central Institute of Cotton Research (CICR); and in wheat which offers weed management by Mahyco. The industry has been urging the MoEF to expedite clearance of research field trials to ensure timely sowing during this Kharif (wet season). ABLE-AG had written to Minister of Environment Smt. Jayanthi Natarajan, and GEAC Chairman and Additional Secretary of MoEF Shri Hem Pande urging them to personally consider timely research did not cost our nation an entire season, informed Dr Seetharama. "We welcome and thank the minister for this decision. This research is in India for India. In addition, our member company researchers are seriously engaged to offer Indian farmers more innovative technologies and choices to optimize their yields, income, and convenience, while reducing their risks when farming. We hope the GEAC administered by MOEF will meet soonest to consider the remaining 53 pending applications for research field trials planned by the Indian private and public sector researchers," said Dr Seetharama. With the early onset of monsoon, researchers are finding it a challenge to plant these trails during this kharif in in some northern states due to delayed publishing of the minutes of GEAC. However, they are hopeful of planting some research field trials in the Southern States, and continuing research smoothly hereon. ]]> <![CDATA[Finally GEAC nod to few key GM crop field trials ]]> https://biospectrumindia.com/news/95/3246/finally-geac-nod-to-few-key-gm-crop-field-trials-.html https://biospectrumindia.com/news/95/3246/finally-geac-nod-to-few-key-gm-crop-field-trials-.html Wed, 19 Jun 2013 15:50:00 +0530 In a major relief to the agri-biotech industry that has been running pillar to post for putting its case before the government and regulators, the Genetic Engineering Appraisal Committee (GEAC) has cleared field trials of GM)rice, wheat, maize and castor for the upcoming Kharif season. However at the same time, the clearances for another 53 field trials are still pending with the regulatory body. The clearance includes extension of permits, due to expire in states opposed to the field trials or wanting a relocation of their sites, Bayer Bioscience has got open-ended clearance to test GM rice in all four regions of the country. The open-ended clearance allows the tests but only in consenting states: that is, no company can conduct these trials without the approval of state governments. In light of this ruling, biotech companies are expected to move their trial sites to 'willing' states. Mayhco and BASF India Limited too have got the GEAC nod for trials of GM rice. The Hyderabad-based Directorate of Oilseeds Research's GM castor too has been re-approved for field trails reviving a permit that had lapsed owing to lack of approval from the Andhra Pradesh government.Monsanto India Limited has been allowed to test its GM maize at alternate sites after it ran into opposition in many of the states, which had been earlier cleared by the Union government for its trials. Mayhco has on the other hand been given an extended clearance for its trials of GM wheat after the company had failed to get the green light from the state government. Besides these food crops, the GEAC has also given the nod for further field testing of various GM cotton varieties by Bayer, BASF and Mayhco. These clearances have come ahead of the Supreme Court judgment on a petition challenging the existing regulatory mechanism for GM crops in the country. The next hearing of the case is supposed to on July 1, 2013 where all the concerned stakeholders including the Association of Biotechnology led Enterprises (ABLE)- Agriculture Group (AG), activists, government and others are expected to make strong arguments for their point of views. At the same time, the Biotechnology Regulatory Authority of India (BRAI) bill is pending with parliamentary standing committee and it doesn't seem to be an easy affair to pass it in near future. ]]> <![CDATA[Roselabs launches PFS facility ]]> https://biospectrumindia.com/news/95/5878/roselabs-launches-pfs-facility-.html https://biospectrumindia.com/news/95/5878/roselabs-launches-pfs-facility-.html Wed, 19 Jun 2013 14:55:00 +0530 The Roselabs Group, has recently launch it's first of kind complete end-to-end pre-filled syringes (PFS) making facility available to the world. The Roselabs Bioscience Limited and Roselabs Polymers company has set up this and has already invested more than Rs 400 crore in this exclusive new state-of-the-art facility near Ahmedabad. It has recently got approval from the WHO-GMP and has also initiated the procedure of getting other countries' regulatory approvals. It is expecting to get approvals from 35-40 countries across South East Asia, Africa and Latin America in the coming months for its new project. The unique selling proposition of Roselabs is that it offers a composite PFS solution under one roof. The existing and potential market for pre-filled syringes in India and globally is huge. Nearly 95% of PFS are imported into India which is one of the fastest growing markets for this sector." said Mr. Zameer Agarwal, Director of Roselabs Bioscience Ltd.It new ventures have already invested for more than Rs 400 crore for PFS facility at Ahmedabad, in the state of Gujarat which has a capacity to manufacture 8 lakh syringes a day. The practice of pre-filled syringes provides multiple advantages that are vital for any patient anywhere in the world. A PFS remains sterilized for much longer than standard syringes and are not likely of discrepancy in the drug strength. Most healthcare professionals now prefer PFS to conventional syringes, as they are pre-measured and prepared to use with secure sterility guarantees, and offer convenience and well being to healthcare professionals as well as patients. In terms of vials and ampoules, there is over-filling of 15-25%, while in case of PFS it is only 2-3%, which in itself is a major saving. PFS usage also ensures that medical waste (of which syringes, vials and ampoules are a major part) is brought down by nearly 50%. It is anticipated that every year there are around 3 million mishaps taking place due to needle stick injuries, and PFS cuts down this risk. ]]> <![CDATA[Pawar calls for strengthening international research institutions ]]> https://biospectrumindia.com/news/95/5593/pawar-calls-for-strengthening-international-research-institutions-.html https://biospectrumindia.com/news/95/5593/pawar-calls-for-strengthening-international-research-institutions-.html Wed, 19 Jun 2013 12:40:00 +0530 Recently while speaking at the Food and Agriculture Organization (FAO), United Nations, the union agriculture minister, Sharad Pawar mentioned that the agriculture is a critical sector of Indian economy, providing employment to nearly 60% of our population. "Nearly sixty percent of our cropped area is rainfed with no assured source of irrigation which inhibits the realization of full yield potential. It is challenging to meet the demands of our growing population for food, feed, fibre and fuel with limited natural resources, mainly land and water, and more frequent climatic variability," he had mentioned. Pawar further said, "We have embarked on a path breaking journey to intensify support to our farmers, 85% of whom have operational holdings below 2 hectares. We have initiated a slew of policy and programmatic measures to increase investment in Agriculture, create opportunities for private sector through marketing reforms and launched a focus on food security in a mission mode approach for increasing production of food." Agriculture minister said that while efforts are being made to bridge the yield gaps to increase agricultural production, it is a matter of concern that there is stagnation in realizing the higher yield potential in different crops. He explained, "New technological tools especially through genetic engineering need to be employed more aggressively to build tolerance to various abiotic and biotic stresses that inhibit crop yields. Research products made available as a result should be easily accessible and affordable to all. In this regard, we call for strengthening the CGIAR institutions for generating significant technological innovations that could then be easily adapted and up scaled by the National Agriculture Research Systems." Pawar talked about India's commitment to the strengthening of newly launched Agriculture Market Information System hosted in FAO under the G20 Action Plan on Agriculture. He said, "We are now regularly publishing periodical reports in the form of Agricultural Outlook of select commodities where situation analysis and forecasts are presented in the short and the medium terms. We are grateful to FAO for supporting this initiative with technical assistance on international exposure and capacity building. We believe that informed decisions based on sound analysis help develop better understanding of food situation internationally and locally." ]]> <![CDATA[BNH HCG opens women's cancer center in Mumbai]]> https://biospectrumindia.com/news/95/7736/bnh-hcg-opens-womens-cancer-center-in-mumbai.html https://biospectrumindia.com/news/95/7736/bnh-hcg-opens-womens-cancer-center-in-mumbai.html Tue, 18 Jun 2013 18:45:25 +0530 With 110.4 per 1,00,000 women in Mumbai being diagnosed with cancer (according to Population Based Cancer Registry) BNH HCG Cancer Center, a unit of HCG recently announced that it would be setting up a one of its kind women's cancer centre in Maharashtra. The cancer center is equipped to not only diagnose, but also provide advance treatment for all kinds of cancers in women such as breast cancer, cervical cancer, gall bladder cancer, oesophagus cancer, amongst others. There is a full time team of specialists to diagnose, treat as well as counsel women who have cancer. The number of cases are expected to rise manifold in the next 20 years and early diagnosis of cancer leads to better medical outcomes and improves quality of life. The center is equipped with Digital Mammogram and Automated Breast volume, an innovative ultrasound imaging system designed to provide three-dimensional views of the breast tissue for use in breast cancer screenings. The automatically acquired images provide physicians with data about the entire breast, including coronal view- a feature which was not available with conventional ultra sound systems. This helps radiologist differentiate cysts and calcifications from cancerous tumours. Dr. Bhavana Parikh, Consultant, Medical Oncologist, BNH HCG Cancer Center, said, "The incidence of breast cancer among the urban women is on the rise and women in their early 40's are diagnosed with breast cancer, which is alarming. 90% of the breast cancers can be cured with optimal therapy if diagnosed early and patients can have good quality of life." Dr. Sanjay Dudhat, Consultant, Surgical Oncologist, BNH Cancer Center, said, "With advancements in cancer treatment we are able to preserve the organs, since quality of life is as important as survival. For a patient diagnosed with breast cancer, losing the breast affects her psychologically, physically and mentally. It's very important to use organ preservation protocols, to improve quality of life and social well being. At BNH HCG Cancer Center, we do breast conservation surgery on almost all the patients diagnosed with breast cancer and cosmetic outcome of surgery is excellent." ]]> <![CDATA[Dr.Lalji Singh to head comittee on regulation of stem cell therapies]]> https://biospectrumindia.com/news/95/3224/dr-lalji-singh-to-head-comittee-on-regulation-of-stem-cell-therapies.html https://biospectrumindia.com/news/95/3224/dr-lalji-singh-to-head-comittee-on-regulation-of-stem-cell-therapies.html Tue, 18 Jun 2013 18:30:22 +0530 Recently the ministry of health and family welfare, government of India nominated Dr Lalji Singh,vice chancellor of the Banaras Hindu University (BHU),as the chairman of high power committee for the regulation of stem cell and other cell based therapies being practiced in India. The committee will have four experts, with the chief scientist of Centre for Cellular and Molecular Biology (CCMB), Hyderabad Dr Gopal Pande as a member of the committee and the rest two members will be appointed by Dr Singh. In the meantime, the high power committee will review the current scenario of the stem cell therapy in the country and make particular recommendations on the effective regulation of stem cell products and stem cell therapy or research by Central Drug Standard Control Organisation (CDSCO). The committee is accountable to indicate the area, which do not come under the domain of CDSCO but need the direction of other bodies if any. The committee will also propose the pre-requisite to be followed for the approval of proposed indications for the stem cell products or therapies with the required differentiation of 'who will control the claims mentioned under therapy which may fall out of domain of CDSCO. Furthermore, this committee will suggest a road map to establish collaboration and training programme with international agencies. And hence it will suggest the future scope of stem cell therapy and other bodies in the country. ]]> <![CDATA[Venus Remedies gets Mexico patent for Potentox]]> https://biospectrumindia.com/news/95/7405/venus-remedies-gets-mexico-patent-for-potentox.html https://biospectrumindia.com/news/95/7405/venus-remedies-gets-mexico-patent-for-potentox.html Tue, 18 Jun 2013 12:41:00 +0530 The patent provides Venus Remedies, an exclusivity period for its novel antibiotic product, Potentox up to 2025. Granted by the Mexican Institute of Industrial Property (IMPI), the patent protects the composition of Potentox. The drug is also protected by a number of other patents from various other countries, including USA, India, Australia, New Zealand, South Korea, South Africa, Canada and Ukraine. Potentox is an antibiotic adjuvant entity (AAE), a drug effective in case of hospital-acquired pneumonia and febrile neutropenia infections, primarily caused by quinolones or aminoglycoside-resistant microbes. Venus is upbeat about the response Potentox has received in the domestic and global markets. "The product is growing at a compound annual growth rate (CAGR) of 50 per cent since the past three years. To take this novel antibiotic adjuvant entity to Mexico, the company is already holding talks with some big pharmaceutical companies there for strategic tie-ups. The common technical document (CTD) for Mexico is ready, and we will soon be filing it. But it will take us another two-three years to launch the product in this market," said Dheeraj Aggarwal, chief financial officer, Venus Remedies. In Mexican intensive care units (ICUs), the overall cost of one single healthcare-associated infection episode is US $12,155. As per WHO statistics for Mexico, healthcare-associated infections are the third most common cause of death. Mexico spends about 70% of its health budget on extra costs incurred due to hospital-acquired infections. Clinical trials conducted for Potentox on more than 500 patients have indicated a drop in cost of therapy by 20-30% as compared to conventional therapies. Besides, studies conducted in hospitals across India have shown that Potentox is suitable for the treatment of infections caused by various resistant gram-negative pathogens in the ICU. Terming such global recognitions for novel research products as a matter of pride for the research team at Venus, Dr Manu Chaudhary, joint managing director and director-research, Venus Medical Research Centre (VMRC), Venus Remedies, said, "It will motivate us to keep working hard to bring to the world our greatest research breakthroughs that would help in bridging the gaps in the field of emerging antimicrobial resistance." The global hospital-acquired bacterial infections market was estimated to be worth US $9 billion in 2010. Potentox is designed to address the needs of almost 50 per cent of this market. The hospital-treated infections (HTI) market is projected to grow at a rate of 2.7 per cent annually in major economies. ]]> <![CDATA[India faces TB drug shortage]]> https://biospectrumindia.com/news/95/3320/india-faces-tb-drug-shortage.html https://biospectrumindia.com/news/95/3320/india-faces-tb-drug-shortage.html Mon, 17 Jun 2013 17:00:00 +0530 According to international aid organisation MÃ©decins Sans FrontiÃ¨res(MSF), India is currently experiencing stock outs across the country of both paediatric TB drugs and those used to treat drug-resistant TB (DR-TB). The stock out is said to be related to the persistent issues with drug procurement that India faces in many of its public health programmes. The resultant deadly delay in tendering for these drugs and the resulting drug stock outs are said to be one of the reasons why India has one of the world's highest burdens of DR-TB. MSF has appealed to the Indian government to urgently address this issue and the almost routine delays of procuring drugs to treat tuberculosis "As a country with such a high burden of tuberculosis, MSF is deeply disturbed that India is experiencing stock outs of critically needed drugs to treat children and those with drug-resistant TB", said Leena Menghaney, India manager of MSF's Access Campaign. "In this instance, it's a stock out that can cost people's lives and the government must act urgently to fix the problems. Under India's public TB treatment program, the central government is responsible for buying drugs and distributing them to the states which then provide treatment. Dr. Homa Mansoor, the TB Medical Referent for MSF India has said, "As a TB treatment provider, MSF is witnessing the impact this is having on our own patients. In our Mon, Nagaland project, I've seen a 12 year-old girl on treatment arrive with her father after a long journey to get her medicine. The medicines were out of stock, but luckily we had six days' worth of drugs available from a patient who had died. Otherwise, we're having to resort to breaking adult pills to give to children, which is really dangerous as it could over- or under-dose them." Dr Mansoor added,"A continuous, sustainable supply of quality-assured medicines is vital for TB patients to have even half a chance of being cured. Its just not good enough that India talks of scaling up DR-TB treatment, but finds the medicine cabinet empty at a time when the most vulnerable patients - those diagnosed with DR-TB - are most desperate to get the medicines that can treat them". The stock outs in India are occurring as the World Health Organization late last week issued interim guidelines on bedaquiline, the first new drug to treat TB in 50 years, approved by the US Food and Drug Administration at the end of 2012. ]]> <![CDATA[ASSOCHAM to organize BIO-AGRI 2013]]> https://biospectrumindia.com/news/95/7654/assocham-to-organize-bio-agri-2013.html https://biospectrumindia.com/news/95/7654/assocham-to-organize-bio-agri-2013.html Mon, 17 Jun 2013 16:20:00 +0530 Among the oldest apex chambers of the country, ASSOCHAM has been involved in promotion of innovative practices and technological interventions in agriculture over a period of time now.. The industry body in order to pursue the goal of agricultural development, is organizing BIO-AGRI 2013 at New Delhi on July 03, 2013. Themed as "Towards Productive Efficiencies and Farmers Growth", the summit will see the deliberations happening on the R&D, technical innovations, investments, policy guidance, market outlook, prospects for international cooperation in research & development, The ASSOCHAM has decided to host this summit in the backdrop of the 12th five year plan that stressed on need for a greater technical thrust and the strategy for agriculture. The notification from ASSOCHAM quotes the statement from planning commission that mentioned, "In order to provide scientific focus to some of the critical areas, research consortia platforms are to be launched in seed, diagnostics and vaccines, nanotechnology, bio-fortification, agri-incubators, water, natural fibers, health foods, hybrids, secondary agriculture, farm mechanization, precision farming and energy, genomics, molecular breeding and agro-biodiversity." The main objectives include the creation of platform to discuss challenges and enabling solutions for promoting biotechnology, keep the business world in general and delegates in particular abreast about emerging opportunities for investment in BioAgri sector in India, and sharing bio-tecnologies and services towards increasing agricultural efficiency to meet challenges. The summit is also expected to witness deliberation on PPP or other new business models for thwarting investments in Bio-agriculture. As per the industry body, "Agriculture continues to be backbone of developing economies including India for its vital role in providing food, feed, fibre, fuel and livelihood for the world's 800 million people who suffer from hunger and poverty. Of the many strategies that have been forwarded to address the issues related to productive efficiencies and farmer's growth, biotechnology with its potential and promises is one answer for providing food and nutritional security to the ever-expanding population." ]]> <![CDATA[US Supreme Court rules against gene patenting]]> https://biospectrumindia.com/news/95/6619/us-supreme-court-rules-against-gene-patenting.html https://biospectrumindia.com/news/95/6619/us-supreme-court-rules-against-gene-patenting.html Fri, 14 Jun 2013 17:43:34 +0530 In a case that has gathered worldwide attention for its implications on the global biotech industry, the US Supreme Court has ruled against the patenting of human genes. The case involves Myriad Genetics, a US based company that hold patents for two genes, namely BRCA1 and BRCA2, the overexpression of which indicate a woman's chances of developing breast or ovarian cancer. These were recently in the news when Hollowood actress Angelina Jolie had used a test based on these genes to understand if she was in the cohort of at risk breast cancer patients. At the same time, the Supreme Court has ruled that cDNA or complementary DNA that is the DNA synthesized complemetarily from an mRNA strand. In response to the judgement, Jim Greenwood, president and CEO of the Biotechnology Industry Organization (BIO), issued a following statement which said,"The Supreme Court today summarily ruled that so-called cDNA remains eligible for patenting. cDNA is the commercially most important form of DNA used in biotechnology. Today's decision offers urgently-needed certainty for research-driven companies that rely on cDNA patents for investment in innovation." He however approached the judgement on patenting genes with caution by saying, "In other respects, however, the Supreme Court's decision today represents a troubling departure from decades of judicial and Patent and Trademark Office precedent supporting the patentability of DNA molecules that mimic naturally-occurring sequences. In addition, the Court's decision could unnecessarily create business uncertainty for a broader range of biotechnology inventions.The United States is now the only developed country to take such a restrictive view of patent eligibility, signaling an unjustified indifference towards our global economic and scientific leadership in the life sciences." The first controversy regarding patenting in genetics had erupted in 1971, when Dr.Ananda Chakrabarty, then a employee at GE, had rengineered to strains of bacteria that could be used in clearing oils spills. He was initially denied a patent for the genetically modified organism, but later granted one on the basis of the fact that the organism was sufficiently modified by using specifi techniques. Dr.Ananda Chakrabarty is currently a senior science mentor at Ahmedabad based Amrita Therapeutics. In addition to the views of BIO, Mr.Greenwood added that paents have never conferred ownership over genes. He said," While Myriad Genetics is not a member of BIO, we do represent companies that research, develop and use modern biotechnology to produce products ranging from life-saving medicines and vaccines to renewable fuels, industrial enzymes and disease-or pest-resistant crops. Such companies have long relied on patents on preparations of DNA molecules and other biological chemicals in order to bring innovative, socially beneficial products to the marketplace." ]]> <![CDATA['OSDD can prove effective to generate generic medicines' ]]> https://biospectrumindia.com/news/95/5088/osdd-can-prove-effective-to-generate-generic-medicines-.html https://biospectrumindia.com/news/95/5088/osdd-can-prove-effective-to-generate-generic-medicines-.html Fri, 14 Jun 2013 17:30:00 +0530 Speaking recently at the golden jubilee celebration of government pharmacy college, Bangalore, Dr A P J Abdul Kalam spoke about Open Source Drug Discovery (OSDD), introduced by Council of Scientific and Industrial Research (CSIR), which focuses on collaborative effort to achieve breakthroughs in the world of medicines and bringing down their cost of medicines. He said the OSDD aims to find cure for diseases like tuberculosis and malaria. He said the 'open source' phenomenon has given rich result in the field of software and may give similar result in the area of medical research. Enumerating the benefits of such an approach, he said the medicines thus discovered would be free from monopoly. He said only generic drugs would be produced and they would be affordable for the common man. "If the concept of 'open source' (universal access and contribution to a budding idea/technology via free licence) can be applied to developing software, then why not to promoting research and development into finding cure of diseases like malaria?", asked Dr Kalam who is also known as missile man of India. ]]> <![CDATA[Technologies must reach end users : Tariq Anwar]]> https://biospectrumindia.com/news/95/8391/technologies-must-reach-end-users-tariq-anwar.html https://biospectrumindia.com/news/95/8391/technologies-must-reach-end-users-tariq-anwar.html Fri, 14 Jun 2013 13:01:00 +0530 During his recent visit to the National Institute of Animal Nutrition and Physiology (NIANP), Bangalore, the minister of State for Agriculture and Food Processing Industries, Mr Tariq Anwar addressed the scientists and staff of the NIANP. The minister emphasized that the technologies developed should reach the end users. He called upon the scientists to bring out more number of feasible technologies to meet the expectations of farming community and industries. He went around the various facilities and showed keen interest in different activities of the institute. He appreciated the state of the art facilities and infrastructure created as well as the quality of work being done at the institute. Dr C S Prasad, Director, NIANP welcomed the minister and briefed about the activities and the technologies developed by the institute. ]]> <![CDATA[Apollo Pharmacy resumes sale of Ranbaxy drugs ]]> https://biospectrumindia.com/news/95/6341/apollo-pharmacy-resumes-sale-of-ranbaxy-drugs-.html https://biospectrumindia.com/news/95/6341/apollo-pharmacy-resumes-sale-of-ranbaxy-drugs-.html Fri, 14 Jun 2013 11:44:00 +0530 As per the statement issued on June 13, 2013 by the Apollo Pharmacy, "We have been working with Ranbaxy over the past week to validate the necessary documentation in line with quality standards followed by International quality certifying authorities. Ranbaxy has provided us Batch quality certification for all their products certified by the government approved certifying laboratories. The reports completely satisfy the quality norms stipulated by WHO-GMP, department of pharmaceuticals, government of India as well as Drug and Cosmetic Act." Apollo Pharmacy is a division of healthcare major Apollo Hospitals Enterprise Ltd (AHEL). The chain is present across the country, both as standalone standard format stores and those attached to AHEL hospitals and clinics. Despite having asked its stores to temporarily suspend the sale of Ranaxy drugs earlier, the hospital, however, had not issued any separate advisory to its doctors. The statement issued to media mentioned further, "We have also understood the stance of the DGHS of India in this regard and received confirmation from them that there are no quality issues in the Ranbaxy Products currently marketed in India. We are glad that this issue has been resolved. We will continue to stock and dispense Ranbaxy products across all our pharmacies and continue to provide the best patient care without missing a beat." ]]> <![CDATA[Sun Pharma to pay $550 million to settle patent infringement case]]> https://biospectrumindia.com/news/95/7171/sun-pharma-to-pay-550-million-to-settle-patent-infringement-case.html https://biospectrumindia.com/news/95/7171/sun-pharma-to-pay-550-million-to-settle-patent-infringement-case.html Thu, 13 Jun 2013 18:50:31 +0530 Sun Pharmaceutical Industries announced that it together with its subsidiaries, have settled an ongoing litigation regarding Sun Pharma subsidiary's generic pantoprazole. Under the terms of the litigation settlement between Sun Pharma, and Wyeth, (now a division of Pfizer) and Altana Pharma AG, (now known as Takeda GmbH), Sun Pharma will pay a lump-sum US $550 million as a part of this settlement. In 2005, Wyeth and Altana had filed a patent infringement suit against Sun Pharma after Sun Pharma filed its abbreviated new drug application for pantoprazole. Sun Pharma launched its generic pantoprazole in the US on January 30, 2008. In April 2010, a jury had determined that Altana's patent is not invalid. On June 3, 2013, the Court began a jury trial to assess the amount of past damages that Sun Pharma owed for infringing Altana's now expired patent. This settlement now culminates the ongoing litigation. Sun Pharma can continue to sell its generic pantoprazole in the U.S. ]]> <![CDATA[Wockhardt Foundation wins 2013 Rajiv Gandhi Excellence Award]]> https://biospectrumindia.com/news/95/8447/wockhardt-foundation-wins-2013-rajiv-gandhi-excellence-award.html https://biospectrumindia.com/news/95/8447/wockhardt-foundation-wins-2013-rajiv-gandhi-excellence-award.html Thu, 13 Jun 2013 18:32:55 +0530 Wockhardt Foundation was recently honored with the Rajiv Gandhi Excellence Award 2013 on June 11th at New Delhi, by the hands of union minister of coal Shri Sriprakash Jaiswal. Wockhardt Foundation is a national, secular, not-for-profit organisation engaged in social service and human welfare activities. Its ambitious social growth programme of providing free, primary healthcare to the rural and remote parts of India through its "Mobile 1000" initiative have been successful. It's 16 programs have made appreciable change in arenas of operations to the many lives of the underprivileged. Having recognized the problem of the rural populations, it launched "Mobile 1000" which today has a pan-India presence operating in 12 states of India. "Wockhardt Foundation operates its social programmes based on the 3 B's - Big, Best, and Bold. The Big ensures scale, the Best ensures quality, and the Bold ensures need" said Dr.Huzaifa Khorakiwala, trustee and CEO, Wockhardt Foundation. Other than "Mobile 1000", its different programmes like Bio-Toilet, SHUDHU water purification tablets,POSHAK malnutrition supplement,Khel Khel Mein,HIV/AIDS have also started productive and significant outcome. It also provides specially prepared nutrition supplement for HIV positive children to strengthen their immunity. Wockhardt Foundation has nation-wide group of more than 350 rapidly-growing, powerful, and sensitive Individuals who provide full-time service to the foundation that reiterates the motto of "where every smile counts" into reality. It's other programs like Mobile 1000 eye, Mobile 1000 urban, Mobile Health Vans rural, HIV/AIDS (WHARF), SHUDHU water purification tablets, Little Hearts and Dr-Health have created importance results. ]]> <![CDATA[NPPP to change dynamics of Indian pharma]]> https://biospectrumindia.com/views/95/4072/nppp-to-change-dynamics-of-indian-pharma.html https://biospectrumindia.com/views/95/4072/nppp-to-change-dynamics-of-indian-pharma.html Thu, 13 Jun 2013 17:26:00 +0530 The Indian pharmaceutical industry has witnessed healthy growth in the last decade, driven by factors like rising consumption levels in the country and strong demand from export markets. The domestic pharma market which has recorded a CAGR of around 14-15 percent in the last 10 years is now the third largest in the world in terms of volume and 14th largest in terms of value. However, despite this high growth, drug consumption per capita in India is still among the lowest globally. The per capita consumption volumes are estimated to be 8-12 times lower than in the US and Japan. Hence, the tremendous growth potential for the industry cannot be understated. But having said so, the industry is expected to face some major transformational challenges in the coming decade. While patent expirations, lack of new product pipelines, coupled with general economic downturn are just some of the challenges confronting the global pharma industry, the Indian pharma sector on the other hand, is braving odds of weak macro factors of the economy, increasing competition and pricing pressures in certain categories. In the past two years, the growth of the domestic pharma market has slowed down a bit to 12-13 percent due to weak macro factors and increasing competition from unlisted players and MNC pharma companies. Over the last couple of years, we have seen more and more big pharma firms entering the branded generic space to compete with domestic drug makers. This trend is expected to intensify in the coming years adding more pressure in this already fragmented market. You could also see increased mergers and acquisition activities, with MNC Pharma companies acquiring the India related businesses of firms. The high growth rates of 15-20 percent enjoyed by the industry just a couple of years back are most likely to be a thing of the past. Under such a scenario, the Indian industry has to settle for a muted growth of around 10-12 percent in the immediate future. But pricing pressures will not only come from increasing competition, but also from regulatory bodies. The new National Pharmaceutical Pricing Policy (NPPP), which is proposed to be implemented in the near future, could change the structure and dynamics of the Indian pharmaceutical industry. It is likely to impact the profitability of firms and would make new product introductions a challenging proposition. The Indian market, it should be noted, is already amongst the lowest priced in the world. Another emerging trend, which will get more pronounced in the coming years, is that chronic therapies, such as diabetes, cardiovasculars, and products used to treat central nervous system ailments, are growing faster than acute therapy. Currently, the Indian pharmaceutical market is more than 60 percent acute with the rest being chronic. The changing dynamics of the Indian pharma, calls for more collaboration rather than competition. Within a short span of eight years, Glenmark's seven out-licensing deals till date with big pharma companies is a case in point. In the coming years, we will see more such collaborations with big pharma which will help Indian companies share risks and generate constant revenue. Indian pharma companies also need to increasingly focus on their overseas businesses to drive growth. Patent expiry opportunities, coupled with efforts to contain healthcare spends, are likely to drive the generic market in developed markets like the US and Europe. On the other hand, affordability and availability will make a case for generics usage in the branded generic developing markets like Russia and Brazil. For example, in case of Glenmark over 70 percent of our revenues comes from overseas or non-India operations. In the coming years, innovation will be key to success (and survival itself). The definition of innovation should expand beyond 'reverse-engineering' to more challenging areas like new drug discovery and development. India is all set to enter the top 10 pharma markets of the world by 2015 (from its current position of 14th in terms of scale) and will continue to remain a priority market for all operating players. Competition will intensify in this market. The CRAMS opportunity will increase but making it profitable will depend on the way organizations are able to innovate the business model. I am sure that just like in the past, the time has come for India to evolve and create a unique model that will benefit both patients and companies in our quest for providing quality and affordable medication for the entire world. ]]> <![CDATA[Bill Gates finds ICRISAT research 'cool']]> https://biospectrumindia.com/news/95/6104/bill-gates-finds-icrisat-research-cool.html https://biospectrumindia.com/news/95/6104/bill-gates-finds-icrisat-research-cool.html Wed, 12 Jun 2013 18:43:16 +0530 With food insecurity and malnutrition persisting as the greatest challenges facing humanity in the coming decades, Mr Bill Gates, on a recent visit to the organization's Hyderabad headquarters acknowledged the potential of ICRISAT's works on grain legumes and dryland cereals in helping millions of smallholders farmers in the drylands of Asia and sub-Saharan Africa lift themselves out of hunger, malnutrition and poverty. Mr Bill Gates, Co-chair of the Bill & Melinda Gates Foundation, visited the International Crops Research Institute for the Semi-Arid Tropics (ICRISAT) headquarters in Patancheru, Hyderabad on Thursday, 30 May. This was Mr Gates' first visit to this Institute where he held discussions with the management and several key scientists to gain a better appreciation of the foundation's research for development investments to ICRISAT. "ICRISAT crops are great , as they target millions of smallholder farmers globally," said Mr Gates. The tour highlighted the uniqueness and importance of the works and initiatives of ICRISAT and its partners, particularly in providing modern crop improvement technologies and best management practices on once 'orphan' or neglected crops like grain legumes and dryland cereals. "That was cool!" was how Mr Gates reacted on ICRISAT's lysimeter facility for phenotyping, a first of its kind in the world and the largest within the CGIAR system. The facility is now being successfully used for measuring plant responses to water stress related to drought and climate change adaptation "The drylands are home to 644 million poorest of the poor, and highly nutritious, drought-tolerant crops such as grain legumes and dryland cereals are the best bets for smallholder farmers in these marginal environments to survive and improve their livelihoods," explains Dr William Dar, ICRISAT Director General. ICRISAT scientists demonstrated the different high-end sciences that the institute uses - genomics, bioinformatics, phenotyping and genetic engineering - all integrated or complementing each other as part of its crop improvement program for smallholder farming. Considered as international public goods, scientists and national partners worldwide can have free access to ICRISAT's genotyping and phenotyping data, captured and analyzed through its work on bioinformatics, for their respective molecular breeding processes. Mr Gates also engaged in a roundtable discussion with ICRISAT scientists on the impacts and challenges of applying the science on the ground. Two projects funded by the foundation were highlighted as the case: the HOPE project (Harnessing Opportunities for Productivity Enhancement of Sorghum and Millets) in sub-Saharan Africa and South Asia which seeks to increase by 30% the productivity of sorghum and millets in 200,000 farmers' fields; and the Tropical Legumes I & II project which aims to enhance productivity of six legume crops (groundnut, cowpea, common bean, chickpea, pigeonpea and soybean) by at least 20% through improved cultivars and management practices and the development of markets and value chains. The poor in the target areas of these two projects are the most malnourished, food-insecure in the world, unable to earn adequate incomes from agriculture which is their only source of food, nutrition and livelihoods. The impacts and achievements of these foundation-funded projects are now changing the lives of the poor, providing millions of smallholder farmers with tools and opportunities to boost their yields, increase their incomes, and build better lives for themselves and their families. ICRISAT is a member of the CGIAR Consortium. CGIAR is a global agriculture research partnership for a food secure future. ICRISAT is headquartered in Patancheru near Hyderabad, Andhra Pradesh, India, with two regional hubs and five country offices in sub-Saharan Africa. It is a member of the CGIAR Consortium. ]]> <![CDATA[Greenpeace puts up unique protest against GM crops]]> https://biospectrumindia.com/news/95/6533/greenpeace-puts-up-unique-protest-against-gm-crops.html https://biospectrumindia.com/news/95/6533/greenpeace-puts-up-unique-protest-against-gm-crops.html Tue, 11 Jun 2013 16:55:00 +0530 For the first time, crops circles have been created in India. Recently, similar crop circles were formed in Ahmedabad and Bangalore by Greenpeace volunteers who came from various corners of the country to generate public awareness against the 'imminent invasion of GM crops in India.' "Safe food is my right and GM crops are the biggest threat to it" said Pranay Jasodia, Actuarial Science student of Utpal Sanghvi college in Mumbai, who has joined hands with 20 others to make these intricate crop circles. The design which was 150X180 Feet in size featured a slash over 'GE', as a mark of protest against the government's decision to introduce the controversial Biotechnology Regulatory Authority of India (BRAI) bill, which provides for a single window easy approval mechanism to controversial GM crops. According to Neha Saigal, sustainable agriculture campaigner at the Greenpeace, India, GM crops were being pushed in India to benefit multinational biotech giants like Monsanto. "Through the Biotechnology Regulatory Authority of India (BRAI) Bill, which can also be called India's Monsanto Promotion and Protection Bill, the Government is paving a way for the biotech corporations like Monsanto to take control of our food and farming by providing a single window approval mechanism to GM crops." said Neha. "While Monsanto's influence within the US Government is more than apparent, the same is now being ensured by the Indian government here through the BRAI Bill," added Neha. ]]> <![CDATA[Biological E set to buy French Valneva's CMO unit]]> https://biospectrumindia.com/news/95/3953/biological-e-set-to-buy-french-valnevas-cmo-unit.html https://biospectrumindia.com/news/95/3953/biological-e-set-to-buy-french-valnevas-cmo-unit.html Tue, 11 Jun 2013 15:06:00 +0530 The sale of its clinical manufacturing operations (CMO) in Nantes to Biological E which is dedicated to the manufacturing of clinical trial materials, is part of Valneva´s strategy to realize cost synergies of around $6.6 million (EUR 5 to 6 million) annually following the merger of Intercell and Vivalis to create Valneva. The divestment of the CMO facility is expected to contribute up to $3.9 million (EUR 3 million) cost savings to the annual merger-synergies. In addition, Valneva will receive an undisclosed purchase price, exceeding the current book value of the facility. Valneva and Biological E established a first partnership in 2005 for the development and commercialization of a novel Japanese Encephalitis (JE) vaccine for endemic regions, based on Valneva´s JEV technology. The vaccine, which was successfully developed under this partnership, is being commercialized in India under the trade-name Jeev and further territory expansions in the JE-endemic markets are planned. The CMO facility in Nantes will not be related to the JEV vaccine program. Valneva and Biological E are also in discussions to potentially extend their strategic partnership into new vaccine development programs based on Valneva´s EB66 manufacturing platform. The EB66 cell line is an advanced system for the production of a wide variety of human and veterinary viral and therapeutic vaccines. Valneva remains the owner of the EB66 cell line and will continue to license it for human and veterinary product development to pharmaceutical and biotech companies and to propose EB66 process development services. Mr Thomas Lingelbach, president and CEO, and Mr Franck Grimaud, president and chief business officer, Valneva, mentioned, "This agreement demonstrates that Valneva's merger strategy to become a leading sustainable biotech company in antibodies and vaccines, is on track. We are pleased to broaden our excellent strategic partnership with Biological E with this transaction and believe that it will create additional opportunities for our two companies going forward." ]]> <![CDATA[KIRAN launches Agricultural Messaging Service from ICAR-Barapani ]]> https://biospectrumindia.com/news/95/5712/kiran-launches-agricultural-messaging-service-from-icar-barapani-.html https://biospectrumindia.com/news/95/5712/kiran-launches-agricultural-messaging-service-from-icar-barapani-.html Tue, 11 Jun 2013 12:24:00 +0530 Advanced Messaging System (AMS) is basically for agriculture development in North East Region. Apart from delivering agro-meteorological data and advisory on a regular basis for crop management and allied agricultural practices under climate risk, it will establish linkage between market and farmers using modern information. Launched at Barapani centre of the Indian Council for Agricultural Research (ICAR) on June 09, 2013, the system is comparable with that of Survey of India where the satellite map is further enriched by the ground party; the next attempt will be to launch a system similar to 'Mother Child Tracking System' in which a willing farmer would be served with a personalized advice based on his/her or her crop/livestock/fishery etc. So far, the messaging service has been initiated among 400 farmers from districts of Meghalaya on a pilot scale. It is envisaged to include a total of 2475 farmers all over the north-east by the end of July. The messaging service would be contextual and would deliver season specific agro-husbandry practices, relevant to farmers in NEH region. Advisories regarding practices, problems and interventions would also be given on every alternate day to the tribal farmers through an SMS portal designed under the KIRAN platform. ]]> <![CDATA['It was always our dream to discover a new entity' ]]> https://biospectrumindia.com/news/95/5307/it-was-always-our-dream-to-discover-a-new-entity-.html https://biospectrumindia.com/news/95/5307/it-was-always-our-dream-to-discover-a-new-entity-.html Mon, 10 Jun 2013 17:53:00 +0530 Last week, the Zydus Group announced a breakthrough in its research efforts with Lipaglyn (Saroglitazar), a novel drug for the treatment diabetic dyslipidemia or hypertriglyceridemia in Type II diabetes. India has a population of nearly 65 million diabetics and 77 million pre-diabetics. 85 - 97% of the diabetes patients suffer from dyslipidemia or lipid abnormalities.The drug has been approved for launch in India by the Drug Controller General of India (DCGI, with Zydus introducing the drug into the market in the next few months. Also, Lipaglyn is the first Glitazar to be approved anywhere in the world. The journey towards India's first indigenously developed NCE started in 2000, at Zydus Research Centre, with the molecule being identified in 2001. The IND for the molecule was subsequently submitted in 2004. The clinical trials for the same took place in 50 centers across India including KEM and Hinduja hospital, Mumbai, St Johns Hospital, Bangalore, PGIMER, Chandigarh. Zydus spent approximately $250 million for the development of this drug. It has plans to spend a further $150 million for getting global approvals. About the journey Mr. Pankaj R. Patel, chairman and managing director, Zydus Cadila says," It was always our dream to discover new entities. We had an option of outlicensing it a few years ago, but our team was decided against it. We hope that this will set a positive trend for research in India and I would like to dedicate this to all the Indian research scientists in the field of drug discover" About Lipaglyn, he added, "Lipaglyn provides patients suffering from diabetic dyslipidemia the option of a once-daily oral therapy that has a beneficial effect on both lipid parameters as well as glycemic control." Diabetic Dyslipidemia is a condition where a person is diabetic and has elevated levels of the total cholesterol, the "bad" low-density lipoprotein (LDL) cholesterol and the triglycerides and a decrease in the "good" high-density lipoprotein (HDL) cholesterol concentration in the blood. Lipaglyn is a non-thiazolidinedione and is the first therapy to be approved for this condition. Hence, addressing the problem of diabetes and dyslipidemia is crucial in tackling the health risk posed by CVD. Lipaglyn has a predominant affinity to PPAR alpha isoform and moderate affinity to PPAR gamma isoform of PPAR nuclear receptor subfamily. The molecule has shown beneficial effects on lipids and glycemic control without side effects. Mr.Patel added that they envision Lipaglyn to become one of the Top 50 products in the Indian pharma business with revenues exceeding Rs 100crore in the next three to five years. Additionally, Cadila currently has 8 INDs in different stages of development and is working towards an aim to achieve sales of $300 billion by 2015 and become a research based pharma company by 2020. Zydus also announced that it would offer a dedicated Lipaglyn support programme to patients and caregivers. The programme shall provide important support and information regarding access, adherence, education and thereby help patients to start and appropriately manage their disease and therapy over time. ]]> <![CDATA[Interest sought to learn latest technique in stem cells]]> https://biospectrumindia.com/news/95/1297/interest-sought-to-learn-latest-technique-in-stem-cells.html https://biospectrumindia.com/news/95/1297/interest-sought-to-learn-latest-technique-in-stem-cells.html Mon, 10 Jun 2013 13:59:00 +0530 The symposium on pluripotent stem cells is designed to introduce very small embryonic-like stem cells (VSELs) and ovarian stem cells and their role in reproductive health. VSELs are yet poorly studied stem cells in testis (being more primitive to spermatogonial stem cells) and in ovary along with the ovarian stem cells are responsible for oogenesis in adult life. They are implicated during menopause, PCOS, POF and other pathologies including cancers. They can also be targeted to restore fertility in cancer survivors. The symposium to be held in September 2013, will be organized by the National Institute for Research in Reproductive Health (NIRRH), Indian Council for Medical Research (ICMKR), and Indian Society for the Study of Reproduction and Fertility (ISSRF) at New Delhi. Primordial germ cells which migrate into the gonadal ridges during early development persist into adulthood as VSELs, not only in the gonads but also various adult body tissues. They maintain lifelong homeostasis and have far-reaching implications in reproductive health. Recent discovery of VSELs in various adult body organs including gonads have sparked an interest from a regenerative medicine point of view. Also as a part of workshop, training will be given to identify and isolate these VSELs from the mammalian gonads. The symposium/ workshop will be useful to researchers working in the area of reproductive biology having interest in stem cell biology. The aim of the course is to create awareness on the concept of recently discovered VSELs in adult mammalian gonads and the implications in reproductive biology.The workshop also aims to train participants on methods to identify and isolate these VSELs from mammalian gonads. The concept of presence of stem cells in adult ovary is highly debated, but they exist and areas active as spermatogonial stem cells. A recent review of Woods and Tilly (2013) where they have compared testicular and ovarian stem cells but still do not acknowledge existence of VSELs in mammalian gonads. But VSELs exist not only in adult mammalian ovary but also in adult testis. The workshop will provide new advances in field of gonadal stem cells, concept of primordial follicle assembly in adult ovary rather than the concept of fixed number of follicles and about a common and most primitive stem cell population in adult mammalian gonads. The training course, limited to 15 participants, will provide an overview on VSELs - pluripotent stem cells existing in adult mammalian gonads. The last date for sending interest along with a write up is July 30, 2013. But VSELs exist not only in adult mammalian ovary but also in adult testis. The workshop will provide new advances in field of gonadal stem cells, concept of primordial follicle assembly in adult ovary rather than the concept of fixed number of follicles and about a common and most primitive stem cell population in adult mammalian gonads. The training course, limited to 15 participants, will provide an overview on VSELs - pluripotent stem cells existing in adult mammalian gonads. The last date for sending interest along with a write up is July 30, 2013. ]]> <![CDATA[Diabetes to affect 100 million Indians by 2030 : White paper ]]> https://biospectrumindia.com/reports-white-papers/95/6179/diabetes-to-affect-100-million-indians-by-2030-white-paper-.html https://biospectrumindia.com/reports-white-papers/95/6179/diabetes-to-affect-100-million-indians-by-2030-white-paper-.html Mon, 10 Jun 2013 12:04:00 +0530 The national white paper "Insights from Multi Stakeholder Consultation - Management & Care of Diabetes in India" was released by Dr Sayeda Hameed, member, Planning Commission at a two-day national non communicable diseases (NCD) summit was organised by the CII and pharmaceutical company, Eli Lilly held in New Delhi on June 07, 2013. The white paper, which is the first of its kind on NCDs encapsulates some of the best practices and the suggestions from a diverse range of experts. It includes input received from the five state roundtable forums with multi- stakeholder groups organized at state capitals of Rajasthan, West Bengal, Kerala, Maharashtra and Chhattisgarh. Recommendations in the white paper are intended to strengthen the existing national policies and programme around diabetes management. One of the key recommendations of the white paper is to focus on building capacity of primary healthcare workforce and also introduce innovative educational tools for training like diabetes conversation maps. Addressing the inaugural programme summit, focusing on the theme of "Strengthening Policies for Diabetes Care," Dr Hameed said that the increasing prevalence of the disease, governmental delivery systems at the states and centre alone will not be able to combat increasing threat of non communicable diseases (NCDs) in the country. "We need multi sectoral collaborative efforts to address the present and future challenges posed by NCDs in country wherein every sector needs to share personal responsibility. Plan for the health sector in the 12th five year plan cannot be an isolated one and it needs to be integrated with the plans of all sectors. Currently, more than 61 million people in India have diabetes, compared with 50.8 million last year, an increase of over 12 per cent. By 2030, more than 100 million people in India will likely develop the disease. In addition, the International Diabetes Federation estimates that 9.2 per cent of adults in India have diabetes, making its prevalence second only to China. In 2012, diabetes caused 983,000 deaths in India, the largest contributor of mortality. The summit was supported by the National Programme for Cancer, Diabetes, Cardiovascular Disease and Stroke (NPCDCS), Ministry of Health and Family Welfare and the Indian Council for Medical Research (ICMR). Dr Sayeda Hameed, Member, Planning Commission was the Chief Guest on the occasion. Addressing the programme as Guest of Honour, Mr Keshav Desiraju, secretary, Health and Family Welfare expressed the need to have an intermediate level of public healthcare workers beyond the ASHA workers. He added that there should be specific models of public private partnerships evolved with clear identification of roles and responsibilities. Addressing the programme, Dr Jagdish Prasad, DGHS, Ministry of Health and Family Welfare emphasized the need for corporate to come forward and contribute to the cause of NCDs. Mr Jannie Oosthuizen, Lilly's Vice president for Asia operations, Ms Kiran Majumdar Shaw, chairperson CII, National Committee on Biotechnology and Ms Shobana Kamineni, chairperson, CII National Committee of Public Health addressed the inaugural programme. Senior officials of ministry of health and family welfare, leading diabetes experts, scientists, business leaders, representatives from international and national development agencies, and academicians and researchers engaged in the field of diabetes management attended the inaugural programme. Senior state-level government officers from many states implementing the NPCDCS programme also attended the programme. ]]> <![CDATA[Govt for mainstreaming of AYUSH under NHRM during 2009-13 ]]> https://biospectrumindia.com/news/95/5428/govt-for-mainstreaming-of-ayush-under-nhrm-during-2009-13-.html https://biospectrumindia.com/news/95/5428/govt-for-mainstreaming-of-ayush-under-nhrm-during-2009-13-.html Mon, 10 Jun 2013 11:11:00 +0530 The union minister for health and family welfare, Ghulam Nabi Azad recently mentioned that the government efforts have resulted in the establishment of new AYUSH facilities in 803 Primary Health Centres, 113 Community Health Centres, 24 District Hospitals and up-gradation of 379 exclusive AYUSH hospitals and 415 Dispensaries in the country. Addressing the Inaugural function of Dr. Prasanta Banerji Homeopathic Research Foundation and Launch of Book on Banerji Protocols on June 08, 2013, Azad said mainstreaming of AYUSH has been one of the important strategies envisaged under the NRHM. During 2009-13, the total of Rs 553 crore has been given to the various states for mainstreaming of AYUSH under National Rural Health Mission (NHRM). Accordingly, the Department of AYUSH supported the setting up of six 50 bedded Integrated AYUSH Hospitals in Mizoram, Manipur, Tripura, Himachal Pradesh, Jammu & Kashmir and Uttarakhand and five 10 bedded Integrated AYUSH hospitals in Assam, Arunachal Pradesh, Meghalaya, Nagaland and Sikkim. Altogether 11,478 AYUSH doctors and 4,894 AYUSH para-medics have been appointed on contract basis at Primary Health Centres and Community Health Centres under NRHM across the country. It has also implemented various schemes in the eleventh plan for development of all the four core areas of education, research, drug development and healthcare delivery. Homoeopathy has also been benefitted tremendously from these schemes, especially the Schemes on Centre of Excellence, Public Health Initiative and Extra mural research. There is peaceful co-existence of Allopathy with Ayurveda and Siddha in the country now. All these medical systems are being utilized in the national healthcare delivery system, each to its potential and availability in different parts of the country. Homoeopathy is now well assimilated into the ethos of Indian heritage and is widely accepted by the public for many of their healthcare requirements. The health minister said since the launch of the National Rural Health Mission in 2005, substantial progress has been achieved in the health sector. Over 8 lakh 60 thousand Community Health Workers called ASHAs have been appointed in villages to facilitate interface between the communities and health system. Under Janani Surakhsa Yojana (JSY), complemented by Janani Shishu Suraksha Karyakram (JSSK), institutional deliveries have seen a quantum jump, leading to unprecedented increase in the institutional deliveries from 7 lakhs in 2005-06 to nearly One Crore and Ten lakhs in the past two years. To cater to the increased demand, more than 25,000 additional beds have been sanctioned across 415 health facilities in 11 States. There has been tremendous improvement in the referral transport and out-reach services through over 18,000 Mobile Medical Units and Ambulances. A name, address and telephone based Mother and Child Tracking System (MCTS) has been put in place to reach out to every pregnant woman for proper care during pregnancy and to every child for proper vaccination. Data of more than 4.3 crore women and 3.5 crore children has been captured as of 7the June, 2013. A latest initiative is the "Rashtriya Bal Swasthya Karyakram", which was launched on 6th February, 2013 from a tribal block of Thane District in Maharashtra. This national programme is for Universal Screening of Children for Disorders, Diseases, Deficiencies and Disabilities from birth up to 18 years and will cover about 27 crore children across the country, including 17 crore school going children. Speaking about Dr. Prasanta Banerji Homeopathic Research Foundation, Azad said the book on "Banerji Protocols" is the result of the efforts of Dr. Prasanta Banerji who has been in practice for over 55 years and his son, Dr. Pratip Banerji who has been working with him for 22 years now. The book is about using homeopathic medicines in a scientifically acceptable way, where diseases are diagnosed in the same way as Allopathy but the medicines are prescribed in fixed protocols for every disease. The purpose of the book is to make available, to a healthcare professional knowledge gathered by the experience of over 70 years of using Homeopathy and the Banerji Protocols cover general diseases as well as some types of cancer. The father-son duo deserves commendation for the fact that while the clinic patient footfall is 1,200 patients a day, over 700 patients are treated free of charge every day. The Foundation also sees about 150 to 200 cancer cases a day. It has also entered into research collaborations with many institutions of international repute to achieve standardised treatment protocols, which allow replicability in the treatment of patients suffering from the same disease with the same fixed protocol of medicine. ]]> <![CDATA[Global In vitro diagnostics markets outpace pharma industry growth, finds Frost & Sullivan]]> https://biospectrumindia.com/reports-white-papers/95/3264/global-in-vitro-diagnostics-markets-outpace-pharma-industry-growth-finds-frost-sullivan.html https://biospectrumindia.com/reports-white-papers/95/3264/global-in-vitro-diagnostics-markets-outpace-pharma-industry-growth-finds-frost-sullivan.html Fri, 07 Jun 2013 17:35:00 +0530 Despite global economic and industry challenges, in vitro diagnostics(IVD) markets are growing robustly at double the rate of the global pharmaceutical industry in some segments.Growth in emerging markets and next-wave emerging markets, particularly in the Asia-Pacific (APAC) region, are the most important factors in formulating future strategies. Frost & Sullivan's Analysis of the Global In Vitro Diagnostics Market research finds the market size was $45.68 billion in 2012 and forecasts revenue to reach $64.65 billion in 2017. While the U.S. and Western Europe are the largest IVD markets, APAC and Eastern Europe are projected to be the fastest growing. The research covers immunochemistry, clinical microbiology, tissue diagnostics, hemostasis, hematology, molecular diagnostics, self-monitoring blood glucose (SMBG), and point of care testing (POCT) segments. "The APAC region holds the greatest number of next wave emerging markets, such as Indonesia, Vietnam and the Philippines," noted the analyst, Frost & Sullivan. "This fast rising regional market must be part of every IVD company's long-term strategy." APAC healthcare expenditure is forecast to increase 151 percent by 2020. The demand for better quality healthcare and healthcare infrastructure development will drive strong demand for IVD in the region.The largest markets continue to be the U.S. and Western Europe, which collectively represent nearly 60 percent of the global IVD market. The anticipated outcome for these markets, however, varies. "Unfavorable business conditions for IVD are slowing the U.S. market, forcing market participants to pursue outside markets that are demonstrating rapid growth," remarked the analyst. "On the other hand, despite challenges in reimbursement and a need for ConformitÃ© EuropÃ©enne (CE) marking reform, Western European markets exhibit an upward trajectory." Such optimism will, however, be tempered by lower public health reimbursement in Western Europe and Medicare cuts in the United States. This will restrain demand across all segments of the IVD market in those regions. "Such trends will act as a further spur for competitive IVD companies who have long recognized slowing growth in developed nations and have pursued emerging markets and other strategies," said the analyst. "Global IVD market participants will employ a diverse set of strategies rather than rely on comprehensive product portfolios to expand their businesses." ]]> <![CDATA[Lucknow biotech park plans to expand its activities ]]> https://biospectrumindia.com/news/95/5496/lucknow-biotech-park-plans-to-expand-its-activities-.html https://biospectrumindia.com/news/95/5496/lucknow-biotech-park-plans-to-expand-its-activities-.html Tue, 04 Jun 2013 11:57:00 +0530 During his recent visit to Lucknow Biotech Park, Mr Jawed Usmani,chief secretary, government of Uttar Pradesh interacted with the entrepreneurs of the biotech park who requested incentives in the form of preferential purchase of their products. Assuring all support, Mr Usmani advised Dr PK Seth CEO, Biotech Park to prepare a list of requests of the park entrepreneurs and send it to the principal secretary Science technology. Subsequently, Dr P K Seth made a brief presentation on biotechnology applications in agriculture and health and how park and biotech products can contribute in enhancing the overall productivity and value addition of the produce. The biotech park CEO in the presentation stressed that Biotech Park is predominantly an incubator and a larger area of 100 to 150 acres of land is needed for setting up of an industrial biotech park. The chief secretary, accompanied with Dr Har Saran Das, principal secretary, department of science and technology, government of Uttar Pradesh along with other officials, planted Royal Palm trees in the lawns of the park and then visited the Incubator II where he visited Rama Associates who market their products in USA (brand- Veria) and interacted with R&D Scientists of the company. They visited tissue culture primary and secondary hardening facilities where more than 7.5 lakhs G9 banana were under various stages of hardening. The process of hardening right from taking out of the plants from tissue culture bottles to potting in plastic bags was demonstrated. The chief secretary appreciated the quality of plants and he subsequently visited the Biofertilizer Unit where Mr. Sanjeev Chowdhury, Director, HBL and Dr Arun Sharma, Chief Scientist, HBL who are operating the facility in joint collaboration under PPP mode, explained the products being produced and advantages of the use of biofertilizers. The two senior officials also saw the tissue culture laboratory which has capacity to produce up to 20lakh G9 banana plants in a season. The chief secretary and principal secretary visited the analytical and quality control, molecular biology and microbiology laboratories. At analytical and quality control laboratory he interacted with the finishing school students and enquired about the usefulness of the training they are undergoing. The students, who were from different cities like Chennai, Delhi, Raipur, Bhopal, Meerut, Agra, Dibrugarh informed that they are finding the finishing school very interesting and useful. They are getting hands on training earlier they were not exposed to industrial biotechnology and requirements of industry and such advanced instruments. ]]> <![CDATA[Indian government backs generic drug industry]]> https://biospectrumindia.com/news/95/3483/indian-government-backs-generic-drug-industry.html https://biospectrumindia.com/news/95/3483/indian-government-backs-generic-drug-industry.html Tue, 04 Jun 2013 10:42:00 +0530 A fortnight after Ranbaxy's $500 million settlement with the US Department of Justice after it pleaded guilty for civil and criminal charges pertaining to irregularities in in its data integrity and manufacturing processes, the Government of India has came forth with an assurance about the drugs being manufactured in India being subject to scrutiny by various agencies. It says," There have been extensive media reporting in the print as well as electronic about on the quality of drugs (pharmaceutical products like APIs and formulations) manufactured in India for exports. Some isolated reports have also been received about export of spurious / counterfeit drugs attributed to some source in India. There are reasons to believe that vested interests are raking up isolated issues reported regarding technical deficiencies on manufacturing and GMP. India is enjoying a unique position of low cost manufacturing and highest quality medicine, best of both the worlds. (The) Government has strong reason to believe that some of the spurious drugs detected in the international markets, alleged to be exported from India, are desperate attempts by other countries getting affected by the strength of Indian pharma industry." Several newspaper reports of hospitals issuing directives to stop issuing Ranbaxy medication have also led to serious doubts about the quality of medicines. The press note says that while the Pharmaceutical sector is a highly regulated one and the exports are heavily guided by various regulatory regimes of the importing countries, there is also a requirement for continuous monitoring of quality related aspects including complaints of sub-standard / falsified drugs from various countries. All the concerned organizations in the government are constantly interacting to ensure that India's image as a safe exporter is protected from all angles. Government and the industry is already working on a 'trace and track' mechanism which would enable monitoring of the supply chain possible at all the three levels viz. Tertiary, Secondary & Primary. Pharmexcil, the industry body for pharma exports states that, India had, as on 30th December 2012 over 3000 Drug master filings (DMF's) with USA amounting to a almost 40% of the total DMF's filed With USFDA. These are filed by over 233 different companies from India. During the year 2012 USFDA has granted 476 ANDAS and India has 178 market authorizations of them i.e. amounting to 37.4% of the total. As on 30th Dec 2012 over 2275 ANDA's (Abbreviated new drug application)(Generics) are approved by USFDA covering over 31 different companies. There are over 550 manufacturing sites registered with USFDA out of Which 323 sites are approved by USFDA as on 31st March 2013. 30 companies have over 902 CEP's approved by EDQM, which is more than 25% of the total CEP's approved by EDQM globally. 27% of the formulations are exported to USA and India has a share of 15% of US generics by way of volume. The government reiterated its stand of India being a low cost quality exporter of drugs by saying that "There are more than 350 manufacturing sites endorsed by EU for their GMP in India as on 30th April 2013. All the facts quoted above speak about India's ability to harness large talent pool to produce quality pharmaceuticals - second to none in quality and that too at the most competitive prices.(The figures) indicate the strong presence of Indian industry in the US and the reports of US FDA penalizing Indian companies are only a small aberration." India is currently 4th in the world in terms of production volumes while it is 13th in domestic consumption. Over 55% exports of India are to highly regulated markets.USA is the largest exports destination followed by UK. India is also the largest exporter of formulations in terms of volume with 14% market share and 12th in terms of export value of bulk actives and dosage forms. ]]> <![CDATA[Dr. Reddys and FUJIFILM call off generics deal]]> https://biospectrumindia.com/news/95/3298/dr-reddys-and-fujifilm-call-off-generics-deal.html https://biospectrumindia.com/news/95/3298/dr-reddys-and-fujifilm-call-off-generics-deal.html Mon, 03 Jun 2013 17:59:16 +0530 Dr. Reddy's Laboratories and FUJIFILM have terminated the an agreement to enter into an exclusive partnership in the generic drugs business for the Japanese market and to establish a joint venture in Japan. Based on the MoU signed on July 28, 2011, the two companies had conducted detailed studies on the establishment of a joint venture for developing and manufacturing generic drugs in Japan. However, as Fujifilm realigns its long-term growth strategy for the pharmaceutical business,ã€€both companies have led to a mutual agreement to terminate the MoU.Commenting on the development, GV Prasad, Chairman and CEO, Dr. Reddy's said, "Unfortunately, we will not be able to partner with Fujifilm specifically for generic formulations business in Japan. However, I want to reinforce our commitment towards a planned entry into Japan to bring affordable and innovative drugs to more patients worldwide." Takatoshi Ishikawa, director corporate vice president and general manager of Pharmaceutical Products Division said, "In the long-term we will be focusing more on priority fields such as new drugs in cancer field, more value-added super generic, and bio-related business by using our core technologies: analysis technologies, original nanotechnology, and high reliability and high quality manufacturing technologies. Meanwhile, we will continue future collaboration with Dr. Reddy's in other fields." The two companies will continue to explore partnership or alliance opportunities in other pharmaceutical businesses such as Active Pharmaceutical Ingredient (API) development and manufacturing, contract research and development and manufacturing, and the development and marketing of super-generics. ]]> <![CDATA[Hester Biosciences crosses Rs.65 crore in revenues]]> https://biospectrumindia.com/news/95/3297/hester-biosciences-crosses-rs-65-crore-in-revenues.html https://biospectrumindia.com/news/95/3297/hester-biosciences-crosses-rs-65-crore-in-revenues.html Mon, 03 Jun 2013 17:40:58 +0530 Hester Biosciences has reported a turnover of Rs. 651.04 million as compared to Rs. 482.64 million for the year 2011-12, thereby registering a growth of 34.89%. PBT increased by 23.14% in the corresponding period. The Board of Directors have recommend a dividend of 20%, that is Rs. 2.00 per equity share for the financial year 2012-13, subject to the approval from the shareholders. The Board has further proposed to formulate a dividend payout policy for the company which would be implemented from the financial year 2013-14. During 2012-13 Hester was awarded WHO-GMP certification. It also made its foray into animal health products with a wide range of medicines and feed additives. Additionally a bivalent Marek's Disease live vaccine for the poultry was developed which will prove to be an import replacement. Also in addition to 5 cattle vaccines, a PPR vaccine (for sheep & goat) and Brucella vaccine (for cattle) were developed which would contribute towards the disease eradication programs of the Government of India ]]> <![CDATA[Govt invites suggestions for soft loan to pharma enterprises ]]> https://biospectrumindia.com/news/95/3299/govt-invites-suggestions-for-soft-loan-to-pharma-enterprises-.html https://biospectrumindia.com/news/95/3299/govt-invites-suggestions-for-soft-loan-to-pharma-enterprises-.html Mon, 03 Jun 2013 15:33:00 +0530 The department of pharmaceuticals (DoP), ministry of chemicals and fertilizers, government of India has requested all the concerned stakeholders to submit their comments or suggestions on draft of pharmaceutical technology upgradation scheme (PTUAS). The department intends to bring a soft loan scheme to assist the pharma medium enterprises (MEs) for upgrading their manufacturing units to World Health Organization (WHO) Good manufacturing Practices (GMP) or other international standards. The notification signed by Mr R K Maggo, deputy secretary to the government of India asked the concerned persons to send their comments/suggestions on the draft scheme available at DoP website, www.pharmaceuticals.gov.in up to June 13, 2013. The suggestions by all the stakeholders, pharma associations or government bodies have been requested to email the comments to Mr S.D. Maurya, Joint Director (Cost). ]]> <![CDATA[DBT, ICMR partner to promote AIDS research ]]> https://biospectrumindia.com/news/95/5984/dbt-icmr-partner-to-promote-aids-research-.html https://biospectrumindia.com/news/95/5984/dbt-icmr-partner-to-promote-aids-research-.html Mon, 03 Jun 2013 12:20:00 +0530 The Human Immunodeficiency Syndrome (HIV) still remains one of the most challenging viral diseases. The prevention of HIV Infection or curtailing its progression remains one of the greatest scientific challenges. Development of effective biomedical tools for HIV prevention has raised several outstanding scientific questions about the mechanistic nature of protective immune responses, the host factors that influence susceptibility to and protection from disease, effects of the infection on the developing and aging human immune systems and how to enhance the existing immune response. Under the above mentioned joint DBT-ICMR collaborative programme [Clinical Research Consortium], proposals have been invited from interested researchers to study intricate relationships between HIV pathogenesis and immune defense in Long Term Non-Progressors (LTNPs) (symptomatic individuals having a CD4 T cell count >500 cells/µL for >7 years without ART); Elite elite controllers (EC) (Non-Progressors with a viral load of <50 copies/ml); HIV-Exposed Sero-negative (HESN) and High Risk Sero-negative cohorts. The interdisciplinary research in these areas would therefore lead to important knowledge-driven interventions and technologies in India that can be sustainably implemented in clinical practice and in the community. Also the research proposals may include the research progress on microbicides that include any biocidal compound or substance whose purpose is to reduce the infectivity of microbes, such as viruses or bacteria. The proposals must be inter-institutional and should include establishment of new or engagement of existing clinical site(s) supporting the cohorts mentioned above and a central storage facility of the biological samples. The proposals must also include a process for management, sharing, training, sustenance and scope plan. As per DBT, the concept notes would be scrutinized and evaluated within a fixed time period in accordance with the stated goals of the programme, uniqueness, feasibility and track record of the main investigators. The last date for submission of call for proposals is June 30, 2013. ]]> <![CDATA[Indo-German partnership in biotech ]]> https://biospectrumindia.com/news/95/3824/indo-german-partnership-in-biotech-.html https://biospectrumindia.com/news/95/3824/indo-german-partnership-in-biotech-.html Fri, 31 May 2013 14:58:00 +0530 Based on the Program of Cooperation (PoC) signed between Department of Biotechnology (DBT, India) and Deutsche Forschungs gemeinschaft (DFG, Germany) in October 2012, the government agencies from both the countries have invited collaborative research proposals for support under the Indo-German (DBT-DFG) initiative on building "Institutional Partnerships". Proposals may only be made by researchers affiliated to research institutions/university faculties and departments recognised by the respective Indian and German funding organizations. The program "Grant to Support International Collaboration" complements other existing Indo-German scientific exchange programs by offering incremental funds for research grants in addition to mobility funding from both sides. The joint funding grant avenues include them mobility grants and bilateral workshops and seminars, research grants, Indo-German international research training groups and Indo-German collaborative research centres. The same will be in the field of biotechnology and covering disciplines such as medical biotechnology, agricultural biotechnology, innovative food and nutrition technology, medical devices and bioengineering, environmental biotechnology or any other area of mutual interest. The objectives of this scheme is to promote and strengthen the research cooperation in the field of biotechnology between the two countries, by providing funding to allow joint research activities for internationally excellent research in relevant areas of mutual interest and benefit to be derived from bilateral cooperation and with the desire to strengthen the research cooperation on the basis of equality. ]]> <![CDATA[Civil society groups urge Qiagen to look into misuse of TB Gold kit ]]> https://biospectrumindia.com/news/95/5554/civil-society-groups-urge-qiagen-to-look-into-misuse-of-tb-gold-kit-.html https://biospectrumindia.com/news/95/5554/civil-society-groups-urge-qiagen-to-look-into-misuse-of-tb-gold-kit-.html Thu, 30 May 2013 17:53:00 +0530 While the government of India banned the use of serodiagnostic antibody-based tests for TB in 2012, the letter from the Treatment Action Group (TAG) and members of the Global TB Community Advisory Board (TB CAB) as well as civil society in India, has pointed towards Qiagen's QuantiFERON-TB Gold, being used to detect active TB disease in the private sector (where serology use was rampant). "Because of the void created by the serology ban, it appears that private laboratories have essentially replaced the banned serological tests with "TB-Gold" and doctors now think this is a better serological test than the antibody enzyme-linked immunosorbent assays that existed until the ban", says the letter written to Mr Peer M Schatz, chief executive officer and managing director, Qiagen Benelux B.V. on May 14, 2013. "We urge you and your distributors to market your test as the label indicates and take action to stop the unethical, off-label use of the test for active TB. This is not only relevant for India but also for other high TB burden countries. For instance, we have heard that QuantiFERON-TB Gold is also used in the South African private sector for active TB diagnosis," the letter mentioned. As per TAG, the Global TB CAB and other representatives of affected communities, they will continue to monitor the situation in India and elsewhere by visiting random labs and talking to distributors and doctors. "We hope that such surveillance confirms that IGRAs are not being promoted for off-label use. We will be obligated to call attention to instances in which this is occurring, and also take up the matter with the the Indian Ministry of Health and Family Welfare and Indian regulatory agency," the letter concluded. The letter draws its base from a survey titled, 'Perspectives of Quantiferon TB Gold test among Indian practitioners' published in the Journal of Opthalmic Inflammation and Infection in early 2013, that determined the preferences and perspectives regarding the Quantiferon TB Gold test for the diagnosis of tuberculosis (TB) in India. The urvey was distributed among 46 uveitis specialists, rheumatologists, and pulmonologists with a minimum of 2 years experience in the management of tuberculosis, in order to restrict the respondents to specialists who have used this test in their practice in the diagnosis of tuberculosis. Topics included demographics, usage, logistics, effectiveness, and preferences related to the Quantiferon TB Gold test. The results of the survey were shocking. Among the 37 responders, there were 19 uveitis specialists, 9 rheumatologists, and 9 pulmonologists with the majority having more than 7 years of experience in treating tuberculosis. Latent TB was the most common type of tuberculosis reported by 81% of the responders. Although 92% agree that Quantiferon TB Gold assay is used for the diagnosis of latent TB, only 32% use this test always in their practice. Limiting factors include the higher cost (35.14%), limited data from countries endemic for TB and hence limited interpretation of results (32.43%), the inability to differentiate active and latent TB (32.43%), and technical issues related to the test (18.92%). A combination of the Mantoux test and Quantiferon TB Gold test was the preferred test for investigation in 51% of the responders rather than solo tests. The Indian Revised National TB Control Program (RNTCP) has discouraged the use of Interferon-Gamma Release Assays (IGRAs) for TB diagnosis, and a World Health Organization policy also states that IGRAs should not be used to diagnose active TB in high burden settings where the prevalence of latent TB infection (LTBI) is very high (nearly 40% of the Indian population is estimated to be latently infected and therefore positive by latent TB tests). "We are concerned that your test, which is indicated for LTBI detection only, is being used in an off-label manner, and are worried about the implications for individuals with suspected TB in India. We understand that you are marketing QuantiFERON-TB Gold as "TB Gold" (and not "Latent TB Gold"), which may lead users to believe it is the gold standard for active TB disease diagnosis." "There is great potential for this test to become a replacement for antibody blood tests that the Government of India (and WHO) has worked so hard to ban. We are now aware of other IGRAs being sold in India as "TB Platinum" and openly marketed for active TB." the letter explained, "The RNTCP has no program in place for treating people with LTBI, and even in the private sector it is very uncommon to see prescriptions for 6 - 9 months of isoniazid. Most providers in India do not treat LTBI, and there is considerable confusion in the minds of providers about the value and role of TB Gold in the Indian setting (as mentioned earlier, Babu K et al. in J Ophthal Inflamm Infect 2013). So this means that any LTBI test used in India will most likely be used to diagnose active TB disease. Even if private laboratories are educated about the need to restrict IGRAs for LBTI, they have no control over how doctors actually use the end results. We understand that India is a complicated environment to work in, but hope that you would agree that it does not absolve corporations of ensuring that you and your distributors are following ethical and globally accepted marketing practices." ]]> <![CDATA[HCG and BACC partner to form Milann fertility centre]]> https://biospectrumindia.com/news/95/8052/hcg-and-bacc-partner-to-form-milann-fertility-centre.html https://biospectrumindia.com/news/95/8052/hcg-and-bacc-partner-to-form-milann-fertility-centre.html Thu, 30 May 2013 17:42:30 +0530 HealthCare Global Enterprises (HCG) has partnered with the Bangalore Assisted Conception Centre (BACC), and has taken a majority stake in the company to create Milann - The Fertility Centre. Details of the stake holding into creation of Milann were not disclosed. HCG which is a focused cancer care major has now entered into infertility treatment space as part of its inorganic growth plan. BACC, operates four fertility centres across Bengaluru and these facilities will now come under the umbrella of Milann. "We are delighted to partner with one of the country's most accomplished fertility specialists, who has contributed immensely in the field of infertility treatment . We will build upon this expertise to help establish the nation's leading fertility care provider," said Dr BS Ajaikumar, chairman and CEO of HCG. According to Dr Kamini A Rao, fertility specialist and medical director, Milann, since HCG has been successful in creating a unique nationwide network of cancer care that makes the latest technology and the best expertise available to all. We look forward to joining hands with HCG to realize our dream of making the best practices in fertility care available and accessible across India. ]]> <![CDATA[Biogen employees rally in 11 cities to raise awareness about MS]]> https://biospectrumindia.com/news/95/3293/biogen-employees-rally-in-11-cities-to-raise-awareness-about-ms.html https://biospectrumindia.com/news/95/3293/biogen-employees-rally-in-11-cities-to-raise-awareness-about-ms.html Thu, 30 May 2013 17:28:19 +0530 To commemorate World Multiple Sclerosis Day, Biogen Idec India, the global leader in research and treatment of multiple sclerosis, observed World Multiple Sclerosis Day in India through interactive and educative road shows across India. As part of the initiative, employees rallied across 11 different cities viz Gurgaon, Fardiabad, Delhi, Ahmedabad, Kolkata, Mumbai, Bangalore, Chennai, Hyderabad, Cochin and Pune to educate people about Multiple Sclerosis (MS) and express solidarity with people suffering from MS. The day of service was designed to increase the role of employee volunteerism with focus on patients, healthcare providers and local communities. Wearing a MS tee and a wig, Biogen Idec employees interacted with the local community and distributed information pamphlets at parks, local market and busy streets. With the theme message of "Together let's fight MS," healthcare providers were also made aware about the significance of the day and importance of early diagnosis. The aim of the initiative was to raise awareness of MS, solicit public support for improving opportunities and outcomes for MS patients and create an environment where people can understand MS better. MS is an auto-immune disease in which the body attacks its own cells and tissues. Due to damage in the nerve layer i.e. myelin sheath, transmission of signals from the brain and spinal cord gets affected. The most common symptoms are weakness in the limbs, numbness, sudden loss of balance, blurred vision that may lead to paralysis. The disease mostly strikes youth at a time when are starting new careers, relationships or making plans for the future. Multiple sclerosis can be difficult to diagnose early in the course of the disease because symptoms often come and go - sometimes disappearing for months. According to estimates, there are between 100,000 - 200,000 multiple sclerosis patients in India, even though that there are no exact statistics on MS. Women are twice more likely to fall prey to MS than men. Genetic and environmental factors are thought to contribute to MS, but a specific cause for the disease hasn't been yet identified nor a permanent cure although certain disease modifying medications such as interferons and monoclonal antibodies can help reduce recurrent attacks and prevent disability in the long run. ]]> <![CDATA[ICRA: Market-based pricing to impact near-term pharma earnings]]> https://biospectrumindia.com/news/95/5793/icra-market-based-pricing-to-impact-near-term-pharma-earnings.html https://biospectrumindia.com/news/95/5793/icra-market-based-pricing-to-impact-near-term-pharma-earnings.html Thu, 30 May 2013 17:27:00 +0530 ICRA expects the latest proposed market-based pricing mechanism for the Indian pharmaceutical Industry would impact near term earnings of pharma companies with relatively higher dependence on the Indian market. With the National List of Essential Medicines (NLEM) estimated to cover almost 20 percent of the Rs 728 billion domestic formulation business, an expected price cut of 15-20 percent will erode the market by 3-4 percent. Its impact on earnings will be higher as much of this will directly eat into the relatively higher margin India business. According to ICRA, companies with higher dependence on the Indian market (i.e. Indian arm of MNCs, mid-size pharma companies), premium-pricing strategy and greater share of acute therapy segments (i.e. 70 percent of NLEM) will be impacted the most. Conversely, the impact of the new policy would not be substantial on companies that have sizeable share of earnings from regulated markets, especially the US generics. In ICRA's view, companies are likely to review their portfolios over the medium-to-longer term but in the near-term cost rationalization measures like scaling down promotional/marketing budgets and consolidating field force appear to be more achievable goals. Unlike earlier, price revisions (in line with change in WPI or otherwise for drugs that are not under NLEM) may become a common phenomenon now. The Department of Pharmaceuticals recently released a detailed note paving the way for the implementation of the proposed pricing policy for the Indian pharmaceutical industry. In line with the earlier proposal, the policy has adopted a market-based pricing mechanism where in the ceiling price for each branded drug or a generic version will be determined by taking a simple average of all drugs with market share equal to or greater than 1 percent. The policy will control prices of 348 drugs that are classified as "Essential" and form part of the National List of Essential Medicines (NLEM). The companies will be allowed to revise prices of these molecules once a year in line with the change in the Wholesale Price Index (WPI). For all other drugs (i.e. not in NLEM), an annual price hike of 10 percent will be allowed. To encourage investments in R&D, completely new innovations and even drugs developed through new processes or involving novel drug delivery mechanism will be exempt from price control for a period of five years. Having issued the detailed guidelines, the government will now notify the ceiling prices, post which the policy will come into effect in the next 45 days. Companies will have to adjust their MRPs within this period which would result in some inventory de-stocking/rationalization in the coming few months by the distribution channel. Overall, a market-based pricing mechanism is more acceptable to the industry and over a longer-period may limit the adverse impact on the industry. There would however be some challenges and uncertainties in its implementation. For instance, while the government has put in place certain measures to ensure availability of drugs, but events like sharp hike in prices input materials and consequently reduced viability could be a possible challenge for the government. The policy has also tightened the norms, for pricing drugs that involve any changes; especially combination therapies (involving even a single molecule from NLEM) will fall under price control. Besides benefitting the consumers, the policy's key positive is the shift that it brings in from a cost-based approach to a market-based mechanism, which according to many market players is expected to bring in greater transparency, says ICRA. ]]> <![CDATA[Global biosimilar market to touch $2-3 billion by 2015, says Fitch report]]> https://biospectrumindia.com/news/95/3273/global-biosimilar-market-to-touch-2-3-billion-by-2015-says-fitch-report.html https://biospectrumindia.com/news/95/3273/global-biosimilar-market-to-touch-2-3-billion-by-2015-says-fitch-report.html Wed, 29 May 2013 18:04:00 +0530 According to a new Fitch Ratings report, the global pharmaceutical biosimilar market is set for significant growth over the coming years. However, regulatory uncertainties will likely temper growth over the medium term. The global biosimilars market is estimated to be $2-3 billion by 2015, concentrated mainly in Europe. Fitch expects the biosimilar market will grow significantly over time, given expanding efforts to develop reference biological therapeutics. Fitch also believes that sponsors will need to invest significant resources, given that the complex nature of biological therapeutics demands more analysis than that of the traditional small-molecule generic market. The FDA issued draft guidance in February 2012 on how the industry can gain regulatory approval to market biosimilar drugs, although the agency has not yet finalized its guidance. Fitch believes that it could reflect stakeholder feedback, which largely appears to be focused on gaining more clarity or specificity regarding the approval process. Fitch also expects that price discounts and market share gains of biosimilars will be less than those in the traditional generic market, since most approved biosimilars will probably not be interchangeable with the original reference therapeutic early on. Nevertheless, there will be financial opportunities for biosimilar sponsors, pharmacy benefit managers and drug distributors. Conversely, innovators will face some headwinds. ]]> <![CDATA[Jubilant Life Sciences to split business into two verticals]]> https://biospectrumindia.com/news/95/3255/jubilant-life-sciences-to-split-business-into-two-verticals.html https://biospectrumindia.com/news/95/3255/jubilant-life-sciences-to-split-business-into-two-verticals.html Wed, 29 May 2013 17:09:07 +0530 The board of directors of Jubilant Life Sciences has decided to consolidate its pharma business into two subsidaries namely pharma and drug discovery. It will explore the possibility of listing the pharma business so as to raise resources. In a filing with the stock exchanges, the company stated that its board of directors, on May 28, 2013 gave its nod to consolidate the pharma segment under two separate verticals bringing Active Pharmaceuticals Ingredients, Solid Dosage Form, radio pharmaceuticals, allergic extracts, sterile injectible and ointment, cream and liquid businesses under the fold of pharma business, and drug discovery businesses. According to the company, it has also constituted a committee to explore, identify and implement the options and opportunities of raising money by listing the pharma business for its growth and reduction of overall consolidated debt of the company. Click here to read about Jubilant's 2012-13 Q4 performance ]]> <![CDATA[Apollo Hospitals launches Centre for Liver Disease and Transplantation ]]> https://biospectrumindia.com/news/95/3193/apollo-hospitals-launches-centre-for-liver-disease-and-transplantation-.html https://biospectrumindia.com/news/95/3193/apollo-hospitals-launches-centre-for-liver-disease-and-transplantation-.html Wed, 29 May 2013 15:09:43 +0530 Apollo Hospitals, a pioneer in providing quality healthcare, have introduced the Centre for Liver Disease and Transplantation (CLDT) in Bangalore with an aim to bring advanced liver care closer to home for the patients in the city. CLDT plans to make their services available via multidisciplinary "Liver Clinics" that are aimed to become a one stop solution for patients with liver and hepatobiliary-pancreatic disorders. Liver failure is a potentially fatal condition in which the liver progressively stops performing its function resulting in episodes of jaundice, accumulation of fluid in the body, blood vomiting and confusion. Conditions such as hepatitis B or hepatitis C infection, excess alcohol consumption, diseases such as primary biliary cirrhosis and primary sclerosing cholangitis can cause this state. A liver transplant is recommended when all other treatment options fail and then on inaction could be fatal. The purpose of the transplantation is to replace the diseased liver with a healthy liver. Ideally, after a transplant, a patient will be free from disease, and can lead a fairly normal life. At Apollo Hospitals Bangalore, the services offered will include Liver and multivisceral transplantation for all age groups and for the full spectrum of liver ailments. Additionally, patients with various forms of liver, biliary and pancreatic cancers can avail services related to advanced radiologic and minimally surgical (laparoscopic surgery, radiofrequency ablations) interventions. Hepatology and interventional gastroenterology services at CLDT will benefit patients with liver disease. "Liver disease is a common and serious problem in our country. Liver transplantation is surgery that is performed to remove a diseased liver in order to replace it with a healthy one. Such surgeries have been done for over 38 years. Several people who have had liver transplants go on to lead perfectly normal lives", said Dr Anand Khakhar, senior consultant, liver transplant and hepatobiliary surgery, Apollo Hospitals Group. There is a noticeable rise in the cases of liver diseases in India which will result in a greater need for treatment in the coming future. As a pioneer in the healthcare sector, Apollo Hospitals is fortifying its facilities throughout the country to meet and battle this need. After establishing successful transplant programs at Chennai and Hyderabad, these services are now available full time at CLDT in Apollo Hospitals, Bangalore. Apollo Hospitals' comprehensive liver transplant care program aims to provide effective health care by connecting to people dealing with liver disease. The CLDT, Apollo Hospitals, will be equipped with the state-of-the-art technology for liver surgery. The CLDT in Bangalore features a multidisciplinary team of eminent doctors trained at the best centres in the world with appropriately trained therapists to provide a 360 degree care for all stages of liver and digestive diseases. ]]> <![CDATA[AstraZeneca to acquire Omthera Pharmaceuticals]]> https://biospectrumindia.com/news/95/8219/astrazeneca-to-acquire-omthera-pharmaceuticals.html https://biospectrumindia.com/news/95/8219/astrazeneca-to-acquire-omthera-pharmaceuticals.html Tue, 28 May 2013 18:01:53 +0530 AstraZeneca has entered into a definitive agreement to acquire New Jersey-based, Omthera Pharmaceuticals, a specialty pharmaceutical company focused on the development and commercialization of new therapies for abnormal levels of lipids in the blood, referred to as dyslipidemia. Under the terms of the agreement, AstraZeneca will acquire Omthera for $12.70 per share, or approximately $323 million, which has an enterprise value of approximately $260 million after incorporating Omthera's cash balances of approximately $63 million. This represents a premium of 88 percent on Omthera's closing price on May 24, 2013. In addition to the cash payment, each Omthera shareholder will receive Contingent Value Rights (CVRs) of up to approximately $4.70 per share, equating to approximately $120 million in total, if specified milestones related to Epanova are achieved, or if a milestone related to global net sales is achieved. This will bring the total potential acquisition cost to approximately $443 million. Omthera's investigational product, Epanova, for the potential treatment of patients with very high triglycerides, is a novel omega-3 free fatty acid composition that has been shown to bolster levels of eicosapentaenoic acid and docosahexaenoic acid significantly in the blood. In studies to date, it has been shown to reduce triglyceride levels and improve other key lipid parameters and is expected to increase convenience for patients by providing both two and four gram once-a-day doses with or without meals. Omthera has completed pharmacokinetic and phase III clinical studies to investigate the safety and efficacy profile of Epanova, a coated soft gelatin capsule containing a complex mixture of polyunsaturated free fatty acids derived from fish oils. In 2012, Omthera reported positive results from two phase III trials (EVOLVE and ESPRIT) examining the effectiveness of Epanova in lowering very high triglycerides, and in reducing non-HDL cholesterol in combination with a statin for patients with high triglycerides. Both trials were conducted under a special protocol assessment with the US FDA. Omthera is expected to file a New Drug Application (NDA) in the US for Epanova in mid-2013 for patients with severe hypertriglyceridemia (triglyceride levels greater than or equal to 500mg/dL), with regulatory filings in other markets to follow. AstraZeneca aims to file a supplemental NDA as soon as possible for Epanova as a treatment for patients with mixed dyslipidemia (triglyceride levels of 200-499mg/dl), as well as in a fixed dose combination with CRESTOR (rosuvastatin calcium) for those mixed dyslipidemia patients at high risk of a cardiovascular event. AstraZeneca intends to pursue a large-scale cardiovascular outcomes trial for Epanova in combination with statins. Pascal Soriot, chief executive officer of AstraZeneca said, "The number of people with elevated triglyceride levels is rising rapidly across the world, due in part to the increasing prevalence of obesity and diabetes. There is a clear need for effective and convenient alternatives to some of the existing treatments. Epanova offers real potential both as a distinctive monotherapy for the treatment of hypertriglyceridemia and in combination with Crestor for patients at high risk of adverse cardiovascular events. This is an exciting acquisition that clearly complements our existing portfolio in cardiovascular and metabolic disease, one of our core therapy areas." Mr Gerald L Wisler, president and CEO, board member, and co-founder of Omthera, commented, "We are delighted to be joining AstraZeneca, a leading pharmaceutical company with a proven track record in the development and commercialization of global brands in the area of cardiovascular disease. We believe strongly that AstraZeneca can maximise the value of Epanova not only as a monotherapy treatment for dyslipidemia but also as a treatment for cardiovascular disease in combination with Crestor." The board of directors of Omthera has unanimously approved the terms of the agreement, and has recommended that its shareholders approve the transaction. AstraZeneca's board has also approved the terms of the agreement. Subject to the approval of Omthera's shareholders as well as other conditions including customary regulatory approvals, the transaction is expected to close in the third quarter of 2013. Omthera's shareholders representing approximately 60% of the current total shares outstanding have entered into a voting agreement with AstraZeneca to vote in favour of the transaction, subject to the conditions set out in the voting agreement. AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of cardiovascular, metabolic, respiratory, inflammation, autoimmune, oncology, infection and neuroscience diseases. ]]> <![CDATA[Cyclists and celebrity rally to raise awareness about MS]]> https://biospectrumindia.com/news/95/1414/cyclists-and-celebrity-rally-to-raise-awareness-about-ms.html https://biospectrumindia.com/news/95/1414/cyclists-and-celebrity-rally-to-raise-awareness-about-ms.html Tue, 28 May 2013 16:48:54 +0530 To commemorate World Multiple Sclerosis Day, a 20 km long bicycle rally was organized by Mumbai Chapter of Multiple Sclerosis Society of India in association with Bandra Cycle Club. Carrying flags and dressed in orange, the rally which started early morning from Lucky Bandra to Worli Sea Face and back witnessed hundreds of people cheering alongside members of civil society to voice their concern and support for MS patients. Celebrities included MS Good Will Ambassador Mr Milind Soman and MTV Roadies Judge Mr Raghu Ram who led the rally from the front. According to Ms Sheela Chitnis, chairperson, MSSI Mumbai Chapter, "The event is more than a ride-it's motivation, solidarity, personal accomplishment, and the knowledge that we can make a difference in the life of youth, imparting them with the promise of a better, healthier future." Multiple Sclerosis (MS) is an auto-immune disease in which the body attacks its own cells and tissues. Due to damage in the nerve layer i.e. myelin sheath, transmission of signals from the brain and spinal cord gets affected. The most common symptoms are weakness in the limbs, numbness, sudden loss of balance, blurred vision that may lead to paralysis. The disease mostly strikes youth at a time when are starting new careers, relationships or making plans for the future. Dr Arun B Shah, consultant, neurologist, Breach Candy Hospital, Mumbai said, "There has been a steady increase in the number of neurological diseases such as Multiple Sclerosis in recent times. The numbers are rising apparently due to increased awareness or increased availability of imaging facilities such as MRI scans. This chronic neurological condition causes long-term disability if left untreated. Also, such patients suffer severe pain and go through mental as well as physical trauma. It becomes crucial to give support to such patients with high priority." On the occasion, Mr Milind Soman, model and actor said, "It's really nice to see the sheer enthusiasm, love and energy of the people. It really makes me feel good. I encourage all Mumbaikars to support the cause so that people with MS are able to lead the best possible life and with dignity." According to estimates, there are between 100,000-200,000 multiple sclerosis patients in India, even though that there are no exact statistics on MS. Women are twice more likely to fall prey to MS than men. Genetic and environmental factors are thought to contribute to MS, but a specific cause for the disease hasn't been yet identified nor a permanent cure although certain disease modifying medications such as interferon and monoclonal antibodies help reduce recurrent attacks and prevent disability. The Multiple Sclerosis Society of India (MSSI) is a charitable, non-profit voluntary organization founded in the year 1985. The organization proactively works towards encouraging MS patients to lead a more productive life through counseling, rehabilitation and support through its various state chapters. ]]> <![CDATA[Wockhardt crosses the billion dollar mark with $1 billion in sales]]> https://biospectrumindia.com/news/95/7037/wockhardt-crosses-the-billion-dollar-mark-with-1-billion-in-sales.html https://biospectrumindia.com/news/95/7037/wockhardt-crosses-the-billion-dollar-mark-with-1-billion-in-sales.html Mon, 27 May 2013 18:30:00 +0530 Wockhardt reported its FY 2012-13 results with a 52 percent growth in operating Profit at Rs 2,091 crore with a operating profit margin at 37.3 percent, one of the highest in the industry. The consolidated revenues stood at Rs 5,610 crore and the Profit After Tax was seen at Rs 1,594 crore while the Profit After Tax margin at 28.4 percent. Dr Habil Khorakiwala, founder chairman and group CEO, Wockhardt said, "The strong growth that we have achieved in this financial year is the result of a robust global strategy,continued focus on R&D and the commitment and confidence of Team Wockhardt. Driving profitable growth is integral to our business strategy." The Profit After Tax for Q4FY13 stood at Rs 335 crore compared to a loss of Rs 192 crore reported in corresponding quarter in the previous year. The Operating Profit was at Rs 546 crore for Q4FY13, representing a growth of 32% over corresponding quarter in the previous year. Operating Profit margins were at 36.7% for Q4FY13. Consolidated revenues grew by 26% to Rs.1486 crore over the corresponding quarter in the previous year. Research and Development continues to be at the core for Wockhardt. During the year 2012-13 R&D expenses stood at 6.7% of sales compared to 5.7% of sales in 2011-12. Wockhardt filed 20 new product applications with USFDA in FY 2012-13 and received approvals for 12 products during the year. The cumulative products pending approval with USFDA stands at 46 as on March 2013. Wockhardt also filed for 162 patents during the year taking the cumulative filings to 1733 and has been granted 52 patents during the year taking the cumulative patents granted to 206. Wockhardt won the Pharmexcil Award for the highest number of patents filed for the 4th year in a row. Dr Habil Khorakiwala, further added, "R&D continues to be at the core of the organization. We have undertaken significant investments in talent and new technologies at R&D to keep it at the forefront of latest developments. With R&D at 6.7% of sales, the organization maintains one of the best investments in the industry towards its R&D programs." ]]> <![CDATA[CCEA approves World Bank-funded HIV/AIDS control project ]]> https://biospectrumindia.com/news/95/1012/ccea-approves-world-bank-funded-hiv-aids-control-project-.html https://biospectrumindia.com/news/95/1012/ccea-approves-world-bank-funded-hiv-aids-control-project-.html Mon, 27 May 2013 14:06:00 +0530 The Cabinet Committee on Economic Affairs on May 23, 2013 approved a proposal by the Department of AIDS Control, Ministry of Health and Family Welfare for the implementation of National AIDS Control Support Project (NACSP) under the National AIDS Control Program (NACP) for an amount of Rs 2,550 crore. NACP is financed by the government of India and the World Bank in equal proportion. This project will contribute towards intensifying and consolidating prevention services with a focus on highly vulnerable populations, high risk groups and bridge population. Strengthening Behaviour Change Communication (BCC) and demand generation, institutional strengthening and financial management. This would help in providing the desired impetus required for further consolidation of gains made in containing the spread of HIV infection in the country. The primary objective of the project is to increase safe behaviour among high risk groups in pursuance of the national goal of accelerated reversal of the HIV epidemic by 2017. The primary focus of the project activities would be strengthening and scaling up of prevention interventions and related BCC strategies for sub-groups of population identified to be most-at-risk by the NACP. These include Female Sex Workers (FSW), Men who have sex with Men (MSM), Transgender (TG) / Hijra populations and Injecting Drug Users (IDU). The project would also support the planned expansion and consolidation of tailored interventions for other at-risk populations, including migrant workers and truckers which play a critical role in the transmission dynamics of HIV in the country. The BCC strategies developed under the project would provide emphasis on demand generation for prevention services among high risk groups and vulnerable populations, including a specific focus on youth. This component would also address the need for reduction of stigma associated with HIV by focused IEC to change the prevailing attitudes and perceptions. The NACP of India has been a remarkable success in its third phase (2007-12) and the country is on track to meet the Millennium Development Goal (MDG) for HIV prevention and control. Over the last decade, there has been a reduction of 57 percent in the new HIV infections and 29 percent reduction in AIDS-related deaths. This has led to the recognition of India`s HIV program as a global best practice, and has been an important factor behind the decision of the World Bank to support the prevention component of the HIV program, at a time of global financial meltdown and decreasing support from international donor agencies. ]]> <![CDATA[New drug pricing policy to cause value erosion of Rs1,600 crore]]> https://biospectrumindia.com/news/95/2988/new-drug-pricing-policy-to-cause-value-erosion-of-rs1600-crore.html https://biospectrumindia.com/news/95/2988/new-drug-pricing-policy-to-cause-value-erosion-of-rs1600-crore.html Fri, 24 May 2013 17:33:00 +0530 IMS Health has estimated the scope of the National List of Essential Medicines (NLEM) pricing policy is likely to cover almost 18 percent of the retail pharmaceutical market. Coupling this with the Drug Price Control Order (DPCO) which is likely to remain in place for some time post NLEM implementation, the scope of the combined price controlled segment would be approximately 30 percent of the market, during this period. Mr Amit Backliwal, general manager, South East, IMS Health has said, "Based on the DPCO 2013, IMS Health has estimated that the value erosion of the pharmaceutical market would be to the tune of approximately Rs 1,600 crore (approximately 2.2 percent of the current pharmaceutical market), post implementation." The analysis from IMS Health also indicated that the value erosion on NLEM for MNC pharma companies would be 18 percent in comparison to 9 percent for Indian companies. An internal analysis based on IMS Health's Total Sales Audit, March 2013, they estimated that the contribution from these medicines (approximately Rs 13,000 crore), to the retail Indian pharmaceutical market (Rs 72,762 crore) is approximately 18 percent. IMS Health added that some of the medicines (like high-end oncology/hospital products) listed under NLEM do not have adequate representation in their sales audits and are consequently excluded from this analysis. The resultant impact though of price erosion in these categories would not substantially change the overall picture. ]]> <![CDATA[Daiichi allegations baseless: Singh brothers ]]> https://biospectrumindia.com/news/95/8070/daiichi-allegations-baseless-singh-brothers-.html https://biospectrumindia.com/news/95/8070/daiichi-allegations-baseless-singh-brothers-.html Fri, 24 May 2013 12:54:00 +0530 A day after Daiichi Sankyo's allegations of concealment and misrepresentation by the certain former shareholders of Ranbaxy on May 22, 2013, the Singh brothers (Malvinder and Shivinder) have termed these as completely false and designed to divert attention away from Daiichi Sankyo's own failures to protect itself and its shareholders in the negotiations and agreement with the Singh family shareholders of Ranbaxy. The counter statement from Singh family that came on late evening of May 23, 2013, clearly mentioned that the phrase 'former shareholders' 'is an obvious reference to the members and companies of the Singh family who were shareholders of Ranbaxy. Earlier Daiichi had accused them indirectly of concealing and misrepresenting critical information concerning the US Department of Justice (DOJ) and FDA investigations. According to Singh family, Daiichi Sankyo purchased their interests in Ranbaxy in 2008 after a long negotiation process, as is typical of deals of this magnitude, and after conducting full due diligence on the affairs of Ranbaxy. The negotiations on behalf of Daiichi Sankyo were led by Mr Takashi Shoda, Daiichi Sankyo's current representative director and chairman and Dr Tsutomu Une, executive director, who is also the current chairman of Ranbaxy. They and Daiichi Sankyo were legally advised. "At every step of the way during the negotiation process, Daiichi Sankyo and its representatives were made aware of the on-going US FDA and DOJ investigations. They were also given full access to the documents at Ranbaxy pertaining to US FDA and DOJ investigations," mentioned the statement. It goes on to add, "Daiichi Sankyo went in to the deal after satisfying itself with its due diligence, with knowledge of the US DOJ and FDA investigations and with the benefit of legal advice." It reminded Daiichi that it was upon their request that Malvinder had agreed to continue at Ranbaxy for a period of five years. Malvinder left Ranbaxy in the middle of 2009. When he left, Dr Tsutomu Une of Daiichi Sankyo sent him a personal letter of appreciation to thank him for the many valuable contributions made by him and the Singh family to Ranbaxy. In that letter, Dr Une had mentioned, "On behalf of the board members of Ranbaxy Laboratories Limited, we greatly appreciate the many valuable contributions made by you and your family to Ranbaxy. Under the leadership of your family, Ranbaxy has grown from a small pharmaceutical company providing pharmaceutical products to the people of India in the early years of the last century to an international generics giant that today has sales of several billion dollars and customers on every continent and competes internationally with the best in the industry." Again in April 2012, Malvinder was invited by Ranbaxy to attend a launch of Ranbaxy's new product. Dr Une met Malvinder at that launch but as per Singh family, there was no suggestion by Dr Une or anyone else on behalf of Ranbaxy or Daiichi Sankyo at that time that there was any concealment or misrepresentation. "It was recently reported that Ranbaxy had entered into a settlement agreement with the US FDA and DOJ in relation to their investigations and that under that settlement agreement, Ranbaxy agreed to pay large penalties to the US FDA and DOJ. The decision to enter into that settlement agreement was made by Ranbaxy and had nothing to do with the Singh family which was not even consulted by Daiichi Sankyo/Ranbaxy." "It is unfortunate that having made that decision, Ranbaxy's largest shareholder, Daichii Sankyo, is now trying to desperately shift the blame as regards Ranbaxy's current situation away from itself. That is, of course, very convenient," concluded the statement. With the Singh brothers openly countering the veiled reference to their alleged involvement in concealing facts, industry analysts are expecting Daiichi too to explain their point of view further. ]]> <![CDATA[Daiichi Sankyo may sue Ranbaxy stakeholders]]> https://biospectrumindia.com/news/95/3633/daiichi-sankyo-may-sue-ranbaxy-stakeholders.html https://biospectrumindia.com/news/95/3633/daiichi-sankyo-may-sue-ranbaxy-stakeholders.html Thu, 23 May 2013 18:18:28 +0530 While Ranbaxy is still reeling from the what is the largest settlement by any generic company in the US for violating the FDCA(Food, Drug and Cosmetic Act), Daiichi Sankyo, its parent firm have indicated that it is looking into legal options against key stakeholders from Ranbaxy. Tokyo based Daachi Sankyo, which took over Ranbaxy in 2008, has stated that," Daiichi Sankyo believes that certain former shareholders of Ranbaxy concealed and misrepresented critical information concerning the U.S. DOJ and FDA investigations. Daiichi Sankyo is currently pursuing its available legal remedies and cannot comment further on the subject at this time. " The $500 million settlement included both the civil and criminal cases against the manufacturer for malpractices and in data integrity and manufacturing processes at certain Ranbaxy facilities in India. The settlement also awarded Dinesh Thakur, the whistleblower who helped USFDA uncover evidence against malpractices, $48.6 million. Meanwhile,in a bid to clean up their act, Ranbaxy today highlighted some of the major specific actions the company has been taking in recent years to address certain conduct of the past and to ensure the safety and efficacy of all Ranbaxy products currently available in the global market. These actions include,a complete reconstitution of the Board of Directors and Executive Management team. Also plans were announced for enhancing its compliance procedures and policies;upgrading its business and manufacturing processes; building a culture of accountability and excellence across all levels of the organization. Arun Sawhney, CEO & Managing Director, Ranbaxy, stated, "Ranbaxy is a different company today. The steps we have taken over the recent years reflect the wide-ranging efforts of the current board and management to address certain conduct of the past and ensure that Ranbaxy moves forward with integrity and professionalism in everything we do. We are fully committed to upholding the high standards that patients, prescribers and all other stakeholders expect." Sawhney added, "All Ranbaxy products currently in the global market are safe and effective, and we remain focused on our philosophy of 'Quality and Patients First.' In the recent years we have made significant improvements in the way we conduct our business to ensure greater quality control and have made investments of over US$ 300 million in our manufacturing facilities to install state-of-the-art technologies. We have also instituted a rigorous new Code of Conduct for all Ranbaxy employees, with clear accountability for compliance." Daiichi Sankyo added in their statement that it would also continue to support Ranbaxy in its efforts to address and correct the conduct of the past which led to the investigations by the U.S. Department of Justice ("DOJ") and the U.S. Food and Drug Administration ("USFDA"). It said,"These efforts include significant changes to Ranbaxy's management, culture, operations and compliance." ]]> <![CDATA[GE launches healthcare mission on wheels]]> https://biospectrumindia.com/news/95/4144/ge-launches-healthcare-mission-on-wheels.html https://biospectrumindia.com/news/95/4144/ge-launches-healthcare-mission-on-wheels.html Wed, 22 May 2013 12:53:18 +0530 GE Healthcare has launched its first healthcare technology experiential lounge on wheels - "Mission Healthier India". A specially designed vehicle fitted with high end, affordable healthcare technologies from GE was flagged off by Mr SM Velusamy, Worshipful Mayor, Coimbatore Corporation, Mr S Ganesh Prasad, director, Ultrasound, GE Healthcare South Asia and Mr Asuthosh Banerjee, general manager, Life Care Solutions, GE Healthcare South Asia. Speaking on the occasion, Mr S Ganesh Prasad, director, Ultrasound, GE Healthcare South Asia said, "Access to advanced diagnostic technology can make a huge difference in early detection and treatment of diseases and conditions. However, proliferation of such technologies has been dismal in India due to its high cost and low awareness. Mission Healthier India is an example of how we are at work for a healthier India. Our mission will allow clinicians and public to experience GE's advanced and affordable technologies at their doorsteps and learn how they can put these technologies to use for saving precious lives". The mission aims to introduce high end technology to hospitals, nursing homes and clinics in 50 towns of Tamil Nadu at their doorsteps and to create awareness on the usage of technology in early detection of diseases and enablement of saving lives. The mission also aims to create awareness amongst public through technology experience and information dissemination. Through this mission, GE Healthcare hopes to cover 5,000 clinicians and 100,000 people in the two-month tour of Tamil Nadu before embarking on similar tours in rest of India. The Mission Healthier India provides a closer view of technologies that can aid three key care areas that small towns and villages are challenged with - women and maternal infant health, cardiac diseases and critical care. The mother and infant care technologies include ultrasound imaging systems for diagnosing health of baby and mother during pregnancy, infant care technologies like Embrace for providing mother's womb like warmth, Lullaby LED Phototherapy system for treating neonatal jaundice, MAC series of portable, battery operated ECG systems for early detection of cardiac diseases and critical care tools required for monitoring and supporting critically ill patients, and reducing infections in ICUs. Experts from GE Healthcare will provide hands-on demonstrations on usage of these advanced medical technologies. ]]> <![CDATA[GADVASU gets international patent for innovation in diagnosis of infectious diseases]]> https://biospectrumindia.com/news/95/5388/gadvasu-gets-international-patent-for-innovation-in-diagnosis-of-infectious-diseases.html https://biospectrumindia.com/news/95/5388/gadvasu-gets-international-patent-for-innovation-in-diagnosis-of-infectious-diseases.html Wed, 22 May 2013 12:49:58 +0530 Guru Angad Dev Veterinary and Animal Sciences University (GADVASU), Ludhiana has been granted a South African patent on an innovation in diagnosis of infectious diseases. Microbial antigenic particles can bind specifically to antibodies of corresponding specificity present in the serum of infected man or animal to form a clump called agglutinate. This is the basis of diagnostic tests employed for several bacterial and viral diseases of man and animals. However, inability to detect small clumps can sometimes lead to false negative result and aggregates of antigen particles alone can often lead to false positive results. The new diagnostic test called Super agglutination test provides an ingenious solution to the problem of false positive and false negative results common with the available diagnostic tests and kits employed for diagnosis of a large number of infectious diseases of animals and humans, including important zoonotic diseases like brucellosis (the rose bengal plate test) and salmonellosis, transmissible from animals to humans. A commercial kit for diagnosis of HIV infection currently being used worldwide is also based on the prevalent test procedure and can be improved by the new modifications. The idea behind the breakthrough is that of Dr Hari Mohan Saxena, professor of immunology in the veterinary microbiology department of GADVASU. A research paper on the new test authored by Dr HM Saxena and Dr Paviter Kaur (assistant professor in the same department) has recently been published in the International Journal of Tropical Disease and Health. In a comparative study undertaken by Dr Shubhada Chothe, a post-graduate student under the supervision of Dr Saxena, the new test was found to be superior to the conventional tests commonly used in screening cattle and buffaloes for brucellosis. It was found comparable to, and in some respects better than even some of the advanced laboratory based tests. The new test is simple, easy to perform, cheap and field applicable in rural or remote areas and can be applied to several bacterial and viral diseases. The new method of diagnosis was recently selected among the "Top 100 innovations" in the India Innovation Growth Program 2013 jointly organized by the Department of Science and Technology, Ministry of Science and Technology, Government of India, Martin Lockheed, Federation of Indian Chambers of Commerce and Industry, Indo-US Science and Technology Forum, Stanford Graduate School of Business and IC2 Institute of Texas University, US, respectively. Applications for patent for this invention have already been filed in the US, Europe, China and India. ]]> <![CDATA[Govt awards farmers engaged in protecting plant genetic resources]]> https://biospectrumindia.com/news/95/3284/govt-awards-farmers-engaged-in-protecting-plant-genetic-resources.html https://biospectrumindia.com/news/95/3284/govt-awards-farmers-engaged-in-protecting-plant-genetic-resources.html Wed, 22 May 2013 10:55:00 +0530 The Agriculture and Food Processing Industries Minister, Mr Sharad Pawar will confer awards on four farming communities for their outstanding work in conservation of genetic resources, in a ceremony today on May 21, 2013. These awards, carrying a cash prize of Rs 10 lakh each, have been instituted by the Protection of Plant Varieties and Farmers' Right Authority (PPV & FR), will be given away at a function to be held at New Delhi. In addition, 10 farmers will receive award and cash prize of Rs 1 lakh each. Fifteen farmers and farming communities will be given a citation to recognize their contribution. The awards are being given since 2009 to farming communities and farmers, particularly the tribal and rural ones, engaged in conservation, improvement and preservation of genetic resources of economic plants and their wild relatives particularly in the areas identified as agro-biodiversity hotspots. The awardees of four Plant Genome Saviour Community Awards are (i) Seed Saver Farmers Group, Pune (Maharashtra), Sanjeevini Rural Development Society, Vishakapatnam (Andhra Pradesh), Deepaoli Women's Self Help Group, Thiruvannamalai (Tamil Nadu) and Akampadam Chimpachala Punchakkadu Padasekhara Samithi representing rice farming communities in Palakkad (Kerala). The 10 farmers to be awarded Plant Genome Saviour Farmer Rewards are: Mr P Devakanta, Imphal (Manipur), Mr Maha Veer Singh Arya, Churu (Rajasthan), Mr N Vasavan, Kannur (Kerala), Mr Purnanand Venkatesh Bhat, Uttar Kannada (Karnataka), Mr Jai Prakash Singh, Jhakini, Varanasi (Uttar Pradesh), Mr Pravat Ranjan Dey, Panpara, Nadia (West Bengal), Ushagram Trust, Bimagar, Nadia (West Bengal), Mr Chandra Shekhar Singh, Varanasi (Uttar Pradesh), Mr Ciby George Kallingal, Pattikkad, Thrissur (Kerala) and Mr Narendra Singh Sipani, Mandsour (Madhya Pradesh). ]]> <![CDATA[India, UK strengthen ties by signing healthcare MoU]]> https://biospectrumindia.com/news/95/3269/india-uk-strengthen-ties-by-signing-healthcare-mou.html https://biospectrumindia.com/news/95/3269/india-uk-strengthen-ties-by-signing-healthcare-mou.html Tue, 21 May 2013 13:16:34 +0530 The Union minister of Health and Family Welfare of India, Mr Ghulam Nabi Azad and the Secretary of State for Health, UK, Mr Jeremy Richard Hunt have signed an MoU on cooperation in the field of health sector at Geneva between the Government of India and the Government of the United Kingdom of Great Britain and Northern Ireland. Mr Azad stated that the agreement between India and UK will promote wide-ranging cooperation in the health sector between the two countries and spur the exchange of information and expertise for the common good of people. The areas identified for cooperation in the MOU include promoting exchange on healthcare policy in India and the UK; human resources for health; regulatory issues; health technology development: primary healthcare; strengthening of public infrastructure and capacity; health security, including cooperation on infectious diseases, emerging infections and drug resistance. Describing the agreement as a historic event and a great milestone, Mr Azad noted with optimism that this agreement is going to usher in a new era of cooperation in the health sector between the two countries. India has been a strategic partner to the UK and a recipient of UK's bilateral assistance in the form of grants since 1975. The priority for the DFID, the aid agency of the UK Department for International Development and Government of India partnership has been improvement of maternal and child health and reducing the burden of communicable diseases. Mr Azad also noted with satisfaction that Department of Health Research, Government of India and National Institute of Clinical Excellence (NICE), UK are in the process of signing an agreement for collaboration in areas relating to medical and health technology assessment. Recalling the historic relations that the two countries share, Mr Azad noted that the signing of this agreement demonstrates the commitment of both the countries to work closely with each other to further cement their strong relations. ]]> <![CDATA[Novartis' Arogya Parivar program wins award]]> https://biospectrumindia.com/news/95/7084/novartis-arogya-parivar-program-wins-award.html https://biospectrumindia.com/news/95/7084/novartis-arogya-parivar-program-wins-award.html Mon, 20 May 2013 17:42:41 +0530 GBCHealth, a coalition of more than 230 private sector companies working to improve global health, has awarded the Novartis' Arogya Parivar program the Business Action on Health Award for Application of Core Competence. Arogya Parivar is Novartis' sustainable business model that makes affordable, high-quality medicines accessible to underserved millions in India. The program also expands access to health education and consultations in remote villages. "We are proud to be recognized by GBCHealth for our Arogya Parivar program," said Mr Joe Jimenez, Novartis chief executive officer. "Arogya Parivar is an important part of the work Novartis is doing around the world to develop sustainable solutions that address the unmet medical needs of people in developing nations. Through our social ventures programs, we're making a difference by encouraging better health and at the same time driving local economic growth. We expect Arogya Parivar to have an enduring impact in India and look forward to extending the model to other developing economies." Arogya Parivar, meaning "Healthy Family" in Hindi, is a for-profit social business developed by Novartis that adapts a market-based approach to improve healthcare access for India's rural poor. Novartis trains health educators, who teach communities about health and disease prevention, and sales supervisors, who increase local medicine access across several therapeutic areas by informing local pharmacists about products. Since launching Arogya Parivar in 2007, Novartis has trained more than 500 health educators and supervisors and improved access to healthcare for 42 million patients across 33,000 villages in India. As a result of the positive impact of Arogya Parivar, Novartis is working to further expand the social business model in 2014. Arogya Parivar is one example of a Novartis "social venture" approach. Social ventures build local, sustainable solutions to address healthcare challenges in emerging markets. These programs go beyond medicine, donations, and price reductions, by tackling larger societal issues that impact access to healthcare: education, infrastructure and distribution. ]]> <![CDATA[â€œWe are one among the few to produce next generation enzymesâ€?]]> https://biospectrumindia.com/news/95/8125/we-are-one-among-the-few-to-produce-next-generation-enzymes.html https://biospectrumindia.com/news/95/8125/we-are-one-among-the-few-to-produce-next-generation-enzymes.html Mon, 20 May 2013 13:00:00 +0530 "Things are changing globally and chemicals are being replaced by the biological products," says Mr Satish Verma, managing director, Fermenta Biotech, who feels that the prevailing work culture in India is much different when compared to other nations. Adding further he calls for a strong introspection. "We know that we are not leading the conversation in the biotech space as Europe and the US are more proactive. Also, in this sector, the awareness at policy making level is certainly lacking. The regulations are very complex here. So we have to do a lot of thinking here." Mentioning about the unique operations of Fermenta Biotech, which has filed national and patent co-operation treaty applications for novel products and processes in a number of countries, Mr Verma commented, "We are among few in the world to produce next-generation enzymes with patented applications. The company enjoys a research led competitiveness in the development of enzymes, demonstrated in its domain insight, developmental capability, stabilization competence, operational discipline and successful commercialization," Headquartered at Thane (Maharashtra), Fermenta Biotech is a globally oriented, discovery and development driven, biopharmaceutical company operating across a diverse and specialized range of product and service platforms. The company is a subsidiary of DIL (formerly, Duphar Interfran), and was established in 1986 to exploit novel and patented technology related to producing enzymatic products. With 350 employees across different locations in the country and abroad, Fermenta operates in the fields of, vitamin D3 manufacturing, specialist enzymatic biotechnology products, specialist pharmaceutical API's and biotechnology-based solutions to environmental pollution. Effective business model Asked about the utility of the biotechnological applications in enzyme business and his company's role, Mr Verma mentioned, "Fermenta's biotech division comprises two significant product lines namely enzymes and immobilization enzymes (supports on which enzymes are mounted). Fermenta discovers and develops biotechnology solutions derived from a robust domain understanding; the company pioneered the manufacture of Penicillin G Acylase enzyme biocatalyst in India in 1987. Over the years, the company reinforced its position as a cost-effective manufacturer of Penicillin G Acylase biocatalysts for onward application in the manufacture of betalactam intermediates. The company developed and implemented enzymes (FERMASE NA 150, Pencillin G Acylase) for challenging conversion of 6-aminopenicillanic acid (6-APA) into amoxixillin (semi-synthetic penicillin)." Fermenta has tried hard to address the demanding customer needs pertaining to higher product activity, increasing mechanical stability and quality standard. "There was an urgency to shrink the learning curve in this newly developed area on the one hand and scale from grams to kilograms in shortest time," revealed Mr Verma under whom the company responded by developing enzymes on a polymer platform from lab to plant level in 60 days. "One of the shortest such tenures has been achieved through the company's rich domain knowledge in enzyme and immobilization capabilities. The neutralized biological contamination detected by leading contamination experts, made significant manufacturing improvements to reduce contamination and demonstrate superior cleaning methodologies, which reduced contamination and strengthened overall marketing. Apart from that we demonstrated new enzyme properties at the lab, plant and customer levels across the world, strengthening the order book," he added further. Saving the environment! Fermenta's environmental solutions cover three segments including sewage treatment plant, lake and pond remediation as well as oil remediation. The company has developed a bioenzymatic product called Fermsept, to treat organic waste sewage treatment plant, septic tanks and sugar distilleries. Speaking further on that, Mr Verma added, "We have been engaged in various projects for municipal corporations in Nagpur, Pune, Hyderabad, Bellary and Bengalore. Our ultimate aim is to help cleaning the dirty surroundings and help the country go clean and green." Impressive progress During the year 2012-13, the company was successful in commercializing and validating the new product - FERMASE NA 150, a new platform for the enzymatic manufacture of Amoxicillin. "We also demonstrated the new product across different platforms to enhance product visibility. Demonstrated stable technology transfer to customers, which helped to reduce their production cycle time and costs. We also identified new enzyme molecules for cephalosporins," said Mr Verma The company has recorded a turnover of Rs 105 crore during the FY 2012-13. Out of that, about 10 percent constitutes the biotech revenue of the company. In the current fiscal, the company is expecting 20 percent growth in the overall business. "We are expecting close to Rs 200 crore revenue by 2015. And the interesting point is that we expect the share of biotech revenue to go upto 50 percent by then," says Mr Verma. Aiming high! "Keeping in line with the market expectations and in order to consolidate the position of NPGA, new and improved next generation NPGA will be launched. As a strategic extension, new type of enzyme catalyst AEH for application in cephalosporins will be test evaluated. In order to expand our presence in other biotech application moving from antibiotic space, versatile Cal B lipase enzyme will be launched for food and pharma application. In the same lines, other enzymes of high relevance like Phospholipase which are useful in food industry will be developed. Fermenta is a leading innovative company in this area and we want to be a company with global impact," he concludes. ]]> <![CDATA[GE enters into pact with Maharashtra government for upgrading healthcare]]> https://biospectrumindia.com/news/95/8016/ge-enters-into-pact-with-maharashtra-government-for-upgrading-healthcare.html https://biospectrumindia.com/news/95/8016/ge-enters-into-pact-with-maharashtra-government-for-upgrading-healthcare.html Fri, 17 May 2013 17:49:00 +0530 In a consortium which includes the public health department of the government of Maharashtra, Wipro GE Healthcare and Ensocare by Enso Group, a public private partnership project will advance healthcare in the state of Maharashtra for setting up advanced diagnostic facilities at 22 government district and women hospitals. It will operate on a 24/7 hour basis and provide services at government recommended rate cards for the benefit of the broader population. Orange and Yellow 'Below Poverty Line' (BPL) card holders will be entitled to receive free diagnostic services under the Rajiv Gandhi Jeevandayee Arogya Yojana (RGJAY) scheme at all the 22 facilities which are expected to be operational within a year. Speaking on the occasion, Mr Prithviraj Chavan, Chief Minister, Government of Maharashtra said, "Today, we are on to a first-of-its-kind, large scale modernization of district hospitals with latest diagnostic technologies. No single agency can transform the entire healthcare system in the country but by working together with partners like GE and Ensocare, we can take a giant leap in advancing health care to people at all levels in society." The PPP agreement with Government of Maharashtra is the largest in terms of scale and includes the installation of four units of 64 slice CT scanners, 13 units of advance 16 slice CT scanners, eight units of cutting- edge 1.5T Magnetic Resonance Imaging systems, 22 high-end digital radiography systems, 39 color Doppler's and 39 analog X-ray units. These advanced world-class imaging systems will allow district hospitals provide early and accurate diagnosis on a 24/7 basis in the clinical specialty areas of neurology, cardiology, vascular imaging, emergency/trauma, oncology, obstetrics and gynaecology, orthopedics, gastroenterology, in addition to providing general purpose radiology. Also, women's health is given a special boost with the inclusion of 20 screening mammography units for early breast cancer detection. John Rice, vice chairman, GE said, "Providing high quality, accessible and affordable healthcare is one of the biggest challenges faced by governments all over the world. We are delighted to playing our part towards a healthier India and in helping to bridge the healthcare disparity." Commenting on the new partnership, Mr Banmali Agrawala, president and CEO GE South Asia said, "This PPP is the second partnership that we have forged with Maharashtra, the first being GE's setting up of its advanced multi-modal manufacturing plant at Chakan near Pune that we announced last June. This is testament in the progressive development of the state that we believe in the long run will be both economically and socially beneficial to people who live here. We look forward to more partnership opportunities in the future." 38 district and other large hospitals under Government of Maharashtra cater to about 100 million people. It is estimated that in a year, these hospitals carry out 100,000 CT scans, 50,000 MRIs, 300,000 color Doppler studies, 900,000 X-rays and 40,000 mammography exams for early detection and treatment of diseases. In the absence of quality diagnostic imaging equipment, patients are frequently, referred to private centers which substantially increases the cost of treatment. With this, GE Healthcare becomes the first company in India to design a PPP model to deliver quality imaging services comparable to super specialty units in government hospitals. Since the first project with Netaji Subhash Chandra Bose Medical College in Jabalpur in 2007, GE has successfully executed PPP projects spanning four states in India benefitting approximately 500,000 poor and needy patients. ]]> <![CDATA[Vaccine delivery: Unique thermoelectric containers to replace ice packs ]]> https://biospectrumindia.com/news/95/3283/vaccine-delivery-unique-thermoelectric-containers-to-replace-ice-packs-.html https://biospectrumindia.com/news/95/3283/vaccine-delivery-unique-thermoelectric-containers-to-replace-ice-packs-.html Fri, 17 May 2013 11:31:00 +0530 Though the vaccine industry might have grown bigger with time, the product transportation under controlled temperature to the remote areas, still remains a big headache for the manufacturers and public heath workers alike. However, now Hyderabad-based Sathguru Management Consultants' has come up with a solution in form of a portable and battery operated thermoelectric container developed using cutting-edge technologies in collaboration with Dr Rama Venkatasubramanian, director of North Carolina-based RTI International's Center for Solid State Energetics. The thermoelectric container is envisioned to replace the Styrofoam and plastic boxes with ice packs that are currently used to transport vaccines to remote vaccination camps in emerging economies in Asia and Africa. Sathguru's solution to the logistical challenge in last mile of vaccine delivery developed jointly with RTI International has been recognized by Grand Challenges Canada with a grant of CAD 100,000 (Canadian dollars). The program lead from Sathguru, Ms Pushpa Vijayaraghavan believes that this solution bridges a critical gap and infrastructure challenge in vaccine delivery. She notes that while commendable milestones have been achieved in the development of vaccines, their delivery system is still stuck in a rut of age old practices. "Unfortunately, for moving vaccines to the last mile of delivery in remote camps, we still use the Styrofoam boxes and passive cooling technology used 50 years ago. While these ice packed boxes are a cost effective solution, they offer no method to regulate the temperatures in the box and vaccine loss due to temperatures ranging beyond the optimum is a widespread problem. Moreover, the short life of ice packs used significantly limits the length and efficacy of vaccination camps," she says. Ms Vijayaraghavan and Dr Venkatasubramanian believe that their solution will empower health workers with a cost-effective yet new-age thermoelectric solution that can provide active cooling in the WHO mandated temperature range for a period of 24 to 48 hours. While RTI will develop field ready prototypes of the solution, Sathguru will lead the effort in field validation and commercialization of the innovative product. Partners for field validation and commercial production are currently being finalized and will play a critical part in the development of this impactful public health product that could change the landscape of vaccine delivery in resource constrained settings. Sathguru has been recognized among 59 peer-reviewed grantees from low and middle income countries in Round 4 of the Stars in Global Health program for creative, out of the box global health solutions. Grand Challenges Canada is funded by the Government of Canada and is dedicated to supporting bold ideas with big impact in global health. RTI is one of the world's leading research institutes. ]]> <![CDATA[Experts predict 22% growth for pharma industry at Disso India 2013]]> https://biospectrumindia.com/news/95/7929/experts-predict-22-growth-for-pharma-industry-at-disso-india-2013.html https://biospectrumindia.com/news/95/7929/experts-predict-22-growth-for-pharma-industry-at-disso-india-2013.html Thu, 16 May 2013 15:39:54 +0530 India, which exports around US$10 billion worth of pharmaceutical expects 22 percent growth in the current year, industry experts said. "India is the frontrunner in export of pharmaceuticals including formulations and active pharmaceutical ingredients. Sotax India managing director, Dr L Ramaswamy told reporters on the sidelines of a "Disso India 2013". Disso India is a pharma convention that was attended by the professionals from R&D, QA and QC as well as the academia. Around 250-300 delegates had registered and participated in this event, which was said to be the first mega event focussing on dissolution. Since dissolution methods and its application is kept so confidential by each company such events are considered to be important for the industry. The two-day Disso India seminar discussed dissolution methods and its applications as nearly 70 percent of the global pharmaceutical medicines produced under go dissolution testing of tablets and capsules before it gets released. Currently, the export volume of Indian pharma industry to the US is estimated to be $1.2 billion in size. The country has exported US$10 billion plus pharmaceuticals in 2012, which includes 90 percent share of formulations and 10 percent of APIs. More than 180 manufacturing plants are approved by USFDA in India, which is the highest number after the US. "India's share of the generic market is about to 35 percent. Hence the contribution of the Indian pharmaceutical industry for the growth of generic drugs in the world is very high. The pharma industry needs new technology, innovation and needs to sort out various issues faced related to dissolution," said Mr Ramaswamy. Today one tablet out of four consumed in the US or Europe is manufactured by local pharma company. "The Society for Pharmaceutical Dissolution Science (SPDS) is working towards further improving the quality of our production and export thereby try to achieve target of every third tablet consumed in the whole world made in India", he said. Disso India 2013 event also witnessed eminent professionals and global speakers from the pharmaceutical industry. The event was organized under the chairmanship of Dr Vinay G Nayak, the president, technical, Alembic Pharmaceuticals. Dr L Ramaswamy, the managing director of Sotax India is the organizing secretary of this event and the general secretary of SPDS. The scientific sessions were programmed and executed under the chairmanship of Dr Mangal Nagarsenker, HOD and professor of pharmaceutics, Bombay College of Pharmacy, Mumbai. ]]> <![CDATA[MSD launches initiative to decrease pregnant women mortality ]]> https://biospectrumindia.com/news/95/6075/msd-launches-initiative-to-decrease-pregnant-women-mortality-.html https://biospectrumindia.com/news/95/6075/msd-launches-initiative-to-decrease-pregnant-women-mortality-.html Thu, 16 May 2013 15:00:00 +0530 MSD for Mothers has launched its global initiative for helping reduce maternal mortality in India. It has partnered with three leading non-governmental organizations to improve the quality of healthcare that pregnant women in India receive through the private sector. The Hindustan Latex Family Planning Promotion Trust (HLFPPT), Pathfinder International with World Health Partners (Pathfinder), and the White Ribbon Alliance for Safe Motherhood with Gram Vaani (WRA) together will reach nearly 500,000 pregnant women in Uttar Pradesh, Rajasthan, and Jharkhand - areas with some of the highest rates of maternal mortality in the country. The anouncement to this effect was made on May 14, 2013 at New Delhi. MSD for Mothers is a 10-year, US $500 million global initiative launched in 2011 by Merck Sharp and Dohme (MSD), known as Merck in the United States and Canada, to help create a world where no woman dies from complications of pregnancy and childbirth. "We have made great strides towards Millennium Development Goal 5, but we know there's more work to do to reach that target," Mrs Mamta Sharma, chairperson, National Commission for Women said speaking at the India launch. "These new partnerships demonstrate innovative ways of working together to address this issue and bring India closer to our goal." Most care in India is provided by the private sector, which includes a diverse array of independent physicians, nurses, and midwives as well as clinics, hospitals, pharmacies, and health insurers. Additionally, private care is often supported by ambulance services, mobile service providers, and financial institutions. "Maternal mortality is one of the oldest and most preventable health tragedies in the world today. While India has made progress in addressing this, there is still a lot that can be done collectively by the Government, NGOs and the private sector," said Mr Naveen Rao, MD, lead, MSD for Mothers. "Our focus in India is to work with partners who have the capability to improve maternal health care services delivered through the private sector and ultimately decrease the number of women still dying during pregnancy and childbirth." MSD for Mothers and its partners are working to accelerate India's progress towards the United Nations' Millennium Development Goal 5, reducing the global maternal mortality rate by 75 percent by 2015. This goal is not currently on track to be achieved. While India has reduced its rate by approximately 67 percent since 1990, Indian women are still dying during pregnancy and childbirth and there is still a lot that can be done to help prevent maternal mortality. These partnerships will complement the government's initiatives to reduce maternal mortality. Specifically, efforts in India will focus on making private care more affordable by offering private providers standardized tools, protocols, and branding across networks of health facilities; improving quality of care by training doctors, nurses, and health workers and offering women new ways to rate the care they receive; and connecting women in remote areas to doctors and nurses in cities through telecommunication and internet. Talking about the benefits of the launch to India, Mr KG Ananthakrishnan, managing director, MSD India said, "We are proud to have partnered with such prestigious organizations and launch our global MSD for Mothers initiative in India. I believe the project has great potential to benefit our country in helping reduce maternal mortality with a collaborative approach." ]]> <![CDATA[Four innovative technologies get DBT's commercialization award 2013 ]]> https://biospectrumindia.com/news/95/3223/four-innovative-technologies-get-dbts-commercialization-award-2013-.html https://biospectrumindia.com/news/95/3223/four-innovative-technologies-get-dbts-commercialization-award-2013-.html Thu, 16 May 2013 12:46:00 +0530 Among the recepients of biotech product and process development and commercialization awards for 2013 included Dr Samit Kumar Nandi from West Bengal University of Animal and Fishery Sciences for his pioneering work in developing of methods of using biomaterials in treatment of orthopaedic surgical challenges. The awards instituted by the Department of Biotechnology (DBT), Ministry of Science and Technology, were distributed by the President of India, Mr Pranab Mukherjee on May 11, 2013 at a function held in Vigyan Bhawan at New Delhi to mark the National Technology Day 2013. The second receipient was Dr KM Shankar (including other team members Mr Kalkuli Mariappa and Mr Hegde Shankar) from Karnataka Veterinary, Animal and Fisheries Sciences University, Bidar, were awarded for development of farmer level monoclonal antibody-based diagnostics kits for white spot virus of shrimp and other four aquatic pathogens in India. For development parentage verification kits of buffalo, cattle, sheep, goat, camel, yak and mithun, Dr RK Vijh and his team from National Bureau of Animal Genetic Resources (NBAGR), Karnal, were the third recipients of the award. The final award was recieved by Dr Daman Saluja from University of Delhi, who was awarded for his pioneering work for developing PCR-based diagnostic kit for neisseria and chlamydia. ]]> <![CDATA[To tackle counterfeiting, PharmaSecure codes over 50 crore medicines in India]]> https://biospectrumindia.com/news/95/7708/to-tackle-counterfeiting-pharmasecure-codes-over-50-crore-medicines-in-india.html https://biospectrumindia.com/news/95/7708/to-tackle-counterfeiting-pharmasecure-codes-over-50-crore-medicines-in-india.html Wed, 15 May 2013 15:00:00 +0530 The global anti-counterfeit packaging market is expected to be worth US$79.3 billion by 2014, growing at an estimated CAGR of 8.6 percent from 2009-14. At the same time, India as one of the world's leading producers of drugs by volume and increasingly being identified as the drug manufacturing hub for the rest of the world, faces a huge threat by the circulation of spurious medicines being produced by the counterfeit mafia. Therefore, the protection against the fake medicines becomes an important issue in a country like India, where huge number of population suffers from various ailments. Working in this direction, PharmaSecure is the market leader for mobile authentication technology that empowers the end consumer to check and authenticate his own medicine by SMS, voice or web. Each medicine package coded by the company has a unique, randomly generated alphanumeric code printed directly on the package. When a consumer sends this code by SMS (voice or web), a message comes back verifying the medicine is genuine. Within a short span of three years, the company has become the preferred protection partner for over fourteen reputed pharmaceutical manufacturers in India. Today, PharmaSecure solutions have been deployed for manufacturing lines in plants across 35 different geographical locations. The company is known for its accuracy, speed and hassle free integration which has taken the company to newer heights. "PharmaSecure's mobile authentication technology empowers the end consumer to check and authenticate his own medicine at an affordable cost of an SMS, or through pharmaSecure portal/call center," explains Mr Kishore Kar, vice president, sales and marketing. "This service is easy for the consumer and a simple, but effective solution for manufacturers. With increasing mobile use and growing consumer awareness levels, a solution like mobile authentication has huge potential in India and we are very happy to be the pioneers working in this direction of protecting consumers from counterfeit products. PharmaSecure consistently works towards innovating newer technologies/value additions that enhances the way an average Indian consumer looks at his/her medicine. One such initiative in this line was introduction of psConnect last year. This solution offers build-in medicine refill reminders and daily dosage consumption reminders." Mr Kar added, "PharmaSecure through its solutions has opened a channel of communication between consumers and manufacturers. Today, a consumer not only looks at the medicine he/she is consuming but is equally aware of other important aspects including the parent manufacturer." The unique technology of pharmasecure is also being endorsed by several health care practitioners who includes professors and doctors and also from many industry professionals into healthcare. One of the leading orthopedic surgeon from Gurgaon, Dr Ravi Sauhta claims that the service offered by pharmasecure has helped him to offer lot of ways by which he can help his patients to engage in communication to keeps oneself healthy and learns ways to prevent getting trapped to common diseases post-surgery. ]]> <![CDATA[Our vaccines are globally competitive, says S&T Minister ]]> https://biospectrumindia.com/news/95/1229/our-vaccines-are-globally-competitive-says-st-minister-.html https://biospectrumindia.com/news/95/1229/our-vaccines-are-globally-competitive-says-st-minister-.html Wed, 15 May 2013 13:28:00 +0530 "I have been informed that every year about eight million children in the world never make it to their fifth birthday-they are struck down by diseases that we have the means to prevent. Vaccines help prevent killer diseases and are the most cost effective public health products," said Mr Jaipal Reddy, Science and Technology Minister, while addressing the scientists from across in New Delhi on May 14, 2013. Highlighting the strengths of Indian vaccine industry, Reddy mentioned that India is globally competitive and several Indian manufacturers are WHO qualified. "We also produce 60 percent of the worlds vaccine and account for about 70 percent of the annual United Nations vaccine purchases. The current Indian vaccine market is estimated at around $900 million. It targets $4.6 billion revenue by 2017 and poised to grow at 23 percent during 2012-13," the Minister predicted further. Mr Reddy congratulated the Department of Biotechnology (DBT), Program for Appropriate Technology in Health (PATH), Bharat Biotech International Limited (BBIL) and National Institute of Health (NIH) for the successful development of rotavirus vaccine in India. "It gives me great pleasure to be here meeting all of you for this landmark. This has been achieved by close cooperation of Department of Biotechnology, PATH, BBIL and NIH. I have been informed that this project was implemented under Indo-Us Vaccine Action Program, a bilateral program initiated under the Gandhi-Reagan Science and Technology Agreement. I congratulate all the collaborators for this wonderful achievement," the Minister added. "This is an important scientific breakthrough against rotavirus infection, one of the most severe and lethal infections which is responsible for 100,000 deaths of small children in India every year. The clinical results indicate that the vaccine could potentially save thousands of children every year in our country," stated Mr Reddy who also hoped for the successful introduction of this vaccine under the National Immunization Program of Government of India. "I consider this a true model of successful global partnership between India and USA; involvement of international funding agencies like PATH; scientific experts and appropriate industrial partner; and inter-ministerial involvement with active participation of ICMR, Ministry of Health and Family welfare. I am happy to know that ROTAVAC which is developed under this endeavour will be produced on an affordable cost of $1 per dose against the currently available vaccines developed by pharma MNCs which cost $45 per dose," mentioned Mr Reddy further. ]]> <![CDATA[Dr Reddy's grows at 20% to achieve revenues of Rs 116.3 billion]]> https://biospectrumindia.com/news/95/3241/dr-reddys-grows-at-20-to-achieve-revenues-of-rs-116-3-billion.html https://biospectrumindia.com/news/95/3241/dr-reddys-grows-at-20-to-achieve-revenues-of-rs-116-3-billion.html Wed, 15 May 2013 13:19:28 +0530 Dr Reddy's announced consolidated revenues for FY13 at Rs 116.3 billion, recorded year-on-year growth of 20 percent. Excluding the beneficial impact of olanzapine exclusivity in FY12, registered year-on-year growth of 26 percent. The Profit After Tax (PAT) for FY13 was at Rs 17.5 billion and EBITDA was Rs 27.8 billion in FY13. Rs 33.4 billion in Q4 FY13 with a year-on-year growth of 26 percent was the highest ever quarterly performance. During the year, the company launched 78 new generic products, filed 56 new product registrations and filed 47 DMFs globally. During the quarter, the company launched 18 new generic products, filed 14 new product registrations and filed 17 DMFs globally. The biosimilars portfolio grew by 25 percent in FY13 compared to FY12. The revenues from global generics segment for FY13 are at Rs 82.6 billion with a year-on-year growth of 18 percent, primarily driven by North America and emerging markets. Revenues from North America for FY13 at Rs 37.8 billion, recorded year-on-year growth of 19 percent. Excluding the beneficial impact of olanzapine exclusivity in FY12, registered year-on-year growth of 38 percent. Growth was largely driven by key limited competition products such as ziprasidone, fondaparinux, ramp-up in the antibiotics portfolio and products from the Shreveport facility. 14 new products have been launched during the year with major contributors being finasteride 1mg (180 day exclusivity), montelukast granules, atorvastatin, metoprolol, clopidogrel, ibandronate and zoledronic acid 4mg/5mL. The year also saw 19 product filings (18 ANDAs and 1 NDA). Cumulatively, 65 ANDAs are pending for approval with the USFDA of which 38 are Para IVs and 8 have "First To File" status. Revenues from India for FY13 stood at Rs 14.6 billion and recorded year-on-year growth of 13 percent. Revenues from emerging markets for FY13 at Rs 22.4 billion recorded year-on-year growth of 31percent. Revenues from Russia for FY13 stood at Rs 14.0 billion and recorded year-on-year growth of 27 percent, largely driven by volume growth in the major brands and new product launches.During the year, 47 DMFs were filed globally, including 5 in the US and 10 in Europe. The cumulative number of DMF filings as of March 31, 2013 is 577. Income statement highlights: Gross profit margin stood at 52.1 percent in FY13 as compared to 55.1 percent in FY12. Adjusted for the olanzapine exclusivity in FY12, the gross profit margins remained stable. Gross profit margin for global generics and PSAI business segments are at 59.0 percent and 32.5 percent respectively for FY13. Selling, General and Administration (SG&A) expenses including amortization at Rs 33.6 billion increased year-on-year by 16 percent. The increase is primarily on account of regular year-on-year increments in manpower costs, selling costs and the effect of rupee depreciation against multiple currencies. SG&A as a percentage to sales stood at 29 percent in FY13 and compared to previous year there is a fall of 100 bps indicating improved operating leverage. Revenues from Rest of World (RoW) territories at Rs 5.5 billion recorded year-on-year growth of 42 percent. Of this, Venezuela and Australia have shown strong growth in FY13 on the back of higher volumes for existing products and new product launches. Revenues from Pharmaceutical Services and Active Ingredients (PSAI) for FY13 were at Rs 30.7 billion, recorded year-on-year growth of 29 percent. The high growth in pharmaceutical services and API's was on account of increased sales to generic customers on account of patent expirations and higher customer orders in the custom pharmaceutical business. Research and development expenses for FY13 at Rs 7.7 billion is at 6.6 percent of revenues as against Rs 5.9 billion at 6.1 percent of revenues in FY12. During the year, Dr Reddy's benefited by an amount of US$ 22.5 million from one-time settlement done with Nordion (which is formerly MDS). The settlement is towards the damages sustained by the company due to the breach by Nordion of the then existing Laboratory services agreement for bioequivalence studies. Net Finance income in FY13 is at Rs 460 million compared to the net finance income of Rs 160 million in FY12. The change is on account of: Net forex gain of Rs 365 million in FY13 compared to net forex gain of Rs 689 million Net interest expense of Rs 118 million in FY13 compared to net interest expense of Rs 690 million in FY12 Incremental income from mutual funds of Rs 51 million in FY13 over FY12 EBITDA for FY13 is Rs 27.8 billion, 24 percent of revenues and increased by 9.5 percent as compared to the previous year Profit after Tax in FY13 at Rs 17.5 billion, 15 percent of revenues and increased by 17 percent as compared to the previous year Diluted earnings per share in FY 13 are Rs 98.4 Capital expenditure for FY13 is Rs 6.6 billion. ]]> <![CDATA[Indian science and biomedical system are maturing, says DBT chief ]]> https://biospectrumindia.com/news/95/8050/indian-science-and-biomedical-system-are-maturing-says-dbt-chief-.html https://biospectrumindia.com/news/95/8050/indian-science-and-biomedical-system-are-maturing-says-dbt-chief-.html Wed, 15 May 2013 11:26:00 +0530 "This social innovation partnership showcases how Indian science and biomedical system is maturing. We have added to our know-how and capacity in ways that will pay dividends for the development of future solutions," said Dr K VijayRaghvan, secretary, DBT while referring to the success of rotavirus vaccine project. He was speaking at the two-day international symposium on "Rotavirus Vaccines For India- The Evidence And The Promise" that began in New Delhi on May 14, 2013. The two-day long symposium, a joint venture of DBT, Department of Health Research/Indian Council for Medical Research and Indian Academy of Paediatrics discussed the important topic including ROTAVAC - a new rotavirus vaccine; Rotavirus Disease in India; Licensed rotavirus vaccines ; global experience of rotavirus vaccines and recommendations for future efforts. Dr Vijayraghwan highlighted the long and unique road of this vaccine development project - an innovative international model of collaboration across agencies, sectors, continents, and cultures. He said rotavirus is the most severe and lethal cause of childhood diarrhoea and kills around 100,000 Indian children each year and to combat it Indian and international researchers and the public and private sectors joined together to combat a terrible killer and develop this rotavirus vaccine from an Indian strain by an Indian company, and tested by Indian investigators in an effort led by the Indian government. He said our job has been to do the research and development of the innovative solutions and we have had help from global scientists and friends, and the result is a world-class vaccine for India's children and for the first time, we have taken a vaccine from the earliest discovery through every stage of development. Also, this this entire research effort has met strict international standards ethics and quality. And from here, the health ministry will take this forward and make the decision about licensure and introduction. He specially thanked Dr MK Bhan, former secretary of DBT for having a tireless stint in fostering the social innovation partnership and ensuring the highest standards for the vaccine. ]]> <![CDATA[Ranbaxy to pay $500 million in fines]]> https://biospectrumindia.com/news/95/1116/ranbaxy-to-pay-500-million-in-fines.html https://biospectrumindia.com/news/95/1116/ranbaxy-to-pay-500-million-in-fines.html Tue, 14 May 2013 17:44:19 +0530 Ranbaxy has announced that a previously disclosed investigation by the U.S. Department of Justice (DOJ) of data integrity and manufacturing processes at certain Ranbaxy facilities in India has been concluded, with Ranbaxy agreeing to pay $500 million in fines in a settlement with the DOJ. Under the terms of the final settlement agreement, Ranbaxy and its affiliates have agreed to settle alleged civil violations of the False Claims Act with the US all 50 states and the District of Columbia. Separately, a US subsidiary, Ranbaxy USA, has agreed to plead guilty to a criminal information charging violations of the Food, Drug and Cosmetic Act and other criminal statutes. Ranbaxy's payments related to both the civil and criminal settlements total $500 million in aggregate. The financial provision Ranbaxy established in December 2011 will be sufficient to cover all material financial obligations under the agreement. Mr Arun Sawhney, CEO and managing director, Ranbaxy, stated that the conclusion of the DOJ investigation does not materially impact our current financial situation or performance. He added, "Today's announcement marks the resolution of this past issue. While we are disappointed by the conduct of the past that led to this investigation, we strongly believe that settling this matter now is in the best interest of all of Ranbaxy's stakeholders. Ranbaxy has successfully launched several generic products recently and is well-positioned for future growth in the US and around the world with a robust pipeline of important products as it continues to build a strong global portfolio of branded and generic prescription and OTC pharmaceuticals." ]]> <![CDATA[Piramal receives IND approval for antidiabetic molecule from USFDA]]> https://biospectrumindia.com/news/95/8167/piramal-receives-ind-approval-for-antidiabetic-molecule-from-usfda.html https://biospectrumindia.com/news/95/8167/piramal-receives-ind-approval-for-antidiabetic-molecule-from-usfda.html Tue, 14 May 2013 16:38:00 +0530 Piramal Enterprises Limited (PEL) has announced that it has received approval from the USFDA for its Investigational New Drug (IND) P11187. This approval will enable PEL to initiate a phase I clinical trial of P11187 in healthy volunteers in the US. P11187 is an orally active, small molecule New Chemical Entity (NCE), discovered and developed by the NCE Research Division of PEL. P11187 selectively acts on GPR40; a potential therapeutic target for Type 2 Diabetes Mellitus (T2DM). T2DM is an emerging worldwide health crisis with an incidence rate of 300 million by 2025 as predicted by the WHO and accounts for about 90 percent of the diabetic population. P11187 will be tested for safety and its glucose-lowering properties for the first time in humans; both properties having been well-established in our preclinical studies. Currently, the T2DM treatment space has limitations in terms of efficacy and adverse side-effect profiles. The advantage of P11187, as a GPR40 agonist, is the stimulation of insulin secretion in a glucose-dependent manner, thus reducing the potential risk of excess insulin production. Dr Swati Piramal, vice chairperson, Piramal Enterprises said, "The NCE Research division of PEL is dedicated to finding new cures for metabolic disorders. It focuses upon nurturing innovation and break-through thinking to impact the lives of millions of people. P11187's IND approval by the US FDA; recognizes our untiring efforts to identify candidates that would translate into more efficacious drugs for the effective management of diabetes." ]]> <![CDATA[India set to get its indigenous rotavirus vaccine by 2014 ]]> https://biospectrumindia.com/news/95/5095/india-set-to-get-its-indigenous-rotavirus-vaccine-by-2014-.html https://biospectrumindia.com/news/95/5095/india-set-to-get-its-indigenous-rotavirus-vaccine-by-2014-.html Tue, 14 May 2013 15:39:00 +0530 It was a belief that was shown some twenty eight years ago and might have been looked at with lot of skepticism back then. But it was Dr M K Bhan, former secretary of department of biotechnology (DBT) whose dream of manufacturing an indigenous rotavirus vaccine one day kept the efforts multiplying and project expanding. Now, finally the announcement regarding the positive results from a phase III clinical trial of a rotavirus vaccine developed and manufactured in India, were made by the DBT and Bharat Biotech, on May 14, 2013. The data from the trial, presented at the International Symposium on Rotavirus Vaccines for India- The Evidence and the Promise, showed ROTAVAC to have an excellent safety and efficacy profile. The vaccine originated from an attenuated (weakened) strain of rotavirus that was isolated from an Indian child at the All India Institute of Medical Sciences in New Delhi in 1985-86. Since then, partners have included DBT, Bharat Biotech, the US National Institutes of Health (NIH), the US Centers for Disease Control and Prevention (CDC), Stanford University School of Medicine, and the nongovernmental organization, PATH. Dr MK Bhan, who recently completed his service as DBT secretary, was tireless in fostering the social innovation partnership and ensuring the highest standards for the vaccine The clinical study demonstrated for the first time that the India-developed rotavirus vaccine ROTAVAC is efficacious in preventing severe rotavirus diarrhoea in low-resource settings in India. ROTAVAC significantly reduced severe rotavirus diarrhoea by more than half; 56 percent, during the first year of life, with protection continuing into the second year of life. Moreover, the vaccine also showed impact against severe diarrhoea of any cause. "This is an important scientific breakthrough against rotavirus infections, the most severe and lethal cause of childhood diarrhoea, responsible for approximately 1,00,000 deaths of small children in India each year," said DBT Secretary Dr K VijayRaghavan. "The clinical results indicate that the vaccine, if licensed, could save the lives of thousands of children each year in India." ROTAVAC is an oral vaccine and is administered to infants in a three-dose course at the ages of 6, 10, and 14 weeks. It is given alongside routine immunizations in the Universal Immunization Program (UIP) vaccines recommended at these ages.The vaccine was developed through a unique social innovation partnership that brought together the experience and expertise of Indian and international researchers as well as the public and private sectors. The randomized, double-blind, placebo-controlled phase III clinical trial enrolled 6,799 infants in India (aged six to seven weeks at the time of enrolment) at three sites-the Centre for Health Research and Development, Society for Applied Studies (SAS) in New Delhi; Shirdi Sai Baba Rural Hospital, KEM Hospital Research Centre in Vadu, Pune; and Christian Medical College (CMC) in Vellore. Bharat Biotech previously announced a price of US$1.00/dose (or approximately INR 54/dose) for ROTAVAC and will soon file for registration of the vaccine in India. If licensed by the Drugs Controller General of India (DCGI), the vaccine will be a more affordable alternative to the rotavirus vaccines already on the market.Infants enrolled in the study received ROTAVAC and the UIP vaccines, including Oral Polio Vaccine (OPV). When the immune responses to OPV were tested, the result showed that infants receiving OPV at the same time as ROTAVAC generated comparable immune responses to all three polio serotypes as the infants receiving OPV without ROTAVAC; this result supports the concurrent administration of OPV and ROTAVAC. The vaccine development partnership was supported by DBT, the Bill and Melinda Gates Foundation, the Research Council of Norway, and the UK Department for International Development. Bharat Biotech invested important technical, manufacturing, and financial resources towards vaccine development. "ROTAVAC represents the successful research and development of a novel vaccine from the developing world with global standards," said Dr Krishna M Ella, chairman and managing director of Bharat Biotech. "ROTAVAC is a testament of our strong vision and commitment to develop affordable health care solutions for infectious diseases."The support laboratory was the Translational Health Science and Technology Institute with Dr Sudhanshu Vrati as the lead. Quintiles was responsible for several aspects of the trial including medical monitoring, data management, site monitoring, pharmacovigilance, and biostatistics. Good Clinical Practice compliance of the clinical trials was audited by ANTHA Clinical Quality Assurance. ]]> <![CDATA[Novartis announces BioCamp for students]]> https://biospectrumindia.com/news/95/3956/novartis-announces-biocamp-for-students.html https://biospectrumindia.com/news/95/3956/novartis-announces-biocamp-for-students.html Tue, 14 May 2013 12:17:31 +0530 Novartis India announced the next edition of the Novartis Biotechnology Leadership Camp (BioCamp) taking place in Hyderabad from July 8-10, 2013. BioCamp is a pioneering seminar organized by Novartis that brings talented students from diverse faculties and different universities closer to the pharmaceutical industry. Novartis has called for entries from Indian students to represent India at its global Biotechnology Leadership Camp (BioCamp) in Switzerland. BioCamp offers 50 top students the three days hands-on experience with the multifaceted world of pharmaceuticals and direct contact with experts in the field. It aims to bring talented masters, PhD and post-doctoral students from various faculties, closer to the pharmaceutical industry. Three winning students will get to participate in the International Novartis Biotechnology Leadership Camp taking place at Novartis global headquarters from August 25-28, 2013. Mr Ranjit Shahani, vice chairman and managing director, Novartis India says, "BioCamp is a great platform for intelligent, young minds to interact with leaders in the pharmaceutical industry. This three-day seminar provides students the opportunity to look closer at the pharmaceutical industry and helps them make career choices. Healthcare is a challenging area in our country and BioCamp reflects the Novartis commitment to furthering the cause of healthcare." BioCamp is open to post-graduate students and young researchers in natural sciences, medicine, biotechnology, bioinformatics, pharmacy, business administration or law (specialization in intellectual property rights) interested in pursuing a career in the pharmaceutical and biotechnology industry. Interested students should visit the Novartis website for further details. The last date for receiving applications is May 27, 2013. Selected students will have the opportunity to learn from and network with leaders in the pharmaceutical and business sector as well as hone their team building skills. Since launching the BioCamp initiative in 2004, Novartis has introduced more than 500 top graduate students to the biotech industry and entrepreneurship. Besides regional events in various countries, global BioCamps have been held in Taiwan (2004), Singapore (2006), Tokyo (2007), Hong Kong (2008) and Cambridge, Massachusetts (2009) and since then in Basle, Switzerland. ]]> <![CDATA[SRL Diagnostics' drive for innovation]]> https://biospectrumindia.com/news/95/1026/srl-diagnostics-drive-for-innovation.html https://biospectrumindia.com/news/95/1026/srl-diagnostics-drive-for-innovation.html Mon, 13 May 2013 16:44:00 +0530 One of the few diagnostic chains in India that have a dedicated R&D innovation center for developing new diagnostic tests, SRL Ranbaxy focuses on a number of relevant diseases such as tuberculosis, breast cancer, genetic disorders and more. The chain of SRL Diagnostics covers over 4000 diagnostic tests, performing over 50,000 tests per day, through an enviable network managed by more than 2,000 medical and scientific staff, including pathologists, radiologists and scientists. Mr BR Das, head of research and innovation, SRL, says assay development is their strength. "A lot of emphasis is put on quality and we are able to centrally control it through our established validation practices." Mr Das, who is also an India's representative at the Global Association of Molecular Pathology says that the Innovation lab at SRL Ranbaxy has published 54 papers in international journals so far based on research conducted in hepatitis, tuberculosis, HIV, colon cancer, lung cancer and more. The center is also approved by DSIR as an R&D center. Speaking about the tests that are offered for TB diagnosis he says, "We we the first to use Cepheid's GeneExpert for TB diagnosis. We have also indigenously developed a PCR test for the same. Our R&D department also develops markers for different assays, which on being sufficiently validated in clinical trials, are incorporated into our diagnostic tests." In the recent past, SRL Diagnostics has launched 15 gene sequencing based diagnostic tests. Recently an emphasis has been on predictive tests, such as one that is borne out of a collaboration with Asian Heart Institute. The Heart Ensure panel, allows for the detection of certain markers that indicate a susceptibility to cardiovascular disorders. Other advanced fields of testing include neonatal screening , wherein a blood sample is screened for 48 analytes, thus detecting any genetic or metabolic disorders. In addition to being a diagnostic lab it also has facilities for conducting phase II to phase IV clinical Trials. The chain of SRL Diagnostics has 28 labs accredited by the NABL (ISO 15189), three labs accredited by CAP, six labs with ISO 9001:2008 certification from the International Certification Services and one laboratory accredited by the National Accreditation Board for Hospitals and Healthcare Providers (NABH). ]]> <![CDATA[Biovet's pentavalent vaccine wins national award 2013 ]]> https://biospectrumindia.com/news/95/3258/biovets-pentavalent-vaccine-wins-national-award-2013-.html https://biospectrumindia.com/news/95/3258/biovets-pentavalent-vaccine-wins-national-award-2013-.html Mon, 13 May 2013 11:26:00 +0530 The President of India, Mr Pranab Mukherjee on May 11, 2013 presented National Technological Awards held at Vigyan Bhawan in New Delhi to mark the National Technology Day 2013. Among various awards, the national award for 2013 was given to Biovet, Kolar, Karnataka for successful commercial production of blue tongue pentavalent vaccine and Johne's disease vaccine for the first time in India. The technology was provided by Indian Veterinary Research Institute (IVRI) Izatnagar, Uttar Pradesh. On behalf of Biovet, Mr SN Singh, managing director of the company recieved the award along with Dr Tapas Bhattacharya, general manager of the company. Also Dr Gaya Prasad Singh recieved the award on behalf of Indian Veterinary Research Institute, Izatnagar, UP. Instituted by the Technology Development Board (TDB) in 1999, the award carries an amount of Rs 10 lakh and a trophy each to the industrial concern and the technology provider. On this occasion other innovative products supported by Technology Development Board and Council for Scientific and Industrial Research (CSIR) were also launched. The first product which is blood chemistry analyzer and compact portable mobile lab developed by Mr Amit Bhatnagar, an IITian with the assistance of TDB. This analyzer supports the analysis of 23 parameters which includes haemoglobin count, blood glucose, urea, uric acid, creatinine, total protein, bilirubin, cholesterol, triglycerides, SGPT, calcium, magnesium, and phosphorous. Cost of testing all 23 parameters on this device is less than Rs 120 per person. The analyzer is capable of analyzing 4,000 samples during a day. The blood chemistry analyzer costs around Rs 80,000. The second product, hand held integrated battery operated microPCR (Polymerase Chain Reaction) device with real-time detection, has been developed by Bigtec, Bangalore with support from CSIR-NMITLI. This PCR can detect tuberculosis, malaria, dengue, chikungunya, hepatitis B and H1N1, ailments that contribute significantly to the disease burden in India. The device is expected to cost a tenth of a conventional real-time PCR. Mr Pranab Mukherjee and Union Science and Technology Earth Sciences Minister, Mr Jaipal Reddy, who was present on the occasion, also released the Science & Technology Report titled "India: Science and Technology" capturing India's S&T progress over the years emphasising on the nation's objectives to drive innovation at full strength. The report has been published by CSIR and covers subjectson S&T and human resources; innovation support system; S&T and industry; S&T outputs and patents; and rural development and S&T strategies. ]]> <![CDATA[ABLE-AG petitions MoEF, GEAC to allow R&D field trials of biotech-enhanced seeds]]> https://biospectrumindia.com/news/95/3259/able-ag-petitions-moef-geac-to-allow-rd-field-trials-of-biotech-enhanced-seeds.html https://biospectrumindia.com/news/95/3259/able-ag-petitions-moef-geac-to-allow-rd-field-trials-of-biotech-enhanced-seeds.html Mon, 13 May 2013 10:17:00 +0530 The reconstitution of Genetic Engineering Appraisal Committee (GEAC) had led many to believe that the regulatory body would be aggressively taking up the 50 applications for research field trials, pending over a year's time. However, the woes of agri-biotech industry seem to be far from over as there has been no decision yet taken due to absence of few members in the first meeting held on the March 22, 2013 (as per sources). Moreover, the subsequent meeting scheduled for the April was also cancelled without any clear reasons. Therefore, pressed into a difficult situation owing to zero progress since the last 12 months, the the Association of Biotech Led Enterprises - Agriculture Group (ABLE-AG), has expressed apprehensions over the fate of R&D on biotechnology-enhanced seeds, which present potentially vital inputs to enabling food security of the country and farmer prosperity. The industry body that represents major agri-biotech coompanies, has now sought urgent action from the Minister of Environment and Forests (MoEF), Ms Jayanthi Natarajan, and the GEAC to permit research field trials of biotechnology-enhanced seeds in the Kharif season sowing underway for continued R&D efforts by private and public sector institutions. Commenting on the issue, Mr Ram Kaundinya, chairman, ABLE-AG, stated, "It is time to yield to the potential and entrepreneurial spirit of our nations 130 million farmers, science in agriculture talent, and rich diverse natural resources for domestic food, feed, fibre self-sufficiency, farmer prosperity, and to increase India's contribution to helping meets the needs of people in other continents and countries like Africa and China. Farmers choosing biotechnology-enhanced seeds have harvested this potential for the nation in cotton. It is time to yield to the potential of farmers, and technology." "Seed biotechnologies offer benefits for insect protection, weed management, yield enhancement, drought and flood tolerance, nutrition enhancement, healthier oils and more," added Mr Kaundinya who is also the CEO of UPL Advanta Seeds. GEAC, as the apex body in charge of granting field trials permissions for biotechnology-enhanced seeds crops had not met even once between April 2012 and February 2013. This severely affected R&D on biotechnology-enhanced Seeds and has thrown the industry into a tizzy because of the uncertain policy environment due to inaction in the Ministry of Environment and Forests. Dr N Seetharama, executive director, ABLE-AG in letter to MoEF additional secretary Mr Hem Pande, who is also the chairman, GEAC, wrote that the intervening period between the expiry of the term of previous GEAC in April 2012, and the reconstitution of new committee in March 2013 created an unusually long gap; this has resulted in complete halt in conduct of research field trials with biotechnology-enhanced seeds by Indian and international companies, as well as the Indian public sector research institutions. "Let us remember the farmer feeds and clothes our nation. In 2012 field testing of many products had reached a crucial stage in the development, and therefore this delay has created a serious impediment for further progress in product development by most of our member companies. Therefore at least now in Kharif 2013, we need to ensure that field trials are sown in time at the approved sites so that the required biosafety and efficacy data are made available to GEAC to make informed decisions on the safety, efficacy and desirability of these new technologies in the future." He also pointed out that between the 116th and the 117th GEAC meetings, review of more than 50 applications have been pending. "These applications are for different biotechnology-enhanced seeds and traits from public and private sectors, and the outcome has a significant bearing on Indian agriculture, and particularly to the welfare of the farming community," the letter said. Dr Seetharama went on to add that, with the delay in obtaining approvals, the opportunity for planting during 2013 Kharif (from April 15 - July 31, 2013 from North through South India) is now under severe threat of the entire year being lost due to inaction. If immediate action is not taken, it will result in losing yet one more year as the required field trial data cannot be generated without timely planted research field trials. In fact, farmers have already started sowing crops in the irrigated Northern belt (the optimal sowing window in North ends around May 10th each year), and progresses across the country towards the onset of the monsoon. Researchers need to match the planting seasonal window, thus he appealed to the MoEF to give the required approvals immediately. ]]> <![CDATA[Claris Life Sciences slows down on growth path]]> https://biospectrumindia.com/news/95/7388/claris-life-sciences-slows-down-on-growth-path.html https://biospectrumindia.com/news/95/7388/claris-life-sciences-slows-down-on-growth-path.html Fri, 10 May 2013 18:04:18 +0530 Claris Lifesciences announced its unaudited financial results for the quarter ended 31st March, 2013.The consolidated revenues for the quarter stood at Rs. 1,822 million compared to Rs. 1,804 million in the same quarter previous year. The breakup of the revenue between domestic and international sales stood at 40% and 60% respectively. Consolidated earnings before interest, depreciation, taxes and amortization stood at Rs. 541 million for Q1CY13 against Rs. 545 million for the same quarter last year. EBITDA margins stood flat at 30% to net sales. Consolidated Profit after Tax for Q1CY13 stood at Rs. 155 million as compared to Rs. 217 million for the same quarter previous year. The margins have de-grown by 3.5% due to increased depreciation from the IPO capex being put to use this year. During the quarter the company has received approvals for 41 product registrations and has applied for 42 product registrations; out of the 41 approvals 16 have been received in the Regulated Markets, including 2 ANDAs for Ondansetron in the US.During the quarter the company also commercialized 20 product registrations across 13 countries in international markets.The company has finalized and commenced a product development plan for 31 products out of which 20 have been targeted for the regions of US and EU. The FIPB approval for Otsuka and Mitsui's investment in the jint venture was received in March.All other closing conditions of the JV are under process and are said to be on track. Claris hopes to close the deal in July-August, subject to timely regulatory approvals. ]]> <![CDATA[Advanced Enzymes to go for an IPO soon]]> https://biospectrumindia.com/news/95/3242/advanced-enzymes-to-go-for-an-ipo-soon.html https://biospectrumindia.com/news/95/3242/advanced-enzymes-to-go-for-an-ipo-soon.html Fri, 10 May 2013 17:21:00 +0530 One of the leading Indian companies in the Enzymes business, Advanced Enzymes will soon enter the relatively small league of Indian biotech companies that are listed on the stock exchange. In an exclusive chat with BioSpectrum, Mr.Rathi revealed his plans, "We will be going in for an IPO within this financial year. We have already filed the necessary documents with SEBI to be listed on the National Stock Exchange (NSE) as well as the Bombay Stock Exchange (BSE)." Currently Advanced Enzymes manufactures more than 50 different enzymes for different industries such as pharmaceuticals, food, paper, leather and more. The company has declared its revenues for FY 2012-13 as Rs.229.36 crore with exports constituting more than half of the total revenues. Moving ahead, Mr.Rathi said that they would focus on fermentation enzymes. He added, "While we see good growth in enzymes space for the food and feed industry, we also plan to enter the detergent enzyme space soon." Recently Advanced Enzymes completed setting up their fully automatic manufacturing faclilty in Indore. Mr.Rathi proudly says that this was done entirely using internal resources and propreitary knowledge. Though, this led to a few delays, it proved to be a great learning experience for the management. Citing the lack of adequate facilities as one of the major impediments in further expansion, Mr.Rathi suggested that the IPO will prove to be a boon."We will utilize the most funds that are generated for expansion of our existing facilities. Integration of our existing capabilities and expansion are our major goals for the near future." The enzymes market in India is yet to reach its full potential with it contributing to less than 1.5% of the entire global market. Currently in India, a host of mid and large size players operate in the bioindustrial space along with global MNCs. ]]> <![CDATA[Suven Life Sciences secures three product patents in Canada and Eurasia]]> https://biospectrumindia.com/news/95/8271/suven-life-sciences-secures-three-product-patents-in-canada-and-eurasia.html https://biospectrumindia.com/news/95/8271/suven-life-sciences-secures-three-product-patents-in-canada-and-eurasia.html Fri, 10 May 2013 14:27:00 +0530 Suven Life Sciences announced on May 10, 2013, that the grant of two product patents from Canada (2672190 and 2703157) and one (1) product patent from Eurasia (17154) corresponding to the New Chemical Entities (NCEs) for the treatment of disorders associated with Neurodegenerative diseases and these Patents are valid through 2028. The granted claims of the patents include the class of selective 5-HT compounds discovered by Suven and are being developed as therapeutic agents and are useful in the treatment of cognitive impairment associated with neurodegenerative disorders like Alzheimer's disease, Attention deficient hyperactivity disorder (ADHD), Huntington's disease, Parkinson and Schizophrenia. With these new patents, Suven has a total of twelve (12) granted patents from Canada and, thirteen (13) granted product patents from Eurasia. These granted patents are exclusive intellectual property of Suven and are achieved through the internal discovery research efforts. Products out of these inventions may be out-licensed at various phases of clinical development like at Phase-I or Phase-II. "We are very pleased by the grant of these patents to Suven for our pipeline of molecules in CNS arena that are being developed for cognitive disorders with high unmet medical need with huge market potential globally" says Venkat Jasti, CEO of Suven. Suven Life Science is a biopharmaceutical company focused on discovering, developing and commercializing novel pharmaceutical products, which are first in class or best in class CNS therapies through the use of GPCR targets. The Company has twelve (12) internally-discovered therapeutic drug candidates currently in pre-clinical stage of development targeting conditions such as ADHD, dementia, depression, Huntington's disease, Parkinson's disease and obesity in addition to developmental candidate SUVN-502 for Alzheimer's disease and Schizophrenia. Except for historical information, all of the statements, expectations and assumptions, including expectations and assumptions, contained in this news release may be forward-looking statements that involve a number of risks and uncertainties. Although Suven attempts to be accurate in making these forward-looking statements, it is possible that future circumstances might differ from the assumptions on which such statements are based. Other important factors which could cause results to differ materially including outsourcing trends, economic conditions, dependence on collaborative partnership programs, retention of key personnel, technological advances and continued success in growth of sales that may make our products/services offerings less competitive; ]]> <![CDATA['Catalyst for biotech growth']]> https://biospectrumindia.com/features/95/3276/catalyst-for-biotech-growth.html https://biospectrumindia.com/features/95/3276/catalyst-for-biotech-growth.html Fri, 10 May 2013 11:36:00 +0530 On completion of its one year of incorporation on March 20, 2013, the Biotechnology Industry Research Assistance Council's (BIRAC) chose to discuss an approach for addressing national unmet needs and successfully delivering, affordable products through innovation research, industry - academia partnership and strategic global alliances. The overall mood of the participants was upbeat at the three day high level scientific and industrial conclave organized as a part of BIRAC first foundation day celebration at New Delhi. Present at the meeting were 300 scientists, industrialists, policy makers, representative of global philanthropic organizations, start-ups and entrepreneurs. The meet was inaugurated by the minister of science and technology and earth sciences, Mr Sudini Jaipal Reddy. Dr K VijayRaghavan, chairman, BIRAC and secretary, DBT was present alongwith Dr M K Bhan, former secretary, DBT and Ex Chairman BIRAC who advised the BIRAC to break barriers in funding innovations and lend a helping hand to new comers in the industry. Dr Renu Swarup, MD, BIRAC traced the journey of BIRAC and highlighted some key initiative taken during the last one year which include, launch of the Ignition Grant, signing of over 100 public private partnership research agreements, supporting nearly 50 industry academia partnership collaborations and technology acquisition for nutritional crop improvement. Most of the experts agreed that BIRAC should work to bridge the gap among researchers and industry. They pointed out towards the need to evolve better understanding and partnership between Indian Council for Medical Research (ICMR), Department of Biotechnology (DBT) and Indian Council for Agricultural Research (ICAR). It was felt that BIRAC can play a crucial role in laying out a long term concrete vision for meeting the targets set for growth of the sector. Expert advice:What can BIRAC do to strengthen major pillars of biotech? While BIRAC completed its one successful year, the industry leaders, policy makers, prominent academicians and scientists listed out the recommendations for shaping its vision for future. Topic: Science for family health securing maternal and child health in India: Science interventions for improved survival and development Experts: Dr Vinod Paul, Chairperson, Pediatrics Unit, AIIMS; Dr M. K. Bhan, Former Secretary, DBT and Founder Chairman, BIRAC; Mr. Keshav Desiraju, Secretary, Health & Family Welfare; Dr Rajesh Jain, Joint Managing Director, Panacea Biotec Recommendations:â– BIRAC should act as process engine and engage with various disciplinary people like engineers, clinicians, industries and academicians.â– It should play a role in creating transformative tool between industries and regulators. â– It should act as connector between the Demand and Supply organisations of India.â– It should closely work with DBT and Health secretory to put in Human resource training in the area of Indian regulatory system. Through these training workshops "Quality Feedback Mechanism" should be developed. â– BIRAC in collaboration with various Research Agencies, ICMR and industries should form a committee on design of adequate Regulatory systems.â– It should form a Optimization delivery cell for optimising existing technologies to increase its impact at social level. Topic: Addressing agri-biotech challenges and improving food productivity and nutrition Experts: Dr. Vijay Raghavan, Sathguru Management Consultants, Dr Nagarajan, Ex Director General, Indian Council for Agricultural Research (ICAR), Dr K S Charak, Adviser, DBT; Prof. Deepak Pental, Ex-Vice Chancellor, DU; Dr Usha Zehr, Director, Mahyco Research Foundation; Dr Arvind Kapur, CEO, Rasi Seeds Recommendations:â– Accelerate investments in tech. acquisitionâ– Enhance access to proven inventors (not limited by number)â– Energize the translational effort -Rapid weeding, acceleration of candidates, time bound results â– Drive delivery by converging dialogue, investments and rewards Topic Securing maternal and child health in India: research and development in critical disease and development areas: Experts :Dr Harish Iyer, CEO, Shantha Biotechnics; Dr Gagandeep Kang, Christian Medial College Vellore; Dr S Sinha, Adviser, DBT; Dr Shinjini Bhatnagar, Professor, Translational Health Science and Technology Institute (THSTI); Dr Divya Bijlwan, Vice President, Biological E, Dr. Siddharth Ramji, Professor (Pediatrics), Maulana Azad Medical College, New Delhi Recommendations: â– Create an innovation landscape through specially designed science meetings in thematic areas to structure the process of innovation.â– BIRAC newsletter that is widely accessible, publishes relevant literature, dialogues will be trans formative.â– Explore medical, science, engineering and management interdisciplinary networks/collaborations.â– Collaborate with the organizations such as THSTI, Gurgaon to enable creation of platform technologies.â– Support research fellows having mentors from the industry, academia, through scholarships. â– Develop expertise in specific areas like product profiling, market evaluation cost effective analysis, statistical modelling.â– Augment National Regulatory to help evaluate new products, etcâ– Need to evaluate demand for new products in public health Topic: New technologies for improving productivity of Indian crop varieties Experts:Dr Seetharam Annadana, Syngenta; Dr Ajay Parida, Executive Director, MSSRF;Dr J P Khurana, Professor, Department of Plant Molecular Biology, University of Delhi; Dr M Udayakumar, Professor, University of Agricultural Sciences; Dr Paresh Verma, Managing Director, Bioseeds Research India, Dr. Vilas Parkhi, Senior Scientist, Advanta India Recommendations: â– Focus on theme of drought (water relations, cellular tolerance, floral biology, stay green) and radiation use efficiency(photosynthesis efficiency, source to sink)â– There is need to address the gaps between QTL and MAS for drought/abiotic stress. â– A concept of establishing a repository for validated QTL,donor lines and deregulated events has merit.â– Phenotype for drought and radiation use efficiency is a challenge andhence we need state of the art capacity and innovation in phenotyping methodsâ– There is a huge amount sequencing data that is available. Using this,we should invest in comparative genomics and identify genes,allele and markers for key traits.â– Complex traits need projects at idea, proof-of concept, early development and late development.Low hanging fruits must be harnessed to support long gestation projects. Topic: Surveillance, detection and prevention: Keeping India healthy through smart diagnostics and devices Experts: Mr Chandrasekhar B Nair, Director and CEO, Bigtec Labs; Dr Navin Khanna, Group Leader, ICGEB; Dr Alka Sharma, Director, DBT; Dr Om P Manchanda, CEO, Dr Lal Pathlabs; Dr. Nandakumar S, CEO, Perfint Healthcare; Dr Avijit Bansal, SIB Fellow Dr. Sidhant Jena, CEO, Janacare Solutions; Dr Melissa Densmore, Researcher, Microsoft Research India Recommendations: 1) Healthcare:â– Importance of preventive health care in peoples minds â– Increase in % spending on healthcareâ– Health reforms for providing insurance coverageâ– Making accreditation of diagnostic labs compulsory 2) Researchâ– Scaling-up research operations on advanced technologies Optics, Microelectronics, Industrial Design, Nanotechnology, Bimolecular recognition, Materials science, Micromachiningâ– Novel binders for pathogens, Molecular diagnosticâ– Joining company resources and university research to benefit all. Topic: Treatment affordability: Pathways to genomics driven personalized medicine in India Experts: Dr Vijay Chandru, Chairman and CEO, Strand Life Sciences, Dr T. S. Rao, Adviser, DBT, Dr Abraham Kuriakose, Mazumdar-Shaw Cancer Centre, Dr Anand Anandkumar, Chairman & MD, Cellworks Research India; Dr Mallikarjun Sundaram, President & CEO, Mitra Biotech; Dr Binay Panda, Head, Ganit Labs Recommendations: â– Facilitate regulation / IP Issues among various stakeholders â– Should appoint mentors (at different levels, starting from young rolling the sleeve type to experienced senior entrepreneurs) who will work with new/young entrepreneurs from pre-funding to commercialization stage.â– Fund those young/new entrepreneurs who has partnered with proven mentors (no mentor means no funding).â– Should encourage young/new entrepreneurs to incentivize mentors through equity stake in their companies. ]]> <![CDATA[Kemwell Biopharma expands facilities]]> https://biospectrumindia.com/news/95/3277/kemwell-biopharma-expands-facilities.html https://biospectrumindia.com/news/95/3277/kemwell-biopharma-expands-facilities.html Thu, 09 May 2013 17:17:54 +0530 Kemwell Biopharma, a global biopharmaceutical contract development and manufacturing company, has announced that it has expanded its analytical capabilities in India to service an FTE contract for a large multinational pharmaceutical company. Ninad Deshpanday, President of R&D at Kemwell said, "Kemwell has invested in a dedicated facility to meet the needs of this very important customer. The scope of the project includes method transfer, stability sample analyses and analytical method validation for various projects for the customer. We are actively looking to invest in and grow our development business." Kemwell will employ 15 scientists dedicated for this project. Today, Kemwell's R&D division employs more than 100 scientists and provides services ranging from formulation development, analytical development and validation to clinical trial manufacturing. The team has experience working on early stage development programs for NCE's, ANDA's, 505 (b) (2) and product life cycle management projects. The new analytical lab is equipped with 10 HPLC's, one UPLC and nine dissolution apparatus and other major analytical instruments. Kemwell Biopharma is headquartered in Bangalore, and manufactures and develops products for companies, including AstraZeneca, GlaxoSmithKline, Bayer, Novartis, Merck Group, Boehringer Ingelheim and Pfizer. The company employs more than 1000 employees worldwide and has seven production facilities, five in India and two in Sweden. Kemwell is an approved pharmaceutical manufacturer in over 80 countries including the American, European, Japanese and Indian markets. ]]> <![CDATA[Generic drugs on top priority says govt ]]> https://biospectrumindia.com/news/95/3274/generic-drugs-on-top-priority-says-govt-.html https://biospectrumindia.com/news/95/3274/generic-drugs-on-top-priority-says-govt-.html Thu, 09 May 2013 14:51:00 +0530 The minister for health and family welfare, Mr Ghulam Nabi Azad, has stated that the policy of the Government is to promote affordable generic drugs in the country. While making his point in the parliament on May 07, 2013, Mr Azad mentioned that the health ministry has published a National List of Essential Medicines (NLEM), 2011 with the primary objective to promote rational use of medicines considering the three important aspects i.e. cost, safety and efficacy. Furthermore, it promotes prescription by generic names. "The government has also approved the National Pharmaceutical Pricing Policy (NPPP-2012) which brings 348 essential drugs in NLEM 2011 under price control. The Government has also included a new initiative for free supply of essential generic medicines in public health facilities during the 12th plan period," added the minister. With the aim to make available quality generic medicines at affordable prices to all, a country wide campaign in the name of 'Jan Aushadhi Campaign' has been initiated by the Department of Pharmaceuticals in collaboration with the State Governments, by way of opening of Jan Aushadhi Generic Drug Stores in the Government Hospitals and supply of medicines through Central Pharma PSUs. Medicines are provided free of cost to admitted patients in the Central Government hospitals. In OPD of these hospitals, medicines are dispensed free of cost as per the hospital formulary. The government also provides free medicines under the various national health programmes like Anti-Malaria and Anti-TB Programmes. It also provides financial grants to the states under the National Rural Health Mission for procurement of medicines for free supply to the people. States also procure medicines out of their own budget for free supply to the people. ]]> <![CDATA[Indian oncology market to grow 15.46% by 2017 says report ]]> https://biospectrumindia.com/reports-white-papers/95/8284/indian-oncology-market-to-grow-15-46-by-2017-says-report-.html https://biospectrumindia.com/reports-white-papers/95/8284/indian-oncology-market-to-grow-15-46-by-2017-says-report-.html Thu, 09 May 2013 14:13:00 +0530 Cancer cases have been rising at an alarming rate in India. Studies have revealed that incidence of cancer is higher amongst women than men. According to Frost & Sullivan, the Oncology market in India is presently growing at 20 percent year-on-year. Chemotherapy, biologics, targeted therapy, hormonal therapy, and supportive care are the different types of available cancer treatment in India; among which chemotherapy recorded the highest market value of approximately INR 700 Crore in 2012. Oncology market in India is forecasted to grow to INR 3831 Cr by 2017 at a compounded annual growth rate (CAGR) of 15.46 percent. Cancers of oral cavity and lungs in males, and cervix and breast in females, account for over 50 percent of all cancer-related deaths in India at present. In India, there are 28 lakh prevalent cases of all types of cancer, while at least 8 lakh new cases are being witnessed every year. Moving forward, there will be a sharp rise in the market share percentage of biologics and targeted therapy, which are poised to overtake chemotherapy as the preferred treatment option. Discussing the Oncology market in India, Dr Ajaykumar Sharma, Associate Director, Pharma and Lifescience, Healthcare Practice, Frost & Sullivan, says, "Moving forward, Oncology will be a key area of growth in India's healthcare sector. With increase in emphasis on health coverage both by Central and State Governments, spending on coverage of medicines for Oncology will see substantial rise in coming 3-5 years." Among the key challenges currently being faced includes regulatory hurdles, like approvals for Oncology trial procedures. In addition, tight budgets act to further restrict use of new therapies in Oncology. Differential pricing of expensive drugs is another challenge. Also, there is huge shortage of specialized surgical and medical oncologists in India; and there are only 30 Regional Care Centers (RCCs), wherein only 5-6 RCCs employ skilled medical oncologists. Another key challenge is compulsory licensing and patent revocation in India, which has dented the country's image of having a transparent regulatory regime. Instead, the Government should focus more on purchasing expensive drugs, such as ones used for cancer treatment, at tender prices and providing the same at subsidized costs to the population, in order to keep the market forces in equilibrium. Furthermore, less than 15 percent of the Indian population is covered under some form of health insurance, including government-supported schemes while India suffers 20 percent of the global disease burden ratio. Only around 2.2 percent of the population is covered under private health insurance, of which rural health insurance penetration is less than 10 percent. 60 percent of the total health expenditure in India is out-of-pocket expenses borne by the patient. Infrastructure to handle the high incidence of Cancer is still very poor in India. India has close to 1,600 Oncologists (including Medical, Surgical and Radiation Oncologists), thereby creating a huge shortage of Surgical Oncologists followed by Medical Oncologists. There are ~ 30 RCCs (Regional Cancer Centers) of which only 5 to 6 RCCs have adequately trained medical oncologists. ]]> <![CDATA[Lupin posts 35.9% YoY growth in FY 2012-13]]> https://biospectrumindia.com/news/95/3260/lupin-posts-35-9-yoy-growth-in-fy-2012-13.html https://biospectrumindia.com/news/95/3260/lupin-posts-35-9-yoy-growth-in-fy-2012-13.html Wed, 08 May 2013 16:53:00 +0530 Lupin has announced its financial results for FY 2012-13. Net sales grew by 34.7 percent to Rs 25,374 million during Q4 FY 2012-13, up from Rs 18,832 million (Q4 FY 2011-12). During FY 2012-13, Lupin showed a YoY growth of 35.9 percent to Rs 94,616 million up from Rs 69,597 million. Net profits grew by 162.2 percent to Rs 4,081 million during Q4 FY 2012-13, up from Rs 1,556 million (Q4 FY 2011-12). FY 2012-13 YoY growth of 51.5 percent to Rs 13,142 million up from Rs. 8,676 million. The board has proposed a dividend of 200 percent. Additionally, the board of directors approved the appointment of Dr Kamal K Sharma as vice chairman, Ms Vinita Gupta as chief executive officer, and Mr Nilesh Gupta as the managing director. Commenting on the results, Dr Kamal K Sharma, managing director, Lupin Limited, said "We have had a great quarter and a remarkable year fuelled by strong business performance in the US and India as well as improved operational efficiencies. We continue on our high growth journey." The India formulations business contributed 22 percent of the company's overall revenues for the quarter. The segment grew by 43 percent recording net revenues of Rs 5,659 million during Q4 FY 2012-13, as compared to Rs 3,966 million in Q4 FY 2011-12. The Indian market contributed 25 percent of the company's overall revenues for FY 2012-13. The India formulations business grew by 24 percent recording revenues of Rs 23,644 million for FY 2012-13 as compared to Rs 19,058 million for FY 2011-12. Revenue expenditure on R&D for Q4 FY 2012-13 amounted to Rs 1,999 million, 7.9 percent of net sales as against Rs 1,364 million, 7.2 percent to net sales in Q4 FY 2011-12. Revenue expenditure on R&D for FY 2012-13 amounted to Rs 7,098 million, 7.5 percent of net sales as against Rs 5,228 million, 7.5 percent of net sales for FY 2011-12. Lupin filed eight ANDAs and received 10 approvals from the USFDA during the quarter. During the year, the company filed 21 ANDA's and received 14 approvals. Cumulative ANDA filings with the USFDA as of March 31, 2013 stood at 176 with the company having received 78 approvals to date. The company filed three MAAs with European regulatory authorities and has received four approvals during the quarter. Cumulative filings with European authorities now stand at 53 with the company having received 38 approvals to date. Lupin is the 5th largest and fastest growing top five generics player in the US (5.3 percent market share by prescriptions, IMS Health) and the 3rd largest Indian pharmaceutical company by sales. The company is also the fastest growing top 10 generic pharmaceutical players in Japan and South Africa (IMS). ]]> <![CDATA[Jubilant records overall 21% growth, Q4 results decline in profits]]> https://biospectrumindia.com/news/95/5697/jubilant-records-overall-21-growth-q4-results-decline-in-profits.html https://biospectrumindia.com/news/95/5697/jubilant-records-overall-21-growth-q4-results-decline-in-profits.html Wed, 08 May 2013 16:35:00 +0530 The board of Jubilant Life Sciences, an integrated pharmaceutical and life science company met on May 07, 2013, to approve financial results for the quarter and year ended March 31, 2013. As per the statement issued by the company after the meeting, the consolidated profit after tax (PAT), excluding extraordinary items, declined 20.48 percent to Rs 66 crore in Q4 March 2013 over Q4 March 2012. Income from operations rose 18 percent to Rs 1,392 crore in Q4 March 2013 over Q4 March 2012. Earnings before interest, taxation, depreciation and amortization (EBITDA) stood at Rs 244 crore in Q4 March 2013. EBITDA margin stood at 17.5 percent in Q4 March 2013. Jubilant Life Sciences' consolidated (PAT), excluding extraordinary items, rose 5 percent to Rs 382 crore in FY 2013 over FY 2012. Income from operations rose 21 percent to Rs 5,161 crore in FY 2013 over FY 2012. EBITDA grew 18 percent to Rs 1,055 crore year-on-year (YoY) with EBITDA margin at 20.4 percent in FY 2013. For FY2013 income from operations of pharmaceutical segment was Rs 2,658 crore, higher by 22 percent YoY with 52 percent share in the revenue mix. Segment EBITDA was Rs 750 crore, up 30 percent as compared to Rs 578 crore in the previous year. EBITDA margins were high at 28.2 percent as compared to 26.6 percent last year. Pharmaceutical segment comprises of APIs, generics, speciality pharma, CMO, DDDS and healthcare. The life science ingredient segment stood at Rs 702 crore, higher by 13 percent YoY, and contributed 50 percent to the revenue mix. The segment EBITDA stood at Rs 175 crore with EBITDA margins at 24.9 percent compared to 29.7 percent in corresponding period. In FY2013, income from operations of this segment stood at Rs 2,503 crore, higher by 19 percent YoY with 48 percent contribution to overall revenues. Segmental EBITDA was Rs 382 crore, as against Rs 347 crore last year with EBITDA margins at 15.3 percent. Income from life science ingredient operations in Q4 FY2013, was Rs 690 crore, up by 24 percent YoY and contributed 50 percent share to overall revenues. The segment EBITDA was Rs 95 crore, up 95 percent due to better capacity utilization from newly set up plants. The EBITDA margins at 13.8 percent as compared to 8.8 percent last year were up over 500 basis points. Commenting on the company's performance, Mr Shyam S Bhartia, chairman and managing director and Mr Hari S Bhartia, co-chairman and managing director, Jubilant Life Sciences said, "We are pleased to report that the company has delivered strong growth momentum in FY2013 in line with our annual guidance, driven by generic and radiopharmaceutical businesses with new product launches and expansion in geographic outreach. Life Science Ingredients segment has also shown robust growth backed by improved capacity utilization in nutrition and proprietary products." Jubilant Life Sciences said that the company's international revenues accounted for 74 percent of the revenue mix at Rs 3831 crore with regulated markets revenue at an all time high of Rs 3194 crore in FY 2013. Revenue from North America stood at Rs 2132 crore, higher by 27 percent YoY, with a share of 41 percent in the overall revenues, Jubilant Life Sciences said. Revenues from Europe and Japan stood at Rs 1,061 crore, gaining 32 percent with contribution of 21 percent to the revenue mix. Domestic revenues were at Rs 1,330 crore, up 5 percent YoY with 26 percent share to the revenue mix. Revenues from ROW including China stood at Rs 637 crore, up 22 percent with a 12 percent share to the revenue mix, the company said in a statement. With regard to future business outlook, Jubilant Life Sciences said that the growth momentum in the company's revenue and EBITDA is expected to continue and that the outlook remains robust. In the pharmaceuticals segment, the strategy of new product launches and geographic expansion will continue to drive growth while the key driver in the life science ingredients segment will be higher capacity utilisation in the nutrition ingredients and crop science intermediates supported by backward integration of Pyridine. ]]> <![CDATA[Generics and Specialty biz help Glenmark inch closer to USD 1 billion mark]]> https://biospectrumindia.com/news/95/3261/generics-and-specialty-biz-help-glenmark-inch-closer-to-usd-1-billion-mark.html https://biospectrumindia.com/news/95/3261/generics-and-specialty-biz-help-glenmark-inch-closer-to-usd-1-billion-mark.html Wed, 08 May 2013 16:12:00 +0530 Glenmark Pharmaceuticals announced its full year results for the year ended March 31, 2013. Glenmark's consolidated revenue was at Rs 50123.42 million (USD 918.87 million) as against Rsv40206.43 million (USD 828 million), an increase of 24.67 percent in Rupee term. Consolidated net profit of the company for the quarter ended March 31, 2013 was Rs 1667.99 million as compared to Rs 1503.55 million, an increase of 10.9 percent. Net profit for the financial year 12-13 was Rs 6147.43 million as compared to Rs 4603.48 million for the previous corresponding year, recording an increase of 33.5 percent. Mr Glenn Saldanha, chairman and managing director, Glenmark Pharmaceuticals commented, "Both, the Specialty and Generics businesses performed well in FY 12-13; taking our consolidated revenue very close to the USD 1 billion milestone. The US, India and Russia businesses continued to maintain its high growth trajectory. We also made significant progress on the innovation R&D front with five NCE and NBE molecules in clinical trials; including Crofelemer which recently received approval from the US-FDA for HIV associated diarrhea." The India formulations business recorded a growth of 32.39 percent in Q4 and 30.68 percent in FY13. For the fourth quarter ended March 31, 2013, Glenmark's consolidated revenue was at Rs 13354.85 million (USD 245.95 million) as against Rs 10658.56 million (USD 209.63 million) an increase of 25.30 percent in Rupee term over the previous corresponding quarter. Revenue from the generics business was at Rs 5865.32 million (USD 108.04 million), as against Rs 4685.03 million (USD 92.21 million), a growth of 25.19 percent in Rupee term over the previous corresponding quarter. The Specialty formulation business excluding out-licensing revenue was at Rs 7412.94 million (USD 136.48 million) as against Rs 5943.75 million (USD 116.98 million) for the corresponding previous quarter, recording a growth of 24.72 percent in Rupee term over the previous corresponding quarter. The board of directors recommend a final dividend of 200 percent i.e. Rs 2 per equity share of the face value of Re 1 each for FY 2013. Glenmark Generics, US registered revenue from sale of finished dosage formulations of Rs 4291.36 million (USD 79.05 million) for the fourth quarter of FY 13 against revenue of Rs 3434.52 million (USD 67.55 million), an increase of 24.95 % in Rs. term over the corresponding quarter of the previous year. The European generics business posted an increase of 62.38 percent in Rupee term over the corresponding quarter of the previous year. Revenue from sale of API to regulated and semi-regulated markets globally was Rs 938.58 million (USD 17.30 million) for Q4 FY 13 as against Rs 850.05 million (USD 16.69 million) for Q4 of the previous year, recording an increase of 10.41 percent in Rupee term. ]]> <![CDATA[Health share to go upto 1.87% of GDP by 2017 ]]> https://biospectrumindia.com/news/95/3134/health-share-to-go-upto-1-87-of-gdp-by-2017-.html https://biospectrumindia.com/news/95/3134/health-share-to-go-upto-1-87-of-gdp-by-2017-.html Wed, 08 May 2013 12:53:00 +0530 The 12th Five Year Plan (2012-17) outlay for the Ministry of Health and Family Welfare has increased to Rs 30,0018 crore. The Plan envisages substantial expansion and strengthening of the public health systems both in rural and urban areas, with robust provision of primary health care. As per the economic survey 2012-13, the percentage of GDP allocated for health expenditure in the country during 2012-13 (BE) is 1.36 per cent. As per 12th Five Year Plan document, total public funding by the Centre and States, plan and non-plan, on core health is envisaged to increase to 1.87 percent of GDP by the end of the 12th Plan. When viewed in the perspective of the broader health sector, the total government expenditure as a proportion of GDP is envisaged to increase to 3.04 percent by the end of the 12th Plan. The strategy envisaged in the 12th Plan is part of a longer term plan to move towards Universal Health Coverage, which is a process that unfolds over two or three plan periods. ]]> <![CDATA[India no longer on WHO's active polio list ]]> https://biospectrumindia.com/news/95/3249/india-no-longer-on-whos-active-polio-list-.html https://biospectrumindia.com/news/95/3249/india-no-longer-on-whos-active-polio-list-.html Wed, 08 May 2013 11:03:00 +0530 India has been removed from the list of countries with active endemic wild polio virus transmission by the World Health Organization (WHO). Polio free is certified for WHO regions by the Regional Certification Commission and not for individual country. The South-East Asia Regional Commission for Polio Eradication (SEA-RCCPE) has examined the data of 31 states/union territories of India and has accepted the report of the Indian National Certification Committee for Polio Eradication and has concluded that the wild polio virus is not circulating in these states. Each region can consider certification only when all countries in the area demonstrate the absence of wild poliovirus transmission for at least three consecutive years in the presence of certification standard surveillance. In addition, all facilities holding wild poliovirus infectious and potentially infectious materials must have implemented bio-containment measures for laboratory containment of wild poliovirus. Also read: A $5.5 billion six-year plan to get rid of polio globally by 2018 As per the information given by the Minister of State for Health and Family Welfare, Mr Abu Hasem Khan Choudhury, in the parliament on May 07, 2013, "A task force for laboratory containment of wild polioviruses has been constituted. The first phase of laboratory containment started by surveying laboratory to identify laboratory with wild poliovirus, infectious materials or potential wild poliovirus infectious materials and encourage them for destruction of all unneeded materials. All states/UTs have been communicated about the successful interruption of wild poliovirus transmission in India and the possible certification in 2014 and requested for political and administrative support required for completion of laboratory containment activities in their respective states." "Support of WHOs National Polio Surveillance Project (NPSP) is also being obtained to survey all laboratories in their database and provide information of the Laboratories to the Task Force. An inventory of laboratories/Institutes of Department of Bio Technology (DBT) / Department of Science and Technology (DST), Council of Scientific and Industrial Research (CSIR) and Indian Institutes of Technology (IITS)/ National Institute of Information Technology (NIITs), databases of bio-medical laboratories in Department of Health Research (DHR), biotech laboratories in Biotechnology Industry Research Assistance Council (BIRAC) database has been prepared for information on storage of potentially infectious material," added the Minister. ]]> <![CDATA[SPARC's NDA for anti-epileptic drug rejected by USFDA]]> https://biospectrumindia.com/news/95/3178/sparcs-nda-for-anti-epileptic-drug-rejected-by-usfda.html https://biospectrumindia.com/news/95/3178/sparcs-nda-for-anti-epileptic-drug-rejected-by-usfda.html Tue, 07 May 2013 15:49:43 +0530 Sun Pharma Advanced Research Company (SPARC) announced receipt of a complete response letter from the U.S. Food and Drug Administration (FDA) on its New Drug Application (NDA) for Levetiracetam Extended-release Tablets, 1000mg and 1500mg, an anti-epileptic product. A Complete Response Letter is a communication from the FDA to companies that an NDA cannot be approved in its present form. In the Complete Response Letter, the FDA specified that the clinical data submitted by SPARC establishes bioequivalence in the fasted state. However, the FDA has raised certain queries on the Pharmacokinetic data in the fed state. SPARC is evaluating the contents of the letter and plans further discussions with the FDA. Sun Pharma Advanced Research Company is an international pharmaceutical company engaged in research and development of drugs and delivery systems. ]]> <![CDATA[Wellcome Trust awards Â£5 million for neglected diseases research]]> https://biospectrumindia.com/news/95/6218/wellcome-trust-awards-5-million-for-neglected-diseases-research.html https://biospectrumindia.com/news/95/6218/wellcome-trust-awards-5-million-for-neglected-diseases-research.html Tue, 07 May 2013 13:18:00 +0530 The Wellcome Trust has awarded a £5 million seeding drug discovery award to GlaxoSmithKline plc (GSK) to support its open approach to discovering and developing urgently needed new treatments for diseases of low-income countries The funding will help to move early-stage research to find new medicines for diseases such as tuberculosis, malaria, leishmaniasis and sleeping sickness to the next level. Scientists from around the world will work in collaboration with GSK drug discovery experts at the GSK facility in Tres Cantos, Madrid, with the ultimate goal of developing two high-quality experimental drugs over the next five years. Diseases of low-income countries affect millions of people and yet research to find new treatments is struggling, owing to the complexity of the science and low return on investment. To address this, GSK set up its Tres Cantos facility to be an engine room of scientific innovation, stimulating more R&D into diseases that affect the world's poorest people. In 2010, GSK opened the doors of its Tres Cantos facility to external researchers to create the Open Lab. The result is academic scientists working alongside GSK scientists at a dedicated facility, enabling them to benefit from the facilities, resources and knowledge of a major pharmaceutical company to help them advance their own research projects. The £5 million Wellcome Trust funding announced today will be used to take this open approach a significant step further, tackling the next phase of drug development with the aim of turning promising active compounds into high-quality experimental drugs. The funding will provide the opportunity to progress the most promising projects underway by independent scientists at the Open Lab and from GSK's own research portfolio. Dr Nick Cammack, head of GSK's Tres Cantos Medicines Development Campus, which houses the Open Lab, said, "This support highlights a growing recognition that collaborative and open research is the key to tackling these devastating diseases. Since adopting an open approach to discovering new medicines for developing world diseases, we've hosted some of the world's brightest academic scientists at Tres Cantos." He added, "The fusion of their academic excellence with GSK expertise has yielded some really exciting research projects. This tremendous show of support from Wellcome means we now have the potential to start driving these projects further towards finding new medicines." Dr Richard Seabrook, head, business development at the Wellcome Trust, said, "Academic researchers are making incredible progress in our understanding of neglected diseases, yet we've still got a bottleneck when it comes to the development of new drugs. Taking a more collaborative approach, as GSK have through their Open Lab, will see these advances reap the full benefit of the industry's commercial expertise to give us the best chance of securing new treatments for these devastating diseases." ]]> <![CDATA[Venus' innovative 'ELORES' awarded gold medal ]]> https://biospectrumindia.com/news/95/1265/venus-innovative-elores-awarded-gold-medal-.html https://biospectrumindia.com/news/95/1265/venus-innovative-elores-awarded-gold-medal-.html Tue, 07 May 2013 10:55:00 +0530 Venus Remedies, a global pharmaceutical company has been awarded gold medal by DST-Lockheed Martin India Innovation Growth Program - 2013 for ELORES, a drug designed to fight multidrug resistant Extended-Spectrum Beta-Lactamase and Metallo-Beta-Lactamase (ESBL and MBL) producing gram negative Intensive Care Unit (ICU) infections to which other antibiotics failed to respond. The gold medal was received by innovator Dr (Mrs) Manu Chaudhary, director, research, Venus Medicine Research Centre, in an award ceremony held at FICCI office in New Delhi, from Mr Montek Singh Ahluwalia, deputy chairman, Planning Commission of India. More than 1,500 technologies took part in the program this year. Participants were adjudged under various parameters like novelty, innovativeness, technical strength and commercialization potential by a team of experts from Stanford Business School, US, IC2 University of Texas, Austin, US, Lockheed Martin foundation in collaboration with Department of Science and Technology under the Indo-US joint science and technology innovation program 2013. On receiving this award Dr Manu Chaudhary, director, research, Venus Medicine Research Centre said, "Presitigious award from DST-Lockheed Martin Foundation with in the first year of launch of ELORES is a matter of great pride for the team VMRC. Gold medal is a recognition of VMRC's innovations, its credibility and competitive edge in research". She further added that this award has boosted team's determination to take this research product world wide." Globally the systemic antibacterial market is set to reach approx 44 billion by 2016 and is growing with a CAGR of 7.2 percent. Elores is capable of addressing Multidrug resistant ESBL/MBL producing gram negative infections which constitute 25 percent of this market creating an opportunity of more than 11 billion in coming 5 to 6 years. Elores has patent for product, method of treatment and use protected from 45 countries including the US, India, Australia and Europe. Elores was launched in Indian market in early this year and has received tremendous response from medical fraternity. Venus has already filed CTD for this product in Europe, and is planning to take this product to other International markets with the support of Lockheed Martin Foundation, DST, FICCI and all the associated bodies. With its ability to reduce the cost of therapy to patient to >50 percent and offers more than 30 percent faster cure rate besides improving hospital ecology. Elores can become a block buster product in times to come. The India Innovation Growth Program is a joint initiative of the Department of Science and Technology, Government of India; Lockheed Martin Corporation; Indo-US Science and Technology Forum, Federation of Indian Chambers of Commerce and Industry; Stanford Graduate School of Business and the IC2 Institute at the University of Texas. The aim of this program is to accelerate innovative Indian technologies into global markets particularly in the US market. Venus Remedies, headquartered in Panchkula, Haryana (India), is among the 10 leading fixed-dosage injectable manufacturers in the world. The company has three manufacturing units, in Panchkula, Baddi (both India) and Werne (Germany) and 11 overseas marketing offices including a presence in the US and Germany. ]]> <![CDATA["We need a stonger Pharmacovigilance program" says deputy DCGI]]> https://biospectrumindia.com/news/95/2956/we-need-a-stonger-pharmacovigilance-program-says-deputy-dcgi.html https://biospectrumindia.com/news/95/2956/we-need-a-stonger-pharmacovigilance-program-says-deputy-dcgi.html Fri, 03 May 2013 16:26:00 +0530 At the recently organized 3rd Biosimilar Congregation 2013, the challenges involved in the development of biosimilars were brought to center stage, allowing industry professionals, regulators and legal experts to share their views. Dr. V.G Somani, Deputy Drugs Controller India was positive about the scope of biosimilars in India. He said, "India has a good capability in the field of biosimilars as well as a good market, since most innovative molecules are out of reach for the common man. The real challenge in giving approvals for biosimilars is that there is no data from innovator companies available in the country for reference molecules . This makes things very difficult, from a regulatory point of view. Whether we compare it with the actual reference molecule or the Indian reference, things like these present difficulties." When asked what he expects from the drug industry he replied," What we need today is a strong and focused Pharmacovigilance program. This is extremely important from a patient perspective. We are not active about Pharmacovigilance and doctors have been passive about this issue as well. Those you develop a product sould take the onus of gathering information about it as well." One of the leading companies in the biosimilar space has been the biopharmaceutical firm, Reliance Life Sciences. About the market for biosimilars, Bobby George, assitant vice president and head, Regulatory Affairs, Reliance Life Sciences said, "RLS currently has 7 biosimilars in the market with few others in clinical development.Overall. the biosimilar sector has shown a healthy growth. there are approximately 55 players in this market, overall. However there are very few manufacturers in this space, a lot of them import the products." The conferences featured a number of experienced professionals in the biosimilars space, talk about different aspects related to the development and marketing of biosimilars in not just Indian markets but also the US and EU ones. The talk on Indian biosimilar regulations featured Yasmin Shenoy, director, Regulatory Affairs, Sanofi Aventis as well who said, "Even though Sanofi is known worldwide as an innovator company, we are open to biosimilars as well, Shantha Biotechnics is a perfect example of that." ]]> <![CDATA[India, Brazil to pursue joint research in key biotech areas ]]> https://biospectrumindia.com/news/95/1376/india-brazil-to-pursue-joint-research-in-key-biotech-areas-.html https://biospectrumindia.com/news/95/1376/india-brazil-to-pursue-joint-research-in-key-biotech-areas-.html Fri, 03 May 2013 12:59:00 +0530 The Indian Department of Biotechnology, Ministry of Science and Technology and Brazilian Ministry of Science, Technology and Innovation are looking for proposals from the Indian and Brazilian universities, research centres, institutions and industries, to submit joint proposals for scientific and technological R&D translational projects in the area of biotechnology. This call for proposals lies within the "Agreement on Scientific and Technological Cooperation" between the Indian and Brazilian governments, that concluded on March 30, 2012 in New Delhi. The objective is to broaden and deepen cooperation in science and technology in the field of biotechnology; to encourage industrial research and development and related investment flows, bilaterally and or regionally in the field of Biotechnology and to promote transparency through exchange of information and cooperation among relevant institutions. In the area of biotechnology, the research areas given priority in the present call for proposal include biomedicine and health such as diseases like Malaria, Filariasis, Leishmaniasis, and neglected diseases. Among the other areas that will be prioritized include the biotech products such as vaccines, Kits, serum against venom and the scale up processes for biologics. The agriculture especially sugarcane and citrus and bioenergy too will be given due attention. The duration of each project will be three years (36 months). The principal investigators from universities and research institutions of each side who fulfill national eligibility rules for research grant application are eligible to apply. Both from Indian as well as Brazilian side, the researchers from the private industry may participate in the joint collaboration only as member of the project having principal investigator from the academia. The last date for sending the proposals in July 22, 2013. ]]> <![CDATA[Intas Pharma launches Rituximab biosimilar]]> https://biospectrumindia.com/news/95/6000/intas-pharma-launches-rituximab-biosimilar.html https://biospectrumindia.com/news/95/6000/intas-pharma-launches-rituximab-biosimilar.html Thu, 02 May 2013 17:05:41 +0530 Intas Pharmaceuticals has launched "Mabtas",a biosimilar version of Rituximab, with a view to make Non-Hodgkin's Lymphoma (NHL) treatment cost-effective . Mabtas is competent in treating diseases characterized by excessive numbers of B cells, overactive B cells, or dysfunctional B cells like Chronic Lymphocytic Leukemia (CLL) and Rheumatoid Arthritis apart from NHL. Mabtas is Asia's only EU GMP facility of Intas Biopharmaceuticalsa at Ahmedabad. With the launch of this product, Intas now is the only company to have indigenously developed 6 biosimilars in the domestic market. Intas Biopharmaceuticals is India's first and only biopharmaceutical companies to receive European Union - Good Manufacturing Practice (EU-GMP) certification for its microbial manufacturing facility and only company having product under-registration with EMA. Intas Biopharmaceuticals is already a leading manufacturer of Erythropoietin, G-CSF and peg G-CSF for India and have introduced world's first biosimilar peg G-CSF. Mabtas marks the first monoclonal antibody (mAb) launch from Intas. With this product Intas joins the ranks of select few Indian companies to launch a mAb product in the domestic market. ]]> <![CDATA[Govt claims Malaria deaths on decline, independent reports suggest otherwise ]]> https://biospectrumindia.com/news/95/1300/govt-claims-malaria-deaths-on-decline-independent-reports-suggest-otherwise-.html https://biospectrumindia.com/news/95/1300/govt-claims-malaria-deaths-on-decline-independent-reports-suggest-otherwise-.html Thu, 02 May 2013 11:45:00 +0530 As per the health ministry of India, the number of reported deaths due to malaria is declining. If the ministry's statistcs were to be believed, from 1,055 deaths in the year 2008, approximately 506 (provisional) death cases have been reported in 2012. In between there were 1,144 deaths in 2009, 1,018 death cases in the year 2010, and about 754 deaths in the year 2011 across India. "The intensified prevention and control efforts have resulted in the decline of reported malaria deaths in the last five years," stated the minister for health and family welfare, Ghulam Nabi Azad on on April 30, 2013, in the Parliament. However, there are global reports that prove the goverment claims wrong. While the government has said maintained that only 1,018 Indians died of malaria infection in 2010, A Lancet study published in 2011, on the other hand, said malaria actually killed an estimated 46,800 Indians in 2010. According to the World Malaria Report 2011, over 70% of India's population face the risk of malaria infection. Around 31 crore people face the "highest risk" of getting infected. India has over 10 crore suspected malaria cases but only 15.9 lakh could be confirmed in 2010. Infact, the media reports in past have suggested that the government was looking at revising its own figures which seemed to be 20 times lesser than the actual.A commintee appointed by the Indian Council Medical Research (ICMR) had reported that there the deaths are 40 times more than what figures in government's statistics. ]]> <![CDATA[Nova Medical Centers brings Renaissance Surgical Robot to India]]> https://biospectrumindia.com/news/95/3238/nova-medical-centers-brings-renaissance-surgical-robot-to-india.html https://biospectrumindia.com/news/95/3238/nova-medical-centers-brings-renaissance-surgical-robot-to-india.html Wed, 01 May 2013 17:45:00 +0530 Mazor Robotics, a developer of innovative surgical robots and complementary products, on May 01, 2013 announced that Nova Medical Centers, a leading short-stay surgical chain in India has placed an order for a RenaissanceTMsurgical robot system through Advanced Medical Systems, Mazor's distribution partner in India. The system will be used at the Nova Orthopaedic & Spine Hospital, a newly-opened state of the art hospital in New Delhi, dedicated to orthopaedic and spinal surgeries.This system marks the second Renaissance system in India. In 2009 Nova pioneered the concept of multispecialty Short-Stay Surgery Centers in India to address the need for world class healthcare that is affordable and accessible. Nova's objective has been to eliminate unnecessary hospitalization and hospital induced infections, leading to superior medical outcomes and delivering the highest level of patient satisfaction. Nova is now at the forefront of providing best in class surgical care, with 12 multispecialty short-stay surgical centers across India. Nova has begun its second phase of expansion by creating surgical facilities for dedicated specialties. The Nova Orthopaedic & Spine Hospital is designed to be India's leading specialty hospital devoted to the full range of orthopaedic and spine surgical care. "This system sale represents Mazor's second installment in India, but given the high efficacy of Mazor's RenaissanceTM system and a desire by hospitals to provide its patients with the best procedural outcomes, I believe we are just at the beginning of what could be a much larger installed base," commented RomeshKaul, President and Chief Executive Officer of AMS." Dr. Harsha Hedge, Medical Director (Orthopaedics) at Nova and one of India's most-renowned and experienced orthopedic surgeons, will be using the robotic system. With his vast training and experience in addition to his stellar reputation, there is no better ambassador for letting the whole of India know about the benefits of using Mazor's RenaissanceTM system."Dr. Harsha Hegde has a rich experience of more than 20 years in the field of Joint replacements, Arthroplasty and Spinal surgeries. He has not only gained expertise throughhis training at premier institutions, but also by treating thousands of patients every year. He has done more than 4000 joint replacement surgeries and around 2500 spine surgeries in the last ten years. Dr Harsha is considered as one of the top orthopaedic and spine surgeons in the world today. DrHegde, Director Medical Services at Nova Orthopaedic & Spine Hospital stated "The Hospital has been custom created for providing world-class Orthopaedic care and rehabilitation. We believe that "Movement is Life" and our efforts are directed towards preserving and enhancing the patient's quality of life." "Nova Medical Centers is one of India's leading healthcare providers, working in partnership with doctors to ensure patients come first and that the most advanced services and technologies are employed for better patient outcomes" stated OriHadomi, Mazor's CEO. "By selecting to use our RenaissanceTM system, Nova is maintaining this commitment and we are confident that our relationship with them will only strengthen going forward. Additionally, we are especially pleased to have a wonderful distribution partner in AMS - together we will continue to identify new opportunities to advance our business objectives." Renaissance, Mazor Robotics' next generation surgical guidance system for spine procedures, is transforming spine surgery from freehand operations to highly-accurate, state-of-the-art procedures, with less radiation - even for minimally invasive surgery, scoliosis, and other complex spinal deformity cases. It is the only robotic technology for spine surgery available in the marketplace. ]]> <![CDATA[Will eliminate Kala-azar by 2015 says govt ]]> https://biospectrumindia.com/news/95/3237/will-eliminate-kala-azar-by-2015-says-govt-.html https://biospectrumindia.com/news/95/3237/will-eliminate-kala-azar-by-2015-says-govt-.html Wed, 01 May 2013 16:52:00 +0530 Kala-azar is a slow progressing indigenous disease caused by a protozoan parasite of genus Leishmania. As per the comparative data between 1992 and 2003, available from National Vector Control Programme, there has been 76.38% decline in incidence and 85.20% in deaths caused by the disease. National Health Policy, 2002 envisaged the target to eliminate Kala-azar by 2010 i.e. less than 1 case per 10,000 population at sub-district level, which could not be achieved. Now the revised target for elimination of Kala-azar as per union minister health minister Ghulam Nabi Azad, is 2015. Speaking in the Parliament on April 30, 2013, Mr Azad mentioned, "Kala-azar is a vector borne disease and its elimination from the community depends on various environmental, socio-economic and health systems related factors. The treatment procedure for the disease has been shifted from injectable to oral drug as first line of treatment to improve the treatment compliance." "Miltefosine capsule has been introduced for both adult and children as 1st line treatment. The 2nd line treatment is Amphotericin B injection being used for pregnant women/child bearing age women and also for children less than one year age," added the minister further. ]]> <![CDATA[Syngenta, NRCG research partnership to benefit grape farmers]]> https://biospectrumindia.com/news/95/3236/syngenta-nrcg-research-partnership-to-benefit-grape-farmers.html https://biospectrumindia.com/news/95/3236/syngenta-nrcg-research-partnership-to-benefit-grape-farmers.html Wed, 01 May 2013 13:16:00 +0530 The research was done using different crop protection brands of Syngenta India Limited, to ensure production of quality grapes with a lower MRL that can meet the stringent requirements of the European market. This is crucial at a time when Maharashtra grapes are registering an impressive footprint across EU. The results gain importance when Maharashtra has recorded a remarkable 26 K tonnes of grapes export this year so far as against 15 K tonnes in March last year. Majority of the exports are done to European Union countries, which impose stiff quality control regulations including minimum residues levels (MRL). The research report of Syngenta India Ltd and NRCG, which is ready for publication in academic journals, noted that "Plant protection practices in vineyards based on location specific weather forecast and guideline developed by NRCG, Pune are useful in reducing expenses on crop protection and produce quality grapes with less pesticide applications and residues,". It further adds: "The schedule developed by NRC for Grapes Pune and Syngenta India Limited using mainly Syngenta brands, when implemented, based on location specific weather forecast and above mentioned guidelines, showed effective disease and insect pest management in grapes. Thus the pesticide schedule can be adopted by growers along with weather forecast based advisory developed by NRC for grapes, Pune. The usage of pesticides however, will be based on valid CIB label claims of the formulations for use in grapes." NRCG is a nodal Indian Council for Agricultural Research (ICAR) institute responsible for research and development in grapes. The institute and its scientists are well known for their technical knowledge and expertise in different aspects of grape cultivation. "Grape farmers suffer losses when a consignment is rejected due to MRL issues. Syngenta decided to solve this problem proactively and launched this research project with NRCG and results speak for themselves. This will help growers minimize their rejections and increase their returns. In addition growers achieve sustained profits and protect the environment. For Syngenta this is living its value and purpose of bringing plant potential to life," said Syngenta representative Mr Gudihal Anand, Head, Crop Marketing, Specialty crops, South Asia. Grape is one of the important fruit crops grown in India. It offers attractive remuneration to growers due to domestic demand and export to European countries. Insect pests and diseases are some of the major hurdles in improving productivity. Regular usage of crop protection products is one of the important considerations in grape cultivation but most of the times the grower's anxiety results in indiscriminate use leading to residues beyond acceptable limits. This results in rejection of export consignment and huge losses to the grower. The findings of the research are significant as they will help growers across the country follow robust and scientific crop protection processes, reduce expenses and help them grow world-quality grapes. Though Maharashtra accounts for the largest share of grape cultivation - 82% - of 220,000 tonnes, according to Agricultural and Processed Food Products Export Development Authority (APEDA), grapes are also cultivated in other states including Karnataka, Tamil Nadu, Andhra Pradesh, Mizoram, Punjab, J&K, Haryana, Rajasthan and Himachal Pradesh. Growers are a happy lot. Mr Pramod Rao Saheb Patil of Bolwad in Sangli district said, "Because of changing climatic conditions the use of quality crop protection products like those from Syngenta are the need of the hour. It is because of Syngenta fungicides Revus & Amistar that my vineyard is safe even though weather conditions were favorable for the deadly disease - downy mildew. All growers should use Syngenta's new generation fungicides like Revus and Amistar to produce disease free and quality raisin." One of the key factors in grapes productivity is the spraying decision, which for want of scientific know-how and extension, has been a handicap. Now with the new research, it is proved that when spraying decision is taken based on weather conditions and scientific forecasting it helps to reduce the number of sprays and production of high-quality grapes. The study found that growers could save upto 9 sprays per season using Syngenta's schedule, which constitutes about 33% saving on their expenses. Helping growers has been a focus for Syngenta. "Revus 25 SC is the best front line fungicide for effective management of Downy Mildew. Amistar 25 SC is the best solution for the management of both Downy and Powdery mildew. It helps in increasing the quality aspects and helps to reduce Pink Berry incidence. Residues of the recommended pesticides were found lower than MRL prescribed by EU countries," informed Dr Deshmukh on the products of Syngenta. ]]> <![CDATA[A $5.5 billion six year plan to get rid of polio globally by 2018]]> https://biospectrumindia.com/news/95/3005/a-5-5-billion-six-year-plan-to-get-rid-of-polio-globally-by-2018.html https://biospectrumindia.com/news/95/3005/a-5-5-billion-six-year-plan-to-get-rid-of-polio-globally-by-2018.html Wed, 01 May 2013 12:41:00 +0530 Experts at the 'Global vaccination Summit' predicted that by the end of 2018, the world could be free from Polio with a robust $5.5 billion vaccination and a monitoring plan. This is the first 6 year plan made to eradicate all types of polio disease (both wild poliovirus and vaccine derived cases) simultaneously. At the Summit, commitments and pledges helped USD 4 billion of the $5.5 billion needed to implement the six year plan. The plan incorporates the lessons learned from India's success becoming 'polio free' in early 2012 and cutting-edge knowledge about the risk of circulating vaccine derived polioviruses. India is being commended as the nation that could help guide the three endemic nations - Pakistan, Afghanistan and Nigeria - to attaining similar success through their experience. The country is en route to completing three years without a case of Polio that makes it eligible for the regional Polio-free certification in 2014. The total $5.5 billion six year budget requires sustaining current yearly spending to eradicate polio. It also includes the costs of reaching and vaccinating more than 250 million children multiple times every year, monitoring and surveillance in more than 70 countries, and securing the infrastructure that can benefit other health and development programs. "After millennia battling polio, this plan puts us within sight of the endgame. We have new knowledge about the polioviruses, new technologies and new tactics to reach the most vulnerable communities. The extensive experience, infrastructure and knowledge gained from ending polio can help us reach all children and all communities with essential health services," said Ms. Margaret Chan, World Health Organization (WHO) Director-General. Rotary International, the flagship donor to the GPEI, pledged its commitment through 2018 to raise funds and mobilize support of the endgame strategy. "India is a live example of success. Uttar Pradesh has already been announced as Polio free and we are hopeful that finally we will be able to defeat Polio by February 2014 with continuous efforts and enough fund commitments backing the initiative", said Mr. Deepak Kapur who is Chairman Rotary International's India Polio Committee and for the past more than a decade leading a volunteer team of Rotarians committed to making India Polio-free. Supporting the plan, various philanthropists from all across the world endorsed the value of investing in the end of polio. At the summit, Bill Gates announced that his foundation would commit one-third of the total cost of the GPEI's budget over the plan's six-year implementation, for a total of $1.8 billion. Other philanthropists present at the summit pledged contributions amounting to an additional US$335 million toward the plan's six-year budget. Public health experts say if the polio eradication campaign succeeds, the world would not only declare its second eradicated disease - smallpox was wiped out in 1979 - it would also be billions of dollars richer. A 2010 analysis found that if polio transmission were to be stopped by 2015 the net benefit from reduced treatment costs and productivity gains would be $40 billion to $50 billion by 2035. ]]> <![CDATA[10 Indian ideas get a $100,000 boost]]> https://biospectrumindia.com/news/95/6988/10-indian-ideas-get-a-100000-boost.html https://biospectrumindia.com/news/95/6988/10-indian-ideas-get-a-100000-boost.html Tue, 30 Apr 2013 18:03:00 +0530 Grand Challenges Canada yesterday, announced the 102 bold global health ideas that have won the $100,000 grant prize. Apart form the 43 ideas that were from Canada, 59 were from low and middle income countries from Africa, Asia , Latin America and the Middle East. If their ideas prove effective, the innovators will be eligible for an additional Grand Challenges Canada scale-up funding of up to $1 million.The fact that a majority of the ideas, originating from India revolve around the country's major healthcare concerns, diseases such as diabetes and tuberculosis is indeed very apt. Three of the ideas are centered about the diagnosis of tuberculosis.Niraj Sanghai from Sinhagad Technical Education Society won the grant for the optimization and validation of a point-of-care diagnostic test for tuberculosis, while Devang Patel from Ahmedabad based GIOSTAR Research's idea to develop a novel single assay that can diagnose active, latent and drug-resistant tuberculosis made the cut for the peer reviewed judging process. Ruchika Raghuvanshi, Vikrant Education Socity is the Principal Investigator on the project for the development of ta immunodiagnostic assay for lipid antigen detection of pulmonary and extra pulmonary tuberculosis that also won a grant. In a telephonic conversation with BioSpectrum she said, "The diagnostic test that we have developed, with my mentor Dr. Bisen, is more accurate than the ones currently in the market, since they involve monoclonal antibodies that are highly specific. We will utilize the grant money to carry out further trials and towards commercialization efforts." Considering the rapid reach that mobile communications has achieved in recent years, innovators everywhere are creating solutions for tapping into this network for addressing healthcare issues.While DXPhone is a mobile phone platform for glucose monitoring by Sidhant Jena from Janacare Solutions, Vivek Vajaratkar from INFORM is creating a mHealth platform that will improve functional outcomes for children with neuro developmental disabilities with the aid of the network of community health workers in India Ms.Raghuvanshi added, "The test will be extremely affordable, and made available at Rs.4/sample." Dr. Peter A. Singer, CEO of Grand Challenges Canada said, "Canada's commitment to bold ideas with big impact is captured in each of these more than 100 peer-reviewed projects. By matching talent with opportunity, Grand Challenges Canada is contributing to saving and improving lives." Past awardees include Bangalore based Achira Labs, that was given the grant for developing a point of care diagnostic by weaving it into a piece of silk, using the principles of microfluidics and Bigtec Labs for a mini PCR, which was launched recently that can detect infectoius diseases in an affordable and timely manner. Other innovative ideas include a project, led by Kumari Smita from Battelle Science and Technology India on developing Plant-based high-intensity protein sweeteners as a means to alleviate the growing epidemic of diabetes. Another important health intervention for highly prevalent condition of anaemia is ToucHb, developed by a group of IIT graduates with medical professionals. ToucHb is a hand held device for that provides a needle free screening mechanism for anaemia in remote areas. An important innovation in the field of vaccines is a battery operated thermo-electric container, NanoCool by project lead, Pushpagiri Vijayaraghavan from Sathguru Management Consultants, that can address the serious problem of wastage of vaccines due to lack of efficient cold storage facilities. Lastly, Sanjoe Jose from Emprenure Labs won the grant M-Ultra, a low-cost ultrasound scan system that can act as a point-of-care diagnostic tool aiding early diagnosis ]]> <![CDATA[WNS extends contract with GSK for research and analytics services]]> https://biospectrumindia.com/news/95/3239/wns-extends-contract-with-gsk-for-research-and-analytics-services.html https://biospectrumindia.com/news/95/3239/wns-extends-contract-with-gsk-for-research-and-analytics-services.html Tue, 30 Apr 2013 16:21:27 +0530 WNS (Holdings), a provider of global Business Process Outsourcing (BPO) services, announced that it has extended its contract with global pharmaceutical leader GlaxoSmithKline Services Unlimited (GSK), to deliver high-end research and analytics services. "In a rapidly changing and increasingly competitive global economy, the ability to analyze large amounts of complex data to drive insight-based decisions is critical to success. WNS has been a trusted partner in delivering these high-value analytics solutions to GSK, and we are delighted to announce this contract extension with a recognized leader in the pharmaceutical industry," said Keshav R. Murugesh, Group CEO, WNS Global Services. WNS enables its global clients to make critical business decisions leveraging its research and analytics expertise, deep industry knowledge and robust delivery capabilities. WNS currently has over 2,000 research and analytics professionals supporting areas such as customer lifecycle analytics, market and business research, strategy and decision support, demand forecasting, customer risk scoring, loss management modeling, and measurement and reporting. ]]> <![CDATA[Government to intensify efforts on child vaccination ]]> https://biospectrumindia.com/news/95/1039/government-to-intensify-efforts-on-child-vaccination-.html https://biospectrumindia.com/news/95/1039/government-to-intensify-efforts-on-child-vaccination-.html Mon, 29 Apr 2013 16:46:00 +0530 The communication campaign aimed at increasing awareness among people in remote areas, was launched by Ms Anuradha Gupta, Additional Secretary, Ministry of Health and Family Welfare and Mission Director, National Rural Health Mission on April 29, 2013 at New Delhi. The media event was held in presence of development partners and health officials, in collaboration with UNICEF, as a part of the first special immunization week (April 24-30). Speaking to media, Ms Gupta mentioned that the special immunization week is an opportunity to reinforce India's call to action for child survival and development. "The new RI logo and other communication material will promote consistent messaging to raise awareness on the urgency of reaching every child with lifesaving immunization," added Anuradha Gupta while pointing towards a new RI logo, TV spot, radio spot and posters that have been included in the campaign. She also emphasized on the need of ensuring that all the vaccines given free of cost, reach every last child in the country. Emphasizing on UNICEF's focus to promote equity in programme results, Mr Louis Georges Arsenault, UNICEF India Representative said, "In India, inequity persists within and between states. There are geographical, rural-urban, rich-poor, gender and other related differences in vaccination coverage. Disparities need to be addressed to reach every last child. The Special Immunization Week is an opportunity for all of us to renew focus on ensuring equity in immunization coverage." "Pentavalent vaccine expansion is a significant step in India's call to action to renew its commitment to child survival and development by strengthening key strategic public health interventions. Pentavalent protects children from Hib pneumonia and Hib meningtisin addition to protection from diphtheria, pertussis, tetanus and Hepatitis B," said Mr Rakesh Kumar, Joint Secretary, Ministry of Health and Family Welfare. The intensified campaign comes in backdrop of the fact that close to 75 lakh children every year miss the benefits of childhood vaccinations. A majority of those missing the opportunity are from among the undeserved and marginalized populations. Being unvaccinated keeps them at highest risk of catching life threatening childhood diseases. Keeping in view these facts, the year 2012-13 was declared as "Year of Intensification of Routine Immunization" by the government of India. After successful introduction in Tamil Nadu and Kerala, intensification efforts saw the expansion of pentavalent vaccine to six more states in India. ]]> <![CDATA[No stem cell project in India to address sickle cell anaemia]]> https://biospectrumindia.com/news/95/6539/no-stem-cell-project-in-india-to-address-sickle-cell-anaemia.html https://biospectrumindia.com/news/95/6539/no-stem-cell-project-in-india-to-address-sickle-cell-anaemia.html Mon, 29 Apr 2013 16:11:47 +0530 Sickle cell anemia is the most common form of sickle cell disease (SCD). A national multicentric study carried out on behalf of Indian Council of Medical Research (ICMR) in the last decade indicated that the sickle cell gene was present in all the tribal groups and the gene frequency varied from 0.005 to 0.110. Recently, on being asked about the country's initiatives for addressing this situation, Minister for Health and Family Welfare, Ghulam Nabi Azad mentioned that according to ICMR, currently no stem cell research project has been undertaken to control sickle cell anaemia. Also there is no proposal to set up institute or hospital for the purpose of stem cell research to control sickle cell anaemia. This disease is largely but not exclusively restricted to tribal groups. Sickle Cell Disease is prevalent throughout Central India starting from Gujarat and Maharashtra in the West and through Chhattisgarh, Madhya Pradesh and Jharkhand upto the Eastern State of Odisha.Though there is no sure-shot cure for the disease bone marrow transplant of stem cell transplants are the most popular methods used. In SCD, the body makes sickle-shaped red blood cells instead of normal disc shaped erythrocytes and contain abnormal hemoglobin called sickle hemoglobin or hemoglobin S. This sickle hemoglobin causes the cells to stick to each other and eventually tend to block blood flow in the blood vessels of the limbs and organs which can lead to pain and organ damage. The Sickle Cell Society of India, Nagpur has sent a representation regarding setting up of Molecular Genetic Laboratories in the tribal areas where the prevalence of sickle cell anaemia is higher. The Rashtriya Bal Swasthya Karyakrama (RBSK) recently launched under NRHM, provides for early detection and treatment of sickle cell anaemia among children. State governments can submit proposals for treatment of sickle cell anaemia cases in their respective Programme Implementation Plans (PIPs) for consideration of central assistance under NRHM. ]]> <![CDATA[Granules India posts 17 percent rise in net sales]]> https://biospectrumindia.com/news/95/6254/granules-india-posts-17-percent-rise-in-net-sales.html https://biospectrumindia.com/news/95/6254/granules-india-posts-17-percent-rise-in-net-sales.html Fri, 26 Apr 2013 16:54:00 +0530 Granules India announced its financial results for the fiscal year 2013 ended March 31, 2013 in which it consolidated net sales increased 17 percent to Rs 764 crore, while consolidated net profit increased 9 percent to Rs 33 crore. The company reported sales of Rs 204 crore, its highest ever, in Q4 FY13, an increase of 9 percent compared to the same quarter in FY12. In addition, PBT before F/X increased by 15 percent to Rs 18 crore. Granules also announced the completion of the expansion at its Gagillapur facility. The company has commenced operations of the new capacity and expects to scale up operations over the next several months. Due to the delay in the scale-up of the new capacity, margins slipped since the company incurred costs to run the new facility without a concurrent increase in production. The company expects margins to increase since production is increasing at the facility. "While we faced a setback in scaling-up our formulation expansion, we are optimistic for the future. Our strategy has enabled us to entrench ourselves within our industry and become synonymous with the products we produce. Due to our ability to provide high-quality products at a cost effective price, we have been able to work closely with market leaders which has resulted in sustainable revenue. We have made significant improvements over the past year and believe our foundation is stronger than ever. In FY14, we'll continue to shift to formulations which will result in an improvement in profitability," said Mr Krishna Prasad, managing director of Granules India. Granules is a fast growing pharmaceutical manufacturing company with world class facilities and is committed to manufacturing excellence, quality and customer service. The company produces Finished Dosages (FDs), Pharmaceutical Formulation Intermediates (PFIs) and Active Pharmaceutical Ingredients (APIs) for quality conscious customers in the regulated and semi-regulated markets. Granules support customers with unique value, extensive product range, proactive solutions and a global network of associates. It's global presence extends to over 300 customers in 60 countries through offices in India, US, UK, China and Colombia. Granules has the largest PFI facility in the world with an industry leading 6 ton batch size. The Company has its own ANDAs and dossiers which enable customers to quickly enter a market instead of filing their own applications. Granules has a highly skilled regulatory affairs department that can offer customers support and can help them navigate through regulatory issues. Granules has strengthened its advantages through its Operational Excellence (OE) department which looks at every step of the manufacturing process in order to gain efficiencies and has also implemented systems that have standardized quality and reduced variation The Company's OE program is regularly cited by MNCs as a "best in class" program and is the comparative advantage that lets Granules provide world-class quality products at a lower cost than its competitors. The adoption of the OE philosophy by Granules has earned it several recognitions including The Economic Times Manufacturing Excellence Awards 2011. Granules has recently been recognized as India's Most Admired Company in Exports and India's Most Admired Company in Bulk Drugs at the 5th Annual Pharmaceutical Business Leadership Awards. Additionally Granules has also received Outstanding Exports - Formulations Award 2011-12 from Pharmexcil. ]]> <![CDATA[Sanofi to deliver 1.7 billion doses of OPV for polio eradication]]> https://biospectrumindia.com/news/95/6983/sanofi-to-deliver-1-7-billion-doses-of-opv-for-polio-eradication.html https://biospectrumindia.com/news/95/6983/sanofi-to-deliver-1-7-billion-doses-of-opv-for-polio-eradication.html Fri, 26 Apr 2013 13:16:00 +0530 Sanofi Pasteur, the vaccines division of Sanofi has announced its commitment to provide 1.7 billion doses of Oral Polio Vaccine (OPV) to support the Global Polio Eradication Initiative's (GPEI) strategy to eradicate polio this decade. The doses of OPV will be delivered through 2017 for GPEI polio vaccination program.As a result of vaccination, polio cases have been reduced by 99 percent over 20 years, saving millions of children from paralysis. The GPEI has set the goal of eradicating the disease completely. Today only a few countries, namely Pakistan, Afghanistan and Nigeria are still affected by polio. In addition to OPV campaigns, the World Health Organization's (WHO) expert group on immunization (SAGE) recommends that all countries introduce at least one dose of injectable inactivated polio vaccine (IPV) in routine polio immunization programs. Sanofi Pasteur is responding to this strategy with the expansion of production capacities of IPV. "Wiping out polio for good is in sight and Sanofi Pasteur intends to remain an active contributor to achieve zero polio," said Mr Olivier Charmeil, president and CEO of Sanofi Pasteur. "We believe that the introduction of IPV in routine polio immunization will consolidate the tremendous progress achieved over the last decades and ensure a polio-free world for the future. Sanofi Pasteur has been a leading provider of polio vaccines and a supporter of the Global Polio Eradication Initiative for over 20 years. We intend to continue to be a major supporter of WHO and its partners to finish the job." Mr John Hewko, general secretary of the humanitarian service organization, Rotary International, a spearheading partner in the polio eradication initiative added, "Sanofi Pasteur's commitment of 1.7 billion vaccine doses comes at a crucial moment as we make the final push needed to end polio once and for all. On behalf of Rotary's 1.2 million members worldwide, I commend and thank Sanofi Pasteur for its steadfast support." Polio vaccination protects against disease from all three types of polio virus. SAGE now recommends that all countries introduce at least one dose of IPV in routine polio immunization programs to mitigate the risk of circulating Vaccine-Derived Poliovirus (cVDPV). The introduction of IPV will pave the way for the cessation of Oral Poliovirus Vaccine Type 2 (OPV2) since wild poliovirus type 2 has already been eliminated. It is hoped that, with this new vaccination schedule, wild poliovirus type 1 and 3 will also be eradicated within the next few years. Since 1988, the Global Polio Eradication Initiative, spearheaded by WHO, Rotary International, the US Centers for Disease Control and Prevention (CDC) and UNICEF with additional support from the Bill & Melinda Gates Foundation has achieved a 99 percent reduction of the number of polio cases worldwide. Polio is caused by three strains of poliovirus, types 1, 2 and 3. Wild poliovirus type 2 has already been eliminated, and it is hoped that poliovirus type 1 and 3 will be eradicated within a few years, definitively wiping polio from the surface of the earth. Over the past decades, Sanofi Pasteur has supplied more than 5 billion doses of OPV to UNICEF. In response to an outbreak in Egypt and a request from WHO, the company developed the first monovalent oral polio vaccine, which helped in declaring Egypt polio free in 2006. Between 1997 and 2005, Sanofi Pasteur donated over 120 million doses of OPV to respond to emergency situations in African countries affected by conflicts. Sanofi Pasteur is a leading supplier of IPV, available as a stand-alone poliovirus vaccine as well as a component of combination pediatric vaccines to immunize against many diseases in a single shot. Sanofi Pasteur, the vaccines division of Sanofi, provides more than 1 billion doses of vaccine each year, making it possible to immunize more than 500 million people across the globe. A world leader in the vaccine industry, Sanofi Pasteur offers the broadest range of vaccines protecting against 20 infectious diseases. The company's heritage, to create vaccines that protect life, dates back more than a century. Sanofi Pasteur is the largest company entirely dedicated to vaccines. Every day, the company invests more than EUR 1 million in research and development. ]]> <![CDATA[Biocon closes FY 2012-13 at Rs 2,538 crore]]> https://biospectrumindia.com/news/95/3235/biocon-closes-fy-2012-13-at-rs-2538-crore.html https://biospectrumindia.com/news/95/3235/biocon-closes-fy-2012-13-at-rs-2538-crore.html Fri, 26 Apr 2013 10:22:00 +0530 Indian's leading biotech group Biocon closes fiscal 2013 on a very strong note. "The key contributors to growth this fis cal have been Research Services, Branded Formulations and our growing biosimilar business, led by generic insulins. Biocon's insulin franchise continues to garner market share across India and emerging markets and now accounts for more than 10 percent of our sales. This quarter saw us enhance our partnership with Mylan through the re-licensing of our portfolio of generic insulin analogs. The partnership with Mylan endorses the intrinsic value of this asset and significantly reduces our burden of development costs involved in global commercialization," said chairman and managing director, Dr Kiran Mazumdar-Shaw. Click here to read about Biocon's partnership with Mylan for insulin analogs Highlights: FY2013 revenues at Rs 2,538 crore; EBITDA at Rs 596 crore; PAT at Rs 509 crore Biopharma business records 10 percent YoY to Rs 1,523 crore; Branded formulations registers 34 percent YoY to Rs 347 crore; Research services (Syngene and Clinigene) sees 36 percent YoY to Rs 557 crore; For FY13, the Group EBITDA and PAT margins were at 23 percent and 20 percent respectively Biocon receive d US$ 20 million as an upfront, for further development Performance financial highlights: Q4 FY13 revenues touched Rs 649 crore and R&D expenses were Rs 43 crore (11 percent of biopharma sales) EBITDA: Rs 124 crore (EBITDA Margin-19 percent) PAT at Rs 249 crore (PAT Margin-38 percent) Sales breakup for Q4: Biopharma : Rs 380 crore Research services: Rs 166 crore Branded formulations: Rs 84 crore ]]> <![CDATA[Government launches Universal Immunization Program in 8 states ]]> https://biospectrumindia.com/news/95/3070/government-launches-universal-immunization-program-in-8-states-.html https://biospectrumindia.com/news/95/3070/government-launches-universal-immunization-program-in-8-states-.html Thu, 25 Apr 2013 17:02:00 +0530 As per the information given by the Minister of State for Health and Family Welfare, Mr Abu Hasem Khan Choudhury in the parliament on April 23, 2013, "The pentavalent vaccination drive for infants under the Universal Immunization Program (UIP) of government of India has been started in Kerala, Tamil Nadu, Goa, Gujarat, Haryana, Jammu and Kashmir, Karnataka and Puducherry. The vaccine is given at the age of 6 weeks, 10 weeks and 14 weeks of age to infants (total 3 doses). Pentavalent vaccine protects against Diphtheria- Pertusis-Tetanus, Hepatitis B, and Haemophilus influenza-B. Pentavalent vaccine is provided as commodity assistance by Global Alliance for Vaccines and Immunization (GAVI) through United Nations Children's Emergency Fund (UNICEF). Several states like Assam, Rajasthan, Delhi, Punjab, Andhra Pradesh, Jharkhand, Madhya Pradesh, Bihar, Chhattisgarh, Uttarakhand and West Bengal have made request to the Government of India for introduction of Pentavalent vaccine in their state. However, no decision has been taken by the government in this regard. ]]> <![CDATA[Malaria control requires US $2.8 billion, says WHO]]> https://biospectrumindia.com/news/95/4312/malaria-control-requires-us-2-8-billion-says-who.html https://biospectrumindia.com/news/95/4312/malaria-control-requires-us-2-8-billion-says-who.html Thu, 25 Apr 2013 16:41:00 +0530 Today, on World Malaria Day, WHO recognized the significant accomplishments in preventing and controlling malaria, including in high-burden countries in sub-Saharan Africa, but highlighted the threat of antimalarial drug resistance in south-east Asia's greater Mekong sub-region, where an emergency response is now being launched. In total, an estimated US $5.1 billion is needed every year between 2011 and 2020 to achieve universal access to malaria prevention, diagnostic testing, and treatment around the world. Although many countries have increased domestic financing for malaria control, the total available global funding remained at US$ 2.3 billion in 2011 - less than half what is required. Many people still lack access to prevention measures such as mosquito nets and indoor residual spraying and are unable to obtain diagnostic testing and effective medicines to treat malaria infection. Equally worryingly, there is a real danger that a recent slowdown in mosquito net procurement could lead to resurgences and outbreaks. In 2012, malaria transmission occurred in 99 countries and territories around the world, putting an estimated 3.3 billion people at risk of illness. In 2010, an estimated 219 million cases occurred globally (range: 154 to 289 million) while the disease killed an estimated 660,000 people (range: 490,000 to 836,000), mostly children under five years of age. "In recent years endemic countries, including countries in sub-Saharan Africa, have made major headway in reducing new cases and deaths from malaria," says Dr Hiroki Nakatani, WHO's assistant director-general for HIV, TB, Malaria and Neglected Tropical Diseases. "But that progress could now be at risk. We are increasingly concerned by signs in the south-east Asia region that the malaria parasite is becoming resistant to some of the drugs that have helped make so much progress." Although major efforts are under way to develop new classes of antimalarials, there are no replacement products on the immediate horizon. "We need to invest more in order to tackle drug resistance," said Dr Mark Dybul, executive director of the Global Fund to Fight AIDS, Tuberculosis and Malaria. Also, WHO is launching a new Emergency Response to Artemisinin Resistance in Phnom Penh at an event hosted by the Cambodian Ministry of Health. Building on WHO's 2011 Global plan for artemisinin resistance containment, as well as a multi-partner evaluation of containment efforts to date, the emergency response framework will guide a major scale-up of WHO-recommended strategies to combat this public health threat. The framework urges affected countries to remove poor-quality antimalarial drugs and oral artemisinin-based monotherapies from circulation, as their use is compromising both the efficacy of artemisinin and the drugs combined with them as part of ACTs. According to WHO's latest assessment this month, at least 31 companies around the world are still marketing such monotherapies. Globally, 44 countries have withdrawn marketing authorization for these pills, but 14 countries continue to allow their marketing. The emergency response, which also includes the establishment of a WHO regional hub in Phnom Penh to support containment efforts, has received financial support from the Bill & Melinda Gates Foundation and AusAID. In addition, the Global Fund to Fight AIDS, Tuberculosis and Malaria has recently announced the allocation of US$ 100 million to tackle this threat over the next three years. While these are significant steps forward, WHO currently estimates that about US$ 300-350 million of additional funding would be required from 2013-15 to fully scale up malaria control and containment activities across affected countries in the Greater Mekong subregion. Antimalarial drug resistance, the ability of the malaria parasite to survive drugs, first became a global problem in the 1960s when the parasite developed resistance to chloroquine, the then widely-used antimalarial. Resistance first emerged in the Greater Mekong subregion and later spread to Africa, triggering a dramatic increase in malaria-related illness and death - particularly among children. ]]> <![CDATA[iPHEX 2013 to feature overseas delegates from 104 countries]]> https://biospectrumindia.com/news/95/7517/iphex-2013-to-feature-overseas-delegates-from-104-countries.html https://biospectrumindia.com/news/95/7517/iphex-2013-to-feature-overseas-delegates-from-104-countries.html Thu, 25 Apr 2013 13:15:00 +0530 The Maharashtra Chief Minister, Mr Prithviraj Chavan and special guest of honor, Mr Rajeev Kher, additional secretary, Ministry of Commerce and Industry in the presence of Dr G N Singh, Drug Controller General of India (DCGI) inaugurated iPHEX 2013, India's own pharmaceutical show organized by the Pharmaceuticals Export Promotion Council of India (Pharmexcil). iPHEX 2013 is held in Mumbai from April 24-26, 2013 at Bombay Exhibition Centre, Goregaon East, Mumbai. IPHEX 2013 will witness the presence of 250 stalls exhibiting Indian Pharma companies like Ranbaxy, Lupin, Glenmark, Mylan, MSN Labs, Ipca, Ind-Swift, Strides, Aurobindo, Mankind, to mention few, over 5,000 trade visitors including overseas buyer, delegates from highly regulated market like USA, Europe, Australia, New Zealand and 3,000 Pharmexcil registered members. Over 500 overseas buyers have been invited with the support of Ministry of Commerce and Industry Government of India. About 60 percent of stalls belong to SMEs which present a very robust, competent and competitive Indian pharma sector. Huge business opportunities are expected to emerge during the event. Additionally, over 40 senior regulatory from 20 countries like Ghana, Tanzania, Senegal, Taiwan, Vietnam, Philippine, Benin, Botswana, Burkina Faso, Egypt, Ghana, Niger, Nigeria, Seychelles, Uganda, Belaru, Haiti, Cuba, Dominic Republic, Mongolia, Srilanka, Zimbabwe, Ministry of Health officials and drug regulators chief from Maharashtra, Andhra Pradesh, Gujrat, Karnataka are present for IPHEX-2013. The presence of large number of drug regulators from overseas market is set to help Pharmexcil and its members to promote the quality and affordability aspect as envisaged in Brand India Pharma Campaign. The campaign has been initiated by the Ministry of Commerce and executed by Pharmaceuticals Export Promotion Council in association with India Brand Equity Foundation (IBEF). Elaborating on what differentiates iPHEX, Dr P V Appaji director general, Pharmexcil says, "iPHEX is slightly different from other international events held in India. In iPHEX, we are inviting overseas buyers at our cost and organizing one-to-one meeting with the buyers, organizing technical conferences where the invited drug regulators will be making presentations about drug regulatory procedures in their respective countries, for the benefit of Indian pharma industry. The unique point of iPHEX is that exhibitors are assured of fixed meetings with invited buyers from overseas countries. Indian Pharma Industry would immensely get benefited as there would be over 400 genuine pharma buyers and drug regulators from various countries and exhibitors would be having one-to-one meetings with them." On this occasion, Mr Bhavin Mehta, committee chief of iPHEX and CoA member, Pharmexcil added, "iPHEX 2013 will be the biggest industry exposition in India showcasing the diverse range of products and will include formulations, APIs, Ayush, nutraceuticals, health services, biotechnology and biotechnology products, and R&D services. Plan visits also will be organized for the interested drug regulators. iPHEX will be an annual event. Our attempt is to make iPHEX a face of Indian Pharma to the global community. We are sure to achieve this over the years." iPHEX 2013 is being organized by Pharmaceuticals Export Promotion Council of India (PHARMEXCIL) under the support of Ministry of Commerce and Industry, Department of Commerce, Government of India. Pharmexcil is a nodal agency to represent Indian Drugs, Pharmaceutical and Healthcare industry globally. It is mandated to help over 3,800 of its members to achieve excellence in export and facilitate overseas buyers to find suitable trade partners from Indian pharma industry. ]]> <![CDATA[Research institutes get funding boost of Rs 422 crore ]]> https://biospectrumindia.com/news/95/3205/research-institutes-get-funding-boost-of-rs-422-crore-.html https://biospectrumindia.com/news/95/3205/research-institutes-get-funding-boost-of-rs-422-crore-.html Tue, 23 Apr 2013 15:14:00 +0530 A major chunck of Rs 422 crore fund allocated by the major research organizations under the DBT in FY 2012-13, went to north-based research institutions or laboratories. While north recieved Rs 257 crore, it was Rs 128 crore and Rs 37 crore for south- and west-based institutes respectively. In Punjab, the National Agri Food Biotechnology Institution and Bioprocessing Unit, Mohali was given Rs 28 crore. The West Bengal-based National Institute of Biomedical Genomics (NIBMG), Kalyani was allocated Rs 28 crore. While the National Institute of Immunology (NII), New Delhi was allocated Rs 25 crore, the National Institute of Plant Genome Research (NIPGR) also located at New Delhi got Rs 36 crore. In the state of Haryana, Rs 27 crore was allocated to National Brain Research Centre (NBRC), Manesar, while The Translational Health Science & Technology Institute (THSTI) Faridabad recieved Rs 34 crore and the UNESCO Regional Centre for Education, Training and Innovation in Biotechnology, Faridabad was given Rs 34 crore during the cuurent fiscal year. The only organization to recieve funding in north-east was the Institute of Bioresources and Sustainable Development (IBSD), Imphal, Manipur. The institute recieved Rs 15 crore. The Institute of Life Sciences (ILS), Bhubaneswar in Orissa was allocated Rs 30 crore. DBT, which is the nodal agency for promoting biotechnology in the country, has been spending around RS 1,400 crore each year, to support R&D and innovation. The provision for DBT in 2012-13 is Rs 1,485 crore and nearly 40 percent of this will be devoted to research and development. Down south, the total funding amout was almost equally distrubuted among various institutes. In Andhra Pradesh, DBT allocated Rs 40 crore to the Centre for DNA Finger Printing and Diagnostics (CDFC), Hyderabad. The Hyderabad- based National Institute of Animal Biotechnology got Rs 15 crore. Rs 28 crore was granted to Karnataka-based Institute for Stem Cell Science and Regenerative Medicines, Bangalore whereas, Kerala-based Rajiv Gandhi Centre for Biotechnology (RGCB), Thiruvananthapuram was allocated Rs 25 crore. The only DBT institute to recieve Rs37 crore funding in western region was the National Centre for Cell Sciences (NCCS), Pune, Maharashtra. As per information revealed by the Union Minister of Science and Technology, Mr S Jaipal Reddy in parliament on April 22, 2013, the DBT funded a total of 14 research organizations accross India. "Generally there is a time lag in utilization of the allocated funds by the research institutions. Unspent balance in a particular financial year is adjusted while releasing the grant-in-aid for the next financial year," mentioned Mr Reddy. ]]> <![CDATA[Indian soldiers to undergo DNA profiling ]]> https://biospectrumindia.com/news/95/3218/indian-soldiers-to-undergo-dna-profiling-.html https://biospectrumindia.com/news/95/3218/indian-soldiers-to-undergo-dna-profiling-.html Tue, 23 Apr 2013 12:08:00 +0530 The pilot project titled, "Development of protocol for deoxy ribonucleotide (DNA) profiling (identification) and repository of personnel of armed forces" is currently in progress at Armed Forces Medical College, Pune. Initiated in the year 2012, the project is expected to go upto 2014, has been approved by the Armed Forces Medical Research Committee (AFMRC). As per the information given out by the Defense Minister, Mr AK Antony in the parliament on April 22, 2013, the objectives of the project are to devise a protocol for collection, preservation and transportation of blood samples of the soldiers, maintain absolute accuracy in personal information and tagging of specimen and to devise protocol for procedure for identifying service personnel from any fragment of body tissue. "Army has a well established procedure/ system for identification of a soldier in the forward/ battle zone. A solder is either part of a sub unit (section, platoon) deployed on the border and every one recognizes him due to his physical attributes, or he moves out with a companion. Never a soldier is left alone in these areas. In addition every personnel has two metallic discs, one tied to his neck and other on the wrist. These discs have his Army Number engraved for identification," said the Minister while speaking about the manual identification process. However, in the extreme conditions when the soldiers die due to mine blasts, the remains left are totally unidentifiable even by the family members. That is when the quick DNA profiling with the help of samples already deposited would of critical help. In USA, the collection of DNA samples was made mandatory from the soldiers in the year 1992. ]]> <![CDATA[Ministry of Health formulates National Urban Health Mission ]]> https://biospectrumindia.com/news/95/6139/ministry-of-health-formulates-national-urban-health-mission-.html https://biospectrumindia.com/news/95/6139/ministry-of-health-formulates-national-urban-health-mission-.html Mon, 22 Apr 2013 17:48:47 +0530 To address the healthcare needs of urban population, particularly urban poor, the Ministry of Health and Family Welfare, government of India has formulated National Urban Health Mission (NUHM) as a sub-mission under an over-arching National Health Mission (NHM) to be launched during the 12th Five Year Plan. For the 12th Five Year Plan (FYP) 2012-17, an amount of Rs 15,143 crore has been approved by the Planning Commission whereas the ministry proposed Rs 16,955 crore for NUHM during 12th FYP. However, for the year 2013-14 approved outlay for NUHM is Rs 1 crore only. It may be recalled that NUHM was a listed scheme under 11th Five Year Plan with an approved outlay of Rs 4,500 crore and Expenditure Finance Committee (EFC) also approved the scheme in its meeting held on September 12, 2008. However the scheme could not be launched. The proposed NUHM aims to improve the health status of the urban population particularly slum dwellers and other vulnerable sections by facilitating equitable access to quality healthcare with the active involvement of the urban local bodies (ULBs). It proposes to cover 779 cities and town including seven metros with population of fifty thousand and above. The proposal of National Urban Health Mission (NUHM) under an overarching National Health Mission (NHM) was discussed in the Expenditure Finance Committee (EFC) under the Chairmanship of the Finance Secretary and Secretary (Expenditure) on October 9, 2012. The EFC meeting recommended the proposal for approval of the cabinet with recommendation of Rs 22,507 crore during the 12th Five Year Plan with central share of Rs 16,955 crore. According to official release, a cabinet note on NUHM was sent to cabinet secretariat on January 24, 2013 for placing the same before the cabinet for consideration and approval. Cabinet considered the proposal relating to NUHM in its meeting held on February 21, 2013. However, the agenda item was postponed. ]]> <![CDATA[CMFRI develops unique marine cage culture technology]]> https://biospectrumindia.com/news/95/3899/cmfri-develops-unique-marine-cage-culture-technology.html https://biospectrumindia.com/news/95/3899/cmfri-develops-unique-marine-cage-culture-technology.html Mon, 22 Apr 2013 11:59:41 +0530 During his recent visit to the marine cage farm at Karwar, the Union Minister for Agriculture, Mr Sharad Pawar, appreciated the cage culture technology developed by Central Marine Fisheries Research Institute (CMFRI) and assured supports for establishment of brood banks, increase in the number of species cultivated and also utilize the natural seed resources without hampering the environment. In this regard, an installation of artificial reefs by CMFRI to utilize the natural resources for conservation of biodiversity, habitat protection and increasing production was highly appreciated by the Minister. The open sea cage technology developed, demonstrated and popularized by CMFRI is an example of transfer of scientific technology from lab to the field in a participatory mode for the benefit of stakeholders. Cultivation of high value fishes in sea cages in addition to fulfilling the primary need of food security by augmenting fish production has provided employment and livelihood opportunities to coastal inhabitants and increased their revenue. Sea cage farming engaging tribals in some coastal states is a positive step in empowering them with gainful occupation. Dr S Ayyappan, secretary, DARE and DG, Indian Council of Agriculture Research (ICAR), apprised the Agriculture Minister on the capture fisheries management in India and the way forward for enhancing fish production in the country. He also updated the minister on the need for establishing brood banks, satellite hatcheries and feed production units along the west coast to meet the seed and feed demands. Dr G C Pati, secretary, Department of Animal Husbandry, Dairying and Fisheries assured all support from National Fisheries Development Board (NFDB) and Ministry of Agriculture to CMFRI for enhancing production through cage culture and establishment of seed and brood banks. Dr G Syda Rao, director, CMFRI; Dr N P Singh, director, ICAR Research Complex for Goa; scientists from Kochi, Veraval, Mumbai, and Mangalore centres and several other dignitaries were also present on the occasion. A book entitled "Cage Aquaculture in India" published by CMFRI was also released by the dignitaries on board the vessel on April 19, 2013. Later, the dignitaries visited the laboratory-cum-office complex of Karwar Research Centre of CMFRI and the exhibition stalls arranged within the campus. The Minister interacted with dignitaries, researchers as well as with local farmers, entrepreneurs from different parts of India and tribals engaged in cage farming. ]]> <![CDATA[NRI's Sabinsa wins F&S 2013 award for unique technology]]> https://biospectrumindia.com/news/95/7892/nris-sabinsa-wins-fs-2013-award-for-unique-technology.html https://biospectrumindia.com/news/95/7892/nris-sabinsa-wins-fs-2013-award-for-unique-technology.html Mon, 22 Apr 2013 11:45:34 +0530 A non-resident Indian scientist's pioneering nutraceuticals company in the United States, have won a coveted laurel in its 25th year of its celebration, as New Jersey-based Sabinsa Corporation of pharmacist-scientist Dr Muhammed Majeed bagged the Frost & Sullivan's 2013 North American Integrated Prebiotic Delivery Technology Innovation Award. The honour comes in recognition of the company's Integrated Nutritional Composites (INC) technology that allows it to create a combination of prebiotics and probiotics. The bi-layer "synbiotics" technology delivers stable and active formulation of ingredients which may otherwise be incompatible or difficult to co-formulate, thus assuring effective working, according to Bangalore-based Sami Labs Limited, which owns the 1988-founded Sabinsa. The benefit of the technology has already begun reaching its consumers in India through Sami Direct, the 2010-established marketing arm of the parent company. Frost & Sullivan described Sabinsa's INC technology as, "an innovative, game-changing technology" in the prebiotic delivery and formulation market. "The bi-layer tablets enable the integration of incompatible ingredients and help explore different time-release profiles of the ingredients. They are also quite attractive due to their two-tone appearance," said Ms Arpita Mukherjee, research analyst with the California-located firm that provides customer-dependent market research and analysis besides growth strategy consulting and corporate training services. "The technology can be used for formulating bi-layer tablets with chemically incompatible ingredients, providing more flexibility for formulation manufacturers to integrate ingredients in a single approach," she further added. Sabinsa said the award validated the innovation that has always driven the company. "We're certainly honoured by this recognition," stated Dr Majeed, who migrated from his native Kerala to the US in 1975 to do his MS in industrial pharmacy from Long Island University and later a doctorate in the same field from St John's University, also in New York. Sabinsa had, earlier in 2008, received Frost & Sullivan's North American Personal Care Ingredient Green Excellence of the Year Award. That was in acknowledgment of its strategically balanced green product offering, proactive and sustainable marketing practices, and the continuous ability to satisfy client needs in an increasingly diverse and green-conscious market space. Born in Chavara near Kollam, Dr Majeed had founded Sabinsa with the objective of importing and marketing generic drugs into the US for the drug molecules coming off patent. By delving deep into the science of herbs, the company developed the concept of nutraceuticals which is aligned to "food as medicine" - and soon introduced into the US market a new line of products based on Indian herbal plants.It was Dr Majeed who introduced to the Americans that Ayurveda from India can act as a complete curative to their various ailments. By 2000, it became popular as the complementary medicine, now called "integrated medicine". Frost & Sullivan is in its 50th year in business with a global research organization of 1,800 analysts and consultants who monitor more than 300 industries and 2,50,000 companies. The company's research philosophy originates with the CEO's 360-Degree Perspective, which serves as the foundation of its TEAM Research methodology. This unique approach enables them to determine how best-in-class companies worldwide manage growth, innovation and leadership. ]]> <![CDATA[Orchid, Allecra ink pact to develop novel antibiotics]]> https://biospectrumindia.com/news/95/3929/orchid-allecra-ink-pact-to-develop-novel-antibiotics.html https://biospectrumindia.com/news/95/3929/orchid-allecra-ink-pact-to-develop-novel-antibiotics.html Fri, 19 Apr 2013 17:29:43 +0530 Chennai-based pharma firm, Orchid Pharma entered into a strategic partnership with Europe-based venture capital funded Allecra Therapeutics to develop novel antibiotics to combat multi-drug resistant bacterial infections. As part of its investment into Allecra, Orchid has assigned to Allecra IP (Intellectual Property) related to an antibiotic discovery program which will then be pursued through further trials by Allecra. Under the terms of the Agreement, together with shareholding, Orchid will also be paid an upfront sum and is eligible to receive further royalties and exit bonuses based on Allecra's progress. Allecra's â‚¬15 million Series A financing round was co-led by Edmond de Rothschild Investment Partners and Forbion Capital Partners. EMBL Ventures also participated. Orchid was represented by the law firm Latham and Watkins. Bacterial resistance to current antibiotics is widespread and growing exponentially leading to increased urgency to combat what has been called the "epidemic of antibiotic-resistance". Allecra will aim to contribute to this cause by developing new treatments which overcome emerging bacterial resistance mechanisms, thereby saving lives of patients whose infections may otherwise be inadequately treated. Commenting on this partnership, Mr K Raghavendra Rao, chairman and managing director, Orchid said, "We have always believed in building collaborative business models to achieving our vision. This strategic partnership with Allecra is yet another demonstration of how we can create value by harnessing the relative strengths of each company. Mr Nicholas Benedict, CEO, Allecra said, "To combat the increasing threat of bacterial resistance the medical community is trying to conserve the use of currently available antibiotics. At the same time, the biopharmaceutical industry is working to find new antibiotics. These objectives are complimentary activities in the increasingly urgent battle against bacterial resistance. Allecra has been formed in order to find new cures for some of the most widespread and hardest to treat resistant infections." ]]> <![CDATA[Biological E reduces price of pentavalent vaccine for GAVI]]> https://biospectrumindia.com/news/95/3228/biological-e-reduces-price-of-pentavalent-vaccine-for-gavi.html https://biospectrumindia.com/news/95/3228/biological-e-reduces-price-of-pentavalent-vaccine-for-gavi.html Fri, 19 Apr 2013 13:57:38 +0530 A supply agreement with Hyderabad based Biological E has made the five-in-one shot available to GAVI for just $1.19 per dose, compared to the 2012 weighted average price of $2.17.This new, more cost-effective price provides the opportunity for the GAVI Alliance to pay up to US$ 150 million less over the next four years compared with using lowest cost alternative suppliers. The contributions of vaccine companies from the developing world, especially India to allowing greater access to life saving vaccines have been acknowledged by stalwarts. "More affordable vaccines help us save and protect more children," said Bill Gates, co-chair of the Bill & Melinda Gates Foundation. "Today's announcement is a testimony to the vision of Biological E's Dr. Vijay K. Datla, who was committed to manufacturing vaccines at prices that make them one of the most cost-effective investments we can make in global health." Mahima Datla, Managing Director of Biological E also added,"This partnership demonstrates the growing role of developing world manufacturers in the sustainable supply of effective, affordable vaccines. We are proud that our work to provide affordable prices for a variety of countries means life-saving vaccines can reach the most underprivileged children in the world." UNICEF, an Alliance partner, managed the tender process for GAVI, which saw agreements made with Biological E, Crucell, GlaxoSmithKline, Serum Institute of India and new pentavalent supplier, LG Life Sciences of the Republic of Korea. The GAVI Alliance was created in 2000 to accelerate the introduction of new vaccines so that all children, no matter where they live, have the same access to this life-saving technology. National governments, donors and vaccine suppliers must all play their part to ensure infants in the poorest countries are protected.The partnership aggregates donor funding, pools demand from countries, and works with suppliers to deliver lower and more accessible pricing. This reduces risk to supplies, enabling all partners to benefit and, most importantly, ensuring that the world can urgently reach all children with the vaccines they need. Pentavalent vaccines combine the antigens for five infectious diseases in a single shot, namely diphtheria, tetanus, pertussis, hepatitis B and Haemophilus influenzae type B (Hib). Pentavalent is already GAVI's most widely used vaccine and by 2020 GAVI support for this vaccine will have helped to avert more than seven million deaths. "This is great news for children in the world's poorest countries and it shows that our innovative public-private partnership model is working well" said Dr Seth Berkley, CEO of the GAVI Alliance." A decade ago we had just one European supplier and a price of US$ 3.56. Today we have five suppliers, including two in India, and a price that is down to its lowest level yet. This marks the realisation of a vision that GAVI started a decade ago to create a healthy, competitive and sustainable global market for pentavalent vaccine. " Demand for pentavalent vaccine has been strong, with 70 of the 73 GAVI-eligible countries having already introduced it, and the three remaining countries - Somalia, Indonesia, and South Sudan - approved to do so. This new agreement is another example of how the GAVI Alliance model is delivering on the promises GAVI made at the London pledging conference in June 2011, when donors committed an additional US$ 4.3 billion towards GAVI's 2011-2015 programmes. In October, partners and donors will meet in Stockholm to review GAVI's progress. ]]> <![CDATA[Nueclear Healthcare opens molecular imaging center ]]> https://biospectrumindia.com/news/95/3233/nueclear-healthcare-opens-molecular-imaging-center-.html https://biospectrumindia.com/news/95/3233/nueclear-healthcare-opens-molecular-imaging-center-.html Thu, 18 Apr 2013 17:19:00 +0530 Nueclear Healthcare Ltd (NHL), the brainchild of Dr A Velumani, founder of Thyrocare Group, an industry leader, trend setter and innovators in Indian diagnostic industry, in association with GE Healthcare as technology partner announced the opening of its first molecular imaging centre for early, affordable cancer detection in Navi Mumbai. The NHL network of molecular imaging centres will have 12 medical cyclotrons that produce bio-markers required for cancer imaging and 120 GE Discovery PET/CT imaging scanners. While the first centre is opened at Navi Mumbai, five more centres will be commissioned in 2013. GE Discovery PET/CT systems installed at the centre will help doctors determine whether a suspicious growth is cancerous or benign in a single exam. Previously, doctors had to put patients through two separate scans to get similar information - with limited success. The release noted that NHL will establish a mega network of 120 molecular imaging centres around the country by 2015 with GE Healthcare as its technology partner. The hub and spoke model will help scale up affordable access to advanced molecular imaging technologies such as PET/CT required early detection of cancer. NHL proposes to offer PET/CT imaging at just Rs 10,000 compared to approximately Rs.18000- 25,000 patients pay today for same services. Sharing his views, Dr A Velumani, founder and managing director of Nueclear Healthcare Ltd (NHL) Mumbai said, "Cost has been one of the biggest barriers in advancing early cancer detection. We have removed the barrier of cost by reducing the cost to patient by half. We are following the same concept which made Thyrocare a household name today. If we make detection and treatment affordable, more people will come forward and the sheer volume will take care of our capital investments. We have a great partner in GE Healthcare and our visions match - make India a healthier country." Mr John Dineen, president and CEO, GE Healthcare, who inaugurated the center said, "At GE, we envision a day when cancer is no longer a deadly disease. Today's event reinforces our commitment to cancer and reflects our current integrated portfolio and GE Healthcare's $1billion R&D investment to advance oncology solutions by 2016. By partnering with Nueclear Healthcare Ltd (NHL) we can be at work for a healthier India by providing access to advanced affordable early cancer detection technologies to more people of India." The cancer burden in developing countries is reaching pandemic proportions. Cancer is one of the leading causes of death in India, with about 2.5 million cancer patients, 1 million added every year with a chance of rising five-fold by 2025 prompting Indian Council of Medical Research (ICMR) urging the Government of India to make cancer a notifiable disease. There is a high probability of treating Cancer if detected early - in stage I or stage II. However, over 70 percent of cancer is detected late at a very late stage in India, when treatment is less effective and costly. While low awareness is one significant reason, unavailability of early cancer detection facilities and availability of experts is the other significant reason. ]]> <![CDATA[Lupin receives favorable ruling for generic Yaz ]]> https://biospectrumindia.com/news/95/6885/lupin-receives-favorable-ruling-for-generic-yaz-.html https://biospectrumindia.com/news/95/6885/lupin-receives-favorable-ruling-for-generic-yaz-.html Thu, 18 Apr 2013 16:49:00 +0530 Lupin, the third largest Indian pharmaceutical company by sales announced that the US Court of Appeals for the Federal Circuit has ruled in its favor regarding its appeal of a previous judgment by a lower court for Bayer AG's Yaz oral contraceptive product. The company noted in a release that on April 16, 2013 the United States Court of Appeals for the Federal Circuit has ruled that United States Patent No. RE 37,564 (the RE '564 Patent) is invalid thereby reversing the district court's decision of validity. Confirming the same a Lupin spokesperson stated, "We are pleased with the ruling which paves the path for entry of generic product which would immensely benefit customers." Lupin is currently seeking approval from the US FDA for its generic and is working out its commercialization plan. Lupin's Generic Drospirenone and Ethinyl Estradiol Tablets (3 mg + 0.02 mg) of Bayer AG's Yaz tablets are indicated for prevention of pregnancy, to treat the symptoms of premenstrual dysphoric disorder (PMDD) for women and to treat moderate acne for women at least 14 years old only if the patient desires an oral contraceptive for birth control. The total sales for Branded and generic sales for the product stood at $361 million (IMS MAT Dec 2012). Lupin is the fifth largest and fastest growing generics player in the US (5.1 percent market share by prescriptions, IMS Health). The company is also the fastest growing top 10 generic pharmaceutical players in Japan and South Africa (IMS). For the financial year ended March 2012, Lupin's consolidated total income and Profit after Tax were $ 1.49 billion and $ 182 million respectively. ]]> <![CDATA[We need a green revolution in North East, says Assam CM ]]> https://biospectrumindia.com/news/95/3232/we-need-a-green-revolution-in-north-east-says-assam-cm-.html https://biospectrumindia.com/news/95/3232/we-need-a-green-revolution-in-north-east-says-assam-cm-.html Thu, 18 Apr 2013 11:38:00 +0530 Mr Tarun Gogoi, Chief Minister, Assam, inaugurated the 21st meeting of the ICAR Regional Committee, Region III at Assam Agricultural University (AAU), Jorhat. In his address, Mr Gogoi stressed on the need of green revolution in the region that has already proved instrumental in building up the food security of the nation. He appreciated the role of AAU and urged agricultural scientists to focus on emerging areas like marketing, value-addition, post-harvest processing to increase the profitability of farmers. He said development of flood resistant rice varieties and introduction of new crops can be very important for Assam and other states in the region. Mr Nilamoni Sen Deka, agricultural minister, government of Assam and Mr Yitachu, parliamentary secretary (veterinary and animal husbandry), government of Nagaland, addressed the audience raising critical areas of agriculture in the region. Dr S Ayyappan, secretary, DARE and director general, ICAR, in his address, complimented the vice chancellor, AAU for organizing the 21st meeting of the ICAR Regional Committee. In the 12th Plan, the concept of "smart farming for smart farmers" would be a thrust area, he said. He also highlighted the new initiatives of the ICAR during Plan period, such as Farmer FIRST, ARYA and Student READY. He further suggested that water harvesting could be done and may be encouraged in areas like Arunachal Pradesh. "The seed chain concept should be brought into functioning. Customized farm implements, drought-flood contingency plans, medicinal plants and plantation crops cultivation are other areas in which research and extension work need to be strengthened," he added. Earlier, Dr K M Bujarbaruah, vice chancellor, AAU delivered the welcome address and Dr Arvind Kumar, deputy director general, education, gave the background information and introduced the agenda in hand. Mr Arvind R Kaushal, additional secretary, DARE and secretary, ICAR; Dr S N Puri, vice chancellor, CAU, Imphal; DDGs and ADGs from ICAR, directors of ICAR institutes and directors of state agricultural departments from the North Eastern states also participated and graced the occasion. Six books were released and certificates of appreciation for four National Agricultural Innovation Project (NAIP) projects were given on this occasion. Dr S V Ngachan, director, ICAR Complex for NE Region, Barapani proposed the vote of thanks. ]]> <![CDATA[Agila and Pfenex enter into JV for developing six biosimilars]]> https://biospectrumindia.com/news/95/5046/agila-and-pfenex-enter-into-jv-for-developing-six-biosimilars.html https://biospectrumindia.com/news/95/5046/agila-and-pfenex-enter-into-jv-for-developing-six-biosimilars.html Wed, 17 Apr 2013 15:47:00 +0530 Pfenex and Agila Biotech, a subsidiary of Strides Arcolab have entered into a joint venture to develop, manufacture and commercialize an initial pipeline of six biosimilar products for the global market. Operating as a JV, wherein both parties will equally share in decision making regarding product development and commercialization, Agila Biotech will be a 51 percent equity stakeholder. The lead product for the joint venture is Interferon beta-1b, a biosimilar to Betaseron, indicated for relapsing-remitting and secondary-progressive forms of multiple sclerosis, commencing human clinical trials by Q4 2013. This multi-product joint venture combines Pfenex's industry-leading expertise in strain engineering and process development with Agila Biotech's biologics manufacturing and clinical development excellence. Under the terms of the agreement, Pfenex will assume primary responsibility for development of an optimized production strain, process and analytical package for each product, while Agila Biotech will be responsible for pre-clinical and phase I development, as well as cGMP manufacturing. The joint venture will then progress the products through phase III and into commercialization. Manufacture of the collaboration products will be carried out at Agila Biotech's state-of-the-art manufacturing facility being built with Bio-XCell at Nusajaya, Johor, Malaysia - a 160 acre site comprised of customized biotech facilities. Dr Bertrand Liang, CEO at Pfenex said, "One of the global challenges for the future of healthcare is to develop and produce products within the confines of a constrained cost environment. Biosimilars are and will play an increasingly important role in patient disease management. This venture between Pfenex and Agila Biotech will allow us to leverage our infrastructure for the development of safe, reliable and cost-effective therapies for patients to address unmet medical needs all over the world." "Successful foray into the biologics space for companies like Agila Biotech will allow us to not only leverage time and cost advantage of developing products in India and Malaysia, but also serve as a gateway to a vast region in South Asia, South-East Asia and the OIC region currently underserved as a result of the lack of high quality, cost effective biologics," said Dr Anand Iyer, CEO at Agila Biotech. Dr Iyer also noted that its facility in Malaysia represents a strategic move to bolster Agila Biotech's manufacturing presence in the region and tap into unmet global demand for quality biologics at affordable prices. ]]> <![CDATA[Roche launches cobas p 312 pre-analytical system ]]> https://biospectrumindia.com/news/95/3180/roche-launches-cobas-p-312-pre-analytical-system-.html https://biospectrumindia.com/news/95/3180/roche-launches-cobas-p-312-pre-analytical-system-.html Wed, 17 Apr 2013 15:41:00 +0530 Roche, a leader in research-focused healthcare with combined strengths in pharmaceuticals and diagnostics launched cobas p 312 fully automated pre-analytical system, designed for small to medium sized laboratories faced with limited space or lack of skilled manpower. The cobas 312 pre-analytical system is a stand-alone solution with online connectivity, enabling workflow efficiency on no more than one square meter footprint in the laboratory. With the introduction of the cobas p 312 pre-analytical system, Roche now offers a complete portfolio of automated sample management solutions for laboratories of all sizes: connected automation with Modular Pre-Analytics and the cobas p 501 and cobas p 701 sample storage and retrieval modules and non-connected solutions with the cobas p 312, cobas p 512 and cobas p 612 pre-analytical systems. The company noted that the system has two unique features;Unique customized layout flexibility and Seamless online connectivity. The cobas p 312's ergonomic design allows a customized sample rack layout and management. Such innovation in sample preparation and sorting offers maximum efficiency at minimal space requirements for highest flexibility with a throughput of 450 samples per hour. Full online connectivity to the Laboratory Information System (LIS) enables managers to seamlessly integrate the cobas p 312 into the laboratory's IT infrastructure. Its easy IT connectivity to the cobas pre- and post-analytical systems family allows laboratories to flexibly integrate into a Total Laboratory Automation (TLA). The company further noted that cobas p 312 aids efficiency, minimizes manual handling and offers accurate sample tracking throughout the whole process. For improved control, safety and service to clinicians, the cobas p 312 provides decapping, sorting and archiving of all common types of sample tubes within the laboratory´s Serum Work Area (SWA), hematology, coagulation and urinalysis. Health professionals reduce error prone manual routine processes and time consuming intervention of sample preparation while the potential of bio hazardous exposition decreases considerably. "Automation is one of the key drivers of high testing efficiency that laboratories are increasingly seeking today. By offering powerful yet compact pre-analytical automation, the new cobas p 312 makes it easier for all labs to access the benefits of automation, to help improve efficiency and raise productivity. Roche looks forward to continue introducing the latest technologies to India in helping to advance healthcare standards here," said Mr Lance Little, managing director of Roche Diagnostics Asia Pacific. ]]> <![CDATA[Suven secures 4 product patents for NCEs in China, Mexico, NZ]]> https://biospectrumindia.com/news/95/3182/suven-secures-4-product-patents-for-nces-in-china-mexico-nz.html https://biospectrumindia.com/news/95/3182/suven-secures-4-product-patents-for-nces-in-china-mexico-nz.html Wed, 17 Apr 2013 15:13:00 +0530 Suven Life Sciences (Suven), a biopharmaceutical company focused on discovering, developing and commercializing novel pharmaceutical products announced that it has secured four product patents, two from China (ZL 20088001440 and ZL 200880112735), one from Mexico (301421) and one from New Zealand (591833) corresponding to the New Chemical Entities (NCEs) for the treatment of disorders associated with neurodegenerative diseases and these patents are valid through 2028. The granted claims of the patents include the class of selective 5-HT compounds discovered by Suven and are being developed as therapeutic agents and are useful in the treatment of cognitive impairment associated with neurodegenerative disorders like Alzheimer's disease, Attention Deficient Hyperactivity Disorder (ADHD), Huntington's disease, Parkinson and Schizophrenia. With these new patents, Suven has a total of 10 granted patents from China, 14 granted product patents from Mexico and 14 granted product patents from New Zealand. These granted patents are exclusive intellectual property of Suven and are achieved through the internal discovery research efforts. Products out of these inventions may be out-licensed at various phases of clinical development like at phase I or phase II. "We are very pleased by the grant of these patents to Suven for our pipeline of molecules in CNS arena that are being developed for cognitive disorders with high unmet medical need with huge market potential globally" says Mr Venkat Jasti, CEO of Suven. Suven Life Science has 12 internally-discovered therapeutic drug candidates currently in pre-clinical stage of development targeting conditions such as ADHD, dementia, depression, Huntington's disease, Parkinson's disease and obesity in addition to developmental candidate SUVN-502 for Alzheimer's disease and Schizophrenia. ]]> <![CDATA[Daiichi Sankyo and Ranbaxy launch hybrid business in Brazil ]]> https://biospectrumindia.com/news/95/3166/daiichi-sankyo-and-ranbaxy-launch-hybrid-business-in-brazil-.html https://biospectrumindia.com/news/95/3166/daiichi-sankyo-and-ranbaxy-launch-hybrid-business-in-brazil-.html Wed, 17 Apr 2013 14:17:00 +0530 Daiichi Sankyo and Ranbaxy Laboratories on April 17, 2013, announced synergy in Brazil to expand the business of both companies in the country. As part of this synergy, Ranbaxy will support Daiichi Sankyo's Brazilian subsidiary, Daiichi Sankyo Brasil Farmaceutica Ltda (Daiichi Sankyo Brazil), to enter the branded generics market, in addition to its established business of providing innovative products. Diachii Sankyo Brazil with 314 employees, founded in 1962, recorded the sales of 6.7 billion yen (approximately $85 million) in FY 2011. Ranbaxy's Brazilian subsidiary, Ranbaxy Farmaceutica Ltda would continue to independently promote Ranbaxy's generic products and also enter into branded generics in Brazil. The pharmaceutical market in Brazil is the biggest in Latin America, and it is expected to become the fourth biggest in the world in 2016. In Brazil, Daiichi Sankyo has built up its market presence with innovative pharmaceuticals through Daiichi Sankyo Brazil. On the other hand, Ranbaxy markets its generic products in Brazil through its subsidiary, Ranbaxy Farmaceutica Ltda. Founded in 1999, the company having employee strength of 72 persons, recorded the sales of $20.5 million in FY 2012. With this synergistic collaboration, the Daiichi Sankyo Group will expand its presence in Brazil through its hybrid business model promoting innovative, branded generic and generic pharmaceuticals. Ranbaxy's continued focus on R&D has resulted in several approvals, in developed and emerging markets many of which incorporate proprietary Novel Drug Delivery Systems (NDDS) and technologies, developed at its own labs. The company has further strengthened its focus on generics research and is increasingly working on more complex and specialty areas. Ranbaxy serves its customers in over 150 countries and has an expanding international portfolio of affiliates, joint ventures and alliances, ground operations in 43 countries and manufacturing operations in 8 countries. Ranbaxy is a member of the Daiichi Sankyo Group. Through strategic in-licensing opportunities and its hybrid business model with Daiichi Sankyo, a leading global pharma innovator headquartered in Tokyo, Japan, Ranbaxy is introducing many innovator products in markets around the world, where it has a strong presence. This is in line with the company's commitment to increase penetration and improve access to medicines, across the globe. ]]> <![CDATA[GE partners with HCG to advance cancer care in India]]> https://biospectrumindia.com/news/95/3153/ge-partners-with-hcg-to-advance-cancer-care-in-india.html https://biospectrumindia.com/news/95/3153/ge-partners-with-hcg-to-advance-cancer-care-in-india.html Wed, 17 Apr 2013 14:13:00 +0530 Healthcare Global Enterprises (HCG) and GE Healthcare announced a new partnership agreement to work together and elevate cancer care infrastructure in India. An initial pilot project setting up a cancer care centre in Bangalore will be the first step in this direction and GE will be the technology partner in this endeavour. This new partnership adds to the existing collaboration between GE and HCG on cancer biomarkers for improved cancer management. GE and HCG are committed to improve access to quality cancer care in India. The pilot project in Bangalore is expected to provide insights into methods of cost effective and quality cancer care. With insights from this project and by partnering with like-minded investors/ healthcare providers, GE and HCG hope to scale up and spread the cancer detection and treatment facilities to tier II and III towns, through a proposed hub and spoke business model. GE and HCG also propose to address the challenges of shortage of skilled manpower through education facilities and enhance disease awareness among general practitioners and patients. "At GE, we envision a day when cancer is no longer a deadly disease. Scaling up of cancer care at affordable costs requires disruptive solutions and willing partners. Our renewed partnership with Healthcare Global Enterprises, our long standing partner and expert in the fight against cancer, we hope to propel one of the most critical needs in cancer care in India - access to early detection and treatment technologies, education and building awareness" said Mr John Dineen, president and CEO, GE Healthcare. Dr BS Ajaikumar, chairman, HCG Enterprises, expressed happiness in the direction the new partnership is taking to address cancer care and said, "GE is a technology leader with tremendous expertise in R&D and disruptive innovations gathering knowledge from around the world. HCG is specialist in cancer care, and education with a dedicated network of 26 centres treating nearly 100,000 patients a year. And our goal is common - putting an end to cancer. We are very pleased to join our hands to set up this centre of excellence that will re-define cancer care in India and around the world". He further said, "The fight against cancer requires more willing partners. This partnership is not limited to GE and HCG alone. We hope to attract healthcare providers and investors join us in this journey." GE Healthcare has committed $1 billion towards accelerating research and development of advanced oncology solutions. GE Healthcare offers a wide portfolio for oncology and a strategy that combines cellular research, medical imaging, laboratory diagnostics, biopharmaceutical manufacturing technologies, and information technology. These innovative technologies help the oncology community increase their understanding of the causes and progression of cancer and help physicians make more personalized cancer treatment and management decisions. The cancer burden in developing countries is reaching pandemic proportions. Cancer is one of the leading causes of death in India, with about 2.5 million cancer patients, 1 million new cases added every year and with a chance of disease rising five-fold by 2025 Indian Council of Medical Research (ICMR) has urged the Government of India to make cancer a notifiable disease.There is a high probability of treating cancers if detected early - in stage I or stage II. As per a Boston Consulting Group study, 70-80 percent of cancer patients are diagnosed late when treatment is less efficient and 60 percent of them do not have access to quality cancer treatment. Out of 300+ cancer centres in India, 40 percent are not adequately equipped with advanced cancer care equipment. This study further suggests India will need at least 600 additional cancer care centres to meet the requirements by 2020. ]]> <![CDATA[Cipla launches first Etanercept biosimilar in India]]> https://biospectrumindia.com/news/95/3595/cipla-launches-first-etanercept-biosimilar-in-india.html https://biospectrumindia.com/news/95/3595/cipla-launches-first-etanercept-biosimilar-in-india.html Wed, 17 Apr 2013 13:12:00 +0530 Cipla, today, announced the launch of the first biosimilar of Etanercept in India; under the brand name 'Etacept'. The introduction of Etacept also signals Cipla's entry into the biologic segment offering an option to the patients suffering from rheumatic disorders at a lower cost. Etacept, used in the treatment of rheumatic disorders, is manufactured by a China-based company Shanghai CP Guojian Pharmaceutical and will be marketed by Cipla in India. Etacept is available as a lyophilized powder to be given by subcutaneous injection. It is available across the country at Rs. 6,150/- and the recommended dose for adults is 25mg twice weekly by subcutaneous injection. Commenting on the launch of Etacept, Dr. Jaideep Gogtay, Medical Director, Cipla said, "The higher cost of biologics has been a major hindrance, limiting its affordability and accessibility to millions of patients. We believe that introducing Etacept at a lower cost (30% lesser as compared to the innovator) will enable access of this drug to a greater number of patients in India. This can be enhanced further if we consider the results of a recent study that showed in patients who were successfully treated with Etanercept for 6 months, a 50% reduced dose worked just as well as continuing the current dose." Rheumatic Disorders are chronic inflammatory disorders affecting the joints, characterized by pain, redness, swelling and loss of function in several joints. It can lead to joint damage and deformities. If left undiagnosed and untreated, this could lead to permanent disability and at times could lead to mortality. However, rheumatic disorders can be controlled by early diagnosis and treatment.Currently there are DMARDs (Disease modifying anti-rheumatic drugs) which are considered to be the first line of treatment for rheumatic disorders. However, approximately 40% of the patients are not controlled on these drugs. In such cases, biologics like Etanercept play a significant role in controlling the disease activity and make a positive difference in the lives of these patients. ETACEPT contains Etanercept, a biologic produced by recombinant DNA technology. Etacept (Etanercept) binds to TNF-Î±, a cytokine that plays a very important role in the inflammation and joint damage in rheumatic disorders. It helps in modifying the course of the disease and prevents further damage to the joints. Etacept (Etanercept) is approved in the management of rheumatic disorders like rheumatoid arthritis, ankylosing spondylitis, juvenile idiopathic rheumatoid arthritis and psoriatic arthritis.Since its launch in 2006 in China by Shanghai CP Guojian Pharmaceutical over 50,000 patients have been treated with Etanercept. Clinical efficacy and the safety of the drug have also been well established in Indian patients. Cipla's state-of-the-art R&D centre has given the country and the world many firsts. This includes the evolutionary AIDS cocktail for less than a dollar a day. The company has over 34 manufacturing facilities across India, and manufactures 2,000+ products in 65 therapeutic categories.With a turnover of over US $ 1.4 billion, Cipla serves doctors and patients in over 170 countries. ]]> <![CDATA[iPHEX 2013 kick starts from April 24]]> https://biospectrumindia.com/news/95/6590/iphex-2013-kick-starts-from-april-24.html https://biospectrumindia.com/news/95/6590/iphex-2013-kick-starts-from-april-24.html Tue, 16 Apr 2013 16:12:54 +0530 The Pharmaceuticals Export Promotion Council of India (Pharmexcil), recently held a curtain raiser of iPHEX 2013, India's own pharmaceutical show under the support of Ministry of Commerce & Industry, Department of Commerce, and Government of India. iPHEX 2013 will be held in Mumbai from 24-26 April 2013 at the Bombay Exhibition Centre. iPHEX 2013 will see the presence of 200 stalls exhibiting Indian pharma and over 5000 business visitors including overseas buyers and 3000 Pharmexcil registered members. Over 400 overseas buyers have been invited with the support of Ministry of Commerce and Industry Government of India. About 60% of stalls belong to SMEs which present a very robust, competent and competitive Indian pharma sector. Huge business opportunities are expected to emerge during the event. Over 40 senior regulatory from 20 countries like Ghana, Tanzania, Senegal, Taiwan, Vietnam, Philippines and many other countries and Ministry of Health officials will be coming for IPHEX-2013. The presence of large number of drug regulators from overseas market will immensely help Pharmexcil and its members to promote the quality and affordability aspect as envisaged in Brand India Pharma Campaign. The campaign has been initiated by Ministry of Commerce and executed by Pharmaceuticals Export Promotion Council in association with I.B.E.F. Elaborating on the announcement, Dr. P V.Appaji director general, Pharmexcil says, "Indian Pharma Industry would immensely get benefited as there would be over 400 genuine pharma buyers / Drug regulators from various countries and exhibitors would be having one-to-one meetings with them." "iPHEX is slightly different from other international events held in India. In iPHEX, we are inviting overseas buyers at our cost and organizing one-to-one meeting with the buyers, organizing technical conferences where the invited Drug Regulators will be making presentations about Drug Regulatory procedures in their respective countries, for the benefit of Indian Pharma industry. The unique point of iPHEX is that exhibitors are assured of fixed meetings with invited buyers from overseas countries," further added by Dr P V Appaji. On this occasion, Mr. Bhavin Mehta Committee Chief of IPHEX and CoA member, Pharmexcil said, "iPHEX 2013 will be the biggest industry exposition in India showcasing the diverse range of products and will include Formulations, APIs, Ayush, Nutraceuticals, Health Services, Biotechnology and Biotechnology Products, R & D Services etc. Technical seminars will be organized where the invited drug regulators will make presentations on drug regulatory procedures of their respective countries. Plan visits also will be organized for the interested drug regulators. iPHEX will be an annual event. Our attempt is to make iPHEX a Face of Indian Pharma to the global community. We are sure to achieve this over the years." ]]> <![CDATA[Indian farmers to learn technical know-how from Malaysia ]]> https://biospectrumindia.com/news/95/1310/indian-farmers-to-learn-technical-know-how-from-malaysia-.html https://biospectrumindia.com/news/95/1310/indian-farmers-to-learn-technical-know-how-from-malaysia-.html Tue, 16 Apr 2013 11:42:00 +0530 An orientation meeting was organized for farmers' delegation visit to Malaysia during April 14-23, 2013 under the farmers exchange program between the Association of Southeast Asian Nations (ASEAN) member states and India at National Agricultural Science Complex (NASC), New Delhi on April 13, 2013 Dr K D Kokate, deputy director general (DDG) (Agricultural Extension), ICAR inaugurated the meeting and briefed the gathering about the ASEAN-India Farmers Exchange Programme. He also informed that first event under ASEAN-India farmers exchange programme was successfully conducted during December 19-30, 2012 in India. In this visit, 18 farmers from nine ASEAN member states visited various ICAR institutes, state agriculture universities, KVKs and farmer's field. Dr Kokate hoped that orientation meeting will help the farmers to prepare themselves in learning about various technologies and the best agricultural practices across the ASEAN countries. Dr A M Narula, ZPD, Zone-1, Ludhiana will lead the delegation in this 10-day visit. The delegation will visit farmers' agricultural projects and various historical places in Malaysia. The delegation comprises 18 farmers from 17 states. Dr V Venkatasubramanian, ADG (Agricultural Extension), Dr Y R Meena, additional commissioner (Extension) , Department of Agriculture and Cooperation (DAC), Dr V P Chahal, principal scientist, Agricultural Extension and Dr P Adhiguru, principal scientist, Agricultural Extension, ICAR were also present on the occasion. ]]> <![CDATA[Sun Pharma recieves tentative USFDA approval for Januvia]]> https://biospectrumindia.com/news/95/5174/sun-pharma-recieves-tentative-usfda-approval-for-januvia.html https://biospectrumindia.com/news/95/5174/sun-pharma-recieves-tentative-usfda-approval-for-januvia.html Mon, 15 Apr 2013 15:33:00 +0530 The US FDA has granted Sun Pharmaceuticals two tentative approvals for its Abbreviated New Drug Applications (ANDA) for generic version of Januvia, Sitagliptin Tablets and generic version of Glumetza, Metformin HCl extended-release tablets. Sitagliptin tablets, are therapeutic equivalents of Merck Sharp & Dohme Corporation's (MSD) Januvia tablets. Januvia recently found itself in the news for legal reasons, when MSD has filed a patent suit in India's Delhi High Court against Glenmark, alleging a violation of its patent for blockbuster anti-diabetes drugs Januvia and Janumet. Sun Pharma had earlier entered into an agreement with MSD for marketing, promoting and distributing MSD's diabetes products in India, including Januvia and Januvet in 2011. Sitagliptin tablets have annual sales of approximately USD 2.7 billion in the US. Sitagliptin tablets are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type-2 diabetes mellitus. Metformin HCl extended-release tablets are therapeutic equivalents of Santarus Glumetza tablets. Metformin HCl extended-release tablets have annual sales of approximately USD140 million in the US and are indicated as an adjunct to diet and exercise to improve glycemic control in adults with type-2 diabetes mellitus. ]]> <![CDATA[Lupin launches oral contraceptive pills]]> https://biospectrumindia.com/news/95/7005/lupin-launches-oral-contraceptive-pills.html https://biospectrumindia.com/news/95/7005/lupin-launches-oral-contraceptive-pills.html Mon, 15 Apr 2013 14:40:13 +0530 Lupin Pharmaceuticals recently received final approval for its Daysee Tablets (Levonorgestrel and Ethinyl Estradiol tablets and Ethinyl Estradiol tablets) from the United States Food and Drugs Administration (USFDA) to market a generic version of Teva Branded Pharm.'s Seasonique Tablets. Lupin has already commenced shipping the product. Lupin's Daysee tablets is indicated for use by women to prevent pregnancy. Lupin's Daysee tablet is available in extended-cycle wallets each containing a 13-week supply of tablets: 84 light blue tablets, each containing 0.15 mg of Levonorgestrel and 0.03 mg of Ethinyl estradiol, and 7 mustard tablets, each containing 0.01 mg of Ethinyl estradiol. The total sales for branded and generic sales for the product stood at USD 161 million according to IMS MAT Dec 2012. Lupin is the 5th largest and fastest growing generics player in the US (5.1% market share by prescriptions according to IMS Health) and the 3rd largest Indian pharmaceutical company by sales. IMS Health says that,the company is also the fastest growing top 10 generic pharmaceutical players in Japan and South Africa For the financial year ended March 2012, Lupin's consolidated total income and profit after tax were Rs. 70,972 million (USD 1.49 billion) and Rs.8,676 million (USD 182 million) respectively. ]]> <![CDATA[Persistent Systems launches single platform solution for pharma packaging]]> https://biospectrumindia.com/news/95/6012/persistent-systems-launches-single-platform-solution-for-pharma-packaging.html https://biospectrumindia.com/news/95/6012/persistent-systems-launches-single-platform-solution-for-pharma-packaging.html Fri, 12 Apr 2013 15:27:00 +0530 Pune-based Persistent Systems recently launched PaxPharma, a compliance-based, Design to Print (D2P) automation solution designed specifically for pharmaceutical packaging and product lifecycle management. This is Persistent's newest offering in the Paxpro Enterprise Collaboration Solution. It is said to be first-of-its-kind for the pharmaceutical industry, delivering the entire D2P supply chain on one easy to use platform - from NPI/NPD, product design and CAD, to labeling, artwork management, PLM and document lifecycle management for pharma covigilance. Mr Ram Pazhayannur, vice president, Paxpro Business Unit, Persistent Systems elaborated about the product, "PaxPharma is a solution that helps pharma companies automate their entire product lifecycle - from new product introduction, to financial planning, bills of materials management, artwork & labeling management and label change management from pharmacovigilance. The existing PaxPharma solution can be extended here for biologics/vaccines as well." A unique feature is said to be the enhanced user experience through a fully integrated solution with secure data transfer across modules that significantly helps reduce human error and ensures regulatory compliance, and improves time to market.Also, PaxPharma is offered as a hosted solution, hence there is zero IT overhead for the customer. He adds, "PaxPharma includes a unique FDA rules database module that manages the rules and regulations set by the FDA for each product type, from OTC drug to cosmetics. This module automatically selects several of the FDA rules based on product attributes specified by the labeling specialist - greatly reducing errors and providing significant time savings. Near print-ready Drug Fact Templates (DFT's) and labeling documents can be produced using this module allowing marketing managers to have better control of their artwork and labeling assets while reducing dependency on graphic artists and post production iterations." About the product reception since its launch he says, "We have had very good response thus far and we are optimistic of the coming months as well. Currently we are in late stage discussions with few a pharma customers. "Persistent Systems has commented that, currently there are no prospects in India, but they will be launching a solution designed for the Indian market soon, as well." ]]> <![CDATA[Shasun Pharma to manufacture and commercialize Alzheimers drug]]> https://biospectrumindia.com/news/95/7429/shasun-pharma-to-manufacture-and-commercialize-alzheimers-drug.html https://biospectrumindia.com/news/95/7429/shasun-pharma-to-manufacture-and-commercialize-alzheimers-drug.html Thu, 11 Apr 2013 17:00:32 +0530 Shasun Pharmaceuticals and Debiopharm Group, a Swiss-based global biopharmaceutical group have entered into a licensing agreement for the manufacturing and commercialization of Huperzine-A. Huperzine-A is a potent and reversible acetylcholinesterase inhibitor and clinical studies have shown a significant improvement in memory deficit and cognitive performance in patients with Alzheimer's disease. Huperzine-A is commercially available through Shasun Pharmaceuticals. According to the terms of the agreement, Shasun Pharmaceuticals will be able to use the Debiopharm technology for the manufacture of synthetic Huperzine-A under GMP quality conditions and commercialize it in pharmaceutical and nutraceutical markets.The manufacturing technology involves a 10-stage chemical synthesis process including a complex chiral organometallic step as a key transformation of the Huperzine-A structure. The synthesis is a result of a joint collaboration between Shasun's research centers in Chennai and the UK. This technology was recently recognized and awarded at the North East of England Process Industry Cluster (NEPIC), Innovation Awards in 2012. NEPIC is a stand-alone company created to represent the 500+ Pharmaceutical, Biotechnology, Specialty Chemical, Polymer & Rubber, Petrochemical & Commodity Chemical companies based in the North East of England. Commenting on the agreement, Dr Mauvernay, President and founder of Debiopharm Group said, "We are delighted to continue our collaboration with Shasun Pharmaceuticals .Clinical studies have demonstrated the drug to enable significant improvement in both memory deficit and cognitive performance and we are excited to have the opportunity to add value to this technology while contributing to improve people's quality of life." Dr Michel Spagnol, President of Shasun Pharmaceuticals added, "We are very proud of this achievement, resulting from a very close collaboration with Debiopharm. It underlines our commitment to delivering cutting-edge science in all our processes through our global research and development network." Huperzine-A is commercially available through Shasun Pharmaceuticals Ltd. Debiopharm Group is a Swiss-based global biopharmaceutical group of companies with a focus on the development of prescription drugs that target unmet medical needs. The group in-licenses, develops and/or co-develops promising biological and small molecule drug candidates having reached clinical development phases I, II or III, as well as earlier stage candidates. It develops its products for global registration and maximum commercial potential. The products are out-licensed to pharmaceutical partners for sales and marketing. Debiopharm is also active in the field of companion diagnostics with a view to progressing in the area of personalized medicine. Debiopharm independently funds the worldwide development of all of its products while providing expertise in pre-clinical and clinical trials, manufacturing, drug delivery and formulation, and regulatory affairs. ]]> <![CDATA[Cost effective way to produce therapeutic proteins ]]> https://biospectrumindia.com/news/95/1045/cost-effective-way-to-produce-therapeutic-proteins-.html https://biospectrumindia.com/news/95/1045/cost-effective-way-to-produce-therapeutic-proteins-.html Thu, 11 Apr 2013 14:59:00 +0530 "It is like making ice creams!", mentioned Dr Ashok Kumar of IIT, Kanpur, while enthusiastically talking about the process to freeze gels in the 'use and throw' portable cryogel based bioreactors. He explains further, "Cryogels composed of either polyacrylamide (PAAm) coupled to gelatin or semi-interpenetrating PAAm-chitosan are synthesized by free-radical polymerization at - 12°C. Hybridoma cells are immobilized over the cryogel bioreactor and incubated for 48 hours. Medium is circulated thereafter at 0.2 ml min - 1 and bioreactors can be run continuously for 60 days." This new process developed by him along with his team at Biological science and bioengineering department, for the production of therapeutics from mammalian cell culture, may work wonders for researchers in the private and public set ups. This cryogel-based disposable bioreactor matrix, which has been used for production of protein therapeutics such as urokinase and monoclonal antibodies (mAbs), may also be open for other usages as well. The research paper recently found place in prestigious Nature protocol magazine's online edition on April, 04, 2013. The importance of such bioreactors is that they are very cost effective as compared to the ones available in the market especially for mamamlian cell culture. Dr Kumar believes that because of high cost of these products, the final drug that comes out is is also priced heavily. "Another plus point is that these bioreactors don't have any setting up issue due to comparatively small size", he told BioSpectrum over phone. Prior to his 9 year old stint at IIT, Kanpur, where he joined in 2004, Dr Kumar completed his Ph.D jointly from IIT Roorkee, and the Institute of Genomics and Integrative Biology (IGIB), Delhi. Following that he had also continued his post doctoral research in Sweden and Japan. His research all along has been focussed on the design and development of new smart polymeric biomaterials and supermacroporous matrices for the cultivation of cells and development of integrated bioprocess for the product recovery. Speaking further on the product, Dr Kumar says, "These bio-reactors are incomparable with the permanent reactors. This is a closed system type of reactor and media can be changed after one round. It can last upto two rounds and then can be replaced with another one. The material used in making it already FDA approved and no regulatory approval is required as long as it is use for production of therapeutic proteins at the laboratory level for the research purpose." The cryogel-based packed-bed bioreactor can be formulated as a monolith or as beads. It also has an efficiency four times what can be obtained using a tissue-culture flask, a high surface-to-volume ratio and effective nutrient transport. The project was funded by the department of biotechnology (DBT), government of India with Rs 1 crore and now there has been renewed efforts by the Dr Kumar's team to explore uses of the bioreactor for other purposes as well. Enthusiastic about its possible utilization by the industry, Dr Kumar says that he is very open to the idea and wants the product to reach the ultimate beneficiaries. He has been approached by few of the companies in Japan. Priced at the rate as low as Rs 1000, this high efficiency make disposable bioreactors are feasible for small-scale therapeutic development and initial clinical trials. ]]> <![CDATA[India vaccine regulations meet global standards: WHO]]> https://biospectrumindia.com/news/95/1275/india-vaccine-regulations-meet-global-standards-who.html https://biospectrumindia.com/news/95/1275/india-vaccine-regulations-meet-global-standards-who.html Thu, 11 Apr 2013 11:29:00 +0530 The National Regulatory Authority of India (NRA) and affiliated institutions meet World Health Organization (WHO) published indicators for a functional vaccine regulatory system. A WHO-led team of international experts from eight countries came to this conclusion at the end of a comprehensive review from 10-14 December 2012. Commenting on this achievement, Mr Ghulam Nabi Azad, Union Minister for Health and Family Welfare said, "The Central Drugs Standard Control Organization in collaboration with WHO, has made exemplary efforts towards this achievement. The Government of India has decided to further strengthen the Central as well as the State Drugs Regulatory Systems during the 12th Five Year Plan (2012-17) and looks forward to strengthening our collaboration with WHO towards this end." "We welcome this positive development. It reaffirms faith in India's regulatory system and also reiterate country's strength for pharmaceutical sector. The effective regulatory oversight of vaccines is especially crucial for India which is a major vaccine producer and also supplier across the globe," said Mr Keshav Desiraju, Secretary, Health and Family Welfare, Government of India. India is a major vaccine producer that has 12 major vaccine manufacturing facilities. These vaccines are used for the national and international market (150 countries), which makes India a major vaccine supplier across the globe. In 2012, India had seven vaccine manufacturers producing 67 prequalified vaccines (dosage forms). Currently 16 vaccines are prequalified by WHO and exported through United Nations agencies. More than 70% of all measles vaccines used globally are produced in India. "This is indeed a great achievement and we would like to congratulate the Ministry of Health & Family Welfare and its affiliated institutions- Central Drugs Standards Control Organization (CDSCO), Central Drugs Laboratory, Kasauli, Immunization Division of the Ministry of Health and Family Welfare, and other relevant institutions, engaged in the regulation, control and testing of vaccines," said Dr Lahouari Belgharbi, WHO Team Leader for the NRA Assessment, Quality, Safety and Standards Team, Department of Immunization, Vaccines and Biologicals of the World Health Organization. "WHO had scaled up its technical support to the Indian NRA over the past several months in the context of this assessment. The recent success is a culmination of intensive effort by CDSCO, in collaboration with WHO, to implement a roadmap to strengthen capacity for regulation of vaccines. WHO will continue to support development of the NRA through technical advice, training and capacity building. We welcome this positive outcome. It shall go a long way in reaffirming the joint mutual strategic priority under the WHO's new Country Cooperation Strategy with India (2012-17), of supporting an improved role of India in global health, including strengthening the pharmaceutical sector and drug regulatory capacity," said Dr Nata Menabde, WHO representative to India. "India is one of the largest manufacturers and exporters of vaccines world-wide, reinstating our thrust on maintaining highest quality and efficacy of the products that are manufactured within our country. I am happy that we have been able to strengthen and enhance the current regulatory system as per the spirit of the Mission of CDSCO and the requirements of the World Health Organization to ensure safety and efficacy of the products that are manufactured and exported from India," said Dr G.N Singh, Drugs Controller General (India). One of the requirements to become eligible and to retain the prequalification status is to have a National Regulatory Authority (NRA) assessed as functional against the WHO published NRA indicators. The regulatory functions of the Indian NRA (Central Drugs Standards Control Organization) and its affiliated institutions were assessed for compliance against the revised WHO NRA indicators endorsed by the international consultation of experts in 2011. In addition to the general framework for the system, the following regulatory functions were evaluated: marketing authorization and licensing; post-marketing surveillance, including for adverse events following immunization; lot release by the national regulatory authority; laboratory access; regulatory inspections of manufacturing sites and distribution channels; and authorization and monitoring of clinical trials. With a regulatory system for vaccines assessed as functional by WHO, vaccine manufacturers in India continue to remain eligible to apply for prequalification of specific products. WHO prequalification, which is a guarantee that a specific vaccine meets international standards of quality, safety and efficacy, is a prerequisite for manufacturers to supply to countries through United Nations procuring agencies. "The Government of India has undertaken committed efforts to ensure that the regulatory oversight of the NRA for vaccines continues to meet international standards," said Dr David Wood, Coordinator of the Quality, Safety and Standards Team of the Department of Immunization, Vaccines and Biologicals of the World Health Organization. As for all NRA assessments, sustainability of the gains made in regulatory capacity is critical. For this purpose, the team which has just completed the assessment in India has drawn up a detailed Institutional Development Plan. The plan will outline additional activities to be undertaken to further strengthen regulatory capacity in India for the period 2013-2015. ]]> <![CDATA[Tata Memorial center and Piramal join hands for cancer research]]> https://biospectrumindia.com/news/95/3227/tata-memorial-center-and-piramal-join-hands-for-cancer-research.html https://biospectrumindia.com/news/95/3227/tata-memorial-center-and-piramal-join-hands-for-cancer-research.html Wed, 10 Apr 2013 17:43:00 +0530 Piramal Enterprises and Tata Memorial center have announced that they will collaborate to enable the development of valuable tools to better understand disease biology and predict responses to various treatments for cancer patients. The new alliance between the two organizations will focus on the development of preclinical cancer models to enhance the understanding of disease biology, treatment response/resistance and biomarkers as they relate to diagnosis, prognosis and response to drugs. These models will be based on tumor tissues from cancer patients and are predicted to have better translational relevance than the currently used human cancer cell line models. Scientists at TMC and PEL hope to gain a better understanding of the mechanisms through which various drugs work on different cancers. This research could lead to new therapies and predict the medicine best suited to treat an individual cancer patient. "Our collaboration with Piramal Enterprises addresses a critical need in cancer care, which is widely accessible and cost effective personalized medicine for cancer patients," said Dr Rajendra Badwe, MD, director of Tata Memorial Centre. Dr Swati Piramal, vice chairperson of Piramal Enterprises commenting on the development said, "We are excited to begin this collaboration with Tata Memorial Centre, which is India's leading centre associated with cancer treatment. We hope that the insights we gain from this alliance will ultimately lead to new treatment options for cancer patients." The New Chemical Entity (NCE) Research division of Piramal Enterprises focuses on the discovery and development of innovative medicines to improve the lives of patients suffering from cancer, diabetes, metabolic disorders and inflammatory conditions. It has a state-of-the-art research Centre in Mumbai and comprehensive capabilities spanning target identification all the way through clinical development. ]]> <![CDATA[Union Minister defends flexibilities in Indian IP regime]]> https://biospectrumindia.com/news/95/3226/union-minister-defends-flexibilities-in-indian-ip-regime.html https://biospectrumindia.com/news/95/3226/union-minister-defends-flexibilities-in-indian-ip-regime.html Wed, 10 Apr 2013 17:24:56 +0530 Close on the heels of the landmark judgment in the Novartis Glivec case, the Indian government has come out in support of an IP regime that considers socio-economic factors as well. Addressing a high level policy dialogue at the World Intellectual Property Organisation (WIPO) headquarters in Geneva today, the union minister for Commerce, Industry and Textiles, Mr. Sharma pointed out that the countries of the South which bear a disproportionate burden of poverty, hunger and disease for historical reasons have an aspiration to provide affordable healthcare solutions for their citizens. It is here that political leadership is faced with an ethical dilemma and tries to find creative solutions which would strike the right balance. Mr. Anand Sharma defended flexibilities for developing nations in honouring their international Intellectual Property (IP) commitment to meet their social challenges. He said, "It is my belief that while all countries are obligated to honour their international commitments, inherent flexibilities must be provided to developing countries to address these pressing social challenges," The Minister, who was speaking on "Innovation and Development: The Indian Experience" outlined the values that inform the Intellectual Property (IP) regime in India. The Minister maintained that the legislative regime in India which circumscribes the IP rights is a robust one and strikes a balance between the interests of the IP creators and the larger interests of the IP users. "It fosters technological innovation by providing inherent incentives through exclusive private Intellectual Property Rights, but also recognizes the need to protect the interest of users' rights," said the minister. This comes at a time when pharma MNCs are crying foul at the judgement for 'stifling innovation' with many voices in the industry stating that it will hurt R&D investments in India. The minister recounted the debate in 2005 that surrounded the harmonization of Indian IP with the TRIPS obligations. He talked of the divide on the two ends of spectrum especially in the pharmaceutical sector. On the one hand of the spectrum are companies who have invested billions in research, in developing new molecules, in new drug discoveries and in research. On the other hand is the compelling social need of providing affordable healthcare for all. Mr. Sharma strongly raised the issue of the intellectual property associated with genetic resources, traditional knowledge and folklore such as curative aspects of neem and haldi etc. Mentioning India's initiative of creating a unique digital library of traditional knowledge which has over 250,000 entries highlighting the source and the efficacy of each product, Shri Sharma expressed concern about the fact that at times there is extensive bio-piracy through patents being awarded for traditional knowledge. "India has been at the forefront for bringing this agenda on the negotiating table and for the last one decade, we have been trying to build a consensus for a binding treaty on traditional knowledge. I hope that WIPO shall be able to bring these negotiations to culmination," said the Minister. Another important development was Mr. Sharma handing over the instrument of Accession to the Madrid Protocol. This is a significant step in the evolution of India's Intellectual Property Regime which has seen a gradual progression in line with international agreements over the years. This instrumentality will provide an opportunity for Indian companies, who are increasing their global footprint, enabling them to register trademarks in member countries of the protocol through a single application, while also allowing foreign companies a similar disposition in India. This will considerably help in simplification and easing the process of trade mark registrations in India. ]]> <![CDATA[eHealth Access conducts telemedicine pilot in Gujarat]]> https://biospectrumindia.com/news/95/7511/ehealth-access-conducts-telemedicine-pilot-in-gujarat.html https://biospectrumindia.com/news/95/7511/ehealth-access-conducts-telemedicine-pilot-in-gujarat.html Wed, 10 Apr 2013 16:21:00 +0530 eHealth Access recently conducted a medical camp in the Dang district of Gujarat. The medical camp was a pilot test which offered free consultations with doctors via the recently launched Medical Kiosk by eHealth Access.The two day pilot started with Gujarat Dang district where 128 consultations (65 percent females and 35 percent males) were conducted successfully. Commenting on the event, Mr Suchindra, IFS officer from Dang district, Gujarat, said, "eHealth Access has developed a very useful model; The innovative Medical kiosk technology will help tribal villages to have effective primary and preventive healthcare and this has proved to be working." The Medical Kiosk developed by eHealth Access is a portable plug and play device that enhances the doctor reach by enabling new paths for doctor consultations to support patient with their primary health needs. Doctors can now reach the patients regardless of geographical boundaries through the Medical Kiosk. "This is a boon to rural India and can be a means to make Government of India's Universal Health Program a reality, where we can reduce the doctors to Patient gap and make "doctor-reach" a reality for the common and underserved population, thereby aiding in the process of making India Healthy." said, Mr Ram Prabhu, technology director, eHealth Access. "We started the pilot test in Gujarat and are planning replicate this activity PAN India." The latest census of health sector shows that India is lagging behind in doctor-patient ratio. It is observed, at present, that there is only one doctor available for more than 1,900 patients. Experts believe that in-order to reach an ideal doctor-patient ratio a standard, India has to wait till 2050. The technology built in the Kiosk, allowed assessing patient's profile on BP, Sugar, ECG, temperature and BMI to be transferred to the doctor instantaneously, at the health camp. After the diagnosis, people got their respective prescriptions printed on the local printer. People also brought in their previous medical reports for second opinion and they were able to scan it in the Medical Kiosk to send it to the Doctor and could successfully get the doctor's response through video consultation. "I'm pleased with the technology in the device; it is almost like real time experience and makes it possible to see all of the patient vitals, patient over web, and investigation in electronic form," said Dr Rikin Patel, a medical practitioner from Gujarat who participated in the health camp. The free medical camp was supported by Working Brains who are distributors of the Medical Kiosk. ehealth Access is an innovative health care company, is focused on developing a new health care ecosystem through advanced telemedicine technology. The company through its website provides healthcare services over internet and through phone. ]]> <![CDATA[Dr Reddy's moves N.America headquarters to Princeton]]> https://biospectrumindia.com/news/95/6452/dr-reddys-moves-n-america-headquarters-to-princeton.html https://biospectrumindia.com/news/95/6452/dr-reddys-moves-n-america-headquarters-to-princeton.html Wed, 10 Apr 2013 13:39:00 +0530 Dr Reddy's Laboratories recently announced plans to relocate their North America headquarters and establish a R&D Center in Princeton, New Jersey. The new North America headquarters will house the generics, biologics, PSAI and proprietary product businesses as well as the corporate support functions within North America. It is projected to employ more than 300 people as the US businesses within Dr Reddy's continue to expand in the coming years. Commenting on the move, Mr GV Prasad, chairman and CEO, Dr Reddy's said, "The relocation will allow Dr Reddy's to tap into local talent which will be instrumental in our long term growth. This R&D center, along with centers in Cambridge (UK) and Leiden (Netherlands) establishes our presence within some of the leading innovation centers of the world." Dr Reddy's entered into two lease agreements for a two separate facilities. Dr Reddy's anticipates relocation to the one of the office facilities by the end of the summer of 2013 after the renovations to the facility are completed. The other lab facility located at 303 College Road East will undergo a redesign to accommodate Dr Reddy's product development and analytical laboratory requirements. The lab facility is also expected to be completed by late summer to early fall of 2013 and will employ 35 scientists, chemists and support personnel. ]]> <![CDATA[Govt extends deadline for pharma barcode adoption]]> https://biospectrumindia.com/news/95/5252/govt-extends-deadline-for-pharma-barcode-adoption.html https://biospectrumindia.com/news/95/5252/govt-extends-deadline-for-pharma-barcode-adoption.html Wed, 10 Apr 2013 11:31:00 +0530 The Ministry of Commerce has extended the deadline to fix bar codes on primary level packaging by pharma companies to July 1, 2014. Exporters were to implement bar codes on primary level packaging with effect from July 1, 2013 which has now been deferred. "Earlier, the requirement of affixing barcodes on primary level packaging was to take effect from July 1, 2013. Now this date has been deferred to July 1, 2014," the Directorate-General of Foreign Trade (DGFT) said in a public notice. A barcode helps in tracking and tracing of origin of drugs, which in turn helps in minimising the chances of genuine drugs being considered spurious, sub-standard or counterfeit. Primary level packaging is the first-level product packaging such as the bottle, can, jar, tube, that contains the item sold. ]]> <![CDATA[Why Indian vaccine industry should innovate?]]> https://biospectrumindia.com/features/95/5199/why-indian-vaccine-industry-should-innovate.html https://biospectrumindia.com/features/95/5199/why-indian-vaccine-industry-should-innovate.html Tue, 09 Apr 2013 17:45:50 +0530 In the past few years, close on the lines of Indian pharma, which is investing heavily in novel drugs or better generics, the vaccine industry has been making concerted efforts to develop vaccines on not just tropical neglected diseases, but also affordable versions of vaccines already available in the West. The recently organized Vaccine World Summit 2013 in Pune proved to be a melting pot of not just the vaccine industry, but also clinicians, regulators, funding agencies and research scientists. What set apart the large number of foreign agencies looking to partner with Indian companies was the fact that a majority of them were for early stage technology platforms involved in the development of vaccines. Dr Suresh Jadhav, executive director, Serum Institute of India, very simply put the importance of Indian companies in context when he said, "75-80 percent of vaccines developed and procured by UN agencies are from the developing world and almost 80 percent of these are from India." Estimates for the entire industry have ranged from $260 million according to Dr TS Rao, Adviser, Department of Biotechnology (DBT) to $500 million as stated in a report by consultancy firm McKinsey. These facts only serve to reinstate the overall belief that the impact of the Indian vaccine industry on immunization around the world is undeniable, and will continue to be fundamental in the days for providing affordable quality vaccines to the world. New vaccines on the horizonThe Rotavirus vaccine, a mammoth Public-Private Partnership (PPP) involving DBT, Gates Foundation, Program for Appropriate Technologies in Health (PATH), Centers for Disease Control, USA, National Institutes of Health-National Institute of Allergy and Infectious Diseases (NIAID), USA, Society for Applied Studies, Translational Health Sciences Technology Institute, Indian Institute of Science, All India Institute of Medical Science, and Stanford University recently completed its Phase III trials in February 2013. These were conducted on 6800 subjects at three locations; SAS Delhi, CMC Vellore, and KEM Mumbai with the data currently being analyzed. Dr Krishna Ella, chairman and MD, Bharat Biotech had earlier announced that this vaccine would be made available at $1 only. This has been the case with most ventures with a majority of the vaccines currently under development, a result of partnerships. One of those is Novavax and Cadila Pharmaceuticals, whose joint venture, CPL Biologics was created in 2009 to harness the innovation potential of a small biotech like Novavax and the advantage of scale and experience of Cadila Pharmaceuticals. Dr Sudeep Srivastava, Vice President, Biotech Manufacturing, Cadila Pharmaceutiacals, speaks of the progress made so far, "Moving ahead we have a very strong focus on developing vaccines using Novavax's platform technology. We have already completed Phase I and Phase II trials for a seasonal flu and a pandemic flu vaccine, based on based on Novavax's virus-like-particle (VLP) vaccine technology. Additionally,we are also in the midst of developing a rabies vaccine." Indian companies are leading the way, when it comes to neglected diseases. Panacea Biotec is also in the early stages of development of a tetravalent dengue vaccine. Indian Immunologicals has also been pooling its efforts in developing vaccines for neglected tropical diseases such as chikungunya and kala azar. They are also concentrating efforts on an oral cervical cancer vaccine, a first from the developing world, thus alluding to its affordability for the masses. The DBT is closely monitoring the development of a cholera vaccine that is in Phase III trials. Malaria is another challenge that Indian companies have taken up in the recent past. A vaccine developed by ICGEB (International Centre for Genetic Engineering and Biotechnology) was initiated into clinical trials in late 2011, a project in which Bharat Biotech had manufactured the vaccine. Gennova Biopharmaceuticals too has been an active participant in the development of a malaria vaccine. Dr Sanjay Singh, CEO, Gennova Biopharmaceuticals says, "We have multiple projects targeting the different stages of the life cycle of the malarial parasite. The first candidate from Gennova will head for clinical trials soon. Another project initiated a year and a half back is studying people that have shown a natural immunity to the malarial parasite. By analyzing the monoclonal antibodies isolated from this population, we hope to gain further understanding in this field". The launch of Biological E's indigenously developed Japanese Encephalitis vaccine too was the result of years of hard work as well as a successful collaboration with Intercell, a Vienna-based company who had done the early development work for the same vaccine. Polio's success storyWith sustained efforts from all quarters of society across the globe, we are now close to making polio, only the third infectious disease to be eliminated completely, after small pox and rinderpest. The Indian vaccine industry has played a major role in this initiative and continues to as well. As reported earlier in BioSpectrum, Panacea Biotec has been a major supplier of OPV (Oral Polio Vaccine). Recently after staying away from the crowded space of OPV suppliers in India, Serum Institute of India (SII) also finally joined the pack, by starting the production of its brand of the vaccine. While admitting that SII is a late entrant into this space, Dr Jadhav said that other events led them to take this step. "Since the supply from two other Indian suppliers for the OPV had to be stopped due to some regulatory issues, the UN agencies were facing a shortage of vaccines. We were then asked by the UN agencies to address this issue, and we have now risen to fill in the shortfall." With no live case being reported in over two years in India, the OPV program will soon be phased out. Dr Jacob John, advisor, WHO committee on Global Polio Eradication and virologist at CMC, Vellore, and a renowned authority on the polio eradication effort in India explained the current scenario at length by saying, "Studies have shown that continued use of OPV will give rise to cases of Vaccine Derived Polio Virus, such as those that are emerging in some areas of Afghanistan. The strategic plan for 2013-2018 has already been drawn out. The general idea is that there will be a universal introduction of the IPV after 2015, along with a synchronized removal of OPV." Currently one of the main challenges to using Injectible Polio Vaccine (IPV) is its cost which is approximately $2.66 per dose, as compared to $0.14 for OPV. Industry experts suggest that OPV production will not be stopped completely, but rather given along with IPV in a one out of three doses or one out of two dose scheme, in the beginning of the new effort. A number of manufacturers worldwide are working towards reducing the cost of a single dose of IPV to less than a dollar, so that the transition is smooth and simultaneous around the world without cost being a barrier. At the same event, while receiving Lifetime Achievement Award for his contributions, Dr Cyrus Poonawalla, chairman, SII commented that SII would try to offer its own brand of IPV at $0.93 per dose. The eventual introduction of IPV into the Universal Immunization Programme could also herald the popularity of hexavalent vaccines, something which a number of Indian companies including Shantha Biotechnics are working on. Global MNC, GSK (GlaxoSmithKline) recently initiated a joint venture with Hyderabad based Biological E for a hexavalent vaccine development for the developing world. This 50-50 joint venture will be focused on early stage R&D and will utilize GSK's brand of IPV. Biological E has already been one of the largest suppliers of DPT (Diptheria Pertussis and Tetanus) vaccines to the Indian government for their immunization programs. The amazing work set aside, the dearth of a single window clearance was cited as one of the major challenges to the vaccine industry in India. The continued delays in procuring permission for trials has affected not only companies but also medical professionals who conduct trials for gaining a better understanding of the need and effect of vaccines for the Indian population. Mr Sai Prasad, vice president, business development, Bharat Biotech said, "The development of vaccines involves not one, but a number of government agencies. There are processes which need to be streamlined for developing newer vaccines so that simple yet important things such as importing specific cell lines is doable within a defined time limit." Dr TS Rao, also commented on the same, by saying, "We realize that one of the challenges in the vaccine space is clinical trials of new vaccines. DBT is closely working with DCGI to solve this issue regarding clinical trials." This has prompted all the major vaccine manufacturers in India to form a Developing Vaccine Manufacturers Network. This industry body is currently in the process of assimilating the necessary demands of the vaccine industry as a collective and not an individual company and then present it to various agencies such as Department of Biotechnology, Ministry of Health and Family Welfare and Indian Council of Medical Research and such. However a lot remains to be done. Mr Ranga Iyer, advisor, India Health Progress says that despite the amazing progress by Indian individuals, "Two million vaccine preventable deaths still occur in India. India has huge capacities for vaccine production, with over 70 percent vaccines manufactured in India being exported, the per capita spend for vaccines for the Indian population is estimated to be US$0.01. When the pentavalent vaccines was included in the UIP last year the original plan was to expand it to other states, however, till date it remains restricted to the two states of Kerala and Tamil Nadu." With an amazing pipeline in store, the next five years could put Indian manufacturers on the innovation map. For now, it would appear that the Indian population to reap the benefits of these efforts however will take a lot more than just technical ingenuity. ]]> <![CDATA[Yet another panel to probe CDSCO functioning ]]> https://biospectrumindia.com/news/95/3191/yet-another-panel-to-probe-cdsco-functioning-.html https://biospectrumindia.com/news/95/3191/yet-another-panel-to-probe-cdsco-functioning-.html Tue, 09 Apr 2013 17:24:00 +0530 The union health ministry has constituted a committee to review the procedure and practices followed by the Central Drugs Standard Control Organization (CDSCO) for granting marketing approval and clinical trials in cases. The four-member expert committee, headed by Prof. T M Mahapatra, former director of Institute of Medical Sciences, Banaras Hindu University, will examine the procedures and practices followed in granting approvals in fixed dose combination of aceclofenac with drotaverine, buclizine, letrozole and placenta extract. The committee will see if scientific requirements and the regulatory compliance were adhered while giving permissions. Other three members include Prof. Satyawan Singh, former scientist at CDRI and Mr Venkat Krishnan, former drug controller of Kerala, and a representative of the chief vigilance officer in the health ministry. The possible reason behind the decision is that the earlier committee headed by Dr V M Katoch, director general, Indian Council for Medical research (ICMR), constituted by the health ministry last year, didn't fix any responsibilities on wrong doings at CDSCO in its report. Apart from that, the government has taken into consideration the critical remarks made in the 59th report by the Parliamentary Standing Committee on the functioning of CDSCO. ]]> <![CDATA[Genzyme India, SIAMG join hands to train doctors in clinical genetics]]> https://biospectrumindia.com/news/95/3012/genzyme-india-siamg-join-hands-to-train-doctors-in-clinical-genetics.html https://biospectrumindia.com/news/95/3012/genzyme-india-siamg-join-hands-to-train-doctors-in-clinical-genetics.html Mon, 08 Apr 2013 17:05:00 +0530 To promote the science and practice of clinical genetics in India, Genzyme, one of the world's foremost biotechnology companies and now a part of Sanofi worldwide on April 8, 2013, announced a tie-up with the Society for Indian Academy of Medical Genetics (SIAMG) for a joint fellowship program for Indian medical professionals. This program, which is of three months duration will be organized at the Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow and the first batch is set to begin from July this year. The MOU was signed at New Delhi by SIAMG president, Dr Shubha R Phadke and Mr Sandeep Sahney, head of Genzyme for India and South Asia. Under the terms of the agreement, Genzyme India will provide support to IAMG to help spread awareness about medical genetics in the country. The three-month fellowship program will be supported by Continuous Medical Education (CME) and medical workshops at the local as well as national level. IAMG, with the support of Genzyme, will also be bringing out a quarterly newsletter on genetics under the title of "Genetic Clinics." Commenting on the agreement, Dr Shubha R Phadke said, "We are very pleased to collaborate with Genzyme India to promote clinical genetics in the country. This partnership will have a significant impact on the newly-emerging field of genetic research and help strengthen India's biotechnology capabilities to make a difference to the lives of the Indian people." On the same occasion, Mr Sandeep Sahney highlighted that this important agreement as one more example of demonstrating Genzyme's commitment to India. He said, "We are confident that these fellowships in clinical genetics will act as a catalyst for promoting academic excellence and applied research in this discipline in India as well as build clinical expertise." ]]> <![CDATA[Repeat testing of GM crops must stop : ABLE AG ]]> https://biospectrumindia.com/news/95/3014/repeat-testing-of-gm-crops-must-stop-able-ag-.html https://biospectrumindia.com/news/95/3014/repeat-testing-of-gm-crops-must-stop-able-ag-.html Mon, 08 Apr 2013 15:46:00 +0530 "Our immediate concern is to get permission for states to conduct GM crop research trials. That includes No Objection Certificates (NOCs) for biosafety level 1 and 2 trials as already approved by Genetic Engineering Appraisal committee (GEAC) in the past, and those likely to be permitted based on last month's GEAC meeting, the minutes of which are being is eagerly awaited. In this connection, we have already started contacting state governments all over again. Thus, one of the major concerns of the industry is to seek permission for testing GM crop cultivars without losing much time: already two precious years have been lost, which translates into enormous cost to the industry, and a much larger opportunity cost to the country," stated Dr N Seetharama, executive director of Association of Biotechnology led Enterprises-Agriculture Group (ABLE-AG), who spoke to BioSpectrum over telephone on April 6, 2013. ABLE-AG consists of 12 member companies that are considered to be leading technology providers of modern agricultural biotechnology to the country. The industry association been trying to persuade the state governments for not to go for the repeat testing of GM crops slated for trials. Dr Seetharama added further, "We are holding meetings with the principal secretaries of various state governments to make them realize that the laboratory testing by state government is not required when that has already happened once at the central level." "At present, we all know that the regulatory structure is very complex and we have to bear with the same system for the time being. However, I am equally hopeful that government will put the resolution of the issue on fast tract mode. We hope that the pending Biotechnology Regulatory Authority Bill (BRAI) would be soon tabled in the parliament and the new better regulatory system will replace this existing one," concluded Dr Seetharama. ]]> <![CDATA[St. Jude Medical launcehs ILUMIEN system in India ]]> https://biospectrumindia.com/news/95/3214/st-jude-medical-launcehs-ilumien-system-in-india-.html https://biospectrumindia.com/news/95/3214/st-jude-medical-launcehs-ilumien-system-in-india-.html Fri, 05 Apr 2013 17:18:54 +0530 St. Jude Medical, Inc., a global medical device company, has launched ILUMIEN PCI Optimization System as a treatment option for patients suffering from coronary artery disease (CAD) in India. The ILUMIEN system is an integrated diagnostic technology that combines optical coherence tomography (OCT) and fractional flow reserve (FFR) technologies together in one platform helping physicians better identify and make treatment decisions for blood flow blockages in the heart. The ILUMIEN System allows for a customized plan unique to each patient, using the most beneficial treatment options that can range from medication, stenting or surgery, or a combination of therapies. With the integration of FFR and OCT technologies, physicians can identify the precise measurement and dimensions of culprit artery narrowings responsible for obstructing blood flow to a patient's heart, as well as determine vessel size and structure. The ILUMIEN PCI Optimization System received U.S. Food and Drug Administration (FDA) and European CE Mark approval in 2011. "The ILUMIEN system combines two powerful tools to help physicians decide on the best treatment strategy for patients with coronary artery disease," said Mr Kaustav Banerjee, country manager for St. Jude Medical India. "St. Jude Medical is dedicated to providing Indian physicians with advanced technologies that help them efficiently and effectively diagnose and treat patients." The Madras Medical Mission hospital located in Chennai was the first center to use the ILUMIEN System in India to create a treatment plan for patients with CAD. Using the ILUMIEN System, physicians gain advanced physiological and anatomical insights to improve the diagnosis and treatment of CAD. "The key to treating coronary artery disease is by knowing which blockage or blockages need treatment, and understanding how to best treat them," said Dr. Mullasari Ajit Sankardas, director of cardiology at Madras Medical Mission. "The ILUMIEN system provides me with this critical information about the severity and location of blood flow blocks in one place to create a personalized treatment plan for each patient." ]]> <![CDATA[DBT and Gates Foundation launch Grand Challenges India]]> https://biospectrumindia.com/news/95/3213/dbt-and-gates-foundation-launch-grand-challenges-india.html https://biospectrumindia.com/news/95/3213/dbt-and-gates-foundation-launch-grand-challenges-india.html Fri, 05 Apr 2013 16:17:00 +0530 Recently, the Department of Biotechnology (DBT), Biotechnology Industry Research Assistance Council (BIRAC), and the Bill & Melinda Gates Foundation launched Grand Challenges India. Through this partnership, the government and the foundation will co-fund projects that aim to harness Indian innovation and research, and direct scientific discovery to develop affordable, sustainable solutions that improve health in India and around the world. The program was formally launched late last month. Commenting on the development, Steven Buchsbaum, Deputy Director on the Discovery & Translational Sciences team at the Bill & Melinda Gates Foundation said, "We are proud to partner with BIRAC because we believe India is uniquely positioned to be a global leader in the development of new technologies and innovative approaches to achieve sustainable gains in development and health. Under the Memorandum of Understanding that was signed last year, the DBT and the Gates Foundation have agreed to invest up to $ 25 Million each over 5 years in innovations in vaccines, drugs, agricultural products, and interventions related to malnutrition, family and child health." DBT and BIRAC join a global network of partners already using the Grand Challenges framework to foster collaborative research to improve global health and development. The Bill & Melinda Gates Foundation recognizes that solving our greatest global health and development issues is a long-term effort. Through Grand Challenges, the foundation along with other Grand Challenges partners such as USAID, Grand Challenges Canada, and Grand Challenges Brazil, are committed to seeking out and rewarding not only established researchers in science and technology, but also young investigators, entrepreneurs, and other innovators to help expand the pipeline of ideas to fight diseases that claim millions of lives each year. ]]> <![CDATA[India calls for scaling up response to non-communicable diseases]]> https://biospectrumindia.com/news/95/3211/india-calls-for-scaling-up-response-to-non-communicable-diseases.html https://biospectrumindia.com/news/95/3211/india-calls-for-scaling-up-response-to-non-communicable-diseases.html Fri, 05 Apr 2013 15:23:00 +0530 Addressing the inaugural programme of the national conference organised by the ministry of health and family welfare and the world health organization (WHO) to celebrate World Health Day 2013, Keshav Desiraju said the prevalence of NCDs such as cardiovascular disease, diabetes, chronic obstructive pulmonary disease, and cancers is increasing.High blood pressure is a leading risk factor for cardiovascular disease; in 2008, 24% of all deaths in India were from cardiovascular diseases. He stressed the need to address the major risk factors such as unhealthy diet, physical inactivity, tobacco intake, harmful use of alcohol by creating awareness on promotion of healthy lifestyle and habits among the community. He urged for a stronger focus on high blood pressure, the theme of the World Health Day 2013 as part of a comprehensive approach to NCDs. He revealed that the Government plans to scale up the response to the NCDs epidemic by expanding the National Programme for Prevention and Control of Cancer, Diabetes, Cardiovascular Diseases and Stroke (NPCDCS) from 100 districts at present to cover all districts in the country during the 12th Five Year Plan. He also spoke about the steps taken by the Government of India for early detection of diabetes and blood pressure. Under the NPCDCS, about 1.76 crores persons aged 30 years and above have been screened for diabetes and hypertension, out of which 7.22% were suspected of having diabetes and 6.59% hypertension. Highlighting the reasons for choosing 'High Blood Pressure' as the theme for World Health Day 2013, Dr. Nata Menabde, WHO Representative to India said "High blood pressure affects one in three adults worldwide and leads to more than nine million deaths globally every year. Many people do not even know they suffer from high blood pressure." Dr. Menabde stressed the need for action at the community level for prevention and control of this silent killer. She further stated that in many countries, including India, the out-of-pocket expenditure incurred on NCDs is high, contributing to the impoverishment of households and hitting the poor the worst. She also added that medicines for these chronic diseases account for a large portion of expenditure. Addressing the programme, Dr. Jagdish Prasad, director general of health services said that it is essential to address NCDs (including high blood pressure) in health system strengthening efforts for universal health coverage. Speakers at the conference emphasized the need to ensure an environment conducive to healthy lifestyles, in which it is easier for all people to make choices that promote their health. Such an environment reduces exposure to the risk factors for NCDs, such as tobacco use, unhealthy diets, harmful use of alcohol and insufficient physical activity. Coordination between the health sector, food and agriculture sector and other relevant stakeholders for the reduction of salt intake in food was cited as one of the best buys for the reduction of hypertension and related cardiovascular diseases. It may be mentioned that the Government of India has been a key player in WHO processes towards the production of draft global and regional action plans for 2013-2020 to address NCDs, as well as the creation of a draft global monitoring framework for the prevention and control of NCDs. The monitoring framework has the overarching goal of a 25% reduction in premature mortality from NCDs by 2025. All countries are being encouraged by WHO to create national monitoring frameworks, drawing from the global one, which is expected to be approved by the World Health Assembly in May 2013. ]]> <![CDATA[GM is not the final solution: Dr Brahmachari ]]> https://biospectrumindia.com/news/95/3208/gm-is-not-the-final-solution-dr-brahmachari-.html https://biospectrumindia.com/news/95/3208/gm-is-not-the-final-solution-dr-brahmachari-.html Fri, 05 Apr 2013 12:45:00 +0530 "The CSIR is looking forward to lot many activities in the year 2013. In the 12th plan (2012-17), about Rs 800 crore has been earmarked for only catering to generic activities. Apart from that close to Rs 4,000 crore has been allocated for the research. The Institute of fourth paradigm, bioinformatics data centre is also being established. Apart from that we are starting an institute of synthetic biology at Ghaziabad in national capital region (NCR)." This was stated by Dr Samir K Brahmachari, director general CSIR while speaking to BioSpectrum recently. However, Dr Brahmachari doesn't seem to be convinced about the use of genetically modified plants on priority basis.. He says, "Why are we only harping on GM. Infact, there are many areas where the matrix associates selection (MAS) technique has to be utilized in the future. The GM focus must be only on relevant crops if necessary. Our top priority has to protect biodiversity and hence focus on documentation of all the species must be the priority." Speaking further on the issue, he added, "I was looking at Rajma. How many varieties of Rajma we have in India? There is a possibilities that we may find the drought resistant varieties in the remote areas. So we need to do lot more activity on understanding and documenting biodiversity. One has to know that I cannot carry out monoculture in Chattisgarh that might be popular in America or else forestry will die. Some people think nature is stupid and try to play around. Is it possible to screen intelligent people at embryo level and take them only and discard others? Then we will have only people of our liking! But where will it lead us to? I think its better we concentrate on right kind of activities rather than making GM a priority." On being asked about his talk on pharmacogenomics recently at National Institute of Immunology, New Delhi, Dr Brahmachari mentioned, "The repositioning of the same drug is also that we are looking at. There is a lot of opportunity and we can do a lot in cancer drugs. We should be able to use pharmacogenomics in identifying the drug combinations. The best thing is that these will have least side effects possible with highest therapeutic value." ]]> <![CDATA[Health research gets a major push in 12th plan]]> https://biospectrumindia.com/news/95/3122/health-research-gets-a-major-push-in-12th-plan.html https://biospectrumindia.com/news/95/3122/health-research-gets-a-major-push-in-12th-plan.html Thu, 04 Apr 2013 14:45:00 +0530 Spearheading the key initiatives in health research, the DHR and ICMR have been boosted with doubled budget allocation for the implementation of various schemes and research initiatives in the next five years. These premier medical research agencies have played a significant role in development of indigenous reagents for H1N1, indigenous vaccines for H1N1, reagents/tests for Japanese Encephalitis, dengue etc. During the last five years, altogether 20 virology laboratories have been upgraded and 16 new laboratories including 14 bio safety laboratory II level and 2 bio safety III level established for working on viral diseases and TB. As per the release issued by the health ministry on achievements made in last five years, the Asia's first bio safety IV level laboratory has been established in 2012 at National Institute of Virology, Pune in collaboration with the Department of Science and Technology (DST). The laboratory has started working on 75 leads of potential public health importance for development and evaluation of affordable diagnostics including indigenously developed tests for diabetes, diagnostic test for TB and several other infections and cancer. Work on 30 such technologies will be completed during 2013-14. Major focus on infrastructure development The National Research and Environment Health (NREH) was established at Bhopal as 31st institute of ICMR. The institute will focus on long term effects of MIC exposure, health hazards due to chemical exposures and environmental pollution.Bhopal Memorial Hospital and Research Centre has been taken over by ICMR. National Centre for Diseases Informatics and Research was established at Bangalore to develop and sustain a national research data base on cancer, diabetes, CVD and stroke by using information technology for national collaborative network. New field stations of ICMR Institutes were established at Car Nicobar, Nancowry (Andaman & Nicobar Islands), Gorakhpur (UP), Alappuzha (Kerala) Rayagada and Kalahandi (Odisha) and Guwahati (Assam) to serve the health problems of the local communities. A National Clinical Trials Registry in India, an online system for registration of all clinical trials, has been established to improve transparency, accountability and accessibility in order to re-establish public trust in clinical trial data. Upcoming research and policy initiatives In order to meet the shortfall in its healthcare spending, the amount of Rs 10,000 crore has been earmarked for the Department of Health Research and Indian Council for Medical Research (ICMR) during 12th five year plan (2012-2017) as against about Rs 4400 crore in 11th plan. Multi-disciplinary research units are proposed to be set up in all 150 government medical colleges at a cost of Rs.1118 crore to have a dedicated infrastructure for research in medical colleges. More than 50 proposals have been received from 20 states so far. A network of viral and other infectious disease diagnostic research laboratories will be set up for handling viral diseases like TB etc. 200 district level medical labs and 48 state level labs and 6 regional labs are proposed to be established during 12th Plan at a cost of Rs.1084 crore.A new scheme is being launched to train mid-career medical teachers and scientists to develop human resource in cutting edge areas of medical and health research. 3000 students and researchers are expected to be benefited by these fellowships. Among the guidelines that have been developed are the prevention, management and control of reproductive tract infections including sexually transmitted infections, management of diabetes, management of three type of cancers (oral, buccal and stomach), revised nutritional guidelines. Also the guidelines on genetically modified foods and probiotics were released. The policies in pipeline include the bill on assisted reproductive technology, a bill on recognition of alternate systems of medicine, bill on biomedical research on human participants, knowledge management policy and e-governance, national health research policy and accreditation of health research institutes. ]]> <![CDATA[Dr.Reddys launches osteoporosis generic ]]> https://biospectrumindia.com/news/95/3075/dr-reddys-launches-osteoporosis-generic-.html https://biospectrumindia.com/news/95/3075/dr-reddys-launches-osteoporosis-generic-.html Thu, 04 Apr 2013 14:38:03 +0530 Dr. Reddy's Laboratories announced today that it has launched Zoledronic Acid Injection , a therapeutic equivalent generic version of Reclast (zoledronic acid) injection in the US market. This was following approval by the United States Food and Drug Administration (USFDA) of Dr. Reddy's ANDA for Zoledronic Acid Injection (5 mg/100 mL). The Reclast brand had total U.S. sales of approximately $355 million for the most recent twelve months ending February 2013 according to IMS Health.Reclast is indicated for treatment of osteoporosis in postmenopausal women. In postmenopausal women with osteoporosis,diagnosed by bone mineral density (BMD) or prevalent vertebral fracture, Reclast reduces the incidence of fractures (hip,vertebral and non-vertebral osteoporosis-related fractures) Dr. Reddy's Zoledronic Acid Injection (5 mg/100 mL) is available in a single use vial for Intravenous Infusion. ]]> <![CDATA[OSDD crosses 7000 members mark ]]> https://biospectrumindia.com/news/95/3001/osdd-crosses-7000-members-mark-.html https://biospectrumindia.com/news/95/3001/osdd-crosses-7000-members-mark-.html Thu, 04 Apr 2013 11:30:00 +0530 The members of OSDD community must be happy to know that the total community members who have registered on Sysborg is now 7074 from 130 countries.The increasing numbers as per the team heading the initiative shows wide acceptance of OSDD across nations.They feel that the active and serious scientific discussions on Sysborg reflects the seriousness of the community in realizing the vision of OSDD. In his recent interaction with the BioSpectrum, Dr Samir K Brahmachari, director general, CSIR and chief mentor, OSDD, said, "According to me affordable healthcare is a right for all. And the OSDD has been doing an outstanding job and infact a best example where India has taken a lead in engaging the researchers across world to share their knowledge and insights. I feel that it will surely lead to product development in some crucial disease that demand attention. The best part is that it is a barrier free innovation that will bear fruits for downtrodden of the society. " The core funding of OSDD is from the government of India. For the period of September 2008 to March 2012 Government of India has earmarked Rs 45.96 Crores (about $12 million) for the project. The funds are used for funding the scientific projects, setting up infrastructure, and supporting ongoing activities of the project. OSDD led by Council of Scientific and Industrial Research (CSIR), is a concept to collaboratively aggregate the biological, genetic and chemical information available to scientists in order to use it to hasten the discovery of drugs. This will provide a unique opportunity for scientists, doctors, technocrats, students and others with diverse expertise to work for a common cause. The consortium with global partnership with a vision to provide affordable healthcare to the developing world by providing a global platform where the best minds can collaborate and collectively endeavor to solve the complex problems associated with discovering novel therapies for neglected tropical diseases like Malaria, Tuberculosis, Leshmaniasis, etc.OSDD is a translational platform for drug discovery, bringing together informaticians, wet lab scientists, contract research organizations, clinicians, hospitals and others who are willing to adhere to the affordable healthcare philosophy. ]]> <![CDATA[Health situation not best but we are not giving up either says Azad ]]> https://biospectrumindia.com/news/95/1383/health-situation-not-best-but-we-are-not-giving-up-either-says-azad-.html https://biospectrumindia.com/news/95/1383/health-situation-not-best-but-we-are-not-giving-up-either-says-azad-.html Wed, 03 Apr 2013 13:35:00 +0530 Addressing the first Indira Gandhi Oration instituted in memory of former prime minister, Indira Gandhi at the North Eastern Indira Gandhi Regional Institute of Health and Medical Sciences (NEIGRIHMS), Shillong on April 02, 2013, Ghulam Nabi Azad said,"We are dealing with a complex health environment, persistent communicable diseases, increasing non-communicable diseases and emerging infections in our country. The last four years have been historic times for the Indian Healthcare in terms of not only several reforms have been brought in all aspects of health-care delivery systems but also concrete achievements appreciated the world over." Azad said India has earned international acclaim for containing polio, with the longest polio-free period ever since eradication efforts were launched. India has been taken off the list of countries with endemic transmission of wild poliovirus. There have been significant reduction in new HIV cases by 57%. Speaking further on Universal Immunization Programme (UIP), he said, "Hepatitis-B vaccine has been included in the UIP. Japanese Encephalitis vaccination is now being undertaken in 175 identified districts, with 62 new districts being added to the existing 113 in 19 states. Pentavalent Vaccine containing DPT, Hepatitis-B and Hib vaccines was started in two states of Kerala and Tamil Nadu from December 2011.Six more states i.e., Haryana, Goa, J&K, Karnataka, Gujarat and Puducherry were included in December, 2012 for expansion of the programme." "To overcome the shortage of healthcare executives, government of India has sanctioned 269 nursing schools in the last two years, mostly in remote, inaccessible and under-served districts. With an estimated outlay of Rs. 2,030 crores, these institutions will give about 20,000 additional nurses annually. To give a boost to para-medical education and scale up the availability of para-medics, a National Institute of Paramedical Sciences (NIPS) at Delhi and 8 Regional Institutes are being established. A total of 10,760 paramedic professionals are expected to be trained annually when these institutes of excellence are fully functional", informed the minister. ]]> <![CDATA[ICMR to facilitate commercial human biomaterial transfer]]> https://biospectrumindia.com/news/95/1260/icmr-to-facilitate-commercial-human-biomaterial-transfer.html https://biospectrumindia.com/news/95/1260/icmr-to-facilitate-commercial-human-biomaterial-transfer.html Wed, 03 Apr 2013 10:51:00 +0530 As per the guidelines issued by the ministry of health and family welfare, government of India, of India dated November 19, 1997, a committee has been constituted by director general (DG), Indian Council of Medical Research (ICMR) to consider the cases related to transfer of human biological material for commercial purposes. This will be a continuous process and ICMR will process the applications four times in a year. The future deadlines for submission of applications would be last date of January, April, July and October in each calendar year. The evaluation of cases where infectious biological material/samples are proposed to be transferred from foreign research centers to Indian diagnostic laboratories/research centers or vice versa for analysis; transfer of human biological waste material or any other cases for commercial purposes will be considered by this committee. Ten sets of the application including copies of the following documents are required to be submitted by the applicants to ICMR. A copy of the duly signed Material Transfer Agreement (MTA) along with a copy of Institutional/Independent Ethics Committee (IEC) clearance along with the composition of Ethics committee. A copy of the Informed consent/undertaking of individual patient(s) agreeing to the utilization of said biological samples for a particular study/purpose. The undertaking should also clearly state that the patient is willing /not willing (as agreeable to patient) to claim any commercial benefit on the product developed as a result of work carried out on his/her biological samples. The applicants have to also submit a copy of the import certificate as issued by the relevant foreign regulatory authority to the foreign laboratory receiving the Indian biological samples. A copy of the Memorandum of Understanding signed between Indian laboratory and international agency defining the commercial benefits to each party. A copy of the valid recognition letter as issued by office of drug controller general of India (DCGI) for approval as bioavailability/bioequivalence study centre (for laboratories where biological samples are being received for BA/BE studies). For transfer of samples, the Indian applicant should follow the 'Guidance on regulations for the transport of Infectious substances (2009-2010)' as published by World Health Organization. There are specific packing instructions as per United Nations class (6.2) specifications to be followed during transport of infectious substances. Unless otherwise declared the biological materials such as blood and/or blood components; dried blood spots and faecal occult blood; medical or clinical wastes are to be considered under the 'infectious substance category'. The applicants are required to indicate the category under which the infectious substances/organisms fall. In addition to categories indicated as per UN class specifications in WHO guidelines(2009-10), the applicant should also refer to the relevant categories mentioned under SCOMET items in schedule of India's Foreign Trade Policy classification as well as Animal and Human pathogens scheduled as Risk Groups in the Ministry of Environment and Forests Notification,GoI,1989. Accordingly, the 'category' in terms of infectious nature/risk group of biological substances to be transferred is required to be assigned and indicated by the applicant. ]]> <![CDATA[Supreme court order in Novartis case a major victory: MSF]]> https://biospectrumindia.com/news/95/3206/supreme-court-order-in-novartis-case-a-major-victory-msf.html https://biospectrumindia.com/news/95/3206/supreme-court-order-in-novartis-case-a-major-victory-msf.html Tue, 02 Apr 2013 18:42:00 +0530 The landmark decision by the Indian Supreme Court in Delhi to uphold India's Patents Act in the face of the seven-year challenge by Swiss pharmaceutical company Novartis is a major victory for patients' access to affordable medicines in developing countries, the international medical humanitarian organisation Doctors Without Borders/MÃ©decins Sans FrontiÃ¨res (MSF) stated on April 01, 2013. "This is a huge relief for the millions of patients and doctors in developing countries who depend on affordable medicines from India, and for treatment providers like MSF," said Dr Unni Karunakara, MSF International President. "The Supreme Court's decision now makes patents on the medicines that we desperately need less likely. This marks the strongest possible signal to Novartis and other multinational pharmaceutical companies that they should stop seeking to attack the Indian patent law." India began granting patents on medicines to comply with international trade rules, but designed its law with safeguards - including a clause known as Section 3(d) -that prevent companies from abusing the patent system. Section 3(d) prevents companies from gaining patents on modifications to existing drugs, in order to ever extend monopolies. Novartis first took the Indian government to court in 2006 over its 2005 Patents Act because it wanted a more extensive granting of patent protection for its products than offered by Indian law. In a first case before the High Court in Chennai, Novartis claimed that the Act did not meet rules set down by the World Trade Organization and was in violation of the Indian constitution. Novartis lost this case in 2007, but launched a subsequent appeal before the Supreme Court in a bid to weaken the interpretation of the law and empty it of substance. All of Novartis's claims have been rejected by the Supreme Court today. "Novartis's attacks on 3(d), one the elements of India's patent law that protect public health, have failed," said Leena Menghaney, India Manager for MSF's Access Campaign. "Patent offices in India should consider this a clear signal that the law should be strictly applied, and frivolous patent applications should be rejected." Although Novartis's repeated legal attacks on 3(d) were aiming to ensure even more patents were granted in India including on existing medicines, the company has raised concerns about the implications of the decision on the larger question of financing of medical innovation. "At the moment medical innovation is financed through high drug prices backed up by patent monopolies, at expense of patients and governments in developing countries who cannot afford those prices," said Dr Karunakara. "Instead of seeking to abuse the patent system by bending the rules and claiming ever longer patent protection on older medicines, the pharmaceutical industry should focus on real innovation, and governments should develop a framework that allows for medicines to be developed in a way that also allows for affordable access. This is a dialogue that needs to happen. We invite Novartis to be a part of the solution, instead of being part of the problem." ]]> <![CDATA[Hypertension a major killer disease: WHO]]> https://biospectrumindia.com/news/95/3199/hypertension-a-major-killer-disease-who.html https://biospectrumindia.com/news/95/3199/hypertension-a-major-killer-disease-who.html Tue, 02 Apr 2013 18:21:00 +0530 The World Health Organizations is raising the alarm about high blood pressure on World Health Day 2013. High blood pressure or hypertension kills nearly 1.5 million people every year in South-East Asia making it the single-most important risk factor for non communicable diseases like heart attack and stroke. Between 2011-2015 the cumulative loss in productivity associated with noncommunicable diseases in low and middle income countries is projected to be US$ 7.3 trillion. Most of these deaths can be prevented through healthy lifestyles, early detection and treatment. Hypertension is a silent killer because many people do not realize that they have it or are reluctant to start treatment on time, putting them at risk of complications. It is treatable through medication. Preventing high blood pressure must be a public health, social, economic and development priority. This is only possible through political will and increased public awareness. "Every individual has the power to prevent high blood pressure by adopting a healthy lifestyle- eating a balanced diet, reducing salt, regular exercise, avoiding harmful use of alcohol, quitting tobacco and checking their blood pressure regularly" said Dr. Samlee Plianbangchang, WHO Regional Director for South-East Asia. "Governments need to create health promoting environments that enable people to adopt healthy lifestyles. Regulations need to be in place to decrease the amount of salt in packaged food and make healthier foods affordable and accessible" he added. Preventing, detecting and treating hypertension early is cheaper than interventions such as cardiac bypass surgery or dialysis that may be needed if the condition is diagnosed late. Acknowledging this as a serious global issue, in September 2011, the United Nations General Assembly adopted the Political Declaration of the High-Level Meeting on the Prevention and Control of Non-communicable Diseases, and committed governments to a series of actions. Member States have agreed to nine global targets for prevention and control of noncommunicable diseases, which include reducing the prevalence of hypertension by 25% by 2025. The World Health Organization is now developing a global plan of action for 2013-2020 for the prevention and control of noncommunicable diseases. WHO is assisting countries to develop national action plans and set national targets to track progress in preventing and controlling such diseases, including hypertension, and their key risk factors. ]]> <![CDATA[G V Prasad is now the Chairman of Dr.Reddys]]> https://biospectrumindia.com/news/95/3043/g-v-prasad-is-now-the-chairman-of-dr-reddys.html https://biospectrumindia.com/news/95/3043/g-v-prasad-is-now-the-chairman-of-dr-reddys.html Tue, 02 Apr 2013 15:20:00 +0530 Dr. Reddy's Laboratories have announced that its Board of Directors have appointed GV Prasad, presently Vice-Chairman and CEO as the Chairman and CEO and Satish Reddy, the late Dr.Anji Reddy's son, as Vice-Chairman in addition to his present role of Managing Director and COO. This change would be effective from 30 March, 2013. The shift comes after the demise of the Founder chairman of DRL, Dr.Anji Reddy last month. Mr.G.V.Prasad, is the son-in-law of the late Dr.Anji Reddy. Mr. Prasad has lead the core team which drives growth and performance at Dr. Reddy's. He is known to be the architect of the company's successful Global Generics and API strategies, and has spearheaded Dr. Reddy's foray into Biosimilars and Differentiated Formulations.A chemical engineer from the Illinois Institute of Technology in Chicago, he additionally holds a Master's degree in Industrial Administration from Purdue University, US. Mr.Satish Reddy, now vice chairman and MD, steers two of the company's core businesses; Pharmaceutical Services and Active Ingredients (PSAI) and Global Generics businesses. He received the 2009 Distinguished Alumnus Award from the School of Pharmacy and Pharmaceutical Sciences, Purdue University, U.S.A. Also, he was identified as a "Young Global Leader for 2007" by the World Economic Forum. He holds a degree in Chemical Engineering from Osmania University, India, and an M.S. in Medicinal Chemistry from Purdue University, USA. ]]> <![CDATA[Role of agricultural R&D vital for food security : Tariq Anwar]]> https://biospectrumindia.com/news/95/3189/role-of-agricultural-rd-vital-for-food-security-tariq-anwar.html https://biospectrumindia.com/news/95/3189/role-of-agricultural-rd-vital-for-food-security-tariq-anwar.html Tue, 02 Apr 2013 12:25:00 +0530 On his recent visit to the Directorate of Coldwater Fisheries Research (DCFR), Bhimtal, Minister of State for Agriculture and Food Processing Industries Tariq Anwar, showed keen interest in visiting different laboratories and infrastructure. The minister also addressed the gathering of scientists and farmers and appreciated the scientific progress made by the Indian Council for Agricultural Research (ICAR) in the field of crops, vegetables, animal and fisheries. The role of scientific organizations working in these areas under the ICAR system have done commendable work in bringing India's food production at record high level. Role of agriculture in alleviating poverty and creating opportunity for employment were also emphasized by the Minister. Mr Anwar also felicitated progressive farmers from Uttarakhand state and congratulated them for doing commendable work. He also released the ISO 9001:2008 certificate conferred to the DCFR and inaugurated the website of the institute. Directors of various ICAR institutes of the region were also present on the occasion. During the visit, he also distributed fish seeds to the progressive farmers from Uttarakhand. Dr A Barat, Director, DCFR welcomed and briefed him on the ongoing activities and research programme of the institute. ]]> <![CDATA[Government claims it did enough to boost R&D ]]> https://biospectrumindia.com/news/95/3209/government-claims-it-did-enough-to-boost-rd-.html https://biospectrumindia.com/news/95/3209/government-claims-it-did-enough-to-boost-rd-.html Tue, 02 Apr 2013 11:27:00 +0530 According to the release from science and technology ministry on Apri1, 2013, the government has taken a number of steps to encourage scientists to engage in quality research and development. These measures include successive increase in plan allocations for scientific departments, setting up of new institutions for science education and research, creation of centres of excellence and facilities in emerging and frontline areas in academic and national institutes, induction of new and attractive fellowships, strengthening infrastructure for Research and Development (R&D), encouraging public-private research and development (R&D) partnerships, etc. Launching of programmes like nano mission, Mega Facilities, Open Source Drug Discovery (OSDD), Climate Change Studies, National Biotechnology Development Strategy (NBDS), etc. and creation of a new structure for basic research by establishing a Science and Engineering Research Board (SERB) in the country demonstrates the commitment of the Government to encourage and promote research in a better scientific environment. Sharing of proceeds with scientists from sponsored projects, consultancy projects, premia and royalty received from the industry; mobility of scientists between national labs, academia and industry; knowledge alliance with private industry to pursue product driven R&D and establishment of incubation centres to nurture start-up companies and enable chances of commercialization; investment of knowledge base as equity in enterprises and incentives for performing scientists etc. are some of the initiatives aimed at scientists to take up challenging research so that Indian Science could compete with the other countries. ]]> <![CDATA[Supreme Court denial of Glivec patent discourages future innovation in India ]]> https://biospectrumindia.com/news/95/3876/supreme-court-denial-of-glivec-patent-discourages-future-innovation-in-india-.html https://biospectrumindia.com/news/95/3876/supreme-court-denial-of-glivec-patent-discourages-future-innovation-in-india-.html Mon, 01 Apr 2013 17:31:00 +0530 A decision issued by the Indian Supreme Court regarding the Novartis breakthrough medicine Glivec (imatinib mesylate) provides clarification on Indian patent law and discourages innovative drug discovery essential to advancing medical science for patients. The Supreme Court denied an appeal challenging the rejection of a patent for Glivec, a life-saving medicine for certain forms of cancer, patented in nearly 40 countries including China, Russia, and Taiwan. Novartis filed a Special Leave Petition with the Indian Supreme Court in 2009 challenging the denial of the Glivec beta crystal form patent on two grounds, based on Sections 3(d) and 3(b) of the Indian patent law. In addition to seeking a patent for Glivec, the company filed the case to help clarify these unique aspects of the patent law. Reacting to the Supreme Court's verdit, Mr Ranjit Shahani, Vice Chairman and Managing Director, Novartis India said, "Novartis has never been granted an original patent for Glivec in India. We strongly believe that original innovation should be recognized in patents to encourage investment in medical innovation especially for unmet medical needs. We brought this case because we strongly believe patents safeguard innovation and encourage medical progress, particularly for unmet medical needs. This ruling is a setback for patients that will hinder medical progress for diseases without effective treatment options." The primary concern of this case was with India's growing non-recognition of intellectual property rights that sustain research and development for innovative medicines. As a leader in both innovative and generic medicines, Novartis strongly supports the contribution of generics to improving public health once drug patents expire. Novartis maintained that it remains committed to patients and access to medicine. Through its full donation programs, Novartis provides Glivec free of charge to 95 percent of patients prescribed the drug in India, currently more than 16,000 patients. The remaining 5 percent of patients are either reimbursed, insured, or participate in a very generous co-pay program. Since Novartis began its first donation program in 2002, the company has provided more than $ 1.7 billion worth of Glivec to patients in India. ]]> <![CDATA[Cardiac Science to focus on resuscitation business ]]> https://biospectrumindia.com/news/95/4328/cardiac-science-to-focus-on-resuscitation-business-.html https://biospectrumindia.com/news/95/4328/cardiac-science-to-focus-on-resuscitation-business-.html Mon, 01 Apr 2013 16:44:59 +0530 Cardiac Science, an Opto Circuits group company, signed a definitive agreement to sell its Diagnostic Cardiology product line to Mortara Instrument, Inc. for an estimated consideration of $ 21 million. The transaction does not include MySense, the novel, wearable, single-patient ECG recorder system and the Resuscitation business unit that markets automated external defibrillators (AEDs) worldwide. "Divestiture of the Diagnostic Cardiology product line will bring more strategic focus to Cardiac Science. The company will now be able to exclusively focus on innovation and the expansion of market share in its high-margin and high growth Resuscitation Business," said Mr Neal Long, CEO, Cardiac Science. "The addition of these businesses to our organization represents a marked opportunity to accelerate the introduction of Mortara's leading ECG technology to new markets," commented Dr. Justin Mortara, CEO, Mortara Instrument. ]]> <![CDATA[Peder Holk Nielsen is new Novozymes' CEO]]> https://biospectrumindia.com/news/95/3187/peder-holk-nielsen-is-new-novozymes-ceo.html https://biospectrumindia.com/news/95/3187/peder-holk-nielsen-is-new-novozymes-ceo.html Mon, 01 Apr 2013 16:05:08 +0530 In a planned transition, Mr Peder Holk Nielsen took over as the president and chief executive officer of Novozymes on April 1 from Mr Steen Riisgaard, who stepped down after 12 years in the company's top post and 33 years in Novozymes and Novo Industri/Novo Nordisk. Mr Peder Holk Nielsen, 56, has played a central role in the development of Novozymes in its current form. His 28-year career in Novozymes and Novo Industri/Novo Nordisk spans management positions across business development, research and development, quality management and sales and marketing. Up until his appointment as CEO, he served as Executive Vice President and Head of Enzyme Business from 2007-2013. On his elevation to the new leadership position, Mr Peder Holk Nielsen said, "I am proud and honored to lead this great company forward. Novozymes is in a very strong position, and we will continue with our overall strategy. Our success rests on our ability to bring new innovation to our customers, and our ability to find new ways biotechnology can help them improve their products and make more with less. A key focus for me will be to make sure we bring these innovations to the market even faster than we do today." Mr Peder Holk Nielsen is joined by a new executive leadership team from April 1, 2013. The team includes Mr Thomas VidebÃ¦k, executive vice president, Business Development, Mr Andrew Fordyce, executive vice president, Business Operations, Mr Thomas Nagy, executive vice president, Supply Operations, Dr Per Falholt, executive vice president, Research & Development and Mr Benny D. Loft, executive vice president and chief finance officer, Corporate Functions. With over 700 products used in 130 countries, Novozymes, on January 21, announced three new long-term financial targets for the next five years; Average organic sales growth of more than 10 percent (from 2015 onward), EBIT margin of more than 24 percent and Return on invested capital of more than 22 percent. ]]> <![CDATA[IPA welcomes Supreme Court order in Novartis case ]]> https://biospectrumindia.com/news/95/3174/ipa-welcomes-supreme-court-order-in-novartis-case-.html https://biospectrumindia.com/news/95/3174/ipa-welcomes-supreme-court-order-in-novartis-case-.html Mon, 01 Apr 2013 14:02:00 +0530 The Indian Pharmaceutical Alliance (IPA) has welcomed the judgement of the Supreme Court of India upholding the refusal by the Patent Office to grant a patent to Novartis for the Î²-polymorphic form of imatinib mesylate. IPA calld it a landmark judgement that will serve to set at rest the controversy that was raised regarding the scope of section 3(d) in the Patents Act, which is a crucial safeguard against the extension of patent monopolies of known drugs and the consequent delay in the availability of affordable generic versions. In an email statement mailed to BioSpectrum, Mr D G Shah, secretary general, IPA said, "Imatinib is on the National List of Essential Medicines and is an important drug in the treatment of several cancers such as certain blood and stomach cancers. The decision of the Supreme Court will come as a relief to patients suffering from these dreadful diseases as several Indian companies including Cipla, Ranbaxy and Natco can continue marketing imatinib at a fraction of the cost of the Novartis product." "The IPA was an intervenor in the litigation before the Supreme Court as Novartis had raised far reaching questions of patent law which could potentially impact access to affordable medicines by extension of patent monopolies to new forms of known medicines. The IPA supported the refusal by the Patent Office to grant the patent to the Î²-polymorphic form of imatinib mesylate", said the statement further. The interpretation of section 3(d) was the crux of the controversy. Section 3(d) prohibits the grant of patents to new forms of known substances, unless the new form results in enhanced efficacy over the known substance. The purpose of the section is to ensure that patent monopolies are not extended and generic versions delayed, unless the new form results in enhanced efficacy. The first patent for imatinib and its salts, including the mesylate salt, was applied for by Novartis in Switzerland in April 1992 and thereafter in other countries. No application could be filed in India as drugs were not patentable at that time. Over five years later, in 1997, Novartis filed its first application in Switzerland for the grant of a new crystalline form of imatinib mesylate - the Î²-polymorphic form. This application was also filed in India in 1998. By this time, India was accepting patent applications for new medicines, in conformity with the TRIPS Agreement and these applications were to be examined for grant after 2005. The Patent Office rejected the patent application of Novartis for the Î²-polymorphic form of imatinib mesylate on various grounds in 2006, including that a patent could not be granted for the Î²-polymorphic form under section 3(d) as it did not have any increase in efficacy over the previously known substance. Novartis appealed the rejection of the patent by the Patent Office before the Intellectual Property Appellate Board (IPAB) in 2007, but the appeal was dismissed in 2009. Aggrieved by this dismissal, Novartis went up to the Supreme Court which has now confirmed the rejection of the patent. ]]> <![CDATA[Supreme Court rules against Novartis in Glivec case]]> https://biospectrumindia.com/news/95/3125/supreme-court-rules-against-novartis-in-glivec-case.html https://biospectrumindia.com/news/95/3125/supreme-court-rules-against-novartis-in-glivec-case.html Mon, 01 Apr 2013 10:52:00 +0530 According to news reports just in, the Supreme Court has ruled against Novartis in the Glivec case and has rejected its plea for the grant of the patent for the drug molcule. Novartis had applied for a patent for the beta-crystalline version of the drug, on the basis of increased safety due to the modifications in the chemical entity. For more background see here and here. Mr.Ranjit Shahani, CMD, Novartis India has said that, "We fought this case because we strongly believe patents safeguard innovation and encourage medical progress, particularly for unmet medical needs. This ruling is a setback for patients that will hinder medical progress for diseases without effective treatment options." Novartis maintained that even though 95%of patients receive Glivec through the Glivec Patient Access Program (GPAP), they still pursued the case to gain a clarity into the Indian patent system. An official statement from Novartis claimed that "The Supreme Court denial of Glivec patent clarifies limited intellectual property protection and discourages future innovation in India." Mr. Ranjit Shahani however added that the "GPAP would continue regardless of the judgement". This has been hailed by NGOs and patient advocacy groups as a win over the notorious practice of evergreening. Section 3d of the Indian Patents Act, has special provisions against it. Leena Menghaney, India manager for MSF's Access Campaign said, "Patent offices in India should consider this a clear signal that the law should be strictly applied, and frivolous patent applications should be rejected". According to TV reports, while reading out the judgement, the honourable judge in this case said," the claim does not mean any standards of novelty and inventiveness". Also it has been said that the new patent cannot be granted, since it is not a major modification. NGO's have called the decison as landmark one for affordable medicines for the general public. Dr Dr Unni Karunakara, MSF International president added, "Instead of seeking to abuse the patent system by bending the rules and claiming ever longer patent protection on older medicines, the pharmaceutical industry should focus on real innovation, and governments should develop a framework that allows for medicines to be developed in a way that also allows for affordable access. This is a dialogue that needs to happen. We invite Novartis to be a part of the solution, instead of being part of the problem." Cipla, one of the largest generic firms in the world, also produces the generic version of Glivec at less than 10 times its innovator price. Dr.Y.K.Hameid, non -executive chariman,Cipla commented,"The judgement in the Novartis case is a victory for patients both in India and around the world. We are pleased with the judgement which prevents the use of frivolous patents to deny access to medicines for patients. India, being the 'Pharmacy Capital of the World' can continue to produce affordable, high quality medicines without the threat of patents for minor modifications of known medicines. This judgement will not only benefit patients in India, but patients around the world." Legally, Novartis can apply for a review petition, but experts claim that it will not have much impact on course of the decision.Novartis said that they had no comments on the same. The Novartis Glivec case had gained mythic proportions during the last few years, in intellectual property circles, because of the anticipated effect on how big pharma would view India. In a press briefing after the judgement, Mr.Shahani himself commented that over the years, "Glivec (had)got a larger than life perspective." The SC verdict comes close on the heels of a number of decisions going against the interests of the innovator pharma industry, such as revocation of patents and the grant of compulsory licenses. It remains to be seen, if the industry's popular claim that such an environment would hamper innovation and discourage big pharma from investing in India would hold true. Mr. Shahani too added,"I don't think anyone would want to invest given the current atmosphere." ]]> <![CDATA[India, UK to support joint research in crop genomics]]> https://biospectrumindia.com/news/95/3118/india-uk-to-support-joint-research-in-crop-genomics.html https://biospectrumindia.com/news/95/3118/india-uk-to-support-joint-research-in-crop-genomics.html Mon, 01 Apr 2013 10:31:00 +0530 Food security is one of the key challenges facing the world's scientists. One way to address that is to improve the characteristics of crops of global importance, and this can be done using genomic approaches. Recognizing that, the Department of Biotechnology (DBT), India and the Biotechnology and Biological Sciences Research Council (BBSRC), UK, has given a joint call that focuses on crops of interest to both the India and UK; wheat, brassicas (vegetable and oilseed) and Solanaceae (principally tomato, potato and aubergine/eggplant). Both the organizations have each earmarked up to £5 million for this call and projects should be up to a maximum duration of three years. Earlier in May 2012, DBT and BBSRC held a joint workshop in Norwich for invited experts, in different areas of crop genomics and bioinformatics research from India and the UK, to discuss the relative research strengths, and in some cases research gaps, that exist in different areas of crop genomics and associated bioinformatics research within the two countries. The ultimate aim of the workshop was to identify areas of complementarity and synergy which could form the basis of future collaborative joint working between India and UK. This call for collaborative proposals will require applicants based in India and the UK to work together in partnership within cross national teams on research projects where the India-based component would be funded by DBT and the UK-based component would be funded by BBSRC. The eligibility to apply will be determined by national eligibility rules. The nature of the resources requested must also adhere to national guidelines. Priority areas for this call fall into two categories: enabling technologies and trait-oriented research. The enabling technologies include bioinformatics, next generation sequencing, TILLING platform, genetic diversity resources, high throughput chemical profiling. The trait-oriented research are crop stress biology, resource use efficiency, product quality, plant architecture. DBT and BBSRC will conduct an integrated peer review process involving external referees. Applications will be ranked by an international panel of experts in December 2013 and a decision for funding will be made by February 2014. It is expected that all awarded grants will commence soon after March, 2014. The deadline for receipt of full proposals is time on 19th June 2013. ]]> <![CDATA[Dr. Reddy's launches Accutane generic]]> https://biospectrumindia.com/news/95/7833/dr-reddys-launches-accutane-generic.html https://biospectrumindia.com/news/95/7833/dr-reddys-launches-accutane-generic.html Fri, 29 Mar 2013 11:30:00 +0530 Dr. Reddy's Laboratories announced today that it has launched Zenatane (Isotretinoin Capsules USP) in 20 mg and 40 mg. This is a therapeutically equivalent generic version of Accutane (Isotretinoin Capsules USP) in the US market on March 28, 2013 following the approval by the United States Food & Drug Administration (USFDA) of Dr. Reddy's ANDA for Zenatane. According to IMS Health,the total market had U.S. sales of approximately $309 Million for the most recent twelve months ending January 2013. Dr. Reddy's Zenatanecapsules 10 mg, 20 mg, & 40 mg will be available in boxes of 30 (3 prescription packs of 10 capsules), as unit dose blisters. ]]> <![CDATA[Puducherry govt partners with Abbott for diseases awareness]]> https://biospectrumindia.com/news/95/3204/puducherry-govt-partners-with-abbott-for-diseases-awareness.html https://biospectrumindia.com/news/95/3204/puducherry-govt-partners-with-abbott-for-diseases-awareness.html Thu, 28 Mar 2013 18:04:29 +0530 The Government of Puducherry and Abbott have recently signed a three-year agreement to improve awareness of Non-Communicable Diseases (NCDs) like diabetes, hypertension and dyslipidaemia (cholesterol related disorders) and thyroid disorders and also implement initiatives to fight them and record their prevalence in the union territory of Puducherry. The government of Puducherry will provide the infrastructure and the necessary permissions and logistical arrangements in the Union Territory to run the project, while Abbott will provide subsidised diagnostics, educational support to healthcare providers, patient awareness material and will conduct diet guidance camps. Abbott will also provide Non-Communicable Disease management kits (including supplies to measure blood pressure, body mass index and blood glucose) and 150,000 glucose test strips free of cost to support monitoring of diabetes, as well as access to a unique internationally-recognized, evidence-based disease risk and health assessment tool. The partnership program will reach out to the union territory's citizens and screen/monitor over seven lakh people, which is the general population of Puducherry who are thirty years or above. It will also build the skills of local healthcare providers through continued medical education. This partnership for integrated health management is the first of its kind to be initiated by a government in India to capture and assess reliable population level screening/monitoring data. This data will help to create health risk maps to forecast the burden of these non-communicable diseases, facilitate early intervention, and ultimately help reduce disease burden in the Union Territory of Puducherry. The health assessment tool will help the Government of Puducherry's healthcare providers to assess each individual's health risks and support the public health ecosystem to create a personalized care plan to drive better health outcomes for patients and increase the focus of preventive care. The assessment of population-level data of diabetes, hypertension, cholesterol and thyroid disorders will project the likely disease pattern over a period of three years, thereby enabling a targeted approach to reduce the Union Territory's disease burden and also favorably impact the associated social and economic burden. The partnership aims to focus on diseases with a significant, and often growing, impact in India. With an estimated 61.3 million people living with diabetes, India currently accounts for almost 17% of the global diabetic population. A further 77.2 million people in India are at risk of developing diabetes. Over a period of time, diabetes can damage the heart, blood vessels, eyes, kidneys, and nerves. The overall risk of dying among people with diabetes is at least double the risk of their peers without diabetes. An Indian Council of Medical Research (ICMR) study suggests that the country's incidence rate for dyslipidaemia is estimated to be 37.5% amongst adults aged between 15-64 years. Thyroid disorders in India are characterized by a high prevalence (approximately 11% of adult population), minimal diagnosis, low awareness and low involvement of doctors in treatment. The Chief Minister of Puducherry Mr. N. Rangaswamy said, "The partnership with Abbott is one of the first in the country for a state or Union Territory to build awareness, provide treatment and better manage chronic diseases for its citizens, using its existing public health infrastructure. This partnership will not only improve patient outcomes, but also help address the growing disease burden and the associated economic burden of Puducherry.Leveraging its diversified healthcare expertise in areas such as diagnostics and pharmaceutical therapies, Abbott is uniquely positioned to be the right partner for this integrated health management solution." Mr. Vivek Mohan, Senior Director, Global Integrated Health, Abbott, said: "Combating non-communicable diseases (NCDs) is a shared commitment in building a healthy society. Partnerships like these with government will help to prevent and manage these diseases effectively, in particular by strengthening the health care systems addressing NCDs." ]]> <![CDATA[CSR 30 rice variety empower farmers ]]> https://biospectrumindia.com/features/95/3194/csr-30-rice-variety-empower-farmers-.html https://biospectrumindia.com/features/95/3194/csr-30-rice-variety-empower-farmers-.html Thu, 28 Mar 2013 11:58:00 +0530 Mr Isham Singh and Mr Vikram Singh of Kachhwa village have been innovators and motivators for others in Haryana and adjoining states. Reason being that these farmers took challenge to grow variety CSR 30, a salt tolerant variety from Central Soil Salinity Research Institute (CSSRI), in moderately salt affected and reclaimed soils. From 11-13 quintals per acre (28 - 33 quintals per hectare), Isham Singh is now able to harvest 13-15 quintals grain yield per acre with the technical support of CSSRI scientists in field demonstrations. On the same lines, Vikram Singh, a young farmer of the same village also adopted CSR 30 in order to get better production from the sodic-saline soil. Encouraged by his success, his family purchased 30 acres of land near Itarasi, Madhya Pradesh, where he has started cultivating CSR 30. In the first year, he harvested about 30 quintals per hectare, while this year he has harvested about 37 quintals grain yield per hectare. Isham Singh while reporting the performance of CSR 30 mentioned that this variety has good potential to grow in saline and sodic environments, possesses good disease and insect pests' resistance, and has high market value and export demand.Other farmers of Kachhwa and nearby villages came in to contact with Mr. Isham Singh and developed a large knowledge network in cultivating CSR 30. Vikram Singh reported that CSR 30 has compatibility with wider soil and climatic conditions. This is a cash variety and it has a greater market demand than others. Now, it has been realized that genetic attributes, wider flexibility and better market demand of CSR 30 could make it popular in diverse agroecosystems; and made it being a most popular rice variety in salt affected and sodic soils through farm led extension system. Even in the areas having normal soils without the problems of salinity and sodicity stresses, CSR 30 rice variety is giving better performance. According to the latest estimates, about 60 per cent area of basmati rice cultivation is captured by CSR 30 in Haryana state and has been reported as better than the earlier basmati varieties. According to Dr S K Sharma, head, Crop Improvement at CSSRI, Karnal, "the successful cultivation of CSR 30 variety has increased production and income of farmers. Haryana State Seed Production and Development Corporation, National Seed Corporation and other government and private seed agencies also supported in increasing the production potential through production and supply of good quality seeds." ]]> <![CDATA[Aanjaneya Lifecare to launch "Operation Hunger Free Mission" ]]> https://biospectrumindia.com/news/95/3197/aanjaneya-lifecare-to-launch-operation-hunger-free-mission-.html https://biospectrumindia.com/news/95/3197/aanjaneya-lifecare-to-launch-operation-hunger-free-mission-.html Wed, 27 Mar 2013 17:46:46 +0530 Mumbai-based Aanjaneya Lifecare, the vertically integrated pharmaceutical company with manufacturing and marketing capabilities in APIs (Active Pharmaceutical Ingredients) with focus on anti-malarial, and finished dosage forms (FDFs) catering to various therapeutic segments has undertaken the task of addressing the social issues in its CSR initiatives to help increase the larger cause, that of, avoid classroom hunger,- increase school enrolment, increase school attendance, improve socialization among castes, address malnutrition & empower women through employment. The pharma major in Mumbai has decided to plunge into the social sector keeping in view the central Government's call to reach out to poor and needy. Aanjaneya Lifecare has formed Aanjaneya Lifecare Foundation. The CSR wing of Aanjaneya Lifecare, Aanjaneya Lifecare Foundation aims to implement the Mid- Day Meal Programme in order to increase the number of children to achieving the two most critical Millennium Development Goals: elimination of hunger and universalization of primary education. Launching the Foundation, Dr Kannan Vishwanath, Founder Chairperson of Aanjaneya Lifecare Foundation said, "Surveys indicate that nearly 8.1 million children in India are out of school. Economic and social circumstances force these children to forgo education and engage in doing menial jobs in order to earn a single meal a day. Research shows that universal education has lagged because of the prevailing hunger and malnutrition state. These two factors reduce school enrolments, hamper performance levels and increase school drop-out rates, especially among girls. Hunger especially classroom hunger impairs a child's performance even if they do attend school. At this juncture, apart from the role of NGOs in child education, the Mid-Day Meal Scheme acts as a huge incentive in bringing these children to school. It prevents them from working and instead encourages them to study and get educated. In this way the programme also helps in the universalization of primary education". ]]> <![CDATA[American firm to distribute pain relievers in India ]]> https://biospectrumindia.com/news/95/3196/american-firm-to-distribute-pain-relievers-in-india-.html https://biospectrumindia.com/news/95/3196/american-firm-to-distribute-pain-relievers-in-india-.html Wed, 27 Mar 2013 16:31:00 +0530 An American biotechnology company, Nutra Pharma Corporation that is developing treatments for Multiple Sclerosis (MS), Human Immunodeficiency Virus (HIV), Adrenomyeloneuropathy (AMN) and Pain, has received notification that their patent and trademarks for its Nyloxin line of pain relievers have been published in India's Official Journal. This allows for patent and brand protection, leading to eventual sales through Indian distributors. The company that markets several drug products for sale for the treatment of pain under the brands Cobroxin and Nyloxin, noted that its patent, "Use of Cobratoxin as an Analgesic," was published in the Official Journal No.: 09/2013 of the Indian Patent Office (IPO) on March 1, 2013. The Trademarks for Nyloxin are registered in India under Class 5, which represents a Pharmaceutical or a dietetic substances adapted for medical use. "The patent and trademark publications in India represents one of the more significant international market opportunities for Nyloxin," said Mr Rik J Deitsch, Chairman and CEO of Nutra Pharma Corporation. "Now that we have patent protection to protect our formulas and trademark protection to defend the brand we can work to create sales and distribution in India. With the population of India exceeding a billion people and with limited patient access to opioid-based pain relievers throughout the country, India represents a potentially significant customer base for Nyloxin," he concluded. Nyloxin is an over-the-counter (OTC) pain reliever clinically proven to treat moderate to severe (Stage 2) chronic pain. Nyloxin is currently available in the United States as an oral spray for treating back pain, neck aches, headaches, joint pain, migraines, and neuralgia, and as a topical gel for treating joint pain, neck pain, arthritis pain, and pain from repetitive stress. In addition to its everyday strength formulation, Nyloxin is also offered in an extra strength formula for more advanced, Stage 3, chronic pain. According to a 1998 study published in the Journal of the American Medical Association (JAMA), it was estimated that 19% of patients evaluated in India suffered from persistent pain. An additional 2007 report from the Journal of Pain and Symptom Management, documented that only 0.4% of India's population in need of opioids for pain relief had access to them. ]]> <![CDATA[Lupin recieves USFDA approval for hypertension generic]]> https://biospectrumindia.com/news/95/5915/lupin-recieves-usfda-approval-for-hypertension-generic.html https://biospectrumindia.com/news/95/5915/lupin-recieves-usfda-approval-for-hypertension-generic.html Tue, 26 Mar 2013 16:42:22 +0530 Pharma major, Lupin announced that its subsidiary Lupin Pharmaceuticals has received final approval for its Valsartan and Hydrochlorothiazide Tablets USP from the United States Food and Drugs Administration (USFDA) to market a generic version of Novartis' Diovan HCT Tablets. Lupin has already commenced shipping the product. Headquartered in Baltimore, Lupin Pharmaceuticals is the wholly owned U.S. subsidiary of Lupin Limited. Lupin's Valsartan and Hydrochlorothiazide Tablets USP is indicated for the treatment of hypertension, to lower blood pressure in patients not adequately controlled with monotherapy or as initial therapy in patients who are likely to need multiple drugs to achieve their blood pressure goals. According to IMS MAT Sept 2012 sales, Valsartan and Hydrochlorothiazide Tablets had annual U.S sales of approximately USD 1.7 billion. Lupin is currently the 5th largest generics company in the US market (by prescriptions), and has received 6 approvals in the last two months, seems to be in line to launch around 10 products for the current fiscal. The US contributed 42 % of Lupin's consolidated revenues for the third quarter of the current year and reported growth of 68 % for the US Market. The company has revenues of USD 506 million in revenues. ]]> <![CDATA[Dr.Reddy's settles claims against Nordion for $22.5 million]]> https://biospectrumindia.com/news/95/5797/dr-reddys-settles-claims-against-nordion-for-22-5-million.html https://biospectrumindia.com/news/95/5797/dr-reddys-settles-claims-against-nordion-for-22-5-million.html Mon, 25 Mar 2013 17:35:00 +0530 Dr. Reddy's Laboratories has settled its claims against Nordion Inc (formerly MDS Inc), headquartered in Ottawa, Canada, in a case pending in the United States District Court for a cash payment of USD 22.5 Million by Nordion to Dr. Reddy's. The settlement was concluded on 20 March 2013, with the receipt of the settlement funds by Dr. Reddy's. The case was brought by Dr. Reddy's in April 2009 seeking damages sustained by the company caused by a claimed breach by Nordion (then MDS) of its laboratory services agreement with Dr. Reddy's. Nordion, as a contract research organization, provided laboratory services to Dr. Reddy's, including bio-equivalency studies, to support Dr. Reddy's regulatory applications for approval of generic drugs, including Abbreviated New Drug Applications (ANDAs) filed with the United States Food and Drug Administration (the USFDA) for approval to market generic drugs in the United States. The case arose after the USFDA cited MDS with violations of good laboratory practices which caused the USFDA not to accept, without further substantiation, MDS's laboratory reports performed during the period 2000-2004. ]]> <![CDATA[Venus launches its first OTC anti stress formulation]]> https://biospectrumindia.com/news/95/3753/venus-launches-its-first-otc-anti-stress-formulation.html https://biospectrumindia.com/news/95/3753/venus-launches-its-first-otc-anti-stress-formulation.html Mon, 25 Mar 2013 16:36:00 +0530 While introducing this product Dr. (Mrs) Manu Chaudhary, Joint Managing Director, Venus Remedies said, "EZENUS is a unique medical nutrition product which is absolutely safe, zero calorie, non-addictive, herbal candy, with clinically proven anti-stress activity. It is world's first anti stress product launched in easy to use candy form even suitable for diabetic patients. It is highly safe in acute stress management such as exam stress in children and in chronic stress like in alcoholic and smoking population, without change in life style by continuous detoxification and strong antioxidant activity." EZENUS is a patent protected herbal, anti-stress formulation based on a German technology. It is a strong detoxifier candy free from side effects, with strong antioxidant, hepato-protective, and immune boosting activity which reduce stress without altering the physiological functions of the body. Dr. Chaudhary further added that EZENUS reduced more than 60% stress within 30 days without change in life style and significantly improves the quality of life in terms of physical, social, emotional and functional well- being. This product is suitable for all ages with safety established upto 10 times of advised dose i.e. 2-3 tablets per day.Ezenus is the outcome of continuous research, latest technology and thorough screening for safety and efficacy of more than 5 years. Commenting on this launch, Mr. Pawan Chaudhary, Chairman and Managing Director, Venus Remedies said, "With launch of 'EZENUS', a stress relieving candy, Venus is entering into the OTC segment for the first time. It is a moment of pride for all of us who have contributed towards this achievement. We are hopeful that this novel research product 'EZENUS' will acquire 5% of the 100 million USD direct market of stress segment in India, other than lifestyle disorders, within 3 years of its launch." The Company has plans to make EZENUS available pan-India within this calendar year to contribute in the reduction of stress in society thereby helping people in bringing balance to life. The Company will use its existing network of 50,000 pharmacists to distribute this product on pan-India basis. Further, an aggressive promotional campaign will be undertaken for broadening its reach. EZENUS will also be available for online purchase on its website wherein a toll free number would be available for customer queries. Venus Remedies, headquartered in Panchkula, Haryana (India), is among the 10 leading fixed-dosage injectable manufacturers in the world. Venus has won over 80 patents for its innovative research products worldwide. The company has presence in 60 countries and covering more than 75 products. Venus Medicine Research Centre (VMRC) located at Baddi, Himachal Pradesh, is a fully equipped interdisciplinary drug discovery and development centre, duly approved by Department of Scientific and Industrial Research (DSIR) Government of India. VMRC has achieved significant breakthrough in small molecule research for developing products helpful to combat antimicrobial resistance, utilizing novel targets and adjuvants which synergize with other antibiotics, minimizing potential for resistance. Significant breakthroughs have been achieved by VMRC in 'Antibiotic Adjuvant Entities' for notable resistance barriers like ESBLs, 'plasmid encoded carbapenem resistant metalo-beta-lactamases', MRSA, bacterial biofilms and C. difficile infection. ]]> <![CDATA[Hope for MDR-TB cure on the anvil, but further research required]]> https://biospectrumindia.com/news/95/6497/hope-for-mdr-tb-cure-on-the-anvil-but-further-research-required.html https://biospectrumindia.com/news/95/6497/hope-for-mdr-tb-cure-on-the-anvil-but-further-research-required.html Fri, 22 Mar 2013 17:25:00 +0530 After close to five decades of no news drugs being discovered for TB, two new drugs - bedaquiline and delamanid - have recently been or are about to be approved. Research is urgently needed to determine the best way to use these new drugs so that treatment can be made shorter and more effective, and rolled out to treat the growing number of people with MDR-TB. Medical humanitarian organisation MÃ©decins Sans FrontiÃ¨res (MSF) has warned that if measures to tackle multidrug-resistant tuberculosis (MDR-TB) are not significantly stepped up, including addressing barriers that prevent both research into better drug combinations and treatment scale up, MDR-TB rates will continue to increase worldwide and a historic opportunity to improve abysmal cure rates will have been squandered. The World TB day will be observed on this Sunday, March 24th,2013.India, Russia and China account for nearly 60% of the global MDR-TB case burden. Yet in 2011, less than one in five of an estimated 630,000 people with MDR-TB had been able to get the treatment they needed. With two new drugs available, high burden countries like India must scale up efforts to diagnose and treat MDR-TB now, so that robust programmes are in place once the new drugs are introduced. MSF has called out to people on MDR-TB treatment and their caregivers from around the world outline these and other demands in the Test me, treat me manifesto, and urge others to join their call for urgent action. The 'Test me, treat me' manifesto can be read here and see who signed it here "We have been waiting for half a century for new drugs that are effective against tuberculosis", said Joanna Ladomirska, Medical co-ordinator for MSF in India. "Having two new drugs on the point of being approved is a major opportunity to improve treatment for MDR-TB, and we can't afford to waste it. India must play a major role in researching how to use the new drugs in regimens that are much shorter, less toxic, and more effective." MSF projects in India are seeing increasing numbers of people with MDR-TB, with drug resistance found not only among patients who have previously failed TB treatment but also in patients newly diagnosed with TB, a clear sign that MDR-TB is being transmitted in its own right. Left untreated, the infectious disease is lethal. Even with appropriate diagnosis treatment today puts people through two years of excruciating side effects, including psychosis, deafness, numbness and constant nausea, with painful daily injections for up to eight months. Barely half of people get cured. India does not yet have enough prequalified laboratories to conduct the drug-sensitivity testing needed to scale up diagnosis of MDR-TB. Diagnosis in the private and public sector is often incomplete, leading to inappropriate treatment and spreading resistance. Scaling up the numbers of accredited labs for first and second-line drug-sensitivity testing is urgently needed to provide people with the appropriate TB treatment the first time, and to avoid amplification of resistance in India. ]]> <![CDATA[Claris to receive Rs 1050 crore FDI]]> https://biospectrumindia.com/news/95/7053/claris-to-receive-rs-1050-crore-fdi.html https://biospectrumindia.com/news/95/7053/claris-to-receive-rs-1050-crore-fdi.html Fri, 22 Mar 2013 16:56:10 +0530 Claris Otsuka Ltd, a joint venture between Indian life science company Claris Lifesciences and Japanese companies Otsuka Pharmaceutical Factory and Mitsui & Co received green singal from Foreign Investment Promotion Board (FIPB) to receive foreign direct investments to the tune of Rs 1050 crore. Operations at the new company are expected to start in late 2013 in Ahmadabad. At the FIPB meeting held on March 13, under the chairmanship of Mr Arvind Mayaram, Secretary, Economic Affairs, the government has approved 12 proposals of foreign direct investment amounting to Rs 2,609.27 crore approximately. It may recalled that Claris formed a joint venture with Otsuka Pharmaceutical and Mitsui & Co for its infusions business in India and emerging markets in December last year. The joint venture called Claris Otsuka will receive investments from the Japanese companies - Otsuka Pharmaceutical and Mitsui about $200 million and Otsuka will be holding a 60 percent stake, with Claris and Mitsui each owning 20 percent. Besides, a proposal from Menarini Raunaq Pharma for induction of foreign equity to tune of Rs 2 crore in its existing foreign promoter also received FIPB nod while FIPB has rejected the proposal of Erica Healthcare, Mumbai to increase in foreign equity. ]]> <![CDATA[India has no plans to introduce National Health Bill ]]> https://biospectrumindia.com/news/95/1230/india-has-no-plans-to-introduce-national-health-bill-.html https://biospectrumindia.com/news/95/1230/india-has-no-plans-to-introduce-national-health-bill-.html Fri, 22 Mar 2013 15:51:18 +0530 The Government of India has no plans to introduce National Health Bill. However Mr Abu Hasem Khan Choudhury, Minister of State for Health & Family Welfare, government of India said, "In order to provide relief to the common man in the area of healthcare, a countrywide campaign in the name of "Jan Aushadhi Campaign" has been initiated by the Department of Pharmaceuticals, in collaboration with the State Governments, by way of opening up of Jan Aushadhi Generic Stores in the Government Hosptials to supply of generic medicines through Central Pharma Public Sector Undertakings, to make available quality generic medicines at affordable prices to all. So far, 149 Jan Aushadhi Stores have been opened in different States/UTs in the country as on 28.02.2013. " Further, the minister said, "Under the provisions of the Drugs (Prices & Control) Order, 1995 (DPCO, 1995), the prices of 74 bulk drugs listed in its First Schedule and the formulations containing any of these scheduled drugs are controlled. National Pharmaceutical Pricing Authority (NPPA) fixes or revises prices of scheduled drugs/formulations as per the provisions of the DPCO, 1995. In respect of drugs not covered under DPCO, 1995 i.e. non-scheduled drugs, manufacturers fix the prices by themselves without seeking the approval of the Government/NPPA. However, the trend in prices of non-scheduled drugs is monitored and suitable action is taken by NPPA where price increase is more than 10% in a period of one year on moving basis. " The government has come up with notification on December 7, 2012 related to National Pharmaceutical Pricing Policy -2012 (NPPP-2012) which provides all the manufacturers/importers manufacturing / importing the medicines as specified under National List of Essential Medicines 2011(NLEM-2011) shall be under the purview of price control. The objective of NPPP-2012 is to put in place a regulatory framework for pricing of drugs so as to ensure availability of required medicines "essential medicines" at reasonable prices. "The Government is also providing support to the States under the NRHM for providing free Generic Drugs in Public health facilities. States have been encouraged to bring out essentials Drugs lists (EDL) facility wise and Standard Treatment Guidelines to promote safe and efficacious drug use,' said Mr Choudhury in written reply to a question in the LokSabha on March 22. ]]> <![CDATA[Bangalore to host 'All India Health Expo' from May 3]]> https://biospectrumindia.com/news/95/1143/bangalore-to-host-all-india-health-expo-from-may-3.html https://biospectrumindia.com/news/95/1143/bangalore-to-host-all-india-health-expo-from-may-3.html Thu, 21 Mar 2013 17:50:52 +0530 In order to educate people on ways to negotiate their health-life 'Manomya Media House' is organizing three-day 'All India Health Expo', with a theme of 'Reach 20-20, Universal Access to Health Care' at the Palace Grounds, Bangalore from May 3, 2013. About 200 healthcare firms across the globe are taking part in the three-day Expo. Noted heart surgeon and director of Fortis Hospital Dr. Vivek Javali, Dr. Venkataramana from BGS Global Hospital, Dr. Shanthanu Chattopadhyaya, Chief Executive Officer of Nationwide Primary Health Care Services, Mr Manimaran Rajakannu, global head, Wipro Technology and others will participate in the symposium. Dr.Neeraj Patil, Former Mayor of Lambeth and Mr Sham Banerji, CEO i2i Solutions will be making key note presenation. In addition, Dr.Balachandra Keni, MD Sagar Hospitals will be addressing the issue on Universal reach of Human Health Practitioners. During the three days the doctors and experts from various divisions of the healthcare sectors will share their experience and knowledge besides presenting the papers on several issues. Mr Lingaraju S.Patel, Managing Director, Manomya Media House said, "One of the few main aims of the Expo is to examine, discuss and recommend the broad strategies on achieving universal health coverage in the country. The Expo will provide a forum for discussion among doctors, public health experts, scientists, health administrators, solution providers and healthcare entrepreneurs on effective and appropriate strategies on universal coverage. At least 100 medicos from several reputed hospitals will also take part in the Expo." The expo would comprise of over 200 stalls spread over an area of 1.6 lakh square meters. A good number of local as well as international healthcare brands from various sections of the healthcare sector including pharmaceutical companies, medical devices companies, organizations in medical publishing, hospital management, telemedicine, healthcare IT and other related industries will display their products, solutions and capabilities. "A good number of doctors, experts in the medical field, people from different sectors and companies will participate in the Expo, which will offer an opportunity for both delegates and general public to interact with each other to know more about healthcare issues," said Dr.Prabhu Dev, Chairman, Karnataka Health Commission while releasing the brochure about the Expo along with Dr.Chinmay Chigateri, co-founder, HealthMinds on March 16. "Entry is free for the public. Experts from the prestigious hospitals would examine the health conditions of the attendants during the Expo. People can use the Expo as a platform to discuss their health issues with the doctors and seek their suggestions, "Mr Patel added. Agencies such as Indian Dental Association (IDA) Bangalore chapter, Private Hospitals and Nursing Homes Association (PHNA), Karnataka Udyog Mitra (KUM), Karnataka Health Commission (KHC), Nation-wide and Health Mind have joined their hand for the grand success of the Expo. ]]> <![CDATA[Biological E's Dr. V K Datla passes away]]> https://biospectrumindia.com/news/95/4604/biological-es-dr-v-k-datla-passes-away.html https://biospectrumindia.com/news/95/4604/biological-es-dr-v-k-datla-passes-away.html Thu, 21 Mar 2013 16:16:00 +0530 Dr. Vijay Kumar Datla, Chairman and Managing Director, Biological E passed away today. He was one of the early pioneers of the Indian vaccine industry, responsible for the operations of the company that has been one of the largest suppliers to the nation's Universal Immunization Programme. He was 67 years old. Biological E Limited was established over 50 years ago. It is the first private sector biological products company in India and the first pharmaceuticals company in South India. Dr.Datla, a doctor by profession has been with Biological E for 43 of those years. His daughter, Ms.Mahima Datla is currently the senior vice-president, Biological E. Biological E has been making great strides in developing new vaccines in the past year. It had launched a Japaneses Encephalitis vaccine last year, and recently entered into a JV with GSK for the development of a hexavalent vaccine as well. The company website stated that Dr. Vijay Kumar Datla, the man behind management's thrust, strongly believed in individual learning and development at Biological E. ]]> <![CDATA[Mahyco bags ABLE award for contributions to the agri-biotech sector]]> https://biospectrumindia.com/news/95/5935/mahyco-bags-able-award-for-contributions-to-the-agri-biotech-sector.html https://biospectrumindia.com/news/95/5935/mahyco-bags-able-award-for-contributions-to-the-agri-biotech-sector.html Thu, 21 Mar 2013 16:13:00 +0530 Maharashtra Hybrid Seeds Company or more commonly known as Mahyco, was recently felicitated with an award for 'Outstanding Contribution to the agriculture sector' by the Association of Biotechnology Led Enterprises (ABLE), the industry body for the biotech sector. Mahyco received this prestigious award under the 'Bio-Agri' category, in the presence of key national and international dignitaries on the occasion of ABLE's tenth anniversary celebration in New Delhi on March 11, 2013. The award was given to Mahyco based on the last ten years' performance of the company in the Agri Biotech sector, which was evaluated and judged by members of an independent jury on various parameters. On receiving this award Mr. Raju Barwale, Managing Director, Mahyco said that, "We are delighted to receive this prestigious award from ABLE which is in recognition of our path-breaking research to provide the cutting-edge agricultural technology to the farmers and improve their productivity and profitability. This honour will encourage us to continue to invest in research and development to enable the agriculture sector to contribute significantly to our economy." Since its inception, Mahyco has made significant contributions towards developing improved seeds. Over the past 15 years, Mahyco and its promoters have won several awards and honours including first national award for biotech product commercialization and the World Food Prize by the World Food Prize Foundation, USA. ]]> <![CDATA[Agila Biotech to invest $34.4 mn in Malaysia ]]> https://biospectrumindia.com/news/95/7870/agila-biotech-to-invest-34-4-mn-in-malaysia-.html https://biospectrumindia.com/news/95/7870/agila-biotech-to-invest-34-4-mn-in-malaysia-.html Thu, 21 Mar 2013 12:52:00 +0530 Agila Biotech, a Strides Acrolab Ltd (Strides) enterprise announced that Agila Biotech Sdn Bhd (Agila Biotech (Malaysia)) - its wholly owned subsidiary has entered into an agreement with Malaysian Bio-Xcell, a biotechnology park and ecosystem dedicated to healthcare and industrial biotechnology. With this deal Agila Biotech (Malaysia) joins Biocon (India), MetE x (France) and Glycos Biotechnologies (USA) as the early entrants into the Bio-Xcell ecosystem. The $34.4 million (RM107 million ) Build-and-Lease Agreement is for the establishment of a customized biotech facility located in the Bio-Xcell ecosystem in Nusajaya, Johor, Malaysia. The agreement will replace an earlier agreement signed in May 2011. The deal was signed between En. Rizatuddin Ram li, CEO of Bio-Xcell and Dr. Anand Iyer, CEO of Agila Biotech (Malaysia) a subsidiary of India-listed Strides Arcolab Ltd at the three day BioPharma Asia Convention (BioPharma Asia) happening in Singapore from March 19, 2013. Agila Biotech (Malaysia) has plans to develop a state-of-the-art, multi-product, scalable manufacturing facility with a production capacity for mammalian (2KL expandable up to 8KL) and microbial (500 L expandable up to 2KL) products. It also aims to develop advanced formulation/ fill finish facilities to meet Agila Biotech (Malaysia)'s business model which will support the manufacturing of internal pipeline products as well as CMO activities. These facilities will be able to support the production of Recombinant Monoclonal Antibodies (mAbs) from DS to DP, Recombi nant Therapeutic Proteins from DS to DP, CMO activities for DS and DP, chemistry and for mulation activities for PEGylation, novel formulation development and sterile fill finish facilities for vials, PFS, cartridges and lyophilized products. "Agila Biotech (Malaysia) is indeed poised to be a major anchor tenant for the Bio-Xcell ecosystem and we are extremely pleased to be able to offer our services and support for this promising project," said Mr Rizatuddin Ramli. Bio- Xcell will fund RM67.32 million (approximately $22 million) to be provided under the Build-and-Lease Agreement with Agila Biotech (Malaysia), which will cover the construction of the building and part of the equipment. All other related state-of-the-art equipment, integration service and testing of this turnkey project (estimated at $13-15 million) will be funded by Agila Biotech (Malaysia) from internal accruals and funding from external sources." The work on the facility for the end-to-end manufacturing of biologics located on an 8.77 acre plot is expected to start as soon as all necessary clear nces and permits have been obtained and all supplemental agreements have been executed. Both p rties are aiming for the R&D and manufacturing facilities to be operational by end 2014. Agila Biotech (Malaysia) also plans to incorporate into its facility at Bio-Xcell, the "next-generation" technology platforms which revolutionize the way biomolecules are developed, manufactured and commercialized. It is built around a unique platform that features the innovative application of single-use component technology and transforming biomanufacturing economics, thus reducing deployment of new manufact uring capacity from 3-5 years to a faster 12-18 months. There's also a significant capital Investment savings compared to conventional approaches. Dr. Anand lyer, noted that the facility in Bio-Xcell represents a strategic move to further bolster Agila Biotech (Malaysia)'s manufacturing presence in the region and tap into unmet global demand and window of opportunity in biologics. The proposed facility at Bio-Xcell will include a Mammalian Cell Culture Single-Use Technology Manu facturing Suite, a Microbial Fermentation Single-Use Technology Manufacturing Su ite, a Fill & Finish Suite, Analytical/ QC/R&D labs, utilities infrastructure and offices. Agila Biotech is also building a 15,000s q.ft, state-of-the-art biologics R&D facility in Bangalore that will support and complement its operations in Malaysia. ]]> <![CDATA[Piramal Enterprises launch portable diagnostic device]]> https://biospectrumindia.com/news/95/7370/piramal-enterprises-launch-portable-diagnostic-device.html https://biospectrumindia.com/news/95/7370/piramal-enterprises-launch-portable-diagnostic-device.html Thu, 21 Mar 2013 11:12:00 +0530 Piramal Enterprises' diagnostic division recently announced the launch of "QDx Instacheck" -Right-here-Right-now. It is touted to be a first-of-its-kind portable diagnostic device that is specifically designed to perform 20 clinical parameters and deliver quantitative results within 3 - 15 minutes. It covers wide therapeutic areas including cardiovascular disease, hormonal imbalance, emergency care, diabetes, oncology, infections, pregnancy and infertility management. This portable and affordable device is considered to deliver quantitative test results with high accuracy. The device is virtually maintenance free and can be operated very easily with minimal training requirements. QDx Instacheck is particularly useful for doctors' clinics, emergency care units (such as ICU, CCU), hospitals, pathological labs, IVF centres, ambulance services, pharmaceutical companies and NGOs engaged in healthcare services. Commenting on the launch Mr. Vijay Shah, Executive Director and Chief Operating Officer, Piramal Enterprises said, "It is our endeavour to empower the medical community such as gynaecologists, cardiologists, diabetologists, general physicians, pathological labs to perform critical tests Right-here-Right-now with minimum investment and lowest operating expenses and finally making treatment decisions faster. The launch of QDx Instacheck is in line with our division's vision of bringing affordable instant diagnostic solution through our point-of-care product range. This 1.3 kg portable device is the first-of-its-kind revolutionary instant diagnostic device in the Indian market that is poised to change traditional diagnostic methods to instant diagnosis." QDx Instacheck has been commercially test marketed from January to March 2013 across various parts of India through our field force and over 250 authorised distributors. The formal launch of the product is scheduled in April 2013. A record of 387 instruments was sold in just 45 days from test marketing launch. ]]> <![CDATA[UNITAID to fund project for researching pediatric TB treatments]]> https://biospectrumindia.com/news/95/4717/unitaid-to-fund-project-for-researching-pediatric-tb-treatments.html https://biospectrumindia.com/news/95/4717/unitaid-to-fund-project-for-researching-pediatric-tb-treatments.html Wed, 20 Mar 2013 18:18:00 +0530 In spite of an estimated 500,000 new annual cases of children with tuberculosis (TB), there are no appropriate medicines for them, UNITAID and the TB Alliance warn. With no alternatives available, treatment providers for children are forced to adapt medicines for adults as best they can, such as by cutting pills. This leads to improper treatment, treatment failure, spread of this highly-contagious disease, and conditions ripe for the development of drug-resistant strains of the bacteria. In response to this need, UNITAID is funding a TB Alliance project to better understand the barriers that manufacturers will have to overcome to enter the pediatric TB market and to work with those manufacturers to ensure that a correctly-dosed child-friendly formulation of existing first-line TB drugs will be available in a timely manner. This work will also help speed the development of other novel regimens for children that are now in the pipeline. TB, one of the world's most neglected diseases with almost no new treatments developed in the past 50 years, is one of the top ten causes of childhood death.It mostly affects the world's poorest, among those, the most vulnerable are children. Denis Broun, Executive Director of UNITAID says,"Despite the world's capabilities to address this disease, pediatric tuberculosis has been ignored for far too long, resulting in a complete lack of appropriate medicines. This project is designed to spur innovation so that the right kinds of treatments are available as quickly as possible and at affordable prices. We now need other global players to also step up, especially for identifying those children affected." The extent of the childhood TB pandemic is not fully understood. Most experts believe that TB in children goes largely undiagnosed and that the true scope of the problem is far higher than the estimates today. ]]> <![CDATA[Big pharma sets its eyes on acquiring Indian injectables companies]]> https://biospectrumindia.com/news/95/8141/big-pharma-sets-its-eyes-on-acquiring-indian-injectables-companies.html https://biospectrumindia.com/news/95/8141/big-pharma-sets-its-eyes-on-acquiring-indian-injectables-companies.html Wed, 20 Mar 2013 18:17:00 +0530 The last few months have seen a sizable number of Big Pharma companies showing interest in Indian injectible firms. Last month, Mylan bought Strides Arcolab's injectable drug unit for $1.6billion, paying the highest sales multiple ever for an Indian pharmaceutical company. And now according to Bloomberg, India-based Claris Lifesciences may be next in line to be taken over by one of the pharma giants. Rumors have it that Pfizer and Teva Pharmaceutical Industries have shown interest in acquiring this Ahmedabad-based company which has five manufacturing facilities in Ahmedabad and approval to ship drugs to the US. Sources say that the companies in question are gearing up to combat the shortage of medicines in the US through acquiring companies with approved manufacturing facilities. In 2011, there were 251 drug shortages reported in the US, out of which 183 involved sterile injectable drugs as reported on the FDA website. The agency believes that a major reason for these shortages has been quality issues apart from other issues such as production delays, etc. FDA acknowledges the fact that with fewer firms making older sterile injectable drugs, there are a limited number of production lines that can make these drugs. This small number of manufacturers and limited production capacity for sterile injections result in drugs being vulnerable to shortage and thus prompting the big pharma to bridge this shortage gap by acquiring the injectables unit. Manufacturing injectable drugs require sterile facilities to protect against unwanted contaminants and the FDA in the US has cracked down on manufacturers that fail to meet safety requirements. Mr Srinivasa Rao Aluri, managing director, Morgan Stanley, in a telephonic interview said, "The interest in buying injectables unit is high because FDA shut down a number of sterile facilities in the US so now these companies do not have sterile facilities to combat the contaminants and this pressure is making them acquire injectables unit from other FDA approved companies." In 2012 itself, FDA had sent 22 warning letters to number of companies. Ms Mridula Anand, researcher, Centre for Leadership, Innovation and Change, ISB believes that "With few players catering to niche segments, the injectables market poses high entry barriers to pharma and biotech companies. While due to stringent guidelines there are few FDA approved injectable manufacturing units in the US, the demand for sterile injectable drugs are growing. It is but natural for global firms to look towards India which have 'ready-to-run' sterile injectable drug manufacturing facilities."Claris in 2010 was barred from selling its products in the US after the US agency found that the company was producing contaminated drugs. Claris, however, resolved the issue in 2012 and addressed the complaints following which it was allowed to resume US sales. Recently the company also got FDA approval for its ninth drug. Pharma companies are constantly evaluating options for new innovative products while maintaining stringent quality. Firms such as Claris, Cadila, Dr. Reddy's and Sun Pharma have developed strong manufacturing capabilities for injectables. Ms Anand further says "Claris has built capabilities across most verticals with a global presence and extensive regulatory approval experience which could prove valuable." On being contacted by BioSpectrum , Pfizer responded by saying "we do not comment on market speculation or rumors." Pfizer was one of the companies which wanted to acquire Strides' injectable unit which ultimately went to Mylan. Since there are a number of important players who hold a strong ground in injectables space, pharma giants are turning towards India to resolve this issue. Mr Aluri says, "whether India is becoming a hub for acquisitions in injectables space is too early to say. This is a niche area and a lot of drugs are going off-patent. So this is a good trend that is happening. Same thing could be observed for biologics and this is a welcome trend that we are seeing." Given the growing number of Indian firm's interest in biosimilars and biobetters, injectable therapies are set to play a larger role due to the challenge of formulating oral drugs. Ms Anand concludes by saying, "these general trends indicate a preponderance of Indian pharma firms emerging as either independent entities or collaborative efforts." ]]> <![CDATA[Transasia Bio-Medicals bags award for its CSR activities]]> https://biospectrumindia.com/news/95/3176/transasia-bio-medicals-bags-award-for-its-csr-activities.html https://biospectrumindia.com/news/95/3176/transasia-bio-medicals-bags-award-for-its-csr-activities.html Wed, 20 Mar 2013 15:35:00 +0530 Transasia Bio-Medicals was recently conferred with the Global CSR Excellence and Leadership Award in the category of 'Innovation in Corporate Social Responsibilty Practices' in a ceremony held on 18th February, 2013. Dr. Saugata Mitra , Chief People Officer and Group HR Head, MotherDairy Fruit & Vegetable and Dr. Sanjay Muthal, Managing Director, Nugrid Consulting presented the award to Mr. G Jayaraman-Associate Vice President, HR, Admin & CSR, on behalf of Transasia. Inititated by Blue Dart, the event was attended by more than 200 delegates from renowned organizations such as ACC, HLL, HPCL, IOCL, M & M, Infosys, ONGC, OIL, Aditya Birla Group,Siemens , Max India, among others. Right from its inception, Transasia chose to make a meaningful contribution to society as one of the key goals of its business operations. With a focus on ensuring overall development for the underprivileged children, Transasia initiates a host of activities for the betterment of these children. The various programmes, emphasizing on the importance of education include study class program,computer education, regular contests, counselling sessions and career guidance, educational assistance,excursions, programmes for teachers and medical camps. As of date, more than 850 children have benefited from these programmes. Apart from these, the company continues to support the Thalassemia Society in various regions. In the recent past it has supported Parent's Association Thalassemic Unit Trust in Mumbai and the Thalassemic Society ofPune and Delhi. Transasia manufactures and markets equipment and reagents, with an impressive install base of around 38,000 equipments across India. Transasia also exports to more than 90 countries in six continents. ]]> <![CDATA[3 GM crops are under field trials: Ms Jayanthi Natarajan]]> https://biospectrumindia.com/news/95/3172/3-gm-crops-are-under-field-trials-ms-jayanthi-natarajan.html https://biospectrumindia.com/news/95/3172/3-gm-crops-are-under-field-trials-ms-jayanthi-natarajan.html Tue, 19 Mar 2013 18:48:40 +0530 Out of 20 genetically modified (GM) crops approved by Genetic Engineering Appraisal Committee (GEAC), three crops such as transgenic cotton, corn and mustard received No Objection Certification (NOC) from state governments nod for conducting field trials in the country. Sharing this information Ms Jayanthi Natarajan, Minister of State (Independent Charge) for Environment and Forests, government of India in the Rajya Sabha in a written reply to a question by Mr K N Balagopal, she said,"The Government has allowed field trial of GM plants in Agriculture sector in India. The GEAC, an apex body notified under Rules 1989 has approved experimental field trials for the purpose of biosafety research and event selection in respect of GM crops such as cotton, rice, tomato, groundnut, potato, corn, sorghum, okra, brinjal, mustard, wheat, watermelon, papaya, sugarcane, rubber, castor, banana, pigeon pea, Artemisia annua L. and Chickpea." She further said, "In respect of other crops, NOC from the State Governments are awaited. Currently there are no ongoing field trials with GM crops. The Government of India is following a policy of case by case approval of GM crops. In view of various concerns related to the safety, efficacy and agronomic performance of transgenic seeds, extensive evaluation and regulatory approval process takes place before any GM plant is approved for commercial cultivation. This includes generation of relevant biosafety information and its elaborate analysis to ensure food, feed and environmental safety. The environmental safety assessment includes studies on pollen escape out- crossing, aggressiveness and weediness, effect of the gene on non-target organisms, presence of protein in soil and its effect on soil micro-flora, confirmation of the absence of terminator gene and baseline susceptibility studies. The food and feed safety studies include assessment on composition analysis, allergenicity and toxicological studies and feeding studies on fish, chicken, cows and buffaloes." "In case, the transgenic crop is not found suitable for release in the environment or human consumption, the product is rejected during the trial stage itself. A final view on the commercialization of GM plants is taken only when there is a clear economic and technical justification for release of the product," the Minister added. ]]> <![CDATA[Efforts are on to contain hepatitis B, says health ministry]]> https://biospectrumindia.com/news/95/3171/efforts-are-on-to-contain-hepatitis-b-says-health-ministry.html https://biospectrumindia.com/news/95/3171/efforts-are-on-to-contain-hepatitis-b-says-health-ministry.html Tue, 19 Mar 2013 16:57:00 +0530 Since April 2005, the Government of India has introduced auto-disabled (AD) syringes for all vaccinations under the Universal Immunization Program (UIP) in all states. AD syringes are single use, self-locking syringes that cannot be used more than once. This prevents misuse and contamination/ cross infection through repeated use of non sterile injection/equipment. The routine screening of blood units for Hepatitis B & C has been made mandatory for all blood banks to detect and discard contaminated blood units. Under the UIP, government of India is providing Hepatitis B vaccine and operational cost of vaccination to states/ UTs for preventing hepatitis B infection. As per the information provided by Union Health Minister, Mr Ghulam Nabi Azad in the Parliament on March 19, 2013, the Universal Immunization Program (UIP) of Government of India is providing hepatitis B vaccine and operational cost of vaccination to states/ UTs for preventing hepatitis B infection. "National Centre for Disease Control (NCDC), under the Ministry of Health and Family Welfare, provides technical guidance to state governments on prevention and control of water borne diseases including hepatitis, and helps them in carrying out investigation of such diseases under Integrated Disease Surveillance Project (IDSP) within the overall framework of National Rural Health Mission (NRHM). NCDC also coordinates laboratory support for outbreak investigations and etiological diagnosis besides conducting regular training courses for development of trained manpower," added the minister. There are five main hepatitis viruses, referred to as types A, B, C, D and E. Hepatitis A and E are typically caused by ingestion of contaminated food or water. Hepatitis B, C and D usually occur as a result of parenteral contact with infected body fluids. Hepatitis B is also transmitted by sexual contact. Since the main cause of Hepatitis A & E is consumption of contaminated water, the Government of India supports state governments/ local bodies in ensuring supply of safe drinking water through National Rural Drinking Water Program (NRDWP) and Jawaharlal Nehru National Urban Renewal Mission (JNNURM). ]]> <![CDATA[India, Spain to cooperate in biotechnology research ]]> https://biospectrumindia.com/news/95/3157/india-spain-to-cooperate-in-biotechnology-research-.html https://biospectrumindia.com/news/95/3157/india-spain-to-cooperate-in-biotechnology-research-.html Mon, 18 Mar 2013 18:18:00 +0530 The objective of the joint Indo-Spanish program is to promote and fund market driven research and technology development as well as to encourage partnerships and business-led research and development for collaborative projects in the field of biotechnology. For this programme, the Department of Biotechnology (DBT), Ministry of Science and Technology, Government of India and the Centre for the Development of Industrial Technology (CDTI), Ministry of Economy and Competitiveness, Government of Spain, are the nodal implementing agencies from the Indian and Spanish side respectively. CDTI is a public entity, which fosters the technological development and innovation of spanish companies. While the call was given on March 15, 2013, the deadline for submission of completed applications is July 15, 2013. The funding decisions are expected to be closed before December 15, 2013. This call for proposals is a generic call open to collaboration in all areas of biotechnology including health biotechnology, industrial biotechnology, nano-biotechnology, agro-biotechnology, including biofuels and bioenergy, bioinformatics and biomedical engineering. The duration of industry-driven and market-oriented R&D projects ranges from 1 year up to 3 years. These joint technological co-operation projects between researchers and companies in India and companies in Spain focus on development or substantial improvement of new products, processes or services. ]]> <![CDATA[Founder of Dr Reddy's Labs is no more]]> https://biospectrumindia.com/news/95/3974/founder-of-dr-reddys-labs-is-no-more.html https://biospectrumindia.com/news/95/3974/founder-of-dr-reddys-labs-is-no-more.html Sat, 16 Mar 2013 08:17:40 +0530 Dr. K. Anji Reddy, Founder & Chairman of Dr. Reddy's Laboratories Ltd., passed away on March 15 in Hyderabad. He was ailing for some time. Under his leadership, the company became a pioneer and trendsetter in the Indian pharmaceutical industry. Dr. Reddy also set-up the "Institute of Life Sciences" at Hyderabad, which is a public-private partnership with the Government of Andhra Pradesh for carrying out cutting edge research in Life Sciences. Critically aware of his own responsibility to society, Dr. Reddy in the last decade was renowned for his outcome based institutionalized philanthropy that positively impacted the lives of nearly 5 million underprivileged citizens, mainly children and youth. In 1998, Dr. Reddy set up the Naandi Foundation as a Public Charitable Trust. Naandi is probably India's largest rural safe drinking water provider, and gives midday meals to 1.3 million government school-going children and farmers. Dr. Reddy took up the cause of safe motherhood and newborn care, thereby reducing maternal and neo-natal care in India. He also spearheaded and founded the Neo Natal Intensive Care and Emergencies called "NICE Foundation", the only institute for newborns in Asia that also does large scale community outreach programs, saving a number of lives on a daily basis. Dr. Reddy's mission in life was to provide innovative new medicines at a price that the common man could afford. His passion for research became legendary when Dr. Reddy's Laboratories Ltd. became the first pharmaceutical company of India to initiate basic drug discovery research in 1993. A B.Sc graduate from Bombay University with specialization in Pharmaceutical Science and Fine Chemicals, Dr. Reddy obtained his Ph.D in Chemical Engineering from National Chemical Laboratory, Pune. Soon after his studies, he served in the state-owned IDPL before he founded the company in 1984. In April 2011, he was honored by the Government of India with the Padma Bhushan, one of the highest Civilian Awards in India, recognizing his distinguished service of high order in the field of Trade and Industry. In 2012, CNBC TV18 conferred the Lifetime Achievement Award (IBLA) on him for being a visionary who had spent a lifetime building up his company into a colossus with a global reach putting Indian industry on the world map. He, who single-handedly built Dr Reddy's Laboratories, founded in Hyderabad, into a power house of pharmaceutical manufacturing also received the BioSpectrum Asia Lifetime Achievement Award in 2010. Dr. Reddy served as a Member of the Prime Minister's Council on Trade & Industry, Government of India. He was the Chairman of Andhra Pradesh Industrial Development Corporation (APIDC), and President of The Indian Pharmaceutical Alliance. He served as a Board Member of GAIN, Switzerland (Global Alliance for Improved Nutrition) and also was on the Board of Directors for TB Alliance, New York (Global Alliance for TB Drug Development). Satish Reddy, MD and COO of Dr. Reddy's Laboratories Ltd and son to Dr. Reddy said: "Dr. Reddy touched millions of lives through his contribution to the Pharmaceutical industry and his Philanthropic efforts. In improving access to affordable, high quality medicines and in innovation, his contributions have been extraordinary. His philanthropic initiatives made a difference in the lives of so many Indians in the areas of livelihood, education, clean drinking water and healthcare. A nation is grateful to a man who paved a way for the delivery of affordable medicines to the masses and made us believe and take pride in innovation as a means to prosperity." ]]> <![CDATA[Glenmark confirms patent challenge for generic Finacea]]> https://biospectrumindia.com/news/95/5550/glenmark-confirms-patent-challenge-for-generic-finacea.html https://biospectrumindia.com/news/95/5550/glenmark-confirms-patent-challenge-for-generic-finacea.html Fri, 15 Mar 2013 15:13:55 +0530 Glenmark Pharmaceuticals, a manufacturer of generic formulation products and active pharmaceutical ingredients (API), has confirmed that it has filed an Abbreviated New Drug Application (ANDA) for Azelaic Acid, Gel 15 percent Topical, with the US Food and Drug Administration (FDA). Glenmark's ANDA product is a generic version of Finacea, which is indicated for the topical treatment of inflammatory papules and pustules of mild to moderate rosacea. Intendis GmbH, Intraserv GmbH and Co, and Bayer Healthcare Pharmaceuticals had filed a suit against Glenmark Generics on March 14, 2013, in the United States District Court for the District of Delaware, seeking to prevent Glenmark from commercializing its ANDA product prior to the expiration of US patent number 6,534,070. This lawsuit was filed under the provisions of the Hatch-Waxman Act, which triggers a stay of final FDA approval of Glenmark's ANDA product for up to 30 months or until final resolution of the matter before the Court, whichever occurs sooner. Based on available information, Glenmark believes it may be a "first applicant" to file an ANDA for the generic version of Finacea and may be entitled to 180 days of generic market exclusivity. According to the IMS health data for the twelve months ending September 30, 2012, Finacea had total US sales of approximately $95 million. ]]> <![CDATA["India and Nepal share close bioagri ties"]]> https://biospectrumindia.com/interviews/95/3170/india-and-nepal-share-close-bioagri-ties.html https://biospectrumindia.com/interviews/95/3170/india-and-nepal-share-close-bioagri-ties.html Fri, 15 Mar 2013 11:52:00 +0530 Tell us about the Nepal Agriculture Research Council (NARC) and its association with Indian agricultural scientists and industry?NARC is the apex body for the applied agricultural research in Nepal. It is the autonomous institute under Ministry of Agriculture Development in Nepal. It was established on 1991; however, the biotechnology unit was established on 1998. NARC-Nepal has close ties with agricultural institutions and scientists all over the world directly and indirectly since its establishment. Since Nepal and India are a part of the South Asian Association for Regional Cooperation (SAARC), it has more relationship with Indian scientists, ICAR and IARI through SAARC and APAARI (Asia Pacific Association of Agricultural Research Institutions). Many capacity building works were conducted by Indian scientists for Nepalese scientists. Nepal Agriculture Research Council helped for the registration of Indian crop varieties developed and marketed by Indian seed companies especially for maize, rice and vegetables. They have the great seed market in Nepal especially for hybrids. Similarly, NARC-Nepal also plays the greater role for the recommendation to Nepalese farmers for the pesticide, fertilizer and machineries produced by Indian companies. Biotechnology Unit alone purchased the biotech chemicals produced by Indian companies (GeiNei, Himedia) costing around $60,000.00 each year. How have the biotechnology applications helped in the growth of agriculture sector in Nepal? Which are the crops that have benefited?Nepal is highly dependent on the agriculture for sustainability of its economy and employment. However, commercialization of the agriculture can't be paced up as expected due to resilience on the application of the modern technology in agriculture. Use of biotechnological tools for the development of the crop varieties is most important. Similarly, adaptation of robust crop varieties developed elsewhere will be another aspect of applications of biotechnology in agriculture. Nepal's physio-geographical situation always favors its main business as agriculture. It lies between two growing economy (India and China) which needs more food for next years. Similarly, it can catch the recent developments in agriculture from its neighboring countries due to its geographical variability that matches to both countries. Hybrid and open pollinated seeds on vegetable crops, maize and rice is popular in Nepal from Indian seed companies that developed using modern technology (except genetic transformation). Nepal has tremendous scope for the development of agricultural sector using modern biotechnology. Very few applications of such technology exist in Nepal. Few initial screening of crop germplasm using molecular markers has been started in some food crops especially on rice, wheat, maize, barley, millets and other underutilized crops recently. Molecular Marker Assisted Breeding/Selection (MAB or MAS) is just initiated for some major crops. However, use of tissue culture for development of disease-free vegetable and fruit crops like potato and banana is already established in private and public sector. Similarly, mushroom seed production is another profit business in Nepal. What kind of funding do you receive from the government? Who are the major contributors and has it been enough?Nepal Agriculture Research Council receives funds from Nepal government and other donors (public funding agencies like World Bank), however, government funding is the major source of funding (it covers 99 percent of total funding) for research and other activities of the institute. Total budget of NARC-Nepal is around $5,000,000 per year for research and another $5,000,000 per year for administration which is distributed all research stations (76 in number) throughout the country. However, it is very insufficient to conduct the research works in all discipline of agricultural research. For example, $80,000 per year is allocated to conduct research works on biotechnology for whole institute, which is insufficient. Does agri-biotech companies exist in Nepal? Provide us details about the product development in agriculture?Yes, some agri-biotech private companies are working in Nepal. Public sector works on research purpose rather than production. Most of private companies (3 in number) are focused on micro-propagation of vegetable, fruit and ornamental plants such as potato, banana, orchid and strawberry. Some have started to work on antibodies and molecular technology for food crops (indigenous fruit, Lapsi and cardamom) (2 in number). Details of the functions of these companies are tabulated as below: Company: R-LabLocation: Sanepa, LalitpurProduct: Production of antibodies, molecular technology on indigenous fruit (Lapsi) Company: Deurali JantaLocation: KathmanduProduct: Molecular technique for virus free cardamom Company: Tissue culture factoryLocation: LalitpurProduct: Tissue culture on potato and orchids Company: Nepal Biotech NurseryLocation: LalitpurProduct: Tissue culture on banana, potato and orchids Company: Himalayan FlorotechLocation: LalitpurProduct: Tissue culture on banana and strawberry What is the status on the GM crops? Are there any chance of commercialization any sooner?There is not any official release and/or registration of genetically modified crops in Nepal to date. The research and release of GMOs in India put the pressure for the adoption of GMOs in Nepal too. Nepalese agriculture sector has a lot of influence from India due to its similar socio-economy context, open boarder and cultural ties. Release of Bt-Brinjal in India develops an alert in Nepalese agriculture because most of the Brinjal seed in Nepal comes from India. Being the signatory country to Cartagena Protocol on Biosafety and Convention on Biodiversity (CBD), Nepal has to develop many rules, regulations and technical capability before adopting any GMOs. As per National Seed Policy-Nepal (1999) Nepal needs a regulatory and monitoring system for conducting research, varietal development and commercial cultivation of GMOs within country. The provision of this system was established on National Biosafety Framework (2007), however, implementation of this framework to develop act, rules and regulations is still not active. Similarly, Nepal still can't develop its technical capability to meet Cartagena Protocol on Biosafety for adoption and/or research on GMOs. Therefore, Nepal doesn't have any chance of adopting genetically modified crops soon owing to its legislation and scientific development aspects. ]]> <![CDATA[India witnesses drop in infant mortality rate]]> https://biospectrumindia.com/news/95/3165/india-witnesses-drop-in-infant-mortality-rate.html https://biospectrumindia.com/news/95/3165/india-witnesses-drop-in-infant-mortality-rate.html Thu, 14 Mar 2013 17:17:57 +0530 There was no increase in infant mortality rate between the period 2003-08. India's infant mortality rate in 2003 was 60 per 1000 live births (SRS 2003) and which has decreased to 53 per 1000 live births (SRS 2008) in 2008. Sharing this information, Mr Abu Hasem Khan Choudhury, Minister of State for Health and Family Welfare, Government of India said, "Government has taken measures under National Rural Health Mission (NRHM) to reduce the infant mortality rate in the country. Besides there are other schemes such as Integrated Child Development Services (ICDS)." Under National Rural Health Mission, the government has taken many steps to reduce infant mortality rate in the country. Some of the programs under the scheme include: Promotion of institutional delivery through Janani Suraksha Yojana (JSY) and Janani Shishu Suraksha Karyakram (JSSK): Promoting institutional delivery to ensure skilled birth attendance is key to reducing both maternal and neo-natal mortality. JSY incentivizes pregnant women to opt for institutional delivery and provides for cash assistance. JSSK entitles all pregnant women to absolutely free and zero expense delivery including caesarean section operation in government health facilities and provides for free transport, food, drugs and diagnostics. Similar entitlements have also been put in place for infants. Strengthening facility-based newborn care: Newborn Care Corners (NBCC) are being set up at all health facilities where deliveries take place to provide essential newborn care at birth to all new born babies; Special New Born Care Units (SNCUs) at district hospitals and New Born Stabilization Units (NBSUs) at FRUs are being set up for the care of sick newborn. As on date 401 SNCUs, 1542 NBSUs and 11508 NBCCs are functional across the country. Home-Based Newborn Care (HBNC):Home-Based Newborn Care through ASHA has recently been initiated to improve new born care practices at the community level and for early detection and referral of sick new born babies. Capacity building of health care providers: Various trainings are being conducted under National Rural Health Mission (NRHM) to build and upgrade the skills of doctors, nurses and ANM for early diagnosis and case management of common ailments of children and care of newborn at time of birth. These trainings include Integrated Management of Neo-natal and Childhood Illness (IMINCI) and Navjaat Shishu Surakshta Karyakaram (NSSK). A total of 5.88 lakh health care workers have been trained in IMNCI in 505 districts and 89,962 health workers in NSSK so far. Management of malnutrition: Emphasis is being laid on reduction of malnutrition which is an important underlying cause of child mortality. 605 nutritional rehabilitation centers have been established for management of Severe Acute Malnutrition (SAM). Iron and Folic Acid are also provided to children for prevention of anaemia. Recently, weekly Iron and Folic Acid distribution has been initiated for adolescent population. As breastfeeding reduces infant mortality, exclusive breastfeeding for first six months and appropriate infant and young child feeding practices are being promoted in convergence with Ministry of Woman and Child Development. Village Health and Nutrition Days (VHNDs) are also being organized for imparting nutritional counselling to mothers and to improve child care practices. Universal Immunization Program (UIP): Vaccination against seven diseases is provided to all children under UIP. Government of India supports the vaccine program by the supply of vaccines and syringes, cold chain equipments and provision of operational costs. UIP targets to immunize 2.7 crore infants against seven vaccine preventable diseases every year. Second dose of Measles has also been incorporated in UIP and pentavalent vaccine has also been introduced in seven states. Year 2012-13 has been declared as 'Year of intensification of Routine Immunization'. Mother and Child Tracking System: A name based Mother and Child Tracking System has been put in place which is web based to enable tracking of all pregnant women and newborns so as to monitor and ensure that complete services are provided to them. States are encouraged to send SMS alerts to beneficiaries reminding them of the dates on which services are due and generate beneficiary-wise due list of services with due dates for ANMs on a weekly basis. In addition to NHRM, the government of India has been making efforts to reduce the infant mortality. Under the ICDS scheme, a self selecting scheme, there are 7,025 operational projects and 13.31 lakh operational Anganwadi Centers (AWCs) in the entire country as on January 2013. Each and every child below six years and pregnant and lactating mothers are eligible and have access to the services under the scheme. However, as the scheme is self-selecting, 927.66 lakh beneficiaries which include 746.81 lakh children (6 months to 6 years) and 180.85 lakh pregnant and lactating mothers (January 2013) have availed the services. Thus as per current reports and calculations, about 55 percent of children under six years are availing the ICDS services. ]]> <![CDATA[Tharoor: If IT can make it happen, why not biotech?]]> https://biospectrumindia.com/news/95/3163/tharoor-if-it-can-make-it-happen-why-not-biotech.html https://biospectrumindia.com/news/95/3163/tharoor-if-it-can-make-it-happen-why-not-biotech.html Thu, 14 Mar 2013 12:00:00 +0530 "New technologies have been always questioned and that has been a regular move from few stakeholders who have certain doubts. Moreover, any new cutting-edge technology will be looked at with doubt. Two decades ago, biotechnology was visibly absent in India and therefore it is the lack of awareness that causes the apprehensions to pop up. So this sector requires distinct efforts to remove the roadblocks and move forward." This was stated by the Union Minister of Human Resources and Development (HRD), Mr Shashi Tharoor at the tenth anniversary celebrations of the Association of Biotechnology Led Enterprises (ABLE), held on March 11, 2013 at New Delhi. Mr Tharoor was appreciative of the efforts being made by the Department of Biotechnology (DBT) in this regard. He further said, "If you want to hire million people by 2020, you need to educate millions today. I am told that DBT is running 140 programs in 70 universities in areas such as nutrition, environment, marine biotechnology, bioentrepreneurship, and bioinstrumentation. The star college scheme for giving aid to small colleges in remote areas has shown very good results. Also the Karnataka model of finishing schools can be followed elsewhere as well. Other states can emulate this model." The HRD minister urged the industry captains to work with government in devising the right curriculum. "Our ministry has to offer incentives. If information technology can makes us proud then why not biotechnology. All we have to do is to give the right kind of attention and nurture it. There is a plenty of room from entrepreneurs to grow in this space and what is required for them are the due facilities," concluded Mr Tharoor. ]]> <![CDATA[ Report: Indian pharma must embrace innovation to stay competitive]]> https://biospectrumindia.com/reports-white-papers/95/4344/-report-indian-pharma-must-embrace-innovation-to-stay-competitive.html https://biospectrumindia.com/reports-white-papers/95/4344/-report-indian-pharma-must-embrace-innovation-to-stay-competitive.html Tue, 12 Mar 2013 12:24:23 +0530 According to a recently released report by the Cambridge Consultants, a global think tank in innovation and high-tech technology consulting firm, the Indian pharmaceutical market today accounts for over 10 percent of global drug production, while ranking among the top five globally by production volume. The pharmaceutical industry continues to be one of India's biggest employers, with more than 340,000 Indian employees dedicated to an industry that is worth in excess of $22 billion. But senior delegates at the Cambridge Consultants Mumbai pharma workshop said that Indian pharmaceutical companies must embrace innovation and adopt technology if they are to stay competitive at both a domestic and global level. In an industry that is extremely competitive, with more than 20,000 pharmaceutical companies, the delegates agreed these were the two main driving forces defining the future landscape of the Indian pharmaceutical industry. The Cambridge Consultant workshop, attended by a cross-section of senior personnel from a variety of functions within leading Indian and multinational companies,explored the question of whether India would become one of the world's leading pharmaceutical countries by 2030. Recent reports suggest India's domestic pharmaceutical sector will grow to $55 billion by 2020. As a significant exporter of high-quality generic drugs, India is expected to see the value of its drug exports double to $25 billion by the end of 2014, according to the country's Minister of Health. The delegate feedback revealed the Indian pharmaceutical industry still has significant growth opportunities, and major local companies could have the potential to compete with multinational pharmaceutical companies. Amongst them, the greatest impact in world markets will come from those Indian pharmaceutical companies which adopt technology innovations to differentiate their products and make them more competitive both domestically and globally. This trend for differentiation is particularly important as Indian pharmaceutical companies have fewer new generic opportunities. This is because the number of New Chemical Entity (NCE) filings to the US FDA has declined over recent years and the number of innovator drug patents reaching their expiry date has peaked. Similarly, at a global level there are more generic pharmaceutical developers from other emerging nations, including China,which will offer low-cost competition for India, as well as the ongoing global threat of counterfeit drugs. Dr Cyrus Karkaria, president of the biotech division at Lupin Pharma India, said, "The Indian pharmaceutical market is really at a very exciting yet challenging point, where it can become an even greater contributor to the Indian economy. Indian pharma companies must remain competitive and look to innovate and adopt technologies that can complement and accelerate the uptake of drugs for better health management."Mr Andrew Barrett, director of medical technology in India at Cambridge Consultants, said, "In order to drive faster growth, and capitalize on their existing success, Indian pharmaceutical companies must now aim to create true added-value offerings with 'super-generics', which can deliver additional benefit to patients. Innovation and technology are key, and the required investments can be recouped because medical products have long lifecycles. Technology has a great role in drug delivery to extend these lifecycles, add value and, importantly, allow product differentiation in a crowded market space." A report based on the discussion stated that technology can play a pivotal role in the Indian pharmaceutical industry as success will be driven by combining drugs with devices and delivery systems, rather than by drugs alone. In addition, Indian pharmaceutical companies could benefit from the following technologies. Firstly, since a growing number of Indian companies are moving into biologics (including biosimilars and biobetters) where injectable therapies necessarily predominate due to the greater difficulty of formulating these drugs for oral administration. Injection technologies, such as auto-injectors and patch pumps,can provide easier and less painful drug administration.Inhaled products are already commonplace in the Indian market through major local and multinational products, targeting respiratory disease markets such as asthma and chronic obstructive pulmonary disease. Indian companies with this pre-existing specialist knowledge are well placed to develop value-added products using the pulmonary route to deliver systemic drugs. When it comes to medical devices, Indian pharmaceutical companies are unlikely to build significant expertise purely in this area. Instead, they could use experienced device design and development consultants to support their significant formulation/chemistry expertise. Indian companies have the opportunity to change manufacturing and production methods to support the further adoption of drug delivery device technologies.Also, against the background of rising healthcare costs, Indian pharma companies can use technology to harvest and beneficially use data to bring benefits to healthcare providers and consumers alike. Given India's dominance in IT and software it isn't beyond belief that a connection could be made between one industry and the other, placing India in a strong position to become a global player in connected health markets. ]]> <![CDATA[Serum Institute starts supplying oral polio vaccine ]]> https://biospectrumindia.com/news/95/4538/serum-institute-starts-supplying-oral-polio-vaccine-.html https://biospectrumindia.com/news/95/4538/serum-institute-starts-supplying-oral-polio-vaccine-.html Mon, 11 Mar 2013 16:48:00 +0530 After staying away from the crowded space of OPV suppliers in India, Serum Institute of India has finally joined the pack, by starting the production of its brand of the vaccine. At the recently organized Vaccine World Summit 2013 in Pune, where SII is situated, Dr Suresh Jadhav, executive director, SII told BioSpectrum that it received a prequalification approval for the oral polio vaccine in February 2013. Today, its supply to UNICEF has already been initiated. While admitting that SII is a late entrant into this space, Dr Jadhav said that other events led them to taking this step. "Since the supply from two other Indian suppliers for the OPV had to be stopped due to some regulatory issues, the UN agencies were facing a shortage of vaccines. We were then asked by the UN agencies to address this issue, and we have now risen to fill in the shortfall." India has not reported a single polio case for the last two years, and is considered to be a model country when it comes to putting a concerted effort for polio eradication. Currently, polio is said to be present in just three countries of the world, namely, Pakistan, Afghanistan and Nigeria.The OPV program is set to be phased out by 2018, after which IPV (Injectible Polio Vaccine) will be administered to infants. This measure is to prevent cases of vaccine derived polio virus. Currently one of the main challenges to using IPV is its cost which is approximately $2.66 per dose, as compared to $0.14 for OPV. A number of manufacturers worldwide are working towards reducing the cost of a single dose of IPV to less than a dollar. At the same event, Dr Cyrus Poonawalla commented that SII would try to offer its brand of IPV at $0.93 per dose. However, the demand for OPV will not die down even then. Dr Jadhav addded that, once the two course OPV administration will be replaced by newer one for IPV, it will still have at at least one dose of OPV. Serum Institute had been adjudged the Number 1 biotech company in the BioSPectrum-ABLE Top 20 Survey conducted in 2012. It had acquired Bilthoven Biologicals in July 2012, and with it gained access to the technical know-how for manufacturing Inactivated Polio Vaccine (IPV). ]]> <![CDATA[Venus gets nod to market Meropenem in Mexico]]> https://biospectrumindia.com/news/95/3059/venus-gets-nod-to-market-meropenem-in-mexico.html https://biospectrumindia.com/news/95/3059/venus-gets-nod-to-market-meropenem-in-mexico.html Mon, 11 Mar 2013 14:16:00 +0530 Venus Remedies has received the grant of market authorization from COFEPRIS, the Drug Regulatory Authority of Mexico, for its Meropenem 500mg and Meropenem 1000mg in Mexico. The Panchkula (Haryana) headquartered company is now planning to launch the product in Mexico in the first quarter of fiscal year 2013-14. According to the company statement, this grant from COFEPRIS, Latin America's most stringent regulatory authority, is further endorsement to Venus Remedies' R&D capabilities and its expertise in developing world class products. Market authorization for Meropenem will enable Venus Remedies to launch its first product in Mexico and will strengthen its position in Latin America where Venus is currently exporting to various countries such as Columbia, Peru, Guatemala, Dominican Republic, Jamaica, Bahamas and the Caribbean. Commenting on this achievement, Mr Dheeraj Aggarwal, chief financial officer, Venus Remedies said, "Grant of market authorization at this point of time when the innovator's product has already gone off patent is going to be an advantage for us. We are hopeful of capturing 10 percent of the market share within the first three years of our product launch." At present, Meropenem sales account for $16.3 million in Mexico, of which, major share of 80 percent is with innovator's product "MERREM" and rest with other local companies. Venus Remedies with its dedicated penems EU GMP certified manufacturing facility in Baddi, India, is all set to expand its footprints across the globe. It already has 73 marketing authorizations for Meropenem across the world while product registrations from 13 countries are under process and are expected within this year only. Meropenem is a broad spectrum anti-bacterial agent of carbapenem family, indicated as empirical therapy prior to the identification of causative organisms, or for disease caused by single or multiple susceptible bacteria in both adults and children with multiple serious infections including bacterial meningitis, nosocomial pneumoniae, septimicemia, serious ICU infections, intraabdominal infections, febrile neutopenia, skin and skin structure infections. It is also very resistant to extended-spectrum beta lactamases. ]]> <![CDATA[Azad: No spurious drug imported since 2010]]> https://biospectrumindia.com/news/95/6490/azad-no-spurious-drug-imported-since-2010.html https://biospectrumindia.com/news/95/6490/azad-no-spurious-drug-imported-since-2010.html Mon, 11 Mar 2013 12:51:56 +0530 The imported cases of spurious and sub-standard drugs on the notice of the government during the last three years and the current year have decreased considerably. The information to this effect was provided by the Minister for Health and Family Welfare, Mr Ghulam Nabi Azad in the parliament on March 08, 2013. The health ministry data has revealed that during 2009-10, the spurious drugs reported were seven in number. At the same time, the sub-standard drugs were 35, which continued to be the same in 2010-11. Again in 2011-12, 34 drugs were found to be sub-standard. During 2013, there were 18 cases of such drugs reported as sub-standard. Between 2010 to early 2013, there was not a single case of spurious drugs that was reported in the country. The first meeting of the Member State Mechanism (MSM) on Sub-standard/Spurious/Falsely-labeled/Falsified/Counterfeit (SSFFC) medical products met from November 19-21, 2012 in Buenos Aires. The meeting decided to establish an open-ended working group to identify the actions, activities and behaviors that result in SSFFC medical products. In order to actively participate in the working group, the Ministry of Health and Family Welfare set up a cell comprising three experts in the Indian Pharmacopoeia Commission on January 15, 2013 to address the issues pertaining to strengthening international cooperation for harmonization of practices on SSFFC. "The quality of the drugs imported into the country is regulated under the provisions of the Drugs and Cosmetics Act, 1940 and Rules made there under, through a system of registration, import license and checking of the consignments at the time of their import at the designated ports. Drugs found spurious and sub-standard are not permitted to be released for import by the customs authorities. The cases of import of spurious drugs in 2009-10 were investigated by the Central Bureau of Investigation (CBI) and prosecutions launched on the basis of evidences available as per the provisions of law," said the minister. ]]> <![CDATA[Strong drug regulators needed for strong health systems]]> https://biospectrumindia.com/news/95/3478/strong-drug-regulators-needed-for-strong-health-systems.html https://biospectrumindia.com/news/95/3478/strong-drug-regulators-needed-for-strong-health-systems.html Mon, 11 Mar 2013 10:50:57 +0530 Among the various steps taken to strengthen the regulatory institution, the Union Health Ministry has created 216 additional posts in Central Drugs Standard Control Organization (CDSCO) since 2008. The Central Drugs Testing Laboratories have been provided new sophisticated testing equipment. Two sub-zones of CDSCO (Hyderabad and Ahmedabad) have been upgraded to full zones and three new sub-zones (Bangalore, Chandigarh and Jammu) have been created. Besides this, the scheme of regular overseas inspection of manufacturing facilities situated abroad has been initiated to ensure proper compliance of good manufacturing practices guidelines before registering them for import of drugs. Two such inspections have already taken place in China. The National Pharmacovigilance Program has been launched to capture Adverse Drugs Reactions (ADRs) for safe-guarding public health. 60 ADR Monitoring Centers are already functioning besides the National Coordination Center at the Indian Pharmacopoeia Commission, Ghaziabad (UP) and a Pharmacovigilance Cell at CDSCO headquarters. According to the information provided by Minister for Health and Family Welfare, Mr Ghulam Nabi Azad in the parliament on March 08, 2013, "The state governments have also been requested to strengthen their manpower and infrastructure. On its part, the central government has been extending financial assistance to them for upgradation of their infrastructure under the National Rural Health Mission. Further, during the 12th Five Year Plan, it has initiated a new scheme for providing financial assistance to the states/ UTs for strengthening of State Drug Control Departments." The quality of drugs, whether generic or non-branded or branded manufactured or imported for sale in the country is regulated under the provisions of the Drugs and Cosmetic Act, 1940 and the Drugs and Cosmetic Rules, 1945. Under these laws, the manufacture and sale of drugs are regulated by the state governments and the import, approval of new drugs and banning of drugs are regulated by the central government through CDSCO. ]]> <![CDATA[India has no accurate data of genetic disorders ]]> https://biospectrumindia.com/news/95/3133/india-has-no-accurate-data-of-genetic-disorders-.html https://biospectrumindia.com/news/95/3133/india-has-no-accurate-data-of-genetic-disorders-.html Mon, 11 Mar 2013 10:13:00 +0530 "No country-wide or state-wise data on genetic conditions is maintained by the government of India. Also, the government has no specific strategy for genetic counselling and treatment for genetic diseases." This was stated by the Minister of State for Health and Family Welfare, Mr Abu Hasem Khan Choudhury while replying to a query raised in the parliament on March 08, 2013. The minister while referring to certain figures collected by the Indian Council of Medical Research (ICMR) also mentioned, "However, as reported by ICMR, there may be 1 lakh thalassemics and the same number of sickle cell disease patients and about 65,000 cases of haemophilia in India. It is estimated that about 10,000 new thalassemia cases, 8,000 new sickle cell anemia patients and 5,000 new haemophilia patients are born each year in India." The minister also highlighted the various initiatives taken by the ICMR in this direction. Among these are the carrying out of National Task Force studies on hemoglobinoapthies. Again the micro and macro epidemiologic data on these diseases has been developed. ICMR has helped to set up prenatal diagnostic facilities for haemoglobinopathies in five centres in the country in the states of Maharashtra, Gujarat, West Bengal, Karnataka and Punjab. The proper record of genetic disorders can certainly be beneficial for the researchers and the medical practitioners in the long run. With the government itself admiting the lack of such database, the time is right is to have coordinated efforts from all the stakeholders to create it as soon as possible. ]]> <![CDATA[Govt steps in to control cancer drug prices ]]> https://biospectrumindia.com/news/95/3129/govt-steps-in-to-control-cancer-drug-prices-.html https://biospectrumindia.com/news/95/3129/govt-steps-in-to-control-cancer-drug-prices-.html Fri, 08 Mar 2013 14:02:00 +0530 As per IMS Health data available with National Pharmaceutical Pricing Authority (NPPA), the details of Nexavar which is an anti-cancer drug are not reported. In respect of drugs not covered under the Drugs (Prices Control) Order, 1995 (DPCO, 1995) i.e. non-scheduled drugs, manufacturers fix the launch prices by themselves without seeking the approval of Government/NPPA. Anti-cancer medicines are non-scheduled drugs. Under the present framework of price fixation, there are no controls on the launch prices of non-scheduled medicines. Speaking in the parliament on March 7, 2013, Mr Srikant Kumar Jena, Minister of State for Chemicals and Fertilizers mentioned, "It has been informed by the Department of Industrial policy and Promotion that Natco Pharma had applied to the Controller General of Patents Design and Trade Marks (CGPDTM) in July, 2011 for grant of compulsory license for the drug "Sorafenibtosylate" patented by Bayer under Section 84 of the Patents Act, 1970. The Controller General Patents Design and Trade Marks, after examining the application, granted the compulcory license to Natco Pharma in March, 2012. However, Bayer filed an appeal before IPAB (Intellectual Property Appellate Board) against the said orders of the CGPDTM." There is no classification of life saving drugs in DPCO, 1995. Recently, the Government has notified the New Pharmaceutical Pricing Policy, 2012 (NPPP-2012) on December 7, 2012. NPPP-2012 provides for price fixation of cancer drugs specified in the National List of Essential Medicines-2011 (NLEM-2011) of the prescribed strengths and dosage forms. As envisaged in the NPPP-2012, prices of these specified anti-cancer drugs would be fixed after promulgation of the new DPCO by the government. Further, to bring down the prices, Ministry of Health and Family Welfare has recommended three cancer drugs, namely, Trastuzumab, Ixabepilone and Dasatinib to the Department of Industrial Policy and Promotion to put them under compulsory licensing under the provisions of the Indian Patents Act, 1970. ]]> <![CDATA[Delhi reports 834 confirmed cases of Influenza A H1N1]]> https://biospectrumindia.com/news/95/3128/delhi-reports-834-confirmed-cases-of-influenza-a-h1n1.html https://biospectrumindia.com/news/95/3128/delhi-reports-834-confirmed-cases-of-influenza-a-h1n1.html Thu, 07 Mar 2013 18:17:31 +0530 Cases of Influenza A H1N1 have been reported from Rajasthan, Delhi, Punjab, Haryana, Chandigarh, Gujarat and Madhya Pradesh since January 1, 2013. 834 laboratory confirmed cases have been reported as on February 26, 2013 in National capital territory of Delhi. Giving details on the situation on Influenza A H1N1 in the Rajya Sabha, Mr Ghulam Nabi Azad, Union Minister for Health and Family Welfare said, "The ministry has provided guidelines on screening and categorization of patients, laboratory diagnosis, infection control, home care and clinical management. The drug Oseltamivir available with the Central Government has been supplied, as per requisition, to the states. This drug can also be procured by the states locally. Technical support is provided for surveillance through Integrated Disease Surveillance Program." The minister further said, "To facilitate laboratory diagnosis through a network of 26 laboratories in government sector, in addition to the earlier support given for strengthening these laboratories, support for diagnostic reagents for diagnosis of Influenza A H1N1 is being given. Personal protective equipment, surgical masks and N-95 masks have also been provided. States have been addressed to increase awareness among public for adopting simple public health measures such as hand washing, covering the mouth while coughing, sneezing and avoiding crowded places." ]]> <![CDATA[Govt promotes organic farming by providing incentives]]> https://biospectrumindia.com/news/95/5490/govt-promotes-organic-farming-by-providing-incentives.html https://biospectrumindia.com/news/95/5490/govt-promotes-organic-farming-by-providing-incentives.html Thu, 07 Mar 2013 18:15:14 +0530 Demand for organic food items is on the rise during the last few years. Organic products are costlier in the country due to demand by consumers for chemical residue free food grown by nature friendly methods without the use of synthetic inputs. Considering the opportunity, government is promoting production of organic crops, fruits and vegetables through various schemes viz National Horticulture Mission (NHM), Horticulture Mission for North East and Himalayan States (HMNEH), Rashtriya Krishi Vikas Yojana (RKVY), National Project on Management of Soil Health and Fertility (NPMSHF), National Project on Organic Farming (NPOF), Network Project on Organic Farming under Indian Council of Agricultural Research (ICAR) and various schemes of Agricultural and Processed Food Products Export Development Authority (APEDA). India produced around 3.88 million metric tons of certified organic products which includes all varieties of food products namely basmati rice, pulses, honey, tea, spices, coffee, oil seeds, fruits, processed food, cereals, herbal medicines and their value added products. The production is not limited to the edible sector, but also produces organic cotton fiber, garments, cosmetics, functional food products, and body care products. Currently, India ranks 33rd in terms of total land under organic cultivation and 88th position for agriculture land under organic crops to total farming area. The cultivated land under certification is around 4.43 million hectares ( 2010-11). "There is no provision of Minimum Support Price (MSP) in respect of organic farm produce. However, the government is promoting organic farming by providing incentives to cultivators of organic food products under the NHM at Rs 10,000 per hectare for maximum area of four hectare per beneficiary, setting up of vermicompost unitsat 50 percent of the cost, subject to a maximum of Rs 30,000 per beneficiary and organic farming certification at Rs 5 lakh for group of farmers covering an area of 50 hectare. Assistance for organic food promotion is also available under Rashtriya Krishi Vikas Yojana (RKVY) for projects formulated and approved by the state level sanctioning committee," said Mr Tariq Anwar, Minister of State for Agriculture and Food Processing Industries, Government of India. India exported 86 items in 2010-11 with the total volume of 69,837 metric tons. The export realization was around $157.22 million registering a 33 percent growth over the previous year. Organic products are mainly exported to Europe, US, Australia, Canada, Japan, Switzerland, South Africa and Middle East. Oil Crops (except Sesame) leads among the products exported (17966 metric tons). ]]> <![CDATA[Agri minister calls for adoption of farmer friendly technologies ]]> https://biospectrumindia.com/news/95/6796/agri-minister-calls-for-adoption-of-farmer-friendly-technologies-.html https://biospectrumindia.com/news/95/6796/agri-minister-calls-for-adoption-of-farmer-friendly-technologies-.html Thu, 07 Mar 2013 18:09:51 +0530 Agriculture and Food Processing Industries Minister, Mr Sharad Pawar, called for introduction of innovative farm technologies that could be easily adopted by the farmers and are essential for enhancing farmer's prosperity . While inaugurating the Krishi Vigyan Mela at Indian Agricultural Research Institute (IARI), New Delhi the minister said, "Adoption of appropriate and farmer friendly technologies has remained the weakest link in Indian Agriculture and I hope, with organizing Vigyan Melas like this we will be able to address this gap." The minister further said, "The key to success of agriculture lies in transferring the knowledge and technologies developed by the agricultural scientists in their laboratories to the farming communities in their fields." He further added that due to hard work of our farming community, India's agriculture sector has emerged as a success story. "We have not only achieved self sufficiency in the food grains production, but also emerged as a major player in the international trade. Our export of wheat and rice ensured that the international prices of these commodities remain stable. Last year we exported agriculture commodities worth Rs.1.87 lakh crore," he said. Expressing his view that the problems of agriculture productivity like water scarcity, small land holdings, erratic monsoon, adverse drought conditions have to be addressed, he said, "The Government of India is doing its best to solve these problems through various programmes and schemes targeted to the agricultural and allied sectors. However, all agricultural research, development and extension organizations must come together to meet these challenges and convert them into opportunities. I see no reason why we cannot overcome these challenges." ]]> <![CDATA[Elder Pharma forms JV with Japanese cosmetic firm]]> https://biospectrumindia.com/news/95/4713/elder-pharma-forms-jv-with-japanese-cosmetic-firm.html https://biospectrumindia.com/news/95/4713/elder-pharma-forms-jv-with-japanese-cosmetic-firm.html Wed, 06 Mar 2013 17:51:08 +0530 Elder Pharmaceuticals, a Mumbai-based pharmaceutical manufacturing and marketing organisation announced that it will be creating a joint venture with KOSE Corporation of Japan for manufacturing, selling and distribution of Cosmetics Product in India. The new entity will be known as Kose Elder (India). KOSE will be holding 60 percent while the Elder Pharmaceuticals will hold remaining 40 percent in the new venture. By virtue of its strategic alliances, synergetic acquisitions globally accredited manufacturing facilities and above all an extensive marketing and distribution network, Elder Pharma is one of the fastest growing pharma companies in India with revenue of Rs 981.89 crore for the year ended March 2012. Elder Pharmaceuticals in December last year has signed an agreement with Russia's Holding PharmaEco for bilateral co-operation in the healthcare sector. KOSE Corporation is a company engaged in the manufacture and sale of cosmetics and applied products in Japan and other countries. The makeup segment is engaged in the manufacture and sale of makeup products under the brand names KOSE, BEAUTE de KOSE, COSME DECORTE, Predia, INFINITY, AWAKE, JILLSTUART, CLIE, PHILNATURNT and ALBION, among others. The cosmetary segment is engaged in the manufacture and sale of cosmetary products under the brand names Fasio, HAPPY BATH DAY, ELSIA, STEPHEN KNOLL COLLECTION, SALON STYLE and others. The others segment is engaged in the purchase and sale of products under the name BIBALANCE, the manufacture and sale of amenity products, the leasing of real estate properties, the manufacture and export of materials, as well as the original equipment manufacturing (OEM) business. ]]> <![CDATA[Agila receives FDA approval for Zoledronic Acid]]> https://biospectrumindia.com/news/95/5914/agila-receives-fda-approval-for-zoledronic-acid.html https://biospectrumindia.com/news/95/5914/agila-receives-fda-approval-for-zoledronic-acid.html Wed, 06 Mar 2013 17:43:10 +0530 Agila Specialties, a wholly owned subsidiary of Strides Arcolab (Strides) received ANDA approval for Zoledronic Acid Injection 4 mg (base)/5 ml, packaged in single dose vials. According to IMS data, the US market for Zoledronic Acid 5ml approximately $520 million. The product is expected to be launched shortly. Zoledronic Acid is used to treat high blood calcium levels (hypercalcemia) that may occur with cancer. Zoledronic acid is also used with cancer chemotherapy to treat bone problems that may occur with multiple myeloma and other types of cancer (such as breast, lung) that have spread to the bones. Agila, Specialties business of Strides Arcolab is focused on key domains such as oncolytics, penems, pencillins, cephalosporins, ophthalmics, peptides and biosimilars and operates from nine world-class global manufacturing facilities, including one of the largest steriles capacity in India and amongst the largest lyophilization (freeze drying) capacities in the world. Agila's marketing network covers 70 countries and it has partnerships with some of the world's leading pharmaceutical companies for both developed and emerging markets. ]]> <![CDATA[Govt has no plans to set up Biosafety Institute]]> https://biospectrumindia.com/news/95/4847/govt-has-no-plans-to-set-up-biosafety-institute.html https://biospectrumindia.com/news/95/4847/govt-has-no-plans-to-set-up-biosafety-institute.html Wed, 06 Mar 2013 16:58:12 +0530 The Government of India has no plans to set up an independent Biosafety institute to test the harmful effects of Genetically Modified (GM) crops that are imported or developed in the country. Sharing this information in the Rajya Sabha, Ms Jayanthi Natarajan, Minister of State (Independent Charge) for Environment and Forests, Government of India said, "There are several reputed institutions in India that have the capability of conducting biosafety assessment." The minister further said, "However, there is a proposal to establish an independent "Biotechnology Regulatory Authority of India (BRAI)" for the regulation of GM Crops through an Act of Parliament, to promote the safe and responsible use of modern biotechnology by enhancing the effectiveness and efficiency of regulatory procedures including the testing of GM crops for harmful effect, if any. The BRAI Bill has been submitted to Lok Sabha Secretariat for introduction by the Department of Biotechnology." ]]> <![CDATA[No wild polio-virus case identified in India for over 2 years ]]> https://biospectrumindia.com/news/95/2972/no-wild-polio-virus-case-identified-in-india-for-over-2-years-.html https://biospectrumindia.com/news/95/2972/no-wild-polio-virus-case-identified-in-india-for-over-2-years-.html Wed, 06 Mar 2013 15:55:00 +0530 Addressing the 5th Foundation Day of the Post Graduate Institute of Medical Education & Research, Dr Ram Manohar Lohia Hospital (RML PGIMER), New Delhi, Mr Ghulam Nabi Azad, Union Minister of Health & Family Welfare, Government of India said that with a phenomenal increase in institutional deliveries, from about 700,000 in 2005-06 to over 10,000,000 every year for the past two years, the available infrastructure has been stretched to meet the demand. More than 25,000 additional beds have been sanctioned in 415 health facilities in 11 states across the country to meet the demand this year. Latest initiative is the Rashtriya Bal Swasthya Karyakram, which was launched on February 6, 2013 from a tribal block of Thane District in Maharashtra. This national programme is for Universal Screening of Children for Disorders, Diseases, Deficiencies and Disabilities from birth up to 18 years. The programme will cover about 270 million children across the country. He said, "India made rapid stride in the field of medical education in the recent years. In just over three years' time, the availability of MBBS seats went up from 33,567 to 45,629 and the number of PG seats increased from 13,838 to 22,850. 72 new medical colleges, including six All India Institute of Medical Sciences (AIIMS) , were established raising the number from 290 to 362. The Medical Colleges at the six new AIIMS have started functioning with admission of 50 students each in September, 2012. To strengthen Tertiary Health Care delivery in the government sector, Government of India took up 19 State Government owned medical colleges for up-gradation under the Pradhan Mantri Swasthya Surakhsha Yojana in different parts of the country. Significant achievements have been made under National Rural Health Mission (NRHM). About 43,500 new health infrastructure works have been created and nearly 1.45 lakh human resources added at various levels. About 70,000 increase in bed capacity to provide essential and emergency services, which have all helped in bringing healthcare services to all, especially to the marginalized and vulnerable sections living in rural, remote and difficult to access areas." Mr Azad further said, "RML PGIMER has provided quality education and training to the graduates in medical sciences to make them specialists of the future. This effort of producing specialist doctors at RML is part of national effort to augment human resources in health to give the manpower for national programmes and initiatives. The Director, Doctors and Staff of the RML Hospital have played a leading role and responded effectively to the H1N1 outbreaks whenever they have occurred. We have tackled the situation by increasing the number of labs for testing from 2 to 46 at present. In August, 2010, the WHO declared that H1N1 had moved into post-pandemic phase, but also observed that there would be sporadic outbreaks in some countries, including India. It is a matter of great satisfaction that at that time DG WHO showcased India along with New Zealand as a model for other countries in terms of vigilance, quick detection and treatment and recommended vaccination in the immediate post-pandemic period. We have since had outbreaks during August 2010 to October 2010 and May 2011 to July 2011 and January 2012. We have now adequate preparation with regard to surveillance, testing and treatment of H1N1." ]]> <![CDATA[Ranbaxy enters into marketing alliance with Alembic ]]> https://biospectrumindia.com/news/95/6932/ranbaxy-enters-into-marketing-alliance-with-alembic-.html https://biospectrumindia.com/news/95/6932/ranbaxy-enters-into-marketing-alliance-with-alembic-.html Wed, 06 Mar 2013 15:42:00 +0530 Ranbaxy Pharmaceuticals, a wholly owned subsidiary of Ranbaxy Laboratories, has entered into an in-licensing agreement with Alembic Pharmaceuticals Ltd (APL) to exclusively market Desvenlafaxine Base Extended Release Tablets in the US healthcare system. APL is the sponsor and manufacturer of the New Drug Application (NDA) Desvenlafaxine Base Extended Release Tablets. The product is a bioequivalent version of innovator drug, Pristiq by Pfizer.The market size for Pristiq is $590 million (IMS - MAT January 2013). Desvenlafaxine Base Extended Release Tablets is indicated for the treatment of major depressive disorder. The product will be available in 50 mg and 100 mg dosage strengths. Alembic has received the final approval from the US Food and Drug Administration (USFDA) and Ranbaxy expects the product to be available in the US marketplace during the first quarter of 2013. Commenting on the development, Mr Bill Winter, vice president, Ranbaxy Trade Sales and Distribution, North America said, "Ranbaxy is pleased to partner with Alembic to offer a safe, effective, affordable generic alternative to the brand formulation much ahead of the patent expiration. We are committed to expand our portfolio of products offered in the US market for the benefit of patients, prescribers and the US healthcare system." ]]> <![CDATA[Bharat Biotech's RotaVac completes phase III trials]]> https://biospectrumindia.com/news/95/8066/bharat-biotechs-rotavac-completes-phase-iii-trials.html https://biospectrumindia.com/news/95/8066/bharat-biotechs-rotavac-completes-phase-iii-trials.html Wed, 06 Mar 2013 15:25:09 +0530 Vaccine World Summit, which is happening in Pune, aims to provide a meeting platform for leading vaccine players to explore partnership opportunities at various stages of the vaccine lifecycle, from the earliest basic research to licensure of the vaccine. In the keynote address by Dr TS Rao, advisor, Department of Biotechnology (DBT), Ministry of Science and Technology, Government of India, highlighted some of the developments that are happening in the vaccine space in India. RotaVac, India's first indigenously developed rotavirus vaccine is being developed by Bharat Biotech along with institutions such as DBT, Gates Foundation, Program for Appropriate Technologies in Health (PATH), Centers for Disease Control, USA, National Institutes of Health - National Institute of Allergy and Infectious Diseases (NIAID), USA, Society for Applied Studies, Translational Health Sciences Technology Institute, Indian Institute of Science, All India Institute of Medical Science, and Stanford University. Dr Rao announced at the summit that phase III trials for this rotavirus vaccine has been done on 6,800 subjects at three locations; SAS Delhi, CMC Vellore, and KEM Mumbai and now the data is being analyzed for the same. It may be recalled that Dr Krishna Ella, chairman and MD, Bharat Biotech in 2011 had announced that Rotavac would be available at a price of $1 a dose. The vaccine expects India licensure during 2014 and WHO prequalification in 2015 for supply to UN agencies. Praising the effort of this public-private partnership, Dr Rao mentioned, "This is the best model for vaccine development and a perfect PPP model. Seeing the efficiency of RotaVac project, similar model has been adopted for malaria vaccine development." He further said that "One of the challenges in vaccine space is clinical trials of new vaccines. DBT is closely working with DCGI to solve this issue regarding clinical trials." India's vaccine market stands at $260 million at the moment. According to CDC estimates, rotavirus causes approximately 352,000-592,000 deaths each year in children below the age of five. ]]> <![CDATA[Vaccine World Summit kicks off today in Pune]]> https://biospectrumindia.com/news/95/8351/vaccine-world-summit-kicks-off-today-in-pune.html https://biospectrumindia.com/news/95/8351/vaccine-world-summit-kicks-off-today-in-pune.html Tue, 05 Mar 2013 13:11:03 +0530 The Vaccine World Summit kicks off today in Pune. Into its 3rd year of running, the Vaccine World Summit India will provide a meeting platform in India from 5-7 March 2013 for leading vaccine industry players to explore partnership opportunities at various stages of the vaccine lifecycle, from the earliest basic research, extends through licensure to all dimensions of the vaccine production. As India shifts from being a low cost generic vaccine suppliers into R&D power house, local vaccine manufacturers seek to fast track and gain greater access to the latest vaccine technologies through global partnerships. In the recent years, there is a significant rise in global partnerships where international and local vaccine players come together to learn and complement one another's capabilities.Upon the launch of the first Japanese Encephalitis vaccine in India, a collaborative effort, manufactured by Biological E based on Interncell's technology, Thomas Linngelbach, CEO of Intercell commented that the strategic partnership is vital in this remarkable success. Dr Modi, Chairman of Cadila Pharmaceuticals also attributed the exceptionally speedy progress of their new vaccine development to their Joint Venture with Novavax, while Stanley Erck, President and CEO of Novavax trust that the collaboration will expand Novavax's vaccine development capability and add to their global manufacturing capacity. According to the organizers of the event, IMAPAC, the Indian vaccine industry, valued at $350 million in 2011, is expected to significantly expand, reaching the size of $871million by 2016.As the global vaccine industry landscape shift towards India, the Indian government sees the need to make unprecedented changes to the growing industry. In 2009, the Indian government has declared 2010-2020 as the "Decade of Innovations", promoting innovations in the health care sector through various schemes. Featured speakers will include Dr Suresh Jadhav, Executive Director, Serum Institute;Dr Rajiv Indravadan Modi, Managing Director, Cadila Pharmaceuticals;Dr Inderjit Singh Sarao, Associate Director, Merck, USA; Dr James F. Young, Chairman, Novavax, USA; Dr Harish Iyer, CEO, Shantha Biotechnics;Dr Norman Baylor, Advisor, PATH MVI Vaccine Science Portfolio Advisory Council (VSPAC), USA; Dr Ranga Iyer, Advisor, Indian Health Progress & Global Pharma Associations;Tarun Vij, Country Program Leader, PATH , India; Dr Stanley Erck, President and CEO, Novavax, USA;Dr Anand Kumar, Deputy Managing Director, Indian Immunologicals; Dr V. Krishna Mohan, Executive Director, Bharat Biotech International;Dr SD Ravetkar, Executive Director, Serum Institute;Dr Reinhard Glueck, Chief Scientific Officer, Zydus Cadila; Dr Shirshendu Mukherjee, Strategic Advisor, Wellcome Trust, India; Dr Davinder Gill, Chief Executive Officer, MSD Wellcome Trust Hilleman Laboratories; Dr Ramesh S. Paranjape, Director, National AIDS Research Institute, India; Dr Vipin Vashishtha, Convener, Indian Academy of Pediatrics - Committee on Immunization; Helen Yang, Business Development Director, Sinovac Biotech, China; Dr Sanjay Singh, Chairman, Gennova Biopharma; Dr Jacqui Shea, General Manager, Oxford-Emergent Tuberculosis Consortium, UK; Abdul Muktadir, Managing Director, Incepta, Bangladesh; Dr Rajendra Jani, Senior Vice President of Clinical R&D, Cadila Healthcare, India and Prof T Jacob John, Virologist, Christian Medical College in Vellore, WHO Committee Global Polio Eradication, India ]]> <![CDATA[Dr. Reddy's now holds 98.6% of the shares in OctoPlus]]> https://biospectrumindia.com/news/95/1620/dr-reddys-now-holds-98-6-of-the-shares-in-octoplus.html https://biospectrumindia.com/news/95/1620/dr-reddys-now-holds-98-6-of-the-shares-in-octoplus.html Mon, 04 Mar 2013 13:12:22 +0530 With reference to the joint press releases of Dr. Reddy's and OctoPlus issued on 22 October 2012, 13 December 2012 and 12 February 2013 respectively, the offeror (Reddy Netherlands, a wholly owned subsidiary of Dr. Reddy's Laboratories) and OctoPlus hereby jointly announced that the offeror holds 98.6% of the Shares after the Post Closing Acceptance Period The acquisition of shares by the offeror pursuant to the offer and outside the offer will, among other things, reduce the number of shareholders and the number of shares that might otherwise be traded publicly, and (i) will thus adversely affect the liquidity and (ii) may affect the market value of the remaining shares. As a result of the acquisition of more than 95% of the shares by the offeror, the offeror and OctoPlus will jointly request NYSE Euronext Amsterdam to terminate the listing and trading of the Shares on NYSE Euronext Amsterdam as soon as possible. As long as the shares remain listed on Euronext Amsterdam, OctoPlus shall continue to comply with the Dutch Corporate Governance Code except for (i) current deviations from the code and (ii) deviations from the code that find their basis in the merger protocol, in accordance with the "explain" requirement in respect of such deviations. In the event that OctoPlus or any merging entity will no longer be listed and its shares will no longer be publicly traded, the provisions applicable to the governance of listed companies will no longer apply and the rights of remaining minority Shareholders may be limited to the statutory minimum. ]]> <![CDATA[TCS adjudged a leader in life science drug safety services]]> https://biospectrumindia.com/news/95/1098/tcs-adjudged-a-leader-in-life-science-drug-safety-services.html https://biospectrumindia.com/news/95/1098/tcs-adjudged-a-leader-in-life-science-drug-safety-services.html Sat, 02 Mar 2013 11:48:29 +0530 Tata Consultancy Services (TCS), a leading IT services, consulting and business solutions organization, announced that it has been designated as a leader in life science drug safety services (DSS) by the prominent global market intelligence firm, IDC. Among the attributes that earned TCS its leadership position in the "IDC MarketScape: Worldwide Life Science Drug Safety Services 2013 Vendor Assessment" are the company's significant industry expertise, strong drug safety IT and KPO delivery capabilities and investment in drug safety specific IP assets. IDC MarketScape reports are designed to identify factors conducive to success in a particular market, both long term and short term, and then assess vendors participating in the market against these factors. The criteria for each IDC MarketScape report is developed by IDC analysts and can include discussions, surveys and interviews. For this report, the key criteria for defining excellence included; breadth of service offerings, diversity of resources and infrastructure-supporting services delivery, project experience in the Life Sciences DSS outsourcing market, customer service strategy and customer satisfaction, pricing model, go-to-market capabilities and commitment to growth and innovation in the R&D DSS space. The report's author, Dr. Alan S. Louie, research director, Clinical Development Strategy and Technology, IDC Health Insights says, "TCS' large life science customer base, broad industry-centric services portfolio, competitive pricing, and strong commitment to growth ensure that the company will continue to be a leading service provider to the industry over both the near and long term." Debashis Ghosh, president, Life Sciences, Manufacturing and Energy at TCS said, "For TCS and our life sciences customers, patient safety is the absolute priority and we are honored to be listed as a Leader by IDC Health Insights in the Drug Safety market. This recognition is a testament to our commitment to our customers, of constantly innovating and delivering superior drug safety services, and helping companies in ensuring enhanced care for their patients." TCS' drug safety services help customers enhance efficiency, reduce costs significantly and ensure regulatory compliance. ]]> <![CDATA[Union Budget 2013: A major boost to bioagri]]> https://biospectrumindia.com/news/95/1093/union-budget-2013-a-major-boost-to-bioagri.html https://biospectrumindia.com/news/95/1093/union-budget-2013-a-major-boost-to-bioagri.html Sat, 02 Mar 2013 11:36:06 +0530 Giving a boost to agriculture in the country, the Union Finance Minister Mr P Chidamabaram announced $4.9 billion (Rs 27,049 crore) for the Ministry of Agriculture, which is a 22 percent increase on the current allocation for the sector. The announcement has raised the hopes in the agribiotechnology sector, especially in the eastern states of the country, as emphasis will be on crop diversification and innovation to drive a green revolution. As part of its 'look east' policy, the government has proposed a $184 million (Rs1,000 crore) allocation for agriculture in the eastern states in 2013-14. Mr Chidambaram, who presented the Union Budget of India for the second time as the finance minister, informed parliament members that the government will establish an Indian Institute of Agricultural Bio-technology at Ranchi in Jharkhand, an eastern state of India. The institution will serve as a center of excellence in agricultural biotechnology. Schools proposed under the institution, which will be a deemed university, will lead research in genomics, bioinformatics, genetic engineering, nano biotechnology, diagnostics and prophylactis and basic and social sciences and commercialization. The Union Cabinet, which approved the setting up of the institute under the 12th Five Year Plan in August 2012, will be mandated to: Undertake multi-disciplinary basic and strategic research with a view to future developing crops for traits such as increased yield, or increased tolerance to biotic and abiotic stress; Design and start academic programs to develop the highly trained manpower required for fundamental research in agricultural biotechnology, and award post-graduate doctoral and post-doctoral degrees; Provide its research output to breeders and developers in agricultural universities and other institutions, to develop the germplasm, vaccines etc. that would enhance productivity and reduce losses due to biotic and abiotic stress; Act as a mother institute that would provide both curricula and course material to India's agricultural universities and other institutions who are running or trying to establish successful agricultural biotechnology graduate and post graduate programs. Another initiative will be the National Institute of Biotic Stress Management for addressing plant protection issues. It will be established at Raipur, Chhattisgarh, a state in central India. Industry speaks Mr Sushil Karwa, managing director, Krishidhan Group of Companies, said, "In Union Budget 2013-14, the finance minister has announced allocation of Rs 500 crore to start a program in crop diversification and promote technological innovation along with Rs 3,415 crore for agri-research. These provisions are very encouraging for the core players of agriculture and the biotech sector as it would help us to focus more on research and development." He added that since the private sector is playing a leading role in biotech and agri sectors of the country, "we hope that government would channelize some funds in the private sector in the form of grants and soft loans to encourage it". "It would also motivate us to stress on developing innovative disease-resistant and drought-resistant seeds to deliver value added quality products that ensure higher yields at lower cost to farmers," he said. On suggestions from scientists, the finance minister said the budget has also proposed a pilot program on Nutri-Farms for introducing new crop varieties that are rich in micro-nutrients, such as iron-rich bajra, protein-rich maize and zinc-rich wheat. "I propose to provide a sum of up to $36.7 million (Rs 200 crore) to start the pilots," he said, during his budget speech, adding that he hopes to see a sufficient number of such pilots in the districts most affected by malnutrition. ]]> <![CDATA[â€œCoherence required in biotech industryâ€?]]> https://biospectrumindia.com/interviews/95/1447/coherence-required-in-biotech-industry.html https://biospectrumindia.com/interviews/95/1447/coherence-required-in-biotech-industry.html Fri, 01 Mar 2013 16:39:00 +0530 Q: Please tell us about the objectives behind organizing The International Conference on Mycorrhiza (ICOM) in India? What was the outcome? Dr Adholeya: The ICOM is an event organized under the auspicious of International Mycorrhiza Society (IMS) after every 3rd year. The objective of this event is to have researchers from the Globe participate in this specialized event and deliberating on progress for knowledge sharing. For the first time India was chosen as a venue after stiff competition because the progress in India in this area has been outstanding and currently leading in commercial production technology of mycorrhizal fungi and its successful application in Agriculture and Plant Production. Q:What are latest trends in Mycorrhiza technology? How is Indian bioscience industry benefitting from it? The mycorrhiza technology, ofcourse, is a unique and major achievement of India and TERI. However, progress in other areas such as: Molecular diversity and fundamental understanding of symbiosis are also progressed very well. Indian researchers had the opportunity to learn about those progresses besides many other research activities through this conference. Q: What is the market potential for this technology? The market potential of mycorrhiza has been growing very significantly and in last 10 years within India the market share of mycorrhiza out of the total biofertilizer production in the country is approx. 25%, which is a significant and rapid progress due to the technology development. The Global market is also growing rapidly and India is currently contributing to more than 30% market share of North American product needs. Q What has been the progress on the biodiesel research India? By when are the concrete outcomes expected to come? The biodiesel research has been progressing on the research front. However, policy and programme of the Government has not made major progress and did not provided impetus to this area at the desired level. However, research progress is significantly satisfying. Q: Which are the other technological areas that you are currently spearheading at TERI? Currently spearheading some of the nano nutrient and seed coating technology of mycorrhiza and other beneficial organisms in order to achieve next level progress in the area of agriculture by providing value added seeds to farmers for sustainable plant productivity by reducing chemicals in agriculture. Q: How do you look at the Indian Biotech industry in last one decade?Indian Biotech Industries are progressing. However much rapid progress is needed. There is a wide gap between investment in research and development and its reflection through intellectual property penetration into commercial biotech sector. This need various approaches to bring these in coherence at the earliest. ]]> <![CDATA[Biotech students connect with industry at SLS 2013]]> https://biospectrumindia.com/news/95/1311/biotech-students-connect-with-industry-at-sls-2013.html https://biospectrumindia.com/news/95/1311/biotech-students-connect-with-industry-at-sls-2013.html Fri, 01 Mar 2013 12:34:00 +0530 The BioSpectrum student lecture series organized at Shoolini University started with a thunderous applause from the hundreds of students who arrived from the various corners of Himachal Pradesh. The theme of the event held on February 27, 2013, was focused on exploring entrepreneurship and corporate opportunities for the aspiring students in the biotechnology sector. This initiative of BioSpectrum magazine, a publication of CyberMedia group of companies, has already been held in past at Bangalore, Mumbai and other major cities of India. In his opening speech, Prof P K Khosla, Vice Chancellor, Shoolini University stated, "We decided to align with BioSpectrun to bring the student community closer to industry. We thought of giving a chance to students to directly listen to industry and have an interaction with the industry leaders." Prof Khosla stated further, "We have been living in a cocoon without any significant interaction with the companies so far. But now we have to realize that this sector won't do better without any knowledge on industry." Narayanan Suresh, Group Editor, BioSpectrum and MIT's Technology Review gave an overview on Indian bioscience industry. "Most of the students are not aware about the happening in the industry. BioSpectrum presents a topical picture of the sector to all the stakeholders including the biotech student community. It feels great to be the part of this initiative and disseminate information to the students in this remote part of the country", said Mr Suresh. Mr Suresh further spoke on the relevance of the sector these days. "The drug discovery presents great opportunities in the research and the drugs are very vital for the diseases such as cancer. There are at least six distinct verticals within the sector and these include biopharma, bioagriculture, bioservices, bioindustrial, bioinformatics and biosupplier business. The major clusters are located in Bangalore, Hyderabad, Ahmedabad and NCR. The companies every year invest close to Rs 3,000 crore in various areas of research, marketing and manufacturing. It costs millions to get a new drug into the market. That means it is not an easy job but given its impact, the sector deserves utmost care and nurturing. The personalized medicine, healthcare for aging, contract research and manufacturing and biosimilars are the next big trends in the sector at present." Shoolini University in the previous year has been ranked at number two in the private university rankings by BioSpectrum biotech school survey that is held annually. In his address to the students, Dr Rajeev Soni, Associate Vice President, Biocon India, Bangalore and Founder Premas Biotech, Manesar, spoke on the various opportunities in biotechnology and the latest trends in biologics area. "I will speak to you today about what it takes to be an entrepreneur. It requires a BRICK. The 'B' in the brick stands for the belief and in real sense it is self belief. The 'RI' stand for the risk taking capabilities. However it has to be kept in mind that we cannot take the blind risk though it is necessary. 'C' stands for the change and that means the change in mindset. Change is one thing which is constant and with that we can change our and other's lives. 'K' stands for know thyself. One has to be aware about self needs and aspirations. I would say 'Be yourself'." Mr Sahil Kapoor, Director-Global Business Operations at Novo Informatics, New Delhi talked about the big world of informatics and its relevance in the bioscience industry. He cited many examples to tell students about various opportunities available in the bioinformatics sector."The importance of this bioinformatics in the computer aided drug discovery has been immense. The use of various softwares and databases to perform the molecular docking and further predict the nature of target molecules is highly relevant in present times", opined Mr Kapoor. Mr Pankaj Sharma, CEO, Director and Co Founder- LeadInvent, New Delhi, spoke about trials & tribulations of a bioscience entrepreneur. He listed out the must do's for the potential entrepreneurs among the students. Talking further about the entrepreneurship, Pankaj stated, "The passion about doing what your heart says and going ahead with their own idea despite the hardships is the strategy of an entrepreneur. The perception does matter a lot in deciding the course of action in the business of entrepreneurship. The feedback on what you plan to do and what have already initiated, is an important part of a long term strategy. Selling of an idea has to be instant and constant too In that context, there is disconnect between the students and the faculty that teaches them. This gap has to be bridged to achieve the greater results." While talking about the nuances of biosupplier business in India, Mr Manu Grover, Product Manager for Pharma Business, Waters India, Bangalore, spoke about the potential opportunities in this technology enabling industry. "There is growing demand for the biosimilars in India. 21 out of 100 top selling drugs are biosimiars. Biosupplier area has been expanding rapidly and the opportunity areas are mainly in instrumentation, manufacturing, distribution, diagnostics. The specific qualifications are required for the potential candidates to get absorbed in the biotech industry. The knowledge base is very important here. Along with the basic degree, you will require specific expertise in one area. The industry of course is highly competitive and students have to take their course and studies very seriously to stay relevant.", stated Mr Grover. Making students aware about the opportunities and career options, Mr Kapil Jhawar, Senior Clinical Project Manager, Quintiles India, Ahmedabad, mentioned, "In clinical research business, the understanding of whole process of how drug discovery happens and the knowledge of clinical trials process is very important. There are lot many opportunities in this area for the bright candidates." Mr Jhawar in his very interactive session with students also guided them about various stages of applying for specific jobs within the industry and getting recruited. He advised students to take the studies seriously as the completion in biotech industry is very high.The end of each session saw students participate in an interactive Q &A session. The vote of thanks was presented by Prof J M Julka, Professor, Shoolini University, who was highly appreciative of the participation and enthusiasm shown by the students. The event concluded with a closing address by Mr Suresh who insisted the students make the most of the wide array of opportunities that are available. The event concluded with a cultural programme that was enjoyed thoroughly by the audience. ]]> <![CDATA[Cipla announces plans to takeover SA based Medpro]]> https://biospectrumindia.com/news/95/3106/cipla-announces-plans-to-takeover-sa-based-medpro.html https://biospectrumindia.com/news/95/3106/cipla-announces-plans-to-takeover-sa-based-medpro.html Thu, 28 Feb 2013 11:23:00 +0530 Cipla has announced an offer to the shareholders of Cipla Medpro South Africa to acquire 100% of the ordinary share capital of Medpro for $1.13 per share. The offer will be implemented via a scheme of arrangement and is subject to regulatory and other approvals including approval by Medpro shareholders. The Board of Directors of Medpro have unanimously resolved to support and facilitate Cipla's Offer and recommended to Medpro shareholders that they vote in favour of all resolutions required to implement the Scheme. The proposed acquisition will be made either directly by Cipla or by a subsidiary nominated by it and will be funded largely through internal accruals and will consider other alternatives, if required. The total consideration payable by Cipla is approximately USD 512 million. Speaking of the Offer, Cipla CEO Mr. Subhanu Saxena said, "South Africa is an attractive emerging market with strong projected growth for generic drugs of approximately 14% per year for the next several years. This investment is aligned with Cipla's strategy to ascend the valueâ€?chain by managing a frontâ€?end sales force in a market outside India. Cipla and Medpro have enjoyed a longâ€?standing symbiotic relationship spanning two decades. The deal enables Cipla to strengthen Medpro's position in the South African pharmaceutical market, support the optimisation of Medpro's manufacturing capability and support Medpro's expansion into collaboratively identified African markets." Cipla Chairman, Dr. Yusuf Hamied added: "This investment is aimed at further strengthening our commitment to South Africa and the broader African continent. Patients and the healthcare landscape will benefit both from Cipla's 77+ years of experience across products, technologies, dosage forms and Cipla's ethos of striving hard to provide greater access to medicine." Cipla Medpro is one of South Africa's fastest growing pharmaceutical companies. The third largest pharmaceutical firm in SA, it is a leading provider of chronic medicines to the public and private sectors, with particular strength within, inter alia, the cardiovascular, antiretroviral (ARV), respiratory and neuropsychiatric categories. Medpro has 2 distribution centers in Cape Town, one in Durbanville and one in Atlas Gardens. ]]> <![CDATA[Mylan acquires Strides Arcolab's injectibles unit, Agila]]> https://biospectrumindia.com/news/95/6706/mylan-acquires-strides-arcolabs-injectibles-unit-agila.html https://biospectrumindia.com/news/95/6706/mylan-acquires-strides-arcolabs-injectibles-unit-agila.html Thu, 28 Feb 2013 11:05:48 +0530 Mylan has announced that it has signed a definitive agreement to acquire Agila Specialties, a developer, manufacturer and marketer of high-quality generic injectable products, from Strides Arcolab for $1.6 billion in cash. The acquisition of Agila will create a global injectables leader, significantly expanding and strengthening Mylan's global injectables platform and providing Mylan entry into new high-growth geographic markets. The acquisition is expected to be immediately accretive to Mylan's adjusted diluted earnings per share following closing. The transaction is expected to close in the fourth quarter of 2013, subject to regulatory approvals and certain closing conditions. Previously, news reports suggested that Pfizer was interested in the acquisition of Agila, as well. Mylan CEO Heather Bresch commented, "The addition of Agila to our existing injectables platform will immediately create a new, powerful global leader in this fast-growing, attractive market segment and accelerate our target of becoming a top-three global player in injectables. Agila's broad product portfolio and pipeline, which is very complementary to Mylan's, is the result of best-in-class research and development and an industry-leading track record of securing product approvals. Importantly, Agila will bring us one of the most state-of-the-art, high quality injectables manufacturing platforms in the industry." Agila, headquartered in Bangalore, India, will bring Mylan a broad product portfolio of more than 300 filings approved globally and marketed through a network covering 70 countries, including 61 abbreviated new drug applications (ANDAs) approved by the U.S. Food and Drug Administration (FDA). Agila has a global pipeline of approximately 350 filings pending approval, including 122 ANDAs pending FDA approval. Agila's research and development and regulatory track record are reflected in its industry-leading number of approvals and fast approval timeframes. The company currently produces products across nine high-quality manufacturing facilities in India, Brazil and Poland, eight of which have been approved by the FDA. Agila's manufacturing capabilities include vials, pre-filled syringes, ampoules, lyophilization, cytotoxics, and antibiotics. Agila's manufacturing base represents one of the largest steriles capacity in India and one of the largest lyophilization capacities in the world. In addition to its established presence in developed markets, Agila has a strong position in high-growth emerging markets, including Brazil. Mylan President Rajiv Malik added, "By combining Agila's strong injectables capabilities with Mylan's powerful global engine, we will catapult our injectables business to a new level. Agila will bring Mylan one of the deepest and broadest global injectables portfolios in the industry, and together we will have more than 700 marketed injectables products and a global pipeline of more than 350 injectables products pending approval. In addition, Agila will further expand Mylan's geographic footprint, providing us with entry into key growth markets, such as Brazil, and position us to leverage our global portfolio in these exciting markets, in line with our mission of providing the world's 7 billion people access to high quality medicine." Mylan CFO John Sheehan said, " We anticipate that the acquisition will immediately enhance our revenue and earnings growth upon closing, and nearly double our business from injectables in the first full year. Further, this transaction will significantly accelerate achievement of our $1 billion target for our institutional business. " Commenting on the transaction, Arun Kumar , executive vice chairman and group CEO of Strides Arcolab said, "Our investments in the Agila business, together with the operational excellence of our employees, have led to the creation a global, high-quality specialty injectables business with an industry-leading pipeline and best-in-class infrastructure. We believe Agila, its partners, customers and employees across all of its markets will benefit significantly from Mylan's global reach and strong position in the global generic and specialty pharmaceutical sector." Agila's capabilities complement Mylan's existing injectables platform of more than 500 products marketed globally, including 55 ANDAs, and its high quality sterile manufacturing facilities in Ireland and India. The global generic injectables market is expected to grow at a compound annual growth rate of 13%[1] from 2011-2017 driven by patent expiries, outpacing most other dosage forms. The combined Mylan/Agila portfolio will represent approximately 70% of regulated market demand for injectables and the combined R&D platform and manufacturing capabilities will position Mylan to be a significant participant in advanced new technologies to drive future growth. ]]> <![CDATA[8th Nutra India Summit to kick off from March 13 in Mumbai]]> https://biospectrumindia.com/news/95/4255/8th-nutra-india-summit-to-kick-off-from-march-13-in-mumbai.html https://biospectrumindia.com/news/95/4255/8th-nutra-india-summit-to-kick-off-from-march-13-in-mumbai.html Wed, 27 Feb 2013 11:41:07 +0530 The 8th Nutra India Summit, the country's biggest Nutraceutical, Functional Foods, Dietary Supplements and Ingredients Show will start off on March 13 in Mumbai and continue till March 16, 2013. The Summit is being organized by Council of Scientific & Industrial Research (CSIR), The International Society for Nutraceuticals, Naturals and Nutritionals (ISNNaN) and MM Activ Sci-Tech Communications. The event will witness four days of inspiring sessions with participation from 20 countries, over 60 exhibitors and 65 industry leaders speaking on the innovative trends in the nutraceutical industry. The summit brings together industry captains, scientists, policymakers, and academicians from the world of 'Nutraceuticals, Nutritionals and Naturals'. It will be the perfect venue to meet and collaborate. Nutra India Summit and NuFFooDS Expo will witness non-stop networking and connect with more than 300 organizations and more than 600 delegates. More than 5,000 business visitors are expected to visit in 4-day event. Some of the highlights of the event include the high-profile CEO Summit-bringing together the best minds in the industry to deliberate on globally relevant issues; the Nutra Awards- honoring the contribution of eminent personalities from this sector as well as recognizing new and innovative talent through poster awards; a special networking dinner for delegates and invitees and Nutra Partnering India for active networking. "At 8th Nutra India Summit, one can listen to and interact face to face with the policy makers and industry captains, connect with the international trade fraternity, enhance networking opportunities with prospective partners, benefit from buyers and sellers meet, interact with scientists, leaders from industry and universities, research institutions and technology-transfer organisations. At the NuFFooDS Expo companies could showcase their products and services, launch new products, explore new markets and reach out to more than 5000 business visitors." said Mr Jagdish Patankar, Organising Secretary, Nutra India Summit and Managing Director, MM Activ Sci-Tech Communications. Some of the interesting sessions to watch out for in the conference include product innovation in functional foods & dietary supplements, ingredients as well as regulation, innovation and claims and disease management through 3Ns. The event will provide global opportunities for Indian companies and also a chance to explore trends of Japanese functional food market, means & methods of nutraceutical exports to Europe, functional foods industry in Brazil and Chinese nutraceutical market. Herbalife is the event sponsor and Sami Direct Marketing , British Biologicals, OmniActive, Zeon Life Sciences, Kyowa Hakko, Enzo Nutraceuticals, Nexira India, TCI Company India, Heal Wellness are the other sponsors of the summit. Dr. V. Prakash, FRSC, Chairman, 8th Nutra India Summit; Distinguished Scientist of CSIR, India; Council Member, IUNS and IUFoST believes that in this era of social media, as more number of people are becoming aware of the significance of having a balanced, nutritious and healthy diet, the demand for nutraceuticals is growing multi-folds. As the country becomes a hub for the manufacturing of nutraceuticals and nutritionals, the responsibility of Nutra India Summit as a valid partner of the industry to influence and enhance nutraceuticals trade has become enormous. ]]> <![CDATA[Indegene:Enterprise mobility will be the next wave in pharma marketing]]> https://biospectrumindia.com/news/95/8153/indegeneenterprise-mobility-will-be-the-next-wave-in-pharma-marketing.html https://biospectrumindia.com/news/95/8153/indegeneenterprise-mobility-will-be-the-next-wave-in-pharma-marketing.html Tue, 26 Feb 2013 17:34:00 +0530 Indegene a scientific partner to global pharmaceutical and life sciences companies, recently partnered with Team Computers, a major enterprise IT solution provider, to host an exclusive executive briefing for senior pharma leaders on 'Driving Efficiency and Effectiveness in Pharma with Enterprise Mobility'. The event hosted by Team Computers and Indegene in Mumbai early this month was attended by over 40 senior sales, marketing, training, commercial, and business executives from leading global and Indian pharma companies. As pharmaceutical marketing continues to transform, consumers and stakeholders have changed the way they create and assimilate information. For instance, a recent study by Manhattan Research suggests that physicians interacting with med-reps using iPads are 35% more likely to request a sample; and 29% of physicians surveyed are more likely to prescribe the drug. Another study estimated that remote training could save a company approximately USD 1000 per year per rep, and with an enterprise solution, the saving could be significantly higher. Mr.Manish Gupta, CEO, Indegene Lifesystems said "Our new enterprise mobility framework allows clients to assess and deploy mobility solutions intelligently across multiple brands and teams. We expect this approach to be transformational in areas such as detailing, CLM, sales force training, and physician and patient engagement." One of the key takeaways from the event was the pervasiveness of mobility in pharma. Leveraging mobility solutions especially in the areas of SFE, detailing, and patient/physician education, given the intuitiveness of iPads and the customized delivery of interactive content, will positively transform the way companies engage with its stakeholders. Another point that emerged was the need for enterprise mobility. Implementing and maintaining hundreds of disparate apps and redundant information across multiple platforms, users, and brands is not a feasible long-term strategy. Instead, deploying mobility solutions that are designed with enterprise benefits, and can be intuitively adapted to several brands and teams is more important. ]]> <![CDATA[BASF's 'We create chemistry' tour showcases latest innovations]]> https://biospectrumindia.com/news/95/4561/basfs-we-create-chemistry-tour-showcases-latest-innovations.html https://biospectrumindia.com/news/95/4561/basfs-we-create-chemistry-tour-showcases-latest-innovations.html Tue, 26 Feb 2013 12:16:00 +0530 Recently, BASF had organized a "We create chemistry" world tour, to highlight its innovative ideas to solve global challenges in Mumbai. The interactive event, billed to be the "marketplace of innovations" in BASF was earlier kicked off in Mannheim, Germany, in January 2012 and will continue until mid-2013.It is designed to help the company's stakeholders experience some of the company's leading innovations for a sustainable future. The interactive exhibition features 20 world-class BASF innovations, ranging from organic solar cells to electro-mobility solutions to modern insulation materials and sustainable concrete technologies and advances in crop technologies. "Through the Marketplace of Innovations, BASF is showcasing solutions from the world of chemistry for the challenges of a growing world population. The exposition's examples of BASF's innovations in sustainability tangibly demonstrate how economic success, social responsibility and protecting the environment are interconnected as key elements of our strategy," remarked Mr. Prasad Chandran, Chairman, BASF Companies in India & Head South Asia. BASF's portfolio in India ranges from chemicals, plastics, performance products, functional solutions to agricultural solutions. In 2011, BASF in India registered sales of â‚¬1.2 billion. On the ecological front, they have a robust Environment, Health and Safety (EHS) policy in line with global standards. BASF in India has 2070 employees, nine production sites and two R&D centers that work closely with BASF's Global Technology platform. As one of the world's leading chemical company, BASF is committed to introduce chemical innovations that enable its customers develop differentiated and innovative products, processes and technologies, in order to meet the current and future demands of the society. The "We create chemistry" world tour in this perspective offers stakeholders a panoramic view of the latest and most exciting innovations from BASF. Prior to Mumbai, the "marketplace of innovations" has made numerous stops - Shanghai in China, as well as Detroit, Florham Park, Charlotte, Houston, Mexico City, Toronto and Sao Paulo in North and South America. In Asia, after Mumbai, the tour will travel to Tokyo in February and Seoul in May 2013. "At the tour, we prove with proof-points that innovation is the key to solving global challenges", concluded Mr. Chandran. ]]> <![CDATA[IMTECH's Streptokinase contributions worth Rs.20,000 crore]]> https://biospectrumindia.com/news/95/5951/imtechs-streptokinase-contributions-worth-rs-20000-crore.html https://biospectrumindia.com/news/95/5951/imtechs-streptokinase-contributions-worth-rs-20000-crore.html Tue, 26 Feb 2013 11:58:00 +0530 A recent survey report by CSIR has stated that the societal contributions by IMTECH's research on developing indigenous methods of Streptokinase production are valued at Rs.20,000 crore. Dr. Girish Sahni, Direcor, IMTECH, who has headed the Streptokinase project says, "In a survey conducted by CSIR, it was found that the different brands that have emerged from the technologies that were licensed from IMTECH, constitue about 45-50% of the total market share for Streptokinase in India." Industry estimates peg the Streptokinase market to be in the whereabouts of $20million. Dr.Sahni says that the Streptokinase market is expanding, and even though the number of doses are increasing,the costs are decreasing, The Streptokinase story is said to be one of CSIR's and Indian research's definitive stories for successful applied technology transfer from academia to the industry that has had a direct impact on human life.The continuing project has involving 10 years of hard work by over 50 scientists working at IMTECH. Streptokinase was available in Western countries as a treatment modality for mycordial infarctions since the 1980s but had to be imported in India for almost two decades. The first generation of Streptokinase developed at IMTECH, the natural streptokinase was transferred to Zydus Cadila and successfully produced in 2001. This product is still being sold, at one third the price of the imported version. IMTECH then outlicensed the know-how for the production of recombinant streptokinase to Shasun Chemicals and Drugs, which launched it in 2009. Currently, the third generation streptokinase,a clot specific one has been developed and outlicensed to Nostrum Pharmaceuticals. Earlier the deal was pegged at Rs. 5.5 million, but once IMTECH started developing a 4th generation streptokinase simultaneously, the deal was extended to Rs. 150 million in the form of cumulative milestone based payment for both the types of Streptokinase .The Phase I trials for the third generation streptokinase have now completed and show extremely positive results when it comes to safety, according to Dr.Sahni. This version does not destroy blood factors such as fibrinogen, like the previous versions, which lead to bleeding. IMTECH is also currently developing the 4th generation which will avoid reclotting, which occurs in 20-30% of patients. They have filed for patents for the same as well, however this research is in extremely early stages. Nostrum can further outlicense it to different companies as per the markets, once it comes to the market. Dr. Sahni adds, that the clinical trials for the third generation streptokinase were cleared in a record time of 6 months by the DCGI. He believes that, the fact that this was a joint venture with a renowned research institute, and not just a private company worked in their favour. Dr.Sahni adds, " We have directly saved lives with the technology, as it is not just the elite who have heart attacks. I think the inspiration for pursuing this research germinated when a doctor at a hospital in Chandigarh told me that they had to turn away people for treatment, since it would be too costly. That inspired me the most. No reward is equivalent to the knowledge that our research has helped to save lives" Widely considered to be a pioneer in translational research in India, Dr. Sahni signs off by saying, "Indian researchers do have the capability to do so much more, they just have to rearrange their work to more application oriented research such that it can have tangible results. I believed it is not a challenge of capabilities , but of the mindset." ]]> <![CDATA[Venus seals marketing deal with Adock ]]> https://biospectrumindia.com/news/95/3183/venus-seals-marketing-deal-with-adock-.html https://biospectrumindia.com/news/95/3183/venus-seals-marketing-deal-with-adock-.html Mon, 25 Feb 2013 16:12:00 +0530 The exclusive marketing rights agreement between Venus Remedies and South Africa's second largest pharmaceutical company, Adcock, is for the novel novel antibiotic adjuvant entity (AAE), Potentox. The product developed at Venus Medicine Research Centre(VMRC), has been found effective against penicillin and multidrug set of antibiotics resistance. The product would be supplied out of Venus's state-of-art EU GMP approved manufacturing facility at Baddi. The company has already been marketing it successfully in India and few of the emerging markets around the globe. The product is growing with a CAGR of 25% since past 3 years. The company is under discussion for the strategic tie-ups on Potentox with other international pharma companies in regulated markets as well. As per Dr (Mrs) Manu Chaudhary, director- research - VMRC, JMD Venus Remedies, "Infections caused by resistant microorganisms often fail to respond to conventional treatment, resulting in prolonged illness and greater risk of death. Getting Potentox to South African market at such point in time can prove to be all the more significant for society at large as the drug works synergistically on multi-drug resistant bacteria that not only halts the development of bacterial resistance but also its spread." South Africa has had one of the highest reported rates of pneumococcal penicillin resistance in the world, as high as 76%. Almost 25% of S. pneumoniae isolates from South Africa are multi drug resistant.The overall systemic antibacterial market of South Africa is approximately USD 275 million growing at CAGR 10.5%, out of which this product is designed to address a segment as big as 25% and company projects to gain a market share of 15% of this segment within 3 years of launch making it over USD 10 million product in South Africa itself. Commenting on the deal, Mr Pawan Chaudhary, CMD Venus Remedies said, "We are pleased to join hands with Adcock and are confident that the deal shall take our research product to its meaningful stage in South Africa. Adcock will have exclusive marketing rights of the product in South Africa over the period of 15 year. The product will remain under patent protection till 2025 in African territory and is expected to be launched by mid of 2015 after getting due regulatory approvals." Potentox is a research based antibiotic product of the company protected by patent in USA and in number of other countries across the globe including India, Canada, Australia, New Zealand, South Korea, South Africa and Ukraine. It is an antibiotic adjuvant entity (AAE); a new drug product effective in case of hospital Acquired Pneumoniae and Febrile Neutropenia infections, including Penicillin and Multidrug resistant case proved through clinical studies on >500 patients, which has also indicated approximately 20-30% reduction in the cost of therapy as compared to conventional therapies being used. ]]> <![CDATA[Bangalore hosts workshop on â€œGenomics of crop Improvementâ€? ]]> https://biospectrumindia.com/news/95/7611/bangalore-hosts-workshop-on-genomics-of-crop-improvement-.html https://biospectrumindia.com/news/95/7611/bangalore-hosts-workshop-on-genomics-of-crop-improvement-.html Mon, 25 Feb 2013 16:04:00 +0530 A three day workshop on "Genomics of crop Improvement" was held at Institute for Bioinformatics and Applied Biotechnology (IBAB), established by Karnataka government with the Department of Biotechnology (DBT), Government of India at Bangalore. Dr K. VijayaRaghavan, Secretary, Department of Biotechnology, Government of India, inaugurated the workshop, on February 18, which was presided by Dr P. M. Murali, President, Association of Biotechnology Led Enterprises (ABLE) and MD & CEO, Evolva Biotech. Prof Ronald L. Phillips, Regents Professor Emeritus, University of Minnesota, USA made a key note address on "Genetic diversity and human capacity building as fundamental for crop improvement." Scientists and experts spoke and discussed on many topics such as Linkage/Association Mapping (Statistical Genetics), Genotyping & Bioinformatics, Genomic/Genetic Resources, Comparative Genomics, Marker-Assisted Selection, Breeding for Stress, Nutrient Efficiency and Biofortification besides other issues as well. More than 100 scientists and several students especially from Indian Council of Agricultural Research (ICAR), Council of Scientific and Industrial Research (CSIR), and the Universities actively participated, besides few foreign delegates from Brazil, South Korea, and the USA. Sharing his thoughts Prof Padmanaban,INSA Senior Scientist, Senior Science and Innovation Advisor, Biotechnology Industry Research Assistance Council (BIRAC), Department of Biotechnology, Government of India made it clear that a combination of modern biotechnology tools such as MAS and GM technology are complementary, and are essential for successful development of new cultivars capable of higher productivity and adaptation with fewer inputs. However, wherever there is no or inadequate variation to use for desired traits (such as resistance to stalk borers in cereals) one need to resort to incorporate alien genomes (such as from universally found soil bacterium, Bacillus yielding Bt. gene that is also used by organic farmers for decades without nay safety issue) as suggested by Swaminathan panel while recommending creation of Biotechnology Regulatory Authority of India [ BRAI]. Experts at the workshop pointed out that the same DNA science that has revolutionized modern medicine has now been successfully applied to improve crops and develop new varieties with high yield, enhanced resistances to pests, adaptability to adverse environment, and superior product quality. Decoding of genetic information stored in all genes of an organism - commonly called genomics- has allowed discovery of novel genes responsible for specific valuable traits useful to increase crop improvement. Important take-away from the conference 1. Plant Genomic research in India is active and fast catching up with the international benchmarks. In the past, India has collaborated for sequencing of genomes of rice and tomato, and now for wheat; however, within last few months itself, solely with indigenous effort, draft genome sequences of neem and Amaranthus have been assembled by IBAB,Bangalore. 2.Genomic tools have been developed in various laboratories and successfully applied to breed new crop varieties such as that of rice combining resistances to blast, rust and gall midge; with conventional visual selection alone, improvement and stacking (pyramiding) for such complex traits could not have been possible. Many more products including wheat, rice, sorghum, chickpea, soybean, pigeonpea and vegetable crops varieties bred with DNA markers (by a process called MAS, or marker-assisted selection) are in the pipeline. Besides government laboratories, all major seed companies are routinely using this technology in breeding. 3. Many new markers and genes are discovered, and great deal of synteny (similarity in genome composition) and gene order (co-linearity) in crops are explored; many desirable genes appear in separate allelic forms in different species with varying effects on crop yields, and these can be used across reproductive barriers by methods such as genetic engineering wherever sexual barriers exist. Such products of genetic engineering are not inherently unsafe; note as many as 2000 gens are common even between human and plant genomes. 4.Many Indian and multinational private sector companies also took active part in the workshop by making oral and poster presentations; private sector invests significant amount of their revenues for development of such modern tools and their use in crop improvement. Indian farmers will soon able to reap the enhanced benefits of these efforts that are bound to increase their profitability and greater assurance of food safety and better nutrition by all including the urban consumers who of late have been demanding such benefits without undue cost increases. 5.The group exhorted that the scientific community should effectively engage the public for fostering greater uptake of novel technologies for evolving better crop varieties, and to stand up to any wrong or mischievous propaganda to discourage large-scale cultivation of crops bred with the aid of combination of biotechnology tools. ]]> <![CDATA[BMJ Group announces further investment in India]]> https://biospectrumindia.com/news/95/7470/bmj-group-announces-further-investment-in-india.html https://biospectrumindia.com/news/95/7470/bmj-group-announces-further-investment-in-india.html Mon, 25 Feb 2013 14:00:59 +0530 BMJ Group, one of the world's leading healthcare knowledge providers, this week announced further investment in its India operations. The company will recruit a Managing Director to head up its growing workforce in the country. And in the first quarter of 2014 it will be launching the BMJ Awards India, to recognise the best individuals and teams practising in Indian healthcare. BMJ Awards has been long-established in BMJ Group's home market, the UK, and has even attracted winning entries directly from India in recent years. That's why the company believes it's time for India to have its own awards programme to showcase excellence in healthcare. "We hope to make it the 'Oscars' of Indian medicine", says Tim Brooks, BMJ Group CEO. He adds: 'We are excited to take our investment in India to the next level. The BMJ already enjoys high readership and recognition among healthcare professionals in India. Our growing presence in the subcontinent will be strengthened by the appointment of an MD, based at our head office in Delhi." The BMJ is one of the most respected general medical journals in the world with a weekly print circulation of 122,000 and 1.2 million monthly visitors to bmj.com.The Group also has a strong reputation for providing medical education through digital media. The BMJ was the first general medical journal to launch an iPad app, and is now also available as a tablet app. It's portfolio of specialist journals is also available through mobile optimised websites. BMJ's Best Practice app enables healthcare professionals to make better decisions for their patients, while BMJ Learning and BMJ Quality offer a range of online tools to help doctors improve their knowledge and skills. The Group also works with public sector and governments around the world, including the UK NHS and the Ministry of Health in Brazil, helping to support quality improvement and better outcomes for patients. "We look forward to working closely with Indian states and institutions to bring training and knowledge that aligns with their needs," says Tim Brooks. "Our ambition is to deliver evidence-based content into the daily workflow of health professionals in formats that recognise the demands of clinical life and help India become a world leader in medical training and research." These steps follow the launch earlier this month of bmj.com/India, a bespoke version of its global general medical journal, The BMJ. The site features medical news, comment, research and educational content produced by and relevant for Indian practitioners, and is edited by Mumbai-based Dr Anita Jain. The launch of BMJ.com/India comes with a strategy to triple visitor numbers from India in the next 3 years ]]> <![CDATA[Every fifth generic drug is manufactured in India]]> https://biospectrumindia.com/news/95/3519/every-fifth-generic-drug-is-manufactured-in-india.html https://biospectrumindia.com/news/95/3519/every-fifth-generic-drug-is-manufactured-in-india.html Mon, 25 Feb 2013 08:51:00 +0530 The Department of Pharmaceuticals (DoP) under the ministry of pharmaceuticals have informed that as per the report of the working group on drugs and pharmaceuticals for the 12th Five Year Plan, the Indian pharmaceutical industry has grown from Rs 71,000 crore in 2007 to over Rs 100,000 crore in 2009-10 comprising Rs 62,055 crore of domestic market and exports of over Rs 42,154 crore. According to the report, Indian pharma industry is ranked 3rd globally in volume and 14th in value, supplying around 10 percent of total global production. This also amounts to around 20 percent of total volume of global generics. Thus, every 5th tablet, capsule and injectable in generic drugs consumed anywhere in the world is manufactured in India. Speaking on the topic, the union minister for health and family welfare, Mr Ghulam Nabi Azad had in the parliament that, "Instructions have been issued from time to time to all central government hospitals and CGHS dispensaries to prescribe generic medicines to the maximum extent possible. The state governments have also been asked to instruct their doctors to prescribe generic medicines." The export data of the pharmaceutical products as provided by the Department of Commerce for the last three years revealed that there has been a substantial increase in exports. While in the year 2009-10, it was Rs 24,570.26 crore, the exports increased to Rs 25,130.42 crore in 2010-11. Again in 2011-12, the exports registered an increase of Rs 40,218.15 crore. ]]> <![CDATA[Health ministry to tighten drug regulations ]]> https://biospectrumindia.com/news/95/3095/health-ministry-to-tighten-drug-regulations-.html https://biospectrumindia.com/news/95/3095/health-ministry-to-tighten-drug-regulations-.html Mon, 25 Feb 2013 07:13:00 +0530 The union health minister, Mr Ghulam Nabi Azad recently revealed that a new scheme has been prepared by the central government for providing assistance for strengthening of state drug control departments during the 12th Five Year Plan. The minister further stated that, the Drugs and Cosmetics Act, 1940 has been amended by Drugs and Cosmetics (Amendment) Act, 2008 for making penal provisions under the Act more stringent. The Drugs and Cosmetics (Amendment) Act, 2008 also enabled establishment of special designated courts for trial of offences related to spurious and adulterated drugs. So far 14 states/UTs have already set up such courts. Mr Azad also stated that whistle blower scheme has been initiated to encourage vigilant public participation in the detection of movement of spurious drugs in the country. Under this scheme the informers would be suitably rewarded for providing concrete information in respect of movement of spurious drugs to the regulatory authorities. "Strengthening and up-gradation of infrastructure and facilities of Central Drugs Standard Control Organization (CDSCO) is an continuous and on-going process depending upon increase in responsibilities and consequent workload. Since 2008, 216 additional posts in the CDSCO have been sanctioned," the health minster mentioned while speaking in the parliament on February 22, 2013. Mr Azad also reiterated that only 0.046 percent of the drugs were found spurious in a survey by the drug controllers' office. This nationwide survey to assess the extent of spurious drugs in the country was conducted in the year 2009 by the health ministry. Survey was only related to spurious drugs which are manufactured clandestinely. The survey did not have reference to assess the losses occurred to the original manufactures on account of this malpractice. About 24,136 samples of 62 brands of drugs belonging to nine therapeutic categories of 30 manufacturers from over 100 different pharmacy outlets in different regions of the country were drawn from different strata in various regions in the country. Further, on the basis of the information collected by the state drug control departments, the number of samples of drugs declared as not-of standard quality has been found to be around 4.75 percent only. "The manufacture of spurious drugs being a clandestine activity can be curbed only through continuous surveillance and surprise inspections by the state drug control departments," said Mr Azad. ]]> <![CDATA[Bioseed Research bags ISBA award]]> https://biospectrumindia.com/news/95/4859/bioseed-research-bags-isba-award.html https://biospectrumindia.com/news/95/4859/bioseed-research-bags-isba-award.html Fri, 22 Feb 2013 18:01:08 +0530 Bioseed Research India (BRI), the hybrid seed business of DCM Shriram Consolidated (DSCL), has been awarded the Indian STEPs and Business Incubators Association (ISBA) 2013 "Performance Award" in recognition of BRI's successful partnership with the Agriculture Business Incubator (ABI) at International Crops Research Institute for the Semi-Arid Tropics (ICRISAT). Bioseed Research India was conferred the award at the ISBA Awards ceremony held on 8th February 2013. The ISBA 2013 Performance Award was presented to BRI in appreciation of their outstanding performance results achieved through employing innovative techniques to accelerate Bt cotton hybrid development. On receiving the award, Dr Paresh Verma, Research Director, Bioseed Research India Ltd said, "It is a privilege to receive this award as an acknowledgement of our innovative research program. The supportive environment provided by the ABI at ICRISAT helped us to focus on enhancing our research and production capabilities to significantly reduce the time taken for products to reach the market. This recognition will encourage us to achieve greater successes in the future." Indian Science and Technology Entrepreneurs Parks and Business Incubators Association (ISBA), is a dynamic value network of incubators of India, engaged in promoting innovation and entrepreneurship in the country. With active membership of incubators and affiliates, ISBA constantly strives to leverage incubation performance in India and endeavors to represent and interface, the Indian Incubation, with the global incubation community, for mutual growth. With the greater agenda for continually expanding the frontiers of Incubation, Innovation and Entrepreneurship, to bring in new benefits to the society, ISBA regularly undertakes various dissemination initiatives, including the present conference, to fruition. ]]> <![CDATA[ATRO calls for collective cancer research in India]]> https://biospectrumindia.com/news/95/2965/atro-calls-for-collective-cancer-research-in-india.html https://biospectrumindia.com/news/95/2965/atro-calls-for-collective-cancer-research-in-india.html Fri, 22 Feb 2013 16:45:08 +0530 With Bangalore having the highest incidence of cancer cases ( 113.4 - males and 139.1 - females) among key cities in India, there has been an urgent call to action to debate existing cancer care, treatments and research based medicine. The next other cities having the highest incidence of cancer cases in India include New Delhi (124.3 - males and 121.2 - females) followed by Mumbai (99.1 - males and 110.4 - females), according to the latest Population Based Cancer Registry, cancer incidence for every 1, 00,000 males and females in key cities in India. "India as a country has immense potential to be one of the leaders in oncology research with its burgeoning cancer population and comprehensive cancer care centers," said Dr. B.S.Ajaikumar, President, Association for Transitional Research in Oncology (ATRO) at the Afro-Asian Conference of Transitional Research in Oncology (ACTRO) that commenced in Bangalore on February 22. The three day conference brought together oncologists from Asia and Africa, to discuss the need for personalized cancer care and a repository of cancer based research in the country. The conference began with research topics focused on personalized medicine, organ and functional preservation in breast cancer, hematology and stem cell transplant and cardio thoracic oncology. Dr. B.S.Ajaikumar, further said, " The theme of this conference is "From Bedside to Benchmark" with a focus on superior cancer care for patients through futuristic technology to improve their quality of life. Due to dearth of research in India, we have been depending on the western population data and guidelines, to manage the problem. The ACTRO 2013 conference will act as a platform for oncologists to analyze our own cancer care treatment outcomes, through efficient documentation and data management." Dr. Prahlad Ram, Medical Oncologist, MD Anderson Cancer Center, USA, said, "One of the emerging challenges in oncology is the utilization of patient-specific genomic information in order to develop personalized and targeted therapeutic options based on molecular aberrations in the tumour. A second challenge facing cancer medicine is the identification of pharmacological options to overcome resistance and the repurposing of currently approved drugs for cancer therapy." Dr. Samuel JK Abraham, Surgical Oncologist, Yamanashi University-faculty of Medicine, Japan, said, "In the human immune surveillance system, a combination of adaptive and innate pathways work together to tackle cancer. When functioning optimally, they destroy any aberrant cell which might evolve into a cancer. The dysfunction of the immune system by itself or a relative dysfunction against an overwhelmingly strong cancer causative factor culminates in cancer development. One of the therapy aims is to empower the autologous immune cells to treat an already diagnosed cancer and also to prevent a cancer development as well its recurrence." There are about 30 million cancer survivors in the world today, which is expected to rise to 70 million by the end of the year 2050. ACTRO aims to bring together oncologists to discuss preventive care and improved treatment, to advance the quality of life of cancer patients and survivors across the country. ]]> <![CDATA[Medical Fair India to attract over 300 exhibitors ]]> https://biospectrumindia.com/news/95/1210/medical-fair-india-to-attract-over-300-exhibitors-.html https://biospectrumindia.com/news/95/1210/medical-fair-india-to-attract-over-300-exhibitors-.html Fri, 22 Feb 2013 15:00:00 +0530 A three day Medical Fair India 2013, formerly known as HOSPIMedica India, an international trade exhibition and conference on Diagnostics, Medical Equipment and Technology jointly organized by Messe DÃ¼sseldorf, Germany (organizer of "MEDICA" world's largest medical trade show) and its Indian subsidiary Messe DÃ¼sseldorf India Pvt. Ltd, will be held at Pragati Maidan, New Delhi India from March 8, 2013. The release noted that over 300 manufacturers of medical equipment and technology from over 10 countries including France, Belgium, USA, China, SE Asia, Germany and India shall showcase their modern and most innovative range at the Medical sector's biggest exhibition. On display will be world-class Hospital Supplies, Surgical Items, Medical Disposables, Rehabilitation Aids, Diagnostics, Hospital Furniture, Radiology and Imaging Equipment, Physiotherapy Equipment, Critical care/Emergency Equipment, Disinfection & Waste Management Systems, Medical Software and Medical Publications. Medical Fair India is going from strength to strength as the number of exhibitors in the current edition is likely to be more than 300 as against last event. The fair had attracted more than 6000 visitors last year and a further rise in the number of visitors is anticipated for 2013 too. Medical Fair, which alternates annually between Mumbai and Delhi, is the ideal platform to meet the "Who's Who" of the sector, to discuss and seal new deals. About 60% of the exhibitors come from countries such as France, Belgium, Malaysia, Taiwan, Korea, the USA and Germany. This is also the first time that the organisers look forward to welcoming exhibitors from Japan and Finland. The Indian healthcare sector is expected to become a US$ 280 billion industry by 2020 with spending on health estimated to grow 14 per cent annually, according to a report by an industry body. At present the sector is estimated to be around US$ 40 billion and will grow to US$ 78.6 billion by end-2012, Better standard of living, improved education and increasing incidence of lifestyle diseases is triggering a higher demand for modern, quicker treatment methods and newer forms of therapy/diagnosis. The fair is supported by Indian associations such as ADMI (Association of Diagnostic Manufacturers of India), MSAHITA (Medical Surgical and Healthcare Industry Trade Association) and at the international level, by institutions such as MREPC (Malaysian Rubber Export Promotion Council), CCCMHPIE (China Chamber of Commerce for Import & Export of Medicines & Health Products), KMDICA (Korea Medical Devices Industrial Cooperation Association), Ubi France, SAMD (Shenzhen Association of Medical Devices), Spectaris, GHE (German Health Care Export Group) and the ZVEI (Zentralverband Elektrotechnik und Elektroindustrie e.V.). ]]> <![CDATA[Is time right to review bt cotton regulations?]]> https://biospectrumindia.com/news/95/1272/is-time-right-to-review-bt-cotton-regulations.html https://biospectrumindia.com/news/95/1272/is-time-right-to-review-bt-cotton-regulations.html Fri, 22 Feb 2013 11:30:00 +0530 As per the latest report of International Service for the Acquisition of Agri-biotech Applications (ISAAA), India grew a record 10.8 million hectares of Bt cotton with an adoption rate of 93% and enhanced farm income from it by US$12.6 billion in the period 2002 to 2011 and US$3.2 billion in 2011 alone. Commenting on the report, Mr Bhagirath Choudhury, national coordinator, International Service for the Acquisition of Agri-biotech Applications (ISAAA), told BioSpectrum, "The Bt cotton has been a very successful story in Indian agricultural history. The adoption rate of theis crop has been very rapid and it enjoys great popularity amiong cotton growers. It is a matter of time that it will take over the remaining part. Most importantly it is the farmers who despite lot of negativism, has still chosen to grow it and reap the benefits economically." Mr Choudhury also feels that the policy makers have to fell the pulse of the farmers and allow them a choice without mandatory conditions for cultivation. He opined further, "It is astonishing to see that the farmers have to purchase the non bt cotton and cultivate them along with bt cotton under mandatory rules that comes with growing of the crop. It puts a load on the poor farmers who must have a choice to grow their crop of interest. Also they need to be allowed to retain the seeds." "However, if the authorities still feel that it is neccessary for farmers to do so, they could be asked to mix both seeds as per their will and go ahead with the cultivation. It is ridiculous to say that technology will cause harm the biodiversity. Infact the availability of such alternatives will help in enhancing the concept and extend its horizons," he added. India was among five lead biotech developing countries that includes China, Brazil, Argentina and South Africa to collectively grow 46% of global biotech crops, and have 40% of world population. To-date, biotech cotton in developing countries such as China, India, Pakistan, Myanmar, Bolivia, Burkina Faso and South Africa have already made a significant contribution to the income of >15 million small resource-poor farmers in 2012; this can be enhanced significantly in the remaining 3 years of the second decade of commercialization, 2013 to 2015 principally with biotech cotton and maize. "Unprecedented high adoption rates are testimony to overwhelming trust and confidence in biotech crops by millions of farmers worldwide," said Dr James, who is also the author of ISAAA's annual Global Status of Commercialized Biotech/GM Crops. He added that "Farmers are masters of risk aversion. As soon as biotech crops are commercialized, their adoption is rapid, leading to near or complete optimization - the simple reason for the success of biotech crops in the U.S., and in another 28 countries around the world, is that they generate significant and multiple benefits by reducing yield loss from insect pests, weeds and diseases, and also result in substantial savings of pesticides." Dr James added that "The latest ISAAA data for 2011 shows Bt cotton in India at 88%, and biotech soybean in Brazil at 83%. Given that products in mature markets are already plateauing at close to optimal rates, incremental annual growth in adoption will be more modest and will be boosted as: 1.) additional hectares are planted, as was the case with total maize plantings in the US in 2012 (up 5%); 2.) new traits or new biotech crops are approved; or 3.) new countries adopt biotech crops." ]]> <![CDATA[Bessemer Venture Partners promotes Subramanya S.V. as MD ]]> https://biospectrumindia.com/news/95/7856/bessemer-venture-partners-promotes-subramanya-s-v-as-md-.html https://biospectrumindia.com/news/95/7856/bessemer-venture-partners-promotes-subramanya-s-v-as-md-.html Thu, 21 Feb 2013 18:39:05 +0530 Bessemer Venture Partners, a top venture capital firm backing great entrepreneurs, announced the promotion of Mr Subramanya S.V. (Subu) to Managing Director. This formalizes the leadership role he has played in the firm's Bangalore office and recognizes his contribution to BVP since he joined the firm in 2007. "BVP's global strategy has created growth for the firm and for the innovative companies we back around the world. Key to cracking high potential markets, such as India, is the presence of strong investors on the ground," said Ed Colloton, a partner in the Menlo Park, California office where he is chairman of the firm's investment and management committees and leads the operations of the firm. "Subu's leadership skills, knowledge of the business landscape in India, and his strong investments in consumer and technology start ups will position him to grow BVP's business in coming years." Subramanya focuses on investments in technology and consumer businesses. He was closely involved with the firm's investments in IL&FS Transportation Networks, Palogix Infrastructure, Tulip Telecom, Anantraj Industries and Riddhi Siddhi Gluco Biols among others. Prior to joining BVP, Subu worked with Avendus Capital, an Indian investment bank, where he advised companies on private equity transactions and mergers and acquisitions. Previously, he was a consultant with KPMG and started his career as a programmer with Wipro Technologies. Subu holds a bachelor's degree in Computer Science and Engineering from Mysore University and an MBA from the Indian Institute of Management Ahmedabad. With offices in Mumbai and Bangalore, BVP has 10 investors focused on growth and innovation opportunities in India. Since 2004, Bessemer has invested in more than 24 companies in India. With $4.0 billion under active management, BVP is a global venture capital firm with offices in Silicon Valley, Cambridge, Mass., New York, Mumbai, Bangalore and Herzliya, Israel. BVP that delivers a broad platform in venture capital spanning industries, geographies, and stages of company growth has invested in two firms - NephroPlus and MediAssist in India in 2011. NephroPlus is a well established chain of kidney care clinics that is shaping quality kidney care all over India. MediAssist is a Third Party Administrator of health insurance policies. ]]> <![CDATA[Enforcement Directorate attaches 96 acres of land from Aurobindo Pharma]]> https://biospectrumindia.com/news/95/4040/enforcement-directorate-attaches-96-acres-of-land-from-aurobindo-pharma.html https://biospectrumindia.com/news/95/4040/enforcement-directorate-attaches-96-acres-of-land-from-aurobindo-pharma.html Thu, 21 Feb 2013 18:01:06 +0530 The Directorate of Enforcement, New Delhi, has attached 96 acres of land belonging to Aurobindo Pharma in a case where charge sheet was filed by CBI in the Court of Principal Special Judge for CBI Cases, Hyderabad. In a statement to Bombay Stock Exchange on February 21, Aurobindo Pharma noted that the barren vacant land situated at Kota Bhogapuram Village, Vizianagaram District of Andhra Pradesh was belonging to APL Research Centre, a 100% subsidiary having no operations and a fixed deposit of Rs 3 crore of the company. These are equivalent to the value (Rs. 12.90 crore) of the alleged benefits mentioned in the charge sheet. The release from the company further noted that it has contested the matter before the Adjudicating Authority under the Prevention of Money Laundering Act, 2002. The Adjudicating Authority vide Order dated February 15, 2013 has confirmed the Attachment. The company has full regards for Law and the legal process and that it is in the process of appealing the decision before the Appellate Tribunal. The Company maintains that there has been no wrong doing on its part and hope that the truth will prevail. The share price of Aurobindo Pharma has dropped by about Rs 10 during the day from day's opening of Rs 185. This attachment order does not have any material implications on the current and future business operations of the company, the release noted. It may be recalled that in March last year, Aurobindo Pharma, Managing Director, Mr K Nityananda Reddy has been named in the charge sheet filed by CBI against YS Jagan Mohan Reddy and 12 others in an alleged disproportionate assets case. ]]> <![CDATA[LifeCell raises Rs. 35 crore from Helion Venture Partners]]> https://biospectrumindia.com/news/95/7573/lifecell-raises-rs-35-crore-from-helion-venture-partners.html https://biospectrumindia.com/news/95/7573/lifecell-raises-rs-35-crore-from-helion-venture-partners.html Thu, 21 Feb 2013 15:50:00 +0530 LifeCell International one of India's largest and most accredited stem cell banks, announced it securing an investment from Helion Venture Partners, an India focused venture fund. The Rs.35 crore funding will support its plans of increasing market penetration of stem cell banking in India whilst also enabling the development of novel cell based therapies. Started in 2004, LifeCell is a market leader in preservation of stem cells from various human tissues such as umbilical cord and menstrual blood, having serviced over 65,000 clients across 110 locations in India and abroad. Its central processing and storage facility is in Chennai, with a recently opened back-up unit at Gurgaon. It also is a provider of other key services such as bedside stem cell processing and newborn screening. LifeCell has grown over 50% annually over the last 3-years, and this year its annual revenues are projected to exceed Rs 100 Crores. With this investment of Rs 35 Crores, Helion Venture Partners becomes the first venture capital firm to invest in a stem cell banking company in India. Commenting on the announcement, Mr. Mayur Abhaya, CEO & Managing Director of LifeCell said "As pioneers in this space we have the responsibility to make best-in-class stem cell banking and therapies accessible to more people, and believe that this investment will take LifeCell a step closer to realizing that vision. We're delighted to have partners at Helion who share this vision, and look forward to leveraging their great experience in building a strong company that may soon graduate to become the world's largest stem cell bank". With this development Mr. Kanwaljit Singh, Senior Managing Director at Helion Advisors would join the LifeCell board. Mr Kanwaljit Singh said, "The investment is in line with our on-going strategy to invest behind high quality entrepreneurs in industries with high growth potential. LifeCell is the pioneer and market leader in a very exciting space. We are pleased to come on board as investors and look forward to working with the Management to help build a world class Company." LifeCell recently emerged as "Most Recommended Stem Cell Bank" by a market research conducted by Nielsen India amongst practicing gynecologists in India in top 8 cities. Helion Venture Partners, is a Mauritius-registered early to mid-stage India focused fund, which manages assets worth $600 million and above. It is one of the most active risk capital players in the country, with a strong focus on consumer-facing and technology ventures. ]]> <![CDATA[Biotech crop hectares grew 100-fold globally: ISAAA]]> https://biospectrumindia.com/reports-white-papers/95/1377/biotech-crop-hectares-grew-100-fold-globally-isaaa.html https://biospectrumindia.com/reports-white-papers/95/1377/biotech-crop-hectares-grew-100-fold-globally-isaaa.html Thu, 21 Feb 2013 12:58:00 +0530 The report 'Global Status of Commercialized Biotech/GM Crops' released by Clive James, founder and chair of ISAAA on February 20, 2013 at Manilla, Philipines, revelaed an unprecedented 100-fold increase in biotech crop hectarage from 1.7 million hectares in 1996 to 170 million hectares in 2012. That too at an annual growth rate of 6%, up 10.3 million from 160 million hectares in 2011, as per report made biotech crops, the fastest adopted crop technology in recent history. On India, the report stated that the country grew a record 10.8 million hectares of Bt cotton with an adoption rate of 93%, whilst 7.2 million small resource-poor farmers in China grew 4.0 million hectares of Bt cotton with an adoption rate of 80%, cultivating on average 0.5 hectare per farmer. India enhanced farm income from Bt cotton by US$12.6 billion in the period 2002 to 2011 and US$3.2 billion in 2011 alone. "In the period 1996 to 2012, millions of farmers in ~30 countries worldwide, made more than 100 million independent decisions to plant an accumulated hectarage of more than 1.5 billion hectares - 50% more than the land mass of the US or China; this demonstrates the trust and confidence of millions of risk-averse farmers in biotech crops which deliver sustainable and substantial, socioeconomic and environmental benefits.", said the report. The report put the global value of biotech seed alone at US$15 billion in 2012. It cited that lack of appropriate, science-based and cost/time-effective regulatory systems as major constraint to adoption. Therefore, it recommended responsible, rigorous but not onerous, regulation for small and poor developing countries. According to the report, two new countries, Sudan (Bt cotton) and Cuba (Bt maize) planted for the first time in 2012. Germany and Sweden could not plant the potato "Amflora" because it ceased to be marketed; Poland discontinued planting Bt maize because of regulation constraints. Of the 28 countries which planted biotech crops in 2012, 20 were developing and 8 were industrial countries; this compares with 19 developing and 10 industrial in 2011. In 2012, a record 17.3 million farmers, up 0.6 million from 2011, grew biotech crops - remarkably over 90%, or over 15 million, were small resource-poor farmers in developing countries. Farmers are the masters of risk aversion and in 2012, a record 7.2 million small farmers in China and another 7.2 million in India, elected to plant almost 15 million hectares of Bt cotton, because of the significant benefits it offers. For the first time, developing countries grew more, 52%, of global biotech crops in 2012 than industrial countries at 48%. In 2012, growth rate for biotech crops was at least three times as fast, and five times as large in developing countries, at 11% or 8.7 million hectares, versus 3% or 1.6 million hectares in industrial countries. Stacked traits are an important feature - 13 countries planted biotech crops with two or more traits in 2012, and encouragingly, 10 of the 13 were developing countries - 43.7 million hectares, or more than a quarter, of the 170 million hectares were stacked in 2012.Brazil, for the fourth consecutive year, was the engine of growth globally, increasing its hectarage of biotech crops more than any other country - an impressive record increase of 6.3 million hectares, up 21% from 2011, reaching 36.6 million hectares. The US continued to be the lead country with 69.5 million hectares, with an average 90% adoption across all crops. Impact of US 2012 drought for maize was 21% loss in productivity and in soybean,12%. Canada had a record 8.4 million hectares of canola at a record 97.5% adoption. Africa continued to make progress with South Africa increasing its biotech area by a record 0.6 million hectares to reach 2.9 million hectares; Sudan joined South Africa, Burkina Faso and Egypt, to bring the total number of African biotech countries to four. Five EU countries planted a record 129,071 hectares of biotech Bt maize, up 13% from 2011. Spain led the EU with 116,307 hectares of Bt maize, up 20% from 2011. The report is cautiously optimistic with more modest annual gains predicted because of the already high rate of adoption in all the principal crops in mature markets in both developing and industrial countries. ]]> <![CDATA[GSK Pharma announces Q4 results]]> https://biospectrumindia.com/news/95/7361/gsk-pharma-announces-q4-results.html https://biospectrumindia.com/news/95/7361/gsk-pharma-announces-q4-results.html Wed, 20 Feb 2013 16:37:00 +0530 GlaxoSmithKline Pharmaceuticals, the Indian arm of the UK-based drug maker GlaxoSmithKline, announced its financial results for the fourth quarter ended December 31, 2012. The growth in net sales was 16 percent and profit after tax and before exceptional items was 7.4 percent. The core pharmaceuticals business grew by 15.9 percent for the quarter. For the year ended December 31 2012, the growth in net sales was 11.2 percent and profit after tax and before exceptional items was 7.3 percent, while the core Pharmaceuticals business grew by 12.5 percent. Commenting on the performance, Dr Hasit B Joshipura, managing director, said, "In 2012, growth was broad based across the company. Mass markets grew well. Vaccines continued the growth momentum by growing ahead of the market." Despite a challenging operating environment, material cost increases and significant investments in field force expansion, profit before exceptional items and tax grew by 7.3 percent and profit before investment income, depreciation and tax amounted to 32 percent of net sales. In 2012, the company added new products across therapeutic areas. The company launched Altargo in the dermatology portfolio; Volibris (Ambrisentan), a non-sulphonamide class endothelin receptor antagonist (ERA) to treat pulmonary arterial hypertension (PAH); Hycamtin to fulfil unmet needs for patients with advance cancers and relapsed small cell lung cancer (SCLC); Seretide Evohaler - a Metered Dose Inhaler (MDI) with dose counter to help patients keep a correct count of drug doses taken. The company forayed in CNS through the launch of Lamictal, a newer epileptic drug for treatment of partial and generalized seizures in children and adults. It is also used in bipolar disorder for preventing mood episodes like depression and mania. Branded generics were added to the range of products - Zimvir for herpes, Uriscostat for gout, IVfer for iron deficiency and Ictacetam for epilepsy. The board recommended a dividend of Rs 50 per equity share for the year (previous year: Rs 45 per equity share). If approved by the shareholders at the Annual General Meeting, the dividend will absorb Rs 424 crore. The dividend distribution tax borne by the company will amount to Rs 64 crore. ]]> <![CDATA["India has the fastest growing online healthcare market"]]> https://biospectrumindia.com/interviews/95/6576/india-has-the-fastest-growing-online-healthcare-market.html https://biospectrumindia.com/interviews/95/6576/india-has-the-fastest-growing-online-healthcare-market.html Wed, 20 Feb 2013 14:19:00 +0530 Indegene offers scientific partnership to global life science companies by delivering a spectrum of medical, marketing, training, intelligence, and analytics services. Mr Manish Gupta, CEO, Indegene has more than 15 years of experience. He has pioneered the application of robust and scalable operational processes to the domain of pharmaceutical commercialization and scientific services. At Indegene, he is responsible for general operations, investor relations, and driving the overall strategy of the company. Excerpts of the interview. With respect to Indian context, how potent do you think is social media in pharma companies? How can social media analytics help in understanding the market dynamics for the Indian industry? A recent COMSCORE report places India as the fastest growing online market amongst Brazil, Russia, India and China (BRIC) nations, and has a 10 percent penetration rate. The health sector has experienced 43 percent YOY growth over the last 12 months, positioning both users and the healthcare industry as prominent users of internet-based information and networking. Since patients are already widely using the internet to search for information, pharma companies have realized the need to understand sentiments and be present where their customers are already active. Social media in pharma is very different from how one may use popular social networking sites, as there is significant risk and compliance that must be ensured to effectively engage stakeholders. We, at Indegene have a tremendous applied understanding of how this needs to be done from experience, conceptualizing to building and implementing client programs across market places, including India. Can you name a few examples where social media has been used effectively by Indian companies? Since the evolution of social media in the Indian market, there have been several successful campaigns. For example - Cipla's "Breathe Free Diwali Campaign" was a public initiative by Cipla in order to create the awareness of harmful effects of diwali cracker smoke to asthmatics. Other early movers in the Asia Pacific Region (APAC) markets have been AstraZeneca, Merck, and Sanofi. Lastly, what is your outlook for India as compared to other countries in the APAC region in the next few years? Do you see the pharma and biotech scene progressing or stagnating? The Indian healthcare sector is worth $158 billion and is expected to grow at a CAGR of 15 percent over the next few years. It is estimated that the marketplace will be worth $280 billion by 2020, which will contribute eight percent of GDP. The Indian pharmaceutical market has emerged as the 10th fastest growing pharma market. With all stakeholders including providers, payers, pharmaceuticals, and patients changing, the Indian market place is becoming very unique. Patients continue to contribute about 85 percent of healthcare expenditure out-of-pocket. Currently, branded generics, for example, occupy 70-80 percent of market and local players enjoy dominant position, creating intense competition amongst local firms and their multinational counterparts. There is still a very large gap that exists between demand and supply, and this has made the Indian market place an important area for pharma, providers and payers. ]]> <![CDATA[Terror angle to fake drugs: Experts]]> https://biospectrumindia.com/news/95/3085/terror-angle-to-fake-drugs-experts.html https://biospectrumindia.com/news/95/3085/terror-angle-to-fake-drugs-experts.html Tue, 19 Feb 2013 13:38:00 +0530 "The counterfeiting of drugs is not a simple issue of producing fake drugs but can have other dimensions as well. It is being said that the terrorists and anti-social elements can weaken the economy by using this modus operandi," stated Dr Praful Naik, chief scientific officer (CSO), Bilcare Research, who spoke at the open house consultation organized recently by the Partnership for Safe Medicine (PSM) at New Delhi. This revelation makes the issue far more serious and many experts feel that there must be a mechanism to put timely checks on the illegal activities. Moreover, enacting strict laws is also an option that is being seriously considered by the authorities. "Technology measures have to be taken. A review is needed for the existing techniques. Accountability on part of manufacturers is a very important part of this cycle," mentioned Dr Naik, who is also a member of the national working group constituted by the principal scientific adviser to the government of India for scientific and technological measures to counter spurious and sub-standard drugs and diagnostic centres. At the same time confusion prevails among various stake holders in distinguishing the spurious or substandard drugs and fake drugs. According to Mr Dilip G Shah, secretary general, Indian Pharmaceutical Alliance, "Substandard drugs are not any illegal activity and it has to be considered as a technical failure. In few cases, small units are not always able to provide technically qualified employees, resulting in some issues with the final product that is not entirely fake. The true intention may not to be to produce such drugs, but could have happened due to various lacking points, such as infrastructure or the other basic issues." "However, fake drugs are a huge risk and have to be tracked and traced to ensure that these don't get mixed up with our supply chain and healthcare." added Mr Shah. ]]> <![CDATA[Greater technical thrust needed in agriculture: Pawar]]> https://biospectrumindia.com/news/95/3109/greater-technical-thrust-needed-in-agriculture-pawar.html https://biospectrumindia.com/news/95/3109/greater-technical-thrust-needed-in-agriculture-pawar.html Mon, 18 Feb 2013 21:48:00 +0530 While addressing the 84th Annual General Meeting (AGM) of Indian Council for Agricultural Research (ICAR) at Delhi, the agriculture and food processing industries minister, Mr Sharad Pawar, on February 18, 2013, called for greater technical thrust in agricultural sector . He said, "The 12th Plan accepts the proposition that a greater technical thrust is needed, and the strategy for agriculture should take this into account. In order to provide scientific focus to some of the critical areas, research consortia platforms are to be launched in seed, diagnostics and vaccines, nanotechnology, bio-fortification, agri-incubators, water, natural fibers, health foods, hybrids, secondary agriculture, farm mechanization, precision farming and energy, genomics, molecular breeding and agro-biodiversity." The minister added further, "This has been a momentous year for the national agricultural research system and the Indian agriculture. I wish to inform the august house that ICAR has established the National Institute for Biotic Stress Management at Raipur in Chhattisgarh, Indian Institute of Agricultural Biotechnology at Ranchi in Jharkhand, Regional Research Station of Central Arid Zone Research Institute (CAZRI) for cold arid agriculture in Leh, Jammu & Kashmir and five new Krishi Vigyan Kendras (KVKs), one each in Andhra Pradesh, Jammu & Kashmir, Orissa, Maharashtra and Karnataka, raising their total to 631 KVKs across the country. The ICAR has also added 19 new Experimental Learning Units to the existing 264 units in 51 state agricultural universities and created a centralized statistical and computational genomics lab facility." He also called upon the state ministers, "to ensure that the respective state agricultural universities are adequately funded and staffed so that the efforts to improve the quality of education are synergized. We feel that participation of the private sector is also essential to raise the level of investments in agricultural research and education." The minister said, "The vast network of agricultural universities and colleges can play a leading role in cultivating self-confidence and capabilities in the students required for taking up agriculture as a profession." The minister further said, " The success of research lies in our production figures. I am happy to inform you that agriculture and allied sector in 11th Plan has seen phenomenal growth rate of 3.7 percent as against 2.4 percent in 10th Plan. In fact, if we exclude the forestry sector, then agricultural sector growth is 3.8 percent which is very close to the targeted 4 percent. Indications are that we are going to have a reasonably good wheat crop this year which should bring happiness for everyone." The minister expressed his confidence that, "The proactive initiatives taken by the Council will help us to achieve a robust agriculture to ensure food, nutritional and livelihood security for millions of our countrymen. In addition to being world's largest agricultural research institutions, let Indian Council of Agricultural Research to be one of the world's largest research institutions and said that the Government is fully committed to support its efforts through adequate resources and sufficient autonomy." The meeting was also attended by ministers of state for agriculture, Mr Tariq Anwar and Dr Charan Das Mahant. Other dignitaries who attended the meeting were Dr S Ayyappan, secretary, Department of Agricultural Research and Education (DARE) and director general, ICAR; agriculture and animal husbandry ministers of various states and representatives from international organizations. ]]> <![CDATA[Indian Immunologicals looks at tapping JE market ]]> https://biospectrumindia.com/news/95/1248/indian-immunologicals-looks-at-tapping-je-market-.html https://biospectrumindia.com/news/95/1248/indian-immunologicals-looks-at-tapping-je-market-.html Mon, 18 Feb 2013 13:27:00 +0530 Japanese Encephalitis (JE) is a major debilitating disease affecting thousands of people across India each year. Expert study from 1978-2011 reveals that, India had 1, 25,030 cases of Japanese Encephalitis as against Nepal which reports 40,431 cases. Now with an eye on the market and putting across the latest research trends across medical fraternity, Indian Immunologicals which has a JE vaccine in pipeline, recently initiated an awareness campaign on the disease with a seminar for over 100 doctors in Delhi on February 15, 2013. Present on the occasion was Dr Nagabhushana Rao, an international clinical expert on Acute Encephalitis Syndrome (AES), Japanese encephalitis and epidemic brain attacks. Dr Rao presented his research findings at the event. Dr Rao's study stated that many states and union territories of India have witnessed cases of AES but have not yet reported. The states that did not report AES were Arunachal Pradesh, Chattisgarh, Gujarat, Himachal Pradesh, Jammu and Kashmir, Madhya Pradesh, Meghalya, Mizoram, Odisha, Rajasthan, Sikkim and Tripura. Union Territories of India that did not report AES were Andaman and Nicobar Islands, Chandigarh, Dadra and Nagar Haveli, Daman and Diu and Pondicherry. Speaking on the occasion, Dr Rao said, "Japanese encephalitis is a leading cause of viral encephalitis in Asia with 30,000-50,000 clinical cases reported annually. In India 3,803 cases of Japanese encephalitis were reported in 2012, the deadly virus has so far claimed 674 lives. There were a maximum of 1,169 deaths due to the virus in 2011, 679 in 2010 and 774 in 2009. Uttar Pradesh had the maximum of 579 deaths in 2011, while Assam had reported 250 deaths and Bihar 197." The seminar also highlighted about other emerging infectious diseases by eminent medical speakers such as Dr Durga Madhav Sathpathy, professor from Bhubhaneshwar Medical College and an expert on Rabies; and Dr Mahaveer Jain, a leading pediatrician and former secretary of Indian Association of Pediatricians. During the seminar, Dr Rao reported that JE is found mainly from Assam, Bihar, Karnataka, Tamil Nadu and Uttar Pradesh which account for approximately 80 percent of cases and deaths with a case fatality rate ranging from 20 to 25 percent. Dr Rao suggested that vaccination against JE needed to continue, as it was a mainly a rural phenomenon, amplified by biological agents such as pigs, ducks, and mosquitoes which cannot be eliminated. ]]> <![CDATA[Aanjaneya Lifecare bags Global Peacock Award 2012]]> https://biospectrumindia.com/news/95/8018/aanjaneya-lifecare-bags-global-peacock-award-2012.html https://biospectrumindia.com/news/95/8018/aanjaneya-lifecare-bags-global-peacock-award-2012.html Mon, 18 Feb 2013 12:31:43 +0530 Mumbai-based Aanjaneya Lifecare, the vertically integrated pharma company with manufacturing and marketing capabilities in APIs with focus on anti-malarial and finished dosage forms (FDFs) catering to various therapeutic segments, has received the Golden Peacock National Quality Award-2012 in Bangalore on February 8, 2013 in the presence of business leaders, jurists, academics, environmentalists, economists, legislators and policy makers during the 23rd World Congress on Leadership and Quality of Governance. Aanjaneya Lifecare has been selected as the winner of the 'Golden Peacock National Quality Award' on account of its formidable growth momentum under tough business environment for the year 2012 by the awards jury under the chairmanship of justice PN Bhagwati, former chief justice of India and member, UN Human Rights Commission, Justice MN Venkatachaliah, chairman, IOD Advisory Council and former chief justice of India were among the judging panel for this year's Golden Peacock Awards. The coveted award was received by Mr Kashi Vishwanath, chairman of Aanjaneya Lifecare. On receiving the award, Dr Kannan Vishwanath, vice-chairman and MD, Aanjaneya Lifecare said, "This coveted title of Golden Peacock National Quality Awards reflect the resounding success of Aanjaneya Lifecare in the pharmaceutical industry in a short span of time and meeting the tough global challenges of keeping the winning momentum, This Award is a standing testimony of the entire Aanjaneya Lifecare's internal and external stakeholders who have reposed faith in our organization." The Golden Peacock Awards is a set of prestigious national and global awards designed to improve productivity and quality in organizations. ]]> <![CDATA[Bayer Animal Health launches all-in-one parasiticide]]> https://biospectrumindia.com/news/95/1001/bayer-animal-health-launches-all-in-one-parasiticide.html https://biospectrumindia.com/news/95/1001/bayer-animal-health-launches-all-in-one-parasiticide.html Mon, 18 Feb 2013 11:47:49 +0530 For the first time in Indian market, Bayer Animal Health has introduced Advocate, a most comprehensive endectocide for dogs and cats. Advocate offers vets and pet owners the most complete parasite solution in a unique, easy to use topical formulation. First launched in Australia in 2004, Advocate has greatly enhanced a growing segment in endo and ecto-parasite protection and treatment, and is a top-performer in core markets in which it has been introduced. Advocate offers prevention and treatment for an array of endo- and ectoparasites prevalent in India, including flea infestation (Ctenocephalidesfelis) and intestinal nematodes, such as hookworm, roundworm and whipworm. It is also effective in the treatment of various life stages of gastrointestinal nematodes. Furthermore, it acts against ear mite infestation (Otodectescynotis), sarcoptic mange and demodicosis (both in dogs) and can be used as a heartworm preventative (L3 and L4 larvae of Dirofilariaimmitis) medication in dogs and cats. Mr Rajesh Aggarwal, Country group head, Southern Asia for Animal Health says, "One of the many challenges we face in veterinary medicine is developing products that are effective against a range of parasites - including the most difficult ones to treat - that are also well tolerated by the animal under treatment. Then, thinking about how best we can promote compliance, particularly with pet owners, by making our products easy to administer." "Advocate is an important achievement, the result of our scientific rigour and deep understanding of animal health, in particular parasites. This broad spectrum endo-ectoparasiticide can be used not only to treat pets already infected with some of the most common parasites, but also as a preventative measure. It is the sort of product small animal practices should have to hand due to its scope as well as its suitability as a lifelong treatment for cats and dogs." Advocate combines imidacloprid (10 percent) and moxidectin (1 percent in cats and 2.5 percent in dogs) in a topical formulation licensed for use on dogs from seven weeks of age and cats from nine weeks of age, with a minimum body weight of 1kg in each species. It is available in 4.0 ml, 2.5 ml (both for dogs) and 0.8 ml (for cats) single pipette packs, the varying pipette sizes are for differing pet weights. The parasitic treatment is applied directly to the skin and on the back of the animal to minimise the opportunity for the product to be licked off. ]]> <![CDATA[ITS launches guidelines to tackle thyroid dysfunctions]]> https://biospectrumindia.com/news/95/7251/its-launches-guidelines-to-tackle-thyroid-dysfunctions.html https://biospectrumindia.com/news/95/7251/its-launches-guidelines-to-tackle-thyroid-dysfunctions.html Mon, 18 Feb 2013 11:17:16 +0530 The Indian Thyroid Society (ITS) has launched three guidelines for the management of thyroid dysfunction in pregnancy, dyslipidemia and depression at the 10th Annual Conference 'ITSCON - 2013'. These guidelines are for managing thyroid dysfunction in pregnancy to safeguard mother and child health, and for patients of depression and dyslipidemia to reduce the co-morbidities associated with thyroid disorders. Thyroid disorders in India are characterized by a high prevalence (approximately 11 percent of adult population), minimal diagnosis, low awareness and low involvement of doctors in treatment. The guidelines were developed by Elsevier, a global provider of scientific, technical and medical information, and endorsed by the ITS, Endocrine Society of India [ESI], Federation of Obstetric and Gynecological Societies of India [FOGSI] and The Association of Physicians of India [API]. Abbott provided the financial assistance for the development of these guidelines. On the launch of the ITS Guidelines, Dr RV Jayakumar, president, Indian Thyroid Society, professor of Endocrinology, AIMS, Cochin said, "Conditions such as depression, cardiovascular disorders, high cholesterol, obesity, osteoporosis, infertility and miscarriages are linked to thyroid disorders and these are on the rise in India. The three independent guidelines for the screening and management of thyroid dysfunction will support the medical fraternity in diagnosis and treatment. Timely diagnosis of thyroid disorders in pregnant women is important for a healthy pregnancy and a healthy child. In addition, the guidelines for dyslipidemia and depression offer recommendations to minimize the risk of arising complications." Dr Mala Dharmalingam, professor and HOD of Endocrinology, MS Ramaiah Medical College and Hospital, Bangalore says, "Thyroid hormone is very important for normal functioning of the body processes. However, low production of the hormone leads to hypothyroidism indicated by fatigue, weight gain, cold chills, dry skin, heavy menstrual periods, constipation, slowed thinking, brittle nails, swelling in arms and legs and hair loss. Ignoring these symptoms can develop into serious medical conditions like heart disease, and mental health issues. Through these guidelines we can create awareness amongst the general public about symptoms related to thyroid disorders and the complications that can arise if not diagnosed and treated in time." The Thyroid Dysfunction and Pregnancy Guidelines recommend the following: For the screening for hypothyroidism in pregnant women at the 1st antenatal visit by measuring TSH levels. If overt hypothyroidism is diagnosed then expectant mothers should be treated with a full replacement dose of thyroxine to normalize thyroid function as rapidly as possible. It is also important to understand that; thyroid dysfunction by itself is not an indication for termination of pregnancy. Overt hypothyroidism is associated with the risk of cardio vascular disease as it causes increased levels of LDL cholesterol and hypertension. It is therefore advised that doctors screen patients with dyslipidemia for abnormal thyroid levels and accordingly prescribe treatment. One of the co-morbidities associated with thyroid disorders is depression. It is important for doctors who are treating patients for depression to refer them to undergo a TSH test to detect hypothyroidism. This will help in correct diagnosis and treatment to prevent further damage. Thyroid disorder is a medical condition that impairs the normal functioning of the thyroid gland causing abnormal production of hormones leading to hyperthyroidism or hypothyroidism. Multiple factors such as hereditary, environment and diet can trigger thyroid dysfunction. Thyroid disorders are commonly diagnosed between 20-40 years and research has shown that women are more commonly detected with thyroid disorders than men. Speaking of thyroid disorders in women during pregnancy, Dr Hema Divakar, president, Federation of Obstetric and Gynaecological Societies of India [FOGSI], Bangalore said, "Hypothyroidism is emerging as one of the most common endocrine problem during pregnancy and often goes undetected. It increases the risk of miscarriage, stillbirth, premature birth and placental abnormalities that adversely affects the overall development of the fetus. In the best interest of the mother and baby, we encourage regular screening for thyroid disorders amongst pregnant women. The guidelines recommend screening at the 1st antenatal visit by measuring TSH levels." Often symptoms such as anxiety, mood swings and poor concentration are ignored as signs of stress. These could have been triggered due to abnormal levels of thyroid hormone which can push people into depression. According to Dr Sarita Bajaj, president, Endocrine Society of India (ESI), Allahabad, "Thyroid hormones have a tremendous effect on body processes and can even impact cognitive function. There is little awareness that depression is a co-morbidity associated with hypothyroidism. All patients with depression should preferably be screened for thyroid function tests and be appropriately treated with thyroxine as judged by the physician." Hypothyroidism also leads to a co-morbid condition called dyslipidemia indicated with an increase in serum total cholesterol, low-density lipoprotein (LDL), apolipoprotein B, lipoprotein (a) levels, and possibly triglyceride levels. Dyslipidemia puts a patient at an increased risk for developing cardiovascular diseases, atherosclerosis and coronary artery disease. The chairman organizing committee Dr KM Prasanna Kumar confirmed that close to 500 eminent speakers and key opinion leaders from across India were present at the ITSCON-2013 conference. The speakers highlighted various disorders arising from thyroid dysfunctions, the importance of timely screening and recommended treatment to prevent further complications. Till 2012, Indian Thyroid Society had screened close to 12 lakh women for thyroid disorders at various diagnostic and education camps throughout India. ]]> <![CDATA[New UK-India initiative to tackle brain disorders]]> https://biospectrumindia.com/news/95/3084/new-uk-india-initiative-to-tackle-brain-disorders.html https://biospectrumindia.com/news/95/3084/new-uk-india-initiative-to-tackle-brain-disorders.html Sat, 16 Feb 2013 01:11:00 +0530 Brain disorders such as autism and dementia could be better understood thanks to an international partnership that will research the conditions. Scientists from the University of Edinburgh and the Institute of Stem Cell Biology and Regenerative Medicine (inStem) in Bangalore are to form a new centre to study disabilities that arise from alterations in brain development. Autism spectrum disorders and intellectual disabilities will be the initial focus of the Centre for Brain Development and Repair, which will be based in Bangalore. In the longer term, the centre will train scientists to tackle major neurological disorders such as dementia, which can critically undermine quality of life and represents a growing and major public health threat in India. The collaboration will be supported by the Indian Department of Biotechnology and will involve visiting professors from Edinburgh and Indian scientists working on joint projects in Bangalore and Edinburgh. Dr Shona Chattarji, Professor of Neurobiology at the National Centre for Biological Sciences (NCBS), Bangalore and the director of Centre for Brain Development and Repair said, "This Centre is a milestone in UK-India bioscience partnering. It represents a transformative collaborative programme that brings together world-class expertise in several scientific disciplines. This is crucial if we are to understand autism spectrum disorders and intellectual disabilities better." The launch of the centre comes after two years of collaborative work between inStem, the NCBS and the University of Edinburgh. This has resulted in inStem developing new approaches to understanding brain development disorders. Dr Siddarthan Chandran, Professor of Neurology and Director of the University of Edinburgh's Centre for Clinical Brain Sciences, said: "Not only will this centre focus on the common psychiatric and neurological diseases that cause a major burden for patients in both India and the UK, but it will also train the next generation of scientists who will take forward laboratory discoveries to the clinic." ]]> <![CDATA[White biotech: Opportunities and challenges alike]]> https://biospectrumindia.com/views/95/3101/white-biotech-opportunities-and-challenges-alike.html https://biospectrumindia.com/views/95/3101/white-biotech-opportunities-and-challenges-alike.html Fri, 15 Feb 2013 17:29:29 +0530 There is a growing need for sustainable solutions in India. Keeping in mind the specific needs of Indian market, Novozymes will continue to focus on developing specific local applications using our R&D and applications labs. We see exciting opportunities in the food and beverages, household care, textiles industries and the biofuels sector. Novozymes is the leader in the BioIndustrial sector and the business has been growing consistently year after year in India. While there are many opportunities for growth within the segment, the regulatory challenges and approval process for implementing new innovation in certain segments makes the going tough for the industry. - Mr GS Krishnan, regional president, Novozymes South Asia 2013 looks to be a "path breaking" year for Advanced Enzyme Technologies in almost all the aspects of our business. We began our journey of becoming a true global company since 2011 and 2012 turned out great year when we completed construction of South East Asia's largest enzyme manufacturing plant at Indore SEZ. We not only acquired one more American company specialized in enzyme-based nutritional care, but also got awarded as 1st runner up "Innovative Exporter of India" by Export Credit Guarantee Corporation of India (ECGC) . We are expecting to acquire an European enzyme company during 2013 and start serving much bigger European, CIS, Middle East, and Africa market. We sincerely expect a big jump in our technological offerings and also robust increase in sales as well as profits of the company. We are also looking to complete our IPO during 2013. - Mr CL Rathi, managing director, Advanced Enzyme Technologies ]]> <![CDATA[Drug counterfeiting is a criminal act: PSM report]]> https://biospectrumindia.com/reports-white-papers/95/3217/drug-counterfeiting-is-a-criminal-act-psm-report.html https://biospectrumindia.com/reports-white-papers/95/3217/drug-counterfeiting-is-a-criminal-act-psm-report.html Fri, 15 Feb 2013 17:23:00 +0530 According to a report by the Partnership for Safe Medicine (PSM) India on "Patient Safety and Drug Detection Technology" released on 15th February 2013 at New Delhi by Mr Keshav Desiraju, secretary, ministry of health and family welfare, India has more than 10,000 manufacturers of pharmaceutical products, but very few qualify the standards of Good Manufacturing Practices (GMP). Speaking at open house consultations on "Accessibility to quality medicines in the supply chain", where the report was released, Mr Bejon Misra, founder, PSM India said, "The real challenge is to change the mind-set of the small scale manufacturing units and make them understand that manufacturing good quality medicines will fetch profit and bring good return on investments rather than perpetually living under the threat of the law enforcers or in the mercy of the unscrupulous traders/retailers." Mr Desiraju outlined that few manufactures think that it is not their concern and regulators only have the responsibility to catch the culprits. "But that must not be the case. Counterfeiting is a criminal act and should be treated like one. There has to be a common goal in ensuring the safe and quality medicines and we are all part of this society. We are moving into the direction of enforcing technology as mandatory for tracking and tracing," he told BioSpectrum. The report of the International Workshop held in India in September 2012 had emphasized that 2D bar coding and a unique universal product identification system should become mandatory under the provisions of the existing Indian Drugs and Cosmetics Act. There are also no provisions relating to the same for imported drugs, which should also get included into the existing law. To facilitate efficient drug recalls, global standards and best regulatory practices, India must adopt a sound track and trace system across the supply chain. This will not only provide safety and quality medicines to the patients but also improve tax collection from pharmaceutical products and reduce drastically not-of-standards or spurious medicines from the supply chain. The report mentioned that government of India should also expedite the process of implementation of effective 'track and trace' systems already made mandatory for all products meant for exports and domestic products which are under price control. The technology to be selected should be vendor neutral, based on best global standards, simple in implementation and affordable, especially for the small scale manufacturers. The PSM report recommended that adequate reference standards need to be made available to laboratories to keep up with new types of formulations and Indian regulatory officials should be invited as observers in the inspections of manufacturing sites by European Union, US FDA and regulatory agencies of other countries. ]]> <![CDATA[Indian patients can now get their drugs tested]]> https://biospectrumindia.com/news/95/3096/indian-patients-can-now-get-their-drugs-tested.html https://biospectrumindia.com/news/95/3096/indian-patients-can-now-get-their-drugs-tested.html Fri, 15 Feb 2013 16:32:00 +0530 Firm on its advocacy for uniform standards for drugs with tracing and tracking system, India chapter of Partnership for Safe Medicine (PSM) is set to launch a pilot project in India to enable patients to get their medicines tested. The move is meant to enhance trust between manufacturers and consumers and find the extent of spurious medicines in circulation in India. A draft proposed methodology was released at New Delhi on February 15, 2013, for public comments and wide circulation amongst all the stakeholders, prior to its official launch. This proposed innovative initiative will be launched as a pilot to study the extent of spurious and not-of-standards medicines in India and adopt policies to ensure safety and quality in the supply chain. "This will establish trust on the quality and existing regulatory standards between the manufacturers and the consumers," said Mr PD Sheth, vice president of the International Pharmaceutical Federation. PSM India Initiative has also strongly demanded formulation of global best standards for exported and domestic drugs made available in the supply chain through a robust detection technology to promote universal product identification system under the Indian Drugs and Cosmetics Act, and enable consumers to distinguish between spurious and genuine medicines. ]]> <![CDATA[Bill Gates:Next Challenge is Malaria]]> https://biospectrumindia.com/news/95/4787/bill-gatesnext-challenge-is-malaria.html https://biospectrumindia.com/news/95/4787/bill-gatesnext-challenge-is-malaria.html Fri, 15 Feb 2013 14:16:25 +0530 Known as the 2nd richest man in world, with an estimated net worth of $66 billion, Bill Gates, co-chair of the Bill and Melinda Gates Foundation(BMGF) is not the easiest man to gain access to. However 4 days ago, in a unique initiative he reached out to the general public through the social news and entertainment website,Reddit, with a blanket, "Ask me anything", thus throwing open the floor to an interesting discussion, ranging from his outlook of India, his ideas for increasing access to vaccines, and how once polio is eradicated, he has set his eyes on fighting malaria. About vaccination strategies in India,where BMGF is closely involved in the polio eradication efforts,Bill Gates said, a lot still needs to be done. He added, "India is making progress but there is still a lot to do particularly up in the North. They still need to add some of the vaccines that poorer countries are already using and saving lots of lives. India did a great job on polio and is increasing the health budget. We work closely with the federal and state governments to help out..." BMGF is also closely associated with the Bharat Biotech' s path breaking Rotavirus vaccine project as one of its the funding partners. Bharat Biotech hopes to offer the vaccine at $1 per dose by 2014. Malaria is an important goal for him, as he has noted in a previous interview, that he wants a malaria vaccine to be developed , which can be then distributed to those who need it. He elaborated further to a question during the exchange, "Polio is the first thing to get done since we are close. Within 6 years we will have the last case. After that we will go after malaria and measles. Malaria kills over 500,000 kids every year mostly in Africa and did not get enough attention until the last decade. We also need vaccines to prevent HIV and TB which are making progress." He counts the success of polio eradication as one of the greatest achievements of the BMGF,"So far our biggest impact has been getting vaccines for things like diarrhea and pneumonia out which has saved millions of lives. Polio will be a great achievement along with key partners when that gets done." Along the way, he also touched upon topics as diverse as his portrayal in a Hollywood movie, his bucket list and how cheeseburgers are among the cheapest things that give him pleasure. ]]> <![CDATA[Dr Reddy's records 47% growth in Biosimilars portfolio in Q3]]> https://biospectrumindia.com/news/95/6521/dr-reddys-records-47-growth-in-biosimilars-portfolio-in-q3.html https://biospectrumindia.com/news/95/6521/dr-reddys-records-47-growth-in-biosimilars-portfolio-in-q3.html Fri, 15 Feb 2013 12:40:44 +0530 Dr Reddy's Laboratories, an integrated global pharmaceutical company having interests in biosimilars has registered high growth of 47 percent from its biosimilar portfolio for third quarter ending December 31, 2012 over the same period last year. Dr Reddy's Labs, through its three businesses Pharmaceutical Services and Active Ingredients, Global Generics and Proprietary Products, offers a portfolio of products and services including APIs, custom pharmaceutical services, generics, biosimilars, differentiated formulations and NCEs. Biosimilar portfolio consists of four products namely - Grafeel, Reditux, Cresp and Peg-grafeel. Besides biosimilars, it has other therapeutic focus ie is on gastro¬intestinal, cardiovascular, diabetology, oncology, pain management, anti¬infective and pediatrics. Major markets include India, USA, Russia and CIS, Germany, UK, Venezuela, S. Africa, Romania, and New Zealand. The consolidated revenues for third quarter FY13 of Dr Reddy's Laboratories, stood at Rs 28.7 billion, recorded Year on Year (YoY) growth of 23 percent. Revenues from the Global Generics segment for Q3 FY13 at Rs.20.8 billion, recorded a YoY growth of 24 percent primarily driven by North America and the Emerging market territories. During the quarter, the company launched 17 new products, filed 13 new product registrations and filed 13 DMFs globally. The company noted that the revenues from North America for Q3 FY13 at Rs 9.2 billion ($178 million), recorded YoY growth of 38 percent. The release further said that the growth is largely driven by key limited competition products of ziprasidone, tacrolimus, fondaparinux and ramp-up in antibiotics portfolio and continued focus on gaining market shares of new products such as atorvastatin, metoprolol, ibandronate and montelukast granules during the quarter. During the quarter, 4 ANDAs were filed. Cumulatively, 65 ANDAs are pending for approval with the USFDA of which 35 are Para IVs and 8 have 'First To File' status. Revenues from the emerging markets such as Russia and Other CIS markets for Q3 FY13 stood at Rs 4.4 billion recorded YoY growth of 32 percent. Revenues from Russia alone for Q3 FY13 stood at Rs 3.7 billion recorded YoY growth of 35 percent, largely aided by seasonal offtake across major brands and new product launches. Revenues from Other CIS markets for Q3 FY13 stood at Rs 0.7 billion recorded YoY growth of 19 percent. Revenues from India for Q3 FY13 at Rs 3.7 billion recorded YoY growth of 12 percent. The company launched eight new brands during the quarter. Revenues from Europe for Q3 FY13 at Rs.1.9 billion declined YoY by 20 percent. The company's revenues from Pharmaceutical Services and Active Ingredients (PSAI) for Q3 FY13 stood at Rs.7.1 billion, recorded YoY growth of 28 percent. During the quarter, 13 DMFs were filed globally, including 3 in the US and 1 in Europe. The cumulative number of DMF filings as of December 31, 2012 is 566. ]]> <![CDATA[Kemwell appoints Dr Ninad Deshpanday as new President R&D ]]> https://biospectrumindia.com/news/95/3086/kemwell-appoints-dr-ninad-deshpanday-as-new-president-rd-.html https://biospectrumindia.com/news/95/3086/kemwell-appoints-dr-ninad-deshpanday-as-new-president-rd-.html Fri, 15 Feb 2013 12:06:09 +0530 Kemwell Biopharma, a global pharmaceutical contract development and manufacturing company, announced that it has appointed Dr. Ninad Deshpanday as President of Research and Development. About the appointment, Anurag Bagaria, Chairman and Managing Director of Kemwell said, "Dr. Deshpanday brings a unique combination of leadership skills and technical expertise in pharmaceutical development, as well as excellent business development skills with a very strong network of customers in the US, Europe and Asia. He will spearhead the R&D business for Kemwell as we continue to grow the geographical footprint and strategically position Kemwell into a leading Global Contract Services Provider." Dr. Deshpanday has over 22 years' experience of diverse international experience in the pharmaceutical industry (US + India). This includes pharmaceutical development activities for NDAs, specialty drug delivery based 505(b)(2) products, including Oral and Transdermal, and complex Generic products, with several F2Fs and PIVs. He also has rich experience in Technical and Business Development Prior to joining Kemwell, he was President of Pharmaceutical R&D at Lupin, in Pune, India since November 2007, with leadership responsibilities for formulations, analytical, and BA/BE activities. Before joining Lupin, Dr. Deshpanday was Vice President of Business Development at AAIPharma in RTP, NC, with responsibilities for sales and marketing activities for their CM&C functions; Vice President for Drug Product Development for Synta Pharmaceuticals, with responsibilities for all CM&C activities; and Technical Business Director for the Pharmaceutics division of Cardinal Health. Dr. Deshpanday earned his Doctorate in Pharmaceutics from the University of S. Carolina in 1990, and has an M. Pharm. and B. Pharm. from LM College of Pharmacy in Ahmedabad, India. ]]> <![CDATA[Wockhardt registers 101% growth in profits in Q3FY13 ]]> https://biospectrumindia.com/news/95/3083/wockhardt-registers-101-growth-in-profits-in-q3fy13-.html https://biospectrumindia.com/news/95/3083/wockhardt-registers-101-growth-in-profits-in-q3fy13-.html Fri, 15 Feb 2013 11:57:54 +0530 Wockhardt reported a Profit After Tax in Q3FY13 of Rs.428 crore, thus registering more than 100% growth over the corresponding quarter of Financial Year 2011-12. The Profit After Tax margin stood at 30%. Wockhardt's Operating Profit for Q3FY13 stands at Rs. 545 crore, with Operating Profit Margin at 38.0% for the quarter, one of the highest in the industry and has improved from 31.6% in the corresponding quarter of the previous year. The India business grew by 14% while the overall emerging markets business grew by 18% compared to the corresponding quarter of Financial Year 2011-12. Wockhardt's International Business contributed 83% of the total revenues during the quarter. Additionally, its US business recorded a growth of 45% compared to the corresponding quarter of Financial Year 2011-12 due to niche products. During the quarter the company received 3 product approvals. The R&D expenses for the quarter were at 6.4% to sales and represented a growth of 80% over the corresponding quarter of Financial Year 2011-12. The consolidated revenues grew by 26% to Rs.1,435 crore over the corresponding quarter of Financial Year 2011-12. For the nine Months ended December 31, 2012 (9MFY13), Wockhardt recorded a profit after tax for of Rs. 1259 crore and represented a growth of 136% over same period in the previous year. The operating profit was at Rs.1545 crore for 9MFY13, representing a growth of 61% over same period in the previous year. operating profit margins were at 37.5% for 9MFY13. The consolidated revenues grew by 30% to Rs. 4,124 crores over the corresponding half year of Financial Year 2011-12. ]]> <![CDATA[IGIB to host Genomeet 2013 ]]> https://biospectrumindia.com/news/95/3077/igib-to-host-genomeet-2013-.html https://biospectrumindia.com/news/95/3077/igib-to-host-genomeet-2013-.html Thu, 14 Feb 2013 14:39:00 +0530 Organized by one of the key research institutes of Council for Scientific and Industrial Research (CSIR), Institute of Genomics and Integrative Biology (IGIB), the conference "Genomeet 2013", is expected to be attended by the several leading experts from India and abroad. The conference to be held at New Delhi from March 8-10, 2013, will be focused on the topic "Vitamin B12 and one-carbon metabolism in health and diseases". It would also be an excellent platform for networking with scientists and experts, who will present their latest results which will provide an opportunity to update delegates with the latest advances in this field. The scientific program will consist of various thematic sessions besides poster sessions. A few abstracts will be selected by the scientific committee for oral presentations. The conference will be followed by workshops (hands on training) from March 12-16, 2013 in next generation sequencing and high throughput liquid chromatography-mass spectrometry (LC-MS) based proteomics workflow. The conference comes in the backdrop of the reports from various parts of India that have projected 30-60 percent of the population irrespective of the age group being deficient in Vitamin B12. At the same time, there has been a lack of concerted efforts from the clinicians and researches to understand the importance of this vital vitamin in India and conditions arising due to its deficiency, some of which are trans-generational. Being an important micronutrient linking our diet to health, the deficiency of this vitamin B12 leads to high levels of homocysteine, a key intermediate in the one-carbon metabolism pathway that has been associated with several complex disorders. Therefore, the meeting will deliberate on the genetic, epigenetic and dietary factors that predispose Indians to Vitamin B12 deficiency and hyper-homocysteinemia and provide mechanistic insights on the role of one carbon metabolism in health and disease. ]]> <![CDATA[Sam Pitroda: NIF to get operational by March 2013 ]]> https://biospectrumindia.com/news/95/3046/sam-pitroda-nif-to-get-operational-by-march-2013-.html https://biospectrumindia.com/news/95/3046/sam-pitroda-nif-to-get-operational-by-march-2013-.html Thu, 14 Feb 2013 11:21:00 +0530 "Out of the 20 million jobs that are required at the moment, at least you need to create 10 million new jobs. Ideally, you have to create 15 million new jobs. Where do these jobs come from? You need a large number of entrepreneurs who are solving local problems," Mr Sam Pitroda, who is the advisor to the prime minister on public information infrastructure and innovations, said in his interaction with the media recently at New Delhi. India has about 55 crore young people below the age of 25 years and every year about two crore come out for jobs, he said, adding that new jobs have to come from young entrepreneurs and that these jobs are not going to come from the government. He also said the government will operationalize the National Innovation Fund (NIF) by end of March with an initial capacity of Rs 500 crore. "Ultimately it (the fund) is going to be Rs 5,000 crore fund. We are launching it initially with Rs 500 crore," Mr Pitroda said. The National Innovation Council (NIC) set up by the Prime Minister to create Indian model of innovation, is preparing to launch its fund with an initial corpus of Rs 500 crore shortly and that will lend to companies focusing on delivering goods and services to the poorest people in the country. It is also looking to facilitate creation of Industry Innovation Clusters (IIC) for job creation and productivity. The fund is expected to be operational in the next year. NIC has collaborated with the union ministry of Micro, Small and Medium Enterprises (MSMEs) to steer the fund towards its final stages of approval and an innovative structural design has been developed for the fund. The initial investment prospects are being identified. The fund will be governed by a trust, which will be registered with the Securities and Exchange Board of India (SEBI). Union ministry of finance included Rs 100 crore to kick-start the same in its union budget 2012. About Rs 145 crore has been contributed by public sector banks and financial institutions. The fund will invest directly firms serving Bottom of the Pyramid (BoP) as well as indirectly through BoP-focused funds. It will invest across the venture development cycle - early stage to scale up. It will operate as a 'for profit' entity and give targeted social and economic returns to investors, according to a NIC document on IIIF. Fund will target gross investment Internal Rate of Return (IRR) of 10 percent per annum before taxation and management charges. Fund life is expected to be 10 years, which is extendable by up to three years. The council is also in the process of compiling learnings from seven industry clusters in order to replicate it across industry clusters in the country under IIIC program, which will be a public-private partnership (PPP) model. The pilot phase of this initiative has been operations in seven clusters across the country, which includes auto components (Faridabad, Haryana), Ayurveda (Thrissur, Kerala), Bamboo (Agarthala, Tripura), brassware (Moradabad, UP), food processing (Krishnagiri, Tamil Nadu), Furniture (Ernakulam, Kerala) and life sciences (Ahmedabad, Gujarat). By the end of pilot phase, the aim is to successfully demonstrate 10-12 new products, 7-10 process improvements and two new centres at the clusters. NIC has been working with state governments, MSME and textile ministries, CSIR and Infrastructure Leasing and Financial Services (IL&FS) among others in this effort and is hoping to replicate the innovation cluster model in 80-100 clusters by the end of 2013. ]]> <![CDATA[Biocon, Mylan collaborate for generic insulin analogues worth $11.5 billion]]> https://biospectrumindia.com/news/95/1283/biocon-mylan-collaborate-for-generic-insulin-analogues-worth-11-5-billion.html https://biospectrumindia.com/news/95/1283/biocon-mylan-collaborate-for-generic-insulin-analogues-worth-11-5-billion.html Thu, 14 Feb 2013 11:17:08 +0530 Biocon, Asia's premier biotechnology company has entered into a definitive agreement with Mylan for an exclusive strategic collaboration for the global development and commercialization of generic versions of its three insulin analog products. Under the terms of this collaboration, Mylan will have the rights to develop and market Biocon's Glargine (the generic version of Sanofi's Lantus), Lispro (the generic version of Eli Lilly's Humalog) and Aspart (the generic version of Novo Nordisk's NovoLog). Mylan CEO Heather Bresch commented, "This collaboration builds off of our existing successful partnership for generic biologics with Biocon and brings Mylan a portfolio of high-value insulin analog products. This collaboration further expands and diversifies our pipeline of complex, difficult-to-manufacture products with strong future growth potential. Importantly, we believe we have the opportunity to be one of the first generic entrants in developed markets into the rapidly growing diabetes area, helping to address unmet needs and reduce the economic burden to those battling the disease and to the global healthcare system." In 2009, Biocon had entered into an agreement with Mylan for an exclusive collaboration on the development, manufacturing, supply and commercialization of multiple, high value generic biologic compounds. Biocon's Chairman & Managing Director, Kiran Mazumdar-Shaw said "Mylan is a natural preferred partner for our portfolio of generic Insulin analogs and this collaboration further strengthens our existing successful partnership. We are excited to team up with Mylan to be able to cost effectively address the disease and economic burden that diabetes poses to global health." Mylan and Biocon will share development, capital and certain other costs to bring the products to market. Mylan will have exclusive commercialization rights in the U.S., Canada, Australia, New Zealand, the European Union and the European Free Trade Association countries through a profit share arrangement with Biocon. Mylan will have co-exclusive commercialization rights with Biocon in certain other markets around the world. Mylan President Rajiv Malik added, "Biocon has served as a trusted development partner for the past three years and we are very excited about this expanded relationship. Our thorough review of the development work completed by Biocon to date on these products gives us great confidence in the company's capabilities in this area and in the quality and value of this program. Our confidence in the potential of this program is supported by our proven ability to drive value from our partnership with Biocon and we believe Mylan is uniquely positioned to work with Biocon to bring these products to market." It may be recalled that Biocon has entered into an agreement with Pfizer, the world's biggest pharma company, in October 2010 for a similar kind of agreement. Under the agreement, Pfizer need to pay $200 million (about Rs 900 crore) to have exclusive rights to commercialize several of Biocon's insulin products globally. However, in March 2012, both the firms announced the conclusion of their alliance to commercialize Biocon's biosimilar versions of Insulin and Insulin analog products. The companies have agreed that due to the individual priorities for their respective biosimilars businesses, it is in their best interest to move forward independently. ]]> <![CDATA[Cipla gets patent office nod in Sunitinib case]]> https://biospectrumindia.com/news/95/3679/cipla-gets-patent-office-nod-in-sunitinib-case.html https://biospectrumindia.com/news/95/3679/cipla-gets-patent-office-nod-in-sunitinib-case.html Wed, 13 Feb 2013 17:27:22 +0530 Recently, the Indian patent office rejected Pfizer's claim for a patent on its kidney and liver cancer drug Sunitib. The ruling is effectively in the favor of Cipla, allowing it to manufacture the generic version of the same. Earlier in September 2012, the Supreme Court had revoked a patent held by Sugen (now Pfizer) for its drug Sunitib, citing the absence of any inventive step, that is not obvious to a person skilled in the art. The revocation was closely followed by another High Court order banning Cipla from producing the drug, who produces a much cheaper version. This order was eventually stayed by the Supreme court. Then, in November the Supreme Court ruled that the Pfizer- Cipla Sunitib case be re-examined by the assistant controller of patents at the Patent office. According to newspaper reports, the patent office reiterated its earlier judgement of backing Cipla, in a case that has been closely watched by the pharmaceutical lobby worldwide.With the patent office now upholding earlier decisions in favor of the generics giant, all eyes are on other eagerly awaited verdicts in the pharma space such as the Novartis Glivec case. ]]> <![CDATA[80-90% of vaccines in India are packaged in Schott Kaisha glass]]> https://biospectrumindia.com/news/95/4397/80-90-of-vaccines-in-india-are-packaged-in-schott-kaisha-glass.html https://biospectrumindia.com/news/95/4397/80-90-of-vaccines-in-india-are-packaged-in-schott-kaisha-glass.html Wed, 13 Feb 2013 15:07:25 +0530 Speaking at the recent inauguration of its new pharmaceutical packaging plant in Jambusar, Gujarat, Kairus Dadachanji, Managing Director of SCHOTT KAISHA, said that the plant will cater to not only the pharma industry but also packaging of vaccines and other biologics. Mr.Dadachanji adds,"SCHOTT KAISHA has been supplying packaging vials and ampoules to the majority of the Indian vaccine industry, including companies like Serum Institute of India, Zydus Cadila, Bharat Biotech, Panacea Biotec, Shantha Biotechnics, GSK, Chiron and more.Almost 80-90% of the vaccines that are maufactured in India are packaged in SCHOTT KAISHA glass. It is a matter of great honour for us we play a role in the vaccination of millions of children worldwide ". The Indo-German joint venture, SCHOTT KAISHA is a leading supplier for the pharmaceutical industry offering solution for the entire range of small volume tubular glass parenteral packaging including ampoules, vials, cartridges and sterile prefillable glass syringes. Today, 70% of the goods manufactured at the plant are for the Indian markets, whereas the rest are exported. The facility will now be able to increase its production capacity by 50%.With the Indian pharmaceutical market growing by approximately 14 to 17 percent per year, this expansion of packaging capabilities has been driven with respect to the by demand from India's prospering middle class. The primary shareholders of the company include veterans fo the Indian industry such as Mr.Shapoorji Pallonji Mistry, and Mr.Kairus Dadachandji, both of whom own 25% stake and the rest is owned by SCHOTT AG , Germany. In 2008, the international technology group SCHOTT and Kaisha Manufacturers formed the joint venture of SCHOTT KAISHA. Since its merger, SCHOTT KAISHA has garnered over 150 customers in the pharma space and have been growing at a steady rate of 25% YoY. The 50:50 joint venture today employs about 1,600 people in its plants in Daman and Jambusar and its Mumbai office. ]]> <![CDATA[Genomics to be blended with traditional knowledge: health minister ]]> https://biospectrumindia.com/news/95/1072/genomics-to-be-blended-with-traditional-knowledge-health-minister-.html https://biospectrumindia.com/news/95/1072/genomics-to-be-blended-with-traditional-knowledge-health-minister-.html Wed, 13 Feb 2013 11:18:00 +0530 The union minister of health, Ghulam Nabi Azad while addressing the inaugural programme of 'International Conference on Traditional Medicine for South East Asian Countries' in New Delhi on February 12, 2013 sounded very excited about the outcomes of mixing traditional and modern medicine. He said, "Modern advanced technologies like genomics are also being used to study the fundamental concepts of prakriti; i.e. body constitution described in ayurveda. AYUSH drugs are being studied with advanced techniques for their activity on immune systems in disease like HIV-AIDS, for anti-cancer activity and anti-diabetic activity. "In order to make research findings in AYUSH systems and allied faculties accessible through the web, the department of AYUSH has developed an 'AYUSH research portal' which can be accessed by everyone", he added Taking about the various research initiatives being taken by his ministry, Azad said, "The interdisciplinary research involving scientists of basic sciences, chemists, pharmacologists, biologists as well as engineers has also been encouraged in core areas of research in AYUSH systems. These include fundamental research comprising of interpretation and revalidation of basic principles of AYUSH systems; literature research covering revival, preservation, translation, critical analysis, systematization and publication of manuscripts; drug research including medical, ethnic and botanical surveys, cultivation of medicinal plants, standardization and quality control, preclinical safety, toxicity and biological activity screening and clinical research encompassing observation studies and phased clinical trials." "India has a pluralistic healthcare delivery system where the Government provides opportunity to every recognized medical system to develop and practice with a view to provide integrated and holistic healthcare services. It is open to patronizing best practices and proven standards for the benefit of the people", said the minister. Addressing the inaugural programme, Dr Samlee Plianbangchang, regional director general of world health organization (WHO) outlined the steps to be taken for promoting the traditional medicine in south east asia region (SEAR) countries. Dr Margaret Chan, director deneral of WHO, in her recorded message, highlighted the challenges of integrating the traditional medicine in Healthcare. Earlier Anil Kumar, secretary, department of AYUSH narrated the huge infrastructure of AYUSH developed by Government of India in the country and initiatives taken by the department in quality of AYUSH drugs and practices. ]]> <![CDATA[Indo-Bangla joint push for healthcare]]> https://biospectrumindia.com/news/95/3094/indo-bangla-joint-push-for-healthcare.html https://biospectrumindia.com/news/95/3094/indo-bangla-joint-push-for-healthcare.html Tue, 12 Feb 2013 16:51:00 +0530 While Mr Ghulam Nabi Azad, union minister of health and family welfare signed the agreement on behalf of government of India, Dr AFM Ruhal Haque, health minister signed on behalf of the government of Bangladesh. Through this MoU, the two nations will promote the joint research, exchange of scientific insights, manpower and mainly the joint health campaigns. The main areas of cooperation between the two governments will include: exchange of medical doctors, other health professionals and experts; development of human resources; exchange of information on health; medical and health research development; regulations of pharmaceuticals, medical devices and cosmetics; health promotion and disease prevention; fostering cooperation for the development of culturally sensitive and effective public and professional awareness campaign including clinical practices and best practices guidelines for healthcare providers and caretakers to benefit individuals and families touched by autism spectrum disorders and developmental disabilities; and others area of cooperation as may be mutually decided upon. Further, the parties shall promote cooperation between the two countries in the fields of health and medical sciences through the following: Exchange of scientific materials and information Joint collaboration in the area of research in medical science Institution level cooperation in the field of medical treatment, scientific research and training Exchange of health specialists and professionals Participation of specialists/professionals in seminars, workshops, conferences and meetings to be organized by both the parties Training for doctors and health workers by both the parties in the areas where they have relevant expertise and excellence. ]]> <![CDATA[Agribiotech to herald India's second green revolution]]> https://biospectrumindia.com/news/95/3098/agribiotech-to-herald-indias-second-green-revolution.html https://biospectrumindia.com/news/95/3098/agribiotech-to-herald-indias-second-green-revolution.html Tue, 12 Feb 2013 15:50:30 +0530 "Dreaded diseases like small pox and polio have been eradicated because of the technology. Somehow technologies in other areas are at a rapid speed like nano, pharma, and nuclear. There is a need for biotechnology to intervene into agriculture in a big way. Without technology we cannot increase our agricultural productivity," said Mr P Chengal Reddy, secretary general, Consortium of Indian Farmers Associations. Speaking at a session on "Agribiotechnology to herald India's second green revolution" at Bangalore India Bio 2013, Mr Reddy said, "In India, crops are lost through flood, pest and insects. In the last 25-35 years, conventional biotech research have emerged. About 29 countries around the world like America, Brazil, Australia, and Canada are using genetically modified crops. About 97 percent of food in the US is genetically made and there have been no signs of any medical adverse effects in humans and animals. Our aim is that, in two years India should be the number one producer of Bt Cotton. However, biotech is not supported well in India and in the last three years no notable research has come up." "Agribiotech is the need of the hour. There is a need to increase the productivity which can be done by using biotechnology. Without technology, we farmers are dead, said Mr Chengal Reddy, who coined groundnut as "Golden Nuggets", cotton as "Golden Fibre" and maize as "Golden Seed" and adding that, "Biotechnology is the golden technology." Sharing his thoughts, Prof. M Mahadevappa, former vice chancellor, University of Agricultural Sciences, Dharwad, said, "India has the second largest "arable land" in the world after USA. India has diverse agro-climatic conditions. About 65 percent of rural population depends on agriculture as the main source of livelihood. Nevertheless, India has improved its food productivity from 522kg/hectare (1945-65) to 944kg/hectare (1956-75) and is now being called as "food sufficient" from "food deficient." He further said, "The government has approved 17 GM crops of eight traits, which are virus resistant and bacteria resistant as in 2012. India is facing challenges such as increasing human population, decreasing soil fertility, and yield loss due to biotic stress. India is now exporting Bt cotton; there was a time when Bt cotton was imported to India. Golden rice, which is rich in Î²-carotene, offers a great solution for India as nearly 5000 children go blind every year because of Î²-carotene deficiency. Biotechnology offers great opportunities in agriculture in terms of value addition of food crops." Dr KK Narayanan, managing director, Metahelix Life Sciences said, "To accept any technology like the biotech, the data is very important and has to be analyzed extensively. In India the first biotech crop which was commercialised is the Btcotton and today about 93 percent of farmers are growing Bt cotton. Bt cotton has tangible benefits like protection from worms and increased productivity. About 30,000 hectares of area was covered under Bt cotton in India in 2005 and 9.5 million hectares in 2008, which is a significant improvement and by the next 2-3 years India will be largest producer of cotton in the world. The average increase in production is about 1.2 percent and the increase in population is 1.8 percent annually. To increase the productivity we need the infusion of technology to achieve second green revolution and about 10 percent increase is needed every year in productivity to meet the growing demands of the population in 2030." ]]> <![CDATA[Panacea Biotec to develop township?]]> https://biospectrumindia.com/news/95/3089/panacea-biotec-to-develop-township.html https://biospectrumindia.com/news/95/3089/panacea-biotec-to-develop-township.html Tue, 12 Feb 2013 11:52:00 +0530 Panacea Biotec has been trying to find avenues to make up for its loss in revenues in the last fiscal. The company, in past one year, through its subsidiary, NewRise Healthcare, initiated the development of a 225-bed multi super-specialty hospital in Gurgaon, Haryana, with an investment of around Rs 140 core. The hospital is set to commence operations by the end of current fiscal year. Now, again in a move that is being seen as a major shift from its core business, the company has tied up with the Gurgaon-based real estate firm Bestech Builders to develop a huge plot of land national capital area (NCR). The land in Gurgaon where the township has been planned was held by Best On Health (BOH), Panacea's wholly owned subsidiary. Bestech Builders and along with Panacea it will hold an equal stake in the project, expected to generate revenues of over Rs 1,500 crore. Panacea, as per Economic Times (ET) initially planned to develop a biotech special economic zone (SEZ) on this property. The company has not issued any comment or any clarification in this regard. The Economic Times report quoted Mr Sunil Satija, managing director of Bestech Group saying that his company has signed a memorandum of understanding, but the final agreement will be signed by the end of February. "We will build a residential colony on the plot. Around 75 percent of the project will comprise villas and residential units, while the remaining will be sold as plotted development," said Mr Satija. The move comes at a time when Panacea is under pressure to put a halt to its losses that have continued to mount in the current financial year with reported net loss of Rs 62.28 crore during the third quarter ended December 2012. ]]> <![CDATA[Indian Vaccine sector: opportunities and challenges]]> https://biospectrumindia.com/features/95/4783/indian-vaccine-sector-opportunities-and-challenges.html https://biospectrumindia.com/features/95/4783/indian-vaccine-sector-opportunities-and-challenges.html Tue, 12 Feb 2013 11:44:00 +0530 Recently, Panacea Biotec, India' s second largest producer of vaccines, bagged an order worth Rs 187.61 crore from the Indian government for the supply of 345 million doses of trivalent oral polio vaccine (tOPV) and bivalent oral polio vaccine (bOPV). The same has to be supplied between December 2012 and May 2013. The order is to meet the requirements of national immunization days (NIDs) and supplementary national immunization days (SNIDs). The deals are an indication that the Indian government has stepped up its dependency on the Indian companies. The policymakers in fact have always been worried about the lack of vaccination alternatives and the high prices from the multinationals. Yet, the vaccine market at two percent penetration as McKinsey report puts it, is significantly under-penetrated. It estimates the Indian vaccine market at around $900 million and it is poised to grow to $4.6-billion revenue by 2017. With the opportunities wide open, the vaccine manufacturers are aiming to consolidate their positions. Local companies play epochal role The model that most Indian vaccine makers follow is similar to what domestic generic drug companies have been doing for a long time. Indian vaccines, alike the Indian generic medicines are also being projected as low-cost alternatives to high-priced vaccines produced by global majors. Every year, the rotavirus causes fatal diarrhoea that kills around 500,000 children under five years. Among the key companies, the vaccines that are currently undergoing phase III clinical trials for safety and efficacy in 8,000 children and, along with vaccines from Serum Institute of India and Shantha Biotechnics, are expected to hit the market in 2015. These vaccines will bring the price of vaccinating a child to $3, down from the current $7.5 per dose. Bharat Biotech had announced that it will price rotavac, India's first indigenously developed rotavirus vaccine at $1 per dose. According to Dr Krishna Ella, chairman of Bharat Biotech, "When this company had initiated the development of Rotavac a decade ago, a promise was made that the vaccine, as and when approved, will be priced below $1 a dose for global supplies." Dr Ella feels that the competition will always be helpful in reducing the prices further. Serum Institute of India, one of the country's leading vaccine producers, claims that two of every three children immunized in the world is vaccinated by a vaccine, which is manufactured by the company. The company's products, used in 140 countries, are known for their low cost. Last year, Serum Institute lowered the price of its pentavalent vaccine to $1.75 per dose, the lowest price available globally. Panacea Biotec has committed to lower its prices of vaccines by up to 15 percent. The company introduced EnivacHB (hepatitis B) in 1997. The superior manufacturing process lead to better immunogenicity proven in clinical trials. The unique prefilled syringe ready-to-use device (ENivac HB Safety) ensured safe injection practices advocated by World Health Organization (WHO). The EasyFive (pentavalent vaccine - DTP-HIB-HepB) was introduced by the company in 2005. The first fully liquid (wP) pentavalent vaccine was introduced in 2007. Dr Rajesh Jain, joint managing director, Panacea Biotec, says, "We have utilized the unique Easy-Track mobile sms service to remind the parents for timely immunization of the child and also Easy-Vaccination mobile and web-based service to educate the customers about vaccination online." Major hurdles faced by vaccine industry Technological capacity and access to know-how Lack of generic pathway for vaccines High capital investment in manufacturing infrastructure with lack of demand Gap in the need and accessibility of vaccines Need to add new vaccines in Expanded Program on Immunization (EPI) High cost of R&D, long and complex clinical trials result in longer time to licensure Entry barriers to emerging suppliers in competition Many believe that companies might not be able to offer affordable vaccines owing to high investments in R&D, the dual pricing might be one of the solutions. "I suggest dual pricing policy and control over price when government is buying it. For people, who can afford it, can take them," says Dr Shirshendu Mukherjee, senior strategic advisor, Wellcome Trust. At present, HPV vaccine is priced between Rs 6,000 to Rs 7,000 per dosage. Shortly one can see the companies putting efforts to develop HPV vaccines by Indian companies. The growing involvement of the Indian companies is also forcing the global players to come up with a local strategy. In fact, the affordable vaccines from India is forcing the big multinationals to go for reduction in prices. For example, the prices of basic pediatric vaccines have been reduced significantly over the years to match the budgetary constraints. Earlier, the recombinant vaccines against hepatitis B by GlaxoSmithKline (GSK) and Merck were the first to be sold in India at $40 a dose. After patent expiry of the innovator vaccine, and with the entry of low-cost manufacturers, prices were reduced to $1 per dose. For the pentavalent vaccine (DTP-HepB-Hib), the prices offered to the United Nations Children's Fund (UNICEF) and the Pan American Health Organization (PAHO) were dropped by 50 percent during last five years from approximately $4 per dose. GSK has announced its rotavirus vaccines at $2.50 per dose or $5 to fully immunize a child in response to a current tender administered by UNICEF. The offer is a 67 percent reduction in the current lowest available public price. Merck also announced reducing HPV vaccine prices from the current $15 per dose to $5 per dose, a 67 percent reduction in the current public price. The decision came after Serum Institute of India and Panacea Biotec lowered the prices of their pentavalent vaccine that protects against five potentially fatal infections such as Hib (Haemophilus influenzae type b), diphtheria, pertussis (whopping cough), tetanus, hepatitis B, rotavirus and cervical cancer. The report by Global Health Strategies Initiatives (GHSI), an international non-profit organization working to improve health in developing countries, puts India as the largest producer of low-cost drugs and vaccines. With India producing 60 percent of the world's vaccines and accounting for 60-80 percent of the annual United Nations vaccine purchases, several Indian vaccine manufacturers have been granted the WHO prequalifications approval for quality. To make vaccines available in developing world countries, immunization programs are driven and funded by governments and UN agencies like WHO, the Global Alliance for Vaccines and Immunization (GAVI Alliance), Pan American Health Organization (PAHO), PATH with funding from donors like Department for International Development (DFID, UK), Japan International Cooperation Agency (JICA, Japan), Rotary Foundation, Rock Feller Foundation, and Bill and Mellinda Gates Foundation. Talking about the government role, Dr TS Rao, senior advisor, Department of Biotechnology (DBT) opined, "National immunization program of the government is the best example of policy makers regulating the prices directly, so that the vaccines should reach the masses at affordable cost. Government has to look at various options to make the vaccines affordable. For example, the polio vaccine was made available to masses at negligible price through the public programs. Without compromising the quality of vaccines, we have to work towards achieving the affordability. Healthy competition is a necessity for the companies and at the same time the government too has social responsibility." Dr Mukherjee, agreeing with Dr Rao, feels that Indian funding agencies are big pillars who have played a vital supportive role. "The Hep B vaccine is now available at approximately Rs 15 per dosage while outside of India its price is about Rs 70 per dosage. Earlier, a MNC used to sell it at Rs 400 per dosage. But after Technology Development Board (TDB) funded Shantha Biotechnics' vaccine program, the price came down substantially. Then other companies such as Panacea Biotec, Wokhardt, Bharat Biotech and Serum Institute of India too launched their products at affordable price. This describes the success story of how India had funding agencies as big pillars in developing vaccines," explained Dr Mukherjee. Although WHO estimates that the basic immunization coverage has improved substantially in recent decades (from about 20 percent in 1980 to about 80 percent in 2007), there are about 26 million children (roughly 1 in 5 born per year), who still needs to be immunized. Wider use of available vaccines could further avoid about two million deaths annually. The new vaccines need to be added to the immunization schedule, but these are prohibitively expensive. Vaccines like rotavirus, pneumococcal, meningococcal, and HPV are already available in developed world but still out of reach in the developing countries. Since both governments and United Nations agencies have limited funds, there is always a pressure on decreasing the price of vaccines to improve the access. It is being hoped that the emergence of new-generation vaccines will see India's vaccine market transition from being a publicly-funded initiative to a private business, where vaccines will be prescribed by private practitioners across the country. ]]> <![CDATA[Delhi to host conference on traditional medicine ]]> https://biospectrumindia.com/news/95/3032/delhi-to-host-conference-on-traditional-medicine-.html https://biospectrumindia.com/news/95/3032/delhi-to-host-conference-on-traditional-medicine-.html Mon, 11 Feb 2013 14:46:00 +0530 The International Conference on Traditional Medicine, which is to be attended by health ministers of the SEARO (South East Asia Region), WPR (Western Pacific Region), experts from WHO, and other countries, is expected to broaden and update the knowledge on integration, regulation and research priorities in traditional and complementary medicine. The conference is being held at New Delhi from February 12-14, 2013. It will also enhance cooperation among SEARO countries in the field of traditional medicine. The event is in accordance with the 62nd World Health Assembly Resolution in 2009 that urged the member states to undertake various activities in the field of traditional medicine. In recent years there has been global upsurge in the use of traditional medicine because of its availability, accessibility and affordability as against the modern healthcare services which are beyond the reach of people. It may be mentioned that traditional medicines are used around the world including South-East Asian countries for healthcare by the people. The countries have a rich heritage of several systems of traditional medicine and have vast resources of medicinal plants and huge repositories of knowledge. The objective is to promote the role of traditional and complementary medicine in healthcare provision, their use in primary healthcare, share research methodologies for studies on safety, efficacy and quality in order to identify best practices to ensure the safety, share national policies, programs and experiences to promote and propagate in SEARO Region. It also aims to exchange views and share evidence-based information and country experiences on traditional medicine and complementary medicine, identify priority issues and challenges in strengthening the development and appropriate integration of traditional medicine as part of the national health system. India has long history and culture running over 5000 years of using traditional medicines for healthcare. Indian traditional systems of medicines viz. ayurveda, yoga, naturopathy, siddha, and sowa-rigpa are comprehensive scientific systems of medicine evolved in India. Over a period of time, India has developed vast network of infrastructure for its traditional system of medicine and homoeopathy including five research councils (one for each system), National Institute for each system, National Medicinal Plants Board (NMPB), two statutory regulatory bodies [Central Council of Indian Medicine (CCIM) and Central Council of Homoeopathy (CCH)], and two apex laboratories [Pharmacopoeial Laboratory for Indian Medicine (PLIM) and Homoeopathic Pharmacopoeial Laboratory (HPL]. ]]> <![CDATA[Sun Pharma and Taro terminate transaction deal]]> https://biospectrumindia.com/news/95/3071/sun-pharma-and-taro-terminate-transaction-deal.html https://biospectrumindia.com/news/95/3071/sun-pharma-and-taro-terminate-transaction-deal.html Mon, 11 Feb 2013 13:31:21 +0530 Sun Pharmaceutical Industries (together with its subsidiaries, "Sun Pharma") and Taro Pharmaceutical Industries have announced that they have mutually agreed to terminate their merger agreement, announced in August 2012, pursuant to which all shareholders of Taro (other than Sun Pharma and its affiliates) would have received a cash payment of $39.50 per share upon the closing of the merger. Each of Sun Pharma and Taro (at the direction of the Special Committee) agreed that terminating the merger agreement was in the best interest of the respective companies and shareholders. Sun Pharma's consolidated net profit jumped 31.9 percent to Rs 881.30 crore on 33 percent growth in net sales to Rs 2852.01 crore in Q3 December 2012 over Q3 December 2011. Sun Pharmaceutical Industries is an international, integrated, specialty pharmaceutical company. It manufactures and markets a large basket of pharmaceutical formulations as branded generics as well as generics in India, the United States and several other markets across the world. ]]> <![CDATA[Stem cells to become benchmark for medical treatment]]> https://biospectrumindia.com/news/95/7651/stem-cells-to-become-benchmark-for-medical-treatment.html https://biospectrumindia.com/news/95/7651/stem-cells-to-become-benchmark-for-medical-treatment.html Fri, 08 Feb 2013 17:32:31 +0530 "Today, regenerative medicine, stem cells, neurology have tremendous potential. Stem cells will become a major benchmark for medical treatment. They can be utilized in many ways," said Mr BN Manohar, chief executive officer, Stempeutics Research. Chairing a session at Bangalore India BIO 2013, he said, "BioPharma can change the present $5 billion to $100 billion by 2025. Globally $150 billion revenue is made by biotechnology industries in which 15 percent is from pharma industries, and India contributes 10 percent to pharma revenue." Sharing his views on use of stem cells, Dr NK Venkataramana, director of Advanced Neuro-Science Institute and vice chairman of BGS-Global Hospitals said, "Stem cells can become a boon for people with neurological disorders. In India more than 15 million people are suffering from neurological disorders every year. In the past 30 years, I have never seen a recovery of spinal cord injury, but now the stem cells are giving hope that recovery is possible." He further said, "Different sources of stem cells give different genetic expressions and can be used for different purpose. All stem cells are not equal. Most of the researchers use adult stem cells, embryonic stem cells for the research. Use of mesenchymal stem cells, a multipotent, hypo neurogenic in large scale production is possible. Bone marrow transplantation was known because of stem cells. With the advancement, we can distinguish the cells and utilize them for the purpose." Sharing the research initiatives taking place at his laboratory, Prof. Ravi Bellamkonda, associate vice president for research, Carol Ann and David D Flanagan Chair in Biomedical Engineering and GCC distinguished scholar, Georgia Institute of Technology, USA, said ,"The concept of damaged cells to regenerate the cells in the nerve gap, the polymer drug for the cell therapy to grow organ, which is to be viable but needs investments. When the nerve gaps are more than 10mm they don't heal fast on their own, surgeons use pseudo nerve for nerve grafting. Nerve grafting has many disadvantages like second surgery. The multiple grafting has 40 percent success rate. We are working in our lab to design a pseudo nerve, which has genetic approach and has the capacity for bridging for auto grafting and also developing a gel. This was developed directly in the tissues but it did not work. So we tried to work with the embryonic cells (rat), fiber cells with polymer, which allows the gel formation and subsequently allows the nerve growth. The study is still under process." ]]> <![CDATA[Sun Pharma reports 32% surge in Q3 net profit]]> https://biospectrumindia.com/news/95/7992/sun-pharma-reports-32-surge-in-q3-net-profit.html https://biospectrumindia.com/news/95/7992/sun-pharma-reports-32-surge-in-q3-net-profit.html Fri, 08 Feb 2013 16:12:08 +0530 Sun Pharmaceutical Industries has reported financials for the third quarter ending December 31, 2012. The pharma major's third quarter net sales rose 32 percent from a year ago to Rs 2,852 crore. Performance Highlights: Net profit was at Rs 881 crore which witnessed a growth of 32 percent over Q3 last year. Branded generic sales in India was at Rs 788 crore, up by 13 percent over Q3 last year. US finished dosage sales was up by 32 percent at $276 million The international formulation sales at $73 million grew by 31 percent over same quarter last year. EBITDA was reported at Rs1261 crore seeing a 31 percent growth compared to Q3 last year. The company's Israel-based subsidiary Taro Pharmaceutical recently reported a 42 percent rise in third quarter net profit at $89 million, while net sales gained 25 percent to $186 million. Mr Dilip Shanghvi, managing director, Sun Pharmaceutical Industries said, "All our businesses continue to perform in-line with our expectations. The recent approval of our generic Doxorubicin HCl Liposomal Injection in the US reflects our technological strengths in developing complex products. The acquisition of DUSA and URL's generic business will further strengthen our presence in the US. Overall, we shall strive to remain focused on execution and building a business with consistent performance." ]]> <![CDATA[Industry welcomes anti-GM activist Lynas turnaround ]]> https://biospectrumindia.com/news/95/8245/industry-welcomes-anti-gm-activist-lynas-turnaround-.html https://biospectrumindia.com/news/95/8245/industry-welcomes-anti-gm-activist-lynas-turnaround-.html Fri, 08 Feb 2013 12:44:07 +0530 "So my message to the anti-GM lobby, from the ranks of the British aristocrats and celebrity chefs to the US foodies to the peasant groups is this. You are entitled to your views. But you must know by now that they are not supported by science. We are coming to a crunch point, and for the sake of both people and the planet, now is the time for you to get out of the way and let the rest of us get on with feeding the world sustainably," spoke the celebrated anti-GM activist, Mark Lynas at an Oxford University conference in January, reversing his opposition to GM crops.In more than a month, the anti and pro-GM groups have been discussing the turnaround which has stunned the world. " His support from being a staunch opponent of GM crops is a morale booster," said a bioagri company representative during the Bangalore India Bio conference on February 5 in Bangalore. Leading biotechnologist Kiran Mazumdar-Shaw came out openly in favour of GM crops at the conference. She in fact said the anti-science policy that banned Bt brinjal, approved by the regulator, is a dampener. Mazumdar-Shaw if the government allows GM technologies to flourish, this segment alone could contribute a fourth of the $100 billion revenue target the industry has set for itself for the year 2025 from the current year's $ 5 billion. She highlighted the fact that India has become a net exporter of cotton, thanks to the introduction of Bt cotton within a decade. And the value of Bt cotton last year was close to $ 4 billion. Lynas, the author of The God Species: How the Planet Can Survive the Age of Humans, published in July 2011, has been a major supporter of Greenpeace, the NGO staunchly opposed to genetically modified(GM) crops and has participated in several high profile anti-GM campaigns. "I am sorry that I helped to start the anti-GM movement back in the mid-1990s and that I thereby assisted in demonising an important technological option which can be used to benefit the environment," Lynas said in his Oxford lecture. " I had assumed that GM was dangerous. It turned out that it was safer and more precise than conventional breeding using mutagenesis for example; GM just moves a couple genes, whereas conventional breeding mucks about with the entire genome in a trial and error way." BioAgri companies have got a boost from the turnaround by one of its most vocal opponents and are planning to launch campaigns to create public opinion favourable to GM technologies.The full text of Mark Lynas' speech can be accessed at http://www.marklynas.org/2013/01/lecture-to-oxford-farming-conference-3-January-2013/ ]]> <![CDATA[Indo-Japan bio partnerships on rise]]> https://biospectrumindia.com/features/95/3064/indo-japan-bio-partnerships-on-rise.html https://biospectrumindia.com/features/95/3064/indo-japan-bio-partnerships-on-rise.html Thu, 07 Feb 2013 17:42:10 +0530 Beaming with confidence at his company's march into the Japanese market, Dr Rashmi Barbhaiya CEO, Advinus Therapeutics was quite hopeful that the partnership with Takeda Pharmaceuticals will have a great future. "Takeda and Advinus teams will together advance globally in networked innovation for addressing key pharma R&D productivity and issues for better returns on R&D investments," he had added when this exclusive three-year discovery deal was signed in October 2012. While Takeda will receive worldwide commercial rights to the drug candidates emerging from this alliance, Advinus will receive $36 million worth guaranteed research funding, $9 million in milestones leading to candidate selection, and is also eligible to receive future clinical and regulatory milestone payments of up to $45 million per product, plus royalties on product sales worldwide. Such a deal surely has made many others in the industry to realize that Japanese manufacturers can offer great opportunities. In yet another example of the growing proximity between two bioscience industries, Dr Reddy's Laboratories (DRL) had formed a joint venture with Fujifilm in June 2012, to develop, manufacture and promote generic drugs in Japan. The venture has 51 percent stake owned by Fujifilm and 49 percent by Dr Reddy's, and intends to launch its first products in Japan in the next three to four years. Dr Reddy's will develop, manufacture and promote competitive and high quality generic drugs utilizing both Fujifilm's advanced quality control technologies and DRL's expertise in cost competitive production technologies for active pharmaceutical ingredients and formulations. In fact, the mutual bioscience relationship between the two nations has come a long way since the establishment of the first ever Indo-Japanese joint venture firm, Sanzyme (earlier known as Uni-Sankyo) in 1969. Headquartered in Hyderabad, the company expanded its activities and evolved as the manufacturer of fermentation and biotechnology products in the country. Driving on generics The complex regulatory framework in Japan creates a high entry barrier and hence the likely route to gain presence is through partnerships with local generic companies or acquisitions of local companies. Using the same model, the Indian generic players such as Lupin, Ranbaxy and Cadila Healthcare have made inroads with the Japanese market. The Japan-based Kyowa Pharmaceutical was acquired by Lupin in 2007, leading to the latter's access to the Japanese market. The company has made an investment of $63 million in the area of generics in Kyowa. Cadila Healthcare too has presence in the Japanese market since 2007 after it acquired Nippon Universal Pharma. The company is pinning big hopes on the Japanese generics market. The country, which currently has a one percent share in Cadila's overall revenues, is all set to become a key market in the coming years. It already has around 20 products in the Japanese market including three recent launches. One of the major example of Japanese pharmaceutical companies entering India, is the acquisition of Ranbaxy Pharmaceuticals by Daiichi Sankyo in 2008 and the establishment of a R&D centre and facility by Eisai Pharmaceuticals. At the beginning of 2010, Eisai, the fourth largest Japanese pharmaceutical company, started operations in India; by setting up an API plant and knowledge center at an investment of $50 million. Meanwhile, Ranbaxy is exploring opportunities of marketing its generic products through Daiichi's distribution network post its acquisition by the latter. Astellas, the second largest pharmaceutical company in Japan, too has opened its subsidiary and marketing operations in India four years back. As against an estimated global 6-7 percent generic drugs market penetration in 2007, the Japanese government has implemented various measures to promote the use of generic drugs to achieve its goal of reaching 30 percent volume share for generic drugs by the end of march 2013. The market thus offers new growth avenue for Indian generic players. Attracting biosuppliers Besides pharmaceuticals industry, the biosupplier industry too has not lagged behind in its zeal for collaborative efforts. A well known Japanese supplier, Shimadzu, has set up its direct presence in India in 2006 by establishing Shimadzu Analytical India, as a subsidiary of Shimadzu Asia Pacific, Singapore. The company has tied up with many Indian distributors to supply its broad range of analytical products mainly chromatography and measurement instruments. The recent example in this vertical is that of a joint venture "DSS Takara Bio India" established between India-based DSS Imagetech and Japanese company Takara Bio, that came into effect in April 2011. With the capital investment of $1 million and 25 employees, the DSS Takara Bio India has been engaged in the manufacturing and sales of research reagents and kits. Dr Ushakar Nag, director, DSS Takara Bio believes that they are bringing to India world-class Japanese manufacturing technology of high-end molecular biology reagents thereby giving a competitive edge to Indian biological research. Another Japan-based leading manufacturer of automated nucleic acid extraction systems and supplies, PSS Bio, recently had a technical collaboration with Mumbai-based Biotron Healthcare. The partnership will produce magnetic-based nucleic acid extraction kits, which is expected to reduce the cost of extraction. Mr Hideji Tajima, president, PSS Bio, Japan in an earlier interview with BioSpectrum reiterated that the company is hoping to start the evaluation of fully-automated genetic diagnostics systems in India. Growing research relationship Chennai-based Indo-Japanese joint venture, Nichi-In Centre for Regenerative Medicine (NCRM), has in the past 10 years brought together the Indian and Japanese technologies and institutes to accomplish several significant contributions in the field of regenerative medicine/biotechnology. The autologous immune enhancement therapy, which has been in clinical practice in Japan, since 1990s has been brought to India by the NCRM. Dr Samuel JK Abraham, director, NCRM says, "To my knowledge, the natural killer (NK) cell and cytotoxic T lymphocytes (CTL) based immunotherapy has been provided only by NCRM in India, since 2011 and this was accomplished by the technology fetched from Japan and also the constant interaction of personnel between the two countries. Japan has the advantages of several state-of-the-art technologies in lab chemicals, reagents including cell culture scaffolds and nanomaterials. In India, we have young talents and wide spectrum of clinical diseases which are rare in the West and in Japan and so both the countries will benefit by a collaboration as accomplished by NCRM." Among the recent examples, the collaboration between Waseda University and GN Corporation, both from Japan and Sankara Nethralaya and NCRM in India, has led to the development of the polymer-based in vitro cell expansion technology for multiplication of corneal limbal stem cells and further animal studies have been already completed and clinical studies are to be conducted soon. The invention was awarded a patent last year. Apart from that, encouraging results have been achieved from the joint efforts of Hokkaido University and Waseda University in Japan and Tamil Nadu Veterinary and Animal Sciences University (TANUVAS) and NCRM in India. These research partners have developed a scaffold for spinal cord injury, which can retain the implanted autologous stem cells into the site of the injury. This technology has been tried in animal victims of spinal injury and safety studies has been proven with a publication. Enhancing bonding efforts The Japanese government has expressed willingness to invest in all sectors of the Indian economy including the biotechnology, nanotechnology, and life sciences projects. Economically, further consolidating the comprehensive economic partnership agreement (CEPA) signed in August 2011, India and Japan will be cooperating on the life sciences sector in a major way. It should be noted that the government of Japan, in 2010, has extended a grant of 120 million yen (approximately equivalent to Rs 7.2 crore) under the United Nations Children's Fund (UNICEF) for maintaining a polio free India project to eradicate poliomyelitis from India. India Japan Science Council, working for the last 14 years, has so far been a very effective vehicle of science and technology cooperation between the two countries. The India-Japan Joint Committee (IJJC) has been the nodal agency to implement the science and technology agreement signed in November 1985. It looks into major policy issues, reviews the progress and proposes measures for enhancing the cooperation. While from Indian side, it is coordinated by Department of Science and Technology (DST) with members from Council for Scientific and Industrial Research (CSIR), Indian Council for Medical Research (ICMR), Department of Biotechnology (DBT) and other scientific departments of India, the Japanese side is represented by its ministry of foreign affairs with members from education, science, health, industry and other relevant ministries. With a view to represent the demands of the Indian pharma companies in Japan, the Pharmaceutical Export Promotion Council of India (Pharmexcil), set up by ministry of commerce and and industry, constituted an indigenous body called India-Japan Pharma Alliance in Japan last year. This body will be acting as the Pharmexcil's frontal agency to represent the issues and the challenges faced by the Indian pharmaceutical companies in Japan. The Confederation of Indian Industries (CII) report 2012 titled "India-Japan: A Growing Strategic Relationship" has predicted that the two countries would achieve a trade target of $25 billion by 2014. Strong mutual complementarities between two nations are driving the trade and potential sectors of trade and investment including capital goods, auto parts, chemicals and pharmaceuticals among a wide range. It is very important for both the nations to encourage bioscience cooperation and lay down a concrete road map for the future. ]]> <![CDATA[Krishidhan's Bt cotton hybrid sets new record]]> https://biospectrumindia.com/news/95/3068/krishidhans-bt-cotton-hybrid-sets-new-record.html https://biospectrumindia.com/news/95/3068/krishidhans-bt-cotton-hybrid-sets-new-record.html Thu, 07 Feb 2013 12:53:00 +0530 Pratik BGII cotton seed is one of the leading cotton seed developed by Krishidhan Seeds, a company that combines conventional breeding approach with the state-of-the art technologies to deliver value added quality products that ensure higher yields to farmers. Pratik BGII cotton has set yet another record of cultivating highest weighing cotton boll in Vidarbha region. The seed already known for its good cotton yield production, yielded 6 gram of cotton against an average of 4 gram in the region. This was achieved by Mr Wasim Khan, a farmer from Barshitakali, Akola region, who cultivated highest weighing cotton bolls in his 2 acre of farm field. Mr Khan has received cotton output of 50 quintals. India is one of the largest cotton growing countries in terms of area i.e. 116 lakh hectare. Though India ranks second in production after China with around 334 lakh bales, it's per acre lint yield of 489 kg per hectare compares very low against the world average of 775 kg per hectare. Explaining his success Mr Wasim Khan said that, "Pratik BGII cotton seed is tolerant towards all major sucking pests, bollworm (Helicoverpa) and armyworm (Spodoptera). These insect pests cause great damage to cotton crop and has been responsible for its low productivity in the past. In our region, farmers get on an average 12-18 quintals of cotton production from an acre under irrigation. However, with the use of Pratik BGII cotton seed, proper water management and continuous guidance from Krishidhan seeds' experts, a remarkable increase in cotton production is achieved." Mr Sushil Karwa, managing director, Krishidhan Group of Companies commented that, "Cotton variety Pratik BGII has been developed, after an extensive research by our scientists, to give high yield of cotton in the major cotton growing areas in the country. Pratik BGII is the result of superior genetic breeding by our scientists which is highly tolerant to all the major pests and grows very well in both rain fed and irrigated regions, giving record production. We are extremely encouraged to see the results of our superior quality seed and feel proud that we can contribute towards making our farmers financially stable through, successive high yields." ]]> <![CDATA[YK Hamied to step down as Cipla MD ]]> https://biospectrumindia.com/news/95/3065/yk-hamied-to-step-down-as-cipla-md-.html https://biospectrumindia.com/news/95/3065/yk-hamied-to-step-down-as-cipla-md-.html Thu, 07 Feb 2013 11:38:00 +0530 Dr YK Hamied, 77, a leading scientist and chairman and MD of Cipla, which is India's second largest healthcare company, is stepping down as the MD of the company. According to a company statement, he has expressed his desire to retire as the managing director. Dr Hamied, however will continue to be the chairman of Cipla in a non-executive role effective April 01, 2013. Dr YK Hamied had taken over the reins of Cipla (established in 1935) when his father Mr Khwaja Abdul Hamied died in 1972. "The board unanimously acknowledges the outstanding contribution of Dr Hamied to the company over the past 52 years, and in deference to his wishes, has accepted his proposal to retire as managing director effective March 31, 2013," said the statement. Dr Hamied has been enormously influential in pioneering development of multi-drug combination pills notably for HIV/AIDS, TB, asthma and other ailments chiefly affecting developing countries, as well as the development of pediatric formulations of drugs, especially those benefiting children in poor settings. He is also highly regarded for his leading role in expanding the production of bulk drugs and active pharmaceutical ingredients (APIs) in India. He was awarded the Padma Bhushan by the Government of India in 2005. In 2011, he recieved the Lifetime Achievement Award from BioSpectrumAsia. More recently, Dr Hamied was awarded the 'Indian Of The Year' in the category of business by CNN-IBN in 2012. Cipla is currently in restructuring mode, which is slowly shifting from the family-run business to appointing professionals and experts. It recently appointed Mr Subhanu Saxena as its chief executive officer. ]]> <![CDATA[E-courses introduced in dairy technology ]]> https://biospectrumindia.com/news/95/3061/e-courses-introduced-in-dairy-technology-.html https://biospectrumindia.com/news/95/3061/e-courses-introduced-in-dairy-technology-.html Wed, 06 Feb 2013 16:39:00 +0530 A one-day program "Sensitization Workshop on Implementation of E-courses for BTech (Dairy Technology) Degree Program" was inaugurated at the National Dairy Research Institute (NDRI) on January 31, 2013 under the "National Agricultural Innovation Project" of Indian Council for Agricultural Research (ICAR), New Delhi. The implementation of the E-courses and handling of the users' feed-back towards up-gradation of the course contents regularly, was the major focus of the workshop. Dr AK Srivastava, director, NDRI and chief guest of the function formally inaugurated the workshop and also released the E-courses online. He emphasized that the syllabus of the courses should be constantly revised looking at the need of the society and the industry. In addition, he distributed the certificates to the teachers, who were involved in E-course development and praised their efforts for developing the contents in an excellent manner. Dr VK Gupta, principal scientist, Dairy Technology, presented the welcome address and informed about the importance of E-courses for students in the present context. Dr AA Patel, head, Dairy Technology said that the E-courses developed should not be taken as an alternative to classroom teaching, but these will assist in the learning process of the students. He greatly complemented the teachers who completed the assignment in time. On this occasion, senior academic staff from all Dairy Technology colleges of India participated in the deliberations of the workshop, so as to effectively implement these online courses at their own institutions. ]]> <![CDATA[India must shift from biosimilars to biobetters]]> https://biospectrumindia.com/news/95/3036/india-must-shift-from-biosimilars-to-biobetters.html https://biospectrumindia.com/news/95/3036/india-must-shift-from-biosimilars-to-biobetters.html Wed, 06 Feb 2013 11:56:44 +0530 India should now focus on biobetters and take the route of Europe to reach the US biosimilars market, said the speakers at a special session on "Biosimilar Guidelines for Development of Safe, Affordable and Efficacious biosimilars For The World" chaired by one of the main authors of India's Biosimilars Guidelines, Dr VP Kamboj, chairman, Biotech Consortium India Limited and former director, Central Drug Research Institute (CDRI), during Bangalore India Bio 2013 (BIB 2013). The session moderated by Dr VP Kamboj comprised of Dr PM Murali, president, ABLE and managing director, Evolva Biotech; Dr Abhijit Barve, president, research and development, Biocon; Dr William Lee, head, regulatory strategy, strategic drug development, Asia Quintiles, Singapore; and Dr Subir Kumar Basak, president, Global Drug Discovery Services, Jubilant Life Sciences. Dr VP Kamboj said, "Biosimilar guidelines in India was drafted in five intensive sessions by the regulators and academia along with the participation of companies and pater lawyers so as to make India as competitive as possible in the world. India has found a definite place in generics and is one of the leading nations to take generics to the global market particularly the US, Europe and Japan. Every company wants to reach the US and Japan markets as 40 percent of the world's total drug is consumed in the US and 19 percent in Japan, whereas only 14 percent of the total drugs are consumed by Africa, India and Asia together. There is 23-25 percent growth in Indian biopharmaceuticals and generics, which is the highest in the world. In 2011, US saved $192 million by using generics than other drugs. US is the goal for every biopharmaceutical company because of its major market." According to Dr Murali there is a tremendous opportunity in biosimilars. "India can become the capital of biosimilars by capturing 25 percent share of the $3.4 billion market. The potential, hardworking and extraordinary talent that we have in India will fructify only by proper regulation and implementation by the government and later by companies. A bold initiative was taken by the government to frame which can be used as a model. Thus a commendable document from the panel was prepared. In 2009, 15 alliances were made globally out of which 12 percent was from Indian companies indicating that we are on the right track. The investments made in the biosimilars are many times more than that in generics. Regulation is going to be the key for targeting and propelling a growth in the next two years .There is a criticism regarding the guidelines i.e. it is suited only for for semi-regulated markets and not for fully regulated markets like the US. For every company regulation must be an enabler and not disable its progress." The biosimilar guidelines are evolving. The guidelines depend on how every country interprets it. Dr Abhijit Barve, added, "Europe is the front runner in the biosimilars, they regulated the tricky issue of how many clinical trials is important for the efficiency and clarity of the drug. The WHO guidelines are very similar to that of Europe's. The pyramid of biosimilars should have a robust foundation with many steps that make it up like the funding, studies, research, and availability. The Indian guidelines are quite similar in comparison with the WHO and European guidelines. The roadmap to Indian guidelines is mainly about the safety and the effectiveness of the product. To raise funds for a biopharmaceutical franchise there are two main important aspects namely the reference drug and the interchangeability law. The source of the reference drug and the materials used, since the laws in the US and the UK are very strict and they do not allow any reference drug from any other country. So, the FDI is helping the semi-regulatory markets in reference drug issue. The second being the interchangeability laws whether biosimilars can be used for conservative drugs. The product quality should meet the requirements of all the people around the globe. The prices of biosimilar will be huge so there should be a robust bottom of the pyramid and safety is paramount to all patients all over the world." Dr William Lee, commenting on the global perception of India, said, "Biosimilars is a frontier in pharma. India plays an important role in pharma industry in providing cost effective drugs and if it continues so India will be the 'major player in the biosimilar space'. India has to converse all over the world to make its strong presence. India must focus on its positioning which is very important and it should be done quickly." Highlighting the path to global stature, Dr Subir Kumar Basak, said, "The biopharmaceuticals companies in India now have many global partners and they have been developing many affordable and efficient drugs since the last 10 years though there was a lot of resistance initially from all the world for Indian drugs. For the development of high quality drugs the biologicals are very important along with huge investments, technology and other works. Eastern Europe, Latin America and South Korea have given access to Indian products." The speakers agreed that India has a good ecosystem and it does not allow sub-standard medicines to be marketed so easily. Many innovative companies have moved out of biosimilar guidelines since everybody wants standard care for oncology and monoclonals. The UK and the US have the most expensive monoclonals and standard care. Many companies are now investing in the technology and scientific ability of biopharmaceuticals. The small hurdles faced in biosimilar guidelines have to be analyzed and prevented before it becomes a big issue for the government as well as the public. The game will shift from biosimilars to biobetters. Dr Kamboj concluded the discussion summarizing that, "The patent laws in India respect the patents except during emergency and the innovators have tendency for evergreen innovations. The market expectancy of patent life is aimed in India not only for semi-regulated markets but also for non-regulated markets. The guidelines respect safety and ethnic variations in every country must be looked on. At least about five Indian drugs should enter the European market and also aim for the US market in the following year. The guidelines will be revised periodically as per the requirements." ]]> <![CDATA[GSK increases stake in healthcare subsidiary to 72.5 %]]> https://biospectrumindia.com/news/95/3029/gsk-increases-stake-in-healthcare-subsidiary-to-72-5-.html https://biospectrumindia.com/news/95/3029/gsk-increases-stake-in-healthcare-subsidiary-to-72-5-.html Tue, 05 Feb 2013 16:36:50 +0530 GlaxoSmithKline (GSK) has announced that, in pursuant to the voluntary open offer undertaken by its subsidiary, GSK has successfully increased its stake in GlaxoSmithKline Consumer Healthcare, its publicly-listed Consumer Healthcare subsidiary in India, from 43.2 percent to 72.5 percent. Mr David Redfern, chief strategy officer, GSK said, "We are very pleased with the outcome of this transaction, which will further increase our exposure to a key emerging market. It is a significant vote of confidence in the long-term growth prospects of our Consumer Healthcare business in India." During the offer period, which commenced on January 17, 2013 and closed on January 30, 2013, shareholders of GlaxoSmithKline Consumer Healthcare validly tendered 12,319,749 shares representing 29.3 percent of the total shares outstanding. The offer of INR 3,900 per share values the transaction at approximately INR 48 billion or £568 million (based on prevailing foreign exchange rates). The final payment for shares tendered and accepted will be completed on or before February 13, 2013, at which point GlaxoSmithKline would acquire full beneficial ownership of the shares tendered in the open offer. The open offer was first announced on November 26, 2012 and is being managed by HSBC Securities and Capital Markets (India). ]]> <![CDATA[Final countdown for Grand Challenges Canada]]> https://biospectrumindia.com/news/95/3820/final-countdown-for-grand-challenges-canada.html https://biospectrumindia.com/news/95/3820/final-countdown-for-grand-challenges-canada.html Tue, 05 Feb 2013 16:15:00 +0530 The proposed deadline for 'The Stars in Global Health' program from Grand Challenges Canada, which enables innovators to develop bold ideas with big impact to improve global health conditions is now only two days away. The program was developed to tap innovative ideas from leaders in global health and consists of proof-of-concept awards of $100,000 CAD (or $100,000 USD) as phase I grants, and phase II transition to scale funding to successful applicants for up to $1,000,000 CAD. The proposal deadline is February 6, 2013. The proposed innovations must address complex real-world challenges using an integrated innovation approach that is the coordinated application of scientific/ technological, social and business innovation to develop solutions to complex challenges. Past awardees include innovative Indian companies such as Bangalore-based Achira Labs and Bigtec Labs in 2011 in a challenge to invent and deliver low-cost devices to rapidly diagnose diseases in developing countries. Bigtec recently launched their mini PCR, a point-of-care diagnostics for infectious diseases in the overseas market. Innovators who are eligible to apply include those from low-income countries, lower-middle-income countries, upper-middle-income countries of Association of Southeast Asian Nations (ASEAN) and Canadian International Development Agencies (CIDA) Countries of Focus Canada. Since July 2011, Grand Challenges Canada has approved over 100 phase I proof-of-concept grants, each at $100,000 CAD. These projects run across the whole spectrum of global health, from drug discovery, vaccine development, health and medical education, maternal and child health, non-communicable diseases (including cancer), health-related water and agriculture, information communication technologies and behavioral change. Phase I grantees who have completed a minimum of nine months of their Grand Challenges Canada grant, completed their proof-of-concept projects and will have solutions that are ready to transition to scale are invited to submit phase II transition to scale proposals. Phase II transition to scale grants will require 50 percent matching through partnerships to be eligible for Grand Challenges Canada funding. ]]> <![CDATA[Rotary International honors Doctors Without Borders]]> https://biospectrumindia.com/news/95/4621/rotary-international-honors-doctors-without-borders.html https://biospectrumindia.com/news/95/4621/rotary-international-honors-doctors-without-borders.html Tue, 05 Feb 2013 15:13:01 +0530 The global humanitarian organization, Rotary International has presented its World Community Excellence award to the International Medical Organization, MÃ©decins Sans FrontiÃ¨res (MSF) or Doctors Without Borders. The award was presented at the annual conference of Rotary International District 3140 in India on February 2, 2013 at Aamby Valley, Pune. MSF has been working in India since 1999. It has also been an active voice in public advocacy for affordable medicines for the masses and raised issues regarding compulsory licensing in Indian pharma and patent suits such as the Novartis Glivec case. In Mumbai, it runs a centre that provides comprehensive HIV care for patients with specific medical needs, such as those also infected with multidrug-resistant tuberculosis. Elsewhere in India, MSF provides basic healthcare and secondary medical care, as well as specialist care for HIV/AIDS, tuberculosis, kala azar, mental health issues and malnutrition. It currently runs medical programs in states including Andhra Pradesh, Bihar, Chattisgarh, Jammu and Kashmir, Manipur and Nagaland. Dr Inamdar, district governor of Rotary International District 3140 said that, "MSF has done monumental work in areas torn by strife, war and community upheaval. It is a non-political and non-religious organization par excellence, which undoubtedly deserves this award". Accepting the award, MSF's international president, Dr Unni Karunakara, said, "Today, some 30,000 MSF doctors, nurses, surgeons, psychiatrists, logisticians, engineers, and support staff provide medical care to people caught up in conflict, affected by natural disasters or epidemics, or simply excluded from health services in more than 70 countries around the world. Our motivation remains as it was in 1971, the year MSF was formed: we are humanitarians." MSF has also provided medical care during several emergencies in India, from treating victims of the earthquake in Gujarat in 2001 to those affected by violent clashes in Assam in 2012. On February 2, 2013, MSF distributed relief items, including cooking utensils, hygiene essentials and shelter materials, to people affected by a fire in Mahim slums of Mumbai.MSF offers healthcare to people based only on need, irrespective of race, religion, gender or political affiliation. This award recognizes the organization's work around the world and its commitment to improve people's access to lifesaving healthcare. MÃ©decins Sans FrontiÃ¨res (MSF) is an independent international medical humanitarian organization that delivers emergency aid to people affected by armed conflict, epidemics, healthcare exclusion and natural disasters in more than 70 countries. MSF offers healthcare to people based only on need and irrespective of race, religion, gender or political affiliation. ]]> <![CDATA[Dr Brahmachari: Genomics will fastrack healthcare]]> https://biospectrumindia.com/news/95/3028/dr-brahmachari-genomics-will-fastrack-healthcare.html https://biospectrumindia.com/news/95/3028/dr-brahmachari-genomics-will-fastrack-healthcare.html Tue, 05 Feb 2013 13:20:00 +0530 Dr Samir K Brahmachari, director general, Council for Scientific and Industrial Research (CSIR), feels that genomics will play an important role in future. At the Ranbaxy Science Foundation's (RSF) 19th annual symposium on "Gains of Genomic Research in Biology and Medicine" held on February 4, 2013 at the National Institute of Immunology, New Delhi, he spoke about the importance of open innovation in sharing ideas and research insights. Sharing his thoughts with BioSpectrum, Dr Brahmachari called the symposium very thought provoking. He explained, "These kinds of deliberations prepare us for future. I am sure we will meet the challenges of making healthcare affordable. India right now is in a mode of discovery and we shall not stay in generic forever. For that we have to also concentrate on genomics in a big way, as this is the area that can bring a major paradigm shift. India is a melting pot in the world population and we have the strength to carry forward the genomics research at a huge scale for developing the predictive and personalized medicine." Complimenting Ranbaxy for such an initiative, he added, "Industry houses must support good science and Ranbaxy has done it again and again. Others too must keep contributing." Earlier while addressing the audience, he mentioned that $5 million boost has been given to the generic drug industry by the government of India. "This is an important step for making the drugs affordable. Streptokinase developed by the Institute of Microbial Technology (IMTECH) over the period of years, is a perfect example of bringing down the cost drastically," said Dr Brahmachari. Eminent scientists from India and abroad deliberated on all aspects of R&D in genomics to address major challenge in India. Later in the evening, RSF's 27th annual research awards for the year 2011 were presented to researchers by Prof. Dhavendra Kumar, consultant in Clinical Genetics, Institute of Molecular and Experimental Medicine, University Hospital of Wales, Cardiff, UK. ]]> <![CDATA[Ranbaxy honors outstanding researchers ]]> https://biospectrumindia.com/news/95/3022/ranbaxy-honors-outstanding-researchers-.html https://biospectrumindia.com/news/95/3022/ranbaxy-honors-outstanding-researchers-.html Tue, 05 Feb 2013 11:30:00 +0530 Ranbaxy Science Foundation (RSF), a non-profit organization set-up by Ranbaxy Laboratories (Ranbaxy), announced its 27th Annual Research Awards for the year 2011 to Indian Scientists in recognition of their outstanding research contributions made in the fields of medical and pharmaceutical sciences. The foundation also announced its 6th annual science scholar awards to the young and brilliant upcoming new generation of scientists. The awards were presented by the internationally acclaimed scientist, Prof. Dhavendra Kumar, consultant in Clinical Genetics, Institute of Molecular and Experimental Medicine, University Hospital of Wales, Cardiff, UK, at a special function held on February 04, 2013 at New Delhi. Ranbaxy's chairman, Dr Tsutomu Une, Padma Shri awardee Dr Nitya Anand, chairman of RSF, Mr Arun Sawhney, CEO and MD, Ranbaxy and Dr Sudershan Arora, president, R&D, Ranbaxy also addressed the gathering. A total of four scientists and four science scholars were honored with the awards. Category: Medical Sciences - Basic Research Prof. Tapas Kumar Kundu, transcription and disease laboratory, molecular biology and genetics unit, Jawaharlal Nehru Centre for Advanced Scientific Research Significant contributions in the area of epigenetics and gene regulation with special emphasis on disease. He has also developed a nano device to induce acetylation of histones in the mice brain which could be highly useful for the treatment of neurodegenerative diseases. Category: Medical Sciences - Medical Research Dr Satish Kumar Gupta, deputy director, National Institute of Immunology (NII) and chief, reproductive cell biology laboratory, NII Outstanding contributions to the understanding of the molecular basis of mammalian fertilization. Category: Clinical Research Prof. Arun J Sanyal of Virginia Commonwealth University, School of Medicine Pioneering work in the areas of nonalcoholic fatty liver disease (NAFLD) and cirrhosis. NAFLD affects over a third of the population and independently increases the risk of cirrhosis, diabetes and cardiovascular disease. Category: Pharmaceutical Sciences Dr Navin Khanna, senior scientist and group leader, mammalian biology:recombinant gene products, International Centre for Genetic Engineering and Biotechnology Contribution in the development of novel recombinant designer proteins as inexpensive, highly sensitive and specific diagnostic intermediates for viral infections. Among the four research scholars who were awarded under different categories include: Biomedical Sciences: Mr Manish Goyal, senior research fellow, Division of Infectious Diseases and Immunology, Indian Institute of Chemical Biology Ms Seema C Parte, senior research fellow, Stem Cell Biology Department, National Institute for Research in Reproductive Health Pharmaceutical Sciences: Mr Pawar Yogesh Bapurao, Department of Pharmaceutics, National Institute of Pharmaceutical Education and Research Ms Aakanchha Jain, Department of Pharmaceutical Sciences, Dr Hari Singh Gour University. ]]> <![CDATA[Karnataka CM supports biotech innovation]]> https://biospectrumindia.com/news/95/7902/karnataka-cm-supports-biotech-innovation.html https://biospectrumindia.com/news/95/7902/karnataka-cm-supports-biotech-innovation.html Tue, 05 Feb 2013 11:02:49 +0530 "The government of Karnataka will provide the necessary support to promote biotechnology innovation in the state. The biotech park, which is to be operational in next two years will add more strength to the state's biotech industry," said Mr Jagadish Shettar, Chief Minister of Karnataka, after inaugurating the 13th edition of the three day India's premier biotech forum - Bangalore INDIA BIO organized by the Department of Information Technology, Bio-Technology and Science and Technology, Government of Karnataka and the Vision Group on Biotechnology at Bangalore. He further said, "As the Prime Minister of India declared that this is the decade of innovation and Karnataka has already signed a few Memorandum of Understanding (MoUs) with international agencies, which will pave the path of growth and development of the industry in the state." Mr SV Ranganath, chief secretary, government of Karnataka, said, "Biotechnology has given great opportunity to a country like India with 1.2 billion population, which has good potential to tap the benefits of pharmaceuticals and agro biotech. India is particularly concerned with agro and disease control at affordable price with quality to rural part. India with a huge population and minimal resource is greatly working on affordable innovations in the field of agro, pharma, health. It is estimated that by 2050 the population of the world will be nine billion and most of it being from developing countries. The heat of the population will be felt in the field of food, fuel, and health." He further said, "India has high manpower and talent in the field of life science, engineering science and R&D. And there by the MNCs are looking at India for collaboration for the above reasons. Bangalore has many number of R&D in public and private sector. Bangalore is the hub for R&D and constitutes to about 56 percent of the Indian R&D. State government has taken initiatives to provide 4000 acres of land for the development of Biotech and other sciences. Indian Institute of Nano Science has also been allotted 14 acres for the same purpose." In his address, Prof. K VijayRaghavan, secretary, Department of Biotechnology, Ministry of Science and Technology, Government of India, said, "There are a range of the issues we have to tackle in order to make this a $100 billion industry, opportunities are available but connections and communication are required for bridging the gap." Ms Anne MacColl, exchanged the MoU signed between Scottish Development International (SDI), Scotland and Karnataka Biotechnology and Information Technology Services (KBITS) with Mr Vijay Shankar, MD, KBITS and similarity Mr Mark Lytle, division director, Georgia Centers of Innovation; Georgia Department of Economic Development, Atlanta exchanged the documents related to biotechnology. Prof. K VijayRaghavan, secretary, Department of Biotechnology, Ministry of Science and Technology, Government of India, released the industry reports titled "Indian Biotechnology: The roadmap to the Next Decade and beyond" and "Funding Your Science Idea" of Atharva Life Sciences Consulting, while Dr Kiran Mazumdar-Shaw, chairperson, Karnataka Vision Group on Biotechnology; chairman and managing director, Biocon released the Association of Biotechnology Led Enterprises (ABLE) report "Opportunities for Fermentation Industry and Biotechnology." ]]> <![CDATA[Anti-GM apprehensions are misplaced, says Pawar]]> https://biospectrumindia.com/news/95/4409/anti-gm-apprehensions-are-misplaced-says-pawar.html https://biospectrumindia.com/news/95/4409/anti-gm-apprehensions-are-misplaced-says-pawar.html Mon, 04 Feb 2013 12:12:41 +0530 The union minister for agriculture, Mr Sharad Pawar has once again openly raised his voice in support of genetically modified crops. Addressing a national conference on 'Doubling Food Production in Five Years' at Vigyan Bhavan, New Delhi on February 1, 2013, Mr Pawar said, "Increase in agricultural production would have to come mainly from enhancement in farm productivity in the existing cultivated area. I am of the firm opinion that we must adopt the modern scientific solutions which are based on sound and proven practices. We also cannot afford to curtail the vigor of our scientific community if they are conducting research with all the precautions. We should not get carried away by the misplaced apprehensions against the scientifically proven developments (such as GM crops)." The minister stated that India will need to ensure sustainable agricultural growth against the limited availability of natural resources, especially cultivable land. About the question regarding the challenges before Indian agriculture, he said, "Our farmers have the enormous task of feeding a billion plus population. Increased focus on enhancing agricultural production has its own challenges, on account of progressive fragmentation of land holdings, depleting natural resource base and emerging concerns of climate change." The minister highlighted the role of the private sector and drew the attention of the conference to the need for sustainability and farmers' profitability. He said, "Private sector seed companies have made contributions by introducing frontier technology which has truly revolutionized yields in some crops. Further research needs to be carried forward for securing breakthroughs in yields in dry land farming conditions faced with biotic and abiotic stresses. Private sector also needs to come forward in innovative ways, like custom hiring facilities for farm machines. The government would be supportive of public-private partnership in agriculture and the framework for facilitation has been put in place. Private sector companies have very large dealership networks in rural areas and training of dealers can be considered with a view to bolster extension machinery in dissemination of technology and information." The president of India, Mr Pranab Mukherjee who earlier inaugurated the conference said, "With a growing population, the challenge before us is not only to ensure that the indicators of food security do not deteriorate, but instead show improvement." He emphasized that food production therefore deserves high priority in our national policy formulation. ]]> <![CDATA[Technology to detect GM products in India]]> https://biospectrumindia.com/news/95/5022/technology-to-detect-gm-products-in-india.html https://biospectrumindia.com/news/95/5022/technology-to-detect-gm-products-in-india.html Mon, 04 Feb 2013 11:39:44 +0530 Scientists argue that genetically modified (GM) crops are engineered to convey favorable traits such as disease resistance. However, at the same time, the labeling and identification of genetic modifications in commercial products have become a global concern. In India, the ministry of consumer affairs, food and public distribution on January 1, 2013, formally implemented a rule which stipulates that every package containing food derived from products of biotechnology shall bear at the top of its principal display panel the letters "GM". With this kind of regulation in place, it is the implementation part that has become important for the authorities. At present, in India, there is availability of a technology that may be of help to the industry, especially agri-biotech sector and the regulators. This technology "Fluidigm Biomark HD System with Dynamic Array Integrated Fluidic Circuits (IFCs)" priced between Rs1-2 crore depending on the specific system, has been brought to India by New Delhi-based Premas Lifescience, the biosupplier division of Premas Biotech. The researchers through a study have claimed to demonstrate the utility of this system, which is also called as qdPCR 37K (37K) IFCs for real-time GM detection. The real time analysis provided Ct values that identifed false positives and provided greater data confidence. They used Gossypium hirsutum genome (cotton; C=2.40; GM free) and GM event GHB 614 (614) detected by their respective TaqMan assays, to determine the limit of GM detection on the 96.96 IFC and 192.24 IFC for real-time PCR and the 37K IFC for quantitative digital PCR (qdPCR). In this case the pre-amplification was not found to be necessary. The study has concluded that the system enabled fast and accurate methods of low-level GM contamination detection in a high background of GM-free plant gDNA. The executive director of Premas, Mr Praveen Gupta looks at it as an important step towards offering choice to consumers. Revealing his targeted market to BioSpectrum, he explained, "The market we are looking at includes seed companies, GMO testing labs, agri-genetics research universities and institutes. The technology will be used to assure purity and segregation of different events and to trace the genetic modifications by the seed companies and food industry. Also the enforcement agencies can use it to ensure compliance with legislation." ]]> <![CDATA[Lupin posts 42.6% growth in net profits in Q3 ]]> https://biospectrumindia.com/news/95/3041/lupin-posts-42-6-growth-in-net-profits-in-q3-.html https://biospectrumindia.com/news/95/3041/lupin-posts-42-6-growth-in-net-profits-in-q3-.html Fri, 01 Feb 2013 15:30:24 +0530 Pharma major, Lupin reported its performance for the third quarter ended December 31, 2012. Key highlights included the net sales growth by 37.6 percent to Rs. 24,659 million during Q3 FY 2012-13, up from Rs. 17,917 million in Q3 FY 2011-12. Also Net profits grew by 42.6 percent to Rs. 3,352 million during Q3 FY 2012-13, up from Rs. 2,351 million in Q3 FY 2011-12.Commenting on the results, Dr Kamal K. Sharma, Managing Director, Lupin Ltd, said "We had a record quarter driven by strong operating performance and growth in the US. Importantly, we continue to improve on margins consistently." The US & Europe formulation sales contributed 44 percent to the company's overall consolidated revenues for Q3 FY 2012-13. Formulation Sales for US and Europe grew by 60 percent to Rs. 10,829 million during Q3 FY 2012-13, as against Rs. 6,763 million in Q3 FY 2011-12, while the Indian formulations contributed 23 percent of the Company's overall revenues for the quarter. The company's India formulations business grew by 14 percent recording net revenues of Rs. 5,708 million during Q3 FY 2012-13, as compared to Rs. 5,011 million. in Q3 FY 2011-12. Revenue expenditure on R&D for Q3 FY 2012-13 amounted to Rs. 2,382 million, 9.7 percent to net sales as against Rs. 1,410 million, 7.9 percent to net sales in Q3 FY 2011-12. Lupin filed 8 ANDAs and received 3 approvals from the US FDA during the quarter. The Company withdrew 16 ANDA's which were pending for approval with the US FDA. Cumulative ANDA filings with the US FDA as of December 31, 2012 stood at 168 with the company having received 68 approvals to date. The company filed 2 MAAs with European regulatory authorities during the quarter & has received 2 approvals as well. Cumulative filings with European authorities now stand at 49 with the company having received 34 approvals to date. ]]> <![CDATA[United Nations extends partnership with DSM to combat hunger]]> https://biospectrumindia.com/news/95/3042/united-nations-extends-partnership-with-dsm-to-combat-hunger.html https://biospectrumindia.com/news/95/3042/united-nations-extends-partnership-with-dsm-to-combat-hunger.html Fri, 01 Feb 2013 15:22:06 +0530 Royal DSM, the global Life Sciences and Materials Sciences company, and the United Nations World Food Programme (WFP), the world's largest humanitarian organization fighting hunger around the world, have signed an agreement extending their existing partnership for three years (to 2015) to combat hidden hunger and malnutrition in the developing world. DSM and WFP will seek to double the number of people, who benefit from their work together, from the current annual reach of 15 million to 25-30 million per year by 2015. DSM's public-private partnership with WFP, in place since 2007, has contributed to improving the diets of people, using essential vitamins, nutrients and fortified rice, in countries that include Nepal, Kenya, Bangladesh and Afghanistan. The strengthened partnership will focus on pregnant and nursing women, young children and vulnerable households. Feike Sijbesma, CEO and Chairman of the DSM Managing Board, said: "DSM's mission is to provide brighter lives for people today and generations to come. Our partnership with the UN WFP is about improving nutrition and fighting micronutrient deficiencies. As the world's largest producer of vitamins and other micronutrients we have a clear responsibility to help solve the globe's most solvable problem: hidden hunger. DSM is immensely proud of our partnership with WFP and intensifying this successful relationship has yielded the ambitious plan of more than doubling the number of beneficiaries over the next three years." Ertharin Cousin, Executive Director, UN World Food Programme, stated: "Investing in nutrition solutions for the world's most vulnerable people is an essential element of the fight against global hunger. With DSM's continued support, WFP is committed to providing the right food at the right time, especially for children in the first 1,000 days of life. When building the potential of future generations, there is no substitute for good nutrition." As one of WFP's Global Humanitarian Partners, DSM combines technical and scientific expertise with high- nutrient products and financial assistance to help improve the nutritional value of the food WFP distributes to those in need. DSM supports WFP operations around the world through the addition of critical vitamins, minerals and other micronutrients to WFP's food basket Through the partnership with WFP, DSM has used its unique scientific expertise in health and nutrition to develop micronutrient innovations that meet the specific nutrition needs of the people WFP supports, including ready-to-use sachets of vitamins and minerals that can be added to food (MixMe), as well as fortified rice (Nutririce). DSM has also helped WFP improve the formula of its fortified blended foods. DSM and WFP will continue to trial and test new products and programs that tackle hidden hunger and malnutrition. DSM will also continue assisting WFP in implementing its nutrition strategy at national, regional and global levels, providing on-going technical and scientific support and supplying food supplements and food fortification products. An estimated 2 billion people globally suffer from the effects of micronutrient deficiencies, in that they don't receive the necessary levels of vitamins and minerals that allow them to develop to their full mental and physical potential. This hidden hunger has a major impact on child development, educational attainment, economic productivity and can lead to chronic diseases and higher mortality. Royal DSM is a global science-based company active in health, nutrition and materials. DSM's 22,000 employees deliver annual net sales of around â‚¬9 billion. The company is listed on NYSE Euronext. ]]> <![CDATA[Gujarat is a peaceful state says Investor]]> https://biospectrumindia.com/news/95/6314/gujarat-is-a-peaceful-state-says-investor.html https://biospectrumindia.com/news/95/6314/gujarat-is-a-peaceful-state-says-investor.html Fri, 01 Feb 2013 14:26:00 +0530 "Gujarat is a peaceful state. It has proactive government. Located in the middle of the country, it offers an easy access to reach to country sides. Besides, it has maximum sea ports, good air travel access, good Infrastructure such as roads, railways, uninterrupted electricity supply, transports etc., skilled and technically sound human resource, good state agricultural universities." These are words, Mr Ramji Mangukia, Director of a small agribiotech company - Agriland Biotech has to say about Gujarat as a biotech investment destination at the 'Vibrant Gujarat 2013: Global Investors Summit' concluded on January 13 at Gandhinagar. Total Investment Intentions for 17,719 projects, including 12,886 in SME sector, promising jobs to 0.37 million were announced at the sixth version of Vibrant Gujarat, Gujarat Government's flagship mega event that was attended by top functionaries of governments, captains of industries and investors, management experts, dignitaries and delegates. A total of 2,100 representatives from 121 countries have attended 127 seminars on different topics. Agriland Biotech, actively involving in the promotion of biological, organic and environment-friendly agricultural products, plans to invest less than Rs 2 crore in creating employment opportunity to about 20 persons in Gujarat in coming period. Speaking to BioSpectrum, Mr Ramji Mangukia said, " Gujarat Horticulture Mission and Gujarat State BioTechnology Mission are rendering financial help to the entrepreneurs. Besides, the government offers assistance to expedite the commissioning units and helps in promoting markets as well." Agriland is constantly endeavoring in to biological process innovations and exploring the possibilities of plant protection and plant nutrition products of high field efficacies. Pioneered with biological plant protection products in 1994, the company has undertaken the world class manufacturing technology called Surface Technology, a second big jackpot to the farmers of India. High potency plant protection products are being manufactured by using new technology. "We already have huge capacity to produce. Our quality products, have been contributing their best in solving plant protection problems. We are looking for partners to expand our reach in the country as we are keen on catering to the needs of the are in exports too, but our priorities are to cater to the needs of our country farmers first, B2B on the send and thirdly the overseas, " Mr Ramji Mangukia added. ]]> <![CDATA["The world is looking at India" ]]> https://biospectrumindia.com/interviews/95/3040/the-world-is-looking-at-india-.html https://biospectrumindia.com/interviews/95/3040/the-world-is-looking-at-india-.html Mon, 04 Feb 2013 13:17:00 +0530 Scottish Development International (SDI), the international arm of the Scottish Government responsible for developing and strengthening trade and investment between Scotland and the rest of the world, has associated with Bangalore INDIA BIO 2013 as Innovation Partner and bringing in delegation to India. The delegation led by Ms Anne MacColl, CEO, Scottish Development International, Scotland will be signing Memorandum of Understanding with Karnataka Biotechnology and Information Services (KBITS) during the event and paving way for better Knowledge exchange and trade relations with the two nations. In this regard BioSpectrum spoke to Mr Mark Dolan, Country Manager, Scottish Development International (SDI), India about his views about the opportunities and strengths of Scotland in life sciences space. Excerpts of the interview, What is the current status of trade between India and Scotland in general and life sciences space in particular? Ever since India opened up its economy, there has been a tremendous increase in trade and investment between India and other countries. India's relationship with Scotland is no different in that respect and we have seen a healthy increase in both trade and investment between both the countries. In the last three years, we have seen an increase of 30 percent in the number of Scottish companies, who we have supported to set up and develop their business in India (across sectors). In fact, we have a strong delegation of life sciences companies who are here at Bangalore India Bio to explore opportunities. Prof Charles Ffrenchconstant, a well known figure in the life sciences community will be speaking at the event and so is Dr Pradeep Ramyya from Axsys Technologies, who have set up a successful life sciences business in Glasgow. So, the business relationship between the two countries is definitely becoming stronger. For the life sciences sector particularly, we have companies like Omega Diagnostic, a Scottish company that manufactures, develops and distributes medical diagnostic products and in-vitro diagnostic test kits for infectious diseases, allergy, food intolerance and autoimmune diseases that established its India office in 2012. Touch Bionics a leading developer of advanced upper-limb prosthetics and known for developing the i-LIMB hand - the world's first fully articulating and commercially available bionic hand is actively looking to tap into the Indian market. There's a similar trend, when we look at investment from Indian companies into Scotland across sectors. There are 15 Indian companies that have set up base in Scotland adding around 5000 high value jobs to the Scottish economy. There are companies like Piramal Healthcare as well Axsys Technologies doing some good work in Scotland. Not only are we seeing collaboration between companies, we are also seeing a trend where well known Indian hospitals and medical institutions are partnering with Scottish Universities to develop joint curriculum for post graduate and short term programmes in biology and bio medical science. For example, Glasgow Caledonian University (GCU) has partnered with renowned private hospitals and institutions such as Sitaram Bhartia Institute of Science and Research, Lilavati Hospital, Max Healthcare, MV Hospital of Diabetes and the Kerala Institute of Medical Sciences for the delivery of its innovative diabetic footcare courses. What are Scotland's strengths in life sciences space? Scotland hosts one of the largest life science clusters in Europe with significant international presence in research, development and manufacturing. With a long and remarkable history of medical and scientific discovery stretching back 200 years, Scotland has always been at the forefront of medical innovation. It is no surprise then that we were asked to be the innovation partners at the Bangalore India Bio this year.Scotland is home to some of the best known life sciences companies across the globe including: Quintiles, PPD, Charles River Laboratories, Kendle and Aptuit - in the top 10 major global Contract Research Organisations (CROs) and are all at the forefront of improving drug development processes through scientific excellence Pfizer - at the cutting-edge of research and development of human and animal medicines Life Technologies - a global provider of premier biotechnology systems, consumables and services Merck Sharp & Dohme (MSD) - a global player in discovery, development, manufacture and marketing of a wide range of innovative pharmaceutical products to improve human health. While Scotland has existing strengths, in key business areas such as medical technologies and pharmaceutical services, where there is already a substantial local company base, ranging from innovative start-ups to global multinationals. We also have research excellence, particularly in areas such as stem cells and regenerative medicine and clinical/ translational medicine, where there are significant current and emerging commercial opportunities. Over the years, Scottish Universities and research institutes have contributed significantly to the life sciences sector globally through world leading research in areas such as: The development of MRI and CAT scanners The discovery of p53 cancer suppressor gene World-recognised research in diabetes and cancer ReNeuron's groundbreaking stem cell trial for stroke patients A number of exciting new opportunities have also now been identified (resulting from global economic and health trends), which could deliver significant economic impact in the future. These include areas such as assisted living, stratified medicine, wellness and sustainability. What opportunities can Scotland offer in the life science space? Globally, the life sciences sector (including pharmaceuticals and biotechnology) is expected to be worth £801 billion, representing an increase of more than 45 percent since 2007. A number of significant global trends are identified as shaping the future of the life sciences and biotech in Scotland, including: The emergence of personalized medicine The growing trend by big pharmaceuticals towards corporate investment, partnerships and outsourcing An increasing move towards translational medicine and the use of biomarkers and associated diagnostics to improve the efficiency of the drug discovery process Increasing convergence with further integration between drugs and technology Increasing use of information technology to accelerate discovery and drive down costs Increasing emphasis on the search for alternative therapies for existing approved drugs. World's most well known and respected MNC's have set up base in Scotland because, of the five most significant aspects of any business that Scotland offers. These are - knowledge , people, innovation, infrastructure and collaboration. When one talks of the opportunities that we offer in this space, we need to look at the areas where we excel and areas where we can share the success with international companies. These are: Medical technology - Diagnostics and medical devices Pharma services including contract research and pre-clinical and clinical trials support Stem cells and regenerative medicine research Drug discovery and development Translational medicine Therapeutic areas Bioinformatics. We have invested in high-tech infrastructure for supporting the life sciences sector in Scotland and have developed some high-class facilities like Aberdeen's Science and Technology Park, Glasgow's West of Scotland Science Park, Dundee's Ninewells Site, the BioCity Campus and the Edinburgh BioQuarter. Government support and the capabilities of Scotland's company base, makes it ideally placed to capture a larger share of the global market and become an internationally significant location for life sciences and biotech. Given this context, when we talk about the life sciences sector in India, we see huge opportunity for collaboration on various key areas, such as: Drug research and development: The sheer number and scale of the market makes India a very attractive destination for foreign companies. However, the Indian clinical research sector is still at an embryonic stage. Indian organisations are being actively approached by foreign companies and they have the capability to develop a global footprint for themselves. However, there are some gaps that have been reported. By collaborating with the Scottish life sciences industry, Indian companies can aim to fill those gaps through exchange of know how and sharing of best practices. Stem cell research and translational medicine: India is expected to be in the forefront of stem cell research with a market growth potential and a compound annual growth rate (CAGR) of 25 percent or more by 2015. Scotland is renowned for its commercially attractive academic and clinical strengths within the field of translational medicine and Scottish scientists continue to address the key medical challenges with ground-breaking stem cell research. Stem cell researchers can join forces to help facilitate a positive outcome for the development of novel therapeutics using stem cells. Recently, doctors in Edinburgh and Glasgow performed a surgery to treat corneal blindness using stem cells. This trial is currently being carried out on twenty people suffering from corneal blindness. It involves the National Blood Transfusion Services and is being funded jointly by the UK Stem Cell Foundation and Scottish Enterprise in partnership with the Chief Scientist's Office. Contract Research Organisations (CRO): The local $485 million clinical research market is growing at a 11-13 percent as the country gains increasing favour as a base for global clinical trials (phase I-IV), it said. However, increasing competition, quality concerns and lack of quality infrastructure in smaller tier II sites are some factors that impacted the growth rate of the CRO market. There is a wealth of experience in Scotland for the CRO market. The strong links between academia and industry and the government support to develop infrastructure to support some of the world's best life sciences companies, makes it a natural partner to help Indian CRO sector to improve ad develop to its full potential. Medical Technologies: The world is looking at India and India has come up very strongly as a top destination for medical tourism. Many of the latest medical technologies are being developed in Scotland - for example the Bionic hand which is the closest to actual hand movements as a prosthetic could be. With such innovative technologies coming from Scotland, India can certainly benefit by collaborating and can position itself higher on the value chain. ]]> <![CDATA[WHO-endorsed rapid TB test brings hope to India]]> https://biospectrumindia.com/news/95/3038/who-endorsed-rapid-tb-test-brings-hope-to-india.html https://biospectrumindia.com/news/95/3038/who-endorsed-rapid-tb-test-brings-hope-to-india.html Fri, 01 Feb 2013 11:46:00 +0530 According to a new systematic review which evaluates the diagnostic accuracy of the multidrug-resistant TB diagnostics GeneXpert MTB/RIF test published on January 31, 2013 in The Cochrane Library, the results have shown that the Xpert test can be a replacement for smear microscopy. The researchers from the Cochrane Infectious Diseases Group, McGill University and the Foundation for Innovative New Diagnostics (FIND), analyzed the data from 18 studies involving a total of 7,816 people, with most studies being carried out in low- and middle-income countries. According to the authors, the study can provide timely advice for clinicians and policymakers in countries where TB is a major public health problem. The information in this regard was provided to BioSpectrum by Dr Madhukar Pai, assistant professor and Canadian Institutes of Health Research (CIHR) new investigator, McGill University, who is among the seven researchers who authored the report. In India, the growing drug resistance is a major health problem that further complicates efforts to control TB. The multidrug-resistant TB is defined as the one which is resistant to rifampicin and isoniazid, the two of the most effective and widely used anti-TB drugs. Speaking of which, WHO has endorsed the Xpert test (Cepheid, California) that simultaneously detects TB and resistance to rifampicin, as an indicator of multidrug resistance. The test takes around two hours with minimal hands-on technical time required. Complimenting the efforts of researchers, Ms Lucia Ditzy, executive secretary of the Stop TB Partnership, said, "We welcome the Cochrane Review of Xpert, an innovation that represents a major milestone in our quest to achieve the goal of zero deaths from TB which is curable, but still takes the life of three people every minute. Our "TB Reach" initiative is deploying Xpert to numerous countries through projects that seek to increase the number of TB cases detected and treated, and these projects will deliver data that can provide an evidence base for determining how Xpert should be used for the greatest impact." Like sputum smear microscopy, which relies on detecting TB with a microscope in a laboratory, Xpert requires a sample of sputum. However, while thousands of bacteria must be present in each milliliter of sample for TB to be detected under the microscope, Xpert can detect TB bacteria at much lower concentrations. Additionally, the conventional microscopy approach does not detect drug resistance. Instead, TB has to be grown in the lab. This presents problems, especially for multidrug-resistant TB, due to the length of time required for the cultures to grow and highly skilled staff needed. The results showed that when Xpert is used to screen 1,000 people, 150 of whom have TB, it picks up 132 of the 150 cases (88 percent) and falsely diagnoses17 (2 percent) with TB. This is in a scenario where it is being used as a replacement for smear microscopy. In a scenario where Xpert is being used as a replacement for culture-based drug susceptibility testing, it is also able to detect the equivalent of 141 out of 150 cases (94 percent) of rifampicin resistance. When Xpert is used as a follow-on test, after conventional smear microscopy has already produced a negative result, it picks up 101 out of 150 cases (67 percent). By definition, smear-negative TB is not picked up by smear microscopy because microscopy cannot detect small numbers of bacteria. Xpert picked up 67 percent of this group that would have been missed by microscopy. "This study represents the most comprehensive review on the diagnostic accuracy of Xpert to date and may help countries make decisions about scaling up its use for management of TB and drug-resistant TB," said lead researcher, Ms Karen Steingart of Cochrane Infectious Diseases Group. Dr Karin Weyer, coordinator, laboratories, diagnostics and drug resistance at WHO believes that it is the high quality evidence provided by Cochrane Review that reinforces WHO's endorsement of this test. She said, "Recent price reductions have greatly facilitated roll-out of this technology, including a new three-year initiative called the TB Xpert Project, funded by UNITAID and executed by WHO and the Stop TB Partnership. About 1.4 million test cartridges and over 200 GeneXpert instruments for the rapid detection of TB and rifampicin resistance will be distributed in 21 countries with a high burden of TB." ]]> <![CDATA[Tata Capital invests Rs 45 crore in Marck Biosciences]]> https://biospectrumindia.com/news/95/3035/tata-capital-invests-rs-45-crore-in-marck-biosciences.html https://biospectrumindia.com/news/95/3035/tata-capital-invests-rs-45-crore-in-marck-biosciences.html Thu, 31 Jan 2013 18:50:00 +0530 Marck Biosciences, an Ahemdabad based manufacturer and marketer of sterile liquids pharmaceutical dosages using the Blow-Fill-Seal (BFS) technology, has sold a minority stake to Tata Capital Healthcare Fund. Tata Capital will invest Rs 45 crore in the company and has picked up a 13% stake in Marck Biosciences. IFCI Venture's 6% stake will also be acquired by Tata Capital Healthcare Fund. Hence Tata Capital will hold around 19% to 22% combined stake in Marck Biosciences. Marck Biosciences is targeting a top line growth of 62% while the PBDIT (Profit before interest, depreciation & taxes) is targeted at 37% and net profit to reach at 17-18%. Speaking on this occasion, Mr. Bhavesh Patel, MD, Marck Biosciences said, "It is a sustained growth phase for us at Marck Biosciences as we are investing Rs 80 crore in the new expansion project. The Fund Infusion from Tata Capital will be invested for further expansion of capacities of the new project which will have state of the art technology. Our entire project cost is expected to be around Rs 80 crores and hence we will also be going in for further funding through debt route. We expect returns from the funds infused within 6 to 8 months." Marck Biosciences is also actively seeking opportunities for growth and expansion in both markets, domestic and international. Hence the expansion of production facilities, product portfolio and markets becomes vital. ]]> <![CDATA[Mitra Biotech publishes key finding for head and neck cancer]]> https://biospectrumindia.com/news/95/8049/mitra-biotech-publishes-key-finding-for-head-and-neck-cancer.html https://biospectrumindia.com/news/95/8049/mitra-biotech-publishes-key-finding-for-head-and-neck-cancer.html Thu, 31 Jan 2013 18:30:00 +0530 Bangalore based Mitra Biotech recently published important findings the treatment of in Cancer Research, a journal of the American Association for Cancer Research. Although a large majority of head and neck cancers have a deregulation of the PI3K/AKT/mTOR pathway, Mitra Biotech has indicated through data,that deregulation of this pathway does not necessarily signify that the tumor is dependent on it for survival and progression. Even though treatment with mTOR inhibitors results in robust activity in certain cancer cell lines, they are not effective in all patients. Researchers are currently using biomarkers to try to stratify patients for response to mTOR inhibitors. "However, these technologies have limited success due to their inherent limitations in lack of clarity in distinguishing driver mutations in pathways from those of passengers," said Dr. Pradip K. Majumder,CSO, Mitra Biotech, Bangalore, India. The researchers led by Dr. Padhma Radhakrishnan,Director and Dr. Biswanath Majumder, Principal Scientist, Mitra Biotech, conducted a scientific experiment using tumor tissues from 22 patients with head and neck cancer. They have developed a novel ex-vivo platform to identify responders to Rapamycin, an mTOR inhibitor. However, a majority of the tumor samples did not have an antitumor effect after treatment with the mTOR inhibitor, possibly because Rapamycin is known to activate the AKT pathway. "This technology will reduce the time and resources for the development of new anti-cancer drugs in future and potentially bring down the cost of medicine for cancer" says Dr. Mallik Sundaram, President and CEO of Mitra Biotech. The study has taken place at Bangalore based Mitra Biotech, where for the last few years, researchers have been working on developing a mechanism to stratify patients according to their individual genetics and physiology, to understand the best possible therapy for a particular patient. Every year, over 16% of cancer deaths are attributed to head and neck cancer in India. Dr. Majumder told BioSpectrum that, "This sort of validation is very rare and especially rare from an Indian lab. The American Association for Cancer Research at Philadelphia,is a leading scientific peer-reviewed journal in this field." Dr. Majumder and colleagues used a systems biology approach called tumor explant model to distinguish driver mutations, or those that are critical for a tumor's survival, from passenger mutations. This distinction is important for stratifying patients for current treatments and for developing novel rational combinations of anticancer agents. ]]> <![CDATA[ICRISAT to lead the way in recycling wastewater ]]> https://biospectrumindia.com/news/95/6754/icrisat-to-lead-the-way-in-recycling-wastewater-.html https://biospectrumindia.com/news/95/6754/icrisat-to-lead-the-way-in-recycling-wastewater-.html Wed, 30 Jan 2013 13:24:00 +0530 Aiming to address issues of water scarcity, poverty and food insecurity through wastewater reuse for agriculture, the International Crops Research Institute for the Semi-Arid Tropics (ICRISAT) headquartered in Hyderabad, is now leading a consortium of national partners in the project also referred to as 'Water4Crops-India'. It was recently launched in Hyderabad in a kick-off meeting. The initiative is a mirror of EU's Water4Crops project composed of 21 consortium partners led by the Istituto di Ricerca Sulle Acque - Consiglio Nazionale delle Ricerche (IRSA-CNR), Department of Bari, Italy. ICRISAT's Director General William Dar says, "Water reuse is of critical importance to the semi-arid regions of the world. We will now lead the Indian consortium in venturing into recycling industrial and domestic wastewater for agricultural use to improve the livelihoods of the rural poor particularly those in the country's dryland areas." Under the Water4Crops-India project, ICRISAT along with its consortium partners will be embarking on recycling of treated wastewater (grey water) from domestic uses and industrial wastewater. Among the Indian consortium partners are: The Energy Research Institute (TERI); National Environmental Engineering Research Institute (NEERI); Euro India Research Centre (EIRC), University of Agricultural Sciences Bangalore (UASB); University of Agricultural Sciences Dharwad (UASD); MS Swaminathan Research Foundation (MSSRF); SABMiller, India; and Jain Irrigation Systems Limited (JISL). The consortium will be working on three types of industrial waste water mainly from the Charminar Breweries of SABMiller, India in Andhra Pradesh; the Onion and Fruit Processing Plant at JISL, Jalgaon in Maharashtra; and the Sugar Factory from Ugar Sugar in Karnataka.Treatment of domestic wastewater will be studied and used in Hyderabad, Andhra Pradesh; Kolar, Karnataka; and Nagpur, Maharashtra; and saline wastewater from industries in the coastal regions. The consortium will also address the issue of rehabilitating degraded lands using untreated wastewater at certain sites to be identified. The consortium is unique as national and international research organizations and universities have joined hands with private entrepreneurs to find a win-win solution to wastewater disposal using bio-treatments for reuse in agriculture. The project is led in India by Dr Suhas P Wani, Assistant Research Program Director, Resilient Dryland Systems, ICRISAT and in Europe by Dr. Antonio Lopez, Head of Unit, National Research Council, Water Research Institute, Italy. Ten scientists from Europe are participating in this kick-off workshop. ]]> <![CDATA[OSDD to tap cheminformatics for novel drugs]]> https://biospectrumindia.com/news/95/1580/osdd-to-tap-cheminformatics-for-novel-drugs.html https://biospectrumindia.com/news/95/1580/osdd-to-tap-cheminformatics-for-novel-drugs.html Wed, 30 Jan 2013 10:28:00 +0530 In pursuit of common aims and to raise awareness of the importance of Cheminformatics to accelerate the discovery of novel therapies for neglected diseases like tuberculosis (TB) and malaria, the Council of Scientific and Industrial Research (CSIR), on January 29, 2013, signed a memorandum of understanding (MoU) between its Open Source Drug Discovery (OSDD) initiative and the Royal Society of Chemistry (RSC), the largest European organization for advancing chemical sciences in its headquarter here in New Delhi. The MoU, spanning three years, aims to address the objective of finding novel, faster-acting, and more effective regimens for TB and Malaria by advancing the discipline of Cheminformatics. The collaboration envisions conducting workshops and conferences to build links between experts and leaders in the coming years and will focus on jointly building an online repository of real and virtual molecular structures along with developing free-to -use software tools for drug discovery and development. The partnership also aims at exploring the possibility of advancing OSDD's e-learning program for students. Speaking on the occasion, union minister for science and technology, S Jaipal Reddy, said: "The RSC has undoubted strength in the field of chemistry. This strength will now be coupled with the strengths of the OSDD programme, deployed to improve the innovation for neglected diseases." Reddy also stressed the importance of scientific institutions to work towards finding solutions for problems that predominantly affect the poorer sections of the society, like the need for new drugs for Tuberculosis, Malaria and Kala-Azar (Leishmaniasis). Prof. Samir K Brahmachari, director general, CSIR and chief mentor OSDD, also underlined the importance of this collaboration for finding new drugs for neglected diseases like tuberculosis (TB). He said "What we cannot do alone, we with complementary skills, need to work together. Finding new drugs for TB is a major challenge. We are joining hands to find New Chemical Entities which could be potential anti-TB drugs." The RSC's immediate past president, David Phillips, who was in India to announce the MoU said: "Through this agreement, the CSIR and RSC are responding to the challenge of 'lost data' - that is the 90% of research output that never gets published.He said "That data, that information, that knowledge, is lost to society. But it has enormous value to the chemical science research community and by using new tools and new disciplines, like Cheminformatics or e-Science, we can recapture that lost information. The importance of Cheminformatics in addressing this challenge cannot be underestimated." ]]> <![CDATA[Bangalore INDIA BIO 2013 to foucs on " Biotech for better tommorrow" ]]> https://biospectrumindia.com/news/95/3074/bangalore-india-bio-2013-to-foucs-on-biotech-for-better-tommorrow-.html https://biospectrumindia.com/news/95/3074/bangalore-india-bio-2013-to-foucs-on-biotech-for-better-tommorrow-.html Tue, 29 Jan 2013 17:49:00 +0530 The 13th edition of Bangalore INDIA BIO, India's premier Biotech forum will witness a gathering of over 800 delegates, renowned speakers from India and abroad and over 100 exhibitors from the best of industry, research organizations, academia, etc. The three-day event starting from February 4 at The Lalit Ashok in Bangalore on the theme " Biotech for better tomorrow" features a robust programme including multi-track conference, CEO Conclave, panel discussions, workshops, international tradeshow and poster exhibition, and Bio Excellence Awards. The event will have a participation of international delegations from over 20 countries including Scotland, USA (Georgia), Canada (Alberta) and Australia (Victoria) and also from Atlanta, Missouri from USA, Germany, UAE, France, UK, Mexico, Japan, Malaysia and Singapore and European and South East Asia countries, which will give a boost to cross-border partnerships. International MoU's, Technical Tie-ups and Business collaborations agreements will be signed during the event between International Participants and the Indian Life Science fraternity. Dr Kiran Mazumdar Shaw, Chairperson, Karnataka Vision Group on Biotechnology; Chairman and Managing Director, Biocon said," Prof K. Vijay Raghavan, who has taken charge as Secretary, Department of Biotechnology, Ministry of Science and Technology, Government of India on January 28 from his previous role as director of National Centre for Biological Sciences (NCBS) in Bangalore will be sharing ideas in his maiden speech with the biotech community at Bangalore INDIA BIO." Prof Charles ffrench-Constant, Director, Centre of Regenerative Medicine, University of Edinburgh, Scotland, Charles French, Prof Samir K. Brahmachari, Secretary, Department of Scientific & Industrial Research (DSIR), Government of India; Director General Council of Scientific & Industrial Research (CSIR), Prof Anil K. Gupta, Executive Vice Chairperson, National Innovation Foundation - India, Professor of Indian Institute of Management (IIMA), Prof David Koelle, Professor of Medicine, Adjunct Professor, Global Health and Laboratory Medicine, University of Washington; Affiliate Investigator, Fred Hutchinson Cancer Research Center; Affiliate investigator, Benaroya Research Institute,USA will be making key note address at the event. One of the highlight sessions at Bangalore INDIA BIO is The Fireside Chat - a high-profile discussion bringing together a strong line-up of Speakers from leading life sciences companies like Biocon, Bio Century - USA, Novartis India Limited to discuss "India's challenges in being preferred as the Global Biotech Hub". CEO Conclave focusing on theme "Can India become a 100 Billion Dollar Biotech Hub by 2025? "will bring industry leaders from the Life Sciences sector like Dr Kiran Mazumdar Shaw, Chairperson, Karnataka Vision Group on Biotechnology; Chairman & Managing Director, Biocon; Dr Vijay Chandru, Chairman and CEO, Strand Life Sciences; Mr Shrikumar Suryanarayan, Chairman and Co-founder, Sea6 Energy; Honorary Director-General, ABLE; Dr Sudhir Nambiar, Managing Director, AstraZeneca India; Mr Anil Raghavan, Managing Director, Quintiles India; Dr Pradeep Ramayya, Co-founder & CEO, AxSys Technology, Scotland; Ms Deepanwita Chattopadhyay, Managing Director and CEO, IKP Knowledge Park; Dr Ajith V. Kamath, Head, Strategic Research Partnerships, India; External R&D Innovation, Worldwide Research & Development, Pfizer Inc. The International Conference will include focused tracks on key topics like Biosimilars, Regenerative Medicine, Molecular Biotechnology and Bio Informatics, Vaccines and Clinical Research as well as Partnering and Deal Making Trends in Biotechnology. The event serves as the perfect platform for exchange of Knowledge, Business and Partnering. ]]> <![CDATA[BioAsia 2013 attracts over 500 delegates ]]> https://biospectrumindia.com/news/95/3073/bioasia-2013-attracts-over-500-delegates-.html https://biospectrumindia.com/news/95/3073/bioasia-2013-attracts-over-500-delegates-.html Tue, 29 Jan 2013 16:50:00 +0530 The 10th edition of BioAsia, Asia's biggest technology and bio-business platform, attracted over 500 delegates including regulators, from close to 50 countries. Taking place at the Hyderabad International Convention Centre (HICC), Hyderabad from January 28-30, 2013, this much-awaited and most comprehensive life sciences dynamic global forum with "Biologics and Biosimilars" as the theme of the year has Spain as the Country Partner and GVK Biosciences as the principal industry host sponsor. BioAsia 2013 has joined hands with Victoria (Australia), which is the International State Partner for the event this year. Mr N Kiran Kumar Reddy, Chief Minister of Andhra Pradesh, in his inaugural address said, "With dedication to innovation and research, Asia is progressing rapidly towards establishing itself as a major hub of biotechnology. Biotechnology industry is at the threshold of tremendous growth and India is swiftly emerging as an important player in the sector globally ". In a special address, Ms Carmen Vela Olmo, Minister of State - Research, Development & Innovation, Government of Spain said , "For Spain, participating in this well established forum focusing on biotechnology has been considered a priority in order to give continuity to our joint bilateral efforts with our Indian counterparts. The Spanish delegation comprising of leading research institutes, companies and technology centers has firm interest in India at the forefront in diverse fields of biotechnology and its applications and we are confident that BioAsia will offer a great networking platform to all the participants". Dr M K Bhan, former secretary, Department of Biotechnology, Government of India and Pfizer Inc, were awarded the Genome Valley Excellence Awards for their contribution not just to the industry but to the global society at large. Dr Freda C. Lewis-Hall, Executive Vice President, Chief Medical Officer - Pfizer Inc. on receiving the BioAsia Innovation Award said, "Pfizer is continuously innovating to investing in its R&D to develop products that are effective, affordable and meet the highest quality standards. BioAsia has emerged as an important platform for the industry to learn and grow from each other's experiences helping change the face and future of healthcare around the world. It gives us immense pleasure to receive the innovation award - an area that is always our focus". Mr Shakthi Nagappan, CEO, 'BioAsia' said, "We are overwhelmed to witness such an enthusiastic participation. The discussions, debates, developments and decisions during these three days will help in the driving the growth of Biotech & Lifesciences sector. These will also play a significant role in understanding and tapping the multi-billion dollar potential of Biosimilars & Biologics for the benefit of the healthcare industry". The BioAsia2013 has grown manifolds and enhanced its reach across the world by attracting the top officials from biopharma, biotech and health regulatory agencies from 15 countries including prominent names like US, UK, South Africa, Sweden, Czech Republic, South Korea, Malaysia, Jordan, Republic of Lithuania, Ghana, Sri Lanka, Philippines to name a few. The 10th edition of the event has received good response from the industry with Natco, Lonza, Mayar Biotech joining as the industry co-host. ]]> <![CDATA[DIA to organize eCTD training workshop ]]> https://biospectrumindia.com/news/95/3052/dia-to-organize-ectd-training-workshop-.html https://biospectrumindia.com/news/95/3052/dia-to-organize-ectd-training-workshop-.html Tue, 29 Jan 2013 11:35:12 +0530 Leading Industry body DIA (Drug Information Association is organizing a day long eCTD training workshop for pharma professionals on February 4 in Mumbai. This workshop is focused on enabling the participants to compile, publish and validate eCTD submissions with insights on Life Cycle Management and STF compilations. Hands-on training will enable participants to understand regional differences and global submission strategies. Compilation of US M1 and EU M1 will be discussed in detail to empower users with updated information on these major ICH regions. This course is designed for anyone pursuing or intending to pursue Regulatory Affairs, Regulatory Operations, Submissions Management and Electronic Publishing. An interactive presentation will be also given by LORENZ Life Sciences' Professional Services Director, Kent Briggs, who will highlight the latest eCTD activities on a global scale. Attendees will also consider the impact of regional interpretations of eCTD specifications and guidelines on global submissions strategy. ]]> <![CDATA[Dr Gyanendra Shukla is new Managing Director at Monsanto India ]]> https://biospectrumindia.com/news/95/8435/dr-gyanendra-shukla-is-new-managing-director-at-monsanto-india-.html https://biospectrumindia.com/news/95/8435/dr-gyanendra-shukla-is-new-managing-director-at-monsanto-india-.html Mon, 28 Jan 2013 18:01:31 +0530 Monsanto India announced the appointment of Dr Gyanendra Shukla as Managing Director of the Company effective March 1, 2013. He will be replacing Mr Amitabh Jaipuria. A 24-year agriculture sector veteran, Dr Shukla has served successfully in varied roles of increasing responsibility spanning Technology Development, Regulatory, Sales & Customer Service, Sustainability and Corporate Affairs across the India and Asia-Pacific regions and was also Country Manager of the Monsanto Company's business in Indonesia. Prior to joining Monsanto, Dr Shukla worked in Ciba-Geigy (now Syngenta) and Hoechst (now Bayer CropScience) in Technology Development roles focusing on development of insecticides, fungicides and herbicides. Dr Shukla was named 'Fellow of Indian Society of Weed Science' in recognition for his contributions to farmers and the industry, among receiving numerous other external and internal recognitions. He also represents the Company to the National Seed Association of India (NSAI), Association of Biotech-Led Enterprises - Agriculture Group (ABLE-AG), and industry chambers. Dr Shukla holds a Bachelor's degree in agriculture and animal husbandry from G. B Pant University of Agriculture and Technology, a Ph.D. in Agriculture Botany from Kanpur University, and an MBA from S.P. Jain Institute of Management & Research in Mumbai. Mr Jaipuria had joined Monsanto India Ltd (MIL) in November 2007 and over the past five years, he is credited with the significant growth of the herbicide business, steering the corn business through a period of transition, relentlessly focusing on costs, creating industry-leading customer connect platforms, and for having helped nurture and build a strong talent pipeline. ]]> <![CDATA[NDRI scales new peak in stem cell cloning]]> https://biospectrumindia.com/news/95/3056/ndri-scales-new-peak-in-stem-cell-cloning.html https://biospectrumindia.com/news/95/3056/ndri-scales-new-peak-in-stem-cell-cloning.html Mon, 28 Jan 2013 16:29:00 +0530 In yet another example of its growing clout in stem cell research for dairy technology, the researchers at the National Dairy Research Institute (NDRI) have successfully made possible the birth of a female calf from already cloned buffalo. NDRI has named the newborn female calf "Mahima".The Karnal based institute came in lime light earlier on August 22, 2010 for production of world's first buffalo cloned calf 'Garima'. In the world, it is the first calf born from cloned buffaloes, produced through hand guided cloning technique. Mahima, weighing 32 kg, was born on January 25, 2013 at 1.51 PM by normal parturition. The newborn "Mahima" is keeping very good health and have started suckling of milk within 30 minutes of birth. This institute is continuing this frontier technique for producing more cloned animals. Born as a major achievement of the National Agricultural Innovation Project (NAIP) funded sub-project #4137, entitled, "Characterisation and Differentiation of Embryonic and Spermatogonial Stem Cells in Cattle and Buffaloes" attained early sexual maturity at 19 months of age compared to her contemporaries (around 28 months) and was inseminated with frozen-thawed semen of a progeny tested bull of NDRI No. 1875 on March 27, 2012, which resulted in conception. The consortium investigators team is maintaining four embryonic stem cell lines of buffalo already developed and characterized by them for the long term; and is further engaged in developing spermatoginial stem cell line with NAIP support. This research has bearing on conservation of the species as well as its reproduction in eventualities. ]]> <![CDATA[GSK, Biological E initiate JV for hexavalent vaccine]]> https://biospectrumindia.com/news/95/3055/gsk-biological-e-initiate-jv-for-hexavalent-vaccine.html https://biospectrumindia.com/news/95/3055/gsk-biological-e-initiate-jv-for-hexavalent-vaccine.html Mon, 28 Jan 2013 16:18:46 +0530 GlaxoSmithKline (GSK) and Biological E, a leading Indian vaccines company, have announced an agreement to form a 50- 50 joint venture (JV) for the early stage research and development of a six-in-one combination paediatric vaccine to help protect children in India and other developing countries from polio and other infectious diseases. The partnership reinforces the commitment of both companies to support the World Health Organisation's (WHO) global polio eradication programme. Despite a number of collaborations between Indian companies and multinationals in drug discovery research, this would be one of the first in the vaccines space in recent times.Biological E was in the news recently for being the first Indian company to launch an indigenously developed Japanese Encephalitis vaccine last year. If approved, the vaccine, which would combine GSK's injectable polio vaccine (IPV) and Biological E's pentavalent vaccine for diphtheria, tetanus, whooping cough (whole cell pertussis), hepatitis B, and Haemophilus influenzae type b, could be the first of its kind. The vaccine would enable fewer injections for children thereby improving compliance in immunisation schedules. The fully liquid formulation of the vaccine also means it would be ready to use with no additional ingredients or materials required, freeing up space at local storage facilities. The JV will bear the development costs for the candidate vaccine, which is expected to enter phase 1 development in the next two years. A very small initial cash investment will be made by both companies to cover start-up costs for the JV and subsequent development costs will be split equally. Christophe Weber, President of GSK Vaccines said, "We are delighted to be working with Biological E, an established company in the global vaccine market. This agreement is fully aligned to GSK's vision of providing high quality vaccines to those in need and by leveraging Biological E's strengths, this particular vaccine has the potential to play a significant role in the fight against polio." Vijay Kumar Datla, Chairman Biological E said, "We are excited to be working with GSK, and this relationship is a validation of the investments we have made in vaccine technology and quality. We expect to leverage this partnership to accelerate the development of the hexavalent vaccine and make IPV accessible for developing countries in the post eradication phase for polio. We hope to continue playing our part in support of the public health community." Completion of the transaction is expected in 2013, subject to several conditions including regulatory approval of the JV. ]]> <![CDATA[Myko Tech develops process to produce water soluble melanin]]> https://biospectrumindia.com/news/95/5083/myko-tech-develops-process-to-produce-water-soluble-melanin.html https://biospectrumindia.com/news/95/5083/myko-tech-develops-process-to-produce-water-soluble-melanin.html Mon, 28 Jan 2013 15:45:00 +0530 Goa based Myko Tech, having a large culture collection of microorganisms with the aim of exploring for nutraceuticals, pharmaceuticals and enzymes to improve human health and environment, has developed a process to produce water soluble melanin from a fungus and has filed a patent for the technology. Myko Tech has been collaborating with the Bhabha Atomic Research Centre (BARC), Mumbai to study the effect of its melanin in protection against gamma radiation. Dr S. Raghu Kumar, Managing Director, Myko Tech said, " There is presently great interest in studying melanin pigment for its gamma radiation protective properties. And our research findings have been published recently (Toxicology and Applied Pharmacology 264 (2012) 202-211). And these exciting studies indicate that when mice were exposed to 7 Gy of whole body gamma radiation, Myko Tech's melanin provided substantive prophylactic and mitigative activities at a dose of 50 mg/kg body weight." The melanin inhibited radiation-induced hematopoietic damages and reversed radiation-induced decrease in ERK phosphorylation in splenic tissue. The melanin further prevented apotosis in splenic tissue and increased the expression of proliferation markers. Myko Tech' melanin also reduced the oxidative stress in hepatic tissue and abrogated immune balance. Dr Raghu Kumar, further said, " These results show that Myko Tech's melanin is a very effective radio protector. Myko Tech's process provides a natural, human hair-like melanin from a microbial source in large amounts at highly economic yields. While further research is needed to put melanin into actual use for gamma radiation protection, the present study of BARC and Myko Tech show great potentials. " Myko Tech, which is an ideal partner for screening highly diverse fungi and bacteria for a wide range of biotechnological applications, has couple of firms such as Sea6 Energy, Chennai and Sigma-Aldrich, Bangalore as its customers. MykoTech's team has discovered several fungi new to science from the Western Ghats forests of India. These findings have been reported in two papers published in the International Journal Mycotaxon. Such fungi are potential sources of novel metabolites. ]]> <![CDATA[India takes lead in decoding 'Kabuli Channa' ]]> https://biospectrumindia.com/news/95/3050/india-takes-lead-in-decoding-kabuli-channa-.html https://biospectrumindia.com/news/95/3050/india-takes-lead-in-decoding-kabuli-channa-.html Mon, 28 Jan 2013 15:15:00 +0530 The sequencing of the 90 chick pea genomes that was published online on 27 January 2013 in Nature Biotechnology, is widely seen as a step towards improved grain yields and quality, greater drought tolerance and disease resistance, and enhanced genetic diversity. The findings in highest ranked biotech journal, featured the reference genome of the CDC Frontier chickpea variety (a kabuli variety) and genome sequence of ninety cultivated and wild genotypes from ten different countries, as an online publication. The research milestone was the result of years of genome analysis by the International Chickpea Genome Sequencing Consortium (ICGSC) led by the International Crops Research Institute for the Semi-Arid Tropics (ICRISAT) headquartered in Hyderabad, Andhra Pradesh India, involving 49 scientists from 23 organizations in ten countries. The informtion was revealed to media at New Delhi on January 28, 2013 by Dr William Dar, director general, International Crops Research Institute for the Semi-Arid Tropics (ICRISAT). Dr Dar told mediapersons that all the partners have played an equally important role and have once again demonstrated the power of productive partnerships by achieving this breakthrough in legume genomics." On being asked about the long term impact of the findings on farmers, Dr Dar told BioSpectrum, "The sequencing will play a crucial role in speeding up the development of improved varieties for smallholder farmer crops such as chickpea.We are also looking at taking up similar initiatives for the neglected crops grown by the marginal farmers." Dr Rajeev Varshney, coordinator of ICGSC and director - center of excellence in genomics, ICRISAT who led the efforts from Indian side, explained,"Genetic diversity, an important prerequisite for crop improvement, is very limited and has been a serious constraint for chickpea improvement. This study will provide not only access to 'good genes' to speed up breeding, but also to genomic regions that will bring genetic diversity back from landraces or wild species to breeding lines." The global research partnership succeeded in identifying an estimated 28,269 genes of chickpea after sequencing CDC Frontier, a kabuli (large-seeded) chickpea variety. Re-sequencing of additional 90 genotypes provided millions of genetic markers and low diversity genome regions that may be used in the development of superior varieties with enhanced drought tolerance and disease resistance. The findings can be useful to crop improvement for sustainable and resilient food production toward improved livelihoods of smallholder farmers particularly in marginal environments of Asia and sub-Saharan Africa. The Bill and Melinda Gates Foundation (BMGF) also played a key role in funding the initiative. According to Dr David Bergvinson, Senior Programme Manager, Science & Technology, Global Development, BMGF, "Making the chickpea genome available to the global research community is an important milestone in bringing chickpea improvement into the 21st century to address nutritional security of the poor - especially the rural poor in South Asia. We look forward to seeing how researchers around the globe will harness this resource to increase chickpea productivity against the backdrop of climate change in the developing world." ICRISAT in its release noted that the renowned agricultural scientist and member of Indian parliament, Prof MS Swaminathan has appreciated and congratulated its team for the breakthrough. It quoted Dr Swaminathan as saying that chickpea occupied a pride of place in the struggle against protein hunger. "I am confident that the knowledge provided by this study will help accelerate the improvement of this crop through marker-assisted breeding," mentioned Dr Swaminathan. Recognizing the efforts of the global research team, Mr Ashish Bahuguna, secretary, ministry of agriculture, government of India says, "Decoding of the chickpea genome would facilitate the development of improved varieties with higher yields and greater tolerance to biotic and abiotic stresses. This would help chickpea farmers to increase productivity, reduce cost of inputs and realize higher incomes." Dr Swapan Datta, deputy director general - crop science, Indian Council of Agricultural Research (ICAR), highlighted the importance of the breakthrough to India. "The chickpea genome sequence is expected to help in the development of superior varieties with enhanced tolerance to drought and resistance to several biotic stresses. India will benefit most from this genome sequence, our country being the largest producer of chickpea. This, in my opinion, is by far the most significant collaboration between ICAR, ICRISAT and the global genomics community." The highly nutritious, drought-tolerant chickpea contributes to income generation and improved livelihoods of smallholder farmers in African countries like Ethiopia, Tanzania and Kenya, and is crucial to the food security in India (being the largest producer, consumer and importer of the crop). Chickpea is also an important component of the pulse industry in Australia, Canada and USA. As per the press release issued by ICRISAT, the renowned agricultural scientist and member of Indian parliament, Prof MS Swaminathan has appreciated and congratulated its team for the breakithrough. It quoted Dr Swaminathan as saying that chickpea occupied a pride of place in the struggle against protein hunger. "I am confident that the knowledge provided by this study will help accelerate the improvement of this crop through marker-assisted breeding" mentioned Dr Swaminathan. Recognizing the efforts of the global research team, Mr Ashish Bahuguna, secretary, ministry of agriculture, government of India says, "Decoding of the chickpea genome would facilitate the development of improved varieties with higher yields and greater tolerance to biotic and abiotic stresses. This would help chickpea farmers to increase productivity, reduce cost of inputs and realize higher incomes." Dr Swapan Datta, deputy director general - crop science, Indian Council of Agricultural Research (ICAR), who was present at the press conference, highlighted the importance of the breakthrough to India. "The chickpea genome sequence is expected to help in the development of superior varieties with enhanced tolerance to drought and resistance to several biotic stresses. India will benefit most from this genome sequence, our country being the largest producer of chickpea. This, in my opinion, is by far the most significant collaboration between ICAR, ICRISAT and the global genomics community." The initiative was funded by the CGIAR Generation Challenge Programme (GCP), US National Science Foundation (NSF), Saskatchewan Pulse Growers (Canada), Grains Resource Development Corporation (Australia), Indo-German Science Technology Corporation (Germany and India), National Institute for Agricultural and Food Research and Technology (Spain), National Research Initiative of US Department of Agriculture's National Institute of Food and Agriculture (USA), Ministry of Education, Youth and Sports of the Czech Republic and the European Regional Development Fund, University of Cordoba, ICAR (India), BGI (China) and ICRISAT. Chickpea is the second largest cultivated grain food legume in the world, grown in about 11.5 million hectares mostly by resource poor farmers in the semi-arid tropics. The highly nutritious, drought-tolerant chickpea contributes to income generation and improved livelihoods of smallholder farmers in African countries like Ethiopia, Tanzania and Kenya, and is crucial to the food security in India (being the largest producer, consumer and importer of the crop). Chickpea is also an important component of the pulse industry in Australia, Canada and USA. ]]> <![CDATA[Pfizer's Prevnar13 receives FDA approval ]]> https://biospectrumindia.com/news/95/3049/pfizers-prevnar13-receives-fda-approval-.html https://biospectrumindia.com/news/95/3049/pfizers-prevnar13-receives-fda-approval-.html Mon, 28 Jan 2013 14:25:25 +0530 Pfizer has announced that the U.S. Food and Drug Administration (FDA) has granted approval for the expansion of the company's pneumococcal conjugate vaccine, Prevnar 13 (Pneumococcal 13-valent Conjugate Vaccine [Diphtheria CRM197 Protein]), for use in older children and adolescents aged 6 years through 17 years. It states its use for active immunization for the prevention of invasive disease caused by the 13 Streptococcus pneumoniae serotypes contained in the vaccine. For this age group, Prevnar 13 is administered as a one-time dose to patients who have never received Prevnar 13. The vaccine was earlier approved for the age group of 6 weeks through 5 years of age. Prevnar 13 was first introduced for use in infants and young children in December 2009 in Europe and in February 2010 in the U.S. and it is now approved for such use in nearly 120 countries worldwide. It is the most widely used pneumococcal conjugate vaccine in the world, and more than 500 million doses of Prevnar/Prevnar 13 have been distributed worldwide. Currently, Prevnar 13 is included as part of a national or regional immunization program in more than 60 countries, offering coverage against invasive pneumococcal disease to nearly 30 million children per year. Ms Susan Silbermann, president, vaccines, Pfizer has said,"As a global leader in pneumococcal disease prevention, extending the impact of Prevnar 13 to older children and adolescents aged 6 through 17 years is a reflection of our dedication to improving public health worldwide. We continue to work tirelessly to make this vaccine available to people at risk for invasive pneumococcal disease." The FDA approval followed submission and review of a Phase 3, open-label trial of Prevnar 13 in 592 older children and adolescents, including those with asthma.2 The study met all endpoints, demonstrating immunogenicity and establishing a safety profile in children aged 6 years through 17 years consistent with the safety profile established in previous trials in infants and young children. Prevnar 13 is also approved for use in adults 50 years of age and older in more than 80 countries and it is the first and only pneumococcal vaccine to be granted World Health Organization prequalification in the adult population. ]]> <![CDATA[Bhan, VijayRaghavan get Padma Awards]]> https://biospectrumindia.com/news/95/4504/bhan-vijayraghavan-get-padma-awards.html https://biospectrumindia.com/news/95/4504/bhan-vijayraghavan-get-padma-awards.html Fri, 25 Jan 2013 22:56:00 +0530 The nation has chosen to honor the former Secretary, Department of Biotechnology, Dr M K Bhan and his successor, Prof K VijayRaghavan, who will take charge on January 28, 2013, with Padma Awards. Another geneticist, Dr Jayaraman Gowrishankar, from Hyderabad too gets the Padma Shri awards for 2013."It is a great recognition as the government is honouring many scientists ( Prof Yashpal, Prof Ajay Sood and Prof Roddam Narasimha among others) this year. Personally, I am very happy about the award as it is a recognition to the great work being done by my colleagues at the National Centre for Biological Sciences(NCBS), " Dr VijayRaghavan told BioSpectrum in an exclusive comments after the awards list was announced.Dr Bhan will get the Padma Bhushan award while Prof VijayRaghavan will be conferred the Padma Shri awards. Dr Gowrishankar is currently the director of Hyderabad-based Centre for DNA Fingerprinting and Development.Their names figure in the list of 108 awardee names announced by the government on January 25, on the eve of Republic Day.Dr Bhan, a pediatric surgeon and researcher, had relinquished office as Secretary, DBT, on November 30,2012 after an 8-year stint during which he piloted the formation of India's national biotech policy, revamped the regulatory systems to approve biotech products and initiated several path-breaking steps to promote the growth of biotechnology industry and also launched new biotech translational research centres across the country.Prof VijayRaghavan is an internationally known geneticists and molecular biologists and is currently the director of Bangalore-based National Centre for Biological Sciences (NCBS). He will move to Delhi as Secretary, DBT next week.Dr Gowrishankar studied medicine at the Vellore Medical College and later took up full time research and has played a key role in the development of DNA Fingerprinting technology during his tenure at the Centre for Cellular and Molecular Biology(CCMB), Hyderabad. Later he moved to the newly set up CDFD to promote applications of the technology.The Padma awards will be conferred on the recipients by the President of India in March-April, 2013. ]]> <![CDATA[ICAR looks on technology transfers in big way ]]> https://biospectrumindia.com/news/95/2981/icar-looks-on-technology-transfers-in-big-way-.html https://biospectrumindia.com/news/95/2981/icar-looks-on-technology-transfers-in-big-way-.html Fri, 25 Jan 2013 15:59:00 +0530 About 43 patent applications were filed and two international and nine national patents were granted during 2011-12 to the institutes under the Indian Council of Agricultural Research (ICAR). Apart from that over 200 extant varieties were registered and granted protection and 400 and 36 applications were brought out in the Plant Variety Journal. Six copyrights were registered by the ICAR institutes to protect developed softwares. 'Weather Cock' software package, capable of agro-meteorological analysis to understand possible impacts of climate change on crop performance, was developed and registered. Trademark 'IISR' was granted to the Indian Institute for Spices Research, Kozhikode. Dr S Ayyappan, secretary (Department of Agricultural Research and Education) and Director General, ICAR, revealed this on the role of his organization in revolutionizing agriculture, on eve of 64th republic day. "The unforeseen challenges of Indian agriculture are presenting uncommon opportunities that also seek unconventional approaches to harness the potentials and ICAR team is geared to take it head on. Over a dozen patents were granted signalling internalization of IPR culture in the Council. We surged ahead in developing farmer-friendly technologies, their assessment and refinement. Consultations with all stakeholders marked the year in our review and planning process," said Dr Ayyappan. In the field of bio-technology and genomics, ICAR has played a central role in decoding of rice, potato and tomato genomes as partner of international consortium. Recently, India contributed sequencing of the gene-rich region of the tomato chromosome 5 (tomato has total twelve chromosomes) and provided further support to generate five-fold sequence coverage of the entire tomato genome by Next Generation Sequence (NGS) technology. The genomes of the cultivated tomato and its closest wild relative have been decoded by the Tomato Genome Consortium (TGC), a group of over 300 scientists from 14 countries. ICAR is the apex scientific organization with robust agricultural research system for planning, promotion, execution and coordination of agricultural research and education in the country. ICAR with 99 institutes, 65 Agricultural Universities and 631 Krishi Vigyan Kendras (KVKs) spread across the country constitutes one of the largest national agricultural research systems in the world. ]]> <![CDATA[India, Sweden partner to stimulate innovation ]]> https://biospectrumindia.com/news/95/3495/india-sweden-partner-to-stimulate-innovation-.html https://biospectrumindia.com/news/95/3495/india-sweden-partner-to-stimulate-innovation-.html Fri, 25 Jan 2013 13:07:00 +0530 The Department of Biotechnology, Government of India, the Swedish Governmental Agency for Innovation Systems and the Swedish Research Council (SRC) have joined hands to together promote Indo-Swedish research and innovation cooperation, starting 2013. These agencies have given a joint call inviting Indian and Swedish industry and researchers in both private and public sectors to submit joint project applications for collaborative research and innovation projects. The programme comes under the science and technology agreement, signed between the governments of two nations on December 9, 2005. Aimed at funding four to six projects, the total budget is close to 35 million Swedish krona (SEK) over a period of three years (2013-2016). The project proposals from organizations have been asked to include a public private partnership (PPP) perspective in their application. The cooperative period shall be 18- 36 months in total, counting from start date of the project. The call for applications has opened on January 18, 2013 and the final deadline to submit proposals is April 29, 2013. This joint call is expected to stimulate research and development (R&D) projects in companies and at universities, to long-term development of strong research and innovation environments in a number of broad scientific areas. More effective drugs and vaccines and evidence-based vaccination schemes, targeting diseases such as HIV/AIDS, tuberculosis, malaria and neglected diseases will also be supported. The other major areas that will be covered under the programme are medical diagnostics, innovative food, improving health promotion and disease prevention, medical devices, antimicrobial resistance that includes innovative treatment, diagnostics and preventive strategies. ]]> <![CDATA[Kiran Mazumdar-Shaw joins USP Board of Trustees]]> https://biospectrumindia.com/news/95/1892/kiran-mazumdar-shaw-joins-usp-board-of-trustees.html https://biospectrumindia.com/news/95/1892/kiran-mazumdar-shaw-joins-usp-board-of-trustees.html Fri, 25 Jan 2013 11:34:28 +0530 Ms Kiran Mazumdar-Shaw, Chairman and Managing Director and founder of Biocon India joined the Board of Trustees to the U.S. Pharmacopeial Convention (USP), a scientific, nonprofit, standards-setting organization that advances public health through public standards and related programs that help ensure the quality, safety, and benefit of medicines and foods. A biotechnology entrepreneur and executive with global standing, Ms Shaw will help to guide USP's policies, finances and strategic direction as a member of the Board. In addition to her role on USP's Board of Trustees, Ms Shaw will serve as a member of the USP Biologics Advisory Group. Headquartered in the United States, USP operates facilities with laboratory and customer support operations in Brazil, India and China, with a sales office in Switzerland. "As a businesswoman, public health advocate and philanthropist, Ms Kiran Mazumdar-Shaw has innovated and campaigned tirelessly for affordable medications on behalf of patients in India and worldwide for decades," said Dr. Roger L. Williams, Chief Executive Officer of USP. "We are honored to have her serve on USP's Board of Trustees, where her leadership and expertise will be utilized to help guide the organization as it advances its mission to improve the health of people around the world through public standards and related programs that help ensure the quality, safety, and benefit of medicines and foods." Ms Shaw is the second non-U.S. member of the USP Board of Trustees. The first was Dr. Judith Oulton, who served on the USP Board of Trustees in the 2005-2010 cycle. Ms Shaw is honored in this cycle as being an appointed member of the Board, which is allowed for three distinguished members of the professional community by virtue of changes to USP's By-laws that occurred at the 2010 Convention. The decision to seek Shaw was made by the USP Board's Governance Committee, chaired by Dr. Marilyn Speedie, and endorsed unanimously by the USP Board. Under her stewardship Biocon has evolved into India's largest biotech company committed to innovation and affordability to deliver world class therapeutics to the patients across the globe. A pioneer of the biotechnology industry in India, Ms Shaw, has made her country proud with a globally recognized bio-pharma enterprise-Biocon. ]]> <![CDATA[Biocon registers 23% growth in 9M FY2013]]> https://biospectrumindia.com/news/95/7913/biocon-registers-23-growth-in-9m-fy2013.html https://biospectrumindia.com/news/95/7913/biocon-registers-23-growth-in-9m-fy2013.html Fri, 25 Jan 2013 06:49:00 +0530 India's leading biotechnology company Biocon registered 23 percent growth in its nine-months revenues in FY13. Its total revenues during period stood at â‚¹1,889 crore ($355 million); EBITDA at â‚¹472 crore ($90 million); PAT at â‚¹260 crore ($50 million). chairman and managing director, Dr Kiran Mazumdar-Shaw announcing the financial results for the quarter ending December 31, 2012 said, "Our 9M performance has seen a 23 percent YoY increase in revenues and an 11 percent EBITDA growth. We have performed well across all our business verticals. We continue to gain market share for Biosimilar Insulins in ROW markets which now accounts for a significant part of our business. I am also pleased to announce that we have received approval from the DCGI for our novel Monoclonal antibody, Itolizumab indicated for Psoriasis. This is a significant milestone that enhances the value of this late stage asset." Biocon's performance highlights:9M FY13 Financials------------------Revenue: â‚¹1889 crore ($355 million)EBITDA: â‚¹472 crore ($90 million)PAT: â‚¹331 crore ($62 million)â€¢ Biopharmaceuticals: â‚¹1,406 crore ($ million)â€¢ Contract research: â‚¹391 crore ($ million) Q3 FY13 Highlights-----------------Revenue: â‚¹660 crore ($265 million)EBITDA: â‚¹167 crore ($31 million)PAT: â‚¹92 crore ($17 million)Revenue Breakup: â€¢ Biopharma: â‚¹409 crore ($77 million)â€¢ Research Services: â‚¹140 crore ($26 million)â€¢ Branded Formulations: â‚¹86 crore ($16 million) Product performance highlights------------------------------â€¢ Marketing authorization received from DCGI for Alzumab, a novel anti-CD6 biologic (Itolizumab) indicated for psoriasisâ€¢ Option agreement with Bristol Myers Squibb for the novel oral Insulin program: IN 105â€¢ Phase I trial initiated for BVX 20, a novel Anti CD-20 molecule for Non-Hodgkin's Lymphomaâ€¢ Completed the second part of the EU Phase III trials for biosimilar rh-Insulinâ€¢ Initiated global phase III clinical study for biosimilar Trastuzumab ]]> <![CDATA[Lupin receives FDA approval for Oral contraceptive]]> https://biospectrumindia.com/news/95/6200/lupin-receives-fda-approval-for-oral-contraceptive.html https://biospectrumindia.com/news/95/6200/lupin-receives-fda-approval-for-oral-contraceptive.html Thu, 24 Jan 2013 17:06:43 +0530 Lupin Pharmaceuticals has received final approval for its Levonorgestrel and Ethinyl Estradiol tablets USP,0.1 mg / 0.02 mg from the United States Food and Drugs Administration (US FDA) to market a generic version of Watson Laboratories' Lutera 28 tablets. Lupin is also the fastest growing top 10 generic pharmaceutical players in Japan and South Africa according to IMS. Lupin's Levonorgestrel and Ethinyl Estradiol tablets are a combined oral contraceptive indicated for the prevention of pregnancy in women, who elect to use oral contraceptives as a method of contraception. Lupin will be marketing its generic product shortly. Lutera tablets had annual US sales of approximately $ 103.6 million (IMS MAT Sept 2012 sales).Headquartered in Mumbai, Lupin is an innovation led transnational pharmaceutical company producing and developing a wide range of branded and generic formulations and APIs.Lupin is the 5th largest and fastest growing generics player in the US (5.1% market share by prescriptions, IMS Health) and the 3rd largest Indian pharmaceutical company by sales. ]]> <![CDATA[Klenziod builds Asia's first BSL-IV lab in India ]]> https://biospectrumindia.com/news/95/3491/klenziod-builds-asias-first-bsl-iv-lab-in-india-.html https://biospectrumindia.com/news/95/3491/klenziod-builds-asias-first-bsl-iv-lab-in-india-.html Thu, 24 Jan 2013 16:06:00 +0530 The high end biosafety level-IV laboratory (BSL) facility build at Pune by Klenziod, the U S based industrial water treatment company, has been established by the Indian council for medical research (ICMR) with support from department of science & technology, ministry of science and technology, government of India. The creation of such a facility in India is expected to boost outbreak investigations and research on various viral diseases. The project was completed with contributions from large number of scientists, doctors and officers of the department of health research (DHR), ICMR, DST, director and scientists of national institute of virology (NIV), Pune national and international advisers. A total of 16 new; 14 (BSL)-II and 2 BSL-III laboratories have been so far set up for working on viral diseases and tuberculosis (TB) in the country. Speaking at the inauguration ceremony of the BSL IV Lab in December, 2012, Ghulam Nabi Azad, the union minister for health and family welfare had mentioned that the enhancement in the capabilities of the institution through BSL IV infrastructure is going to be of crucial importance and substantive help to not only India but also to other countries in the region. The NIV, Pune, where the laboratory has been set up, has played a flagship role in investigations of the diseases of national and international concern such as SARS and Avian Influenza, besides the Influenza A H1N1 pandemic. The institute has been known for its tremendous work on research and management of infectious agents including viruses. It continues to do excellent work on viruses which are transmitted by vectors including mosquitoes, ticks and mites. The organizations have done laudable contributions on Hepatitis, Influenza and several other different viruses causing acute Encephalitis Syndrome (AES) in the recent years. ]]> <![CDATA[ABLE to award outstanding biotech players ]]> https://biospectrumindia.com/news/95/1204/able-to-award-outstanding-biotech-players-.html https://biospectrumindia.com/news/95/1204/able-to-award-outstanding-biotech-players-.html Thu, 24 Jan 2013 11:18:00 +0530 The winners of the various awards to be given away by the Association of Biotechnology Led Enterprises (ABLE), will be announced by the end of February and will receive the awards on March 11 at a function to be held in New Delhi. These various important players of the biotechnology industry are expected to get awarded for their outstanding contributions to the growth and development of this sector in India over the period of ten year period from 2002 to 2012. As per the statement from ABLE, there will be ten awards to be given in six categories. In the first category for private companies there are four awards, one each in biopharma, bioagriculture, bioservices and bndustrial sectors. In the two public sector categories, there will be an award for a central government department for having provided leadership and enabling policies for biotech research and support to the biotech industry. Another award in this category, will be for a state that provided the best leadership and support to the biotech Industry. In the financial category, two awards - for VC/PE companies that provided financial support to life science companies at various stages of their growth. Under the education category, the award will be presented to college or universities imparting a high quality life sciences education The last category award for park/incubator, will be for providing facilities for biotech companies especially the start-ups. ]]> <![CDATA[BIRAC launches second phase of BIG scheme ]]> https://biospectrumindia.com/news/95/1191/birac-launches-second-phase-of-big-scheme-.html https://biospectrumindia.com/news/95/1191/birac-launches-second-phase-of-big-scheme-.html Wed, 23 Jan 2013 16:50:00 +0530 The Biotechnology Industry Research Assistance Council (BIRAC), a 'not-for-profit' section 25 company with a vision to stimulate, foster and enhance the strategic research and innovation capabilities of the Indian biotech industry particularly SME's, has launched the second phase of Biotechnology Ignition Grant (BIG) scheme by inviting proposals from the registered biotechnology start-ups incorporated on or after January 01, 2010. The scheme is for high level of innovation in the biotechnology sector and the funding will be in the form of grant-in-aid limited up to â‚¹50 lakh to validate proof-of-concept research. Aimed at enabling the creation of spin-offs, the BIG scheme would help to support and nurture the high risk early starters and their concepts. The scheme is open for potential entrepreneurs from academia, start-ups or an incubatee (researchers, PhDs, medical degree holders, biomedical engineering graduates) who have exciting concepts which may be in the nascent and planning stage. Incubator with such an idea which may be in the nascent and planning stage are also eligible to apply under this scheme. The company should have a functional R&D laboratory and if the company does not have one of its own, then it should be incubated in an Incubator which has a functional laboratory. The period for the study should not exceed 18 months and funding may also be used for conducting limited market research, patenting costs, working capital during the period, travel, and salary. The conditions that come with the submission of proposals include that there will be no hard copy but only online submission. The online proposal for the scheme that has to be submitted on the BIRAC website, started on January 01, 2013, and will be open till February 2013. ]]> <![CDATA[Bioscience knowledge not fully utilized: Dr Nitya Anand]]> https://biospectrumindia.com/news/95/3498/bioscience-knowledge-not-fully-utilized-dr-nitya-anand.html https://biospectrumindia.com/news/95/3498/bioscience-knowledge-not-fully-utilized-dr-nitya-anand.html Tue, 22 Jan 2013 16:30:00 +0530 "It is shameful that despite all the information from surveys and existing knowledge treasure, we have not been able to do much." This was stated by Dr Nitya Anand, former director of Central Drug Research Institute who used strong words to voice his disappointment, while speaking at the Ranbaxy Science Foundation's (RSF) 29th round table conference held at New Delhi on January 22, 2013. "Medical and the bioscience knowledge has so far not been fully utilized. To bridge this gap, all the stakeholders have to play a role. Policy making and implementation in this regard has to be very proactive. The strategy has to be implemented at multiple levels and RSF is trying to bring everybody on the same platform," added Dr Anand, who is a renowned pharmaceutical scientist and currently the chairman of RSF. Dr Anand further cited many reports to explain the fact that, while about 30 percent of the cancers are related to the obesity, 40-50 percent of the cancer can be still prevented if timely preventive measures are taken. However, he expressed his displeasure with the non-implementation of such information in the policy making. The event focused on preventive and promotive health, the non communicable diseases such as cancer, heart diseases, and diabetes. Prominent speakers such as Mr Jagdish Prasad, director general, Health Services, Government of India, Dr Anoop Misra, Fortis C-DOC Center of Excellence for Diabetes, Metabolic Diseases and Endocrinology, New Delhi, Dr Nikhil Tandon, All India Institute of Medical Sciences (AIIMS), and Dr Rajinder K Jalali of RSF, shared their views on the above topics. RSF is a non-profit organization dedicated to promote scientific endeavours in the country by encouraging, rewarding and channeling national and international knowledge and expertise on subjects connected to the treatment of diseases afflicting mankind. ]]> <![CDATA[Alembic Pharma's Q3 net profits up by 9.1%]]> https://biospectrumindia.com/news/95/2978/alembic-pharmas-q3-net-profits-up-by-9-1.html https://biospectrumindia.com/news/95/2978/alembic-pharmas-q3-net-profits-up-by-9-1.html Tue, 22 Jan 2013 13:55:00 +0530 Headquartered at Vadodara in Gujarat, Alembic Pharmaceuticals, a vertically integrated research and development pharmaceutical company that manufactures and markets generic products all over the world, reported growth in net profit by 9.1 percent at â‚¹48.27 crore for the quarter ended December 31, 2012 against â‚¹44.23 crore in corresponding quarter last fiscal. The company posted 12.2 percent growth in profit before tax at â‚¹60.09 crore for the quarter against â‚¹53.54 crore posted in corresponding quarter last fiscal. Alembic posted total revenue of â‚¹372.05 crore for the quarter ended December 31, 2012, compared to â‚¹382.82 crore in the corresponding quarter last year. The domestic formulations business posted sales of â‚¹227.64 crore against â‚¹198.78 crore with a 15 percent growth over the corresponding quarter of the previous year against the backdrop of slowing growth rate of IPM. Alembic maintained market share of 1.76 percent Azithral was ranked 25th and Alembic has three other brands in the list of top 300 brands of industry i.e. 'Althrocin', 'Roxid', and 'Wikoryl'. The chronic and acute segments grew by 23 percent and 4 percent respectively in current year. The company that has launched a dermatology division in current fiscal year, has state of the art brands, which are marketed through a team of over 3600. The international Generic Formulation sales is â‚¹61.05 crore against â‚¹58.45 crore over the corresponding quarter last year. During the quarter six ANDA application was filed taking cumulative ANDA and NDA filings of the company to 55. Cumulative ANDA approvals now stands at 21. ]]> <![CDATA[Apollo to start proton therapy center for cancer treatment ]]> https://biospectrumindia.com/news/95/3500/apollo-to-start-proton-therapy-center-for-cancer-treatment-.html https://biospectrumindia.com/news/95/3500/apollo-to-start-proton-therapy-center-for-cancer-treatment-.html Mon, 21 Jan 2013 17:32:00 +0530 Chennai headquartered Apollo Hospitals has announced its plans to establish a Proton Therapy Center in India, claiming the same to be first of its kind across South East Asia, Africa and Australia. According to the healthcare giant, this launch marked the beginning of the next wave of advancement in radiation therapy in India. The deal worth approximately Rs 400 crore with Belgium based company, IBA (Ion Beam Applications S.A.), a worldwide technology leader in the field of proton therapy, covers the equipment and services including the long-term operation and maintenance of the center. Designed with state-of-the-art technology, IBA Proteus®PLUS is clinically inspired to offer the possibility to configure the most appropriate combination of features to meet the individual needs of patients and provides a versatility to meet the clinical objectives of physicians. IBA will equip the Apollo Proton Therapy Center with its Proteus®PLUS multi-room configuration which will include three treatment rooms with Uniform Scanning and Pencil Beam Scanning capabilities. IBA will also provide all dosimetry equipment to ensure the safest and fastest commissioning of the center so that patients can benefit from this technology starting 2016. In addition to this, the Apollo Proton Therapy Center will have a significant portion of the facility dedicated to research and development that will partner with leading institutions across the world to foster innovation so as to make modern healthcare accessible and available for the nation. Speaking on this new initiative, Dr. Prathap C Reddy, Chairman, Apollo Hospitals Group said, "This new proton therapy facility will give patients access to the most advanced radiation therapy technology. Moreover, the center will become an International Proton Therapy Center of Reference in Asia, allowing us to further enhance our ability to provide superior cancer care and promote the benefits of proton therapy technology across the sub-continent". Olivier Legrain, Chief Executive Officer of IBA, commented: "We are very excited to be making proton therapy available for the first time in India. The Indian healthcare market is growing rapidly and there is a significant need for innovative approaches to cancer therapy. Apollo Hospitals is one of Asia's leading healthcare providers and through our collaboration, IBA further strengthens its world leading position in proton therapy and will be at the forefront of delivering the latest in innovative cancer therapy to the Asia region." A per company statement, with approximately 3 million people suffering from cancer in India and one million new cases being detected every year, there is a need for specialty cancer treatment hospitals. As most patients are diagnosed with advanced stage cancer, the demand for state-of-the-art cancer treatment is high. Apollo has claimed that this Proton Therapy Centre, with its highly advanced technology, will be able to provide the best in class treatment for patients who suffer from cancer. The company claims that Proton therapy is increasingly considered the most advanced and targeted cancer treatment due to its superior dose distribution and fewer side effects. It is used today to treat many cancers and is particularly appropriate in situations where treatment options are limited and conventional radiation therapy presents risks to patients. These situations include eye and brain cancers, tumors close to the brain stem and spinal cord, prostate, liver, lung and breast cancers, and pediatric cancers. ]]> <![CDATA[Indo-Finnish scholars forge discovery partnership]]> https://biospectrumindia.com/news/95/3494/indo-finnish-scholars-forge-discovery-partnership.html https://biospectrumindia.com/news/95/3494/indo-finnish-scholars-forge-discovery-partnership.html Mon, 21 Jan 2013 10:51:00 +0530 Realizing the importance to share ideas and new insights, the department of biotechnology (DBT) and the Academy of Finland will fund synthetic biology research teams in India and Finland respectively. The projects upto the duration of four years can cover topics such as modelling and simulation of biological reactions and systems; synthetic biology: tools and production systems and socio-cultural issues relating to synthetic biology. The submission of application on both sides can be done upto February 6, 2013. Under the agreement, the Indian and Finnish co-applicants will develop one joint research plan that will be sent both to the DBT and Academy of Finland using their respective forms. The applications must include a statement on how the proposed collaboration is expected to bring added valued to both countries. The project budget must clearly delineate justified Indian and Finnish costs. The costs of the Indian partner must be eligible in accordance with the guidelines of the DBT. Accordingly, the costs of the Finnish partner must be eligible in accordance with the guidelines of the Academy of Finland. Applicants have been reminded to include sufficient budget for travel between Finland and India to ensure successful collaboration. The synthetic biology has got tremendous applications and has a greater role to play in the modern research. It involves utilization of engineering principles in the living cells by inserting the man made DNA stretches, leading to the products that have immense value to cure diseases. ]]> <![CDATA[Forecast favorable for BioAgri]]> https://biospectrumindia.com/views/95/2970/forecast-favorable-for-bioagri.html https://biospectrumindia.com/views/95/2970/forecast-favorable-for-bioagri.html Fri, 18 Jan 2013 12:34:47 +0530 The agribiotech sector in India is poised to grow at much faster rate than ever before in 2013 and we hope that the conducive and positive policy environment will boost the growth of the sector. Research collaborations between the public and private sector are essential to ensure the growth of the seed industry and prime minister Dr Manmohan Singh's statement on utilizing the potential of modern biotechnology will provide further impetus to develop technologies that can deliver positive results for farmers. In the times ahead, risks related to water availability and climate change will be the key challenges for the agriculture industry. The adoption of innovative technologies will play a major role in addressing these risks. Mahyco has been growing at a steady rate and expects to continue its growth journey in 2013 as well. As a research-focused company, Mahyco is always working on encouraging investment in research for path breaking solutions to address the critical needs of the Indian farmers. The company also expects to make an announcement regarding its pipeline products in 2013, which are at various stages of development. - Dr Usha Barwale Zehr, chief technology officer, Mahyco Agricultural biotechnology in India is at a crucial juncture. While the traits are being increasingly recognized for their value addition in agriculture and to the country's economy, increasing concerns are aired for an effective regulation being in place to release the traits to environment, and on the general public's awareness that the food and food products produced through genetic modification are safe. Prospects for BioAgri in 2013 is good, while the uncertainties could needlessly delay the harvesting of benefits of biotechnology in Indian agriculture. - Dr MJ Vasudeva Rao, president, Ag technologies, Metahelix Life Sciences ]]> <![CDATA[Outlook promising for BioPharma in 2013 ]]> https://biospectrumindia.com/views/95/2969/outlook-promising-for-biopharma-in-2013-.html https://biospectrumindia.com/views/95/2969/outlook-promising-for-biopharma-in-2013-.html Fri, 18 Jan 2013 11:28:17 +0530 BioPharma industry leaders share their valuable thoughts for the year 2013. I would expect 2013 to be a continuation of some of the trends we started seeing in 2012. In domestic pharma market National List of Essential Medicines (NLEM) will be a significant factor as also a focus by companies on building brands/improved sales force effectiveness. Increased co-marketing and licensing deals in the domestic market [both for prescription (Rx )and over-the-counter (OTC)]. In international generics space, there will be increased focus on value-over-volume for regulated markets and increasing relevance of emerging markets. R&D effectiveness will be crucial. Novel Drug Delivery Systems (NDDS) and niche technologies will continue to be a focus area. With increase in drug development costs, big pharma will return as clients for custom manufacturing and clinical research organizations (CRO). There will be growth in Contract Research and Manufacturing Services (CRAMS). - Mr Ajit Mahadevan, partner, Life Sciences, Business Advisory Services, Ernst & Young Globally, 2013 is a critical year that will indicate the impact of Euro-zone debt and the so-called US "fiscal cliff." Both these events are likely to have two significant impacts on government budgets. First, they are likely to reduce public spending on healthcare [growth of healthcare costs is higher than growth in gross domestic product (GDP) in most the Organization for Economic Co-operation and Development (OECD countries] and increase the pressure for new healthcare products to differentiate and show comparative benefits. Second, the impact on budgets could also reduce government spending on medical research (for example, budgets in premier biomedical research institutes such as the National Institutes of Health in the United States have been relatively flat); this could have a long-lasting impact on innovative biomedical research and ultimately new products and services in healthcare. Indian healthcare, which is different from most OECD countries, is driven primarily by out-of-pocket expenses and private expenditure. In fact, India GDP growth has not been matched by growth in public healthcare spending (a paltry 1.2 percent of GDP); increases have been primarily in out-of-pocket, private spending. High out-of-pocket expenses, a primary reason that causes patients to fall into debt and poverty, are an important political issue both at the national level and in a global forum such as the United Nations. In order to ameliorate this situation, various groups are looking at universal healthcare coverage as critical to improving healthcare outcomes in India. In a recent academic article, some leading researchers have estimated that the cost of such an initiative could be quite affordable at less than $40 per person per year (approx INR1700). Additionally, the government intends to increase public spending up to 2.5 percent of GDP by the end of the 12th plan to increase the available healthcare infrastructure. One of the bills winding its way through the political system is the National Health Bill. In addition to this, the Food Security Act, which could improve nutrition, is also critical to reduce high levels of Indian childhood malnutrition (a key correlate of poor healthcare outcomes). Apart from these, political activities in the field of public health, the new National Vaccine policy is an important document that outlines improved access to vaccines for the Indian public to reach global standards of prevention. An increasing trend in these activities of the government is also the change in its role from being a provider to a payer. If done with the right spirit and intent, one expects these various actions to increase equity in access to healthcare. An important Indian public health success of 2012 has been the lack of incidence of polio for more than a year. This will help the government move from oral polio vaccine to an injectible polio vaccine over the coming years. The polio end-game needs to be worked out carefully with various stakeholders in mind. Shantha Biotech expects to play an important role as an important supplier of this injectible vaccine in this end-game of significant national importance. In 2013, Shantha continues on our long term mission of providing affordable vaccines and medicines to the developing world. We will continue to provide vaccines to Indian government for public health. From an innovation perspective, Shantha continues to focus on simplification of vaccination by focusing on development of multivalent "one-shot" combination vaccines which will increase compliance and reduce programatic costs. Also, in focusing on women's health in a developing country, we are developing a novel, affordable, universal HPV vaccine that could significantly broaden coverage against the dreaded cancer caused by this virus. - Dr Harish Iyer, CEO, Shantha Biotechnics The year ahead holds immense promise for the Indian biotech sector, which is at an inflection point. The industry has leveraged the entrepreneurial spirit to build a strong foundation which has enabled the industry to grow at a CAGR of 20 percent for over a decade, growing to a size of $ 4 billion in 2011.The next year will see innovation taking center stage, driving significant progress in the areas of biosimilars and diagnostics for affordable healthcare, integrated traditional medicine, biomedical informatics, biofuels for less dependence on petroleum, bioremediation for environmental recovery, enhanced agricultural productivity and improved nutritional attributes. BioPharma and the healthcare sector are the largest component of the Indian biotech industry and the most promising. It has the potential to carve out a large portion of the global biosimilars opportunity estimated to assume a size of $ 2.5 billion by 2015. The coming year will see collaborative trends gaining momentum with more co-development and marketing partnerships - between multinationals and the Indian companies as they seek to accelerate their growth by leveraging emerging markets. We will see a surge in both biomanufacturing and bioservices partnerships which will enable innovative solutions for the world coming out of India. The increasing focus on genomics and proteomics in pharmaceutical research augers well for bioinformatics where India can position itself as a key hub of knowledge and expertise. With the excellent foundation, improved infrastructure, good quality talent and enabling regulatory environment, biotech has the potential to be the next technology beacon for the nation. As for Biocon we are truly committed to provide affordable high quality biopharmaceuticals for chronic diseases particularly diabetes, cancer and autoimmune diseases. We are on track to bring our second novel molecule, Itolizumab, an anti CD6 monoclonal antibody, to the market in India next year. For 2013, that will be the most significant achievement for Biocon and a great boon for Indian patients struggling to manage Psoriasis. We will also continue to focus on expanding our Insulin market in several emerging markets in Asia, Middle East North Africa, LATAM and Eastern Europe. - Dr Kiran Mazumdar Shaw, chairperson and managing director, Biocon The outlook for BiopPharma sector for 2013 looks quite promising even though approvals of biologicals were on decline in 2012. The biopharma sector contributes about 60 percent of the Indian biotechnology industry and has witnessed compounded annual growth rate of 21.63 percent which is quite impressive. The vaccine story in which India has become major hub for vaccine manufacturer in the world producing vaccines at affordable cost is proof of capabilities of Indian companies in BioPharma sector. Serum Institute of India is world's no.1 manufacturer of vaccines like tetanus, diphtheria, pertussis, HIB, BCG, hepatitis B, measles, mumps, and rubella. Key focus in the coming year will be enhancing further capacities of the above vaccines for which state-of-the-art plants are under various stages of completion. Development of critical mass in terms of knowledge to further strengthen quality systems is major thrust area in coming years. With robust pipeline of various newer vaccines in offing structured program is carried to reduce the time-to-market. Products on the horizon are many like rota and pnemococcus and HPV vaccines. This in itself is a gigantic task of putting new R&D incubators and going through entire process of germination of idea till commercialization. The acquisition of Bilthoven Biologicals in Netherlands will be used as spring board for the launch of Serum vaccines in developed world. One of major focus areas in years to come will be efforts to make injectable polio vaccine at affordable cost. - Dr SD Ravetkar, executive director, Serum Institute of India The biotechnology industry in India continued to see strong growth in the year 2012; on the strength of biosimilars, in terms of their domestic market growth, exports, product/clinical development, new product launches and product-based partnerships. This trend is expected to strengthen further in the year 2013. At the same time, the industry has had to face several challenges in 2012, particularly with price erosion, greater competition, constraints in capital markets, currency depreciation and more stringent regulations for biotherapeutics. The industry would continue to face these challenges in the year 2013. The biotechnology industry in India has the potential to grow at 20 to 25 percent per annum. This is contingent on a partnership between industry and government, which recognizes opportunities for the Indian biotech industry to be a global leader, particularly in vaccines, biosimilars and regenerative medicine, and institutionalises policies that enable faster market entry at lower costs, without compromising product quality, safety and efficacy. Reliance Life Sciences looks forward to 2013 with expectations of higher growth and profitability, on the basis of the depth of its product pipeline and diversity of its market participation. - Mr KV Subramaniam, president and CEO, Reliance Life Sciences BioSciences industry will continue to grow with more ME-TOO products coming in and jostling for space. More and more companies will go for OTC-like branded products. Merger and acquisition will continue. Innovation will take a back seat as the focus on generating earlier revenues and lack of adequate financing will continue. However, the public-private innovation model will take a positive start as more and more products will be taking root under the BIRAP type opportunities. The CRO model in India is yet to take off. China continues to be the preferred desitination for both clinical and discovery R&D. Large MNCs are shying away from opening up R&D centers in India on alarge scale. The patent regime continues to be an over-riding factor. Even Indian firms like Avesthagen have been rudely surprised by arbitarary decisions made by the Ministry of Commerce and Industry, Government of India on a patent granted by the Indian Patent office for its diabetes product. Flimsy grounds, no discussion with the company on what is called the "rarest of rare" laws. Is this a joke? On one hand the government tries to promote science on traditional medicine and then revokes it when a company actually delivers. It's a shame and will not allow anyone to take risks in R&D in the future. The BioAgri industry stagnates as the focus is only on Bt brinjal or Bt cotton, and always linked to MNCs. This is not the way forward. One needs to bring in and support SMEs and research products to get into the market. Avesthagen will work towards the commercialization of its assets of products and patents in the areas of science and innovation, BioPharma, BioAgri andc BioNutrition world wide through licensing, royalties, spin outs and joint ventures. - Dr Villoo Morawala-Patell, chairperson and managing director, Avesthagen We ranked 134 out of 187 countries in the Human Development Index. We are facing an increase in both chronic diseases such as cancer and diabetes and infectious diseases such as tuberculosis (TB) and malaria. Creating a healthy nation, we need a faster and accurate detection and diagnostic technologies. Going forward, high quality and affordable diagnostics will play a key role in solving many of the healthcare challenges before the nation. - Dr Satya Prakash Dash, consultant BioPharma and diagnostic sector will grow faster than other sectors as the economy is picking up. Many new products will see as the industry is picking up steam. We, at Bhat Bio-Tech, are planning to introduce several products. They include:TB diagnostics based on signature molecules present in the blood of infected people. We have identified several specific molecules and more than 3-4 molecules will indicate the infection. The ELISA-based kits are being tested in several centres, PCR-based molecular diagnostic kits are being developed for several infectious agents and they are also being tested and will be launched this year. We will be launching low-cost PCR machine which will enable to do the molecular diagnostics in mid level diagnostic centres. We will also be launching voltage-dependent PCR amplicon detection system that will not require gels or labels. Similarly, LAMP-based molecular diagnostic kits are also being developed and planned to be released this year. Agriculture-based diagnostic kits are also being developed and we hope to have them ready for launch this year. - Dr Shama Bhat, chairman & managing director, Bhat Bio-Tech India There have been interesting developments in the field of stem cell biology with approvals granted by the US and Canadian FDA for use of stem cells in osteoarthritis and graft versus host disease. Many more difficult to treat indications that have so far not been adequately treated by the existing drugs and biopharmaceuticals are being explored in various clinical trials across the world. Indian stem cell research has seen completion of the Drug Controller General of India (DCGI) approved phase II work on the role of mesenchymal stem cells in certain indications and the inspiring results have paved way for phase II b studies. Once these trials are completed and the results analyzed, stem cells will play a role as alternate/ adjuvant in certain difficult to treat medical conditions. One among the bedside procedures with increasing acceptance and clinical use is platelet rich plasma which is being attempted for various clinical situations requiring growth factors. Literature is abundant on its role both in medical and dental applications and its use in India though not yet legally approved is on the increase. What is required now is for the drug control authorities to be aware of such developments and ensure approvals are not delayed for meaningful research in such areas. Recombinant platelet derived growth factors have already been approved for phase III clinical research in certain conditions and if the results are good will pave the way for India to join the main stream of approving the addition of adult stem cells into the therapeutic armamentarium of physicians open to considering cellular therapies. Based on above, biologicals, biopharmaceuticals and biotechnology will continue to be main stream mechanisms in drug development for the year 2013 and beyond! - Dr Ramananda S Nadig, director, Science and Research, Jnana Sanjeevini Medical Center ReaMetrix looks forward to the year 2013 with a lot of excitement. We expect the formal launch of our hardware platform for research and diagnostics in the market this year. We are working on novel assays for HIV and TB diagnostics that would see the market shortly. With a number of innovation-driven medical diagnostics businesses getting established in India along with the support provided by the government of India through the Council of Scientific and Industrial Research (CSIR), and Department of Biotechnology, we feel that 2013 could be a break-out year for the industry. - Mr Sridhar Ramanathan, executive director, ReaMetrix ]]> <![CDATA[WHO: Dengue is the fastest spreading viral disease]]> https://biospectrumindia.com/news/95/2961/who-dengue-is-the-fastest-spreading-viral-disease.html https://biospectrumindia.com/news/95/2961/who-dengue-is-the-fastest-spreading-viral-disease.html Thu, 17 Jan 2013 18:32:38 +0530 The World Health Organization's second report on neglected tropical diseases which was published recently says that, the renewed momentum has shifted the world closer to eliminating many of the conditions that take their greatest toll among the poor. Thanks to the new global strategy, a regular supply of quality-assured, cost-effective medicines and support from global partners. One of the highlights of the report include the fact that in 2012, dengue ranked as the fastest spreading vector-borne viral disease, with an epidemic potential in the world, registering a 30-fold increase in disease incidence over the past 50 years. The report says that the world needs to change its reactive approach and implement sustainable preventive measures. Support from those countries endemic for these diseases and partners have helped fast-track actions and initiatives that are now having a measurable impact in affected countries and considerable scaling up of preventive chemotherapy. In 2010 alone, 711 million people received treatment for at least one of the four diseases targeted for preventive chemotherapy which include lymphatic filariasis, onchocerciasis, schistosomiasis and soil-transmitted helminthiases. Dr Margaret Chan, director-general of WHO says, "The challenge now is to strengthen capacity of national disease programs in endemic countries and streamline supply chains to get the drugs to the people who need them, when they need them." Over the next five years, WHO projects that the treatment for schistocomiasis (bilharzia) will reach 235 million people. This will be achieved by increasing availability of medicines (praziquantel) using gifts of medicines and improved distribution at country level. Key highlights of the report include the fact that eradication of dracunculiasis is in sight. WHO reports a reduction in the number of reported cases of dracunculiasis to 521 cases between January and September 2012 compared with 1006 confirmed cases for the same period in 2011 and of human African trypanosomiasis (sleeping sickness) to less than 7000 in 2011 from a high of 30 000 annual cases at the turn of the century. Also, Rabies has been eliminated in several countries, and WHO anticipates regional elimination of this preventable disease by 2020. A new strategy involving the early detection and use of antibiotics to treat Buruli ulcer has drastically reduced suffering and disability from this chronic and debilitating skin condition. An evaluation of WHO's new strategy, which aims at eradicating yaws by 2020, using a new oral antibiotic treatment designed to replace those developed in the 1950s and which mainly centered on delivering injections of benzathine benzylpenicillin. ]]> <![CDATA[India starts national registry for stroke patients]]> https://biospectrumindia.com/news/95/6443/india-starts-national-registry-for-stroke-patients.html https://biospectrumindia.com/news/95/6443/india-starts-national-registry-for-stroke-patients.html Thu, 17 Jan 2013 18:19:28 +0530 After the successful compilation of India's national cancer registry, the first-of-its-kind for any disease in the country over the last two decades, the government has embarked on an ambitious project to prepare a national registry for stroke in 2013. The stroke registry program will be spearheaded by Bangalore-based National Centre for Disease Informatics and Research (NCDIR) which is a constituent unit of Delhi-based Indian Council for Medical Research. The National Cancer Registry work started in 1982 and eventually the program led to the formation of NCDIR. The institution has the mandate to prepare national registries for other diseases such as diabetes and coronary vascular disease. Stroke is the second disease tackled by NCDIR. NCDIR's director-in-charge, Dr A Nandakumar, recently kicked off the program inviting all neurologists, radiologists, community and public health professionals and physicians treating stroke patients across the country to register their patients with the institution. Just like the cancer registry, initially the registry will seek to access data from at least top 20 locations in the country. The registry will use information technology tools effectively to capture data about stroke patients from across the country. "The proposal envisages using electronic information technology in collecting information on stroke cases as and when they are reported," wrote Dr Nandakumar in his invitation letter to medical professionals. Initially, the registry will be a national in coverage. Later, if the response is good, there will be compilation even population-based registries for various cities. This has been done in the case of cancer registry. The two-decade long cancer registry program, the forerunner of the exercise on stroke has been a great success in making available valuable data on cancer incidence and trends to help healthcare professional formulate their treatment plans. According to a recent research paper writer by Dr Nandakumar along with Dr Ramnath Takiar and Dr Deenu Nadayil, based on the national cancer registry data collected since 1982, the number of cancer cases in India is projected to increase by 17 percent, from 979,786 patients in 2010 to 1.15 million by 2020. The data is derived from six of the 24 population-based cancer registries. The registries used for the study are from Bangalore, Barshi, Bhopal, Chennai, Delhi and Mumbai. Data from the North East India cancer registry too has been used. Some interesting trends have emerged from the cancer registry. The number of women cancer patients are 20 percent more than men. Tobacco-related cancer cases form the largest chunk in the country, which is about 20 percent of all cases. Cancers of the digestive tract is second in incidence, followed by head and neck cancers, blood-related cancers and gynecological related cancers. Breast cancer is one of the fastest growing segment and the number of cases are predicted to cross the 100,000 mark in the year 2020. What is alarming is the realization that more than 80 percent of the cancers in India are in the advanced stages and palliative care and relief are essential to provide good quality life for these patients. The study has recommended preparation of an essential drug list and equip all public health centres with cancer chemotherapy and related services. ]]> <![CDATA[75 biotech start-ups have presence in Gujarat]]> https://biospectrumindia.com/news/95/2966/75-biotech-start-ups-have-presence-in-gujarat.html https://biospectrumindia.com/news/95/2966/75-biotech-start-ups-have-presence-in-gujarat.html Thu, 17 Jan 2013 17:31:00 +0530 The sixth edition of "Vibrant Gujarat 2013: Global Investor Summit" organized by the government of Gujarat received good response from the biotech industry, as it witnessed a gathering of over 45 companies to the Round Table Meet of biotechnology investors, at the day long meet held on January 11, 2013 at Ahmedabad and was organized by the Gujarat State Biotechnology Mission (GSBTM), a nodal agency for biotechnology, to provide a networking opportunity to biotech industry from Gujarat. Mr Akshay Kumar Saxena, mission director, GSBTM, in his presentation on the status of biotechnology in Gujarat pointed out the achievements of the mission in creating public awareness about the biotechnology applications and support offered to the industry and about building good public-private partnerships between industry and academia. Since the inception of GSBTM in 2004, the government has helped around 75-80 new biotech companies to set up operations in the state, and completed investment of around â‚¹1,600 crore and about â‚¹2,500 crore is till under implementation stage. Besides providing venture support to many 'start-up' companies and technologies, the mission has supported over 700-800 beneficiaries under Entrepreneurship Development Programs. In addition to creating scientific assets worth â‚¹14 crore, around 50 major instruments and 200 minor instruments (worth â‚¹8 crore at GSBTM centre and â‚¹6 crore at different university departments/colleges), the mission has established 3-4 science based institutes/centres. Through these initiatives, the mission was able to support 38 research projects in 11 universities to 64 faculties and 63 research fellows worth â‚¹7.5 crore, the results of which were published as 27 research papers and 42 conference presentations. Sharing his thoughts at a discussion on the topic, "Government Initiatives and Investors Perspective," Mr Saxena suggested the biotech companies of Gujarat to create a forum for interaction and advised them to take advantage of various schemes of the government of India and state government programs for skill development, entrepreneurship, and technology transfer. Earlier, Mr Ravi saxena, additional chief secretary, Department of Science and Technology, Government of Gujarat, stressed upon the need for strong participation of industries in holistic development of biotechnology. This was followed by distribution of investment intention certificates to those companies who have committed their investment in Gujarat during Vibrant Gujarat event 2013. Around 53 biotech companies have committed â‚¹1,800 crore for the next five years in Gujarat. Around 17 different companies, institutes, and organizations have also entered into strategic partnership with GSBTM, which include, National Innovation Council, Griffith university, Jawaharlal Nehru Tropical Genetic Research Institute and Birla Institute of Research. The event was attended by over 100 participants representing 45 biotechnology companies. These included Concord Biotech, Hester Bioscience, Human Biosciences, Anil BioPlus, Maps Enzymes, Axio Biosolutions, Aura Herbal, Alexandria, and Gujarat Eco Microbial Technologies. ]]> <![CDATA[Omron India launches blood glucose monitor]]> https://biospectrumindia.com/news/95/6109/omron-india-launches-blood-glucose-monitor.html https://biospectrumindia.com/news/95/6109/omron-india-launches-blood-glucose-monitor.html Thu, 17 Jan 2013 12:43:00 +0530 Omron Healthcare India, the leader in innovative medical technologies and products for monitoring and therapy has launched an easy-to-use, economical "Blood Glucose Monitor - HGM111" and ultra light weight "Blood Glucose Monitor - HGM112". Priced at â‚¹1,980, the Blood Glucose Monitor - HGM 111 comes with a large LCD screen and provides accurate measurements of glucose level within five seconds. The device stores up to 512 sets of measurement and can provide average data for 7, 14 and 30 days. It enables consumers to download their testing records on to the computer as well. With Ultra light weight, the Blood Glucose Monitor - HGM 112 weighs a miniscule 25.5 gms including battery. With fast testing time within five secs, this glucose monitor is priced at a nominal rate of â‚¹990. Speaking on the occasion, Mr Takuichi Shimizu, president, OMRON Management Centre of India said, "The recent rise of emerging markets in Asia and in the heavily populated countries such as China and India in particular, consumer markets are expanding rapidly. This in turn is generating massive demand for Omron's products and solutions." Adding further, Mr Shinya Tomoda, MD, OMRON Healthcare India said, "Indian medical devices and diagnostics market is estimated to reach Rs 275 billion and the country is fast emerging as the diagnostic capital of the world. We have 57 percent (Unit base) market share in the blood pressure monitor market in India. With the launch of our new range of Blood Glucose Monitor we look forward to continue being the market leader with similar impetus." Launching the product for Indian masses, Mr Farhan Akhtar, film director, producer, actor and also the brand ambassador for Omron Healthcare in India, said, "Keeping fit and staying healthy is essential for everyone in this fast-paced age. I am delighted to partner with Omron in its mission towards realization of a healthy life and prevention and treatment of lifestyle related diseases. Strict adherence to international quality and safety standards makes Omron the right choice for you and your loved ones". Omron Healthcare India first established its representative office in 1997 and got officially incorporated in 2010 with offices in major cities of India. The company expects to increase its sales to $43 million by end of FY 2015 from its current $14 million from its Indian operation. ]]> <![CDATA[Battle over GM moratorium continues]]> https://biospectrumindia.com/news/95/2959/battle-over-gm-moratorium-continues.html https://biospectrumindia.com/news/95/2959/battle-over-gm-moratorium-continues.html Thu, 17 Jan 2013 12:01:00 +0530 The entire operations of the regulatory agencies, the research activities on GM crops and in turn the need of the country to realize the potential benefit of modern biotechnology in terms of food security would come to a virtual halt, if field trails of GM crops are stopped in the country. This is what, according to sources, the union ministry of agriculture has mentioned in its action taken report, which was submitted to the panel in November 2012. Noting that the field trails are integral part of research and development, the ministry has mentioned in the report that the biosafety research cannot be conducted in glass house as safety efficacy and the performance of GM crops would vary depending upon host environment, host crop and inserted gene. In the backdrop of the report, the union minister for agriculture, Mr Sharad Pawar had recently mentioned to media that the research on GM crops and their field trials should continue in a country such as ours, which has huge population. He also however said that caution should be exercised while allowing GM crops for commercial cultivation. Earlier, the panel headed by the member of parilament, Mr Basudeb Acharya had recommended the government to stop all open-field trials of transgenic crops until it develops a better system of monitoring and oversight. Meanwhile, the Supreme Court too had earlier refused to halt the field trials of the GM crops recommended by the technical expert committee (TEC), seeking a 10-year moratorium on field trials on GM crops. Taking note of the objections against the report, a Bench of Justices Mr Swatanter Kumar and Mr SJ Mukhopadaya on November 9, 2012 had refused to stay the ban of field trials and directed that all the objections be placed before the TEC for fresh consideration and asked the committee to submit its report in six weeks. With all the stakeholders ready to battle it out in the court and the final report of TEC being awaited eagerly, all eyes are set on the highest judicial authority for the final decision on GM crops. ]]> <![CDATA[Launch the drug in six months or face the music, says CDSCO]]> https://biospectrumindia.com/news/95/5210/launch-the-drug-in-six-months-or-face-the-music-says-cdsco.html https://biospectrumindia.com/news/95/5210/launch-the-drug-in-six-months-or-face-the-music-says-cdsco.html Thu, 17 Jan 2013 11:01:00 +0530 The Central Drugs Standard Control Organization (CDSCO) will cancel the permissions and licences given to the drug manufacturers, who fail to launch the particular product for marketing in the country within a period of six months after obtaining the permission from the CDSCO. The drug controller general of India (DCGI), Dr GN Singh has sent a notice to all state licensing authorities to implement the order which puts a time limit for the manufacturers or applicants to launch their products after securing permission. "Under the Drugs and Cosmetics (D&C) Rule, 1945, permission to manufacture a new drug is granted by CDSCO. Based on the permission received from the CDSCO, manufacturer obtains manufacturing licence from the concerned state licensing authorities. As per Schedule Y, periodic safety update reports (PSURs) of new drugs are required to be submitted every six months for the first two years after approval of the drug is granted," said the notice dated January 11, 2013 by the DCGI. "For subsequent years, the PSURs need to be submitted annually. PSURs are important for assessing the safety and efficacy in post marketing scenario. However, it has been observed many times that the manufacturers do not launch the product even after years of getting approval from this office and the manufacturers do not submit the required PSUR, while the drug does not remain a new drug after a period of four years. Therefore, the assessment of safety and efficacy of such new drug in the post marketing scenario remains incomplete," he said. It has been therefore decided in public interest that, just in case an applicant fails to launch the product for marketing in the country within a period of six months from obtaining the permission, the licence will be treated as cancelled, directing the state authorities to take necessary steps in this regard. ]]> <![CDATA[AIIMS director: Think big to tap the potential of biotechnology]]> https://biospectrumindia.com/news/95/2960/aiims-director-think-big-to-tap-the-potential-of-biotechnology.html https://biospectrumindia.com/news/95/2960/aiims-director-think-big-to-tap-the-potential-of-biotechnology.html Wed, 16 Jan 2013 15:50:00 +0530 "This is the time to move forward towards the high-end devices. For that we have to realize the full potential of biotechnology not only for India but the global markets." This was stated by Dr Ramesh C Deka, director, All India Institute of Medical Sciences (AIIMS) while speaking at the 6th annual Meditech Summit 2012, held on December 21, 2012 and organized by the Standford India Biodesign at New Delhi. Dr Deka mentioned that there is availability of funds from various agencies but the utilization is not happening as per requirement. "We are buying very huge and expensive technology from abroad. There have to be efforts towards the development of miniature technological devices indigenously," added Dr Deka. AIIMS director further exhorted the young fellows who are part of the joint fellowship program to think big and be partners in the global change. "The initial focus on small scale medical devices is fine but why not explore the potential areas of vaccine and diagnostics for tackling the disease?" he asked. The summit was earlier inaugurated by the minister of state for human resources development, Mr Shashi Tharoor. In his address to the participants, he underlined the need to do innovative research to contain the mortality rate. The medical devices are used by only 20% of the Indian population, but I hope that the scenario will change given the positive results shown by the National Rural Health Mission (NRHM) and Rashtriya Swasthya Bima Yojna (RSBY). The IT-enabled technologies, smart cards are shifting the paradigm in the healthcare. The minister also revealed that HRD ministry is pushing for the opening of new 14 centres of excellences to incorporate innovative incubation. Healthcare has to given utmost priority. Health issues are pushing poverty beyond limits. The cutting-edge biotech research happening in India can resolve lot of problems in long run," he added optimistically. The event was attended by close to 200 delegates including various speakers from the government, industry and academia. The one-day summit saw the special lectures by eminent persons including Dr T Ramaswami, secretary, Department of Science and Technology, government of India; Dr Anurag Mittal, associate director, Stanford-India Biodesign and Prof. Balram Bhargava, executive director, Stanford-India Biodesign. There were also two guest lectures by Dr Shailendra Vyakarnam, director, Centre for Entrepreneurial Learning, Cambridge University, United Kingdom and Dr Saurab Srivastava, member, National innovation Council. ]]> <![CDATA[Daiichi Sankyo, Ranbaxy integrate business operations]]> https://biospectrumindia.com/news/95/3662/daiichi-sankyo-ranbaxy-integrate-business-operations.html https://biospectrumindia.com/news/95/3662/daiichi-sankyo-ranbaxy-integrate-business-operations.html Wed, 16 Jan 2013 14:14:00 +0530 Daiichi Sankyo Company and Ranbaxy Laboratories have announced their intention to integrate their business operations in Thailand, to leverage and maximize the synergies of a hybrid business model. Under this strategy, Daiichi Sankyo and Ranbaxy would integrate the management of Daiichi Sankyo's subsidiary in Thailand, Daiichi Sankyo Thailand (DSTH) and Ranbaxy's Thailand subsidiary, Ranbaxy Unichem (RUCL). The new representative of the proposed integrated entity will be Suthas Thongprasert, who presently heads DSTH. Business is set to commence on April 1, 2013. The pharmaceutical market in Thailand is the 2nd largest among ASEAN countries, and DSTH, has built its presence mainly by targeting healthcare facilities through innovative pharmaceuticals. The company was founded in 1994 and had sales of US $13 million (JPY 1.2 billion yen) in FY 2011. On the other hand, RUCL markets generic medicines focusing on primary healthcare and pharmacies. RUCL was established in 1983 and had sales of US $14 million in FY 2011. The planned integration of operations will provide a strong foundation for the future Daiichi Sankyo Group business expansion in Thailand. The development is set to be mutually beneficial to Ranbaxy and Daiichi Sankyo. It is expected to enhance their competitiveness while offering both innovative, affordable and high quality generic medicines to the people of Thailand as well as generate cost synergies for both companies. ]]> <![CDATA[Five-fold funding boost for ICMR in 12th Plan ]]> https://biospectrumindia.com/news/95/1269/five-fold-funding-boost-for-icmr-in-12th-plan-.html https://biospectrumindia.com/news/95/1269/five-fold-funding-boost-for-icmr-in-12th-plan-.html Wed, 16 Jan 2013 12:38:00 +0530 More than â‚¹10,000 crore are earmarked for the department of health research (DHR) and Indian council for medical research (ICMR) in the 12th Five Year Plan, which is almost five times more than the funds received in the 11th Plan. This was revealed by the union health minister, Mr Ghulam Nabi Azad recently at the inauguration of Asia's first biosafety level-IV laboratory at Pune. According to Mr Azad, "It is a matter of satisfaction that "Health" has been given a central position in the 12th Plan and the outlay for health, including health research, has gone up substantially." The major schemes to be rolled out in the area of health research during the 12th Plan period: â– Establishment of multidisciplinary research units in 150 government medical colleges â– Setting up of 50 rural health research units at block level â– Establishment of a network of 250 laboratories at regional, state and district level for managing epidemics â– Grant-in-aid to researchers on projects involving development of affordable technologies, reagents and methods for public use â– Strengthen the existing ICMR institutes and set-up new centres in deficit areas â– Suggest and regularly update standard treatment guidelines â– Bench mark and cccredit health research institutions â– Support human esource development for producing qualified researchers ]]> <![CDATA[HIV infections on decline in India, says health minister ]]> https://biospectrumindia.com/news/95/5748/hiv-infections-on-decline-in-india-says-health-minister-.html https://biospectrumindia.com/news/95/5748/hiv-infections-on-decline-in-india-says-health-minister-.html Wed, 16 Jan 2013 12:10:23 +0530 The union minister for health, Mr Ghulam Nabi Azad has said that the successful implementation of the human immunodeficiency virus/ acquired immune deficiency syndrome (HIV/AIDS) program by India has earned global appreciation. "The new evidence, from the latest round of HIV estimations, corroborates the fact that there is consistent decline in HIV prevalence, new infections as well as deaths due to AIDS-related causes in India. The reduction in annual new HIV infections by around 57% over the last decade signifies the progress towards halting and reversing the epidemic," explained the minister while speaking at the BRICS (Brazil, Russia, India, China, and South Africa) health ministers' meeting held at New Delhi on January 11, 2013. Keeping in view the rapidly increasing burden of non-communicable diseases (NCDs) across the globe, the health ministry has launched mass screening for early detection of NCDs like diabetes, hypertension and cancer. With a substantial increase in the budget outlay for health, the ministry proposes to take several new initiatives to consolidate the gains and to fill up the gaps in critical areas of healthcare, research, human resources and infrastructure, over the next five years. Speaking further on the issue, Mr Azad stated, "The special session of the UN General Assembly, held on September 2011, recognized the escalating threat posed by NCDs to the continued economic development of low and middle income countries and also their being a major barrier to the achievement of millennium development goals relating to poverty reduction, maternal and child health, control of AIDS, tuberculosis and malaria. We must, therefore, learn from each other and commit to fight NCDs together on the BRICS platform, through innovative strategies." The meeting was also addressed by Mr Chen Zhu, minister of health, people's republic of China; Dr Pakishe Aaron Motsoaledi, minister of health, South Africa; Mr Sergey Velmyaykin, deputy minister of health, Russia; Mr RS Padilha, minister of health, Brazil; Mr Michael Sidibe, executive director, UNAIDS; and Dr S Plianbangchang, regional director, WHO, South-East Asia Regional Office (SEARO). ]]> <![CDATA[Goose launches barcode solutions for drug industry ]]> https://biospectrumindia.com/news/95/1302/goose-launches-barcode-solutions-for-drug-industry-.html https://biospectrumindia.com/news/95/1302/goose-launches-barcode-solutions-for-drug-industry-.html Wed, 16 Jan 2013 11:00:00 +0530 Pharmaceutical business re-engineering solutions specialist, Goose recently launched "Goose Tracker", a cost-effective new generation 2D serialization barcode for the pharma industry with a choice to choose online or offline solution to secure and protect both consumers and the pharmaceutical companies. Its multi-level authentication features allow tracking of product throughout the distribution channel including warehouse to customer retail chain. Leading pharma companies like Strides Arcolab, Indoco Remedies and Macleods Pharmaceuticals have already implemented and adopted Goose Tracker for track and trace solution. The company expects a rise in demand and surge in Goose Tracker customer portfolio as pharmaceutical companies get set to implement secondary bar coding which is now compulsory for pharmaceutical exports from January 1, 2013. Goose Tracker incorporates several new changes to suit GS1 global traceability guidelines. It's serialization algorithm generates billions of unique numbers. It does not store serial numbers in the database for enhanced security and includes a dynamic engine to interact with ERP systems for data retrieval. This solution provides offline application for entities in the supply chain that do not have access to the main database. Goose founder and CEO, Mr Deb Pattnaik says,"Goose Tracker integrates with existing applications to securely meet data management and printing needs for packaging and shipping labels. We are working with several government and non-government entities to include changes as and when they are announced." The World Health Organization (WHO) estimates that counterfeit drug prevalence rates fall between 10 percent and 30 percent in the developing world, compared to 1 percent or less in industrialized nations. India exports over $12 billion of its generic drug annually to more than 180 countries. Goose Tracker is designed to enable Pharma exporters complement their bar coding initiative to become reliable exporter of quality pharmaceutical products in the international market and strengthen their fight against counterfeiting.Users can also validate the authenticity of the product by using SMS, IVR or website. ]]> <![CDATA[India gets WHO approval for vaccine exports]]> https://biospectrumindia.com/features/95/6242/india-gets-who-approval-for-vaccine-exports.html https://biospectrumindia.com/features/95/6242/india-gets-who-approval-for-vaccine-exports.html Tue, 15 Jan 2013 12:52:00 +0530 A World Health Organization (WHO) team consisting of 16 experts from different nationalities have assessed the vaccine clearance procedures of the Indian Central Drugs Standard Control Organization (CDSCO) and NRA (National Regulatory Authority (NRA) and found them to be "stringent enough and (that) the international community can be assured that vaccines produced by Indian companies are of high quality, safe and efficacious." The NRA adhered to the six critical control functions laid out by WHO, thus receiving the official accreditation from the public health agency. The stamp of approval from the WHO for the country's regulatory body comes as a welcome move, not just because it helps open up doors to Rest Of the World (ROW) markets and international aid agencies for Indian manufacturers, but also because it helps clear India's image in terms of quality of vaccines that had taken a beating in recent times. The WHO approval also holds special meaning, since India has failed the same audit which was previously carried out in 2009, not once but on three separate occasions in the past. It would also make India the first country to pass the current required norms. The Drug Controller General of India (DCGI) explicitly stated that, had Indian failed to meet the necessary criteria, it would have had to stop the export of its vaccines to over 159 countries. The audit team however concluded that more could be done in the areas of pharmacovigilance and reporting of adverse events following vaccination. Currently, India's vaccine exports include primary ones such as those for diphtheria, pertussis and tetanus, of which India caters to 80 percent of the world's supply as well as other comparatively advanced ones such as those for hepatitis, meningitis and the pentavalent vaccines. Companies manufacture 30 different types of vaccines for domestic as well as the international use. On receiving the approval, the Drug Controller General of India, Dr GN Singh said, "We have passed with flying colors. India has become the first country to pass the stringent indicators put in place by the WHO, in one shot. WHO has also assured us of their help in capacity building on drug regulation in India. The team has expressed total confidence in the quality of Indian vaccines being exported to all corners of the world." A WHO endorsement remains crucial since international aid agencies such as GAVI (Global Alliance for Vaccines and Immunization), WHO and UN (United Nations) aid agencies all source their vaccine subjects to a WHO prequalification approval. Experts also hope that a WHO approval for the country's regulatory body can have far reaching implications, that might result in domestic manufacturers also adhering to the highest standards in quality. Dr Harish Iyer, CEO, Shantha Biotechnics says, "This move is very positive as it confirms that Indian vaccine manufacturers will continue to play a major role in the procurement of United Nations Agencies and emerging countries in general." WHO approvals and those of the national agencies such as NRA hold special significance. Dr Satish D Ravetkar, executive director, Serum Institute of India, said, "WHO audits are an ongoing exercise at Serum Institute, specific to each vaccine that we manufacture. Due to our robust quality systems that are ingrained in the DNA of the company, we do not face any problems." Serum Institute of India is the largest vaccine company in India, and over 80 percent of the global vaccines requirement are catered by it. Dr Harish Iyer, echoes the importance of exports by saying, "Exports featured highly in Shantha's case, with more than three quarters of our revenues in 2012 coming from exports. We have conducted a quality, safety and immunogenicity development plan, including manufacturing, regulatory and clinical aspects, designed to strongly improve the robustness of the processes used by Shantha in the past few years as well." "In the last four years, the government has been under pressure after WHO cracked down on the government and some of the private units for lack of quality, safety and efficacious issues. The steps taken by the government during this period like capacity building, strengthening of manpower (regulators), e-governance system to increase transparency and credibility, stringent monitoring system, consumer awareness programs, up gradation of existing central drugs laboratories and conduct regular overseas inspections to verify GMP compliance and other statutory requirements and many other initiatives helped the WHO team to give green signal for the export of Indian vaccines. Now it is time for the Indian vaccine industry to maintain the status without compromising on quality, safety and efficacy of life saving vaccines by following transparency and ethical practices," opined Mr KV Balasubramaniam, managing director, Indian Immunologicals. Exports set; What about India? According to a recently released report by McKinsey - Organization of Pharmaceutical Producers of India (OPPI), in 2012, close to 2 million Indians, mainly children, died from diseases that could have been prevented by vaccines. Also alarming is the fact that according to data from the Ministry of Health and Family Welfare, the immunization budget for routine immunization as well as the pulse polio program has in fact reduced from 5.5 percent of the healthcare budget in 2010-11 to 4.7 percent in 2011-12. The report also mentioned that the Indian vaccines market remains under-penetrated for several reasons such as lack of awareness or ability to purchase the vaccine. But this scenario could change. Over the next decade, the Indian vaccines market has the potential to substantially increase the number of lives saved by improving access to different types of vaccines available and the depth of coverage of those vaccines across the country. The report also suggested that government and pharmaceutical companies can stimulate the expansion of vaccines in India through a number of actions, notably reducing complexity in the Universal Immunization Program (UIP) process, increasing the prescriber base, improving sales and marketing and investing in delivery and supply. The stakeholders such as government and industry need to play a crucial role in realizing this transformation to counter the significant mortality crisis associated with a small and under-penetrated vaccines market. Sustained, progressive and collaborative efforts by the industry and policy makers can make this potential a reality. As Indian units gear up to supply life saving vaccines to the rest of the world, a thought to ponder is, how long will it be before the Indian population can reap the benefits of its scientific and technological prowess. ]]> <![CDATA[Compulsory licenses to hit Indian pharma market]]> https://biospectrumindia.com/news/95/4180/compulsory-licenses-to-hit-indian-pharma-market.html https://biospectrumindia.com/news/95/4180/compulsory-licenses-to-hit-indian-pharma-market.html Mon, 14 Jan 2013 18:54:00 +0530 According to a recent report in the Indian Express, the Department of Pharmaceuticals has initiated the proceedings to grant compulsory licenses for three anti- cancer drugs namely, Trastuzumab , Ixabepilone and Dasatinib. Trastuzumab, an innovator biologic is marketed as Herceptin by Roche for HER2+ breast cancer patients. The drug, a monoclonal antibody, has been hailed as revolutionary, for providing a subsect of people affected breast cancer a chance to fight the disease. Ixabepilone is used for and has been developed by Bristol-Myers Squibb for the treatment of breast cancer in combination with another drug, after the failure of other drugs. Dasatinib is also a BMS drug marketed as Sprycel for the treatment of Chronic Myelogenous Leukemia (CML). It will be interesting to note, which Indian biotech company will be granted the compulsory license to produce the blockbuster biologic, Herceptin. BioSpectrum had earlier looked at both the sides of the Compulsory Licensing story here. While its keenest advocates have welcomed the governments' proactive stance for affordable healthcare, prominent members of the MNC pharma lobby have called it a measure to stifle innovation which does not expand access to drugs. Up until now, a compulsory license has been granted only to Natco Pharma for the anti cancer drug Nexavar, originally marketed by Bayer, in August last year. The license created a storm in the Indian pharma industry with activist groups applauding the decision as it would pave way for similar action with other expensive drugs. ]]> <![CDATA[India celebrates 2 years without polio]]> https://biospectrumindia.com/news/95/3190/india-celebrates-2-years-without-polio.html https://biospectrumindia.com/news/95/3190/india-celebrates-2-years-without-polio.html Mon, 14 Jan 2013 16:17:00 +0530 The National Immunization Day, 2013 was celebrated with aplomb on January 13th, as it coincinded with India being polio free for two whole years. s Aa part of the commemoration of this important milestone, the president of India, Mr Pranab Mukherjee administered polio drops to children at Rashtrapati Bhavan. Mr Ghulam Nabi Azad, union minister of health and family welfare, Mr S Gandhi Selvan, minister of state for health and family welfare, Dr AK Walia, health minister, government of NCT of Delhi, representatives from WHO, UNICEF, USAIDS and Rotary India and other partners were present on the occasion. Speaking on the historic occasion, Mr Ghulam Nabi Azad said, "I am extremely happy to inform this august gathering that today is a momentous day for the whole country, as India has completed two years without any case of wild polio virus." On 25th February 2012, the World Health Organization had removed India from the list of polio endemic countries, which was a historical achievement since there was a perception among many experts that India would be the last country to eradicate polio. Until 2009, India accounted for half of the total polio cases in the world. Mr Seth Berkeley, CEO, GAVI Alliance, one of the leading non profit agencies working in the area of vaccines tweeted that, "India's second polio-free anniversary is a huge achievement. Vaccination and surveillance must continue to end polio. (Now) the stakes are higher than ever to sustain progress and end polio globally." Mr Azad pointed out that the polio eradication effort will continue to be one of the thrust areas of the Government. Pakistan, Afghanistan and Nigeria still continue to be polio endemic countries in the world. Mr. Azad also added, "I am happy to inform you that the nation-wide immunization campaign for polio eradication will start on 20 January, 2013, in which more than 170 million children of less than five years of age will be given polio drops. More than 23 lakh volunteers will participate in this massive national effort, with more than 1.5 lakh supervisors monitoring the quality and coverage of the Immunization activity." ]]> <![CDATA[Sanofi to acquire Dosch's veterinary health unit]]> https://biospectrumindia.com/news/95/2031/sanofi-to-acquire-doschs-veterinary-health-unit.html https://biospectrumindia.com/news/95/2031/sanofi-to-acquire-doschs-veterinary-health-unit.html Fri, 11 Jan 2013 12:17:00 +0530 The French drug company Sanofi recently announced its decision to enter into a binding agreement to acquire the animal health division of Dosch Pharmaceuticals, creating a market entry for its animal health division, Merial, in the strategically important and growing animal health sector. The agreement is subjected to regulatory approval and is expected to be finalized in the first half of 2013. Dosch Pharmaceuticals, headquartered in Mumbai was incorporated in 1992 and is a diversified pharmaceutical company, primarily operating through two divisions, animal health and exports. The animal health division being acquired by Merial has more than 86 products under 50 brands for ruminants, poultry and companion animals. Products include an extensive range of animal health therapeutics and nutritional feed supplements. Within the animal health division, Dosch has a 279 member sales force, covering 18 Indian states. Merial employs approximately 5,600 people and operates in more than 150 countries worldwide. "The acquisition of Dosch's Animal Health Division will be a significant milestone for Merial and give us a strategic platform for our development in the Indian market," said Mr Jose Barella, chief executive officer, Merial. "We are convinced that the combination of Dosch's animal health brands and distribution strength, along with the robust new product pipelines from both Merial and Dosch, will strongly position Merial to become rapidly a major animal health player in India," Mr Barella added. "The strong nationwide sales, marketing and distribution network of Dosch, along with established products and people will be an ideal platform for Merial to enter the fast developing animal health market of India. Merial's entry will further strengthen the existing offering of Dosch's animal health business and provide a larger canvas for the market and the Dosch team," said Mr Sanjay Doshi, chairman and managing director, Dosch Pharmaceuticals. Dr Sharat Tugnait, CEO, Dosch Pharma and his management team will manage the future combined operations of Dosch and Merial in India under the supervision of Mr Mayank Parekh, Merial country manager for India. According to Merial, the animal health market in India is estimated to be more than â‚¬350 million in 2012, and is experiencing annual double-digit growth. India is home to the world's largest herd of cattle and buffalo, has the second largest herd of sheep and goats, and world's fifth largest population of poultry. India is also the world's largest milk producer. ]]> <![CDATA[Saina Nehwal lauds ICRISAT's efforts]]> https://biospectrumindia.com/news/95/1825/saina-nehwal-lauds-icrisats-efforts.html https://biospectrumindia.com/news/95/1825/saina-nehwal-lauds-icrisats-efforts.html Thu, 10 Jan 2013 10:30:00 +0530 India's ace badminton player and Olympic bronze medalist Ms Saina Nehwal recently visited the Hyderabad-based International Crops Research Institute for the Semi-Arid Tropics (ICRISAT). Ms Nehwal was there on the institute's invitation to help spread the importance of the genetic conservation in the global fight against hunger and poverty. Ms Nehwal described her experience after touring the institute's facilities, particularly its RS Paroda Genebank, as delightful and an eye-opener. She said, "ICRISAT's plant genetic conservation initiatives illustrate the value and use of biodiversity in the fight against hunger and poverty, and its impact on the livelihoods of millions of smallholder farmers in the dryland tropics." ICRISAT has been conducting research-for-development initiatives with global partners for the past 40 years to increase agricultural production in the semi-arid regions of Asia and sub-Saharan Africa. ICRISAT's genebank, one of the world's largest public-funded genebanks, preserves seeds of more than 120,000 accessions of pearl millet, sorghum, chickpea, pigeon pea, groundnut and small millets (finger millet, foxtail millet, barnyard millet, kodo millet, and little millet), that are kept as in-trust collections on behalf of the Food and Agriculture Organization (FAO) of the United Nations (UN), for the benefit of the present and future generations. It has also distributed more than 1.4 million seed samples to 146 countries, restored about 55,000 germplasm lines to 9 countries, and released over 830 cultivars in 79 countries from its germplasm and breeding materials. Ms Newhal added that, "Nature has truly blessed us with a rich genetic diversity, which is unique and important in sustaining life in this planet. This visit gave me a better understanding of the importance of plant genetic conservation in sustaining and using genetic diversity for global food security." About the Genebank, Dr William D Dar, director general, ICRISAT, said, "ICRISAT's RS Paroda Genebank is a treasure trove of genes which are useful for crop improvement for sustainable food production and improved livelihoods, particularly in marginal environments, and the genes that can provide climate resilience to future crop varieties through increased drought, heat and salinity tolerance, and pest and disease resistance." Ms Nehwal was recently honoured with a doctorate degree by Mangalayatan University, Uttar Pradesh to commemorate her achievement in the world of sports. ]]> <![CDATA[Enzyme business all set for quantum leap]]> https://biospectrumindia.com/views/95/1129/enzyme-business-all-set-for-quantum-leap.html https://biospectrumindia.com/views/95/1129/enzyme-business-all-set-for-quantum-leap.html Wed, 19 Dec 2012 10:46:00 +0530 In the global business warfare, every country has created its own niche. While China is known for its manufacturing competency, the US for its technological leadership, India in the last two decades has been able to make its mark on the global map through its IT services revolution. Going forward, India is advantageously positioned in the biotech sector and has immense potential to become the new global leader in the next decade, if it takes the right steps. India is already ranked among the top 12 biotech destinations worldwide and third largest in the Asia-Pacific region. The industrial biotechnology market accounts for approximately four percent of the biotech industry, mainly comprising of industrial enzymes that clocked Rs625.94 crore in 2010-11, growing at a rate of 10.98 percent for 2010-11, as against Rs564 crore in 2009-10. Although, enzymes have been used for more than 50 years in the detergent, textile, food and feed industries, Indian industrial enzyme market is at nascent stage with a marginal share in the global market. However, it is ready for the next leap as it is forecasted to grow at a CAGR of 15 percent till 2015. Increasing environmental concerns, climate-change issues, stricter industry regulations, and recognition of the need for more sustainable products are the factors driving the growth of the industrial biotech segment especially, food and beverage, detergents, textiles, and fuel ethanol. While the majority of the companies in India have started to acknowledge the benefits of the biotech solutions, most of them are still reluctant to change from the traditional practices. Cost has been seen as a major barrier in the adoption of new technologies, which is not always the case, especially in the long run. The other bottlenecks are regulatory approvals. While there is a big effort from the regulatory authorities to make the regulatory frame work in line with international best practices, the approval process still remains cumbersome. This makes it difficult to implement innovations and commercially launch new products for the benefit of the industry. However, this perception seems to change to positive momentum for the segment as the industry realizes the effectiveness of the solutions in their businesses. With the environment issue gaining importance globally, sustainability will be the game changing proposition. In a marketplace where the consumers are increasingly becoming environment conscious, slowly but steadily, like in other developed markets, sustainability will increasingly become a business driver for most of the companies in India also. The adoption of sustainable technology is still low in India as compared to some other developed countries. Unlike Europe, where voluntary codes are self-adopted by the industry, it takes longer in India to make companies realize the long-term benefits of the technology. However, the government is taking positive steps to facilitate the adoption of the technology, keeping in mind the impending resource crunch that can hamper growth. The government has provided a major thrust to this sector and has come up with progressive regulations and policies to further enhance its impact. Going further, the biotech industry in India will be faced with complex regulatory challenges and decisions as the market further matures. Therefore, in order to enable a quantum leap for the industrial biotech industry, it is crucial that the government not only comes out with new regulation in line with the international standards but also makes the approval process faster and simpler. Some of the biotech solutions, such as 2G Ethanol, that will help reduce our dependency on fossil fuels, creates job opportunities and ensure inclusive growth, need proactive financial support and involvement from the government. The Indian industrial biotech industry has laid a good foundation and is on its way to become a global player. No doubt there are always challenges for persistent success in a developing country, however, we can reap the benefits of this opportunity, only through firm strategies, active industry-academia participation, and most importantly proactive policies of the government. ]]> <![CDATA[National Biodesign Alliance established in India]]> https://biospectrumindia.com/news/95/2977/national-biodesign-alliance-established-in-india.html https://biospectrumindia.com/news/95/2977/national-biodesign-alliance-established-in-india.html Tue, 18 Dec 2012 14:50:02 +0530 A National Biodesign Alliance has been established by the Department of Biotechnology in association with various partners such as the Indian Institute of Technology (IIT), New Delhi, IIT-Madras, All India Institute of Medical Sciences (AIIMS), New Delhi, Regional Centre for Bio-Technology (RCB), Faridabad, Translational Health Science and Technology Institute (THSTI), Faridabad, International Centre for Genetic Engineering and Biotechnology (ICGEB), Delhi, Indian Institute of Science (IISc), Bangalore and Christian Medical College (CMC), Vellore. This alliance aims to help the institutes to coordinate with each other on the Biodesign programs in the country. A memorandum of association has been signed amongst the partners for twinning engineering and medical schools to promote innovation through a multi-disciplinary approach. The partner institutions are sharing ideas, facilities and resources and contributing to the training programs for research fellows, interns and young innovators. Currently, various research programs with focus on the development of affordable technologies in the areas of implants, devices, and in-vitro diagnostics have been undertaken. ]]> <![CDATA[Abraxane gets FDA nod for lung cancer treatment]]> https://biospectrumindia.com/news/95/4193/abraxane-gets-fda-nod-for-lung-cancer-treatment.html https://biospectrumindia.com/news/95/4193/abraxane-gets-fda-nod-for-lung-cancer-treatment.html Fri, 14 Dec 2012 15:45:00 +0530 The USFDA has approved Abraxane for the first-line treatment of locally advanced or metastatic non-small cell lung cancer in combination with carboplatin. Abraxane is an albumin-bound form of paclitaxel that is manufactured using patented nab technology. It is formulated with albumin, a human protein, and is free of solvents. The Abraxane sNDA approval is based upon the results of CA-031, a phase III, multi-center, randomized open-label study. This approval marks the second indication for Abraxane in the United States. It was first approved in 2005 for the treatment of metastatic breast cancer after failure of combination chemotherapy. Apart from the US, Abraxane is also available in Europe, Canada, Russia, Australia, New Zealand, India, South Korea, Bhutan, Nepal, United Arab Emirates and China for the treatment of metastatic breast cancer. "Non-small cell is the most common type of lung cancer, the leading cause of cancer death in the United States," said Dr Mark A Socinski, director, Lung Cancer Section, Division of Hematology/Oncology, University of Pittsburgh, and lead investigator of Abraxane phase II and phase III lung cancer trials. "The FDA approval of Abraxane is exciting for healthcare professionals because it offers an important new treatment option for all types of non-small cell lung cancer patients, in an area that has seen few treatment advancements in recent years." Abraxane is currently in various stages of investigation for the treatment of cancers such as pancreatic, metastatic melanoma, bladder, ovarian, and expanded applications for breast cancer. In India, Panacea Biotec had launched PacliALL, an indigenously developed formulation of the Paclitaxel, the active ingredient of Abraxane in February 2011. ]]> <![CDATA[LifeCell plans to launch dendritic cell cancer vaccine ]]> https://biospectrumindia.com/news/95/5557/lifecell-plans-to-launch-dendritic-cell-cancer-vaccine-.html https://biospectrumindia.com/news/95/5557/lifecell-plans-to-launch-dendritic-cell-cancer-vaccine-.html Thu, 13 Dec 2012 15:35:39 +0530 LifeCell, one of India's largest stem cell banking companies recently revealed that, in addition to facilitating the collection and storage of umbilical cord stem cells, it is also spending part of its efforts into researching the use of stem cells for therapies. One of the technologies that LifeCell hopes to introduce to the Indian population in the next few years is that of the dendritic cell cancer vaccine, with the help of the US-based Dendreon. Mr Mayur Abhaya, president and executive director, LifeCell International said that the vaccine could be useful for conditions such as brain tumours or glioblastomas. "The laboratory work regarding the dendritic cell cancer vaccine is ongoing. We hope to bring this technology to India. Even though it might take some time for the translation of these studies, I hope that the Indian population can benefit from our attempts to leverage what is currently happening worldwide in stem cell research." A dendritic cell is an immune cell that recognizes, and presents foreign antigens to the T-cells which mount an immune response. Dendritic cell therapy thus involves the harvesting of blood cells from a patient and processing them in the laboratory to produce dendritic cells that are then given back to a patient in order to allow massive dendritic cell participation in optimally activating the immune system.The study of immune responses by dendritic cells, which forms the basis of this vaccine, won Dr Ralph Steinman, the Nobel Prize for Medicine and Physiology in 2011. Other projects include evaluating mesenchymal stem cells for the treatment of critical limb ischaemia, for which the phase III clinical trials have been completed and the results are being evaluated. LifeCell also distributes a USFDA approved point of care device that extracts a patient's stem cells from the bone marrow within 15 minutes. The company had recently launched the Babyshield service for newborn screening of genetic diseases, which can dentify over 118 health conditions at birth, making it the most advanced newborn screening service in the world. Importantly, this test is done entirely in a non-invasive manner. LifeCell has a marketing force of 500 with over 1,500 collections done nationwide every month. The distribution of these services is however skewed with over 50 percent of the business being concentrated in the Top six metros of the country, owing to the higher percentage of educated professionals. ]]> <![CDATA[Mr Pranab Mukherjee: PPPs will steer us to second green revolution]]> https://biospectrumindia.com/reports-white-papers/95/3033/mr-pranab-mukherjee-ppps-will-steer-us-to-second-green-revolution.html https://biospectrumindia.com/reports-white-papers/95/3033/mr-pranab-mukherjee-ppps-will-steer-us-to-second-green-revolution.html Thu, 13 Dec 2012 14:12:00 +0530 "Given the critical linkage between agriculture and poverty alleviation, a faster agricultural growth to deliver inclusive development led by the second green revolution is urgently needed." These remarks were made by the president of India, Mr Pranab Mukherjee, while addressing the "National Conference on Ushering Second Green Revolution in Indian Agriculture through Public-Private Partnership", organized by the Confederation of Indian Industry (CII) with support from Ministry of agriculture on December 11, 2012 at New Delhi. Highlighting the challenges faced by the agricultural sector, Mr Mukherjee emphasized on the need to improve the seed replacement rate, promote adoption of hybrid seeds, incentivize balanced use of fertilizers and ensure efficient water management. He pointed out the need to render the second green revolution more holistic and widespread in developing the agricultural sector compared to the first green revolution and public private partnerships will play a key role. Complementing CII, Mr Mukherjee remarked that this is the right time for organizing such conference as agriculture is undergoing transformational growth and the policy environment is also conducive for initiating and scaling public private partnerships. On the very occasion, Mr Mukherjee launched the CII - Jubilant Bhartia Food and Agriculture Centre of Excellence (FACE). The conference was attended by key government officials, think tanks, industry stalwarts from agri input, irrigation, farm mechanization, food processing, and retail as well as farmer groups. More than 1000 participants attended the conference as well as the CII - ICAR technology exhibition. Few insights during the event Speaking at the conference, Mr Tariq Anwar, minister of state, Agriculture and Food Processing, government of India highlighted the achievements of the agricultural sector in achieving record in production of grains and horticulture produce. He remarked that the key challenges that continue to threaten sustainable growth can be adequately addressed through effective public private partnerships. Mr Bhupinder Singh Hooda, chief minister of Haryana, stated that PPP in second green revolution will play an important role in translating the policies and programs into action on the ground. Mr Hooda also highlighted the four PPP initiatives of government of Haryana under Haryana State Agriculture Marketing Board (HSAMB) in agriculture.Mr Adi B Godrej, president, CII, in his special address stressed on an immediate need for chalking out a plan that enables multi stakeholder partnerships to improve storage, market linkages, procurement practices, technology, research and extension. He further stated that a coherent policy framework and well-targeted public investments are essential for mobilizing private participation in agriculture. Introducing FACE, Mr Ajay Shriram, vice president, CII, and chairman and senior managing director, DCM Shriram Consolidated mentioned that, "FACE is charged with the mission of improving competitiveness of Indian agriculture sector by catalyzing innovation, building capacity and enhancing productivity across the agriculture and food value chain. With this objective, FACE aims at working closely with industry, farmers, developmental institutions and the government to build capacity while leveraging technology and innovation to improve productivity and the environmental footprint of agriculture." Mr Hari S Bhartia, former president, CII and co-chairman and managing director Jubilant Bhartia Group said, "FACE with its broad objectives is completely in sync with the national agenda of agriculture development and inclusive growth. FACE has already launched a series of initiatives on value chain assessments, supply chain management, and public private alliances with focus on improving market access and providing innovative business models that are scalable and replicable across geographies." Mr Rakesh Bharti Mittal, chairman, CII, National Council on Agriculture and vice chairman and managing director, Bharti Enterprises highlighted some of the successful interventions by the agribusiness companies and stressed the need for scaling these partnerships across the value chain.Mr S Gopalakrishnan, president designate, CII and executive co-chairman, Infosys remarked that PPP is vital for delivering inclusive and sustainable growth, but it needs to adhere to some key principles, such as focusing on local food markets, working with producer organisations and respecting the rights of small-scale producers, workers and communities. ]]> <![CDATA[Drought-tolerant rice genotypes]]> https://biospectrumindia.com/features/95/5645/drought-tolerant-rice-genotypes.html https://biospectrumindia.com/features/95/5645/drought-tolerant-rice-genotypes.html Tue, 11 Dec 2012 11:30:00 +0530 Despite being an agrarian economy, India continues to remain largely dependent on the unpredictable monsoons. Every year, due to adverse climate phenomena, farmers face huge crop loss owing to lack of adequate irrigation. With such a scenario, Bioseed Research India (BRI), a Hyderabad-based company and International Centre for Genetic Engineering and Biotechnology (ICGEB) joined hands to find a possible solution. Dr Paresh Verma, research director, Bioseed Reseach India, said that the work on developing drought tolerant genotypes was undertaken keeping in mind the Indian requirements. He added, "The frequency and intensity of drought is increasing by the day. Water resources are getting exhausted and even those areas which have access to water, lack power supply to irrigate their fields. In such a scenario, research on drought tolerant varieties of essential crops like rice can be very critical." In 2007, Bioseed Research India applied for and was successfully awarded a Small Business Innovation Research Initiative (SBIRI) grant amounting to Rs5.35 lakh, more than two-thrids of which was in the form of grant and soft loans to the two research organizations for developing drought-tolerant varieties of rice in association with ICGEB. Scientists at the Plant Molecular Biology Laboratory in ICGEB, through painstaking research, isolated several genes that were thought to provide tolerance to crops in drought conditions. A team of researchers at BRI then transferred these genes to the relevant plant species using genetic techniques. Proof-of-concept studies carried out in controlled conditions helped them narrow down to three genes that were showing measurable activity in the plants. Since drought tolerance is a complex trait, no single gene is said to confer tolerance in a plant. Hence these isolated genes are assumed to play a complementary role in conferring tolerance. The ambitious project was completed in 2011 and as a testimony to its success and innovative nature, ICGEB and BRI were awarded the 'Best Innovation in Agriculture Sector' award at the Innovator 2012 Awards organized by BIRAC. Way forward The work on this project, however is far from complete. BRI has now embarked on taking it further by accomplishing several tasks with DBT's support. Firstly, in collaboration with ICGEB, the three genes that were selected will now be stacked, allowing easy transfer into the plant species. Secondly, researchers have initiated the development of transgenic marker- free plants, that will possess the drought tolerance genes, but not any marker genes used for selection, antibiotic or otherwise. The first field trials for this variety are expected to be carried out in the coming year. Following other studies and approvals, it would take another 4-5 years for the seeds to reach the market. Separately, BRI has also started developing drought-tolerant hybrids using traditional techniques. About public private partnerships, Dr Verma said that, the complementary nature of both the participating entities' strengths has helped them achieve their goals. "Public institutions, though very proficient in basic research lack the resources and capability to move into product development. The private partner, however has a connect with the end user, the farmer. In our case, we had a strong breeding program and good bank of germplasms, which helped us take the initial research forward." ]]> <![CDATA[The beacon of innovation]]> https://biospectrumindia.com/news/95/2294/the-beacon-of-innovation.html https://biospectrumindia.com/news/95/2294/the-beacon-of-innovation.html Mon, 10 Dec 2012 13:25:00 +0530 Dr Renu Swarup adviser, Department of Biotechnology and managing director, Biotechnology Industry Research Assistance Council (BIRAC) Coming from the defence lineage, this disciplined and strong willed lady, who holds an overseas postdoctoral degree, is driving innovations in the biotech industry through the funding schemes thereby providing support for this niche and upcoming sector A passion for taking up challenging assignments in new fields motivated Dr Renu Swarup, a young lady with doctorate degree in genetics and plant breeding and post-doctoral research at The John Innes Centre, Norwich UK, to join a small team of over 20 people at the Department of Biotechnology (DBT), which was a spinoff from Department of Science and Technology and was just three years old then in 1989. From then on, there is no looking back for the lady who has spearheaded many initiatives, projects and programs on different topics at the DBT. During her career span of 23 years she has initiated many â€œfirstsâ€? at the department such as - the first centre for plant biotechnology at National Chemical Laboratory (NCL) at Pune. She was the part of the team that brought out 60 forestry regulation protocols for 10 million plants. Her role in the establishment of Lucknow Biotech Park, also has been exemplary, for which the then Prime Minister, Mr Atal Bihari Vajpayee, who incidentally represents Lucknow constituency in Parliament laid the foundation in 2003. Besides being a senior advisor to DBT, currently Dr Renu Swarup has been heading a new initiative of the department - Biotechnology Industry Research Assistance Council (BIRAC), a not-for-profit section 25 company of Government of India, set up with the idea to serve as a single window for emerging biotech industry as its first managing director. Dr Swarup played a key role in getting the new organization created and making it operational. The company successfully runs a large number of funding schemes for industry innovation, ranging from the ignition grant to proof of concept funding, validation and product development. The main focus of the organization is on enabling and supporting the biotech innovation ecosystem. The company is mandated to take discovery forward and encourage the product development by indigenous biotechnological companies. Dr Swarup considers herself fortunate enough to have worked on the programs such as Small Business Innovation Research Initiative (SBIRI) and Biotechnology Industry Partnership Program (BIPP). These programs were established to support innovation at the level of discovery upto the clinical stage. â€œWhen we started these programs long back, our vision was to have a futuristic programs for creating better options to meet the societal needs in the long run. I am proud to say that out of hundreds of projects supported by us so far, about 10 to 11 innovations have qualified for further development.â€?  Promoter of new initiatives  With promoting new ideas high on her agenda, Dr Renu Swarup has played a key role in new initiatives such as Biotechnology Industry Research Assistant Program (BIRAP) and Biotechnology Industry Partnership Program (BIPP), Energy Bioscience, Bioresource and Bioprospecting, Biotech Park Lucknow, and Epromis Application at DBT. She has also been closely involved in programs and activities related to women and science. She was responsible for implementation of DBT Scheme on Biotechnology Career Advancement for Women Scientists - BioCARe. She also promoted National Certification System for Tissue Culture Raised Plants (NCS-TCP) under Indo-Australia Biotechnology Program. DBT-TWAS Biotechnology Fellowship Scheme, BIOCARE Research Competitive Grant Fellowship and Career Research fellowship Donning the director's hat Recalling the initial discussions on creation of a program aimed at fostering innovation in the country in 2005, Dr Swarup, who was a part of the discussions held between the various stakeholders including industry experts, financial, legal and venture specialists, said, â€œWe came up with an announcement of strategy consultation amidst many ministries involved in the exercise. It was really a challenge for us to create a unique philosophy for a new organization and also ensure that it is not a copy of DBT and just complements the work of the former. That's when we authorized the Indian Institute of Management, Ahmedabad to prepare a report to find out what would be best for an organization that nurtures innovation. That resulted in the creation of Biotechnology Industry Research Assistance Program (BIRAP), a program to nurture innovation. Finally, in April 2012, it was incorporated as a section 25 public sector company known as BIRAC by the government of India to nurture and promote innovation research in the biotech enterprise with special focus on start-ups and SMEs.â€? 'We are here to instill confidence in entrepreneurs' Q What is stopping scientists to turn entrepreneurs in the biotech space? We definitely need to instill confidence in the new comers in the industry. We need to find out the reason why more scientists are not willing to turn into entrepreneurs and what is the actual barrier stopping them. We know that something is restricting them and the financial conditions might be one of the reasons along with the level of education and awareness. The lack of enough mentors and role models for the biotech community in the country is also a hindrance. Q What will be your priority for reaching out to them? It is necessary to see how the entrepreneurs have moved in this area. Reaching out to the industry has never been an issue. There are lot many people who speak for BIRAC at different platforms. We tried to reach out to them through various means including print media, websites and put forth the best information as much as we can. The events such as grant aiding workshops, road shows, seminars and training sessions were helpful. Infact there is a large population and we need to reach out to more people. We are networking with the industry at a greater scale and the launch of BIG scheme is yet another great step in this direction. Until now there was no such investment scheme for the companies at lower level. We are trying to bring in mentorship but obviously it will take a while to get there. We are hopeful that in the years to come we would be able to achieve that. Q What is your message to the entrepreneurs? The entrepreneurs must have a clear and an open mind about the idea that they will be working on. They should also think about the idea if it is achievable or not. The idea must be sustainable and they must be ready to invest time and energy to deliver. Dr Renu Swarup has been instrumental in providing support to many innovative projects and all credits to her for generating lot of activism Dr PM Murali managing director and CEO, Evolva Biotech, president, Association of Biotechnology Led Enterprises Dr Swarup credits Dr MK Bhan, secretary of DBT, for having envisaged the goals that are unique to the core. She proudly points to that fact there is no model like BIRAC anywhere in the world. â€œI received overwhelming support from my colleagues and industry experts in taking this calculated risk. The Biotech Consoritium India Ltd (BCIL) was a great partner and the way they handled the logistics and administration was awesome, because of which we got ample time for the technical nitty gritty for the new organization. It never happens anywhere that a programme like BIRAP, that was a unique pilot project gets converted into a full fledged company. It was a moment of high excitement for me when the company was registered and it gave me immense happiness that something like this has been finally achieved. We will ensure that BIRAC operates as an organization which will act as a connector and catalyzer,â€? says the an enthused Dr Swarup with a visible bright smile. Having received close to 70 crore operational budget initially, BIRAC under the leadership of Dr Swarup has been allocated a budget of 150 crore this financial year. Having supported seven projects, the response has been good so far. Now the wait is on. â€œAmong other verticals, we are also interested in taking up the green technology projects and international technological collaborations. We look ahead to create a biotech innovation enterprise which is at par with the global best,â€? she adds with confidence in her voice. Nurturing the seeds of innovation Dr Swarup was also instrumental in supporting the creation of new incubators that received overwhelming support from the universities and colleges. However, Dr Swarup admits being cautious in choosing the proposals as the aim was not to set up incubation units just for the sake of it. â€œWe had through our website stated clearly that the potential beneficiary must be having the existing incubator and should be involved in the business for a while. We are trying to provide the mentorship in intellectual property, tech transfer, connectivity, and awareness sessions. The idea is to make them functional and not just creating another lab spaceâ€?, says Dr Swarup. "She has helped in cementing ties between industry and academia. Her convincing skills are exemplary" Dr Chetan Chitnis principal investigator, Malaria Group, International Centre for Genetic Engineering and Biotechnology Talking further about the relevance of public private partnerships and the role played by DBT, Dr Swarup says, â€œAcademia feels confident when they come to industry through DBT. They know that we are behind them to take care of their interests including the intellectual property issues. The second reason is that they might not be well conversant with the technical knowledge. They don't have that background.â€? She was also a member of the task force on women in science constituted by the scientific advisory committee to the prime minister. On being asked about encouraging more women in this domain, Dr Swarup agrees that women must be encouraged to take up research. However, she is of the opinion that it is the quality and outcome of research that is very important and it must not be compromised at any cost. â€œThey should perform well and shine. I worked in a team and as a woman it is always relaxing to see more and more of them coming into this field. But they have to work shoulder to shoulder with men and be equally talented to deliver.â€? "Dr Swarup has been doing quite a good job at DBT. Her role in initiating various new projects and their execution has been simply great" Supreet Deshpande CEO, V Life Sciences Currently Dr Swarup is busy with the Social Innovation Scheme for affordable healthcare which is to be launched by April, 2013. Dr Swarup finds it difficult to pin point a particular project as her achievement. â€œI have an advantage as my portfolio is diverse right from the tissue culture, industry partnerships, microbial research, public private partnership, and energy which was my idea. I enjoyed working on creating a roadmap for three bioenergy centres. The launch of ignition grant was very satisfying, yet it is difficult to choose one and say this was the best.â€? Born in Ahmedabad (Gujarat), Dr Renu Swarup belongs to a family of defense people. She got to travel across India as her father was serving in the army. Owing to her busy schedule, she seldom gets time to enjoy her dearest hobby of reading books. Rahul Koul ]]> <![CDATA[The beacon off innovation]]> https://biospectrumindia.com/news/95/1356/the-beacon-off-innovation.html https://biospectrumindia.com/news/95/1356/the-beacon-off-innovation.html Mon, 10 Dec 2012 13:04:00 +0530 Dr Renu Swarup adviser, Department of Biotechnology and managing director, Biotechnology Industry Research Assistance Council (BIRAC) Coming from the defence lineage, this disciplined and strong willed lady, who holds an overseas postdoctoral degree, is driving innovations in the biotech industry through the funding schemes thereby providing support for this niche and upcoming sector A passion for taking up challenging assignments in new fields motivated Dr Renu Swarup, a young lady with doctorate degree in genetics and plant breeding and post-doctoral research at The John Innes Centre, Norwich UK, to join a small team of over 20 people at the Department of Biotechnology (DBT), which was a spinoff from Department of Science and Technology and was just three years old then in 1989. From then on, there is no looking back for the lady who has spearheaded many initiatives, projects and programs on different topics at the DBT. During her career span of 23 years she has initiated many â€œfirstsâ€? at the department such as - the first centre for plant biotechnology at National Chemical Laboratory (NCL) at Pune. She was the part of the team that brought out 60 forestry regulation protocols for 10 million plants. Her role in the establishment of Lucknow Biotech Park, also has been exemplary, for which the then Prime Minister, Mr Atal Bihari Vajpayee, who incidentally represents Lucknow constituency in Parliament laid the foundation in 2003. Besides being a senior advisor to DBT, currently Dr Renu Swarup has been heading a new initiative of the department - Biotechnology Industry Research Assistance Council (BIRAC), a not-for-profit section 25 company of Government of India, set up with the idea to serve as a single window for emerging biotech industry as its first managing director. Dr Swarup played a key role in getting the new organization created and making it operational. The company successfully runs a large number of funding schemes for industry innovation, ranging from the ignition grant to proof of concept funding, validation and product development. The main focus of the organization is on enabling and supporting the biotech innovation ecosystem. The company is mandated to take discovery forward and encourage the product development by indigenous biotechnological companies. Dr Swarup considers herself fortunate enough to have worked on the programs such as Small Business Innovation Research Initiative (SBIRI) and Biotechnology Industry Partnership Program (BIPP). These programs were established to support innovation at the level of discovery upto the clinical stage. â€œWhen we started these programs long back, our vision was to have a futuristic programs for creating better options to meet the societal needs in the long run. I am proud to say that out of hundreds of projects supported by us so far, about 10 to 11 innovations have qualified for further development.â€?  Promoter of new initiatives  With promoting new ideas high on her agenda, Dr Renu Swarup has played a key role in new initiatives such as Biotechnology Industry Research Assistant Program (BIRAP) and Biotechnology Industry Partnership Program (BIPP), Energy Bioscience, Bioresource and Bioprospecting, Biotech Park Lucknow, and Epromis Application at DBT. She has also been closely involved in programs and activities related to women and science. She was responsible for implementation of DBT Scheme on Biotechnology Career Advancement for Women Scientists - BioCARe. She also promoted National Certification System for Tissue Culture Raised Plants (NCS-TCP) under Indo-Australia Biotechnology Program. DBT-TWAS Biotechnology Fellowship Scheme, BIOCARE Research Competitive Grant Fellowship and Career Research fellowship Donning the director's hat Recalling the initial discussions on creation of a program aimed at fostering innovation in the country in 2005, Dr Swarup, who was a part of the discussions held between the various stakeholders including industry experts, financial, legal and venture specialists, said, â€œWe came up with an announcement of strategy consultation amidst many ministries involved in the exercise. It was really a challenge for us to create a unique philosophy for a new organization and also ensure that it is not a copy of DBT and just complements the work of the former. That's when we authorized the Indian Institute of Management, Ahmedabad to prepare a report to find out what would be best for an organization that nurtures innovation. That resulted in the creation of Biotechnology Industry Research Assistance Program (BIRAP), a program to nurture innovation. Finally, in April 2012, it was incorporated as a section 25 public sector company known as BIRAC by the government of India to nurture and promote innovation research in the biotech enterprise with special focus on start-ups and SMEs.â€? 'We are here to instill confidence in entrepreneurs' Q What is stopping scientists to turn entrepreneurs in the biotech space? We definitely need to instill confidence in the new comers in the industry. We need to find out the reason why more scientists are not willing to turn into entrepreneurs and what is the actual barrier stopping them. We know that something is restricting them and the financial conditions might be one of the reasons along with the level of education and awareness. The lack of enough mentors and role models for the biotech community in the country is also a hindrance. Q What will be your priority for reaching out to them? It is necessary to see how the entrepreneurs have moved in this area. Reaching out to the industry has never been an issue. There are lot many people who speak for BIRAC at different platforms. We tried to reach out to them through various means including print media, websites and put forth the best information as much as we can. The events such as grant aiding workshops, road shows, seminars and training sessions were helpful. Infact there is a large population and we need to reach out to more people. We are networking with the industry at a greater scale and the launch of BIG scheme is yet another great step in this direction. Until now there was no such investment scheme for the companies at lower level. We are trying to bring in mentorship but obviously it will take a while to get there. We are hopeful that in the years to come we would be able to achieve that. Q What is your message to the entrepreneurs? The entrepreneurs must have a clear and an open mind about the idea that they will be working on. They should also think about the idea if it is achievable or not. The idea must be sustainable and they must be ready to invest time and energy to deliver. Dr Renu Swarup has been instrumental in providing support to many innovative projects and all credits to her for generating lot of activism Dr PM Murali managing director and CEO, Evolva Biotech, president, Association of Biotechnology Led Enterprises Dr Swarup credits Dr MK Bhan, secretary of DBT, for having envisaged the goals that are unique to the core. She proudly points to that fact there is no model like BIRAC anywhere in the world. â€œI received overwhelming support from my colleagues and industry experts in taking this calculated risk. The Biotech Consoritium India Ltd (BCIL) was a great partner and the way they handled the logistics and administration was awesome, because of which we got ample time for the technical nitty gritty for the new organization. It never happens anywhere that a programme like BIRAP, that was a unique pilot project gets converted into a full fledged company. It was a moment of high excitement for me when the company was registered and it gave me immense happiness that something like this has been finally achieved. We will ensure that BIRAC operates as an organization which will act as a connector and catalyzer,â€? says the an enthused Dr Swarup with a visible bright smile. Having received close to 70 crore operational budget initially, BIRAC under the leadership of Dr Swarup has been allocated a budget of 150 crore this financial year. Having supported seven projects, the response has been good so far. Now the wait is on. â€œAmong other verticals, we are also interested in taking up the green technology projects and international technological collaborations. We look ahead to create a biotech innovation enterprise which is at par with the global best,â€? she adds with confidence in her voice. Nurturing the seeds of innovation Dr Swarup was also instrumental in supporting the creation of new incubators that received overwhelming support from the universities and colleges. However, Dr Swarup admits being cautious in choosing the proposals as the aim was not to set up incubation units just for the sake of it. â€œWe had through our website stated clearly that the potential beneficiary must be having the existing incubator and should be involved in the business for a while. We are trying to provide the mentorship in intellectual property, tech transfer, connectivity, and awareness sessions. The idea is to make them functional and not just creating another lab spaceâ€?, says Dr Swarup. "She has helped in cementing ties between industry and academia. Her convincing skills are exemplary" Dr Chetan Chitnis principal investigator, Malaria Group, International Centre for Genetic Engineering and Biotechnology Talking further about the relevance of public private partnerships and the role played by DBT, Dr Swarup says, â€œAcademia feels confident when they come to industry through DBT. They know that we are behind them to take care of their interests including the intellectual property issues. The second reason is that they might not be well conversant with the technical knowledge. They don't have that background.â€? She was also a member of the task force on women in science constituted by the scientific advisory committee to the prime minister. On being asked about encouraging more women in this domain, Dr Swarup agrees that women must be encouraged to take up research. However, she is of the opinion that it is the quality and outcome of research that is very important and it must not be compromised at any cost. â€œThey should perform well and shine. I worked in a team and as a woman it is always relaxing to see more and more of them coming into this field. But they have to work shoulder to shoulder with men and be equally talented to deliver.â€? "Dr Swarup has been doing quite a good job at DBT. Her role in initiating various new projects and their execution has been simply great" Supreet Deshpande CEO, V Life Sciences Currently Dr Swarup is busy with the Social Innovation Scheme for affordable healthcare which is to be launched by April, 2013. Dr Swarup finds it difficult to pin point a particular project as her achievement. â€œI have an advantage as my portfolio is diverse right from the tissue culture, industry partnerships, microbial research, public private partnership, and energy which was my idea. I enjoyed working on creating a roadmap for three bioenergy centres. The launch of ignition grant was very satisfying, yet it is difficult to choose one and say this was the best.â€? Born in Ahmedabad (Gujarat), Dr Renu Swarup belongs to a family of defense people. She got to travel across India as her father was serving in the army. Owing to her busy schedule, she seldom gets time to enjoy her dearest hobby of reading books. Rahul Koul ]]> <![CDATA[JEEV Infusing life into humanity]]> https://biospectrumindia.com/news/95/2149/jeev-infusing-life-into-humanity.html https://biospectrumindia.com/news/95/2149/jeev-infusing-life-into-humanity.html Thu, 06 Dec 2012 20:34:00 +0530 JEEV Working on Intercell AG's technology platform for seven years, Biological E, one of the leading Indian vaccine manufacturers, has launched a safe and effective vaccine against Japanese Encephalitis, a deadly infectious disease and the leading cause of Acute Encephalitis In 2005, Uttar Pradesh and neighboring Nepal witnessed death of over 1200 children during an epidemic outbreak of Japanese Encephalitis (JE), a deadly infectious disease found mainly in Asia. This deadly viral disease is the leading cause of Acute Encephalitis Syndrome (AES). The situation continues to remain the same even today. There were more than 8,000 confirmed cases recorded in India in 2011 with over 1100 death cases. JE is known for high mortality (upto 35-40 percent) and high morbidity, where upto 50 percent of all survivors end up with physical and mental disabilities after surviving the disease. There is no specific treatment available for JE and vaccination is the most effective weapon against the disease. Inactivated vaccines are considered to have a better safety profile as compared to live vaccines. Currrently, there is no other vaccine available to private doctors in India. Since there was no life saving vaccine available in the market for such a deadly viral disease, Biological E, one of the leading Indian vaccine manufacturers based at Hyderabad and having served the community for close to five decades decided to work in this area. Biological E started exploring for suitable technology to reduce the product development timelines and as the outcome in 2005, it signed a technology partnership agreement with the Austrian vaccine and biotechnology company, Intercell AG for the development, manufacturing, marketing and distribution of JE vaccine in India and in the Indian subcontinent. Dr T Jacob John, India's eminent pediatrician and virotlogist at the launch of JEEV The availability of a safe and effective vaccine against JE is indeed good news for families and pediatricians in all JE endemic states of India. - Dr T Jacob John Intercell AG has a technology whose base includes novel platforms, such as the patch-based delivery system and the proprietary human monoclonal antibody discovery system eMAB, in addition to well-established technologies upon which the company has entered into strategic partnerships with a number of leading pharmaceutical companies, including GSK, Merck, Novartis and Sanofi. Using this technology Biological E has developed a vaccine against JE after seven years of in house R&D effort and support from its technology partner, Intercell AG. This vaccine is a second generation inactivated Japanese Encephalitis vaccine based on the SA 14-14-2 strain and does not contain any gelatin stabilizers or thimerosal and the vaccine's safety and efficacy has been established through multiple studies on Indian subjects and is also licensed by the Drug Controller General of India. Biological E launched its inactivated Japanese Encephalitis vaccine marketed under the brand name â€œJEEVâ€?, in the domestic private market at price of 985 per 0.5ml vial. The vaccine is approved for immunization against JE for both pediatric and adult subjects. USP of JEEV Second generation inactivated vaccine based on the SA 14-14-2 strain Does not contain any Gelatin stabilizers or Thimerosal Safety and efficacy of the vaccine has been established through multiple studies on Indian subjects Intercell's vaccine against Japanese encephalitis, which formed the basis for the technology transfer to Biological E, is licensed by the United States Food and Drug Administration, European Medicine Agency and multiple countries like Australia, Canada, and Switzerland. Big boost from government The government of India is making efforts to prevent and control of JE and AES. In this regard, the Union Cabinet on October 18, 2012 has approved a proposal for a comprehensive, multi-pronged strategy to be implemented in 60 priority districts for a period of five years from 2012-13 to 2016-17 by the Ministries of Health and Family Welfare, Drinking Water and Sanitation, Social Justice and Empowerment, Housing and Urban Poverty Alleviation, and Women and Child Development. Focused interventions will be done in five states namely Assam, Bihar, Tamil Nadu, Uttar Pradesh, and West Bengal. The major activities include public health interventions, expansion of JE vaccination, improved case management, medical and social rehabilitation, improved provisions of drinking water and sanitation in rural and urban areas, and improved nutrition â€œThe availability of a safe and effective vaccine against JE is indeed good news for families and pediatricians in all JE endemic states of India. Very much like polio, JE is also a low frequency but high impact disease. When 200 children get infected with poliovirus, one gets polio; when 300 children get infected with JE virus, one gets encephalitis. Polio paralyses but JE kills and causes brain damage in those who survive. Vaccine will enable families to take responsibility to protect their children. I congratulate Biological E for launching a high quality vaccine in India,â€? said Dr T Jacob John, India's eminent pediatrician and virologist who presided over the product launch on September 13, 2012. â€œWith the launch of JEEV, the indigenous vaccine with excellent safety profile and proven efficacy in Indian subjects is now available to doctors for prevention of Japanese Encephalitis in children and adults, â€œsaid Dr Vijay Kumar Datla, chairman and managing director of Biological E. The chief executive officer of Intercell AG, Mr Thomas Lingelbach said, â€œOur strategic partnership with Biological E has supported us in taking a major step forward in achieving our goal of rolling-out this JE vaccine in endemic countries with a high medical need in order to protect children and adults against this terrible disease. Now, we will continue to fight against this disease and collaborate on increasing market penetration in the endemic region.â€? The product development team of JEEV at Biological E There is no other JE vaccine currently in the private market and JEEV is the only vaccine available. The Government of India imports a live attenuated vaccine from China for public immunization. JEEV is a second generation inactivated cell culture vaccine against JE. Considering the need and gap in the market, Biological E is focusing on its sales efforts of JEEV initially on private market customers including pediatricians and general practitioners. To ensure a successful product launch, Biological E has recruited and trained its own sales force, which will initially be fully dedicated to the product. The company plans to offer the vaccine as a safer and indigenous alternative to the government for JE campaigns. Biological E has also submitted the data for JEEV as part of the WHO prequalification process and will aim for export markets on completion of the WHO prequalification process for JEEV. The approval will enable the vaccine to be exported to global agencies. Meanwhile, many developing countries are showing their interest in its JE vaccine. ]]> <![CDATA[An accidental entrepreneur]]> https://biospectrumindia.com/news/95/1836/an-accidental-entrepreneur.html https://biospectrumindia.com/news/95/1836/an-accidental-entrepreneur.html Thu, 06 Dec 2012 20:30:00 +0530 Mr Shrikumar Suryanarayan chairman, Sea6 Energy At 23, he joined Biocon and directed its R&D ethos and enzymes conquest spiritedly; At 52, with the same raft of energy and agility, he's etching a pioneering entrepreneurial story which has the potential to change the energy ecosystem. This craftsman, who permutes between the industry and academia with ease, is doing remarkable things in a remarkable way Applied research was always his area of interest and he was fascinated by chemistry. In an era, when being a doctor or an engineer was the trend, he opted for chemical engineering at IIT Madras as the subject was close to his heart. He also did not flow with the tide of going and working abroad or pursing a career in established companies. He listened to his heart and chased his dreams-first with Biocon and now as chairman of Sea6 Energy. Shrikumar Suryanarayan or â€œShriâ€?, as the world knows him, calls himself an accidental entrepreneur; but all his friends and colleagues say he is an entrepreneur at heart and his new venture, Sea6 Energy is pioneering and is potentially transformational in the alternate energy space. â€œHe has not lost his youthful exuberance and his zest for scientific innovation, both of which will steer him to success. I am sure he will not only make me proud but the country proud by realizing his dream of converting seaweed into bioenergy,â€? stated Ms Kiran Mazumdar-Shaw, chairman and managing director, Biocon. His young colleagues at Sea6 Energy are moved by his exuberance and passion. â€œA great quality about Shri which can never go unnoticed is his enthusiasm and passion for everything he does which makes interacting with him an amazing experience,â€? says Ms Sowmya Balendiran, co-founder, manager, Operations, Sea6 Energy. His infectious energy inspires everyone around him to put in their best efforts. â€œCoupled with this is his ability of getting together the right group of minds from diverse fields to solve any challenge, no matter how complex,â€? tells Mr Nelson Vadassery, co-founder and manager, Technology and Engineering, Sea6 Energy. Shri was always interested in the interface of biology and chemistry. He was drawn towards the plausible energy crisis as early as 1982 and explored projects in alternative energy. And it was during his undergraduate days at IIT Madras that Shri got introduced to Ms Shaw and Biocon in Bangalore, where his parents lived. "Shri has mastered the ability to understand people and their perspectives which makes him such a good leader.No matter how dreary the circumstances, Shri has always been able to focus on the brighter side of things and bounce back unfailingly. Knowing him has been one of the most enriching experiences of my life. He has been a great mentor, a good friend and a wonderful human being" Ms Sowmya Balendiran, co-founder, manager, Operations, Sea6 Energy The meeting was interesting relives Shri. â€œThe learning culture at IIT Madras was to observe and ask questions and be connected with the industry.â€? He thoroughly cherished this process of knowledge acquisition. And during one of his visits to Bangalore, he saw enzymes on the shelves of Biocon. The company was operating out of Cunningham Road in Bangalore. He approached Ms Shaw to buy some enzymes for his project. Biocon was very small and Ms Shaw probably was hoping to bag a major order from IIT Madras where Shri was studying. On the contrary, he needed only a few grams of enzymes and told Ms Shaw that he would pay from his pocket. He thereafter left to IIT Madras and was surprised when he received a parcel at his hostel canteen. It was a parcel of enzymes sent by Ms Shaw and what struck him was a small, but magnanimous note from Ms Shaw stating that she was giving him the enzymes for his project and he needn't pay for the same. This action set the connect between Shri, Ms Shaw, and Biocon. "Ever since I've known Shri, I've seen him to be the very embodiment of enthusiasm. Working with him has been an enriching experience, both on a professional and personal level" Mr Nelson Vadassery co-founder and manager, Technology and Engineering, Sea6 Energy Soon after Shri completed his BTech, he went to do his masters in biochemical engineering at IIT Delhi. And he met Ms Shaw again during this period to seek her guidance and references for the next phase of his career. This was the time that Ms Shaw was planning to set up a R&D campus and she asked Shri to join Biocon. She took Shri to the new proposed site to acquaint him about the facility and convince him to join Biocon. What impressed Shri during the visit was Ms Shaw's impromptu instructions to the construction engineers at the site. He was attracted by her eye for detail and aesthetic approach to even minuscule things. â€œI joined Biocon because of the color of the tiles,â€? recounts Shri on a lighter note. â€œR&D those days was for tax breaks. Yet it was fun. It was an era when microbiology wasn't fast and the computers were just coming in,â€? says Shri. So he became an IT manager, built a payroll system, and did a lot of other things. Life was fun and exciting. He recollects how he borrowed money for buying a computer for Biocon on Ms Shaw's suggestion to raise loan from his grandfather to buy a computer. He was instrumental in developing several processes for production of industrial enzymes, invented novel bioreactor for Solid State Fermentation, alongst other things during his over two-decade association with Biocon. He was always the head of R&D. He says jokingly to Ms Shaw that he was never promoted. "Shrikumar embodies true spirit of an innovator and entrepreneur, and Sea6 Energy in pursuit of a bold, challenging idea describes him well" Dr MK Bhan secretary, Department of Biotechnology, Government of India â€œShri is a remarkable scientific technologist. I first engaged with him in 1980s as a student of Chemical Engineering from IIT Madras and found that we shared a mutual passion to innovate in the realm of biotechnology. His highly creative bent of mind was most impressive and the moment he graduated from IIT, I persuaded him to lead our R&D efforts at Biocon in 1983. Shri played a strong leadership role in Biocon's innovation-led enzymes business evolution for over 25 years,â€? says Ms Shaw. Sea6 Energy Shri stepped down from his administrative role of president of R&D at Biocon in 2007 to pursue his personal interests in public health, bioenergy and education and taught at his alma matter, IIT Madras. "It is indeed remarkable that Shrikumar, after spending many years as the head of R&D in Biocon decided to enter the stormy world of a start-up venture. His idea of utilizing seaweeds as an energy crop is indeed a brilliant one as it does not place any demands on the ever diminishing arable land nor does it compete with food crops in meeting the growing renewable energy needs of the world" Dr KK Narayanan managing director, Metahelix Life Sciences Shri was intensely looking out for the next problem in the application of biotechnology to solve when some students at the institute reached out to him. They requested Shri to help them with their project on â€œStress Kitâ€? to enter the the iGEM 2008 competition of the Massachusetts Institute of Technology (MIT) in the US. They were selected for the final round and had to go to MIT for making the presentation. But they couldn't go to the US as they were denied a visa. Yet they won a prize after making a video presentation from India. It was because of their passion, sheer persistence, enthusiasm, and dynamism that they won the iGEM 2008 competition. â€œThey were brilliant and passionate and I wanted to some how tap their potential. That is how we all came together,â€? remarks Shri. Shri strongly believes that we will always be short of land and we have to think for solutions that would not get caught on the food versus the fuel debate. â€œWe need to capture energy from the sea.â€? Shrikumar got them interested in the area of algal biofuels. They attended several algal biofuel conferences and spent the last two years of their MTech investigating the potential of algae biofuel. â€œThe group spent more than 18 months working on the engineering framework of microalgae,â€? explains Shri. They were almost about to abandon the project as they realized that they were going after an unmanageable idea. The challenge was that algae needs significant amounts of fresh water, large nutrient inputs and plenty of land and it would take several years to crack the code to make it economically viable. "Thanks to his infectious charm, we built a very creative team of scientists and engineers who helped Biocon build a strong global reputation in enzyme technology. Under his able stewardship, Biocon built an impressive patent portfolio which included a novel platform technology - the Plafractor, which received a worldwide patent for the production of both enzymes and pharmaceuticals. Shri also spearheaded a number of novel enzyme development programs, many of which were globally commercialized. The highly innovative and specialized enzyme portfolio and Shri and his R&D team developed translated into huge market value for Biocon which was realized when the enzymes business was divested to Novozymes, the Danish enzymes giant. Shri stepped down from his leadership role as the president R&D from Biocon when the company decided to move its business orientation towards biopharmaceuticals. Shri is an entrepreneur at heart and his new venture Sea6 Energy is pioneering and potentially transformational in the alternate energy space. I am very favorably inclined with Sea6 Energy's biofuels innovation model. I do believe that this is very interesting renewable energy business model" Ms Kiran Mazumdar-Shaw chairman and managing director, Biocon When they had finished their master's degree and were beginning to disperse, somebody from the group thought of seaweed (macroalgae) as an alternative. The seaweed, according to Shri, has inherent advantages and appears to be an attractive proposition as biofuel feedstock, as the seaweed grows in shallow ocean waters and doesn't need land, water or nutrients since the ocean itself provides them. There were about three labs working on macroalgal biofuel at that time-Bio Architecture Labs the Korean Institute of Industrial Technology and the Philippines government. Shri was able to convince several members of his prized iGEM 2008 team (Mr Nelson Vadassery, Mr Sayash Kumar, and Ms Sowmya Balendiran) to stay back to start Sea6 Energy and focus on macro algae route to biofuels. Thus Sea6 Energy was incubated in July 2010 at IIT Madras campus. Shrikumar and a few IIT Madras alumni contributed about 1 crore to get the company started. Ever since the day Sea6 Energy was formed, the team has achieved several milestones. Starting with the scientific possibility of growing plants on sea and finding the right plants, the stage is now set for technical feasibility. It has also developed technology to allow farmers to grow seaweed in deep waters. They have built a 4,000 sqft farm to grow seaweed and convert seaweed to ethanol. The process for this has been identified. The company's next phase is to move from technical feasibility to commercial viability. It has identified the key enzymes. It plans to build 1sqkm of ocean farm and demonstrate that biofuel can be commercially produced. It plans to achieve this around 2015-2016. It has also entered into a tie up with Novozymes to explore enzymatic technology to produce fuel ethanol, fine chemicals, and protein from seaweed. Novozymes will research, develop, and manufacture enzymes for the conversion process, while Sea6 Energy will contribute its offshore seaweed cultivation technology. It recently raised over 3 crore. Shri is a passionate man and has a great support from his family. He has two daughters and both of them are pursuing their higher education abroad. His wife, a gynecologist, is today actively championing the cause of building value systems in children through Enfold Proactive Health Trust, an NGO. â€œTeam is the most important part of building a great organization,â€? concludes Shrikumar. Srinivas Rao Chandan and Narayan Kulkarni ]]> <![CDATA[Debate on compulsory licensing continues..]]> https://biospectrumindia.com/news/95/2199/debate-on-compulsory-licensing-continues-.html https://biospectrumindia.com/news/95/2199/debate-on-compulsory-licensing-continues-.html Thu, 08 Nov 2012 16:58:00 +0530 Though WTO has flexibilities in TRIPS agreement to increase access to medicines, a debate on issuing compulsory licensing continues in India, with stakeholders pointing out that the governing agency should prudently decide as to how and when to use this provision When the Indian patent office granted compulsory license to Hyderabad-based Natco Pharma to market the generic version of a patented cancer treatment drug, Nexavar in March this year, it was not the first nation to do so. In last 10 years, governments of the developing nations such as Zimbabwe (2003), Malaysia (2003), Zambia (2004), Indonesia (2004 and 2007), Thailand (2006 and 2007) and Brazil (2007) have already evoked compulsory licensing to increase their access to medicines. Even after six months of issuing compulsory licensing by the Indian government, it still remains as a subject of debate in many forums and conferences in India. India never felt the need to issue compulsory licensing since 2005, as it didn't face a situation that has demanded the use of this provision until 2012. However, Mr YH Gharpure, Gharpure Consulting Engineers, Pune, opined, â€œThere is a provision in the patent act for government to evoke compulsory licensing under clause 100 as has been done by Brazil government, thereby forcing the multinationals (MNCs) either to reduce the exorbitant prices of the patented drugs or the government take recourse to compulsory licensing and give the same to several companies so that essential drugs are available at reasonable prices.â€? Elaborating on compulsory licensing, Mr Kirit S Javali, Partner, Jafa & Javali, Advocates, New Delhi pointed out that, â€œThe grant of a patent confers limited monopoly on the patentee to the exclusion of others. Though the law permits this, it also takes into account the fact that the monopoly granted through a patent may be abused and hence, provides for certain restrictions to its enjoyment. The grant of compulsory licence is one such restriction imposed on the absolute exploitation of a patent.â€? Use of compulsory licensing and government use by developing countries Date County Product Duration Royalties Apr 2003 Zimbabwe all HIV/AIDS - related Medicines not indicated not indicated Oct 2003 Malaysia didanosine, zidovudine, FDC didanosine + zidovudine two years not indicated Sep 2004 Zambia FDC lamivudine + stavudine + nevirapine until notification of expiry of the compulsory license 2.50% Oct 2004 Indonesia lamivudine, nevirapine 7-8 years (end patent term) 0.50% Nov 2006 Thailand efavirenz until 31 December, 2011 0.50% Jan 2007 Thailand lopinavir/ritonavir until 31 January, 2012 0.50% Jan 2007 Thailand clopidogrel patent expiry or no longer needed 0.50% Mar 2007 Indonesia efavirenz until 07 August, 2013 0.50% May 2007 Brazil efavirenz five years 1.50% Source: www.moph.go.th Sharing his thoughts on the topic, Mr KV Balasubramanian, managing director, Indian Immunologicals, Hyderabad said, â€œIndia amended its patent act in 2005. Even before, compulsory licensing was there in place, but was not evoked. For any society, where people are unable to meet up with their daily requirements, compulsory licensing would bring in cheer on their faces as the healthcare costs are beyond their reach. India granted its first ever compulsory licensing to Natco Pharma only this year. Thailand and many developing nations have already granted compulsory licensing to overcome the monopoly in the market. If I am not wrong, even developed nation such as Canada has used compulsory licensing earlier.â€? The spokesperson from Sun Pharmaceutical remarked, â€œMost countries have some form of compulsory licensing or similar provision to protect the interest of the patient, which itself seems like a reasonable thing. Having said that, it may be too early as yet to see how this has impacted the society-there have not been too many instances of compulsory licensing being granted.â€? Why compulsory licensing? In India, the provisions on compulsory licensing were introduced into the Patents Act pursuant to the recommendations by the Ayyangar Committee. The predominant purpose behind the grant of a compulsory license is to ensure the supply of the patented invention in the Indian market. Patents are not granted to enable the patentee to enjoy a monopoly by importing the patented articles into India. â€œThe Patents Act makes the working of the invention in India an important requirement. At the same time, the effort expended by the patentee in inventing the patented article, the expenditure incurred in research and development, and in obtaining and keeping the patent in force cannot be disregarded. The provisions on compulsory licensing endeavors to secure that the articles manufactured under the patent shall be available to the public at the lowest prices consistent with the patentees deriving a reasonable advantage from their patent rights,â€? states Mr Kirit S Javali, partner, Jafa & Javali, Advocates, New Delhi. â€œAs the patent regime came in full force under World Trade Organization (WTO) from 2005, the MNCs started registering patents for a large number of new drugs, importing the products and marketing them in India without working the patent,â€? says Mr Y H Gharpure of Gharpure Consulting Engineers, who has been studying the compulsory licensing issue. â€œIf the patent is not working for three years, the compulsory licensing provision can be evoked as was done by Natco Pharma. There is a case for evoking such provisions for many other patented products for treatment of cancer, HIV/AIDs, etc. This, however, will become apparent if the information patentee files to the patent authorities under form 27 is made public. This will clearly reveal whether the patent is being worked in India or otherwise. Currently, although the information is available on request, it is not available in public domain,â€? he adds. â€œCompulsory licensing works as a double edged sword,â€? said Dr Ajay Kumar Sharma, associate director, pharma and biotech, healthcare practice, Frost & Sullivan, South Asia & Middle East and added, â€œIt helps the patent products to become more affordable and accessible in order to save lives. Thus helping the society at large. But if one has to analyze, in the long run, it deprives the innovator companies from making money, which they would have invested in discovering this successful drug and many unsuccessful trials. Also this money helps them to generate a surplus amount for funding future research which can be of immense use to mankind to fight newer disease challenges. By awarding compulsory licenses (on impulse) we are destroying this natural market equilibrium. Hence, the best way in such case would be that, the government chips in its share in providing these essential medicines at subsidized rates to the population at large rather than destroying the market equilibrium under the guise of compulsory licensing.â€? Ms Sunita K Sreedharan, partner, SKS Law Associates, New Delhi, said, â€œIn areas like healthcare, patented inventions appear to evoke high emotional content. In case of epidemics, the Patent Act provides for government intervention. In a routine system, the Drug Price Control Order can be used to control price without resorting to grant of compulsory licensing. Similarly, companies holding the patents can be encouraged to make the patented drugs available to the afflicted patients belonging to the poorer sections of the society through CSR (Corporate Social Responsibility) programs that can be implemented for a certain time period, failing which the compulsory licensing can be granted.â€? WHO supports measures to improve access to essential medicines A report titled â€œImproving access to medicines in Thailand: The use of TRIPS flexibilitiesâ€? prepared by a team of seven experts from World Health Organization (WHO), United Nations Development Program, United Nations Conference on Trade and Development, WHO South East Asia Regional Office led by Dr German Velasquez, made the following four remarks after visiting Bangkok in 2008 and holding discussions with stakeholders aimed at facilitating an understanding of the context and circumstances related to the granting of compulsory licences in Thailand, and identifying the appropriate technical and policy support required on the use of TRIPS flexibilities. In seeking greater access to essential medicines, national authorities may consider the full range of mechanisms available to contain costs of essential medicines and examine how the various tools may complement one another. A sustainable system for the funding of medicines could be based on three main components: 1) the creation or enhancement of a national or social health insurance or of medicine prepayment mechanisms. 2) the introduction and use of all possible cost-containment mechanisms. 3) the use of TRIPS-compliant flexibilities. The TRIPS Agreement contains a range of mechanisms and options to protect public health that countries can consider when formulating intellectual property laws and public health policies. The use of compulsory license and government use provisions to improve access to medicines is one of the several cost-containment mechanisms that may be used for patented essential medicines not affordable to the people or to public health insurance schemes. WHO supports measures which improve access to essential medicines, including application of TRIPS flexibilities. Source: www.moph.go.th â€œWe believe that while some developing countries may use compulsory licensing provisions in certain limited circumstances, compulsory licensing cannot address the underlying issues of access to medicines and healthcare. Systematic issuance of compulsory licenses sets a negative precedent and can reduce the incentive to invest in the research and development of new medicines. Pfizer is committed to applying science and our global resources to improve health and well-being at every stage of life,â€? commented spokesperson from Pfizer. Echoing similar sentiments, Mr KV Balasubramanian of Indian Immunologicals pointed out, â€œThe governing agency could issue compulsory licensing after proper examination and considering many aspects such as need, urgency and affordability. Otherwise, decision based on only technical aspects will open up the matter for a debate. A core committee comprising ministry of health, scientists with different back grounds should take the decision based upon situations and need instead of patent office judging the case purely on technical matters. Then only it will serve the purpose of granting the compulsory licensing to improve the access of essential medicines.â€? 'Issuing of CL will not expand access even at reduced prices' The Compulsory licensing (CL) provisions in the Indian Patents Act are basically in consonance with the TRIPS Agreement. However, provisions in the Indian CL law regarding pricing, local working, in OPPI' s view go beyond what is provided in the TRIPS Agreement and the Doha Declaration, and are not in line with India's obligations as a WTO member. We believe the government can achieve its objectives for patients through collaboration without the uncertainty that arises from unilateral actions taken on compulsory licensing. In those instances where collaboration does not prove to be a fruitful approach, developing countries like India may make use of compulsory licensing as a last resort. However, the issuance of compulsory licenses to address pricing or budget constraints could come at a long-term cost, limiting important incentives for research and development that are necessary to positively impact the lives of millions of patients worldwide. Issuing of compulsory licenses will not significantly expand access as even at reduced prices generics are out of reach for the poor in India. Once we have the right ecosystem in place, that fosters innovation, then the balancing acts with compulsory licensing on a case-by -case basis such as in times of a national health emergency could be justified. Compulsory licenses are powerful rights granted to governments to deal with the extraordinary situations. And with great power comes great responsibility. It is therefore incumbent upon those who deal with such power to ensure that these rights are exercised judiciously. - Mr Ranjit Shahani, president of the Organisation of Pharmaceutical Producers of India (OPPI), a premier association of research based international and large pharmaceutical companies in India and also the vice chairman and managing director, Novartis India, which is fighting for a patent based on increased safety of the Glivec drug due to modification of the naked chemical molecule. In all this situation, Ms Sunita K Sreedharan, concludes that the society must not lose sight of the fact that the patent system is a mere tool which can be used effectively to benefit society by bringing in technological progress or to its detriment by blocking development of technology. And in the latter context it is important to identify and block entities that use the compulsory licensing as a tool for a low-cost piggy-back ride on a research and development (R&D) company to attain bigger profits with least scientific or business efforts. An industry veteran on condition of anonymity said, â€œThe â€œlow-hanging fruitsâ€? are of the past and the diseases that affect people have become more complex. Compulsory licensing would hinder the innovation and creativity that are an integral part of drug discovery. There should be an appreciation for the years of research and billions of dollars that go into developing medicines. Pharma companies are always willing to work with the government to ensure that drugs are made affordable for the common man.â€? Narayan Kulkarni (with inputs from Manasi Vaidya) ]]> <![CDATA[The grand old innovation engine]]> https://biospectrumindia.com/news/95/1419/the-grand-old-innovation-engine.html https://biospectrumindia.com/news/95/1419/the-grand-old-innovation-engine.html Thu, 08 Nov 2012 16:53:00 +0530 While the nation's premier scientific agency, Council of Scientific and Industrial Research (CSIR) celebrated its 70th foundation day, BioSpectrum takes a look at its relevance in the bioscience industry â€œIndia matters to us, we want to matter to India, more,â€? summed up the Bangalore declaration of CSIR director's meeting in the year 1998. True to the statement, the organization today features among the world's top most publicly funded international research and development (R&D) organizations. Established in 1942 as an autonomous society and with 37 state-of-the-art institutes, CSIR holds the highest number of the US patents among all the publicly funded Indian R&D organization. Protecting intellectual property is a part of the DNA of CSIR. Its founder, Dr Shanti Swarup Bhatnagar was the first person to be granted an Indian patent during the second world war in 1941. As of January, 2012, CSIR holds 2831 foreign patents and 997 US patents granted between 2002-2011. As on March 01, 2012, the number of patents that were in force in India and abroad were 2350 and 3250 respectively. Key CSIR Institutes in Biological Sciences Centre for Cellular and Molecular Biology, Hyderabad Central Drug Research Institute, Lucknow Central Food Technological Research Institute, Mysore Central Institute of Medicinal and Aromatic Plants, Lucknow Institute of Genomics and Integrative Biology, New Delhi Institute of Himalayan Bioresource Technology, Palampur Indian Institute of Chemical Biology, Kolkata Indian Institute of Toxicology Research, Lucknow Indian Institute of Toxicology Research, Lucknow Institute of Microbial Technology, Chandigarh Indian Institute of Integrative Medicine, Jammu National Botanical Research Institute, Lucknow National Chemical Laboratory, Pune Significant Developments Pioneered DNA fingerprinting in the country Cybrids facility for the study of neurodegenerative diseases, with special reference to Parkinson's disease Advanced facility for safety evaluation of genetically engineered drugs Isolation of active compounds from native plants for the treatment of chronic myeloid leukemia and peptic ulcer The genotype 'CIM-Arogya' of Artemisia annua for higher artemisinin yield Use of recombinant viruses harbouring an RNAi construct as sensor to screen the function of each open reading frame (ORF) of viral genome An efficient method to isolate and prepare large quantities of RNAsin, an enzyme inhibitor from discarded human placenta It is interesting to know that, while CSIR constitutes only three percent of the India's scientific manpower, it still contributes about 10-11 percent of India's scientific outputs. CSIR performs research that leads in many frontiers. This is evidenced by its presence in leading journals of the world. CSIR's science also has produced new concepts that have been translated into technologies for the benefit of India. The prime minister of India, Dr Manmohan Singh in his speech on the 70th foundation day rightly called it as the flag bearer of the intellectual property movement in India. â€œAfter India introduced economic reforms and joined the world trade organization (WTO), the CSIR quickly emerged as a single largest holder of US and European patents. The Council, in recent years, has also become a world leader in specific domains of biotechnology and recombinant DNA products,â€? said Dr Singh. CSIR conducts research in frontier and multidisciplinary areas of modern biology and translates these concepts into commercially viable technologies. The thrust areas include rDNA technology, proteomics, biomarkers, nanobiotechnology, novel agro-technologies, and structural biology. The organization has played a leading role in developing the country's pharma industry by introducing innovative process technologies and new drugs. Over a dozen CSIR institutes are participating under public-private partnerships and in-house projects. The key areas of focus include studying molecular mechanisms and genetic factors of diabetes, nanomaterials and devices for health, diagnostics and target based molecular medicines, anticancer therapeutics. Through its open source drug discovery (OSDD) program, the council has made its unique attempt to make healthcare affordable and drug discovery for neglected diseases like tuberculosis malaria and leishmaniasis. In agriculture and food processing sectors, CSIR has developed globally competitive pre and post harvesting technologies for optimal production and devising necessary machinery besides enhancing the science of nutraceuticals. Major areas of research include the health foods, energy saving process and pest resistant crops. CSIR in an ongoing collaborative project with Department of Ayush is trying to document and digitize the traditional knowledge of ayurveda, unani, siddha and yoga. Known as Traditional Knowledge Digital Library (TKDL), it is expected to protect indigenous patent rights. According to Dr Samir K Brahmachari, director general CSIR, â€œThe organization will continue to look at bioscience as not only a profit making sector but a pathway towards improving human life and affordable healthcare.â€? For the next century, CSIR is expected to play a pivotal role for science in the country and be a guiding light for the bio scientists as well. S No. Patent Portfolio No. of Patents 1 Boswellic acid-anti Inflammatory, anti arthritic 5 2 Ablaquin/Mefloquin/Arteether and Artemisinin/other antimalarials 15 3 Gugulipid-Hypolipidaemic 3 4 Bacosides-Memory Plus 1 5 Vincristine/Taxol/other anti cancer agents 18 6 Saheli and other contraceptive products 5 7 Drugs and intermediates 40 8 Bio-enhancers 6 9 Anti leishmaniasis 3 10 Streptokinase 9 11 Amlodipne 5 12 Sevelamer 1 13 Salt-inducible expression vector for genetically engineered proteins 2 14 Novel cationic amphiles as transfection agents 5 15 Super oxide dismutase 3 16 DNA fingerprinting 2 17 HPLC fingerprinting 3 18 Diagnostics of eye and central nervous system 3 19 Biomaterials (Hydroxy Apetite Prosthesis Implants) 4 20 Customized Drug Response 1 21 In-silico drug target identification 1 22 Disease resistant rice variety 1 Vision CSIR 2022 ◊ Strive for global scientific impact ◊ Cybrids facility for the study of neurodegenerative diseases, with special reference to Parkinson's disease ◊ Advanced facility for safety evaluation of genetically engineered drugs ◊ Isolation of active compounds from native plants for the treatment of chronic myeloid leukemia and peptic ulcer ◊ The genotype 'CIM-Arogya' of Artemisia annua for higher artemisinin yield ◊ Use of recombinant viruses harbouring an RNAi construct as sensor to screen the function of each open reading frame (ORF) of viral genome ◊ An efficient method to isolate and prepare large quantities of RNAsin, an enzyme inhibitor from discarded human placenta Dr Manmohan Singh, Prime Minister of India I compliment CSIR for breakthroughs in advanced scientific areas that have the potential to meet the basic needs of our people Dr Girish Sahni, director, IMTECH, Chandigarh CSIR's relevance on the national scene has become even more pronounced as it is perhaps the only institution that so successfully straddles both fundamental and applications aspects of science. This is particularly so in the transformation of biological principles into biotechnology, where CSIR has already made major outstanding contributions. Mr Vayalar Ravi, former S&T minister, India CSIR has transformed itself many times; yet its all pervading spirit remains unchanged. Dedicated service to the nation and the amelioration of the conditions of citizens remains its guiding light. Young at seventy, CSIR is pursuing the quest for inclusivity in many innovative and novel ways. Dr Ch Mohan Rao, director, CCMB, Hyderabad CSIR has outstanding laboratories for chemical synthesis of new molecular entities. Our biology laboratories working with the chemical laboratories should be able to meet the challenge. However, future medicine would be largely based on cells rather than molecules. CCMB and a few other biology laboratories of CSIR are working on cell-based therapies important to our country. Dr Rajesh Gokhale, director, IGIB, New Delhi â€œWhile CSIR has supported the generic industry in past with great success and few biotech products have reached market, in this open market era CSIR is dedicated towards innovation. This includes developing New Chemical Entities (NCE), establishing novel therapeutic pipelines and setting up Biotech startups. Dr Prabuddha Kundu, executive director, Premas Biotech We at Premas, have had a very fruitful and stimulating relationship with OSDD and CSIR. The journey has been educative and interesting. Dr YK Hamied, chairman, CiplaThe joint useful and productive partnership between CSIR and the pharmaceutical industry in the post India Patent Act 1970 era has laid foundation on which was built the API manufacturing industry as it exists today. â€œRegulatory infrastructure needs to be revampedâ€? Dr Samir K Brahmachari, director general CSIR and secretary, Department of Scientific and Industrial Research (DSIR) How relevant is CSIR for bioscience industry? Are you satisfied with the progress that has been achieved?  Dr Brahmachari:  When CSIR began its journey 70 years ago, the focus at time was on chemicals, glass, minerals and steel. The first batch of CSIR labs were dedicated to chemicals. You have to accept that 50 years back biology was not considered to be a science with industrial value. It was known more as a science of intellectual pursuit. The only biology related institute founded 60 years back was Central Drug Research Institute (CDRI) Lucknow in 1951. Therefore at CSIR, it all started in 70s. It was clear that drug research has to be part of industrial value. That was echoed by Mrs Indira Gandhi's statement at World Health Organization (WHO), which mentioned healthcare research as not for profit but as a matter of life and death. After the patent regime changed, the focus shifted from product to process patents. It gave major boost to the institutes such as Indian Institute of Chemical Technology (Hyderabad), CDRI and National Chemical Laboratory (NCL), Pune. These labs played a key role in creating genesis buzz. Out of 70 drugs created, 30 came from CDRI. The areas such as family planning were prioritized when they were considered taboo. You can see that it was the genesis from chemistry to biotech. Subsequently bio related institutes got their due in 1980s. The Centre for Cellular and Molecular Biology (CCMB), Hyderabad, Institute of Microbial Technology (IMTECH), Chandigarh, and Centre for Biochemical Technology (CBT now Institute of Genomics & Integrative Biology (IGIB) started in 1977. After building expertise in toxicology, bichemstry and drugs, CSIR institutes moved towards genomics and recombinant DNA technology. The bottomline is that the CSIR has remained relevant by constantly reinventing itself to suit the nation's interest from time to time. I would say that over the period of 25 years, it has been phenomenal. We have had so many great experiences during this time and that also resulted into many products. From copying, better copying, from invention to, patented products to global best products, has been our journey. Are our research institutes innovating enough?  Dr Brahmachari:  If it is about innovating, I would say yes. We are doing it in enough quantity. But I would like to turn the question and ask whether we are inventing enough? Then answer would be in negative. Basically our inventiveness is low but our innovativeness is enough. Therefore, we have to make our science more inventive. We have to look at the situation today. Among the US patents granted today, CSIR holds 90 percent share while the other academia, industry and R&D labs have 10 percent. This is serious because CSIR has at the same time only three percent of the overall manpower. Hence, technically other should be coming up with more patents. Yet on a positive note, while our share earlier was 95 percent, it got reduced to 90 percent and then come down to 85 percent in future. With time, awareness is coming and others are catching up. How do you perceive the growth of biotech industry? How has CSIR contributed to it?  Dr Brahmachari:  The industry definitely has moved forward but I wish there would have been pure biotech companies in true sense. We don't have a single billion dollar company. Most of the biotech industry we see today is into instrument service, contract research and clinical trials. We had best examples in form of Shantha Biotech and Bharat Biotech but then these too followed similar kind of portfolios for vaccines. The diversification of portfolios should get due attention from the companies. Mere following each other won't help. Getting into new areas of technology space and development of instrumentation and high value research must be prioritized. Also the dependence on government for funding must be slowly reduced. New avenues to generate funds must be explored. Moreover, there is something amiss in our biotech education policy too. Every year we are churning our MSc graduates in large numbers without even proper knowledge of basic fundamental principles of biotech. The importance of mathematics is crucial for higher research and needs to be incorporated right from the basic level. In affordable healthcare, the entire thrombolytics drugs (which help dissolve blood clots) is an area of our research. Cardiovascular medicines are expensive and some of our innovations have helped bring down prices of injections from 8,000 to 1,000. Now we have come up with new generation drugs that only destroy the clot and do not touch anything else. That is the new bio-therapeutic that has moved to clinical trials and all that work has happened at CSIR's Chandigarh-based Institute of Microbial Technology. There are plenty of other examples to share that make CSIR's contribution to the industry a phenomenal one. How can the industry and academia be self reliant?  Dr Brahmachari:  I think the government funding has been reasonable enough but we in fact sometimes have less absorption capacity. Both academia and industry must build its capacity to survive on own and reduce dependency over the period of time. The potential philanthropic funding, new sources of foreign funding need to be explored. I think with lesser government funding, the scientist will have to perform more and will be under an obligation to show quick results. I must also add that regulatory infrastructure also needs to be revamped. The quick clearances are very important for fewer hassles in product development. Also the leaderships within academic institutes and industry have to be more dynamic in their attitude. Which are the next steps for CSIR in the area of bioscience?  Dr Brahmachari:  Open Source Drug Discovery (OSDD) has shown tremendous scope for future. The open innovation in a country like India where we have so many young minds, serves as a great platform to express ideas and partner. At present close to 6,000 people across the globe are a part of the project and we are moving towards a new direction. Already clinical trials have been initiated on a TB molecule in partnership with TB Alliance. We are starting innovation complexes to catalyze ideas. Eight innovation hubs will be located in Kolkata, Mumbai, Chennai, Delhi, Pune, Hyderabad, Ahmedabad and Bangalore. Delhi will focus on affordable healthcare, Kolkata on biomedical instrumentation, areas of surgical equipment and glass fibre technology. The Micro, Small and Medium Enterprises (MSME) sector being our next focus, the hubs will bring together incubators, entrepreneurs and businesses. Also we are keen on genomic diagnostics. About $210 million has been invested in a project on ayur-genomics. We have also decided to start an institute of synthetic and system biology soon. Apart from that we will have a biostatistics and data quantitfication institute in which one-fourth of the efforts will be on bioscience and healthcare. In the area of education, we now have CSIR Academy, which has been made functional since April 2012. It will offer 500 courses including life sciences to students across India. The best part would be that for doing an MSc in genomics you will no longer require a degree in same subject. A mathematics graduate is free to do masters in biotechnology. That is the USP of the whole program. What is the vision for CSIR on its 100th anniversary?  Dr Brahmachari:  Six years back, I had a strong doubt whether we would be able to stand relevant by 2012. But now I say this with sense of pride that CSIR has continued to achieve significant results through the research efforts. Over a period of time, the changes have been surgical and not just theoretical. The innovation spirit is getting very high and the young people in the organization are feeling empowered. There is no place for autocratic leadership in CSIR and as a forward looking organization; it will continue to lead India towards being self reliant in various areas. I think we will not only live 100 years but enjoy them thoroughly. Rahul Koul ]]> <![CDATA[Biologicals approval on decline]]> https://biospectrumindia.com/news/95/2570/biologicals-approval-on-decline.html https://biospectrumindia.com/news/95/2570/biologicals-approval-on-decline.html Thu, 08 Nov 2012 16:51:00 +0530 India needs a concerted approach to boost research and development in biopharma and strengthen the ecosystem supporting the growth of the segment The biopharma sector, which contributes about 60 percent of the Indian biotechnology industry, has been witnessing a compounded annual growth rate of 21.63 percent in the last 10 years. The sector witnessed a fall in the growth rate in the recent years. This is mainly attributed to drop in number of new products launched and decline in the prices of biologicals due to price war between the Indian manufacturers and multinationals. Till September this year, about 10 companies have launched biotech products and products related to biotechnology. Amongst these five companies, are in bioinformatics space, four are in diagnostics and one is from the biopharma area have announced the launch of their products in 2012. In bioagriculture space, 33 companies got approval from Genetic Engineering Approval Committee (GEAC), the apex body constituted under the Ministry of Environment and Forests for marketing 213 Bt cotton hybrids during May 2012 season. Products launched by Indian biotech companies in 2012 No. Product Sector Company Launch date Price 1 Hepatotoxicity Prediction Platform Bioinformatics Strand Life Sciences March 2012 $12000 per drug to be tested 2 MCPaIRS (Patent Database) Bioinformatics Molecular Connections January 2012 $3000 per license 3 ViTAL (VLife Toxicity Alerts) Bioinformatics VLife Sciences July 2012 Not provided 4 BioAxcell Bioinformatics BioAxis July 2012 License purchase at 20,000 5 ePep Bioinformatics Polyclone Bioservices January 2012 ePep integration charges: $2,000. Annual subscription charges: $2,000 6 act on Temozolomide (MGMT) Diagnostics Acton Biotech January 2012 7500 7 Dengue NS1 and IgG + IgM Test Kit, Diagnostics Bhat Biotech August 2012 160 per test 8 SES platform Diagnostics XCyton Diagnostics January 2012 15,000-18,000 per patient sample 9 Reli Stat Diagnostics Reliance Life Sciences August 2012 7,750 per kit 10 Inactivated JE vaccine Biopharma Biological E September 2012 985.00 for 0.5ml Vial The biopharma sector, specifically the vaccine space, witnessed a launch of fewer products being launched in 2012 as compared to that in previous years. In the last three to four years, the number of product launches has fallen from 10 biologicals in 2009 to eight products in 2010, five in 2011 and to just three as of August 2012, according to the Central Drugs Standard Control Organization (CDSCO). The three companies, which have launched their products in biologicals space during 2012 include Ranbaxy Laboratories, Bharat Biotech International, and Biological E. Ranbaxy Lab, which has acquired Biovel Life Science, a biotechnology company from Bangalore in 2010 has launched Haemophilus Influenzae Type b (Hib) conjugate lyophilized vaccine and Vi capsular polysaccharide Salmonella typhi (Typhoid) vaccine in March for active immunization against Haemophilus Influenzae Type b infection in children of the age group of 6 weeks to 5 years and for active immunization against Typhoid fever for adults and children older than two years of age respectively. In June, Bharat Biotech International got the approval from DCGI for marketing inactivated Japanese Encephalitis vaccine. Even Biological E launched Inactivated JE vaccine in September. Identifying a possible disease or disorder Coming to diagnostics space, the DCGI, till August 2012, has given approval for 76 kits from Indian manufacturers (includes 36 HIV diagnostic kits, 21 HBsAg diagnostic kits used in the detection of hepatitis B virus mutation within â€œaâ€? determinant and 19 diagnostic kit of hepatitis C virus (HCV) for blood bank use. The number of diagnostics kits allowed by DCGI to import and market in India for a similar disease was higher as compared to the local manufaturers (62 kits for HIV, 55 for HBsAg and 46 for hepatitis C virus (HCV). In all, India has about 25 companies involved in manufacturing of diagnostic kits and reagents. During 2012, Bhat Biotech, a diagnosic company from Bangalore has launched Dengue kit. The company noted that the kit is very sensitive and easy to use. This kit can detect both antigen and antibodies. It is fast as it is based on the lateral flow immunochromatography based technology. This test can detect the infection within three days of infection. Besides that, the market witnessed a soft launch of SES platform by XCyton Diagnostics from Bangalore. The company observed that the platform allows for simultaneous identification of 26 different pathogens in a single sample in a single test. It detects RNA viruses, DNA viruses, bacteria, parasites and fungi in a single sample of one ml of cerebrospinal fluid in a single test. Currently existing products are uniplex PCRs and immunodiagnostics. If a battery of these tests have to be performed it will cost nearly 45,000-50,000 per patient per sample and takes 7-10 days for completion. SES on the other hand costs only one third of that for a seven hour process. Reliance Life Sciences, one of leading life sciences companies of India from Mumbai, having wide interest in biotechnology has launched ReliStat in August 2012. ReliStat is a thrombin-based hemostatic kit for use in surgeries to control excessive bleeding and post operative oozing. Currently there are no similar products existing in the Indian market. Priced at 7,750 per kit, this hemostatic kit is expected to be used by surgeons in various surgeries including oncology surgeries, neuro surgeries, general surgeries as well as laparoscopic procedures. Thrombin, supplied as part of the ReliStat kit is manufactured in-house in the state-of-the-art manufacturing facility in Navi, Mumbai. List of biologicals approved for marketing from 2009 till August 2012 S.No. Firm Molecule Approved Date 1 Biomed, Ghaziabad Meningococcal polysaccharide vaccine (Group A &C) Dec 01, 2009 2 Serum Institute of India, Pune Diphtheria, Tetanus, Pertusis, Hepatitis-B and Haemophilus Influenzae Type b Conjugate Vaccine Adsorbed, liquid. Dec 12, 2009 3 Panacea Biotec, New Delhi Oral Poliomyletis Vaccine (Type 1, 2, & 3) Feb 24, 2009 4 Shantha Biotech, Hyderabad Killed Bivalent (O1&O139) oral cholera vaccine Feb 24, 2009 5 Panacea Biotec, New-Delhi Diphtheria ,Tetanus and whole cell pertussis (DTwP) vaccine Mar 19, 2009 7 Biovel Life Science (now part of Ranbaxy Lab), Bangalore Haemophilus Influenza type b (Hib) conjugate vaccine Mar 24, 2009 8 Biovel Life Science (now part of Ranbaxy Lab), Bangalore Vi Capsular Polysaccharide Typhoid vaccine May 24, 2009 9 Biologicals E., Hyderabad Reconstituted pentavalent vaccine(diphtheria, tetanus, Pertussis (whole cell),Hepatitis b (r DNA) and hib conjugate vaccine (adsorbed) Sep 23, 2009 10 Panacea Biotec, New Delhi Bivalent Poilo Ty 1& Type 3 vaccine , Live Oral Nov 19, 2009 11 Hafkine Bio-Pharma, Mumbai Bivalent Poilo Ty 1& Type 3 vaccine , Live Oral Jan 01, 2010 12 Bharat Biotech International, Hyderabad Bivalent Polio Type 1 & Type 3 vaccine , Live Oral Mar 12, 2010 13 Cadila Healthcare, Ahmedabad Influenza Vaccine (Live Attenuated freeze dried) for Intranasal. Jun 18, 2010 14 Serum Institute of India, Pune Influenza Vaccine (Live Attenuated freeze dried) for Intranasal. Jun 18, 2010 15 Panacea Biotec, New Delhi DTwP-vaccine (adsorbed) Sep 21, 2010 16 Biologicals E., Hyderabad Liquid pentavalent vaccine Sep 29, 2010 17 Bharat Biotech International, Hyderabad Pandemic Influenza Vaccine A( H1N1) Virus vaccine (Inactivated) Sep 30, 2010 18 Panacea Biotec, New Delhi Inactivated H1N1 split virion Influenza vaccine (adjuvanted) Nov 08, 2010 19 Panacea Biotec, New Delhi Bivalent Oral Poliomyelitis Vaccine Type 1 and Type 3, Live (Oral) Apr 29, 2011 20 Serum Institute of India, Pune Influenza Vaccine (Whole Virion, Inactivated) (Pandemic H1N1 Vaccine), (Embryonated hen eggs derived and inactivated by betapropiolactone Jun 02, 2011 21 Cadila Healthcare, Ahmedabad Rabies Vaccine, Human IP (Purified Chick embryo cell culture rabies vaccine) PCECVPM Aug 16, 2011 22 Biologicals E., Hyderabad Japanese Encephalitis Inactivated Vaccine Sep 29, 2011 23 Serum Institute of India, Pune Meningococcal A Conjugate vaccine, Lyophilized (Clear glass vial with white Aluminium flip-off seals) Oct 18, 2011 24 Ranbaxy Bangalore Haemophilus Influenzae Type b (Hib) conjugate lyophilized vaccine Mar 14, 2012 25 Ranbaxy Bangalore Vi capsular polysaccharide Salmonella typhi (Typhoid) vaccine Mar 14, 2012 26 Bharat Biotech International, Hyderabad Inactivated Japanese Encephalitis Vaccine Jun 07, 2012 Source: CDSCO Acton Biotech developed a novel oral alkylating agent, Temozolomide, commonly used drug for Glioma and it has been found to be effective only in patients who have an inactive methylguanine methyltransferase (MGMT). This allows doctors to determine if Temozolomide therapy will work on a certain patient and if not then the doctor will recommend something else. Drug approvals India has approved 98 drugs in 2011 for the treatment of many diseases ranging from iron deficiency anaemia to treatment of mild to moderate hypertension and for relief of symptoms of allergic rhinitis to treatment of neuropathic pain. This number has dropped to 22 as of August 2012. However, the number of drugs approved was on rise since 2006 with 161 approvals for marketing in India, to 188 drugs in 2007, 270 drugs in 2008. In 2009, the number of drgus that received the approval were 217. The number increased again in 2010 as the DCGI has given approval for 224 drugs Source: Drug Controllers General of India Currently, there are 20 recombinant therapeutics approved for marketing in India by the GEAC. Since 2005, the Review Committee on Genetic Manipulation (RCGM) under GEAC has approved 94 clinical trials to be conducted in India related to recombinant pharmaceutical and therapeutic products recommended by the DCGI. Though there are several Indian biopharmaceutical companies actively involved in research and development, manufacturing and marketing of biologics, none of these has launched a recombinant therapeutic product during 2012. Software tools and technologies To support development activities in drug discovery and for overcome the failures in selecting the target candidate molecules clinical trials, many companies with back ground in science, technology and mathematics have been developing smart tools. Strand Life Sciences, the first company in India to start its operation in bioinformatics space in 2000 in Bangalore has developed many tools and later added additional features to some of these tools. In 2012, Strand has launched Hepatotoxicity Prediction Platform, a novel systems approach to model pathways in the liver and combined it with in vitro measurements to create a detailed predictive platform. The platform is capable of providing insight into Drug Induced Liver Injury (DILI). This unprecedented approach will help in replacing or reducing animal usage, and increase efficiency of drug development by predicting hepatotoxicity. Similarly, VLife Sciences from Pune has launched ViTAL (VLife Toxicity Alerts) that can predict the genotoxic potential of a compound based on identification and significance of structural alerts. The product will help the companies to assess the genotoxic potential of new products, especially while entering into regulated markets as regulatory authorities and regulations like EMEA, EDQM, USFDA, and REACH provide guidelines on Threshold of Toxicological Concern and safe, acceptable limits of genotoxic impurities associated with the active pharmaceutical ingredient. BioAxis from Hyderabad has come up with a repository of tools, biosoftwares, research protocols and packages which offer wide range of solution in multidisciplinary areas of life science research. It is equipped with routinely used molecular biology, microbiology, immunological needs and other requirements like DNA, RNA and protein sequence annotation and identification to the fully loaded working environments of microarray data analysis and deep sequencing. Bangalore-based Polyclone Bioservices has introduced ePep, a comprehensive web-based tool developed for designing peptides with chemical modifications and analyzing different properties of peptides. ePep calculates 35 different properties of a peptide which are classified into six broad categories and provides graphical overviews of the results in the same webpage.ePep also enables 69 different chemical modifications that can be incorporated with a user friendly interface. While some companies are focussing on developing platform, tools and systems, a few others have focussed on building a proper database. Molecular Connections has started offering MCPaIRS (Molecular Connections Patent Information Retrieval System), the first Indian Patent Full Text Database with Legal status. The data is hand-curated by domain experts and provided in an easy to use web interface for use by patent analysts, attorneys and IP departments of the world. MCPaIRS contains full texts of granted patents and published applications, and may customizable. The bioinformatics tools, diagnostic and biopharma products launched this year, are all set to directly impact the general public since they are focused on India specific issues. An innovative dengue testing kit, an indigenously developed and manufactured Japanese encephalitis vaccine, a diagnostic platform for a wide variety of pathogens are just some of the novel solutions for disorders prevalent in this geography. A large number of these products are developed by small or mid-sized start-ups, indicating that they are slowly becoming the centres of innovative translational research in India. Government grants alongwith scientists having domain-specific expertise have helped a majority of them break the barrier associated with the size of the company. Indian companies have the potential to become truly global players in biologicals and biosimilars mirroring the strong position it has in small molecule generics. For this to come to fruition, India needs a concerted approach to boost both research and development in biopharma and strengthen the wider ecosystem supporting this segment of the industry. Narayan Kulkarni and Manasi Vaidya (with inputs from Vipul Murarka) ]]> <![CDATA[Adoption of new technologies vital for agriculture, says experts]]> https://biospectrumindia.com/news/95/1343/adoption-of-new-technologies-vital-for-agriculture-says-experts.html https://biospectrumindia.com/news/95/1343/adoption-of-new-technologies-vital-for-agriculture-says-experts.html Thu, 08 Nov 2012 12:33:00 +0530 The country needs to adopt new technologies in agriculture and the current mindset over the usage of genetically modified products has to change to ensure that the farmer reaps the benefits out of it and the productivity grows. This was concluded by the experts at an interactive discussion held on October 16, 2012 at New Delhi. 'Technology as a driver of growth: ensuring farm prosperity' was eighth in the series of media workshops and panel discussions on the importance of farm technology organized by IndoAsiancommodites.com, a website devoted to agriculture, technology and metals. â€œLong-drawn regulatory processes are an impediment to spread of technology,â€? said Vibha Ahuja, general manger of Biotech Consortium India â€œOur rules are really old. They were set in 1989 for environmental protection after the Bhopal incident. These rules are for industrial products and can't be applied to agriculture products,â€? she said at a panel discussion on agriculture and technology. Ms Ahuja further said that there was no need for safety concerns over the usage of genetically modified products as there are strict processes in place to test them and approved products like Bt Cotton and Bt Brinjal are safe. â€œWe do the same tests as are done in the United States,â€? she stated and added, â€œRegulators need to communicate better and our scientists don't communicate enough. The civil society may be against GM crops, but that is not the only stake holder. Think of the farmers who are waiting for new technologies.â€? Dr KC Bansal, director, National Bureau of Plant Genetic Resources said, â€œThe bureau has been working to identify genetic resources for rainfed agriculture. That's where we get 40 percent of our crops and that's where 50 percent of agriculture labour is committed. Erratic monsoon due to climatic changes has made things difficult for rainfed agriculture and in such a situation better and high yielding seeds were necessary.â€? Participating in the discussion, the panelists said that it was paramount that biotechnology is harnessed to boost production and any misconceptions over use of bio seeds and food safety issues have to be set at rest. Such technology has to be brought to the doorstep of the farmer to usher in a second green revolution and lift the living standards of farm workers. Rahul Koul ]]> <![CDATA[We are aiming at 15-20 percent growth over the next year]]> https://biospectrumindia.com/news/95/1407/we-are-aiming-at-15-20-percent-growth-over-the-next-year.html https://biospectrumindia.com/news/95/1407/we-are-aiming-at-15-20-percent-growth-over-the-next-year.html Wed, 07 Nov 2012 20:33:00 +0530 Mr Senya Imamichimanaging director, Shimadzu Analytical India With a view of expanding its customer base, Shimadzu Analytical India has been taking concrete steps towards connecting with its customers through various initiatives. Recently, it organized â€œFood Safetyâ€? seminars in five different cities-namely, Bangalore, Hyderabad, Kochi, Mumbai, and New Delhi-to educate researchers about its existing technologies in the food safety space. In a conversation with BioSpectrum, Mr Imamichi, MD, Shimadzu Analytical India speaks about his plans to focus on the food safety vertical and also about the growth of the life sciences industry. Q What do you think that differentiates Shimadzu from its competitors? Mr Imamichi: In our perspective, Shimadzu is a complete solutions provider. Take the example of food; there are various contaminants present in the food that require different types of analysis. Shimadzu is uniquely placed in this regard, as it caters to identifying and analyzing all types of impurities. We have specific packages designed for low-level quantification of all types of inorganic impurities as well as matrix-assisted laser desorption/ionization (MALDI)-based solution for biological contaminants. Hence, Shimadzu is a good option for labs looking to tackle all of these issues. Shimadzu India also has the capability of supplying application packages along with the necessary equipment, allowing the user to adopt according to their needs. Also, they are ably supported by our application scientists. All these steps come under our food safety total solutions initiatives. Such measures offer more value for the customer, as compared to just getting equipment from any vendor. We observe that, the challenge today is to provide the right support team for running the systems. We, at Shimadzu, also conduct over 100 training courses every year, to train the technicians who use the instruments, which shows our commitment to further encourage growth in this field. There are also plans for the expansion of this support centre as well. Q What have been the recent launches in the life sciences segment? We have expanded our mass spectrometry (MS) portfolio recently with the addition of LCMS-8040, LCMS -8080 and a triple quadrapole GCMS TQ8030, as well as Shimadzu's own chromatography data management system. To be frank, in the triple quad MS segment, was a late entrant into the Indian market. However, the market is expanding, especially in India where the rate of expansion is much faster than in other countries. So, even though we have entered a bit late, we see the acceptance for the ultra fast mass spectrometry (UFMS) technology among customers. Q What do you think is the strength of Shimadzu? Shimadzu is very strong in LCMS, GCMS, single quad GCMS, chromatography, single quad LCMS, and spectrophotometers. We have the largest market share in chromatography and spectrophotometers, but we would like to expand it further. We have a market share of 35 percent in chromatography segment, with Shimadzu crossing 14,000 high performance liquid chromatography (HPLC) system installations to date in India. The single Quad MS market has very few players, so our share would be around 35-40 percent. Q Shimadzu has had a very strong and unique relationship with its distributors. Can you elaborate about it? In the analytical landscape, the Shimadzu family consists of Shimadzu India, plus our marketing partners Spinco, Saksham, Swan, and Toshvin. This makes it one of the largest combined forces for Shimadzu products in India. We have adopted this model of partnering with our distributors, so as to leverage their market reach and experience. Q What are the trends you see in the market and what are your future plans for growth? The trend we have analyzed so far is that, people are now looking for more high-end instruments such as MS as compared to the chromatography systems before. The depreciating rupee has affected our operations, however as the generics and biosimilars industry grows, we anticipate a corresponding increase in the need for sophisticated instruments thereby fueling further growth. Most of the developed countries have already established their use of this technology. So its emerging markets such as India that hold a lot of promise and have a lot of demand as well. We are aiming at 15-20 percent growth in the coming years, building on our expanded MS portfolio as well as our other initiatives. Additionally, we are in the midst of planning mini seminars on different issues and other activities to penetrate more deeply into our target base. Manasi Vaidya ]]> <![CDATA[More biotech tie-ups]]> https://biospectrumindia.com/news/95/2804/more-biotech-tie-ups.html https://biospectrumindia.com/news/95/2804/more-biotech-tie-ups.html Wed, 07 Nov 2012 20:16:00 +0530 Ch. Srinivas Rao The author is Editor of BioSpectrum srinivasch@cybermedia.co.in On October 5, 2012, The Association of Biotechnology Led Enterprises (ABLE) and the US-based Washington Biotechnology and Biomedical Association (WBBA) signed a Memorandum of Understanding (MoU) toward deep and wide-ranging cooperation in the field of biotechnology. This agreement will provide ABLE and WBBA members the opportunities to co-operate and invest in the State of Washington and in India. Elaborating further on the MoU, Dr PM Murali, president, ABLE, said, â€œThe collaboration aims to achieve breakthrough discoveries and provide affordable solutions in biomedicine, agriculture, and energy.â€? â€œWe see India as the growth engine of tomorrow and one of the fastest growing economies in the world. The collaboration with ABLE is significant to facilitate best of research in biotechnology from both the countries,â€? said Chris Rivera, president, WBBA. He listed out personalized medicine, bioinformatics, and agribiotech as the potential areas of cooperation. Rivera highlighted the fact that Washington state has emerged as a great opportunity area for the biotechnology industry. â€œBetween the year 2001 to 2010, the jobs in the state grew 15.8 percent while the national job growth in US remained at average six percent,â€? he added. In a separate development, underlining its commitment to India, Fraunhofer inaugurated its representative office in Bangalore in October. Fraunhofer works with 30 of the 50 leading companies in India and, last year, Indian companies outsourced 1.3 million euros worth of research projects to various Fraunhofer institutes. Fraunhofer-Gesellschaft is one of the leading organizations for applied research in Europe and its research activities are conducted by 60 Fraunhofer Institutes at over 40 different locations throughout Germany. Prof. Hans Jorg Bullinger, Immediate Past President Fraunhofer-Gesellschaft, reiterated Fraunhofer-Gesellschaft's commitment to working with Indian partners in pursuing long-term sustainability strategies that are unique to the Indian situation. The passing month also saw yet another industry delegation visit India. An Israeli delegation visited Ahmedabad, Bangalore, Delhi, and Mumbai and held round-table conferences. Collaborations, certainly, are a very important tenet for growth and development of biotech. More so in the context that today's research assumes global proposition and alliances are an integral part of the success script. India is now an important component of the global scheme of biotech initiatives and several leading biotech nations like the UK, the US, Israel, Japan, Australia, Canada, Sweden, Spain, Finland, Denmark, and Germany today are actively engaging and connecting with the Indian researchers and the vice versa. The step up for this activism is due to the proactive efforts of DBT, ABLE, FICCI, and CII (Indian side) and their counterparts from outside. It's a welcome move. We need more such initiatives and have to go beyond the realms of the soft agreements to produce concrete results that are beneficial to the society. ]]> <![CDATA[â€œWe are aiming for 25 percent of our revenues from APACâ€?]]> https://biospectrumindia.com/news/95/5666/we-are-aiming-for-25-percent-of-our-revenues-from-apac.html https://biospectrumindia.com/news/95/5666/we-are-aiming-for-25-percent-of-our-revenues-from-apac.html Wed, 07 Nov 2012 20:11:00 +0530 Mr Marc N Casperpresident and CEO, Thermo Fisher Scientific, USA Thermo Fisher Scientific, a global player in serving science has revenues of about $12 billion, with approximately 39,000 employees serving customers within pharmaceutical and biotech companies, hospitals and clinical diagnostic labs, universities, research institutions and government agencies, as well as environmental and process control industries. With a revenue of $1.8 billion coming from emerging markets and Asia Pacific region-growing at the rate of 20 percent-the company has various strategies in place for the region, such as scaling up its commercial teams to drive growth, optimizing supply chain, service and commercial operations to differentiate the customer experience, continuing to invest in localized technology development and expanding low-cost region manufacturing footprint to take it to new heights. In an exclusive interview with BioSpectrum, Mr Marc N Casper, president and chief executive officer of Thermo Fisher Scientific, shares the company's strategies on investments related to research and development, acquisitions, growth for the emerging markets, pricing and regulatory issues. Q Thermo fisher has increased its investments on acquisitions and purchasing property from $837 million in 2009 to $6 billion in 2011. How much have you set aside towards investments in 2012 for similar activities?  Mr Casper:  Actually, since 2009 we have generated about $10 billion in capital from our free cash flow and deployed about $7 billion for acquisitions. While we cannot disclose what acquisitions we may be making in the future, Thermo Fisher has a proven track record of achieving our operating income objectives through revenue and cost synergies and tax efficiencies. Q Will your focus now be more on acquisitions?  Mr Casper:  Thermo Fisher looks at organic as well as inorganic routes to grow. We have been investing in acquisitions that help us to enhance our offering to our customers and increase our access to growing markets worldwide. Since 2009, we have deployed about $7 billion in acquisitions, including the larger Dionex, Phadia and One Lambda deals. Acquisitions and integrations are among our core competencies, regardless of the economic environment. Just to cite an example, we have successfully managed the Dionex integration, delivering operating income from revenue synergies, cost synergies and tax efficiencies. Some of the other acquisitions that we have successfully completed in the recent past are Ahura Scientific, BRAHMS, Doe and Ingalls, Fermentas, Finnzymes, and TREK Diagnostics. Each of these acquisition has brought on board some great talent and transformed our competitive position. Q Your company is generating about 15 percent of its revenue from emerging markets. What factors in emerging markets are favoring your business opportunities? Which countries in the emerging markets do you bet upon for a high growth rate?  Mr Casper:  An important part of our growth strategy is to increase our presence in Asia Pacific and emerging markets. At the time of our merger in 2006, that created Thermo Fisher Scientific, only 10 percent of our revenue came from Asia Pacific and emerging markets. Today it is 20 percent and in five years we expect it to be at least 25 percent. Our tremendous success in China, India and other parts of these exciting markets has shown that we have a proven strategy. Q What will your strategies be to improve this growth to 25 percent in the coming years?  Mr Casper:  There are various initiatives that we are adopting to propel our growth in APAC and emerging markets in the coming years. We continue to scale up our commercial presence in these regions-as of now, we have about 5,600 people in APAC and emerging markets, with almost 960 in India alone. You could say that we have the largest footprint in emerging markets within our industry. We have already doubled our business in the past five years from these emerging markets, and our goal is to reach revenues of about $3 billion by 2016. Last year, we established an APAC Chromatography Center of Excellence in Ahmedabad to support the customers in India and APAC on method development and also to provide faster solutions for their complex research and development (R&D) and quality control problems. Our demo center in Mumbai and training center at Nasik are also accessed by our customers to help them chose the right technology. Our state-of-the-art clinical trial services facility at Ahmedabad offers world-class services for our Indian and international customers, including comparator sourcing, storage, packaging, labeling and global logistics. We have also expanded our chemicals business, (acquired from Qualigens) by investing in toll-conversion facilities, quality procedures and a new centralized warehouse. Over the past two years, we have grown in China at a CAGR of over 20 percent. We understand the growing business opportunities for our environmental instruments business in this region and we moved the headquarters of this business to China several years ago. With the changing population demographics in the region, healthcare and diagnostics also offer some exciting opportunities. We would like to replicate our successes in India and China, and also in some new emerging markets such as Korea, Brazil and Russia. Q China and India each recorded a growth of 20 percent in 2011. What will be your investments to support the growth of market in these two countries?  Mr Casper:  Apart from what I have just mentioned, we are investing in establishing partnerships with our key customers in India and offer them complete work flow solutions through our entire width and depth of technology and services. As more and more of our global customers invest in India, they will require the same standardized technology that they are using in other locations. Pharmaceuticals, biotechnology and healthcare are exciting markets for us here in India. We are currently setting up a new manufacturing facility for our lab products at Suzhou, China that will enable us to respond to APAC-based customers faster and more efficiently. We have also invested in other manufacturing operations, demo centers and a technology center at Shanghai. Today, 20 percent of our revenues in China come from products that we are manufacturing in China. Q What new offerings, packages or additional services do you offer to the customers especially in academia and government agencies, for which the company has been witnessing fall in the revenue growth in last couple of years?  Mr Casper:  Looking at the end markets, we are indeed very balanced as nearly a quarter of our revenues come from each of our major market segments- pharmaceuticals and biotechnology, healthcare and diagnostics, and academic and government. This, combined with our unique product mix spanning instruments, equipment, consumables, reagents and chemicals, software and services gives us an industry-leading position in most markets that we serve. Q We have noted that your focus will be on increasing R&D budget to develop new products, adapt to rapid and significant technological change and respond to introductions of new products by competitors to remain competitive. What are your strategies to address the competition arising from the launch of new products by competitors?  Mr Casper:  Thank you for your observations and yes, you are absolutely correct. Last year, we invested about $350 million in R&D, which is between 4-5 percent of our manufacturing revenue and we are proud that our 1,700 scientists are busy creating new and better technology for our customers. We have a strong intellectual property position and a world-class advisory board with members from leading institutions such as Harvard Medical School and Stanford School of Medicine.Our focus on innovation enables us to develop better, more efficient technologies keeping in mind the changing requirements of our customers. Q Of the three Thermo brands namely - Thermo Scientific, Fisher Scientific and Unity Lab Services, where do you see the growth potential in Asia Pacific region and why?  Mr Casper:  Our organization has evolved over the past decade through a variety of factors including a number of interesting brands and technologies that are now offered through one entity. It is very important for us to position our brands and communicate our combined technology platforms in a simplified manner to our customers and therefore we describe each of our brands as having specific attributes that address customer needs. The Thermo Scientific brand represents the scale and depth of our capability in analytical instruments, laboratory products, biosciences products and specialty diagnostics. The Fisher Scientific brand represents choice and convenience and a variety of purchasing options as well as our clinical trial services, logistics and an eCommerce platform. Unity Lab Services is our newest brand, launched earlier this year. Unity Lab Services offers product and laboratory support services to create a single solution for customers to optimize productivity and reduce their total cost of laboratory operations. Q How is Thermo addressing sensitive issues such as pricing and regulatory formats while handling the customers in Asia Pacific?  Mr Casper:  I think we are very competitive in our pricing when compared to our major competitors. We constantly work on upgrading our technology to meet the changing demands such as precision and reproducibility (driven by regulatory) or quality control productivity (driven by manufacturing). Looking ahead, in countries such as China, we would like to see around 50 percent of our revenues coming from products made within China. In India, we have initiated local assembly of our liquid handling instruments. Q How different is your recently launched Unity Lab Services from other similar services offered by the competitors?  Mr Casper:  Unity Lab Services represents a range of capabilities, from traditional laboratory instruments and equipment services to enterprise-level support, including business analytics for continuous improvement, and management of laboratory staffing and consumables inventory. These services can be implemented across a broad range of laboratory environments and can be scaled from service on a single instrument to a highly customized, comprehensive service program at the laboratory, site or enterprise level. Narayanan Suresh, Narayan Kulkarni and Vipul Murarka ]]> <![CDATA[Drug Discovery Collaborations The Way to go..]]> https://biospectrumindia.com/news/95/1245/drug-discovery-collaborations-the-way-to-go-.html https://biospectrumindia.com/news/95/1245/drug-discovery-collaborations-the-way-to-go-.html Wed, 07 Nov 2012 19:52:00 +0530 The latest Advinus-Takeda collaboration along with a spate of other recent out-licensing deals in the pharma industry have indicated a trend of multinational pharma companies looking to not just outsource their chemistry services, but rather allow Indian entities to head the part of their drug discovery programs too. BioSpectrum looks at where India's potential lies as a drug discovery destination Over the last few decades, India has reiterated its capabilities in providing dependable and cost-effective chemistry services to big pharma through a multitude of outsourcing deals. A large percentage of these collaborations, however, are no longer limited to short-term outsourcing agreements but rather long-term milestone-based partnerships. Takeda Pharmaceutical, the Japanese pharma giant, two years after announcing its intention to strengthen its India focus, including those for a variety of functions such as sales and marketing, research and development, chemistry, manufacturing and control (CMC), manufacturing and IT, took the plunge, with a three-year drug discovery collaboration with Advinus Therapeutics in October this year. As a part of the deal, Advinus Therapeutics will receive a guaranteed payment of $36 million as well as a milestone based payment of $9 million, dependent on the targets achieved during investigational new drug (IND) candidates selection. â€œThe Takeda-Advinus deal seems to be a holistic one, which will help other internal programs and provide them good breathing space as well as provide an impetus to drug discovery in India,â€? said Mr Siddharth Dhodi, manager, life sciences, Yes Bank. â€œThis deal will not be based on prior research carried out at Advinus,â€? Dr Rashmi Barbhaiya, CEO, Advinus Therapeutics,â€? said by adding, â€œInstead we will involve entirely new projects in therapeutic areas such as inflammation, CNS, and metabolic diseases, on which Advinus has developed expertise through its past projects.â€? Highlighting the sentiment, Dr Ajay Kumar Sharma, associate director, pharma and biotech, healthcare practice, Frost & Sullivan, South Asia & Middle East said, â€œAdvinus has been focusing on developing its own drug candidates for quite some time and now with the support of Takeda coming in it would be no surprise if the world sees some blockbuster drugs coming out of their arsenal in the next decade. This move will also increase the confidence for other big pharma's to re-think their strategies.â€? Under this collaboration, while Takeda would retain its commercialization rights for any drug candidate emerging out of this partnership, Advinus would be eligible for royalties on its worldwide product sales. This ofcourse is not the first of such deals. Most Big pharma have struck a deal with Indian contract research organizations (CROs) or pharma companies for drug discovery collaborations in the last decade or less. Pfizer had entered into a R&D collaboration with TCG Lifesciences in 2009. In February this year, TCG Lifesciences delivered a pre-clinical candidate to Pfizer in return for a milestone payment as per the agreement. TCG Lifesciences also has a similar ongoing drug discovery based partnership with Endo Pharmaceuticals, under which it has achieved significant breakthroughs. Commenting on these developments, Mr Siddharth Dhodi said, â€œThe trend of companies moving from a fee-for-service-model to long term partnerships involving research and development of drugs has been growing for some time now. The model which allows for milestone based payments with big pharma owning the assets, is a win-win situation for both.â€? Worldwide the trend to outsource research projects to counter the mounting costs seem to have become the norm. As Dr Paul Chapman, general manager, pharmaceutical research division, Takeda said, â€œCollaboration with Advinus is one of our initiatives to enhance our research productivity.â€? Such collaborations not only mitigate the huge financial risks associated with drug discovery, due to the lower costs for conducting research in India, they also allow to speed up the process considerably. Another model that is being closely looked at is the one involving out-licensing of Phase I molecules to companies that can conduct further clinical trials for the same. Most experts echo the fact that the Indian pharmaceutical industry still lacks any player that has the resources to take a drug the whole nine yards from discovery to clinical trials. In such a scenario, drug discovery partnerships can help put India on the world map. Glenmark has been following this strategy to keep its innovation quotient up, and at the same time fund the company's research expenses. Two drugs developed by Glenmark for chronic pain and ulcerative colitis were out-licensed to Sanofi in mid 2011. They are currently in Phase II trials. One of them, a biologic, is a first-in-class therapeutic monoclonal antibody for chronic autoimmune disorders. Sanofi has licensed the rights to all therapeutic indications and is conducting the clinical development program including this trial. â€œThis model allows innovative research to be rewarded and presents a niche opportunity to Indian companies, as big pharma is looking for cheaper solutions,â€? adds Dr Neelima Joshi-Khairatkar, senior vice president, Glenmark Pharmaceuticals. The road to develop an Indian origin New Chemical Entity (NCE) with a foreign collaborator has however, hitherto been lined by a number of disappointments. None of the molecules developed as a part of licensing deals conducted over the past years, have been successful in clinical trials, yet. Drug discovery programs involving Glenmark, Dr Reddy's Labs, Merck, Eli Lilly and other players have not yielded positive results. Other deals such as Merck-Ranbaxy, Jubilant-Eli Lilly were called off a few years after they were started. Despite these setbacks, India's capabilities of providing a low-cost alternative for drug discovery continue to be explored. The drug discovery expertise being sought is also evolving. Dr Sharma opined that, â€œThe Takeda-Advinus deal is a good start as largely Indian CRO's were considered for their costs for chemistry process involving drug manufacturing. The pre-discovery or the biology processing was mostly absent in outsourcing deals.â€? It remains to be seen if the recent positive decisions such as allowing foreign direct investment (FDI) in pharma would send out the right message to big pharma about investing in India's potential, both in terms of cash inflow and creating intellectual property. Inspite of the challenges, the future is beckoning, as Dr Rashmi expresses, â€œDrug discovery is in its infancy in India and we have a long way to go; especially in the area of early drug discovery. However, we have made a good beginning and there is a promising future.â€? Manasi Vaidya ]]> <![CDATA[Front-runner in nanoscience]]> https://biospectrumindia.com/news/95/2050/front-runner-in-nanoscience.html https://biospectrumindia.com/news/95/2050/front-runner-in-nanoscience.html Wed, 07 Nov 2012 19:47:00 +0530 Nanobiotechnology Dr Murali Sastry director, DSM India Innovation Centre, Gurgaon â€œAs scientists we obviously would like to publish papers, but the benefits must be enjoyed by the society. Translational research is such that it always gives you pleasure,â€? says Dr Murali Sastry, who developed Swach, a low-cost water purifier with enormous societal impact. A well known nanobiotechnologist, Dr Sastry has close to 25 years of research experience in the field of materials chemistry. An interdisciplinary scientist, Dr Sastry was instrumental in creating a Centre for Nanotechnology, funded by the Department of Science and Technology (DST) at National Chemical Laboratory (NCL), Pune. In 2005, he moved to TATA Chemicals as chief innovation officer and set up the innovation center that delivered the low-cost water purifier, Swach. In Nov 2011, he moved to DSM India, where he is the director of India Innovation Centre that will incubate new businesses for DSM in areas on national relevance. Dr Sastry's higher education started in 1982 with Masters in physics and continued with a doctorate in thin film technology from the Indian Institute of Technology, Chennai in 1987. Thereafter, he went on to work as a postdoctoral fellow between 1988-91 at the International Centre for Theoretical Physics at Trieste, Italy. He worked as a visiting faculty at the University of Maryland at College Park, USA in the year 1998-99 and at CNRS in Orsay, France from 2001-03. He continued as a federation fellow at the Royal Melbourne Institute of Technology, Melbourne and as professor in Department of Atomic Energy at Central University, Hyderabad in the year 2006. Dr Sastry has authored over 360 international publications, 10 chapters in books besides holding 20 Indian and US patents. He has a number of national and international awards to his credit including the Shanti Swarup Bhatnagar Prize in Chemistry in 2003 for incisive work on nanomaterials. More recently, he was awarded the Thomson Reuters Research Excellence â€“ India Citation Awards 2012 in the area of nanobiotechnology. Besides being the editor for the Materials Research Bulletin (Elsevier), Dr Sastry serves on the international advisory boards of seven leading chemistry journals. He is also the associate editor (Asia) of Applied Nanoscience. He has earlier served on advisory boards for the Department of Biotechnology (DBT), DST, Presidential Nanotechnology Committee, and Council of Scientific and Industrial Research (CSIR), Government of India. Currently at DSM, Dr Sastry is looking for suitable ideas and opportunities in the nanobiotechnology. His research interests include interfacing biologicals with inorganic nanomaterials, understanding biological process in their nanodimensions, developing new industrially relevant renewable materials and green processes, as well as addressng the ethical issues in application of nanomaterials. Though excited about the government initiatives, Dr Sastry feels that there is still lot more to be done. â€œGovernment agencies are doing their bid. DST has many programs in nanotechnology and many incubators too have been put up. Good quality research is being carried out at the Indian institutes, but it will still take time to establish a firm connection. What requires to be done now is the industry involvement in the product development. The interface between the industry and the public institutes has to be much better,â€? opined Dr Sastry. Rahul Koul ]]> <![CDATA[Bangalore India Bio 2013 in February]]> https://biospectrumindia.com/news/95/1232/bangalore-india-bio-2013-in-february.html https://biospectrumindia.com/news/95/1232/bangalore-india-bio-2013-in-february.html Mon, 08 Oct 2012 15:02:00 +0530 (L-R): ISN Prasad, principal secretary to Government, Dept of Information Technology, Biotechnology and Science & Technology, Govt of Karnataka, Dr Kiran Mazumdar Shaw, chairperson, Karnataka's Vision Group on Biotechnology and CMD, Biocon, Subir Hari Singh, additional chief secretary, Govt of Karnataka, Prof. Sharat Chandra, professor Emeritus, Dept of Microbiology & Cell Biology, IISc and Prof. G Padmanban, NASI-chair professor, IISC at the curtain raiser of Bangalore INDIA BIO 2013 on September 25, 2012 in Bangalore The Department of Information Technology, Biotechnology and Science and Technology, Government of Karnataka, Vision Group on Biotechnology and MM Activ Sci-Tech Communications jointly announced that, Bangalore India Bio (BIB) 2013 will be held from February 4-6, 2013 at the Lalit Ashok Hotel, Bangalore. The announcement was made by ISN Prasad, principal secretary to Government, Department of Information Technology, Biotechnology and Science and Technology, in the presence of Dr Kiran Mazumdar Shaw, chairperson, Karnataka's Vision Group on Biotechnology and CMD, Biocon and Subir Hari Singh, additional chief secretary, Government of Karnataka. Emphasizing the point that Karnataka is working closely with the biotechnology sector, ISN Prasad mentioned that, â€œThere will be new highlights at the 13th edition of the BIB. We hope that the incubation center for biotechnology will be completed by March. We are also building a large biotech park in Electronics City, Bangalore with the help of Alexandria Park, which we hope will be operational in the next two years.â€? When BioSpectrum highlighted the fact that, enrollment in the biotechnology-related courses has declined this year, Dr Kiran Mazumdar Shaw responded by saying that, â€œEarlier, the curriculum that was taught in the institutions did not meet the industry expectations and hence there has been a vicious cycle of industry not recruiting the graduates and also the students not applying to biotechnology-related courses. We have broken this cycle through the BT finishing schools scheme, where we have done the course correction and the courses are now tailor-made according to what industry requires.â€? It is expected that more than 700 delegates, 100 renowned speakers from India and abroad and more than 100 exhibitors will participate. Many MoUs, technical tie-ups and business collaborations are expected to be signed during the three-day Bangalore India Bio 2013 event. Narayanan Suresh and Vipul Murarka Frost & Sullivan Healthcare Awards 2012 It was a double delight for Bharat Serums and Vaccines (BSV) top brass at the Frost and Sullivan Healthcare Excellence Awards 2012, which was held in Mumbai on September 21, 2012. Not only did it manage to bag the coveted fastest growing Indian biotechnology company of the year award, but SIRO Clinpharm, one of India's first CROs started by the BSV management, won the â€œIndian Clinical Research Organization of the Yearâ€?. Bharat Serums and Vaccines invests over 12-14 percent of its revenues into R&D and showed a 30 percent growth in 2011-12. On receiving the award, Bharat Daftary, CMD, Bharat Serums and Vaccines said that, â€œOur company was founded to address the lack of biologicals. Over the years , we have strived to address that issue. We were the first company in India to launch a biosimilar recombinant FSH three years ago. Moving ahead too, we will strengthen our R&D capabilities and focus on unmet needs.â€? Other winners in the biotech and pharma space included Roche Diagnostics India, bagging the in-vitro diagnostics company of the year, fastest-growing indian international pharmaceutical company of the year being given to Sun Pharmaceuticals, diabetologist's award for the best diabetology company of the year went to Novo Nordisk India. The paediatrician's award for the best vaccine company of the year was awarded to GlaxoSmithKline Pharmaceuticals. Abbott India was adjudged the MNC pharmaceutical company of the year and Roche India the best oncology company of the year. Frost & Sullivan also honored Dr Habil Khorakiwala, chairman, Wockhardt Limited, with a special Lifetime Achievement Award. The 4th Annual India Healthcare Excellence Awards 2012, recognized those companies which displayed innovative growth strategies and solutions in the healthcare industry for 2011-12. The award selection procedure was lauded by the august gathering as impartial and thorough. Frost & Sullivan's analyst team shortlists companies for each award category on the basis of detailed research on pre-defined parameters, followed by interviews with the shortlisted companies to verify facts. Thompson Reuters honors scientists India's continuing influence on global scientific research was recognized by the intellectual property and science business of Thomson Reuters. Ten of India's leading researchers were honored during the â€œThomson Reuters Research Excellence â€“ India Citation Awards 2012â€? presentation event held on September 12, 2012 at New Delhi. The ten award recipients were selected based on citation impact analysis conducted by Thomson Reuters, considered as world's leading source of intelligent information for businesses and professionals. Among the 10 recipients, Dr Murali Sashtri received the award in nanobiotechnology category, while others received awards in different areas of science. Dr Thirumalachari Ramasami, secretary to the Government of India, Department of Science and Technology, who gave away the awards, while appreciating the works done, also pointed out that the purpose is to look at the trends that can give the indications on innovation. â€œSuch occasions help us to catch the trends that could be decisive in furthering the cause of science.â€? Pharma companies gear up to follow â€œQuality by Designâ€? At the recently held, DIA IT Life Sciences Summit 2012, a host of current topics were discussed at length among senior members of the pharma, CRO and IT communities. Topics such as, Is Pharma exploiting IT enough, Methods to bridge the drug discovery and development chain through IT, Enabling integrated clinical enterprise pharma compliance, Social media and more allowed the audience to actively engage in thought provoking discussions. This was the very first DIA India conference on Information Technology in Life Sciences. One of the discussions also focused on the need for quality by design in drug discovery and development. The USFDA had made an announcement asking for generic drug manufacturers to implement Quality by Design (QbD) into their Abbreviated New Drug Applications (ANDA) by 2013. Through the two days of this conference, the attendees heard about latest developments, case studies and solutions from Life Science industry experts. Sessions featured expert presentations on the latest trends and technology advances that are reshaping the life sciences industry. The next IT Life Sciences Summit will be held in July 2013 in Bangalore.  This Month 5th Bangalore Nano December 5-7, 2012 Bangalore www.bangalorenano.in Bangalore Nano is organised by Department of Science and Technology, Government of Karnataka, under the guidance of Vision Group on Nanotechnology and Jawaharlal Nehru Centre for Advanced Scientific Research. The event offers powerpacked knowledge transfer and networking opportunuties. Global Healthacare Summit January 1-3, 2013 Kochi www.aapighsindia.org The 2013 Indo-US global healthcare summit will focus on sharing best practices, developing efficient and cost effective solutions for India in areas such as cardiology, diabetes, oncology, mental health, and immunology. Bangalore India BIO February 4-6, 2013 Bangalore www.bangaloreindiabio.in Since 2001, Bangalore INDIA BIO has been instrumental in promoting the inherent strengths of the Indian Biotech Industry to the outside world and is now acknowledged as the biggest and India's national event on life sciences. 8th Nutra India Summit March 13-16, 2013 Mumbai www.nutraindiasummit.in India's biggest nutraceuticals show offers a fertile environment to share, connect, interact and partner with sector leaders and policy makers to influence the global business trends. The theme is â€œhealth and wellness through nutraceuticals, nutritionals and naturals.â€? ]]> <![CDATA[PE Investments in Biosciences]]> https://biospectrumindia.com/news/95/1115/pe-investments-in-biosciences.html https://biospectrumindia.com/news/95/1115/pe-investments-in-biosciences.html Mon, 08 Oct 2012 14:54:00 +0530 IndoUS Venture Partners invests in Vyome Biosciences IndoUS Venture Partners (IUVP), a venture capital firm which provides early and mid- stage funding to new or growing businesses in India, has invested $3.5 million (18.5 crore) along with Aarin Capital and Navam Capital as coinvestors in Vyome Biosciences, an innovation-driven dermatology company focused on developing novel and innovative treatments for common skin conditions such as dandruff, acne, pigmentation disorders and wound healing. Dr Kumar Shiralagi, managing director, IUVP, said, â€œWe are backing a top notch scientific team assembled in India that is leveraging leading edge platform technology to develop promising products to address the $20 billion global dermatology market.â€? Vyome, a privately-held biopharmaceutical company founded in August 2010 and based in Delhi, had raised seed funding from Navam Capital. Vyome has assembled a world-class management and scientific team that collectively have a significant track record of conducting acclaimed scientific research, developing breakthrough products and building sustainable businesses. Vyome will deploy the new financing to advance the clinical development of its lead antidandruff products, and to accelerate the pre-clinical development of its anti-acne products. ChrysCapital invests in Intas Pharmaceutical and Eris Lifesciences ChrysCapital that manages $2.5 billion across six funds and aspires to be the leading investment firm in India has invested in two life sciences companies in India. While Eris Lifesciences is an Ahmedabad based pharmaceutical player with very strong focus on chronic therapy , IntasPharma is a formulations company with a diversified product portfolio focused on chronic segments such as gastro, cardiovascular and psychiatry. Sanjiv Kaul, managing director, ChrysCapital Advisors said, â€œThe promoter of Eris Lifesciences, Amit Bakshi, is a pharma veteran who has very inspiring. The company is light on manufacturing assets but very heavy on brand creation and promotion. ChrysCapital invested $43 million for a significant minority stake.â€? Intas Pharmaceuticals, Kaul said is one of the Top 10 pharmaceutical players in India growing at a CAGR of 30 percent over the last seven years since ChrysCapital made its first investment in late 2005. Fidelity Growth Partners India invests in Laurus Labs and XCyton Fidelity Growth Partners India (FGPI), the India-focused private equity arm of Fidelity Worldwide Investment, has invested in two bioscience firms in India recently. Laurus Labs is a company that develops and manufactures active pharmaceutical ingredients (APIs) and XCyton is a diagnostics product company, which developed a syndrome evaluation system (SES) that allows for the identification of multiple organisms like bacteria, viruses, fungi and parasites through a single test. Hyderabad based Laurus, with a focus on anti-retroviral (HIV-AIDS), oncology and nutraceutical products, received $40 million (200 crore). Raj Dugar, senior managing director at FIL Capital Advisors (India), the private equity advisory arm for FGPI, said, â€œWe are very excited to partner with Dr Satyanarayana and his superb management team. In a short span of time, Laurus has established global leadership positions in its key product offerings and continues to drive innovation in its strong product pipeline of difficult-to-make molecules, which we believe will help it build a long-term defensible business.â€? XCyton Diagnostics received $4.5 million (20 crore) from FGPI. â€œXCyton's SES technology platform has the potential to be truly disruptive to the current standard of care. We believe that the company's test service offerings can drive a paradigm shift in the diagnosis and treatment of critical care infections, not only in India but also overseas. We are excited to partner with Dr Ravi Kumar and his team in building one of the few innovation-driven life sciences companies in the country,â€? added Dugar. IIF invests in Shantani Proteome India Innovation Fund (IIF), formerly known as NASSCOM-ICICI Knowledge Park Innovation Fund, is a $25.3 million venture capital fund managed by IKP Investment Management. It invests between $0.12 million and $1.2 million in its portfolio companies from different sectors including bio sciences. During this year, it has invested an undisclosed amount in Pune-based Shantani Proteome Analytics, along with Blume Ventures. Besides it has invested in Consure Medical, a firm incubated at AIIMS Delhi and has a medical device that addresses Fecal incontinence. In all it has invested in three life sciences portfolios (the third one-Mitra Biotech) in the last two years. Sharing his thoughts on investing in Shantani, Ashwin Raguraman, vice president, India Innovation Funds said, â€œShantani is a drug discovery technology company, offering a proprietary chemical proteomics technology platform for the identification of the targets of drugs and drug like bioactive molecules. This target information is essential for the understanding of action mechanisms of compounds identified through phenotypic screening. It is also valuable for drug repositioning purposes and for identifying off-target interactions of a drug to understand its toxicity profile. Shantani was incubated at National Chemical Laboratories' Venture Center, Pune and is founded by a scientist Dr Chaitanya Saxena who achieved his PhD in the US and worked in global corporates such as Eli Lily.â€? Healthcare continues to dominate life sciences investments Says Utkarsh Palnitkar, MD, Pluripotent Capital and ED, Centrum Capital The life sciences sector has been to a large extent insulated from the recession that cast a long shadow on the industry. Having said that, the industry has its own set of challenges. The situation across the sector in India is rapidly evolving, with a growing emphasis on early stage development. The number of enterprises in the early stage development has certainly seen an increase. Funding start up enterprises continues to be an area of concern. Enterprises focused purely on discovery research still find funding extremely hard to come by, though there has been significant improvement in the number of transactions in this space. Since 2005, $100 million has been invested in early stage companies. The challenges of scale and feasible exit routes continue to haunt such enterprises. The Government of India has significantly increased funding discovery research through a number of schemes launched by it. However, Government funding is spread across the life cycle of enterprises. Development or late stage capital is easier to come by in India. It would be immensely beneficial if the Government could predominantly focus on high-risk enterprises in early stage development. What we need in India is baton exchange program, with the enterprise moving from one set of investors to the next dependent on the level of maturity attained. There is a significant number of HNIs in India who selectively invest in early stage enterprises. However, there is no fiscal incentive for them to do so. If the Government were to incentivize early stage investment as it is expected to do in the case of first time investors in mutual funds, a lot of risk capital can be made available to start ups. Moreover, if a mechanism could be evolved for creation of high-risk investment vehicles with commensurate incentives, this would go a long way in unlocking resources. Across the spectrum of life sciences, healthcare continues to attract a large share of private equity, primarily due to the large demand supply mismatch. Between January 2010 to April 2012, Private equity of $700 million was invested in the life sciences sector, of which healthcare accounted for the majority share (60 percent), followed by Pharma. Going forward one may see some level of consolidation, which will also provide an exit route to early investors. In summary, the life sciences space continues to be an attractive proposition to the investing community. Individual segments offer varied promise, with some such as healthcare related appearing more attractive as opposed to those in discovery. ]]> <![CDATA[Is CSIR the fountain head of innovation in the country?]]> https://biospectrumindia.com/news/95/1077/is-csir-the-fountain-head-of-innovation-in-the-country.html https://biospectrumindia.com/news/95/1077/is-csir-the-fountain-head-of-innovation-in-the-country.html Fri, 05 Oct 2012 15:10:00 +0530 Ch. Srinivas Rao The author is Editor of BioSpectrum srinivasch@cybermedia.co.in Council of Scientific and Industrial Research (CSIR) celebrated its 70th Foundation Day on September 26, 2012. Prime Minister Dr Manmohan Singh in his address at the CSIR Foundation Day function complimented the Council on its unique attempt to make healthcare affordable by exploiting the power of open source drug discovery. â€œAs a concept, this is a global first and the world has turned from skepticism to partnership. After India embraced globalization, introduced economic reforms and joined the WTO, CSIR quickly emerged as the flag bearer of the Intellectual Property movement in our country and became the single largest holder of US and European patents. The Council, in recent years, has also become a world leader in specific domains of biotechnology and recombinant DNA products,â€? said Dr Manmohan Singh. There is no doubt that CSIR has been at the forefront of creating indigenous capacity and enabling India's industrial development. However, very little was known about its tryst with Intellectual Property (IP), especially on details related to the status of patents, the success story of licensing, the royalty income, etc. Vayalar Ravi, Minister of Science & Technology and Earth Sciences and Vice President, CSIR on the occasion revealed a few interesting details. â€œCSIR is granted 90 percent of US patents granted to any Indian publicly funded R&D organization. About 9 percent of its patents are licensed-a number which is above the global average. Amongst its peers in the publicly-funded research organizations in the world, CSIR is a leader in terms of filing and securing patents worldwide. Major industry houses of India and innumerable MSMEs have benefited from CSIR. The scientific staff of CSIR only constitute about 3-4 percent of India's scientific manpower but they contribute to 11 percent of India's scientific outputs,â€? said Ravi. Prashant Reddy, who is working towards a LLM degree in Law, Science and Technology at Stanford Law School, informs me that more than 400 patents have been licensed over the last 10 years. It may be noted that Reddy has followed up with CSIR for almost six months through RTI applications, appeals and reminders, to get more details on the patents. CSIR finally provided him with a comprehensive, lab-wise, list of all the patents that it has licensed in the last 10 years this August. â€œThe only information not provided was royalty figures. I'm glad to note that, contrary to popular opinion, CSIR has actually been quite successful in licensing its patents. It was a pleasant surprise to browse through the list of over 454 patent licensing deals,â€? said Prashant Reddy. The technologies licensed by CSIR labs spread across several areas including pharmaceutical inventions, medical diagnostics, water filtration, food technology, mining and construction technologies, and chemical technologies. These have been licensed to a diverse set of companies both in India and abroad. Some of the licensees in life sciences include Cadila Pharmaceuticals, Nicholas Piramal, Nostrum Pharmaceuticals, DRDO, USV Ltd, Tata Chemicals, Ranbaxy, Shreya Life Sciences, and Emcure Pharmaceuticals. â€œThe information disclosed in response to my RTI application reveals that CSIR does seem to have an active network to licence its patents. It would be interesting to study how CSIR has been marketing its patents so far. The only problem seems to be that there is little co-ordination at the national level since each CSIR lab seems to act in isolation from the larger CSIR network,â€? writes Reddy. CSIR clearly has great potential, provided its top leadership can get its act together. ]]> <![CDATA[Biopolicy]]> https://biospectrumindia.com/news/95/1139/biopolicy.html https://biospectrumindia.com/news/95/1139/biopolicy.html Fri, 05 Oct 2012 15:07:00 +0530 â€œThe government is mulling a proposal to allow foreign direct investment (FDI) in the pharmaceutical sector in the next few month's, said Saurabh Chandra, secretary of the Department of Industrial Policy and Promotion (DIPP) at the Associated Chambers of Commerce and Industry of India (ASSOCHAM) event held in New Delhi on August 29, 2012. Earlier in July, an inter-ministerial panel had finalized the new FDI guidelines for the pharma industry, a move that was expected to clear the way for more than 3,000 crore worth of FDI proposals. â€œThere is a need for the government and the industry in general to join hands to reverse the downtrend of industrial production index which has primarily been led by capital goods and decline in production of commercial value,â€? said Chandra. Video consent, soon to be must for CROs The Indian health ministry will soon amend the â€œSchedule Yâ€? of Drugs and Cosmetics Rules to make a provision for audio or video recording of the informed consent in clinical trials. As per reports, once the necessary amendments are done by the ministry in this regard, the recording of informed consent will become mandatory in the country. Besides this, the procedure of providing information to the subject and his understood consent should be maintained by the investigator for record. Aimed at ensuring proper care for the clinical trial participant, the video consent will record that the subject has been well informed about the pros and cons of the clinical trial and participation is voluntary. This will also serve as a proof in case there is any trial death issue later on. Govt to improve regulatory framework â€œThe ministry of health is working on transparency and accountability to encourage all manufacturers to go for trials. The central government's 12th Plan will fund state regulators to strengthen their infrastructure and man power.â€? This was stated by Arun Kumar Panda, joint secretary, Ministry of Health and Family Welfare, Government of India at a conference - PharmTech 2012 held in New Delhi on September 14, 2012. Panda, who is responsible for drug regulation, spoke of conducting effective drug trials. Organized by PHD Chambers, the meeting brought together senior government officials, captains from Indian pharmaceutical industry and technical experts to present views on technology innovation and upgrade. Experts delved into hot topics of the pharma industry including supply chain effectiveness, allotment of costs to R&D, drug control and inspection and FDI. The conclave witnessed discussions on subjects including intellectual property rights, FDI, business process re-engineering and R&D scale up among others. Rajasthan halts GM mustard trial The government of Rajasthan has recently conveyed its decision to withdraw the no objection certificate (NOC) which was issued to the Centre for Genetic Manipulation of Crop Plants (CGMCP), University of Delhi for the conduct of second season Biosafety Research Level trial with GM Mustard. The trials had been earlier approved by the Genetic Engineering Appraisal Committee (GEAC). On perusal of the directions issued by the Government of Rajasthan, it was noted that no new facts regarding non-compliance of biosafety measures or evidence of harm have been cited as a reason which compelled them to withdraw their NOC. Govt to set up drug controller office The department of AYUSH, Ministry of Health and Family Welfare, Government of India, has proposed to set up a Central Drug Controller's Office for AYUSH drugs to enhance the acceptability and export of ayurveda, yoga and naturopathy, unani, siddha and homoeopathy (AYUSH). It will be headed by additional drug controller general of India (AYUSH). The expenditure finance committee (EFC) chaired by the secretary has approved the proposal for creating 40 posts in the proposed Central Drug Controller's Office (AYUSH) for supporting engagement of 330 scientific manpower in the state drug testing laboratories. The matter for creation of required manpower is under examination in consultation with the department of expenditure and an allocation of 80 lakh is made in the annual plan 2012-13 for the purpose. FDA APPROVALS & PATENTS Cadista gets US FDA nod Noida-based Jubilant Life Sciences announced that one of its US subsidiaries Jubilant Cadista Pharmaceuticals has received approvals from the US Food and Drug Administration (US FDA) for four dosage formulations. These include escitalopram tablets olanzapine orally disintegrating tablet losartan potassium tablets USP, and hydrochlorothiazide tablets. Escitalopram is used for acute treatment of generalized anxiety disorder and acute and maintenance treatment of major depressive disorders. Venus bags patent for Vancoplus Chandigarh-based Venus Remedies, a leading research based global pharmaceutical company, has secured its first patent from Canada for its novel antibiotic adjuvant entity â€œVANCOPLUSâ€?. The patent has been granted by the Canadian patent office and is valid up to May 2027. The company is planning to launch the product in Canada in the next two years. Venus has already been marketing Vancoplus successfully in India and few of the merging markets across the globe. As per a research report published by Canadian Antimicrobial Resistance Alliance (CARA), the community-acquired Methicillin-resistant Staphylococcus aureus (MRSA) cases have increased significantly from 19.5 percent in 2007 to 38.1 percent in 2010 and 40 percent of the cases have arisen from the community with increase in infection, among children and young adults. US FDA OKs Agila's facility Agila Specialties (Agila), injectables unit of Strides Arcolab Limited, announced that it has received US FDA approval for its Polish Sterile facility. This state-of-the-art facility located in Warsaw, Poland, manufactures vials, ampoules, pre-filled syringes and lyophilized injections. With this approval all the eight global sterile injectable sites of Agila are now approved by the US FDA and EU authorities and places Agila amongst the largest global capacities for sterile injectables. Shipments from the Polish facility will commence within Q4 2012 and will run in full capacity by Q1 2013, as product transfers have already commenced. Venkat Iyer, CEO, Agila Specialties, said, â€œThis approval for our Polish sterile facility offers significant flexibility to our manufacturing which is currently experiencing strong demand on a worldwide basisâ€?. ]]> <![CDATA[Indian biotech: $100 billion gorilla in 2025]]> https://biospectrumindia.com/news/95/1023/indian-biotech-100-billion-gorilla-in-2025.html https://biospectrumindia.com/news/95/1023/indian-biotech-100-billion-gorilla-in-2025.html Fri, 05 Oct 2012 14:56:00 +0530 A government-industry joint report has predicted that India's emerging biotechnology sector will become a $100 billion giant from its current $4 billion level in the year 2025 â€œA dynamic and vibrant biotechnology industry would be one of the main engines of innovation in India and will establish the country as a global destination for innovation with economic spillover effects such as creation of a large biotechnology manufacturing industry, high technology skilled jobs and supporting an ancillary industry that feeds the innovation engine,â€? summed up the report commissioned by Indian government's federal Department of Biotechnology (DBT) and prepared by the Association of Biotechnology-Led Enterprises (ABLE). The 2025 industry revenue number has been extrapolated from the 2012 BioSpectrum-ABLE Biotech Industry Survey which revealed that the sector had a compounded annual growth rate (CAGR) of 24 percent since 2003. With some more support from the government, with more favorable policies, the industry could grow at a CAGR of 30 percent or more in the next decade. This will nudge it past the $100 billion mark by 2025, predicts the report. â€œThe potential for India to be a global innovation hub especially in biotechnology exists. The Indian biotech industry has also shown that when proper support systems exist they can deliver scaled up innovative products that are affordable and are of high quality,â€? says Dr Satya Dash, who authored the report, â€œIndian Biotechnology: The Roadmap to the Next Decade and Beyondâ€? early this year as the chief operating officer of ABLE. Added Dr M K Bhan, secretary, DBT, â€œThe government has established several innovative industry focused schemes such as SBIRI, BIPP and Ignition Grant. These programs are helping the industry to proactively incorporate innovation as the driving force for R&D, enabling the industry to build capacity for future growth and are creating platforms for positive collaborations between industry and academia for translational biology.â€? Of course, this is not going to happen if the business as usual scenario continues. An institutional and structural framework has to be built to help the country achieve its potential as a break out nation for biotechnology innovation. According to the report, the five guiding principles the government should follow to make this happen are: Create a strong, streamlined and regulatory foundation that fosters innovation. Reshape and build government infrastructure to build capacity for research and development and facilitate translation and commercialization potential. Facilitate technology access as well as market access for innovative products to achieve scale through public procurement. Promote biotech entrepreneurship and provide a channel to access risk capital for all stages of biotechnology product lifecycle. Nucleate and foster networks and triple helix collaborations. One of the key suggestions is to set up a â€œCentre for Biotechnology Policy and Regulatory Sciencesâ€? on the lines of the Institute for Manufacturing in University of Cambridge, UK which brings together all the elements of regulation, policies, industry-government interactions, academia-industry interactions and business strategy. The report has also called for setting up fully-equipped technology-transfer offices in all science and technology research centers. The government has declared this to be the Decade of Innovation. â€œ Biotechnology is synonymous with innovation,â€? commented Dr Vijay Chandru, who headed ABLE from 2009 to 2012 and Dr P M Murali, current President of ABLE in their foreword in the report. â€œThe innovation imperatives are clear enough-biosimilars and diagnostics for affordable healthcare, integrated traditional medicine, green biotech for less dependence on petroleum, bioremediation for environmental recovery, agricultural productivity and value addition, leapfrogging with genomics, synthetic biology and biomedical informatics.â€? In the past, India's biotech industry has come into its own and laid the foundations for the future. It is time now to build on these foundations and embrace the future with a strong commitment focused on innovation. Narayanan Suresh ]]> <![CDATA[The genomics technopreneur]]> https://biospectrumindia.com/news/95/1810/the-genomics-technopreneur.html https://biospectrumindia.com/news/95/1810/the-genomics-technopreneur.html Fri, 05 Oct 2012 14:54:00 +0530 Genomics Dr Raja C Mugasimangalam president and CEO, Genotypic Technology, Bangalore Dr Raja Mugasimangalam is a technologist turned entrepreneur in the field of genomics. The entrepreneurial spirit in him to start a research-based technology firm for developing new methods in molecular biology led him to set up Genotypic Technology, along with Dr Sudha Rao in 1998. This is one of the first Genomics companies in India to offer customized â€œone-stop solutionâ€? to address complex research questions by applying genomics. Holding his Masters in Biotechnology from Madurai Kamraj University in 1988 and PhD in Biotechnology in 1994, Dr Raja Mugasimangalam worked at the Weizmann Institute of Science in 1996 as post doctoral researcher in the Human Genome Project. Later, he completed his post doctoral research at Sidney Kimmel Cancer Center, SanDiego, after which he worked as a human genome scientist at the Argonne National Lab till 1998. He then moved on to QBI, Israel, which is one of the first human genome research companies in the world. He gained rich experience by working in companies such as Quark Biotech, which he leveraged to develop methods for constructing microarrays for studying drug toxicity in rat diabetes model. Recalling the early part of 2000, Dr Mugasimangalam said, â€œWe embarked on a project funded by Astra Zeneca Research Foundation to predict drug binding pockets with only the sequence information and no structure. From there on, be it the first printed microarrays in India in collaboration with Institute of Genomics and Integrative Biology, Delhi or certifications for Genomics services, we have tested and optimized on many such technologies.â€? Under the guidance and leadership of this scientist turned entrepreneur, the company attained several peaks. Genotypic Technology is an ISO as well as Agilent certified facility. Their bioinformatics team handles huge data sets with complex mandates with relative ease. Genotypic has also become the first certified service provider for Ion Torrent's personal genome machine in India. Speaking about the challenges, Dr Mugasimangalam said that, â€œWe have no issues in finding the right people to deal with such complex techniques. Our internal training and mentoring ensures they scale up pretty quickly to handle the challenges in genomics. Currently, we can sequence hundreds of microbial genomes or a few human genomes in a week's time. Analyzing the sequence data and converting it into knowledge is a challenge and our teams are well equipped with the right computation tools and capabilities. The multiple in-house genomics platforms, wet labs and the bioinformatics teams for array design, array analysis, genome informatics and close working conditions allows Genotypic's teams to get the big picture quickly.â€? â€œCompanies are happy to work closely with Genotypic when it comes to genomics research as we specialize in converting the technologies into real life applications and help them take the technologies beyond standard protocols. Genotypic is now initiating programs for plant genotyping and human diagnostic services, taking genomics directly to the consumer,â€? concludes Dr Mugasimangalam. Vipul Murarka ]]> <![CDATA[The biomolecules innovator]]> https://biospectrumindia.com/news/95/1617/the-biomolecules-innovator.html https://biospectrumindia.com/news/95/1617/the-biomolecules-innovator.html Fri, 05 Oct 2012 14:49:00 +0530 Bioprocess Engg Dr Amulya Kumar Panda scientist, product development cell, National Institute of Immunology, New Delhi Dr Amulya Kumar Panda cherishes his 20 years of research experience in the area of bioprocess engineering. He has been deeply involved in research concerning the applications of chemical engineering processes to biological processes for production, purification and formulation of proteins and biomolecules. Currently working as a senior scientist at the product development cell, National Institute of Immunology (NII), Dr Panda is spearheading research efforts into various application aspects of biomolecules. The other areas that he focuses are refolding and high throughput purification of bioactive protein from inclusion bodies of E coli. He is also looking at formulations and delivery of therapeutic proteins, DNA and vaccines using polymeric particles. After completing his MTech in chemical engineering from the Indian Institute of Technology, Chennai in 1985, Dr Panda went on to pursue doctorate in biochemical engineering and biotechnology from the Indian Institute of Technology, Delhi in 1991. Later, he continued his research at NII, while also being a visiting scientist at the Department of Chemical Engineering, University of California at Berkeley, CA, USA in 1994. He was also a part of the research project at the Laboratory of Nanobiology, College of Pharmacy, Nebraska Medical Center, USA in 2004. Apart from publishing 50 research papers and 8 chapters, Dr Panda holds 10 patents in his area of expertize. Among the numerous awards conferred on him, the major ones include the Young Asian Biotechnologist Prize by the Society for Biotechnology, Japan for the year 2004; Excellence in Scientific Achievements, 2001 from NII; and Biotech Product and Process Development and Commercialization Award, 2001 by the Department of Biotechnology. Dr Panda has also been associated with various committees and panels. He is also the editorial board member of International Journal of BioSciences and Technology. Dr Panda and his team have been working hard to develop a cheap alternative for wound management. His creation, the biodegradable polymer particles encapsulated with drugs along with antibiotic and growth factors, can be self-assembled into bio-membranes in a single-step at room temperature, and can be used immediately as artificial skin substitutes for burns and wound treatments. For his efforts, Dr Panda and his team won the India Innovation Pioneers Challenge (IIPC-2008) award, organized by the Department of Science and Technology, in association with Intel India and Indo-US Science and Technology Forum in August 2008. On choosing this subject, Dr Panda said, â€œWe discovered the process of membrane formation using polymeric nanoparticles on which we were working for a long time for vaccine delivery. Because of the multidisciplinary structure of my research group, we were able to change the focus of our research to utilize the membrane for wound healing.â€? â€œIndia needs two type of technological innovations: one is 'nice to have it' and the other is 'need to have it'. Our innovation belongs to the later category,â€? concludes Dr Panda. Rahul Koul ]]> <![CDATA[The champion in biologics]]> https://biospectrumindia.com/news/95/7468/the-champion-in-biologics.html https://biospectrumindia.com/news/95/7468/the-champion-in-biologics.html Fri, 05 Oct 2012 14:42:00 +0530 Biologicals Dr Gautam Daftary managing director, Bharat Serums and Vaccines, Mumbai With a rich product portfolio that includes many firsts in India as well as in the world, and with more than three innovative products in advanced stages of clinical development, Bharat Serums and Vaccines has carved out a prominent space for itself in the world of biologicals and recombinants. Spearheading its research initiatives for more than two-and-a-half decades is Dr Gautam Daftary, managing director, Bharat Serums and Vaccines (BSV). A medical doctor by training, Dr Daftary says that he did not originally intend to practice medicine. Instead, on completion of his studies, he underwent a number of trainings in leading institutes worldwide, to familiarize himself with techniques in protein chemistry for the development of blood products, that were the earliest offerings at BSV. Dr Daftary has since then completely focused on research and development (R&D) aspects, while his brother Bharat Daftary manages the business side of the family-owned company. Under his able leadership, BSV has amassed a portfolio of more than 15 patents and several others that are yet to be granted. A focus on niche products, addressing unmet needs, has resulted in a number of challenging research projects being undertaken by Dr Daftary and his team. He said, â€œThe challenges have driven us to break technological barriers so far. If they say we can't do it, it makes us want to do it even more. I liked the challenge that was presented to us for pursuing R&D in things other than blood products. We worked on it, and learnt as we went along to then successfully market Propofo, a lipid emulsion anaesthetic in 1997, a first in India where the technology was developed completely in house.â€? Dr Daftary heads the R&D that originates in three locations namely, India, Dusseldorf, (Germany) and San Jose, (USA). One of the innovate products to result from there has been, a recently launched Ulinastatin, a biosimilar for the treatment of sepsis. Lack of treatment options prompted BSV to carry out research in natural products at Dusseldorf to develop the product isolated from urine, a serine protease that suppresses polymorphonuclear elastase (PMNE). Dr Daftary is also credited with starting what was arguably India's first contract research organization (CRO), way back in 1995. Over a glass of wine with his mentor Dr Ransberger, Dr Daftary agreed to conduct a small clinical trial for an anti inflammatory compound. What began by chance then, has now grown to be one of the largest Indian CROs, with Dr Daftary as its chairman. Another product in advanced stages is the Amphotericin B emulsion, again a first-of-its-kind in the world. The molecule has recently completed phase III clinical trials for the treatment of kala azar. As compared to the innovator molecule of Amphotericin B which has to be administered over four doses, BSV's formulation can be given in a single dose of 15 mg, because of the improved safety associated with it. Moving ahead, Dr Daftary, has plans to develop recombinant versions of the existing products as well as newer ones to address the rising costs associated with natural materials. Manasi Vaidya ]]> <![CDATA[Probiotics help cure vaginosis]]> https://biospectrumindia.com/news/95/2588/probiotics-help-cure-vaginosis.html https://biospectrumindia.com/news/95/2588/probiotics-help-cure-vaginosis.html Fri, 05 Oct 2012 14:35:00 +0530 Hyderabad-based Microbax India successfully completed a SBIRI funded project in collaboration with Talwar Research Foundation to manufacture a better and safe alternative for vaginosis in women AVDS (Abnormal vaginal discharge syndrome) is a very common disorder worldwide. It has been reported that 30 percent of the women from urban areas and 62 percent of rural women suffer from this syndrome, which is caused by a wide variety of microorganisms. Vaginosis is widely prevalent in India and elsewhere in the world. Though antibiotics and drugs are available to cure vaginosis, they also eliminate the beneficial probiotic lactobacilli resident in the vagina. The present project will bring out products for replenishing probiotics of desirable properties in vagina of the women lacking these and also curing the local vaginal infections. To find a solution, Microbax India based at Hyderabad, initiated a project in 2008, on industrial manufacture and marketing of selected probiotic tablets containing Lactobacillus strain(s) along with polyherbal microbicide for relieving vaginosis, vaginitis and replenishment of probiotic Lactobacillus strains. The research and development (R&D) team at Microbax comprised of five scientists. The project was driven in collaboration with Talwar Research Foundation under the guidance of Professor GP Talwar, founder and director of National Institute of Immunology. While the research work at Talwar Foundation involved the isolation of the microorganisms, the large scale production was carried out by Microbax. Explaining further on technology, Vikas Rajurkar, CEO, Microbax said, â€œThe technology has been perfected and will help to bring into market a very stable product which has been tested for its efficacy. As per our knowledge, no other similar product exists in the market.â€? The funds amounting to a total of 7 crore from Small Business Innovation and Research Initiative (SBIRI) scheme of Department of Biotechnology (DBT) enabled the company to procure and install sophisticated fermentors and other equipment which will be used to produce high quality products. Appreciating the government support, Rajurkar said, â€œWe are thankful to the DBT and all the people behind the SBIRI scheme. We have not only received the funding, but also mentoring from the project monitoring committee members which has helped the project. Biotech Consortium India Limited (BCIL) has also been very helpful.â€? Way forward Microbax will produce for the first time in India, the vaginal probiotic capsules containing strains of Lactobacilli. The company will utilize submerged fermentation technology and lyophilization to produce the probiotics on a large scale. The strains have been selected by time resolved fluorescence (TRF) after conducting probing clinical trials at two premier institutes in the country. The project has been completed and the product is all set to be launched. Speaking further on PPPs in biotech, Rajurkar added, â€œThese partnerships will definitely result in bringing into the market innovative products, as the schemes such as SBIRI launched by DBT provide grants and loans at nominal interest rates for projects in â€œproof of the conceptâ€? stage. This will help the entrepreneurs to take the risk and work on novel technologies and products. Our project is the proof of such partnership between a research institute and industry.â€? Rahul Koul ]]> <![CDATA[Affordable treatment for AMD]]> https://biospectrumindia.com/news/95/3971/affordable-treatment-for-amd.html https://biospectrumindia.com/news/95/3971/affordable-treatment-for-amd.html Fri, 05 Oct 2012 14:34:00 +0530 The BIPP funding from DBT has boosted the research efforts of Hyderabad-based Clonz Biotech to find a low-cost treatment option for age related macular degeneration (AMD) disease A large number of aged population is affected by the age related macular degeneration (AMD), which results in the loss of vision in the center of the visual field (the macula) because of the damage caused to the retina of eye. Among the widely used options for the treatment of this disease is Ranibizumab, a recombinant humanized anti-VEGF monoclonal antibody fragment (recombinant huFab V2). Currently, this product is being produced in E.coli bacterial cells by various companies including Genetech and Roche. However, the major bottleneck is the high cost of production, leading to a highly priced product in the market. Aiming to address this issue, in October 2011, Clonz Biotech, which is located in Hyderabad, initiated a project on production of Ranibizumab, the anti-VEGF monoclonal antibody which is expressed in the yeast, Hansenula Ploymorpha. The project received funding worth 84.51 lakh from the Biotechnology Industry Partnership Program (BIPP) of DBT, of which 33.8 lakh came as grant-in-aid and the remaining 50.7 lakh was received as loan. This proved to be very useful for the company to carry forward the project with more focus on getting the proof of the concept during the initial stages. The basic objective is to produce the huFab-V2 fragment (containing heavy and light chain fragment without Fc constant region) in Hansenula yeast and the product is secreted into the medium. This step makes purification of the correctly folded protein easy and moreover, there is even possibility to produce it in high quantities, which ultimately leads to reduction in costs. Explaining the technology, Dr K Sreenivasu, vice president, R&D, Clonz Biotech, said, â€œAfter the Clonz Biotech research and development team developed the clones for Ranibizumab, we needed it to produce the same in fermentor and then to characterize the purified protein by comparing it to the innovator product.â€? â€œAlso the Hansenula technology from Artes was used for the vectors and host system. The genes were cloned into the Hansenula vectors and the DNA was then transformed into the Hansenula yeast. Further, the best producing clone was screened by enzyme linked immunosorbent assay (ELISA) titre. The protein was produced by glycerol/methanol induction and after correct refolding, it is secreted into the medium. Then it is purified from the medium by column chromatographic techniques,â€? Dr Sreenivasu added. Way forward Highlighting the importance of public private partnerships, Dr Sreenivasu opined, â€œFor biotech industry in India, these partnerships are very useful for the up-coming and start-up biotech companies. This is of really great use to us.â€? The current status of the project is that the clones have been developed successfully in the yeast vectors and the team could see the protein expression in the western blot as an evidence to the concept. The successful completion of the project can produce exceptional results. Besides leading to the substantial decrease in the final product prices, the outcome can serve as an example for future possibilities in many other disease conditions. Rahul Koul ]]> <![CDATA['Our focus is to drive quality in diagnostics']]> https://biospectrumindia.com/news/95/1087/our-focus-is-to-drive-quality-in-diagnostics.html https://biospectrumindia.com/news/95/1087/our-focus-is-to-drive-quality-in-diagnostics.html Fri, 05 Oct 2012 14:18:00 +0530 Lance Littlechairman and MD, Roche Diagnostics, India & South Asia Headquartered in Basel, Switzerland, Roche is a leader in research-focused healthcare, with combined strengths in pharmaceuticals and diagnostics. Roche Diagnostics began its journey in India in January 2002 through the of global acquisition of AVL Biomedical, leaders in blood gas and electrolytes testing market. Having operated in India for a decade, the company has clocked revenues of about 440 crore in 2011 growing at about 13 percent. Recently it announced the appointment of Lance Little as the chairman and MD of Roche Diagnostics India and South Asia. BioSpectrum spoke to Little about the market opportunities and company's plans for the region. Q How do you differentiate the Indian market from other markets such as Thailand and New Zealand?  Little:   In context to the laboratory diagnostics business, all countries are on the same platform. New Zealand with a population of 4.2 million people is a consolidated environment, as far as labs are concerned; primary and secondary healthcare are publicly funded and it is a very controlled, low-growth environment. The challenge lies in being able to increase the market share. Thailand has a combination of government-funded healthcare and out-of-pocket payments and also has a good quality user base. But again, Thailand faces similar challenges like India, when it comes to healthcare access to approximately 60 million people and with a significant population in rural component. In India, we have a world-class and high-end lab facility. However, the challenge is when we look at the credentials of the laboratories present. There are about 40,000 - 60,000 labs in the country but, only approximately 400 labs are accredited by National Accreditation Board for Testing and Calibration Laboratories (NABL). These labs have to be consistent in their performance. Therefore, the focus that I want to bring to India is the experience from the other two markets to build and drive the quality in the labs here, so that more people can benefit from quality diagnostics. This is the fundamental principle and it can be accomplished by moving away from the traditional trader type outlook as a supplier to being partner-friendly to our customers. Q How do you see the growth for Roche Diagnostics? What are the driving factors?  Little:  We expect our business to grow in the range of 20 to 24 percent over the next few years, higher than the average industry growth. Some of the predominant factors driving the market growth in these countries include increased health awareness and accessibility, with the expansion of existing labs. Additionally, private entrepreneurship in setting up of laboratories and hospitals is complimenting the initiatives of the government, thereby leading to an increase in quality of diagnostics and treatment. Q Traditionally Asian countries are very susceptible to price. What is your take on this and what strategies do you have in mind to take the company on growth track?  Little:  We have to make sure that we remain competitive. The Indian diagnostics market is a price-sensitive environment. That's the way it is. We just have to manage the business appropriately. But the healthcare expenditure is an interesting one, because as we understand from the latest government announcements on the next Five Year Plan, that healthcare spend has been increased from 1.4 percent to 2.5 percent of gross domestic product (GDP). This will allow an increasing number of people to access the healthcare and given that 70 percent of clinical decisions are made in conjunction with diagnostic information, I can realize the increasing demand for high quality diagnostic testing. Q How do you see the competition in the diagnostics market here and in South Asian region?  Little:  We have competitors in India as we have globally. Everybody has their space within their various product portfolios and the scenario is no different in India. But, the question is about maintaining the quality of products and systems to make sure if we fit it right for the Indian environment. We are a significant player in many segments including centralized diagnostics, point-of-care, tissue diagnostics, molecular diagnostics, as well as life sciences. Our strength is our quality and our focus will be to partner with the laboratories in India by bringing high-quality technology. Q Looking at the government of India's plan, what streamlines, if implemented by Roche, will help it to maintain high growth rate?  Little:  All of our diagnostic businesses are performing well with the centralized diagnostics and near patient testing showing a very strong growth exceeding our expectations. We hope to continue as we move ahead into a partnership model with our customers and add value through long term relationships, with a drive for excellence in laboratory services. Q Can you elaborate on some of your plans for the future?  Little:  We aim to strengthen our internal processes to support high quality growth by working on sustainable relationships. Diagnostics testing will not only increase as healthcare access increases, but new high quality tests and technologies will be available which will give clinicians more tools to treat patients. We will continue to focus on areas of unmet medical need and in particular there is a lot to do in blood screening and cervical cancer screening. ]]> <![CDATA['How do I trust the credit ratings?']]> https://biospectrumindia.com/news/95/1707/how-do-i-trust-the-credit-ratings.html https://biospectrumindia.com/news/95/1707/how-do-i-trust-the-credit-ratings.html Fri, 05 Oct 2012 14:16:00 +0530 Dr Murali P Muthuswamy,president, ABLE Political events in India and the government's lack of conviction on policy matters have taken their toll on India's image as an attractive investment decision. The change in the country's credit rating outlook by global credit rating agencies has further dealt a blow. Dr Murali P Muthuswamy, president, Association of Biotechnology Led Enterprises (ABLE); MD and CEO of India operations, Evolva Biotech, says that the outlook is all but dim for the bioscience industry with a growth rate hovering around the 20 percent mark. In an email interview with BioSpectrum, he talks about whether the scale down and threat of junk rating has affected investor sentiments in the biosciences industry. Q Do you think the change in India's credit rating outlook by Standard & Poor's has affected the pharmaceutical and biotechnology industries?  Dr Murali:  To answer this question let us look at some of the present figures for pharma and biotech sectors in India: As per the 10th annual BioSpectrum-ABLE Biotech Industry Survey for India this year, â€œAmidst uncertain economic conditions, the biotech industry has performed creditably to cross the $4 billion (20,000 crore) revenue mark for the first time ever. It is clear that the industry growth will hover around 20 percent growth rate in the near future. Many other industry segments will be happy to have such a steady growth rate. This translates to a compounded annual growth rate (CAGR) of 24.18 percent between 2002 and 2012â€? Other reports have stated that an opportunity worth $70 billion in similar biologics beckons India's biotech industry as we approach the â€œpatent cliffâ€? years of 2015-16 Again, India's pharmaceutical industry has witnessed a robust growth from $11.4 billion in 2010 to $13 billion in 2011 to $17.4 billion in 2012 with a scorching pace of growth of 15 percent. The industry ranks 3rd in terms of volume globally. Projects worth more than $1.2 billion are currently under implementation at various stages, suggesting massive investments by Indian pharmaceutical companies Also, it is important to note that the healthcare industry has grown from $71.8 billion in 2011 to $77.3 billion in 2012 at a growth of 7.6 percent (11% in rupee terms) The medical devices market has grown from $3 billion in 2011 to $3.2 billion in 2012, growth of 8% (12.2% in rupee terms) So, to me the answer is that this sector has largely not been affected. However, India's pharmaceutical Risk/Reward Rating (RRR) score has dropped from 56 in Q212 to 54.4 in Q312 due to fall in its industry risks and country risk scores. As a result, India's position on the proprietary ranking system is now 10th out of 18 countries, falling a position behind New Zealand. Q Do you think credit ratings from such agencies matter?  Dr Murali:  To understand ratings, it is important to look back in history. Credit agencies have come under fire for giving no indications or favorable ratings to firms such as Enron Corp and Lehman Brothers before their collapse. In 2009, Moody's issued a report titled, Investor fears over Greek government liquidity misplaced; within six months, the country was seeking a bailout. Recently, HDFC chairman, Deepak Parekh suggested that these rating agencies need to be â€œratedâ€?. Not all of them have sufficient exposure to the dynamics and intricacies of this industry due to diversity and complexity. Also, there are several pockets of growth that are still not tapped, and it is very unlikely that such agencies may even know about it. Many such ratings are a rear view mirror and may not foretell about future prospects accurately. Also, there are clear cases where rating agencies have not got their data right. So, my worry as a citizen and not being an economist is, how do I trust these ratings? Also, how much importance should I give them? Q Has there been a negative impact on foreign direct investment in the pharmaceutical and biotechnology sectors because of the negative credit rating and government flip-flops on FDI?  Dr Murali:  In August, India's foreign investment approval authority cleared eight pending proposals of foreign drug companies to buy stakes in local companies. As per the decisions from inter-minsterial group on FDI in pharma, India allows 100 percent FDI in greenfield projects and 49 percent in brownfield projects by the automatic route, while above 49 percent in brownfield requires approval from the FIPB. The group has also decided that a multinational firm buying a stake higher than 49 percent in an Indian pharma company will maintain the same level of investment in research activities and production of essential medicines for five years. According to some officials, the foreign partner that will gain substantial shareholding in the company will have to assure the government that none of the essential drugs produced by the Indian company will be discontinued after foreign investment. They may also be asked to invest five per cent of their turnover in research and development relating to drug that address India specific health problems. Globally, several countries look at India for providing affordable healthcare and it is even more important to do so for Indian citizens. The government reserves its right to take decisions that are most favorable to its citizens. From this perspective, greenfield projects may be more beneficial to India, given its potential to create new jobs and an ecosystem around it rather than brownfield projects. Q If you were to give a five-point plan for the government to encourage biotech what would it be?  Dr Murali:  Bring in a transparent and path- breaking regulatory landscape Incentivize financial institutions that invest into this sector. Usher in a climate where SMEs can raise capital from the market. Biotech start ups make losses for a decade before they start making money Provide impetus for Indians living abroad to return and work for the country Starting a company and closing one should be simple. Also adequate infrastructure to foster growth of SMEs must be put in place by the government Boost for â€œintegratedâ€? cold storage warehouses at major ports are required to facilitate temperature sensitive biotech shipments in bulk. Also, the time taken by the customs could be reduced for regular shipments. Q What are the major events in the coming years that could be game changing for the biotech industry?  Dr Murali:  The cost of sequencing is coming down rapidly. Personalized medicines will therefore be the way forward. Similarly, regenerative medicine will start emerging as an important area to repair and provide. Manufacturing will shift from the West to Asia, as we would be providing very valuable skills in processes that would make production cheaper.  Note: This interview was conducted several weeks prior to the announce-ment of the new economic reforms by the Union Government on September 21, 2012  Manasi Vaidya ]]> <![CDATA[The report on GM crops sets the clock backwards for Indian agriculture]]> https://biospectrumindia.com/news/95/6362/the-report-on-gm-crops-sets-the-clock-backwards-for-indian-agriculture.html https://biospectrumindia.com/news/95/6362/the-report-on-gm-crops-sets-the-clock-backwards-for-indian-agriculture.html Fri, 05 Oct 2012 14:11:00 +0530 WritesProf. Shanthu ShantharamSeed Technology Center, Iowa State University Ames, Iowa The report of the parliamentary standing committee on agriculture severely indicts the enetically Modified (GM) crops technology, and calls for complete cessation of even field tests that are a crucial part of the research and development activities. Such a damning condemnation of one of the truly transformative technologies of our times without a sound scientific rationale is unprecedented in the annals of Indian agriculture. If accepted as a public policy of the country, it will set the clock backwards and will stifle a decade's growth of the country's agriculture. The report's criticism that GM technology only benefits its purveyors, and does not help India's poor farmers seems to have been borrowed from the anti-GM propaganda, that is not based on any empirical evidence. The report claims to have received thousands of submissions from all stakeholders, but has given a short shrift to the knowledgeable expert voices of the scientific community, who are the most qualified to assess the technology's risks and benefits. In fact, social scientists of the Indian Council of Agricultural Research (ICAR), Centre for Economic and Social Sciences (CESS), Hyderabad, Andhra University, Gokhale Institute, Pune, Indian Institute of Management, Ahmedabad, International Food Policy Research Institute (IFPRI), Washington, and Cornell University have all demonstrated in their scholarly reviews and articles that GM technology and Bt cotton in particular are scale neutral and also have provided empirical evidence to suggest that, this technology, which is endowed in the seeds, benefits all sections of the farming community. The report targets the highly successful Bt cotton as a disaster for Indian farmers, and blames it entirely on farmer suicides in the Vidharbha region, without a shred of evidence. On the contrary, the empirical field data published by the International Food Policy Research Institute (IFPRI), Washington and the Center for Economic and Social Sciences (CESS), Hyderabad and a recent research publication in the Proceedings of US National Academy of Sciences have all provided facts and figures to show that Bt cotton has helped all strata of Bt cotton farmers in India. India today ranks second in cotton production; thanks to the Bt cotton technology. The fact that more than 95 percent of the cotton growing areas in the country is planted with Bt cotton by thousands of cotton farmers, resulting in a 40 percent usage reduction in the total chemical insecticides, that have not been taken cognizance of. The net result is protection of the environment, human exposure to the insecticides, and measurable socio-economic benefits. The above ground realities have been completely ignored by the committee, and it has wrongly recommended that Bt cotton cultivation should be banned in the country. Lopsided Indian agri milieu India's agriculture is considered to be one of the most laggards in the world, according to the UN-Food and Agricultural Organizations. To quote India's eminent agricultural scientist Dr MS Swaminathan, India's green revolution is fatigued, and yields have stagnated since the eighties. India's food security is already at stake, and severe food shortages will follow starkly reminding us of famines of the sixties. Modern biotechnology is one of the two technologies that have come to the rescue of agriculture, the first one being the green revolution, and to foreclose this transformational technological option based on false propaganda, by a committee of parliamentarians is nothing but a recipe for disaster for the nation. The GM crops are not a â€œpanacea,â€? which is something everyone has been saying for decade, but can be an eminent part of the solution. With respect to Bt brinjal that is under an indefinite moratorium, it is foolhardy to believe that India has over 2200 varieties of brinjals that would take care of all future needs of the country. There may be accessions in the gene bank, but there are no more than 200 authentic brinjal varieties in the country, most of which have gone out of cultivation. The fact is that more than 70 percent of brinjals cultivated are hybrids, and Bt brinjal comes not only in hybrids, but also in open pollinated varieties; thanks to the efforts of the two agricultural universities of Karnataka and TamilNadu. As much as it is valuable to have diversity in a crop variety, it is also equally important the method of their cultivation by minimizing the environmental impacts and reducing the carbon footprint. Farmers grow crops that will fetch them good remuneration in the market. If there are no takers for all sorts of varieties, why would anyone be foolish to grow them? For the past several years, Bt cotton has been sold in the range of 750-900 per acre, a price set by the state governments, and all hybrid cotton seed companies also make available non-Bt cotton seeds, if one is interested. Most cotton farmers have opted for Bt cotton for obvious benefits, and therefore there is no demand for non-Bt seeds in certain markets. However, the triumph of Bt cotton is undeniable. It is really mysterious how the committee finds that Bt cotton has been disaster to farmers! Regulations are double-edged sword The report castigates the regulatory system in the country without properly analyzing the scientific basis on which it functions. It recommends the Norwegian system at the behest of the anti-GM lobby. Norwegian system does not work in Norway itself, as that country has never allowed any GM crop cultivation. It is only some academics at the University of Tromso lead by Terje Traavik of GenOk, who have been propagating their own brand of regulatory reviews of GM crops that has not been accepted even by the European regulators. Indian anti-GM lobby likes that system because it does not clear any GM crop to be commercialized. This is a simple mechanism to kill GM technology in the name of biosafety and environmental risk assessment. Regulations are a double-edged sword; it can be used to promote safe deployment of technology or used to kill the technology development. The Bt brinjal decision by the two regulatory bodies of the country, RCGM and GEAC were taken after two expert committee's reports where all scientific concerns had been addressed thoroughly. RCGM and GEAC have acquitted themselves ably, but not in the eyes of the anti-GM lobby who would like to see that India's regulatory system tie up products of biotechnology in regulatory testing from here to eternity. GM technology is not a monopoly of one company as alleged by the chairman of the committee. Six biotech majors are marketing the technology products around the world, and more than forty Indian seed companies are marketing GM crops developed by three different technology providers. The proposed Biotechnology regulatory Authority of India (BRAI) bill has been drafted after several years of public consultations, and it will be a shame to dilute it due to pressure from the anti-GM lobby. The path ahead The chairman gives away his true political colors by saying that government's neo-liberal policies is responsible for India's agrarian crisis, and thinks that modern biotechnology developed by US based MNC will further drag down India's farmers. This is a fallacious political argument that is not based on any empirical data. India is committed to marshaling the biotechnological tools to improve nation's agriculture, environment and public health. It has a dedicated Department of Biotechnology for the past twenty-five years with a multi-million dollar budget to promote developments in biotechnology, and the department has also a definite policy plan in place. All of that will be negated, if this report is accepted. It is a retrogressive report that the government will be wise to discard. Instead, the government should invite real scientific experts and social scientists to draw up a visionary blueprint for launching India's agriculture on a truly progressive trajectory in the 21st century and beyond.  About the author Dr Sivramiah (Shanthu) Shantharam is a visiting professor at the Seed Science Center of the Iowa State University, Ames, Iowa and an international agriculture and agricultural biotechnology consultant. Dr Shantharam has over thirty years of experience as a regulatory scientist (molecular biologist, biotechnologist, plant protection and quarantine specialist). ]]> <![CDATA['Our focus is on game changing technologies']]> https://biospectrumindia.com/news/95/2738/our-focus-is-on-game-changing-technologies.html https://biospectrumindia.com/news/95/2738/our-focus-is-on-game-changing-technologies.html Fri, 05 Oct 2012 13:17:00 +0530 Praveen Guptaexecutive director, PREMAS Biotech Haryana-based, PREMAS Bio- tech is among the first to have adopted a unique business model, with contract research and manufacturing services (CRAMS) running in parallel with biosupplier business under a single umbrella. Earlier this year, the company set up a separate supplier division known as PREMAS Life Sciences that caters to key market segments in India such as life sciences research (both government and private labs), new drug discovery, agribiotech based research and molecular diagnostics. In an interview with BioSpectrum, Praveen Gupta, executive director, PREMAS Biotech, speaks about the various aspects of the company, market trends and future outlook. Q What was the idea behind the creation of life sciences division at PREMAS Biotech? Gupta: As a mandate of developing in-house cutting edge products (like DME) and offering research services (CRAMS), PREMAS started a bio-supplier arm within the group to launch global niche technologies in India. At the very beginning, we partnered with one of the leading global genomics brands, Illumina in 2006 to cater to the then emerging Indian genomics market. In 2011, after witnessing continuous success for four years, we decided to give added focus to this business vertical and hence created a Life Science division to solely concentrate on partnering as well as launching additional high-end research tools in the market. Our strategy is to only associate with game changing technologies that are making a difference in the global life sciences research. We are hoping that this focused approach will help us to getting a higher market share in this growing space. Q Tell us about the current product portfolio, different segments and major clients of the company? After expanding our portfolio, we are having product lines such as array-based solutions for gene-expression, genotyping and epigenetics. The other products are next generation sequencing (NGS) based solutions, in-situ gene expression, single cell genomics, de-novo optical mapping solution, strain typing, multiplex ELISA/protein array, and farm animal diagnostics. We are also currently catering to research in genomics and proteomics, drug discovery and clinical diagnostics segments. Our key customers include Council of Scientific and Industrial Research, Department of Biotechnology, Indian Council of Agriculture Research, Indian Council of Medical Research labs apart from universities, drug discovery, pharma, CRO, diagnostics, and genomics service providers. Q What are the latest trends in the NGS market? How big is it and how are you planning to expand your share? Latest trends in NGS are the development of custom panels for targeted re-sequencing. The disease specific panels for clinical genomics, combining higher read length with higher output and reduced error rates are better and faster data storage tools. These provide better analysis solutions including adoption of cloud to defer high capital cost of servers, metagenomics studies, and single cell genomics. Size of the NGS market in India is difficult to estimate but there has been a major spurt in adoption of NGS by all major genomics labs. Apart from continuing valuable partnership with Illumina, we have also tied up with Fluidigm, which offers high through- put single cell genomics capabilities. We have also partnered with OpGen which offers groundbreaking de-novo genome assembly solutions using optical mapping which allows very fast and accurate strain typing. Q Have you noticed any significant change in the buying behavior of clients? The customers in life sciences are now very well informed and are updated on latest trends. Most customers are now thinking big and compete with the best in the world. The demands of collaborative approaches rather then traditional buy and sell is on the rise. Q What are the challenges faced by biosuppliers as far as the product supply in India is concerned? Few of the challenges include differential custom duty structure for vendors and government customers, high duty tariff, and long custom clearance cycles. Besides that, long sales and purchase cycles, difficulty in getting demo equipments, and tendering process are also the major roadblocks Q Where do you see the company stand in next five years? We have had a CAGR of 112 percent over last five years, which indicates our growth trajectory. We expect that PREMAS will expand both its business verticals to its full potential and mature towards developing partnerships which are beyond distribution remit. We wish to get into joint development for products and technologies locally, which can serve a larger global audience. We also aspire to develop custom genetic panels by partnering with Indian research labs for clinical and agri-biotech sectors that are relevant to Indian context. Rahul Koul ]]> <![CDATA['One of the much awaited launches in the coming days is Aminis platform']]> https://biospectrumindia.com/news/95/2281/one-of-the-much-awaited-launches-in-the-coming-days-is-aminis-platform.html https://biospectrumindia.com/news/95/2281/one-of-the-much-awaited-launches-in-the-coming-days-is-aminis-platform.html Fri, 05 Oct 2012 13:16:00 +0530 Manish Mishrahead, bioscience division, Merck Millipore India Since the global merger of the two entities in 2010, Merck Millipore has been working towards integrating its businesses to aid the Indian consumer. With one of the largest sales forces in India, Merck Millipore India has slated 2011-12 as the year of restructuring and hopes to absorb all its existing resources, aiming for a double-digit growth. In an interview with BioSpectrum, Manish Mishra, head, bioscience division, Merck Millipore India, talks about what the merger means for its customers, their strengths, a slew of customer centric initiatives and his plans to tackle factors such as the depreciating rupee. Q How has the merger of Merck and Millipore resulted in you offering integrated solutions to Bioscience customers? Mishra: Merck is the world leader in chemicals and life science reagents catering to proteomics and genomics research. With Millipore, we have added innovative and high-end research instrument in cellular analysis and multiplexing, filtration and cell culture solutions to our portfolio. We have now expanded our product portfolio, widened our market presence and customer base under single brand, thereby providing â€œcomplete workflow solutions.â€? Q What is your strength in the bioscience industry? Our core values lies in innovation. This comes from our state-of-the-art research instruments in cellular analysis and multiplexing reagents. Our research tools, life science reagents and small molecules are of the best quality. Efficient field force with pan-India coverage and excellent service shapes a strong market environment for us. We believe in organic growth and develop our team through continuous training programs of our innovative and expansive product range. Q How would you describe your current operations in India? We have the largest field force in India in bioscience and a structured distribution network. This, in addition to our expansive portfolio, leverages us to have a wide customer base with deepest penetration. We ride on success stories coming not only form Tier I cities, but also from Tier II and III towns. Our R&D facilities are present worldwide. We are much focused on the development of in-house products and made sizeable investments at our R&D facility in Bangalore. A strong information exchange between the field force and R&D team keeps us ahead in terms of innovation and launch of new products in accordance to market trends. We are also in the process of establishing a centralized and state-of-art warehouse in Bangalore. Q How do you place yourself in the bioprocess market? We are market leaders and trend setters in filtration and sample preparation business in both academic and industrial segments worldwide. Flow cytometry is a growing business in India. Acquisition of Guava was instrumental to complete our product portfolio gap in cell analysis and research areas. We partnered with Luminex Corporation to extend our offering in the multiplexing instrumentation. Our portfolio in antibodies and life science reagents is also very extensive. Q How do you view the current competition in the supplier industry? India gives us a huge opportunity for growth. Market dynamics are complex; price, delivery time and quality sensitivity are high. Customers look out for value-added services and additional features. More global players are entering Indian research and industry sphere through strategic joint ventures and acquisitions that leads to price war and multiple quality product offerings. Q Do you feel the need for a stronger industry lobby for issues such as import policy and so on? Definitely yes. Due to exorbitant custom Duties and clearance charges, we end up paying high landing prices. This makes us lose the advantage against low-cost offerings. Market-friendly government policies on customs will definitely groom healthy competition in quality products, with the price advantage being passed on to the end-users. Q What are the new products launched in this year? This year we have launched Muse Cell Analyzer, a miniatured table top version of Guava flow cytometer, a fourier transform-infrared (FT-IR) based protein quantification system â€œDirect Detectâ€? targeting proteomics labs, and Strat-M which is a unique product launched that mimics human skin and targets the cosmetic industries, skin bank and research institutes. There are continuous launches in the multiplexing and molecular biology applications. One of the much awaited launches in the coming days is Aminis platform. This couples the power of flow cytometry with microscopy. Q What are the challenges that you currently face? I feel that challenges are always a window for development. We have worked through various issues that emerged during the past. We are affected by rupee depreciation. We try to tackle the situation by bulk importing fast moving items and keep a check on logistics cost with micro details. We face issues at rate contracts as we don't have a say in the discounts over it. Manasi Vaidya ]]> <![CDATA[Indian biotech looking for the right support]]> https://biospectrumindia.com/news/95/1332/indian-biotech-looking-for-the-right-support.html https://biospectrumindia.com/news/95/1332/indian-biotech-looking-for-the-right-support.html Fri, 05 Oct 2012 13:03:00 +0530 SaysDr Satya Dashsenior strategy consultant to Indian Institute of Management Bangalore and Indian Institute of Science As the Indian economy grows, the demand for food, fuel and affordable healthcare will increase. On one hand this expansion in economy will continue to increase the size of the domestic market, and on the other hand, it will also allow the increase of many challenges that India and the world are currently facing, be it in affordable healthcare and medicine, food and fuel security or in keeping the environment clean and sustainable. Biotechnology will offer solutions to myriad challenges that India, as a transition economy, will face in the near future. The Indian biotechnology industry is at a point where given the right support it can become one of the leaders in bio-economy. The energy level of this industry in India is high, especially shown by innovative entrepreneurs and industry leaders. Immense opportunities lie in biosimilars, devices and diagnostics, stem cells, natural product-derived drugs, m-health, systems biology, industrial biotechnology including green chemicals and synthetic biology, as well as in agri-biotech especially integration of new technologies and methodologies in agricultural practices and expansion and deepening of contract research and manufacturing services. It is important to have stretch goals for this sector and this industry, which has been growing at an average of 20 percent over the last decade, has the potential to grow at 30 percent in the next decade if the right support is provided and it can reach a target (for biotech and healthcare) of $100 billion in revenues by 2025. This could become a reality given the talent India has in entrepreneurial dynamism. Challenges remain, no doubt. The present â€œregulatory regimeâ€? in India remains a huge hurdle especially due to the timelines taken for decisions and multiple windows that need to be navigated. This has a downward effect on investor confidence and risk behaviour. These regulatory hurdles have to be addressed immediately. A raft of regulations in emerging areas of stem cell, synthetic biology, medical diagnostics, genomic data including personalised genomic data need to be put in place at the earliest. Challenges also remain in the access to cutting-edge technologies, technology transfer, basic infrastructure for research, academia-industry linkages as well as infrastructural issues involving sourcing, distribution and logistics for biotech products. Many of these gaps have been ably bridged by the Government, especially the Department of Biotechnology (DBT) as well as Biotechnology Industry Research and Development Assistance Council (BIRAC). The Government through BIRAC and DBT has brought in significant schemes such as Biotechnology Industry Partnership Program (BIPP), Small Business Innovation Research Initiative (SBIRI) and Ignition Grant that have helped in de-risking early and middle stage steps in the bio-innovation process and these schemes have the potential to jump-start bio-entrepreneurship leading to the catalysis of India's bio-economy. The report generated by ABLE titled, â€œThe Indian Biotechnology, The Road Map to Next Decade and Beyond,â€? with the support from DBT and BIRAC, captures the trends in the biotechnology sector globally and touches upon the dynamism shown by the Indian biotechnology and healthcare entrepreneurs and leaders in providing innovative solutions. The process, initiated in 2011, involved a consultative engagement with an array of senior industry leaders and as well as entrepreneurs through the nodal industry body Association of Biotechnology Led Enterprises (ABLE) and its partnering organizations. The report provides several recommendations for India to be a global leader as a bio-economy, taking India to the leading front of innovation and capture the immense opportunities that are there to be seized. This requires partnership efforts among the stakeholders namely government, industry and academia.  About the author Dr Satya Dash is currently the senior strategy consultant to IIM-B and IISc. Previously, he was the chief operating officer of the nodal biotechnology industry organisation of India, ABLE. ]]> <![CDATA[Is your food genetically modified?? check the label]]> https://biospectrumindia.com/news/95/2818/is-your-food-genetically-modified-check-the-label.html https://biospectrumindia.com/news/95/2818/is-your-food-genetically-modified-check-the-label.html Fri, 05 Oct 2012 12:56:00 +0530 With effect from January 1, 2013, the government has made it mandatory to mention the sign, â€œgenetically modifiedâ€? (GM) on every food package that contains it. While rolling out the new regulation, Food and Consumer Affairs Minister, KV Thomas, informed the parliament that, there is only a decreased level of awareness about GM foods amongst people in the country; the reason being GM food, which is relatively a new technology, has not been widely experimented. This statement came on the heels of the parliamentary standing committee report on Agriculture, headed by Basudeb Acharya, which also recommended compulsory labeling of all GM products so as to ensure that the consumer is able to make an informed choice. With the moratorium on Bt Brinjal issued on February 9, 2010, which is still in force, India at present does not produce any GM food. At the same time, in non-foods category, the government has allowed commercial cultivation of only Bt cotton since 2002. The latest order therefore is expected to essentially affect food importers and the agri-biotech industry in the long run. For instance, Heinz tomato ketchup may need to display â€œGMâ€?, if the original ingredients included GM tomatoes. The same will be applicable in the case of imported oils like soyabean and canola. Even imported potato chips and tortillas will come under the scanner. Referring the move to be arbitrary in nature, Dr Shanthu Shantharam, professor, Iowa State University, Ames, Iowa and former executive director of Association of Biotech Led Enterprises-Agriculture Group (ABLE-AG) stated that, the labeling rule has been made hastily and without a proper discussion or consultation. He goes on to ask an interesting question, â€œWe all know that groundnut and cow's milk is allergic to certain sections of the population, but do they label them in the Indian market?â€? Dr B Mazumdar, vice president, Bejo Sheetal Seeds feels that at the moment it is very difficult to comment anything about the long term implications. â€œAt this present situation it does not make any difference because the fate on agri-biotech still remains undecided,â€? added Dr Mazumdar. Illegal imports Right to information (RTI) responses have revealed that no permission has been granted for the import and sale of any GM food in India other than purified soya oil. According to Food Safety and Standards Act, 1986, no person shall manufacture, distribute, sell or expose for sale or dispatch or deliver to any agent or broker for the purpose of sale, any packaged food products (including genetically modified or engineered food or food containing such ingredients) which are not marked and labelled in the manner as specified by the regulations. Genetic Engineering Appraisal Committee (GEAC), which currently regulates the GM food affairs wants some of its regulatory powers to be shared by the Food Safety and Standards Authority of India (FSSAI). But the Authority is still in a nascent stage and the general impression is that, its food lab in Kolkata under the Ministry of Health, is not so well-equipped. Dr Sagari R Ramdas, director, Anthra, while deposing before committee had stated that, â€œThere is no system of labeling in this country. So, we have absolutely no way of assessing if the cotton seed oil is either GM oil or non-GM oil.â€? Civil society activists allege that many Indians may already be eating the controversial corn through a variety of imported products made out of GM corn. The contention is based on the fact that chips made of corn are being imported regularly to India by American manufacturers via dealers in Singapore and Taiwan. They point out that, in 2008, an import consignment of Doritos, a chips brand owned by PepsiCo, was detained by Customs authorities in Mumbai, as it was allegedly found to contain genetically modified ingredients. Following this, the importer penned to the GEAC seeking a â€œno objection certificateâ€?. The GEAC cleared the consignment based on an undertaking given by the company that the chips did not contain GM corn. Greenpeace claims that tests conducted at an independent laboratory on products picked up randomly from a supermarket in the capital revealed Doritos corn chips to contain genetically modified Mon 863 and NK 603 variety corn ingredients. According to Shivani Shah, campaigner, Greenpeace, â€œThere has been no permission granted for the cultivation of GM food crops in the country. But the imported processed foods in all likelihood may contain varying amounts of GM ingredients. There is a Directorate General of Foreign Trade (DGFT) rule to ensure no unapproved GM food enters our markets through import, but unfortunately there is no mechanism to check this at our ports of entry.â€? However, PepsiCo spokesperson had claimed that the chips were produced in Taiwan from locally grown corn suppliers and denied the official import of these chips into the country. Two Delhi-based importers on condition of anonymity told BioSpectrum that they were unaware of the GM issues and mentioned that they have been importing the Doritos chips and Heinz ketchup on regular basis. â€œThe labeling might make consumers skeptical about the products and even might affect the other non GM foods too,â€? said another importer. Will regulation really work? Many feel that the current regulation is weak and leaves room for misuse by the food industry. Given that there is no mention of the threshold levels, traceability and liability which are necessary corollaries of a labeling system for GMOs, it is also said that the notification needs to be fleshed out further to ensure that the directed intention meets desired objective. Citing labeling as a very contentious issue, Dr Shantharam opined, â€œIt is believed by the industry that it is like posting 'skull and crossed bones' on GM foods as it has been demonized by the anti-GM lobby. It is a trick to castigate the GM food and kill the market for it. Moreover, what counts in is the â€œtruth in labelingâ€?. With the kind of supply chain that operates in India and other developing countries, it is very difficult to maintain a strict segregation from farm to fork. Therefore, whatever is served at the dining table may not be what it says on the label, thereby misleading the consumer.â€? But at the same time, the parliamentary committee report seeks to dispel notions that it might not work in India. It specifically mentions China, which despite being a populous country made labeling of such products mandatory. â€œThe new regulation needs to make it clear that this will not only be applicable to processed foods from within India, but also foods that are imported as well. Labeling also needs to be applicable to oil, which comes from Bt cotton seeds in India as well as soya and corn oil which is imported to the country from countries like the US,â€? said Basudeb Acharya, chairman, Parliamentary Committee on Agriculture. Rajesh Krishnan, campaigner, Greenpeace India, is strongly of the opinion that government must enact a legislation to protect the rights of consumers. â€œToday, consumers have no rights and no means to know which imported food contains GM. There should be compulsory testing and labeling of GM foods entering the country,â€? enthused Krishnan. With Ferderal Drug Investments (FDI) in retail being seen as a boost for importers, it remains to be seen how effective the new law would be in its checks and balances. Moreover, ensuring that the intended message has reached the consumer will alone not suffice, but the awareness about the GM foods cleared by the overseas regulatory agencies declaring it safe, should also be considered crucial. Rahul Koul ]]> <![CDATA[Side effects of the New Drug-Pricing Policy]]> https://biospectrumindia.com/news/95/1123/side-effects-of-the-new-drug-pricing-policy.html https://biospectrumindia.com/news/95/1123/side-effects-of-the-new-drug-pricing-policy.html Fri, 05 Oct 2012 12:46:00 +0530 As the Government gets closer to ink the new drug-pricing policy, BioSpectrum seeks industry's reactions to the September 27 announcement by the Group of Ministers A Group of Ministers (GoM ), on September 27, headed by Union Agriculture Minister Sharad Pawar, has finalized a new drug-pricing policy for essential medicines. The Department of Pharmaceuticals in 2011 had prepared a list of 348 medicines and also included most of the basic vaccines as essential medicines. The essential medicines will come under the purview of the government price control after the policy gets the cabinet committee's nod and the prices of all essential medicines will be fixed as the weighted average price of all brands of the same medication having more than one percent market share. The National Pharmaceutical Pricing Authority was monitoring 74 bulk drugs and their formulations so far. The GoM headed by Pawar and consisting of Srikant Jena, Union Minister for Fertilizers and Chemicals; Ghulam Nabi Azad, Union Minister for Health; Kapil Sibal, Union Minister for Human Resources and Development, Communications and IT; Salman Khurshid, Union Minister for Law and Justice; and Montek Singh Ahluwalia, Deputy Chairman, Planning Commission arrived at a consensus to use weighted average prices for all the drugs, which had a market share of more than one percent. This policy initiative got mixed reactions from the industry, analysts, and associations. Tapan Ray, Director General, Organization of Pharmaceutical Producers of India (OPPI), said, â€œThe new proposal will have an adverse impact on the industry, as the price control will encompass a third of the Indian pharma industry and result in further squeeze of the margins.â€? Acknowledging the rights of the government to make essential medicines available to the most vulnerable sections of society at affordable prices, Ranjit Shahani, president, OPPI and vice-chairman and managing director, Novartis India, said, â€œThis initiative will have negative impact on the industry. A market-based policy is a balanced formula and will help improve the availability of essential medicines for patients.â€? On the contrary, Dr Ajay Kumar Sharma, associate director, Pharma and Biotech, Healthcare Practice, Frost & Sullivan, South Asia and Middle East observed, â€œThe policy comes as a relief for the industry. The use of weighted average prices for all the drugs, which have market share beyond one percent, is preferred by the GoM as compared to few other methods proposed. Specifically the current cost of production plus the mark up policy being pursued for the 74 bulk drugs under the National List of Essential Medicines (NLEM) comes as a big relief for the industry. The consumers are benefited because, the NLEM list has been increased from current 74 to 348 (approximately includes 750 formulations), which will reduce the prices for these drugs up to 20 percent. The grey area here is that the specific drugs for specific strengths are only included in the current NLEM list. Hence it would be interesting to see how the industry looks at by-passing this regulation. On an overall basis this can be seen as a win-win situation for all.â€? Sharing their perspectives on this subject Rahul Sharma and Nishith Sanghvi, Karvy Stock Brocking analysts said, â€œThe companies which are in the premium pricing band would be impacted the most. MNCs in particular, which have a pure domestic play like GSK Pharma and Sanofi India would be impacted the most, with contraction in EBDITA margins for the business as a whole. Indian companies not having very huge exposure to the domestic play would be insulated to some extent, but what we would be seeing is contraction in EDBITA margins for the domestic segment as a whole and hence impacting the profitability. The companies such as Dr Reddy's, Sun Pharma, Lupin, Ranbaxy Labs and Cipla would be less impacted due to their presence in the exports space.â€? As per the Karvy Stock Broking analysts a majority of the organizations, who were disappointed, expected the the Policy to take into account only the drugs, which had a market share in excess of 5 percent as the criteria. Including all drugs that have a market share of more that 1 percent would have a higher number of companies in the net. â€œThe initial assessment based on a 50 percent price cut and a possible 80 percent price cut for products show a higher impact on Sanofi Aventis, GSK Pharma, Cipla, Ranbaxy Labs, Cadila and Torrent Pharmaceuticals,â€? said Sharma. Sanghvi added, â€œWe believe that the policy would take a minimum of six months to implement as problems would crop up on the inventory in the system, as it would need inventory recall once the policy is implemented. There will also be issues of reprinting and repacking of the stocks. The other problems impacting the companies would be the implementation of the pricing on MRP regime, the price which both the AIOCD/IMS is capturing is based on the wholesale price to the retailer and it does not include the excise duty element, retailer margins and VAT.â€? It is likely that it would take another 6-12 months for the government to implement this policy after it is cleared by the cabinet committee and sent to the Supreme Court, as the matter is before the apex court for hearing as a petition was filed by All India Drug Action Network (AIDAN) for reducing the number of drugs under price control from the current 74 bulk drugs to about half. The apex court asked the government to regulate prices of essential drugs. Need for updating NLEM To address the issues of changing disease prevalence, treatment modalities, introduction of newer medicines and identification of unacceptable risk-benefit profile as well as therapeutic profile of some medicines, the Ministry of Health & Family Welfare (MOHFW) considered the need for updating the National List of Essential Medicines (NLEM). The first National List of Essential Medicines of India was prepared and released in 1996, which was subsequently revised in 2003. Narayan Kulkarni (inputs from Manasi Vaidya) ]]> <![CDATA[CRO hotspots]]> https://biospectrumindia.com/news/95/2175/cro-hotspots.html https://biospectrumindia.com/news/95/2175/cro-hotspots.html Thu, 06 Sep 2012 16:21:00 +0530 India confident to dominate 47% serve sponsors with a revenue range of more than $200 mn 30% focus on client expansion; 28% on revenue growth as key priorities 76% confident about increasing opportunities over next three years Most enterprises operating in India are small and medium-sized Average contract size for CROs in India is under $50 million Top therapeutic focus areas are oncology, cardiovascular diseases, CNS, respiratory diseases and dermatology India, China, South Korea are hotspots for patient recruitment and trials Indian CROs are concentrated on contract and clinical research Quality, reliability, regulatory compliance, pricing, productivity and accessibility are key performance metrics With an obective to capture the key trends of the pharmceutical CROs in the region, BioSpectrum, in association with CyberMedia Research (CMR), a premiere market research firm that specializes in competitive intelligence, advisory and consulting for life sciences and healthcare, primarily in the APAC region, conducted a survey to identify the latest trends and issues facing the pharmaceutical contract and clinical research industry. Fourth Annual BioSpectrum - CMR Survey of the Contract and Clinical Research Organizations (CROs) 2012 This report by BioSpectrum and CMR is based on a survey of 18 senior CRO executives from India. All the respondents were from the C-level, or above, and based in India. Respondents came from companies of all revenue sizes, with 93 percent representing CROs with less than $50 million in annual revenues, while seven percent from companies in excess of $500 million. The survey included a mix of quantitative and qualitative research, administered through email, and direct telephonic interviews with senior executives and experts in India. In addition, desk research was conducted to complement the survey findings. Indian CROs in the Asia-Pacific CRO Ecosystem Indian CROs are slowly expanding their geographical reach by focusing on multiple geographies to cater to their global clientele. According to 32 percent of the respondents of the Fourth BioSpectrum-CMR Annual Survey of the Clinical and Contract Research Organizations 2012, India is their key focus market wherein all their services are concentrated. Fourteen percent of the CROs have a presence in Malaysia, while 11 percent are focused on China. These are the top three countries of Asia-Pacific wherein Indian CROs are focused on providing their services. Interestingly, Australia, South Korea, Singapore, Japan, and Taiwan are also geographies wherein Indian CROs have expanded their reach. Asia-Pacific hotspots for clinical trials and patient recruitment Unlike the West, Asia-Pacific has been a fertile ground for patient recruitment, with the willingness to participate by patients being traditionally high. This can be traced to the large available patient population. In addition, the lifestyle and stress-related diseases such as diabetes and cardiovascular diseases are increasing rapidly among the Asian population, owing to increasing adaptation of sedentary lifestyle. When compared to the West, the number of available patients is also higher at each trial site as they are located at large hospitals. According to the survey respondents of the Fourth BioSpectrum-CMR Annual Survey of the Clinical and Contract Research Organizations 2012, China and South Korea (18 percent) and India (28 percent) with their vast population are the key countries wherein the willingness to participate in clinical trials is high. The willingness to participate is also high in countries such as Malaysia, Thailand and Singapore. A snapshot of Indian CROs According to the survey respondents of the Fourth BioSpectrum-CMR Annual Survey of the Clinical and Contract Research Organizations 2012, Indian CROs are engaged in both clinical and contract research. 45 percent of Indian CROs are focused on contract research, while 41 percent are engaged in clinical research. According to 14 percent of the Indian CRO survey respondents, they are engaged in biomanufacturing. Early trends indicate that India and China are seeing increase in contract manufacturing. Services offered by CROs The Fourth BioSpectrum-CMR Annual Survey of the Clinical and Contract Research Organizations 2012 reveals that CROs in India offer a wide array of services. According to 77 percent of the survey respondents, their services are concentrated around project management, clinical trial monitoring, quality assurance and medical writing. 72 percent of the CROs offer patient and investigator recruitment and site management, while 66 percent of the CROs provide trials, regulatory affairs and data management. 61 percent of the CROs provide biostatistics and medical scientific services. 55 percent, 50 percent, and 38 percent of the CROs offer drug safety, pharmacovigilance and bioanalytical laboratory services respectively. The concentration of clinical trials by phase According to the survey respondents of the Fourth BioSpectrum-CMR Annual Survey of the Clinical and Contract Research Organizations 2012, Indian CROs are focused across the preclinical, phase I to phase IV pathway. According to 22 percent of the respondents, phase II and phase III are where the clinical trials are most concentrated. Nineteen percent of the respondents cited that their clinical trials are mostly in the preclinical Phase while 17 percent indicated phase IV. 93 percent of CROs continue to operate within a revenue size of $50 million According to 93 percent of the survey respondents of the Fourth BioSpectrum-CMR Annual Survey of the Clinical and Contract Research Organizations 2012, they operate below the $50 million band. Seven percent of the companies indicated a revenue size greater than $500 million. Oncology is the hottest therapeutic area for Indian CROs Oncology is the top therapeutic focus area for Indian CROs, with 63 percent of the respondents of the Fourth BioSpectrum-CMR Annual Survey of the Clinical and Contract Research Organizations 2012 citing it. Indian CROs are focused on an array of therapeutic research areas including metabolic diseases, infectious diseases, pain management, hematology, anti infectives, rheumatology, inflammation, and ophthalmology. 21 percent of the CROs serve more than 50 clients every year According to the survey results of the Fourth BioSpectrum-CMR Annual Survey of the Clinical and Contract Research Organizations 2012, 21 percent of the Indian CROs serve more than 50 clients every year. Average contract size of Indian CROs As per the survey results of the Fourth BioSpectrum-CMR Annual Survey of the Clinical and Contract Research Organizations 2011, over 90 percent of the Indian CROs operating in the Asia-Pacific region have an average contract size of worth $1-5 mn with each customer. 47% of the sponsors are in $ 200 million revenue range According to 47 percent of the respondents of the Fourth BioSpectrum-CMR Annual Survey of the Clinical and Contract Research Organizations 2012, Indian CROs serve sponsors with a revenue range greater than $200 million. 15 percent of the survey respondents indicated that the revenue range of sponsors is less than $50 million, while another 23 percent serviced sponsors with a revenue range in the than $101-200 million bracket. Key performance metrics for Indian CROs Measuring and tracking performance related to study conduct at all stages of the clinical trial lifecycle has been given prime importance by CROs with the intentention to implement cohesive strategies for improved efficiency and quality in clinical trials. According to the respondents of the Fourth BioSpectrum-CMR Annual Survey of the Clinical and Contract Research Organizations 2012, quality (18 percent) is the most important parameter for measuring their performance, followed by reliability (14 percent), regulatory compliance (14 percent), pricing (13 percent), productivity (12 percent) and accessibility (10 percent). Number of employees Indian CROs are small to mid-sized operations. According to 27 percent of the respondents to the Fourth BioSpectrum-CMR Annual Survey of the Clinical and Contract Research Organizations 2012, they employ around 251 to 500 personnel, while 16 percent indicated that they have 101 to 250 personnel. 22 percent of the respondents indicated that they have 51 to 100 personnel, engaged in various functions. Functional roles in a CRO The Fourth BioSpectrum-CMR Annual Survey of the Clinical and Contract Research Organizations 2012 reveals that 50 percent of the employees in an Indian CRO perform the role of Clinical research associates, seven percent of the workforce manage database management while 21 percent of the workforce comprises of the sales, management and administration. Most important priorities for Indian CROs Indian CROs are focused on revenues and client expansion as their key priorities, while looking to expand geographically. According to 30 percent of the respondents of the Fourth BioSpectrum-CMR Annual Survey of the Clinical and Contract Research Organizations 2012, client expansion is the most important priority for their enterprise. Revenue growth is the key priority for 28 percent of the survey respondents, while according to 21 percent of the survey respondents, geographical expansion is the most important priority. These trends are in line with the trends captured in the previous BioSpectrum-CMR surveys. According to 21 percent of the Indian CROs surveyed in the BioSpectrum-CMR Asia-Pacific Annual Survey of the Clinical and Contract Research Organizations Survey 2012, product development is the most important priority for them. According to the Indian CROs, the rich experience and expertise of the CROs in India, the increasing research and development investment by biopharma in strategic collaborations, and cost pressures encouraging R&D outsourcing are some of the factors influencing their optimism in increasing market opportunities. ]]> <![CDATA[Biotechnology: call for action]]> https://biospectrumindia.com/news/95/1203/biotechnology-call-for-action.html https://biospectrumindia.com/news/95/1203/biotechnology-call-for-action.html Thu, 06 Sep 2012 15:53:00 +0530 By Ajit Mahadevan, partner - life sciences, Ernst & Young, India The biotechnology industry in India is at a critical juncture. While the industry has been growing at a double-digit rate over the last five years (CAGR 19.2 percent, 2007-2011), it has concurrently been facing diverse challenges that have prevented the industry from transcending to the next level. The biopharmaceutical industry constitutes 60 percent of the biotech industry in India. Even within the domestic market, companies have not been able to launch new products at a pace that they would have liked. Dealing with multiple regulatory bodies typically results in serious delays in getting approvals, which in turn leads to tremendous strain on the resources of biopharma companies. To overcome this, the government of India proposed to set up the Biotechnology Regulatory Authority of India (BRAI) through an act of the parliament. However, with opposition from several state governments, there is no clarity on how long it will take to get this cleared in the parliament. Companies focused on innovation have not been able to make a sizeable impact on the industry either. Many of them are facing funding constraints as the investor community has shied away from investing in early stage ventures. The government, on its part, has introduced several schemes. As an incentive for in house research and development, the government also provides 200 percent weighted tax deduction, which has been extended till 2017 in this year's budget. However, given the large development timelines, cost and risk of biotech research, these funds and incentives are not enough to drive innovative biotech research in the country. While India has a substantial number of graduates in biotechnology and related fields, they are not optimally trained to cater to industry demand. Companies therefore have to significantly invest in their training and development before they become ready to contribute to the business. In terms of infrastructure, several biotech parks have been set up in India in the last five years with public private partnerships. The industry, however, believes that most of biotech parks are more congenial to biotech services and diagnostics firms rather than to pure-play biotech manufacturing companies. To support bio-manufacturing activities, the government should evaluate the feasibility of making available land at subsidized rates, uninterrupted power at competitive prices, good quality water supply and effluent treatment facilities to improve the efficiency and productivity of pharmaceutical companies. India is already facing stiff competition from China, Korea, Singapore, and more recently Malaysia, in terms of attracting investments from MNCs. This has been enabled due to better technological and scientific competence, better infrastructure, tax and duty exemptions, and easier regulatory procedures as compared to India. Thus, there is strong call for action for the government to act swiftly to carry out regulatory reforms, to develop infrastructure and to provide more incentives to the biotech industry to remain competitive and spur growth in the industry. The industry, on its part, needs to come up with a concerted action plan to utilize the available infrastructure and resources more efficiently and focus on nurturing innovation to take the biotech industry to new heights.  About the author Since April, 2008 Ajit Mahadevan has been leading the life sciences consulting group at Ernst & Young, India, on strategic and operations consulting engagements with Indian and multinational pharma and healthcare companies. ]]> <![CDATA[Plant biotechnology is critical to future of farming]]> https://biospectrumindia.com/news/95/1040/plant-biotechnology-is-critical-to-future-of-farming.html https://biospectrumindia.com/news/95/1040/plant-biotechnology-is-critical-to-future-of-farming.html Thu, 06 Sep 2012 15:51:00 +0530 By Dr Ravi Khetarpal, regional director, south Asia, Centre for Agricultural Bioscience International (CABI), UK Plant biotechnology is successfully impacting the world by helping farmers grow more crops on less land with fewer natural resources. The fact that biotech crops are increasingly being adopted in many countries is a testament to its success. Biotech food crops have been cultivated for more than 16 years and safely consumed by billions of people worldwide. Biotech crops help farmers protect land for future generations by enabling sustainable agricultural practices. In fact, between 1996 and 2009, global farm incomes have increased by nearly $65 billion due to enhanced productivity and efficiency gains from biotech crops. In India, Bt cotton, the nation's only commercially approved biotech crop, to date has helped farmers earn an additional $9.4 billion between 2002-10 through a significant reduction in pesticide applications and yield increase. Biotech crops have helped preserve forests and other wildlife habitats by allowing farmers to increase productivity from available cultivable land. Biotech crops have also helped prevent soil erosion, restore soil quality and reduce greenhouse gas emissions from farm equipment used for ploughing and applying pesticides. Biotech crops can also help in keeping carbon in the soil. In 2010, biotech crops saved carbon dioxide emissions equivalent to removing nine million cars from the road for one year. Today, agriculture accounts for about 70 percent of global water use-with dwindling resources, it will be imperative for agriculture to become more water-efficient. Techniques and new plant varieties that utilize low-fertility soil and grow under drought conditions will be crucial. As the global population continues to grow, making the most of existing farmland and bringing any new available land under cultivation will be critical. Poor nutrition accounts for nearly 50 percent of deaths in children under the age of five in India. Investing in research and development to produce nutrient-enhanced crops through biofortification can help increase food quality and security for the masses. With plant biotechnology, researchers have been able to enhance the nutrient content in various crops. Sustainable agriculture is the need of the hour. It has been defined as â€œan integrated system of plant and animal production practices having a site-specific application that will last over the long-term to: Satisfy human food and needs; Enhance environmental quality and the natural resource base upon which the agricultural economy depends; Make the most efficient use of non-renewable resources and on-farm resources and integrate, where appropriate, natural biological cycles and controls; Sustain the economic viability of farm operations; and Enhance the quality of life for farmers and society as a whole.â€? Plant biotechnology remains one the most promising tools to accomplish many of these goals. Yet, some countries have lagged behind in adopting this technology in spite of conventional approaches to farming reaching their limits. India with its rich think tank need not be one among them as it has the regulatory and technical capacity to largely address the biosafety issues.  About the author Dr Ravi Khetarpal is the regional director, south Asia (based at New Delhi) of the Centre for Agricultural Bioscience International (CABI), Oxfordshire, UK. ]]> <![CDATA[Quality date palm and red sanders]]> https://biospectrumindia.com/news/95/1207/quality-date-palm-and-red-sanders.html https://biospectrumindia.com/news/95/1207/quality-date-palm-and-red-sanders.html Thu, 06 Sep 2012 15:46:00 +0530 The project on development of commercial scale micropropagation technology for elite date palm and red sandalwood by Sun Agrigenetics was supported by DBT through its SBIRI scheme Date palm is a valuable tree that can be easily grown in the saline region, hence rendering the land very productive. Similarly, Red sanders is one of most expensive timber tree in the world as evidenced by the current international price of its timber which is as much as 1 crore per ton. However, the common issue faced by the farmers generally is the unavailability of quality planting material of both date palm and red sanders. In case of date palm, the traditional seed-derived propagules do not ensure the quality as well as desired female sex of plants that only bear the fruits resulting in wastage due to non-productive male plants that come from seeds. At the same time the dangerously diminishing population of sandalwood due to large scale illegal logging for smuggling into China, Korea, and Japan is also a matter of grave concern. Keeping in view the vast potential for planting tissue culture and the technology being not available for the identified elite varieties, Vadodara-based Sun Agrigenetics collaborated with Department of Biotechnology (DBT), and was granted funds under the Small Business Innovation Research Initiative (SBIRI) project to develop commercial scale technology for date palm and red sanders micropropagation. While the date palm project was initiated in August, 2010 with SBIRI funding worth 59 lakh, another project on red sanders was funded 31 lakh in April, 2011. The several accomplishments of the company can be credited to both the promoters of Sun Agrigenetics, Dr Daksha Bhatt and Dr Prashant Bhatt who were pioneers in commercial micropropagation having more than 20 years of experience in the field. The strong and focused objectives of the team has made the unit a recognized in-house R&D centre by Department of Scientific and Industrial Research (DSIR) as well as a recognition under National Certification System for Tissue Culture Raised Plants (NCS-TCP) from DBT. â€œThe research work on micropropagation involves extensive travel for collection of plant tissues, expensive chemicals and equipment as well as involvement of trained scientists. Protocol development is difficult and time consuming for tissue culture of such recalcitrant species with low success rates. Expenditure for all this is difficult to manage by a small company. We could only do this with the generous funding from DBT, partly as term loan and partly as grant-in-aidâ€? explained Dr Daksha Bhatt, director, technical, Sun Agrigenetics. Way forward There is a need to genetically map the unique trees to protect the valuable germplasm. The company has set up a facility for developing molecular marker for identification of such unique trees. The company believes that this technique could also be applied for other high value plants. The company's R&D team has identified some unique high yielding varieties of date palm which are old trees and there is no means of propagating them conventionally, so micropropagation is the only resort. Similarly, it has been able to trace some old trees of red sanders in the forests of central India which have unique wood quality and would be of interest to propagate such clones. Since India has very large acreage of as much as 23 million hectare of saline land which is non-productive, these projects which are of great relevance seem to be going just in the right direction. Rahul Koul ]]> <![CDATA[Virus resistant cassava plants]]> https://biospectrumindia.com/news/95/2057/virus-resistant-cassava-plants.html https://biospectrumindia.com/news/95/2057/virus-resistant-cassava-plants.html Thu, 06 Sep 2012 15:45:00 +0530 The joint project to produce virus-free transgenic cassava by the trio Rasi Seeds, Tamil Nadu Agricultural University and Madurai Kamaraj University found support from SBIRI scheme of DBT The granular preparation of cassava starch known as 'sabudana' is very popular in India. By virtue of its diversified uses, cassava has become an important commercial crop in the agricultural economy of states such as Kerala, Tamil Nadu and Andhra Pradesh. As per various reports, it is cultivated in India in an area of 0.2 million hectare producing 5.5 million of tuberous roots. This drought-tolerant crop is an attractive nutrition source, as the value-added products such as starch, sago, chips, flour from chips, thippi, peel, and sago wafers are produced from it. However, the presence of Indian mosaic virus has been a great concern for the farmers cultivating it. Hence, a joint project on transgenic cassava production with genes conferring resistance to Indian cassava mosaic virus (ICMV) disease was initiated by Rasi Seeds based in Salem district of Tamil Nadu along with Tamil Nadu Agricultural University (TNAU) and Madurai Kamaraj University (MKU), Madurai. The basic aim was to standardize methodology for regeneration of Cassava plants in tissue culture and study the incorporation and level of expression of transgene(s) in putative cassava transgenic events. The project initiated on March, 2008, received funding amount worth 68.53 lakh from Small Business Innovation Research Initiative (SBIRI) scheme of Department of Biotechnology (DBT). Among the three partners, TNAU has done sequence analysis of the virus strains of ICMV and Sri Lankan cassava mosaic virus (SLCMV) and made gene constructs using RNAi system. While MKU has made virus resistance gene construct using antisense technology for SLCMV, those constructs were used in Rasi Seeds lab for genetic transformation of Cassava for conferring resistance to cassava mosaic disease. At present several putative transgenic Cassava plants have been produced to protect against ICMV and SLCMV using viral resistant gene(s). These transgenic cassava plants are maintained in polyhouse conditions. The project was completed in September, 2011 and is now moving towards the phase II. â€œIt has been a very good opportunity to work with TNAU which made significant contribution and provided technical knowledge for the project. Also it was a good opportunity for us to interact with Dr K Veluthambi, professor, MKU on guidance in running the project,â€? said Dr Saravanakumar, principal scientist, biotech, Rasi Seeds, expressing his gratitude to the partners in the project. Way forward The project still holds tremendous relevance, with the stability of virus resistance yet to be tested in transgenic plants and the project in its developmental phase II. The virus resistance transgenic cassava plants have to be tested for tuber yield and starch content in confined field trials through phase II multiplication and the testing of transgenic cassava plants will be done during the phase. Due to mixed infection of ICMV and SLCMV, it is also desirable to develop lines with fusion gene with conserved region of the two viruses. The freedom from these two viruses can certainly increase the production of cassava, which in turn will boost the economy of southern states and also benefit the poor farmers who own marginal lands. Rahul Koul ]]> <![CDATA[Agri-biotech]]> https://biospectrumindia.com/news/95/2380/agri-biotech.html https://biospectrumindia.com/news/95/2380/agri-biotech.html Thu, 06 Sep 2012 15:44:00 +0530 PPP stimulates innovation in crop technology Rasi Seeds, Tamil Nadu Agricultural University and Madurai Kamaraj University have directed their coordinated efforts in developing virus-resistance Cassava plants. The project is supported through SBIRI scheme of Department of Biotechnology (DBT). Under the SBIRI scheme, Sun Agrigenetics has collaborated with DBT to develop quality Date palm and Sandalwood by using the micropropagation technology. The funding support from DBT under SBIRI, enabled Bangalore-based Indo-American Hybrid seeds to initiate the project on market assisted selection for development of salt-tolerant rice hybrids. ]]> <![CDATA['On an acquisition spree']]> https://biospectrumindia.com/news/95/1320/on-an-acquisition-spree.html https://biospectrumindia.com/news/95/1320/on-an-acquisition-spree.html Thu, 06 Sep 2012 15:33:00 +0530 Bruno BÃ¼rkel head, molded glass division, Gerresheimer Gerresheimer is a manufacturer of high-quality specialty products made of glass and plastic for the global pharma and healthcare industry. The company has a presence in 47 locations across Europe, North and South America and Asia. In April this year, it acquired majority stake in Neutral Glass, the Mumbai-based manufacturer of pharmaceutical primary packaging of glass. It has a modern molded glass plant in Kosamba, Gujarat in India. Gerresheimer is on a spree to further expand across the BRIC nations with five plants in South America and seven in China. In an interview with BioSpectrum, Bruno Buerkel, head, molded glass division, Gerresheimer, talks about company's recent acquisition and plans to move ahead in the Asia Pacific region. Q Tell us about the agreement with Neutral Glass. BÃ¼rkel: We have reached an agreement with Neutral Glass' former owners to acquire a majority shareholding in the company. The former owner family has retained a 30 percent stake and we have acquired 70 percent stake in the company. This is a strategically significant acquisition for us. Q Why did you go for this acquisition in India? The Indian pharma market is gaining international significance and it is growing at an impressive rate. Our acquisition of a majority shareholding in Neutral Glass will help us to strengthen our position in the emerging markets and to drive our growth in India. We opened the door to the Indian market by a small crack when we set up our sales and service office in Mumbai in 2010. Now, our new Indian subsidiary with local production operations in this growth market opens it wide. India's 1.2 billion population and its fast-growing economy makes it one of the most interesting markets in the world. The Indian pharma market is expected to achieve annual growth rates of between 14 and 17 percent until 2015. Requirements of medications are also rocketing in India. The country's healthcare system is improving with time. Increasing prosperity is driving up demand. As a result of these developments, both Indian and global pharmaceuticals companies are manufacturing more and more of their products in India. And we have to ensure that we are present in our customers' markets. Q Tell us about the company's other ventures, especially in the Asia Pacific. Expanding our business in emerging markets is a core element of our growth strategy. Our business strategy for the emerging markets is to closely track and profit from growth market trends. We are expecting demand for pharmaceuticals to increase. One area in which expenditure will increase significantly over the next five years is generic drugs. Therefore, the focus will be on high quality primary packaging. As a supplier of high quality, primary packaging products made of glass and plastic, we are present where our customers are. This local presence is absolutely essential if we want to fully exploit the market potential and achieve profitable growth in these markets. We already have a strong position at many places around the globe-from Mumbai and Moscow to Peking and Sao Paolo. Further investments, into organic growth or by means of acquisition of companies, are part of our strategy. Our acquisition of the Brazilian company Vedat in 2011 has enabled us to strengthen our position in the South American market for plastic primary packaging products. Vedat is the leading manufacturer of plastic closures. In conjunction with our existing plastic packaging production plants, we are now able to operate as a full-service partner to our South American customers. We currently have a total of four plastic packaging production plants in Brazil and Argentina. We have also been operating a medical plastic system plant in the metro area of Sao Paolo since 2010, where we predominantly manufacture components for the insulin pen systems used by diabetics. Close to our customers, we produce exactly the solution which is needed for the safe and precise administration of insulin. Q You have a strong presence in the BRIC nations. Which among these countries has the biggest market for you? The BRIC countries are all characterized by high growth rates plus record foreign trade figures, investments and increasing employment rates. The future outlook is pretty impressive: Expenditure on pharmaceutical products in the emerging markets is expected to almost double by 2015. By this time, they will then have a larger market volume than the top eight established industrial nations together (USA , Canada, Japan and the five leading European markets). A total of 3 billion people live in the BRIC countries, which is approximately 40 percent of the world population. With a greater number of people having access to a healthcare system, the potential number of patients increases and so does the demand for medical services and pharmaceuticals. China has the fastest growing pharmaceutical sector and market. However, there are also major growth forces at work in Brazil and a new economic age has dawned in India. In fact, India has one of the most rapidly expanding economies in the world. Vipul Murarka ]]> <![CDATA[Educator's successful research avatar]]> https://biospectrumindia.com/news/95/1059/educators-successful-research-avatar.html https://biospectrumindia.com/news/95/1059/educators-successful-research-avatar.html Thu, 06 Sep 2012 15:31:00 +0530 Biochem Research Dr Dhinakar Kompala CSO, Richcore Lifesciences Actually he was looking for a course that would give him a â€œsureshot Aâ€? when he took up biochemical engineering at Purdue University. â€œMy interest in biotechnology was thus developed by accident. Since then, I pursued only biochemical engineering because traditional chemical engineering suddenly became very boring!â€? That is how Dr Dhinakar Kompala, CSO at Richcore Lifesciences, describes the start of his 27-year-long career in biochemical and bioprocess engineering. Dr Kompala frequently shuttles between USA, where he has been teaching at the University of Colorado, and India every three months. While on a brief sabbatical in India five years ago, Dr Kompala decided to take up the offer of Subramani, CEO, Richcore Lifesciences, to help make Richcore a modern biotechnology company. Dr Kompala then helped set up the research and development facilities and the production plant at Richcore' s campus in Bangalore. Finding the right talent to lead the team was always a challenge, Dr Kompala adds. However, he believes that no challenge is insurmountable, as the team's efforts has now come close to fruition, with the near commencement of the manufacturing of their first enzyme, recombinant trypsin, which is an important enzyme with a variety of uses, including one in the production of insulin. One of the proudest moments in his career was when he developed an apparatus, called an inclined settler, used in large-scale perfusion bioreactors. He explains the principle behind its functioning when he says, â€œIf you put a filter inside the bioreactor to allow the liquid media to pass but not the cells, you can separate out the cells and have a continuous cell culture system. However dead cells would start to accumulate after a given time, which would then release proteolytic and glycolytic enzymes that can degrade secreted glycoprotein products. Dead cells are smaller in size as compared to live cells. If you send in a mixture of dead and live cells over an inclined flat surface, the difference in settling velocity of these two types of cells would be further enhanced as it is proportional to square of cell diameter. So the live and productive cells would settle down completely but the dead cells would not, allowing for their easy separation. By following this idea you could run a reactor continuously without having to stop it.â€? Dr Kompala published the results in 1990. This concept has been widely adopted by a number of biotech firms. Even though Dr Kompala did not patent this invention, it did allow him to obtain a number of research grants for his future projects. He was also awarded the NSF Presidential young investigator award in 1988 by the US government. In the future, Dr Kompala hopes to move towards working in biosimilars as well, along with helping establish a subsidiary in the US for the parent company. â€œI like to learn new things all the time. If a day goes by without me learning something new, maybe I am vacationing,â€? he concludes. Manasi Vaidya ]]> <![CDATA[Biosimilar policy needs further refinement]]> https://biospectrumindia.com/news/95/1432/biosimilar-policy-needs-further-refinement.html https://biospectrumindia.com/news/95/1432/biosimilar-policy-needs-further-refinement.html Thu, 06 Sep 2012 15:16:00 +0530 Though the Indian biotech industry welcomed the government's direction on 'Guidelines on Similar Biologics' announced at BIO Boston, USA in June, it raised concerns over the regulatory framework The Indian biotechnology industry, which has witnessed high growth in biosimilars in the last few years, welcomed the government's announcement of â€œGuidelines on Similar Biologics: Regulatory Requirements for Marketing Authorization in India,â€? but felt that more has to be done to streamline the existing regulatory framework for biologics and vaccines. Currently, there are 20 recombinant therapeutics approved for marketing in India by the Genetic Engineering Approval Committee (GEAC), the apex body constituted under the Ministry of Environment and Forests. Since 2005, the Review Committee on Genetic Manipulation (RCGM) under GEAC has approved 91 clinical trials to be conducted in India related to recombinant pharmaceutical and therapeutic products recommended by the Drug Controller General of India (DCGI). There are several biopharmaceutical companies actively involved in research and development, manufacturing and marketing of biologics in India. India witnessed a sharp rise in the number of branded biosimilars available in the country within a span of six years. Around 14 therapeutic drugs having 50 brands were available in 2005. This number has increased to 20 therapeutic drugs having 250 brands by 2011. There are 10 companies offering around 40 brands of insulin range of products. The other leading therapeutic products having a good number of brands include Erthropoietin with 55 brands, Chorionic Gonadotropin - 48 brands, Streptokinase - 33 brands, while Interferon and heparins have 10 brands each. The growing biosimilars market offers huge potential for companies involved in research and development and manufacturing. Along with the opportunities, this market also has challenges such as high cost to develop a simple biomolecule and time duration. To support the industry, the Department of Biotechnology (DBT), Ministry of Science and Technology in association with Central Drugs Standard Control Organization (CDSCO), Ministry of Health and Family Welfare, government of India set up a 20 member committee comprising of industry experts, scientists and government officials to draft a guideline on biosimilars. The committee headed by Dr G N Singh, drugs controller general (lndia) and Dr V P Kamboj, chairman, RCGM and ex-director, Central Drug Research of Institute as chairpersons submitted the draft guideline to the government in March for final consultations. The revised guidelines were announced in June by Dr M K Bhan, secretary, DBT at BIO, USA. â€œThe Guidelines on Similar Biologics released by the Government of India will provide a tremendous boost to Indian biopharmaceutical players. With a potentially huge domestic market and the growing global opportunity, India is poised to become a major player in biosimilars,â€? said William Lee, head of regulatory strategy, Quintiles Asia. The brighter side: These guidelines have been able to dispel the ambiguity as seen in the draft guidelines over a range of issues Aspects Before guidelines Present scenario as per guidelines Cell Banking No clear ground rules for establishment of cell banking, establishment and characterization Section 6.3: Direct reference to the ICH guidelines having clear specifications for this aspect. Fermentation process development As per Form C3, five batches of reproducible fermentation data is required for seeking pre-clinical approval from RCGM Section 6.2.2 reduces the requirement to â€œat least three batches of reproducible fermentation data.â€? Preclinical studies Lack of clarity on whether the drug substance, the drug product, or both of need to be tested pre-clinically. Guideline clearly recommends that the preclinical studies should be conducted with the final formulation of the similar biologic. Toxicological studies Schedule Y did not have any clear specifications for the pre-clinical studies of biosimilars Section 7.2.2 gives an explicit blueprint for design of toxicological studies in case of biosimilars. The nebulous part: These guidelines still seem to have left some questions unanswered Aspects Specifications as per guidelines Limitations Analytical methods Section 6.3.1: â€œExtensive State of the art analytical methods should be applied so as to detect even slight differences in all relevant quality attributes.â€? Difficult to execute unless the scope of the term â€œslight differencesâ€? is defined. Product characterization Section 6.3.2: â€œIn case where post-translational modifications are taking place, these modifications need to be identified and quantified.â€? Exact nature of post-translational modifications not defined. Absolute quantification of these modifications is not a practically viable approach. Confirmatory clinical studies Section 8.3: â€œ...the confirmatory clinical studies can be waived off if, structural and functional comparability of similar biologic and reference biologic can be characterized to a high degree of confidence by physicochemical and invitro techniques, among other pre-requisites.â€? Difficult to execute unless the scope of the term â€œhigh degree of confidenceâ€? is defined. Welcoming the government's initiative, KV Subramaniam, president and CEO, Reliance Life Sciences, who was a member of the drafting committee said, â€œThe Indian biosimilars guidelines are comprehensive in nature and address the pre-market and post-market regulatory requirements for biosimilars. The document clearly delineates the roles and responsibilities of authorities like DBT (RCGM) and DCGI in the approval process of a biosimilar. Accordingly, the RCGM oversees product quality, characterization, approval of protocols and review of preclinical toxicology studies while DCGI focuses on the approval and review of clinical trials and marketing authorization.â€? He further said, â€œThe guidelines state that all biosimilars should be compared to the reference or innovator product through all phases of development. There is clarity on the quality and quantity of data expected, for example, number of batches, bioassays, and analysis of products for post translational modifications. Animal studies have also been rationalized by allowing short term studies in relevant animal species. When such models are not available, it is recommended to follow Schedule Y of drugs and cosmetics act. Some redundant studies have been eliminated reflecting the current scientific understanding.â€? Dr Krishna Ella, chairman and managing director, Bharat Biotech International, hailed the government step by remarking that, â€œGuidelines will streamline the approval process and bring clarity to all biosimilar manufacturers. The new guidelines clarify several issues relating to product development and licensure. It is a highly welcome step in the right direction. Such guidance which documents several aspects of the regulatory process in India would be welcomed by industry. Guidelines laid out for clinical evaluation, pre-clinical evaluation, manufacturing process validations, and product characterization are widely accepted by the industry and these guidelines should be enforced strictly across the industry. We are happy that with introduction of this policy, there is going to be an adherence of International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guidelines (Q5A,Q5B, Q5D).â€? This comes as a welcome step in the wake of rapid growth of the Indian biosimilars market, which has grown by a whopping 200 percent in a relatively short span of time since 2008. â€œThese guidelines have come a long way from the abridged regulatory guidelines followed till now,â€? commented Dr Ashok Kumar, president, R&D, Ipca Laboratories. Issues faced by the industry â€œThe guidelines have taken into consideration the exceptions in the generally outlined product development pathway. For example the innovator product may have been developed in a particular host, but if the current expression systems are better in terms of quality of the product and yield, the guidelines have provisions for approval of products developed in a different host on a case-to-case basis. Similarly approval of new formulation of existing drug can be sought based on sound scientific data,â€? pointed out KV Subramaniam. However, some areas such as critical indications, or where very long-term end points are measured, it could have been further clarified leading to faster approval of the drugs. Dr Krishna Ella, however, raised concerns about some points in the draft by saying more has to be done to streamline the existing regulatory framework for biologics, vaccines and biosimilars. It is too complex due to the involvement of multiple departments from different ministries. The Indian biotech industry requires a single window regulatory authority that is strict and transparent. The current system has companies applying to multiple regulatory authorities under different ministries to obtain permissions for biologic material import, product development, preclinical testing, clinical trials, and marketing authorizations. A single window or single agency system is the norm in several countries with organizations such as the USFDA (USA), EMA (EU), ENVISA (Brazil), and SFDA (China), which operates as the central nodal agency. Dr Krishna's suggestion was to streamline the regulatory processes for CROs working for international clients on international products. Increased timelines for receipt of biologic test articles from foreign locations would reduce the competitiveness of the CRO industry. Dr Ella further recommended that Central Drugs Laboratory (CDL), Kolkata has to take responsibility for the availability of authorized reference standards and their identities, which currently is under ambiguity. CDL, Kolkata also could be developed along the lines of CDL, Kasauli, which receives batch samples for vaccines for testing and product release. Commenting on the challenges that the industry will face with the new regulations levied, William Lee of Quintiles Asia said, â€œThe Indian guidelines are not too dissimilar from the EU and WHO guidelines and the draft US guidelines. As these international guidelines are widely available and have been used for several years, most Indian biopharmaceutical companies are likely to be familiar with them. A major difference between the Indian guidelines and that of the international guidelines referred above is that there is no data exclusivity for first-approved products. This could lead to a situation where companies might get into patent related battles as there is lack of clarity in terms of data exclusivity.â€? â€œThe balance between the requirement of supporting data and time allotted for obtaining marketing authorization encapsulated in the guidelines enables to provide an environment conducive to companies to manufacture drugs at an affordable cost benefiting the larger patient population,â€? opined Subramaniam. â€œOverall, inspite of their limitations, these set of guidelines have come as a relief to the industry. The fact that the regulatory requirements are more or less at par with that of the international regulatory agencies (including ICH and USFDA), would make it much easier for the biopharmaceutical manufacturers of India to meet the international quality standards,â€? said Dr Ashok Kumar. â€œWe believe that the presence of a lucid framework would surely expedite the development of biosimilars in India that had been dawdling for want of a clear blueprint,â€? he added. Indian biosimilar players will now be able to compete on par with global biosimilar players. With this development, we may well see India leading the way in the development of biosimilars for the global market in the coming years. Also, more importantly, in providing a boost to biosimilar development, the government of India is creating a clear pathway for the development of cost effective and safe biologics for the people of India which fits in with the government's agenda of more affordable healthcare. â€œI do believe that the Indian guidelines are a step in the right direction and will evolve with more clarity in the next couple of years,â€? concludes Lee. ]]> <![CDATA[CRO hotspots India confident to dominate]]> https://biospectrumindia.com/news/95/1909/cro-hotspots-india-confident-to-dominate.html https://biospectrumindia.com/news/95/1909/cro-hotspots-india-confident-to-dominate.html Wed, 05 Sep 2012 18:04:00 +0530 47% serve sponsors with a revenue range of more than $200 mn 30% focus on client expansion; 28% on revenue growth as key priorities 76% confident about increasing opportunities over next three years Most enterprises operating in India are small and medium-sized Average contract size for CROs in India is under $50 million Top therapeutic focus areas are oncology, cardiovascular diseases, CNS, respiratory diseases and dermatology India, China, South Korea are hotspots for patient recruitment and trials Indian CROs are concentrated on contract and clinical research Quality, reliability, regulatory compliance, pricing, productivity and accessibility are key performance metrics Fourth Annual BioSpectrum - CMR Survey of the Contract and Clinical Research Organizations (CROs) 2012 This report by BioSpectrum and CMR is based on a survey of 18 senior CRO executives from India. All the respondents were from the C-level, or above, and based in India. Respondents came from companies of all revenue sizes, with 93 percent representing CROs with less than $50 million in annual revenues, while seven percent from companies in excess of $500 million. The survey included a mix of quantitative and qualitative research, administered through email, and direct telephonic interviews with senior executives and experts in India. In addition, desk research was conducted to complement the survey findings. Asia-Pacific hotspots for clinical trials and patient recruitment Unlike the West, Asia-Pacific has been a fertile ground for patient recruitment, with the willingness to participate by patients being traditionally high. This can be traced to the large available patient population. In addition, the lifestyle and stress-related diseases such as diabetes and cardiovascular diseases are increasing rapidly among the Asian population, owing to increasing adaptation of sedentary lifestyle. When compared to the West, the number of available patients is also higher at each trial site as they are located at large hospitals. According to the survey respondents of the Fourth BioSpectrum-CMR Annual Survey of the Clinical and Contract Research Organizations 2012, China and South Korea (18 percent) and India (28 percent) with their vast population are the key countries wherein the willingness to participate in clinical trials is high. The willingness to participate is also high in countries such as Malaysia, Thailand and Singapore. According to the survey respondents of the Fourth BioSpectrum-CMR Annual Survey of the Clinical and Contract Research Organizations 2012, Indian CROs are engaged in both clinical and contract research. 45 percent of Indian CROs are focused on contract research, while 41 percent are engaged in clinical research. According to 14 percent of the Indian CRO survey respondents, they are engaged in biomanufacturing. Early trends indicate that India and China are seeing increase in contract manufacturing. Services offered by CROs The Fourth BioSpectrum-CMR Annual Survey of the Clinical and Contract Research Organizations 2012 reveals that CROs in India offer a wide array of services. According to 77 percent of the survey respondents, their services are concentrated around project management, clinical trial monitoring, quality assurance and medical writing. 72 percent of the CROs offer patient and investigator recruitment and site management, while 66 percent of the CROs provide trials, regulatory affairs and data management. 61 percent of the CROs provide biostatistics and medical scientific services. 55 percent, 50 percent, and 38 percent of the CROs offer drug safety, pharmacovigilance and bioanalytical laboratory services respectively. The concentration of clinical trials by phase According to the survey respondents of the Fourth BioSpectrum-CMR Annual Survey of the Clinical and Contract Research Organizations 2012, Indian CROs are focused across the preclinical, phase I to phase IV pathway. According to 22 percent of the respondents, phase II and phase III are where the clinical trials are most concentrated. Nineteen percent of the respondents cited that their clinical trials are mostly in the preclinical Phase while 17 percent indicated phase IV. 93 percent of CROs continue to operate within a revenue size of $50 million According to 93 percent of the survey respondents of the Fourth BioSpectrum-CMR Annual Survey of the Clinical and Contract Research Organizations 2012, they operate below the $50 million band. Seven percent of the companies indicated a revenue size greater than $500 million. Oncology is the hottest therapeutic area for Indian CROs Oncology is the top therapeutic focus area for Indian CROs, with 63 percent of the respondents of the Fourth BioSpectrum-CMR Annual Survey of the Clinical and Contract Research Organizations 2012 citing it. Indian CROs are focused on an array of therapeutic research areas including metabolic diseases, infectious diseases, pain management, hematology, anti infectives, rheumatology, inflammation, and ophthalmology. Oncology is the hottest therapeutic area for Indian CROs Oncology is the top therapeutic focus area for Indian CROs, with 63 percent of the respondents of the Fourth BioSpectrum-CMR Annual Survey of the Clinical and Contract Research Organizations 2012 citing it. Indian CROs are focused on an array of therapeutic research areas including metabolic diseases, infectious diseases, pain management, hematology, anti infectives, rheumatology, inflammation, and ophthalmology. Average contract size of Indian CROs As per the survey results of the Fourth BioSpectrum-CMR Annual Survey of the Clinical and Contract Research Organizations 2011, over 90 percent of the Indian CROs operating in the Asia-Pacific region have an average contract size of worth $1-5 mn with each customer. 47% of the sponsors are in $ 200 million revenue range According to 47 percent of the respondents of the Fourth BioSpectrum-CMR Annual Survey of the Clinical and Contract Research Organizations 2012, Indian CROs serve sponsors with a revenue range greater than $200 million. 15 percent of the survey respondents indicated that the revenue range of sponsors is less than $50 million, while another 23 percent serviced sponsors with a revenue range in the than $101-200 million bracket. Key performance metrics for Indian CROs Measuring and tracking performance related to study conduct at all stages of the clinical trial lifecycle has been given prime importance by CROs with the intentention to implement cohesive strategies for improved efficiency and quality in clinical trials. According to the respondents of the Fourth BioSpectrum-CMR Annual Survey of the Clinical and Contract Research Organizations 2012, quality (18 percent) is the most important parameter for measuring their performance, followed by reliability (14 percent), regulatory compliance (14 percent), pricing (13 percent), productivity (12 percent) and accessibility (10 percent). Number of employees Indian CROs are small to mid-sized operations. According to 27 percent of the respondents to the Fourth BioSpectrum-CMR Annual Survey of the Clinical and Contract Research Organizations 2012, they employ around 251 to 500 personnel, while 16 percent indicated that they have 101 to 250 personnel. 22 percent of the respondents indicated that they have 51 to 100 personnel, engaged in various functions. Functional roles in a CRO The Fourth BioSpectrum-CMR Annual Survey of the Clinical and Contract Research Organizations 2012 reveals that 50 percent of the employees in an Indian CRO perform the role of Clinical research associates, seven percent of the workforce manage database management while 21 percent of the workforce comprises of the sales, management and administration. Most important priorities for Indian CROs Indian CROs are focused on revenues and client expansion as their key priorities, while looking to expand geographically. According to 30 percent of the respondents of the Fourth BioSpectrum-CMR Annual Survey of the Clinical and Contract Research Organizations 2012, client expansion is the most important priority for their enterprise. Revenue growth is the key priority for 28 percent of the survey respondents, while according to 21 percent of the survey respondents, geographical expansion is the most important priority. These trends are in line with the trends captured in the previous BioSpectrum-CMR surveys. According to 21 percent of the Indian CROs surveyed in the BioSpectrum-CMR Asia-Pacific Annual Survey of the Clinical and Contract Research Organizations Survey 2012, product development is the most important priority for them. According to the Indian CROs, the rich experience and expertise of the CROs in India, the increasing research and development investment by biopharma in strategic collaborations, and cost pressures encouraging R&D outsourcing are some of the factors influencing their optimism in increasing market opportunities. ]]> <![CDATA[Agri-biotech PPP stimulates innovation in crop technology]]> https://biospectrumindia.com/news/95/2543/agri-biotech-ppp-stimulates-innovation-in-crop-technology.html https://biospectrumindia.com/news/95/2543/agri-biotech-ppp-stimulates-innovation-in-crop-technology.html Wed, 05 Sep 2012 17:20:00 +0530 Rasi Seeds, Tamil Nadu Agricultural University and Madurai Kamaraj University have directed their coordinated efforts in developing virus-resistance Cassava plants. The project is supported through SBIRI scheme of Department of Biotechnology (DBT). Under the SBIRI scheme, Sun Agrigenetics has collaborated with DBT to develop quality Date palm and Sandalwood by using the micropropagation technology. The funding support from DBT under SBIRI, enabled Bangalore-based Indo-American Hybrid seeds to initiate the project on market assisted selection for development of salt-tolerant rice hybrids. ]]> <![CDATA[Unraveling the mystery of genomes!]]> https://biospectrumindia.com/news/95/1703/unraveling-the-mystery-of-genomes.html https://biospectrumindia.com/news/95/1703/unraveling-the-mystery-of-genomes.html Wed, 05 Sep 2012 15:28:00 +0530 BioAgri Dr Akhilesh Kumar Tyagi director, National Institute of Plant Genome Research (NIPGR), New Delhi Dr Akhilesh Tyagi is well known for his efforts in sequencing genomes of important crops. As a part of the international group involving 10 nations working on rice genome, Dr Tyagi led India's first foray into wide plant genome sequencing in India. The group completed its task much ahead of time and the work was subsequently published in Nature. He is also leading the ongoing efforts being made in sequencing of tomato and chickpea genomes. Dr Tyagi completed his PhD in Botany in 1983 from the University of Delhi in the area of cell genetics. This in his words laid a strong foundation to take up the challenge of research in the area of gene biology when he worked as a post-doctoral fellow in Germany (1984-86). Later he joined University of Delhi and helped establish Centre for Plant Molecular Biology (CPMB) and served as its coordinator from 1996-2009. Subsequently, he served as director of Interdisciplinary Centre for Plant Genomics (ICPG) between 2005-2009. The turning point came when Dr Tyagi joined NIPGR as its head in 2009 and continues to lead the institute. Besides having over 150 publications to his credit and mentoring about 25 PhD and postdoctoral students, Dr Tyagi has also served on editorial boards of leading journals such as Journal of Plant Biochemistry and Biotechnology, Proceedings of the Indian National Science Academy, and Transgenic Research, among others. He has been recipient of numerous awards and honors which include the National Bioscience Award by DBT (1999), BP Pal Memorial Lecture Award by NASI (2005), and Birbal Sahni Medal by Indian Botanical Society (2006), to name a few. Dr Tyagi has chaired many notable positions during his vast expanding career. He was elected as fellow of the Indian Academy of Sciences, Bangalore; National Academy of Sciences, Allahabad; and National Academy of Agricultural Sciences, New Delhi. He also served as vice president of Society for Plant Biochemistry and Biotechnology, and as general secretary, National Academy of Sciences. Dr Tyagi credits his contributions in research to his colleagues and research students. Currently the work on rice genomics at NIPGR has reached an exciting stage with emphasis on developing rice capable of tolerating water-deficit and improved high-yielding rice variety. The researchers at the institute led by Dr Tyagi, have made major contributions on the transcriptome and genomics of chickpea. More recently, the institute has contributed to the sequencing of tomato genome which was published in Nature. Now the on-going research is to sequence the chickpea genome. These projects have extensive collaboration with leading institutions and industry in India. â€œWe have to create such mechanisms that allow continuous contribution of basic science researchers during the phase of translation and product development. There is a need for more success stories, even if they are in select and not wide-spread areas, because success is likely to breed more success,â€? concludes Dr Tyagi. Rahul Koul ]]> <![CDATA[Double blow to GM crops]]> https://biospectrumindia.com/news/95/1506/double-blow-to-gm-crops.html https://biospectrumindia.com/news/95/1506/double-blow-to-gm-crops.html Wed, 05 Sep 2012 15:01:00 +0530 August 9, 2012 proved to be a day of setback for the GM crops in India with two potentially game changing developments concerning GM technology being announced. The first and the one with a larger impact, affecting transgenic crop research immensely, was the recommendation of a parliamentary standing committee to ban all GM crop trials in the country. The other was the radical move taken by the Maharashtra government to ban the sale of Mahyco's brand of Bt cotton seeds for its alleged involvement in black marketeering of seeds. BioSpectrum takes a look at both of these events and the potential impact it will have on the burgeoning agribiotech industry of India Ban GM crop trials... Is that the solution? It's the season for incriminating parliamentary standing committee reports it would seem, with the standing committee on agriculture releasing its report â€œCultivation of Genetically Modified Food Crops-Prospects and Effectsâ€? on August 09, 2012, closely on the heels of another report from the Central Drugs Standard Control Organization (CDSCO). The report, a 506 page opus, has among other things recommended an immediate ban on any field trials for transgenic crops. The committee consisted of 31 members of both the houses of the parliament. A number of scientists, leading industrialists, farmers association heads, NGOs, and ministers deposed before the committee over a course of 27 sittings. After more than two years of preparation, the document presents a largely anti-GM stand. The report has recommended that, â€œFurther research and development on transgenics in agricultural crops should only be done in strict containment and field trials under any garb should be discontinued forthwith.â€? Basudeb Acharia, chairman of the committee has gone on record stating that, â€œThe committee has come to the conclusion that since concerns on the potential and actual impacts of GM crops to our food, farming, health and environment are valid, GM crops are just not the right solution for our country. The government should stop parroting the promotional lines of the biotechnology and seed industry and their cronies within the technocracy and stand by scientific reasoning and greater public good.â€? Since almost all political parties were represented in the committee, it questions the future of policy regarding GM research and hence plant biotechnology in India. Dr Seetharama Nadoor, executive director, ABLE-AG has described the report as â€œdisappointingâ€? and â€œunfortunateâ€?. He added, â€œI am not discounting the whole report, but they have to understand that there needs to be a stability in the regulatory process, a kind of predictability especially when the research and development of such products takes 10-15 years. Of course there are things that need to be improved, but there is no need to reject the regulatory policy currently in place, outright.â€? A ban on such field trials would be unlike the moratorium placed on Bt brinjal a few years back, since it would stifle the development of the product at the research stage itself, rather than at the time of commercialization. Dr Nadoor adds, â€œNot allowing field trials for new varieties would be akin to developing a drug but never testing it on humans. Crops are meant to grow in the field. Stopping field trials, would mean all companies are as good as finished and government institutes can only publish papers on their research.â€? The only transgenic crop that has been successfully introduced in India, Bt cotton, is widely studied in the report. The document mentions the positive effect Bt cotton has had on improving cotton productivity in India, but at the same time presents the claims of changes in organ physiology in animals fed Bt cotton seed. Also, the committee has recommended for an â€œall encompassing umbrella legislation on bio-safetyâ€? instead of a biotech regulatory bill. It remains to be seen if this might serve as an additional roadblock in getting the already delayed BRAI bill from getting passed in the parliament. The report has gathered support from all quarters of the anti-GM lobby. Neha Saigal, sustainable agriculture campaigner, Greenpeace India has said, â€œThe standing committee report exposes the serious gaps in our country's GM regulatory system and the lopsided GM technology promotion policies of the government.â€? She added that since only â€œprofit-motivated seed companiesâ€? were to benefit from GM crops, the government needed to rethink its decisions. Dr PM Bharagava, noted scientist, founder and director of Centre for Cellular and Molecular Biology (CCMB) was one of the people who had deposed to the committee and was mentioned in the report as well. The committee pointed out that his recommendations for additional testing of Bt brinjal were not carried out by the GEAC, for whom Dr Bhargava is also a supreme court nominee. As a result, the committee also hints at a â€œcollusion of the worst kindâ€? for the approval of Bt brinjal without the necessary tests. With regards to the report, Dr Bharagava stated, â€œThe standing committee has gone by the evidence which was presented and by what is beneficial for the country. The report was signed by all members of the committee without a single dissent. I think we have a perfect case for stopping all field trials, because we do not have adequate system for assessing biosafety. The only data we have is that which is provided by the company itself, which cannot be relied on.â€? Dr C Kameswara Rao, executive secretary, Foundation for Biotechnology Awareness and Education (FBAE) feels that this is a very biased report where the conclusions were predetermined. â€œThe members have disregarded the people who have given their opinions. Things like cotton seed oil entering the food chain are hyped up without even understanding that oil would contain negligible, if any amounts of protein in it, especially not Bt protein. If the protein does enter our system, Bt proteins are digested just like any other protein in our body,â€? added Dr Rao. Since last year, the regulatory process for GM crops was already in a state of limbo due to the additional requirement of obtaining NOCs from the state governments for conducting field trials. Different governments at the state and national level have differing policies on Bt crops. Manish Tiwari, spokesperson, Congress has however said, â€œWhat I believe in as a lawyer is the integrity of scientific and regulatory processes. There is a tendency in our system to substitute the opinions of genralists for specialists. Complex scientific issues should be best left to scientists who understand their implications and regulatory bodies who have that remit.â€? Previously too, the importance of GM crops for providing food security has been highlighted by the nation's top bureaucrats. Dr Anup Karwa, director life sciences, Krishidhan Seeds Group India echoes this sentiment, â€œIn our opinion, GM technology is the logical advancement of science in the service of society. By stopping introduction in a country like India which is a densely populated country and faces continuous challenges for meeting the food, economic and social need of teaming millions, great harm is being done. It is worth taking a pause and thinking that could we have sustained and progressed without self-reliance in food we developed through introduction of green revolution technologies. India was organic in a sense that we were not using pesticides or fertilizers. Yet we were totally dependent on the US and other developed countries for food that were using both. One must clearly see through the hypocrisy and question why we would want to go back to dark days of hunger and poverty again?â€? What's next? The supreme court, in response to a separate public-interest litigation (PIL), has also appointed a separate five-member committee, comprised of members of the scientific community. This committee, is independently looking into the same matter and preparing a report as well, which is slated for release soon. The findings of this committee will also be important, since its conclusions could strengthen or further weaken the case of genetically modified crops. GM crops have been in the past, and continue to be a highly debated topic, sometimes with more regional and political undertones than scientific ones. They have even been hailed as anti-nationalistic by certain critics who have been quick to point out the role of MNCs such as Monsanto in GM research, but fail to see the 60 plus small and medium sized Indian companies that currently sell genetically modified cotton. A blanket ban on all field trials of GM crops would question the efforts of not only the private enterprises engaged in developing newer varieties, but also the large number of esteemed government institutes such as Tamil Nadu Agricultural University (TNAU), Coimbatore and Univeristy of Agricultural Sciences (UAS), Dharwad and many more who have been actively researching GM crop technology. Dr K K Narayanan, managing director, Metahelix, one of the first companies to successfully release a GM product based completely on Indian research, says that such delays will only hurt the farmers. He adds, â€œThere are thousands of farmers who have taken to this technology much faster than anywhere else in the world. They would not have, if it was indeed such a bad thing. The claim that farmers are forced to buy it, as there is no alternative is misleading, if the farmers wanted non Bt cotton, there would definitely be more companies ready to supply them.â€? For the parliamentary committee recommendation to become a reality, the ban has to be reviewed in the concerned departments and then in both houses of the parliament before it can be passed as a law in our country. With a number of legislations including the Biotech Regulatory Authority of India (BRAI) bill still pending, it remains to be seen if this recommendation will get passed as a piece of legislature any time soon. However the ever changing stance of the government on GM technology along with no clear picture on state and national polices, does paint an uncertain and delayed future for GM crops in India. Dr Naraynan however remains optimistic, â€œThis will however not be the death knell for biotechnology in India. There will be further delays but the farmers cannot be denied the benefits of this technology.â€? Considering the large number of experts consulted in making this report, it would be foolhardy to reject it outright. The need of the hour is for the government to separate political, regional and other such issues and take a strong stand on transgenic crops based on scientific evidence and adopt those measures that are relevant in the Indian context, keeping in mind its socio-economic status. â€œThe standing committee report exposes the serious gaps in our country's GM regulatory system and the lopsided GM technology promotion policies of the governmentâ€? Neha Saigal campaigner, Greenpeace India Manasi Vaidya (with inputs from Rahul Koul) Maharashtra bans Mahyco's Bt cotton On August 9, 2012 the Maharashtra government passed an order to ban the sale of Mahyco's Bt cotton seeds in the state. The ban came close on the heels of reports about the artificial shortage of Bt cotton seeds being created, allegedly by the company, in the market leading to seeds being sold in the black market at more than twice the government stipulated rates. The director of Inputs and Quality Control (DIQC), Sudam Adsule issued an order stating that, â€œUnder the provisions of the Maharashtra Cotton Act, 2009, Maharashtra Hybrid Seeds Company (Mahyco), a joint venture of Monsanto Biotech, is forbidden to carry out its trading activities here. Any violation would attract strict criminal action.â€? Following that, Mahyco issued a statement to the press, stating that it had received the cancellation notice on its license being revoked for the sales of Bt cotton seeds from the government on August 13. Additionally it said that, â€œWe will work with the authorities to reinstate our license in the state. The state government's decision to withdraw the license of the company for selling Bt cotton seeds in Maharashtra is unfortunate.â€? This is apparently not the first time that large seed companies have been found gulity of not adhering to transparent marketing practices. A few years ago, riots had ensued in certain areas in Maharashtra over artificial shortages created by certain companies, leading to the distribution of seeds under police protection. This issue was raised in the legislative assembly by the state agriculture minister, a month back which led to action being taken against the above said company. Mahyco's Bt cotton seeds were reportedly being sold at 2,500 instead of the state appointed price of 930 in the black market. Many sections of the anti-GM lobby such as the Vidarbha Jan Andolan Samiti while hailing the decision, also called for the ban of Bt cotton seeds from other companies to whom Mahyco had outlicensed their technology to. There has been widespread criticism against Bt cotton in the last few years with reports linking it to decreased yields and farmers suicides, and the ban of Mahyco's Bt cotton seeds was being viewed by many, as the state's opinion against cultivating Bt cotton. However, an effort has been made by a number of authorities both political and those belonging to farmers associations that this is not a move against Bt cotton or its technology. When contacted by BioSpectrum, the Maharashtra State Agriculture commissioner, Umakant Dangat clearly mentioned that the decision did not reflect the government's stand on Bt cotton. He added, â€œThe ban on the sale of the Bt cotton seeds by Mahyco is a result of the company creating an artificial shortage of seeds in the market. This does not mean we are against Bt cotton. This is a criminal matter which is an outcome of the malpractices by the company and its dealers who after creating a shortage in the market indulged in black marketeering.â€? Dangat also added that this decision would not affect the seed companies that have out licensed Mahyco's Bt cotton technology, since reports of black marketeering were found only against Mahyco. He also stated that they would initiate such stringent action in case any other seeds companies were also found to indulge in such alleged malpractices. N P Hirani, chairman, Maharshtra State Cotton Growers Marketing Federation too echoed a similar sentiment when he said, â€œThere are a number of reasons why the profits from Bt cotton have gone down in some cases, such as poor rainfall and such. However no one can deny the product enhancement in cotton that has been possible today only because of Bt cotton.â€? Maharashtra grows more than a third of the country's total cotton. Mahyco sold an estimated 35 lakh seed packets in India last year. On the issue of whether this ban might affect the available seeds in the market, Dangat said, â€œThere is no shortage of Bt cotton seeds in the market today. There are many companies who are fully equipped to provide the necessary amount of packets. Land under Bt cotton cultivation of Bt cotton is approximately 40 lakh hectares in Maharashtra. Last year, even though more than 2 crore packets were available, farmers brought approximately 1.25 crore packets only. Hence we had a surplus amount of seed packets with us.â€? Industry insiders however have pointed out the undeniable fact that the timing of this ruling is slightly questionable. The allegations against Mahyco have been reported in different media since almost the start of the kharif season this year, but action was only taken in August, towards the end of kharif season. Though this action can be termed as better late than never if the allegations are proven true, it remains to be seen if this action will have any impact on Mahyco's revenues for the next kharif season. Manasi Vaidya ]]> <![CDATA[1-Jaypee University of Information Technology, Solan]]> https://biospectrumindia.com/news/95/2198/1-jaypee-university-of-information-technology-solan.html https://biospectrumindia.com/news/95/2198/1-jaypee-university-of-information-technology-solan.html Tue, 04 Sep 2012 17:59:00 +0530 Boasting of multi-disciplinary curriculum The department imparts quality education to equip students with skills compatible to the needs of industry and academia The department of biotechnology and bioinformatics at Jaypee University of Information Technology (JUIT), Solan offers four-year BTech programs in biotechnology and bioinformatics, a dual degree five-year MTech program in biotechnology and a six-year dual degree BPharm-MPharm course. The department received close to 4,000 applications for 30 seats in BTech biotechnology. The MTech computational biology started in 2010, received 50 applications out of which five students were admitted. The bioinformatics curriculum includes courses on algorithm design, machine learning, computational high throughput screening and drug designing, bioprograming and scripting languages. The department is equipped with 12-15 labs providing hands-on training in various areas of biotechnology. The overall intention of strengthening research at JUIT has been to expose students to world class research and also provide an opportunity of hands on training on latest technologies. So far close to 134 biotech related research papers from the department have been published in national journals and about 250 research papers in international journals. The department has transferred five products to the industry in the last three years. JUIT has to its credit one patent at national level. The department has been recently awarded an institutional program support in the category of centers of excellence and innovation in biotechnology by the Department of Biotechnology. At a project cost of 8 crore, the program is a first-of-its-kind in India, wherein combination of modern approaches such as genomics, transcriptomics, proteomics, metabolomics and computational metabolic network analysis are to be used to decipher metabolic pathways involved in the production of major chemical constituents in high value medicinal herbs of India. Fact file | Name of the Department: Department of Biotechnology & Bioinformatics Courses: BTech in Biotechnology and Bioinformatics, Integrated MTech in Biotechnology Coordinator: Dr R S Chauhan Website: www.juit.ac.in/Department/bio/bio.php "JUIT has been running programs in biotechnology, bioinformatics and pharmacy which are the three main pillars of bio-based industries, thereby providing a rare opportunity to faculty and students to learn with broad horizons and do projects in a holistic and conclusive manner. The DBT supported institutional program will provide a rare opportunity to a large number of PhD scholars as well as young investigators to develop expertise in modern technologies" Dr R S Chauhan professor & head, department of biotechnology & bioinformatics, JUIT ]]> <![CDATA[How Big is Small?]]> https://biospectrumindia.com/news/95/1235/how-big-is-small.html https://biospectrumindia.com/news/95/1235/how-big-is-small.html Thu, 16 Aug 2012 20:51:00 +0530 Ch. Srinivas Rao The author is Editor of BioSpectrum srinivasch@cybermedia.co.in On the sidelines of an annual symposium on innovation and intellectual property organized by GE at its JFWTC Bangalore center this July, I met Dr Prabuddha Ganguli, CEO, IPR Vision & MHRD IPR Chair, Tezpur University. He showed me his new book titled â€œNanotechnology and Intellectual Property Rights ... Research, Design and Commercializationâ€?. This book, by Ganguli and his co-author Dr Siddharth Jabade, director of innovation and intellectual property rights, Asian Institute of Technology, was launched in India recently. Here are the key observations from the book that are quite a revelation. Nanotechnology in the marketplace has already started to impact every sphere of people's lives as â€œnanovationsâ€? are embedded in various consumer products. As of March 2011, the nanotechnology consumer products inventory contains 1,317 products or product lines. Since the inception of the database in 2005 with 54 consumer products, the inventory has grown year by year with 2006 (356), 2007 (380), 2008 (803), 2009 (1015), and 2010 (1317) showing a growth in the inventory by 521 percent. The numbers in parentheses indicate the number of products. These products span diverse product categories such as health and fitness (738), home and garden (209), automobile (126), food and beverages (105), multifunctional cross cutting (82), electronics and computers (59), appliances (44), and goods for children (30). Nanotechnology has developed in verticals leading to technology-based businesses. Although technologies in some of the verticals may have developed significantly, they may not lead to successful businesses due to multiple reasons. However, due to the all-pervasive nature of the â€œnano,â€? lateral linking of these verticals could lead to partnerships that are mutually symbiotic and open up new and innovative business opportunities. A case in point is that of Evident Technologies one of New York State's first nanotechnology companies. It filed for Chapter 11 bankruptcy protection in July 2009, after being sued for patent infringement by Invitrogen citing mounting legal fees associated with its defense. It had amassed nearly $1 million in legal fees-significant compared to its $3.8 million in assets. Through bankruptcy, Evident and Invitrogen reached a deal. Evident acknowledged it infringed Invitrogen's patent â€œin certain narrow limitationsâ€?. Evident also agreed never to perform life sciences work. In exchange, Invitrogen dropped its lawsuit. On March 31, 2010 a federal judge approved Evident's plan to exit bankruptcy. The company restructured its business and today it is a leading nanotechnology company specializing in the commercialization of quantum dot semiconductor nanocrystals. Every sunrise in the last few decades has been a booster to nanotechnology that has brought several innovations to light. â€œThe new rules of the market ecosystem will demand creative and cooperative competition that will see higher level of precompetitive collaboration operating with higher levels of cautious openness so as to collectively maximise delivery from the minimal resources,â€? concluded Dr Ganguli. ]]> <![CDATA[BioSpectrum Technology Forum - 2012]]> https://biospectrumindia.com/news/95/2493/biospectrum-technology-forum-2012.html https://biospectrumindia.com/news/95/2493/biospectrum-technology-forum-2012.html Thu, 16 Aug 2012 20:36:00 +0530 Next Generation Innovation Celebrating a decade of bioscience innovation Dr S Natesh, senior advisor (Scientist-H), Department of Biotechnology, Government of India, gives the keynote address Dr Ashok Kumar, president, R&D, IPCA, presenting his views on new drug discovery Shivkumar, country manager, Agilent Technologies, introduces company's CrossLab services and supplies BioSpectrum Technology Forum for 2012 was kick-started in Mumbai on July 20. The forum discussed the issues concerning the future of biologics and the emerging innovations. Based around the theme of Next Generation Innovation, the BioSpectrum Technology Forum 2012, held on July 20, 2012, saw R&D heads, important policy-makers, and CEOs brave the Mumbai rains to come together to talk about the current innovation in India. The forum that was supported by Agilent Technologies, provided a platform for all those who gathered there to discuss an array of topics and understand what needs to be done to make India the hub of bioscience innovation. The fact that BioSpectrum too was celebrating a decade of its existence made the theme even more poignant. â€œWe are now in the 10th year of communicating the story of biotech to the Indian community. It has been proven that India has a lot of scope for innovation and this has led to the world looking at India to produce novel and innovative solutions to its problems,â€? remarked N Suresh, group editor, BioSpectrum India, BioSpectrum Asia and Technology Review, while introducing Dr S Natesh, senior advisor (Scientist-H), Department of nology (DBT), the keynote speaker as one of the most authoritative people to speak on innovation in India and on government initiatives to support such innovations. Dr Natesh as a part of the keynote talk, spoke about the various initiatives of DBT such as nology Industry Research Assistance Council (BIRAC), nology Ignition Grant (BIG), and nology Industry Partnership Programme (BIPP). He also emphasized on the need to build human capital when he said, â€œWe have started focusing on linking research with education like launching the IISERs and are also promoting clusters such as those at Bangalore and Mohali. Re-entry fellowships such as Ramalingaswami Fellowship have been very well received. From the 8th to the 11th Five Year plan, DBT's budget grew by 16 times.â€? Along the way, Dr Shivkumar, country manager, Agilent Technologies introduced the company's new line of CrossLab services and supplies designed to streamline the workday of any lab by providing services which cover products of other brands as well. Dr Ashok Kumar, president, R&D, IPCA engagingly delivered a talk on the philosophy behind new drug discovery. Quoting ancient philosophers and scientists alike, Dr Kumar highlighted the need to get back to the basics of drug discovery by developing core competencies and then working with them. Future of biologics manufacturing in India The first panel discussion of the day which focused on the future of biologics manufacturing in India included the heads of India's leading bioscience companies. The panel was moderated by Kaushik Desai, director, DIA India and comprised Dr MK Sahib, director, genomics and biotechnology, Wockhardt Research Centre; Dr Cyrus Karkaria, president, biotechnology, Lupin; Dr Pradeep Nagalkar, manager and head, Haffkine Biopharmaceuticals; and Sai D Prasad, vice president, Bharat . All of them spoke about the difficulties involved in scaling up of biological products and sustaining the quality. Dr Sahib however pointed out that with advancement of technology, this process is getting simpler. Sai Prasad said that building a cGMP compliant infrastructure amidst political instability and regulatory delays is a major challenge, but that all such problems are surmountable. Dr Karkaria also positively added, â€œThe 5-6 companies that do carry out large scale biologics manufacturing in India, do have facilities at par with those in western countries as we have to follow the guidelines stated by them for biologics.â€? The general consensus that emerged however was that regulatory hurdles if reduced, would lead to faster development of India's biologics manufacturing capabilities. Building a strong product pipeline The next panel discussion, centered around â€œBuilding a strong product pipelineâ€?, saw speakers from diverse backgrounds, such as Dr Deven Parmar, CEO and medical director, Americas, Karmic Life Sciences; Chinny Rao, executive director, Transgene Biotek; Dr GD Yadav, vice chancellor, Institute of Chemical Technology (ICT) Mumbai; and Donald Kelemen, vice president business development and corporate strategy, Gennova Biopharmaceuticals. This session was moderated by Anjan Sen, director, strategy and operations, Deloitte India. Keeping in line with the topic, Kelemen spoke about Gennova's ideology, â€œBuilding a pipeline can be very challenging. You have to identify your core competencies, both in science as well as the business aspect and then build the portfolio. We, at Gennova are looking where we want to be in the next five years and then working backwards.â€? Presenting an academician's view on this matter, Professor G D Yadav mentioned, â€œIn India everybody works well in isolation but not as a team. For scalable technology, it is very important that the industry and academia work in collaboration to ensure that ideas produced in the lab get translated in the industry.â€? India is the solution Further continuing the discussion on India's capabilities, the final session was aptly titled â€œIndia as the Solution: Innovative Products can work anywhereâ€?. The panelists included Krishnakumar Sankaranarayanan, associate director, pharma lifesciences, PricewaterhouseCoopers; Dr Neelima Khairatkar Joshi, senior vice president and head, biological and chemical research, Glenmark; Dr BN Ganguli, research advisor KJ Somaiya Trust, former deputy director, R&D, Hoechst Pharma; Dr Shirshendu Mukherjee, strategic advisor, R&D initiatives, Wellcome Trust. This session was moderated by BioSpectrum group editor, N Suresh. Being perceived as the generics capital by most of the western world, innovation in India is still said to be in its infancy as compared to other countries. Sankaranarayanan, however, pointed out that, â€œIndia has one of the key advantages of scale. Barring China, very few countries have such a huge pool of manpower. Also need for solutions is a major driver for growth in research.â€? Dr Neelima Joshi elaborating on how Glenmark was becoming innovation proficient said, â€œGlenmark is in the process of out-licensing its novel first-in-class programs to leading pharma companies. This model allows innovative research to be awarded and presents a niche opportunity to Indian companies as big pharma is looking for cheaper solutions.â€? Dr Mukherjee who has been closely associated with funding innovative solutions through the aegis of the Wellcome Trust also spoke about how Wellcome Trust is closely working with over 14 projects in India that are focused on affordable innovation. Speaking at the forum, Sandeep Tandon general manager - India, chemistries and supplies division, Agilent Technologies India, said, â€œAgilent CrossLab is a brand new supplies portfolio for major brands of non-Agilent analytical instruments. The goal is to improve productivity and efficiency through quality, availability, and support.â€? The new HPLC offerings, combined with its existing CrossLab GC supplies will enable its customers to find the right supplies across multiple instrument brands. â€œAgilent recognizes that laboratories are often equipped with instruments from a range of vendors, and we are committed to facilitating multi-vendor repair, maintenance and compliance across services and supplies. Agilent is uniquely qualified to be a lab-wide service provider and provide single-source laboratory services across any site or organization,â€? added Bharat Bhardwaj, general manager - India, service and support division, Agilent Technologies India. The event was successfully concluded with the handing over of mementos to the speakers, with the promise of more chapters of this event in other cities as well. Manasi Vaidya BSTF SESSION - 2012 Future of biologics manufacturing From left: Kaushik Desai, director, DIA India; Dr Cyrus Karkaria, president, biotechnology, Lupin; Dr M K Sahib, director, genomics and biotechnology, Wockhardt Research Center; Dr Pradeep Nagalkar, manager and head, Haffkine Biopharmaceuticals; Sai D Prasad, vice president, Bharath Building strong product pipeline From left: Anjan Sen, director, strategy & operations, Deloitte in India; Prof. G D Yadav, vice chancellor, ICT Mumbai; Donald Kelemen, vice president, business development & corporate strategy, Gennova Biopharmaceuticals; Chinny Rao, excutive director, Transgene Biotek; Deven Parmar, CEO and medical director, Americas, Karmic Life Sciences India is the solutionFrom left: Narayanan Suresh, group editor, BioSpectrum; Dr Shirshendu Mukherjee, strategic advisor, R&D initiatives, Wellcome Trust; Dr Neelima Khairatkar Joshi, senior vice president & head, biological and chemical research, Glenmark; Dr B N Ganguli, research advisor, KJ Somaiya Trust, former deputy director, R&D, Hoechst Pharma; Krishnakumar Sankaranarayanan, associate director, pharma lifesciences, PwC Bharath Bhardwaj, general manager-India, service and support division, Agilent Technologies, India Sandeep Tandon, general manager-India, chemistries and supplies division, Agilent Technologies, India ]]> <![CDATA[LAB INSTRUMENTATION]]> https://biospectrumindia.com/news/95/2548/lab-instrumentation.html https://biospectrumindia.com/news/95/2548/lab-instrumentation.html Thu, 16 Aug 2012 20:35:00 +0530 Lackluster trend interrupts growth Slump in research and development expenditure by the public sector institutes coupled with recession in the Indian economy affected the growth rate of lab instrumentation market The lab instrumentation market primarily consists of centrifuges, flow cytometry, PCRs and to some extent the upcoming segments such as gene sequencing. While the market for instruments in FY 2010-11 witnessed a 30 percent growth, FY 2011-12 saw a sharp decline in growth ranging between 10-12 percent. This slowdown in growth was primarily due to the research and development (R&D) budget cuts in the public sector (mainly research institutions), academic institutions and universities gradually closing down courses in biotech (due to low employment prospects) and above all, the slow GDP growth of the Indian economy. Experts are apprehensive that with the volatility of the Indian rupee vis-a-vis the US dollar, a further lag in the coming months is expected since most of the lab instrumentation products are imported from markets such as the US. This means not just a drop in revenues but a drop in terms of volume and deferment of orders. Clearly, the same set of players continue to dominate the market which include companies such as AB SCIEX, Beckman Coulter (acquired by Danaher), Becton Dickinson, BioRad, Eppendorf, GE Healthcare, Perkin Elmer, Roche, and Thermo Fisher Scientific. Market segments and trends The centrifuge segment, which is primarily a tender-based market continues to see a slowdown again owing to drop in government funding towards this sector. According to experts, around 60-70 percent of the revenues comes from the government. The vaccine sector is a major revenue churner for this segment. The Indian vaccine market dominated by a handful seven-eight players which makes the scope for centrifuge players very limited. Unless these companies give huge order or are in an expansion mode, there will not be much of purchase and installation of centrifuges. The segment can be further divided into ultra centrifuges, high-speed centrifuges, high capacity centrifuges, general table top centrifuges, industrial centrifuges and blood bank centrifuges. Overall the market grew at an average rate of 10 percent and its size is between $15-20 million in India. High speed, high capacity and blood bank centrifuges together have the maximum market share of around 30-40 percent. Together, they have an amalgamated revenues of $7-8 million with high speed growing at eight-10 percent clocking a market size of $3-4 million. Thermo Fisher Scientific is a leading player in high capacity centrifuges. The ultra centrifuges segment has a market size between $4-5 million growing at a rate of 12-15 percent. Beckman Coulter (acquired by Danaher), ThermoFisher Scientific are the leading players in the segment. Most of the ultra centrifuges are used for research activities. Table top centrifuges clocked a market size between $6-8 million. This is the fastest growing market today, because it has become a mandatory requirement for every laboratory and research center to have a table top centrifuge. A total of eight million table top centrifuges were installed over the past one year. Eppendorf and ThermoFisher Scientific together have a market share of 50 percent. The industrial centrifuges market is dominated by Alfa Laval. The flow cytometry market garnered sales of 140 crore which can be broken up into three major segments such as research, clinical, and industrial. This market is growing by 20-22 percent. Core research institutes in India have deep penetrations of flow cytometry with lesser headroom to grow. But higher education segment, including medical colleges, has huge potential for instrumentation and research reagents. The clinical market is driven by AIDS monitoring, leukemia and lymphoma monitoring, and cord blood banking. This segment provides good growth for consumables and reagent business. Personal analyzers and sorters will attract major research market. However, industrial segment has not shown much promise. Becton Dickinson, by far, is the leading player in the flow cytometry market. The PCR market, which at one point was growing at around 25 percent, is now growing at a growth rate between 12-15 percent. This is because it has reached a stabilization point. A total of around 20 players operate in the segment. The market can be further divided into real time PCRs and classical PCRs, with the shift gradually moving towards real time PCRs. Real time PCRs recorded a growth of 30-35 percent due to the growth of the molecular diagnostic sector in India while classical PCRs recorded a growth of 15 percent. BioRad and Eppendorf lead the real time PCRs segment. A total of 1,200 units of classical PCRs were sold with an average price of 1.7 lakh, while around 300-400 units of real time PCRs were sold with an average price of $ 25,000. The public sector mainly academic institutes and colleges are the main customers for PCRs. Also the market is seeing increasing competition especially from Chinese players. In the field of gene sequencing, an upcoming area within this segment, the major trend is the next generation sequencing (NGS). The technology by Pacific Biosciences is a disruptive technology that takes care of all the nemeses of the NGS at a striking 1/10th of its cost per sample. Having an average read length of approximately 3,000 bps (with highest documented up to 8,000bps); the data is much cleaner and also takes care of overlapping. Also, the recurring cost per sample is as low as $350, when compared to $8,000 cost per sample of NGS. It has been brought to India by Imperial Life Sciences in August, 2011. | Highlights AB SCIEX, Beckman Coulter (acquired by Danaher), Becton Dickinson, BioRad, Eppendorf, GE Healthcare, Perkin Elmer, Roche, and Thermo Fisher Scientific continues as key players Centrifuges market grew at an average rate of 10 percent, its size being $15-20 million PCR market is growing at a rate of 12-15 percent ]]> <![CDATA[MASS SPECTROMETRY]]> https://biospectrumindia.com/news/95/1145/mass-spectrometry.html https://biospectrumindia.com/news/95/1145/mass-spectrometry.html Thu, 16 Aug 2012 20:34:00 +0530 A favorable forecast for MS domain Despite a number of challenges, the MS market in India continues to grow with existing players stepping up their operations to beat competition BioSpectrum estimates have spotted the overall mass spectrometry (MS) market size in India to be at $65 million, growing at an average rate of 15 percent over last year. The mass spectrometry market can be roughly divided into four sectors, mainly liquid chromatography MS which commands the lions share standing at $45million, gas chromatography MS (GCMS), inorganic MS and elementary MS. Of these the GCMS segment estimated to be $12 million, has been rising up to its potential by growing at a healthy 15 percent and has displayed ample potential as well. The high technology nature of this segment has ensured that companies such as AB Sciex, Waters, Agilent, and Thermo Fisher remains as the top players to reckon with, this year too. The ability to provide good technical support to customers through companies' analytical labs has been a differentiating factor among the major players. Current market scenario AB Sciex continues to dominate by holding over 40 percent market share, while Waters has been closing in on its competitors by increasing its market share to 30 percent as compared to 25 percent last year, having sold over 65 units in this category. Additionally, Thermo Fisher continued to hold a share of 15 percent and has the plans of further increasing it after they acquired Dionex last year. Bruker has been showing good signs of progress by increasing its market share to approximately 10 percent. The predominant share, in terms of demand for MS instruments, has always been held by the pharma industry, with industry sources estimating it to be over 60 percent. However, last year saw a lot of pharma companies and CROs shy away from making major investments due to regulatory issues, leading to a slight decline in number of orders received. The public sector, consisting of academic and government labs constitute about 18 percent of the market. A number of factors will continue to influence the market, in the next year, mainly the increased expenditure that is expected, once the allocation for scientific research in the 12th Five Year plan is realized. The plan puts educational institutes in a better position to make large purchases such as that of MS instruments. A host of new products were introduced into the market last year. Waters released three products including a tandem quadrupole mass detector (TQD). AB Sciex too launched triple quadrupole detectors, equipped to handle qualitative and quantitative features in metabolite identification, proteomics research and biomarker discovery, which have been received favorably by the research community. Industry sources have stated that the year 2012 has started out on a better note with leading companies having secured a greater number of orders than the same period last year. Many companies such as Waters have thus reported a more positive outlook for the days to come for mass spectrometry segment. | Highlights Estimated revenue for MS segment is $65 million, recording a 15% growth when compared to last year Liquid chromatographic MS grosses major share of $45 million AB Sciex continues to dominate, while Waters, Agilent and Thermo Fisher are key players Public sector holds18% share ]]> <![CDATA[BIOPROCESS MARKET]]> https://biospectrumindia.com/news/95/7569/bioprocess-market.html https://biospectrumindia.com/news/95/7569/bioprocess-market.html Thu, 16 Aug 2012 20:32:00 +0530 Competition-driven market scenario The market continues to trod on the growth mode with single use fluid devices and disposables being a continuing trend among biotechnology companies in India The bioprocess segment continues to witness an upward trend in its growth curve, thus hitting the mark of 20 percent for FY 2011-12 vis-a-vis last year's moderate growth rate of 12 percent. The segment clocked revenues of 604.8 crore as against 504 crore during the FY 2010-11. The same set of players continue to dominate the market with Pall Life Sciences, Merck Millipore (formerly known as Millipore) being the biggest players, followed by Sartorius. GE Healthcare has established its position for its specialized variety of filtration products. Around 60 percent of the business within this segment comes from the pharmaceutical sector followed by companies in the biotechnology sector. This is primarily because the scale of production in the pharmaceutical sector is much more than the biotechnology sector. Market segments and trends The market can be further subdivided into three levels namely, bulk filtration, coarse filtration and fine filtration. Within the segment of bulk filtration, Sartorius is a market leader with a share of around 35 percent. The fine filtration is by far the largest sub-segment within the bioprocess segment Pall Life Sciences, Sartorius and Merk Millipore being the leading names in the market. In the coarse filtration segment which is a 30 crore market, indigenous companies such as Pharma Labs have been doing substantial business over the recent years. As observed in the recent past, application of single-use fluid devices and disposables has become an increasing trend among companies and is predicted to be a continuing norm in the coming years. Compared to multiple-use devices, such devices are easy to use, chances of cross contamination kept to the minimum and there has been an increasing demand among the regulatory authorities towards the use of disposables and single-use fluid devices. This is applicable to biopharmaceutical sector mainly the vaccine sector and companies into exports, where stringent safety norms need to be followed especially for their consignments. Within this segment, Sartorius has the largest portfolio of single-use bioprocess devices and disposables and has a strong footing within the segment. Experts from the industry claim that unlike other segments, this market is scheduled to grow in the coming years due to the rise and prominence of a lot of indigenous players in the market. This could prove to be a major boost for a market which till date has been dominated by MNC players. | Highlights Bioprocess segment is growing at a rate of 20 percent and clocked revenues of 604.8 crore for FY 2011-12 MNC players continue to dominate the market with Pall Life Sciences and Merck Millipore being the largest players Regulatory authorities prefer companies using disposables and single use fluid devices ]]> <![CDATA[CHROMATOGRAPHY MARKET]]> https://biospectrumindia.com/news/95/2520/chromatography-market.html https://biospectrumindia.com/news/95/2520/chromatography-market.html Thu, 16 Aug 2012 20:30:00 +0530 Chromatography records 20% growth The favorable market dynamics in India coupled with the technological advancements in instrumentation have propelled the growth of chromatographic separation market The estimated 1,300 crore strong chromatography market continues to hold a major share of the total biosupplier market revenue. The market continues to grow at a rate of 20 percent. Dominated by high performance liquid chromatography (HPLC), the chromatography market also includes the important sub-segments such as liquid chromatography (LC), gas chromatography (GC) and ultra-high performance liquid chromatography (UHPLC). Agilent Technologies and Waters equally control around 70 percent of the market, followed by Shimadzu and Thermo Fisher, both having a staunch presence in the segment. The overall analytical instruments market which is said to be close to 6,000 crore, has also showed consistent growth over a period of time. Growth drivers and market trends The growth drivers for this market include the government investments in academics, life science applications 'Omics', growth in generics and CROs, and therapeutic conversion to new biological entities. While the life science applications in pharma biotech and environmental industries account for close to 80 percent of the market revenue, 10 percent each is shared by national laboratories and other government institutes. The total HPLC market of India is estimated to be around 600 crore, witnessing a growth of over 15 percent for fiscal year 2011-12. The tremendous increase in the number of quality control, method development, research, and drug discovery laboratories has been the driving force for the HPLC market. Another sub segment has been increasing its presence substantially. This particular sub-segment, UHPLC is said to gain another 5-10 percent of the market in the next 2-3 years. The Indian ion chromatography (IC) market is quite small as compared to the rest, but is rapidly increasing at an estimated rate of 20 percent. The same is attributed to its usage in environmental monitoring. Dionex holds the major low-end market, which is shared between Dionex and Metrohm. Gas chromatography is said have grown at the rate of six percent in 2011. The dominant player includes Chemito followed by Agilent, Perkin Elmer, Shimadzu, and Thermo Fisher. The visible trend in this segment is the gradual shift towards gas chromatography-mass spectrometry (GC-MS). Developments and opportunities The technological advancements with advent of systems for faster analysis have also opened up newer opportunities of growth, notably for UHPLC, monolithic columns, and hydrophilic interaction chromatography (HILIC). Monolithic columns hold great potential for very fast separations. Despite the possible adverse economic conditions, the government funding towards R&D is still expected to increase. Therefore the chromatography segment is expected to maintain at least a minimum of 15 percent growth rate in the current financial year as well. | Highlights Growing at an average 20% rate, HPLC constitutes a major chunk of the chromatography market Indian pharmaceutical industry accounts for more than 65% for the HPLC market Waters & Agilent continue to dominate the segment UPLC is the fastest growing LC market segment dominated by Waters (60%) followed by Agilent (17%) and Shimadzu (8%) ]]> <![CDATA[10-Shree Manibhai Virani & Smt Navalben Virani Science College, Rajkot]]> https://biospectrumindia.com/news/95/7158/10-shree-manibhai-virani-smt-navalben-virani-science-college-rajkot.html https://biospectrumindia.com/news/95/7158/10-shree-manibhai-virani-smt-navalben-virani-science-college-rajkot.html Thu, 16 Aug 2012 20:17:00 +0530 Emphasizing scientific values By supporting training activity, the college continues to excel in bioscience education in Gujarat Shree Manibhai Virani and Smt Navalben Virani Science College affiliated to Saurashtra University, was established in 1968 and subsequently received recognition from UGC in 1976. The college is run by the Sarvodaya Kelavani Samaj which endeavors to synthesize spiritual, scientific and technological achievements to bring about harmonious and integrated development of young minds. Among the various departments at the Virani Science college, the department of biotechnology offers bachelors and masters courses in biotechnology. During the academic year 2011-12, the department received 500 applications for the BSc biotechnology program, out of which 68 students were selected. For the masters course, 40 students were admitted against the 650 applications received by the department. A substantial number of students are also carrying forward their PhD at the department in the areas of plant tissue culture, bioinformatics and plant molecular biology. The infrastructure at the department has a well maintained library with versatile collection of books, e-books and periodicals. The instrumentation in the department consists of various equipment such as gel documentation system, PCR, centrifuge systems, sequencing, gel electrophoresis, to name a few. There are 27 faculty members with above three years of experience. The department has published about 53 research papers in the national journals and about 40 papers in the international journals. There are a total of nine labs in the department which can accomodate 40 students. Since 2007, the number of government sponsored projects at the department amounted to 5 crore. Similarly projects worth 1.5 crore were sponsored by the private industries.The college has a placement cell on its campus to cater to the requirement of the companies. During the last academic year, about 19 companies visited the college for placement purpose. The college plans to augment educational programs by introducing courses in management, nursing, ayurveda, dentistry, and medicine to cater to the societal needs. Fact file | Name of the Department: Department of Biotechnology Courses: BSc and MSc in Biotechnology Coordinator: Prof. Shivani Patel Website: www.vsc.edu.in "The innovative study programs at our college lay an added emphasis on study of pharmaceuticals and proteomics. The institute is also designated as a star college by DBT. We organize expert lectures which enables our students to successfully submit research proposals on a national level, through which they win fellowships." Prof. Shivani Patel HoD, Shree M & N Virani Science College ]]> <![CDATA[8-The Oxford College of Science, Bangalore]]> https://biospectrumindia.com/news/95/2314/8-the-oxford-college-of-science-bangalore.html https://biospectrumindia.com/news/95/2314/8-the-oxford-college-of-science-bangalore.html Thu, 16 Aug 2012 20:15:00 +0530 Visiting faculties are assets Improving its industry interactions over the last year, Oxford College now looks at investing in infrastructure development The Oxford College of Science offers a number of courses in the biotechnology space affiliated to different universities. The MSc biotechnology program affiliated to Bangalore University saw 40 students being admitted in the last academic year, most of whom were either JNU or CSIR NET qualified. The M Phil in biotechnology is affiliated to both Bharathidasan University and Periyar University. The PhD in molecular biology and biotechnology is affiliated to Jawaharlal Nehru Technological University and has a total of five students currently pursuing it. Almost half of the faculty members possess a PhD with more than five years experience. The unique selling proposition of the institution is that a number of eminent industry and academicians serve as visiting faculties on a regular basis. Last year the students were taught by 23 visiting faculty. The institute has in the past collaborated with various other institutes such as Indian Institute of Science, University of Agricultural Sciences, Bangalore University and Gulbarga University. The college has tie-ups with different companies such as Avesthagen, Bhat Biotech, Xcyton Diagnostics, Apollo Hospitals, Biocon, and Syngene for the industry projects. The management also has plans to invest in expanding the existing infrastructure, especially in the areas of molecular diagnostics. Since 2008, the college has published 54 papers in international journals, with 65 in national journals. A lot of emphasis is laid on the mandatory industry projects for students, as a consequence of which, last academic year saw 10 papers being published as a result of the students' thesis dissertation. Since 2009, the institute has secured industry sponsored projects worth 41 lakh and government sponsored projects totalling 2.87 crore. The institute also receives 5.75 lakh through the royalties obtained on the bioinformatics product transferred to the industry. Since 2008, the institute has filed for four Indian patents and three international patents, related to bioinformatics software developed by the teaching staff. The institute has invested in improving the infrastructure as evidenced by the 2.36 crore spent for improving the lab facilities. Fact file | Name of the Department: Department of Biotechnology Courses: MSc and MPhil in Biotechnology; BTFS Program Head: Prof. Vedamurthy A B Website: www.theoxford.edu "We insist on students doing research during their projects and encourage them to publish papers based on that." Prof. Vedamurthy A B HoD, department of biotechnology, The Oxford College of Science ]]> <![CDATA[7-KIIT University, Bhubaneshwar]]> https://biospectrumindia.com/news/95/2152/7-kiit-university-bhubaneshwar.html https://biospectrumindia.com/news/95/2152/7-kiit-university-bhubaneshwar.html Thu, 16 Aug 2012 20:14:00 +0530 Transforming ideas into products Association with several world-class laboratories allows students to benefit from the scientific knowledge and exchange programs Established in 2007 as a constituent of KIIT University, school of biotechnology (KSBT) was first in Orissa to have integrated academic and research programs. With its foundation stone laid by Professor Richard R Ernst (Nobel Laureate in the field of NMR, 1991), KSBT heralds a new era of science with a broad vision in the state of Orissa. The school offers BTech, MSc and PhD courses in biotechnology. Out of 1,137 applications received by the school in the academic year 2011-12, 60 students were granted admission to MSc biotechnology course. KSBT boasts of ultramodern laboratory facilities. Apart from having a well equipped bioinformatics lab, all the students at the department are provided a free laptop. The school so far has published six biotechnology related research papers in the national journals and 26 research papers in the international journals. The school hosts one international conference, one national conference and 5-6 workshops every year. The school has tie-ups with 13 international laboratories and 11 national biotech industries. In future, the school is aiming to establish the center for translational research and center for interdisciplinary science and material sciences. According to the school, the students are given hands-on experience on various modern tools, important for biotechnology sector. Interestingly, the department has created a research and development hub by integrating researchers, technology business incubator (established with biotech focus, supported by NSTEDB, DST), technology commercialization facilitating agency (TCFA), supported by TIFAC, DST, and innovation center, promoted by the KIIT university. Currently, 11 innovative ideas in the school are under incubation and two of them have already been commercialized. The school organizes several workshops, training programs and international conferences. The school has also started international collaborative work to explore and understand the hidden scientific treasure of Chilika lake (largest brackish water lagoon). Fact file | Name of the Department: School of Biotechnology Courses: MSc & PhD in Biotechnology Director: Prof Mrutyunjay Suar Website: www.kiitbiotech.ac.in "This is the only school of biotech where the students and faculties visit various reputed international laboratories for a period of one month to one year, supported by host institute fellowship programs." Prof Mrutyunjay Suar professor and head, School of Biotechnology, KIIT University ]]> <![CDATA[5-Vellore Institute of Technology University, Vellore]]> https://biospectrumindia.com/news/95/1871/5-vellore-institute-of-technology-university-vellore.html https://biospectrumindia.com/news/95/1871/5-vellore-institute-of-technology-university-vellore.html Thu, 16 Aug 2012 20:10:00 +0530 Rides on international tie-ups VIT is forging ahead and strengthening its collaborations with industry and academia to help expose its students to biotech research Vellore Institute of Technology popularly known as VIT offers a number of UGC aprroved degrees in biotechnology and biomedical engineering. One of the most unique factors about the institute is that the college has one of the largest numbers of PhD qualified teaching staff in the country. The institute has faculty of 120 professors, 89 of whom are doctorates. These professors have successfully published in 210 international journals and 140 national journals in the last four years. There have been a number of luminaries visiting on a regular basis from Singapore, Germany, and Zurich. Also 1.65 lakh was received as royalties by some of these faculty members who have published books. Currently there are 42 ongoing projects sponsored by government agencies such as DST, DBT, ICMR, CSIR, DoAE and the state government of Tamil Nadu worth 6 crore along with an additional 75 lakh from DST FIST. Also there have been industry sponsored projects to the tune of 10.5 lakh since 2009. A number of guest lectures, seminars and workshops were carried out last year at VIT, both by the in-house faculty as well as other academicians. As a result of the research carried out at VIT, two products have been successfully transferred to the industry. They are a method for glucose oxidase production to TCL, Ranipet and selenium enriched food products to VKP sons, Rajapalayam. The department has filed for nine Indian patents and three international ones since 2008. These patents mostly deal with novel biomaterials, enzymes and techniques in fermentation technology. The department has spent a staggering 4.05 crore for the improvement of its laboratory infrastructure since 2009. There are 24 teaching labs with a capacity of 50 students and 22 research labs with the capacity of 15 students. A host of life sciences companies such as Mahyco, Biocon, Dr. Reddy's, Agilent Technologies, Piramal Healthcare, and Omics made 67 placement offers. Some of the international collaborations include those with John Wayne University; Fribourg University in Switzerland; University of California; and University of Hannover, Germany. Fact file | Name of the Department: School of Biosciences and Technology Courses: BTech Biotechnology, Bioinformatics, Biomedical Eng, MTech Biotechnology, Biomedical Eng, PhD Director: Prof G Anilkumar Gopinathan Website: www.vit.ac.in/sbst/sbst.asp "VIT has MoUs with over 150 national and international universities which help students pursue their higher studies and also carry out their final year projects. These MoUs enable faculty members to conduct research in collaboration with others." Prof G Anilkumar Gopinathan director, school of biosciences and technology, Vellore Institute of Technology ]]> <![CDATA[4-Manipal Life Sciences Centre, Manipal University, Manipal]]> https://biospectrumindia.com/news/95/2121/4-manipal-life-sciences-centre-manipal-university-manipal.html https://biospectrumindia.com/news/95/2121/4-manipal-life-sciences-centre-manipal-university-manipal.html Thu, 16 Aug 2012 20:09:00 +0530 Preparing for productive growth Manipal Life Sciences Centre allows students to benefit from the excellent research facilities and placement opportunities The Manipal Life Sciences Centre has secured the fourth rank in this year's BioSpectrum Top 20 survey, thus re-establishing its presence as one of the top BT schools in India. Last year Manipal started a PG Diploma in Cellular and Molecular Diagnostics as a part of the BT finishing school program which was received favorably with 11 students taking part in this initiative. Over the last three years, the research conducted at Manipal has resulted in the application of nine patents in India regarding molecular epigenetic markers in different types of cancers through microarray analysis. The center has colloborated with Philips as a part of the project for identifying the disease causing epigenetic markers in breast cancer. Over the past three years, Manipal has received funds to the tune of 68.73 lakh, through industry sponsored projects. These projects include those with Cipla for anti cancer drugs, Stempeutics for stem cell products and other companies for research in developing and purifying recombinant proteins and antibodies. One of the differentiating factors in the masters program is the duration of the final semester project which is nine months, allowing the students to conduct good research either in the industry or on campus itself. A variety of conferences were conducted on the campus over the last year to offer additional exposure to students. Also Manipal has been at the helm of organizing the DST sponsored INSPIRE program, for school students. It also conducted industry sponsored workshops to provide training in specialized techniques. Most of its students who pass MSc invariably and successfully seek PhD admissions in India and abroad. The admission for these courses is carried out based on the scores obtained in a special entrance exam. The Manipal Life Sciences Centre also has tie-ups with international universities such as Masstricht University, Edinburgh University, and Liecester University in Europe and Flinders University and Queensland University in Australia for easier facilitation of students wishing to pursue their PhDs. Fact file | Name of the Department: Division of Biotechnology Courses: MSc in Medical Biotechnology, Bioinformatics, and Molecular Biology & Human Genetics, PhD in Biotechnology and Molecular Biology, PG Diploma in Cellular Biology and Molecular Diagnostics Coordinator: Prof K Satyamoorthy Website: www.manipal.edu "Our emphasis on basic sciences is very good. Also the opportunity to work with senior researchers during the student's final year projects provides the students with the necessary hand holding and best training for the future." Prof K Satyamoorthy head, division of biotechnology, Manipal Life Sciences Centre ]]> <![CDATA[2-Shoolini University of Biotechnology & Management Sciences, Solan]]> https://biospectrumindia.com/news/95/8130/2-shoolini-university-of-biotechnology-management-sciences-solan.html https://biospectrumindia.com/news/95/8130/2-shoolini-university-of-biotechnology-management-sciences-solan.html Thu, 16 Aug 2012 20:06:00 +0530 Meeting international standards The school has established links with prominanent industries for creating an employability bridge Established in 2009, school of biotechnology and applied sciences at the Shoolini University of Biotechnology and Management Sciences offers courses such as MSc, MTech in Biotechnology, MBA in Biotechnology, and M Phil. The students are admitted to the courses through rolling test conducted by Shoolini University followed by personal interview. In 2010-11, out of about 103 applications received, 52 students were admitted to the MSc Biotechnology course. The infrastructure and facilities of the school are complimented by international academic alliances with Seoul National University, South Korea; National Hampshire University, USA; and Chung Yuan Christian University, Taiwan for transfer of credits and student exchange programs. A number of projects of the school have received funding to the tune of 4.4 crore from the industry and 4.1 crore from government agencies. The faculty of the school has vast experience in formulating and handling biotechnology related national and international projects, under the overall guidance of Professor PK Khosla, former vice-chancellor, HPAU, Palampur and ex-advisor, Biotechnology, Government of Himachal Pradesh. The curriculum has been designed in consultation with stakeholders so that it meets the requirements of academia, industry and society. The school claims to have state-of-the-art-laboratories to handle advanced research. The school is in the process of creating a database library on medicinal and aromatic plants. The school has been providing of industry exposure to the students from time to time. Companies such as Panacea Biotec, Krishidhan, Dabur International, Syngenta, Johnson & Johnson, Nectar Life Sciences, Genpact, Ranbaxy, Torrent Pharmaceutical, Meridian Pharmaceutical and many others have visited the campus to recruit the students. In 2011-12, about 139 graduates from various post graduate courses have found placements in the industry. Fact file | Name of the Department: School of Biotechnology and Applied Sciences Courses: MSc, MTech & MBA in biotechnology Director: Professor P K Khosla Website: www.shooliniuniversity.com "Our biggest strength is our faculty which consists mainly of people who have completed their PhDs. They are responsible for starting a number of government and industry sponsored research programs. Our experience with organizing campus placements has also been very fruitful this year. Our biggest strength is our faculty which consists mainly of people who have completed their PhDs. They are responsible for starting a number of government and industry sponsored research programs. Our experience with organizing campus placements has also been very fruitful this year." Prof. P K Khosla Vice Chancellor, Shoolini University ]]> <![CDATA[11-Banaras Hindu University, Uttar Pradesh]]> https://biospectrumindia.com/news/95/8298/11-banaras-hindu-university-uttar-pradesh.html https://biospectrumindia.com/news/95/8298/11-banaras-hindu-university-uttar-pradesh.html Thu, 16 Aug 2012 19:57:00 +0530 Joins 'most preferred' club Established in 1986, the school of biotechnology at Banaras Hindu University is among the top three preferred biotech programs in the country. In the academic year 2011-12, 19 students were admitted out of 27 applications received by the school from joint entrance examination held by JNU. Around 253 biotech related research papers have been so far published in the international journals.The best achievement for the department was that the percentage of students qualifying in national test for fellowships was 100 percent. The school has been the proud recipient of a letter of appreciation from Department of Biotechnology, Ministry of Science and Technology, Government of India. DBT in its letter dated November, 2011 has praised the MSc programs of the school and ranked it among top few. Fact file | Name of the Department: School of Biotechnology Courses: MSc and PhD in Biotechnology Coordinator: Prof. Sukh Mahendra Singh Website: www.internet.bhu.ac.in/science/biotech/index.html 12-Shivaji University, Kolhapur Looking at placement offers Shivaji University's department of biotechnology was established in 2003. The MSc molecular biology and biotechnology course is recognized by the UGC, State Government of Maharashtra. For academic year 2011-12, there were 440 forms received for the MSc (Ag) molecular biology and biotechnology, out of which 30 students were enrolled for the course. Presently, there are 22 PhD students working in the department. There are nine full-time faculty members having a work experience of more than five years. The department also invites visiting faculty to deliver lectures to students. In terms of infrastructure, the department has 10 labs having a capacity to accommodate 15 students. Between June 1, 2008 and May 31, 2012, a total of 69 research papers were published in international journals, while five papers were published in national journals. Fact file | Name of the Department: Department of Biotechnology Courses: BTech, MSc and PhD courses Head: Dr Jyoti P Jadhav Website: www.unishivaji.ac.in 13-Kumaun University, Uttarakhand Providing balanced facilities The department of biotechnology at Kumaun University was established in the year 2000. The activities of the department are focused on quality teaching program. During the year 2011-12, the number of students admitted to MSc program stood at eight out of 15 applications received by the department. The admissions are based on the All India Entrance Examination conducted by JNU, New Delhi and supported by DBT. The department has signed MOUs with most of the ICAR and CSIR institutes of the region for networking projects, use of lab facilities and registering their research fellows for PhD. The department has all modern facilities in terms of equipment, chemicals, and glasswares. Since 2003, 32 research papers from the department have been published in the national journals and 38 in international journals. Fact file | Name of the Department: Department of Biotechnology Courses: MSc and PhD in Biotechnology Head: Dr Veena Pande Website: www.kubic.nic.in 14-University of Burdwan, West Bengal Exploring the Arctic Established in September 2003, the department of biotechnology at the University of Burdwan (NAAC accredited) has been supported by DBT since 2006, both for infrastructure development and for assistance to the students. Out of the 150 applications received for the course, a total of 25 students were selected for the year 2011-12. Apart from two general labs for routine practicals, the department also has a specialized laboratory. The department has published 35 research papers in international journals and seven research papers in national journals. A recent development has been the project on â€œexploration of Arctic micro-organismsâ€? where the department has been included in the national program organized by National Centre for Antarctic and Ocean Research, Goa. Fact file | Name of the Department: School of Biotechnology Courses: MSc and PhD in Biotechnology Coordinator: Pranab Roy Website: www.buruniv.ac.in 15-Govt Post Graduate College Bilaspur, Himachal Pradesh 60 years of service Government Post Graduate College, Bilaspur was established in 1952 and is one of the oldest and most prestigious colleges of Himachal Pradesh. This college has been notified by the university as one of the top five colleges among the 72 colleges affiliated to university. Accredited with B++ Grade by NAAC, this college has established a glorious record of excellence and notable achievements in academics, sports, cultural and other fields over the last fifty six years. Since 2008, the college has published four research papers in national and one in international publications respectively. The college provides education in arts, science and commerce facilities. The college has well equipped laboratories, along with NCC and NSS facilities. Fact file | Name of the Department: Department of Biotechnology Courses: BSc in Biotechnology Coordinator: Prof. Neelam Sharma Website: www:gpgcollegebilaspur.in ]]> <![CDATA[10-Jamia Hamdard, New Delhi]]> https://biospectrumindia.com/news/95/6455/10-jamia-hamdard-new-delhi.html https://biospectrumindia.com/news/95/6455/10-jamia-hamdard-new-delhi.html Thu, 16 Aug 2012 19:56:00 +0530 Targeting new milestones The department has partnered with various government agencies and industries to provide hands-on training to the students The department of biotechnology at NAAC â€œAâ€? accredited Jamia Hamdard deemed university was established in 1997. The Department offers MSc and PhD courses in molecular biology and biotechnology. The students are selected on basis of the national level admission test conducted by Jamia Hamdard. In the academic year 2011-12, the number of students enrolled for the post-graduate program stood at 38. The department has state-of-the-art facilities for gene cloning, delivery and expression in mammalian cell, insect cells, microbes, and plants. The foundation course introduced for the MSc students provides basics of all the biological sciences and chemistry subjects, in addition to the biotechnology related subjects. The post-graduate students get placed in all the top ranked research institutes in India such as IISc, CCMB, CDFD, ICGEB, IGIB, and NII. The department prides in its fully equipped and dedicated laboratory facilities. The laboratories and class rooms are centrally air conditioned. The faculty members of the department have been able to attract a large number of extramural funded research projects. At present the department has 18 ongoing research projects sponsored by DST, DBT, DRDO, AYUSH, CCRUM, CSIR, and ICMR. Since June 2000, close to 432 papers have been published in the international journals by the department. The nutrient management technology developed in the department for higher Artemisinin yield and 1000 tissue culture raised seedlings of Artemisia annua L. were transferred to Ipca Laboratories, Mumbai, in a consultancy program at an amount of 6 lakh. A novel protein isolated from the outer membranes of S. typhi has been transferred to Oscar Medicare for evaluation as a diagnostic probe for typhoid for a token consultancy of 19,500. Based on its performance and potential, the department has been selected by UGC for a special assistance program (SAP) grant. A sum of 50 lakh has been awarded for purchase of equipment under SAP. This is in addition to the grant for the routine equipments from the university. Fact file | Name of the Department: Department of Biotechnology Courses: MSc and PhD in Molecular Biology and Biotechnology Coordinator: Dr S K Jain Website: www.jamiahamdard.edu/biocenter.asp "While majority of the biotechnology programs in various universities are either plant biotechnology based or animal/microbial biotechnology based, the biotechnology program in Jamia Hamdard is one of the very few programs where equal emphasis is given to both plant and animal/ microbial biotechnology. The students here are therefore better equipped and ready to take challenges in both these fields" Dr S K Jain department of biotechnology, Jamia Hamdard ]]> <![CDATA[9-Tezpur University, Sonitpur]]> https://biospectrumindia.com/news/95/2928/9-tezpur-university-sonitpur.html https://biospectrumindia.com/news/95/2928/9-tezpur-university-sonitpur.html Thu, 16 Aug 2012 19:55:00 +0530 Developing skilled workforce Besides improving research infrastructure, the department is involved in training its students for higher research prospects The department of molecular biology and biotechnology (MBBT) at Tezpur University was established in 1997. Since then, it has been recognized and granted accreditation for the post-graduate program by the Department of Biotechnology (DBT), Government of India. The department offers two-year MSc degree in molecular biology and biotechnology, five-year integrated MSc in bioscience and bioinformatics and PhD in molecular biology and biotechnology. Out of 427 applications received by the department in 2011-12, 10 students were admitted for the seats reserved for north-east quota. Out of the 28 seats for normal category, 14 were filled through All India Examination conducted by JNU and the rest were filled by GATE/ICR NET/ ICAR JEE examinations. While 42 percent of the students are from rural background, rest 58 percent belong to urban area. The faculty members have been able to attract large research grants in the year 2011 and have been awarded DBT Overseas Associateship and DBT Crest Fellowships. A departmental library and DBT supported bioinformatics facility support the teaching and research programs of the department. Since 2008, the department has utilized 18.50 crore provided by various government agencies and completed 1.70 crore worth industry sponsored projects. Access to journals and e-resources is also provided by different consortia such as UGC-Infonet consortium (providing access to 7,500 journals and 11 databases). Most of the passed out MSc and PhD students from the department are pursuing higher studies (doctoral and post-doctoral research, respectively) in some of the premiere research universities in the country and abroad. Since June 2000, the department has published 26 research papers in national journals and 90 research papers in international journals. Between 2007-2010, the department has developed two biotech related products that were subsequently transferred to the industry. It has also filed four national and two international biotech related patents. Fact file | Name of the Department: Department of Molecular Biology and Biotechnology Courses: MSc, 5 years integrated MSc and PhD in Molecular Biology and Biotechnology Coordinator: Prof. Shashi Baruah Website: www.tezu.ernet.in/dmbbt "Most of our alumni are pursuing doctoral and post-doctoral research in premiere research universities in the country and abroad. In addition, many students have secured jobs in R&D sectors of the industry and as scientists, and faculty members in many reputed universities and colleges of the country" Prof. Shashi Barua professor & head, department of molecular biology and biotechnology (MBBT), Tezpur University ]]> <![CDATA[8-National Dairy Research Institute, Karnal]]> https://biospectrumindia.com/news/95/2327/8-national-dairy-research-institute-karnal.html https://biospectrumindia.com/news/95/2327/8-national-dairy-research-institute-karnal.html Thu, 16 Aug 2012 19:54:00 +0530 Focused on quality animal biotechnology research Animal Biotechnology Centre at NDRI has been producing quality students with exposure to proven high-end embryonic research In 1987, on recommendation of the National Task Force of the Department of Biotechnology (DBT), Government of India, a national project on embryo transfer technology (ETT) was initiated at National Dairy Research Institute (NDRI) which was also supported by ICAR/USAID bilateral co-operation in its initial stages. This formed the basis of establishment of a state-of-the-art Embryo Biotechnology Centre at NDRI. Besides the masters course in animal biotechnology, the center also offers PhD course in animal biotechnology. During the academic year 2011-12, 11 students were admitted in the MSc course through the All India Entrance Test conducted by Indian Council of Agricultural Research (ICAR), New Delhi. The center has 12 well-experienced faculty members who have undergone training in some of the most advanced laboratories in the world. Over the years, the center has developed impressive facilities for research and teaching in the areas of embryo technologies, tissue culture, genome analysis, expression genomics, and proteomics. 22 biotech-related papers have been published in the national journals since 2000 and there are 93 publications in international journals. A new state-of-the-art laboratory facility is being constructed with more than 20,000 square feet of lab space consisting of core laboratories on various aspects of dairy production and processing related biotechnology research such as prokaryotic and eukaryotic genomics, animal tissue culture, fermentation technology, transgenic animal production and other supporting labs. The center is currently involved in conducting research on areas of high-end embryo techniques Recognizing its strength in genomics research, the center has been included in the buffalo gene mapping initiative of DBT and niche area of research on buffalo production and reproduction genomics by ICAR. Under animal genomics research, the center is working on characterization, mapping and QTL identification for useful economic traits in buffalo and understanding the gene expression regulation of IVM and IVF event in buffalo. The ongoing research projects are being funded by ICAR and several other national and international funding agencies. Fact file | Name of the Department: Animal Biotechnology Center Courses: MSc and PhD in Animal Biotechnology Coordinator: Dr R S Manik Website: www.ndri.res.in "The Animal Biotechnology center is an advanced research center where we have a large number of externally funded research projects" Dr R S Manik principal scientist, animal biotechnology centre, NDRI ]]> <![CDATA[6-Guru Gobind Singh Indraprastha University, New Delhi]]> https://biospectrumindia.com/news/95/1881/6-guru-gobind-singh-indraprastha-university-new-delhi.html https://biospectrumindia.com/news/95/1881/6-guru-gobind-singh-indraprastha-university-new-delhi.html Thu, 16 Aug 2012 19:50:00 +0530 Creating industry-ready students Having devised a unique curriculum, USBT provides research and education based on national values, social awareness Founded in 1999, the University School of Biotechnology (USBT) at Guru Gobind Singh Indraprastha University, offers BTech and MTech course in biotechnology under dual degree program. In the year 2011-12, 20 students were admitted to the MTech and 58 to BTech courses. The admission to the programs is done strictly on the basis of merit adjudged through an All India Common Entrance Test. At present 14 students are pursuing research in the school under the guidance of the faculty members. The university has shifted from its Kashmere Gate campus to the new state-of-the-art 60-acre campus in Dwarka where new GLP compliant labs are being built to attract from the industry funding. The school has 14 faculty members with expertise in diverse areas of modern biology and biotechnology. The faculties also have collaborations with scientists in India and abroad, and as a result the school has a publication record of over 322 biotech related research papers in the international journals and 192 papers in the national journals in the last seven years. The laboratories are equipped with the latest equipment costing over 4 crore. Total value of new government agencies undertaking sponsored projects commissioned between 2007 and 2012 is 10 crore. The school has 3 crore as extramural funds with projects running in collaboration with DBT, DST, DRDO, AICTE, and UGC. The school also plans to actively pursue projects and collaborative programs in plant, animal and microbial functional genomics, stem cell biology and industrial biotechnology in the future. The alumni of the biotech department have carved a place for themselves in prestigious institutes in India and abroad including University of Illinois, Ohio State University, Tufts University, Pennsylvania State University, North Carolina State University, University of Cambridge, IIT Madras and IIT Bombay. Fact file | Name of the Department: University School of Biotechnology Courses: BTech, MTech and PhD in Biotechnology Coordinator: Prof. Rajinder K Gupta Website: www.ggsipu.nic.in "Our focus is on creating a high value degree and students who are employable by the industry. But the truth is that in the present scenario, the Indian biotech industry has not grown that big so that it can absorb all the students. About 30% of the our BTech pass out students opt to go abroad for MSc/PhD. About 20% opt to join MBA course" Prof. Rajinder K Gupta dean, University School of Biotechnology ]]> <![CDATA[5-University of Hyderabad, Hyderabad]]> https://biospectrumindia.com/news/95/1395/5-university-of-hyderabad-hyderabad.html https://biospectrumindia.com/news/95/1395/5-university-of-hyderabad-hyderabad.html Thu, 16 Aug 2012 19:49:00 +0530 Focused on molecular therapeutics A host of industry and government sponsored projects foster a research-centric environment at University of Hyderabad The department of biotechnology at University of Hyderabad's school of life sciences establishes itself in the fifth position this year. The popularity of the university is visible from the high volume of applications received for the limited seats in each of its courses. This is especially evident by the 968 applications received for the 18 seats allotted for a PhD in biotechnology. The school of life sciences is considered to be among the top two preferred choices for students applying through the JNU entrance exam for higher studies. Special provisions are made for the final year projects of students such that just two MSc students can work in each lab. Most of the students prefer to continue their higher studies after obtaining their master's degrees. It has tie-ups with several foreign universities in Germany and Malaysia providing better opportunities for students interested in pursuing their PhDs. An attractive feature of the school is that of the comparatively affordable fee structure in place for the biotechnology courses. All the faculty employed at the school of life sciences are PhDs with more than half of them having more than five years of experience. The university had over eight visiting faculty for the academic year. In-house research carried out by professors and students has seen the university apply for three Indian patents. It is also one of the few universities in India to have a high number of scientific publications, in India and abroad. It has over 110 publications since 2008. The industry interaction is enhanced by the industry sponsored projects worth 20 lakh since 2008. These projects are from companies like Stempeutics and Heterodrugs. Government sponsored projects from DBT, DST, ICMR and CSIR are valued at 4 crore during the last four years. The total cash inflow from royalties and license fee generated 198 lakh from 2009-12. The University saw companies such as Dr. Reddy's Labs and Shantha Biotech come to its campus for placements in 2011 -12. Fact file | Name of the Department: Department of Biotechnology, School of Life Sciences Courses: MSc in Biotechnology, Animal biotechnology, Plant Biotechnology, Medical Biotechnology; MTech in Bioinformatics, Integrated; MSc PhD program and PhD in Biotechnology Coordinator: Prof. P Prakash Babu Website: www.uohyd.ac.in "The quality of education is of very high standard and we receive a wide variety of students from all over India, giving a very cosmopolitan flavor to the college. Also the lab training offered to the students is much more advanced than in any other college" Prof. P Prakash Babu head, department of biotechnology ]]> <![CDATA[3-Institute of Chemical Technology, Mumbai]]> https://biospectrumindia.com/news/95/1094/3-institute-of-chemical-technology-mumbai.html https://biospectrumindia.com/news/95/1094/3-institute-of-chemical-technology-mumbai.html Thu, 16 Aug 2012 19:48:00 +0530 Center of excellence for bioresearch With every passing year, ICT is scaling newer heights in the areas of applied chemical sciences and biotechnology The Institute of Chemical Technology (ICT) offers training and research in the field of chemical engineering, chemical technology and pharmacy. ICT has emerged as a major center for development of applied chemical sciences. A 2011 annual survey on the research standards of engineering and technology institutes, conducted by the Georgia Institute of Technology, USA, ranked ICT as number one in India and number four in the world. During 2011-12, a total of 30 students were enrolled for the MTech course in bioprocess technology out of 323 applications received for admission and 10 students enrolled for the MTech course in food technology out of 101 applications received. Currently there are 20 students pursuing their PhD courses in bioprocess technology and food technology. There are a total of 34 full-time faculty members dedicated to biotechnology. Between June 1, 2007 and May 31, 2011, ICT saw a total of 77 research papers published in national journals, and 667 papers published in international journals. Since 2003, around 25 international patents and three national patents have been filed. A total of 24 labs are dedicated to biotech students with a capacity to accommodate 10 students per lab. About seven students opted to do PhD at ICT and 15 students got job placements through campus interviews with nine companies coming to the campus. ICT has 22 MoUs with foreign universities in countries such as the USA, the UK, Canada, Australia, and New Zealand. As a front runner of the Indo-US biofuels program, the DBT-ICT Centre of Energy Biosciences is India's first national bioenergy research center. Set up at an initial cost of 24.8 crore, it is a multidisciplinary center with emphasis on cutting-edge technology. The center now will be focusing on algae biotechnology. A budget of 70-80 crore has been allocated to set up a dedicated department of biotechnology. The process of infrastructure building has commenced and is expected to be completed in the next two years. A total of 60 students would be enrolled for this department. Fact file | Courses: MSc, MTech and PhD Head: Prof. G D Yadav Website: www.ictmumbai.edu.in "Our outstanding infrastructure along with a research oriented syllabus is what differentiates our institute from others. Most of our faculty act as consultants to various companies and hence are in tune with what the industry wants" Prof. G D Yadav vice chancellor, ICT ]]> <![CDATA[2-Rajiv Gandhi Centre for Biotechnology, Thiruvananthapuram]]> https://biospectrumindia.com/news/95/1883/2-rajiv-gandhi-centre-for-biotechnology-thiruvananthapuram.html https://biospectrumindia.com/news/95/1883/2-rajiv-gandhi-centre-for-biotechnology-thiruvananthapuram.html Thu, 16 Aug 2012 19:43:00 +0530 Growing on international collaborations A plethora of government sponsored projects allows students to gain rich and valuable hands on research experience Rajiv Gandhi Centre for Biotechnology (RGCB) is an autonomous national research institution under the DBT and affiliated to the University of Kerala. The admission for the PhD program is through various national level entrance exams conducted by CSIR, DBT, and ICMR. RGCB saw 34 students getting admitted over the last academic year. It remains to date as one of the very few institutions with experienced faculty, with 90 percent of its teaching staff possessing a PhD and have several decades of experience. The research conducted at RGCB can be substantiated by the high number of papers published in international publications, which is 226. The institution has filed for 11 Indian patents and four international patents since 2008. RGCB has two major public service facilities, a regional facility for DNA fingerprinting and molecular diagnostics. The institute is also planning to start a MSc course in molecular diagnostics. This initiative in the future can complement its existing molecular diagnostics lab. Since June 2009, RGCB has had government sponsored projects worth 15 crore and industry sponsored projects worth 4 crore. In addition to the government sponsored research, faculty members also avail the intramural funding made available to them by the institution. RGCB also houses an incubator in its campus, which is jointly run by HLL Lifecare for the development of better diagnostics for infectious diseases. The lab to student ratio is very high at RGCB with over 40 labs dedicated to biotech students with an occupancy of only ten students per lab. The students after completing their PhD, pursue post-doctoral fellowship. RGCB has a host of joint programs with the George Washington University for a PhD program in cancer research. Another collaboration with Oklahoma Medical Research Foundation is in place for the training of post-doctoral fellowships. RGCB recently acquired 20 acres of land from the government for the expansion of its campus, which will later house an interdisciplinary innovation centre for the research and development of novel vaccines. Fact file | Name of the Department: School of Biotechnology Courses: PhD in Molecular Biology and Biotechnology Director: Prof. M Radhakrishna Pillai Website: www.rgcb.res.in "Our very strong disease biology program that focuses on animal, human as well as plant diseases is what differentiates us from other institutions" Prof. M Radhakrishna Pillai director, school of biotechnology, Rajiv Gandhi centre for Biotechnology ]]> <![CDATA[â€œUrgent need for redefining IPR strategyâ€?]]> https://biospectrumindia.com/news/95/5872/urgent-need-for-redefining-ipr-strategy.html https://biospectrumindia.com/news/95/5872/urgent-need-for-redefining-ipr-strategy.html Thu, 16 Aug 2012 19:11:00 +0530 â€œIndia stands one among the top 10 league of countries in the Global Innovation Efficiency Index which shows the countries that are best in transforming the given innovation inputs into innovation outputs,â€? said Chaitanya Prasad, controller general of patents, designs and trade marks, Government of India, while quoting the latest report -Global Innovation Index 2012. Speaking on 'IP rights ecosystem in India' at the 5th Annual Innovation and Intellectual Property Symposium organized by GE India Technology Center, Bangalore, in collaboration with the Associated Chambers of Commerce and Industry of India (ASSOCHAM), Chaitanya said that in India, over 75 percent of the patents are filed by foreign applicants and rest by the local applicants. Hence there is a need for large scale awareness campaigns, education on commercialization of IP and focus on patent protection. The symposium focused on the evolution of the Indian innovation ecosystem and addressed the challenges in the current IP ecosystem in India. The symposium provided a platform for industry experts to discuss about the next steps that can be taken to strengthen and encourage innovation at all levels. During his speech on the concept of the 'National IPR Strategy', Hemant Singh, chairman, IPR Council of ASSOCHAM India said, â€œThe growth rate of patent filings in India has increased by five percent since 2005. However, with India being one of the fastest growing innovation hubs of the world, we have innumerable opportunities for us to tap.â€? Himalaya launches HiOwna-Jr. for kids The Himalaya Drug Company recently launched HiOwna-Jr., a prescription-based nutritional supplement for kids, that promotes physical and mental growth. Marking its entry into the $1.5 billion nutraceuticals market in India, this is first of Himalaya's products to be launched. HiOwna-Jr is mainly directed towards urban families with kids who are fussy eaters. The supplement contains 13 essential vitamins and nine minerals. Keeping in line with Himalaya's product philosophy, it contains Ayurvedic ingredients such as Ragi (finger millet), that improves nutritive status; Maricha (black pepper), a bio-availability enhancer; Mandukaparni (centella), a cerebral activator; and Amalaki (Indian Gooseberry), an immunity enhancer. The supplement will also be the first in India to be introduced with pea protein. In order to make the supplement more attractive towards its target population, HiOwna-Jr. has been launched in two flavors-strawberry and chocolate. GLS research facility gets DSIR recognition Chennai-based bioinformatics and biomarker company, Genome Life Sciences (GLS) recently received recognition for its in-house R&D facility from the Department Of Scientific and Industrial Research (DSIR) under the Ministry of Science and Technology, Government of India, New Delhi. This recognition speaks of Genome Life Science's excellent track record of world class research and technology development in the areas of next generation biomarker research using its patented technology, Functional Genomic Fingerprinting (FGF) and also into bioinformatics product development. According to Dr Narinder Singh, head, technology innovation and commercializing research, GLS, â€œIn a country like India, where bioinformatics and biomarker research is in infancy stage, this recognition is a boost to Genome Life Science to promote further research in biomarker and bioinformatics and collaborate with other national and international institutions of excellence.â€? GLS' R&D facility is to address the speedier development of next generation biomarkers using FGF printing technology from various sources and evolve clinically meaningful research outputs, diagnostic product development and plant molecular marker for rapid crop breeding programs. The company is in advanced stages of license agreement and knowledge-sharing tie-up with various MNCs in pharma and agri-biotechnology companies, which will give them access to GLS' expertise and technology in biomarker research programs. Cellworks, AstraZeneca join in TB deal In a bid to accelerate TB research, AstraZeneca and Cellworks have announced a collaboration, creation of platforms and approaches to handle multi drug resistant Tuberculosis (MDR-TB). This collaboration, supported by the Wellcome Trust, will aim to speed the design of novel combination therapies for the treatment of drug-sensitive and resistant tuberculosis. Bangalore-based Cellworks is a private, venture-backed biopharmaceutical therapeutic design and development company. Cellworks will use its proprietary predictive platform, which it pioneered in oncology and autoimmune disorders, to model drug MDR-TB and rationally identify 'synergistic combinations' that might have the highest efficacy and lowest possible toxic burden compared to all currently available combinations. AstraZeneca will then validate the top ten most effective combinations identified by Cellworks in-vitro in its laboratories, followed by validation using in-vivo model. Both Dr Anand Anandkumar, MD, Cellworks Group India and Dr Manos Perros, head, infection innovative medicines unit, AstraZeneca expressed their confidence about the collaboration. Venus introduces Taxedol in India The Chandigarh-based global pharmaceutical company, Venus Remedies has introduced for the first time a nanotechnology based â€œReady-to-Useâ€? Single Vial Docetaxel in the domestic market under the brand name â€œTAXEDOL.â€? Commenting on this, Dr Mufti Suhail Sayeed, vice president Venus Medicine Research Center (VMRC) said, â€œTAXEDOL is ready-to-use single vial formulation available in three strengths 20mg/0.5 ml, 80mg/2 ml, and 120mg/3ml. Our one-vial formulation and is having the advantage of requiring a single dilution step in suitable infusion solutions prior to administration. Thus, offering cost-effective solution to patients.â€? As per Venus Remedies, the research at VMRC has established that, this novel technology is unique and will offer significant therapeutic advantage over all available similar and competing products. TAXEDOL is a single unit stable, pharmaceutical formulation which has lesser impurities in comparison to innovator product. This one vial formulation of Docetaxel will not only make the administration of the drug easier by introducing the premix solution but at the same time will provide enhanced safety to patients and para-medical staff. Furthermore, the nano-scale size of the formulation results in improved penetration, higher efficacy, improved safety and lesser side effects. The formulation comprises of Docetaxel in nano particle form which gives 11 percent higher cancer cell killing potential as compared to existing Docetaxel. A semi-synthetic analogue, Docetaxel is considered to be one of the most effective and successful oncology product in the cancer treatment. Serum Institute acquires Dutch biologics company Serum Institute of India (SII) the flagship company of the over $1 billion Poonawalla Group and India's largest vaccine company, has acquired Bilthoven Biologicals of Netherlands. Through the acquisition, Serum Institute will get access to technology and expertise for making the injectable polio vaccine (Salk), a unique capability and expertise that is currently possessed by a mere three other vaccine manufacturing plants globally. This first overseas acquisition by the Poonawalla Group will also provide the Group and Serum Institute, an important manufacturing base in Europe, with access to the important European and the US markets. SII had business dealings with Bilthoven Biologicals for the last 35 years, which was owned by the Netherland government. Serum Institute of India is one of world's leading vaccine manufacturers, and according the the BioSpectrum Top 20 Survey 2012, it is India's leading biotech company with revenues surpassing 1,708 crore. Its range of products have been used in 140 countries across the globe. It is estimated that two out of every three children immunized in the world is vaccinated by a vaccine manufactured by SII. Currently its headquarters along with its manufacturing facility is located near Serum Bio Pharma Park, India's first biotech special economic zone (SEZ) at Pune. Bilthoven Biologicals now positions itself as a contract manufacturer and expects to profit from the new ownership. ]]> <![CDATA[SME Exchanges: Big change for Biotech?]]> https://biospectrumindia.com/news/95/2946/sme-exchanges-big-change-for-biotech.html https://biospectrumindia.com/news/95/2946/sme-exchanges-big-change-for-biotech.html Thu, 16 Aug 2012 19:06:00 +0530 National Stock Exchange and Bombay Stock Exchange, in March 2012 launched their seperate platforms for SMEs. This step could prove to be a game changer for healthcare and biotech sectors For an industry that is capital intensive in its initial years of operation, raising the required amount of funds has always been a challenge for India's biotech companies. Getting listed on the stock exchange, considered to be the preferred route to raise capital for most technology and retail companies, has not been an option heavily exercised by the biotech industry. The recent launch of the small and medium enterprises (SME) exchanges by the country's leading stock exchanges, however, could prove to be a game changer for the small and medium sized industries in healthcare and biotech. India's leading bourses, National Stock Exchange and Bombay Stock Exchange launched their separate platforms for SMEs - Emerge and BSESME respectively on March 13, 2012. This was a long awaited launch considering the fact that the Securities and Exchange Board of India (SEBI) laid down the framework for such a trading platform in 2008 and announced detailed guidelines in May 2011. Both the exchanges are going to run based on these guidelines. Since their start, both Emerge and BSESME have had one company each listed on their platforms. With the launch of such an exchange, India joins the league of other countries such as the UK (Alternate Investment Market or AIM), China (Chinex), Hong Kong (Growth Enterprise Market or GEM) and Japan (Market of the high-growth and emerging stocks or MOTHERS) with similar exchanges. Termed to be drivers for today's entrepreneur driven economy, SMEs are said to contribute 40 percent of exports employing over 60 million people according to the SME Chamber of India. For a group that contributes over 17 percent of the GDP, adequate support from the government is rightfully warranted. Hence in the latest budget, a corpus of 5,000 crore has been allocated for the Small Industries Development Bank of India (SIDBI). Industry experts hope that a significant portion of this is reserved for the healthcare sector. The need for the exchange rose primarily from the want of good visibility for smaller companies. A point highlighted by Ravi Tyagi, head, Emerge, NSE Exchange, â€œThe big difference between the main board and a platform like this is that, the former has a large number of companies that are mature with around 1,00,000 investors and here small companies tend to get lost. At such an SME exchange the issues are smaller. Also there is a higher risk and more uncertainty. However the people who invest in such companies are generally those who are well informed and resourceful and who are interested in investing in such fast growing companies.â€? What it means for biotech... The growth of the biotech industry though replete with expectations a decade ago, did not translate into a lot of initial public offerings (IPOs) for a number of reasons. In fact barring a few companies such as Biocon, Camson Biotech, Suven Life Sciences, Transgene biotek, and Zydus Cadila are very few biotech companies have gone the IPO way to raise money. â€œBiotech companies in India have failed to scale up and get to a size where they can be potentially listed and attract capital market attention,â€? says Nitin Deshmukh, CEO, private equity, Kotak Investment Advisors. Deshmukh adds, â€œThere was a lot of build up that happened post the Biocon listing in 2004, but that momentum was lost. That is why capital markets and investment bankers have not been very receptive to this industry. There are very few investment banks who are investing in this sector.â€? The ability to sustain growth throughout has been vital for the success of any company to have a successful fund raising experience at the stock markets. Dhirendra Kumar, founder and CMD, Camson Biotech tells about his experience of getting listed on the main exchanges, â€œFor a company such as ours, we had very few options for private equity funding. Not many wanted to invest in research and development. There was a huge difference in our revenues after getting listed. We opened for trade at 180 per share of 10 in 2008 at BSE. Today raising funds is not a serious issue anymore. Also, since bioagri is not very equipment intensive compared to other sectors, scaling up is not as difficult.â€? Apart from the access to public equity which is a boon during the growth phase of any company, a popular opinion is that getting listed on a stock exchange offers a sense of visibility along with enhancing the transparency in a company's operations. This would not only attract investors but also build a trust quotient with external government agencies and other private funds, an added advantage to the biotech companies. The fine print The most essential criteria for selection of the companies for both Emerge and BSESME is based on the underlying principle that the post issue paid-up capital is to be less than 25 crore. This differentiates it from the general definition of the MSME industry which states that, an SME is one where the investment in equipment or production plant does not exceed Rs10 crore. This allows for the participation of a large number of companies from all sectors making the option available to many entrepreneurs. Tyagi seconds that by noting, â€œThe number of people who are already listed in NSE and are eligible for getting listed on Emerge is quite high and the current regulations in place allow for the transfer of these firms between the exchanges.â€? Tyagi also added that a lot of companies in the healthcare and pharma industry have already expressed interest in Emerge. Another salient feature is that the company should be cash positive for two years as opposed to three years on the main board. However, owing to the long research timelines of most biotech companies, a lot of them find it difficult to show such results, proving it to be a major impediment. However, Tyagi says, â€œExceptions can be made in a few cases if the company can show good credibility and have a good ecosystem and that can validate its work.â€? Contrary to the main exchanges, the SME platforms have different requirements for the merchant bankers. Tanika Singh, associate at Amarchand and Mangaldas and Suresh A Shroff and Company, a legal firm, further explains, â€œA nominated investor (NI) is a qualified institutional investor or private equity fund, who subscribes to the issue in case of under-subscription or assists in the market making process. The role of NIs is especially relevant as other investors could potentially place reliance on NI's participation in making their investment decision. The other is that of market-making which has been made mandatory for a minimum period of three years. The NI concept has been introduced to reinforce the role of the merchant bankers, especially in the context of compulsory market-making.â€? The relative inexperience of most companies entering into such a platform would require a degree of handholding for sometime. Singh adds, â€œKeeping in mind the success of the AIM framework and that the Indian SME, exchanges are currently in their pilot stage, the SME Listing Framework might significantly benefit from the introduction of a similar roster of advisers registered with the exchanges, who can assist with unknown compliance requirements and standards.â€? Apart from this, some other changes have also been incorporated in order to further aid the companies, such as the submission of financial results on a half yearly basis instead of quarterly, the choice of making available the results on the website instead of publishing them and sending in only the salient features to the shareholder. A point strongly favored by investors are the exit options available after the listing in an exchange. Kumar, who said that Camson Biotech would also be interested in moving to an SME platform in future, further reiterated, â€œPeople who put in money as an investment should have an exit route. Getting listed gives us that liberty.â€? The road ahead This however would not be the first attempt in India for such an exchange. The Over-the-Counter Exchange of India (OTCEI) in the mid 90s was a similar initiative, which later suffered from the lack of investor interest. The lessons learned from that experience need to be remembered in order to ensure the success of these new exchanges. Also a new round of discussion is needed after a year of the operations to assess the progress and implement any additional features if need be. Only time will tell the success of this initiative and the impact it can have, meanwhile the biotech industry has welcomed it. It has definitely set the ball in motion for medium sized companies to access public funds for their growth. Though, surely not a sure shot solution for all problems related to capital, the exchanges do present a promising opportunity to the companies in an environment starved of venture capitalists willing to invest in early and mid stage firms in life sciences industry. Key differences between Emerge and Main Board Particulars Emerge Main Board IPO Track record Track record of atleast three years, positive cash accruals (EBDT) from operations for atleast two financial years and positive net-worth* Three years track record of profitability IPO grading Not mandatory Mandatory Post-issue paid-up capital (Face Value) Less than 25 crore Not less than 10 crore Minimum number of allottees in the IPO 50 1000 Observations on DRHP By the Exchange By SEBI IPO underwriting 100% underwritten (15% on the books of the merchant banker) Mandatory (Not required where 50% of issue offered for compulsory subscription by QIBs) Market capitalization/Issue size No restriction No restriction IPO application size Not less than 1 lakh 5,000 - 7,000 Post-issue Reporting requirements (Audited accounts) Half-yearly Quarterly Market making Mandatory Not mandatory Corporate government requirements Same as main board Clause 49 *Exchange requirements Courtesy: NSE Manasi Vaidya ]]> <![CDATA[Waters celebrates 25 years in India]]> https://biospectrumindia.com/news/95/2118/waters-celebrates-25-years-in-india.html https://biospectrumindia.com/news/95/2118/waters-celebrates-25-years-in-india.html Tue, 17 Jul 2012 11:54:00 +0530 Waters India, a fully owned subsidiary of Waters Corporation in the USA, is celebrating its silver jubilee anniversary of its successful operations in India. Driven by a long-term commitment to the region, Waters had the vision 25 years ago to invest in India as the first analytical science company to incorporate in the country by creating a joint venture with local partners in 1988. â€œWhat attracted us 25 years ago to India is the same thing that motivates us today; we continue to welcome the opportunity to work with and contribute to one of the most exciting economies in world,â€? said Mr Art Caputo, president of the Waters Division. Understanding scientific challenges through cooperation, Waters' strategy is to invest in local service and support, and to focus on partnerships tailored to meet the needs of India's leading organizations. Waters consistently invests in Waters India to create the best infrastructure including world-class application and demonstration laboratories. Waters India is currently expanding its headquarter facility in Bangalore. Throughout the country, Waters partners with pharmaceutical companies, contract research organizations and government agencies with the goal of expanding research capabilities, increasing laboratory efficiency, and navigating complex regulatory compliance requirements worldwide. Examples of recent partnerships include Dr. Reddy's Laboratories, Lambda Therapeutic Research, the Marine and Agricultural Product Export Development Agency and the India Environmental Protection Agency. Waters is marking the 25th anniversary of the start of business operations in India, with the initiation of online ordering through a new order center. Waters is introducing several new features designed to facilitate ordering and lower transaction costs by including the posting of real-time product availability, local currency pricing, available discounts, order tracking, and special offers. Automated 3D cell culture solutions Reinnervate and Tecan Trading, have signed a co-marketing agreement to develop a range of automated solutions for 3D cell culture, based on the Freedom EVO liquid handling workstations and Reinnervate's Alvetex Scaffold 3D cell culturing technology. Alvetex products are based on a highly porous, polystyrene scaffold structure with a uniform and well-defined architecture that provides an excellent environment for cells to acquire and maintain their natural 3D shape and organization during incubation. The Alvetex Scaffold technology therefore gives more biologically relevant data by overcoming the limitations of traditional monolayer cultures. In combination with the flexibility and reliability of the Freedom EVO platform, it will provide powerful solutions for automated growth and maintenance of 3D cell cultures. Agilent expands HaloPlex target enrichment Agilent Technologies expanded the HaloPlex target enrichment system, which will now be available on Ion Torrent's Personal Genome Machine, a benchtop sequencing solution. The HaloPlex system features a unique paired-end design, which positions reads at both target ends using a single-end sequencing run. By taking advantage of the extra coverage that the paired-end design provides, researchers will be able to save sequencing costs and time. HaloPlex continues to break barriers common to other target enrichment technologies and can now enable larger capture sizes during desktop sequencing â€“ up to 5Mb or approximately 2,000 genes on a MiSeq personal sequencer. HaloPlex offers greater efficiency and improved performance, and it allows researchers to process up to 250,000 amplicons in the same tube. The HaloPlex system's fast-scaling target enrichment technology demonstrates Agilent's ongoing commitment to enabling a better research workflow regardless of the sequencer platform being used. HaloPlex is a flexible and customizable product that enables users to create designs in less than 10 minutes to enrich thousands of genomic targets, using the no-charge Web Design Wizard. Agilent acquired Halo Genomics of Uppsala, Sweden, and the HaloPlex platform in December, 2011. HaloPlex technology complements the existing Agilent SureSelect target-enrichment system. ]]> <![CDATA[BHU to open center for stem cell research]]> https://biospectrumindia.com/news/95/1948/bhu-to-open-center-for-stem-cell-research.html https://biospectrumindia.com/news/95/1948/bhu-to-open-center-for-stem-cell-research.html Tue, 17 Jul 2012 11:50:00 +0530 Banaras Hindu University (BHU) is all set to establish a first-of-its-kind stemcell Research & Bone Marrow Transplatation Center in Uttar Pradesh, which will facilitate research on both stem cells and bone marrow transplants. The center is expected to open new avenues of treatment for life-threatening ailments such as cancer, cardiovascular and auto-immune disease in the state. To be ready in another one and a half years, the center is coming up at the cost of 20 crore while the equipment will be worth 40 crore approximately. There are not many centers in the country that carry out such stem cell research. In Uttar Pradesh, though there is sporadic research going on, no such organized state-of-the-art facility is available. After Hyderabad and Mumbai, Varanasi will be the third such city to host a center meant for inter-disciplinary research for development of new technology in stem cells. It will be a centralized facility where researchers from other life sciences departments as well as from Indian Institute of Technology-BHU will be able to carry out research. The center will be a ten-bed facility for patients who undergo stem cell as well as bone marrow transplant. So far in the state only Sanjay Gandhi Post Graduate Institute of Medical Sciences (SGPGIMS), Lucknow, offers bone marrow transplant. Technology to curb fake drugs Gurgaon-based PharmaSecure India has developed mobile authentication technology that empowers the end consumer to check and authenticate their own medicine by SMS, voice or web at mobile number 99010 99010. According to the company, each medicine package that is coded has a unique, randomly generated alphanumeric code printed directly on the package. When a consumer sends this code by SMS, a message comes back verifying the medicine is genuine. The global anti-counterfeit packaging market is expected to be worth $79.3 billion by 2014, growing at an estimated CAGR of 8.6 percent from 2009-14. India is one of the world's leading producers of drugs, but it faces a huge threat by the circulation of spurious medicines being produced by the counterfeit mafia. â€œMobile authentication has high relevance in a country such as India, because it has leapfrogged the landline culture and the mobile has become the way of life. The ease of usage is another advantage in popularizing the concept and its benefits,â€? adds Mr Nathan Sigworth, founder and CEO, PharmaSecure. Dr. Reddy's, Merck to develop biosimilars Dr. Reddy's Laboratories and Merck Serono, a division of Merck KGaA, announced a partnership to co-develop a portfolio of biosimilar compounds in oncology, primarily focused on monoclonal antibodies (mAbs). The partnership covers co-development, manufacturing and commercialization of the compounds around the globe, with some specific country exceptions. Dr. Reddy's has been a pioneer and leader in the biosimilars space through proven product development capabilities and the launch of four biosimilars molecules to date. The partnership with Merck Serono expands on Dr. Reddy's presence in the biosimilar space in select emerging markets and enables participation globally. The deal structure calls for Merck Serono and Dr. Reddy's to co-develop the molecules included in the agreement. Dr. Reddy's will lead early product development and complete phase I development. Upon completion of phase I, Merck Serono will take over manufacturing of the compounds and will lead phase III development. The agreement is based on full R&D cost sharing. Merck Serono will undertake commercialization globally, outside the US and with the exception of select emerging markets which will be co-exclusive or where Dr. Reddy's maintains exclusive rights. Dr. Reddy's will receive royalty payments from Merck Serono upon commercialization. In the US, the parties will co-commercialize the products on a profit-sharing basis. Abbott, Syngene opens nutrition center Dr Sam Pitroda, advisor to the prime minister of India on Public Information Infrastructure and Innovations and Chairman of the National Innovation Council, inaugurated Abbott's first nutrition research and development (R&D) center in the country. This center is in collaboration with Syngene and is located at the Biocon Park in Bangalore. The new R&D center will focus on the development of nutrition products for maternal and child nutrition and diabetes care. Among the products being developed for the Indian market are meal complements for diabetics and pre-diabetics. In addition, the center will address local taste and texture preferences with new flavors and formulations. The state-of-the-art R&D center hopes to enable the expansion of Abbott's nutrition product portfolio. The facility will house a range of integrated capabilities including product development and analytical laboratories as well as a dedicated laboratory for analyzing flavor, sensory elements and packaging. The analytical lab will be equipped with technology for a broad spectrum of nutritional analysis ranging from micronutrient to microbiological testing. Bigtec to launch mini PCR this year Bigtec's mini PCR, TrueLab is a point-of-care, hand-held, real time quantitative mini PCR, that is battery operated. This device detects the disease organism by a polymerase chain reaction (PCR) carried out on a chip that is designed using Microelectromechanical systems (MEMS) technology and is specific to each disease. Simple to operate, its design is such that a primary healthcare worker can easily use it during field visits as well. The patient sample is fed onto the chip that is entered into the device. The results are obtained in the form of a simple readout on the screen and can be connected to a printer as well. The instrument is also bluetooth enabled. An important differentiating factor with TrueLab, is the fact that unlike conventional PCRs only one sample at a time can be processed. This has been done on purpose, Mr Chandrashekhar Nair, Director, Bigtec Labs insists. He says, â€œWhat usually happens in a lab is that on receiving a sample, the technician waits till the required number of samples are collected before carrying out the PCR. Due to this, there is usually a delay in carrying out the test. In this light we focused on developing the product such that each individual would get results in about 30-40 minutes.â€? TrueLab differentiates itself by being a product developed indigenously in India and hence offers a major cost advantage. The price of the device will be roughly 1/5th of the cost of a PCR machine which costs upwards of 10 lakhs. The subsequent cost of carrying out the test is also reduced accordingly. XCyton to tackle monsoon diseases XCyton Diagnostics' Syndrome Evaluation System offers to make diagnosis simpler for the treatment of monsoon-related diseases such as leptospirosis, dengue, and malaria. The idea behind the SES is to simultaneously detect multiple pathogens. This is facilitated by performing a multiplex amplification followed by detection of the amplified product using reverse dot-blot assay. Primers used for the amplification are designed using virulent specific genes of each pathogen. The amplified products (amplicons) thus obtained are hybridized on an SES platform embedded with signature specific probes for each of the pathogen. The hybridized amplicon probe mixture is detected by an enzymatic reaction that will yield a visible colored spot. Venus' drug gets US patent Venus Remedies, has received a patent from the US Patent Office for a new drug CSE1034, an antibiotic adjuvant entity (AAE). It is effective against a wide range of drug resistant infections including the 'superbugs' such as carbapenemase resistant Metallobetalactamses (MBL) strains. Dr Mufti Suhail Sayeed, vice president, Venus Medical Research Centre, says, â€œThe US patent of CSE 1034 for Venus Remedies is a landmark development for initiating the process of commercialization of this novel drug, designed specifically to target growing bacterial resistance mechanisms.â€? It is planning to launch this drug in India under the brand name ELORES. Bharat Biotech, CVD recieve $4mn award Bharat Biotech and University of Maryland Center for Vaccine Development (CVD) have received a $4 million Strategic Translation Award from The Wellcome Trust for clinical development of a new conjugate vaccine. This grant will cover the initial clinical trials beginning in three years to prevent the potentially lethal infectious disease caused by invasive non-typhoidal Salmonella (NTS). NTS have emerged as an important cause of invasive bloodstream infection in sub-Saharan Africa, among young children with malaria and malnutrition, and among adults with HIV; approximately 20-30 percent of children with such invasive NTS infections die. Experts from Bharat Biotech and University of Maryland are upbeat on the prospects of developing NTS Conjugate Vaccine. They stated that this project represents a true translational public-private partnership that not only enables potentially lifesaving vaccine technology to move towards the marketplace and to the public health arena, but also demonstrates international multi-party technology transfer collaborations to help advance its science. The University of Maryland CVD has brought in significant grant funding over the past few decades to support its extensive programs, but this recent achievement of Wellcome Trust funding for its collaborative NTS Vaccine Development project with Bharat Biotech holds special significance. Boehringer, Lilly launch Linagliptin Boehringer Ingelheim India and Eli Lilly and Company India, which represent the Boehringer Ingelheim â€“ Lilly global alliance in the country, launched Linagliptin (brand name Trajenta) 5 mg film-coated tablets. Trajenta (Linagliptin 5 mg tablets) is the alliance's first new product introduction, globally. In India, the Boehringer Ingelheim-Lilly alliance already co-promotes Humalog (Injection Lispro). Linagliptin (Trajenta) is an original research product of Boehringer Ingelheim. It is approved in the United States, the European Union and Japan, among other countries, including India. The approval of Linagliptin 5 mg (Trajenta) was based on a clinical trial program which involved approximately 6,000 adults with type 2 diabetes, including patients from India. The Boehringer Ingelheimâ€“Lilly alliance in India now offers oral anti-diabetics as well as contemporary injectable insulins. These offer a choice to the doctor in deciding the optimum therapy, depending on the patient's needs. The product will leverage the alliance's distribution network and will be available on prescription in pharmacy outlets across the country from June 20, 2012. â€œPatented products still have relevance in generic eraâ€? At the Drug Information Associates (DIA) workshop held in New Delhi, the experts deliberated on the IP innovation and collaborations. The workshop familiarized the participants with the basic theory and practice of IP regimes in an organization and the responsibilities of industries involved in intellectual property trade. Through this workshop, DIA brought to the forefront various dimensions of licensing associated with IP protection. On the occasion, K S Kardam, deputy controller of patents and designs, Intellectual Property Office said, â€œOur Indian companies are just beginning to realize that they also need an R&D department as merely quality control would not help. Unless spending on R&D is scaled up, it will be difficult to create new molecules.â€? The event was attended by the policy makers, scientists, academicians, IPR professionals and entrepreneurs. As a part of the deliberations, DIA also put forth the key aspects about claim writing along with practices in different jurisdictions from the EU, US and Indian perspective. The participants were also given training on know-how on licensing and the scope of India as an investment destination. Apart from educative sessions, speakers also provided interesting insights about issues such as patent scenario, research collaboration between industry and academia, recent CL decision in India and underlying patent related issues in specific cases. Policy issues relevant to Indian scenario like patent pooling, open source innovation and India as International Search Agency were also discussed during the sessions. ]]> <![CDATA[BIRAC]]> https://biospectrumindia.com/news/95/1484/birac.html https://biospectrumindia.com/news/95/1484/birac.html Tue, 17 Jul 2012 11:47:00 +0530 Biotechnology Industry Research Assistance Council (BIRAC), a 'Not-for-Profit Company' of Government of India, registered under India Companies Act 1956, as the Department of Biotechnology's interface agency, serves as a single window for the emerging biotech industries. BIRAC is guided by an Independent Board of Directors comprising senior professionals, academicians, policy makers and industrialists. BIRAC aims to become a dynamic organization, applying unique methodologies for nurturing the high risk projects which hold potential for commercialization. BIRAC would like to position itself as an organisation nurturing and promoting innovation led research and will play an important role as a facilitator and not merely a service provider. Taking discovery forward to product development BIRAC Operational Mode BIG Biotechnology Ignition Grant BIRAC offers Biotechnology Ignition Grant (BIG) to scientist entrepreneurs from research institutes, academic private sector and start ups, who have an exciting idea which may be in the nascent and planning stage. This scheme is designed to stimulate commercialization of research discoveries by providing very early stage grants for the development and maturation of those discoveries into marketable product or intellectual property (IP), in particular to help bridge the gap between discovery and invention. The purpose of the BIG Scheme is to: pscale and validate of Proof of Concept Encourage researchers to take technology closer to market through a Start Up Excite interest of potential licensees or investors The scheme is managed by the BIG Partners who work with the Ignition grantees (BIG Innovators) to provide mentoring and hand-holding for activities related to mobilizing resources, IP management, legal and contracts and other business development related activities for the BIG innovators. The BIG Partners monitor targeted milestones for disbursement of funds and also organize workshops and networking meetings for facilitating interaction with senior experts. Target Groups- The Biotechnology Ignition Grant (BIG) scheme is for potential entrepreneurs from Academia or an Incubatee (PhDs, Medical degree holders or Biomedical Engg. Graduates) who have an exciting idea which may be in the nascent and at a planning stage and have an unmet need for mentorship and funding from Angel Investors or Venture Capitals in India. The Biotechnology Ignition Grant would help to support and nurture these high risk early starters and their concepts. BIPP Biotechnology Industry Partnership Programme Biotechnology Industry Partnership Programme (BIPP) is a government partnership with Industries for support on a cost sharing basis for path-breaking research in frontier futuristic technology areas having major economic potential and making the Indian industry globally competitive. It is focused on IP creation with ownership retained by Indian industry and wherever relevant, by collaborating scientists. BIPP supports the development of appropriate technologies in the context of recognized national priorities in the area of agriculture, health, bio-energy, green manufacturing, when the scale of the problem has serious consequences for social and economic development. BIPP is an Advanced Technology Scheme only for high risk, transformational technology/process development. It is for high risk futuristic technologies and mainly for viability gap funding. The uniqueness of this scheme is that it is for â€œBreak through researchâ€? which enables product and process development and is patentable, with IP ownership rights resting with industry. Target Groups- Indian Biotech companies regulated under Indian Company Act 1956 with 51% Indian shareholding (including NRI's) who have DSIR recognized R&D are entitled for BIPP funding, either independently or in collaboration with companies, not for Profit organisation or academics partners. So far 88 agreements have been signed with 72 companies involving aprrox. 50 startups and SMEs. Scheme provides for both soft loan and grant. A total of investment of US $ 141m has been committed with US $ 50m by Govt. of India with a matching contribution of US$ 91m coming in as private sector contribution. SBIRI Small Business Innovation Research Initiative The Small Business Innovation Research Initiative (SBIRI), a scheme launched in September, 2005 by the Department of Biotechnology (DBT), aims to encourage small and medium scale industries to take up risk in innovative R&D in biotech sector. The main focus is on supporting proof of concept and early stage research in startups and SMEs. Over 100 projects from small and medium entrepreneurs have been supported. SBIRI has deployed $36 million, of which $5 million in grants and $31 million in soft loans, with a debt-to-grant ratio of roughly 6 to 1. Public SBIRI funding has leveraged an additional $33 million in private investment by recipient enterprises as their core contribution, for a total investment of $69 million across approved projects. CRS Contract Research Scheme BIRAC endeavours to extend its support to Academia in the form of grant-in aid for validation of the Proof of Concept (PoC) by an Industrial partner. Why CRS- The CRS scheme supports the academia-industry interaction between research institutes, universities, public funded research laboratories, governmental organizations, research foundations and companies / industries under the Public-Private Partnership (PPP) mode. Target Groups- Under this CRS Scheme, Public Sector Research Institutes, Universities who have already generated or have pre-existing scientifically established proof of concept/leads seek support for specific research and validation process to be performed by a company partners within a defined time frame. The industry partner in turn would complete the Validation Phase in a Contract Research mode. The IP rights belong solely to the academic partner(s). In addition, if the Academic group requires some specific services from the industry such as toxicology, sequencing, use of specific equipment etc. are also supported under this scheme. Public and/or Private Universities and Research Institutions are eligible to apply under the Contract Research and Services Scheme with pre-determined company partner(s) having DSIR recognized R&D/Service unit(s). BIRAC not only funds the validation of proof-of-concept but works closely with academic research scientist to provide them enabling services of FTO search, IP management. The Legal and Contracts Cell facilitates preparation of required Material Transfer Agreement, Non- Disclosure Contracts, IP protection contracts and when required licensing agreements. BIRAC ensures complete protection of IP rights of the academia scientist and also facilitation technology transfer. BISS Bio-incubator Support Scheme In order to foster techno entrepreneurship in biotechnology, BIRAC has initiated a scheme for Strengthening and Up-gradation of the existing Bio-incubators and also to establish New World Class Bio-incubators in certain strategic locations. These Bio incubators will provide the incubation space and other required services to start-up companies for their initial growth. Strengthening existing Bio-incubators The Bio-incubators for SMEs and start-ups could be as a stand-alone facility or as a part of an existing University/ Institute or Science Park. The BIRAC Bio-incubator strengthening support is provided to those existing Incubators which have proven experience and competence to run successful incubators, have an existing network for mentoring and handholding of incubatees, and also can provide the enabling services to promote innovation research. There should be a well-structured governance model which allows for such activities to be conducted within the host institute, providing the required autonomy and flexibility for operation. Establishing World Class Bioincubators BIRAC is will also set up a limited number of new World Class State of Art, National Bio-incubators at strategic locations, especially in an around the DBT Bio-clusters. These would be closely located to existing Academic hubs and have a well-developed management model. It would provide the required infrastructure, incubation space, access to central equipment and pilot plant and enabling services. Most importantly the proximity to the Academic Centres of Excellence would provide access to the Translational Research strength and capacities. These BIRAC Bio-incubators would benefit from the close interaction with the Academic Institute in the cluster and on the other hand provide opportunities to the scientists / entrepreneurs who could create their own spin offs, or are incubated in close proximity to the Academic Centre of Excellence. The two way flow of knowledge between Academia and Start-up would be beneficial to both and provide a boost and help nurture innovative technologies for affordable product development. Seven existing Bio-incubators across the country have been strengthened and approximately 55,000 Sq.ft of Bio-incubator space has been created to support start up. BIRAC shall operate as an organization which will act as a facilitator and not merely as a service provider. BIRAC looks ahead to creating a Biotech Innovation Enterprise which is at par with the Global Best. Product innovation and commercialization for addressing Grand Challenges of national relevance BIRAC will shortly launch the Grand Challenges Programme, offering researchers and scientist opportunities to innovate and work on scientific and technological solutions for affordable product development to meet national needs. The Grand Challenges have one common defined goal: â€œCreate Scientific and technological tools to overcome hurdles and find solutions for novel affordable products of national relevanceâ€?. High level of innovation, new tools and transformative ideas would be supported. These could be in health care, agriculture and energy. These Grand Challenges Programmes could be implemented in an industry - academia partnership model to be co-funded with strategic partners through both national and global alliance. These could be self-governed consortia with clearly defined milestones, deliverables, management models and IP sharing contracts. Services for Entrepreneurial Development IP Services Technology Transfer and Acquisition Legal and Contracts Policy and Analysis Mentoring & Capacity Building For details contact - Dr Ravi Dhar, Senior Consultant, Biotechnology Industry Research Assistance Council ( BIRAC), Email: rdhar.birap@nic.in ]]> <![CDATA[Man on a Mission: IT tycoon meets Indian vaccines czar]]> https://biospectrumindia.com/news/95/2151/man-on-a-mission-it-tycoon-meets-indian-vaccines-czar.html https://biospectrumindia.com/news/95/2151/man-on-a-mission-it-tycoon-meets-indian-vaccines-czar.html Tue, 17 Jul 2012 11:41:00 +0530 As a part of his â€œEnd Polioâ€? campaign in India, Bill Gates paid a visit to the facility of India's vaccine leader, Serum Institute of India and is looking at forging ties for its Rotavirus and polio vaccines Towards the beginning of June, Microsoft founder and co-chairman of the Bill and Melinda Gates Foundation, Bill Gates paid a visit to the facility of India's top vaccine manufacturer, Serum Institute of India (SII), Pune and met up with its CMD, Dr Cyrus Poonawalla, whom he has referred to as one of the seven vaccine heroes. Gates had come on a visit to India, wherein he traveled to New Delhi, Bihar, UP, Pune, and Bangalore. He also met the newly appointed Chief Minister of Uttar Pradesh, Mr Akhilesh Yadav. During his visit to SII, Gates had expressed interest in many of SII's pipeline of injectable vaccine products. It is most likely that Gates will look at forging ties with SII for its polio vaccines and rota virus vaccines immediately. Speaking to BioSpectrum, Dr Cyrus Poonawalla, CMD, SII mentioned, â€œBill Gates is impressed with SII because we have been successful in providing a large array of vaccines and at affordable prices to the developing countries of the world. He was keen on visiting our facility. Most of our vaccine products, mainly injectable vaccines like polio and Rotavirus are of immediate interest to him. He wants us to make those available at an affordable cost.â€? In addition to this, Gates also welcomed the initiative of SII for slashing the cost of its recently launched 5-in-1 pentavalent vaccine by 60 percent for the developing nations of the world. â€œCyrus Poonawalla is among the seven vaccine heroes and is a multiple winner with vaccines against measles and others. He has deeply affected the vaccine world and people are dependent on the quality work done at Serum,â€? Gates stated to the media. Adar C Poonawalla, executive director operations, SII, informed BioSpectrum that, â€œThis is a long term partnership. The foundation will look at pooling in funds for the development of some of our vaccines.â€? According to Dr SD Ravetkar, executive director, SII, â€œGates is highly focused on affordable vaccines and despite being from the IT sector, he has a deep understanding of the vaccine sector, which is an amazing trait.â€? Gates has been proactive in the development of vaccines for unmet diseases and at affordable costs. Back in 2010, at the World Economic Summit in Davos, which declared 2010-20 as the â€œdecade of vaccinesâ€?, Gates had announced that he was allocating a sum of $10 billion towards the development and delivery of vaccines to the developing nations of the world. This would be for diseases such as malaria, tuberculosis, pneumonia and diarrhea, for which vaccines are yet to be made available. He further said that availability of vaccines for these diseases would save around eight million children by the end of 2020. In March 2011, Gates along with wife Melinda Gates paid a visit to India and met the policy makers and other stakeholders and announced that they would be allocating a sizable amount of funds for the late stage clinical trials to SII and Hyderabad-based, Bharat Biotech, for pneumonia and Rotavirus vaccines. ]]> <![CDATA[Expert Opinion - K V Venugopalan]]> https://biospectrumindia.com/news/95/3792/expert-opinion-k-v-venugopalan.html https://biospectrumindia.com/news/95/3792/expert-opinion-k-v-venugopalan.html Mon, 16 Jul 2012 20:13:00 +0530 CHROMATOGRAPHY Trends in HPLC sphere LC market in India was about $240 million including after market and service in 2011 Over the past 30 years, high performance liquid chromatography (HPLC) has become one of the most widely used technologies in laboratories worldwide. This is due to the fact that HPLC is a dynamic and versatile technique. It is dynamic in its scope of application from capillary scale to preparative scale and it is versatile in the range of detection techniques that can be associated with it, providing analytical capabilities over a broad spectrum of compounds. Pharmaceutical research for new drugs and delivery systems is probably the single largest application area for liquid chromatography. HPLC systems are also used in various other industries including petrochemicals, pesticides, cosmetics, power generation, food quality and safety, chemical materials, and environmental testing. Propelled by the need to meet increasing scientific and business challenges, liquid chromatography has evolved over the years. Innovations in the area of separation chemisty, detection systems, and data handling are noteworthy. At a time when many scientists have reached separation barriers and are pushing the limits of conventional HPLC, ultra performance liquid chromatography (UPLC) presents the possibility to extend and expand the utility of this widely used separation science. ACQUITY Ultra Performance LC Systems introduced by Waters in 2004 take advantage of technological strides made in particle chemistry performance, system optimization, detector design, and data processing and control. When taken together, these achievements have created a step-function improvement in chromatographic performance. The UPLC/UHPLC technique has gained wide acceptance in the laboratory due to its ability to provide more information per unit of work as it fulfils the promise of increased speed, resolution and sensitivity for liquid chromatography. As per SDI estimate UPLC is the fastest growing LC market segment and worldwide market in 2011 was dominated by Waters (60 percent) followed by Agilent (17 percent) and Shimadzu (eight percent). HPLC market In 2011, LC market in India was about $240 million including after market and service, representing close to 20 percent of the total analytical instrument market of $1.2 billion and projected to grow between 10-15 percent, depending upon the external economic conditions. This amounts to approximately 4000 LC systems (including UPLC systems) and more than 100,000 columns and large quantities of sample preparation products. After market is about $80 million (accessories and supplies including columns and sample preparation products) and services of approximately $65 million in 2011. Waters leads the market followed by Shimadzu and Agilent and the top three companies hold more than 80 percent of the Indian HPLC initial systems market. With an installed base of over 30,000 active HPLC systems across the country, majority of them operating 24/7 in the generics pharma sector, India would consume approximately 100,000 to 120,000 columns per year. The rapidly growing bioanalytical sector (CRO) alone consumes around a million sample prep devices, while the overall consumption of vials is difficult to estimate but is expected to add up to several million. Given this huge potential, close to $80 million, it is not surprising that almost all column and sample prep manufacturers are present in the country either directly or through distributors. Some of the significant players listed alphabetically are Agilent, Daicel, GL Sciences, Grace, Machery Nagel, Merck, Phenomenex, Sigma Aldrich, Thermo, Waters, Whatman, and YMC. Market segments and growth drivers The pharmaceutical and life science market are, by a considerable margin, the largest individual sources of demand, making up more than 65 percent of the total market. R&D labs, method development, and QA/QC are the main areas where LC systems are used extensively. The public sector, consisting of academic and government labs, forms another 13 percent of the market. Government expenditures on academic and research have grown along with the GDP of the country, and several important initiatives are leading to rapid growth in the HPLC market including pharmaceutical development, food and environment, chemicals and biotechnology. CSIR, ICAR, ICMR, Food and Drug testing labs, Pollution Control boards, DBT, and DST form the major users of LC systems. Opportunities and challenges Indian pharmaceutical industry contributes more than 65 percent for the HPLC market and continues to grow in spite of current economic conditions. Driven by top 25 companies in this sector whose export business constitutes more than 75 percent of their total turnover, this segment is poised to grow even more in the coming years as many blockbuster drugs are going off patent. CROs, government labs, food safety, and environmental laboratories are other markets that provide growth opportunities for the Indian analytical industry. Today's users demand superior product at the lowest possible cost, where cost is not just the initial purchase cost but also cost of ownership, operation and maintenance. They also demand excellent, effortless, less expensive and hassle-free service to remain loyal to a particular vendor and all these demands seems to be conflicting. Even though vendor-switching is not easy due to regulatory and training issues, overall cost and support issues can make it easy, particularly in a challenging economic environment. A modern analytical laboratory faces a variety of regulatory and operational challenges including operating in compliance with cGMP and other applicable industry regulations, asset optimization, consistently generating reliable and trustworthy data, minimizing errors, and levels of retesting and waste. Intellectual property and knowledge management are other important challenges of growing organizations.  HPLC Market Trends  Market % share Pharma & Life Scienes 65 Academia 6 Chemical Materials 8 Govt. Labs 7 Food & Environment 5 Others 9 HPLC market expected to grow at 12% - K V Venugopalan, president, Waters India An electronics engineer, with MBA degree in marketing, Mr Venugopalan has been associated with Waters India from 1983. He joined Waters as a service engineer in 1983 at Mumbai and rapidly rose to become the Regional Manager in 1986. During 1988, when Waters Corporation set up its joint venture operations in India, he became the general manager for Waters India. When it was decided to make Waters India a 100 percent owned subsidiary during 1997, he became the president with total responsibility for Indian operations. ]]> <![CDATA[Profiles - Advanced Microdevices]]> https://biospectrumindia.com/news/95/2261/profiles-advanced-microdevices.html https://biospectrumindia.com/news/95/2261/profiles-advanced-microdevices.html Mon, 16 Jul 2012 20:11:00 +0530 Consistent growth Continuing to repeat its growth performance Advanced Microdevices recorded 18% growth in the FY 2011-12 Advanced Microdevices (MDI) is one of the largest filtration and separation materials manufacturers in India with an exceedingly vast range of products. The company has created a niche for itself by developing the latest technologies at low cost and commercializing internationally accepted products at competitive prices. As compared to 68 crore in the previous fiscal year, the company recorded 85 crore as revenue in the FY 2011-12. The company has been growing at a rate close to 20 percent annually. The entire manufacturing technology of this research-based company has been developed in-house to produce a variety of membranes having applications in sterilizing filtration in pharmaceutical and biopharmaceutical industries. The company has deep penetration in Indian biopharmaceutical industry and enjoys dominant position in many product segments. An overseas office has been set up in California and it is looking at setting up a new joint venture company in the US. Advanced Microdevices has included the nucleic acid isolation, purification, and separation kits in its product range. The company also produces very consistent nitrocellulose membranes for rapid immunodiagnostic tests. The MDI red blood cells (RBC) separator for lateral flow tests is considered to be the best in the market in terms of efficacy and efficiency. A unique rapid plasma separation device has been developed for use with quantitative diagnostic analyzers and point of care applications. The focus at MDI is on using its membrane technologies as a platform for developing new value added products for use in filtration and separation. MDI has a unique interdisciplinary expertise which allows it a very fast turnaround in developing new and customized products for its customers. MDI's product portfolio boasts of more about 15,000 products, with many more in the pipeline at various stages of research and development. The products are manufactured in an ISO 9001:2008 certified production facility and are CE certified. The company has also set up a new 85,000 sq. ft state-of-the-art GMP facility at a cost of more than 20 crore. This facility includes a 10,000 sq ft clean production area with a capacity of more than five times the current production capacity. It also houses a 9,000 sq. ft. well equipped filter validation lab with all necessary instruments to deal with modern day drug formulations, novel drug delivery systems (NDDS), oncology drugs, and therapeutic recombinant proteins. | Business: Production of microporous membranes and separation products MD: Nalini Kant Gupta Revenue: 85 crore Start-up year:1976 Address:No.20-21, Industrial Area, Ambala Cantt -133 006, Haryana Tel: 91-171-2699290, 2699471 Website: www.mdimembrane.com ]]> <![CDATA[Profiles - Imperial Life Sciences]]> https://biospectrumindia.com/news/95/1577/profiles-imperial-life-sciences.html https://biospectrumindia.com/news/95/1577/profiles-imperial-life-sciences.html Mon, 16 Jul 2012 20:09:00 +0530 Increased alliances, more products Imperial Life Sciences is exploring untapped opportunities in the areas such as third generation sequencing and molecular diagnostics Maintaining its consistent performance, Imperial Life Sciences (ILS) has grown by 13 percent in FY 2011-12. The company clocked revenues of 152.70 crore from sale of its bioscience products. Being an exclusive representative of leading global players in India, ILS provides complete solutions in instrumentation, reagents, bioinformatics, consumables, genomics, proteomics, cell culture, drug discovery and bioproduction. In 2011, ILS forged several new relationships to expand its business. It tied up with Affymetrix for microarray systems and arrays; New England Biolabs (NEB) for its extensive range of molecular biology reagents including restriction enzymes; and (GMI) for its state-of-the-art PET/SPECT/CT. The company also partnered with Miltenyi Biotec for MACS Quant flow cytometers, AutoMACSPro cell seperators, and an extensive portfolio of cell biology reagents. ILS made a strategic move to bring third generation sequencing solutions by entering into a partnership with Pacific Biosciences. The company is also looking at consolidating its advanced molecular diagnostics business. According to ILS the range of products from NEB to Affymetrix have been significant business drivers, while Caliper and Miltenyi Biotec have been significant revenue generators. The consumables business for ILS today accounts for 40 percent share of its total business. The company also made a notable growth in the microarrays segment ILS has doubled its employee strength to increase its penetration in the Indian market. It not only increased its product portfolio, but has also diversified its business by creating individual business groups viz: genomics division; cell biology and imaging division; and consumables and reagents division. According to Neeraj Gupta, director, sales and marketing, Imperial Life Sciences, â€œWe believe in providing quality products to our clients and, therefore, continue to maintain close association with all our key clients. We will try our best to continue growth in current business segments. The establishing of a new division of advanced molecular imaging providing state-of-the-art technologies for Indian customers is also on our cards.â€? | Business:Supplier of products used in biotechnology and molecular biology research MD: Suresh Kumar Gupta Revenue: 152.7 crore Start-up year:1992 Address: Plot No. 463, Sector 37-II, Pace City II, Gurgaon -122 001, Haryana Tel: 91-124-4559800-99 Website: www.imperialls.com ]]> <![CDATA[Profiles - Agilent Technologies]]> https://biospectrumindia.com/news/95/2185/profiles-agilent-technologies.html https://biospectrumindia.com/news/95/2185/profiles-agilent-technologies.html Mon, 16 Jul 2012 20:07:00 +0530 Progress through innovation With continuous improvisations and additions into product portfolio, Agilent Technologies continues to maintain a good hold over the Indian chromatography market Agilent Technologies is one of the few players which has a complete portfolio of mass spectrometry techniques that spans the various application needs of the industry. In FY 2011-12, Agilent India's life sciences business is estimated to be 365.7 crore as compared to 318 crore in FY 2010-11. Bulk of Agilent's Life Sciences and Chemical Analysis (LSCA) business comes from sale of its products and solutions to the pharma sector. The expansion of LSCA Center of Excellence and the setting up of application development lab have helped it to accelerate the discovery of life science analysis work flows; both making it the largest research facility in the world. The acquisition of Varian has broadened and strengthened Agilent's product portfolio. Similarly the decision to acquire Dako, a leading cancer diagnostics solution provider, has opened new avenues for the company. Agilent signed a research sponsoring agreement with Amrita University for providing consumables valued at $10,000 and offers extensive service and support. The company along with Department of Science & Technology (Government of India) and Confederation of Indian Industry launched the third season of nationwide i3 innovation competition for all innovators. Over the years, Agilent's mass spectrometry products have also seen a big jump in revenues. The company has introduced many new products including automated card extraction LC/MS system, a fully integrated instrument for analysis of dried blood spots and other dried media, integrated UHPLC-DAD system, and 2D-LC solution with highest resolution. The next generation Agilent 7100 Capillary Electrophoresis (CE) system has been claimed to provide at least 10 times more sensitivity than any other commercial CE instrument. Its industry-bench marked 1200 series HPLC and 7890 GC have been the biggest revenue generators. Agilent's Rapid Resolution LC (RRLC), has been a big success in the pharma segment. Agilent also launched 6420 triple quadrupole LC/MS system, a replacement for the 6430 and 6460 systems. Besides that, the company recently introduced 6550i Funnel quadrupole time-of-flight chromatography mass spectrometry (Q-TOF LC/MS) system. The world's leading premier measurement company is expanding its thought leadership to introduction of new products and commiting to extensive research. | Business: Lab equipment and research products President and Country General Manager: Parmeet Ahuja Revenue: 365.7 crore* Start-up year: 1989 Address: Plot No. 10, Udyog Vihar, Phase IV, Gurgaon-122016 Tel: 91-124-4727000 Website: www.agilent.com ]]> <![CDATA[Profiles - Nilsan Nishotech Systems]]> https://biospectrumindia.com/news/95/2367/profiles-nilsan-nishotech-systems.html https://biospectrumindia.com/news/95/2367/profiles-nilsan-nishotech-systems.html Mon, 16 Jul 2012 19:27:00 +0530 Separation technology sustains growth By exploiting cutting-edge technologies in sterile process distribution, molecular filtration, separation and purification systems, Nilsan Nishotech displayed an increase in revenue this year Nilsan Nishotech Systems is a supplier of separation technologies and filtration systems to the pharma and biopharma industry. It offers integrated and customized solutions comprising design, engineering, manufacturing, installation, and commissioning for process plant and equipment in the areas of sterile process piping, high purity water systems, and separation technologies. For fiscal 2011-2012, it clocked an annual turnover of 39 crore as against 30 crore in the previous fiscal. Nilsan Nishotech focuses on separation applications by offering customized filtration, separation and purification solutions with technology portfolios of membranes, chromatography and ion exchange to industries. Expertise of the company clearly lies in API/bulk drug manufacturing formulations. Some of the company's clients include Divis, Cipla, Matrix, Serum Institute of India, and Torrent. Nilsan Nishotech also imparts engineering skills with international technological process made available through its global partner, Novasep Process, a part of Groupe Novasep. The Nishotech-Novasep association provides solutions using membrane and prep-chromatographic technologies. Novasep Process' core technologies are chromatography, crystallization, ion exchange, msembranes, and evaporation. Additionally, DrM is a technology partner for Nilsan Nishotech system for their patented candle filtration design. DrM, Switzerland is the inventor of the â€œLUWAâ€?, a thin film evaporator and FUNDA-filter and over 400 patent applications in total. The FUNDABAC and CONTIBAC range of filters have been the newest developments and in the meantime, there are over 1500 filters in operation worldwide and about 80 new systems are installed every year; most of them in the chemical industry, but also in petrochemical, pharmaceutical, food and industrial waste water applications as well. During the year, Nilsan Nishotech has struck deals with pharma and biotech companies like Gadre Marine, Glenmark, GSK, Mylan, and Zydus Cadila. The company also launched products which include clean in-place systems to FMCG and healthcare sector, project recovery systems, purified water generation systems. The essential factors which paved the way for the company's growth includes trouble shooting capabilities of its expertise, understanding the engineering requirements, and providing innovative solutions. | Business: Supplies separation technologies, filtration systems to the pharma and biopharma industry Start-up year:1989 Revenue: 39 crore CEO: Sanjay Badani Address:W-99-E , Midc, Khairne , Thane belapur road, Navi Mumbai - 400705, Maharashtra Tel: 022-41515151 Website: www.nilsan-nishotech.com ]]> <![CDATA[Profiles - Adam Fabriwerk]]> https://biospectrumindia.com/news/95/5671/profiles-adam-fabriwerk.html https://biospectrumindia.com/news/95/5671/profiles-adam-fabriwerk.html Mon, 16 Jul 2012 19:26:00 +0530 Riding high on skids and systems Company's focus over the past one year has been on key markets and integrated processing systems which has led to high volume skid manufacturing Adam Fabriwerk has been delivering mixing and processing skids to biopharmaceutical and pharmaceutical industries, since 1980. It, today, manufactures processing systems for pharmaceutical, biopharmaceutical and also for the cosmetic industries. The company manufactures processing skids and systems ranging from 5-20,000 liters. Systems are manufactured in its state-of-the-art manufacturing plant for integrated skids. Its product portfolio includes aseptic processing skids, CIP/SIP modules, and cream processing systems. For fiscal 2011-2012, the company clocked revenues of 50 crore as against last year's revenue of 42 crore for fiscal 2010-2011. During the year, the company has seen some major deals coming for monoclonal antibodies, vaccines and oncology processing skids with major domestic and international companies. Its focus so far over the year has been on key markets and integrated processing systems which has led to high volume skid manufacturing. Products and services launched during the year included integrated processing skids for biopharma applications. Since the past 26 years, the company has been operating its fabrication works in Nashik with corporate office in Mumbai. Adam Fabriwerk offers clients the opportunity to view first hand its machines, the extensive design and manufacturing facilities employed. Facilities are offered to carry out confidential formulation or recipe development, as well as to scale up work and operator training. In fact, its display and training facility has helped scores of potential users get a first hand look at the end products and finalizing on their own project requirements. Adam Fabriwerk in the past has many first to its credentials. It had spearheaded a fully automated cleaning in place (CIP) module and blending vessel with magnetic mixer for Wockhardt Research Center, Aurangabad for vaccines, built-in-raking system for fluid bed dryer for Vikram Sarabai Space Centre Allepy for drying of solid rocket fuel. Some of its current projects include spearheading a fully automated SCADA-based state-of-the-art processing plant for Johnson and Johnson at Baddi, blending vessels with CIP and SIP modules for Serum Institute of India for vaccines and biological products, blending vessels for Reliance Life sciences for plasma fractionation project, and processing vessels with CIP and SIP modules for Dabur Pharma oncology project at Baddi. | Business: Manufactures systems for the pharmaceutical, biopharmaceutical companies CMD: Waman Wagh Revenue: 50 crore Start-up year:1980 Address:702,Tanishka, Akurli road, Kandivali-East, Mumbai - 400 101 Tel: 91-22-61776700 Website: www.adamfabriwerk.com ]]> <![CDATA[Profiles - Medispec India]]> https://biospectrumindia.com/news/95/1955/profiles-medispec-india.html https://biospectrumindia.com/news/95/1955/profiles-medispec-india.html Mon, 16 Jul 2012 19:24:00 +0530 Concentrating on high-end products Instead of spending its sales efforts in chasing low-value instruments, the company this year concentrated on high-value sales Medispec India (MIL) is involved in marketing, sales and service of medical, analytical, and diagnostic laboratory products for overseas manufacturers. Its products include microplate instrumentation systems, CO2 incubators, bio-safety cabinets, laminar flow hoods, gel documentation systems, molecular biology systems, variety of lab equipment, microbial contamination detection systems, and personal protection suits. The company clocked revenues of 69.16 crore in 2011-12 as against 58.38 crore in 2010-11. This year, despite a slump in the overall industry and cut in R&D spends, the company saw a growth in its sales. Vippul Chhatbar, managing director, MIL, says â€œWe managed to get orders and thus be on our growth path.â€? Instead of spending its sales efforts in chasing low-value instruments, the company this year concentrated on high-value sales. â€œWe were able to secure business from new start-ups,â€? adds Chhatbar. The installed base for MIL has crossed 2,000 systems this year. During the year, MIL also introduced a new range of products in the Indian market. This included a new range of synergy multi mode readers and touch-screen microplate washers from BioTek Instruments. MIL also added more advanced CO2 incubators from Nuaire to its portfolio. â€œWe started with ELISA processors last year. These handle eight micro plates, bringing down the sample turn-around time in diagnostic labs for multiple assays. We also launched HTC range from our principal Ditabis. The products are thermo mixers, block thermostats and aspiration systems,â€? informs Chhatbar. The company has been distributing products for eight principals and this year it started distributing for additional companies which includes Ditabis for thermo mixers and heating blocks, Aikang Electronics for walkaway ELISA processors, and Kaltis for deep freezers. Looking at the next 12 months, the main focus for the company would no doubt be the pharmaceutical sector. â€œHowever with rupee weakening and an anticipation of slow growth, we plan to increase our product range such as walkaway processors, reagents and related products in our diagnostic division,â€? adds Chhatbar. MIL is also looking to leverage on cervical screening by adding HPV testing. The other possibility that MIL is exploring includes particle counters to check cleanliness of environment in lab and other critical areas. | Business: Marketing, distribution, installation, servicing and calibration of biomedical, analytical, scientific and diagnostic systems CEO: Vippul Chhatbar Revenue: 69.16 crore Address: Unit 223, Link Way Estate, New Link Road, Malad (West), Mumbai - 400 064 Tel: +91-22-28739944, 28734567 Fax: +91-22-28759944 ]]> <![CDATA[Profiles - Eppendorf India]]> https://biospectrumindia.com/news/95/4545/profiles-eppendorf-india.html https://biospectrumindia.com/news/95/4545/profiles-eppendorf-india.html Mon, 16 Jul 2012 19:18:00 +0530 Capitalizing on new products Continuing on the growth trajectory, Eppendorf India crossed the important milestone of being a 100 crore company Eppendorf India registered 13 percent growth in 2011-12 by strengthening its position in the pipetting services, and launching several new products. Its revenues crossed 100 crore mark for the first time and it ended the year with revenues of 102.66 crore. Catering to the academic and research labs in the pharma and biotech sectors. Eppendorf has a strong customer base in India. Eppendorf operates under three segments: liquid, cell, and sample handling products. An important development this year has been the ISO 17025:2005 accreditation of the Eppendorf India Pipette Calibration Center in Chennai by the National Accreditation Board for Testing and Calibration Laboratories (NABL). With this accreditation, the center can now calibrate any make of piston stroke pipette and issue certificate as per the guidelines of NABL. This development has helped the company to consolidate its position in the liquid handling segment of the consumables business. Further, the acquisition of DASGIP was completed in January this year. This acquisition will enable Eppendorf to introduce the bioreactor system, which is used in biofuel production, media optimization and stem cell cultures. The products will be launched in India by the end of this year. Among the slew of products that were released this year, was the BioSpectrometer, a very compact robust spectrophotometer, for measurements in the UV and VIS range. The unique factor of the two versions of the device BioSpectrometer basic and BioSpectrometer kinetic is that the cuvette shaft is temperature controlled so that the enzymes and substrate kinetics can be measured directly in the device. This instrument, which has applications in genomics, proteomics, cell biology and biochemistry has had a good reception so far. Eppendorf launched tissue culture vessels in India for culture of all adherent cell types. This product range includes tissue culture flasks, tissue culture dishes and tissue culture plates. Eppendorf launched this product line to complement the range of existing products such as CO2 incubators, shakers, centrifuges, microinjector and micromanipulator, for culture labs. Also launched this year was Mastercycler Nexus, a new low energy consuming PCR instrument that has an option of sending an e-mail, once the complete cycle is done. The wide range of products has enabled Eppendorf to easily offer complementary products in packages. | Business: Develops, produces and distributes systems for life sciences industry CEO: V Sankaranarayanan Revenue: 102.66 crore Start-up year:2003 Address:Doshi Towers, 4th Floor, 156 Poonamallee High Road, Kilpauk, Chennai - 600 010, Tamil Nadu Tel: 91-44-42111314 Website: www.eppendorf.co.in ]]> <![CDATA[Profiles - Toshvin Analytical]]> https://biospectrumindia.com/news/95/6943/profiles-toshvin-analytical.html https://biospectrumindia.com/news/95/6943/profiles-toshvin-analytical.html Mon, 16 Jul 2012 19:18:00 +0530 Leveraging key partnerships The company has an installation base of over 10,000 instruments and a customer base of over 7,500 Toshvin Analytical, one of the key players in India in the field of analytical and laboratory equipment has clocked revenues of 100.45 crore in 2011-12 as against 89.7 crore in 2010-11. The company's principal products encompass the domains of pharmaceutical, life sciences, and allied industries. Toshvin has been representing Shimadzu since 1970, exclusively in India for a wide range of products such as UV-Vis, FTIR and AA spectrophotometers, Single Drop UV-Vis spectrophotometer, gas chromatographs (GC) and GC-mass spectrometers (GCMS), thermal analyzers, spectrofluorophotomers, particle size analyzers, and ICP spectrometers. It is also associated with Restek Corporation, USA for chromatography columns and accessories. This year, the new products (introduced by Shimadzu, Singapore) that Toshvin will be distributing include UV Visible spectrophotometer Model UV- 2600, Shimadzu spectrophotometer for Life Science Model BioSpec-nano, gas chromatograph Model GC-2025, and Versa Automated Head Space Vial Sampler. Toshvin has an enviable installation base of over 10,000 instruments and a customer base of over 7,500 including some of the largest companies in the field of chemicals, food and allied industries, private testing labs, research institutes, and premier universities. In the pharmaceutical space, some of Toshvin's leading customers include Arch Pharma Labs, Cipla, Dr. Reddy's Laboratories, JB Chemicals, Lupin, Micro Labs Group, Piramal Healthcare and Life Sciences, Ranbaxy, Serum Pharma, Sun Pharma, Watson Pharma, and Zydus Cadila. Toshvin caters to some of the renowned institutes such as Central Food Technology Research Institute (CFTRI), Indian Association for the Cultivation of Science (IACS), Institute for Pesticide and Formulation Technology (IPFT), Indian Institute for Science Education and Research (IISERs), Indian Institute of Chemical Biology (IICB), Indian Institute of Technology (IITs), Jawaharlal Nehru Advance Research and Development Centre (JNARDC), National Chemical Laboratories (NCL), National Institute of Pharmaceutical Education and Research (NIPER), and National Institute of Technology (NITs) to name a few.Toshvin operates through a network of 12 offices to provide effective and efficient marketing, service support to customers, in close cooperation with Shimadzu India's Customer Support Centres. | Business: Distributor of analytical and laboratory equipment for the life sciences industry MD: Nakul Toshniwal Revenue: 100.45 crore Start-up year:1948 Address:103, SJ House, 1st Floor, Sitaram Mills Compound, NM Joshi Marg, Lower Parel, Mumbai - 400 011, Maharashtra Tel: 91-22-23015096 Website: www.toshvin.com ]]> <![CDATA[Profiles - West Pharmaceutical Packaging India]]> https://biospectrumindia.com/news/95/5119/profiles-west-pharmaceutical-packaging-india.html https://biospectrumindia.com/news/95/5119/profiles-west-pharmaceutical-packaging-india.html Mon, 16 Jul 2012 19:15:00 +0530 Delivering enhanced values West Pharmaceuticals generated record sales and made significant progress with its high-value pharmaceutical packaging and delivery systems programs West Pharmaceutical Packaging India (WPPI), a subsidiary of West Pharmaceutical Services (WPS), provides standard-setting systems and device components for parenterally administered medicines. The company has registered an estimated revenue of 124 crore during 2011-12. WPPI has recorded growth rate of over 35 percent in India in the last couple of years. This growth is driving construction of plants in India. The company is setting up a rubber manufacturing facility which is expected to be commissioned in 2013. WPS applies proprietary materials science, formulation research and manufacturing innovation to advance the quality, therapeutic value, development speed and rapid market availability of pharmaceuticals, biologics, vaccines and consumer healthcare products. It serves a wide spectrum of customers, ranging from new domestic manufacturers to multinationals. Some of the major manufacturers served in India include Biocon, Dr. Reddy's Laboratories, Ranbaxy Laboratories and Serum Institute of India. Last year WPS entered into collaboration with other companies to develop devices and evaluate technologies which are of importance to Indian companies. In 2011, WPS announced that it will jointly develop and market a new, needle-free vial access device along with CareFusion, a global medical technology company. The new product is intended not only to help prevent leaks, but also reduce contamination and risk of exposure during a drug product's reconstitution process. WPS also announced an agreement with Amgen, a biotechnology pioneer, to evaluate Daikyo Crystal Zenith technologies for drug containment, which are based on a polymeric container, utilizing elastomeric components with flurotec barrier film, and provided in a sterile, validated, ready-to-fill format. In November 2011, WPS collaborated with Vetter, a leading international independent specialist in the aseptic filling of drug-delivery systems, to provide customers with the ability to source filled Daikyo Crystal Zenith syringes. WPS announced the availability of a new line of steam-sterilized plungers for prefillable glass syringes under its NovaPure brand. Through a product development process that incorporates quality by design principles, NovaPure components, including serum and lyophilization stoppers and syringe plungers, will help to ensure the safety, efficacy and purity of injectable drug products. | Business: Pharmaceutical packaging and delivery systems Country Manager: AR Alagu Subramaniam Revenue: 124 crore Start-up year:1992 Address:79, Uma Nagar, Kundanbagh, Begumpet, Hyderabad - 500 016 Tel: 91-40-40179378 Website: www.westpharma.com ]]> <![CDATA[Profiles - Sigma Aldrich Chemicals]]> https://biospectrumindia.com/news/95/1567/profiles-sigma-aldrich-chemicals.html https://biospectrumindia.com/news/95/1567/profiles-sigma-aldrich-chemicals.html Mon, 16 Jul 2012 19:14:00 +0530 Targetting wider reach With the inauguration of a new storage and distribution center in Bangalore, Sigma Aldrich is hoping to further improve its presence in the South East Asian markets Sigma Aldrich achi-eved a double digit growth of 20 percent as its revenue stood at 147.60 crore in 2011-12. This is in tune with the accelerated growth that the company is seeing in emerging markets, where countries such as India have contributed greatly to the company's global earnings. In terms of products, Sigma Aldrich has been investing in developing biomolecules and antibodies. Currently, the company offers over 50,000 brands of antibodies. Additionally, Sigma Aldrich is also licensing platform technologies which can be used to conduct further research on creating different cell lines and animal models. To commemorate the completion of two decades in India, Sigma Aldrich inaugurated a new distribution center in Bangalore this year. The $5 million center, spread over 68,000 sq. ft, is meant to enhance its existing storage and distribution capabilities for customers all over Asia Pacific. The existing 10-acre campus will continue to house the administrative offices, sales, marketing and distribution functions, and manufacturing. The state-of-the-art facilities have enabled Sigma Aldrich to achieve a shipping accuracy of 99.91 percent to its customers, since the start of the center. While the company employs over 9,000 employees in 40 countries, in India the company's total strength stands at 250, which includes 45 scientists. About 20 percent of the workforce comprises of the sales and marketing staff. Recently, Sigma Aldrich acquired BioReliance, a provider of global biopharmaceutical testing services. This acquisition was made keeping in mind, the expected growth over the next few years of the life sciences and biopharma industries. This move would enable the company to combine its expertise in molecular reagents and biomolecules with the biologic, toxicology and animal health testing, offered by Bioreliance, for drug development. Sigma Aldrich's with strong operational capabilities, and a wide range of reagents and specialized products, is focusing on emerging markets including India for increased opportunies. It is aiming for a 20 percent growth in coming few years. It is also increasing its investments in India. Currently there exist both direct and indirect partnership approaches with dealers and Sigma has more than 100 distributors to help it to expand its reach in India. | Business: Manufacture and supply of analytical, biological, chemistry products MD: Raja Ram Revenue: 147.6 crore* Start-up year:1992 Address:#12, Bommasandra-Jigani Link Road, Bangalore - 560 100, Karnataka Tel: 91-80-66219400 Website: www.sigmaaldrich.com/india ]]> <![CDATA[Profiles - DSS Imagetech]]> https://biospectrumindia.com/news/95/4492/profiles-dss-imagetech.html https://biospectrumindia.com/news/95/4492/profiles-dss-imagetech.html Mon, 16 Jul 2012 19:13:00 +0530 A giant leap for image tech DSS Imagetech has stepped into new ventures and efforts to proliferate the imaging business Starting with microscopy, DSS Imagetech expanded its product range to othe application areas such as image analysis software systems, genetic workstation, DNA probes, and microarray readers. It has now entered into the manufacturing of high-end molecular biology reagents. The company recorded an impressive growth of around 28 percent with revenues jumping to 150 crore in FY 2011-12 as compared to 116.84 crore in 2010-11. DSS initiated a joint venture with Takara Bio Inc., Japan, which resulted in the formation of DSS Takara Bio India. The new spin off company is looking at strengthening its manufacturing capabilities to offer competitive research reagent and kits suited for the local market needs. DSS Takara Bio is expected to release its first series of products by September 2012, which will pass the strict quality control parameters set up by Takara Bio Japan. Dr Ushakar Nag, director, DSS Takara Bio says, â€œWith opportunities arising out of increased research funding and the lack of manufacturing units in the country, this JV can play an important role in this direction. We plan to offer the diagnostic kits at a never seen before price in India. I hope that this JV will be able to fill the void with a focus on kits.â€? The life sciences division of the company focuses on molecular biology and molecular diagnostics. Last year, the company saw a commendable growth in its consumables business. DSS enjoys a unique position as the most informed supplier of microscopes and digital imaging solutions in the country. It entered into a collaboration with Sakura Finetek for its Micro-Imaging division. Sakura is the original manufacturer of the tissue processors, embedder, rotary microtome, and centrifuges that have become industry standards in histopathology market. DSS also tied with ibidi, a leading supplier for functional cell based assays and advanced products for cellular microscopy. DSS continues to provide training in the field of IHC, FISH and advance imaging to enable the customer to hone their experimental skills. To tap the rapidly growing medical and surgical market in India, DSS has set up its Medical Division and tied up with world leaders such as Olympus Medical Systems for the latters flexible gastroenterology and bronchoscopy products. | Business: Suppliers of clinical lab, biotech research instruments and tools CEO: Arvinder Dhingra Revenue: 150 crore Start-up year:1965 Address: A-5 Mohan Cooperative Industrial Area, New Delhi -110 044 Tel: 91-11-30886763 Website: www.dssimage.com ]]> <![CDATA[Profiles - Sartorius India]]> https://biospectrumindia.com/news/95/1076/profiles-sartorius-india.html https://biospectrumindia.com/news/95/1076/profiles-sartorius-india.html Mon, 16 Jul 2012 19:09:00 +0530 Tailor-made and reliable solutions Growing at a rate higher than the industry average of over 15%, Sartorius is now focusing on integrating its single use systems in the Indian biopharma industry Sartorius reaped rich dividends from its bioprocess division last year. The company registered 195 crore in bioscience revenue in FY 2011-12. In an effort to attract long-term growth and earnings potential, Sartorius refocused and rechristened its existing divisions to align with the market requirements. Currently it has divided its operations into three key divisions: bioprocess solutions, lab products and services, and industrial weighing. The bioprocess solutions division that grew by over 18 percent, proved to be the major driver for growth. It will continue to focus on the biopharma market. Its thrust areas are filtration, cell cultivation and purification, fluid management, fermentation and production processes. The lab products and services segment primarily manufactures laboratory instruments and consumables. Considered to be its strong domain, industrial weighing spreads across not just the biotech and pharma industries, but also encompasses weighing and control applications in the manufacturing processes of the food and chemicals. Both these divisions exhibited a double digit growth in the last financial year. Additionally, Sartorius focused on promoting its line of single-use solutions, and this proved to be the key factor behind its growth story. Sartorius has an extensive portfolio of single-use technologies in the sector and also offers integrated single-use systems. Sartorius has also expanded its integrated solutions business unit to enable it to focus more strongly on identifying projects suitable for large-scale deployment of single-use products which has been received favorably in Asian countries. The year was also marked by a number of new product launches including a new crossflow filtration system for purifying vaccines and other biologics, and a salt-tolerant membrane adsorber to purify target proteins without diluting the biopharmaceutical medium. The consumables product launches included single-use bags, plastic tubing and connectors. One of Sartorius' differentiating qualities is said to be the design of solutions specifically to the requirements of individual applications and the comprehensive technical consulting. In India, this is demonstrated by the augmentation of its validation lab facility to handle cytotoxic products for product specific validation studies. | Business: Bioprocess solutions and lab products and services MD: Amit Chatterjee Revenue: 195 crore Start-up year:1992 Address: 69/2 & 69/3, Jakkasandra, Kunigal Road, NH 48, Nelamangala, Bangalore - 562 123, Karnataka Tel: 91-80-43505248 Website: www.sartorius.com ]]> <![CDATA[Profiles - Shimadzu Analytical (India)]]> https://biospectrumindia.com/news/95/6897/profiles-shimadzu-analytical-india.html https://biospectrumindia.com/news/95/6897/profiles-shimadzu-analytical-india.html Mon, 16 Jul 2012 19:06:00 +0530 Personalized support pays dividends Since its inception in India, Shimadzu's growth graph has been consistent Shimadzu Analytical (India) focuses primarily on offering technologies in the field of analytical, scientific instrumentation and process control, and environmental monitoring. For fiscal 2011-2012, the company clocked revenue of 201 crore from its life sciences business alone. Started as a direct subsidiary in 2006, in India, Shimadzu presently has five marketing partners, namely Spinco Biotech, Toshvin Analytical, Swan Environmental, Saksham Analytical Instruments, and Amkette Analytics. Over the years, Shimadzu India has directed its efforts on investing in infrastructure development and strengthening of customer service, application support team, and training activities. The customer support center in Mumbai has been upgraded and expanded to support the latest technology. It now showcases majority of its recent releases and is fully equipped with trained staff to support these high-end instruments. Shimadzu has also launched a wide range of products in the Indian market. In Tandem mass spectrometry segment, the company saw a successful launch of LCMS-8030 triple quardupole mass spectrometer. This product was well received and accepted by the MS scientists. The company has also launched mid-range UV-VIS Spectrophotometers, TOC-4200 (a New Generation On-Line TOC Analyzer), SPM-9700 (a new model for Scanning Probe Microscope), ATX/ATY series, UV-2600/2700 (Range of Analytical balances), MOC63u (UniBloc Moisture Analyzer MOC63u), SALD-2300 (Laser Diffraction Particle Size Analyzer) and within the EZ-X Series, a new EZ Test (a Compact Tabletop Tester). In May this year, the company in India, launched the GCMS-TQ8030 (Triple Quadrupole Gas Chromatograph Mass Spectrometer) under the Ultra Fast Mass Spectrometry series, the LCMS-8040 (a new Model Triple Quadrupole Liquid Chromatograph Mass Spectrometer under the ultra Fast Mass Spectrometry series) and LCMS-8080 (a new Model Triple Quadrupole Liquid Chromatograph Mass Spectrometer under the Ultra Fast Mass Spectrometry series). â€œWe are confident to position the recently expanded UFMS series as we now have a complete MS product portfolio aiding best analytical solutions and ably backed by a strong application support team,â€? says Senya Imamichi, managing director, Shimadzu India. | Business: Manufacturer of analytical instrumentation MD: Senya Imamichi Revenue: 201 crore Start-up year:2006 Address: 1 A/B Rushabh Chambers, Makwana Road, Marol, Andheri (East), Mumbai - 400 059 Tel: 91-22-29204741 Website: www.shimadzu.in ]]> <![CDATA[Profiles - RFCL (Avantor Performance)]]> https://biospectrumindia.com/news/95/1993/profiles-rfcl-avantor-performance.html https://biospectrumindia.com/news/95/1993/profiles-rfcl-avantor-performance.html Mon, 16 Jul 2012 19:05:00 +0530 Improve product offerings, increased market presence The global experience of Avantor has enabled RFCL to record a whopping 117% growth The acquisition of RFCL by US-based Avantor Performance Materials Holdings has enabled the former to better serve existing and new customers in India, Asia and international markets. Avantor manufactures and markets high-performance chemicals and materials under several brand names, including JT Baker, Rankem, and Macron Fine Chemicals. While RFCL has benefited from the global experience of Avantor, the latter in exchange has utilized RFCL network in India to push its products into the market. For FY 2011-12, the company's revenue stood at 231.5 crore as compared to 106.7 crore in FY 2010-11. RFCL is today a provider of fine chemicals, laboratory reagents and consumables for the medical diagnostics market. According to the top management, the company intends to bring to the market more advanced products through organic development and acquisition. For future growth, the company is looking at strengthening the performance businesses (pharmacopoeial and photovoltaic) to elevate value chain offerings. The company will also make available real-time information through B2B and B2C e-CRM to retain customers. It is also looking at investments in R&D to increase business vitality. RFCL also entered into a strategic partnership with Integrated DNA Technologies, USA, for the marketing of custom nucleic acids to the Indian life science research community. The company has also made new additions to its product basket. In the portfolio of Microlife (dehydrated culture media), Rankem has added 64 products which will give wider spectrum to different application areas. Acetonitrile HPLC Gradient Gold four liter pack has been introduced for critical applications and also for the applications at lower wavelengths. In molecular biology segment, 47 products were added to the fermentation area, where the purity and accuracy is now defined at upstream process. Driven by its vision of â€œleveraging science to provide solutions for a better lifeâ€?, RFCL is aggressively building both its businesses backed by R&D, product development and manufacturing to offer value-added products and services to its target customers. The company in 2010 unveiled its new mid-term plan titled â€œSprint 2014â€? which will enable RFCL to grow at a CAGR of 23 percent for the next four years. | Business: Manufacturing and marketing of fine chemicals and lab kits Executive Vice President: Sushil Mehta Revenue: 231.5 crore Start-up year:2005 Address: 12th Floor, The Pinnacle Claridges Business Tower, Surajkund Road, Faridabad - 121 009 Tel: 91-129-4267000, 4267100 Website: www.rfcl.in ]]> <![CDATA[Profiles - Invitrogen Bioservices India]]> https://biospectrumindia.com/news/95/1019/profiles-invitrogen-bioservices-india.html https://biospectrumindia.com/news/95/1019/profiles-invitrogen-bioservices-india.html Mon, 16 Jul 2012 19:02:00 +0530 Distribution center to open new doors With the inauguration of its $3 million India Distribution Center (IDC), Invitrogen hopes to further improve supply time cycles and quickly introduce newer products Life Technologies operates in India through its subsidiary Invitrogen Bioservices. Exhibiting a robust growth of 30 percent over the previous year, Invitrogen has continued its upward trajectory as its estimated life sciences revenue for 2011-12 stood at 234 core. With its product range encompassing everything from laboratory consumables to molecular probes and instruments, Invitrogen's products are said to be found in more than 90 percent research labs in India. Over the last few years, Life Technologies is making strong inroads into the local markets by taking a few strategic steps, which included the acquisition of Applied Biosystems in late 2010. Another important step was the inauguration of its India Distribution Center (IDC) in Bangalore last year in July. This move has allowed for faster deliveries of its products to locations across India. The center spread across 25,000 sq. ft, is based on a hub and spoke model, wherein the Bangalore center will act as the primary location for the distribution services. The center will also help make available a wide range of products and specialized technologies in India. Since the company started its operations in India, there has been a four fold increase in the number of items shipped per day. The quality of distribution has also shown good progress with its order fulfillment rate going up by over 50 percent. According to Devashsis Ohri MD, Invitrogen Bioservices India, â€œThe major advantage with the start of this center has been the reduction of time cycles for the delivery of products and acceleration of the use of newer technologies.â€? Invitrogen has also pursued research projects in specialty areas, such as stem cells and bioinformatics. In one of its projects, Life Technologies and SG Biofuels, completed the sequencing of the Jatropha curcas genome to 100x coverage, using the Sold 4.0 system last year. The sequence significantly accelerated the identification of key trials for the oilseeds-producing crop. Its Ion Torrent and Ion Proton DNA sequencing platforms, based on innovative semiconductor technology, are making rapid advances in sequencing technologies. Additionally the company also has a technical and customer support team to support global markets and best-in-the-class demonstration labs where a customer can work on a wide range of technologies and equipment to get hands-on experience. | Business: Manufacturer and supplier of biotech consumables and instruments MD: Devashish Ohri Revenue: 234 crore* Address: Second Floor, First Technology Place, 3EPIP, Whitefield, Bangalore - 560 066. Tel: 91-80-41785401 Website: www.invitrogen.com ]]> <![CDATA[Profiles - Becton Dickinson]]> https://biospectrumindia.com/news/95/2620/profiles-becton-dickinson.html https://biospectrumindia.com/news/95/2620/profiles-becton-dickinson.html Mon, 16 Jul 2012 18:40:00 +0530 Creating value for future Becton Dickinson looks at tapping unexplored potential areas to provide high momentum growth for its flow cytometry business US-based Becton Dickinson (BD) operates in India through a wholly-owned subsidiary, BD India. The BD Biosciences division of the company is a leader in the flow cytometry segment capturing almost 85 percent share of the total market in India. The division is focused on improving drug therapy, enhancing the speed of diagnosing infectious diseases, and advancing research and discovery of new drugs and vaccines. The estimated revenues of the Bioscience division for FY 2011-12 was 248.4 crore which was a 20 percent sump over the revenue figure of 207 crore in the previous fiscal. Since the company caters to a very specific market, it enjoys complete monopoly over the segment of cell analysis and flow cytometry. BD's product range primarily finds its application in experimental stem cell therapy, but can also be used in nanobiotech, marine biotech, and sterile experimental stem cell therapy. The company during last 15 years has invested heavily in training and education along with building strong after sales engineering support, which has helped BD to grab majority market share. During last few years, BD has established three centers for excellence (CoE) at NCBS, Bangalore, Kolkata University and CDRI Lucknow. Besides, it also has plans to establish seven new CoEs over next five years. In March 2012, the company established a fluorescence-activated cell sorting (FACS) academy in collaboration with Jamia Hamdard University, New Delhi. The acquisition of Accuri Cytometers has helped BD to expand its presence into the emerging affordable personal flow cytometer space. The company expects the price of high-end analyzer that costs around $100k to go down by 50 percent. BD is also investing heavily in special order research product (SORP) platforms to meet customized needs. It plans to approach the sorting market with personal sorters concept and will introduce FACSJaaz range of compact cell sorters shortly in the market. According to the company, the business has multiplied 40 times in the last 15 years. The company's consumable business has grown well and it is investing in creating new market for capital instrumentation. The company foresees fast paced personal flow cytometry growing segment as an opportunity to consequently grow its consumable business. The another major driver for the growth of the company is the customized instrumentation. | Business: Supplier of diagnostic bioresearch and medical equipment Director, BD Biosciences: Sunit Trivedi Revenue: 248.4 crore* Start-up year: 1994 Address: 6th Floor, Signature Towers, B South City 1, Gurgaon-122001, Haryana Tel: 91-124-2383566 Website: www.bd.com/india ]]> <![CDATA[Profiles - HiMedia Labs]]> https://biospectrumindia.com/news/95/4415/profiles-himedia-labs.html https://biospectrumindia.com/news/95/4415/profiles-himedia-labs.html Mon, 16 Jul 2012 18:37:00 +0530 ]]> <![CDATA[Profiles - Waters India]]> https://biospectrumindia.com/news/95/6612/profiles-waters-india.html https://biospectrumindia.com/news/95/6612/profiles-waters-india.html Mon, 16 Jul 2012 18:32:00 +0530 25 years of excellence Waters has shown an overall growth of 26%, largely credited to the mass spectrometry sales Celebrating its silver jubilee in India, Waters India crossed 458.5 crore in revenues last year. Waters India is the fastest growing Waters subsidiary in the world with a growth rate of over 26 percent. The strength of Waters India lies in the fact that the company is sharply focused on the separations segment, that has allowed Waters India to maintain a leadership profile. Today, almost 70 percent of the large and medium sized pharma companies in India use a Waters' product. It has been widely credited for pioneering the ultra performance liquid chromatography (UPLC) systems worldwide. As the adoption of UPLC systems in quality control departments picks up pace, a strong growth in this segment is foreseen by Waters. Waters India announced a host of new product launches in 2011-12. Three products were introduced in the mass spectrometry segment which includes the TQD tandem quadrupole mass detector. In the UPLC segment, Waters launched UPC2/Unify system and UPC I class. Another remarkable achievement for Waters India was the first sale of its new product, UPLC Square, that was launched in India in May, just within a month of its global launch. In 2011-12, Waters India garnered a market share of 30 percent in the mass spectrometry domain. The liquid chromatograhy domain, which is considered to be company's strong area, held over 40 percent of the total market sales. In terms of allied products, Waters' signature software Empower for liquid chromatography systems, is used by thousands of scientists in India. Waters entered into a collaboration with the Tecan group to bring in better automation of routine clinical laboratory assays. By combining Tecan' s Freedom EVO liquid handling platform with Waters Acquity TQD liquid chromatography/mass spectrometer (LC/MS/MS) systems, Waters has been efficiently able to automate sample preparations. In terms of investments, Waters India has been focusing on strengthening the applications laboratory in Bangalore, which develops solutions for Indian customers. This center also caters to increasing the knowledge base of trained individuals, by providing necessary training courses. It has also initiated online ordering by opening a new order center. | Business: Supplier of analytical instruments, consumables and solutions President: K V Venugopalan Revenue: 458.5 crore Start-up year: 1986 Address: 403-404, 'B' Wing, Delphi, Hiranandani Business Park, Powai, Mumbai - 400 076, Maharashtra Tel: 91-80-28371900, 91-80-28392157 Website: www.waters.com ]]> <![CDATA[Profiles - Thermo Fisher Scientific]]> https://biospectrumindia.com/news/95/8470/profiles-thermo-fisher-scientific.html https://biospectrumindia.com/news/95/8470/profiles-thermo-fisher-scientific.html Mon, 16 Jul 2012 18:12:00 +0530 Regional growth strategy is the key Thermo Fisher Scientific has seen interesting developments in India over the past year and looks forward to make a strong foothold with the launch of new products and services Thermo Fisher Scientific today has a majority market share across segments such as mass spectrometery, gas chromatography, centrifuges, cold storage, incubators, portable material characterization to process technologies, and environmental monitoring. It is also a major supplier of laboratory chemicals (Qualigens) as well as high-quality consumables such as liquid handling pipettes and chromatography columns. Thermo has successfully integrated its recent global acquisitions in India which include Phadia, Dionex and TKA. Its biosciences revenue has increased by 28 percent as its sales stood at 598 crore in FY 2011-12 as against 467 crore in 2010-11. The company has made significant investments in building a robust infrastructure in India and on skilled talent. It has also been streamlining investments in warehousing and stock points across the country and has implemented a new ERP system across most businesses. Thermo Fisher is investing in R&D projects out of India as well as increasing its manufacturing capacity. The company has also launched a range of new products over the past year. It recently announced new launches in its chromatography and mass spectrometry portfolio. These include Thermo Scientific TSQ 8000 Triple Quadrupole GC-MS system, Trace 1300 gas chromatograph, Q Exactive Plus mass spectrometer, and Nano Drop Lite spectrophotometer. In its laboratory products business, Thermo Fisher has enhanced its presence in the controlled environment storage segment with the launch of its advanced line of Thermo Scientific Forma and Thermo Scientific Revco ultra low temperature freezers. Thermo Fisher has also enhanced its molecular biology workflow with the latest launch of three new PCRs. Thermo Fisher has witnessed an increased business from its clinical services unit in Ahmedabad which is understood to be the only MHRA-approved site in South Asia. The company recently launched Unity Lab Services. â€œWe have globally launched Unity Lab Services, which will revolutionize our customer experience by including enterprise solutions, asset management, remote services, consulting apart from our existing services such as installation, commissioning, validation services, spares support and annual or comprehensive maintenance and user training. We hope to roll out this new service brand in Asia Pacific soon,â€? says Amit Chopra, MD, VP and GM, Thermo Fisher Scientific India. | Business: Manufacturer of analytical instruments, equipment, reagents and consumables, software and services for research, analysis, discovery and specialty chemicals. MD: Amit Chopra Revenue: 598 crore Start-up year: 1998 Address: 403-404, 'B' Wing, Delphi, Hiranandani Business Park, Powai, Mumbai - 400 076, Maharashtra Tel: 91-22-67162200 Website: www.thermofisher.com ]]> <![CDATA[Biosuppliers industry clocks Rs5,324 crore]]> https://biospectrumindia.com/news/95/1498/biosuppliers-industry-clocks-rs5324-crore.html https://biospectrumindia.com/news/95/1498/biosuppliers-industry-clocks-rs5324-crore.html Mon, 16 Jul 2012 17:48:00 +0530 Depreciation of the rupee against greenback and subsequent increase in import costs pull down the growth of biosuppliers industry to 14.99% The Indian Biotech industry is one of the key demand drivers for the technology providers (biosuppliers) whose major clientele are the R&D labs and manufacturing establishments. Though the biotech industry registered 18.5 percent growth over FY 2010-11, the biosuppliers industry recorded only a 15 percent growth. The biosuppliers in 2010-11 had registered a growth of 18.93 percent, but that growth rate declined during 2011-12 to 14.99 percent and the biosuppliers industry clocked 5,324 crore in revenues as against previous year's revenue of 4,630 crore. The decline in the growth rate is attributed to depreciation of the rupee against greenback and subsequent increase in import costs. This has not only affected the overall revenues but made the market all the more competitive. The biosuppliers industry has registered a Compound Annual Growth Rate (CAGR) of 32.62 percent during 2002-2006 and in the next five year period the industry witnessed a CAGR of 11.17 percent. The biosuppliers industry has registered a CAGR of 24.61 percent for the period 2002-11. Though the biosuppliers industry has over 150 companies, multinationals have strong presence in India as they have been offering high quality products and services. The multinational companies (though less in number) account for over 73 percent of the total biosuppliers industry revenues and the rest of the revenues is generated by the local players (mainly the distributors). While most of the principal companies have been generating an average revenue of over 200 crore from the life sciences business operations in India, the local companies (mainly distributors) have been generating average revenues of 40 crore with only a handful of them generating over 100 crore. In the North, Agilent Technologies is leading the table with 365.7 crore followed by Becton Dickenson with 248.40 crore and RFCL with 231.5 crore. In the West, Thermo Fisher Scientific is leading the table with Rs 598 crore followed by local play HiMedia Laboratories with Rs 286 crore and Shimadzu Analytical with 201 crore. In the South, Waters is the leading player with 458.5 crore followed by Invitrogen Bioservices India with 234 crore and Sartorius India with 195 crore. Last year, it was observed that most government research institutions did not make any large purchases citing the lack of sufficient funds. However with greater fund allocation for research, in the 12th five year plan, the industry hopes that this trend will be reversed in the coming years. Thermo Fisher Scientific tops the list with 598 crore Waters India stands second and Agilent Technologies is the third largest technology provider in the country. Top 20 companies contribute 73 percent of the total revenues The biosuppliers industry has registered CAGR of 32.62 percent during 2002-06 and a CAGR of 11.17 percent during 2007-11. Some of the leading technology providers in the industry couldn't participate in this year's survey because of technnical and policy related issues.  Top 50 BioSuppliers 2012  Rank Company Bioscience business revenues in ( crore) % Change over 2011-12 2010-11 2009-10 2010-11 2009-10 1 Thermo Fisher Scientific 598.00 467.00 210.00 28.05% 122.38% 2 Waters India 458.50 362.52 262.20 26.48% 38.26% 3 Agilent Technologies 365.70 318.00 255.00 15.00% 24.71% 4 HiMedia Laboratories 286.00 212.00 196.00 34.91% 8.16% 5 Becton Dickenson 248.40 207.00 180.00 20.00% 15.00% 6 Invitrogen Bioservices India 234.00 180.00 139.13 30.00% 29.38% 7 RFCL (Avantor Performance Materials) 231.50 106.70 93.23 116.96% 14.45% 8 Shimadzu Analytical India 201.00 186.00 141.00 8.06% 31.91% 9 Sartorius India 195.00 166.05 145.00 17.43% 14.52% 10 Imperial Life Sciences 152.70 135.10 112.85 13.03% 19.72% 11 DSS Imagetech 150.00 116.84 88.08 28.38% 32.65% 12 Sigma Aldrich Chemicals 147.60 123.00 100.00 20.00% 23.00% 13 West Pharmaceutical Services 124.00 91.18 - 35.99% - 14 Eppendorf India 102.66 90.80 73.63 13.06% 23.32% 15 Toshvin Analytical 100.45 89.70 85.10 11.98% 5.41% 16 Advanced Microdevices 85.00 68.00 56.00 25.00% 21.43% 17 Towa Optics 74.29 73.68 64.91 0.83% 13.51% 18 MediSpec India 69.16 58.38 43.24 18.47% 35.01% 19 Adam Fabriwerk 50.00 42.00 - - - 20 Nilsan-Nishotech 39.00 30.00 20.00 30.00% 50.00% 21 Genaxy Scientific 34.00 32.50 31.50 4.62% 3.17% 22 Techcomp India 30.00 23.00 15.00 30.43% 53.33% 23 Ultra Group 30.00 - - - - 24 Biotron Healthcare 27.10 21.35 18.50 26.93% 15.41% 25 Syktech Systems 27.00 22.50 18.00 20.00% 25.00% 26 Biodigital 26.00 24.00 27.00 8.33% -11.11% 27 Biogentek BG 26.00 23.00 - 13.04% - 28 Premas Biotech 25.82 27.70 - -6.79% - 29 BI Biotech 21.05 16.71 14.04 25.97% 19.02% 30 Saksham Technologies 19.23 14.00 15.00 37.36% -6.67% 31 Sisco Research Laboratories 18.46 15.00 5.30 23.07% 183.02% 32 Gordhandas Desai 18.00 - - - - 33 Anton Paar India 15.00 10.00 50.00% - 34 Krishgen 15.00 - - - - 35 Pharmalab India 15.00 16.00 19.80 -6.25% -19.19% 36 Trident Equipments 14.85 13.50 13.50 10.00% 0.00% 37 Esco Biotech 14.74 13.10 10.70 12.52% 22.43% 38 Biohouse solutions 13.22 10.11 7.00 30.76% 44.43% 39 Cryogen Instruments 12.00 10.00 20.00% -- 40 JH Bio Innovations 12.00 11.00 10.90 9.09% 0.92% 41 Axiom Biotek 9.80 7.60 28.95% -- 42 Chromous Biotech 7.50 5.50 5.02 36.36% 9.56% 43 Raj Analytical Services 7.00 4.00 -- 75.00% -- 44 Marsap 5.90 4.50 5.30 31.11% -15.09% 45 Future Bioscience 5.00 4.40 3.50 13.64% 25.71% 46 Bio-Age Equipment & Services 3.05 2.95 2.85 3.39% 3.51% 47 Tecpharma Systems 2.50 9.50 6.00 -73.68% 58.33% 48 Advanced Technologies 1.95 - - - - 49 Sangama Scientific 0.69 - - - - 50 3B BlackBio Biotech India 0.46 - - - - ]]> <![CDATA[Expert Opinion - VL Ramprasad]]> https://biospectrumindia.com/news/95/2911/expert-opinion-vl-ramprasad.html https://biospectrumindia.com/news/95/2911/expert-opinion-vl-ramprasad.html Mon, 16 Jul 2012 17:38:00 +0530 HIGH THROUGHPUT GENOMICS NGS penetrating different segments Though the NGS market in India is encouraging, it is yet to take stride because of long funding cycles and slow adaptability of the researchers to this technology Decoding the DNA is imperative for all the branches of biology. Discovery of capillary electrophoresis (CE) based Sanger sequencing made scientists to unravel the genetic information from any biological system. This technology has been widely adopted in many laboratories around the world, but was always hindered by the inherent limitations in throughput, scalability, speed, resolution and most importantly the cost. To overcome these barriers an entirely new technology was evolved and was called â€“ Next Generation Sequencing (NGS). Market overview Next generation sequencers are penetrating into the services providing sector to become the critical tools in Biomedical and BioAgri research. Recent scientific discoveries that are an outcome of next generation sequencing technology show the impact of massively parallel platforms. The declining cost of genomic sequencing has shown a way for the clinical application of this technology. The tremendous growth in drug discovery and molecular diagnostics will promote the uptake of this technology. BioAgri industry is also bullish on NGS. The worldwide market for sequencing products will grow from an estimated $1.3 billion in 2010 to more than $3.3 billion by 2015, a compound annual growth rate (CAGR) of 20.5 percent over the next five years. Even though the NGS market in India is encouraging, it is yet to take the similar growth stride that other APAC countries such as Australia, China, and Korea have taken, and this could be because of long- funding cycles and slow-adaptability of the researchers to this technology. The current Indian NGS market is valued at 70-75 crore that includes instruments (including the desktop NGS), reagents, and services. The three main players in the Indian market are Illumina (GAIIx, Hiseq), Life Technologies (SOLiD/Ion Torrent) and Roche-454 (FLX/FLX junior). Illumina Hiseq systems deliver the highest data output (300Gb on Hiseq 1000 and 600Gb on Hiseq 2000) among all the available technologies. There are about 42-45 NGS installations (excluding the desktop next gen sequencers) in India. Illumina is the market leader with more than 40 percent market share and also dominates North and South India with more than 60 percent market share. Roche and Life Technologies share equal market share in East and West India. Scientific publications from India using NGS technology has been slowly increasing, so far there are about 10-15 publications and most of them have used Illumina GAIIx or Roche 454 to generate the published data. The major factors driving the NGS market include the decrease in the cost of sequencing with increase in the number of applications of sequencing, in various fields of science such as cancer research, agricultural, biofuels, marine sciences, livestock research, and veterinary research. Thus, there is more demand for the equipment to understand the genome sequencing and utilize it further for human and environmental benefits. The high pace of NGS research is likely to boost the market for personal genome sequencing in the coming years. Manufacturers predominantly have an inclination towards diagnostic applications both as a supplier and manufacturer. Personal (desktop) NGS market There have been more interesting developments from the established NGS technologies such as the launch of personal benchtop NGS instruments like the new MiSeq from Illumina, which generates 2-7GB of data and is a direct challenge to Ion Torrent (10MB-1GB), as well as the Roche 454 Jr (35-40MB). These desktop sequencers require less financial commitment and usually require only one grant to fund. In contrast, the big boxes require a massive financial commitment to purchase and operate.The best analogy would be the personal computer (PC) revolution largely replacing the need for mainframes. Life Technologies' Ion Torrent and Roche 454 Jr had the early mover advantage as they entered the market (shipping) beginning from 2011, whereas Illumina started shipping Miseq systems at the end of 2011. Accounting for the free or reagent rental installations, the desktop NGS market is dominated by Ion Torrent, followed by Illumina and Roche systems. While Ion Torrent gives formidable competition to Illumina, as per Goldman Sachs business report, by next year Illumina MiSeq system will begin exerting its dominance. By placements, MiSeq will have an estimated 57 percent market share, compared to 43 percent for PGM, and by revenue Illumina's platform will generate three times as much as Ion Torrent's. This neck-to-neck competition and affordable costs of all three Desktop sequencer technologies will push the biotech industry to be more innovative and cost effective and the users will enjoy the benefits of this healthy competition. Drivers for NGS market The decrease of price of the tests being conducted results in increased reagent usage. Similarly, this technology is replacing the microarray technology and currently many institutes prefer NGS platforms over microarrays. Future of sequencing Certainly, one of the complications arising from the deluge of the sequencing data is managing, analyzing, validating, and interpreting the data. The future of sequencing depends a lot on the informatics solutions that reduce the bioinformatic costs, facilitate the data analysis, and makes it simple for the users to interpret the results. The highest capacity instruments currently available require 8â€“14 days to produce nearly 300-600 GB of data. Apart from the current market leaders, few other interesting technologies like the single molecule realtime sequencing (SMRT) from Pacific Biosciences that is being tested in early access sites, monitors each one of an array of individual polymerases while DNA synthesis is occurring, in order to obtain the single molecule sequences in less than 30 minutes. Other instruments in development, including those by Oxford Nanopore, use nanopore technology to identify individual DNA nucleotides as the DNA fragment passes through the nanopore, by non-fluorescent detection approaches. Although the current capacities of realtime sequencers are not enough for whole genome sequencing of large genomes in a single run, the near-term application of these instruments could be on focused evaluation of specific genes or small genomes.  High Throughput NGS installations in India   Technology/Vendor Installations in 2011 Total installations Illumina (GAIIx, Hiseq, HiScanSQ) 5 17 Roche (Roche 454) 3 16 Life Technologies (SOLid) 4 10 Pacific Biosystems 0 0 Next Generation Sequencing market has a value of $16million - Dr VL Ramprasad, chief scientist, Spinco Biotech Dr Ramprasad was previously working as senior scientist at Vision Research Foundation, Sankara Nethralaya, Chennai. He holds a Masters and PhD degree in Human Genetics from Birla Institute of Technology and Science, Pilani and has 16 international peer reviewed publications. ]]> <![CDATA[Expert Opinion - Vivek Dhyani]]> https://biospectrumindia.com/news/95/2095/expert-opinion-vivek-dhyani.html https://biospectrumindia.com/news/95/2095/expert-opinion-vivek-dhyani.html Mon, 16 Jul 2012 17:37:00 +0530 GC & GC-MS Analytical industry growing at rate of 10% India is one of the fastest growing economies and the demand for sophisticated instrument has been increasing Analytical Industry in India is pegged at more than 6,000 crore and is growing at a healthy rate of approximately 10 percent annually. The driver for this growth rate is the growing Indian economy and stringent hygiene standards, rapid economic growth and the competitive environment, stringent government regulations for environment, food safety and drugs and overseas market regulations in pharma, food and materials. The growth is in all the sectors including life science sector, government institutes, research and academia, environment (various pollution control boards), forensic (forensic science laboratories, homeland security), commercial testing labs, food, flavor and fragrance industry, infrastructure industry and defense. The major chunk of analytical business is contributed by chromatography and spectroscopy instruments. Chromatography accounts for more than 20 percent share in the analytical instrumentation market and this trend is almost similar to the worldwide market. Liquid chromatography (LC) and gas chromatography (GC) are the most popular analytical technique and both accounts for almost 1,200 crore of business in India. The chromatography field has witnessed an excellent growth rate of more than 25 percent. The GC-MS market is dominated by single quadrapole mass spectrometer and the reason for that is its simple operation, strong library support added with sensitivity and selectivity. The market of single quadrapole GC-MS systems is around 75 percent followed by ion trap and triple quadrapole sytems. Market share India is one of the fastest growing economies in the world and the demand for sophisticated instrument has been increasing. The total GC-MS instrument sold in FY 2011 is expected to be around 230 and the market is growing at an annual rate of 15 percent. The major players in GC-MS market are Agilent, Perkin Elmer, Shimadzu, and Thermo. Agilent with GC-Single quadrapole, Ion trap, Triple quadrapole and Q-ToF is the market leader followed by Shimadzu having GC single quadrapole and Thermo having GC -Single quadrapole, Ion trap, Triple quadrapole (QQQ) and HRMS. Waters is having presence in GC-QQQ, ToF and HRMS market and Leco in GC-ToF and HRMS market. In pharma sector, the demand is more for single quadrapole MS as the matrix effect is minimum because of the use of headspace sampler. In non-pharma sector, especially in the field of residual analysis, like pesticides in food, the inclination is more towards the Ion trap and QQQ because of selectivity, high sensitivity and speed. The demand for QQQ is expected to grow strongly in the future because of more stringent laws being implemented in food, drugs and nutrition by government of India for domestic consumption. Similarly, the importing countries are also putting more stringent regulations to regulate import and there is requirement of testing samples for more numbers of analytes. The detection level desired is also at very trace level. All these factors are fuelling the growth of GC-QQQ market in India. The TOF and HRMS are the other technologies which are slowly gaining popularity and have their own niche market. Continued investment in the R & D sector by industries and a good support by the government and better funding for research and academia is going to help the growth of Mass spectrometry market in India. Future trends India has come a long way from a primitive market for analytical industry to one of the biggest and fastest growing one. Government of India is also giving lot of impetus on growth of technologies and there is healthy flow of funding for setting up state-of-the-art laboratory in academic and research field. Today, gas chromatography and mass spectrometry are not limited to just few labs but have become a routine tool for various analyses. More and more labs are turning toward the high end GC mass spectrometry and this trend will continue in the near future.  GC MS Market share   Company % share Agilent Technologies 45 Shimadzu 29 Thermo Fischer 14 Perkin Elmer 7 Others 5 Next Generation Sequencing market has a value of $16million - Vivek Dhyani, product manager, GCMS, Agilent Technologies Vivek Dhyani is also the lead manager for thermal desorption system at Agilent Technologies in India. He has more than 11 years of experience in the chromatography field and before joining Agilent has worked with Perkin Elmer, Labindia, Zydus Nycomed and Searle India in various positions. He is a regular guest lecturer in reputed institute such as NIPER, Chandigarh. Acknowledgement Some of the data's have been sourced from SDI instrument business outlook and Global Assessment Report. Thanks to Dr. Upendra Khurana, Buissness Manager-Mass spec, Agilent India for helping and editing this article. Thanks to Dheeraj Vig, Marketing Program Manager for giving inputs on market trend and Market Share. ]]> <![CDATA[Expert Opinion - Dr Gopal Vaidyanathan]]> https://biospectrumindia.com/news/95/1436/expert-opinion-dr-gopal-vaidyanathan.html https://biospectrumindia.com/news/95/1436/expert-opinion-dr-gopal-vaidyanathan.html Mon, 16 Jul 2012 17:36:00 +0530 MASS SPECTROMETRY Mass spectrometry market growing at 17% The demand for mass spectrometers in the major industries catering to life sciences is primarily responsible for the growth of MS business in India Mass spectrometry (MS) has evolved from being a primarily research tool utilized for measuring the molecular weight of synthetic compounds and natural products to one that can be used in various industrial segments such as pharmaceuticals, biotech, food safety, chemical analysis and clinical applications. The first few tandem quadrupole liquid chromatography with Tandem Mass Spectrometry Detection (LCMSMS) systems came during mid 1990's into the R&D divisions of pharmaceutical companies. The potential of the triple quadrupoles was quickly recognized in bioanalytical studies and a number of CROs set up their regulated bioanalytical laboratories with LCMSMS systems for conducting bioequivalence studies to support the generic pharmaceutical market from India as well as Europe and US. From 2000 onwards, European Union strictly implemented the monitoring of toxic chemical residual levels such as pesticides, antibiotics in food stuffs and dyes and other chemicals in textile, leather with MRL and MRPL limits. To meet the EU norms, many testing laboratories including government labs in India had to equip with modern technologies such as gas chromatographyâ€“mass spectrometry (GC-MS), LCMSMS and inductively coupled plasma mass spectrometry (ICP-MS) which also increased the adoption of tandem quadrupole MS technologies. There are several hundred tandem quadrupoles in the country at present in most of the academic and industrial institutes catering to a wide variety of applications. The past decade has seen a rapid increase in the number of high resolution mass spectrometers (HRMS) for both small molecule and biological applications in the research institutes as well as in the pharmaceutical industry. The environmental and food safety industry is also using the HRMS instruments for nonâ€“targeted screening for pollutants, contaminants and pesticides at trace levels. The generic Indian pharmaceutical has adopted the high resolution mass spectrometers for impurity profiling, leachables and extractables studies in the past few years. The mass spectrometry market is currently projected to be $45-50 million on an annual basis. The market for mass spectrometry has grown at about 17 percent over the past five years according to SDI reports. The fastest growth was in the tandem quadrupole business at about 27 percent. The high HRMS instruments (mainly QToFs) have also shown good growth from 2006 to 2011. The single quad market has almost doubled during this period. The pharmaceutical industry and the CROs are the major drivers for this growth. As per SDI report, the demand for mass spectrometers in the major industries catering to life sciences is primarily responsible for the growth of MS business in India. As the demand for instrumentation in life sciences is high, academia, pharmaceutical and biotech sector combined for the major functional demand. The tandem quads market is driven by quantitative applications in pharmaceutical, CROs and food testing agencies. We are adding around 100 tandem quadrupoles every year and about 25 to 30 HRMS instruments. The quadrupole and the high resolution MS markets are expected to grow in the coming years. The ability of the QToF technology to combine well with ultra high performance chromatography and conduct qualitative and quantitative analysis in the single run has made a significant contribution to enhance the productivity and is gaining increased acceptance in various application segments. Most of the leading mass spectrometer companies have also established applications laboratories in India for conducting demos, training and applications development. The current projections indicate that mass spectrometry will show a double digit growth in the coming years. MS technology has made significant contributions to the characterization of biological and its role is going to become even more important in the future.  List of industries using MS  Industry Demand (%) Academia 32 Pharmaceuticals 24 Biotechnology 15 Contract Research Organisation 9 Government Research 9 Hospital 4 Government Research 2 Agricultural / Food 1 General / Environmental 1 Chemicals & Others 3 MS market is projected at $45-50 million - Dr Gopal Vaidyanathan, Vice President â€“ Mass Spectrometry Operations, Waters India Dr Gopal Vaidyanathan has worked with Ranbaxy Research Laboratories, Lambda Therapeutic Research, Dr. Reddy's Research Laboratories and Advinus Therapeutics before joining Waters in January 2008. In addition to chromatography and mass spectrometry, his research interests include structural characterization, solid state characterisation and bioanalysis. ]]> <![CDATA[Expert Opinion - Uma Raghuram]]> https://biospectrumindia.com/news/95/3924/expert-opinion-uma-raghuram.html https://biospectrumindia.com/news/95/3924/expert-opinion-uma-raghuram.html Mon, 16 Jul 2012 17:34:00 +0530 ELECTROPHORESIS Capitalizing on multi-dimensional services Demand for electrophoresis is expected to rise as the drug discovery programs in India gain momentum due to several drugs nearing patent expiry Ask any Mumbaikar for a particular address and rest assured, you would be given a list of easily recognizable landmarks first and then directions on how to reach the place. So also for me, a column on electrophoresis market trends in India means first an analogy which I can relate to, and from there to the subject. The Mumbai autorickshaws compare very well with electrophoresis - what with its size and shape being just right to wind its way through the snarling traffic, its CNG fitting boasting of an eco-friendly respite to the polluted city and also claiming to be purse-polite, while the driver himself with his experience of the lanes and by-lanes can ensure that you reach your destination, even when you give up telling yourself that you were lost! And what is more, it is in synchrony with modern information technology, with the most recent one being that the auto drivers could be employed to provide information on the traffic situation within the city! So is the scenario for electrophoresis, which is an integral part of almost every facet of research, whether it is molecular biology, genetics, microbiology and biochemistry, forensics or drug discovery. It is available in different sizes and shapes to address lab space constraints, fit all kinds of budgets, applications and with scope to accommodate the ever-changing applications; not to mention the very many market players. Current market scenario The electrophoresis market is highly divided due to the inherent fragmented product portfolio that it encompasses. As a result, there are companies selling gel documentation and imaging systems, blotting units, power supplies and gels. The two major players are GE Healthcare and Bio-Rad, accounting for more than 50 percent of the market share, though this is a hazy picture as Hoefer, a global manufacturer of innovative electrophoresis instruments and consumables, not only sells its products directly and through distributors, but also through partnership with GE Healthcare. Invitrogen comes at the third position with 11 percent share and Sigma Aldrich has of six percent share. There are other key and niche players such as Agilent Technologies, Beckman Coulter, CBS Scientific, Dionex, Helena Laboratories, Lonza Group, Sebia, SERVA Electrophoresis, and Thermo Fisher Scientific. This is further compounded by the very many local suppliers and manufacturers of electrophoresis in the country like Bangalore Genei, Biomate, Genetix, Imperial Life Sciences, Suyog Diagnostics, Wheecon, and 25 or more such players. Though there is no data available for the Indian electrophoresis market, one can arrive at approximations for the last year and these include the entire paraphernalia of the electrophoresis market, meaning the routine electrophoresis boxes, power packs, blotters, capillary electrophoresis systems, and related consumables. Therefore, electrophoresis market in India for 1-D and 2-D applications is roughly estimated at $6.5 million, while that for capillary should be around $4.1 million. Of this, GE and Bio-Rad together make up $3.5 million, while Invitrogen is at $0.8 million and Sigma Aldrich at $0.4 million and Hoefer at $0.35 million (again approximate figures), while Labnet, Major Sciences, Bangalore Genei and other local players account for the rest. The growth this year is expected to be 20 percent, meaning an overall figure of $12.72 million for electrophoresis in India. Market segments The electrophoresis market can be broadly divided into three segments: gel electrophoresis including the electrophoresis boxes such as blotters, gradient makers, power supplies, gel imaging systems, capillary electrophoresis, and electrophoresis gels and reagents. The electrophoresis demand broadly comprises of 29 percent of DNA electrophoresis systems and the remaining 71 percent of protein electrophoresis. However, the trend gets to be more complex if one were to split the demand depending on the industry it caters to. For instance, according to the Global Assessment Report 10.5, biotech and government research contribute to approximately 32 percent of the demand, followed by pharmaceutical labs at nine percent, while government testing labs are at eight percent, trailing ahead of agriculture and food and contract research organizations at seven percent and six percent respectively. Another approach of following the electrophoresis demand trend would be on the basis of functions it serves - as per this report - basic research and applied R&D have the biggest demand at 55 percent, while analytical services stands at 18 percent, followed by quality assurance and control and methods development at eight percent and six percent respectively. Not included here are the teaching labs which are the highest consumers of 1-D electrophoresis reagents. Opportunities and growth drivers The recent elevated need for faster and economical ways to produce drugs for the pharmaceutical industry through proteomics, genomics, and synthetic chemistry research, has paved the way for biotechnology instrumentation. Growth is envisaged in almost all sectors pertaining to these areas of research and with the thrust on copy biologics and India's own preparedness in biosimilars; one can be rest assured of an increasing demand for electrophoresis. As the drug discovery programs in India gain momentum due to several drugs nearing patent expiry, the simplicity and robustness of protein electrophoresis platform provide researchers a concrete tool to accelerate such drug discovery experiments. Not lagging behind is the diagnostics scene, where we have kits specially designed for capillary electrophoresis; with the most noteworthy being the HbA1c glycosylated fraction of haemoglobin. A Chennai-based company, Trivitron healthcare joins hands with Sebia to launch HbA1c kit. Owing to cost-cutting demands to be competitive, attention is being focused on developing rapid and low analyte consumption systems such as those employing both separations and micro-fluidics technology. Much of this is based on innovations in electrophoretic separations exploiting electro-kinetic properties of analytes resulting in the burgeoning popularity of capillary electrophoresis. The large installed base of users ensure that protein electrophoresis will continue to play a prominent role in molecular biology experiments, with emphasis on the development of newer imaging methodologies. Techniques such as 2-DE, that expand upon the fundamental principles of electrophoresis are also likely to be growth drivers. Electrophoresis market is growing steadily at 20% - Dr Uma Raghuram, senior applications scientist and regional manager-west, Spinco Biotech Uma Raghuram has a masters in microbiology from Mumbai University and Ph.D from Anna University. She started her career in research at USV Ltd in the cell biology division, following which she joined Amersham Biosciences accepting a dual responsibility of applications and sales in lifesciences. She continued with GE Healthcare for the next seven years in various capacities. She has a few international publications, which adds to her credit. ]]> <![CDATA[Expert Opinion - Manoj Kantak]]> https://biospectrumindia.com/news/95/1586/expert-opinion-manoj-kantak.html https://biospectrumindia.com/news/95/1586/expert-opinion-manoj-kantak.html Mon, 16 Jul 2012 17:26:00 +0530 SPECTROSCOPY Catering diverse market requisites The demand for UV-Vis-NIR Spectroscopy instruments in India is estimated at 2,000 units per annum and is valued around $18 million Spectroscopy is the study of interaction between matter and radiated energy. Ultraviolet-Visible (UV-Vis) spectroscopy is routinely used in analytical chemistry for the quantitative determination of different analytes such as transition metal ions, highly conjugated organic compounds and biological macromolecules. Near InfraRed (NIR) Spectroscopy is a spectroscopic method that uses the near infra red region of the electromagnetic spectrum (from around 800 nm - 2500 nm). Typical applications include pharmaceuticals, medical diagnostics, food and agrochemical quality control etc. Today UV-Vis and UV-Vis-NIR spectrometers are used for a variety of applications. It can range from a simple purity or assay measurement to more complex applications related to biological research and material science applications. The leading manufacturers of UV-Vis and UV-Vis-NIR spectrophotometers have models ranging for the micro volume (single drop) models to the large sample size spectrophotometers for silicon wafers and flat panel displays. UV market dynamics The current demand for UV-Vis-NIR spectroscopy instruments in India is estimated at 2,000 units per annum and valued at $18 million. This includes a full range, from low-end visible spectrophotometers, spectrophotometers for water analysis to the high-end research based UV-Vis-NIR spectrohotometers and suppied by the Indian and imported brands. The UV spectroscopy market is expected to grow at 10 percent annually. The application demands clearly divide the UV markets for the local and international brands from the local brands catering to the routine colorimetric requirements and the imported brands to the regulatory and research requirements. The leading names in imported category include Agilent (formerly Varian); Jasco, Perkin Elmer, Shimadzu, and Thermo Fischer Scientific, and in the local brands the names include Chemito (now part of Thermo Fischer), Elico, Labindia, and Systronics. Over the years, a UV spectrophotometer has become a commodity item in any lab and is currently considered one of the start-up instruments. UV finds a place in laboratories across market segments including colleges and universities, diagnostic labs, industry segments such as pharma, chemicals, sugar industry, distilleries, testing labs, government labs, and research institutes. The application requirements too are quite varied from basic colorimetric analysis to highly regulatory pharmaceutical needs to advanced research in new avenues of solar energy research, and micro-volume life science requirements. Analytical instrumentation is growing steadily mainly because of increased R&D focus and quality consciousness. This momentum in growth is a direct result of demands from a fast progressing pharmaceutical and life science sectors coupled with demands from chemical, petrochemical, environmental and food industries to name a few. UV spectroscopy market to grow at 10% - Manoj Kantak, executive director, Toshvin Analytical Manoj started his career in Toshniwal Group as a service engineer and continued in analytical instruments servicing for 8 years before shifting to sales. With total experience of over 22 years in analytical instruments industry he has been closely involved in developing the Shimadzu business in India. ]]> <![CDATA[India's biosimilars guidelines is an industry booster]]> https://biospectrumindia.com/news/95/2718/indias-biosimilars-guidelines-is-an-industry-booster.html https://biospectrumindia.com/news/95/2718/indias-biosimilars-guidelines-is-an-industry-booster.html Mon, 16 Jul 2012 15:42:00 +0530 The much-awaited guidelines on which similar biologics, or what the rest of the world calls biosimilars, can be successfully manufactured and distributed in the country, has been made public. The Department of Biotechnology (DBT) secretary, Dr MK Bhan, made this a global event as he unveiled the guidelines in front of world media at the world's largest biotechnology event, BIO in Boston on June 19, 2012. Prepared jointly by scientists, regulators and industry representatives, the Guidelines on Similar Biologics: Regulatory Requirements for Marketing Authorization in India, the report is product of painstaking efforts by a committee co-chaired by the drug regulator, Dr G N Singh and eminent scientist, Dr V P Kamboj. Essentially, India's entrepreneurs can develop similar biologics against an authorized reference biologic that has been approved using a complete data package in India. More interestingly, the reference biologic should have been licensed and marketed for at least four years with significant safety and efficacy data. There is a also a clause that insists that the reference biologics should have been approved in one of the top developed countries. This is just to ensure that the product has already gone through an intensive regulatory process in one of the advanced nations. Also, the demonstration of similarity depends upon detailed and comprehensive product characterization, preclinical and clinical studies carried out in comparison with a reference biologic. Though the guidelines were prepared in consultation with various biotech stakeholders, this will not be cast in stone, according to Dr Bhan. In fact, Dr Bhan has promised that a review of the guidelines will be done a year later from now incorporating the inputs from the entire biotech community. This is a commendable step and BioSpectrum will take the lead to organize wide ranging industry-wide consultations on the guidelines in the next few months and ensure that all the industry concerns are addressed during the next review process. These guidelines have come at the right time as there is a strong realization with the industry and policy makers that a huge opportunity awaits India in the biomanufacturing space if the cards are played right. The global software icon turned healthcare evangelist, Mr Bill Gates of Microsoft fame has just gone back after praising the vaccine manufacturing capabilities of India's No. 1 biotech company, Serum Institute of India. Serum has demonstrated to the world that it can hold its head high in the highly sophisticated field of vaccine manufacturing. A vaccine-like opportunity awaits the nation on making itself a global hub for biological manufacturing. India currently accounts for only an insignificant 1.4 percent share of the global annual similar biologics manufacturing market of $138 billion. With right policies, infrastructure and investments in innovation, Indian organizations can garner reasonable share of this segment, dominated by global companies. â€œHow can India become a global manufacturing hub for biopharmaceuticals?â€?, pg. 104, is a special report that highlights the ingredients required to make this happen fast. Narayanan Suresh Chief Editor sureshn@cybermedia.co.in ]]> <![CDATA[Industrial Biotechnology: witnesses 11.2% growth]]> https://biospectrumindia.com/news/95/2916/industrial-biotechnology-witnesses-11-2-growth.html https://biospectrumindia.com/news/95/2916/industrial-biotechnology-witnesses-11-2-growth.html Wed, 27 Jun 2012 15:45:00 +0530 The Indian bioindustrial sector registered a 11.2 percent growth in its revenues with total sales of 697 crore. This increase in enzymes consumption is attributed to the rise in demand from the food, pharmaceutical, detergent, and energy sectors. The Indian market is spearheaded by global leaders such as Novozymes South Asia, Danisco (India), DSM Nutritional Products India, and Chr. Hansen (India). Besides, there are many domestic enzyme manufacturers, such as Advanced Enzymes, Lumis, Maps and Anthem. High R&D capital, unclear regulations, and an import-dominated market are some of the reasons leading to fewer domestic participants in the food and beverages sector. Indian industrial enzymes market is at various stages of growth, ranging from penetration to product development. The pharmaceutical enzymes segment is relatively nascent and is the focus of a small group of specialized manufacturers. Meanwhile, the textile and leather enzyme segments are mature, while the detergent enzymes segment is in the growth stage. The multinationals contribute about 65 percent of the market while the rest is met by the local players. However, the share of local players has been increasing over the last three-four years as these companies realize the huge potential of food enzymes. The companies are enhancing their R&D facilities and staff, establishing manufacturing plants, and a comprehensive distribution network. In addition to importing enzymes for different purposes, India also exports enzymes. The domestic consumption of enzymes for 2011-12 stood at about 527 crore, while the exports raked 170 crore in revenues during the period. The enzymes sector in India has been growing at about 11.47 percent in the last 10 years and is expected to see a growth of 11.17 percent in 2012-13.  Top 5 BioIndustrial Companies  Rank Company Region Revenue in crore % Change over 2011-12 2010-11 2009-10 2010-11 2009-10 1 Novozymes South Asia* South 297.66 242 224 23 8.04 2 Advanced Enzymes West 180 154 121 16.88 27.27 3 Rossari Biotech* West 79.2 72 55.38 10 30.01 4 Maps (India) West 58 48 - 20.83 - 5 Titan Biotech North 22.52 18.69 16.095 20.49 16.12 ]]> <![CDATA[BioServices registers 15.5% growth]]> https://biospectrumindia.com/news/95/1821/bioservices-registers-15-5-growth.html https://biospectrumindia.com/news/95/1821/bioservices-registers-15-5-growth.html Wed, 27 Jun 2012 15:42:00 +0530 The BioServices sector witnessed a growth of 15.5 percent in 2011-12 in spite of facing many issues from the regulatory agencies. The sector touched a revenue of 3,749 crore as against last year's revenue of 3,246 crore. The drop in the growth rate over previous year's growth rate was attributed to the delays in getting approvals from the Drug Controller General of India (DCGI) by the clinical research organizations (CROs). There were fewer projects that came to India as compared to previous years. The clinical research and trials sector witnessed a drop in revenue from exports by about six percent over previous year as most of the sponsors took a wait and watch approach because of prevailing regulatory concerns in the country. This drop has affected the local small and medium CROs. The leading multinational CROs in India such as Quintiles, on the contrary maintained steady growth because of its full service offerings to the local as well as global customers. In all, about 86 percent of the revenue comes from exports, while the rest is from the domestic market. The domestic business has been on the rise as India's leading pharmaceutical and biotechnology companies now have reached a stage where they are looking at conducting trials for their range of pipeline products in different therapeutic areas. The contract research business however, has continued to do well as the leading CROs continued to get business from the existing customers. India's leading players in contract research area maintained a good customer base, that helped them to maintain a decent growth during last year. There are over 115 clinical trial and contract research companies operating in India mainly based out of Bangalore, Mumbai, Hyderabad, and Ahmedabad. These companies have been offering all kind of services to sponsors. About 10 percent of the companies are having revenue of over 200 crore. Over 60 percent of the companies are doing businesses in the range between 50-100 crore and about 20 percent of the companies are operating with a revenue of less than 50 crore. Indian CROs such as Synchron, Siro Clinpharm, Veeda Clinical Research, Ecron Acunova have already expanded their operations outside India mainly European region and South East Asian region and are continuously scouting for such opportunities. At the same time all the Top 10 global CROs have established their base in India. In the clinical research space, companies have been focusing mainly on five therapy areas: cancer, metabolic diseases, diabetes, cardiovascular diseases and central nervous system. According to clinicaltrials.gov (a service of the US National Institute of Health), India has closed 1,402 studies, with 230 studies having results and remaining 1,172 studies without results. India has 434 open global studies. India has about just over 2,000 investigators overseeing the clinical trials across the country. India needs to have an additional 20-30 percent investigators for speedy approval of the clinical trial applications. With large CROs entering long-term contracts with pharmaceutical companies globally, market consolidation is on rise, leading to a more fierce competition among the mid-sized and small CROs for both resources as well as studies. The BioServices market which has registered CAGR of over 52 percent during mid 2000 has recorded CAGR of 20 percent in the last five years. It will maintain a growth rate of 18.99 percent in the coming year. On the contract research side, the research services business will continue to grow as more big pharma companies close their research and look for small biotech companies with development candidates.  Top 20 BioServices Companies  Sl.No. Company Revenue in crore % Change over 2011-12 2010-11 2009-10 2010-11 2009-10 1 Quintiles India* 572.00 476.25 375.00 20.10 27.00 2 TCG Life Sciences 500.00 - - - - 3 Syngene International 410.00 318.00 252.00 28.93 26.19 4 Fortis Clinical Research 287.00 86.00 - 233.72 -- 5 Siro Clinpharm* 282.80 202.00 150.00 40.00 34.67 6 Jubilant Life Sciences* 244.00 210.00 249.30 16.19 -15.76 7 Suven Life Sciences 203.82 152.22 - 33.90 - 8 Ecron Acunova 146.00 117.00 97.00 24.79 20.62 9 Veeda Clinical Research 135.00 120.00 112.00 12.50 7.14 10 Anthem Biosciences 100.20 78.00 53.00 28.46 47.17 11 Advinus* 90.00 - - - - 12 Vimta Labs 87.34 95.70 88.42 -8.74 8.23 13 Max Neeman International 54.66 46.17 40.00 18.39 15.42 14 Semler Research India 26.08 19.04 3.80 36.97 401.05 15 Celestial Biolabs 20.58 25.22 24.62 -18.40 2.44 16 Synchron Research Services 20.00 63.00 57.00 -68.25 10.53 17 Auriga Research 15.00 8.00 - 87.50 - 18 RCC Labs 14.00 12.00 - 16.67 - 19 Dabur Research Foundation* 5.37 - - - - 20 Polyclone BioServices 2.50 4.00 - -37.50 - *Estimates ]]> <![CDATA[Bioinformatics on growth trajectory]]> https://biospectrumindia.com/news/95/2754/bioinformatics-on-growth-trajectory.html https://biospectrumindia.com/news/95/2754/bioinformatics-on-growth-trajectory.html Wed, 27 Jun 2012 15:41:00 +0530 The bioinformatics market had registered CAGR of 15 percent during the beginning of the year 2000. However the growth rate started declining from 2007 onwards. But the growth has now started to pick up in the last couple of years. In 2011-12 the sector recorded a growth of 9.6 percent clocking 265.7 in 2011-12. The sector had witnessed an increase in the domestic revenue during last year. This rise was attributed to factors such as increase in public funding towards research and development (R&D) from the Government of India, decline in costs of human genome sequencing, increase in R&D investments by companies, and increase in the number of orders for contract research activities. As against the earlier notion of developing tools for drug discovery activities using Information Technologies, the bioinformatics companies now have been focusing on services also. In all, the sector has about 15 pure bioinformatics firms, 50 Bio-IT companies and 15 companies operating with mixed business model offering both informatics and contract services. Most of the pure bioinformatics companies have spun out of the premier institutes such as IITs, IISc and others universities. These companies have developed about 20 products in the last 10 years. Subsequently, they came up with latest versions of their existing products. India currently has close to 10 percent of the global professional and skilled bioinformaticians. There is a lot of demand for skilled and semi-skilled work force in this space in India as the job market for bioinformatics in western market has dropped. Because of the changing market trends, the bioinformatics companies have been operating as integrated outsourcing partners by offering services and solutions. Few others offer a spectrum of products for computer-aided molecule discovery, bio- and chemo-informatics, and structural biology services. Looking at the opportunities, companies such as Strand Life Sciences and Ocimum Biosolutions have established operations outside India mainly in the USA. However, due to global financial crisis and rise in the outsourcing of drug development activities, these companies have been forced to rethink their strategies. The fragmented bioinformatics market will see a growth in the coming years because of government's spending on R&D in addition to increase in private fundings.  Top Bioinformatics Companies  Sl. No. Company Revenue in crore 2011-12 2010-11 1 Strand Life Sciences* 49.14 42 2 Ocimum Biosolutions 49 65 3 Molecular Connections* 48.9 - 4 Geschickten* 0.45 0.65 5 NovoInformatics 0.2 - ]]> <![CDATA[Bioagri inching towards saturation]]> https://biospectrumindia.com/news/95/2741/bioagri-inching-towards-saturation.html https://biospectrumindia.com/news/95/2741/bioagri-inching-towards-saturation.html Wed, 27 Jun 2012 15:34:00 +0530 BioAgri was the fastest growing biotech segment registering 23 percent growth in 2011-12. The other sectors have recorded less than 20 percent growth during the period The BioAgri sector has registered a record revenue of 3,000 crore as compared to previous year's revenue of 2,480 crore. However, compared to last two years, the growth rate in 2011-12 was slow as this sector is inching towards saturation stage. Currently, close to 95 percent of cotton growing farmers have already adopted to the Bt technology leaving less scope of higher growth in the coming years in Bt cotton. There has been an increase in the area under Bt cotton over the last nine years. In 2010 kharif season, the area under Bt cotton was 249 lakh, acres which increased to 276 lakh acres in 2011. Bt cotton is the only genetically modified crop approved for commercial cultivation in nine states by Genetic Engineering Appraisal Committee (GEAC). At present, 64 companies sell over 780 Bt cotton hybrid seeds in India. Of these, 60 percent are based in Maharashtra and Andra Pradesh. About 35 companies have been involved in production and sales of Bt cotton in India. Forty million packets of Bt cotton were sold during 2011-12 while the estimate for 2012-13 is 36 million packets. The reduction could be due to the fall in cotton prices and increase in the price of Bt cotton seeds. However, the Bt hybrid cotton seeds market will grow after the farmers adopt the new agronomic innovation with high density planting for higher yields. The agricultural companies have been facing the problem of uncertainties associated with issue of no objection certificates (NOC) by state governments for carrying out field trials of genetically modified (GM) crops. During the entire season, the companies were unable to able to get permissions from the state governments in time. As a result, field trials for these GM crops have come to a standstill. However, things might improve in the coming months because of which timely testing of new technologies can bring benefits to farmers. The companies which are seeing competition in the market saw an increase in the Bt cotton seed prices. In 2010-11, the prices for Bt cotton seeds varied from 750 per packet of 450 gram for bollgard I (BGI) to 900 for bollgard II (BGII). In Punjab, Haryana and Rajasthan, the prices of Bt cotton seeds containing BG I and BG II traits were 750 per packet and 920 per packet respectively. In other states, the prices of BGI and BG II cotton are 650 per packet and 750 per packet receptively. The state governments have increased the MRP to meet the challenges of seed producers' increased costs. The increase in the central and south zones was 180 for both BGI and BGII while in North Zone the increment was of 75 for BG I and 175 for BG II. Although Indian government has approved six Bt cotton events for commercialization in the last 10 years, the most popular among these are MON 531 (BGI) and MON 15985 (BG II) developed by Mahyco with licensed technologies from Monsanto. The other events that got the approval include Event I developed by J K Agri Genetics with technology sourced from IIT Kharagpur; Event GFM, developed by Nath Seeds, the technology of which was sourced from a Chinese company; Event BNLA-601 jointly developed by Central Institute of Cotton Research, Nagapur and University of Agricultural Sciences, Dharwad and finally Event MLS-9124 developed by Metahelix Life Sciences. There has been an increase in the number of farmers cultivating cotton in 2002-03 from five million to eight million in 2011-12. Notably, the number of cotton farmers who have adopted Bt cotton has increased from 50,000 in 2002-03 to seven million in 2011-12, representing about 88 percent of the cotton growing farmers. India has reaped the benefits of Bt cotton. Now it is time to move to newer technologies which will improve yields. Top 10 BioAgri Companies Sl.No. Company Region Revenue in Crore %Change over 2011-12 2010-11 2009-10 2010-11 2009-10 2008-09 1 Nuziveedu Seeds South 745.00 610.00 476.86 22.13 27.92 31.02 2 Rasi Seeds South 392.00 371.88 358.78 5.41 3.65 -4.79 3 Ankur Seeds West 325.00 250.00 109.50 30.00 128.31 36.28 4 Mahyco West 314.00 359.00 312.00 -12.53 15.06 47.78 5 Krishidhan Seeds West 173.80 276.13 133.23 -37.06 107.26 110.64 6 Nath Seeds West 90.00 27.49 22.10 227.39 24.39 - 7 JK Agri Genetics South 50.66 32.17 32.50 57.48 -1.02 25.00 8 Mavens Biotech North 45.55 56.12 47.51 -18.84 18.13 119.15 9 Excel Industries West 10.94 12.13 8.24 -9.81 47.21 4.30 10 Metahelix South 4.68 0.67 6.00 598.51 -88.83 -37.95 ]]> <![CDATA[Bioagri: Inching towards saturation]]> https://biospectrumindia.com/news/95/1162/bioagri-inching-towards-saturation.html https://biospectrumindia.com/news/95/1162/bioagri-inching-towards-saturation.html Tue, 26 Jun 2012 20:51:00 +0530 BioAgri was the fastest growing biotech segment registering 23 percent growth in 2011-12. The other sectors have recorded less than 20 percent growth during the period The BioAgri sector has registered a record revenue of 3,000 crore as compared to previous year's revenue of 2,480 crore. However, compared to last two years, the growth rate in 2011-12 was slow as this sector is inching towards saturation stage. Currently, close to 95 percent of cotton growing farmers have already adopted to the Bt technology leaving less scope of higher growth in the coming years in Bt cotton. There has been an increase in the area under Bt cotton over the last nine years. In 2010 kharif season, the area under Bt cotton was 249 lakh, acres which increased to 276 lakh acres in 2011. Bt cotton is the only genetically modified crop approved for commercial cultivation in nine states by Genetic Engineering Appraisal Committee (GEAC). At present, 64 companies sell over 780 Bt cotton hybrid seeds in India. Of these, 60 percent are based in Maharashtra and Andra Pradesh. About 35 companies have been involved in production and sales of Bt cotton in India. Forty million packets of Bt cotton were sold during 2011-12 while the estimate for 2012-13 is 36 million packets. The reduction could be due to the fall in cotton prices and increase in the price of Bt cotton seeds. However, the Bt hybrid cotton seeds market will grow after the farmers adopt the new agronomic innovation with high density planting for higher yields. The agricultural companies have been facing the problem of uncertainties associated with issue of no objection certificates (NOC) by state governments for carrying out field trials of genetically modified (GM) crops. During the entire season, the companies were unable to able to get permissions from the state governments in time. As a result, field trials for these GM crops have come to a standstill. However, things might improve in the coming months because of which timely testing of new technologies can bring benefits to farmers. The companies which are seeing competition in the market saw an increase in the Bt cotton seed prices. In 2010-11, the prices for Bt cotton seeds varied from 750 per packet of 450 gram for bollgard I (BGI) to 900 for bollgard II (BGII). In Punjab, Haryana and Rajasthan, the prices of Bt cotton seeds containing BG I and BG II traits were 750 per packet and 920 per packet respectively. In other states, the prices of BGI and BG II cotton are 650 per packet and 750 per packet receptively. The state governments have increased the MRP to meet the challenges of seed producers' increased costs. The increase in the central and south zones was 180 for both BGI and BGII while in North Zone the increment was of 75 for BG I and 175 for BG II. Although Indian government has approved six Bt cotton events for commercialization in the last 10 years, the most popular among these are MON 531 (BGI) and MON 15985 (BG II) developed by Mahyco with licensed technologies from Monsanto. The other events that got the approval include Event I developed by J K Agri Genetics with technology sourced from IIT Kharagpur; Event GFM, developed by Nath Seeds, the technology of which was sourced from a Chinese company; Event BNLA-601 jointly developed by Central Institute of Cotton Research, Nagapur and University of Agricultural Sciences, Dharwad and finally Event MLS-9124 developed by Metahelix Life Sciences. There has been an increase in the number of farmers cultivating cotton in 2002-03 from five million to eight million in 2011-12. Notably, the number of cotton farmers who have adopted Bt cotton has increased from 50,000 in 2002-03 to seven million in 2011-12, representing about 88 percent of the cotton growing farmers. India has reaped the benefits of Bt cotton. Now it is time to move to newer technologies which will improve yields. Top 10 BioAgri Companies Sl.No. Company Region Revenue in Crore %Change over 2011-12 2010-11 2009-10 2010-11 2009-10 2008-09 1 Nuziveedu Seeds South 745.00 610.00 476.86 22.13 27.92 31.02 2 Rasi Seeds South 392.00 371.88 358.78 5.41 3.65 -4.79 3 Ankur Seeds West 325.00 250.00 109.50 30.00 128.31 36.28 4 Mahyco West 314.00 359.00 312.00 -12.53 15.06 47.78 5 Krishidhan Seeds West 173.80 276.13 133.23 -37.06 107.26 110.64 6 Nath Seeds West 90.00 27.49 22.10 227.39 24.39 - 7 JK Agri Genetics South 50.66 32.17 32.50 57.48 -1.02 25.00 8 Mavens Biotech North 45.55 56.12 47.51 -18.84 18.13 119.15 9 Excel Industries West 10.94 12.13 8.24 -9.81 47.21 4.30 10 Metahelix South 4.68 0.67 6.00 598.51 -88.83 -37.95 ]]> <![CDATA[Profiles - Krishidhan Seeds]]> https://biospectrumindia.com/news/95/2914/profiles-krishidhan-seeds.html https://biospectrumindia.com/news/95/2914/profiles-krishidhan-seeds.html Tue, 26 Jun 2012 20:50:00 +0530 MD: Sushil Karwa On aggressive roll out Introduction of newly registered products, new technologies for higher yield and establishment of newer facilities were the key initiatives Jalna-based Krishidhan Seeds Private Limited (KSPL) is adding more steam to its engine in order to roll out its expansion plans in the coming months. In 2011-12, the company clocked revenues of 173.80 crore from Bt cotton sales alone. It sold over 19 lakh plus packets of Bt cotton seeds during Khariff-2011 season. Today, Bt cotton acreage under KSPL seeds is between 13.5 to 14 lakh acres with a reach of around 6.75 lakh farmers in India. The company got a fillip in its product portfolio due to inclusion of newly registered products which had much higher productivity. Says Anup Karwa, director, life sciences, Krishidhan Seeds Group India, â€œIn north zone we could provide reliable CLCV tolerant hybrids such as Pancham and Border which performed better and have now become one of the leading brands as recognized by independent trade channels. It brought a new vigor in our market partners and KSPL had significant demand for its products both from public and private organizations.â€? KSPL has made big stride in another biotech range of products for biological plant nutrition and plant care through one of its subsidiary, Subhash Fertilizer. The group has developed crop specific formulations for cereals, vegetables, cotton and floriculture as well. Each tailor made product is able to confer significant yield increase by helping crop to establish better post germination growth, have robust root development and overcome soil nutrient deficiency. This apart, KSPL has also launched an improved maize hybrid Indra 17 which was recognized for its highest yields in AICRIP trials conducted under the aegis of ICAR. The hybrid shows full tip filling, and falls within the category of medium late segment. The hybrid has validated resistance to most common diseases and pests and drought tolerance. â€œAll this investment is being made to make Indian products achieve the current level of quality seen in the global products,â€? comments Karwa. Key Achievements Performance highlights Key strategy initiatives Future plans Provided CLCV tolerant hybrids such as Pancham and Border. In central and south zone, a high yielding new cotton hybrid Parivartan has been introduced. Set-up a new facility in Ahmedabad. Sold 19 lakh plus packets of Bt Cotton seeds during Khariff 2011 season. Bt Cotton acreage under KSPL seeds is 14 lakh acres with a reach of around 6.75 lakh farmers in India. Introduction of 3G enabled tablets for marketing field force. Revisited strategies and phased out BG portfolio and continue to offer better technologies such as BG-II. Subsidiary, Subhash Fertilizer introduced range of products which will bring in business to the company. Ambitious program for use of molecular markers. SNP marker analysis for absolute purity. ]]> <![CDATA[Profiles - Haffkine Bio-pharmaceutical]]> https://biospectrumindia.com/news/95/2859/profiles-haffkine-bio-pharmaceutical.html https://biospectrumindia.com/news/95/2859/profiles-haffkine-bio-pharmaceutical.html Tue, 26 Jun 2012 20:49:00 +0530 MD: P R Sabde Commendable turnaround Its portfolio of oral polio vaccines contributed to 90 percent of its business and the company has achieved 100 percent growth Maharashtra state government-owned, Haffkine Bio-pharmaceutical has realized that high priority to quality compliance norms is the secret formula to success, especially when it comes to sensitive products such as human vaccines. â€œHaffkine might be a public sector company, but today we are independent and run like any corporate company competing with the same set of private players in the market,â€? quips a top official from the company. A commendable fact is that unlike other public sector companies, Haffkine is not funded by the state government. The efforts have definitely reaped its fruits as the company has seen an exponential growth for fiscal 2011-12 compared to the previous fiscal's turnover. Haffkine has clocked revenues of 175.7 crore from vaccines alone as against 86 crore in 2010-11, with 90 percent of business coming from its oral polio vaccines. Huge orders from the Government of India and the UNICEF attributed to this growth. Says P R Sabde, managing director, Haffkine Biopharmaceuticals, â€œWe are a company that has survived the test of time. Our polio vaccines have shown a growth of 100 percent over the past one year. In 2011-12, around 340 million doses of Haffkine's polio vaccines were supplied and in the coming year too it would be a similar target.â€? A high point in Haffkine's achievements is the fact that the company has streamlined all its efforts and emphasis in revamping and upgrading its manufacturing facilities in tune with international quality norms. Huge investments have been made towards this initiative. Sabde highlights, â€œThe amount invested for revamping the oral polio WHO commissioned facility is around 9 crore.â€? The next 12 months will see the company running a race against time. It is gearing up for ambitious and large scale orders both for the Government of India and UNICEF. The company has a tender of 90 million doses of vaccines to be supplied to the Government of India by October 2012 and during the same period, it has a tender from the UNICEF to supply 140 million doses of oral polio vaccines. Again, between September-October 2012, there is a tender of 450 million doses and between January to May 2013, it has a tender to supply 300 million doses to the Government of India. â€œIt is a challenge but I am confident that given our mission and expertise, we can meet these targets,â€? concludes Sabde. Key Achievements Performance highlights Key strategy initiatives Future plans Huge jump in revenues due to orders from UNICEF and Govt agencies. As of March 31, 2012, a total of 1,70, 35,900 vials of trivalent oral polio vaccine and bivalent oral polio vaccines were manufactured which amounted to a total of 171 crore. Polio vaccines constitutes 90 percent of business and has shown a growth of 100 percent over the past one year. In 2011-2012, around 340 million doses of Haffkine's polio vaccines were supplied. Upgradation for its DTP vaccines facility. Project cost is approximately, 70 crore. The Tablet and capsule facility will be commissioned in 6-12 months. Haffkine has tenders for supply of 230 million doses of OPV by October and 750 million doses till March 2013. ]]> <![CDATA[Profiles - Advanced Enzyme Technologies]]> https://biospectrumindia.com/news/95/1954/profiles-advanced-enzyme-technologies.html https://biospectrumindia.com/news/95/1954/profiles-advanced-enzyme-technologies.html Tue, 26 Jun 2012 20:48:00 +0530 MD: C L Rathi Going global Exports will account for 70 percent of the company's business. India's leading home-grown enzymes company, Advanced Enzymes Technologies (AETL) has clocked revenues of 180 crore during fiscal 2011-2012 as against previous year's revenue of 154 crore. Almost 60 percent of the company's business today comes from its sales to the pharma and nutritional sectors. One of the significant developments for the company during the year was setting up of its facility in Indore to ramp up its production capabilities. C L Rathi, managing director, AETL, says â€œThis plant will triple our capacity levels and fermentation capacity from will increase from 160 cubic meter to 400 cubic meter. The commendable part of this project is that, the entire process of setting up of this plant was done in-house by our own employees and we did not look at hiring external consultants.â€? Earlier, a major chunk of AETL's business used to come from the domestic markets now that has changed. AETL is now focused on business from the international markets. This is because awareness towards the enzyme technology is more rampant in the international markets,â€? adds Rathi. The company is now looking at earning 70-80 percent of its total revenues from the international markets while the remaining 20-30 percent would be from the domestic markets. For a considerable period of time, AETL concentrated its efforts on the US markets and it is now strengthening its presence in the European markets. â€œWe are looking mainly at Western Europe which is Germany, Netherlands, Belgium, France and UK. We will look at the option of setting up 100 percent owned subsidiaries in Europe.â€? The company has already signed papers recently for setting up of an European subsidiary. The company is looking at expanding into China too but Rathi believes that it would take some time as China is averse to importing enzymes. It is looking at setting up a subsidiaries in Malaysia and Africa as well. The company is also embarking on the strategy of expanding its R&D base. AETL is currently developing a state-of-the-art research center in Mumbai. It has built a portfolio of over 50 enzymes so far. This portfolio consists of a wide range of carbohydrases, proteases and lipases. Rathi is confident of registering 30-35 percent sales growth in the next few years and hopes to cross 1,000 crores in revenue by 2020. Key Achievements Performance highlights Key strategy initiatives Future plans Setting up of its facility in Indore. The plant will triple its capacity from 160 cubic meter to 400 cubic meter. Expanding its R&D base. AETL is currently developing a state-of-the-art research center in Mumbai. Sales of pharma and nutritional products account for 60 percent of its business. Maximum business came from exports with US market being the top contributor. Registers 16.9 percent growth. International business to contribute 70 percent of business. AETL concentrated its focus on the US markets but now it is also looking at tapping the European markets mainly West Europe. Target growth of 30-35 percent in the coming years is achievable. In the next 5-8 years, the company is looking at hitting the revenue figure of 1,000 crore. ]]> <![CDATA[Profiles - Tulip Diagnostics]]> https://biospectrumindia.com/news/95/2788/profiles-tulip-diagnostics.html https://biospectrumindia.com/news/95/2788/profiles-tulip-diagnostics.html Tue, 26 Jun 2012 20:47:00 +0530 MD: Dilip Tripathi Exports boost sales For the fiscal, the group saw a good inflow of revenues coming from export markets compared to its domestic business Goa-based Tulip Group constitutes of Tulip Diagnostics, Microxpress, Orchid Biomedical Systems, Qualpro Diagnostics, Zephyr Biomedicals, Coral Clinical Systems, BioShields, Tulip Marketing, Crest Biosystems, Lilac Medicare and these companies collectively look into the manufacture and marketing of in vitro diagnostic reagents and kits, in national and international markets. For fiscal 2011-12, the group clocked a turnover of 225 crore as against last year's turnover of 185.63 crore (2010-2011). Exports revenue stood at 175 crore while the remaining turnover clocked at 50 crore generated from local market. Out of the companies, Tulip Diagnostics is the flagship company of the Tulip group and looks into the manufacture and marketing of in vitro diagnostics reagents and kits, dehyrdrates and culture media. Tulip saw a 21 percent surge in its revenues compared to the previous year's figure of 1.73 percent. This has been driven through exports. One of the key initiatives of the company during the year was that it focused on widening and increasing its products and reach to as many pharmaceutical companies and hospitals as possible. Also, during the year, some of the new products that the company launched included antibiotic discs and ready prepared media plates. On the whole, the group currently has a sales team of around 325 professionals spread across the country with a customer base of over 15,000 customers and 300 distributors. Tulip markets and distributes its products across 55 countries in South Asia, South East Asia, Middle East, Europe, Africa, Russia and Latin America. The group products are also bought directly by various NGOs and international agencies such as the UNICEF and the WHO for their various health programs. Key Achievements Performance highlights Key strategy initiatives Future plans Products launched were antibiotic discs and ready-prepared media plates. Tulip clocked sales of 225 crore. Registers 21% growth. Within its diagnostic turnover of 225 crore, exports constituted a major share of the total turnover. Exports revenue clocked to 175 crore while the remaining turnover clocked at 50 crore. Focused on widening and increasing its products and reach out to as many pharmaceutical companies and hospitals. Venturing into the manufacturing of molecular diagnostics kits. ]]> <![CDATA[Profiles - GlaxoSmithKline]]> https://biospectrumindia.com/news/95/1869/profiles-glaxosmithkline.html https://biospectrumindia.com/news/95/1869/profiles-glaxosmithkline.html Tue, 26 Jun 2012 20:46:00 +0530 MD: Dr Hasit Joshipura Stabilizing vaccine biz To strengthen its vaccine brands, the company has doubled its vaccine field force in the last two years and achieved its growth GlaxoSmithKline's (GSK's) vaccine business saw a good growth in sales in India, clocking an estimated revenues of 257.66 crore in 2011-2012. Presently, the company in India has within its portfolio 15 vaccine products which include Boostrix, Cervarix, Engerix-B, Fluarix, Havrix, Hiberix, Infanrix, Mencevax ACWY, Priorix, Rotarix, Synflorix, Tritanrix-HB, Twinrix, Typherix and Varilrix. GSK India is one of the leading companies in India in the vaccines space. In order to strengthen its vaccine brands in the domestic market, the company has doubled its vaccine field force in the last two years which has helped the company to achieve its growth and improve access. A close look into the company's vaccines business will reveal that its vaccine business grew at a significantly high growth rate of 45 percent. The key drivers of growth were its brands Havrix, Varilrix and Rotarix. In terms of R&D and regulatory matters, some of GSK India's novel innovator products approved by the regulatory agency in India during the year, include a 10-valent pneumococcal vaccine (Synflorix) for immunization of infants and children against sepsis, meningitis, pneumonia, bacteraemia and acute otitis media; this vaccine according to GSK will help reduce the burden of pneumococcal disease in India thereby helping in achieving the United Nations Millennium Development Goals. The R&D efforts of GSK Vaccines is also being supported by the clinical operations team in India by undertaking clinical studies for the company's vaccine initiatives, key among these are TB vaccine (phase II A), Conjugated Meningococcal vaccine, Herpes Zoster vaccine study (phase III) and Epidemiology study to understand prevalence of Streptococcus pneumoniae serotypes in India. The company has also seen a positive trend of improvement in its supply performance which was consolidated during the year. A key achievement was the stabilization of the vaccine portfolio through maintaining a consistent supply position for all brands. This improvement has also helped support the larger business performance trend. Key Achievements Performance highlights Key strategy initiatives Future plans Launched its 10-valent pneumococcal vaccine (Synflorix) for immunization of infants and children. Stabilized the vaccine portfolio through maintaining a consistent supply position for all brands. Its vaccine business grew faster than the overall vaccine market in India. The key drivers of growth were brands Havrix, Varilrix and Rotarix. Registered 45 percent growth in vaccine business. GSK India has now chalked out a growth path which is based on three pillars, one of the pillars being vaccines. In order to strengthen its vaccine brands in the Indian market, the company has doubled its vaccine field force in the last two years which has helped it to achieve its growth and improve access. The R&D efforts of GSK Vaccines is also being supported by the clinical operations team in India by undertaking clinical studies for their vaccine initiatives. ]]> <![CDATA[Expert Opinion - Vishal Gandhi]]> https://biospectrumindia.com/news/95/1848/expert-opinion-vishal-gandhi.html https://biospectrumindia.com/news/95/1848/expert-opinion-vishal-gandhi.html Tue, 26 Jun 2012 20:45:00 +0530 INVESTMENTS M&A activity on the rise The last three years saw 15 biotech mergers and aquisitions. The pace of deals will intensify further. Within the life sciences industry, biotechnology has been identified as a key area of growth with the global biotechnology market predicted to surpass $320 billion by 2015. The global biotech industry is led by the US, followed by advanced European countries. Developing countries such as India and China are soon emerging as major biotechnology nations. Indian biotech market has, in fact, tripled over the past five years and is projected to grow at a CAGR of over 20 percent to achieve a market size of $8 billion by 2015. Historically, there has been a large gap between the funding available for this sector and the funding required by the players to achieve their full potential. Biotechnology sector by its nature is high-risk/high-reward and requires long-term risk funding, especially for the start-up companies. The most suitable financing model for these companies is via venture capital (VC) and private equity (PE) investments. In the past decade, most of the equity investments have been in the established segments of pharmaceutical manufacturers, contract research organizations (CROs) and hospitals. However, Yes Bank believes that going forward the PE investments will be more diversified and will increase in upcoming industry segments such as biosimilars, vaccines, medical devices and diagnostics. On the basis of investments over the past five years, the average value of investments have been highest for diagnostic centers, followed by the pharmaceutical segment, which received more than 50 percent of the total PE investments in the life science industry over the last five years. The average amount invested in biotech and medical device companies has been comparatively much lower as these segments are still in the nascent stage and investors are not very aware of their operations and growth potential. Further, the biotech industry is considered high-risk, especially those companies which are developing innovative niche products. The last three years has seen significant traction in the biotech arena with close to 15 mergers and acquisitions (M&A) deals. The early indicators suggest that the M&A activity is bound to head north with a lot of big pharma and biotech companies looking at emerging markets to consolidate their global footprint. Sanofi-Aventis' acquisition of Shantha Biotech is a quintessential example of the surge in biotech M&A. With this acquisition, Sanofi has been able to enter the growing low-cost affordable vaccine market. Another recent deal has been Metahelix, a research driven agri-biotech company which has been acquired by Rallis, a TATA enterprise. In 2011, PE exits in India by value and volume which have both declined significantly. This is mainly due to the negative economic environment which is resulting in weak response to IPOs and lower valuations of companies by the investors. The situation is likely to continue to 2012 till the market stabilizes again. However, the biotech sector has been able to garner tremendous support from the government. Department of Biotechnology is pretty aggressive on funding innovative ideas. - Vishal Gandhi, senior vice president, Life Science Knowledge Banking , Yes Bank ]]> <![CDATA[Profiles - Sanofi Pasteur]]> https://biospectrumindia.com/news/95/1607/profiles-sanofi-pasteur.html https://biospectrumindia.com/news/95/1607/profiles-sanofi-pasteur.html Tue, 26 Jun 2012 20:44:00 +0530 ED: Dr Joselito Sta Ana Unmatched experience Sanofi-Pasteur continued with its tryst to introduce innovative vacceines in India Sanofi Pasteur India, a part of the Sanofi Group clocked an estimated revenues of 258.73 crore for fiscal 2011-12. Globally, Sanofi Pasteur, the vaccines division of Sanofi, provides more than one billion doses of vaccine each year. In India, Sanofi Pasteur has been a leader in pediatric vaccines with brands such as Pentaxim, Okavax, Typhim Vi, and Imovax and also offers several adult vaccines such as Vaxigrip, Pneumo 23 and Stamaril. The company's activities in India are focused on core product franchises namely influenza (seasonal and pandemic influenza), travel and endemic range (rabies, typhoid and yellow fever) and PPMHP (Polio, Pertussis, Meningitis, Haemophillus Influenza and Pneumonia). Today, the company plays an active role in the immunization programs of India. In terms of main highlights during the year, Sanofi Pasteur announced that it has entered into a marketing and distribution agreement with Emcure Pharmaceuticals in India for its anti-rabies vaccine, Verorab. The product will be imported and supplied by Sanofi Pasteur India and marketed and distributed by Emcure via its subsidiary, Zuventus Healthcare. Under this agreement, Sanofi Pasteur and Emcure will work together to raise awareness regarding rabies vaccination at the general practitioner and physician level. Zuventus Healthcare will now promote Verorab pan-India to over 60,000 physicians and general practitioners. It also got the government's nod for import of tetravalent dengue vaccines. Dr Joselito Sta Ana, executive director, Sanofi Pasteur India, said â€œSanofi Pasteur remains committed to its fight against rabies. In India, more than 15 million people are bitten by animals, mostly dogs every year and are at risk of developing rabies if no appropriate post exposure prophylaxis is quickly administered. We are excited about this agreement with Emcure, which will reinforce the presence of Verorab all over India.â€? Since its launch in 1987, more than 25 million doses of Verorab, a purified Vero cell rabies vaccine, have been distributed in the country. Key Achievements Performance highlights Key strategy initiatives Future plans Sanofi Pasteur has entered into a marketing and distribution agreement with Emcure for its anti-rabies vaccine, Verorab. In India, Sanofi Pasteur is the leader in pediatric vaccines and adult vaccines. Key role in immunizing 10 million people in India. It focused actively on influenza franchise (seasonal and Pandemic Influenza), travel & endemic range (rabies, typhoid and yellow fever) and PPMH (polio, pertussis, meningitis, haemophillus influenza and pneumo). To raise awareness regarding the rabies vaccination through Zuventus. To play an active role in the immunization programs of India, reaching population present in metros and non metro cities alike. Joining with the strong force of Shanta Biotechnics to look at ensuring reach of affordable vaccines to even the lower strata of society. ]]> <![CDATA[Expert Opinion - Shama Bhat]]> https://biospectrumindia.com/news/95/1095/expert-opinion-shama-bhat.html https://biospectrumindia.com/news/95/1095/expert-opinion-shama-bhat.html Tue, 26 Jun 2012 20:43:00 +0530 DIAGNOSTICS Molecular diagnostic is the future With DBT supporting this segment, molecular diagnostic is starting to pick up pace in India The size of diagnostic industry in India is estimated to be about 1,500 - 2,000 crore. This includes only the reagents and kits and not the instruments used in diagnostic industry. The industry consists of multinationals who supply the reagents on rental basis and supply the sophisticated and expensive instruments, which are closed end and need to be used with their own reagents; manufacturing companies who manufacture majority of the rapid test kits, ELISA, haematology, immunology and clinical biochemistry kits, and the other companies who package and sell. The growth in the diagnostic industry is estimated to be about 15 percent per year. Molecular diagnostic is expected to be the future and estimated to record 20-25 percent growth per annum. Investments are coming in a steady phase and more and more MNCs are willing to set up their production units in India. Low manufacturing cost and good quality people are the two major attractions for the industry. R&D spending by major players is about 10-15 percent of the total revenues and the added attraction of tax savings helps in setting up more and more R&D units. Added to this, the DBT funding also helps in taking some risks. For example we have two projects, one from SBIRI and another from BIRAP. These are having some risks, but since these are funded by the DBT, we can afford to take some risks with respect to the investments and project. Bhat Biotech India was the first company to bring Chikungunya kits to the Indian market and still is the market leader. Now, we are looking at bringing newer kits for TB, and many molecular diagnostic kits. We see that there is a huge potential for the molecular diagnostic kits in India and other countries. - Dr Shama Bhat, CMD, Bhat Biotech India ]]> <![CDATA[Profiles - Indian Immunologicals]]> https://biospectrumindia.com/news/95/1539/profiles-indian-immunologicals.html https://biospectrumindia.com/news/95/1539/profiles-indian-immunologicals.html Tue, 26 Jun 2012 20:42:00 +0530 MD: KV Balasubramaniam Expansion mode Having firmly established in the animal vaccine space, Indian Immunologicals is strengthening its position in the human health The last fiscal year saw Indian Immunolgicals (IIL) achieve revenues of over 282.23 crore from animal and human vaccines and therapeutics. IIL achieved a major milestone when Raksha-Ovac, its flagship brand crossed the 100 crore sales mark. It's the first brand from India in the animal health care sector to achieve this feat. Currently, IIL has the capacity to produce 250 million doses of Raksha Ovac, a Foot and Mouth disease (FMD) vaccine for cattle, making it the third largest facility in the world for FMD vaccines. Abhayrab, IIL's indigenously developed brand of rabies vaccine, hit the 90 crore mark this year, leading to the overall growth of the company. IIL was the second company in the world to launch a purified Vero cell rabies vaccine. The Brucellosis vaccine for the disease that affects cattle, buffalo, pigs, and other animals brought in revenues worth 60 crore. IIL is planning to make a further investment of 500 crore over the next few years into the plant at Karkapatla, Andhra Pradesh for further production activities. IIL is now accelerating its activities in the human vaccine realm to gain further market share. A number of innovative vaccine initiatives have been started, which include the indigenously developed Salmonella vectored cervical cancer vaccine against Human Papilloma virus. The vaccine which will be delivered orally, will soon enter clinical trials. IIL has collaborated with an organization from USA on a live attenuated virus vaccine for Chikungunya. Similarly, IIL is also developing a cell culture-based Japanese Encephalitis vaccine which is considered safer than the current culture system used. IIL also hopes to launch it's brand of indigenously developed pentavalent vaccine into the market soon. Other neglected diseases that IIL is working on include certain infections caused in humans by parasites such as hook worm and porcine cysticercosis (Taenia solium), work for which is in early stages of development. IIL continues to follow an integrated model for animal welfare by providing animal vaccines along with other therapeutics, medicines, nutrition, veterinary health services and cattle feed. Hence, this year, IIL saw tremendous growth of over 100 percent in these allied services while earning over 30 crore. Both vaccines and therapeutics have jointly contributed towards this year's earnings where these therapeutics have shown a steady growth. Key Achievements Performance highlights Key strategy initiatives Future plans IIL will soon set up a facility for producing 500 million doses of FMD vaccine. Vaccines for Chikungunya and Japanese Encephalitis and an oral cervical vaccine to enter into clinical trials by the next year. Raksha-Ovac, the flagship brand of the company became the first animal health brand in India to cross 100 cores sales mark. Abhayrab, IIL' s indigenously developed brand of rabies vaccine, hit the 90 crore mark IIL is also planning to make a further investment of 500 crore over the next few years for increasing its capacities. Hopes to launch indigenously developed pentavalent vaccine this year. For FY 2012-13 the company plans to achieve sales of 460 crore. IIL hopes to capitalize on the introduction of new animal and human vaccines and exports over the next year. ]]> <![CDATA[Expert Opinion - Rajesh Jain]]> https://biospectrumindia.com/news/95/2882/expert-opinion-rajesh-jain.html https://biospectrumindia.com/news/95/2882/expert-opinion-rajesh-jain.html Tue, 26 Jun 2012 20:40:00 +0530 VACCINES New benchmarks Increased collaborations, skilled workers, and state-of-the-art manufacturing facilities continue to make India the leader in this segment Vaccines continue to be important contributors of healthcare revenue across the globe. Global vaccines market has approximately tripled since 2000 and reached $26 billion in 2010, making it one of the fastest growing sectors of the pharmaceutical industry with pediatric vaccines dominating the global vaccine market, pediatric proprietary vaccines and pediatric enhanced combinations being the growth engines. In addition, adolescent, adult, and travel vaccines are continuously assuming significance. Geographically, developing countries are emerging as the main hub for low-cost high-quality vaccines. The key drivers of vaccine industry are cost effectiveness in combating diseases, greater appetite for vaccines from governments in the forecast period, technological advances in genetics and immunology and the launch of newer vaccines for treatment of range of diseases. In 2010-11 the vaccines market in India was estimated at around $350 million registering a growth of more than 22 percent over the previous year. It is estimated to gallop to over $1 billion by 2017 and then race to over $1.7 billion by 2020. Manufacturing and R&D trends India has emerged as leading vaccine manufacturing hub, producing 60 percent of global vaccines and is largely becoming a premier location with skilled workers and state-of-the-art manufacturing facilities for producing affordable vaccines. There are increased collaborations to bring newer vaccines and combination vaccines to market. This is a significant change compared to few decades back when India was not considered a focus area by pharmaceutical companies. At the same time, we are grappling with number of challenges at macro level. New vaccines, new markets and new production methods have to be embraced to ensure minimized costs and sustained growth. New technologies such as gene-based vaccines, VLPs, novel adjuvants and delivery systems represent promising approaches to future of India's vaccine industry. Currently, at two percent penetration, the vaccines market is significantly under-penetrated, despite suffering from a high burden of deaths by vaccine preventable diseases. Universal Immunization Program (UIP) till 2007 covered only six vaccine preventable diseases. Regulatory issues and business models Introduction of newer vaccines such as Pneumococcal conjugate vaccine, Rota Virus vaccine and HPV are going to spur the growth of vaccine market in India. Key issue will be funding for phase III efficacy and safety trial. For example, the Rota virus safety trial will involve sample size in excess of 50,000. Who will fund? Who will take up the risk of failure? Will it get included in UIP? What will be the demand and forecast? Will there be long term agreements? Apart from this, affordability is a major concern in India which needs to be addressed on priority by government and private organizations together. With nearly 470 million people living on less than $1 (PPP) a day, developing medicine which is affordable to mass audience is biggest challenge in front of us. Government is setting up new schemes such as Small Business Innovation Research Initiative (SBIRI) and Biotechnology Industry Partnership Program ( BIPP) which have provided an additional impetus to innovation and encouraged new entrepreneurs in this business. However government's spend on public healthcare remains lowest among that of most of the nations on the planet. Government should invest in healthcare and make medicine free for all. It should also encourage private capital investment in the industry and provide policies and infrastructure to attract more investment. Government's corrective interventions are desperately needed in an industry. - Dr Rajesh Jain, joint managing director, Panacea Biotec ]]> <![CDATA[Profiles - Eli Lilly]]> https://biospectrumindia.com/news/95/2280/profiles-eli-lilly.html https://biospectrumindia.com/news/95/2280/profiles-eli-lilly.html Tue, 26 Jun 2012 20:39:00 +0530 MD:Melt van der Spuy Riding on Insulin With new leadership in place, Eli Lilly India is looking at renewed strategies for expansion of its business operations and increased market share Having started Indian operations way back in 1993, Eli Lilly and Company has a come a long way to capture a substantial chunk of country's insulin market. In the FY 2011-12, Eli Lilly India is estimated to have clocked a revenue of 290.16 crore recording over 42 percent growth. Having a well established marketing set up in Gurgaon, India, Lilly caters to the patients suffering from diabetes, cancer, sepsis, osteoporosis, cardiovascular disorders and growth hormone deficiency. Overall, anti-diabetic product range contributes roughly 60 percent of the Lilly India revenue. The company saw change in guard at its Indian operations in November, 2011. Melt van der Spuy, a citizen of South Africa with varied experience in multiple geographies, was named the new chairman and managing director. Then in a major move, the company called off its partnership with Jubilant Life Sciences in January, 2012. The 50:50 joint venture, Vanthys Pharmaceuticals, between Jubilant Life Sciences' wholly-owned subsidiary Jubilant Biosys and Lilly, was to develop molecules from the pre-clinical to phase II stage across oncology, diabetes and cardiovascular segments. Eli Lilly entered into a strategic collaboration with Lupin in July 2011. The partnership is aimed to promote and distribute Lilly's Huminsulin range of products, including Huminsulin R, Huminsulin NPH, Huminsulin 50/50, Huminsulin 30/70 and Humapen Ergo II. Lupin's India formulations business will promote and distribute the range of products in India and Nepal, virtually doubling the number of sales representatives behind the diabetes care product. This collaboration is expected to double the current customer base of the company. Continuing to play its role in corporate social responsibility, the company announced a $30 million commitment in 2011 for five years to address non-communicable diseases in developing nations including India. The Lilly NCD Partnership will initially focus on diabetes, a core competency business area for Eli Lilly. Partners in India include the Public Health Foundation of India, a public-private partnership whose mission is to strengthen training, research, and policy development in the area of public health; Project HOPE the world's largest social marketing organization; and Population Services International, a long term Eli Lilly partner. The objectives in India are to develop diabetes awareness, patient care and provide training, improve treatment access, and research programs. Key Achievements Performance highlights Key strategy initiatives Melt van der Spuy replaced Sandeep Gupta as new MD of Eli Lilly India in November, 2011. The company entered into a strategic collaboration with Lupin Limited in July 2011. The partnership is aimed to promote and distribute Lilly's Huminsulin range of products. In the FY 2011-12, Eli Lilly India is estimated to have clocked a revenue of 290.16 crore as compared to 204 crore in last financial year. Continuing to play its role in corporate social responsibility, the company announced a $30 million commitment in 2011 over five years to address non-spread diseases in developing nations including India. The company continues to be the part of global $135 million â€œLilly MDR-TB Partnershipâ€? to confront multid drug-resistant tuberculosis. ]]> <![CDATA[Expert Opinion - Prahalad Achutharao]]> https://biospectrumindia.com/news/95/1227/expert-opinion-prahalad-achutharao.html https://biospectrumindia.com/news/95/1227/expert-opinion-prahalad-achutharao.html Tue, 26 Jun 2012 20:38:00 +0530 BIOINFORMATICS Capitalizing â€œomicsâ€? With some standardization required, next generation sequencing will change the dynamics of biotech and medicine. â€œI think the biggest innovations of the 21st century will be at the intersection of biology and technology. A new era is beginning.â€? - Steve Jobs What Y2K and time-to-market was to IT, next generation sequencing (NGS) will be to biotechnology. With the innovation moving from big research centers, pharmaceutical and seed companies to small labs, NGS combined with high-end technologies such as high performance computing and cloud are expected to change the dynamics of biotechnology and clinical medicine. However given the nature of the NGS data, its sheer size and dimensionality lead to uncertainty in the data which only a smart eye (inter-disciplinary team) will be able to see. Digging out compatible alternatives A number of bioinformatics tools developed are open-source and free, therefore making available various tools to choose from. One tool solves one problem better than the other; but most of these tools are not general purpose tools. And, it is almost always difficult to select the best set of tools from a large pool which is not compatible; because, data format of one tool is different from that of the other. Working towards changing this paradigm, the companies are developing various solutions and services models that can solve many problems related to omics sciences and translational bioinformatics. Future outlook and market Some of the biggest innovations in medicine and agriculture are bound to happen at the intersection of science, technology and engineering. Small to large biotech and pharma majors will eventually invest in genomic technologies for coming up with multi-busters. From drug discovery to patient stratification and clinical trials, we will see genomics playing a pivotal role. More and more hospitals will use genomic technologies for disease management and population health management for inclusive healthcare. At present, since majority of the users of this cutting edge genomics technology are from academia and government research institutes, the revenues generated by companies depend on the funding patterns of these institutes. We expect this to change in FY 2012-2013 with healthy research budgets being allocated to life sciences research across the globe. The key to translate hypothesis into discovery leading to applications in medicine and agriculture is to have an expert interdisciplinary team working on automated analysis workflow frameworks with faster and efficient algorithms that are statistically significant, scalable, simple and yet affordable; and this is what we are doing at Geschickten, building smarter technologies for a healthier planet. - Prahalad Achutharao, co-founder and CEO of Geschickten Biosciences ]]> <![CDATA[Profiles - Novozymes South Asia]]> https://biospectrumindia.com/news/95/1576/profiles-novozymes-south-asia.html https://biospectrumindia.com/news/95/1576/profiles-novozymes-south-asia.html Tue, 26 Jun 2012 20:33:00 +0530 Regional President: G S Krishnan Developing solutions Maintaining its position as the enzymes leader in India, Novozymes South Asia is now strengthening its research capabilities by partnering with local entities The largest supplier of industrial enzymes to industries across the spectrum in India, Novozymes has a 47 percent share of the global enzyme market. Currently Novozymes provides enzyme solutions for the detergent, food, feed, textile, leather, oils and fats, beverage alcohol, and biofuel industries. Novozymes India has registered estimated revenues of 297.7 crore in 2011-12. It believes in constant innovation to leverage technology platform, and growing its portfolio of sustainable solutions to various businesses. A few years back, the emphasis on R&D efforts, resulted in the scaling up of the research center which now houses the center of excellence for the wine and juice sector. Today, the center is not only involved with fulfilling the requirements of local customers but also in the application development for the needs of global entities. This year Novozymes entered into an exploratory agreement with Sea6 Energy, a young startup involved in using novel methodologies for the conversion of seaweed into biofuels. Novozymes will be involved in identifying the kind of enzymes that are required for the conversion of available sugars in the biomass in the sea water, while Sea6 is developing the technology of cultivating the seaweed at offshore locations. The research alliance will use enzymes to convert seaweed-based carbohydrates to sugar, which can then be fermented to produce ethanol for fuel, fine chemicals, proteins for food, and fertilizers for plants. The collaboration with Praj Industries, which started a few years ago for development of second generation biofuels is also steadily moving ahead. The pilot production plant for the same is currently under evaluation. The team is now exploring the use of local biomass such as corn cobs and bagasse for the production of biofuels. Additionally, Novozymes also launched Cellic CTec3 in India. It is an enzyme for better conversion of biomass to ethanol. Novozymes is looking to maintain its growth in the next couple of years and increase awareness for environmentally friendly solutions in industrial processes. Key Achievements Performance highlights Key strategy initiatives Future plans The R&D team has grown to over 40 today. Novozymes entered into an exploratory agreement with Sea6 Energy for researching enzymes for the conversion of seaweed into biofuels. The collaboration with Praj for production of 2nd generation biofuels has progressed with the pilot production plant for the same currently under evaluation. Novozymes is the largest supplier of industrial enzymes and micro organisms to industries across the spectrum in India. Has seen a healthy 23% growth in enzymes business especially in the household care, food and beverages industries. Is looking to partner with local companies to provide sustainable solutions that are region specific. Initiated a program on research on Indian flat breads on these lines. Hopes to capitalize on the increased awareness for environmentally friendly solutions. Target organic sales growth of more than 10% p.a. Novozymes is planning to further strengthen its position in the country by enhancing its global portfolio and developing local solutions to gain further foothold in the Indian market. ]]> <![CDATA[Profiles - Bharat Serums and Vaccines]]> https://biospectrumindia.com/news/95/6120/profiles-bharat-serums-and-vaccines.html https://biospectrumindia.com/news/95/6120/profiles-bharat-serums-and-vaccines.html Tue, 26 Jun 2012 20:29:00 +0530 MD: Bharat Daftary Solidifying domestic biz BSV plans to add more steam in its quest for innovation with increased R&D spend Bharat Serums and Vaccines (BSV) promoted by the Daftary family (Dr Gautam and Bharat Daftary) believes that the formula to the company's success lies in its focus on domestic and international markets, and not going after the generic products but instead opting for niche products for therapeutic areas, which have little competition in the market. In the process, the company recorded an impressive growth rate and turnover for fiscal 2011-12. Clocking an estimated revenues of 298.32 crore for the fiscal and registering a growth of 32 percent, BSV today manufactures and markets biologicals, pharmaceutical and biotechnology products. It has a portfolio of over 25 brands which includes plasma derivatives, monoclonals, equine antitoxins and serums cardiovascular, antimicrobials, antifungals, anaesthetics, and fertility hormones. Today, around 75 percent of its business comes from the domestic markets while the remaining comes from the global markets. BSV maintains that, while its main focus has been the domestic markets, its international business is slated to grow exponentially and that this approach would result in a growth in excess of what BSV has seen in recent years. Says Bharat Daftary, chairman and managing director, BSV, â€œGiven the kind of niche products we have for the regulated markets of the world, one needs to have suitable competencies and infrastructure, hence our approach is to enter into partnership and licensing deals in the regulated markets of the world.â€? Company officials continue to maintain that in order to keep the wheels of innovation churning, it has and will always be a research-driven company. BSV today invests around 12-14 percent of its turnover on R&D. Located in the Thane District (near Mumbai) of Maharashtra, the R&D facility houses around 70-80 scientists (including the analytical team) who look into three aspects crucial to BSV's business: biotechnology, novel drug delivery systems and biologicals and simultaneously creating intellectual property rights. â€œWe are focusing on novel drug delivery system (NDDS) with emphasis on unmet medical needs,â€? adds Daftary. In October 2011, the company had also commissioned its new plant for biotech products (mainly API). BSV's strategy for the domestic market is strengthening of its existing product basket, and launching new products around that particular brand. In terms of its existing product basket, BSV is looking at strengthening its fertility products. BSV will launch its product for sepsis this year, around July-August and currently it has got its approval from the DCGI for the same. This apart, BSV has also added three new divisions to its structure which includes urology, neurology and hematology. Key Achievements Performance highlights Key strategy initiatives Future plans Its fertility range of products has been the key growth driver for the company. BSV has also added three new divisions - Urology, Neurology and Hematology. Registered a 32 percent growth. Around 75 percent of its business comes from the domestic markets while the remaining comes from the global markets. Strengthening its existing product basket, which would ideally mean focusing on a core product/brand and building in new products around that particular brand. BSV is looking at strengthening its fertility products. BSV will launch its product for sepsis this year, around July-August 2012. Will look at partnerships and alliances in regulated markets of the world. ]]> <![CDATA[Expert Opinion - P M Murali]]> https://biospectrumindia.com/news/95/2297/expert-opinion-p-m-murali.html https://biospectrumindia.com/news/95/2297/expert-opinion-p-m-murali.html Tue, 26 Jun 2012 20:28:00 +0530 INDUSTRY Infusers changing biotech landscape India today is the global hub for affordable healthcare and emerging economies view India as their saviors for low-cost needs. India, the country that gave the oldest and established medicine system Ayurveda to the world, is too often criticized for lack of innovative contribution to the modern life sciences and biotechnology and being snubbed as a country known for making â€œcopy catsâ€? (generics and biogenerics) and excelling only in services. The negative sentiment is also reinforced by recent announcements from multinational drug companies opting to invest in China over India for their R&D efforts. It is very natural for critics to forget the real contribution based on our socio-political and economic environment. In the post-independence era, Indian life sciences industry discovered an untapped avenue of delivering affordable healthcare to millions. This segment has grown leaps and bounds in the country today and spread to most verticals including the biotech industry. India is the world's leading player and contributor in the cost-effective healthcare space and is also an exporter of low cost therapies to not only emerging economies but also to the developed world and all this without compromising on quality. Many of these could be classified as process innovation or improvement that enabled multinational pharma companies to improve their bottom lines. Indian CRAMS sector helped their cross-border partners to take multiple shots at their targets at a fraction of cost. Since each shot at the target requires different methods and not just repetition of existing methods, it involves innovation. Indian companies that did not participate in the entire value chain of new inventions (from molecules to market) due to lack of an eco-system, have now commenced their journey from a different stage. We now have world-class testing facilities and aspiring research centres. A view through the innovation kaleidoscope could expose a spectacular landscape wherein the local companies contributed to their partners in improving process, lowering cost of goods, affordable pricing, shrinking timelines, effective data management, increasing compliance levels, and thought provoking consultancy. Innovation at Grass roots An innovative continuum needs to have strong roots which India has and to strengthen this, several avenues are now available besides more are emerging on the horizon. Currently, there are a series of initiatives. One of the early innovation inducer and the one that works at the educational institution level is ABLE's BEST program which encourages young minds at schools and colleges to think solutions for our country's problems and rewards these young minds with seed money to incubate their company. It also nurtures them with their panel of professional experts. Another such program working at promoting innovation is Stanford India biodesign and the objective is to identify, promote and nurture next generation technology innovators with potential to develop custom solutions to Indian conditions. The fellows selected under the scheme are mentored by domain experts, legal and venture capitalists from US and India, and they are expected to spend time at Stanford University and return to India to customize the solutions according to the country's needs. At the institutional level, there are diverse opportunities that scout and promote innovation. Most popular among them is Gates Foundation and its program on grand challenges. Due to tough competition globally, it is not easy for Indian institutions to adapt their conceptualization for success. ICICI Knowledge Park (IKP) has taken a key initiative in co-ordinating all potential participants, rendering them with required support, scout and identify best proposals within the country and then act as conduit to help them win the grant. This is expected to give a major thrust to country's innovation landscape in foreseeable future, given the fact that objective of this program is to address local needs with disruptive technologies. Similar program worth highlighting is the Framework Program (FP) of the European Union that fosters a collaborative environment and helps build clusters of diverse expertise from across the world. Many of these projects also support innovative and affordable solutions to country's major issues in this space. Few other programs that support such initiatives include Wellcome Trust, Global TB alliance, and Forum for neglected diseases (DNDi). Department of Biotechnology (DBT) too helps in promoting innovation through its novel funding mechanism under BIRAC â€“ Biotechnology Industry Research Assistance Council via two key routes: BIPP â€“ Biotechnology Industry Partnership Program (an advanced technology scheme) to encourage public-private partnership scheme and CRS â€“ Contract Research Services to facilitate academia and industry interaction that supports exploratory validation of technology or prototype and its commercialization. All these are primarily targeted at supporting business ideas that are relevant to this geography and those which are amenable to faster commercialization keeping affordability of country's local population. In terms of non-profit initiatives, Council of Scientific and Industrial Research (CSIR) initiated the world's first Open Source Drug Discovery (OSDD) model that attracts talent from around the world. India's Innovation landscape is changing. Keen observers will be able to recognize that the micro climate for fostering innovation is now in place. From now on whatever the time it takes for new products and processes to appear on the global scene is the time it will take for the world to sit up and take notice. The mute question as always, can India do more in this space? The answer, like in so many areas including infrastructure development, is yes. - Dr P M Murali, managing director and CEO, Evolva Biotech and president, Association of Biotechnology Led Enterprises (ABLE) ]]> <![CDATA[Profiles - Mahyco]]> https://biospectrumindia.com/news/95/1441/profiles-mahyco.html https://biospectrumindia.com/news/95/1441/profiles-mahyco.html Tue, 26 Jun 2012 20:27:00 +0530 MD: Raju Barwale Extending Bt technology Having lead the Bt cotton introduction, Mahyco is now working on introducing this technology to food crops Maharashtra Hybrid Seed Company (Mahyco) is involved in research and development, production, processing and marketing of 200 products in 35 crop species, including cereals, oilseeds, fiber crops and vegetables. Bt cotton clocked an estimated sales of 314 crore in 2011-12 as against 359 crore during the previous fiscal of 2010-11. The total number of Bt cotton packets sold during the year was around 35 lakh packets in India. Maximum business today comes from its Bt cotton sales, mainly BGII packets due to its acceptability among farmers. The company has now developed insect-tolerant Bt brinjal and is currently awaiting approval from the Government of India for marketing it in India. Mahyco has a state-of-the art R&D center at Dawalwadi near Jalna in Maharashtra, with on going hybrid breeding programs in over 30 crop species and support programs in plant pathology, entomology, cytogenetics, biochemistry, tissue culture, rapid cycling, biotech and transgenic plant research. Beside this, Mahyco has five more research center and 18 multilocational crop performance testing centers distributed across the country. Over 200 scientists are engaged in the research programs at Mahyco. The research focus at the Mahyco Research Centre has been in areas related to improving crop performance such as tolerance to biotic stresses including pests, diseases and viruses, and abiotic stresses such as drought and salinity and increasing nutrient uptake efficiency Having established itself in the Bt cotton technology in India, Mahyco is now working on bringing this technology to food crops and this includes Bt okra and Bt rice. However, progress can be reported only when the Government of India first gives Mahyco approval for its Bt brinjal commercialization. Presently Mahyco is working on insect tolerance (sucking and chewing pest), herbicide tolerance, salinity tolerance, drought resistant seeds, nitrogen use efficiency and resistance against disease crops. Apart from expanding its hybrid business, the center is gearing up to bring out the Roundup Ready (RR) cotton, and discovering new traits in crops. Key Achievements Performance highlights Key strategy initiatives Future plans The company has now developed insect-tolerant Bt brinjal and is currently awaiting approval from the Government of India for marketing it in India. The total number of Bt cotton packets sold during the year was around 35 lakh packets in India. Maximum business today comes from its Bt cotton sales, mainly BGII packets due to its acceptability among farmers. Widening its product portfolio and offerings and enhancing the technologies that these seeds can offer farmers. Mahyco is working on insect tolerance, herbicide tolerance, salinity tolerance, drought resistant seeds. It is gearing up for bringing out the Roundup Ready (RR) cotton. ]]> <![CDATA[Expert Opinion - Nidhi Saxena]]> https://biospectrumindia.com/news/95/2848/expert-opinion-nidhi-saxena.html https://biospectrumindia.com/news/95/2848/expert-opinion-nidhi-saxena.html Tue, 26 Jun 2012 20:25:00 +0530 BIOSERVICES Adopting new business models With BioServices accounting for about 19% of the $4 billion Indian, biotech industry, it continues to be an important and growing segment. While the overall biotech sector is growing at a CAGR of 23.8 percent in India and is about to cross the $4 billion mark ($3.4 billion revenues in FY 2010-11), the BioServices industry accounts for 18.82 percent of the industry and stands at roughly $640 million and growing at a rapid pace of 23 percent CAGR. What's more, 95 percent of the BioServices revenues contribute to export revenues. Hence, it is an important and fast growing segment for the country. India is well placed for BioServices given its technically skilled manpower including highly competent medical, clinical and engineering professionals, good base of over 100 GMP manufacturing facilities in the country that are approved by the US FDA, low cost manufacturing and research and a strong IT base to support the clinical data management and analytical work. Within BioServices, the key segments are pharma contract manufacturing, contract R&D and clinical research. Analysts foresee growth at around 25-30 percent every year in these segments. So ideally, India is slated to become the hub for pharmaceutical companies and the industry has the potential to cross the $10 billion mark in the next five years. That notwithstanding, we are still very far away from achieving our goals and there are several bottlenecks. For one, the regulatory framework in India is still unpredictable, arbitrary and time consuming. The approval process is highly fragmented with multiple agencies being involved in approvals. Further, these agencies have low scientific expertise and have very little ability to deal with innovative technologies including gene therapy and biologics. More importantly, there is no clear cut agenda on what type of research to support and the approval norms are a lot more complex than those in the developed countries. The segment still does not attract the same kind of investment as does the IT services which is a hot favorite with private equity and venture capital groups. Also, while schemes such as DBT's SBIRI support biotechnology, there is no organized funding for BioServices companies. From the perspective of the BioServices firms, they need to adopt newer and innovative business models; for example, these firms need to look at changing from being pure play services companies to becoming innovation led companies adopting creative, risk sharing engagement models such as licensing and co-development. Here again, funding support for such bets shall be the key. India needs to show a high degree of strategic value add-over and benefit above these locations in order to attract businesses from key markets such as the US, Europe and Japan. In summary, while the BioServices industry undoubtedly has immense potential, it still needs a huge government funding and entrepreneurial thrust to see it really get to the $10 billion mark. - Nidhi Saxena, president and CEO, Karmic Lifesciences ]]> <![CDATA[Profiles - Bharat Biotech]]> https://biospectrumindia.com/news/95/4452/profiles-bharat-biotech.html https://biospectrumindia.com/news/95/4452/profiles-bharat-biotech.html Tue, 26 Jun 2012 20:22:00 +0530 CMD: Dr Krishna Ella Capitalizing collaboration With the promise of providing the Rotavirus vaccine for $1, Bharat Biotech has raised the bar for indigenously developed low cost vaccines Registering a healthy growth of 23 percent over the last fiscal year, Bharat Biotech has proven that providing vaccines at affordable prices can in fact prove to be a successful business model. Not only did it reap dividends off existing products but also it started to make significant progress in the research and development of other vaccines for infectious diseases. In June last year, Bharat Biotech announced that it would be selling Rotovac, touted as India's first indigenous rotavirus vaccine, at just $1, as compared to the existing prices of $8 per dose being supplied by multinational companies to public markets. Since its inception, Bharat Biotech has always strived to accelerate its research and development efforts by forging strong partnerships. The rotavirus vaccine is an example of such a model where a number of agencies were involved in developing the product. Similarly, the development of a Japanese Encephalitis vaccine is in advanced stages of phase III clinical trials and is expected to be launched in the next few years. Other projects include the development of the chikungunya vaccine which has completed pre-clinical trials and a typhoid conjugate vaccine which is in early phases of clinical trials. In therapeutics, the phase III trials for THR-100, a replacement for thrombolytics such as streptokinase and urokinase, with 120 subjects have been recently completed. This data is currently being evaluated. Bharat Biotech also manufactures its own pentavalent vaccine, COMVAC5. The company has the capacity to produce 20 million doses of this vaccine every year. Towards the end of 2011, in a major setback, WHO suspended the supply of Bharat Biotech's premier hepatitis B vaccine, Revac B to UN agencies and simultaneously suspended the applications for pre-qualification approvals of other vaccines undergoing evaluation. This was following a site audit at the manufacturing facility in Hyderabad. The suspension was a precautionary measure and no recall of distributed products was called for. The oral polio virus (OPV) vaccines supply by Bharat Biotech was not affected by this suspension. Key Achievements Performance highlights Key strategy initiatives Future plans The phase III clinical trials for the rotavirus vaccine are done. Japanese Encephalitis vaccine is in advanced stages of phase III clinical trials and is expected to be launched in the next few years. The Ella foundation, a not-for-profit started by the co-founders of Bharat Biotech, won a $10000 grant money from the BMGF to develop a vaccine against polio after the phasing out of the oral polio virus (OPV) vaccine. Bharat Biotech now has a product presence in more than 50 countries. Bharat Biotech targets the 5.8 million emerging market populations and is focusing on region specific neglected diseases. Bharat Biotech hopes to commercialize rotavirus vaccine by 2014 and obtain WHO prequalification by 2015. Further develop other vaccines and get prequalified. ]]> <![CDATA[Expert Opinion - Jignesh Bhate]]> https://biospectrumindia.com/news/95/2213/expert-opinion-jignesh-bhate.html https://biospectrumindia.com/news/95/2213/expert-opinion-jignesh-bhate.html Tue, 26 Jun 2012 20:21:00 +0530 BIOINFORMATICS Market in consolidation phase India has emerged as a land of immense opportunities in the area of bioinformatics. Rapid advances in biotechnology have led to a data deluge which has the potential to radically alter drug discovery landscape and may help personalized medicine to go mainstream in near future. The challenge of tapping this wealth of data to generate new knowledge has given rise to new business opportunities. Arrival of cost-effective human genome sequencing techniques and increasing public and private sector investment in genomics, proteomics and related technologies have given a significant fillip to bioinformatics research and startups in India. Indian bioinformatics market is focused on biological database creation and management; data analysis and visualization tools; and services and IT infrastructure. Companies from IT and life science sector are gradually gaining traction in bioinformatics industry by developing innovative products and services. Biological databases are generating significant amount of revenue for the bioinformatics industry. These databases are accessed by the pharma companies at key steps of the drug discovery pipeline and thus reducing time and money involved in drug development cycle. Bioinformatics companies are providing large scale text mining services to populate relevant information in these databases. The IT angle Growing volume of data obtained from wet lab and in-silico experiments has given rise to the challenge of storing and managing the biological data. Indian IT companies are addressing these challenges by adapting their existing know-how and developing wide array of new technologies and infrastructure for data storage and management. Cloud computing can be utilized here. Exponential growth of data has made it a very time consuming and challenging task to find the right information at the right time. Custom tools are being developed to enable researchers to carry out faster retrieval of data from databases. Creating tools for analysis and visualization of complex biological data obtained from these databases is another area of growth. Still some issues to resolve Despite making great strides, bioinformatics industry is facing problems such as interoperability of data, data standards and competition from growing number of publicly available biological databases. Indian companies are joining global consortiums and forums, and participating in collaborative research to solve these issues. Molecular Connections is part of the Pistoia alliance, which has many bioinformatics and pharma companies as its members â€“ trying to evole these standards. There are challenges for small and midsized companies to obtain funding to grow further. In spite of all these problems, the Indian bioinformatics market growth story is intact, and is expected to be in double digits in the coming years. Market seems to be in a consolidation phase and one can expect to see some more consolidation in near future. - Jignesh Bhate, CEO, Molecular Connections ]]> <![CDATA[Profiles - Panacea Biotec]]> https://biospectrumindia.com/news/95/2232/profiles-panacea-biotec.html https://biospectrumindia.com/news/95/2232/profiles-panacea-biotec.html Tue, 26 Jun 2012 20:20:00 +0530 JMD: Dr Rajesh Jain Hard hit by WHO The delisting of pentavalent vaccines from the WHO's list has resulted in negative financial implications for Panacea Biotec After registering its highest ever growth in FY 2010-11, Pancaea Biotec saw a sharp decline in its biotech revenue in FY 2011-12. The estimated vaccines and biosimilars business of the company stood at 384 crore compared to the previous year's revenues of 928.41 crore. According to Dr Rajesh Jain, joint managing director, Panacea Biotec, â€œSo far, we have shown consistent growth but due to certain setbacks, we unfortunately could not grow in this financial year. There have been certain disruptions, but I am confident that we will bounce back in 2013. We have initiated corrective and preventive measures to ensure compliance with the WHO pre-qualification guidelines and are in touch with WHO in this respect. We are confident that with these corrective and preventive measures, we will be able to get re-listing of our pentavalent vaccine in the list of WHO prequalified vaccines.â€? The removal of pertussis-tetanus based combination vaccine Easyfive, Ecovac4 and EnivacHB from the WHO list of pre-qualified drugs is the reason for drop in its biotech revenues. The company withdrew its oral polio vaccines (OPV) from the WHO list of pre-qualified vaccines voluntarily, stating the facility where the vaccine is being manufactured needs further corrective actions. Notwithstanding the setbacks, Panacea Biotec has been aggressively ramping up its production capacity, as well as introducing new business lines. The company on March 28, 2012, inaugurated its new state-of-the-art oncology facility at Baddi, Himachal Pradesh to meet the growing demand for anti-cancer products in the country. This new manufacturing facility will entail an annual production capacity of around 1.2 million vials, and being set up in compliance with various international regulatory standards. In two years, Panacea plans to offer all vaccines from the pediatric vaccine to adult vaccines with rotavirus, human papillomavirus, dengue and Japanese encephalitis vaccines by 2020. Several vaccines at present are in the pre-clinical stages and the company is in talks with the Global Alliance for Vaccines and Immunization as well as with UNICEF in identifying the needs of governments. Key Achievements Performance highlights Key strategy initiatives Future plans The company on March 28, 2012, inaugurated its new state-of-the-art oncology facility at Baddi, Himachal Pradesh to meet the growing demand for anti-cancer products. The company in collaboration with Nigeria-based Emzor Pharma, in February, 2012, launched POLPROTEC (an enhanced potency, inactivated poliovirus vaccine) in Nigeria. The vaccines and biosimilars business of the company generated an estimated revenue close to 384 crore. Initiated corrective and preventive measures to ensure compliance with the WHO pre-qualification besides focusing on the oncology segment. Re-listing of pentavalent vaccine in the list of WHO prequalified vaccines. Focus on new NBEs and NCEs. Targeting adult vaccine market. ]]> <![CDATA[Expert Opinion - DK Joshi]]> https://biospectrumindia.com/news/95/7738/expert-opinion-dk-joshi.html https://biospectrumindia.com/news/95/7738/expert-opinion-dk-joshi.html Tue, 26 Jun 2012 20:19:00 +0530 DIAGNOSTICS Growth promise In vitro diagnostics will continue with double digit growth. But a favorable policy is needed. Indian in vitro diagnostic (IVD) industry is currently growing at 18-20 percent and considering the huge population, increase in lifestyle diseases, affordability, improvement in living standards and improving healthcare infrastructure, market will continue to grow at same pace for the next 10 years. Although there is huge opportunity in the diagnostic kits and reagents manufacturing segment, more than half of the kits are being imported. There is no concrete policy for IVD in the present Drugs Act. The core committee of regulatory and industry associations has made general guidelines for diagnostic industry which has not yet been notified as an Act. There is no policy to promote R&D with special incentives by the Government of India. India has the potential of becoming the global hub for R&D, clinical trials, and pathology services. Some corrective measures are required on the industry and government front to address various issues such as licensing, limited technical expertise and stiff competition from imported products. - Dr DK Joshi, managing director, Beacon Diagnostics ]]> <![CDATA[Profiles - Rasi Seeds]]> https://biospectrumindia.com/news/95/1862/profiles-rasi-seeds.html https://biospectrumindia.com/news/95/1862/profiles-rasi-seeds.html Tue, 26 Jun 2012 20:17:00 +0530 CMD: M Ramasami Thriving with technology Having a market share of over 15%, Rasi is now looking to explore virus resistant and abiotic stress tolerant varieties of cotton In the last fiscal year, Rasi Seeds kept its position as one of the leading Bt cotton seed producer, commanding a market share of more than 15 percent with revenues of 392 crore in FY 2011-12. Rasi consolidated its position as the second largest bioagri company and is now looking at aggressively developing newer varieties of cotton to enable further growth. Currently, Rasi markets 18 cotton hybrids of BG I and 27 hybrids of BG II. The top performing brands include RCH 134 and RCH 650 in the North and RCH2, RCH530 and RCH 578 in Central India. The Bt cotton earnings contribute to over 85 percent of the total revenues. However, apart from cotton, Rasi also continues to focus on other crops such as maize, rice and pearl millet, all of which saw new generation hybrid seeds being released last year. Rasi also markets its array of vegetable seeds under the HyVeg brand. Rasi is now moving into developing new virus resistant varieties in different crops including cotton. This includes virus resistant cotton using RNAi technology, and virus-resistant cassava in partnership with Tamil Nadu Agricultural University. The latter project, involving the development of Indian cassava mosaic virus-resistant cassava, is jointly funded by the DBT and Rasi under a SBIRI scheme. Madurai Kamaraj University has provided the virus resistant gene. Rasi has other collaborations with Madurai Kamaraj University for Yellow Vein Mosaic virus resistant okra and with Indian Agricultural Research Institute (IARI) for Bt brinjal. Other projects, currently in advanced stages of development include insect resistant rice varieties such as yellow stem borer resistant variety, being developed in collaboration with University of Ottawa, Canada, and marker assisted molecular breeding of crops. Work on developing drought and salt tolerant crops is underway in collaboration with international organizations. Last year, Rasi entered into a partnership with International Rice Research Institute (IRRI), Philippines for developing abiotic stress tolerance in rice. Rasi plans to increase its reach, beyond the four million farmers that the company is currently serving. Along with increasing their R&D expenditure to eight percent in the next few years, Rasi hopes to create an impact with newer hybrids in rice, corn and vegetable seeds. Future growth is estimated to primarily come from providing better genetic varieties of cotton and further acquisition of technologies from across the globe. Rasi's ambition is to grow at the rate of 20-30 percent in the course of the next few years, fueled by the introduction of new varieties into the market, that are currently under research. The company hopes to become a 1,000 crore company in the next five years. Key Achievements Performance highlights Key strategy initiatives Future plans Launched two Bt cotton hybrids in North India, RCH 650 and RCH 653 and two in Central India, RCH 656 and RCH 659. Involved in development of Indian cassava mosaic virus-resistant cassava under SBIRI scheme. Rasi Seeds sold 50 lakh packets of Bt cotton last year. Registers 5.41 percent growth. Has decided to focus on developing virus resistant cotton varieties. Rasi aims to grow at 20-30%. Hopes to be a 1,000 crore company in the next five years. ]]> <![CDATA[Expert Opinion - GS Krishnan]]> https://biospectrumindia.com/news/95/2781/expert-opinion-gs-krishnan.html https://biospectrumindia.com/news/95/2781/expert-opinion-gs-krishnan.html Tue, 26 Jun 2012 20:16:00 +0530 WHITE BIOTECH India gains momentum Enzymes business is ready for the next leap. Forecast to witness a CAGR of 15 percent till 2015. In the global business warfare, every country has created its own niche. While China is known for its manufacturing competency, the US for its technological leadership, India in the last two decades has been able to make its mark on the global map through its IT services revolution. Going forward, India is advantageously positioned in the biotech sector and has immense potential to become the new global leader in the next decade, if it takes the right steps. India is already ranked among the top 12 biotech destinations worldwide and third largest in the Asia-Pacific region. The industrial biotechnology market accounts for approximately four percent of the biotech industry, mainly comprising of industrial enzymes that clocked 625.94 crore in 2010-2011, growing at a rate of 10.98 percent for 2010-2011, as against 564 crore in 2009-2010. Although, enzymes have been used for more than 50 years in the detergent, textile, food and feed industries, Indian industrial enzyme market is at nascent stage with a marginal share in the global market. However, it is ready for the next leap as it is forecasted to grow at a CAGR of 15 percent till 2015. Growth drivers Increasing environmental concerns, climate-change issues, stricter industry regulations, and recognition of the need for more sustainable products are the factors driving the growth of the industrial biotech segment especially, food and beverage, detergents, textiles, and fuel ethanol. Industry's concerns While the majority of the companies in India have started to acknowledge the benefits of the biotech solutions, most of them are still reluctant to change from the traditional practices. Cost has been seen as a major barrier in the adoption of new technologies, which is not always the case, especially in the long run. The other bottlenecks are regulatory approvals. While there is a big effort from the regulatory authorities to make the regulatory frame work in line with international best practices, the approval process still remains cumbersome. This makes it difficult to implement innovations and commercially launch new products for the benefit of the industry. However, this perception seems to change to positive momentum for the segment as the industry realizes the effectiveness of the solutions in their businesses. With the environment issue gaining importance globally, sustainability will be the game changing proposition. In a marketplace where the consumers are increasingly becoming environment conscious, slowly but steadily, like in other developed markets, sustainability will increasingly become a business driver for most of the companies in India also. The adoption of sustainable technology is still low in India as compared to some other developed countries. Unlike Europe, where voluntary codes are self-adopted by the industry, it takes longer in India to make companies realize the long-term benefits of the technology. However, the government is taking positive steps to facilitate the adoption of the technology, keeping in mind the impending resource crunch that can hamper growth. Government policy The government has provided a major thrust to this sector and has come up with progressive regulations and policies to further enhance its impact. Going further, the biotech industry in India will be faced with complex regulatory challenges and decisions as the market further matures. Therefore, in order to enable a quantum leap for the industrial biotech industry, it is crucial that the government not only comes out with new regulation in line with the international standards but also makes the approval process faster and simpler. Some of the biotech solutions, such as 2G Ethanol, that will help reduce our dependency on fossil fuels, creates job opportunities and ensure inclusive growth, need proactive financial support and involvement from the government. The Indian industrial biotech industry has laid a good foundation and is on its way to become a global player. No doubt there are always challenges for persistent success in a developing country, however, we can reap the benefits of this opportunity, only through firm strategies, active industry-academia participation, and most importantly proactive policies of the government. - GS Krishnan, regional president, Novozymes South Asia ]]> <![CDATA[Profiles - Novo Nordisk]]> https://biospectrumindia.com/news/95/2740/profiles-novo-nordisk.html https://biospectrumindia.com/news/95/2740/profiles-novo-nordisk.html Tue, 26 Jun 2012 20:15:00 +0530 MD: Melvin Oscar D' Souza Promoting awareness Novo Nordisk continues to be a leader in the Indian insulin market Novo Nordisk registered biotech revenue of 647.28 crore in 2011-12. With brands such as Levemir, NovoRapid, Novomix 30 and Victoza, Novo Nordisk continues to command more than half the share in the entire Indian insulin market. Novo Nordisk also commands a strong presence in other segments such as hemostasis management for hemophilia with Novo Seven and growth hormone therapies with its brand Norditropin. Set up in India in 1990, Novo Nordisk has capitalized on its wide range of insulin and insulin delivery devices to gain the leading position in India. The rise in the number of diabetes cases in India over the last few years has resulted in Novo Nordisk making key efforts for increasing awareness in diabetes management. Novo Nordisk recently extended its Changing Diabetes in Children (CDiC) program to India. This program hopes to create more awareness about diabetes in children by engaging governments and other agencies. The program entails free provision of insulin, blood glucometers and strips for the children. It has also developed a training manual specific to the diagnosis, treatment of diabetes care for children in developing countries. In India, 12 key opinion leaders have been attached to run 12 CDiC clinics covering a total of 10 Indian states, which makes it the most extensive launch till date. The Gujarat government recently signed an MoU with Novo Nordisk Education Foundation, a non profit organization, to launch the Changing Diabetes Barometer Project. This project aims to undertake a massive diabetes control program, which would include creating mass awareness of diabetes, conducting diabetes screening programs and enabling practical training camps for medical professionals. Key Achievements Performance highlights Key strategy initiatives Future plans Novo Nordisk extended its Changing Diabetes in Children (CDiC) program to India. 12 CDiC clinics covering a total of 10 Indian states will be established. Novo Nordisk Education Foundation signed an MoU with the Gujarat government to launch the Changing Diabetes Barometer Project. Novo Nordisk has registered 40% growth in its revenues. Brands such as Levemir, NovoRapid, Novomix 30 and Victoza have a insulin market share of more than 60%. For market expansion, Novo Nordisk is tying up with different governments like Bihar and Gujarat for screening and awareness programs. It will continue to leverage its wide portfolio of insulins to maintain leadership. Novo Nordisk will maintain its existing production and marketing partnerships and look for partnering with local companies for research. ]]> <![CDATA[Expert Opinion - D A Prasanna]]> https://biospectrumindia.com/news/95/1280/expert-opinion-d-a-prasanna.html https://biospectrumindia.com/news/95/1280/expert-opinion-d-a-prasanna.html Tue, 26 Jun 2012 20:14:00 +0530 CLINICAL RESEARCH Light at the end of tunnel Despite a fine ecosystem, regulatory uncertainties have neutralized growth momentum. Indian clinical research was projected to grow to $1 billion market by 2010 in a widely discussed McKinsey report of 2002. From these inspirational heights, the market was estimated at $250 million, in another widely discussed E&Y report in 2009. Leading CROs estimate a growth rate, since 2009, at a modest 5 percent and size the market in 2012 at $300 million. Stakeholders in clinical research are left wondering â€œwhere did things derail and what is the way forward?â€? For healthy growth, fundamentals of global competitiveness should be sound and the sector should attract talent, capital and leadership. Disease burden, medical infrastructure, attractiveness as a pharma market, clinical research expertise, cost competitiveness, and regulatory environment provide sound fundamentals for the growth of the Indian clinical research sector. It might be pertinent to note that the sector has attracted leadership and capital and capacity has been built. The ecosystem, when audited to global standards for GCP, GLP and GMP, compliance came out with very good results. Has the return to society been good? It is difficult to answer this, but it is easy to conclude that there is an under performance to the capacity established and a gross under performance to the potential. Another indicator is the opinion of investors. There are not many liquidity events. Lotus investors' story is perhaps the best, followed by IL&FS Ventures' exit from Acunova. In most other investment cases, the funds are struggling to get a meaningful exit. On the downside of the story, early this year, Mr Dennis Gillings, chairman, Quintiles told Economic Times 'if there is an element of doubt, you are seen as guilty and need to prove your innocence. I want to divert my investment to China'. In our experience, sponsors from Japan, US and Germany have decided to withdraw from India citing uncertain regulatory time-line, trial injury compensation issue, patent dispute decisions and NGOs' opposition to clinical research. Clients, talent and capital have shied away from India. Headwind in the sector has neutralized the growth momentum. Regulatory uncertainty and negative public perception are the two biggest causes. For the environment to improve, India needs an effective regulator, mechanisms to build positive public perception and a government with political will to back the regulator for the right decisions. For the political will to return, we would probably have to wait till next election. However, we can do something about the regulatory scenario. Meanwhile, we have to continue our focus on quality, participant safety, talent retention and align costs to revenue, to be the best in the world. Fundamentals of clinical research competitiveness of India remain robust. Let us remain motivated for the next few years and advocate a strong regulatory infrastructure. - D A Prasanna, chairman, Ecron Acunova CRO (Views expressed by the author are not necessarily views of Ecron Acunova) ]]> <![CDATA[Profiles - Nuziveedu Seeds]]> https://biospectrumindia.com/news/95/5916/profiles-nuziveedu-seeds.html https://biospectrumindia.com/news/95/5916/profiles-nuziveedu-seeds.html Tue, 26 Jun 2012 20:11:00 +0530 CMD: M Prabhakar Rao Bt cotton leader Asserting its foremost position in Bt cotton, NSPL is now partnering with different governments for providing additional services to aid farmers Maintaining its leadership position in the Bt cotton market, Nuziveedu Seeds private limited (NSPL) has emerged as a formidable player in the agribiotech sector with revenues of 745 crore in FY 2011-12. The reach of NSPL is such that currently more than 40 percent of the total cotton production in the country can be traced to the cotton hybrids developed by them. Nuziveedu Seeds sales have grown by 22 percent during the last year. Two Bt cotton products, Sona and Surakhsha were launched last year, specific to different agro-climatic zones in the country. Additionally, NSPL also got GEAC approvals for 164 cotton hybrids. This number signifies almost 18 percent of the number of hybrids that got approval last year. Apart from high selling brands such as Bunny and Mallika, 2011 saw NSPL improve the sales of its new Bt cotton hybrids such as Uttam, Raghav and Shalimar. Besides cotton, NSPL also produces and markets seeds for field crops such as paddy, corn, sorghum, pearl millet, sunflower and vegetable crops. A strong partnership with 80,000 farmers for seed production has enabled it to become the largest seed producer in India with an annual output of 32,000 MT hybrid seeds. Today, NSPL's seeds are used by more than 5.5 million farmers of the country. Their marketing network is spread across 17 states involving approximately 2,500 distributors and over 59,000 dealers. New product evaluation trials involving approximately 70-80 products in 160-170 locations are conducted every year, to select the most suitable product for every specified agro-climate in the country. The research and development (R&D) unit of NSPL is situated at Kompally, Andhra Pradesh and it prides in possessing the highest number of germplasms in India. The R&D center has over 171 personnel working on different projects. The center is attached to over 670 acres with fully irrigated research farms covering all agro-climatic zones of the country. It is also recognized as an ICAR testing center for cotton, maize, pearl millet, sunflower and rice. NSPL has and still continues to collaborate with various national and international organizations such as ICAR, SAUs, ICRISAT, AVRDC and IRRI. One of the highlights of the last fiscal was the strategic public private partnership with the Government of Maharashtra. Under this partnership, for the Kharif season of 2012, NSPL would be involved in introducing new agronomic interventions in 10,000 acres in Maharashtra. NSPL will supply the cotton seed to the farmer along with pre- and post-season package of practices through farmer trainings. Additionally, NSPL group will provide the forward market linkage to the farmers in Maharashtra for selling their products. This will allow their sister concern to buy the kapas (cotton) from these farmers at the prevailing market rate on the day of sale. Farmers can store the lint after ginning in the warehouse provided. This initiative allows farmers to sell their goods as and when they get a reasonable price and further help them obtain a bank loan at a lower interest rate. A similar partnership was forged between NSPL and the Uttar Pradesh government under a PPP for various agricultural extension activities. Under this project NSPL worked in 25 districts with paddy and maize for various extension activities such as crop demonstration, farmers trainings and field visits with the help of an Agriculture Technology Management Agency (ATMA) project coordinator. The project was finished in the last kharif season successfully. Such innovative extension services are very essential for the Bt cotton market to grow now as, it would be necessary to adopt new agronomic innovation with high density planting for higher yields. NSPL has also implemented barcode technology for better tracking of the large inventory movement. This initiative was recently started with the cotton crop. Further establishing its reach around the country, NSPL inaugurated its first integrated plant of cotton in Aurangabad. Spread across 125,000 sqft, this plant has been started to provide infrastructure for production and processing. The plant has a batch process dilute sulphuric acid-recycling delinting plant for planting cotton seed. State-of-the-art equipment has been used to ensure effective processing. Following up with earlier acquisitions of other seeds companies such as Pravardhan Seeds and Yaaganti Seeds, NSPL has also acquired Prabhat Agri Biotech in 2011. In terms of distribution hitherto, NSPL has decided to go in the collaborative route by co-partnering with companies such as KRIBHCO, Coromandal, Tata Chemicals, Hariyaali Kisaan Bazar via exclusive marketing tie-ups. For the expansion of the company's marketing network, more of such partnerships are now being looked at. Key Achievements Performance highlights Key strategy initiatives Future plans Two Bt cotton products, Sona and Surakhsha were launched in 2011. NSPL got GEAC approvals for 164 cotton hybrids. Implemented barcode technology. Initiated PPP with Government of Maharashtra for providing the forward market linkage to the farmers in Maharashtra for selling their cotton. More than 40% of the total cotton production in the country can be traced to the cotton hybrids developed by NSPL. NSPL acquired Prabhat Agri Biotech in 2011. NSPL seeds are used by more than 5.5 million farmers. NSPL sales have grown by 14% during the last year. Expansion of marketing network though co-partners such as KRIBHCO, Tata Chemicals. Focus on releasing new hybrids for maize, paddy and vegetables. Look for the expansion of its marketing network through more partnerships. NSPL has set goals to achieve a market share of 32% from current 28% in cotton seed with the help of newly launched products coupled with the intensive extension work. ]]> <![CDATA[Expert Opinion - B V Ravi Kumar]]> https://biospectrumindia.com/news/95/1941/expert-opinion-b-v-ravi-kumar.html https://biospectrumindia.com/news/95/1941/expert-opinion-b-v-ravi-kumar.html Tue, 26 Jun 2012 20:10:00 +0530 DIAGNOSTICS Radical changes Diagnostics is a big industry now and India can lead the way in new-age diagnostics. Diagnostic industry has long played Cinderella to the pharmaceutical step sisters and has been highly disorganised, trader or distributor driven, and neglected by regulatory authorities and thus by investors. In the last four to five years, there have been three radical changes in this sector. Diagnostic services have grown to become a huge industry and received good valuation of their enterprises. Enterprises focused on diagnostic manufacture have asserted their leadership position thus sidelining the distributors and fly-by-night operators. Tulip, J Mitra, Span Diagnostics and Bhat Biotech are good examples of this. New start ups such as Achira Labs with novel diagnostic platform technologies and multi-disciplinary approach (integrating biology with engineering) have come up and more importantly got noticed by international community. Bigtec Labs and ReaMetrix are the other labs who are building new diagnostic equipment. International PE funds have taken notice of Indian inventions rather than market or manufacturing innovations - recently Fidelity has invested in XCyton's new molecular diagnostic platform SES. Current drivers are huge government procurements under various programs and patronage from international funds. This has fuelled the growth of a generic industry around diagnostic reagents of blood grouping agents, HIV, HCV, HBV and pregnancy. Indian manufacturers have brought down the prices of diagnostics in the country. In case of all biochemistry, microbiology and immunology tests, the healthcare delivery (and in case of private hospitals) account for 95 percent of the total cost of a diagnostic. Bringing down manufacturer's margin has not made any difference to the total spend of the nation on diagnostics. But still the pressure is on the manufacturers to reduce their costs. There is also this notion that diagnostics should cost only a small fraction of the total cost of patient management. This notion has never been openly subjected to a rational debate because such a debate is viewed as politically incorrect. But this debate is a necessary prerequisite for all healthcare reforms being planned. However, there are many unmet medical needs for which diagnostics are required. Biomarkers are required not only to diagnose early but also to determine the course of therapy and end points of medication for many critical infections, cancers and metabolic disorders or chronic lifestyle diseases. These indications open up a $5-10 billion market in India alone. Instead of despairing about the hurdles, we need to leverage the enablers in our ecosystem to take the lead. Let us form partnerships between industry and academia, manufacturers and marketers and clinicians and researchers. We have all the elements necessary to become global leaders in the new age diagnostics. Let us not falter or delay! - Dr B V Ravi Kumar, chairman and managing director, XCyton Diagnostics ]]> <![CDATA[Profiles - Biocon]]> https://biospectrumindia.com/news/95/1149/profiles-biocon.html https://biospectrumindia.com/news/95/1149/profiles-biocon.html Tue, 26 Jun 2012 20:09:00 +0530 CMD: Kiran Mazumdar Shaw Carving a niche From unveiling of Asia's largest integrated R&D center to the dissolution of a major deal with Pfizer, it has been an eventful year for Biocon In FY 2011-12, Biocon became the fastest growing insulin company in India with a growth rate of 53 percent in that segment. Biocon's insulin revenues from value added services stood at 16 crore during the year. With an overall fourth position in the insulin market, Biocon is now looking to garner a bigger piece of the pie by entering into the device segment with the launch of Insupen. The biggest development for Biocon during the year was the conclusion of its exclusive $350 million commercialization deal with Pfizer in March. This deal had enabled Pfizer to commercialize Biocon's insulin products such as recombinant human insulin, Glargine, and Lispro. When they amicably decided to part ways, Biocon had already received approximately $200 million partly via an upfront payment and partly paid as an escrow account. However, it had to forgo the additional $150 million that it set to receive for meeting regulatory milestones. The company has stated that it will continue to develop the program for global registrations as planned, utilizing the retained payments received from Pfizer. Moving forward, Biocon hopes to ink licensing and marketing deals especially in the rest-of-the-world markets for its insulin products. Biocon remains one of the few companies that continues to invest up to 10 percent of their revenues into research and development (R&D). Some of the projects in the R&D pipeline at Biocon are now entering advanced stages. The most prominent one being Itolizumab, a novel molecule used for the treatment of psoriasis. The 52 week phase III clinical study, which involved 223 patients, was recently concluded. Biocon hopes to enter into a licensing agreement by 2013 for Itolizumab. Similarly on the biosimilar front, the partnership with Mylan signed a few years ago is progressing smoothly. Herceptin, a breast cancer drug is now entering phase III clinical trials for emerging markets and phase I trial for the EU market. The global trials for biosimilar human insulin are to conclude shortly whereas the global phase I trials for Glargine are now close to completion. The biosimilar versions of Lispro and Aspart are also due to enter clinical trials. Additionally clinical trials for BVX-20, a biobetter monoclonal antibody will also be initiated. Taking forward the global development of the oral insulin project seems to be on the agenda too, with Biocon stating that the company is in advanced stages of discussion for a partnership. The phase III clinical trials had displayed a high placebo effect, because of which IN-105 did not meet its primary end point. Senior members have stated that a partnership at this stage is not going to be an exact out-licensing one, but rather more of a back-end licensing deal. An important milestone for Biocon early this year has been the inauguration of the Biocon Research Center at Biocon Park in Bangalore. This recent addition makes the Biocon Park one of the largest research facilities in Asia with over 3000 researchers working in one campus spread across 200,000 sq ft. Spreading its reach overseas as well, Biocon held a project commencement ceremony for its facility in Bio-XCell Park in Malaysia in late 2011. Biocon plans to invest approximately $161 million making it the largest investment in biotechnology healthcare sector in Malaysia. The facility is poised to focus on research and later in biopharmaceutical manufacturing. With a diversified biosimilar pipeline and plans to forge more partnerships in the coming months, Biocon is all set to strengthen its position as an emerging global biopharma company. Key Achievements Performance highlights Key strategy initiatives Future plans Launched Insupen, a reusable insulin delivery device. Inaugurated the $25 million Biocon Research Center at Biocon Park. Announced $161 million facility in Malaysia in late 2011. Became the fastest growing Insulin company in India. Emerging markets now account for over 50% of Biocon's business as compared to just 35% until a few years ago. Registers 13% growth. Biosimilars under development for the Biocon-Mylan alliance are worth $33 billion. Called off $350 million commercialization deal with Pfizer. Will now focus on forging regional partnerships for marketing of insulin products. Focus on biosimilar portfolio for incremental returns. Look for regional partners in rest of the world markets for insulin products. Sustain higher revenue growth across verticals with high performance, focus and prioritize R&D programs. ]]> <![CDATA[Expert Opinion - Apurva Shah]]> https://biospectrumindia.com/news/95/1536/expert-opinion-apurva-shah.html https://biospectrumindia.com/news/95/1536/expert-opinion-apurva-shah.html Tue, 26 Jun 2012 20:07:00 +0530 CLINICAL RESEARCH Buoyant, but not booming India's clinical research sector has seen a negative tide since 2008 After witnessing a single digit growth for a couple of years, the global growth of outsourced drug development and clinical research has been steadily rising and it is expected to average between 12-14 percent over the next few years. The increase in the valuations of the global contract research organizations (CROs) is the reflection of the optimism about its growth prospects again. This is perhaps due to the fact that the world needs continuous investments in research and development (R&D) and a larger portion of the R&D is being outsourced every year. There is a trend to conduct increasing amount of R&D in new geographies where the right quality of data can be generated by optimizing cost and speed so that the new medicines can be brought to the market faster. During 2005-2009, India's clinical research industry grew by 17.7 percent, which is well above the world's average of 2.6 percent. But since 2008, we have been having a negative growth due to the non-industry friendly environment in India. Countries such as China have been growing consistently and the more shocking numbers are from South Korea which, in spite of having a tiny population in comparison to India, is doing more clinical trials in absolute terms and are growing at a faster pace. India must learn from countries such as Korea, which has invested in infrastructure to ensure that clinical research happens in an organized manner and which has established a robust regulatory framework that allows good clinical practice (GCP) compliant trials across the country. The Indian government will need to take a number of steps to eliminate the issues and regulatory hurdles that slow down the growth of the Indian clinical trial market. CROs are both optimistic and slightly skeptical about whether the predicted 20-25 percent growth figure will be achieved. Indian pharmaceutical companies are currently developing drugs for diseases including cancer, malaria and tuberculosis. These are green shoots of promise in the future which need to be nurtured, so that we develop the required expertise in the country to develop new drugs. This isn't a quick learning experience and will take years but the end result will be that, we will have the capability of developing drugs in India in an economical way and have a treatment for our local illnesses which does not exist in the western world either. To conclude, the Indian clinical research market is buoyant and many of the world's major pharmaceutical companies are looking at India for outsourcing partners thanks to its large patient population, disease demographics and significantly lower operational costs. In order to achieve aggressive growth targets, CROs and pharmaceutical companies must work with the Indian government to streamline regulatory framework, address ethical issues and establish new mechanisms for private-public partnership (PPP), enabling India to offer scientifically driven, value-added research. This way, India can lead the way in drug discovery and research innovation, while also addressing domestic healthcare challenges. - Apurva Shah, founder and group managing director, Veeda Clinical Research; chairman ACRO India. ]]> <![CDATA[Profiles - Serum Institute]]> https://biospectrumindia.com/news/95/4233/profiles-serum-institute.html https://biospectrumindia.com/news/95/4233/profiles-serum-institute.html Tue, 26 Jun 2012 20:06:00 +0530 CMD: Dr Cyrus Poonawalla; ED: Adar Poonawalla Powered by quality, scalability With a strong foothold in the emerging markets, Serum is now looking at making its mark in the regulated markets India's largest vaccine manufacturer, Serum Institute of India (SII) saw a surge in demand for its vaccine products over the past one year, especially for pentavalent and measles. In fiscal 2011-12, the company clocked a turnover of 1708 crore as against 1041 crore in 2010-11. Says Dr Cyrus Poonawalla, chairman and managing director, SII, â€œThe biggest achievement for us has been the turnover. This year's turnover has created history for the company. This is because of the good demand for our pentavalent, meningitis and measles vaccines over the last one year.â€? Keeping up to the global demands, the company during the year has manufactured a billion plus doses from its stable. These vaccines are supplied to international health agencies such as the WHO, UNICEF, PAHO, GAVI. It supplies vaccines to more than 140 countries across the globe. Exports this year constituted 82 percent of its total revenue. â€œMajority of our vaccines go into exports because more than India, a majority of other countries such as Bangladesh and Pakistan are more active in immunization programs especially for our pentavalent vaccines,â€? adds Dr Poonawalla. In fact, company officials are jubilant with the response its pentavalent vaccines has elicited. â€œOur pentavalent vaccines are of equally good quality but at a fifth of the price of those of the MNCs. Apart from this our vaccine for Meningitis A Conjugate launched in Africa has gained a lot of recognition from international agencies such as Bill and Melinda Gates Foundation,â€? Dr Poonawalla points out. Its intra-nasal H1N1 vaccine, Nassovac, has sold three million doses so far since it was first launched in 2010. SII has come a long way since it first commenced operations in 1966. â€œWe started with anti-sera products the strain for which we were sourcing from outside, and then our next main step was to move to a full fledged vaccine business. We started off with Tetanus Antitoxin followed by Tetanus Toxoid. Then in 1974 we got into DTP vaccines (Diphtheria-Tetanus-Pertussis) which was India's first combination vaccine and then we got into measles in 1985. Around 1990s, we started exporting our products to UN agencies and since then our success story has continued,â€? recalls Dr Poonawalla. The company also made its foray into biopharmaceutcials with the launch of its EPO product, ErepoXen. â€œThe results that doctors are getting compared to other competitors are far better. A lot of people are approaching us for the bulk and we are in the process of registration in other countries also. In the pipeline we have variants of EPO but they are in early stages,â€? adds Dr S D Ravetkar, executive director, SII. In terms of globalization, while SII has made a strong foothold in the emerging markets of the world, it is now looking at making an entry into the regulated markets. One strategy for entering such markets is co-development and marketing alliances with multinational majors present in these markets. Last year, SII signed an agreement with Merck to develop and commercialize a pneumococcal conjugate vaccine (PCV) for use in the emerging and developing world countries of the world. Together, Merck and SII will form a product advisory committee to oversee the activities required to develop and seek approval for PCV and pursue World Health Organization (WHO) pre-qualification. â€œThis is one of our models to foray into the developed markets of the world, to co-work and co-develop and this can be applied even for developing countries. The PCV vaccines are in the early stages and will take some time before they are commercialized, though work has started in our labs,â€? adds Dr Ravetkar. SII is in a constant process of revamping, upgrading or increasing its facilities. â€œNow to catch up for the huge demand we are looking at both product and facility expansion and at regular intervals you will find some facility up gradation happening,â€? says Adar Poonawalla. In terms of R&D, SII is looking at expanding its facilities not just in terms of equipment but also in terms of the facility space and incorporating the latest platform technologies. In a significant development, the Bill and Melinda Gates Foundation has pooled in funds for clinical trials of SII's Rota Virus vaccines in March 2011. The vaccine has completed its phase II trials and has entered phase III trials. Key Achievements Performance highlights Key strategy initiatives Future plans H1N1 vaccine, Nassovac has sold 3 million doses. Its EPO product is successful in the Indian market and SII has now filed registration applications in other countries. Pentavalent vaccines has had a good performance in the market. 64 percent growth in revenue over 2010-11. Exports constituted 82 percent of revenues. Manufactured over a billion plus vaccines. Becomes the largest biotech company. Building strategies to enter developed countries of the world. Entered into an alliance with Merck for co-development and co-marketing of PCV vaccines. Rota Virus Vaccines entering phase III trials. Looking at a 60 percent increase in capacity of pentavalent vaccines. Will look at lowering the prices of its vaccines launched in the future. Its SEZ Biopharma park is almost complete and will be operational in 2 years. ]]> <![CDATA[Expert Opinion - Anil Panwar]]> https://biospectrumindia.com/news/95/1021/expert-opinion-anil-panwar.html https://biospectrumindia.com/news/95/1021/expert-opinion-anil-panwar.html Tue, 26 Jun 2012 20:05:00 +0530 CLINICAL RESEARCH India takes a backseat Despite having 120 CROs, the Indian clinical industry showed a downward trend last year. Indian FDA and Clinical Trials Registry of India (CTRI) reported dramatic increase in multicenter and multinational clinical trials in India. This is in accordance with the current trend of off-shore outsourcing of clinical trials from North America to Eastern Europe, China, and India. India offers a promising solution to clinical research due to its established pharmaceutical and biotech industries environment and the ecosystem of contract research, R&D alliances, clinical trials, R&D for neglected diseases, in-licensing of pre-clinical, as well as clinical drug molecules, strong IT workforce and data management, and its herbal heritage. Low cost of innovation and development, skilled manpower, and a large patient pool are the additional advantages to clinical companies. In 2011-12, however, the Indian clinical industry struggled slightly. India is in the state of transition. Regulatory approvals in India are taking around six to nine months, where as in US it takes around 30 days. Owing to policy paralysis, CROs such as SiroClinPharm are setting shops in other markets such as Indonesia, Malaysia, and the Philippines. Moreover in India, only those drugs that have already passed phase I safety trials in the country of their origin can be tested on Indians. This policy also interferes with the Indian clinical industry growth. This situation will change as soon as the government is taking these issues seriously by streamlining the processes and devising new regulations and provisions. Despite this, India still has 120 contract research organizations (CROs) focusing on clinical studies and 1,500 approved sites. Technical trends From the regulatory point of view, conducting clinical trials now requires lots of approvals. The situation is getting more complex. It is now more difficult for a clinical researcher to adhere to all regulations and guidelines. Same is the case with finding and enrolling the subjects in trials. Central Drug Standards Control Organization (CDSCO) has released a new draft guidlines on approval of clinical trials and new drugs on July 24, 2011. Prior to that, CDSCO had approved a guideline on clinical trials inspection. New technologies on which research is going on include protein chips, transgenic animals, stem cells, medical devices and bioinformatics among others; impact of which is a shift in R&D view from clinical definition of disease diagnosis to molecular definition of disease diagnosis and predisposition. Apart from scientific innovations, trends can be stated as the central lab requirements getting complex; sponsors demanding more predictability, accountability, transparency and integration from vendors; sponsors are working more closely with institutional review boards (IRBs); adoption of new software such as SAS, SPSS, STATA for data processing is increasing; studies are becoming more focused; personalized medication trials are increasing in case of oncology; biosimilar trials and observational studies showing increase; and more CROs are entering phase I trials. - Anil Panwar, CEO, Fortis Clinical Research ]]> <![CDATA[Serum tops the list]]> https://biospectrumindia.com/news/95/1459/serum-tops-the-list.html https://biospectrumindia.com/news/95/1459/serum-tops-the-list.html Tue, 26 Jun 2012 19:59:00 +0530 Our tenth annual list of bioscience companies by revenues Serum Institute of India becomes India's largest biotech company in this year's survey clocking 1708 crore in revenues and registering 64 percent growth BioSpectrum â€“ ABLE Top 20 Biotech Companies Sl.No. Company Segment Revenue in Crore 2011-12 2010-11 2009-10 2010-11 2009-10 1 Serum Institute of India Biopharma 1708.00 1041.00 850.00 64.07 22.47 2 Biocon Biopharma 1676.40 1483.00 1180.00 13.04 25.68 3 Nuziveedu Seeds BioAgri 745.00 610.00 476.86 22.13 27.92 4 Reliance Life Sciences* Biopharma 693.00 490.00 450.00 41.43 8.89 5 NovoNordisk* Biopharma 647.28 462.00 362.00 40.10 27.62 6 Rasi Seeds BioAgri 392.00 371.88 358.78 5.41 3.65 7 Panacea Biotec* Biopharma 384.00 928.41 703.10 -58.64 32.05 8 Bharat Biotech Biopharma 326.00 265.00 271.66 23.02 -2.45 9 Ankur Seeds BioAgri 325.00 250.00 109.50 30.00 128.31 10 Mahyco BioAgri 314.00 359.00 312.00 -12.53 15.06 11 Bharat Serums* Biopharma 298.32 226.00 175.00 32.00 29.14 12 Novozymes South Asia* BioIndustrial 297.66 242.00 224.00 23.00 8.04 13 Eli Lilly* Biopharma 290.16 204.00 186.72 42.24 9.25 14 Indian Immunologicals Biopharma 282.23 269.07 261.97 4.89 2.71 15 Sanofi Pasteur India* Biopharma 258.73 160.68 - 61.02 - 16 GlaxoSimthKline* Biopharma 257.66 177.51 123.34 45.15 43.92 17 Tulip Diagnostics 225.00 185.63 182.48 21.21 1.73 18 Advanced Enzymes BioIndustrial 180.00 154.00 121.00 16.88 27.27 19 Haffkine Bio-Pharmaceutical Biopharma 175.70 86.00 168.98 104.30 -49.11 20 Krishidhan Seeds BioAgri 173.80 276.13 133.23 -37.06 107.26 21 Sanofi India (Formerly Aventis Pharma)* Biopharma 167.00 90.00 68.34 85.56 31.69 22 Concord Biotech Biopharma 145.01 126.17 111.07 14.93 13.60 23 Pfizer (Wyeth India)* Biopharma 102.98 73.35 53.00 40.40 38.40 24 Biological E Biopharma 98.96 0 - 0 - 25 Novartis Vaccines* Biopharma 96.82 92.72 - 4.42 - 26 Nath Seeds BioAgri 90.00 27.49 22.10 227.39 24.39 27 Dr Reddy's Laboratories* Biopharma 88.00 66.00 41.00 33.33 60.98 28 Rossari Biotech* BioIndustrial 79.20 72.00 55.38 10.00 30.01 29 RFCL (Diagnova) Diagnostics 65.00 56.00 - 16.07 -- 30 Span Diagnostics Diagnostics 58.52 92.53 78.98 -36.76 17.16 31 Maps BioIndustrial 58.00 48.00 - 20.83 - 32 Cadila Healthcare Biopharma 56.5 52.31 - - - 33 JK Agri Genetics BioAgri 50.66 32.17 32.50 57.48 -1.02 34 Strand Life Sciences* BioInformatics 49.14 42.00 35.00 17.00 20.00 35 Ocimum Biosolutions BioInformatics 49.00 65.00 76.00 -24.62 -14.47 36 Molecular Connections* Bioinformatics 48.90 0.00 - - - 37 Bharat Immunologicals & Biologicals Corporation BioPharma 48.55 0.00 - - - 38 Hester Biosciences Biopharma 48.26 41.97 37.53 14.99 11.83 39 Beacon Diagnostics Diagnostics 46.20 34.60 - 33.53 - 40 Mavens Biotech BioAgri 45.55 56.12 47.51 -18.84 18.13 41 Indovax* Biopharma 40.00 38.74 36.94 3.25 4.87 42 Oncquest Laboratories Diagnostics 40.00 16.00 - 150.00 - 43 Biovet Biopharma 36.00 0.00 - - - 44 Shantha Biotechnics Biopharma 26.3 46.2 334.23 -78.68 -18.62 45 Transgene BioTek Biopharma 26.25 7.00 4.04 275.00 73.27 46 Saamya Biotech Biopharma 23.29 16.94 2.35 37.53 621.56 47 Titan Biotech BioIndustrial 22.52 18.69 16.10 20.49 16.12 48 Zytex* BioIndustrial 22.00 21.00 18.00 4.76 16.67 49 Accurex Biomedicals Diagnostics 15.67 14.42 - 8.67 - 50 Shreya Life Sciences Biopharma 15.00 15.00 18.00 0.00 -16.67 51 Bhat Biotech Diagnostics 14.00 12.11 12.04 15.61 0.58 52 Excel Industries BioAgri 10.94 12.13 8.24 -9.81 47.21 53 Reckon Diagnostics Diagnostics 9.50 7.00 - 35.71 - 54 Vivan Life Sciences Biopharma 7.34 4.15 - 76.87 - 55 Metahelix BioAgri 4.68 0.67 6.00 598.51 -88.83 56 Imgenex Biopharma 4.00 3.00 - 33.33 - 57 Navya Biologicals Biopharma 3.50 2.50 - 40.00 - 58 Xcyton Diagnostics 1.50 1.50 - 0.00 - 59 Geschickten BioInformatics 0.45 0.65 - -30.77 - 60 NovoInformatics* BioInformatics 0.20 0.00 - - - ]]> <![CDATA[Govt strengthens clinical trials regulations]]> https://biospectrumindia.com/news/95/5124/govt-strengthens-clinical-trials-regulations.html https://biospectrumindia.com/news/95/5124/govt-strengthens-clinical-trials-regulations.html Tue, 26 Jun 2012 19:55:00 +0530 In a bid to strengthen the regulation and monitoring of clinical trials in the country, the Indian Government has announced several measures to strengthen the regulation and monitoring of clinical trials in the country. 12 New Drug Advisory Committees (NDACs) and 6 Medical Device Advisory Committees (MDACs) have been constituted to evaluate clinical trials proposals. These committees consist of leading experts from Central and State Government medical institutions. Also a draft notification has been issued for incorporation of a new rule in the Drugs and Cosmetics Rules, 1945, which addresses issues such as medical treatment and financial compensation to the trial subjects in case of trial related injury or death and the procedure for payment of financial compensation. Also an enhancement of responsibilities of Ethics Committee (EC), sponsor and investigator has been called for ensuring that financial compensation as well as medical care is provided to the trial subjects who suffer trial related injury or deaths and such information is provided to DCGI. One of the significant measures has been the amendment of the format for obtaining informed consent of trial subjects to include the details of address, occupation, annual income of the subject so as to have information regarding socio-economic status of the trial subjects. Obtaining vital information such as this would go along way in making the clinical trial process more transparent and hence reduce the negative connotations associated with them in the recent past. India unveils two new PPP programs Government of India launched two new programs in Public Private Partnership (PPP) mode. The purpose behind the creation of the PPP programs is to fuel innovation in various technological areas including biotechnology. The Global Innovation and Technology Alliance (GITA) is a program jointly created by Department of Science and Technology (DST) and Confederation of Indian Industries (CII) which seeks to leverage innovations taking place around the world by enhancing technology competitiveness of Indian industry and institutions through joint development, technology transfer and joint ventures. Whereas Millennium Alliance program is jointly created by India and the US and the DST is partnering with United States Agency for International Development (USAID) and Federation of Indian Chambers of Commerce and Industry (FICCI) to promote cost-effective and rigorously tested solutions for critical development challenges that have the potential for sustained global impact. Cipla reduces price of its cancer drugs Cipla has reduced the prices of its selected cancer drugs for the treatment of lung, liver, kidney and brain cancer. Cipla's Soranib (Sorafenib) will now be offered to cancer patients at a price of 6,840 for a month's therapy instead of the current cost of 28,000. TB now a notifiable disease The government of India has declared TB as a mandatory notifiable disease with immediate effect. The move comes close on the heels of the news of suspected TDR-TB cases being detected at a Mumbai hospital a couple of months ago. The notification process hopes to facilitate early diagnosis, rational treatment, prevention of complications, drug resistance and reduce deaths due to TB. It will also help the healthcare providers to offer better linkages for quality diagnostic and treatment services to the TB patients. Most importantly, it hopes to facilitate the National TB Control Programme (NTCP) to realistically estimate TB disease burden, plan resources and control measures that commensurate with the actual burden of disease for larger interest of the public and nation as a whole. Setting up of state level cells by NPPA With a view to strengthen the enforcement and monitoring system with the help of State Drug control administration, National Pharmaceutical Pricing Authority (NPPA) has inter-alia proposed a scheme for the 12th Five Year Plan titled, â€œCreation of NPPA State Government Coordination Cells in the States.â€? The NPPA-State coordination cell in the States will act as a nodal agency to oversee the compliance of drugs provisions in their respective states and will work under the direction of the NPPA. It will also serve as a local point for the consumer to lodge their complaint regarding overcharging, non-availability of drugs and other grievances. ]]> <![CDATA[PUBLIC SECTOR VACCINE MANUFACTURING 2.0]]> https://biospectrumindia.com/news/95/2318/public-sector-vaccine-manufacturing-2-0.html https://biospectrumindia.com/news/95/2318/public-sector-vaccine-manufacturing-2-0.html Fri, 11 May 2012 18:29:00 +0530 The Cabinet Committee on Economic Affairs has given its approval to the proposal of the Ministry of Health and Family Welfare for establishment of an Integrated Vaccine Complex (IVC) at Chengalpattu in the Kanchipuram district of Tamil Nadu. Will this decision change the future of the public sector vaccine units? he union government on January 15, 2008, suspended manufacturing licences of three public sector vaccine manufacturing units - Central Research Institute (CRI), Kasauli; Bacillus Calmette-Guérin Vaccine Laboratory (BCGVL), Guindy; and Pasteur Institute of India (PII), Coonoor, on account of noncompliance of good manufacturing practices (GMP) norms. The various parliamentary standing committees on health slammed the health ministry for failing to take enough steps to restart the manufacture of vaccines in the three major public sector vaccine manufacturing units and hence raising the costs of the Universal Immunization Programme (UIP). The committee chaired by former health secretary Javed Chowdhary in its February 2010 report had urged an immediate restart of manufacturing by them in public interest. The government on February 26, 2010, in exercise of its powers under sub rules (3) of rule 85 of the drugs and cosmetics rules, 1945, ordered revocation of suspension of the licences of these sick vaccine institutes. The units have now been reopened for manufacturing by the health ministry. Revival path The Union Minister for Health and Family Welfare, Ghulam Nabi Azad, recently stated in the Parliament on the fresh funding infused into the sick units. He informed that the Union Government has given an approval to upgrade the vaccine manufacturing facilities at BCGVL and PII at an estimated cost of 64.72 crore and 149.16 crore, respectively. After a brief lull, around 134.55 lakh doses of Diptheria, Pertussis, and Tetanus (DPT) vaccine have been produced in CRI Kasauli since the revocation of suspension of license in February 2010. The Pasteur Institute of India in the Nilgiris is all set to release its first set of anti-rabies vaccines in the market in June 2012. Sources aware about the future plans told BioSpectrum that about 39.5 million doses of DPT vaccines will be released in a year starting from June 2012. The third unit BCGVL, Chennai, is still to commence its manufacturing activities. Hence, the BCG vaccine, which protects against tuberculosis, is being supplied by the Serum Institute of India (SII), Pune. All the three units have also been asked to ensure that the production line is made fully compliant with GMP standards within three years. Reasons for failure Most of the non-governmental organizations (NGOs) in health area believe that the failure of the public sector units should be attributed to the failure of the government policies that ignored the requirement of the public sector units over an extended period of time. According to them, vaccine policies are increasingly shaped by industry's supply push. Vibha Varshney, science editor, Down to Earth magazine, observes, â€œIt is interesting that the policy, which has been made in response to a Public Interest Litigation (PIL) asking for revival of public sector units, has so little to say about their revival. The policy accepts that India does not have the capacity to manufacture new vaccine to justify the involvement of the private sector. Why shouldn't there be efforts to increase the capacity of these PSUs?â€? Culprits behind sickness? Poor patronage and policy support to public sector Frequent changes in production profiles Unfashionable under liberalization and globalization Routine production pressures Obsolescence of R&D infrastructure and receding emphasis on R&D Excessive dependence abroad Rigidities in recruitment and promotions Poor linkages, institutional mechanisms Governmental neglect of GMP Interestingly, most of the industry experts also share a similar opinion. According to Krishna Ella, president, Vaccine Manufacturers Association of India that represents the top vaccine manufacturers such as Bharat Biotech, Biological E, Panacea Biotec, Serum Institute of India and Shantha Biotechnics, â€œThe suspension or closure of vaccine manufacturing by the public sector vaccine manufacturers was perhaps due to lack of developmental planning in upgrading the facilities and equipment, inadequate compliance to GMP, lacunae in management practices and non-availability of suitable directors to head the vaccine manufacture and control.â€? â€œBy reopening and rejuvenating the public sector vaccine manufacturing units, the government may realize the vital importance of encouraging and sustaining the vaccine manufacturers to provide good quality vaccines that would meet international standards,â€? adds Ella. Current scenario The Cabinet Committee on Economic Affairs recently gave its approval to the proposal of the Ministry of Health and Family Welfare for establishment of an Integrated Vaccine Complex (IVC) at Chengalpattu in the Kanchipuram district of Tamil Nadu. The complex will be established by HLL Life Care, a public sector undertaking of the Ministry at an estimated cost of 594 crore. The project is likely to be completed by 2014. The news comes close on the heels of the government's recent directive for the upgradation of existing vaccine PSUs BCGVL, Guindy and PII Coonoor. The complex shall be the nodal center for research, manufacture and supply of vaccines under the UIP and are to be made available at affordable prices. The vaccines to be manufactured in the IVC include the pentavalent combination (DPT plus Hep B plus Hib). This move could be vital to fulfill the requirements following the government's plans for the inclusion of pentavalent vaccines in the UIP in December last year. Started initially in Tamil Nadu and Kerala, the program has now been expanded to include six more states. The center will also be involved in the manufacturing of BCG, measles, Hepatitis B, Human Rabies, Hib and Japanese Encephalitis vaccines. Revived PSUs Central Research Institute (CRI), Kasauli Bacillus Calmette-GuÃ©rin (BCG) Vaccine Laboratory, Guindy Pasteur Institute of India (PII), Coonoor The annual capacity of IVC is expected to be around 585 million doses. The vaccines manufactured in the IVC complex are proposed to meet about 75 percent of the total requirement of vaccines covered under the UIP and shall be able to meet the requirements of the major disease preventable vaccines in the country to a large extent. â€œThe total project cost of IVC is 594 crore, of which 28 crore has already been released. We have also started on-site preliminary works at the 100 acre area. Project office has started functioning with sufficient staff including the project officer,'' says HLL Chairman and Managing Director M Ayyappan. The project has been started to provide vaccine security and consequently the health security of the nation. Vaccines produced in the complex shall be utilized for immunization of pregnant women, infants and small children against various diseases throughout the country. After Suspension A peep into unfolding of events from the date the PSUs were suspended to now Jan 2008: DCGI ordered suspension of vaccine production in CRI, PII and BCGVL on non-compliance of GMP July 2008: Appointment of expert committee on the future of vaccine PSUs Feb 2009: Supreme Court issues notice to the Union Government in the vaccine PIL June 2009: Health ministry prepares an action plan to revive PSUs by 30 June 2010 Aug 2009: Government invests additional 14 crore to make CRI GMP-compliant Sept 2009: Government constitutes Javed Chowdhury Committee on vaccine PSUs Feb 2010: Health ministry sends revival orders to three PSUs April 2010: High Court issues interim order to the government to formulate a national vaccine policy Aug 2010: 43rd report of the Parliamentary Standing Committee on Health raps government Sept 2010: Final Report of Javed Chowdhury committee severely indicts government on PSUs Sept 2011: 52nd report of the Parliamentary Standing Committee on Health still critical April 2011: MOHFW released government's National Vaccine Policy, announced in July Nov 2011: High Court interim order to relook into government's vaccine policy document March 2012: Government says it has already approved img 213.88 crore package for upgradation of existing set up of BCG VL, Guindy and PII Coonoor. Welcome move The strong argument given in support of PSUs is that their existence is strategical as they are supposed to act as a buffer in times of medical emergencies. The supplies from government units can be faster than private players, claim those in support of their revival. The industry welcomed the government move and has come forward to help the government, though they were not consulted on these matters. Several industry leaders believe that there is still a lot of mistrust about private players. Did the shortage of vaccines supply from the private sector prompt the government to revive the vaccine units? The industry experts refuse to believe so. KV Balasubramaniam, managing director, Indian Immunologicals (IIL), Hyderabad, denies by saying, â€œShortage of vaccines is a thing of the past. That happened some years ago when the department units were suddenly closed due to GMP issues. They were not given time to modernize and improve. Our entry bridged a substantial part of that gap. This is a fact that has not been adequately acknowledged. We now meet a bulk of the requirements of DPT, TT and Hep B vaccines to the UIP programme. We had to discontinue measles vaccine due to issues with the way the vaccine was getting mixed up with diluents causing serious adverse events. The situation would have been worse if IIL did not step in.â€? Agreeing with him, Ella points out, â€œThe apparent shortage of vaccines, if any, from the private manufacturers was due to the lack of advance planning by the government to procure vaccines from them. Indian vaccine manufacturers also supply vaccines to the private trade in other countries and also to the United Nations Children's Fund (UNICEF) and Global Alliance for Vaccines and Immunization (GAVI).â€? Many say that there is also a misconception on the price situation. The general belief in the industry is that the prices went up not because of shortage of the vaccines, but the demands of higher levels of quality compliance and the need to incorporate vaccine vial monitors (VVMs). VVMs are said to be the single biggest component of cost sourced from a monopoly WHO approved supplier outside India. The other argument is that manufacturers have to also account for inflation and a depreciating rupee. â€œThere is now sufficient capacity in the country for the UIP vaccines and you are not hearing about shortages. There are a sufficient number of manufacturers for almost all the UIP vaccines, except the measles vaccine where there is just one manufacturer. Not withstanding this, there is definitely a case for reopening the units with good GMP in place to provide vaccine supply security,â€? says Balasubramaniam. Apprehensive future! Integrated Vaccine Complex to come up in Tamil Nadu Integrated Vaccine Complex (IVC) to be established at Chengalpattu, Kanchipuram district, Tamil Nadu HLL Life Care to set up the facility at an estimated cost of 594 crore HLL Lifecare floats subsidiary arm The project is likely to be completed by 2014 The complex is planned to be the nodal center for research, manufacture and supply of UIP vaccines to be made available at affordable prices The vaccines to be manufactured in the IVC include the pentavalent combination (DPT plus Hep B plus Hib) The annual capacity of IVC is expected to be around 585 million doses and accounts for 75 percent of the total requirement of vaccines covered under the UIP In the first phase, IVC will have capacity to produce 100 million doses each of pentavalent, measles, Hib, and BCG vaccines. It will also have capacity for 140 million doses of Hep B, 20 million doses of human rabies, and 25 million doses of JE vaccines It will have a WHO-prequalified facility, the first-of-its-kind in the public sector, to manufacture futuristic meningococcal, rotaviral, dengue and pneumococcal vaccines in its multibacterial and multiviral facilities to meet any epidemic or pandemic situations IVC also seeks to develop a strong R&D base, apart from manufacturing and supplying 75 percent of the vaccines required for the UIP The central government has also entrusted HLL with the task of revamping BCGVL, PII, Coonoor, and CRI. HLL aims to be 10,000-crore company by 2020 The future of these units still hangs in balance as they rely heavily on government support. Most believe that these units must be completely autonomous and free to take decisions on pricing and important issues pertaining to their growth. Balasubramaniam believes that the functioning of three units looked like that of production units of the Ministry of Health and not PSUs. He says, â€œWere they to be PSUs, the performance would have been much better. There is a case to reopen them in the interest of supply security but they have to be run as PSUs, given sufficient autonomy, managed well and earn enough to regularly invest in modernization and growth.â€? Rahul Koul in New Delhi ]]> <![CDATA['We focus on innovation and translational research']]> https://biospectrumindia.com/news/95/1399/we-focus-on-innovation-and-translational-research.html https://biospectrumindia.com/news/95/1399/we-focus-on-innovation-and-translational-research.html Fri, 11 May 2012 18:27:00 +0530 Sameer SavkurMD, Biogen Idec, India Biogen Idec, a global leader in the research and development (R&D) of multiple sclerosis (MS) therapies, started its operations in India in 2007. The Gurgaon-based company plans to further expand its clinical research in India in addition to bringing newer solutions for treatment of MS through multiple product launches in the next three-to-four years. Biogen Idec saw a change in leadership in August 2011, with Sameer Savkur taking over as new managing director from Dr Alpna Seth who moved to a bigger role at company's headquarters in the US. In a recent interview with BioSpectrum, Sameer Savkur discussed the current focus, R&D efforts, drug pipeline, and future strategies of the company. Which are the key focus areas of Biogen Idec in India? Savkur: Biogen Idec is committed to serving patients and the MS community. Seeing what scientific innovation can do for the patients has been very rewarding. Looking ahead to 2012, our aim is to take the proper steps designed to result in exceptional growth. This includes making all our products available for the Indian patients as well as continuing to advance our late-stage pipeline and prepare for multiple product launches that are anticipated by the end of 2015. Being the global leader in MS, we are constantly evaluating ways to support patients through our innovative programs such as Reach. What kind of R&D activities is the company pursuing? We are working to enhance our R&D capabilities, drive innovation, and grow our early-stage pipeline through building world-class scientific teams in our core therapeutic areas. We are increasing innovation and productivity of discovery efforts through greater focus; growing our early-stage pipeline through business development and internal discovery efforts; and increasing translational research efforts, including biomarker and imaging technologies. We have been able to utilize our translational research to develop tools that are helping physicians in taking better clinical decisions in the management of MS. What does Biogen Idec offer in India? Biogen Idec has two products available in India to treat multiple sclerosis. These are Avonex (Interferon beta 1a IM) and Tysabri (nataliz umab). What are the products in the drug pipeline? Our late-stage pipeline includes numerous therapies that could help treat patients with MS. Among these are Fampridine-sustained release, which is approved in the United States and Europe to help treat walking impairment in MS patients. Also, there is BG-12 which is an investigational oral compound in phase III clinical development for the treatment of relapsing forms of MS. There is PEGylated Interferon beta-1a, which is in phase III clinical trials and has the potential to reduce interferon dosing to as seldom as once per month. There's also the Daclizumab that has shown positive data in registrational trials and has an ongoing clinical trial program with a readout expected in 2014. We also have therapies in phase III clinical trials for the other neuro-degenerative diseases, such as Amyotrophic Lateral Sclerosis (ALS), and haematological disorders, such as hemophilia. These therapies include the Dexpramipexole for ALS and long-lasting rFactor VIII and rFactor IX for hemophilia. What is the company's strategy to achieve the targeted growth and goal? In 2011, Biogen Idec's global revenues increased 7 percent to 2,500 crore ($5 billion) year-on-year. In 2012, our aim is to take steps designed to result in exceptional growth. We will work to grow our existing product portfolio, continue to advance our late-stage pipeline, prepare for multiple product launches anticipated by the end of 2015, and grow our early-stage pipeline through internal research and strategic collaborations. Do you think the biotechnology industry in India has been able to meet the growth expectations? The biotech sector is one of the fastest growing knowledge-based sectors in the country. India's success in biotechnology will depend largely on how it implements policies for biopharmaceutical products (biologics) that balance innovation and access. In a developing country such as India, we should remain sensitive to the needs for greater public access to safe and effective medicines. Scientific breakthroughs to treat diseases are driven by biotechnology. Becoming a global leader in this arena will require that we continue to attract innovative pharmaceutical and biotech sector investments by ensuring conducive regulatory and intellectual property environment. Some of the important milestones in this direction will be to have effective patent laws and guidelines for biosimilars registration. Rahul Koul in New Delhi ]]> <![CDATA['India has unique scientific capabilities']]> https://biospectrumindia.com/news/95/2830/india-has-unique-scientific-capabilities.html https://biospectrumindia.com/news/95/2830/india-has-unique-scientific-capabilities.html Fri, 11 May 2012 18:24:00 +0530 GS Krishnanregional president, India, Novozymes South Asia Novozymes, a global leader in industrial enzymes, has grown from strength to strength in India after its acquisition of Biocon's enzyme business in 2007 and has a diverse team of over 400 people. Novozymes has become an institute for sustainable solutions. It is partnering with local players to find innovative enzyme solutions. Heading the operations is GS Krishnan, regional president, India, Novozymes South Asia, who has been with the company for more than 20 years. He speaks to BioSpectrum about how Novozymes is building the local expertise to service the global markets as well as the company's expansion plans. Novozymes has collaborated with companies such as Praj and most recently with Sea6 Energy. How have such partnerships helped you advance the biofuel segment? Krishnan: Sea6 Energy is an upcoming organization by young entrepreneurs who are looking for different methods to produce ethanol using seaweed. The collaboration is such that we are currently identifying the kind of enzymes that are required for this process. While they are developing the technology of cultivating the seaweed at offshore locations, we are researching the right enzymes for converting the available sugars. We have been in collaboration with Praj to develop second generation ethanol from biomass for almost two years now. The research and development (R&D) work has progressed well to a stage where currently the team is evaluating the pilot production plant while working on Indian substrates such as bagasse and corn cobs. Since we are working on similar projects around the world, this gives us an edge over other companies in the enzyme industry. The collaboration is such that we build on the knowledge and expertise we have acquired globally and play the role of an enzyme manufacturing company whereas they are the engineering experts who will ultimately commercialize the product. How important are the India operations to the global entity of Novozymes? India is unique in terms of its scientific capabilities. Like in the case of Sea6 which had a very innovative platform, Novozymes would like to take advantage of any local talent or skills not only to develop it for local markets, but also to develop it for the global markets. We are open to any collaborations. India is a very important market for us and the opportunities are very good in all segments. We are the only company, I think, that supplies every industrial application of enzymes. Our leadership role is not just in the market, but also in the fact that we have all the industries covered here in India. One important factor is that the population of Indian middle class is increasing to a point where some surveys predict that by 2025 our middle class population will equal the European population. Things such as increased buying power and changed spending habits will contribute to the overall growth of the economy. How do you view the Indian enzyme industry? We have maintained double-digit growth for the last five-to-six years. There is competition in the market. It is a level playing field for all the present competitors, but we are one of the few organizations that is playing a global role which differentiates us from the rest. Innovation is a continuous process at Novozymes, depending upon the demand in the marketplace. We will grow as and when the market demands and I definitely see the demand increasing. How do you plan to expand in India? We are increasing our presence in all ways. As far as the R&D is concerned, we were hardly five-to-six people two years ago whereas now there are more than 40 people who are part of the R&D center inaugurated in 2010. Today, the development of new enzymes and the local application development is done here. Also, there is a center of excellence which supports the development of enzymes for the fruit juice and wine sector. The center supports application development for the global requirements as well as specific requirements of local customers. The global CEO of Novozymes, Steen Riisgaard, recently commented on how the market's economic uncertainty is set to continue this year. Should Novozymes India worry? Two years ago when recession struck, Novozymes in India did not actually feel any major impact. The markets for the company were affected in certain places, though we did not have a big impact specific to our industry in India. We are not completely dependent on exports unlike other sectors, hence I am very positive about the future. What are the current challenges in the industry? Biotechnology and especially industrial biotech is still in a nascent stage in India but there are a lot of opportunities. There are various initiatives by the Government of India, such as the Food Adulteration Act, which are good to bring India at par with the rest of the world in terms of standards. Currently, the regulatory framework is such that they do not have an approval for some of our enzymes. In this light, the fact that regulators are moving to adopt global standards is a good step for supporting our business. Do you see an increased concern by the companies in India for the environment, which can boost industrial biotech industry? Industrial biotech relies heavily on things such as increased environmental concerns. Few companies are consciously looking at sustainable solutions and they are turning to biotechnology for these solutions. The government's initiative for reducing carbon emissions is far more serious today, which will definitely help us. Do you think the industry can reach the goals set by the biofuel policy of blending 20 percent ethanol by 2017? Currently, we do not have the alternative to satisfy even 5 percent of the ethanol requirements to be added to the fuel. If we have to fulfill the requirement of blending 20 percent ethanol by 2017, the only way is to obtain ethanol from biomass, such as sugarcane bagasse or straws from sugarcane, rice, or wheat. There are multitude of challenges beginning with the growth of the biomass to its supply, transport, and processing. We are supporting the technology to produce the biofuel but the broken network of the supply of biomass needs to be addressed. Manasi Vaidya in Bangalore ]]> <![CDATA['We expect over Rs 50 crore revenue in next 3 years']]> https://biospectrumindia.com/news/95/8472/we-expect-over-rs-50-crore-revenue-in-next-3-years.html https://biospectrumindia.com/news/95/8472/we-expect-over-rs-50-crore-revenue-in-next-3-years.html Fri, 11 May 2012 18:21:00 +0530 Kalpesh Jain, COO, Krishgen BioSystems Despite the looming global economic crisis, Krishgen BioSystems has seen a decent year-on-year (YoY) growth of 20 percent. Apart from being a distributor for 47 principals, the company has been proactive in commiting investments into its own setups. It has come up with a new pilot laboratory and manufacturing facilities. The company has set an ambitious target and aims to touch 50 crore in sales in the next three years. Kalpesh Jain, chief operating officer, Krishgen BioSystems, talks to BioSpectrum about the company's performance and his optimism towards the Indian agri-biotech sector. Q The last fiscal (2011-12) has been the year of consolidation for Krishgen BioSystems. Please share some achievements of the company. Jain: Krishgen has crossed 18 crore in revenue for the year 2011-12, which is a 20 percent YoY growth over that in 2010-11. It has been a year of consolidation for us as our new facility is now operational in Mumbai. This facility has capabilities for immunoassays, molecular biology, bioprocess, and cell culture. We expect to grow our revenues to over 50 crore in the next three years. We have successfully established a footprint outside India for export of our bioprocesses and plant sciences products. Our focus as a biosupplier to the industry has been on backward integration by developing our own tools as products and services as opposed to only distribution of products from the global principals. Q What is your target for fiscal 2012-13? Our targeted revenue for 2012-13 is 25 crore. Our aim is to register 40 percent YoY growth in the next two-three years. Q How has the company expanded its business in the Indian biotech sector? Our major thrust area is drug discovery research where we offer low-cost assays to maximize the research budgets of our users. With over 47 principal companies working with us, we offer end-to-end solutions, be it kits or consumables. With broad portfolio of products such as molecular biology reagents, cells, medias, reagents, and immunoassays, we today have a market presence in preclinical toxicology, immunoassays for diabetes, bone metabolism research, and primary human cell culture products. We have also brought human primary cells to India and have a sizable share of this market too. With emphasis on logistics, we posses our own cryocans. We were the first to introduce liquid nitrogen vapor phase cryocans for transportation. We created user awareness on the critical and delicate nature of transportation of cells and sub-zero temperature critical reagents. Q Has Krishgen BioSystems made any significant investments in infrastructure and manpower? In 2011, we established a pilot laboratory and manufacturing facilities with state-of-the-art equipment. Our current capacities for manufacturing ELISAs are around 72,000 plates per month. We have invested approximately 2 crore in instrumentation. Our research and development (R&D) effort is led by a team of six scientists. Since 2008, our aggregate R&D spend on product development has been approximately 12 percent of our total revenues. Q What are some of the emerging opportunities in the agri-biotech sector? We provide diagnostic solutions to the agri-biotech sector. Our belief is that with the world trend in food growth, the only avenue available is to apply biotechnology to this sector to boost growth and match the world's population. With a tenth of the population living in this region, agri-biotech growth is inevitable. Here again, we have positioned ourselves to offer diagnostics solutions as a vendor to the agriculture industry. Our genetically modified organism and plant pathology detection kits are well accepted. Our product launch has been a game changer in driving the prices down. We have also straddled and jumped the technology barrier by developing and introducing assays for gene event, which are under Genetic Engineering Approval Committee review and will be approved in 2012-2013. Q Are you looking for new distribution partners to increase your depth of market coverage? We actively seek distribution partners and plan to further increase our footprint across the country. As a company built in the ethos of science, we believe our partners are our face to the users. Hence, we believe in training our distributors not only for commercial marketing, but also for the technical inputs. Q Has the current economic crisis affected your business in any way? Tight budgetary spends in the US and Europe are a reality we must accept. We must emphasize the paradigm of quality first and then competitive prices to achieve success in the current economic scenario. It has been our experience that budgetary cuts offer greater opportunities. We expect a growth in business by over 40 percent in 2012-2013. Nayantara Som Banerjee in Mumbai ]]> <![CDATA['Our plug & play approach helps customers save cost']]> https://biospectrumindia.com/news/95/5698/our-plug-play-approach-helps-customers-save-cost.html https://biospectrumindia.com/news/95/5698/our-plug-play-approach-helps-customers-save-cost.html Fri, 11 May 2012 18:20:00 +0530 Ajay Dubey, director, marketing, Ingenesys Typically, installation of highly automated systems at a client site takes nothing less than a week or two. Pune-based, Ingenesys, has made an exception by reducing this turnaround time to approximately four days. The company has recently invested in a dedicated factory acceptance testing (FAT) center for live testing of their systems. The customers are given the opportunity to see these systems fully operational and tested before being installed at their respective facilities. In an interview with BioSpectrum, Ajay Dubey, director â€“ marketing, Ingenesys (a venture of the DD Enterprises), throws light on the company's strategy and major investments that could help customers achieve clearance of stringent regulatory supervision. Q Ingenesys has been catering to the biotech industry for many years. Which segment of the industry has been favorable for your business? Dubey: The entire Indian biotech industry has been favorable for us. This industry has two verticals: the conventional antibiotic and large-volume small-value fermented products and the small-volume large-value therapeutic proteins, or biologics. Operationally, the similarities between the two are few. Ingenesys straddles the whole chasm. The biotech industry in India is technology and regulations driven, IPR guarded, capital intensive, with a market that is still evolving, especially the biologics segment. Like the biopharmaceutical operations which have evolved primarily after delving in the conventional products, Ingenesys too has graduated from mass produced stainless steel equipment to precisely engineered automated systems that make routine human interface redundant. Our strength is our expertise in understanding the customers' technological needs, delivering their expectations and in programing validatable software which can pass the scanner of the US and European regulators. Q The vaccine sector is driving the growth of the biopharma industry in India. How is your company gearing up for that growth? The vaccine segment falls within what we generically call the biologics. They do not differ in any of the attributes, save the fact that the volumes being handled are smaller compared to other biologics such as insulin or monoclonal antibodies. Although we do not prescribe to â€œone design fits allâ€? approach, the vaccine production does not offer any bigger challenges than what we expect from the biopharma industry. Q What have been the achievements of Ingenesys over the past one year? We have had the opportunity of designing and supplying equipment and systems for a diverse range of products including monoclonal antibodies (mAbs), vaccines and blood plasma. The testing of all the equipment at our FAT center enables our customers to see their systems fully documented, operational, and tested before being installed at their facility. Our plug and play approach has enabled us to offer substantial savings to our customers with reduced turnaround time for installation and lower requirement of resources to complete these activities at the site. Q What were some of your key infrastructure-related investments? We have invested in a dedicated FAT center for live testing of our systems. We are in the process of upgrading our legacy systems by implementing an enterprise resource planning solution for streamlining all our processes for effective monitoring and control of our projects. We have planned substantial investments in imparting training to our team members to ensure our presence as a key player for meeting the requirements of the global biopharmaceutical industry. Q There are many biotech companies in India who are looking at monoclonal antibodies? Will that be a growth driver for Ingenesys? Monoclonal antibodies as a group brought in $51.16 billion revenue globally in 2010. New mAbs that are in development require extensive product-characterization for the product to obtain the necessary approvals for clinical trials to proceed and eventually to be released into the market. These two factors make the whole future of biopharma extremely exciting as well as challenging for us. We anticipate two changes to happen in India - structurally as well as philosophically. Structurally, upgrade of existing facilities and contract manufacturing is the way forward. We see opportunities in both. Philosophically, this is a game that needs serious players, as not only are the investments large for our clients, but also are the cost of errors that run into double-digit crore with time. Q How do you help your clients to comply with regulatory approvals? Offering and passing factory acceptance tests of the critical equipment of the operation is our ingrained strategy. Since we understand this, our designs and fool-proofing takes the center stage. Additionally, during the FAT we recommend that the client deputes its key operating personnel to get a full training on the system for both hardware and software. Q What is Ingenesys' future strategy? Upgrading ourselves with the latest trends and a continuous training for our front-and-back office staff will be both our capital and insurance. We hope to double our revenues by 2014. Nayantara Som Banerjee in Mumbai ]]> <![CDATA['India is trailing behind China in many aspects']]> https://biospectrumindia.com/news/95/8462/india-is-trailing-behind-china-in-many-aspects.html https://biospectrumindia.com/news/95/8462/india-is-trailing-behind-china-in-many-aspects.html Fri, 11 May 2012 18:18:00 +0530 Ashish K Dasgupta,vice-chairman, Association of Contract Research Organizations, India The clinical trials industry, which was once riding on the growth wave and dubbed as the 'sunshine sector' by market observers, now lacks a meticulous regulatory structure and is stung by delays in approvals of clinical trials. In an interaction with BioSpectrum, Ashish K Dasgupta, vice-chairman, Association of Contract Research Organizations (ACRO), India gets candid about the current predicaments prevailing in the Indian CRO industry and hides no bones about the need for a transparency in the system. He envisions ACRO India to be the apex body representing the clinical research industry in India. Excerpts of the interview: Q Globally, many biopharmaceutical companies are focusing on cutting down the cost of research and development (R&D) while bringing drugs to market faster. How should Indian CROs gear up towards this development?  Dasgupta:  To take a significant share of the global market as a result of biopharmaceutical companies cutting down budgets, the regulatory environment needs to change. The R&D productivity, which is key to the growth and success of the industry, has declined dramatically in the last few years in the US. The cost of developing and bringing a molecule to market is now estimated at $1.3 billion. However, company revenues are not growing fast enough to sustain such spending levels. The good news is that despite all negative reports, all Indian CROs have gone through international regulatory audits successfully. Q The fall in clinical trials in the US has resulted in increase of clinical trials in the emerging nations of the world. What has been the progress in India, especially compared with China? India is still trailing behind China in many aspects. While India has a market share of 2.20 percent, China has 2.83 percent of it. As of 2009, India is lagging behind China in terms of number of clinical trials too, with the total being 246 as compared to 316 in China. Between 2008 and 2009, the Indian clinical research market registered 9.60 percent decline in revenues while China's grew by 15.30 percent. Q 2011 saw a drop in the number of clinical trials approvals. Any particular reason for the decline? The numbers have decreased because we have become reactionary to various issues raised by the media and have not been able to defend our stand in the right manner. As a consequence, the approval process has become extremely slow. Q What are some of ACRO's current initiatives in dealing with the negative reports about the industry? ACRO is proactively conducting regional meetings with print media and sharing with them the reality of the situation in the country. In 2012-13, we intend to make ACRO a more robust body by implementing a code of ethics among the members and initiating a high level advisory board. Nayantara Som Banerjee in Mumbai ]]> <![CDATA[DST sets up ayurveda task force]]> https://biospectrumindia.com/news/95/1626/dst-sets-up-ayurveda-task-force.html https://biospectrumindia.com/news/95/1626/dst-sets-up-ayurveda-task-force.html Fri, 11 May 2012 18:14:00 +0530 The concepts of body constitution, digestive process of food in the gut and substrates in tissues, rejuvenation, body adaptation to seasons, degradation of habitat by human conduct, and taste as a chemical indicator are examples of the rich collection of cues that ayurveda provides for the modern investigator. But the research in ayurveda has been dominated by studies on medicinal plants and the development of herbal drugs, which has a large market growing at 15 percent per year. Therefore, in order to fill the gap between the basic research and ayurvedic biology, the Department of Science & Technology (DST), Ministry of Science & Technology, has constituted a task force under the chairmanship of Dr MS Valiathan, National Research Professor, Manipal University. The objective is to promote the application of basic sciences in the investigation of Ayurvedic concepts, procedures and products, and nurture the discipline of ayurvedic biology. Code verification tech gets govt nod A high-level task force on pharmaceutical manufacturing recommended the adoption of unique code verification technology and mobile SMS authentication for all domestic medicines produced in India. The task force, put together by the Union Health Ministry last year, undertook research on available track and trace technologies as part of an ongoing effort by the government to curb drug counterfeiting. The task force recommended this particular solution based on its viability and affordability in implementation across the pharmaceutical market in India. It also suggested the technology be implemented in several phases. The task force recommendation is now in the hands of the Indian government who will make a decision on whether or not to require this track and trace technology as an addendum to the Drug and Cosmetics Act. H1N1 virus hasn't mutated Seeking to dispel the notion that the influenza H1N1 pandemic virus is going to attain its worst mutated form, the Indian health ministry recently issued a statement that the situation with respect to instances of H1N1 is well under control and is being monitored. The ministry sought to clear air on the recent media reports by denying that the virus has mutated to a more virulent form or changed its character. World Health Organisation (WHO) while declaring Pandemic to be over in August 2010, had conveyed that the influenza H1N1 pandemic virus would take on the behaviour of seasonal influenza virus and continue to circulate for some years to come. Quoting the same, the health ministry statement issued on April 11, 2012 said that in the post-pandemic period, localized outbreaks of varying magnitude with significant level of H1N1 transmission are expected. India's first neat microalgal biodiseal run In an important development, the test-run of a fully loaded Tavera (a regular diesel vehicle) on neat (B100) â€œmicroalgal biodieselâ€? was conducted in New Delhi. The microalgal biodiesel was produced from a marine microalgal strain cultivated in a solar saltpan. The endeavour is the outcome of an ambitious project initiated in April 2010 under the (CSIR-NMITLI) program by CSIR and the Ministry of Earth Sciences (MoES) that seeks to develop a scalable process for production of biofuel from marine microalgae. Waving the green signal to the test run vehicle the union minister for science technology, Vilasrao Deshmukh, said, â€œIn a significant advancement in this NMITLI project, I am given to understand that the proof-of-concept for running a regular diesel vehicle on B20 biodiesel from marine microalgal source was achieved last year.â€? Scientists from nine partnering institutions spread across the country, such as Andhra University (AU), Vishakhapatnam; Calcutta University (CU), Kolkata; CSIR-Central Salt and Marine Chemicals Research Institute (CSIR-CSMCRI), Bhavnagar; CSIR-Indian Institute of Chemical Technology (CSIR-IICT), Hyderabad; Indian Institute of Technology, Khargpur (IIT-Kgp); CSIR-National Chemical Laboratory (CSIR-NCL), Pune; CSIR-National Institute of Oceanography (CSIR-NIO), Goa; National Institute of Ocean Technology (NIOT), Chennai; and CSIR-National Institute of Interdisciplinary Science and Technology (CSIR-NIIST), Thiruvananthapuram are participating in the aforesaid endeavour. ]]> <![CDATA[Congratulations! Dr K VijayRaghavan]]> https://biospectrumindia.com/news/95/2356/congratulations-dr-k-vijayraghavan.html https://biospectrumindia.com/news/95/2356/congratulations-dr-k-vijayraghavan.html Fri, 11 May 2012 18:11:00 +0530 Ch. Srinivas Rao The author is Editor of BioSpectrum srinivasch@cybermedia.co.in Let me take this opportunity to congratulate Dr Krishnaswamy VijayRaghavan, senior professor and director, National Centre for Biological Sciences (NCBS), Tata Institute of Fundamental Research, Bangalore. He has been elected as a Fellow of the Royal Society on April 19, 2012. Born on February 3, 1954, Dr VijayRaghavan, is an outstanding geneticist and traced the footsteps of his mentor Dr Obaid Siddiqui, who is currently a National Research Professor at NCBS, to become a Fellow. Dr Siddiqui was elected as a Fellow of the Royal Society in 1984. Dr VijayRaghavan is the 43rd Indian to be elected as Fellow of the Royal Society. The Royal Society was founded in 1660 to â€œrecognize, promote, and support excellence in science and to encourage the development and use of science for the benefit of humanityâ€?. Fellows are elected for life and some of the most famous Fellows from India include Dr Ardaseer Cursetjee, Dr Srinivasa Ramanujan, Dr Jagadish Chadra Bose, and Dr CV Raman. Dr Cursetjee was the first from India to be elected to the Royal Society. He was was elected in 1841. Mathematician Dr Ramanujam was elected in 1918 and Physicist Dr Bose in 1920. It is interesting to note that India has been producing about 5-6 Fellows every decade since the 1970s. The period 1980-90 saw eight scientists getting elected. Interestingly while the bulk (35 percent) of the Fellows have worked in the areas of physics, 28 percent of the Fellows have worked in the area of biology, medicine, etc. This recognition increases the stature of NCBS as a world-class institute. It is also an acknowledgement of India's research strength in the area of genetics. Dr VijayRaghavan has been applauded for his research on understanding the cellular and molecular principles of adult muscle development in Drosophila is widely recognized. He has married these studies with those on the development of the nervous system to study the control and development of movement. We are very honored to be closely associated with Dr VijayRaghavan, Dr Siddiqui, amongst other outstanding scientists during the last 10 years. Dr VijayRaghavan has served as a Jury member for selection of BioSpectrum India Awards in 2004-05 and the TR35 India Awards in 2009, while Dr Siddiqui was the Recipient of BioSpectrum Life Time Achievement Award 2010. Dr Raghunath Anant Mashelkar, another prominent scientist in the biotech circles, was elected Fellow in 1998. BioSpectrum is in its 10th year. There have been lots of changes in the biotech eco-system during these years and industry has grown and matured, but it has not got the recognition that it deserves. We have decided to take the lead in building â€œBrand Biotech Indiaâ€?. We are kickstarting this exercise with BSLSRG 2012 - Gateway to India's Life Sciences Industry with the theme around doing business with India. This would be circulated at BIO, Boston. We would also launch a new look and more informative report on the Indian bioscience industry in June 2012. This would capture Industry's performance from 2002 to 2012 and map the turning points and key milestones. I would urge you all to be part of this important exercise. It's time that we work cohesively. ]]> <![CDATA[Balancing science and management]]> https://biospectrumindia.com/news/95/1919/balancing-science-and-management.html https://biospectrumindia.com/news/95/1919/balancing-science-and-management.html Fri, 11 May 2012 18:06:00 +0530 ]]> <![CDATA[DNA research key to better future]]> https://biospectrumindia.com/news/95/1830/dna-research-key-to-better-future.html https://biospectrumindia.com/news/95/1830/dna-research-key-to-better-future.html Fri, 11 May 2012 18:05:00 +0530 Biochem Research Ms Bharathi Sriram vice president, R&D, GangaGen, Bangalore After more than seven decades since antibiotics first made their mark in medicine, today antibiotic resistance is cited as one of the most problematic issues. Taking a novel approach to solve this predicament is the team at GangaGen who is developing a phage protein P128 which can directly target the bacteria. Having led the crucial preclinical development of this novel protein, Bharathi Sriram, who rose from the ranks of a scientist to vice president, research and development (R&D), at GangaGen, is now gearing up for clinical trials of the P128 phage protein. With over 20 years of experience in the field ranging from preclinical development to process development, Sriram attributes the valuable diverse knowledge she gained at renowned companies, such as Astra Zeneca and Dr Reddy's Labs, to be an important factor in spearheading the P128 project. After completing her MSc in Clinical Biochemistry from the Institute of Basic Medical Sciences, Chennai, she cleared the Council of Scientific and Industrial Research (CSIR) exam and started scouting for labs to continue her research. Reminiscing about those days she says, â€œLike many people at that time, I had the 'DNA fever' and, I joined Dr Modak's Lab in Pune University where my work was related to methylation damage where we found an exclusive distinct protein that was released after methylation, for the DNA repair in virus. I could not characterize the protein but found that it was specific to this type of damage.â€? Following that, at AstraZeneca, Sriram worked on malaria under different platforms. Post this stint, she moved to the diagnostics division at Dr Reddy's Labs where she supervised quality control and the process development for biotherapeutics. In late 2001, an exciting concept changed things around for Sriram. â€œThe scientist in me won while making this decision,â€? she says about the move to GangaGen. â€œThe original concept of working on bacteriophages as a mechanism to combat bacteria was very fascinating. We looked at the proteins involved in the infection of the bacteria by the phage, and we came across phage structure-associated proteins that degraded the cell wall of Staphylococcus aureus. Further, using cloning techniques, we developed P128 or StaphTAME protein that possesses the catalytic domain of the phage and an S. aureus targeting domain, thus awarding it a very good bactericidal activity, effective against even methicillin and vancomycin resistant Staphylococcus strains.â€? P128 would be effective against those who carry a high risk for nosocomial infections, including those who frequently undergo dialysis or for elective surgeries. Sriram built and led the process and analytical development group at GangaGen where she was involved in evaluating the biochemical, biological and biophysical properties of the protein, and designed the manufacturing protocols as well. Citing the inexperience of the Indian regulatory authorities regarding novel products, Sriram is yet positive about the completion of the phase I and IIA clinical trials by next year to help bring StaphTAME in the market soon. Manasi Vaidya in Bangalore ]]> <![CDATA[Result-oriented research]]> https://biospectrumindia.com/news/95/2616/result-oriented-research.html https://biospectrumindia.com/news/95/2616/result-oriented-research.html Fri, 11 May 2012 18:03:00 +0530 Microbial Research Dr Girish Sahni director, Institute of Microbial Technology, Chandigarh Girish Sahni of Institute of Microbial Technology (IMTECH) is well known for his role in streptokinase research and for his contribution in making key technologies available to the biotech industry. He addressed the dire need to have indigenous protein cardiovascular drugs. And the products of his research have brought smile on the faces of millions of heart patients in India and abroad. Currently working as the director of IMTECH, Chandigarh, Sahni's areas of specialization are protein engineering, molecular biology, and enzymology. He began his research in 1984 when he was awarded PhD in protein biochemistry from the Indian Institute of Science, Bangalore. Following that, between 1985 and 1986, he went abroad for post-doctoral research involving genetic manipulation of animal viruses at the University of California, USA. Sahni continued to focus his research on protein engineering from 1986 to 1991 as a senior research associate and adjunct faculty at Rockefeller University, New York, and Albert Einstein College of Medicine, New York, respectively. Completing his overseas stint, he came back and joined IMTECH as assistant director in 1991. After working at various positions, he went on to become the director of the institute in 2005. Among the successful technologies developed by Sahni's group at IMTECH is the natural streptokinase product â€œSTPaseâ€? that was commercially launched by Cadila Pharmaceuticals in 2002. Sahni has also developed a third generation novel life saving drug (protein-engineered, therapeutically improved â€œclot-specificâ€? streptokinase) which has been patented worldwide and was licensed to US-based Nostrum Pharma in 2006 and Symmetrix Biotech, India. The drug is expected to be commercialized by 2013. Sahni's current research includes exploration of structure-function inter-relationships in proteins aimed at fundamental understanding, enzyme mechanisms, and process development for rDNA-based therapeutically important proteins. Besides finding place in the numerous national and international journals, Sahni's research work has generated four patents. He is a recepient of significant recognition, several awards and fellowships. Sahni was awarded Vasvik Award in biological sciences for the year 2000. He was conferred Council of Scientific and Industrial Research (CSIR) technology shield in 2001-2002 for natural streptokinase process development leading to successful commercialization. In 2002, he received the national biotechnology product and process development award from the Department of Biotechnology (DBT) and was the Ranbaxy awardee in pharmaceutical sciences in 2003. Besides being the fellow of Indian Academy of Sciences, Bangalore and National Academy of Sciences, Allahabad, Sahni is also fellow of the Association of Microbiologists of India. Sahni believes that incentivizing the translational research can do wonders for the product development. He feels that young scientists in India must do research that can leave long lasting impression on the minds of the common man.â€? Rahul Koul in New Delhi ]]> <![CDATA[PPP: Agri-biotech research gains pace]]> https://biospectrumindia.com/news/95/1486/ppp-agri-biotech-research-gains-pace.html https://biospectrumindia.com/news/95/1486/ppp-agri-biotech-research-gains-pace.html Fri, 11 May 2012 18:02:00 +0530 In this month's public-private partnership series, BioSpectrum features three ongoing research projects in the field of agricultural biotechnology. These are just a few of the many research efforts shaping the future of Indian agri-biotech. The BIPP funding from Department of Biotechnology has strengthened the joint project between Nirmal seeds and TERI to develop hybrid varieties of mustard by using marker assisted selection technology. The joint efforts of Krishidhan Seeds and Jawaharlal Nehru University to create transgenic Okra free from yellow vein mosaic virus has found support from SBIRI scheme of Department of Biotechnology. Bejo Sheetal Seeds is closely working with ICGEB to develop hybrid varieties of stress tolerant onion. The project is supported by BIPP. ]]> <![CDATA[New stress tolerant onion hybrids]]> https://biospectrumindia.com/news/95/1850/new-stress-tolerant-onion-hybrids.html https://biospectrumindia.com/news/95/1850/new-stress-tolerant-onion-hybrids.html Fri, 11 May 2012 18:01:00 +0530 Bejo Sheetal Seeds and International Centre for Genetic Engineering and Biotechnology are developing a new hybrid variety of stress tolerant onion In India onion is one of the most important vegetable commodities - the country ranks second in onion production globally. India produces about 15 tons onion per hectare, which is 25 percent of the highest global onion productivity in the US. However, one of the major challenges faced by the farmers in India is the large number of weed occurrence in onion crops which results in huge losses. Also, the cultivation of onion, which is done mostly in the Rabi season, when there is scarcity of irrigation water, adds to the production losses. To address this problem, Jalna-based Bejo Sheetal Seeds has initiated a project on creating herbicide and stress tolerant onion hybrid varieties in partnership with the International Centre for Genetic Engineering and Biotechnology (ICGEB), New Delhi. The project aims to apply the biotechnological tools to improve the productivity of onion. The project received support from the Department of Biotechnology (DBT) under Biotechnology Industry Partnership Partnership Programme (BIPP). The funding helped the company to carry out the validation of both herbicide tolerant and stress tolerant technologies and further utilization of the same for development of the onion products. According to B Mazumdar, vice president, Bejo Sheetal Seeds, although the grant amount is usually very low, the grant support from public partner institute to work together for the objective is important. â€œCertainly the loan amount with low interest encourages us to work on the projects where product commercialization is not certain,â€? adds Mazumdar. He calls the BIPP a great support. â€œWe believe in public private partnership for developing biotech products and this allows us to get guidance from the expert scientists of public institutes. The â€œpublic private partnershipâ€? will be helpful for the high risk technology deployment and commercialization in Indian biotech industry,â€? he says. Way forward The project initiated in March 2010 has been progressing well as per the work plan. The set milestones have been achieved with the progress indicator towards development of transgenic onion for herbicide and stress tolerance. Stress tolerance particularly from drought and salinity is becoming an important factor to avoid crop losses and low yields in most of the vegetable crops, in particular, onion. Addressing weed management by developing transgenic variety would be a better alternative in near future considering the success of herbicide tolerant variety cultivation globally. â€œTransgenic technology deployment is encouraging for both the traits being developed in this project. A few technologies have been commercialized in food crops such as transgenic papaya in Hawaii, transgenic beans in Brazil, and golden rice which are on the verge of commercialization. Bt Brinjal is ready for commercial cultivation although it is taking time to make the same available to the farmers. There are great chances of increasing onion production if transgenic onion is deployed with herbicide and drought stress tolerance,â€? concludes Mazumdar. Rahul Koul in New Delhi ]]> <![CDATA[Virus-free Okra]]> https://biospectrumindia.com/news/95/2248/virus-free-okra.html https://biospectrumindia.com/news/95/2248/virus-free-okra.html Fri, 11 May 2012 18:00:00 +0530 Krishidhan Seeds and Jawaharlal Nehru University are developing transgenic okra that is free from yellow vein mosaic virus. The project is being supported by SBIRI scheme of Department of Biotechnology Yellow vein mosaic virus is one of the major banes in okra production which is a popular vegetable across India. The earlier varieties of okra, known as bhindi in Hindi, derived from Manihot genus used to show excellent resistance. However, the resistance now seems to be wearing off and the viral disease has become prevalent, causing severe problems to farmers engaged in okra cultivation. Further, the lack of genome information in okra makes it difficult to devise alternative solutions to find resistant genes in the plant. Jalna-based Krishidhan Seeds has partnered with Jawaharlal Nehru University (JNU), New Delhi, to develop a novel and stable resistance against yellow vein mosaic virus by genetically modifying the okra plant with state-of-the-art technology. Professor and researcher at life sciences department of JNU Supriya Chakraborty's research targets at interfering the interactions between plant viruses and their hosts as well as at developing strategies to control begomoviruses in plants. Under the joint project, JNU and Krishidhan will develop the technology and Krishidhan will use its resources for development of resistance against mosaic virus in its elite okra hybrids. Talking about the partnership, Anup Karwa, director, life sciences, Krishidhan Seeds, says, â€œOur partner in the project from JNU is an enthusiastic virologist, Supriya Chakraborty, who is excited about the concept and at the prospect of partnering with us. Hence, a joint project was drafted using the complementary competence of our labs. Expertise of JNU and Krishidhan's excellent infrastructure and an extraordinary team of accomplished biotechnologists with expertise in recombinant technology, marker-free technology, and crop transformation, will help us achieve the envisaged objective.â€? However, Karwa adds, â€œThere is a dire need to have robust products based on our indigenous technologies. A partnership in this area will ensure that the excellence in our public sector institutes get converted into usable technologies and useful products. The discovery and development of new genes and introducing them into elite varieties and hybrids will not only resolve the intractable problems in crop production, but will also make up for the lack of existing genetic diversity in many cultivated species.â€? The project has been funded by Small Business Innovation and Research Initiative (SBIRI) of Government of India's Department of Biotechnology. Talking about its importance, Karwa says, â€œThe support comes as a prestigious award recognizing the inventive strengths of Krishidhan and JNU. This encourages us to undertake more indigenous and innovation-driven research aiming to generate novel IPs in the domain of agri-biotech and bring more technology choices for the Indian farming community.â€? Next step The final grant was received in January 2012 and the project is moving as per plan. The future relevance of project is important for securing the sustainable vegetable production. Karwa adds optimistically, â€œBy the time we develop a product and be ready for subjecting it to require regulatory approvals for a genetically modified organisms, new science-based mechanisms will be in place.â€? Rahul Koul in New Delhi ]]> <![CDATA[Nutritionally improved mustard hybrids]]> https://biospectrumindia.com/news/95/7264/nutritionally-improved-mustard-hybrids.html https://biospectrumindia.com/news/95/7264/nutritionally-improved-mustard-hybrids.html Fri, 11 May 2012 17:58:00 +0530 Jalgaon-based Nirmal Seeds and The Energy and Resources Institute of New Delhi are developing hybrid varieties of mustard by using marker assisted selection technology Mustard oil is generally preferred due to its characteristic pungency, but at the same time the oil has high amounts of erucic acid which is anti-nutritional. The oil cake too has high level of glucosinolates which makes it unfit as the cattle feed. So far the genetic improvement programs in Indian mustard have targeted only the yield related traits. However, there is a need for developing quality mustard hybrids with nutritional value which are fit for cattle consumption. Taking a step in this direction, in March 2011, Jalgaon-based Nirmal Seeds initiated a joint project with The Energy and Resources Institute (TERI), New Delhi, on nutritionally improved mustard using marker assisted selection (MAS) technology. The project is aimed to improve the quality of mustard oil and cake by reducing the erucic acid and glucosinolate content. With Brassica juncea being the most widely cultivated Brassica species in India, one of the major achievements of this project is expected to be able to develop double low traits in the plant species. The project valued at nearly 210.34 lakh, received the Biotechnology Industry Innovation Partnership Programme (BIPP) funding to a tune of 68.57 lakh (34.29 lakh as aid and 34.28 lakh as loan) from the Department of Biotechnology (DBT). TERI will be carrying out molecular validation of the double low traits of the Brassica progeny arising from the backcross breeding program at Nirmal Seeds. The research and development (R&D) team at Nirmal Seeds has been simultaneously carrying out analytical validation of erucic acid and glucosinolate content at TERI by using gas chromatography (GC) and high performance gas chromatography (HPLC). The F1 progeny of the crosses has been raised and leaf DNA samples of raised F1 population were sent to TERI for validation of double low traits using molecular markers. Microspore culture laboratory has been set up at Nirmal Seeds for haploid plant production, which is one of the objectives required for fixation of homozygous characters at BC3 generation. Highlighting the importance of public private partnership, RO Patil, managing director, Nirmal Seeds, says, â€œBoth the public and the private sector organizations have their own specialized skill sets and strengths. Public private partnership program brings this complimentary strength together and can play a crucial role in dealing with big agricultural challenges. While public sector provides expertise in plant science genomics and bioinformatics, the private organizations contribute to crop improvement through hybrids, delivery of the product, and services and marketing.â€? Way forward The anti-nutritional properties of the Indian mustard cultivars due to high erucic acid and glucosinolate content have resulted in its limited preference in southern and central India as well as in international market. This crop accounts for nearly one-third of the oil produced in India, making it India's key edible oilseed crop. Till date no double low varieties of B. juncea have been commercially released in India. Once the new hybrids are developed, they are expected to have wider acceptance and increased utility both as edible oil and cattle feed. Rahul Koul in New Delhi ]]> <![CDATA[Strategic research reigns India-Australia collaborations]]> https://biospectrumindia.com/news/95/5377/strategic-research-reigns-india-australia-collaborations.html https://biospectrumindia.com/news/95/5377/strategic-research-reigns-india-australia-collaborations.html Fri, 11 May 2012 17:42:00 +0530 There has been a significant increase in industry-to-academia and industry-to-industry interactions between India and Australian bioscience communities Last five years have witnessed many steps taken by the respective industries and governments in India and Australia to strengthen mutually beneficial partnerships in the area of biotechnology. In 2007, Australia's Deakin University in Victoria signed a memorandum of understanding (MoU) with India's Biocon for joint multidisciplinary research focused on biotechnology and bioscience. Another notable example of Indo-Australian collaborations is between Strides Arcolab and Melbourne-based Ascent Pharmahealth. Strides first invested in Ascent Pharma in 2008 and in January 2012 sold Ascent to Watson Pharma. Strides-Ascent deal could be a good case study for what Indian and Australian companies have gained from mutual collaborations. Indian healthcare leader, Zydus Cadila and Australia-based Symbion have signed an MoU for construction and operation of manufacturing facilities in India. The Indian diversified major ITC acquired Australian agri-biotech company Technico as part of its strategy to strengthen its foods business. The Mumbai-based Ipca Laboratories acquired Australian formulation product dossier registration-cum-distribution company (now Ipca Pharma Australia) to enable it to register formulations in Australia. The clinical trial companies based in Australia seem to be much interested in utilizing the offerings of the Indian market. Lisa Nelson, deputy CEO, Nucleus Network, says, â€œIndia offers very good opportunity for clinical trial companies. We have collaborated with many big pharma companies in India such as GlaxoSmithKline and Novartis. At present our India focus is more on the early phase clinical trials and healthy volunteers because of safety considerations. We are currently doing groundwork in India and are on the lookout for potential partners. Compared to China, where it takes almost 12 months, India is much better in terms of regulatory approvals. India is slowly reforming its existing structure whereas China is a closed market.â€? The medical technology companies, such as Muranex, are in lookout for Indian investments. Dr Maurice Fabiani, CEO and MD, Muranex says, â€œIn India we are trying to tie up with the potential strategic partners to ally and raise investment capital. We are well aware that the Indian market is doing quite well and has registered a lot of growth and experience over the passage of time. However, a bit more seems to be required at the regulatory front.â€? Australian companies are looking positively at the change in India's regulatory framework. Roger Kalla, founder and director, Korn Technologies, Victoria, says, â€œIndian market is huge and we can see clearly the increased role in agri-biotech sector. The seed companies have seen great growth in India and now there are various opportunities to share the knowledge in agricultural technology development. As far as regulatory issues are concerned, it may take some time. However, like in Australia where after some wait genetically modified (GM) Canola has been approved and now GM wheat will be tested, we are hopeful that India will catch up soon.â€? Indoâ€“Australian Biotechnology Fund Project Project Research Partners Funding Development of selenazole drugs as a novel class of anti-cancer agents targeting the immune system University of New South Wales and Indian Institute of Science, Bangalore $300,000 Therapeutic approaches to augmentation of adult cardiac stem cells Victor Chang Cardiac Research Institute and Institute for Stem Cell Biology and Regenerative Medicine, Bangalore $400,000 Development of a novel bioreactor and cell sorter for more efficient production of stem cell culture Monash University and Indian Institute of Technology, Mumbai $299,539 Production of omega-3 concentrates for functional foods, pharmaceuticals and nutraceuticals Deakin University and Centre for Cellular and Molecular Biology, Hyderabad $298,755 Structure-based design of malaria vaccines to elicit stronger immune responses Monash University and Indian Institute of Science, Bangalore $299,340 Identifying and testing molecules used to manipulate multiple genes to improve temperature tolerance in plants The University of Queensland and International Centre for Genetic Engineering and Biotechnology, New Delhi $299,700 Collaborative laboratory and clinical research on the role of lactoferrin derived from cow's milk. The University of Sydney and Postgraduate Institute of Medical Education and Research, Chandigarh $11,200 Natural RNA interference to combat disease and make aquaculture more economically and environmentally sustainable James Cook University and Karnataka Veterinary Animal and Fisheries Sciences University, Bangalore $294,099 (Source: AusBiotech) Research benefits India and Australia share challenges in areas such as agriculture, water, energy, and healthcare and have complementary strengths in other fields as well, including nanotechnology and astrophysics. There are a significant number of research collaborations between Australian and Indian universities, including programs at the University of Melbourne, Monash University, Queensland University of Technology, and Queensland Institute of Medical Research. A good example of successful research collaboration is Deakin India Research Initiative (DIRI), an expansion of Deakin University's ongoing development of research models to bridge the gap between academia and industry. This initiative plans to enable the rapid increase in manufacturing and knowledge industries which is needed for growing India's economy. Under the DIRI model, higher degree by research (HDR) candidates are based at an Indian research institution with day-to-day supervision provided by a local researcher and a Deakin academic staff who serves as principal supervisor. The candidate visits Australia for a period of six months to conduct research. DIRI has been working with 13 Indian research partners, including companies such as Biocon, Indian Oil, Vimta Labs, and labs of Council of Scientific and Industrial Research. Australia's strength Australia has high quality science capacity to forge international partnerships and a transparent and efficient regulatory regime. The country has a strong culture of research and, thus, can train large numbers of Indian nationals in its biotech programs. On the regulatory front, Australia's fast tracked regulatory approval process could be a major plus for Indian companies. The Clinical Trial Notification (CTN) scheme enables streamlined ethics approval for initiation of clinical trials, with 99 percent of trials able to begin within a week of being registered. The close alignment of Australia's regulatory and legal frameworks (practice and standards) to the US and EU means that products successfully trialed in Australia will have immediate transferability to these markets According to professor Peter Hodgson, director, Institute for Technology Research and Innovation (ITRI), Deakin University, Australia, â€œWith strong biotech and information technology skills, India has enormous potential. By shifting the focus on future technologies such as bionanotechnology, India can leapfrog China in development. Australia has developed one of the best healthcare systems in the world that spreads over a large area. Extensive work is happening at Deakin in lifestyle-related diseases such as diabetes and obesity. India has to face the lifestyle-related issues as the young population in the country is more prone to these diseases due to their affinity towards Western food habits.â€? Deakin University has also entered into a research partnership with The Energy and Resources Institute (TERI) and has established TERI Deakin NanoBiotechnology Research Centre in New Delhi. Researchers at Deakin University's ITRI bring excellence and expertise in the design and characterization of novel nanomaterials to the center, while TERI researchers in the Biotechnology and Management of Bioresources Division (BMBD) bring extensive experience in biotech applications in the field of pharmacology, food, agriculture, and environment. Within five years, the center will have about 70 researchers, including 50 PhD students enrolled at Deakin and co-supervised by Deakin and TERI staff. At the government level, Australia-India Strategic Research Fund (AISRF) is Australia's largest fund dedicated to bilateral research and one of India's largest sources of support for international science, providing $65 million over eight years from 2006â€“07. The Indo-Australian Biotechnology Fund (IABF) is a significant component of the AISRF and so far five rounds have gone through. The priority areas for the projects include neutraceuticals, vaccines and medical diagnostics, stem cells, transgenic crops and marker assisted breeding, and bioenergy. In May 2011, AISRF announced the sixth round with eight new projects within the IABF (see Indoâ€“Australian Biotechnology Fund Project). Under the program, the Department of Biotechnology (DBT) and Australia's Department of Innovation, Industry, Science and Research will soon start joint research in the defined priority areas mentioned above. Industry associations One of the most recent examples of industry playing a major part is the Victorian Government Super Trade Mission to India in February 2012. Hosted by Confederation of Indian Industry (CII), this mission represented over 24 companies from various life sciences and healthcare segments. Vibhav Garg, head, life sciences, CII, says, â€œCII facilitated business-to-business meetings for Australian companies with more than 24 Indian counterparts in New Delhi and Mumbai. Along with State Government of Victoria, CII is following up with Indian and Australian companies to help them get their dialogue matured.â€? India advantage India is a capable and increasingly dynamic player in international science, technology and research, both in publicly-funded research and in the private sector. The Indian biotechnology industry is one of the country's fastest-growing sectors. It has been growing at a rate of 20-25 percent per annum for the last three years. The easily available, cost effective and knowledgeable resources also make India an attractive destination for outsourcing research activities. The potential areas that are emerging as key strengths for the Indian biotechnology sector include research services and clinical trials, bio-IT data management, biogenerics and biomanufacturing, vaccines, diagnostics, biofuels, and agri-biotech. Besides CII, the Association of Biotechnology Led Enterprises (ABLE) has also been doing its bit on the partnership with Australian industry. It has signed an MoU with AusBiotech, Australia's biotechnology industry organization that represents more than 3,000 members, to promote bilateral business between the two countries. AusBiotech has led business missions to India over the recent years with more than 30 companies and universities participating in a program of business seminars, site visits, and networking events in Hyderabad and Bangalore. Anna Lavelle, CEO, AusBiotech, believes that there is a need to leverage the complementary strengths in India and Australia. She says, â€œWe have been showcasing the opportunities of companies in both countries for several years and believe that the best is yet to come. The greatest increase in engagement occurs after meeting partner organizations at conferences, such as Bangalore India Bio or the AusBiotech conference, where business matching and personal relationships are central to partnering.â€? The active involvement and participation of industry organizations and government agencies from both India and Australia, will go a long way in establishing and building a strong foundation to the growth of bioscience industry in each region. Rahul Koul in New Delhi ]]> <![CDATA[Plants contain health secrets for functional foods]]> https://biospectrumindia.com/news/95/1695/plants-contain-health-secrets-for-functional-foods.html https://biospectrumindia.com/news/95/1695/plants-contain-health-secrets-for-functional-foods.html Fri, 11 May 2012 17:39:00 +0530 By Dr Suman PS Khanuja, chief mentor and director, NutraHelix Biotech There is a clear gap between what an aware consumer would like to have and what the nutraceuticals and functional food products in the markets are. If we consider the mismatch of available and desired nutraceuticals as an opportunity to innovate, the path is clear for technological interventions. The consumer demand is and will be for good taste and texture in healthy foods. This clearly places the technological challenge for innovation to retain the taste, texture, organoleptic characters, and cooking quality in such nutra foods. Contrary to this, however, most of the available functional foods lack some or all of these features. The world has witnessed a transformation of â€œgoing digitalâ€? in recent past but the immediate future is for the world to â€œgo veganâ€?, that is, beyond vegetarian or herbal. The vegetation that will steer this transformation is not limited to medicinal herbs alone but to the whole plant kingdom. Opportunities galore The nutraceuticals sector poses a ready-to-utilize challenge to research with agriculture. The man behind green revolution, Nobel laureate Dr Norman Borlaug had once expressed, â€œPlants don't speak, they just whisper, you have to be real close to them to understand.â€? These words in my understanding make the basis for â€œsecondary agricultureâ€?. The aim through tertiary agriculture would be not only to enhance the value of agricultural products, but also to elevate their use in preventive healthcare. With traditional diversity in food habits and the range of processes and recipes used by communities in preparing meals for health, it is an advantageous situation in India for nutraceuticals' business. The recipes and ingredients of meals are the gateway to invent health ingredients and innovate nutraceuticals-based food formulations with desired organoleptic properties combined in likeable edible formats. According to Frost & Sullivan and BCC Research sources, the global nutraceuticals market is valued at $149.5 billion in 2011 and is predicted to rise to almost $207 billion by 2016. In this, Indian nutraceuticals market is valued at approximately 7,400 crore ($1.48 billion) in 2011 (about 1 percent share) which is anticipated to be around 13,655 crore ($2.73 billion) by 2016 (about 1.32 percent share). Functional foods are considered to be the quickest growing category till 2015 followed by dietary supplements. However, dietary supplements, specifically herbal and dietetic supplements, will form the greatest opportunity areas for nutraceutical manufacturers, driven by growing demand from an evolving consumer base. Unfortunately, India's positioning in the global market has not streched beyond one or two percent. This could be because of the lack in the vision and strategy to achieve more than what has been targeted. The only way to target India's positioning as a visible giant player will be to create clear investment priority of next plan in nutraceuticals research and development (R&D). Therefore, supporting different ideas of inventoin and innovatoin will facilitate converting gaps into technologies.  About the author Suman Preet Singh Khanuja , chief mentor, is translating his innovation in science by shaping up a novel venture as a research driven startup, NutraHelix Biotech, in the nutraceuticals sector. He has served as former director, Central Institute of Medicinal and Aromatic Plants (CIMAP India) and was elected the fellow of National Academy of Science, India (FNASc) and National Academy of Agricultural Science (FNAAS). He is also an eminent advisor to the biotech industry in India. ]]> <![CDATA[Indian healthcare industry needs a change]]> https://biospectrumindia.com/news/95/6169/indian-healthcare-industry-needs-a-change.html https://biospectrumindia.com/news/95/6169/indian-healthcare-industry-needs-a-change.html Fri, 11 May 2012 17:37:00 +0530 By Dr Raja B Smarta, founder and managing director, Interlink Marketing Consulting, India The healthcare industry in India needs a shift from the current reactive healthcare system instituted by pharmaceuticals to a more proactive healthcare system that defends the patient and gives way to provide proactive and preventive care. In India, preventive care is not as effective as it could be. Basic Indian healthcare model is built around general practitioners, specialists, and hospitals who are waiting for sick people to come to them. As the entire segment has become market and environment focused and patient centric, being just a provider would not lead the way forward. Innovation in biotech Biotechnology, in recent times, is widely employed in nutraceuticals to make food better, safer, inexpensive, and tastier. The food technologists are researching various tools to increase the volume of vitamins and minerals in foods which can help eliminate certain ailments, and provide several health benefits. The ingredients must be delivered to the customer in a form that tastes good, is stable, and bioavailable. However, many ingredients sensitive to the manufacturing process have their own unpleasant flavors or colors or adversely affect product stability. The food industry has begun to invest in innovative delivery technologies to overcome these problems. These delivery systems also have the potential to reduce the costs associated with food processing. The last five years have seen the pharma and biotech industries shift their business models from internally-focused research and development to external â€œopen networkâ€? models. The overarching business model for the food industry is evolving into something that more closely resembles the hierarchical structure of biotech in which networks, contract research organizations, in-licensing, and acquisition play a greater part in product development. Nutraceutical biosimilar companies will need to overcome numerous hurdles. The technologies need to be developed in such a way that it would be able to make molecule as close as possible to the innovator's molecule with similar safety and effectiveness. The successful biosimilar companies will be those that get a headstart in resolving practical issues in India. Products Algae-based products are categorized in polysaccharides, carotenoids, and vitamins and minerals. Polysaccharides, mainly from the brown and red seaweeds, are used to produce agar, alginate, agarose, and carragheenan. Carotenoids are derived from ÃŸ-carotene and astaxanthin while vitamins and minerals are derived from chlorella and spirulina. Majority of phytochemicals that are important nutraceutical ingredients are poorly soluble by the human body. Thus to overcome these, nanoemulsion technology is used to entrap the compound of interest into a food matrix, for example, the Ubisol-Aqua delivery system technology from Zymes. Other products including biliproteins, vitamins, amino acids, sugars, and sterols too have great potential in nutraceuticals through biotechnology. EID Parry nutraceuticals, Yakult Danone (India), Advanced Enzymes Technologies, Tata Chemicals, and Sami Labs are few organizations working in the space of biotechnology applications in nutraceuticals.  About the author Raja B Smarta is the founder and managing director of Interlink Marketing Consulting, a leading business and performance consultancy for entrepreneurs and corporates for pharmaceuticals, nutraceuticals, and healthcare companies. Having spent over 43 years in pharmaceutical and health sciences industry, he has many brands to his credit in pharmaceuticals. ]]> <![CDATA[Biotech nutraceuticals is the way forward]]> https://biospectrumindia.com/news/95/3346/biotech-nutraceuticals-is-the-way-forward.html https://biospectrumindia.com/news/95/3346/biotech-nutraceuticals-is-the-way-forward.html Fri, 11 May 2012 15:30:00 +0530 By Dr Dilip Ghosh, director, Nutriconnect, Australia Food has been used as a pharmaceutical agent to treat diseases since time immemorial and the pharmaceutical use of food is the basis of concept of nutraceuticals. Although there is no clear difference between nutraceuticals and functional foods, the basic difference between them is in the form in which they are presented. Biotechnology in food and nutrition business The most ancient form of biotechnology is fermentation, which involves use of microorganisms such as yeasts for the production of wine, vinegar, and bread. Dairy products such as yogurt and cheese were produced by lactic acid bacteria and molds. Although these techniques are still used, the cultures that were used in ancient times have been modified to provide high-quality products with increased yield. Modern food or nutraceutical biotechnology has evolved into a billion-dollar industry, with the promise of producing foods that provide functions beyond the basic nutrients they contain. These functional foods or nutraceuticals have become increasingly important to consumers who are interested in the health benefits of functional foods for prevention of illness and chronic conditions. Recent development of nanotechnology and its limited application has revolutionized the entire chain of food and nutrition, particularly in the field of delivery and packaging systems. The reported benefits of the new biotechnologies span from reducing environmental damage to improvements in animal welfare, farm productivity, product quality, and human health but there seems to be hesitancy in adoption of such technologies by farmers and food companies. Biofortification of staple crops through modern biotechnology can potentially help in alleviating malnutrition in developing countries. Several genetically modified crops, including rice, potatoes, oil seeds, and cassava, with elevated levels of essential nutrients; reduced levels of anti-nutritional factors; and increased levels of factors that influence bioavailability and utilization of essential nutrients are advancing through field trial stage and regulatory processes towards commercialization. The successful introduction of the biofortified crops would have a significant impact in reducing malnutrition and the risk of chronic disease in developing countries. Consumers and regulation An Australian study on consumer attitudes towards biotechnology has shown the consumers to have mixed, but on average, less positive attitude toward biotechnology. Many consumers in the US and elsewhere are unaware of the widespread use of biotechnology, the potential advantages of the genetic techniques, and the safety and regulatory procedures used before a product is approved for commercial use. The overall tone of public attitude towards novel food technologies is one of wariness, unease, uncertainty, and sometimes outright negativity. There is no regulatory scheme for functional food per se, but functional food products are clearly subject to most of the federal regulations. If a functional food product is marketed for a therapeutic purpose (for instance, to treat a disease), it will be subject to regulation as a â€œdrug.â€? If a product is subject to regulation as a â€œfood,â€? it may be further classified as a conventional food, dietary supplement, food for special dietary use, or medical food, depending upon its intended use. The production of pharmaceuticals with recombinant DNA technology has enjoyed significant successes over a quarter century, with minimal controversy. However, the use of recombinant DNA-modified plants for food, feed, and environmental applications has not fared that well. These shortcomings have helped to generate â€œThe Big Lieâ€? that recombinant DNA technology applied to agriculture and food production is unproven, unsafe, untested, unregulated, and unwanted. Those misconceptions have given rise to unwarranted opposition and distorted public policy. The issue needs to be tackled globally with the help of academicians, regulators, industries, consumers, and policy makers. Wellness Breakthrough biotechnology research is providing new applications for nutraceuticals and functional foods in health and wellness platforms. Over the last few decades, nutraceuticals have filled the nutrient gap for consumer health but the level of science and discovery has been limited. â€œThe needs of today's consumers are multidimensional and they are seeking optimal health, not medication,â€? said a leading nutritionist. Advanced biotechnology tools that can provide greater science is now available to an industry that can deliver wellness and health quickly to the consumer. It has been argued that biotechnology is neither good nor bad, and it has the potential to alleviate or aggravate the impact of agriculture on the environment to improve human and animal nutrition or to pose danger to human or animal health. The challenge is thus to develop, supply, and manage biotechnology for the benefit of humankind and the environment. The solutions proposed to tackle this challenge include: Promotion of research and market development for life sciences and biotechnology applications and the â€œknowledge-based bioeconomyâ€? Fostering competitiveness, knowledge transfer, and innovation from the labs to industry Encouraging informed societal debates on the benefits and risk of life sciences and biotechnology. Ensuring a sustainable contribution of modern biotechnology to agriculture. Improving the implementation of the legislation and its impact on competitiveness. (This article includes excerpts from Ghosh, D et al. (2010), Biotechnology in Functional Foods and Nutraceuticals, CRC Press, USA.) About the author Dilip Ghosh is director at Nutriconnect, Sydney; coordinator, regulatory and projects, SOHO-Flordis International, Australia; and honorary ambassador, Global Harmonization Initiative (GHI). He is one of the pioneer researchers in the evaluation of the health claims opportunities of potential functional food ingredients through an evaluation of the current scientific evidence base and related claims, and provides commentary on gaps in science, including potential requirements for research. ]]> <![CDATA[Biotech drives wellness]]> https://biospectrumindia.com/news/95/2290/biotech-drives-wellness.html https://biospectrumindia.com/news/95/2290/biotech-drives-wellness.html Fri, 11 May 2012 15:28:00 +0530 Indian nutraceuticals market to reach $2.73 billion in 2016 The Indian nutraceutical market is estimated to grow at a CAGR of 13 percent and top $2.73 billion in revenue by 2016. Functional foods will be the quickest growing category till 2015 followed by dietary supplements. Dietary supplements, specifically herbal and dietetic supplements, will form the greatest opportunity areas for nutraceutical manufacturers, driven by growing demand from an evolving consumer base, says a report from Frost & Sullivan. The Indian nutraceutical market is dominated by pharmaceutical and fast-moving consumer goods (FMCG) giants. While pharma companies are strong in dietary supplements such as vitamin and mineral supplements, FMCG companies dominate the functional foods space. A report by Frost & Sullivan and the 7th Nutra India Summit Conference Secretariat says, â€œThe Indian Nutraceutical market was valued at $1,480 million in 2011. Dietary supplements was the largest category accounting for 64 percent of the nutraceuticals market, driven primarily by the pharmaceutical sector in the form of vitamin and mineral supplements. The global nutraceutical market in 2011 was estimated to be $149.5 billion, with US, Europe and Japan being the largest regional markets accounting for nearly 93 percent of the global Nutraceutical demand. These markets are nearing maturity, with exceedingly high per capita spends on nutraceuticals products. This is forcing nutraceutical manufacturers to look at developing countries such as India and China, which have considerably lower per capita spends on nutraceutical products, as key growth regions for their nutraceuticals portfolio. Increasing disposable income and standards of living, aggressive retail marketing, increasing urbanization and awareness of functional benefits are driving the nutraceutical market in India. On the contrary, the market has some restraints such as lack of product credibility, unclear and ambiguous regulations, overcrowded product market, and lack of products catering to the Indian consumer. Narayan Kulkarni in Bangalore ]]> <![CDATA[Drug resistance keeps Malaria threat alive]]> https://biospectrumindia.com/news/95/2425/drug-resistance-keeps-malaria-threat-alive.html https://biospectrumindia.com/news/95/2425/drug-resistance-keeps-malaria-threat-alive.html Fri, 11 May 2012 15:07:00 +0530 With nearly 70 percent of the population at risk and increasing resistance to anti-malaria drugs, India can no longer ignore the threat from malaria The current anti-malaria market is close to 450 crore with an annual growth rate of 17 percent, says the ORG IMS November 2011 report. According to statistics available with the directorate of National Vector Borne Disease Control Programme, close to 12 lakh cases of malaria were reported in India till December 2011 of which 436 were cases of deaths. Increasing drug resistance is a possible cause for the continued rise in cases of Plasmodium falciparum in recent years, gradually increasing from 39 percent in 1995 to above 50 percent in 2008. Around 50 percent (6.4 lakh cases) were caused by the single-cell parasite Plasmodium falciparum. With P. falciparum, which causes the most dangerous forpotentially spreadms of the disease, becoming resistant to the drug chloroquine, artemisinin-based treatments have become popular. Globally, the number of courses of artemisinin-based therapies (ACT) procured by the public sector jumped nearly sevenfold between 2005 and 2006, and then more than doubled, reaching 181 million in 2010, according to the World Malaria Report 2011. The demand for these drugs was around 287 million treatments in 2011 and is expected to touch 295 million courses in 2012. Resistance causes worry â€œA looming threat to malaria control is the emergence of parasites that are resistant to anti-malarial medicines,â€? stated the World Health Organization (WHO) in its â€œGlobal Plan for Artemisinin Resistance Containmentâ€? published in 2011. The strains that are resistant to even artemisinin have emerged in parts of South East Asia and could potentially spread. Some facts about malaria Malaria largely affects people in the lower strata of society; thus cost of therapy influences the choice of treatment Seasonal trends peak during monsoon (August-September) Empirical therapy with chloroquine, pyrimethamine and sulfadoxine delivered without RDTs or Microscopy. Artemether and Lumefantrine formulation gaining momentum as first-line treatment in endemic areas For instance, child mortality in Africa increased as P. falciparum strains that were resistant to chloroquine spread in the continent in the 1970s and the 1980s. Raising the important issue, Virander S Chauhan, director, International Centre for Genetic Engineering and Biotechnology (ICGEB), says, â€œThere have been reports of resistance in Cambodia and Thailand, and if it reaches Myanmar and the north-eastern part of India, then things can get very messy.â€? Delivering artemisinin and its derivatives as monotherapies, instead of as a cocktail with another drug, can cause resistant forms of the parasite to arise and spread. Although oral artemisinin-based monotherapies are effective when taken as a full seven-day course, patient often stops taking them after a few days when the symptoms subside. Parasites that are sensitive to the drug get eliminated, allowing drug-resistant strains to proliferate and get transmitted to other people. WHO, in 2006, called for a halt on use of oral artemisinin monotherapies for treating uncomplicated malaria. A year later, a resolution was adopted by the World Health Assembly, WHO's apex decision-making body, that urged its member states to â€œcease progressivelyâ€? the provision, in both public and private sectors, of such monotherapies and promote the use of ACTs. However, according to the latest World Malaria Report 2011, 25 countries are still allowing the marketing of these products and 28 pharmaceutical companies, as against 39 a year ago, are making these drugs. The report has also warned that there are Indian pharmaceutical companies among those manufacturing and marketing drugs that are likely to foster resistance to artemisinin in the malaria parasite. The Drug Controller General of India (DCGI) initiated action earlier this year to stop the production and export of these drugs. It wrote to all state drugs controllers requesting them to cancel licenses for manufacturing oral artemisinin-based monotherapies with immediate effect. Challenges galore Correct diagnosis through microscopy Rising P. falciparum burden Fatty foods is a requirement for adequate bioavailability of Artemether and Lumefantrine and other anti-malarials; hence treatment failure is common Choloroquine resistance is widespread in India Emerging resistance to artemisinin, notified particularly in South East Asia Addressing the menace According to WHO, India is of greatest concern as there is widespread DDT-resistance (dichlorodiphenyltrichloroethane) and patches of resistance to pyrethroid and organophosphate (malathion). The WHO has recommended that an ACT should be first-line treatment for uncomplicated malaria caused by P. falciparum. The two-drug combination reduces chances of the parasite developing resistance. Moreover, a three-day course of a recommended ACT generally clears the parasites from the body. Guidelines of National Institute of Malarial Research (NIMR) too recommends combination therapy for P. falciparum. Arterolane maleate, a rapidly acting drug in combination with long-acting piperaquine phosphate is an anti-malarial product in line with WHO-recommended combination therapy for the treatment of uncomplicated P. falciparum malaria. Though insecticide and spraying materials and insecticide-treated nets are other possible solutions to control malaria, they have not been very successful in India so far. Trends of Malaria in India Year Total malaria cases (million) P. falciparum cases (million) Cases of P. falciparum (%) 2008 1.53 0.77 50.81 2009 1.56 0.84 53.72 2010 1.49 0.77 52.12 PL Joshi, faculty, National Institute for Health and Family Welfare (NIHFW), New Delhi, points out that apart from having the support of external agencies, developing nations must have its own redressal mechanism in place. Appreciating the funding from the World Bank and technical guidance from WHO, he says unless a proper preventive mechanism is enforced, it would be difficult to tackle the menace. â€œThe Government of India has stepped up its efforts. This is clearly visible from the change in the drug policy. There are various programmes educating people about the preventive measures. In place of small projects a decade ago, there are currently projects worth 500-600 crore focusing on malarial research,â€? he adds. Fresh hopes The success of phase III trials of GlaxoSmithKline vaccine, which the company has been developing with Path malaria vaccine initiative, has raised hopes for an anti-malarial vaccine. GSK has already invested 1,500 crore ($300 million) in the project and will invest further 250 crore ($50 million) to 500 crore ($100 million) in it. In India, Ranbaxy has developed Arterolane maleate, a rapidly acting drug in combination with long-acting piperaquine phosphate. It has also developed a new chemical entity, Arterolane, in combination with piperaquine, which is expected to have superior benefits over the currently available anti-malarial therapies. The new drug is a once-a-day therapy for three days. Research done by Virander Chauhan and Chetan Chitnis at the ICGEB has led to the development of a first generation vaccine, MJAIVAC1, which is based on combination of two merozoite antigens (MSP-119 and EBA-175). The vaccine is presently being tested for safety and immunogenicity in a phase I clinical trial, the first for a malaria vaccine developed in India. The ICGEB has also developed a portfolio of novel antigens that is currently at different stages of preclinical development. Also, the center has developed a vaccine, PvDBPII, for Plasmodium vivax which is being produced by a biotechnology company for a phase I clinical trial. Under a government-funded project, Mumbai-based IPCA Labs, along with Jamia Hamdard University, New Delhi, has developed a genetically modified variety of Artemisinin Annua that can generate high yield of artemisinin. Once approved, the variety will be put to confined-field trials for evaluation and then patented and commercialized for cultivation by farmers. The group expects that this variety will fetch more than one percent artemisinin in field trials. Rahul Koul in New Delhi ]]> <![CDATA[Clear regulatory pathway for diagnostics kits]]> https://biospectrumindia.com/news/95/4480/clear-regulatory-pathway-for-diagnostics-kits.html https://biospectrumindia.com/news/95/4480/clear-regulatory-pathway-for-diagnostics-kits.html Fri, 11 May 2012 15:02:00 +0530 Despite increasing emphasis on strengthening infrastructure for healthcare, the Indian government has overlooked the need to chalk out a well defined regulatory pathway for diagnostic products, leaving many domestic companies lurching in the dark Ayear back, a couple of days after the Indian Finance Minister presented the budget, a renowned expert from the diagnostic sector shared his disappointment with BioSpectrum about the budget failing to address the sector's needs. He said, â€œWe have been a neglected sector. We are yet to have a separate set of regulatory guidelines for this sector.â€? One year hence, the situation hasn't changed. Indian diagnostic industry comprises of biochemical testing, hematology, microbiology, immunology, coagulation, urinalysis, critical care, and molecular diagnostics. The Indian diagnostics market witnessed a growth of 22 percent from 2,000 crore to 2,440 crore in 2010-11. Despite the prime significance of this sector, a well-defined regulatory pathway for diagnostic products is awaited. Due to the lack of a regulatory legislation there is no clarity on the classification and requirements for approval of diagnostic products and novel medical devices in India. Need for a change Experts from the diagnostic sector are now clamoring for a change in the way approvals to such products are given by the drug controller general of India (DCGI). At the time of approval, diagnostic products and medical devices are categorized into critical and non-critical diagnostics. Any diagnostic tool developed by an indigenous company or academic institution has to go through a validation process conducted by an independent, DCGI approved testing lab such as National Institute of Biologicals (NIB), apart from the in-house validation procedures conducted by the company itself. For other products, it needs to be proven that there are same products approved in India. Despite the huge technological differences between the two, diagnostics are still treated as drugs by the DCGI. Shama Bhat, chairman and managing director, Bhat Biotech, says, â€œIf it is a new product then you need to get a no objection certificate (NOC) from the DCGI. The major hurdles are the lack of knowledge of the products by the DCGI. Most of the officers are pharma people and they lack the knowledge of diagnostics.â€? Today, the DCGI recognizes primarily HIV, Hepatitis B and C blood grouping, and Syphilis kits as the ones needing serious licensing and regulation. BV Ravi Kumar, founder, chairman and managing director, Xcyton Diagnostics, says, â€œRegarding the rest of kits, there are neither guidelines nor any institutes, with known positives and negatives to be tested. As a result, the Indian companies innovating new diagnostics have a great difficulty in catering to overseas market opportunities as the country of origin has no well laid out procedures.â€? Dilip G Tripathi, managing director, Tulip Diagnostics, agrees with Kumar and says, â€œToday there is no clear definition of what can be defined as critical and non-critical diagnostic products. So every time we go to the DCGI for an approval of our product, it is randomly given a critical or a non-critical status without giving any clear reason for their classification.â€? Obscurities also lie in the validation processes. Satish Gupta, deputy director, National Institute of Immunology, says, â€œI agree that an independent validation is an important process as an in-house team can sometimes be biased. However, there is no clear pathway by the government on what and how exactly should the validation process be carried out. The DCGI has not assigned a team for the task. Companies have to scout around for institutes or hospitals to test and validate their tools. This leads to undue delays in bringing the product to the market.â€? On the contrary, products which are imported and marketed into the country do not have to go through these procedures because they have been approved by globally accepted regulatory standards. Indian companies beg to differ as they claim that given India's diverse population, validation becomes a prerequisite for all companies. Pradip K Desai, founder chairman and director, Span Diagnostics, mentions, â€œValidation, indigenous or imported, is very important because it may so happen that it might be effective on one section of the population while it may not be effective on the other due to India's large genetic diversity. Government needs to establish a clear pathway for such evaluation processes.â€? The quality of the testing labs is also questionable. Ravi Kumar adds, â€œThese are academic institutes not geared to conduct these kinds of evaluations on a regular basis, and hence their validation processes cause unusual delays. This also vitiates the results due to institutes' bias of what?the specifications of the test should be than what the market requirement is.â€? For instance, kits recently tested at NIB for quality assessment were pulled up by the DCGI on grounds of quality. Kumar informs, â€œDue to serious deficiencies in the procedures many companies suffered, as some batches got unfairly labeled as 'not meeting specifications'. Now, National Aids Control Organization (NACO) has finally commissioned many institutes across India such as National AIDS Research Institute (NARI), National Institute of Mental Health and Neuro Sciences (NIMHANS) to conduct quality evaluations for the batches.â€? The lack of clear specifications also allows for many products, which are not classified by the DCGI, to get into the market without any approval. Says a source on the condition of anonymity, â€œMany a times new products cannot be introduced to market as they don't fit in any regulatory classification. Thus, lack of such a regulatory framework and standards in India brings a large disparity on the quality of products. Many products are available in India without approval.â€? Sandeep Saxena, founder CEO, Acton Biotech, mentions, â€œThis puts pressure on the buyer to first test the product in-house before using it on patients. And in turn the buyer expects free samples from the seller. That delays the sales cycles and increases costs.â€? Separate regulatory authority A recent hurdle which is being faced by segments across the biotech sector is the frequent changes of the DCGI. â€œIn the last couple of months, two DCGIs have been changed who were there for a temporary period of time. This has led to a lot of our approvals getting delayed because by the time we submitted our approvals to one DCGI, it was time for him to move on and we had to repeat the whole process from the start when the new person came,â€? adds Tripathi. Speaking to BioSpectrum, most of the industry experts from the top indigenous companies demand that there should be a separate regulatory authority for approving diagnostic products where specific dossiers can be submitted. Saxena says, â€œIt is high time DCGI looked beyond drugs. They need separate teams for vaccines, devices, and diagnostics.â€? Many domestic companies have also said that there is a dire need for a central testing lab for diagnostic products which can come about only when there is a clear well-defined pathway for the sector. The Association of Diagnostic Manufacturers of India (ADMI), an association of Indian in vitro diagnostics manufacturers, has approached the government with various proposals for reforms , but it has not received any response so far. To bring about uniformity in classification and specifications among all diagnostic products, the association had made a list of above 100 products along with their respective classifications and specifications. Tripathi, who is also the president of the association, recalls, â€œWe had collected and collated a list of diagnostic products from all the companies in India along with their specifications and submitted to the DCGI for reference, but there was no result. It took us one year to collate such data but the entire effort was wasteâ€? India is at an inflection point today when it comes to innovation in diagnostics. Investments, both in terms of time and money, towards this sector by the Government of India will not just lead to a spurt in affordable new products , but also bolster the quality infrastructure in the country. Nayantara Som Banerjee in Mumbai ]]> <![CDATA[Efficient allocation of public funds for biomed R&D]]> https://biospectrumindia.com/news/95/2757/efficient-allocation-of-public-funds-for-biomed-rd.html https://biospectrumindia.com/news/95/2757/efficient-allocation-of-public-funds-for-biomed-rd.html Fri, 11 May 2012 14:57:00 +0530 Biosciences is one of the few industrial sectors in the world which is highly dependent on public funds for research which advances the frontiers of knowledge and leads to effective solutions. Most of the fundamental breakthroughs recorded in this segment in the last century have their origins in publicly-funded research institutions. In such a scenario, public policy makers always have to make the difficult choices related to allocation of resources to fund research to find cure against the long list of diseases that require urgent attention. They also have to weigh their options against short term and long term requirement of the society, as well as problems that affect the most number of people and also the neglected diseases. In a thought-provoking paper published in the latest issue of scientific journal PLoS ONE, three top American researchers have made a compelling case to follow the â€œfinancial portfolio theoryâ€? used by financial investors to maximize their returns. Using the same theory, the researchers argue that if health policy makers allocate the limited available resources to research projects that extend human life as the most important criteria, the returns for public investments will be maximum. The three authors of the paper-Dr Andrew Lo of the MIT Sloan School's Laboratory for Financial Engineering, Dr Dimitrios Bisias at the Massachusetts Institute of Technology (MIT) and surgeon James Watkins of Brigham and Women's Hospital in Boston--applied the theory to the annual $30 billion spent by the US National Institutes of Health (NIH) and predict that the financial theory based research allocation will increase the lives lost by 28 to 89 per cent in a year. What the researchers suggest is that the best results for public funds will be to concentrate on diseases that affect the most number of people so that more lives can be saved with the available resources. This scientific paper has already initiated a major debate among various stakeholders of the healthcare system. Vocal critics of the paper fear that if governments adopt such an allocation plan, many of the neglected diseases and some research work which may not have promise currently but could turn out to be potential breakthroughs could be affected immensely. India too is increasing public investments in the bioscience sector in a big way. Various national policies have outlined the resource allocation plans. After a wide national debate, the government has given a new lease of life to the public sector network of vaccine manufacturers. The revival plan of $120 million to improve facilities at the vaccine plants in Kasauli in Himachal Pradesh, Chennai and Coonoor in Tamil Nadu is the harbinger of a new era of public investments in an area where it is needed urgently to augment the efforts of the globally-acclaimed private vaccine manufacturers in the country. The cover story of this issue provides a comprehensive review of the life breathing efforts into the Indian public sector vaccine manufacturing industry. As public investments increase, the private sector has also upped the investment efforts. The inauguration of the $25 million Biocon Research Center in Bangalore on April 5, 2012 marks yet another milestone for this company. With this new facility, the Biocon Park in south Bangalore becomes the largest single campus for biotechnology researchers in Asia, housing over 3,000 scientists. Narayanan Suresh Chief Editor sureshn@cybermedia.co.in ]]> <![CDATA[Hope floats for vaccines against neglected diseases]]> https://biospectrumindia.com/news/95/1855/hope-floats-for-vaccines-against-neglected-diseases.html https://biospectrumindia.com/news/95/1855/hope-floats-for-vaccines-against-neglected-diseases.html Fri, 11 May 2012 14:54:00 +0530 Indian companies are leading the way in developing vaccines for neglected diseases such as kala azar and chikungunya. This emerging trend will have a profound impact on improving the lives of thousands of people in the developing world The first-of-its-kind clinical trial to test the efficacy of a novel visceral leishmaniasis vaccine is all set to start in India as a part of joint initiative by the Infectious Disease Research Institute (IDRI), a Seattle-based non-profit organization and Pune-based Gennova Biopharmaceuticals. This announcement comes close on the heels of Indian Immunologicals conducting preclinical studies for the world's first chikungunya vaccine. There are no vaccines for either of the diseases till now. Traditionally, falling under the ambit of â€œneglected tropical diseasesâ€?, cases of visceral leishmaniasis and chikungunya are found largely in developing countries. Due to low or no prevalence in developed countries, the market size for vaccines or drugs for these diseases is not considered to be highly profitable. In this light, the fact that Indian companies are now taking the initiative to develop solutions for such problems is a welcome move. According to World Health Organization (WHO), leishmaniasis, is found in 88 countries, with 1.6 million cases to occur worldwide. The most pathogenic form of this disease is visceral leishmaniasis, more commonly known as kala azar or black fever, a name derived from the darkening of face, hand, feet, and abdomen skin, which is a common occurrence in this disease. Since mandatory reporting is present in only 33 of the affected countries, only 600,000 cases of leishmaniasis are reported, of which 500,000 are that of visceral leishmaniasis. Over 90 percent of these cases occur in Bangladesh, Brazil, Ethiopia, India, Nepal, and Sudan causing 50,000 deaths every year, making it the second-largest parasitic killer in the world. If left untreated, kala azar has 90 percent chances of case fatality with death within two years. Kala azar is caused by a parasite of the genus Leishmania. The pathogenesis is very much like that of the malarial parasite where the pathogen spreads through the insect vector, a sandfly. The current treatment modalities involving amphotericin still remain expensive in developing countries such as India where Bihar, with a large population below the poverty line, is the worst affected state. Of late, kala azar has been in the news for patients showing coinfection with leishmania and HIV, an emerging problem that could escalate further. Dr Sanjay Singh, chief executive officer, Gennova Biopharmaceuticals, says, â€œThe kala azar vaccine is a joint effort of IDRI, which developed the vaccine, Gennova, which will produce the vaccine, and Banaras Hindu University Medical Institute that will conduct the phase I trials. The phase I trial, which has to be first conducted in the US for the highly purified, recombinant vaccine, has already started after which the Indian trials will be initiated.â€? He adds that if successful â€œwe hope to conduct the phase II trials soon, with support from the Department of Biotechnology. Being a parasitic disease, developing a vaccine for kala azar has been very tough, but our motivation for eradicating it is very strong. The vaccine would be produced at our recently inaugurated Vaccine Formulation and Research Centerâ€?. The phase I clinical trials are being funded by the Bill and Melinda Gates Foundation, which has made several efforts to bring diseases such as kala azar into the spotlight. Recently Bill Gates announced a five-year 1,900 crore ($363 million) commitment to support product operational research for neglected tropical diseases (NTDs) on behalf of the Foundation. Chikungunya is also a vector-borne viral disease that is transmitted through mosquitoes, and does not have any specific treatment. According to WHO, chikungunya occurs in Africa, Asia, and the Indian subcontinent, and several outbreaks have been reported in the recent past. The most recent one occurred in 2006 in India when several states, including Andaman and Nicobar islands, were affected. Over 74,000 cases were reported in Tamil Nadu and Odisha. KV Balasubramaniam, managing director, Indian Immunologicals (IIL), says, â€œCurrently, no vaccine is available for chikungunya in the world. Today, it is important to find innovative solutions to India-centric problems, and putting in efforts to prevent this important disease aligns well with the mission and vision of IIL.â€? Along the lines of the kala azar vaccine, IIL too joined hands with a US-based research organization for the development of the chikungunya vaccine. Ramesh Mathur, general manager, research and development, IIL, explains, â€œChikungunya virus vaccine that IIL is developing is a live attenuated virus vaccine. The virus strain was isolated from a patient and later converted into an attenuated vaccine strain. This vaccine strain was purified, shown not to cause chikungunya disease, and determined to be suitable as a vaccine strain.â€? He says that it may take 12-16 months to submit an application to the regulators for clinical studies. What makes the impact of the diseases such as chikungunya even more profound is the chronic disability caused in patients. â€œThe quality of life post recovery from infection in the case of chikungunya can deteriorate. The negative effect lasts for a few years in severe cases. In this situation, in a country such as India, if bread winners in the low income group get infected, it disrupts their normal life and creates a huge financial burden. Value of the vaccine to the society in general is high compared to just the vaccine price,â€? explains Mathur. With Indian vaccine companies having the capabilities to supply more than 50 percent of the world's requirement of vaccines, it would be an irony if diseases such as these remain unaddressed. Another factor needed for the successful elimination of these diseases is a concerted government effort to make vaccines available to the target population. Having acknowledged the problem, Bangladesh, India, and Nepal signed a memorandum of understanding in 2005 to eliminate visceral leishmaniasis by reducing the incidence of the disease to less than 1 case in 10,000 individuals by 2015. With only three years left for the deadline, vaccine initiatives need to be supported adequately by the Indian government for them to make a difference. Industry experts and government officials agree that the need of the hour is to find a â€œMade in Indiaâ€? solution to this problem. Other neglected diseases, such as sleeping sickness and dengue, too need a strong campaign for research and development to ensure their prevention and cure. The responsibility of such initiatives to find new treatment modalities falls upon those countries that carry the burden of the disease itself, that is the only hope for effective prevention of such diseases. Manasi Vaidya In Bangalore ]]> <![CDATA[Marken launches new branches]]> https://biospectrumindia.com/news/95/2906/marken-launches-new-branches.html https://biospectrumindia.com/news/95/2906/marken-launches-new-branches.html Thu, 12 Apr 2012 15:58:00 +0530 Marken continued its expansion of services in India by augmenting its existing Mumbai facility with four additional branches to support the growing demand in clinical trial logistics within India. The expansion in New Delhi, Hyderabad, Pune and Bangalore will support the growing need for temperature controlled logistics of sensitive drugs and cold chain specimens. Marken is currently developing a new purpose-built good manufacturing practice (GMP) compliant depot in Bangalore that is due to be completed by the end of 2012. The depot will join Marken's already operational Argentina, Mexico and Singapore depots, offering the full range of temperature controlled storage capabilities, including controlled, ambient, refrigerated and frozen as pharmaceuticals and medical devices. Ranbaxy's Atorvastatin now in Europe Ranbaxy Laboratories launched the generic versions of Atorvastatin tablets, 10 mg, 20 mg, 40 mg and 80 mg in Italy and Sweden; and 10 mg, 20 mg and 40 mg in the Netherlands, after receiving approval from the respective local regulatory authorities. In accordance with its settlement agreement with Pfizer, Ranbaxy introduced the product ahead of the applicable patent expiries. Pfizer's patent expires in Italy on May 8, 2012, and in the Netherlands and Sweden on May 6, 2012. Atorvastatin, which is a cholesterol reducing drug, is the largest selling pharmaceutical product in Italy with sales of 1885 crore ($377 million) (according to IMS MAT Dec, 2011). The market size for Atorvastatin in the Netherlands is 822 crore ($164.4 million) and in Sweden is 275 crore ($55 million), according to IMS MAT Dec, 2011. Health ministry to monitor TB cases Union Minister for Health and Family Welfare, Mr Ghulam Nabi Azad, highlighted the government's emphasis on early diagnosis and complete treatment of drug-sensitive tuberculosis (TB) cases under the Revised National Tuberculosis Control Programme (RNTCP) in order to prevent the emergence of drug-resistant TB. Mr Azad said that the 12 cases recently reported in Mumbai were all extensively drug-resistant TB (XDR-TB) cases. In the terminology of the Word Health Organization (WHO), the phrase 'totally drug-resistant tuberculosis (TDR-TB)' does not exist. A cumulative total of 6,994 drug-resistant TB cases have been put on treatment in the country under RNTCP. All states and union territories have introduced services with variable access across 260 districts in the country, with continuous monitoring of services by the ministry. The diagnosis and treatment protocols for all forms of drug-resistant TB, including XDR-TB, have been developed and disseminated in the country. As per the health ministry's figures, there are 37 accredited quality-assured culture and drug susceptibility testing laboratories to diagnose drug-resistant TB cases in the country. Dr Reddy's launch of Ziprasidone Dr Reddy's Laboratories recently launched Ziprasidone Hydrochloride capsules, a bioequivalent generic version of Geodon in the US market, following the approval by the US Food and Drug Administration. The Geodon brand had US sales of approximately $1.34 billion for the most recent 12 months ending December 2011, according to IMS Health. Dr Reddy's Ziprasidone Hydrochloride capsules, in 20 mg, 40 mg, 60 mg and 80 mg strengths, are available in 60 count bottle size. Center for climate research launched The International Crops Research Institute for the Semi-Arid Tropics (ICRISAT) and the Department of Science and Technology (DST-Climate Change Program), Ministry of Science and Technology, Government of India, launched the Center of Excellence on Climate Change Research for Plant Protection (CoE-CCRPP) at the ICRISAT headquarters near Hyderabad. The project, funded by the DST-Climate Change Program, is for a three-year period with an overall goal to establish facilities and provide opportunities for the ICRISAT and partner institutes to conduct research-for-development initiatives on climate change and its impact on diseases and pests on legumes in the semi-arid tropics. Dr Akhilesh Gupta, advisor, DST Climate Change Program (CCP) noted the merits of the CoE-CCRPP as being the only project among the 147 qualified projects under the program that received full support after a long and stringent process of approval. Abexome, Bioneeds collaborate Abexome Biosciences, an analytical solution provider to the biopharma industry, and Bioneeds, a leading OECD GLP certified pre-clinical service provider in India, are collaborating to provide pre-clinical and core biology services to pharmaceutical and biopharmaceutical companies in India using their complementary capabilities. Under this agreement, Abexome and Bioneeds will provide end-to-end solutions including custom antibody and ELISA method development, pharmacokinetic studies, regulatory toxicity studies and in vivo and in vitro efficacy assays for drug screening. Dr Vinay Babu, MD, Bioneeds, said that the collaboration will enable both organizations to access each other's complementary capabilities and offer a wider spectrum of services to pharma and biotech companies. Biogen's MS device gets DCGI nod Biogen Idec Biotech India received approval of the first, single-use, intramuscular autoinjector for interferon beta-1a, which are to be used by patients with multiple sclerosis (MS) in India. Approved by the Drug Controller General of India (DCGI), the new autoinjector, Avonex Pen, is designed to enable easier, more convenient interferon beta-1a administration, improving the treatment experience for MS patients. It was approved based on data from a specific clinical study supporting its effectiveness as a new treatment administration option. Biogen Idec recently received approval in the US and European Union for the autoinjector. Thousands of patients with MS in India are administered interferon beta-1a therapy. Once-weekly interferon beta-1a (intramuscular) is one of the most commonly prescribed treatments for the relapsing forms of MS worldwide. It has been shown to slow down the progress of physical disability and reduce relapses. It has been available for use in the US for more than 15 years and in India for the past five years. Panacea launches polio vaccine in Nigeria Panacea Biotec launched Polprotec, an enhanced potency, inactivated poliovirus vaccine, in Nigeria in collaboration with Emzor Pharma, Nigeria. On this occasion, Panacea Biotec and Emzor announced a joint 'Planet Polio-Free Mission' statement. The two firms pledged to contribute towards achieving the goal of global polio eradication. They also pledged that no child will ever again be paralyzed by the wild polio virus (WPV) or vaccine-derived polio virus (VDPV) by providing complete portfolio of oral polio vaccines (OPV) and inactivated polio vaccine (IPV) and IPV-based combination vaccine at an affordable price. Dr Dorothy Esangbedo, president, Pediatric Association of Nigeria (PAN), pointed out that this was the first time IPV was launched in Nigeria. Sun to supply Lipidox to the US The US FDA allowed the import of Lipodox, which will be supplied by Sun Pharmaceuticals, as a part of a series of steps to increase the supply of critically needed cancer drugs. This move is in response to the critical shortage of the cancer drug Doxil (doxorubicin hydrochloride liposome injection), which is used in multiple treatment regimens. Lipodox (doxorubicin hydrochloride liposome injection) will be temporarily imported as a replacement drug for Doxil. This drug is expected to end the shortage and fully meet patient needs in the coming weeks. The FDA's exercise of enforcement discretion for Lipodox is a temporary, limited arrangement specific to Sun Pharma Global FZE and its authorized distributor Caraco Pharmaceutical Laboratories. Swedish firm ties up with Cadila Bactiguard, a Swedish company offering solutions for preventing hospital acquired infections, signed an exclusive cooperation agreement with Cadila Pharmaceuticals. Under the agreement, Cadila Pharmaceuticals will sell the entire line of Bactiguard´s products throughout India. Dr Rajiv I Modi, managing director, Cadila Pharmaceuticals, explained why Cadila has chosen to work with Bactiguard. He said that hospital-acquired infections are a big problem for patients in India and Bactiguard has a unique solution targeted at preventing healthcare associated infections. He said that he was confident that hospitals in the country will embrace Bactiguard's clinically proven solution in order to help save lives in India. ]]> <![CDATA[Scotland woos biotech companies]]> https://biospectrumindia.com/news/95/1737/scotland-woos-biotech-companies.html https://biospectrumindia.com/news/95/1737/scotland-woos-biotech-companies.html Thu, 12 Apr 2012 15:42:00 +0530 Life sciences has been chosen as one of the sectors that the autonomous Scottish government of Mr Alex Salmond is giving special attention to. Scotland is a small country of less than six million people, situated north of England and is part of the United Kingdom. The political leadership of Scotland is sold on life sciences. Ms Nicola Sturgeon, deputy first minister and the cabinet minister for health and well-being, co-chairs the Scotland Life Sciences Advisory Board. Under the power devolution formula devised by the UK, Scotland has its own Parliament and government, and is run by the first minister (equivalent to a Prime Minister) and the deputy first minister along with a cabinet. Mr Andrew Henderson of Scottish Enterprises explains, â€œScotland has 640 organizations in this field, employs 32,000 people and generates more than Rs20,000 crore ($4 billion) in annual revenues and the industry has been growing at six percent per annum since 1998.â€? Furthermore, Scotland is one of the world's top five destinations for clinical trials. An ambitious strategy to double Scotland's life sciences output to 40,000 crore ($8 billion) by 2020 was unveiled in 2005. Some of the identified sectors for growth include stem cells and regenerative medicine, contract manufacturing, clinical trials, medical devices, cancer and cardiovascular diseases. â€œScotland has been a hotbed for innovations for centuries. We want to build on it and make it one of the choicest international destinations for innovation, collaboration, manufacturing and services in life sciences and also as a gateway to Europe,â€? says Ms Anne MacColl, CEO, Scottish Development International, during a recent interaction. Piramal to make cancer drug in Scotland It started in 1919 as the manufacturing site for chemical dye, Indanthrene Yellow G, the first one outside Germany. The original chemical plant of Scottish Dyes, situated in a small village Grangemouth, midway between Edinburgh and Glasgow, is a now a swank new facility of India's Piramal Healthcare. Piramal Healthcare inherited the facility through the acquisition of ICI Chemicals and on March 26, 2012, the site started commercial production of antibody drug conjugate (ADC), also called the 'smart bomb' since these molecules are used in a new range of anti-cancer drugs that hunt and destroy cancerous cells in patients. â€œThe drug got approval from the US FDA recently and will soon be available in Scotland too, after receiving European regulatory approval,â€? the facility's engineering manager, Mr Ian McLean, told BioSpectrum in March during a visit to the manufacturing unit. The Grangemouth facility is one of Piramal Healthcare's eight manufacturing units around the world and is one of the world's first such unit to make ADCs commercially on contract. Piramal works with 11 of the 16 global users of ADCs. Piramal has invested nearly 15 crore ($3 million) to upgrade the facilities with quality control labs and new manufacturing suites in recent years. The company received significant assistance from Scottish Enterprise, the Scottish government agency that supports businesses in Scotland. â€œThe expansion of Piramal's Grangemouth facilities is further evidence of Scotland's growing reputation as the ideal place to locate and do business. Investment like this provides new jobs and delivers new business opportunities and supply chain development across the local economy and throughout Scotland,â€? said Ms Linda Hanna, company growth director, Scottish Enterprise. High quality human resources coming out of 16 universities, five of which are ranked among the top five in the world's best 200 educational institutions, is one of the major strengths of the country. Physical infrastructure and industry-friendly government policies are an added attraction. The three major life sciences clusters, Glasgow, Edinburgh and Dundee, are separated by 60 km each and have excellent road and rail connectivity for quick movements. Edinburgh BioQuarter A new 100-acre facility, called the Edinburgh BioQuarter, is coming up in south Edinburgh, adjacent to the Royal Infirmary (a 1000-bed teaching medical hospital), to provide an integrated infrastructure for life science companies. BioQuarter is being built by US-based, Alexandria. One of the major occupants is the new 450 crore ($90 million) Scottish Center for Regenerative Medicine (SCRM), which has modern research, manufacturing and commercialization facilities and houses 220 researchers. It is Europe's largest stem cell research center, said Mr Mike Capaldi, commercialization director of Edinburgh BioQuarter. The BioQuarter has built up space in excess of two million square feet and the 6,000 crore ($1.2 billion) facility has been built through the public-private partnership model. Companies that locate here will have ready access to the 1,150 researchers at the nearby University of Edinburgh Medical School, a 170 crore ($34 million) bioincubator and the patients at the Royal Infirmary for clinical research. The Roslyn Institute, where Dolly, the world's first cloned sheep was born, is also located nearby. Stem cells leader Just outside Edinburgh, located in the Pentlands Science Park, is a unique company called Angel Biotech. This publicly listed biotech firm is a leading contract manufacturer of stems cells that are used in a variety of new regenerative therapies. â€œOur mammalian cell culture team has extensive experience in cell line selection, cloning, cell banking and process scale-up with xenogeneic, allogeneic and autologous primary human stem cells and other stem cell therapies,â€? said Angel Biotech's acting CEO, Dr Stewart White. Angel has been at the forefront of developing new stem cells therapies developed in research labs into products for commercialization. Angel provides small scale manufacturing facility and test the strengths of these lines developed in laboratories. It is also a major contract manufacturer of recombinant proteins, antibody and bacteriophages. With many more such advanced facilities, Scotland has embarked on a high decibel campaign to make the world sit up and take notice of its expertise in life sciences. Scottish Development International, the agency tasked with this project, has been meeting life science companies in India in recent weeks. The emphasis here to drive the message that the Scotland Government will do everything in its power to boost its business friendly policies. No wonder that although it is a relatively small country, it already has more than 2,000 foreign companies that have significant presence. Innovation is in the country's gene. The list of original inventions from Scotland is very long and includes Sir James Young Simpson, who was the first person to introduce chloroform in anesthesia in 1847; Dr John Macleod, a Scottish scientist who co-discovered insulin in 1923; invention of hypodermic syringe by Dr Alexander Wood in 1853; pioneering ultrasound scan by Dr Ian Donald in 1950s; the discovery of beta-blockers by Dr James Black and development of Zantac and Ventolin by Sir David Jack in 1980s. Now Scotland is preparing for the next wave of innovation. Narayanan Suresh in Edinburgh (The writer was in Scotland at the invitation of Scottish Development International) ]]> <![CDATA[US-India life science summit in May]]> https://biospectrumindia.com/news/95/1724/us-india-life-science-summit-in-may.html https://biospectrumindia.com/news/95/1724/us-india-life-science-summit-in-may.html Thu, 12 Apr 2012 13:42:00 +0530 The USA-India Chamber of Commerce (USAIC), a bilateral chamber of commerce, will organize its annual US-India BioPharma & Healthcare Summit on May 11, 2012, at the Hyatt Cambridge, Massachusetts, USA. The summit will focus on overcoming the barriers in building collaborative partnerships between the Indian and global companies. Panel discussions and keynotes will cover Drug Discovery & Development, Emerging Markets, Licensing, Industry-Academic Partnerships, Clinical Research, Funding Innovation and Cross Border M&A trends. There will be a specific high powered panel discussion on oncology deliberating the science, research trends and investor perspective. Exclusive invitation-only strategy sessions will focus on industry-academia partnerships, co-chaired by Noble Laureate Philip Sharp of MIT, and Dr Sridaran Natesan of Sanofi. External R&D strategies session will be co-chaired by Dr Rick Connell of Pfizer, Dr Sandeep Gupta of Endo Pharma and Sri Mosur of Jubilant Life Sciences. Dr Elias Zerhouni, president Global R&D, Sanofi; Dr John Leonard, senior vice president R&D, Abbott; Dr Bill Hait, head of R&D, Johnson & Johnson Pharma; Dr Ivan Gergel, executive vice president, R&D, Endo Pharma; Dr Michael Rosenblatt, executive vice president & CMO, Merck; Dr George Scangos, CEO, Biogen Idec; Dr Roger Glass, director, Fogarty International Center (NIH); and Dr Peter Mueller, global head of R&D, Vertex Pharmaceuticals, will participate in the event. The agenda for 2012 summit is a result of post summit strategy session held in Delhi in November 2011. The brainstorming session was attended by over 40 prominent CEOs, secretary biotechnology, secretary S&T, the DCGI and several joint secretaries. USA-India Chamber of Commerce has an advisory board of key global R&D leaders, academicians and venture capitalists who are passionate about innovation in biopharma and healthcare. Annual R&D budget of the board members is more than $25 billion. ]]> <![CDATA[Industry discusses healthcare diagnostics]]> https://biospectrumindia.com/news/95/2558/industry-discusses-healthcare-diagnostics.html https://biospectrumindia.com/news/95/2558/industry-discusses-healthcare-diagnostics.html Thu, 12 Apr 2012 13:40:00 +0530 Experts deliberate on developing affordable diagnostic tools and need for clearer regulatory pathways at an event held in Mumbai LThe conference on 'Technological challenges in developing affordable in vitro molecular diagnostics', organized by Yashraj Research Foundation and Mahatma Gandhi Mission (MGM) in Mumbai, brought together renowned scientists on one platform. Discussions at the event revolved around technological advances made in developing more sensitive, specific and predictive methods for healthcare diagnosis. They also discussed how these methods can be made more affordable for the poor. Interesting topics of discussion, included crossroads and technology options in in vitro diagnostics; true faces of biomarker discovery; opportunities and challenges in developing and implementing diagnostics in low-resource settings; new platforms in cancer diagnostics; low cost point-of-care tests for infectious diseases and challenges in affordable multiplexed diagnostics. Industry experts also said there was an urgent need for a clear regulatory pathway for approval of diagnostic tool products. They sought a change in the way approvals of such products are given by the DCGI. Furthermore, any indigenous diagnostic tool developed by an indigenous company or academic institution has to go through a validation process conducted by an independent team (this is apart from the in-house validation procedures conducted by the company itself), the guidelines for which again are not clearly defined. Experts also opined that there should be a separate window for diagnostic tools' approval within the DCGI. Nayantara Som Banerjee in Mumbai ]]> <![CDATA[The night of honor]]> https://biospectrumindia.com/news/95/4468/the-night-of-honor.html https://biospectrumindia.com/news/95/4468/the-night-of-honor.html Thu, 12 Apr 2012 13:39:00 +0530 4th BioSpectrum Asia Pacific Bioscience Industry Awards@Singapore Life sciences industry leaders from Asia Pacific gathered for a glittering ceremony in Singapore to celebrate the success of companies in the region at the 4th BioSpectrum Awards Nite on March 16, 2012. Dr Benjamin Seet, executive director, Biomedical Research Council, Agency for Science Technology and Research (A*STAR), Singapore, was the guest of honor. The 12 winners under the different categories were applauded by over hundred delegates from across Asia. Mr Abraham Mathew, group editor, BioSpectrum, set the tone for the evening by highlighting the fact that the world has realized that the next generation medical products will need Asian inputs to become successful. So, they are flocking to set up their research facilities, do a large part of their drug discovery work and conduct clinical trials in a big way to speed up the drug development process, he pointed out. â€œBioSpectrum Awards is an extension to observe and highlight the winners in the long battle to tackle the world's emerging health problems and find solutions. Through these awards, BioSpectrum is playing the role of picking tomorrow's winners, nudging today's entrepreneurs to achieve greater glory and honoring yesterday's key players who laid the foundation for success,â€? Mr Mathew noted. Dr Seet appreciated the Asian companies for their commendable performance and achievements and noted that Asia is hub for potential growth and innovation. Addressing the audience, he remarked that the way Singapore has developed itself into a highly advanced biotech hub, Asian companies can take advantage and grow and thrive in the forthcoming opportunities. â€œWhat Asian companies have to consider is to maintain consistency in their growth besides the challenges posed by western economy,â€? he said. The most prestigious award of the year, BioSpectrum Lifetime Achievement Award 2012 was conferred on Dr John Ballard, co-founder and director of BioAngels, Australia. The international jury unanimously chose Dr Ballard who, in a career spanning four decades, has successfully played many different roles and contributed to building the industry in Australia from scratch. Dr Ballard, who could not travel to Singapore due to health issues, thanked BioSpectrum and the jury for acknowledging his long stint in life science industry through an email response. Emerging company of the year winner, TaiMed Biologics, too could not make it to the event in Singapore to receive the award. Ms Nandita Singh, editor, BioSpectrum, concluded the grand and glamorous evening thanking the jury members and the audience for making the awards a success. Pictures from the ceremony var imgarray= new Array(); var loadarray= new Array(); imgarray[0]="http://biospectrumindia.ciol.com/images/content/2012/apr/1.png"; imgarray[1]="http://biospectrumindia.ciol.com/images/content/2012/apr/2.png"; imgarray[2]="http://biospectrumindia.ciol.com/images/content/2012/apr/3.png"; imgarray[3]="http://biospectrumindia.ciol.com/images/content/2012/apr/4.png"; imgarray[4]="http://biospectrumindia.ciol.com/images/content/2012/apr/5.png"; imgarray[5]="http://biospectrumindia.ciol.com/images/content/2012/apr/6.png"; imgarray[6]="http://biospectrumindia.ciol.com/images/content/2012/apr/7.png"; imgarray[7]="http://biospectrumindia.ciol.com/images/content/2012/apr/8.png"; imgarray[8]="http://biospectrumindia.ciol.com/images/content/2012/apr/9.png"; imgarray[9]="http://biospectrumindia.ciol.com/images/content/2012/apr/10.png"; imgarray[10]="http://biospectrumindia.ciol.com/images/content/2012/apr/11.png"; Prev Next var slide; document.onload=setting(); function setting() { slide=document.getElementById('pic'); slide.src=imgarray[0]; } /*create image space in mem*/ for (var j=0; j ]]> <![CDATA[Fostering collaboration]]> https://biospectrumindia.com/news/95/1360/fostering-collaboration.html https://biospectrumindia.com/news/95/1360/fostering-collaboration.html Thu, 12 Apr 2012 13:31:00 +0530 2nd BioSpectrum Asia Pacific BioScience Forum The second edition of BioSpectrum Asia Pacific BioSciences Forum, held in Singapore on March 16, 2012, brought together key members of the biosciences industry in APAC, including researchers, entrepreneurs, investors and government representatives and gave them an opportunity to share their views on the platform. The theme was â€œFostering Collaborations in Asia BioSciences Industryâ€?. This was the second year when BioSpectrum Asia successfully organized a neutral forum for Asian leaders of the industry. BioSpectrum Group Editor Mr Abraham Mathew gave the keynote address. He spoke about how unlike the pharmaceutical market of North America and Western Europe, the emerging markets of Asia are characterized by diverse therapeutic segments, different and complex regulatory laws and a fragmented market. He noted that according to Frost & Sullivan, the Asia Pacific healthcare market in 2011 was estimated to make up 28.5 percent of the global healthcare market and will grow to 34.6 percent by 2015. â€œWe could claim a shift in power in the pharmaceutical markets of the world, away from the major developed powers of the US, Canada, Western Europe and Japan, to a set of new, dynamic and fast-growing emerging economies of China, Brazil, India, Mexico, Russia, South East Asia, South Korea and Turkey. This will create a new set of dynamics,â€? said Mr Mathew. The forum saw participation of eminent industry leaders from the Asia Pacific region, such Ms Cheryl McCaffery, deputy director, A*Star, who shared her thoughts on â€œCollaborations and factors to help ensure success to Asian companiesâ€?. â€œIn order to reduce development time of technology or assays and to look for possible leads, MNCs are seeking collaboration in emerging market. Industry partners facilitate knowledge exchange between scientists in research organization and help researchers learn to apply their technology in the real industry,â€? she said. Mr Victor Skladnev, CEO, AIMEDICS, Australia, shared the success story of their product HypoMon and its journey from a university spinout to a successful commercial product. Mr Peeyush Jain, deputy managing director, Venus Remedies, India, showcased the way innovation has driven the company to attain global footprints. Mr Joshua Funder, director, Spinifex Pharmaceuticals, Australia; Mr Matthijs van Leeuwen, co-founder & COO, Simugen, Malaysia; Dr Noel Moore, CEO, HistoIndex, Singapore; and Mr Mallikarjun Sundaram, CEO, Mitra Biotech, India, participated in a panel discussion on 'Fostering Asia-Asia collaboration'. Dr Funder moderated the discussion and said venture capitalists can play a key role in improving collaborations in Asia. Dr Moore added that one of the challenges that young companies face is ensuring return of investment at the starting days. Collaboration at an initial stage not only helps to cut cost but also to share the risk, he pointed out. Mr Leeuwen added that the governments, pharmaceutical companies and biotechnology companies can play an instrumental role in providing development path to young companies. Mr Sundaram said companies should look at bringing in innovation in their product, so that the chances of establishing potential partnership and eventually bringing profitability increase. Dr Wilber Huang, president and CEO of Abnova, Taiwan, and Dr BG Rhee, president, Green Cross, South Korea, showcased their successful stories of building core competencies that allowed them to give tough competition to global players. Dr Jane Tsai, deputy director general, Industrial Technology Research Institute, Taiwan, talked about the opportunities in Taiwan and the window it opens for the giant China market. Amrita Tejasvi in Singapore ]]> <![CDATA[After Bt cotton]]> https://biospectrumindia.com/news/95/2434/after-bt-cotton.html https://biospectrumindia.com/news/95/2434/after-bt-cotton.html Tue, 10 Apr 2012 16:31:00 +0530 The benefits of Bt cotton have been realized. It is time to introduce other technologies to maintain the boom in cotton cultivation IMaharashtra, over the past one year, has seen a drop in yield and production of Bt cotton, especially in the dry regions of Vidarbha that receives low rainfall. This is despite the fact that today 95 percent of the total land sown in the state comes under Bt cotton cultivation. According to statistics provided by the Maharashtra Cotton Growers Marketing Federation Limited, the total sown area in Maharashtra between 2011-12 was 41.26 lakh hectare. Out of this, the total area sown under Bt cotton was 39.20 lakh hectares in 2011-12 as compared to 36.21 lakh hectare in 2010-11. However, the production saw a drop to 69 lakh bales in 2011-12 as compared to 74.73 lakh bales in 2010-11. Productivity saw a drop too with 2011-12 hitting a figure of 286 lint kg per hectare as compared to 322 lint kg per hectare in 2010-11. Maharashtra grows 35 percent of India's total Bt cotton. The area under Bt cotton cultivation is much more but industry experts opine that more needs to be done by the government to bolster yield and incentivize farmers. Dr NP Hirani, chairman of Maharashtra Cotton Growers Marketing Federation Limited, says, â€œLow irrigation facilities in the state has been a big problem for farmers. If you draw a comparative picture with other cotton-growing states, such as Gujarat, Andhra Pradesh, Punjab and Haryana, Maharashtra has the lowest area under irrigation. We have 15 percent of the cultivated area under irrigation, out of which four percent is surface irrigation and 12 percent is well irrigation. In Gujarat, irrigation comes up to around 40 percent, while in Punjab and Haryana, it is 99 per cent. In Andhra Pradesh, it is 39 percent.â€? To take Bt cotton to its next level of growth, irrigation and tools for water availability will play a crucial role in the coming months. Dr Gyanendra Shukla, director, Mahyco Monsanto Biotech (MMB), says, â€œOn the whole, India faces a water scarcity. In such a situation, the government, rather than giving monetary packages, should be thinking of providing such technologies as to how a farmer can store water and use them for his crops.â€? Against this backdrop, companies are already working on drought-resistant seeds. States like Gujarat and Rajasthan have been heavily investing in irrigation technologies over the past 10 years, with Gujarat reporting an impressive yield and acceptance from farmers. Dr BR Shah, director, Agriculture and Co-operation Department, Government of Gujarat, says, â€œThere is a very good response to Bt cotton from farmers. After introduction of Bt cotton, the area under Bt cotton has increased, while area under other crops has shown decreasing trend. There was a continuous rise in acceptability of Bt cotton in Gujarat.â€? The total area in Gujarat under Bt cotton cultivation is 24.62 lakh hectares out of 29.62 lakh hectares of total area under cotton in kharif 2011. Also, nearly 52.89 lakh packets of seeds of Bt cotton were sold in Gujarat during 2011-12. Also, cost of cultivation is taking a toll on farmers. Labor is scarce. The cost of cultivation for a farmer ranges between 15,000 and 20,000 per acre. This excludes land rentals. Labor for picking and weeding takes 60 percent of the cultivation cost. â€œThe seed packet prices might have gone up but that consitutes just seven-to-eight percent of the total cultivation cost,â€? says Dr Shukla. Bringing in technologies that can control both sucking pest and weeding can significantly reduce cultivation costs. Need of the hour Improved technologies to increase yields: It is time now to move on and bring in other improved technologies such as sucking pest tolerance technology; drought resistance technologies; saline tolerance technologies; and weed management technologies. Bring down cost of cultivation: Cost of cultivation constitutes a major portion of a farmers' cost. This includes cost of labor for picking of cotton, weeding and cost of seeds. Introduction of new technologies can drastically bring down costs while increasing yields. Improve irrigation facilities: Cotton in India is largely a rain-fed crop. The government should look at providing irrigation facilities or water storage facilities Incentivize research: Prices of seeds should be fixed in such a way that seed companies are incentivized to invest in more research on new technologies, while not burdening the farmers. Attractive procurement prices: The current low market prices of cotton could result in farmers shifting to other crops that generate better returns. The government needs to increase the price from its current level if Bt cotton is here to stay. No change in policies in the middle of the year: Import or export policies on cotton should be announced in the beginning of the season, so farmers can take the right decision before sowing. Market price is a hurdle Industry experts are unanimous in the view that though the increase in the price of Bt cotton seeds has not had any impact on the yield, the price or returns they get from the market will affect it. Fluctuations of cotton prices in the international market over the last one year has greatly affected the prices procured by Indian farmers. â€œThe price hike in Bt cotton seeds have not shown any adverse effect on cotton cultivation in Gujarat, but the fluctuating market price of during last two cotton trading season may affect cultivation of Bt cotton in the next kharif season,â€? says Dr Shah. According to industry experts, farmers may shift to other crops if there is no certainty on returns from Bt cotton. â€œIf cotton prices go up by 20 percent then we can see the area under Bt cotton cultivation to remain the same, but if it continues to remain in the current level, then we will see a shift to other crops, such as soybean or maize,â€? informs Dr Shukla. The government should constitute a policy regime where it can maintain a fine balance between commodity price for cotton and price that farmers procure in the market. New technologies can make a difference. The benefits of Bt cotton have been realized and it is time to move to the next level. â€œThe country has procured all the benefits of Bt cotton. Whatever improvement has to happen has taken place. It is time that we move to other technologies, which will improve yields. For example, sucking pest or drought-resistant technologies that many companies are working upon,â€? says Mr Dhiren N Sheth, president, Cotton Association of India, while adding â€œall stakeholders should come out with a consensual solutionâ€?. Nayantara Som Banerjee in Mumbai ]]> <![CDATA[From importer to exporter]]> https://biospectrumindia.com/news/95/5453/from-importer-to-exporter.html https://biospectrumindia.com/news/95/5453/from-importer-to-exporter.html Tue, 10 Apr 2012 16:26:00 +0530 With over 300 varieties of seeds to choose from, excess produce of Bt cotton has transformed India into an exporter of cotton India accounts for about 32 percent of the global cotton cultivation area and contributes 21 percent to the global cotton produce, second highest after China. Cotton production in India also has a wide impact on the livelihood of the farmers and on the economy of the country, apart from international trade. It provides employment to around 42 million people directly or indirectly. Globally, India ranks first in terms of cultivated area followed by China, the US and Pakistan. India more than doubled its production from 13.6 million bales in 2002 to 35.5 million bales in 2011. Over the past few years, India has even managed to produce at least six-to-nine million bales more than is required for domestic consumption. From a meager 308 kg per hectare in 2001-02, the average yield of cotton increased to 526 kg per hectare in 2008-09 and stayed above 500 kg per hectare in 2010-11 as well. Statistics show that the leap has much to do with the increasing popularity of Bt cotton in the 10 cotton-growing states of the country. This boom in cotton production has also transformed India from being an importer of cotton to a net exporter of the same. Exports have seen a tremendous rise from a mere 0.05 million bales in 2001-02 to 8.8 million bales in 2007-08. 2009: A landmark year In 2009, there were three notable developments in Bt cotton. First, the trend of adopting multiple gene (mostly two genes) Bt cotton, over single gene products, caught up in India. The first two-gene event MON15985 (Bollgard II) was developed by Mahyco and featured the two genes cry1Ac and cry2Ab sourced from Monsanto. That year, multiple gene Bt cotton occupied more hectares (57 percent) than single gene Bt cotton (43 percent). This was because multiple gene hybrids provide additional protection against Spodoptera (a leaf-eating caterpillar) and American bollworm, Pink bollworm and spotted bollworm. It has also been reported that multiple gene Bt cotton farmers earn higher profits through cost savings associated with fewer sprays of insecticides. The year 2009 also saw the first indigenous public sector Bt cotton, Bikaneri Nerma. Third was the approval to commercialize a new Bt cotton event that featured a synthetic cry1c gene developed by Metahelix Life Sciences. Last season, this second-generation Bt cotton seed was cultivated on 72 percent of the land under cotton cultivation, which is an increase by 371 percent in the last three years. A multipurpose crop An important but unrecognized fact about cotton is that, in India, roughly 67 percent of the cotton produced is used for animal feed, whereas the remaining 33 percent is used as fiber in the textile industry. It is cultivated in about 10 million hectares in the country. The main products of cotton plant are cotton lint and cotton seeds. Cotton lint is the fibre of the plant that is used in the textile industry. Cotton seeds yield three important by-products: linters, hulls and kernels. Linters are short fibres that are still attached to seeds after ginning. They are used for manufacturing products such as propellants used for gun ammunition. Hull of the cotton seed is used as animal feed. Oil extracted from the kernel is either used directly or is mixed with other edible oils for human consumption. Cotton is the only oilseed crop that has shown tremendous progress after the introduction of Bt cotton hybrids in 2002. The production of cotton oil registered a three-fold increase from 0.46 million ton in 2002-03 to 1.20 million ton in 2010-11. In 2009-10, cotton oil contributed about 13.7 percent of the total edible oil production in the country. The way forward The history of Bt cotton in India is a unique example of rapid technology acceptance. It even prompted Home Minister Mr P Chidambaram to urge scientists to replicate the success of Bt cotton in cereals and food crops. However, there is a need for good public awareness programs, a well-regulated seed distribution system and conducive market condition for the produce. Equally important is the cooperation among seed developers in public and private sectors, extension workers and scientific officers of companies in disseminating factual and reliable information about Bt products and their performance. Break-up of cotton by-products Item 2002-03 2009-10 2010-11 Cotton production (million bales) 13.6 29.5 32.5 Cottonseed production@310kg/bale (million tons) 4.21 9.15 10.07 Retained for sowing & direct consumption (million tons) 0.50 0.50 0.50 Marketable surplus (million tons) 3.71 8.65 9.57 Production of washed cottonseed oil (12.5% (million tons) 0.46 1.08 1.20 *very few farmers retain cotton seed for sowing over the last nine years, as cotton hybrid seed planting increased to 90% of cotton area. Cotton hybrid seeds production is undertaken seperately by specialized cotton growers and marketed by private seed sector in the country. Source: compiled by ISAAA, 2010; COOIT, 2010; AICOSCA, 2010) Vipul Murarka in Bangalore ]]> <![CDATA[Beyond the boom: 10 years of Bt cotton]]> https://biospectrumindia.com/news/95/1121/beyond-the-boom-10-years-of-bt-cotton.html https://biospectrumindia.com/news/95/1121/beyond-the-boom-10-years-of-bt-cotton.html Tue, 10 Apr 2012 16:24:00 +0530 What the government must do to push further growth? BioSpectrum traces the journey of Bt cotton in India and the impact it has had on the Indian economic scene. And also explores if this boom in cotton cultivation will continue Cotton farmers in India, who had once given up cotton cultivation due to unaffordable costs of production and expensive and ineffective pest control, have returned to the crop since 2002. According to statistics, India owes much of this success, which is often referred to as the White Gold Revolution, to Bt cotton. In 2011-12, India planted 12.1 million hectares of cotton, the highest-ever land under cotton cultivation. This significant increase in hectarage of cotton has been attributed, by and large, to the Bt technology, which has substantially increased profitability of cotton production in the country. Today, about 90 percent of the total cotton cultivation is under Bt cotton, which has resulted in tremendous increase in farmers' income across the country. Also, since the introduction of Bt cotton in 2002, when land under Bt cotton was 7.7 million hectares, India's cotton yield per hectare has increased by 60 percent. Bt cotton takes over Union Agriculture Minister Mr Sharad Pawar has praised the introduction of Bt cotton seeds by saying that it was a great step towards decreasing insecticide usage in the country. â€œWith the use of high quality hybrid cotton seeds, Indian farmers experienced the biggest gain in the form of reduced insecticide usage, from 46 percent in 2001 to less than 26 percent after 2006 and 21 percent in 2009 and 2010,â€? said Mr Pawar recently in Parliament. The number of cotton farmer cultivating cotton also increased significantly from five million in 2002-03 to eight million in 2011-12. Notably, the number of Bt cotton farmers increased from 50,000 in 2002-03 to seven million in 2011-12, representing approximately 88 percent of the eight million cotton farmers in 2011-12. Farm income too has enhanced with Bt cotton by 47,000 crore ($9.4 billion) in the period between 2002 and 2010, and 12,500 crore ($2.5 billion) in 2010 alone (Brookes and Barfoot report, 2012). â€œBt cotton has transformed cotton production in India by increasing the yield, decreasing insecticide applications, and contributed to the alleviation of poverty for over seven million small resource-poor farmers and their families in 2011 alone, and future prospects look encouraging,â€? says Mr Bhagirath Choudhary, national coordinator, International Service for the Acquisition of Agri-biotech Applications. Dr Arvind Kapoor, CEO, Vegetable division, Rasi Seeds, says due to higher prices of cotton lint and lower costs of cultivation, farmers are earning profits. â€œThat is why cotton sowing has increased and farmers are queuing up for good hybrids,â€? he adds. Expressing a similar opinion, Dr Seetharam Annadana, Traits Development & Vegetable R&D Management Lead, South Asia Syngenta, says, â€œThe best agricultural economist of India is the humble but very intelligent Indian farmer. If he is growing it, he finds value for it and, secondly, there is no better alternative to cultivation of GM cotton at present.â€? Quoting the report, State of Indian Agriculture 2011-2012, Dr Annadana says, â€œBt crop technology has more than doubled India's cotton production. By 2011-12, almost 90 percent of cotton area is covered under Bt cotton. More such revolutions to accelerate agricultural growth are needed.â€? Demand to go up Out of an estimated 8,000 crore seed industry, Bt cotton seed market is pegged at 3,000 crore. As per Cotton Association of India (CAI), the total cotton supply is estimated at 42.55 million bales, while the domestic consumption is estimated at 26.8 million bales, thus leaving 15.75 million bales as opening stock for 2012-13. While India produced 32.5 million bales (170 kg each) with 27.52 million acreage during the season ended September 2011, the next season's (October 2011- September 2012) output is projected to be 35.5 million bales from an acreage of 9.9 million acres (12.1 million hectares). The speedy migration of farmers to cotton from less profitable crops, such as oilseeds and pulses, has added to the forecast. Dr Arvind Kapoor of Rasi Seeds ruled out any scarcity of Bt cotton seed currently, but is skeptical about the future. â€œIn future there is a possiblity of scarcity due to higher costs of production and price control by government on cotton sale,â€? he says. According to sources, the demand for Bt cotton seeds for the 2012 kharif season is estimated to be 4.5-to-five crore packets, while the estimated stock with the seed companies is four crore packets. Earlier, the demand-supply gap led to black marketing of Bt cotton seeds in many states. Seeds and fertilizers were distributed under police protection in 2008 and 2009 in Maharashtra after riots over seed purchase. It was alleged that a few seed brands popular with farmers created an artificial shortage leading to strict vigil by the Maharashtra government last year. Variable seed prices As compared to other countries planting Bt cotton, India's Bt cottons are unique in the sense that they are hybrids and not varieties. The total value of cotton seed market is said to be around 3,500 crore. The cotton seed prices are fixed in each state depending on whether it is Bt Bollgard-I or Bollgard-II. The price varies in the range of 750 per packet for Bollgard-I to 900 per packet for Bollgard-II. In Punjab, Haryana and Rajasthan, the prices of Bt cotton seeds containing BG-I and BG-II traits are 750 per packet and 920 per packet, respectively. In other states, the prices of BG-I and BG-II cotton are 650 per packet and 750 per packet, respectively. The seed industry associations have requested the government to increase it to 850 and 1,050 per packet each. Giving a different take on the issue, Dr Gyanendra Shukla, director, Mahyco Monsanto Biotech (MMB), says, â€œThe cost of cultivation itself constitutes up to 60 percent of investment and seed price is only seven-to-eight percent of the total cost. Therefore, the seed price is a miniscule issue as the farmers may pay for a good seed that can give better yield.â€? On the current requirements, he adds, â€œOn the contrary, there is a requirement of new technology for further improvements of seed hybrids and the industry must be duly incentivized to bring down the cost of cultivation.â€? Due to shortage of Bt cotton seeds in the previous years, the state governments have been asking for written commitments from the seed companies about their supply plans. Owing to factors such as rainfall and seasonal variations in Bt cotton arrivals, the prices of cotton get affected. Although a seed shortage is expected, seed prices may not go up because Gujarat, Maharashtra and Andhra Pradesh governments have fixed the prices through legislation. In other states, there is an indirect price control because state governments ask for undertakings from seed companies that they will not sell seeds above the maximum agreed price. Commercially released varieties of Bt cotton approved by GEAC till 2010 Serial No Name of Company Number of approved hybrids Location 1 Ajeeth Seeds 20 Aurangabad, Maharashtra 2 Amar Biotech 55 Hyderabad, Andhra Pradesh 3 Ankur Seeds 38 Nagpur, Maharashtra 4 Bayer Biosciences 30 Hyderabad, Andhra Pradesh 5 Bioseed Research India 35 Hyderabad, Andhra Pradesh 6 CICR 1 Maharashtra 7 Emergent Genetics (now part of Monsanto) 1 8 Ganga Kaveri Seeds 19 Hyderabad, Andhra Pradesh 9 Green Gold 4 Aurangabad, Maharashtra 10 Global Transgene 5 Aurangabad, Maharashtra 11 JK Agri Genetics 38 Hyderabad, Andhra Pradesh 12 Kaveri Seeds 18 Hyderabad, Andhra Pradesh 13 Kohinoor Seed Fields India 3 New Delhi 14 Krishidhan Seeds 20 Pune, Maharashtra 15 MAHYCO (Maharashtra Hybrid Seeds Company) 33 Jalna, Maharashtra 16 Monsanto Holdings 11 Mumbai, Maharashtra 17 Metahelix Life Sciences 2 Bengaluru, Karnataka 18 Namdhari Seeds 15 Bengaluru, Karnataka 19 Nandi Seeds 22 Ahmedabad, Gujarat 20 Nath Seeds 12 Aurangabad, Maharashtra 21 Navkar Hybrid Seeds 11 Ahmedabad, Gujarat 12 Nuziveedu Seeds 84 Hyderabad, Andhra Pradesh 23 Palamoor Seeds 6 Hyderabad, Andhra Pradesh 24 Prabhat Agri Biotech 51 Hyderabad, Andhra Pradesh 25 Pravardhan Seeds 19 Hyderabad, Andhra Pradesh 26 ProAgro 2 New Delhi 27 Rasi Seeds 42 Attur, Tamilnadu 28 RJ Biotech 3 Aurangabad, Maharashtra 29 Safal Seeds and Biotech 9 Aurangabad, Maharashtra 30 Seed Works India 37 Hyderabad, Andhra Pradesh 31 Solar Agrotech 16 Rajkot, Gujarat 32 Super Seeds 8 Hisar, Haryana 33 Tulasi Seeds 35 Hyderabad, Andhra Pradesh 34 Uniphos Enterprises 22 Hyderabad, Andhra Pradesh 35 Vibha Agrotech 38 Hyderabad, Andhra Pradesh 36 Vikki Agrotech 1 Hyderabad, Andhra Pradesh 37 Vikram Seeds 20 Ahmedabad, Gujarat 38 Xylem Seeds 3 Hyderabad, Andhra Pradesh 39 Yashoda Hybrid Seeds 11 Wardha, Maharashtra 40 Zuari Seeds 4 Hyderabad, Andhra Pradesh Source: Indian GMO Research Information System Events approved in India for commercialization S No. Developed by Bt genes Events Year of approval 1 Mahyco cry1Ac MON-531 (Bollgard),licensed from Monsanto, US 2002 2 Mahyco cry1Ac and cry2Ab2, Stacked MON-15985 (Bollgrad II), licensed from Monsanto, US 2006 3 JK Agri Genetics cry1Ac Event-I, sourced from IIT, Kharagpur (India) 2006 4 Nath Seeds cry1Ab and cry1Ac, fused Even-GFM sourced from China 2006 5 Central Institute of Cotton Resaerch, Nagpur and University of Agricultural Sciences, Dharwad cry1Ac Event BNLA-601 2008 6 Metahelix Life Sciences cry1C Event MLS-9124 2009 Source: ABLE AG Cotton cultivation in the last seven decades Cotton cultivation in the last seven decadesYear Area in lakh hectares Production in lakh bales of 170 kgs Yield (kgs per hectare) 1950-51 58.82 34.3 99 1960-61 76.1 60.12 134 1970-71 76.05 56.64 127 1980-81 78.23 78 169 1990-91 74.39 117 267 2000-01 85.76 140 278 2001-02 87.3 158 308 2002-03 76.67 136 302 2003-04 76.3 179 399 2004-05 87.86 243 470 2005-06 86.77 241 472 2006-07 91.44 280 521 2007-08 94.14 307 554 2008-09 94.06 290 524 2009-10 103.1 305 503 2010-11 111.42 339 517 2011-12 121.91 345 481 Source: Cotton Advisory Board Rahul Koul in New Delhi ]]> <![CDATA['We have a strong and diversified pipeline of novel targets]]> https://biospectrumindia.com/news/95/2495/we-have-a-strong-and-diversified-pipeline-of-novel-targets.html https://biospectrumindia.com/news/95/2495/we-have-a-strong-and-diversified-pipeline-of-novel-targets.html Tue, 10 Apr 2012 16:20:00 +0530 Dr Suri Venkatchalam,CEO, Connexios Life Sciences Dr Suri Venkatchalam started Connexios Life Sciences in 2003 with an aim to bring out one-of-the-first novel therapeutic drug in India. He started the firm, with venture backing from Nathadur Holdings, following his stint at Metahelix. Now, more than nine years later, Connexios has managed to develop a strong pipeline of drugs in metabolic disorders with special focus on diabetes, with one candidate ready to be taken to the clinics this year. Connexios provides the right kind of environment for companies to successfully spin off ventures with their own core competencies, as has been the case with Abexome Biosciences and Achira Labs. In a conversation with BioSpectrum, Dr Suri, who has a diverse academic background-ranging from graduation in chemical engineering to a PhD in physics and post doctoral studies in various aspects of biology, speaks about the challenges faced by a novel drug discovery company in forging strong partnerships for successfully commercializing drug candidates. Q What is your strategy for the novel drug discovery domain and what have been the results so far?  Dr Venkatchalam:  We started with the principle of looking at biological systems as an interconnected, integrated biology network. Our approach is a modelling one, to understand the concept of disease that combines network biology, computational biology and experimental validation. If we understand these networks, we would understand cellular functions and hopefully the disease. We were a very small team when we started, today we are a fully-integrated drug discovery company focussed on developing a diversified pipeline of drugs, mostly in metabolic diseases. However, the technology that has been developed has broad implications in other diseases as well. We have a fairly strong and diversified pipeline of novel targets and early stage candidates. One of them, a GPR 40 agonist for diabetes, is ready for clinical trials and there are about four more to follow in the same line. We have six active pipeline programs. Our research activities can be broadly classified as 60 percent in drug discovery and 40 percent in basic biology research for target discovery among others. Using basic research, we are also trying to find biomarkers, which can translate into diagnostic tools, which the clinician can use to differentiate between patients of the same disease. We are also trying to develop biomarkers as companion diagnostics in the development of compounds. The work is a combination of using bioinformatics as well as wet lab experiments. Q Drug discovery is marked by low success rates. As a mid sized company, what is your strategy to counter this?  Dr Venkatchalam::   When it comes to selecting targets, we chose those that are sitting at the hub of metabolic disorders. These can have an in-built ability to be repurposed for other diseases where the same cellular functions have been implicated. We try to incorporate complex biology early on in the drug discovery chain to increase the value and efficacy of the compound. This gives us a better chance of getting best in class compounds as you are looking at the entirety of the problem. Q What differentiates Connexios from other life sciences companies?  Dr Venkatchalam:  What differentiates us is our integrated approach to select targets and screen compounds at a price that allows us to do more projects. Our strength in doing this has enabled us to stay alive for the last nine years. You need a critical level of information, which requires time, and we have had a very supportive investor, who is in for the long run. In that sense, we are very unique globally to have been given this time to build such an expertise from an information as well as people perspective, to straddle multiple points in the entire chain. There are many other people who are building pipelines for novel therapeutics, but we have differentiated ourselves because of our rigorous approach towards biology. Also, the culture at Connexios is self perpetuating, allowing people to express and follow through with their own ideas as has been the case with Abexome and Achira. Today, we are a fairly large company from a people's perspective with around 190 people spread across three locations in Bangalore. Q With rapid changes taking place in the pharma industry worldwide, what are the steps you have taken to stay afloat?  Dr Venkatchalam:  Our revenue model is focused on building a strong proprietary pipeline and then out licensing it to a partner to further test it in clinical trials, just like classic licensing programs. That is what we are doing now. Keeping in line with that, we are actively looking for partners for trials who can share some risk in the development of the GPR 40 agonist. Our goal has always been to build a pipeline and find partners and we hope that these partnerships will lead to some kind of cash inflow as well. And as some of the risks start yielding returns, we hope that the partners come back, which will allow us to take bigger risks.We want to be an innovation driven, biology-based drug discovery company, developing innovative therapeutics by leveraging our understanding of metabolism with current focus on diabetes. Over time we would like to be either with our partners or on our own, and see our compounds in later stages of discovery and clinics. Q How do you view the venture capital scene for life sciences companies in India?  Dr Venkatchalam:  Our situation is very unique in India, but our investor is also very unique. Nathadur is not a typical investor, and our relationship with the life sciences arm, Group LifeSpring, is more of a partnership than just an investor. It is not a typical venture capital (VC) model. The VC model for life sciences itself is under stress worldwide because of the fluctuations in the pharma market. Flexibility is needed when it comes to the life sciences industry. Being a family group, flexibility is something Nathadur can control as it is in their hands, which is what life sciences companies like ours require. Q There is a lot of emphasis on biosimilars and generics in India. Where do you see yourself as a novel drug discovery company?  Dr Venkatchalam:  The requirements for drugs is so vast that the need for novel drugs will always remain as existing drugs. The way I see it, we and other generics companies are addressing non overlapping markets. We are focused on markets that have an appetite for novel drugs. The larger problem of making such novel drugs affordable to the public needs to be addressed by the industry and the government. Q Can you describe the challenges that you are currently facing?  Dr Venkatchalam:  Today, our main challenge is to find the right partners so that we can take our compounds further into clinical trials. One can regulate the costs in the pre-clinical development of drugs. In the clinic, however, controlling costs become difficult. That is why we are looking for partners. We need to have creative partnerships. Also, government funding is another interesting aspect that we might look into for trials. In a drug discovery company, the last word is when a research is translated into product. We are very hopeful as we have more options, lower costs, greater staying power, a supportive investor and the ability to tide over difficult situations Manasi Vaidya in Bangalore ]]> <![CDATA['We are looking at 400% growth']]> https://biospectrumindia.com/news/95/2659/we-are-looking-at-400-growth.html https://biospectrumindia.com/news/95/2659/we-are-looking-at-400-growth.html Tue, 10 Apr 2012 16:16:00 +0530 Dr B V Ravi Kumar,founder chairman and MD, XCyton Diagnostics XCyton Diagnostics launched a path breaking invention called syndrome evaluation system (SES), the world's first critical care therapeutic decision support system that will result in effective treatment. SES is a patented technology comprising rapid multiplex amplification and accurate identification of the virulence associated genes of the causative agents or organisms. SES allows simultaneous identification of multiple organisms, including bacteria, viruses, fungi and parasites, in a specific test from a single sample. The accurate and rapid identification of the causative agents that usually comprises seven hours of process time empowers the clinician to initiate targeted therapy thus saving lives and significantly reducing disabilities, such as blindness, paralysis and compromised mental faculties. XCyton, which presently has scientific staff of 10 individuals, has a revenue of approximately 1.5 crore. In an interaction with BioSpectrum, Dr B V Ravi Kumar, chairman and managing director, XCyton Diagnostics, shared his views on the market opportunities for SES and the company's strategies to enter the untapped market in India. Q What is the current trend of the critical care infections market in India? How do you see the market opporunity for SES in India?  Dr Kumar:  Currently, the trend is mainly in automated culture machines, immunological tests and a few polymerase chain reaction (PCRs) for tuberculosis (TB). The exact size of the market is uncertain. However, the episodes of critical infections are about 1.5 million admissions in private hospitals alone. Only eight-to-17 percent get diagnosed and the rest are not due to limitations in the sensitivity of all conventional tests. SES is fulfilling both gaps, including diagnosis time and sensitivity, which is more than 75 percent. We believe that as early entrants, with a service that takes care of both the gaps in standard care, we should capture atleast 30 percent of this market in next five years. Q What marketing strategy has XCyton adopted to promote SES in India?  Dr Kumar:  SES is offered as a molecular diagnostic services by XCyton. We will establish labs across the country so that samples from intensive care unit (ICUs) can reach the labs within 12 hours, including transporation time, so that a report can be given to the doctor within 20 hours after admission to ICU. Q What share of the critical care infections market for micro biology are you looking at?  Dr Kumar:  XCyton has just launched the SES service. We will focus on developing the network and bringing it to maturity. Q What kind of support does Fidelity Growth Partners India provide to XCyton?  Dr Kumar:  Fidelity Growth Partners India brings in financial support for the marketing of SES. They also bring the bandwidth to take it overseas, where there is tremendous potential. Q What growth rate will the company be looking at with the launch of SES?  Dr Kumar:  With the launch of SES, we are looking at a growth rate of 400 percent in the coming year, which is the first marketing year. Narayan Kulkarni in Bangalore ]]> <![CDATA['Third generation sequencing is superior to NGS']]> https://biospectrumindia.com/news/95/2383/third-generation-sequencing-is-superior-to-ngs.html https://biospectrumindia.com/news/95/2383/third-generation-sequencing-is-superior-to-ngs.html Tue, 10 Apr 2012 16:14:00 +0530 Mr Neeraj Gupta,director - sales & marketing, Imperial Life Sciences, Gurgaon Gurgaon-based Imperial Life Sciences (ILS) provides complete solutions in instrumentation, reagents, bioinformatics and consumables. The company has also diversified into flow cytometry business. Recently, it entered into a collaboration with Pacific Biosciences in the area of third generation sequencing. With a mix of existing and new partners, the company is looking at continuing to consolidate its business. The company has a team of more than 130 highly-qualified professionals and has had consistent growth rate. It has formed new tie ups and is looking forward to entering the field of diagnostics in a major way. BioSpectrum spoke to Mr Neeraj Gupta, director - sales and marketing, ILS on the company's new strategy, focus, market trends and future. Q What is the current focus area of ILS? We recently got into various new dimensions, including third generation sequencing, which is far better than the existing next generation sequencing (NGS). Earlier people were highly excited about the NGS, but third generation sequencing is far superior to the existing technologies. Launched in April in the US, third generation sequencing from US-based Pacific Biosciences was brought to India in August 2011 by ILS. The NGS as compared to the capillary sequencing brought down the time period significantly, but it too has its own nemeses. It can read only 30 bps to 300 base pairs (bps) and there is overlapping of data, which is generated in huge quantity. Thus it requires stitching to make data readable and is time-consuming. Third generation sequencing by Pacific Biosciences is a disruptive technology that takes care of all the nemeses of the NGS at a striking 1/10th of its cost per sample. Having an average read length of aproximately 3,000 bps (with highest documented upto 8,000bps); the data is much cleaner and also takes care of overlapping. Also, the recurring cost per sample is as low as $350, when compared to $8,000 cost per sample of NGS. Q What do you consider as the major business drivers? The product range from New England Biolabs and Affymetrix have been significant business drivers. Besides that, Caliper and Miltenyi Biotec have been significant revenue generators. Earlier, we used to have 70 percent revenue from instruments and 30 percent from consumables. Currently, we have 60:40 ratio and are looking at making it 50:50 in the near future. The myth of microarray being outdated compared to NGS has been busted and researchers are taking microarrays to new heights with latest and novel applications. We sold 12 scanners in the last year alone, a thing which has never happened in the past. Q How competitive is the market for you? The market is certainly full of competition as the clients have more options available to choose from. Besides that, it is a fact that the market is slightly biased towards the internationally-branded products. However, we believe in providing quality products to our clients and, therefore, continue to maintain close association with all our key clients. There was a time when we were watching the situation very carefully but as per our market understanding, things went the way we expected. I feel client service plays an important role in India. Since the channel partners are well versed with the customer behavior, buying trends and changing requirements, it is very difficult to ignore them and carry out business. The global companies decided to enter the Indian market to consolidate their businesses but of late it has failed to work wonders for these companies. So they are falling back on the channel partners to carry out their operations. Q What kind of growth are you expecting in this financial year? Consistent growth will be the trend this year too. The addition of new and state-of-the-art technologies in the company's product portfolio and consistent performance of the present technologies will steer us to a steady growth of 20-25 percent in the FY 2011-12. Q What are the challenges before you? The challenges are many including the lack of custom tax benefits. Since biotechnology is directly connected to the welfare of common masses, the government must definitely relax a few of its rules for the growth of the industry. Q What is the future outlook of the company? I feel India still has a deficit in terms of the technologies available in the advanced molecular diagnostics space. Therefore, we have wanted to enter this area for long and have now tied up with Affymetrix, which focuses on personalized diagnostics in a big way. We are bringing the FDA-cleared assays aimed at hospitals and clinicians to India. We are planning to expand our portfolios in genomics, molecular imaging and spectroscopy. Q How do you think the biotech market will shape up in the future? The biotechnology market in India is comparatively smaller to the global size, and there are a lot of regulatory hurdles also. However, since the industry is growing at a good rate, we should be making remarkable progress in the coming years. Manasi Vaidya in Bangalore ]]> <![CDATA[PPP: Energy security with biofuels]]> https://biospectrumindia.com/news/95/2013/ppp-energy-security-with-biofuels.html https://biospectrumindia.com/news/95/2013/ppp-energy-security-with-biofuels.html Tue, 10 Apr 2012 15:08:00 +0530 This month, the series on public-private partnerships focuses on biofuel research being pursued by various organizations. The three case studies elucidate significant work done towards achieving energy security in the country Richcore Life Sciences has developed a technology that enhances ethanol yield from molasses fermentation with funding from Department of Biotechnology. SBIRI funding has helped Nandan Biomatrix to carry out micropropagation of its two hybrid varieties of disease-free Jatropha plants that can be cultivated for enhanced production of biodiesel. Mysore-based Labland Biotechs is also focusing on mass cultivation of superior high yielding Jatropha plants to meet the huge demand for sustainable production of biodiesel. ]]> <![CDATA[Mission: High yielding Jatropha for biodiesel]]> https://biospectrumindia.com/news/95/1208/mission-high-yielding-jatropha-for-biodiesel.html https://biospectrumindia.com/news/95/1208/mission-high-yielding-jatropha-for-biodiesel.html Tue, 10 Apr 2012 15:01:00 +0530 The DBT funding has provided a much-required boost to Mysore-based Labland Biotechs to focus on mass cultivation of high yielding Jatropha plants for sustainable production of biodiesel Besides the fact that biodiversity in the natural population of Jatropha curcas is narrow, the attempts at producing improved varieties of the plant through tissue culture too have been very limited. Jatropha is a source of biofuel and it can be planted in marginal lands. Improved varieties of the plant can attract rural farmers with marginal lands for Jatropha plantations, which will help to increase biodiesel production. Mysore-based Labland Biotechs chose to address this issue by following a systematic technology for mass production of elite Jatropha curcas clones from its own germplasm center. The major objective of the project, costing over 440 lakh, was to develop a tissue culture production facility for micro-propagation of elite Jatropha curcas plants with higher yield of seeds and oil of superior quality. There are 70 employees at various levels contributing to the successful implementation of the project. A soft loan from the Department of Biotechnology under the Small Business Innovation Research Initiative (SBIRI) scheme provided the much-needed impetus to the project. Labland has developed a tissue culture production protocol for Jatropha curcas through direct organogenesis and axillary shoot proliferation, using elite adult plants. A patent is pending for the protocol. These clones have been established in the demonstration fields for stabilizing of agronomical traits through field evaluation and fidelity testing. The technology complements the supply of plantlets to meet commercial demand of quality planting material required for growing Jatropha plantations for oil production. Dr Geetha Singh, managing director, Labland Biotechs, explains the beginning of the project. â€œRather than us approaching the DBT, it was the other way round. A presentation by Dr Sudheer Shetty, chairman of Labland, at a national conference on biofuels in 2006 prompted the DBT to invite us to present our achievements on Jatropha at the national micromission,â€? she says. Based on subsequent discussions and advice of the DBT, Labland submitted a proposal for the project that was sanctioned in August 2007. Talking about the importance of the SBIRI funding, Dr Singh says, â€œIt was very beneficial as it helped us to establish a dedicated tissue culture production facility for Jatropha curcas at Mysore. For the first generation biotech entrepreneurs, this fund support is a welcome concept and is a commendable program.â€? The way forward Successful completion of the project has enabled commercial production of plantlets at the dedicated facility for distribution among planters to raise Jatropha estates. Further, improvement of indigenous lines has enabled the production and supply of elite clones of Jatropha curcas to increase economic benefits to Jatropha growers. During the project period, the company also created a niche market for supplying Jatropha multi-cultures to research institutions and commercial organizations in India and abroad. The tissue culture facility's annual production is 15 lakh plantlets and five lakh greenhouse-hardened pot plantlets of Jatropha curcas. Rahul Koul in New Delhi ]]> <![CDATA[Mission: Disease-free Jatropha hybrids]]> https://biospectrumindia.com/news/95/2656/mission-disease-free-jatropha-hybrids.html https://biospectrumindia.com/news/95/2656/mission-disease-free-jatropha-hybrids.html Tue, 10 Apr 2012 14:58:00 +0530 Support in the form of SBIRI funding helped Nandan Biomatrix to carry out micropropagation of its two hybrid varieties of disease-free Jatropha plantlets that can be cultivated for enhanced production of biodiesel Some of the diseases found on Jatropha plants are leaf spot, leaf rust, downy and powdery mildews, stem and root rot. Also, seedling die-back and collar-rot are common in Jatropha nurseries. Moreover, disease incidence can be severe when the plants are grown under irrigation in semi-arid environments. To tackle this issue of diseased plantlets leading to decreased yield, Hyderabad-based Nandan Biomatrix has developed high yielding Jatropha curcas hybrids. The mass multiplication of Nandan-1 and Nandan-2 through micropropagation is expected to generate disease-free plantlets, which in turn can be cultivated in large acreages for enhanced production of biodiesel. The project has found support in the form of funding from the Small Business Innovation Research Initiative (SBIRI), a scheme launched by the Department of Biotechnology (DBT) under the Ministry of Science and Technology for funding early-stage, pre-proof of concept research in the field of biotechnology. The project involves development of an efficient micropropagation protocol for J. curcas hybrids, Nandan-1 and Nandan-2, and standardization of cost-effective tissue culture media for mass multiplication. The project has various stages. It starts with finding the best tissue culture conditions for regeneration of the two hybrids. Then, the testing of different media compositions for rapid bud breaking media, multiple shoot induction, elongation and rooting media will be carried out. Also, the best acclimatization condition has to be found and quantification of the regeneration level and cost calculations are to be carried out. Following this, the tissue culture plants have to be evaluated in experimental fields through agronomic trials to test the level of pest and disease infestation. Mr C S Jadhav, director-marketing, Nandan Biomatrix, says the SIBRI funding was a great help. â€œIt aims to strengthen existing private units with in-house innovative R&D and to create opportunities for starting technology-based or knowledge-based businesses in biotechnology and to stimulate technological innovation and product commercialization. Further, the SBIRI encourages other smaller businesses to increase their R&D capabilities and capacity, and uses private industries as a source of innovation, thereby fulfilling the government objective of fostering R&D,â€? he says. The way forward The project, started in January 2012, is progressing well with different sets of in vitro experiments being carried out. It is well-known that Jatropha can be grown in marginal and waste lands and requires very little input costs. A high-yielding Jatropha can generate interest among Jatropha growers for sustainable and profitable cultivation of the plant leading to higher production of biodiesel. â€œThe outcome of the project looks bright with development of an efficient and cost-effective mass multiplication technique. Micro-propagation will be a handy tool for production of plantlets of Nandan-1 and Nandan-2 hybrids that are high-yielding and would be uniform in growth, besides being disease-free. Also, the economic interest of Jatropha growers can be upheld, along with that of the processors and end users,â€? says Mr Jadhav. Rahul Koul in New Delhi ]]> <![CDATA[Innovation-driven research]]> https://biospectrumindia.com/news/95/1756/innovation-driven-research.html https://biospectrumindia.com/news/95/1756/innovation-driven-research.html Tue, 10 Apr 2012 12:37:00 +0530 In this issue, the CSO Series brings the profiles of three scientists who are doing innovative work in their respective fields. While one of them is working on immunology, the other two are working on drug discovery and platform technology spaces. Dr Dinakar M Salunke, executive director of Regional Centre for Biotechnology, has made outstanding contributions to the understanding of generation of antibody diversity and in elucidating the various facets of molecular mimicry. Dr Ashok Kumar, president-Centre for Research and Development, IPCA Labs, is leaving no stone unturned to exploit the biotech and drug discovery space and steer the company towards achieving product patents. Dr Ganesh Sambasivam has given Anthem Biosciences the tag of contract innovation service provider by focusing on innovative platform technologies to better serve the clients. ]]> <![CDATA[Innovation in contract research]]> https://biospectrumindia.com/news/95/2505/innovation-in-contract-research.html https://biospectrumindia.com/news/95/2505/innovation-in-contract-research.html Tue, 10 Apr 2012 12:35:00 +0530 Dr Ganesh Sambasivam CSO, Anthem Biosciences Anthem Bioscience is more of a discovery company than a run of the mill contract research organization with strong emphasis on developing innovative platform technologies. Chief Scientific Officer and co-founder Dr Ganesh Sambasivam believes this has allowed Anthem to show an appreciable growth in times of turbulence in the pharma industry. After completing his bachelor's degree in chemistry, Dr Ganesh Sambasivam wrote the national-level entrance exam for a master's program in organic chemistry from the University of Pune. He says it was a whim that made him take the exam and considers himself to be lucky that he emerged among the top 20 students who were awarded scholarships for the course. This further encouraged him to pursue his PhD at the same university. His interest in organometallics translated in his PhD thesis, which was completed in four years. After his PhD, Dr Ganesh was presented with a unique challenge to set up a chemistry-based services company from scratch in Bangalore. The opportunity was big, and so were the challenges, but Dr Ganesh took them head on and helped establish Syngene. Dr Ganesh recalls the difficulties he faced during those times and says it prepared him for a second innings. â€œInitially, it was very tough to set up Syngene. We used to spend more than 18 hours in the lab. However, it was a lot easier after about a year when the results started to show. I was there for over 12 years as the vice-president and CSO. The experience made my second innings as an entrepreneur easier,â€? he says. After heading several successful projects at Syngene, Dr Ganesh, along with two other colleagues, decided to start their own company. It has been almost six years since Anthem Biosciences was set up and close to half a dozen patents in the platform technology space have been filed. Dr Ganesh says they like to call themselves a contract innovation service provider. â€œThere are certain negative connotations associated with CROs in the industry. In order to differentiate ourselves, we want to develop platform technologies that can be used while providing services and can also be out-licensed,â€? he explains. He gives the example of a technology developed at Anthem. â€œScreening drugs for genotoxicity is very difficult. We developed the high throughput-compatible human cell-based genotox platform, where we have genetically engineered cells to have three biosensors with luminescent reporter genes. The results of this assay can be read with a luminometric readout where multiple genotoxic pathways in a cell can be targeted,â€? he says, adding that the current methods used for genotoxicity screening approved by the USFDA are time-consuming. â€œThis will hopefully offer a good solution as it also reduces the use of laboratory animals. It has recently been selected as one of the top 50 innovations of 2012 by DST-Lockheed Martin (University of Texas). We are writing research papers for it in collaboration with some universities,â€? he adds. Dr Ganesh says Anthem did not get into new chemical entity (NCE) development. However, when one of their clients shut shop, Anthem acquired the rights to an NCE in the nutritional supplement category that was a resveratrol analogue. Resveratrol is an antioxidant commonly found in wine and is widely believed to have anti-inflammatory and anti-cancer properties. This analogue has high bioavailability as compared to resveratrol. After further development, the product was recently launched by Anthem Cellutions, which is co-owned by one of the founders of Anthem Biosciences. Other interesting projects at Anthem that Dr Ganesh heads include a novel platform to get high productivity from commercial enzymes. The company has received a Biotechnology Industry Partnership Programme grant from Department of Biotechnology for the project. Manasi Vaidya in Bangalore ]]> <![CDATA[IPCA]]> https://biospectrumindia.com/news/95/1614/ipca.html https://biospectrumindia.com/news/95/1614/ipca.html Tue, 10 Apr 2012 11:52:00 +0530 Dr Ashok Kumar president- Center for R&D, IPCA Labs The 25-year process patent regime allowed a large number of generic companies in India to reap rich dividends, but there were few who believed in the need to go beyond the horizon of process development to tap into unexplored terrains. In the year 2000, when Dr Ashok Kumar joined the board of Mumbai-based IPCA Labs, he was determined to implement a different strategy to accelerate IPCA's R&D initiatives. Having seen IPCA grow from a 350-crore company to one clocking an annual turnover of over 2,500 crore, Dr Ashok Kumar, president- Center for Research and Development, IPCA Labs, is now leaving no stone unturned to exploit the biotech and drug discovery space. Dr Kumar completed his M Sc in Chemistry from Kumaun University, now in Uttarakhand. He then decided to pursue his PhD in organic chemistry and joined Banaras Hindu University (BHU), but opted out three months later to do PhD from the Central Drug Research Institute (CDRI), Lucknow, under the guidance of the then director of the CDRI, Dr Nityanand. Dr Kumar did his post doctoral studies from the University of Sussex, UK. â€œDuring the 1980s, jobs in scientific research were not available in India. It was always good to go for higher studies abroad,â€? he says about the reason for going abroad. â€œDr Nityanand taught me to be explorative and think of new ways to approach a subject. I still follow that process,â€? he says. In 1984, Dr Kumar decided to return to India and took up a job at the Imperial Chemical Laboratories (ICI), Mumbai. In 1994, he joined Lupin Labs where he was once again involved in process development of small molecules. In 2000, he joined IPCA Labs where he immediately focused on bringing about two changes â€“ introducing a library and bringing in systems like a nuclear magnetic resonance (NMR), which at that time was the costliest instrument. â€œI understood the importance of high-end technologies since my PhD years at the CDRI (which housed a couple of NMRs) and then in the UK. You do not enjoy organic chemistry without an NMR. My main objective at IPCA was cost reduction along with process development.â€? In the last few years, IPCA's R&D team has brought out over 100 products. Under Dr Kumar, IPCA has an R&D center in Mumbai and another parallel R&D center in Ratlam, Madhya Pradesh. â€œIn Mumbai, we have around 60 people. The Mumbai team takes care of basic chemistry and small-scale development. Scaling up is done in Ratlam,â€? he explains. IPCA is also coming up with a facility at Vadodara, Gujarat, that will look into large-scale manufacture of both organic and biotech drugs. The facility will have a strategic importance for the company. â€œWe are growing at a rate of 20 per cent year-on-year and, next year, we intend to add 500 crore to our revenue. For that, we need more products to come to the market and more volume,â€? he adds. Apart from organic chemistry, Dr Kumar is currently aligning his attention to two promising but high risk segments - fermentation-based products and biosimilars. â€œWe are working on five-to-six molecules, mainly active metabolites that are intermediates or biotech drugs,â€? he adds. IPCA has also collaborated with two companies in India for the development of biosimilars. Currently, there are three biosimilar products in the pipeline. The R&D team at IPCA ventured into drug discovery three years ago. It has two products in the pipeline; one anti-malarial and the other anti-thrombotic. â€œWe will be filing the investigational new drug application for one molecule this year and for the other next year. The success rate here is 99 per cent,â€? adds Dr Kumar. IPCA has also joined hands with the CDRI and licensed two molecules in the anti-malarial space. One of these molecules is currently in phase-I stage. Nayantara Som in Mumbai ]]> <![CDATA[Molecular mimicry master]]> https://biospectrumindia.com/news/95/2433/molecular-mimicry-master.html https://biospectrumindia.com/news/95/2433/molecular-mimicry-master.html Tue, 10 Apr 2012 10:25:00 +0530 Dr Dinakar M Salunke executive director, Regional Center for Biotechnology, Gurgaon With his 30 years of experience in research, Dr Dinakar M Salunke has made outstanding contributions to the understanding of generation of antibody diversity and in elucidating the various facets of molecular mimicry in the context of humoral immune response. He has successfully analyzed several chemically dissimilar but functionally equivalent molecular structures, establishing structural basis and immunological implications of molecular mimicry. Currently working at the National Institute of Immunology (NII), Delhi, Dr Salunke is busy nurturing the Regional Center for Biotechnology (RCB) as its first executive director. The center is an institution of education, training and research established by the Government of India under the auspices of the United Nations Educational, Scientific and Cultural Organization. Dr Salunke's research journey began in 1978 when he joined Prof M Vijayan for his PhD degree in molecular biophysics at the Indian Institute of Science, Bangalore. Following this, he set out for Brandeis University, Waltham, Massachusetts, USA, for his post doctoral research in 1984 under Prof DLD Caspar, a renowned structural biologist. He returned to India in 1988 to join the NII where he developed a strong group in structural biology, addressing issues concerning immune mechanisms. His research on the pluripotency of primary immune response led to the discovery of new ways of antibody degeneracy and has impacted the evolving paradigm shift in immune recognition and generation of antibody repertoire. He also analyzed how the immune system reacts when it encounters antigens that keep changing shape. He also showed that the restricted paratope conformational repertoire, on binding of an antigen to multiple independent antibodies, may be relevant for minimizing possibility of self-reactive antibodies. Utilizing the structural, immunological and thermodynamic approaches, Dr Salunke's group addressed the molecular insights into functional mimicry in the context of immune response. His team has successfully demonstrated that the antibody paratope plasticity could facilitate molecular mimicry of otherwise unrelated antigens. His group also demonstrated the structural basis of molecular mimicry involving porphyrins and sugar moieties as well. â€œWhile our analysis of carbohydrate-peptide mimicry provided important conceptual leads towards design and development of new generation vaccines, the analysis involving carbohydrate-porphyrin mimicry provided possible mechanistic understanding of the molecular pathology of porphyria,â€? says Dr Salunke. In 2000, he received the Shanti Swarup Bhatnagar Prize for Science and Technology in the category of biological sciences. He also received the National Bioscience Award in 1999, recognition from the National Institute of Immunology for outstanding scientific achievements consecutively in 2000 and 2001, and Ranbaxy Research Award for Basic Research in Medical Sciences in 2002. More recently in September 2011, the Council of Scientific & Industrial Research bestowed on him the GN Ramachandran Gold Medal for Excellence in Biological Sciences & Technology for the year 2010. Dr Salunke, who started as a student of physics and mathematics, moved to molecular biophysics and finally utilized these skills in modern biology. He strongly believes that multi-disciplinary approach to biotechnology will create more effective researchers. The RCB, where he is actively involved in developing advanced educational and training programs, is expected to create opportunities for students to engage in research where they will learn the discovery tools by appropriately integrating science, engineering, medicine and agriculture to provide healthcare solutions and to develop agricultural and environment technologies. Rahul Koul in New Delhi ]]> <![CDATA[Budget disappoints India biotech industry]]> https://biospectrumindia.com/news/95/5503/budget-disappoints-india-biotech-industry.html https://biospectrumindia.com/news/95/5503/budget-disappoints-india-biotech-industry.html Tue, 10 Apr 2012 10:21:00 +0530 The 200 percentage weighted tax deduction by companies on research and development (R&D) expenses will continue till March 31, 2017. However, the biotech industry's demand to extend these provisions to outsourced R&D and clinical trial expenses have not been accepted In the decade dedicated to innovation, the biotech industry, which relies heavily on innovation, is not on top of the Government of India's priorities listed in the Union Budget for 2012-13. The only saving grace in the budget presented in Parliament on March 16 is that the 200 percentage weighted tax deduction by companies on research and development (R&D) expenses will continue till March 31, 2017. However, the biotech industry's demand to extend these provisions to outsourced R&D and clinical trial expenses have not been accepted. These two are key components of innovative drug discovery and the industry is disappointed by the government's neglect of this activity. In fact, while the budget has talked about reducing import duty on some life-saving medicines, vaccines, for which the Indian industry is acclaimed the world over, will become costlier. The budget has proposed doubling of excise duty on finished vaccines, from one to two percent, and further slapped duties on imported raw materials. Then there is additional service tax on many aspects of the business. However, import duty on some key medical equipment and stents have been reduced by half to 2.5 percent.   Highlights   Five-year extension of 200 percent weighted tax deduction on R&D expenses Setting up of 50 billion India Opportunities Venture Fund with SIDBI for MSME Import duty on some key medical equipment and stents reduced by half to 2.5 percent Excise duty on finished vaccines increased from one to two percent 100 percent coverage for National Immunization Programme Hike in excise duty on raw materials from 10 percent to 12 percent Allocation of 200 crore for development of new technologies for seeds and plants Agri universities in Orissa, Haryana, Karnataka, Kerala and Andhra Pradesh to get a combined bonanza of 350 crore Weighted deduction of 150 percent on expenditure incurred for agri-extension services Outlay for Rashtriya Krishi Vikas Yojana that covers animal healthcare sector increased from 7,860 crore to 9,217 crore Plan to set up integrated vaccine unit at Chennai Yet, the Finance Minister has proclaimed that in the wake of successful elimination of polio due to vaccination in the country, the national immunization program will target 100 per cent coverage. Currently, vaccination coverage hovers around 76 per cent for essential vaccines. The budget has tried to increase modern seed production, but not specifically the transgenic seed varieties. The good news on this front is that premier agricultural research centers, the Kerala Agriculture University, Trichur, and the University of Agricultural Sciences at Dharwad, Karnataka, will get 100 crore and 50 crore, respectively, as special grant to boost research. Few other agricultural universities in Orissa, Haryana and Andhra Pradesh will get a combined bonanza of 200 crore in the budget. Small biotech companies could look forward to raising some capital from the new stock exchange for small and medium enterprises. The budget has allocated 5,000 crore to help the exchange through the funding organization, Small Industries Development Bank of India. The Association of Biotechnology Led Enterprises (ABLE), a national forum that represents $4 billion biotechnology industry in India, while welcoming some of the measures, said it is disappointed that there was no major announcement to spur innovation and growth of the biotech sector, at a time when the government has declared this as the 'Decade of Innovation'. On the agriculture front, ABLE is happy to note the allocation of 200 crore for the development of new technologies for seeds and plants and a grant of 350 crore to agriculture universities across the country, which will ensure that the benefits of technology in agriculture reach the citizens of the country. Reactions: Budget 2012 The industry was largely disappointed with the provisions of the budget. Ms Kiran Mazumdar-Shaw, CMD, Biocon, said, â€œI expected nothing out of this Union Budget, and the Finance Minister has certainly met my expectations.â€? According to her, the government's proposal to tax foreign shareholding with retrospective effect is a â€œhighly retrogressive step that will have serious implications on India's economy and businessâ€?. â€œInstead of using this budget to proclaim that India is open to business, the government is closing the doors. It appears to be the administration is agenda. Their objective is to raise revenues from any source possible. This is one rollback the government must effect immediately,â€? she added. â€œI expected nothing out of this Union Budget, and the Finance Minister has certainly met my expectations... A highly retrogressive step that will have serious implications on India's economy and business.â€? - Dr Kiran Mazumdar-Shaw, CMD, Biocon She, however, had a word of praise on the extension of 200 percent weighted deduction on R&D. â€œI am pleased that the Finance Minister has extended by five years the 200 percent weighted deduction on R&D. The formulation of special guidelines to allow small and medium-sized enterprises (SMEs) to list on stock exchanges can help biotech start-ups get access to the much-needed funding,â€? she said. Mr Nitin Deshmukh, member, executive council of ABLE, and CEO, Kotak Private Equity, said, â€œThe 5000-crore allocated to SIDBI for Micro, Small and Medium Enterprises (MSMEs) is a very welcome step and many small biotech companies will benefit from this.â€? He added that the reduction of customs duty from five percent to 2.5 percent on medical devices and CVDs, such as stents and valves, and customs duty reduction on vaccines, life-saving and anti-cancer drugs are also welcome measures. According to Dr Krathish Bopanna, president & executive director, Semler Research Centre, the budget proposes â€œa number of regressive, retrograde and extraterritorial provisions that would significantly increase tax and alter the dynamics of cross-border transactions and M&Asâ€?. â€œIt raises a question as to whether foreign investments are protected in India at all and whether it will give rise to claims under bilateral investment protection treaties,â€? he said, adding that indirect taxes, service costs and excise duty would hurt the industry in a big way. Mr Supreet Deshpande, CEO, VLife Sciences Technologies, comments that this is â€œone of the most uninspiring budgetsâ€?. â€œUnsure strategies for curbing inflation and revenue generation ways are likely to harm all - consumers, industry and services. I wonder if is it really worth attaching so much importance to the budget after seeing this budget? No bold step, only political compulsions written all over, leading us nowhere,â€? he said. According to him the biggest flaw is that the spending is â€œscattered and not likely to give any decisive improvement in any single areaâ€?. â€œOne of the most uninspiring budgets. Unsure strategies for curbing inflation and revenue generation ways are likely to harm all - consumers, industry and services. No bold step, only political compulsions written all over, leading us nowhere.â€? - Mr Supreet Deshpande, CEO, VLife Sciences Technologies Mr Deshpande also pointed out that the industry gets no incentive to produce more but customers have to pay more due to increase in excise. â€œAs a result of the increase in price, if consumption drops by two percent, even the government will get nothing more.â€? Same is the case with the services sector, he says. â€œWith an increase of two percent of service tax, the only gainer is the government,â€? he remarked, adding â€œnothing for my sector, except continuation of 200 percent deduction on R&D expensesâ€?. Dr Shama Bhat, chairman & managing director, Bhat Bio-tech India, too found the budget a total disappointment and said there is nothing in it to encourage the industry, particularly the biotech industry. â€œThe increase in excise duty will be a total disappointment. Already, we have a very high tax system, which puts our products at a cost disadvantage against other countries such as China,â€? said Dr Bhat. He, however, has a word of praise too. â€œSetting up of the India Opportunities Fund is good and will help new entrepreneurs,â€? he says, while pointing out that the much-awaited relief on raw materials import for the diagnostic industry still did not materialize.â€? Mr Pawan Chaudhary, chairman & managing director (CMD), Venus Remedies remarked that most of the pharma companies have their subsidiaries or arms overseas and are subject to international tax. â€œThe positive stance shown by the Finance Minister on Advance Pricing Mechanism is encouraging and would certainly help the industry. Pharma sector is also facing a challenge in having talented manpower. Additional incentive announced on account of weighted deduction on skill development will go a long way in helping the sector,â€? he said, while pointing out that increase in both excise duty and service tax would result in additional burden. Dr Ajaykumar Sharma, practice head â€“ Pharma, Healthcare Practice, Frost & Sullivan, South Asia & Middle East, said there are two aspects to the budget. â€œOne is for the rural populace, which seems to have been positively benefited from the budget. However, for the second, urban populace, there has hardly been any impact. For the industry as a whole, the budget seems to be in line with their expectation of increase in service and excise tax structure.â€? Mr Apurva Shah, chairman of Association of Clinical Research Organization (ACRO) India, found Budget 2012 a halfhearted effort to promote R&D. Commenting on the government's proposal to extend weighted deduction of 200 percent for R&D expenditure, he said, â€œWe had expected the government to recognize that CROs account for an important component of R&D and, therefore, the R&D set off should be spread to cover R&D done outside pharma companies in CROs. By doing so, it would speed up the R&D process and position India as a leader in pharmaceutical R&D.â€? Mr Shah praised the fund set aside for training and hoped that these funds can be availed to train professionals to conduct ethical clinical research as per Good Clinical Practice. Some provisions in the agriculture sector received a thumbs up from Mr D Narain, India Region Lead â€“ Monsanto. â€œThe budget proposals for 2012-13 are positive and progressive and they should help generate farmer-led inclusive growth in the agriculture sector. The provision of a weighted deduction of 150 percent on expenditure incurred for agri-extension services will facilitate growth in the sector. With this all stakeholders engaged in extension of research will be encouraged to invest in the upgradation of cultivation or agricultural practices for improved returns to the farmers. Similarly, an increased allocation of funds to state agricultural universities will enhance the level of research currently underway,â€? he said. Mr Narain further said given the challenge of water scarcity, the focus on micro-irrigation and drip irrigation schemes with allocation of 14,242 crore is a big step forward and, if implemented well, it will give a fillip to the yield and increase farm incomes. â€œWhile we are hopeful that the measures announced by the Finance Minister will give much needed boost to the agricultural sector, concerted efforts will be required towards sustained policy support, economic incentives and clear regulatory framework to achieve the desired growth rate in agriculture and make Indian agriculture globally competitive,â€? he added. Mr K V Balasubramaniam, MD, Indian Immunologicals, said he was disappointed that there was no relief granted as weighted deduction for outsourced R&D and clinical trials or lower duty on R&D and testing equipment. â€œOn the other hand, with excise on finished vaccines increased from one to two percent and without the Cenvat setoffs, hike in exicise duty on raw materials from 10 to 12 percent (similar impact on imports from higher CVD), and the service tax hike, our input costs will rise. This will squeeze our already thin margins,â€? said Mr Balasubramaniam. â€œHowever, with better outlays for health, especially for achieving the targeted 100 percent vaccination coverage, as the Finance Minister said in his speech, and also higher outlays for the Rashtriya Kisan Vikas Yojana, which covers the animal health sector, we expect better business opportunities for our human and animal vaccines.â€? Dr Rajesh Jain, joint managing director, Panacea Biotec, terming Budget 2012-13 as a balanced budget. â€œIt is not very encouraging as far as the pharma sector is concerned. The government's plan to set up an integrated vaccine unit at Chennai in south India will affect the private players in vaccine industry. A two percent increase in basic excise duty rate from 10 percent and service tax increase from 10 to 12 percent will affect profitability. There is no mention about the weighted tax deduction on clinical trials outside approved R&D center, tax exemption on pediatric medicines and tax exemption on new hospitals,â€? he said. Sharing the same views, Dr Vinay Konaje, founder and director, Navya Biologicals, said, â€œOverall, budget is balanced, keeping in mind the hostile political environment, with focus on infrastructure development. As for its impact on an R&D company like Navya, there is no impact of the budget, either positive or negative, on our operations. Not specifying an early time line for implementation of Goods and Services Tax (GST) is a negative.â€? Sharing his thoughts, Mr Rajen Padukone, CEO, Manipal Hospitals, pointed out that the Prime Minister's promise to increase spend on public health to reach 2.5 percent of GDP in the next five years does not reflect in the budget. To reach that number, expenditure should more than double in five years whereas the budget provides only 15 percent increase. Mr Daara Patel, secretary-general, Indian Drug Manufacturers' Association, said the Union Budget was not very exciting for the pharma industry. â€œWe are afraid that it is going to be difficult for the companies to maintain the price line as excise duty on bulk drugs has gone up from 10 to 12 percent and for formulations, from five to six percent. Also, increase in service tax from 10 to 12 percent is further going to affect the cost of medicines,â€? he said. Terming the budget as another bitter pill for the life sciences industry, Mr Hitesh Sharma, National Leader & Tax Expert - Life Sciences, Ernst & Young, said, â€œContrary to the expectations of the industry, there is no major incentive or reform for life sciences industry. For an industry already reeling under pricing controls and competition, general increase in service tax and excise duty from 10 to 12 percent is likely to increase both input and output costs further. A five-year extension for 200 percent weighted deduction for in-house R&D, increased deduction to 150 percent of capital expenditure incurred for hospitals and deduction of 5,000 for preventive health check-up are positives for the industry, but with limited impact. List of drugs and medical devices eligible for lower import duty and excise duty exemption expanded to include additional life science drugs.â€? â€œWhile a slew of amendments in transfer pricing and international tax side likely to impact companies across the board, including pharmaceutical companies, introduction of Advance Pricing Agreements (APAs) is a welcome move, â€œ added Mr Rahul Patni, associate director, Life Sciences, Ernst & Young. On the policy side, Mr Hitesh Sharma said, â€œThe government has continued its focus on augmenting healthcare infrastructure and spends for masses by increasing allocation to various healthcare schemes, including the National Rural Health Mission (NRHM), by approximately 15 percent.â€? Managing Director of Advanced Enzyme Technologies, Mr C L Rathi, said he did not see any visionary movement in budget. â€œBiotechnology is not much on government agenda. The last state elections have their mark on the current government.â€? Mr Krishna Prasad, managing director, Granules India, commented that the budget was in line with expectations, given the current political atmosphere. â€œThe government missed an opportunity to improve the country's fiscal health by not reducing subsidies. Instead of directing new revenue into programs that offer short-term benefits and hurt the country over the long-term, it would have been prudent to hold on to the revenue to demonstrate the government is serious about reducing fiscal deficit or at the very least, invest in capital expenditures, which will benefit the country and ultimately improve growth rate,â€? he said. According to Dr Kiran Mazumdar-Shaw of Biocon, with this Budget, the government had an opportunity to take decisive strides in the direction of socio-economic progress, â€œbut sadly it remains inert. It is time to remember that actions speak louder than rhetoricâ€?, he said. ]]> <![CDATA[A deal undone: Biocon, Pfizer go back on alliance]]> https://biospectrumindia.com/news/95/1468/a-deal-undone-biocon-pfizer-go-back-on-alliance.html https://biospectrumindia.com/news/95/1468/a-deal-undone-biocon-pfizer-go-back-on-alliance.html Tue, 10 Apr 2012 10:19:00 +0530 Ending of the 1,750 crore ($350 million) partnership with Pfizer means the Indian biotechnology major, Biocon, will have to find new partners to realize its growth plans. Pfizer too will have to find new avenues to mitigate its revenue drop due to patent expiration IIt was a path-breaking deal that had many eye balls rolling. Industry soothsayers predicted it to be the beginning of an exponential growth for the biotech industry in India. The landmark 1,750 crore ($350 million) deal inked between global pharmaceutical player Pfizer and India's top biotechnology company Biocon, signed on October 2010, was viewed as a catalyst bolstering confidence of multinational firms in Indian companies, which could spur more such R&D collaborations in the future. According to the strategic deal, Pfizer had to pay $200 million for exclusive rights to globally commercialize several of Biocon's insulin products - Recombinant Human Insulin, Glargine, and Lispro. Biocon was to receive an additional payment of $150 million from Pfizer towards further development of drugs and to meet regulatory milestones. Biocon was also to receive payment linked with Pfizer's sale of the insulin products. A win-win situation for both parties, bringing together Pfizer's strong marketing and commercialization capabilities, especially in the highly regulated developed markets of the world, and Biocon's expertise in biotech R&D. The insulin products were slated to roll out in the emerging markets by 2011, followed by Europe and the US in 2012 and 2015, respectively. While the reasons for calling off the deal is yet to be revealed, both companies mentioned that their individual priorities for their respective biosimilars businesses propelled them to move forward independently. As of March 12, 2012, all rights licensed to Pfizer will revert to Biocon, and all insulin distributed under the brand names Univia and Glarvia will be commercially available from Biocon only, and will be exclusively manufactured, supplied, marketed and supported by Biocon. Also, Biocon would retain the upfront payment of $100 million and also the $100 million that Pfizer paid as an escrow account for Biocon to develop insulin products. It will, however, have to forgo the $150 million that it would have received from Pfizer for further developments and meeting regulatory milestones. Biocon witnessed a sharp fall in licensing income in the third quarter ending December 2011 from the exceptional levels recorded last fiscal, which resulted in flat earnings overall. Commenting on the fall, Ms Kiran Mazumdar-Shaw, CMD, Biocon, said licensing income is a timing issue and subject to periodic variability. The impact Financially, the termination will not impact Biocon that has retained $200 million in its kitty that, market analysts predict, could be used for R&D investments. â€œBiocon's products are yet to be rolled out and commercialized in the developed and emerging markets. Hence, financially the impact would be minimal,â€? says Mr Sudarshan Padmanabhan, research analyst, Prabhudas Lilladher, an India-based financial services group. In fact, some experts also opined that the amount was significant enough for Biocon to set up its own facility, though the company would any day opt for a strategic alliance. Lessons from partnerships The shelving of the Biocon-Pfizer deal can be a huge learning for companies seeking growth through partnerships at a time when an impending patent cliff is putting pressure on the revenues of big pharmaceutical companies and the Asia Pacific region is emerging as the favored destination for drug discovery and manufacturing to counter high costs of R&D and manufacturing. A representative from Genentech, says, â€œMishaps happen when interests clash. In this case, it is assumed that the priorities of Pfizer had changed because the cost advantage went lower than their expectation, and they did not see much profitability in this partnership.â€? Pharmaceutical companies have two ways of entering into partnerships. It can be a business model for cost advantage that can be done through outsourcing or it can be a partnership for innovation. For instance, if an MNC is looking to leverage the benefits of the China market, outsourcing could be the most viable option. However, a long-term partnership is the right way for innovation. â€œSpecialty drugs and biosimilars are new avenues that have high profitability in the long run and partnering in these innovative areas can be viable opportunity for both the parties. However, the opportunities are very big and the challenges are highly complex,â€? pointed out Ms Kiran Mazumdar Shaw, CMD, Biocon. She was speaking at the two-day BioPharma Asia convention held in Singapore on March 20, 2012. The need to maintain marketing control can often restrict the choices available for strategic partnership, added Ms Shaw. â€œAlso the need to explore products from a therapeutic perspective influences the choice of partner. The parties need to identify the requirements and then move ahead.â€? At a recently held biosciences conference organized by BioSpectrum in Singapore, Ms Cheryl McCaffery, deputy director, Industry Development Group, A*Star, Singapore, spoke about the various sides of collaborations. She mentioned that in the process of selecting a partner, a research company should understand the structure of the industry trends and niche areas where the technology could be applied. â€œOne should analyze the strengths and weaknesses of the partner and then begin courting,â€? she said. Amrita Tejasvi in Singapore From a market perspective, it is definitely a blow for Biocon as the company will again need to scout for a partner with a strong presence in the insulin market, both in the developed and emerging markets of the world. Pfizer proved to be an ideal strategic fit towards this goal. â€œPfizer has a strong marketing presence in regulated markets such as the US and Europe. Pfizer would have given Biocon the opportunity to access such markets where the insulin market is huge,â€? says Mr Ranjit Kapadia, vice president, Centrum Capital, India. Scouting for an apt partner who could give access to these highly regulated markets would be a time-consuming process for Biocon. Dr Ajaykumar Sharma, practice head â€“ Pharma, Healthcare Practice, South Asia & Middle East, Frost and Sullivan, agrees on this. â€œIn the short term, Biocon will have to continue with regional partners and look forward to expanding its core business. This means some growth plans will have to take a back seat. In the long run, it will continue its growth by pushing into other biosimilars areas that the company is currently not serving,â€? he says. Mr Ranjit Kapadia of Centrum Capitals says the challenge for Biocon will be to look for a partner who is equal to or better than Pfizer. â€œOr it can invest in setting up its own facility with the money that it has in hand. But the fact remains that both are time-consuming processes,â€? he adds. Divesting its 70 per cent stake in its German arm, Axicorp GmbH, post the global alliance with Pfizer could be a missed opportunity for Biocon. â€œIf Biocon had retained its stake in its German arm, Axicorp would perhaps have given Biocon access to the EU market today,â€? points out Mr Kapadia. For Pfizer too, the deal termination could prove to be a setback. The company is already reeling under the pressure of a sharp drop in revenues post the patent expiration of a slew of its blockbuster products starting 2012. It is exploring profit-making avenues to make up for this loss. Biosimilars is one such growth area, and a deal with Biocon would have given the company access to the burgeoning global insulin market. Insulin is a $14 billion global market and, by 2015, a number of insulin analogs will be out of patent protection, resulting in a significant opportunity for biosimilars. â€œFor Pfizer, it means looking at other areas of investment to make up for the loss of revenues due to some key drugs going off patent between 2010 and 2020,â€? adds Dr Ajaykumar Sharma of Frost & Sullivan. The company has already reported a drop in its fourth quarter (Q4 2011) revenues due to expiration of patent of Lipitor, one of its biggest drugs. The Q4 2011 revenues were $16.7 billion, a decrease of four percent from $17.4 billion for the same period a year ago. Expiry of patent for its next big product, Viagra, too will be a big revenue dampener in the coming year. Against such a backdrop, business in biosimilars and generics through partnerships could help mitigate its anticipated drop in revenues. There are mixed opinions over whether this would impact Biocon's prospective partnerships with global drug giants and whether it has affected the global community's confidence in Indian companies. â€œThere will be some dent in the trust factor. But Biocon as a brand is strong enough to tide over this scenario. They already have many regional partners and will continue to do their business,â€? says Mr Kapil Khandelwal, director, Makven Capital, while pointing out that every partnership deal goes through extensive scientific, commercial and market due diligence with milestones clearly articulated. â€œHence, if any deal goes through or fails, it is dependent on its merits and achievement of milestones and not on the overall corporate performance. Biocon's future partnerships with MNCs will be based on the diligence of the research milestones and future potential of the product. Current termination will not have any impact on the future partnerships,â€? he remarks. Regardless of the consequences of this deal annulment, MNCs are here to stay in India. â€œAt the end of the day, India is a big market for MNCs and they will never think of restricting themselves from striking collaborations with Indian companies and investing in the country,â€? adds Mr Sudarshan Padmanabhan of Prabhudas Lilladher. The question remains as to who could be Biocon's next prospective commercialization partner who could give the former the same bandwidth as Pfizer. â€œNovo-Nordisk, Eli-Lilly and Sanofi Aventis are the leading names in the insulin market. Biocon can look at these partners,â€? says Mr Kapadia of Centrum Capitals. â€œWe remain committed to delivering our biosimilars insulins portfolio to global markets in our endeavor to make a difference to diabetic patients across emerging and developed economies. We will continue to work with our existing partners in several markets and will pursue a commercial strategy on our own and through new alliances in other markets.â€? - Ms Kiran Mazumdar-Shaw, CMD, Biocon â€œWe continue to be dedicated to developing a broad portfolio of biosimilars medicines, including monoclonal antibodies and recombinant protein products, both internally and through collaborations. In addition, we will continue to be active in our own research and business development efforts for diabetes, which represents a huge unmet medical need, and we remain committed to seeking new solutions to help physicians and patients.â€? - Diem Nguyen, general manager- Biosimilars, Pfizer How hot is biosimilars? Biosimilars was slated as the hot segment for investment by Indian companies. Yet it has not taken off the way it was predicted two years ago. â€œIndian companies are yet to grapple with the fact that biosimilars is a different ball game than small molecules. There is no room for short cuts in biosimilars research. The research is complex and investments in time and money are huge. Also, marketing them in markets such as the EU and the US require strict adherence to quality standards,â€? says an industry expert who did not want to be named. Dr Ajaykumar Sharma of Frost & Sullivan has a similar view. â€œCost of development coupled with huge marketing costs has restricted biosimilars drugs to very few niche areas, such as diabetes, oncology and rheumatology. The highest selling segment in India is still the anti-infectives and cough and cold therapies that were launched almost 20 years ago. Biosimilars need to go beyond the current areas it is serving to make a real dent in the market,â€? he says. Mr Kapil Khandelwal of Makven Capital says that this has been a matter of debate and discussions at many industry forums. â€œThis can be looked at from three angles: One is that many Indian players have experimented on different business models. Some have succeeded, some have partially succeeded, and others have failed. We have not analyzed the reasons for the failures or partial successes and learnt from them. Secondly, pharma companies in emerging markets need leaders to address issues in the region. There is a leadership failure in getting the direction right. Lastly, in terms of regulations, we are just not attractive enough as compared to the emerging markets of China and Korea,â€? he points out. Mr Sudershan Padmanabhan of Prabhudas Lilladhar points out that even globally, biosimilars has not really taken off. â€œApart from complexity in research, even in terms of regulations, in the US itself there is no pathway for biosimilars. The EU has one but that too is not clear. Once these markets open up, it could prove to be favorable for India.â€? Nayantara Som Banerjee in Mumbai ]]> <![CDATA['We provide services to 14 of the top 20 pharma companies']]> https://biospectrumindia.com/news/95/2419/we-provide-services-to-14-of-the-top-20-pharma-companies.html https://biospectrumindia.com/news/95/2419/we-provide-services-to-14-of-the-top-20-pharma-companies.html Tue, 10 Apr 2012 10:17:00 +0530 Mr Swapan Bhattacharya,MD,TCG Life Sciences Innovative partnership is a key element for CROs to sustain the rapid changes in the pharma industry. TCG Life Sciences (TCGLS), a leading contract research services, clinical research, and laboratory informatics company with operations in India, Europe, Japan, Australia and the US, offers a unique mode, which it has built on its strengths and forged strategic partnerships that has helped it essay the role of a partner rather than just a service provider. Kolkata-based TCGLS, which has a strength of almost 1,000 employees across three divisions of Chembiotek (discovery research), Clininvent (clinical research and development) and Labvantage (enterprise informatics), recently delivered on one such partnership with Pfizer, in February 2012, and with Endo pharmaceuticals, in January 2012. Mr Swapan Bhattacharya, MD, TCG Life Sciences, who has been with the company for over 14 years, speaks to BioSpectrum about these successful partnerships and what differentiates the firm from other CROs. Q Can you tell us about the partnership with Pfizer? Mr Bhattacharya: We have had collaborations with Pfizer for over nine years. When they first came to India, they were looking to partner with different CROs. Over the years, they have consolidated a list of CROs and, at this point, we are the only CRO that is providing chemistry and discovery services to Pfizer in India. In 2009 we signed an agreement, which changed the mode of operations, where our relationship transformed into a more strategic one. We were given the opportunity to not only work on more targets and be more proactive in designing the program, but also contribute from our side in terms of risk taking, which was termed as integrated drug development project. Today, we have a pre-clinical development candidate ready, as per the agreement. Q Can you elaborate on your collabration with Endo Pharmaceuticals? Mr Bhattacharya: In a span of less than two years, we developed a pre-clinical drug candidate for long-term post operative care for Endo through an interesting partnership. Another program involving the development of a first-in-class drug, whose first phase was completed in less than the allocated time, is also showing a lot of potential. We hope to finish this project soon. Instead of building the infrastructure for discovery operations, Endo is using CROs in partnership. They are managing the program and we are carrying out all the work. It is a very synergistic way of working as we are both working on our strengths. The rights for exploiting the intellectual property (IP) is owned completely by the client. Actually we got the contract for the second program, while we were still doing the first one. I think this is because we try to creatively eliminate the impediments in drug discovery early on. The programs are controlled by a joint steering committee that has an equal representation of people from both the organizations. So this is less of a service and more of a collaboration. We look at it like a partnership. Q What is the business model of TCGLS? Mr Bhattacharya: We have tried to create an integrated chain at TCGLS. We believe that activities that can be done together and can help create synergy should be done under one roof. For example, if you are doing drug discovery, you would want various factors from IP search to look at different libraries for a target, including absorption, distribution, metabolism, and excretion (ADME) screening and would ultimately want the disease modelling to be done at the same location. This process works most efficiently if it is in one place. We have exploited that, and this is the competence that is seen in our work with different partners. We have certified good manufacturing practices (cGMP) facilities, which allow us to develop compounds that can be taken for first-in-man studies. Also, in an integrated drug discovery chain, the value of the molecule goes up as the molecule moves further into the pre-clinical stages. It makes sense to get the molecule to a higher level to get its full value. Q How would you describe your client base? Mr Bhattacharya: If you consider all the three businesses together (Chembiotek, Clininvent and Labvantage), we provide services to 14 of the top 20 pharma companies. It's a fairly good mix of big and specialty pharma and biotechs, with big pharma constituting more than 50 percent. All our clients are from outside India, with most of them being repeat clients. Rarely have we had a client who went away unsatisfied. Q How is the reduced spending by big pharma affecting your operations? Mr Bhattacharya: In the short term, it is a challenge. When a company undergoes major restructuring, people lose focus on the externalized research and that poses a problem for CROs. However, at the end of the day, health challenges will remain. There will always be a need for research. The last few years have been very challenging, but with time, we are growing. Ultimately, we are service providers in an industry that is undergoing rapid changes. Unless we change too and add value to what we are bringing to the table, it will be very difficult. Q With most biotech companies concentrated in small pockets in the country, do you face any difficulties being based in Kolkata? Mr Bhattacharya: We do have offices in different cities including Mumbai, Delhi and Pune, but we are primarily based in Kolkata. Since our parent company, The Chatterjee Group, was based in Kolkata, we grew from there. The only difficulty was that Kolkata was not exactly on the global map when pharma companies came scouting for partners. They would usually not make that additional two-hour trip, which was a challenge. However, now we see that because of our location, we are different from other CROs. We have less attrition and also very good academic resources. We routinely do work in other cities according to the customer's needs. Q What do you think sets TCGLS apart? Mr Bhattacharya: We are very strong in library synthesis, chemistry and biology. We look at things from a drug discovery point-of-view, rather than a services point-of-view. I think our biggest strength would be our people, who have had considerable experience in the industry and have the ability to work alongside other companies. We have had a very negligible attrition rate in our organization, especially in senior management. Our distinction has been our interest in innovation, early involvement in biology, and ability to take molecules from small scale to large scale. These are the areas where we seem to have an edge over others. Q What are your future plans? Mr Bhattacharya: We are clearly defined as an early discovery company, which comprises everything that takes place before clinical trials. We think that if regulatory mechanisms permit us, then we can conduct phase I trials and develop the candidate till proof-of-concept and thus increase the value of the product. Right now, the pre clinical candidtates are handed over to other CROs for further studies. We want to leverage on that aspect and grow in that area as well. In chemistry, as we move forward we want to get bigger. Right now we can provide supplies till first-in-man studies in phase IIA. To do the larger studies like phase III, we would need more capacity and that is something we would be looking at. Manasi Vaidya in Bangalore ]]> <![CDATA[India's Nexavar licensing creates a global debate]]> https://biospectrumindia.com/news/95/1643/indias-nexavar-licensing-creates-a-global-debate.html https://biospectrumindia.com/news/95/1643/indias-nexavar-licensing-creates-a-global-debate.html Tue, 10 Apr 2012 10:15:00 +0530 Till early March, Nexavar, the brand name of the blockbuster anti-liver cancer drug, sorafenib, sold by Bayer in India in tiny quantities was an unknown commodity. An Indian patient with advanced liver cancer paid 280,000 for a dose of 120 tablets he has to take in a month or spend close to 35 lakh in a year for the drug which could extend life by six-to-10 months. It is not difficult to guess how many of India's estimated 29,000 liver cancer patients could afford to benefit from this biotech wonder drug, developed by a small company, Onyx Pharmaceuticals, in Emeryville, California. Bayer bought the key protein invented by Onyx and developed it into the liver cancer drug. Nexavar became a blockbuster with $1 billion in sales in 2011 for Bayer. The revenue growth was seven percent over the 2010 sales of $934 million. But all that changed on March 13, 2012, when India's Patent Office granted a request from Hyderabad-based Natco Pharma to compulsorily make Bayer's patented drug and make it available at 97 percent discounted price of 8,800 for a month's dose. Of course, Bayer will get a six percent royalty on Nexavar's sales by Natco. Predictably, the pharma industry around the world has raised a storm of protest. The US government officially expressed its displeasure at the Indian Patent Office's decision on Nexavar. â€œIs intellectual property safe in India?â€? was the headline in a US pharma magazine. India's biotech industry association, ABLE, too has issued a strong protest against the government's move, saying the compulsory licensing of Nexavar will hit innovation in the country. There are over 600,000 people with the advanced condition of liver cancer who can benefit from Nexavar treatment. Bayer's sales figures for 2011 indicate that with differentiated lower prices in some patients, just a tenth of the potential beneficiaries actually had access to the drug. Globally and in India, the biotech industry has been championing the cause of affordable drugs through innovation. And the biotech industry has always projected the image of a patient-friendly sector striving to help patients in need all over the world. And this image has earned the industry a high public profile. So, is the compulsory licensing of Nexavar a bad idea? After all, the Indian government has only used an option available to it under the global trade provisions. If governments such as India can't use these provisions to increase availability of a key medical product, what is the use of such a facility, ask many health activists. There is a fear that India may set a trend and the Nexavar decision will be followed by more such compulsory licensing of other drugs patented in the country since 2005. There is no evidence to show that such a trend may be set. After all, this is the first case of compulsory licensing by the country after adopting the new intellectual property regime. It will certainly help if India's health administrators explain the rationale for the decision on Nexavar and also present the plight of these 29,000 liver cancer patients in the country that convinced the government to take such a decision. Such a step will certainly help calm the industry and also provide some clues to the future decisions on several applications for compulsory licensing pending with Indian Patent office. The biotech industry should demand a position paper on Nexavar and compulsory licensing from the government immediately. Narayanan Suresh Chief Editor sureshn@cybermedia.co.in ]]> <![CDATA[India allows compulsory licensing of Bayer]]> https://biospectrumindia.com/news/95/6562/india-allows-compulsory-licensing-of-bayer.html https://biospectrumindia.com/news/95/6562/india-allows-compulsory-licensing-of-bayer.html Mon, 09 Apr 2012 17:18:00 +0530 The decision is likely to open up the field for the generics industry or force innovative companies to make drugs more affordable. But will it also affect innovation? BioSpectrum explores the two sides of the story The globally watched case related to an Indian pharma company's request to the country's patent office for a compulsory license to make a generic version of Bayer's patented drug to treat liver and kidney cancer has been settled on March 13, 2012. In a first-of-its-kind ruling in one of the world's fastest growing pharma makets, the Indian Patent Office has granted permission to pharma company NATCO to make anti-cancer drug sorafenib for the India market. The Indian Patent Office's ruling is subject to certain conditions, such as maintaining account of sales, and payment of royalty at six percent of the net sales on a quarterly basis to Bayer. The order also makes it obligatory for NATCO to supply the drug free-of-cost to at least 600 needy and deserving patients per year. Immediate beneficiaries will be the 29,000 patients suffering from liver and kidney cancer who could not afford treatment with Nexavar, which was patented by Bayer in India in 2008. Bayer sold the drug for approximately $5,714 for a month's dosage of 120 tablets. The average annual income of an Indian is approximately $6,000. Under the compulsory license, NATCO will make a generic version of the drug in India and has been directed to sell it at $180 for a month's dosage, a cost which is 32 times less than that of the original drug. Hailing this order, NATCO opined that this opens up a new avenue of availability of life-saving drugs at an affordable price to the suffering masses in India. Reacting to this, Mr Rahul Dev, managing partner, Tech Corp Legal, India, said, â€œThis has opened up the field for the generic industry to follow suit and could well pave the way for the availability of cheaper drugs for lifestyle diseases. We are likely to see a significant shake out and consolidation in the near future. More generic companies could invoke the compulsory licensing clause of the Indian Patents Act, following the said decision to allow NATCO Pharma to sell a generic version of Bayer's patented anti-cancer drug (Nexavar) at 97 percent reduction.â€? He says the landmark judgment by the Indian Patent Office is now being seen as a test case and it is almost certain that Bayer will go to court on this issue. Bayer had contested the Indian company's application for compulsory licensing. NATCO Pharma, based in Hyderabad, insisted that Bayer was not providing the benefits of its patented medicine by making it available to the needy Indian patients at a reasonable cost. India's Patent Office evaluated Bayer's costing mechanism, which was reasoned to be the cause for prohibitively expensive cost in the India market. The drug itself had fast track approval in the US after it was classified as an â€œorphan drugâ€? required for some diseases, which did not have an attractive market. The Indian Patent Office then invoked the provisions of the Trade Related aspects of Intellectual Property Rights (TRIPS) of the World Trade Organization (WTO) and granted compulsory licensing as a requirement for public health. Three years ago, Thailand first tested this TRIPS provision by allowing production of a generic version of an anti-cholesterol drug. The Indian Patent Office's decision on Nexavar has been watched with interest around the world. This decision on Nexavar is going to create heated debate about the requirements of needy patients and the patenting aspects once again globally. The pharma industry, which has invested millions of dollars to produce such innovative drugs, is certainly not happy with India's decision. The Association of Biotechnology Led Enterprises (ABLE), a national forum that represents the $4 billion biotechnology industry in India, reacted sharply to grant of a compulsory license to NATCO Pharma. A statement by ABLE says compulsory licenses should be used only when there is a national health crisis or when life-saving drugs are priced out of the reach of the common man, in other words under some exceptional circumstances. The organization further noted that governments are likely to interfere under such circumstances, like when a few countries invoked this provision for making available life-saving HIV drugs to its people. India should always keep in mind that a compulsory license should not be invoked in an arbitrary manner as it will undermine the innovative efforts of this industry and consequently invest in this sector, it said. Most multinational and Indian pharma companies spend millions of dollars and many manhours to save patients from life threatening diseases and, therefore, the intent of all these companies broadly is to alleviate suffering of people. However, at times, overseas companies price their drug based on who they think can purchase and do not take into account the millions who could be deprived of a treatment due to affordability. ABLE pointed out that Nexavar is an orphan drug in the US and not approved by National Institute for Health and Clinical Excellence (NICE) for National Health Service's use in view of the fact that it increases survival in primary liver cancer by only six months. While on pricing when it is obvious that there is a case on the overall utility of this drug which prolongs life by half-a-year, the question is why should India invoke compulsory licensing in the case of Nexavar? Raising concerns, the biotech industry forum says, â€œThis is a question that will come up for considerable debate as to whether it is really a true life-saving classification. In future, before such rulings are invoked it might be a good idea to debate on the cost of goods versus the cost of innovation. If we put in mechanisms to compensate the companies which do innovation, then the severity of such rulings will be quite considerably mitigated.â€? There is going to be demand from health activists and generic pharma makers to seek more such compulsory licenses on essential drugs, which were patented after 1995 under the TRIPS agreement in many developing countries. The Nexavar test case has indicated that the patent holder of vital drugs will be subjected to more scrutiny by major stakeholders of the public health system in the coming months. The patent holder will be forced to act on their patents to benefit people rather than use the rights to price such products out of the reach of the thousands of patients who could potentially benefit from such innovations. The pharma industry will have to come up with suitable mechanisms to avoid more requests of compulsory licensing and avoid a public relations disaster by seeming to act in a way to reap undue benefits at the cost of needy patients. What use is an innovative drug, if it can't help to cure patients who need it the most, will be the question that will reverberate in communities around the world after this Indian decision on Nexavar. ABLE expressed its concerns by pointing out that the momentum and global image of India's focus on innovation might be at risk, at a time when the Indian government has declared this as the â€œDecade of Innovationâ€?. Narayanan Suresh in Bangalore (With inputs from Narayan Kulkarni) ]]> <![CDATA[Hyderabad plays host to Industry Interaction]]> https://biospectrumindia.com/news/95/2483/hyderabad-plays-host-to-industry-interaction.html https://biospectrumindia.com/news/95/2483/hyderabad-plays-host-to-industry-interaction.html Thu, 08 Mar 2012 18:20:00 +0530 Delegates visiting the interactive exhibitors section, which saw participation from different companies across countries, such as Korea and Sri Lanka. With a view to optimize opportunities in bio businesses worldwide, BioAsia 2012, held from February 9-11, 2012, at the Hyderabad International Convention Center in Hyderabad, provided a platform for facilitating partnerships and networking between different Asian companies. The event saw participation from around 600 delegates from 40 countries, including the US, Korea, Belgium, Germany, Iran, Singapore, Nepal and Africa. BioAsia 2012 not only allowed for comprehensive interactions through an international buyer-seller meet, which saw participation from 45 sponsored international buyers from 17 countries, but also facilitated in-depth discussion of the current trends in the biotech industry across Asia. There were many interesting aspects to the event this year. A Power 20 Breakfast meeting with Dr Seth Berkley, chief executive officer, GAVI Alliance (Global Alliance for Vaccines and Immunisation), provided industry leaders an opportunity to discuss matters of grave importance. Dr Seth Berkley was also the recepient of the Genome Valley Excellence Award for his commitment to the betterment of human health as a physician, epidemiologist and for being a leading advocate in public health and vaccines. The Genome Valley Excellence Award was also awarded to Merck, US, for its commitment to patient health and vaccine research and was received by Mr Kevin Ali, president of the firm's emerging markets. The Federation of Asian Biotech Association Special Award was given to Mr Cyrus Mistry, deputy chairman and chairman-designate of the Tata Group, for his relentless efforts in establishing the SP Biotech Park (now Alexandria Knowledge Park) at Hyderabad, which in many ways paved the way for the rise of the Genome Valley. The BioAsia Special Award was given to Mr Karun Rishi, president, USâ€“India Chamber of Commerce. One of the new features of the event this year were the workshops that were held in collaboration with educational institutes. This attracted a lot of attention from students and academicians alike. Vaccine policy in India With Hyderabad being an important seat of discovery and manufacturing in India for vaccines that are supplied the world over, it was only apt that a special focus be given to the vaccine industry at this congregation of industry experts from the world over. Although Indian vaccine companies supply over 40 percent of the world's vaccines, lack of political will has resulted in India having very low immunization rates. Discussion on the Indian National Vaccine Policy provided much fodder for thought in this context. Dr P V Appaji, CEO, Pharmexcil (left), in coversation with Dr Krishna Ella, CMD, Bharat Biotech, and Dr Rajesh Jain, JMD, Panacea Biotec. Dr Berkeley emphasized the need to formulate strategies in order to implement the recommendations of the policy. â€œIndian companies have made great progress in the last few years in providing vaccines worldwide. However, the recent WHO delisting of a few companies can affect the overall image of the quality offered by Indian companies. The challenge in the vaccine industry today is how to take quality seriously. A strong national regulatory body is needed that can make the standards for domestic as well as international use, strong,â€? he said. Dr Nata Menabde, WHO representative desginate to India, said, â€œThere is a great lesson to be learnt from the success of the polio immunization drive in India. With no live case being detected in over a year, vaccination campaigns like that for polio have only re-emphasized the need for sustained surveillance by the country. The National Vaccine Policy of India is a positive sign but a clear indication of how the policy will be implemented is also necessary for it to have a true impact.â€? Dr Seth Berkley, CEO, GAVI, receiving the Genome Valley Excellence Award from Mr Kiran Kumar Reddy, Chief Minister, Andhra Pradesh Innovative business models for CROs In view of big pharma cutting down on R&D spendings, local CROs across Asia are looking to form strategic partnerships that can help them progress. Mr C S N Murthy, CEO, Aurigene Discovery Technologies, elaborated on this when he said, â€œBig pharma would be looking to cut down on their early phase development budgets due to the expected losses that they will face once the patents of their blockbuster drugs start to expire. At such a time, CROs need to reinvent themselves and find innovative models to sustain themselves rather than just rely on traditional models and build on their individual strengths.â€? India vs China With major MNCs such as Quintiles, Merck and AstraZeneca having announced major investments at their facilities in China during the last one year, a raging debate amongst those gathered at BioAsia 2012 seemed to center around the growing investments in the Chinese biotech industry. Industry experts from diverse backgrounds, such as investment banking, biotechnology, local vaccine industries, CROs and pharma majors were of the opinion that the Chinese government showed its support to the life sciences industry through various initiatives, which attracted them to invest in China. Dr Krishna Ella, chairman, Bharat Biotech, opines, â€œGlobally, the Indian vaccine industry is recognized for making path breaking achievements. Regulatory challenges are making it difficult for Indian companies, but since India is an emerging economy, things like regulation will take time. Although India supplies over 40 percent of the world's vaccines worldwide, lack of political will has resulted in India having very low immunization rates. The Chinese government has been very supportive of the Chinese vaccine industry. The government purchases almost all of the vaccines produced by the firms. The Indian government needs to show similar support.â€? Mr Kewal Handa, MD, Pfizer India, provided the perspective of a leading MNC when he said, â€œChina provides a competitive price, domestic attractiveness and most importantly, a clear regulatory mechanism. All these factors provide a very attractive package for MNCs to invest in China.â€? Mr Hasit Joshipuria, VP, South Asia and MD, GSK India, echoed this sentiment. â€œAs health is a central as well as a state subject in India, a lot of regulatory mechanisms for introducing new vaccines are not clear,â€? he says. Dr Wenyong Wang, MD, merchant and investment banking, Burril & Company, presented a different perspective to this debate when he said, â€œThe biologics and vaccine industry started more than two decades ago in China and hence is more mature than India. The drive for newer vaccines and biologics is very strong in China, which is leading to a lot of innovation. Also, the Chinese and Japanese governments are very supportive of their biotech industry and this helps accelerate development.â€? BioAsia 2012 allowed delegates from 40 different countries to meet and get a chance to interact. Many were also of the opinion that India has a very strong base by establishing current good manufacturing practices (cGMP) qualified manufacturing plants for the production of biologics. Notwithstanding the regulatory hurdles, the industry in India made a lot of progress and carries the potential to do so in the future as well. The general sentiment echoed by all those who were present was that the time is ripe to accelerate development in the biotech industry in India along with government support. Manasi Vaidya in Hyderabad ]]> <![CDATA[Eisai knowledge center wins award]]> https://biospectrumindia.com/news/95/2471/eisai-knowledge-center-wins-award.html https://biospectrumindia.com/news/95/2471/eisai-knowledge-center-wins-award.html Thu, 08 Mar 2012 18:17:00 +0530 Eisai Pharmatechnology and Manufacturing was selected as a category winner for the Facility of the Year Awards in the project execution category among a group of 20 state-of-the-art projects that were constructed in 10 different countries. Now entering its ninth year, the â€œFacility of the Year Awardsâ€? program is the global pharmaceutical industry's premier awards program that recognizes state-of-the-art pharmaceutical manufacturing projects that utilize new and innovative technologies to enhance the delivery of a quality project as well as reduce the cost of producing high-quality medicines. With the above, Eisai Vizag has become the first facility of the country to have achieved this prestigious award. In addition to the manufacturing of APIs and formulations of its major products such as Aricept, Eisai is conducting API process research and manufacturing of API and formulations of the company's global products. Novozymes to collaborate with Sea6 Novozymes entered an exploratory research agreement with Sea6 Energy, an India-based company, to jointly develop a process for the production of biofuels from seaweed. The research alliance will use enzymes to convert seaweed-based carbohydrates to sugar, which can then be fermented to produce ethanol for fuel, fine chemicals, proteins for food and fertilizers for plants. Novozymes will research, develop, and manufacture enzymes for the conversion process, while Sea6 Energy will contribute its offshore seaweed cultivation technology. Sea6 Energy has already developed ocean-farming structures that are robust and versatile compared to traditional methods of seaweed cultivation. These structures could be used to create large-scale seaweed farms in offshore locations. In addition, Sea6 Energy is also pioneering approaches to fermenting the sugars derived from seaweed to produce fuel in a manner that requires minimal use of fresh water resources. Sea6 Energy is currently trying out its cultivation technology in partnership with a few fishing communities around the coastal areas of South India. Novozymes' Indian arm will work closely with Sea6 Energy to develop the conversion technology. New Monsanto breeding station in Bangalore Monsanto India, a subsidiary of the Monsanto Company, US, and the only publicly listed Monsanto entity outside the US, inaugurated their state-of-the-art breeding station for developing and testing new varieties of hybrid corn and vegetable seeds in Karnataka. Spread across 117 acres at Kallinayakanahalli in Chikkaballapur district, 55 km from Bangalore, the breeding station has been established with an investment of 25 crore from Monsanto. The new facility was inaugurated by Mr D Narain, region lead, Monsanto India, Mr Amitabh Jaipuria, MD, Monsanto India, and Dr Robert de la Pena, Asia vegetable R&D lead, Monsanto Singapore. The breeding station will focus on developing high-yielding hybrid seeds for corn, tomato, cabbage, cauliflower, cucumber and watermelon cultivation mainly for farmers in southern India. Ranbaxy files consent decree Ranbaxy Laboratories filed a consent decree with the US FDA on December 20, 2011, with the US District Court for the District of Maryland. Under the terms of the consent decree, which is subject to approval by the court, Ranbaxy has committed to further strengthen procedures and policies to ensure data integrity and to comply with current good manufacturing practices. â€œThe announcement is the next step in the process of finalizing our agreement with the FDA to resolve this legacy issue,â€? said Mr Arun Sawhney, Ranbaxy CEO and MD. â€œAll of our efforts are focused on continuing to provide safe, effective and affordable products to consumers around the world,â€? he said. GSK net sales up 15.4 percent GlaxoSmithKline Pharmaceuticals recently showed a 15.4 percent growth in net sales in its financial results for the fourth quarter ending December 31, 2011. The core pharmaceuticals business grew by 18.2 percent for the quarter. For the year ended December 31, 2011, the growth in net sales was 10.7 percent and profit after tax and before exceptional items was 8.6 percent while the core pharmaceuticals business grew by 12.5 percent. The quarter saw the launch of Synflorix, a vaccine against invasive pneumococcal disease, and branded generics in the metabolic and Steifel range of products. In 2011, the company also expanded its oncology portfolio by launching Votrient, indicated for the treatment of RCC and Revolade for the treatment of ITP. ]]> <![CDATA[India to control FMD in cattle]]> https://biospectrumindia.com/news/95/2021/india-to-control-fmd-in-cattle.html https://biospectrumindia.com/news/95/2021/india-to-control-fmd-in-cattle.html Thu, 08 Mar 2012 18:14:00 +0530 India is committed to control foot and mouth disease (FMD) in cattle to increase the productivity of the livestock sector. Stating this at the inaugural session of three-day International Conference on Scientific Developments and Technical Challenges in the Progressive Control of Foot and Mouth Disease (FMD), in New Delhi, Mr Harish Rawat, minister of State for Agriculture and Food Processing Industries, said controlling the disease will help improve the livelihood of small, marginal and resource poor farmers. The minister said that for ensuring the maintenance of disease free status, and to be compatible with the international standards, major health schemes have been initiated to support animal health programs in the states. In order to control the economically important livestock diseases, and to undertake the obligatory functions, related to animal health in the country, the central government is implementing various schemes to control these diseases, Mr Rawat added. Noida authority to set up biotech park A project for setting up a world-class biotech park at Greater Noida has been initiated recently by the Greater Noida Authority. The park is proposed to be spread across 100 acres and would cost around `31 crore. According to the authority, the park will primarily promote projects in healthcare, industrial biotechnology and agricultural biotechnology in the areas of manufacturing as well as research. It will consist of a technology incubator to enable the technopreneurs to develop commercially viable technologies and will have laboratory spaces with all the utilities like gas connection, power and water among others. The tenants will also have access to various common facilities like animal house, green house and common cold storage facility. A bonded warehouse has also been conceived. The park is expected to provide access to some of the India's major research institutes like AIIMS, Center for Biotechnology, National Brain Research Center, ICGEB, Tata Energy Research Institute, IIT-Delhi and the Indian Agricultural Research Institute among others. Green signal for national policy on NDPS The Union Cabinet approved the national policy on Narcotic Drugs and Psychotropic Substances (NDPS) drafted by the Ministry of Finance, Department of Revenue, in consultation with the concerned ministries and agencies of the government and the state governments. The objective of this policy is to keep an eye on legal production, manufacturing, trade and use of NDPS for medical and scientific uses and to maintain balance between supply and demand ratio. The policy attempts to curb the menace of drug abuse and contains provisions for treatment, rehabilitation and social re-integration of victims of drug abuse. Implementation of the provisions of the policy will lead to reduction of crime, improvement in public health and uplifting of the social milieu. The NDPS policy will serve as a guide to various ministries and organizations and re-assert India's commitment to combat drug menace in a holistic manner. PPP for inculsive growth in agriculture Globally, there is an increased interest in agricultural research and development because of the food concerns around the globe and escalating food prices. There is a need for consolidation of research programs, development of a long-term human resources plan and public-private partnership to ascertain inclusive growth in agriculture, said Mr Sharad Pawar, minister of Agriculture and Food Processing Industries, Governement of India. Speaking at the annual conference of vice chancellors of agricultural universities and the Indian Council of Agricultural Research (ICAR) directors held in New Delhi, Mr Sharad Pawar said the ICAR institutes and state agricultural universities must reinforce the interface mechanism to improve synergy in order to minimize duplication of efforts and lead to judicious use of resources. Mr Pawar called for a demand driven approach to research and development of synergies both between the researchers and between the researcher and the end user. He asked the vice-chancellors who are training the future researchers to see that this aspect of agricultural research is internalized in our students. Conversations should involve a broad array of stakeholders with an interest in undergraduate agriculture education. The minister pointed out that ICAR is devising innovative programs to improve the technology delivery and agricultural education with enhanced emphasis. This would greatly improve the entrepreneurial skills of the agricultural graduates, the minister added. ]]> <![CDATA[TCG achieves key milestones]]> https://biospectrumindia.com/news/95/1603/tcg-achieves-key-milestones.html https://biospectrumindia.com/news/95/1603/tcg-achieves-key-milestones.html Thu, 08 Mar 2012 18:12:00 +0530 TCG Lifesciences (TCGLS) achieved two distinct milestones in their ongoing drug discovery partnership with Endo Pharmaceuticals. TCGLS will receive undisclosed success fees against these milestones. In the first of the two fully integrated discovery programs with Endo aimed at identifying novel small molecule drug candidates for an unmet medical need, TCGLS has successfully delivered a pre-clinical development candidate. Two lead molecules resulting from this collaboration have been selected by Endo for cGMP manufacturing and GLP-toxicology studies. In the second of the two fully integrated discovery programs with Endo, initiated in 2011, TCGLS has designed and delivered novel fast-follower hit structures well within collaboration timelines. This multi-year, three-stage project aims to identify potent in-vivo active novel blockers of an undisclosed target for eventual clinical development. Additionally, TCGLS also announced the nomination of a pre-clinical development candidate under an R&D collaboration entered into in 2009 with Pfizer. As per the agreement, Pfizer will own the candidate and other back up candidates, while TCGLS will receive a milestone payment for its success in moving these molecules to the candidate stage. TCGLS' participation encompasses synthetic chemistry, in-vitro pharmacology, DMPK, in-vivo pharmacology, and preliminary safety. Early-stage milestone for Jubilant Jubilant Biosys, a Bangalore-based subsidiary of Jubilant Life Sciences, achieved an early-stage milestone in one of their collaborative programs with US-based Endo Pharmaceuticals that has nominated a candidate into full development. The novel molecule targeting cancer is anticipated to go for clinical trials by late 2012. Jubilant and Endo Pharmaceuticals will continue the collaboration in the development phase as well. The multi-target collaboration that began three years ago focuses on best-in-class differentiated therapies to address the unmet needs of cancer patients worldwide. The collaboration has since delivered multiple milestones across the discovery phase. Endo will pursue development and commercialization of the compound, while Jubilant becomes eligible to receive development milestones. Astellas renews license for GOSTAR Astellas Pharma has extended and renewed its license for the GVK BIO SAR databases (GOSTAR). GVK BIO Online Structure Activity Relationship (SAR) (GOSTAR) Database is an online scientific database product of GVK BIO. It integrates information on compounds from discovery & development stages and marketed drugs. Information provided includes SAR, ADME, toxicity, preclinical, clinical and structural data for over 5.1 million compounds and 16.7 million SAR points. Advinus, Celgene collaborate Advinus Therapeutics, an emerging drug discovery and development company, has initiated of a discovery and development collaboration with Celgene Global Health. The collaboration, which has been agreed upon for an initial term of 18 months, will focus on therapies for visceral leishmaniasis (VL), the second-largest parasitic killer in the world with an estimated 500,000 cases each year. Recent estimates show that more than 90 percent of cases occur in India, Bangladesh, Nepal, Brazil and Sudan. The collaboration has been formed to specifically address unmet patient needs as current treatments have significant drawbacks, including route of administration, length of treatment (21 to 28 days), and emerging parasitic resistance. The goal of the project is to identify and develop compounds that are safe and effective against VL parasites. Brookfield inaugurates lab in India US-based laboratory Brookfield Engineering Laboratories inaugurated its first application lab in India powered by Amkette Analytics (of the ANM alliance group). This is the company's first application lab in the whole of South East Asia. This was inaugurated in Mumbai by Mr David Brookfield, president and CEO of Brookfield Engineering Labs, USA. The laboratory will look at services like after-sales support, demonstrations, maintainence and will also be a nodal point where customers from different regions in Asia can bring in samples for testing. ]]> <![CDATA[Making their mark on life sciences]]> https://biospectrumindia.com/news/95/1849/making-their-mark-on-life-sciences.html https://biospectrumindia.com/news/95/1849/making-their-mark-on-life-sciences.html Thu, 08 Mar 2012 18:11:00 +0530 BioSpectrum in this series features scientists from the life sciences sector in India, whose research and implementation of strategic ideas have made significant contributions not only to the research units of their organizations but also to the world Dr Rajesh Gokhale, director, Institute of Genomics and Integrative Biology (IGIB), has been working on an innovative molecule that hits all four of the TB bacterium's crucial metabolic pathways at the same time, thus weakening and ultimately destroying the pathogen. Dr Cyrus Karkaria, president, biotech division, Lupin Phama India, is looking to leverage his knowledge and expertise in drug development and commercialization, which he obtained from his past experience in the US, in order to leave a mark in the global biosimilars space. Dr Anish Sen Majumdar, CSO, Stempeutics, who has extensive R&D experience spanning more than 19 years, particularly in the field of mesenchymal stem cells, is leading Stempeutics to conduct the first-of-its-kind clinical trials in India for its product Stempeucel for various disorders such as COPD and osteoarthritis. ]]> <![CDATA[Pioneering research in stem cells]]> https://biospectrumindia.com/news/95/4868/pioneering-research-in-stem-cells.html https://biospectrumindia.com/news/95/4868/pioneering-research-in-stem-cells.html Thu, 08 Mar 2012 18:10:00 +0530 Dr Anish Sen Majumdar CSO, Stempeutics Despite being a biochemist by training, Dr Anish Sen Majumdar is a formidable authority in the cutting-edge field of stem cell research due to his experience, spanning more than 19 years with more than 60 publications in peer reviewed journals and 10-to-15 patents for processes regarding the isolation and characterization of stem cells. Currently, the CSO at Stempeutics, one of India's leading companies dealing with stem cell-based therapies, Dr Majumdar has been leading the process of obtaining permission for and conducting path breaking trials for stem cell therapies using mesenchymal stem cells. Born in Aizwal, the capital of Mizoram, Dr Majumdar had his primary education in different parts of the country. After his Masters in Biochemistry, due to an interest in immunology, Dr Majumdar decided to study the immunological aspects of cholera as a part of his PhD thesis at the University of Calcutta. He then pursued his post doctoral research at the University of Pennsylvania, which involved studying cell response to various growth factors. During this period he was successful in isolating a new growth factor from human placenta. Dr Majumdar adds, â€œFrom that point onward, I was very curious about how a cell responds to growth factors. At the same time, since I had a good background in immunology, I was lucky enough to be able to do another post doctoral fellowship at Stanford University under, Dr Irving Weissman, who was the first to isolate and characterize mouse hematopoetic stem cells from the bone marrow. There I worked on mouse mesenchymal stem cells and the differentiation of committed progenitor cells that give rise to T cells.â€? On completing his second post doctoral fellowship, Dr Majumdar started his journey in the industry with companies such as Becton Dickinson, Geneic Sciences and later Rhone-Poulenc (now Aventis). He got an opportunity to work on stem cells when he joined Geron in 1998. At Geron, he rose from the position of a group leader to senior director of immunology and cell therapy over the course of 10 years. Working at a leading stem cell company like Geron allowed Dr Majumdar to lead important projects, such as developing a vaccine for cancer using telomerase technology and using embryonic stem cells for therapy in conditions like diabetes. The exciting developments in India in the field of stem cells soon beckoned in the form of an offer to head the division for stem cell research at Reliance Life Sciences (RLS) in India, where his team successfully developed three new stem cell lines. Dr Majumdar's work at Stempeutics too revolves around adult mesenchymal stem cells. Dr Majumdar adds, â€œMesenchymal stem cells are non immunogenic, that is these can be derived from one person and will not cause an immune response if injected into another. Also they secrete necessary growth factors.â€? Under Dr Majumdar's guidance, Stempeutics is now conducting the first-of-its-kind clinical trials in India for its product, Stempeucel, for various disorders such as chronic obstructive pulmonary disorder and osteoarthritis (critical limb ischemia and acute myocardial infection). Of these, Dr Majumdar informs that trials for osteoarthritis are being simultaneously conducted in Malaysia as well as in India and will hopefully be completed by the end of this year, allowing for a launch of the product by 2014. Furthermore, for autologous treatments, the research team at Stempeutics is also working on a device that could automate the process of autologous stem cell transplants and bring it to the clinic rather than processing the samples at the labs along with other projects involving stromal vascular cells fraction for cosmetic treatments. Dr Majumdar adds that he is very hopeful that these technologies will be available to the Indian public in the coming years. Manasi Vaidya in Bangalore ]]> <![CDATA[On the biosimilars mission]]> https://biospectrumindia.com/news/95/1363/on-the-biosimilars-mission.html https://biospectrumindia.com/news/95/1363/on-the-biosimilars-mission.html Thu, 08 Mar 2012 18:08:00 +0530 Dr Cyrus Karkaria president, biotech division, Lupin Pharma India Dr Cyrus Karkaria, president, biotech division, Lupin Pharma India, has brought on board a wealth of knowledge and expertise in drug development and commercialization from his past experience in the US. He hopes to replicate the same success in Lupin's biotech endeavours. Lupin Pharma, which boasts of an illustrious history in the field of small molecules, is determined to etch a mark in the global biosimilar space. The biotech team headed by Dr Cyrus Karkaria, president, biotech, Lupin India, has left no stone unturned in translating this vision into a reality. Dr Karkaria is highly optimistic, while giving his observations on the Indian biotechnology industry. â€œI am excited to be in India. The global market for biosimilars is $120 billion and emerging markets contribute to about one-fifth of that market. Out of that, around 10 percent is India's contribution. So India's contribution by 2015 is going to be $2 billion and this is huge.â€? Having completed his Masters in Biochemistry from the University of Mumbai, in 1984, he left for the US to pursue his PhD in biochemistry from the University of Maryland and subsequently did his post doctoral fellowship from the Harvard Medical School. In 1992, he went on to work for a start-up company, Scios, which gave him a good footing in biotechnology research. Having worked for two years there, he went on to join another start-up company that looked into protein chemistry. He later joined Biogen Idec, which was the high-point in his career. For eight years, he was part of drug development and commercialization of the company's various products, like its multiple sclerosis product Avonex, which went on to become a blockbuster drug. He also looked into the commercialization of other multi-billion dollar drugs like Amevive and Tysabri. â€œI have achieved many accomplishments in the past, in terms of publications and patents, but the achievement of being part of the team that commercialized a drug called Avonex has been a major milestone for me,â€? he says. Following this, Dr Karkaria joined a genomics-based company before choosing to come back to India in 2010 and joining Lupin Pharma. â€œI felt that it was the perfect time to come back. The biotechnology industry in India is in a nascent state and the forecast is that it is bound to grow fast in the coming years. I want to be a part of the India growth story.â€? On joining Lupin, Dr Karkaria was given a straight forward plan by the management to replicate their success in the small molecules generics space in biotechnology. â€œMy core mandate here is to develop biosimilars for the developed markets. We are constantly evaluating opportunities and are looking at new biological entities (NBEs) and biobetters,â€? he adds. Lupin's first biological product for oncology will be commercialized this year. The team expects this product to contribute five percent of its global revenues by 2015. â€œWe have finished the trials and now it is a question of filing reports and getting the marketing team organized,â€? he informs. â€œOur strategy is straightforward. We want to commercialize a particular set of biosimilars for select markets and after that we will look at biobetters or even NBEs. Our main priority now is to focus on biosimilars,â€? he says. India is going through exciting times, he adds. Given its present strength, it is bound to lead in the global landscape in the coming years. â€œIndia has strong points to take the lead. I see that a lot of individuals are coming back to India and setting up small start-up companies. The trend is bound to catch up in the next 10 years. Moreover, the Department of Biotechnology has been very proactive in providing funds to small biotech companies,â€? he concludes. This can go a long way in adding to India's innovation story. Nayantara Som in Mumbai ]]> <![CDATA[Targeting four pathways of TB]]> https://biospectrumindia.com/news/95/1030/targeting-four-pathways-of-tb.html https://biospectrumindia.com/news/95/1030/targeting-four-pathways-of-tb.html Thu, 08 Mar 2012 18:05:00 +0530 Dr Rajesh Gokhale director, Institute of Genomics and Integrative Biology, New Delhi As one of the youngest directors of any research institute in India, Dr Rajesh Gokhale took the initiative of addressing the research deficit in few of the key areas. Challenging the one disease, one drug, one target paradigm, which is dominant in the pharmaceutical industry, Dr Gokhale has been working on an innovative molecule that hits all four of the TB bacterium's crucial metabolic pathways at the same time, weakening and ultimately destroying the pathogen. Setting a new example, Dr Gokhale besides holding the position of director at the Institute of Genomics and Integrative Biology (ICGEB) in New Delhi is also a co-founder of Vyome Biosciences and serves on the board of directors and scientific advisory board of the firms. Dr Rajesh Gokhale completed his doctorate at the Indian Institute of Science, Bangalore, while working on protein folding under the guidance of Professor P Balaram in 1996. Thereafter, he went abroad to work as a postdoctoral fellow in Dr Chaitan Khosla's laboratory at the chemical engineering department of Stanford University. There he investigated the catalytic mechanisms of modular mega-synthases, such as polyketide synthases. After a distinguished three-and-a-half year stint, he returned to India to pursue research in neglected tropical diseases. He joined the National Institute of Immunology (NII), New Delhi, and continued with his research for 10 years on Mycobacterium tuberculosis. His research group sought to dissect the molecular mechanisms that generate functional diversity through 'enzymatic crosstalk' and thus provide insight into mechanisms employed by pathogens to generate metabolite diversity. During this research, Dr Gokhale was able to find out that Mycobacterium does not produce any secondary metabolites, but makes complex lipids essential for its growth. Dr Gokhale became a senior research fellow of the Wellcome Trust International Senior Research Fellowship in 2001. In 2003, he was awarded the B M Birla Science Prize. His work was duly recognized in 2006, when he was awarded the Shanti Swaroop Bhatnagar Prize in Biological Sciences. He has published over 40 papers in leading journals, such as Nature, Nature Chemical Biology, Proceedings of the National Academy of Sciences and Molecular Cell. He has been an honorary faculty member of the Jawaharlal Nehru Center for Advanced Scientific Research, Bangalore, and a Fellow of the Indian Academy of Sciences. â€œScience is not an easy job and requires a lot of focus. Thanks to my stint at Stanford, I learnt to think from a different perspective. Deep inside, I always wanted to apply the research outcomes to some beneficial purpose,â€? says Dr Gokhale. At present, Dr Rajesh Gokhale's group is working to understand how metabolic networks are elaborately tuned in nature in three different model systems; is investigating the role of polyketide-synthases in understanding the complex differentiation process of dictyostelium; and is also working on the biochemical mechanisms underlying melanocyte-keratinocyte interactions in context of vitiligo, a disease that hasn't been given due importance so far by researchers in India. At New Delhi-based Vyome Biosciences, Dr Gokhale is playing the role of a mentor and guide to researchers, giving them new ideas to work upon. Dr Gokhale says, â€œWe found out that the dermatophytes don't make fatty acids and instead release lipases. Within the next six months, the new innovative product may be launched after undergoing toxicological studies.â€? Although dissatisfied with the lack of innovation in the industry, Dr Gokhale believes that research institutes and private companies through joint efforts can play a significant role in changing the scenario. Highly optimistic about the future, Dr Gokhale says, â€œThere is a lot of positivity in the country. The next 10 years are expected to be a decade of major opportunities for the biopharma industry.â€? Rahul Koul in New Delhi ]]> <![CDATA[PPP: Bioenergy for the future]]> https://biospectrumindia.com/news/95/1990/ppp-bioenergy-for-the-future.html https://biospectrumindia.com/news/95/1990/ppp-bioenergy-for-the-future.html Thu, 08 Mar 2012 17:10:00 +0530 In this month's public-private partnership (PPP) series, BioSpectrum focuses on the bioenergy sector - showcasing the three case studies that can make a huge impact in fulfilling our future energy requirements Bharat Petroleum and TERI are working on a joint project on butanol production from lignocellulosic biomass. The project is supported by BIPP. Avesthagen is working on production of bioethanol products from self glucogenic pearl millet. This project is also supported by BIPP. SPC Biotech is validating its technology to convert agricultural waste from mango kernel into bio-plastic. This project is supported by the DBT. ]]> <![CDATA[Mission: Pearl millet biomass transformation]]> https://biospectrumindia.com/news/95/2150/mission-pearl-millet-biomass-transformation.html https://biospectrumindia.com/news/95/2150/mission-pearl-millet-biomass-transformation.html Thu, 08 Mar 2012 17:05:00 +0530 Funding from the Department of Biotechnology served as a great boost to Avesthagen's unique project that focuses on developing pearl millet as an alternative for the biofuel industry Food sources such as maize and sorghum are often used to produce biofuels. However, these are extensively used as edible food substances, making them a non-viable option for the production of biofuels in the long run. In order to tackle this problem, Bangalore-based Avesthagen decided to use pearl millet, a hardy local crop grown in marginal land, for the biofuel industry. The company utilized its patent position on cellulases and xylanases and combined it with its patented Triple Star technology to develop a package that generated the pearl millet transformation patent. The uniqueness of this technology is that it doesn't interfere with the food and separates the requirement of material for both food and biofuel industry. The project conceived by Dr Villoo Morawala Patell, founder and CMD Avesthagen, was initiated in 2009. The objective was to develop pearl millet transgenics that are endogenously adapted to yield high biomass under both drought and saline conditions, using Avesthagen's proprietary Triple Star technology and vacuolar-localized glycolases for self-degradation after harvest of grain. It received a Biotechnology Industry Partnership Programme funding of `1.5 crore. Part of it was in the form of a grant and the remaining was a soft loan. The remaining cost, which was equivalent to 1.5 crore, was shared by the company. However, after isolating all the cellulose and xylene-digesting enzymes from diatoms, the challenge was to make these enzymes thermo active (80oC) so that the plants harboring these enzymes would not have adverse effect on their growth. Moreover, the other challenge was to store these enzymes in a proper place in the plant for later utilization. The R&D team adopted a systems biology approach, made the cellulose digesting enzymes thermostable and stored them in vivo in vacuoles of the plant cell for further utilization. Talking about the importance of the BIPP funding, Dr Morawala-Patell says, â€œBIPP is critical for this kind of capital-intensive and robust ideas to see the light of the day. Traditionally, financial institutions are comfortable funding well-established companies but are quite wary of funding early-stage R&D. Moreover, if the biotech industry has to sustain its innovation quotient during early stage R&D, SMEs need to be encouraged and funded by the government.â€? The way forward Currently, all the glycolases genes have been identified and the research team at Avesthagen is in the process of generating self-glucogenic pearl millet transgenics. In future, it is expected that the transgenic lines would express glycolases and store these enzymes in the vacuole, an abundant organelle in drought stressed plants. This strategy will sequester the hydrolytic enzymes from the cellulose fibril polymerizing machinery and protect the plant from auto-degradation during the growth and maturation of the crop. After harvest and threshing of the grain, the crop residue will be homogenized to release the enzymes from the peroxisome. It is expected that this technology would digest the crop residue without further addition of cellulose digesting enzymes, using minimal resources that may be implemented at the level of the farm. Dr Patell says, â€œSelf glucogenic pearl millet and the harboring technology will significantly reduce the external enzyme requirement. Increased biomass will be utilized for the biofuel industry whereas the increased grain yield due to Triple Star will help the food industry. Farmers will be greatly benefited by the incremental revenue that the self glucogenic technology would yield.â€? Rahul Koul in New Delhi ]]> <![CDATA[Mission: Butanol from sugarcane bagasse]]> https://biospectrumindia.com/news/95/2382/mission-butanol-from-sugarcane-bagasse.html https://biospectrumindia.com/news/95/2382/mission-butanol-from-sugarcane-bagasse.html Thu, 08 Mar 2012 17:03:00 +0530 New Delhi-based The Energy and Resources Institute and Bharat Petroleum are executing a unique joint project on butanol production from lignocellulosic biomass of abundant sugarcane waste In the recent past, lignocellulosic biomass gained substantial attention as feedstock for production of biofuelsas it is renewable and inexpensive energy source. Moreover, the accumulation of lignocellulosic wastes in vast quantity also poses environmental problems. Therefore, the sugarcane bagasse that are rich in lignocellulosic biomass and available in vast amount in India can serve as potential feedstock for ethanol and butanol production. Considering the fact that around 300 million ton of sugarcane are is produced by India per annum, the proposal on production of butanol from sugarcane bagasse was initiated jointly by The Eneregy Research Institute (TERI) and Bharat Petroleum. Aimed at developing microbial-based technology for biobutanol production, the collaborative project received the Biotechnology Industry Partnership Programme (BIPP) funding of around 48 lakh from the Department of Biotechnology (DBT), Ministry of Sciences and Technology, Government of India. At present, TERI is involved in the saccharification of C6 fermentable sugars from lignocellulosic biomass and co-fermentation of C5 and C6 sugars for enhancement of butanol yield efficiency. In this context, enzymatic hydrolysis of lignocellulosic biomass by cellulase and hemicellulase enzymes offers promising approach because of their moderate operating conditions, higher conversion efficiencies, high sugar yield and lower environmental impact. Specific microorganisms belonging to the group of bacteria and fungi have got unique capability of producing these enzymes. According to Dr Banwari Lal, director, environmental and industrial biotechnology division, TERI says, â€œThis project is aimed to study the process for butanol production from sugarcane bagasse by simultaneous saccharification and co-fermentation through the employment of robust microbes having potential saccharification of cellulose and hemicellulose. Specific milestones include optimization of process parameters for maximization of C5 and C6 fermentable sugar recovery by selected robust microbes including optimization of process parameters for co-fermentation of C5 and C6 sugars to maximize butanol yield from sugarcane bagasse.â€? The way forward The potential advantages of butanol such as lower vapor pressure, higher energy density, lower water solubility, less corrosiveness and easy addition to gasoline than ethanol, gained global attention for use as a possible gasoline blendstock and an alternative to ethanol. The project has been successful in identifying robust microbes, which can efficiently accomplish the enzymatic saccharification of lignocellulosic biomass at mild conditions. Currently, research work is in progress to optimize the process parameters to increase C5 and C6 sugar recovery as well as to enhance the butanol yield efficiency. Dr Lal says, â€œThis project is quite promising for us and holds importance as it deals with gaining insight into the enzymatic saccharification of recalcitrant lignocellulose biomass for C5 and C6 fermentable sugar recovery. It serves as a suitable cost effective feedstock for butanol fermentation.â€? Rahul Koul in New Delhi ]]> <![CDATA['The QC market is where the money lies']]> https://biospectrumindia.com/news/95/1524/the-qc-market-is-where-the-money-lies.html https://biospectrumindia.com/news/95/1524/the-qc-market-is-where-the-money-lies.html Thu, 08 Mar 2012 17:00:00 +0530 Mr David Brookfield president & CEO, Brookfield Engineering Labs Mr Sanjay Mehta co-founder, Amkette Analytics US-based Brookfield Engineering Laboratories inaugurated its first advanced application lab in Mumbai, supported by its dealer in India Amkette Analytics (part of the ANM Alliance group). The facility is Brookfield's first application lab in South East Asia and will help the company's customers in India with application support and product demonstrations. The lab will also cater to regions in West Asia, Africa and the Association of South East Asian Nations (ASEAN) as a knowledge resource center for viscosity, rheology and powder flow analysis. While speaking to BioSpectrum, Mr David Brookfield, president and CEO of Brookfield Engineering Labs, US, and Mr Sanjay Mehta, owner of ANM Alliance and co-founder of Amkette Analytics, gave their points-of-view as a principal and a distributor, respectively. QThis is Brookfield's first advanced application lab in South East Asia. Why did you choose India?  Mr Brookfield:   India is a very important market, and a fast-growing strong economy. Today, the country has a 10 percent share in Brookfield's total global revenue. The country has the potential for increased volumes and the demand for high-end applications is huge. We work closely with our dealers while setting up our facilities. Fortunately for us, Amkette (who have been our distributors in India) has been forward-thinking and customer-oriented enough to set up this advanced application lab. The purpose of the lab is to conduct upfront testing in order to show the customers the benefits of setting up such a laboratory. Looking forward, we hope that in the coming years, Brookfield, along with its dealers, will set up similar centers in other parts of Asia. QWhat is that one opportunity in India that Brookfield wishes to cash upon?  Mr Brookfield:   Although India is an important market, the R&D domain is relatively small here. The quality control (QC) market is where the money lies because if you do not have QC testing, which is accurate and reliable, then the customers will lose millions of dollars. In QC, if you do not follow the right procedure then you get a product that the customers do not accept. QWhat steps and initiatives did Amkette take while setting up this lab?  Mr Brookfield:   We are an instrumentation company and we have been in this business in India since 1967. This application lab is a value-added service that we are offering to customers. Over the years, we have observed that new technologies that are in vogue in the industry are rheometers and powder flow measurements. These are state-of-the-art technologies that are not available everywhere and work out to be expensive for customers. This application lab is a solution for them. Now they do not have to invest in this technology by themselves. Also, we have got our people trained by experts from Brookfield Engineering Laboratories, who developed this technology. QWhat investments, in terms of money and equipments, have been made in this application facility?  Mr Brookfield:   We have invested about a quarter million dollars in this lab that includes a range of instruments. The purpose of this lab is also to provide training to students from pharmacy colleges and even industries, who want to send their freshers for training on our instruments. Amkette will expand its lab, which will include instruments like gas chromatographyâ€“mass spectrometry (GCMS) and liquid chromatographyâ€“mass spectrometry (LCMS), and will be the company's service to customers. From Brookfield's side, the investment into this application lab has been in providing process viscometers, rheometers and powder flow testers among others. QWhat are the challenges faced while convincing Indian customers to take state-of-the-art equipment like viscometers and rheometers?  Mr Brookfield:   For viscometers, we do not face much challenges but we do face challenges for rheometers and powder flow measurements. These are high-end machines and I feel that it will take time for the machine to get accepted in the QC stream, which is the main market for us. The good news is that R&D labs will now start using these technologies. Once this is set, the demand and volume will definitely catch up with viscometers and then people will start using these technologies for QC too. QSince 2008, the global market has been going through ups and downs. Did that affect businesses for Amkette and Brookfield?  Mr Brookfield:   We did not experience any downturn until 2009, when we did experience a slowdown. However having said that, we still had a strong year. This is because of our presence in the global QC market, which is a high-volume domain and this factor will keep us strong and will keep us going even when the market (which now) is very weak.  Mr Mehta:   Since 2008 until date, the world has seen a slowdown but we at Amkette worked hard to secure a huge growth. We had to work three times more. Now, even the debt crisis in EU will not affect us because science is ever expanding and there are new discoveries everyday and for new discoveries you need new technologies. QIs Brookfield looking at dealing with customers directly and establish an active presence?  Mr Brookfield:   We are definitely looking at emerging markets, but in India we will continue to work through Amkette due to their strong presence in the market and they will continue to serve our customers. This is our long term plan for the future. Brookfield does have a representative office in India but that looks after at the overall business in Africa, Middle East and Asia. Nayantara Som in Mumbai ]]> <![CDATA['We are looking at acquisitions, partnerships and global networking']]> https://biospectrumindia.com/news/95/1211/we-are-looking-at-acquisitions-partnerships-and-global-networking.html https://biospectrumindia.com/news/95/1211/we-are-looking-at-acquisitions-partnerships-and-global-networking.html Thu, 08 Mar 2012 16:55:00 +0530 Mr Sushil Karwa managing director, Krishidhan Group of Companies Jalna-based bio-agri company Krishidhan Seeds is aggressively rolling out its expansion plans that is expected to yield manifold results. Apart from a sky-rocketing surge in its biotech revenues and achieving a wider reach to Indian farmers, the company launched its global initiatives by setting shop in the burgeoning European market. Looking at its growth graph, Krishidhan has now set an ambitious target of hitting the 1,000 crore revenue by 2015 and is exploring newer geographies. In a conversation with BioSpectrum, Mr Sushil Karwa, managing director, Krishidhan Group of Companies, throws light on the company's strategy and its pursuit in leaving a mark in the Indian bio-agri industry. QKrishidhan Seeds saw a huge surge in its biotech revenues from 133 crore to 276.13 crore for the fiscal 2010-11. What were the reasons behind this tremendous growth?  Mr Karwa:   The company is determined to implement its model of the three Ps (planet, people and profit) in its international and domestic business. A team of high caliber and internationally experienced plant physiologist and breeders, molecular biologists, biotechnologists, entomologists and geneticists are the strengths of this company. Our team of scientists develop unique genetics that are rigorously tested in varied agro-climatic conditions, which in turn are integrated by arsenal of technologies with most precise molecular plant breeding tools and then considered for release in market. Furthermore, a dedicated workforce of 1,200 employees working panâ€“India are yet another asset of the company. Apart from the highly qualified scientists and technologists, Krishidhan also has a strong marketing network of over 490 personnel, spread across 22 of its sales offices. Moreover, the company has 1,600 distributors and over 25,000 retailers covering about 30,000 villages and reaching out to more than 6,00,000 farmers. The sales personnel and trade partners play a vital role. These are the reasons behind this tremendous growth. QWhat have been the achievements of Krishidhan Seeds in the current fiscal?  Mr Karwa:   With a turnover of around 313 crore, Bt cotton continues to be our core business, contributing significantly to our total revenue. We are working in all states and have launched stellar products for each zone of India. Krishidhan has special focus on Maharashtra as it contributes to 35 percent acreage of India, which makes it the biggest cotton seed market. Along with Maharashtra, Madhya Pradesh and Gujarat being adjacent and similar in agro-climate requirements, are other states where our Bt cotton hybrids have outperformed and enjoyed most preferred status in the market. In the north, because of our newly launched hybrid, â€œPanchamâ€?, we have received widespread acceptance by the farming community. Pancham has been developed by combining a package of technology to enable superior genetics integration suiting to northern zone dreaded diseases and pest resistance, and deep root characters that help establish with ease during prevalent stress conditions in Northern India. QWhat investments have the company made so far in R&D? Tell us about your research pipeline?  Mr Karwa:   Different processing modules are adapted for different crops and seasons, meeting stringent quality norms. Krishidhan is engaged in pioneering research through another group company Krishidhan Research Foundation (KRFPL). Collaborating with many national and international organizations, both in the public and the private sector, KRFPL is actively involved in several path-breaking projects related to resistance to insects and viruses, among others. We are also looking forward to the introduction of herbicide resistance in several crops, so that farm productivity does not suffer due to labor shortage. Our R&D biotech pipeline is preparing a novel technology enabled tool that would reduce biosafety concerns and will be able to lead better science-based public perception on GM technology, especially for food crops. We are looking forward to introduce a package of indigenous technology in crops like eggplant and maize. QGive a brief on Krishidhan Seeds' plans and investments in the GM food crop space?  Mr Karwa:  Krishidhan envisages to invest substantially in GM food crop development, however, our approach is towards developing and incubating indigenous technology that would have simple and significant science based benefits for consumers, farmers, public, environment and society. The company plans to invest in a cold storage, ultra-modern vegetable seeds processing plant, cotton plant for further capacity enhancement and automation processing plants. The next two-to-three years will propel the company's growth manifold. We are eyeing a turnover of around `1,000 crore by 2015 and plan to invest substantially in R&D. QKrishidhan Seeds has been aggressive in EU. How do these markets fit into Krishidhan Seeds' overall business strategy?  Mr Karwa:  India has a huge potential for farming and export of agro-products overseas. The agricultural exports have a crucial role to play in the long-term as it has the potential to provide farmers a better price for their produce. We have been field testing our products in Europe and have seen the potential they can offer in the developed world. This has been inspiring development to customize our processes and products for such a developed market with precision-driven expertise. QWill Krishidhan Seeds look at acquisitions abroad and in India? Is the company looking at other markets too, especially for its biotech business?  Mr Karwa:  We are definitely looking at acquisitions, partnerships and global networking. We are commercially exporting our products to the Middle East Asia, South Africa, Asia Pacific, Pakistan, Bangladesh, Sri Lanka and Europe. As and when we grow, we plan to tap more areas overseas. Biotech business is likely to expand, especially after a positive global growth in biotech crop hectares, which continues to climb after 15 consecutive years of strong growth. QBack in 2010, Summit Partners invested $30 million into the company. What is the progress so far?  Mr Karwa:  The investment comes at a time when many of Krishidhan Seeds's ambitious plans are unfolding at a breathtaking pace. The company needed infusion along with strategic professional direction to strategize its visionary plans. So we went in for PR investment rather than strategic partnership. Since then there has been no looking back for Krishidhan. Just after the fund infusion, Krishidhan moved overseas by beginning its operations in Holland. The venture, which is spearheaded by Krishidhan Seeds Europe and led by industry veteran Dr Jan Tamboer as its CEO, opens new vistas for the company to transform into a multinational seed company from a pan-India entity. QWhat are your observations on the performance of the Indian bio-agri industry in past one year?  Mr Karwa:  Agricultural biotechnology has unveiled immense opportunities for the Indian seed industry. Talking about the progress of Bt crop in India, its future is very bright. In India, farmers are in dire need for new technologies and new varieties of seeds. Bt cotton has changed the fortunes of the farmers and the economy at large. There is a 360 degree change with India turning into the second largest exporter of cotton from being an importer. Nayantara Som in Mumbai ]]> <![CDATA[Philanthropic funding to foster innovation]]> https://biospectrumindia.com/news/95/1309/philanthropic-funding-to-foster-innovation.html https://biospectrumindia.com/news/95/1309/philanthropic-funding-to-foster-innovation.html Thu, 08 Mar 2012 16:43:00 +0530 California-based philanthropic organization, Wadhwani Foundation, recently pledged a large amount of funding to IIT Bombay and NCBS, Bangalore, for research. While the industry has welcomed this initiative, it also points out the need for R&D funding from private organizations in India to foster an ecosystem of innovation Philanthropic funding towards academic research in India does not have an impressive track record. At least, not in biosciences research. High risks, large scale investments, long periods of gestation, high possibilities of failure, lack of transparency and accountability have caused many funding organizations to backtrack from their commitments. While this has definitely slackened the pace of biotech R&D in the country, it has to a large extent stunted any form of innovation stemming from the country's educational institutions. The only safe alternative for them is to resort to funds provided by government agencies and schemes, which again have their own set of obscurities. Against this backdrop, a recent initiative by the Wadhwani Foundation, headed by Dr Romesh Wadhwani, to infuse mammoth amounts of funding towards the setting up of state-of-the-art centers of research at the National Centre for Biological Sciences (NCBS), Bangalore, and the Indian Institute of Technology, Mumbai (IIT), have set many eyeballs rolling. Taking academia towards innovation A distinguished alumnus of IIT Bombay from the class of 1969 and an IT entrepreneur in Silicon Valley, California, Dr Wadhwani announced a gift of $5 million to his alma mater at a conference held in New York in July 2008. Today, through his foundation, he is determined to stimulate the system in India and create an energetic ecosystem for research. Speaking to BioSpectrum, Dr Wadhwani mentions, â€œIndia has immense talent pool but research output is not commensurate with world standards. The major reason I see behind this is lack of infrastructure and support to cultivate talent. For India to have a true powerhouse economy with sustainable eight-to-10 percent annual economic growth, it needs to be a global leader in innovation. This requires a commitment to world class research across a variety of industry segments. The funds that we are injecting into the system is to make the quality of research and infrastructure at par with global standards. The research happening in India today is not just boring but outright depressing whereas the talent pool in India is comparable to that anywhere in the world, if not better.â€? The Shanta Wadhwani Centre for Cardiac and Neural Research at NCBS in Bangalore and the Wadhwani Research Centre in Biosciences (WRCB) at IIT Bombay are part of the innovation initiative of the Wadhwani Foundation. It has pledged 32.5 crore in total, 7.5 crore to NCBS and 25 crore to IIT Bombay. â€œThe opportunities for innovation in India are very broad. And we have chosen biosciences and bioengineering as the initial focus,â€? says Dr Wadhwani. While the Shanta Wadhwani Centre will look at research into regenerative biology, the WRCB in Mumbai will look at the science of cancer growth, mainly cell motility and cancer invasion using emerging technologies. Speaking to BioSpectrum, Prof Devang Khakhar, director, IIT Bombay, says, â€œThis is going to be a major center for IITB. We are already getting a lot of funding from the government and various agencies for research in biosciences. This funding is different as it is very flexible and we are given the liberty to do anything with it which we could not do with other kinds of funding. While other funds are supposed to be used only for research, we will use this fund for infrastructure and for getting faculty. Presently, around five-to-six faculty members from IITB's Department of Biosciences and Bioengineering (DBSBE) will be engaged in research in this center.â€? The initial funding of 25 crore to IITB is for a stipulated period of five years. Wadhwani's initiative targets generating 25-to-30 world-class faculty and 100-150 post-graduate students engaged in cutting edge research, supported by an international advisory board of well-known scientists. â€œThe intent is to catalyse additional centers of innovation across a variety of sectors in partnership with existing research institutes, government and industry. However, this might just be a few drops in the ocean but through our Foundation and our persistent efforts, we look at creating a difference to the research industry's growth prospects,â€? Prof Khakhar adds. Philanthropic funding for Innovation? For a sector reeling under the paucity of funding, Wadhwani Foundation's initiative has been given thumbs up by industry observers, who believe that it is a significant milestone in India's history of philanthropic funding. In the past, renowned academic institutions such as Mumbai's Institute of Chemical Technology have been receiving funds from corporates but a large part of it get used in non-scientific areas. Mr Nitin Deshmukh, head of private equity and chief executive officer at Kotak Private Equity Group, says, â€œWadhwani Foundation's initiative is definitely an important development and a new beginning in cancer research. In countries such as the US, research for various therapeutic areas has got a lot of backing from philanthropic funding organizations, but that has not happened in India.â€? â€œThis is a strong signal that academic institutions are moving away from just depending on government funding. In India, there is a dire need that funds comes for disease-related research, mainly in areas like vaccines, AIDS and diagnostics,â€? says Mr Vishal Gandhi, senior vice president and head, life sciences, Yes Bank. Industry observers opine that globally, organizations such as the Wellcome Trust and Bill and Melinda Gates Foundation have engaged in revolutionary work in funding basic research. It is high time that private and philanthropic funding follow a similar route in India. â€œIn India, the scale of research is much smaller compared to countries like the US. We need to boost that and above all, more investments are required. If you look at the US, they spend $300 billion in research, whereas we spend just $3 billion. The lack of funding and universities engaged in high-end research are the drawbacks,â€? says Prof Khakhar. â€œWorld-over, research is supported by a combined endowment of the government and private contributions but in India private contribution is minimal. This scenario should change and private participation should increase comprehensively. Philanthropic organizations can stimulate meaningful involvement in research that looks beyond surface-level research. This can ultimately help India to get a number of world-class research institutes,â€? adds Dr Wadhwani. Says Mr Ajit Mahadevan, partner - business advisory services, Ernst & Young, â€œGlobally, Howard Hughes, Wellcome Trust and Rockefeller Foundation are some of the large institutions supporting scientists all around the world (including India). A strong basic research infrastructure helps significantly towards creating an atmosphere and milieu that fosters and accelerates research.â€? The good news is that there are positive developments for India as funds are flowing in from private funding agencies such as the Wellcome Trust, Bill and Melinda Gates Foundation and the Clinton Foundation. The UK-based Wellcome Trust has made progress in collaborating with the DBT for funding basic research initiatives, both for companies and academic institutions alike. In 2008, the trust, along with the DBT, announced a 80-million- pound partnership (joint funding between the two) in order to boost biomedical research in India. The National Chemical Laboratory in Pune has been receiving funding from pharmaceutical companies for many of its research projects. Institutes like the IISC and TIFR have been created with significant support from corporates. â€œAs the need for innovation and research grows in India (along with prosperity and development), it can be expected that philanthropic donations in India towards research will also increase,â€? says Mr Mahadevan. Nayantara Som in Mumbai ]]> <![CDATA[Expand the biotech market]]> https://biospectrumindia.com/news/95/1531/expand-the-biotech-market.html https://biospectrumindia.com/news/95/1531/expand-the-biotech-market.html Thu, 08 Mar 2012 16:31:00 +0530 Nandita Singh The author is Editor of BioSpectrum nanditas@cybermedia.co.in What does the bioscience industry in India need? Many things. Actually, right from funding to technology access to talent pool to infrastructure et al the list can be long. However, more importantly what the industry needs is stepped up information sharing and a collaborative approach to opportunities. Both are internal impetus at the individual and company level, which at the collective scale translate into the buzzing culture of collaboration in the industry. At the recently concluded BioSpectrum Technology Forum 2012, in Delhi, there was a hint that this was the missing â€œpieceâ€? that can help propel the industry ahead. Delhi that boasts of a high concentration of research institutes saw thin participation from the industry at this R&D focused Forum. Maybe, it was reflective of the commitment industry and academia accord to such discussion Forums. Or maybe it was an overload of events and internal meetings that kept the audience away, as some industry leaders pointed out. After holding three such Forums, in three different metros, in the last six months, I must say Mumbai buzzed a lot more on the discussion, and experience and information sharing level, as compared to Bangalore and Delhi. So, how can you as an individual working in this industry benefit from participating in such industry Forums? I am putting down a simple 3-point guideline that you can utilize. Choose wisely but once you decide to participate in any such event, keep the commitment â€“ be it as a participant or as a speaker or panelist. At such Forums, there is not much of a differentiation between a panelist or participant, just about everybody present is an industry captain and can add to the discussion points as s/he deems fit. So, feel free to contribute. In fact, make sure that you contribute in some way or the other while you are there. Make notes of any ideas that the discussion may have generated and do share your thoughts, if time permits. And, if you believe the Forum could have been handled differently, do not shy away from giving feedback to the organizer. I am sure all of you know this already. After all, it's basic. However, the point is about making the time for practicing it and being out there. Now, that requires a certain degree of commitment, and factoring in time for this is worthwhile. While the immediate benefit may not be visible to you but as someone remarked to me recently: the network always works. So, make time for it. Don't miss such opportunities. By the way, BioSpectrum, this March, just finished nine years of creating such opportunities for you and is entering its 10th year with lots more on the agenda. Stay connected with us for more. Cheers! ]]> <![CDATA[Agri biotech undone by NGO protestors]]> https://biospectrumindia.com/news/95/1655/agri-biotech-undone-by-ngo-protestors.html https://biospectrumindia.com/news/95/1655/agri-biotech-undone-by-ngo-protestors.html Thu, 08 Mar 2012 16:29:00 +0530 The cat is finally out of the bag. And the cat has been let out by none other than Indian Prime Minister, Dr Manmohan Singh. For nearly two years, India's promising biotech agriculture sector has been shouting from the rooftop about the extraneous forces which have played dirty in the commercialization of the country's first genetically modified (GM) food crop, the Bt brinjal developed by Mahyco Monsanto. In mid-February, in an interview to the US magazine, Science, the Prime Minister has confessed that the undue pressure exerted by foreign-funded non governmental organizations (NGOs) were the main cause of delay in the commercialization of Bt brinjal, apart from slowing down of the country's nuclear power program. Of course, the PM did not name the NGO which has influenced the moratorium imposed on the introduction of Bt brinjal after the statutory regulatory agency, the Genetic Engineering Approval Committee(GEAC) approved its use in the country in October 2009. After the GEAC approval, the highly educated environment minister, Mr Jairam Ramesh, overruled the scientific and regulatory opinion on Bt brinjal's introduction and used a highly unusual nationwide public consultation jamboree, orchestrated by NGOs, over the next two months. And in February 2010, Mr Ramesh used his ministerial heft to stop officially-sanctioned commercialization of Bt brinjal. Since then, the GM food research work has more or less come to a halt. It suffices to say that apart from the dozens of local NGOs in different states, the international organization, Greenpeace, was and continues to be in the forefront of public efforts to stall the commercial cultivation of Bt brinjal in the country. Bioagri industry leaders have been talking in whispers about the periodic public spectacle of anti-GM campaigns organized across the country to keep the issue alive. In fact, the statutory clearance given by the GEAC is more than enough to start commercial cultivation of Bt brinjal. But various state governments too have gone with the â€œpopularâ€? sentiment orchestrated by anti-GM protestors and stood in the way of Bt brinjal cultivation. What is curious is that the UPA government of Dr Singh which gave official respectability to the NGO movement by setting up the National Advisory Council, staffed by NGOs, to set its policy agenda since 2004 has now turned itself against NGOs. This does not speak of very high standards of governance. Even in a democracy, there are enough legitimate channels available to make dissenting voices heard and influence public policy. But stalling the implementation of a regulatory decision on Bt brinjal on extraneous considerations is a puzzling act, not fully explained by the Prime Minister's off-the-cuff remarks on NGO power. As the nation gets set to celebrate the tenth anniversary of the introduction of its first GM crop, the Bt cotton, next month, the bioagri industry too should reflect on its failures on the Bt brinjal front. One can understand the reticence of government scientists to speak up strongly for biotech in the agriculture sector. But the industry has not covered itself with glory in the biotech story by its reluctance to counter the anti-GM campaign with a spirited public engagement with facts and figures on the benefits of GM food products. It is still not too late for India's bioagri sector to awake from its slumber. With this issue, BioSpectrum completes its ninth anniversary. The magazine is what it is today because of the committed and enlightened readers and leaders of the biotech industry. Happy Reading! Narayanan Suresh Chief Editor sureshn@cybermedia.co.in ]]> <![CDATA[Minds meet to fuel India's bioeconomy]]> https://biospectrumindia.com/news/95/1416/minds-meet-to-fuel-indias-bioeconomy.html https://biospectrumindia.com/news/95/1416/minds-meet-to-fuel-indias-bioeconomy.html Thu, 08 Mar 2012 16:14:00 +0530 The annual flagship event of the biotechnology industry in India reveals ways to promote the growth of country's emerging bioeconomy The 12th edition of the Bangalore India Bio held at The Lalit Ashok in Bangalore focused on the theme 'India - the emerging bioeconomy'. Over 400 delegates from 250 of the top biotech companies across 24 countries participated at the event to address their partnering and networking needs. The three-day event (Feb 6-8, 2012) witnessed several biotechnology and life sciences companies from North America, Europe and Asia share a common platform to meet and explore business opportunities with India's life sciences sector. The event was organized jointly by the Department of Information Technology, Bio-Technology, and Science and Technology, Government of Karnataka, the Vision Group on Biotechnology and MM Activ Sci-Tech Communications. Panel discussions @ Bangalore India BIO 2012 Day 1: The track on bio business focussed on discussions such as 'Biosimilar oppurtunities and regulatory harmonization'; and 'Trigerring investments in innovation and fostering entrepreneurship'; the track on bio nations was an 'Indo-German healthcare dialogue' and presentations by European Business and Technology Centre, the State of Pennsylvania, US, and APIICL. The CEO conclave was chaired by Dr Vijay Chandru, president, ABLE, and chairman & CEO, Strand Life Sciences, and was co-chaired by Mr Narayanan Suresh, group editor-Technology Review India and BioSpectrum, CyberMedia. Day 2: The event comprised tracks on diagonostics (Next generation genomics and making sense of complexity; Clinical and contract research-building capabilities through strategic partnerships; and Transforming healthcare through companion diagnostics) and on healthcare (Stem cells and regenerative medicine; Medical technology, devices and biomedical instrumentation; and Scientific evidence-based natural and traditional knowledge in healthcare). Day 3: The discussions were on transformational technologies (Role of high performance computing in accelerating innovation in biotechnology; Synthetic biology: How India should leverage on synthetic biology and Creating healthcare accessibility through mobile technologies) and agri and industrial biotech (Biotechnology for sustainable agriculture & food security and Biofuels and green chemicals). The discussions highlighted interesting research that is being done by the participating scientists. Dr Pawan K Dhar, director, Center for Biodesign, Symbiosis International University, shared how he had pioneered the field of Junkomics by making genes out of junk DNA. Recognizing talent @ Bangalore India BIO 2012 Bangalore BIO 2012 also served as a fitting platform to honor those who excelled in the biotechnology industry in the last year as well as those who showed great potential and were emerging entities in the biotechnology space. This year two awards were given in each vertical, one to an established company and another to an emerging one in the same category. The awards selection process was carried out by ABLE, led by a jury comprising many industry stalwarts. The Bioexcellence Award in the Biopharma & Healthcare vertical was given to Serum Institute of India for its pioneering role in the vaccine industry and the Emerging Company of the Year award in the same category was given to Embrace, a company producing low cost infant warmer designed for developing countries. Similarly, Mahyco won the Bioexcellence Award in the BioAgri vertical. Quintiles and Semler Research Centre were awarded the Bioexcellence Award and the Emerging Company of the Year award respectively in the BioServices category. The BioIndustrial vertical recognized those companies actively researching ways to find environmentally safe and sustainable solution to the energy problems. PRAJ Industries was given the Bioexcellence Award while Sea6 Energy, a young start-up, was adjudged the Emerging Company of the Year. Ocimum Biosolutions was given the Bioexcellence Award in the Bioinformatics & Systems Biology space and the Emerging company award was shared by Ganit Labs & Xcelris Labs. Additionally, poster awards were given to students from Enterovirus Research Centre, ICMR, Mumbai; Centre for DNA Fingerprinting and Diagnostics, Hyderabad; and The Energy and Resources Institute - TERI, New Delhi. Exhibitor awards were given based on design, biocontent and the interactive nature of the different exhibitors at this event. Speaking at the inaugural ceremony, Mr Ghulam Nabi Azad, minister of health and family welfare, Government of India, said, â€œOur regulatory system is still inadequate. A new system to address the complexities in this emerging field is required. A task force has been constituited in this regard.â€? Speaking about the increasing opportunities in this sector, he said, â€œWe provide pharmaceuticals to about 115 countries and vaccines to about 150 countries. I hope the biotech industry seizes the emerging â€œopportunitiesâ€?. Mr D V Sadananda Gowda, chief minister of Karnataka, who presided over the multi-track conference program, released the â€œIndustry Report for the biotechnology sector in Karnatakaâ€? brought out by BioSpectrum on the occasion. In the presence of late Dr V S Acharya, minister for higher education, planning and statistics, muzrai, and information technology and biotechnology, Government of Karnataka, a memorandum of understanding was signed between the Pennslyvania state, US, and Karnataka Biotechnology and Information Technology Services (KBITS), Government of Karnataka, for collaboration in the biotech sector. US-India Business Council (USBIC) President Mr Ron Somers, delivering the inaugural keynote address, said, â€œWe are facing great challenges in our global economies, but innovation will enable us to overcome these obstacles and achieve success in the 21st century. With Karnataka's youthful demography, a dizzing array of educational instituitions, R&D taking place in virtually every industry, and a perfect climate, the only elements requiring further attention are the need to develop world-class infrastructure and putting in place a welcoming policy.â€? Release of the BioSpectrum 'Industry Report for the biotechnology sector in Karnataka': (L-R)Mr Chakravarthi Mohan, MD, KBITS, and director of Karnataka Department of IT/BT; Mr Ron Somers, president, US India Business Council; Late Dr VS Acharya, minister for higher education, planning and statistics, muzrai and IT & BT, Government of Karnataka; Mr DV Sadananda Gowda, chief minister, Karnataka; Mr Ghulam Nabi Azad; minister, health and family welfare, Government of India; Dr Kiran Mazumdar-Shaw, chairperson, Karnataka Vision Group on Biotechnology; and CMD, Biocon; Dr M K Bhan, secretary, DBT, Ministry of Science and Technology, Government of India; Mr M N Vidyashankar, principal secretary, Department of IT, BT and Science and Technology, Government of Karnataka. Panel at the CEO Conclave: (L-R) Dr Suri Venkatachalam, CEO and MD, Connexios Life Sciences; Dr Rashmi H Barbhaiya, CEO and MD, Advinus Therapeutics; Mr K V Subramaniam, president and CEO, Reliance Life Sciences;Mr Narayanan Suresh, group editor - Technology Review India and BioSpectrum, CyberMedia; Dr Vijay Chandru, president, ABLE, and chairman and CEO, Strand Life Sciences; Mr Sridhar Mosur, CEO and president, global discovery and development, Jubilant Life Sciences; Mr D A Prasanna, CMD, Ecron Acunova; Mr Jignesh Bhate, founder and CEO, Molecular Connections. Policy makers: Mr Ghulam Nabi Azad; minister, health and family welfare, Government of India; having a chat with Mr DV Sadananda Gowda, Chief Minister, Karnataka Distinguished members of the audience at Bangalore India Bio 2012 Signing the MoU: Mr Chakravarthi Mohan, MD, KBITS, and director of Karnataka Department of IT/BT (L); and Mr Christopher P Molineaux, president, Pennsylvania Biotechnology Association (R) Releasing the Bangalore India BIO 2012 Programme Document: (L-R) Mr Ron Somers, president, US India Business Council; Late Dr VS Acharya, minister for higher education, planning and statistics, muzrai and IT & BT, Government of Karnataka; Mr DV Sadananda Gowda, Chief Minister, Karnataka; Mr Ghulam Nabi Azad; minister, health and family welfare, Government of India; Dr Kiran Mazumdar-Shaw, chairperson, Karnataka Vision Group on Biotechnology; and CMD , Biocon Dr M K Bhan, secretary, Department of Biotechnology, Ministry of Science and Technology, Government of India, said biotech is an instrument to fulfill human needs and called for nurturing innovation. â€œScientific manpower will be increased by 80 percent in the next five years,â€? he said. Delivering the biotech industry's perspective, Dr Kiran Mazumdar-Shaw, chairperson, Karnataka Vision Group on Biotechnology, and CMD, Biocon, elaborated on the importance of biotechnology with its all-pervading impact on all aspects of life. â€œKarnataka has taken huge strides in biotechnology. We have diversity and innovativeness,â€? she said. Mr M N Vidyashankar, principal secretary, Department of Information Technology, Biotechnology and Science and Technology, Government of Karnataka, in his welcome address said, â€œBioeconomy has the blueprint to change the way the world functions and Karnataka has a healthy mix of desirable elements to promote biotech.â€? The event also provided an excellent platform for the BT Finishing School students to interact with industry representatives. This Bangalore India BIO was the first event that saw workshops being conducted for the students of the BT Finishing Schools. Mr Raghavendra B T, a student from JSS College, Mysore, said, â€œThe event helped us meet people from the industry and was instumental in generating new ideas in our minds. The sessions on biofuels, stem cells and traditional knowledge were particularly thought provoking. Moreover, the workshops on soft skills and drafting grant applications will certainly help us in the future.â€? The three-day event included multi-track conferences, vison leadership series, bioexcellence awards, international tradeshow, CEO conclave, bioquiz, biopartnering and poster presentation. The event highlighted the willingness of the international pharmaceutical and biotechnology companies to work with Indian companies and also pointed out the measures that India needs to take in order to fuel its growth in the life sciences sector. Glimpses Innovation must meet investments Dr MK Bhan, secretary, DBT, shared his thoughts on building India's biotech industry. â€œThe growth of bioeconomy is dependent to a large extent on public policy and other external factors. The next 20-25 years are going to be really exciting for the biotech field. However, there needs to be an improvement in our university system where 80 percent of our scientific investments do not produce any invention. The institutional framework and the educational system should ideally be such that innovation is clearly absorbed by the industry and that is not the case presently. It is not just about budget but about engagement, as the Government of India is eager to provide funds for biotechnology. The greatest challenge in innovation in biotechnology is how to champion this understanding and experience that we have to create a value chain that can benefit people.â€? Getting past regulatory hurdles Many Indian manufacturers are developing strategies for increasing their market share in the biosimilar space. However, India still lacks a comprehensive list of guidelines for approval of biosimilar drugs. Mr Hareesh Parandhaman, assistant director - Business Development, Lupin (Biotech Division), spoke about two strategies. â€œCompanies can adopt a bottom up approach which involves identifying the regulatory pathway to the first market and then to generate data as required for the first market which could reduce time in clinical trials. The other top down approach involves first identifying the potential markets and then pooling the data required for each market into groups. The next step would be to evaluate the harmonized requirements of the majority markets and to plan the clinical trials in the local markets,â€? he said. Dr V K Vinayak, chief scientific officer, Biologicals, Panacea Biotec, highlighted the regulatory challenges involved. â€œAccording to the US Healthcare Bill 2010, biosimilar producers should provide full dossiers and details of the manufacturing processes to the reference competitor if the application is through a biologics license application. This would make it very difficult for biosimilars manufacturers to enter the market. The other option would be to go through the lengthy regulatory process, as an entirely new product.â€? Collaborations are the way forward CROs are forming strategic partnerships in order to have sustained flow of contracts from biotech and pharma companies. One such example happens to be the partnership between Ecron Acunova and Boehringer Ingelheim India. Dr Partha Gokhale, head - Clinical Operations India, Boehringer Ingelheim India, said, â€œThere is a tremendous opportunity to market drugs in Asia due to availability of a fast growing market, research frequency and time saving due to huge population, high disease incidence and increasing life expectancy that allow us to develop knowledge and capability through alliances and partnerships but challenges like unavailability of ready sites for clinical trials and difficulties in importing drug samples do remain.â€? Dr Surinder Kher, chief executive officer, Asia, Ecron Acunova, seconded the advantages of working through partnerships. â€œIt is important to be patient with regulatory challenges when we are working in Asia. It is always better to work in collaboration so that we can be leaders in specific sectors of contract research. India needs to focus on capability building for phase I trials and the idea of a school for regulators, mooted by Dr M K Bhan, is a positive step in this direction,â€? he added. The Germany-India Year Dr Ingo Karsten, consul general of the Federal Republic of Germany, Bangalore, said as part of the celebrations for the Germany-India year 2012, several events are being organized in the different German centers across India. He revealed that the events would be held in Bangalore from June 22 to July 1, 2012. Pharmerging Andhra Pradesh Mr K Praveen Kumar, VP, marketing and investment promotion, Andhra Pradesh Industrial Infrastructure Corporation, said Andhra Pradesh is emerging as the new hub of life science in India. He said the Government of Andhra Pradesh has made significant investments in the state resulting in the setting up of several state-of-the-art biotech parks in Hyderabad, Vizag and Nellore and others. He further revealed that new biotech parks and special economic zones are coming up. High hopes: Stem cell therapies A recent Frost and Sullivan report presents a positive picture and says opportunities for stem cell-based therapies are estimated to be at $1.5billion in Asia Pacific countries and India. Stempeutics is hopeful of launching its product, Stempeucel, by 2015. Mr B N Manohar, CEO of the company, said regulatory challenges were the major stumbling block in India and there is a need for the different committees to approve clinical trials for stem cell drugs. The academia too are heavily involved in stem cell research. Institutions such as the Centre for Stem Cell Research, Christian Medical College, NCRM and Nichi-In Centre for Regenerative Medicine are carrying out cutting edge research in developing stem cell therapies. Future of Junkomics People are scared to throw away raw data obtained from genome sequencing as the data is obtained painstakingly. These data, which do not mean much at the moment, may emerge to be of critical importance in the future with the advent of new algorithms. Dr Pawan K Dhar, professor, Symbiosis School of Biomedical Sciences director, Center for Biodesign, Symbiosis International University, has started to explore possibilities of finding functions of non-coding intron regions of the gene (also called as junk DNA). Humorously labeling his research as â€œJunkomicsâ€?, Dr Dhar said he found that when certain introns of cancer coding genes were activated in a cell line, it led to the death of the cells. The funding issue Entrepreneurs, academicians and investment bankers gathered were all of the opinion that innovation needs to be rewarded in India to be truly encouraged. In a bid to create an engaging environment to foster innovation, Dr Kiran Mazumdar-Shaw, CMD of Biocon, has suggested that an alternative stock exchange be created that can create value for companies based on innovation. Dr Shaw elaborated, â€œThere is a need for true innovation to be appropriately valued so that it can be efficiently translated into a product. Stock exchanges, such as NASDAQ, are truly a great example that can be emulated in India to facilitate funding for smaller companies. We are already in talks with SEBI regarding this idea and hope for it to become a reality soon.â€? Dr Vijay Chandru, CEO Strand Life Sciences who co-founded the company, seconded this idea when he said, â€œThere is tremendous potential in biotech start-ups to actually make it big, if given the right kind of funding at the right time. Genentech, which was started based on just an innovative idea is a perfect example of this. Today, various networks, TDP, CSIR and government bodies, such as DBT, make small and large-scale investments that can help entrepreneurs convert an an idea to a product.â€? Mr Utkarsh Palnitkar, MD, Pluripotent Capital, Executive Director, Centrum Capital, pointed out that few in the investors community who valued innovation â€œwhich makes it tough for start-ups to get any funding from themâ€?. â€œIncentives like tax breaks for investing in start-ups that have already been given some ignition grants from the DBT and thus have established their credibility can encourage venture capitalists,â€? he said. "Quote Unquote" When information is independent of space and time, it becomes knowledge. - Mr Asoke K Talukder, CSO, Geschickten Biosciences, Bangalore Are members of the Gujarati community in Houston, US, (whose genome had been sequenced and data used for various genome research projects) representative enough of the whole of India? Is India trying to create a standard Indian genome? - Dr Vijay Chandru, president, ABLE chairman & CEO, Strand Life Sciences The applications of recombinant DNA technologies have revolutionized the way one can incorporate valuable traits in the important crops. India should, without any hesitation, adopt modern technologies for increased sustainability and food security in the country. Future of GM crops is bright and political expediency must not be allowed to sacrifice a good technology. The success of Bt cotton has demonstrated that our farmers are wise and not led by controversies. - Dr M Mahadevappa, former VC, UAS Dharwad Today consumers demand more than just safe food. They want food that is wholesome and of high quality. And to meet these demands, food processing technolgoies such as thermal processes, novel processes making use of alternate heating media as well as non thermal processes have evolved and which India should start adopting. - Dr Hosahalli S Ramaswamy, professor, Department of Food Science, McGill University, Canada Manasi Vaidya, Saptarshi Chaudhuri, Uma Kelath & Vipul Murarka ]]> <![CDATA[BioSpectrum Technology Forum: February 24, 2012 @ Delhi]]> https://biospectrumindia.com/news/95/2439/biospectrum-technology-forum-february-24-2012-delhi.html https://biospectrumindia.com/news/95/2439/biospectrum-technology-forum-february-24-2012-delhi.html Thu, 08 Mar 2012 15:59:00 +0530 Sessions & Panelists A perspective on R&D direction setting: Dr VK Vinayak, Industry Expert & CSO Biologicals, Panacea Biotec Stem Cells & Gene Therapy (Trends and Policies): Dr Mrinalini Chaturvedi, Director, Cryo Banks International; Dr Alka Sharma, Jt Director, Department of Biotechnology; Dr Venkatesh Ponemone, Director, Laboratory and Clinical Research Affairs, Fortis- Totipotentrx Centrer for Cellular Medicine Next Generation Innovation: Dr Geetha Vani Rayasam, Open Source Drug Discovery, CSIR; Dr VK Vinayak, CSO-Biologicals, Panacea Biotec; Dr Navin Khanna, Group Leader, Gene Recombinant Lab, ICGEB; Dr Alok Adholeya, Director of Biotechnology & Bioresources Division, The Energy and Resources Institute (TERI) Bringing Technology/ Enabling Science: Dr VL Ramprasad, Chief Scientist- Genomics, Spinco Public Private Partnerships: A case for excellence: Mr Pankaj Sharma, CEO, LeadInvent; Parul Saxena & Javed Ahmad, Jamia Hamdard Universitry Team; Dr Jitendra Verma, MD, Lifecare Innovations, Dr Ravi Dhar, Senior Consultant, BIRAP, DBT Computer-aided Drug Discovery: Dr B Jayaram, Head-Computational Biology, IIT, Delhi; Mr Sahil Kapoor, CEO, Novo Informatics; Prof. Indira Ghosh, Dean, School of Computational and Integrative Sciences, Jawahar Lal Nehru University, Mr Pankaj Sharma, CEO, LeadInvent BioSpectrum Technology Forum 2012 (BSTF) in Delhi saw the industry leaders getting together on the theme: â€œGame Changers in Drug Discovery & Developmentâ€?. This was the third leg of the one-day BSTF series that brings together R&D leaders of the bioscience industry. The first two legs of the series were held in Bangalore and Mumbai, respectively. The sessions spanned diverse topics ranging from stem cells and gene therapy, to next generation innovation, public private partnerships, and computer-aided drug discovery. The discussion on public private partnerships was an addition to the Forum agenda keeping in view the role such partnerships are playing in taking the industry further and its enormous potential. The panel discussion on â€œpublic private partnershipsâ€? was chaired by Dr Ravi Dhar, Senior Consultant, BIRAP, DBT. The conference was opened by Dr Renu Swarup, Senior Adviser, Department of Biotechnology, who in her opening address elaborated on the BIRAP initiatives for the industry and how industry can benefit from these. Dr VK Vinayak, an industry veteran and CSO, Biologicals at Panacea Biotec, gave his perspective on the research direction the industry needs to take and also tied-up and summarized the key points from the industry. The industry leaders shared their perspective and insights across the range of topics. Many of you missed the action. However, we are not putting in a full report here, it will be available on our website, in a month or so, when the BioSpectrum new online platform goes live. BSTF 2012 at Delhi was supported by: Department of Biotechnology, Government of India, and Spinco Biotech. Nandita Singh, Editor, BioSpectrum, welcomes the panelists and delegates Dr VK Vinayak, industry expert & CSO Biologicals, Panacea Biotec, and a panelist at the event, sets the tone for discussion Dr Renu Swarup, Sr Advisor, DBT, gives the inaugural address BSTF Panelists @ Random Dr Venkatesh Ponemone, Fortis- Totipotentrx Centre for Cellular Medicine Dr Mrinalini Chaturvedi, Cryo Banks International Dr Alka Sharma, Department of Biotechnology Dr Navin Khanna, Gene Recombinant Lab, ICGEB Dr Geetha Vani Rayasam, Open Source Drug Discovery, CSIR Dr Alok Adholeya, The Energy and Resources Institute (TERI) Dr VL Ramprasad, Spinco Dr Ravi Dhar, BIRAP, DBT Jitendra Verma, Lifecare Innovations Mr Pankaj Sharma, LeadInvent Parul Saxena, Jamia Hamdard University Mr Sahil Kapoor, Novo Informatics Dr B Jayaram, IIT, Delhi Prof Indira Ghosh, Jawahar Lal Nehru University ]]> <![CDATA[Industry thrust is key to battle against TB]]> https://biospectrumindia.com/news/95/7550/industry-thrust-is-key-to-battle-against-tb.html https://biospectrumindia.com/news/95/7550/industry-thrust-is-key-to-battle-against-tb.html Thu, 08 Mar 2012 15:58:00 +0530 The number of TB infected people and deaths is growing year-on-year in India. However, a major portion of the research in this area is conducted within government-funded research institutes and the industry is yet to actively participate in such projects Although India has a long history of tuberculosis (TB) research, the disease continues to remain a major health issue in the country. According to statistics from the World Health Organization (WHO), India accounts for one-fifth of the global TB cases. Each year, nearly two million people in India contract TB, of which around 870,000 are infectious cases. It is estimated that annually around 330,000 Indians die due to TB. Lack of availability of TB drugs, high costs of treatment with the few drugs that are available and issues pertaining to early diagnosis of the disease are the primary reasons. In addition to this, the emergence of multi-drug resistance TB (MDR-TB) and extensively drug resistance TB (XDR-TB) have caused significant concerns in eradicating the disease. Conventional market-based patent incentives are ineffective in addressing the public health needs in developing countries, with only one percent of the newly developed drugs targeting neglected diseases. New, highly potent and fast acting drugs with short treatment regimen are essentially required for treatment of tuberculosis, which has seen a slow pace. According to reports, between 1975 and 2004, only three out of 1,556 new chemical entities arrived in the market for TB treatment. Pioneering studies from India demonstrated the efficacy and safety of domiciliary treatment, the necessity of direct observation of treatment, the feasibility of case detection through sputum smear microscopy in primary healthcare institutions, and the effectiveness of intermittent short-course chemotherapy. These findings laid the foundation for the Directly Observed Treatment Short course (DOTS), which has been adopted by nearly 150 countries. Today, India has the second-largest and the fastest-growing DOTS program in the world. While a chunk of basic research is currently being conducted within the realms of academic institutions and government-funded research institutes, companies in India are still apprehensive about allocating their R&D budgets for TB. Dr KK Bhutani, officiating director, National Institute of Pharmaceutical Education and Research (NIPER), Mohali, says, â€œThere is TB research happening in India and I know of around 52 research institutes conducting groundbreaking research in the country.â€? Despite the grim situation, industry experts are positive that given the presence of a fast growing life sciences industry, India has a huge potential in leading TB research. Dr Lucica Ditiu, executive secretary, Stop TB Partnership, comments, â€œThe challenge is clearly huge, but India is rising in the global health arena. The country is moving towards universal access to quality TB care. It has the world's fastest growing pharmaceutical industry and huge potential to become a global frontrunner in biotech, medical and public health research.â€? Is the focus of companies changing? Companies are yet to purge the 'commercialization' bug out of their system, opine industry observers. This is the root cause for them to keep distance from TB research. â€œCompanies in India are following the model of their counterparts in the West - of looking at return on investments. I know of innumerable small R&D labs who came up with innovative molecules in TB but then dropped them due to this business outlook,â€? says Dr Ashok Vaidya, research director, Kasturba Health Society, Mumbai, and director, clinical pharmacology, BSES MG Hospital, Mumbai. Above all, TB drugs coming under the ambit of the drug price control has proved to be a major dampener for TB research in the country. â€œThe industry follows a formula of 10 is to 90, which means putting 90 percent of their revenues for only 10 percent of the diseases. Nobody today gives any importance to neglected diseases. India does not have a dearth of R&D funds but a lack of initiation in TB research,â€? says Dr K Satyanarayana, scientist G, Indian Council of Medical Research, New Delhi. Few players in the field Due to the prevalent situation in the country, there are companies who are taking novel steps towards TB research, including Lupin Pharma and AstraZeneca Pharma India among others. AstraZeneca rolled out ambitious plans in TB. Its discovery research center in Bangalore is part of their global infection innovative medicines unit, focused on TB research and other diseases that are found primarily in the developing world. The team is collaborating with leading names in their respective fields to meet this objective. Mr Anandh Balasundaram, managing director, AstraZeneca Pharma India, earlier said to BioSpectrum, â€œWe have delivered a candidate drug to treat TB in both its drug-sensitive and drug-resistant forms, which also offers the potential to shorten the duration of therapy. The compound is in phase II clinical trials. In addition to TB research, the team supports our antibacterial discovery efforts in close collaboration with colleagues at AstraZeneca's R&D site in Massachusetts, US.â€? An investment of $22 million has been made in the TB research center in Bangalore. Global Alliance for TB Drug Development (TB Alliance) and AstraZeneca announced in 2010 that they had entered into a research collaboration agreement to accelerate discovery, development and clinical use of drugs against TB, including drug resistant strains of the disease. The joint portfolio will be resourced by a core group of scientists based at AstraZeneca's TB research center in Bangalore with expertise and funding from both organizations. Promising compounds identified in this collaboration will also be tested in combination with other therapies as part of the critical path to TB drug regimens, a cross-sector initiative intended to speed TB drug regimens for patients who need them. Lupin has been at the forefront of the Indian anti-TB market, commanding a large market share in the segment. It is one of the leading global manufacturers of rifampicin, besides being the largest manufacturer of ethambutol. Lupin also collaborated with the Council of Scientific and Industrial Research (CSIR) in the development of anti-TB drug candidate sudoterb (LL 3858), which is now in the clinical trials stage. The novelty of this drug is that it will potentially bring down the treatment time to two-to-three months while the normal treatment time is six months. In the past, Cadila Pharmaceuticals also collaborated with the CSIR to develop a drug called risorine. Another prominent sub-segment within the field of TB is the diagnostics market. The importance of this segment has fueled interest in the light of a large number of undiagnosed population in India for TB. Most of the existing testing products for TB (in-vitro diagnostics market) is mainly imported, making treatment an expensive process for the common masses. There is thus an urgent need for domestic indigenous companies to come up with innovative diagnostic solutions making treatment affordable. Although it is difficult to size this market, a preliminary study by Mckinsey suggested that the annual TB diagnostics market in India might be worth $100 million, although there is uncertainty surrounding the estimates from the private sector, which does not report TB-related statistics. Companies that are pursuing this domain include Tulip group, Span Diagnostics, Bigtec and Achira Labs. In February 2012, Avesthagen signed a memorandum of understanding (MoU) with CosmosID, a US-based company, for collaborating to correctly diagnose and therapeutically manage tuberculosis treatment. Avesthagen and CosmosID will pool their expertise to identify the particular TB strain and thereby support proper treatment. The collaboration is expected to result in a new method for developing diagnostic kits for rapid screening of patient samples. Government initiatives Open Source Drug Discovery (OSDD), which is a first-of-its-kind government initiative, was launched in September 2008 by the CSIR. It is a $35 million collaborative research effort that focuses primarily on TB. The vision of OSDD is to provide affordable healthcare to the developing world by providing a global platform where scientists can collaborate and collectively solve complex problems associated to discovering novel therapies for neglected tropical diseases such as TB, thus accelerating research for TB drugs. To achieve this goal, OSDD aims to reduce the risks in the discovery stage by facilitating collaborations between scientists, doctors, technocrats and students through a collaborative platform. Research Institute Work Conducted in TB National Institute for Research in TB, Chennai Randomized clinical trial to study the efficacy and tolerability of three-times-a-week gatifloxacin and moxifloxacin, containing regimens in the treatment of sputum positive pulmonary TB Randomized clinical trial to study the efficacy and tolerability of three and four month moxifloxacin containing regimens in the treatment of sputum smear positive pulmonary TB HIV vaccine study National Tuberculosis Institute, Bangalore Study on the status of pulmonary TB patients put on treatment under the Revised National Tuberculosis Programme in Bangalore Mahanagara Palike. Study on treatment outcome of smear positive pulmonary TB patients treated under the Revised National Tuberculosis Control Programme. Study on surveillance of drug resistance in the district of Mayurbhanj,Orissa; Hooghly, West Bengal; and Nagaon, Assam. Co-ordinated research between the International Center for Genetic Engineering and Biotechnology, New Delhi; University of Delhi, South Campus, New Delhi; Acharya Narendra Dev College, University of Delhi, New Delhi; Sri Venkateswara College, University of Delhi, New Delhi; Institute of Mathematical Sciences, Chennai; and Central Jalma Institute for Leprosy and other Mycobacterial Diseases, Agra The major focus is to identify antigens or combination of antigens that can potentially be used as vaccine candidates against TB alongwith identification and validation of genes involved in the pathogenesis of Mycobacterium tuberculosis, which are essential for the survival of pathogen in the host. Identification of new drug targets and understanding of the mechanism(s) of pathogenesis will also be carried out. The system biology of the Mtb-macrophage interaction will be studied by combining mathematical modeling with experimental approaches ILS Institute of Tuberculosis and Respiratory Diseases, New Delhi Assessment of the Revised National Tuberculosis Control Programme Strategy and FNAC diagnosis (at two weeks) and six months duration of treatment for peripheral tubercular lymphadenitis Identification of biomarkers and pathogen regulated targets for tuberculosis infection Role of suppressors of cytokine signaling during Mycrobacterial tuberculosis infection Validation and clinical studies for method for diagnosis of tuberculosis by smear microscopy, culture and polymerase chain reaction using processed clinical samples and kit thereof All India Institute of Medical Sciences (Biotechnology), New Delhi Molecular pathogenesis with reference to dormancy adaptation of Mycobacterium tuberculosis TB Inhibitor discovery and development Deciphering host-Mtb interactions Developing a tool box for the diagnosis of tuberculosis CSIR's Open Source Drug Discovery Initiative It is a global platform where scientists can collaborate and collectively work to solve the complex problems associated with discovering novel therapies for neglected tropical diseases like TB, thus accelerating research for TB drugs. To achieve this goal, OSDD aims to reduce the risks in the discovery stage by facilitating collaborations between scientists, doctors, technocrats and students through a collaborative platform National Institute of Pharmaceutical Education and Research, Mohali Novel aza-aromatics for tuberculosis activity against Mycobacterium tuberculosis Determination of the role of acute-phase reactants in the interaction of Mycobacterium tuberculosis with macrophages in vitro The latest development on this front is the release of its 'Connect 2 Decode' (C2D) project to re-annotate biological and genetic information relating to the Mycobacterium tuberculosis (Mtb) genome. C2D's findings may help to reveal the previously undiscovered details of TB, resulting in development opportunities for urgently needed new TB drugs in India and other developing countries. This is the first time that a comprehensive mapping of the Mtb genome has been made publicly available. Under the C2D project, researchers and students pooled their time and skills using online tools to provide insights into 4,000 genes of the deadly pathogen. The researchers also mapped the genes as they relate to functional interactions and pathways. Their work is held in a shared database, which the OSDD will share through a globally accessible database with any research institutions involved in TB research through its open portal. The gene map is similar to a Google map or a Wikipedia article that can be modified and updated as new information emerges on the features of the genome. â€œWe need to have a balanced view between health as a right and health as a business. It is because there has been imbalance in this view that diseases like TB, with high mortality but low profitability, are neglected by the current system of pharmaceutical research,â€? says Dr Samir K Brahmachari, director-general, Council of Scientific and Industrial Research (CSIR). â€œAs virtually no new TB drugs have been developed since the 1960s, the OSDD's model in particular holds great promise for the scientific community by stimulating the development of better drugs and diagnostics for patients.â€? India is very much on the agenda of the Stop TB Partnership. â€œIn late August, we joined a meeting in Bangalore on the development of new diagnostics. In the same month we organized meetings with the government to discuss global TB drug shortages and to launch a new guide on the research needed to improve the quality and reach of TB care,â€? confirms Dr Lucica Ditiu. The Stop TB Partnership was established in 2000 to realize the goal of eliminating TB as a public health problem and, ultimately, to obtain a world free of TB. It comprises a network of international organizations, countries, donors from the public and private sectors, governmental and non-governmental organizations. Its secretariat is hosted by the WHO at Geneva and from there, it has been transforming the fight against TB in more than 100 countries. Furthermore, WHO India has provided technical support to the Revised National Tuberculosis Control Programme in its research activities with Tuberculosis Research Center, Chennai, and with other agencies and in the surveys to assess the impact of different TB control measures. It also provides technical support to the National TB Institute in operational research and impact assessment surveys. In conclusion, it can be said, that while the government is playing a proactive role in bolstering TB research, the industry needs to chalk out models wherein a balance between business and needs of the public at large is maintained. Prospective areas of research now include vaccines and diagnostics tools for TB. Nayantara Som in Mumbai, (with inputs from Rahul Koul in New Delhi) ]]> <![CDATA[Different crops, different norms?]]> https://biospectrumindia.com/news/95/1800/different-crops-different-norms.html https://biospectrumindia.com/news/95/1800/different-crops-different-norms.html Thu, 08 Mar 2012 15:56:00 +0530 A policy paper of the National Academy of Agricultural Sciences recommends classification of GM crop events based on perceived bio-safety risks. BioSpectrum takes a look at both sides of the debate The latest policy paper authored by the National Academy of Agricultural Sciences (NAAS) on biosafety of genetically modified (GM) food crops in India raises few important points. Among them is the need to have a transparent time-bound decision making system for rejection or acceptance of the GM crop events taking care of all the concerns. It highlights the need to strengthen the public sector laboratories conducting bio-safety evaluation and establishment of accredited private sector bio-safety labs for crops and food products. The reason cited is that there will be a deluge of GM crop events in the coming future and the physical and administrative infrastructure should be commensurate with the demand. â€œWe need to strictly enforce regulations on the ground because a good regulatory act, if poorly implemented can bring disrepute to this wonderful technology,'' states the policy paper. Due to the long gestation period for the development of useful GM crop events and the high cost of R&D, there seems to be a need to have a sound biosafety evaluation and regulatory infrastructure. Regulatory hurdles Raising an important point, the NAAS paper highlights the need to classify GM crops. It recommends the classification of GM crop events based on the perceived bio-safety risks and calibration of the level of regulation. For example, a gene from a food crop or another edible life form being transferred to another food crop need not go for an elaborate toxicity and allergenicity testing. Similarly, a protein coming from a distant source like soil bacterium but already tested extensively for toxicity and allergenicity need not be tested again and again because it will unnecessarily delay the deployment of a benign gene for the benefit of society. Dr Seetharama Nadoor, executive director, Association of Biotechnology led Enterprises-Agriculture Group (ABLE-AG) says â€œregulatory bodies appointed by the government are very strict, and study all the mandatory research data placed before it, and only after giving serious considerations to each aspect of safety and utility of any new product, it gives a go-ahead signal.â€? â€œThere is no reason for any concern on the thoroughness and seriousness of the decision making process. The academy has rightly emphasized this aspect in its policy paper,â€? says Dr Nadoor. Sharing his views, Mr Sushil Karwa, managing director, Krishidhan Group of companies, says, â€œThe policy paper from NAAS on biosafety recommendation is a comprehensive report on the present and the way forward in biosafety. It also states that India has one of the stringent regulatory handling expertise with international standard norms and practices. However, there is a need for capacity building, so that large numbers of GM samples are handled efficiently, and there is also a need to promote education on biosafety so that undue fear could be addressed within society. Risk assessment and communication centers are prerequisites for India due to its complex diversity and culture. Once such centers are established, a more focused public-centric pooling on GM technology could be sought for creating better science-driven decision-making scenarios.â€? The debate is on In a country where politics has to be a part of every process, the moratorium decision surely created a lot of heartburn within scientific circles. However, many prominent scientists working in the area are of the view that the central government will not be able to skip this issue for long. Researchers from government institutes are eagerly looking for a solution as the lack of a clear policy adds only to the confusion. Those supporting GM crops say that no agricultural technology is more promising or spreading faster around the world than GM technology for increasing production of safe food. The argument put forward is that biotech crops are crucial for food and nutritional security of the country and research must continue with the aim to develop safer, more productive and nutritious food crops. Another reason why the government is widely debating this issue of adoption of biotech products can be the fact that in India, with low per-capita resources, only technologies such as GM crops can help overcome the challenges of food, nutrition and protecting the environment. Many experts are of the view that it is now a foregone conclusion that all products proved to be substantially equivalent to non-GM sources will sooner or later find place in our daily foods. â€œWe must also be concerned with terrible opportunity costs of such delays in a country where one-third of the population goes to sleep hungry every day. Unfortunately, the government is somewhat held up when a small minority raises objections on non-scientific and trivial issues,â€? says Dr Nadoor. Factions opposed to GM technology want studies to scientifically justify that agribiotech products, especially GM crops, go through stringent regulations for better public perception and acceptance. Professor P Balasubramanian, department of plant biotechnology, Center for Plant Molecular Biology and Biotechnology, Tamil Nadu Agricultural University, Coimbatore, says, â€œThat it is almost impossible to prove that GM crops are completely safe is a fact. Several other established technologies which are widely used in the world are also supposed to be not absolutely safe. Yet the global population welcomed those technologies wholeheartedly and they are in use for a long time now.â€? Is market entry possible? With no clear policy direction on reconsideration of moratorium on Bt crops from the government, the chances of GM food crops being commercialized this year seem to be dim. Also, the much debated Biotechnology Regulatory Authority of India (BRAI) Bill is yet to be passed by parliament. Under such a challenging environment, it is difficult to visualize any additional product being marketed this year. Terming the ban on environmental release as unfortunate, Dr Nadoor says, â€œThere are many products in the pipeline, but unfortunately they are unduly held up. The unfortunate aspect of this holding back is not due to any safety or other substantial issues. The new challenge facing the industry is that agriculture is facing a state subject, and some state governments are delaying permission for field-testing.â€? Giving an example, Professor Balasubramanian points out, â€œNuclear power, personalized mode of travel (automobiles; no carpool or public transport but sedans for individual travelers who often get killed more often in road accidents) also fall in the same category of GM crops, but are well managed in the sense that it is possible to make them work towards chosen goals for human welfare. Those technologies have not been rejected outright by the people. Why this rage against GM technology alone? Our resource-poor farmers certainly deserves a better deal than the extant technologies which often prove more expensiveâ€?. He further adds, â€œBiosafety issues need to be analyzed not based on an armchair-wisdom but through analysis by those who practice GM science. Political issues should not complicate the decisions, unlike as is seen nowadays.â€? Mr Sushil Karwa believes that the safety concerns are very important. Sharing his viewpoint, he says, â€œBrinjal being a food crop which is consumed by many in India has genuine concern from society. However, most of the studies on biosafety have proved Bt Brinjal to be safe for human consumption and environmental cultivation. I think public awareness and pooling about the technology is something India needs to adopt so that the potential technology's benefits and risks are disseminated by science-based studies and public perception is sought at a wide scale.â€? As stipulated in the revised RCGM guidelines, the Indian Council of Agricultural Research will have to take a proactive role in the conduct and monitoring of biosafety cum-evaluation trials. This, as per recommendations in NAAS paper will help in reducing time line to bring the elite GM crop material to the farmers. Rahul Koul in New Delhi ]]> <![CDATA['We attribute our growth to our unique products']]> https://biospectrumindia.com/news/95/1838/we-attribute-our-growth-to-our-unique-products.html https://biospectrumindia.com/news/95/1838/we-attribute-our-growth-to-our-unique-products.html Thu, 08 Mar 2012 15:54:00 +0530 Mr Dhirendra Kumar, founder & CMD, Camson Biotechnology Camson Biotechnology is a leading agricultural biotechnology company based in Bangalore, since 1993. Camson is being termed as one of the fastest growing companies in the life sciences field with a growth rate of more than 90 percent over the last one year. Camson combines traditional knowledge in agriculture with latest advances in safety and protection, to market a wide range of products. These include hybrid seeds, bio-fertilizers and biocides that are non-poisonous, eco-friendly and residue-free. With more than 400 employees and 32 scientists working at labs located in Uttar Pradesh, Karnataka and Andhra Pradesh, Camson Biotechnology is geared up to move ahead with its philosophy of providing a supply of safe food, primarily through environment-friendly products, such as biocides, biofertilizers and hybrid seeds. From discovery to development, Camson has the defining science and multi-product manufacturing capabilities to bring innovative biotechnologies to farmers. Currently, it has more than 27 products with more than 45 biocides in the pipeline. Camson is also developing its own strains for biofertilizers which include nitrogen fixing and phosphorous or iron mobilizing bacteria. Mr Dhirendra Kumar, founder and CMD, Camson Biotechnology, speaks to BioSpectrum on expanding Camson's portfolio into genetically modified seeds using a unique intragenic technology as well as on foraying into other neighboring countries as well. QCan you explain the intragenic technology and the products lined up using this technology?  Mr Kumar:  Currently, all the leading bioagri companies are working on genetically modified organisms (GMOs) using genes from other unrelated organisms, as there is tremendous opportunity in that. However, we decided to go in a different direction and started working on the technology that involves the transfer of genes between related species using genetic techniques. We take pride in the fact that our research is based on lateral thinking. This technology, we hope, will face lesser problems from the regulatory aspect because of the principle of transferring genes between related species only, and we are thus projecting it as safe GMO. There are very few companies elsewhere in the world that are working on this technology. Currently, using this technology, we are working on the development of a virus tolerant species as well as the enhancement of antioxidants, such as lycopene and anthocyanin, in certain fruit and vegetable crops. Normally, the lycopene content in the species that we are studying is six percent. Through recombinant technology, we have already achieved a lycopene content of 15 percent, which has also been done in some labs in the US. We will hopefully launch the product next year when we reach 21 percent lycopene content. We are doing similar work with anthocyanin which is known to slow the aging process. QCan you tell us about Camson's other research areas, besides intragenic technology?  Mr Kumar:  Only one percent of microbes in nature can be cultured, hence we started a project related to metagenomics in which we transferred the genetic material of some of those microbes, which cannot be cultured into those that can be. We have got four products out of these studies, and we are in the process of obtaining patents for them. QWhere do you see yourself in the biotech industry in India?  Mr Kumar:  Camson has already created a niche for itself because of various unique products that we have brought into the market with our own technology. We are a true Indian company as all the products are produced in India and all the research is carried out here as well. QTell us about Camson's range of hybrid seeds?  Mr Kumar:  We were the first company in India to launch hybrid seeds for freezer watermelons, that, as the name suggests, fit into a freezer and are also higher yielding and non-leaky. We are the largest player in seeds for chillies as well as melons in India with unique hybrids such as yellow watermelons. We use innovative marketing practices for these products to increase their popularity. Looking ahead, we are conducting further research in other vegetables such as jalapeno peppers and cherry tomatoes, which are generally imported. These hybrids are being produced using marker assisted technologies. QWhat do you attribute the tremendous growth of the last three years to?  Mr Kumar:  We attribute our growth rate to our unique products. Today, people are getting an opportunity to buy something different and they are making use of the spending power. However, the fact that our products are allowing farmers to obtain adequate remuneration for their efforts is what drives us forward. QCamson is a publicly listed company. What prompted you to go in for an IPO and how has that experience been?  Mr Kumar:  In 1993, we were in need of funds, and at that time it seemed like the best option. But initially we got a listing only on the regional exchanges of Delhi, Bangalore and Hyderabad. And in a few years, those stock exchanges collapsed leading to a lot of difficulties. In 2008, we got listed at BSE and since the last four years, the experience has been good. QWhat are your future plans?  Mr Kumar:  We intend to export our products to other countries such as Turkey, Africa, Malaysia, Indonesia and have recently opened an office in Singapore to take care of the exports for the Asia Pacific market. We are also developing a range of biomanure. The country is undergoing a severe shortage of chemical fertilizers, so there is a lot of potential and we will launch it the next three to four months. These products have to be complimented with good agricultural practices for them to be truly effective. Camson is also about to launch the concentrated powder form of biocides, that will reduce the packaging costs and make it more convenient for the farmers. Liquid biocides are very heavy, which make transportation difficult. We are also looking to export these products. So, next year will be a different story altogether and we are very excited about that. We are very bullish about the future and it seems very bright. India is an important market for us, but we are planning to grow in other countries as well. Manasi Vaidya in Bangalore ]]> <![CDATA[Cracking the flu vaccine formula]]> https://biospectrumindia.com/news/95/1554/cracking-the-flu-vaccine-formula.html https://biospectrumindia.com/news/95/1554/cracking-the-flu-vaccine-formula.html Wed, 07 Mar 2012 17:32:00 +0530 After the swine flu pandemic, many companies in India took up the challenge of developing a vaccine according to a causative strain and have been successful in saving many lives Genesis In 1931, researchers at Vanderbilt University demonstrated viral growth in embryonated hens' eggs. The underlying principle for this technique is still used in the preparation of egg-based vaccines. The Technology Inactivated vaccines are prepared in a way that the virus is grown in a suitable culture system, either in an egg or in cells, and then killed using heat or other chemicals. The virus coat has glycoproteins on the surface of the virus, namely hemagglutinin and neuraminidase. These have different subtypes by which strains of the virus are known. They are designed in a way that the vaccine elicits immune responses that attack the neuraminidase and haemagglutinin proteins found on the surface. The Impact One of the earliest flu pandemics was known to be the Spanish influenza in 1918, which killed 50 million people. More recently, H1N1 influenza or swine flu claimed 18,000 lives worldwide with the Government of India reporting 2,728 fatalities till date. Even though most vaccines for swine flu were introduced after the peak of the pandemic, the development of such vaccines has allowed for the prevention of deaths from swine flu and proved that Indian companies possess the capability to develop influenza vaccines according to the causative strain. The technology for developing vaccines has evolved tremendously over the years but the underlying principle has remained the same, which is to trigger an immune response in an individual on administration of either the pathogen itself in its inactivated form or a component of it. Once that happens, our immune system develops a memory against that particular disease pathogen, such that on reinfection by the same pathogen, our immune system has the necessary antibodies to fight that infection. Today, cell culture-based vaccines that feature molecular technologies are used to produce vaccines according to different genetic varients of the virus. But if the virus has been built in such a way that the glycoproteins on its surface are constantly evolving, the vaccine does not recognize a new strain. Add to that a process known as antigenic shift, by which two or more different strains of a virus can combine to form a new subtype having a mixture of the surface antigens. This is the challenge in making an influenza vaccine. The influenza virus is of two types: Influenza A and B. Of these, type A leads to most pandemics. Companies involved Although seasonal flu vaccines have been adopted enthusiastically in western countries, the concept of a seasonal flu vaccine is yet to take off in India. After the swine flu pandemic in 2009, Indian vaccine companies have risen to the challenge of developing India's own swine flu vaccine and succeeded. Each of the vaccines launched into the India market have some unique technology that differentiates them for the others. Zydus Cadila launched Vaxiflu, which was India's first indigenously manufactured egg-based inactivated vaccine, in June 2010. A month later, Serum Institute of India launched Nasovac, also an egg-based vaccine. The differentiating factor was the unique intranasal method of administration. Also, at the time of its launch, it was the cheapest swine flu vaccine in the market. A few months down the line, Bharat Biotech launched HNVAC, India's first cell culture H1N1 vaccine. The technology involved in a cell culture vaccine allows it to be scaled up in an easier way than egg-based technology. Manasi vaidya in Bangalore ]]> <![CDATA[Exploiting the wonders of nano]]> https://biospectrumindia.com/news/95/2654/exploiting-the-wonders-of-nano.html https://biospectrumindia.com/news/95/2654/exploiting-the-wonders-of-nano.html Wed, 07 Mar 2012 17:30:00 +0530 Nanobiotechnology is offering a vast range of opportunities to the life sciences industry and this is exptected to augment in the future. This field applies the tools and processes to build devices for studying biological systems Genesis On September 13, 2004, the National Cancer Institute launched the Alliance for Nanotechnology in Cancer. This program, initially scheduled to last for five years with $144 million in funding, was designed to develop applications of nanotechnology for cancer diagnosis and treatment. The Technology With nanotechnology, a large set of materials and improved products rely on a change in physical properties when the feature sizes are shrunk. Applications of nanotechnology to medicine and physiology imply materials and devices designed to interact with the body at subcellular (i.e., molecular) scales with a high degree of specificity. This can be potentially translated into targeted cellular and tissue-specific clinical applications designed to achieve maximum therapeutic efficacy with minimum side effects. The Impact New molecular imaging techniques developed by nanobiotechnology are important to probe nano-scale physiological processes in human organs. Such systems help to diagnose diseases at the early stages and to understand the effects of therapies given to the patient. Nanobiotechnology tools help us to understand how cell functions are regulated at the molecular level. Genomics, proteomics, and metabolomics combined with the power of nanobiotechnology will help in understanding the disease, leading to effective and precise targeting. Nanobiotechnology or bionanotechnology is a rapidly advancing area of scientific and technological opportunity that applies the tools and processes of microfabrication to build devices for studying biological systems. Researchers learn from biology to create new micro-nanoscale devices to better understand life processes at the nanoscale. The terms nanobiotechnology and bionanotechnology are often used interchangeably. Nanobiotechnology is essentially miniaturized biotechnology, whereas bionanotechnology is a specific application of nanotechnology. Companies in the field In any business, today's pioneers are tomorrow's leaders. This has led a lot of companies to venture into the nascent field of nanobiotechnology. Dabur Pharma is working on a novel nano-drug delivery system (presently in the advanced stages of development) for Paclitaxel. Because of the better safety and pharmacokinetic profile, the polymeric nanoparticle delivery system is seen as a potential super generic. Micromaterials India is a Bangalore-based company focused on developing innovative nano and micro technologies and materials catalysts for the life sciences industry. NanoBio Chemicals provides high quality nanoparticles using patented technology and also custom synthesizes complex peptides and biochemicals. Moreover, NanoFactor Materials Technologies has a patent pending technology to synthesize carbon nanotubes that have extensive usage in the life sciences domain. Bangalore-based Velbionanotech, which came into existence in 2002, designs drugs for urology, cardiology and neuro diseases with the help of nanotechnology. Some of their product range includes herbal medicine, nano sensors, microDoctor, Nano Material, Nano Medicine and bionanochip. Nanobio Chemicals, based in Mumbai, is engaged in the production of nanoscience education kits, biochemical synthesis and custom peptide, nanocomposites, nanochains, iron oxide nanoparticles and antimicrobial products for food storage, environmental, health and hygiene applications. Furthermore, other companies such as Nanobeach, which is a supplier of nano particles for life science companies, and Bangalore-based Micromaterials are also showing a lot of business potential in the field. Saptarshi Chaudhuri in Bangalore ]]> <![CDATA[The white gold called Bt cotton]]> https://biospectrumindia.com/news/95/1915/the-white-gold-called-bt-cotton.html https://biospectrumindia.com/news/95/1915/the-white-gold-called-bt-cotton.html Wed, 07 Mar 2012 16:48:00 +0530 Most plants on which the world depends for food and fiber lack in-built mechanisms for protection. To protect such plants against pests, insecticides and pesticides are used indiscriminately. Bt technology offers a solution Genesis Bt stands for Bacillus thuringiensis bacterium. It is named after the place Thuringia region of Germany where it was first isolated almost 100 years ago. The first successful use of Bt protein in plants were reported in 1987. Bollgard cotton, developed by Monsanto, was first field tested in 1992. The Technology The cry1Ac protein is produced as an insoluble crystal in the bacteria B thuringiensis. The insecticidal activity of this protein requires that the protein be ingested by the insect and inside the gut, a high-pH environment renders the solubilization of the protein, which is then cleaved to the active form of protein. This active form of protein binds to specific receptors on the midgut of lepidopteran insects, inserts into the membrane and forms ion-specific pores. The digestive tract of non-target organisms do not contain these receptors and thus the protein is non-toxic for them. The Impact India has the the highest-ever hectarage of cotton, 12.1 million hectares in 2011-12. The increase in hectares is credited to the introduction of Bt technology that spurred hybridization, from three Bt cotton hybrids in 2002-03 to 884 Bt cotton hybrids in 2011-12. Consumption of insecticides exhibited a significant drop from 46 percent in 2001-02 to less than 21 percent between 2009 and 2011. The average yield of cotton increased from 308 kg per hectare in 2001-02 to 499 kg per hectare in 2011-12. In India, the Bt technology has been successfully used on commercial scale for cotton till now. The insertion of the Bt gene into the cotton plant cells causes them to produce toxins called crystal (Cry) proteins, which when ingested by the insects kills them. Scientists have identified 60 different strains of Cry proteins that affect a wide variety of insects. Hence, Bt cotton, when compared with conventional non-Bt cotton, offers economic benefits by reducing the investment on insecticides and offering higher yield as compared to the non-Bt cotton varieties. Bt cotton in India The number of events concerning the development of Bt cotton hybrids have increased significantly since 2002. First was Bollgard I (MON531) containing the cry1Ac gene. It was developed by MAHYCO and was approved for sale in 2002. The second event was the development of Bollgard II (MON15985), which too was developed by MAHYCO and featured two genes, cry1Ac and cry2Ab. It was approved for sale in 2006. The third event was the development by JK Seeds featuring cry1Ac gene sourced from IIT Kharagpur. The event was approved for sale in 2006. GFM was developed by Nath Seeds and the gene was sourced from China and featured the fused cry2Ab and cry1Ac. It received approval for sale in 2006. The fifth event known as BNLA-601 was approved for sale in an indigenous publicly-bred cotton variety, Bikaneri Nerma, expressing the cry1Ac gene. It was approved for commercial release in the north, central and south cotton growing zones in India in 2008. This was the first indigenous Bt cotton event developed by the Central Institute of Cotton Research along with the University of Agricultural Sciences, Dharwad, Karnataka. MLS-9124 was developed indigenously by Metahelix Life Sciences and featured a synthetic cry1C gene. In 2009, two Bt cotton hybrids namely MH-5125 and MH-5174 were approved for commercial sale for central and southern zones. The way forward India is the world's most competitive market for cotton seeds. Today, Indian farmers can choose from over 300 hybrid Bt cotton seed varieties with six competing Bt cotton technologies marketed by five technology providers. Vipul Murarka in Bangalore ]]> <![CDATA[Fuel of the future]]> https://biospectrumindia.com/news/95/2391/fuel-of-the-future.html https://biospectrumindia.com/news/95/2391/fuel-of-the-future.html Wed, 07 Mar 2012 16:46:00 +0530 Algae as an alternative source of biofuel can be an effective answer to the escalating price of petroleum and the concern over global warming Genesis Microalgae were first mass cultured on rooftop at MIT during the early 1950s and it was in that project itself that algae biofuels were first spoken of. Between 1980 and 1995, the US DOE-NREL initiated an aquatic species program for microalgae oil production. The Technology A wide range of algae can produce lipids from solar energy, CO2 and appropriate water source. These lipids are stored in lipid vesicles as energy reserves and can comprise up to 60 percent of the dry weight of the algal cell. Both micro and macro algae appear to be a major source that can sequester high level of CO2 and can replace fossil fuels. Biodiesel production from algae is done through screening and isolation of strains with high growth rate and high oil content using various techniques. The Impact With the current worldwide focus on cleaner fuels and environmental awareness, algal biodiesel is an attractive option. Specific production of oil per unit of biomass is extremely high in algae as compared to other seed crops. When compared with the current biodiesel technologies that utilize food crops, algal technology can prove to be a major boost. Breakthroughs in this area can contribute to the country's commitment to reduce its carbon emissions. With energy consumption increasing and the finite sources of fossil fuels diminishing, algal biofuels can be an alternative solution if they meet the same commodity standards of price, quality and service. It can prove to be a cheaper source of biofuel as specialized algae for production of one million gallon of biodiesel per year requires less than 100 acres of land, whereas other sources such as jatropha and soybean need 4,500 acres and 16,000 acres of land, respectively. About $1 billion has been spent globally till now for developing algal biofuel. In 2010, the US Department of Energy announced $80 million in funding for research on algae-based biofuels. Japan too is geared up for the production of micro algae. In China, government support is mainly through policy to algae biofuel projects. South Korea has invested $275 million for developing bioenergy from algae. In India, research institutes, including Council for Scientific and Industrial Research (CSIR) labs, have been working on algae biofuels. For a green future India has a great potential in algae biofuel as it can make use of 7,000 km of its coastal line. A joint scientific project by nine laboratories of the CSIR has been testing biodiesel sourced from microalgae growing naturally in India's west coast. The nine-laboratory consortium, with Central Salt and Marine Chemicals Research Institute (CSMCRI) as the nodal lab, recently tested a biodiesel mix (20 percent biofuel, 80 percent petroleum) produced from microalgae. Moreover, other marine microalgal strains, especially those with high lipid productivity, are being investigated under the project. The Marine Biotechnology Laboratory, University of Delhi, led by Dr Dinabandhu Sahoo, scientist, developed and implemented the first coordinated project on large-scale algae cultivation in India, with the help of the Department of Science and Technology, Government of India. Chennai-based Sea6 Energy is also working on the production of red seaweeds (macro algae). The company has already proved on lab scale that ethanol can be produced from red seaweed and is now looking forward to set up pilot facilities to demonstrate this. The company, in partnership with Bangalore-based Noyozymes, is looking for a solution to its need for enzymes to hydrolyze carbohydrates to monosaccharides. It is looking for the enzymes that can work commercially in the salt water system, which otherwise is very corrosive. Another company based in New Delhi, AquaAgri, is into the cultivation of seaweeds at mass scale. The company produces and supplies raw materials to the biofuel industry depending on requirement. Rahul Koul in New Delhi with inputs from Vipul Murarka ]]> <![CDATA[Decoding the human genome]]> https://biospectrumindia.com/news/95/2105/decoding-the-human-genome.html https://biospectrumindia.com/news/95/2105/decoding-the-human-genome.html Wed, 07 Mar 2012 16:44:00 +0530 Next generation sequencing has created amazing opportunities in the biological sciences as sequence generation is no longer a bottleneck for biologists Genesis The original sequencing methodology, known as Sanger chemistry, uses specifically labeled nucleotides to read through a DNA template during DNA synthesis. Shotgun sequencing was developed during Human Genome Project, in which genomic DNA is enzymatically or mechanically broken down into smaller fragments and cloned into sequencing vectors in which cloned DNA fragments can be sequenced individually. The complete sequence of a long DNA fragment can be eventually generated by these methods by alignment and reassembling of sequence fragments based on partial sequence overlaps. The Technology New NGS technologies read the DNA templates randomly along the entire genome. This is accomplished by breaking the entire genome into small pieces, then ligating those small pieces of DNA to designated adapters for random read during DNA synthesis (sequencing-by-synthesis). Therefore, NGS technology is often called massively parallel sequencing. The Impact Questions that biologists have sought to answer for decades but were unable to address because of lack of appropriate technologies can now be addressed with NGS. It has become easier and quicker to map genes for diseases that are caused due to alterations in one or a few genes. Next Generation Sequencing (NGS), also called second generation sequencing, is a term that has come to mean post-Sanger sequencing methods. It has become a shorthand for large amounts of data being generated at incredibly low costs. The initial sequencing of the human genome took around 13 years, an international consortium of researchers and close to 13,500 crore ($2.7 billion) to complete. Since then, sequencing technology has so evolved that a consumer can have his or her entire genome sequenced in a matter of days for less than 4 lakh ($8,000). In India, not many companies are working in the field. However, there is immense scope. Professor Partha P Majumder, director of National Institute of Biomedical Genomics and TCG-ISI Center for Population Genomics, Kolkata, and head of the Human Genetics Unit, ISI, Kolkata, says, â€œI think India can jump into NGS-related R&D and soar high. Many organizations have actually taken the leap, but I would like to see more organizations getting involved in NGS-related R&D. The community of scientists engaged in NGS R&D is small in India, therefore, there is very little scope of dialogue and argumentation on NGS.â€? Although NGS has immense potential, there seems to be several concerns and challenges associated with it, including lack of appropriate statistical methods and analytical pipelines to draw valid and generalizable inferences from the NGS data; lack of storage; lack of robust methodologies for data analyses and high error rates, particularly in regions of sequence complexity. These concerns have paved the way for the emergence of a new generation of sequencing technologies. Working on NGS Roche is active in this field with its GS-FLX 454 Genome Sequencer, which was originally called 454. Illumina is also at the forefront with its Genome Analyzer, which was originally with Solexa Technology. Dover has created the Polonator G.007 in collaboration with the Church Laboratory of Harvard Medical School. Furthermore, Helicos BioSciences and Applied Biosystems are also contributing to NGS with their HeliScope platform and SOLiD sequence alignment, respectively. The companies use a single or a combination of technologies, such as microfluidic DNA sequencing, polony sequencing, millikan sequencing by nucleotide, single-molecule DNA sequencing with engineered nanopores. Saptarshi Chaudhuri in Bangalore ]]> <![CDATA[The great mAbs race in disease therapy]]> https://biospectrumindia.com/news/95/1938/the-great-mabs-race-in-disease-therapy.html https://biospectrumindia.com/news/95/1938/the-great-mabs-race-in-disease-therapy.html Wed, 07 Mar 2012 16:32:00 +0530 The technology has been lapped up by the scientific community due to the technical superiority of its targeted therapeutic mechanism Genesis Dr Paul Ehrlich postulated that if a compound could be made to selectively target a disease-causing organism, then a toxin for that organism could be delivered along with the agent of selectivity. In 1988, Greg Winter and his team pioneered the techniques to humanize monoclonal antibodies. The Technology Monoclonal antibodies are monospecific antibodies (antibodies that have an affinity for the same antigen) because they are made by identical immune cells that are all clones of a unique parent cell. It is possible to produce monoclonal antibodies that specifically bind to almost any substance. They can then serve to detect or purify that substance. They directly target the specific disease afflicted cells, thus reducing a large array of side effects. The Impact An analysis by GBI Research estimated the global monoclonal antibodies market to be valued at $15.6 billion in 2010. The market is forecast to grow at a CAGR of 10.6 percent between 2010 and 2017 and to reach $31.7 billion by 2017. There were at least six new mAbs under regulatory review and 100 in phase II clinical trials. In the year 2012, the world will see a greater impact of this technology with dwindling pipelines and patent expirations. By 2018, over $10.6 billion worth of mAbs will lose patents and will be a focus of many pharma and non-pharma companies. Designated as the medicine of the 21st century, the monoclonal antibodies (mAbs) segment represent the second wave of innovation in biotechnology following the success of recombinant proteins. Over the past two decades, since the first mAb product was commercialized in the market (Johnson & Johnson's Orthoclone OKT3 in 1986), the technology has been lapped up by the scientific community due to the technical superiority of its targeted therapeutic mechanism. Unlike other defense mechanisms in combating diseases, it directly targets and destroys the afflicted cells using the human body's immune system, thus reducing toxicity levels and side effects often associated with chemical-based drugs. This is applicable for diseases such as oncology, arthritis, inflammation and immune disorders. For example, conventional treatments of cancer through chemotherapy and radiation therapy often result in relapse and patients ultimately die either from their cancer or due to toxicity of the therapy. mAbs are designed to demonstrate efficacy with low toxicity and are expected to reduce overall treatment and hospitalization costs. Companies in pursuit Globally, the mAbs market so far has been dominated by the big four companies: Roche, Genentech, Johnson & Johnson and Abbott. Growing at a compound annual growth rate of around 36 percent, the market is dominated by the big five blockbuster products: Avastin and Herceptin (for oncology); Humira and Remicade for autoimmune and infectious disease (AIID); and Rituxan for oncology and AIID. The commercial success of these products prompted many Indian companies to make an aggressive foray into this space. Biocon and Dr Reddy's Laboratories have commercialized their mAbs products in the India market. Biogen Idec, Amgen, Novartis, UCB Pharma, Bristol-Myers Squibb and Sanofi-aventis too plan to expand their presence in the market. In India, Intas Biopharma (now integrated into Intas Pharma) has invested 160 crore into a facility dedicated to mAbs in a memorandum of understanding with the Government of Gujarat. Other companies in the race are Serum Institute of India, Bharat Serums and Vaccines and Avesthagen. However, there are challenges associated with the technology as mAbs are complex protein molecules and often there is a carbohydrate moiety attached to them. Characterization of such complex molecules is a challenge. Nayantara Som in Mumbai ]]> <![CDATA[Holy grail of the future]]> https://biospectrumindia.com/news/95/2022/holy-grail-of-the-future.html https://biospectrumindia.com/news/95/2022/holy-grail-of-the-future.html Wed, 07 Mar 2012 16:19:00 +0530 Manipulating the cord blood cells that have been collected during birth in order to increase their numbers is viewed by the scientific community as the way forward for the future Genesis In 2010, scientists at the Fred Hutchinson Cancer Research Center cleared a major technical hurdle in making umbilical cord blood transplants, a more widely-used method for treating leukemia and other blood cancers. The successful laboratory method for expanding the number of stem and progenitor cells from a single unit of cord blood resulted in an average 164-fold increase in the number of CD34+ cells, a type of hematopoietic stem cell. Such cells are multi potent and give rise to all types of blood cells. The Technology Human cord blood stem cells that are collected and stored during birth are limited in quantity due to which patients in their lifetime can utilize these cells for limited number of times. Cord blood cell expansion technologies open up the scope for multiple use of these cells for a variety of treatments and increases the capacity of transplantation both in adults and adolescents. The Impact Manipulating cord blood stem cells in order to increase their numbers, will result in treatment using the patient's cord blood cells for a wide variety of diseases. Moreover, it reduces the risk of early deaths when patients opt to get treated through cord blood cell transplantation. It would also allow those families who have privately banked their cord blood stem cells to use them for multiple treatments and even potentially donate a portion of their cord blood sample to patients who are in need. The technology of human cord blood cell expansion, wherein stem cells can divide, multiply and increase in numbers, is slated by scientists across the world as an important treatment tool of the future. Using this technology, patients can use their cord blood cells a multiple number of times for more than one treatment during their lifetime, thus improving treatment outcomes. It could also lead to multiple use on patients. Cord blood cells are stored both in public and private stem cell banks. While private banks store cord blood cells such that in the future it can be used by the same person, public banks store it based on the same human leukocyte antigens (HLA), which could be used by any needy person with the correct HLA match. Dr Samuel Abraham, director, Nichi-In Center for Regenerative Medicine (NCRM), Chennai, says, â€œIf someone needs a cord blood transfusion for some disease, the patient will have to look for a fully matching cord blood unit available with a public cord blood bank and in that case if there are 30,000 samples already stored in that particular bank, the chances of getting one fully matching unit is good.â€? Even if a matching unit is available, the quantity may be or may not be sufficient and the same unit may be needed for one or more people. Cord blood, which has 300-to-600 million cells, will be adequate for a patient with a body weight of 10-to-20 kgs. Beyond that, more than one cord blood unit of the same HLA typing is necessary. This is when expansion of a patient's cord blood cells becomes vital, especially in the Indian context. Companies in pursuit Globally, many research and clinical studies are underway focusing on cord blood cell expansion techniques, which is indicative of the significance this technology will hold in the future. Chennai-based Indo-Japan joint venture Nichi-In Center for Regenerative Medicine is presently conducting extensive research on the technology through in-vitro methodologies. National Center for Cell Science, Pune, is also making progress in studies and research towards expansion of cord blood stem cells. Researchers here have used anti-apoptotic agents as supplements in media for in vitro expansion and cryo preservation of expanded CD34+ cells and see that they reduce apoptosis and enhance expansion. It is predicted that this technology will open new doors for diseases such as leukemia. Nayantara Som in Mumbai ]]> <![CDATA[The technology that started it all]]> https://biospectrumindia.com/news/95/2509/the-technology-that-started-it-all.html https://biospectrumindia.com/news/95/2509/the-technology-that-started-it-all.html Wed, 07 Mar 2012 16:15:00 +0530 The underlying principles in all major biotech processes can be traced back to recombinant DNA technology, which was first invented in the 1970s Genesis Dr Stanley Cohen and Dr Herbert Boyer published a series of papers in 1973-74 on the process by which pieces of DNA could be transferred between organisms using splicing enzymes. In December 1980, patents on gene cloning were issued to Stanford University and the University of California, where they taught. The Technology Recombinant proteins are produced by transferring a human gene to an expression system. The human gene is isolated and then ligated or joined to a piece of plasmid vector, a piece of DNA that can replicate independently. Plasmids naturally occur in bacteria and hence can easily be transferred to a suitable host. The protein which is transferred also needs to be ligated with a promoter or a piece of DNA, upstream, from the host cell that will induce the production of that protein. When the host reproduces, the protein gene is replicated along with the plasmid. The Impact Prior to the advent of recombinant DNA technology, proteins for treating disorders had to be obtained from either cadavers or animal sources. These methods were unsafe and extremely difficult to be adapted on a large scale. Also a subset of patients existed who would develop allergies to the foreign insulin. Today, the global market for recombinant insulin alone is $14 billion with the global insulin market forecasted to grow at the rate of 20 percent during 2010-15. In 1973, when two scientists proposed a mechanism to combine DNA from two different organisms, not only did they give rise to a new technology but also invariably laid the foundation for the entire biotechnology industry. Today the underlying principles of all major biotech processes, ranging from recombinant proteins to vaccines to Bt Cotton, can be traced back to the recombinant DNA technology, discovered by Dr Stanley Cohen and Dr Herbert Boyer. The best way to describe recombinant DNA technology is that it is essentially a cut and paste mechanism that involves isolating parts of DNA from different organisms using enzymes (called restriction enzymes), and then joining them together to get recombinant DNA (by using a class of enzymes called ligases). These restriction enzymes allow for the DNA to be cut in such a way that their ends can be joined with foreign DNA. The resultant recombinant DNA can be expressed in another host organism such as a bacteria or yeast. On replication, the organism produces a recombinant protein that would not have been produced under natural circumstances. The recombinant protein is similar in nature to the natural protein, but can be produced in large quantities in the host organism. Initially, the lack of understanding of the technology led to criticism and false scares of genetically modified monsters in the making. However, once it became possible to produce a recombinant protein, several human disorders arising out of protein deficiencies could be treated more easily. With this, production of therapeutic proteins, such as insulin for diabetes, human growth hormone for pituitary gland disorders, erythropoietin for anaemia, factor VIII for hemophilia and many more can be done easily on a large scale and made available to the common man. Similarly, recombinant antigenic proteins for producing vaccines and recombinant insect proteins for GMOs could be produced. Today this technology has spread to such an extent that it is in use everywhere from university labs to large biotech companies. In India, since the last two decades, a number of companies such as Biocon, Transgene Biotek, Virchow Biotech, Bharat Serums and Vaccines and Shreya Life Sciences are producing recombinant proteins and biopharmaceuticals. Manasi Vaidya in Bangalore ]]> <![CDATA[India's biotech innovators need some help]]> https://biospectrumindia.com/news/95/1011/indias-biotech-innovators-need-some-help.html https://biospectrumindia.com/news/95/1011/indias-biotech-innovators-need-some-help.html Mon, 20 Feb 2012 16:20:00 +0530 More than two decades ago, India's health administrators, nudged by civil society and concerned scientists, embarked on a national mission to eradicate the dreaded polio disease that crippled millions of young lives every year. A large number of public and private vaccine manufacturers stepped in to make the polio vaccines available in plenty at reasonable costs. Thanks to a multi-pronged strategy, India has been declared â€œpolio-freeâ€? as not a single case of polio occurred in the country in 2011. If this situation continues for two more years, polio will join the list of diseases eradicated in the country. The polio eradication taught the nation and its vaccine industry many things. Thanks to generous support from Rotary International and other international voluntary and UN agencies, Indian companies got the know how to build polio and other vaccines. The seed sown by this initiative has led to the emergence of a thriving vaccine sector in India. In fact, belying all expectations, India's vaccine industry has become a leader in global supply of many critical vaccines. As pointed out by Dr M K Bhan, secretary, Department of Biotechnology (DBT), recently, India today supplies more than half of the world's pediatric vaccines to the global supply system, run by UN agencies. Can the nation build on the momentum and continue to innovate in the healthcare space? Can India's innovators continue to learn from international best practices that reached the country through collaborative arrangements? Some recent developments appear to throw a spanner in the drug innovation ecosystem. Companies in the clinical trial sector have been complaining about the slow regulatory process that has come in place in the light of malpractices by a few players in recent years, affecting the entire industry. New clinical trial approvals are taking more than 18 months and there is a sense of despondency building up in the industry. Such a situation has long term consequences because the decade-old clinical trial industry in the country has played a key role in stimulating the drug innovation system in the country indirectly. The elaborate protocols followed by global companies who used India as a site for their clinical trials have transferred a lot of expertise to Indian professionals. This may soon come to a stop. The chief of world's largest clinical trial company, Quintiles has indicated that the company's future projects will move to China to ensure business process continuity, affected in India by the delayed regulatory process. In fact, Quintiles' global CEO Dennis Gillings during his recent India visit has appealed to the Indian government to look at the industry for its overall beneficial effect. There is a merit in his argument. What is the point in tarring a whole industry for the faults of a few errant companies. After all, despite widespread complaints about the safety standards of two of the country's leading airlines, the entire civil aviation industry has not been made the scapegoat and stymied by regulators. Why should clinical trial sector be treated differently? It is not all gloomy though for the industry. Three bioscience leaders - Dr Swati Piramal of Piramal Life Sciences, Mumbai, Dr V Mohan of M V Diabetes Research Center, Chennai, and Dr V S Chauhan of ICGEB, New Delhi, have been conferred the national civilian award, the Padma Shri, by the government this year. Our industry should be honored by this gesture whereas not a software or communication industry representative made it to the Padma Awards list this year. Narayanan Suresh Chief Editor sureshn@cybermedia.co.in ]]> <![CDATA[Padma Shri for four industry stalwarts]]> https://biospectrumindia.com/news/95/6217/padma-shri-for-four-industry-stalwarts.html https://biospectrumindia.com/news/95/6217/padma-shri-for-four-industry-stalwarts.html Mon, 13 Feb 2012 15:14:00 +0530 Dr Swati A Piramal, director, Strategic Alliances & Communications, Piramal Healthcare; Prof Virander S Chauhan, director, International Centre for Genetic Engineering & Biotechnology (ICGEB), New Delhi; Dr V Mohan, noted diabetologist from Chennai and Dr Nitya Anand, former director of Central Drug Research Institute (CDRI), Lucknow, have been bestowed the Padma Shri award this year for their contributions to the science and technology industry. The list of 77 awardees was announced on the eve of Republic Day as per the tradition. The award carries a medal, a scroll of honor and a cash prize of 5 lakh. Padma Shri is the fourth highest civilian award in India after Bharat Ratna, Padma Vibhushan and Padma Bhushan. The awards will be conferred by the President of India at a function held at Rashtrapati Bhawan in March or April, 2012. Prof VS Chauhan currently heads the ICGEB, New Delhi. He has also won the BioSpectrum Person of the Year Award 2011. He is well-known for his work in the area of design, synthesis and utility of conformationlly-defined peptides and is the founder president of the Indian Peptide Society. â€œIt feels really good to be recognized for one's work. I am grateful to the mentors from whom I have drawn inspiration, and to the large number of students and colleagues who have contributed to my work,â€? Prof Chauhan said. â€œTo young students and colleagues, I can say that there is no substitute for hard work. Keep at it and remain focused at all times. And, read extensively.â€? Dr Swati A Piramal, director, Strategic Alliances & Communications, Piramal Healthcare, apart from taking her company to the heights of success along with her husband Mr Ajay Piramal, has also made significant contributions to the industry. She was the first woman to be elected president of ASSOCHAM in 2009. She is a member of the Board of the Council of Scientific and Industrial Research and an expert member of the Planning Commission, Government of India. She is also the spokesperson of a nationwide public health campaign against chronic disease launched by former president of India Dr APJ Abdul Kalam in 2008. Dr V Mohan, diabetologist from Chennai, brings with him 30 years of experience in the field of diabetes research. He is working towards expanding diabetes healthcare services in rural India. â€œMy message to the youngsters in India interested in this field is that more work should be actively pursued in the field of diabetes research, especially translational research work,â€? he said. â€œI am extremely happy to receive this award and it is an honor that my work in the field of diabetes research has been recognized.â€? Dr Nitya Anand, former director of CDRI in Lucknow, was involved in carrying out some pioneering work on pharmaceutical sciences. In 2005, Indian Pharmacopoeia Commission appointed him chairman of its scientific committee. Currently, he is the chairman of the Ranbaxy Science Foundation. ]]> <![CDATA[PM: More investment in R&D needed]]> https://biospectrumindia.com/news/95/1196/pm-more-investment-in-rd-needed.html https://biospectrumindia.com/news/95/1196/pm-more-investment-in-rd-needed.html Mon, 13 Feb 2012 15:13:00 +0530 On the occasion of 99th annual session of the Indian Science Congress in Bhubaneshwar, the Prime Minister of India, Dr Manmohan Singh, emphasized the need for increasing public-private partnerships and catalyzing increased interaction between publicly owned science and technology institutions, and the industry. Recognizing the various problems plaguing the research community such as lack of employment opportunities, especially for women scientists, Dr Manmohan Singh pointed out that a recent survey revealed that 60 percent of nearly 2,000 Indian women PhDs in science were unemployed for lack of job opportunities. Dr Singh also highlighted that public investment in R&D has been growing at 20-to-25 percent every year during the 11th Five Year Plan period (2007-12). Over the last few years, the number of scientific publications by Indian scientists working in India increased at more than 12 percent per annum as compared to the global average of four percent. India has moved from 15th rank in 2003 to ninth rank in 2010, with respect to the number of publications in peer-valued journals. Dr Singh notably singled out the pharmaceutical industry for creating a world-class hub for advanced technology. He further implored other industries to emulate that example. He also called for greater investment in R&D, including funding by the industry and other strategic sectors. The total R&D spending as a percentage of GDP is expected to be at least two percent by the end of the 12th Five Year Plan period, from the current level of about one percent. He pointed out that this could only be achieved if the industry, which contributes about one-third of the total R&D expenditure, increases its contribution significantly. Orchid Pharma completes phase I study Chennai-based global pharma major, Orchid Chemicals and Pharmaceuticals, successfully completed phase I trial of its orally administered PDE4 (phosphodiesterase 4 inhibitor) molecule OCID 2987 positioned for the treatment of inflammatory disorders, including chronic obstructive pulmonary disease, in Europe. It was found that OCID 2987 is well-tolerated up to the highest doses administered in both single and repeat dose studies and did not demonstrate a potential for nausea or emesis, a common unacceptable side-effect with most PDE4 inhibitors. There were no serious adverse events or any cardiac safety concerns reported in the study. Orchid's drug discovery efforts are conducted through its wholly-owned subsidiary Orchid Research Laboratories. Artemisia annua trials get nod Jamia Hamdard University received go-ahead from the Genetic Engineering Approval Committee (GEAC) to conduct event selection trials on Artemisia annua L (sweet worm) transgenic lines. The same has been developed in an institute-industry collaborative research project sponsored by the DST-DPRP, by IPCA, Mumbai, and Faculty of Science, Jamia Hamdard, New Delhi. With respect to IPCA Labs, the GEAC has recommended constitution of Institutional Biosafety committee (IBSC) and resubmission of the application subsequent to receipt of minutes of the IBSC meeting. Online research funding procedure The Indian Council of Medical Research (ICMR) put in place a new revised procedure for processing extramural research projects. The revised procedure, which has come into effect since Jan 01, 2012, makes it mandatory for investigators to submit a concept note to describe the justification and objectives of the study, expected outcomes, benefits, proposed methodology, duration of the project and tentative budget. The investigators may look into the thrust areas of research of the council, which are based on national needs and are available on the ICMR website, while preparing the concept note. After receiving the concept note, which can be submitted during any time of the year, an acknowledgment will be issued that will have an unique identification number (Id No). The procedure requires all future correspondence and sanctions to have this number. The concept proposals received within two months blocks or on deadline would be scrutinized and evaluated by the council within a fixed time period. Decision would be communicated to investigators for both selected and non selected proposals. Only the principal investigators (PIs) of the selected concept notes would be asked to expand their proposal into detailed project in the format of the ICMR adhoc projects within a period of not more than two months and submit to the council online. The detailed project will also be evaluated by the council within a fixed time and decision. ]]> <![CDATA[Strides subsidiaries get FDA approvals]]> https://biospectrumindia.com/news/95/1206/strides-subsidiaries-get-fda-approvals.html https://biospectrumindia.com/news/95/1206/strides-subsidiaries-get-fda-approvals.html Mon, 13 Feb 2012 15:12:00 +0530 The sterile products manufacturing facility (SPD 1) of Agila in Bangalore, which was recently inspected by the US FDA as part of the routine GMP compliance audit, has been classified as acceptable. Agila Specialties is the specialties unit of Strides Arcolab, which was spun off as a separate division following the company's restructuring in 2009. It is focused on key domains such as oncolytics, penems, pencillins, cephalosporins, ophthalmics, peptides and biosimilars and operates from eight world class global manufacturing facilities, including one of the largest sterile capacity in India and amongst the largest lyophilization capacities in the world. Another subsidiary of Strides Arcolab, Onco Therapies, received an approval for fludarabine phosphate. It is a part of the oncology portfolio licensed to Pfizer in January 2010 for the US market. Fludarabine injection is used to treat chronic lymphocytic leukemia in adults who have already been treated with at least one other medication and have not gotten better. Transparent regulatory system soon The Ministry of Science and Technology (S&T), India, besides working on a fresh S&T policy, is also looking at increasing the R&D spending from the current one percent to two percent of the gross domestic product (GDP). This was revealed by Science and Technology Minister Mr Vilasrao Deshmukh at the 99th Session of Indian Science Congress. Mr Deshmukh further highlighted that India needed big ideas in science, new methods in governance of R&D systems, right investment of resources, aspiration to emerge as world leader in science and dedication to serve the people of India through the tools of technology and affordable innovations. He is hopeful that India will emerge as a major player in science before the end of 2017. The minister called for paradigm shift in the mindsets from 'developing policy for science' to 'developing science policy for people'. Curb on stem cell transplants The National Apex Committee for Stem Cell Research and Therapy (NACSCRT) has made it mandatory for stem cell transplants to be registered on clinical trials registry. The commitee has determined that only hematopoietic stem cell transplants for blood diseases and limbal stem cell transplants for corneal diseases can be performed as standard therapy outside of clinical trials in India. The committee also made it mandatory that all other forms of stem cell transplants, including those with blood or marrow derived stem cells, cord blood stem cells, mesenchymal stem cells and any embryonic stem cell derived tissue should only be used within an appropriately reviewed and monitored clinical trial that has been registered on the ICMR clinical registry. Indian institutions will have to send the information pertaining to their Institutional Committee for Stem Cell Research and Therapy as per format to the member secretary, NACSCRT. GEAC rethinks NOC on GM trials In view of the constraints in getting clearance from the state governments for conducting GM crops field trials, the Genetic Engineering Appraisal Committee (GEAC) may reconsider its earlier decision on the requirement of no objection certificate (NOC) from states for these research trials. On the basis of detailed deliberations, the committee concluded that the issue of non-issuance of NOC by state governments is mainly due to lack of awareness on highly technical issues associated with biotechnology and biosafety measures. However, the committee reiterated that the role of the state government is very critical for compliance monitoring and, therefore, it is important to have a dialogue with the state government to provide necessary clarification. TDR-TB to be investigated The Ministry of Health and Family Welfare sent a central team of doctors to Mumbai to ascertain facts about the reported cases of drug resistant tuberculosis cases. The ministry pointed out that Hinduja Hospital's lab is not accredited by the Revised National Tuberculosis Control Programme (RNTCP), for culture and sensitivity of second line drugs to diagnose extensively drug-resistant (XDR) or total drug resistant (TDR) cases. It is only accredited for conducting drug susceptibility testing (DST) by liquid culture and sensitivity for first line drug. Preliminary results of second-line DST for MDR-TB patients from DOTS plus sites and also isolates collected from Gujarat and Maharashtra drug resistance surveys show that there is not yet any XDR-TB amongst new cases and around 0.5 percent amongst re-treatment cases. ]]> <![CDATA[ISO certification for Semler Research Center]]> https://biospectrumindia.com/news/95/2610/iso-certification-for-semler-research-center.html https://biospectrumindia.com/news/95/2610/iso-certification-for-semler-research-center.html Mon, 13 Feb 2012 15:11:00 +0530 Semler Research Center (SRC), a leading Indo-US based clinical research organization (CRO), has been awarded International Standards Organization's (ISO) 9001:2008 and ISO 27001:2005 certification in recognition of its standardized best practices and effective IT infrastructure deployment for data security across the organization. The move comes as SRC looks to leverage on domestic and international expertise to embrace global standards of service provision in compliance with applicable regulatory requirements to further its business objectives and scientific goals, and provide superior quality to its sponsors. The scope of the registration includes bio-availability and bio-equivalence, clinical development, scientific and medical writing, and pharmaceutical development services. Speaking on the occasion, Dr Krathish Bopanna, president and executive director, said, â€œThe ISO 9001 certification is a guarantee of our excellence in service and will certainly reinforce our credentials as a leading CRO. This achievement of certification confirms our commitment to quality and meeting the requirements of customers resulting in customer satisfaction without compromising the regulatory requirements.â€? Quintiles invests in cancer company Quintiles invested in a new company, Oxford Cancer Biomarkers, that provides oncology consulting services and new cancer biomarkers, the key to scientific selection of the right drug for the right patient. Oxford Cancer Biomarkers will develop biomarkers using CancerNav, a proprietary DNA and protein-based assay technology platform, invented by Mr Nick La Thangue, chair of Cancer Biology at Oxford University. Mr David Kerr, professor of cancer medicine at the University of Oxford and a world-renowned expert in cancer clinical research and policy development, will serve as the new company's chief medical officer. Quintiles is the largest shareholder in Oxford Cancer Biomarkers. The other major shareholders are the University of Oxford and professors La Thangue and Kerr. ICON in partnership with Shire Pharma ICON, a global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries, signed a strategic partnership with Shire Specialty Pharmaceuticals to serve as the sole global provider of central laboratory services and one of the two strategic partners for clinical development services. As a partner for clinical development, ICON will provide Shire with a full range of services, including site and country feasibility, ethics and regulatory submissions, clinical trial monitoring, project management, site and study team support, medical management and medical data review. Shire will also utilize ICON Central Laboratories' extensive test menu from its global network of laboratories. Clinical trial to begin for Sumagen's HIV vaccine Omnia Biologics' customer Sumagen will begin clinical trials of their revolutionary HIV vaccine design. The Food and Drug Administration-approved phase I clinical trial will begin in early 2012. The design and testing of the vaccine was spearheaded by Dr Chil-Yong Kang, a professor at the University of Western Ontario's medical school. Dr Dale Vander Putten of Omnia Biologics, said, â€œTo date, experimental HIV vaccines have been largely either subunit vaccines or used non-HIV vaccine vectors and have universally failed in the clinic.â€? Dr Kang and his team took a page from the successes of polio, flu, rabies and other highly effective vaccines focusing instead on a viral vaccine that is genetically attenuated, irradiated and chemically inactivated,â€? he said. Omnia, a drug development and manufacturing services provider, participated in the international effort to propel this important advance into the clinic by providing process and assay development services, and manufacturing the vaccine under GMP for South Korean biotech company Sumagen and their academic partner Dr Kang and UWO. Preclinical testing has shown the vaccine to be safe and produce strong immune responses. Mr Steve Hubert, vice president of operations at Omnia, said, â€œIt is especially heartening for our team at Omnia to be able to translate this important technology into the clinic as other well established contract manufacturers failed in their attempts to produce the vaccine at clinical scale.â€? ]]> <![CDATA[Cryo-Save India gets AABB accreditation]]> https://biospectrumindia.com/news/95/1348/cryo-save-india-gets-aabb-accreditation.html https://biospectrumindia.com/news/95/1348/cryo-save-india-gets-aabb-accreditation.html Mon, 13 Feb 2012 15:10:00 +0530 Cryo-Save India has received the prestigious American Association of Blood Banks (AABB) accreditation. The AABB accreditation follows an intensive on-site assessment by specially trained AABB assessors and establishes that the level of technical and administrative performance within the facility meets or exceeds the standards set by the AABB. It qualifies the viability of the sample processed and stored at the Cryo-Save lab to be used in a transplant any time in the future. The AABB is an international non-profit body dedicated to developing the highest standards in blood and cord blood banking, transfusion medicine and cellular therapy. Napo secures dismissal of legal action In a new development in the Napo-Salix crofelemer legal issue, Napo Pharmaceuticals won a legal dispute with Salix Pharmaceuticals in which Salix had sought access to Napo's financial books and records. Napo had argued the action was completely without merit. The motion to dismiss seeks a dismissal of Salix's own lawsuit with prejudice and, therefore, will bar Salix from pursuing the same claims in the future against Napo. Napo also filed an amended law suit against Salix, which is pending in the Supreme Court of the state of New York. The complaint claims Salix breached its contract with Napo and seeks damages for the alleged failure of Salix to use â€œcommercially reasonable efforts to develop and commercialize crofelemerâ€?, a first-in-class novel drug compound. The lawsuit seeks tens of millions of dollars in damages. On November 4, 2011, Napo terminated its collaboration agreement with Salix to commercially develop crofelemer. The compound is a treatment for diarrhea, a life-threatening ailment, which impacts millions of people across the world. Span MD gets ET NOW-IndiaMART award Mr Veeral Desai, managing director, Span Diagnostics, recently received the 'ET NOW IndiaMART Leaders of Tomorrow' award in Mumbai. Mr N R Narayana Murthy, chairman emeritus, Infosys Technologies, presented the award to the winner under pharmaceuticals and medical category and appreciated his contribution to fortify the MSME ecosystem with relentless efforts and creativity. Mr Veeral Desai said he believed in strategic management processes that revolve around the main focus of the company, including innovation and creativity. The company develops and manufactures a comprehensive range of indigenous ready-made diagnostic products that are needed by various segments of healthcare. CPL Biological facility in 4 months CPL Biologicals, a joint venture between Novovax and Cadila Pharmaceuticals, has begun construction of a state-of-the-art manufacturing facility that will be used to produce pandemic and seasonal influenza vaccines. The CPL Biologicals facility is expected to be operational within four months and should be capable of producing over 60 million doses annually at full capacity. Novavax retains rights to products developed for markets outside India. CPL also expects to develop the pandemic H1N1 influenza vaccine candidate in India that Novavax is developing in the US. Microbix, Zydus enter deal Microbix Biosystems and Zydus Cadila have signed a letter of intent to market the thrombolytic drug, Urokinase, in the North American markets. The anticipated timeline for approval is late 2014. Microbix will receive a milestone payment upon reaching a certain sales target, will get a margin and also earn a royalty fee based on sales. Zydus will receive an option on the rights to all future indications, including in the areas of oncology and ophthalmology. The estimated market size for Urokinase use in the US is expected to touch $400 million by 2020 between three indications, pulmonary embolism, catheter clearance and catheter prophylaxis. Zydus Pharmaceuticals US is ranked 12th among the top generic companies in the US. Barcoding to reduce counterfeit drugs Close on the heels of the Drugs Controller General India's (DCGI) notification on mandatory barcoding for export of pharmaceutical products, Activecubes, an analytics driven company, will soon introduce a service to pharmaceutical companies to enable them and the consumer to differentiate counterfeit drugs from authentic ones. It has been estimated that up to 30 percent of the drugs sold in the domestic market could be spurious. Furthermore, the counterfeit drug market said to be more than $75 billion worldwide. This not only presents a significant health hazard but also spells a major revenue loss to pharma companies, not to mention the hit that the brand takes. Mr Rajesh Varrier, founder and CEO of Activecubes, said, â€œWe have developed a proprietary platform to generate a unique identification number at the strip or vial of the drug. On purchasing the drug, the end user can send an SMS of that unique number to a telephone number specified on the pack. The user would then be informed immediately if the drug purchased was genuine or not.â€? Conservative estimates state that there are over 700 million mobile users in India, which makes this solution accessible to a large population in our country. In addition to the unique identification number, Actrivecubes also hopes to make use of QR codes, which can be read by mobile applications in advanced phones in the future. Bharat Biotech's vaccine supply suspended As a part of the evaluation of new pre-qualification applications of two vaccines types, the World Health Organization (WHO) after conducting a site audit in September 2011 at the Bharat Biotech production plant in Hyderabad, found deficiencies in the implementation of good manufacturing practices and in the quality management system of the company. The observations had potential implications beyond the directly audited products for the hepatitis B vaccine (Revac-B+) and three formulations of oral polio vaccines (OPV) that are already on the list of vaccines prequalified by WHO for supply to countries through UN procurement. As the manufacturing locations for the currently pre-qualified products hepatitis B and OPV vaccines were not audited in September 2011, the WHO has been requested by the ad hoc expert committee to conduct another site audit before making a final decision on all these products. In the interim, the WHO has suspended supply of hepatitis B vaccine from the company through United Nations (UN) procuring agencies. The WHO has not recommended recall of Revac-B+ already distributed, since the suspension is precautionary. For OPV, Bharat products remain pre-qualified, as a risk-benefit assessment by the WHO took into account that the vaccine bulks are supplied by another prequalified manufacturer for formulation and filling by Bharat and that the vaccine is administered by the oral route. mAb trial: Biocon gets positive results Biocon announced positive results from its double blind, placebo-controlled, phase III, TREAT-PLAQ study with Itolizumab in chronic plaque psoriasis. Itolizumab, the first humanized anti CD-6 monoclonal antibody, successfully met the pre-specified primary endpoint of significant improvement in Psoriasis Area and Severity Index (PASI-75) score after 12 weeks of treatment in patients with moderate to severe psoriasis compared to placebo. It also met multiple secondary endpoints after 12 and 28 weeks of treatment. This 52-week study conducted in India had a 12-week placebo controlled phase, 16-week consolidation and 24-week randomized withdrawal phase. It enrolled over 200 patients across placebo and two active treatment regimens. Stemade to expand services in Asia Stemade, a pioneer player in dental stem cell banking, is looking to offer its services in other countries in the Asia Pacific region, including Australia and Singapore. The technology for extracting pluripotent mesenchymal stem cells was sourced from the Institute Clinident Biopharma, a French company. It allows people to store their stem cells obtained from their extracted teeth, which would have been discarded otherwise. With over 100 collection centers across India and one opened in Chandigrah recently, Stemade hopes to offer the technology to the masses. This patent has been licensed for the Middle East and Asia Pacific. Plan to increase thyroid awareness Abbott and the Indian Thyroid Society have announced a commitment to improve thyroid disease awareness in women in India with the 'Make a Difference to Life - Think Thyroid, Think Life' program. Actor Ms Juhi Chawla has been named ambassador for this awareness initiative. The initiative is a first-of-its-kind in India. Since 2010, 10 lakh individuals have been screened at the diagnostic and education camps held in India through the program. In 2012, the effort will expand to reach out to more than 10 lakh women. It is estimated that approximately 40 million Indians suffer from thyroid related disorders, of which 60 percent are women. India to launch supplement program The Ministry of Health and Family Welfare, Government of India, will soon launch a weekly iron and folic supplementation program. The program, implemented across the country in both rural and urban areas will cover nearly 12 crore adolescents. The ministry has suggested to the states that a fixed day in a week be earmarked for providing tablets to adolescents. Out of the 12.2 crore adolescents in India (according to census 2011 projected population) in the age group of 15 to 19 years, approximately 5.7 crore are girls, of which 3.2 crore are anaemic. To address this, the states have been advised to project their fund requirements. AXP gets ministry's nod in India India's Ministry of Health has approved the AutoXpress System (AXP), a product of Thermogenesis, used for the processing of stem cells from cord blood, enabling the company to initiate commercial sales of the product in India. Mr J Melville Engle, chairman and chief executive officer of ThermoGenesis, noted that the AXP approval in India comes even as the company awaits approval of the product in China. He said they were hopeful of getting regulatory approval in China in early 2012. Plan for complete immunization Declaring 2012 as the year of intensification of routine immunization, India has stepped up its efforts to achieve complete immunization. Under this initiative, the government has also expanded the Universal Immunization Programme by introducing second dose of measles, hepatitis B and pentavalent vaccination. With the present full immunization coverage of children being 61 percent, the target is to vaccinate more than 12 crore children through supplementary immunization activity in 14 states. A web-enabled name-based tracking system has been put in place with a database of more than 10 million children. Parents are being sent SMS alerts before the due date of vaccination and health workers are also receiving the list of children due for vaccination through SMS. NRHM reports released Union Minster of Health and Family Welfare Mr Ghulam Nabi Azad released reports of the 5th Common Review Mission and the 8th Joint Review Mission of the National Rural Health Mission (NRHM) at a workshop in New Delhi. He congratulated the NRHM team of the Centre and the states for the hard work that has led to notable improvement in the health indicators of the country. He said achievements of the NRHM have been endorsed by independent surveys. As per the latest Sample Registration Survey (SRS), country's infant mortality rate (IMR) has reduced to 47 (SRS 2010) from 58 in 2005 and maternal mortality rate declined from 254 during 2004-06 to 212 in 2007-09. In high focus states such as Orissa, Rajasthan and Bihar, the IMR has dropped by 13 or more points since 2005. Fall in rural IMR has been consistently more than urban IMR for last three years. Assam, Uttar Pradesh, Uttarakhand and Rajasthan have recorded the largest fall in maternal mortality ratio of 90, 81, 81 and 70 points respectively. He asserted that Janani Shishu Suraksha Karyakram will provide free services to pregnant mothers and children and further reduce out-of-pocket expenditure by improving institutional delivery. He also said provision of essential drugs free-of-cost, standard treatment guidelines and basic minimum set of diagnostics at all the facilities is being planned in the 12th Plan to reduce financial stress on the poor patients. Merck Millipore to install water purifier in schools Merck Millipore, the life science division of Merck KGaA of Darmstadt, Germany, has selected two educational institutes in North India who will receive their new water purification system Aquelix. Jawahar Navodaya Vidyalaya, Ahmadpur, Uttar Pradesh and Government Medical College, Srinagar, were picked through a lucky draw during celebrations to mark the International Year of Chemistry 2011. Six more such systems will be distributed to schools and colleges in Ahmedabad, Mumbai, Bangalore, Hyderabad, Kolkata and Chennai over the next three months. Merck Millipore's Lab Water division, which provides water solutions for laboratory applications, is part of the campaign commemorating IYC 2011. Waters, Tecan sign agreement for assay platform Waters and Tecan Group have entered into an agreement to combine Tecan's Freedom EVO liquid handling platform with Waters ACQUITY TQD liquid chromatograph-mass spectrometer to automate sample preparation. Waters will combine the technologies from both companies into a single, fully-supported analytical system solution. The technology will help laboratories increase assay throughput and efficiency, improve profitability, and drive down overall assay costs. The firms announced the agreement at the annual Mass Spectrometry: Applications for the Clinical Laboratory meeting. Tecan is a leading global provider of laboratory instruments and solutions in biopharmaceuticals, forensics and clinical diagnostics. Ind-Swift to promote Roche test in India Roche Diagnostics entered into an agreement with Ind-Swift to promote its test for detecting heart attack, TROP T rapid assay, in India. Roche Diagnostics' TROP T rapid assay is a point-of-care test that can detect whether a patient is having a heart attack through a simple whole blood test. Troponin â€“T is used to measure damage to the heart muscle and to differentiate between non-cardiac chest pain and heart attacks. The TROP T rapid assay gives a reliable qualitative result within 15 minutes. Ind-Swift will promote TROP T among cardiologists, diabectologists, consulting physicians and general practitioners all over the country with its 225-people strong field force. â€œThis will give ISL a big chance to develop a strong presence in the cardiac field,â€? said Dr Gopal Munjal, MD & CEO, Ind-Swift Group. TAKE announces global release of PharmaReady 5.0 TAKE Solutions, a life sciences and supply chain management company, announced the availability of PharmaReady 5.0, a web-based regulatory compliance solution suite for life sciences organizations to ensure faster approvals for their new products. The latest version introduces new document management features, and delivers technology framework upgrades to enhance scalability, response time, and ease-of-use. PharmaReady 5.0 supports submissions to Swissmedic in addition to US FDA, Heath Canada and EMEA. It comes with an improved dashboard for easier navigation and management of documents from a centralized location, provides more visibility and control e-document or e-submission processes, and introduces new functionalities, including drag and drop for quicker document uploads. PharmaReady 5.0 includes an enhanced, highly scalable technology framework. ]]> <![CDATA['It could take many years to fully understand India market']]> https://biospectrumindia.com/news/95/3625/it-could-take-many-years-to-fully-understand-india-market.html https://biospectrumindia.com/news/95/3625/it-could-take-many-years-to-fully-understand-india-market.html Mon, 13 Feb 2012 15:08:00 +0530 Mr Adie Cleaver managing director, Cleaver Scientific Interview U K-based Cleaver Scientific is an ISO 9001:2000 approved company that specializes in manufacturing and distributing electrophoresis products for the life sciences and molecular biology markets. In India, the company's products are marketed through distributor company Future Bio-science. BioSpectrum spoke to Mr Adie Cleaver, managing director, Cleaver Scientific, at the India Lab Expo held in New Delhi recently. Mr Cleaver speaks about his views on the India market, the company's operations and products and expected growth. Q How important is the biotech market in India to you? India is rapidly emerging as a key global player in the biotech market. The potential growth over the next few years means that I will be ensuring that my company is in a strong position to have a large presence in India. Markets such as Europe are still growing but not at the rate or potential rate that the market in India offers. India is a big country and it could take many years to fully understand the market. Therefore, for a market so large and diverse as India, it is really important to find a partner who not only understands your requirements and aspirations as a supplier but also helps you to keep improving your products. Q How do you operate and what kind of distribution network do you have in India? Owing to the size and business potential of the market in India, it was vitally important to find a business partner to work closely with. Hence, we decided to find and work with a partner who understands which market segments are best suited for our products and be our exclusive distributor. After spending over two years, meeting and talking to various dealers and distributors, New Delhi-based Future Bio-science was made the exclusive distributor in 2005, and since then we have not looked back. As they have a great network and know the India market and customer base very well, they have increased their sales year-on-year at an extraordinary rate. The technical sales staff of Cleaver Scientific provides support to their sales and marketing persons in finding and expanding the customer base. Q What major products do you offer currently in the India market? Primarily, the products are vertical and horizontal gel electrophoresis equipment used to separate proteins and DNA for use in markets such as research, diagnostics and biopharmaceuticals. We also offer accessories you would associate with gel electrophoresis, such as power supplies, pipettes, general laboratory products and other consumables such as agarose. Q What is the USP of these products that makes them different from other competitive products? In the horizontal gel electrophoresis range of products, the tanks are seamless, light-weight and of durable construction and chemical resistance because of injection moulded from new-age NAS Plastic. The fast-fix cassette-style electrodes allow user to replace platinum electrodes in less than one minute. The products are compatible with modern low-to-medium voltage power supplies. The vertical gel electrophoresis has a long life, durable high specification components and inexpensive replacement parts. The good part is that the rapid set-up involves four simple steps and no transfer of glass plates between casting and running modules. A maximum of four gels may be cast simultaneously Also, the even pressure distribution across the frame prevents the glass plates from cracking, as well as ensuring even sample migration through the gel. It also accepts all types of 10x8 cm and 10x10 cm (WxL) precast gels, including SERVA, IDGel, Novex, Cambrex, Gradipore and Biorad. Q What was the revenue of the company in the last financial year? What kind of growth is expected in the current fiscal? Every year, we are growing in India at the rate of 30-to-40 percent and this year also the expected growth rate is 30-to-35 percent. Rahul Koul in New Delhi ]]> <![CDATA['We are a complete solution provider']]> https://biospectrumindia.com/news/95/2849/we-are-a-complete-solution-provider.html https://biospectrumindia.com/news/95/2849/we-are-a-complete-solution-provider.html Mon, 13 Feb 2012 15:07:00 +0530 Mr Deepak Parab CEO, Metrohm India Interview A key player in providing solutions in analytical chemistry, Metrohm has been catering to the electrochemistry and ion analysis needs of various industries in India, including pharma and biotech, through its subsidiary Metrohm India. Metrohm started its operations in India in June 1997 as a joint venture with Micro Devices. In June 2008, Metrohm India was launched as a 100 percent subsidiary of Metrohm AG, Switzerland. Headquartered in Chennai with over eight branches in the country, Metrohm India, in addition to supplying different instruments for titration and chromatography has also collaborated with other companies to supply instruments for spectrophotometery (from Analytik Jena AG) and colorimetery (from Applikon Analytical B V) for the life sciences industry. Mr Deepak Parab, CEO, Metrohm India, talks about the company's recent collaborations with Sigma Aldrich and factors leading to their success. Q Tell us about your collaboration with Sigma Aldrich? How will this collaboration benefit your customers? The collaboration with Sigma Aldrich is between Metrohm AG Switzerland and Sigma Aldrich Europe. According to this agreement, all Metrohm customers who procure Metrohm ion chromatography system will get 25 percent off on the list price of all chemicals and standards required for operations of Metrohm instruments. In India, Metrohm and Sigma decided to take this initiative further by not only giving 25 percent off on all chemicals required for operations of Metrohm IC but also all the chemicals and standards required for Metrohm titrators. In short, whenever anyone procures Metrohm instruments, or if they are Metrohm users, Sigma will extend 25 percent discount on all chemicals. Further, Sigma has taken another initiative wherein they will give a starting kit for Metrohm KF Titrator free at the time of installation. The idea behind various collaborations are basically to bring down the cost of ownership of the instruments. At Metrohm, we work with one goal that the instruments should not only be affordable, but also simple and easy-to-operate with minimum cost of ownership. After extending three years warranty to drive down the cost of ownership of Metrohm instruments, this is another initiative to bring the cost down. We are also looking for an association with Sigma Aldrich India to use its distribution channel to strengthen the bond with the company. Q What are the key features of your business model in India? One of the key features of Metrohm India is that we try to be a complete solution provider instead of just selling the instruments. We offer quality after-sales support in terms of installation, warranty service, preventive and routine maintenance and application support. The application laboratory serves the customer free-of-cost in terms of application support and also develops and analyses samples for free. We have more personnel in customer support, application laboratory and service support than in sales. Every branch office has a resident chemist assigned as customer support for problems concerning chemistry and applications. We also try to keep costs of instruments and costs of ownership low and be close to customer location. It is evident from several branches and resident offices and all activities in terms of customer support are monitored through a web-based server. Q How much time gap is there between introducing a product in the US or Europe and in India? I think India is one of the big and growing markets and all manufacturers are introducing their products elsewhere in the world and in India simultaneously. Metrohm as a policy always introduces products simultaneously in the world and in the India market. Metrohm always looks for products that complement our product range for distributorship. We are basically catering to a segment of ion analysis, electrochemistry, particle characterisation, spectroscopy and process analysers. Q What are the strengths of Metrohm in India? Metrohm India is known for quality after-sales support and this is our strength. We get a lot of repeat orders from customers who have patronised Metrohm for over a couple of decades. Probably, Metrohm India is one of the few organizations where the service and support team is larger than the sales force. Q What is your vision for the next two years for Metrohm in India? In the next two years, we would like to explore new areas of applications where we can establish Metrohm India as a preferred supplier. We plan to do major investments in the area of application laboratory and customer training center. All our activities will be customer-centric, and we will like to ensure that all our customers are satisfied. Q Can you tell us about special initiatives such as the biofuel brochure? When the biofuel industry was in its nascent stage in India, we came out with the biofuel brochure to showcase applications using Metrohm instruments for the biofuel industry in the areas of in-process, quality control and finished product analysis. Since we had a range of instruments for complete biofuel analysis, it was easy for customers to have a one-stop solution from one vendor. Manasi Vaidya in Bangalore ]]> <![CDATA['We pride ourselves on evolving constantly']]> https://biospectrumindia.com/news/95/1492/we-pride-ourselves-on-evolving-constantly.html https://biospectrumindia.com/news/95/1492/we-pride-ourselves-on-evolving-constantly.html Mon, 13 Feb 2012 15:06:00 +0530 Mr Jignesh Bhate, CEO, Molecular Connections Molecular Connections started in 2001 as a joint venture between Mr G V Prasad and Mr Satish Reddy, senior promoters of Dr Reddy's Labs, and Singapore government represented by Dr Limsoon Wong. It has now carved a niche for itself in the bioinformatics space in India with revenues in excess of $10 million. Termed as one of the fastest growing companies in India, growing at a compound annual growth rate of almost 100 percent in the last three years, Molecular Connections has expanded its services to build comprehensive databases, developing data mining tools for companies such as Merck, BD, AstraZeneca, Bayer Healthcare and GSK. The company has developed its flagship product, NetPro, which is a protein-protein database having almost 400,000 protein interactions. This database, available publicly and accessed easily, has a recall value of 99 percent. Its precision in identifying the protein in literature would be around 95 percent. Recently, the company entered into a collaboration with Elseiver, the largest provider of scientific, technological and medical (STM) literature in the world comprising over 25 percent of STM content. At the helm of operations at Molecular Connections is Mr Jignesh Bhate, CEO. In an interview with BioSpectrum, he speaks about the company's success and how the rapidly evolving pharma industry holds the key to its future progress. QWhat would you attribute your amazing growth rate to?  Mr Bhate:  I would say mainly three things. Firstly, the people. We are currently more than 750 people, of which about 650 are scientists with significant experience in both wet and dry labs. We have a team that is constantly coming up with solutions for the drug discovery chain. For example, systems biology was initially not a part of our plan, but our team recognized the need for it in the market and now we are very active in this area. Also, innovation plays a very key role. Earlier, we focused only on databases, but now we do text mining, curation and much more. The market is also constantly evolving. For example, now we see a lot of demand for informatics in clinical studies and plan to launch two services in this area by next year. We pride ourselves on constantly evolving our services and product offerings. Also, with the pharma companies eager to look for cheaper solutions because of major changes taking place in terms of patent expiry and generics competition, I believe we are at the right place at the right time. QHow would you describe your company in terms of size and operations?  Mr Bhate:  I would describe ourselves as a mid-sized company. We had started out by wanting to focus only on data mining, but have since then grown and diversified a lot. Earlier, we wanted to focus more on products than services, but now 70 percent of our revenue is from services. Our goal is to help design products for clients in all the stages of drug development pipeline, including target identification that requires a lot of text mining and also target validation. All of it is based on publicly available data that we have mined. In terms of text mining, we are the largest in the world. We have two facilities in Bangalore and Chennai and we hope to increase our strength to 2000 people by 2015. We have projected a growth rate of around 25-to-30 percent every year for the next three years, which means we hope to double our profits in that time. We are a cash conservative company, but a profitable one. In the last three years, we grew at a CAGR of almost 100 percent in terms of sales and 50 percent in terms of profits. QWhat is your view on the current scenario in the industry?  Mr Bhate:  Singapore always had good technology in government labs for bioinformatics and the people from Dr Reddy's Labs had immense experience in drug discovery pipeline, so it was a perfect match with all players, including me, having equity in Molecular Connections. Convincing pharma companies that we could do good work in text mining in India when no one had heard much about it was tough initially. Our business model did not evolve overnight. We acquired business stability after three-to-four years of operation. In 2001 when we started, there was a lot of hype and a lot of promise associated with bioinformatics. We have come full circle now. The year 2008 was bad for everyone, but we made it. In 2012, I think there will be consolidation in the industry. Companies that have developed core competencies in niche areas will survive. Also, the size of the industries will get bigger and smaller guys may get acquired. Now that the initial hype has died down, customers are coming back in moderate numbers. They have realized that even though the promise of bioinformatics is not false. QWith big pharma looking to spend less on R&D budgets, how will it effect a mid-sized company like yours?  Mr Bhate:  My overall sense is that in the long run it will have a positive effect. Pharma companies don't have much choice in terms of skill set, time and awareness about intellectual property issues, and India is much better than China. From a global perspective, India is a favored destination as cost-effectiveness is an undeniable advantage. There is a risk that these companies (MNCs) may decide to have their own subsidiaries for operations. In this case, the companies that have developed core competencies in their fields will survive, but those involved in more generic work may find it tough to compete with the MNCs. Even though our expertise is niche, we are constantly evolving and innovating in it. As long as we keep innovating and retaining our talent, we hope to continue growing profitably. QWhat does the future outlook look like for Molecular Connections?  Mr Bhate:  We may launch a database on adverse events from the systems biology perspective, which will provide all the known adverse effects of drugs. Currently, there isn't any comprehensive database for the same, and it could be very useful for drug companies looking to put drug candidates on clinical trials. We will be a 1000-people strong company this year. Also, we are developing an Indian patent database. We also plan to launch disease-specific databases using our existing content. To facilitate these plans, we are looking to expand to another facility in Bangalore. We have been looking for an acquisition this year, with which our growth rate will hopefully increase even more. After that, we might go for another round of funding. Manasi Vaidya in Bangalore ]]> <![CDATA['We're taking measures to ensure compliance']]> https://biospectrumindia.com/news/95/2700/were-taking-measures-to-ensure-compliance.html https://biospectrumindia.com/news/95/2700/were-taking-measures-to-ensure-compliance.html Mon, 13 Feb 2012 15:03:00 +0530 Dr Rajesh Jain, JMD, Panacea Biotec Panacea Biotec, set up as Panacea Drugs in 1984, was listed as a public company in 1995. Ranked India's third largest biotechnology company in the BioSpectrum-ABLE annual survey, the company has made significant progress in the recent years in terms of expanding its horizons and new product launches. Also, one of the company's product, PacliALL, won Product of the Year at the BioSpectrum Awards 2011. Dr Rajesh Jain, joint managing director, Panacea Biotec, talks about major milestones achieved by the company, the vaccine industry in India and future strategy of the company among others things. QWhat were the turning points for Panacea Biotec that paved the way for it to become a successful vaccine company?  Dr Jain:  In 1983, my elder brother Mr Ravinder Jain articulated a strategy that it was time to tap opportunities in biologics. He realized that a lot of children were affected by polio and it made him decide that the company should think differently rather than follow others' footsteps. From there, came a commitment to make novel and innovative medicines affordable to the masses and a dream of healthy India. We initiated a collaboration with an Italian company for manufacturing and marketing oral vaccines and I am happy that we have been a part of the polio eradication program. Without differential thinking and technological back-up, it would have been difficult to survive in an industry as competitive as the vaccine industry. This need gave rise to the first R&D center in New Delhi and a larger novel drug delivery systems (NDDS) facility in 1995 at Lalru, Punjab. In the same year, the company decided to go public and 18 crore was raised through initial public offering. The company entered into several collaborations and put in place all the facilities. Since then, there has been no looking back. QWill Panacea Biotec continue to see the kind of growth (32 percent) recorded last fiscal? What is your future outlook?  Dr Jain:  So far, we have shown consistent growth but due to certain setbacks, we unfortunately could not grow in this financial year. There have been certain disruptions, but I am confident that we will bounce back in 2013. Our performance has been affected by the delisting of pentavalent vaccine from the WHO's list of prequalified vaccines, following a routine site audit by a WHO team in July 2011.We have initiated corrective and preventive measures to ensure compliance with the WHO pre-qualification guidelines and are in touch with WHO in this respect. We are confident that with these corrective and preventive measures, we will be able to get re-listing of our pentavalent vaccine in the list of WHO prequalified vaccines. Our products such as Easy Five and HPV Vaccine are the growth drivers. Also, we are expecting 50 percent increase in the business of branded generics in emerging markets. Our focus is on branded generics, biosimilars and vaccines. We are working on new chemical entities in central nervous system, diabetes, and anti-infectives. Also, we are looking for new biological entities in diabetes and rheumatoid arthritis. Presently, our hands are full but with continuous churning within the company, we may start innovating in other areas as well. Now, we have also ventured into healthcare delivery. We are about to launch a new multi-specialty hospital with 200 beds in Gurgaon, Haryana. Our major focus areas will be organ transplant, cancer, hip replacement and cardiology. QWhat is the idea behind Panacea's Vision for 2020 and the 'Think India, Think Medicine' campaign?  Dr Jain:  Somewhere around 2007, when we were having brainstorming sessions on our future line of action, we had a vision to be the largest biotech company by 2020. The vision is built in our core areas of customer, finance, innovation, people and internal process. The foundation was laid by asking 800 executives of the company about the key result areas for realizing this vision. 'Think, do and deliver' became our long-term human resource policy. We made data more accessible to everyone, available with the click of the mouse. The values are not imbibed once the company has been built, but is incorporated during the early stages. We, at Panacea, had the core motto as integrity, humanity and innovation. The missing thing was country. While it is important to build a company, it is equally important to build a nation. That is the idea behind 'Think India, Think Medicine' campaign. QHow has the progress been for the vaccine industry in India?  Dr Jain:  The vaccine industry in India is in a very good situation today, thanks to work done by Serum Institute of India, Pune, that has established us globally. Well-known international agencies, such as the World Health Organization and the United Nations Children's Fund, have utilized services from India. During the last five years, the Global Alliance for Vaccines and Immunization and the Bill & Melinda Gates Foundation have done great work in India. All these have put the vaccine industry in India on top as our mission has been to bring out good, affordable and quality vaccines. This industry has set an example where all the companies are coming together to protect 100 million children from developing countries against diseases. My belief is that it would be a shame if people died of diseases even in this modern age. I believe that the vaccine industry in India has learnt to work collaboratively with all stakeholders. It has overcome the challenge of producing new vaccines in large capacity and built a strong value chain management over the period of time. I think with all these ingredients, we are set to continue to grow and contribute globally. This is very satisfying. QWhat kind of growth has the biotech industry registered so far?  Dr Jain:  Like any other industry in India, biotechnology too has done well. Government agencies in the last two-to-three years have tried to help budding entrepreneurs through various schemes. I really appreciate the good work done by the Department of Biotechnology, especially through the Small Business Innovation Research Initiative and the Biotechnology Industry Partnership Programme schemes. Many small companies that have been established in recent years are also doing well. I am sure we will be able to see the results in the next 10 years, when they start maturing. It is a very good beginning and it is really great to see the way the industry is coming along. QWhat is your take on the regulatory hiccups?  Dr Jain:  There certainly are issues in terms of speed and a lot requires to be done in order to minimize the time lines for approvals. However, criticizing doesn't always help. If one thinks about a nation, competition and clients alike, there is nothing that can stop growth. One stops growing when one stops looking at competition objectively and is not able to see the value created by it. We don't believe in criticizing the government because it doesn't actually help. We are all part of the same process and I believe that we must have frequent interactions to resolve issues. Rahul Koul in NewDelhi ]]> <![CDATA['We aim to provide integrated biosolutions']]> https://biospectrumindia.com/news/95/2122/we-aim-to-provide-integrated-biosolutions.html https://biospectrumindia.com/news/95/2122/we-aim-to-provide-integrated-biosolutions.html Mon, 13 Feb 2012 15:01:00 +0530 Mr Peter Bains non-executive chairman, Fermenta Biotech Fermenta Biotech (FBL) has had many laurels to its credit since it was incorporated as a 100 percent subsidiary of DIL group of companies in 1986. It is a pioneer of Penicillin G Amidase enzyme in India and has emerged as a leader in enzyme technologies for betalactams. It also makes cost-effective and efficient enzymes for application in betalactam production. Fermenta is a premier vitamin D supplier and vitamin D3 manufacturer, a business it took over in 2004 from DIL that was manufacturing vitamin D3 since 1974. The company made news in 2011 when Evolvence India invested 40 crore in the company. Mr Peter Bains, the non-executive chairman of Fermenta Biotech, throws light on the company's game plan for India and the significant investments in its facilities. Also a board member of Syngene International, Mr Bains shares his optimism regarding the biotech enzyme market in India in the coming months. QTell us about the milestones FBL has reached in biotech sector and other divisions over the past one year?  Mr Bains:  Fermenta Biotech has been making good progress across all its business platforms. In its biotech division, the company has been developing a novel, patented and eco-friendly enzymatic technology for the production of antibiotics such as Amoxicillin. This process has been successfully scaled up and the new enzyme, Fermase, is now commercially available. In addition, Fermenta has invested in research on novel enzymes that can play a role in environment-friendly manufacturing processes. In its vitamin D3 division, strong sales and positive outlook have helped the company complete the construction and commissioning of a state-of-the-art manufacturing facility in Dahej, Gujarat, which will provide capacity for future growth and allow product development. In its environment division, the company has tied up with two leading European companies to provide sustainable bio-solutions to address a range of environmental pollution challenges related to waste water management, oil remediation, lake remediation and sewage treatment. We are now beginning to pilot some of these products and services in India. In its specialty API division, record sales for vitamin D3 product group were achieved. Sales were generated from 38 countries as against 30 last year. Feed grade formulation was introduced in the European and American markets and was well received. QCan you elaborate on the developments at FBL in terms of infrastructure and manpower?  Mr Bains:  Over the years, the company has invested over 25 crore in infrastructure, which includes modern manufacturing facilities and a well-equipped modern biotech R&D facility. The company has also accelerated its investment in R&D to bring in various pipeline products. It has a team of over 45 people for its biotech business. Fermenta is planning to set up a new fermentation facility in the special economic zone of Dahej in Gujarat. At the R&D level, the company is planning to invest on new equipment and new talent enabling the development of new technology platforms. QHow do you see the biotech enzyme market in India in the next one year?  Mr Bains:  The worldwide demand for enzymes is expected to touch $4.4 billion by 2015 (at a compounded annual growth rate of six percent). Based on information from the Ministry of External Affairs, Government of India, the bioindustrial (enzyme) market in India clocked $142.3 million in 2010-11, growing at a rate of 10.9 percent, as against $128.2 million in 2009-10. Based on the global trend and the prevailing Indian scenario, we expect a good growth. QWhat is the business strategy of FBL in India ?  Mr Bains:  Fermenta Biotech aims to be among the leading specialized global technology providers in biospace by focusing on innovative, proprietary and eco-friendly technologies. In pharmaceutical and fine chemical industry, the focus is to replace the prevalent hazardous chemical manufacturing practices into eco-friendly and green processes. In environmental bio-solutions space, the focus is on sustainable bio-solutions for environmental problems. QTell us about the biotech product line of the company?  Mr Bains:  Our main products are Fermase PS 150, a novel enzyme product for enzymatic Amoxicillin, and Fermase PA 850, an improved enzyme for beta lactam and cephalosporin intermediates. Both versions of these products have been pilot-tested and we have initiated the commercial sales. In pharmaceutical and fine chemical space, the company aims to provide integrated bio-solutions. For example, the company is working on proprietary enzyme for cephalosporin synthesis as well as enzyme for fine chemicals. In environmental sector, the company is working on new technology platforms for efficient bio-remediation of waste. QWhat have been the challenges faced by the company in the biotech space in India?  Mr Bains:  For any technology, there is an initial barrier of acceptance, especially when the new technology is focused on replacing age-old and well-established practices. However, with the consistent efforts and technological supremacy, Fermenta has been able to make progress. Nayantara Som in Mumbai ]]> <![CDATA[Polio in exit mode: Is the battle over yet?]]> https://biospectrumindia.com/news/95/2010/polio-in-exit-mode-is-the-battle-over-yet.html https://biospectrumindia.com/news/95/2010/polio-in-exit-mode-is-the-battle-over-yet.html Mon, 13 Feb 2012 15:00:00 +0530 India has not reported a single case of polio in the last 12 months. However, given the live nature of polio viruses and their continued existence in the environment, experts say complete eradication could still be a challenge India recently received a pat on the back from the World Health Organization (WHO) after it was reported that there have been no new cases of polio for a year in the country. The news meant freedom from a disease that about five decades ago was among the most feared diseases known for crippling children. WHO also said India's success could mean the list of polio endemic countries could soon be reduced to three â€“ Pakistan, Afghanistan, and Nigeria. Dr Hamid Jafri, project head, National Polio Surveillance Project (NPSP), says, â€œGiven the size and scope of the challenge and the epidemiologic challenges and innovations that the program in India has done, if India succeeds in eradication of polio, the whole world succeeds.â€? The NPSP was launched in 1997 jointly by the Ministry of Health and WHO. Data from the NPSP shows that between January 13, 2011, and January 12, 2012, no new cases of polio have been reported in India. However, at the same time, around 1,230 fresh cases of acute flaccid paralysis (AFP), mostly from Uttar Pradesh and Bihar, were reported till January 21, 2012. This has also set the tone for a debate on whether this success in the battle against polio is going to last long. The fear is generated from the fact that there is always a risk that vaccines containing live viruses may reintroduce the disease in places that are becoming polio-free. Another cause of worry is that there is a threat that the disease may find its way back from across the border (Afghanistan and Pakistan). The Indian government will have to maintain strict vigilance and respond rapidly to guard itself against import of any circulating polio virus. Role of vaccine companies The government spends close to 1,290 crore annually on the polio eradication program, which has now been integrated with the National Rural Health Mission. According to rough estimates, around 50 percent of this allocation goes into buying vaccines. Praising the contribution of the bivalent vaccine, Health Minister Mr Ghulam Nabi Azad recently said, â€œThe real scenario changed after the introduction of a bivalent oral polio vaccine in January 2010. The new polio cases have come down significantly from 741 in 2009 to 42 in 2010 and only one polio case during 2011.â€? Since type 2 has already been eliminated, a three-strain oral vaccine called tOPV is being phased out in favour of a bivalent or two-strain vaccine called bOPV, which fights type 1 and type 3 virus. Dr Rajesh Jain, joint managing director, Panacea Biotec, says, â€œWe are the only company meeting the demand for bivalent oral polio vaccines in the country at present. To keep the virus at bay, we must keep innovating.â€? Panacea Biotec, which has been a major supplier of vaccines to National immunization Programme (NIP), supplied more than six billion doses of WHO-pre-qualified polio vaccine to the Government of India and the UNICEF. As a sequel to the completion of full range of oral polio vaccines (tOPV, mOPV1, mOPV3 and bOPV), Panacea Biotec introduced the next generation inactivated polio vaccine (eIPV) through a collaboration with The Netherlands Vaccine Institute. The sale of polio vaccines has been a major contributor to the vaccine business revenue of Panacea Biotec, which is 70 percent of its total revenue. Until the 1980s, vaccine requirements in India were met mainly through public sector vaccine institutions. The Pasteur Institute of India in Coonoor, Tamil Nadu, produced polio vaccine between 1967 and 1977 with the help of seed virus from Dr A B Sabin, who developed OPV with the approval of the WHO. The Haffkine Institute was able to produce OPV, but this was discontinued for reasons not clear. In 1987, the Department of Biotechnology established a new public sector unit, Bharat Immunologicals and Biologicals Corporation (BIBCOL) at Bulandshar, Uttar Pradesh, with technology transferred from the Institute of Poliomyelitis and Viral Encephalitis in Moscow, Russia. The company started formulating OPV in bulk since January 1996 and in 1999, the company acquired WHO-GMP certification and supplied about 1,016 million doses of OPV to the NIP so far. â€œWe are very proud of the fact that we have a series of firsts to our credit. We are the first Indian company to provide oral polio vaccine in the country since 1990,â€? says Mr Sreeshan Raghavan, managing director, BIBCOL. Another company Bio-Med started its human vaccine division with oral polio vaccine in 1995. The company's vaccine is included in the Pulse Polio program conducted by the Ministry of Health and Family Welfare under Extended Program of Immunization (EPI). The threat in oral vaccine Calling OPV a savior, Mr Hamid Jafari says, â€œIt is the OPV that is even now preventing tens of thousands of children in India from getting polio every year. It is important to appreciate the huge number of cases this vaccine is averting.â€? The irony is the side effect of the OPV. Live viruses will be administered through OPV to people and the environment. Therefore, the resurgence or importation of wild polio virus remains a threat to the children in India. According to the NPSP, the vaccine-derived polio viruses (VDPVs) are strains of polio viruses that emerge after prolonged multiplication of attenuated strains of the virus contained in the oral polio vaccine in the guts of children with immunodeficiency or in populations with very low immunity. After prolonged multiplication, these vaccine virus-derived strains change and revert to a form that can cause paralysis in humans. Some VDPVs have shown a capacity for sustained circulation in communities. India has identified seven cases of VDPV (six of type 2 and one of type 3) in 2011. Alternative to OPV Few argue that even though India always had an effective indigenous injectable polio vaccine, OPV was recommended in developing countries because international organizations were trying to find new markets for US multinational corporations. However, one cannot deny that we owe our success to oral polio vaccines as they are highly effective, cheap, and easy-to-deliver. â€œThe best way seems to be the use of oral polio vaccines to stop transmission and then switching to inactivated polio vaccines (IPV) after the virus has been contained. But it works better by producing protective antibodies in the blood, thus preventing spread of the polio virus to the central nervous system,â€? says an expert at the NPSP. The problem here is that unlike OPV, IPV is difficult to deliver because it has to be injected by trained health workers in clinics. Also available at 300 per dose, the vaccine is five times costlier than the currently used OPV. Currently, research teams are looking at ways to make IPV more accessible. One option being explored is the addition of an adjuvant, thereby lowering the amount of antigen needed in the vaccine. Another one might be developing a way of injecting the vaccine into the skin, rather than under it. It is a method that would require a lower and therefore cheaper IPV dose. Though there is no denying the fact that we have been able to contain polio successfully, we must remember that the virus is still there and continues to affect a certain section of population. Therefore, the big question that still remains is whether we can actually call it complete eradication. Rahul Koul in New Delhi ]]> <![CDATA[Opportunities amidst crisis]]> https://biospectrumindia.com/news/95/1768/opportunities-amidst-crisis.html https://biospectrumindia.com/news/95/1768/opportunities-amidst-crisis.html Mon, 13 Feb 2012 14:58:00 +0530 The overall debt crisis in the EU and the US is bringing a lot of business possibilities for Indian firms as they offer competitive advantages in terms of cost and quality The economic crisis in the European Union and slowdown in the US may not have affected the biotechnology industry in India, however, the recent trend of a weakening rupee against the dollar could impact foreign investments in the sector. The present situation appears to be more of a mixed bag of opportunities and challenges for the Indian biotechnology companies. Pharma exports have been hit in the recent months, but biotechnology has seen only marginal affects, and experts opine that in the coming months, its insulation from the crisis will be constant. The 20,000 crore ($4 billion) biotechnology industry in India, including the biopharma and the bioservices segments, constitute 80 percent of the industry's revenue with the highest exposure to exports, especially to markets in the US and EU. These include companies such as Biocon, Serum Institute of India, Panacea Biotec, Advanced Enzymes Technologies and Concord Biotech. India favorite Industry experts say that there is going to be only a marginal impact on these companies due to a rising demand for biopharmaceuticals and vaccines, and bullish sentiments of the global community about Indian biosimilars. â€œWe expect marginal impact in the short term. Other segments such as bioagri, bioindustrials and bioinformatics derive maximum revenue from the domestic market,â€? says Mr Anjan Sen, director, strategy and operations, Deloitte in India. Mr Ajit Mahadevan, partner, life sciences, Ernst & Young, says that there will be greater demand for biosimilars, and discovery and development-related services. â€œThis may be a good opportunity for Indian biotech companies as majority of them are engaged in vaccines or contract services and offer competitive advantages in terms of cost and quality. With the crisis taking a turn for the worse, many global companies might look at cutting down R&D costs and budgets,â€? he says. Mr Sujay Shetty, partner, pharma and life sciences, PricewaterhouseCoopers, has a similar opinion. â€œMany global companies might shelve their in-house R&D programs and instead outsource clinical trials to CROs that are based out of emerging countries such as India,â€? says Mr Shetty. It is also time for Indian biotech companies to look at emerging markets for businesses. Mr Sen says that this opportunity can help biotech companies focus on emerging markets and enable them to come up with innovative and sustainable business models. â€œAccording to a study, the BRIC nations (Brazil, Russia, India and China) will provide the bulk of incremental growth for the healthcare market in the coming decade. Reforms being undertaken by the governments in these markets will also help the sector grow substantially,â€? he points out. However, companies such as Lupin and Advanced Enzymes still maintain that the US and EU are their important markets and shifting complete focus from such markets is not on their cards. Dr Cyrus Karkaria, president, biotechnology, Lupin, says, â€œLupin has its presence in the emerging markets and we will always use that to our advantage for biologics too. However, markets such as the US and EU are equally important for us.â€? Experts also see it as an appropriate time for biotech companies to enter into marketing alliances and tie-ups. â€œSmaller biotech innovator companies can tie-up with organizations having strong marketing and sales muscle and try to reach to the masses in India itself. We expect tie-ups and partnerships to continue in the biotech space, although there may be fewer acquisitions,â€? adds Mr Sen. Fund crunch The negative side is that funding into the Indian biotech industry, especially from regions such as the US and EU, may take a beating. â€œThe larger Indian biopharma industry has limited reliance on investor capital, thus in terms of unavailability of funds the situation hasn't changed much. However, the smaller Indian biotech firms are facing issues similar to those faced by the global biotech companies. This includes the fact that 80 percent of the funding is going to 20 percent of the biotech companies (with Indian and many other biotech companies having to manage with the remaining 20 percent funds),â€? says Mr Mahadevan. This is coupled with the fact that most of the small biotech companies do not have a risk management strategy in place. Companies having business set-ups in Spain and Italy may also suffer setback. â€œCompanies that have significant exposure to markets, such as Spain and Italy, are likely to be on the front line of the impact as their governments have adopted a slew of measures to contain healthcare expenditures. Having said that, governments in other countries are expected to follow suit and hence players who are focusing on those markets would be impacted as much,â€? adds Mr Mahdevan. All for a weak rupee For biotech companies, it is more of a no-loss, no-gain situation. â€œA large proportion of the drugs exported by biotech companies, especially vaccines, are mainly to organizations such as the World Health Organization, wherein prices are already pre-decided and appropriate foreign exchange (forex) impact mitigation measures are in place. For pharma exporters, it is good news although manufacturers may see their input costs rising in the near future,â€? says Mr Vishal Gandhi, senior vice president and head, life sciences, YES Bank. According to Mr Mahadevan, the fluctuation is an opportunity amidst crisis. â€œCurrency fluctuations are characteristic of every recession and should be looked at in that light. The weakening trend may continue or reverse and companies should be cognizant of this. It is time when it is not only sufficient to have a competitive product or service, but also equally important to bargain favorable trade terms,â€? he says. â€œThe constraints are forcing companies to work and excel on multiple fronts, which may be a good sign from a long-term sustainability point-of-view,â€? he says. Mr CL Rathi, MD, Advanced Enzymes Technologies, sees a more long-term impact on the company's business. â€œWe have been focused on increasing our exports. Naturally, some export sales will not materialize quickly. We are now working to improve our services by employing an European subsidiary company,â€? he says. CROs in India are likely to be at an advantage. â€œIndian CROs will benefit from the weakening rupee as their contracts are mainly dollar-backed. Those on the development side of clinical trials will be positively impacted as most western life science companies will now increase outsourcing of their trials to CROs in the emerging countries,â€? adds Mr Gandhi. But the situation may make foreign investors reluctant to invest in the country. â€œSince the fluctuations affect the global banking system, we will see foreign investors taking a backseat and reluctant to invest into the country,â€? adds Mr Shetty. Agrees Mr Gandhi, â€œPE investments in this area will take a hit as a major chunk of the money is raised in the US and EU markets. It is important that companies have a risk management strategy in place to hedge themselves.â€? In this case too, the impact would be mostly felt by small companies, who do not have a risk-mitigation strategy against risks of forex fluctuations and are unable to hedge their export revenues. However, companies will also see a rise in the cost of raw materials and other logistics as-far-as exports are concerned. â€œDepending on the kind of markets you will be exporting to, there will be some kind of impact on exports because there is a lot of competition in the market,â€? says Dr Karkaria. In the near future, crisis will continue with cuts in healthcare budgets being the top priority for many countries. Pressures of pricing and reimbursement are also here to stay for some time. â€œThere can be largely two approaches to sustain: prove it or lose it. This means that you need to pursue therapeutic areas and strategies to demonstrate how you are improving outcomes, and thus do more with less,â€? concludes Mr Mahadevan. Nayantara Som in Mumbai ]]> <![CDATA[Vaccine research laps up Indo-US deals]]> https://biospectrumindia.com/news/95/1732/vaccine-research-laps-up-indo-us-deals.html https://biospectrumindia.com/news/95/1732/vaccine-research-laps-up-indo-us-deals.html Mon, 13 Feb 2012 14:56:00 +0530 Both India and the US are making collaborative efforts in life sciences. The vaccine sector has particularly benefited from the partnerships that have taken place between the two nations Over the past five years, a significant number of joint R&D projects have been inked between India and the US in the vaccine segment. One of the most recent such collaboration has been signed between Indian vaccine major, Serum Institute of India, and US vaccine giant Merck. The collaboration, which was inked in August 2011, will help develop and commercialize pneumococcal conjugate vaccine (PCV) for use in the emerging and developing world. While the governments have been proactive in forging long-term deals, such as joint R&D projects, human resource development, exchange of visits, joint workshops and academia-industry interaction, biotech companies from both countries have also made efforts at their level. Apart from Serum Institute of India, Biocon, Bharat Biotech and Shantha Biotechnics have entered into alliances and partnership with US companies or organizations in areas such as vaccines and biopharma. While India has received continued help from the US in various domains of science and technology, there are several advantages that India has to offer to the US. The factors that favor India include its large pool of skilled and cost competitive manpower, advanced chemical synthesis technologies, manufacturing practices conforming to the US and EU norms, and global recognition as a producer of low cost, high quality bulk drugs and formulations. Also, the well developed, integrated scientific infrastructure offers major benefits. Dr Rajesh Jain, joint managing director, Panacea Biotec and president, CII committee on Biotechnology, who was recently part of the India pavilion at US BIO, says, â€œDuring my interaction with the prominent people there, I must say that they gave tremendous response and respect to the Indian industry. They rate Indian science is at a high pedestal.â€? Past, present, future Indo-US collaborations in science and technology (S&T) go back to the 1950s when scientists from both countries inked joint R&D deals in areas of agricultural research. By 1960s and 1970s, there was an augmentation of S&T collaborations, when American scientists joined hands with premier institutes in India such as the Indian Institute of Technology (IIT) and the National Council of Education, Research and Training (NCERT), New Delhi. This subsequently led to the establishment of the Joint S&T Sub-Commission in 1974. A US-India Fund (USIF) was established in January 1987 with funding of 217 crore, which supported more than 50 workshops and 300 research projects in science and technology over a period of 11 years. Partnerships between the two countries have been an ongoing process. On October 17, 2005, an agreement was signed following which India's Prime Minister Dr Manmohan Singh and former US President Mr George Bush agreed to set up a bi-national S&T commission. This would build upon the bilateral agreement on science and technology signed in October 2005, and provide a framework for a vigorous public-private partnership. The commission would have an open architecture and encompass existing and ongoing bilateral programs that included DST-NSF program of co-operation, an Indo-US S&T forum, an Indo-US collaborative program in nano-technology and an Indo-US vaccine action program. Also, the present slowdown in the US economy has opened a world of opportunities for Indian companies, mostly in terms of collaborations and alliances. Companies in the West are cutting down R&D budgets and, hence, will look at emerging nations such as India to outsource their R&D projects. Speaking on the collaboration with Serum Institute, Ms Julie L Gerberding, president, Merck Vaccines, says, â€œExpanding vaccine access to emerging and developing markets is top priority and we feel strongly that this collaboration will be a giant step towards impacting the devastation of pneumococcal diseaseâ€?. Merck and Serum Institute will form a product advisory committee to oversee the activities required to develop and seek approval for PCV, and pursue the World Health Organization's (WHO) pre-qualification. Under the terms of the agreement, Merck, through an affiliate, will receive specific rights to market PCV in certain designated territories and Serum will receive specific rights in other territories. Both companies will contribute to the development and manufacture of PCV. Another vaccine major from India, Bharat Biotech, has entered into a public-private collaboration for development of its rotavirus vaccine, Rotavac, in collaboration with the Department of Biotechnology, Government of India; Bill and Melinda Gates Foundation; Programme for Appropriate Technologies in Health; Centers for Disease Control, US; National Institutes of Health, US; NIAID, US; Society for Applied Studies; Translational Health Sciences Technology Institute; the Indian Institute of Science, India; the All India Institute of Medical Sciences (AIIMS), India; and Stanford University, US. The vaccine is priced at around 50 ($1) and India licensure is expected in 2014, while WHO pre-qualification is expected in 2015 for supply to UN agencies. It is currently undergoing phase III clinical development for safety and efficacy in 10,000 subjects, one of the largest such clinical trial conducted in India. Major Indo-US collaborations MoU on November 7, 2002, between Biotechnology Industry Organization, Pharmaceutical Research and Manufacturers of America, the US-India Business Council, and the Confederation of Indian Industries to establish the US-India biotechnology alliance with an objective to promote cooperation between businesses in India and the US in the area of biotechnology. Co-operation in nanotechnology: In June 2005, an agreement was signed to establish a co-operative research program in the field of nano-technology between Rutgers University, the International Advanced Research Center (IARC) at Hyderabad, and the NEI Corporation, which is a Rutgers spin-off company in New Jersey. Indo-US science and technology (S&T) umbrella agreement on October 17, 2005, with special emphasis on sharing of intellectual property rights. Establishment of Indo-US bi-national S&T commission in 2006 for fostering R&D and scientific exchanges between universities and research institutions. Indo-US co-operation on emerging and re-emerging infectious diseases and disease surveillance to study TB, malaria, avian influenza, nipah virus and severe acute respiratory syndrome. US-India HIV/AIDS private sector corporate initiative: Following on India's recent scale up of resources and renewed political commitment to fight HIV/AIDS, the former US President, Mr George Bush, announced an additional US contribution of around 35 crore ($7 million) to expand resources available to fight HIV/AIDS in India. Indo-US vaccine action programme with priority areas, including viral hepatitis, typhoid, E. coli, rotaviral diarrhoea, acute respiratory infections, tuberculosis, leishmaniasis, malaria and HIV. (Courtesy Embassy of India, Washington DC) Bharat Biotech has also invested 200 crore to 250 crore in clinical trials. The Hyderabad-based company, which clocked an annual turnover of 298.34 crore in FY 2010-11 (BioSpectrum-ABLE Top 20 survey 2011) also has a collaboration for its malaria vaccines with the International Center for Genetic Engineering and Biotechnology (ICGEB), New Delhi; PATH, US; Global Alliance for Vaccine Initiative, US; and Malaria Vaccine Initiative, US. On similar lines, Shantha Biotechnics has had a collaborative deal with PATH and the US National Institute of Health (NIH) since 2007 for the development of a rotavirus vaccine. The technology in this case has been licensed from the NIH. Also, animal vaccine major Indian Immunologicals (IIL) has a spree of collaborations with institutes in the US, including those with the Harvard Medical School, US, for the development of polysaccharide vaccines and with Veterinary Technologies Corporation, US, for brucellosis vaccine. It also has a partnership with the Center for Disease Control (CDC), US, for hepatitis A and rabies. Philanthropic organizations such as the Bill and Melinda Gates Foundation have also been instrumental in forging joint research collaborative deals between the two countries in the recent years, especially in the area of vaccines. They urged the stakeholders to intensify progress on vaccinating the population, especially children. During their visit in March 2011, Dr Bill and Ms Melinda Gates announced grants to fund late-stage clinical trials to Pune-based Serum Institute of India and Hyderabad-based Bharat Biotech for pneumonia and rotavirus vaccines. The foundation is expected to grant around $30 million for late-stage clinical trials of rotavirus vaccines. In 2009, Syngene International, a subsidiary of Indian biotechnology major Biocon, and Bristol-Myers Squibb (BMS) opened a dedicated R&D facility for the latter at the Biocon Park in Bangalore. The 200,000 square-feet facility is dedicated to augmenting BMS's work in discovery and early drug development. Work at the facility spans drug discovery and development process from initial hit to lead optimization, early pharmaceutical development and clinical nomination to phase I and II clinical studies. Panacea Biotec also has an in-licensing arrangement with the National Institute of Health, US, for use of a peptide-based product for generation of hair follicles and hair growth. Another company, Transgene Biotek is co-developing cancer drugs based on siRNA with an US-based company. Industry bodies in proactive mode A number of associations are playing a significant role in attracting global attention to the Indian biotech industry. They include the Confederation of Indian Industries (CII), Federation of Indian Chambers of Commerce and Industry (FICCI), the Associated Chambers of Commerce and Industry of India (ASSOCHAM) and Association of Biotechnology Led Enterprises (ABLE). These associations have been organizing various events focused on promoting Indo-US collaborations in biotechnology. The bilateral Indo-US Science and Technology Forum (IUSSTF) has been working with government departments, such as the Department of Science and Technology, Department of Biotechnology and US Department of Energy, along with industry associations to effectively bring together government agencies, corporate houses and industry associations and the academia of both the countries. FICCI's Center for Technology Commercialization (CTC) has assisted more than 150 innovators to provide a platform to showcase their creativity on a local and global level and helped them generate revenue worth 350 crore (DST-Lockheed Martin India Innovation Growth Programme). The CTC also played an instrumental role in commercializing about 30 Defense Research and Development Organization (DRDO) technologies, and talks are on for about six more DRDO technologies. FICCI also signed a memorandum of understanding with the Maryland Department of Business and Economic Development. The CII sent its 10th Biotechnology Mission to BIO 2011, which was organized at Washington DC from June 27 -30, 2011. The 50 delegates visited prominent life sciences institutions, such as the NIH, Johns Hopkins University and the University of Maryland, where they got opportunity to interact with eminent scientists and leaders. The CII mission members also had interactions with budding entrepreneurs in a special program designed for one-to-one interactions called BioBiz. The CII also promoted the advancements of the Indian biotechnological panorama through the India pavilion at BIO 2011 in association with ABLE and facilitated by the DBT. â€œFICCI is playing a great role to promote Indo-US collaborations in the area of biotechnology because more than 80 percent of the merger and acquisition investments were seen in the five major sectors,â€? concludes Mr Arnab Kumar Hazra, director, biotechnology, FICCI. Nayantara Som in Mumbai (with Rahul Koul in New Delhi and Manasi Vaidya in Bangalore) ]]> <![CDATA[Mission: Rapid diagnostic detection of dengue]]> https://biospectrumindia.com/news/95/7212/mission-rapid-diagnostic-detection-of-dengue.html https://biospectrumindia.com/news/95/7212/mission-rapid-diagnostic-detection-of-dengue.html Mon, 13 Feb 2012 14:51:00 +0530 The transfer of a technology developed by ICGEB to J Mitra has resulted in the successful commercialization of a diagnostic product for early-stage detection of dengue Since there is no treatment currently available for dengue, the key is early detection, recognition and understanding of the clinical problems during the different phases of the disease. However, the tests available are mostly based on the detection of specific antibodies of the dengue virus. The limitation is that these antibodies are produced several days after the first clinical symptoms appear. New Delhi-based J Mitra, in collaboration with the International Center for Genetic Engineering and Biotechnology (ICGEB), New Delhi, introduced a rapid ELISA-based test for diagnosing the dengue virus. The specific detection of dengue virus using NS1 antigen can be done on the first day itself, thereby saving valuable time of the patient. Named as the Dengue Day 1 test, this rapid solid phase immuno-chromatographic test is for the qualitative detection of dengue NS1 antigen and differential detection of IgM and IgG antibodies to the dengue virus in human serum. This test is for in vitro diagnostic use only and is intended as an aid in the earlier diagnosis of dengue infection and presumptive diagnosis between primary and secondary dengue infections. The funding of upto 50 lakh from the Department of Biotechnology (DBT), Government of India, served as a major catalyst to the research efforts by Dr Navin Khanna Group Leader, Recombinant Gene Lab, ICGEB. The technology developed by him was transferred to J Mitra for $1 lakh under a non-exclusive agreement. As per the agreement, the company didn't had to pay any royalty amount to the innovator. Incorporated in 1969, J Mitra is considered a leading company in the production and marketing of medical diagnostic kits in India. The core technical team at J Mitra were guided by the group at the ICGEB to replicate the technology thus resulting in outcomes at their level. Talking about the project, Dr Navin Khanna said, â€œOur aim was to make a cost-effective product that is within the reach of the common people. J Mitra has showed real professionalism and dedication to create mass awareness about the product. This partnership would not have been a success without their participation.â€? The way forward So far, more than 500,000 Dengue NS1 Antigen tests have been used in the laboratories in India to diagnose and detect dengue infection, in some cases on the first day of fever. The tests priced at 6 per test, have been acknowledged by competitors for its quality and low prices. The low cost has prevented the entry of several Chinese diagnostic kits into the Indian market. Since the launch of the product in 2010, all imported dengue kits from the US, Australia and South Korea have been slowly disappearing from India. Praising the efforts of the Department of Biotechnology (DBT) in this direction, Dr Khanna said, â€œThe DBT has supported several public-private partnerships and made diagnostic kits highly affordable, thereby making India not only self-sufficient, but also an exporter of these kits. Because of this, several diagnostics kits from other countries have been replaced with indigenous kits.â€? Rahul Koul in New Delhi ]]> <![CDATA[Mission: An indigenous rotavirus vaccine]]> https://biospectrumindia.com/news/95/2208/mission-an-indigenous-rotavirus-vaccine.html https://biospectrumindia.com/news/95/2208/mission-an-indigenous-rotavirus-vaccine.html Mon, 13 Feb 2012 14:50:00 +0530 An exemplary partnership between Bharat Biotech, government agencies and research institutes, has made the dream of an indigenous vaccine for rotavirus come true KRotavirus is the leading cause of severe diarrhea in children worldwide. In order to improve access to better, affordable rotavirus vaccines and to prevent mortality, Bharat Biotech has produced a prototype vaccine of 116E, the most promising candidate under good manufacturing practices (GMP) conditions. This live attenuated oral vaccine, which is based on the rotavirus strain 116E, was co-developed by the present secretary of the Department of Biotechnology (DBT), Dr M K Bhan, in the 1980s. The vaccine is undergoing the final efficacy tests. The 116E human monovalent vaccine candidate is a naturally occurring re-assortant human strain with one gene (VP4) derived from a bovine rotavirus. The 116E strain was first isolated from an asymptomatic rotavirus-infected neonate in a hospital in New Delhi, India. The virus is grown on Vero cells, and the candidate has undergone extensive characterization and quality control testing at Bharat Biotech and other laboratories worldwide. The Hyderabad-based company's rotavirus vaccine development project is a public-private partnership with the Department of Biotechnology, Government of India; Society for Applied Studies, National Institute of Immunology; Translational Health Sciences Technology Institute; the Indian Institute of Science; and the All India Institute of Medical Sciences. The project was also backed by funding and expertise from the Bill and Melinda Gates Foundation, Program for Appropriate Technologies in Health, Centers for Disease Control, National Institutes of Health and Stanford University, US. Since 2001, PATH has also been part of the collaborative effort to develop and evaluate 116E, supporting Bharat Biotech in conducting early-stage clinical trials. PATH also supported the Society for Applied Studies (SAS) and the NII in close collaboration with the DBT and Bharat Biotech to prepare for a phase III efficacy trial. In June 2008, Bharat Biotech and India's SAS announced encouraging data from a phase I/II clinical trial in New Delhi, India. The trial evaluated two different dosages in nearly 400 infants and after three administrations, the results showed 90 percent protection or â€œimmunogenecity rateâ€?. â€œThe key to our success is our novel concepts in vaccine development and innovative manufacturing processes with public health in mind,â€? says Dr Krishna Ella, chairman and managing director, Bharat Biotech. The way forward With successful completion of phase I and II trials and encouraging results from phase III trials, Bharat Biotech on June 6, 2011, announced that ROTAVAC, India's first indigenously developed rotavirus vaccine, will be sold to global public markets and governments worldwide, including UN procurement agencies at around 50 ($1) per dose. The company is expecting the India licensure of the vaccine in 2014 and WHO pre-qualification in 2015 for supply to UN agencies. The vaccine is currently undergoing phase III clinical development for safety and efficacy in 8,000 subjects, one of the largest clinical trial ever conducted in India. Bharat Biotech has an installed capacity of 300 million doses and is well-positioned to manufacture and supply ROTAVAC to United Nations Children's Fund, Pan American Health Organization and other national immunization programs. â€œIn 2001, I made a commitment to the Gates Foundation to develop and supply a novel rotavirus vaccine at $1 a dose. We are extremely happy to honor that commitment. It is a reaffirmation of our commitment to make vaccines affordable globally,â€? says Dr Ella. Rahul Koul in New Delhi ]]> <![CDATA[Mission: Boosting efforts to combat hepatitis C]]> https://biospectrumindia.com/news/95/2183/mission-boosting-efforts-to-combat-hepatitis-c.html https://biospectrumindia.com/news/95/2183/mission-boosting-efforts-to-combat-hepatitis-c.html Mon, 13 Feb 2012 14:48:00 +0530 Utilizing BIPP support, Hyderabad-based RAS Lifesciences, in partnership with Institute of Liver and Biliary Sciences, New Delhi, is developing a unique cell culture-based replicon model for hepatitis C genotype 3 Known to be a silent killer, hepatitis C virus (HCV) is the leading cause of liver diseases in India. As compared to hepatitis C genotype 1, which is prevalent in rest of the world, genotype 3 affects a major chunk of the population in the Indian subcontinent. Currently, cell culture-based replicon models are only available for genotype 1 and 2, and there are no animal models or other in-vitro models for assessing the efficacy of drugs. Consequently, no vaccine or effective drug has been developed so far. To fill this vacuum and find an alternative, Hyderabad-based RAS Lifesciences, along with Institute of Liver and Biliary Sciences (ILBS), New Delhi, initiated a project for the creation of a specific model for 3a-based replicon system. The Biotechnology Industry Partnership Programme (BIPP) of the Department of Biotechnology, Government of India, was a major support for the company. The funding of about 32 lakh, with 50 percent of it as loan and the rest as grant, helped the company move forward on this particular project. â€œFunding is very important to keep start-ups like us motivated and to develop innovative and exclusive products to meet India-specific needs. BIPP funding has added a great amount of confidence to propose feasible ideas,â€? says Mr Bhishma Baru, head-operations, RAS Lifesciences. Set up in March 2008, RAS Lifesciences is focused on delivering cost-effective solutions for healthcare. The association of RAS Lifesciences with an institute like ILBS, which has an exclusive mandate for treatment and research on liver diseases, proved to be a perfect alliance to carry out translational research. While all the activities relating to amplification and cloning of 10-to-15 full length HCV genotype 3a sequences and generation of RNA by in-vitro transfection in hepatocytes (liver cells) are carried out at RAS Lifesciences, the team at ILBS is conducting transfection and generation of replicon model in cell cultures. The respective teams at both the organizations share the technical know-how and information on a regular basis. Talking about the relevance of PPPs, Mr Baru adds, â€œBiotech industry is capital-intensive. Hence, partnerships with public institutions are highly useful in getting products into the India market.â€? The way forward Considering the fact that there are no replicon models for hepatitis genotype 3 right now, the outcome is likely to work wonders and provides a ray of hope. The project that was initiated in March 2011 has seen rapid progress and results are encouraging. The product patents will be held by both companies and revenues will be shared equally. Excited about the outcome, Mr Baru says, â€œWith the expertise at RAS Lifesciences, we could finish cloning of 14 full lengths and sequencing for 10 clones. We are geared to finish the project well before the schedule.â€? Mr Baru also feels that start-up companies must not be seen at par with the well-established companies. â€œThe private companies are expected to contribute equally to the funding which has loan and grant components. This is a major problem for start-up companies. It would be of great help if, considering the scope and potential of the project, some relaxation is provided to start-ups.â€? Rahul Koul in New Delhi ]]> <![CDATA[Affordable cancer treatment Competition hots up]]> https://biospectrumindia.com/news/95/2674/affordable-cancer-treatment-competition-hots-up.html https://biospectrumindia.com/news/95/2674/affordable-cancer-treatment-competition-hots-up.html Mon, 13 Feb 2012 14:47:00 +0530 Big and small biopharma companies are trying to capitalize on the India oncology market via diagnostics, drug development and biosimilars. A report India accounts for 7.5 percent of the total new cases of cancer globally, with only China and the US ahead in reporting the emergence of new cases. With approximately one million cases and approximately eight percent fatalities each year, cancer is becoming a leading cause of death in India. According to the Cancer Foundation of India, cancer impacts up to 2.5 million people in India annually. Lung cancer among males, cervical cancer and breast cancer among females, and head and neck cancer in general are the most common cancers in India. The primary drivers are an aging population, changes in lifestyle, pollution and genetic causes among others. The current size of the anti-cancer market in India, according to Frost & Sullivan, is between 1,650 and 1,750 crore (2011). The market is expected to grow at a compound annual growth rate (CAGR) of 21 percent from 2008 to 2014, touching nearly 3,309 crore. In fact, drugs that are used to treat cancers have emerged as one of the fastest growing segments in the pharma sector, often outperforming the market in terms of growth. The future growth is being driven by the introduction of new treatments, increasing number of patients on chemotherapy and improved access to modern cancer therapies. Also, the shortfall in diagnostic infrastructure in India to combat cancer is huge. The top 10 drugs to treat cancers account for 70 percent of the market and the annual sales in 2009 for this class of drugs was estimated to be over 2,60,000 crore ($50 billion) and is expected to hit the 3,90,000 crore ($75 billion) mark by 2013. Commenting on the market potential, Dr Manu Jaggi, director, R&D, Dabur Research Foundation (DRF), says, â€œThe global cancer market will be primarily driven by the increase in sales of biologic drugs. The targeted drugs now appearing on the market should be just the first wave of new anti-cancer therapies. The repertoire will expand rapidly over the next five years as more targets are identified. Cancer vaccines have also seen a great deal of R&D investment with over 30 different cancers. Breast cancer will become most common cancer among Indian women by 2020.â€? Sharing his thoughts, Dr Shiladitya Sengupta, assistant professor of health science and technology, Harvard Medical School, US, says, â€œThe projections point to the fact that soon cancer is going to emerge as one of the biggest killer disease and close to 12.5 percent of the Indian population will die of cancer in the next 20 years.â€? Competition hots up Oncology remains the single largest therapeutic area for both large pharmas and start-up companies. According to Mr Ajaykumar Sharma, practice head, pharma and biotech practice, Frost & Sullivan, South Asia and Middle East, â€œGlaxoSmithKline (GSK) and Merck Sharp & Dohme (MSD) are leading the market crossing the billion dollar mark in sales. Each is witnessing a growth of 50 percent year-on-year in the cancer vaccine space.â€? According to reports, the sales of MSD pharmaceutical's Gardasil, used to tackle cervical cancer, is said to have increased 72 percent in 2010 as compared to 2009. At the same time, GlaxoSmithKline's Cervarix gained 60 percent market. Both are available in India, since they got approval from the Drug Controller General for sale in India for use by women aged between nine and 45 years. Pointing towards the fact that the oncology market is dominated by MNCs, Mr Ajaykumar says, â€œThe profits from sales for MNCs such as Roche, account for approximately 22 percent and Dr Reddy's Laboratories has approximately 13-to-14 percent of the share. Other top Indian companies in the segment include Intas Biopharma and Natco.â€? Besides big pharma players such as Bayer, Fresenius Kabi, Novartis, Pfizer, Roche and Sanofi-aventis, companies that have an active role in offering cancer treatment are Natco Pharma, Sun Pharmaceuticals, Dr Reddy's, Lupin, Cipla, Zydus Cadila, Biocon and Intas Biopharma. These are promoting products for the treatment of different cancers, including breast cancer, lung cancer, ovarian cancer, prostate cancer, head and neck cancer, cervical cancer, renal cell carcinoma and pancreatic cancer. At the same time, looking at the huge market potential and opportunities, many Indian companies such as Intas Biopharma, Biocon, Dr Reddy's Laboratories, Transgene Biotek, Inbiopro Solutions, IMGENEX, Panacea Biotec, Mitra Biotech, Bharat Biotech and Shantha Biotechnics, have also been working on developing new therapeutics, kits and drugs for many years. While some of them have already launched products, others are still at various stages of R&D. Biocon, the leading biotech company in India, launched BIOMAb EGFR, a humanized monoclonal antibody that falls under a class of cancer treatment option known as targeted therapy. The price of the product is said to be much lower than similar drugs available in the country. Dabur Pharma launched nanotech-based chemotherapy in India. This nanoscale drug delivery system for the widely used anti-cancer agent paclitaxel was the first-of-its-kind in the country. Nanoxel is a cremophor free water soluble formulation and is indicated as a safe therapy for advanced breast, non-small-cell lung and ovarian cancers. Dabur Research Foundation successfully developed a peptide-based anticancer drug for treating colorectal and periampullary cancers. Besides these, DRF developed a large oncology pipeline, including cytotoxics, anti-metastatics, biologically targeted drugs and phytochemicals for treating various cancers. Panacea Biotec, a leading vaccine player, in 2011, launched an anti-breast cancer product, albumin-bound Paclitaxel particles formulation drug, PacliALL. The product is available at a price, which is approximately 50 percent lower than competitive products in the domestic and global markets. The company is investing 55 crore on a commercial anti-cancer formulation facility at Baddi, Himachal Pradesh, expected to be licensed and operational this month. Chandigarh-based Venus Remedies, apart from its product 'Gemcitabine' currently in market and used in the treatment for cancer, also developed a novel formulation for targeted delivery. According to Dr (Mrs) Manu Chaudhary, joint managing director, Venus Remedies, â€œVenus has developed a novel formulation for the targeted delivery for increasing the specificity and the efficacy of anti-cancer drug, which would reduce the side effects of the therapy to a great extent. At present, the formulation is in pre-clinical stage.â€? Working towards affordable treatment With the increase in the incidence of people being affected by cancer, the focus is rapidly shifting towards developing novel drug delivery systems and combination therapies. The monoclonal antibodies (mAbs) are considered to be worthy candidates for developing a safe therapy, due to their specificity, as compared to chemo and radiation therapy. mAbs therapy in India is very expensive and out-of-reach of most cancer patients. â€œWhile targeted drugs are here to stay for at least another decade, stem cells hold tremendous potential for treating cancer. DRF has taken several steps to face the challenges ahead,â€? adds Dr Jaggi. Syngene International, a subsidiary of biotechnology major Biocon, entered into a discovery and development collaboration with US-based Endo Pharmaceuticals in order to develop novel biological therapeutic molecules against cancer. The company has also collaborated with a US-based start-up company, IATRICa, for creating a â€œtherapeutic vaccineâ€? that will help the body activate the immune system to fight cancer on its own, with technology developed at the Johns Hopkins University. IMGENEX India, which is based at Bhubneshwar, is developing a herceptin biosimilar, which will be available to Indian patients at an affordable cost. IMGENEX estimates that around 3,500 patients are responsive to herceptin, out of the 70,000 new breast cancer patients that are diagnosed every year in India. It is also developing novel therapeutic monoclonal antibodies for the treatment of prostate cancer in collaboration with Dr G P Talwar Research Foundation, New Delhi. The development of these antibodies is at a very early stage. The company is building a state-of-the art GMP facility in Bhubaneswar, Orissa, for production of biosimilar monoclonal antibodies and the same will be operational in mid-2013 with an initial investment worth approximately 20 crore. Dr Sujoy Singh, MD, IMGENEX India, says, â€œBreast cancer treatment using Herceptin mAb costs about 16 lakh per year. Most of the cancer patients in India cannot afford this treatment. Our goal is to make the monoclonal antibody therapy affordable to the masses. We expect to release our first product in the year 2014-15.â€? Gurgaon-based ARA Healthcare is working on cancer molecules, ARA I, ARA II and ARA III, which are viewed as valuable addition to the current line of therapy with high commercial potentials. The company is carrying out pre-clinical and phase I clinical development of ARA I, a novel anti-metastatic protein with a potential therapeutic effect in several cancer types. The company is also working on ARA II, a novel recombinant pro-apoptotic protein that helps in selective targeting of cancer cells with potential of wider application in variety of cancer types, including cancers of gastro-intestine, lung, ovaries, pancreas and gliomas among others. Furthermore, the company is also conducting trials of ARA III, a thrombopoietic growth factor. â€œIn the last two-and-a-half years, the pharmacological activities of these molecules have been studied. The process for commercial scale production and purification and formulation have been developed,'' says Dr Rama Mukherjee, MD, ARA Healthcare. Chennai-based Shasun Pharmaceuticals recently entered into a joint drug development agreement with Nanoparticle Biochem Incorporated (NBI), a spin-off company of the University of Missouri, and created a new joint venture, Shasun-NBI LLC. This will involve research on new therapy for treating late-stage prostate cancer for more than five years. The efficacy studies in mice with prostate tumors have demonstrated an unprecedented 85 percent reduction in tumour volume after administering a single dose of radioactive gold nanoparticle. According to Mr Abhaya Kumar, managing director, Shasun, â€œTo capitalize on the changing trends, Shasun will make a 7.8 crore ($1.5 million) initial investment to bring promising new nanotechnology for cancer treatment. We are now gearing-up to formulate nanomedicine kits at our FDA approved facilities as we still await the FDA approval for clinical trials in India and in the US. Hospitals in India and at the University of Missouri could be among the first to initially test the drug in pilot level clinical trials offering benefit for cancer patients.â€? LeadInvent, which is based at New Delhi in collaboration with the International Center for Genetic Engineering and Biotechnology (ICGEB), is working on the development of combination therapy for treatment of cancers with enhanced efficacy, particularly for resistant and non-responsive cancers. Another New Delhi-based start-up Invictus Oncology, aims to develop affordable and effective cancer drugs with a team of scientists already working in the area. Bangalore-based Mitra Biotech aims to personalize treatment option for cancer based on detailed molecular characterization and identification of key drivers of cancer progression and metastasis. The company is actively working towards the development of technology for cancer diagnostics. Venus Remedies developed a novel detection product for the early detection of cancer. This formulation has successfully undergone phase I and phase II clinical trials and now permission is awaited from the Drug Controller General of India (DCGI) for conducting phase III clinical trials. Recently Sanofi-aventis, and the Oxford University, UK, entered into an agreement to conduct multi-phase oncology clinical and translational research with INDOX, India's leading academic oncology network. Through this partnership and experience of India's top oncologists and scientists, clinical research would be conducted in accordance with the highest internationally recognized ethical standards. The researchers and doctors from the Indian Institute of Technology (IIT), Mumbai; LV Prasad Eye Institute, Apollo Hospitals, Hyderabad; and Tata Memorial Hospital, Mumbai; have researched and developed a nano version of an existing cancer drug, carboplatin. The new drug will reach the cancerous cells at a faster pace, reduce toxicity levels of chemotherapy and further increase chances of survival of the patient. Future forward Since the drugs developed in the West are very expensive and even generic versions have higher costs, the big question is that how many Indians can afford to go for the treatment. Hence the best way before India, seems to be proper planning and encouragement of the firms involved in oncology drug development. Mr Ajaykumar Sharma of Frost & Sullivan says, â€œAlthough oncology is the next game changer for the industry, the market is mainly import driven with MNCs dominating the market. We hardly see any R&D in cancer coming out of the Indian companies. This is because cancer research requires a huge investment and Indian companies do not have the cash flow. Indian companies are active more on the biosimilar front in oncology, which requires an investment of around 104 crore ($20 million) for research.â€? â€œCurrently we are a young country but after 20 years, the situation is going to change and we will have a much older population. Therefore, planning for the next 15 years is a must before it becomes an epidemic due to various lifestyle factors. This is the good time to start investing heavily in research and build up our capabilities for future. We need to create mechanism for industry to come out with innovation,â€? Dr Shiladitya Sengupta of Harvard Medical School points out. The burden on healthcare systems can certainly be lowered if diagnosis is done at the right time. Both preventive and post-treatment diagnosis can help to reduce the number of deaths as well as the recurrence of the diseases. While the recent proposal to reduce prices of oncology drugs by the government is expected to help the patients, it might affect Indian companies as there would be very less margins. However, looking at the market potential, Indian companies need to continue to put efforts in the segment. â€œI believe that in the coming years we will see tremendous advances in molecular diagnostics and therapeutics using off-patent chemical and biological drugs, especially therapeutic mAbs for treatment of cancers in India,â€? concludes Dr Sujoy Singh of Imgenex. Rahul Koul in New Delhi (with inputs from Nayantara Som in Mumbai) ]]> <![CDATA[In search of dengue vaccine]]> https://biospectrumindia.com/news/95/2789/in-search-of-dengue-vaccine.html https://biospectrumindia.com/news/95/2789/in-search-of-dengue-vaccine.html Mon, 13 Feb 2012 12:50:00 +0530 Dr Navin Khanna group leader, Mammalian Biology Division, ICGEB, New Delhi Dr Navin Khanna holds more than five patents in the diagnostics space and is one of those who has transferred the maximum number of technologies to the industry in the country. His current research on developing an indigenous dengue vaccine has raised many hopes and is being keenly followed by the government and the industry. After his PhD in biochemistry from the All India Institute of Medical Sciences (AIIMS), New Delhi, Dr Khanna moved to Canada and worked on cell regulation at the University of Calgary for three years from 1984 as an Alberta Heritage Foundation Fellow. Later, he shifted to the US and worked as a post-graduate research biologist for two years at the Center for Molecular Genetics, University of California, from 1987. Before returning to India in 1990, he worked as a research assistant professor for a year at the department of molecular biology and biochemistry, University of California. Since 1990, when he joined the International Centre for Genetic Engineering & Biotechnology (ICGEB), Dr Khanna has been working on genetically engineered bio-molecules for medical use. He has been instrumental in the development of novel recombinant designer proteins as inexpensive, highly sensitive and specific diagnostic intermediates for viral infections. The availability of recombinant clones for production of high quality diagnostic intermediates from his laboratory has reduced production costs of HIV, HCV and HBV diagnostic kits significantly. Diagnostic kits based on these proteins have been successfully commercialized. Manufactured in India by companies such as Bio-Med, Ranbaxy Laboratories, J Mitra, XCyton Labs and few others, these are not only being used in India but are also being exported to other Asian and African countries. One of his very promising projects is development of a sub-unit-based vaccine for dengue, which till now has no vaccine or antiviral drug. Most importantly, all the four serotypes of dengue viruses (DENV-1, -2, -3 and -4) that cause dengue are being taken care of in the project. His group is interested in developing sub-unit vaccines, based on DENV envelope domain III, that mediates virus entry into cells and elicits virus-neutralizing antibodies. Elaborating on this, Dr Khanna says, â€œCurrently, our research activities are focused on the development of experimental dengue tetravalent sub-unit vaccine in yeast. In consultation with the Indo-US Vaccine Action Program, we have created DENV-2 EDIII HBsAg virus-like particles (VLPs) and are evaluating these physically and functionally.â€? Besides, his present research activities are focused on genetically engineered biomolecules of medical use. He has developed a prototype dual assay for the simultaneous detection of HIV and HBV infections. Work is underway to build upon this to create a unique 3-in-1 assay for the simultaneous detection of HIV, HBV and HCV infections, in blood bank settings. His laboratory is also exploring the designer proteins for developing novel reporter assays using Terbium-labelled nanoparticles, in partnership with Prof Kim Pettersson at the University of Turku, Finland. For his outstanding contribution to the development of novel designer proteins as diagnostic intermediates of high sensitivity and specificity for detection of viral infections, Dr Khanna was honored with the Biotech Product & Process Development and Commercialization Award in 2011. Being a dedicated researcher, he has published more than 85 research papers and five reviewed articles in national and international journals and books. Calling the Department of Biotechnology (DBT) as the lifeline of the new mood of translating science for public good, Dr Khanna says, â€œI can recall several occasions on which sustained research support from DBT provided me the courage to change. I learnt how to think differently and dared to commercialize our research findings.â€? Rahul Koul in NewDelhi ]]> <![CDATA[Tailoring reagents to R&D needs]]> https://biospectrumindia.com/news/95/2876/tailoring-reagents-to-rd-needs.html https://biospectrumindia.com/news/95/2876/tailoring-reagents-to-rd-needs.html Mon, 13 Feb 2012 12:49:00 +0530 Dr Manjula Das CSO, Abexome Biosciences, Bangalore In a decade marked by many blockbuster drugs going off patent and the subsequent boom in biosimlars, the biopharma industry has displayed an accelerated pace of research in the field of biosimilars and biobetters. Leading from the front is Dr Manjula Das, chief scientific officer (CSO), Abexome Biosciences, who is also the co-founder and director of this company. Dr Das has an unique distinction of having worked only with biotech start-ups after her post doctoral research at McGill University, Canada, and MIT, USA. On her return to India, after a brief stint at the Indian Institute of Science, Bangalore, Dr Das became one of the first employees of Metahelix, now a leading bioagri company, where she helped set up the bioinformatics division. Dr Das then moved to another start-up, Connexios Life Sciences, as its CSO. Her experience at MIT, where she worked in a bioinformatics lab, helped her in using the software prediction tools and later validating those findings through experiments in the wet lab. It was during this time that she realized that there was a serious gap in the availability of necessary reagents in the market in India. This sparked the entrepreneurial spirit in her. â€œThe quality of the existing reagents did not suit our kind of research. We spoke to a lot of people from the scientific community and found that the problem was everywhere. That is how we started synthesizing antibodies ourselves at Connexios,â€? she says. â€œLater, we realized its potential for the biopharmaceutical market, and floated a separate company with the same investor.â€? Dr Das started Abexome Biosciences in 2007 along with Dr Sujan Dhar. According to Dr Das, Abexome Biosciences started out as an antibody company and then morphed into an assay company. Companies developing biogenerics or biobetters often need effective antibodies against the molecules they are developing at every step of the development pathway. This is where Abexome comes in offering services for the development of antibodies and assays for a protein. These antibodies are not humanized for therapeutic use but are used as reagents against peptides of 2kDa to 125 kDa for various functions, such as for detecting the distribution of the protein, its purity and its retention time in biological matrices. Dr Das believes that the services aspect of the company not only guarantees a steady income but also helps them learn and improve their techniques apart from understanding what the market requirements are. This has led to the development of products such as an assay for pentosan polysulphate, a drug sold under the commercial name of Elmiron. It is the only drug approved by the USFDA for the treatment of interstitial cystitis or painful bladder syndrome. â€œCurrently, there isn't any antibody available in the world against it. It took us almost a year to generate and standardize that assay where we synthesized a polyclonal antibody specifically for the pharmacokinetic analysis in human matrices and validated it in different labs all around the country. In this case even though the patent expired in 2010, no proper reagents were present and hence no generic molecule has come out yet,â€? she says. Outlining Abexome's future plans, Dr Das adds, â€œWe have developed an antibody for PEG-GCSF, which will be launched this month along with an assay for any PEGylated molecules. Currently, there is no PEG-GCSF kit in the world. Most biobetters are molecules that are mostly PEGylated to improve their half life, thus offering a lot of scope for the assay.â€? Manasi Vaidya in Bangalore ]]> <![CDATA[Making NCE a reality in India]]> https://biospectrumindia.com/news/95/2820/making-nce-a-reality-in-india.html https://biospectrumindia.com/news/95/2820/making-nce-a-reality-in-india.html Mon, 13 Feb 2012 12:47:00 +0530 Dr Sivaramakrishnan president, R&D, Piramal Life Sciences, Mumbai The life sciences industry in India is witnessing exciting times, with a paradigm shift in its image as a low-cost drug development destination to being a prospective drug discovery hub. As the industry waits with baited breath for the commercialization of India's first new chemical entity (NCE), scientists and researchers at Piramal Life Sciences, a research-driven organization of Piramal Healthcare focusing primarily on NCE research, are leaving no stone unturned to make this endeavor a reality. Dr Sivaramakrishnan, president, R&D, Piramal Life Sciences, plays a proactive role in the company's drug discovery pursuits. â€œDrug discovery is not for the faint-hearted. It requires patience and long time commitment not just from the company but also from the scientists,â€? he says. At Piramal, his research interests extend from being a process chemist looking into APIs and contract research to looking into drug discovery with medicinal chemistry along with other facets like biology and toxicology. â€œMy focus extended to the domain of drug discovery. Working in this organization helped me in learning and experiencing how a new drug is discovered and developed subsequently. This has converted me into a big supporter of the product patent regime,â€? says Dr Sivaramakrishnan. When he joined Piramal, the company had taken a call to work in three disease areas â€“ oncology, inflammation and metabolic diseases. At that time, it had the best natural products collection and the team explored that for newer compounds. Today, the company has three compounds in clinics in oncology, three compounds in clinics in metabolic diseases and one compound in inflammation diseases.Piramal is also into discovering potent CDK inhibitors. Its lead chemical compound in oncology, a Cdk-4 inhibitor, has completed two phase I studies and is being tested in another phase I/II trial for multiple myeloma. â€œOur goal is to launch our lead product in oncology by 2013,â€? he adds. Trials for these compound are being conducted in India, the US, Canada, Australia and New Zealand. Also, the Department of Biotechnology (DBT) and Piramal have begun phase II of their drug discovery public private partnership to find new drugs from 14,000 bioactive cultures discovered in a nationwide search of biodiverse habitats in collaboration with nine national institutes. Dr Siva, as he is popularly known, is very passionate about this project. A total of 245,000 different microbes were collected and characterized at the national centers. Extracts from these microbes were screened for biological activities across four different therapeutic areas, namely cancer, diabetes, inflammation and infectious diseases. Based on the results of these studies, the team identified more than 14,000 cultures that showed potent activities in the above disease conditions: 5000 extracts for anti-infective, 500 extracts for anti-cancer, 6000 for anti-diabetes and 2900 extracts with anti-inflammatory properties. All these cultures are in the process of classification and storage in a national repository created by the DBT at the National Center for Cell Science. Dr Sivaramakrishnan has had an impressive career of more than 25 years in the industry. He has amassed a wealth of experience in process chemistry making international Drug Master File (DMF) dossier filings for regulated markets such as the US and Canada, has hands on experience in contract research and manufacturing services and in filing process patents of active pharmaceutical ingredients (APIs) and has also delved into medicinal chemistry and drug discovery work. â€œI am part of a developing industry where, when I started my career, it was about doing what multinational companies asked for and now it is at a stage when the pharmaceutical industry in India is making its own drugs, patents and new processes,â€? he says. Dr Sivaramkrishnan did his M Sc degree from St Xaviers College, Mumbai. After a three-year stint at Colour-Chem, he pursued a doctoral degree in synthetic organic chemistry from the University of New Brunswick, Canada. A post doctoral stint at the University of Pennsylvania, Philadelphia, followed where the first seeds of interest in development chemistry was sown within him. Dr Sivaramakrsihnan returned to India in 1984 to join Searle India (now RPG Life Sciences) where he met his mentor Dr K Nagarajan. Dr Nagarajan, a reputed organic chemist, was then the director of research at the company. For four years, Dr Sivaramakrishnan worked in pharmaceuticals and agrochemicals before moving back to Canada to pursue his post doctoral in synthetic chemistry from the Universite de Montreal. His desire to work in India brought him back to the country towards the end of 1991. He joined Bangalore Pharmaceutical and Research Laboratories (BPRL), then a young start-up. According to him, working at BPRL was his greatest learning experience. He had the opportunity to set up a research laboratory from scratch for both chemistry and pharmaceutical formulations. Together, they set up one of the best labs in Bangalore for API, pharmaceutical formulation and analytical research with pilot plants. In 2000, the BPRL, rechristened as Recon in 1995, was hived off in two parts. The formulations part went to Zydus Cadila and the API business went to Hikal. Dr Sivaramakrishnan joined Hikal, where he continued his work on APIs and was involved in the filing of patents for one of the very large volume APIs, making dossiers for the US. He was also involved in setting up a plant that was later approved by the USFDA. In 2003, Dr Sivaramakrishnan met Dr Somesh Sharma, MD, Piramal Life Sciences, and subsequently joined as its head of process research. Dr Sivaramakrishnan works closely with Piramal's collaborative projects with Eli Lilly and Merck. He is also in the advisory committees of a few reputed colleges and government laboratories and is a recognized PhD guide for Mumbai and Mysore universities. Last year, he was admitted as a Fellow of the Royal Society Of Chemistry, UK. Nayantara Som in Mumbai ]]> <![CDATA[Quality assurance is key]]> https://biospectrumindia.com/news/95/1594/quality-assurance-is-key.html https://biospectrumindia.com/news/95/1594/quality-assurance-is-key.html Mon, 13 Feb 2012 12:42:00 +0530 Biologics manufacturers are striving hard to adhere to international quality standards. Better regulatory policies by the government will go a long way in aiding the industry In recent years, licensing and quality control for manufacturers and national regulatory authorities has become more complex. The National Institute of Biologicals (NIB) has been working since 1992 as an autonomous organization under the Ministry of Health and Family Welfare, Government of India, to strengthen the regulations on biologicals in India. The institute assures and reviews quality of biological products available through domestic manufacturers and importers. The operations are carried out in the state-of-the-art facility of the institute and in close co-ordination with government regulatory authorities, such as the office of Drug Controller General of India and the Indian Pharmacopeia Commission. Indian companies are ramping up their facilities in adherence to quality standards for both the regulated and unregulated markets of the world, but they still have a long way to go. â€œOne area that could be improved upon is the availability of more current good manufacturing practices (cGMP)-approved manufacturing facilities,â€? says Mr Chinny Rao, executive director, Transgene Biotek. â€œThis can sometimes sit alongside a dearth of knowledge concerning the exact standards and parameters prescribed by foreign regulators, and the absence of government support in dealing with or overcoming foreign government restrictions on imports. In commercial terms this just adds to delays in manufacturing time lines and also cost increases.â€? Quality is priority Companies dealing in biologicals say adhering to quality parameters is of utmost importance to them. Dr Esmail Samiwala, senior VP, USV, says USV's focus is to maintain the highest quality standards at all stages. â€œUSV believes in the concept of one quality and one development for both regulated and semi-regulated markets. The EU and the US cGMP standards along with Indian GMP standards are strictly adhered to while manufacturing at both drug substance and drug product manufacturing plants,â€? he says. The companies, as a part of their yearly training calendar, provide training to employees on-the-job to maintain quality standards. Updating employees about the regulatory requirements and ensuring that the new standards are implemented in a time-bound manner are regular practices at all manufacturing plants. Mr Chinny Rao, says, â€œIn addition to regular internal auditing of our facilities and processes, we also adhere to cGMP, ISO and EU guidelines as standard practice.â€? India's biggest vaccine manufacturers, such as Serum Institute of India in Pune, Panacea Biotec in New Delhi, and Bharat Biotech in Hyderabad, who manufacture a variety of biological products, follow quality parameters strictly. As a result of this, these firms have emerged as major exporters, matching international quality expectations. The quality audits have been part of the regular programs in order to ensure that overall quality concerns of the companies are addressed. At Panacea Biotec, vaccines account for about 70 percent of revenues. It has ultra-modern production facilities complying with international standards and cGMP. Similarly, Bharat Biotech International too has been observing the highest quality standards at its manufacturing units. â€œWe are aware that our products are administered to children and adults worldwide. We have to maintain the highest standards of quality. Absolutely no compromise will be tolerated at Bharat Biotech for quality,â€? says Dr Krishna M Ella, CMD, Bharat Biotech. The biopharmaceutical manufacturing facility at Reliance Life Sciences in Mumbai is already approved by the European Medicines Agency (EMA). Mr KV Subramaniam, president, Reliance Life sciences, says, â€œThe manufacturing facilities at Reliance Life Sciences are built as per US Food and Drug Administration (FDA) and EMA standards.â€? â€œGetting the pre-qualification approval from the WHO for Shan5 is a high priority for us. We are working towards making the necessary changes so that we can start supplying it by 2014 to the concerned agencies. We hope to start bidding for the tenders for the pentavalent vaccine in the next round.â€? - Dr Harish Iyer CEO, Shantha Biotechnics â€œThere have been certain disruptions, but I am confident that we will bounce back in 2013. We have initiated corrective and preventive measures to ensure compliance with the WHO pre-qualification guidelines and are in touch with the WHO in this respect. We are confident that with these corrective and preventive measures, we will be able to get re-listing of our pentavalent vaccine in the list of WHO pre-qualified vaccines.â€? - Dr Rajesh Jain joint managing director, Panacea Biotec â€œWe are aware that our products are administered to children and adults worldwide. We have to maintain the highest standards of quality. Absolutely no compromise will be tolerated at Bharat Biotech for quality.â€? - Dr Krishna M Ella CMD, Bharat Biotech â€œThere are many local and international companies in the Indian market and price erosion across all products is a problem. Because of the evolving Indian regulatory system, players who launched their products about four-to-five years ago were spending less on development as compared to the present costs of development. With the existing regulatory system, the cost of development and time spent on it are increasing manifold.â€? - Dr Esmail Samiwala senior VP, USV Talking about his company, Dr Cyrus Karkaria, president, biotechnology, Lupin, â€œLupin adheres to quality demanded by developed markets because at the end-of-the-day that is where we want to be and we are striving to get there as soon as possible. The opening up of the US biosimilar pathway would lead to a world of opportunities for companies, such as Lupin, in India.â€? Setback in quality In the recent past, there have been instances where some of the major companies dealing in biologics have suffered setbacks in quality adherence. In April 2010, the WHO ordered recall of Shantha Biotechnics's pentavalent vaccine, Shan5, from the market after finding some white sediments in the vials of certain samples. The recall was ordered as a precautionary measure. Shan5 is a DTwP-hepatitis B-Hib vaccine. Speaking about the current status of Shan5, Dr Harish Iyer, CEO, Shantha Biotechnics, says, â€œGetting the pre-qualification approval from the WHO for Shan5 is a high priority for us. We are working hard towards making necessary changes, so that we can again start supplying it by 2014 to the agencies. We hope to start bidding for tenders for the pentavalent vaccine in the next round.â€? In August 2011, Panacea Biotec, which was among the first companies to launch a pentavalent vaccine, had their WHO pre-qualification approval withdrawn after a routine audit due to inadequate quality assurance processes. The statement by the WHO states that EasyFive was not found to be unsafe, but procurement was to be stopped until the manufacturer implemented corrective measures. Reacting to it, Dr Rajesh Jain, joint managing director, Panacea Biotec, says, â€œThere have been certain disruptions, but I am confident that we will bounce back in 2013. Our performance has been affected by the delisting of pentavalent vaccine from the WHO's list of pre-qualified vaccines, following a routine site audit by a WHO team in July 2011.We have initiated corrective and preventive measures to ensure compliance with the WHO pre-qualification guidelines and are in touch with the WHO in this respect. We are confident that with these corrective and preventive measures, our pentavalent vaccine will regain its WHO pre-qualified vaccine status.â€? Bharat Biotech, one of the major exporters of vaccines to international organizations such as the WHO, too adheres to the highest quality standards. But, in 2011, the WHO suspended supply of its hepatitis B vaccine through UN procuring agencies after it found deficiencies in the implementation of good manufacturing practices and quality management of the company during a site audit of a production plant at Hyderabad. The WHO, however, did not recommend recall of Revac-B+ that was already distributed, since the suspension was precautionary and an interim measure. Regulatory landscape requires reforms Delay in approvals after submission of dossiers to regulators is a pain point for the industry. Mr Chinny Rao of Transgene Biotek says that advantages of manpower availability and lower costs of manufacturing, which gives the industry in India its underlying momentum, can sometimes get â€œoutweighed by certain localized disadvantages, most of which typically relate to bureaucracyâ€?. Challenges Reference standard not available in time: For example, official monographs of filgrastim, interferon and erythropoietin were included in pharmacopoeia in 2007, but reference standard is not available yet. No chapters or guidance for finished products: All requirements mentioned in pharmacopeia monographs are in place for drug substance only. Specifications more relaxed than innovator product: Quality requirements by pharmacopoeial authorities are considerably different in approved drugs and contradictory to biosimilars requirement. Manufacturers can use monograph for evaluation of quality of product for release purpose. However, compliance to monograph is not sufficient when purpose of the study is to establish biosimilarity. Source: Kemwell India The lack of standard procedures on what needs to be done to attain regulatory clearance by companies in India and abroad is a major drawback. The company heads are of a view that a haphazard approach by a few officials to set criteria that companies must clear to get green signal is not at all helpful. â€œIt's a little bit of guessing on both sides, which in turn means that time is wasted in exploring or researching what you think will be required. Furthermore, if you have export aspirations, this can add to the workload because more often than not what is generally required here is what will be expected in foreign markets as well. And the absence of standard practice often means having to go back and forth wasting precious time and resources,â€? adds Mr Rao. Pointing towards the lack of clarity on stem cells and biosimilars, Mr KV Subramaniam, president, Reliance Life Sciences, says, â€œIndia does have a biosimilar regulatory framework in place. But for stem cell-based therapies, such a framework is obscure. For biosimilars, current guidelines are quite stringent and, therefore, any biosimilar player faces challenges in terms of longer clinical development time lines and higher development costs.â€? One of the challenges of biologics manufacturing here in India has been the absence of government support to what is a fledgling industry. All countries, where the pharmaceutical and biotech industries are very successful, have a single regulatory agency. As compared to that, India has a rather complex structure with many agencies, such as the Drug Controller General of India, the Review Committee for Genetic Manipulation, the Genetic Engineering Appraisal Committee, and the Directorate General of Foreign Trade (DGFT) among others. â€œIndia has a strong biologics regulatory framework that involves four-to-five ministries in the Government of India and many agencies that jointly regulate the development, manufacture and supply of biologics. It makes for a very complex regulatory system. Comparatively, all countries where the pharmaceutical and biotech industries are very successful, have a single regulatory agency such as the EMEA (in Europe), the FDA (in the US), TGA (in Australia) and ANVISA (in Brazil), which oversee and regulate all aspects of the industry,â€? says Dr Krishna Ella of Bharat Biotech. Sharing a similar view, Dr Samiwala of USV says, â€œDevelopment of products for the Indian market is a little different when compared with the development program of Europe. The difference is in the number of times regulatory submissions during the development and time lost in follow-ups. Apart from this, there is some non-clinical and clinical development requirements specific to India. As the company's thirst is to reach other semi-regulated and regulated markets, merging the development programs for India and other markets is the biggest challenge.â€? Dr Hemanth Nandigala, director, Virchow Biotech, has a different view. â€œContrary to common belief on hassles, we feel that India has an excellent biological regulatory approval system. We have been operating across multiple markets and we can say this with reasonable experience,â€? he says. On an optimistic note, Dr Cyrus Karkaria, president, biotechnology, Lupin, says, â€œThere have been delays but most of the times they have been pre-empted by engaging the regulatory forces. They have been co-operating with the industry by coming up with a separate set of guidelines. Once those guidelines are out, then the process would be more seamless and understood clearly.â€? Rahul Koul in New Delhi ]]> <![CDATA[India in capacity building mode]]> https://biospectrumindia.com/news/95/4189/india-in-capacity-building-mode.html https://biospectrumindia.com/news/95/4189/india-in-capacity-building-mode.html Mon, 13 Feb 2012 12:39:00 +0530 The industry is set to take on the patent expiry with manufacturing capabilities for monoclonal antibodies, biosimilars, and recombinant proteins Many companies prefer to outsource their manufacturing processes to contract manufacturing organizations (CMOs) to meet their manufacturing requirements. However, an emerging trend in the industry has been companies setting up their own facilities to do so. A number of companies including Reliance Life Sciences, Virchow Biotech, Bharat Biotech and USV believe in producing biologics on-site and constantly update their manufacturing capabilities to keep up with the growing pipeline of products. Mr K V Subramaniam, president, Reliance Life Sciences, talks about the reason behind doing so. â€œReliance Life Sciences has taken upon itself to build India's largest mammalian cell culture facility, which is also approved by the European Medicines Agency (EMA). Therefore, Reliance Life Sciences has the requisite capabilities and capacities to manufacture biosimilars on a commercial scale and at competitive costs. Hence, we do not outsource any production-related requirement and ensure all product manufacturing is done in-house,â€? he says. â€œThe biopharmaceuticals manufacturing facility is capable of producing microbial products at 1,000 liters scale and mammalian cell culture-based products at 10,000 liters scale,â€? he informs. Other firms such as Transgene Biotek, believe in augmenting the services offered by the CMOs to their existing facilities to produce biologics. Mr Chinny Rao, executive director, says, â€œAs we are predominantly an R&D-driven company, we see our new found manufacturing expertise and skills as an effective hedge against the applied risk that we have in our large molecule innovation pipeline. And in understanding this, we've started to add capacity to our existing set-up and are just weeks away from the completion of a new unit, consisting entirely of fermenters and down-stream processing units that will augment our existing arrangement with our CMO partners.â€? In order to be able to utilize their own manufacturing facilities, companies need to expand their existing facilities within a few years to cater to the growing demand. Dr Hemanth Nandigala, director, Virchow Biotech, says, â€œFor every manufacturer, an improvement in manufacturing processes and systems, and up-gradation of analytical capabilities is an ongoing effort. It is no different for us. As we continue to build skill sets in systems and controls for biological manufacturing, we believe that the opportunities would open up for us as more patents expire.â€? Dr Cyrus Karkaria, president, biotechnology, Lupin, echoes the fact that the impending patent cliff will have a strong impact on the manufacturing practices in our country. He emphasized the need to think ahead and take into account market scenarios. Investing in contract biologics manufacturing Advantages Access to capacity Access to scale Access to competencies Access to technologies High expression cell lines Lower risk of batch failure Lower cost (when service provider is in emerging market) Disadvantages Risk of cost increases Lower control over schedule Dependency on CMOs for audit clearances when lacking experience Variability in delivery standards Expensive technology transfers Additional work in technology transfer based on facility compatibility â€œWe have already invested in our facilities and are investing a lot more in manufacturing right now, so that we can gear up for the huge patent cliff happening in the West. We have some products that should be launched this year, so we have adequate capacity for manufacturing those drugs. We will increase our capacity accordingly when we see an increase in sales of those drugs,â€? he says. Another such company that is expanding in order to meet market requirements is USV. Dr Esmail Samiwala, senior VP, USV, says, â€œUSV is investing more than 80 crore in upgrading the drug substance manufacturing facility. This would mean a ten-fold increase as compared to the existing capacities. Present manufacturing capacity of drug substance is more than 100gm per batch with the total capacity of drug product manufacturing facility being about 30 million injections annually,â€? he says. In the pipeline Most people perceive the Indian biologics manufacturing scenario to be mainly consisting of the biosimilars space. Others believe that Indian firms are working on only those compounds that are going off the patent cliff. However, a lot of the companies are actively working to innovate and develop methods to indigenously produce recombinant proteins, vaccines and monoclonal antibodies. Dr Krishna Ella, CMD, Bharat Biotech, presents a positive picture. â€œWe are currently focused on novel innovative products such as REGEN-D (wound healing) and Lysostaphin (MRSA anti-infectives) among others,â€? he says. Similarly, Dr Samiwala says, â€œThis year, USV is planning to launch the first indigenously developed somatropin for injection and Teriparatide injection in the India market. USV's drug product manufacturing facility is capable of producing a significant percentage of the total Indian and regulated market requirement.â€? Similarly, Transgene Biotek is enthusiastic about the production of docosahexaenoic acid (DHA), an omega-3 fatty acid that was recently initiated in October last year and whose technology was developed indigenously. A positive outlook Most companies are projecting a positive outlook for the next few years through their expected growth rates. Dr Ella says with new products in the pipeline, he is targeting a revenue growth of 25 percent in the biologics space for Bharat Biotech. Lupin is also very positive about the returns from their pipeline of seven-to-eight products, which they hope to commercialize in the next few years (including a host of biologics). Other companies such as Virchow Biotech and Transgene Biotek too are also looking at a growth rate of around 30 percent. Constant innovation coupled with smart manufacturing practices and rigid adherence to cGMP standards seem to be the order of the day as most companies are looking to expand their portfolio as well as their manufacturing capacities. Manasi Vaidya in Bangalore ]]> <![CDATA[India on biologics trail]]> https://biospectrumindia.com/news/95/2557/india-on-biologics-trail.html https://biospectrumindia.com/news/95/2557/india-on-biologics-trail.html Mon, 13 Feb 2012 12:36:00 +0530 With its low costs and skilled manpower, India makes an ideal destination for manufacturing biologics. Biotech companies are ramping up their facilities and quality standards to meet the patent expiry challenge. All that is needed is government regulations to match up. BioSpectrum takes a look at the industry's preparations and the hurdles on the way The Indian biotechnology industry, which clocked total annual revenues of 20,000 crore ($4 billion) for FY 2010-11 (BioSpectrum-ABLE top 20 survey 2011) is slated as one of the fastest growing knowledge-based sectors in the country and is predicted to have a significant impact on the overall global landscape. The year 2012 has brought a world of opportunities for Indian biotech companies, with big-wig biotech firms in the West facing a spree of patent expiration of their blockbuster products. Gradual expiry of patents will create significant market opportunities for developers through to 2016. Opportunities for India are mainly in areas such as biosimilars, vaccines and recombinant therapeutic products. Indian companies are leaving no stone unturned to expand their manufacturing capabilities. Adherence to current good manufacturing practices (cGMP) standards is high on their priority list. A large chunk of the Indian firms are also looking at contract manufacturing of biologic products for western companies. The contract manufacturing organization (CMO) market is a growing market in India and is expected to grow at an average of 20 percent in the coming years. Primary players in the CMO space include Piramal Healthcare, Jubilant Life Sciences, Strides Arcolab, Shasun, Dishman Pharma and Divi's Laboratories who have established their infrastructure facilities for the job.  Patent expiry and the market  Between 2012 and 2019, the market will see a patent expiry of a whopping 300,000 crore ($60 billion) worth of biotech drugs with Amgen being the most hard hit of all the companies. Its blockbuster drug for anemia, Epogen, which had a sale of about 12,500 crore ($2.5 billion) in 2008, will lose its patent in 2013. Another blockbuster drug Neupogen will lose its patent in 2013, while arthritis drug Enbreal will lose its patent in 2012. Epogen, Neupogen and Enbrel together account for half of Amgen's total revenue. Back in 1997, Hyderabad-based Shantha Biotechnics introduced the first indigenously produced hepatitis-B vaccine, Shanvac-B. Since then, there has been no looking back. They have bolstered their manufacturing capabilities for recombinant DNA products and have maintained a healthy pipeline of products in the space, and once commercialized, they are also looking at exporting these products, mainly to the emerging markets of the world. At present, there are 20 recombinant therapeutic products approved for marketing in the Indian market. â€œThe biopharmaceutical industry in India is expected to see strong growth in 2012, driven by growing markets, several new biosimilar product launches, exports of biosimilars and product-based partnerships,â€? says Mr KV Subramaniam, president, Reliance Life Sciences. Today there are around 25 Indian biosimilars players in the space with around 50 products in the market in the country. Some are also being sold in the unregulated markets. Indian biotech organizations are also bullish on the vaccines market and are making significant contributions to both the domestic and international markets. This has led many of the homegrown companies to set up state-of-the-art manufacturing facilities and a chunk of the volume produced there are exported to global regions and non-institutional organizations, such as the World Health Organization, GAVI and PATH. The vaccine market had an estimated sales of 2,180 crore for the previous fiscal and they account for 50-to-60 percent of the total biopharma market. Biologics manufacturers and their products Company Segment Major products manufactured in India Serum Institute of India Vaccines Bacterial vaccines, viral vaccines, recombinant and combination vaccines, Meningococcal A conjugate vaccine Wockhardt Biosimilars Glaritus (24-hr insulin analog), Wosulin (recombinant insulin), Wepox (erythropoietin) and Biovac-B (hepatitis B vaccine) Zydus Cadila Biosimilars /Vaccines Products still in pipeline which include G-CSF, PEG-GCSF, MABs, EPO / vaccines for infectious diseases. Main vaccine in recent past being VaxiFlu CPL Biologicals Vaccines, Biosimilars and Diagnostics Streptokinase, Anti-Rabies Serum, VISIAL, Halonix (Sodium Hyaluronate) Reliance Life Sciences Biosimilars ReliFeron (recombinant Interferon a), ReliPoietin (recombinant Erythropoietin), ReliGrast (recombinant GCSF), MIRel (recombinant Reteplase - tissue plasminogen activator), FostiRel (FSH), ReliBeta (recombinant Interferon beta-1a), ChorioRel (recombinant chorionic gonadotrophin hormone r-hCG) USV Biosimilar This year, USV is planning to launch first indigenously developed Somatropin for injection and Teriparatide injection in the India market Lupin Biosimilar Undisclosed â€“ to launch a biological product this year Biocon Biosimilar, recombinant proteins Insugen and Basalog (Human Insulin), Erypro (Erythropoietin), Streptokinase, Nimotuzumab (humanized anti-EGFR monoclonal antibody), Statix (anti-cholesterol) Transgene Biotek Biosimilar, recombinant proteins TrabiDHA(DHA), Tacrolimus, Orlistat Virchow Biotech Recombinant biopharmaceuticals Hyorth (osteoarthritis), Hyopt (ophthalmology), wound care products Shantha Biotechnics Vaccines ShanChol (cholera vaccine), Shanvac-B (Hep B), (vaccines for rotavirus, HPV, hexavalent vaccine in pipeline), Shantetra (DPT, Hep B vaccine), Shanferon (interferon a 2b) Bharat Biotech Vaccines Comvac5 (Fully liquid pentavalent vaccine- DTWP+Hep B+Hib), Revac-B (Cesium chloride-free recombinant Hep-B vaccine), Typbar (typhoid vaccine), Indirab (anti-rabies vaccine), Bio-HCG (human chorionic gonadotrophin), Biopolio (Poliomyelitis vaccine), Regen-D (recombinant human epidermal growth factor gel) Panacea Biotec Vaccines Recombinant Hep B vaccine, Ecovac4 (Quadruple vaccine-DPT+HepB), Easyfour (Tetravalent vaccine -DPT + Human Influenza Type b oligosaccharide), OPV (Trivalent, Monovalent- Type I & Type III, Bivalent) Indian Immunologicals Vaccines Abhayrab (purified vero cell rabies vaccine), Abhay-Vac (MMR vaccine), Elovac-B (Hep B vaccine), Raksha and Raksharab (FNMD vaccine), Bruvax (Brucella arbotus vaccine) Bharat Serums and Vaccines Recombinant proteins Rhoclone (anti-Rho-D immunoglobulin injection), Tetglob (tetanus hyper immune globulin (human) Foligraf (recombinant FSH), Bactovan (Amoxicillin + Clavulinic acid injection) Zenotech Labs Recombinant proteins Macrogen (huGM-CSF), Nugraf (G-CSF) Shreya Life Sciences Recombinant biopharmaceuticals Htrop (human chorionic gonadotropin), Ftrop (urofillitropin), Oral- Recosulin (insulin), Glycifit â€“ Metformin (oral antidiabetics) Advantage India Industry experts are unanimous in their opinion that this is the right time for companies to set up manufacturing bases in India. â€œOverall, India is still a great place to be located in at this juncture. The availability of manufacturing talent combined with the entrepreneurial zeal that pervades this economy make India the place to be in right now,â€? says Mr Chinny Rao, executive director, Transgene Biotek. Rise in demand, increase in the purchasing power of the masses and a growing population, have contributed to the boom in biologics manufacturing in the country. â€œThe advantage in India is that the market is growing in volume as well as in revenue due to increasing awareness about the safety of therapeutic recombinant biotech products among doctors, and reduced cost of the therapy is increasing affordability of these high-end medicines,â€? says Dr Esmail Samiwala, senior vice president, biologics, USV. This coupled with skilled talent and cheaper costs make India the hot bed for biologics manufacturing. Dr Cyrus Karkaria, president, biotechnology, Lupin, highlights this. â€œMost importantly, India has a large chunk of English-speaking skilled and well-educated workforce,â€? he says. Although the quality of manufactured products is the same, India has an upper hand against its Asian counterparts in terms of both pricing and skilled talent. â€œFor example, in countries such as Singapore, the pricing structure offered for manufacturing is the same as that in the West. Moreover, they have an educated workforce, but not a critical mass. There are biotech companies setting up facilities in those markets too, but those facilities are mainly for local markets,â€? says Dr Karkaria. Indian biotech companies are also gradually realizing the need for adherence to quality standards in order to compete in the global landscape. â€œIndian firms have a deep understanding and experience of cGMP for chemistry-based pharmaceutical product manufacturing. Indian firms should have an advantage in quickly understanding the need and in building these practices into their biologics operations,â€? says Mr Bart Janssens, partner and director, The Boston Consulting Group. Mr Chinny Rao of Transgene Biotek, while speaking about the issues concerning quality control processes, says, â€œThe fact that the number of FDA-certified facilities in India are on the rise indicates that standards are also rising.â€? The good news is that unlike in the recent past, Indian biotech companies are now positive about the regulatory structure for biologics. â€œThe current regulatory system for approval of biotech products allows a faster and more defined access to the market,â€? says Dr Hemanth Nandigala, director, Virchow Biotech. Nayantara Som in Mumbai ]]> <![CDATA[Pentavalent vaccines: A new era in immunization]]> https://biospectrumindia.com/news/95/4345/pentavalent-vaccines-a-new-era-in-immunization.html https://biospectrumindia.com/news/95/4345/pentavalent-vaccines-a-new-era-in-immunization.html Mon, 13 Feb 2012 12:33:00 +0530 In a move that would change the history of immunization in India, the Central government has started administering pentavalent vaccine in place of the existing DPT vaccine in a phased manner in Kerala and in Tamil Nadu. BioSpectrum explores the current scenario in the midst of doubts about the need for the pentavalent vaccine On December 14, 2011, a two-and-half-month-old baby was administered the first pentavalent vaccine as part of the Universal Immunization Programme (UIP) in India. The event marked a change in the Indian government's policy on vaccines. The inclusion of pentavalent vaccine would replace the existing trivalent DPT (diphtheria, pertussis, tetanus) with a new vaccine that will offer immunity against hepatitis B and haemophilus influenza Type B apart from the three mentioned above. After the World Health Organization (WHO) recommended that pentavalent vaccine be administered to every child in the world, the Government of India asked the National Technical Advisory Group on Immunization (NTAGI) to study the need for HepB and Hib vaccines in the Indian population. The NTAGI, in response, submitted a report in July 2008 recommending the introduction of Hib vaccine in all states as early as feasible and to adopt it under the UIP. The NTAGI report quoted the studies carried out in India that reported case fatality rates of Hib meningitis to be 20-29 percent, while all invasive Hib diseases (including meningitis) have a fatality rate of 16 percent. The NTAGI recommended the use of Hib vaccine as it has the potential to prevent over 70,000 deaths of children below five years of age. Ms Mahima Datla, senior vice president, Biological E, Hyderabad, which is the largest supplier of the DPT vaccines to the government, welcomes the government's move. â€œThe introduction of the pentavalent vaccine is a step in the right direction and clearly shows the government's commitment towards improving healthcare. The use of the pentavalent vaccine is a natural evolution from the DPT. However, we as vaccine manufacturers need more visibility of government decisions, as it would ensure that we are better prepared to fulfill the requirements,â€? she says. Experts also cite the phenomena of herd immunity having a strong impact in the case for Hib vaccinations, by which immunizing the majority of the population would reduce the disease risk in the unimmunized population. Speaking about the advantages of their pentavalent vaccine COMVAC5, Dr Krishna Ella, CMD, Bharat Biotech, Hyderabad, states, â€œThe pentavalent formulation has several advantages as it halves the number of injections per child and reduces the requirement of cold chain storage space besides easing management of logistics and data. With COMVAC5, Bharat Biotech has achieved a 10 percent market share in the India market and globally, a share of five percent.â€? He adds that Bharat Biotech has devised strategies to further increase its market share to 25 percent in India and 15 percent globally. Cost matters Cost remains one of the most crucial factors that cannot be ignored while introducing an immunization drive for a large country like India. Currently, Global Alliance for Vaccine Initiatives (GAVI) is supplying pentavalent vaccines free-of-cost to India for a period of three years. The vaccine supplied by GAVI is the one manufactured by Serum Institute of India (SII) under the name Pentavac. Ms AurÃ©lia Nguyen, director of policy, GAVI Alliance, outlines the plan GAVI has for India. â€œGAVI will be funding the vaccine in two states, Kerala and Tamil Nadu, throughout 2012, which will be more than 6.2 million doses. The roll-out of the pentavalent vaccine, which began in these two states last December, has reached over 100,000 children so far. India will be expected to share the cost of introduction of the pentavalent in 2012 by funding the procurement of auto-disposable syringes and waste disposal materials in addition to the delivery costs.â€? GAVI is working with the Indian government to explore how it can extend its support and set a program of work customized to India's priorities. The DPT costs the government 2.50 per dose, whereas the pentavalent vaccine was made available by Serum Institute to GAVI at the cost of 100 per dose. The latter's price, though much more than the cost of DPT vaccine, has dropped since the first year of its introduction. It was then purchased at the price of $3 per dose. Ms Nguyen says the latest prices for Pentavac are yet to be published, which as the trends suggest could be lower than those procured earlier. However, the fact remains that in the next few years, the Indian government will gradually have to start footing the bill for pentavalent vaccines. Is it needed? There is also a debate on the need for such a vaccine. Dr Jacob Puliyel, department of paediatrics, St Stephens Hospital, Delhi, points out the concerns of many in the medical community who are questioning the need for this vaccine. â€œThere remains to be a study that can give a scientific justification for the introduction of the Hib vaccine. The NTAGI committee has ignored data that show incidences of pneumonia are less than those projected by UNICEF. The deaths associated with the use of the vaccine in other countries also cannot be denied. There is an urgent need for active surveillance of the effects of the vaccine, which is currently lacking. The combination vaccines should not act as a back door entry for vaccines that we don't actually need,â€? says Dr Puliyel. Not all's well with vaccine makers UNICEF, being the world's largest procurer of vaccines, acquires vaccines from the companies that have been prequalified by the WHO. Since Indian vaccine makers are said to supply over 50 percent of the world's requirements of vaccines, getting the prequalification approval is of utmost importance. In recent times, however, the prequalification approvals of a number of Indian companies have been revoked, due to non-compliance of WHO's regulations. With respect to pentavalent vaccines, one of the first companies to face such a ban was Shantha Biotechnics. In 2010, the WHO, after withdrawing the prequalification approval, ordered the recall and destruction of all stocks of Shan5 on finding the presence of a white sediment on the walls of the vaccine vials. Dr Harish Iyer, CEO, Shantha Biotechnics, says Shantha has since then worked towards making the necessary changes to get prequalification to start producing Shan5 and bring it back to the market. In August 2011, Panacea Biotec, which was among the first companies to launch a pentavalent vaccine EasyFive, faced similar circumstances when their prequalification approval was withdrawn due to inadequate quality assurance processes. The statement by the WHO states EasyFive was not found to be unsafe, but procurement would be stopped until the manufacturer implemented corrective measures. Challenges ahead Kerala and Tamil Nadu have reportedly been chosen as the first states to receive the pentavalent vaccines, keeping in mind their good track record with vaccination coverage. However, pentavalent vaccines were previously introduced in 2008 in various districts of Goa by the state government. While the emphasis on preventable medicine is a positive step by the Government of India, its commitment will be tested in the coming years when it will have to make a concerted effort, like the one made for the polio immunization drive, to ensure successful implementation. To begin with, it means a steady supply of these vaccines through joint efforts of both private and public sectors and high quality vaccines at affordable prices are required. Manasi Vaidya in Bangalore ]]> <![CDATA[Indian biotech's BIRAC opportunity]]> https://biospectrumindia.com/news/95/4152/indian-biotechs-birac-opportunity.html https://biospectrumindia.com/news/95/4152/indian-biotechs-birac-opportunity.html Fri, 13 Jan 2012 14:19:00 +0530 The recent government decision to convert the three-year-old experimental Biotechnology Industry Research Assistance Council (BIRAC) into a â€œnot-for-profitâ€? company under Section 25 of the Indian Companies Act is a significant step to help the nation's fledgling biotechnology industry. The Union Cabinet gave the approval for this important step on November 24, 2011. DBT Secretary Dr M K Bhan and his team deserves full credit for piloting the proposal through the labyrinthine government set-up and convincing the political leadership about the urgent need for such a mechanism to support a vital industry. This has happened at a time when the government is withdrawing gradually from running corporate enterprises and confining itself to regulatory issues as part of the economic liberalization agenda. Given this background, it was not an easy task for the DBT team. It has been learnt that it took a lot of convincing to get the nod for this experimental measure. A lot of tough questions were asked during the Cabinet meeting. The reasonably good work done by BIRAC, set up as a pilot project in 2008, in providing assistance, as part of its mandate, to a good number of innovative projects, would have certainly played some role in getting the cabinet approval. So far, BIRAC has stuck to its goal of underwriting with public funds high risk technologies and processes in biotechnology. BioSpectrum has chronicled many of these projects in the last two years. This is just the beginning of the BIRAC phase of the industry. With the DBT's decision to use 30 percent of its budget allocation only for industry-related projects, funds were not a problem so far. In fact, I have learnt that the industry has been slow in submitting innovative proposals to get BIRAC assistance. Overall, due to paucity of good proposals, the DBT has so far spent only half of the funds allocated for this activity in the last two years. Biotech innovators have certainly a lot of catching up to do. BIRAC team will be busy with legal processes to convert itself into a corporate entity. The corporate entity is set to become operational on April 1, 2012. In the new avatar, BIRAC will be like any other corporate entity and bound by the existing legal framework and governance laws applicable to companies. BIRAC has a year to prove its credentials. Though BIRAC has the freedom to appoint any competent person as chairman and managing director, it is understood that secretary, DBT, and the senior advisor handling the council now will be the chairman and managing director, respectively, for an initial period of 12 months. A review will happen then. BIRAC has also been given the mandate to appoint independent, professional directors who will be compensated as per industry norms. The Cabinet, rightly, did not insist on applicability of existing government pay scales to the BIRAC employees. So, Dr Bhan's team has the onerous task of making full use of the flexibility available to make a real difference in the way a government-run company is set up and run. It is a tough challenge. BIRAC will be required to keep most of the industry leaders and even scientists from research labs and universities out of the corporate set-up to prevent â€œconflict of interestâ€?. After all, as a small industry, every one is connected to everyone else in the biotech ecosystem. If this challenge is overcome by finding the talented people who have an understanding of the industry, the new-look BIRAC will be a game changer for the Indian biotech industry. I wish everyone a Very Happy 2012. Narayanan Suresh Chief Editor sureshn@cybermedia.co.in ]]> <![CDATA[ESC research cannot be ignored]]> https://biospectrumindia.com/news/95/2870/esc-research-cannot-be-ignored.html https://biospectrumindia.com/news/95/2870/esc-research-cannot-be-ignored.html Mon, 09 Jan 2012 17:16:00 +0530 Nandita Singh The author is Editor of BioSpectrum nanditas@cybermedia.co.in India is grappling with setting a clear guideline for the emerging area of stem cell research. Recently, the Indian Council of Medical Research (ICMR) and the Department of Biotechnology (DBT) even organized a public consultation to take the process further. These guidelines were last prepared in 2007 and a number of ethical issues continue to plague, given the nature of research and the high potential of misuse. In fact, research on human subjects itself is in throes of regulation. The Biomedical Research Human Subjects Promotion and Regulation Bill that is in the making, will also address the issue of embryonic stem cell (ESC) research. There is an expectation that discarded embryos from the fertility (IVF) clinics will be directed towards this end, through an acceptable process. The promise of embryonic stem cells is too huge to be ignored. However, California-headquartered Geron Corporation, a pioneer in the embryonic stem cell research recently exited the business to focus on other lucrative projects. What forced the company to take this step was business interest, so to speak. But that does not quite answer many questions, given that this step was taken just a few months after California Institute for Regenerative Medicine gave a loan of $25 million to Geron to support the first human trial of stem cell-based spinal cord therapy. There are not many companies working on embryonic stem cell research that have come close to any therapy. The scientific community was looking up to Geron and the decision led to shock and disappointment, especially for those who are working on the stem cells, embryonic or otherwise. In this background, Geron's exit does speak about the future of embryonic stem cell research, the world over. It is faced not just with ethical and funding challenges but also the limitation of not enough research on the basic science of embryonic stem cells. There are too many gaps in the basic science of embryonic stem cell to move it into therapy yet. It will be a long while for any results to show there. So, all breakthroughs should be celebrated minus the hype. A decade has passed since the embryonic stem cell research kicked up a storm on ethics in 2001 peaking in 2004 when Korea's Hwang Woo-Suk took the global scientific community for a ride, claiming breakthrough that involved cloning human embryo and producing stem cells lines. Government research resources, even in the US, were not supporting embryonic stem cell research until the Obama administration lifted the ban in 2009. Meanwhile, the breakthrough discovery of induced pluripotent stem cells (iPS) from skin happened and that moved the stem cell research into another direction, an uncontroversial one at that. A lot of work is happening on the iPS cells harvested from skin, bone marrow or dental pulp among others. None of that is said to be even in the striking distance of any therapy. But the discoveries are moving ahead the scientific understanding of stem cells, which will be the foundation of therapies to come. Stem cell therapy is an emerging area. In due course, it will live up to its promise. Given the background, a clear policy direction will help Indian researchers get closer to regenerative therapies, in line with countries like Australia, a forerunner in the segment. Meanwhile, cord blood ands stem cell banking is a thriving business proposition in India. ]]> <![CDATA[Gilead Sciences, WHO join hands to tackle kala azar]]> https://biospectrumindia.com/news/95/1778/gilead-sciences-who-join-hands-to-tackle-kala-azar.html https://biospectrumindia.com/news/95/1778/gilead-sciences-who-join-hands-to-tackle-kala-azar.html Mon, 09 Jan 2012 17:14:00 +0530 Gilead Sciences, a biopharmaceutical company headquartered in Foster City, California, will donate 445,000 vials of AmBisome (amphotericin B liposome for injection) to help the World Health Organization (WHO) treat more than 50,000 patients with visceral leishmaniasis (VL), also known as kala azar. Under its five-year initiative with the WHO, the donation of $8 million by Gilead Sciences for VL treatment, 'AmBisome' is expected to reach 50,000 people in resource-limited countries, including India. Visceral leishmaniasis is widespread in South Asia and the Horn of Africa, where it affects hundreds of thousands of people annually. Without treatment, the mortality rate is close to 100 percent. In the Indian subcontinent, where VL is endemic, the WHO Leishmaniasis Expert Committee recommends single-dose AmBisome as the safest and most-effective treatment for the disease. AmBisome is approved for treatment of VL in the US as well. Advinus completes study on GK-activator Advinus Therapeutics, promoted by the TATA Group, has successfully completed a 14-day proof-of-concept (POC) study on 60 type 2 diabetic patients for its lead molecule, GKM-001, a glucokinase activator. The results of the trial show effective glucose lowering across all doses tested without any incidence of hypoglycemia or any other clinically relevant adverse events. The clinical trials on GKM-001 validate the company's pre-clinical hypothesis that a liver selective glucokinase activator would not cause hypoglycemia (very low blood sugar), while showing robust efficacy. â€œGKM-001 is differentiated from most other GK molecules that are in development, or have been discontinued, due to its novel liver selective mechanism of action. GKM-001 has a prolonged pharmacological effect and a half-life that should support a once-a-day dosing as both mono and combination therapy,â€? said Dr Rashmi Barbhaiya, MD & CEO, Advinus Therapeutics. He added that Advinus is actively exploring partnership options to expedite further development and global marketing of GKM-001. inStem signs MoU with CIRM The Institute for Stem Cell Biology and Regenerative Medicine (inStem), an autonomous research institute funded by the Department of Biotechnology, recently signed a memorandum of understanding (MoU) with the California Institute for Regenerative Medicine (CIRM) for supporting collaborative research projects between outstanding stem cell scientists in India and California. Under this request for applications, inStem plans to commit up to 5.225 crore ($1 million) per annum to support up to five collaborative projects involving Indian teams, approved for award by the CIRM. The CIRM intends to commit up to $35 million to support up to 25 awards. Projects will be funded for up to three years, with justifiable direct project costs of up to 15.75 lakh ($300,000) per year (California component). Under the terms of the agreement, the CIRM and inStem have announced the CIRM Basic Biology IV Awards. The objective is to foster cutting-edge research tackling significant and unresolved issues in human stem cell biology. Studies should focus on elucidating basic molecular and cellular mechanisms and should utilize pluripotent stem cells, adult stem cells, and/or their differentiated derivatives. ICAR celebrates Indo-US partnership To mark the 60 years of fruitful Indo-US collaboration in agricultural research, the Indian Council for Agricultural Research (ICAR) organized an event at the Indian Agricultural Research Institute (IARI), New Delhi campus, on December 20. The theme, 'Agricultural Research and Innovation', highlighted the importance of the establishment of South Asian Universities in rapid adoptions of Green Revolution technologies developed by the IARI in collaboration with the Consultative Group on International Agricultural Research Institutions. The speakers noted that the area under wheat nearly doubled and the production tripled within the first decade of the Green Revolution due to the collaborative work. Dr Rajiv Shah, the administrator of the USAID, Dr MS Swaminathan, member of Parliament and chairman of MS Swaminathan Foundation, Dr S Ayyappan, secretary, DARE, and DG, ICAR, and Dr H S Gupta, director, IARI, were the speakers. â€œSince that first partnership over half a century ago, the relationship between our two nations has transformed dramatically, delivering meaningful results,â€? said Dr Rajiv Shah. ]]> <![CDATA[Generic version of Caduet launched in the US]]> https://biospectrumindia.com/news/95/2349/generic-version-of-caduet-launched-in-the-us.html https://biospectrumindia.com/news/95/2349/generic-version-of-caduet-launched-in-the-us.html Mon, 09 Jan 2012 17:12:00 +0530 Ranbaxy Pharmaceuticals launched an authorized generic version of Caduet in the US market, as part of an agreement with Pfizer. Caduet is a fixed-dose combination of Atorvastatin-Amlodipine besylate (presently marketed by Pfizer under the brand Caduet, which also contains a crystalline form of Atorvastatin). The product is indicated for patients suffering from both, high blood pressure and high levels of cholesterol. Caduet generated total annual sales of $339 million in the US. Ranbaxy is making available the full range of the generic version of Caduet. Mr Venkat Krishnan, senior vice president and regional director, Americas, Ranbaxy, said, â€œThe introduction of Atorvastatin-Amlodipine besylate tablets is a significant and important addition to our portfolio of cardio-vascular products, in the US.â€? FDA nod for generic Cymbalta capsules Lupin Pharmaceuticals received tentative approval for its Duloxetine Hydrochloride Delayed-release (HCl DR) capsules (20mg, 30mg and 60mg) from the US Food and Drugs Administration for the company's abbreviated new drug application to market a generic version of Eli Lily's Cymbalta Delayed-release capsules. Lupin's Duloxetine HCl DR capsules are the AB-rated generic equivalent of Eli Lily's Cymbalta Delayed-release capsules of 20mg, 30mg and 60mg strengths. Duloxetine HCl DR capsule is indicated for treatment of major depressive disorder, generalized anxiety disorder, management of neuropathic pain associated with diabetic peripheral neuropathy, management of fibromyalgia and management of chronic musculoskeletal pain. Cymbalta HCl DR capsules had annual US sales of approximately $3.5 billion for the twelve months ending September 2011. AMDL's cardiac care equipment in India The healthcare division of Advanced Micronic Devices, AMDL Health, a leading provider of medical equipment and devices, launched Cardiac Science family of advanced cardiac diagnostic products in India. The products were showcased at the 63rd Annual Conference CSI, Mumbai, held in December. This marks AMDL Health's foray in to the cardiovascular market in India. The products to be sold are under the brands of Cardiac Science, Quinton, Burdick, and Powerheart. â€œIndia is the second largest potential cardiovascular market in the world and is expected to reach $589 million by 2017,â€? said Mr Arindam Sen, chief executive officer, AMDL. â€œWe are committed to make technologically advanced devices accessible to the Indian healthcare market.â€? AMDL Health plans to target tier 1 and tier 2 cities that are changing the landscape of the Indian medical equipment industry. Generic versions of Lipitor in market As the patent on Lipitor, Pfizer's premier drug for lowering cholesterol expired on November 30, Ranbaxy and Watson Pharma entered the race to offer generic versions of Atorvastatin (Lipitor). Ranbaxy Pharmaceuticals, a wholly-owned subsidiary of Ranbaxy Laboratories, received final approval from the US Food and Drug Administration to manufacture and market Atorvastatin and has launched the product in the US market. Watson Pharmaceuticals too confirmed that it has launched an authorized generic version of Lipitor (atorvastatin calcium tablets) as part of an exclusive agreement with Pfizer. Watson began shipping the product on November 30. Under the terms of the exclusive supply and distribution agreement, Pfizer manufactures and supplies Watson with all dosage strengths of the authorized generic product. Watson markets and distributes the product in the US. Pfizer will receive a share of the net sales from Watson's sales of the product. The agreement runs until November 30, 2016. Other terms of the agreement have not been disclosed. Lipitor is indicated as an adjunct to diet to reduce elevated total cholesterol, LDL, triglycerides and to increase HDL cholesterol. Sources say that the drug constituted one fifth of Pfizer's revenues with the most recent data, indicating that, Lipitor helped Pfizer earn approximately $7.8 billion in the last twelve months. ]]> <![CDATA[Biomedical research on track in India]]> https://biospectrumindia.com/news/95/1171/biomedical-research-on-track-in-india.html https://biospectrumindia.com/news/95/1171/biomedical-research-on-track-in-india.html Mon, 09 Jan 2012 17:11:00 +0530 On a strategic tour of India to improve collaborations between research institutes in India and the National Institute of Health (NIH), US, Dr Francis Collins, director, NIH, spoke about the impact NIH funding has had on research in India and how it intends to expand its presence in India. He said, â€œCurrently there are around 260 projects operating on active research grants from NIH, in India. This is an exciting time in biomedical research where we are able to make use of the deluge of research findings in the molecular basis of any disease. Speaking about the impact of induced pluripotent stem cells on biomedical research he said, â€œIn the last six years, major advances have been made in stem cell research using iPS. Over 20 disease models have been created using iPS which will aid to further research on small molecules for the treatment of diseases ranging from Parkinsons to schizophrenia.â€? Karnataka to have a nanotech park Karnataka recently proposed to establish a state-of-the-art nano park near Bangalore International Airport. The proposed park will have a nano incubation center, science and technology-based business incubator to incubate early stage entrepreneurial ventures, infrastructure and support systems that are necessary for business incubation centers, nanotechnology industrial cluster with world class facilities, centers of excellence for nanotech professional education to develop domain expertise. Another important step taken by the Karnataka Government is that it provided about an acre of land for setting up of a â€œNano Labâ€? by the Jawaharlal Nehru Center for Advanced Scientific Research in the neighboring premises of Mahatma Gandhi Institute of Rural Energy and Development at Jakkur. The institute is being established with funding from Government of India under the Nano Mission at an estimated cost of 1,000 million, for which the Government of Karnataka has already allocated 14 acres on Tumkur Road for this institute. Genotypic certified by Ion Torrent Genotypic Technology has become the first certified service provider for Ion Torrent's PGM in India. Under Ion Torrent's new service provider program, CSP certification means that the organization has been trained and tested by Ion Torrent to produce high quality sequence data. Work done at Genotypic is acknowledged and cited in over 200 publications. Their 11,000 square feet genomics facility comprising microarray, next generation sequencing and bioinformatics facilities are located in Bangalore, India. Genotypic is an ISO 9001:2008 accredited company and its business processes run on a cloud-based enterprise resource and planning (ERP) by SAP. Genotypic is also an Agilent-certified microarray service provider, the first in India. Set up in 1998, it commenced business operations in 2000. It has over 500 clients in India and as many worldwide. The Ion Torrent platform is a fast, simple, scalable and cost-effective next generation DNA sequencing platform, which harnesses the power of semi-conductor technology for converting DNA sequence information into digital output. Distance between people, science still wide, says Dr Bhan Dr M K Bhan, secretary, Department of Biotechnology, Government of India, while addressing the delegates at the 5th annual Indian MedTech summit (held from December 5-6, 2011 at New Delhi), stressed on the increased role of medical technologies to bridge the existing gap and making healthcare accessible to poor and needy. Dr Bhan said, â€œThe model of healthcare in India currently is unsustainable. The distance between the science and people is much wider. I feel that the foundation must be right and the healthcare must be based on the basic requirements of people. Therefore, healthcare has to be made affordable and accessible with the help of technology. The summit started with the opening remarks from Prof Balram Bhargava, executive director, India, Stanford-India Biodesign. The chief guest was Prof R C Deka, director, AIIMS, New Delhi. Dr Francis Collins, director, National Institute of Health, US, spoke on harnessing technology for global health solutions. Among the other speakers in the inaugural session, was Dr Robert Pettigrew, director, National Institute of Biomedical Imaging and Bioengineering, NIH, USA. The other sessions had the participation of Dr Paul Yock, director, Stanford Design; Dr Rajiv Doshi, executive director, US, Stanford-India Biodesign; and lot many prominent researchers and company heads. During the 2nd day of the summit, a US-India Grand Challenge on advances in healthcare through affordable technologies was also held. Govt, CRAMS industry to resolve issues At a Contract Research and Manufacturing Services (CRAMS) conference, organized by the Confederation of Indian Industry (CII), New Delhi, representatives from both government and industry agreed to form a joint committee to mitigate the issues. The one day conference offered a great platform for industry and government representatives to deliberate on bottlenecks and chalk out future strategies. The conference had three sessions on overview of CRAMS in India, contract research opportunities and regulatory and policy interventions, respectively. The conference saw the participation of representatives of various companies and prominent persons from the government and the CRAMS industry. Govt to double pharma exports by 2014 To tackle the intense competition from various countries such as China and Brazil, the Indian government plans to put in place strategies to increase pharma exports in a major way. According to Mr Jyotiraditya M Scindia, Minister of State for Commerce and Industry, Government of India, â€œGovernment has already prepared strategies to double the pharma exports to $25 billion by 2013-14, including increase in the share of India's pharma exports to China. The minister while speaking in Parliament, revealed that Indian pharmaceutical exporters are facing intense competition in international markets from China, particularly in the bulk drugs sector. He added that the competition in formulations is also increasing gradually from China and Brazilian companies in Latin American countries. As per UN COMTRADE data, in the year 2010, the Indian exports in bulk drugs stood at 5,402 crore ($1034.04 million) whereas formulations, were 31,835 crore ($6093.22 million). In comparison to this, China's figures were 31,559 crore ($6040.26 million) in bulk exports and 23,308 crore ($4461.17 million) in formulations. At the same time, Brazil had 429.86 crore ($82.27 million) worth bulk exports and 6,635 crore ($1270.40 million) in case of formulations. Eppendorf center gets ISO accreditation Eppendorf India's Pipette Calibration Center in Chennai, has received ISO 17025:2005 accreditation from the National Accreditation Board for Testing and Calibration Laboratories (NABL). The center can now calibrate any make of piston stroke pipette and issue certificate as per the guidelines of the NABL. This certification of ISO/IEC 17025:2005 is given under the category 'mechanical (volume)' based on the methods recommended in ISO 8655. Eppendorf India's receipt of this accreditation from NABL is the first-of-its-kind in the industry for piston stroke pipette. Customers across the country can now calibrate their micro pipettes (fixed, adjustable-volume, mechanical and electronic) and dispensers at the state-of-the-art facility. Bangalore to have a biopharma park Ozonegroup, a leading property developer from Bangalore, launched 'Jeevitham', a state-of-the-art pharma and biotech industrial cluster being developed on a sprawling 330 acres in Chikaballapur, North Bangalore. The project, christened as â€œJeevithamâ€? meaning â€œcaring for lifeâ€?, is being developed with the patronage of Karnataka Pharmaceutical Association. The cost of the project is estimated to be 2,000 crore and Ozonegroup plans to invest about 500 crore in the project. The companies to be housed in the park will invest the rest of the money. The park would also house allied industries like printing and packaging industry, analytical labs and R&D facilities. Jeevitham offers pharma companies an enabling environment with world-class facilities at their door step like water, power, effluent treatment, sewage treatment, waste water recycling and reuse, solid waste management, 24X7 security services and wide tree lined roads for easy movement of container traffic in the midst of a pollen-free environment. Jeevitham cluster is also integrated with amenities like ready-to-use 3,00,000 sq ft warehousing facilities, truck terminal, weigh bridges, business center, hotel, amphitheatre, central park, residential quarters with club house and gym, convenience shopping, bank and C&F offices. Jeevitham would be developed in two phases. Phase 1, of about 275 acres, will be ready for operations by the end of 2013. However, allotment to the industries shall begin by the third quarter of 2012. Genaxy introduces magnetic bead purification kits Genaxy Scientific has introduced new magnetic bead kits, 'The AxyPrep Mag', from Axygen Biosciences, a division of Axygen, US, in the India market. Axygen Magnetic beads are approximately of one micro meter in size with magnetite coating. These cores are encapsulated by non-styrene polymer surface. Also called 'The Mighty Beads' because of its size, the yield is said to automatically remain consistent. The product utilizes a unique paramagnetic bead-based chemistry for the purification and clean-up of nucleic acids compatible with a variety of genomics downstream applications such as DNA sequencing, genotyping and gene expression. The range includes AxyPrep Mag DyeClean, AxyPrep Mag PCR Normalizer Kit, AxyPrep Mag, FragmentSelect Kits and AxyPrep Mag PCR Clean-up. Thermo Fisher introduces centrifuge for blood banking Thermo Fisher Scientific has introduced centrifuge for large-volume blood banking and bioprocessing. Thermo Scientific Sorvall RC 12BP plus centrifuge is a large-capacity, high-throughput floor standing centrifuge for blood banking and bioprocessing applications. With a maximum capacity of 12 L, the centrifuge can process up to 12 blood bag systems (up to 500 mL) or six 2,000 mL Thermo Scientific Nalgene bio-bottles. Run-to-run reproducibility is ensured by the accumulated centrifugal effect function, which automatically compensates for any variations in acceleration due to full or partial rotor loading. Precise control of acceleration and deceleration rates ensures that sample integrity is retained even during delicate low-speed pelleting applications. Monsanto awaits NBA nod for onion Monsanto, Mumbai, applied to the National Biodiversity Authority (NBA) to use two varieties of Indian onions for potential hybridization and is now awaiting clearance from the authority. Monsanto submitted an application on June 28, 2011, in formâ€“I for access to two pairs of CMS lines MS 48 and MS 65, male sterile lines and fertile maintainer lines of onions (25g each), developed by the Indian Institute of Horticulture Research, ICAR, Bangalore. Speaking on the issue in Parliament, Minister of State for Environment and Forests, Ms Jayanthi Natarajan, said, â€œThe relevance of GEAC does not arise in this case, since the applicant is not seeking permission from the National Biodiversity Authority for large-scale field trials and commercialization.â€? WHO approval for Mylan drug Mylan Laboratories has received approval for three antiretroviral (ARV) therapies used to treat HIV/AIDS under the World Health Organization's requalification of Medicines Programme. These products include Atazanavir capsule, Ritonavir tablet and Tenofovir Disoproxil Fumarate and Lamivudine tablet, which is a co-packaged product, for a once-daily treatment for patients who have developed resistance to standard first-line ARVs or â€œsecond-line-in-a-boxâ€?. Approximately one-third of HIV/AIDS patients in developing countries depend on a Mylan ARV product. Stemade launches stem cell banking Stemade Biotech, India's first player in dental stem cell banking, launched its operations in Chandigarh after its successful launch in New Delhi, Mumbai, Pune, Hyderabad, Chennai and Bangalore. Founder and managing director Mr Shailesh Gadre said, â€œThe cord blood banking market, where the opportunity is available only at birth, is currently poised at a range of 80,000 to 100,000. However, with dental stem cell, the market is positioned five times more than that. Therefore, we are quite optimistic about reaching one lakh registration by 2013â€?. Tussle over Crofelemer Glenmark had entered into a strategic partnership with California-based Napo pharmaceuticals during July 2005. This enabled Glenmark to get exclusive license to develop and commercialize Crofelemer for India and several other markets. Recently, Napo terminated the agreement on grounds of failure to commercialize Crofelemer. Glenmark had exclusive rights to develop, register and commercialize Crofelemer in over 140 countries, including Japan and China. Glenmark in a statement issued on December 13 said Napo had no right to terminate the collaboration agreement and that it was seeking a declaration from an arbitration panel that Napo's claims were unfounded. Transgene to sell tech for $5 mn Transgene Biotek sold the technology for recombinant human erythropoietin (rh-EPO) to TSS EXPORT GmbH FZE, one of the group companies of the TSS Group for 26.12 crore ($5 million). The technology transfer and sale is expected to be completed during a period of approximately five to six months. Speaking about the transaction, Dr K K Rao, MD, Transgene Biotek said, â€œThis transaction fulfills the pledge we made earlier this year to focus on revenue generation whilst monetizing the sale of underutilized bio-generic drug assets.â€? Bt brinjal heads to Bangladesh It is likely that the variety of Bt brinjal developed in India by Mahyco along with research institutes like UAS, Dharwad and Tamil Nadu Agricultural University, Combatore, will be released in neighbouring countries, such as Bangladesh and Phillipines, before India. Dr Usha Barwale Zehr, chief technology officer, Mahyco, hinted at this recently. Mahyco's technology has been licensed to these countries and is currently in advanced stages of field trials. In February 2010 , the then environment minister, Mr Jairam Ramesh, announced that after deliberations with the Genetic Engineering Approval Committee (GEAC) a moratorium be imposed on the release of Bt brinjal in India. ]]> <![CDATA[Clinigene, Pacific Biomarkers enter deal]]> https://biospectrumindia.com/news/95/5700/clinigene-pacific-biomarkers-enter-deal.html https://biospectrumindia.com/news/95/5700/clinigene-pacific-biomarkers-enter-deal.html Mon, 09 Jan 2012 17:08:00 +0530 Clinigene International, a subsidiary of Biocon and Pacific Biomarkers, a US-based limited liability company, entered into a collaborative agreement to address the specialty biomarker and high-end clinical trial laboratory needs of the global pharmaceutical and biotechnology industry. Mr Ronald Helm, CEO of Pacific Biomarkers said this partnership with Clinigene provided them access to India, considered to be an emerging hub for drug development and contract research. He further added, â€œClinigene's state-of-the-art facilities and highly qualified staff help us offer to all of our clients an economic option to conduct their biomarker and specialty clinical lab tests. We are also excited about Clinigene' s unique capabilities in cell-based assays and immunoanalytical testing services, which are of great interest to the global pharmaceutical and biotechnology community.â€? â€œThe PBI is a recognized global leader in providing specialty biomarkers and clinical diagnostic assay services to discovery and development-based life science enterprises. We are delighted that the PBI has selected Clinigene as its partner in India and we look forward to supporting it in extending and expanding its specialist service offerings,'' said Mr Peter Bains, director of research services business, Clinigene. Israeli firm to hold trial for schizophrenia Indian regulatory authorities and Indian local ethics committees have given their approval to BiolineRX, an Israel-based company to commence the clinical trial of BL-1020, a first-in-class molecule, orally available GABA-enhanced anti-psychotic for the treatment of schizophrenia. The Israeli drug company said that it will soon commence clinical trial for the treatment of schizophrenia in India. BiolineRX said initiation visits at the Indian clinical research centers will be completed this month and the first patient is likely to be enrolled by December. The trial is expected to be conducted at 18 sites in India. The goal of the study is to determine the short and long-term cognitive efficacy as well as anti-psychotic efficacy, safety and tolerability of BL-1020 in schizophrenic patients over periods of six, 12 and 24 weeks. Quintiles launches CRO in China Quintiles has launched Kun Tuo (koon-TOO-ah), a local contract research organization (CRO), built to service the unique needs of the Chinese biopharmaceutical industry and multinational biopharma companies operating in China. Building on Quintiles' unmatched success at the global level and experience in conducting clinical trials in China since 1997, Kun Tuo will focus on developing customized solutions to help local and global biopharma companies achieve successful registration of new medicines in China. Kun Tuo will provide a full range of services, including comprehensive clinical trial management, regulatory submission preparation, biostatistics and data management. Kun Tuo will tap Quintiles' global resources and expertise to develop customized offerings in key therapeutic areas, along with vaccines, late phase studies, medical devices and diagnostics. GVK, Temple Varsity collaborate GVK Biosciences entered into a drug discovery alliance with the Moulder Center for Drug Discovery Research at Temple University. GVK will be responsible for target validation, lead identification and lead optimization of small molecules in selected therapeutic areas, including cardiovascular, metabolic, and central nervous system disorders. The Moulder Center is a unique, fully integrated state-of-the-art drug discovery center that is used for both internal research within Temple University and for external collaborations with pharmaceutical and biotech companies and other universities. GVK will apply their integrated drug discovery expertise and technologies to identify interesting small molecules against selected targets. Human trials for HIV vaccine In the first clinical trial of an injectable vaccine containing trimeric HIV envelope protein (gp140) relevant to the predominant strain of HIV in Africa, researchers from four UK academic centers and from the Infectious Disease Research Institute (IDRI) have come together to evaluate whether the vaccine is safe for use in human volunteers. The trial, which is funded by the Wellcome Trust and goes by the name MUCOVAC2, is evaluating a vaccine that contains the HIV trimeric gp140 protein CN54, representative of Clade C strains of the virus. The vaccine candidate will be formulated with an adjuvant known as GLA, developed by IDRI to enhance immune responsiveness following intramuscular injection. ]]> <![CDATA[BioSpectrum awards excellence]]> https://biospectrumindia.com/news/95/3200/biospectrum-awards-excellence.html https://biospectrumindia.com/news/95/3200/biospectrum-awards-excellence.html Mon, 09 Jan 2012 17:02:00 +0530 The BioSpectrum Awards 2011 nite, held in Bangalore, witnessed the celebration of excellence in the young and dynamic biotech industry The winners of the BioSpectrum Awards 2011 (L to R): Dr Swaminathan Sethuraman, director of SASTRA's Nanotechnology and Advanced Materials Center, Thanjavur; Ms Sudha Kanago, head of global resourcing practice & Mr Hemant Rehani, head of clinical practice, Quintiles India; Mr G S Krishnan, regional president, Novozymes South Asia; Mr Akash Puranik, VP-marketing, Biocon; Dr Rajesh Jain, joint MD, Panacea Biotec, New Delhi; Mr S Thyagarajan, chairman, Spinco, Chennai; Dr Lalji Singh, VC, Banaras Hindu University; Dr G D Yadav, VC, ICT, Mumbai;Prof Virander S Chauhan, director, ICGEB; Mr Supreet Deshpande, CEO & founder, VLife Sciences, Pune; Dr Chetan E Chitnis, principal leader- malaria group, ICGEB; Dr D C Jain, GM, IPCA Labs; Dr P Sateesh Kumar, director-research, Nuziveedu Seeds; Dr M Z Abdin, dean of the faculty of sciences, Hamdard University; Mr Govind Rao, VP - BioIT, Ocimum BioSolutions The 9th edition of the annual BioSpectrum Awards nite recognized and honored individuals and groups who have excelled and achieved honors in their fields of endeavor in the biotech industry. The event that took place at the plush Sheraton Hotel at Brigade Gateway in Bangalore on December 16, 2011, was made memorable with the presence of about 200 eminent researchers and industry leaders from the biotech space. Speaking on the occasion, Mr Abraham Mathew, chief editor of BioSpectrum, lauded the changing face of the biotech industry and elaborated on the selection process involved in choosing the nominees for the BioSpectrum Awards. A panel discussion, moderated by Mr N Suresh, group editor, BioSpectrum, on 'Why should society support biotech' set the ball rolling for an evening of celebrations of an industry striving towards greater achievements in India. Prof P K Khosla, vice chancellor of Shoolini University in Solan, Himachal Pradesh, shared interesting insights from the academic world and stressed on the need for more academia-industry partnerships. â€œThe ranking system for educational universities worldwide is an important indicator of the quality of education imparted. The criteria for such rankings is that 30 percent of weightage is given to industry-academia relations. Industries should come forward to collaborate with universities,â€? he urged. Based on the annual survey of India's biotech industry, conducted by BioSpectrum along with the Association of Biotechnology Led Enterprises (ABLE) in May and June, and another survey to rank the biotech teaching instituitions in India, conducted by BioSpectrum, the number one companies and institutions in different categories were honored. Receiving the Best BioPharma Company Award, Mr Akash Puranik, vice president - marketing, Biocon, said, â€œWe have just received three global deals and this award, after the deals, is like the icing on the cake.â€? Spinco Chairman Mr S Thyagarajan, who received the Best Technology Provider of the Year Award from Dr Sathish Ravetkar, senior director, Serum Instituite of India, Pune, dedicated it to fellow 'Spincoites' and said, â€œThis is a very happy occasion as we have been waiting for years to be ranked one.â€? Spinco Chairman Mr S Thyagarajan receives the Best Technology Provider of the Year Award from Dr Sathish Ravetkar, senior director, Serum Institute of India, Pune Mr G S Krishnan, regional president, Novozymes South Asia, receives the BioIndustrial Company of the Year Award from Dr Shenoy, director, Padmashree Group of Educational Instituitions Mr Akash Puranik, VP - marketing, Biocon, receives the Best BioPharma Company of the Year Award from Mr Ramesh Raju, executive director, Oxford Group of Institutions Mr Govind Rao, VP, BioIT, Ocimum Biosolutions, receives the BioInformatics Company of the Year Award from Dr S D Ravetkar, senior director, Serum Institute of India, Pune Dr P Sateesh Kumar, director â€“ Research, Nuziveedu Seeds, receives the BioAgriculture Company of the Year Award from Prof P K Khosla, VC, Shoolini University, Himachal Pradesh Mr Hemant Rehani, head, clinical practice, & Ms Sudha Kanago, head, global functioning resourcing practice, Quintiles India, jointly receive the BioServices Company of the Year Award from Mr N Suresh, group editor, BioSpectrum Dr Lalji Singh, VC, BHU, hands over the Best Public Biotech School Award to Dr G D Yadav, VC, ICT, Mumbai Dr Swaminathan Sethuraman, director of SASTRA's Nanotechnology and Advanced Materials Center, Thanjavur receives the Best Private Biotech School Award from Dr Lalji Singh, VC, BHU Dr M Z Abdin, dean, faculty of sciences, Hamdard University, and Dr D C Jain, GM, IPCA Labs, receive a special category award for Public Private Partnership Excellence from Ms Deepanwita Chattopadhyay, CEO of IKP Knowledge Park Dr Lalji Singh, VC, BHU, receives the BioSpectrum Lifetime Achievement Award from Mr Pradeep Gupta, chairman of CyberMedia and publisher of BioSpectrum Prof Virander S Chauhan, director, ICGEB, (left) presents the BioSpectrum Entrepreneur of the Year Award to Mr Supreet Deshpande, CEO & founder, VLife Sciences Prof Virander S Chauhan, director, ICGEB and Dr Chetan E Chitnis, principal leader- malaria group, ICGEB, receive the BioSpectrum Person of the Year Awards from Mr Hans Guenter Looeffer, deputy consul general of the Federal Republic of Germany in Bangalore Dr Rajesh Jain, joint MD, Panacea Biotec, along with his wife and team, receives the BioSpectrum Product of the Year for PacliALL from Mr Abraham Mathew, chief editor, BioSpectrum Mr G S Krishnan, regional president, Novozymes South Asia, received the BioIndustrial Company of the Year Award from Dr Rajesh Shenoy, director of Padmashree Group of Educational Instituitions. For Quintiles India, which won the BioServices Company of the Year Award, Mr Hemant Rehani, head of clinical practice, and Ms Sudha Kanago, head of global functioning resourcing practice, jointly received the award. It was given away by Mr N Suresh, group editor, BioSpectrum. Mr Govind Rao, vice president, BioIT, Ocimum Biosolutions, received the BioInformatics Company of the Year Award from Dr S D Ravetkar, senior director, Serum Institute of India, Pune. Dr P Sateesh Kumar, director â€“ Research, Nuziveedu Seeds, received the BioAgriculture Company of the Year Award 2011 from Prof P K Khosla, vice-chancellor of Shoolini University in Solan, Himachal Pradesh. Dr Lalji Singh, vice chancellor, Banaras Hindu University (BHU), gave away the award for the Best Public Biotech School and the Best Private Biotech School to Dr G D Yadav, vice chancellor of Institute of Chemical Technology, and Dr Swaminathan Sethuraman, director of SASTRA's Nanotechnology and Advanced Materials Center, respectively. Speaking on the importance of a strong pipeline of entrepreneurs, Mr Pradeep Gupta, chairman of CyberMedia and publisher of BioSpectrum and one of the founding members of the Indian Angel Network, which helps budding entrepreneurs, said, â€œThere is less investment in the biotech industry. The need of the hour is mentoring of start-ups in the industry.â€? He also rued that there were very few special interest groups in biotech. Dr Ravi Dhar, senior consultant of Biotechnology Industry Research Assistance Council (BIRAP), shared the council's future plans to put biotech industry on a sustainable growth path. BIRAP is a program initiated by the Department of Biotechnology, in partnership with ABLE and Biotech Consortium India Limited, with an objective to assist and promote emerging biotech entrepreneurs and facilitate innovative R&D in existing small, medium as well as large industries, which has got government's approval to be converted into a corporate entity. Ms Deepanwita Chattopadhyay, CEO and managing director, IKP Knowledge Park, and a member of the 10-member jury comittee that selected this year's awardees shared the details of the awards selection process with the audience. A special category award created for the first time for public private partnership excellence in the biotech field was jointly received by Dr M Z Abdin, dean of the faculty of sciences, Hamdard University, and Dr D C Jain, GM, IPCA Labs. Dr Rajesh Jain, joint MD, Panacea Biotec, accepting the Product Of The Year Award for PacliALL, a breast cancer drug, called it â€œthe first example of affordable innovative product in Indiaâ€?. Mr Supreet Deshpande, CEO, VLife Sciences, the recipient of the Entrepreneur of the Year Award termed the award to be like â€œa booster dose to help do much moreâ€?. Appreciating his team's efforts, he said, â€œA captain can only be as good as the teamâ€?. Dr Virander Chauhan, director, International Center for Genetic Engineering and Biotechnology (ICGEB), shared a light moment with the audience by comparing himself and Dr Chetan Chitnis, principal investigator-Malaria Research Group, ICGEB, with the yesteryear cricketer Chetan Chauhan who inspite of taking all the battering from the Australian bowlers went unrecognized. Both Dr Chitnis and Dr Chauhan received the Person Of The Year Award from Mr Hans Guenter Loeffler, deputy consul general of the Federal Republic of Germany in Bangalore. Throwing light on the status of the malaria vaccine, Dr Chitnis said, â€œThe phase I trial is done. We will make this vaccine a reality.â€? The crowning moment of the evening was the presentation of the Lifetime Achievement Award to the father of DNA fingerprinting in India, Dr Lalji Singh, vice-chancellor of Banaras Hindu University. Receiving the award from Mr Pradeep Gupta, he said, â€œThis is the first time that I am receiving an award for the work which, till now, has only brought me summons or arrest warrants.â€? He narrated some amusing anecdotes about the appearances he had to make in courts in various parts of the country to present evidence based on DNA fingerprinting techniques. His book, My Travails In The Witness Box, will be released soon. Ms Nandita Singh, editor, BioSpectrum, delivered the closing remarks to the ceremony which saw key persons representing a broad spectrum of the life sciences industry coming together to applaud and appreciate excellence. Uma Kelath in Bangalore Why should society support biotech? Mr N Suresh, group editor, BioSpectrum, kick-started the discussion with a comment on how negative publicity has affected the industry. â€œOf late biotechnology is in the news only for the wrong reasons. The public gets to hear only about Bt brinjal-related controversies and illegal clinical research organizations. There is a need to create a brand BT in order for it to truly reach the masses,â€? he said. Dr S D Ravetkar, senior director, Serum Institute of India, called for emulating the principles of the IT industry. â€œWe should follow the IT industry by taking biotechnology to the schools, the way computers have become an integral part of schools. We need to ensure that children understand how much impact biotechnology has already made in our lives and how it continues to do so,â€? he commented. Dr Vijay Chandru, president, ABLE, and CEO, Strand Life Sciences, said, â€œHitherto, there has been no technology in history such as biotechnology that has had the potential to address issues ranging from food security to medicine. In order to help the public realise the importance of biotech, research should be directed towards a particular goal, which is deliverable to the public. We need to be involved in research from which we can derive value.â€? Dr Rajesh Jain, joint MD, Panacea Biotec, emphasized the need for intelligent marketing of biotechnology. â€œLife-saving vaccines are among the greatest contributions of the biotechnology industry. The public is aware of such contributions, but biotechnology has taken a beating in the last few years due to controversies. To counter this, we need a marketing strategy, which is both aggressive and creative, to help people understand biotechnology,â€? he pointed out. Dr B V Ravi Kumar, MD, XCyton Diagnostics, had an interesting view on making the public more aware of biotechnology. â€œMost of healthcare in biotechnology is perceived to be a part of the pharmaceutical industry. Similarly, a lot of agricultural biotech is considered to be a part of agricultural sciences. The need of the hour is a sustained campaign to educate the masses about what biotechnology is all about,â€? he said. Dr G D Yadav, vice-chancellor, Institute of Chemical Technology, emphasized the need to include principles of biology in engineering courses for people to grasp its underlying concepts. Echoing these sentiments, other academicians also spoke of the need to improve the industry-academia relations to produce a comprehensive work force for the biotechnology industry. Presenting an entrepreneur's view, Mr Pradeep Gupta, chairman and managing director of CyberMedia group and promoter of BioSpectrum, said, â€œThere is a need to bring the business of biotechnology closer to the consumer. We need to think in an oblique manner and try to present it in a format, which can appeal to the public.â€? Dr K K Narayanan, MD, Metahelix, said biotechnology has touched the lives of millions of farmers through Bt cotton. He aptly summed up the discussion when he said, â€œBiotechnology is a multi-faceted field, because of which there is a strong need for people to unite across the different sectors. Industries across verticals of pharma, agriculture and bioinformatics should present a united front in the times of crisis. These actions will go a long way in presenting to the public a positive outlook for biotechnology.â€? . Manasi Vaidya in Bangalore ]]> <![CDATA[Constant dialogue key to collaborations]]> https://biospectrumindia.com/news/95/2622/constant-dialogue-key-to-collaborations.html https://biospectrumindia.com/news/95/2622/constant-dialogue-key-to-collaborations.html Mon, 09 Jan 2012 16:57:00 +0530 A CEO conclave provides a platform to German trade officials and Indian biotech and pharma companies to interact and understand the nuances of expanding business in Deutschland The life sciences industry in both India and Germany has made significant contribution to the gross domestic product and in creating a number of job opportunities. Nevertheless, fierce competition and a difficult market environment are constant challenges that need to be dealt with before the life sciences industry for sustained business success. A CEO conclave, Health â€“ Made in Germany, held on December 16 at the Sheraton hotel, Bangalore, provided a platform to discuss the challenges and explore ways to transform them into opportunities. The event was organized by BioSpectrum along with Germany Trade and Invest, to provide a snapshot of the various potentials that Germany has as an investment hub. One of the main hurdles is the mutual lack of awareness about the processes and protocols. Mr Narayanan Suresh, group editor, BioSpectrum, highlighted this while speaking at the event and said there needs to be dialogue between the firms of the two countries to help facilitate understanding of each other's processes and protocols. He also said that there were no intellectual property rights-related obstacles in India and added that the investment environment was cordial and this could be utilized by the German firms. Development of affordable and innovative medicines is the war cry - Dr Rajesh Jain Joint MD, Panacea Biotec Push for research Welcoming the gathering, Mr Hans Guenter Loeffler, deputy consul general, Consulate of the Federal Republic of Germany, highlighted that Germany is extremely focused on its education and research, and it can be judged from the fact that the Government of Germany is planning to increase funding to the Department of Education and Research by 11 percent despite the monetary slump surrounding the EU. â€œSo far, more than 2,000 joint projects have been successfully completed, more than 7,000 student exchanges have been made, over 2,000 scientific publications have been published and more than 400 workshops and seminars have been conducted. The Humboldt Foundation, which has around 1,700 Indian scientists, awards fellowships to conduct research for two years. Indians are among the highest number of alumni in the institute. We also have the DAAD (German Academic Exchange) service, which has helped more than 7,500 Indians secure scholarships,â€? said Mr Loeffler. Germany functions on principles of cooperation, mutual trust and respectâ€? - Mr Hans Guenter Loeffler deputy consul general, Consulate of the Federal Republic of Germany The German experience Panacea Biotec, the largest vaccine producer of India with a turnover of more than $200 million, recently set up a company (GmbH) in Munich, Bavaria. It identified that establishing a GmbH was the right kind of business presence for a foreign organization in Germany. The procedure for setting up a GmbH is straightforward, subject to proper documentation. Dr Rajesh Jain, joint managing director of Panacea Biotec, said the entire process was completed within a very short period. â€œThe simplified nature of management and administration of a GmbH ensures that the team can focus more on business aspects,â€? he said. Sharing his views on why Panacea looked at Germany as an entry point to Europe, Dr Jain said, â€œGermany is a leader in science and they also have a reputation of moving forward very swiftly. We found this by using our market research team and this made us think that Germany could be our destination.â€? He also said the experience with BfArM (the German drug regulatory agency) has been very good from the perspective of scientific advises related to guidance on CMC, pre-clinical and clinical development. â€œGermany is the third largest pharmaceutical market globally, next to the US and Japan. It has the largest market in the EU in terms of value for specialty pharmaceutical product, has a strong orientation for brand promotion and is the most respected reference member state in the EU. All these factors make Germany an attractive country for pharmaceutical investments,â€? he added. Mr Amit Chatterjee, managing director, Sartorius Stedim India, echoed the sentiments put forward by Dr Jain. He said German firms were disciplined in their approach and execution, and had zero percent tolerance for parameters that hindered their protocols. He said that since Germans were technically very skilled, working for a German firm was very satisfying. A financially stable nation A large number of Indian firms have collaborations with subsidiaries of German companies in India. However, not many Indian companies have established their businesses in Deutschland. Dr Tilo Mandry, senior director, Germany Trade And Invest, Federal Republic of Germany, was in India to understand and to find the issues that are coming in way of enhancing trade relations between the two. Dr Mandry heads Health - Made in Germany, which is an initiative of the German Federal Ministry of Economics and Technology, that aims to foster and expedite cooperation between German and foreign partners in healthcare. It is the official export and collaboration initiative of the German government for the German life sciences industry. Statistics according to Dr Mandry suggest that there are 11,700 medical device manufacturers in Deutschland, out of which 500 are designated biotech companies. Each of these firms have shown economic stability and no bankruptcy has been declared until date. So Indian firms, which have been apprehensive about investing in Germany owing to the prevailing monetary slump, can breath a sigh of relief. â€œIndian life science giants such as Dr Reddy's Laboratories and Ranbaxy have established their presence in Germany,â€? he added. Dr Mandry, while speaking about the role of the â€œHealth â€“ Made in Germanyâ€? initiative, said, â€œWe needed a platform to identify partners for distribution for in-licensing and for out-licensing for joint ventures. Thus, we started working with groups comprising representatives of German association of the healthcare industry. We have four groups for medical devices, services, pharmaceutical and biotechnology. This platform would also help India, since a lot of firms here want access to the German market.â€? Need for more initiatives Dr S D Ravetkar, senior director, Serum Institute of India, suggested that more such platforms should be organized where interactions between various organizations takes place. He suggested that since BioSpectrum has emerged as the voice of the industry, the initiative should be taken up by the publication. He pointed out that Indian manufacturers need to learn more tricks of the trade. Saptarshi Chaudhuri in Bangalore ]]> <![CDATA[BioInvest 2011: Boosting Innovation]]> https://biospectrumindia.com/news/95/4603/bioinvest-2011-boosting-innovation.html https://biospectrumindia.com/news/95/4603/bioinvest-2011-boosting-innovation.html Mon, 09 Jan 2012 16:48:00 +0530 This year, ABLE's annual event, BioInvest 2011 saw the who's who of biotech in India expressing a keen interest in capitalizing on innovation. BioInvest sought to address the two most critical barriers in the biotech industry today - funding and regulation - and ably provided a platform to bring together the industry, investors and government officials to discuss these issues and more. In a bid to accelerate biotech funding, industry body, Association of Biotech Led Enterprises (ABLE) organized BioInvest 2011 in Bangalore on December 20, 2011. The keynote address by Dr Sam Pitroda, chairman, National Knowledge Commission set the tone for thought-provoking discussions in the day-long conference. Dr Pitroda, widely regarded as the person responsible for the revolution in the telecommunications industry, spoke about the factors needed to bring about a similar one in the biotech sector in India. No stranger to innovation, Dr Pitroda, via video conferencing said, â€œThere is an urgent need to find innovative solutions for India-centric problems. The years 2010-20 have been declared as the decade of innovation and with the proposed billion-dollar innovation fund by the National Innovation Council created via private investors, we hope to promote inclusive growth by funding ingenious initiatives to improve healthcare and increase food production. Biotech holds tremendous promise in this regard and hence I urge everyone to not just look for quick fixes but to be a part of this exciting process.â€? The stage was now set for one of the most important events of the year for life sciences investors across all verticals in the biotechnology industry. Hoping to provide small and medium enterprises some advice, was the first session on the role of public and private incubators in mentoring start-ups. Ms Deepanwita Chattopadhyay, MD and CEO, IKP Knowledge park, Hyderabad; Dr Gayatri Saberwal, faculty scientist, Institute of Bioinformatics and Applied Biotechnology (IBAB), and Dr Taslimarif Saiyed, COO, Centre for Cellular Molecular Platforms, spoke about the factors which they thought led to the success of some of the start-ups incubated at their facility and the failure of some others. An important sentiment echoed by all of them was the need for the entrepreneur to have a strong focus and to not lose sight of the goal. Dr Gayatri Saberwal of IBAB, which has incubated seven start-ups till date, pointing out issues associated with having an incubator in an academic setting, said, â€œOne of the advantages for incubating a company in an academic setting is that the students get tremendous exposure to the practical aspects of a biotech company, with some of them even getting placed in those companies. However, maintaining a balance between the academic responsibilities and those towards the company proves to be tough for some.â€? Lack of sufficient funding remains to be among the top grouses for most biotech companies and it was evident in subsequent discussions. Dr Renu Swarup, senior adviser, Department of Biotechnology, highlighted some of the avenues which people could utilize. She said, â€œSmall Business Innovation Research Initiative (SBIRI) and Biotechnology Industry Partnership Programme (BIPP) are two excellent schemes that have been successful in aiding biotech professionals. One of the most exciting new initiatives is Biotechnology Industry Research and Development Assistance Council (BIRAC), which will be incorporated by April 1, 2012. BIRAC will not just be a funding agency but will provide a variety of services such as mentoring, intellectual property related support, connecting enablers to SMEs and much more, such that it acts as an industry arm of the DBT.â€? After crossing the first round of funding, many, however, face the proverbial 'Valley of Death' before they can have another round of raising funds. The general consensus was that one of the primary reasons is the inability to produce a product which can be commercialized successfully soon after the first round of funding. Most entrepreneurs gathered went so far as to call the time after the first round of funding as an 'abyss', which continues over a period of time, rather than a steep valley. Those who did successfully bridge this divide, however, said that despite the paucity of private investors willing to invest in life sciences, a strong marketable product in hand within a few years of funding can go a long way in gaining trust with investors. Intelligent diagnostics With three sessions already under way, any assumptions of the attention of the audience waning were dispelled by the exciting and enthusiastic presentations of young Indian entrepreneurs. From a microfluidics-based approach for diagnostics by Achira Labs to autologous stem cell therapy for osteoarthritis and autism by StemOne Biologicals, the sheer talent and determination on display were impressive. Another company to watch out for was Biosense Technologies, which has developed a portable non-invasive method to detect anaemia. Mr Myshkin Ingawale, CEO, Biosense Technologies, said he hoped to make a contribution towards helping make diagnostics cheaper than drugs, as opposed to the current situation. Ms Anita Shet, CEO, pinkWhale Healthcare services, spoke about how by using state-of-the-art technology, her e-Health company aimed to offer integrated telephone and internet-based healthcare services. Although the biotech industry has had a presence in India for two decades, there are fewer than 10 companies listed on the stock exchange. Exploring the reasons behind this phenomena, industry experts said, â€œThe current stringent requirements for listing and the variable valuation of shares after listing were the major deterrents to the companies from going for an Initial Public Offering (IPO). Mr Ravi Tyagi, head, Small and Medium Enterprises (SME), National Stock Exchange, elaborating about an initiative which aimed to address the issue, said, â€œOn the Prime Minister's recommendation the setting up of a dedicated exchange for SMEs was taken up. This exchange has only recently received approval from Securities and Exchange Board of India and we hope it will go a long way in aiding SMEs around the country.â€? Mr N Suresh, group editor, BioSpectrum provided an interesting perspective when he said, â€œThe government should look at raising funds for public healthcare issues from the public itself, the same way it endeavored to do in the case of Konkan Railways or the Cochin airport. As healthcare products out of biotech can serve the large population, initiatives like these could provide new sources for capital as well.â€? ABLE chose to end the conference on a high note with the winners of Biotechnology Entrepreneurship Student Teams 2011 conducted earlier this year. The winners from SASTRA University, International Centre for Genetic Engineering and Biotechnology and IIT Bombay were allowed to pitch their ideas in front of the august gathering and were presented with cash prizes. ]]> <![CDATA['India should have a stringent inspection program']]> https://biospectrumindia.com/news/95/5500/india-should-have-a-stringent-inspection-program.html https://biospectrumindia.com/news/95/5500/india-should-have-a-stringent-inspection-program.html Mon, 09 Jan 2012 16:47:00 +0530 Interview Dr Shoibal Mukherjee, chief medical officer Quintiles India Quintiles India, the only global contract research organization (CRO) in India whose study sites have been inspected and approved by the US Food and Drug Administration multiple times, has appointed Dr Shoibal Mukherjee as its chief medical officer. Dr Mukherjee represents the company's position on various government, ethical and public policy issues. He works closely with the Quintiles' clinical business team. Dr Mukherjee, a physician with an MD and DM in pharmacology with over 20 years of experience, joined Quintiles from GVK Biosciences where he was a member of the executive committee and served as senior vice president and head of clinical development strategic business unit. Prior to this, he held similar senior positions at Ranbaxy and Pfizer. He was the founder president of the Indian Society for Clinical Research and has been closely involved with the evolution of pharmaceutical regulations in the country. In an interview with BioSpectrum, Dr Shoibal Mukherjee shares his thoughts on the impact of global economic crisis on Indian CROs and issues before the company in India. Q Do you think the global slowdown has affected the CRO industry in India positively? Dr Mukherjee: I think the positive and negative influences of the global slowdown have canceled each other out, and the future of clinical research in India now depends more on internal rather than external factors. Q What advantage does India offer as compared to other APAC countries? Dr Mukherjee: India has the advantages of scale and of a large and well-qualified pool of talented investigators. We also have a more diverse disease profile as compared to both, developed and less-developed countries. In a world where an increasing proportion of global research and development effort are moving to developing country environments, the importance of India as a location for clinical research cannot be ignored. Q What are the regulatory hurdles faced by Quintiles today? Dr Mukherjee: Much like the clinical research industry in India, the regulatory environment of the country is still evolving. Ambiguity in regulations and the absence of a formal mechanism to obtain reasoned scientific advice from regulators make planning and coordination required for global drug development a challenging task. However, this is a process of evolution. There is a lot of healthy discussion on regulatory issues in India, that we believe is good for the industry. We are very open to working with regulatory bodies to bring in regulations and processes that will enhance the standards and performance of the clinical research industry in India, while ensuring that interests of patients are kept in the forefront in the next phase of development of the country as a global hub in life sciences. Q What steps can the government take to ensure that CROs abide by the regulations and eventually discourage dubious organizations? Dr Mukherjee: The country should have a stringent inspection program conducted by qualified inspectors with rigorous training and experience in the clinical research domain. In the absence of adequate resources available to the regulator, a system of third-party audits should be considered, as is done in the financial world. Q What sets Quintiles apart from its competitors? Dr Mukherjee: The quality of its people, experience base, ability to think global and act locally, and its insistence on doing the right thing. Q Which diseases are the focus of clinical research at Quintiles? Dr Mukherjee: As a CRO, we are open to accepting assignments in any therapeutic area that may be of interest to our sponsors. There is a natural tendency of sponsors to assign to India projects in therapeutic areas for which there is high patient availability in the country, so that the project meets recruitment timelines. This also ensures that there is commercial incentive to launch the product in India if and when it comes to market. Increasingly, we are finding ourselves involved with projects from local sponsors and not-for-profit organizations working in areas of domestic public health concern, such as the development of vaccines for prevention of childhood infections. Quintiles is involved with approximately 50-60 projects in India that are in the recruitment stage or active follow-up phases. We perceive significant future demand too, particularly from local sponsors. Q Tell us about the role played by local sponsors and your past collaborations. Dr Mukherjee: India has the world's highest disease burden (ranging from 40 to 60 percent) as estimated by the World Health Organization. Childhood pneumonia and childhood diarrhoea are the biggest killers, taking young lives and contributing the most to disease burden. India also carries a disproportionate amount of the world's burden of leishmaniasis (kala azar), Japanese encephalitis, leprosy and burns. The government as well as non-governmental organizations and other international sponsors are making efforts to help develop better therapies and preventive vaccines for these diseases. The need to encourage and support these endeavors cannot be overstated. Q Is there a shortage of experienced staff in clinical research? If so, what solutions do you suggest? Dr Mukherjee: Clinical research is a relatively new domain in India and even the most experienced professionals in the country have around 15-16 years of intensive clinical research experience. However, the industry has evolved considerably over the last few years. In Quintiles, most managers have experiences of eight-to-10 years or more. While the clinical research industry, being relatively small, will find ways to meet its human resource requirements, the talent shortage in the country cuts across industry lines and is expected to deepen in future. The government must spend more on quality primary and secondary educational facilities and open up higher education to private investment, doing away with entry barriers and regulatory bureaucracy while ensuring output quality by conducting national exit examinations in all major disciplines. Q Are there any particular centers in India that you plan to focus on for conducting trials? Also, tell us about the phase I facility at Hyderabad. Dr Mukherjee: Our phase I facility in Hyderabad has been developed in partnership with Apollo Hospitals Group. It is an 86-bed facility that complements Quintiles' existing phase I facilities around the globe and has been modeled to deliver the same capabilities. As new molecules emerge from discovery pipelines following a resurgence of pharmaceutical innovation in the country, we hope to be able to contribute to their development by helping customers in this part of the world navigate early development challenges and embark on global development programs. Q What are your views on the emerging market of biosimilars and how will it impact the operations of Quintiles? Dr Mukherjee: Though currently very small, the size of the biosimilars market is expected to cross $10 billion in five years from now and reach $20 billion by 2020. We had a headstart in the biosimilars segment because of the absence of clear regulations for biosimilars in the country and now we have more companies in India planning to enter the biosimilars market than anywhere else in Asia. Quintiles is keen to help these companies navigate the complex global biosimilars regulatory pathway. It is emerging as a partner of choice for the development of biosimilars for companies elsewhere in Asia and we hope that will be the case in India too. Q How do you see your role evolving at Quintiles and how will it enhance business in India? Dr Mukherjee: I hope to be able to help the organization align itself to the needs of the healthcare and pharmaceutical segments in India and move in step with evolving regulations. By doing so, Quintiles can begin to be seen as an essential part of the growth of drug development science in India, helping bring healthcare solutions to patients and to a country that bears the world's largest burden of disease. Manasi Vaidya in Bangalore ]]> <![CDATA['We expect double digit growth in the coming years']]> https://biospectrumindia.com/news/95/1949/we-expect-double-digit-growth-in-the-coming-years.html https://biospectrumindia.com/news/95/1949/we-expect-double-digit-growth-in-the-coming-years.html Mon, 09 Jan 2012 16:40:00 +0530 Interview Mr Umesh Pawa, MD, AB SCIEX India AB SCIEX, a global leader in life sciences analytical technologies, recently acquired the mass spectrometry business of Labindia Instruments, a leading life sciences solutions service provider in India. AB SCIEX's expansion of its commercial operations in India is expected to create new opportunities for customer interactions, collaborations and innovation. Headquartered in Gurgaon, the company has a workforce of over 100 people and offices at almost all prime locations in India. BioSpectrum spoke to Mr Umesh Pawa, managing director, AB SCIEX India, on the recent acquisition, market trends and the company's plans. Q What was the objective behind this acquisition? Mr Umesh Pawa: The objective behind this move was to leverage the global strength of AB SCIEX and Labindia's expertise in the India market to have a direct presence in the country. This acquisition reflects AB SCIEX's increasing focus in India, combining its global resources, world-class scientific expertise and product development leadership with well-established, local expertise and on-site support to advance science and respond to the growing needs of India's scientific community. The transition of business, including customer relationships, personnel and application support facilities to AB SCIEX is a direct result of the successful track record that AB SCIEX and Labindia have had as partners in India. Q How big is the mass spectrometry market in India? What is your market share? Mr Umesh Pawa: The industry indicators suggest that the overall mass spectrometry business in India is in the range of $50 million and $60 million. AB SCIEX is consistently cited as having the highest market share, and we anticipate double digit growth in the coming years. Q What are the products and services offered by you? Mr Umesh Pawa: We have been the pioneers in the field of liquid chromatography and mass spectrometry (LC MS) with over 630 patents registered. AB SCIEX has more than 20 years of history in innovation and is a market leader in mass spectrometry, which is a workhorse analytical technique for a wide variety of scientific applications, including food contamination testing, environmental analysis, biomedical research, pharmaceutical development, forensic toxicology and vitamin D analysis, among other emerging applications in clinical research. The company has been actively involved in applying the power of mass spectrometry to assist in efforts to protect the health of India's vast population. AB SCIEX, in 2010, supplied a food safety testing solution to six major laboratories under the pesticides monitoring network project by the Ministry of Agriculture to help reinforce new food safety standards through better monitoring for contamination. Q What are the current market trends in the segment? How are you catching up with the same? Mr Umesh Pawa: There has always been a need for technology that will offer both quantitative and qualitative powers in one instrument to enable detection and characterization of molecules at the lowest abundances. While triple quadrupoles are known to have the highest quantitative sensitivity, high resolution and accurate mass instruments are used for characterization. AB SCIEX launched the TripleTOF 5600 System, which has powers of both these instruments, offering both qualitative and quantitative features in one technology. It has proved to be very helpful in several fields, such as metabolite identification, proteomics research, biomarker discovery, environmental and food testing, lipids analysis, among others. We have been able to develop the technology due to which these complex analysis have become much easier now. We have also brought down the analysis time from weeks to days by combining the quantitative and qualitative work flows. Q Do you plan to expand into other segments as well? What is your future outlook? Mr Umesh Pawa: AB SCIEX is focused on the LC-MS and Maldi Tof market. We see great potential for the use of mass spectrometry to expand into other segments. Expanded use of mass spectrometry for a variety of applications will take the power of this workhorse technology well into the future. Q What are the challenges before biosuppliers? Mr Umesh Pawa: There are several challenges that, if addressed with collaborative efforts and consensus, could help the scientific community in the country. We need to make changes in the tender processes to allocate equal weightage for quality and performance, thereby enabling scientists to procure products that offer the best value for money instead of the current two-bid system, which prefers the L1 bidder. Changes in the customs duty structure, thereby lowering the entry barriers for adaptation of this advanced technology, would also be welcomed. Allowing instruments to come into the country for customer evaluation and subsequent purchase without tax implications during the evaluation phase is one of the directions that should be looked at towards advancing science in the country. Rahul Koul in New Delhi ]]> <![CDATA['Logistics is a crucial enabler']]> https://biospectrumindia.com/news/95/2271/logistics-is-a-crucial-enabler.html https://biospectrumindia.com/news/95/2271/logistics-is-a-crucial-enabler.html Mon, 09 Jan 2012 16:04:00 +0530 Interview Mr Christoph Remund, CEO, DHL India manufactures majority of the world's total vaccines. Domestic biotech companies are aggressively looking to tap the biosimilar space, with the help of a strong logistics set up that is based on collaborations and partnerships. DHL, along with the Organization of Pharmaceutical Producers of India, recently came out with a white paper, which draws on this strong connection between biotech companies and their need for logistical support. In conversation with BioSpectrum, Mr Christoph Remund, CEO, DHL global forwarding, India, throws light on the logistics scenario in the country and the company's plan for India. What are the salient features of the white paper on 'Transforming Life Sciences Logistics in India'? 'Transforming Life Sciences Logistics in India' delves into the competitive landscape of the life sciences industry and analyzes how logistics can be a crucial enabler of the growing life sciences sector in India. The study focuses on fundamental issues and offers solutions with thought leadership. The study highlights 12 assets and enablers that need to be implemented in order to achieve world-class life sciences logistics in India. Some of these include setting up dedicated pharmaceutical zones at airports, goods and services tax implementation, faster co-ordination amongst all ground handling agencies, multi-user warehouses and shared reefer vans and ocean freight containers, maintaining the supply chain integrity by using latest technology, such as RFID, GPS and anti-counterfeit equipment. How can public-private partnerships transform the dynamics of the life sciences logistics sector in India? Encouraging existing public-private partnerships helps achieve stronger momentum on life sciences logistics infrastructure. These partnerships could be leveraged in areas such as construction of connecting roads to link pharmaceutical hubs to major highways; multi-user temperature controlled warehouses in strategic areas and promoting free trade zone (FTZ) facilities at key locations. The government and pharmaceutical companies could also work towards making India a hub for secondary manufacturing of pharmaceuticals, including activities like packaging and labeling. What opportunities does India offer to DHL? In India, the manufacturing of generics, biosimilars, vaccines and biotech products has increased significantly. There has also been a major expansion in the export outflow as well as domestic consumption. Although a cold chain is prescribed for just 11 percent of ethicals and generics, it is crucial for biologicals, including vaccines and biosimilars, due to their extremely sensitive nature. At DHL, the material is moved in international IATA-approved packaging and it offers the widest range of packaging options. Temperature controlled logistics (TCL) is an end-to-end logistics solution and covers the entire supply chain of clinical trials. DHL has the capability of managing the entire supply chain of clinical trials. What investments has DHL made in the life sciences sector in India? We continue to invest in developing our capabilities across the logistics value chain and will be adding new infrastructure in terms of build-to-suit warehouses, a FTZ facility in Hyderabad and Mumbai, and new solutions for temperature controlled ocean freight. Nayantara Som in Mumbai ]]> <![CDATA[Nano Biotechnology: The next frontier to conquer]]> https://biospectrumindia.com/news/95/5267/nano-biotechnology-the-next-frontier-to-conquer.html https://biospectrumindia.com/news/95/5267/nano-biotechnology-the-next-frontier-to-conquer.html Mon, 09 Jan 2012 15:50:00 +0530 Poised to be a trillion dollar industry by 2015, nanotechnology holds the promise to address a multitude of issues in varied industries by scaling down the size of materials to one billionth of a meter. After creating a revolution in electronics and material sciences, biological sciences seem to be the next frontier to conquer for nanotechnologists In 1952, Dr Richard Feynman gave a lecture 'There is plenty of room at the bottom' on the possibility of manipulating matter on an atomic scale. That single lecture not only gave birth to an idea about nanotechnology, but also compelled scientists worldwide to start innovating in fields ranging from medicine to electronics, while using the principles of nanotechnology. Now over 60 years later, Prof C N R Rao, chair of the scientific advisory council to India's Prime Minister and many other eminent scientists are of the opinion that nanotechnology is set to be a trillion dollar industry by 2015. At the recently concluded Bangalore Nano 2011, scientists and industry representatives expressed hopes about the nanotechnology industry. The fact that nanotechnology is already a part of our lives in many ways was an eye opener for everyone present at the event. PacliALL, a chemotherapeutic drug for metastatic breast cancer by Panacea Biotec, which won the BioSpectrum Product of the Year award this year, is an example of use of nanotechnology in medicine. The packaging of the drug in nanoparticle form can not only help reduce adverse effects such as severe anaphylaxis and sensory neuropathy, but also increase efficacy by three times as compared to conventional solvent-based form of the drug Paclitaxel. Analysts estimate that the global market for chemotherapeutic drug is more than $500 mllion, thus emphasizing the benefits of utilizing nanotechnology in drug delivery. Broadly, nanotechnology is said to have applications in biosciences drug delivery, in tissue engineering and in therapy. Explaining how nanoparticles play an important role in drug delivery, Dr Shanthikumar Nair, director, Nanosciences, Amrita University, says, â€œMost of the promise that nanotechnology holds in biological sciences is attributed to anti-cancer therapy. Extrinsic nanomedicine that encompasses the technology in which we package the drug in a nanoparticle by using linkers, such as polyethylene glycol, forms a major chunk of nanomedicine. Drug delivery using carbon nanotubes for chemotherapy has been demonstrated, in clinical trials to be more specific to the particular target than if present in the normal form. This not only allows for a more targeted delivery but also allows for a more sustained and prolonged release of the drug. FDA-approved drugs such as Abraxane for metastatic breast cancer; Copaxone, a multiple sclerosis drug; DaunoXome for HIV related Kaposis sarcoma; and PEGIntron for the development of chronic hepatitis C vaccine are some examples of nanoparticle-based therapeutics currently in use, with many more in various phases of clinical trials. The major road block to developing nanoparticle-based therapeutics remains to be the removal of these nanoparticles from the body. Apart from these applications, nanoparticles are being increasingly looked upon in the field of medical imaging. Dr Rinti Banerjee, professor, Center for Research in Nanotechnology and Science, IIT Bombay, explains, â€œCurrently, advanced research is being carried out where iron nanoparticles are being used for phase contrast imaging. For example, on injection, most cells allow the entry of these nanoparticles except the tumor cells. This can help pinpoint the site of the tumor in an MRI scan. This technology is already in use in many parts of the world for phase contrast imaging.â€? Combining imaging with therapy, Dr Banerjee elaborated about theranostic nanomedicines, saying, â€œNanoparticle carriers can be made heat responsive. Hence, when they reach the location of the injury, application of heat to that particular area can cause the carrier to release the nanoparticle drug at the precise location. This form of targeted therapy holds a lot of promise for use in cancer. The carriers can also be made sensitive to stimuli that are commonly observed in diseased conditions. This principle can also be applied for release of growth factors.â€? Stem cells have always held great promise in the field of regenerative medicine. But for stem cells to be effectively used for regenerating damaged tissue, there is a crucial need for a suitable scaffold. Explaining how nanoparticles can be a solution to this issue, Dr Swaminathan Sethuraman, director, Center for Nanotechnology and Advanced Biomaterials, SASTRA University, says, â€œThere is a need to prepare biocompatible scaffolds or matrices that can act as extracellular matrices. Nanofibres made of biodegradeable material, such as chitin or fibrin, hold the key for use in tissue regeneration. Human fibroblasts or stem cells can, in this manner, be allowed to proliferate in the area of injury for wound healing and wound contraction. These nanofibres can also be loaded with growth factors to accelerate the process. We have already applied for a patent regarding the technology on similar lines.â€? Other futuristic technologies include nanoarrays where probes in nanomolar quantities are linked on a chip for the detection of disease pathogens, akin to microarrays. The minute quantities of the probes would require smaller volumes of samples and also allow a large number of samples to be screened at the same time. The Indian perspective Keeping in line with the growing need, the Government of Karnataka has recently planned to build a new Nano park near Bangalore under the aegis of the nationwide Nano mission. This park hopes to incorporate an incubation center for early-stage entrepreneurs in nanotechnology. It also hopes to further higher education in nanotechnology in order to prepare a large group of skilled individuals in nanotechnology. Speaking at Bangalore Nano 2011, Mr Anand Vasant Asnotikar, Minister for Science and Technology and Fisheries, Government of Karnataka, said, â€œExpression of Interest has already been called for development of Nano Park on a public-private partnership mode. This initiative will give a major fillip to the nanotechnology industry to blossom in the state in the coming years.â€? The Karnataka government is providing an acre of land for setting up a â€œNano Labâ€? by the Jawaharlal Nehru Center for Advanced Scientific Research in Bangalore. Also, the Indian Institute of Nano Science and Technology is being established with funding from the Government of India under the Nano Mission at an estimated cost of 100 crore, for which the state has already allocated 14 acres on Tumkur Road. A similar park is also going to come up in Chandigarh. The great promise of nanomedicine is evident, but clinical translation and commercialization of most of these therapies remain difficult. Extensive research is required to be able to capitalize on the advantages of nanomedicine. Manasi Vaidya in Bangalore ]]> <![CDATA['Farmers should get direct subsidies in cash']]> https://biospectrumindia.com/news/95/1797/farmers-should-get-direct-subsidies-in-cash.html https://biospectrumindia.com/news/95/1797/farmers-should-get-direct-subsidies-in-cash.html Mon, 09 Jan 2012 15:44:00 +0530 Interview Mr M Prabhakar Rao, chairman and MD Nuziveedu Seeds Started in the 1970s by late Mr M Venkataramaiah as a cotton seed company in Hyderabad, Nuziveedu Seeds (NSPL) aimed to address the severe shortage of quality cotton seeds at affordable prices. It continues to follow that ideology even today. NSPL is the most profitable division among all the ventures of Nuziveedu Group. NSPL introduced its Bt cotton varieties, Bunny and Mallika, in 2005 and since then has become the leader in Bt cotton seeds providers with a market share of over 40 percent. It witnessed a three percent drop in its growth rate of Bt cotton seeds market in 2010-11 against previous year's growth rate of 31 percent. But Mr M Prabhakar Rao, chairman and MD, NSPL, remains positive about the future. In a conversation with BioSpectrum, he talks about the challenges before the company and its future growth plans. What is your projected growth for next year and what are the major challenges before you? Mr Rao: We look forward to more than 30 percent growth in the coming year. The toughest challenge we face today is the seed subsidies offered by the government. These disturb the market dynamics and create an unequal playing field for distribution between different states. Andhra Pradesh and Karnataka have a balanced system of distributing seed subsidies between private and public players that other states should try to adopt. The best case scenario would be if farmers get direct subsidies from the government in the form of cash, so that they have the power to choose from the different seed varieties available. The Unique Identification (UID) scheme would be an ideal vehicle for implementing such a program. What is your opinion on the GEAC ruling that companies must obtain no objection certificates from states for field trial of GM crops? Mr Rao: We are ready to follow all the rules imposed by the government, but an effort should be made to speed up the process. Otherwise, the product will become irrelevant by the time it reaches the market. What are your views on the recent developments on Bt crops? Mr Rao: Applying Bt technology in everything is obviously not good. It has to be well thought over and researched in a scientific manner. The technology has been of tremendous use to the farmers of India and will continue to do so. However, the regulatory procedure has to be strictly followed to avoid any sort of controversy. What is NSPL's business strategy in a competitive market? Mr Rao: I think farmers in India and elsewhere are very smart and hence choose the right product after a lot of deliberations. They prefer brands that they can trust and those that are recommended by others. In this scenario, it is very important to build a good name. Also, seeds are the most valuable input for any crop offering the highest cost benefit ratio. Technology adoption also is fastest unlike other components of agriculture that have logistical problems associated. A case in point is Bt cotton. Within 10 years of its introduction, Bt cotton seeds now account for 85 percent of the land under cotton cultivation. There is a healthy competition in the bioagri industry which allows everyone to grow, but it is the farmer who ultimately decides the fate of any product based only on its performance. Tell us about the R&D projects at NSPL? Mr Rao: We have set up a state-of-the-art R&D facility utilizing a 250 crore-investment from Blackstone group in 2008. We are focusing on developing drought tolerant paddy, disease-resistant rice varieties and hybrid vegetable crops along with GM maize. We hope to be able to put another Bt crop out in the market in the next five years. NSPL has been long partnering with public and private enterprises for R&D. We have collaborated with the University of Agricultural Sciences, Bangalore; Indian Agriculture Research Institute, Delhi; and the International Centre for Genetic Engineering and Biotechnology, New Delhi, for the development of newer varieties of seeds. Do you plan to leverage on your extensive marketing network to reach out to farmers? Mr Rao: The marketing network is spread across 16 states with more than 55,000 dealers and sub-dealers. The marketing team currently constitutes about 32 percent of the total work force and is one of the factors that sets us apart from our competitors. Regular outreach sessions are carried out for the farmers that inform them of the new products available in the market. Currently, we are laying the groundwork for a couple of other services along with seeds for farmers. In the near future, we would like to use this marketing network for providing fertilizers and pesticides and other such agriculture-based products. What are your suggestions to overcome economic inequity among farmers? Mr Rao: Currently, a sizable amount of the farmer population suffers from lack of access to and availability of good quality seeds. India should look at adopting innovative solutions to address this problem. For example, in Latin America, farmers pay royalties for seeds from the produce output. In India if we adopt a similar model, seed companies can collect royalties from farmers for using GM seeds, thus allowing farmers access to the new technology. Manasi Vaidya in Bangalore ]]> <![CDATA['Preventive healthcare in India needs more investment']]> https://biospectrumindia.com/news/95/2416/preventive-healthcare-in-india-needs-more-investment.html https://biospectrumindia.com/news/95/2416/preventive-healthcare-in-india-needs-more-investment.html Mon, 09 Jan 2012 15:42:00 +0530 Interview Dr Harish Iyer, CEO, Shantha Biotechnics Shantha Biotechnics was established in 1993 with the sole purpose of developing efficacious and cost-effective vaccines and therapeutics that are within the reach of the common man. In 2009, the company was acquired by Sanofi Pasteur, the vaccines division of Sanofi, that provides more than one billion doses of vaccine each year. In June 2011, Sanofi appointed Dr Harish Iyer as the chief executive officer of Shantha Biotechnics. Dr Iyer, a graduate in chemical engineering from Indian Institute of Technology, Madras, and with a PhD from Rensselaer Polytechnic, New York, US, has over 15 years of experience in biotechnology and biopharmaceutical research and development. He has worked with Genentech, IDEC Pharmaceuticals and Biocon. Dr Iyer, who reports directly to Mr Olivier Charmeil, president and CEO of Sanofi Pasteur, and a member of the Sanofi Pasteur management committee, elaborates his vision for Shantha, plans of obtaining the pre-qualification status for Shan5, Shantha's pentavalent vaccine, and the company's exciting pipeline of other vaccines. How has the shift been from being the head of R&D at a leading biotechnology company to being the CEO of a pioneering vaccine company? Dr Iyer: I think it has been excellent. My previous role focused more on R&D, whereas now I have a very broad role that allows me to oversee finances and manufacturing along with commercial and regulatory aspects. Also, Shantha is a very exciting place to work, with great potential and a promising future. I work closely with Sanofi Pasteur and also interact with World Health Organization (WHO), both of which have been very rewarding. Has there been any change in the business model of Shantha since Sanofi acquired majority stakes in it? Dr Iyer: The focus at Shantha was and continues to be on producing vaccines for the developing world. In the past, Shantha has dabbled in monoclonal antibodies and therapeutics. In more recent times, we have made a conscious effort to focus singularly on our area of strength, which is vaccines. Our aim is to make high quality affordable vaccines and get pre-qualified by WHO. Our primary markets are in developing countries of Asia, Latin America and Africa through Global Alliance for Vaccines and Immunization (GAVI), United Nations Children's Fund, because there is a very real need for vaccines in these countries. Tell us about the product pipeline at Shantha? Dr Iyer: Shantha has always emphasized on research and development and it continues to do so. Currently, we are in the midst of developing a rotavirus vaccine. Over 100,000 children die each year of rotavirus infection. There is a clear need and we want to fulfill it and so are developing a vaccine licensed from National Institutes of Health (NIH) with the goal of making it accessible to all developing countries. It is currently in clinical trials and we hope to get it approved by 2015. We have also used innovative technology for the cholera vaccine, which was co-developed with the International Vaccine Institute. Earlier, the only available vaccine of cholera was primarily used in a travelers market with a high price. We have now introduced Shanchol, which is less than $2 per dose and approved by the WHO. We are supplying it as and when required, especially in areas hit by flood or earthquake. We are also doing a lot of research on a vaccine for Human papilloma virus (HPV) as the vaccines currently available for cervical cancer are very expensive. We hope to have an affordable vaccine in the market by 2018. Another vaccine of exceptional interest to us are the hexavalent vaccine for hepatitis B, haemophilus influenzae, diptheria, tetanus, pertussis and an inactivated polio vaccine (IPV). Studies have shown that once the number of cases go down to a certain level, IPV is a better choice for routine immunization against polio. What is your opinion on the National Vaccine Policy in India? Do you think the inclusion of vaccines for neglected diseases in the National Immunization Program can help curb the fatalities? Dr Iyer: The National Vaccine Policy published earlier this year looks very positive and is definitely a welcome start to initiate discussions and take concrete steps. There is a need for political will to back the National Vaccine Policy for the public to reap benefits. The provisions for incorporating vaccines in immunization programs that are relevant locally in the policy document are very sound. Almost 50 percent of the vaccines produced in the world are manufactured by the industry in India and, if given adequate support, they can make a huge difference on the healthcare scenario in our country. Overall, healthcare, especially preventive healthcare in India needs much more investment. For me personally, preventive healthcare was one of the things that attracted me to Shantha, as it allows us to truly make a strong impact on public health in the developing world with affordable vaccines. What has been the impact of a vaccine giant such as Sanofi acquiring Shantha Biotechnics? Dr Iyer: The impact of Sanofi and its vaccine division Sanofi Pasteur has been huge. The technical expertise and experience that Sanofi Pasteur brings to vaccine development and manufacturing is very helpful. Additionally, they bring in global quality consciousness into our vaccine development space. Sanofi is also investing here, thus, enabling us to strengthen our R&D efforts. What do you think of competition from other vaccine companies developing similar vaccines? Dr Iyer: The markets that we are competing in are internationally funded markets, which work on competition based on tenders. So, one has to be efficient with an eye on costs. However, UNICEF generally seeks tenders from more than one vaccine manufacturer and hence there is room for all in this market. What are your plans for Shantha Biotechnics? Dr Iyer: We would like to complement the present portfolio of Sanofi Pasteur. In the long run, Sanofi plans to manufacture some of its products at the Shantha facility in Hyderabad, so that they can be more affordable in India and other countries in the southern hemisphere. We are also looking forward to bringing Shan5 back into the market as it offers ease of administration by combining all the vaccines in one injection. Once we have Shan5 and these products on track, we will go ahead with more vaccines for diseases such as measles, rabies and hepatitis A. Also, we hope to introduce IPV before a hexavalent vaccine that is in the pipeline. Additionally, we are in the process of building a very large plant in Shameerpet, a few kilometers from Hyderabad, for manufacturing the rotavirus and Shan5 vaccines. Manasi Vaidya in Bangalore ]]> <![CDATA[PPP:On a mission to cure diseases]]> https://biospectrumindia.com/news/95/2824/pppon-a-mission-to-cure-diseases.html https://biospectrumindia.com/news/95/2824/pppon-a-mission-to-cure-diseases.html Mon, 09 Jan 2012 15:38:00 +0530 In this issue of BioSpectrum, the public-private partnership (PPP) case study series showcases the work of organizations that are on a mission to provide innovative and cost effective ways to tackle diseases in humans and animals. While one of the PPP initiatives promises to be a solution to the dreaded 'goat plague' in animals, another appears to be an effective way in which Kala Azar could be treated in humans. The other company featured in the series has utilized funding by the government to find home-grown solutions to rapid detection of nucleic acids. Revelations Biotech, a public-private partnership between BIPP and IMTECH, has developed innovative platforms that could help in faster detection of nucleic acids. Lifecare Innovations with funding from the DBT and the DSIR has emerged as a true PPP initiative with each partner playing a successful role. Indian Immunologicals has succesfully commercialized a unique viral vaccine for Peste des petits ruminants. The veterinary vaccine was developed by the IVRI, which utilized monetary grants provided by the ICAR. ]]> <![CDATA[Mission: To protect livestock from viral attack]]> https://biospectrumindia.com/news/95/2768/mission-to-protect-livestock-from-viral-attack.html https://biospectrumindia.com/news/95/2768/mission-to-protect-livestock-from-viral-attack.html Mon, 09 Jan 2012 15:36:00 +0530 Funding from the Indian Council for Agricultural Research helped the Indian Veterinary Institute to develop a unique viral vaccine, which was later successfully commercialized by Indian Immunologicals Reported first in 1989 from Tamil Nadu, Peste des petits ruminants (PPR), also known as goat plague, is a highly contagious viral endemic disease in India. It affects mainly sheep and goats and occasionally small ruminants living in the wild. Since there was no vaccine available in India, it resulted in losses amounting to millions. The only option was to use the attenuated tissue culture rinderpest (TCRP) virus vaccine or vaccine developed by Diallo and others (1989) in France using lineage-I PPR virus, which had major drawbacks. Meanwhile, the Indian Veterinary Research Institute (IVRI), which is funded by the Indian Council of Agricultural Research (ICAR), developed a live-attenuated homologous vaccine from an Indian strain of PPR virus that is currently prevalent in India. The IVRI, Izatnagar, Uttar Pradesh, undertook the research for the development of vaccine against PPR using a lineage 4 virus isolated in India. The scientists found that the introduction of wild virus (goat -derived virus) in unnatural hosts (vero cells) results in attenuation of the virus. It has the ability to induce protection against specific diseases without causing any pathogenicity. The developed vaccine was tried on animals at the laboratory and then at the state level. At a later stage, the technology was transferred to the National research Development Corporation (NRDC) and eventually commercialized to Indian Immunological, Hyderabad. The NRDC agreement with Indian Immunological was signed during 2004 and 25 lakh was received as licensee fee (70 percent share for the IVRI) with a royalty at three percent for 10 years. Indian Immunological launched Raksha-PPR vaccine in 2006 and has sold vaccines worth more than 2 crore so far. The way forward Currently, there are approximately 60 million sheep and 125 million goats in India. The annual loss due to PPR in the small ruminants (about 200 million) in India is approximately 180 crore. Thus technology has emerged as a major development in India on animal healthcare sector, with the IVRI making more than 100 lakh in annual sale of the vaccine since 2006. Mr K V Balasubranaiam, MD, Indian Immunological, says, â€œThe market response has been quite good for Raksha-PPR. IIL currently sells about 15 million doses of this vaccine. The demand for this vaccine will get a boost with the new National Control Programme of PPR to eradicate PPR from the country, initiated by the Government of India on similar lines as the successful Rinderpest eradication programme.â€? â€œThe price of PPR vaccine is about 4 per dose. IIL has an installed capacity to produce 40 million doses of PPR vaccine per annum. Some of the state government vaccine production units, such as Andhra Pradesh and Karnataka also produce PPR vaccine and supply to the adjacent states,â€? added Mr Balasubramaniam. Being potent, cost-effective and more convenient for field application, the use of PPR vaccine is expected to increase the production of small ruminants and profitability, especially in case of small and marginal farmers. Also, the export of vaccine to neighboring Asian countries where viruses of similar genetic make up are known to circulate, will boost the financial health of companies as well as contribute to the overall economy. Rahul Koul in New Delhi ]]> <![CDATA[Mission: Cost-effective cure for kala azar]]> https://biospectrumindia.com/news/95/1741/mission-cost-effective-cure-for-kala-azar.html https://biospectrumindia.com/news/95/1741/mission-cost-effective-cure-for-kala-azar.html Mon, 09 Jan 2012 15:34:00 +0530 Funded by the Department of Biotechnology and supported by the Department of Scientific and Industrial Research, the creation of liposomal amphotericin B by Lifecare Innovations, is a true example of a public-private partnership, where each of the partners have played their role successfully Amphotericin B, an antibiotic obtained from Streptomyces sp, is known to be one of the most potent anti-fungal agents, but is applied topically because of its toxicity. The alternative for this drug was successfully developed by Gurgaon-based Lifecare Innovations. Liposomal amphoterician B uses liposome as a carrier and delivery system and can carry the drug at the specific site. It is also required in much lower concentration. The initial research to make an affordable substitute of AmBisome (a US product) at the Department of Bio-chemistry, Delhi University, was supported by the Department of Biotechnology (DBT). After the formulation development was completed proving the efficacy and substantiated pre-clinical work, the results were transferred to Seth GS Medical College and KEM Hospital, Mumbai, for clinical evaluation following which the clinical trials for kala azar were successfully completed and the technology was formally handed over to National Research Development Corporation (NRDC) by DBT for licensing and commercialization. Although the commercialization of technology failed to take off with first licensee Ace Diagnostics and Biotech Limited, the same became a huge success when it was licensed to Lifecare Innovations in 1999. With the license fee of 25 lakh and royalty of three percent for 10 years to commercialize the product, the company was also asked to further improve the formulation to overcome the doses related toxicities of amphotericin B as compared to the imported lipid formulations such as AmBisome, Ampholip (Abelcet) and Amphocil (Amphotek). Further R&D at Lifecare Innovations led to the commercialization, which was supported by the Department of Scientific and Industrial Research through program aimed at Technological Self Reliance (PASTER scheme). Also a pre-proof-of- concept on the development of affordable, toxicity-free amphotericin B loaded liposomal preparation for treatment of Kala Azar was supported by DBT through its Small Business Innovation & Research Initiative (SBIRI) scheme. â€œWe took the laboratory-scale technology of DBT and we complemented it with nanosomization to make nanosomes of liposomal amphotericin B,â€? said Dr JN Verma, MD, Lifecare Innovations. The way forward The product, liposomal amphotericin B, which is marketed by Lifecare Innovations as â€œFUNGISOME i vâ€?, contains cholesterols essential for minimizing toxicity of Amphotericin B to a safe level. It converts into several small unicellular liposomes, thereby substantially increasing the therapeutic index. â€œFUNGISOME i.v.â€? requires sonication for application which enhances the therapeutic index of the drug and the administration can be done in one hour. According to the company, the product is the least toxic drug available in the country in its category. Unlike the imported drug, it comes in various doses thereby reducing wastage and cost, also being less than one-tenth the cost of the imported equivalent. Furthermore, the company also developed a liposomal dithranol for the treatment of psoriasis. The company has developed an anti-TB formulation in collaboration with the Post Graduate Institute (PGI), Chandigarh. Rahul Koul in New Delhi ]]> <![CDATA[Mission: Technology for diagnostic efficiency]]> https://biospectrumindia.com/news/95/6809/mission-technology-for-diagnostic-efficiency.html https://biospectrumindia.com/news/95/6809/mission-technology-for-diagnostic-efficiency.html Mon, 09 Jan 2012 15:32:00 +0530 The support from BIPP funding and collaboration with IMTECH Chandigarh, helped Revelations Biotech, Hyderabad, to develop unique technology platforms for rapid detection of nucleic acids, which could help in diagnosis of various diseases on time Nucleic acid detection is one of the most reliable ways of disease diagnosis. However, technological limitations are involved in nucleic acid hybridization methods for routine molecular diagnosis. This prompted Hyderabad-based Revelations Biotech to think differently. Revelations developed rapid thyroid stimulating hormone (TSH) quantification technology in-house by employing complex genetic engineering and also made significant progress in developing rapid T3 and T4 quantification systems. Revelations is developing a unique technology platform with which small amounts of DNA and RNA can be readily detected in a single reaction tube in less than 30 minutes. A genetically engineered protein scaffold was designed to report each probe hybridization event in solution after exponential amplification of signal. Coupling this technology with polymerase chain reaction (PCR) applications will bring out a novel strategy for quantitative detection of nucleic acids. The Biotechnology Industry Partnership Programme's (BIPP) support for this project was timely and added to the confidence of delivering the product within time. Collaboration with the Institute of Microbial Technology (IMTECH), Chandigarh, helped to propel the project ahead of the schedule. Dr Ravi Chandra Beeram, MD, Revelations Biotech, said â€œWe harness complex scientific underpinnings from interdisciplinary sciences, such as molecular biology, structural biology and protein engineering, to discover novel technologies. Revelations started with a small team of people with innovative ideas to invest.â€? Revelations Biotech, which was founded at Secunderabad, now has a state-of-the-art laboratory in the life sciences incubator of IKP Knowledge Park, Hyderabad. Highly appreciative of the BIPP support, Dr Chandra said, â€œTo fuel innovation, the BIPP is perfectly positioned where the technical screening committee identifies societal needs and partners with industry and further ensures the outcome of R&D.â€? The way forward Utilizing these platform technologies, Revelations in collaboration with a Hyderabad-based biotech organization is developing a novel and economical insulin production technology with the aim of making insulin affordable to all sections of the developing and the under-developed world. The company plans to launch a thyroid quantification kit by middle of 2012. The company also plans to raise the seed capital by offering technology consultancy to one of the big US-based MNCs that has shown interest. The company has been investing in development of technology platforms and the funds required are raised from services, directors' contributions and public funding programs like the BIPP. It also offers macro molecular crystallography services to pharma clients to determine atomic coordinates of small molecule-receptor interactions. Citing importance of novel healthcare technologies to meet the growing demands and the changing demographic patterns in the developing world, Dr Chandra said, â€œIn the absence of such program, linking innovation to business is difficult in the country.â€? Rahul Koul in New Delhi ]]> <![CDATA[Spearheading innovation]]> https://biospectrumindia.com/news/95/1774/spearheading-innovation.html https://biospectrumindia.com/news/95/1774/spearheading-innovation.html Mon, 09 Jan 2012 15:29:00 +0530 With the burden of diseases increasing by the day around the world, the need to innovate in diagnosis and treatment of disorders is becoming necessary now more than ever. BioSpectrum looks at two companies where the chief scientific officers have gone off the beaten path to discover new platform technologies using the tools of biotechnology to treat known disorders. ♦   Dr Pradip Majumdar of Mitra Biotech and his team have come up with the Oncomics platform technology, which has the potential to revolutionize personalized cancer cure. ♦   At Transgene Biotek, Dr Vijayan has inspired breakthrough research in the area of therapeutic vaccine for HIV, apart from an R&D pipeline for humanized monoclonal antibodies and work on transdermal route of delivery for insulin. ]]> <![CDATA[Technology to target HIV, cancer]]> https://biospectrumindia.com/news/95/2379/technology-to-target-hiv-cancer.html https://biospectrumindia.com/news/95/2379/technology-to-target-hiv-cancer.html Mon, 09 Jan 2012 15:11:00 +0530 Dr Vijayan V VP, R&D operations Transgene Biotek Recently in the news for out-licensing their technology to produce human erythropoetin, Transgene Biotek has had an illustrious past with developing novel technologies to produce a span of products, including monoclonal antibodies, proteins and biogenerics. Leading the operations from the front is Dr Vijayan V, head of R&D, Transgene. Dr Vijayan believes that finding novel ways to target diseases such as HIV, diabetes and cancer is important in order to make a breakthrough. Highlighting their commitment to creating useful intellectual property, Dr Vijayan mentions that Transgene has applied for 30 patents in the last six months. Dr Vijayan has over 24 years of multifaceted experience in different biotechnology companies. After completing his PhD in microbiology from Pondicherry University, he worked at the Vector Control Research Center on insecticidal antibiotics. He went on to work at Spic Pharma, where he helped develop the protocols for production of up to 1,000 tonnes of Penicillin, the largest quantity producible at that time. Later, during his stint at Indian Immunologicals, where he was involved in the development of the rabies vaccine, he got further insight into research and manufacturing aspects of vaccines. He has also served as the head of the biotech division at Cadila Pharmaceuticals where he helped start the production of recombinant erythropoetin from scratch. One of the major breakthroughs in research at Transgene has been in the area of a therapeutic vaccine for HIV. â€œIn AIDS, the humoral immunity or specifically the gp120 B cells suppress the cell mediated immunity consisting of T cells. This prevents the necessary clearance of the HIV virus from the body. We have developed a novel toxin protein that selectively targets and inhibits the gp120 B cells. This form of therapy will only target this subset of B cells, and hence will not negatively impact the overall immunity. It has been characterized in vitro and is in pre-clinical trials. We hope to develop a therapeutic vaccine on these lines that could help restore the immunity in HIV patients,â€? explains Dr Vijayan. Transgene is using a similar immunomodulation approach in the treatment of multiple sclerosis. Dr Vijayan was already well-versed in the manufacturing aspects of monoclonal antibodies, when he embarked upon the R&D pipeline for humanized monoclonal antibodies. These antibodies are directed towards extracellular ligands present on cancerous cells, such as multiple myeloma and esophageal cancer. These have shown up to 90 percent reduction in tumors in animals at the preclinical stages. RNA silencing technology is also being explored to counter other cancers by using patented technology. Dr Vijayan is also confident of developing an oral or transdermal route of delivery for insulin using their patented nano lattice technology. â€œI believe that the transdermal route of administration of drugs and vaccines is a very exciting opportunity for us to conduct research. We hope to develop a platform technology to be able to use it for a variety of compounds,â€? he says. Biogenerics is another important area where newer methods are being used by Dr Vijayan. Erythropoetin is produced via adherent cell cultures, which are relatively difficult to scale up to large quantities. With the aid of a new technique, it is now being produced in a suspension cell culture in large fermentors. Dr Vijayan's 'never say die' attitude comes across when he says, â€œI believe in not leaving anything half way.â€? We have faced some roadblocks and will continue to do so, but we always try to explore alternative routes. Our perseverance has paid off so far and we are beginning to make tremendous progress.â€? Manasi Vaidya in Bangalore ]]> <![CDATA[Personalized care in cancer]]> https://biospectrumindia.com/news/95/1571/personalized-care-in-cancer.html https://biospectrumindia.com/news/95/1571/personalized-care-in-cancer.html Mon, 09 Jan 2012 15:03:00 +0530 Dr Pradip Majumder CSO, Mitra Biotech Bangalore-based Mitra Biotech's aim is to be a friend to the lakhs of patients suffering from cancer, much like its name, by helping them receive treatment specific to their individual cancer type. Leading this operation is Dr Pradip Majumder, the chief scientific officer and one of the three co-founders of the company. After his post graduation in pharmacy, he did his doctoral studies on transcriptional regulation of steroid receptors in prostrate cancers. During a brief stint at Tufts University, he was invited by a professor to join his lab at Harvard where he did his post-doctoral research. His experience at Harvard, where he continues to be an adjunct faculty member, helped him learn the intricacies of cancer biology and study its various disease models. He realized the urgent need for an accurate model to replicate a particular cancer, which could be used to predict the course of the cancer and the drugs to successfully eliminate it. Oncomics, the proprietary platform technology for personalized medicine, was initially developed at Harvard and further honed in India. â€œFor example, in bacterial infections, we culture the bacteria and based on the growth pattern the doctor prescribes the necessary antibiotic. In cancer, such a mechanism is not there. From a genetic point-of-view, the same cancer in five different individuals will be different, and there are 50 different drug combinations for breast cancer alone. The selection of the drugs prescribed is random with the success rate of 20 percent in most cancers. A scientific tool was needed to tell which drug will work for which person. The concept was there, we developed the technology,â€? he explains. Their patented explant technology is used to culture an individual patient's tumor sample. Until now, during tumor culture, the serological or pathological conditions of the body were not fully considered. A particular microenvironment is required for the tumor cells to completely mimic the actual tumor cells in the body. The explant technology incorporates the necessary signaling pathways along with other necessary factors, such as ligands and paracrine factors, derived from the patient. â€œThese things help us mimic the patient's body environment and culture tumor cells with drugs available for that type of cancer,â€? says Dr Majumder. â€œSimultaneously, we also carry out in vivo studies in mice, which are implanted with the patient's tumor cells. After the analysis of both of these procedures by the Oncomics platform, we can predict which drug will be most efficacious in treating that particular type of cancer.â€? He says that they found the results from the explant technology matched those of the in vivo studies. â€œThis proved that we could rely on the results from explant technology. Now, we can predict the best treatment option for a patient's cancer in ten days,â€? he adds. Dr Majumder and his team have validated this platform in over 400 patients clinically, with an accuracy of over 90 percent. Mitra Biotech is collaborating with HCG group of hospitals to provide this service to cancer patients. In addition to the tests mentioned, the tumor samples are also subjected to gene profiling and micro RNA analysis. The generated data is being used for developing anti-cancer drugs. â€œWe are in collaboration with pharma companies for three anti-cancer molecules, and are trying to determine which drug molecules and specific combinations can be most effective. We are taking the drug from R&D phase to clinical trials,â€? he says. On future plans, he says that the focus is on different kinds of cancer. â€œCancer research in India presented a unique challenge because very little research has been done on the Indian population. We are focusing on solid cancers prevalent in India. We hope to screen 2,000 patients by 2014 in order to get FDA approvals,â€? he elaborates. ]]> <![CDATA[Ontario onward outward]]> https://biospectrumindia.com/news/95/2293/ontario-onward-outward.html https://biospectrumindia.com/news/95/2293/ontario-onward-outward.html Mon, 09 Jan 2012 14:49:00 +0530 Amongst the various provinces of Canada, Ontario leads on several economic parameters. The data indicates that Ontario has 38 percent of the GDP and 39 percent of the population, personal income and goods exported. As if that was not enough, it also has 43 percent of financial services and 48 percent of ICT employment. Almost an unfair share perhaps. Therefore, it is no surprise that Ontario leads Canada's efforts to go beyond the rather small domestic market and reach inernational shores. In order to accelerate the process, the province has international marketing centers in China, France, Germany, India, Japan, Mexico, UK and the US. The broad focus is on four sectors of manufacturing, health, energy and environment and ICT and digital media. While all sectors are important, the stress could vary from time to time and depending on region. Mr Aaron Rosland, counsellor (Commercial - Ontario), head of the Ontario International Marketing Centre in India, said, â€œIn the past year, advanced medical devices have started to become a focus sector for the India office. Therefore, to lay the groundwork for future activities, we have concentrated on building awareness in India of Ontario's capabilities in this sector.â€? The increased interest in India is for diagnostic, imaging and medical equipment companies in addition to e-health solutions and hospital infrastructure developers. Medical devices is a growing sector in Ontario. There are over 650 companies that focus on diagnostics, imaging, medical treatment, surgery and assistive technologies. The sector employs 22,000 people that are slightly more than what the pharmaceutical and biotech sector employs. In terms of revenue, at $4 billion annually it is expectedly less than the $8.3 billion pharma sector. The government of Ontario has helped in the growth of the sector through various initiatives. 'We look forward to opportunities in emerging markets' In an interview with BioSpectrum, Dr John Rowlands, founding scientific director of the Thunder Bay Regional Research Institute, Ontario, talks about his mammography imaging solution, its commercialization through XLV Diagnostics, and relevance in emerging markets. You have done research in medical imaging for 30 years. How would you describe â€œthenâ€? and â€œnowâ€? from the perspective of technology changes? The greatest change has been the move from analogue to digital in medical imaging devices. Thirty years ago it would've been unthinkable to look at radiography images via computer. Now we're moving at an exponential pace to improve those images. You can instantly see the image, make or manipulate multiple copies, and then send them via email. Your work on PET suggests that it can potentially improve the resolution of PET from 10mm to 1mm. Where will this technology be applied? The first application will be in breast imaging. The path to market is to make prototype systems and evaluate them clinically to see whether they're more accurate than x-ray mammography. XLV uses commercial technology rather than medical technology. Do you see this as a new trend that will catch on with many other medical devices? The use of commercial technology is already pervasive in medical systems. To re-use these devices in medicine is logical. For example, take the use of flat panel displays. Today, they are much different in comparison to the old bulky monitors that couldn't be used in the MR environment. They've now been replaced with something that is much more efficient and much less costly. Is XLV Diagnostics going to license the technology or manufacture the product? It will be a combination. XLV Diagnostics will both license the technology and manufacture the product. Lowering the cost of manufacturing to a third of what a flat panel system costs today is laudable. But if XLV were to license the technology, the objective of low-cost medical imaging to the masses in emerging markets could well remain a research objective. Yes, definitely. If XLV Diagnostics were to license this technology, our goal remains to offer low-cost medical imaging to the masses in emerging markets. It is a key research objective. Any plans to license the technology to local manufacturers in emerging markets to ensure that the product is available at reasonable prices? Yes, this is something we're exploring. In emerging markets, digital imaging devices have to multipurpose. How soon will the XLV technology go beyond mammography? First we are building a prototype of the product. Then, we will be developing it into other applications. HIFU with MRI seems promising. How far are you from a commercial product and do you see a reduction in treatment cost? These systems are already licensed for clinical use for some studies, for example, to treat uterine fibroids. Further improvement of transducers will create a reduction in the treatment time and cost. Our main objective is the bigger picture â€“ what I mean is that we're trying to reduce costs overall healthcare. For example, HIFU may always be an expensive procedure but you're saving because the patient outcomes are better. For example, the patient who has had a HIFU procedure will spend far less time in hospital, far less time off work recovering, and requires far less healthcare human resources. Will research collaboration with institutes in emerging markets help in addressing its requirements better? Any plans in that direction? Yes, we definitely have plans in that direction. We recognize the value in collaborating with research institutes in emerging markets. If we partner with institutions in emerging markets, we can better identify patient needs that exist in other parts of the world. Patients in various countries have many different circumstances, challenges, and issues, which are likely to be very different from those in rural and remote Canada. We look forward to this opportunity to work with institutes in emerging markets. Success through collaboration One such initiative is the creation of The Health Technology Exchange (HTX), which addresses the 'pre-commercial' gap. The HTX was set up two years ago and manages an investment fund for the Ministry of Economic Development and Innovation. In its short period of existence, the HTX has made 15 investments to help companies to move from pure research to translation of work to the commercial space. The investments made are not for equity stake but instead the HTX charges a low interest. Due to the attractiveness of the scheme, the HTX receives plenty of applications leading to a high rejection rate. Ontario Centers of Excellence (OCE) is another government arm that works with the industry to fund research in the universities. It works like R&D matchmaker connecting companies with researchers. With a current annual budget of $35 million, the OCE has various schemes that promote industry-academia collaboration. If the OCE invests a dollar in a research project, it expects the industry to invest double of that to ensure commitment. The OCE even has a scheme where they subsidize the salary of students for two years if they choose to work for a start up company. Toronto's Discovery District is an unique feature of Ontario's life sciences sector. The district is spread over two square kilometers and has nine teaching hospitals, 30 research centers and over 20,000 people working in medical research and care. This is a perfect but rare concentration of life sciences expertise. Located within the district is MaRS Innovation, which is an incubator, that brings life sciences companies under the same roof with public sector researchers and venture capitalists. All the action is not just in the greater Toronto area. There are government-funded R&D centers in various parts of Ontario. One the latest amongst these is the Thunder Bay Regional Research Institute (TBRRI) located in the north-west of the province. The center focuses on research in advanced detection, image guided intervention and biomarker exploration. In three years, a significant achievement of the TBRRI has been the launch of two spin-off medical imaging companies. One of these is Tornado Medical Systems, which has developed a margin assessment machine for breast surgery, and the second is XLV Diagnostics, which is developing a mammography imaging solution. Product focus While many companies are working on bringing products to the market using the technology and research being done in the province, the case of three companies is interesting from different angles. Tornado, the spin-off from the TBRRI, started with an OEM product called Hyper Flux S32 Raman Spectrometer and is now developing its own end user product. In the North American region where the number of breast conservation surgeries (BCS) exceed that of mastectomies, there is also a 20 percent to 40 percent re-excision rate for BCS procedures. Re-excision procedures create trauma for patients and an expense for hospitals as they are not covered by insurance companies. The margin assessment machine (MAM) being developed by Tornado allows the doctors to assess during surgery itself whether all of the malignant tissues have been removed. The Sentinelle division of Hologic has developed an add on device to the regular MRI for breast scanning. Sentinelle was the first to develop a variable coil that is adjustable for breast MRI. The Sentinelle system design allows for better access for targeting in all quadrants of the breast and is compatible to leading biopsy and localization needles. They are now moving into the men's health area with a two channel endo MRI coil for prostate and pelvic imaging. Baylis Medical started as importers and distributors of medical products in 1986. Around a decade back, they developed and shipped their own product. Since then the company's business model has changed from a being a pure distributor to 90 percent of revenues coming from manufacturing. The product lines of Baylis are in the cardiology, radiology and pain management areas. The common technology theme used in the products is radio frequency. The pain management system seeks to destroy problematic nerves that are responsible for pain. The radio frequency puncture system is used to creating controlled perforations in cardiac and vascular tissues. India market India is not amongst the top 10 countries to which Ontario exports to or imports from. Almost 79 percent of goods export is to the US and the Netherlands, ranked tenth, is a mere 0.6 percent. Ontario imports 57 percent of its goods from the US and China comes second at 11 percent. In fact, France and India are the only two countries not in the top 10 despite having Ontario's international marketing centers. India is thus a case of a potential market that is yet to tapped effectively. However, it is not going to be easy with India being a focus for many jurisdictions around the world, because it is full of opportunities for collaboration. â€œWhile we are interested in selling products, we hope to differentiate ourselves by also focusing on the 'how'. The 'how' includes Ontario's collaboration in education and training and that 47 percent of Canada's total R&D happens in Ontario. We also hope to enhance the existing linkages between India and Ontario, which includes a strong diaspora of approximately 7,00,000 Indo-Canadians in Ontario,â€? added Mr Rosland. As many multinationals have realized, sometimes late, there is a market in the metros of India and another large one in the non-metros. The former is lucrative and easier to tap. The latter is potentially a huge market and more difficult to penetrate. Ontario companies seem to be looking at both. According to Mr Rosland, apart from the metro market, there are a number of exporters who recognize the potential market size that is available outside of the metro market, and are frequently visiting India and forging alliances with major hospital chains and exploring opportunities in tier two and three cities. Ontario's initial success story was in the automobiles sector with its lower manufacturing costs and easy access to the large US market. The medical devices sector presents the same easy access but the rest of the dynamics is very different. With medical devices, Ontario has a working collaboration model that involves industry, universities, hospitals and research institutions all working together to grow the sector onward and outward. E Abraham Mathew in Ontario The author was in Ontario, Canada, at the invitation of Ministry of Economic Development and Innovation of the Ontario Government ]]> <![CDATA[2012: The year ahead]]> https://biospectrumindia.com/news/95/1833/2012-the-year-ahead.html https://biospectrumindia.com/news/95/1833/2012-the-year-ahead.html Mon, 09 Jan 2012 12:37:00 +0530 Industry leaders speak about the trends in the biotechnology industry and business expectations for the coming year The global biotech space has seen heightened activity in the biosimilars space with several new partnerships being announced. The growing presence of innovators in pursuit of biosimilars highlights the serious challenges in drug innovation. This will put added pressure on USFDA to relook its regulatory process and also urge the roll out of the long-awaited guidelines for biosimilars. Future trends in innovation are being seen in the area of new drug delivery devices, combination therapies, cancer vaccines and companion diagnostics. Radical cost-cutting in healthcare budgets coupled with escalating drug development costs pose serious challenges. Governments reeling under the financial burden of healthcare are likely to bring down orphan disease allowances which will make it even more challenging. Drug companies will be compelled to focus on cost efficiency and innovation efficiency. Indian companies must take advantage of this new market environment.â€? -Dr Kiran Mazumdar Shaw, CMD, Biocon India The year 2011 was a mixed bag from the perspective of a service provider organization, such as Abexome, that offers bioanalytical services to the biopharmaceutical industry. We saw a slowness in decision-making in many service contracts, and some projects were shelved by our clients. It appeared that some of the new entrants in the biopharmaceutical scenario were at a crossroad whereas the larger organizations consolidated their development pipeline. Development of therapeutic proteins like Erythropoietin or G-CSF was no longer in the pipeline and next generation biologics such as PEG-GCSF, Darbepoetin and the mAbs became more sought after molecules. This year we expect to launch assay kits for many biosimilars. As the experienced biopharma organizations move ahead with their next-generation pipeline, more contracts are expected for service providers like Abexome Biosciences. -Dr Sujan K Dhar, CEO, Abexome Biosciences The industry is poised for tremendous growth in all areas of biotechnology. The news regarding formation of BIRAC with early stage funding schemes and support services is a welcome news and will give much-needed boost to early stage start-ups. India needs to streamline its regulatory approval system both for biopharma and the agri-biotech sector as the growth prospects hinge on the establishment of a clear regulatory landscape. ABLE will work closely with both the industry and the government to facilitate growth of the biotechnology sector.â€? -Dr Satya Dash, COO, Association of Biotech Led Enterprises (ABLE) Biotechnology will continue to make giant strides in offering succor to the needy by developing newer recombinant drugs, vaccines and innovative alternate therapies with stem cells. Need for innovative solutions in healthcare will continue to fuel further developments and let India lead from the front. Innovative alternates are emerging in the field of stem cell therapies, and with continued support and guidelines from the government and strict implementation of the regulatory policies, we can look forward for novel therapeutic offerings from cellular therapies. -Dr Ramananda Nadig, CEO, Khoday Stemcell Research & Medical Center Anthem Biosciences had a very successful 2011. Our business grew nicely and profitably. But the creases on our brow never eased throughout the year, because of the extreme volatility in the global markets, and the dismal domestic situation. To make far-reaching plans and have reliable forecasts, industry needs stability. The situation doesn't look better as we welcome the new year. It appears we are in store for more volatility globally and inertia from our government planners. Anthem, however, is committed to investing further and trying to expand its geographical spread of business. -Mr Ajay Bharadwaj, CEO, Anthem Biosciences The year 2011 was tough for the CRO industry in India. It became unattractive due to regulatory uncertainty. Indian CROs having a strong backlog survived. Those with operations outside India managed to keep their head above water. Market in India saw negative growth. Overcapacity has forced investors in CRO space to look for exit. Silver lining for 2012 is that inspections by the DCGI and FDA in most cases confirmed GCP and GLP compliance, showing confidence in quality. Scaling to $50 million revenue, differentiating through unique competency, diversifying country risk are areas Indian CROs will have to work for to survive 2012.â€? -Mr D A Prasanna, chairman and MD, Ecron Acunova Self-regulated environment with important checkpoints and balances will help in building this industry. It is the responsibility of professional societies, medical professionals, industry bodies, government and regulatory bodies to work in tandem to build confidence in society. Research is important for this country and outcomes define treatments, and it should be our responsibility to foster this path for disease and drug innovations.â€? -Dr Krathish Bopanna, president & executive director, Semler Research With low-cost manufacturing capabilities and strengths in small molecule generics Indian companies are well positioned to benefit from the estimated 48 biologics that are slated to go off patent in the next decade. Indian market could become preferred destination for clinical trials because of cost advantages, availability of patient population, GCP-trained investigators and quicker recruitment. Regulators may strengthen systems and processes to ensure quicker approval of studies and more robust monitoring of clinical trials. Both industry and regulators need to make efforts to educate the media and society on conducting of clinical trials and bioequivalence studies and regulations.â€? -Mr Anil Panwar, CEO, Fortis Clinical Research We had a great year of business in genomics space with growth in agribio and clinical genomics segments. For 2012, Premas' life sciences division is expecting to continue its growth of Illumina business along with establishing its newly launched products from Trinean, ACDBIO, Biomatrica and many more. We are hoping that the 12th five-year funds are released well in time to enable initiation of new projects. We are also hoping for adoption of NGS by the clinical segment.â€? -Mr Praveen Gupta, executive director, Premas Biotech I see 2012 as a year where general bioinformatics will further get segmented into sub-categories, such as text-mining, tool development and micro-array services, and winners will emerge in each category. Companies will move up the value chain offering higher-end services like systems biology to its customers.â€? -Mr Jignesh Bhate, CEO, Molecular Connections We are always optimistic at ReaMetrix about the prospects of biotechnology. In 2011 we laid the foundation for potentially changing the way medical diagnostics can be practiced through the development of a unique lab-in-a-box. We are happy with the initial feedback and we believe that the impact of this platform will go beyond the area of diagnostics and have an effect on other areas of life sciences as well. We expect to see the results of our work begin to bear fruits in 2012 and make an impact in the global arena. We hope to see more such path breaking innovations in 2012 from our community.â€? -Dr Sridhar Ramanathan, executive director, operations, ReaMetrix The year 2011, although good for the vaccine industry in terms of rise in demand, also witnessed increased competition with entry of more players and regulatory trouble for some players. The year 2012 can be expected to be better with hepatitis B vaccine now fully in the UIP program and pentavalent vaccine taken up by some states, besides increased scope for animal vaccines in disease control programs.â€? Mr K V Balasubramaniam, MD, Indian Immunologicals The Biotech industry continued to see strong growth in 2011 on the strength of biopharmaceuticals, growing markets, several new biosimilar product launches in India, exports of biosimilars and product-based partnerships. This trend is expected to continue in the year 2012. The industry has had to face several challenges in 2011, particularly with price erosion, greater competition, constraints in capital markets, currency depreciation and more stringent regulations for biotherapeutics. The industry will continue to face these challenges in 2012. The biotech industry has the potential to grow at 20-to-25 percent per annum. This is contingent on a partnership between the industry and the government. -Mr K V Subramaniam, president and CEO, Reliance Life Sciences The year 2011 has been exciting with the international markets beginning to appreciate technologies developed in India. Efforts by the government through agencies like DST and ABLE have been commendable. To further boost the industry, import duty benefits in any shape or form will be of great help for equipments and raw materials irrespective of EOU status, as Indian consumption is growing steadily and there is a need to propel technology innovation and make it affordable for the domestic market. Biotech policies should be aimed at promoting manufacturing along with R&D and need to be aligned with the implementation of National Manufacturing Policy released in November 2011. -Dr Subramani Ramachandrappa, chairman & managing director, Richore Lifesciences In 2011, we acquired our own American company and started a new journey towards becoming an Indian multinational. The year 2012 is expected to be another major milestone year for us. We are expecting to start our European company. We are also expecting to commission our state-of-the-art and South East Asia's biggest enzyme manufacturing plant. We also are expecting the biggest jump in our net income and in our global sales. Several cooperation and collaborations are also expected in 2012 in almost all aspects of the business.â€? -Mr C L Rathi, MD, Advanced Enzymes Technologies The year 2011 was a mixed bag for the agricultural biotechnology industry. The area under Bt cotton continued to increase resulting in a record production of almost 35 million bales. But there has been a virtual stand-still on the regulatory front. GM crop technology testing was considerably hampered by the new requirement of No Objection Certificate from the state governments. The BRAI Bill is still hanging fire. I hope that 2012 will see the removal of some of these needless regulatory hurdles paving way for the introduction of some of the much-needed technologies in Indian agriculture.â€? -Dr K K Narayanan, MD, Metahelix Life Sciences The new year 2012 is likely to see a slowdown given the uncertainty in Europe. So it will not be a boom time but it will neither be doom time. The research work by its nature is a continuing activity and those who have raised money timely or have cash surplus will not be affected, but others may hold some of their research projects as raising funds would be a challenge. Even for the PE funds, this is a challenging time. On demand side, I do not see this slow-down affecting too much as valuable intellectual property is always desired. The up fronts in licensing deals may however come down but as a result, overall deal sizes may get bigger with larger back-ended paypacket. -Supreet Deshpande, CEO, VLife Sciences Biotech industry in 2012 will see a surge in the use of new technology and renewed focus on regulatory affairs in the clinical arena. A lot of people, especially those who have deep pockets, will adopt new technological solutions to the old problems. The main challenges, however, will be translating the innovation in the services sector of bioinformatics and allied services into solutions and products. The winners will be the ones that possess both deep scientific knowledgeable and develop an understanding of applications of genomics to solve various societal pain. -Mr Binay Panda, CEO, Ganit Labs ]]> <![CDATA[Industry seeks more incentives]]> https://biospectrumindia.com/news/95/2291/industry-seeks-more-incentives.html https://biospectrumindia.com/news/95/2291/industry-seeks-more-incentives.html Mon, 09 Jan 2012 12:35:00 +0530 Biotechnology industry has a strategic role to play in addressing various developmental challenges of the nation, be it in healthcare in terms of affordable medicines and therapies and delivery models or meeting the challenges of food and energy security. The Biospectrum-ABLE industry survey of 2010-2011 showed that the revenue of biotechnology industry in India touched 15,000 crore despite the global downturn in 2009 and slow recovery in 2010. The industry has grown consistently in double digits over the last decade with average revenue growth figure above 20 percent. It is estimated to reach a turnover of around 45,000 crores by 2015 which would require it to grow at about 30 percent year-on-year. To achieve this target a synergistic support from the central and state governments is needed. BioSpectrum asked industry associations - ABLE, ACRO, VMA, CII, FICCI, ADMI - about their recommendations to the Union Finance Ministry for Budget 2012. Read on to know the steps these associations have recommended to the government to boost the growth of the biotechnology industry in India. â€¢ Invest more in innovation venture funds â€¢ Sanction funds for training cell â€¢ Remove import duty on consumables â€¢ Weighted tax exemption on R&D â€¢ Allocate funds for cGMP facilities â€¢ Exemption on materials for test kits ]]> <![CDATA[Exemption on materials for test kits]]> https://biospectrumindia.com/news/95/6851/exemption-on-materials-for-test-kits.html https://biospectrumindia.com/news/95/6851/exemption-on-materials-for-test-kits.html Mon, 09 Jan 2012 12:32:00 +0530 Association of Diagnostic Manufacturers of India (ADMI) provides a platform for the Indian IVD manufacturers to voice their concerns and resolve issues. It has 27 members, which includes 21 manufacturers and six distributors and suppliers. It recommends Exemption for antigens & antibodies in test kits Under general exemption No. 122 (Notification No. 21/2002) at Sr. No. 83, which covers chapter 28, 29, 30 & 38, the following goods, namely life-saving drugs or medicines, including their salts and esters, bulk drugs used in the manufacturing of life saving drugs and diagnostic test kits are specified in List 4. For import of raw materials such as antigens or antibodies or any other ingredient corresponding to the manufacture of diagnostic test kits specified in List 4, benefit of duty exemption permitted for bulk drugs for manufacture of drugs or medicine is not extended since the words â€œdiagnostic test kitâ€? do not specify them. The import of raw materials such as antigens or antibodies or any other ingredient corresponding to the manufacture of diagnostic test kits specified in List 4, therefore, puts the local manufacturer at a disadvantage in comparison to those importing finished diagnostic test kits as diagnostic test kit is specified in List 4. The notification should, therefore, include the following: bulk drugs, antigens, antibodies (monoclonal/polyclonal), raw materials, components used in manufacture of life saving drugs, medicines including their salts and esters and diagnostic test kits. The import of certain diagnostic kits were covered under exemption No. 122 Sr. No. 363 and is part of List 37. The following items, which were a part of the now abolished List 37, need to be included in List 4 to allow for a level playing field for both Indian manufacturers and importers. Exemptions for ELISA kits components Under the general exemption No. 122 at Sr. No. 95, various components for manufacturing ELISA kits have been allowed the benefit of lower duty. This list may be extended to include antigen or antibody on the solid phase for coating. The other key component is the enzyme conjugate and their stabilizing buffer and solutions. These key ingredients have not been covered by the current list, hence it needs to be enhanced and corrected to put the local ELISA kit manufacturer at par with the importer because all finished ELISA kits are imported at nil duty as per item No. 36 on List 4. Specific suggestions on duty rationalization With abolishing of List 37, all diagnostic devices are now covered under Chapter 90 (9027) customs unless they are part of General Exemption No.107, Sr.No.83, List 4. They, therefore, attract high duty rates, and it is recommended that they be classified under 9018 or nil duty to encourage access to newer technologies. Further, duty on manufacture or import of diagnostic reagents should be reduced to encourage manufacturing in India. The following need to be rationalized: Excise duty for manufacturing of diagnostics reagents may be made nil from existing 10 percent. Diagnostics reagents may be treated same as medical equipment under Sec 9018 from existing 26.75 percent Duty on PCR kits may be made nil from existing 26.75 percent as is the case for ELISA and CLIA diagnostics kits. All diagnostics equipment, including fully automated biochemical analyzers, may be assessed at nil duty or with a total duty of 9.63 percent as imposing of a duty of 14.72 percent will raise the cost of these hi-tech instruments significantly. Customs tariff for diagnostics kits may be based on criticality of the test rather than the technology. Second-hand laboratory and medical equipment should have a penal duty to disincentivize their import and sales in the country. To encourage local manufacturers, I feel the following provisions may be given across the board, be it reagents, instrumentation, plastics and metal. Import duty should be there for all end products. CVD and excise may be exempted. Manufacturer should able to import raw materials duty free. Mr Deepak Trivedi president, ADMI, & MD, Tulip Group ]]> <![CDATA[Allocate funds for cGMP facilities]]> https://biospectrumindia.com/news/95/1815/allocate-funds-for-cgmp-facilities.html https://biospectrumindia.com/news/95/1815/allocate-funds-for-cgmp-facilities.html Mon, 09 Jan 2012 12:30:00 +0530 Vaccine Manufacturers Association (VMA) brings together India's top vaccine producers Bharat Biotech, Biological E, Panacea Biotech, Serum Institute and Veterinary Biological and Research Institute, Hyderabad, on one platform. The following are the recommendations of the VMA: Allocation of funds for the following activities and programs under the Ministry of Health and Family Welfare, Government of India: For strengthening of Universal Immunization Programme to ensure proper coverage of all the target population of infants, children, pregnant mothers, for higher percentage of immunization. For the introduction of adult vaccines in rural areas and among the urban poor. For imparting intensive training to a higher number of vaccine administrators in order to reduce adverse events while administering vaccines and to assist in timely reporting of adverse events. For the promotion of neglected vaccines such as vaccine against typhoid fever. For supporting studies on the enumeration and estimation of the disease burden of infectious and communicable diseases in India. For strengthening of the Central Drugs Laboratory (CDL), Kasauli, and establishment of the CDL in Hyderabad for South India. To gather accurate consolidated data on the number of units manufacturing vaccines and other biotech products and for listing the products. Allocation of funds on soft loan basis to the vaccine industry for continued maintenance of cGMP at their facilities and for expansion of capacities. Huge proportion of vaccines are supplied to the Government of India and to the states at lower rates and the industry finds it difficult to purchase new equipment as replacements. Allocation of funds to the Department of Biotechnology, Department of Science and Industrial Research under the Ministry of Science and Technology: For extending funds for discovery of new molecules in biologics. For funding clinical trials of vaccines in other developing countries by vaccine manufacturers. For establishing training centers to train workforce for vaccine and biotech production and testing. For release of funds to the departments to assist vaccine manufacturers to attend international conferences organized by selected organizations. Special reduction in excise duty, sales tax and value added tax for vaccines that are, in general, given to infants, children and mothers for the prevention of specific infectious diseases and, therefore, for better health. Vaccines, in fact, are life- saving interventions. Research and development incentive provisionsSECTION 35 (2AB)- Scientific research: Issue of concern Increase the quantum to encourage more participation since the incentives are inadequate for risky investment coupled with long gestation periods involving complex business environ Recognizing Limited Liability Partnership as an entity eligible The existing provisions of the Income-tax Act allow weighted deduction of expenditure incurred for R&D activities. To provide further boost, the weighted deduction in case of in-house R&D expenditure incurred by companies engaged in the business manufacture and production of articles and things. The weighted deduction should be increased to 250 percent from the existing 200 percent. Weighted deduction is available for companies engaged in manufacture and production of articles and things or engaged in biotechnology. The deduction was introduced to enhance indigenous research. This was given further impetus by increasing the deduction to 200 percent. However, the deduction is expiring by March 31, 2012. Extension of this provision beyond March 31, 2012, is suggested. Further, the contribution based deductions for R&D should also be increased as under: In order to facilitate holistic and pervasive development of R&D activity in the country, it is imperative to promote innovation not only in pharmaceutical, auto or agriculture industries through benefit of enhanced deduction on account of R&D but also cover other equally important industries like information technology, biotechnology, among others. Clinical trial expenditure is aimed to secure confirmation about the suitability and efficacy of a proposed drug on a particular set of living beings. The clinical testing is under regulatory mechanism of the Drugs and Cosmetics Act. As per this Act, a clinical trial is required to be undertaken only by organizations approved under the Drugs and Cosmetics Act. An in-house research is not permissible under Drugs and Cosmetics Act. Sec 35(2AB) of the Income Tax Act, stipulates to provide relief of weighted deduction, if and only when expenditure is incurred on in-house research, while the regulatory law does not permit in house research mechanism for clinical trials. The scientific research is incomplete and does not get recognition unless clinical trials are concluded as per regulatory requirement under Drugs and Cosmetics Act. Thus, the stipulation under the Income Tax Act, 1961, fails to recognize certain key element of scientific research expenditure for granting weighted deduction purely for reasons that it is not in-house. We recommend a suitable provision for recognizing clinical trials as part of scientific research for weighted deduction. The recommended areas for granting weighted deduction in respect expenditure which are at present ignored for consideration, under pretext that it is not an in-house expenditure are: Expenditure on clinical drug trial, carried under a recognized entity by the Drugs and Cosmetics Act Expenditure training approval from any regulatory authority under any central, state or provincial Act and filing an application for a patent. Pharmaceutical companies claim clinical trial expenditure as eligible for weighted deduction for these reasons: Clinical trial expenditure is incurred as an extension to the in-house research of the company. Clinical trial expenditure is incurred on in-house research and the tax law stipulates that the expenditure be incurred in in-house research of a company and hence expenditure incurred on in-house research is eligible. However, tax authorities interpret that the clinical trial must be conducted in-house to claim the expenditure as eligible for weighted deduction. Clarificatory amendment is sought specifying that clinical trial expenditure incurred in relation to the drugs developed by the company should be eligible for weighted deduction irrespective of the fact whether clinical trial is undertaken in-house or is outsourced. ]]> <![CDATA[Weighted tax exemption on R&D]]> https://biospectrumindia.com/news/95/2950/weighted-tax-exemption-on-rd.html https://biospectrumindia.com/news/95/2950/weighted-tax-exemption-on-rd.html Mon, 09 Jan 2012 12:28:00 +0530 The Biotechnology Sub-Committee of the Confederation of Indian Industry (CII) has over 40 members from all verticals of biotechnology, including small and medium-sized enterprises and multinational corporations in vaccine, agri and biopharma industry Access to funds and tax exemptions for R&D: The biotech industry should have access to cheaper funds with long repayment terms for R&D investments. The government must create a budget through which 50 percent of the total income tax paid by a company in the last 10 years can be paid back as loan to an R&D organization for 20 years at two percent annual interest. The weighted tax exemption of 200 percent on R&D expenses should be continued for at least the next five (preferably 10) years. This will help R&D-oriented companies to take long-term strategic decisions on R&D projects. It will also act as a booster for further investment in R&D. Extension of time limit for investment and tax exemption period at notified areas for biotech industry: The current time limit for investment at the notified areas for biotech industry is expiring on 31st March 2012. It should be extended by another 10 years and since the gestation period is very long in biotech industry, therefore a 100 percent tax exemption should be allowed for initial 10 years. R&D programs should be encouraged, and hospitals need to be included in R&D programs of Government of India apart from that of universities and the industry. It will help academic institutions (as it will give access to market relevant research, R&D processes and product delivery focus) and the industry (as it will give access to human resource ensuring continuity, bright minds essential for innovation and unfulfilled needs for doctors and patients) Inclusion of outhouse clincal trials for weighted tax exemption: At present, 200 percent tax exemption is allowed on revenue and capital expenses incurred by approved R&D centers on in-house projects. Clinical trials conducted through CROs are not eligible for 200 percent weighted tax deduction, nor even 100 percent. Since clinical trials conducted through CROs are important and are an integral part of overall R&D programs and account for two-third of R&D cost, weighted tax exemption of 200 percent should be allowed on all clinical trials irrespective of whether conducted in-house or through CROs. This will ensure the goal of Government of India to make drugs affordable. Multiple Research Project Funding: Currently, the research grants or funding are generally allowed for up to two projects per company. There should be no limit to the number of projects or it should be applicable on each R&D center recognized by the DSIR instead of keeping it per company. Waiving off sales tax and excise on all pediatric products: The government should consider exempting all products which are specifically used for pediatric purposes (for all children up to the age of 12 years) from sales tax and excise duty. Extend scope of life-saving medicines and exempt them from sales tax/excise/custom duty: The government should considering extending the scope of life saving medicines and also exempt these medicines from sales tax/excise/custom duty. This will help make critical medicines affordable to end users. Dr Rajesh Jain, chairman, Biotechnology Sub-Committee, CII, & JMD, Panacea Biotec ]]> <![CDATA[Remove import duty on consumables]]> https://biospectrumindia.com/news/95/7328/remove-import-duty-on-consumables.html https://biospectrumindia.com/news/95/7328/remove-import-duty-on-consumables.html Mon, 09 Jan 2012 12:19:00 +0530 The biotech division of the Federation of Indian Chambers of Commerce and Industry (FICCI), an association of business organizations in India, recommends the following: To promote the development of large-scale monoclonal antibodies (mAb) facilities (a scale equal to or more than 5,000 liters) Around 30 percent duty on imported equipment should be eliminated for a period of five-to-10 years in order to allow companies to build large-scale manufacturing plants like continuous centrifuges and control systems of large-scale cell culture bioreactors, among others. Import duty on critical consumables, such as filters, flow and level measurement devices, should be eliminated for a period of five-to-10 years, so that the industry gets promoted like R&D. Large biotech plants may be supported with long-term soft loans with low interest rates (three percent) and with a moratorium of around three years. All expenditure related to research carried out in the in-house facility, including clinical trials, bioequivalence studies, regulatory and patent approvals should be eligible for weighted deduction, even if these activities are carried outside the approved R&D facility, including overseas expenditure. Government must create a budget through which 50 percent of the total income tax paid by a company in the last 10 years can be paid back, or at least as loan to an R&D organization for 20 years at a nominal rate of interest. The percentage of weighted deduction on contributions made to an exclusive R&D company for carrying out research and development should be increased from 125 percent to 175 percent. In relation to testing or analysis of newly developed drugs or devices, including vaccine and herbal remedies as well as central laboratory services, data management, biostatistical analysis and reporting services for clinical trials pertaining to drugs or devices, on human participants to ascertain the safety and efficacy of such drugs on human beings be exempt from the whole of the service tax leviable thereon under Section 66 of the said Finance Act. ]]> <![CDATA[Sanction funds for training cell]]> https://biospectrumindia.com/news/95/7094/sanction-funds-for-training-cell.html https://biospectrumindia.com/news/95/7094/sanction-funds-for-training-cell.html Mon, 09 Jan 2012 12:17:00 +0530 Association of Contract Research Organizations (ACRO) is an independent, non-profit organization with a global perspective and has 23 companies as members. It recommends the following reforms urgently: 1) For any study approval, CROs need to undergo a tiresome array of processes and paperwork. Single-window clearance from the office of Drug Controller General of India would be efficient, effective and timely. This would prevent undue red tape and bureaucratic hassles. 2) The government should sanction funds to establish a cell to conduct training sessions across India to spread awareness on the benefits of conducting ethical clinical research. Doctors, clinicians, ethics committee members and other stakeholders would benefit from such sessions. The cell would also be responsible for regular updates of ethics committee's resolutions and audits of the CROs to grade their expertise and ensure compliance. These twin measures would permit timely approvals, shorten the time-to-market for drugs by reducing time and cost overruns, and thereby facilitate the government's efforts to ensure lower drug prices. Since clinical research is imperative and indispensable to enhance the quality of life for patients, ACRO India believes the above reforms will go a long way in making the lives of patients more comfortable. Mr Apurva Shah chairman, ACRO, & MD, Veeda Clinical Research ]]> <![CDATA[Invest more in innovation venture funds]]> https://biospectrumindia.com/news/95/2154/invest-more-in-innovation-venture-funds.html https://biospectrumindia.com/news/95/2154/invest-more-in-innovation-venture-funds.html Mon, 09 Jan 2012 12:09:00 +0530 Association of Biotechnology Led Enterprises (ABLE) is a not-for-profit national forum that represents the Indian Biotechnology Sector. With more than 200 members from across India, ABLE catalyzes a symbiotic interface among the industry, government, academic and research institutes and domestic and international investors 1. Innovation fund Government of India (GOI) should invest more money in setting up venture funds especially to support all companies that support innovation in India, be it foreign-owned or locally-owned. It should also encourage innovation by providing seed funding to help indigenous biopharmaceutical companies license new technologies and intellectual property from other countries and build on them. Such funding can take the form of mixed grants and loans, with repayment of the loan element contingent on success. The existing funding programs provide support to the companies that have products in the late stage of development, but there is a crippling paucity of risk capital for early stage innovation. Moreover, assuming that such innovation will only be performed at academic institutes is too restrictive an approach. Start-up biotechnology companies can be effectively groomed to conduct directed research. 2. Export tax incentives Export promotion in this sector should remain one of the top priorities. Tax incentives were available on exports made by STPs (Section 10B) till March 2011. These were withdrawn from assessment year 2012-13. To encourage exports in this sector considering the economic scenario, this tax benefit should be restored in the next Budget. 3. Tax incentives for research activities 3.1 As per the current tax incentives, 200 percent weighted deduction is available to those firms that are engaged in manufacturing or production. There is a sunset clause prescribed for availability of this incentive for expenditure incurred up to March 31, 2012. The uncertainty associated with outcome of research & development (R&D) makes it a challenging task, especially where investments are high and anticipated return is low. Investments in R&D may not always fetch a high return immediately. Withdrawing the benefit of 200 percent weighted deduction may prove to be a dampener to most industry players undertaking or proposing to undertake research & development in India. In order to provide an impetus to R&D growth, the benefits of the weighted deduction should be continued beyond March 31, 2012. 3.2 The rate of weighted deduction should be increased from a present rate of 200 percent to 300 percent, considering the long gestation period to break-even and R&D incentives offered by other countries. 3.3 The contract research organisations (CROs) are not included in this scheme. The CROs in India are increasingly focusing on leveraging their in house potential to do R&D. Hence to promote long-term growth of India as a R&D hub, this scheme should also be extended to include the CROs. Apart from this, there is also a need to introduce benefits in the form of research tax credits to promote India as an R&D hub. 3.4 Weighted deduction should be provided for certain activities like outsourced clinical trials and R&D, preparations of dossiers, foreign consulting or legal fees for new chemicals entities and abbreviated new drug applications filings with the US FDA patent defending charges. This would facilitate companies to outsource part of research activity for cost efficiencies. 3.5 Exemption of 100 percent profits of companies engaged in scientific R&D for a period of 10 consecutive assessment years should be extended for the companies obtaining approval till March 2013. Currently, this benefit is available only if company was approved by prescribed authority before April 1, 2007. 4. Recommendations pertaining to minimal alternate tax (MAT) and service tax provisions 4.1 Lot of sector specific special economic zones (SEZs) have come up and biotech SEZs are one of them. The SEZ benefit is almost removed by extending the coverage of MAT from April 1, 2012. By this the total tax benefit of SEZ is withdrawn. Weighted deduction (for R&D activities in case it is restored) should be allowed while computing the MAT liability as the current rate of MAT (18.5percent) remains very high. The SEZ and biotech units are huge capital assets oriented, and normally they have depreciation benefit for the initial period of five to 10 years. Applicability of this section practically makes the companies claiming tax incentives (under Section, 80-IC, etc) as a tax payer. Keeping this in mind these companies should be exempted from MAT that facilitates them to continue to retain their cost advantage and thereby help gain higher share in the global research business. Especially, last year, the finance minister left companies in SEZs grumbling as they were brought within the minimum alternate tax net. This has made SEZ investment unattractive. The upcoming Budget should abolish MAT on such companies. 4.2Service tax provisions Service tax on any activity directly or indirectly relating to clinical trials as well as R&D should be exempted. 5. Conversion to Limited Liability Partnership 5.1 Limited Liability Partnership (LLP) promises to be an excellent form of business organization as it provides manifold benefits in the form of minimal legal and procedural requirements to operate, tax benefits and simplicity in setting up, maintenance and wind-up, to name a few. 5.2 Presently, conversion of a company into an LLP is exempted from capital gains tax, provided the totals sales turnover or gross receipts in the business of the company in any of the three previous years preceding the previous year in which the conversion takes place does not exceed Rs 60 lakh . Given the importance of the LLP model and the thrust of the government to promote the same, prescribing such a small limit of up to 60 lakh would certainly be a great deterrent for large pharma companies proposing to move to an LLP mode. Hence, this condition of limit of Rs 60 lakh needs to be removed. 6. Section 115A â€“ Royalty and fees for technical service payments 6.1 Indian companies are required to make royalty and fees for technical services payment to non-residents. Currently Section 115A provides for a concessional rate of tax for income in respect of royalty or FTS received by a foreign company from an Indian concern and where the agreement between the foreign company and the Indian concern is in accordance with the industrial policy. There is ambiguity in the term â€œin accordance with the industrial policyâ€?. Clarification is needed in the ensuing Budget that payments permitted by Reserve Bank of India under the Current Exchange Control Regulations should be regarded as covered within the industrial policy. 7. Mergers and acquisitions 7.1 In the current economic environment that the world is going through, restructuring of business (merger, de-mergers, acquisitions) plays an important role. In this context, following amendments should be brought about in the upcoming Budget: • There are stringent conditions prescribed for availing the benefit of carry forward and set-off of loss amalgamating company to the amalgamated company. The same does not remain relevant in current scenario and accordingly the same should be modified. • The benefit of carry forward and set-off of loss is currently restricted to specified business. The same should be extended to all sectors, especially service sector, which currently cannot avail the benefits. 8. Section 206AA â€“ Withholding tax compliance 8.1 The implementation of Section 206AA has resulted in additional compliance burden and also increase in cash outflow for Indian players in net of tax situations where the tax on such payments is borne by them merely because the non-resident has not furnished his PAN. To avoid undue hardship to such Indian players, this clause should be removed in the coming Budget. 9. Extension of 100 percent tax-free status for biotech and pharma SEZs 9.1 This status for biotech SEZs should be increased from five to 10 years because of the regulatory gestation. 10. Transfer pricing issue 10.1 Transfer pricing issue relating to the comparison between companies engaged in clinical trial support services with CRO companies needs to be addressed. An Indian company that provides a low-end clinical trial related support services should not be compared with full-fledged CROs for transfer pricing purposes. Safe harbor mark-up percentage should be prescribed for contract research and development services. 11. Other recommendations: 11.1 Agriculture sector: With growing population, the country faces an immediate challenge in food security. The productivity in the agriculture sector has not increased to meet the growing demands on food production. Agri-biotechnology provides immense opportunity to meet the existing challenges in this sector. Further reforms in agricultural education, including making the farmers and the general public understand the new developments in agri-biotechnology as well as appreciate immense potential of this sector, is urgently needed. Funds of around 100 crore should be allotted for the educational reforms as well as general dissemination of the strengths and weaknesses of modern agri-biotechnology. 11.2 Duty exemption norms is required for raw materials imported for indigenous manufacture of life saving drugs and diagnostics. There exists a serious anomaly with respect to imported and indigenous life-saving drugs and diagnostics and wherein raw materials and components used by indigenous manufacturers for such products are levied customs duty and excise duty whereas the finished products are allowed to be imported duty free. This is detrimental to indigenous manufacturing and instead encourages trading. Furthermore, it puts indigenous manufacturers at an unfair disadvantage to MNC competition. It is, therefore, recommended that components and raw materials used by indigenous manufacturers for the production of diagnostics and life-saving drugs be exempted from excise and customs duty based on standard input or output norms certified by the Department of Biotechnology or alternatively duty paid on components and raw materials used in manufacturing of life-saving drugs be eligible for refund. 11.3 Recognition of anti-cancer drugs as life-saving drugs: The cost of cancer treatment in India is very high. Newer anti-cancer drugs like monoclonal antibodies are increasingly being used to treat various forms of aggressive cancers like lung, breast, bladder, esophagus and stomach, head & neck, prostate and ovarian. Anti-cancer drugs form a substantial cost of the treatment of cancer patients. The impact of customs duty at the rate of 10 percent, excise/ CVD at 10.3 percent, education cess at two percent, secondary and higher education cess at one percent and additional duty on customs at four percent would result in a 26.85 percent increase in the price of the drugs, thereby increasing the cost of treatment substantially. Anti-cancer drugs are life-saving drugs and it is imperative that they are exempted of all taxes and duties. It is requested that an exemption from customs duty on the import of anti-cancer drugs and from excise duty on the manufacture of the drug, be granted, by including such anti-cancer drugs under List 4 of Item 83 of the customs notification No 21/2002 dated March 1, 2002, and under List 3 of Item No 54 of the excise tariff notification No. 4/2006, dated March 1, 2006. 11.4 Duty exemption on diagnostic kits for infectious diseases: Diagnostic kits used for detection of HIV antibodies and for detection of hepatitis B antigen are exempted from customs duty under List 4 of Item 83 of the Customs Notification 21/2002 dated March 1, 2001. It is recommended that diagnostic kits for other infectious diseases, such as hepatitis C, malaria and tuberculosis, are also exempted from customs duty. Further, List 3 of Item no 47 and 55 of the Excise Notification No 4/2006 dated March 1, 2006, exempts diagnostic kits specified in lists 3 and 4 and also diagnostic kits for all types of hepatitis from excise duty as it falls within the category of life-saving drugs. It is recommended that diagnostic kits for other infectious diseases be exempted from excise duty. 11.5 Excise duty exemption on molecular diagnostics for critical infections: Critical infections are defined as those which result in death or loss of function in a patient within 96 hours after the onset of illness. Examples are brain and eye infections and septicemia where blindness or paralysis or loss of life will occur quickly. As of now, only molecular diagnostics such as polymerase chain reaction (PCR) and DNA microchips can provide answers for quick and accurate diagnosis. Since the patent on PCR has now expired there is a scope of making many generic PCR-based diagnostics in India and also export them, apart from development of some revolutionary diagnostics. However, these are excisable items and abolishing the duty will give price advantage for exports and the price relief for the Indian patients. 11.6 Establish biotechnology finishing schools and exchange programs for biotechnology: Like any other knowledge-based industry, the biotech industry also requires â€œindustry readyâ€? workforce. ABLE recommends that the government should implement the concept of â€œbiotechnology finishing schoolsâ€? in nationally important departments across India. Emphasis should be given on â€œhands-on-trainingâ€? to students in industrially relevant areas, including work experience in GLP and GMP laboratories. Further emphasis should also be given to data analysis courses as well as to the development of communication skills, both written and verbal. The ongoing pilot experiment in Karnataka with these finishing schools suggests that a fund of 100 crore may be required to initiate such a scheme at the national level. Other recommendations include the following: 11.7VAT/CST • The levy of CST hampers free trade between states. We would like to propose a reduction in the CST rate from two percent to one percent in the Budget for FY 2011-12. • It has been observed that the procedure for obtaining CST declarations in most states is very cumbersome. On behalf of the Indian industry, we would like to propose simplified procedures for obtaining CST declarations. 11.8Excise duty • Rate of central excise duty on pharmaceuticals formulations be continued at four percent. • The generic excise duty rate on the inputs (active pharmaceutical ingredients or APIs) presently is 10.3 percent, whereas the generic excise duty rate on finished formulations is 4.12 percent. Traditionally, in the pharma industry, the excise duty rate on inputs has always been higher than the excise duty rate applicable to the finished products. This has led to an accumulation of Cenvat Credit in the books of the manufacturer, with the inability to utilize it efficiently. It is thus expected that the government either align the excise duty rates of APIs with that of the finished formulations or provide for a refund mechanism for the underutilized Cenvat Credit. • All excisable goods used for R&D purposes to be exempted from excise duty. • Increase in rate of abatement on medicaments from current 35 percent to 45 percent-to-50 percent to cover the trade margins and the value of R&D costs and other costs associated with the pharma industry such as distribution of many medicines through cold chain (for example, vaccines). 11.9Customs duty • Presently, different medical devices have partial exemption under various entries in different notifications. Classification of different medical devices to bring more clarity or reduce dispute from classification aspect should be rationalized. Dr Vijay Chandru president, ABLE ]]> <![CDATA[Will Indian CRAMS lose to competition?]]> https://biospectrumindia.com/news/95/5910/will-indian-crams-lose-to-competition.html https://biospectrumindia.com/news/95/5910/will-indian-crams-lose-to-competition.html Mon, 09 Jan 2012 12:04:00 +0530 Despite the numerous hassles in its path, the Indian contract research and manufacturing services (CRAMS) market has retained its growth. However, with increased competition from other countries, industry veterans are keeping fingers crossed for the future The surge in demand for contract research and manufacturing from international clients, who have invested in the emerging markets through outsourcing, has resulted in the gradual increase in the number of Indian contract research and manufacturing services (CRAMS) companies. As per the Confederation of Indian Industry (CII), the estimated market share of the CRAMS market is around 19,950 crore ($3.8 billion) out of the 350,075 crore ($67 billion) global market. India contributes significantly to serve the entire spectrum of the value chain, covering basic research, pre-clinical, clinical services to active pharmaceutical ingredient (API), formulations and generics manufacturing services. Estimates say that about 20 percent of spending in R&D is outsourced to cut cost. The Indian contract research market estimated to be 7,837 crore ($1.5 billion) is dominated by clinical research organisations followed by preclinical and discovery research. Contract manufacturing worth about 12,017 crore ($2.3 billion) dominates the Indian CRAMS business capturing 60 percent of the market in India. With the business slated to grow further to reach from 36,575 crore to 41,800 crore ($7-8 billion) by 2015, Indian CMOs are strategizing to strengthen their current offerings to their clients by capturing new technologies to meet the requirements of prospective clients. Most of the companies engaged in manufacturing services are spreading to cover the entire gamut of services to gain recognition in the industry as CRAMS organization. Mr Anil Kubchandani, vice president and growth unit head-exclusive synthesis, Jubilant Life Sciences, says, â€œThe top 20 companies account for 50 percent of the revenue and rest is shared by smaller players. With the developed countries having stagnant market for CRAMS companies, outsourcing has added to growth of markets such as China, Russia and India.'' India is a hub for the largest number of US FDA-approved plants outside the US and also having developed competency for the regulatory requirement of UK and European markets. Globally, the services provided under manufacturing comprise custom synthesis, scaling up and large scale production, active pharmaceutical ingredients (API), intermediate manufacturing and formulations involving varied dosage forms. Citing the paradigm shift in the CRAMS industry, Mr Manoj Mehrotra, head, global CPS business, Dr Reddy's Laboratories, says, â€œBig pharma companies are shutting down R&D centers and venturing into emerging markets. Outsourcing is catching up in a big way as in-house R&D is no longer feasible in the wake of increased costs.'' In the recent past many companies have outsourced to reduce their cost burden from manufacturing and concentrate more on increasing their sales and new product development in the emerging markets. Kemwell Biopharma has entered a strategic collaboration with Boehringer Ingelheim, Germany, for scaling up of analytical facilities in cell banking and characterization. Mr Durgaprasad Annavajjula, senior VP, R&D, Kemwell Biopharma, says, â€œIt takes 2,090 crores, ($400 million) to 10,450 crore ($2 billion) in order to start a facility in three-to-five years. However, it doesn't take much to buy CMOs. So there are tremendous opportunities for the CRAMS industry. Besides that, new areas such as biotherapeutics are going to be the new booming segment.'' Hurdles before services sector Talking about the issues faced by the industry, Dr Rashmi Barbhaiya, CEO and MD, Advinus Therapeutics, said, â€œThe issues that we face currently need to be dealt with seriously as our future looks bleak when compared with competitive countries.â€? While using strong words, he added, â€œThe Indian industry needs a level playing field, so that it is not at a competitive disadvantage.â€? The challenges faced by the industry include issues such as intellectual property, competition with international competitors like China, safety concerns, long regulatory timelines, rise in the manufacturing cost, lack of effective project management capability, non-tariff barriers from developed countries and inadequate facilities to conduct studies. Mr Madhusudan Rao, COO, global generics, Orchid Chemicals and Pharmaceuticals, says, â€œThere are shortfalls in talent, limitation in technology, problems in satisfying a client with huge expectation, confidentiality issues and the quality is still not good enough and up to the mark.â€? The regulatory hassles are taking its toll on the industry. The industry experts belive that numerous approval agencies have led to the chaos and is a major deterent for hassle-free functioning. Mr Apurva Shah, chairman, Association of Contract research Organizations (ACRO), feels that both the government and the industry has to be more proactive in resolving the issues. â€œThe government must stick to the regulatory timelines. The Drug Controller General of India (DCGI) must have a proper mechanism in place to deal with the regulatory hiccups,â€? he says. Mr Shah, who is also the group managing director of Veeda Clinical Research, adds, â€œBenchmarking is required and that incudes catagorization of CROs in which ACRO has to be involved. There must be a legislation for making the good laboratory practice (GLP) mandatory for preclinicals.â€? Ms Vineeta Sharma, advisor and head, national good laboratory practice (GLP) compliance monitoring authority, Department of Science and Technology, says, â€œThe GLP-graded India has received a great but cautious response as the third party audit is still lacking.'' The shortage of skilled human resources and increase in the rate of attrition is another important area where the CRAMS industry has been finding itself helpless. Dr Rama Mukherjee, managing director, ARA Healthcare, believes that institutions lack the right training program. â€œThe educational courses too require regulation at the right level as this is dampening Indian capabilities,'' says Dr Mukherjee. Commenting on this, Mr Apurva Shah says, â€œThe practicality of courses is missing and is a neccesssity. We have scientific workers but not scientists. Veeda is putting in place a program for students in audit and training.'' Keeping the growth trajectory moving The government and the industry agree that the streamlining of work between various regulatory agencies would be a great boost for the smooth functioning of the CRAMS companies. Going further, the Department of Pharmaceuticals, Government of India, is in the process of setting up a website jointly with ACRO to list all the CROs and CRAMS companies in the country. The deadline for the same has been kept as January 13, 2012. Maintaining that the regulators cannot be blamed for all the ills faced by the CRAMS industry, Mr Devendra Chaudhary, secretary, Department of Pharmaceuticals, Government of India, says, â€œThe industry has to be more responsible and it would be great if it could function with a self regulatory model to minimize the loopholes.'' Dr Vibhav Garg of CII has proposed a consoritium of CRAMS companies that may have the power to do self-compliance and self-certification. Dr Garg says that the industry may try to help the goverment in minimizing its role by following self-compliance and then proceed to the DCGI for approval. Although he agrees to its uniqueness, Mr Madhukar Rao says, â€œThe regulatory authorities generally prefer their independence. It can be part of a regular discussion but cannot be implemented right away.'' Comparing CRAMS with the IT industry, Mr Manoj Mehrotra said, â€œWe have to ensure that we tap the opportunities by improving the supply chain and ride the wave. We have not achieved so far what our counterparts in IT have done.'' Dr Arjun Surya, president and CSO, Curadev Pharma, says, â€œIt would be arrogant on our part if we think that everyone will come to India. We have to always keep the competitive countries in mind and it is certainly going to be make or break for us.'' The experts point to the fact that China has less than 50 US FDA-approved plants, while India has 100 such plants. Despite the fact that the Chinese API market has registered a drop due to quality issues, the number of innovation facilities are more as compared to India. It is the right time for the authorities to find a solution to the genuine issues, which will boost the morale of the industry and prevent any loss of work due to competition. Rahul Koul in New Delhi ]]> <![CDATA[Mark the dates!]]> https://biospectrumindia.com/news/95/5883/mark-the-dates.html https://biospectrumindia.com/news/95/5883/mark-the-dates.html Mon, 12 Dec 2011 11:20:00 +0530 India BIO 2012 - Bangalore The 12th edition of Bangalore India BIO will be held on February 6-8, 2012 in Bangalore. This three day event aims to focus on areas that are essential to make India a strong bioeconomy. The event will consist of a multi-track conference, international trade show, BioPartnering India, vision leadership series, CEO conclave (featuring a panel discussion between top CEO's), a poster session 'Walkway of Discovery', BioQuiz for biotechnology students along with Bio-excellence Awards for companies and individuals. BioPartnering India, one of the key features of Bangalore India BIO, offers a unique platform for delegates to scout for partnering opportunities with the global biotech community. The BioPartnering India initiative in 2011 received phenomenal response with over 530 business meetings facilitated. It will also discuss issues such as collaborative and integrative business models as well as policy, regulation, and investment challenges for biotechnology in a global bioeconomy and will provide networking and knowledge sharing platform for business leaders, policy makers, research heads and academia. BioAsia 2012 - Hyderabad The ninth edition of BioAsia, with the theme of 'Optimizing Opportunities', will be held from February 9 to 11, 2012, at Hyderabad. It will focus on CROs, IPR, vaccines and investments. The event promises to be the door to opportunities with the participation of a dynamic mix of high profile industry thought leaders, policy makers and other key stakeholders of the industry. BioAsia has also gone a step further to augment the global event through a basket of satellite event offerings, such as BioBazaar, BioPartnering, CEO conclaves, tradeshow, policy discussions, conferences and more. At the curtain raiser of the event, held in Hyderabad, Dr KV Raghavan, vice president of Federation of Asian Biotech Associations and former director, Indian Institute of Chemical Technology, said that representatives of the top 16 MNCs in bio-pharma arena have confirmed their participation. A state-of-the-art partnering system which integrates professional and social networking platforms will also be part of this prestigious event. Mr Shakthi Nagappan, CEO of BioAsia 2012, announced the list of partners for BioAsia 2012, which includes Frost & Sullivan, Confederation of Indian Industries, Institute of Life Sciences, Alexandria Equities Management, Lonza India, Hyde Engineering & Consulting and Yes Bank, among others. Further, the organizers announced the support from various parts of the globe through regional industry associations like SwedenBIO, Swiss Biotech, AusBiotech, Biocat (Spain) and European Federation of Biotechnology among others. BioAsia 2012 has already attracted high profile speakers and global thought leaders like Dr Richard Connell, vice president and head of R&D, Pfizer, Shanghai; Dr Ajit Shetty, president, Johnson & Johnson, Dr Hasit Joshipura, VP and MD, GSK; Mr Pankaj Patel, chairman, Zydus Cadila; Dr N K Ganguly, chairman, Immunology Foundation and former director general, Indian Council for Medical Research; Dr Suresh Jadhav of Serum Institute of India; Dr Darren JI, CEO, PharmaLegacy Labs, China; Dr Cyrus Karkaria, president Biotech, Lupin (India), among others. ]]> <![CDATA[Researchers to the fore in BioSpectrum Awards]]> https://biospectrumindia.com/news/95/1080/researchers-to-the-fore-in-biospectrum-awards.html https://biospectrumindia.com/news/95/1080/researchers-to-the-fore-in-biospectrum-awards.html Fri, 09 Dec 2011 17:38:00 +0530 Last month, we provided some glimpses into the selection process for the annual BioSpectrum Awards. The suspense is over and as usual the December issue of BioSpectrum is devoted to the coverage of the high achievers of the Indian biotech sector. There is something special this time apart from the newly instituted award that recognizes the best public private partnership (PPP) in the biotech ecosystem. This year's awards are dominated by highly accomplished researchers. And more interestingly, two research teams that are working hard to minimize the impact of malaria, one of the earliest scourges of human civilization, which has eluded a fool-proof cure so far. Topping the list is the quiet and unassuming Lalji Singh who received the 9th BioSpectrum Lifetime Achievement Award 2011 for his pioneering work in introducing the DNA fingerprinting technique to the nation. Lalji, as he is affectionately called by everyone in the biotech community, has just completed his 11-year-stint as the director of the Center for Cellular and Molecular Biology, Hyderabad. This is the culmination of nearly four decades of outstanding work as a geneticist both in India and abroad. Good scientists never retire and so Lalji is moving on to take up even greater responsibilities as the vice-chancellor of Banaras Hindu University, his alma mater and also one of the country's oldest and prestigious educational institutions. Today DNA fingerprinting has become a routine process in untangling many complex civil and criminal cases. It was Lalji who single-handedly championed this technology's cause for over two decades. The jury made a slight departure and decided to name both Dr Virander S Chauhan and Dr Chetan Chitnis, from ICGEB, New Delhi, as the BioSpectrum Persons of the Year 2011. This is for the first time that there is a joint winner for the BioSpectrum Awards category. Why the jury found it difficult to separate their work is something I am not going to explain. Their profile is self-explanatory. The entire scientific world is viewing with interest the duo's latest discoveries about the malarial parasite, which may eventually lead to the development of a vaccine to prevent the occurrence of this disease which claims millions of lives every year on our planet. As Dr G Padmanaban observed: â€œ... They are the only group in the country to have embarked on developing vaccines against falciparum and vivax malaria, which has been an international challenge for decades.â€? While the ICGEB scientists are developing a preventive vaccine, the first PPP awardees- Dr M Z Abdin of Hamdard University, New Delhi and Dr D C Jain of Ipca Labs, Mumbai - have done some great work to enhance the availability of key ingredient used in malaria treatment drugs and hence make it more affordable and accessible to the world's poorest people. The BioSpectrum Entrepreneur of the Year, Supreet Deshpande, founder of VLife Sciences, Pune, is a die-hard entrepreneur who ventured into the life sciences field from his core expertise in the telecom sector, just for the love of it. The company's unique business model has got the thumbs up from some of the country's most hard-nosed venture capitalists. And Deshpande's small team has returned the compliments in a big way by developing a strong pipeline of eight drug candidates in a very short time. Panacea Biotec's PacliALL, the highly talked about breast cancer treatment drug, is a path breaker in the use of nanotechnologies to make the treatment more affordable and minimize side-effects. The details of the award ceremony, slated for 16th December in Bangalore, are given in the magazine. Please come in large numbers to cheer these outstanding achievers who are making the biotech community proud. Narayanan Suresh Chief Editor sureshn@cybermedia.co.in ]]> <![CDATA[Affordable Malaria Treatment: Hope for Millions]]> https://biospectrumindia.com/news/95/5884/affordable-malaria-treatment-hope-for-millions.html https://biospectrumindia.com/news/95/5884/affordable-malaria-treatment-hope-for-millions.html Fri, 09 Dec 2011 17:35:00 +0530 Public-Private Partnership Excellence Award 2011 Utilizing public and private funding, Jamia Hamdard and Ipca Laboratories are engaged in a project to enhance the artemisinin content in Artemisia annua L plants. This is a big step towards making malaria treatment affordable and accessible in the South East Asian and African countries, where this disease is an endemic According to the World Health Organization (WHO) recommendations issued in April 2006, the treatment of uncomplicated malaria with artemisinin-based combination therapies (ACTs) can protect the artemisinins and the partner drug from resistance in the wake of reduced efficacy of the well-known once-first-line antimalarials such as chloroquine, and sulphadoxine-pyrimethamine. However, due to short supply of artemisinin, the cost-per-treatment course of ACTs (108.70) over conventional antimalarial drugs (4.60) is high. Consequently, the prices of these drugs are subsidized with government funds or with funds obtained from charitable organizations. Therefore, to meet the global demand of artemisinin, it is required that the plant Artemisia annua L (A annua L) should yield high amount of artemisinin uniformly throughout the population which has not been possible because of cross-pollination and variable segregation of segregants. "Besides antimalarial property of A annua L plant, it has shown great potential in treating some other infectious diseases like schistosomiasis, HIV, hepatitis-B, leishmaniasis and a variety of cancer cell lines including breast cancer, human leukemia, colon cancer, and small cell lung carcinomas. This project will help to increase the income of farmers, thus stimulating their interest in the cultivation of A annua L plant. As the Indian economy is mainly based on agriculture, this project would help to strengthen the economy." Dr M Z Abdin professor of biotechnology and dean, faculty of science, Jamia Hamdard University Inception Way back in 1994 when Dr M Z Abdin, professor of biotechnology at Jamia Hamdard University, started his research on Artemisia annua plants, he did not have the slightest idea that his research would get transformed into something gigantic after a decade. Dr Abdin who is now the dean, faculty of science, Jamia Hamdard, is confident about the high medicinal value of plants in curing malaria. Over a period of time, he continued with his research and strived to create better varieties of plants having better yield of artemisimin, which is required for the treatment. The funding agencies were reluctant to fund his initiative at first. However, Dr Abdin, supported by the university, relentlessly continued his efforts without losing focus. In 1994, the Department of Biotechnology (DBT), Government of India, provided funding close to 35 lakh for a project related to the study of biosynthetic pathway of artemisimin. After a gap of six years, he again got a funding of 10 lakh from the DBT for work on hmg co reductase enzyme and its regulation, which was actually related to the improvement of the plant variety. The research finally reached the stage where ads gene from Artemisia annua was cloned and the regeneration protocol was optimized from the leaf explants. The whole plant was regenerated from the leaf explant and the transformation protocol was optimized using agrobacterium and binary vectors. "This project was in sync with the basic needs of the country's population and therefore it has been a huge step forward towards addressing the affordability issues in malarial treatment. Such partnerships must be encouraged and government agencies have to be more generous in their funding for those researchers who are working in key areas." Dr G N Qazi vice chancellor, Jamia Hamdard University While Dr Abdin was working in New Delhi, another scientist, Dr D C Jain, was also pursuing similar research in the area of antimalarial drug development from Artemisia annua at the Central Institute of Medicinal and Aromatic Plants (CIMAP), Lucknow. During the 90s, Dr Jain was the pivotal scientist in the successful implementation of the project at CIMAP. The efforts of Dr Jain, who now is the general manager, Green Tech Department, Ipca Labs, converted into a new antimalarial drug Arteether and a new Artemisia annua variety for commercialization in India. This work was recognized with the CSIR Process Technology Award 1998, and the new plant variety 'Jeevan Raksha' was dedicated to the nation by the then Prime Minister of India, Atal Bihari Vajpayee, in 1999. Turning Point The initial idea of Dr Abdin transformed into reality when in 2003 he met Dr D C Jain, while attending an international conference on malaria in New Delhi. After initial discussions, both realized that by working together, they could develop a new strain altogether. Around the same time, Dr Jain joined Ipca Labs Ratlam and collaborated with Jamia Hamdard for sharing information and work on a regular basis. "This project shows that prioritization of research in major disease areas can certainly make a big difference. I hope that we will be able to commercialize the product as soon as possible. India requires more of such initiatives for the larger benefit of the masses" Dr D C Jain general manager, Green Tech Department, Ipca Labs The biotechnology department of Jamia Hamdard had already conducted research to improve the yield of artemisinin by applying various approaches like agrotechnology and tissue culture. It had already engaged in developing transgenic lines of some important medicinal plants. But now was the time to use the other high-end technologies, such as genetic engineering. Therefore, Ipca Labs signed an MoU with Jamia Hamdard in 2007 to collaborate in enhancing the yield of artemisinin by applying metabolic engineering approach. Artemisinin is commercially produced from Artemisia annua L plants with a content of 0.01-1.0 percent. The Jamia research team, with the help of Ipca Labs, developed a novel strain of A annua L through bioengineering mevalonate and artemisinin biosynthetic pathways by over-expressing hmgr and ads genes, encoding key enzymes of these pathways. The bioengineered strain of A annua L had around 160 percent higher leaf biomass and 90.91 percent artemisinin as compared to the mother variety (received from Ipca Labs). More recently, Ipca Labs and the Department of Science and Technology (DST), Ministry of Science and Technology, Government of India jointly sponsored a major research project of Jamia Hamdard for developing a noble strain of A annua L with high artemisinin content through genetic manipulation in 2011. "When Ipca started out with this project, our objective was to increase the yield of the artemisinin content in Artemisia annua L plants which will be a great boon in the cure of malaria. This product is relevant to the population in countries like India and Africa where the incidence of malaria is high and anti-malaria drug is expensive. This product will ultimately be for the masses, because the project not only looks at scaling up production, but also looks at increasing availability and providing it at affordable prices to the population. Currently, it is in its lab stages and around 50-60 percent of the project is already complete at Jamia Hamdard" Dr Ashok Kumar president, R&D, Ipca Labs Jamia Hamdard has so far received 97.64 lakh from these agencies as funds for the project. While the role of Jamia has been to improve the varieties and develop new strain, Ipca Labs is focused on scaling up the production and commercialization of the product. Ipca Labs has funded 30 percent of the total cost of the project. According to Dr M Z Abdin, â€œThe government agencies and the biotech industry should make efforts to run projects on the PPP model. This will facilitate major projects leading to the development of products, which ultimately benefit the public at large and support the growth of the biotech industry. It will also help increase the knowledge base and the economy of the country.â€? Echoing similar views, Dr D C Jain, says, â€œTo carry out major research projects like the present one, the funds received from the government and the industry are extremely essential. They are used to hire manpower, chemicals, consumables and instruments. These components are important for the successful completion of the project.â€? Scaling up efforts At present, the stability and inheritance of trans hmgr and ads genes in the newly developed strain of A annua L plants is being studied. Also, the parameters related to growth and yield of artemisinin in this variety are being evaluated. It is being expected that the metabolic engineering approach pursued in this study will lead to the development of a novel variety of the plant with artemisinin content more than 1.5 percent. This variety can be patented and released to the farmers for mass scale cultivation and will ultimately lead to higher production of artemisinin. After the Institutional Biosafety Committee at Jamia cleared the proposal, the application was filed before the Review Committee on Genetic Manipulation (RCGM) for the approval of confined trials of the genetically engineered plant followed by open field trials. After the clearance, Ipca Labs is expected to carry out field trials of this strain in 2012-13 seasons. â€œHopefully, the newly developed transgenic line of A annua L plant will be commercialized by the end of 2014 and it would help to accommodate the gap between demand and production of artemisinin,â€? says Dr Abdin. Ruling out fears that may arise due to the GM origin of the product, Dr Jain says, â€œMuch hype has been created about GM crops, so it will be a little hard to make people accept such products. However, this product is very safe to use and harmless to people's health and environment.â€? As per the conditions laid out at the time of the initiation of the partnership, the patent of the product will be owned jointly by Jamia Hamdard and the DST. At the same time, Ipca Labs because of its contribution, will get the first priority for using it commercially. While the revenue generated by the sale of the patent will be shared by Jamia and the DST, Ipca Labs would benefit at the commercial level with some percentage of earnings given to Jamia. -Rahul Koul in New Delhi ]]> <![CDATA[PacliALL leverages the nanoparticle advantage]]> https://biospectrumindia.com/news/95/5953/pacliall-leverages-the-nanoparticle-advantage.html https://biospectrumindia.com/news/95/5953/pacliall-leverages-the-nanoparticle-advantage.html Fri, 09 Dec 2011 17:33:00 +0530 BioSpectrum Product of the Year Award 2011PacliALL The indigenously developed PacliALL from Panacea Biotec is a formulation of albumin-bound Paclitaxel particles. The product is more affordable and safer than the conventional formulations of Paclitaxel as a chemotherapeutic agent for the treatment of breast cancer According to the World Health Organization (WHO), female breast cancer is one of the major challenges and one out of every eight woman is likely to suffer from this dreaded disease by 2020, across the globe. Therefore, in a developing country such as India, where more than 80,000 patients have been diagnosed with breast cancer every year, PacliALL is seen as a major relief to patients since the treatment costs are highly unaffordable. Launched by Panacea Biotec on Feb 12, 2011, the indigenously developed PacliALL uses one of the world's most advanced particle size optimization technology to reduce serious adverse effects, including severe anaphylaxis and sensory neuropathy associated with conventional Paclitaxel formulations. The new product also offers several patient convenience aspects like shorter infusion time and elimination of need of premedication. The product is available at a price that is approximately 50 percent less than its competition in domestic and global markets. The product is priced at 9,000 per vial as compared to 18,000 per vial in the international market. The unique selling point of PacliALL is that it is three times more efficacious than conventional, solvent based, Paclitaxel, in terms of response rate. It is free from the undesirable side effects of chremophore like anaphylaxis and skin reaction and higher grade neutropenia among others. Also, the patients need not to be treated with pre-medication, containing steroids. Drug related neuropathy is reversible unlike the conventional, solvent based, Paclitaxel. With this product, a higher dosage of aprroximately 1.5 times can be given to patients, without the risk of increasing side effects. The intra tumor concentration of drug is very high when compared with the conventional one because of targeted delivery. According to the company, the product has been well accepted and is being used across the length and breadth of the country. Within three months, the volume of sales (units) is almost equivalent to that of the brand leader. With the market size of the drug in India estimated to be about 180 crore, the company is expecting to grab around 10 percent market share within a year. Panacea Biotec sees great potential for the product in the rest of world. The company is in the process of setting up a new manufacturing facility at Baddi, Himachal Pradesh, in order to cater to the world market. About the future plans, Dr Sarabjit Singh, vice president, R&D, Panacea Biotec, says, â€œWe intend to provide this product for global healthcare needs, complying to the best quality standards and make it an affordable therapy.â€? Birth of the product The research on the project started almost six years ago with the objective of bringing the latest, state-of-the-art safe and effective medication to the country. These areas included the nanoparticles, microparticles and liposomes. At that time, the company was already into novel drug delivery system with an R&D center located at Lalru, Punjab, with focus on oral drug delivery. Narrating the idea behind the product, Dr Rajesh Jain, joint managing director, Panacea Biotec, says, â€œWe decided to move away from conventional technology and develop something that was upcoming at that time. We hired a core team of scientists to look into this area of advanced drug delivery system and found that nano-particle technology could help treat breast cancer patients with fewer side effects and efficaciously.â€? In 2005, the company hired some space on the premises of SNDT Women's College, Mumbai, and started research on nano-particles. They also started work on the R&D Center, which is now known as global research and development (GRAND), Navi Mumbai. The work at the center, inaugurated on February, 11, 2008, was conceptualized over four core areas of advanced drug delivery through specially programmable oral drug delivery system. Taking it to the market A team of about 15 scientists from India and abroad worked dedicatedly to make this product a market reality. The technology involved emulsion-solvent evaporation and is based on the principle of high pressure homogenization. Paclitaxel and albumin are in intimate mixture and of a controlled particle size of less than 150 nm. The final product is stabilized by lyophilization. Without giving the exact amount of investment to develop this product, Dr Jain points out that the process of investments is still on. 'We are far ahead of competition' Dr Rajesh Jain, joint managing director, Panacea Biotec Is there any room for improvement in the cost of PacliALL? Dr Rajesh Jain: Further possibilities for improvement in the product cost may not be feasible at this stage. At present manufacturing and supply of the product is from a pilot plant at the GRAND R& D Center, Mumbai, which is not enough for us to venture in global markets. Therefore, we are investing 55 crore in setting up a commercial anti-cancer formulation facility at Baddi, Himachal Pradesh. The same is expected to be licensed and inaugurated by Feb 2012. In the next three years, the product will be globalized and we expect it to do well across the developing markets, such as Africa, CIS Republics and Latin America. Once we obtain returns on our investment, we can subsequently look at reducing the price. Although this is the investment phase for us, we never wanted to keep patients waiting for the product. While it is important to use advanced technology, it must come with a price tag that is affordable to people. How do you view the competition? Dr Rajesh Jain: At present the market is quite large, equivalent to $500 million. We believe that competition is healthy as it helps us to focus on the value we deliver to the customer in the absence of which one is not successful. The right spirit in a competitive environment will help in bringing down the price, offer a better product to the ultimate beneficiary, the patient. Our business is about saving lives. When you look at the global generic players, they are focusing on reduction in price of already existing conventional Paclitaxel product. Our product development strategy includes three important aspects: affordability, efficacy and safety. Currently, the focus of the competition is on price. So, we feel that we are much ahead and they have a long way to go. What are your views on cancer research and drug discovery in India? Dr Rajesh Jain:We have a long way to go in cancer or drug discovery research. Indian academic research is not focused on outcomes that aim at products for different diseases, either in India or overseas. What is the need of the hour? Dr Rajesh Jain:I think with time, the academia, government and the industry have matured and now it is time to synergize our efforts to create new innovative but affordable drugs from India for the developing world. We need translational capabilities with a proper support system, such as national laboratories that can supply cell lines, reference standards, enabling animal model for efficacy studies and new targets among others. The product is reconstituted immediately before infusion. Complete manufacturing of the product is carried out in a state-of-the-art isolator facility, ensuring safety of the formulator and the product. â€œIt took us approximately six years from idea to commercialization. Major stages of development included strategizing path of development, machinery to prepare nanoparticles, preparing the product on lab scale, establishing proof-of-concept, scaling up to GMP guidelines and finally validating the upscaled process,â€? says Dr Sarabjit Singh. â€œThe objective of Panacea Biotec is to take ideas to the market in a proactive manner and establishing brand India globally in sync with its adage â€œThink Medicine Think Indiaâ€?. We will remain committed to its mission providing the latest and most affordable preventive and therapeutic care to people across the globe. The launch of PacliALL reflects the hardwork of Panacea Biotec's scientists who worked tenaciously for the development of this drug,â€? adds Dr Rajesh Jain. Rahul Koul in New Delhi ]]> <![CDATA[On quest for malaria remedy]]> https://biospectrumindia.com/news/95/1899/on-quest-for-malaria-remedy.html https://biospectrumindia.com/news/95/1899/on-quest-for-malaria-remedy.html Fri, 09 Dec 2011 17:25:00 +0530 BioSpectrum Person of the Year Award 2011 Ignoring greener pastures abroad, they returned home to steer the efforts in malaria vaccine research and development. For both Dr Virander Singh Chauhan (R) and Dr Chetan E Chitnis (L), science is not just a livelihood, it is a huge responsibility towards society. With their breakthrough research on the malarial parasite, Dr V S Chauhan, director, International Center for Genetic Engineering and Biotechnology (ICGEB), New Delhi, and Dr Chetan Chitnis, principal investigator, malarial group, ICGEB, have brought India one step closer to the dream of having a vaccine for malaria. Their decade-long work led to the development of a first generation vaccine, MJAIVAC1, which is based on combination of two merozoite antigens (MSP-119 and EBA-175). The vaccine is presently being tested for safety and immunogenicity in a phase I clinical trial, the first for a malaria vaccine developed in India. The ICGEB has also developed a portfolio of novel antigens that is currently at different stages of pre-clinical development. Also, the center has developed a vaccine, PvDBPII, for Plasmodium vivax and it is being produced by a biotechnology company for a phase I trial. The ICGEB program has been largely funded by the Department of Biotechnology (DBT), the Bill & Melinda Gates Foundation, Malaria Vaccine Initiative and the European Vaccine Initiative. Taking malaria head-on Dr V S Chauhan, who joined the ICGEB in 1988, chose to take the less trodden path. He looked at the blood stage of the parasite and cultured it in the lab. He studied Plasmodium falciparum free merozoites and infected red blood cells (RBCs) that distinctly affect soluble CD40 ligand-mediated maturation of immature monocyte-derived dendritic cells. Dr Chauhan also put his efforts into identification and characterization of a novel Plasmodium falciparum merozoite apical protein, involved in erythrocyte binding and invasion. In his own words, he had â€œnightmares about how to go forward during this challenging taskâ€?. "I have known Dr VS Chauhan for more than two decades. I always felt that he personifies the term 'leading from the front' because under his exceptional scientific caliber and vision, the ICGEB has transcended into a center with emphasis on innovative and path breaking research. I had the opportunity of visiting Dr Chetan Chitnis' Laboratory of Parasitic Diseases at the NIH, US, in 1993. He came across as a trailblazer with a passion for serious research" Dr T S Rao adviser, DBT, Ministry of Science and Technology, Government of India His malaria group at the ICGEB developed procedures to prepare recombinant vaccine target antigens and the vaccine formulation was developed with industrial partners for clinical trials in India. His work on understanding the mechanism of action of antimalarial drugs, such as chloroquine and artemisinin, led to the development of high throughput screens for malaria drug discovery. Dr Chetan Chitnis joined the ICGEB in 1996 with expertise in the area of host pathogen interaction. Before this, he had worked as a post-doctorate scholar in a research group headed by Dr Louis H Miller at the National Institutes of Health (NIH), US. The work helped him understand that the binding process between the parasite and the host takes place through a protein on the former, called the duffy-binding protein. Subsequently, Dr Chitnis returned to India and continued his research and his experience helped him look at identifying the binding region of duffy-binding protein and making antibodies to block further invasion. After setting-up his lab at the ICGEB, Dr Chitnis further narrowed down the duffy-binding region and identified the amino acids involved in the binding process. â€œWe did a lot of structure functional studies on the binding domain,â€? adds Dr Chitnis. His team identified the exact binding pocket. â€œThese processes are important because vaccine for malaria parasites is difficult to make due to its variations. If you make a vaccine for one, it will not work for another parasite,â€? he adds. "A very good example of team work, combined with innovative research embedded in excellent basic science" Dr S Natesh senior advisor (scientist-H), DBT, Ministry of Science & Technology, Govt. of India The team at IGCEB, led by Dr Chauhan and Dr Chitnis as the principal investigator, chose to work on more difficult but potential areas. Efforts were directed at building the rationale for blood stage malaria vaccine candidates based on Plasmodium falciparum and Plasmodium vivax proteins that mediate erythrocyte invasion. Dr Chitnis and the team also developed another vaccine for plasmodium falciparum by identifying erythrocyte-binding protein on malarial parasite that binds to the host red blood cells (RBC). The development of vaccine for Plasmodium falciparum was divided into two components. One component-based research on merozoite antigens was conducted by Dr Chauhan and his team, while the other component was developed by Dr Chitnis and the team. They mixed the two components and developed the vaccine on the same rationale that antibodies block invasion of the parasite. The methods have been transferred to Hyderabad-based Bharat Biotech. "Prof Virander Chauhan and Dr Chetan Chitnis are two highly accomplished malaria researchers who have jointly developed India's first indigenous malaria vaccine that is currently in phase I clinical trials in India. Translational research is an extremely challenging task and their successful efforts have placed India as a strong player globally in malaria vaccine development. They both continue to lead high quality malaria research programs and their achievements deserve many congratulations and appreciation" Dr Deepak Gaur principal investigator, Malaria Group, ICGEB Dr Chauhan, who dedicates the success to the young members of the team, says it is teamwork that has brought them so far. Appreciating him for the freedom he has given to the researchers, Dr Chitnis says, â€œthe ICGEB gives the freedom to do things. There is no bureaucratic set-up here and Dr Chauhan has provided us all the liberty to do things.â€? Both Dr V S Chauhan and Dr Chetan Chitnis remain skeptical about the breakthrough achieved because of the adaptability and mutability of the pathogen involved. â€œWe are at the verge of getting somewhere but can't say that we are fully sure. Breakthrough in my understanding may work or may not,â€? says Dr Chitnis. â€œAny breakthrough is welcome, after years of hard work. But these are long processes that include the phase I and II and the final field trials.â€? Eyes set on challenges The people who are duffy positive are more vulnerable to malaria as against those who are duffy negative. â€œIn Africa, most of the people are duffy negative, hence, malaria incidence is low. In India, most of us are duffy positive, hence we are more prone to malaria,â€? says Dr Chitnis. Dr Chauhan adds that vaccines can't be the final solution and drug development needs attention. Raising an important issue of possible artemisnin resistance, he says, â€œThere have been reports of resistance in Cambodia, Thailand and if it reaches Burma and the Northeastern part of India, then things can get very messy.â€? "Both of them richly deserve the Biospectrum Award, 2011. They have carried out pioneering studies with the malarial parasite, both in terms of understanding the basic biology and applying the knowledge to contain this disease. They are the only group in the country to have embarked on developing vaccines against falciparum and vivax malaria, which has been an international challenge for decades. This is a unique effort in global terms and is recognized as such" Dr G Padmanaban National Academy of Sciences, India (NASI)-platinum jubilee chair/ hon professor, Indian Institute of Science, Bangalore â€œI am worried about the fact that there is no drug available for hepatitis C, dengue, chikungunia and there is also a fear of drug resistance. We need to do something about it immediately as Artemisnin should be used only with a drug but it slows down the process. Both with tuberculosis and malaria, we are near the end of the road. We have to start working on it right now and keep investing heavily,â€? adds Dr Chauhan. Both Dr Chauhan and Dr Chitnis agree that quality papers are being published and researchers are doing good work in India. However, research in India has so far not been translated into products. Citing the lack of a skilled workforce for translation in the academia, he says collaborations with the industry is important. â€œThe basic research of academia and translation expertise of industry, combined together will definitely give more results,â€? says Dr Chauhan. Dr Chitnis doesn't consider the comparison of Indian enterprises with the West to be fair. Giving an example, he says, â€œWhen I was at the NIH, the annual budget was 1,56,000 crore ($30 billion), which is much more than the total funding of the agencies here put together.â€? Agreeing with him, Dr Chauhan says, â€œI think we don't have enough manpower. Government support is great and, being part of government committees, I understand how much the government is doing. The government-funded conferences were unthinkable a few years ago, but it is happening now.â€? Different roles, one goal Dr Virander S Chauhan, director, ICGEB, New Delhi Brought up in a middle-class family, Dr Virander S Chauhan struggled hard to study with little guidance from parents and relatives. Being the topper of his school earned him a National Talent Scholarship that played an important role in his life. Dr Chauhan, whose dream job was to be a teacher, joined St Stephens College as a lecturer after completing his masters' degree. He simultaneously worked on his PhD in chemistry at Delhi University and finished it in 1974. He received the Rhodes Scholarship and went to Oxford University, where he finished his D Phil in 1977. He came back to India in 1979 and chose to teach at IIT Kanpur, where he continued until 1981. He continued with his research at the University of Delhi and joined the International Center for Genetic Engineering and Biotechnology (ICGEB) in 1988 and headed the malaria research group. In 1998, he became the second director of the ICGEB but continued to lead the malaria research group. Dr Chauhan is also well-known for his work in the area of design, synthesis and utility of conformationally defined peptides and is the founder president of the Indian Peptide Society. He has published many papers and encouraged many well-known scientists to carry forward their research. Very fond of running at a younger age, Dr Chauhan now spends his free time listening to Indian classical music and reading. Dr Chetan Chitnis, principal investigator-Malaria Research Group, ICGEB, New Delhi Dr Chetan Chitnis comes from a family of scientists. While his father is an astrophysist, his mother is a biochemist. He spent his childhood in an environment where science was always a subject of discussion. â€œHowever, it took some time for me to actually figure out my interest. I did my integrated MSc course in physics from IIT Bombay,â€? says Dr Chitnis. Dr Chitnis received his PhD in biophysics from the University of California, Berkeley, and did postdoctoral research on malaria in the Laboratory of Parasitic Diseases at the National Institutes of Health, Bethesda. He was instrumental in starting the Malaria Vaccine Development Program, a joint venture between the DBT, PATH and the ICGEB. He has authored more than 70 research papers and has received many awards, including the Infosys Prize for Life Sciences, Shanti Swaroop Bhatnagar Prize for Medical Sciences, Wellcome Trust Senior Research Fellowship, Howard Hughes International Research Scholarship, and M O T Iyengar Award for Research in Malaria from the Indian Council of Medical Research. Being a dedicated researcher, Dr Chitnis believes that for a scientist, the real thrill is not in getting the awards but actually doing quality of research he does. He considers himself as fortunate to have the good mentor like Dr Liu Miller, who guided him at the NIH. A family man, Dr Chitnis spends most of his free time in the company of his children. He is a voracious reader and also enjoys hiking. Hopes for the future According to Dr Chauhan, India is coming up as the hub of vaccines. â€œThere are many vaccine factories. Half of Africa has been immunized with the vaccines produced in India. If we stay focused, the day is not far when we will be the leaders.â€? "Prof Chauhan has the special ability to make things happen. The malaria vaccine efforts of Prof Chauhan and Dr Chitnis has brought international visibility to Indian Science" Dr Navin Khanna group leader, mammalian biology, recombinant gene products, ICGEB Dr Chitnis is determined to focus his efforts on malarial research. For the duffy-binding protein, the team has identified molecules that help in invasion and subsequently identified signals that trigger secretion or release to the surface. This has opened up a new field of signaling mechanisms during invasion. And that, in turn, has opened up avenues of drug development. The phase I trial for falciparum vaccine is on and results are expected by March 2012. â€œIf the results are positive, then we will proceed to phase II. If the results are not satisfactory, we will have to go back and do modifications,â€? says Dr Chauhan. â€œIt is difficult to predict when will the actual product development happen, but if the things go on smoothly, then possibly we may have the drug by the next 10 years.â€? Dr Chauhan says his focus has been to do things well. â€œWe are keen on technology development and have transferred dengue detection kit and hepatitis C vaccine to the industry. We never give exclusive license as non-exclusiveness will help us to disseminate the technology. We may not make profit but we are not here to make money,â€? he says. -Rahul Koul in New Delhi ]]> <![CDATA[The Game Changer Geneticist]]> https://biospectrumindia.com/news/95/5736/the-game-changer-geneticist.html https://biospectrumindia.com/news/95/5736/the-game-changer-geneticist.html Fri, 09 Dec 2011 17:24:00 +0530 BioSpectrum Lifetime Achievement of the Year Award 2011 Widely regarded as the man behind DNA fingerprinting in India, Dr Lalji Singh has been a pioneer in developing and introducing the technology for a plethora of applications including forensic analysis and wildlife conservation. Dr Lalji Singh, 64, sits easy in his chair at the Center for Cellular and Molecular Biology (CCMB) in Hyderabad. When he met BioSpectrum, he was having a calm last day at work. However, his links to CCMB and to Hyderabad are far from severed. Not only his research group at CCMB continues to work under his guidance, his name is indelibly imprinted in the history of this illustrious organization. Among his most significant contributions is the setting up of the Center for DNA Fingerprint and Diagnostics (CDFD), which was an application of his research on genetics. Path breaking study: The origins of man Dr Singh along with his colleagues at the CCMB undertook a unique challenge of mapping the ancestry of the Indian population and in doing so, helped elucidate the migration route adopted by man, millions of years ago. Dr Singh proudly speaks about this landmark paper published as a lead article in Nature. This paper was a culmination of years of research. â€œWe had sequenced mitochondrial DNA of tribes in Andaman and Nicobar which showed that they were different from other population. We found that they do not resemble any of the populations in India or anywhere else. This data generated a lot of interest. Later in collaboration with the Massachusetts Institute of Technology, we undertook a project in which one million sequences were studied of selected populations in India,â€? he elaborates. He had an opportunity to present this data at the World Congress of Genetics held recently, in October 2011, at Montreal. Dr Singh further elaborates, â€œOur findings rule out Aryan invasion theory and prove the theory of Southern route of migration instead. It also showed India is made of a diverse population and that the research should not be limited to western populations.â€? Genome Foundation: Labor of love In tandem with the findings of the study, Dr Lalji Singh had put forth the need to find solutions for India-specific disorders. Dr Singh explains the idea behind his project, the Genome Foundation, when he says, â€œI started this foundation with the humble aim that if each citizen of India can donate 1 towards it, that amount can be used to improve the conditions of people in rural areas by better providing solutions specific to the Indian rural population. This would aim to provide better healthcare and bridge the gap between scientists involved in basic research with clinicians working with hospitals and also increase awareness among the rural population.â€? Dr Singh has been bestowed with numerous honors including the Padma Shri in 2004 and the prestigious Shanti Swarup Bhatnagar fellowship in 2009. Forty seven years after he started his career, Dr Singh continues to have an impact on the Indian public through various roles. In 1991, he was an officer on special duty tasked with setting up of the CDFD. However, even before the CDFD was spinned-off, as an independent entity, he was working hard to make DNA fingerprinting admissible as evidence in the court of law. Operating out of the center for excellence at CCMB, he was instrumental in getting forensic evidence accepted in an Indian court in 1988 in Thalassery, Kerala. This paved the way for the common man to get justice in more than 500 cases since. The technology has provided irrefutable forensic evidence in sensational cases such as the Naina Sahni 'Tandoor' case, Swami Premananda case and many paternity cases. After that first case in Kerala, Dr Singh became the most celebrated evidence-man. He was grilled countless times by many lawyers and had to painstakingly go over and over again explaining the science that proved to be the clinching evidence. The progress in the field of DNA fingerprinting caught everyone's attention and won many accolades including the CSIR Technology award in 1992. It was ironical that the CDFD had to investigate the murder of the very man who supported its inception in 1991. The CDFD aided in the investigation of the assassination of the then prime minister, Mr Rajiv Gandhi, by providing strong forensic evidence to convict the accused. "I am very pleased Dr Singh is being given this award. Very few scientists have made as strong an impact on Indian science as him. He revolutionized forensic sciences in our country when he developed DNA fingerprinting techniques and brought it into the realm of the common people. Also, he created history when he became the first Indian whose work was featured as a lead article in Nature. As the director of CCMB, he added new dimensions to it by always bringing forth new ideas such as LaCONES, the first laboratory of its kind. He constantly worked towards improving the technology at CCMB. Bringing him to CCMB has been one of my best decisions" Dr Pushpa Mitra founder director, CCMB Dr Singh today has his hands full with the responsibility of the vice chancellor of BHU and the head of the Genome Foundation, a non profit organization, that was incorporated in 2004. His dream is â€œhealth for allâ€? and he believes that personalized medicine will be cost effective in India. However, he feels that for this to take place, genetic testing has to be made available and affordable. Deeply connected with his roots, Dr Singh's heart goes out for rural India. Born in rural Uttar Pradesh, in the small village of Kalwari, in Jaunpur district, Dr Singh was lucky to have a school within six kilometers from his home and a father who was passionate about education and supported his dream. However, he wasn't dreaming about becoming a scientist but a medical doctor. It was fate that he missed the entrance exam date for medicine course and went on to apply to the zoology course at the BHU. That one step became the foundation of the sterling scientific career that followed. However, nothing came easy for Dr Lalji Singh. His interest in science had, in fact, taken root when he saw the central nervous system of the frog for the first time at the dissection class during his intermediate school. A young Dr Singh, who loved sports and mathematics, was enamored. His curiosity led him to dissect many frogs, that were captured sportingly from the village pond. The dissection lab, for him, moved at his home. So, the disappointment of not being able to make it to the medical school was huge for him. However, on his father's advise he decided not to waste time moping around but do some other course. Encouraged and goaded by his mentor and a friend of his father, Professor Nandan Lal Singh he dreamt big, went ahead and applied at the BHU. â€œWhen I applied, it was more like a pipe dream because BHU was a glorious university where only the best-of-the-best make it,â€? recounts Dr Singh. He had no idea how good he was, until affirmation came in the form of letter of admission from the BHU. And almost immediately, he hit his first roadblock. He discovered that, at 16, he was underage for the course by two-years. Professor Nandan Lal Singh who taught physics at the BHU stepped in to help this bright aspirant once again, and managed to influence an exemption on merit. The year rolled-on, results came, and Dr Singh made his mentor proud by remaining on top of his class. He went on to receive a gold medal in his batch of MSc zoology in 1966. 'There is a need to change the mindsets' How do you perceive the current situation in Indian universities? The best people in science should be in the environment of a university. In my own experience, I found that the right mentors can make a world of difference and today's students need that kind of mentoring. The problem is that the universities are compartmentalized. There is a need to change the mindsets. The approach should be integrated. The key is to try to create centralized facilities that promote translational research. A university like BHU is very much suited to research being carried out in this manner. How do you like your new job role as the vice chancellor of BHU? Administration takes up a lot of time and gives me less time to focus on research. However, this job role allows me to make a positive impact on a larger scale. Improving the academic atmosphere of BHU is on my agenda. While academics proved to be cakewalk for him, everything else was a task. The sudden change in environment took quite some time for him to adjust. It was during his time at BHU that Dr Singh found his life long mentor and guide in Dr Rai Chaudhari, the head of the department of zoology at BHU and a pioneer in the field of genetics in India. "Dr Lalji Singh absolutely deserves this award. Despite being a scientist, he actively advocated DNA fingerprinting on public platforms and all his efforts paid off when the government agreed to help set up a center such as the CDFD. It was his tireless efforts, which included setting up the initial protocols for the center, which made DNA fingerprinting the buzzword in India. His landmark papers on human genetics prove that he is one of the best human geneticists in India" Dr Seyed E Hasnain professor of Biological Sciences, IIT Delhi, and former director CDFD From guiding Dr Singh on his future doctoral thesis to welcoming him into his home in Kolkata post his doctorate, to teaching him how to make tea, Dr Singh credits Dr Rai Chaudhari with being the influence that shaped his life. It was Dr Rai Chaudhari who suggested that Dr Singh pursue his doctoral thesis in karyotyping of snakes. The karyotype or the complete set of chromosomes in a species, of different species of snakes was not yet done in India, until then. Along with the scientific challenge of the project, with this Dr Singh also faced the challenge of overcoming his fear of handling dangerous snakes, such as Indian cobras, pythons, banded krait, on a daily basis in order to collect blood samples. Reminiscing about those times, Dr Singh says, â€œIn the beginning I was afraid of snakes and would need the snake handler to hold the snake while I collected the samples. Later on, I became so adept at the technique that I would hold the snake with one hand, its tail under my foot, while I collected the sample with my other hand.â€? His efforts paid off when during his study, using C banding technique, he elucidated that during the course of evolution newer species showed the presence of W chromosome in females, which could be used as a marker for identifying the gender and species of any snake. His doctoral thesis set a precedent when it was published as a whole paper with full 62-page text in the international research journal Chromosoma. It was a first for any thesis to be published as it is. Path breaking in itself, the findings in his doctoral thesis was set to have even more important implications in the future, as he later discovered. Meanwhile, Dr Rai Chaudhari moved back to Kolkata. Dr Singh applied for CSIR fellowship. Restless at the distance from his mentor, he quit his job at BHU and followed Dr Chaudhari to Kolkata, partitioned his lab into two and started pursuing the sex determination gene lead in snakes again. The infrastructure in Kolkata was not up to the mark. However, he persevered on, while also trying to find better options to pursue this research. "I think there are very few scientists in India as honest and kind as Dr Lalji Singh. The technology for the Universal Primers could not have been done, had it not been for Dr Singh. He not only gave me a free hand in my research but also took it upon himself to handle all the bureaucratic matters involved with patenting our technology. On winning the 2009 BioAsia Innovation Award, Dr Singh, in a magnanimous gesture, made me keep the prize money associated with it. This is just one of the incidents which exemplify his selfless character" Dr Sunil Verma scientist, CCMB (former student of Dr Lalji Singh) He hit a number of roadblocks in his struggle to find a lab and a mentor who would support his research and take it further until be came in contact with Professor K W Jones, reader at the Institute of Human Genetics at the University of Edinburgh, UK. He wrote to Prof Jones expressing that he wanted to continue his research under his guidance. Prof Jones informed him that he had neither a project nor any funding for working on snakes. 'However, if Dr Singh can get his own fund he can work at Jones' lab'. That piece of communication motivated Dr Singh to take some action. The next milestone arrived in Dr Lalji Singh's life as a Commonwealth Fellowship for nine months for his research on snakes. He informed Dr Jones that he has received the fellowship and would like to start his research. Dr Jones wrote back that there are no snakes in Britain and that Dr Singh would be his own mentor as Jones hardly knew anything about snakes. A determined Dr Singh fixed his snake tissues in alcohol and set sail for the University of Edinburgh in 1974 to work under the illustrious Dr Jones, who had become Dr Singh's guide and mentor. Six months of his fellowship went on with little further evidence of his hypothesis of chromosome specific satellite DNA. He ran out of tissues and no further work was possible unless he got fresh snake tissues. At this crucial juncture, once again, Dr Rai Chaudhari stepped in with assistance. He sent him a consignment containing 30 live snakes to Britain. Success came to him when late one night, using in situ hybridization he saw the evidence of a satellite DNA specific to the W chromosome. In addition to being able to demonstrate that this satellite DNA was specific to a single chromosome, he also later showed that his DNA was associated with sex determination in all organelles including humans. These studies were further used to elucidate the pathways involved in sex reversal as well. However, just when he made such an exciting discovery, and was basking in the glory of his finding he got the rudest shock of his life, an order to return back to India within immediate effect. The Indian government wanted to stop the brain drain from the country and made efforts to bring the talent back to the country. The fact that Dr Singh was the one of the first young scientist award winners in India, he became the first casualty of the scheme. What followed were some of the harrowing days of his life. With his passport impounded, he was caught in a situation that made little sense to him. Finally, after many visits to the Ministry of Education and intervention of the Prime Minister's Office, he was allowed to go back to his research in Edinburgh. Crystallizing Achievements In 1987, Dr Singh was in Hyderabad at the invitation of Dr Pushpa Mitra Bhargava, the founder director of Center for Cellular and Molecular Biology (CCMB). At the CCMB inaugural, an event marked by the largest congregation of Nobel laureates until date in India, Dr Bhargava, who was working at getting talent for CCMB, inspired Dr Lalji Singh to join there as senior scientist. All of Dr Singh's conditions on infrastructure requirement was met. Dr Singh returned to India with his family, comprising wife and two sons, in tow to Hyderabad at the CCMB. His achievements at the CCMB are reflected in the fact that not only did he conducted outstanding research and published many papers but was also decorated with many awards. He rose to the position of director in July 1998 and took charge of the CCMB. At the CCMB, Dr Singh continued with his work on sex determination and with his colleagues and indigenously developed a probe called Banded Krait minor satellite DNA probe (Bkm-derived probe) that had applications ranging from forensic analysis to seed stock verifications. Leveraging research What sets Dr Singh apart from his contemporaries is that he has been using technology to help not just humans, but also the wildlife. Based on the studies of Dr Lalji Singh and his colleagues on wildlife conservation, the Government of India has set up a â€œLaboratory for the Conservation of Endangered Species (LaCONES), which is a unique initiative for the conservation and protection of Indian wildlife. One of the important findings of Dr Singh in this regard has been through the study of tigers from different reserves, which refuted the earlier claim that wildlife in India was genetically homogenous. Dr Singh provided evidence that there is sufficient amount of polymorphism in wildlife, such as tigers, from different parts of the country. Another highlight of Dr Singh's work was the study of conserved sequences in mitochondrial DNA that can be used as universal primers to identify any biological organism for which he acquired a joint patent with Dr S K Verma. During the 11 years that Dr Singh spent as director of CCMB, he spearheaded the research on the origins of man, which put CCMB on the world map. -Manasi Vaidya, and Nandita Singh in Hyderabad ]]> <![CDATA[Jury and BioSpectrum-ABLE Awards 2011]]> https://biospectrumindia.com/news/95/3881/jury-and-biospectrum-able-awards-2011.html https://biospectrumindia.com/news/95/3881/jury-and-biospectrum-able-awards-2011.html Fri, 09 Dec 2011 17:21:00 +0530 BioSpectrum Jury Award Winners 2011 BioSpectrum Lifetime Achievement Award: Dr Lalji Singh,vice-chancellor, Banaras Hindu University BioSpectrum Person of the Year Prof Virander S Chauhan, director, International Centre for Genetic Engineering and Biotechnology, Delhi Dr Chetan E Chitnis, principal leader, malaria group, International Centre for Genetic Engineering and Biotechnology, Delhi BioSpectrum Entrepreneur of the Year: Mr Supreet Deshpande, CEO & founder, VLife Sciences, Pune BioSpectrum Product of the Year: PacliALL by Panacea Biotec, New Delhi Special category: Public-Private Partnership Excellence: Ipca Labs and Jamia Hamdard University BioSpectrum-ABLE Company Awards 2011 BioPharma Company of the Year: Biocon BioIndustrial Company of the Year: Novozymes South Asia BioServices Company of the Year: Quintiles India BioAgri Company of the Year: Nuziveedu Seeds BioInformatics Company of the Year: Ocimum Biosolutions Technology Provider of the Year: Spinco Biotech BioSpectrum BT School of the Year Awards 2011 Public: Institute of Chemical Technology, Mumbai Private: Sastra University, Thanjavur ]]> <![CDATA[Leading from the front]]> https://biospectrumindia.com/news/95/2450/leading-from-the-front.html https://biospectrumindia.com/news/95/2450/leading-from-the-front.html Fri, 09 Dec 2011 16:41:00 +0530 BioSpectrum Entrepreneur of the Year 2011 A mechanical engineer with a passion for tabla, Mr Supreet Deshpande realized that information technology could help biotechnology firms while working in the telecom sector. He set up VLife Sciences Technologies in 2002 and today the computational chemistry company is cited in over 250 international publications and has eight candidates in the pipeline, one of which is in the human clinical trials stage. In less than a decade, Pune-based Vlife Sciences Technologies has come of age. While recording profits for the last four years and clocking revenue of 1.5 crore, the company also invested in creating intellectual property. In a short span of time, it has eight candidates in the development pipeline, with one of them in the human clinical trial stage. The man behind the company, Mr Supreet Deshpande says that the road to success has not been without hurdles. There were issues like feasibility of the venture, consistency in the inflow of funds, putting together a core team, long gestation period for return of investments and above all the high probability of failure. â€œHowever, you need to have patience and perseverance, and you must not succumb to disappointments because those are aplenty in this business. But above all, have faith in God,â€? he says. "Supreet has immense knowledge about the field. Their strategy of finding out new indications for existing approved drugs is unique and something that made us invest in their company. Their drug for diabetic foot ulcers has generated a high level of confidence among investors. The fact that they have received three rounds of funding is commendable, especially for a drug discovery company in India. To my knowledge, there are very few companies in India that are into drug discovery and have received so many rounds of funding " Mr Nitin Deshmukh chief executive officer, Kotak Private Equity Group An enthusiastic tabla player, Mr Deshpande learnt to play the instrument at the age of three and has given solo performances in over 35 countries. He cites an anecdote from his childhood days that gives a glimpse of his entrepreneurial capabilities. â€œOnce in order to get a theme right, I did riyaaz for 11 hours every day for seven days until I mastered it. Nothing in this world is difficult. If you keep trying you will overcome the obstacles. The universe is hand-in-glove with your struggle and determination,â€? he says. Pursuing an idea Mr Deshpande started his career with Bajaj Automobiles and then moved to Mahindra & Mahindra as the head of international marketing. He shifted to Pune when he was asked to join Mahindra British Telecom (now Tech Mahindra) as its business strategy head with the task of identifying other avenues of growth for the telecom business with focus on software. He says during this period, he noticed that one of the inefficient processes pertained to the drug discovery field. Mr Deshpande interacted with a group of scientists whose primary focus was to convert complex algorithms into software, which could then be applied to telecom. He understood the co-relation between businesses and information technology, and the role of the latter in preempting failure and help to save on finances. He then came up with a business case to get funding from the Mahindra-British Telecom corpus. But when they chose to focus on telecom, Mr Deshpande did not give up on his dream. He discussed his plans with the same team of scientists who had sown the seeds of his business venture. His communication skills helped him a lot. According to his team members, he is a â€œbrilliant communicator and possesses enormous energy to present his viewsâ€?. "The most appealing quality is that he brings in significant positive energy during any discussion or meeting. He has the unique ability to convince persons interacting with him with his view points. He is very vocal about his views on any matter and is also a good listener. He also constantly encourages creation of intellectual property for the company" Dr Sudhir A Kulkarni vice president, discovery, VLife Sciences Technologies Dr Atul Aslekar, who is now the director of VLife Sciences Technologies, was then based out of Japan and keen to return to India. â€œI told him about my plans and with him came the first set of funds. We put in our savings as seed capital for our company. The total seed capital, including those from angel investors, was 2.5 crore,â€? he says. In 2002, Vlife Sciences came into being with the core team comprising Mr Deshpande, Dr Aslekar and Dr Sudhir A Kulkarni, who is now vice president, discovery, of the company. The company recently appointed Ms Yogini Garud as the head of finance when they realized that the purse strings of the company needed to be handled by a different person. The journey towards success Like any other company, VLife rolled out its business with service-based projects that continued till 2006, as the concept of computational biology was still in its infancy in India. Prominent clientele in the initial years included Glenmark and Reliance for their polymers business. In 2006, the company received its first round of private equity funding from Kotak Private Equity Group (India Growth Fund). The team then started prototyping technology and invested the money to use this technology to create their own intellectual property for drug discovery. Since the beginning, Mr Deshpande never felt the need to depend on external sources, except for experimental studies. Today, all the tools and and intellectual property belongs to the VLife Sciences team. "Supreet is meticulous, full of confidence and extremely focused. Despite being an engineer and not being from the field, he has taken the company on a good growth path, raising funds from investors and has an extremely good team in place. The drug on diabetes ulcer is relevant in the Indian context, and it is commendable that a company of their size can take a candidate right up to clinical trials in such a short span of time. His case should be a learning lesson for all small entrepreneurs. It is not just funds that are important for the success of a venture, but a fantastic idea and business plan is also important" Mr Vishal Gandhi vice president-life sciences & technology, Yes Bank In 2008, when the company had some discoveries, and software technologies were finding customers, Mr Deshpande decided to separate the discovery division into a separate company called NovaLead Pharma. Kotak was given the same percent of holdings in NovaLead as VLife Sciences. Kotak has 23 per cent stake in both the companies. When discoveries at NovaLead reached a significant stage, the company raised more funds. Though Kotak showed interests, the company looked at other investors. â€œTata Capital came on board NovaLead with a fund of 25 crore, but we took only 13 crore from them,â€? says Mr Deshpande. The company raised funding to the tune of 22 crore in eight years and was able to develop eight drug candidates, of which one has reached the human clinical trial stage. The company has been reporting profits for the past four years clocking revenue of 1.5 crore year-on-year by licensing technologies and servicing projects. "Supreet is a passionate entrepreneur with a clear vision. Though by profession he is an engineer, he is heading technology and research company and I experience his amazing knowledge in legal and commercial field with complete outside the box thinking. I think the research work undertaken by him and his company should be recognized as social entrepreneurship rather than a commercial venture" Ms Yogini Garud head, finance, NovaLead Pharma He believes that willingness of investors to take risk by investing in a start-up is critical. â€œI can never say that my investors never took risk. Mr Nitin Deshmukh of Kotak had the courage to take risk in a business like ours. Same for Tata Capital,â€? he says. â€œWhen Mr Deshmukh came in, our technology was just a thought. There were no such companies operating in India in this field. There were no academic institutes doing such activities in India during that time.â€? Business strategy Today, the company looks at three forms of revenue streams, namely licensing of technology, servicing for a fee and investing in developing intellectual property (at NovaLead). The innovative part here is that licensing of technology to scientists can span from one year to five years or can be as short term as a week depending on the customers' demands. â€œOur idea is to enhance the return of investments for the pharma and research companies. There is no point burdening a company with a technology that will become obsolete after some time,â€? explains Mr Deshpande. "In my opinion, Supreet has a unique and interesting blend of passion, perfectionism and perseverance in his personality. This coupled with an inspiring vision makes him an excellent leader. With an astute eye for details, Supreet has a good hands-on approach for organizational management. He has the creative mind of an artist that brings a new dimension. He tackles the business challenges head on and has an ability to maneuver testing situations" Dr Atul Aslekar director, VLife Sciences Technologies The company has eight candidates in the pipeline. With new chemical entity (NCE) research being a high risk business, the company follows the drug re-purposing pathway, which is looking at identifying different therapeutic indications for an existing drug already approved by the USFDA. The lead candidate Galnobax for diabetic foot ulcers is entering human trial stage, while others are in different stages of validation. The idea is that by the time Galnobax passes phase I trials, other candidates will hit clinical trials. The market size for this product is between $8-$20 billion. The global diabetic population is estimated to hit 285 million by 2025, out of which 15 percent will have foot ulcers at least once in their life time. Human data for Galnobax would be available by December 2012 that will decide whether the company can become a billion dollar company in the next two years. The next lead candidate is an anti-wrinkle application for age-related wrinkles. â€œThe strength of each candidate is very important and you just cannot look at one candidate,â€? he says. "Supreet is a strategic visionary with creative genius and an inspiring and passionate leader. His desire to achieve perfection and the best in technology is limitless. He is demanding and leads from the front." Mr Kamlakar Jadhav VP, technology, VLife Sciences Technologies Pillars of success Besides the core team, Mr Deshpande attributes the success of the company to his employees. â€œWhen we set up the company, we had young talent who came on board and have now become pillars of our research and technology work,â€? he asserts. To keep up the interest in research among his team members and to retain them, Mr Deshpande mooted a novel initiative by setting aside a certain sum of money for â€œscientific questsâ€? that may or may not translate into revenues. The company now has 18 people. Mr Deshpande says that he does not expect the total strength to go beyond 50, even when the company is at its peak. â€œOur business is not headcount-oriented but resource-oriented.â€? The vision His vision for the company is that all stakeholders should get their return. The patient should get the end-benefit, the company licensing the product should not lose money, service providers should get a fair deal, stakeholders (employees) should have confidence and a sense of ownership towards the company and investors should get a fair return on their investments. Mr Deshpande also believes that an entrepreneur should have an open mind to question and learn from his colleagues. â€œSuccess or failure is never in our hands. But doing the work whole heartedly is in our hands. That's what makes a difference,â€? he concludes. -Nayantara Som in Pune ]]> <![CDATA[BioSpectrum Awards 2011]]> https://biospectrumindia.com/news/95/2342/biospectrum-awards-2011.html https://biospectrumindia.com/news/95/2342/biospectrum-awards-2011.html Fri, 09 Dec 2011 16:13:00 +0530 2003 Person of the Year Dr Kiran Mazumdar-Shaw Lifetime Contribution Prof MS Swaminathan Entrepreneur of the Year Dr Krishna M Ella Product of the Year AVADIS Special Category Award Andhra Pradesh 2004 Person of the Year Dr Cyrus S Lifetime Contribution Dr Manju Sharma Entrepreneur of the Year Dr KK Narayanan Product of the Year JEV Chex 2005 Person of the Year Dr MK Bhan Lifetime Contribution Dr NK Ganguly Entrepreneur of the Year Mr Sudhir Pai J Product of the Year Q-Vac Product of the Year Shantetra 2006 Person of the Year Mr M Ramasami Lifetime Contribution Dr RA Mashelkar Entrepreneur of the Year Dr Villoo Morawala-Patell Product of the Year Reliance's plasma proteins Special Category Award Mr Kapil Sibal, Leadership Award in BT 2007 Person of the Year Mr Varaprasad Reddy Lifetime Contribution Dr Pushpa Mittra Bhargava Entrepreneur of the Year Dr Vijay Chandru Product of the Year BIOMAb EGFR Special Category Award Gujarat 2008 Person of the Year Prof Samir K Brahmachari Lifetime Contribution Prof G Padmanaban Entrepreneur of the Year Ms Anuradha Acharya Product of the Year XCyto Screen Product of the Year Reditux 2009 Person of the Year Mr Hari Bhartia Lifetime Contribution Prof D Balasubramanian Entrepreneur of the Year Mr Apruva Shah Product of the Year Dry Tri T-stat 2010 Person of the Year Mr Glenn Saldahna Lifetime Contribution Prof Obaid Siddiqi Entrepreneur of the Year Dr Rashmi Barbhaiya Product of the Year CRY1C bt gene State of the year Karnataka ]]> <![CDATA['We are open to affordable outright acquisition options']]> https://biospectrumindia.com/news/95/2573/we-are-open-to-affordable-outright-acquisition-options.html https://biospectrumindia.com/news/95/2573/we-are-open-to-affordable-outright-acquisition-options.html Fri, 09 Dec 2011 16:07:00 +0530 Mr Anandh Balasundaram MD, AstraZeneca Pharma India In October 2011, AstraZeneca made news for its record investment of $200 million in China for tapping its burgeoning market. Now, the company is focusing on India by investing heavily in tuberculosis research, increasing employee headcount and maintaining consistency in product launches in the country. In a conversation with BioSpectrum, Mr Anandh Balasundaram, managing director, AstraZeneca Pharma India, throws light on the company's game plan for India, views on acquisition and the need for an MNC to keep a balance between affordability and return of investments. Q   Presently, what is AstraZeneca's strategy for India? How are you looking at growing the business in the country? Mr Balasundaram: AstraZeneca has an integrated presence in India that covers the entire spectrum, ranging from discovery, R&D, manufacturing, operations, global external sourcing and branded generics to sales and marketing. Our intention is to increase business in India by marketing our originator products, high quality branded generics, innovator patent products and expand our field force as per market requirements. Simultaneously, we are looking at inorganic opportunities to augment the scale in India. Q   How significant is India in particular and the emerging markets as a whole in AstraZeneca's overall global strategy? Mr Balasundaram: Emerging markets are important areas of focus for AstraZeneca. In 2010, emerging market's revenue accounted for nearly 57 percent of the total sales growth outside the US for AstraZeneca. According to world pharmaceutical market figures, average revenue growth in emerging markets was nearly 14 percent in 2010, more than three times the rate in established markets. It has also been estimated that emerging markets will contribute around 70 percent of pharmaceutical industry growth in the next five years. Furthermore, faster-developing economies, such as China, India and Brazil, offer new opportunities to the industry in order to help an expanding number of patients who can benefit from medicines. Emerging markets now represent approximately 85 percent of the world population. According to IMS Health, the estimated pharmaceutical market growth in India is expected to be 14.2 percent between 2009 and 2014. Keeping these opportunities in mind, AstraZeneca is focused on expanding in the emerging markets, both through organic growth of products from our current portfolio and pipeline and also through selective additions of AstraZeneca's branded generics. In 2010, we identified a portfolio of more than 100 generic products, that we are currently licensing across 30 emerging markets. To help us license these dossiers and source the molecules, we are working with a number of companies in India, which includes an agreement with Torrent, for aiding in the supply of a portfolio of branded generic medicines. Q   Given the opportunities in India, which therapeutic segments will AstraZeneca focus on in the coming months? Mr Balasundaram: We believe that India will be one of the top five markets for any pharmaceutical company over the next 10 years. The market will be driven by the growing middle class, increased spending on healthcare, insurance and treatment. Our existing originator products, branded generics and innovator products offer a large opportunity. We plan to leverage these offerings while formulating India-specific strategies, keeping the patient in mind. Q   Kindly throw some light on AstraZeneca's tuberculosis research center in India? How important is this center for the company globally? Mr Balasundaram: AstraZeneca's discovery research center in Bangalore is part of our global infection innovative medicines unit focused on tuberculosis (TB) research and other diseases found primarily in the developing world. The team is collaborating with leading names in their respective fields to meet this objective. We have delivered a candidate drug to treat TB in both its drug-sensitive and drug-resistant forms, which also offers the potential to shorten the duration of therapy. The compound is in phase II clinical trials. In addition to TB research, the team supports our antibacterial discovery efforts in close collaboration with colleagues at AstraZeneca's R&D site in Massachusetts, US. Q   What investments has the company made in India in terms of infrastructure, manpower and funds? Mr Balasundaram: AstraZeneca in India has grown from 500 to 1,500 employees in the last four years, and this is largely fueled by the growth in the field force. We expect to continue investments in our field force as per market requirements. We also intend to continue to drive growth of our brands by investing and providing scientific education to doctors in the therapy areas that we serve. Our investments in India include $20 million initial investment in the TB research center in Bangalore and $22 million in our pharmaceutical formulation and development center. We are also investing about $17 million in a new world-class tablet facility. In addition to this, we have created a sourcing center and a separate facility for the branded generics team that would help serve markets across the world. Q   Which products will AstraZeneca introduce in India from its global portfolio in the coming months? Mr Balasundaram: Last year, we successfully introduced Onglyza in India through a global collaboration with Bristol-Myers Squibb. We have filed for approval for Brilinta in India. Our ambition is to launch innovator products in India as close to its global introduction as possible. Q   At what price points will these products be marketed? How is AstraZeneca looking at making its products more affordable in India? Mr Balasundaram: AstraZeneca will assess the market opportunity for any product that it plans to bring to India and accordingly evaluate price points. Our intention has always been to provide our customers with quality medicine at affordable prices. For example, our India pricing for Onglyza is among the lowest in the world. However, we must remember that launching an innovator product involves millions of dollars on R&D and that there needs to be a balance between affordability and sufficient return in order to sustain continued investment in research. Q   Like other MNCs, is AstraZeneca looking at large scale acquisitions and alliances with domestic companies? Mr Balasundaram: At this stage, taking expensive valuations into consideration, AstraZeneca believes that the best way to augment scale in India and grow our footprint is through alliances and partnerships that offer complementary skills or products. However, we remain open to affordable, outright acquisition options that may come up. Q   How will the European debt crisis affect MNCs operating out of India? Will it affect AstraZeneca's operations in India? Mr Balasundaram: We do not see any direct effect on AstraZeneca's operations in India at this point, but we will continue to evaluate the situation. Q   What investments will the company make in the coming months in manpower and infrastructure? Mr Balasundaram: As previously mentioned, AstraZeneca has currently invested about $17 million in a new world-class tablet facility, which we hope to make operational in 2012. We will also continue to increase the size of our field force as required for launch of new products. Q   What is your target market share and growth rate (in India) in the coming months? Mr Balasundaram: AstraZeneca is one of the fastest growing multinational companies in India and we aim to maintain a growth rate that is clearly in excess of the market in the years to come. Nayantara Som in Mumbai ]]> <![CDATA['Competition will make Indian suppliers more professional']]> https://biospectrumindia.com/news/95/6441/competition-will-make-indian-suppliers-more-professional.html https://biospectrumindia.com/news/95/6441/competition-will-make-indian-suppliers-more-professional.html Fri, 09 Dec 2011 16:06:00 +0530 Mr Arun Prakash MD, Genetix Biotech Asia For almost two decades, New Delhi-based Genetix Biotech Asia has been involved in the distribution of life sciences research products to public and private sector institutes. Recently, the company changed its strategy and is focusing more on manufacturing and promotion of its own brand in the India market. In an interaction with BioSpectrum, Mr Arun Prakash, managing director, Genetix Biotech Asia, spoke on the latest developments in the company, challenges before it, competition and the latest trends in the biotech industry. Q   How has the growth of Genetix Biotech been since inception? When we started in 1991, we were a small part of this whole biosupplier industry. Now, 55 percent of the company's revenue comes from the biopharma industry. From being mere distributors, we have come a long way by re-branding ourselves as both distributors and manufacturers of indigenous products. During the last two years, our business was consolidated to a great extent and we are improving our infrastructure. Q   How do you see the competition in the biosupplier industry? The competition is forcing companies to change their strategies and move towards becoming more professional. The recent acquisitions of the Indian supplier companies by multinationals based in the US has added to the direct competition between Indian and foreign companies. Although more than 60 percent of our business was initially affected by this, we are sure that it will not hold ground for long as providing services to clients in India is a different ball game. On a positive note, I still feel that it is an opportunity for us to come up with new range of products. With this competition, there will be a major change in the way business is done in India. Q   According to you, what are the major challenges before the biosupplier companies? Logistics continues to be a major issue in India. In the last 20 years, we managed the things on our own by having warehouses and doing business with a lot of risks. Earlier, there were heavy taxes but over the period, they have come down. The transportation and lack of proper storage facilities at airports and clearances of certain temperature-sensitive products add to the woes of distributors. I hope that in future we will be able to overcome these challenges. The latest challenge is the direct entry of US companies, which has taken away business of many primary distributors. But it is also now visible from customer feedback that these companies have not been able to do justice to customer service. It is not so easy to just walk into a country and start selling. In the Indian scenario, face value and personal contacts matter a lot. The big companies generally don't care about individual concerns on products. Therefore, I still believe that distributor companies play an important role here. Q   What are your future plans? Though we have not entered into any new collaborations yet, we will continue to focus on the distribution business. At the same time, we will also give ample attention to our manufacturing business. We have invested significantly to the tune of 10.4 crore ($2 million) in product development and in making our products more acceptable. As we have a good presence in the market, we are now focusing on generating 50 percent of our business revenue from our own 'Genetix' brand. In fact, we have tied up with a few companies to promote our brand in the other Asia Pacific countries. We established an R&D center in Delhi and one manufacturing unit in Dehradun. Since we already have enough access to the market, we will keep reaching out to potential clients. Q   How do you visualize the growth of biotechnology industry in India? In my opinion, the industry in India has still not grown to a significant size as compared to other global markets. The reason behind this is the lack of special consideration for the industry here. In India, the biotechnology industry is treated like any other industry and that makes it difficult to run things smoothly. Besides, the government has also not encouraged the industry to the extent that it should have. Of course, there have been continuous funding for research activities, but the requirements of the industry also need to be fulfilled. The industry needs subsidized raw material and customized warehouses at airports. China and other developing countries are making special considerations for the biotech industry, which is driving the growth of the industry there. -Rahul Koul in New Delhi ]]> <![CDATA['We're expanding to Australia, Sri Lanka by 2012']]> https://biospectrumindia.com/news/95/2707/were-expanding-to-australia-sri-lanka-by-2012.html https://biospectrumindia.com/news/95/2707/were-expanding-to-australia-sri-lanka-by-2012.html Fri, 09 Dec 2011 16:04:00 +0530 Dr Biswajit Roy CEO, Chromous Biotech Chromous Biotech, which recorded revenues of 12 crore this year, was started in 2006 as a supplier of molecular biology products. It has since expanded into contract research and research and development of diagnostic kits. In an interview with BioSpectrum, Dr Biswajit Roy, CEO of Chromous Biotech, traces the company's journey so far and talks about the challenges faced by them. Q   What strategies did you adopt to counter multinational companies? One of the biggest challenges we faced was the importance scientists placed on brand names that they have been using since their doctorate days. It has been a slow and tedious process, but we are now finally overcoming this problem. Brand establishment is a time-consuming process and there is no short-cut. The sales are directly proportional to the level of acceptance and by this estimate, we have achieved what other companies have, but in half the time. We are growing fast but there is a level of skepticism among scientists, which we hope to counter with time. Q   Tell us about your product range. We focus on all products required for molecular biology experiments, which include biologically active enzymes and other non-perishable entities. We have developed a mutant, Taq polymerase, which reduces the time for a PCR reaction from two-to-three hours to 22 minutes, for which a patent is pending. This has a broad range of applications in microbiology, molecular diagnostics and other forms of research. Also, we offer columns for DNA isolation at a fraction of the market price, allowing scientists to make their own solutions from material available in their labs, which reduces the cost from 300-400 to 40 for a column. Q   How would you describe your client base? Around 70 percent of our clients comprise scientists from government institutes, such as the NCBS, Bangalore, and NIO, Goa, and around 15 percent are from educational organizations. The rest are from private companies, such as Lupin, Astra Zeneca and Natco Pharma. Q   What strategies did you employ to set yourself apart from competitors? We are the first in the biotech industry to introduce flexi systems in terms of quantity. Distributors tend to group large orders together for imports, which result in delays. We wanted to leverage the fact that we are an Indian molecular biology manufacturer and hence can avoid the problems of delays and high costs of shipment associated with other companies. People can order reagents according to their required quantities with us and be assured of a delivery within 24 hours of the order. Flexi packs have been very well received. They constitute around 60 percent of our product orders. Q   How spread out is your marketing network? We have seven regional heads operating out of the major cities in India who are working with 53 distributors. We have marketing offices in the UK, and are starting offices in Australia and Sri Lanka by early 2012. Q   What are your future plans for the company? We have observed that this market is very fragmented, hence we are trying to integrate all activities under one roof. We have just ventured into the plastics market. Also, we are starting a new range of low-technology basic laboratory instruments, such as sonicators, vortexes and gel electrophoresis units. These are being produced in India at plants certified by the National Accreditation Board for Testing and Calibration Laboratories. They will offer tremendous cost advantage over their international counterparts. With this, we are widening our target market size to 500 crore and hope to achieve revenue target of 50 crore in the next three years. We have funds of around 3 crore under the Department of Biotechnology's Biotechnology Industry Partnership Programme and the DSIR for development of kits for malaria and tuberculosis. Manasi Vaidya in Bangalore ]]> <![CDATA[Stempeucel trial: A landmark in stem cell therapy]]> https://biospectrumindia.com/news/95/1716/stempeucel-trial-a-landmark-in-stem-cell-therapy.html https://biospectrumindia.com/news/95/1716/stempeucel-trial-a-landmark-in-stem-cell-therapy.html Fri, 09 Dec 2011 16:01:00 +0530 Stempeutics starts phase II clinical trial of the first-of-its-kind product, stempeucel, for treating patients suffering from alcoholic liver cirrhosis. The Department of Biotechnology will fund up to 3.5 crore towards this trial, while Stempeutics' contribution is estimated to be approximately 5 crore Bangalore-based stem cell company of Manipal Education and Medical Group, Stempeutics Research, announced commencement of phase II clinical trials of its investigational medicinal product, stempeucel, in patients suffering from alcoholic liver cirrhosis. Stempeucel is developed from allogeneic mesenchymal stem cells derived from donated bone marrow using Stempeutics' proprietary technology. Towards this landmark trial, the company has received funding from the Department of Biotechnology (DBT) under the Biotechnology Industry Partnership Program (BIPP). The trial will be funded jointly by Stempeutics and the DBT. The primary objective of this clinical trial is to assess the safety following a single administration of different doses of stempeucel via the percutaneous puncture of the femoral artery, followed by selective cannulation of the hepatic artery (Seldinger Technique) in liver cirrhosis patients. The secondary objective is to explore the efficacy by assessing the potential of allogeneic mesenchymal stem cells in order to improve the liver function and quality of life in liver cirrhosis patients, and to find the suitable dose of allogeneic mesenchymal stem cells in order to improve their liver function and quality of life. Success of this project will help India to become one of the leading countries after the US to develop stem cell-based drugs for unmet medical needs like liver cirrhosis. So far, so good Towards the beginning of 2011, Stempeutics received The Drug Controller General of India's (DCGI) clearance for conducting phase II clinical trials for Stempeucel to treat four debilitating diseases. This would be a multicentric, placebo controlled, double blind, allogeneic clinical trials addressing osteoarthritis, liver cirrhosis, diabetes mellitus type 2 and chronic obstructive pulmonary disease. Being the first-of-its-kind stem cell product developed in India, it took almost 15 months to get the DCGI's clearance. The DCGI referred Stempeutics' proposal to the Indian Council for Medical Research (ICMR) for review and recommendation. The ICMR constituted an expert stem cell committee to examine the proposal and the committee accepted the study as phase II clinical trials. Other companies in India that have made news in the stem cell therapy forefront in the recent years include Reliance Life Sciences (RLS). RLS has established the safety and efficacy of stem cell therapies of autologous bone marrow derived mesenchymal stem cells for cardiac disorders (CardioRel), neurological disorders (NeuroRel), autologous melanocytes grafts for stable vitiligo (ReliDerm M) and allogeneic fibroblast graft for diabetic foot ulcers (ReliDerm DT). For stempeucel, while the DBT will be funding up to 3.5 crore towards this trial, officials from Stempeutics mentioned that it would look at an estimated contribution of 5 crore. Financial backing by the DBT for this initiative, spells good news for the stem cell industry in India, which has been battling paucity of funds to bolster research initiatives. Dr B N Manohar, CEO, Stempeutics Research, says, â€œOnce phase II trial is successfully completed, the company will be approaching the DBT for phase III clinical trial funding under Biotechnology Industry Partnership Program (BIPP). This phase of the trial shall be completed by December 2012. Overall, 60 patients shall be recruited in five hospitals all across India.â€? In addition to this, a core team of five members will work on this product development from Stempeutics. â€œCore team consists of scientists, medical doctors, pharmacist and production technologist. Apart from the Stempeutics team, principal investigators from five hospitals will be involved in conducting the clinical trial,â€? added Dr Manohar. The investigational medicinal product for clinical trial is being manufactured at the Manipal facility as per Good Manufacturing Practices (GMP) guidelines. The approximate size of the facility is 7,000 sq ft and it has been audited by a DCGI team for GMP compliance. Once the product is ready, it will be marketed by Cipla. As far as commercialization is concerned, company officials claim that it is too early to put definite timelines on these points. â€œWe will be in a better position to address this after the phase II trial is completed. The product will be marketed first in India and subsequently in neighbouring countries,â€? adds Manohar. Market potential of product According to market figures brought out by Frost and Sullivan, the estimated market size for stem cell therapy in India for various indications is approximately 2,700 crore. Out of this total addressable market, the market size for liver cirrhosis is approximately 400 crore. The size of the alcoholic population in India has also increased over the years. Prevalence of alcoholics in India is found to be 21 percent in adult males. This ranges from as low as seven percent in Gujarat to 75 percent in north eastern part of India. Alcoholic cirrhosis develops in 15 percent of individuals who drink heavily for more than a decade. Generally, liver damage from cirrhosis cannot be reversed and one can only delay further progression and reduce complications by conservative management. When complications cannot be controlled or when the liver becomes extremely damaged from scarring or fibrosis, then it completely stops functioning, orthotopic liver transplantation (OLT) becomes necessary and is considered the standard treatment for advanced decompensated liver cirrhosis. However, the OLT cost is very expensive and moreover it is very difficult to get HLA-matched donors. It is envisaged that stem cells can help to repair and regenerate the damaged liver, thus decreasing the requirement of OLT and provide therapeutic benefit to patients. Says Dr Manohar, â€œGlobally, until date, no stem cell product has been marketed for liver cirrhosis, but few global clinical trials have been conducted using both mononuclear stem cells and mesenchymal stem cells. It has shown that these cells are safe and that they improve the liver function in these groups of patients.â€? Whilst the promise of regenerative medicine has been given thumbs up by the industry, experts like Dr Samuel J K Abraham, director, Nichi-In Center for Regenerative Medicine (NCRM), puts in a word of caution with respect to allogenic and mesenchymal stem cells. â€œIn my personal opinion, autologous cells for primary organ failures are acceptable, as several studies confirm the safety exist.When we go for allogeneic, we need to be very careful. Moreover, if one source of allogeneic donor stem cells is administered, and if the patient needs subsequent injection, it should be from the same donor. For this, the donor must be willing to donate or his earlier stem cells must be available for the subsequent administration to the patient. Otherwise by injecting another allogeneic source of cells, what will be the outcome is a question that remains to be answered,â€? he adds. With regards to mesenchymal stem cells, says Dr Satyen Sanghvi, chief scientific officer, Regenerative Medical Services (RMS), â€œBone Marrow MSC transplantation has been the gold standard treatment option for bone conditions such as avascular necrosis and non-uniting or malunion fractures. Other research using bone marrow MSCs involves the application of cultured or uncultured (directly from bone marrow) cells in cardiac conditions. Several clinical trials are being carried out in many countries where doctors are performing these procedures with patient consent since the regulatory framework is non-existent. MSC application must be targeted to conditions where enough in vitro (lab), and in vivo (in animal & human) data is present and better understanding of the indication-cell type needs to be fostered.â€? -Nayantara Som in Mumbai ]]> <![CDATA[Sanofi dengue vaccine trial enters phase II]]> https://biospectrumindia.com/news/95/1495/sanofi-dengue-vaccine-trial-enters-phase-ii.html https://biospectrumindia.com/news/95/1495/sanofi-dengue-vaccine-trial-enters-phase-ii.html Fri, 09 Dec 2011 15:44:00 +0530 The approval for phase II clinical trials of tetravalent dengue vaccine to Sanofi Pasteur India has raised India's hopes to have a vaccine to fight the disease In October 2011, the Genetic Engineering Appraisal Committee (GEAC) gave a go-ahead to Mumbai-based Sanofi Pasteur India to import a dengue vaccine from Sanofi Pasteur, France. The company will study immunogenicity and safety of the vaccine on Indian population under Protocol No CYD 47. The GEAC's decision was based on the recommendation of the Drug Controller General of India (DCGI) and other experts who favored the proposal to conduct phase II clinical trials for this vaccine. When Sanofi Pasteur approached the DCGI for permission, the regulatory body had referred the case to its Investigations New Drug Committee. After a go-ahead by the committee, the company approached the GEAC early in 2011. Worldwide, an estimated 50 million dengue infections occur annually, with approximately 500,000 cases of severe dengue and 20,000 deaths. Currently, there is no vaccine available for dengue fever caused by viruses carried by the Aedes mosquito. The disease is caused by any one of the four closely related, yet antigenically distinct, dengue viruses (DENV-1, DENV-2, DENV-3 and DENV-4) of the family. This candidate vaccine from Sanofi targets all four virus serotypes circulating in the US, Asia and Latin America. Clinical studies (phase III) among adults and children are now on in Mexico, Columbia, Honduras, Puerto Rico, Peru, Phillipines, Vietnam, Singapore, Australia and Thailand. The vaccine has reportedly shown over 90 percent safety and efficacy profile during the phase II trials that were done in various other countries. Currently, an efficacy trial of the three-shot vaccine is going on in Thailand on 4,000 children and it will be a critical milestone in its development. Data is expected to be available by the end of 2012. In India, Sanofi is expected to do trials initially on the two-to-45 years age group and after the review of results, on those between nine months and 65 years. If everything goes well, the vaccine could possibly be available in the market by 2015 or 2016. According to Dr P L Joshi, faculty, National Institute for Health and Family Welfare, New Delhi, who is on the Indian Council of Medical Research panel of experts in the field of leprosy and vector borne diseases, â€œThe mortality rate for dengue can be reduced considerably if self mangement practices are followed. Being a vector borne disease, the success of dengue control also depends highly on the environment policy.'' There are other ongoing efforts to develop a vaccine indigenously in India. The National Institute of Allergy & Infectious Disease, Laboratory of Infectious Diseases has licensed a deletion/chimeric technology to Biological E and Panacea Biotec to move a dengue vaccine forward for product registration. There is a tendency among the live viruses in the tetravalent vaccine to interfere with each other and that has led to the emphasis on the need to develop non-infectious dengue vaccines as safer alternatives. Dr Rajesh Jain, MD, Panacea Biotec, says, â€œThis is an important development and let us hope that it will be significant in terms of safety and cost-effectiveness. The need for an indigenous vaccine in India is due to the lack of accessibility and affordability that plays an important role here.'' â€œIt has huge economic and social consequences,'' agrees Dr M K Bhan, secretary, DBT, and adds, â€œMillions of dollars have been spent on the dengue vaccine intitiatives and everybody is looking forward to an early breakthrough. We should have an indigenous vaccine as soon as possible.'' Appreciating the efforts of the International Center for Genetic Engineering and Biotechnology (ICGEB), New Delhi, Dr Bhan says, â€œThey are developing a non-infectious dengue vaccine based on the well-established hepatitis B vaccine technology with the help of National Institutes of Health. The program led by Dr Navin Khanna is promising and we expect the trials to be done soon.'' Currently, the Recombinant Gene Products Group at the ICGEB is developing sub-unit vaccines, based on the DENV envelope protein domain III, which mediates virus entry into cells and elicits virus-neutralizing antibodies. Their research activities are focused towards the development of experimental dengue tetravalent sub-unit vaccine in yeast. In consultation with the Indo-US Vaccine Action Program, the ICGEB has created DENV-2 EDIII HBsAg virus-like particles and is currently evaluating them physically and functionally. According to Dr Virander Chauhan, director, ICGEB, â€œThis is indeed a great step forward as having more options to tackle dengue are always welcome. Meanwhile, the ICGEB is also moving ahead with its vaccine program and the results, so far, have been very encouraging.'' About half of the estimated 2.5 billion people across the globe who are at risk of infection reside in India. This makes a dengue vaccine an absolute requirement for the country. Therefore, positive results from Sanofi vaccine trials will be a great development. Additionally, an indigenously developed vaccine will prove to be more affordable and will have a broader reach. Rahul Koul in New Delhi ]]> <![CDATA[Fresh hopes emerge in AIDS vaccine research]]> https://biospectrumindia.com/news/95/2422/fresh-hopes-emerge-in-aids-vaccine-research.html https://biospectrumindia.com/news/95/2422/fresh-hopes-emerge-in-aids-vaccine-research.html Fri, 09 Dec 2011 15:36:00 +0530 The structural characterization of a number of broadly neutralizing antibodies has boosted the efforts to tame the highly mutable HIV virus, thus raising hopes for an AIDS vaccine after years of trial and error in the field Is there a magic protein out there that will neutralize the HIV virus? That is the question plaguing scientists like Dr Wayne Koff. He is the chief scientific officer at the International AIDS Vaccine Initiative (IAVI) and has worked on the HIV virus since the time be began his career, almost 25 years ago. Recently, in India, at the invitation of the Department of Biotechnology to participate in the symposium titled â€œvaccines-from discovery to translationâ€? Dr Koff was involved in deliberations with 100 other experts from the field of vaccinology. "Broadly neutralizing antibodies have the ability to neutralize varied forms of the HIV virus and thus exhibit cross reactivity between diverse genetic subtypes." Dr Wayne C Koff CSO and senior vice president, IAVI Given the variability of the HIV virus, developing a vaccine for HIV is a tough challenge. The virus integrates and hijacks the host genome and induces latency. Also, immune responses in case of HIV infection are inadequate and ineffective and are not fully known. The development is based on the HIV envelope proteins, which are exposed to the immune system, that mainly comprise one large protein called gp120. Initially, vaccines were targeted against gp120 and intended to generate antibodies against HIV-1 envelope to neutralize the virus. According to experts, till October 2011, 168 clinical trials have been completed using about 42 vaccine candidates. These include peptide immunogens, VLPs, purified HIV-1 envelope proteins (gp120), HIV-1 plasmid DNA encoding viral proteins, HIV-1 proteins (gag/pol/env) and viral vectors. The highly mutable virus has so far eluded all efforts to tame it. The big question is on the mutability part of HIV and the length of dendrograms also adds to the variability factor. The HIV virus, through a number of conformational changes, denies a neutralizing antibody response. RV 144 boosts hope Hope came in the form of RV 144 vaccine trial that involved 16,000 volunteers in Thailand. The RV144 vaccine is also a viral vector prime and recombinant gp120 protein boost that has shown an efficacy of 31 percent. Result of the immune correlate study, recently declared at the AIDS 2011 conference, indicate a possible protective role of antibodies against the V1/V2 loop of gp120 in uninfected participants. While the results generated only 30 percent protection and is considered not satisfactory, it has demonstrated for the first time that a vaccine can indeed protect humans from HIV infection. "I think a first generation vaccine would be available by 2020, and the second-generation vaccine by 2025." Dr David N Cook executive vice president & COO, IAVI Besides, the structural characterization of a number of broadly neutralizing antibodies has boosted the vaccine development efforts. â€œIt was reported that certain individuals infected with HIV did not show any symptoms of AIDS. These elite protectors who had been living with the virus for almost 20 years without the disease were found to contain broadly neutralizing antibodies (bNAbs) that were isolated and their structures were determined by X-ray crystallography,â€? informs Dr Koff of IAVI. â€œbNAbs have the ability to neutralize varied forms of the HIV virus and thus exhibit cross reactivity between diverse genetic subtypes.â€? Dr Koff elaborates, â€œThe antigen bound structures of the bNAbs provided precise information as to how the bNAbs recognized and interacted with their antigens. Based on this structure information, scientists across the world, including India, are attempting to design immunogens that can elicit bNAbs.â€? The antibody neutralizing trials project involves Africa, India and Australia in a major way. Currently, there are 10,031 GCP trained employees, 350 sites and 18 clinical accredited labs working under the IAVI consortium. Also, around 200,000 people have received training and consultation in HIV/AIDS by the organization. Dr Rajat Goyal, country director India, IAVI 'THSTI-IAVI program is looking for lab director' The International AIDS Vaccine Initiative (IAVI) is playing an important role globally to bring together various organizations to partner on vaccine research. The organization has major presence in countries like the US, Africa, India and Australia. At the IAVI India, Dr Rajat Goyal provides strategic direction to the country program. The India program has garnered strong national and state support and has an extensive program of information dissemination, community involvement and AIDS vaccine trial site preparedness activities. In an informal chat with BioSpectrum, Dr Goyal elaborates on the Translational Health Science & Technology Institute (THSTI) project. Can you elaborate on the THSTI project? Launched in early 2011, the HIV Vaccine Design Program in India, is jointly established, operated and funded by the Gurgaon-based Translational Health Sciences and Technology Institute (THSTI) and the International AIDS Vaccine Initiative (IAVI). The program will capitalize on recent research advances that have sparked a renaissance in AIDS vaccine R&D. The focus of the program will be on one of the greatest scientific challenges of AIDS vaccine design and development: the elicitation of antibodies capable of neutralizing a broad spectrum of circulating HIV variants, a problem that stems in large part from the almost unparalleled mutability of HIV. The IAVI-THSTI collaborative program will participate in a coordinated, global effort to create replicas of bNAb targets in the laboratory for use as immunogens, which are the active ingredients of vaccines. This program will be charged with the complex task of developing, testing and then implementing strategies to rapidly screen large numbers of bNAb-based immunogens against HIV-1 and to prioritize them for further evaluation in preclinical studies. It is expected that the program using high throughput (HT) screening will ultimately lead to strategies for next generation immunogen design and expand the number of AIDS vaccine candidates available for assessment in human trial. At what stage is this project currently? The Translational Health Science & Technology Institute (THSTI) project has already started and we are in the process of hiring. It has 43 manpower positions, including administration staff. The appointments will be of a lab director, three principal investigator and 35 scientists. There is a lot on agenda. We will roll out the scientific plans in 2012. There has been a significant amount of funding from the government. Initially, the project is operating out of interim labs in Gurgaon, and will move to the Faridabad biocluster, once that is ready in 2015. The current focus is on creating infrastructure, lab and hiring. â€œCurrently, the screening under Protocol G, which is a large, multicenter effort to find new, naturally occurring antibodies capable of neutralizing a wide variety of HIV strains, is underway in African countries, US and Australia. The criteria for choosing individuals for trials include the condition that the persons must have remained healthy for at least three years after becoming infected and they should not be on anti-retroviral drugs,â€? says Dr Koff. â€œThe important finding is that the exact shape of the four binding sites is now known. The researchers are also exploring the possibilities of having more sites.â€? Dr David N Cook, executive vice president & chief operating officer, IAVI, says, â€œWith this development we have moved closer to the vaccine. I think first generation vaccine would be available by 2020, and the second-generation vaccine by 2025. The next milestone would be to test the vaccine candidate neutralizing antibodies in the animal model and the target for that is end of 2013 or early 2014. To get there, we need to screen hundreds of candidates each year. The problem is that in science the results cannot be predicted.â€? Talking about the efficacy of the vaccine, Dr Cook says, â€œThe 20-to-40 percent efficacy against the viruses is considered to be weak and between 60 and 80 percent can be considered to be effective. But in this case if efficacy is at 50 percent, then it may later rise to even 80 percent and then 90 percent with time. However, the vaccine having 50 percent efficacy will only work in some specific populations. The targeting of specific populations helps in terms of risk group identification and, therefore, is cost effective.â€? India rises to the challenge In India, efforts are on to bring industry and academia together in the field of vaccine R&D, and provide a scientific basis for vaccine design and development. The IAVI and the Department of Biotechnology (DBT), Ministry of Science & Technology, Government of India, have joined hands with the Vaccine Grand Challenge Program, Vaccine and Infectious Diseases Research Centre, Translational Health and Technology Institute and Clinical Development Services. This symposium was a part of that effort. The initiatives for structure-based immunogen design of HIV vaccine is globally supported by a neutralizing antibody consortium of the IAVI. Two Indian institutions, International Center for Genetic Engineering and Biotechnology (ICGEB), New Delhi, and the Indian Institute of Science (IISc), Bangalore, are active members of this consortium. The isolation of a large number of nABs from different HIV-infected donors provides proof-of-concept that such antibodies could be elicited in humans. Since classical approaches to produce protective antibodies have not been successful, the rational structure-based immunogen design seems to hold the key. The affected people have lesser copies of T cells. Lead Control is less than three percent of the affected population. Talking about the steps used to put all the discoveries together, Dr Cook says, â€œThe first is identification of antibody, the second one is elucidation of structure that it binds to and finally, the idea about how the immune response develops.â€? â€œThe deep sequencing technique has helped in finding how T cells and immune responses develop with time. It put us on the edge of developing the new vaccine,â€? Dr Cook adds, while appreciating the role played by technology. Due to the unavailability of a proper drug to treat AIDS, an HIV vaccine that can elicit enough immune responses to protect the host against the disease will certainly be of great benefit to mankind, as Antiretroviral Therapy (ART) can take us only so far. Rahul Koul & Nandita Singh in New Delhi ]]> <![CDATA[Jubilant's net profit rises by 8 percent]]> https://biospectrumindia.com/news/95/2423/jubilants-net-profit-rises-by-8-percent.html https://biospectrumindia.com/news/95/2423/jubilants-net-profit-rises-by-8-percent.html Fri, 09 Dec 2011 15:34:00 +0530 Jubilant Life Sciences declared its financial results for the second quarter of FY 2012 in which its revenue stood at 1,048 crore, up 22 percent year-on-year (YoY) and 11 percent quarter-on-quarter. In the quarter ending September 30, 2011, the company's earnings before interest, taxes, depreciation, and amortization (EBITDA) was 241 crore up 58 percent YoY with margins at 23 percent, as compared to 17.8 percent in Q2 FY11. Net profit for the quarter grew eight percent YoY and stood at 79 crore, after accounting for 43 crore mainly due to unrealized foreign exchange loss in Q2 FY12. During the quarter, the company signed a long term supply in life science ingredients business with a leading international life sciences company. The total value of this contract is in the range of 416-520 crore ($80-100 million), to be supplied in three years from the first quarter of FY13. Jubilant also signed a multi-year contract in contract manufacturing organization business with a leading US pharma company to manufacture a prominent over-the-counter women's health and personal care product in North America. It has recently entered into collaboration with Norgine, a leading European speciality pharmaceuticals company under its integrated drug discovery model, to provide pre-clinical candidates for developing multiple targets in gastrointestinal diseases for an initial period of three years. Jubilant Life Sciences recently commissioned its manufacturing facility at the special economic zone in Gujarat with the commencement of commercial production of 10,000 TPA niacinamide and an intermediate, 3-cyanopyridine, in order to cater to the growing global needs of nutrition ingredients. GVK forms drug discovery alliances GVK Biosciences entered into a partnership with the Prevention of Organ Failure (PROOF) Center of Excellence, focusing on biomarker development for heart, lung and kidney failure. The PROOF center, a not-for-profit center of excellence for commercialization and research that is funded by the Government of Canada, has licensed the popular GVK BIO Online Clinical Biomarker Database (GOBIOM) to help evaluate the commercialization potential of the PROOF center's biomarkers for heart, lung and kidney disease. The GOBIOM database is a comprehensive collection of all the clinically evaluated, exploratory and preclinical biomarkers associated with different therapeutic areas reported in global clinical trials, clinical and preclinical studies. GVK Biosciences has also entered into a drug discovery alliance with the Moulder Center for Drug Discovery Research at Temple University. As part of the multi-year integrated drug discovery collaboration, GVK BIO will be responsible for the target validation, lead identification and lead optimization of small molecules in selected therapeutic areas, including cardiovascular, metabolic, and central nervous system disorders. PPD named best CRO by Scrip Pharmaceutical Product Development (PPD) has been named the best contract research organization by Scrip Intelligence. It also honored PPD for deploying the best technological development in clinical trials for the innovative technology solution, created in collaboration with the Microsoft Corporation. This improves the efficiency of managing risk evaluation and mitigation strategy (REMS) programs mandated by the US Food and Drug Administration. Scrip presented both the awards to PPD at the seventh annual Scrip Awards ceremony on November 3 in London. PPD was recognized for its expertise and innovation in helping clients develop life-changing medical treatments. Launched in 1985 as a one-person consulting firm, PPD today is one of the world's leading contract research organizations. The PPD REMS solution is a first-of-its-kind technology platform that integrates, manages and tracks all REMS resources along with data and information. It is based on the Microsoft Amalga Unified Intelligence System and Microsoft HealthVault. The Scrip Awards acknowledge achievements across a broad range of areas in the pharmaceutical industry. While the Microsoft Amalga Unified Intelligence System is a data aggregation platform that gives healthcare professionals access to information they need when they need it, the Microsoft HealthVault is a personal health application platform that lets consumers gather, store and share health information online. Quintiles acquires Advion BioServices Quintiles closed the previously announced agreement to acquire Advion BioServices, a premier US-based bioanalytical laboratory. Now known as Advion Bioanalytical Labs the group will offer good laboratory practice pharmacokinetic/pharmacodynamic testing and other services to biopharma companies worldwide. Quintiles' ability to provide customers with actionable early-stage data to make development decisions faster has taken a significant step forward with the closing of this agreement. While Advion BioServices has more than 180 employees at facilities in Ithaca, Manassas, and Indianapolis in the US, Quintiles' network has more than 20,000 engaged professionals in 60 countries. Quintiles Global Laboratories supports global and regional trials in almost every country in the world with wholly owned facilities in the US, Europe, South Africa, India, China, Singapore and Japan, and a tightly coordinated network of affiliate laboratories in Argentina and Brazil. Covance CLS ranks first in survey Covance's central laboratory services (CLS) was ranked first in an independent global survey of 550 physician investigators participating in clinical trials. The majority (54 percent) of the study participants named Covance central laboratory services as their â€œmost preferredâ€? central laboratory, with investigators citing Covance three times more often than the nearest competitor. Investigators also reported having the â€œbest overall relationshipâ€? with Covance, rating it 8.4 on a scale of 1 to 10. Survey results showed that factors that lead to a strong relationship between investigators and a central laboratory include effective communication, the laboratory's reputation for reliability and quality, and easy-to-use collection kits. Respondents ranked Covance first in all of the key performance metrics, from customer service to timely and accurate reporting. Parexel partners with UCB Parexel International Corporation has been selected as one of two strategic partners by UCB, a global biopharmaceutical company, to provide clinical development services worldwide. Parexel will work with UCB, to drive innovation and accelerate development, as well as to increase productivity and cost effectiveness. The agreement is effective for all of UCB's new clinical study programs on a global basis. With the help of the strategic partnership, UCB will receive the benefits of Parexel's proven clinical processes through all phases of development, which are supported by its market-leading eClinical technology platform. UCB will also leverage Parexel's consulting expertise in regulatory affairs and commercialization. Mr Iris Loew-Friedrich, executive vice president and chief medical officer of UCB said that Parexel would be instrumental in helping UCB expand their global drug development activities in Asia. TCG and JSW collaborate TCG Lifesciences (TCGLS) entered into a strategic agreement with JSW Lifesciences, an EU-based full services contract research organzation, to strengthen its R&D offerings in the area of central nervous system. This agreement will enable TCGLS and JSW to offer specialized preclinical and early clinical development services in the neuroscience domain to their combined customer base. Mr Swapan Bhattacharya, managing director, TCGLS, said that this deal will add a new dimension to TCGLS' present offerings in the integrated drug discovery domain. Speaking about the importance of capitalizing on the 'India benefit' factor, Dr Manfred Windisch, chief executive officer, JSW Lifesciences, said that this opportunity would allow both companies to grow. MITCON enters CDM training MITCON, a leading consultancy group from Pune, forayed into training in the clinical data management industry through its pharma and biotechnology divison. MITCON's managing director, Dr Pradeep Bavadekar said that MITCON is committed to provide quality industrial job oriented training at an affordable cost. MITCON has so far conducted 15 batches of clinical research training and more than 70 students have got career opportunities due to this training. Considering the huge demand in the upcoming CDM area, MITCON has identified Pune-based Phoenix Progressive Certifications Enterprise, as their associate partner for providing clinical data management training. ]]> <![CDATA[Gates Foundation to invest $35 mn]]> https://biospectrumindia.com/news/95/6812/gates-foundation-to-invest-35-mn.html https://biospectrumindia.com/news/95/6812/gates-foundation-to-invest-35-mn.html Fri, 09 Dec 2011 15:32:00 +0530 The Bill & Melinda Gates Foundation will invest $35 million in grants to expand the pipeline of groundbreaking ideas that can help women and children live more prosperous and healthy lives. The foundation has announced new family health initiatives that include preventing preterm birth, managed in partnership with the Global Alliance for the Prevention of Prematurity and Stillbirth (GAPPS), which is an initiative of Seattle Children's. The foundation will invest $20 million in the discovery and development of interventions to prevent preterm birth and stillbirth by limiting infection and improving nutrition. Also, it will invest $15 million in research to discover the causes of growth faltering during the first 1,000 days of life and to identify effective and affordable interventions to promote healthy growth. In addition, the Gates Foundation announced $9 million in funding for a new related initiative, Biomarkers of Gut Function and Health. Scientists decode pigeonpea genome Considered to be an orphan crop due to lack of research attention until few years ago, a group of 31 Indian scientists from Indian Council of Agricultural Research (ICAR) institutes, state agricultural universities and Banaras Hindu University, led by Professor Nagendra Kumar Singh from ICAR's National Research Center on plant biotechnology at New Delhi, decoded the genome of pigeonpea, the second most important pulse crop of India. Availability of the pigeonpea, arhar, genome sequence will accelerate development of new varieties and hybrids with enhanced productivity. The genome of the popular arhar variety 'asha' was assembled using long sequence reads of 454-FLX second generation sequencing technology resulting in 511 million base pairs of high quality genome sequence information. The scientists have identified 47,004 protein coding genes in the arhar genome, of which 1,213 genes are for disease resistance and 152 genes for tolerance to drought, heat and salinity that make it a hardy crop. Regional center of IIPR in Karnataka The Indian Institute of Pulses Research (IIPR), Kanpur, UP, has signed a memorandum of understanding (MoU) with the University of Agricultural Sciences (UAS), Dharwad, Karnataka, for the establishment of a regional research center and off season nursery at Dharwad, in Karnataka. At present, the center will function from the sericulture building of the university. It will cater to the research and extension needs of pulse crops like blackgram, greengram, chickpea and pigeonpea grown in south Indian states including Karnataka. The center will also act as an off-season nursery during the summer for advancing breeding material of chickpea, lentil and peas. In addition, the center will develop location specific technologies for pulses and would contribute to capacity building of line department officials and impart need-based training to pulse growing farmers in association with the UAS, Dharwad. Dr N Nadarajan, director, IIPR, on behalf of secretary, DARE and director general, ICAR and Dr H S Vijay Kumar, registrar, UAS, Dharwad signed the MoU in presence of Vice Chancellor Dr R R Hanchinal. TB detecting E-nose to get funding A new hand-held device called the Electronic Nose, which has the potential to diagnose TB in symptomatic patients, was awarded a $950,000 grant from Grand Challenges Canada and the Bill & Melinda Gates Foundation on Novemeber, 07, 2011. The funding will help determine whether the E-nose is able to detect TB immediately and non-invasively from the patient's breath. The development of the E-Nose is a collaboration between the International Center for Genetic Engineering and Biotechnology, New Delhi, India, and Next Dimension Technologies, California. C-CAMP initiative in Bangalore Center for Cellular and Molecular Platforms (C-CAMP), a Department of Biotechnology, Government of India, initiative and a part of the Bangalore Bio Cluster, which has completed one year on November 14, 2011, will be setting up a faculty of innovation and entrepreneurship in next one year. Announcing this at the C-CAMP technology conclave in Bangalore, Professor S Ramaswamy, CEO, and co founder of C-CAMP said, â€œWe are looking at incubating at least two enterprises in the next 12 months. We have ear marked about 50 lakh for this new initiative.â€? C-CAMP, which recently became the first international Association of Biomolecular Research Facilities chapter in India and the Southeast Asian region, is providing technology training programs to generate a pool of experts. ]]> <![CDATA[Agilent launches dissolution apparatus]]> https://biospectrumindia.com/news/95/2896/agilent-launches-dissolution-apparatus.html https://biospectrumindia.com/news/95/2896/agilent-launches-dissolution-apparatus.html Fri, 09 Dec 2011 15:31:00 +0530 Agilent Technologies introduced the 709-DS dissolution apparatus, which features a bath-free design that provides an unobstructed view of the dissolution vessel. This new tool is used to test the release profile of many dosage forms. In addition to improved visibility of the dissolution environment, the 709-DS offers increased efficiency through rapid media heating and elimination of water bath cleaning. Vessel media is heated through Agilent's direct vessel heating system. The instrument is based on the proven 708-DS platform for consistent performance and offers support for a wide range of workflows. Automated sample collection and online ultraviolet dissolution integration are available as options to increase laboratory productivity and efficiency as well. SAFC introduces CHOZN GS cell line Sigma-Aldrich Corporation's custom manufacturing and services business unit, SAFC, introduced a novel CHOZN GS zinc finger nuclease (ZFN)-modified chinese hamster ovary (CHO) cell line. The new CHOZN GS cell line is the first commercially available glutamine synthetase (GS) knockout CHO cell line, that has been proven to shorten the bioproduction times in early development, enabling customers to enhance their speed-to-market and increase cost efficiency. CHOZN GS was developed using SAFC's proprietary CompoZr ZFN technology, that inactivates the glutamine synthetase gene rendering the cells dependent on L-glutamine. Development timelines for biopharmaceuticals can be shortened, as the cells do not require L-methionine-D, L-sulfoximine (MSX) selection for development of production clone. Knocking out the GS gene that produces this enzyme means the addition of this MSX inhibitor is no longer required for r-protein clone selection, providing enhanced supply chain security, decreasing development time for identification of producing clones, and enabling customers to file investigational new drug applications sooner. The parental cell line is cGMP banked using animal component free, chemically defined media and has extensive viral testing, along with a traceable history. Acrodisc MS Syringe Filter launched Pall Corporation, a filtration, separation and purification leader introduced the Pall Acrodisc MS Syringe Filter, the first syringe filter certified for low extractables in high performance liquid chromatography/mass spectrometry (LCMS) applications. Designed specifically for LCMS, the Acrodisc MS syringe filter improves the accuracy of testing, enhances LCMS performance, and extends the longevity of testing instrumentation. The low extractable levels of the new Acrodisc MS syringe filter minimize interference with the ionization process and reduce the need for retesting. This lowers costs while minimizing downtime due to unexpected contamination. To ensure high performance, product tubes are packaged individually so that filters that are currently not in use remain sealed and protected from external contamination. GeneArt Algae Kits launched Life Technologies Corporation introduced its GeneArt Algae Engineering Kits, the first commercially available genetic modification and expression systems for photosynthetic microalgae Chlamydomonas reinhardtii and Synechococcus elongatus. The strains are model organisms for the study of photosynthesis, circadian rhythms and nutrient-regulated gene activity, and are being investigated for bioproduction of biofuels, nutraceuticals and specialty chemicals.The algal strains contained in the kits are the first that can be shipped and stored frozen at - 80 degrees Celsius, which simplifies their standardization and use. Enhancements for MiSeq introduced Illumina, a leading developer, manufacturer, and marketer of life science tools announced three innovative workflow solutions to support its MiSeq personal sequencer system. The three additions to the MiSeq ecosystem, include TruSeq custom amplicon kits, New Nextera DNA sample preparation kits and BaseSpace. Nextera and MiSeq users can go from DNA to analyzed data in less than eight hours. For custom amplicon sequencing, TruSeq Custom Amplicon Kits provide a highly multiplexed and cost-effective workflow, allowing studies that are not feasible using capillary electrophoresis sequencing methods to be completed in as little as two days with no additional hardware required. Researchers can design a custom assay to target up to 384 genomic regions in a single experiment using Illumina's DesignStudio, an intuitive, online tool. ]]> <![CDATA[Glenmark enters cosmetics segment]]> https://biospectrumindia.com/news/95/6582/glenmark-enters-cosmetics-segment.html https://biospectrumindia.com/news/95/6582/glenmark-enters-cosmetics-segment.html Fri, 09 Dec 2011 15:29:00 +0530 Glenmark has entered the high-end cosmeceutical segment in India with the launch of the Immanence-IDC's scientific and sophisticated anti-ageing product line in India. Glenmark has formed a new division, Glenmark CosmoCare, to pursue opportunities in the burgeoning Indian cosmetics segment. The IDC line is based on the highly advanced 'Regen 16', a patent-pending technology that simultaneously targets the 16 main mechanisms responsible for skin ageing and offers some of the highest concentrations of cosmetic active ingredients, which in some products is up to 43 percent. The line of products will be available at clinics of leading cosmetologists and dermatologists in 30 cities across India. Glenmark recently entered into a 10-year agreement with Immanence-IDC to distribute the Canadian company's high-end dermatology products in eight countries, including India, Brazil, Mexico, South Africa, Egypt, Vietnam, Malaysia and Thailand. Glenmark plans to roll out the range in most of these markets by end of financial year 2012. Avesthagen forms JV with SAVA Medica Avesthagen, a fully integrated life sciences and genomic healthcare company, and SAVA Medica, Pune, which is an emerging global pharmaceutical company, have formed a 50:50 joint venture (JV) in Avesthagen's subsidiary, Dhanvantari Botanicals. The JV would market and sell a line of Avesthagen's bioactive products in several countries, including the US, Brazil, Russia, India and South Africa. Dhanvantari Botanical's products include 11 over-the-counter brands, such as AmlaPure, Ashwagandha, BosWell, Gymnema, ThinkWell, Tribulus, Triphala, TriplaLax, WinterWell, XanoMax and GojiMax. It also includes highly qualified bulk ingredients for the wellness and nutraceutical markets. According to the agreement, Avesthagen would grant and SAVA Medica Limited will earn exclusive marketing rights for Avesthagen's seven lead, first generation scientifically validated and clinically active research products. This JV sets the footprint of SAVA Medica in the $102 billion global nutraceuticals market. Sun Pharma reports growth of 18% Sun Pharmaceutical Industries reported unaudited numbers for the second quarter (Q2) of the fiscal year (FY) 2012 stating that the net sales from operations stood at 1,895 crore, registering a growth of 42 percent over the same quarter last year. The India branded generic sales at 705 crore, excluding third party manufacturing business, grew by 18 percent over Q2 last year. On the other hand, the US-finished dosage sale at $175 million, international formulation sales at $56 million and the EBITDA margin stood at 41 percent. Net profit was 598 crore, equivalent to 32 percent of the net margin. Pentavalent vaccine in 2012 Indian Immunologicals hopes to release its pentavalent vaccine in 2012. The vaccine would consist of DTP, HiB, HepB vaccines and would be in accordance with the recommendations of the WHO, which recommends to introduce the pentavalent vaccine in a phased manner in order to replace the trivalent vaccine as part of the universal immunization program. Indian Immunologicals is also involved in the development of an oral human papilloma virus (HPV) vaccine for cervical cancer. Mr Anand Kumar, deputy managing director, Indian Immunologicals, said the product is one-of-its-kind and is currently under clinical trials. Other products in the pipeline include a chikungunya vaccine and a recombinant tick vaccine. Erythropoeitin tech to sell for $5 mn Transgene Biotek announced the sale of technology for recombinant human Erythropoietin (rh-EPO) to TSS EXPORT GmbH FZE, which is one of the group companies of the TSS Group, for $5 million. The transfer and sale of this technology is expected to be completed over a period of approximately five to six months. The company is also in the process of expanding its own in-house infrastructure to augment production capacities for DHA, an omega three fatty acid and tacrolimus. Both active pharmaceutical ingredients (APIs) are being aimed at the non-regulated markets. The company's management is also in talks with a number of manufacturers in Europe and North America for strategic partnerships. BIRAC gets cabinet approval The Government of India gave its approval for setting up the Biotechnology Industry Research Assistance Council (BIRAC), as 'not-for-profit' section 25 company, on November 24, 2011. BIRAC, which has a vision to make India globally competitive in biotech innovation and entrepreneurship, is expected to stimulate, foster and enhance the strategic research and innovation capabilities of the biotech industry in India, particularly SMEs. The company will operate with a core budget for its regular activities and recurring expenses for human resources and operational cost with an initial outlay of 70 crore for two years. Besides providing support services such as IP facilitation, legal and contracts, regulatory and clinical trial facilitation, mentoring and capacity building, BIRAC will also provide early and late stage funding, including Small Business Innovation Research Initiative, Biotechnology Industry Partnership Programme and ignition grant. The company will also take care of the technology transfer and acquisition in national priority areas. Besides that it will be also involved in technology development in the form of incubators and parks across the country. Use of bio-fertilizers on the rise A study of available data indicates that the use of bio fertilizers is increasing in India. The study reveals that the total area coverage under bio-fertilizer use is less than three percent of the total cultivable area in the country. Mr Harish Rawat, minister of state for agriculture and food processing industries, in a written reply to a question in the Rajya Sabha in November, replied that the total production of bio-fertilizers was 25,065 metric ton (MT), 20,040 MT and 37,998 MT during 2008-09, 2009-10 and 2010-11 respectively. The use of organic manures and bio-fertilizers is being promoted through various schemes, such as the National Project on Organic Farming, the National Horticulture Mission, Horticulture Mission for North-East and Himalayan States and the Rashtriya Krishi Vikas Yojana. Vaccine industry, academia deliberate The Department of Biotechnology (DBT), Government of India, organized a symposium titled 'Vaccines â€“ from Discovery to Translation' in New Delhi. The objective of the event was to bring industries and academia together in the field of vaccine R&D, and provide a scientific basis for future vaccine design and development. The event saw participation from 100 leading experts from different fields of vaccinology in both its human and veterinary domains. The symposium facilitated valuable cross-fertilization of ideas and approaches among researchers, often narrowly focussing on their specific diseases or methods. The major points on which most of the speakers and panelists agreed included the furthering of the mandate successfully, significant focus on moving forward with novel ideas that will improve understanding of how vaccines can be designed, developed and delivered, particularly against diseases where past research has not been successful. Health sector to get 2.5% of GDP The healthcare sector in India will get a boost as the Planning Commission has increased budget for the sector by 0.7 percent, from 1.8 percent to 2.5 percent of the country's gross domestic product (GDP). Ms Syeda Hamid, member of Planning Commission, said that this will be a very big jump. She said that to strengthen the National Immunization Programme there is a need to bring confidence in the community and people to avail this help. She added that year-on-year achievement has to be recorded in order to get maximum benefits. The planning commission will insist on the fact that what is spent, has to be commensurate in result. For the outreach programme, she suggested that interaction of local police, anganwadi workers and religious heads of different sects would have to help in mobilizing the people. BMS & FICCI organize conference Bristol-Myers Squibb, India, in association with the Federation of Indian Chambers of Commerce and Industry (FICCI), organized a roundtable conference on 'Developing Capacities to Tackle Chronic Diseases' in Delhi on November 14, 2011, on the occasion of World Diabetes Day. The conference was supported by India Health Progress (IHP), an initiative aligned at ensuring access of healthcare to all. The event was aimed at creating awareness about the prevalence of acute and chronic diseases, and the dire and immediate need to spread prevention awareness about these diseases. In addition, the discussions clearly brought out the important role that will have to be essayed by insurance providers in terms of making drugs more affordable and accessible to patients. Consultations on stem cell guidelines The Indian Council of Medical Research (ICMR) will hold public consultations on ICMR-Department of Biotechnology (DBT) Guidelines for Stem Cell Research and Therapy (2007) on December 17, 2011 at New Delhi. The consultation is aimed to generate consensus among all stake holders of the northern region, including New Delhi, Haryana, Uttar Pradesh, Uttaranchal, Punjab, Himachal Pradesh, Bihar, Jharkhand and Jammu and Kashmir. Indians need better MS treatment Multiple Sclerosis International Federation (MISF) has called for urgent action and better treatments to be made available for Multiple Sclerosis (MS) patients in India. A summit conducted by the MSIF in New Delhi saw participation from leading MS specialists from the US, UK and India. The summit addressed a gathering of approximately 400 persons that included delegates from 48 countries, special invitees from the government, donors, supporters from corporate houses and the city's select individuals. Experts revealed that although there was no cure for MS, there is a great deal of ongoing research in the field and there continues to be a focus on the immune system in investigational therapies. There are many drugs that can slow down the progression of the disease. Disease modifying drugs (DMDs) are drugs that affect the long-term progression of MS. In addition, scientists are trying to develop techniques that allow brain cells to generate new myelin (nerve layer) or that prevent the death of nerves. Food associations seek ban on GM foods With the Biotechnology Regulatory Authority of India (BRAI) Bill likely to be tabled in the winter session of Parliament, two of the leading Indian food associations have declared themselves as GM-free. The Kerala Roller Flour Millers Association and the Kerala Bakers Association in separate letters has asked the Genetic Engineering Appraisal Committee (GEAC), Food Safety and Standards Authority of India (FSSAI), Ministry of Food Processing Industries (MOFPI) and the Confederation of Indian Industry (CII) to put an immediate ban on open air releases of GM food crops and deemed it essential that the policymakers safeguard the interest of the food processing sector in India. Greenpeace has supported the initiative. According to the statement issued by Greenpeace, the denial of GM ingredients by such major players of the Indian food industry, like Kerala Roller Flour Millers Association, which has a turnover of 2,000 crore, and Kerala Bakers Association that has an approximate turnover of 4,000 crore annually, underscores the seriousness of the issue GM foods has in India due to associated risks of contamination, consumer rejection and resultant monetary losses. Greenpeace demanded that the government should take into consideration the massive opposition that GM crops are facing in the country from all stake holders and redraft the BRAI Bill. Lupin acquires I'rom Pharmaceuticals Lupin's Japanese subsidiary, Kyowa Pharmaceutical Industry, has entered into an agreement with I'rom Holdings, an integrated Japanese healthcare provider, to acquire up to 100 percent of the outstanding shares of its subsidiary, I'rom Pharmaceutical (IP). Established in 1947, IP is a specialty injectables company, headquartered in Tokyo. For the fiscal year ending March 2011, IP recorded sales revenues of 358.8 crore ($69 million). IP has a significant presence in the diagnosis, procedure and combination-based (DPC) hospitals within Japan. Molecular Connections grows swiftly Molecular Connections, a pioneering in silico discovery services company, has been ranked 24th on the Deloitte Technology Fast 50 India 2011, which is a ranking of the 50 fastest growing technology companies in India. The rankings are based on percentage revenue growth over three years. Molecular Connections grew by 131 percent during this period. Mr Jignesh Bhate, CEO, Molecular Connections, credits the sharp customer focus and employees' best-in-class talent with the company's astounding revenue growth over the past three years. He says that the strong employee-customer interaction, which is a part of Molecular Connections' corporate culture, always makes customers happy with the quality and value of the services they get and in return motivates employees to offer best of their efforts to enhance customer relationship. Stem cell research facility at CCMB The Centre for Cellular & Molecular Biology (CCMB), part of the Council of Scientific & Industrial Research (CSIR), has opened a new facility, Clinical Research Facility for Stem Cell Technologies and Regenerative Medicine, at its campus in Hyderabad where in clinicians and scientists will come together to provide cell-based therapies for patients. The new facility came up with the funding to the tune of 24 crore from the Department of Science and Technology and CSIR, and is one of a kind in the country. The CCMB has tied up with the Nizam's Institute of Medical Sciences, Hyderabad, to work together to provide cell-based therapies to patients. Critical patients who have serious problems relating to liver, heart and spinal cord will be immensely benefited with this facility. Insulin delivery device launched Biocon has launched its re-usable insulin delivery device, INSUPen, in India. A world-class, differentiated device based on proprietary German technology, INSUPen is a first-in-class reusable delivery device. It is designed for efficiency, accuracy and safety and can deliver both Basalog and Insugen, thus maximizing patient convenience. INSUPen was launched by Biocon chairman and MD, Dr Kiran Mazumdar-Shaw, at a gala event. INSUPen is a breakthrough in diabetes delivery device. It is the first German technology pen offering the best user-friendly features. Advinus completes study on GKM-001 Advinus Therapeutics has successfully completed a 14-day proof-of-concept study in 60 Type II diabetic patients on its lead molecule, GKM-001, a glucokinase activator. The results of the trial show effective glucose lowering across all doses tested without any incidence of hypoglycemia or any other clinically relevant adverse events. The clinical trials on GKM-001 validate the company's pre-clinical hypothesis that a liver selective Glucokinase activator would not cause hypoglycemia (very low blood sugar), while showing robust efficacy. GKM-001 belongs to a novel class of molecules for treatment of type II diabetes. It is an activator of Glucokinase (GK), a glucose-sensing enzyme, found mainly in the liver and pancreas. Being liver selective, GKM-001 mostly activates GK in the liver and not in pancreas, which is its key differentiation from most competitor molecules that activate GK in pancreas as well. The resulting increase in insulin secretion creates a potential for hypoglycemia, a risk GKM-001 is designed to avoid. Advinus has the composition of matter patent on GKM-001 for all major markets globally. Both the single ascending dose data, in healthy and type II diabetics, and the Multiple Ascending Dose Study in Type II diabetics has shown that the molecule shows effective glucose lowering in a dose dependent manner and has excellent safety and tolerability profile over a 40-fold dose range. GKM-001 has the potential to be â€œfirst-in-classâ€? drug to address this large, growing and yet poorly addressed market. AvestaScan Genome Scan launched Manipal Health Enterprises (MHE) signed an agreement with Avesthagen for the launch of AvestaScan Whole Genome Scan (WGS) service. A whole genome scan of an individual or patient would provide information to understand his or her own genetic make-up that would lead to an increased awareness about the predisposition to a particular disease(s). The 28 diseases, which are covered by AvestaScan include major types of cancer, cardiovascular diseases, diabetes, schizophrenia, Alzheimer's, asthma, anemia and arthritis. The whole genome scan will be carried out on DNA extracted from saliva or buccal swab provided by the individual. The results of the analyses will be available to the individual through an on-line secure web portal. USFDA approval for Strides' injection Onco Therapies, a wholly owned subsidiary of Strides Arcolab, received US FDA approval for Carboplatin Injection 10 mg/ mL packaged in 50 mg/ 5 mL, 150 mg/ 15 mL, 450 mg/ 45 mL and 600 mg/60 mL multi-dose vials. The product will be manufactured at Strides' oncology complex in Bangalore, which received approval from the European regulatory authorities in June, 2010. The US market for generic Carboplatin is approximately $35 mn whereas the combined European market for Carboplatin stood at $138 mn. Carboplatin is part of the oncology portfolio licensed to Pfizer in January 2010 for the US market and will be launched shortly. Sisco Research acquires Madras Biotech Sisco Research Laboratories (SRL) completed the acquisition of Chennai-based biotech company, Madras Biotech. The value of the deal remains undisclosed. Madras Biotech engages in the manufacture of a range of products suitable for advanced molecular biology and biotechnology techniques, typically DNA and protein markers and PCR products. Due to the growing potential in the biotechnology industry, SRL introduced its own BioLit range of products to the research markets in India and overseas. SRL will begin the next phase of streamlining and merging of operations of this division into the SRL framework and will invest in further expansion and R&D. Mr Akash Agarwal, director, SRL, says, â€œThis acquisition is all the more important for us since it marks the first ever acquisition deal by SRL in its 37-year-old history.â€? Eppendorf center gets ISO 17025:2005 accreditation Eppendorf India's Pipette Calibration Centre in Chennai has received ISO 17025:2005 accreditation from National Accreditation Board for Testing and Calibration Laboratories (NABL). The Centre can now calibrate any make of piston stroke pipette and issue certificate as per the guidelines of the NABL. This is the first-of-its-kind accreditation in the industry for piston stroke pipette. The NABL provides laboratory accreditation services to laboratories that are performing tests/calibrations in accordance with ISO/IEC 17025:2005 and ISO 15189:2007 for medical laboratories. These services are offered in a non-discriminatory manner and are accessible to all testing and calibration laboratories in India and abroad, regardless of their ownership, legal status, size and degree of independence. ]]> <![CDATA[Make India 'hassle-free' for innovation]]> https://biospectrumindia.com/news/95/1172/make-india-hassle-free-for-innovation.html https://biospectrumindia.com/news/95/1172/make-india-hassle-free-for-innovation.html Fri, 09 Dec 2011 15:26:00 +0530 IKMC 2011: Global Innovation Exchange discusses the steps to be taken in order to make India a global hub for innovation, not just in life sciences but also in other knowledge sectors L-R: Dr M K Bhan, secretary, Dept of Biotechnology, Mr N Kiran Kumar Reddy, chief minister of Andhra Pradesh & Dr J Geeta Reddy, state industry minister Many sectors of the Indian economy have embarked on innovation. But has this innovation bug bit every one? When will innovation become a way of life? And what are the things that are needed to be done in order to make the country a global hub for innovation, not just in life sciences but also in all the knowledge sectors. These were some of the topics of discussion during the two-day IKMC 2011: Global Innovation Exchange, organized by the IKP Knowledge Park in Hyderabad in mid-November. The fourth edition of this annual exercise, by one of the country's leading bioparks, expanded the focus beyond its core life sciences sector to energy and mobile applications and health? Dr M K Bhan, secretary, Department of Biotechnology (DBT), set the tone in his key note address by discussing the various nuances of the nation's tryst with innovation in recent times. The eminent technocrat admitted that the nation had wasted precious time until the late 1980s by ignoring the need for innovation in a closed economy. â€œWe got the freedom from the colonial government in 1947. However, have we used it fully to make the environment hassle-free for innovators in various fields,â€? he asked rhetorically. "Indians have a strong work ethic and the spirit of entrepreneurship. These are all coming to the fore in the economic freedom enjoyed by the people in the last two decades. We are restarting our journey on innovation. We can see far reaching changes in our economic landscape for the better in the next few decades" Mr Narayanan Vaghul chairman, IKP The DBT secretary said most of the national systems, including the government, were not prepared for large scale innovation till recently. Innovation, to a large extent, is driven by demand. Similarly, creation of hassle-free environment is also a factor driven by demand from innovators. So there is a need for citizens to demand more from the system. â€œThe more you demand, the more you will get,â€? said Dr Bhan. Given the nation's current state of socio-economic development, there is a need to focus on forward looking and socially-relevant innovation in many fields, Dr Bhan said. â€œEven as we embark on this innovation journey, we need to be aware that innovative products and services happen through trial and error. As a society, we also need to accept that failure is also a part of the innovation process,â€? he said referring to the society's premium placed only on success stories. Dr Bhan highlighted the success story of India's vaccine industry which today supplies some of the most essential vaccines to the entire world. At the same time, he lamented that children of India get less essential vaccines than their counterparts in many African countries and even small neighbors like Bangladesh or Sri Lanka. The reason for this being the tender-based lowest pricing mechanism of the government that does not incentivize Indian vaccine makers to supply to the local markets. "Even as we embark on this innovation journey, we need to be aware that innovative products and services happen through trial and error. As a society, we also need to accept that failure is also a part of the innovation process" Dr M K Bhan secretary, Department of Biotechnology, Government of India There are opportunities galore for India's innovators. Imagination and excellence in execution are key ingredients for success. Also, there are immense opportunities to create innovative financial mechanisms to support new inventions that will happen in the near future, Dr Bhan said. Funding innovation For innovators, this is one of the best times. There are many institution in the investment game. One such agency is the Bill and Melinda Gates Foundation, which has identified India as one of the focus areas for its global grand challenges program. In fact, the foundation has tied up with IKP to increase the program's reach in the country. Dr Peter Small, program director for the Gates Foundation in India, said the foundation will give a grant of $100,000 for the best ideas. â€œOne bold idea is all it takes,â€? Dr Small said. The foundation's focus is on development of cost effective healthcare solutions. In fact, the foundation will fund up to 5 crore ($1 million) in order to take the selected ideas to the next stage. Since 2008, under the program, 603 researchers in 44 countries are pursuing their brilliant ideas with the support of the foundation. One of the Indian companies that has received the grant is Pondicherry Biotech, which is developing an effective intra-uterine device. Another project that has got support is an electronic nose to detect tuberculosis developed by a research team at the International Center for Genetic Engineering and Biology (ICGEB), New Delhi. Ms Deepanwita Chattopadhyay, CEO, IKP, said that their efforts were focused on identifying the pockets of knowledge that exists in the country. How do we identify them? She said that under the GCE program, 20 winning ideas will be shortlisted in the country and at least three of these will get the initial grant. She said that IKP will work as an incubator and mentor the winners for two years and also rope in the extended network of mentors in the country to help turn these ideas into successful products. During a panel discussion in innovation, Mr Shekar Kirani, of Angel Partners, a venture capital firm, said that there is a surge in innovative ideas in the country. Accel received over 1,000 high quality applications last year. The company met nearly 250 of the applicants and had serious discussions with about 50. â€œWe may probably fund about 10 of these applications,â€? Mr Kirani said while explaining the inner workings of a venture capital fund. â€œAnd we usually look at a 10-year investment window for each of these projects.â€? Dr Bhan said the government has announced a new Ignition Grant to reward innovative ideas. Grants will be given to individuals with excellent ideas. So far, most of the government schemes were restricted to institutions or companies and rarely supported individuals with good ideas. He also highlighted the two new schemes, SIBRI and BIPP, which have been providing soft loans and grants to biotech companies for the last three years. India's innovation need Stressing the need for innovation, IKP's chairman and former banker, Mr Narayanan Vaghul pointed out the unique position of India in the global affairs. He referred to eminent historian Niall Ferguson's observation that the 21st century will be defined by the conflict between the ancient civilization of China and the western Christian civilization based on strong protestant work ethic and innovation. â€œThere is a dimension to this, missed by the eminent historian,â€? Mr Vaghul said. He opined that a rising India will also be a key factor in the 21st century. â€œIndians have a strong work ethic and the spirit of entrepreneurship. These are all coming to the fore in the economic freedom enjoyed by the people in the last two decades,â€? he added. â€œWe are restarting our journey on innovation. We can see far-reaching changes in our economic landscape for the better in the next few decades,â€? he said. IKP's mentor and chairman of ReaMetrix, Dr Bala Manian, anchored various key sessions on fostering innovation. Chief Minister of Andhra Pradesh Mr N Kiran Kumar Reddy and Industry Minister Dr J Geeta Reddy also attended the conference. There were nearly 60 posters displayed by small companies and research groups at the conference, which were scanned thoroughly by the participants on both the days. It was an innovative step to spread the message of innovative research work by those who could not be present in person to interact with the participants. -Narayanan Suresh in Hyderabad ]]> <![CDATA[Downturn squeezes health programs]]> https://biospectrumindia.com/news/95/1834/downturn-squeezes-health-programs.html https://biospectrumindia.com/news/95/1834/downturn-squeezes-health-programs.html Fri, 09 Dec 2011 15:22:00 +0530 Nandita Singh The author is Editor of BioSpectrum nanditas@cybermedia.co.in Downturn is taking its toll on India's health programs. UN AIDS has put a freeze on the Global Fund spend until 2014. The decision came about recently, while reviewing the applications for its latest round of funding that would have released money for 2011-13. About 150 countries will feel the pinch, India included. The impacted diseases are Tuberculosis, Malaria and AIDS. This Global Fund, since its creation in 2002, has spent over $20 billion for improving health outcomes in these countries. Of this, almost $2 billion came to India as free money, as India was classified as low-income developing country. Now, India will have to summon its own resources to bridge the funding gap. A step in the direction has already been taken with the health spend increase as a percentage of GDP. On the recommendation of a High Level Expert Group (HLEG), the Planning Commission has increased the budget-share for the health sector to 2.5 percent of GDP from the earlier 1.8 percent. The HLEG has proposed that every Indian citizen should be entitled to a National Health Package of free services. The specific services are yet to be outlined. But since India's health spend was one of the lowest globally, this one step cannot fill in for the billions of dollars of foreign funding that will no longer be available for research and development. And, if the GDP gets a hit the net effect on health spend will be negligible. The country needs to revise plans and devise means to ensure that its disease specific programs do not suffer. Meanwhile, in 2011, December 1, which is celebrated as the World AIDS Day, marks a major milestone in the fight against AIDS. India, which has the highest population of the HIV-infected people in Asia, recorded a 56 percent decline in new HIV infections from the peak of 1997. This is a significant achievement for the fight that has been going on for the last 30 years. What has helped India achieve this 56 percent decline in new HIV infections is its National AIDS Control Program that has been working closely, since 1991, with World Bank and a number of other partners to prevent vulnerable population that is at the highest risk of contracting HIV. The focused, targeted approach has worked in a cost effective manner. The AIDS pandemic has been slowed considerably. Prevention strategies for vulnerable population have slowed the transmission rates. Coupled with antiretroviral drugs, this has been saving lives. Resources for prevention and treatment are important in the light of the fact that first-generation AIDS vaccine is still at least 10 years away, though the scientific understanding of the path to HIV vaccine has improved considerably. A team of researchers associated with the International AIDS Vaccine Initiative (IAVI), The Scripps Research Institute, and biotechnology companies Theraclone sciences and Monogram Biosciences reported the isolation of 17 novel antibodies capable of neutralizing a broad spectrum of variants of HIV virus. This apart, the RV144 trial that involved 16000 volunteers in Thailand has given scientific community a lease of hope. Further, the structural characterization of a number of broadly neutralizing antibodies has boosted the vaccine research efforts. Appropriate resource allocation is a necessity. Given that in India, total number of cases per year for HIV (2.4 million), Malaria (2 million) and Tuberculosis (1.9 million) are all competing for resources. ]]> <![CDATA[JE vaccine: Hope on the anvil]]> https://biospectrumindia.com/news/95/2196/je-vaccine-hope-on-the-anvil.html https://biospectrumindia.com/news/95/2196/je-vaccine-hope-on-the-anvil.html Fri, 09 Dec 2011 15:11:00 +0530 Over 400 people, mostly children, in North India succumbed to acute encephalitis syndrome in 2011 alone. Repeated immunization efforts have not yielded expected results, and as Indian companies make a foray into production of the Japanese encephalitis vaccine, there is hope for improvement in the situation Each year the monsoon rains bring with them a sense of despair and helplessness among the people in Northern India because of the advent of Japanese encephalitis (JE). This incapacitating disease mainly targets children below the age of 15, with 70 percent of the cases resulting in either death or crippling long term neurological disorders. It is said to be endemic in countries such as China, Burma, Thailand and Sri Lanka and in parts of India. It has been estimated that over the past 60 years, JE has infected approximately 10 million children globally, killing three million and causing long term disability in four million children. Viral encephalitis which causes inflammation of the brain, can be broadly classified into Enteroviral encephalitis, caused by consuming contaminated water and Japanese encephalitis, propagated by mosquitoes. The debilitating disease of Japanese encephalitis is caused by the JEV virus belonging to the Flaviridae genus. Transmitted via mosquitoes, with pigs and water birds acting as amplifying hosts for the virus, Japanese encephalitis is the leading cause of viral encephalitis in Asia with 30,000-to-50,000 clinical cases reported annually. The data surrounding Japanese encephalitis in India is shocking, to say the least. Since the first case was reported in 1952, several outbreaks have been reported in the states of Uttar Pradesh, West Bengal, Assam, Andhra Pradesh, Karnataka, Bihar, Tamil Nadu, and Haryana. According to the National Vector Borne Disease Control Programme, since 2003, over 27,000 cases of JE have been reported, causing over 5,800 deaths in India alone. The fact that the disease mainly affects the poorer sections of society has been cited as the reason behind the government's apparent lack of proactive stance in combating this disease. Things changed in 2005 when an epidemic like situation arose in North India where, close to 6,000 cases were reported in Uttar Pradesh alone, causing the death of 1,300 children. This led to a mass immunization program by the Government of India which saw over nine million children being vaccinated in 2006 and the introduction of a plan for a mass vaccination program in 104 endemic districts in 11 states of India in a phased manner for five years. The progress so far Taking stock of the impending need for a JE vaccine, Central Research Institute (CRI), Kasauli, Himachal Pradesh, was the first organization to manufacture a Japanese encephalitis vaccine in India. The CRI developed an inactivated vaccine using a mouse brain source. The use of mouse brain cells as a culture system, however, posed many challenges, which included, the evident complications in maintaining consistency in all samples along with the difficulty in large-scale production. The production of the vaccine was stopped in 2007, when the Central Drugs Licensing Approving Authority suspended its production, following failure to abide by the good manufacturing practices guidelines that have been specified by the World Health Organization. Following the subsequent closure of CRI and two other public sector units producing vaccines on the same grounds, there was no JE vaccine manufacturing facility in the country. The vaccine that is currently being sourced by the government is the SA-14-4-2, which is licensed and produced by Chinese company - Chengdu Institute of Biological Products. The live attenuated Chinese vaccine is being produced since 1988 and is licensed in India and other countries such as Nepal, Sri Lanka, Thailand and South Korea. Since its introduction, over 300 million doses have been administered to children in the various endemic regions around the globe. Even though the efficacy of Chinese vaccines over other inactivated mouse brain cell-based vaccines has been proven in many studies, the method of dosage is a topic of contention. It is being given in the form of a two-dose vaccine in one or three month schedule in some countries. However, in India, it is a single-dose vaccine. Vaccination with two doses has been shown to give 100 percent sero-conversion rates or 100 percent effectivity in producing JE specific antibodies. A single dose of the vaccine was shown to have 85 to 100 percent seroconversion with 85 percent effectivity in preventing the disease, as opposed to 98 percent effectiveness that is observed in the two-dose regimen. Moreover, even after five years of use, no organized study has yet been carried out in India to test the efficacy of this vaccine. The promising future The growth of the Indian vaccine industry during the last few years has encouraged many to try and produce safe and efficacious Japanese encephalitis vaccines indigenously. Prime examples of industry-academia relations are the collaborations of National Institute of Virology (NIV) with Bharat Biotech and the National Institute of Immunology (NII) with Panacea Biotec. Speaking about the collaboration with NIV, Mr Sai Prasad, vice president, business development, Bharat Biotech says, â€œDr Milind Gore who heads the satellite center of NIV at Gorakhpur, Uttar Pradesh, isolated and characterized the Indian strains of JEV and then transferred them to Bharat Biotech to further develop them. We are very thankful to Dr A C Mishra, director, NIV, who helped us immensely in this collaboration and also helped us design the quality control assays for the vaccine.â€? The vaccine is currently in phase III trials and is expected to be launched in the next one-to-two years. Dr Sudhanshu Vrati, director, NII, who is involved in the research, elaborating on the challenges in doing research on the JEV, says, â€œOne of the major challenges in reducing the cost remains the fact that the JEV is classified as a biosafety level-3 (BSL-3) biological entity by the Center for Disease Control (CDC), and India in the absence of any similar regulatory body has adopted the same classification even though the virus is endemic in most regions of India. This leads to an increase in the production costs and eventually the price of the vaccine.â€? The NII has a collaboration with Panacea Biotec for the further development of the vaccine. However, Biological E, Hyderabad, has emerged as the leader, being the first to introduce the vaccine. Having completed phase III trials for the JEV vaccine, it has received manufacturing licenses for the same. In collaboration with Intercell, who had carried out the initial development for its use as a traveler's vaccine, Biological E further conducted the clinical development and designed the production for endemic use. Ms Mahima Datla, senior vice president, says, â€œWe expect to have a product launch of our Japanese encephalitis vaccine by January 2012 in the affected areas and all over India by the end of this year. We are looking to initially launch it in the private market and hope to be able to supply it to the government.â€? All the vaccines that are being developed by the collaboration of NIV-Bharat Biotech, NII-Panacea Biotec and Biological E are inactivated ones based on the Vero cell line, which makes these generally more efficacious and easier to produce on a large scale. In addition to India, other countries that have reported cases of Japanese encephalitis such as Nepal, Thailand, Burma, Bangladesh also provide distribution markets for the vaccine. European countries, which do not have a presence of this virus, already have traveler's vaccines available, manufactured by Sanofi. It is hypothesized that a larger number of players in this segment would definitely help in reducing the eventual price of the vaccine, thus ensuring the wider distribution of the vaccine. The inclusion of the Japanese encephalitis vaccine in the universal immunization programme, especially in the endemic areas, could further ensure that every child is immunized against the virus. A case in point is that of Sri Lanka which, in 2009, decided to include the Japanese encephalitis vaccine in its immunization program in order to ensure that every child in the country was immunized. Reports of the number of infections decreasing are indicators of the positive results of a wide scale immunization program. An integrated vaccination strategy along with improvement in the sanitation conditions, are urgently needed to help prevent the tragedy of JE that strikes every year. Manasi Vaidya in Bangalore ]]> <![CDATA[Labmate (Asia) to represent INFORS HT in India]]> https://biospectrumindia.com/news/95/6507/labmate-asia-to-represent-infors-ht-in-india.html https://biospectrumindia.com/news/95/6507/labmate-asia-to-represent-infors-ht-in-india.html Thu, 17 Nov 2011 13:09:00 +0530 INFORS HT, Switzerland, manufacturers of shakers and bioreactors, signed an exclusive agreement with Labmate (Asia), a partnership company that represents the interests of several world leaders in their respective fields in India. INFORS HT presents the most innovative bioreactor range for research, process engineering and small production. Labmate, with a team of over 75 professionals, provides services all over India with headquarters in Chennai and branches in Delhi, Mumbai, Hyderabad, Bangalore and Kolkata. With the investments in biotechnology and scientific research increasing in view of the ever-increasing promises in areas of nanotechnology, drug discovery and agriculture, the company said it was confident that they will have opportunities to accomplish and grow with its partners. Workshop on the Web of Process and Regulatory Trends Merck Millipore organized a two-day workshop on 'The Web of Process and Regulatory Trends' in Bangalore recently as part of its endeavor to support and serve the biopharmaceutical industry in India. Over 150 professionals from companies, such as Biocon, Lupin, Intas, Dr Reddy's, Hospira, Gland Pharma, Strides, Matrix, Promed Research Centre, Cipla, Serum Institute, Kemwell and Indian Immunologicals, participated in the event. Dr Jagashetty, the Drugs Controller of Karnataka, inaugurated the event. Lectures were delivered by 23 eminent professionals from the industry in India and abroad on topics related to current trends in processes and regulations related to the pharma and biotech industry. Dr Kurt Brorson from CDER/ US FDA delivered a lecture to the delegates through a live video conference. Regulators must be accountable: Kalam Former president of India Dr APJ Abdul Kalam came out strongly against development and supply of spurious drugs on the sidelines of a national consultation on spurious drugs in New Delhi on October 03, 2011. Citing the importance of having sufficient checks and balances, Dr Kalam said, â€œThe menace has to be eliminated from the root and the best organizations and persons who can play a role are public and private hospitals, nursing homes, clinics and medical practitioners, who should immediately report incidents caused due to spurious or sub-standard medicines to the public domain and ensure that preventive actions are taken before they become a major public health disaster.â€? Dr Kalam asserted that â€œthe regulators have to become accountable and transparent towards patients and make sure there is proper national database created from reports reaching the Government of India to track the cause and find a solutionâ€?. Organized by Partnership for Safe Medicines, the aim of the national consultation meet was to build consensus on the methodology needed to study the volume of spurious and substandard drugs prevalent in the country. Participants included key government officials, regulatory bodies and civil society groups. Deputy Drug Controller General of India Dr D Roy said, â€œNo doubt technology can play a major role in tracking and tracing the menace but the need of the hour is to evolve a more holistic approach involving all stakeholders.â€? Eli Lilly, Boehringer sign deal Eli Lilly India and Boehringer Ingelheim India entered into an agreement specific to India to co-promote a portfolio of diabetes compounds, which are either in late-stage development or in the market. The collaboration includes Lilly's insulin analogue, Humalog (Lispro), which is already in the market in India, and Boehringer Ingelheim's oral anti-diabetic agent, Linagliptin, which is yet to be approved for marketing in India. The alliance will leverage the collective scientific expertise and business capabilities of two leading research-driven pharmaceutical companies to address patient needs arising from growing global diabetes epidemic. Since its launch in 2005, Lilly's Humalog range has become a significant player in the nearly $30 million Premix & Rapid insulin analog market, according to IMS Indian Pharmaceutical Audit, June 2011. Linagliptin is a dipeptidyl peptidase-4 (DPP-4) inhibitor discovered by Boehringer Ingelheim and developed as an oral once-daily single dose tablet for the treatment of Type 2 diabetes. It is already approved in the US, European Union and Japan, among other countries. â€œIndia is clearly a market with great need and huge potential for the treatment of diabetes,â€? said Mr Jacques Tapiero, president, emerging markets business area, Eli Lilly. â€œThis strategic alliance with Boehringer Ingelheim will significantly expand our commercial presence in India.â€? India Healthcare Excellence Awards At the third edition of the India Healthcare Excellence Awards 2011, Siro Clinpharm was awarded the Indian Clinical Research Organisation of the Year and Roche India was presented with the Indian Oncology Market Company of the Year. GlaxoSmithKline Pharmaceuticals won the award for the Indian Vaccine Market Company of the Year. Biocon was voted the Indian Biopharma Company of the Year. Mr Narayanan Suresh, group editor, BioSpectrum, who was part of the jury, gave away the award to Biocon. Jubilant Biosys was adjudged the Indian Contract Research Organization of the Year, the second time in running, after winning the same award in 2010. The awards were co-hosted by Frost & Sullivan and Alexandria Real Estate Equities. Novozymes to ramp up presence in India Novozymes, the world's largest producer of industrial enzymes, is planning to strengthen its position in the country following a twin strategy of enhancing its global portfolio and developing local solutions to gain further foothold in the India market. Sale of enzymes to industries in emerging markets is a strong growth driver for Novozymes. This is one of the reasons for the company to ramp up its presence in countries like India, Brazil and China. ]]> <![CDATA['We are scientific opportunists and not commercial opportunists']]> https://biospectrumindia.com/news/95/6008/we-are-scientific-opportunists-and-not-commercial-opportunists.html https://biospectrumindia.com/news/95/6008/we-are-scientific-opportunists-and-not-commercial-opportunists.html Mon, 14 Nov 2011 14:11:00 +0530 Mr Deepak Kapur Managing director, Indovax Incorporated in 1986, Indovax is a leading manufacturer of biologics in India. With a strength of about 350 personnel, the company, headquartered in Gurgaon, is at the forefront of development, manufacturing and marketing of poultry vaccines in India. It has a modern state-of-the-art facility spread across 14 acres in a completely poultry-free zone. The product portfolio of the company consists of viral and inactivated vaccines, including the Newcastle vaccine (Ranikhet vaccine), Gumboro vaccine (IBD), Marek's vaccine, infectious bronchitis vaccine, fowl pox vaccine, fowl cholera vaccine and the infectious coryza vaccine. In order to boost the supply of raw materials for vaccine production, the company is going to commission its new specific pathogen free (SPF) egg facility at Himachal Pradesh during the first week of November 2011, in a joint venture (JV) with a Dutch company, Gezondheidsdienst voor Dieren BV (GD). The JV called Immunetic Lifesciences will produce specific pathogen-free embryonated eggs and diagnostic reagents for customers in India and across the world. In an interview with BioSpectrum, Mr Deepak Kapur, managing director, Indovax, spoke about the company's growth, operations, competition, regulations and much more. Q With the commissioning of the new facility, do you expect to see an increase in the growth rate of the company? Mr Kapur: From the very beginning, we have been looking at sustainable growth. Over the last four-to-five years, we have been strengthening the company. We can also increase our production and fast track everything, but the credit will also go up eventually. We don't want that to happen. We want to focus on working properly and make our customers happy. The poultry industry is disorganized and vaccines can't be sold for cash. The most critical factor for the industry is the raw material in the form of SPF eggs. Therefore, to have a secure and unhindered supply, we will shortly commission a new SPF facility at Himachal Pradesh in a joint venture with a Dutch company, Gezondheidsdienst voor Dieren BV. By the end of the November 2011, the facility will be decontaminated, validated and subsequently launched for production. This project is being supported by the Dutch government. Q How do you view competition in the veterinary vaccine market? Mr Kapur: The other major player in the market includes Venkateshwara Hatcheries, which occupies 60 to 70 percent share of the market. The company has major advantages as they control 90 percent of poultry breeding and 60 percent of the broiler industry. However, notwithstanding the competition, we too have certain strong areas. We are strong in the eastern markets. We are unique in introducing small as well as long dosage packets of 100, 500 or 1,000. If somebody has a 500 chicken farm, then a dosage of 5,000 is less likely to be used in one go. Despite the fact that the small packets gobble up lot of space, we have decided to continue with the production, in order to benefit small-scale farmers. In the mid 1990s, the country faced a new challenge in form of inflammatory bowel disease (IBD), which is a highly immunosuppresive disease. The disease in their sub-clinical form attack certain organs of the bird and weaken the immune system gradually. The resulting 60 to 70 percent mortality caused chaos. Everybody was trying to solve the problem and international companies were selling products in India. Imports were happening at international price. To tackle this, we went to identify the root cause. Our researchers went to the field, isolated the virus and attenuated it to develop a product for the market. The industry still recognizes our collaborative efforts in this direction. Since the Indian government banned the import of specific pathogen-free, eggs which is a critical raw material, Indovax entered into a joint venture agreement with Gezondheidsdienst voor Dieren BV (GD), a Dutch entity, to establish in India a company called Immunetic Lifesciences in order to produce specific pathogen-free embryonated eggs and diagnostic reagents for customers in India and across the world. Q What is the overall market size of poultry vaccines in India? What is your share and how does the company operate? Mr Kapur: The size of the market is close to 150 to 160 crore. The market size depends on many conditions as there are no definite vaccines like in the case of humans. In India, the poultry vaccines are given on the basis of certain aspects such as challenging local conditions, and seasonal variations. Proper management also plays an important role. So, the requirements vary from time to time. Our company has an estimated overall national market share of over 25 percent and produces over four billion doses of vaccine annually, which cater to the needs of the domestic and international markets. We consider ourselves not as commercial opportunists but scientific opportunists. This effort is supported by a team of qualified scientists, who are drawn from diverse disciplines that include virology, microbiology, immunology, biotechnology, pathology and epidemiology. We develop vaccines which are suitable not only for India but also for South Asia and Asia Pacific countries. Poultry vaccines are doing well in both the domestic and the international markets. Depending upon the feedback from our sales team, we tackle the issues, out of which 99 percent are generally related to management, chicken feed or cold chain. However, in case there are any specific issues, our technical services team investigates and in case intelligent answers are not found, R&D takes up the challenge to probe it further. Q What about the regulations in veterinary vaccines? How are the comparisons drawn with human vaccines? Mr Kapur: The regulatory regime for veterinary vaccines is certainly evolving. I don't say that there are major hassles but certainly there are few grey areas. Vaccine production and manufacturing require strict regulations because of the involvement of various FDAs including that of the US, Japan or Europe. Usually, the regulators follow the schedule M of cosmetics and drugs act for GMP in poultry vaccines on the lines of human vaccines. However, there are few major differences that come into picture when we compare the two industries. For example the poultry vaccine is given in water, intra-nasal and through subcutaneous routes whereas in humans it is intramuscular. The dosage in case of poultry is 1,000 doses, 5,000 doses and 10,000 doses. The dosage and administration conditions in the two cases are different. Therefore, certain changes as far as regulations are concerned are definitely required. On many occasions, we have to identify these viruses themselves in order to attenuate them on field outbreak and convert them into vaccine candidate and conduct whatever tests are required for checking viability. The veterinary side is much advanced than the human side in a number of cases. Q What are the emerging challenges faced by the poultry industry? Mr Kapur: Chicken anemia is the significant problem faced by the industry. India is pretty much affected by it. It compromises the immune system and increases morbidity. Another big issue is the path type of infection of bronchitis. The avian influenza virus results in a good number of casualties. In high path avian influenza, the government has robust system and the birds are culled immediately but the real issue is with the low path strains, such as HPAI A (H5N1), which are more dangerous because of chances of getting into human workers. We can stop people but not the air. Avian influenza comes through migratory birds from Siberia and China that mix up with the local bird population. Our agro-climatic conditions are different and the diaspora of viruses have different pathogenecity in field than the ones in the US and Europe. For example, the Ranikhet (New Castle) disease has mild strains in Europe, whereas in India it is considered an endemic disease. Overseas, people use mild but inactivated vaccine which is costly, whereas in India the live vaccine is used because it is cheaper and is at a low risk of spreading. Therefore, it has to be handled with care. Rahul Koul in New Delhi ]]> <![CDATA['We want to outbid market growth']]> https://biospectrumindia.com/news/95/1630/we-want-to-outbid-market-growth.html https://biospectrumindia.com/news/95/1630/we-want-to-outbid-market-growth.html Mon, 14 Nov 2011 14:10:00 +0530 Mr Prantik Mukherjee Head, Merck Millipore Merck Milliopore, the life sciences division of Merck KGaA of Darmstadt, Germany, recently announced the launch of Merck Millipore India Innovation Awards (MMIIA). The program is the first-of-its-kind and is intended to recognize government-funded and not-for-profit research undertaken by scientists. In an interview with BioSpectrum, Mr Prantik Mukherjee, head of Merck Millipore, talks about the launch of MMIIA, the company's growth, challenges and opportunities, among other things. Q What is the objective behind the launch of Merck Millipore award? From my 20 years of experience in this industry, I can say that the scientists are doing a great job in advancing research in the field. However, they also face hiccups due to funding delays. Through this award, we want to bring scientists and Merck Millipore together for promoting innovation. The awards aim to acknowledge efforts of scientists who are working tirelessly to produce innovative research outside commercial research centers. Unlike other awards, the MMIIA hopes to celebrate, encourage and inspire innovation amongst India's scientific community in the life sciences sector. The idea is to promote research in areas such as green chemistry, medicinal chemistry, chemical and bioanalytics, proteomics, genomics, drug discovery and delivery, biomanufacturing, biomarkers and synthetic biology. Q How has the acquisition of Millipore helped Merck? What is the growth story so far? It has been only 18 months and we have had a very encouraging journey. Integration of these two leading brands has been rolled out globally and is still in process. One aim is to bring together two great organizations and helping us to establish a better and improved product profile for clients. We are now looking forward to making efforts to take this forward. Our focus has been to train people, innovate and update products. We have rapidly achieved great progress, but I think it is too early to talk about revenue figures. However, I would like to add that the figures have always remained above the market growth. Q How do you set yourself apart from competition in the market? We are strong in systems biology and can help scientists in this research. Besides that, we also supply pharma ingredient, filter validation and cartridge. Filter technology is the expertise of Millipore, whereas chemistry is the forte of Merck. With the brands coming together, we are trying to bridge the gap and make it our strength. Our competitors are only in one area of the process chain, whereas Merck Millipore is a complete solutions provider. This is our uniqueness in the competition that we face mostly from global competitors. It is also fair enough to have competition as without it life would be boring. Q What kind of challenges do you face as a biosupplier? India has tremendous growth opportunities, but we are still at the base of the learning curve. There is a big difference between the thinking of people in India and their western counterparts. Our challenge is to bridge that gap and leverage the opportunity. Our technology is to help scientists in India not only in India but even after they have moved out. As far as logistics are concerned, all developing countries, like India, are facing issues. However, we are setting up many processes to overcome this challenge. We are trying to ensure that goods reach clients as quickly as possible. Q What opportunities do you see in the markets of India and China? India and China are surely going to be big opportunity tickets. This is why companies want to invest here. My personal opinion is that India offers more security to manufacturers. The country offers advantages in terms of talent, IP protection and research. In case of China, we can say that it is more about volume, like raw material or APIs. China also has an active biosimilar model but I think India still has an edge. The recent example of various types of tie-ups: Biocon with Pfizer, and GSK with Strides Acrolabs and AstraZenca strengthen India's case. These can be stepping stones for furthering the industry's growth in India. Q What is the future outlook of the company? The future outlook is to outbid market growth and continue investments through the areas of production, regulation and application. These three areas will drive our business. Our focus is completely on business operation and catering to the changing needs of customers. Rahul Koul in NewDelhi ]]> <![CDATA[Nanomaterials to cure corneal blindness]]> https://biospectrumindia.com/news/95/1199/nanomaterials-to-cure-corneal-blindness.html https://biospectrumindia.com/news/95/1199/nanomaterials-to-cure-corneal-blindness.html Mon, 14 Nov 2011 13:17:00 +0530 A novel nanomaterial-based technology to solve corneal blindness due to endothelial diseases has been developed by an Indo-Japan consortium of stem cell scientists and nanomaterial experts. Dr Kazutoshi Haraguchi, director, Kawamura Institute of Chemical Research, Japan, presented this on the sixth anniversary of Nichi-In Centre for Regenerative Medicine, The NCRM NICHE 2011. These findings give a lot of hope to thousands of patients in India and other developing nations who suffer from isolated corneal endothelial disease, according to Dr Parikumar, an ophthalmologist and associate of NCRM. The present methodologies use one-donor eye for treating one patient eye, whereas our novel nanomaterials are capable of multiplying the corneal endothelial stem cells in the lab, and by using a nanosheet, they can be safely applied to the eye as proven in animal studies. The cells taken from one donor can be multiplied and could be used to treat more than one eye making this a revolutionary phenomenon called â€œan-eye-for-eyesâ€?, said Dr Abraham, director, NCRM. The lecture by Dr Haraguchi was in commemoration of the International Year of Chemistry 2011. India to double R&D expenditure India has decided to double the expenditure in research and development with major initiatives being taken by the country in super computing, material sciences, genomics, nano sciences and plant breeding techniques and synthetic biology. Minister of State for Science & Technology Dr Ashwani Kumar revealed the plans of the Indian government to double its R&D expenditure at the eighth annual meeting of STS Forum on Science & Technology in Tokyo. Borlaug Institute comes to India Named after Nobel laureate Dr Norman E Borlaug, the Borlaug Institute for South Asia (BISA) will be an international institute focussed on agricultural research and expected to attract R&D investment in the country. Indian agricultural research is set to receive a boost with the institute to be established by Mexico-based International Maize and Wheat Improvement Centre (CIMMYT). It will have centers in India at Ludhiana in Punjab, Pusa (Samastipur) in Bihar and Jabalpur in Madhya Pradesh. The project was officially launched by Agriculture and Food Processing Industries Minister Sharad Pawar on Oct 05, 2011, at New Delhi. Dr S Ayyappan, secretary of the Department of Agricultural Research and Education, and director general of the Indian Council for Agricultural Reserach and Dr Thomas A Lumpkin, director general, CIMMYT signed an MoU. The collaboration between two organizations will be intensified and defined through five-year 'Work plans for Scientific and Technical Partnership on Maize and Wheat Systems'. Funding and in-kind support will come from the Government of India and a consortium of international and regional, public and private investors. IVRI scouts for industry partners To meet the increased demand for the livestock vaccines and diagnostics in the country and the region, Indian Veterinary Research Institute (IVRI) has decided to transfer technologies developed by its researchers. The IVRI is looking for experienced companies interested in commercial production and marketing of its technologies and ensuring the availability of these vaccines and diagnostics for large-scale use. Along with bacterial and viral vaccines, the technologies available for transfer include diagnostic tools. Among the bacterial vaccines ready for transfer are multiple emulsion HS vaccine, Enterotoxiemia vaccine, Brucella abortus cotton strain-19 vaccine, Brucella melitensis vaccine, and Saponified haemorrhagic septicaemia (HS) vaccine. The viral vaccines include the live attenuated homologous Peste des petits ruminants (PPR) vaccine, Vero cell based goat pox vaccine, Vero cell based sheep pox vaccine and Swine fever virus cell culture vaccine. The various diagnostic tools developed by IVRI include the Tuberculin PPD, Mallein PPD, Johnin PPD, Brucella abortus â€“ SAT, Brucella abortus â€“ MRT, Brucella abortus â€“ RBPT, Brucella abortus â€“ Positive serum, Salmonella reagents, Caprine pleuropneumonia diagnostic kit, monoclonal antibody-based sandwich ELISA kit for PPR virus antigen detection and monoclonal antibody based competitive ELISA kit for PPR virus antibody detection, among others. ]]> <![CDATA[FDA approval for Strides' injections]]> https://biospectrumindia.com/news/95/2256/fda-approval-for-strides-injections.html https://biospectrumindia.com/news/95/2256/fda-approval-for-strides-injections.html Mon, 14 Nov 2011 13:13:00 +0530 Onco Therapies, a wholly owned subsidiary of Strides Arcolab, has received US FDA approval for Cladribine Injection of 1 mg/ml packaged in 10 mg/10 ml single-dose vials. Cladribine is part of the oncology portfolio licensed to Pfizer in January 2010 for the US market. The product is expected to be launched shortly and belongs to the group of cancer-fighting medications known as antineoplastics, and specifically to the group of antineoplastics known as antimetabolites. Strides Arcolab has also received US FDA approval for Clindamycin Injection, USP, an antibiotic used to treat bacterial infections. Clindamycin injection will be available in three single-dose vial sizes and in pharmacy bulk packaging. RMS-Regrow gets GMP certification Regenerative Medical Services, a leading biotechnology company in India focused on the delivery of the most advanced stem cell therapy treatment, received certifications for good manufacturing practices (GMP), good laboratory practices (GLP) and good clinical practices (GCP) from the British Standard Institution, an international accreditation body. The GMP, GLP and GCP certifications received by RMS-Regrow validate the procedures adopted and followed at RMS-Regrow. These certifications place RMS Regrow in the select league of companies that have been awarded such a global honor. â€œThis is a landmark achievement for us as this certification has come within the first two years of the company's operations since September 2009 after receiving its ISO 13485:2003. This significant milestone enables the company to advance the global commercialization of cellular therapies, live up to the commitment of exceeding customer expectations and maintaining manufacturing excellence,â€? said Dr Satyen Sanghavi, chief scientific officer at RMS. CryoSave gets WHO-GMP certificate Cryo-Save India, a subsidiary of the leading Europe-based family stem cell banking company Cryo Save Group NV, has become the first to receive the World Health Organisation's Good Manufacturing Practices (WHO-GMP) certification. Cryo-Save India is headquartered in Bangalore with a state-of-the art fully automated adult stem-cell storage facility. The WHO-GMP certification guarantees superior quality, safety and effectiveness in production. In the case of blood products like stem cells, the WHO-GMP guidelines govern every aspect of production and testing which includes construction, design and maintenance of the premises, qualification of equipment, extraction process, laboratory condition, component preparation and validation and cross contamination, mix-ups and labelling, that can impact the quality of the product. ]]> <![CDATA[Tracking Malaysia]]> https://biospectrumindia.com/news/95/2773/tracking-malaysia.html https://biospectrumindia.com/news/95/2773/tracking-malaysia.html Mon, 14 Nov 2011 13:05:00 +0530 Nandita Singh The author is Editor of BioSpectrum nanditas@cybermedia.co.in Malaysia is raring to go, on all fronts. The latest news about Malaysia that caught my attention pertains to the realty sector. A non profit government agency, Malaysia Property Incorporated (MPI), is reaching out to India with the intention of getting about $1.5 billion (Ringgit five billion) of Indian investment into the country's real estate sector over the next five years. It is quite visible that the Malaysian government has been making efforts on all fronts across all sectors and markets â€“ developed as well as emerging. I, myself, have witnessed some of these pitches being made at various international forums in the last five years. There have been some successes and some are on the way. Biotech, of course, remains a big focus area for the country, even though the take-off in terms of actual results in proportion to effort is debatable. Besides, what has come through, has taken a long time to come. However, the steps taken are all in the right direction and aligned with the reality of global economy. The biotech industry in Malaysia is not just about attracting investments it is also about developing the local industry and creating next generation jobs. Just to cite an example: Malaysia Debt Ventures (MDV) by December 2012 will give loans up to $16 million (RM 50 million) to support local biotech firms. The idea behind this effort is to help the small local biotechs in research, enabling them to undertake pre-commercialization projects. This debt-financing vehicle, MDV, mainly serves the information and communications sector from where it draws 70 percent of its customers. For biotech, MDV focuses on the BioNexus status companies. BioNexus Network is a web of biotechnology companies and organizations that leverage on existing facilities, infrastructure and capabilities of universities and research institutions throughout Malaysia. In Malaysia companies within this network are said to have BioNexus status. Currently, there are over 180 such BioNexus status companies in Malaysia and these receive a host of subsidies and other necessary support from the government. In another recent development, Malaysia has got together with Indonesia to jointly set up a fund to invest in technology start-ups in the region. Malaysia government's venture capital unit signed a memorandum of understanding (MoU) with the Indonesian Investment Agency for the purpose of establishing the fund, in October, this year. Mechanics of the fund are still being worked about. It is expected that this joint fund will boost high technology sectors across industries including information and communication technology, biotech, agri-biotech, and renewable energy among others. There are a number of other efforts as well, some underway and some on the agenda. And you can see most of this yourself in Kuala Lumpur at BioMalaysia 2011, later this month (November 21-23, 2011). Those who are unable to make it, can always catch the latest update on it with BioSpectrum. ]]> <![CDATA[Public funds spur innovation in Indian biotech]]> https://biospectrumindia.com/news/95/1239/public-funds-spur-innovation-in-indian-biotech.html https://biospectrumindia.com/news/95/1239/public-funds-spur-innovation-in-indian-biotech.html Mon, 14 Nov 2011 13:02:00 +0530 In the euphoria generated among the middle classes by the anti-corruption movement led by a â€œGandhian-in-the-makingâ€? Anna Hazare, the government and its activities have become the focus of widespread criticism. In fact, if one goes by the tone of the general public discourse, it is clear that this over-arching entity called the government cannot get anything right. Is it really so? Can't governments get anything right? Are all government initiatives doomed to fail? Just consider three case studies presented in the November issue of BioSpectrum under the Public Private Partnership (PPP) series. Affordable healthcare is a priority area for fund allocation by the government's Department of Biotechnology (DBT). So, when Delhi-based Amar Immunodiagnostics applied for funds to develop kits to diagnose all autoimmune diseases, the DBT officials advised the company to focus on some key diseases. The company got a grant of 13 lakh in April 2011 and on the DBT's advise has developed a kit to quickly diagnose Celiac disease, a rare category of autoimmune disorder associated with tissue trans glutaminase. In just six months, the company has developed a kit that is now undergoing final quality tests. The experience has been so valuable that now the company is confident of developing kits against a wide range of autoimmune diseases. Can anyone find fault with the advise given by the government representatives? In the second case, Chennai-based Tergene Biotech got a grant of just 15 lakh from DBT in November 2010 to make affordable pneumococcal conjugate vaccine. In less than a year, the task has been accomplished successfully and the company is now setting up, on its own, a manufacturing facility which will be operational by mid-2013. The India-made vaccine is expected to be sold at one-third of the imported vaccine which costs nearly 3,800 per dose. Infants need four doses of this vaccine to get protection against the pneumococcal infection. The third case is even more interesting. Ganit Labs, a not-for-profit company has been supported by the Government of Karnataka, its agencies and a private company, Strand Life Sciences. Ganit started operations in February 2011, and in September, it unveiled the complete genome of neem, a highly useful plant widely grown in India. And the entire data has been instantly made available for use by scientific community around the world. The information gained from the sequencing data will be very useful to make more studies related to one of its most useful compound, azadirachtin, and other compounds for their medicinal and pesticidal properties. These three case studies indicate that the officials were acting in the long-term public interest and were even prepared to face flak if the projects ended in failure. All the three had succeeded. Imagine the criticism the official would face from auditors if any of these projects had not delivered and motives attributed to the support to such technology development projects in the private sector. Even in the home of free market economy, the government continues to spend billions of dollars for technology development. Some estimates state that nearly half the technologies that reach the markets are developed initially using the US government funds. We, at BioSpectrum, are adding our bit by recognizing the best such efforts through the PPP mode in the biotech sector during the annual BioSpectrum Awards program in December. The details will reach you later this month. Narayanan Suresh Chief Editor sureshn@cybermedia.co.in ]]> <![CDATA[Game Changers in Drug Discovery & Development: BioSpectrum Technology Forum 2011 â€“ Bangalore & Mumbai]]> https://biospectrumindia.com/news/95/2436/game-changers-in-drug-discovery-development-biospectrum-technology-forum-2011-bangalore-mumbai.html https://biospectrumindia.com/news/95/2436/game-changers-in-drug-discovery-development-biospectrum-technology-forum-2011-bangalore-mumbai.html Mon, 14 Nov 2011 12:32:00 +0530 After the thumping success of the BioSpectrum Technology Forum (BSTF) in Goa in 2010, BioSpectrum takes the event to two cities - Bangalore and Mumbai - in 2011 What is BSTF Every year, BioSpectrum brings together research heads and scientists of biotechnology and pharmaceutical companies on a common platform to enable industry leaders to interact and share their views and opinions. The BioSpectrum Technology Forum was taken to two cities this year to make it more accessible to delegates. While the first leg of the event was held on September 21 at Chancery Pavillion in Bangalore, the second leg was held on September 23 at Leela Palace in Mumbai. West Pharmaceutical Services sponsored the Mumbai event. Elaborating the vision of the BSTF and role of BioSpectrum, Mr Narayanan Suresh, group editor, BioSpectrum, said in his welcome address, â€œBioSpectrum mirrors the views of the industry and works closely with its leaders. Earlier, we were involved in policy advocacy and regulatory change campaigns. We then looked at moving to the next level and we did this by organizing events such as the BSTF that encourage interaction with industry leaders at different levels.â€? The theme of BSTF 2011 The theme for this year's forum was 'Game Changers in Drug Discovery & Development'. This topic was covered with five sessions - 'Next Generation Innovation', 'Computer-aided Drug Discovery', 'Strategies to Strengthen the Drug Pipeline' and 'Strategic Outsourcing of Drug Discovery: How to Leverage the Opportunity'. Drug discovery is an exciting area. In our BioSpectrum Asia-Pacific CRO Survey, many indicated that they will focus on drug discovery in the years to come and will send their work to Asia Mr Narayanan Suresh group editor, BioSpectrum Session I: Stem Cells & Gene Therapy Panelists Bangalore: Dr Rakhi Pal, scientist, Advanced Neuro-Science Allies, Mr Ambar Rao, director, Cryo StemCell and Mr Narayanan Suresh, group editor, BioSpectrum (moderator) Mumbai: Ms Dipta Chaudhury, program manager, pharma and biotech practice, South Asia and Middle East, Frost & Sullivan (moderator); Dr Milind Antani, head of pharma & life sciences, Nishith Desai Associates; and Dr Chandra Vishwanathan, head, regenerative medicine, Reliance Life Sciences Dr Rakhi Pal, scientist Advanced Neuro-Science Allies A lot of animal and clinical trials are available to prove their proliferation capacity. Scientists have tagged stem cells that were injected to show that neural stem cells from the injected site migrated to lesion site. Using imaging techniques, they have shown that the injected stem cells differentiated into astrocytes and neural cells. Parkinson's disease animal studies have shown increase in dopaminic output, and in vitro studies have shown that mesenchymal stem cells can differentiate into dopamine terminals and release dopamine. Mr Ambar Rao, director Cryo StemCell When we started cell banking, the level of understanding among the clientele was very poor or did not exist at all. Other challenges we faced were the logistics and regulation troubles. Over a period of time, we were able to establish a good stream of revenue with an increase in the number of clientele banking stem cells. Recently, we successfully transported stem cells for transplant to the Gujarat Cancer Research Institute. The sample was shipped in liquid nitrogen. We follow stringent norms in handling our products and we have, so far, done around 80-odd transplants for liver cirrhosis, myocardial infraction and other conditions where our application was put to use. Dr Chandra Vishwanathan, head regenerative medicine, Reliance Life Sciences Science is changing and so is our understanding (of it). It was presumed that stem cells of the brain and the liver did not have regenerative qualities but now they are found to have such capabilities but in limited capacities. This provides some hope. The period between 1985 and 2002, known as the regenerative period I or phase- I, was dominated by the US because of excessive funding. Phase-II is the period after 2002 when stem cell research moved beyond the US to countries in Asia, such as Korea, Japan and India. It clearly shows that we are maturing in our understanding of stem cell, countries are investing in this field and governments are taking interest in funding. Dr Milind Antani, head of pharma & life sciences Nishith Desai Associates There is no law in India. There are guidelines that are not binding on the company or an individual. It is left to them to follow the guidelines. As far as the concept of informed consent for clinical trial participants or the receiver of stem cell therapy goes, it should not be just a piece of paper but should hold significant importance in India. This is a challenge and is often ignored by doctors in India. Should India shy away from stem cell research for lack of regulations? Panelists suggested the contrary and said India should be engaged in more research and the absence of a proper regulatory framework should not be a hindrance to commence future research work in the field. Too many rules will throttle research was the opinion. Session II: Next Generation Innovation Panelists Bangalore: Dr Pradip Majumder, CSO, Mitra Biotech; and Dr Binay Panda, chief officer and head, Ganit Labs Mumbai: Dr Pradeep Nagalkar, head-quality control, Haffkine Bio-Pharmaceutical Mr Pradip Majumder, CSO Mitra Biotech By 2030, 11 million people will die of cancer, which means every year a population the size of Bangalore or Delhi is dying. We need to have some technology or device that can tell us which is the best way to select a particular medicine for a particular patient. At Mitra Biotech, we have developed Oncoprint, a technology that predicts the outcome of a particular medicine on a particular patient. We can predict whether a particular drug is functional, not functional or partially functional. We can also predict the functional, pathological and genetic outcome. But of course innovation to application is not a one-day thing, it is a marathon. Mr Binay Panda, chief officer and head Ganit Labs Today, we have the ability of using next generation sequencing to actually capture and study each step of the central dogma to interrogate and analyze it. We do not have to create new drugs, we have to reposition the drugs that are already in the market. The big pharma companies are repositioning drugs by using pharmacogenomics model. Bioinformatics is the buzz word in India. We need to analyze the genome which is relevant to the efficacy of the drug or come up with a complete different methodology to target a different pathway that was absent before. Dr Pradeep Nagalkar, head-quality control Haffkine Bio-Pharmaceutical It is only in the last two to three decades that novel technologies in vaccines, such as conjugation, recombinant technologies and virus-like particle methods, were developed and found to be successful. The industry is likely to change dramatically over the next five to 10 years as many promising innovative technologies will reach the market. Adoption and application of new technologies must be driven by their ability to generate revenues and contribute to growth of a business by meeting important unmet needs. Technologies such as DNA vaccines, recombinant vectors, and alternative routes of administration address manufacturing, and scalable needs are the way ahead. Naked DNA is both cost-efficient and scalable since DNA can be manufactured rapidly. This approach could be particularly useful as a response to a pandemic outbreak. Session III: Computer-aided Drug Discovery Panelists Bangalore: Dr Kas Subramanian, CSO, Strand Life Sciences, and Dr Vellarkad N Viswanadhan, head, Department of Computational Chemistry at Jubilant Biosys Mumbai: Dr Urmila Kulkarni-Kale, information scientist, Department of Bioinformatics, University of Pune; Dr Abhay Jere, associate vice-president, life sciences domain, Persistent Systems; and Dr Chetan Desai, director- operations, Karmic Life Sciences (moderator) Dr Vellarkad N Viswanadhan, head, Department of Computational Chemistry Jubilant Biosys Chemoinformatics is a critical part of computer-aided drug discovery that plays an important part in target drugability and validation. Early focus on candidate drug likeness properties, like potency and validation, was possible using informatics. Drug modeling has evolved to predict not only the potency in enzymes but also other chemical properties. Computer-aided drug discovery is also making an impact in the biological field, especially in the domain of monoclonal antibodies. Fragment-based drug design approach is what we follow where the idea is to look at the active site of the enzyme and see what specific functionality or groups bind to different targets. This concept is further optimized to give rise to a candidate drug. Dr Chetan Desai, director, operations, Karmic Life Sciences Over the years, drug discovery has seen a paradigm shift and now we see more focus on target-based therapies. Informatics had a critical role to play in the new age of drug discovery. Dr Kas Subramanian, CSO Strand Life Sciences The way drugs are being developed, cost of every successful drug is rising, while the number of new drugs is decreasing, which is unsustainable. The advantage of simulation is that once you run a simulation in your predictive model, it will tell you how every other sub system is behaving. Just to give an example, we designed a system to predict the impact of different therapeutic doses it shows which dose will have the maximum impact. There will be certain hypotheses that will fall off as a consequence of integrating what you know about the disease and everything else that we already know. There will be cases when you cannot distinguish. At this point, we have to carry both the hypothesis along till we get to the point where distinguishing between them becomes important, but once in this format, it will enable one to distinguish between two competing hypothesis, so we have to manage uncertainty as a part of the process. Dr Urmila Kulkarni-Kale, information scientist, Department of Bioinformatics, University of Pune Bioinformatics is a young discipline and recently completed 25 years of existence in India. It has bridged the gap between life sciences scientists, physicists and IT professionals. Dr Abhay Jere, associate vice president-life sciences domain, Persistent Systems We, at Persistent Systems, believe that personalized genomics is the way ahead and the future of science. Next generation sequencing has various applications, which include DNA analysis, Transcriptome and RNA, Metagenomics, Agrigenomics, ChIP and Methylome Sequencing, Small RNA sequencing and bacterial and microbial sequencing. When we sign MoUs with universities, we organise meetings with students so that they understand the seriousness of the project. What does the future behold? Dr Urmila Kulkarni-Kale said, â€œBioinformatics has become an integral part of the life sciences industry. Immunoinformatics is, on the other hand, growing. As far as funding in both these fields are concerned, there is no problem.â€? She said there should be more collaborations between the academia and the industry. She also spoke on game changers in vaccine design and discussed the issues surrounding design and development of vaccines and put emphasis on reverse vaccinology. Session IV: Strategies to Strengthen Drug Pipeline Panelists Bangalore: Dr Kavita Iyer, COO, InbioPro, and Dr V N Balaji, CSO, Jubilant Biosys Mumbai: Dr H Sivaramakrishnan, CSO, Piramal Life Sciences; Dr Sanjeev Saxena, CEO, Actis Biologics; and Mr Rajiv Pillai, vice-president, life sciences practice, Ernst and Young (moderator) Dr Kavita Iyer, COO InbioPro The total share of pharmaceutical market is growing at 21 percent and with many products going off-patent, sales of biosimilar products is estimated to be at $107 billion. Biobetter development is something that we will concurrently do along with biosimilars. There might be this misconception that reduced research and development costs will translate into reduced pricing of the drugs, but that is not the case. The idea of biobetters is not that they are cheaply priced as they can cost up to 120 percent to 150 percent of the innovator brand unlike biosimilars that are sold at less than 50 percent of the innovator brand. Dr VN Balaji, CSO, Jubilant Biosys Target is most important for drug discovery. People have spent billions in accessing targets, many of which companies are no longer in operation or have diversified. Most of the targets discovered so far are from the academia and not the industry, and that too after rigorous research. Need for validated drug targets will help drug discovery. Different validatory targets at cellular level and tissue level with appropriate biomarkers is the goal to find new targets. Mr Sanjeev Saxena, CEO, Actis Biologics Indian biotech is still in its nascent stage. A lot of work is on in Biopharma but in the process we are creating a human resource pool, which is important for the discovery and development of new molecules. Funding for drug discovery is still a challenge, and there is a dire need for the investor community to change their mindset towards the biotechnology industry. Investors mainly look at RoIs and refrain from investing in biotech because of huge time lines. They need to realize that returns in biotechnology can be huge. Dr H Sivaramakrishnan, CSO, Piramal Life Sciences Despite a depletion in drug pipeline, in 2010, 28 new entities were accepted by the USFDA. Till June 2011, around 15 NCEs have already been approved by the FDA. People have realized where they went wrong 15 years ago when research in target-based therapies started and they have made a lot of progress since then. I am confident that the industry will go up in the coming years. Mr Rajiv Pillai, vice-president, life sciences practice, Ernst and Young From 2005, the growth of the pharma industry has been tapering. Last year, the FDA approved 25 products, majority of which were biologics. The prediction is that around 40 to 50 percent of products in the future will be biologics and today, a lot of work on them is taking place. Collaborations needed Panelists strongly recommended more industry-academia collaborations in India. A time would come when the Big Pharma would just be involved in phase III and marketing of products, said the panelists. This is where India has an opportunity because the country is home to a rich pool of skilled talent. Mr Rajiv Pillai mentioned, â€œA lot depends on the way drugs are positioned to the investor community. There are ways and models to align a product pipeline which would appeal to the investor community.â€? Session V: Strategies to Strengthen Drug Pipeline Panelists Bangalore: Mr Ajay Bharadwaj, founder, Anthem Biosciences; Dr Ram K H, managing director, SMO Clinical Research; Dr Surinder Kher, CEO-Asia, Ecron Acvunova (moderator); and Mr Mohan Pandey, head, operations and project management, Biocon BMS R&D Center, Bristol-Myers Squibb India Mumbai: Dr Bharat Doshi, independent clinical research consultant; Dr Arun Bhatt, president, ClinInvent; Mr Apurva Shah, co-founder and group managing director, Veeda Clinical Research; Dr Supriya Desai, associate director, medical affairs and safety management, Diagnosearch; Mr Rajendra Talele, vice-president, Clinical Operations â€“ Asia and Europe, Siro Clinpharm; and Mr Sujay Shetty, partner-pharmaceuticals and life sciences, PricewaterhouseCoopers (moderator). Mr Ajay Bharadwaj, founder, Anthem Biosciences With India and China strengthening their patent laws, there is explosive growth of CROs in these countries. Understanding the needs of the potential client, creating value for clients, maintaining deadlines and keeping egos out of conversation are prime factors that would help create a successful venture. The CRO landscape for the next five years will include integrated medicinal chemistry and supporting biology, enabling novel technologies, and the CROs will eventually mature into contract innovation services for survival. Dr Ram K H, managing director, SMO Clinical Research With an increase in preferred suppliers and with partnerships becoming stronger, joint ventures and real strategic partnerships have increased. Multinational companies have started their ventures and have slowly stratified into different sectors, like data management, with strategic alliances. With our abundant skills and English-speaking ability, we can expect more business opportunities. Mr Mohan Pandey, head, operations and project management, Biocon BMS R&D Center, Bristol-Myers Squibb India Pharma, along with other industries, will face some challenges, but the point is how we fight this challenge. Countries that have spent more than two percent of GDP in R&D are most prosperous. Innovation will create prosperity, and it is time for innovation to globalize itself. Export-derived income for pharma has been increasing steadily, and R&D outside home-base has increased. Perhaps because of this, the pharmaceutical industry has been able to maintain superior returns compared to others. It is also globalizing, partnering and outsourcing and this has helped pharma companies to maintain good returns on investment. (The views expressed by Mr Mohan Pandey are his personal views. He attended the event in his personal capacity and was not representing the views of Bristol-Myers Squibb) Dr Surinder Kher, CEO-Asia, Ecron Acvunova There have been public-private partnerships in the last five-to-seven years, especially with the Department of Biotechnology, in creating centers of excellence. The industry has to be forthright and come forward with its innovation and ideas. Although there are job cuts happening in the pharmaceutical industry, there is also outsourcing that is countering this action. The concept of research has to change significantly and that has already started happening. Over a period of time, this domain will change and we are looking forward to it. Dr Arun Bhatt, president, ClinInvent There are three challenges for India: site, infrastructure and ethics committee support. We need to have a strong pharmacovigilance. This apart, I feel that we have challenges in the form of three 'R's - recession (which has been sorted), regulatory structures and, lastly, publicity by reporters. Mr Apurva Shah, co-founder and group managing director, Veeda Clinical Research India is on the right path of drug discovery but there needs to be adequate government support in terms of conducive policies and regulatory framework. Indian scientists have a zeal and passion that is different from others. Government policies have killed research in drug discovery in India. The opportunity is in conducting niche clinical trials. [image_library_tag 922/44922, height="200" width="300" alt="Mr Rajendra Talele," align="left",default] Mr Rajendra Talele, vice-president, clinical operations â€“ Asia and Europe, Siro Clinpharm India has a huge talent pool and I feel the opportunities lie in support services required for clinical trials, like medical writing, statistics and data analysis. Dr Supriya Desai, associate director, medical affairs and safety management, Diagnosearch There are opportunities in medical writing for defining protocols, benchmarks and standards for India. There is a dearth of medical writers in the country and we need to train more people. India is losing out on development of new treatments, IP knowledge, new drugs because early phase clinical trials are not allowed in the country. Also, the regulators needed to be trained and that they needed to realize the companies' loss of face due to delay in approvals for trials. Mr Bharat Doshi, independent clinical research consultant The present scenario in India poses some good opportunities for India but the challenges are many. Regulations are a challenge and there needs to be improvisation of the type of trials. I see a lot of opportunities in conducting trials for niche therapeutic areas. Negative publicity for CRO industry Panelists were of the view that the CRO industry has become the target of negative publicity by the media and the government. This was in the light of pharmaceutical and CRO companies being pulled up by the DCGI and reports of deaths related to clinical trial appearing in the media. Mr Apurva Shah said, â€œAs an industry, we are not doing anything. Association on Clinical Research Organizations (ACRO) is in talks with the government to put things into perspective.â€? var imgarray= new Array(); var loadarray= new Array(); imgarray[0]="http://biospectrumindia.ciol.com/images/content/2011/nov/BSTF DSC_2827.png"; imgarray[1]="http://biospectrumindia.ciol.com/images/content/2011/nov/BSTF DSC_2836.png"; imgarray[2]="http://biospectrumindia.ciol.com/images/content/2011/nov/BSTF DSC_2852.png"; imgarray[3]="http://biospectrumindia.ciol.com/images/content/2011/nov/BSTF DSC_2857.png"; imgarray[4]="http://biospectrumindia.ciol.com/images/content/2011/nov/BSTF DSC_2863.png"; imgarray[5]="http://biospectrumindia.ciol.com/images/content/2011/nov/BSTF DSC_2864.png"; imgarray[6]="http://biospectrumindia.ciol.com/images/content/2011/nov/BSTF DSC_2877.png"; imgarray[7]="http://biospectrumindia.ciol.com/images/content/2011/nov/BSTF DSC_2884.png"; imgarray[8]="http://biospectrumindia.ciol.com/images/content/2011/nov/BSTF DSC_2902.png"; imgarray[9]="http://biospectrumindia.ciol.com/images/content/2011/nov/BSTF DSC_2905.png"; imgarray[10]="http://biospectrumindia.ciol.com/images/content/2011/nov/BSTF DSC_2906.png"; imgarray[11]="http://biospectrumindia.ciol.com/images/content/2011/nov/BSTF DSC_2919.png"; imgarray[12]="http://biospectrumindia.ciol.com/images/content/2011/nov/BSTF DSC_2937.png"; imgarray[13]="http://biospectrumindia.ciol.com/images/content/2011/nov/BSTF DSC_2941.png"; imgarray[14]="http://biospectrumindia.ciol.com/images/content/2011/nov/BSTF P1011953.png"; imgarray[15]="http://biospectrumindia.ciol.com/images/content/2011/nov/BSTF P1011954.png"; imgarray[16]="http://biospectrumindia.ciol.com/images/content/2011/nov/BSTF P1011961.png"; imgarray[17]="http://biospectrumindia.ciol.com/images/content/2011/nov/BSTF P1011965.png"; imgarray[18]="http://biospectrumindia.ciol.com/images/content/2011/nov/BSTF P1011974.png"; imgarray[19]="http://biospectrumindia.ciol.com/images/content/2011/nov/BSTF P1011987.png"; imgarray[20]="http://biospectrumindia.ciol.com/images/content/2011/nov/BSTF P1011990.png"; imgarray[21]="http://biospectrumindia.ciol.com/images/content/2011/nov/BSTF P1011999.png"; imgarray[22]="http://biospectrumindia.ciol.com/images/content/2011/nov/BSTF P1012003.png"; imgarray[23]="http://biospectrumindia.ciol.com/images/content/2011/nov/BSTF P1012018.png"; imgarray[24]="http://biospectrumindia.ciol.com/images/content/2011/nov/BSTF P1012035.png"; imgarray[25]="http://biospectrumindia.ciol.com/images/content/2011/nov/BSTF P1012064.png"; imgarray[26]="http://biospectrumindia.ciol.com/images/content/2011/nov/BSTF P1012065.png"; imgarray[27]="http://biospectrumindia.ciol.com/images/content/2011/nov/BSTF P1012085.png"; imgarray[28]="http://biospectrumindia.ciol.com/images/content/2011/nov/BSTF P1012087.png"; imgarray[29]="http://biospectrumindia.ciol.com/images/content/2011/nov/BSTF P1012097.png"; imgarray[30]="http://biospectrumindia.ciol.com/images/content/2011/nov/BSTF P1012104.png"; imgarray[31]="http://biospectrumindia.ciol.com/images/content/2011/nov/BSTF P1012106.png"; Prev Next var slide; document.onload=setting(); function setting() { slide=document.getElementById('pic'); slide.src=imgarray[0]; } /*-------------------------------------------create image space in mem*/ for (var j=0; j ]]> <![CDATA[BioSpectrum Awards 2011: Jury meets to decide winners]]> https://biospectrumindia.com/news/95/1598/biospectrum-awards-2011-jury-meets-to-decide-winners.html https://biospectrumindia.com/news/95/1598/biospectrum-awards-2011-jury-meets-to-decide-winners.html Mon, 14 Nov 2011 12:29:00 +0530 BSI Awards 2011 Jury agreed to the proposal of instituting the Public-Private Partnership Excellence Award to recognize and encourage innovation In deep deliberation: BioSpectrum Awards 2011 Jury at work The jury meeting for the BioSpectrum Awards 2011 took place in Mumbai at the corporate headquarters of Glenmark Pharmaceuticals in October. In line with the tradition that the winner of the previous Person of the Year Award chair the meeting, Mr Glenn Saldanha, chairman and managing director of the company, who was felicitated with the BioSpectrum Person of the Year Award in 2010, played host. This has been the norm since the BioSpectrum awards were conceptualized in 2003. For the past seven years, the awards have honored achievements and contributions of industry stalwarts and given impetus to companies to leave their mark in the sector. Commenting on India's position in the innovation landscape of the industry, Mr Saldanha said, â€œInnovation is the way forward for India if it needs to compete with other global companies. However, it will not be a cakewalk.â€? The meeting began with BioSpectrum Group Editor Mr Narayanan Suresh giving a brief introduction on the vision and goals of BioSpectrum Awards since its inception in 2003 and the processes to be followed during the course of the meeting. This year too, the jury members deliberated on the shortlisted nominees for each category. They zeroed in on the winners after two hours of discussions on the nominations. The nominees for this year were shortlisted on the basis of their performances over the past 12-18 months (excluding the Lifetime Achievement Award). Keeping in tune with suggestions of the industry and to encourage innovation in research, BioSpectrum proposed institution of the Public-Private Partnership Excellence Award this year. The award will honour and encourage companies that, along with the government, are involved in novel and revolutionary work. The jury members applauded BioSpectrum for this initiative which could go a long way in encouraging budding entrepreneurs. Winners were evaluated on the basis of their performances, achievements, their impact in shaping the biotechnology industry in India, role in fostering innovation in their respective companies and the industry at large and impact of their work in the years to come. The annual awards gala will be hosted in Bangalore in December 2011 and will see a gathering of top-notch stakeholders from all segments of the biotechnology industry. Make sure you are there to congratulate the winners. For invitation to the Award ceremony drop a mail to piyushac@cybermedia.co.in. The winners will be profiled in the December issue of the publication. BIOSPECTRUM JURY AWARDS 2011 Lifetime Achievement Award Person of the Year Entrepreneur of the Year Product of the Year Public-Private Partnership Excellence Award India Market Survey-based BIOSPECTRUM-ABLE INDUSTRY AWARDS 2011 BioSpectrum-ABLE BioPharma Company of the Year 2011 BioSpectrum-ABLE BioIndustrial Company of the Year 2011 BioSpectrum-ABLE BioServices Company of the Year 2011 BioSpectrum-ABLE BioAgri Company of the Year 2011 BioSpectrum-ABLE BioInformatics Company of the Year 2011 BioSpectrum-ABLE BT School of the Year 2011 (Public) BioSpectrum-ABLE BT School of the Year 2011 (Private) BIOSPECTRUM AWARDS 2011 JURY Jury chairman Mr Glenn Saldanha, chairman and MD, Glenmark, & BioSpectrum Person of the Year 2010 Jury members Dr GD Yadav, vice-chancellor, ICT Mumbai Dr SD Ravetkar, senior director, Serum Institute of India, Pune Mr Vishal Gandhi, vice-president, Life Sciences & Technology, Yes Bank, New Delhi Mr Sandeep Sahney, managing director, Genzyme India, Gurgaon Mr G Kochu Sankar, vice-president, Strategic Business Unit, Spinco Biotech, Chennai Ms Deepanwita Chattopadhyay, MD & CEO, IKP Knowledge Park, & director, IKP Investment Management Company, ICICI Knowledge Park, Hyderabad Dr Rashmi Bharbhaiya, CEO, Advinus Therapeutics, Bangalore Dr Arun Chandavarkar, COO, Biocon, Bangalore Mr Narayanan Suresh, group editor, BioSpectrum var imgarray= new Array(); var loadarray= new Array(); imgarray[0]="http://biospectrumindia.ciol.com/images/content/2011/nov/Jyry BioSpectrum.png"; imgarray[1]="http://biospectrumindia.ciol.com/images/content/2011/nov/Jyry DSC_0027.png"; imgarray[2]="http://biospectrumindia.ciol.com/images/content/2011/nov/Jyry DSC_3466.png"; imgarray[3]="http://biospectrumindia.ciol.com/images/content/2011/nov/Jyry DSC_3468.png"; imgarray[4]="http://biospectrumindia.ciol.com/images/content/2011/nov/Jyry DSC_3473.png"; imgarray[5]="http://biospectrumindia.ciol.com/images/content/2011/nov/Jyry DSC_3474.png"; imgarray[6]="http://biospectrumindia.ciol.com/images/content/2011/nov/Jyry DSC_3476.png"; imgarray[7]="http://biospectrumindia.ciol.com/images/content/2011/nov/Jyry DSC_3477.png"; imgarray[8]="http://biospectrumindia.ciol.com/images/content/2011/nov/Jyry DSC_3481.png"; imgarray[9]="http://biospectrumindia.ciol.com/images/content/2011/nov/Jyry DSC_3495.png"; imgarray[10]="http://biospectrumindia.ciol.com/images/content/2011/nov/Jyry DSC_3499.png"; imgarray[11]="http://biospectrumindia.ciol.com/images/content/2011/nov/Jyry DSC_3501.png"; imgarray[12]="http://biospectrumindia.ciol.com/images/content/2011/nov/Jyry DSC_3502.png"; imgarray[13]="http://biospectrumindia.ciol.com/images/content/2011/nov/Jyry DSC_3505.png"; Prev Next var slide; document.onload=setting(); function setting() { slide=document.getElementById('pic'); slide.src=imgarray[0]; } /*-------------------------------------------create image space in mem*/ for (var j=0; j ]]> <![CDATA[Can India's Bayh-Dole Act replicate the US success story?]]> https://biospectrumindia.com/news/95/1982/can-indias-bayh-dole-act-replicate-the-us-success-story.html https://biospectrumindia.com/news/95/1982/can-indias-bayh-dole-act-replicate-the-us-success-story.html Mon, 14 Nov 2011 12:23:00 +0530 The Protection and Utilization of Public Funded Intellectual Property (PUPFIP) Bill, 2008, introduced in Parliament seeks to foster innovation and protect intellectual property of inventions, but can it have the same impact as the Bayh-Dole Act had in the US? BioSpectrum takes stock of the pros and cons of the Bill, its current status and the debate surrounding it. The report also features articles by legal and intellectual property law experts on the PUPFIP Bill. A Bill full of promises Industry-academia tie-ups to foster innovation Will it fast track research? Will PUPFIP Bill inspire innovation? COLUMNS: A balancing art between commercial, basic research required Rahul Dev, MS, MBA, LLB, patent & trademark attorney Need to balance revenue generation, financial incentives Mr Kanikaram Satyanarayana, head, intellectual property rights unit, Indian Council of Medical Research A promising venture or a flawed legal transplant? Mr Shouvik Kr Guha, BA, LLB, research associate Role of law firms after Utilisation of Public Funded Intellectual Property Bill 2008 becomes an Act Ms Sunita K Sreedharan, lawyer, patent agent & CEO, SKS Law Associates, New Delhi ]]> <![CDATA[Will PUPFIP Bill inspire innovation?]]> https://biospectrumindia.com/news/95/2668/will-pupfip-bill-inspire-innovation.html https://biospectrumindia.com/news/95/2668/will-pupfip-bill-inspire-innovation.html Mon, 14 Nov 2011 12:22:00 +0530 The Protection and Utilization of Public Funded Intellectual Property (PUPFIP) Bill would not only create awareness about intellectual property but would also encourage a culture of innovation in India. One of the objectives of the Bill remains incentivizing research, thus increasing the responsibility of the researchers and universities to innovate. Traditionally, academic research has concentrated on elucidating the fundamental aspects of the respective scientific disciplines, whereas industrial research has been more product-driven. The authors of the Bill believe that academia currently lacks the necessary impetus required to generate intellectual property that can be used by the industry. The PUPFIP Bill aims to bridge the gap between industry and academia by providing researchers with incentives such as royalties to conduct innovative research that can add value to the society. However, the question remains, whether the adoption of a goal oriented research strategy will suit the academia and not destroy its ideologies. It is imperative, especially in the public health sector, to translate disease related research carried out in the academic institutions into suitable diagnostics and therapies, for the benefit of the people. The PUFPIP Bill is being looked at as the trigger that encourages scientists to work towards translating their research into products or closely collaborate with the industry to do the same. The US experience In the US, the Bayh-Dole Act is responsible for spurring academia industry relations, thus aiding the biotechnology industry to grow in leaps and bounds. Some of the best cited examples of products that have resulted from technology transfer include an artificial lung surfactant for babies born with respiratory distress system (University of California), a new treatment for Crohn's disease and other inflammatory bowel diseases (Washington University in St. Louis) and a haemophilus B conjugate vaccine (University of Rochester). The rDNA technology The most important innovation in the biotechnology arena, post the implementation of the Bayh-Dole act in the US, is that of recombinant DNA technology that was co-developed by Stanford University and the University of California. In this case the innovation was so ground breaking that it not only allowed the universities to earn sizable licensing incomes (Stanford and the University of California system accrued $255 million in licensing revenues), but also gave rise to whole bunch of start-up biotechnology companies, which manufactured products based on this technology. Much of the licensing income was subsequently invested in research and infrastructure. The Cohen-Boyer patent thus became the gold standard for universities to transfer innovative technology to the industry. However, opinion remains divided on whether these innovations were inspired because of the enactment of the law or would have seen the light of the day even without its help. Hopes of quality work Dr Virendra Chauhan, director, International Center for Genetic Engineering and Biotechnology (ICGEB), New Delhi, says, â€œInnovation does not always mean creating something new from scratch. It could also be described as a good quality imitation, which is better in terms of quality and cost.â€? By designing a transparent process to facilitate effective transfer of technology, the PUPFIP Bill aims to provide a platform for innovators from research institutes, to market and license their inventions to the industry. This would serve as an assurance to the innovators, that their inventions would yield them some profitable returns, thus further providing the impetus to innovation. It is hypothesized that if basic research results can be purchased by would-be developers, commercial innovation will be accelerated. This Bill is not directed at only large and well-established universities, but also at small and medium-sized industries and non-governmental organizations. Dr Ravi Dhar, senior consultant, Biotechnology Industry Research Assistance Program (BIRAP), Ministry of Science and Technology, explains the benefits of this Bill for start-ups. â€œStart-up companies are the intermediaries that convert a lab know-how into a feasible technology format that enable the large industrial companies to evaluate realistic risks and take an investment decision on adopting a particular technology. The Bayh-Dole Act provides incentives to the researchers, thus encouraging the formation of start-ups, which can fill in the gaps in the lab-to-the-plant journey, thus fueling innovation,â€? he says. The threat of stifling research The core purpose of a patent can be viewed as a method to add value to society through innovation and at the same time reward the inventor for his innovation. The current intellectual property system in the US has been a major source of inspiration for the one in India. However, the US system is viewed by many to be actually obstructive to innovation as it prevents others from building or improving on the idea behind the patent. Much like a double-edged sword, patent laws can be and are being bent to serve the purpose of earning revenue via litigation by the non-practicing entities (NPEs) rather than actually rewarding the innovation of an individual. NPEs or 'patent trolls', as they are popularly known, do not design or develop any intellectual property, nor do they earn any royalties from licensing them out. The lion's share of their revenue is via litigations and royalties from other companies, which use a part or whole of the patent owned by the NPE. This misuse of the patenting system is viewed by many to be a primary cause for stifling innovation in the US. A principal point to be considered is that this phenomena is being observed in developed countries after years of intense awareness of intellectual property issues and patenting, unlike our own country, which is still in the nascent stages of both. Dr Vijay Chandru, president, Association of Biotech Led Enterprises (ABLE) and CEO and chairman, Strand Life Sciences, echoes this thought. He says, â€œPatent trolls are receiving a lot of backlash in the US because the first to file is given the rights as compared to the first to successfully use the technology, an ideology with which most people don't agree with. However, in India, the awareness regarding these issues is rather minimal and hence there isn't any immediate threat.â€? The Parliamentary Standing Committee found that the Indian Bill is likely to take away creativity from universities and research institutions, and instead promote crass competitiveness. This is also echoed in other writings on the Indian Bill that say it erroneously assumes that protection of intellectual property is the best and only way to promote creativity and innovation. Professor Shiv Shankar, faculty member, material science department, nano-sciences engineering, chairman, IPR cell, IISc says, â€œThe Bill by itself will not be able to do much. The research institutes will have to conduct programs to increase awareness, which will then result in institutes adopting the measures stated in the Bill.â€? Dr Dhar seconds this opinion. â€œOne thing is sure that the implication of the Bill will require a bigger IP office and allied services in India, a need for robust data bases for managing timely registration and disposal of technology disclosure, and hence specially trained man-power to make it possible,â€? he says. One of the advantages of India being a late entrant in the enforcement of this piece of legislation is that we can observe the long-term effects that this law has had on the the practice of innovation in other countries. Patenting and licensing trends are not useful indicators of technology transfer success. The government is the most important entity in driving innovative ideas. Dr B N Ganguli, former assistant to the director, Hoechst Center for Basic Research, summarises it when he says, â€œThere is no yes and no answer to whether this Bill will foster innovative research. The government is the most important entity that would aid in driving innovative ideasâ€“possible in many ways.â€? Keeping these lessons in mind there is a need to mold the Bill according to India's requirements in order to fully benefit the people of India. Manasi Vaidya ]]> <![CDATA[Will it fast track research?]]> https://biospectrumindia.com/news/95/2917/will-it-fast-track-research.html https://biospectrumindia.com/news/95/2917/will-it-fast-track-research.html Mon, 14 Nov 2011 12:21:00 +0530 There are certain advantages to the Protection and Utilization of Public Funded Intellectual Property (PUPFIP) Bill. But will it fast track or stifle research with too much emphasis on intellectual property The government is believed to have introduced the Protection and Utilization of Public Funded Intellectual Property (PUPFIP) Bill with a view to promote innovation in research. The PUPFIP Bill would also lay down a framework for protection and utilization of intellectual property arising out of public funded research, the ultimate objective being public good. Although majority of experts agree that the PUPFIP Bill has certain advantages, which surely are expected to foster innovation in the academia, there are lot of disagreements too on the present form of the Bill. Advantages of the Bill Research institutions will, in a way, be obligated to protect and utilize intellectual property that is created by contribution of public funds if they want to retain title over the intellectual property (IP). These will focus on utility based research, which will, in turn, promote private collaboration with research institutions. Chances of utilization of products of public funded research will grow substantially due to the existence of an IP management committee, prescribed under the Indian Bill, to be established by every research institute that receives public funding. Inventors will be incentivized to pursue research because the Indian Bill prescribes that at least 30 percent of the royalty or profits generated from any public funded IP should go to researchers. The Indian people will certainly enjoy the fruits of public funded research since the Bill imposes heavy governmental regulations on assignment and exclusive licensing for using or selling products borrowed from public funded IP in India. As a result of the requirement to report to the government by the research institutions, the government will have a record of IP generated by public funded research as well as its value. Disputes are likely to decrease since the research institutions and the government are aware of their individual as well as inter se rights (the legal rights between or among the two parties that are involved). According to Mr KV Subramanium, president, Reliance Life Sciences, â€œOne of the important benefits of the Bill is that it provides greater clarity on title and ownership of IP where government funds are used. It also provides a legal framework for interface between the government agencies, academia and the industry. The new system is expected to improve the flow of innovation from the laboratory to the marketplace and also help institutions recover their research expenditures.â€? Terming it as a step in the right direction, Dr Vijay Chandru, chairman and CEO, Strand Life Sciences, and president, Association of Biotech Led Enterprises (ABLE), says, â€œThere is no doubt that there will be a push towards patenting resulting in filing of frivolous patents, but eventually the cost of patenting will dissuade people from getting frivolous patents.â€? Hopeful on the positive effects of the Bill, Dr Paul Ratnasamy, former director, National Chemical Laboratory, said, â€œI strongly support an Indian Bayh-Dole Act since it provides incentives for the innovators and patent inventors. The dismal performance of our academia (unlike that in the US, where the universities are major engines of technical innovation) in generating IPR and filing patents is to a significant extent, due to the total absence of incentives.â€? Dr Ratnasamy is currently at Conn Center for Renewable Energy Research, University of Louisville, Louisville, US. â€œThe Bill would hopefully provide for the protection and utilization of IP originating from public-funded research,â€? says Dr Ravi Dhar, senior consultant, IP Cell, BIRAP. He adds that it would, therefore, need modifications or revision of the existing IP rules and technology management strategy. Talking optimistically about the Bill, Professor Shiv Shankar, faculty member, material science department, nanosciences engineering, chairman, IPR cell, Indian Institute of Science, says, â€œThis Bill won't compel the scientists to go for patent protection, rather it will make it possible for institutes, which get government grants, to own the IP that they have generated. The DBT requires all the recepients of its grants to co-share the IP and gain 50 percent of the royalty. The DST has no set rules for the same.â€? Burning issues Some scholars and stakeholders point out that the legislation is unnecessary because the Indian government does not have a vast number of patents in its databases and that IP protection alone is not the best way to ensure technology transfer. The major disadvantages could be one or any of the following: The enormous penalties proposed to be imposed at every stage on the researcher as well as the research institutions under the Indian Bill may discourage research. The Bill seems to penalize the scientists who publicly disclose IP without a 30-day notice, and institutions that fail to protect IP, if it has a commercial potential. This could also lead the institutions to focus more on commercial research and ignore basic research, which may fuel innovations in the next 30-50 years. This Bill at the moment is being followed by many autonomous organization including the DBT. Copyright, trademark and others seem to be covered under the definition of 'public funded IP'. This might impair the basic research activity, which forms the basis of future industrial research. Requirement of compulsory protection of any intellectual property also gives rise to enormous amount of paperwork and may lead to administrative issues. Non-disclosure, which is a requirement in the Bill, restricts the dissemination of research within the academic community, and curtails freedom of openly discussing their research findings. Apart from this, since scientists cannot publish their research finding immediately, the findings get outdated, and promotional avenues for scientists get delayed. Exclusive licensing enables restrictions on the dissemination of academic research in the marketplace, and increase in cost of products based on public-funded research. Expressing serious doubts, Dr B V Ravi Kumar, managing director, Xcyton Diagnostics, says, â€œThis Bill will be detrimental for scientific research as it will put unnecessary pressure on research institutes to produce something which is patentable. Of late, the cost of patenting has shot up and and institutes which have a fixed budget for intellectual property issues will not be able to afford the costs of patenting. Most institutes actually cannot judge what intellectual property is useful and patentable and hence can run into losses if they try to obtain a patent for all their research.â€? Even Dr Vijay Chandru, who favors the Bill but has certain reservations, cautions, â€œSome points, such as the fine imposed if the research is not commercialized, are worrisome. There are some issues that need to be worked out. We need to be careful as it is not the first-to-file but rather the first-to-use who should be awarded the patent, an issue which is highly debated in the US.â€? â€œThe whole idea of a patent was to share the information so others can build and improve on the invention and reward people for the invention and essentially help build value for society. But when the same structure is used to block people from carrying out research, that's when society needs to worry. In India, if people go ahead and patent stuff, it's ok,â€? adds Dr Chandru. The Bill aims to incentivize innovation by sharing at least 30 percent of the royalty with scientists. Dr Ravi Dhar, senior consultant, IP Cell, BIRAP, said that despite the similar mechanism of sharing followed by numerous institutions for the last 20 years or so, the level of commercialization is very low. â€œMany of the autonomous institutes share a much higher percentage of royalty than the 30 percent mentioned in the Bill. The government needs to understand the reasons for low productivity, lacunae in the implementation and fair distribution of the royalty by stake holders, including the ones dealing with technology management,â€? says Dr Dhar. Rahul Koul in New Delhi ]]> <![CDATA[A balancing art between commercial, basic research required]]> https://biospectrumindia.com/news/95/1256/a-balancing-art-between-commercial-basic-research-required.html https://biospectrumindia.com/news/95/1256/a-balancing-art-between-commercial-basic-research-required.html Mon, 14 Nov 2011 12:17:00 +0530 Mr Rahul Dev, MS, MBA, LLB, patent & trademark attorney Mr Rahul Dev, managing partner at Tech Corp Legal LLP, has previously worked with Amarchand Mangaldas, one of the premier law firms of the country. His practice areas include pharmaceutical and biotechnology patents, litigation and business laws During the past few decades, intellectual property rights, including patents, trademarks, copyrights and industrial designs have gained an unprecedented economic importance in the global business arena. Out of all these rights, patent proves to be the most important and strategic business tool. Historically, it has been proven that successful research and commercialization of innovations is associated with a multi-fold increase in the number of patents granted and patent applications filed, specifically in the US, European Union, China and Japan among others. Furthermore, impressive business growth has been associated with royalty payments for patent licenses in these jurisdictions. One of the main reasons for this enormous business growth is the rapid progress of research in science and technology, especially in biotechnology, which resulted in the establishment of new knowledge-based industries and the penetration of new areas of technology, such as life sciences. In addition to this, the global economy has been greatly impacted by the establishment of the World Trade Organization (WTO) in 1994, with the new general agreement on tariffs and trade (GATT) and the international agreement on trade related aspects of intellectual property rights (TRIPS). While GATT resulted in gradual opening of international markets, TRIPS introduced, for the first time in the history of patents, mandatory international standards for the protection of intellectual property rights. More specifically, in accordance with the provisions of TRIPS, patents must be available in all WTO member countries for inventions in all fields of technology. The Indian perspective Although it is a proven fact that creation of new products and processes through technological research and the resulting innovations are very essential for a country's economic growth, India has not been able to excel as compared to other global counterparts. This is due to multiple reasons, such as, low level of technology commercialization, lack of industry funding for research, and an improper governmental mechanism for managing the ownership rights of intellectual property, developed in research institutions through public funds. However, as a significant step to improve this shortcoming in the Indian system, the Union Ministry of Science and Technology introduced the Protection and Utilization of Public Funded Intellectual Property (PUPFIP) Bill, 2008, in Rajya Sabha. Once this Bill is enacted, any recipient of government grants for the purpose of R&D, shall seek patent protection of the intellectual property generated and commercialize the same within the stipulated time. Primarily, this Bill has been aimed at boosting R&D in public funded research institutes by permitting the sharing of the intellectual property rights and providing the incentives to the institutes and scientists who created them. The Bill compulsorily requires the scientist, who creates an intellectual property, to immediately inform the research institution about the same, and subsequently, the corresponding research institution shall disclose this information to the government within 60 days. Furthermore, the scientist shall be paid a minimum of 30 percent of the net royalties received from the commercialized intellectual property, and any failure on the part of the scientist to intimate the institution, and of the institution to inform the government, carries penalties, which include fines and recovery of the grant funds. Role of law firms Since the proposed Bill is primarily meant to make a public funded research institution self sufficient by commercialization of its IPR, it presents a major challenge to various law firms that will advise such institutions. The challenge may include resolving multiple issues associated with the proposed law. The law firms will have to make sure that such research institutions are able to aptly balance their activities between areas of commercial research and in other areas which may not have commercial value. Moreover, since the Bill prevents scientists from public disclosure of any IP without a 30-day notice and further requires the research institution to protect IP if there is any commercial potential, the law firm will have to make sure that all these timelines are followed as any contravention may result in fines. At the same time, the law firm shall ensure that such time bound activities should create an enabling environment for commercialization and shall not suppress innovation and research. Furthermore, the Bill mandates that scientists shall retain a minimum of 30 percent royalty from commercialization of the IP. Such provision is included to incentivize creativity and innovation, and hence the law firms will be required to be equally careful in preparing technology and IPR licensing agreements. To sum up the role of law firms, it may be appropriately concluded that the objectives of their advisory should be focused on encouraging innovation in small and medium enterprises and on promoting a healthy collaboration between the public sector, private sector and non-governmental organizations. ]]> <![CDATA[Role of law firms after Utilisation of Public Funded Intellectual Property Bill 2008 becomes an Act]]> https://biospectrumindia.com/news/95/1238/role-of-law-firms-after-utilisation-of-public-funded-intellectual-property-bill-2008-becomes-an-act.html https://biospectrumindia.com/news/95/1238/role-of-law-firms-after-utilisation-of-public-funded-intellectual-property-bill-2008-becomes-an-act.html Mon, 14 Nov 2011 12:15:00 +0530 Ms Sunita K Sreedharan, lawyer, patent agent & CEO, SKS Law Associates, New Delhi An advocate and a registered patent agent, Ms Sunita K Shreedharan is a member of the Bar Council of India, LES and the AIPPI. She is member of Commercialization and Technology Management Committee (CTMC) of the Indian Council for Agricultural Research, Government of India. She was nominated for the â€œIP Woman of the Year 2008 Awardâ€? in Brussels in December 2008 and has articles published in the Journal of Intellectual Property Rights (JIPR), Managing IP, AsiaLaw, Lex Witness, Intellectual Asset Management. Her book An Introduction to Intellectual Asset Management was published by Wolters Kluwer. The Utilization of Public Funded Intellectual Property Bill 2008 provides a framework for the protection and utilization of intellectual property originating from public-funded research which would read as universities and research centers (referred to as public funded research labs). However, such a framework would amount to just that, a framework. For this proposed law to work, it would require the public funded research labs to recognize that its scientists are important members of the society at large and the scientists have a important role to perform as harbingers of scientific solutions to social problems. Since the scope of intellectual property under the new version of the proposed Bill has been limited to patents and plant varieties, the focus most obviously is on technology related research and development labs. It also means that the patent agent and patent lawyers become an integral part of the university research ecosystem. Both forms of intellectual property rely on being the first to file to be able to claim the exclusive rights under the respective IPR laws. In fact, I envisage that the role of the lawyers and law firms will become that of a guardian and legal mentor to the scientist viz a viz the implementation of the various provisions of the Utilization of Public Funded Intellectual Property Bill 2008 as and when it comes into law. The expertise profile of the legal practitioners involved in these matters would necessarily encompass subject matter expertise as in case of patent agents as well as expertise on technology transfer and contractual obligations. Situations such as exclusive license arrangements used by certain foreign organizations to commandeer intellectual property generated in the Indian universities and research centers will have to be closely monitored by lawyers with considerable experience in understanding the technology landscape as well as various forms of efficient and effective transactions under the prevailing contract law and the IP laws. In effect the profile of the lawyer will have to necessarily change from being either a patent attorney or a transaction lawyer to a balanced amalgam of both with enough exposure to the licensing market as well as the litigation scene. Personally I would say that while a patent lawyer is the required profile, the said lawyer must also have enough exposure to identifying trade secrets, handling of confidential information as well as trademark, copyright and industrial design laws to be able to spot golden opportunities and ensure competitive advantage of the university technology viz a viz their competitors. An ideal situation would be the establishment of a technology transfer office with suitable representations of a transactional lawyer, a patent agent and a business development officer. I call it the 3-pronged approach. This will help in establishing: an in-house system of submission of a research outcome an evaluation system for patentability a system for conducting novelty searches, drafting, filing and monitoring of the patent portfolio a cell for searching out licensing partners for development work from lab to market, conducting clinical trials or field experiments, entering foreign markets including filing corresponding patent applications overseas and / or creation of patent pools for platform technologies an overarching innovation ecosystem including a network of other national and international research laboratories of course, business development with aid from the research scientists / scholars themselves While some of the IITs and research organizations in India do have an incipient technology transfer office, the focus is merely on patent filing and prosecution with no clear concepts of licensing mechanisms and prevention of appropriation of intellectual property through devious agreements with third parties. Interestingly, many of these public funded research labs do not ever commission a technology landscape or such studies to take a proactive decision on the line of patentable research that can be undertaken for finding solutions to a given problem. It is also a fact that there is a rather self-defeating trend of intellectual arrogance among the university Fellows which include both the professors as well as research scientists, which in today's world of innovation is rather a ridiculous stance to adopt. Today, the norm is the application of a business mind to convert both the successes as well as the apparent laboratory failures into a startling business ventures through sound legal transactions and sharp business mind as well as effective legal interventions by way of enforcement and / or non-exclusive licensing strategies. It may well be that the proposed law could be the tool for the systematic and consistent development and channelizing of the Indian scientific temper into creating viable solutions to socio-economic problems. But this can happen only if the public funded research labs bridge the gap between the innovators, their lawyers and the business developers and establish an efficient and well-organised in-house technology management and transfer offices having efficient legal help in terms of patent agents, transaction lawyers and business development officer, who can if need be handle work in-house, but are proficient enough to seek outside legal help as and when the situation warrants before serious damage is done to the technology so painstakingly developed by the public funded research labs. ]]> <![CDATA[A promising venture or a flawed legal transplant?]]> https://biospectrumindia.com/news/95/2603/a-promising-venture-or-a-flawed-legal-transplant.html https://biospectrumindia.com/news/95/2603/a-promising-venture-or-a-flawed-legal-transplant.html Mon, 14 Nov 2011 12:12:00 +0530 Mr Shouvik Kr Guha The author has completed BA LLB (Hons) from West Bengal National University of Juridical Sciences, Kolkata, and is currently working as a research associate In January 2009, the Indian government introduced in Rajya Sabha the Protection and Utilization of Public Funded Intellectual Property (PUPFIP) Bill, which heavily draws inspiration from the US Bayh-Dole Act. It has been faced with considerable criticism due to the lack of transparency surrounding the drafting of the Bill as well as at several provisions thereof. It has since then undergone scrutiny by a Parliamentary Standing Committee, which has prescribed certain amendments before it can be made into an act. Much like its US parent, the Indian Bill vests institutes with the right to acquire patents over inventions derived from publicly-funded R&D. However, instead of a facilitative framework encouraging patent applications, it imposes a harsh punitive framework mandating institutional patenting under threat of serious sanctions. Moreover, the Bill's purview extends beyond patents, covering other forms of intellectual property (IP), such as copyright, plant varieties, semiconductor layout, and trademark. While as a former British colony, India is more than familiar with western legal transplants, this current effort can unfortunately be perceived as even more flawed than the original, thereby being likely to face rejection by a host of legal regime and perhaps rightly so. Apart from exhibiting a lack of prudence in its blind efforts at transplantation, the earlier versions of the Bill have also so far reflected a complete lack of understanding of ground-level realities of publicly-funded research in India the modes of appropriation and dissemination of results of such research and the industry nexus. Opinions are divided even on the original US Act's usefulness in the promotion of innovation and patent application by publicly funded universities and other organizations. At best, it provides a skeletal model for adoption by countries to construct an optimal regulatory regime. Among the usefulness that a similar piece of legislation, like the Indian Bill, can bring is the possibility of regulating hitherto uncontrolled patenting of public-funded research. The scenario of patent titles in India is already murky due to the Patents Act, 1970, the General Financial Rules and specific employment agreements. The situation is likely to be roiled further by the Bill, given that the latter covers grant situations, but not necessarily sponsorship grants. Although the Indian Bill draws its inspiration from the US Bayh-Dole Act, it fails to appreciate the latter's facilitative nature and opts instead for a punitive framework, in which institutions are effectively forced to register almost every piece of intellectual property that is created, under the threat of serious sanction. Due to this, it is a flawed legal transplant. However, this is not to say that the primary objectives of the Bill, including wealth creation, promoting technology transfer, accountability of public-funded institutions and innovation-culture as well as providing higher royalty-shares to the scientist-inventors, are not laudable in themselves. It is just that the government must retain a set of realistic expectations from the Bill and not go overboard. Wealth creation by the Bayh-Dole model has faced its due share of flak even in the US and available statistics about the commercial viability of the patenting efforts of Indian institutes like the Council of Scientific and Industrial Research augur, ill for the same. Similarly, rigorous record-keeping, accounting obligations, and audits appear to be much better means of ensuring accountability than forcing public-funded institutions to patent any and all inventions that they generate. Moreover, while technology transfer is a commendable objective, the Bill in its current form is overly broad, forcing institutes to patent any and all inventions without providing any specific framework or incentives to promote technology or knowledge transfer. Based on overtly romanticized conceptions of the Bayh-Dole Act, it also makes a flawed assumption that patents are always the best way to incentivize innovation and transfer technology and requires patent application in all cases, leading to potential waste of resources. The inability of converting patented inventions into socially useful products has thus been overlooked. Providing 30 percent mandatory royalty to the scientist-inventor is perhaps one of the rare provisions of the Bill to have received uniform approval, although the Bill forces the publicly-funded inventor to patent his invention even if he wants to put it in public domain. Given that the Indian effort was nothing more than a formalistic importation of the US Bayh-Dole Act with a few cosmetic changes and some harsh punitive provisions thrown in at the last minute, the imperfect outcome is unsurprising. The lawmaking process, which the Bill passed through reflects a lack of transparency as well as a lack of study and consultation with critical stakeholders, whom the Bill is likely to impact the most. Fortunately, the standing committee has asked the government to reconsider certain provisions of the Bill after more meaningful consultation with stakeholders. It was to this end that a few proposals have been made by scholars and stakeholders to improve upon the current structure of the Bill. These include achieving wider 'knowledge spillovers' and evaluating performance of scientists and institutions, open-access publishing, encouraging socially relevant innovation, creation of nodal authority for administrative purposes, facilitating non-commercial governmental use of such inventions and fostering greater transparency. It also includes, incorporating more public interest safeguards like mandating affordable pricing of all products deriving from publicly-funded patents, making licensing of such patents compulsory in appropriate cases, favoring SMEs and local manufacturing, and vesting more discretion in the individual inventor to determine how to disseminate his invention, to name a few. Until and unless the aforesaid flaws are addressed and at least some of the suggestions mentioned above are incorporated in the Bill, it is most likely to remain an exercise in futility and a prominent example of flawed legal transplantation at best. ]]> <![CDATA[Industry-academia tie-ups to foster innovation]]> https://biospectrumindia.com/news/95/4366/industry-academia-tie-ups-to-foster-innovation.html https://biospectrumindia.com/news/95/4366/industry-academia-tie-ups-to-foster-innovation.html Mon, 14 Nov 2011 12:05:00 +0530 Collaborations between the industry and the academia are vital for the success of this Bill and without the provisions to patent intellectual property, the industry will not feel the need to commercialize inventions In countries such as the US and Europe, innovation traditionally has had its genesis within the confines of universities and academic institutions. In the case of biotech research too, innovative molecules are discovered within the labs of academic institutions up to phase II before being licensed to big pharma and biotech companies, which have the capabilities to develop and commercialize the product. This, coupled with a decent amount of funding or grants and other forms of support from the government and public agencies, makes it a win-win situation for both the academia and the industry. The strong nexus between the industry and academia has not just taken many products from the lab to the market but also encouraged scientists to engage in more research studies. In the 1980s, the US Bayh-Dole Act played a significat role as a catalyst to inculcate the practise of technology transfer between universities and the industry. This culture is lacking in India due to myriad reasons, such as lack of funding, lack of incentives for scientists, a disconnect and strong divide in the perspectives of the industry and the academia. A collaboration between the two is a prerequisite in bolstering research on new chemical entities (NCEs) and new biological entities (NBEs) in the country. The Protection and Utilization of the Public Funded Intellectual Property (PUPFIP) Bill, 2008, or the Indian version of the Bayh-Dole Act, seeks to sow the seeds of this culture by fostering innovation and protection of intellectual property by incentivizing research. However, can a theory be translated into practice if the Bill becomes a law? Will India be able to replicate a scenario that took place 30-years-ago in the US? Collaborations are vital Collaborations between the industry and the academia are vital for the success of this Bill. Giving an academic perspective, Dr B N Ganguli, research adviser to the KJ Somaiya Group of Colleges at Vidyavihar and former deputy to the director of Hoechst Center for Basic Research, says, â€œThe industry-academia interaction must be reviewed in depth in the Indian context. Today, there is a barrier in mutual trust that must be dissolved. The academia believes that the industry is only interested in quick profit research and not advancement of scientific innovations. The government can and must play a significant role in the academia-industry cooperation and collaboration.â€? The Bill has been modeled on a formula that more intellectual property is equivalent to more innovation. It was structured on the premises that conferring ownership and patent rights to universities will accelerate collaboration between the two segments. Without this provision, the industry will not feel the need to commercialize inventions out of the academia. Mr KV Subramaniam, president, Reliance Life Sciences, says, â€œThe Bill should bring about better academia-industry collaboration, as commercialization of IP should be a big driver.â€? Dr Milind Antani, head of pharma and life science practice, Nishith Desai Associates, says â€œOur opinion on this question is heavily coloured by the view of the secretary, Department of Biotechnology, Ministry of Science and Technology. According to him, the flow of knowledge from laboratory to industry is happening but it is not happening effectively and uniformly in all the public funded academic research institutions because this requires process development.â€? He adds that the Bill aims to institutionalize the processes by bringing a uniform understanding and practice of mapping intellectual property, patenting and technology transfer, so that the flow of knowledge to the industry is seamless and efficient. â€œBorrowing information on status quo from the secretary's statement above, the Bill does have the potential to bring about industry-academia collaboration in the country. The mandatory requirement of protection of intellectual property and obligation to utilize it would increase the flow of knowledge from research institutions to the industry and lead to technology transfers,â€? says Dr Antani. Dr Vijay Chandru, president, Association of Biotechnology Led Enterprises (ABLE) and chairman and CEO, Strand Life Sciences, says that the Bill may put India on the right track. â€œIn the Indian context, we can mimic the US act but the other pieces of the ecosystem, such as a tech transfer office and incubation centers, have to be taken into account. The major research institutes are starting to work in that direction. The Department of Science and Technology, always had a process through which you could approach them for commercialization of an invention, but it was a case-by-case scenario. In the broad sense, it is a step in the right direction. Some points such as the fine imposed on research that is not commercialized are worrisome. There are some kinks that need to be worked out.â€? The concerns The main concern amongst industry and academia circles is whether or not extra emphasis on IP protection and high costs of patenting would stifle research and innovation. This Bill if translated into an act will be detrimental for scientific research as it will put unecessary pressure on research institutes to produce something which is patentable, claim some experts. Says Dr BV Ravi Kumar, managing director, Xcyton Diagnostics, â€œThe cost of patenting has increased and institutes that have a fixed budget for intellectual property issues will not be able to afford the costs of patenting. Most institutes actually cannot judge what intellectual property is useful and patentable and hence can run into losses if they try to obtain a patent for all their research. This Bill is based on a misconceived notion. There should be laws which are enabling instead and create higher awareness and sufficiently protect a conceived product.â€? The industry requires the products developed by research institutions to be viable as product development is costly. Merely having a patent does not translate into licensable products. Dr Kumar also points out the need for bodies that can act as junction points between industry and academia. Strong collaborations can be formed when the industry representatives are allowed to work alongside academia and are incubated in the institute for the initial stages of product development. With regards to high cost of patents, Dr Chandru gives another perspective. â€œThere is no doubt that there will be a push towards patenting resulting in filing of frivolous patents, but eventually the cost of patenting will dissuade people from getting frivolous patents,â€? he says. At the end of the day, claim experts, ownership of patents should lead to acceleration of innovation and not block research that could benefit the society at large. ------------------------------------------------------------------------- 'Bill is planning to cover every type of IP entity' Interview with Mr Abhay Porwal, head of operations, IPpro Services India Private Ltd, Bengaluru Mr Abhay Porwal's specialties include patent drafting (in accordance with US patent and trademark office guidelines), patent filing, patentability assessments, patent invalidation and infringement searches, freedom-to-operate searches, claims mapping projects, technology and intellectual property (IP) landscaping analysis, freedom-to-practice analysis and product clearance search. He is an alumni of the Indian Institute of Technology, Mumbai, and previously worked as an IP analyst at Honeywell Technology Solutions Lab, India. Do you think India needs a Bayh-Dole Act, given the present rate at which scientists are getting patents on their inventions? Mr Porwal: The Protection and Utilization of Public Funded Intellectual property (PUPFIP) Bill is aimed at protecting each and every invention that is coming out of government funded research. There are several institutions and inventors with various sources of funding such as industry collaborations. This enables them to carry out research, protect the IP in it and finally commercialize it for generating revenue for themselves and the industry partner. However, there are institutions that may not be able to collaborate well with any industry partners. In such cases, the government funds (with the requirement of patent protection as per the Bill) might help the universities and the inventors to carry out research and encourage innovations. This may foster a research culture in the institutions and we might see many great technologies coming out of our own institutions. Having said that, there are chances that the commercializing aspect may hijack the research culture at the universities. Researchers may very well focus only on research areas that have great commercializing potential. This may adversely affect fundamental research, which takes many years to reach the market. Another point with government-funded research is that there is a possibility that inventors may not get enough in royalties. In the case of acquisition of any patent by the government (these can be government-funded research as well), the patentee will also be given a reasonable remuneration. However, reasonable remuneration is vague and may not be a substantial amount, so inventors are less incentivized. The Bayh-Dole Act clearly enables inventors to get a reasonable share of the royalty. Do you think it will be possible for research institutions to afford the legal costs associated with patenting? Mr Porwal: Since these are government-funded research, the technology transfer office of the institute may have to budget for the patent cost. The cost for applying a patent in India is nominal and thus should be affordable. However, institutions can think of identifying possible licensee and get them to cover the patenting cost (reimbursing the cost if already spent by the institution). If the patent application is still pending, then while licensing the patent application, the licensee needs to cover the legal cost as well or a portion of the legal cost. The legal cost may include prosecuting and paying the maintenance fee. If any future improvements are likely to come out of the pending application, then payment for filing and prosecuting of the patents for these improvements can be covered by the licensee. Are there any other channels of protecting intellectual property that can and should be incorporated in the Bill? Mr Porwal: As far as protection is concerned, the Bill is planning to cover each and every type of IP entity for protecting the inventions. Would scientists be compelled to get patents on their research following the passage of this Bill? Mr Porwal: The PUPFIP Bill, in its current form, gives rights to a government funded institution for it to decide whether or not to opt for patent protection for inventions that are coming out of research, which is funded by the government. Therefore, in scenarios when there are differences between the institution and the inventors regarding the need for a patent protection, the final decision lies with the institution. Thus, technically the inventors might be forced to seek patent protections for their inventions in case the institution they work for want the same. Do you think universities will be able to earn a sizable amount through licensing incomes? Mr Porwal: This would depend on the actual inventions coming out the universities. As is the case with any other breakthrough invention, if a discovery is directed towards an area requiring immediate attention and has potential of making it big in the market, you surely would have many takers for it and, in turn, the licensing deals will pour in. - Manasi Vaidya ]]> <![CDATA[A Bill full of promises]]> https://biospectrumindia.com/news/95/5961/a-bill-full-of-promises.html https://biospectrumindia.com/news/95/5961/a-bill-full-of-promises.html Mon, 14 Nov 2011 12:03:00 +0530 The PUPFIP Bill, inspired by the Bayh-Dole Act of the US, proposes to take research being done at universities up to the commercialization stage. However, how much of the impact would play out would depend on the ecosystem for innovation encompassing academics, national research labs, private research labs, capital and talent availability The Protection and Utilization of Public Funded Intellectual Property (PUPFIP) Bill, 2008, commonly known as the proposal for an Indian Bayh-Dole Act, was first tabled in 2008 in Rajya Sabha. Tabled by the then minister of science and technology, Mr Kapil Sibal, the draft was an emulation of the the US Bayh-Dole Act of the 1980s, modelled on the premise that protection and utilization of intellectual property coming out of state-funded research institutions and universities would harness the wheels of innovation in India and see its fruits in the market. The biotechnology industry in India at that time recorded a total sales revenue of $2.57 billion (10,273 crore) recording a 20 percent growth, and it was hailed as the next big thing for science. It was assumed that like its US counterpart, the biotech industry too would open the floodgates of innovative research, ensure greater interaction between the industry and the academia, incentivize scientists, and above all, bolster growth of the biotechnology industry in India. On paper, it was hailed by all as a progressive piece of legislation. The Bill The Protection and Utilization of Public Funded Intellectual Property Bill, 2008, states that its aim is â€œto provide incentives to increase innovations, collaborations, licensing and commercialization in Indiaâ€?. The Bill is an attempt to take research being done at universities up to the commercialization stage, which are otherwise restricted to academic journals and peer reviewed papers. It throws light on aspects such as funding, disclosure of public funded intellectual property, vesting of title of public-funded intellectual property, assignment of intellectual property, duties of intellectual property creator, constitution of intellectual property management committee and its functions, sharing of royalties or income, protection of action taken in good faith, stoppage of grant and recovery of grant released and penalties for failure to discharge duties of intellectual property creator. With respect to funding, section 3 of the Bill mentions that any recipient interested in taking a grant from the government for the purpose of R&D shall enter into an agreement with the government before the receipt of such a grant. The recipient shall make disclosure of public funded intellectual property to the government within the time specified under section 4. A recipient here is a university or an institution of higher education established for research purposes that has entered into an agreement with the government and any organization established by an act of Parliament or a non-profit scientific or educational organization registered under the Societies Registration Act, 1860. With respect to disclosure of public funded intellectual property, section 4 of the Bill stipulates that the recipient shall, within a period of 60 days of actual knowledge of the public funded intellectual property, make a disclosure to the government. If the grantee institution wishes to patent the said invention, it must make a declaration to the government agency within a period of 180 days of the disclosure under section 4. If the recipient fails to disclose the public funded intellectual property under section 4 or give such intimation within the specified time, the title of the public funded intellectual property, shall vest in the government. Every recipient shall within 180 days of the receipt of the funds under section 3, constitute an intellectual property management committee within its organization. In terms of royalties and income, section 11 of the draft mentions that royalties or income received by the recipients from the intellectual property shall be shared with the inventor in a proportion of 30 percent of net expenses on IP protection and utilization. The Bayh-Dole Act & its Indian version The PUPFIP Bill is inspired by the US Bayh-Dole Act of 1980s that allows research institutes and universities' ownership of patents on their inventions that are federally funded. The Bill in the US was tabled in the senate as an amendment to the Patent and Trademark Act by Senators Birch Bayh of Indiana and Bob Dole of Kansas. Cascade effects of the law on the US biotechnology industry was huge. It was a spark that accelerated technology transfer between universities and industry. By incentivising inventions and research, the country saw scientists turning towards entrepreneurship and setting up spin-off companies to translate academic research into commercialized marketable products. Dr Vijay Chandru, chairman and CEO, Strand Life Sciences, and president, Association of Biotechnology Led Enterprises (ABLE), says, â€œIn the US, this act gave the rights for commercializing the output available to the inventors and research institutes. By the early 1980s, institutes such as Stanford and MIT did not need a Bayh-Dole Act as there was already a lot of translational research.The law was actually helpful for state universities, as it gave them a structure for being able to translate research.â€? Ms Khushboo Baxi, senior member, pharma and IP team, Nishith Desai Associates, says, â€œThe Indian Bill provides for greater IP protection to products of public funded research. The most significant difference between the two is that the Indian Bill seeks to protect intellectual property in different forms, such as trademark, copyright and patent, whereas the US Act provides only patent protection to subject inventions. The two have similar objectives, but the US Act covers far more territory than the Indian Bill.â€? Experts from the industry are hopeful that if channelized in the right direction, this Bill can have a similar impact on the biotechnology industry in India as the Bayh-Dole Act had in the US. Mr KV Subramaniam, president, Reliance Life Sciences, says, â€œThe Indian Bill is, by and large, similar to the US Bayh-Dole Act. Going by the stated objective, it should have a positive impact on the innovation scenario in India. How much of this impact would play out would depend on the ecosystem for innovation encompassing academics, national research labs, private research labs, capital and talent availability.â€? COMPARATATIVE OVERVIEWS PUPFIP Bill 2008 (India) Bayh-Dole Act 1982 (US) 1. The Bill seeks to provide incentives for creating and commercializing intellectual property from public funded research. 1. The act enables non-profitable organizations, including universities, and small businesses to retain title to innovations developed under federally-funded research programs. 2. The Bill requires the scientist who creates an intellectual property to immediately inform the research institution. The institution shall disclose this information to the government within 60 days. 2. Universities are encouraged to collaborate with commercial concerns to promote the utilization of inventions arising from federal funding. 3. The institution is required to inform the government of the countries in which it proposes to retain the title to the PFIP. The title in all other countries will vest in the government. 3. Universities are expected to file patents on inventions they elect to own. 4. The scientist shall be paid a minimum of 30 percent of net royalties received from the PFIP. 4. Universities are expected to give licensing preference to small businesses. 5. Failure of the scientist to intimate the institution, and of the institution to inform the government carries penalties, which include fines and recovery of grant funds 5. The government retains a non-exclusive license to practice the patent throughout the world. (Contributed by Dr Ravi Dhar, senior consultant, IP Cell, BIRAP, Department of Biotechnology and former head-IPR, NII, New Delhi.) Nayantara Som, Rahul Koul and Manasi Vaidya ]]> <![CDATA[FDI in Pharma: Does India require a policy revamp?]]> https://biospectrumindia.com/news/95/1164/fdi-in-pharma-does-india-require-a-policy-revamp.html https://biospectrumindia.com/news/95/1164/fdi-in-pharma-does-india-require-a-policy-revamp.html Mon, 14 Nov 2011 12:01:00 +0530 There is a raging question on controlling foreign direct investment in India amidst worries that acquisitions of Indian pharma and biotech companies by foreign firms will make access to healthcare difficult BioSpectrum tries to find some answers In the backdrop of foreign multinational companies (MNCs) taking over some major Indian pharma and biotech companies, there have been increased concerns over its effect on the price of generic drugs. The Department Of Industrial Policy And Promotion (DIPP) that oversees the policy framework allowing or restricting foreign direct investment (FDI) in the country, under the Ministry Of Commerce And Industries, in July 2011, came out with a discussion paper inviting views on the rationale and relevance of putting a cap on FDI. Following this, the Department pushed for restrictions on foreign investments in the pharma sector. Since 2006, as many as six big Indian pharma companies have been taken over by foreign firms. About $4.73 billion or 50 percent of the recorded FDI in the sector since the year 2000 has been in the form of mergers and acquisitions. In the year 2006, Matrix Lab was sold to the US-based company Mylan. In 2008, Dabur Pharma was bought by Singapore-based Fresenius Kabi. Again in the same year, Ranbaxy was taken over by the Japanese company, Diachii Sankyo. The year 2009 witnessed two major deals in which Shantha Biotech was taken over by the French major Sanofi Aventis and the US-based company Hospira took over Orchid Chemicals. The latest example is of Piramal Healthcare, which was bought in the year 2010 by the US multinational, Abbot Laboratories. Earlier this year, the government set up a panel headed by Planning Commission member Mr Arun Maira to study a proposal to reduce FDI in the pharma sector from 100 percent to 49 percent and check whether it requires a policy intervention. Currently, there is 100 percent FDI in pharma under automatic route and the foreign companies only have to inform the Reserve Bank of India at the time of investing in India. They are allowed to invest 100 percent in India without the prior approval of the Foreign Investment Promotion Board (FIPB) . Few critics argue that the government should utilize its agencies, such as Competition Commission of India (CCI) and National Pharmaceutical Pricing Authority (NPPA) efficiently to ensure the fair use of foreign investments instead of blindly limiting the investment. Divergent viewpoints There seems to be a difference of opinion among the sections of the industry regarding this issue. The associations representing Indian and foreign drugs manufacturers also seem to be at loggerheads. Those against any strong measure by the government point towards the fact that a dual policy cannot be followed when Indian companies can go abroad and acquire 100 percent stake in a company. According to them, attention must be paid to have enough regulations, such as compulsory licensing, that protect Indian firms. The local drug industry fears that continuation of the 100 percent automatic approval policy will be perceived by foreign investors as the government's endorsement of takeovers by them. The apprehension prevalent within the domestic industry is that MNCs would soon come to monopolize the pharma sector in the country. The smaller companies competing with multinationals are against total monopoly and complete foreign ownership. They have recieved support from the Health Ministry that fears losing control over drug prices. However, most of the industry leaders say that such a move would be detrimental to the country's image as an investment destination. â€œWe strongly believe that this move will be a retrograde step in the financial reforms process of the country and would adversely affect the foreign investment not only in the pharmaceutical sector in India but possibly, far beyond it,â€? the Organization of Pharmaceutical Producers of India (OPPI), which represents foreign drug makers in India, said in a note submitted to the Ministry in August 2011. â€œPolicy decisions should always be based on facts and not on apprehensions,â€? says Tapan Ray, director general of OPPI, which is also an affiliate of the International Federation of Pharmaceutical Manufacturers and Associations. Speaking on the sidelines at the second annual meeting of BIO India International, Kiran Mazumdar Shaw, CMD, Biocon, said, â€œThis is a growing sector and attracts investment. Any measure to restrict FDI flow will be a regressive step and will devalue this sector.â€? Dr Rajeev Soni, CEO, Premas Biotech, which has 100 percent FDI and is not allowed to use government grant, says, â€œAlthough it is important to safegaurd the interests of the domestic industry, I don't think the reduction in FDI will help. Moreover, though FDI is allowed in India, there are certain caps. For example, the companies that have 100 percent FDI are not allowed to have PPPs for government-funded projects. â€œOn the one hand, the government enourages FDI and on the other it penalizes the companies by not allowing them to avail government grants. In my opinion, if the company is working on an innovative project of national importance, its case needs to be looked at differently. The blanket rules that discourage the entreprenuers in the industry need to be removed and handled on case-to- case basis,â€? adds Dr Soni. Mr Andrew Witty, CEO of GlaxoSmithKline, voicing his opinion on the issue of foreign ownership of Indian domestic companies, says, â€œDon't see ghosts where they aren't any.â€? Mr Kamal Karanth, MD, Kelly Services, believes that Indian patients have benefitted from the latest discoveries faster by the presence of R&D-focused companies in India. â€œWe can't afford to lose this access. In fact, we need innovative pharma companies to invest further in India to focus on diseases unique to India. Foreign MNCs have always been present in India. Pharma acquisitions are not new for India and there aren't too many instances of irrational price rise,'' says Mr Karanth. No reduction in FDI The Maira Committee Report, submitted in early October 2011, recommended that in order to enhance scrutiny of pharma mergers and acquisitions, merger control thresholds should be lowered and the Competition Commission should be equipped better. The Commitee did not propose any change in the 100 percent automatic FDI policy. However, since the Health Ministry wanted more protection, the Cabinet on October 11, 2011, took a decision that 100 percent automatic FDI in Greenfield investments will continue but FDI in Brownfield investments would go through the FIPB clearance at least for the next six months. After that the requisite oversight will be done by the CCI entirely, in accordance with the Competition laws of the country. Reacting to the same, Mr Sujay Shetty, leader, Pharma Life Sciences, Price waterhouse Coopers states, â€œSome of the things that the FIPB may take cognizance of is the points raised by the Ministry of Health and that is whether enough jobs will be created, will there be more R&D, will manufacturing capacity go up, and assurances that supply will be continued, prices will not be raised, product portfolios would be such that they would not skew towards more expensive portfolios, that they will abide by law in the country, some of which could be around compulsory licensing.â€? With this decision, it seems that the question over the reduction of cap from 100 percent to 49 percent is settled for now. Rahul Koul in New Delhi ]]> <![CDATA[BT firms meet their first deadline for mandatory barcoding]]> https://biospectrumindia.com/news/95/2243/bt-firms-meet-their-first-deadline-for-mandatory-barcoding.html https://biospectrumindia.com/news/95/2243/bt-firms-meet-their-first-deadline-for-mandatory-barcoding.html Mon, 14 Nov 2011 11:58:00 +0530 DGFT's second notification has been viewed by companies as detailed and the deadline as feasible since it mandates implementation of the track and trace system in a phased manner in the country Despite fierce opposition from the industry, a couple of months earlier, the Director General of Foreign Trade (DGFT) was determined to stick to its initial notification on mandatory barcoding. In order to allay apprehensions of the industry, it decided to extend the deadline for implementation of the track and trace system. As per its notification, dated June 30, 2011, the DGFT amended its Public Notice No 21, issued on January 10, 2011, by mentioning, 'Exporters of pharmaceutical products will adopt a trace and track system and incorporate its features for exported medicines using barcode technology as per GS 1 global standards'. This includes packaging at the primary, secondary and tertiary levels. However, unlike its previous notification, the track and trace system, this time it will be introduced in a phased manner across the country. The deadline for incorporation of track and trace systems is October 1, 2011 for primary packaging, January 1, 2012 for secondary level packaging, and October 1, 2012 for tertiary level packaging. The DGFT made this move after $2.16 million worth of counterfeit anti-malarial drugs bearing 'Made in India' labels were seized by the Nigerian authorities in 2009. Subsequent to this incident, drugs exported specifically out of India, were assumed to be counterfeit drugs and were put under the scanner by port authorities across Africa and Europe. In order to put in place a system of checks and balances for counterfeit drugs, the DGFT issued a notification in January 2011, making it mandatory for all pharmaceutical and biotech companies to affix barcodes on their export products to track and trace their stock across the entire supply chain by July 2011. The move was met with a barrage of criticism by the industry. It complained that compulsory barcoding would lead to high rise in costs, was unfeasible for implementation by medium and small size companies and above all, it will send wrong signals (on India being the hub for counterfeit drugs) to the global community. Accordingly, the Union Ministry of Commerce amended the notification by putting an extension to the said deadline. A clear and detailed notification DGFT's amended mandate to implement track and trace systems in a phased manner rather than in one go, has been viewed by a majority of industry observers as a prudent move. It drastically eases down the pressure to set up capital-intensive infrastructure systems in a limited time span. Says Dr Praful Naik, CSO, Bilcare Research, â€œThe practice of implementing it in a phased manner will ease the pressure for many companies. In the previous notification, barcoding of export drug consignments had to be done all at once for all levels of packaging, which made it a complex process.â€? While multinational companies had already been following serialization processes prior to the first notification, a couple of Indian companies have also put in their infrastructure in place in order to meet the deadline, including firms like Glenmark, Cipla and vaccine companies like Serum Institute of India and Haffkine Biopharmaceuticals. Says Ashok Saxena, head, technical operations, Glenmark Pharma, â€œWe have adhered to the deadlines given by the Government (in this case October 1, 2011). I feel that it would be difficult for small companies, but they would gradually adapt this practice.â€? Another change in the second notification is the mention of the fact that the Government would establish a central portal for tracking and tracing exported products. The portal would be a central server, which would contain all the data and details of manufacturers in the country. This data can be accessed by any importing country. An exporter can upload information onto this central portal rather than investing a huge amount of funds in setting up a separate server. â€œThe central portal which is to be set up by the Ministry of Commerce, is a huge leap and would save costs for a number of small and mid-size companies, for whom setting up separate servers for data management would be a problem,â€? adds Dr Naik. The second notification, according to many experts, is more detailed and systematic. While it calls for setting up of a track and trace system, at the same time it also calls for authentication systems which would also check the authenticity of a product. A barcoding system might identify the product but it might not be successful in checking its authenticity. The notification mentions that, 'authentication features will be added in due course and integrated with the trace and track system.' Biotech companies gear up Like its pharmaceutical counterpart, the biotechnology industry in India to a large extent derives its business revenues from exports. According to the 2010-11 BioSpectrum-ABLE annual survey for the biotechnology industry in India, the sector clocked revenue worth `17,249.34 crore in FY 2010-11, out of which exports made up 51 percent of the overall revenue contributing a total of `8,852.34 crore. Biopharmaceutical exports contributed `5535.4 crore over last year's exports of `4767.66 crore. Post DGFT's mandate, biotechnology companies, while maintaining that they did not have a choice but to implement the practice (without which their consignments could not move forward), have at the same time opined that the timeline given to them, this time, has been feasible. A majority of Indian vaccine companies, in particular, have already met their deadlines. An official from the vaccine major, Serum Institute of India (SII), Pune, says, â€œWe have already implemented the system. Being a major vaccine producer, we use sophisticated methods and systems and lot of our products are exported which does require barcoding. Investment has never been an issue for us. I feel the deadline is good enough for us and the government has given us a lot of time to put the systems in place.â€? SII's products are supplied to international health agencies like the World Health Organization (WHO), United Nations Children's Fund (UNICEF), Pan American Health Organization (PAHO) and also to more than 140 countries across the globe. Its vaccines are being used in the national immunization programs of several countries. SII supplied its HIB vaccine to the Global Alliance for Vaccines and Immunization (GAVI), PAHO and UNICEF. Mumbai-based Haffkine Bio-Pharmaceutical, a public enterprise engaged in the manufacture and supply of a wide range of biological and non-biological products comprising bacterial and viral vaccines, supplies its vaccines to bodies like the UNICEF. Officials from the company told BioSpectrum, that while they have met the requisite deadline, the company is taking additional steps to ensure that the practice is fully followed. Says an official from the company, â€œWe even send our officials for training on barcoding implementation since we are particular on quality in manufacturing.â€? The hitch however is that it is unclear where to position the barcoding label on the vaccine vial. â€œThe polio vial for our vaccines is heat sensitive and very small. We are still unclear on the place where the label is to be positioned,â€? adds the same official. For a section of biotech companies, it is still not clear whether the notification is applicable even to biotech APIs alike. Says an official from Concord Biotech, â€œWe are still not sure whether this mandate is applicable just to formulations or to API companies like us.â€? The cost of implementing such a system has been the bone of contention between the Government and the industry since the mandate was first passed in January 2011. The cost for one 2D label is around a dollar. High-end printers and scanners lead to additional costs. Industry experts opine that smart and intelligent costing models will come to the biotech sector's rescue. An outsourcing model would hence fit the Bill. Moreover, biotech companies also opined that the government's central portal system would save them the cost of setting up separate servers. â€œI feel if and when this system comes into place, business in the country would grow multifold. An importing country would rather look at India than a developed nation. However, the challenge remains that many Indian companies still do not understand the benefits of such a system,â€? adds Dr Naik. There are speculations amongst experts that this could lead to an increase in the cost of drugs. The percentage of the hike is, however, at present, unclear. Nayantara Som ]]> <![CDATA[PPP: Fueling research and development]]> https://biospectrumindia.com/news/95/2186/ppp-fueling-research-and-development.html https://biospectrumindia.com/news/95/2186/ppp-fueling-research-and-development.html Mon, 14 Nov 2011 11:54:00 +0530 In this issue of BioSpectrum the Public Private Partnership Case Study Series showcases the work of an organization, set up under public-private partnership, in sequencing and analyzing the genome of a higher organism. The other two companies featured have utilized funding by the government to find home-grown solutions to expensive and imported vaccine and diagnostic kit. Ganit Labs, a public-private partnership between Strand Life Sciences and the Institute of Bioinformatics and Applied Biotechnology, sequenced and analyzed the entire genome of Neem tree With BIPP funding, Amar Immunodiagnostics finds an answer to the imported and expensive diagnostic kits for autoimmune diseases Tergene Biotech uses Department of Biotechnology's help to develop a vaccine for pneumonia that is more affordable ]]> <![CDATA[Mission: Vaccine to fight pneumonia deaths]]> https://biospectrumindia.com/news/95/2008/mission-vaccine-to-fight-pneumonia-deaths.html https://biospectrumindia.com/news/95/2008/mission-vaccine-to-fight-pneumonia-deaths.html Mon, 14 Nov 2011 11:34:00 +0530 Utilizing the funding from BIPP, Tergene Biotech initiated a project to develop an indigenous vaccine to tackle pneumonia that kills more children under the age of five than any other disease Pneumonia kills an estimated 1.6 million children under the age of five globally, every year, according to statistics available with the World Health Organization. The number is more than the combined deaths due to AIDS, malaria and tuberculosis in this age group. The report card released by the International Vaccine Access Center says, in India, pneumonia claims lives of more than 3.7 lakh children every year. The above facts together with the realities that indigenously manufactured vaccines for the disease are non-existent in the country and the high cost of imported vaccines necessitate the development of affordable indigenous technology and manufacturing capabilities. Keeping this in mind, Hyderabad-based company Tergene Biotech launched a project to develop a 15-valent pneumococcal polysaccharide conjugate vaccine with CRM 197 as the carrier protein. The objective is to make it India-specific and affordable to the common man. The company, a third generation technology development company in the field of vaccines and therapeutic proteins, received a grant of `15 lakh from the Department of Biotechnology (DBT) to demonstrate proof-of-concept at lab-scale under the Biotechnology Industry Partnership Programme (BIPP) scheme. The company received the grant after the DBT called for affordable healthcare technologies with specific reference to pneumococcal conjugate vaccine in November 2010. Explaining the technology, Dr M Kuppusamy, managing director of Tergene Biotech, says, â€œThe 15 serotypes used in our vaccine account for 80 percent of the total serotype prevalence in India. The company has developed its own in-house technology to manufacture the carrier protein. CRM 197, the safest and highly immunogenic carrier protein of choice, together with the flow chemistry-based conjugation constitutes the platform technology for all its polysaccharide-based conjugate vaccines.â€? Tergene also had the options to develop a Haemophilius influenzae B conjugate vaccine and acellular pertussis vaccine directed to prevent the main causative bacterial agents of pneumonia, but is presently focused on the pneumococcal polysaccharide conjugate vaccine. â€œWe are thankful to the DBT for the timely initiative. A public private partnership is a real opportunity for start-ups promoted by scientists with technology as the prime investment,â€? says Dr Kuppusamy. The way forward The company is setting up a manufacturing facility (as per Good Manufacturing Practices norms) near Chennai, Tamil Nadu. The state-of-the-art facility will be operational by mid 2013 and will be used to manufacture vaccines, biopharmaceuticals and probiotics. This will give Tergene a manufacturing facility matching the specifications of the US Food and Drug Administration. The company is hopeful of receiving further support from the DBT to complete the cGMP clinical lot manufacturing, clinical trials and eventually commercial manufacturing. â€œAccording to estimates, we would be in a position to launch the vaccine in 24 months,â€? says Dr Kuppuswamy. He said they were confident of pricing the vaccine at one-third the cost of the imported vaccine, which is available at an MRP of Rs 3,800 per dose. â€œAs per recommendations, infants require four doses of the vaccine,â€? he adds. Rahul Koul in NewDelhi ]]> <![CDATA[Mission: Diagnostic kits for autoimmune diseases]]> https://biospectrumindia.com/news/95/1406/mission-diagnostic-kits-for-autoimmune-diseases.html https://biospectrumindia.com/news/95/1406/mission-diagnostic-kits-for-autoimmune-diseases.html Mon, 14 Nov 2011 11:32:00 +0530 The BIPP funding helped Amar Immunodiagnostics develop cost-effective kits that are now at the final testing stage Amar Immunodiagnostics embarked on a project to develop diagnostic kits for autoimmune diseases in India to make them affordable and to provide proper medical care to people. Mostly, the diagnostic kits available in the country for detection of autoimmune diseases are all imported, expensive and beyond the reach of the common man. An amount of `13 lakh provided by the Biotechnology Industry Partnership Programme (BIPP) helped the company start the project. â€œWe made an application for developing diagnostic kit for detection of all autoimmune diseases before the BIPP. The DBT requested us to work on tissue transglutaminase (Celiac disease). Recently, it called for more applications for research in understanding autoimmune diseases in India,â€? said Dr Jayant Bhanushali, director-R&D, Amar Immunodiagnostics. The project was funded in April of 2011 for a seven-month period. The company has already developed the kit, and the project is in the final quality testing stage. Amar Immunodiagnostics, a private company, was the first to market LH, FSH and Prolactin ELISA kits in India in early 1986. Having started with importing ELISA-based diagnostic kits, the company then started manufacturing the kits. At present, the company manufactures more than 20 ELISA kits in India. The company also diversified into developing and manufacturing GMO testing kits to detect genetically modified plants, such as Bt cotton, maize, brinjal and soybean. Some of its kits are approved by multinational corporations, and for many of these kits, it is the only manufacturer in Asia. The company has its own monoclonal and polyclonal antibodies facilities, and has developed in-house expertise to develop kits directly from DNA sequences. The unique selling point of this expertise is that it is not necessary to have purified protein to develop antibodies or the immunoassay-based diagnostic kit. According to the company, all the kits manufacured at the company conform to US FDA guidelines on specificity, reproducibility, stability and other specifications required by regulatory agencies. The way forward The company has tied up with Sanjay Gandhi Post Graduate Institute of Medical Sciences (SGPGI), Lucknow, for testing the autoimmune disease kits for quality. According to Dr Bhanushali, the company tied up with the SGPGI because of the latter's experience in this field and to ensure stringent quality checks. â€œI think public private partnership is a very good idea but it should be time-bound. The government agencies have their own priorities and the projects at times get delayed,â€? said Dr Bhanushali. He said they have developed two GMO kits - genes for them were developed by scientists in India - and the company is the only manufacturer of those kits in the world. â€œWe have made a small beginning by exporting our kits to China,â€? he said. Rahul Koul in NewDelhi ]]> <![CDATA[Mission: Sequencing a higher organism]]> https://biospectrumindia.com/news/95/1952/mission-sequencing-a-higher-organism.html https://biospectrumindia.com/news/95/1952/mission-sequencing-a-higher-organism.html Mon, 14 Nov 2011 11:23:00 +0530 Ganit Labs, a public private partnership between Strand Life Sciences and the IBAB, sequenced the entire genome of Neem tree making it the first institute in India to successfully sequence and analyze the genome and transcriptomes of a higher organism High on its achievement of sequencing the genome of Neem tree, Ganit Labs from Bangalore presents a perfect example of a public private partnership making a powerful impact in the life sciences industry. Housed in the Institute of Bioinformatics and Applied Biotechnology (IBAB), Bangalore, Ganit Labs is a very young initiative with a strength of 15 people. The not-for-profit organization, operational since February 2011, aims to focus on India-centric problems. Ganit Labs was started when the Government of India solicited proposals to develop a Bio IT lab in India a few years ago. The Government of Karnataka and Strand Life Sciences were chosen to be a part of this initiative. It received `10 crore from the Department of Information Technology, Government of India, and `5 crore from the Government of Karnataka. Strand Life Sciences too invested `5 crore worth in software and marketing services rendered. Dr Binay Panda, chief officer and head, Ganit Labs, says, â€œThis model of a public private partnership (PPP) allows us to draw the strengths of both parties involved and at the same time be fiercely independent in pursuing our agenda. In addition to carrying out research, we also aim to be a center attracting and training talent in the form of young students. The location of the lab is a big advantage as we get talented students from the IBAB and, in return, the students are exposed to the research using cutting-edge tools at our lab.â€? Speaking about the sequencing of Neem, Dr Panda says, â€œTo the best of our knowledge, this is the first de novo sequencing and analysis of a genome and its various transcriptomes of a higher organism in India using sophisticated next generation sequencing tools. Neem has long been a tree synonymous with Indian culture. Its sequencing will further enable us to study the associated signaling pathways and validate the traditional knowledge, while producing scientific data about its various compounds, including azadirachtin, one of its most potent compounds. We also aim to carry out further research to identify other compounds from sequence data, which later will be used on the basis of their medicinal or pesticidal properties.â€? The way forward One of the striking features of this project is the fact that the sequence information generated is slated to be uploaded on an open access portal in the next few months, which will be made accessible to all, allowing scientists and students to utilize this information in their research. In addition to conducting the projects, the lab aims to be self-sufficient and has undertaken a few sequencing projects for other scientists and organizations. The lab hopes to attract young minds through initiatives such as 'My idea', which allows students to write a proposal on their idea and if selected it is translated into a project. Ganit Labs has also started another project in close collaboration with the Mazumdar-Shaw Cancer Center to profile oral cancer patients and identify markers associated with oral cancer by comparing the genomes of tumor with that from the normal tissue of the same patients. This can help in the development of a diagnostic for oral cancer. Manasi Vaidya in Bangalore ]]> <![CDATA[CSO cover]]> https://biospectrumindia.com/news/95/5160/cso-cover.html https://biospectrumindia.com/news/95/5160/cso-cover.html Mon, 14 Nov 2011 11:20:00 +0530 The oceans are a vast reserve of medicinal herbs, fungi, bacteria and algae. Scientists and marine biotechnologists have been trying to unravel the deep mysteries inside the ocean for the benefit of mankind. However, compared to the other fields of biotechnology, the progress in marine biotechnology has been slow due to lack of awareness, policy frame work, human resources, instrumentation, funding and a few other factors. But the fast depleting land resources and the inavailability of land has led to considerable exploitation of marine living resources. In this issue, the CSO series focuses on the work of two scientists: Dr S Raghukumar, MD, MykoTech, Goa, and Dr Dinabandhu Sahoo, scientist, University of Delhi, who are carrying out research in the field of marine biotechnology. ]]> <![CDATA[Focus on fungal benefits]]> https://biospectrumindia.com/news/95/3875/focus-on-fungal-benefits.html https://biospectrumindia.com/news/95/3875/focus-on-fungal-benefits.html Mon, 14 Nov 2011 11:18:00 +0530 Dr Seshagiri Raghukumar managing director, MykoTech, Goa Much has been attributed to the benefits of deep sea fungi. Fungi from coastal environments have been widely studied with respect to the production of secondary metabolites and biotechnologically useful lignocellulolytic enzymes. Working in this area, Dr S Raghukumar has done some innovative research that promises to deliver products. Dr Raghukumar, after completing his master's degree in Botany from University of Madras, pursued his PhD on marine fungi under the guidance of the famous mycologist, Professor CV Subramanian, at the Center for Advanced Studies in Botany, University of Madras, from 1967 to 1972. He worked as a scientist at the Institute for Marine Research, Bremerhaven, Germany, between 1976 and 1981, during which he was groomed by Dr Alwin Gaertner in taxonomy and ecology of the marine fungi, belonging to thraustochytrids. In 1982, Dr Raghukumar joined the National Institute of Oceanography (NIO), Goa, and worked there on major marine biotechnological areas until 2004. His major research interests were biology of the marine protists, thraustochytrids, biomass of fungi and thraustochytrids in marine samples, the ecology and taxonomy of marine wood-degrading fungi, microbiology of marine detritus, microbiology of the Arabian Sea and marine biotechnology. In addition, he taught several courses in marine microbiology, biodiversity and biotechnology. Dr Raghukumar has published more than 60 original research papers on these topics in numerous international and national journals. He is a holder of several Indian and US patents in the area of marine biotechnology. After working for 22 years at the NIO, Dr Raghukumar felt the need to move on and establish a marine biotech company. He set up MykoTech in the year 2004. The company is now a proud possessor of a culture collection of more than 1,000 fungi and several bacteria. The primary task of the company is the establishment of a unique microbial culture collection. Presently, rare and novel fungi are being isolated from a variety of terrestrial and marine ecosystems. In microbial metabolites research, MykoTech carries out screening of its microbial cultures for omega-3 polyunsaturated fatty acids (PUFA), biofuel, industrial intermediates, cosmetics, biormediation, nutraceutical compounds, pharmaceutical compounds and industrial enzymes. One major technology that MykoTech has developed is that of extracellular melanin production by a fungus, for which a patent has been filed. The compound has tremendous potential for use in cosmetics as a gamma-radiation protectant and also in research. â€œAnticancer and antidiabetic assays are in progress. Clearly, more research needs to be carried out before the usefulness of these biotransformed compounds can be confirmed. However, we believe that this would be a useful process even at this stage of research,â€? says Dr Raghukumar. The leadership of Dr Raghukumar has led MykoTech into developing many technologies, such as water soluble melanin from a fungus for application in cosmetics, optics, offering protection against UV and gamma radiation and by other industrial applications. The company has also developed technologies for production of enzymes alpha-amylase, alpha-galactosidase and tyrosinase; a process to improve active principles from medicinal plants using biotransformation; and production of omega-3 polyunsaturated fatty acid and docosahexaenoic acid (DHA). The company plans to license out or sell some of its technologies to interested parties. Dr Raghukumar cites the lack of access to analytical facilities and the absence of biotechnology incubators as one of the major factors that hamper research. However, being a firm believer in innovation, he says, â€œIt is the most important aspect that will help new companies to overcome the intense competition that exists in biotechnology industries.â€? ]]> <![CDATA[Creating wealth from algae]]> https://biospectrumindia.com/news/95/7217/creating-wealth-from-algae.html https://biospectrumindia.com/news/95/7217/creating-wealth-from-algae.html Mon, 14 Nov 2011 11:16:00 +0530 Dr Dinabandhu Sahoo, scientist Marine Biotech Lab, Dept of Botany, Delhi University The seaweeds' industry is worth more than $8 billion per year. One particular seaweed, Porphyra, (used in a Japanese delicacy called Sushi) is a $2 billion industry. The demand in this sector is increasing at the rate of 10 percent every year. There are many marine algae that are excellent sources of poly unsaturated fatty acids (PUFA) and have wider applications. Antioxidants' production from marine algae is another important area. After doing his master's degree in botany at the University of Delhi, Dr Dinabandhu Sahoo did his PhD on peanuts and groundnuts. Dr Sahoo traveled to the coastline of the Bay of Bengal in search of an exciting area of marine algae. The next challenge was to stay in New Delhi and work in the field of marine biotechnology. â€œEven today I face the same question from many quarters. How can I work in the domain of marine sciences by staying in Delhi? My answer is very simple. If you want to work on space you do not need to set up your lab in space,â€? says Dr Sahoo, who was the first Indian student to visit Antarctica during 1987-88 as part of the 7th Indian Scientific Expedition to Antarctica. He subsequently undertook two trips to the Arctic between 1991-1992. Dr Sahoo contributed substantially to the field of marine algae and applied his scientific knowledge in product development and employment generation at the grassroot level for the socio-economic development of the people living in coastal areas. He has extensively worked in the field of seaweed cultivation and utilization using the concept of generating wealth from waste. Based on his 20 years of work experience on Chilika Lake, he has developed a model called the 'Chilika Model' for the socio-economic upliftment of the fishermen community in different parts of Indian coasts. This pioneering Chilika model led the Department of Science and Technology, Government of India, to formulate the First National project on large scale seaweed cultivation and processing for livelihood generation in different coastal states and Union Territories of India. This pioneering work has earned him a spot amongst the 20 social entrepreneurs of the country in the best seller, I Have a Dream. Based on the same subject, Dr Sahoo has co-directed a documentary film 'Chilika and Untold Story'. Presently, Dr Sahoo is the secretary of Indian Phycological Society and is also involved in teaching and research at the Department of Botany, University of Delhi. Marine algae, popularly known as seaweed, are a good source of food, feed, fertilizer, chemicals and pharmaceuticals among others. The seaweeds' extracts are used in toothpaste, cosmetics, ice cream, chocolate, food processing, meat processing, juice, tomato ketchup, beer refining, textile printing, syrup making and a number of other industries. Talking about his research, he says, â€œOut of the 770 species of seaweeds, growing in Indian coasts, we have only selected four commercial species for large scale field production.â€? During the last few years, he has been working on developing huge biomass production. Next-, he plans to set up the world's first integrated marine algae biorefinery in India, based on zero waste concept. He has been in talks with a few agencies and private players. Besides that, he is also trying to guide some new young entrepreneurs in this field. Dr Sahoo's pioneering work has led to the invention of 'carbon dioxide capture box', which can capture CO2 from automobile exhausts. He believes that based on marine biotechnology, the world can move towards blue carbon economy, and this is his goal. His dream is to create a million jobs in rural areas through the application of marine biotechnology and become a guiding force in life science with a human face. Rahul Koul in NewDelhi ]]> <![CDATA[The Down-Under Leverage]]> https://biospectrumindia.com/news/95/2249/the-down-under-leverage.html https://biospectrumindia.com/news/95/2249/the-down-under-leverage.html Tue, 11 Oct 2011 12:03:00 +0530 Nandita Singh The author is Editor of BioSpectrum nanditas@cybermedia.co.in Biotech has arrived at a theatre close to you, at least in Australia. The latest film The Hunter from the Australian film industry is a thriller-story of a clinical mercenary on a mission to capture the last Tasmanian tiger for a biotech company with questionable motives. The Tasmanian tiger has been officially extinct since 1936 and in the last 10 years, there have been efforts to clone the tiger from preserved DNA samples in Australia. The project was ultimately given up due to degraded samples. However, latest research in the biological field, it is said, could well re-open the possibility of a clone. The country is at the forefront of cutting edge R&D in the Asia Pacific region. To capitalize further on its clever-talent pool, earlier in September, this year, the Australian government announced an R&D tax incentive that almost doubles the support for small firms to 15 cents in a dollar. It starts retrospectively from July 1, 2011 and is not limited to life sciences but cuts across sectors. In fact, these incentives are directed at innovation with clean technology in view. This apart, the 2011 Australian of the Year, Mr Simon McKeon, is chairing an independent review of health and medical research in Australia and will recommend a 10-year strategic health and medical research plan for the nation. In this initiative, he will be joined by Prof Ian Frazer, Mr Bill Ferris AC, Ms Elizabeth Alexander, Prof Henry Brodaty, and Prof Melissa Little among others. As far as Australia goes, the good news is not limited to just research and development or policy direction. It is a great market, given its good access to medicine and the growing aging population. The pharma companies can certainly leverage on this market need. For example, India-based pharma company Ind-Swift Laboratories has recently closed on this opportunity. Positioned as a provider of APIs to generic players for regulated markets, Ind-Swift has received approval from Australia's Therapeutic Goods Administration (TGA) to manufacture seven APIs, including Clarithromycin and Letrozole at its facilities located in India. The company is looking at doubling its turnover by 2015 to cross $500 million in revenue. Australia and Japan form a big part of its strategy. And this is just one example. Australia as a country is still under-leveraged by the rest of Asia and therein lies another opportunity. Just like in the film, The Hunter, which is a tale of an individual with a tough objective in the wilderness - a metaphor for globalization - challenges and opportunities abound. The key is in adapting. By the way, this movie is based on a novel by the same title The Hunter authored by Australian Julia Leigh. It was published in 1999. ]]> <![CDATA['The distribution hub will help Invitrogen grow faster']]> https://biospectrumindia.com/news/95/2795/the-distribution-hub-will-help-invitrogen-grow-faster.html https://biospectrumindia.com/news/95/2795/the-distribution-hub-will-help-invitrogen-grow-faster.html Tue, 11 Oct 2011 12:00:00 +0530 INTERVIEW Mr Devashish Ohri, MD, Life Technologies, South Asia Life Technologies, a global biotechnology company that operates as Invitrogen Bioservices in India, launched a regional distribution hub in the country during July to address the strong customer demand of the South Asian region. The new India distribution center (IDC), located in Bangalore, will boost the availability, timely delivery and quality of Life Technologies’ products in the area. The India distribution center, spread across an area of 25,000 square feet, adopts a hub-and-spoke model, with Bangalore as the regional hub for product distribution throughout India. Since its inception, Life Technologies’ volume of items shipped per day in the region has increased four-fold, with dramatically improved order fulfillment time, which was up to 50 percent faster in most cases. Life Technologies, which commenced operations in 2005 from Bangalore,  India, acquired a part of Labindia, a long-time distributor for its Applied Biosystems-branded instrument products. The firm has become a full service business that offers end-to-end solutions in areas such as research, diagnostics and forensics. In an interview with BioSpectrum, Mr Devashish Ohri, managing director of Life Technologies, South Asia, shares his plans and speaks about the opportunities in India and South Asia of the company. Excerpts from the interview: Q  How much investment has Life Technologies made in setting up the IDC in Bangalore? What is its USP? Life Technologies has invested around $3 million to open a new distribution hub in Bangalore.  The IDC will help us in accelerating delivery and in shaping discovery in India by creating localized solutions, like product and technology availability, ensuring faster turnaround time in product delivery, creating best-in-the-class facility, and also help make available a wide range of products and specialized technology in India. We are also committed to understanding the groups of customers that we serve and their exact needs. Q  With the growth of the scientific community in India and the opening of the IDC, how do you see the growth of Life Technologies in India and South Asia? With the IDC, we’re fulfilling our commitment of accelerating scientific exploration by researchers and shaping discovery. We’ll be able to provide customers with the products they need within 24 hours to 48 hours. This timing better suits the dynamic needs of our customers. This important milestone will definitely help us to accelerate science in the country and will help Invitrogen grow faster than the existing market growth rate. This exciting growth curve will also be supported by an extensive sales, scientific support and service network of Life Technologies. Q  What are the other initiatives taken to serve customers in the South Asia? We are committed to the growth of India’s biotechnology sector. The IDC is one of the strategic investments in this direction. Apart from this initiative, we’re also involved in R&D in specialty areas, like stem cells and bioinformatics; manufacturing capabilities for cellular analysis products; technical and customer support team to support global markets; and best–in-the-class demonstration labs where customer can work on a wide range of technologies and equipment to get hands-on experience. Q  Pricing is a key factor in South Asia. How do you address this issue to increase customer base? We understand the importance of quality products and optimal pricing for customers. We are working on pricing models that are dynamic in nature and are able to incorporate local pricing needs to reach the middle and the bottom of the pyramid for value-conscious customers. The IDC initiative will definitely help to address this issue to a certain extent. Q  In a country like India, which has a vast geography, networking and distribution are important. How has the acquisition of Labindia in 2010 helped? Life Technologies was created by the combination of Invitrogen Corporation and Applied Biosystems and, as you already know, Life Technologies operates in India as Invitrogen BioServices India, a 100 percent subsidiary company, to leverage our systems, consumables and services; and to enable researchers accelerate scientific exploration, driving discoveries and developments that make life better. We have offices located in Gurgaon, Mumbai, Kolkata and Bangalore and we have a strong distributor chain and commercial team of about 100 people. This helps us to cater to the vast geography and meet different customer needs. Please elaborate on your India R&D center. Life Technologies’ winning formula relies on its integrated state-of-the-art lab facility in Bangalore, where the R&D is focused on development of proprietary technologies in immunology and stem cell. The manufacturing division is tailored for production of the products developed on site for global usage. The vision for India is to build a center of excellence focused on innovation and quality with the goal of improving human conditions.  Q  What are the other major challenges before suppliers in India and South Asia? We have a customer-centric business model coupled with reliable and innovative brand value, strategic leadership, strong service delivery, a dedicated workforce and a global presence. The major challenges from a supplier’s perspective remain regulatory issues, the dynamic nature of science, evolving applied markets, and matching business process standards vis-à-vis developed markets, like in the US and Europe. — Narayan Kulkarni ]]> <![CDATA['We are looking for exciting opportunities']]> https://biospectrumindia.com/news/95/2540/we-are-looking-for-exciting-opportunities.html https://biospectrumindia.com/news/95/2540/we-are-looking-for-exciting-opportunities.html Tue, 11 Oct 2011 11:57:00 +0530 INTERVEIW Mr Hemant Sharma, Director-market development, QIAGEN India In 1984, QIAGEN was founded as a spin-off at the University of Düsseldorf, Germany. Today, it is the world’s leading provider of innovative sample and assay technologies for research in molecular diagnostics, applied testing, pharma and academic research. QIAGEN employs more than 3,700 people in over 35 locations, worldwide. The company directly entered India in January 2011 and is aiming to consolidate its business here. In an interview with Mr Hemant Sharma, director-market development, QIAGEN India, BioSpectrum tries to find out the reasons behind the company’s direct entry in India, the challenges before it, its future outlook and more. Q  Brief us on the history of QIAGEN in India? QIAGEN products have been in the India market for the last 18 years. Earlier, we were working through channel partners. Now, with a direct presence in the market, we have appointed new channel partners and are working with over 30 distributors. After joining QIAGEN in 2008, when the company representative office was set up in Delhi, I was involved in the registration process of the company in India. With the establishment of a subsidiary in New Delhi and the expansion of our team, we officially entered the India market in January 2011. Q  What were the reasons behind your direct entry into India? How has it helped you and did you face any challenges? We always say that India and China are the two big upcoming markets. Approximately 12 percent of our global revenue comes from the Asia-Pacific market. Our presence in China, since 2004, helped us consolidate our base in these markets. There has been a huge growth in China and we consider the dynamics of this market similar to the Indian scenario. Therefore, to have more interactions with our customers and provide them timely and quality services, it was important for us to have our direct presence in the market. When starting a new venture, you are bound to come across various difficulties. However, I would not like to call these hiccups or challenges. Rather, it is part of the normal process. Currently, we have 36 employees, besides having sales and marketing professionals. The company provides technical service too. There are hotline numbers and Indian customers can call directly and are directed to the global technical team for help. Moreover, we have our own warehouse in NewDelhi and, in a short period, we have managed to assemble a very good team. Now, we are looking for a great start and plenty of exciting opportunities. Q  What kind of product range are you offering? Which are the future potential opportunity areas for your company? QIAGEN is a leading provider of sample and assay technologies. We have developed and market more than 500 consumable products and automated solutions. The company provides these products to molecular diagnostics laboratories, academic researchers, pharmaceutical and biotechnology companies, and applied testing customers for purposes such as forensics, animal or food testing and pharmaceutical process control. QIAGEN’s assay technologies include one of the broadest panels of molecular diagnostic tests available worldwide. This panel includes the digene HPV test, which is regarded as a “gold standard” in testing for high-risk types human papillomavirus (HPV) which is, the primary cause of cervical cancer, as well as a broad suite of solutions for infectious disease testing and companion diagnostics. The molecular diagnostics markets in China and India are growing rapidly, approximately 15 percent on a year-on-year basis. Similarly, the next big area of opportunity is the PCR market, which, in India, is growing by 22 percent every year. From these numbers, it is easy to see that the Indian market has great opportunities in these areas. Q  How has been your financial performance and which areas of opportunity are you looking at? As of now, we can’t give specific figures as far as revenue is concerned. Since we have set up our offices only recently, it will take some time for us to reach a considerable revenue figure. Since Asia Pacific contributes close to 12 percent of the global revenue, we are looking at China and India to further fuel this growth. We are solution providers and are looking forward to providing the best services to local customers. Our Asia Pacific region has been growing at double digit rates. By expanding geographically and extending services over the next three to five years, India will become a substantial part of our revenue. Q  Can you compare the markets in India and China to those in the rest of the developed world? We started our operations in China in May 2004 with eight employees and, since then, we have grown to be a 350-people company there. Currently, we have offices at all the major locations in China and we want to see the same example being replicated here in India. Although China differs in various aspects, such as regulations and infrastructure, but there are few similarities too. Given the burden of disease, there are huge opportunities in healthcare. We have vital technology to tackle the same and are thus in a unique position to address this burden. We are also working with pharma companies and CROs to drive innovation in drug development. Therefore, there is a plenty of scope in both these markets. When India and China are compared with the markets in the West, there is surely a difference. For example, the healthcare needs of Germany and the UK are different that of India and China. Similarly, our R&D in Germany is to address the specific needs of developed healthcare economies and our R&D in Asia is to address the unique needs of the Asia Pacific markets. We are trying to come up with innovative ideas. — Rahul Koul in New Delhi ]]> <![CDATA['We look forward to achieving 35 percent growth']]> https://biospectrumindia.com/news/95/1605/we-look-forward-to-achieving-35-percent-growth.html https://biospectrumindia.com/news/95/1605/we-look-forward-to-achieving-35-percent-growth.html Tue, 11 Oct 2011 11:56:00 +0530 Mr Anil Panwar CEO, Fortis Clinical Research Established in 2005, the Fortis Clinical Research Limited (FCRL) is a full service contract research organization based in Faridabad, Haryana. The company is focused on facilitating drug development efforts of the pharmaceutical, biotechnology and device companies across the globe. The FCRL is part of Fortis group, which is promoted by Mr Malvinder Mohan Singh and Mr Shivinder Mohan Singh. In an exclusive interview with BioSpectrum, Mr Anil Panwar, who has recently taken over as the chief executive officer of Fortis Clinical Research, shared his views on the company operations, challenges and the outlook of the company. Q What edge does the FCRL have over other players in the CRO space? Mr Panwar: There are many areas where we are ahead of our competitors. Our central laboratory was India’s first to get ISO 15189:2007 NABL and CAP accreditation. We have 45 laboratories across India with 1,200 collection centers. We also have experience of over 550 clinical trials for over 35 therapeutic segments. We have a 24-hour dedicated sample archiving facility, dedicated clinical research service department and real time web-based online reporting systems. We extend the services to about eight million patients annually. The FCRL team excels in end-to-end management of phase I, II, III, IV trials and bioavailability and bioequivalence studies. Having 55 super-specialty hospital networks with international presence has also helped us a lot. Fortis sites have been the highest recruiting sites in many global studies. We have conducted over 350 studies in the last five-to-six years. Faster site identification and selection due to pan India presence, central lab, and data management smoothens the clinical trial logistic management and operations. Besides that, we have a network of experienced physicians and coordinators across India, which is continuously expanding. Q What are your areas of strength? What steps have been taken to maintain quality? Mr Panwar: Our therapeutic expertise lies in the areas of oncology, cardiology, ophthalmology, gastroenterology, and infectious diseases. Our project managers, with vast therapeutic area expertise, have more than seven years experience in study management. Besides that, the team of qualified and experienced employees in operations with medically qualified doctors, look after end-to-end project management and operations. The team has worked on various global clinical trials and successfully cleared many global audits and inspections. We also have the required expertise in developing protocols, manuscripts, clinical study reports with quick turnaround time and focus on quality control. Our clinical team comprises medical doctors, registered nurses, technicians, and medical assistants who have expertise in conducting phase I studies irrespective of the fact whether the volunteers are healthy or patients suffering from various ailments. We have also got expertise in end-to-end management of phase II–IV clinical trials. To support the clinical data management and biostatistics services, we have SAS programing with a data management team, including biostatistician, SAS programers, quality auditors, medical data validation and data entry operators. Our company has been approved and audited by regulatory agencies across the globe. These include the approval to conduct BA/BE studies by the DCGI (India) in January 2006. The company was audited by it on January 2011. Audits were also done by AFSSAPS (France) in February 2008, ANVISA (Brazil) in March 2006, August 2007 and August 2009. The USFDA has also successfully audited us on July 2010. The experienced quality assurance professionals at the FCRL work with clients to conduct internal and external GCP audits. All studies performed are audited by our quality assurance department according to the FDA regulations and the ICH-GCP guidelines. Q How do you visualize growth of the CRO industry in India? Mr Panwar:  The industry is growing at a good pace. The size of the industry is roughly estimated at 3,000 crore. It is growing at an annual growth rate of 20 percent. The major advantages in India are cost-effectiveness, knowledge and availability of cheap manpower. However, it is yet to reach a level that was expected. The expectations have not been met because of certain issues. Among these are the unavailability of enough qualified manpower, mushrooming of unethical CROs, unwanted delays in regulatory affairs and competition from other countries. Therefore, we need to evolve fast and catch up with the competition that may overtake us completely, if we do not address the issues proactively. Q What challenges does the Indian regulatory structure pose for the clinical trial industry? Mr Panwar: The regulatory process needs to be changed and enforced strictly. There is a huge requirement for changes. It is understandable that healthcare had taken a back seat earlier because food and shelter were the primary focus areas. However, with the increasing income levels, there has been a major shift towards addressing the healthcare needs of the masses. The government can train people in e-filing and they also need to adhere to timelines. On the part of the industry, we must also gear up and start discussing with various government agencies. Our associations need to play a more active role now. The major challenges include delays in approvals. The mushrooming of a few small unethical CROs are bringing a bad name to the entire industry. A minimal qualification should be there for the establishment of CROs and a basic standard has to be set so that people do not come into this line only for business interests. The lack of enough inspectors in India is also one of the issues that needs to be looked into by the government. There is the need to provide international exposure to these inspectors. Electronic filing with the DCGI must be welcomed. Q What is your response to allegations that informed consent is not taken by CROs before trials? Mr Panwar: There may be some unethical small-time CROs who do that but the big and responsible CROs never indulge in such actions as it is not good for their well being. In our case, we take extra precaution while going for trials. We inform the patients well in advance about the consequences. The patient is offered a free healt check-up and, on the basis of that, it is decided whether to go ahead with the trials. We also need to be conscious of the fact that the patient might, at times, be uneducated and, therefore, to overcome the communication gap, a person of the same language or background is used as an interpreter to convey the message. Doing the video recording of the entire process is also an option that can prove helpful in this regard. Q Where do you see your company five years from now? Mr Panwar:  We will be looking forward to achieving close to 35 percent growth in the coming years. I wish to see the company occupying the top position in the CRO space in due course of time. — Rahul Koul in New Delhi ]]> <![CDATA[Industry leaders take MARKET CHALLENGES HEAD-ON]]> https://biospectrumindia.com/news/95/6745/industry-leaders-take-market-challenges-head-on.html https://biospectrumindia.com/news/95/6745/industry-leaders-take-market-challenges-head-on.html Tue, 11 Oct 2011 11:45:00 +0530 Industry leaders take MARKETCHALLENGES HEAD-ON It is both exciting and challenging for the biotechnology industry in India. While significant mergers and acquisitions are changing the shape of the industry, the sector is throwing up new challenges in the form of patent issues, regulatory hurdles and impediments, such as information gap, in marketing products. In an effort to understand the dynamics of the industry, BioSpectrum asked industry leaders to share their experiences and views on market challenges and ways to overcome them to move ahead on the growth path. Read on to find out what they have to say. Market Challenges BioTechnology>> BioAgriculture>> BioServices>> Manufacturing>> BioPharma>> BioInformatics>> ]]> <![CDATA[Small firms lack marketing set-up]]> https://biospectrumindia.com/news/95/2796/small-firms-lack-marketing-set-up.html https://biospectrumindia.com/news/95/2796/small-firms-lack-marketing-set-up.html Tue, 11 Oct 2011 11:36:00 +0530 Dr Biswajit Roy Founder & MD, Chromous Biotech The author did PhD in molecular biology from the Bose Institute, Kolkata, and has four years of post-doctoral research experience from the Cleveland Clinic Foundation, US. He also has 11 years of experience in firms engaged in molecular biology research. There are distinctions between pharmaceutical and molecular biology products, though they are all clubbed together as biotechnology products. Manufacturing capabilities and technological challenges for both are very distinct. While the pharma industry in India is on a high, there are only a handful of molecular biology product manufacturers in the country. Chromous Biotech is an original manufacturer of molecular biology products from India and one of the few such companies in the world. The biotech companies involved in manufacturing of molecular biologicals have a few common special features that influence their market performance: Most molecular biology companies spend 25 to 30 percent of their revenue on R&D. Most companies are highly rich in technology. The established and highly branded molecular biology companies have multi-billion dollar revenues with global presence. Continuous aggressive consolidations are taking place in the industry as larger companies are buying smaller technology-rich companies to maintain dominance in the market. Most companies practice variable pricing in different countries to remain competitive. The countries with no indigenous molecular biology companies suffer greatly because of lack of bench-marking. The protocols of storage, shipment and handling of products are critical and temperature sensitive. Most MNCs have distribution centers in India for stocking and quicker supply of products. To better understand the challenges of marketing of molecular biology products in India, we are required to understand a few salient features of the business: The industry has the most learned brand of customers. All are scientists from research institutes and universities. An estimated 500 institutes with around 20,000 scientists working in the field of molecular biology in India spend around 500 crore annually. Brand value and confidence on product quality matters a lot. Most prominent foreign-bound scientists prefer branded products even if local reliable alternatives are available. The acceptance of products (from even highly branded companies) depends a lot on factors that are not within the control of the companies. This is because of the presence of variables with sensitive implications in every molecular biology experiment. Thus, while one scientist can vouch for Invitrogen to be the best, another may prefer New England Biolab’s products. Very often, the purchasing authority of the institutes is not clear. It can be the purchase department or PhD students and scientists themselves who makes the decisions. Marketing challenges Marketing activities of biotechnology companies in India are probably not as organized and efficient as the multinational companies because they lack proper infrastructure. The MNCs have the resources for setting up well-structured marketing set-ups and are willing to nurture their brands with a strong scientific approach over a period of time. The availability of resources is not a constraint for them unlike the smaller biotech companies. The MNCs also invest heavily on brand development which allows them to maintain pricing at high premium. This gives them the leverage for marketing costs. Indian companies hardly have the resources for the same. Most MNCs invest heavily on R&D and hold patents on groups of products or technologies. The innovator would derive valid edge over competitors. Average Indian first-generation start-up companies are not able to invest in R&D due to lack of investments from financial Institutions in India. Also, the wealth of marketing information of MNCs in other geographies is very useful. Chromous Biotech, established in 2006, took the direct marketing approach where the marketing team approached scientists and institutes directly for business. It initially helped the company in brand development. The customers typically associate well to the company in this way. The scientists get better service in terms of scientific feedback and troubleshooting as most marketing and sales team members are post-graduates themselves. Profitability also remained high as distributors’ margins are saved. The drawbacks were that coverage remained poor as the team members could only reach a handful of customers. The collection of payments was the biggest shortcoming. To continue the growth of Chromous Biotech in terms of revenues (that became stagnant because of limited coverage), the company then involved distributors to increase its coverage. Currently, the company has 53 authorized distributors to serve scientists from all major research institutes of India. ]]> <![CDATA[Pursue regulatory innovation for outreach]]> https://biospectrumindia.com/news/95/1550/pursue-regulatory-innovation-for-outreach.html https://biospectrumindia.com/news/95/1550/pursue-regulatory-innovation-for-outreach.html Tue, 11 Oct 2011 11:34:00 +0530 Dr Kiran Mazumdar-Shaw CMD, Biocon The author has been named among TIME magazine’s 100 most influential people in the world. Under her stewardship, Biocon has evolved from its inception in 1978 as an industrial enzymes company to a fully integrated biopharmaceutical enterprise encompassing a portfolio of products and services with research focus on diabetes, oncology and auto-immune disease. During this transition, Biocon established two subsidiaries Syngene and Clinigene. In recent times, regulators have adopted an inflexibly defensive mindset and seem to be looking for that perfect pill that scores a 100 on efficacy and a zero on side effects. As regulators keep raising the bar for approval, the drug pipeline is diminishing to a trickle, even while discovery research and drug development is gathering pace. On one hand, pharmaceutical companies are battling escalating costs, extended time to market, and a high failure rate in this risk-averse regulatory climate. On the other hand, the medical needs of millions across the world remain unmet. Even when a drug is approved, healthcare systems do not support it unless pharma companies can rationalize the risk-benefit ratio to patients to an extent that justifies the drug’s high cost. To get an idea of what it takes to develop a new drug, we need to consider the rocketing costs in terms of both time and money. A study by the Tufts Center on the study of drug development puts the average time and cost taken to develop a drug at eight years and anywhere between $1.2-2 billion. If a new drug merely shows incremental benefits, as many drugs do, it fails the test of “acceptable risk-benefit profile” and healthcare systems may not reimburse insurers. Thus, patients who need the drug the most, do not get access. It is only when a drug fulfills a hitherto unmet need such as Yervoy (Ipilimumab), the first agent ever proven to improve survival in advanced metastatic melanoma, that the drug can end up on the right side of the risk-benefit ratio desired by regulators and command a premium price from healthcare systems and insurers. In this risk-averse environment, we need to address the regulatory challenge in an innovative way. We need to pursue regulatory innovation that acts as the catalyst for ensuring that novel drugs, based on scientific advances, reach patients quickly. We need an approach that helps pharma companies reduce the cost of drug development and recover the cost of innovation, while providing access to patients who will benefit from such novel therapeutics at acceptable cost. I believe that developing and incorporating biomarkers and companion diagnostics in the drug development process can help us attain these objectives. Companion diagnostics – the use of genetic, proteomic, or gene markers – can help pharma companies develop and deliver more effective and personalized medicines at a lower cost. We can leverage bio-markers and companion diagnostics at the clinical trials stage, screening patients to guard against accepting subjects who may increase the drug’s risk profile and selectively including those who can benefit. Selecting high responders in a drug trial can help reduce the trial size, enhance the trial outcome, contain costs, and, create a better reimbursement model. A pharma company can add clinical markers in the clinical design that address risks upfront – say microvascular or renal biomarkers in a diabetes drug trial – to admit or exclude certain patients. The patients enrolled in the trial are, therefore, likely to show better response with reduced side effects, and since the tailored treatment allows a better view of the outcome, fewer patients may need to be included for the trial. When the safety risk is lowered in this manner and the efficacy profile enhanced, the outcome of the trial can be statistically significant through the extraction of augmented data. Given the reluctance of health systems in reimbursing high-priced drugs that provide only marginal benefit, such strong data can provide a much stronger risk-benefit rationale. Combining drug development with a companion diagnostic, I believe, will help to lower regulatory hurdles and speed up the process. For instance, most recently, the USFDA gave a swift nod – in just over three months – to Roche’s Zelboraf (vemurafenib), when it was presented for approval with its companion BRAF V600 mutation test. Compare this with approval challenges that many cancer drugs face from clinical data drawn from enrolling “all comers”, something that most companies prefer to do to increase the market opportunity but fail in terms of statistical outcomes. Not only does such an approach reduce the size and cost of regulatory clinical trials, it also enables insurers to reimburse healthcare providers for the treatment. Take Herceptin as a case in point. When it was proven through its companion diagnostic that HER2-positive breast cancer patients responded better to Herceptin, the drug was targeted at only such patients and won both regulatory approval and reimbursement support from healthcare systems. With the deployment of companion diagnostics gaining traction, pharmaceutical companies need to develop their proprietary diagnostic tools in tandem with drug development. Such a strategy will allow the company to own the tool’s intellectual property (IP) and will pay significant dividend in terms of speedier regulatory approval, increased market penetration and enhanced revenue whilst also protecting the IP of the drug itself. When pharma companies are unable to stratify and select suitable patients, a drug under trial can show a risk profile that is unfairly attributable to it. Companion diagnostics can help pharma companies assess risk in a more meaningful way and ensure that drugs can be made speedily accessible and more affordable to patients. ]]> <![CDATA[Quality at an affordable price is a challenge]]> https://biospectrumindia.com/news/95/3786/quality-at-an-affordable-price-is-a-challenge.html https://biospectrumindia.com/news/95/3786/quality-at-an-affordable-price-is-a-challenge.html Tue, 11 Oct 2011 11:33:00 +0530 Dr SD Ravetkar Senior director, Serum Institute of India The author has been with Serum institute of India since its inception. He has 38 years of experience in the biotechnology industry’s various aspects, like production, QC, projects and R&D. He has also chaired the Innovation Panel of Confederation of Indian Industry, Pune Chapter. The rapid acceptance and unexpected commercial success of Prevnar and Gardasil changed the vaccine market scenario around the world. Following this, pandemic flu threats created awareness among people about primary prevention of infectious diseases. Also, the government authorities in the developing countries have become more proactive in satisfying the unmet needs of vaccines, which incidentally have the highest demand in the world. However, because of low affordability in this population and high prices, people were deprived of the benefits of high innovative vaccines. Challenges before companies A major challenge before biotechnology companies, in terms of marketing, has been manufacturing quality vaccines at affordable prices. Highest standards required for manufacturing and long gestation period from table to market fueled with very high capital costs and clinical trial costs make this task very challenging. Availability of technology is a major issue. Conducting basic research and developing technology is a barrier for vaccine developments as they affect the cost of vaccines. People talk about a worldwide vaccine market of around $20 billion. These figures are based on ruling prices in the US and the EU. With developing countries having a successful track record of selling new innovative vaccines at 1/8th the price, the market becomes much smaller in terms of value. One outcome in the last decade has been the increased number of manufacturers, which has put a lot of pressure on price. This is good news for the common man who has more choices and affordable drugs, but the same has become a challenge for the biotech companies. In the developing world, particularly in India, most companies try to imitate than innovate. We need more of Dendreon-like success stories where the company is predicted to achieve revenue of $3 billion from the sale of one product. Biotech companies need to educate and convince people about weighing the dangers of contracting diseases versus risks, associated with immunization. The swine flu outbreak was a classic example where people did not understand the fatal nature of the disease and preferred to volunteer to contract the disease than get vaccinated. Despite India becoming the hub of vaccine manufacturing, the government is still silent about the use of newer vaccines. Bureaucrats are still debating the need of the vaccines than trying to study the world scenario and learning from the experiences of other countries. ]]> <![CDATA[Need awareness to tackle misinformation]]> https://biospectrumindia.com/news/95/1448/need-awareness-to-tackle-misinformation.html https://biospectrumindia.com/news/95/1448/need-awareness-to-tackle-misinformation.html Tue, 11 Oct 2011 11:32:00 +0530 Dr Usha Zehr Chief technical officer and joint director of research, Mahyco An expert geneticist, Dr Zehr has been the brain behind the development of Bt brinjal at Mahyco. She serves on a number of boards, including the MS Swaminathan Research Foundation and the Mahyco Research Foundation, and is a member of the technical advisory committee of the consultative group on International Agricultural Research. The Indian economy is booming and so is the biotech sector. The country witnessed reasonable growth in biotechnology over the past few years and has the potential to grow significantly in the coming years. The agriculture biotechnology sector has seen growth as a result of the cotton technologies, basic research and diagnostic tools developed, but pharma biotechnology has seen a much stronger growth. Potential for agriculture biotechnology is equally good. Many new products are at their final stages of development and regulatory approvals. India is ranked among the top 12 biotechnology destinations worldwide and is the third largest in the Asia-Pacific region. The biotechnology sector grew by 21.5 percent in 2010-11 to cross the $4 billion mark, as revealed by an annual survey conducted by BioSpectrum and The Association of Biotechnology Led Enterprises (ABLE). It is interesting to note that most of the companies operating in the biotech sector today are largely dominated by private players. The agri-biotech sector has also been dominated by products from the private sector. Given India’s scientific talent pool, resources and basic infrastructure, the opportunity for improving our global potential is big.  Among the various challenges faced by the biotech sector, those related to marketing challenges are critical, which have to be identified and addressed at different levels, to enable smooth flow of products and services to the target audience at the right time and right place. The biggest challenge of developing an agri-biotech product, to be planted in the fields, is the time taken to develop it. India has a stringent regulation in place for biotech products. The current system for product development can take more than 10 years. The introduction of Bollgard and Bollgard II was an excellent learning in terms of what was needed for a biotech product introduction as compared to what we had been doing since the beginning of the seed industry. The key challenges for the industry are: Creating awareness about biotech products, which will include extension activities. Tackling misinformation spread due to lack of knowledge or by vested interests. Awareness building with various stakeholder groups. Understanding the need for use of biotechnology. Ensuring that the policy environment facilitating product development processes is efficient. Managing farmer expectations with regard to agri-biotech products. Given the long time it takes to develop a genetically modified (GM) product, it is critical that the regulatory approval process established is rigorous and timely. The Biotechnology Regulatory Authority of India Bill (BRAI), currently under discussion, aims to provide a single-window facility for clearance of biotech products. The agri-biotech industry welcomes regulations that will enable timely examination and approval of products for the benefit of the agricultural community. Since biotech products, particularly GM products, are relatively less understood, the key challenge is creating better understanding and credibility at the initial stage. India’s agriculture has been able to keep up with the demands on food grains and it has been supplemented by imports as needed, particularly in pulses and oils. However, as we look to the future requirements and our diminishing resources of land, water and potential impacts due to climate change, we need to be looking at tools for addressing the demand. Creating this awareness is critical to the future of biotech products. Communication is the urgent need Biotech product development is a complex process. This requires extensive explanation of product features, action and benefits before customers fully understand the need for them. When connected with a sensitive industry like biotechnology, it becomes extremely important to build credibility and convey facts. Typically, scientists have not been engaged in communication activities but this is very much needed to engage various stakeholders. Mahyco has been marketing seeds since 1964 and enjoys farmers’ trust, for which we are grateful for.  The biotech products challenge us to improve our communication and also the stakeholders that we need to engage with. Traditionally, our communication was primarily restricted to the farming community directly. With biotech products, the stakeholder groups are not just farmers, but include consumer groups, students and policy makers, and the communication needs have to be fit for the respective groups. At Mahyco, we dedicate our efforts to educate the stakeholders via direct outreach, thus, making an effort to communicate the company’s message in a simplified manner. Our marketing messages focus on the challenges faced by India’s agriculture, the farmer and what solutions are possible and how biotechnology tools will play a key role in that. Overcoming each of these phases has been a rich learning experience that has helped us develop world-class expertise in biotechnology. Biotech products require a distinctly different kind of marketing. It is important to recognize the unique place that these cutting-edge products have in the marketplace and appreciate the changes they can bring about in the country. Successful launch of these products will bring tremendous benefits to farmers, consumers and the nation as a whole. ]]> <![CDATA[Customer relationships in a competitive market]]> https://biospectrumindia.com/news/95/5588/customer-relationships-in-a-competitive-market.html https://biospectrumindia.com/news/95/5588/customer-relationships-in-a-competitive-market.html Tue, 11 Oct 2011 11:31:00 +0530 Dr Manu Jaggi Director, Dabur Research Foundation The author holds a doctorate in cancer biology from the National Institute of Immunology and is a postgraduate in pharmaceutical sciences. He has more than 20 years of research experience in new drug discovery and early and advanced preclinical drug development. He is currently the director of Dabur Research Foundation, a preclinical CRO. The pharmaceutical industry, which is recovering from an economic downturn, is now undergoing significant changes ranging from drug development philosophy and tightening of regulations to restructuring, consolidation, and mergers and acquisitions. These changes are impacting the contract research organizations (CROs) and the services that they provide, from where, and to whom. The drop in R&D spending during the last few months is beginning to take its toll on preclinical CROs, which are experiencing heavy discounting, delays, and cancellations. These changes may, however, present some opportunities for CROs. Although R&D spend has been down, many in the industry believe that outsourcing will inevitably rise in the near future. Preclinical CROs face situations that are as challenging as those faced by pharmaceutical and biotechnology companies but with additional unique challenges. In this service-based industry, managing customer relationships is especially important. Staying at the forefront of cutting edge technology is crucial, and the service portfolio of a CRO must adapt to utilize new tools and maintain a state-of-the-art offering of services and capabilities to customers. Contract research organizations must also make their clients comfortable to entrust them with the responsibility of conducting a study. At the same time, CROs face pricing pressures and competitive marketplaces, just like companies developing the products. In the current scenario, Dabur Research Foundation has taken six key initiatives to differentiate itself from the others. Strategic partnership with other CROs Rather than being the small fish in a big pond, emerging firms are actively elevating their status by testing the waters of strategic partnerships with other CROs. In an article in BioSpectrum this year, titled ‘The Year of Consolidation & Collaboration: CROs to see big boom’, I mentioned that many CROs and pharmaceutical companies are turning to strategic partnerships to gain a competitive edge in the global business environment. Various business models are being employed to forge long-term relationships. Consolidation of businesses has turned from a trend to reality. The CRO market, which is highly fragmented today, will see further consolidation in 2012 where small and large CROs will continue to merge. Dabur Research Foundation now has strategic partnerships with other Indian CROs that enable a broader service offering to clients. Such partnerships are a win-win situation for both clients and the CROs. Customization of services A smaller CRO has the ability to tailor its services to the specific needs of the sponsor. This has the added benefit of building trust since the sponsor doesn’t feel nickel-and-dimed. Dabur Research Foundation recognizes the need for outside the box thinking to enable rapid and cost-effective preclinical development of molecules for its valued clients. We take pride in the fact that we go beyond being a service provider and partner with our clients during the entire drug development process. To facilitate this, Dabur Research Foundation has a unique central innovation research team (CIRT) that develops novel or hard to do in vitro, ex vivo and in vivo disease models required for specific client projects. The CIRT comprises talented researchers who take responsibility for development, validation and successful transfer of new models to the study teams. Gaining entry in new geographies While it is imperative to expand the geographical reach of the business, it is virtually impossible to set up offices and hire business development personnel in each of the important geographies. Several countries have not-for-profit organizations that have a mandate of helping those interested in exploring market opportunities, provide in-depth information on key industries and offer guidance for setting up business in their countries. Majority of such organizations are located in important biotech hubs with a cluster of small and large pharmaceutical and biotechnology companies operating in diverse therapeutic areas. With an aim to promote the region internationally while attracting and maintaining foreign companies, entering a new geography with the help of such organizations is a very attractive route before one makes larger financial commitments. Do more with your website Your website should be your most effective marketing tool for lead generation. Besides putting details of your services on the website, conversation opportunities are being increasingly employed by CROs today to increase visibility and attract business. Newsletter, notifications, opportunity to download documents and reports, encouraging prospects to email with questions, and options for online instant messaging are being seen on many websites. Many also link blogs to websites. People want to be educated these days, not sold. Blogging helps to position yourself as an expert in your field. Also, linking your blog to the website helps increase the likelihood of your site moving up in search engine rankings. Partnering meetings Personal interaction with contacts, at conferences, trade shows, congresses, and through presentations is an old and time tested way of effective marketing. Partnering meetings give an opportunity to connect with a growing community of potential partners. It’s an ideal forum for meeting people with expertise in research, manufacturing, materials, regulations, licensing, financing, or intellectual property rights. Deals that may otherwise seem very complex to consummate and take several weeks or months get expedited since such meetings help you to set appointments with the decision makers. Use online marketplace While it is important to have a broad-based service portfolio, it is no good if potential clients are not aware of the services. There are several online marketplaces for drug discovery and research services. Researchers are increasingly using this marketplace to find, compare and purchase research services and to request information from thousands of contract research organizations. Dabur Research Foundation uses this marketplace to offer services and products to the global research community. What doesn’t work With ready availability of advanced software solutions and hosted services, launching a mass email campaign has become easier than ever before. Mass email is a powerful vehicle that gives you the opportunity to market new products and services to a global audience of potential customers. However, there is a very fine line between genuine email marketing and spam and several surveys have shown that such mails are treated much the same way one treats pesky SMSes today. Great technical skill-set but a poor representation of business has been the bane for many CROs. Clients are no longer satisfied by just meeting the business development manager who has great business sense but knows little about the technical aspects of the study being discussed. Decisions about outsourcing are increasingly been taken by senior scientists today and they want to meet people who understand science and can make them comfortable outsourcing their precious studies. ]]> <![CDATA[Going beyond low-cost CRO stereotype]]> https://biospectrumindia.com/news/95/1658/going-beyond-low-cost-cro-stereotype.html https://biospectrumindia.com/news/95/1658/going-beyond-low-cost-cro-stereotype.html Tue, 11 Oct 2011 11:30:00 +0530 Mr CSN Murthy CEO, Aurigene Discovery Technologies Mr CSN Murthy is a chemical engineer from IIT, Madras, and an MBA from IIM, Bangalore. He started his career with ICICI Ventures and has worked for over 12 years in the pharma industry. He has, since 2005, been the CEO of Aurigene Discovery Technologies, which is a subsidiary of Dr Reddy’s Laboratories. The pharmaceutical industry has, for long, depended on external sources of innovation, and, by some measures, about 40 percent of the overall portfolio of drug candidates are generated by biotechnology companies and licensed by pharma companies. This gives rise to a large market for innovation with pharma companies on the lookout for new medicines, and young biotech companies, which do not have the resources or the experience to take new drugs all the way to the market on their own, reaching out to market their early-stage drug candidates to suitable development partners. However, as in case with all innovation, and more so in the case of the pharma industry, the financial and scientific risks of drug development are very high. Thus, commercialization of drug discovery and development needs a lot of planning and strategic execution, together with strategies in place for risk-mitigation. Asia has unique advantages in terms of availability of a large patient pool availability, cost-efficient means to drive drug discovery and development, and availability of a large and talented work force that is just beginning to enter this area of science. Drug discovery industry in India Many companies in India have entered the pharmaceutical industry through the generics route. Known and approved drugs have been manufactured in cost-effective ways, and the generics industry has not only benefited the Indian consumer, but has also contributed significantly to the global generics needs. The next few years will also provide big opportunities for growth in the US and European markets, with innovator companies poised at the edge of the so-called patent cliff between now and 2015. In the face of such large opportunities in the generics’ space, pharma companies in India have naturally focused in this space for their growth. Concurrently, the domestic pharma market has provided significant opportunities for growth too. However, the margins in the generics space do not match with the margins that typically integrated innovator pharma companies generate. As a consequence of these circumstances, less-than-optimal investments have been made in drug discovery by pharma companies in India. Even companies that have invested in this space have typically committed no more than one-to-two percent of their revenues in drug discovery and development as compared to an average of 15 percent or more, which typical innovator companies invest in R&D in the US or Europe. Consequently, successes of companies that have out-licensed their compounds, such as Glenmark, are exceptions rather than the norm. As investors looked at the biotech space, not surprisingly in the land that has traditions of IT services and BPO companies demonstrating huge growth and promise, many investments went into providing “services” to innovator companies. Thus, we have a landscape defined by generic companies with occasional and apologetic investments in drug discovery and development on the one side, and a few services companies that have not scaled enough to be considered large or world-class by standards that are generally applied in this space. In this landscape, juxtapose the few stragglers who have attempted innovation and are looking to create opportunities for their drugs under development, and we will begin to see where the marketing challenges appear before biotech companies. The marketing challenges Most innovator companies, when they think of India, see the prospect of an alluring and growing market for their products, with their own domestic markets in Europe and the US either being static or shrinking. A few companies also look towards India, primarily as a source of low-cost services due to given India’s strong track record in chemistry and manufacturing. Seldom have innovator companies looked to India as a source of innovative drugs. Thus, a typical biotech company from India has to overcome the tag of a “CRO” (a synonym for a low-cost provider of services) first, before addressing other endemic challenges of lack of an ecosystem for innovation in drug discovery, a small (though growing) pool of scientific talent and experience, and a regulatory environment that is certainly not a role model to even the most generous critic. Mitigating challenges Biotech companies certainly need to invent in India in forms that make them relevant and attractive to pharma companies seeking innovation in India. Consistency in terms of communicating their focus as a biotech (as opposed to a cost-arbitrage business), sustained visibility in the appropriate forums where pharma companies look to source innovation, publishing data from their innovation at appropriate and opportune moments, and consistently collaborating with scientific leaders in their areas of innovation could together result in providing the appropriate positioning for biotech companies. Emphasis on the value proposition that the location in India provides, not necessarily in terms of low costs (a potent weapon in the hands of the buyer, not the seller of innovation), but also from other perspectives, could bring the visibility needed in a competitive marketplace. Use the ‘India advantage’ Biotech companies face steep challenges in setting up and positioning their intellectual property in a market that is known more for providing cost arbitrage opportunities than for delivering high-quality innovation. However, examples of companies that have successfully navigated the marketplace in India should provide biotechs in India clues on positioning themselves to stay relevant and generate value that only innovation can bring. This needs biotechs to clearly use the “India advantage” appropriately in their positioning in the marketplace, while moving consciously away from the stereotype of the low-cost CROs. A conscious communication strategy, backed by relevant linkages with experts, high-quality publications and marketplaces for innovation, will see some of the emerging biotech companies excelling and prompting more investments into this space in the time to come. ]]> <![CDATA[Promotion among prospective farmers]]> https://biospectrumindia.com/news/95/1068/promotion-among-prospective-farmers.html https://biospectrumindia.com/news/95/1068/promotion-among-prospective-farmers.html Tue, 11 Oct 2011 11:28:00 +0530 Mr M M Saoji Director, marketing, Ankur Seeds, Nagpur The author has experience of three decades with Ankur Seeds. He successfully conceptualized and established many products in cotton, field crops and vegetables. Presently, Ankur Seeds is operational in 20 states of the country. His customer insight and focus on brand pull has enabled the company to reach a new zenith. The life sciences industry is one of the most interesting and challenging industries in the world today, because of its vibrancy and solution-providing potential. However, there is an inherent challenge for corporate leaders in the life science companies to exude confidence in their processes and product-development capabilities, while remaining true to the complexity of what it takes to develop a product, survive lengthy clinical and field trials, and bring it to market. Marketing in biotechnology needs to foster objectivity, report facts and steer clear of hype. Truth needs to be communicated to both, the stakeholders and the public. Industry background Among all the divisions of biotechnology, bioagri has huge potential as we have already witnessed that “Indian farmers are the world’s fastest adopters of Bt cotton technology”, owing to the immense benefit associated with it. Today, India has got the highest area under Bt cotton in the world (98 percent of the total cotton in India is Bt cotton). As a result, cotton has become the biggest success story in Indian agriculture since the Green Revolution. In a country struggling with stagnant yields in most crops, cotton has been the one exception. Production soared from 13.6 million bales in 2002-03 to 31.2 million bales in 2010-11, a figure that catapulted India into the big league, enabling it to account for as much as 23 percent of the global production in 2010 and a significant chunk of the forex earnings through the export of cotton yarn. Bt cotton technology adoption success can be compared with information technology and mobile technology, but when we consider the end user profile, the success dimension of Bt cotton becomes even more significant. Thus, without any iota of doubt, we can say that bioagri is going to play a key role in shaping India’s rapidly developing rural economy in the coming years. This is evident from the growth rate of bioagri, which has been the highest among all the biotech segments since the last four-to-five years. Challenges of patent protection Considering the huge investment required in developing new biotech agri products, the seed industry has been waiting eagerly to have an effective product patent act in place from the concerned authority to motivate the companies to make investments in order to innovate and develop newer, better products for early release in the market. Production planning Bt cotton seed production planning is a very complex activity as it has to be planned one year in advance at the corporate level and all the risk associated with it are to be faced by the company itself. Over and above all, production quantum has to be estimated before seeing the actual product performance in the field. Acreage under cotton crop depends upon commodity rates of the produce and crop economics of substitute crop. Thus, estimating the actual demand of product are dependent on some uncontrollable factors. Similarly, cotton seeds are produced in open field conditions and are exposed to weather vagaries. All these factors make it very difficult to match the actual market demand as a result of which, sometimes, we end up with excess supply and some other times, with short supply. As seeds are perishable goods, accurate forecasting of the particular product is of immense significance. Capital funding With the advent of Bt cotton in India, stake of Indian seed companies in this business has increased manifold. The higher cost of production has put a lot of pressure on the financials of the seed company. However, none of the channel members, being unorganized, share the financial burden so that the company can free some money from the working capital to invest in future projects in order to support R&D, initiate and sustain new projects in the bioagri field. Technology harvest Seed companies dealing with biotech products are not done with their jobs until and unless they provide after-sales service to existing customers for harvesting maximum leverage out of biotech products and enabling these companies to show their real worth through propagation of certain cultivation practices such as, proper spacing, balanced use of fertilizers and micronutrients in split doses, irrigation at critical stages, spray of appropriate pesticide for control of sucking pest and understanding of the economic threshold limit concept. This technology communication is being done by Ankur seeds at its own level very piously by looking into the benefit arising out of the agriculture extension wing of the government could help in propagating the same with brisk pace.  Technology dissemination We understand that in the seed business, we are required to potray successfully-raised crops to the prospective farmers, since ‘seeing is believing’. It is the best means to propagate the new technology but it is also a costly means of promotion. Thus, government support is solicited in further promotion of the technology among non-users. Government regulatory structure Taking into account the huge success of Bt Cotton, Indian farmers are expecting further advanced products in seeds with the potential to mitigate their misery through reduced cost of cultivation and increased production. Different agri-biotech projects are in pipeline with different seed companies like, herbicide resistance in cotton, drought tolerance in cotton, sucking pest resistance in rice and cotton, herbicide resistance in corn and cotton, and uniform boll bursting in cotton. However, these are not able to reach farmers because of complex government clearance system. Streamlining India’s regulatory framework through the inception of a single window product clearance system with well-defined parameters in the biopharma sector, wherein certain set of clinical trials for a specified period are required for the release of vaccine or medicine, has to be put into place. ]]> <![CDATA[Deeper understanding of client needs]]> https://biospectrumindia.com/news/95/2488/deeper-understanding-of-client-needs.html https://biospectrumindia.com/news/95/2488/deeper-understanding-of-client-needs.html Tue, 11 Oct 2011 11:27:00 +0530 Mr Pankaj Sharma CEO and co-founder, LeadInvent Technologies The author is a biotechnologist and a computer scientist. He worked at IIT Delhi, where he developed simulation algorithms for biological systems. He is the CEO and co-founder of LeadInvent Technologies that was awarded the Asia Pacific Emerging Company of the Year 2011 Award by BioSpectrum. Biotechnology in particular, and life sciences studies in general, provide an ideal field for ground breaking innovation and discoveries because much less is known about biology when compared with some of our other mature scientific pursuits. Biology seems to be far ahead than our current understanding of it. After all, life has more than three billion years’ of head start over us. And it is in this attempt of understanding and interaction with biological systems lies our greatest promise. One such long-standing quest has been in the area of understanding diseases at the cellular level and trying to come up with solutions to fix them. A disease is nothing but an end point observation of multiple small events that go wrong inside the body. The only way to deal with such a situation is to deconstruct a disease into a meaningful scientific quest. There are multiple approaches that could enable us to do this. One such approach is popularly known as computational biology that literally translates to computer simulations of biological systems. At the core of this discipline is our ability to study protein molecules and their interaction with small molecules. Computational biology receives a somewhat mixed reaction. One school of thought completely ridicules its usage with generalization that computers don’t give drugs. The other, somewhat curious, attempted the logic between computer simulation and their correlation to experimental results. The accuracy of such simulation predictions versus experimental results has always been debated. Both disciplines have made considerable progress over the last two decades. Our experimental techniques have advanced with newer methods: from PCRs for reading whole genome to micro arrays. Miniaturization and automation of assays have allowed experimentalists to evaluate millions of compounds with unmatched ease and accuracy. The newer advances have also created challenges of their own. Our genomics’ scientists are able to read terabytes of data within a short span of time, but are grappling with challenges of assembling such huge data and interpreting key insights. Techniques using ultra fast X-ray spectroscopy hold the promise to truly understand different conformations of protein molecule samples but remains in development. Our Förster resonance energy transfer (FRET)-based assays are allowing accurate understanding of interacting molecules but requires more standardizations than those, which are currently available in the market. Computer hardware has consistently caught up with Moor’s law leading to doubling computational capabilities of chips every 18 months. We are now at a point where the fastest supercomputer in the world can compute more than eight quadrillion calculations per second (petaflop/s). This is serious computing by any dimension and reminds me of how far the computate capabilities have reached from the early days of 2002 when our team was building the first dedicated supercomputer for computational biology at IIT Delhi. The challenge, however, is for computational biologists to capitalize this opportunity and make use of such compute power. One of the key advantages that simulations provide is the ability to understand our biological system at the atomic level. The world seems to operate on two fundamental levels. One that is beautifully and intuitively explained through Newton’s equations, popularly known as classical mechanics or molecular mechanics, and the other more fundamental, known as quantum mechanics. The challenge for computational techniques is to walk the fine line between these two worlds and balance the approximations within the details of the study. The most important step in understanding a problem is formulation of the right question. This should be followed by setting up simulation protocol within the framework of available compute resources and simulation technology capabilities. The right start in this direction stems from collaboration between the experimental team and the computational team. At LeadInvent, our greatest learning curve has been working with experimentalists. In our observation, when simulation answers start guiding experimental effort, that’s when the true realization of molecule simulations effort is felt. Edge over others LeadInvent has gone through a transition as a company. The company was started purely as a bioinformatics company with a business plan to package its simulation technologies as products and eventually sell them as standalone application in the drug discovery market. We quickly realized that the targeted industry’s challenges were far deeper in demands of drug discovery than unavailability of appropriate bioinformatics tools. LeadInvent metamorphosed and we started working more closely with experimental teams on our client side. Framing the right simulation questions and providing simulation feedback were key to our engagement with clients. This gave LeadInvent the market edge over others. Meanwhile, we collaborated extensively with top notch academic centers, such as the All India Institute of Medical Sciences, Delhi University, the Indian Institutes of Technology, Tata Institute of Fundamental Research and Harvard Medical School for broadening our overall knowledge and capabilities in experimental science for specific projects. We generated support from the Department of Biotechnology under the small business innovation research Initiative programs and invested in upgrading missing links in technology and ensuring that the technology was in tune with experimentalist requirements. The benefit has been felt on both the sides. While our partners have had access to LeadInvents team, technology and computational platform as one billable resource, LeadInvent got the opportunity to re-evaluate how best to apply its simulation technologies in drug discovery pursuit. The question again appears before us. Is it safe to say that the recent development in computational biology coupled with newer computing platform is ushering renewed interest in simulation results? And, are we close to making an opinion for the selected few who generalize that computer’s don’t give drugs? I guess the greater knowledge is in our understanding that computational biology plays a pivotal role when coupled with experimental team in pursuit of right questions. There is definitely no single technology that could alone give rise to drugs. Why than generalize it for computational biology? After all, more than 55 drug candidates were recently reported in a review to have benefited from computational biology approaches. It’s not the technology that is at the heart of drug discovery, it’s the team. After all it’s not the rocket that puts a man on the moon, it’s the people. The challenges for any computational biology company are many. The underlying technology is definitely a place to start with, followed by constant revaluation in this era of computing growth and experiment. ]]> <![CDATA[Understand products in order to market them]]> https://biospectrumindia.com/news/95/1625/understand-products-in-order-to-market-them.html https://biospectrumindia.com/news/95/1625/understand-products-in-order-to-market-them.html Tue, 11 Oct 2011 11:26:00 +0530 Mr Rajeev Kumria General manager, business development, Transasia Bio-Medicals The author is responsible for foray into new immunoassay projects and mergers & acquisitions at Transasia Biomedical. He has previously worked with Bharat Serums and Vaccines and Advy Chemical. He holds a master’s degree in biotechnology from the Center for Biotechnology, JNU, Delhi, and a postgraduate diploma in marketing management from IGNOU, New Delhi. Biotechnology is a vast and diverse field and the complexity of biotech marketing in India is further heightened because of cultural and infrastructural issues. Revenue of the biotechnology industry in India touched $4 billion in 2010-11, witnessing a growth of approximately 22 percent. The biotech sector is a young industry and it is already ranked the 12th-most lucrative sector in the world. With the spectacular growth comes a deeper understanding of the challenges ahead. These challenges become an impediment in the growth of the industry and delays commercialization of products. The challenges of marketing in the biotech sector are very different from the challenges in other industries. Many times, it is the lack of understanding on the part of the end user for whom the product or the solution is developed or designed. In the mature markets too, there is a debate and lack of understanding on the part of marketers on ways to handle the more complex biotech products. The gap between the product makers and marketers leads to rejection of product, sometimes with repercussions that can lead to perfectly good products being rejected. A more detailed segmentation of the industry will lead to unique issues and challenges. Segment End user Product type Key challenge Life sciences Scientists at pharma companies and university research institutes Biologicals, instruments, chemicals Diversity of product range, lack of information on consumption and research area Agri Farmers Seeds, biofertilizers Knowledge and understanding gap Biopharma Patients Recombinant therapeutics, monoclonals anti cancer agents, biomarkers Safety of products, gaps in understanding as these are new age products Industrial/Environmental Industries, corporations Enzymes Process change expense, return on investment understanding, economics The very young nature of the industry is throwing a huge challenge before the regulatory bodies to institute changes in the regulations to support faster launch of products, while taking into account extensive long-term safety profiles and socio-economic impacts. Also, the issue with the biotech sector is that start-ups are founded by scientists and their appreciation for marketing comes very late during the day. Furthermore, the issue gets more complex as most of the innovations are coming from start-ups and these companies have high costs and risks. By the time a product reaches beyond mid phase of development, the pressure on commercialization is very high and, although marketing is the most important activity that should start early, it is generally not introduced until late in the day. Addressing the issues The complexity of the industry presents complex challenges never encountered by society and the biotech fraternity. Among the steps that can be taken to address the issues is creating forums or portals to disseminate information at different levels. At the level of industry, information exchange platforms are needed for connecting different stakeholders and, at the company level, more educational and information channels are needed. These could be portals with information on research and activities to assist life sciences marketers and users, and segmental portals with information on products and services. More understanding and expenditure by companies is required in reaching out to consumers. There should also be bodies to assist young start-ups in understanding and providing cost-effective marketing platforms. Neutral platforms and forums, which provide a balanced view of products and services, are also important. This is needed to avoid bad media coverage and generating a balanced view of opportunities and risks among people. Special cells are needed in regulatory agencies to deal with biotech products. A lack of understanding and old dogmas about biopharma and bioagriculture can act as roadblocks for the industry. More than understanding, the speed of response is important, considering the dynamism of the industry. ]]> <![CDATA[Funds for high-risk, long gestation projects]]> https://biospectrumindia.com/news/95/2220/funds-for-high-risk-long-gestation-projects.html https://biospectrumindia.com/news/95/2220/funds-for-high-risk-long-gestation-projects.html Tue, 11 Oct 2011 11:25:00 +0530 Mr Rajeev Sindhi CEO & MD, Sandor Proteomics The author is a first generation technocrat businessman. His career started with setting up a 100 percent export-oriented granite manufacturing plant 21 years ago. He ventured into medical business in 1996 and has since been in the healthcare and life sciences industry. He is presently the CEO and managing director for Sandor Proteomics. The mission of our start-up biomedical research laboratory was to discover novel biomarkers in the field of transplantation, infectious and immunological diseases. Our chief scientific officer initiated this process in at least one of these therapeutic areas in the US. The laboratory in India would expand research testing to additional subjects, and expedite the development process while validating potential biomarkers in the Indian population. However, our financial model suggested that, as a small enterprise, we had to have many independent, though synergetic, revenue streams to ensure steady cash flow, while fulfilling our discovery agenda. This prompted us to create a parallel service model. Additional funding was needed to procure the equipment necessary to offer a range of research services. Early opportunities to provide such services included diagnostics for rare genetic disorders and high throughput genomics. Both opportunities guided formulation of our revenue generation strategies for the near to medium term.  To pursue these expanded goals, we began to search for an investor who could partner in a high-risk, long-gestation project. We were extremely fortunate to have an investor in Mr Shapoorji Pallonji Mistry, who shared our vision. Since inception, we have struggled with a constantly evolving business model focussed largely towards ensuring sustainable revenue streams. The government, though very promising on paper, hardly matched the risk appetite needs of a discovery company. Regular funding applications to various government agencies became a norm even though the success rates were very low and the process painstaking. At least one funding agency, the DBT, did guide us towards success in achieving competitive SBIRI funding to fulfil our discovery research goals. Once awarded, our annual dialogue with the DBT reviewers and scientific auditors has been the one bright spot and a highly anticipated interaction in our ongoing search for governmental support. Their willingness to understand commercial scientific and technical ground realities, and provide suggestions has been very helpful.   Our plan to enter the long-gestation business of diagnostics for rare metabolic disorders was finalised, while associating with paediatric geneticists in India. All of these practitioners were being supplied with life saving enzyme therapies by Genzyme Corporation, US, under Genzyme’s charitable access program. Our sister company, Sandor Medicaids, was the distribution conduit for these supplies. It was the urgent need identified by these physicians that prompted us to initiate a technology transfer and training contract with Erasmus Medical Center, Holland. A diagnostic lab for metabolic disorders was established. With support from Erasmus and geneticists who believed in the quality systems’ implemented in our laboratory, we began testing patient samples that had historically been shipped out for overseas testing. At about this time, the company also took a bold step to install the first-ever high throughput genomics platform from Illumina, US, in the private sector. Although extremely expensive for a start-up, this platform gave us a unique edge as the first private sector high-throughput genotyping service provider in India. As a result, one of the largest genome-wide association study (GWAS) in India was outsourced to us by a government institute. Subsequently, we started offering next generation sequencing. We were fortunate to get the first large contract for de novo sequencing of the Indian buffalo along with early contracts for transcriptome analysis from an Indian Council of Agriculture Research (ICAR). Today, our company is the sole certified service provider for Illumina for their genotyping and gene expression services in India. As the first private sector service provider of this technology, we would not have succeeded without the excellent and continuous technical and scientific support of Premas Biotech, who represented Illumina in India.    Our association with the animal genetic institutes of the ICAR prompted us to look at opportunities in animal sciences. We established a separate laboratory for animal genetics for diagnosis and research. In a country like India, where animal husbandry has a major role in agriculture, we believe that there is sufficient promise in this business. Another opportunity presented itself when the head of a government institute decided to experiment with a public-private partnership (PPP) model to run their central instrumentation facility (CIF). We competed successfully for an open tender to accomplish this objective. A successful PPP model has been developed. Management of a well-equipped central facility gives us access to some of the latest and more expensive biotech research instrumentation at a reasonable access price. The government institute has gained trained manpower to operate their instruments and recover instrument costs. Today, in our fourth year of existence, we have created a niche for our company in the field of animal genetics, created a bio repository for biological samples, and successfully run a PPP model of handling CIF for government-owned central laboratories. We offer high throughput genomic and proteomic services to scientists. In this process, our company has become a well-respected and sought after referral lab for paediatric geneticists across India. We have fully accepted that our business model will keep evolving in order to capture changing opportunities. Viable revenue streams, in our opinion, will be the basis for sustaining operations. A significant component of these operations is our long-standing in-house discovery programs. We expect these discovery efforts to be complemented by generation and commercialization of shared IPR as a result of collaborative research with various government or private organizations. Although extremely demanding and challenging, our experience has been very educational and satisfying. As a start-up company, attracting talented manpower can be a constant challenge. Ongoing financial and logistical support from our investor-mentor, Mr Shapoorji Pallonji Mistry helped us negotiate these challenges. This ongoing support and access is crucial for any start-up during difficult business cycles. Most importantly, a shared vision with talented staff has been our sustenance. Long hours are required to stay competitive, meet contract deadlines, bid on tenders, or develop novel approaches to organize workflow. None would have been possible without colleagues who undertook every business challenge selflessly for the success of our team. Our sister company, Sandor Medicaids, which distributes and markets high-end niche biotech drugs, devices and equipment for the healthcare industry, has also supported our research and diagnostic initiatives by providing cold chain logistic support throughout India. We are certain that the search for newer business models will continue and result in parallel additions to our research goals. These business models will be driven by unmet market needs both in agriculture and life sciences. Hard work with a lot of good luck will remain the cornerstones of any success in the future. ]]> <![CDATA[Product failure leads to public, investor scrutiny]]> https://biospectrumindia.com/news/95/6007/product-failure-leads-to-public-investor-scrutiny.html https://biospectrumindia.com/news/95/6007/product-failure-leads-to-public-investor-scrutiny.html Tue, 11 Oct 2011 11:24:00 +0530 Mr Sanjeev Saxena Chairman & CEO Actis Biologics The author brings over 22 years of experience in bio-pharmaceutical industry. Mr Saxena founded Actis Biologics in California in 2003 with well-known scientist Dr Dave Toman. Then, he founded Actis Biologics in Mumbai in 2005. He further expanded the group to Malaysia by forming Actis Biologics Malaysia in 2007. He also founded ProGenix Biotech in California and Sepragen Corporation in the US. While the much-awaited economic recovery was a major let down in the last couple of years, it is interesting to note that many biopharmaceutical and biomedical companies reported record-breaking profits in 2010. The current year is expected to be very challenging as a result of patent expiry and impending generic competition from many pharmaceutical and biotechnology companies. This brings about great opportunities for the research-based biotech industry. Big pharma companies have no place to go for innovation, except to acquire smaller companies who have already taken the risk on new drug development. Consolidation has accelerated in the last two years because the capital markets are tough, making M&A an attractive exit strategy for investors. Challenges in marketing Biotechnology companies have their own set of challenges in marketing drugs by themselves. One of the major issues they face is financing. The financing they gather goes into the development of various molecules and, hence, marketing and sales become an issue. Also, the sales and marketing professionals prefer to be employed by more robust and well-established brands and companies, so recruitment is a key issue. There is also pressure from investors to provide quick returns on investments and are unwilling to wait for the length of the product life-cycle. So, the biotech companies are forced to look for partners in the large pharmaceutical companies, though they are no more or no less successful than the pharma giants when it comes to drug development. Presently, it takes 10-to-12 years for a biotech drug to make it to the market. It is also interesting to note that while the industry starts with over 10,000 leads, only about 250 make it to the preclinical stage and only 50 make it to phase I trials, of which only three to four make it to phase III trials. Out of these promising molecules, the industry makes a decision on which drug to take forward into phase III and the market based on market potential, competition and cost of manufacturing. While it is true that most phase III molecules work, the market realities can make a company drop the product from its pipeline. Some of the phase III drugs are then repositioned as was in the case of Viagra, for a different indication. Hence, for biotechnology start-ups, the stakes are extremely high. Large companies have many successful products in the market. A biotechnology company’s continued existence depends on the success of those one or two products. Therefore, failure is much more public and highly scrutinized. It leaves investors and the public with little or no incentive to remain supportive of the company. As a result, business development deals or strategic partnerships have emerged as a vital part of resources that biotech start-ups leverage to become successful. Pharma MNCs are currently confronted with a number of blockbuster drugs coming off patent, so corporations are increasingly looking at biotech start-ups for access to new products to fulfill their development pipeline. About one-fourth of the new drugs launched in the past year were the result of collaborations between companies. There are three major forms of strategic alliances that biotech firms can utilize: licensing technology, full collaborations on R&D and commercialization, and limited agreements on co-marketing or co-promotion. The benefits go beyond financial resources. For instance, the pharma companies can provide the biotech companies with development experience and expertise, regulatory approval support, commercialization capacity (sales and marketing), and manufacturing expertise and resources, all of which are essential for the success of the product in the market. Need for early involvement People outside the biotech industry tend to assume that marketing biotech products is easy because of a built-in demand for cutting-edge products that extend life or enhance the quality of life. They assume that the customers will come to their doorstep the minute an exciting new product gets FDA approval. In fact, the opposite is true. Unlike funding, where most people agree on its importance for the success or even the survival of biotech start-ups, the understandings of the marketer’s role in the company are often mixed. Because most biotech companies are founded and managed by scientists, marketing is often introduced late, as if the marketer’s role only becomes important once the is product is available for sale.  We, at Actis, have realized the importance of marketing and the importance of telling this story early and, hence, have brought together a diverse group of individuals to build the company. There are several reasons why the management should involve marketing early in the process. First, marketing needs to be involved to better assess market potential and commercial viability to guide investment decisions. Based on the analysis of the market size, growth rate, and unmet medical need, the firm can determine therapeutic areas to focus on and develop the product to ensure a high commercial potential. In addition, management should involve marketing in the clinical trial design process as well to make sure that the end points of the trials are commercially meaningful. For example, an end point of 15 percent reduction in cholesterol level would have a very different commercial implication than the end point of 10 percent reduction on cardiovascular associated mortality and morbidity events for a cardiovascular product. Furthermore, it is important to align the company’s scientific messages with its marketing messages early in the pre-market process to ensure a successful launch. It is critical for scientists and management to start communicating the potential value of a product at conferences and seminars or though scientific publications before the product launch. This enables them to get key opinion leaders on board early enough to build a solid foundation for a successful launch.  The biotech industry today faces a lot of hype and attention and it’s difficult to combat the over-generalized press. Marketing in biotechnology needs to foster objectivity, report facts and steer clear of hype. Truth needs to be communicated to both stakeholders and the public. Annual reports are good story-tellers  So, what is the best vehicle for marketing in life sciences?  I believe, it’s the annual report of the biotech company. Despite the fact that privately funded life science companies aren’t required to publish annual reports and despite the fact that most hardcore biotechnology and life sciences drug development companies — besides the CROs and the instrument manufacturers — don’t profit until after 10 or more years of trying to develop a successful product, the annual report gives them a vehicle to communicate their processes and the investments made in their efforts. It communicates the commitment to the cause. Most biotech companies use it as a way to communicate their company’s story, passion and motivation to succeed. They show the process of what it takes to make it happen, the larger global benefit of the contribution. The readers of the report get an appreciation for the challenge at hand and take a long-term view of the efforts. Hence, annual reports can be an intelligent and an extremely powerful way to communicate with your stake-holders, doctors and the media. Smart companies will even want to use that power more than once a year with periodic reports focused on portions of their companies’ endeavors. ]]> <![CDATA[Educate farmers to change behaviour]]> https://biospectrumindia.com/news/95/1161/educate-farmers-to-change-behaviour.html https://biospectrumindia.com/news/95/1161/educate-farmers-to-change-behaviour.html Tue, 11 Oct 2011 11:20:00 +0530 Mr Sekhar Natarajan Former CEO & regional lead, Monsanto A chartered accountant by qualification, Mr Sekhar Natarajan is the managing partner at S N Consultants since September 2010. He was the CEO and regional lead at Monsanto from June 1980 to August 2010. He is the chairman of the company’s listed entity providing strategic counsel, business guidance, and representing the company on several industry forums. It is 10 years since farmers in India planted hybrid cotton seeds with Bt trait technologies, which provide cotton plants in-built insect protection against bollworms infestation, thus leading to lower insecticide use, better boll retention, and higher yields. Bt cotton seeds are widely planted globally as an environment-friendly way of controlling bollworms, which are known to cause maximum yield loss and economic damage to the cotton crop. While there are five competing Bt cotton technologies available in India today, the first revolutionary technology was introduced in 2002 by Mahyco-Monsanto Biotech India (MMB), a joint venture between Maharashtra Hybrid Seeds (Mahyco) and Monsanto Holdings (MHPL). Monsanto is singularly focused on agriculture. To quote Mr Hugh Grant, CEO, Monsanto, “When farmers succeed, we succeed.” We have partnered in enabling farmers’ success for over four of our six decades in India. What is unique to Monsanto is that majority of the field team are from farming backgrounds, who live and work daily with farmers. Their farming background and the company’s singular focus on agriculture gives us a tremendous competitive advantage in understanding our customers’ (farmers) needs. We begin with research to understand farmers’ needs and challenges, and then evaluate the value that our products can create for farmers prior to any product introduction. During 1993 t0 2002, cotton yields, production and acreage had stagnated to around 300 kg lint per hectare, 152 lakh bales and 85 lakh hectares, respectively. Our research indicated that due to heavy infestation by two main groups of insects — first, biting and chewing-type insects known as the bollworm complex and second, sucking pest insects — the cotton crop was largely non-remunerative to India’s farmers. Cotton farmers faced reducing insecticide efficacy against bollworms, and had an urgent need for better insect protection. It is estimated that before 2002, cotton accounted for 50 percent or 16 billion of 33.8 billion-worth pesticides, used in agriculture in India (Agrolook, 2001). On an average, farmers sprayed bollworm insecticides five-to-20 times at a cost between 1,484 to 3,225 per acre (all India average cost was 2,146 per acre) in one cotton season. During the 2001-02 kharif season, the bollworm epidemic is estimated to have reduced the yield of cotton in the North zone by 50 percent. The frequent and regular crop failures for 15 years were attributed to bollworms, particularly to the Helicoverpa armigera insect. Thus, in 2002 Bt cotton technology was launched to offer our farmers the choice and convenience of in-built insect protection to cotton plants, as an option to repeated insecticide spraying for bollworms. We overcame five challenges in the initial marketing of Bt cotton technologies. Category development of agri biotechnology. New segment entry – launching a new technology product in the seed segment. Technology ingredient marketing of a benefit experienced – A seed with a value-added protein unseen at purchase and sowing. Behaviour change to reduce spraying insecticides for bollworms infestation. Limited reach of mass media to educate six million cotton farmers across nine states. Our MMB marketing plans focused on three pillars: category education; value to farmers; and choice of access. Technology education For farmers, seeing is believing. Our research finds that  farmers prefer receiving crop information from fellow farmers, rural retailers, company, agriculture university or department representatives, meetings, and mass media. So, we focused on show-and-tell, and word-of-mouth methods using field demonstrations and farmer meetings, supported by other tools. We reached out to lakhs of farmers and academics, to educate and demonstrate to them, the features, benefits and value created by seed biotechnology, versus using seeds-plus-insecticides (for bollworms).  Field demonstrations and farmer meetings (participants ranging from 15,000-to-10,000) were our main tools in category development and habit change, and to some extent helped overcome the limited reach of mass media. MMB, our seed industry peers in India, and State Agri Universities’ expanding farmer education efforts between 2002-05 laid the foundation for farmers’ belief in the new technology. In 2002, the year of the launch, farmers planted Bt cotton seeds on 72,000 acres; and thereafter from 2003-08 we saw 50-to-100 percent growth every year. Within seven-to-eight years of launch in 2008-09, farmers chose to plant cotton seeds with insect-protection Bt technologies on 90 percent of India’s cotton acres. The immense value created by technology and insecticide savings, doubled cotton production and transformed our nation from a large importer into the world’s second largest cotton producer and exporter. It also helped that Indian seed companies priced the seeds significantly lower (1,600) than the combination cost to a farmer for seed-plus-insecticide for bollworms (approximately 2,500 at the time). Today’s price of Bt insect-protection cotton seeds is approximately 1,000 per packet, only a tenth of cotton farmers’ total input costs, yet making the maximum impact on yield. Functional positioning of technology In the agri input industry, we know that farmers’ core needs are maximum yield and income. Hence, our communication focused on the functional benefits of technology, which is superior bollworm control to cotton plants, so that farmers save more through less insecticide usage, yield more cotton, and earn more income. This is supplemented by biotechnology’s intangible benefits of convenience, peace of mind and savings in time. By embracing biotechnology, farmers have reduced insecticide usage by over 20,000 metric tons annually, reducing agriculture’s impact on the environment and saving billions of litres of water due to reduced spraying. Insecticide usage to fight bollworms in cotton has reduced by 57 percent, which in value became 260 crores in 2008 from 600 crores in 2002. The International Cotton Advisory Council also confirmed that Indian farmers have experienced the greatest benefit from Bt cotton technologies as compared to their peers anywhere in the world. Broad licensing of technology to Indian seed companies offer farmers the choice to access technology in their preferred Indian hybrid seeds of choice. Indian farmers’ seed purchase decisions are driven by suitability to their soil and moisture, and nutrient conditions, than by technology. Today, MMB partners with several Indian seed companies in a broad licensing model. Seed companies offers farmers over 600 hybrid cotton seeds with our and other Bt technologies; and farmers can still choose to use non-hybrid non-Bt seeds. India’s Bt cotton revolution is one of innovation and partnerships. The seed and biotechnology industry, partnering with 6.3 million farmers, governments at the Centre and in nine states, agriculture universities and scientists, rural trade, NGOs, and the industry that uses cotton (ginner, textile, export)  have enabled India’s cotton revolution. ]]> <![CDATA[Awareness about green technology]]> https://biospectrumindia.com/news/95/4628/awareness-about-green-technology.html https://biospectrumindia.com/news/95/4628/awareness-about-green-technology.html Tue, 11 Oct 2011 11:18:00 +0530 Mr Subramani Ramachandrappa CMD, Richcore Lifesciences The author is a first generation entrepreneur, an engineer and MBA from ISB, Hyderabad. Prior to founding Richcore Lifesciences, he was working with biotech major, Biocon. Among the several challenges that we face today, the biggest is population. Human population increased 10 folds over the last 250 years. This exponential growth in population put unsustainable pressure on the delicate ecological balance. We are consuming faster and more than our predecessors and the need to feed has given rise to unabated need for water, food and energy. The industrial revolution created jobs and wealth, but also caused irreversible damage to the environment. The world has recently woken up to this reality and is moving towards providing cleaner and greener solutions. However, many of these solutions are being pushed onto the industry that is already grappling with the economic slowdown and struggling for growth. Regulation and subsidies to incentivize adoption of clean technology are not sustainable and will not provide the required global momentum to restore our environment. We, at Richcore, believe that the need of the hour are green solutions that save costs. We have developed biotech solutions for conventional industries that are greener. Adoption of our technology does not require any capital expenditure (CAPEX) and provides real value to the industry through direct monetary saving. We provide cost-saving enzyme solutions to conserve food, water and energy. Our novel solutions are patented, validated and tested in several countries. We have ensured that the solutions we provide work synergistically creating real value for the end user industry. We provide solutions that address a definite need in the industry and our potential market is in the order of $7-8 billion per annum. However, the real challenge we face is in creating awareness and ensuring that our technology reaches every nook and corner of the world. Solutions for a greener future The global water consumption has been on the rise owing to the need for more food, and domestic and industrial use. Richcore provides enzyme technology for better waste water treatment and increased reuse. Our technology provides close to 25 percent cost saving as compared to the current costs without any need for modifications or additional CAPEX in waste water treatment plants. Population growth in developing and developed countries Source:United Nations Also, increasing population and per capita gross domestic product (GDP) in emerging markets is leading to increased demand for animal-derived products. Global animal feed consumption clearly indicates a need of alternative feed source for animals. Richcore provides enzyme technology that helps convert biomass otherwise unfit for animal consumption into animal feed. The technology has a potential to replace up to 25 percent of food grains used for animals with alternate biomass. With the fast depleting hydrocarbon and natural gas reserves, the world is moving towards increased dependence on alternative fuels. Being a low hanging fruit, food grains are being used for energy needs. The current yields of ethanol from food grains have scope for improved efficiencies. Richcore provides enzyme solutions which help in improving efficiency and value of the resultant co products. We are currently able to improve efficiency of a typical ethanol plant by five percent, at a global level this increment is substantial. Strategies for efficient scale up We spend considerable time and resources in hiring and training the right people from the industry to ensure high quality technical, commercial and back-end support. In infrastructure, Richcore has built a state-of-the-art R&D and manufacturing facility equipped with the best-in-class hi-tech equipment to deliver quality solutions in the shortest possible time. Our innovation process is efficient and designed to co-create with the end user. We have entered into strategic technology out-licensing agreements with global majors who have presence across geographies. These companies provide marketing and logistical support and ensure that the technology meets its ultimate objective of large-scale adoption. This strategy is helping us focus our energies into R&D and technical support. Source: http://www.urbanecoist.com Increasing demand for water Sector Water withdrawals* Water consumption Agriculture 66% 93% Industry 20% 4% Domestic use 10% 3% Evaporation from reservoirs 4% - * Water withdrawals refer to water diverted from streams/rivers and pumped from groundwater aquifers for human use, but not necessarily consumed. Part of the withdrawn water is returned after use. The quantity that is not reused or left in nature represents consumed water, namely water that has evaporated or been incorporated into products and organisms, so that it becomes temporarily unavailable to the other users. Source: World Water Council Consumption pattern of food grains for humans and animals Source:FAO Trend of alternate biofuels produced as of 2005 Source:earth Policy Institute, Renewable Fuels Association ]]> <![CDATA[Right partnerships to aid growth]]> https://biospectrumindia.com/news/95/1355/right-partnerships-to-aid-growth.html https://biospectrumindia.com/news/95/1355/right-partnerships-to-aid-growth.html Tue, 11 Oct 2011 11:17:00 +0530 Mr Sudhir Vaid Chairman & MD, Concord Biotech The author has around 35 years of experience in the development of biopharmaceutical products, production management, marketing, US FDA approvals and strategic planning. His last job assignment was as director-fermentation with Ranbaxy Laboratories, where he initiated and successfully completed biotechnology green field projects. The biotechnology industry is one of the fastest growing sectors with total global sales for the pharmaceutical and biotech sector at around $400 billion. Therefore, this market represents a significant target for the generic companies. Due to the patent expiry of several biotech products, a great opportunity is emerging for the pharmaceutical companies in India. However, these opportunities are also associated with a lot of marketing challenges. If these challenges are understood well by the companies in India, they can definitely have an edge over the Chinese companies. The major formulation companies in India understand these challenges very well as far as the marketing of the finished products is concerned, but it is not well taken by the bulk biopharmaceuticals companies in India who are getting very tough competition from the Chinese companies. Patent issues: The major marketing challenge for the biotech industry is to understand intellectual property (IP) relating to its drug candidates on a variety of levels during the early stages. How strong is patent protection? Will the company have freedom to operate in the regulated or the semi-regulated markets? How will a buyer or partner view the IP rights? How well will the patents hold up against the challenges from generic companies? What plans are in place to develop and commercialize drugs in the US, Europe, Asia and the emerging markets? It is very important to understand the IP-related issues and spend wisely and analyze the global patents to avoid an IP nightmare. Concord Biotech has understood this issue and works to develop its own non-infringing processes to enter the major markets on the day-one launch with its abbreviated new drug application partners to get the maximum advantage of the generic market. Life-cycle of drugs: In a world where new products are constantly entering the market, making other products obsolete, one of the marketing challenges faced by the biotech industry is the selection of the products, understanding its lifecycle and proactively working on adding new molecules to its portfolio in order to reduce any financial risk to the organization. One of the main reasons for the success of Concord is faster identification and commercialization of the product, to get the benefit of the market as an early entrant. This way, Concord enters the market when the product is in its early lifecycle phase. It is very well-known fact that the market for all matured antibiotics or secondary metabolites made through the fermentation route are now controlled by China and they have become a big challenge for the companies in India. For such products, Concord’s team first evaluates their commercial viability and then utilizes its R&D team’s expertise and knowledge base to deliver high quality products at competitive prices. Regulatory issues: The other major hurdles are the different regulatory approvals that delay the entry of a product in the markets. The approvals from the different regulatory authorities come within 24-to-36 months, which makes it very difficult for the companies to enter markets, such as the US, Europe, Japan and Mexico. It requires proper planning to enter these markets and to get the advantage from them. Concord has already got all the approvals from different regulatory authorities, such as the US FDA, EUGMP, the regulatory authority of Japan and among others, and has dedicated facilities for all its products, which makes it different from other companies in the same segment. Global uncertainity: One of the other challenges faced by the biotech industry in India is that due to the global economic uncertainty, companies have become slightly more risk averse in selecting new products for their portfolio. This has led to delay in decision on selection of products for their portfolio. Long gestation period: On certain occasions, the therapeutic segment, to which the company is catering to, can also become a challenge in the short term and critical to the growth of the organization. Usually, for products that fall under the life saving drugs’ category, the generic penetration is much slower as patients don’t like to change the brand and requires convincing the doctors and their patients. Considering the fact that the biotechnology segment is highly capital-intensive, such a prolonged gestation period can affect profitability of the company in the short term. In the long run, this creates a barrier in entry. Companies need to build such a portfolio in which risk from one therapeutic class or product can be mitigated by another, hence not affecting the short-term business profitability. Right partnership: In the biopharmaceutical industry, particularly in the generics sector, the new trend is towards having novel business models, such as hybrid models, between generic and innovator companies, and between generic companies partnering and  third-party sales teams, to increase growth. The benefits from these partnerships are wide-ranging for the generics companies, from better access to R&D capabilities to innovator drugs access and wider penetration in new markets. The challenge is to collaborate with the right kind of partner and Concord is constantly working on identifying such partners and working with them to enter different markets for its existing and new products. Price pressure: Globally, one of the challenges faced by the innovator companies is the pricing pressure on drugs from a larger number of generic players. This erodes profitability and the challenge is to retain market share once the product patent is over. One of the ways to overcome this challenge is the strategy of authorized generics, which are copycat versions of a company’s branded drugs, sold through licensing agreements between the innovator company and generic drug manufacturers. Concord with its expertise in biopharmaceuticals is looking at such opportunities. These are some of the challenges faced by the generic biopharmaceutical companies, and Concord Biotech is proactively working to overcome these challenges in order to create a solid base for the company and to make its business sustainable. ]]> <![CDATA[Dealing with high hopes and slow progress]]> https://biospectrumindia.com/news/95/7272/dealing-with-high-hopes-and-slow-progress.html https://biospectrumindia.com/news/95/7272/dealing-with-high-hopes-and-slow-progress.html Tue, 11 Oct 2011 11:15:00 +0530 Mr Sushil Karwa, MD, Krishidhan Seeds Group Mr Sushil Karwa is a trained commerce and management professional and has been the managing director of Krishidhan for 14 years. Mr Karwa has agribusiness experience of over two decades in corporate development affairs, product placement and agri-biotech product commercialization in India. Dr Anup Karwa, Director-life sciences, Krishidhan Seeds Group Dr Anup Karwa is a bio-entrepreneur and one of the founders of Krishidhan Seeds. He did his master’s in molecular genetics from the University of Leicester, UK, and pursued PhD in plant molecular biology at Dusseldorf University, Germany. The success of Bt cotton has ignited the imagination of both farmers and the industry in India and has become the focus of growth and development of the industry. While planting of Bt cotton in over 90 percent of the area under cotton cultivation and introduction of close to 1,000 hybrids in almost every micro-agri zone has made farmers happy, it has also thrown up many challenges for the industry. Initially, the introduction of a biotech crop in the form of Bt cotton triggered mixed feelings of anxiety and hope among farmers. The cotton crop, which was and continues to be major economic sustenance for poor farmers in rain-fed zones, was getting seriously affected by the recurrent onset of bollworm infestation. This forced the farmers to shift to alternative but less remunerative crops and caused severe economic hardships for them. The shift towards more toxic insecticides also did not provide any relief, but compounded their misery in the form of serious health problems. The success and its consequences The success of Bt cotton was very timely and led to faster adoption of it by farmers. Consequently, the farming sector reported better economic growth without compromising on food security. It has made farmers more technology conscious and ready for new products. Often, during our interactions, farmers ask about new products. Cities in India are growing at an unprecedented rate and are offering lucrative employment opportunities to rural laborers. This is putting severe pressure on the availability of farm labor, which is forcing farmers to go for labor-saving technology, like mechanization and chemical weed control, instead of using conventional farm labor. This warrants that the crops too be tolerant to such chemicals. We are also looking forward to the introduction of herbicide resistance in several crops, so that farm productivity does not suffer due to labor shortage. Another consequence of the success of Bt cotton has been that farmers have started adopting new varieties and hybrids and the rate of seed replacement in other crops has also improved giving the industry an avenue for growth. It has created a win-win situation for both farmers and the industry. At present, the seed industry in India is worth approximately 8,000 crore and is steadily growing at the compound annual growth rate of 10-to-12 percent. Open pollinated (non-hybrid) seeds are being replaced by hybrids and these are getting value-added with genetically modified organism (GMO), for example Bt cotton. This has had a tremendous positive impact on productivity and exports. The private sector dominates the seed business. There is 20 percent business through public sector (notified seeds) and another 20-to-25 percent through multinational companies (MNCs) that are interested only in high-value hybrid seeds. Now, India has become a target for the MNCs as the world seed industry is growing at the rate of 4.3 percent, whereas the seed industry in India is growing at the rate of 10 to 12 percent through diversified crops. Local seed companies in India and small regional players contribute 55-to -60 percent to the seed industry in India.  Innovation is the way forward It is almost imperative that the seed industry invests in R&D. The product shelf-life, which was normally 10-to-12 years (notified or conventional hybrid), is now seven-to-eight years because of high expectations of farmers. In the initial two years, the companies promote and establish the product and, if it performs well, it can do voluminous business in the next four-to-five years. By that time, farmer’s needs change or better substitutes become available. Thus, R&D cost is continuous and very high. Introduction of new biotech crops that would address problems like resistance to pests, bacteria, virus and protection against drought or water logging are the major demands of farmers. We are aware that development and introduction of these complex traits through GMO is an extended and expensive affair. The application of alternative biotechnology through molecular markers is also incumbent upon the availability of natural genes in cultivars or wild species. We are looking at a very challenging problem where the hopes are high and progress is slow and expensive. Thus, Krishidhan is transforming and has evolved its strategy from science to curiosity and now to innovation-driven research. Need for partnerships & policy change Today, seed companies in India are, to a great extent, dependent on MNCs for new technologies. We envisage that innovation-based R&D will play a major role in bringing sustainable and durable products. A company with higher investment is likely to be better able to serve farmers and, hence, grow faster. The industry cannot grow unless it meets the demand of the farmers, and at the same time, in order to survive, it will be required to make heavy investments in R&D. No single industry alone will be able to meet the challenges forced by climatic changes and problems of pests and diseases. Therefore, seam-free and public-private and private-private partnerships are a must. These can be facilitated if public and private R&D are treated at par and be provided generous support for infrastructure and grants for projects in stand alone or partnership mode. Also, in order to sustain the gains and keep the seed industry competitive, changes in government policies will be needed to encourage competition and innovation, streamline science-based predictable regulatory system, no price control and implementation of intellectual property rights to create an investment-friendly ambiance. Such a change in policy is inevitable to accelerate science, curiosity and innovation driven R&D, which, in turn, shall support marketing to overcome strategic and operational challenges and ensure overall agribusiness sustainability and food security. ]]> <![CDATA[Market creation for sustainable business]]> https://biospectrumindia.com/news/95/2499/market-creation-for-sustainable-business.html https://biospectrumindia.com/news/95/2499/market-creation-for-sustainable-business.html Tue, 11 Oct 2011 11:12:00 +0530 Mr Naveen Kulkarni Founder and CEO, Polyclone Bioservices The author did his masters from Queensland University of Technology, Brisbane, Australia. He founded Polyclone Bioservices and led the company to successfully forge drug discovery alliances. He served as the director of business development at Philips Research, where he was associated with a portfolio of opportunities for new business creation in healthcare and energy. Traditionally, from a marketing standpoint, there are only two types of companies. Product-based companies and services-based companies. The typical perception of a biotechnology company is that it is a technology company. The question is how that technology is packaged? If it is packaged as a product, then does it have enough target market numbers to generate a sustainable business opportunity? Alternatively, if that technology is a service, then it almost inadvertently falls into the realm of knowledge-based services creating a niche domain, but with a limited market size. With both the above scenarios, a biotech company is typically faced with the same challenge of market creation. A large company works on systematically building an ecosystem by supplementing with research publications, clinical data and endorsements from key opinion leaders. A small company does not have all the resources to accelerate and influence the adoption rate and has to intelligently balance its financial and manpower resources to achieve an optimum success rate to keep the business afloat. More often than not, the success depends on the company’s ability to raise finance to maintain sustained marketing activity. Eventually, the value capture happens when a larger company decides to ‘spin-in’ this technology or product, if they see a strategic fit in their portfolio. In most cases, it results in complete acquisition, since investors see it as a faster route to return investment. The on-ground challenges before the biotechnology industry as a whole, varies widely from company to company, depending on what vertical it focuses on. At Polyclone, we started as a services company and, predominantly, focused on solving critical problems of genomics platform companies, mainly by applying bioinformatics algorithms. Today, we are proud to see that some of our customers’ products are available in the market and well-accepted by world-class scientific teams. Eventually, we started our first lab-based genomics services and the value addition was that we could offer end-to-end solutions. As a services company, and a small one at that, we had to scale up our offerings in an incremental manner with each customer project giving us scientific validation and financial muscle to add the next part of our solution. Although this wasn’t the ideal situation, it helped us come up with creative solutions for solving capital requirements and marketing challenges. One of the challenges we faced during our early days was convincing customers based only on a set of capabilities  without the right infrastructure or success stories? Here, we were well-supported by academic groups at IISc and, eventually, we set up our first molecular biology lab at UAS Dharwad. Although we started mostly with service projects funded by customers, we had the ambition to pool our knowledge gained over the years into a product that met the needs of the customers. We decided to build products that create value to research and enable accelerated discovery. Our initial customers, mostly from the US and Europe, trusted us even though we did not have a fully working prototype and supported us in validating the product. We released our first product, eprime, together with Eppendorf India and are currently set to launch an enzyme engineering framework that addresses the critical need for optimizing a protein to meet the requirements of industrial processes to function in non-physiological conditions and on non-natural substrates without losing their activity or stability. Similarly, we developed a range of solutions for peptide sequence analysis and validated it with the help of our customers and, soon, we envision having a suite of never-before products to support and accelerate research in proteomics. In molecular biology, we helped design and validate novel diagnostic assays for infectious diseases that are prevalent in India. Not stopping at the molecular level, we added cell biology capabilities. We set up a stem cell biology facility with a partner and are focused on innovations to accelerate stem cell therapy in several areas of medical science. While majority of the companies are focused on mainstream therapy opportunities, our strategy is to develop peripheral technologies that enable faster and more efficient access to such therapies across many disease areas. Over the last five years, we have grown from a small computational biology outfit to an integrated biology research services provider with products, frameworks and services in computational, molecular and cell biology. This is a natural culmination of scientific and business success we have had over the years and fits in perfectly with how our customers and their requirements have evolved. ]]> <![CDATA[Mission: Target heart failure related to diabetes]]> https://biospectrumindia.com/news/95/1943/mission-target-heart-failure-related-to-diabetes.html https://biospectrumindia.com/news/95/1943/mission-target-heart-failure-related-to-diabetes.html Mon, 10 Oct 2011 18:15:00 +0530 The BIPP funding has helped Torrent Pharma conduct trials of its potential discovery molecule targeted at creating drugs for heart failure associated with diabetes Diabetes not only affects the overall health but is also associated with many other ailments including heart failure. To counter diabetes-related heart failure, Ahmadabad-based Torrent Pharma carried out research to find a drug compound ‘TRC4186’, which is a potential candidate to target the disease. The funding through Biotechnology Industry Partnership Programme (BIPP) of the Department of Biotechnology (DBT) helped Torrent to carry out the trials for its advanced glycosylation end (AGE) breaker compound (TRC4186), addressing heart complications due to diabetes. The aim of this study was to determine the effect of TRC4186 on diabetic cardiomyopathy  and nephropathy in animal models of diabetes with progressive cardiac and renal dysfunction. One of the ways in which normal metabolic processes degrade important components in the body (such as kidneys, heart, skin and blood vessels) is through the generation of advanced glycation end products. However, accumulation of these AGEs due to inefficiency of the body to break down can eventually lead to diabetes, various age-related diseases and even death. Fortunately, there are classes of chemical compound drugs known as the AGE-breakers that break up the AGEs. A number of companies have been involved in research and development in this field in the past five-to-ten years. The AGE breaker compound (TRC4186) discovery molecule addresses the issue of  heart complications due  to diabetes. The discovery molecule has been evaluated in vitro and in vivo and has shown to reduce AGE burden. The phase-I clinical trial involving SAD, MAD, FFE and special population (elderly and female) was successfully conducted on 87 subjects in India and the UK. The results showed that TRC4186 clearly preserved cardiac function and reduced the severity of renal dysfunction in animal model with persistent severe hyperglycemia leading to diabetic heart failure and renal failure. Phase II clinical trial in 300 subjects commenced in November 2009, with Indian operations supported by the BIPP. It now rests on the clinical trials based upon animal studies and human studies. Besides India, the molecule holds patents in various countries, including the US, UK, Germany, France, Japan, Russia, China, Canada, Mexico, Brazil and Australia. Torrent Pharma is expecting a maxiumum of 50-crore funding under the BIPP scheme, as this project is of national relevance and involves advanced and high risk technologies, and clinical trials. According to Dr Vijay Chauthaiwale, vice president, discovery research, Torrent Pharma, the immense advantages offered by the BIPP include the enhancing of the funding process, efficiency and transparency. He appreciated the increasing level of sophistication at par with international agencies, such as the NIH, and minimizing paper consumption for loan applications. “While working within the government framework, the BIPP has demonstrated a high degree of commitment to innovation, flexibility and openness to discuss diverse viewpoints, willingness to understand industry’s requirements and limitations, besides being sensitive to industry needs  such as confidentiality and intellectual property  protection,” says Dr Chauthaiwale. Besides diabetes, the BIPP has also funded Torrent’s project on T2 Mimetic (TRC150094), a novel diiodothyronine (T2) analogue, for the treatment of cardiovascular risk factors defined by metabolic syndrome.  — Rahul Koul in New Delhi ]]> <![CDATA[Mission: Produce generic version of exenatide]]> https://biospectrumindia.com/news/95/4011/mission-produce-generic-version-of-exenatide.html https://biospectrumindia.com/news/95/4011/mission-produce-generic-version-of-exenatide.html Mon, 10 Oct 2011 18:14:00 +0530 Utilizing the SIBIRI funding, Vivo Bio Tech is working towards developing and launching the generic version of diabetes-controlling molecule exenatide to reduce treatment cost According to the International Diabetes Federation (IDF) estimate, the number of diabetic patients in India has more than doubled from 19 million in 1995 to 40.9 million in 2007. The projected increase to 69.9 million by 2025, the high incidence levels and absence of a generic version of the widely used drug, exenatide, has increased the suffering of the diabetes patients. Moreover, the commercially available exenatide is synthesized by peptide synthesizer and, hence, is expensive to produce. Therefore, to overcome this hindrance, Hyderabad-based Vivo Bio Tech has initiated a project on recombinant exenatide, an incretin mimetic like GLP-1 receptor agonist, indicated as an adjunct to diet and exercise to improve glycemic control in adults with type-2 diabetes mellitus. The company is developing the product through recombinant DNA technology in E.coli. This method simplifies the process of production, reduces cost and also increases yield. Owing to the large market potential for anti-diabetes drugs, the company is looking forward to developing and launching the generic version of the molecule, thereby reducing the treatment cost to diabetics in India. After approval from the scientific and financial experts designated by the Department of Biotechnology on the technical and economic viability of its project, the company was awarded the small business innovation research initiative (SBIRI) funding through phase II scheme in February 2011. The total project cost of production of recombinant exenatide (incretin mimetic like GLP-1) is 580 lakhs and the funding support from the SBIRI allotted is 340 lakhs. So far, the company has received the first installment of 224.3 lakhs and it has proved to be a major boost for its efforts. The duration of the project is two years. Talking about the importance of funding, Dr A Sankaranarayanan, CEO, Vivo Bio Tech, says, “The funding was very important as the drug development projects involve long gestational period without any income during the development. The funding pattern and repayment schedule offered by the SBIRI is very industry-friendly, as the repayment starts 10 years after completion of the project in 10 equal installments. During this time, we would be able to successfully complete the project, launch the product in the market, generate post-marketing data, and also record significant revenues from the sales of the product.” The way forward According to the company, the project is progressing as per the project implementation plan approved by the SBIRI. Given the positive results, the company is now anticipating submitting preclinical application to the Review Committee on Genetic Manipulation within a couple of months. “We have successfully completed our objectives set forth for the first quarter. These include preparation of cell banks and optimization of lab scale fermentation of recombinant exenatide clones. Now, we look forward to its submission for preclinical submission soon,” says Dr Sankaranarayanan. While praising the efforts of the DBT, Dr Sankaranarayanan says, “The PPP in biotech industry is the single most enabling means to promote biotech R&D in the country. The initiatives by SBIRI, BIRAP and other agencies under the DBT are a boon to small and mid-size companies striving to make a mark in the industry.” ]]> <![CDATA[Tech Solutions CSO]]> https://biospectrumindia.com/news/95/7407/tech-solutions-cso.html https://biospectrumindia.com/news/95/7407/tech-solutions-cso.html Mon, 10 Oct 2011 18:10:00 +0530 The business objective of any BioIT company is to support the pharma companies, which are under tremendous pressure due to rising R&D costs, drying of product pipeline and regulatory hurdles. Companies, such as Strand Life Sciences and CellWorks, have been working towards meeting this aim. In this issue of CSO series, we focus on the contributions of Dr Kalyanasundaram Subramanian, CSO, Strand Life Sciences, and Dr Shireen Vali, CSO, CellWorks, towards development of technology-based solutions to enable drug discovery R&D, improve productivity and success rate of the process, reduce costs, increase efficiency, and identify potential side-effects. ]]> <![CDATA[Targeted drug therapies]]> https://biospectrumindia.com/news/95/1086/targeted-drug-therapies.html https://biospectrumindia.com/news/95/1086/targeted-drug-therapies.html Mon, 10 Oct 2011 18:06:00 +0530 Dr Shireen Vali, CSO, CellWorks Group CellWorks, one of the fast growing companies in India, was recently awarded the Emerging Company of the Year 2011 award for outstanding contribution to the field of bioinformatics and systems biology sector by the Government of Karnataka. Spearheading the research division of this organization is Dr Shireen Vali, who co-founded the company with her husband, Mr Tahir Abbasi, and Mr Pradeep Fernandes. Following her graduation from Osmania University, Dr Vali went to the US where she carried out preliminary research work in the City of Hope National Medical Center, California. Dr Vali then received her PhD in neurobiology from the University of California and since then she has been actively involved in elucidating the pathways involved in various diseases. Her post-doctoral work at Stanford University focused on cystic fibrosis following which she worked in the field of cancer biomarkers. Dr Vali came back to India in 2003 and joined the Institute of Bioinformatics and Applied Biotechnology (IBAB) as a faculty member. It was here that the idea for CellWorks was incubated. Dr Vali’s research interests mirror those of the organization’s, which consist of elucidating pathways involved in complex diseases and using systems biology to create disease models that can then be used to design targeted drug therapies akin to personalized medicine. Dr Vali has worked towards setting up co-culture systems of various disorders, such as rheumatoid arthritis, cancer and wound healing consisting of systems involving over eight cell types, including osteolclasts, T cells, endothelial cells, epithelial cells macrophages and dendritic cells. On the approach they have adopted in discovering drug therapies, Dr Vali says, “We carry out retrospective validations with data that is existing but has not been used to build or align the systems and also, prospective validations with global collaborators, who have tested their predictions.” Focus on rheumatoid arthritis has yielded two combination drugs, one of which has completed animal trials and the other is entering the preclinical stage. Cancer, a multiphenotypic disorder presents a major challenge, one that is tackled in a unique manner, explains Dr Vali. “We have enabled the co-culture systems to incorporate all the components such as angiogenesis and metastasis by using the cellular models in the tumor system. Focusing on specific cancer types, which are epithelial in origin, we profile the tumor based on the key mutations and these mutations are overlaid on the system to generate a dynamic tumor state, which matches in terms of mutations with those found in certain cell lines. Based on the different types of mutations, the tumor has differential sensitivity to different drugs and using this information we are able to customize the drug profile for a patient or a group of patients,” says Dr Vali. Collaborations with different institutions, such as Astra Zeneca, City of Hope San Diego, University of Cancer UK and National Institute of Singapore, have resulted in many publications in reputed journals. One study carried out in collaboration with National Institute of Mental Health and Neuro Sciences, Bangalore studied the effect of curcumin for treatment of Parkinson’s using a virtual dopaminergic neuron consisting of astrocytes and microglia, which helped ascertain the effects of curcumin. This system gave many insights on how to correlate the effect of curcumin. Talking about the road ahead, she says, “In the next five years, I would like some of our drug combinations to be in the later phases of clinical trials. It is an aggressive strategy, but one which will help us get therapies out in the market as soon as possible to help the people suffering from these diseases.” — Manasi Vaidya in Bangalore ]]> <![CDATA[Model to screen toxicity]]> https://biospectrumindia.com/news/95/2378/model-to-screen-toxicity.html https://biospectrumindia.com/news/95/2378/model-to-screen-toxicity.html Mon, 10 Oct 2011 18:04:00 +0530 Dr Kalyanasundaram Subramanian, CSO, Strand Life Sciences The current trend in the life sciences industry of using innovative approaches to solve existing problems is a refreshing one and a pioneering leader in this field has been Strand Life Sciences. Leading the research and development at Strand is its chief scientific officer, Dr Kalyanasundaram Subramanian. In 2005, Dr Subramanian or Kas, as he is popularly known, moved back to India, after working at Entelos, a US-based life sciences company, where he headed the group for inflammation and immunology and joined Strand Life Sciences, then known as Strand Genomics. At Entelos, he helped build models of disease pathology and physiology, such as rheumatoid arthritis and HIV. Dr Kas, a graduate in chemical engineering from IIT Bombay, followed by a masters degree from State University of New York College at Buffalo, pursued his PhD in biomedical engineering from Johns Hopkins University.  Post his PhD, Dr Kas took up the position of senior scientist at Genetic Therapy (Novartis) where he helped set up a group to perform research in synthetic and hybrid vectors for gene delivery. At Strand, Dr Kas has been involved in the design of structure activity relationship (SAR) models. Besides that, he is closely associated with a project on virtual liver for the last six years. Elaborating on his association with this model, Dr Kas explains, “One of the major challenges with pharma companies is how to make drugs safe. The most common form of toxicity is liver toxicity. Around one in five compounds fail in clinical trials due to toxicity. We have been using a systems approach towards solving this problem. The first phase consisted of building a model that could reproduce the normal physiology of the liver correctly. Once this was done the normal physiology was then altered to mirror a diseased state through literature validation.” In the next phase, a set of specific assays involving parameters of liver physiology, were designed, which when combined with the model could trace the evolution of the disease and elucidate the mechanism involved. This model has been validated through blinded trials by using drugs, which are known to cause liver toxicity. Dr Kas hopes to offer this groundbreaking technology to pharma companies, which may save millions of dollars before clinical trials as it helps to screen out those drugs that will cause toxicity. An additional advantage is that this approach will help reduce the use of animals for testing and hence further drop costs. The current model is a rat liver and now that it has been fully developed Dr Kas hopes to further replicate this system for a human or dog liver. Another project that Dr Kas is closely involved with, which is still in its infancy, is finding the molecular basis of cancer. In collaboration with Kidwai Memorial Institute of Oncology, Indian Institute of Science (IISc), Bangalore, the team at Strand has profiled more than 100 breast cancer patients molecularly and used that information to address many questions about cancer. Using this information, Dr Kas aims to help doctors design effective and personalized therapies for a group of patients showing similar characteristics on the molecular level. He explains, “We are trying to find out what makes one person’s cancer different from the other person’s cancer and how it can be treated differently. The goal is to personalize the treatment to minimize the side effects and, also, try to develop cheap diagnostics to detect these molecular differences. We hope to get at least one or two diagnostics out in the market costing around $500, which will help design better therapies in the next five years.” This project is going to be one of the major thrust areas for years to come with collaborations with St Johns Hospital, Bangalore and Mazumdar-Shaw Cancer Hospital, Bangalore. ]]> <![CDATA[Fuel of the future: A success story]]> https://biospectrumindia.com/news/95/1989/fuel-of-the-future-a-success-story.html https://biospectrumindia.com/news/95/1989/fuel-of-the-future-a-success-story.html Mon, 10 Oct 2011 18:02:00 +0530 Karnataka’s first-of-its kind biofuel park in Hassan has set an example for others. With the extension of the project to the entire state, it expects to generate revenue of about 1,100 crore per year and, also save on the oil bill In 2006, the University of Agricultural Sciences, Bangalore, initiated a biofuel park project at Madenur in Hassan district of Karnataka to encourage the biofuel industry. The local farmers were supplied saplings of Pongemia, Simarouba, Neem, Jatropha and Mahua, tree species that produce non-edible oilseeds, worth 14.25 lakh free of cost. Today, the farmers are reaping the benefits of the crop, while the project’s success has led other states of India, like Chhattisgarh, Orissa, Jharkhand, Gujarat and Madhya Pradesh, and countries, like The Netherlands and Denmark, to follow the example. Energy scenario in India India’s energy demand is expected to grow at an annual rate of 4.8 percent over the next couple of decades. As much as 34 percent of the Centre’s financial budget is allocated to import of petroleum fuels with over 3.75 lakh crore being spent on their purchase. The biofuel policy was passed in India in 2009, which aimed for 20 percent blending of biofuels, that is either bioethanol or biodiesel, in petroleum fuels by 2017. Keeping this in mind, many state governments have initiated various programs to achieve these objectives. The decentralized initiative is reminiscent of the co-operative movement involved in the procurement of milk. By extending the project to the entire state, the government expects to generate reveue of about 1,100 crore per year and save foreign exchange. The farmers planted the saplings in the backyards of their houses, on bunds and wastelands. Today, there are 430 farmers’ associations for collection of oilseeds and the farmers are paid an amount above the minimum support price fixed by the government. The first-of-its-kind initiative Karnataka has been known for setting benchmarks in new areas of businesses, such as information technology and biotechnology. In March 2009, it became the first state in the country to announce the State Biofuel Policy in line with the National Biofuel Policy of the Government of India announced on September 12, 2008. Though the policy was announced only in 2009, the Karnataka government had taken many initiatives to encourage the biofuel industry even before the policy was announced. The Hassan project, 194 kms from Bangalore, was one of them. The project is the first-of-its-kind initiative in the country and Hassan district was chosen for its variety of climatic conditions that is similar to most parts of the country. Aims of Hassan Biofuel Park Utilization of 5.62 lakh hectare of agriculture land for plantation on bunds and 0.28 lakh hectare of degraded land for mixed plantation in Hassan district. A farmer gets 200-to-2,000 as extra income. Approximately, 50-60 man-days of employment is generated per year per family By growing five plants per hectare in agriculture land on bunds and approximately 70 plants in wastelands, 29,000 tons of seeds and 8,800 tons of oil can be obtained after six years Environmental protection and soil moisture conservation Marketing of oil at the rate of 30,000 per ton is expected to fetch 30 crore A co-operative initiative This initiative, which aimed to provide an additional means for sustenance to farmers, will eventually help create a network for the procurement of oilseeds for the biofuel industry. Dr BalaKrishna Gowda, project co-ordinator at Hassan Biofuel Park, explains, “This approach requires very little effort from the farmer who gains additional income via products, such as oilseeds, and enjoys a high rate of success because they are directly involved in the process.” He said that there are 70 biofuel villages in the district and each household grows any one of the given tree species. In addition to providing saplings, the biofuel park is also associated with innovations in the machinery involved in biofuel production and the transfer of this technology directly to the farmers. Dr Gowda said more than 1,150 awareness meetings and training programs have been conducted in the last few years involving over 70,000 farmers. “As many as 50 percent of them were women participants. These farmers had planted about 14.5 lakh seedlings over 15,000 acres of land in Hassan district,” he elaborates. Dr Gowda adds that the decentralized approach results in less carbon footprints in the production of biofuels. “Biofuels would lose their sheen if thousands of litres of fuel were burnt to transport seedstock from the field to the factory. Hence, biodiesel production units are being set up at the taluk and district levels to minimize costs and efforts involved in transportation of seedstock,” he says. Alternative fuels Worldwide, Brazil has been at the forefront of producing biofuels since the 1980s. It is the world’s leading producer of bioethanol and uses sugarcane to produce it, while some South East Asian countries use palm oil and the US uses corn and soyabean. To avoid the food versus fuel debate raging in the West, India has focused on non-edible oilseed crops and trees that have short gestation period and can be grown in harsh conditions. According to Mr Y B Ramakrishna, chairman of the Karnataka State Biofuel Board, India has a huge potential in the production of biofuels. Stressing on the need for a proactive government to integrate production of biofuels with industrial practices, he says, “India is the largest producer of sugar with Uttar Pradesh, Maharashtra and Karnataka being the leaders. There is a huge untapped market for production of bioethanol from molasses produced in the sugar factories. We are encouraging the factory owners to set up bioethanol production plants, so that this resource can be effectively utilized.” Mr Biligiri Kadambi, director of Southern Biofuel Technologies, says, “Bioethanol has the potential to make a huge industry impact. However, actively producing and distributing it is not a very viable option right now because it comes under the liquor bracket and additional taxes are applicable.” Biodiesel on the other hand has caught the fancy of entrepreneurs nationwide. Once the hype surrounding Jatropha died down, researchers started looking at other non-edible varieties of oilseeds, trees, shrubs and algae to produce biodiesel. Algae is being looked at with a lot of interest as they have a high biomass yield per unit of light and area and do not require agricultural land. Problems in sourcing seedstock One of the problems that entrepreneurs face initially is the lack of a consistent supply network of seedstock and the raw material used to produce biodiesel. Mr Julesh Bantia, head of Eco Green Fuels who has established a biodiesel producing unit in Bangalore, says, “The most important factor for any company in the biofuel industry is the regular and continuous availability of seedstock. There is a lot of volatility associated with prices of seedstock, which decide the profits for any company. Soap industries offer higher prices for seedstock and, hence, emerge the biggest competitor for seedstock for biofuel industries. The biodiesel producers cannot compete with these prices due to the high production costs. The government should take concrete steps to fix the price of seedstock, so that both parties can benefit.” Jatropha’s downfall According to the Biodiesel Mission of 2002, jatropha was planted on over 50,000 hectares of land in eight states. But the enthusiasm surrounding jatropha died down due to various reasons: Jatropha is a hardy crop and can survive in any geoclimatic conditions. Hence, it was expected to give high yields without inputs, such as irrigation and pesticides, but the yield of seeds in harsh conditions was found to be very low. The expected number of seeds or the yield was 4-to-16 kg per tree but the actual number of seeds was found to be 0.4-to-0.5 kg per tree Long gestation period Toxic oil cake produced after extraction of oil. One kg oil produces two-to-three kgs of oil cake Seeds are available only for two weeks Mr Kadambi of Southern Biofuel Technologies said they took some initiatives to circumvent this problem. “At our facility in Gujarat, we have our own 1,000 acres of land where we grow crops, like safflower, castor and argimone, a variety of poppy, which are then used for the production of biodiesel. As we are in direct contact with the seedstock, we can make use of the byproducts such as de-oiled cake, flower petals, among others. These can be further processed to be used as fertilizers or animal feed or used to generate biogas. These value-added integrated practices are very essential in helping the industry survive and grow.” New initiatives in biofuel sector Petroleum companies are waking up to the advantages of blending biofuels and are taking steps to facilitate it on a larger scale. Bharat Petroleum, in collaboration with Hassan Biofuel Park in Karnataka, is going to open an outlet to sell blended biodiesel shortly. The Indian Oil Corporation recently signed a memorandum of understanding with the Department of Biotechnology, Government of India, to set up the Centre for Advanced Research on Bio-energy in Faridabad to work towards developing sound technology to produce biofuels. Among the various myths associated with biofuels is the belief that various engine modifications need to be carried out for their use. Mr CS Bhaskar, managing director and CEO of Naturol Bioenergy that has 12 retail stations selling biodiesel in Andhra Pradesh, explains that this was not true. “All engines built after 1996 do not use rubber and hence no change in the engine of the automobile is necessary. The use of biodiesel in a conventional diesel engine results in substantial reduction of unburned hydrocarbons, carbon monoxide, and particulate matter. It also decreases solid carbon fraction of particulate matter as the oxygen in biodiesel enables more complete combustion to CO2. For every ton of biodiesel used, the release of three ton of CO2 is prevented,” he says. The cost of biodiesel remains an impediment. Industry experts say the price, though fluctuates, remains around 15 percent more than diesel. Subsidies offered on crude oil, which drastically reduces its price further, prevent biofuels from being able to compete with them. “The government should either offer similar subsidies to biodiesel or remove the value added tax on biodiesel,” says Mr Bhaskar. “Biofuels, being promoted as an environmentally sound approach, would lose their sheen if thousands of litres of fuel were burnt to transport seedstock from the field to the factory. Hence, biodiesel production units are being set up at the taluk and district levels to minimize costs and efforts involved in transportation of seedstock” — Dr Balakrishna Gowda, Project co-ordinator, Hassan Biofuel Park “At our facility in Gujarat, we have our own 1,000 acres of land where we grow crops, like safflower, castor and argimone, a variety of poppy, which are then used for the production of biodiesel. As we are in direct contact with the seedstock, we can make use of the byproducts such as de-oiled cake, flower petals, among others” — Mr Biligiri Kadambi, Director, Southern Biofuel Technologies “India is the largest producer of sugar with Uttar Pradesh, Maharashtra and Karnataka being the leaders. There is a huge untapped market for production of bioethanol from molasses in the sugar factories. We are encouraging the factory owners to set up bioethanol plants, so that this resource can be effectively utilized.” — Mr YB Ramakrishna, Chairman, Karnataka State Biofuel Board “All engines built after 1996 do not use rubber and hence no change in the engine of the automobile is necessary. The use of biodiesel in a conventional diesel engine results in substantial reduction of unburned hydrocarbons, carbon monoxide, and particulate matter. It also decreases solid carbon fraction of particulate matter.” — Mr CS Bhaskar, MD & CEO, Naturol Bioenergy — Manasi Vaidya ]]> <![CDATA[A fix for real time delivery in stem cell therapy]]> https://biospectrumindia.com/news/95/5476/a-fix-for-real-time-delivery-in-stem-cell-therapy.html https://biospectrumindia.com/news/95/5476/a-fix-for-real-time-delivery-in-stem-cell-therapy.html Mon, 10 Oct 2011 18:00:00 +0530 A therapeutic model by US-based Cytori Therapeutics can process human fat and derive adipose-derived adult stem and regenerative cells for repair and restoration of damaged tissues in an hour’s time Dr Anup Dhir, a senior consultant and surgeon in New Delhi, recently undertook a facial rejuvenation procedure on a 58-year-old patient. Rather than putting her through tedious and time-consuming procedures, like plastic surgery, he opted for an unconventional method. He pulled the fat from her abdomen and used a medical device called Celution System to process the fat for cell-enriched graft. The processing took around an hour and Dr Dhir completed the entire treatment procedure on the patient in four hours. So far, India has had 10 such cases where doctors have used the Celution System, a product of US-based company Cytori Therapeutics, to process human fat and derive adipose-derived adult stem and regenerative cells (ADRCs) to repair and restoration of damaged tissues. Contrary to the popular belief that adult stem cells can only be found in the bone marrow, a team of experts at Cytori proved the potential of ADRCs to repair or restore lost and damaged tissues and organs. Derived from adipose tissues, these cells hold key advantages over stem and regenerative cells from other sources. The team  proved that these ADRCs contain a higher frequency of stem cells than any other autologous adult stem cell source and can be harvested with minimal pain and discomfort through a simple, minimally invasive liposuction procedure performed under local anesthesia, which takes 20-30 minutes. Lastly, they can be processed quickly to yield stem cells in a sterile, automated system. The genesis Ten years ago, when the standard procedure to derive stem cells was culturing the cells derived from a patient in a tissue culture media, the team at Cytori was looking at a different therapeutic model, which would largely focus on real time delivery of the patient’s own ADRCs. The model was to also look at cutting down time, between the period when cells are extracted from a patient, isolated and processed, till the time when these stem cells are administered to the patient for treatment, cost-effective. “We started off with cell culture of stem cells because that was the norm at that time. But then we realized that cell culture was not the only route. Ideally, there are three weeks between harvesting the cells and treating the patient. For some diseases, it may work but, clearly, not for all. Also, culturing to a great extent changes the properties of the patient’s cells,” says Dr John Fraser, principal scientist at Cytori Therapeutics. The core team at Cytori spent nearly $300 million for working on methodologies to derive ADRCs from human fat. They divided their work into two areas. One was to develop systems on how these ADRCs would work on patients and the other was to bring out a medical device. “We first developed manual systems, which could cover the entire process of harvesting, processing and isolating, in five hours, in a closed system that was clinically more appropriate. We then realized that this process could be faster and came up with a device that allowed the entire process to be completed in 60-90 minutes,” recalls Dr Fraser. “Through this device, we could give autologous cells in real time.” Dr Fraser believes that the Cytori ADRC therapy has an upper hand over other forms of cell therapy because it would enable surgeons with real-time, point-of-care access to a patient’s own ADRC, offers no risk of rejection phenomena by the body, has no costly laboratory requirements, and there are no operating room time and work flow delays. Cytori ADRC therapy is cells harvested from a patient for the same patient within the same procedure. In addition, it enables the harvested ADRCs to be mixed with adipose extracted for use as grafts to create a cell-enriched graft for immediate re-implantation into the same patient. These enhanced fat grafts enjoy long-term retention and are, therefore, a far better, natural alternative to artificial implants for breast reconstruction or augmentation. Opportunity in India Top officials from the company believe that India has a basket of market opportunities to offer to Cytori Therapeutics (for Celution in particular) with the cosmetic surgery market being the prime focus area. Around 31 per cent of India’s medical tourism business today comes from cosmetic surgery and statistics from ISAPS survey reveal that eight percent (683,160 cases) of surgical and 2.4 percent (211,540 cases) of non-surgical procedures were conducted by Indian doctors last year. Advantages of Celution System Improved graft survival and predictable outcome Addition of ADRC to fat graft improves graft survival Automated standardized cell & tissue processing Cell-enhanced graft produced in approx 90 min “We believe that there is a burgeoning consumer demand for natural soft tissue filler that is both safe and effective. Consumers are seeking alternatives to silicone breast implants and synthetic fillers, such as Botox and hyaluronic acid. Worldwide, this alternative appears to be one of the fastest growing areas of plastic and aesthetic surgery,” says Dr Fraser. In a span of six months, the company has conducted 10 procedures using the Celution System in India across four institutions, including private hospitals like Fortis and Apollo (Hyderabad and New Delhi, respectively), which includes cases of facial rejuvenation and facial reconstruction. “India is a fast growing market and is presently ready for medical devices that require low-cost operations. In such a context, we think that our device is very relevant because India’s healthcare system is understaffed in terms of technicians and nurses. Moreover, a lot of time and resources go in training them. This is a device that the doctor can operate himself,” says Mr Rohit Nand, principal consultant (India), Cytori Therapeutics. The company has set up a marketing and sales office in Mumbai with five people. “We are looking at partnering with private and public hospitals to bring regenerative medicine to India. We expect to increase our investment as more hospitals adopt this new technological platform for their patients. We have the capability of rolling out 20 centers and, in 2011, we are looking at 10 such centers,” says Dr Fraser. Pricing strategy In India, Cytori Therapeutics is looking at two distinct segments of the population. While one segment constitutes of top-level patients willing to pay any price for high-end therapies, there is also the rising middle class that cannot be ignored. Hence, the task in a country like India is to find an appropriate pricing strategy. “Nobody can come here and replicate the same model that they have applied in markets like the US. We offer the same treatment at a lower price of 1.95 lakh and we will get to a point where we will be competitive. You can’t just sell the device, you need to sell the service too,” adds Mr Nand. The company has formulated a price band for emerging markets, like India. “The price of this product in the emerging markets is $225,000. But this price is a package of products and services that we offer and comes with professional staff and surgeons, technicians, engineers, training and follow-up training. A surgeon can’t just walk into our center to buy this product. We have to invest a lot of resources and time in training them,” says David Oxley, vice president of emerging market sales and marketing, Cytori Therapeutics. The future Cytori products have been used at more than 150 institutions in more than 30 countries and have treated more than 3,000 patients. In India, Cytori will introduce a host of cell therapies across the country based on current CE Mark-approved cell therapies in Europe. These would include cell therapy in the area of burn repair, scar remodeling, and wound healing to Crohn’s disease, cosmetic and reconstructive surgery indications, including breast reconstruction, breast augmentation, facial reconstruction/defect repair, buttock augmentation. During the medium term, Cytori will also expand the use of the Celution cell therapy platform by addressing acute and chronic heart disease. — Nayantara Som in Mumbai ]]> <![CDATA[Dr Reddy's starts CETP inhibitor study]]> https://biospectrumindia.com/news/95/7760/dr-reddys-starts-cetp-inhibitor-study.html https://biospectrumindia.com/news/95/7760/dr-reddys-starts-cetp-inhibitor-study.html Mon, 10 Oct 2011 17:57:00 +0530 Dr Reddy’s Laboratories initiated dosing patients diagnosed with type II dyslipidemia with DRL-17822. DRL-17822 is a selective, orally bioavailable inhibitor of cholesteryl ester transfer protein (CETP), for the treatment and prevention of dyslipidemia, atherosclerosis and associated cardiovascular disease. The current study is being conducted under a CTA in a number of countries in Europe. The objective of the study is to evaluate the efficacy and safety of DRL-17822 in patients with type-II dyslipidemia. This is a randomized, double blind, placebo controlled, parallel group study in 160 subjects. The primary outcome measure is to assess the elevation in HDL cholesterol and reduction in LDL cholesterol from baseline to end of treatment compared to placebo. Three doses (50, 150 and 300 mg) of DRL-17822 given once daily for four weeks will be evaluated during this study. India, Canada to foster joint R&D Under the Canada-India agreement for scientific and technological cooperation, the governments of Canada and India have agreed to foster joint research and development (R&D) projects by implementing Ontario/India Collaborative Research Fund (CRF). While the Indian side is being represented by the Department of Biotechnology (DBT), Ministry of Science and Technology, Government of India, the Canadian side is represented by the International Science and Technology Partnerships Canada (ISTP), a non-governmental organization selected by the Ministry of Research and Innovation (MRI), Government of Ontario, Canada. The program is open to R&D projects in all areas of biotechnology, including life sciences and medical devices. CSIR starts research on Ayurgenomics The Council of Scientific and Industrial Research (CSIR) has established a new line of research named Ayurgenomics, which is an integrative approach of Ayurveda and Genomics, for the discovery of predictive markers for preventive and personized medicine. This was revealed by Minister of State for Science and Technology and Earth Sciences Ashwani Kumar at the foundation day celebrations of CSIR in New Delhi on September 26. While praising the efforts of CSIR in this direction, the minister said, “This has given a novel molecular framework for integration of these two disciplines and will accelerate discovery of markers for predictive and personalized medicine. We need to create new platforms for innovation, nurture them and make them global.” After the success of Open Source Drug Discovery (OSDD), the CSIR launched Distributed Organic Chemical Synthesis Programme (DOCS) in open source mode. The program has emerged as a new platform for innovation in the domain of healthcare with the global partnership of more than 4,500 researchers from over 100 countries as registered participants. DBT, EC collaborate for waste water treatment solutions The Department of Biotechnology (DBT), Government of India, and European Commission have come together to support the development of innovative biotechnological waste-water treatments for improved water recycling for agriculture and to improve water use. The objective of the pilot initiative is to support strategic cooperation between India, the EU and member states for addressing more effectively global societal challenge in water and bio resources related issues. The project will develop applications for waste water treatments, leading to a greater integration of researchers and activities across India and the European Union. Through this program, DBT intends to encourage multi-institutional networked program with cross disciplinary partnerships The project funded under this activity is an important building block of the pilot initiative for developing EU and member states for strategic research and innovation agenda with India. The participation of industry, including SMEs, is expected to contribute to bring a market-oriented innovation in this field in order to address the social dimension of the project. A wide co-ordination of research activities in the topic area between India and the EU, which are both major players in these fields, will contribute to step up the India-EU collaboration in scope and scale. The collaborative project includes the large-scale integrating project targeted at small and medium scale enterprises. ]]> <![CDATA[Glucose monitor with audio alerts]]> https://biospectrumindia.com/news/95/6430/glucose-monitor-with-audio-alerts.html https://biospectrumindia.com/news/95/6430/glucose-monitor-with-audio-alerts.html Mon, 10 Oct 2011 17:55:00 +0530 LifeScan, a Johnson & Johnson company, launched a breakthrough new blood glucose monitoring device specifically designed to make self-monitoring simple and meaningful for the millions of Indians with diabetes. Called Onetouch SelectSimple, the blood glucose monitor offers a simple, affordable and effective option for self monitoring of blood glucose levels. Most diabetics rank complexity of usage and difficulty in interpretation of device output as among the greatest barriers to self-monitoring. SelectSimple addresses these specific needs and was developed post extensive research among doctors, nurses and patients in India over the past two years. Furthermore, India is the first country in the world to launch this innovation. SelectSimple is the first meter to be launched with audio alerts. There are two alerts corresponding to high and low glucose levels. These alerts automatically go off whenever the readings cross the cut-off limits. So, the benefit to the patients is simple: if the meter alerts, the readings are of concern and the patient must take some action as advised by their healthcare professional. The product also has visual alerts via the use of arrows on screen, as well as a high-low alarm reference card where the patients can put down their readings and maintain a record. Ranbaxy UK launches esomeprazole Ranbaxy (UK) launched esomeprazole 20 mg and 40 mg tablets, the first approved generic bio-equivalent version of the product Nexium, in the United Kingdom (UK), with annual UK sales of $96.7 million, according to IMS June 2011. The product will be offered through pharmacies, retail and wholesale stores with immediate effect. Esomeprazole is used in the treatment of dyspepsia, peptic ulcer disease, gastroesophageal reflux disease and Zollinger-Ellison syndrome. Ranbaxy (UK) is the wholly-owned subsidiary of Ranbaxy Laboratories in the UK. Established in 1994, it is today one of the major generic companies in this market providing medicines in the cardiovascular, CNS, anti-infective, gastroenterology, anti-viral, anti-inflammatory, oncology and pain relief therapeutic segments. Lupin launches generic Keppra XR India-based Lupin Pharmaceuticals has announced that the US FDA has granted final approval for the company’s abbreviated new drug application to market a generic version of UCB’s Keppra XR tablets. Commercial shipment of the product has commenced. Lupin’s levetiracetam 500 mg and 750 mg extended-release tablets are the AB-rated generic equivalent of Keppra XR, an antiepileptic drug indicated for adjunctive therapy in the treatment of partial onset seizures in patients 16 years of age or more with epilepsy. Keppra XR tablets had annual sales of approximately $161 million for the twelve months ended June 2011. Venus Remedies to market Docetaxel Chandigarh-based Venus Remedies has recently received market authorization (MA) for its anti cancer product, Docetaxel. The company’s wholly-owned subsidiary, Venus Pharma GmbH, Germany, has received this MA for Portugal. The versatile anti-cancer drug is considered as one of the largest oncology products, which is used mainly for the treatment of breast cancer, non-small cell lung cancer, prostate cancer, gastric adenocarcinoma, head and neck cancer and ovarian cancer. Venus is all set to launch this anti-cancer drug in the market by the end of 2011 and it has also filed a patent for this product.  A semi-synthetic cytostatic taxane analogue, Docetaxel was initially developed by Sanofi-Aventis and is marketed under the brand name Taxotere. The molecule patent protection of Sanofi-Aventis has recently expired in major European countries while in rest of the countries, the expiry of patent is due in November 2013. This recent patent expiry has further enhanced the prospects for Venus Remedies to market Docetaxel and capture a significant market share where at present the European market of Docetaxel is worth around $1.6 billion. Currently, Venus is marketing Docetaxel under the brand name Doxol in various emerging markets of Africa, Asia, CIS and LAC. The company has also filed dossiers in many countries where the product is in the process of registration. Besides this product, the company is also contributing successfully in the oncology segment for Europe through its wide array of key products, which includes Paclitaxel, Gemcitabine, Oxaliplatin, Irinotecan and Topotecan. ]]> <![CDATA[12 BT finishing schools in Karnataka]]> https://biospectrumindia.com/news/95/5527/12-bt-finishing-schools-in-karnataka.html https://biospectrumindia.com/news/95/5527/12-bt-finishing-schools-in-karnataka.html Mon, 10 Oct 2011 17:52:00 +0530 In a gala function on September 15, 2011, the Karnataka government launched the ambitious project of BT Finishing Schools in Bangalore. Twelve biotechnology finishing schools in eight districts of Karnataka were launched on this occasion. The institutions to host this program were chosen on the basis of available infrastructure and faculty and collaborations with industry. Depending on the facilities available, any of the eight domains, such as fermentation and bioprocessing, cellular and molecular diagnostics, protein expression & scale-up, nutraceuticals and food processing, plant genetic transformation, genome, seed and marker analysis, bioinformatics and rational drug design, pre-clinical, clinical research, biostatistics and data management and plant tissue culture and micro propagation. The 12 institutions that have been identified are Visvesvaraya College of Applied Sciences, Gulbarga, Manipal University, Manipal, St Aloysius College, Mangalore, JSS University, Mysore, Oxford College of Science, Bangalore, Maharani Lakshmi Ammani College for Women, Bangalore, Padmashree Institute of Management, Bangalore, PES Institute of Technology, Bangalore, Siddaganga Institute of Technology, Tumkur, Probiosis, Bangalore, MM Arts & Science College, Sirsi and Dayanandsagar Institution, Bangalore. The event was presided by dignitaries, such as Dr Kiran Mazumdar Shaw, CMD, Biocon and chairperson, Karnataka’s Vision Group on Biotechnology, Prof Padmanabhan, Indian Institute of Science IISc, Bangalore, Mr M N Vidyashankar, principal secretary, e-Governance, IT, BT and S&T Department, Government of Karnataka. FDI not equivalent to high price: GSK CEO Mr Andrew Witty, chief executive officer (CEO) of GlaxoSmithKline, while speaking at the recent annual general meeting of the Organization of Pharmaceutical Producers of India in Mumbai on September 27, said foreign ownership of Indian companies did not equate to  high price of medicines. “The reality of the situation is that putting a cap on foreign investments sends wrong signals about India to the world. Foreign investments connect India globally on the R&D front. Foreign companies open doorways for India in terms of exports.” He added that if India had to go up the value chain, it must focus on  drug discovery R&D, which can happen only from exposure of international companies. He also said if the IP regime in India did not address the issue of providing appropriate shield and protection to foreign companies, the probability of  high-risk research in India would be low. “Foreign investors need to have some certainty that their risk will be rewarded. This would be a stimulus for R&D in India,” Witty said. He also pointed out that IP protection did not amount to high pricing of medicines. Later, speaking to the media, Mr Witty said GSK was on the lookout for acquisitions in India but  they were more disciplined while allocating capital for acquisitions. “We continue to look out for acquisitions, but the right deals (which are) somewhere in the $1-to-2 billion mark.” GE, Veran form strategic alliance GE Healthcare, the $17 billion healthcare unit of General Electric Company, and Veran Medical Technologies, a privately-held medical device company, entered into a strategic alliance to advance and co-develop navigation technologies for interventional procedures to improve the care and management of cancer patients. Building on the alliance, the GE Healthymagination Fund, an equity fund that makes investments in highly promising healthcare technology companies, is investing in Veran. The alliance between the two companies reflects GE’s healthymagination initiative, which focuses on reducing cost, increasing access and improving quality in healthcare. Veran manufactures the ig4 navigation system which integrates multi-modality information at the point of patient care in the interventional suite and combines that information with electromagnetic tracking of instruments with imbedded sensors. The ig4 system aims to provide interventional clinicians with the best information at the point when they need it most. GE Healthcare is a provider of comprehensive X-ray imaging solutions that give clinicians the tools they need to take image-based diagnosis and minimally invasive therapy to a new level. The strategic alliance between the two businesses combined with expanded capabilities in product research and development will accelerate the development of innovative high-value integrated technologies for the diagnosis and care of patients suspected of cancer. DBT launches online system ePromis The online system, ePromis, launched in September, 2011, by the Department of Biotechnology (DBT), Government of India, has been developed to enable the submission of the various proposals online and also facilitate tracking of the status of the same. This online system will also provide guidelines for submission of technical reports, annual reports and various financial details required for releasing the grants. Besides providing the user friendly system for online submission of proposal and various other documents related to ongoing projects, it also provides information about the status of the proposal and the status of the project. The other objectives are to enable online peer review and processing of proposal to facilitate complete monitoring and project management. The key features of this system include the online registration for new investigators, online availability of user manual, various forms, online access to proposals for review, online proposal evaluation, reduction in time lag and paper work at various stages of processing. Besides that, the principal investigators of the ongoing and completed projects will have login ID and password to track the progress on their project. This kind of initiative by the DBT can be seen as a major step forward towards the implementation and timely completion of the various projects funded by it across the country. Praxair expands base in Western India Praxair India, a subsidiary of Praxair, plans to construct a new state-of-the-art air separation plant in the rapidly growing Pune-Mumbai industrial corridor of western India. The plant, with a capacity of 300 tons per day, is located 60 kilometers from Mumbai, at an industrial estate near Kalyan. It will supply liquid oxygen, nitrogen and argon to customers in the Maharashtra and Gujarat regions, the largest and fastest growing merchant market in India. The plant is scheduled to begin operations in late 2012. Aurobindo signs pact with Russian firm Aurobindo Pharma, the largest active pharmaceutical ingredients manufacturer under FDA-approved facility from India, through its investment holding subsidiary and OJSC DIOD, a Russian manufacturer of ecological healthcare equipment and nutrition supplements through its investment holding subsidiary (Diod), announced the establishment of a joint venture in Russia on a parity basis (50:50). The name of the joint venture is Aurospharma Company. It is established to manufacture and sell the pharmaceuticals in the markets of Russia, Belarus and Kazakhstan. As a part of this cooperation, the JV intends to construct a state-of-the-art plant to manufacture Non Penicillin and Non Cephalosporin Rx generics and other drugs that are categorized as over-the-counter (OTC) products in Russia. Lilly invests in social initiative Eli Lilly has committed $30 million over five years to fight the rising burden of non-communicable diseases in developing nations.Lilly is launching The Lilly NCD Partnership, which combines the company’s unique resources with the expertise of leading global health organizations, to identify new models of patient care that increase treatment access and improve outcomes for under served people. The partnership will focus on diabetes and, over time, cancer, two core business areas in which Lilly has deep expertise. Lilly and its partners are in the final stages of developing country-specific programs to launch in early 2012. In India, the partnership has been done with, Find Risc Program, Public Health Foundation of India, Project HOPE, and Population Services International. In Brazil, Lilly has tied up with Hospital Israelita Albert Einstein, Diagnostic & Preventive Medicine and Research Institute. On similar lines, in Mexico, a tie-up has been done with Carlos Slim Health Institute and in South Africa it is with Donald Woods Foundation and Project Hope. Chronic diseases disproportionately affect the economically disadvantaged, with 80 percent of all NCD deaths occurring in low- and middle-income countries.  The Lilly NCD Partnership will complement The Lilly MDR-TB Partnership, a highly successful program  launched in 2003 to help address multi-drug resistant tuberculosis, which afflicts some of the poorest people in the world. These programs underscore Lilly’s primary corporate responsibility focus on improving health for people in need, especially in low- and middle-income countries. Agilent introduces world’s smallest FTIR spectrometer Agilent Technologies introduced the Cary 630 Fourier transform infrared spectrometer that offers outstanding performance and reproducibility for routine laboratory analysis of solids, liquids and gases. In addition, the new instrument is the smallest and lightest FTIR spectrometer on the market, creating a significant decrease in the instrument’s footprint in the laboratory. Designed with customer applications in mind, innovative sampling accessories slide in and out in seconds, with no alignment required. Intuitive software allows even novice users to accurately analyze samples in just seconds. The Cary 630 FTIR removes the need to use a liquid transmission cell through Agilent’s unique liquid sampling technology, the DialPath and TumblIR. Waters introduces easy-to-use mass detector Waters Corporation introduced the Waters® SQ Detector 2, a new single quadrupole mass detector, at the 2011 Japan Analytical Instruments Manufacturers Association (JAIMA) Expo. Building on Waters’ long standing expertise in robust quadrupole mass detection and open access technology, the SQ Detector 2 draws on recent advancements in Waters’ performance leading mass spectrometry systems to produce a detector, which is easier to use and compatible with a broad range of chromatographic techniques. Integrated with Waters’ leading chromatographic technologies, the SQ Detector 2 allows users to take advantage of robust, reproducible data from the widest range of experiments available to a single quadrupole mass detector. Shimadzu launches compact UV-VIS spectrophotometers Shimadzu Scientific Instruments has launched the compact UV-2600 and UV-2700 UV-VIS spectro-photometers, which feature advanced optical systems and Shimadzu’s proprietary ‘Lo-Ray-Ligh’ diffraction gratings. The new spectrophotometers substantially reduce stray light, enabling confident and convenient use for routine analysis and demanding research applications. With its double monochromator design and Lo-Ray-Ligh diffraction gratings, the UV-2700 achieves ultra-low stray light of 0.00005 percent T at 220 nm. The need to dilute samples has been eliminated by expanding the photometric performance range to eight Abs, with a transmittance value of 0.000001 percent. This range is set to deliver indutry’s highest absorbance level and ultra-low stray light. Thermo Fisher acquires Intrinsic Bioprobes Thermo Fisher Scientific, the world leader in serving science, has acquired Intrinsic Bioprobes, a manufacturer of unique immuno-enrichment, sample-preparation tools that are used in quantitative mass spectrometry, and enhanced its workflow for biomarker research and diagnostics. The Intrinsic Bioprobes portfolio enables Thermo Fisher to offer its worldwide life science research and clinical diagnostics customers an enhanced solution for quantitative protein biomarker detection. The Intrinsic Bioprobes portfolio includes its novel mass spectrometric immunoassay featuring a patented sample preparation technique. This technology allows enrichment of low-abundance proteins in biological samples. Merck Millipore India awards Merck Millipore has launched the Merck Millipore India Innovation Awards to acknowledge the efforts of scientists for innovative research outside commercial research centers. The announcement was made in New Delhi on September 26. The program, said to be the first-of-its-kind, will recognize exemplary research done by scientists from government-funded and not-for-profit public institutes in the field of life sciences. The three winners will receive certificates of merit and cash rewards of `3 million, `2 million and `1 million, respectively. Dr Marek Dziki, managing director, Merck India, said, “We hope to provide Indian scientists with the necessary resources and recognition to fulfill their research aspirations and enable them to excel.’’ Mr Prantik Mukherjee, head of Merck Millipore in India, said, “The awards program is an apt reflection of our global vision to unleash the potential of science for life.’’ Dr Theodor Dingermann, director of the Institute of Pharmaceutical Biology at the Goethe-University in Frankfurt, Germany, and a member of MMIIA’s scientific advisory board said, “The scientific community in India is amongst the best but often does not have access to world-class resources and facilities like its global counterparts.’’ The deadline for submissions is January 15, 2012. The winners are expected to be announced at a scientific symposium in mid-2012. India pharma market promising: Report The pharmaceutical market in India will be the next significant market by 2020, says OPPI & Ernst & Young’s latest report. The market presents vast opportunities for pharma companies, with successful companies overcoming challenges in the areas of pricing and access to new products and markets, says the report “India emerging: Pharma’s evolving business models”. By 2015, four of the emerging markets are expected to rank among the top 10 global pharma markets, with China and India emerging as the largest gainers. The study has identified India as the preferred choice for outsourcing in the area of late stage drug discovery, shared services and complex manufacturing, while China has been identified as the preferred market for building blocks and intermediates. With an increase in M&A and partnerships, the contribution of emerging markets to the growth of global pharma market has increased five-fold, from eight percent in 2003 to 40 percent in 2010. Further, China and India have emerged as the top two destinations for acquisitions. Mr Ajit Mahadevan, Partner-Life Sciences Practice at Ernst & Young says, “Global MNCs that have entered India have developed a deep understanding of their target customers. They have broadened the range of their products, adopted unconventional partnership models to increase access and tested new pricing and marketing approaches.” New DCGI likely in November With the three month extension given by the Madras High Court to the Drugs Controller General of India (DCGI) Dr Surinder Singh set to end soon, the Government of India is looking for a suitable replacement. The court had permitted Dr Singh to continue as the DCGI only upto October 31, 2011. Therefore, the new DCGI is expected to take over the Central Drugs Standard Control Organization (CDSCO) by November this year. The health ministry, which controls the CDSCO, recently issued an advertisement regarding the recruitment of a new Drug Controller General of India (DCGI) within three months. Earlier, the govt had on June 8, 2011, extended the appointment of Dr Surinder Singh as the DCGI until March 31, 2012. His tenure was to end on June 21 this year. A public interest litigation against his appointment and extension of tenure led to a government order that the period of deputation of a government servant should not exceed beyond five years. Since Dr Singh had already completed five years on deputation, the court took note of the PIL and stayed Dr Singh’s continuation in office. His deputation was extended by three more months again after Additional Solicitor General of India Mr Mohan Parasaran assured the court that the government would speed up the process of recruiting a new DCGI. ]]> <![CDATA[BIO India addresses global BT sector's partnering needs]]> https://biospectrumindia.com/news/95/2879/bio-india-addresses-global-bt-sectors-partnering-needs.html https://biospectrumindia.com/news/95/2879/bio-india-addresses-global-bt-sectors-partnering-needs.html Mon, 10 Oct 2011 17:50:00 +0530 Presence of a large number of international BT and pharma firms reveals the intent of global players to partner with Indian companies. The second annual BIO India International Conference, which was held at the Hyderabad International Convention Center from September 21-22, 2011, came to a conclusion with participants addressing their partnering and networking needs. The two-day event witnessed several biotechnology and pharmaceutical companies from North America, Europe and Asia share a common platform to meet and explore business opportunities with India’s biotech sector. The event saw representatives from 80 Indian firms and 40 North America and Europe-based companies participate in the two-day event at Hyderabad. The event was organized by the Biotechnology Industry Organization (BIO), which represents more than 1,100 biotechnology companies, academic institutions, state biotechnology centers and related organizations across the US and in more than 30 other nations, in association with the Association of Biotechnology Led Enterprises (ABLE), India, and also had the support of the Department of Biotechnology, Government of India. The event featured one-on-one partnering, plenary and panel sessions, company presentations and offered its participants exhibiting and networking opportunities. With the help of these sessions, the Bio India Partnering Conference 2011 facilitated the development of partnerships between the global biotech and pharma industry, and Indian partners, who can provide high-quality contract research, manufacturing and clinical trials support and are looking to partner on discovery and development deals. BIO’s one-on-one partnering tool arranged private meetings between investors, large biotech and pharmaceutical companies and emerging Indian biotech companies. Representatives of global organizations, such as Abbott, Amgen, AstraZeneca, Eli Lilly, Merck, Novartis Pharma, Novo Nordisk, Pfizer, PROOF Center of Excellence, and UK Trade and Investment, were actively scouting for partnerships with Indian biopharma firms. The conference also saw participation from the representatives of law firms such as Cohen & Gresser, and other venture capital companies and research organizations, seeking partnership with Indian companies. Indian companies, such as Biocon, Cellworks Research, Connexios Life Sciences, Dr Reddy’s Laboratories, Glenmark Pharmaceuticals, Lupin, Reliance Life Sciences, Strand Life Sciences and Zydus Cadila Healthcare, also shared their organizational vision and their requirement seeking partners. Additionally, the companies were able to capitalize on this unique opportunity that placed their organization in the forefront of a diverse global audience. Furthermore, the conference included a full schedule of keynote addresses, including that by Mr Glenn Saldanha, chairman and MD, Glenmark Pharmaceuticals and Dr Aaron Schact, executive director, global external R&D, Eli Lilly, on the first day of the event. Day two witnessed keynote address being delivered by Mr Vivek Mohan, MD, Abbott India and Dr Cartikeya Reddy, senior VP and head, biologics, Dr Reddy’s Laboratories. Uncovering thoughts The event featured three panel discussions that focused on innovation and financing opportunities in global biopharma and also examined the high-profile deal between Pfizer and Biocon. The panel sessions also brought to light the latest issues and trends related to doing business in India. The panel discussions covered topics such as, ‘Cross-Cultural Deal Making-Diving into Pfizer-Biocon’, ‘Beyond Outsourcing – Uncovering Innovation in India’, and ‘Strategic Roadmap for India: A Discourse Among Global Pharma Executives’. Mr Viren Mahurkar, executive VP, head of strategic advisory and capital markets, ICICI Securities; and Mr Matthew Walker, VP of operations, specialty and biotechnology operating unit, Pfizer, engaged in a candid discussion on ‘Cross-Cultural Deal Making,’ moderated by Dr Arun Chandavarkar, COO, Biocon. Panelists shared their view points on different aspects of deal’s structure, the collaboration’s progress and the dynamics of cross-cultural deal making. The panel moderated by Mr Glen Giovannetti, global biotechnology leader, Ernst & Young, discussed what is being innovated in India’s biotech labs. Dr Mallikarjun Sundaram, president and CEO, Mitra Biotech; Dr Suri Venkatachalam, CEO and managing director, Connexios Life Sciences; Dr Vijay Chandru, CEO, Strand Life Sciences; and Dr Sanuj K Ravindran, managing director, Asian Healthcare Management. The panelists discussed about the approach taken by their firms that continue to come up with the most striking innovations and how India’s biotechnology innovation differs from the traditional NME-driven Western innovation. At the panel on ‘Strategic Roadmap for India’, Dr Swami Subramaniam, director, external research and licensing for Merck Research Laboratories, Merck & Co; Dr Anand Gautam, sourcing director, Novo Nordisk; Mr Yetunde Taiwo, senior director, emerging markets, Eli Lilly; and Dr Bala Ganesh Tanjore, head of research, VP-discovery, AstraZeneca, India, discussed the long-term intentions of MNCs and spoke about how global organizations could develop mutually beneficial partnerships with the Indian firms and road maps of the MNCs in India. Mr Sri Mosur, CEO, Jubilant Biosys, moderated the panel discussion. The event highlighted the willingness of the international pharmaceutical and biotechnology companies to work with Indian companies and also revealed the interest among the Indian companies to collaborate with global firms. The success of the second edition of the Bio India International Conference has encouraged the organizers to hold the next edition of the event in 2012 as well. Although officially the date of the next Bio India International Partnering Conference is yet to be revealed, it could be expected to be held during the month of September in 2012 again, at Hyderabad. Need for better reforms The US Indian Industry Dialogue, a roundtable forum that brings together key representatives from the US and Indian biotechnology industry with US and Indian government observers, met for its second annual meeting at the BIO India International Partnering Conference in Hyderabad to discuss issues of common interest. Organized by BIO and ABLE, the event also saw participation from representatives of the Association of Contract Research Organizations, India; the Indian Society of Clinical Research and members of academia. The US Indian Industry Dialogue agreed that the lack of clarity and consistency in clinical trials regulations is a significant barrier to R&D commercialization and investment for both innovative and generic medicines in India. Conducting clinical trials is critical for introducing affordable medicines as well as for fostering innovation in developing novel medicines for neglected, chronic and tropical diseases in India. It will also create valuable clinical data for tailoring therapies for the Indian population. Furthermore, therapeutics, which have been developed in India, are likely to be safer for the Indian population. It was decided to jointly develop a white paper that outlines areas of concern as well as recommend measures to ease the difficulties faced by the industry to promote innovation. — Saptarshi Chaudhuri in Hyderabad ]]> <![CDATA[Lisaline to grow at 12% this year]]> https://biospectrumindia.com/news/95/2647/lisaline-to-grow-at-12-this-year.html https://biospectrumindia.com/news/95/2647/lisaline-to-grow-at-12-this-year.html Mon, 10 Oct 2011 17:47:00 +0530 INTERVIEW Mr Ajit Tamhane, Director, Lisaline Lifescience Technologies, India Looking at the growth in the biopharmaceutical industry in India during the mid 1990s, Mr Virendra Tipnis, who was then heading Thermo Electon LLS India as its managing director, established Lisaline Lifescience Technologies in 1996. The company offers customized solutions for cold chain monitoring for segments like pharmaceutical companies, diagnostics and pathology labs, blood banks, the hospital sector, food processing, packaging and the distribution industry. Over the years, Lisaline realized the scope in business of cold chain management for temperature-sensitive products in healthcare and the food industry. With the changing environment and needs of the customers, the company is now looking at launching two products in the current fiscal in India. Mr Ajit Tamhane, director, Lisaline Lifescience Technologies, gives an overview of the company's business in India while speaking exclusively to BioSpectrum. Q Brief us on Lisaline's business approach for the biopharmaceutical sector in India? The challenges in controlling cold chain breaks were serious. One of the key issues in cold chain management in the biopharmacetical sector was, and still is, the proper monitoring of entire supply chain from the beginning till the end. Hence, Lisaline decided to enter into the business of cold chain monitoring solutions. Our strategy is to offer solutions from production until consumption. Lisaline's order booking in 2010-11 was close to `38.19 crore ($8 million) and growth rate of the company is 10 to 12 percent. Q What innovative technologies and solutions has Lisaline introduced in India? We have introduced various technologies to our customers covering vaccines, biotech, research and laboratory, like product monitoring solutions that include a range of indicators from Temp Time Corporation, US. The Vaccine Vial Monitors were used for the first time in 1996 for oral polio vaccine (OPV) and now are being used for all the EPI vaccines. The second area is facility monitoring solutions. Lisaline installed the first wireless real time data-logging systems from Oceasoft France in 2003. It has successfully completed projects of monitoring multi-locations as well as transportation of vehicles through integrated wireless solution. To cater to the need of insulated packaging, Lisaline introduced Airliner, an insulated packaging for the next generation from Coldpack, France, used for transporting test samples, blood units, vaccines and biologicals at the right storage temperature. Q How is Lisaline looking at expanding in India in terms of manpower, infrastructure and money? Lisaline is expecting a growth of 12 percent this year. We are increasing our manpower, especially in the technical support department. We are establishing an assembly line for making customized temperature indicators and making insulating bags for biotech, hospital, blood bank and vaccine customers. A calibration lab is being expanded to cater to the additional demand for lab calibration. Q What new products and solutions will Lisaline launch this fiscal? As an extension to our current range, we are introducing a couple of products this year. One of them is dSEAL real time data-logging solution based on GPS and GPRS data transfer from Antaris, The Netherlands. This solution will offer real time monitoring of temperature, humidity, shocks and light for transportation vehicles. Currently, we are conducting trials with premium logistic service providers and pharma companies across India. The second product is ITAG, small PDF data monitors, that are used to analyse temperature of small shipments, palates without any downloading devices. - Nayantara Som in Mumbai ]]> <![CDATA[Protests against biotech foods]]> https://biospectrumindia.com/news/95/2565/protests-against-biotech-foods.html https://biospectrumindia.com/news/95/2565/protests-against-biotech-foods.html Mon, 10 Oct 2011 17:32:00 +0530 Globally, increasing number of farmers are growing biotech crops every year due to higher returns, but the consumers in Asia are not prepared to bite the biotech foods easily On September 6, 2011, members of Greenpeace, a global environmental organization gave a new dimension to street protests by organizing a big rally in the heart of India's capital, New Delhi, against genetically modified (GM) foods. Hundreds of Greenpeace volunteers, assisted by celebrity chefs from the city turned New Delhi's streets into a kitchen to cook the world's largest GM-free eggplant curry. This was as part of a public campaign which saw more than 100,000 citizens across India signing a petition against the proposed Biotechnology Regulatory Authority of India (BRAI) Bill, 2011, which seeks to set up an independent biotech regulator for the country to provide single window clearance system for GM crops in the country. The BRAI Bill has been in the works for more than a decade undergoing several changes incorporating inputs from scientists, civil society activists, farmers and industry leaders. The protests were held when the legislation was scheduled to be tabled in the Indian parliament in August, but it did not happen due to the then raging anti-corruption movement. The anti-GM group moved in with the public protests once again to build pressure against the adoption of the legislation. There are two fundmental issues agitating the protestors. One, anti-GM activitists believe that the structure of the proposed biotech regulatory body in India will be favorable to the industry and it will pave the way for quick introduction of GM foods in the country. So far, India has allowed the commercial cultivation of only one crop, a GM cotton developed by global agri giant Monsanto. A regulatory approval in 2009 to allow cultivation of GM eggplants has been kept in abeyance by an administrative order. Two, neither the industry nor the government are in favor of allowing a labeling of GM foods whenever it is introduced to provide choice to consumers. Says Mr Kapil Mishra, a sustainable agriculture campaigner with Greenpeace India, â€œPeople have a right to say 'no' to GM foods and that is exactly what they have done today (during the protests). We hope that the government would take notice of the voices of its citizens and stop the introduction of BRAI which would become a non-transparent, autocratic body that will lower the bar for the GM crop approvals.â€? A team of chefs from Le Meridien, New Delhi and Indian Culinary Forum led the cooking of about 342.5 kgs of eggplant curry, which has been certified as a world record by the Limca Book of Records. A portion of the dish along with more than 100,000 petitions was handed over to the Prime Minister's Office by a delegation of citizens. Biotech crops in China China has implemented genetically modified (GM) food labeling since 2004. But there is no clear definition about the labeling procedure. Under Chinese law, the sale of GM foods in China is legal, but manufacturers must disclose clearly on the label that the product is made from GM food. Shanghai Daily recently reported that consumers in Shanghai complained to the local authorities against the manufacturer that they were misled into buying the oil and they were not inclined to buy GM food because of health concerns. Concerned about their health, some 40 people protested against GM foods outside the Ministry of Agriculture in Beijing, according to a news coverage by Global Times on September 13. The report noted that the protesters had signed a joint letter asking the ministry to stop advocating GM staple grains in China. About 80 people signed the letter, including experts and some former government officials. Quoting a top agriculture expert China Daily noted that GM food in China is unlikely to be commercially available for large-scale planting for at least three-to-five years. A GM variety of rice is close to commercialization in China. GM maize is mainly used as animal feed in the country. But the new rice variety must still undergo at least two years of regional trials before it can be approved for commercial planting, under national regulations. Considering the constraints on natural resources in China, particularly land and water, the government will definitely look at biotechnology to raise food production in the long term. Sharing his thoughts at a panel discussion on biotechnology on September 8, moderated by The Wall Street Journal as part of a conference on sustainable agriculture in the Organization for Economic Cooperation and Development, Sir Gordon Conway of Imperial College, London, said he expected China to approve GM crops for mainstream cultivation as early as 2012. He said, â€œThey have got 30-40 (GM crop tests) underway right now.â€? So far, the Chinese government has issued safety certificates for production of eight GM plants, including cotton, rice, maize, tomatoes and sweet peppers. Cotton is the only plant allowed for commercial farming. Contrary to this street protest, the Foundation of Biotechnology Awareness and Education (FBAE), a Bangalore-based non-profit organization started in 2001 to spread biotechnology awareness has been lobbying in favor of the Bill. FBAE asserted that Bt brinjal was safe for human consumption and requested the Prime Minister to intervene urgently to ensure that the moratorium on commercial production of Bt brinjal was immediately lifted. The activists opposing the commercialization of Bt brinjal have asserted that Bt brinjal would seriously affect the use of brinjal in the Alternative and Complementary Systems of Medicine (ACSM) in India, through 'loss of synergy'. Reacting to the voices of protesters, FBAE came up with a special report on the Use of Brinjal in Alternative Systems of Medicine in India. Explaining the highlights of the report, Prof C Kameswara Rao, coordinator, FBAE said that contrary to what was being propagated, eggplant is not used in any Indian system of medicine and hence the claim that Bt brinjal would affect brinjal's use in Indian medicine was aimed at exploiting the lack of scientific awareness of the issue. Scientists, who are in favor of commercialization of Bt brinjal are of the opinion that the moratorium on Bt brinjal was strongly influenced by those opposed to agricultural biotechnology than by credible, critical, and balanced scientific judgment of technologists and biosecurity experts on Bt Brinjal. Says Dr T M Majunath, an eminent agricultural scientist and a former head of Monsanto's India research center, â€œConsidering that the product efficacy, biosafety and environmental safety of Bt brinjal were evaluated for over seven years in India, as per international standards, involving over 200 scientists and more than a dozen public and private sector research institutions, Bt Brinjal should be commercially released without further delay.â€? Field trials in the Philippines Mahyco, the Indian developer of a local Bt brinjal crop, donated the technology to public sector institutes in India, Bangladesh and the Philippines, in 2006, for incorporation in open-pollinated varieties of brinjal for the use of small resource-poor farmers. Sharing of knowledge and experience of the regulation process for Bt brinjal in India could greatly simplify and lighten the regulatory burden in Bangladesh and the Philippines by eliminating duplication of the significant effort already expended by India, thereby contributing to the important goal of harmonizing regulations between countries. In Philippines, Bt eggplant field trials commenced in 2010 in seven sites despite massive protests by farmers and consumers. Of the seven selected trial sites, Davao City, Baybay in Leyte and Santa Barbara in Iloilo, have issued municipal resolutions banning the field trials. The field trials were also conducted in Davao city last October, but the plants were uprooted by the local government to uphold a resolution banning the trials. In June this year, the MindaNews reported that the North Cotabato provincial board has endorsed the field testing of the controversial Bacillus thuringiensis eggplant or Bt Talong without mentioning the date of commencement. The adoption of Bt Brinjal is expected to help millions of farmers by reducing the use of synthetic insecticide up to 77 per cent and losses from the brinjal shoot and fruit borer (SFB), resulting in an increase in marketable yield and reduction of cost of production. There would be about 60 percent consumer benefit as well. A recent publication from India's National Centre for Agricultural Economics and Policy Research noted that Bt Brinjal adoption would add between 30,000 to 119,000 tons to the total production of brinjal, depending upon the extent of cultivation in different states. The absolute annual gain at the country level from Bt brinjal cultivation would be about $120 million at an adoption level of 15 percent, about $240 million at 30 percent and $485 million at 60 percent adoption levels. GM supporters aver that over 25 years of research experience, and more than 15 years of commercial cultivation in about 30 countries have demonstrated that Bt crops are effective and safe for use. The benefits from Bt technology have been amply demonstrated in India by the commercial cultivation of Bt cotton since 2002, which lifted India to the position of second largest exporter of cotton. However, as the street protests indicate, it may not be easy for the Indian government, embattled by a series of corruption scandals, to push through the biotech legislation that easily. - Narayan Kulkarni ]]> <![CDATA[More Bt brinjal trouble for Mahyco, Monsanto]]> https://biospectrumindia.com/news/95/4138/more-bt-brinjal-trouble-for-mahyco-monsanto.html https://biospectrumindia.com/news/95/4138/more-bt-brinjal-trouble-for-mahyco-monsanto.html Fri, 16 Sep 2011 15:57:00 +0530 National Biodiversity Authority has decided to take legal action against Mahyco and Monsanto for developing Bt brinjal by using Indian varieties without prior approval of competent authorities. Both the companies have denied the reports as false and not based on facts Adding another twist to the already complicated Bt brinjal story, the National Biodiversity Authority (NBA), in a meeting held on June 20, 2011, minutes of which were published on August 11, 2011, decided to take legal action against the two major agri-biotech firms, Mahyco and Monsanto, for using Indian varieties of the crop for development of Bt brinjal without prior approval of competent authorities. The authority, meant to govern the use of Indian genetic resources by business and research groups, decided to initiate legal action against the companies for violating the Biodiversity Conservation Act 2002, and using the genetic material from India without mandatory permission. This decision was taken after Bangalore-based NGO, Environment Support Group (ESG), filed a case before the Karnataka Biodiversity Board (KBA) on February 15, 2010, against the companies using Indian varieties without seeking mandatory permissions. ESG has charged several organizations including Mahyco/Monsanto, University of Agricultural Sciences (UAS), Dharwad; Tamil Nadu Agricultural University, Coimbatore; Sathguru Management Consultants (representing the consortium involving the United States Agency for International Development and Cornell University,US) and others, for fundamentally violating section IV and related provisions of the Biological Diversity Act and criminally accessing at least 10 varieties of brinjal in Karnataka and Tamil Nadu without prior and informed consent from the NBA, the state biodiversity boards and applicable local biodiversity management committees. The NGO noted in its plea that such a rigorous process of appraisal was mandatory to protect the loss of biodiversity due to misuse or overuse, theft of biodiversity and to secure biodiversity from contamination when transgenics are involved. In addition, the law mandates that when biodiversity is to be accessed in any manner for commercial, research and other uses, local communities, who have protected local varieties for generations must be consulted and, if they consent, benefits must accrue to them as per the internationally applicable access and benefit sharing protocol. Clearly, the organizations were aware of these laws that were fully in operation when Monsanto and its collaborators initiated research in developing Bt brinjal in 2005. They deliberately chose to side-step conformance with this critical legislation, alleged the ESG. When questioned by the board during the investigation, Mahyco, in its letter dated June 25, 2010, to the board, categorically stated that it was â€œnot in violation of any of the provisions of the Actâ€? and claimed that Bt brinjal was developed by the University of Agricultural Sciences, Dharwad. On its part, the university has claimed, in its letter dated May 17, 2011, that it has secured all permissions from various government departments, but has not produced any evidence of clearance under the Biodiversity Act. The ESG has urged the NBA to initiate criminal proceedings against Mahyco/Monsanto and others in strict conformance with the law. Pending this process, administrative propriety demands that the NBA must suspend action on all applications by any of the agencies involved in biopiracy seeking access to any biological resource of India. This would imply that, the NBA must stop processing Monsanto's application for accessing two varieties of Indian onions. In addition, the ESG demanded that the NBA and its supportive regulatory agencies, such as the state biodiversity boards and biodiversity management committees, must immediately ramp up their capacities to ensure that such acts of biopiracy become a thing of the past. Reacting to the ESG's charges, the KBA sought further information, in a letter dated April 6, 2011, in respect of use of six local varieties of brinjal by the UAS, Dharwad, and those pertaining to the objectives of the agreements between the UAS, Dharwad. Furnishing the details to the KBA, Mahyco informed that it has not violated any provisions of the Biological Diversity Act, 2002. â€œThe public partners have developed their materials with gene access provided by Mahyco in accordance with the regulations governing product development and as per the stipulations of the public funding agencies with whose assistance the public partners are developing the product. Mahyco is neither a beneficiary of the public materials that are developed by the public partners nor has access to their research results. It is reiterated that Mahyco has not indulged in any activity which would be a violation of the Biological Diversity Act, 2002,â€? said Mr Surya Kant Mishra, head of public relations, Mahyco. When BioSpectrum spoke to Monsanto, it said that the company has not received any such information (as on August 17, 2011) directly from the NBA. The company reiterated that the reports suggesting that Bt brinjal was produced by Monsanto or in partnership with Mahyco are untrue and not based on facts. Monsanto also clarified that Bt brinjal has been indigenously developed by Indian seed and biotech company, Mahyco, with the Cry1Ac gene accessed from Monsanto, in collaboration with multiple public sector institutions. â€œWe understand that Mahyco has independently conducted Bt brinjal research for over nine years in full compliance with the guidelines and directives of the regulatory authorities, to ensure its safety by making Bt brinjal the most rigorously tested vegetable with 25 environmental biosafety studies,â€? said the spokesperson of Monsanto. â€œMonsanto is committed to innovating and partnering to help improve productivity for Indian farmers. In over four decades of partnership with Indian farmers, Monsanto has provided high-yielding seeds and biotech traits in corn, cotton, and vegetables; as well as agricultural herbicide products,â€? added the spokesperson of the company. Bt brinjal, which received the nod of genetic engineering appraisal committee (GEAC) for commercial launch in October 2009, suffered a set back when Mr Jairam Ramesh, the then minister for Environment and Forests, put the product under moratorium in February 2010. After this, an independent joint panel of the GEAC and eminent scientists on gene technology favored the lifting of the moratorium at its meeting held on April 27, 2011, and suggested for limited release of Bt brinjal under strict monitoring. It is interesting to note that there was no mention of companies that were not seeking mandatory permissions from the NBA and its supportive regulatory agencies, such as the state biodiversity boards and biodiversity management committees, when the approval was given by the GEAC. The decision by the NBA to seek legal action on the matter has added another controversy to the issue and will delay the research from reaching the farmers and the consumers. Rahul Koul in New Delhi ]]> <![CDATA[Can the drug delivery systems match the pace?]]> https://biospectrumindia.com/news/95/2392/can-the-drug-delivery-systems-match-the-pace.html https://biospectrumindia.com/news/95/2392/can-the-drug-delivery-systems-match-the-pace.html Tue, 13 Sep 2011 14:36:00 +0530 Nandita Singh The author is Editor of BioSpectrum nanditas@cybermedia.co.in Drug delivery innovations will be critical in driving the biomedicine industry. In fact, further progress in biomedicine is dependent on the advances in the drug delivery systems. The market for biological drugs, which is already well over $100 billion, continues to grow at a fast clip, besides getting more complex in nature. Taking these biologic drugs to market and ensuring their quick adoption majorly depends on the delivery systems available. Precision delivery methodologies are required. The question is: can the drug delivery systems match the pace and deliver it? There are many companies working in the area. Applications of technological advances in nanoparticles, microencapsulation, and polymer technology are driving their initiatives. These advances are evolving the drug delivery system itself to work closely with the therapeutic being delivered in a targeted manner with pre-defined time lag release for high efficacy. Drug delivery and the drugs are somewhat getting fused together. This brings forth exciting possibilities. We already have been hearing about needle-free novel delivery mechanisms such as patches and edible vaccines. There are many high potential developments in the offing. In August, this year, South Korean scientists announced that they have developed a nanoparticle anti-cancer drug delivery system. This nanoparticle uses calcium phosphate as a cap to contain the drug, which dissolves only when it comes in contact with the high levels of acidity in cancer cells. Dr Lee Sang-cheon of Kyunghee University led this research group. In another development, a research team at MIT, led by Dr Ali Khademhosseini, associate professor in the MIT-Harvard Division of Health Sciences and Technology, and Robert Langer, the David H. Koch Institute professor, met the same challenge by building micromolds out of a temperature-sensitive material that shrinks when heated. By some rough estimates, the drug delivery systems market will most likely cross $10 billion, globally, by the end of this decade. And that is a huge window of opportunity. Challenges also abound. Science is always a challenge. However, that's not the only challenge. After science, the next big challenge that the companies need to contend with is synergizing these developments at the drug delivery technology companies and research institutes with the companies that need these technologies. And therein lies the next level of challenge in finding ways to collaborate for successful outcomes at various levels. It would be interesting to hear stories of such collaborations, challenges met and the consequent gains. So, I am opening a conversation on this page of BioSpectrum. I look forward to hearing from you. ]]> <![CDATA[India's biotech needs an Anna Hazare]]> https://biospectrumindia.com/news/95/2128/indias-biotech-needs-an-anna-hazare.html https://biospectrumindia.com/news/95/2128/indias-biotech-needs-an-anna-hazare.html Tue, 13 Sep 2011 14:23:00 +0530 Science and Technology Minister Vilasrao Deshmukh has won all round kudos for his role as the interlocutor between the government and Team Anna Hazare and the deft last minute negotiations that led to an amicable end to the Gandhian leader's 13-day hunger strike. Deshmukh's name will be associated when the four-decade-old Lokpal Bill (government ombudsman) becomes a reality in the next few months. Ironically, while the nation will soon get a strong ombudsman thanks to Anna Hazare, the disturbances in Parliament over the issue led to yet another delay in the introduction of the long awaited legislation to set up a regulator for the biotechnology sector. The improved Biotechnology Regulatory Authority of India Bill 2011 was slated for introduction in the Lok Sabha on August 17. But now, it will have to await another date with the legislature. Interestingly the BRAI Bill was cleared by the Union Cabinet exactly a year ago, and was slated for introduction in Parliament immediately. Several Parliament sessions later, it still remains a legislation in the making, as it has been for nearly a decade now. As the Science and Technology minister, it is Deshmukh's direct responsibility to pilot the BRAI Bill through Parliament. Will the biotech industry need to create â€œan Anna Hazareâ€? movement to get Deshmukh's attention and use his deft political skills to fulfill the long cherished dream of an independent biotech regulator? With each month's delay in the tabling of the BRAI Bill in Parliament, the pitch againt the legislation is getting shriller. Voices are coming not just from the known anti-GM (genetically modified products) groups but also from many other sections of the society. The opponents see the BRAI not as an impartial regulatory but a key biotech promotion agency. Their reasoning: the BRAI will be administered by the Department of Biotechnology, which has the mandate to promote biotechnology in the country. The government and biotech industry have not done a good job so far of explaining the importance of the independent regulator for biotechnology and the long term beneficial effects of the technology. The anti-biotech groups are yet again winning the battle for public attention. Will the Anna Hazare campaign make the government look at regulatory agencies in a new light is a moot question. The instincts of the government so far have been to pack all regulatory agencies with bureaucrats and technocrats. The proposed BRAI set up will be no different. The five-member authority will have a chairman, who has to be an eminent scientist, two full time expert members and two part time members. In principle, this is good. But it is the selection process that just like the Lokpal Bill that raises the hackles of its opponents. Members of the BRAI will be chosen by a seven-member selection committee, headed by the cabinet secretary, four secretaries ( health research, agriculture, biotechnology and environment) and two eminent biotechnologists. Typically, the two outsiders chosen for such a committee would have had long stints in the government. So, the selection process will usually be skewed towards the political (government) nominee. The Authority will be assisted by a 15-member advisory committee that can have some experts from outside but here too the majority will be drawn from within the government. This is the crux of the matter. Narayanan Suresh Chief Editor sureshn@cybermedia.co.in ]]> <![CDATA[India CROs: On the fast track]]> https://biospectrumindia.com/news/95/1816/india-cros-on-the-fast-track.html https://biospectrumindia.com/news/95/1816/india-cros-on-the-fast-track.html Tue, 13 Sep 2011 14:18:00 +0530 This financial year has seen some positive developments in the Indian CRO industry, yet the regulatory environment and lack of trained inspectors continue to be areas of concern for companies operating in India. A BioSpectrum special report on the emerging trends in the CRO market in India. Inside: Key findings of Asia Pacific CRO Survey The clinical trial industry in India is undergoing a positive metamorphosis. It is gradually being viewed as a drug discovery rather than a mere drug development destination, with more companies looking at innovation. According to the BioSpectrum-ABLE annual survey 2010-11, the Indian CRO industry has been growing at a rate of 23 percent and clocked total revenue of 3,245.97 crore ($709 million) in 2010-11, over last year's (2009-10) segment revenue of 2,639 crore ($576.4 million). This constitutes about 19 percent of the total biotechnology industry revenue for the fiscal. The players operating in the Indian segment include multinational CROs that still dominate the nation's market, Indian CROs, multinational pharmaceutical companies and Indian pharmaceutical companies. While the first three categories of companies are into global trials, Indian pharmaceutical companies usually look at conducting local trials. The major global players with a presence in India are Quintiles, PPD, Parexel, ICON, Pharmanet, Kendle, i3 Inventiv, Theorem Clinical Research (formerly called Omnicare Clinical Research), Inveresk Research, MDS and SCIREX. Some of the India CROs going global Sl. No. Name of company Countries targeted 1 Synchron Vietnam 2 Siro Clinpharm South East Asia (Malaysia) 3 Veeda Clinical Research South East Asia (Malaysia) /USA 6 Max Neeman Global regions not disclosed 7 Excel Life Sciences Worldwide 9 CliniRx US/Europe The major Indian players in the market are Siro Clinpharm, GVK Bio, ClinInvent, Ecron Acunova, CliniRx, Asian Clinical Trials, Jubilant Clinsys, Vimta Labs, Lotus, Lambda Therapeutics, Clinigene, Max Neeman Medical and International, Synchron Research, Diagnosearch Life Sciences (earlier called iGate Clinical Research), Veeda Clinical Research and Actimus Biosciences. Compared to the previous two fiscals, when the CRO industry was hit by the global economic downturn, the year 2010-11 saw some positive developments in this segment. Both the companies and the Indian government (the Drug Controller General of India or DCGI) were proactive in creating a favorable environment for clinical trials, while consolidation in the global landscape, in the form of mergers and acquisitions, too had its cascade effect on the India CRO industry. Favorable trends and developments According to market observers, the decade-old India CRO industry has successfully overcome early challenges, including the 2008 slump, to report decent growth figures. â€œIt has crossed the early challenges of setting up and establishing of businesses and successfully managing trials,â€? said Dr Arun Bhatt, president, ClinInvent. â€œNow, it has to sustain and grow in a challenging environment.â€? While lower costs has been a crucial factor in making India an attractive destination for global companies looking to conduct large-scale trials, there are other factors like skilled and knowledgeable investigators and expertise, increased compliance towards quality issues, a large patient pool and unmet medical needs of the population also help to lure foreign companies. â€œThe focus areas are cardiology, endocrinology, anti-psychiatric, respiratory, diabetic and anti-infection drugs,â€? said Mr Anil Panwar, CEO, Fortis Clinical Research. Another favorable trend is the CROs engaging in new business development and expanding their range of services. Dr Yati Chugh, managing director of Lotus Labs, Bangalore, said the growth trend was particularly in the areas of data management, pharmacovigilance and clinical trial management. â€œUntil 2000, none of the companies were really offering these services, so these areas need a lot of investment,â€? he said. Dr Ajit Nair, president, Asia operations, Siro Clinpharm, expressed a similar opinion. â€œThe fields of data management and medical writing have seen a significant increase in the country. There is a trend of significant amount of work related to data services going to the BPO sector of big IT companies,â€? he said. Mr Sudip Sinha, vice president and country manager â€“ India, CliniRx Research, too pointed out that the CROs were approached for end-to-end study and program management rather than sponsors outsourcing individual activities to different CRO players. Contract staffing is also common largely due to problems of recruitment and retention of experienced clinical staff in the country, with demand outweighing supply. â€œThe average staff attrition rate in firms operating in India is 45 percent,â€? said Dr Chugh. Home-grown CROs are also aggressively looking at expanding to other markets. â€œIndian CROs are looking at South East Asian countries to expand their operations followed by East European nations. They are focusing on oncology, diabetes, CNS and respiratory as their key therapeutic segments. The Indian arms of global CROs too have started consolidation,â€? said Dr Nair. Siro Clinpharm, in early 2011, launched operations in Malaysia. Veeda Clinpharm too has announced that the final steps were in place for the commissioning of its CRC Veeda phase I unit at Ampang Hospital in Kuala Lumpur, Malaysia. Having established its presence in Thailand, Synchron Research is looking at tapping the growing South East Asian market, with Vietnam being the favoured destination. Increasing clinical trials The number of clinical trials in the country has increased significantly. According to estimates, there are 30 CROs conducting BA/BE trials and 50 CROs looking at phase I-IV trials. Major companies into BA/BE studies are Lambda Synchron, BA Research, Veeda Clinical Research, Vimta, Bioserve, Accutest, Accunova and Lotus Labs. Only a few companies in India are into phase I trials due to issues of large scale investments in infrastructure. â€œThe number of trials are increasing along with the number of job opportunities in this sector. This growth is giving impetus to small CROs that are just starting,â€? said Prashant Patil, manager-business development, Asian Clinical Trials. The Government of India has also initiated a number of steps to create a transparent and favorable environment for clinical trials. In 2009, the DCGI made it mandatory that all clinical trials have to be registered with the Clinical Trials Registry of India (CTRI) before any subject is recruited for the study. As of January 2011, according to the CTRI, the total number of trials registered is 1,584 as against 806 trials between January-December 2010. â€œAs part of the industry's evolution, a good number of phase II and III trials are now being entrusted to the country. Earlier, most of the trials conducted in India were in phase IV,â€? said Dr Chugh. Quintiles India conducts, by far, the largest number of trials in the country. Dr Ramanjaneya, managing director of SMO India, said the overall scenario was good in terms of the number of studies carried out, international companies coming to India and the total investment. â€œFrom the regulatory side, the industry is looking for quicker approvals from the DCGI. Dissemination of correct information about clinical trials to the general public is very necessary,â€? he said. Shortage of inspectors & investigators The most common grievance of the companies operating in the segment is the shortage of trained investigators and inspectors in the country. While data on the total number of inspectors is not available, industry observers said it was not the number but the quality of inspectors that was more important. â€œThe inspectors in India are expected to play superman roles. They are asked by the agency to inspect everything and anything under the purview of the agency. They are expected to inspect labs, manufacturing plants, distributors, ayurvedic companies, cosmetic companies, pharmacies, biotech plants and also CROs,â€? said Dr Shivprakash Rathnam, managing director, Synchron Research Services. â€œFor the good of the industry, there should be a separate wing or department for CRO inspections. They need special training to inspect GCP and GLP compliance in labs. In this way they can control the CRO industry efficiently without any ethical issues.â€? Dr Bhatt also said that inspectors need to spend time in hospitals with investigators to understand how the clinical trials are conducted. â€œThey also need to get an understanding of how monitoring and QA are carried out by the sponsors. The current experience suggests that the inspectors conduct the inspection more like policemen than professionals. The inspectors require training on how to behave professionally as quality compliance experts with the investigators and companies,â€? he said. Inspectors in India also require training on international norms and requirements. â€œIndian CROs are inspected regularly by international regulatory bodies. During such inspections, the Indian inspectors should be allowed to participate as members of the team,â€? said Dr Chugh. â€œThis would help train our inspectors and also bring Indian regulators at par with international counterparts.â€? India still faces the paucity of investigators and lack of sites. At present, a total of 2,000 investigators are overseeing clinical trials across various sites in India. Estimates point out that India requires an additional 25-30 percent investigators. Industry experts said that the way to overcome this challenge is to tap the potential in tier II and III cities and by training investigators on good clinical and lab practices at regular intervals. The regulatory landscape With the global market for clinical trials in India growing, the DCGI is getting more number of applications. Delay and uncertainty in approvals is now the biggest regulatory challenge. â€œThe government should look at ensuring faster approvals as slow pace is one of the main reasons why multinational companies are reluctant to invest in India,â€? says Dr Ramanjaneya of SMO India. â€œIndia is proving to be an attractive destination for conducting trials and the government should understand that and allow for faster approvals.â€? Mr Sinha of CliniRx Research said the delays in approvals were of significant concern in cases where India was a participant in pivotal, global, multi-centric trials. â€œGlobal sponsors tend to include other South East Asian countries to avoid study program delays. The government should look into a multi-tiered approval process,â€? he said. According to Dr Shiva Murthy Nanjundappa, director, CR and BD, Quartesian CR, there should be no cap on the maximum number of approvals. â€œIf they say 10 percent or 20 percent of the projects will be approved, it is unethical. It should be based on the ethical standards and safety and quality of protocols. If all the projects fulfill the need, then all of them should be approved,â€? he said. Theoretically the approval process should take about 12-14 weeks. The time-lines often get extended due to various reasons. â€œThis includes providing rationale for the number of patients to be recruited in India (percentage of patients in a protocol to the global number), providing approvals of western countries participating in the study, and providing justification for age of certain population to participate in studies,â€? elaborated Dr Nair of Siro Clinpharm. Lack of regular interaction between CROs and officials from regulatory agencies is another point of concern. Dr Shivprakash Rathnam stated that this kind of interaction was minimal or non-existent in India. â€œThey never understood each other well. Therefore, the CRO industry is suddenly getting a negative feedback and hence is in defensive mood.â€? M&A effects on India The global landscape saw a spree of merger and acquisition (M&A) activities in 2011. The most prominent deal was INC Research's acquisition of Cincinnati-based CRO, Kendle. Before this, INC also acquired Australia-based CRO Trident Clinical Research. Some other M&As saw private equity firm Nautic Partners acquire Omnicare CR in April, Clinipace Worldwide buy Swiss CRO PFC Pharma Focus in May and private equity-owned inVentiv Health's acquisition of PharmaNet. There are two schools of thoughts on the cascading effects of these M&As on India. On one hand, experts said this could, to some extent, lead to consolidation in the Indian industry. â€œConsolidation was expected and is happening. It is good for small players as they may not be able to sustain the competition,â€? said Dr Nanjundappa. Consolidation will not just expand existing operations but also give CROs opportunity to gain experience. â€œThese are really interesting and will surely help the industry to consolidate its business interests. Besides that, the industry will gain experience and maturity in the long run,â€? said Mr Panwar of Fortis Clinical Research. Mr Prashant Patil of Asian Clinical Trials agreed that M&As bring with them the necessary expertise that can boost a company's revenue, especially for those that are not doing well. â€œSo, on the whole they do help the industry although they create tougher competition for smaller CROs,â€? he said. It has made the market more competitive. â€œDue to consolidations and M&A activity in recent times within the clinical research industry, the spirit of competitiveness is more as is the focus on watching over the shoulder on what competitors are doing,â€? said Mr Sinha of CliniRx Research. On the flip side, another school of experts said that these M&As could impact the existing R&D programs, which in turn will effect the Indian industry to a certain extent. â€œThe major impact of global M&As is a reduction in the number of R&D programs. This has resulted in decrease in the number of phase III trials,â€? Mr Bhatt of ClinInvent said. The trend is quite recent and it will be too early to predict. â€œPost acquisitions or mergers, synergy looks rosier on paper than in practice and a lot will depend upon how both partners navigate their way through myriad issues lying ahead of them, including cultural and personnel issues apart from the financial ones,â€? said Dr Nair of Siro Clinpharm. Clinical trials in India Phases No of trials Phase I 145 Phase II 369 Phase II 792 Phase IV 162 Total 1468 Therapy-wise distribution of clinical trials in India Diseases No of trials Cancer 277 Cardiovascular 200 Central Nervous System 96 Diabetes 211 Metabolic diseases 246 Source: Clinicalstrials.gov (as on August 22, 2011) Companies into drug discovery/BA/ BE studies Sl. No. Companies Studies 1 Vimta Labs BA/BE 2 Synchron Research BA/BE 3 ClinInvent BA/BE 4 TCG Life Sciences Drug Discovery 5 Advinus Therapeutics Drug Discovery 6 Aurigene Discovery Technologies Limited; Drug Discovery 7 Lotus Labs BA/BE 8 Accutest BA/BE 9 Reliance Life Sciences (Clinical Research Group) BA/BE 10 Reliance Clinical Research BA/BE 11 Jubilant Clinsys BA/BE 12 Fortis Clinical Research BA/BE Life sciences companies with CRO subsidiaries Sl. No. Principal /Promoter Company CRO 1 Piramal Healthcare Wellquest Clinical Research 2 Ranbaxy/Daiichi Sankyo Fortis Clinical Research 3 Claris Life Sciences Xcelris Labs 4 Intas Pharmaceuticals Lambda Therapeutics 5 Biocon Syngene/Clingene 6 Aurobindo Pharma Axis Clinicals 7 Suven Life Sciences Asian Clinical Trials 8 Alembic Alembic Research Centre 9 Vlife Sciences Novalead 10 TCG Life Sciences Clininvent 11 Reliance Life Sciences Reliance Clinical Research Top MNC CROs in India Sl. No. Company Year of Establishment in India 1 Quintiles 1997 2 PPD 2004 3 Parexel 2007 4 ICON 2005 5 Kendle 2005; now globally acquired by INC research 6 Theorem Clinical Research (formerly Omnicare Clinical Research) 2002 7 PRA 2007 8 Covance 2009 9 Pharmanet 2003; Now Acquired by inVentiv Health 10 ClinTec International 2001 By Nayantara Som (with inputs from Rahul Koul and Manasi Vaidya) ]]> <![CDATA[Modest growth in the offing]]> https://biospectrumindia.com/news/95/1358/modest-growth-in-the-offing.html https://biospectrumindia.com/news/95/1358/modest-growth-in-the-offing.html Tue, 13 Sep 2011 14:16:00 +0530 Mr D A Prasanna Chairman, Ecron Acunova After three decades in Wipro and GE in the CEO's position, D A Prasanna founded Ecron Acunova. He has built companies from scratch and led them to maturity successfully and is acknowledged for his contribution to 'frugal innovation' in healthcare technology. He is an alumnus of IIM Ahmadabad and GE Crotonville Leadership Institute. The contract research market enjoyed 15 percent compound annual growth of revenue for a decade before 2008. Since the 2008 financial crisis, clinical research outsourced services market has undergone a huge change. Global economy faces the 2011 challenge of excessive sovereign debt in the West. Hope of 15 percent growth has receded and the CROs have to learn to remain healthy with a modest growth of five-to-seven percent in the next couple of years. The structure of the CRO market has also undergone a significant change in last two years. Large pharma sponsors have announced strategic relationships with the top five CROs - Quintiles, Covance, Parexel, ICON and PPD - virtually shutting out the large pharma CRO service market for others. This has led to privatization and consolidation in the next 15 of the top 20 CROs. Tufts Center for Study of Drug Development, in a study by Kenneth Getz and Rachael Zuckerman (Anticipating Structural Changes in the CRO Market) in October 2010, showed that the top 20 CROs (average size $1.3 billion in top 10 and $220 million in next 10) accounted for 86 percent of the revenue. This left 14 percent of the revenue for the rest of CROs (average size $3.5million). The interesting aspect is that while the top 20 had a 2005-10 CAGR of eight percent, the small CROs managed to show 20 percent CAGR. To what do we attribute such rapid growth among niche providers at a time when most sponsors are looking to consolidate vendors to establish preferred pricing through longer term multi-service agreements? Most sponsors and CROs concede that demand for highly specialized niche services and unprecedented access to local markets has been strong. Hence, sponsors and major CROs have increased their partnering with niche providers, say Getz and Zuckerman. Ecron Acunova has pursued strategies which have made it a healthy and robust CRO. 'One country niche' is a sound strategy as long as the CRO is one of the top five providers in the country. We started in India in 2005 and soon surpassed the goal. Speed of patient recruitment is a major value sought by sponsors. Emerging markets have attracted sponsors to select countries of Eastern Europe, Latin America and Asia. Amongst these, China, India, Russia and Brazil have been the most attractive from patient recruitment and market growth for pharmaceuticals. Regulators in some emerging markets seek additional studies on local population and do not accept the global phase III data. Vietnam and Russia fall in this category. In country selection for phase III studies, sponsors include the category to avoid additional study. Some regulators accept trial data from select neighboring countries. Japan accepts data of Korea and Taiwan. China accepts data of Korea and Thailand. Due to challenges in clinical research in Japan and China, Korea, Thailand and Taiwan have become countries of interest to sponsors. Our SEA expansion into Thailand (and Vietnam) has been driven by this rationale. Speed of recruitment is not the preserve only of emerging market. We have learnt from experience that some of the fastest recruitments takes place in Germany and Denmark. Denmark, with less than one percent of India's population, conducts more clinical trials than India. High-quality mature clinical research infrastructure, short regulatory time-lines and globally reputed key opinion leaders prompted us to invest in a Nordic CRO in Denmark. Speed to market is determined not by recruitment alone, but by a few other intellectual factors. Getting advice from the regulator (USFDA, EMEA) on clinical development plan in a timely manner makes a regulatory consulting company highly valuable in increasing speed. Adaptive trial design and use of biomarkers as additional endpoint often give early insight speeding up overall development. Another area is molecular imaging biomarkers. A niche CRO with experienced intellectuals is much sought after. Alliance with Amarex CRO of Maryland gave us this advantage by complementing our strength in imaging. Improvement in speed also reduces cost. An example of technology for speed is the use of EDC in trial. It reduces errors, improves early visibility of data centrally making corrective action fast and improves completeness of data. Being the best EDC implementer has its advantage. Deep expertise in boutique therapy attracts sponsors. We are an Asian expert in stemcell trials and global expert in imaging agent trials. In our country strategy, we also look at these expertise attracting investigators and sponsors. Experience in studies for generics, biosimilars and new regulatory pathways is a valued competency in the US. We have built this capability attracting sponsors. Following the 'string of pearls' strategy, we have differentiated ourselves and made focused investment to deliver studies with speed at competitive cost without compromising on quality. Building an expert CRO network in the right countries with acumen and innovation has made CROs like Ecron Acunova enjoy profitable growth. ]]> <![CDATA[Negative activism is a concern]]> https://biospectrumindia.com/news/95/2933/negative-activism-is-a-concern.html https://biospectrumindia.com/news/95/2933/negative-activism-is-a-concern.html Tue, 13 Sep 2011 14:15:00 +0530 Mr Bharat B Doshi Independent clinical research professional The author is an independent clinical research professional with an experience of about 15 years in international clinical research. In his last assignment, he established Kendle's business in India and four other South East Asian countries over the last seven years. Prior to that, he worked with Quintiles in various roles. The Indian CRO industry has undergone incredible changes since its beginning in India. Here is a snapshot of the key trends and current issues concerning the industry. Negative activism: The country has witnessed a significant increase in activism against the CRO industry recently. This activism is more detrimental than constructive. It doesn't have the judiciousness to separate 'right' from 'wrong' or issues like 'interests of human subjects' from a rational scientific drug development for fellow human beings. This one process can make or mar the future of Indian CRO industry. Indian CROs must come together and tackle this challenge in a two-pronged approach by ensuring ethics, quality and integrity and by improving public perception. Regulatory process: Probably a fall-out of negative activism, Indian regulatory processes are still struggling to take an efficient, pro-research approach. Timelines are still unreliable and unrealistic, while additional complications related to compensation, study-related injury and insurance continue to haunt the industry. With all appropriate intentions, our regulatory process seems to be stuck in reinventing the wheel. It is imperative that the industry come together and work with the regulatory authority to take some harmonized actions on these important matters. Developed countries have faced this issue and carved an approach to deal with them and India can take similar steps with necessary modifications. The industry is globally witnessing unprecedented consolidation or maturation. In the last 18 months, 10 out of the top 20 CROs have changed the shape of their business existence. This has happened in the form of mergers, acquisitions and transfer of equity. As an estimate, these global changes have affected about a third of the workforce of the Indian industry. Matters like mergers of SOPs/ WIs, business system integration and organogram integration are important and present themselves in complex forms. While they look great on a macroscopic view, project delivery-related issues affect at subtle yet significant level. The challenge here is to maximize the value built-up in such transactions and it requires a mature approach. Changing organogram pattern: Strikingly different from how they started in India, CROs are now dissecting their processes on functional lines. This is a global process and is presenting itself in India in recent times. This phenomenon is also more specific to multinational CROs, as domestic CROs keep their workforce more versatile. In a segmented functional organization, this gives rise to multiple verticals performing different parts of a contiguous process, yet maintaining separate lines of commands. The challenges involved include identifying and managing areas of gap and overlap. At an individual CRA level, this poses as a significant change when an individual migrates from one organization to another organization where the organogram set-up is different. Lastly, the industry continues to struggle with people issues like lack of experienced resources and, sometimes, more serious issues like work integrity. After about 15-18 years of existence, this should not have been the case but it is. The answer to this lies within the organizations. They must commit to invest in training and succession planning process. Because of the small size of the industry, it will never have enough number of associates. As an industry, we must make (or contribute to make) what we want. One can't depend solely on supply of candidates from outside without the risk of people issues. ]]> <![CDATA[It's time to address new challenges]]> https://biospectrumindia.com/news/95/1047/its-time-to-address-new-challenges.html https://biospectrumindia.com/news/95/1047/its-time-to-address-new-challenges.html Tue, 13 Sep 2011 14:14:00 +0530 Mr Arun Sundriyal Associate director, PPDi The author is associate director, clinical management, for PPD in India. He holds a master's degree in pharmaceutical biotechnology. He has more than 10 years of experience in clinical research and has worked in vast therapeutic areas such as oncology, neurology, dermatology, respiratory, endocrinology, etc. He can be reached at arun.sundriyal@ppdi.com The Indian clinical research industry has enjoyed exceptional growth over the past decade because of the country's large population, speed, high quality and cost considerations for conducting clinical research. And while the industry continues to face challenges, the outlook for the future of clinical research is positive and promising. The contract research industry was virtually non-existent in the country less than 15 years ago, except for a handful of multinational pharmaceutical companies that conducted studies to provide regulatory and medical marketing support to their respective parent companies. Only a few renowned doctors served as investigators for global studies with direct oversight provided by international sponsors. CROs have entered India in the last 10 years and the industry has expanded rapidly. With competition and escalating costs prevailing in the global market, many companies expanded into emerging markets such as India. Major CROs and biopharma companies began setting up clinical operations in the country targeting the large population. According to the clinical trial registry website, since its establishment in June 2007 when it was established, more than 1,800 trials have been registered and initiated. Now, most CROs consider a presence in India key to their overall clinical research and development strategy. Key factors continuing to drive growth today are: High-quality infrastructure and resources, such as well-educated, English-speaking investigators and clinical research professionals. Growing regulatory support from the government and better policies for multinational biopharma, such as 100 percent foreign direct investment (FDI) in the pharmaceutical sector and the exemption of import duties on clinical trials supplies Improvements in intellectual property policy. India offers sophisticated logistics and clinical research infrastructure. There are more than 15,000 hospitals, 900,000 hospital beds and 14,000 diagnostic laboratories across the country. Quality at these locations continues to grow with more than 600 international conference on harmonization/good clinical practice (ICH GCP)-compliant sites now available. In addition, according to the Medical Council of India (MCI) website, more than 335 medical colleges in India are producing 32,000 graduates every year, increasing the availability of qualified talent. Beyond the nation's medical infrastructure, clinical trials are now supported by full service CROs that are drawing from a growing pool of in-country talent to provide aligned services across areas like data management, medical writing, pharmacovigilance, site management, regulatory consultation and global central laboratories. While most CROs now offer integrated services in India, others offer clinical monitoring, project management, regulatory, data management and quality assurance services locally, providing services like central labs and IVRS via support teams located elsewhere. The growth of regulatory services in India has also expanded and now includes clinical trial approval for phase I to IV studies, import license, export no objection certificate, marketing authorization, and regulatory consultation among others. Regulatory teams generally consist of regulatory associates, regulatory managers and a regulatory director. Dossiers are prepared by regulatory associates and reviewed and submitted by regulatory managers and directors. These departments either work under Indian operation or report to global regulatory departments. There are also dedicated regulatory service providers that serve CROs and sponsors. Issues to be addressed The Indian clinical research industry still faces some challenges. Sponsors can experience unpredictable delays during regulatory approval and multiple queries after dossier submission, compensation pay out issues, approval and rejection/queries on documents, which required only notification as per current guidelines like approval of Investigator Brochure (IB) and addition of sites. These issues are a major concern to industry leaders and have been shared with the government. The authorities are taking many steps. For example, a separate chapter of the Drug and Cosmetic Act will be introduced to reduce the risk of liability for sponsors and CROs. Then, Schedule Y will have the following extensions: Schedule Y1- Registration of CROs, Schedule Y2- Guidelines for Clinical Trial Inspections and Schedule Y3- Guidelines for the EC/IEC. The Central Drugs Standard Control Organization is also developing a guideline for clinical investigator certification. Strong outlook Although there has been tremendous growth in clinical trials over the past decade, the issues above may slow down growth in the short term. The Indian government is taking steps to resolve the above issues. These improvements, along with India's advanced infrastructure and massive patient population, will continue to drive growth in the industry over the short and long term. With more than 150 CROs in India today, the market for clinical trial outsourcing remains high. The CRO industry is maturing and remains competitive. It will be further aided by openness and regulatory developments as well as by awareness and education provided by CROs and sponsors. This education will help in addressing ethical issues and in developing an overall positive impression about clinical trials. Clinical research is an indispensable part of the drug development process, and India has a large potential to contribute in this process. ]]> <![CDATA[Veeda spreads its wings abroad]]> https://biospectrumindia.com/news/95/1421/veeda-spreads-its-wings-abroad.html https://biospectrumindia.com/news/95/1421/veeda-spreads-its-wings-abroad.html Tue, 13 Sep 2011 14:13:00 +0530 Mr Binoy Gardi & Mr Apurva Shah Co-founders and group managing directors, Veeda Clinical Research Mr Apurva Shah takes care of the strategic and growth plans along with finance functions of the group. Mr Binoy Gardi is responsible for developing and implementing new services and establishing relationships with the firm's growing client base. Mr Shah and Mr Gardi have received the Bio-Spectrum â€œEntrepreneur of the Yearâ€? in December 2009 and â€œStar CEO of the Yearâ€? by SME â€“ Yes Bank, in October 2010. Veeda continues to build its strengths in the focused area of early clinical development and oncology. Over the last two years, Veeda has expanded in key geographies, namely the US and Malaysia. These acquisitions are extremely interesting as Veeda has created a â€œnew modelâ€? for CPUs. Both models of phase I unit are based on a variable model as opposed to a high fixed cost model. Usually, phase I units have a high level of investment and, in order to generate high return, one needs to have a continuous high amount of work going through the unit. In the US and Malaysia units, Veeda has entered into a partnership (in Malaysia with the Ministry of Health and in the US with a large hospital group and a university hospital), and, therefore, will leverage the infrastructure of the hospitals but will have the exclusive use of a customized phase I unit. Veeda was the chosen partner in both the cases due to its leadership position as an early clinical development CRO. The unit in the US is even more interesting as it will be the first private-public phase I oncology unit in the US. The unit is hospital-based and is in collaboration with a cancer center. This unit will, therefore, have access to many leading investigators from the center. It will mean that we will be able to start phase I oncology trials in 90 days as compared to nine months in other leading phase I units in the US. This saving of time is something that the pharmaceutical industry is looking for. With the phase I oncology unit and our network of 40 oncology medical practices offices in Belgium, India and Malaysia, we can provide pharmaceutical companies a complete offering in oncology. There is no company in the world that can offer this total package from phase I to phase IIa and this puts Veeda as one of the leaders in the field of oncology early phase research. We also have another 12-bed unit within the hospital in conjunction with the School of Medicine. This unit will be focused in conducting phase I studies in non-oncology drugs. This unit is also based in the hospital and gives us presence in the US, we have always wanted. Thus, having phase I units in the US, UK, India and Malaysia gives us a global presence and puts us as one of the leaders in early clinical development. Veeda also has its own C-14 lab that will allow us to conduct radio-label studies for both non-oncology and oncology molecules. There are not many early clinical development CROs in the US that can offer this service. Further, with the FDA requiring oncology products to undergo such type of studies, we see this as a big growth area. ]]> <![CDATA[New markets to strengthen network]]> https://biospectrumindia.com/news/95/1937/new-markets-to-strengthen-network.html https://biospectrumindia.com/news/95/1937/new-markets-to-strengthen-network.html Tue, 13 Sep 2011 14:11:00 +0530 Dr Ajoy Kumar CEO, Max Neeman International Dr Ajoy Kumar is member of Parliament and CEO at Max Neeman International. In his current role as CEO, he is responsible for overseeing the global business operations of the company and is focused on stable growth, client satisfaction and long-term relationships. He is an MBBS from JIPMER, with post-graduate diplomas in business administration, hospital administration and preventive and promotional healthcare. Max Neeman is India's leading contract research services company and unlike many other Indian CROs whose services are restricted mainly to one or other work areas, Max Neeman has the distinct advantage of being a one-stop solution provider to its clients. Established in 2001, Max Neeman has grown by leaps and bounds in the last 10 years. Having conducted more than 250 trials, it has expanded its operational presence in 31 cities of India with more than 170 active sites. Currently, the company has over 450 employees spread across its offices in Mumbai, Chennai, Hyderabad and New Delhi. With globalization becoming the latest mantra for most Indian CROs, Max Neeman also intends to venture into new markets to strengthen its network and expand its services. With the US and Western European market still being our biggest clients, we now plan to enter the Eastern European market. Europe is the second largest pharmaceutical market after North America accounting for more than 30 percent of the global pharmaceutical market. Growth rate in developed markets like Germany, France, Spain, the UK and Italy has been observed decelerating for the last few years, while the developing markets like Romania, Czech Republic and Ukraine have registered a significant increase in the growth rate. Several factors such as growing healthcare concerns among people and increasing prevalence of lifestyle diseases will boost market growth. Also, increased due diligence and compliance with standards lead to cost overrun and delay in new product launches. The game plan for future is to expand aggressively in Asian and European markets via strategic collaboration and acquisitions and to leverage the combined knowledge and experience of Max Neeman to the already existing advantages of conducting clinical trials in India. With the ability to anticipate and respond to industry and client challenges been at the core of our business approach and hands-on experience in various therapeutic areas, we are all set to provide total clinical program development with special expertise in oncology, cardiology, neurology, infectious diseases, and hematology. Focused areas of specialty, unique offerings, customer service and consistent growth in response to customer's demand are the cumulative factors that have helped us strengthen our position in this ever dynamic industry. Priority of Max Neeman is patient first, then customer, followed by employees. If you look after customers and patients, the business will obviously grow. Thus, in its constant quest to become a truly world class organization, Max Neeman continues to deliver service excellence with the highest ethical standards to its customers in developing drugs and devices that have the potential to restore health and save lives. ]]> <![CDATA[Asia Pacific CRO Survey 2011]]> https://biospectrumindia.com/news/95/1880/asia-pacific-cro-survey-2011.html https://biospectrumindia.com/news/95/1880/asia-pacific-cro-survey-2011.html Tue, 13 Sep 2011 14:08:00 +0530 Over the past two years, BioSpectrum Asia has been capturing the key trends in pharmaceutical, clinical and contract research (CRO) organizations in the Asia Pacific region through focused annual industry surveys. For this 3rd Annual CRO Survey, we partnered with CyberMedia Research (CMR), a premier market research firm that specializes in competitive intelligence, advisory and consulting for life sciences, healthcare and IT enterprises, primarily in the APAC region. The BioSpectrum-CMR Asia Pacific Clinical and Contract Research Organizations Survey 2011 points to radical changes to the business model and strategy for outsourcing firms, and to an exciting phase of growth ahead. The outlook for the outsourcing industry is optimistic, with R&D spending being the key variable. The level of outsourcing is set to increase, and strategic partnerships are likely to overshadow the transactional project-to-project approach that has been the norm. In the following pages, we present the results of the 3rd Annual CRO Survey. Highlights Sixty-six percent of our survey respondents operate in the full service CRO category, while 34 percent are in the niche category. The average contract size for CROs in Asia-Pacific is $8.5 million. Most of the enterprises operating in the APAC region are small and medium-sized. The top five therapeutic areas of focus for CROs include oncology, cardiovascular diseases, dermatology, neurology and respiratory. This is in line with the trends depicted in the earlier Annual CRO Survey that pointed out that oncology is the hottest therapeutic area focus for CROs. According to the survey respondents, India and China are the hotspots for patient recruitment and clinical trials. In the APAC region, the concentration of clinical trials is most in phase III. There are some niche CROs operating in other phase I and preclinical research, and some CROs that span across the developmental pipeline. The top priority for 47 percent of the survey respondents is client expansion. This is followed by revenue growth, product development and geographic expansion. Thirty-four percent of the respondents indicated that the revenue of the sponsors is in $101-200 mn range. A majority of the mid and small sponsors originate from APAC region, and predominantly from India. According to the survey respondents in the sponsor category, over the next three years, the outsourcing budget is likely to increase. When assessing a CRO/CMO, the primary and key strategic consideration is quality and reliability. This takes precedence over other critical factors such as pricing, regulatory compliance and productivity. Survey Methodology The survey included a mix of quantitative and qualitative research, administered through email and direct telephonic interviews. The scope of the survey includes multinational, regional and local CROs based in the Asia Pacific region with revenues upto $1 billion. For the first time in our annual survey, we have expanded our scope to include the perspective of the sponsors. The survey includes biopharmaceutical enterprises in the large, mid and small categories. Our survey gathered data from 422 respondents spread across large, regional and small firms in the CRO/CMO industry, and 90 respondents from the biopharma industry. We received responses from 37 respondents in the CRO industry. The survey respondents came from diverse geographies including, India, China, Malaysia, Singapore, Taiwan, South Korea, Australia, Ireland, Scotland and North America. -------------------------------------------------------------- Focus Areas for CROs According to the 3rd BioSpectrum-CMR Asia Pacific Clinical and Contract Research Organizations Survey 2011, 36 percent of the respondents are engaged in both clinical and contract research. Thirty percent of the respondents indicated that they are into clinical research, while another 30 percent focused exclusively on contract research. Four percent of the respondents are engaged in contract manufacturing. Some CROs are operating as a one-stop shop, servicing a full range of early-to-late-stage clinical development projects for their clientele. To differentiate themselves in the crowded market, some of the CROs have developed niche skill sets. Some CROs operate their business through dedicated units that focus on early phase, phase II-III, late phase business units, and also, business units that focus on technical, pharmaceuticals and medical devices business. Most of the clinical trials in the Asia Pacific region are concentrated in phase II, phase III and phase IV trials. Significantly, phase I and preclinical segments are also witnessing some activity. According to 19 percent of the respondents of the Survey 2011, phase III is where the clinical trials are most concentrated. Phase II was cited by 18 percent of the respondents, while phase IV was cited by 15 percent of the respondents. According to 16 percent of the respondents, their clinical work is centered around preclinical research, while another 16 percent have most of their clinical research activity in phase I trials. Over 81 percent of the CROs operating in Asia Pacific have received orders worth $1-10 mn. Ten percent of the survey respondents indicated that they have received orders in the $11-25 mn range, while three percent of respondents have indicated that the contract size received by them is in the $26-50 mn range. Interestingly, six percent of our survey respondents indicated that they receive contracts in the $101-200 mn category. However, Asia Pacific is home to mostly small and medium-sized CROs with small dedicated resources, as indicated by 81 percent of the respondents. For such CROs, it is tough to take up big orders. The lack of resources acts as a hindrance when one considers big orders above $50 mn. -------------------------------------------------------------- Market Opportunity Assessment Eighty-three percent of the respondents of the BioSpectrum-CMR Asia Pacific Clinical and Contract Research Organizations Survey 2011 indicated that the market opportunities would increase for full-service and niche operators, while 11 percent of the respondents opined that the market opportunities would remain the same. Surprisingly, six percent felt that the market opportunities would decrease over the next three years. The survey respondents indicated many different factors for their assessment and confidence in increased market opportunities. Some of the key factors that respondents indicated include: current global economic realities, cost pressure for sponsors, growing regulatory burdens, the daunting challenges of operating in the West, marketplace globalization and significant increase in outsourcing levels. Some of our survey respondents indicated that geographical and market expansion by sponsors is driving the outsourcing trend. According to one respondent’s assessment, the biopharmaceutical industry increasingly recognizes the contribution to global and regional trials across all clinical trial phases by Asia Pacific CROs. The respondent further opined that India and China are expected to be the favored destinations for outsourcing clinical research in Asia and will witness significant growth in the CRO markets. Taiwan, Japan and South Korea are primed for increased CRO activity in conducting phase I-IV clinical trials. According to one survey respondent, the Indian clinical research market is benefiting from an improving regulatory framework that is supported by a rigorous regulatory oversight. This is attractive for sponsors interested in conducting clinical trials in India. To leverage their competitive edge and be successful in the market in the future, both full service and niche CROs need to differentiate their service from others. The key differentiators for successful CROs should include, flexibility, quality, reliability, scientific and regulatory expertise as well as geographical spread. When assessing the key potential trends over the next three years for the APAC market, 36 percent of the respondents indicated an increase in strategic partnerships with biopharma. According to 32 percent of the respondents, business contracts will increase. Eighteen percent of the respondents opined that significant market consolidation will occur and 14 percent indicated that niche CROs would proliferate. Eighty percent of the survey respondents indicated that the Asia Pacific market will consolidate, while 17 percent of respondents were more cautious and predicted that the market will remain the same. According to three percent of the respondents, the market will fragment. -------------------------------------------------------------- Measuring CRO Performance The CROs are optimistic about the opportunities for their strategic growth in the market. Identifying and implementing metrics can help improve and maximize clinical trial performance. Also, metrics provide sponsors with the key they need to work together to run clinical trials efficiently. So, how does the CRO industry measure itself? What are the most important parameters for measuring performance? According to BioSpectrum survey respondents, quality (25 percent) is the most important parameter for measuring their performance, followed by reliability (20 percent), regulatory compliance (17 percent) and pricing (15 percent). According to the survey respondents, quality (25 percent) is the most important parameter for measuring their performance, followed by reliability (20 percent), regulatory compliance (17 percent) and pricing (15 percent) Revenue band Nineteen percent of the respondents of the BioSpectrum-CMR Asia Pacific Clinical and Contract Research Organizations Survey 2011 indicated that they operate in the revenue band of $26- 50 mn. An equal percentage of respondents indicated that they operate in the $16-20m band. Thirteen percent of the respondents operate in the revenue band of $1-5 mn and $6-10 mn respectively. Only 10 percent of the respondents have a revenue size of $101-500 mn, while another three percent have revenue size greater than $ 500mn. Number of Clients More than 60 percent of the survey respondents indicated that the average number of clients serviced by them per year is less than 15. Less then 10 percent of the survey respondents indicated that they serve more than 100 clients every year. Some respondents indicated that they have long-term dedicated relationship with their clients, with repeated, multiple projects for the same customers. In response to a question on the revenue range of the sponsors, 34 percent of our survey respondents indicated that the sponsors are in the $101-200 mn range. While 24 percent of the survey respondents indicated that the revenue range of sponsors is less than $50 mn, another 22 percent serviced sponsors with a revenue range greater than $200 mn. Twenty percent of respondents indicated that sponsors serviced by them were in the $51-100 mn range. -------------------------------------------------------------- Key Priorities for CROs CROs in the Asia Pacific region have benefited tremendously over the past five years from a variety of factors including changing ecosystem, drying pipelines, strategic partnership opportunities with biopharma, diverse therapeutic clinical expertise and vast patient population. As the developed world continues to be enveloped by tough economic conditions, and the product pipelines of pharma enterprises are shrinking up, Asia Pacific CROs are gearing up to increase their presence globally and leverage their competitive advantage. According to 47 percent of those polled by the BioSpectrum-CMR Asia Pacific Clinical and Contract Research Organizations Survey 2011, client expansion is the most important priority for their enterprise. CROs are working with a diverse set of clientele across geographies including industry, government and academic research institutions. Apart from clients in North America, CROs in the Asia Pacific region are focusing on Europe. Top five focused therapeutic areas Therapeuticareas By percentage (2011) Oncology 64.50 Cardiovascular diseases 23.33 Dermatology 11.11 Neurology 17.86 Respiratory 15.38 Revenue growth is the key priority for 30 percent of the survey respondents, while according to 11 percent of the survey respondents, geographical expansion is the most important priority. As published last year in the results of the 2nd BioSpectrum Asia Pacific Clinical and Contract Research Organizations Survey 2010, CROs are according priority to both geographical expansion and product development. According to 12 percent of the respondents, product development is the most important priority. CROs are offering geographical expansion and product development as a value proposition for their global clients operating from North America and Europe. Oncology: Top therapeutic area According to the survey respondents, the top five focused therapeutic specializations include, oncology, cardiovascular diseases, dermatology, neurology, and respiratory. For biopharma, oncology continues to be a key growth segment and Asia Pacific with its vast patient pool, lower costs and rapidly developing expertise is an attractive destination for the development of their cancer therapies. According to 47 percent of those polled by the BioSpectrum-CMR Asia Pacific Clinical and Contract Research Organizations Survey 2011, client expansion is the top priority for their enterprise The expansion within the biosimilars market is also fuelling the growth of clinical trials across Asia, with the Indian market getting primed for introduction of new oncology-based biosimilars in the near future. Much of the clinical research in Asia Pacific is centered on oncology. According to the results of the survey, other major therapeutic areas of focus for CROs include metabolic diseases, infectious diseases, pain management, hematology, anti infectives, rheumatology, inflammation and ophthalmology. -------------------------------------------------------------- Patient Recruitment In recent years, a key trend that has emerged is of CROs understanding the increasing size and complexity of clinical trials and addressing one of the most critical bottleneck in drug development – patient recruitment. According to the survey respondents, China (26 percent) and India (25 percent) with their vast population are the two key countries wherein patient recruitments are happening, followed by Korea with 14 percent, and Taiwan with seven percent. Survey respondents also indicated Singapore, Japan, Australia, Thailand and Malaysia as geographies where significant patient recruitment is happening. Monetary benefits for volunteers For volunteers interested in participating in a clinical trial, money is one of the key considerations. The decision to participate in a clinical trial is a complex one. Forty-four percent of our survey respondents indicated that they do pay their volunteers, while 56 percent of the respondents do not pay volunteers. Among the survey respondents who indicated that volunteers were paid, 30 percent indicated that they pay their volunteers less than $50. Forty percent of the respondents indicated monetary benefits in the range of $51-100, while another 20 percent indicated $101-200 as benefits. Significantly, 10 percent of the respondents pay volunteers upwards of $500. Source for all charts: CMR ]]> <![CDATA[The vaccine innovator]]> https://biospectrumindia.com/news/95/4673/the-vaccine-innovator.html https://biospectrumindia.com/news/95/4673/the-vaccine-innovator.html Tue, 13 Sep 2011 13:02:00 +0530 A firm believer in innovation, Dr Krishna M Ella dreams about creating excellence. His return to India was only the beginning of a success story called Bharat Biotech and many other ventures Defying all odds and transforming his ideas into reality, Dr Krishna M Ella successfully created synergy between biotechnology and business. He is the man behind Bharat Biotech International, one of the successful indigenous biotechnology companies of the country. Dr Ella, well-known among the first generation of entrepreneurs in the sector, pursued his early education in India and acquired a postgraduate degree in agricultural sciences with distinction and gold medals. He did his PhD in Molecular Biology from the University of Wisconsin-Madison. After working with Sandoz and Bayer for some time, he moved to the US for higher studies on a Rotary Foundation scholarship. He also received the National Research Service Award from the National Institute of Health, Bethesda, Maryland, US, and became part of the research faculty at Medical University of South Carolina-Charleston, US. It was during his tenure at the university that his mother and wife encouraged him to return to India. â€œI still remember my mother convincing me by saying: 'You have nine inches of stomach to feed. No matter how much you earn, you cannot eat more than this capacity. I assure you, I will not let you starve for a single day. Come back to India, do whatever you like to do, take all the risks possible'. This is how they got me back to India,â€? recollects Dr Ella. After coming back, he and his wife, Ms Suchitra K Ella, founded Bharat Biotech International in 1996 in Hyderabad. The company has since grown to become one of the largest manufacturers of recombinant, viral, bacterial, combination vaccines and bio pharmaceuticals in India. It is one of the largest manufacturers of Indirab (anti-rabies vaccine) in India and a WHO-pre-qualified manufacturer of Revac-B (hepatitis-B vaccine) for supply to UNICEF and the only vaccine company in India to manufacture and supply a preservative (thiomersol)-free vaccine (Revac-Bmcf). Dr Ella, who calls himself a serial entrepreneur, has established six companies, apart from Bharat Biotech, in various other sectors. Firm believer in innovation Dr Ella, who is an expert in plant, human and yeast systems, has more than 30 scientific publications to his credit in peer reviewed academic journals. His expertise in gene expression system has been well acclaimed and demonstrated internationally. Dr Ella said he spends 90 percent of his time in research and development. â€œEvery day, I get one idea and I can't sleep without exploring those ideas. That's my weakness which becomes a strength,â€? says Dr Ella. The second priority is product development. â€œI always ask people not to follow the multinational companies. If somebody is producing by a certain method, do not limit your mind by blindly following the same method,â€? he says. â€œBeing a new company, we can always take high risk and we can always develop alternatives, better strategies, more efficient, and more innovative products.â€? According to Dr Ella, the successful creation and production of a Hepatitis B vaccine was a major achievement. He brought down the price of Hepatitis B vaccination from 1012 ($22) per child to a few rupees. The vaccine, which was then sold at 800 per dose, today costs less than 20 per dose. â€œIt's just because of competition and innovation that the price has gone down. The second important thing we did was the rotavirus vaccine programme. We are now bringing global attention to the foundation. It is for the first time that an Indian company is bringing the vaccine to phase III trials,â€? says Dr Ella. According to Dr Ella, affordability should not come in the way of good technology and product quality must not be compromised. Ten years ago, he spotted that the purification method used by SmithKline Beecham to extract vaccine protein was inefficient and costly. The multinational uses till date a technique called ultracentrifugation, in which samples are subjected to 100,000 times gravity to separate the protein from DNA. The equipment cost over 6.9 crore ($1.5 million) and recovered 15 percent of the protein. The technique also uses caesium chloride, which is expensive and has to be completely removed from the final product because it was toxic. The vaccine protein has a phospholipid tail that is electrically neutral, unlike most of the yeast proteins and DNA, which carry an electrical charge. Dr Ella devised a method called the Himax technique in which the vaccine protein can be made to precipitate out of the solution onto a special matrix, while all the charged molecules stay put. Bharat Biotech has since started manufacturing other products, such as a typhoid vaccine and an antibiotic for use against staphylococcus bacteria. We got into rotavirus vaccine programme when the product was being sold from the US market. I said this was a problem of this continent and not a US problem. Two lakh children is a big number. If I can save about two lakh lives per year, I will have achieved my mission of being a citizen of this country - Dr Krishna M Ella Dr Ella was instrumental in creating India-made, single-dose vaccine, HNVAC, when many thought that he was wasting his time and that India should copy rather than innovate. HNVAC is the only flu vaccine to be manufactured through cell culture in the developing world. â€œHNVAC was tested extensively in one of the largest phase I, II and III clinical trials for flu vaccines in India and has proved to be safe and was well-tolerated. The key benefit of our cell culture vaccine is its potential to scale up and produce large quantities quickly as required. It also has a much more sterile and faster production cycle, without the external dependence on eggs, thus enabling quicker response times, in the event of a pandemic,â€? says Dr Ella. Dr Ella is part of various government and industry committees on biotechnology, including the Five Year Plan-Biotechnology of the Government of India, and advisor to many state governments. Addressing key issues Dr Ella said it was important to go beyond biogeneric and biosimilars business model and move towards innovation and research. According to him, companies following on the footsteps of generic model of pharma, will eventually become sick and get acquired. â€œBesides this, in a biogeneric model, we have competition from China, Argentina, Korea, Cuba and a lot of countries who are ahead of us in this model. Biogeneric model will be wiped out after five years,â€? he says. â€œWe never wanted to be a biogeneric or biosimilars company. Our pursuit was always to move away from this and find solutions and build an eco-system to be innovative and encourage creation of IPR. Giving back to the society is equally important for an organization.â€? He said unlike many others, India was important to him. â€œFor me, what's important is, whether I could solve the problem of this continent? For instance, two lakh children die in this country every year because of rotavirus as compared to H1N1, which killed about 1,000 people. We got into the rotavirus vaccine programme when the product was being sold from the US market. I said this was a problem of this continent and not a US problem. Two lakh children is a big number. If I can save about two lakh lives per year, I will have achieved my mission of being a citizen of this country,â€? says Dr Ella. He has a lesson for the entrepreneurs looking forward to start business in this area. â€œFor companies to be innovative and risk-taking, they need comfort at early stage of entrepreneurship and innovation as the incubation period is the most challenging time and hard to maintain,â€? he cautioned. Marching ahead Bharat Biotech has now the country's largest manufacturing capacity for making hepatitis-B (10 crore doses), typhoid (five crore doses) and rabies (80 lakh doses) vaccines. The company has invested a significant amount of money on conducting clinical trials of seven of its products. These products include therapeutics and vaccines that are at an advanced stage of development. It has product development projects in varying stages for the vaccines and therapeutics, such as malaria, rotavirus, typhoid, Japanese encephalitis, pandemic influenza, chikungunya, and staphylococcus aureus. The operational team at Bharat Biotech under his guidance initiated a phase III trial in India with THR-100 in patients suffering acute myocardial infarction (AMI or heart attack). He anticipates that the phase III trial with THR-100 will be completed in the second half of 2011. The results of this phase III trial will pave the way for this novel thrombolytic to be filed for marketing approval by Bharat Biotech with Indian regulatory authorities. Rotavac, the first oral rotavirus vaccine developed by Bharat Biotech, is currently under phase III clinical trials. It is one of the first and largest phase III clinical trials in Indian history involving 10,000 infants. The company has invested significantly in the clinical trials with funding assistance from the Gates Foundation and the Department of Biotechnology, Government of India. Besides being a scientist and a businessman, Dr Ella doubles up as a philanthropist too. He feels strongly about healthcare facilities available to Indian people and believes that one has to have a sense of duty and responsibility towards the safety of the people and environment too. To give shape to his beliefs, he established the Ella Foundation to cater to society-driven issues and public health problems. He remembers the day when Dr Bill Gates wrote a letter to him saying that Bharat Biotech was the only company in the discovery business that stood out. Dr Ella has a strong belief that there cannot be separate quality standards for the people in developed countries and the one living in countries such as India. â€œMy dream is to make safe and quality drugs available to every Indian irrespective of their economical background,â€? he says. Rahul Koul in NewDelhi ]]> <![CDATA['India has provided answers to various viral epidemics']]> https://biospectrumindia.com/news/95/5907/india-has-provided-answers-to-various-viral-epidemics.html https://biospectrumindia.com/news/95/5907/india-has-provided-answers-to-various-viral-epidemics.html Tue, 13 Sep 2011 12:58:00 +0530 Dr Altaf Lal, CEO, MSD Wellcome Trust Hilleman Laboratories Dr Altaf Lal is the chief executive officer of MSD Wellcome Trust Hilleman Laboratories, a new enterprise jointly founded by UK-based premier research charity, Wellcome Trust, and US-based pharmaceutical company, Merck, with a not-for-profit mission to develop affordable vaccines for diseases common in the developing countries. In his long and distinguished career, Dr Lal's focus has been on vaccine and immunology research and global health policy. Prior to joining Hilleman Laboratories, he served from 2003-09 as the US health attachÃ© and HHS regional representative for South Asia at the US Embassy in New Delhi. In an exclusive interview with BioSpectrum, Dr Lal speaks about the reasons behind the creation of the company, the uniqueness of the initiative, fundings, future outlook and much more. Q What is the idea behind this programme and the joint venture? Dr Lal: Hilleman Lab was established with the purpose to develop vaccines for developing countries. We identified needs that needed to be addressed and still continue to be unmet. One of these need is the need to optimize existing vaccines. The initiative started four-to-five months ago in October 2010. We chose to start this program virtually with Medicine in Need (MEND), a technology provider in Boston. We are in the process of developing a research lab at the Jamia Hamdard campus. Our plan is to move the entire research program from an external collaborator to Jamia. We are also utilizing the components of the existing vaccine from Merck, which is another external collaborator. All the work is being carried out at Boston. The work is in full swing and is expected to get completed by this year-end. Q How do you explain the uniqueness of this programme? Dr Lal: For the first time, a pharmaceutical company and charity organization are working hand-in-hand. Establishing a unique corporate in a country like India, where excellence in life sciences research has been achieved, we decided to take a different approach as compared to others. This is a separate entity and not part of Merck or Wellcome Trust. We will need many partners to be successful but we felt the initial governance of the joint venture was simplest if focused on two equal partners. The area where nobody has paid attention in the past is that of optimizing the existing vaccines. The four new components in the existing vaccines that need to be optimized include heat stability, easy administration, reduction in package size and affordability. All these attributes combined together will make the vaccine useful from the perspective of the developing countries. The best part will be that there will be no requirements for cold chain and the cost to vaccinate a child also will reduce significantly. Q Please tell us about the operational model and the fundings? Dr Lal: The joint venture focuses on developing vaccines for the developing countries. Hilleman Labs will develop vaccines that can be sold at affordable prices in the world's poorest countries. It will explore a range of business models based on core support, project-specific grant funding and royalties and revenues received from intellectual property generated by Hilleman Laboratories. Any income received by Hilleman Labs will be reinvested to develop and deliver affordable vaccines to people in developing countries. This 50:50 joint venture is a cooperative not-for-profit business model focusing on the immediate needs and the revenues generated will be put back into operations. The target contributions from each of the partners is 333 crore ($72.5 million) for the first seven years. That amounts to 667 crore ($145 million) in total from both sides for the period of initial seven years. Q Which disease areas are being focused upon by Hillman Labs? Which are the other disease areas you will be focusing on? Dr Lal: Currently, we have identified rotavirus as our priority area for optimization. The share holders have pledged that any royalties from innovations will be put back into the operations of Hilleman Labs. Extensive discussions on other priority areas are on and, in the next six months, we will take the final call. However, the criterion remains the same, which is that it should be extremely important for the developing countries. We hope to develop a platform technology for oral vaccines and are also in the process of identifying other priority areas and conduct research to develop vaccines for oral routes. We are currently working to meet the global needs. We have a strategic advisory board comprising eminent persons from all over the world. We want to develop the potential of vaccines to touch millions of lives. Whatever work we do is as per the India requirement, while also keeping other developing countries in mind. Manufacturing companies don't have to necessarily do much, as they will be handed over the dossier on each process that is to be followed. We will definitely look forward to the funding but at the same time, we will not ask for rebates from the government. We aspire that the countries which have grave issues regarding serious diseases should procure these vaccines. Q Are you open to new collaborations with research organizations? Dr Lal: We are open to new partnerships in R&D. When we do phase I and II for optimized rotavirus, we have to do the development and evaluation process. In that process, the government institutes can play an important role. The manufacturing partner will be required once the optimization of the vaccines is through. Q How do you visualize the progress of biotech industry in India so far? Dr Lal: The Indian government is doing the very good work to counter the various diseases. It is visible from the publications in this direction. India has provided answers to various viral epidemics. Few of the major companies, located especially in Delhi and Pune, have done tremendous work in the area. We are keen to make it more affordable and, some time in the future, we will fill the vacuum in the area. We could have gone to Brazil or chosen other countries, but we preferred India because of the many good reasons, including existing rich programs in different research areas, government institutes doing extensive research, and the regulatory environment that is getting better by the day. However, the growth of the industry may have been a bit sluggish. In that context, I believe there might be a limitation in manufacturing and marketing but the progress in research has been tremendous. India and other countries should have harmonized systems. Making vaccines is serious business and these should be tested vigorously. There is a strong need to synergize things and clarity in regulations should be there. Q What is your future vision for the company? Dr Lal: I would like Hilleman Labs to be the best vaccine company in the country. Using the platform technology, we are ready to optimize the existing vaccines to make them easy to administer, pack and transfer, and make it much more affordable. Rahul Koul in New Delhi ]]> <![CDATA[Mission: Lower cost of malaria treatment]]> https://biospectrumindia.com/news/95/1824/mission-lower-cost-of-malaria-treatment.html https://biospectrumindia.com/news/95/1824/mission-lower-cost-of-malaria-treatment.html Tue, 13 Sep 2011 12:53:00 +0530 By utilizing government funding, Jamia Hamdard and Ipca Labs are working on Artemisia annua L plants with high artemisinin (anti-malaria) content through genetic modulation of key enzymes With drug-resistant falciparum malaria continuing to evolve and spreading worldwide, artemisinin-based combination therapies (ACT) have become the centerpiece of global malaria control over the past decade Malaria is endemic in the South East Asian and African countries, where socio-economic conditions of the population are poor and people cannot afford the cost of ACTs. Working in this direction to reduce costs of ACTs, Mumbai-based Ipca Labs, in collaboration with New Delhi-based Jamia Hamdard (a deemed university), initiated a project to enhance the artemisinin content in Artemisia annua L. plants through genetic modulation of the key enzymes. The commercial production by the company at a large scale can help in slashing down cost of artemisinin-based drug therapies in a major way. The project funded by the Department of Science and Technology (DST), Government of India, and Ipca Labs was commissioned under an institute-industry collaborative program. Jamia Hamdard has so far received 97.64 lakh from these agencies as funds for the project. While Jamia has a bigger role to play in the research, Ipca Labs is focused on the use of therapies and their commercialization. The artemisinin is commercially produced from Artemisia annua L. plants with an artemisinin content of 0.01-1.0 percent. The Jamia research team, with the help of Ipca Labs, has developed a novel strain of A annua L. through bioengineering the mevalonate and artemisinin biosynthetic pathways by over-expressing hmgr and ads genes encoding key enzymes of these pathways. The bioengineered strain of A annua had around 160 percent higher leaf biomass and 90.91 percent artemisinin as compared to the mother variety (received from Ipca Labs). Currently, the stability and inheritance of trans hmgr and ads genes in the newly developed strain of A annua L. plants and also the parameters related to growth and yield of artemisinin in this variety are being evaluated. It is being expected that the metabolic engineering approach pursued in this study will lead to the development of novel variety of Artemisia annua L. with artemisinin content more than 1.5 percent. This variety can be patented and released to the farmers for mass scale cultivation and will ultimately lead to higher production of artemisinin. â€œIn my opinion, efforts should be made by government agencies and the biotech industry to run projects on the PPP model. This will facilitate the major projects leading to the development of products, which ultimately benefit the public at large and support the growth of biotech industry. It will also help to increase the knowledge base and the economy of the country,â€? said Dr M Z Abdin, project head, working at Jamia Hamdard University. â€œTo carry out major research projects like the present one, the funds received from the government and the industry are extremely essential. They are used to hire manpower, chemicals, consumables and instruments. These components are important for the successful completion of the project.â€? said Dr Abdin. The way forward Due to the short supply of artemisinin, the cost per treatment course of ACTs (108.70) over conventional antimalarial drugs (4.60) is high. Consequently, the prices of these drugs are subsidized with government funds or with funds obtained from charitable organizations. The subsidy, however, cannot be a permanent solution of the problem. Therefore, the increase in content of artemisinin will surely address the issue. ]]> <![CDATA[Mission: Boost research on stem cells, biosimilars]]> https://biospectrumindia.com/news/95/1624/mission-boost-research-on-stem-cells-biosimilars.html https://biospectrumindia.com/news/95/1624/mission-boost-research-on-stem-cells-biosimilars.html Tue, 13 Sep 2011 12:52:00 +0530 With the help of government fundings, Abexome Bioscience is working towards creating monoclonal antibodies to benefit stem cell research and biosimilars Stem cell research holds tremendous potential for addressing various dreaded diseases. At present, many stem cell markers do not have antibodies available commercially and the only option is to import these at high cost. To overcome this hindrance, Bangalore-based Abexome Biosciences initiated a project to generate a library of monoclonal antibodies (mAbs) against human embryonic stem cells. With dedicated centers for stem-cell research being established in the country, the company aimed to fill these gaps by developing antibody tools that would be required by the stem-cell research community. The project got a boost when the company received 25 lakh from the Department of Biotechnology (DBT), Government of India, through the Small Business Innovation Research Initiative scheme. Abexome is also working on another initiative for developing antibodies and pharmacological assays for common biosimilar mAbs. This work is again supported by the DBT through a combined grant and loan under the Biotechnology Industry Partnership Programme (BIPP) scheme. It received 1.20 crore as funds and believes that this project will have a major impact in fostering development of such mAbs in the country. With these two projects, the company is aiming at offering cost-effective and quality services and products to the research community in academia and industry. The company, which specializes in the production of recombinant proteins, antibodies and immunoassays, was set up in 2007 with the aim of providing core biology solutions in life sciences R&D. It was founded by a team of scientists who were involved in setting up biotechnology businesses earlier. The company is currently engaged with some of the leading pharmaceutical and biotechnology organizations and reputed academic labs in India. One of its antibody clones was recently in-licensed by a global life science solutions company. For the last few years, the company has grown quite rapidly. â€œWe are grateful to the DBT for sponsoring this project. For the phase I of the project, we received a grant from the DBT. We think it is a very unique situation in India with so much support available from the DBT and other government agencies for development of new biotech products and platform technologies,â€? says Dr Sujan K Dhar, CEO, Abexome Biosciences. The way forward Currently, most of the critical reagents for research have to be imported, resulting in delays and increased spendings. Therefore, both the projects being worked upon by teams of scientists at Abexome are unique and hold great importance in cutting down costs. In case of monoclonal antibodies against human embryonic stem cells, the company is expecting to establish the proof-of-concept by developing the first set of antibodies with grant from the DBT and then build on it further. â€œWe have already initiated the work and it would take another six months at least to develop the first set of products,â€? says Dr Dhar. In the project funded by the BIPP on developing antibodies and pharmacological assays for common biosimilar mAbs, the company expects the product to have a good industrial impact and it is expected to hit the market within the next one year. â€œThere is a dearth of high quality indigenous lab reagents and, therefore, to break that barrier we have initiated these projects. With no duty on the products, the cost will be 30 to 40 percent cheaper than the imported ones,â€? said Dr Dhar. ]]> <![CDATA[Mission: Develop technology to fight infertility]]> https://biospectrumindia.com/news/95/8473/mission-develop-technology-to-fight-infertility.html https://biospectrumindia.com/news/95/8473/mission-develop-technology-to-fight-infertility.html Tue, 13 Sep 2011 12:51:00 +0530 The PPP between the Indian Council of Medical Research and HLL Lifecare will lead to commercialization of quick infertility measuring test kits Tripartite agreement for tech transfer of urine based fertility test kit being signed at ICMR headquarters in New Delhi. (From L to R) Dr Mandira Roy, Dr Sanchita Chaudhary, Mr Rahul Bagga, Dr Pooornima Sharma (BCIL), Dr VM Katoch (DG-ICMR), Dr Satyanarayana (Dy DG ICMR), Dr KRS Krishnan (HLL), Dr Sadhana Srivastava (ICMR), Dr Sanjiva D Kholkute (NIRRH), Dr Abi Santhosh Aprem (HLL), Mr VN Babu (HLL) and Dr Ikram Khatkatay (NIRRH). Conquering infertility will not be expensive, tedious and nerve-wracking anymore. This has been made possible by the complex tests that measure the fertility level and pave way for crucial options like test-tube babies that will be non-invasive and more private than ever before. With over 30 million infertile couples in the country and numbers swelling rapidly, HLL Lifecare is launching the first-of-its-kind simple and cost-effective urine-based fertility measuring kits. The Indian Council of Medical Research (ICMR) recently transferred this technology, developed by the National Institute for Research in Reproductive Health (NIRRH), to HLL Lifecare for validation, commercialization and marketing of the test kits. This technology was developed by Dr MI Khatkhatay and Dr Meena Desai of the NIRRH, an institution of the ICMR, in a project funded by the Department of Biotechnology (DBT), Government of India, and technology transfer was done by Biotech Consortium India (BCIL), a technical arm of the DBT. Under the agreement, HLL Lifecare will take up mass production and marketing of the urine-based fertility test kit for measurement of four key reproductive hormones of four principal metabolites. The metabolites in the urine, like estrogen glucuronide, pregnanediol glucuronide, follicle stimulating hormone and luteinizing hormone, can be measured with the kits. Compared to the existing special procedures that are expensive, time-consuming and stressful, the urine-based kit would have four simple and cost-effective, technology-based on enzyme-linked immune-sorbent assay (ELISA). A tripartite technology transfer agreement was signed recently. â€œIt is essential that fruits of public-funded research should reach the society in an affordable manner. Being a central PSU, under the health ministry, HLL is well-equipped for such a mission. That makes the technology transfer agreement more meaningful,â€? says Dr VM Katoch, secretary, Department of Health Research and director general, ICMR. â€œHLL has always been in the forefront to offer affordable and accessible reproductive healthcare solutions for the people around the globe and urine-based fertility kit is part of our endeavor towards this,â€? says Mr M Ayyappan, chairman and managing director of HLL. â€œI hope that this new discovery will put many people, who are at risk of infertility, at ease.â€? The way forward The kits will be commercially available in the market within 24 months. The technology transfer involves global exclusive and perpetuating rights for manufacture, marketing and sale of the kits. There are around four kits that will be launched to address issues related to fertility and in-vitro fertilization. The first kit can be used to monitor ovulation induction therapy and also for in-vitro fertilization program. The second kit will be for the estimation of the metabolite for detection of occurrence of ovulation. The third kit will be used to measure the evaluation of hypothalamic pituitary gonadal axis, a function of the endocrine organ that is situated deep in the brain and is responsible for the formation of the reproductive hormone. The last kit measures LH assay in conjunction with follicles. ]]> <![CDATA[US debt crisis to hit India's life sciences exports]]> https://biospectrumindia.com/news/95/2979/us-debt-crisis-to-hit-indias-life-sciences-exports.html https://biospectrumindia.com/news/95/2979/us-debt-crisis-to-hit-indias-life-sciences-exports.html Tue, 13 Sep 2011 12:49:00 +0530 However, the sovereign debt crisis in the US could lead to the creation of a much-anticipated US biosimilars pathway Standard and Poor's historic downgrading of the US credit rating to AA+ from a AAA towards the beginning of August 2011 did not just make the US policymakers and economists jittery, but also upset investors across the world. As chaos hit the financial markets across the world, Indian investors too hit the panic button wary of the consequences on industries, especially in the export-oriented sectors like IT, textiles, automobiles, pharmaceuticals and biotechnology. Indian exports to be hit The debt crisis could spell bad news for companies involved in export businesses to the regulated markets of the world. The US, by far, is the largest market for exports for the Indian life sciences industry. â€œThe anxiety is palpable given the fact that the US is not only the largest customer for Indian pharma exports, but also one of the most profitable and fastest growing markets in terms of value,â€? said Mr VN Saravanan, assistant vice president â€“ Research, Unifi Capital. According to estimates by the same firm, out of the total pharma exports of $11.6 billion in 2010, 22 percent relates to the US, followed by 16 percent to Africa and eight percent to CIS (Russian) region. The Indian life sciences industry derives substantial revenues from exports especially from APIs and finished dosage forms. Biocon, for example, exports around 80 percent of its statins and APIs and commands over 20 percent global market share. It derives over one-third of its revenues from this business. Today, it caters to regulated markets like the US and Europe and is one of the largest exporters of Lovastatin to the US. Vaccine major Serum Institute of India exports its products to around 140 countries across the world. Concord Biotech, the largest producer of penicillin-G amidase enzyme exports to a number of companies in China, Europe and the US. Concord also produces and exports lovastatin and tacrolimus. For biotechnology enzyme company, Advanced Enzyme Technologies, exports constitute above 50 percent of its total revenues with the US being the largest market for the company. A volatility in these markets could hit their export revenues. â€œOur company has almost two-third sales in global market. We do have some favorable development from the above crisis since the Japanese Yen has reached historically high. Yet sales are a bit affected in the US and Europe. Over all, we may lose few percent growth. Yet we are working on mitigating this risk,â€? says Dr CL Rathi, CEO, Advanced Enzyme Technologies Positive impact on US biosimilar Heavy debt burden could see huge cost cutting measures by the US government. With mounting pressure on the government towards cutting down its federal budget for healthcare, reduction of drug prices is but an eventuality. This, in turn, could be a boon for generic pharmaceutical companies and could also push the envelope towards the creation of the much-anticipated biosimilars pathway in the US. â€œThe positive impact of these government actions could be higher penetration of generics in the pharmaceutical market (especially in the EU) and publishing of biosimilar approval pathway by USFDA (in order to reduce prices of expensive biopharmaceutical products),â€? said Mr KV Subramaniam, president, Reliance Life Sciences. Opening up of the US biosimilar market could mean huge business for biotech companies in India. Between 2012-19, the US market will see patent expiry of blockbuster biotech drugs to the tune of $60 billion. Amgen is likely to be most hard hit with the patent expiry of three of its blockbuster drugs during that period. Amgen's blockbuster drug for anemia Epogen, which had a sale of about 11,600 crore ($2.5 billion) in 2008 will lose its patent in 2013. Other blockbuster drugs such as Neupogen will lose its patent in 2013, while arthritis drug, Enbreal, will lose its patent in 2012. Epogen, Neupogen and Enbrel together account for half of Amgen's total revenue. Indian companies like Dr Reddy's Laboratories, Biocon, Intas Biopharmaceutical, Shantha Biotech, Ranbaxy, Reliance Life Sciences and Wockhardt are already proactive in this space. Cipla has entered into a 50:50 joint venture with a Chinese company for biosimilars. â€œAny price collapse in the US and EU for generic products would significantly impact bottom lines of all industry players as these two markets constitute 75 percent of the global market for pharmaceuticals. The pharmaceutical industry is facing a number of challenges today from several USFDA failed inspections and this is impacting product supplies to developed markets. This crisis may cripple some companies that are hoping to regain the USFDA approval and thus recovering some of the lost grounds,â€? says Mr Subramaniam. Further, any adverse movement of the Rupee against US dollar would impact profitability in case the import/export commitments are not hedged properly. Mr Navroz Mahudawala, managing director, Candle Partners, said few large companies with regulated market sales would be affected. â€œWe would continue to witness contract research and manufacturing services (CRAMS) as a sector being an under-performer. However, most Indian pharma companies have a diversified business model with exposure to several ROW countries (including emerging markets); importantly majority of profits still coming from India. Thus effect would be minimal,â€? he said. On the subject of CRAMS, Mr Saravanan had a different take. â€œWith respect to CRAMS segment, the outsourced manufacturing model is not at risk because US-based innovator companies will need to access quality and cost-effective emerging markets to drive economies of scale and protect their eroding profitability due to entry of generic drug.â€? Universal outlook positive Like the global downturn of 2008, it is highly unlikely that life sciences would be hard hit by this crisis considering that the demand for medicines and healthcare will never diminish. â€œPharma is insulated from such volatility as demand for medicines and care is generally not discretionary, and as a result the pattern of cash generation via medicine sales and cash deployment due to setting up of capacity and access is not cyclical,â€? says Umang Vohra, senior vice president and chief financial officer, Dr Reddy's Laboratories. â€œOn the demand side, within the regulated and emerging markets prices for most medicines adjust rather rapidly post the patent expiration. Also at the moment, most pharma companies are not highly leveraged to be unduly concerned about borrowing and their costs.â€? Analysts also predicted that given the current economic condition in the matured markets, emerging markets like India would see a decent inflow of funds from foreign investors, especially into sectors like healthcare and life sciences. â€œWith the economic conditions worsening in the US and EU again, investors will be wary of putting money in those economies. The emerging market economies, especially India, are in far better shape and their growth targets are not likely to be impacted considerably by the turmoil,â€? says Mr Vishal Gandhi, vice president of life sciences and technology, YES Bank. â€œWe believe that global investors will increase capital flows to India in the near term. As the outlook for healthcare and life sciences in India is very positive, and the sector attracts around five percent of overall PE/funds to India and that is unlikely to change.â€? Nayantara Som in Mumbai ]]> <![CDATA[Innovation to combat tuberculosis in India]]> https://biospectrumindia.com/news/95/2803/innovation-to-combat-tuberculosis-in-india.html https://biospectrumindia.com/news/95/2803/innovation-to-combat-tuberculosis-in-india.html Tue, 13 Sep 2011 12:48:00 +0530 India has the highest number of Tuberculosis (TB) patients with over one-fifth of the world's cases being reported in the country. India has the potential to solve its TB problem with â€œhome-grownâ€? solutions and lead the world in developing innovative TB diagnostics The first line of intervention in any disorder is its diagnosis. But what if there is no exact method for diagnozing the condition? Tuberculosis (TB) falls under the category of such diseases. India adds around two million new cases of TB every year and there is an urgent need for better, cheaper and more efficient methods of diagnosis of the condition. The government has set an ambitious goal of providing universal access to quality diagnosis and treatment to all TB patients and innovative tools and delivery systems are critical for reaching this goal. A conference on TB diagnostics in India: From importation and imitation to innovation, held at the St John's Research Institute in Bangalore on August 25 and 26, 2011, focused on these concerns and discussed at length, ways to tackle TB and improve its diagnosis. The participants at the event comprised entrepreneurs, scientists and government officials, involved in TB research. Briefing about the objective of the conference, Dr Lucica Ditiu, executive secretary of Stop TB Partnership based in Geneva, Switzerland, said, â€œDiscussion between academicians and the industry will further foster development in TB diagnostics.â€? Dr K S Sachdeva, chief medical ofiicer, Revised National Tuberculosis Control Programme (RNTCP), Ministry of Health, Government of india, highlighted the achievement of the Directly Observed Treatment, Short Course (DOTS) program in the country. The program has achieved 100 percent accessibility in India with over 1.5 million patients being treated in 2010. â€œCurrently, the method of detection of TB in the public sector is through smear microscopy using sputum samples, which in addition to being a 125-year-old method, is both tedious and inaccurate. With over half of the TB cases being sputum negative, there is a need for a more sensitive diagnosic tool. People in the private sector, on the other hand, make use of highly unreliable serological tests,â€? he said. Alternatives in diagnosis needed During September 2010, in an unprecedented move, the World Health Organization (WHO) advised against the use of serodiagnostic tests for diagnosis of TB because of its poor performance and adverse impact in case of a misdiagnosis. Despite this, a burgeoning market still exists in India due to lack of regulation and public awareness. Line Probe assays and liquid culture systems are other methods used in diagnosis of TB, but have problems such as inadequate sensitivity and high costs associated with them. Sharing his thoughts on the adverse effect of misdiagnosis through serological tests, Mr Christopher Dye, director, office of health information, WHO, said, â€œCurrently, in 17 out of 22 countries, where the enzyme-linked immunosorbent assays (ELISA) tests are available, are inaccurate. Each extra doctor seen in an effort to diagnose the illness adds 12 days to worsen the condition.â€? He said that the Gene-Xpert system, a new diagnostic tool, was a nucleic acid amplilfication test with a high degree of accuracy and specificty. â€œIt can even detect the multi-drug resistant TB (MDR-TB), which is on the rise due to rampant and unregulated use of TB medication. The rising number of cases of co-infection (HIV-TB) also demand a sophisticated tool, such as Gene-Xpert, for diagnosis.â€? The Gene-Xpert system has been validated by trials carried out around the world, including India, with the RNTCP acquiring the system at a few centers such as Hinduja Hospital, Mumbai; CMC Vellore and Apollo Hospital on a trial basis. However, it remains to be seen if it can be successfully integrated in the RNTCP programme because of the high costs involved. Currently, the cost of a test using the system can range from 1,197 to 1,474 ($26-$32), which makes scaling up of the test very difficult, thus keeping the field open for any cheap and accurate rapid diagnostic test for detection of TB. Mr Ajay Bakshi, associate principal, McKinsey, India, estimated the market potential for TB diagnostics to be around $60-70 million in India. However, these figures do not fully account for the private sector and, hence, the potential is thought to be much bigger. Pointing towards the correlation between the GDP of a country and the amount it spends on healthcare, he said the potential for TB diagnostics was only going to grow upwards. Presenting a perspective from the diagnostic industry, Mr Chandrashekhar Nair, director, Bigtec Labs, Bangalore, said, â€œMoney remains the primary roadblock in the development of new diagnostics. Public grants for pilot manufacturing plants are difficult to get. Also a standard sample panel for testing the diagnostics that can help manufacturers validate the product is not available.â€? Innovation is key Dr Virendra Chauhan, director, International Centre for Genetic Engineering and Biotechnology (ICGEB), New Delhi, said, â€œIn the diagnostic market, developing ways to enhance existing technologies so that they produce cheaper and more accurate products, is innovation. It can also be described as good quality imitation, providing scientists ample scope for development.â€? In light of the social and economic impact that TB has on the general population, many industry representatives called for more public-private partnerships to fuel research in this area. The industry also sought the government's assurance on product procurement after they develop and if they met the necessary criteria. Dr Camilla Rodrigues, consultant microbiologist, PD Hinduja National Hospital and Medical Research Center, Mumbai, said that there was an absence of guidelines which can be followed to develop and market innovation. Dr BV Kumar, founder of XCyton Diagnostics, Bangalore, was of the opinion that both the industry and the academia should have a symbiotic relationship and a proper structure was necessary for the collaboration to proceed smoothly. Call for a regulatory body The need for a stronger, more accessible regulatory body, such as the National AIDS Control Organization (NACO) for HIV-AIDS, which will evaluate and recommend diagnostic tools for the Indian population was also felt by the entrepreneurs who described the lack of clear regulatory standards as a major stumbling block in getting products validated and manufactured. Addressing the need for adequate funding for start-ups in developing diagnostics for TB, Dr Peter Small, deputy director, TB, Global Health Program, Bill and Melinda Gates Foundation, who will now be based out of New Delhi, spoke of the various sources through which entrepreneurs can access funds for the same. Representatives from the Wellcome Trust, National Institute of Health, BIO Ventures for Global Health and United States Agency for International Development were also present who informed the audience about loans and grants available for research in TB diagnostics. Lack of awareness One of the key reasons for the apparent apathy towards tuberculosis has been the lack of information about the seriousness of the condition and alarming statistics associated with TB. The role of the media in disseminating this information in an interesting manner was highlighted in the last session of the conference, where eminent media personalities spoke about the challenges in getting the decision makers and the public to understand the gravity of the situation. The importance of using local media to reach the affected people in remote locations was emphasized. Mr Narayanan Suresh, group editor, BioSpectrum, spoke about the disconnect between the policy makers, diagnostic industry and the public and how media can play an important role in bridging that gap. Dr Madhukar Pai, associate pofessor at McGill University in Montreal and consultant with the Bill & Melinda Gates Foundaton, pointed out that â€œTB remains one of the most neglected diseases and there is a need for it to enter the public consciousness. Diagnostics is only one of the many areas requiring attention and, with the tremendous potential that India has, the hope for a low-cost, accurate and sensitive diagnostic tool for TB lives on,â€? concluded Dr Pai, also co-chair of Stop TB Partnership's new diagnostic wing. Manasi Vaidya in Bangalore ]]> <![CDATA[BRAI Bill hangs fire, industry is hopeful]]> https://biospectrumindia.com/news/95/8460/brai-bill-hangs-fire-industry-is-hopeful.html https://biospectrumindia.com/news/95/8460/brai-bill-hangs-fire-industry-is-hopeful.html Tue, 13 Sep 2011 12:45:00 +0530 The Biotechnology Regulatory Authority of India as a single window system can help in streamlining the regulatory process. Despite being drafted a decade ago, it is yet to see the light of day The Biotech Regulatory Authority of India (BRAI) bill, which is a revised version of the earlier National Biotechnology Regulatory Authority (NBRA) bill, was scheduled to be tabled in Parliament on August 17, 2011, by Mr Vilasrao Deshmukh, who became the fourth Science, Technology and Earth Sciences Minister in the last 18 months. This did not happen due to the disturbances in Parliament over Anna Hazare's fast in support of the Jan Lokpal Bill. Ever since the government came up with the proposal for a new regulatory body in the form of BRAI, which is expected to promote safe use of modern biotechnology by enhancing the effectiveness and efficiency of regulatory procedures, the bill has received mixed reaction with the academia and the industry pushing for the bill while the anti-biotech lobby upping its ante against it. The bill proposes to set up a five-member Biotechnology Regulatory Authority of India, of which two would be part-time members, under the Ministry of Science and Technology. BRAI will take all decisions related to research, transport, import, manufacture and use of organisms and products created through modern biotechnology. All the other institutions proposed as part of the regulatory system like the Inter Ministerial Governing Board and the Biotechnology Advisory Council are all advisory or supportive in nature. The bill also checks the state government's role in permitting open air field trials of GM crops. "Biotechnology offers one way out of this dilemma of growing more with less. With more than 90 percent of India's cotton farmers taking advantage of biotechnology, I would appeal to the government to replicate the benefits to other crops by expediting the process of its creation." - Mr Ravinder Singh, A farmer leader from Punjab "We are committed as an industry to prove the safety of biotech crops and adhere to very robust trial rules laid out by the Government of India. Our compliance to the regulatory processes is complete and sacrosanct. It is certainly great if we have a single window regulator in the country." - Dr Bharat Char, Lead Biotechnology, Mahyco & ABLE-AG member "Extensive studies examining the safety of biotech crops have been conducted by various independent bodies, including the World Health Organization. These bodies have overwhelmingly concluded that there are no adverse effects on human health. It is high time to establish this authority." Mr Bhupen Dubey, Head, Integrated Business, UPL/Advanta and Member, ABLE-AG "As illustrated by the success of Bt Cotton, the benefits are clearly in favor of Indian farmers, whose earnings have improved considerably, commensurated with dramatic increases in cotton yields over the past decade." Dr P Anand Kumar, Principal scientist, National Research Center on Plant Biotechnology (NRCPB), Indian Agriculture Research Institute (IARI), Ministry of Agriculture "We have seen a definite positive shift in the lifestyles of numerous farmers and the changes were clearly linked to increase in their incomes after adoption of Bt cotton. The BRAI can help in decreasing the timelines in the approval of such crops with enormous profits." Dr N Chandrasekhara Rao, Associate professor, Center for Economic & Social Studies, Hyderbad Farmers, who have tasted the success of the Bt cotton crop in India, along with scientists and the agri-biotech industry, came together under the umbrella of the Association of Biotechnology Led Enterprises-Agricultural Group (ABLE-AG) to appeal to the policy makers to expedite the process of establishment of the single-window regulatory authority in biotechnology. They agreed that use of new technologies in agriculture was the only hope for farmers and was a solution to address the challenges of food security. They also emphasized on expeditious approvals of biotech crop trials and commercialization under the existing system, till the BRAI was approved. Favoring the introduction of the BRAI bill, former Environment minister, Mr Jairam Ramesh, who placed Bt Brinjal under moratorium during his tenure in February 2010, had on record said that the BRAI bill would be a huge step forward in maintaining the integrity of environmental assessment processes. â€œI believe that when the bill will be introduced, it will address the concerns that have been expressed by the civil society groups that it will open floodgates for all GM foods. It's just a exaggerated notion of non-reading of the bill,â€? Mr Ramesh said while inaugurating ABLE-AG in August 2010. Expressing objections to the proposed bill, Mr Kapil Mishra, sustainable agriculture campaigner of Greenpeace India, said, â€œThe sly and hasty manner in which the government is trying to table the bill in Parliament, without even putting the draft bill in the public domain for any discussion, is a commentary on the complete lack of transparency and accountability of our government.â€? He expressed shock at the sweeping powers being given to the proposed authority even to override the Right to Information Act 2005. â€œThe BRAI will take away the people's right to information on things as essential as biosafety assessment of GM crops,â€? he said. Greenpeace has urged the members of Parliament not to approve any proposal on a regulatory framework for modern biotechnology and its applications/products that â€œoverlooks biosafety of citizens and the environmentâ€?. â€œInstead the government should table a legislation to protect and enhance biosafety and to ensure democratic processes are adhered to when dealing with issues as important as food and farming in our country,â€? said Mr Mishra. Dr Raghuvansh Prasad Singh, former Union minister for Rural Development and a member of Parliament from Bihar, while stating his opposition to the BRAI bill in Lok Sabha, called it â€œa threat to food safety and a recipe for destruction of agriculture and rural livelihoodsâ€?. â€œThe bill in its current form is a classic case of conflicting interests where the ministry, which is supposed to promote GM crops, has been asked to regulate it for safety.â€? Similarly, Greenpeace noted in its release that Mr Basudev Acharya, CPI(M) party leader in Lok Sabha who found the proposed BRAI objectionable, said that there were â€œnumerous concerns with relation to the health and environmental safety of GM cropsâ€?. Acharya, who is also the chairman of the Parliamentary Standing Committee on Agriculture, further opined in the House that â€œthis bill read along with other legislations like the seed bill, that is up for tabling in this session, shows the government's real intent of siding with the biotech seed corporations against the farmers and consumers of our countryâ€?. The BRAI is expected to be a dedicated authority comprising five members including a chairman. According to the proposal, it will also have an inter-ministerial governing body. There would be three divisions to address the core areas of biotechnology, including agriculture, biopharma and environment. There are enough provisions for public feedback in the bill and also an appellate tribunal (law ministry) to take care of objections. Besides, it is inclusive of experts from agriculture, commerce and other fields. The empowered board is expected to have secretaries from all the ministries including, science, commerce, environment and others concerned. Administrative work will be overseen by an empowered chairman, with a stakeholder forum and state biotech committees present to give ideas. There will be separate bodies to deal with the issue of commercialization of the biotech products and the BRAI is expected to deal comprehensively and credibly with all the issues of biosafety. According to critics, it is not a technology matter but a social issue that scientists often look down upon. Sources in the government told BioSpectrum that the new bill, with many amendments, maintains the integrity of the social issues and public consultation done in different cities last year to seek opinion of the members of the civil society. The successful passage of the bill in Parliament can lead to the establishment of the highest biotech regulatory authority and subsequent streamlining of the prevalent chaos. The biotechnology industry and scientists are pinning their hopes on an early introduction of the bill in Parliament. Rahul Koul in NewDelhi ]]> <![CDATA[Jamia Hamdard launches vaccinology initiative]]> https://biospectrumindia.com/news/95/1659/jamia-hamdard-launches-vaccinology-initiative.html https://biospectrumindia.com/news/95/1659/jamia-hamdard-launches-vaccinology-initiative.html Tue, 13 Sep 2011 12:44:00 +0530 The deemed university, in collaboration with Hilleman Laboratories, will offer a two-year specialized master's course from September this year to meet the manpower needs of the industry. Initially, it will take 15 to 20 students per batch One of the challenges before vaccine manufacturers is the lack of trained manpower. Taking a step forward in this direction to address the demand and supply gap of skilled manpower, Gurgaon-based Hilleman Laboratories, an international research facility sponsored by Wellcome Trust and Merck, UK, signed a memorandum of understanding with Jamia Hamdard (a deemed university), New Delhi, for collaboration in research and academics. In order to facilitate quality research in the area of vaccinology, Hilleman Laboratories and Jamia Hamdard will partner under a 'no profit, no loss' business model to jointly set up a vaccine research facility at the institution campus in the national capital. Under this joint program, called the Hamdard Vaccinology Initiative, the institution will start a two-year full-time specialized master's program in vaccinology from September 2011. Initially, the course will have 15-20 students per batch. The focus areas of the course will be research and development, manufacturing process and regulatory mechanism involved in the segment. Practical know-how and training on various aspects of the vaccine industry will be provided. While the program is expected to start by the end of September this year, the facility will start operating as a professional lab from November 2011. In the first phase, MSD will make an investment of close to 10 crore ($2.1 million). The postgraduate labs at Jamia Hamdard have already been revamped into GMP and GLP environment labs. A 200-square feet area, available with the institution, will be used to build the facility. The institution will have both environmentally-controlled FDA-approved labs and the other labs accessible to students, where replica of fermentation units will help students gain practical knowledge. Besides that, the institution is also planning to have a one-year post-MSc diploma in vaccinology from 2012 with an aim to train students in various aspects of vaccine development and production to cater the needs of the industry. The Department of Biotechnology is the nodal department for these courses. Given the specific requirements of experts in the area (training and practical knowledge), the course is meant to bridge the gap between the supply and demand of the industry. Till now, there was only a 10-day course at the Christian Medical College, Vellore, supported by Department of Biotechnology, Government of India. The course at Jamia Hamdard will be the first full-fledged master's degree course in vaccinology in the country. Talking about the need for such collaborations, Dr G N Qazi, vice-chancellor of Jamia Hamdard, said they wanted to â€œtap the expertise of the people from the industry to provide our students with the best from both the academia and the industryâ€?. â€œResearch in vaccines is only done by a few private companies and a few research labs as there is a scarcity of trained professionals. Through this lab and with the introduction of new courses in the area, we want to develop a pool of human resource at the undergraduate, postgraduate and PhD level,â€? said Dr Qazi. â€œStudents will have good knowledge of lab practices and so they can get into manufacturing or further research in the area of vaccinology. In fact, they will be able to apply their learning to any biotech company.â€? Dr Altaf Lal, CEO, Hilleman Labs, said the course was much needed to fulfill the requirements of the industry. â€œThe course will establish a partnership between the industry and an academic institution,â€? he said. â€œJamia Hamdard was chosen to set up the lab because their core values are related to health systems. In the lab, students will be able to perform practicals through rigorous training programs being drafted for them. India has a huge capacity to develop vaccines. This opportunity will allow us to meaningfully contribute to the institution's vaccination training program. In a few years, we hope that the program will become self-sustainable.â€? Reacting to this initiative, Dr Krishna Ella, chairman & MD, Bharat Biotech, said that such specialized courses were a welcome step and they should be able to help find a solution to the requirements of trained manpower for the industry. The master's program in clinical research at Jamia Hamdard, started in 2009, is already a success with most students finding placements with companies such as Ranbaxy. The focus of the course is regulatory pharmacology, new biologicals and recombinant products for clinical research. The facility at the campus has successfully conducted the bioequivalence and bioavailability of generic drugs. The institution has tied-up with Max Neeman, Fortis CRO and other organizations. Giving attention to practicals, 60 percent of the time of students is spent on hands-on training. After looking at the positive response received by these collaborations, Jamia Hamdard and its partner are highly optimistic about the vaccinology course. In India, vaccines hold an important position in the biotechnology industry with a huge chunk of the population suffering from various diseases. In 2010-11, this segment registered a continued growth of 12 percent and held close to 20 percent share of the overall Indian biotechnology industry's revenue. While claiming the biggest pie in the 10,655 crore ($2.3 billion) biopharma market, the vaccine segment generated 2,441.6 crore ($0.5 billion) as revenue in FY 2010-11 as compared to previous year's figure of 2,180 crore ($0.4 billion). There are about 15 prominent Indian and multinational companies in the segment that manufacture and supply human and animal vaccines in India and across the world. Few of the well-known Indian names include Serum Institute of India, Panacea Biotec, Shantha Biotech, Indian Immunologicals, Bharat Biotech, Biologicals E, Haffkine BioPharmaceuticals and Cadila Healthcare. Besides the local companies, there are multinationals such as GlaxoSmithKline, Pfizer (Wyeth), MSD Pharamaceuticals, Sanofi Pasteur and Sanofi Aventis that produce and supply vaccines in different disease categories. India also has several animal vaccine manufacturing companies including Indovax, Venkateshwara Hatcheries and Indian Immunologicals. Rahul Koul in New Delhi ]]> <![CDATA['Huge potential for ANSYS tools in APAC market']]> https://biospectrumindia.com/news/95/5788/huge-potential-for-ansys-tools-in-apac-market.html https://biospectrumindia.com/news/95/5788/huge-potential-for-ansys-tools-in-apac-market.html Tue, 13 Sep 2011 12:37:00 +0530 Mr Gautam Dutta, Country manager, ANSYS India ANSYS is a global innovator of simulation software and technologies designed to optimize product development processes in the US. ANSYS acquired the Electronic Design Automation (EDA) software with the acquisition of Ansoft in March 2008, and was in the spotlight recently when the Federal Communications Commission (FCC), an independent agency that regulates inter-state and international communications of the US, approved its finite element method for biomedical transmitters. ANSYS has devised simulation testing to assist and reduce costly in vivo and in vitro testing. In an exclusive interview with BioSpectrum, Mr Gautam Dutta, country manager of ANSYS India, elaborates on the company's activities in the field of healthcare and the significance of HFSS software, originally developed by Ansoft, in the medical equipment sector. Q Can you elaborate on ANSYS's ventures into healthcare sciences? ANSYS simulation tools have been used for a number of years in the healthcare sciences. Structural simulation has been used to design prosthetic limbs and help doctors in planning hip replacement surgeries. Fluid simulation provides insight into the design of intravascular stents helping to minimize the risk of neointimal hyperplasia. For electromagnetics, HFSS has been utilized in MRI coil design and simulation of specific absorption rate for cellular and mobile devices. Q How important are the FCC standards for medical devices companies? How does ANSYS fit into this loop? The FCC standards are extremely important. A device that does not pass these standards is not allowed to go to the market in the US. ANSYS tools and HFSS in particular are valuable in this area for understanding the radiated emissions from implantable electronic devices. In addition, the designer can use simulations from HFSS to understand the susceptibility of devices with respect to external sources of radiated electromagnetic fields. Q How useful and significant is HFSS to the medical equipment sector? Who are the potential buyers of this software? The ability of HFSS to provide automated and accurate solutions to any electromagnetic phenomenon makes it an invaluable tool for electronic design. Any wireless medical device, such as the latest pacemakers or hearing aids, can be designed using this software, reducing design cycle time and time-to-market. In addition, the insight provided by simulation allows the designer to understand the robustness of their design in greater detail, which is vitally important for surgically implanted devices. Potential buyers are companies designing wireless medical devices, magnetic resonance imaging (MRI) equipment or electronic equipment that have to pass FCC emission standard. And the issue of passing FCC emission and susceptibility standards is not restricted to surgically implantable devices as covered by the recent FCC ruling but also to any electronic equipment used in the healthcare industry. Q Will this enhance public reach and provide easy access to medical devices? What kind of medical devices will benefit from this software? Reducing the design cycle and time-to-market through simulation brings down the overall cost of design allowing for lower device cost and increased availability. As mentioned previously, any electronic equipment has to pass emission and susceptibility standards, and electromagnetic simulation from HFSS allows deeper insight into this phenomenon. Romi R in Bangalore ]]> <![CDATA['India is the best fit for our first step into Asia']]> https://biospectrumindia.com/news/95/2672/india-is-the-best-fit-for-our-first-step-into-asia.html https://biospectrumindia.com/news/95/2672/india-is-the-best-fit-for-our-first-step-into-asia.html Tue, 13 Sep 2011 12:35:00 +0530 Mr Alastair Gray, managing director, Phenomenex India Mr Bobby Virasingh, director sales & marketing, Phenomenex India Phenomenex, a global leader in the research and manufacture of advanced technologies for separation sciences, has expanded its international subsidiary network to serve India directly from a new head office in Hyderabad. The new entity, which opened in April, will serve research communities throughout India with sales and service teams that would sell all Phenomenex products directly and provide timely technical support, training and seminars. Phenomenex serves research customers in a wide range of industries, including drug discovery and development, chemical processing, biofuel analysis, food and water safety, forensics and toxicology. All Phenomenex products, including the leading Luna, Gemini, Synergi, Kinetex, Strata-X, BioSep, Lux and Zebron brands, will be supplied exclusively from the Indian office to customers in India. In an email interview to BioSpectrum, Mr Alastair Gray, MD and Mr Bobby Virasingh, director of sales and marketing, Phenomenex India, share their views and plans for the Indian market. Q India is your first entry point to the Asian market. How do you see the market in the Asian region in general and India in particular? Phenomenex has been expanding its global operations and presence since 1987. The demand for Phenomenex products throughout Asia has been growing exponentially over the last few years. Given the region's strong potential and customer demand, Phenomenex found that India would be the best fit for our first step into Asia. Being closer to our customers gives us the opportunity to serve their needs. Q What is your investment in setting up direct presence in India and what will be the strength of your operations in India? Out of the 18 Phenomenex offices established, our Indian operation has required the largest capital and human investment so far. The strength of all Phenomenex operations has been the way we have revolutionized the world of chromatography. We constantly expand our research and development efforts to support a wide range of applications in a vast number of industries, from pharmaceuticals to alternative fuels. Producing relevant and innovative technologies that will continue to shape the future of scientific analysis and investigation is the core strength of our R&D team. Q What kind of growth are you looking at from India operations in the next couple of years? We are anticipating India to be among our top growth markets in the coming years. Within the first month of operation, the demand for our products has more than surpassed the projected revenues. The scientific community has been very receptive, and we will continue to develop more resources and hire more Indian talent to support our customers. Q How do you see the market for the range of products on offer from your company in India? In recent years, there has been an increase in demand for our products that serve segments such as liquid chromatography - both HPLC and UHPLC - gas chromatography, solid phase extraction, sample preparation, preparative chromatography, bulk and process media, amino acid analysis, oligonucleotide purification and chiral chromatography to name a few. In all of these product lines, we offer technological advantages which will ensure continued adoption of our technologies in India. Q India already has few players who have been offering technologies for separation sciences. What strategies do you have in place to compete with the existing players in the market? Phenomenex is very unique in its business model and approach to customer care and service. Our existence depends directly on the complete satisfaction of our customers. Therefore, our commitment to providing the highest level of customer satisfaction and technical support will define the difference between Phenomenex and other market players. From ultra fast product delivery, technical troubleshooting second to none, to on-site method development, I am confident that Phenomenex will set new benchmarks for customer satisfaction in the separation science industry within India as it has done elsewhere. Another critical difference is our investment into research and development to continually advance separation science technology. This is reflected in our huge range of separation science consumables, seven R&D100 award technologies, numerous patents and ISO 9001:2008 certified quality. Q Of the range of industries that Phenomenex is serving, which industries according to you, will generate more returns for the company? We serve several industries ranging from pharmaceuticals, life sciences, clinical and forensic toxicology, food safety, natural products, petrochemical-alternative fuels, and environmental among others. Obviously, pharma will be huge for us in India but we expect strong returns in all areas. Q Do you feel India has the right atmosphere for conducting drug discovery research? Enthusiasm and ingenuity are palpable throughout India. This type of atmosphere is ideal for the creative thinking required for drug discovery research. We are honored to work with the scientists in India who continually improve our world with innovative drug therapeutics. Narayan Kulkarni ]]> <![CDATA['13% of our revenue comes from APAC']]> https://biospectrumindia.com/news/95/1606/13-of-our-revenue-comes-from-apac.html https://biospectrumindia.com/news/95/1606/13-of-our-revenue-comes-from-apac.html Tue, 13 Sep 2011 12:25:00 +0530 Mr Syed Jafry, senior VP & president, Thermo Fisher Scientific, Asia Pacific and South America Thermo Fisher Scientific inaugurated its new Center of Excellence (CoE) for chromatography consumables and specialty products in Ahmedabad, Gujarat, to provide enhanced application support for customers working across a broad range of applications, including pharmaceutical, environmental, and food and beverages in the Asia Pacific region. The facility, located in the city's pharma SEZ and spanning across an area of 3,500 square feet is adjacent to the existing Fisher Biopharma Services facility (inaugurated in 2008), which currently has an employee strength of around 70 people. This is the company's first CoE in the APAC region. Mr Syed Jafry, senior vice president and president, Thermo Fisher Scientific for Asia Pacific and South America was in India to inaugurate the CoE. In a conversation with BioSpectrum, Mr Jafry throws light on the importance of this facility in India, the company's strategy for India and the APAC region as a whole. Q Can you give a snapshot of the new chromatography Center of Excellence at Ahmedabad? How important is this facility in your overall APAC strategy? We established our facility in Ahmedabad in 2008, focused on providing clinical trial services, distribution, warehousing and logistics support to pharmaceutical companies. Currently, with investment-friendly policies in India, our customers are expanding their manufacturing capacity as well as investing in R&D. This gives us an opportunity to invest further. Therefore, we have invested in a state-of-the-art application center that focuses on chromatography consumables and specialty products. We have installed mass spectrometry and chromatography systems in this facility that will help us to support our customers in the creation of stringent application development methods, not only in India but also in the Asia Pacific region. This center of excellence will be very closely connected with our Runcorn facility in the UK, from where we will get direct assistance from our specialists and technologists. The initial staffing here will consist of five highly-trained scientists. We will continue to expand the staff over the next 12 to 18 months. The facility will also be used for post-sales support and training. Q Globally, Thermo Fisher Scientific has made some major acquisitions (Dionex and Phadia) recently. What impact do you think these acquisitions have on your APAC business? On the acquisition front, we look at almost every opportunity. But we have a strict list of criteria that needs to be met for us to even consider taking a deal to the next step. They need to strengthen our strategic position, enhance our customer offering and create shareholder value. Around 13 percent of our revenue comes from the Asia Pacific region. Dionex generated more than 35 percent of its revenue from the APAC region. In India, Dionex is strong in pharmaceuticals and in the rest of Asia Pacific, it is well established in the environmental segment. We believe that we can leverage the Dionex position in Asia Pacific, now that we are one company. Phadia too has a strong presence in the Asia Pacific region. Q How bullish are you in segments like specialty diagnostics and mass spectrometry are concerned? Both specialty diagnostics and scientific instruments are growth platforms for Thermo Fisher. In the specialty diagnostics market, we acquired BRAHMS, based in Henningsdorf, Germany, which brought us a portfolio of biomarkers used in the testing of sepsis, cardiovascular and pulmonary diseases. The biomarker testing business is part of a trend towards personalized medicine, which is popular in countries like India and China. We also see opportunity to expand the use of in vitro allergy testing which comes from the Phadia acquisition. Mass spectrometry is a market in which Thermo Fisher Scientific has the world's leading technology, Orbitrap. Earlier this year, we introduced three new mass spectrometry product platforms that will continue to drive new areas of research. At the same time, we continue to demonstrate our leadership position in vertical markets such as food safety and in more routine applications. Q Where do Asia Pacific and particularly India and China stand in the company's overall global strategy? Our intent is to develop the infrastructure to support the development and manufacturing of products for consumption in key markets such as China and India. We have opened a second demonstration center and a technology center in China in the last 12 months and we recently announced the first technology center in India. These are investments that will enable us to attract more customers in the region. We are also engaged in recruiting talented engineers and scientists from Indian universities, so that research and development work can be done locally. Could you give us a comparative perspective of Thermo Fisher Scientific's business in China and India? Our Asia Pacific revenue is 13 percent of the total revenue or approximately $1.3 billion, of which 32 percent is from China and 10 percent from India. Q Could you share with us some of the company's achievements in Asia Pacific during the last one year? Financially, we have been doing very well. If you look at the last five years, our cumulative growth has been close to 17 percent. We continue to increase our workforce here to expand local support. Last year, we added 225 commercial function manpower in Asia Pacific. We have been active on acquisitions. As I said, in India, we acquired Qualigens and Chemito. In Australia, we acquired Lomb Scientific, which is known for its lab chemicals and instruments. Nayantara Som in Mumbai ]]> <![CDATA[SIRO Clinpharm launches training center]]> https://biospectrumindia.com/news/95/2394/siro-clinpharm-launches-training-center.html https://biospectrumindia.com/news/95/2394/siro-clinpharm-launches-training-center.html Tue, 13 Sep 2011 12:23:00 +0530 SIRO Clinpharm announced its plans to launch the Center of Excellence for Medical Writing (CEMW), a first of its kind training institute in the field of medical writing in India. The center will offer a basic certificate and an advanced course in medical writing for duration of three months each. Emphasizing on quality training, the number of seats will initially be restricted to only 30. Eligible candidates should have at least a degree in the medical profession (MBBS, BAMS or BHMS). Postgraduates in pharmacy and life sciences may also apply. â€œWe are excited about launching this one of a kind institution in India. The faculty of CEMW will include the best trained and qualified industry experts in medical writing from SIRO's SBU, SCEDAM (The Strategic Center of Excellence for Data, Analysis and Medical Writing),â€? said Nimita Limaye, PhD, VP and global head â€“ SCEDAM and CEMW. â€œIndia is a key destination for outsourcing of medical writing, owing to its large scientific and medical community and the command over the English language. There is a paucity of professionally managed quality training solutions in the industry. Also, since medical writing is a niche domain, there is a huge demand-supply gap of trained medical writers. The CEMW will not only fill the need for a high quality training institution but will also act as a springboard for candidates aspiring to join the medical writing industry,â€? said Mr Ajit Nair, president, Asia operations at Siro Clinpharm. 'Govt should speed up approval process' In light of the current controversies surrounding clinical trials and increasing competition from China and Latin American countries, the clinical research industry in India has called for various measures to maintain India's image as an attractive destination for conducting clinical trials. Speaking to BioSpectrum, Dr KH Ramanjaneya, managing director, SMO Clinical Research (SMO-India), a privately owned site management organization offering comprehensive services from Bangalore, asked for better training at the site level and stringent checks on smaller unregulated companies carrying out trials. â€œOnce the basic set-up of the clinical trials adheres to strict guidelines not only will it improve the overall environment of conducting such trials, but also encourage investment from foreign companies,â€? he said. â€œCurrently, India has various appealing features such as a large ethnically and culturally diversified pool of an English speaking population. We should take advantage of this situation,â€? he said. Lamenting the slow rate of approvals from the regulatory agencies, he added, â€œThe general perception is that approvals come very slowly in India and is one of the reasons why foreign companies are hesitating to invest here. The government should take the necessary measures to address this issue.â€? Phase IIb trials begin for Revamilast Glenmark Pharmaceuticals has initiated phase IIb human dose range finding trials globally for its novel chemical entity Revamilast (GRC 4039). Revamilast is an orally active, potent and selective inhibitor of phosphodiesterase 4 (PDE 4) that is currently being developed by Glenmark for the treatment of chronic inflammatory disorders such as asthma, rheumatoid arthritis and other inflammatory diseases. The phase IIb studies will help establish the efficacy and safety of the molecule and will also provide dose range finding data for Revamilast. â€œThe clinical trials and the animal studies data for Revamilast are promising for both asthma and rheumatoid arthritis. There is a huge unmet need for both these chronic medical conditions globally. For Glenmark, this is a significant development as we have built on more than a decade of experience in the PDE 4 space to progress an exciting molecule to phase II human trials,â€? said Dr Steffen Stuerzebecher, president and chief medical officer, Glenmark Pharmaceuticals. Glenmark has already received approval from respective authorities in the UK, Poland, India and Czech Republic to conduct phase IIb studies. Regulatory submissions have also been completed in Russia. Glenmark has also initiated another global phase IIb trial with Revamilast in patients with rheumatoid arthritis. It has already received approval from the MHRA, UK, India, Poland and the Philippines to conduct the phase IIb studies. Regulatory submissions have also been completed in Sri Lanka. ]]> <![CDATA[Ipca acquires Onyx Research Chemicals]]> https://biospectrumindia.com/news/95/2362/ipca-acquires-onyx-research-chemicals.html https://biospectrumindia.com/news/95/2362/ipca-acquires-onyx-research-chemicals.html Tue, 13 Sep 2011 12:21:00 +0530 Ipca Laboratories has acquired 100 percent share capital of Onyx Research Chemicals, which is a holding company of Onyx Scientific, through its wholly-owned subsidiary in the UK, namely Ipca Laboratories UK. The acquisition will bring together two contract manufacturing organizations (CMOs) on a global basis, says a statement released by the company. Onyx Scientific is a chemistry solution provider and, post acquisition, it will continue to operate out of its facility in Sunderland, UK, under the Onyx Scientific tradename. Onyx Scientific's expertise in chemistry services for medicinal, pre-clinical and phase I/II programs will dovetail effectively with Ipca's capabilities in supporting phase II to commercially scale programs. Ipca laboratories, based out of Mumbai, is well-established domestically and has strong thrust on exports. It exports to over 110 countries and that accounted for 55 percent of its turnover. Piramal acquires 5.5% stake in Vodafone Piramal Healthcare agreed to purchase approximately 5.5 percent of the issued equity share capital of Vodafone Essar from ETHL Communications Holdings (Essar) for cash consideration of approximately 2,856 crore ($640 million). The transaction follows the settlement between Vodafone and Essar over the sale of Essar's approximately 33 percent stake in VEL, announced on July 1, 2011. The transaction contemplates various exit mechanisms for Piramal, including both participation in potential, initial public offering of VEL and sale of its stake to Vodafone. Piramal Healthcare had consolidated revenues of 2,074 crore ($454 million) in FY2011. With assets across North America, Europe and Asia, it has significant presence in the global critical space with sales of anesthesia products to over 100 countries. Recently, Piramal also entered into the financial services sector. Lupin, Medicis sign R&D agreement Lupin has entered into a research and development agreement with Medicis Pharmaceutical to apply proprietary Lupin formulation technologies to multiple therapeutic compounds. Under the terms of the agreement, Lupin will receive a 91.3 crore ($20 million) upfront payment from Medicis and will primarily be responsible for formulating certain novel therapeutic products for Medicis, utilizing several of Lupin's formulation technologies. Medicis will have global exclusive rights (excluding India) for the products developed under the agreement. Lupin will be eligible for future research and development, regulatory and other milestones of up to 173.5 crore ($38 million), as well as a single digit royalty on sales by Medicis. On the other hand, Medicis will be responsible for further development and commercialization of the licensed products. Dr Reddy's acquires JB Chemicals India's leading pharmaceutical company, Dr Reddy's Laboratories, has entered into an agreement with JB Chemicals & Pharmaceuticals to acquire their pharmaceutical prescription portfolio in Russia and other CIS regions. The agreement involves acquisition of 20 brands, the key ones being Metrogyl and Jocet, for a consideration of 158.8 crore ($34.85 million). Dr Reddy's also entered into a supply agreement with JB Chemicals for continued manufacturing and supply of these products associated with the acquired brands. â€œThis acquisition will help expand our prescription, hospital and OTC portfolio, complement our existing strong basket of products and add to our growth aspirations in the Russia and other CIS region,â€? said Satish Reddy, MD and COO, Dr Reddy's. Wockhardt to divest business Pharmaceutical and Biotechnology major Wockhardt and its subsidiary is divesting its nutritional business to French-based food company Danone. Wockhardt has presence in India's nutritional category with Farex, Dexolac, Nusobee and Protinex. Danone will acquire Wockhardt's nutrition business and brands as well as its related industrial operations from Carol Info Service (located in Punjab, India) for a total of approximately $362 million (â‚¬250 million). The strong brand awareness of Wockhardt's Dexolac, Farex and Nusobee baby nutrition products will accelerate Danone's entry into the country's baby nutrition market. The acquisition will provide Danone access to a distribution network with nationwide reach. ]]> <![CDATA[Industry interaction takes centerstage at lecture]]> https://biospectrumindia.com/news/95/3316/industry-interaction-takes-centerstage-at-lecture.html https://biospectrumindia.com/news/95/3316/industry-interaction-takes-centerstage-at-lecture.html Tue, 13 Sep 2011 12:19:00 +0530 BioSpectrum kicked-off its Student Lecture Series 2011 with an event at The Oxford College of Science in Bangalore. An account of industry leaders addressing the students about career options in biotechnology Students listen to the speakers at The Oxford College of Science's auditoriumStudents listen to the speakers at The Oxford College of Science's auditorium In an effort to bridge the gap between the student community and the biotechnology industry, BioSpectrum recently organized the first of its student lecture series in association with The Oxford College of Science, Bangalore. The event was the first of a series of lectures to be held in colleges across India. Titled 'Getting started on the career ladder', the event brought together biotechnology industry leaders, academicians and students. Over 600 students of biotechnology from different colleges of Bangalore participated in the event. The speakers were from different fields such as government agency, industry association, clinical research organisation and biopharma companies. Mr Narayanan Suresh, group editor of BioSpectrum, kicked-off the event by announcing the results of the 7th BioSpectrum Top 20 Biotechnology School Survey 2011. After lighting the ceremonial lamp and releasing the August issue of BioSpectrum that features the Top 20 BT School Survey 2011, Mr B M Vijay Shankar, additional managing director of Karnataka Biotechnology and Information Technology Services (KBITS) and chief guest for the event, spoke about using science as a tool for solving problems through different innovations. He said that the world was standing on the threshold of change and biotechnology was driving this global transformation. Talking to the students about the various initiatives taken by the Karnataka government to aid the student community, he said that the Karnataka government was setting up 12 finishing schools across the state to allow students gain hands-on experience. â€œThese finishing schools will be beneficial for the students as well as the industry,â€? he said. He also spoke on the various hubs coming up in Bangalore that will act as centers of learning for the students. Mr Narsimha Raju, executive director of The Oxford Group of Educational Institutions, urged students to make use of the opportunities and interact directly with the people from the industry, which would help them understand the different roles to be played in the industry. During the interaction sessions, the speakers answered questions asked by students and advised them on their career path. Some of the students were awarded free subscriptions of BioSpectrum through a lucky draw. The event was concluded by Mr Narayanan Suresh, who spoke on the need for such interactions between the academia and the industry in order to reduce the disparity.Through the kaleidoscope var imgarray= new Array(); var loadarray= new Array(); imgarray[0]="http://biospectrumindia.ciol.com/images/content/2011/sep/DSC_0035-lamp-lightning.jpg"; imgarray[1]="http://biospectrumindia.ciol.com/images/content/2011/sep/DSC_0111-Felicitation-of-Vi.jpg"; imgarray[2]="http://biospectrumindia.ciol.com/images/content/2011/sep/DSC_0056.jpg"; imgarray[3]="http://biospectrumindia.ciol.com/images/content/2011/sep/DSC_0355.jpg"; imgarray[4]="http://biospectrumindia.ciol.com/images/content/2011/sep/DSC_0085.jpg"; imgarray[5]="http://biospectrumindia.ciol.com/images/content/2011/sep/DSC_0262.jpg"; imgarray[6]="http://biospectrumindia.ciol.com/images/content/2011/sep/DSC_0048.jpg"; imgarray[7]="http://biospectrumindia.ciol.com/images/content/2011/sep/DSC_0058.jpg"; imgarray[8]="http://biospectrumindia.ciol.com/images/content/2011/sep/DSC_0300-Satya-dash-interra.jpg"; Prev Next var slide; document.onload=setting(); function setting() { slide=document.getElementById('pic'); slide.src=imgarray[0]; } /*create image space in mem*/ for (var j=0; j ]]> <![CDATA[India, EU resolve dispute on generic drugs]]> https://biospectrumindia.com/news/95/1904/india-eu-resolve-dispute-on-generic-drugs.html https://biospectrumindia.com/news/95/1904/india-eu-resolve-dispute-on-generic-drugs.html Tue, 13 Sep 2011 12:17:00 +0530 The dispute triggered by the repeated instances of seizure of Indian generic drugs that are destined for export to Latin American and other countries at European Union (EU) ports, has been resolved. According to a statement by Ministry of Commerce on July 28, 2011, India initiated dispute settlement consultations on May 11, 2010, at the World Trade Organization with the EU on the issue of detention of Indian generic medicines while in transit through the EU. The custom authorities at EU ports had made detentions of the generic medicine consignments under the ECs Regulation 1383/2003, which contains customs procedures for taking action against goods suspected of infringing intellectual property rights. These detentions were in violation of the obligations of the EU and the Netherlands under Article V of GATT that enshrines freedom of transit of goods through the territory of each contracting party of GATT via the routes most convenient for international transit, said the statement, adding that they were also inconsistent with the EU and its member states obligations under Articles 41 and 42 of the TRIPS Agreement. Brazil also filed a similar complaint against the EU before the Dispute Settlement Body of the WTO. India and Brazil jointly held two rounds of consultations with the EU in Geneva and EU acknowledged that some provisions of the EC Regulation 1383 were misinterpreted while detaining the Indian generic drugs. Thereafter, India engaged in extensive consultations with the EU with the assistance of legal experts. India and EU reached an understanding which, inter-alia, contains the principles to guide border enforcement of intellectual property in the EU. Approval to market Nyloxin in India Nutra Pharma, a biotechnology company developing treatments for multiple sclerosis (MS), human immunodeficiency virus (HIV), adrenomyeloneuropathy (AMN) and pain, has received approval in India for its Nyloxin line of pain relievers. Following the approval, Nutra Pharma accepted orders for the products through their distributor, Nutritional Alliance, for export to India-based importers. â€œThe India approval is our first regulatory authorization overseas and represents one of the more significant international market opportunities for Nyloxin,â€? said Mr Rik J Deitsch, chairman and CEO of Nutra Pharma Corporation. â€œWith the population of India exceeding a billion people and with limited patient access to opioid-based pain relievers throughout the country, India represents a potentially significant customer base for Nyloxin.â€? â€œWe were honored that Nutra Pharma partnered with us on their distribution and growth of Nyloxin,â€? said Mr Jim Airaghi, founder and president of Nutritional Alliance. â€œWe have already been working diligently with domestic and international distributors. The registration in India represents the first step in our global marketing plan that we believe will make Nyloxin one of the most exciting healthcare products of 2011.â€? Nyloxin is an over-the-counter pain reliever clinically proven to treat moderate to severe (stage II) chronic pain. US FDA approval for Acarbose tablets Strides Arcolab has received US FDA approval for Acarbose tablets (25 mg, 50 mg and 100 mg). Acarbose is a niche anti-diabetic drug used to treat type 2 diabetes mellitus. According to March 2011 IMS data, the total US market for Acarbose tablets approximated to $21 million with no Indian generic players in the market. The pharma division has a total of 37 filings with the US FDA (21 under the PEPFAR program and 16 as generics). So far, 22 approvals (17 under PEPFAR and five generics) have been given. This product will be marketed and sold by Perrigo under a profit sharing partnership. It is expected to be launched in Q3 2011. Industry call to expedite BRAI bill To request policy makers to expedite the process of turning the Biotechnology Regulatory Authority of India (BRAI) Bill into law, farmers, scientists and industry experts came together in support of the bill at an event in New Delhi. The event was organized by the Association of Biotechnology Led Enterprises (ABLE). The participants sought the establishment of a single-window regulatory authority in biotechnology. While stressing that the time was ripe for the government to act and streamline the regulatory process in India, the group demanded that Parliament clear the BRAI and Seeds Bill. They agreed that use of new technologies in agriculture was the only hope for farmers and a solution to address the challenges of food security. The group emphasized on expeditious approvals of biotech crop trials and commercialization under the existing system until the BRAI Bill was approved. ]]> <![CDATA[Syngene enters drug discovery pact]]> https://biospectrumindia.com/news/95/1516/syngene-enters-drug-discovery-pact.html https://biospectrumindia.com/news/95/1516/syngene-enters-drug-discovery-pact.html Tue, 13 Sep 2011 12:15:00 +0530 Biocon subsidiary, Syngene International, entered into an agreement with US-based, Endo Pharmaceuticals, to expand their collaboration to develop molecules to fight cancer. â€œSyngene and Endo will partner on two new discovery programmes, strengthening their ongoing alliance in cancer research,â€? stated Syngene in a filing to the Bombay Stock Exchange (BSE). Syngene and Endo had inked a pact for drug discovery collaboration in March 2010. As per that agreement, Endo would retain all rights to the molecules developed, while Syngene would receive research fees, milestone payments and success fees from Endo. â€œThis expansion reflects both the progress being made by Endo in the exciting area of novel therapeutic interventions to treat cancer, and Endo's confidence in Syngene's discovery and development capabilities in strengthening Endo's pipeline,â€? said Mr Peter Bains, director of Syngene. Both the firms would leverage their complementary and synergistic capabilities towards innovating novel therapeutic molecules for a robust cancer pipeline, the company said. Jubilant net profit up 53 percent in Q1 The consolidated net profit of Jubilant Life Sciences rose by around 53 percent to 77.12 crore ($16.8 million) for the first quarter ending June 30, 2011, over 50.43 crore ($10.9 million) registered in the same period in the previous fiscal. The Q1 results announced by the company on August 9, 2011, showed the increase in the net sales of the company to 944.29 crore ($205 million) as compared to 817.62 crore ($177.9 million) during the same period in previous financial year. Expressing their optimism on continued growth, Mr Shyam S Bhartia, chairman and managing director, and Hari S Bhartia, co-chairman and managing director, Jubilant Life Sciences, said Jubilant expected to continue the growth momentum with the commissioning of new capacities; innovation led product launches, expansion in high growth geographies and increased capacity utilization in services business. R Sankaraiah, executive director (finance) Jubilant Life Sciences, said the company was focusing on discovery of new molecules and success has been achieved with the number of molecules in the drug discovery increasing from 17 to 21. â€œThere are 1,000 scientists working in the NDDS and there is an equal opportunity for expansion in this area too,â€? he said. During the quarter, the company filed one DMF in the US taking the total US DMF filings to 52, besides filing two DMFs in Canada and one unique EDMFs in EU along with few in other markets including Australia. The API plant at Nanjangud, India, received the ANVISA Brazil approval during the quarter. There were three ANDA filings in the US. It received one ANDA approval for donepezil to be supplied from its solid dosage formulation plant in Roorkee, India, and one dossier approval for sildenafil, with patent expiry expected in June 2013. The Roorkee plant which already has USFDA and UKMHRA approvals, also received Japanese PMDA certification during the quarter. Venus gets US patent for Vancoplus Chandigarh-based Venus Remedies, a leading research-based global pharmaceutical company, received its first US patent for its novel research product, Vancoplus. The patent grant is valid up to December 2027. Vancoplus, a brand of ceftriaxone and vancomycin along with a chemical vector, used in CVMC technology, is the only remedy after vaccination to treat MRSA and multi-drug resistant microbes that cause meningitis, pneumonia, typhoid, septicemia, urinary tract infection, skin and skin infections and staphylococcal endocarditis. The estimated medical cost due to MRSA in USA was $5 billion in 2010 and is expected to reach $9 billion in the next five years. With Vancoplus,Venus expects to grab a fair share of this market within three years of its launch. Wockhardt reports 193.9 cr net profit Pharmaceutical and biotechnology major, Wockhardt, announced its first quarter results (April â€“ June 2011) for FY 2011-12. Consolidated sales revenue was 1,053.2 crore ($229.1 million), which is a growth of 14.3 percent. Operating profit (EBIDTA) was 310.8 crore ($67.6 million), a growth of 72.5 per cent and net profit was 193.9 crore. â€œWockhardt is focused on its fundamental priority of delivering a sustained all-round performance this year and in turn create value for all its stakeholders,â€? said Dr Habil Khorakiwala, chairman, Wockhardt. â€œOur positive first quarter results of FY 2011-12 is a pointer in this direction.â€? During the quarter, Wockhardt's India business grew by over 24 percent with a market share of 2.03 percent (IMS June 2011). GSK net sales up 13 pc in Q2 2011 GlaxoSmithKline Pharmaceuticals released its financial results for the second quarter ending June 30, 2011. During the quarter, the company clocked sales of 561.54 crore ($122 million) as against 497.93 crore ($108 million) during the second quarter last year. While the net sales grew by 13 per cent, sales of the core pharmaceuticals and vaccines business grew by 14 per cent. Profit after tax (before exceptionals) grew by nine per cent during the quarter, and the operating profit margin was maintained at 35 per cent in line with the first quarter of 2011. Net profit for the quarter was 147.54 crore ($32.1 million). Planned investments in field force expansion for the year continued during the quarter. â€œThe company's growth has been in line with the market growth. In particular, oncology, dermatologicals and mass specialty therapies have grown well. In addition to the base effect, vaccines have shown strong growth,â€? said Dr Hasit B Joshipura, managing director of GSK. Apart from the two original products from the GSK pipeline in oncology and haematology, a branded generic and a product in Stiefel, dermatology, was launched during the quarter. Eli Lilly India, Lupin announce tie-up Eli Lilly India and Lupin have entered into a strategic collaboration to promote and distribute Lilly's Huminsulin range of products, including Huminsulin R, Huminsulin NPH, Huminsulin 50/50, Huminsulin 30/70 and Humapen Ergo II. Lupin's India formulations business will promote and distribute the range of products in India and Nepal, virtually doubling the number of sales representatives behind the diabetes care product. This collaboration will double the current customer base and approximately 45,000 doctors will now be called on as a result of the new partnership. Lilly hopes to increase access to Huminsulin products through its relationship with Lupin India, bringing one of the most basic and proven therapies for diabetes treatment to more patients. Lupin India's formulation business will deploy a sales force of medical representatives to provide education and resources to physicians and patients. â€œThis partnership will allow us to change our game in India. We will have a stronger footprint with many more sales representatives promoting our diabetes brands, and this will become a foundation to expand our diabetes business not only for current products, but also for our future pipeline. Lupin is well-aligned with Lilly's goal of expansion in India and other emerging markets,â€? said Mr Eberhard Ludewigs, vice president, emerging markets, Eli Lilly. â€œWith Lilly's presence and expansion in the emerging markets space, the leadership team at Lupin feels strongly about the collaboration and the synergy it will create,â€? said Mr Shakti Chakraborty, group president, India region formulations, Lupin. SGB, BP venture join hands for biofuel Bharat Renewable Energy, a joint-venture of Bharat Petroleum, which is India's second largest petroleum company, with SG Biofuels (SGB) will develop and deploy elite hybrids of jatropha for the production of biodiesel in India. The program's first phase includes a crop development effort to produce high performing hybrid varieties of jatropha adapted to unique growing conditions across the country. Additional phases include the deployment of more than 86,000 acres of jatropha using SGB's JMax hybrid seeds. â€œWith the genetic diversity of their jatropha hybrid material combined with the ability to produce large volumes of hybrid seed, SG Biofuels is an ideal partner to work with to successfully develop, validate and scale jatropha as the primary source for biodiesel in India,â€? said Mr MV Radhakrishnan, chief executive officer of Bharat Renewable Energy. SGB will draw from the advancements of its global JMax crop development centers, where the company is optimizing elite hybrid varieties of jatropha through a combination of molecular breeding and biotechnology. The centers feature hybrid material from the company's germplasm library totaling more than 12,000 genotypes. SGB will work with BREL to select, test and scale the highest yielding, most commercially viable hybrid varieties for growing in India, including the initial 86,000 acre deployment. According to the Asian Development Bank, the current cultivation of jatropha and other non-edible oilseeds will need to increase by nearly 80 million acres to meet the nation's biodiesel targets. Zinsser HTS system installed at Piramal Life Sciences Sangama Scientifics, a professionally managed scientific instruments distribution company from Bangalore, has installed automated system for polymorphism, pre-salt screening and solubility studies called CRISSY, at Piramal Life Sciences in Mumbai. This is the first HTS system from Zinsser Analytic, a German company, to be installed in India. Sangama's release said CRISSY is capable of precise dispensing and weighing of drug candidates and solvents. The system boasts of a specially designed reactor blocks, controlled heating and cooling with mixing, evaporation and drying, filtration, pH measurement and adjustment, preparation of HPLC, XRD, Raman sampling for the direct analysis. Polymorph screening is essential to obtain a controlled chemical and pharmaceutical manufacturing process and is an economically necessary tool in drug discovery. Viscotek GPC, Zetasizer Nano combined in research Researchers at the Department of Bioengineering, University of Pittsburgh, combined Malvern Instruments' Viscotek gel permeation chromatography (GPC) system and Zetasizer Nano for their work. Molecular weight and distribution measurements were necessary for the researchers to study the synthesis of novel polymers. They used the Viscotek GPC system to characterize molecular weight, prior to applying the Zetasizer Nano for zeta potential measurements to study inter-molecular interactions. The Viscotek line of instruments offers a complete, temperature-controlled, advanced, multidetector system that is suitable for all macromolecular applications. The Zetasizer series measures particle and molecular size from below a nanometer to several microns, zeta potential, electrophoretic mobility, and molecular weight. GE Healthcare to acquire PAA Laboratories GmbH GE Healthcare has reached an agreement to acquire PAA Laboratories, a developer and supplier of cell culture media for biomedical research and the fast-growing biopharmaceutical and vaccine manufacturing industry. The acquisition of PAA Laboratories will allow GE Healthcare to expand its offering of products and services for cell biology research and for the discovery and manufacture of biopharmaceuticals, including recombinant proteins, antibodies and vaccines. The strong strategic fit between the two businesses, combined with expanded capabilities in product development and marketing, will offer significant long-term customer benefits. Financial terms of the agreement were not disclosed. The acquisition, which is subject to customary closing conditions, including regulatory approvals, is expected to close in Q3 2011. Thermo Fisher unveils Revco UxF Series freezers Thermo Fisher Scientific has introduced its new Thermo Scientific Revco UxF Series ultra-low temperature (ULT) freezers. Equipped with a unique touch-screen control panel that features an event log, health monitoring system and controlled access options, the Revco UxF Series provides a constant update on the integrity and health of the freezer compartment. The freezers maximize sample storage capacity while minimizing footprint inside the lab. Five new capacities, ranging from 421 to 949 liters (14.9-33.5 cu ft) have been launched and will provide a number of options to suit any storage and lab space requirements. The freezer's new cabinet design and vacuum panel insulation allow storage of up to 70,000 2ml tubes or 118,300 1ml Thermo Scientific Cryobank tubes. iPod used for knee replacement surgery Apple has gone a step further in aiding orthopedic surgeons who conduct knee replacement surgeries. Dr Arun Mullaji, an orthopaedic surgeon affiliated to Mumbai's Breach Candy Hospital, recently conducted a knee replacement surgery on 75-year-old Gulab Singhvi navigating with an iPod using the DASH technology. With miraculous results, Ms Singhvi was able to walk on the same day. Dr Mullaji performed what Smith & Nephew claimed was the first commercial non-experimental orthopedic surgery in Asia, if not the entire world, with the aid of an iPod. DASH is a new technology from Smith & Nephew that aids joint replacement procedures with great accuracy and precision. According to a release from the company, clinical studies have shown that when computer technology is used for joint replacement the patient experiences less pain, loses less blood and has a lower risk of needing a blood transfusion. It is fully tested and approved by international regulatory bodies as being completely safe for the patient. The technology enables the iPod to connect through wireless to a camera that emits an infrared beam. The iPod, in turn, is attached to miniature instruments. The surgeon positions these instruments by reading the data on the iPod's high-resolution screen to cut the bone and place the new joint. The surgeon can thus determine the exact alignment of the leg and the new joint on the screen of the iPod. Padmashree offers MSc clinical research Bangalore-based Padmashree Group of Institutions started a master's course (MSc) in clinical research from this academic year. The course aims to provide students with a theoretical and practical understanding of the issues involved in the design, conduct, analysis and interpretation of clinical trials of health interventions. This two-year course offered by Padmashree Institute of Clinical Research (PICR) is affiliated to the Rajiv Gandhi University of Health Sciences (RGUHS) and recognized by the Government of Karnataka. â€œAll our training programs have been developed by the clinical research experts who have worked in the healthcare industry for many years. This course is an assortment of various modules of clinical research and biopharma subjects. The course is especially designed for graduates from health science and allied health science milieu. Our training programs are medical industry oriented to an extent of preclinical testing, good laboratory practice, and good clinical practice and also provide immense practical knowledge in real-life scenario,â€? said Dr Suresh Babu, principal, PICR. To provide industry interaction, PICR has set up a good infrastructure wet lab facility and has tied up with different agencies such as Padmashree Diagnostic Center, Kidwai Institute of Oncology, Bangalore Institute of Oncology (HCG Global), Aristogene, BiOZEEN, Bioneeds and Avesthagen. Indian Oil, DBT to set up research hub Indian Oil Corporation (IOC) has inked a memorandum of understanding with the Department of Biotechnology (DBT), Government of India, to set up a DBTâ€“IOC Center for Advanced Research on Bio-energy. The center is expected to offer breakthroughs to restore oil with vegetation founded fuels through biotechnological interventions. It is the second such center being set up by the DBT. The first one was at the Institute of Chemical Technology in Mumbai. This center, coming up at Indian Oil's R&D hub at Faridabad, will cost 53 crore ($11.5 million) and the DBT will share half of this cost. Workshop on plant genetic resources A workshop on â€œEfficient Management and Use of Plant genetic Resourcesâ€? was held on July 29 and 30, 2011, at New Delhi. The event was attended by over 70 participants representing various Indian Council for Agricultural research (ICAR) institutes and state agricultural universities, collectively known as the National Active Germplasm Sites. Dr RS Paroda, chairman, Haryana Farmers' Commission and TAAS, inaugurated the workshop and Dr S Ayyappan, secretary, DARE and DG, ICAR, presided over the inaugural session. The workshop focused on national networking on acquisition, conservation, evaluation and strengthening of database on plant genetic resources information. ]]> <![CDATA[INVIDA expands dermatology portfolio]]> https://biospectrumindia.com/news/95/4539/invida-expands-dermatology-portfolio.html https://biospectrumindia.com/news/95/4539/invida-expands-dermatology-portfolio.html Tue, 13 Sep 2011 12:13:00 +0530 Invida India plans to expand its dermatology portfolio in India with the launch of Papulex for acne management and atopiclair for atopic dermatitis. The company hopes to meet the needs of the rapidly expanding skin health sector in the region. â€œInvida hopes to address the gap felt by Indian patients who do not have access to the same treatment options as their Western counterparts by introducing innovative and affordable treatments,â€? said Mr Girdhar Balwani, managing director of Invida, India. â€œWe are leveraging our expertise in the area of skin health to benefit Indian patients through the launch of Papulex oil-free cream and Atopiclair cream. This is just the beginning and it is our endeavor to continually look at opportunities that can benefit the Indian patient.â€? Papulex is for long-term management of acne to reduce marks and prevent breakouts. All the Papulex variants, including the cleansing gel, isocorrexion and sunscreen, will be introduced over the next few months. Invida will also launch its new dermatology product, Atopiclair, which results in flare-remission providing symptomatic relief and control of atopic dermatitis. Atopiclair is clinically proven to reduce itch and the need for steroids. Atopic dermatitis affects up to 20 pecent of young children. The Atopiclair cream launch will be followed by the launch of Atopiclair lotion in October 2011. GSK launches two new drugs in India GlaxoSmithKline Pharmaceuticals launched two drugs - Revolade and Votrient - in India. Both the drugs are targeted towards specific patient categories. Revolade (eltrombopag) is approved for oral treatment of thrombocytopenia (reduced platelet count) in adults with the blood disorder chronic immune (idiopathic) thrombocytopenic purpura (ITP). It is indicated for the treatment of thrombocytopenia in patients with chronic immune (idiopathic) thrombocytopenic purpura (ITP), who have had an insufficient response to corticosteroids, immunoglobulins or splenectomy. Currently, there is no data available on the occurrence of ITP in the Indian population. In the European Union (EU), Revolade has an orphan drug designation. Orphan drug designation is given to medicines used to treat life-threatening or chronically debilitating conditions that affect no more than five in 10,000 people in the European Union. At the launch of Revolade, Dr Hasit Joshipura, vice president South Asia and managing director, India, said, Revolade was the first and the only oral platelet generator. â€œClinical trials have shown that eltrombopag is able to stimulate the production of platelets and reduce the risk of bleeding in this difficult to treat disease,â€? he said. Votrient (pazopanib hydrochloride tablets) is indicated for advanced renal cell carcinoma, the most common type of kidney cancer. Speaking about Votrient, Dr Joshipura said, Votrient approval in India was based on the results from a pivotal phase III study of patients with advanced kidney cancer who had either received no prior drug treatment, or had failed a cytokine-based treatment. Generic version of Gemzar launched India-based Dr Reddy's Laboratories launched Gemcitabine for injection (200 mg/vial and 1 g/vial), a bioequivalent generic version of Gemzar in the US market on July 25, 2011, following the approval by the US Food & Drug Administration of Dr Reddy's ANDA for Gemcitabine for injection. The Gemzar brand had US sales of approximately $634 million (2,896 crore) for the most recent 12 months ending May 31, 2011, according to IMS Health. Dr Reddy's Gemcitabine for injection are available in strengths of 200mg/vial and 1 g/vial in single-use vials. Ranbaxy launches Letrozole in Europe Ranbaxy Laboratories launched Letrozole tablets (2.5 mg) in the UK, Romania and France. Letrozole is the bio equivalent of Femara, the innovator product of Novartis, that has a market size of $58 million in UK, $95 mn in France and $5.5 million in Romania. â€œWe are pleased to introduce Letrozole at the earliest available opportunity in the UK, Romania and France with a view to broadening access to medication. The product will be offered through pharmacies, retail and wholesale stores with immediate effect and will benefit the healthcare system in these EU markets,â€? said Mr Debashis Dasgupta, regional director, Ranbaxy, Europe. Letrozole is an antineoplastics indicated for the treatment of breast cancer. Ranbaxy's subsidiary companies, Ranbaxy (UK), Terapia Ranbaxy and Ranbaxy Pharmacie Generiques, will be marketing this product in the UK, Romania and France, respectively Ranbaxy introduces Volini Duo in India Ranbaxy Global Consumer Healthcare (RGCH), the over-the-counter business division of Ranbaxy Laboratories, has launched Volini Duo, India's first approved two-in-one pain killer, a unique bi-layered Acetaminophen tablet, specially formulated to give dual pain relief. The product has been introduced across India. â€œRanbaxy remains committed to developing and offering quality, safe, efficacious and innovative solutions to consumers. The introduction of Volini Duo is a move in this direction,â€? said Mr Brijesh Kapil, vice president of RGCH. Volini Duo has been developed by scientists at Ranbaxy's state-of-the-art R&D centre in Gurgaon, using advanced matrix technology, which enables the regulated release of the medicine in the gastrointestinal tract. It is specifically effective for back and joint pains, which are primarily chronic in nature. Volini Duo tablet marks the entry of Ranbaxy in the over-the counter (OTC) oral pain reliever category. The OTC oral analgesics market in India is estimated to be 700 crore and is growing annually at a rate of 10.5 percent. Globally, acetaminophen happens to be the highest selling molecule in the OTC pain reliever category. Zebra Technologies introduces printer Zebra Technologies, a recognized global leader in bar code, kiosk, card and RFID printers as well as real-time location solutions, introduced its new QLn mobile printer family. Zebra addresses the growing mobile workforce with the QLn, which is the third generation of the QL printer and its all-time best selling direct thermal mobile line. The QLn builds on the success of over 700,000 QL printers that have been shipped to date by squarely addressing the primary request made by Zebra's customers to lower the cost of operation. The QLn does this by including the industry's first ethernet connection for mobile printers. By enabling remote status collection and better device management, the printer helps reduce service time and maximizes printer uptime, delivering a greater return-on-investment. â€œDemand for mobile printers continues to scale,â€? said Mr Tom Wimmer, director of AutoID and transaction processing practice at VDC. â€œAt the same time, total cost of ownership has become a leading purchase consideration for enterprises evaluating mobile devices. Knowledgeable users are increasingly focused on reducing productivity losses associated with hardware failure, and managing spiraling IT support costs. Leading mobile device suppliers like Zebra understand these requirements and are responding with smarter products designed to address them.â€? The QLn is also the first printer with Zebra's new power smart print technology. This new feature delivers faster processing and throughput with lower power drain, giving mobile workers better quality printing and more uptime on the job. Jubilant signs deal for new product Jubilant Life Sciences, an integrated pharmaceutical industry player and the largest custom research and manufacturing services company in India, has signed a long-term supply agreement in proprietary products business with a leading international life sciences company. The total contract is valued at over $80 million to be supplied in three years from the quarter April to June, 2012. This contract has a minimum volume 'take or pay' commitment and has an opportunity to go over $100 million. This product has a huge demand in the market which is vindicated by the release of advance payment by the customer on the signing of the contract. Zota to launch anti-cold drug Zota Healthcare, a Surat-based company engaged in the development and marketing of formulation products, is launching a new hepatoprotective anti-cold formulation for allergic rhinitis and common cold which can provide pain relief without toxicity to the liver. The product will be launched in January 2012. The product, ZOCOLD, is targeting allergic rhinitis patients for whom the conventional anti-cold drugs create hepatic toxicity. â€œUsually, common anti-cold products with their anti-inflammatory nature can affect liver function of allergic rhinitis patients and may develop jaundice following long term use. Our new formulation with racemethionine avoids such side effects. ZOCOLD is awaiting its patent right,â€? said Dr Sanjay Agrawal, medical consultant, Zota Healthcare. ]]> <![CDATA[India to have GLP-compliant labs]]> https://biospectrumindia.com/news/95/6644/india-to-have-glp-compliant-labs.html https://biospectrumindia.com/news/95/6644/india-to-have-glp-compliant-labs.html Tue, 13 Sep 2011 12:12:00 +0530 The Department of Pharmaceuticals, Ministry of Chemicals and Fertilizers, Government of India, is in the process of selecting a consultant to assess the existing facilities complying with the good laboratory practices (GLP) vis-Ã -vis requirement of pharma industry and drawing up schemes for upgrading the existing testing facilities to make them GLP compliant. Similarly, the Department of Science and Technology has put in place enabling mechanisms to encourage test facilities in both government and private sector to come up to the standards of GLP, including sensitizing programmes, training programmes for test facilities, and quality assurance personnel. While providing information in this regard in Parliament on August, 1, 2011, the Minister of State for Science and Technology and Earth Sciences, Mr Ashwani Kumar, said, â€œThe idea behind the move is to inculcate a GLP environment in the country and encourage test facilities to apply for a GLP Certification from the National GLP Compliance Monitoring Authority, Government of India.â€? India achieved full adherent status on good laboratory practices (GLP), certified by the Organization of Economic Co-operation and Development (OECD), on March 3, 2011. This has come after the government accepted the invitation of OECD Council to become full adherent to OECD Council Act related to mutual acceptance of data in assessment of chemicals and to join that part of chemicals programme related to mutual acceptance of data, with all of the rights and obligations of OECD member countries. ABLE-AG supports glyphosate products After a few anti-biotech crop groups put forth their views on harmful effects of glyphosate, the Association of Biotech Led Enterprises-Agriculture Group (ABLE-AG) has termed these claims as unsubstantiated and unscientific to mislead people and policy makers. ABLE argued that glyphosate products, first introduced in 1974, are registered in more than 130 countries and approved by regulators for weed control in over 100 crops. The ABLE-AG issued a press statement saying these groups were ideologically opposed to biotechnology and often utilized unvalidated claims to further their agenda, while ignoring the overwhelming weight of scientific evidence that underscores the safety and performance of these products. In support of its argument, ABLE-AG said the comprehensive, robust data set, establishing the safety of the product was available on glyphosate, the active ingredient in round-up herbicide. The association also sought to dispel rumors that Glyphosate was a carcinogen. The chronic toxicity and oncogenic potential of glyphosate have been evaluated by a number of regulatory agencies and by international scientific organizations, says the statement, adding that each of these groups concluded that glyphosate was not carcinogenic. â€œThis conclusion is based on long-term studies in which mice and rats were fed extremely high doses of glyphosate everyday for two years. The US EPA has placed glyphosate in category E (evidence of non-carcinogenicity for humans), the most favorable carcinogenicity category possible,â€? says the statement issued by ABLE-AG. ICMR seeks to commercialize technologies The Indian Council of Medical Research, New Delhi, is looking for companies interested in commercializing two unique technologies aimed at diagnosis and prevention of various diseases. The first patented technology that is ready for commercialization is a kit for the detection of the urinary oxalate for semi-quantitative analysis by disposable strips. The measurement of oxalate in urine and plasma is very important for the diagnosis and medical management of innumerable disease conditions such as primary and secondary hyperoxaluria, idiopathic, steatorrhoea, ileal disease, ethylene glycol poisoning, E-ferrol toxicity syndrome, among others. These disposable biostrips can be used by a person without the help of a laboratory and skilled person to differentiate a normal urine sample from a hyperoxaluria sample. The salient features are that it takes very less time and shows no loss of activity even after its storage at four degree centigrade for three months. Also, an alternative diagnostic technique based on reverse transcription (RT-PCR) to detect infective (L3) stage larvae (Wuchereria bancrofti) in vector mosquito (Culex quinquefasciatus) has been developed by Vector Control Research Center, Puducherry. This technique, which is not cumbersome, does not require live mosquito sample, and is amenable for large-scale screening of mosquito vectors, unlike the conventional technique. ]]> <![CDATA[PRIVATE PROFILES]]> https://biospectrumindia.com/news/95/1611/private-profiles.html https://biospectrumindia.com/news/95/1611/private-profiles.html Mon, 05 Sep 2011 14:32:00 +0530 1 SASTRA University, School of Chemical and Biotechnology 2 Jaypee University of Information Technology, Solan Department of Biotechnology & Bioinformatics 3 Manipal Life Sciences Center, Division of Biotechnology 4 Shoolini University of Biotechnology & Management Sciences, School of Biotechnology 5 Vellore Institute of Technology University, School of Bio Sciences and Technology 6 Jaypee Institute of Information Technology, Noida School of Biotechnology 7 Vidya Pratishthan's School of Biotechnology, School of Biotechnology 8 The Oxford College of Science, Department of Biotechnology 9 PES Institute of Technology, Department of Biotechnology 10 KIIT University, School of Biotechnology 11-13 14-16 17-19 20-22 23-25 26-28 29-31 32-34 35-37 ]]> <![CDATA[PUBLIC PROFILES]]> https://biospectrumindia.com/news/95/2947/public-profiles.html https://biospectrumindia.com/news/95/2947/public-profiles.html Mon, 05 Sep 2011 14:28:00 +0530 1 Institute of Chemical Technology (Deemed University) 2 Rajiv Gandhi Center For Biotechnology (Autonomus) 3 Jawaharlal Nehru University 4 University of Hyderabad 5 Jamia Hamdard, Hamdard University (Deemed) 6 Guru Gobind Singh Indraprastha University 7 Indian Institute of Technology, Kanpur 8 National Dairy Research Institute (Deemed University) 9 Tamil Nadu Agricultural University 10 Jamia Millia Islamia University 11-13 14-16 17-19 20-21 ]]> <![CDATA[ICT Mumbai stays on top]]> https://biospectrumindia.com/news/95/2398/ict-mumbai-stays-on-top.html https://biospectrumindia.com/news/95/2398/ict-mumbai-stays-on-top.html Mon, 05 Sep 2011 14:18:00 +0530 Institute of Chemical Technology, Mumbai, now a deemed university, keeps its No. 1 rank among the public institutions in the BioSpectrum Biotech School Survey 2011; Rajiv Gandhi Center for Biotechnology takes the second spot Guru Gobind Singh Indraprastha University slips to sixth place; IIT Kanpur comes seventh and NDRI follows at the eighth spot BioSpectrum Top 20 Biotech Schools (Public) Rank Name of the Institute City State Faculty Score Industry Interaction Score Infrastructure Score Placement Score Overall Score 1 Institute of Chemical Technology (Deemed University) Mumbai Maharashtra 79.83 42.21 36.54 20.57 100.00 2 Rajiv Gandhi Center For Biotechnology (Autonomus) Thiruvananthapuram Kerala 56.72 8.54 91.89 0 94.98 3 Jawaharlal Nehru University New Delhi Delhi 41.79 35.55 44.48 7.23 75.51 4 University of Hyderabad Hyderabad Andhra Pradesh 14.91 36.36 27.25 21.34 53.30 5 Jamia Hamdard, Hamdard University (Deemed) New Delhi Delhi 21.77 38.61 12.96 7.83 46.46 6 Guru Gobind Singh Indraprastha University New Delhi Delhi 13.69 5.56 48.04 13.86 44.54 7 Indian Institute of Technology Kanpur Uttar Pradesh 20.29 9.82 12.43 42.89 36.13 8 National Dairy Research Institute (Deemed University) Karnal Haryana 16.37 11.84 27.66 5.29 35.23 9 Tamil Nadu Agricultural University Coimbatore Tamil Nadu 25.70 3.50 10.28 42.90 34.01 10 Jamia Millia Islamia University New Delhi Delhi 11.54 0.01 11.09 75.64 32.28 11 University of Jammu Jammu Jammu & Kashmir 9.32 3.70 15.14 23.45 22.85 12 Banaras Hindu University Varanasi Uttar Pradesh 17.54 1.65 14.52 0 20.15 13 Tezpur University Sonitpur Assam 14.51 0.97 15.50 4.82 19.77 14 Kumaun University Nainital Uttarakhand 8.21 0.27 16.79 3.61 16.21 15 University of Mumbai Mumbai Maharashtra 5.43 0 8.79 27.23 15.33 16 Gujarat University Ahmedabad Gujarat 13.72 0.78 3.22 11.86 13.34 17 Guru Ghasidas Vishwavidyalaya Bilaspur Chhattisgarh 9.01 0.11 12.21 1.20 13.14 18 Shivaji University Kolhapur Maharashtra 13.18 0 3.63 7.17 11.64 19 Cochin University of Science and Technolog Kochi Kerala 5.64 0 8.62 9.04 10.83 20 Burdwan University Burdwan West Bengal 4.90 0.30 5.72 12.54 9.66 21 Saurashtra University Rajkot Gujarat 6.46 0 3.59 7.02 7.70 Ranking by Parameters ICT - Mumbai, country's No. 1 public BT School came on top in faculty and industry interaction ranking, the two heavy weight parameters Rajiv Gandhi Center of Biotechnology boosted infrastructure investing close to 23 crore between June 2009 and May 2011 on lab infrastructure, books, journals and consumables ]]> <![CDATA[BioSpectrum Top 20 Biotech Schools (Private)]]> https://biospectrumindia.com/news/95/7542/biospectrum-top-20-biotech-schools-private.html https://biospectrumindia.com/news/95/7542/biospectrum-top-20-biotech-schools-private.html Mon, 05 Sep 2011 14:15:00 +0530 Rank Name of the Institute City State Faculty Score Industry Interaction Score Infrastructure Score Placement Score Overall Score 1 SASTRA University Thanjavur Tamil Nadu 68.41 27.27 73.04 66.40 100.00 2 Jaypee University of Information Technology Solan Himachal Pradesh 54.82 34.10 68.53 29.00 86.72 3 Manipal Life Sciences Center Manipal Karnataka 68.07 14.87 59.91 15.00 75.66 4 Shoolini University of Biotechnology and Management Sciences Solan Himachal Pradesh 49.57 74.75 19.01 10.59 75.64 5 Vellore Institute of Technology Vellore Tamil Nadu 49.56 4.62 46.52 64.77 66.23 6 Jaypee Institute of Information Technology, Noida Noida Uttar Pradesh 43.91 2.76 32.38 27.02 45.58 7 Vidya Pratishthan’s School of Biotechnology Baramati Maharashtra 11.36 57.90 13.85 7.67 44.79 8 The Oxford College of Science Bangalore Karnataka 25.06 4.67 31.21 19.60 35.19 9 PES Institute of Technology Bangalore Karnataka 14.47 0.17 49.20 9.54 34.97 10 KIIT University Bhubaneshwar Orissa 11.71 21.35 20.90 13.52 30.72 11 KS Rangasamy College of Technology Trichengode Tamil Nadu 33.15 10.87 6.73 22.15 30.09 12 Rashtreeya Vidyalaya College of Engineering Bangalore Karnataka 26.97 7.89 8.90 29.80 28.26 13 Bannari Amman Institute of Technology Sathyamangalam Tamil Nadu 20.4 15.89 7.20 6.83 23.52 14 Jaipur National University Jaipur Rajasthan 21.36 3.78 14.52 11.72 22.50 15 Padmashree Group of Institutions Bangalore Karnataka 14.29 19.34 8.39 4.16 22.40 16 Shree Manibhai Virani & Smt Navalben Virani Science College Rajkot Gujarat 16.09 5.53 12.66 20.97 21.81 17 Dr D Y Patil Biotechnology and BioInformatics Institute Tathawade Maharashtra 14.34 0 13.72 13.25 16.99 18 Kristu Jayanti College Bangalore Karnataka 19.27 0 6.98 5.56 14.26 19 TERI University (Deemed University) New Delhi Delhi 10.95 2.66 11.95 3.85 13.82 20 Oxbridge College of Science and Commerce Bangalore Karnataka 14.39 0 8.03 12.13 13.79 21 S K Patel College of Pharmaceutical Education and Research Kherva Gujarat 11.80 1.53 10.82 7.06 13.73 22 Arunai Engineering College Tiruvannamalai Tamil Nadu 12.98 1.24 10.18 6.61 13.72 23 Banasthali University (Deemed University) Banasthali Rajasthan 22.15 1.04 3.88 0.43 13.51 24 Indian Academy Degree College Bangalore Karnataka 11.03 0.07 12.60 5.36 13.16 25 T John College Bangalore Karnataka 6.33 0 18.56 0 12.83 26 Meerut Institute of Engineering and Technology Meerut Uttar Pradesh 14.04 0.12 6.01 10.85 12.37 27 Presidency College Bangalore Karnataka 7.86 0.29 5.09 25.73 12.06 28 Gokaraju Rangaraju Institute of Engineering and Technology Hyderabad Andhra Pradesh 10.02 3.78 5.80 9.89 12.00 29 Maharani Lakshmi Ammanni College For Women Bangalore Karnataka 14.27 0.20 5.26 3.47 10.57 30 REVA Institute of Science and Management Bangalore Karnataka 8.49 0 4.29 11.41 8.80 31 Vydehi Institute of Biotech Sciences Bangalore Karnataka 8.55 0 8.40 0 8.59 32 Sri Dharmasthal Manjunatheshwara College (Autonomous) Ujire Karnataka 8.58 0 8.25 0 8.53 33 Chandigarh College of Technology Mohali Punjab 5.06 0 6.62 5.40 7.08 34 Loyal College (Autonomous) Chennai Tamil Nadu 7.10 0 5.41 2.77 6.89 35 Dayananda Sagar Institutions Bangalore Karnataka 6.29 2.17 3.47 3.78 6.83 36 MITCON Institute of Management Pune Maharashtra 5.39 0 2.80 9.42 6.08 37 Hindusthan College of Arts and Science Coimbatore Tamil Nadu 7.75 0.03 0.70 9.00 6.06 ]]> <![CDATA[Indian biotech education market garners INR 1,150 crore]]> https://biospectrumindia.com/news/95/2430/indian-biotech-education-market-garners-inr-1150-crore.html https://biospectrumindia.com/news/95/2430/indian-biotech-education-market-garners-inr-1150-crore.html Mon, 05 Sep 2011 14:10:00 +0530 According to the seventh BioSpectrum Top 20 BT Schools Survey, over one lakh students are studying in more than 500 institutions The Biotech Education Market in India has witnessed a growth of 9.45 percent in 2010-11 to touch 1,150 crore as against last year's market size of 1,050.72 crore with over one lakh students studying in more than 500 institutes. The education market mainly comprises fees collected from students. According to BioSpectrum estimates, about 50 engineering colleges and 320 private institutions are offering undergraduate, postgraduate, MPhil and PhD courses and 130 public institutions are offering postgraduate and PhD courses. The private institutions are collecting an average fee of 3.5 lakh per course per student - including government quota and management seats - excluding one time donation or capitation amount. Few institutions are charging higher fees, in some cases over three times the average. At a public institution, a student pursuing a masters degree pays an average of 52,720 for the two-year course as against last year's average fees of 49,200. Drop in demand likely Over 17 percent growth of the biotechnology industry in the last three years generated a lot of interest among educational institutions and students setting off a trend among educational institutions to offer undergraduate, postgraduate, engineering courses and PhD degree courses in biotechnology and its specialized areas. In 2010-11, many public and private institutions have increased their fees for biotech courses by 5,000 per course and 50,000-1,00,000 per course, respectively. This helped the market to witness a growth of over nine percent this year but the increase in biotech schools has now created an excess capacity in the market. The market may see a drop in the coming years with students realizing that the market demand for biotech students is not as big as they think and that they need to pursue higher studies to get placements in the industry. According to the seventh BioSpectrum Top 20 BT Schools Survey, students studying biotechnology at private institutions pay six-and-a-half times more than those at public institutions. In all, 58 institutes (21 public and 37 private) offering BTech, MSc, MTech, MPhil and PhD courses in biotechnology from 17 states participated in the 2011 survey. They enrolled 5,068 students for biotech courses in 2010-11 and have 1,153 full-time faculty members. Premier universities such as Jawaharlal Nehru University (JNU) charge a meager fee of 1,391 for a course of two years. Cochin University of Science and Technology and Banaras Hindu University (BHU) are charging 6,190 and 8,858, respectively, for entire courses. Some other public universities such as University of Hyderabad, University of Jammu, Tezpur University and National Dairy Research Institute are offering two-year postgraduate courses for 28,002, 22,630, 23,788 and 20,350, respectively. In the private sector, Shree Manibhai Virani & Smt Navalben Virani Science College is charging 25,000 per annum this year as against last year's 21,000 per annum. Maharani Lakshmi Ammanni College For Women, Bangalore, is offering biotechnology courses at 36,000 per annum against its fees of 28,000 per annum the previous year. Gokaraju Rangaraju Institute of Engineering and Technology and Loyala College, Chennai, are charging 35,000 per annum and 39,000 per annum, respectively. Other institutions in the sector are offering courses in the range between 70,000 and 1,50,000 per annum. Institutions not part of survey Some prominent universities and public institutions such as M S Baroda University (Vadodara), University of Pune (Pune), Anna University (Chennai), Madurai Kamaraj University (Madurai), University of Kashmir (Srinagar) and Himachal Pradesh University (Shimla) did not participate in this year's survey due to the ongoing admission processes and other activities. Similarly, some private institutions such as Acharya Institute of Technology, Acharya's Bangalore B-School and Sitadevi Ratanchand Nahar Adarsh College, all from Bangalore, Dolphin Institute of Biomedical and Natural Sciences, Dehradun, too did not participate in this year's survey for the same reasons. The biotechnology departments at these institutions have published 973 papers in national journals (701 by private and 272 by public institutions) and 2,625 in international journals (1,214 by private and 1,411 by public institutions) between 2007 and 2011. They received 47 patents in India and 29 patents from international agencies during the same period. These institutions also received projects totaling to 264.85 crore during 2007-11. As much as 24 crore of this is from the industry, while the rest is from government agencies. The Institute of Chemical Technology (ICT) has projects worth 88.28 crore, Indian Institute of Technology, Kanpur (IIT-K), has 25.59 crore-projects, Rajiv Gandhi Center for Biotechnology has 23.05 crore-projects, SASTRA University has 28.86 crore-projects, JNU has 15.7 crore-projects and Manipal Life Sciences Center received projects worth 10.35 crore. All these institutions also increased their spending on books, journals, infrastructure and lab consumables during 2009-11 to 142 crore from 84.72 crore spent during 2007-09. Some of the institutes that spent over 10 crore under these heads during the last two years include Rajiv Gandhi Center for Biotechnology, the Institute of Chemical Technology, Jaypee University of Information Technology, Solan, and SASTRA during 2009-11. In 2010, 3,693 students from these institutions cleared examinations and 1,187 of them opted for higher studies. Of the 1613 students who were placed during campus recruitment, 987 were BTech degree holders, 599 were MSc/MTech and the rest had MPhil and PhD. The highest cost to company (CTC) offered at RV College of Engineering, Bangalore, was 10.5 lakh per annum, while highest CTC offers received at IIT-K, Vellore Institute of Technology University and SASTRA were 10 lakh, 9.7 lakh and 7.2 lakh per annum, respectively. Highest CTC offers for postgraduate students from Vellore Institute of Technology University, IIT-K, and ICT were 11.8 lakh, 5.25 lakh and 5 lakh per annum, respectively. JNU remained the most sought after university with 2,500 applications received for eight PhD seats. The University of Hyderabad and IIIT-K received 1,165 applications for eight seats and 498 applications for 11 seats, respectively. For postgraduate courses, the University of Hyderabad received 2,250 applications for 41 seats, JNU received over 10,000 applications for 29 seats, Banasthali University, Rajasthan, received 1,412 applications for 140 seats, KIIT University received 1,837 applications for 60 seats, Jamia Millia Islamia received 1,760 applications for 34 seats, Jamia Hamdard received 2,347 for 42 seats and Vellore Institute of Technology University received 3,680 applications for 406 seats for 2010-11 academic year. ]]> <![CDATA[New chromatography CoE in Ahmedabad]]> https://biospectrumindia.com/news/95/2038/new-chromatography-coe-in-ahmedabad.html https://biospectrumindia.com/news/95/2038/new-chromatography-coe-in-ahmedabad.html Mon, 05 Sep 2011 12:58:00 +0530 Thermo Fisher Scientific inaugurated its new centre of excellence (CoE) for Chromatography Consumables and Specialty Products in Ahmedabad, Gujarat, to provide  enhanced application support for customers working across a broad range of applications, including pharmaceutical, environmental and food and beverage for the Asia Pacific region. The facility, located in the city’s Pharma SEZ and spanning across an area of 3,500 square feet, is adjacent to the existing Fisher Biopharma services facility with an employee strength of around 70 people. This is the first centre of excellence for the company in the APAC region.  “Our investment in APAC region brings us in closer proximity to our customers and offers a local resource for technical and product support as we continue to build on our growth in the region,” said Syed Jafry, senior vice president and president, Thermo Fisher Scientific for Asia Pacific and South America. Above all, in India, the company chose to open the CoE in Ahmedabad due to its strategic proximity to most of the top level pharma companies in the country and conducive environment for investment into the state. The Pharma SEZ, for instance, houses facility set-ups of companies like Zydus Cadila, Piramal Healthcare and Intas Pharmaceuticals. Life Tech opens India distribution center Life Technologies, a global biotechnology company dedicated to improving human condition, has opened its regional distribution hub in India to address strong customer demand in the South Asia region. The new India distribution center, located in Bangalore, will boost the availability, timely delivery and quality of Life Technologies’ products to its thousands of customers in the area. Life Technologies operates as Invitrogen Bioservices India in India and commenced operations in the year 2005 from Bangalore. The India distribution center, which spans a built-up area of 25,000 square feet, adopts a hub-and-spoke model, with Bangalore as the regional hub for Life Technologies’ product distribution throughout India. Since the center’s inception, the company’s volume of items shipped per day in the region has increased four-fold with dramatically improved order fulfillment time that is up to 50 percent faster in most cases.  Persistent invests with Life Technologies Persistent Systems is partnering and co-investing with Life Technologies, a global biotechnology tools company, to build sequencing and fragment analysis software platform for capillary electrophoresis instrumentation that will be submitted for FDA clearance/approval. This solution represents an advanced genomic technology for clinics taking a step towards making personalized medicine a reality to combat critical human diseases like cancer. They will work together to develop an integrated interpretation software and hardware solution that will intelligently use sequencing technology to analyze patient DNA samples through advanced, user-friendly software. As a technology partner, Persistent Systems will also be providing services to integrate assays from third party vendors. Cole-Parmer’s new catalog launched Cole-Parmer is launching its fifth annual catalog for scientific and process industry for the Indian market. The 272-page catalog has numerous unique and new products, as well as returning favorites. It is segmented into four key sections, i.e. ―fluid handling, laboratory essentials, process equipment, and laboratory equipment. This 2011 catalog is similar to last year’s catalog, yet also offers enhancements. It has new products and competitive prices, and is designed to help customers in their product scale-up. The catalog also has dual pricing featuring custom duty exempt prices and prices in rupees, making it handy for users to set up supply contracts. Malvern Zetasizer Nano in research Prof Steven Armes and his research team in the Department of Chemistry, at The University of Sheffield in the UK, are using a Zetasizer Nano instrument from Malvern Instruments to monitor the rapid and efficient production of nanolatexes. This single instrument can determine both the particle size distribution and also monitor the zeta potential, making it an ideal characterization tool for following the in situ synthesis of many types of polymer colloids, such as latexes, microgels or colloidal nanocomposite particles. “The Zetasizer Nano is so easy to use,” said Prof Armes. “All my students can familiarise themselves with it very quickly. We are purchasing a second instrument. ]]> <![CDATA[Work Environment: The Positive Effect]]> https://biospectrumindia.com/news/95/1808/work-environment-the-positive-effect.html https://biospectrumindia.com/news/95/1808/work-environment-the-positive-effect.html Mon, 05 Sep 2011 12:57:00 +0530 When it comes to offering a comfortable work zone and the best incentives, biotech companies are no less than the IT and manufacturing firms. In fact, their HR teams are putting the best efforts to provide world class facilities and are even going the extra mile to make the employees feel at ease and stay productive Work environment has emerged as a critical employee policy, with the growth of the industry. This has marked a sea change and is now well recognized to be one of the critical parameters of employee retention. Therefore, providing the best work environment and empowerment of employees remain the top priority of all biotech companies. Besides concentrating on providing the basic facilities, the companies with, each passing year, are adding new initiatives in order to keep the employees motivated. Comfort zone Performance of the employees is directly linked to their work environment. Therefore, the companies have been giving special attention on creating centralized AC facilities at their office locations. Apart from regular facilities such as library and subsidized canteen, companies are also making periodic celebrations a part of the work life. Also, the focus in many companies is to improve the IT infrastructure as it is directly associated with the employee performance. Most of the top ranking biotech companies have formulated unique policies to make the employees comfortable. New Delhi-based Panacea Biotec, one of the leading vaccine players in India, believes that providing infrastructure facilities at work place is essential for employees to give their best. The company offers one of the best cafeteria facilities with well-equipped gymnasium and expansive green landscapes. Mr Kulvinder Sarao, vice president, HR, Panacea Biotec, says “We believe in the personal touch and this is what defines our company’s welfare policies, which is derived from our core value of being humane.” Putting efforts to create a conducive campus environment, Reliance Life Sciences (RLS), which is based at Mumbai, has made a lot of improvements in terms of the architecture, landscaping, biological diversity and availability of various facilities that cater to the requirements, such as banking transactions, health and wellness and food and refreshments. The company has also brought in the fun element within the ambit of its day-to-day functioning. Mr KV Subramaniam, president, Reliance Life Sciences, says, “RLS lays significant emphasis on creating a work environment conducive to productivity at campus. Besides providing an in-house cafeteria, there is a gymnasium, a 24 hour tea and coffee vending facility, auditorium and round-the-clock in-house security.” In addition to providing a similar work environment, Novozymes, one of the leading enzymes companies in the world, provides special attention to the employees by sponsoring their vacations up to a certain limit. Says Mr G S Krishnan, regional president, Novozymes, “For us, the work and life balance is important and we, therefore, give them all the facilities they deserve. We sponsor everything from free snacks to picnics and try to make them comfortable.” A similar kind of work environment is provided to the employees by diagnostic companies as well. Mumbai-based Transasia Bio-Medicals, a leading diagnostics company, keeps recreation and work life equally balanced. Says Mr G Jayaraman, head — HR, administration and CSR, Transasia Bio-Medicals,“Providing conducive environment at work tops our priority list. Besides offering  a healthy and hygienic canteen facility, we provide many recreational activities for the employees.” For agri-biotech companies, the major focus is on creating a great environment for the scientists to work efficiently. Among these, Jalna-based, Mahyco, provides a pollution-free campus at its R&D center. According to Mr P L Gaekwad, vice president-HR, Mahyco, “Besides having transparent policies, we provide motivating and enabling work environment to our employees. For the benefit of the employees, we provide accommodation with amenities like gymnasium, a state-of-the-art auditorium, an air conditioned club house, and indoor and outdoor sports facilities.” Transport services & flexible timings Almost every company provides free transportation facilities to the employees for ensuring their safety. Besides the regular transport for commuting, many firms provide transport in case of emergencies. This includes air conditioned four-wheelers for employees engaged in field work. Apart from that, flexible work timings reduces the pressure on the employees. Mr G Jayaraman of Transasia Bio-Medicals says, “Along with flexible timings for reporting for duties, we provide transport facility to commute to the nearby station and back”. Echoing similar views, Mr G S Krishnan of Novozymes says, “The major USP of Novozymes is that it is a employee-friendly organization and gives employees the option to work from home, whenever required, in order to maintain a work and life balance.” A large number of agribiotech companies in India are family-run businesses and therefore, have flexible timings. These firms work based on mutual trust and rapport shared by employees with seniors. Companies like Ankur Seeds feel that the USP of their employee welfare policy is that being a family-run business, they provide an environment which makes the employee feel that he or she is a part of the family. Even the companies who are only involved in marketing and do not have R&D setup, seem to have no reservations on flexible approach on work timings as far as it doesn’t hamper productivity. With a full fledged marketing set up in India, Gurgaon-based global biopharma giant, Eli Lilly, has a generous leave policy to improve work-life balance. In a year, an employee is entitled to almost 54 days of leave, over and above the regular weekends. The company has paternity leave of five days and adoption leave as well. Health and insurance Apart from the basic facilities, such as good campus, transportation and food, the companies also ensure that the employees remain safe while doing their jobs. The 24x7 medical facility and on-site consultation remains the top priority of companies. The benefit package at Reliance Life Sciences includes a group mediclaim policy for employees and their families. Employees working in the company are also covered with accident and life insurance. On similar lines, New Delhi-based CRO, Max Neeman International, offers complete hospitalization group coverage to all its employees and their family members, to address any health related problem. Says Ms Vipra Datta, senior manager HR, Max Neeman International, New Delhi, “We offer an accident policy cover to all employees and interest free loans from the employee contingency fund are applicable to all employees in case of any tragedy.” Eli Lilly has created an all India 24x7 helpline to provide medical assistance and guidance round the clock in case of an emergency. It also provides on-site physician consultation. Mr Sameer Bhariok, director-HR, says “We have a physician to provide in-house medical consultation to our employees. Regular communication on outbreaks and epidemics is carried out to ensure that employees are well aware of the medical conditions.” Similarly, all employees at Mahyco are covered 24X7 against accidental death to the extent of their 80 months gross emoluments. According to Mr P L Gaekwad, vice president, HR, “Employees are also covered under group annual medical check-up arrangements with leading hospitals and are also covered under life insurance.” Rewards and recognition Various innovative forms of rewards and recognition of contribution is one of the key aspects in HR function. Besides the welfare policies for employees like career planning, competency development programs and rewards and recognition scheme, there are some policies which are unique to various companies. Among these is an opportunity for employees to go for higher education. Educational tie-ups with reputed institutes where employees are deputed for research fellowship program also lies on the top agenda of some companies. The employees are also sent for participating in national and international symposiums in order to enhance their knowledge base. To recognize and promote positive behavior in the employees, Reliance Life Sciences has advanced diploma programs in place, wherein the fresh graduates and postgraduates are groomed by in-house faculties and are put to classroom and on-the-job training. The company also has rewards and recognition programs like Employee of the Year, Leader of the Year, Scholar of the Year. “We also have monthly retreats, a forum where the CEO shares business performance with the employees and the staff share the latest developments in their functional areas, says Mr K V Subramaniam of Reliance Life Sciences. <big>Rahul Koul</big> in New Delhi ]]> <![CDATA[Retention strategies for changing times]]> https://biospectrumindia.com/news/95/4160/retention-strategies-for-changing-times.html https://biospectrumindia.com/news/95/4160/retention-strategies-for-changing-times.html Mon, 05 Sep 2011 12:49:00 +0530 Rapid mushrooming of biotech companies in India, fierce competition and emergence of lucrative opportunities have made HR departments across the sector chalk out innovative retention and performance evaluation strategies along with interesting training activities Biotechnology is a knowledge-driven industry, where, over a period of time, technologies become obsolete and industry trends keep changing. HR teams in the biotech space, have come to realize the need to initiate training programs in order to upgrade the skill sets of their workers and methodologies to identify critical and star performers, on a continuous basis at all levels. The attrition rate in the life sciences industry is from 20 to 30 percent. HR teams are devising strategies to retain skilled employees and maintain single-digit attrition rates by chalking out a sound performance evaluation structure, which is a barometer to an employee's productivity and contribution to the organization. Training programs Clearly, there are two categories of training programs conducted by the companies. Presently, there is an increased emphasis on developing not just technical expertise but also on improving behavioral approaches and soft skills of an employee towards his work. While induction and basic management training programs are usually imparted to freshers and new joinees, training courses pertaining to honing leadership skills, cGMP training, improvement of communication skills, employment engagement skills and stress management are some of the other focus points for the training programs. Freshers, in particular, are evaluated on a time-to-time basis during their training period. Says Mr G Jayaraman, head â€“ HR, administration and CSR, Transasia Bio-Medicals, â€œThe trainees perform under the direct guidance of the zonal heads for the initial three months, who guide them on a day-to-day basis. Evaluation is done on a quarterly basis during the training period, to understand their performance and provide objective feedback.â€? On completion of the training period of one year, their performance in the company is assessed. Those with satisfactory performance are confirmed with suitable revision in their emoluments. Those with exceptional performance are promoted to the next level with due consideration on the emoluments. In the technical avenue, Reliance Life Sciences (RLS), for instance, provides domain-specific training to employees on good manufacturing practices, good clinical practices and SAP application training. Says Mr KV Subramaniam, president, RLS, â€œIn RLS, a knowledge-based R&D organization, employees are encouraged to pursue higher studies, for which it has a tie-up with Mumbai University.â€? Bangalore-based Anthem Biosciences, apart from induction and cGMP-related training programs, also conducts on the job training and EHS programs for employees. Dr Ashwin Kashikar, deputy general manager, biotech research, Ankur Seeds, says, â€œApart from induction, in which we introduce a fresher to the company and its policy, we have conducted some training programs in research facility for new technology and also for transfer of technology programs from experienced employees to the freshers.â€? For soft skill development, companies formulate a wide array of programs depending on the need of the employees. Common programs include personality development, presentation skills, leadership development skills and team work in addition to making freshers understand the vision of the company. Novozymes has also devised programs related to lifestyle and stress management. RLS has competency-based training programs on subjects like â€œmanagement of changeâ€?, â€œself disciplineâ€?, â€œmanagement of innovationâ€? and soft skill training on topics like communication, etiquette and impression management. Conducting outbound workshops and training programs is gradually picking up prominence. This in turn has also proved to be a potent retention formula for employees. Agri-biotech companies like Ankur Seeds and Mahyco have introduced such initiatives. Adds Dr Kashikar, â€œWe send our employees to conferences and offshore training programs to keep them updated. A highly interactive session is also conducted in which we identify the need to introduce learning programs.â€? Mahyco plans to introduce such programs for freshers too, starting this year, which also includes outbound training programs. Retention With the Indian biotechnology industry hitting the $4 billion mark (BioSpectrum-ABLE survey estimates for 2010-11), there has been an increasing demand for postgraduates and doctorates, specializing in fields like biotechnology and chemistry. The sector has seen rapid mushrooming of companies, each offering lucrative career opportunities. The sales and marketing departments have witnessed the maximum retention. Says Mr P L Gaekwad, vice president, HR, Mahyco, â€œRetention of employees with less than three years of service with Mahyco is a challenge, in spite of attrition being in single digit. Constant innovation in formulating CTC package for employees, like, introduction of annual retention bonus, loyalty bonus and joining bonus, is done in deserving cases. Retention of skilled employee thus becomes a daunting task for many companies. Retention strategies for most of the companies include engaging employees in team or departmental activities, recognitions and rewards, monetary incentives on achieving targets and transparency and freedom to have one-on-one discussions with the management. Employee engagement activities is perhaps a crucial factor in retention of staff. Mr G S Krishnan, regional president, Novozymes South Asia, says, â€œThis includes encouraging employee participation from all levels in adding value to the organization and encouraging feedback and implementing the suggestions.â€? Anthem Biosciences introduced a new incentive scheme during the review process during the year 2011, wherein the incentive is paid in advance to the employees for the first six months and the other portion is paid later. Vaccine major, Panacea Biotec, devised an exciting online reporting system. Says Mr Kulvinder Sarao, VP, HR, Panacea Biotec, â€œWe have sales force automation (SFA) which is an online reporting system. This apart, we offer self-management leave system, salary on day one, open door approach, growth-linked incentive scheme and competitive salary.â€? Many companies within the sector have also introduced flexible timings to their workers, provided that they meet their KRAs and targets. Ms Vipra Datta, senior manager HR, Max Neeman International, says â€œWe have introduced â€œflexi timingsâ€?, inter and intra-departmental movements and growth, compensation benchmarking, effective training and development programs.â€? Exposure to cross functional activities, sending employees for international summits and conferences and sponsorship for management studies and higher studies are some of the other retention activities employed. Performance evaluation While for a long time, the usual performance evaluation system was the common route adopted to gauge the performance and productivity of an employee, HR departments are gradually adopting methodologies like the balance score card and the 360 degree feedback. At RLS, performance assessments are based on a balanced score card system. Says Mr Subramaniam, â€œThe balanced score card involves a set of performance objectives on financials, customers, internal business processes, and learning and growth parameters. Targets to be achieved for the year, which encompass all the above four aspects, are set out through a goal-setting exercise conducted at the beginning of the financial year. The entire process, which includes the goal setting, quarterly reviews and performance assessment, is automated and accessible through a portal called 'employee self service'. This process ensures transparency across all levels.â€? Also, the company has simultaneously also introduced the 360 degree feedback with full participation of the workers. Apart from setting KRAs for the next one year, Panacea Biotec is looking to chalk a five-year KRA for its employees. â€œWe have defined goals and objectives for the next five years and based on this, KRAs and KPIs are defined every year for each and every employee in the executive cadre. The levels of achievement indicated through KRA and KPI relate to establishing the star performers. In addition, other tools like the functional head's assessment, potential assessment and 360 assessment also indicate star performers,â€? adds Mr Sarao. Mr Sameer Bhariok, director-HR, Eli Lilly, says, â€œFor each function and level, there are separate competencies that have been defined. Based on performance and behaviors, employees are assigned a formal rating, which can help them qualify for assessment centre. The assessment committee evaluates all such nominated employees, identifies star performers and recommends further development interventions and career opportunities.â€? In some companies, identification of star performers is a joint initiative between colleagues and team leaders. Says Mr Krishnan, â€œWe have an evaluation system in place wherein, the manager and peers nominate their colleagues as the star performer of the month. Based on the maximum accumulation of such stars, an employee will qualify for the regional president's award, which is a cash incentive.â€? At the end of the day, it is these group of star performers who are catalysts towards the company's next level of growth. Working towards training and churning out a sizable number of star performers is what differentiates a good organization from a great one. Nayantara Som (with inputs from Rahul Koul) ]]> <![CDATA[The Hiring Mantra: Behavioral Aptitude Counts]]> https://biospectrumindia.com/news/95/5587/the-hiring-mantra-behavioral-aptitude-counts.html https://biospectrumindia.com/news/95/5587/the-hiring-mantra-behavioral-aptitude-counts.html Fri, 02 Sep 2011 18:04:00 +0530 With increase in competition, HR teams across biotech companies recruit freshers, not just on the basis of their technical expertise and domain knowledge but also on the behavioral aptitude of the candidate Human resource teams across the various sub-segments within the biotechnology sector, have come to realize the need to inject the much needed vigor, creativity, and above all, a fresh pool of innovative ideas into the pulse of their system. This radical transformation can come about by scouting and recruiting good quality freshers who are passing out of biotech universities and colleges. The modus operandi of selecting the cream of students from academic institutes include, meticulous methods of technical tests, interviews, group discussions, behavioral screening rounds and psychometric tests. Technical and behavioral aptitude Like its counterparts in other sectors, biotech companies, today, conduct several rounds of technical tests, group discussions and aptitude tests before short listing a final candidate. While in-depth knowledge and technical expertise about the industry is a critical factor that is often sort in a prospective candidate, companies also conduct thorough psychometric and screening tests to gauge the behavioral aptitude of a candidate. Some such attributes include decision-making skills, positivity, leadership abilities, ability to handle stressful situations, efficient communication skills and managerial skills, apart from the candidate's extra-curricular activities during his academic tenure. HR officials across different companies claim that although, these processes are time consuming, at the end of the day it is worth the effort. Mr KV Subramaniam, president, Reliance Life Sciences (RLS), says, â€œRLS looks for candidates with conceptual clarity on the subject, analytical ability and ability to apply the gained knowledge. Also essential are creative thinking, good communication skills, leadership abilities and confidence. Hence, several rounds of HR and technical interviews are conducted. Even though this is time consuming, it has helped to build an environment favorable for building the capabilities of the organization and employees.â€? College Recruitments 2010-2011 Company College Transasia Bio-Medicals Amity, Symbiosis, IBS, DY Patil, Thadoomal, Auroprobe Reliance Life Sciences Reliance Institute of Life Sciences (RILS) initiated two programs - Young Professionals Program and Advance Diploma Programs Zytex UDCT Jalgaon Ankur Seeds PKV, Nagpur Max Neeman International Amity University; Balaji Institute of Management; Institute of Clinical Research India; MS University, Baroda; Punjab University, Chandigarh; Delhi University Novozymes South Asia IBAB, Bangalore Mahyco NIAM-Jaipur, VAMNICOM-Pune, IIPM-Bangalore, MANAGE â€“ Hyderabad, IABM-Bikaner Anthem Biosciences Christ College, RV College & St Joseph Reliance Institute of Life Sciences (RILS) rolled out a 'Young Professionals Program' (YPP), wherein fresh graduates and postgraduates in life sciences or related fields are inducted through national level tests and interview. They undergo three months' classroom training and nine months' on-the-job training at Dhirubhai Ambani Life Sciences (DALC) campus. On the successful completion, they are absorbed in various business domains within RLS. So far, almost 12 such programs have been conducted. RILS also initiated advanced diploma programs, which are of six months or one year duration. These programs enable fresh postgraduates and graduates to be groomed by in-house faculties and helps them to undergo classroom and on-the-job training. At the end of the program, they are awarded diploma certificates by the Reliance Institute of Life Sciences. Depending upon the requirements at RLS, these students are by and large absorbed in various functions, through standard selection process. Around 14 freshers were recruited into the company this year through these two programs. Gurgaon-based multinational biopharma company, Eli Lilly, recruits around 80 freshers every year from premier pharmacy colleges and management institutes across the country. The HR team, apart from testing domain knowledge, has adopted the Thomas profiling methodology, which is used to gauge the personality of a potential candidate, in order to select the right individual for the job. Agri-biotech company, Maharashtra Hybrid Seeds Company Limited (Mahyco), which apart from conducting the usual group discussions and personal interview rounds, also conducts Thomas profiling exercises. New Delhi-based CRO, Max Neeman International, recruits around 90 freshers every year. Says Ms Vipra Datta, senior manager, HR, Max Neeman International, â€œWhile hiring candidates, we look at qualities like positive attitude, willingness to work and learn new concepts, technical skills and soft skills. We have technical questionnaires and structured interview questionnaires as a part of the hiring process to select the right candidate.â€? There has been a growing demand amongst students to opt for jobs in the agri-biotech sector, both in core technical departments and job roles requiring a management graduate background. Mr P L Gaekwad, vice president, HR, Mahyco, says, â€œWe have been to five-six institutes like, the Indian Institute of Plantation Management (IIPM) and the Institute of Agri Business Management (IABM), Bikaner. This year we are looking to spread across the country and visit 10 more colleges for campus recruitments.â€? The Jalna-based company recruited 19 freshers this year. Nagpur-based, Ankur Seeds, went to campuses like PKV, Nagpur, and recruited 40 freshers. There have, however, been companies, who are yet to start recruiting freshers from campus placements but will gradually roll out the process in the near future. Reasons include, preference for experienced professionals in the sector, lack of specialized courses or colleges for a particular sub-segment or the company might be in a situation when it is just setting up new operations in the country. Novozymes South Asia, for example, is in the process of setting up new processes and functions in India and hence they have not yet started campus recruitments yet. So far, the Institute of Bioinformatics and Applied Biotechnology (IBAB) is the only institute from where they have recruited freshers this year. Mr G S Krishnan, regional president, Novozymes South Asia, says, â€œWe did not have a rigorous campus recruitment program until now, as we are setting up new functions in India, which requires experienced professionals to incubate these functions locally. Once the new functions are set up to an extent that we have enough expertise to train fresh recruits, we would increasingly approach campuses. We are hoping to start in 2012 and as a step towards this initiative we have recruited project trainees.â€? The challenges of quality students Are universities churning out quality students? There are two schools of thought pertaining to this issue. A set of experts believe that the situation has changed for the better, and universities and schools are taking initiatives to train and groom students to fit into the corporate culture. Mr G Jayaraman, head-HR, administration and CSR, Transasia Bio-Medicals, says, â€œColleges do provide adequate number of quality students. Some select institutes give adequate hands-on exposure by providing technical training, as a part of academic syllabus. Institutes such as Amity and Symbiosis focus more on soft skills training than technical aspects. Agrees Mr Gaekwad, â€œFor the agri-biotech sector, we do get quality students every year. Institutes have a common entrance test from where the best students are chosen for the courses. The students we have recruited have met our expectations.â€? Given their technical expertise, companies believe that students merely need proper guidance and training in order to fit into the corporate culture. Induction and training programs is a step towards achieving this goal. Mr Sameer Bhariok, director-HR, Eli Lilly, says, â€œTraining vistas not only cover the basic requirements of everyday job, but also empahize on continually developing a person holistically, which includes honing soft skills too. We develop the right people through consistent and timely interventions, utilizing latest technologies that enable people to grow.â€? Another group of experts believes that there is a huge gap in demand and supply of freshers, due to which a large chunk of their resources go in training freshers to meet their standards. Lack of specialized courses in the country is a contributing factor towards this problem. For instance, niche skills set for the enzyme industry is yet to be initiated in the country's academic institutes. â€œThe niche skill sets and education in enzyme technology are subjects not taught in many Indian institutes, thus there is a skill set gap. We have very few PhD students opting for courses in enzyme technology in India,â€? says Mr Krishnan. Mr MG Shembekar, managing director, Ankur Seeds, says, â€œFor agriculture and biotech industry, there has always been a gap for freshers in what they learn at colleges and university and what the industry actually needs.â€? Taking this into consideration, the Department of Biotechnology (DBT) has facilitated industrial training programs for postgraduate students to reduce the gap between the industry expectations and students produced by universities under a consortium called the Biotech Consortium India Limited (BCIL). Industry experts opine that it is a positive sign. The government of Karnataka has taken the lead by supporting 12 BT Finishing Schools (selected by a committee comprising members of the Assosiation of Biotech Led Enterprises (ABLE) and academicians) in the state, by providing them with financial support of upto `1 crore, which are expected to produce industry-ready persons for employment in the biotech sector. Says Mr Shembekar, â€œThere are very few universities in India with good research facilities, which provide quality students, but the kind of initiative taken by the BCIL for providing industrial training to the postgraduate freshers is a positive step in filling up the gap.â€? Nayantara Som in Mumbai ]]> <![CDATA[Biotech education grows slowly]]> https://biospectrumindia.com/news/95/3024/biotech-education-grows-slowly.html https://biospectrumindia.com/news/95/3024/biotech-education-grows-slowly.html Fri, 02 Sep 2011 18:03:00 +0530 Every industry needs talented human resources to sustain itself and grows. For the $4 billion Indian biotechnology sector, the requirement is even more than the other industry segments in terms of talent, as one would expect from knowledge-based industry. The 500 educational institutions, majority of which were set up in the past decade, are the heart beats of the vibrant industry. So, the status of the biotech sector is the focus of the third volume of the annual biotech industry surveys conducted by BioSpectrum. The results of the 7th BioSpectrum BT Schools Survey are presented in this issue of the magazine. Every year, 25,000-30,000 eager students are enrolling for the numerous BTech and postgraduate courses in biotechnology disciplines in 500 institutions in the country. The BioSpectrum survey indicates that some 100,000 students are enrolled currently in biotechnology courses. Thanks to these students, biotech education is now a 1,150-crore annual market. It grew by 9.5 percent during 2010-11. The annual intake of the industry is in the range of 8,000-10,000 new employees. Yet, nearly three times this number of students are reposing their faith in the growth prospects of India's biotech industry and aiming for a career in biotechnology. So what happens to the ones not hired by the industry? BioSpectrum estimates indicate that a third of the students who complete biotech courses in the country are enrolling for higher education both within and outside the country. Another third are absorbed by the information technology industry whose appetite for fresh brains continues to be huge. Only the remaining third gets into the biotech industry. The top ranks in the public institutions category had changed in the first five years of the survey. For the first time, ICT, Mumbai, is No.1 for the second year in running. In the private institutions category, the musical chairs continue and Sastra University, Thanjavur, is back as No. 1. Some of the prominent institutions, both in public and private categories, which were part of the rankings last year, could not join the survey this year due to time constraints. Their names have been indicated in the survey highlights. Many readers will be wondering about the absence of some of the high-profile private institutions who are not featured in the rankings. A prominent biotechnology institution in the National Capital Region put a stiff condition to participate in the survey: a guaranteed top rank for consideration. Another equally prominent institution in Chennai region too has opted out of the survey in the last two years on a similar demand. The integrity of BioSpectrum's editorial is of paramount importance. Even a blank cheque cannot influence the survey processes whose credibility is the greatest asset of the magazine. There is a Chinese wall that separates the editorial and marketing operations of the magazine and it will not become porous under any circumstances. I advise the discerning readers of BioSpectrum to be wary of such institutions that overstate their strengths. The results of this survey are for the student community to evaluate the institutions based on credible information gathered by the magazine. I wish all the 58 institutions who participated wholeheartedly in the BT Schools survey and I am sure the future biotechnologists and the industry will benefit immensely once again from the invaluable information provided here. Happy reading! Narayanan Suresh Chief Editor sureshn@cybermedia.co.in ]]> <![CDATA[DBT, Piramal Life Sciences tie-up]]> https://biospectrumindia.com/news/95/2635/dbt-piramal-life-sciences-tie-up.html https://biospectrumindia.com/news/95/2635/dbt-piramal-life-sciences-tie-up.html Fri, 02 Sep 2011 17:58:00 +0530 The Department of Biotechnology (DBT), Government of India, and Piramal Life Sciences have begun phase II of their drug discovery public private partnership to find new drugs from 14,000 bioactive cultures discovered in a nationwide search for new drugs from biodiverse habitats across the country in collaboration with nine national institutes. During the phase I of the program, which is jointly funded by the DBT and and Piramal Life Sciences, a total of 245,000 different microbes were collected and characterized at the national centers. Extracts from these microbes were screened for biological activities across four different therapeutic areas - cancer, diabetes, inflammation and infectious diseases. Based on the results of these studies, the team has identified greater than 14,000 cultures that showed potent activities in the above disease conditions: 5,000 extracts for anti-infective, 500 extracts for anti-cancer, 6,000 for anti-diabetes and 2,900 extracts with anti-inflammatory properties. All these cultures are in the process of classification and storage in a national repository created by the DBT at the National Centre for Cell Science. Innovative research at KIIT University Bhubaneswar-based KIIT-technology business incubator at KIIT University is working on many innovative concepts supported by the Department of Science & Technology, Govt of India. The team headed by Dr Mrutyunajy Suar includes Mr Vikalp Viswakarma and Mr Niladri Bhusan Patia. The team is trying to develop the safest vaccine to provide protection against several diarrheal diseases caused by bacterial pathogens Salmonella, Shigella, E. coli and Vibrio cholera. This is being tested in mice and has shown promising results so far. Dr Suar and Mr Satyapriya Jena have also developed a multiplex PCR protocol to identify the causative agents of diseases within two hours. Focusing on the rural mass, such tests are being developed at very low price.Also, Ms Regalin Rout and Prof Peter Luthy at KIIT identified and isolated unique bacterial strain from the agricultural fields that is highly active against the larvae of Culex, Aedes and Anopheles. Conference held on managing BT crops At the round table conference organized by The Energy and Resources Institute (TERI) at New Delhi, the experts from academia and industry discussed various burning issues on the management of biotech crops. TERI organized the conference titled â€œManaging Biotech Cropsâ€? (July 4-5, 2011) in New Delhi. The conference witnessed detailed discussion between policy makers, experts from research institutes and industry representatives. There was an overall consensus among experts on the improvement of effective science communication, dissemination of knowledge on biotech crops, and the re-look on the regulatory mechanisms. The two-day conference witnessed technical sessions on sustainability of food production, genetic improvement of crop plants, choices of usage, global acceptability and lack of harmonization of regulatory laws, good agricultural practices and developing risk assessment & management procedures. The concluding session was chaired by Dr M K Bhan, secretary, Department of Biotechnology. Indo-US partner in biotech research The Stanford India Biodesign program has resulted in 20 patents being filed and several proto-types of affordable bio-medical devices and technologies developed that are at various pre-commercialization stages. Minister of State for Science and Technology and Earth Sciences Ashwani Kumar, at INDO-US Science and Technology Innovation Expo in New Delhi on July 19, said the two countries will take this forward. India and the US will also partner to address challenges of wheat genome sequencing; human genetic-genome analysis; stem cell research; nano biotechnology; plant breeding technologies and food security; micro-electronics and material science technology; nano science and supercomputing. Aeras, CNBG MoU for TB vaccines Aeras and the China National Biotech Group (CNBG) have signed a memorandum of understanding for the organizations to jointly develop tuberculosis (TB) vaccines in China and other parts of the world. The partnership is intended to leverage both organizations' capabilities to support the development of TB vaccines. The scope of potential activities will cover the full spectrum of product development, including pre-clinical development, process development and manufacturing, and clinical development in TB and potentially other disease areas. Details of the specific activities and areas of focus of the collaboration will be set forth in a future definitive agreement. ]]> <![CDATA[India becomes GLP compliant]]> https://biospectrumindia.com/news/95/2716/india-becomes-glp-compliant.html https://biospectrumindia.com/news/95/2716/india-becomes-glp-compliant.html Fri, 02 Sep 2011 17:54:00 +0530 In a move welcomed by the industry and regulatory bodies, India, after continuous efforts of nine years, has managed to get the status of full adherence to Good Laboratory Practices (GLP). This international recognition was eagerly awaited by industry and is expected to eliminate the technical barriers to trade. With India achieving the status of full adherence to GLP, the manufacturers of pharmaceuticals and agro products will no longer have to get the mandatory tests done overseas. The GLP is certified by the Organization of Economic Co-operation and Development (OECD). The 34-member OECD includes some of the world's most advanced countries such as the US, UK, Canada, Australia, Sweden, Switzerland, Denmark, Hungary and Korea. The recognition has come after continuous efforts for nine years after National GLP-Compliance Monitoring Authority was set up in 2002. Agri-R&D budget needs to increase: PM Prime Minister of India, Dr Manmohan Singh, has emphasized on the need to spend more on agricultural research. While delivering the 83rd foundation day lecture of the Indian Council of Agricultural research and award ceremony on July 16, 2011, at New Delhi, the prime minister talked about the need to increase the budget for agricultural research. â€œIndia currently spends about 0.6 percent of its agricultural GDP on agricultural research and development. This needs to be enhanced two-three times by 2020 since a substantial portion of our agricultural growth would come through the application of new technologies and new knowledge,â€? said Dr Singh. He also emphasized on careful application of biotechnology to improve productivity, enable better resilience to stress and also enhance the incomes of farmers. Gilead expands global access program The US-based pharmaceutical company, Gilead Sciences, has expanded its global access program in an effort to provide accelerated access to Gilead medicines for the treatment of HIV/AIDS. The changes announced include new licensing terms with four India-based drug manufacturers - Hetero Drugs, Matrix Laboratories, Ranbaxy Laboratories and Strides Arcolab - for three drugs which are currently in late-stage clinical development. These Indian partners have played an active role in supplying treatment to patients in the developing world. In addition, Gilead is the first pharmaceutical company to enter a licensing agreement with the Medicines Patent Pool Foundation. The expanded licensing terms grant to the company's Indian partners and the Medicines Patent Pool Foundation future rights to elvitegravir, an investigational integrase inhibitor; cobicistat, an investigational antiretroviral boosting agent; and the â€œQuadâ€?, which combines four Gilead HIV medicines in a once-daily, single-tablet regimen. Gilead licensed rights to commercialize elvitegravir from Japan Tobacco (JT). JT is working in close partnership with Gilead to ensure future access to elvitegravir in the developing world. Biotech education hubs in North East The Department of Biotechnology, Ministry of Science & Technology, has initiated the process of establishing biotech hubs under a special program. The institutions will be identified by the DBT for providing necessary infrastructure support for teaching and research activities, and will be funded accordingly. Each biotech hub will be looked after by a coordinator to be nominated by the host institute and guided by a small committee constituted as per the guidelines framed by the DBT. The host institution will have to provide necessary space and accommodation. The initial support will be for three years. The broad purpose of the program is to promote education and research in various branches of life sciences, including biotechnology, to attract students. GEAC rejects Mahyco's appeal The Genetic Engineering Appraisal committee (GEAC) has rejected the appeal from Jalna-based hybrid seeds company, Mahyco, to reconsider its decision on using non-Bt cotton hybrids as refuge. The appeal from Mahyco came against the decision of GEAC regarding the use of non-Bt RRF cotton hybrids containing cp4epsps gene (event Mon 88913) as refugia during Biosafety Research Level (BRL)-II trials. Considering the fact that GEAC has rejected the approach taken by Mahyco to conduct trials, the company has no option but to go for fresh round of BRL-II trials. Moreover, the company has also been asked by the GEAC to strictly adhere to the protocols approved by it for conducting the fresh trials. ]]> <![CDATA[Axis turbulence hits India's CRO industry]]> https://biospectrumindia.com/news/95/3499/axis-turbulence-hits-indias-cro-industry.html https://biospectrumindia.com/news/95/3499/axis-turbulence-hits-indias-cro-industry.html Thu, 25 Aug 2011 14:27:00 +0530 India's fast-growing CRO industry is apprehensive of a backlash against the sector after the regulatory action taken against Axis Clinicals for its misconduct The regulatory action to shut down the key operations of Hyderbad-based Axis Clinicals over unethical practices detected in its recent clinical trials of an anti-cancer drug, has sent shockwaves through India's 3,246 crore(BioSpectrum-ABLE biotech industry survey 2011) CRO ( clinical research organizations) industry, just when it was angling for a greater global role. What has come as a major shock is that the delinquent CRO company, Axis Clinicals is closely associated with one of India's well-respected pharma majors, the 4,381 crore Aurobindo Pharma. Axis Clinicals, incorporated in September 2004, is promoted and run by Mr Sarat Chandra Reddy, son of the Aurobindo Pharma's chairman, Mr P V Ramprasad Reddy. Though Axis is not a group company of Aurobindo Pharma, the younger Reddy is a non-executive director on the board of the publicly-listed pharma major. The issue led to an emergency meeting on July 29, 2011 of the Association of Clinical Research Organization (ACRO). Industry leaders have come out in full support of the regulator's stringent action which was required in the overall interests of the industry. At the same time, the Association requested the government not to harm the industry's interests due to the actions of one black sheep in the sector. Axis is not an associate company of Aurobindo. But Axis is treated as one of the enterprises in which Aurobindo's key management personnel or relatives exercise significant influence. BioSpectrum's attempts to get Axis' side of the whole issue so far has not materialized till the time of going to press. Following media reports about the unethical practices of Axis Clinicals, the regulator, the Drugs Controller General of India (DCGI), suspended the operations of the Hyderbad company. Axis has been banned from conducting bio-availability(BA) and bio-equivalence(BE) studies at its Miyapur center in Hyderabad. The company was accused of following incorrect patient enrolment process, trials without prior consent and use of a non-independent experts committee to oversee clinical trials. Though the company conducts over 70 trials in a year, what has got Axis Clinicals into trouble is the use of poor women as subjects in the trial for anti-cancer tablet Exemetasane conducted from January 27 to February 15, 2011, in Piduguralla town of Andhra Pradesh. Apparently, the women volunteers were not informed about the true nature of the study. What is troubling the CRO industry is that this particular incident has made the regulator look at the entire industry with distrust. Approval for routine clinical trials are not forthcoming as the regulator takes a cautious stance. The bad news about Axis has spread far and wide and the Indian clinical trials industry is now looked at with suspicion by sponsors. â€œThis incident has badly affected the industry like never before. For the last two months, things have been moving very slowly and new permissions for conducting studies have not been given. The DCGI is now asking for more data, stability reports and more additional information,â€? lamented industry veteran S P Vasireddi, CMD of another top CRO, Vimta Labs, Hyderabad. Mr Vasireddi feels that the Axis incident has been hyped up by the media and the involvement of human rights organizations, politicians, middle and senior levels of bureaucracy have added new dimensions to the problem. The regulator is quick to allay the fears of the industry. When contacted by BioSpectrum, Dr K Bangarurajan, deputy drugs controller of India, New Delhi, informed that only one company (Axis Clinicals) was suspended from conducting all BA and BE studies at its center in Hyderabad. â€œWe have not suspended other firms from carrying out clinical trials in the country. However, he added, â€œIf DCGI receives any complaint against any firm violating the rules, we will act upon it.â€? â€œThis move has definitely impacted the CRO industry in India because post this incident, the DCGI is not giving any approval to conduct bioequivalence studies for foreign companies. Companies in India mainly depend on foreign clients for their business,â€? said Dr Arun Bhatt, president, Clininvent Research, Mumbai. As far as corrective measures are concerned, he said, â€œThere are three aspects that need to be seriously looked upon by the DCGI- the methodology registration of trials, regular inspection of sites by inspectors and lastly, an independent ethics committee.â€? While the industry is worried about the immediate slow down on approvals of clinical trials in the short term, there is considerable support for the regulatory action which is seen as a long-needed corrective measure. â€œIt is good for study participants, CROs and sponsors that the clinical trial practices are being checked. It is expected that if gaps are found, there is an opportunity and reasonable time given to the service provider to explain. Sensationalizing the action of a few non-compliant units and ignoring good compliant work being done by most CROs should be avoided,â€? said Mr D A Prasanna, CMD of Ecron Aucnova, Bangalore. â€œEthical testing is essential to bring new drugs to market. India is playing a big role bringing cost-effective drugs to the patients in India and the world. Such work benefits society and we need to encourage the same in India and in the world,â€? he added. Dr Milan Satia, CEO, Ethicare Clinical Trial Services, Ahmedabad said, â€œThe decision probably is right and this is a step forward for implementation of Good Clinical Practices in the country. First step should be self-disciplinary approach by CROs towards the implementation and management of all good practices because they are playing with human life and therefore, utmost care in every aspect is required.â€? Axis had a seven-member ethics committee comprising three doctors, two scientists, a lawyer and a company official as member secretary. When contacted Prof P Reddanna, who was one of the members of the ethics committee of Axis Clinicals for the last three years, said, â€œFrom recruitment of volunteers to data gathering process, we ensure that all guidelines are adhered to.â€? Prof P Reddanna, who is currently heading the National Institute of Animal Biotechnology, a central government initiative, as officer on special duty, raised doubts about the role of some NGOs, and observed â€œThis is because of a misconception among the public about BA and BE studies and clinical trials. And people, who are in need of money are re-registering as volunteers in less than three-to-four months.â€? Another ethics committee member, Mr Ramakrishna, who has been working as secretary of the ethics committee for the last seven years with Axis Clinicals said, â€œSo far, Axis Clinicals has done over 350 BE/BA studies since 2004 for Indian and foreign pharma companies. The committee, headed by Dr N Srinivas Rao, professor of medicine, department of general medicine, Osmania Medical College, used to meet two-to-three times in a month. During each meeting the committee used to approve two-three molecules for conducting studies.â€? The turnover of Axis Clinicals in 2010-11 is estimated to be around 70 crore. Nearly half of it, 34.46 crore is from Aurobindo Pharma for clinical services provided to the pharma major. This was a 12-fold jump over previous year's 2.7 crore business from Aurobindo. Interestingly, Axis Clinicals trumpets that it has state-of-the-art facilities with 500+ dedicated full-time professionals to ensure quick turnaround time with high quality. Its facilities are accredited by DCGI, NABL (National Accreditation Board for Testing and Calibration Laboratories) and inspected by US-FDA, UK-MHRA, Brazil-ANVISA and France AFSSAPS and conforms to ICH and CDSCO-GCP & GLP Guidelines. The firm further noted that it has completed more than 10 years of regulatory audits from global competent authorities till mid-2011. ]]> <![CDATA[46-50]]> https://biospectrumindia.com/news/95/1995/46-50.html https://biospectrumindia.com/news/95/1995/46-50.html Mon, 11 Jul 2011 12:51:00 +0530 Raj Analytical Services Rides on chromatographic supplies Raj Analytical Services is engaged in importing and supplying of chromatography items and accessories in India. Incorporated in 1992, the company supplies a wide range of chromatography products that include gas chromatograpgy, flash chromatography, HPLC, autosampler, instruments, TLC, autosampler, standards and liquid handling products among others. The company clocked an estimated revenue of 4 crore in FY 2010-11. In tune with the company's belief for compliance to the customer's and market's needs, Raj Analytical has maintained a good inventory for immediate deliveries. Few of the principals of the company are ZirChrom, Poly LC Inc, CERI, Hamilton, Chemco, Polymer Laboratories and Varian. According to Raj Analytical, its strength lies in the fact that it offers all round technical support to the chromatographers in terms of troubleshooting and application support. MD Taranjeet Singh Bhuee 46 Business: Distributor of chromatography consumables Start-up Year: 1992 Address: Plot No.-501, Industrial Focal Point, Phase Ix, Mohali, Sas Nagar, Punjab-160062 Tel: +91-172-2213559, 5053375 Fax: +91-172-2234077 Website: www.rajanalytical.com Revenue: 4.00 crore* Lablinks Biotech Lablinks leverages on new patents Lablinks Biotech designs and manufactures equipments, bioreactors, custom-built roller bottle equipment with built-in incubators, disposable bioreactor systems of patented design, blotting manifolds and filtration systems for biotechnology laboratories and the industry. The company recorded sales revenue of 3.6 crore in 2010-11 as compared to previous year's sales of 3crore. It is also constructing an application laboratory at Hoskote Industrial estate, near Bangalore, India. Lablinks has been successful in developing import substitution for a number of critical equipments. Major customers of the company include prestigious institutions like Pasteur Institute of India, the Indian Institute of Science, Sun Pharma, Intervet laboratories, GB Pant University and Mediclone Biotech among others. Lablinks has launched an advanced version of the disposable bioreactor, the patent for which is still pending. Director Mr Amit Dahiya 47 Business: Supplier of instruments Start-up Year: 1989 Address: C-16, KSSIDC Industrial Estate, Hoskote, Bangalore-562114 Tel: +91-80-32440830 Fax: +91-80-27904790 Website: www.lablinksbiotech.com Revenue: 3.60 crore Andel Equipment Andel optimistic about future growth Andel Equipment is a manufacturing company that has high class engineering operations and rigorous quality control systems. Established with an aim to provide the best biotechnology equipments to research laboratories, bio-pharma, bio-agri industries for pilot to large scale production, the company has been able to carve niche for itself in the supplier segment. In FY 2010-11, the company registered life sciences revenue worth 3.50 crore. Andel is highly optimistic regarding its future growth and has projected a revenue of 10 crore for the current financial year. The company also has expertise in essential oil distillation units and solvent extraction units under technical collaboration with CSIR lab-Institute of Himalayan bio resource technology, Palampur. Andel Equipment has also ventured into laboratory ultra pure water purification systems and emerged as a key supplier in a short period of time by offering quality products at an economical price.small> MD Mr Anu Bhutani 48 Business: Suppliers of lab fermenters, pilot scale fermenters and industrial scale fermenters Start-up Year: 2006 Address: 298, Industrial Area, Phase-9, Mohali-160062 Tel: +91-172-2213861 Fax: +91-172-2214034 Website: www.andelindia.com Revenue: 3.50 crore Bio-Age Life Sciences Bio-Age sets focus on R&D Bio-Age Equipment and Services is an ISO 9001:2008 certified company involved in manufacturing, sale and after-sale services in the areas of industrial biotech products like fermenter and water purification systems among others. In FY 2010-11, the company reported a revenue of 2.95 crore as compared to 2.85 crore in FY 2009-10. Bio-Age has made collaborations with foreign companies for trading their products, including Grant Instruments, UK; Picodrop, UK and E-Chrom Tech, Taiwan. It also provides hands on practical training on fermentation and water purification system technology to students, faculty as well as company executives of related industry. Bio-Age has just concluded its research work in collaboration with the Department of Biotechnology, Punjab University, Chandigarh, under which two patents were filed on lipase-esterases-catalyzed synthesis of alkyl esters by the transesterification production. CEO Mr Shashi Kumar Rana 49 Business: Distributor of life sciences equipments Start-up Year: 2004 Address: S.C.O. No.1, Phase 9, Industrial Area, Mohali-160062 Tel: +91-1072-5095350 Fax: +91-172-5095350 Website: www.bioageindia.com Revenue: 2.95 crore Pooja Lab Equipments Ventures into green technology Pooja Lab Equipments, which is based in Mumbai, clocked revenue of 1.9 crore in FY 2010-11 as compared to 1.5 crore in 2009-10. Pooja Labs caters to research institutes, educational institutions and life sciences companies. Some of its clients include the Tata Institute of Fundamental Research, Mumbai; the Indian Institute of Technology, Mumbai; Bhabha Atomic Research Centre, Trombay; Central Institute of Cotton Research, Nagpur; University of Pune; Department of Atomic Energy, Hyderabad; Ion Exchange India, Hyderabad and USV Limited. Some of the products that the company manufactures, include glass door refrigerator, O D incubator, plant growth chamber, stability chamber, environmental test chamber, lab oven, lab equipments and seed germinators. Keeping in view of the growing global demand for a clean and green environment, the firm started manufacturing ecoâ€“friendly refrigeration equipment. CEO Mr GG Pillai 50 Business: Manufacturers of scientific instruments and lab equipments Start-up Year: 1999 Address: 22, Gr. Floor, Bhandup Industrail Estate, Pannalal Compound, LBS Marg, Bhandup (W), Mumbai - 400 078. Tel: +91-22-25968723 Fax: +91-22-25968546 Website: www.poojalabequips.com Revenue: 1.9 crore* ]]> <![CDATA[41-45]]> https://biospectrumindia.com/news/95/5918/41-45.html https://biospectrumindia.com/news/95/5918/41-45.html Mon, 11 Jul 2011 12:49:00 +0530 Techpharma Systems Thrives on exclusive associations Hyderabad-based, Tecpharma Systems, supplies scientific instrumentation and applications to the pharmaceutical industry, drug discovery and life sciences firms. The company reported sales of `9.50 crore in 2010-11 when compared with `6 crore from its life sciences products in 2009-10. The company represents many international companies in India such as Nickel Electro, Precision Systems, Dyets, Zhicheng Instruments, Fengshi, Centron, Cgpnc, Sca Dry and Haier among others and offers a wide range of products like blood bank equipment, liquid nitrogen containers, independent ventilated cages, centrifuges, scientific rotary evaporators, medical freezers, magnetic stirrers, water baths, osmometers, electrophoresis equipments, geldoc systems, transilluminators, animal behavioral equipments, microbiotech microdialysis, microdialyser equipments and bio safety cabinets. CEO Mr Korripati Pullaiah 41 Business: Supplier of scientific instruments Start-up Year: 1997 Address: Tecpharma House, Plot No.115, Brindavan Estate, Nizampet Road, Kukatpally, Hyderabad-500072 Tel: +91-40-23061666 Fax: +91-40-23062077 Website: www.tecpharma.co.in Revenue: 9.50 crore Biohouse Solutions Makes its presence felt with service Axiom Biotek, which has a vast experience of working under the “Uniline Group”, has offices located at 17 different locations in India. The company reported revenue of `8.80 crore in FY 2010-11 and is expected to witness a good growth in the coming years. The company has made its presence in the industry through sustained efforts and by providing cutting edge services for its customers. Axiom represents products from companies like Steris Corporation, US; Integrated Containment Systems, US and CSK-Bio, Switzerland. The company has established its base in India with a large number of installations and is offering best after-sales support to its customers. Axiom also represents other major manufacturers like Biozone Global, Aquatic Habitats, US; AIMS US; Lilico Biotechnology, UK. The company provides systems for metabolic, behavior and toxicological research to support the new drug discovery research systems from TSE-Systems, Germany. Director Mr Amit Dahiya 42 Business: Distributor of life sciences research products Start-up Year: 2004 Address: 198/23 Uniline House IInd Floor, Ramesh Nagar, East of Kailash, New Delhi -110065 Tel: +91-11-46579762 / 46661111 Fax: + 91-11-26481469 Website: www.axiombiotek.net Revenue: 8.80 crore Chromous Biotech Leverages on biology research Chromous Biotech produces reagents, enzymes and kits for all related areas of biology research. This includes PCR enzymes and reagents, restriction endonucleases, DNA/RNA ladders, research kits, teaching kits, small laboratory instruments and plastic consumables. The company has registered biotech sales revenue of `5.5 crore in 2010-11 as against previous year’s sales revenue of `5.02 crore. Chromous Biotech has achieved  success in the industry by focusing on flexi packs, fast delivery and customer-care. Located on a 6,000 sq ft laboratory floor space, the company, at present has 72 employees. Contract research services have been its strength with customers from prominent research institutes and universities apart from a few pharma companies in India. The company has offices in major cities like Bangalore, Mumbai, Delhi, Kolkata, Hyderabad and Chennai and has business activities in other parts of India. CEO Dr Biswajit Roy 43 Business: Molecular biology related services and production Start-up Year: 2006 Address: # 842, IInd floor, Sahakara Bhavan, A Block, Sahakarnagar, Bangalore 560092 Tel: +91-80-23620050/ 40901749 Fax: + 91-80-23625647 Website: www. chromous.com Revenue: 5.50 crore Marsap Aids preclinical research Marsap Services is a distributor of high-tech analytical instruments in India with special focus on drug discovery preclinical research. The company has been operating in the biotech sector for the past 14 years. For fiscal 2010-11, the company clocked revenue sales of  `4.50 crore. The revenue from the private sector is 60 percent and the remaining is from the public sector. Last year, the company saw a drop in its sales due to the slowdown in investments from pharmaceutical companies into R&D activities. The company installed 80-90 instruments during the fiscal. For the coming year, it is looking at a growth rate of 30 percent to make up for its drop  in sales in the last fiscal. In the drug discovery segment, the company focuses on instruments used for pre-clinical research and covers almost the entire spectrum of activity from animal housing to safety pharmacology. CEO Mr Gautam Rajan 44 Business: Distributors of analytical instruments for preclinical research Start-up Year: 1974 Address: 29, Ujagar Industrial Estate, W.T.P. Road, Deonar, Mumbai 400088 Tel: +91-22-25516908, 25555137 Fax: +91-22 25563356 Website: www.marsap.com Revenue: 4.50 crore Future Bioscience Eyes lab instrumentation segment                     The company has registered sales revenue of `4.4 crore in 2010-11 as against `3.5 crore in 2009-10. Founded in 2005, Future Bioscience has been supplying plastic disposables, tissue culture ware, chemical reagents, liquid handling systems, molecular biology equipments including electrophoresis, spectrophotometers, micro plates readers, manual sequencers to the industry. The company has collaborated with the global giants TPP, HTL and Cleaver Scientific for a range of tissue culture and laboratory products, liquid handling laboratory tools and electrophoresis and related products. Last year, the company tied up with US-based Biocision, which has come up with the latest technology products for benchtop cooling racks and trays for PCR techniques and cell storage handling. The company collaborated with two companies in 2011 namely, Sorenson and Metertech for providing different range of lab instrumentation. CEO Navneet Trehan 45 Business: Biotechnology research products Start-up Year: 1999 Address: 136, C-Block, Community Center, Plot No. 32 to57, Behind Janak Cinema, Janakpuri, New Delhi-110058. Tel: +91-11-25571190 / 91 Fax: +91-11-25571192 Website: www.futurebioscience.net Revenue: 4.40 crore ]]> <![CDATA[31-35]]> https://biospectrumindia.com/news/95/1992/31-35.html https://biospectrumindia.com/news/95/1992/31-35.html Mon, 11 Jul 2011 12:43:00 +0530 BI Biotech Maintains consistent growth As a distributor of research reagents, consumables and equipments for proteomics, genomics, cell biology, immunology, healthcare and drug development, BI Biotech India has developed a niche space for itself in the supplier segment. The company registered sales revenue worth 16.71 crore in 2010-11 as compared to the previous year’s revenue of 14.04 crore. The company  represents several US-based companies like Anaspec, Bellco Glass, GlobalStem, R&D Systems, RayBiotech, Santa Cruz, SABiosciences Corporation and USA Scientific. Besides these, it also distributes products from Abnova Corporation, Taiwan; Bachem AG, Switzerland; Cedarlane Laboratories Limited, Canada; Major Science, Taiwan and IKA, Germany. One of the factors behind its success is the firm’s focus on providing good warehousing for perishable reagents like ELISA kits, recombinant proteins and antibodies among others. MD Mr Vinaya K Dubey 31 Business: Distributor of research reagents and instruments Start-up Year: 1984 Address: 325, 3rd Floor, Ansal Chambers, Bhikaji Cama Place, New Delhi-110066. Tel: +91-11-2610271 Fax: +91-11-2610273 Website: www.biotechindia.com Revenue: 16.71 crore Sisco Research Laboratories Specializes in pure chemicals Sisco Research Laboratories (SRL) is a manufacturer and supplier of highly pure specialty chemicals for the biotechnology and research industry in India.  The company increased its revenue from 5.3 crore in 2009-10 to 15 crore in 2010-11. This significant rise in the revenue is mainly attributed to the addition of several high value products of special research needs, such as nanotechnology powders and carbon nanotubes. Furthermore, it has tied up with five leading specialty chemical manufacturers from Europe and the US and also introduced another arm to the company. As of last year, around 70 percent of Sisco’s revenue was obtained from the public sector, mainly the ICMR R&D institutes and the remaining 30 percent was contributed by the private pharma sector. Last year, the company also entered the nanotechnology field by producing carbon nanotubes and nanobiochemicals, the only company in India to attain such a feat. Chairman and MD Mr SK Agarwal 32 Business: Manufacturing and process-ing of Molecular Biology Reagents Start-up Year: 1975 Address: Gala No.26, Navketan Indl. Premises, Shanti Nagar, Opp. Onida House, Mahakali Caves Road, Andheri (E), Mumbai-400 093 Tel: +91-22-42685800 Fax: +91-22-42685801 Website: www.srlchem.com Revenue: 15 crore Saksham Technologies Focuses on after-sales support Saksham Technologies clocked revenue worth 14 crore for FY 2010-11 as compared to 10 crore in 2009-10 thereby growing at 40 percent. The company until date, has distribution alliances with Scigenics for their fermentors, process vessels, downstream process equipments; Scanvac for their freeze dryers and speed vaccum concentrators; Esco Micro for their bio-safety cabinets, PCR cabinets, vertical and horizontal laminar air flow cabinets, IVF cabinets and CO2 incubators. Other alliances include Kaltis, Taiwan; Hermle LaborTechnik, Germany; Tuttanauer, Israel; Jeiotech, Korea; Gram Bioline, Denmark; Optika, Italy; and Kern and Sohn GnmbH, Germany. Saksham also signed an MoU with Steris, USA, to promote their products in India. Director Mr Sameer Maheshwari 33 Business: Distribution of refrigeration, clean room equipments, clean air systems and pressure vessels Start-up Year: 1992 Address: 01 - 102,  Sita Nivas,  Plot no 94, RD- 1, Liberty Garden, Malad (West), Mumbai-400 064 Tel: +91-22-40730202, 28893535 / 3636 Fax: +91-22-022-28893636, 28803738 Website: www.saksham.co.in Revenue: 14 crore Trident Equipments Reports flat growth Trident Equipments clocked an annual turnover of 13.50 crore in FY 2010-2011, which is the same as last year. The company is distributors for firms like Thermo Scientific, GEAI, Grant Scientific, Sirus Analytical, Cybio, Analytik JenaKALTIS, Pion and Belloglass. In drug discovery, Trident’s product line includes automated liquid handling platforms, pKa,LoGP and soluility determination and permeability measurement (Pampa) systems; in microbiology it offers air samplers, rapid identification systems; and in electrochemistry it offers pH meters, conductivity, dissoved oxygen and ion meters. The company during the FY, installed around eight to 10 automated platform technologies that have a starting price 18 lakh. During the FY, the company also signed an alliance with Germany-based Analytik JenaKALTIS. And it already has an alliance with UNICEF for its water analysis projects. MD Mr V Kamaraj 34 Business: Supplier of  scientific instruments Start-up Year: 1999 Address: f409/410 Kailas Industrial Complex, Park Site, Vikhroli (W), Mumbai-400079 Tel: +91-22-25181706 Fax: +91-22-25185463 Website: www. tridentequipments.com Revenue: 13.50 crore Esco Biotech Supplies to prestigious R&D centers                     Esco Biotech, is a supplier of  laboratory equipments to the biotech and pharmaceutical sector with emphasis on after-sales service. During the fiscal, it clocked revenue worth 13.10 crore as compared  to 10.70 crore in 2009-2010.  Esco’s product range includes laminar air flow cabinets, biological safety cabinets, CO2 incubators, deep freezers, laboratory fume hoods, hospital pharmacy isolators and modular clean room construction components among others. Biocon, Intas Pharmaceuticals, Piramal Healthcare, Shreya Life Sciences, Advanced Centre For Treatment, Research In Cancer (ACTREC), Serum Institute of India, National Institute For Research In Reproductive Health, Indian Institute of Immunohaematology, National Institute of Oceanography, Gujarat Cancer Research Institute, Central Institute of Cotton Research Center, Bhabha Atomic Research Center and National Center for Antarctic and Ocean Research are some of the clients. Director Mr Sameer Maheshwari 35 Business: Joint Venture with Esco Micro, Singapore Start-up Year: 2005 Address: 01 - 102,  Sita Nivas,  Plot no 94, RD- 1, Liberty Garden, Malad (West), Mumbai-400 064 Tel: +91-22-40730202, 28803636, 32933535 Fax: + 91-22-28803738, 28893636 Website: www.escoglobal.com Revenue: 13.10 crore ]]> <![CDATA[26-30]]> https://biospectrumindia.com/news/95/2242/26-30.html https://biospectrumindia.com/news/95/2242/26-30.html Mon, 11 Jul 2011 12:31:00 +0530 Biogentek BG (INDIA) Looks ahead at a business boost Biogentek has generated revenue of 23 crore during the fiscal 2010-11. The company believes that its association with the companies from the European Union and the US has helped it to grow tremendously. Biogentek has a well defined network of its offices and personnel all over India. Biogentek represents Kuhner AG-Switzerland for shakers and incubator shakers; LEEC Ltd-UK for the Co2 incubators; Nexcelom Biosciences-US for automatic cell counters; Applikon Biotechnology-Holland for bioreactors; CESCO BIO for lab scale and scale up tools. It is among one of the representatives of Labconco Corporation-US for freeze dryers, speedvac concentrators, biological safety cabinets, rotary evaporators, water purification systems, glove boxes, HEPA-filtered controlled atmosphere PCR enclosures. MD Mr Sanjay Gulati 26 Business: Suppliers of cell culture media, consumables and biotech research instruments Start-up Year: 1993 Address: 306, Shah Puri Tirath Singh Tower, C-58, C-Block, Community Centre, Janak Puri, New Delhi-110058 Tel: +91-11-25573125, 25513104 Fax: +91-11-25513106 Website: www.biogentek.com Revenue: 23 crore Skytech Systems Riding on analytical products Skytech Systems is a supplier of process instruments, analytical instruments, calibration standards and kits, test and measure instruments. In the fiscal 2010-11, it clocked sales revenue of 22.5 crore as against 18 crore in 2009-10. The company's key principals include GE Analytical, US for their laboratory, on-line, and portable TOC analyzers; GE Kaye, which is into high accuracy thermal process measurement and Thermo Fisher Scientific, UK for their macro elemental analyzer for simultaneous determination of CHNS/O. Skytech also has an application / testing lab which provides expert support, sample analysis, method validation, and process development for its diverse applications. Regular training for customers is also carried out at customers' sites as well as its application lab. It has a total of six network offices in India. CEO Mr Chandrahas Shetty 27 Business: Supplier of process instruments, analytical instruments, calibration standards & kits, test & measure instruments Start-up Year: 1993 Address: 401, Siddheshwar Arcade, Opp Suraj Water Park, Off Ghodbunder Road, Thane(W) - 400607 Tel: +91-22-41533333 Fax: +91-22-41533344 Website: www.skytechindia.com Revenue: 22.50 crore REMI Elektrotechnik Providing blood banking solutions REMI Elektrotechnik has been a manufacturer and exporter of laboratory and blood banking instruments since 1960. For the fiscal 2010-11, the turnover of the company stood at 22.5 crore as against 17.6 crore in 2009-10, registering a growth of 27.8 percent. REMI products find applications in varied industries like biotech. medical diagnostics, blood banks and hospitals. During the fiscal, the company had undertaken a couple of new initiatives. This included providing complete solutions for the blood banks in India. Through this, the company offers customers with a set of professional services, which include providing turnkey project solutions across India under which an employed team of experts (Medical/Technical) from REMI supports upcoming blood banks with services right from the conceptualization and designing stage to the installation and licensing of these blood bank set ups. CEO (MD) Dr Urmish Chudgar 28 Business: Manufacturer & exporter of laboratory & blood banking instruments Start-up Year: 1960 Address: Remi House, 11, Cama Industrial Estate, Walbhat Road, Goregaon (East), Mumbai Tel: +91-22-40589888 Fax: +91-22-40589890 Website: www.remigroup.com Revenue: 22.50 crore Lonza India Strengthens bioscience base in India Lonza India clocked revenue of 22.20 crore during the fiscal year 2010-11. In India, the company is headquartered in Mumbai and has an R&D Center at Hyderabad. Lonza, which is headquartered in Basel, Switzerland, recorded global sales worth CHF 2.7 billion in 2010. Furthermore, the company has a significant presence in China and Singapore in the Asia Pacific region. The Switzerland-based company is now strengthening its biosciences' base in India, with the construction of its first ever biosciences hub in India at Hyderabad. In an earlier interview with BioSpectrum, Mr Stefan Borgas, CEO, Lonza, Switzerland, mentioned that, â€œThe hub will function as a significant research and production center. The center will be ready by 2012.â€? The company has already established labs in the region. It will hire 120 scientists by 2012, for this high-tech facility. MD and country head Dr Harry S Rathore 29 Business: Pharmaceutical intermediates, cell culture, endotoxin detection products, microbial control actives and formulations Start-up Year: 2007 Address: LBS Marg, Bhandup (West), Corpora, 2nd Floor, Mumbai- 400 078 Tel: + 91-22-43424000, 67257464 / 7465 / 7466 Fax: +91-22-43424050 Website: www. lonza.com Revenue: 22.20 crore Biotron Healthcare Furnishing innovative solutions Biotron Healthcare clocked a total turnover of 21.35 crore in 2010-11 as against 18.50 crore in 2009-10. Since its inception in August 1998, it has built a portfolio of products in its focus areas of drug discovery, liquid handling, genomics and molecular diagnostics. Its product range includes microplate multi-detection systems, liquid handling systems, rapid kit and biosensors manufacturing systems. Product line also includes compound and biological management and storage systems from Matrical, US. The company has till date, marketing alliances with BMG Lab Tech Germany, Cepheid US, PSS Japan, CIS BIO France, Sacace Italy, Quanta UK, Panomics (Affymetrix) US, Biodot US, Ipsogen France, Matrical US. The company is also looking at setting up a local support facility for drug discovery which will house imported equipments from its principals. In the near future, it will also look at introducing products in molecular diagnostics. Director Mr Venkatesh Voleti 30 Business: Drug discovery solutions, liquid handling and turn key solutions for molecular diagnostics Start-up Year: 1984 Address: 301 Coral Classic, 20th road, Chembur, Mumbai 400071 Tel: +91-022-61406400 Fax: +91-022-25281012 Website: www.biotronhealthcare.com Revenue: 21.35 crore ]]> <![CDATA[21-25]]> https://biospectrumindia.com/news/95/2825/21-25.html https://biospectrumindia.com/news/95/2825/21-25.html Mon, 11 Jul 2011 12:28:00 +0530 Nilsan Nishotech Systems Focuses on purification solutions Nilsan Nishotech Systems clocked life sciences revenue of 30 crore for the fiscal 2010-11 as against 20 crore in 2009-10. Nilsan Nishotech focuses on separation technologies by offering customized filtration, separation and purification solutions with technology portfolios of membranes, chromatography and ion exchange to industries. Expertise of the company clearly lies in API/bulk drug manufacturing formulations. Nilsan Nishotech also imparts engineering skills with international technological process made available through its global partner, Novasep Process, part of Groupe Novasep, specializing in developing and promoting cutting-edge technologies such as membranes systems and chromatography. Some of the company's clients in the pharma and biotech sector include Divis, Matrix, Cipla, Torrent and Serum Institute of India. CEO: Mr Sanjay Badani 21 Business: Supplies separation technologies, filtration systems Start-up Year: 1997 Address: W-199-E, MIDC, Thane Belapur Road, Navi Mumbai - 400705. Tel: +91-22-41515151 Fax: +91-22-41515150 Website: www.nishotech.com Revenue: 30 crore 22 Anatek Services Academia, government is its mainstay Anatek Services is a distributor of spectroscopy and chromatography instruments. For fiscal 2010-11, it clocked revenue of 30 crore and reported flat growth. In the previous fiscal (2009-10), the company had clocked the same revenue. Anatek represents companies such as Jasco, Japan and Biologic France. Around 40 percent of its total revenue comes from the life sciences sector. Anatek regularly conducts training programs covering comprehensive course from basic to advance operations and hands on experience on software, routine maintenance and applications on spectroscopy and HPLC. Anatek's main clientele includes universities and pharmacy colleges, pharmaceutical and chemical companies, and government research institutes. Joint MD Mr HG Vadhavkar Business: Providing high quality Analytical Instruments and Technical Services Start-up Year: 1990 Address: 210-214 Sai Chambers, Near Bus Depot, Santacruz (East) Mumbai - 400 055 Tel: +91-22â€“66976816/17, 26671004/0975, 26109608/4285 Fax: +91-22-26104121 Website: www.anatekservices.com Revenue: 30 crore* Premas Biotech Markets genome sequencing tools Premas Biotech offers life science research solutions to companies in India and abroad. Besides being a full fledged contract research and manufacturing services organization, Premas has also been into the marketing of genome sequencing instruments. The company is one of the distributors for the US-based company Illumina which is a market leader in genome sequencing. Registering a good growth in business, the company clocked revenue of 27.70 crore in FY 2010-11 as compared to 23.70 crore in the FY 2009-10. In India, Illumina got its first platform, Bead Array installed at IGIB in 2007. So far, Premas has been instrumental in the installation of over 10 of its flagship genetic analysis platforms. Looking ahead, Premas Biotech, in the current financial year, would further consolidate its distribution business. CEO Dr Rajeev Soni 23 Business: Distributor of genome sequencing tools Start-up Year: 2004 Address: Plot No. 77, Sector 4, IMT Manesar, Gurgaon-122050 Tel: +91-124-4546600 Fax: +91-124-4546624 Website: www.premasbiotech.com Revenue: 27.70 crore* Biodigital Optimistic about future Biodigital has emerged as one of the leading suppliers of equipment in the bioresearch market with prime focus in the field of biotechnology and other related fields. In FY 2010-11, the company reported a decrease in revenue by registering 24 crore as compared to 27 crore in FY 2009-10. Despite this slide, the company is quite optimistic about the good growth opportunities in the current financial year. The brands represented by the company include Syngene, Martin Christ, Dometic, Mennert, Biochrom, Kinematica A G, Marvel Scientific. The company offers products in three market areas, including the life sciences and biotechnology markets, pharmaceuticals, and healthcare. Biodigital has been concentrating on the excellent after sales service to its customers through a team of service engineers. CEO Mr Vijay Bakhru 24 Business: Distributor of life sciences equipments Start-up Year: 2000 Address: 411 Global Foyer, Golf Course Road, Sector-43, Gurgaon, NCR, Haryana-122002 Tel: +91-124-4065283 Fax: +91-124-4147647 Website: www.biodigitalindia.com Revenue: 24.00 crore Pharmalab India Registers 19 percent growth Pharmalab India clocked revenue of 23.60 crore for 2010-11 as against 19.80 crore in 2009-10, registering a growth rate of 19.1 percent. In 2009-10, the company had seen a drop in revenue to 19.80 as against 2008-09 wherein revenue stood at 23.20 crore. In the life sciences space, the company is into the manufacture and supply of process and packaging machines for pharma, biotech and its allied industries. New products launched by the company include the Barrier Isolators brought into India from a Swiss-based company. The company also launched laboratory paper filters, membrane filters and syringe filters. Pharmalab has three manufacturing units in Ahmedabad and one in Mumbai. Some of the products manufactured by Pharmalab include WFI plants, pure steam generators, sterilizers, freeze dryers, liquid packaging machines, filtration systems and consumables. CEO Mr Karnik Parikh 25 Business: Manufacturing and supply of process and packaging machines Start-up Year: 1962 Address: 3rd Floor, Kasturi, Sanghvi Estate, Govandi Station Road, Govandi (East ), Mumbai- 400088 Tel: +91-22-66229900 Fax: +91-22-66229800 Website: www.pharmalab.com Revenue: 23.60 crore ]]> <![CDATA[Rides on innovative after-sales initiatives]]> https://biospectrumindia.com/news/95/1457/rides-on-innovative-after-sales-initiatives.html https://biospectrumindia.com/news/95/1457/rides-on-innovative-after-sales-initiatives.html Mon, 11 Jul 2011 12:26:00 +0530 RANK 19 Revenue 35 Crore Christ Nishotech CEO: Mr Shoeb Kurawadwala Business: Executes turnkey projects in the pharma sector ranging from process water to highly purified water Start-up Year: 1966 Address: Plot No. W-159, MIDC Pawane, TTC Industrial Area, Navi Mumbai-400 705 Tel: +91-22-41579000 Fax: +91-22-27619278 Website: www.christ-nishotech.com In a span of five years, the company has done 150 installations and has rolled out initiatives to provide focused service support to customers Christ Nishotech Water Systems Private Limited (CNWSPL) carries out turn-key projects in the pharmaceutical sector from process water to highly purified water. During the FY 2010-11, the company reported a total turnover of 35 crore as compared to last year’s revenue of 25 crore. In a span of five years, the combined entity in India has done more than 150 installations in India and abroad. Some of the important clients of the company include major pharmaceutical, biotech and healthcare companies such as Wockhardt, Serum Institute of India, Lupin, Dr Reddy’s, Ranbaxy, Cipla, Orchid, Panacea, IPCA, NNE Pharma Plan, Glenmark, Reliance Industries, Biocon, Roche and Pfizer. Christ Nishotech also handled turn-key projects for the Indian units of global biopharma companies like Sandoz, GSK, EISAI, PPIL, Ratio Pharm and Watson. The company has a full-fledged office in Hyderabad and also boasts of an office in Chandigarh. Some of Christ Nishotech’s products include RO, UF, EDI+RO and other water treatment units. The company also rolled out a new initiative called the CN Tech Engineers, which provides services to the company’s customers. CN Tech Engineers has its sub-divisions, which provide focused service support to the clients. CN Care is an annual maintenance contract (AMC) package provided to ensure trouble free operation of the water treatment plant. This includes prevention of breakdowns or output quality deviations. CN Care (CAN Care) is an operation and maintenance package that takes over the task of running the water treatment plan. Intelligence capture  (ICAP) assembles all intelligence captured from the service reports of its service engineers under various operating conditions, analyzes them and uses the intelligence gain to improve the design or suggest corrective operational methodology to eliminate the problem. Some of its alliances include Christ Pharma Life Sciences Group, Switzerland and Inge Water Technology AG, Germany. ]]> <![CDATA[Genaxy rides on molecular biology reagents]]> https://biospectrumindia.com/news/95/4316/genaxy-rides-on-molecular-biology-reagents.html https://biospectrumindia.com/news/95/4316/genaxy-rides-on-molecular-biology-reagents.html Mon, 11 Jul 2011 12:26:00 +0530 RANK 20 Revenue 32.50 Crore Genaxy Scientific CEO: Mr Navneet Trehan Business: Biotechnology research products Start-up Year: 1966 Address: 55-156, C-Block, Community Center, Plot No. 32 to57, Behind Janak Cinema, Janakpuri, New Delhi-110058 Tel: +91-11-47619999 Fax: +91-11-25534163 Website: www.genaxy.com  To strengthen its market share in molbio reagents, the company introduced a complete range of genomic kits from Axygen Biosciences Besides consolidating its existing range of product offerings, Genaxy Scientific is all set to move into proteomics, lab automation and heavy instruments. For the FY 2010-11, the company registered growth of 3.17 percent with revenue of 32.50 crore when compared with 31.50 crore in the previous fiscal. Labnet International was the first company that helped Genaxy establish a foothold in the instrumentation market, followed by a series of tie-ups with instrumentation companies like Nuve, Turkey; Poly Science, US; Scie-Plas, UK and Hoefer, US. The company is also the exclusive distributor of Axygen Scientific, US. In order to strengthen its market share in the molecular biology reagents, the company has now introduced a complete range of genomic kits from Axygen Biosciences including, ambient temperature stable PCR reagents and solutions for 2D electrophoresis from SERVA Electrophoresis, Germany. The company has pitched in with a peculiar product line from qARTA•BIO, US, which provides PCR related research products that are uniquely stable at ambient temperature for almost one month. Genaxy also launched an innovative range of taq polymerase, hot start taq, DNTPs, PCR master mixes and Q PCR master mixes. It has entered the chromatography area, following a tie-up with the US company, Atiji, to market their range of solid phase extraction (SPE) columns in India. Another collaboration was with Flourotechnic, an Australian company specializing in vital fluorescent dyes. In line with its mission to be a one-stop-shop, It entered into molecular biology reagents through its collaboration with Serva, Germany. The specialty of these products is that they can be customized according to the scientists’ needs. The company has also ventured into the blood banking (healthcare) area by associating with many big hospitals in India. Genaxy is launching its own low cost-range of electrophoresis equipments to target colleges. ]]> <![CDATA[Leads in microbio culture media production]]> https://biospectrumindia.com/news/95/2821/leads-in-microbio-culture-media-production.html https://biospectrumindia.com/news/95/2821/leads-in-microbio-culture-media-production.html Mon, 11 Jul 2011 12:24:00 +0530 RANK 18 Revenue 56.25 Crore HiMedia  Laboratories CEO: Dr GM Warke Business: Manufacturer of media products for microbiology,  immunology and serology Start-up Year: 1976 Address: A-406, Bhaveshwar Plaza, LBS Marg, Mumbai-400 086 Tel: +91-22-25003747 / 1607 / 0653 Fax: +91-022-25005764 / 2468 Website: www.himedialabs.com HiMedia is showing continuous growth in the reagents sector and this has helped it reach revenue worth `56.25 crore in this fiscal HiMedia Laboratories is considered to be amongst the few companies in India to possess high-technology know-how for manufacturing of microbiological culture media. During the fiscal year 2010-11, the company clocked an estimated biotech revenue of `56.25 crore when compared with `45 crore in the previous year. HiMedia produces HiVeg Peptones (hydrolysates prepared from non-animal sources, such as wheat, corn and soy), which are manufactured by its sister company, Warkem Biotech. The manufacturing plant had recently been overhauled in order to meet global needs, particularly with the increasing demand for non-animal protein hydrolysates. This apart, the company launched comprehensive and easy-to-perform kits for soil and water analysis for farmers and agriculturists. The company also launched kits for testing adulteration in milk and detection of arsenic in water, a  kit to detect mastitis in cows (in collaboration with Shree Chitra Tirunal Institute, Kerala) and cost-effective kits for detection of sickle cell anemia (screening as well as confirmation). HiMedia also made an entry into the stem cell and primary cell markets wherein cells and media are made available to scientists at an affordable cost. Scaling up of production of stem cells, primary cells and their media is on the cards. Presently these are being imported and by 2011 the company is looking  to make these available in India. HiMedia is a partner in supplying culture media to the National Biodiversity Screening Program, which was introduced two years ago by the Department of Biotechnology, to screen the rich and diverse flora and fauna in India. During the outbreak of the H1N1 pandemic, HiMedia launched the  swine flu transport kit. These kits were manufactured at the company’s Nasik facility. For this particular kit, the company acquired six new biosafety level type 2 cabinets, and bought appropriate filtration equipments. ]]> <![CDATA[Continues to be a leader in membranes]]> https://biospectrumindia.com/news/95/2330/continues-to-be-a-leader-in-membranes.html https://biospectrumindia.com/news/95/2330/continues-to-be-a-leader-in-membranes.html Mon, 11 Jul 2011 12:23:00 +0530 RANK 16 Revenue 84.17 Crore Advanced Microdevices MD: Mr Nalini Kant Gupta Business: Production of microporous membranes and separation products Start-up Year: 1976 Address: No.20-21, Industrial Area, Ambala Cantonment, Haryana-33006 Tel: +91-171-2699290/471 Fax: +91-171-2699221/008 Website: www.mdimembrane.com A new 85,000 sq ft state-of-the-art GMP facility has been set up recently by the company at a cost of over 20 crore Advanced Microdevices (MDI) registered a growth of over 21 percent in 2010-11 with an estimated revenue of 68 crore in 2010-11 as compared to 56 crore in 2009-10. A new 85,000 sq ft state-of-the-art GMP facility has been set up recently by the company at a cost of over 20 crore. This facility includes a 10,000 sq ft Class 10,000 (ISO 7) clean production area. It also houses a 9,000 sq ft well equipped filter validation lab with all the necessary instruments that are required to deal with modern day drug formulations, novel drug delivery systems (NDDS), oncology drugs and therapeutic recombinant proteins. Products are exported to more than 50 countries worldwide, including US, Western Europe, China and South Korea. The company has deep penetration in the India biopharmaceutical industry and enjoys dominant position in many product segments. An overseas office has recently been set up in California, US and work is on for setting up a new joint venture company in the US. Advanced Microdevices included nucleic acid isolation, purification, and separation kits in its product range. The company also produces very consistent nitrocellulose membranes for rapid immunodiagnostic tests, whose quality is world renowned. MDI is the global leader in these membranes. The MDI red blood cells (RBC) separator for lateral flow tests is the best in the market in terms of efficacy and efficiency. A unique rapid plasma separation device has been developed for use with quantitative diagnostic analyzers and point of care applications (patent pending). The focus at MDI is on using its membrane technologies as a platform for developing new value added products for use in filtration and separation. MDI product portfolio boasts of more 15,000 products, manufactured in an ISO 9001:2008 certified production facility and are CE certified. A Drug Master File for the filtration products was submitted to the USFDA in the year 2002. ]]> <![CDATA[Toshwin grows customer base by 40 percent]]> https://biospectrumindia.com/news/95/6736/toshwin-grows-customer-base-by-40-percent.html https://biospectrumindia.com/news/95/6736/toshwin-grows-customer-base-by-40-percent.html Mon, 11 Jul 2011 12:18:00 +0530 RANK 14 Revenue 89.70 Crore Toshwin Analytical MD: Mr Nakul Toshniwal Business: Specializes in analytical and laboratory equipment for life sciences Start-up Year: 1948 Address: 103, SJ House, 1st Floor, Sitaram Mills Compound,  NM Joshi Marg, Lower Prael , Mumbai - 400011 Tel: +91-22-23015096 Fax: +91- 22-23013592 Website: www.toshvin.com Toshwin has over 40 years of partnership with Shimadzu and is leveraging on its experience to grow its customer base significantly Toshwin Analytical clocked revenues worth `89.7 crore in 2010-11 when compared with `85.1 crore in 2009-10.  This represented a growth rate of 5.4 percent over the previous fiscal. The company is a distributor for three major overseas companies and operates  in the field of analytical and laboratory equipment in the life sciences industry. Toshvin Analytical has over 41 years of partnership with Shimadzu Corporation, Japan. Since its inception, the company operated with the help of three distinct divisions including, analytical instruments, water purification and accessories and consumables. Toshvin represents TKA, Germany, for their complete range of water purification systems. In the analytical instrumentation domain, Toshvin represents Shimadzu in India for a wide range of products like UV-Vis, FTIR and AA spectrophotometers, single drop UV-Vis spectrophotometer, gas chromatographs (GC) and GC-mass spectrometers (GCMS), thermal analyzers, spectrofluorophotomers, particle size analyzers and ICP spectrometers. In addition to the partnership with Shimadzu, Toshvin also represents Restek Corporation, US, for chromatography columns and accessories. Until last year, the company developed an installation base of 10,000 of Shimadzu’s instruments and has a  customer base of over 7,000 clients, which is a considerable increase from 5,000 clients in 2009-10. Some of the major clients of Toshwin include companies in the pharmaceutical and life sciences industry, including both Indian firms and MNCs, leading research institutes and most of the premier universities. Toshvin operates through a network of 12 offices in order to provide effective and efficient marketing and service support to its customers all over the country. As of last year, the total headcount in the company was 156 people. Application support to customers is provided through close cooperation with Shimadzu India’s customer support centers located in Mumbai and Delhi respectively. ]]> <![CDATA[Rides on speedy liquid handling processes]]> https://biospectrumindia.com/news/95/2350/rides-on-speedy-liquid-handling-processes.html https://biospectrumindia.com/news/95/2350/rides-on-speedy-liquid-handling-processes.html Mon, 11 Jul 2011 12:17:00 +0530 RANK 13 Revenue 90.80 Crore Eppendorf India CEO: Mr V Sankarnarayanan Business: Develops, produces and distributes systems for use in laboratories Start-up Year: 2003 Address: Doshi Towers, 4th Floor, 156, Poonamallee High Road, Kilpauk, Chennai – 600010 Tel: +91-044–42111314, 1341 Fax: +91-044 – 42187405 Website: www.eppendorf.co.in Eppendorf showcased an increase in revenue in 2010-11 due to synergy between the products from both Eppendorf and New Brunswick Eppendorf India is the Indian arm of Eppendorf AG, Germany. Eppendorf India develops, produces and distributes systems for use in life science research laboratories worldwide. The company recorded revenue of 90.8 crore in 2010-11 as against 73.63 crore in 2009-10 thus registering a growth of 23.32 percent over last year. Eppendorf India show-ed good increase in revenue in 2010-11 due to the synergy between the products from both Eppendorf and New Brunswick. Acquisition of New Brunswick by Eppendorf helped Eppendorf India to increase the sales significantly. During the year, Eppendorf launched Eppendorf Xplorer (electronic pipette), Eppendorf Eporator (electroporator), epBlue ID, twin.tec PCR plates (unskirted), PCR plates (divisible), three new rotors for Centrifuges 5804/R and 5810/R. New Brunswick also introduced High Efficiency -86°C Freezers, Galaxy 170R CO2 incubators (refresher versions). Eppendorf products are grouped in three competence areas — liquid handling, sample handling and cell handling. Eppendorf products are aimed at academic and commercial research institutes as well as companies from pharmaceutical and diagnostics industries. Eppendorf’s liquid handling products range from manual pipettes to electronic pipettes, dispensers, and burettes to automated pipetting systems. Eppendorf pipette tip and combitip range comprises a wide variety of standards for certified purity and makes a major contribution to user-friendly liquid handling in the laboratory. In the area of sample handling, Eppendorf’s range includes devices for centrifugation, heating, freezing, mixing, amplification and photometry. A further important product group is consumables for sample handling. The best-known consumable is the Eppendorf tube, fondly referred to as “Eppi” by users worldwide. In addition, the company offers reaction plates, disposable cuvettes, and consumables for PCR. ]]> <![CDATA[Consolidates position by boosting infrastructure]]> https://biospectrumindia.com/news/95/7221/consolidates-position-by-boosting-infrastructure.html https://biospectrumindia.com/news/95/7221/consolidates-position-by-boosting-infrastructure.html Mon, 11 Jul 2011 12:16:00 +0530 RANK 12 Revenue 96.52 Crore Genetix Biotech Asia CEO: Mr Arun Prakash Business: Technical support and distribution of life sciences supplies Start-up Year: 1991 Address: 71/1, Shivaji Marg, New Delhi-110015 Tel: +91-11-41427031 Fax: +91-11-25419631 Website: www.genetixbiotech.com Genetix seeks to consolidate its position in manufacturing of new products and aims to emerge as a strong distribution firm Genetix Biotech Asia is not only the distributor of major life sciences’  brands but is also the manufacturer of many laboratory research products. By implementation of correct strategies and innovation, the company has been able to double its revenue during the last five years. In FY 2010-11, the company registered growth and touched a revenue of 96.52 crore as compared to 90 crore in the previous fiscal. Genetix represents market leaders in the life sciences industry including, Stratagene, HyClone, Qiagen, Nalgene and Nunc among several other firms. In 2010, Genetix put up a state-of-the-art clean room facility for moulding laboratory plastics in a special economic zone, 250 km North of New Delhi. The company is investing heavily into the further expansion of  R&D for the development of a number of new products, and is also conducting validation and trouble shooting for products that are being imported. During 2010, the indigenously manufactured, thermal cycler, CG Palm Cycler, exceeded the quality control parameters and has been well received by its customers. To further improve the customer relations, Genetix installed SAP, which is customized to provide faster and more efficient service to its customers. In 2009, Genetix acquired the business of thermal cyclers from Corbett Research, Australia, and moved its production down to India. This is an ISO 9000 and TUV certified facility for manufacturing ‘Palm Cyclers’ PCR machines that would be distributed to India and 30 other countries. Mr Arun Prakash, CEO, Genetix Biotech Asia, while talking about the future strategy, said, “Genetix is committed to enhancing its image as the most preferred supplier of consumables and instruments to the biotech research and vaccine production market segment. Besides that, we are aiming to cover around 50 percent of the business revenue from our own brand CELLclone.” Banking on the technical collaborations, the company is optimistic that it will exceed sales of 110 crore in the current financial year. ]]> <![CDATA[RFCL benefits from the aquisition by Avantor]]> https://biospectrumindia.com/news/95/3296/rfcl-benefits-from-the-aquisition-by-avantor.html https://biospectrumindia.com/news/95/3296/rfcl-benefits-from-the-aquisition-by-avantor.html Mon, 11 Jul 2011 12:00:00 +0530 RANK 11 Revenue 106.70 Crore RFCL MD: Mr Sushil Mehta Business: Manufacturing and marketing of fine chemicals and lab kits Start-up Year: 2005 Address: A-3, Okhla Industrial area, Phase-I, New Delhi-110020 Tel: +91-11-41609171 / 75 Fax: +91-11-41609189 Website: www.rfcl.in  RFCL, which has been acquired by US-based Avantor, is expected to leverage the experience of its new mentor to improve its products RFCL, formerly known as Ranbaxy Fine Chemicals Limited, is a maker of laboratory reagents, consumables and products for the medical diagnostics’ market. The company is now a part of US-based Avantor Performance Materials Holdings, which is involved in manufacturing and marketing high-performance chemicals and materials. The acquisition took place following the exit of the previous owner, ICICI  Venture Funds Management Company. Avantor can use the RFCL’s network in India to push its products in the market. During the FY 2010-11, the company recorded revenue worth 106.7 crore as compared to 93.23 crore in FY 2009-10. The company is managed by a group of professionals and it focuses primarily on two strategic business units – Rankem Scientific Laboratory Solutions and Diagnova. The two business segments cover a range of customer segments including pharmaceuticals, biotechnology, R&D laboratories, food processing, in vitro diagnostic facilities in clinical labs, hospitals and nursing homes. Together, the two business units constitute a business group of approximately 2,400 million. Driven by its vision, ‘Leveraging Science to Provide Solutions for a Better Life’, RFCL is aggressively building both its businesses backed by R&D, product development and manufacturing, to offer value added products and services to its target customers. The company in 2010 unveiled its new mid-term plan called ‘SPRINT 2014’, which it expects to enable RFCL to grow at a CAGR of  almost 23 percent in the next four years. RFCL added 64 products to its portfolio. In molecular biology, an additional 47 products will be completing the basket of fermentation area where the purity and accuracy is now defined at upstream process. In July 2010, RFCL inked a technology transfer partnership with Diagon, Hungary, for Haematology reagents. Also, a new lab chemical manufacturing plant of the company is coming up at Panoli, Gujarat. ]]> <![CDATA[Aims to be a complete solution provider]]> https://biospectrumindia.com/news/95/1799/aims-to-be-a-complete-solution-provider.html https://biospectrumindia.com/news/95/1799/aims-to-be-a-complete-solution-provider.html Mon, 11 Jul 2011 11:59:00 +0530 RANK 10 Revenue 116.84 Crore DSS Imagetech MD&CEO: Mr Arvinder Dhingra Business: Suppliers of clinical lab, biotech research instruments and tools Start-up Year: 1965 Address: A-5 Mohan Cooperative Industrial Area, New Delhi-110044 Tel: +91-11-30886763 Fax: +91-11-41678694 Website: www.dssimage.com DSS Imagetech expanded its product range significantly and reshaped its business by entering into a JV with Takara Bio,Japan DSS Imagetech provides cutting-edge technology solutions to researchers working in different areas of biotechnology. After an initial focus on microscopy, the company gradually expanded its product range and included application areas such as image analysis software systems, genetic workstation, DNA probes and microarray readers. The company has now entered into the manufacturing of high-end molecular biology reagents. In the FY 2010-11, the company registered a good growth rate with revenue touching to 116.84 crore as compared to 88.08 crore in the FY 2009-10. On April 1, 2011, DSS Life Sciences, a division of DSS Imagetech  entered into a joint venture with the Japanese company Takara Bio and formed a new company known as DSS Takara Bio India. The joint venture is eying the opportunities arising out of increased research funding and the lack of manufacturing units in the country. According to Dr Ushakar Nag, director, DSS Takara Bio India, “The JV is a milestone achievement for DSS and will take the company to a new dimension. It will bring the manufacturing technology of high end molecular biology reagents to India, thereby giving a competitive edge to Indian biological resea-rch. We plan to offer the diagnostic kits at a never-seen-before lowest price in India. I hope that this JV will be able to fill the void with a focus on kits.” Micro-Imaging division being the oldest division of DSS is the backbone of the company. DSS enjoys a unique position as the most informed supplier of microscopes and digital imaging solutions in the country. DSS continues to provide training in the field of IHC, FISH and advanced imaging through its training division. To tap the rapidly growing medical and surgical market in India, DSS recently set up its Medical Division and tied up with Olympus Medical Systems for their flexible gastroenterology and bronchoscopy products for North and East India. ]]> <![CDATA[Plans to implement localized strategies]]> https://biospectrumindia.com/news/95/7648/plans-to-implement-localized-strategies.html https://biospectrumindia.com/news/95/7648/plans-to-implement-localized-strategies.html Mon, 11 Jul 2011 11:57:00 +0530 RANK 9 Revenue 123 Crore Sigma-Aldrich Chemicals CEO: Mr Raja Ram Business: Manufacturer and supplier of chemicals, biochemicals and equipment Start-up Year: 1991 Address: Plot #12, Bommasandra Jigani Link Road, Bangalore - 560 100 Tel: +91-80-66219400 Fax: +91-80-66219450 Website: www.sigmaaldrich.com/ india Sigma-Aldrich’s closely inter-related units have earned a reputation for quality and performance Sigma-Aldrich Corporation’s chemical products and kits are used in scientific research, including genomic and proteomic research, biotechnology, pharmaceutical development and as key components in pharmaceutical, diagnostic and other high technology manufacturing. It has customers in life science companies, university and government institutions, hospitals and in the industry. In the life science area, it provides  a range of products for molecular biology, protein expression and proteomics, cell biology, functional genomics and transgenics.  Sigma-Aldrich witnessed a 23 percent growth in India in life sciences space. According to BioSpectrum the life sciences revenue of Sigma-Aldrich is estimated at 123 crore in 2010-11 against previous year’s estimated life sciences revenue of 100 crore. Sigma Life Science, a Sigma-Aldrich  brand, had the global release of a pioneering range of engineered mammalian cell lines in September 2010. This new product range combines Sigma’s proprietary CompoZr zinc finger nuclease (ZFN) technology with its extensive experience in gene silencing, to offer innovative tools for drug discovery, compound screening and fundamental research applications. During early 2011, Sigma added new modified cancer cells to it’s range of high-quality cell lines. These human knockout and knock-in oncology cell lines, created using Sigma’s proprietary ZFN technology, offer researchers cellular models of cancer that are expected to enhance development of drugs for personalized medicine. The company has four business units Essentials, Specialties Research and Biotech Research and the Fine Chemicals Unit, SAFC. Globally, the company operates in 40 countries, manufacturing 48,000 of the 130,000 chemical products it offers. The company also offers 40,000 equipment products and sells it in over 160 countries, servicing over 92,000 accounts, which represents over one million individual customers. ]]> <![CDATA[Explores next generation sequencing market]]> https://biospectrumindia.com/news/95/1805/explores-next-generation-sequencing-market.html https://biospectrumindia.com/news/95/1805/explores-next-generation-sequencing-market.html Mon, 11 Jul 2011 11:56:00 +0530 RANK 8 Revenue 135.10 Imperial Life Sciences CEO: Mr Suresh Kumar Gupta Business: Supplier of products used in biotechnology and molecular biology research Start-up Year: 1992 Address: Plot No. 463, Sector 37-II, Pace City II, Gurgaon-122001 Tel: +91-124-4559800 / 99 Fax: +91-124-4559801 Website: www.imperialls.com The major business drivers were microarrays, automated electrophoresis units, flow cytometers and imaging flow cytometers Imperial Life Sciences (ILS) has been able to maintain a consistent growth rate of 19.7  percent this year too. The company registered revenue of 135.10 crore in the FY 2010-11 as against 112.85 crore in the last fiscal. In continuation with last year’s trend, 70 percent of the revenue has been generated from the instrumentation business and the rest 30 percent from the reagents business. ILS has been an exclusive representative of many leading global players in India. The company provides complete solutions in instrumentation, reagents, bioinformatics and consumables. Besides that it has the entire range of products for labs working in genomics, proteomics, cell culture, drug discovery and bioproduction. The company has collaborated with many key players from different segments of the business like Affymetrix, a market leader in microarrays; NEB, a key player in restriction enzymes; Miltenyi Biotech, a market leader in magnetic cell separations and Biometra which provides thermal cyclers. With a strong focus on existing and emerging markets, ILS has expanded its focus on genomics and cell biology instrumentation and consumables. Now it is exploring the possibilities of expanding into the Next Generation sequencing market in collaboration with existing and new principal partners. According to Mr Neeraj Gupta, director, Sales and Marketing, “The major business drivers this year were microarrays, automated electrophoresis units, flow cytometers, imaging flow cytometers and in vivo imaging systems with multiple units sold throughout the country.” The ILS has also started Custom Bonded Warehouse for the long term benefit of its customers. Talking about this focus of the company, Mr Suresh Kumar Gupta, CEO, ILS, says, “With the availability of a Warehouse, the customers can purchase products in Indian currency with same custom duty benefit pricing and faster deliveries across India. This has helped the company to simplify delivery and ordering process.” ]]> <![CDATA[Rides high on weighing, automation technology]]> https://biospectrumindia.com/news/95/7255/rides-high-on-weighing-automation-technology.html https://biospectrumindia.com/news/95/7255/rides-high-on-weighing-automation-technology.html Mon, 11 Jul 2011 11:55:00 +0530 RANK 7 Revenue 166.05* Sartorius Stedim India Managing Director: Mr Amit Chatterjee Business: Analytical and Scientific Instrumentation Start-up Year: 1991 Address: No 69/2 & 69/3, Jakkasandra, Kunigal Rd, Nelamangala Taluk, Bangalore - 562123, Tel: +91-80-43505250 Fax: +91-80-43505255 Website: www.sartorius.com About 90 percent of the sales of Sartorius Stedim India comes from domestic business while the rest from the exports Sartorius Stedim India is a part of the Sartorius Group, a global laboratory and process technology provider covering the segments of biotechnology and mechatronics. The company reported a sales revenue of 166.05 crore from its life sciences business in 2010-11 as against 145 crore in 2009-10. About 90 percent of the sales of Sartorius Stedim India comes from domestic business while the rest from the exports. Through its presence in India, Sartorius brings the expertise of Sartorius group to its Indian customers apart from adding value through quality manufacturing of engineered systems in biotechnology and mechatronics. In June 2010, Sartorius Stedim Biotech, launched Sartoflow Alpha plus SU — a new system that combines highest cross flow filtration performance and single-use technology. The easy-to-use system delivers full operational flexibility and is optimized for ultrafiltration, microfiltration and diafiltration applications used in many downstream processes like purification of vaccines, monoclonal antibodies or recombinant proteins. In 2010, it expanded its array of ultrafilters with the Sartocon ECO series of ultrafilters, which have been developed for biotechnological and pharmaceutical purification processes in the industry for the manufacture of vaccines and monoclonal antibodies. In March 2011, Sartorius Stedim Biotech, expanded its portfolio for quality assurance in the lab by launching Microsart @vance, which has been specifically designed for microbiological quality control in the pharma and biopharma industries. Among other products, Sartorius in Bangalore, develops and manufactures bioreactors and additional equipment for pharmaceutical customers, lab equipment as well scales and other weighing equipment for industrial applications. It exports its products and components to Group companies in Germany and other Asian countries. ]]> <![CDATA[Leveraging on biotech consumables, reagents]]> https://biospectrumindia.com/news/95/2515/leveraging-on-biotech-consumables-reagents.html https://biospectrumindia.com/news/95/2515/leveraging-on-biotech-consumables-reagents.html Mon, 11 Jul 2011 11:52:00 +0530 RANK 6 Revenue 180 crore* Invitrogen Bioservices India MD: Mr Devashish Ohri Business: Manufacturer and supplier of biotech consumables and instruments Start-up Year: 2005 Address: First Technology Place, 3 EPIP, Whitefield, Bangalore - 560066 Tel: +91-80-41785400 Fax: +91-80-41680430 Website: www.invitrogen.com Having acquired the Applied Biosystem agency business from LabIndia Instruments, Invitrogen has better access to a robust line of products Life Technologies Corporation, headquartered in California, US, operates in India as Invitrogen Bioservices India, specializing in biotech consumables and benchtop instruments. Invitrogen India commenced operations in 2005 from Bangalore. Having acquired the Applied Biosystems agency business from LabIndia Instruments, Invitrogen has better access to a robust line of products that provide end-to-end solutions, as well as customer and technical service support. Invitrogen BioServices offers its products and solutions through three key functional divisions: Co-located state-of-the-art facility housing commercial, research and support functions, technology driven R&D and manufacturing operations, and global customer service division. According to BioSpectrum estimates, company has clocked life sciences sales revenue of 180 crore in 2010-11 as against 140 crore in 2009-10 from its India operations. In September 2010, Life Technologies signed cell line license agreements with a number of companies from across the world including Indian Immunologicals of Hyderabad to provide rights to its proprietary CHO (Chinese hamster ovary) cell lines for the production of recombinant proteins used as therapeutic agents and vaccines. In August 2010, Life Technologies launched its Applied Biosystems 3500 Dx Series Genetic Analyzers, the first CE IVD-marked capillary electrophoresis system for nucleic acid analysis, across Asia Pacific including India. Mr Devashish Ohri, managing director, Life Technologies South Asia says, “Invitrogen consumables along with Applied Biosystems instruments provide a wide spectrum of solutions to meet customer needs and align with their growth strategy. The next wave of growth will now come in applied markets relating to biofuels, diagnostics, forensics, agriculture, which according to ABLE could be 25 percent of the total biotech market size.” ]]> <![CDATA[Sets sight on mass spectrometer products]]> https://biospectrumindia.com/news/95/2037/sets-sight-on-mass-spectrometer-products.html https://biospectrumindia.com/news/95/2037/sets-sight-on-mass-spectrometer-products.html Mon, 11 Jul 2011 11:49:00 +0530 RANK 5 Revenue 186 crore* Shimadzu Analytical (India) MD: Mr Senya Imamichi Business: Analytical and Scientific Instrumentation Start-up Year: 2006 Address: 1A/B Rushabh Chambers, Makwana Road, Marol, Andheri (East), Mumbai â€“ 400059 Tel: +91-22-29204741 Fax: +91-22-29201678 Website: www.shimadzu.com Life sciences, with 70 percent revenue share, continues to be a major contributor to Shimadzu Analytical's (India) overall revenue Shimadzu Analytical (India), a subsidiary of Shimadzu Corporation, focuses on offering technologies in the field of analytical and scientific instrumentation, process control instrumentation, and environmental monitoring. For fiscal 2010-11, the company clocked revenue of 186 crore as against 141 crore in 2009-10. The growth has primarily been due to the recovery of the India life sciences market after May 2010. The Indian subsidiary completed five years of direct operations in India in April 2011. Started in 2006, in India, Shimadzu presently has five marketing partners namely Spinco Biotech, Toshvin Analytical, Swan Environmental, Saksham Analytical Instruments and Amkette Analytics. Shimadzu has been operating in the India life sciences space for the past 40 years through these distributors. Life sciences, with 70 percent revenue share, continues to be a major contributor to the subsidiary's overall revenue. Over the past one year, the pharma companies, have been making considerable investments in high-end research activities. This is due to the gradual shift of India from a drug development to a drug discovery destination. This in turn has had a positive affect on Shimadzu India's overall life sciences revenue. â€œIndian companies are now looking at NCE research, which requires high-end technology. Moreover, many pharma companies are particular about quality control. This has proved to be an advantage for Shimadzu India,â€? says Mr Senya Imamichi, managing director, Shimadzu Analytical (India). In the coming years, Shimadzu India will focus on its mass spectrometer product, as pharma companies are stepping-up focus on high-end NCE research. The company has also invested in expansion of its infrastructure, customer service and training activities. Says Mr Imamichi, â€œSince 2006, we have doubled our infrastructure space and also doubled investments in customer services.â€? ]]> <![CDATA[The fastest growing Waters subsidiary]]> https://biospectrumindia.com/news/95/1212/the-fastest-growing-waters-subsidiary.html https://biospectrumindia.com/news/95/1212/the-fastest-growing-waters-subsidiary.html Mon, 11 Jul 2011 11:44:00 +0530 RANK 2 Revenue 456.58 Waters India President: Mr K V Venugopalan Business: Manufacturer and supplier of analytical instruments and solutions Start-up Year: 1988 Address: 36A, II Phase, Peenya Industrial Area, Bangalore- 560058 Tel: +91-80-28371900-04 Fax: +91-80-28392157 Website: www.waters.com Riding on complementary analytical technologies, Waters India is also one of the largest analytical companies in India Waters India, a subsidiary of Waters Corp., headquartered in Massachusetts, holds worldwide leading position in complementary analytical technologies — liquid chromatography, mass spectrometry, rheometry and microcalorimetry. Waters designs, manufactures, sells and services UPLC, HPLC, chromatography columns and chemistry products, mass spectrometry systems, thermal analysis and rheometry instruments. Bangalore-based Waters India has recorded revenue of 362.52 crore in 2010, registering a significant growth of 38.26 percent over last year’s revenue of  262.2 crore. Large chunk of this came from the sale of mass spectrometers and liquid chromatography systems. This achievement and growth can be attributed to Waters network across the country and a strong base of 15 stockists. Waters India has achieved the rare distinction of being one of the fastest growing Waters subsidiaries in the world and has become one of the largest analytical companies in India. During the year, Waters introduced new Acquity UPLC and HPLC columns that offer scientists additional selectivity choices and improved chromatographic performance for separations using acidic, low ionic strength mobile phases. It also introduced the first-of-its-kind Waters Acquity UPLC H-Class Bio System, expanding the scientific and business benefits of UPLC technology for macromolecule analysis. Besides, Waters introduced the new Ostro Sample Preparation Plate, representing a novel approach for the removal of phospholipids from biological samples. While Waters offers a broad array of technologies, it still maintains platform products in four key areas: instruments, chemistries, software, and services. Sharing his thoughts on the achievement of the company, Mr K V Venugopalan, president, Waters India, says, “A 40 percent growth during the year proves that the measures that we have taken during the economic slowdown in 2009 have yielded excellent results not only in increasing employee morale and loyalty but also our business.” ]]> <![CDATA[Registers a whopping growth of 82 percent]]> https://biospectrumindia.com/news/95/2631/registers-a-whopping-growth-of-82-percent.html https://biospectrumindia.com/news/95/2631/registers-a-whopping-growth-of-82-percent.html Mon, 11 Jul 2011 11:41:00 +0530 RANK 1 Revenue 456.58 Spinco Biotech MD: Mr C Ravindranath Business: Distribution of analytical instruments Start-up Year: 1981 Address: PB No. 6114, No. 4 Vaidyaram Street, T Nagar, Chennai- 600017 Tel: +91-44-24340174, 24337479 Fax: +91-44-24340761 Website: www.spincotech.com Spinco Biotech's tremendous growth is attributed to the growth in laboratory and chromatography equipments The company has registered a significant growth of 82 percent in 2010-11 as sales revenue touched 456.58 crore as compared to last year's revenue of 250.68 crore. This tremendous growth is attributed to the growth in laboratory equipments (122 crore from 10 crore) and chromatography equipments (277 crore from 195 crore). In January 2011, Spinco Biotech entered into partnership with Illumina, a global leader in next generation sequencing and array-based solutions. During the same month, Spinco Biotech along with LCGC launched First Source Laboratory Solutions as a one-stop source for a wide range of laboratory equipments. The products range from pipettes to freeze dryers from global leaders such as SP Scientific, Reichert, Corning, Kinematica, Proton, MMM, Major Science, Select Bio Products, IKA, to name a few. Spinco's commitment towards customer education has resulted in the inception of IICMS (Indian Institute of Chromatography and Mass Spectrometry) at Chennai in January 2011. This provides world class formal training in advanced use of HPLCs and MS systems. Spinco group is also diversifying into contract research services and reagent manufacturing through Perfomics Biolabs initiative. The year 2010 has reiterated Spinco Biotech's market leadership in chromatography with an installed base of over 12,000 Shimadzu HPLCs in India. This has paved the way for expansion of its portfolio into the mass spectrometry arena, introducing advanced MS platforms from Shimadzu. In August 2010, Spinco reached its greatest milestone of 10,000 Shimadzu HPLCs installations in India. Through its Lyo, Lab and Process solutions, Spinco brings automation to process technologies such as PAT/NIR online analyzers (FOSS, US), pilot and production homogenizers (Kinematica AG, Switzerland), automatic loading/unloading vial transfer carts coupled with large-scale production lyophilizers (SP Industries - VirTis/FTS/Hull, US) and lab gas generators (Peak, UK). ]]> <![CDATA[Risk-averse society to stunt biotech growth]]> https://biospectrumindia.com/news/95/7337/risk-averse-society-to-stunt-biotech-growth.html https://biospectrumindia.com/news/95/7337/risk-averse-society-to-stunt-biotech-growth.html Mon, 11 Jul 2011 11:19:00 +0530 More biotech drugs than conventional products are getting approved in many nations than a decade ago. This does not however mean that the biotechnology industry will be on a roll in the coming decades. Some recent regulatory decisions against some promising products indicate that it will not be a rosy path for some time to come. As I write this editorial from Washington DC while attending the annual Bio International Conference, came a devastating news. A panel of experts appointed by the US regulator, the Food and Drugs Administration (FDA), has recommended against the use of the world's largest selling biotech drug, Avastin, in treating breast cancer. Reluctantly approved in 2008 as a promising cure against breast cancer, Genentech's Avastin had zoomed to the top of the biotech sales chart quickly to garner global revenues of $6.8 billion. The healthcare community and patient groups have been raging against each other over the efficacy of this drug which costs over $88,000 for a year's treatment. The regulator decided to withdraw the drug in December but agreed to a wider review by experts. With the experts voting against the use of Avastin in the treatment of breast cancer, the FDA chief will have very little option but to implement the recommendation. Of course, this does not mean the end of the road for Avastin which has been approved in the treatment of other types of cancers in combination with different sets of drugs. What about the fate of 17,500 women in the US and an equal number in other countries who had found some hope in Avastin treatment in the last two years? Most of them along with their families have made the informed choice to get Avastin treatment despite the enormous costs involved. Should these patients be denied the few extra months of life which the drug has given because of the fear of other side-effects. It is easy to blame regulators. But regulators are not part of the problem. Biotech scientists are near unanimous that the regulators are only responding to the signals from the society which has become increasingly risk averse. Progress in science happens in stages and acceptable risks are part of the drug development process. But even as people revel in the marvels of modern science, risk aversion in every walk of modern life is percolating to healthcare too. The evidence of this comes from other parts of the world too. Cucumbers have disappeared from kitchen all over Europe after the e.coli outbreak was traced to a batch of organic Spanish cucumbers. This is not the first outbreak linked to organic products. On the other hand, genetically modified (GM) food products are scientifically proven to be safer than organic products. Yet the advances of GM technologies are restricted to just a handful of nations. India's reluctance to allow the consumption of its first GM food, a transgenic brinjal variety, is an example of the risk aversion philosophy triumphing over science. In the US too, a politically motivated move has slowed the approval process of the world's first transgenic animal food, the GM salmon which could supplant the protein supply caused by the large scale depletion of natural salmon due to over fishing and environmental causes. Biotech industry leaders have some more work to do outside their R&D centers to win public support for their work. The industry has not done a good job of this so far. After the ranking of India's Top 20 biotech companies, it is time to do the same for key technology enablers who are an integral part of the biotechnology industry. The BioSuppliers industry has registered a 19 percent growth over the previous year's single-digit growth numbers. This segment with revenues of 4,600 or $1 billion is an indicator of the status of the core biotech industry. Some credit should also go to companies like Spinco Biotech which has zoomed to the No.1 rank with an amazing growth of 80 percent. The vibrant tech enablers community is an integral part of the biotech ecosystem and their significant contribution is a booster for the industry. Narayanan Suresh Chief Editor sureshn@cybermedia.co.in ]]> <![CDATA[Vaccines approvals increase in India]]> https://biospectrumindia.com/news/95/5959/vaccines-approvals-increase-in-india.html https://biospectrumindia.com/news/95/5959/vaccines-approvals-increase-in-india.html Mon, 11 Jul 2011 11:16:00 +0530 There has been a conisderable increase in efforts to tackle a number of prevailing viral infections in the country and this is evident from the presence of the various awareness programmes. Also, there has been an increase in the approvals that have been granted to various companies for manufacturing vaccines, thus providing more options to the suffering population. At least six companies have got permission from the Central Drugs Standard Control Organization (CDSCO) for manufacturing 12 viral vaccines in India. These vaccines target major infectious diseases such as poliomyelitis, pandemic influenza and rabies, which affect a large chunk of population in India. To increase the number of alternatives to tackle polio, approvals were given to manufacturing of three vaccines. Hafkine Bio Pharma, Mumbai, received permission from CDSCO to manufacture bivalent polio type 1 and type 3 vaccine (live oral) to check poliomyelitis. New Delhi-based Panacea Biotec was granted permission to manufacture two vaccines, including a oral poliomyelitis vaccine (type 1, 2 and 3) aimed at active immunization against polio and also received permission for manufacturing bivalent polio type 1 and type 3 vaccine live oral for immunization against type 1 and 3 poliomyelitis. To counter the deaths resulting from the H1N1 pandemic in India, CDSCO gave permission to four companies for manufacturing various vaccines with different compositions targeting different age groups. Panacea Biotec was given a go-ahead on Nov 8, 2010 for manufacturing the inactivated H1N1 split virion vaccine (both adjuvanted and non-adjuvanted) for immunization against H1N1 pandemic influenza. Other firms including, Ahmedabad-based, Cadila Healthcare, received permission on May 11, 2010, to manufacture inactivated Influenza vaccine (whole virion) IP, a pandemic influenza (h1n1, monovalent vaccine) for active immunization against H1N1 virus in age group of 18 years and above. The Serum Institute of India (SII), Pune, was granted permission on June 18, 2010 for manufacturing influenza vaccine (live attenuated freeze dried) for intranasal route to contain influenza diseases caused by pandemic (H1N1). SII was also given permission to manufacture swine A/H1N1 influenza vacine inactivated against the influenza. Hyderabad-based Bharat Biotech International on Sep 30, 2010 received permission to manufacture adjuvanted H1N1 vaccine (inactivated)-HN-VAC for active immunization for H1N1 pandemic influenza. India, China are hubs for generic drugs North America and Europe have traditionally been the major pharmaceutical producers. However, in recent years, because of increased demand from local population and low production costs, several new markets such as India, China, Brazil and Russia have emerged. The growing pharmaceutical infrastructure in these emerging markets is spurring the demand for high-purity water systems, thus creating opportunity for water management companies. In addition, many developed and developing nations are imposing stringent effluent standards on the wastewater that is discharged from drug manufacturing facilities, in order to prevent contamination of water streams. New analysis from Frost & Sullivan, called 'Global Water Market Outlook: Strategic Analysis of Water and Wastewater Management in the Pharmaceutical Industry', revealed that the market for water and wastewater treatment equipment in the pharmaceutical industry recorded revenue of 3,105 crore in 2010 and this is expected to reach 5,625 crore in 2017. The Asian market for water and wastewater treatment equipment in the pharmaceutical industry is expected to grow at a compound annual growth rate of 16.5 percent from 2010 to 2017. Pharmaceutical companies in North America and Europe are outsourcing certain portions of the drug production process to Asian countries and are keen to focus more on R&D. Biocon explores an oral insulin deal Biocon, which is in R&D alliances with Sanofi Aventis and Bristol-Myers Squibb, is looking to capitalize on its present relationship to chalk out an oral insuline deal. An oral insulin deal cannot be ruled out between these firms as it is a very innovative delivery method for insulin. Oral insulin will prove to be a game changer for insulin patients worldwide, when it passes through all clinical trials and hits the market. The value of the insulin deal between Biocon and Pfizer was one of the highest grossing deal in the field of biosimilar drugs. However, a deal for oral insulin would fetch a far greater value as compared to the Biocon-Pfizer deal. The Indian insulin market is presently estimated to be worth 700 crore. The launch of oral insulin will certainly eat into this revenue after the first few years of its launch. A deal with a NDDS with respect to oral insulin will benefit the pharmaceutical industry in India and provide increased global standing to all Indian R&D for novel drug delivery systems. ]]> <![CDATA[Netherlands: Calls for a bio-based economy]]> https://biospectrumindia.com/news/95/1525/netherlands-calls-for-a-bio-based-economy.html https://biospectrumindia.com/news/95/1525/netherlands-calls-for-a-bio-based-economy.html Mon, 11 Jul 2011 11:08:00 +0530 The Netherlands is striving towards an economy that is largely based on natural resources for production of energy, chemicals and materials in such a way that competition with food production is minimal Taking the government, industry, and R&D institutes as the building blocks of the new plan for a bio-based economy, the Dutch ministry of Economy, Agriculture and Innovation has established a roadmap for sustainable development and is inviting investments into the rich sector. The Dutch believe that natural resources can be used to produce much more than just energy; they can be processed to extract valuable components which in turn can be used to produce biochemicals, pharma drugs, biomaterials, bioplastics and much more. â€œThe current investment for the bio-based economy here is 450 million Euros,â€? says Cornelis Mijnders, manager of Holland's national program for bio-based economy. There are companies of all sizes and research institutions that are developing new technologies to process natural raw materials, such as wheat, palm oil, soy, rapeseed, miscanthus, calendula oil, hemp, jatropha, algae, wood and paper waste to be used in agriculture, as additives in paint, to produce construction material, fiber and also chemicals for drugs and cosmetics. The varied technological expertise combined with subsidy schemes for processes like biorefinery pilot and demo, product development, production of second generation biofuels and import of biofuels brings forth Netherlands as a potential place to invest in. The Netherlands Foreign Investment Agency (NFIA) helps by offering one-point contact, personal guidance, tailor-made support and, most importantly, technology matchmaking. â€œWe have a culture of openness to foreign investment, and almost 50 percent of the Dutch GDP comes from international activities,â€? says Bas Pulles, commissioner, NFIA. â€œWe have favourable tax treatment for foreign employees, which otherwise is very high.â€? Netherlands also promotes public-private partnerships. BioSpectrum takes a look at some companies that are doing very innovative work as contribution towards a bio-based economy: Plant extracts for bioplastic Two companies, Avantium and Purac, have patented technologies that use plant extracts to make chemicals which can be used to make bioplastics for manufacturing recyclable and degradable plastic bottles, packaging materials, coatings, polyester fiber and food additives. Purac has developed a new method to make lactic acid from sugar in a process that has low carbon footprint, and is gymsum free. Bacteria derived from nature is used to ferment the sugar, following which separation and purification is done to produce the polylactic acid (PLA). This PLA is being used in producing a host of products like plastic glasses, plastic-coated food boxes, packaging materials, bone screws, biofoam. It can be also used in food products as preservatives instead of lactic acid. Going forward, the company will modify its process, which will use bagasse (byproduct from sugar mills), wood waste and paper waste to derive PLA. The company Avantium, which was formed as a spin off from Shell, has specialized in chemical research and has patented technology to develop resin from biomass by breaking the carbohydrates present in such feedstock into building blocks. This resin is used to make bioplastic and in turn something which is termed as a plant bottle. Avantium boasts of clients like Coke that has vowed to start using these plant bottles for all their packaging purposes in the future. This is called PEF (Polyethylene furanoate). Avantium says that the PEF bottle has six times better oxygen barrier, two times better carbon dioxide barrier, and also two times better water barrier than PET (polyethylene-terephthalate). These characteristics make the bottle safer and longer lasting than PET bottles and allows for packaging of fruit juices also. The company envisages that in future, PET bottles will be fully replaced by PEF bottles. The biggest advantage is that for processing of carbohydrates instead of oil (PEF is made from oil), existing plants can be used and manufacturers wouldn't have to worry about building another huge steel structure. Petten, the energy research capital of Europe, houses The Energy Research Centre â€“ ECN. The ECN does thermochemical conversion of biomass which produces both heat and power, as well as green gas called SNG, which is injected to the grid for industrial and household use. It captures the carbon and reuses it, resulting in zero carbon emissions. The center's biomass gasifier can handle a variety of biological materials. In the final phase, it has developed a special process for removal of tar from the gas produced. The ECN is in talks with Thermax Pune for joint development of plants in India. Tapping the richness of algae Another very interesting development is by Feyecon, which uses carbon-capture technologies towards achieving a host of things like extracting valuable components from algae, extracting components from cannabis to make medicines for nausea, air drying of food products (like mushrooms, raspberries) and encapsulating small particles of active materials with a fine coating, which can retain its value for long. The coating is made of sugar and cellulose-based natural polymers. Components such as iron can be encapsulated into grain composition and can be used for fortifying food products. The company uses pressurized carbon and has identified myriad applications of the same. One of its spin offs, AlgaeBiotech, utilizes Co2 under 100-150 bars of pressure to extract omega-3 rich oils, anti oxidants and herb extracts from algae colorants. And lastly, the company uses the byproduct to make fuel. Feyecon says that algae is a kind of natural renewable resource which has very rich components and fuel should be derived only after extracting all of these valuable components. Novel water treatment A company called Paques in The Netherlands does water purification in a novel form. It removes and extracts phosphate from the water and stores it in crystalline form. It is said that phosphate will become one of the scarcest resources in near future, and hence it is being seen as a smart move to extract and store phosphate to be reused instead of throwing it away. Not only phosphate, they remove ammonia also by adding magnesium oxide. Bacteria is used further to convert the nitrates present into nitrogen gas and the biomass is retained. The company is doing this for the waste water from the largest potato factory in Netherlands â€“ Aviko. Biofuel from byproduct BioMCN lies in Northern Holland, which is known for its agricultural wealth. The company produces biomethanol, which is a biofuel and can be added to petrol. It is derived from crude glycerine, which itself is taken as a byproduct from biodiesel plants from all over the world. Mr Rob Voncken, CEO of BioMCN says, â€œBiomethanol is 75 percent of the price of normal ethanol, and results in Co2 savings of 73 percentâ€?. From the process that BioMCN uses, biomethanol is produced in equal quantities to the glycerine which is used. BioMCN has a refinery which has the capacity of 4,00,000 tons. The Netherlands aptly showcases opportunities in investment in various fields, like export of biomass, setting up of plants, using the technologies and taking the aid of technology experts, and also using the storage capacities of Rotterdam and Amsterdam ports to store products. The Netherlands government promises easy and smooth setup and operations with aid from the NFIA as well. Mr Rajiv Rangarajan, who owns an Indian company Godavari Biorefineries B V, which converts renewable biomass to chemicals and has been doing business in The Netherlands, says, â€œNetherlands was the gateway to the rest of the Europe and has excellent logistics and supply chain services. And when we combine it with the labour and taxation schemes, it becomes a very important and practical destination for investmentâ€?. - Meenakshi Rohatgi from the Netherlands (The author was in the Netherlands at the invitation of the Netherlands Foreign Investment Agency, Dutch Ministry of Economic Affairs, Agriculture and Innovation) ]]> <![CDATA[GLOBAL BIOTECH INDUSTRY RECOVERS]]> https://biospectrumindia.com/news/95/5807/global-biotech-industry-recovers.html https://biospectrumindia.com/news/95/5807/global-biotech-industry-recovers.html Mon, 11 Jul 2011 11:01:00 +0530 HIGHLIGHTS FROM THE WORLD'S LARGEST BIOTECH GATHERING Efficient raising of capital to fuel innovation is the challenge before the global biotech industry, according to the 25th anniversary edition of Beyond Borders: the Global Biotechnology Report 2011 of Ernst & Young (E&Y) The bad days are over for the global biotech industry, which has recovered in revenues and profits following the economic downturn of 2008, with the revenues close to $100 billion and marginal profitability, said Mr Gautam Jaggi, managing editor of E&Y's Beyond Borders report 2011. Releasing the report at a crowded Bio International Conference session in Washington DC on June 28, 2011, Mr Jaggi cautioned the biotech industry about the pitfalls ahead. This industry has to make urgent changes in the business model and improve capital utilization efficiency to sustain innovation. Giving an overview of the sector, Mr Jaggi said the industry, which is primarily measured by the performance of publicly-listed biotech companies in North America, Europe and Australia, increased the overall revenues by eight percent over the 2009 numbers. More importantly, the profitability returned with only one percent margin. The collective R&D spending by the industry has also touched two percent of the revenues as compared to the 13 percent decline in the previous year. The industry managed to raise around $25 billion in capital, as compared to the figures prevalent during the heydays of the industry. However, Mr Jaggi said that there are some signs of warning. Companies that raised the capital used majority of it for retiring debt and restructuring balance sheet. And the actual quantum of investments in innovations, which in the long run would hurt the industry, were modeled on creating new products. With the recovery, employment has increased by four percent over 2009. In the previous year, the employee count had declined by four percent. The number of new drugs approved by the US regulator, FDA ( Food and Drugs Administration) in 2010 was only 21 as compared to 26 in 2009. â€œThis is a sign of a cautious regulator not taking too many risks in the post-Vioxx withdrawal period,â€? said Mr Jaggi. In such a scenario, E&Y prescription for the industry: Do more with less funds through increased research efficiencies and prove or lose it early. This implies that the companies will have to arrive at conclusions to go ahead and stop work on novel compounds earlier than usual. â€œThe pressures on the biotech business model have now increased to extraordinary levels, even by the standards of an industry that has for long faced funding constraints,â€? Mr Jaggi wrote in the report along with co-author Mr Glen Giovannetti, the global leader of E&Y life sciences program. The statistics tell the tale. Biotech industry growth is fueled by venture capital investments for promising start-ups. However, in the US, venture capital (VC) raised has declined by nearly 20 percent in the last two years. And VCs are increasing the share of investments in hot social media ventures at the cost of biotech companies. Adding to the problems of biotech companies is the trend of funds being disbursed in tranches, Mr Jaggi said. So, biotech companies now do not get all the promised funds upfront but in tranches, tied to milestone payments. This has the potential to further increase pressure on innovative biotech companies to show results more quickly and consistently. ANTI-CANCER DRUG AVASTIN LIKELY TO BE WITHDRAWN A panel of experts at the US regulator, Food and Drugs Administration (FDA) has recommended withdrawal of Genentech's blockbuster breast cancer treatment drug, Avastin, on the ground that it is actually harmful to the patients. Health experts of FDA ruled that it does not provide significant cure but, in fact, endangeres patients with breast cancer. With annual global sales of $6.8 billion (30,600 crore), Avastin is the world's largest selling biotech drug. FDA's decision to withdraw the drug, during late 2010, was challenged by Genentech, which is owned by German drug maker, Roche. The matter went to a six-member advisory committee, which recommended unanimously that the drug be withdrawn. FDA commissioner, Ms Margaret A Hamburg, will take the final call. Usually the FDA heads do not overrule the decisions of expert committees. Avastin could, however, be used in other treatments. For breast cancer patients, a year's treatment using Avastin costs over $88,000 (45 lakh). Presently, over 17,500 women in the US are undergoing Avastin treatment. â€œWe are very disappointed by the committee's recommendation,â€? said Mr Hal Barron, Genentech's chief medical officer, in a media statement. â€œWe remain ready to collaborate with the FDA to find a solution that is in the best interest of patients who need Avastin.â€? This latest decision is likely to further put pressure on FDA as there has been widespread condemnation that the agency was too risk-averse. Many demonstrators appeared near the agency's office with placards asking FDA to â€œSave Avastin, Save Women.â€? Appearing at a panel discussion at the Bio International conference, FDA commissioner, Ms Hamburg defended the agency's science-based decision. While other panelists and participants too voiced their concern that American citizens were becoming too â€œrisk-averseâ€? and this has an impact on the decisions taken by policy makers. This approach is increasing the cost of conducting clinical trials and other compliance measures and it costs now nearly $1.5 billion (6,750 crore) to bring a new drug to the market, compared to just $1 billion (4,500 crore) five years ago, or $100 million (450 crore) 20 years back, many industry veterans said during the discussions. INDIA PAVILION ATTRACTS GLOBAL ATTENTION Dr M K Bhan, secretary, Department of Biotechnology, inaugurated the India pavilion at the BIO exhibition in Washington on June 29. The pavilion, being showcased at the four-day event, was supported by the Confederation of Indian Industries (CII) and the Association of Biotechnology Led Enterprises (ABLE) along with the Department of Biotechnology, Govt of India. Mr Arun Kumar Singh, deputy chief of the mission, Embassy of India in the US and Dr Rajesh Jain, chairman of CII national committee on biotechnology and joint managing director of Panacea Biotec, were among the many dignitaries present at the inauguration. Many industries and state governments of India participated in the exhibition that drew a lot of attention from the global biotech players looking for collaborations. The yearly exhibition was preceded by the CII's 10th Biotech Mission to the US. About 45 Indian delegates participated in the mission led by Dr Bhan and Dr Jain. The delegation visited premier institutions like the National Institutes of Health, University of Maryland and Johns Hopkins University. DR PAUL OFFIT GETS BIO AWARD Dr Paul Offit, the co-inventor of the rotavirus vaccine and a leading American scientist, was honored with the Biotech Humanitarian of the year 2011 award by the Biotechnology Industry Organization (BIO) at Washington convention. Mr Jim Greenwood, president of BIO, presented the award to Dr Offit, who is currently the director of the Vaccine Education Center at The Children's Hospital of Philadelphia, US. Dr Offit has spent 25 years to develop RotaTeq, one of the key vaccines against rotavirus infection. RotaTeq has been recommended for use in children to save them from crippling dehydrating diarrhea. US LAUNCHES BIOTECH PODCAST FOR CHINA The US has launched a Mandarin version of a radio program on biotechnology. The program's host, Dr Moira Gunn, announced that the weekly biotech segment of Tech Nation will be podcast through the Internet in Mandarin, China. It will be called BioTech Nation China and will be hosted by Dr Xiaohua Yang, a professor of management at the University of San Francisco. MALAYSIA, A HOT DRAW Agila Specialities Sdn Bhd, a subsidiary of India's Strides Arcolabs, is set to spend $40-60 million to set up a manufacturing facility at the biotechnology park in Malaysia. Bio-XCell, the investment arm of Malaysian Biotechnology Corporation, also sealed a strategic partner agreement with MOX-Linde Gases Sdn Bhd to supply industrial gas for use of biotechnology companies located in the park. TAIWAN COS SIGN DEAL WITH PHARMANET Taiwan-based pharmaceutical companies will collaborate with a leading western CRO, PharmaNet Development Groups. Non-profit Pharmaceutical Industrial Technology Development Center (PITDC) and Pei Lei Pharmaceutical Company signed mutual cooperation agreements with the CRO on the opening day of the conference. PITDC also signed an agreement with Aihol Biomedical for co-developing some drugs. 26 FIRMS PART OF KIWI SHOW More than 26 New Zealand companies showcased their capabilities in human health care, animal husbandry, plant and food research, research technologies and more at the convention. The country displayed its 150 years of expertise in genetic improvement of animals and plants, and world-class research institutions led by industry organizations, NZBIO and New Zealand Trade and Enterprise. QUEENSLAND PUTS IN $100 MN FOR BIOTECH The State of Queensland in Australia announced an additional $100 million grant in the state budget to boost investments in the biotechnology sector and attract researchers. The funds will be used to co-invest with industry, universities and the Commonwealth, said Ms Anna Bligh, premier of the State of Queensland. The Australian delegation at the convention included scientists, researchers and executives from the state of Victoria, which has long been the hotbed for biotech innovation down under. - Narayanan Suresh in Washington D C ]]> <![CDATA[MS MARKET BACK IN SHAPE: CLOCKS INR 230 CRORE]]> https://biospectrumindia.com/news/95/2214/ms-market-back-in-shape-clocks-inr-230-crore.html https://biospectrumindia.com/news/95/2214/ms-market-back-in-shape-clocks-inr-230-crore.html Mon, 11 Jul 2011 11:00:00 +0530 After experiencing a slide in the last fiscal, Mass Spectrometry has made a comeback this time with a growth of about 20 percent. The projections point to similar kind of growth in 2011-12 as well In India, the mass spectrometry (MS) market started picking up from the year 2000. With the adoption of technology, it slowly made inroads into the market and the trend continued with the market growing at a steady rate of 20-25 percent until 2008. However, the year 2009 was not good for MS market and it shrunk due to global economic meltdown. - MASS SPECTROMETRY - After a brief slowdown, the Indian market has slowly picked up and it witnessed more than 20 percent rise in business during the last fiscal. According to BioSpectrum estimates, the business for MS was over 230 crore ($50 million) in 2010-11. The major share of this business has come from triple quad MS technology. This growth momentum is expected to continue in the coming years, thanks to the sustained investment in pharma and CRO industry, spurt in food safety and increased funding to academia. The companies such as ABI, Agilent, Bruker, Shimadzu, Thermo, and Waters are the leading players in the market. Estimated revenue for MS systems during 2010 was about 230 crore ($50 million) ABI, Agilent, Bruker, Shimadzu, Thermo and Waters are the leading players in the market Triple quad MS continues to be the major contributor in this segment The MS market consists of single quadrupole, triple quadrupole, ion trap, MALDI and high resolution mass spectrometry. The new high speed triple quad from Shimadzu last year has gained momentum in the market place. The other appreciable trend is to use UHPLC as front end to increase lab productivity. Also, even as the market is picking up high-end solutions, however, triple quad is maintaining a matured growth. The leaders in the segment are ABI Sciex and Waters. In June 2011, ABI Sciex launched SelexION Technology aimed to improve performance of any application requiring the separation of isobaric species, isolation of challenging co-eluting contaminants and elimination of high background noise. The major player in the segment is ABI Sciex with almost 45 percent market share followed by Waters (25 percent). Thermo Fisher holds another 15 percent followed by Bruker (5 percent). Though ABI Sciex (distributed through LabIndia) continues to enjoy the market leadership but its total share reduced significantly in 2009, compared to previous years. According to industry sources, the major orders were bagged by ABI Sciex followed by Waters, Thermo Fisher and Bruker. Bruker, which is a relatively late entrant in this segment, is a worldwide leader in MALDI, TOF and MALDI-TOF mass spectrometry, not just in proteomics but also in genomics. The number of these instruments in industry and academia has grown considerably. ABI has more than 200 installations all over India and Agilent has close to 40 in Bangalore alone. Few of the examples of successful installations include a high-end MALDI-TOF and a TOF-TOF in Jawaharlal Nehru Centre for Advanced Scientific Research (JNCASR). Besides that, there are high-end MS instruments in IISC, Bangalore. Also there is a MALDI-TOF-TOF installed at Jawaharlal Nehru University and around six instruments are at The Centre for Genomic Applications (TCGA), New Delhi, and the National Institute of Pharmaceutical Education and Research (NIPER), Chandigarh. The high-performance mass spectrometers spurred good revenue growth at Waters and ABI Sciex, with the companies reporting strong sales of instruments like Waters' Synapt devices and ABI Sciex's TripleTOF 5600. In the year 2010, Waters further bolstered its high-end mass spectrometry line with the release of the Xevo G2 QTof machine. The transition of Labmate from erstwhile distributor to a majority-owned Bruker company has also boosted the future prospects of Bruker in the Indian market. In 2009, along with Bruker Daltonics, Labmate established a spectrometry joint venture called Bruker LabMate. The benefit with the mass spectrometer is that it is more universal and decisive than any other GC and LC detector, therefore there is the possibility that the market will shift more and more towards mass spectrometry. It is also expected that the regulatory bodies will also insist more on methods based on mass spectrometry. Although the Indian MS market, currently, holds a small share at the global scale, the above trends certainly point towards a bright future. ]]> <![CDATA[AT 30 PERCENT GROWTH, A MIXED BAG OF PERFORMANCES]]> https://biospectrumindia.com/news/95/4544/at-30-percent-growth-a-mixed-bag-of-performances.html https://biospectrumindia.com/news/95/4544/at-30-percent-growth-a-mixed-bag-of-performances.html Mon, 11 Jul 2011 10:57:00 +0530 While growth in the overall centrifuge market slackened in 2010-11, the PCR market showed an impressive growth with biotech companies in India moving towards high-end drug discovery research CCentrifuges holds the major share of the life sciences instrumentation market, which also comprises sub-segments like flow cytometry, PCR, spectrophotometer and electrophoresis. While these sub-segments continued to predominate the lab instrumentation market in India, upcoming segments like gene and protein sequencing displayed impressive growth over the past one year and could play a significant role in the market. - LAB INSTRUMENTATION - Centrifuges holds the major share of the life sciences instrumentation market, which also comprises sub-segments like flow cytometry, PCR, spectrophotometer and electrophoresis. While these sub-segments continued to predominate the lab instrumentation market in India, upcoming segments like gene and protein sequencing displayed impressive growth over the past one year and could play a significant role in the market. The total lab instrumentation market for 2010-11 stood at 1,350 crore as against 920 crore in 2009-10. This amounted to a registered growth of 30 percent over the previous fiscal. While homegrown companies are gradually entering this segment, multinational companies continued to be the major players, like in previous fiscals. These include Thermo Fisher Scientific, Beckman Coulter, Becton Dickinson, ABI, Eppendorf, Perkin Elmer, Roche, BioRad and GE Healthcare. A common trend observed in all the sub-segments was the increasing demand for high-throughput instruments. This is due to the rise of high-end drug discovery research in India. A sizable part of the revenue for most companies came from the public sector. The total lab instrumentation market stood at 1,350 crore All the sub-segments witnessed an increasing demand for high-throughput instruments Centrifuges market clocked total sales of 112.5 crore PCR market (both the classical and real time PCRs) stood at about 80-100 crore Demand for RT PCRs is gradually rising in the market Flow cytometry market showed a drop and clocked total sales of 112.5 crore Spectrophotometer market clocked sales of 80 crore and is growing at 8-10 percent The centrifuges market recorded a slow growth in 2010-11 as compared to the previous fiscals. This was primarily due to the slow growth of vaccine companies in India, which last year had majorly invested in H1N1 vaccine production but did not see much growth in sales thereafter. The total centrifuges market clocked total sales of 112.5 crore ($25 million) in 2010-11 as against 100-120 crore in 2009-10. This segment further has its divisions, which includes ultra centrifuges, high speed centrifuges and tabletop centrifuges. This apart, it also comprises industrial centrifuges and blood centrifuges. The ultra centrifuges market saw a major drop with its total market clocking 15.75 crore ($3.5 million) due to the impact of vaccine companies in India. The same is the case with the high speed centrifuges market that clocked 15.75 crore ($3.5 million). The market for tabletop centrifuges - by far the largest within this space - recorded total sales of 36 crore ($8 million) in the fiscal as against 36.8 crore in 2009-10. During the year, an average of 1,000 units of tabletop centrifuges were installed. The industrial centrifuges segment clocked 31.5 crore ($7 million) while blood centrifuges clocked 13.5 crore ($3 million). In the ultra centrifuges segment, Beckman Coulter held a leading share of around 65 percent. In high speed centrifuges too, Beckman Coulter was leading with 55 percent share followed by Thermo Fisher Scientific. Eppendorf dominated the tabletop centrifuges segment with a market share of 60 percent. Alfa Laval was a major player in the industrial centrifuges market. In the coming years, the same players will continue to dominate this segment, while simultaneously more players will enter the tabletop centrifuges segment making the overall segment extremely competitive. The PCR market (both classical and real time PCRs) was about 80-100 crore in 2010-11 as against 55 crore in 2009-10. While the size of the classical PCR market stood at 45 crore, the real time PCR market stood at around 35 crore during the fiscal. Around 1,500 units of classical PCRs and around 250-300 units of RT PCRs were sold during the year. Major clients for most of the PCR players were research institutions mainly into molecular diagnostics, forensic laboratories, pathology laboratories and institutes involved in genomic research. Major companies in the classical PCR space include Eppendorf (30 percent share), ABI (15-16 percent share) and BioRad (30 percent). In RT PCRs, major companies include ABI (30 percent) and Roche (20 percent) followed by BioRad and Eppendorf. The classical PCRs registered a growth of 10-15 percent in the market, while real time PCRs showed a gradual impressive growth of 20-25 percent. While most of the clients still opt for classical PCRs, the demand for RT PCRs is gradually rising in the market. Most of the demand for PCRs came from the crop sciences sector that has large scale lab set-ups where the number of PCRs installed can be anywhere between 8-10 per lab. Major pocket areas for PCR sales in India include Hyderabad, Bangalore and Aurangabad, the hubs for most big seed player companies in India. This trend will continue to grow with both multinational companies and Indian companies setting up testing labs for a vast array of food crops like rice, maize and vegetables. Also, there has been a paradigm shift with India moving into high-end discovery research rather than merely being a destination for drug development. This has proved to be a blessing for PCR companies in India whose sales grew with companies buying high throughput PCR instruments for high-end research. Of late, the overall PCR segment has witnessed the entry of Chinese players who supply PCR equipment in India. The flow cytometery market also showed a drop and clocked total sales of 112.5 crore in 2010-2011 as against 115 crore in 2009-2010. This is due to the fact that these high-end instruments, require large-scale investments and are still in their nascent stage of growth. However, over the past one year, companies have been gradually adopting the technology. Again, like PCRs, high throughput equipment also remain the demand of the day. The growth is expected to touch 15 percent in the coming years. Approximately 50-60 units of flow cytometers were sold during the year. Major sectors where there has been a rising demand for flow cytometers include research institutes, diagnostics and imaging companies. Becton Dickinson, by far, is the leading player in the flow cytometry market. Another upcoming segment is the gene sequencing market where the new generation sequencing (NGS) space is witnessing a rapid growth of around 30-35 percent due to the growth of reagents market in India. Till date, around 20-30 NGS equipment have been installed, while last year around 10 such equipment were installed. In the coming year, industry observers predict that an average of 20 NGS equipment would be installed. However, this industry is facing cost issues. The spectrophotometer market clocked sales of 80 crore and is growing at an average rate of 8-10 percent. Around 300 units of such equipment are sold every year. Major players in the segment include Thermo Fisher, Shimadzu and Eppendorf. ]]> <![CDATA[CONSUMABLES KEEP UP THE PACE]]> https://biospectrumindia.com/news/95/2805/consumables-keep-up-the-pace.html https://biospectrumindia.com/news/95/2805/consumables-keep-up-the-pace.html Mon, 11 Jul 2011 10:56:00 +0530 The increased market potential for lab consumables has seen many global players setting up either a direct subsidiary or a joint venture with their erstwhile distributors. Cashing in on the new opportunities, this ever-growing segment has been able to maintain its pace, registering close to 25 percent growth in 2010 The lab consumables market occupies the largest slice of the biosupplier market. According to industry sources, the overall consumables market is close to 2,600 crore. Benefiting from its immunity to fluctuations, the segment has registered a growth of 25 percent in 2010. The segment is made up of various sub-segments such as plastic-ware, glassware, molecular biology reagents and instrument-related consumables such as plates, columns, tubes and reagents. Microplates, DNA kits, oligonucleotides and gels are also a part of laboratory consumables. The general consumables are estimated at close to 1,000 crore, while the reagents market is said to be close to 1,200 crore. The culture media business is estimated to have registered a revenue of 150 crore. There are many sub-segments within this and, interestingly, there are many players who are leading each segment. - LAB CONSUMABLES - The general consumables segment, estimated to be close to 1,000 crore, has players like Merck, Rankem (RFCL), Thermo Fisher and S D Fine Chemicals controlling 50 percent market share. The molecular biology market is estimated to be close to 275 crore. Sigma-Aldrich has a monopoly over this segment, while players such as Life Technologies are trying to make inroads into the market. After acquiring Bangalore Genei, Merck has been able to tap its market catering to schools and colleges, which is close to about 30 crore. The major trend that is said to have led to a hindered growth is the shift of focus from genomics to proteomics and antibodies. Companies such as Stratagene, Promega and New England Lab also have a good share through various distribution networks in the country. The oligos market is steady and is estimated to be close to 15 crore. Life Technologies, Sigma and Qualigen purification kits also registered 15 percent growth. The culture media, is said to be close to 150 crore has grown at the rate of 15 percent. The dominant players here are Difco and Hi Media. The prices in this sub-segment are melting because of huge competition. GIBCO also maintained supremacy in the FCS and FBS area. HiMedia continued to hold a strong position in the culture media space in India. The chromatography consumables market is also huge and the requirements are mostly met by the companies selling instruments in the area. The market for this segment is estimated to be close to 230 crore. The consumables in this sub-segment include columns, vials and syringes. Companies such as Agilent and Waters have been supplying their consumables for the chromatography instruments through a wide network of distributors throughout the country. Overall lab consumables market is about to 2,600 crore The general consumables are estimated at 1,000 crore The reagents market is close to 1,200 crore The culture media business is around 150 crore Chromatography consumables market is estimated to be close to 230 crore The plastic-ware and glassware markets are said to be close to 145 crore, registering a growth of three-to-five percent in 2010. This sub-segment according to industry sources is growing at a very sluggish rate and there is a possibility of de-growth in the coming years. Borosil continues to hold a major share of the glassware segment followed by Corning with its range of glassware that addresses the quality needs of the high-end labs. Besides, the glassware supplied by chemical suppliers such as S D Fine Chemicals and the unbranded Chinese ones hold substantial chunk of the market share. In 2010, the segment witnessed the MNCs increasing their direct presence in the India market. The acquisition of Gurgaon-based LabIndia by Life Technologies and the takeover of New Delhi-based RFCL by US-based Avantor Performance Materials Holdings is expected to further boost the product and service offerings of these companies. Even Qiagen, since early 2011, has entered directly into the Indian market and more companies are expected to be added to this list. Many smaller companies in this segment are planning to venture into research and development and manufacturing of lab reagents. The competition between the principal companies and erstwhile distributors is also an interesting phenomenon to watch. The setting up of DSS Takara Bio at Delhi to manufacture reagents is a case in point. And with many other distributors either planning or moving into manufacturing of reagents, the competition is only expected to hot up. ]]> <![CDATA[BUOYED BY MARKET DYNAMICS]]> https://biospectrumindia.com/news/95/1151/buoyed-by-market-dynamics.html https://biospectrumindia.com/news/95/1151/buoyed-by-market-dynamics.html Mon, 11 Jul 2011 10:54:00 +0530 After showing decline due to economic downturn in 2009, the chromatography segment grew at a rate of 25 percent in 2010 due to investments and increased funding to the life sciences industry The chromatography market in India is estimated to be around 1,100 crore. The segment holds close to one-third of the total biosuppliers market share. While the market is dominated by Agilent and Waters, Shimadzu and Thermo Fisher also have a strong presence in the segment. The segment is majorly divided into high performance liquid chromatography (HPLC), liquid chromatography (LC), gas chromatography (GC) and ultra-high performance liquid chromatography (UPLC). - CHROMATOGRAPHY - The favorable market dynamics in India coupled with the technological advancements in instrumentation, have led to the growth of the separation market. The growth drivers for this market include the government investment in academics, life science applications, growth in generics and CROs, and therapeutic conversion to new biological entities. More efficient and faster analyses have led to significant new developments in chromatography in recent years, notably UPLC, monolithic columns and hydrophilic interaction chromatography (HILIC). The HPLC market witnessed strong growth opportunities of 25 percent for fiscal year 2010-11 and the total HPLC market of India is expected to be about 500 crore ($260 million). The tremendous increase in the number of quality control, method development, research and drug discovery laboratories has been the driving force for the HPLC market. The technological advancements with advent of systems for faster analyses have also opened up newer opportunities of growth. Of the estimated 3,000-plus HPLC units supplied, the pharma market accounts for about 70 percent. Chromatography market in India is about 1,100 crore Agilent, Waters, Shimadzu and Thermo Fisher are the major players in the segment Gas chromatography witnessed a growth of eight percent in 2010 HPLC market witnessed strong growth opportunities of 25 percent in 2010-11 Total HPLC market in India is about 500 crore Ion chromatography market is quite small, but is increasing at a rate of 20 percent Proteomics and other life sciences applications have propelled the growth in academia and biotech industries, accounting for about 10 percent of the market. National laboratories and other government institutes, also a major segment for HPLC, have an equal share in it. There are a host of other non-pharma industries like chemicals, pesticides, food and beverages, that use HPLC extensively. The demand from independent testing labs is increasing due to continued outsourcing from pharmaceutical industries. These segments will account for the remaining 10 percent share of the market. Fast LC is indeed the growth engine today contributing to the enhanced growth of analytical HPLC. This technique is gaining wide popularity with a growth rate of 20 percent as per a market study. Fast LC applications can be accomplished with either elevated temperatures or increased pressure. According to BioSpectrum estimates, the LC market is about 300 crore, thereby accouting for 30 percent of the total separation market. The UPLC has rapidly grown out of its infancy and moved into analytical labs. Monolithic columns also hold great potential for very fast separations. In 2004, Waters introduced Acquity UPLC â€“ Ultra Performance Liquid Chromatograph using columns packed with particle sizes of 1.7 micron and advances in instrumentation designed to deliver 15,000 psi. Other vendors have also brought out fast LCs with a similar objective and the additional feature of compatibility with standard HPLC equipment. Agilent offers rapid resolution liquid chromatograph (RRLC) mentioning that the method developed on a conventional HPLC can be transferred seamlessly to an RRLC. Shimadzu has launched ultra fast liquid chromatograph (UFLC) offering high throughput but without high pressure. Thermo has launched Accela High Speed LC that has been designed to optimize performance of subâ€“two micron particle columns. Another sub-segment, ultra-high-pressure liquid chromatography (UHPLC) due to its advantages in chromatographic resolution, speed, and sensitivity over conventional HPLC systems, has increased its presence substantially. This particular sub-segment is expected to gain another five to 10 percent of the market in the next two-to-three years. Waters in FY 2010-11 launched a new 1,290 Infinity UHPLC. The Indian ion chromatography (IC) market is quite small as compared to the developed countries but is rapidly increasing at an estimated rate of 20 percent. Environmental monitoring and life sciences are leading in the use of ICs in India and 100 to 120 ICs are purchased annually. Dionex is leading the market in the high-end segment that requires gradient systems, especially in the biotechnology sector where it has unique chemistry. The low-end market is shared between Dionex and Metrohm. Gas chromatography (GC), which is another big sub-segment, holds a considerable chunk of separation market. This sub-segment is said have grown at the rate of eight percent in 2010. In the case of Indian market, 1,300 GC units were estimated to be sold in 2010. Of the total GC units sold, Indian manufacturers hold close to 50 percent share with Chemito having the major share in the market. Foreign manufacturers like Agilent, Perkin Elmer, Shimadzu and Thermo contribute to the remaining market. The acquisition of Varian by Agilent in 2010 also added fuel to the growth trajectory of the company and helped it in increasing its presence, especially in gas chromatography. The visible trend in this segment is the gradual shift towards GC-MS. With government funding towards research and development set to register an increase and also the major MNCs investing heavily in R&D, the chromatography segment is expected to maintain a 25 percent growth in the current financial year as well. ]]> <![CDATA[Disposables drive a modest 12 percent growth]]> https://biospectrumindia.com/news/95/2571/disposables-drive-a-modest-12-percent-growth.html https://biospectrumindia.com/news/95/2571/disposables-drive-a-modest-12-percent-growth.html Mon, 11 Jul 2011 10:51:00 +0530 Companies have increased use of single-use devices/disposables to cut down on capital costs and gain maximum return on investments The bioprocesses segment continued to witness a moderate growth of about 12 percent, thus taking the segment to a total market size of around 504 crore in 2010-11 as against 450 crore in 2009-10. The space continues to be dominated by three large players, namely Millipore (now Merck Millipore), Pall Life Sciences, Sartorius and to some extent GE Healthcare. Millipore, by far, is the leading player in the total bioprocess market followed by Sartorius and Pall Life Sciences. These three companies together have an amalgamated share of around 80-85 percent. Millipore and Sartorius have a share of over 30 percent each, while Pall Life Sciences has a market share of 15-18 percent. In 2008, GE Healthcare acquired Whatman Plc, which was a leading company in filtration products. This helped former grab a sizable share in the global as well as the Indian market. - BIOPROCESS - There has been an increase in the use of single-use fluid devices and disposables. In the pure biotech sector, most companies have adopted this technology and the rate of change is very high. However, in the pharmaceutical and API companies, the switch towards single-use fluid/devices is slower but is gradually picking up. There are myriad reasons for this trend. The past one year has seen increasing regulatory pressures, which in turn has prompted companies to embrace this technology. Adopting single-use fluid handling bags over multiple-use devices makes economic sense for biotechnology/pharmaceutical companies who look at maximum returns but low-cost capital investments. While the investments required in re-using/cleaning the same equipment is much higher, single-use devices involve lesser costs. The market size of the bioprocesses segment stood at 504 crore in 2010-11 The segment grew at 12 percent in the fiscal The space continues to be dominated by Millipore (now Merck Millipore), Pall Life Sciences and Sartorius Millipore and Sartorius have a share of over 30 percent each, while Pall Life Sciences has a market share of about 18 percent Apart from economical factors, single-use fluids are a viable option for vaccine-makers and companies into anti-cancer products, which require high adherence level to quality and safety norms. Above all, major share of the business of most of the top biopharmaceutical companies in India today (both multinationals and homegrown companies) comes from exports, for which high quality assurance levels have to be maintained. In such a situation, single-use fluid handling bags are preferred. The main highlight last year was the final integration of Merck and Millipore after the former's global acquisition of the latter. Following the global acquisition of Millipore Corporation by Merck KGaA in 2009, in India, the business of Millipore India was integrated with Merck's Life Science and Chemicals business to form a new business division, â€œMerck Milliporeâ€?. Post integration, the amalgamated division's restructured business comprises three units - the biosciences unit, lab solutions and process solutions unit. Looking ahead, industry observers predict that the segment will see a growth of around 12 percent. Upcoming technological sub-segments will include membrane chromatography and chromatography monolithic columns. The same players will continue to dominate the market. Though the segment has witnessed the entry of a lot of homegrown players, it will be a while before local players can catch up with the investments and revenue levels that the MNCs command today. ]]> <![CDATA[Guwahati BT Park ready to host firms]]> https://biospectrumindia.com/news/95/4514/guwahati-bt-park-ready-to-host-firms.html https://biospectrumindia.com/news/95/4514/guwahati-bt-park-ready-to-host-firms.html Mon, 11 Jul 2011 10:49:00 +0530 Guwahati Biotech Park is looking for companies to set up their units in the Guwahati Biotech Park Incubation Centre (GBPIC). The biotech park, which provides an excellent opportunity to the entrepreneurs of North East India, has a ready-to-use space available in the Technology Complex at IIT Guwahati. The common facilities that are available at the park include, a bio-business center consisting of meeting rooms, conference halls and a cafeteria; a central instrumentation facility featuring technologies such as LC MS/MS, HPLC, MS directed autopurification system, GCMS, CHNS elemental analyzer, FT-IR, florescence spectrophotometer, UV spectrophotometer, speedvac and ultracentrifuge and other molecular biology equipments. Moreover, facilities such as a common effluent treatment plant, spectroscopy grade water, 24X7 hours security, uninterrupted power and water supply are also offered at the park. Situated in the northern bank of the river Brahmaputra, the Guwahati Biotech Park, provides a platform to promote entrepreneurship in North East India. The park is surrounded by lush green environment and is located in close proximity to premier institutes including IIT Guwahati, Assam Engineering College, Institute of Advanced Studies of Science & Technology, Guwahati University and the Brahmaputra Industrial Park. Launched by an autonomous society under the Government of Assam, the biotech park will have facilities to support the preparation of medicinal plant master database of North East India, databases for assessment of local health traditions, database on clinically important plants of ayurveda from North East India, pharmacognosy bulletin on trade and medicinal plants and multi-lingual website programme on home doctor. The major focus of the biotech park is to boost the states that are renowned healthcare practitioners of ayurveda by synerging traditional knowledge with scientific validation and technical product profiling and clinical database. The park would also set up an R&D center to study and introduce new techniques for extraction of medicinal plants and testing for various target organisms. The park is also expected to promote discovery of new chemical entities (NCE) from natural products of terrestrial, microbial and marine origin. The biotech park and its facilities are expected to boost the healthcare and pharmaceuticals sector of North East India. India to increase access to ARV Therapy India has called for proactive and collective action from the international community to dismantle trade and intellectual property right barriers and improve the availability of accessible, affordable and quality drugs for the needy and impoverished. Mr Ghulam Nabi Azad, the Union Minister of Health and Family Welfare, Government of India, while speaking at the high level meeting of the General Assembly on HIV and AIDS in New York, highlighted India's efforts on prevention, treatment, care and support of HIV and AIDS. He said that India was able to contain the epidemic with a prevalence of just 0.31 percent. Indias, focus has been on high risk groups, expanding services and improving access to anti-retroviral (ARV) therapy. Pharmaceutical companies in India have been providing high quality and affordable drugs for use not only in India but also supplying to around 200 countries. The minister pointed out that it is important that considerations of commerce and profitability are not used to erect artificial barriers between life and death. Another crucial barrier in universal access to treatment that needs to be addressed is the high cost of anti retro viral medicines. Lucknow BT Park steps up agri-biotech efforts Lucknow Biotech Park has stepped up its efforts to promote agriculture in the northern part of the country. More than 500,000 banana plants of the high quality G-9 variety are available at the biotech park for immediate supply. These plants have been cultivated according to the standards and specifications laid down by the Department of Horticulture, Government of Uttar Pradesh and are free from virus. District Horticulture officers and farmers can procure these at the government approved rate of 13 per plant. The eight-acre biotech park was set up in the year 2001 with an aim to provide facilities to biotech companies in the area. There are numerous facilities that are operated under public-private partnership at the park including, the biofertilizer unit, which is being run alongwith Hindustan Bioenergy. Also, there is the tissue culture and hardening facility, being operated in collaboration with Sheel Biotech. Few of the tenant companies at the park include, ABC Genomics (India), Chandan Healthcare, Cognate Bioservices, Genetech Laboratories, H H Biotechnologies, IQRA Biotech Services, Life Care Innovations, Rama Associates and Vivo Biosciences. ]]> <![CDATA[Biotech's sweet smell of growth]]> https://biospectrumindia.com/news/95/1573/biotechs-sweet-smell-of-growth.html https://biospectrumindia.com/news/95/1573/biotechs-sweet-smell-of-growth.html Thu, 09 Jun 2011 16:14:00 +0530 After two years of comparatively stagnant growth, India's biotech industry has got back into its groove. In the last fiscal year of 2010-11, the industry has topped the 20 percent annual growth mark once again after a gap of two years. According to the 9th BioSpectrum-ABLE Biotech Industry Survey 2011, done in April-May, the industry, has grown by 21.5 percent to reach 17,400 crore in revenues in 2010-11. In dollar terms, it is slightly less than the $4 billion. But on adding the estimated revenues of 1,150 crore generated by the nearly 400 private and public educational institutions from their biotech courses, the overall revenues crosses the $4 billion ( 18,400 crore) mark for the first time ever. The industry had its annual gathering at Bangalore India Bio in early May. It is time for the industry to come together once again to pat each other and exchange some high fives. India's biotech industry has few saviors. The most prominent savior is the BioAgri industry. With the cotton farmer lapping up every Bt cotton seed produced by the two dozen companies, this sector is on a growth path. With five BioAgri companies in the 9th BioSpectrum-ABLE Top 20 Rank, the revenues from this sector are providing a cushion to the industry collectively. Another remarkable fact this time is the higher than industry growth achieved by some of the prominent members of the BioSpectrumâ€“ABLE Top 20 companies, the industry has a healthy picture to present. The Top five companies have grown in excess of 25 percent in the last fiscal year. Interestingly, the share of the Top 20 companies in the overall industry revenues has declined by seven percent, from 53 to 45 percent this year. This indicates that companies beyond the Top 20 list are also gaining traction and contributing significantly to the overall growth. As the industry matures, the share of the Top 20 companies should decline gradually. Overall, the industry generated over 3,000 crore in revenues over the previous year. The Top 10 companies accounted for nearly two-thirds of the net income generated by the industry collectively. Biocon has maintained its No.1 rank for the second consecutive year, backed by strong growth in its key markets. The diversified portfolio built up in the last few years is adding muscle to Biocon's growth. The No.2 company, Serum Institute of India has also recovered from its previous year's slump, thanks to the robust sales of the newly introduced swine flu vaccine. Bharat Biotech has surged past its industry rival and pioneer Shantha Biotech in revenues. Shantha Biotech, now a part of the Sanofi Pasteur Group, had a few setbacks due to the withdrawal of some products from the market last year. This survey has completed nine years. Even after nine years, the landscape of the biotech cluster remains more or less the same. The western and southern biotech clusters account for an overwhelming share of the industry with the northern cluster just in double digit share. The eastern region continues to remain insignificant in the overall biotech scheme of things. The southern and western clusters are neck-to-neck in the revenue race with very little to separate these two dominant regions. The government is pushing the industry to the eastern parts of the country. It has set up some research centers which should form the nucleus of the sector in the coming decades. The details of the 9th BioSpectrum-ABLE Industry Survey 2011 are available in the magazine. We have tried to provide more tables and analysis with the limited data shared by the industry for this purpose. I look forward to the suggestions to make the next edition of the survey even more useful to everyone. Narayanan Suresh Chief Editor sureshn@cybermedia.co.in ]]> <![CDATA[Top 46-50]]> https://biospectrumindia.com/news/95/2174/top-46-50.html https://biospectrumindia.com/news/95/2174/top-46-50.html Thu, 09 Jun 2011 15:26:00 +0530 Synchron Research Services Synchron Research Services reported an estimated revenue of 63 crore in 2010-11 as compared to previous year’s estimated revenue of 57 crore. It is a leading CRO in India, which provides a broad range of clinical research services from phase I to phase IV, including bioavailability, bioequivalence, pharmacokinetic, pharmacodynamic studies, dermato-pharmacokinetics, bioanalysis, statistical analysis, data management and pharmacovigilance. It has a 30-bed facility in Bangkok called Bio-Innova Synchron Research to serve the Asia Pacific region, which was formed by a joint venture between Bio-innova and Synchron Research. Synchron also acquired Innovance, an Ahmedabad-based start-up CRO having a clinical research facility. The new clinical facility is spread across 18,000 sq ft on a single floor, with three different volunteer housing areas. The new 80 beds will be an addition to the already existing 90 beds in the existing facility, thus totaling to 200 beds across Asia. CMD Dr Shivprakash 46 Business: Provides clinical research services from phase I to phase IV Start-up Year: 1998 Address: The Chambers, 3rd Floor, Sarkhej-Gandhinagar Highway, Bodakdev, Ahmedabad - 380 054 Tel: +91-79-26853419, 26840427 Fax: +91-79-26853415 Website: www.synchronresearch.com Revenue: 63 crore* JK Agri Genetics JK Agri Genetics Limited (JKAL), an erstwhile division of JK Tyre & Industries, clocked a total turnover of 50.66 crore in 2010-11 when compared with the last year’s revenue of 32.50 crore. The company is focused on R&D, production, processing and marketing of hybrid seeds of sorghum, pearl millet, maize, cotton, rice, sunflower, tomato, okra and hot pepper. There are many hybrids marketed by the company, including fast-moving hybrids such as JK 99, JK Durga, JK 666, JK Indra, JK Varun (555), JK Chamundi. The firm has a team of 15 committed scientists working on different areas of biotechnology. JKAL is planning to diversify its research into medicinal and aromatic plants in core activities such as cultivation, contract farming, varietal development, quality extract production and chemical & DNA finger printing. JKAL is building up its R&D as well as marker-assisted selection with novel traits with the help of biotechnology tools. President Mr P S Dravid 47 Business: Involved in R&D and marketing of agri biotech products Start-up Year: 1989 Address: 1-20-177, 4th Floor, Varun Towers, Begumpet, Hyderabad-500016 Tel: +91-40-66316858 Fax: +91-40-27764943 Website: www.jkseeds.net Revenue: 50.66 crore* Wockhardt Wockhardt, the first company in Asia to launch its recombinant human insulin product, Wosulin, in 2003, recorded an estimated biotech revenue of 50 crore for 2010-11. In Feb 2011, Wockhardt entered into a strategic global alliance with Sheffield Bio-Science, a Kerry Group Business from the US, under which the latter will have exclusive sales and distribution rights to supply the recombinant insulin to the cell culture markets worldwide. Wockhardt announced in 2009 that it was experiencing liquidity crisis and was reportedly facing a debt burden of more than 3,000 crore. Following this, there were talks that the company would sell its biotech division. Companies like Pfizer and Sanofi Aventis were on the run to acquire this unit, and its valuations reached a whopping 250 crore. Presently, the firm’s R&D is based in Aurangabad & Mumbai; Negma Laboratories in France; Morton Grove Pharmaceuticals in Illinois, US; Pinewood, Ireland and in UK. Chairman Mr Habil F Khorakiwala 48 Business: Pharmaceutical and biotechnology business Start-up Year: 1960 Address: Wockhardt Towers, Bandra Kurala Complex, Bandra (East), Mumbai-400051 Tel: +91-22-26596258 Fax: +91-22-26596801 Website: www.wockhardt.in Revenue: 50 crore* Max Neeman International Max Neeman International, a subsidiary of the Max India Group, registered a growth of 21 percent from 40 crore in FY 2009-10 to 48.4 crore in FY 2010-11. The firm offers a full range of clinical research services with focus on phase I-IV trials for drugs, devices, nutraceuticals and cosmetics in compliance with ICH GCP standards. It is based out of six regional offices and has 175 active sites in 22 cities, with access to over 900 GCP trained investigators. Max Neeman is a ISO 9001:2008 and ISO 27001 certified organization. The number of trials of the firms reached 200 and the CRO has a total client base of 65 companies across the globe. Max Neeman has consistently maintained a patient retention rate of above 98 percent across multiple therapeutic areas for all its studies. Max Neeman successfully completed four FDA audits for the highest enrollment globally and has been successfully audited around 40 times by the sponsor companies. CEO Dr Ajoy Kumar 49 Business: Clinical research services Start-up Year: 2001 Address: Max House, 1 Dr Jha Marg, Okhla III, New Delhi-110020 Tel: +91-11-40772100 Fax: +91-11-28322846 Website: www.neeman-medical.com Revenue: 48.4 crore Clinigene International Clinigene International, the full service clinical research arm of biotech major, Biocon, registered a turnover of 43 crore in FY 2010-11 as compared to 39 crore in the FY 2009-10. In the year 2010, studies conducted by Clinigene were successfully audited by the USFDA and EMA without Form 483 or critical findings. In addition to the standard service platforms, the company has identified several more specialized areas, such as patient-based early studies, complex BA/BE studies and bio-analytical services, where customers are now seeking CRO support. The new areas of focus for Clinigene include biomarker development, data management and pharmacovigilance. Clinigene is India’s first CAP accredited central laboratory and has also received NABL accreditation. The company has evolved and adapted its capability platforms and service offerings against a background of continued macro market pressures. COO Dr Abhijit Barve 50 Business: Clinical research Start-up Year: 1996 Address: Clinigene House, Tower 1, Semicon Park, Electronic City, Phase II, Bangalore-560100 Tel: +91-80-28082808 Fax: +91-80-28083150 Website: www.clinigeneintl.com Revenue: 43 crore ]]> <![CDATA[Top 36-40]]> https://biospectrumindia.com/news/95/5085/top-36-40.html https://biospectrumindia.com/news/95/5085/top-36-40.html Thu, 09 Jun 2011 15:22:00 +0530 Span Diagnostics Span Diagnostics clocked an estimated revenue of 92.53 crore for FY 2010-2011, as against 78.98 crore for 2009-10. The company, which has been supplying to India’s national programmes for AIDS and malaria since the past eight years, achieved tender sales worth 28 crore from the Indian government during the past year. Span currently houses three businesses namely, the diagnostic reagent business, the instruments business and exports, and boasts of a joint venture with Japan-based, Nihon Kohden corporation. The company is looking to modernize its plant by investing 12 crore over a period of one-and-half years. The company expects to grow at a rate of 17 to 20 percent in 2011, following which, Span anticipates hitting a growth rate of 25 to 30 percent. This confidence is due to the launch of a number of products by 2012 along with an increase in export sales. Span is looking to achieve a turnover of 1,000 crore by 2020. Founder and Chairman Dr Pradip Desai 36 Business: Provider of diagnostic, instruments & clinical chemistry products Start-up Year: 1976 Address: 173- B ,New industrial Estate, Udhna, Surat – 394210, Gujarat Tel: +91-261-2277211 Fax: +91-261-2279319, 2665757 Website: www.span.co.in Revenue: 92.53 crore* Aventis Pharma Aventis Pharma clocked an estimated sales of 90 crore in FY 2010-11 when compared with 68.34 crore in FY 2009-10. The company has consolidated its position in the growing insulin market with its star product Lantus, which has a market share of 10.24 percent, showing a growth of nearly 30 percent. Other insulin brands including Amaryl and Apidra witnessed a growth of 29 percent and 100 percent respectively. During the FY, the company sold off its entire shareholding in the joint venture company, Chiron Behring Vaccines Private to Novartis Pharma for 100.7 crore. The company reduced the price for its monocomponent insulin, Lantus, by 2.8 percent as per the direction from the National Pharmaceutical Pricing Authority (NPPA) from 2,439.27 for a 10 ml vial of Lantus 100 IU/ml to 2,370.49. The company also has several community service initiatives like the SOS Children’s villages, Childline, the Akansha Foundation, Voluntary Health Association of Goa and the Joy of Giving. MD Dr Shailesh Ayyangar 37 Business: Marketing of biotech products Start-up Year: 1956 Address: Aventis House, 54/A, Sir Mathuradas, Vasanji Road, Andheri East, Mumbai-400093 Tel: +91-22-28278000    Fax: +91-22-28370939 Website: www.aventispharmaindia.com Revenue: 90 crore* Novartis Vaccines In the FY 2010-2011, the vaccine business of Novartis in India clocked 89.65 crore. In India, Novartis and Aventis Pharma had a 51:49 joint venture in Chiron Behring Vaccines, in which the former had marketing rights of the later’s anti-rabies vaccine, Rabipur, in India. However in December 2010, Aventis Pharma sold off its 49 percent stake in the joint venture to Novartis Vaccines and Diagnostics (NV&D) for around 100 crore. Novartis Vaccines and Diagnostics division ’s portfolio includes some prominent influenza and meningitis vaccines and travel vaccines. In the first half of 2010, the division globally completed the distribution of A(H1N1) vaccine. Now, work has started for developing pre-pandemic vaccines that would provide protection to the global population against possible future pandemics. Country Head, India Mr Masood Alam 38 Business: Healthcare, vaccines and diagnostics Start-up Year: 2006 Address: Novartis India Limited, Sandoz House, 8th floor, Shivsagar Estate, Dr Annie Besant Road, Worli, Mumbai - 400 018, India Tel: +91-22-24958804, 24951074 Fax: +91-22-2495 2624  Website: www.novartis.in Revenue: 89.65 crore* Ajeet Seeds Ajeet Seeds, a producer and processor of hybrid cottonseeds in India, generated a revenue of 87.5 crore in 2010-11. The company received approval from the Genetic Engineering Approval Committee (GEAC), Government of India, for the sale of Bollgard I (Ajeet 33, Ajeet 155, Ajeet 177), Ajeet 901 (HxB), ACH 21 (Arya 21 Bt) and Bollgard II (Ajeet-11, Ajeet 155, Ajeet 33), ACH 177 (Arya 177 BG II, Ajeet 111), ACH 5 (Arya 21 BG II) cotton hybrids in Central, South and North zones in 2006. The company has developed its own genetic resources of hybrid seeds in cotton, jowar, bajra, maize, chilli, okra and pigeon pea. The company has established a wide network of 400 distributors, 3,000 dealers and more than 30,000 seed growers all over India. The company is gearing up to launch its indigenous transgenics in okra & cotton that would offer resistance to biotic and abiotic stress. MD Mr Sameer Mulay 39 Business: Research, production, processing and marketing of hybrid seeds Start-up Year: 1986 Address: Tapadia Terraces, 2nd Floor, Adalat Rd, Aurangabad- 43100 Tel: +91-240-2333933   Fax: +91-240-2333335 Website: www.ajeetseed.co.in Revenue: 87.5 crore* Haffkine Bio-Pharmaceutical Corporation Haffkine Bio-Pharmaceutical Corporation (HBPCL) is engaged in the manufacture and supply of a wide range of products comprising bacterial and viral vaccines, antisera, toxoids injectables, disinfectants, ointments, injectables, syrups and mixtures. The firm clocked an annual sales revenue of 86 crore for 2010-11 against last year’s 168.98 crore. The firm’s total group turnover, comprising Haffkine Ajintha Pharmaceuticals and Antitoxin and Sera is over 100 crore. The Antitoxin and Sera (ATS) department of HBPCL is located at Pimpri, near Pune, and it is engaged in the manufacture of antiserum against tetanus, diphtheria, gas gangrene, snake and scorpion venoms. The ATS operates on 75 acres of land with a total strength of 400 equines. HBPCL has supplied oral polio vaccines to UNICEF and the Government of India. The company is also planning to build manufacturing facilities complying with the WHO’s GMP standards for DTP/pentavalent vaccine. MD Mr P R Sabde 40 Business: Production and supply of biopharmaceutical products Start-up Year: 1975 Address: Acharya Donde Marg, Parel, Mumbai - 400012 Tel: +91-22-24129320 Fax: +91-22-24168578 Website: www.vaccinehaffkine.org Revenue: 86 crore ]]> <![CDATA[Top 31-35]]> https://biospectrumindia.com/news/95/2405/top-31-35.html https://biospectrumindia.com/news/95/2405/top-31-35.html Thu, 09 Jun 2011 15:20:00 +0530 DiagnoSearch Life Sciences DiagnoSearch Life Sciences, formerly iGate Clinical Research, recorded revenues of 121 crore for 2010-11 as against previous year’s revenue of 97 crore. DiagnoSearch has passed over 100 CQA audits by North American and European biopharmaceutical companies and offers a complete range of phase I to IV clinical trials support services. Over the past 12 years, DiagnoSearch managed over 100 clinical trials for global sponsors in a broad range of therapeutic areas. The company has a headcount of more than 100 staff and is going to come up with a new 30,000 sq ft office facility. The firms mainly operates using three divisions, namely, clinical operations, monitoring and the project management division. The firm has a central laboratory that offers comprehensive solutions including, production of bar-coded, visit-specific kits, investigator team training, state-of-the-art analytical methods, efficient specimen shipment and automated data reporting. Founder and MD Dr Vasudeo Ginde 31 Business: Offering a complete range clinical trials support services Start-up Year: 1975 Address: 101, First Floor, B G House, Orchard Avenue, Hiranandani, Business Park, Mumbai-400076 Tel: +91-22-66976300 Fax: +91-22-66754090 Website: www.diagnosearch.com Revenue: 121 crore* Veeda Clinical Research Veeda Clinical Research, is a full service global CRO specializing in early clinical development of drugs (phase I and IIa) with state-of-the-art facilities in the UK, India and Belgium. It recorded revenues of 120 crore during the FY 2010-11 as against last year’s revenue of 112 crore, with a growth of about 7.14 percent. Veeda has been growing at a rate of 70 percent since its inception and aims to achieve a turnover of 325 crore in the next three years. The firm has acquired four CROs in Europe and presently houses state-of-the-art phase I facilities in Plymouth, UK; Ahmedabad, India and Görlitz, Germany. In October 2010, Veeda announced the opening of its facility at Ahmedabad, spread across three floors with an area of 25,000 sq ft. In May 2011, Veeda announced that the final steps have been put in place for the commissioning of its CRC Veeda (Malaysia) phase I unit in the Ampang Hospital in Kuala Lumpur, Malaysia. Founders & MDs Mr Apurva Shah & Mr Binoy Gardi 32 Business: Specializes in early clinical development Start-up Year: 2005 Address: Veeda Clinical Research – India, Shivalik Plaza-A, Near IIM, Ambawadi, Ahmedabad- 380015 Tel: +91-79-30013000    Fax: +91-79-30013010 Website: www.veedacr.com Revenue: 120 crore Intas Biopharmaceutical Intas Biopharmaceutical (IBPL) clocked revenue of 110 crore in FY 2010-11 as compared to 115 crore in the previous FY. Intas Pharmaceuticals, IBPL’s parent compnay has filed its red herring prospectus (DRHP) with SEBI and is looking to raise 425 crore. The firm has presently developed and commercialized five products in India and other semi-regulated markets in Africa, Latin America and Asia Pacific and has an additional 11 projects at advanced stages of development, out of which, nine projects are for the Indian market and two are for regulated markets. IBPL also intends to invest 15.33 crore at the Moraiya facility. The company launched bortezomib injection, under the brand name Borviz, which is expected to offer an effective treatment for multiple myeloma. The company will also invest 160 crore towards setting up a manufacturing facility at Sanand, near Ahmedabad, to produce monoclonal antibodies with a capacity of 5,000 liter in phases. CEO (MD) Dr Urmish Chudgar 33 Business: R&D, manufacturing & marketing of recombinant products and oncology drugs Start-up Year: 2006 Address: Plot No 423/P/A/GIDC, Moraiya, Sarkhej-Bavla highway, Tal: Sanand, Ahmedabad-382210 Tel: +91-2717-660101 Fax: +91-2717-251189 Website: www.intasbiopharma.co.in Revenue: 110 crore* Diagnova (A division of RFCL) Diagnova is the diagnostic division of RFCL, which is now part of US-based Avantor Performance Materials. In FY 2010-11, Diagnova recorded a sluggish growth with revenues of 103 crore as compared to 100 crore in the FY 2009-10. This firm’s manufacturing plant is situated in Dehradun, Uttarakhand, and the company offers quality products and services to over 6,000 customers. The business of Diagnova is divided into three strategic units: In Vitro Diagnostics (IVD), Medical Sciences Group (MSG) and Life Sciences Group (LSG). Diagnova has an ISO certified manufacturing setup for IVD products based at Haridwar, Uttaranchal. The MSG Group of Diagnova markets medical devices in the field of gastroenterology with a product profile that covers ph & motility systems, breath test analyzer, cardiac surveyor and surgical staplers among others. The LSG group offers solutions for the molecular biology segment and emerging areas like protein crystallography & drug discovery. MD Mr Sushil Mehta 34 Business: Diagnostics Start-up Year: 2005 Address: A-3, Okhla Industrial Area Phase-I, New Delhi-110 020 Tel: +91-11-42395700 Fax: +91-11-41609189 Website: www.rfcl.in/dignova, www.diagnova.in Revenue: 103 crore Vimta Labs Vimta Labs, one of India’s leading contract research and testing organization, reported a revenue of 96.5 crore in FY 2010-11 as compared to 88.42 crore in 2009-10. The company employs 756 personnel, including 479 scientists, and boasts of more than 300,000 sq ft of world class laboratory facilities. Vimta Labs achieved AAALAC International full accreditation in February, 2011, and the company conducts its operations in compliance with ICH-GCP and GLP. The company has a large bioanalytical group, equipped with 26 mass spectrometers across two sites, operational round the clock. Over 200 bioanalytical methods have been developed and validated at Vimta Labs and the firm conducted over 1,100 BA/BE studies on various dosage forms such as tablets, capsules, extended release preparations, gels, jelly’s, solutions, transdermal patches and injectibles among others. CMD Dr S P Vasireddi 35 Business: Contract research Start-up Year: 1984 Address: 142, IDA,Phase II, Cherlapally, Hyderabad-500 051 Tel: +91-40-27264141  Fax: +91-40-27263657 Website: www.vimta.com Revenue: 96.5 crore ]]> <![CDATA[Top 26-30]]> https://biospectrumindia.com/news/95/1968/top-26-30.html https://biospectrumindia.com/news/95/1968/top-26-30.html Thu, 09 Jun 2011 15:18:00 +0530 Advanced Enzyme Technologies Advanced Enzyme Technologies (AETL) clocked total sales revenue of 154 crore for FY 2010-11 as compared to 121 crore in 2009-10. The revenue is expected to increase 30 to 35 percent on a year-on-year basis for the next five to eight years. The company operates primarily in four segments, including human health & nutrition, animal nutrition, food processing, and industrial processing. The company is expected to start its European and Chinese subsidiaries soon. More than 50 percent of the company’s sales come from its exports to 53 countries. AETL, which had a overhaul in 2009, developed more than 400 unique enzyme products like luicine amino peptidase (exo-peptidase), candida antarctica lipase b immobilized, a full range of hemicellulase and pectinase enzymes and a full range of grain ethenol enzymes. AETL is also the largest manufacturer of serratiopeptidase, having perfected the art of manufacturing the enzyme over the past 15 years. CEO Dr CL Rathi 26 Business: Manufacturing, R&D and marketing of enzymes Start-up Year: 1989 Address: Sun Magnetica, “A” wing, 5th Floor, LIC Service Road, Louiswadi, Thane (W)- 400 604 Tel: +91-22-41703200 Fax: +91-22-25835159 Website: www.enzyme.com Revenue: 154 crore* Lambda Therapeutic Research Lambda Therapeutic Research recorded an estimated sales revenue of 128 crore for 2010-11. The company offers services such as clinical trials implementation, laboratory and data management, information technology support, medical affairs assistance, quality assurance and bio analysis. The CRO has more than 640 clinical beds globally, including a 16-bed phase I unit in Ahmedabad, a 12-bed phase I unit in Toronto, Canada, a six-bed phase I unit in Warsaw, Poland. The company also has more than 40 LC-MS/MS systems, a CAP/NGSP accredited clinical laboratory, molecular and microbiological laboratory and a low temperature (2-8 °C, -20 °C and -80 °C) controlled storage facility, to store over 4.0 million samples. Lambda Therapeutic Research has additional facilities in Mumbai, India and Erwitte, Germany and has acquired a pharmacovigilance CRO in UK, named Pharm V Solutions. MD Ms Bindi Chudgar 27 Business: Clinical trials implementation, laboratory and data management Start-up Year: 1999 Address: Near Gujarat High Court, S. G. Highway, Gota, Ahmedabad-380061 Tel: +91-79-40202020 Fax: +91-79-40202021 Website: www.lambda-cro.com Revenue: 128 crore* Concord Biotech Concord Biotech, a R&D-based company that focuses on fermentation and semi-synthetic based products, achieved a total income of 126.17 crore in FY 2010-11 as compared to 111.07 crore in the previous year. It is the largest producer of penicillin-G amidase enzyme, with a market share of 90 percent. It exports this enzyme to a number of companies in China, Europe and the US. Concord also produces and exports lovastatin and tacrolimus and is also starting the production of simvastatin and pravastatin in its new US-FDA approved facility. It now boasts of having one of the largest numbers of bioreactors in India and has setup a lyophilization facility for sterile bulk biopharmaceutical. It also has a manufacturing facility, spread across 28 acres of land, located at Ahmedabad, Gujarat. In FY2010-11, Concord initiated its CRAM business by setting up of its new R&D facility. The company received award for its outstanding contribution to the healthcare sector at Bangalore India Bio 2011. MD and CEO Mr Sudhir Vaid 28 Business: Manufacturing of bulk drugs Start-up Year: 2002 Address: 302, Sakar-III, Opp: Gujarat High Court, Off ITO Circle, Ashram Road, Ahmedabad-380014 Tel: +91-79-27544998, 27543557 Fax: +91-79-27540802 Website: www.concordbiotech.com Revenue: 126.17 crore Ecron Acunova Ecron Acunova is a Bangalore-based CRO with offices across India and operations in 14 European countries. The company recorded revenue worth 125 crore in the FY 2010-11 as compared to 97 crore in FY 2009-10. In January 2011, Ecron Acunova expanded its clinical research center for drug development by 80 beds. The company also announced a joint venture with Jamjuree Innovations(JJI), Thailand and will conduct clinical research in key South East Asian countries under the name, Ecron Acunova Company Limited (EACL). In April 2011, Ecron Acunova acquired a majority stake in aCROnordic, a Danish CRO specializing in clinical research in Sweden, Finland and Norway. Since its inception five years ago Ecron has conducted over 250 phase I one studies and over 70 late phase studies, which has helped the company reach the third position amongst nearly 100 CROs in India. Founder & Chairman Mr DA Prasanna 29 Business: Clinical research services Start-up Year: 1986 Address: Manipal Acunova Limited, Mobius Towers, SJR i-Park, EPIP, Whitefield, Bangalore-560066 Tel: +91-80-66915700 Fax: +91-80-66915719 Website: www.ecronacunova.com Revenue: 125 crore* Themis Medicare Themis Medicare (TML) achieved a total turnover of 124 crore as against 90 crore for the year ending March 31, 2010. TML has a plant located in Hyderabad where lovastatin, simvastatin and other fermentation-based actives are produced. TML boasts of four state-of-the-art manufacturing facilities at three locations, in Vapi (Gujarat), Hyderabad (Andhra Pradesh) and Haridwar (Uttaranchal). The company has a joint venture partnership with Gedeon Richter (Budapest, Hungary), named Richter-Themis Medicare (India) Private Limited and also has signed a long-term business agreement with Schering-Plough Animal Health Corporation, US (SPAH). Although its first breakthrough product was vitamin B12, TML moved on to manufacture several synthetic API and numerous therapeutics. MD and CEO Dr Dinesh Patel 30 Business: Formulations and API of synthetic origin Start-up Year: 1969 Address: 11/12, Udyog Nagar, S.V.Road, Goregaon (West), Mumbai-400 104 Tel: +91-22-67607080, 28757836 Fax: +91-22-28746621 Website: www.themismedicare.com Revenue: 124 crore* ]]> <![CDATA[Top 21-25]]> https://biospectrumindia.com/news/95/5672/top-21-25.html https://biospectrumindia.com/news/95/5672/top-21-25.html Thu, 09 Jun 2011 15:14:00 +0530 Siro Clinpharm SIRO Clinpharm Private Limited (SIRO), clocked an estimated sales revenue of 202 crore for FY 2010-11 when compared with 150 crore in 2009-10. During early 2011, the CRO announced the launch of its operations in Malaysia and also announced strategic alliances with CROs in South Korea and Taiwan in 2010. The company is in the process of evaluating Philippines and Thailand amongst other Asian countries for expanding its clinical operations. SIRO has strategic alliances and partnerships with several firms such as Clingene, Pfizer and with Fisher Clinical services. SIRO is a member of Bundesverband Medizinischer Auftragsinstitute, the German Federal Association of Contract Research Organizations. SIRO's laurels include, conducting over 130 clinical trails, recruiting over 20,000 clincial trial subjects, passing over 240 audits by sponsor QA teams and working on USFDA, EMEA, UK MHRA, Korean FDA WHO Health Canada and DCGI submissions. Founder & Chairman Dr Gautam Daftary 21 Business: Offers clinical Trials services Start-up Year: 1996 Address: DIL Premises, Ground Floor, Swami Vivekanand Rd, Near Tatwagyan Vidyapeeth, Ghodbhunder Rd, Thane (W)- 400607 Tel: +91-22-25848000 Fax: +91-22-25848475 Website: www.siroclinpharm.com Revenue: 202 crore* Cadila Healthcare Cadila Healthcare clocked biotech revenues worth 190.59 crore for FY 2010-11 as compared to the previous fiscal's revenue of 147.48 crore. Presently, the firm has 15 biosimilars and two novel products in its pipeline. The company is also looking at biobetters for the future growth and has dedicated 120 scientists for this purpose. Zydus Cadila acquired Italy-based, Etna Biotech, and the firm's Zydus Research Center (ZRC), has been working on strategic research collaboration with Prolong Pharmaceuticals, US, and Karo Bio, Sweden and Eli Lilly. Zydus Cadila has made swift progress on NME research and has 12 INDs in various stages of clinical trials and several more INDs in pre-clinical evaluation. The company also signed an agreement with Bayer HealthCare, in January 2011, to set up a joint venture company, Bayer Zydus Pharma, for the sales and marketing of pharmaceutical products in India. CEO Pankaj R Patel 22 Business: Biologics and diagnostics Start-up Year: 1995 Address: Cadila Healthcare Ltd., Zydus Tower, Satellite Cross Roads, Ahmedabad â€“ 380015,Gujarat, INDIA Tel: +91-79-26868100 Fax: +91-79-26862365 Website: www.zyduscadila.com Revenue: 190.59 crore* Tulip Group Tulip Group of companies clocked a total revenue of 185.63 crore for FY 2010-11 as against 182.48 crore in FY 2009-10. Revenues from domestic sales for FY 2010-11 were 128.23 crore, while the firm reported exports worth 57.40 crore. During the fiscal, the company made investments worth 89.25 crore, including 1.67 crore in R&D, 20.25 crore in infrastructure and 30.01 crore on manpower. The group has on its rolls a total staff of 1,033 people and consists of several individual companies such as Tulip Diagnostics, Microxpress, Orchid Biomedical Systems, Qualpro Diagnostics, Zephyr Biomedicals, Coral Clinical Systems, BioShields, Tulip Marketing, Crest Biosystems and Lilac Medicare. It also has marketing alliances with companies like Monobind, US; Orgentec, Germany and TOSOH, Japan. The company's products are distributed across 55 countries, it has a sales team of 325 personnel, has a customer base of over 15,000 and has 300 distributors. CEO Dr Dilip Tripathi 23 Business: Manufacture and marketing of in vitro Diagnostic reagents and kits Start-up Year: 1988 Address: Gitanjali, Tulip Block, Dr Antonio Do Rego Bagh, Alto Santacruz, Bambolim Complex Post Office, Goa - 403 202, INDIA Tel: (0832) 2458546-51 Fax: (0832) 2458544 Website: www.tulipgroup.com Revenue: 185.63 crore* GlaxoSmithKline Pharmaceuticals GlaxoSmithKline (GSK) Pharmaceuticals, an affiliate of GlaxoSmithKline Biologicals, headquartered in Rixensart, Belgium, clocked an estimated sales of 163 crore in 2010-11 as compared to 123.34 crore in 2009-10. Today, GSK has a market share of 20 percent in the total Indian private vaccine segment. Vaccines contributed to nine to 10 percent of its total sales in the current year and in the coming years the company is looking at a growth of around 15 percent from its vaccines product portfolio. GSK India has 14 vaccines in its product basket, including Boostrix (tetanus toxoid, reduced diphtheria toxoid and acellular pertussis vaccine, adsorbed) and Cervarix, (human papillomavirus vaccine (types 16 and 18)) among others. The company's vaccine facility in Nasik, Maharashtra, is expected to witness an overhaul of 100 crore in the next three years. The Nashik facility also accounts for half of GSK's annual manufacturing capacity for its lymphatic filariasis (LF) programme. CEO Dr Hasit Joshipura 24 Business: Sales of vaccines and biologicals Start-up Year: 2001 Address: Dr Annie Besant Road, Worli, Mumbai-40030 Tel: +91-22-24959205 Fax: +91-22-24914863 Website: www.gsk-india.com Revenue: 163 crore* Monsanto India Monsanto India clocked revenue sales of 161 crore in FY 2010-11 as against 142.4 crore in 2009-10. Monsanto has been selling Bt cotton hybrids in India for the last five years under Monsanto Holdings Private Limited (MHPL). MHPL is focused on marketing Paras cotton hybrid seeds with Bollgard and Bollgard Bt cotton technologies and Seminis vegetable hybrid seeds. It was estimated that the company sold about 18 lakh packets of Bollgard during the 2010 kharif season, which is an increase of two lakh as comapred to the same period in the last year. Monsanto has launched Project SHARE (Sustainable Harvest Agriculture, Resources, Environment), a sustainable yield initiative with an NGO called the Indian Society of Agribusiness Professionals (ISAP), to improve the socio-economic conditions of 10,000 small-marginal corn and cotton farmers in 1,100 villages in Andhra Pradesh, Maharashtra and Rajasthan within four years. Managing Director Mr Amitabh Jaipuria 25 Business: Production and sale of herbicides, hybrid seeds and pesticides Start-up Year: 1949 Address: Ahura Centre, 5th Floor, 96, Mahakali Caves Road, Andheri (East), Mumbai -400 093 Tel: +91-22-28246450 Fax: +91-22-26902121 Website: www.monsantoindia.com Revenue: 161 crore* ]]> <![CDATA[Rides on innovation to maintain steady growth]]> https://biospectrumindia.com/news/95/1520/rides-on-innovation-to-maintain-steady-growth.html https://biospectrumindia.com/news/95/1520/rides-on-innovation-to-maintain-steady-growth.html Thu, 09 Jun 2011 15:13:00 +0530 RANK 20 204 crore Eli Lilly CMD Sandeep Gupta Business Solutions in diabetes, oncology, osteoporosis and growth hormones Start-up Year: 1993 Address:   Plot No-92, Sector 32, Institutional Area, Gurgaon-122001 Tel: +91-124-2823000 Fax: +91-124-2823012 Website:www.lillyindia.co.in  Eli Lilly sustained a consistent growth in the past year and has doubled its Indian business operations during the last five years Eli Lilly, which established its Indian operations in 1993 as a joint venture with Ranbaxy Laboratories, clocked revenue of 204 crore for the year 2010. Since its divestiture in 2001, the company emerged as one of the most admired organizations in terms of its focus on scientific selling, unique bouquet of products and services, professional working environment and relentless focus on ethics and compliance. With the help of a well established marketing set up at Gurgaon, India, Lilly provides innovative answers to the needs of patients of diabetes, cancer, sepsis, osteoporosis, cardiovascular disorders and growth hormone deficiency. Lilly has won numerous accolades in the past. It was ranked among top 25 companies in the “Best Employers in India” survey by Hewitt Associates in 2003. Eli Lilly also made it to the top 10 “Best Companies to Work for in India” in Business Today-Mercer-TNS survey 2008. Lilly was was also ranked the 2nd best company to work for under ‘Biotech & Pharmaceutical’ category in 2008: survey by Great Places to Work Institute, US. Lilly has an unique distinction of being the only pharmaceutical company in this list. Lilly was also recognized for its work in the field of pharma ad biotechnology by the Delhi Government, which felicitated Lilly India with a special “Award for Excellence” in 2010. Lilly has seven products in its biotech stable, including Human Insulin (Huminsulin); human insulin analogues (Humalog), Human Growth Hormone (Humatrope), Teriparatide (Forteo); drotrecogin alfa (Xigris), reopro (Abciximab-monoclonal antibody) and exenatide (Byetta). Overall, the firm’s anti-diabetes’ product range contributes roughly 60 percent of the Lilly India revenue. In October, 2010, Eli Lilly and Company launched a cardiovascular product called Effient (Prasugrel) in India. Effient is an oral antiplatelet (OAP) agent that has been approved for patients with acute coronary syndrome (ACS), who have undergone angioplasty procedures. The company also launched Humalog KwikPen, a pre-filled pen that contains Humalog (Insulin Lispro, rDNA origin) brand of insulins in April 2010. Humalog KwikPen requires less force to administer the injection, provides users with a smoother injection experience and is conveniently lighter and shorter than other pre-filled pens. On the corporate social responsibility (CSR) front, the company continues to work on the global ‘Lilly MDR-TB Partnership’, which was first announced in 2003 to confront multidrug-resistant (MDR) tuberculosis. Since then, this unique public-private partnership, with a total expenditure of nearly $135 million, has mobilized 25 partners on the five continents to tackle the scourge of TB and multidrug-resistant (MDR) tuberculosis. The partnership has adopted a multi-pronged approach in India and works in close coordination with the National TB Control Program in India. ]]> <![CDATA[Jubilant looks ahead to robust sales growth]]> https://biospectrumindia.com/news/95/2125/jubilant-looks-ahead-to-robust-sales-growth.html https://biospectrumindia.com/news/95/2125/jubilant-looks-ahead-to-robust-sales-growth.html Thu, 09 Jun 2011 15:11:00 +0530 RANK 19 210 crore Jubilant Life Sciences MD Mr Shyam S Bhartia Business CRAMS, drug discovery and development services Start-up Year: 1978 Address: 1A, Sector 16A, Noida-201301 Tel: +91-120-2516601-11 Fax: +91-120-2516628-30 Website:www.jubl.com Jubiliant is expecting a huge positive turnaround in its growth on the back of its life science products, services and business Jubilant Life Sciences Limited (formerly Jubilant Organosys) is an integrated pharmaceutical industry player that provides custom research and manufacturing services (CRAMS) and drug discovery and development services to 60 countries. The firm boasts of 10 world-class manufacturing facilities and a team of around 5,700 personnel across the globe. In FY 2010-11 the company recorded revenue of 3,433 crore in its products’ business, fueled by a robust volume growth of 16 percent across all products. However, the growth in drug discovery and development solutions (DDDS) business remained muted. The business clocked only 210 crore for FY 2010-11 from the drug discovery and development services’ business, Jubilant reported a decrease of 15.76 percent as compared to 249.3 crore in FY 2009-10. The company attributed the decline to delays on boarding of new integrated programs from key customers, postponement of milestone payments and slowdown in clinical research business due to global pharma consolidation. The DDDS group within Jubilant constitutes three of its subsidiaries, Jubilant Biosys, Chemsys and Clinsys Clinical Research. The DDDS group leverages its capabilities in emerging markets for a global outcome thus accelerating global drug development efforts. The group employs over 1,000 highly skilled and experienced scientific and medical personnel spread across Bangalore and Noida in India, Europe and the US. Jubilant’s therapeutically aligned clinical development capabilities provide collaborators a seamless transition from preclinical, translational and early stage development. This is further augmented by Jubilant’s ability to provide global access to late stage development (phase II-IV) across Europe, US and India. Jubilant is highly optimistic regarding its future as its services’ business is likely to witness substantial turnaround in margins and sales growth due to on-boarding of new projects and strong order book for products. In August 2010, the company signed a long term contract, valued at $51 million, in its CRAMS business with a leading US life science company. Jubilant also signed a long term contract in its CRAMS business with another US-based firm in the same month, with the expected contract valued at $33 million for the initial term of four-and-a-half years. To focus completely on its life sciences business, the company changed its name from Jubilant Organosys to Jubilant Life Sciences in Oct 2010 and subsequently in Dec 2010, the company went for the demerger of its agri and performance polymers business. According to Mr Shyam S Bhartia, chairman & managing director and Mr Hari S Bhartia, co chairman & managing director, Jubilant Life Sciences, “In FY2012, we expect to deliver a robust sales growth and better margins across all the businesses on account of increased capacity utilization, commissioning of new plants, innovation led new launches and expansion of market geographies. ]]> <![CDATA[BSV seeks partners to enter regulated markets]]> https://biospectrumindia.com/news/95/8474/bsv-seeks-partners-to-enter-regulated-markets.html https://biospectrumindia.com/news/95/8474/bsv-seeks-partners-to-enter-regulated-markets.html Thu, 09 Jun 2011 15:10:00 +0530 RANK 18 226 crore Bharat Serums & Vaccines CMD Mr Bharat Daftary Business R&D, manufacturing and marketing of biologicals Start-up Year: 1971 Address:   Hoechst House, 16th Floor, Nariman Point, Mumbai-400021 Tel: +91-22-66560900 Fax: +91-22-66560901 Website:www.bharatserums.com Bharat Serums is extremely focussed on research and  has invested seven percent of its turnover in research and development in 2010-11 Bharat Serums and Vaccines (BSV) recorded total biotech revenues worth 226 crore for FY 2010-11 as compared to 175 crore in 2009-10. The company manufactures and markets biological, pharmaceutical and biotechnology products and has a portfolio of over 25 brands, including plasma derivatives, monoclonals, equine antitoxins and serums cardiovascular, antimicrobials, antifungals, anaesthetics and hormones. Over the years, BSV has put a lot of emphasis on its R&D operations, both in India and overseas. BSV has also undertaken significant R&D activities with focus on biopharmaceuticals, novel drug delivery systems and equine products. The company invested around seven percent of its turnover in R&D, which is at par with international firm’s R&D expenditure. The research activities of the company have been recognized by the Department of Scientific and Industrial Research, Government of India. BSV holds a significant market share in India for plasma derivatives. The product portfolio of the firm includes Tetglob (human tetanus hyper immune globulin, Vinobulin (anti-Rho immuneglobulin gamma IV), Bharglob (intravenous immune serum globulin), Histoglob (histamine plus normal serum immunglobulin), Rhoclone (anti Rho-D immunoglobulin injection), equine antitoxins/antisera ASVS-Asia (polyvalent snake antitoxin – Asia), ASVS-Africa, polyvalent snake antitoxin – Africa equirab, rabies immunoserum 1000 I U, AGGS, mixed gas gangerene antitoxin and thymogam anti-thymocyte globulin. BSV is targeting the regulated markets for its products through technology licensing, in order to secure growth in the future. Since the company has quite a few potential products in its portfolio, it is now looking for alliances with partners for marketing and distribution of similar products. By following this model of business alliances and strategic partnerships, it can significantly reduce the time required to commercialize these products globally. BSV is presently looking for partners who can complement its product development skills with the expertise and resources in getting the products registered in regulated markets. In April 2010, Piramal Healthcare Limited, acquired BSV’s injectible anaesthetic products business. The former signed a definitive agreement to acquire Bharat Serum’s injectible anaesthetic products business including, Propofol, bupivacaine and atracurium besylate. The acquisition provides Piramal an immediate entry into the Propofol market, the world’s largest selling injectible anaesthetic. As per IMS, the total market size of Propofol is approximately $825 million. The market for the product excluding the European, US and Japanese region is approximately $250 million. BSV also received funding from Malaysian investment firm, OrbiMed, which would help facilitate the next stage of growth. Recently, BSV entered into a licensing agreement with a large European company for an anti-infective product. BSV is in exploratory discussions with pharmaceutical companies for collaboration in commercializing Docetaxel in markets throughout the world. ]]> <![CDATA[Shan5 product recall hits Shantha's revenue by 19%]]> https://biospectrumindia.com/news/95/3002/shan5-product-recall-hits-shanthas-revenue-by-19.html https://biospectrumindia.com/news/95/3002/shan5-product-recall-hits-shanthas-revenue-by-19.html Thu, 09 Jun 2011 15:07:00 +0530 RANK 16 272 crore* Shantha Biotech MD Dr KI Varaprasad Reddy Business R&D and manufacture of human therapeutics Start-up Year: 1993 Address:  H.No.5-10-173, 3rd & 4th Floors, Vasantha Chambers, Fateh Maidan Road, Basheerbagh, Hyderabad - 500 004. Tel: +91 40 23234136 Fax: +91 40 2323410 Website: www.shanthabiotech.com   Shantha Biotech is undeterred by the setback faced on account of its Shan5 vaccine and is gearing to launch four new vaccines between 2011-16 Shantha Biotech, the first Indian company to launch an r-DNA vaccine in 1997, witnessed a considerable 19 percent drop in its revenue — from 334.23 crore in 2009-10 to 272 crore in 2010-11. The drop in revenue is mainly because Shantha Biotech recalled its five-in-one vaccine, Shan5, from across the global markets following emergence of safety concerns. The WHO, which was procuring the Shan5 vaccine from Shantha Biotech under a long-time contract worth $340 million, called for recall and destruction of all the batches of the vaccine after a “white sediment” was discovered in some of the vials. Shantha Biotech supplied 24 million doses of Shan5 vaccines between November 2008 and February 2010. However, it is difficult to ascertain how much portion of this supply has been used. The cost of the 24 million vaccines would be around $72 million, assuming that the WHO pays $3 for a single dose of vaccine. The WHO, in its July 28, 2010, statement noted that it will maintain the tetanus toxoid, Shan TT, and hepatitis B vaccine, Shanvac, on the list of its prequalified products. Also, the prequalification for evaluation of cholera vaccine, Shancol, will continue. Since the potential root cause of the appearance of the sediment is linked with the manufacture of the pertussis component, the WHO has decided to remove the tetravalent vaccine (DTwP-hepatitis B) from the list of prequalified products. The Who has also decided to terminate the ongoing prequalification evaluation process for a DtwP vaccine, Shantrip. Shantha Biotech, 80 percent of which is now owned by Sanofi Aventis, is one of the leading players in the field of modern biotechnology in India. Since the development of the recombinant hepatitis B vaccine, the company has launched a tetravalent DPT hepatitis vaccine and has also commercialized three therapeutic proteins, including interferon alpha 2b, streptokinase and erythropoietin. Along with its subsidiary, Shantha West at San Diego, Shantha Biotech is engaged in the development of monoclonal antibodies using the human body’s own defense mechanisms. Realizing the potential of collaborative research, the company established collaborations with leading institutes like the Center for Cellular and Molecular Biology, the Indian Institute of Sciences and the International Vaccine Institute, Korea. Vaccines, therapeutic proteins and therapeutic monoclonals are the main focus areas of the firm for R&D in the product segment. Channeling almost 25 percent of its revenue into research, equipped with 50,000 sq ft of laboratory area and  having facilities for animal cell culture, hybridoma technology, virus handling, and upstream and downstream process development, Shantha Biotech boasts of state-of-the-art R&D infrastructure to engage in research of infectious diseases and oncology. The company has four vaccines, including a typhoid vaccine, a measles-rubella vaccine, a rotavirus vaccine and an HPV vaccine, in its product pipeline for the period of 2011-16. ]]> <![CDATA[Krishidhan expands footprint in Europe]]> https://biospectrumindia.com/news/95/4032/krishidhan-expands-footprint-in-europe.html https://biospectrumindia.com/news/95/4032/krishidhan-expands-footprint-in-europe.html Thu, 09 Jun 2011 15:03:00 +0530 RANK 15 276.13 crore Krishidhan Seeds MD Mr Sushil Karwa Business Production and distribution of hybrid seeds Start-up Year: 1996 Address: Krishidhan Bhavan, D3-D6, Additional MIDC Area, Aurangabad Road, Jalna-431203 Tel: +91-2482-222750 Fax: +91-2482-222600 Website:www.krishidhanseeds.com  During early 2010, KSL announced the opening of its first European subsidiary under the name of Krishidhan Seeds Europe, with HQ at Enkhuizen, Holland Krishidhan Seeds Limited (KSL) clocked biotech revenue of 276.13 crore for FY 2010-11 as compared to 133.23 crore in the previous year. The company’s revenue increased significantly because it was able to sell more Bt cotton seeds to farmers during the last year. The company made considerable progress in biotechnology in terms of offering the best solutions to farmers by providing Bt cotton seeds from 2007-08. The company develops, produces and distributes proprietary hybrid seeds to Indian farmers. Krishidhan Seeds was founded in the early 1980s and in 1996 got incorporated with Mr Sushil Karwa taking charge as its managing director. Today, the company has a pan India presence and has a product portfolio of more than 120 products to offer to farmers including field crops, vegetable seeds and crop nutrition. Some of the prominent products of the company include cotton BG I & BG II, soyabean, paddy, maize, wheat, sunflower, pearl millet, sorghum, pulses. It has a strong presence in 15 states with over 1,300 distributors in the country. The company today has a headcount of 250 marketing professionals and has a registered office in Indore (Madhya Pradesh), corporate office in Pune and the operational office spread across 16 acres in Jalna. Having consolidated its position in the domestic market, KSL took the leap last year in extending its footing to international markets. During early 2010, KSL announced the opening of its first European subsidiary under the name of Krishidhan Seeds Europe BV, with headquarters at Enkhuizen, Holland. Mr J H A Tamboer was appointed as the CEO of the subsidary. In April 2011, Krishidhan Seeds Europe B V and Axia Vegetable Seeds BV (a new venture of Sandor van Vliet) announced that they had entered into a strategic alliance agreement in the field of breeding, seed technology and sales. The new alliance will enable Krishidhan Seeds Europe to access the top European vegetable seed industry as well as large growers of produce. In India, the company has been investing heavily in R&D activities. During FY 2010-11, KSL invested a total amount of 2.3 crore in R&D and also invested around 8 crore in developing its infrastructure. The company today has 10 regional research stations in India and a state-of-the-art research center at Jalna, Aurangabad. It has a significant size of products, based on its own R&D and has successfully harnessed biotechnology to develop products using both GMO & non-GMO approaches.  The R&D units of KSL and its subsidiaries (Krishidhan Research Foundation, Krishidhan Vegetable Seeds and Subhash Fertilizers) have been recognized by the Department of Scientific and Industrial Research(DSIR), Government of India. KSL is managed by a board comprising 12 directors. Under the expert guidance and supervision of these top managers, a group of committed, highly qualified, experienced professionals continuously carry out innovation in every field of activity like research, production, processing, quality assurance and marketing. ]]> <![CDATA[Aim: Affordable immunity for animals, humans]]> https://biospectrumindia.com/news/95/1664/aim-affordable-immunity-for-animals-humans.html https://biospectrumindia.com/news/95/1664/aim-affordable-immunity-for-animals-humans.html Thu, 09 Jun 2011 15:02:00 +0530 RANK 14 283 crore Indian Immunologicals MD Mr KV Balasubramaniam Business Animal and human biologicals manufacturer Start-up Year: 1983 Address: Road # 44, Jubilee Hills, Hyderabad – 500033, Tel: +91-40-23544585 Fax: +91-40-23544007 Website: www.indimmune.com The company also has a R&D center in India that conducts research in rabies, hepatitis b and measles among others Clocking an estimated revenue of 283 crore, Indian Immunologicals has shown improvement from 2009-10 revenue of 272.87 crore. With an aim to make immunity affordable to both animal and humans alike, Indian Immunologicals, has grown to be one of the largest biologicals company in India since its inception in 1983. In 2010, the company introduced Folyson, a dairy cattle hormone, which indirectly enhances the milk production capacity of a dairy cow or buffalo. Furthermore, motivated by the success of the foot and mouth disease vaccine, Raksha, the company went on to launch its tissue culture vaccine, Raksharab, and also successfully produced and marketed its human anti-rabies vaccine, called Abhayrab. With a 213-acre complex in Hyderabad, which has the distinction of being WHO-GMP and ISO-9002 certified, Indian Immunologicals has one of the world’s largest veterinary vaccine plants in the world, equipped with state-of-the-art technology to manufacture and market vaccines to the masses. In the animal health sector, Indian Immunologicals manufactures vaccines for foot and mouth diseases, clostridium perfringens, sheep pox, brucella abortus, theileriosis and bacillus anthracis among others. It is also actively engaged in the production of other animal health products. In the human health sector, Indian Immunologicals has made a significant progress through its cell culture rabies vaccine, Abhayrab. This vaccine is sold by Abhay Clinics, which belong to the marketing network of Indian Immunologicals. The success of this anti-rabies vaccine has influenced the company to venture deeper into this domain by establishing two manufacturing facilities, one in Ooty and another in Hyderabad, India. The manufacturing facility of the company that is located in Hyderabad is equipped to produce vaccines such as  hepatitis-b, diphtheria, pertussis, tetanus and measles. The company has another R&D center in India that conducts research in rabies, hepatitis b and measles among others. The company’s marketing network is widespread with over 19 marketing outlets spread across India. In addition to the domestic network, the company also has significant export connections, supplying animal health vaccines to over 20 countries apart from the Food and Agriculture Organization (FAO) of the US. More than 12 countries across the world are receivers of Indian Immunologicals’ human anti-rabies vaccine, Abhayrab. The export market of the company is extremely diversified. It is spread across several countries including, the Gulf, Asia, Africa, Europe, Russia and other CIS nations. The company has research collaborations with several renowned institutions like Thomas Jefferson Medical School, Onderstepoort Veterinary Institute and Institute of Animal Health among others. Indian Immunologicals aims to combat infectious diseases in animals and human beings by producing affordable products for the betterment of mankind. ]]> <![CDATA[Syngene battles market pressure, grows 26%]]> https://biospectrumindia.com/news/95/2437/syngene-battles-market-pressure-grows-26.html https://biospectrumindia.com/news/95/2437/syngene-battles-market-pressure-grows-26.html Thu, 09 Jun 2011 14:59:00 +0530 RANK 12 318 crore Syngene International Director Mr Peter Bains Business Custom research and manufacturing of biopharmaceuticals Start-up Year: 1994 Biocon Park, Plot No. 2-3, Bomasandra IV phase, Jigini link road, Bangalore-560099 Tel: +91-80-28082808 Fax: +91-80-28083150 Website: www.syngeneintl.com Syngene's highly competitive discovery platform and the growth of long term R&D collaboration with Bristol Myers Squibb has yielded in the firm's growth Syngene International, a subsidiary of Biocon, is an internationally reputed custom research company with multi-disciplinary skills in synthetic chemistry and molecular biology. The company has posted another strong year of financial performance, delivering topline growth of 26 percent. The company reported sales revenue of 318 crore in FY 2010-11 as compared to 252 crore in FY 2009-10. These results are all the more encouraging for the company when set against the background of macro market pressures such as reduction in the global R&D expenditure and consolidation of market players. Key drivers of this growth have been Syngene's highly competitive platform in discovery chemistry, where they have strong customer retention; accelerating new customer traction; and the growth of Syngene's long term discovery and development collaboration with Bristol Myers Squibb, where Syngene is contributing over 400 scientists. Syngene's pioneering platform in biologics has supported discovery and development in the fast growing monoclonal antibody and protein therapeutics arena. According to Mr Peter Bains, director, Syngene International, much of the growth is coming from programs where its clients are utilizing Syngene's discovery and development platforms together in discreet integrated programs and where Syngene is able to make higher, value contributions to its clients work. Syngene conducts high value research in early stage drug discovery and development for a diverse range of global clients. From early stage discovery and process development to cGMP manufacturing, Syngene provides customized R&D services to pharmaceutical and biotechnology companies on a strong platform of confidentiality and intellectual property protection. Established in 1994, Syngene was India's CRO to receive special export status from the Government of India. Over the past 16 years, the company has successfully partnered with leading players in the global pharma industry across a range of challenging programs. During 2007, the company entered into a research partnership with Bristol-Myers Squibb (BMS). With the help of this partnership, Syngene is providing R&D services for discovery and early drug development to BMS. In 2008, Syngene International partnered with Sapient Discovery, a US-based biotech company, offering fully-integrated drug discovery services. â€œThe changing dynamics of the global pharmaceutical industry makes a compelling case for risk and cost mitigation strategies that rely on outsourced R&D services. Data already indicates that 21 percent of global R&D spends in 2009 were outsourced which was less than one percent a decade ago. This trend augers well for Syngene, which sees itself as a key player in this space with the potential of building niche capabilities for global leadership,â€? says Ms Kiran Mazumdar-Shaw, CMD of Biocon, the parent company. ]]> <![CDATA[Creates Bt cotton sales record]]> https://biospectrumindia.com/news/95/1513/creates-bt-cotton-sales-record.html https://biospectrumindia.com/news/95/1513/creates-bt-cotton-sales-record.html Thu, 09 Jun 2011 14:57:00 +0530 RANK 11 325 crore Ankur Seeds MD Mr MG Shembekar Business Agri-business in field crops, vegetables & transgenic crops (cotton) Start-up Year: 1976 Address: 27, New Cotton Market Layout, Nagpur - 440018 Tel: +91-712-2726148; 2725117 Fax: +91-712-2723455 Website: www.ankurseeds.com The company sold 15 lakh packets of BG-I and 9.50 lakh packets of BG-II in almost all the cotton growing states of India during the fiscal. Ankur Seeds Private Limited, a forerunner in marketing of insect resistant cotton hybrids in the country, increased its market share in Bt cotton substantially. The total revenue of Ankur Seeds for FY 2010-11 was 325 crore. The company sold 15 lakh packets of BG-I and 9.50 lakh packets of BG-II in almost all the cotton growing states of India during the fiscal. For distribution of its products, the firm has a well spread marketing network in 16 states of the country, head office in Nagpur, 11 regional offices and six area offices. The company organizes several regional demonstrations across the country which is attended by 100,000 farmers every year. The company has organized seven regional demonstrations in the previous year and invited over 50,000 farmers to its programs. It started its research activities in cotton, okra, brinjal and chillies and has expanded to more than 15 crops. The R&D of the company is recognized by the Department of Scientific & Industrial Research (DSIR) and the company also received the National Award for excellent R&D achievement from Government of India in 1996. Ankur Seeds has production and processing facilities spread across the various potential production areas of the country. The company has 11 state-of-the-art processing plants, with production capacity of over 16,000 tons; a dehumidified storage capacity of 5,000 sq m for medium term storage and 10,000 sq m of warehouses. Its products like Akka-Bt, Jai-Bt in cotton; Sonam & Rupali in paddy; Ankur 40 in okra; Ankur 32 in chilly; tomato 1001; Ajay, Kirti, Utkarsh in brinjal; Latika in ridge gourd; Shreya and Karishma in bitter gourd have become extremely popular with the farmers. In the year 2010-11, Ankur Seeds applied for registration of 14 varieties in PPV and FRA and it also released more than 20 varieties of commercial crops. Ankur Seeds has invested significantly in marker-assisted breeding projects for developing drought and disease resistant varieties in vegetable and rice. To achieve this it has collaborated with national and international institutes. Screening of drought resistant cotton transgenics is under process as per the guidelines of DBT and will also apply for the event selection trials for Bt brinjal that has been developed by the company. In brinjal, the company has successfully developed cytoplasmic genetic male sterility, which will have long term benefits in hybrid seed production technology in brinjal. The company has also procured a gene for insect resistance from the Indian Agricultural Research Institute in 2009, work on which is presently underway. Ankur Seeds also signed a memorandum of understanding (MoU) with the International Centre for Genetic Engineering & Biotechnology to work on a research project on development of virus resistance in okra. ]]> <![CDATA[Transasia expands into international markets]]> https://biospectrumindia.com/news/95/7585/transasia-expands-into-international-markets.html https://biospectrumindia.com/news/95/7585/transasia-expands-into-international-markets.html Thu, 09 Jun 2011 14:55:00 +0530 RANK 10 350 crore Transasia Bio-Medicals CEO Mr Suresh Vazirani Business Manufacturer and exporter of diagnostic instruments Start-up Year: 1979 Address: Transasia House, 8 Chandivali Studio Road, Mumbai - 400072 Tel: +91-22-40309000 Fax: +91-22-28573030 Website: www.transasia.co.in Transasia continues its run in the international markets. The company entered the US, Italy and Turkish markets in FY 2010-11 Mumbai-based Transasia Bio-Medicals Limited, a manufacturer and exporter of diagnostic instruments in India, witnessed a growth of 88 percent in 2010-11 by generating total sales revenue of 350 crore as compared to 186 crore in 2009-10. Transasia has acquired 40 percent market in the haematology segment and is looking to enlarge its market share in several segments including oncology, diabetes, cardiovascular and infectious diseases. The company has a 32-year track record in the industry and has successfully developed and manufactured hi-tech in vitro diagnostic (IVD) instruments and reagents. Started in 1979 as a marketing firm for a few imported diagnostic equipments, Transasia today has over 30,000 installations, supported by a network of 65 service centers and zonal offices spread across all the major cities. Fiscal 2010-2011, saw some eye-catching developments within the company’s strategy, both in terms of market expansion and increase in its product basket. Says Mr Suresh Vazirani, CMD, Transasia Bio-Medicals, “We have expanded into international markets, where there is a potential for growth. We have made an entry in the US, Italy and Turkish market this year, after our entry in Czech Republic and Russia in the last year.” In order to boost its product basket, Transasia is looking at striking alliances with leading diagnostic companies in the world. Today, it has three manufacturing facilities in India, one each in Germany, Czech Republic, Italy and US. On Jan 14, 2011, Erba Diagnostics Mannheim GmbH, a 100 percent Germany-based subsidiary of Transasia, acquired a 100 percent stake in Diasis Diagnostik Sistemler Ticaret Ve Sanayi A S, Istanbul, Turkey. Diasis is an ISO 9001/2000 and ISO 13485/2003 certified company that is involved in the development, production and marketing of products for IVD in the field of biochemistry, haematology and urine analysis. Transasia, with the help of Erba Diagnostics, also acquired a majority stake in a US-based IVD company, Ivax Diagnostics. Ivax is a fully integrated in vitro diagnostics company that develops, manufactures and distributes proprietary diagnostic reagents, test kits and instrumentation for autoimmune and infectious diseases, in the US and  other international markets. Transasia also has an alliance called the Sysmex Network Communication System (SNCS), an internet based online customer service launched in colloboration with Sysmex. The company now has major expansion plans up its sleeve. “If the IVD market continues to grow at 12-15 percent, we are looking at a growth rate of 30-40 percent year-on-year. We will see five-to-10 product launches this year in 2011,” says Dr Gurumukh Advani, president, sales and marketing. While small labs and government labs have been the main focus until date, the company is now looking at extending its products to corporate hospitals, CROs and chain laboratories. The company is also looking to scale up its infrastructure in several locations in India, including Mumbai, Baddi (Himachal Pradesh) and Daman. ]]> <![CDATA[Mahyco rides on a strong R&D program]]> https://biospectrumindia.com/news/95/2751/mahyco-rides-on-a-strong-rd-program.html https://biospectrumindia.com/news/95/2751/mahyco-rides-on-a-strong-rd-program.html Thu, 09 Jun 2011 14:54:00 +0530 RANK 9 364.9 crore* Maharashtra Hybrid Seed Company (Mahyco) Founder & Chairman Dr B R Barwale Business Solutions for GM crop testing Start-up Year: 1964 Address: PO Box 76, Jalna, Aurangabad Rd, Dawalwadi, Dist.- Jalna, Maharastra- 431203 Tel: +91-2482-233881, 233882 Fax: +91-2482-262002 Website: www.mahyco.com Diverse and progressive research in seeds has helped Mahyco sustain its growth in the biotechnology space Maharashtra Hybrid Seeds Company Limited (Mahyco) is engaged in R&D, production, processing and marketing of 200 products in 35 crop species, including cereals, oilseeds, fibre crops and vegetables. Mahyco recorded biotech revenue of 364.9 crore in 2010-11 as compared to 312 crore in 2009-10. The continuous growth in the sale of Bt cotton seeds, since its launch in 2002, has helped the company to continue to grow in the biotechnology space. Mahyco is credited with 21 notified research varieties of seeds and caters to the needs more than 100,000 farmers. It has 27 production centers and has a million seed processing capacity at eight processing plants and more than 9,000 tonnes of dehumidified storage for sensitive seed material. The production and the processing network are supported by a well developed all-India marketing network, consisting of more than 5,000 sales outlets. The cornerstone of Mahyco’s success has been a strong, diverse and progressive R&D program. Mahyco was the first company in the world to successfully commercialize F1 hybrid cotton, based on genetic and cytoplasmic male sterility system. Mahyco was also the first company in India to produce and market, hybrid sorghum, pearl millet and sunflower and the first company to receive the Government of India’s approval in 2002 for commercialization of insect-tolerant Bt cotton (Bollgard) followed by a superior Bt cotton (Bollgard II) in 2006. The company has a state-of-the art R&D center at Dawalwadi near Jalna, Maharashtra, where hybrid breeding programs are presenlty on-going in over 30 crop species and support program in plant pathology, entomology, cytogenetics, biochemistry, tissue culture, rapid cycling, biotech and transgenic plant research are also being carried out. Mahyco also has five more research centers and 18 multi-locational crop performance testing centers distributed across the country. Over 200 scientists are engaged in the research programs at Mahyco. The research focus at Mahyco Research Center has been in the areas of biotic and abiotic stress tolerance. The company was involved in pigeon pea and pearl millet breeding program with ICRISAT for over a decade and has also joined the Hybrid Rice Development Consortium, established by IRRI. Mahyco also shared Bt brinjal technology with public sector institutions in India and abroad, including UAS, Dharwad; TNAU, Coimbatore; IIVR, Varanasi; BARI, Bangaladesh; and UPLB, Philipines. Mahyco has participated in a number of projects under the aegis of the Department of Biotechnology (DBT), Government of India, and has entered into numerous partnerships with public institutions and private companies to bring the best technologies to Indian farmers. To name a few, Mahyco is sourcing sucking pest tolerance genes from the Bose Institute, Kolkata and chickpea pod borer resistance genes from Assam Agricultural University (AAU), Jorhat. ]]> <![CDATA[Continues to lead the India insulin market]]> https://biospectrumindia.com/news/95/5826/continues-to-lead-the-india-insulin-market.html https://biospectrumindia.com/news/95/5826/continues-to-lead-the-india-insulin-market.html Thu, 09 Jun 2011 14:50:00 +0530 RANK 7 462 crore* Novo Nordisk MD Mr Melvin Oscar D' Souza Business Diabetes care, growth hormone and homeostasis maintenance products Start-up Year: 1990 Address: Plot No.32, 47-50, EPIP Area, Whiltefield, Bangalore - 560 066 Tel: +91-80-40303200 Fax: +91-80-41123518 Website: www.novonordisk.co.in Novo Nordisk, one of the largest companies in the world in diabetes care, presently accounts for 55 percent of the insulin market in India The growth of the insulin market in India helped Novo Nordisk register a growth of 27.62 percent with sales revenue touching 462 crore in FY 2010-11 as compared to previous year's revenue of 362 crore. Novo Nordisk India, which is synonymous with diabetes care in India, continues to lead the insulin market with over 55 percent of the market share. Established in the year 1990, Novo Nordisk India is a subsidiary of Novo Nordisk, one of the largest companies in the world leading in the domain of diabetes care products. It claims to be introducing products and services that have never before been seen in the treatment of diabetes in India. With products in diabetes care, homeostasis management and hormone replacement therapy, Novo Nordisk, has since the last decade tried to change the way people live, when they are struck by these unfortunate but alarmingly common diseases. Novo Nordisk is seeking to change the future course of diabetes by using innovation to produce novel methods of diagnosis and treatment for diabetes. Novo Nordisk has already produced an array of products that could be used to treat and monitor diabetes. To help treat diabetic patients, Novo Nordisk has come up with a range of biopharmaceuticals like modern insulin, NovoNorm and Glucagen Hypokit. Apart from biopharmaceuticals, the company also introduced insulin delivery devices like durable pen and prefilled pen. The company boasts of revolutionizing treatment of diabetes with the introduction of the dial-insert-push technology of insulin delivery. Homeostasis management, which is one of the areas of focus for Novo Nordisk, has influenced the company to produce a recombinant factor VIIa, NovoSeven, for the treatment of hemophilia A and B, an essential product for patients whose blood fails to coagulate at the appropriate moment. Another area of focus for the company is growth hormone therapy. Novo Nordisk has produced devices to help patients suffering from growth hormone deficiencies like Turner's syndrome and chronic renal disease with the help of their products like Norditropin Nordilet. Novo Nordisk says it will to help the people who are suffering from diabetes. In this regard the company has established and maintained partnerships with external organizations. As a part of its global initiatives, the company launched Diabetes Awareness Wishes and Needs (DAWN), programme in India. The programme is based on the largest global survey of the psychosocial aspects of diabetes until date. It involves more than 5,000 diabetic people and 3,800 healthcare professionals in 13 countries. It is a global Novo Nordisk initiative in collaboration with the International Diabetes Federation and an expert advisory panel. Today, the initiative conducts activities in more than 30 countries. ]]> <![CDATA[Reliance Life Sciences rides on biosimilar wave]]> https://biospectrumindia.com/news/95/2403/reliance-life-sciences-rides-on-biosimilar-wave.html https://biospectrumindia.com/news/95/2403/reliance-life-sciences-rides-on-biosimilar-wave.html Thu, 09 Jun 2011 14:27:00 +0530 RANK 5 490 crore Reliance Life Sciences President & CEO Mr K V Subramaniam Business Research initiatives in medical, plant and industrial biotechnology Start-up Year: 2002 Address: Dhirubhai Ambani Life Sciences Center, R-282, TTC Industrial Area of MIDC, Thane-Belapur Road, Rabale, Navi Mumbai-400701 Tel: +91-22-67678000 Fax: +91-22-67678099 Website: www.rellife.com RLS is all set to establish itself as the leader in the Indian biosimilars' sector. It has an exhaustive biosimilars' pipeline and would launch two products in 2011 Reliance Life Sciences (RLS) is a research-driven biotechnology-led life sciences organization that is part of Mukesh Ambani's Reliance Industries. The firm clocked an annual sales revenue of 490 crore in 2010-11 as compared to 450 crore in 2009-10. Founded in 2002, RLS operates in medical, plant and industrial biotechnology avenues. RLS has the largest pipeline of biosimilars and markets five biosimilar products in India, including ReliFeron, ReliPoietin, ReliGrast, MIRel and FostiRel. RLS is planning to launch two biosimilars in the Indian market during 2011 and is also looking to increase its manufacturing capacity, product and market volumes. RLS's UK-based subsidiary, Reliance GeneMedix, is focusing on developing and marketing biosimilars in the European markets. Reliance GeneMedix Ireland's EPO product, Epostim, is currently in its clinical programme and the company is running validation programmes for regulatory submissions. Apart from biosimilars, RLS also develops and markets (both in India and overseas), five plasma protein products namely ReliSeal, AlbuRel, ImmunoRel HemoRel and ReliPlasma. In novel proteins' discovery, RLS made progress in its siRNA and fusion proteins' programs for anti-cancer and anti-viral indications and expects to move them into pre-clinical development in 2011. In the specialty pharmaceutical business, RLS launched two APIs in India and in semi-regulated markets. The company had two DMFs filed for for matinib and capecitabine in US. RLS expanded its API manufacturing facility and commissioned a new oncology formulations facility. RLS plans to further strengthen its specialty pharmaceuticals portfolio in 2011 with additional APIs and formulated products, apart from filing ANDAs for two oncology products. In the regenerative medicine area, RLS expanded its cord blood banking business and introduced a stem cell therapy for conjunctival disorders, apart from progressing clinical trials for stem cell therapies in neurology and wound management. Throwing light on the company's game plan in the global landscape, Mr KV Subramaniam, president, RLS, told BioSpectrum that, â€œWe are currently pursuing a multi-pronged strategy for entering the global markets for our products and services. This includes direct presence in the markets as well as entering into partnerships. RLS considers exports as an important part of its growth agenda over the next three-to-five years.â€? Today, biopharmaceuticals has a 70 percent share in RLS' overall business, which includes, biosimilars, plasma proteins and novel proteins. The emerging markets would be the key growth region for RLS' global strategy over the next three years. â€œThese markets are growing at a faster pace as compared to developed markets (like US and EU),â€? adds Mr Subramaniam. In the coming years, the company is looking to venture in to Russia and other CIS nations. ]]> <![CDATA[Nuziveedu grows 28%, retains spot No. 4]]> https://biospectrumindia.com/news/95/2667/nuziveedu-grows-28-retains-spot-no-4.html https://biospectrumindia.com/news/95/2667/nuziveedu-grows-28-retains-spot-no-4.html Thu, 09 Jun 2011 14:25:00 +0530 RANK 4 610 crore Nuziveedu Seeds Chairman & MD Dr M Prabhakar Rao Business Production and marketing of agri-biotechnology products Start-up Year: 1990 Address: NSPL ICON,4 th Floor, Road No: 12, Banjara Hills, Hyderabad-500 034 Tel: +91-40-30514444 Fax: +91-40-23327919 Website: www.nuziveeduseeds.com  NSPL is looking to invest 15 to 20 percent of its turnover in R&D and is ensuring that it successfully communicates its innovations to farmers The vision of Nuziveedu Seeds Private Limited (NSPL) is to be the most preferred seed brand in India and to adopt proactive biotech applications to strengthen its core competence. In 2010-11, the company sold about 70 lakh packets of BG I and BG II varieties of seeds in India, registering sales worth 610 crore as compared to 476.86 crore in 2009-10.   During the end of December 2010, NSL group, the parent company of Nuziveedu, decided to hive-off the seed business into a separate company, in order to have a more effective focus. Nuziveedu received a commitment for investments upto 400 crore from the global private equity major, Blackstone Group. Nuziveedu has set up an extensive marketing network that gives it a phenomenal advantage during the sales window period. The marketing network spread across 16 states in India, comprises nine regional offices, 5,000 distributors and more than 55,000 dealers and sub-dealers. Nuziveedu’s extensive sales network is toused to be one of the major reasons for its No.1 position. Nuziveedu’s competitor’s are yet to catch up with the leader. The company is known to increase its basket of offerings.  Nuziveedu has been organizing marketing campaigns in order to successfully communicate its innovations, ideas and services to the farmers. These well-timed campaigns duly inform the farmers how to increase crop productivity and farm profitability. Nuziveedu also conducts meetings between distributors, dealers and farmers to spread awareness about its products,  innovations, agronomic practices and new technologies. Nuziveedu pro-actively participates in the seed subsidy programs that have been initiated by the state governments and the central government. Through these programs, the company  tries its best to ensure that the farmers get high quality seeds at a lower price. NSPL’s research and development division has around 150 experienced technicians and workers. The main center, which is located near Hyderabad, is spread across 600 acres and has been engaged in developing superior hybrids and improved variations of different crops like, cotton, maize, rice, bajra, jowar, sunflower and vegetables among others. The company has multi-location trial centers set up in different agro-climatic zones to evaluate the adaptability of various products and screen them with respect to biotic and abiotic stress. Nuziveedu tests its products at well known national and international research institutes such as, IRRI Philippines, ICAR and state agricultural research institutes. The future plan of the company is to expand research to cover wheat, mustard, pigeon pea and sweet sorghum and invest nearly 15 to 20 percent of its turnover in R&D. ]]> <![CDATA[Panacea Biotec grows 30 percent, its highest so far]]> https://biospectrumindia.com/news/95/1847/panacea-biotec-grows-30-percent-its-highest-so-far.html https://biospectrumindia.com/news/95/1847/panacea-biotec-grows-30-percent-its-highest-so-far.html Thu, 09 Jun 2011 14:24:00 +0530 RANK 3 Revenue 928.41 crore Panacea Biotec JMD Dr Rajesh Jain Business Pharmaceuticals, biopharmaceuticals and vaccines Start-up Year: 1978 Address: B-1, Extn./G-3, Mohan Cooperative Industrial Estate, Mathura Road, New Delhi-110 044 Tel: +91-11-41679000, 41678000 Fax: +91-11-41679070, 26940199 Website: www.panaceabiotec.com Leveraging on effective business strategy and successful execution, Panacea's biotech revenue soared upto 928.41 crore, a growth of 32 percent For Panacea Biotec, the year 2010-11 has been the year of collaborations and launch of new products. The company registered a turnover of 928.41 crore in 2010-11 with an impressive growth of 32.05 percent over last year's revenue of 703.19 crore. This is considered to be the firm's highest revenue since its foray into the biotech arena. The company recorded a net turnover of 1,130 crore with a growth rate of 28 percent over last year. The revenue of the vaccine business of the company stood at 833.22 crore, whereas the revenue from the therapeutics segment stood at 4.87 crore. The revenue from biochemicals and other related products was 90.32 crore. Panacea Biotec has spread its operations to more than 35 countries in Latin America, South East Asia, CIS and Africa. The company set up wholly owned subsidiaries in strategic markets like US, Germany, Switzerland and UAE. The company has collaborations with corporations like Novartis Vaccines and Diagnostics, Sanofi Aventis, Netherland's Vaccine Institute, PT BioFarma and National Institute of Health Biotechnology Consortium of India. The company is a partner to the UN Healthcare agencies in their polio eradication initiative and supplies millions of doses of WHO pre-qualified polio vaccines. Panacea Biotec has also introduced the next gen inactivated polio vaccine (eIPV) in collaboration with the Netherlands Vaccine Institute. eIPV is registered in Bangladesh and is in an advanced stage of registration in more than 10 countries worldwide. The company supplied more than six billion doses of oral polio vaccine to Government of India and UNICEF. The company also launched its vaccines in Chile, Nepal and Pakistan and has supplied to Botswana and Switzerland. The firm is expected to send its vaccines to Peru and Philippines during Q1 of 2012. During FY 2010-11, Panacea Biotec launched PacliALL at the Indian Cancer Congress 2011. This product has been developed by Panacea's state-of-the-art Global Research and Development (GRAND) Center, Navi Mumbai. Furthermore, the company also launched EXEROZ-F and VERGRAF. According to Dr Rajesh Jain, joint managing director, â€œWe are extremely happy with the significant financial progress made in 2010-11. Our business strategy and its flawless execution has helped us deliver this excellent growth.â€? Recently, Panacea Biotec signed two non-exclusive marketing agreements with Laboratorios Clausen, Uruguay, to market its Tacrolimus (Pangraf) in defined markets in Europe. Also, in a separate agreement of technology exchange, Panacea Biotec agreed to explore the possibility of technology transfer of its product to Laboratorios Clausen. In exchange, Laboratorios Clausen would provide technology of mycophenolate mofetil (MMF) to Panacea Biotec. ]]> <![CDATA[H1N1 vaccine boosts Serum Institute topline]]> https://biospectrumindia.com/news/95/4948/h1n1-vaccine-boosts-serum-institute-topline.html https://biospectrumindia.com/news/95/4948/h1n1-vaccine-boosts-serum-institute-topline.html Thu, 09 Jun 2011 14:22:00 +0530 RANK 2 Revenue 1041 crore Serum Institute of India Chairman Dr CS Poonawalla Business Manufacturing and marketing of lifesaving immunologicals Start-up Year: 1966 Address: 212/2, Hadapsar, Off Soli Poonawalla Road, Pune- 411028 Tel: +91-20-26993900 Fax: +91-20-26993921 Website: www.seruminstitute.com Serum Institute of India is riding high on its success of H1N1 vaccine but is facing stiff competition in the overall vaccine sector Serum Institute of India (SII) clocked total sales revenue of an estimated 1,041 crore for FY 2010-11 with a growth of 22.47 percent as compared to 850 crore in 2009-10. The launch of its H1NI vaccine helped the company witness an increase in its revenue during the year. Competition and pricing pressure in the vaccine sector continue to drag down the company’s growth. SII successfully launched its indigenously developed intra-nasal H1N1 vaccine under the brand name,  Nasovac. With this launch, SII became the third  manufacturer in the country to market vaccines against swine flu, the other two companies being Cadila Healthcare (VaxiFlu-S) and Sanofi Aventis (whose  vaccines were  imported by the Indian Government). Presently, the manufacturing facility of the company has a production capacity of 50 million doses of the swine flu vaccine. The company received an order from the Government of India to the tune of 10 crore vaccines. In March 2011, the Bill and Melinda Gates Foundation announced that it would fund a part of SII’s clinical trial for rotavirus vaccines and pneumococcal vaccines. These vaccines will be sold globally at half the price of vaccines sold by big-wigs such as GSK and Merck. Last year, the company also  launched its EPO product into the market, thus finally setting foot in the growing recombinant therapeutics segment. In the past, SII’s products have been supplied to international health agencies like the WHO, UNICEF, PAHO and also to more than 140 countries across the globe. Its vaccines are being used in the national immunization programs of several countries. One of them is the HIB vaccine, an indigenously manufactured  product  launched in March 2007. SII  supplied  this vaccine to the Global Alliance for Vaccines and Immunization (GAVI), Pan American Health Organization (PAHO) and UNICEF. The vaccine is available under the brand name, SiiHIB Pro.   Since its inception, SII  has invested significantly in R&D and its efforts are yielding results.  Notable successes made by the company are: pilot production of measles vaccine on human diploid cells; industrial column chromatography and affinity chromatography for separation of immunoglobulins; monitoring of quality of vaccines in the field; clinical trials of new products and clinical trial of human diploid rabies vaccine. The company has a partnership with Syracuse University, wherein the former awarded 1.06 crore ($250,000) to a team of researchers led by Robert Doyle, to develop new oral vaccines against tetanus and rotavirus to treat a severe form of diarrhea that affects children worldwide. SII also set up the Serum Bio Pharma Park, India’s first biotech special economic zone (SEZ), in 2006. The Park is adjoining the company’s existing manufacturing unit and is a sector-specific SEZ meant for biotechnology and pharmaceutical firms. The premises has already been prequalified by the WHO. ]]> <![CDATA[BioPharma Gets lion's share]]> https://biospectrumindia.com/news/95/2457/biopharma-gets-lions-share.html https://biospectrumindia.com/news/95/2457/biopharma-gets-lions-share.html Thu, 09 Jun 2011 13:39:00 +0530 India BioPharma market comprising primarily of vaccines, therapeutic drugs, insulin, animal biologicals, statins and diagnostics, continued to grab the largest share of the total biotech industry revenue of 17,249.34 crore in 2010-11. The biopharma market accounted for 10,655 crore, with over 60 percent of market share in 2010-11. It accounted for 8,829 crore, taking 62 percent market share in 2009-10. Vaccines Vaccines sector within biopharma segment witnessed a continued growth of 12 percent during 2010-11. With the revenue of 2,441.6 crore in 2010-11, vaccines sector claimed the largest pie in the biopharma segment. In 2009-10 the vaccines sector had sales of 2,180 crore. The vaccine market will continue to drive the growth of the biopharma segment, growing in the range of 10-13 percent in the next five years. The factors that will drive this include, launch of new generation vaccines from both multinational and local companies; education and awareness about disease prevention; increase in disposable income and participation by government. During 2010, three Indian companies – Serum Institute of India, Cadila Healthcare and Bharat Biotech – launched H1N1 swine flu vaccine. In June, Ahmedabad-based Indian pharmaceutical major Cadila Healthcare was the first to launch indigenous vaccine against H1N1 in India under the brand Vaxiflu-S. VaxiFlu-S is an egg-based, inactivated vaccine, based on conventional technology developed by Cadila’s researchers at its Vaccine Technology Center (VTC) in Ahmedabad (India). VTC further plans to develop a wide spectrum of vaccines against bacterial, viral and protozoal infections. The Indian government has been importing H1N1 vaccine from global pharma major Sanofi-Aventis. In July 2010, Serum Institute of India (SII), one of India’s largest vaccine manufacturers, launched its indigenously developed intra-nasal H1N1 vaccine under the brand name, Nasovac. A live attenuated influenza vaccine (LAIV) Nasovac, is a single-dose vaccine fitted at the top of the syringe, and about 0.25 ml is administered in each nostril, mimicking the path followed by the virus, to enter the body. The product is priced at half the price of similar vaccines, marketed by Indian and foreign companies. The price of a single dose of Nasovac costs 160. Initially, SII looked at the Indian market for the product. However, it is looking at receiving the WHO pre-qualification, as it intends to market the product in 100 countries. In mid-October 2010, Bharat Biotech, another Indian leader, launched India’s first indigenously developed cell culture H1N1 swine flu vaccine under the brand name HNVAC. This claims to be the only flu vaccine to be manufactured in cell culture in the developing world, a highly sterile and controlled manufacturing process, instead of eggs. Bill and Melinda Gates, during their visit to India in March 2011, announced that they would pool in grants to fund late stage clinical trials to Pune-based Serum Institute of India and Hyderabad-based, Bharat Biotech International, for pneumonia and rotavirus vaccines. Though the companies haven’t revealed the exact value of the grants, reports say that the foundation is looking at granting around $30 million for late stage clinical trials of rotavirus vaccines. The pricing pressure and competition in the market continue to downplay the high growth (in terms of value) of vaccine market as against growth in terms of volume. India, known as vaccine manufacturing hub, witnessed a major setback during last year. Shantha Biotechnics, the first Indian company to launch an r-DNA vaccine in 1997, faced a significant drop in its revenue, as it had to recall its five-in-one vaccine — Shan5 – from across global markets following safety concerns. The WHO, which was procuring Shan5 vaccine from Shantha Biotech under a long-time contract, worth $340 million covering the period 2010-2012, advised Shantha Biotech for this product batch recall. In addition, Haffkine Bio-Pharmaceutical, a Mumbai-based public enterprise engaged in the manufacture and supply of wide range of biological and non-biological products comprising bacterial and viral vaccines, witnessed significant drop in the revenue, because the company, last year, was not able to get the global tender from agencies, such as UNICEF. However, Serum Institute of India, Panacea Biotec, Bharat Biotech and multinationals such as GlaxoSmithKline, Pfizer (Wyeth), MSD Pharmaceuticals, Sanofi Pasteur have done well by registering growth of over 10 percent during 2010-11. Diagnostics Driven by a rise in chronic diseases and investments in the healthcare infrastructure, diagnostics and therapeutics business had a positive impact on the diagnostic sector. The diagnostic market is estimated to be at 2,440 crore for 2010-11 registering growth of 22 percent over last year’s market of 2,000 crore. The diagnostics market comprises biochemical testing market, hematology, microbiology, immunology, coagulation, urinalysis, critical care and molecular diagnostics. On a broader level, this market comprises diagnostic instruments, reagents and services – which is further split into organized and unorganized sectors. The organized segment has reported strong growth to expand its reach in rural and semi-urban areas. Just like vaccine market, diagnostic market too is a highly competitive segment. The prices for diagnostic kits/tests have dropped significantly in the last 10 years with an increase in imports from China. Major MNC companies in the diagnostic market include Roche, Siemens (which has acquired Bayer Diagnostics), Johnson & Johnson and Abbott while homegrown names in the top league include Tulip Group, J Mitra & Co, Transasia Biomedicals, RFCL (Diagnova), Span Diagnostics and Trivitron. This growth is driven from the gradual acceptance of the concept of preventive and personalized medicine. The rising prevalence of diseases, improving affordability of patients and increasing penetration of health insurance have contributed substantially to spur demand for diagnostic services in the country. With the continuous increase in demand, the market is expected to post around 22-25 percent growth in the coming years. This growth is expected to drive high investments in the primary healthcare sector. Of the many subsectors in diagnostics, molecular diagnostics is emerging as one of the fastest growing segments of the diagnostics market. The main reason for such a tremendous growth is the unique ability of molecular diagnostic to treat a wide range of infectious and genetic diseases. Realizing such a huge potential, various companies are pouring investments in this segment. On the other hand, the biochemical testing market is likely to account for the largest share of the diagnostics market. Therapeutics The total biologics market in India witnessed a growth of over 35 percent and stood at over 2,000 crore for year ending 2010 as against 1,480 crore for the year ending 2009. For 2010, the human insulin and analogues market stood at over 780 crore and erythropoietin stood at 103 crore. In insulin market, Novo Nordisk India is leading the market with close to 60 percent of the market followed by Eli Lilly with about 26 percent. The other major players in the market include Aventis, Biocon, Wockhardt and Shreya Lifesciences. Today, there are 20 recombinant therapeutic products approved for marketing in the Indian market. And, Indian companies have established capabilities to manufacture about 15 of these recombinant therapeutic products. Out of these, the products that have a large share in the market include Human insulin Erythropoietin Hepatitis-B vaccine (recombinant surface antigen-based), Human Growth Hormone, Granulocyte Colony Stimulating Factor (GCS-F) and Streptokinase. Close to 50 brands are being marketed in India by Biocon, Shantha Biotechnics, Bharat Serums and Vaccines, Virchow Biotech, Zenotech, Reliance Life Sciences, Bharat Biotech International, Wockhardt, Shreya Life Sciences, Intas Biopharmceutcials and Shreya Life Sciences-manufacturing an average of five brands in India and about 72 recombinant therapeutic products are at different stages of clinical trials. From just six top Indian companies with manufacturing capabilities in recombinant therapeutic products in 2005, the number has more than doubled to about 15 companies in 2011. Dr Reddy’s Laboratories that sells biologic products — Grafeel and (generic Filgrastim) and Reditux, (generic Rituximab) has launched Peg-grafeel in May 2011. Priced at 8,865, the product represents a breakthrough in the pricing of this complex molecule. It is priced at approximately 25 percent of the originator brand in India, and is priced 95 percent lower than the US price for pegfilgrastim. This breakthrough in pricing has been enabled by the company’s vertically integrated global manufacturing network. Besides, it has another 11 biosimilars in various stages of development and commercialization. India will see launch of many biosimilar products in the next two years, as many biopharma companies have been working on these products for the last few years and are now in different phases of clinical trials. With the launch of these products the biopharma market will see growth of over 25 percent by 2012. ]]> <![CDATA[BioInformatics Set for a growth spurt]]> https://biospectrumindia.com/news/95/5376/bioinformatics-set-for-a-growth-spurt.html https://biospectrumindia.com/news/95/5376/bioinformatics-set-for-a-growth-spurt.html Thu, 09 Jun 2011 13:37:00 +0530 The bioInformatics segment, which is the smallest of industry segments constituting barely two percent of the market share in the overall industry revenue, grew by 4.95% in FY 2010-11. The segment clocked 242.43 crore in this fiscal as compared to 231 crore in FY 2009-10. The major players in the segment, Strand Life Sciences and Ocimum Biosolutions collectively contributed 107 crore to the overall revenue. The factors contributing to this growth include tracking of discovery activities, data analysis, and pharma research. The different sub verticals covered under it are Informatics, Omics, Lab information, Clinical Data Management and Biostatistics. Most of the companies in this segment are small-scale enterprises located in cities such as Pune, Mumbai, Bangalore and Hyderabad. Innovative companies such as Strand Life Sciences, Ocimum Biosolutions, V Life Sciences, SysArris, Cell works, CytoGenomics and Molecular Connections are working towards speeding up the cause of the core life science business. The segment is also getting a push with large IT companies such as Cognizant, HCL, Wipro, TCS joining the fray. However, BioSpectrum Survey 2011 does not include revenues of these IT companies in its analysis, as that will skew the survey results. The latest trends in the field that can contribute to the future growth of the segment include translational bioinformatics, personalized medicine and genomics. Next five years will see the sector wriggle out of its current position and take the centerstage. Host of developments are taking place in the genomics and molecular research that will likely boost the bioinformatics industry. Significant advances in the field of proteomics and related technologies will influence the way research and diagnostic analysis are performed. With the increase in R&D investments by various companies and the government support, it is clear that in the years to come, the bioinformatics market will post a steady growth. During the year, Ocimum Biosolutions, a leading bioinformatics company has closed funding worth $8 million from multiple sources, including founders and existing shareholders, in order to cater to the growing demand for its integrated genomic services and to provide unparalleled, hassle-free user experience by enhancing its RaaS (Research as a Service) platform. The company is in the process of building a state-of-the art integrated campus in Patancheru, Hyderabad. Part of the funds will be utilized into completing  the 360,000 sq ft facility spread across four blocks. Ocimum started providing BioIT consulting services to enable R&D for organizations in the life sciences industry. It also launched its quantitative real-time polymerase chain reaction (qRT-PCR) services in India. This technology is already in use at Gene Logic, an Ocimum Biosolutions company. In the last quarter of 2010, Strand Life Sciences, another leading name in the sector, announced the creation of a US-based subsidiary Strand Scientific Intelligence, Inc (Strand SI) to commercialize its innovative Scientific Intelligence solutions at the global level. The company also announced the worldwide release of Avadis NGS, a software application for next-generation sequence (NGS) analysis. Top 3 BioInformatics Companies by Revenue (2010-11) Rank Company Revenue in Crore 2010-11 Revenue in Crore 2009-10 Revenue in Crore 2008-09 Change over 2009-10 (%) 2010 (%) Change over 2008-09 (%) 2011 (%) 1 Ocimum Biosolutions 65.00 41.40 47.57 -12.97 57.00 2 Strand Life Sciences 42.00 35.00 35.00 0.00 20.00 3 Geschickten 0.65 — — — — ]]> <![CDATA[Nano antibodies to treat diseases]]> https://biospectrumindia.com/news/95/8456/nano-antibodies-to-treat-diseases.html https://biospectrumindia.com/news/95/8456/nano-antibodies-to-treat-diseases.html Thu, 09 Jun 2011 13:17:00 +0530 The National Research Center on Camel (NRCC), Bikaner, initiated a study to test camel immunology in collaboration with the Bhabha Atomic Research Centre, Mumbai. Since camel’s immunology is unique, the antibodies produced in its blood stream are very special and are called nano antibodies, which have the potential to treat various diseases. These antibodies are also expected to be used for human disease diagnostics as well as treatment. Dr N V Patil, director, NRCC, highlighted that the institute was working with the Bhabha Atomic Research Centre to study the effectiveness of these antibodies on diseases like TB and also in the diagnosis and treatment of thyroid cancer. Interestingly, NRCC is also collaborating S P Medical College, Bikaner, to develop an anti-snake venom. Dr Patil said that the nano antibodies traverse through the animal and human body extremely fast to reach their target, passing internal barriers like the blood-brain barrier and placental barrier. He also pointed out that there is great prospect in this area for developing drugs for diseases of animals and human. Indo-German disease R&D initiative The Indian Council of Medical Research (ICMR) and Helmholtz Association of German Research Centres (HGF), Germany, have launched a fellowship under the Indo-German Science Centre for Infectious Diseases (IG-SCID) for the financial year 2011-2012. IG-SCID is a joint initiative of HGF and ICMR with the mission to strengthen Indo-German cooperation in the field of infection research. The purpose of this fellowship is to provide opportunities to Indian and German researchers to undertake research in thematic areas of infectious diseases. Six fellowships, each of a duration of three months, would be granted each year by both the Indian and the German organization. Thematic research areas of infectious diseases for training include, genetic susceptibility, viral diseases (HIV/HCV) vaccine and anti-infectives, zoonoses & animal models of infectious diseases. The programme will enable Indian scientists to visit several German institutes such as, the Helmholtz Centre for Infection Research (HZI), Braunschweig; TWINCORE Centre for Experimental and Clinical Infection Research, Hannover; MHH Medical University, Hannover and Helmholtz Institute for Pharmaceutical Research Saarland (HIPS), Saarbrücken. ICMR constitutes Vector Science Forum The emerging and re-emerging vector borne diseases like dengue, chikungunya, japanese encephalitis, chandipura virus, nipah viruses, malaria, filariasis, and visceral leishmaniasis have posed a great challenge to researchers, disease control programme planners and implementers in the country. In this context, the Indian Council for Medical Research (ICMR) has now constituted a ‘Vector Science Forum’ in order to promote research on vectors and to develop a common platform for all vector biologists, entomologists, programme people and experts embarking upon common issues. The projects would be funded by ICMR and will involve extensive research in selective priority areas. ICMR expects the forum to help in the field of evaluation trials to evaluate new insecticides, vector control tools in different vector eco-systems and evaluation of diagnostic kits and assays for parasite detection. Gene therapy to cure AMD A new in vivo study by researchers at Tufts University School of Medicine revealed that a new gene therapy approach using a protein called CD59, or protectin, has a lot of potential to slow the signs of age-related macular degeneration (AMD). The team, which was led by senior author Dr Rajendra Kumar-Singh demonstrated for the first time that CD59 delivered by a gene therapy approach significantly reduced the uncontrolled blood vessel growth and cell death that is typical of AMD, which is the most common cause of blindness in the elderly. Activation of the complement system, a part of the immune system, leads to the generation of pores known as ‘membrane attack complex’ or MAC in cell membranes, which leads to the killing of the cells in the back of the eye and causes AMD. CD59 is known to block the formation of MAC. Using an established mouse model of AMD, they found that the eyes had 62 percent less uncontrolled blood vessel growth and 52 percent less MAC than the controls. The current standard treatment for some forms of AMD requires an injection directly into the eye approximately every four weeks. According to Dr Kumar-Singh, gene therapy approaches to treat AMD are especially attractive because they will allow patients to be treated less frequently, reducing patient discomfort and lowering chances of infection. The study received grants from The Ellison Foundation, the National Eye Institute, the National Institutes of Health, the Virginia B Smith Trust, the department of ophthalmology at TUSM, the Lions Eye Foundation and Research to Prevent Blindness. ]]> <![CDATA[GlaxoSmithKline net sales up 11.4%]]> https://biospectrumindia.com/news/95/2847/glaxosmithkline-net-sales-up-11-4.html https://biospectrumindia.com/news/95/2847/glaxosmithkline-net-sales-up-11-4.html Thu, 09 Jun 2011 13:13:00 +0530 GSK announced its financial results for the first quarter, ending March 31, 2011. The overall sales increased by 11.4 percent and net sales of the pharmaceuticals business witnessed a rise of 12.4 percent, while profit after tax grew by 16 percent. Marketing approvals were also received for two innovative products including, Votrient, which can be used for treating renal carcinoma and Revolade, which can be used to cure platelet depletion. GSK expects to launch these products in the ensuing quarter. GSK Pharmaceuticals is a subsidiary of GlaxoSmithKline plc, one of the world’s leading research-based pharmaceutical and healthcare companies. Jubilant reports Q4 profit of 61 crore Jubilant Life Sciences reported a consolidated net profit of 61.72 crore for the fourth quarter ending March 31, 2011 as compared to 137.16 crore during the same period in the previous fiscal year. The company’s net sales for the quarter stood at 890.34 crore as against 991.83 crore reported in the same period during the last fiscal. Commenting on the performance of the company, CMD Mr Shyam S Bhartia, highlighted that during the financial year 2011, the company recorded a good revenue growth in its products’ business, which was fueled by a robust volume growth of 16 percent. The firm has gained confidence due to its increased capacity utilization, commissioning of new plants, innovation led new launches and expansion of market geographies. Ranbaxy registers Q1 sales of 2,146 cr Ranbaxy Laboratories declared its financial performance for the first quarter ending March 31, 2011. The consolidated sales of the company for the quarter were 2,146 crore as compared to 2,484 crore in the corresponding quarter in the previous year. Earnings before interest, tax, depreciation & amortization (EBITDA) was 20 percent of sales at 428 crore as compared to 983 crore. The Indian market recorded sales worth 435 crore, which is a growth of 14 percent. Of this, sales in the consumer healthcare business stood at 59 crore, a growth of 35 percent. The Asia Pacific region recorded sales of 76 crore, a growth of 17 percent, which was mainly driven by higher sales in some smaller markets. The key highlights of this year’s performance of the company include the increase in its market share to 4.78 percent, as compared to 4.63 percent in Q1 of 2010. Also, Ranbaxy redeemed the $440 million foreign currency convertible bonds, on the due date. During the quarter, over 10 regulatory agencies from across the globe, inspected and approved Ranbaxy’s API and dosage form (DF) facilities, in multiple locations. Dr Reddy’s Q4 net profit dips 34% Dr Reddy’s Laboratories announced its unaudited consolidated financial results for the quarter and full year ending March 31, 2011 under International Financial Reporting Standards (IFRS). The firm’s consolidated revenues were 7,470 crore in the financial year 2011 as compared to 7,030 crore in the financial year 2010 with an year-on-year growth of six percent. The company witnessed good and sustained growth across all key for-mulation markets in the financial year 2011. North America’s revenue witnessed a growth of 18 percent in dollar terms and 11 new products were launched in the region. Sequential growth of 23 percent in Q4 FY11 over Q3 FY11 demonstrates the fifth consecutive quarter of sequential growth. The business in Russia witnessed revenue growth of 29 percent in dollar terms, due to growth in volumes and OTC initiatives. India’s revenue growth was 15 percent, with sustained growth of key brands and new products introduction. In Germany, revenue declined 17 percent in Euro terms, however, improved significantly in profitability. During the year, the company launched 135 new generic products, filed 107 new product registrations and filed 56 DMFs globally. The company also forayed into many strategic initiatives. The firm acquired a penicillin facility to fill the portfolio gap in the anti-bacterial segment in the US. The company also collaborated with Valeant Pharma to market Cloderm Cream in the dermatology space in the US. GVK to focus on neglected diseases GVK Biosciences has been selected as a preferred provider to a consortium of 14 global product development partners (PDPs) for clinical services in Asia. It is the only partner that is headquartered in India. The PDPs, funded in part by the Bill and Melinda Gates Foundation are not-for-profit entities focused on developing new interventions for neglected diseases. Collectively, the 14 PDPs would fund 85 clinical trials in the developing world over the next two years and India features as a key developing world country. Indian CRO buys stake in aCROnordic Ecron Acunova acquired a majority stake in Denmark-based aCROnordic, a CRO specialized in clinical research in Sweden, Finland and Norway. The firm has its headquarters located in Denmark’s leading bio-science park, SCION DTU in Hoersholm near Copenhagen. Mr DA Prasanna, founder and chairman of Ecron Acunova, highlighted that a recent change in the strategy of sponsors in the healthcare industry asks for a more global presence of preferred provider CROs. Mr Søren Strøh, founder and former owner of the firm will continue his role as CEO for the Nordic region. Glenmark and Sanofi enter deal Glenmark Pharmaceuticals announced that it entered into an agreement with Sanofi Aventis to grant a license for the development and commercialization of GBR 500, a novel monoclonal antibody used for the treatment of Crohn’s Disease and other inflammatory conditions. Sanofi will have exclusive marketing rights for North America, Europe, Japan, Argentina, Chile and Uruguay and Glenmark will co-market in Russia, Brazil, Australia and New Zealand. Glenmark will retain exclusive marketing rights in India and other countries in the rest of the world. Glenmark’s other biologics molecules include GBR 600 which has completed phase I studies, GBR 401 which is in pre clinical studies and GBR 900 which again is at early stages of development. Indegene bags seven Hermes awards Indegene Lifesystems, a scientific partner to global pharmaceutical and life sciences companies, won seven awards at the prestigious Hermes Creative Awards 2011. Hermes Creative Awards is an international competition for creative professionals involved in the concept, writing and design of traditional materials, programs, and emerging technologies. They are administered and judged by the Association of Marketing and Communication Professionals. There were about 4,400 entries in this year’s competition. This year Indegene won four platinum awards under the categories of ‘Overall Website,’ ‘e-Learning Solutions,’ and ‘Advertising Campaign’. In the Gold awards grouping, Indegene won three awards under the categories of ‘Overall Website,’ ‘e-Learning,’ and ‘Video-Marketing Services.’ As a leading commercialization and marketing service provider to pharmaceutical companies across the globe, Indegene has a proven track record of winning awards year-on-year for some of its most creative medical and marketing initiatives. Last year, the company won two awards, including one Gold and one Platinum award at the Hermes Creative Awards 2010. Jubilant repays $202 mn for FCCBs Jubilant Life Sciences, the largest custom research and manufacturing services company in India, announced the prompt repayment of $202 million on account of outstanding FCCBs including YTM of $60 million. The company has repaid all the outstanding FCCBs on time, as per schedule, in line with the terms and conditions of the FCCB instruments, showing its commitment to meet its obligation on time and also demonstrating its financial strength. Jubilant’s CMD, Mr Shyam S Bhartia, and co-CMD, Mr Hari S Bhartia, highlighted that the firms’ objective is to strengthen the balance sheet by using a more optimal mix of capital. They also revealed that after the repayment of the previous FCCBs, worth $202 million, there is no major debt repayments that is due for the next three years. Jubilant Life Sciences has good visibility of growth and has exciting plans to augment capacities, introduce products and enter new markets across the various lines of businesses, thereby driving revenue and earnings growth momentum of the company. TN beats Karnataka in biofertilizer use Tamil Nadu has overtaken Karnataka in biofertilizer usage according to the data on use of biofirtilizer released by the Ministry of Agriculture, on May 18, 2011. In 2009-10, Tamil Nadu produced 3,733 tonnes of bio-fertilizers followed by Karnataka 3,696 tonnes. The other major producers of bio-fertilizers are Kerala (1,937 tonnes), Maharashtra (1,861 tonnes) and Madhya Pradesh (1,588 tonnes). Studies on the benefits and the usefulness of bio-fertilizers on agriculture production reveal that on an average 10-20 percent increase in production can be realized by the use of bio-fertilizers. In terms of nutrients, bio-fertilizers can provide 10-20 kg nitrogen and can solublize 10-12 kg of phosphorous pentoxide per hectare per cropping season. Use of bio-fertilizers also improve soil health by helping other beneficial micro-organisms to grow. ]]> <![CDATA[BioEvent - Bangalore India Bio 2011]]> https://biospectrumindia.com/news/95/1796/bioevent-bangalore-india-bio-2011.html https://biospectrumindia.com/news/95/1796/bioevent-bangalore-india-bio-2011.html Thu, 09 Jun 2011 13:09:00 +0530 Dignitaries releasing the Bangalore India BIO 2011 document on the inauguration of 11th edition of Bangalore India BIO 2011, which was held from May4-6 at Bangalore. Seen in picture from L-R: Dr Kiran Mazumdar-Shaw, chairperson, Karnataka's Vision Group on Biotechnology and CMD, Biocon; Mr Jerome Bonnafont, Ambassador of France to India; Mr BS Yeddyurappa, chief minister of Karnataka; Dr VS Acharya, Minister for Higher Education, Planning & Statistics, Muzrai, Information Technology and Biotechnology, Government of Karnataka; Mr Freddy Svane, Ambassador of Denmark to India; Dr VM Katoch, secretary to the Government of India, Department of Health Research, Ministry of Health and Family Welfare; and Mr Aravind Jannu, director, Directorate of IT & BT and managing director, KBITS, Government of Karnataka. The three-day-long Bangalore India BIO 2011, which is India's premier biotechnology event covering all the major trends in biotechnology and its related fields, attracted over 800 delegates from different parts of India and saw participation from countries such as France, Denmark, Singapore, Australia, USA and several other nations from the European Union. Mr BS Yediyurappa, chief minister, Government of Karnataka, inaugurated the conference and exhibition at the Bangalore International Exhibition Center (BIEC) on May 4, 2011. He handed over the Letter of Intent to Mr Vishal Goel, managing director, Alexandria Equities Management for developing Bangalore Helix, a biotechnology park to be built in public-private partnership, on 56 acres of land in Bangalore. Mr Goel said, â€œThe park is being built at a cost of 500 crore and will come up in a record two-year time, with the construction commencing from October this year.â€? The chief minister also handed over cheques worth 50 lakh to 12 biotech finishing schools, which will be commencing the specialized courses from the June 2011 academic year. These finishing colleges will offer specialized courses that would enable students to focus on one particular topic of their choice, such as fermentation, bioinformatics, clinical trials or clinical data management, instead of covering the entire field of biotechnology. Mr M N Vidyashankar, principal secretary, Department of IT, Biotechnology and S&T, Government of Karnataka, said, â€œThe event has truly become a gateway to India for the international biotech community. I am glad that the Bangalore Helix project will be put on fast track with the completion of selection process. The state government's commitment to create the much-needed talent pool for the biotech sector will be met through initiatives like the biotech finishing schools, which was launched by the Government of Karnataka in this event.â€? Dr V S Acharya, minister for Information Technology and Biotechnology released the program document of Bangalore India BIO 2011. Dr V M Katoch, secretary to Government of India, Department of Health Research, Ministry of Health and Family Welfare released the Frost & Sullivan report named â€œOpportunities in pharma biotech Special focus on biosimilars as the next biotechnology sector for Indiaâ€?. Dr Kiran Mazumdar-Shaw, chairperson, Karnataka's Vision Group on Biotechnology and chairman & managing director, Biocon, said, â€œThe biotech world is all about partnering, collaborations, leveraging each other's strengths and synergizing them to deliver affordable innovation. It is also about making sure that entrepreneurs are recognized, celebrated and born every day. This is what Bangalore India BIO's focus has always been and this is what the event will do in the years to come. Next year, the conference will focus on safety, security and sustainability.â€? Speaking on how value creation can be achieved through innovation, in the field of biotechnology, Dr Kiran Mazumdar-Shaw, said that, â€œWe need to create an experimental culture, foster an entrepreneurial environment, and incentivize business differentiation. Concept and ideas aren't enough, they need to be translated and implied in a manner that is beneficial to others.â€? The mega event was organized by the Department of Information Technology, Biotechnology and Science & Technology, Government of Karnataka; Vision Group on Biotechnology; MM Activ Sci-Tech Communications and Association of Biotechnology Led Enterprises (ABLE), a consortium of Indian biotechnology companies. The event, whose focus theme was - 'Biotech for a better tomorrow', consisted of multi-track conferences, international trade shows, biopartnering meetings, a ceo conclave and a bio-excellence award ceremony among a host of other events. Multi-track conferences consisted of 21 sessions and featured 116 speakers. The sessions were attended by 815 delegates and 450 organizations from 22 countries including Denmark, France and Belgium. Agri and industrial biotech day was inaugurated with the vision talk by Prof Samir K Brahmachari, who is the director general of Council of Science and Industrial Research (CSIR) and is also the secretary to the Government of India, Department of Scientific and Industrial Research (DSIR). The BioPartnering India initiative received a phenomenal response with over 530 business meetings. Bio Excellence Awards were presented in the categories of bio-pharma, agri-bio, bio-services, industrial-biotech and bio-informatics. The selection of the various award winners were conducted by ABLE. Dr Kiran Mazumdar-Shaw announced that the next Bangalore India BIO will be held on February 6-8, 2012. Bio Excellence Award winners From L-R: Mr Balaji Iyengar, CEO-India, Ecron Acunova; Mr B N Manohar, CEO, Stempeutics Research; Mr D A Prasanna, CMD, Ecron Acunova CRO (winner-Bio Excellence Award in bioServices sector); Dr N Prabhudev, VC, Bangalore University and Mr M.N Vidyashankar, principal secretary, Department of IT, Biotechnology, Karnataka. Dr N Prabhu Dev, vice chancellor of Bangalore University, presented Bio Excellence Awards and Emerging Company of the Year Awards to 10 companies belonging to different sectors such as bioindustrial, biopharma and healthcare, bioservices, bioagri and bioinformatics & systems biology. Rossari Biotech got the Bio Excellence award under bioindustrial category and Richcore Lifesciences bagged the Emerging Company of The Year award under biopharma & healthcare. Concord Biotech got the Bio Excellence award and Stempeutics Research was named the Emerging Company of The Year award. Ecron Acunova and Suven Lifesciences both received the Bio Excellence award as there was tie between the two firms under the bioservices category, while Anthem Biosciences got the Emerging Company of The Year award. Nath Seeds got the Bio Excellence award under the category of bioagri. Under the bioinformatics & systems biology category, Strand Life Sciences got the Bio Excellence award and Cellworks Research India was awarded the Emerging Company of the Year Award. Dr Kiran Mazumdar-Shaw, CMD, Biocon, India, said, â€œThere are several parameters based on which the awards have been given. A few of these parameters included the growth of the company, success of commercialization, the kind of products produced by the company, innovation, exports and investment attracted by the company among others.â€? Dr Vijay Chandru, chairman & CEO, Strand Life Sciences and president, ABLE said, â€œGiving recognition to emerging companies not only boosts the company's morale but in turn it encourages the smaller firms.â€? Agri innovation center in Bangalore To boost up the developments in the agri-biotech space, the Karnataka government will set up an innovation centre for agri-biotech in Bangalore, worth 80-100 crore in association with the Council of Scientific and Industrial Research (CSIR). The center will come up on a joint (50:50) partnership basis and would be spread across an area of 200,000 sq ft. Mr M N Vidyashankar, principal secretary to the Government, Dept of Information Technology, Biotechnology and Science & Technology, Government of Karnataka said, â€œThe facility would be a greenfield project. The center would be commissioned within 18 to 24 months. The center would be dedicated to promoting R&D of innovative technologies. There would also be an area earmarked for testing and quality control studies.â€? ABLE forms new group for regenerative medicine & cellular therapies. Considering the activities that are happening in the field of stem cells and regenerative medicine in India, the Association of Biotechnology Led Enterprises (ABLE), a consortium of Indian biotechnology companies, announced the formation of regenerative medicine & cellular therapies group (RMCT) with three members from different background in the field of stem cells. The members of the new group include, the Institute for Stem Cell Biology and Regenerative Medicine (inStem), an autonomous institute of the Department of Biotechnology; Life Cell International, India's first private cord blood bank that facilitates the cryogenic preservation of umbilical cord blood stem cells at its unique facility in Chennai and Stempeutics Research, a leading stem cell company developing stem cell based medicinal products, with facilities in Bangalore and Manipal (India) and Kuala Lumpur (Malaysia). ]]> <![CDATA[South catches up with the west]]> https://biospectrumindia.com/news/95/1547/south-catches-up-with-the-west.html https://biospectrumindia.com/news/95/1547/south-catches-up-with-the-west.html Thu, 09 Jun 2011 13:05:00 +0530 Æ’Ã? South and west, both claim 44 percent market share each Æ’Ã? South region improves its share over last year by five percent Æ’Ã? Gujarat tops in attracting investments The south region has caught up with the west, improving its share in the overall Indian biotech industry to 44.22 percent in 2010-11 from 39 percent in 2009-10. It is slightly above the west region¡¦s share of 43.60 percent. Top 10 companies in the south have contributed `4,816.47 crore (27 percent) of the total biotechnology industry revenue, while Top 10 companies from west have about 21.17 percent of the total industry contributing `3,651.25 crore. Biocon from the south region continued to retain its position as the No. 1 biotechnology company with `1,480 crore followed by Serum Institute of India from west with `1,041 crore. The north region with `2,100.66 crore has 12.18 percent share in the overall industry. In terms of number of companies, south continued its dominance with 175 companies, while west has 139 companies and north is still to cross 50 figure mark. It had 48 companies. In south, Karnataka is one of the active states focusing much on biotechnology. To support the biotech industry, Karnataka government has finally signed an agreement with Alexandria Equities Management (India) for developing Bangalore Helix, a biotechnology park built on public-private partnership on 56 acres of land in Bangalore. The park built at a cost of `500 crore will come up in a record two-year time and the construction will commence from October 2011. Karnataka has signed MoU with two companies during Global Investor¡¦s Meet in June 2010 ¡X HPCL and Nandan Biomatrix, which will be investing about `557 crore and `96 crore, respectively on Green R&D centre and Bio Investment Eco Industrial Zone. Karnataka is also planning to start sector specific parks¡Xagri-biotech park in Dharwad (with the University of Agricultural Sciences), a marine park in Mangalore (with the State Fisheries Department), a veterinary park at Bidar (with the Veterinary University) and a nutraceuticals and pharma products park in Mysore (along with the Central Food Technological Research Institute). In Andhra Pradesh, Lepakshi Knowledge Hub is setting up Lepakshi Knowledge Park in Hyderabad. It is spread on 700 acres of land with R&D labs, pilot plants focusing on sectors such as healthcare, pharma, biotech, medical devices and healthcare delivery. Lonza, the leading supplier to the life science industry is also setting up its R&D facility in 26 acres, in Andhra Pradesh. Sri Biotech is coming up with `30 crore project, focused on agri-biotech research in Andhra Pradesh. During the year, Tamil Nadu government proposed to set up a marine biotechnology park near Mahabalipuram, in about 300 acres. At the same time, the state is in the process of setting up a biotechnology core facility at TICEL Bio-Park II at a cost of `19.30 crore. The facility would provide scientific and incubation support to the biotech industry. In north, during the year, Mayar Biotech SEZ located at Gurgaon stepped-up its efforts to attract biotech companies. An Indo-German Science and Technology Centre (IGSTC) was also inaugurated at Gurgaon to promote research and focus on public-private partnerships. Initially, three projects in the biotechnology space have been taken up. Besides, Lucknow Biotech Park has also taken many initiatives to promote the agri-biotech sector in the region. The work at biotech parks at three locations ¡X Sitapura-Jaipur, Chpanki-Bhiwadi and Borandi in Rajasthan ¡X has also witnessed progress, and is expected to attract investors in coming times. The year saw Himachal Biotech Park getting clearance from the state government and assistance from the central government. The 200 crore biotech park coming up on 35 acre land near Nalagarh in Solan district is expected boost the employment and other financial requirements of the region besides attracting the investors from India and abroad. In the west, government of Gujarat has signed a total of 35 biotechnology related MoUs during ¡§Vibrant Gujarat-Global Investors Meet,¡¨ in January 2011, with investment commitment of around `5,858 crore, spread over coming five-to-six years. Nectar Life Science India, a Chandigarh-based company, is making a whopping investment of around `3,500 crore in two phases, in the state, in predominantly biotech projects and into production of vitamins and co-enzymes. In addition to medium-to-large companies, another 14 companies, have committed an average investment of `9-10 crore. Some of these companies are Dos Advanced Agro-Biotech, Phyto-concentrates, Gujarat Agroland, Centurion Labs, Biotron, Poshak Bioresearch, Sabre Machinery. Besides, promotion and support from the state governments, the Department of Biotechnology is stepping-up efforts to promote the biotech R&D activities in North East Region, which is one of the world¡¦s biodiversity hotspots. Top Companies in West Rank Company Revenue in ` Crore % Share in Region % Share in industry revenue 2010-11 1 Serum Institute of India 1041.00 13.84 6.04 2 Reliance Life Sciences* 490.00 6.52 2.84 3 Mahyco* 364.90 4.85 2.12 4 Transasia 350.00 4.65 2.03 5 Ankur Seeds 325.00 4.32 1.88 6 Krishidhan Seeds 276.13 3.67 1.60 7 Bharat Serums 226.00 3.00 1.31 8 Siro Clinpharm* 202.00 2.69 1.17 9 Cadila Healthcare* 190.59 2.53 1.10 10 Tulip Group 185.63 2.47 1.08 Top 10 West 3651.25 48.55 21.17 Total West 7521.00 100.00 43.60 Top Companies in South Rank Company Revenue in ` Crore % Share in Region % Share in industry revenue 2010-11 1 Biocon 1483.00 19.44 8.60 2 Nuziveedu Seeds 610.00 8.00 3.54 3 Quintiles India* 476.25 6.24 2.76 4 NovoNordisk 462.00 6.06 2.68 5 Rasi Seeds 371.88 4.88 2.16 6 Syngene International 318.00 4.17 1.84 7 Bharat Biotech * 298.34 3.91 1.73 8 Indian Immunologicals 283.00 3.71 1.64 9 Shantha Biotech* 272.00 3.57 1.58 10 Novozymes South Asia * 242.00 3.17 1.40 Top 10 South 4816.47 63.14 27.92 Total South 7627.68 100.00 44.22 Top Companies in North Rank Company Revenue in ` Crore % Share in Region % Share in industry revenue 2010-11 1 Panacea Biotec 928.41 44.20 5.38 2 Jubilant Life Sciences 210.00 10.00 1.22 3 EliLilly 204.00 9.71 1.18 4 RFCL (Diagnova) 103.00 4.90 0.60 5 Max Neeman International 48.04 2.30 0.28 Top 5 North 1493.81 71.11 8.66 Total North 2100.66 100.00 12.18 ]]> <![CDATA[BioSpectrum-ABLE Survey Records the Biotech Industry Pulse]]> https://biospectrumindia.com/news/95/6891/biospectrum-able-survey-records-the-biotech-industry-pulse.html https://biospectrumindia.com/news/95/6891/biospectrum-able-survey-records-the-biotech-industry-pulse.html Thu, 09 Jun 2011 12:46:00 +0530 Dr Satya Dash Dr Satya Dash is the COO of Association of Biotechnology Led Enterprises (ABLE), the pan Indian apex biotechnology industry body. He is based out of Bangalore, India This is the 9th year that BioSpectrum & ABLE have collaborated to track the biotechnology industry growth in India. This yearly survey is eagerly awaited by all the stakeholders interested in the status report and growth opportunities in this vibrant knowledge-based industry. It is clear from the revenue statistics that the trend of growth in this industry has continued and the industry has crossed 18,000 crore or $4 billion in dollar terms, posting a 21 percent growth over previous year’s revenues of over 14,000 crore (approx $3 billion). However, despite the expectations, the industry has not touched $5 billion yet – perhaps the after effects of the severe recession in 2008 are still being felt globally. Established  Players & New Entrants It is interesting to note the overall ranking in this sector. While the top players have maintained their positions with Biocon, Serum & Panacea leading the way, Transasia and Ankur Seeds have posted exponential growth figures to leapfrog to 10th & 11th position respectively. Continuing the trend of growth in the seed business, Krishidhan Seeds has also climbed to join the top 20 firms. Other biotech SMEs that have shown incredible growth over the last year are Anthem Biosciences, JK Agrigenetics, Metahelix, Bayer Cropscience, Ecron Acunova and Semler Research. Surprisingly though, many established players have seen a fall in revenues such as Shantha Biotech, Jubilant Life Sciences and Suven Life Sciences. The Southern-Western Leadership The southern region is slightly ahead of the western region in terms of total share of revenues, however, the south comfortably leads in the number of firms (172 vs 137). Bangalore and Hyderabad are leading the way and the recent announcement of building a cluster and incubator in Bangalore will help maintain the leadership of this region. The north cluster follows at the third spot but hopefully new clusters, especially in the NCR, will help close the gap in the future. What is revealing is, that despite possessing huge bio-resources and many leading institutions, the eastern part of India is lagging in terms of proper biotech enterprises. The states of Bihar, West Bengal, Orissa, Assam and the North East need a focused strategy to seed biotech enterprises. The survey shows that there are now 362 firms in India that are focussed on some aspects of biotechnology. This is an important indicator. The vibrancy of a knowledge intensive and highly regulated industry such as biotech depends on the number of new start-up firms that are establishing and injecting fresh business ideas, solutions, and products built on innovation. What do we need to have in policy terms to say that India can treble the number of innovative biotech firms in the next five years to cross the one thousand mark? How do we make the biotech landscape investor friendly and ease the burden of establishing and operating start-ups? Indeed for the sector to grow even further several concomitant factors have to be addressed: Streamlining Regulation: Regulation that enables innovation is the key. ABLE facilitated, as “Knowledge Partner” a regulatory session at Bangalore INDIA BIO last month. What became clear from discussions there as well as from all other fora is, that Industry will like to have a scientific evidence-based, clear and non-ambiguous, streamlined and transparent regulatory mechanism where procedural delays are minimized and technical considerations are dealt with by expert committees that are not created on an ad-hoc basis. For India to achieve a leadership position in biotechnology, this is foremost in all sectors of biotechnology, i.e., biopharma (including diagnostics & devices), agri-biotech and industrial biotech including food & nutrition. Indeed, it goes without saying that investor confidence is directly linked to a clear and streamlined regulatory landscape. Early Stage Funding The unique nature of this sector necessitates very early stage funding especially at the “pre-prototype” stage, for this is where the risks are at their highest for both big and small biotech firms alike. While SBIRIs and BIPPs have injected much-needed early stage funding, India has to find a mechanism to scale-up these funding mechanisms. The recent DBT-Wellcome Trust initiative in “R&D for affordable healthcare” is indeed a step in the right direction. Another important bottleneck has been the “DSIR certification” criteria for access to these funding schemes. Perhaps streamlining the DSIR certification process such that valuable time and energies are not lost for firms will go a long way. Access to Technology Resources Common access to efficiently-run technology platforms for the industry is crucial as it saves cost and time while it allows firms to conduct cutting edge development of products. The Future Ahead Indian biotechnology industry is showing signs of consistent and mature growth in the 20 percent range. It has done well despite the global recession. Indian biotech firms are globalizing and strategically partnering with other firms – the Pfizer-Biocon and Glenmark-Sanofi deals are indicators of the kinds of new partnerships to emerge. It is clear that vaccines, diagnostics and devices along with biosimilars will be key growth areas in biopharma. The agri-biotech sector is poised to grow – especially, the seed business in the area of new hybrids. Regulatory clarity in both biopharma/healthcare & agribiotech will be crucial for the future. There is a perceptible dynamism in systems biology (or BioIT) firms that are building predictive models, both disease and organ models, and enabling drug discovery research. The growth potential of BioIT firms in India built on India’s strengths in IT and biology remains high. The CRO industry has become highly competitive and many CROs now have to show unique differentiation other than cost arbitrage. Many CROs have chosen to follow a risk-sharing model for growth to transition themselves into drug discovery firms. While this transition might take years it is a positive trend for the industry. ]]> <![CDATA[Denmark calls out for Asian investment]]> https://biospectrumindia.com/news/95/2481/denmark-calls-out-for-asian-investment.html https://biospectrumindia.com/news/95/2481/denmark-calls-out-for-asian-investment.html Thu, 09 Jun 2011 12:44:00 +0530 Denmark boasts of the third largest drug pipeline in Europe and is a leader in areas of enzymes, CNS, diabetes and cancer reseach. BioSpectrum explores the infrastructure and opportunities provided by the country to its biotech sector The government of Denmark is looking to attract Asian life science companies to invest in Denmark, especially in the field of R&D. In a recent media visit organized by Invest in Denmark, an investment promotion agency which is a part of the Ministry of Foreign Affairs, Denmark's health minister Mr Bertel Haarder told BioSpectrum that his government is working on several legislations aimed at attracting private investments from Asian countries, particularly from India and China. It is noteworthy that Denmark will hold the presidency of the European Union in the first half of 2012, and according to Mr Haarde, the health and life sciences industry is one of the top agendas of his government. Under the 'Health Innovation' plan, the Danish government is working on a legislation that would reduce the review period of clinical trials in Denmark from 30 days (fastest in Europe) to a minimum of seven days. Mr Haarder believes that setting up research centers in Denmark will help Indian companies get European approvals, as the infrastructure in Denmark does not allow excessive red tape. The Danish government is also working on a stronger legal framework for private-public partnership on research in healthcare sector. Their primary focus is on pharma, medtech and health technology. The government has reserved 41.1 billion DKR for the implementation of a new national hospital plan. Focus in the hospital plan is greater specialization and hence better treatment, more cost-efficient hospitals and better conditions for research and development. The government has set up a new body for e-health that will be responsible for governing the implementation of the national electronic patient record system by the end of 2013. â€œOne of the major attractions for foreign investors is our patient records. The Danish health registers enables researchers to monitor patients across time, regions and sector. The Danish Serum Institute is currently establishing a national bio bank, granting access to serum samples from all over the country,â€? said Mr Haarder. Medicon Valley cluster (Fact file) Population of approx 3.5 million. Companies with R&D and/or production: Approx 100 (red) biotech companies, 25 pharma companies (7 major) and 100 medtech companies. International companies with affiliates in Medicon Valley: More than 200 pharma companies and 170 medtech companies. Approx 40,000 employees in the private life sciencesector. Approx 10,000 life science researchers in the private and public life science sector. Twelve universities, five of which supply life science related educations. Approx 150,000 students, 45,000 of whom study life science. Approx 2,600 life science PhD students are enrolled at the universities of Copenhagen and Lund. Approx 7,000 life science university students graduate every year. Thirty two hospitals, 11 of which are university hospitals. Six science parks with a significant focus on life science. Six incubators, two of which have a significant focus on life science. More than 50 contract research organizations and contract manufacturing organizations. The Danish Council for Technology and Innovation has invested in a â€œStrategic Platform for Innovation and Research (SPIR)â€? within intelligent solutions for welfare service challenges. The SPIR is a partnership between a number of private companies and universities and aims at basic research. Funding for Danish health research on public facilities has more than doubled in the last decade. This is due to an increase in government funding, and success in taking home donations from European and American foundations such as the Novo Nordisk Foundation and the Lundbeck Foundation. Health research comprises 33 percent of Danish public research. The Danish government calls for Indian companies to set up operations in Denmark. â€œDenmark is a gateway to most part of Northern Europe. Copenhagen, being a major life sciences hub, is the ideal place for Asian companies to set up their North European headquarters. This will allow them to cover the market in Germany, Holland, Belgium and UK. The company tax rate here is only 25 percent and expatriates can benefit from a special tax regime,â€? said Rasmus BjÃ¸rnÃ¸, business development manager, Invest in Denmark. Clinical trial hub Approximately 1,000 clinical trials are approved and carried out every year in Denmark and about 20,000 Danes participate in clinical trials each year. According to Denmark's ministry of interior and health, Denmark conducts the highest number of clinical trials in Europe per million inhabitants. The country has a long tradition for patient and population registration. The Danish population is homogeneous with registered and easily accessible data, providing unique information on the patient population. Denmark has organized public health and death registries and a unique social security number system. Thus, data is available for studies, making Denmark particularly suited for epidemiological and clinical research. Some of the companies that chose Denmark for conducting clinical trials are: Pfizer: The effect of low-dose human growth hormone therapy in HIV infected patients on highly active antiretroviral therapy. GlaxoSmithKline: Human papilloma virus vaccine consistency and non-inferiority trial in young adult women. Astra Zeneca: Casodex vs Placebo in non-metastatic early prostate cancer. Merck: A comparison of two total hip replacements: hip resurfacing system versus Mallory-Head/Exeter. Novartis: A study to evaluate the effect of letrozole and tamoxifen on bone and lipids in postmenopausal women with breast cancer. Sanofi-Aventis: Simvastatin as an add-on treatment to copaxone for the treatment of relapsing multiple sclerosis. Eli Lilly & Co: Enzastaurin for patients with metastatic colorectal vancer. Highly qualified work force Approximately 1.8 million people live in the Greater Copenhagen Area, and if we include the Swedish side of the Medicon Valley, there are approximately three million people residing in this area. In total, they represent a workforce of roughly 1.5 million people of whom 42,000 are employed within the life sciences sector. Medicon Valley contains a highly educated work force, with 27 percent of people aged between 25 and 64 years holding tertiary degrees. It is also the best place to access one of Europe's most skilled talent pools. The Medicon valley Medicon Valley is a bi-national life sciences cluster that spans the island of Sealand in Eastern Denmark and the SkÃ¥ne region of Southern Sweden. It is one of Europe's strongest life science clusters with a large number of pharmaceutical, biotech and medical device companies and research institutions located within a very small geographical area. Local and international investors have provided the capital need for the continued growth of these companies. Together with specialized service providers such as different CROs, CMOs, consultants and patent attorneys, all the competences required to bring new and innovative products to the market are available. About 467 life sciences companies from across the world operate from this cluster. - Ashish Saraf (The writer was in Copenhagen at the invitation of Invest in Denmark)‘We will help India to tap the EU market’ Mr Freddy Svane, Ambassador, Royal Embassy of Denmark, New Delhi The Danish biotechnology industry is a major world player, particularly in the areas of enzymes, CNS research, diabetes and cancer research. Denmark, which boasts of the third largest commercial drug development pipeline in Europe, is continuously developing its research methodologies and is thus at the forefront of cutting edge biotech and pharma research. The excellent infrastructure provided by Denmark along with the various socio-economic incentives, being provided by the country, is attracting several foreign companies to set up their business in Denmark. The representative of the Kingdom of Denmark in India, Mr Freddy Svane, the Danish Ambassador to India, while speaking exclusively to BioSpectrum revealed that the world leader in clean technology is looking forward to collaborate with Indian firms to tread the path of success in biotechnology. Q What is the present scenario of co-operation between Denmark and India? Presently, we have more than 120 Danish companies that have set up their own establishments and are heavily investing in India. On the other hand, there are a lot of opportunities for Indian companies to grow in Denmark. I see many opportunities for interaction between the Governments of Denmark and India and also between the industries and the farmers of the two countries. We are doing a lot of work at the embassy along with our Trade Mission and our colleagues at Invest in Denmark in order to take the co-operation between the two countries to a higher level. Looking into the detailed collaboration that the Danish government and the Indian government currently have, we have a joint commission that sets out joint priorities and biotech is perhaps the most important priority. Q Why do you think companies from India should invest in Denmark? Denmark is a small country with only 5.4 to 5.5 million inhabitants. However, the number of clinical trials that we have conducted total to more than 2,000 global clinical trials in a year. The Danish government has decided to establish a fast track system that will drastically reduce the time required to obtain permits for clinical trials. We have the infrastructure in place which is important to developing a new drug. Denmark has a model called as a ‘flexicurity’ model that offers operational flexibility to Indian companies that are planning to set up business in Denmark. Corporate taxes are just about 25 percent, which is less than the European Union’s average. Denmark also has an English speaking population and a highly talented workforce. The government spends around 63.68 crore (€10 million) every year to provide infrastructure for life sciences, IT and clean tech sectors and also in education and in schemes such as the industrial-PhD program. It is fair to say that biotech companies in India, who want to come to Europe, have the perfect hub in the form of Denmark. We have the full range of products and services in place such as infrastructure, top institutions and a lot of biotech and medtech companies among others, which would attract the ambitious Indian biotech industry. Q Which Indian companies have invested in Denmark until now? During the last year, we had seen a large number of Indian investments been made in Denmark. Vimta labs, one of the leading clinical research organizations (CROs) of India and Aurobindo Pharma have just established their branch office, thus tapping into Europe by using Denmark as a hub. Also, a company called Ecron Acunova has invested in Denmark. We also have a strategic alliance with  Aurigene. We are seeing a large number of Indian firms showing their interest in the Danish market trying to explore the facilities that we have. —Saptarshi Chaudhuri in Bangalore ]]> <![CDATA[China dominates the billion-dollar club]]> https://biospectrumindia.com/news/95/1886/china-dominates-the-billion-dollar-club.html https://biospectrumindia.com/news/95/1886/china-dominates-the-billion-dollar-club.html Thu, 09 Jun 2011 11:54:00 +0530 Top 3 Countries China Country Rank Revenue CY 2010 % Share in 2010 1-3 13675.73 48.04 4-5 2488.81 8.74 6-10 3427.09 12.04 11-20 3804.46 13.37 Others 5068.37 17.81 Grand Total 28464.46 100 India Country Rank Revenue CY 2010 % Share in 2010 1-3 3854.06 20.97 4-5 1795.03 9.77 6-10 3045.04 16.57 11-20 3440.83 18.72 Others 6245.1 33.98 Grand Total 18380.06 100 Australia Country Rank Revenue CY 2010 % Share in 2010 1-3 8949.74 85.03 4-5 849.85 8.07 6-10 354.31 3.37 11-20 227.74 2.16 Others 143.53 1.36 Grand Total 10525.17 100 Legend: Country Rank: Publicly listed companies in the particular country; Revenue CY 2010: Revenue for the calender year 2010; % Share in 2010: Companies’ percentage share in the total revenue of publicly listed companies country wise China leads with five companies having revenues in excess of $1 billion. In fact, China’s No. 1 company, Sinopharm, which is also Asia’s No. 1 company for the second consecutive year in 2010 has grown by 48 percent and crossed the $10 billion revenue milestone. In addition to Sinopharm, other Chinese companies have also grown at a fast clip – North China Pharmaceutical (113 percent growth), Yunnan Baiyao Group (78 percent growth), and Shenzhen Neptunus Bioengineer grew by a remarkable 51 percent. This is a sampling of the boom that is happening in China. Compared to this, India, the other fast growing market in the region, has just two billion dollar companies among the country’s Top 20 list, however, a bunch of stable growing companies make up the rest of the industry. Australia has three companies over a billion dollars. And among other regions, it is likely that a couple of South Korean companies may cross this milestone in 2011. China, India, Australia continue to remain the Top 3 countries in the region, closely followed by South Korea and the others. The global pharma players have already recognized the opportunities available in China’s fast growing pharmaceutical market. Sanofi-Aventis expanded its R&D presence in China by opening a new research center. Eli Lilly announced plans to launch 15 new products in China over the next five years. And Medtronics started its operation in China. With an increase in investment and competition from multinationals, the local big pharma companies are preparing to face new challenges in the growing market. Consolidation is being adopted as one of the strategies by the local pharma companies to counter the competition from multinationals. ]]> <![CDATA[Mission: Recombinant FSH for fertility disorder]]> https://biospectrumindia.com/news/95/1798/mission-recombinant-fsh-for-fertility-disorder.html https://biospectrumindia.com/news/95/1798/mission-recombinant-fsh-for-fertility-disorder.html Mon, 09 May 2011 12:29:00 +0530 Deriving the maximum benefit from SBIRI funding, Bharat Serum & Vaccines has successfully managed to develop an indigenous product to treat fertility disorders in women Fertility disorders, for centuries, have been the cause of grave concern for women across the globe. Working in this direction, the Mumbai-based Bharat Serums & Vaccines  (BSVL) has produced the country's first  indigenously developed recombinant follicle stimulating hormone (FSH). This product is used extensively to treat fertility disorders in women. The timely availability of the Small Business Innovation Research Initiative (SBIRI) funding provided the much needed support to the company's in-house efforts and funds for developing and commercializing the product. It also encouraged the company to expand its R&D capabilities and capacity. The trademark name of the product is “FOLIGRAF” (r-hFSH), and it is a sterile freeze dried preparation of follicle stimulating hormone in genetically engineered Chinese hamster ovary (CHO) cells. The r-hFSH is a heteroadimeric glycoprotein consisting of two non-covalently linked alpha and beta subunits.  It is presented in lyophilized form of 75 and 150 IU/vial, intended for subcutaneous injection. Following intravenous administration, r-hFSH is distributed to the extra cellular fluid space with an initial half-life of around two hours and eliminated from the body with a terminal half-life of about one day. The steady state volume of distribution and total clearance are 10 l and 0.6 l/h, respectively. One-eighth of the r-hFSH dose is excreted in the urine. Following subcutaneous administration, the absolute bioavailability is about 70 percent. The study reports by the company concluded that r-hFSH is more effective than urinary FSH in terms of a lower total dose and a shorter treatment period needed to achieve pre-ovulatory conditions. Before the BSVL product was introduced in the market, all the recombinant products used to be imported in the finished form. The FOLIGRAF vial comes in a packing of 75IU *1's and 150IU*1's  with a cost of $41 (1800) and $79 (3500) respectively. Also the Recombinant FSH provides much better safety than the alternatives. It has an inherent advantage over the urinary derived FSH with no threat of transmission of viruses like HIV, HCV, HBsAg with r-FSH. Besides that the  product has batch to batch consistency due to well controlled manufacturing process. The Way Forward BSVL's vaccine would help to make the country self sufficient in terms of meeting the domestic requirements. Launched in September 2008, the product is currently available throughout India with an expected revenue of 170 million in 2010-11. BSVL has developed its competency in the areas of novel drug delivery systems (NDDS) and in development and purification of equine-based therapeutic products. With a focus on biopharmaceuticals, novel drug delivery systems and equine products, the company has made significant progress in R&D activities. To reduce the toxicity of the existing drugs significantly, the company is developing core competency into new drug delivery system. The different products that are in pipeline are liposomal doxorubicin (non pegylated), cisplatin emulsion, amphotericin B emulsion, amphotericin B lipid complex and propofol lipid free.  For future growth, BSVL is targeting the regulated markets for its products through technology licensing. Rahul Koul in New Delhi ]]> <![CDATA[Mission: Diagnosing kidney disorder]]> https://biospectrumindia.com/news/95/4402/mission-diagnosing-kidney-disorder.html https://biospectrumindia.com/news/95/4402/mission-diagnosing-kidney-disorder.html Mon, 09 May 2011 12:27:00 +0530 SBIRI funding helped Bigtec Labs to work towards the development of a sensor for the diagnosis of acute renal failure The acute kidney injury (AKI), a rapid loss of kidney function, is prevalent in a major chunk of the population in India. Generally, the diagnosis is done on the basis of lab findings such as elevated blood urea nitrogen and creatinine, or inability of the kidneys to produce sufficient amount of urine. Therefore, while putting efforts in creating a better diagnostic tool, Bangalore-based Bigtec Labs initiated work on the development of a sensor for proper diagnosis. This project was boosted by the Small Business Innovation Research Initiative (SBIRI) scheme of  the Department of Biotechnology (DBT). The project handled by Bigtec Labs  is for the development of  micro electromechanical systems (MEMS) based sensor for biomarker, neutrophil gelatinase associated lipocalin (NGAL), to diagnose acute kidney injury. The objective is to develop a rapid method to identify kidney injury in critical care situations. The problem with the existing alternatives is that these methods provide post facto information on kidney disease or are difficult to perform rapidly.  Founded in the year 2000, Bigtec has made significant progress in the last 10 years. The company has the core competencies ranging from the integration of chemistry, nano-biotechnology and MEMS to genetics and science/engineering,  allowing it to set the trend in medical diagnostics and chemical analysis. However, initially, the company found it difficult to attract  investments in the area of MEMS-based biosensors. Talking about the difficulties faced, Mr Chandrasekhar Nair, founder director, Bigtec Labs says, “We started the R&D company with the revenues from our software businesses as the area we were working on (MEMS-based biosensors) was at its infancy and we did not find appropriate venture capital support.” For this project, the SBIRI funding came as a major boost to the company's efforts. Being highly appreciative of the scheme, Mr Nair says, “As this was a high risk project, it was important to get some support for development and SBIRI funding was a good fit.” The company has also utilized the fundings from New Millennium Indian Technology Leadership Initiative (NMITLI), Biotechnology Industry Partnership Program  (BIPP).  The Way Forward Bigtec Labs' handheld point-of-care diagnostic equipment is designed to bring the power of bench-top laboratory equipment to the clinician by providing rapid, low-cost near-care diagnostics. The product is currently under development and can prove to be revolutionary if it comes in the market. Heading towards commercialization, the product is being further tested for clinical use. Since the product is first of its kind, the expectations are very high and may be the technology would open the way for diagnosis of other ailments too. Commenting on the future of the product, Mr Nair says, “The proof of concept prototype has been developed but lot more needs to be done in terms of ruggedizing the assay and validating it for clinical use.” Bigtec is presently involved in the development of detection systems for malaria, hepatitis B, hepatitis C, chikungunya, HIV and HPV. The company's platform is designed for the diagnosis of infectious diseases irrespective of whether the causative organisms are bacteria, virus, fungi or parasites. The company has also initiated discussions on H1N1 detections at transit points using company platform with a nodal government laboratory. Rahul Koul in New Delhi ]]> <![CDATA[Inbiopro Strides Ahead]]> https://biospectrumindia.com/news/95/2671/inbiopro-strides-ahead.html https://biospectrumindia.com/news/95/2671/inbiopro-strides-ahead.html Mon, 09 May 2011 12:25:00 +0530 Starting the business from a small apartment, with a staff of five, Inbiopro, in a span of three years has emerged as a hot biotechnology enterprise with its core strength in biosimilar development and process development services. Recently, Strides Arcolabs acquired 70 percent stake in the company (L-R) Mr Aditya Jhulka, Mr Sohang Chatterjee, Ms Kavitha Iyer Rodrigues—founders of Inbiopro Established on June 12, 2007, Inbiopro, with the vision to develop as a niche science and technology driven KPO organization, has not looked back since then. Marking a new chapter in its growth, Inbiopro has forged a new collaboration. Strides Acrolabs, one of India's leading integrated manufacturer and exporter of finished pharmaceutical dosage forms — both branded and generic — acquired 70 percent stake in Inbiopro. The deal will provide Strides with immediate access to a pipeline of eight products estimated to have global sales of over $28 billion (1,240,30 cr). Commercialization of these products is expected to begin in 2013. The acquisition will entail investment of 65 cr over a period of three years to be used for development and commercialization of products. Inbiopro was set up by a team of three biotech professionals – Mr Sohang Chatterjee, Ms Kavitha Iyer Rodrigues and Mr Aditya Jhulka. Mr Sohang Chatterjee, chairman and CEO of the company, a researcher from Cornell University, has an experience of seven years in setting up the process development lab for the Indian biotech customers at Millipore, India and a brief stint of nine months in Avesthagen. Ms Kavitha Iyer Rodrigues, director and chief of operations, having Masters in clinical microbiology and management, has five years experience at Biocon, then at Millipore and Avesthagen. Mr Aditya Jhulka, partner and business development-consultant, has worked with them at the consultants, McKinsey and then at Millipore and Avesthagen. The company received the initial funding of $1.5 million (around 6.5 cr) for a period of over three years from Accel partners. Speaking about the journey so far, Mrs Kavitha Iyer Rodrigues, director and chief of operations, Inbiopro says, “The company has progressed well since its start. Inbiopro has emerged to become a global biotechnology enterprise which has built partnerships based on its core strength of biosimilar development and process development services. The emphasis has always been on delivering quality with value engineering.” “At Inbiopro, we believe in the power of collaboration to create the biotech enterprises of the future. Through existing strategic alliances with leading universities in India, the US and leading pharma and biotech majors, we have demonstrated the success of our collaborative model. Now our collaboration with Strides in on the same line,” she adds. By the end of April, 2011, integration process will be completed and henceforth Inbiopro would be known as a Strides enterprise. The deal will have no impact on the management of Inbiopro, as the promoters will continue to be in charge of the operations of the company. With this deal, the distribution and launch of all the products of Inbiopro would  rest with Strides. This deal would give Inbiopro a major exposure with much needed large customer base. “We have gracefully moved ahead over the period of four years. Now with Strides as our partner,  we are committed to bringing biosimilars to market, beginning 2013. These will be manufactured with stringent quality guidelines and with platform technologies for expression,” claims Ms Iyer Rodrigues, speaking on the status of the company. “We are interested in biosimilar development. It is a fast growing market at greater than $20 billion (885,77 cr) outside of the European Union and the pegged growth is at 12-15 percent annually,” says Ms Iyer Rodrigues. “The Indian pharma majors realized that owning experienced and skilled R&D would be time consuming and setting up an inhouse team would not give them traction with respect to time. This is where we realized that the gap could be filled in with our experience in process development of biologicals,” she adds. Inbiopro offers a range of services that cover product development, assay development, process development, process validation, scale-up and transfer to manufacturing to its partners. In a short span of time, the company has established its competencies in areas such as 1) Process development;  characterization / scale up and validation projects for biologics, 2) Novel biomanufacturing platforms and technologies, 3) Novel biologics, including design or process modifications to existing proteins, 4) Biosimilar and biobetters. Inbiopro has undertaken partnerships with companies who are either discovery-based with a strong R&D background or with companies focused on biosimilar marketing and/or manufacturing. Having attained a stature in the Indian biotechnology market, the company aims to bring its eight products to market starting from 2013. The line up includes monoclonal antibodies and microbials and biobetters. “We would continue with our R&D work and focus on research and product development with platform technologies in the current space that we occupy over 6,500 sq ft of lab space. Our work on biobetters would also begin simultaneously as we build our pipeline,” says Ms Iyer Rodrigues. Elaborating on the future plans, Ms Iyer rodrigues says, “Our journey so far has seen us partner with major's like Lupin and Panacea Biotech. We are progressing well with full focus on product development with a pipeline of products, monoclonal antibodies and microbials that are ready for commercializing, beginning in 2013.” The company is also planning to increase its headcount from the current 22 to 35 in the next one year. With the aim of launching two products over 2012 and 2013, the company has already completed their animal trials, and would soon start clinical trials for the products in India. ]]> <![CDATA[India is the new global pharmaceutical hub]]> https://biospectrumindia.com/news/95/2739/india-is-the-new-global-pharmaceutical-hub.html https://biospectrumindia.com/news/95/2739/india-is-the-new-global-pharmaceutical-hub.html Mon, 09 May 2011 12:16:00 +0530 The Indian pharmaceutical industry is expected to reach $20 billion (88,820 crore) by 2015, which will make it one of the world's top 10 pharmaceuticals markets. According to the Associated Chambers of Commerce and Industry, India's clinical trials business will also reach approximately $1 billion (4441 crore) by 2011, further reinstating the subcontinent as one of the world's preferred destinations for clinical trials. With this increase, an immense need has emerged to address all aspects of pharmacovigilance in order to ensure that medical advances are delivered to patients, quickly and efficiently while protecting public health. In July 2010, the Ministry of Health and Family Welfare (MOHFW), India, launched a complete roadmap for pharmacovigilance in India under the Pharmacovigilance Programme of India (PvPI). The goal of this programme has been to provide safer medicines for the Indian population. There are many challenges facing the Pharmacovigilance Program of India, Dr Y K Gupta, national coordinator of the Pharmacovigilance Program of India (PvPI), while speaking in this regard, said that, “The sheer number of patients in India is quite sizeable and the issues sometimes conflict between the need to provide access to medicines versus the need to provide safer medicines.” Dr Gupta, a speaker at the Pharmacovigilance Summit India, also said, “The Ministry of Health and Family Welfare (MOHFW), India, is planning to address these challenges by allocating a budget head under the MOHFW budget.” Dr. Alexander Dodoo, president, International Society of Pharmacovigilance, will present a case study on Africa's experience in developing a robust pharmacovigilance system with limited resources at Pharmacovigilance Summit India. Pharmacovigilance Summit India, which will take place from 27-29 June 2011 in Mumbai, reflects the continually increasing importance of drug safety frameworks and approaches. The event will bring together regional and global experts to create a dialogue with local and international companies on setting up an advanced drug safety system to optimise resources, ensure quality and regulatory compliance. Biotech industry in India to reach 51,515 cr by 2017 A new report published by Global Industry Analysts  highlights that the Indian biotechnology industry will reach $11.6 billion (51,515 crore) by 2017. The Indian biotechnology industry was severely hit during the global monetary slump and this was evident from the plunge in the foreign exchange rate. The condition of the Indian biotech industry stabilized following the recession and it had shown significant rebound in the year 2010. The industry is expected to witness an extraordinary period of growth, with numerous drug developers worldwide looking to India as a low-cost destination for outsourcing their discovery and production work. The condition of the Indian biotech industry has stabilized following the recession and it is expected to witness an extraordinary period of growth, with numerous drug developers worldwide looking to India as a low-cost destination for outsourcing their discovery and production work. India had made a remarkable debut in the area of information technology and biotechnology is poised to be the next big thing for India on the global front. The Indian biotechnology industry, which is among the 12 leading biotech industries globally, presently accounts for a share of around two percent in the global biotech industry and is the third largest in Asia following Japan and South Korea. The Indian government, on its part, has been both proactive and supportive in driving innovation in the Indian biotechnology sector. The Indian government has vehemently been helping the industry by passing cordial regulations, providing grants for fledging companies and giving tax incentives among others. Exports are the highest revenue earners of the Indian biotech industry, reflecting the continued focus of Indian companies on the international markets. While bio-pharma, bioinformatics and bio-services represented a considerable chunk of the export market, the major bulk of revenues in the domestic market were generated from the bio-industrial and the bio-agriculture sector. The western part of India continues to dominate the Indian biotech industry, accounting for the largest share in terms of revenues. However, the southern region of India, which boasts of biotech hubs such as Bangalore and Hyderabad, has the largest number of companies in the country. ]]> <![CDATA['Bt Brinjal has been thoroughly tested and found to be safe']]> https://biospectrumindia.com/news/95/1061/bt-brinjal-has-been-thoroughly-tested-and-found-to-be-safe.html https://biospectrumindia.com/news/95/1061/bt-brinjal-has-been-thoroughly-tested-and-found-to-be-safe.html Mon, 09 May 2011 12:14:00 +0530 Dr Usha Barwale Zehr Chief technology officer Mahyco Research While progressive research and development has been the cornerstone of  Maharashtra Hybrid Seeds Company's (Mahyco) thumping success in the Indian Bt crop market, Dr Usha Barwale Zehr, chief technology officer, Mahyco Research, has been one of the key driving foces behind this success. Today she is responsible for research on plant biotechnology, technology transfer to farmers, utilization of new technologies and tools, including biotechnology for improving the quality and productivity of seeds and agriculture. In a conversation with BioSpectrum, Dr Barwale Zehr, throws light on Mahyco's progress so far in Bt food crops, her optimism for commercialization of these crops in India in the near future, and safety issues around Bt brinjal. Q In all, how many GM crops is Mahyco currently working on? What is the main focus of all the research projects? Dr Barwale Zehr: Currently, we are working on rice, wheat, cotton, okra, chilli, brinjal and cauliflower and our focus is on developing products which address the constraints faced by the farmers and these are insect tolerance, drought and salinity tolerance, fertilizer use efficiency, herbicide tolerance and disease tolerance. The goal is to have the products which make farming easier and improves productivity. Q What are the various traits and technologies the research team at Mahyco is working on as far as GM food crops are concerned? What are the demands for such traits/technologies amongst farmers? Dr Barwale Zehr: Broadly, we are working on technologies which address production constraints such as water availability, fertilizer, diseases and insects. All of these constraints affect production and make farming more variable. With water availability reducing daily, having crops which can produce more with less water is much needed. Similarly, in case of Bt brinjal, if the farmer can reduce 20+ pesticide sprays then the impact will be large on the farm, farmer and the environment. Q When do you hope to see market commercialization of these GM crops? Dr Barwale Zehr: For Bt brinjal which is the most advanced of our products, we are awaiting decision from the Government of India for commercial release. For the other traits in crops, product development and testing is ongoing, and we will begin the commercialization process in three years or so. Q What are the investments Mahyco made in R&D infrastructure and what is the annual investment it makes in R&D for biotech? Dr Barwale Zehr: We invest generally in the range of 10 percent of our revenue for research which includes biotech research. Since biotech and conventional research are so interlinked, we do not segregate the two. Q What has been Mahyco's progress and investment in Bt rice so far? What are the opportunities for Bt rice in a market like India? Dr Barwale Zehr: For Bt rice, we have been developing rice plants which control insects, primarily yellow stem borer and brown plant hopper. We have conducted trials with Bt rice which control stem borers as well as leaf folders. We have been investing in this research for the past seven years. Rice crop is affected by a number of stem borers and  Bt technology can provide control against this. Similar to what we have seen in the case of Bt cotton, we will see an impact on pesticide use, which will decline with Bt rice use. It will also increase productivity by controlling the damage caused by insects. Q Besides Monsanto, what are the various collaboration and partnership agreements Mahyco has made for GM crops? Dr Barwale Zehr: Mahyco is working extensively with a number of public and private entities, both in India and abroad, for sourcing technologies in priority areas and crops mentioned earlier. Some examples of such collaborations is the work we are doing with University of Delhi South Campus, Bose Institute, Assam Agricultural University. Q What are the activities of Desigen diagnostics in the space of Mahyco's Bt research? Dr Barwale Zehr: Desigen diagnostics is a unit of Mahyco which produces kits for detection of proteins including Bt proteins. The kits are available for various uses and are extensively used by companies engaged in Bt cotton as well as public and research facilities. Farmers also use products of Desigen to validate gene presence. Q In the light of the vehement opposition towards Bt food crops in India, what guidelines has the government put in place to assure the safety of Bt food crop consumers? Dr Barwale Zehr: The biosafety guidelines developed by the government of India are very stringent when it comes to safety and the products which are approved for commercialization must undergo all safety tests for release. GM crop was first commercialized in the US in the 1990s and in the food chain since then in large number of products. No biosafety concerns have come from the use of GM products. Q Public resistance to Bt Brinjal in India (over safety concerns) could be a deciding factor for GM food crops in India. What apprehensions does Mahyco have on this point? Dr Barwale Zehr: Bt brinjal has been thoroughly tested and found to be safe. Our system is more stringent than any other such system around the world and given the extensive studies conducted with the Bt protein (Cry1Ac), we see that this product will impact the farming community, consumers and the environment. We would like to see that the process followed for approval of any GM product is scientific, fact-based and as set out by the government. Q With this in view, is Mahyco lobbying with any industry forums to push forward the case of Bt food crops? Dr Barwale Zehr: Mahyco is engaged with creating awareness about biotechnology in general and what it can do for agriculture. We are members of the national associations which also undertake work of similar kind to create awareness and share information. Q What are the kind of programs and initiatives Mahyco is currently undertaking to bring  awareness about Bt food crops amongst farmers, consumer forums and the government? Dr Barwale Zehr: We have been involved with universities, farmer groups and workshops of various kinds to discuss and share information about Bt crops and the need for the same. We also participate in the programs being organized by industry associations as well as government agencies. Q Can you please throw light on the other expansion and investment plans of Mahcyo in the coming six months? Dr Barwale Zehr: Mahyco is committed to research-based product development for Indian agriculture. We continue to invest and work to understand the needs, and look at products suitable for that. Given the long product development cycle time for our products, the technologies that I mentioned above are areas that we will continue to progress on, in the coming six months. Nayantara Som from Dhawalwadi, Aurangabad ]]> <![CDATA['60 percent of our investment goes into agriculture']]> https://biospectrumindia.com/news/95/1581/60-percent-of-our-investment-goes-into-agriculture.html https://biospectrumindia.com/news/95/1581/60-percent-of-our-investment-goes-into-agriculture.html Mon, 09 May 2011 12:12:00 +0530 Mr Balvinder Singh Kalsi President - South Asia, E I DuPont India E I DuPont India, a wholly-owned subsidiary of E I DuPont, US has been fast expanding its operations in India, supported by the DuPont Knowledge Center and the DuPont Services Center. Agriculture and related segments have made significant contributions to DuPont India revenues and India is becoming a key market for the company's agriculture business worldwide. In an interview with BioSpectrum, Mr Balvinder Singh Kalsi, president-South Asia, E I DuPont India, shares his views on the importance of the Indian market, opposition to GM technology and many other issues. Q How strategic is the India market for DuPont? Mr Kalsi: India is definitely of strategic importance for DuPont but our focus here is to feed the millions. The food security being a core issue, we are committed to alleviate the fear of starvation. Because of huge agricultural needs, India holds key to the development of certain technologies. Being a science and research-based company, 60 percent of our investment goes into agriculture. We have invested significantly in India on both parameters—research and capital. The DuPont Knowledge Center at Hyderabad is an example of that. Q What is your opinion on opposition to genetically modified (GM) technology? Mr Kalsi: It is not about the GM technology only. It is about increasing the productivity with number of other techniques. The different aspects of the GM technology must be addressed. For that, we need a scientific debate on the subject to come to conclusions. But if people close their minds and stop listening, then it is very hard to make them understand about the benefits. Then, it becomes an issue. Having said that, it is also important to know that biotechnology is just an option among other options. We must remember that the primary interest is to keep away the pests and increase the yield. We need to make sure that more food is produced. Q Do you think that without commercialization, the investments in research of GM crops is a wastage? Mr Kalsi: I think we need to ponder over the fact that the farmers who toil hard out there in the field do not actually reap the benefits. They must also get the benefit of the GDP growth of eight-nine percent that is being talked about so often. Back in 2003, due to non-effectiveness of agrichemicals, farmers even refused to grow cotton. Since the introduction of Bt cotton, the entire scenario changed. Today 98-99 percent of the overall cotton crop is Bt Cotton. Farmers are wise enough and know the utilization of crops for the best outcome. Going by all these facts, the investments seem to be right because it is important to develop the technologies to increase productivity. Q What kind of growth are you expecting in the future? Mr Kalsi: We expect a sustainable growth of over 20 percent in the next two-four years time. Rahul Koul in New Delhi ]]> <![CDATA['We have developed a novel concept to treat diabetes']]> https://biospectrumindia.com/news/95/6045/we-have-developed-a-novel-concept-to-treat-diabetes.html https://biospectrumindia.com/news/95/6045/we-have-developed-a-novel-concept-to-treat-diabetes.html Mon, 09 May 2011 12:10:00 +0530 Dr Avadhesha Surolia Director, National Institute of Immunology, New Delhi New Delhi-based National Institute of Immunology (NII) recently made a breakthrough in research aimed at finding a cure for diabetes. The research team led by its director Dr Avadhesha Surolia developed innovative sustained insulin release formulation (SIRF), now under the process of transfer to the US-based pharma company, Extended Delivery Pharmaceuticals (EDP). Dr Surolia's pioneering contributions have strongly influenced research on structure and function of lectins, orientation and dynamics of cell surface carbohydrate receptors as well as drug and molecular design and their biotechnological applications. A winner of the prestigious S S Bhatnagar Award (1987), Dr Surolia in an exclusive interview with BioSpectrum, shared his thoughts and insights on the recent breakthrough in diabetes research, NII's role in drug discovery research, PPP and a host of other issues.  Q Tell us about the breakthrough achieved in diabetic research at  the NII? Why was Diabetes chosen as the focus of research over other areas? Dr Surolia: Diabetes is emerging as a global epidemic, with India, China and the US topping the list of countries being affected by both Type I and Type II diabetes. Diabetic patients need to administer themselves with insulin frequently to prevent high blood glucose excursion after ingestion of meals. The fear of pricking oneself multiple- times-a-day leads to low patient compliance and therefore raises complications such as diabetic cardiopathy and nephropathy. This has prompted interest in developing alternative, less invasive routes of delivery. Long acting insulin analogues achieve more constant glucose levels but suffered a setback due to induction of fasting hypoglycaemia. Thus the need for a suitable therapy, with the potential of improving the quality of patient life, still remains. In an attempt to address the issue of multiple injections and patient compliance, we have developed a novel concept wherein a sustained insulin release formulation (SIRF) is used for treatment of DM-I. Utilizing the currently available knowledge of protein folding and chemistry, we have developed a safe and long acting SIRF which releases insulin monomers at a steady rate. Initial studies done with a single injection of SIRF demonstrate a sustained and continuous release of biologically active monomers of insulin from the injected site, capable of regulating blood glucose excursions in animal model of diabetes for a prolonged period of time (in the range of 130-160 days). When compared to free daily insulin injections administered to diabetic rats, a single injection of SIRF, significantly lowered blood glucose levels, as well as reduced the incidence of secondary diabetic complications in diabetic animals. Q When was this research in diabetes initiated and approximately in what time period it would be ready for human use? Dr Surolia: Though the concept was conceived when I was still at the Indian Institute of Science, Bangalore, the research took shape only in early 2007, after I joined NII as director. The formulated SIRF, acts as a prodrug, from which viable insulin is released, which is absorbed into the bloodstream and thereby maintains a steady level of insulin concentration in the body, mimicking the physiological scenario, where normal individuals have a basal level of insulin in their blood. Interestingly, this is achieved without the use of a chemical or a device such as a pump or a patch. As with any innovation having tremendous clinical applicability, a minimum time frame of  6-7 years would be required for  thorough phase I, II and III studies to be completed. The work has been done only on small animals such as rats and mice in the laboratory. Therefore, it is still in its nascent stage and many experiments such as toxicological studies in higher animals needs to be done. These further experiments are routine and established experimental protocols which are followed for all drugs being screened for human usage. The experiments done in the lab are proof-of-concept and its usage in humans would be available after the phase trials are complete. Q What is the status of technology transfer and the royalty amount paid to the institute? Dr Surolia: The technology has been transferred to a US company by the name of Extended Delivery Pharmaceuticals, for a record amount. The execution of this tranfer is still in the process and thus right now we are unable to disclose the royalty amount. However, this is the highest amount that an Indian Institute has received from a company for a single innovation. Q Why does research in India often  fail to translate into products? What has been the contribution of NII towards the drug discovery research?  Dr Surolia: The major problem lies in the scientist coming out and taking risks. Bringing any research to the product stage requires ability to tackle failures and spending five times more effort, money and resources. People get intimidated by the failures and are unable to take on the challenge of taking a scientific research to the market. I could have just sat back after publishing my research work in a highly reputed PNAS journal. But instead I chose to involve myself and my team into the process of technology transfer and I am now actively involved with the company to see that the product does reach the masses and especially, the people of India. Unless you take the risk, success cannot be achieved. Moreover, our innovation support system is fragmented; it is still in the developing stage. We have good  policies, resources, ideas, mentorship, infrastructure and funding but we lack the alignment of these fundamental factors which are imperative to translate the research into product. NII has been actively engaged in drug discovery through various research activities which target biochemical pathways in the cell, genes involved in cell death, cell signaling and DNA synthesis. Q What is the importance of public-private partnership to bridge the gap between research institutes and the private industry in India? Are there any examples from NII in this direction? Dr Surolia: The current scenario of public-private partnership is really good and very aptly supported by agencies such as DBT, DST and CSIR. They have all been pro-actively involved in promoting these partnerships and generous funding is available both for the institutes and the industries. NII's participation in the phase II clinical trial of Rotavirus vaccine has been an excellent example of PPP with Bharat Biotech and other institutions such as DBT, AIIMS, CDC, SAS, NIH, Stanford University and PATH. Q According to you, what is required for strengthening the future growth of biotechnology industry? Dr Surolia: The key factors which will determine the sustenance of future growth of biotechnology industry include role of the government to form new and favorable policies like China and Europe, where policies for biotechnology promotion have already been enacted, availability of venture capital, building incubators in leading R&D institutions, effective commercialization strategies, public-private partnerships and embarking upon new research areas such as stem cell, nanobiotechnology, synthetic biology, biological sequestration of CO2 and environmental biotechnology. Rahul Koul in New Delhi ]]> <![CDATA['We will target biotech research market']]> https://biospectrumindia.com/news/95/2369/we-will-target-biotech-research-market.html https://biospectrumindia.com/news/95/2369/we-will-target-biotech-research-market.html Mon, 09 May 2011 12:08:00 +0530 Mr Sunit Trivedi, director BD Biosciences, India Becton Dickinson (BD) India's Biosciences division has come a long way since the establishment of India's first ever flow cytometry training center in the year 2003. BD has created its own market for cell analysis and flow cytometry under a very niche umbrella. BD Biosciences recently completed the acquisition of Accuri Cytometers, a US-based company that develops and manufactures personal flow cytometers for researchers. In an exclusive interview with BioSpectrum, Mr Sunit Trivedi, director, BD Biosciences India spoke about the opportunities, challenges, competition and future. Q What were the challenges BD  faced as a biosupplier? Among the challenges, the entire payment procedure and the tender process is very bureaucratic. Also, corruption is rooted deep inside the system. All these issues need proper attention and immediate redressal. The procurement process has to be simplified and made easier for the scientist to buy his product of choice. Also, there are certain products that have specific requirements for transportation. The products that need to be stored at -80 and -20 degree Celsius sometimes perish because of lack of proper cold storage facilities at the airports. The custom clearance must be quick for such products as it might perish in inappropriate conditions in two-three days. I also feel that pharma R&D should have more subsidies and rebate should be given on the 15 percent tax being paid by pharma companies doing R&D including CROs. Q How has the recent takeover of the Indian companies by the US majors helped? There is a need to take these takeovers positively. These companies have been acquired because they are doing something innovative at the local level. The taking of innovative technologies to the global level will certainly help the Indian economy to grow in the long run. Q What kind of acquisitions and new partnerships has BD done in the recent times? We keep acquiring companies from time to time. Recently, we acquired Accuri Cytometers, a US company targeting scientific people looking for personalized flow cytometers that are cheap and easy to use. The acquisition expands BD's presence into the emerging affordable personal flow cytometer space and helps expand the use of flow cytometer technology. Therefore, this takeover of Accuri which has a fantastic range of products with benefits such as compactness, easy-to-use, and affordability will address the concerns of this segment. The cost of high-end analyzer that costs around $100 thousand will now be cheaper by 50 percent. We will also run a corporate social responsibility (CSR) program for capacity and capability building. We plan to establish a much bigger training center from our existing one at Gurgaon and rope in the Masters level students of biotechnology into the program. The idea is to make the future researchers aware about the technology. Besides the flow cytometry coupled with reagents, we are also growing with our business unit, Pharmingen. The company has introduced more than 5,000 products addressing the needs of a broad spectrum of biomedical researchers. Actually, it is a continuous evolving program depending on the needs of the scientists. BD has also targeted the unique segment of plastic ware for in vitro fertilization. We have also tied up with National AIDS Control Organization (NACO) for the monitoring of  AIDS. Q What is your take on the competition? The core research market is getting stagnant. At the same time, the education market is quite big if the universities also start doing research. Since we cater to a very specific market, we enjoy complete monopoly over the segment of cell analysis and flow cytometry. During this business since last few years, we have established three Centres for Excellence (CoEs) at NCBS, Bangalore, Kolkatta University and CDRI Lucknow. Thats what makes us different from the others in the supplier space in which companies are generally considered as opportunistic and tender bidders. Q What are your views on the growth of  the biotech industry? The Indian biotechnology industry missed the bus for targeted growth as a lot of work in the form of  pharma R&D was lost to China. The hopes pinned on the new molecules have also not worked. The last few years have been prone to recession and it has also affected the growth of the industry. Since the aspirations of the biotech industry have not been fulfilled, I think that government has to put more efforts to boost the industry. The schemes such as BIPP and SBIRI by the Department of Biotechnology need to be utilized by more companies for the effective progress of the sector. Besides that, India is good at the generics and biosimilar areas. The biogeneric space has lots of good opportunities and it is said that around $80 million worth drugs are set to go off patent by 2020. Going by that the industry definitely needs a new innovative strategy to drive growth. Q What is the future outlook of your company? We certainly want to evolve. We will be targeting the huge biotechnology education research market and also focus on expanding our reach in training. The personalized flow cytometry and higher education market offer a huge opportunity for growth. We are trying to cater to this space with technology, affordability and easy to use products. I feel that India and China together can be huge markets for this segment. Besides the three existing CoEs, we are also looking forward to establish seven new CoEs in the next five years. I feel that there is still a wide market for analysis and diagnostics. Therefore, we would also be trying to tapthis vacant space. Rahul Koul in New Delhi ]]> <![CDATA['Lonza is investing Rs.405 cr in India']]> https://biospectrumindia.com/news/95/2729/lonza-is-investing-rs-405-cr-in-india.html https://biospectrumindia.com/news/95/2729/lonza-is-investing-rs-405-cr-in-india.html Mon, 09 May 2011 12:06:00 +0530 (L-R) Mr Lukas Utiger, executive VP, Head, bioscience division, Lonza and Dr Harry S Rathore, MD & country head, Lonza India Lonza is one of the leading suppliers to the pharmaceutical, healthcare and life science industries in the world. With a turnover of 129 billion (2.6 billion Swiss Francs) in 2010, it has emerged as the global leader in the production and support of active pharmaceutical ingredients. It has strong capabilities in large and small molecules, peptides, amino acids and niche bioproducts, which play an important role in the development of novel medicines and healthcare products. The company operates mainly in three divisions: life science ingredients, custom manufacturing and bioscience. In bioscience division, it makes the tools that life science customers use to discover, develop, make and test therapeutics. In this division its products range from cell culture and molecular biology tools for life science research to the media used in the production of therapeutics and tests for microbial detection. In life science ingredients division, it offers products used in nutrition and microbial control in selected industrial markets. In the custom manufacturing division, it is a partner to its pharmaceutical and biopharmaceutical customers for their manufacturing needs. As part of its new ventures and expansion plans in India, Lonza recently announced the launch of its upcoming R&D facility in 26 acres of land in Hyderabad. In an interview with BioSpectrum, Mr Lukas Utiger, executive vice president, Head of bioscience division, Lonza and Dr Harry S Rathore, managing director and country head, India, share their focus, future plans and outlook on the Indian market. Q Where do you see Lonza in the life science industry? Mr Utiger: In terms of business development, we have reached a mature stage with many developments in product businesses. On the chemical front, we have come up with biosimilars and on the application front, we are aiming at bioscience for pharmaceuticals. Our focus is selling, providing services, and R&D in India. Regenerative medicine is the future in life science industry. We focus on using regenerative medicine in areas like cardiovascular, brain health and metabolic related changes. Cell therapy will improve the quality of life. More than  220 million diabetic people worldwide were cured by human embryonic cells. By 2020, we aim to develop complete regenerative cure for diabetes and cardiovascular disease. We also aim to enter organ engineering by 2030. Q What do you see in terms of potential in the India market? Mr Utiger:  India is a country, which is rich in every aspect. We have lots of opportunities and it is well connected by air, sea and road. We also have well-educated people. In terms of business, the best aspect is the very high import tariffs. Compared to other countries, this attracts each and every company to this country. In terms of development in India, drug discovery has to develop more. Currently, Lonza is investing $90 million (405 cr) in India. We have recently launched a new R&D center in 26 acres of land at Genome Valley in Hyderabad. The knowledge center will function as a major global R&D think tank for Lonza's biosciences. Q What do you consider as the USP of your products? Dr Harry S Rathore: The Lonza brand in itself is the unique selling proposition. The quality and brand come as complementary to each other. The size as well as financial stability are the other major strengths of our company. Q What do you consider as challenges for Lonza in India? Dr Harry S Rathore: There is a dire need for single window approval. We are planning to develop a new facility in the SEZ area and the entire procedure itself takes time. We are capable of completing our project by 2012 but the entire delay is with approvals, time and people. Hunt for talent is also one of the major challenges we need to address. Q What is your investment plan for 2011? Mr Utiger: We have a budget of around 1500 cr (300 million Swiss Francs) per year. In the biopharma sector, we are focusing on very substantial investment, in which, major part goes to Asia. India will also be our special focus. Bioscience is another sector where we will invest more. The manufacturing cost factor entirely depends on the demands of the customer. Q Where do you see Lonza 10 years down the lane? Dr Harry S Rathore: The company sees good growth 10 years down the lane. We would develop further in the area of nutrition. Docosahexaenoic acid (DHA), an omega-3 fatty acid would be the key product and we are also looking at new compounds. With new technologies, we would create new platforms in the manufacturing area. The company would get closer to customers in several areas and we would also take a step forward in nutrition and biopharma. Suchitra Pillai in Hyderabad ]]> <![CDATA[Organic farming picks up in India]]> https://biospectrumindia.com/news/95/5488/organic-farming-picks-up-in-india.html https://biospectrumindia.com/news/95/5488/organic-farming-picks-up-in-india.html Mon, 09 May 2011 12:03:00 +0530 India has emerged as a major producer of organic food. The area under organic produce is likely to grow by 25-35 percent in the next few years Organic agriculture has a very decisive role to play in the current world scenario, since food security and food safety are highly challenged. In its report, 'Organic Agriculture and Food Security', the United Nations Food and Agricultural Organization (FAO) has identified organic agriculture as a priority area for addressing challenges associated with both local and global food security. The FAO proclaims that organic farming is the single window solution for fighting hunger and food scarcity and tackling climate change, a venture which is beneficial for the farmers, the consumers and the environment alike. The importance of organic agriculture and demand for organic products are increasing throughout the world at a phenomenal rate. In the past few years, the expanding global market for organic foods has seen an annual growth rate of 15 to 40 percent. This growth is more prominent in Europe, United States and Japan. Market appreciation of organic products has gone up tremendously, owing to the enhanced awareness for healthy food among consumers worldwide. The demand for organic produce is increasing in India as well. A study done by the Morarka Foundation reveals that the issues of adulteration in food, growing incomes of middle class, evolution of modern retail formats, private sector initiatives in agribusiness, technological innovations in agriculture and food and growing awareness about organic products are creating a lot of demand for organic produce in urban India. The major domestic markets include, Bangalore, Chennai, Delhi, Hyderabad, Mumbai, Jaipur, Pune and Coimbatore. â€œIn these markets, there is 100 percent growth in the number of outlets such as - exclusive organic outlets (there has been an increase from 100 stores to 300 in the last one year), retail outlets (increase from 500 shops to 1,000 in the last one year) and farmer/producer owned outlets (doubled from about 1,000 to 2,000 in the last one year),â€? says Dr P V S M Gouri, advisor, Organic Products, Agricultural and Processed Food Products Export Development Authority (APEDA). Business Opportunities Organic adoption and Certification facilitation Post harvest processing, storage and packaging CO2 fumigation storage chambers Value chain development and retailing Input production Organic seed production Integrated community biogas and manure production units in villages with network of service and maintenance providing agencies Organic Milk is a very attractive commodity and needs marketing links Organic oil is another potential subject Soybean by products (meal, oil and lecithin) Herbal dyes and essential oils Medicinal and herbal plants and their processed forms Source: National Center of Organic Farming (NCOF) The demand for green agricultural products stimulates the growth of the green input market as well. In other words, if there is demand in the market for organically produced farm products, it will encourage farmers to implement the organic farming practices and also to use green inputs into agriculture, such as bio-fertilizers, bio-pesticides, compost, farm yard manure (FYM) and green manure among others. Based on the gross cropped area in India and recommended doses of bio-fertilizers, there will be a potential demand for biofertilizers, such as rhizobium, azotobactors, azospirillium, BGA, and phosphate solubilizer. With the ever increasing demand, the organic producers are finding it difficult to match up to the expectations. There are many initiatives and efforts that are being taken to augment organic agriculture at various levels and different places. However, most of these initiatives have failed to make their impact as they are scattered and isolated.The central government has been promoting the production and use of bio-fertilizers to make it popular. The government has initiated a project called the “National Project on Development and Use of Biofertilizers,” for this purpose. The main objectives of this project include, production and distribution of bio fertilizers (BFs), developing standards for different BFs and quality control, releasing of grants for setting up BF units and training and publicity. Indian Organic Vital Stats Total organic area-1,08,650 hectares Total projects-2099 Number of grower groups-919 Total organic farmers-548,045 Total certified production-17.11 lakh tons Number of processors- 427 Total export-58,408 tons Value of export-$112 mn (525.49 crore) Number of exporters – 29 Source: National Centre of Organic Farming To build a green agricultural input market in India, it is not sufficient to incentivize production but there is also a need to focus efforts in creating market demand. Collaborative and concerted efforts between input producers, farmers, the agriculture scientific community, government officials and traders at different level i.e., at the central government, state government, district and village level could give the required strategic attention to organic agriculture. Only collaborative efforts would create avenues for marketing organic produce internally and expedite the necessary linkages for enhancing India's  presence in the international organic products market. Mr Sarvadaman Patel, president, Organic Farming Association of India (OFAI), while sharing the activities of his association in promoting organic farming, says, “Currently, we are having 2,500-3,000 members involved in organic produce that represents various zones in the country. Besides focusing on the practical side of organic farming, we are also promoting marketing of the products. We hold conventions from time to time for getting innovative ideas. We ask farmers to bring these products and we help them with the expertise.” OFAI has been set up by the organic farming community, environmentalists and social activists in order to promote organic farming, lobby for its official adoption by the Indian government and assist farmers who are dependent on chemicals to convert to organic systems. OFAI aims to help organize farm-households and families, who are engaged in organic farming and other connected activities, into a recognizable entity that will effectively represent their interests at the local, state, regional and national levels. Similarly, Mumbai-based Institute of Natural Organic Agriculture (INORA), has been actively playing a key role in research, development and promotion of organic farm management and manufacturing of permitted organic farming inputs, organic farming certification systems, earthworm vermitech for biological solid and in liquid waste composting, treatment and recycling. INORA has its own clientele and has also opened stores to cater to their needs. Challenges Quality and Certification credibility Food Safety Demand for Supply Myth to Change from Conventional farming GMO Contamination Source: Agricultural and Processed Food Products Export Development Authority (APEDA) Sharing her thoughts on the government schemes for promoting organic farming, Ms Manjushree Tadvalkar, CEO, INORA says, “The schemes by the government are related to the promotion of biopesticides, biofertilizers, production of vermicompost, liquid manure and irrigation. Besides that, there is a subsidy on green manure, biofertilizers and pesticides. We try to act as the connecting link between the farmers and the government on this.” “Organic farming holds tremendous importance in the ecology. Organically made food has wider perspective, wider environmental use, and that too without disturbing the ecological balance of nature. As in the last 50 years, soil fertility has decreased by a huge extent, it is high time to realize the importance of organic farming,” adds Ms Manjushree. Market scenario India is best known as an exporter of organic tea and also has great export potential for many other products like litchi, fruits, cotton, healthcare, skincare and lifestyle products among others. This holds promise for organic producers and industries to tap the market, which is growing steadily in the domestic market as compared to the export market. India has about 3.95 million hectares of land (0.96 million hectares cultivable land and the remaining forest area) under organic farming and ranks 33 in world, in terms of area under organic farming, and is placed at 88 position, in terms of the ratio of agricultural land under organic crop to total farming area. “Madhya Pradesh has the highest area under organic farming with 1.1 million hectares (52 percent) followed by Maharashtra with 0.96 million hectares (33.6 percent), Orissa at third with 0.67 million hectares (9.7 percent) followed by Uttrakhand and Sikkim,” said  Prof M K Salooja, director, School of Agriculture, Indira Gandhi National Open University (IGNOU), while speaking at ‘Organic Conclave' organized by ASSOCHAM in December, last year. Says Dr A K Yadav, director, National Centre of Organic Farming, “About 5.5 lakh farmers (over 900 groups) are actively involved in organic farming throughout the country. India has over 400 processors with certified production capacity of over 17 lakh tons. India has internally established acclaimed certification systems both for the export and the domestic market. Currently, the country has 20 certification bodies to choose from. Apart from this, India also has a new farmer-centric certification system known as the Participatory Guarantee System. Organic farming in India has grown 25-fold in the past seven years because of combined efforts of farmers, NGOs, government interventions and push from other market forces.”    Good practices in all the areas of organic farming, certification, accreditation of agencies, traceability, food safety, quality management, safe processing and product development will further strengthen organic food production and its safety. In addition to catering to the domestic market, India exports 70 percent of its organic products to Europe, followed by the US (20 percent), South–East Asian countries (five percent), Japan (3-5 percent). India exported 135 organic products under 15 categories during 2009 valued at $112 million (525.49 crore). Among the products exported, cotton is at the top followed by basmati rice and honey. The demand for Indian organic products is increasing in Europe. There are 294 organic exporters in India. To provide a boost to the organic products' exports, the government has decided to launch an awareness program amongst farmers and offer subsidies. APEDA will be launching a drive of 100 percent organic products exports from the current level of  530 crore per annum to 1,000 crore by 2012. APEDA  is offering subsidies to encourage the marginal and poor farmers' community to undergo an extensive change from existing chemical farming to organic farming. Some of the other efforts towards promotion of organic exports include, attempts to collaborate with all the major organic products importing countries. The initiatives from various government agencies, active participation of farmers' group and NGOs at different levels and awareness about the advantages of using organic produce will create a huge market potential for organic farming in India. Narayan Kulkarni in Bangalore (Inputs from Rahul Koul) ]]> <![CDATA[Companies leverage on Nanomedicine]]> https://biospectrumindia.com/news/95/2688/companies-leverage-on-nanomedicine.html https://biospectrumindia.com/news/95/2688/companies-leverage-on-nanomedicine.html Mon, 09 May 2011 11:58:00 +0530 Nanomedicine makes use of nanoparticles for developing newer drug delivery systems against cancer, diabetes, fungal infections and viral infections The remarkable properties of various nanomaterials have caught the attention of scientists, researchers, and manufacturers alike. The global market for nanotechnology is expected to reach $1 trillion by 2015. Ongoing research activities harness its potential for the overall betterment of the society. â€œNanobiotechnology is an emerging area that provides unlimited opportunities in product development. This new technology speeds up diagnostic processes; develops accurate engineered nanotools for the prevention, diagnosis and treatment of diseases; facilitates early detection of cancer, heart and other rare diseases; enhances drug discovery; enables targeted drug delivery; opens doors for nanomedicine by imparting stem cell applications; paves way for effective diagnosis and treatment of cardiovascular disease; and strengthens tissue engineering by providing bioactive nanomaterials for smart implantation,â€? says Mr Puneet Mehrotra, director, Nano Science and Technology Consortium (NSTC). With over 250 corporate and institutional members, NSTC is one-of-its-kind organization in India. The NSTC focuses on technology transfer; facilitating global and local business opportunities, training, education, publications and collaborative processes in nanotechnology. The Industry Indian companies like Lifecare Innovations, Dabur Research Foundation and Imgenex India; and research institutes such as Nichi-In Center for Regenerative Medicine (NCRM) are focused on developing nanomedicine. Nanomedicine makes use of nanoparticles for developing newer drug delivery systems against cancer, diabetes, fungal infections and viral infections. Since its inception in 2000, Haryana-based Lifecare Innovations has been working on nano drugs. The company has a number of products at different stages of development. Their first product, Fungisome, a nanosomal amphotericin B, is India's first nano drug. The drug offered the opportunity to make a precision targeted delivery of encapsulated amphotericin B to life-threatening fungal infections. â€œIn 2003, we started work on application of its proprietary oral sustained release nanotechnology â€“ the first application being anti-TB drugs combinations. The preclinical studies were completed four-years ago, but the Drug Controller General of India (DCGI) took three years to understand and grant the company to conduct phase I clinical trial. Promising results of the nano drugs for TB delineated that the long duration sustained release would help reduce dosing frequency from daily to two-three times a month, which would have understandable advantages of logistics, socio-economical and treatment economics. It is a celebrated technology in R&D circles but industry response is lukewarm as TB patients are predominantly served by government-controlled programs and industry is reluctant to invest is neglected diseases,â€? says Dr Jitendra N Verma, managing director, Lifecare Innovations. Applications of Nanobiotechnology Nanopharmaceutical Drug Discovery Gold nanoparticles and quantum dots are used for tracking molecular properties in livening cells. Nanolaser helps to halt the progression of neurodegenerative diseases. Nanoparticles enable cell targeting with attached small molecules. Drug Delivery Protects drug against premature degradation Enables sustained release of a drug to maintain a long-lasting drug concentration Diminishes adverse side-effects Enhances efficacy of a drug by delivering the drug to the diseased tissue. Drug Production Tablet design Tablet production system Tablet compression Nanomedicine Nanodiagnostic devices Nanosurgery tools Nanooncology Nanoneurology Nanocardiology Nanoorthopedics Nanoophthalmology In treatment of infections Tissue engineering In natural musculoskeletal tissues Nanofibrous scaffolds are used in bones, cartilages, muscles and ligaments â€œThe experience of sustained Release Nano-TB, however, encouraged more applications. We are working as part of five-organization consortium including ICGEB, New Delhi; BITS, Pilani; and University of Toronto under ISTP Canada-DBT India collaborative program where we are responsible for developing single dose sustained release oral drug for malaria treatment. We have nano-antiinfectives, anti-cancer and anti-inflammatory drugs, and pain killers in pipeline. In the next three-to-five years, we aim to bring these novel drugs to the patients,â€? adds Dr Verma. Dabur Research Foundation (DRF), a contract research organization based in Uttar Pradesh, has developed and standardized electron and fluorescence microscopy-based methods, coupled with bioanalytical techniques like HPLC and LC/MS to quantitate intracellular uptake and localization of targeted nanoparticle devices. This technique enables it to evaluate the intracellular accumulation of drugs and its sub-cellular distribution and localization. This in-turn helps to form a correlation with the biological activity of nano-delivery systems. DRF currently offers these models as a service to pharma and biotech industry. â€œDRF developed and launched nanotech-based chemotherapy in India. This nanoscale drug delivery system for the widely used anti-cancer agent, paclitaxel, was the first-of-its-kind in India. The paclitaxel nano drug is a cremophor-free water soluble formulation and is indicated as a safe therapy for advanced breast, non-small cell lung and ovarian cancers,â€? says Dr Manu Jaggi, director (R&D), Dabur Research Foundation.DRF's nanoparticle drug delivery devices such as Nanoxel enable the therapy to take a preferential course to cancerous cells and directly interact with tumor causing agents. This opens a larger window for anti-tumor activity. It also ensures that the patient receives full measure of the therapy while limiting the adverse side-effects and toxicity affected by the drug,” adds Dr Jaggi. Orissa-based biotech company Imgenex India is a leading developer of monoclonal antibodies in India. The company has been using nano particles in developing biosimilars, and has a strong program in the development of biosimilar therapeutic monoclonal antibodies (mAbs). “Imgenex India plans to improve the efficacy of the biosimilar antibodies by encapsulating them in nanoparticles and make them as biobetters or biosuperiors, which may be defined as antibodies that are aimed at similar targets and carry similar indications as existing products, but are with improved stability and dosage,” says Mr Sujay Singh, CEO and president, Imgenex India. “The protein and peptide drugs can exploit the development of innovative systems which provide for controlled, prolonged or targeted delivery, improved stability during storage and delivery, reduced adverse effects, increased bioavailability, improved patient compliance and allow for administration through the desired route while coping with cost-containment therapeutic protocols. These can be achieved using nanotechnology. Delivery of osteoclast inhibitory peptides using nanotechnology-based platform for the treatment of osteoporosis is one of the major projects at Imgenex India,” adds Mr Singh. Imgenex India is also working on formulation of special media supplement to induce pluripotent stem cells (iPS cells) from adult somatic cells. The company plans to add nanoparticle-loaded recombinant transcription factor proteins that are required for iPS cell generation to the cell culture media. These nanoparticles will allow controlled release of transcription factors into the culture media for induction and maintenance of iPS cells from adult somatic cells. This project is being carried out by a SBIRI funding from the Department of Biology, India, in collaboration with Dr Sanjeeb Sahoo from Institute of Life Sciences, Orissa. This technology will provide the ability to create patient specific iPS cells for understanding disease progression and screen for therapeutic strategies. "DRF's Nanoparticle drug delivery devices such as Nanoxel enable the therapy to take a preferential course to cancerous cells and directly interact with tumor causing agents" — Dr Manu Jaggi director (R&D), Dabur Research Foundation Chennai-based Nichi-In Center for Regenerative Medicine (NCRM) too has been working on developing a nanomaterial-based artificial cornea. NCRM is an Indo-Japan joint venture carrying out research, training and clinical applications-protocol development in regenerative medicine, with emphasis on stem cells, progenitor cells and autologous adult cells with regenerative capability. NCRM is also developing a nanomaterial and processing methodology for lab-based expansion of hematopoietic stem cells, which would help blood cancer patients. Commenting on NCRM's initiatives on nanobiotech, Dr Samuel JK Abraham, director, NCRM says, “NCRM has been working with approximately 270 different nanomaterials and technologies in specialties such as ophthalmology (corneal stem cell regeneration), orthopedics (cartilage injury repair), and hematology (expansion of hematopoietic stem cells). Recently NCRM along with our global headquarters – Nichi-In International, Japan – and Kawamura Institute of Chemical Research, Japan, have filed a joint patent application on a nano-sheet which promotes the in vitro expansion of corneal endothelial precursors and their application in vivo, in treating corneal blindness.” In the anti-aging research we are working on developing nano-polymer scaffolds to sustain the cells in zero-gravity and micro-gravity so that the damages to cells during lab expansion or storage for longer periods could be minimized so as to preserve their youthfulness,” adds Dr Abraham. Opportunities India has a huge potential to market nanotech products. However, careful and selective investments in nanotechnology can certainly catalyze the country's economic development and in near future, could pave way for its transformation into a developed nation. Nanomedicine has bright growth prospects in India with its related research being carried out in various academic and scientific institution. Research includes designing of drugs with greater degree of cell specificity, improved therapeutic efficacy of delivered drug as well as to minimize its cytotoxicity-related adverse effects. "Delivery of osteoclast inhibitory peptides using nanotechnology-based platform for the treatment of osteoporosis is the one of the major projects at Imgenex India" — Mr Sujay Singh CEO and president, Imgenex India Similarly, diagnostics is another area of research that is investigated extensively with nanoparticle for early detection of the disease thereby providing better prognosis. The undergoing research in the field of nanomedicine mainly explores its application to provide targeted drug therapy, diagnostics, tissue regeneration, cell culture, biosensors and other tools in the field of molecular biology. Besides public sector R&D institutions, various companies in India are researching on nanomedicine, especially in the development of newer drug delivery systems against cancer, diabetes, fungal infections, viral infections and for gene therapy. “The pharmaceutical, biotechnology and biomedical companies in India are concentrating on nano-based platforms like fullerenes, nanotubes, quantum dots, nanopores, dendrimers, liposomes, magnetic nanoprobes and radio-controlled  nanoparticles for developing smarter therapeutic and diagnostic modalities,” observes Mr Singh of Imgenex India. India has made significant inroads into the field of nanomedicine in the last decade. This includes areas such as nano-diagnostics (in-vitro and in-vivo sensing and imaging systems capable of quantifying and visualizing the levels of various bio-molecules at the cellular level), targeted drug delivery; and cell and tissue repair (synthetic growth of tissue by targeted delivery). “Other areas include development of nano-bioceramics that can repair bone and tissue; and aerosol sprays that use nanoparticles to deliver drugs for the treatment of lung cancer. This ability to manipulate biological systems at the molecular level and the scientific initiatives taken thus far will certainly contribute to medical advances in the years to come,” says Dr Jaggi of DRF. Challenges Even though India has several opportunities in the area of nanomedicine, the country faces some challenges in the form of funding, IP and understanding the technology when it comes to global market. “From my personal opinion, India is still in infancy with the nanomaterial development. When compared to the developed nations, we did not start basic research in nanomaterials well in advance and due to lack of such original technologies in materials, processes and methodologies we need to depend on already patented materials and methodologies to accomplish end-product developments,” says Dr Abraham of NCRM. “Indian researchers and industry both are glued to the generics and biosimiliars bandwagon that does not allow them to think anew and come up with a blockbuster. Regulatory regime also does not improve the situation. On one hand, new things that deserve approvals are hard to understand and so gets delayed, while on the other hand novel drug delivery system in the name of generics get clearance without requisite clinical trials. Same is the situation with clinicians. Any new drug introduced by an MNC despite having well-known and documented narrow activity becomes a drug of choice. For India to take advantage of its full potential of novel technologies, this mindset needs to change, ” says Dr Verma of Lifecare Innovations. According to Dr Verma one important change required is in the area of IP protection. Drugs, biotherapeutics, vaccines and other healthcare products take around 10-15 years from concept to commercialization because of requisite trials and resultant multi-stage regulatory clearance process, whereas non-medical innovations can hit the market immediately. This long duration consumes major part of the patent life that serves as huge disincentive to develop new drugs. If newer solutions are expected, patent life must be granted for a post-marketing period.  Much of the work done until now has been focused on applications of nanomedicine in drug discovery and drug delivery. Sharing his thoughts on the advantages of nanomedicine, Dr Jaggi of DRF says “the miniaturization of analytical, diagnostic procedures is another important area which results in performing analytical procedures in the lab on a much smaller scale. In the long-term, nanomedicine is expected to provide the ability to undertake in vivo diagnostics coupled with targeted and focused therapy.” Looking at the opportunities and potential applications of nanobiotechnology, the Government of India has been encouraging the growth of the sector by funding nanobiotech projects under various programs of DBT, DST, DSIR and ICMR. The Karnataka government too is promoting nanobiotechnology and has allocated 14 acres of land to set up the Indian Institute of Nano Science and Technology (IINST) in Bangalore to strengthen nanobiotech R&D. Such government initiatives will help India to move ahead in the nanobiotech race. ]]> <![CDATA[Enzymes to boost food industry]]> https://biospectrumindia.com/news/95/1016/enzymes-to-boost-food-industry.html https://biospectrumindia.com/news/95/1016/enzymes-to-boost-food-industry.html Mon, 09 May 2011 11:56:00 +0530 With food fortification fast becoming one of the growing industry segments, enzymes emerge winners Though the Universal Declaration of Human Rights, established by the United Nations (UN) in 1948, identifies nutrition as a fundamental human right, malnutrition remains the biggest contributor to child mortality in the world. According to the Food and Agriculture Organization of the United Nations, there were nearly 217 million undernourished people in India at the beginning of the last decade. The scenario has not changed much. Fighting malnutrition, mostly through fortifying foods with micronutrients is one of the world's highest priority health issues.  Researchers, worldwide, are working towards creating  maximum nutrients in the minimum possible amount of food. In the recent years, enzymes have emerged as the best possible solution for the Indian food industry. Using enzymes and genetic engineering, one can design plants and foods for the future depending on the requirements of the agriculture and nutritional sector. According to Dr Rakesh Tuli, executive director, National Agri-Food Biotechnology Institute (NABI), Mohali “One can design plants or food as per the need and requirement of the society. We can design strategic crosses to express desired molecules in plants through pathway engineering and similarly, we can also create foods that have specific type of desired molecules. For example: Withania Somnifera (Indian ginseng) has different qualities acting as anti-tumor, antioxidant, antistroke, immunostimulant and immuno modulatory. But its real purpose remains confusing. Hence, with the help of genetic engineering, we are trying to make the plant develop in such a way that it is good for one and not for other. This helps in defining a perfect purpose for it and thereby understanding the wealth of the plant.” Novozymes is one such company which has been working on this pathway for the last five years. “Enzymes are the future sustainable solutions for the Indian food industry. We have developed enzyme application in food segment successfully for the past five years. With the right collaborations one can develop the enzyme applications in new segments too,” said Henrik Bisgaard, senior director, Innovation office, Novozymes, Denmark, at a seminar organized by Association of Biotechnology Led Enterprises (ABLE) and Novozymes. One of the leading companies in the enzymes segment, Novozymes creates bio-industrial products by using enzymes for various applications. The seminar discussed sustainable solutions for the Indian food industry using biotechnological tools. "There is a dire need for availability of the right kind of food and adequate food. We should make food enriched with micro nutrients like vitamins and minerals. The biscuit industry is something which we can focus on by fortifying it with nutrients as it reaches every nook and corner of the country." — Ms Vinita Bali CEO, Britannia Right from fortification to preservation, enzymes have wide ranging applications. “We can increase the shelf life of fruits, bread, vegetables using these methods. We can also increase antioxidants in plants, thereby, discouraging that the insects that feed on them. For example: The shelf life of tomato can be increased by 10 days using antisense gene of ACC oxidase from banana. Relatives of wheat with high content of iron and zinc, micronutrient fortification of banana, increasing the level of carbohydrate and proteins, creation of soft wheat from hard ones; should be brought forward,” says Dr Tuli. NABI has already done projects on high micronutrient grains, low phytic acid grains, high accumulation of anti-oxidants, high amylose and low amylopectic grains and soft grain wheat with high yield for biscuit and cookies. The need for a proper solution like this is a must for the food industry, especially in a country like India. According to studies, two out of three children and women have iron deficiency in India. The UN aims to reduce the number of women who die during childbirth by three-fourth and the number of children who die before the age of five by two-third, by 2015. The fortification of food with nutrients is needed to meet the objective. According to Dr K Madhavan Nair, deputy director, biophysics division, National Institute of Nutrition, an arm of Indian Council of Medical Research (ICMR) based at Hyderabad, “We should enhance the genetic selection and production practices. The changes should be implemented right from the seed or root stage in crops to meet the requirements of the society. Methods to produce rice with improved iron content and other nutrients should be brought forward. The fortification of food with micro nutrients like iron, iodine, zinc, vitamins, copper is the need of the hour. One needs to come forward to support the cause of solving the issues like bio availability, absorption and utilization.” The companies are all set to welcome the new methods of food fortification and its benefits for the industry and people. According to Dr Shovan Ganguli, platform director, bioscience, nutrition and health, Hindustan Lever, “the food industry would surely grow with the change. It will also provide more job opportunities in the food processing industry. But safety still remains an issue which needs to be properly addressed before moving ahead.” Hindustan Lever has products like Green tea in this segment. Britannia, one of the leading companies in the food market also claimed that food fortification is the need of the hour. “There is a dire need for availability of the right kind of food and adequate food. We should make food enriched with micro nutrients like vitamins and minerals. The biscuit industry is something which we can focus on by fortifying it with nutrients as it reaches every nook and corner of the country. According to figures, nearly 60 percent of school going students are anemic in India,” adds Ms Vinita Bali, CEO, Britannia. “Food processing companies and biotech companies should come together to protect the health and nutritional needs of the weaker sections of the society. We are closely associated with the National Institute of Nutrition on this aspect. We have come up with iron-rich biscuits but the main problem is that only nine percent of the food consumption is of branded packaged food, the rest 91 percent is from the generally available non-branded food products. The major issue would only be solved once the entire industry starts on it together,” Ms Bali states, while speaking on the trends in health food. Even when the need and positive aspects of usage of biotechnological tools as sustainable solutions for the Indian food industry is preached on, the issue of safety still remains  a major concern for Indians. The researchers are still not sure on the after-effects of the continuous intake of the genetically modified crops or food. With the National Biotechnology Regulatory Authority Bill (NBRAI)  yet to be discussed in the parliament, all eyes are on it, for now. Suchitra Pillai in Bangalore ]]> <![CDATA[ICMR looks for partners to commercialize research]]> https://biospectrumindia.com/news/95/2714/icmr-looks-for-partners-to-commercialize-research.html https://biospectrumindia.com/news/95/2714/icmr-looks-for-partners-to-commercialize-research.html Mon, 09 May 2011 11:50:00 +0530 The Indian Council for Medical Research (ICMR), New Delhi, is looking out for private partners to commercialize various compounds and technologies. With an aim  to promote Public Private Partnerships, the premier medical regulatory authority invited applications from various companies to commercialize products. The different compounds that are being looked upon for commercialization include a herbal insecticidal composition, an antineoplastic compound, a herbal composition useful as larvicide agent against dengue vector, use of formulation comprising human SP-D for therapy and prevention of sexually transmitted infection including HIV. The technologies that are being put for industrial collaborations are the Dot ELISA for diagnosis of sequelae to Chlamydia trachomatis infection in women using Chlamydial Heat Shock Protein-60,  An Immunodiagnostic Reagent Macrofilricidal Agents for Filariasis Control, A cyclic lipopeptide of Bacillus subtilis ssp. subtilis (VCRC- B471) with potential to kill mosquito stages, A process for pot staining of sputum for detection of Acid fast Bacilli. The Indian patents have been already filed for few of the technologies by the Intellectual Property Right (IPR) cell of the ICMR. With such kind of innovative products and technologies made available, the private industry is expected to react positively to promote them. IMB scientists find cause of rare skin cancer Institute of Medical Biology (IMB) scientists under the Agency of Science, Technology and Research (A*STAR) in Singapore are part of an international team of researchers who became the first in the world to discover the gene behind a rare skin cancer which grows rapidly for a few weeks before healing spontaneously, according to the research published in Nature Genetics. The peculiar behaviour of this rare self-healing cancer, called multiple self-healing squamous epithelioma (MSSE), was discovered to be caused by a failure in the gene called TGFBR1, which is a key component of a signalling pathway that can also be impaired in other cancers. This pathway is widely regarded in the field as a potential target for therapeutic intervention in cancer treatment. Dr David Goudie, a clinical genetics consultant at Dundee University and a long term specialist in MSSE, said, “The unusual behaviour of this tumor has baffled scientists for over 40 years, so we are excited to have discovered the genetic faults that cause the disease. Understanding how tumors that lack TGFBR1 behave will surely help us to predict the clinical effects of drugs that target these cancer-promoting or cancer-inhibiting signals.” ]]> <![CDATA[Generic version of Allegra launched]]> https://biospectrumindia.com/news/95/3623/generic-version-of-allegra-launched.html https://biospectrumindia.com/news/95/3623/generic-version-of-allegra-launched.html Mon, 09 May 2011 11:49:00 +0530 Indian drug major Dr Reddy's Laboratories has launched its over-the-counter (OTC) fexofenadine HCl tablets.The Food & Drug Administration (FDA) approved Dr Reddy's Abbreviated New Drug Application (ANDA) for fexofenadine HCl tablets on April 12, 2011. Dr Reddy's will market the product under store brand labels in the U.S. market. The products are bioequivalent versions of sanofi-aventis' Allegra tablets which received Rx-to-OTC switch approval from the FDA on January 24, 2011.The fexofenadine HCl Rx market had brand and generic sales of approximately $452 million (2,012 crore) for the 12 months ending December 31, 2010 according to IMS Health. Ranbaxy launches generic olanzapine In a major step aimed at the treatment of  schizophrenia in adults, India's largest pharmaceutical company, Ranbaxy Laboratories announced the launch of olanzapine tablets, the generic version of zyprexa in Spain. Ranbaxy will be introducing olanzapine tablets 2.5 mg, 5 mg, 7.5 mg and 10 mg and also orodispersables in 5 mg and 10 mg. According to IMS data of 2010, zyprexa is the innovator product of Eli Lilly. Ranbaxy received necessary regulatory approvals from the Spanish Health Authorities to manufacture and market olanzapine in Spain and is expected to launch the product on day-1, following patent expiry. Olanzapine is an atypical antipsychotic, and is indicated for the treatment of schizophrenia in adults. The product is effective in maintaining the clinical improvement during continuation therapy in patients who have shown an initial positive response. Olanzapine is also indicated for the treatment of moderate to severe manic episodes and prevents their recurrence. It is also indicated for the treatment of several bipolar disorders. MSD and Sun Pharma collaborate Merck Sharp & Dohme Corporation (MSD), India, entered into a strategic partnership with Sun Pharmaceutical Industries to co-market its diabetes drugs in India. Sitagliptin and sitagliptin plus metformin are the two diabetes drugs which would be marketed by Sun Pharmaceuticals in India. Under the partnership arrangement, Sun Pharmaceutical Industries will have the rights to market, promote and distribute sitagliptin and sitagliptin plus metformin only in India under different brand names. This India-specfic partnership agreement aims at delivering treatment benefits of DPP4 inhibitors to an expanded base of diabetic patients. Keeping in mind the increasing number of diabetic patients in the country, this partnership will focus on the interest of patients of type-2 diabetes in India. ]]> <![CDATA[Mr Amar Lulla, Cipla's director, passes away]]> https://biospectrumindia.com/news/95/2544/mr-amar-lulla-ciplas-director-passes-away.html https://biospectrumindia.com/news/95/2544/mr-amar-lulla-ciplas-director-passes-away.html Mon, 09 May 2011 11:48:00 +0530 Amar Lulla, the former joint managing director of Cipla, passed away after a prolonged battle against cancer. Mr Lulla, who was aged 63, worked in Cipla for thirty five years before exiting the company on December 13, 2010. However, he continued to be the non-executive director of  the firm. Mr Lulla was selected to the board of directors in 1990 and was appointed as the joint managing director in 2000. He helped Cipla develop a strong footing in the international market and was instrumental in setting up state-of-the art facilities at Goa and Indore. Mr M K Hamied, joint managing director of Cipla, while speaking about the departed soul, said that, “It is a very tragic moment. We were privileged to have him in Cipla working in various capacities for over 35 years. His contribution has been simply pivotal. We all pray that his soul may rest in peace and our hearts go out to all his family members.” GEAC's Anand Kumar resigns One of the prominent members of the Genetic Engineering Approval Committee (GEAC), Dr P Anand Kumar, has quit from the panel of experts during the last week of March, 2011. Dr Kumar is currently the director of National Research Centre on Plant Biotechnology (NRCPB), New Delhi. GEAC is the apex body constituted by the Ministry of Environment and Forests, Government of India, under the ‘Rules for Manufacture, Use, Import, Export and Storage of Hazardous Microorganisms/Genetically Engineered Organisms or Cells 1989'. Dr Kumar's resignation came after an appeal was made by the co-chair of the panel to members that they should quit if they had a conflict of interest. The repeated political interference in functioning of the GEAC is among the various reasons behind the move. Dr Kumar, had in the last year, authored a report prepared by six science academies that which had favored the immediate release of Bt brinjal. The 30 member GEAC is headed by Mr M. F Farooqui, additional secretary, Ministry of Environment & Forestry (MoEF), Government of India. The committee members are mostly  experts who specialize in different verticals of agri-biotechnology. Father of Biomedical Engineering Elmer L Gaden, who did his BS, MS and finally PhD in engineering in the year 1949 at the University of Virginia School of Engineering and Applied Science, is widely known as the “father of biochemical engineering.” Professor Gaden's ground-breaking research formed the basis for the mass production of a wide range of antibiotics, including penicillin. Professor Gaden was named the 2009 winner of the Fritz J. and Dolores H. Russ Prize, which is considered by many as the equivalent of a Nobel Prize for engineering. Professor Gaden's interest in using biological processes to generate chemicals, led him to publish a lot of literature. ]]> <![CDATA[CEL-SCI to commence phase III trial]]> https://biospectrumindia.com/news/95/1556/cel-sci-to-commence-phase-iii-trial.html https://biospectrumindia.com/news/95/1556/cel-sci-to-commence-phase-iii-trial.html Mon, 09 May 2011 11:45:00 +0530 Vienna-based, CEL-SCI Corporation, announced that it received approval to begin enrollment of patients in its phase III clinical trial of multikine in India from the Directorate General of Health Services Office of Drug Controller General (India) â€“ the Indian equivalent of the FDA. India is an important country for this clinical trial, which is being held in nine countries because about 15 of the 48 clinical centers for this global trial will be located in India and also because India has the greatest number of head and neck cancer cases in the world. It is expected that patient enrollment in India will be about four-six times faster than would be possible in US clinical centers. The global phase III trial for multikine was started in the United States in late December 2010. CEL-SCI expects to commence the trial in other countries around the world within the next 30-60 days. Multikine is the company's flagship immunotherapy developed as a first-line standard of care in the treatment of head and neck cancer. Phase II clinical trials of multikine demonstrated that the product was safe and well-tolerated and eliminated tumors in 12 percent of the subjects within less than a month into treatment. The multikine treatment regimen was also shown to kill, on average, about half of the cancer cells in the subjects' tumors before the start of standard therapy. Max Neeman enrols 15,000 for phase IV metabolic disorder trial India's leading CRO Max Neeman meets enrollment and timeline of 15,000 patients for a large, phase IV metabolic disorder trial across 1,200 sites throughout India. As a leading Indian CRO, the company has completed multiple Phase IV studies for global sponsors with thousands of patients successfully enrolled. A 30,000 patient enrollment study across 1,500 sites is currently in-process with four more in the pipeline. Current ph IV success and activities are due to a specific business model Max Neeman created for such 'Observational studies' based on over 10 years of experience. Segments of the business model include: zonal stratification of >1000 sites and SOPs to improve quality of patient data retrieved in large studies. More than 30 CSRs have been developed to date. The prevalence of diabetes in India is second only to China with 50.8 million people diagnosed with the disease and expected to rise steeply in the coming years. More large ph IV studies are predicted and Max Neeman is prepared with a ph IV strategy that is a combination of operational excellence (via Six Sigma practices), dedicated and trained project management teams, flexible delivery models, a customized approach and integrated technology. All these combine to deliver positive results on a customer's objective in a swift and cost effective manner. GVK extends USFDA GOBIOM license GVK Biosciences extended its Clinical Biomarker Database (GOBIOM) license to the Biomarker Qualification Group of the US Food and Drug Administration (USFDA). The GOBIOM database, which has the latest and updated information on all the biomarkers reported in various clinical and preclinical studies, will be of enormous use to the USFDA in its Biomarker Qualification Process. The GOBIOM database is a comprehensive collection of all the clinically evaluated, exploratory and preclinical biomarkers that are associated with different therapeutic areas reported in global clinical trials and in clinical and preclinical studies. GOBIOM contains information on 12,000 biomarkers comprising biochemical, genomic, imaging, metabolite, cellular and physiological markers with multiple data points covering experimental, analytical, clinical and statistical data with their qualifications under different medical interventions. SIRO Clinpharm expands in Asia SIRO Clinpharm, a leading Indian Contract Research Organization (CRO), announced the launch of its operations in Malaysia. SIRO had announced in 2010, strategic alliances with CROs in South Korea and Taiwan. Malaysia is a highly developed and fast growing clinical trials destination and this attracted SIRO to expand its reach. SIRO began its operation in India back in the year 1996 and this has made SIRO one of India's most experienced CROs. India comes together to improve healthcare To address the issue of lack of healthcare access in India, a conference 'Healthcare Access Week' (April 4-9, 2011) was organized by India Health Progress in Mumbai. This conference highlighted the various incremental steps taken by healthcare organizations towards better healthcare access for the Indian patients by bringing together all the stakeholders for a unified cause. Representatives from various healthcare organizations, NGOs and pharmaceutical companies shared their contributions towards the improvement of healthcare in India. Although considerable growth trajectories have been marked by the Indian economy, the healthcare system is still ailing and more than 65 percent of the Indian population does not have access to quality healthcare. Speaking on the occasion Mr Ranga Iyer, healthcare consultant and former MD, Wyeth, said, â€œWe need to join hands and raise our voice towards the â€œlack of access to healthcare in India so that the healthcare condition of our country can be improved. I hope today's initiative will act as a catalyst towards motivating everyone for taking initiatives for better healthcare system in India.â€? Given India's enormous economic strides, since the early 1990s, continued healthcare inaccessibility is particularly disappointing. Although around 70 percent of Indians live in rural and semi-urban areas, nearly 80 percent of healthcare facilities and medical personnel are based in cities and other urban centers. The objective of this conference was to appreciate and showcase the initiatives undertaken to provide healthcare access to all, thus creating an environment for developing improved policy framework for healthcare in India. Furthermore, this initiative would act as a catalyst towards encouraging everyone for taking more initiatives for better healthcare in India. New stem cell bank at Hyderabad With stem cells gaining awareness among the public, more and more research organizations are coming forward with new initiatives in this area. Recently, the launch of a new stem cell bank and processing center for therapy at Hyderabad by Tran-Scell Biologics & Pacific Hospitals, during the BioAsia 2011 event was one among those. Incorporated in 2009, Tran-Scell Biologics was founded for cord blood private banking service at Hyderabad, India, at first. It entered this new era of health industry with a bold and unique business model. Tran-Scell proposes to integrate the chain of business vertically, beginning with stem cell preservation, processing, and up to clinical applications by being a third party processed clinical grade stem cell provider. Now in 2011, it has come up with new stem cell bank and processing center at Jubilee Hills, Hyderabad. The facility currently has cord blood stem cell banking service initiated as well as introduced onto the market. Tran-Scell collects processes and stores the new born baby's cord blood stem cells for a specified period, which may later be a potential source material for debilitating disease condition. Cord blood is believed to be a major source of stem cells for transplantation worldwide, which can be used to treat major diseases like cancers and bone marrow failure syndromes, inborn errors of metabolism, blood disorders and immune deficiencies also with a great promise in the treatment of neural injury, diabetes, heart conditions. With the aim of adding value to the birth experiences, the company offers second chances to those who may face life threatening diseases in future. India to start GM rubber trials soon The Rubber Research Institute of India (RRII) based out of Kottayam will soon commence field trials of genetically modified (GM) rubber in the state of Maharashtra. The field trial has been approved by the Genetic Engineering Approval Committee (GEAC) under the Union Ministry of Forests and Environment (MoFE) during its meeting late last year. Rubber Board Chairman, Ms Sheela Thomas, said that field trials will be conducted at Chethakkai Thombikandam in Kerala and in Dapchari Thane in Maharashtra, and will last for 14 years. On the other hand, MoFE stressed that the trials would be conducted in closely controlled environment, not in areas where commercial rubber trees are planted. Agilent launches Headspace Sampler for GC applications Agilent Technologies, the world's premier measurement company and a technology leader in chemical analysis, life sciences introduced a headspace instrument for gas chromatography (GC) sample analysis, the 7697A Headspace Sampler. Based on Agilent's automatic liquid sampler (ALS) technology, the 7697A Headspace Sampler features superior performance without loss or degradation of volatile components found in the gas portion of partitioned GC samples. Headspace sampling allows the introduction of volatile compounds, from virtually any matrix, directly into a GC or GC/MS instrument. The technique is relatively simple when compared to other injection techniques, such as purge and trap, and keeps instruments cleaner than the standard liquid injection. The 7697A Headspace Sampler is available as both a high-end sampler with 111-vial capacity or as a mid-range unit with 12-vial capacity. Cole-Parmer announces partnership with picoSpin PicoSpin has engaged Cole-Parmer to sell their new breakthrough spectrometry product internationally. The exclusive rights apply to the picoSpin Benchtop NMR Spectrometer, an innovative and disruptive technology that combines low price and a compact footprint, with true spectroscopic capability. With this combination of sought-after features, research labs and educators now have affordable access to a dedicated NMR spectrometer. Cole-Parmer has been a leading global source of laboratory and industrial fluid handling products, instrumentation, equipment, and supplies since 1955. â€œYou can deploy multiple units within a factory to continuously monitor process fluids and control them all from a web browser anywhere in the world. Students can experience NMR hands-on in chemistry lab courses and in their research projects,â€? says Dr John Price, president and chief scientist of picoSpin, LLC. â€? Evolva to buy out R&D partner Emerging biotech firm, Evolva, has proposed to acquire San Francisco-based Abunda Nutrition. Evolva had colloborated with Abunda in 2009 in order to develop the latter's  next-generation nutritional ingredients. The collaboration will also concentrate on advancing highly purified forms of Stevia, which is a natural high intensity sweetener that is manufactured by the fermentation of yeast. The fermentation methodology helps in processing and refining of Stevia plants and allows pure Stevia components to be produced. Evolva has proposed to obtain full ownership of certain additional development-stage compounds that are useful in cardiovascular health along with Stevia. Venus Remedies wins TQM award Venus Remedies, a leading research-based pharma company, recently bagged the prestigious international award, QC-100 TQM (Total Quality Management), in Gold Category. The award has come in recognition of the company's commitment to quality, system efficiency, leadership, technology and innovation. Venus is the only pharma company from India to have won this prestigious award, which was  given by Business Initiative Directions (BID) International Quality Convention 2011 held in Geneva on March 7, 2011. Around 59 countries from around the globe participated in different categories in these awards. Sun Pharma, Merck in joint venture US-based drug major, Merck, and India-based, Sun Pharma, have entered into a collaboration to jointly develop, manufacture and commercialize new combinations of innovative branded generics in the emerging markets. The partnership combines Sun Pharma's proven track record of leadership and expertise in rapid, innovative product development using Sun Pharma Advanced Research Company's proprietary platform technologies, and Sun Pharma's world-class manufacturing network. The venture will also benefit from Merck's clinical development and registration expertise and a broad, geographic commercial footprint. Indo-Spain JV to make enzymes Kilpest India has come forward for a joint venture with two Spainish firms, Biotools B & M Labs  and its Madrid-based spin-off company, 2B Blackbio Biotech, in order to manufacture enzymes and reagents that are important in the field of molecular biology. Kilpest is one of India's oldest pesticide formulating company that started operations in Madhya Pradesh during the 1970s. This venture will also manufacture molecular diagnostic kits based on Spanish patented technology for several diseases, including tuberculosis diagnostic, malaria and dengue among others. DRL technology center in UK opens Indian drug major Dr Reddy's Laboratories announced the opening of its newly expanded Chirotech Technology Center, at Cambridge Science Park, UK where Chirotech has been based for the last 20 years. The new 33,000 sq ft facility is purpose built for laboratories and offices and has been fitted to Dr Reddy's specific requirements for chemistry, biology and analytics. The additional capacity will help facilitate an initial doubling of scientific staff in Chirotech while providing additional capacity in the future. It will help strengthen core capabilities in biocatalysis and chemocatalysis, build capabilities in fast growing segments like Activated mPEGs and peptides, and allow development of other areas of expertise in chemistry. Takeda sues DRL for Dexilant Dr Reddy's Laboratories has been sued by global pharma giant, Takeda Pharmaceutical, in the US for allegedly infringing upon its patent coverage of gastroesophageal reflux disease drug Dexilant (dexlansoprazole delayed release capsules). Takeda alleged that Dr Reddy's and its US subsidiary have infringed US patent numbers through the submission of an abbreviated new drug application seeking approval to market generic versions of Dexilant, a patented drug of Takeda. US sales of dexilant is estimated to be worth $261 million (1,161.97 crore). Calyx Chemicals files DRHP for IPO Calyx Chemicals and Pharmaceuticals has filed the Draft Red Herring Prospectus  with Securities and Exchange Board of India and the stock exchanges for an IPO of 68,30,000 equity shares at face value of 10 for each equity share. The issue also includes an employee reservation portion of 50,000 equity shares. The IPO, will be made through the book building process wherein not more than 50 percent of the issue shall be allocated on a proportionate basis to qualified institutional buyers, not less than 15 percent of the Issue shall be available for allocation to non-institutional bidders and not less than 35 percent of the Issue shall be available for allocation to retail individual bidders Gene Logic offers academic price for ASCENTA Gene Logic, the leading provider of reference gene expression database solutions, based at Gaithersburg, Maryland, and an Ocimum Biosolutions company, announced that user licenses of its award-winning ASCENTA System are now offered at special academic pricing to all academic and non-profit organizations to encourage innovation in the industry. ASCENTA is web-based and was developed to simplify access and information retrieval from BioExpress, Gene Logic's proprietary database. ASCENTA makes it possible for researchers to quickly identify and prioritize drug targets and biomarkers. Suven Life Sciences gets US FDA approval Suven Life Sciences announced that it received the US health regulator approval for its manufacturing facility at Pashamylaram, in Andhra Pradesh. It had undergone US FDA  renewal inspection at its Unit III, the facility at Pashamylaram, near Hyderabad. The unit manufactures and supplies active pharmaceutical ingredients (bulk drugs) and intermediates under current good manufacturing practice (CGMP). Based on the inspection and the review, the US FDA classified the Suven facility as acceptable for manufacture and supply of active pharmaceutical ingredients and intermediates. 300 crore allocated by DBT for GM crops The department of biotechnology (DBT) has allocated 300 crore for conducting research on genetically-modified (GM) crops. India presently boasts of around 400 research centers that are conducting research, of which 200 are part of the DBT grant. The effort is to improve the productivity of a variety of GM crops, according to S R Rao, advisor, DBT, Government of India. DBT is spearheading several policy-related developments, which would shape the future of GM foods in India, including Food Safety and Standard Act. However, there is a lot of debate on the labelling policy of GM foods and inclusion of GM food trade issues in the foreign trade policy. GM technology only an option: Experts To address the challenges on food security, DuPont, convened a panel of experts to discuss  solutions on feeding India. The ‘Global Collaboratory' event was held on April 8, 2011. The panel included emminent personalities such as Dr M S Swaminathan, chairman, M S Swaminathan Research Foundation, Dr Swapan Kumar Datta , deputy director general (crop science), Indian Council of Agricultural Research, Pradip Mazumdar, CEO & director, CropLife India and  Ajay Jakhar, agriculturalist and chairman, Bharat Krishak Samaj among others. Glenmark Pharma in distribution pact with Canada's IDC Glenmark Pharmaceuticals, a leading player in dermatology and drug discovery, has entered into an exclusive arrangement with Immanence-IDC, a leading Canadian company for the distribution of their high-end anti-aging cosmeceutical range of products. The agreement will span across eight operating countries for Glenmark. The countries are India, Brazil, Mexico, South Africa, Egypt, Vietnam, Malaysia and Thailand. This will mark Glenmark's presence in this fast growing specialized dermatology segment which is growing at a rapid pace across emerging economies. Commenting on this development, Mr Arvind Vasudeva, Chief Operating Officer, Glenmark Pharmaceuticals Limited mentions, “This association marks a new beginning for us in one of the fastest growing segments in dermatology. With emerging economies registering good economic growth in the past decade, this niche segment has been witnessing a transformation and there is a significant need for these high-end products across our operating countries” He added “The IDC cosmeceutical range of products are based on a solid scientific foundation and have been successfully launched in few countries. This association will enable us to consolidate our leadership position in dermatology across operating branded generic markets” ]]> <![CDATA[India's biotech brands make a splash]]> https://biospectrumindia.com/news/95/1729/indias-biotech-brands-make-a-splash.html https://biospectrumindia.com/news/95/1729/indias-biotech-brands-make-a-splash.html Mon, 09 May 2011 11:39:00 +0530 In the mid-1990s, one of India's current biotech icon was a dejected man. He had just exited a joint venture with his friend in Hyderabad, which was supplying some high tech equipments to the country's armed forces. To get over the gloom he went on a vacation to the Silicon Valley in the US. And to kill boredom, he attended a conference on recombinant vaccines. This got him interested and he tried to talk to the leading biotech company in the San Francisco Bay Area to license the rDNA technology. The company's managers ridiculed him for even thinking about making such high tech products in India. However, Mr Varaprasad Rao did not take the slight easily, came back to India, enlisted the help of scientists at the Center for Cellular and Molecular Biology (CCMB), Hyderabad. In 1997, his company, Shantha Biotechnics launched the first India-made rDNA product, a hepatitis-B vaccine, much to the amazement of the world. India's biotech entrepreneurs have not looked back since then. From a country which imported all its modern biological drugs, India is now a net exporter of these products. The May 2011 BioSpectrum cover story, “Biotech Drugs: The Wave Arrives” is a tribute to the long and difficult journey made by a set of intrepid entrepreneurs against all odds. They went about their mission to make the world sit up and notice them in a methodical manner. Currently, India's regulators have approved the use of 20 recombinant DNA products in the domestic market. There are 15 Indian companies manufacturing these. The surpluses are exported to over 100 countries. The world doubted India's ability to make rDNA products. But now, more than half of the global requirement for hepatitis-B vaccine is supplied by a handful of Indian biotech companies. The best is yet to come. There are 72 products in the pipeline.  While we rejoice at this Indian success story, the biotech industry, globally, has provided yet another breakthrough to treat hepatitis-C, caused by contaminated blood. The US regulator, FDA has almost approved, as I write this editorial in late April, Boceprevir, the hepatitis-C drug from Merck & Co. This advanced drug, called as protease inhibitor, produces an enzyme that blocks the replication of the hepatitis-C virus and thus controls its spread. Merck's drug is expected to improve treatment efficiency by more than 30 percent and also cut down the medication time from the current one-year regiment to a few months. The US regulator is also likely to approve a similar hepatitis-C drug, Telaprevir from Vertex Pharmaceuticals. Millions of people die every year due to hepatitis-C infection and the numbers are more in developing nations. The drug could be soon available in India too. There is some more good news. After two years of lull, India's life science companies are heading to the financial market with their initial public offering (IPO). Three companies, Intas Pharma, Arch Pharmalabs and Calyx Chemicals, have filed their red herring prospectus with the regulator, paving the way for the public offering. This indicates the confidence of the industry as well a shift in investor interest away from the traditional sectors. Many biotech companies could benefit from the investor interest as they could use the current positive investment climate to raise resources for boosting their research and manufacturing capabilities. Narayanan Suresh Group Editor sureshn@cybermedia.co.in ]]> <![CDATA[Superbug Scare: Do we really need to fear?]]> https://biospectrumindia.com/news/95/1637/superbug-scare-do-we-really-need-to-fear.html https://biospectrumindia.com/news/95/1637/superbug-scare-do-we-really-need-to-fear.html Mon, 09 May 2011 11:37:00 +0530 Recently, there was a furore over a report by the British journal, The Lancet, which claimed that there was a presence of a superbug in New Delhi's water bodies. BioSpectrum tries to find out whether it is just a hoax created to attack the Indian medical tourism, or do we really need to take the situation seriously On April 06, 2011, British medical journal, The Lancet published an online article titled ‘Dissemination of  New Delhi Metallo Beta Lactamase -1” (NDM-1) Positive Bacteria in the New Delhi environment and its implications for human health: an environmental point prevalence.' The article was based on the results of  reported testing of the biological samples in the form of swabs of Indian seepage water and tap water in the UK. The report led to a huge controversy surrounding the presence of the antibiotic resistant superbug. The Indian government was quick to debunk the report. It maintained that the capital's drinking water is safe and questioned the credibility of the study. According to the official statement by the Ministry of Health and Family Welfare, Government of India, the study is unsupported by any clinical  and epidemiological evidence and also does not highlight the unstable character of the isolates. “The environmental presence of NDM-1 gene carrying bacteria is not a significant finding since there is no clinical or epidemiological linkage of this finding in the study area as given in the publication.  The fact that patients respond well to medical  and post surgical antibiotic treatment indicates that NDM-1 is not a significant problem in the country,” stated the statement issued by the Ministry. However, following the outcry from the public and civil society, the government decided to set up a committee to carry out research into the basics of NDM-1.The WHO will be assisting the Indian government in the  research that is expected to reveal if the superbug is a health threat or not. The director general (DG) of Indian Council for Medical research (ICMR), Dr V M Katoch, however, says that he is not aware about the formation of any special committee on the issue. Speaking to BioSpectrum, he adds, “I am not aware about the formation of any specific committee for probing the NDM-1 superbug. The talks about the antibiotic policy are because of unchecked use of antibiotics and the focus here is not only NDM-1 but the overall microbial resistance issue. At ICMR, we are clear that  it does not have any huge social implications and that this is just a hype created to tarnish the image of the country,” says Dr Katoch. There seems to be an overall consensus among the experts about the universal presence of superbugs. The experts say that it is present in the soil, water and even in the gut. The important questions being raised are, if the rise of this superbug is linked to the use of antibiotics called carbapenems, then how can it be possible that the infection is water borne and how can the people of India tackle this kind of antibiotic issue? Expressing surprise over the fears being created in the minds of the people, Dr Katoch, said that the superbug exists everywhere in the world and it is unfair to call India as the hotbed of superbugs. Dr V S Chauhan, director, International Centre for Genetic Engineering & Biotechnology (ICGEB), New Delhi, chose to slightly differ on the issue. He said, “We need to take this seriously and carefully investigate its implications on public health. It is very important to ensure that it doesn't get into the drinking water system.” Meanwhile, the press release by the Health Ministry also pointed out to the study carried out by Sir Ganga Ram Hospital, New Delhi, in the affected area. It shows that E. coli, which is  isolated from the gut of a large randomly selected sample of a pregnant women did not show any carbapenem resistant E. coli in the stool samples, thus indicating no presence of NDM-1. Most of the members of the scientific community agree that the research findings have gone too far in blaming Indian hospitals and prevalent hygienic conditions. One expert went to the extent of calling it an attack on the medical tourism in India. Rahul Koul in New Delhi ]]> <![CDATA[Gates Foundation ramps up vaccine initiatives]]> https://biospectrumindia.com/news/95/2997/gates-foundation-ramps-up-vaccine-initiatives.html https://biospectrumindia.com/news/95/2997/gates-foundation-ramps-up-vaccine-initiatives.html Mon, 09 May 2011 11:35:00 +0530 India is on the radar for the US-based  philanthropic organization and will certainly benefit from the rolling out of mammoth funding initiatives in vaccine development and delivery Speaking at the World Economic Forum at Davos last year, Microsoft founder and philanthropist, Bill Gates, called  upon  the global community and  announced that in the coming decade,  the Bill and Melinda Gates Foundation would donate a whooping sum of  $10 billion towards the development and delivery of vaccines to the developing nations of the world. Defining 2011 to 2020, as the decade for vaccines and polio immunization, Mr Gates further added that through these grants, he is looking at creating a drastic drop in child mortality due to diseases like malaria, tuberculosis, pneumonia and diarrhea for which vaccines are yet to be made available. He further said that vaccines for these diseases would save around eight million children by the end of 2020. Mission India Amongst developing nations, India stands as a priority region for the foundation. As of December 2010, the foundation committed approximately $1 billion for health projects in India. The Gates Foundation works on a range of health and development efforts in India, including immunization, maternal and child health, family planning, HIV/AIDS, TB, water and sanitation efforts and agricultural development.  Speaking to BioSpectrum about the foundation's funding initiatives in the country, Mr Ashok Alexander, India Country Office, Bill & Melinda Gates Foundation, says, “Though statistics in India reveal that in 2008, approximately 54 percent of children in India received  full set of vaccines as recommended in India's national immunization programme, a lot needs to be done. Grants include support to polio eradication efforts through the Global Polio Eradication Initiative (GPEI), the introduction of hepatitis B vaccine through the GAVI Alliance and late-stage clinical development of a new rotavirus vaccine to reduce severe diarrhea in young children.” The Gates Foundation also supported the development of the bivalent oral polio vaccine, which was introduced last year in India and has helped reduce cases of polio virus types 1 and 3 to record lows. “India has made remarkable progress against polio, however, outbreaks still persist. Until eradication is achieved, the various program activities have to be continued to end this disease,” adds Mr Alexander. Diseases like pneumonia and diarrhea have off-late been of growing interest to the foundation. Today, in India, pneumonia and diarroheal diseases like rotavirus, currently, account for approximately one-third of all deaths among Indian children younger than five years of age. “As the world's leader in vaccine manufacturing, India has an unparalleled ability to develop new, safe and effective vaccines and make them available to Indian children at affordable prices. Through our grantee PATH Vaccine Solutions, the Gates Foundation is working with the Serum Institute of India and Bharat Biotech to support the development of innovative, high-quality, low cost vaccines for rotavirus, which causes severe diarrhea, and pneumococcal disease,” says  Mr Alexander. Partnerships Since its inception, the foundation has been partnering with national and state governments, scientists, manufacturers, NGO and community leaders in exploring ideas on delivering vaccines and other interventions that benefit Indians and others worldwide. “One of our strongest partnerships in India is with the government of Bihar. Along with the state governments and leading domestic and international NGOs, we recently launched a five-year, $80 million portfolio of grants to address maternal and child health issues,” adds Mr Alexander. Bill and Melinda Gates visited India in March 2011 and met policy makers, non-government partners, business and community leaders, and public health figures (celebrities) urging stakeholders to intensify progress on vaccinating its populace, especially children. During their visit, Bill and Melinda Gates announced that they would pool in grants to fund late stage clinical trials to Pune-based Serum Institute of India and Hyderabad-based, Bharat Biotech International, for pneumonia and  rotavirus vaccines. Though the parties were reluctant to reveal the exact value of the grants, reports have highlighted that the  foundation is looking at granting around $30 million for late stage clinical trials of rotavirus vaccines. Looking Forward Giving an overall perspective, the Gates Foundation believes that in the avenue of vaccines, India still faces some critical challenges like scaling up routine immunization and access to newer vaccines, such as for measles and certain types of diarrhea and pneumonia. Partnerships with local stakeholders will be a springboard to tackle this challenge. “The foundation will continue to work with the Indian government and all of our local partners to find solutions to scaling up routine immunization and access to vaccines. This includes support for research that reinforces the lifesaving value and cost-effectiveness of these vaccines; continued work with Indian researchers and companies to produce new, safe and less expensive vaccines and partnerships with governmental and non-governmental groups,” concludes Mr Alexander. Nayantara Som in Mumbai ]]> <![CDATA[Life sciences firms chant IPO mantra]]> https://biospectrumindia.com/news/95/2749/life-sciences-firms-chant-ipo-mantra.html https://biospectrumindia.com/news/95/2749/life-sciences-firms-chant-ipo-mantra.html Mon, 09 May 2011 11:28:00 +0530 The life sciences sector is gradually undergoing a metamorphosis. From being a risk-averse segment in the past, to looking towards the public market — in order to meet large scale growth and expansion plans With the Indian markets picking up in the year 2010, floating an Initial Public Offering (IPO) is  becoming the favored route for mid-sized life sciences companies to meet large-scale expansion plans. Last month, the industry saw three prominent companies, namely Intas Pharma, Arch Pharmalabs and Calyx Chemicals filing for the Red Herring Prospectus (DRHP) with the Securities and Exchange Board of India (SEBI), all within a span of seven days. The shift of the bullish market sentiments, from all-time favourite sectors like real estate and IT towards niche sectors such as life sciences, are said to be some of the reasons for this development. Is this the right time for IPO? Market analysts and investors are hopeful that the coming months will witness several IPOs from this sector. Says Sanjay Singh, associate director, Corporate Finance, KPMG, “Several mid size pharmaceutical companies are expanding their operations in R&D, manufacturing and marketing functions and require capital. In some cases, capital is needed to rationalize the debt/equity ratio. We will continue to witness IPOs of growth oriented pharmaceutical companies that have achieved the critical mass and scale in their operations.” With the markets now reaching an all time high, analysts opine that this is the right time for companies to go in for an IPO. “The market timing of several DRHP filings is just right as the BSE Sensex is inching back towards the 20,000 mark. This would indicate that the recent DRHP filings are not due to ‘spillover effect' but just preempting market timing to gain better premiums for the investors who are diluting their shareholding through the IPO route,” elaborates Kapil Khandelwal, director, Makven Capital, a niche investment banking and advisory services company. Dr Nitin Deshmukh, CEO, Private Equity, Kotak Private Equity Group (KPEG), Mumbai, who has been a prominent figure in the industry spearheading funding for most of the top life sciences companies including Biocon, also provides an insight. He says, “We do have some quality IPOs in the pipeline. Earlier most companies were apprehensive of going public because of the volatility in the market. But now markets look strong and the pharmaceuticals' sector has demonstrated good earnings growth which makes it a stable sector to invest.” In addition to this, recent turn of events in the last  year could prove to be brownie points for life sciences companies. “Increasing foreign interest in the sector along with a slew of mergers, acquisitions and high valuations of companies over the past one year has changed market sentiments towards this sector.” says Sujay Shetty, director — Pharma and Life Sciences,  PricewaterhouseCoopers. The only dampener could be the talks regarding the Indian government putting a cap on FDI and introducing price control measures on drugs. While in the past, companies in the contract research and manufacturing services (CRAMS) space were the favourites amongst investors, it is no longer the case in the present scenario. “Companies having a good size revenue before going public and companies with a strong domestic presence have the upper hand. Also, companies into Biogenerics are gradually turning out to be favourites amongst investors,” adds Dr Deshmukh. Last year, Gujarat-based injectables' company, Claris Life Sciences, floated an IPO but received a lukewarm response from the market. According to an industry observer, from a PE firm, “The market at that time went into a bearish outlook and it was not the right time to go in for an IPO. Coupled with this, was the recall of one of the company's products from the US market.” Companies that filed IPO in the past one year Segment IPO Issue Price Multiple PE Dilution Over/Under Subscribed Intas Pharma Pharma Apr 2011 DRHP Filed NA Yes NA Arch Pharmalabs Pharma Apr 2011 DRHP Filed NA Yes NA Super Religare Labs Mar 2011 DRHP Filed NA No NA Omkar Speciality Chemicals Specialty pharma intermediates Jan 2011 98 9.8 No 4.67 times Claris Lifesciences Injectables Dec 2010 228 22.8 No 1.50 times Marck Biosciences Pharma Oct 2010 DRHP Filed NA Yes NA Parabolic Drugs API June 2010 75 7.5 Yes 1.20 times Syncom Healthcare Formulations Jan 2010 75 7.5 No 5.17 times Expansion plans for companies By floating an IPO, Intas Pharma, Arch Pharmalabs and  Calyx Chemicals are looking to raise 425 crore, 135 crore and 100 crore of capital funds respectively. Intas Pharma has identified biosimilars as a long term growth opportunity and is expected to continue to make substantial investments in manufacturing, in-house development and marketing of products based on biotechnology, with a focus on high-growth therapy areas such as oncology, nephrology and arthritis. The company  is looking at streamlining a chunk of the net proceeds from the IPO into its biopharmaceutical subsidiary, Intas Biopharmaceutical (IBPL). The subsidiary, which was acquired by the parent company (Intas Pharma) in December 2010, has investments worth 322.4 crore, including in-house development and manufacturing of products based on recombinant DNA. It has currently developed and fully commercialized five products in India and other semi-regulated markets in Africa, Latin America and Asia Pacific. It has additional 11 projects at advanced stages of development, nine of which are for the Indian market and two for the regulated markets. At the Moraiya facility, Ahmedabad, which is operated by IBPL, the company intends to invest over 15 crore from the net proceeds towards acquisition of ready premises and expansion of the given facility in three stages. Arch Pharmalabs, which apart from APIs and intermediates also looks at CRAMS, is looking at repayment or prepayment of term loan, capital expenditure towards existing manufacturing facility, investment in EHS infrastructure and corporate R&D center. Calyx Chemicals has major plans to  expand its CRAMS business, globally, and it has revealed that around 80 percent of its proceeds are being fed in doubling its existing manufacturing capacity at Tarapur.   Bangalore based-biotech company, Avesthagen, is also looking at going the IPO route to raise around 700 crore for its expansion plans. The  company began the exercise back in 2008, but had to shelve its IPO plans due to the economic downturn. In 2010, Avesthagen CMD Villoo Morawala-Patell  announced that the company would launch its IPO offerings towards the second half of 2010. The plan has already run into delays. Looking into the future, if Avesthagen's IPO comes through, we could expect to see expansion of the manufacturing and marketing capabilities of its products, mainly biosimilars. Market analysts also reveal that Emcure Pharmaceuticals is planning to raise around 600-700 crore through the IPO route.   Top PE exit for rich gains   Going public is good news not just for companies but also for private equity (PE) players who are looking at monetary profits by exiting from these companies. Though the exact returns are not yet available, the multiples could go beyond the five times mark, claim market analysts. Says Khandelwal, “With the Sensex looking bullish and touching levels which were last seen during 2007, we can expect PE exits with higher returns and gains.” ChrysCapital is selling half of its holding in Intas Pharmaceuticals (5.61 percent stake) out of its total holding of 11.2 percent. Five years back, the firm had picked up a stake from ICICI ventures and had invested 48 crore in the Intas. Arch Pharmalabs will see the exit of six of its PE shareholders. ICICI Venture is part-exiting its investment in Arch Pharmalabs through India Advantage Fund V, which holds 21.1 percent stake and fully exiting through India Advantage Fund II (1.45 percent), Dynamic India Fund I (1.77 percent) and Rainbow Fund (0.02 percent). Swisstech VCF is also exiting by selling its entire 8.16 percent stake, while Leverage India Fund is selling around one-third of its 7.28 percent stake. In conclusion, it can be stated that the move to float an IPO is considered as a welcome sign by both the investors and the market observers. “It has been a long time since we have seen a good IPO in this sector. Looking at the profiles of some of the companies filing in DRHP, some positive outcomes are in the offing,” says Dr Deshmukh. Nayantara Som in Mumbai ]]> <![CDATA[INB gets recognition for DNA forensics]]> https://biospectrumindia.com/news/95/2808/inb-gets-recognition-for-dna-forensics.html https://biospectrumindia.com/news/95/2808/inb-gets-recognition-for-dna-forensics.html Tue, 12 Apr 2011 17:27:00 +0530 Indian Biosciences (INB) has successfully completed the DNA identification of charred remains of victims of a cargo transport airplane that crashed in the mountains to the east of Afghanistan’s capital Kabul, in 2010. The DNA identification profiles for all the samples were prepared and matched as per FBI Laboratory’s Combined DNA Index System (CODIS) international standards. Dr KS Mehta, director, Indian Biosciences, said, “The DNA identification and matching was carried out successfully and the families of the victims have received their rightful remains.” Max Neeman assigns experts for trials Max Neeman International, a clinical research services company in India, has established a team of experts specialized in carrying out rare disease trials in response to sponsor demand. Max Neeman has been focusing on rare disease trials, in addition to other indications. Patient enrollment for rare disease, complex global and multi-centric trials is challenging because potential subjects are fewer in number and widely dispersed. India has evolved into a preferred destination for conducting such trials because of low-cost and faster patient recruitment supported by the country’s diverse gene pool and vast population. Intas Pharma files for IPO Intas Pharmaceuticals has filed its draft red herring prospectus with Securities and Exchange Board of India (SEBI) for an initial public offering of its equity shares of face value $ 0.22 (10) each comprising a fresh issue of Equity Shares aggregating up to $95.5 million (425 crores) and an Offer for Sale of 5,810,550 Equity Shares by Mozart Limited. The Issue, will be made through a 100 percent book building process wherein not more than 50 percent of the issue shall be allocated on a proportionate basis to qualified institutional buyers, not less than 15 percent of the Issue shall be allocated to non-institutional bidders and not less than 35 percent of the issue shall be available to retail individual bidders. Ecron acquires stake in aCROnordic Ecron Acunova (EA), a full-service CRO, announced the acquisition of majority stake of aCROnordic, a CRO specialized in clinical research in Denmark, Sweden, Finland and Norway, with its headquarters in Denmark. Mr Soren Stroh, founder of aCROnordic, continues his role as CEO for Nordic region. Mr DA Prasanna, founder and chairman of Ecron Acunova, said, “A recent change in the strategy of sponsors in the healthcare industry asks for more global presence of preferred provider CROs. The merger of EA and aCROnordic will yield substantial synergy to both of us for serving our clients’ needs.” THR-100 enters phase III trials Bharat Biotech, a multidimensional biotechnology company in India, has initiated a phase III clinical trial in India with Clot-Busting Drug THR-100 (Staphylokinase), a thrombolytic agent for the treatment of myocardial infarction. The company is going in for trial in India with THR-100 in patients suffering an acute myocardial infarction (AMI or heart attack). The trial is expected to recruit approximately 120 patients. Earlier, Bharat Biotech had entered into a license agreement with ThromboGenics for the manufacture, clinical development and commercialization of THR-100 with the objective of potentially commercializing it as a replacement for established thrombolytics, such as streptokinase and urokinase, in developing markets in December 2006. The novel variant of recombinant staphylokinase, THR-100 is developed for the treatment of AMI and other vascular diseases, based on its ability to dissolve blood clots. According to the company sources, the phase III trial with THR-100 is anticipated to be completed in the second half of 2011. The results of this phase III trial will later pave the way for this thrombolytic to be filed for marketing approval by Bharat Biotech with Indian regulatory authorities. Panacea Biotec signs new deal Panacea Biotec has signed a non-exclusive marketing agreement with Laboratorios Clausen of  Uruguay. The agreement will give an access to Laboratorios Clausen to market Panacea Biotec’s Tacrolimus (Pangraf) in few markets in Europe. The agreement was signed in presence of His Excellency Mr Danilo Astori, vice president of the Oriental Republic of Uruguay, who was in India on an official visit to sign economic pact. In a separate agreement of technology exchange, Panacea Biotec agreed to explore the possibility of technology transfer of its product to Laboratorios Clausen manufacturing facility and for subsequent marketing in Latin American markets. Aurobindo gets FDA approval Aurobindo Pharma announced that the company has received final approval from the US FDA to manufacture and market Fosinopril Sodium tablets USP 10mg, 20mg and 40mg. The product falls under the cardiovascular (CVS) therapeutic category. The product has a market size of approximately $20 million for the 12 months ending September 2010 according to IMS and will be launched shortly. Aurobindo now has a total of 134 ANDA approvals (102 Final approvals and 32 Tentative approvals) from USFDA Fortis signs pact with TotipotentRX Fortis Healthcare (India), a fast growing hospital network and TotipotentRX Cell Therapy, a US-based provider of cutting-edge technologies in the stem cell and regenerative medicine market, announced a collaboration to set up centers of excellence offering cellular therapies and stem cell clinical trials, across select Fortis hospitals. These centers will undertake stem cell clinical research procedures relating to diabetes, cancer, cardiovascular disease, and neurological ischemia. TotipotentRX will also set up state-of-the-art cGMP laboratories in select hospitals, for processing stem cells before transplantation to patients. Full genetic report for 20,000 Pune-based Acton Biotech recently launched its full genome scan which will primarily look at giving a detailed genetic report of a person. This full genome scan costs $447 (20,000) and it takes one month to prepare the report. This will contain information about a person’s genes, the diseases he might have in his life span and a list of drugs that will be in-efficacious or may cause severe side-effects. In addition to this, regular updates will be sent to the person as and when research laboratories find something new in his genes. The procedure involves collection of a person’s blood sample at collection center across cities which is subsequently sent to Acton’s facility in Pune, where extraction and quality control checks of the sample will be done. Agilent sets up its largest R&D lab in Bangalore Agilent Technologies has expanded its life sciences and chemical analysis center of excellence in Bangalore. The company also opened a life sciences application development lab to accelerate the discovery of life sciences analysis workflows. Together, the center and lab cover 8,000 sq.ft., making this the largest Agilent research facility in the world. Agilent application scientists engaged in pharma, biopharma and other life science applications, staff the facility and work hand-in-hand with customers, thereby having access to critical samples and learning about emerging application needs. The Bangalore Center of Excellence is modeled on the same standards as other Agilent centers, with an emphasis on Agilent's global environmental, health and safety guidelines. ILS joins hands with Affymetrix for microarray solutions Imperial Life Sciences (ILS), has tied up with Affymetrix, a US-based microarray technology provider. From small personalized microarray platform (GeneAtlas) and versatile microarray instrumentation (GeneChip 3000 7G) to fully-automated microarray instrument (GeneTitan), Affymetrix has products for automated solutions to scientists. With this agreement, ILS is looking forward to take the wide range of microarray platforms and arrays for multiple applications like gene expression studies, SNP genotyping, resequencing analysis, CHIP-on-chip studies to its clients. Affymetrix has more than 425 patents and 1,800 systems installed worldwide. ILS hopes that the collaboration will help the company provide world-class service and support to its customers. ]]> <![CDATA[EmTech India 2011 speakers give insights into vaccine R&D]]> https://biospectrumindia.com/news/95/6537/emtech-india-2011-speakers-give-insights-into-vaccine-rd.html https://biospectrumindia.com/news/95/6537/emtech-india-2011-speakers-give-insights-into-vaccine-rd.html Tue, 12 Apr 2011 17:26:00 +0530 Speakers at EmTech India 2011 spoke about the innovations that are being undertaken by their organizations and how these could be applied to business and strategy. (L-R): Dr Sanjay Kakkar, trustee, Thrombosis Research Institute, Bangalore; Dr Chetan Chitnis, principal leader – Malaria Group, ICGEB, New Delhi; Prof D Balasubramanian, director of research, LV Prasad Eye Institute, Hyderabad; Mr Udaykumar Ranga, professor, JNCASR, Bangalore; and  Mr Jeffrey M Karp, assistant professor in Medicine at Harvard Medical School, US, took part in a panel discussion on ‘Activating the Innovation Gene’ held as part of EmTech 2011 in Bangalore, India, on March 22, 2011. The EmTech India 2011 conference in its third edition in India saw several eminent personalities shed light on the emerging trends and the future of technology. The event, which is conducted every year by MIT's Technology Review’s India   edition by CyberMedia, Asia’s leading technology publisher, was held during 22-23 March in Bangalore. The plenary session on day one of the event saw several speakers discuss the imperatives in the field of vaccine research. The speakers included Dr Chetan Chitnis, principal leader, Malaria Group, International Center for Genetic Engineering and Biotechnology (ICGEB), Delhi; Professor Udaykumar Ranga, Professor, JNCASR, Bangalore; Dr Sanjay Kakkar, Trustee, Thrombosis Research Institute, Bangalore and Dr Jeffrey M. Karp, HST Affiliate Faculty, Assistant Professor in Medicine at Harvard Medical School and Co-Director, Regenerative Therapeutics Center, Brigham & Women’s Hospital. The session was moderated by Dr D Balasubramanian, director of research, LV Prasad Eye Institute, Hyderabad. Dr Chitnis, while sharing his thoughts on the kind of innovation happening on developing vaccine against malaria, said, “We are developing a vaccine for P. vivax malaria based on PvRII. Methods to produce recombinant PvRII have been developed and efforts to identify an optimal adjuvant formulation are underway. Clinical grade P. falciparum vaccine candidate JAIVAC-1 has been manufactured under cGMP by an Indian biotechnology company, Bharat Biotech, Hyderabad.” Government of India's Million Death Study revealed that about 205,000 Indians under age 70 die annually due to Malaria. On the other hand, World Health Organization (WHO) reports put the figure at 15,000.  Also, the Indian population is at high risk of heart attacks when compared with the population in the West because of many factors including, life style changes and smoking among others. Considering the increase in the number of people that are being diagnosed with cardiovascular diseases, Bangalore based Thrombosis Research Institute, has developed a DNA based saliva test to check the risk of heart disease. Speaking at the panel discussion, Dr Kakkar said, 'The genetic test has been designed specifically for the indigenous population, using the Western technology. After verification and known risks, preventive measures for weight, adequate exercise and proper diet to reduce the risk of such losses can be started.” Professor Ranga, while speaking on developments made by the team at the Molecular Biology and Genetics Unit, on developing HIV vaccine said, “India can look at utilizing the expertise gained in traditional medicine such as ayurveda, unani, siddha medicines over thousands of years, in developing poly herbal medicine for HIV. ” Meanwhile, Dr Karp, pointed out that commercialization will always drive innovation. ]]> <![CDATA[BioSpectrum Asia Pacific Life Sciences Forum & BioSpectrum Asia]]> https://biospectrumindia.com/news/95/4877/biospectrum-asia-pacific-life-sciences-forum-biospectrum-asia.html https://biospectrumindia.com/news/95/4877/biospectrum-asia-pacific-life-sciences-forum-biospectrum-asia.html Tue, 12 Apr 2011 17:24:00 +0530 Singapore, March 16, 2011 Special Report BioSpectrum organized the Asia Pacific Life Sciences Forum with the objective of providing a thought-sharing platform for the life sciences companies across the region Asia on the growth curve Mr Narayanan Suresh, chief editor, BioSpectrum Anchoring the Forum, Mr Narayanan Suresh, chief editor, BioSpectrum, kick-started the discussion by quoting Steven Burrill, CEO, Burrill & Company, and said, â€œPartnerships will continue to grow, particularly with companies in biopharma space. This trend will continue and most of the collaboration will take place in Asia and Latin America. The deals will continue to happen but there will be a change in the way that partnerships are going to happen.â€? Dr Yusuf K Hamied, CMD, Cipla, India Giving a deeper insight into the South East Asian market, Dr Yusuf K Hamied, CMD, Cipla, India, said, â€œOne must realize that intellectual property plays an important role in the pharmaceutical industry and it is a main issue in India and China. In the last 50 years, not one single new chemical entity has emanated from the South and hence the â€œbalance of IPâ€? is very important. If Asia has to emerge at the global level, it can be either done by joining hands with multinational companies, as many are doing or the government of Asian countries should bring in a compulsory licensing system and we pay royalty to the originators and make generic version of important drugs for our country.â€? Strategic alliances The first panel discussion was centered on 'strategic alliance' and comprised panelists including Mr Carl Firth, CEO and founder, Aslan Pharmaceuticals, Singapore, Mr Dan Devine, CEO, Patrys, Australia and Dr Yap Kok Wei, CEO, Gleneagles CRC. Sharing his thoughts on the aspects that lead to the necessity of a partnership, Dr Yap Kok Wei mentioned that additional funding for marketing and distribution of a product is often an open space for merging. â€œWhen a growing company merges with a big company, it gets support to stand and survive in the industry and develop its projects in the pipeline,â€? he opined. Mr Carl Firth believes that alliances catch the attention of the industry, and said, â€œToday the exciting deals are taking place in the field of R&D that can accelerate drug development capabilities of Asia. Partnerships like Bristol-Myers Squibb with Simcere, a Chinese biotech company, lead to faster drug development.â€? Mr Dan Devine said, â€œEach one of our molecules for cancer is different and when we go for a partnership, we convince our investors about the worth of investing. It is difficult to navigate the landscape when there are multiple drugs in the pipeline in oncology and to convince the investor about the benefit of your own product amid the stiff competition. We tend to be accelerating to clinical trial quicker, and that is why partnerships become extremely important in oncology. The main concern is to raise capital and we are always balancing the act. So we have to be sensible when the partnership goes hand in hand. Before partnering, the partners should be honest to each other instead of spending much time on negotiations.â€? Dr Yap Kok Wei, CEO, Gleneagles CRC Mr Carl Firth, CEO, Aslan Pharmaceuticals, Singapore (left) and Mr Dan Devine, CEO, Patrys, Australia (right) Sustainable business models Taking the discussion ahead, Mr David Picard, CEO, Moleac, Singapore, Dr Muhammad Tani Bin Tabiin, senior vice president, Biomedical Sciences Division, Exploit Technologies, Singapore and Dr Lex Lee, VP, Medical Affairs, Pharmigene, Taiwan shared their perspective on 'sustainable business model'. Dr Tani said that A*STAR is working to promote small and big biotech companies in Singapore through a well co-ordinated effort between different technology and financial agencies in the country. Mr Picard, giving example of Moleac, opined that successful business can be executed by innovative products and technologies. He said, â€œMoleac plays an innovative role in identifying products from traditional Chinese medicine to address the gaps in the West.â€? Dr Lee, from Pharmigene, emphasized on the philosophy that good ideas are generated from all corners of the world. He said, â€œAsia offers a complete portfolio of innovation and there is a need for infrastructure to develop good ideas into great investments.â€? Mr Narayanan Suresh, chief editor, BioSpectrum (left) and Mr David Picard, CEO, Moleac, Singapore (right) Dr Muhammad Tani Bin Tabiin, Sr. VP, Biomedical Sciences Division, Exploit Technologies, Singapore (left) and Dr Lex Lee, VP, Medical Affairs, Pharmigene, Taiwan (right) Awards Nite Rocks &lt&lt &gt&gt ]]> <![CDATA[Compulsory barcoding decision halted]]> https://biospectrumindia.com/news/95/2023/compulsory-barcoding-decision-halted.html https://biospectrumindia.com/news/95/2023/compulsory-barcoding-decision-halted.html Tue, 12 Apr 2011 16:59:00 +0530 Recently, the Union Health Ministry decided not to take a hasty decision to enforce compulsory barcoding on all medicine strips, as the case is pending in the Allahabad High Court. BioSpectrum explores what the furore is about? In May 2009, the Ministry of Commerce, Government of India was in for a rude shock, when they received a statement from Nigeria’s NAFDAC, which stated that around $2.16 million worth of anti-malarial drugs bearing ‘Made in India’ labels were seized by the Nigerian authorities. The labels indicated  that the drugs were manufactured in India, but the bill of loading revealed that they had been exported from China. In addition to this, there were reports doing the rounds in the African markets alleging all Indian generic drugs to be spurious or counterfeit drugs. The Indian Directorate General of Foreign Trade (DGFT) in its battle against counterfeit drugs, issued a notification on January 2011, making it mandatory for all pharmaceutical and even biological (like vaccines) companies to affix barcodes on their export products to track and trace their stock  across the entire supply chain. According to the mandate, the DGFT clearly states that products need to build track and trace capability for their exported medicines using barcode technology as per GS1 global standards. Such barcoding is required at primary, secondary and tertiary level packaging. This includes incorporating (at all the three levels)  2D and 1D (GS1 data Matrix) medicines at strip/vial/bottle level encoding unique product identification code (GTIN), batch number, expiry date and serial number. The deadline  given to all pharma exporters to put barcoding systems in place is July 2011. Figures and facts on the share of counterfeit products vary but the unanimous conclusion remains that India is moving towards being the hub for spurious medicines. A survey of 10,000 samples, funded by the World Health Organization (WHO) and undertaken by the International Pharmaceutical Federation last year concluded that 3.1 percent of all drugs in India were counterfeit. Another survey stated that around 10-20 percent of drugs in India were counterfeit medicines. A follow-up survey, conducted by the Central Drugs Standard Control Organization (CDSCO), found the prevalence of spurious drugs at 0.046 percent of all medicines sold to customers. Opposition to the mandate Giving a bird’s-eye view of the government’s expectations from the industry, Dr Praful Naik, CSO, Bilcare Research, says, “The mandate is a wake up call for all Indian companies and ideally this should have been an industry initiative. Post the seizure in Nigeria, the Indian government does not want to take the  blame for export of any spurious drugs to other countries. Before announcing the mandate, DGFT had  taken consensus of industry bodies. I see this mandate from a positive angle.” The notification at large, has given rise to fierce opposition from the industry on the grounds that it could lead to delays and drastically hamper drug exports from the country. Baring the top Indian and MNC companies, who have already incorporated the practice into their systems, many medium and small-sized companies would view such an exercise as cumbersome and expensive. The cost of affixing barcodes (per pack) comes up to approximately one-and-a-half dollars, says an industry expert. The deadline of July 2011 is too short a notice. A section of the industry is also of the opinion that the mandate is a bit obscure and needs to be more clear in its specifications. For example, though the mandate is applicable to biotech products, many companies claim that it is still not clear to them as to which class of biotech products the mandate is applicable to.  The Indian Drug Manufacturers Association (IDMA) submitted a letter to the DGFT, stating that in a country like India where exports are equivalent to $10 billion and there are more than 3,500 exporters, implementing this system would not be practical. The association said that machinery for such type of barcoding is not available in India and exporters in the small scale sector cannot afford to implement it. The letter states that, “By introducing the above, we as a country are giving a wrong impression to the importing countries that we are producing counterfeit drugs and therefore the Government of India has put this type of restriction.” According to IDMA, the government should have a face-to-face ‘open meeting’ with industry players to understand feasibility of implementing such a system. Reports from the IDMA suggest that the DGFT is yet to respond to such a request. Nayantara Som  in Mumbai ]]> <![CDATA[NPPA boosts insulin players]]> https://biospectrumindia.com/news/95/2245/nppa-boosts-insulin-players.html https://biospectrumindia.com/news/95/2245/nppa-boosts-insulin-players.html Tue, 12 Apr 2011 16:58:00 +0530 The National Pharmaceutical Pricing Authority (NPPA) has increased prices of 62 drugs, including human insulin, giving a boost to local manufacturers. The NPPA has increased the price of locally-manufactured human insulin by up to 18.55 percent after considering the rising conversion cost, packing charges, process loss and packing material. Mr Sameer Savkur, managing director of IMS Health Information and Consulting Services India, says, “Price revisions are on account of the increase in product input costs. These are reviewed by NPPA on an ongoing basis, and revised as thought necessary for all molecules and formulations under price control.” The price increase will help the local insulin manufacturers – namely Biocon and Wockhardt who account for nearly 10 percent of the total insulin market of 612 crore. Multinational firms have over 75 percent of the marketshare, including Novo Nordisk and Eli Lilly, which have 53 percent and 22 percent respectively. To overcome competition in the local market, indigenous insulin manufacturers have entered into global alliance with several US companies. In February, this year, Wockhardt entered into a strategic global alliance with US-based Sheffield Bio-Science, under which the latter will have exclusive sales and distribution rights to supply recombinant insulin to the cell culture markets. In October, last year, Biocon signed a mega marketing deal with Pfizer to globally commercialize biosimilar versions of Insulin and Insulin analog products: Recombinant Human Insulin, Glargine, Aspart and Lispro. According to the deal, Pfizer will make upfront payments worth $200 million. Biocon is also eligible to receive additional development and regulatory milestone payments of up to $150 million and will receive additional payments linked to Pfizer’s sales of its four Insulin biosimilar products across the global markets. The price increase from NPPA and the global alliance with US companies will definitely boost insulin sales and earn revenue for the companies in the near future. Narayan Kulkarni, Bangalore ]]> <![CDATA[Biotech SEZ hit by MAT]]> https://biospectrumindia.com/news/95/1704/biotech-sez-hit-by-mat.html https://biospectrumindia.com/news/95/1704/biotech-sez-hit-by-mat.html Tue, 12 Apr 2011 16:57:00 +0530 The Union Budget proposal to bring SEZs under the purview of the Minimum Alternate Tax is bound to slow down the growth and impact future investments into these zones. The Finance Minister of India, Mr Pranab Mukherjee, has been criticized for introducing five percent service tax on services provided by hospitals and diagnostic centers in his budget proposal for 2011-12. He also proposed to levy the Minimum Alternate Tax (MAT) of 18.5 percent on profits for both SEZ developers and units. This would be effective from April 2012, the Direct Tax Code (DTC) will also get implemented in the same year. The Finance Minister justified that such a step was needed “As a measure to ensure equal sharing of the corporate tax liability.” Real estate developers and biotech companies that have made large scale investments in SEZs, have condemned the Finance Minister’s proposal stating that such a move would lead to either developers/ units opting out or putting their projects on hold, hamper inflow of capital funds and investments and stifle exports from these zones. Uncertainties The biotech SEZ community and the industry at large had no expectations from the Union Budget this year, but neither did they imagine that the Finance Minister would bring to the table, steps regressive to their venture plans. An authority from Biocon says, “We were not expecting any change in policy and expected the government to continue the original commitments on the tax holiday as per the SEZ policy.” A MAT of 18.5 percent is an exorbitant rate and may force developers and units to rethink their plans and take drastic steps. Developers as well as units will find it difficult to attract investments from private equity and other investors as SEZs would become less attractive. Biotechnology is a capital intensive industry where the gestation period for returns is approximately 10 years. Incentives in the form of tax holidays and exemptions from the government is but an impetus to bolster growth and production. Scope for revival Having faced vehement opposition since February 2011, there have been talks doing the rounds of the Finance Minister considering reviewing the proposal following demands by SEZ developers and units. Rahul Khullar, Commerce Secretary said that there is a possibility to reverse the decision on MAT as the implication of MAT would hurt the sentiments of SEZ developers as well as SEZ Units. A review of the proposal by the government of India will certainly help the Indian biotech industry significantly. Industry experts are of the opinion that there is a slim chance that the government, which draws five percent service tax on health services, would reconsider the plight of India’s SEZs. Industry response The Union Budget has been disappointing for the corporate sector. Not only has the finance minister has increased MAT for the corporate sector, but he also brought SEZs under the MAT ambit. However, today SEZs are lost in the maze of ad-hoc policy and questionable practices. — Dr Kiran Majumdar-Shaw, CMD, Biocon I was expecting the government to at least increase the time period of the tax exemptions. But the introduction of MAT or any other tax defeats the whole purpose of setting up SEZ. It is almost like the government is going back on its word. — Dr SD Ravetkar, senior director, Serum Institute of India, Pune Introduction of MAT on SEZs seems to be a retrograde step. From a zero base of no tax, this is going to be a huge burden. From a “No-Tax” regime for certain period, now the Developers and Units will have to pay MAT which would affect their cash-flow and capability for further investment and expansion of projects. — Mr Prasanta Biswal, CEO, International Biotech Park, Pune It just shows the credibility of the government. The service industry within these SEZs will be badly hit. Units have committed a lot of capital towards their investments in Biotech SEZs. There are a lot of stakeholders involved here and a sudden change in the rules can make calculations go awry. Developers will walk away from projects. — Dr Dilip G Tripathi, MD, Tulip Diagnostics, Goa MAT will be discouraging for both domestic and foreign companies from venturing into our SEZ. We have just started developing our project which we will complete by December 2011. The tax implementation will discourage tenants to take up space in our GLP labs as well as for units to put up their R&D/ manufacturing on our SEZ. — Ms Minakshi Sharma, AVP — marketing, Mayar Biotech, Gurgaon. I was expecting the government to at least increase the time period of the tax exemptions. But the introduction of MAT or any other tax defeats the whole purpose of setting up SEZ. It is almost like the government is going back on its word — Dr SD Ravetkar, senior director, Serum Institute of India, Pune Nayantara Som in Mumbai ]]> <![CDATA[Bt Maize trials shown red signal]]> https://biospectrumindia.com/news/95/1120/bt-maize-trials-shown-red-signal.html https://biospectrumindia.com/news/95/1120/bt-maize-trials-shown-red-signal.html Tue, 12 Apr 2011 16:55:00 +0530 The stopping of of Bt Maize trials in Bihar by the Environment Ministry has raised several grave questions. The absence of a clear policy regarding the commercial utilization of the outcome of huge investments into R&D of various crops, is seen as a major hindrance to the agri-biotech sector Bt crops has once again found itself admist controversies in India. Mr Jairam Ramesh, the minister for forest & environment, had during March, directed the Genetic Engineering Appraisal Committee (GEAC) to immediately cancel field trials for Bt maize in Bihar. Maize is India’s 3rd largest cereal crop. Mr Ramesh intervened after Bihar chief minister Nitesh Kumar put his strong objections on the trials before the Environment Ministry. In a letter written to the GEAC, Mr Ramesh also instructed the GEAC to give state governments a month's time to agree or disagree with the field trials of GM food crops. The ministry's decision to overlook the GEAC has also raised questions on the powers of the regulatory body.  Earlier the GEAC, which is under the ministry of environment and forests, had allowed US-based  biotech  giant, Monsanto, to conduct field trials of Bt maize. However, the voices coming from the agri-biotech industry are very clear this time. The industry wants the government to come up with a clear mandate and allow Bt crops in India. The Indian Maize Development Association (IMDA) expressed its apprehensions over the decision. Dr Sain Dass, president, IMDA said, “With the success maize has achieved over the years and with the potential the crop has to offer, there is significant scope to repeat the Bt cotton story with maize and put India on the world Bt map.” The Association of Biotechnology Led Enterprises-Agriculture Group  (ABLE-AG) while labeling the development as unfortunate, observed that the  industry will continue to engage in constructive dialogue with several regulatory authorities, including GEAC, Department of Biotechnology, State Agriculture Universities and farmers amongst others to develop technologies and products in India that are important and relevant to the country’s agriculture needs. “We are confident that our country’s science-based regulatory system will continue to support research-led innovations in agriculture and will help improve crop productivity, thereby benefitting Indian farmers, consumers, environment and our nation as a whole,” said VR Kaundinya, Chairman, ABLE-AG. The safety of Bt maize has been established through detailed tests and studies. So what seems to be the problem with Bt maize in Indian? Industry experts are baffled at the fact that decisions surrounding Bt maize are being taken due to political interference and not based on scientific reasoning.   Many independent bio-agri consultants like Dr TM Manjunath believe that  regulatory committees comprise eminent scientists who use their collective knowledge and wisdom in taking a decision on such issues based on science. “Our politicians are best advised to be guided by the eminent scientific bodies on such issues and not misled by self-styled environmentalists.” says Dr  Manjunath, who is a consultant at Agri-Biotechnology & Integrated Pest Management. Raising far more serious questions, Dr KK Narayanan, managing director, Metahelix, asks, “How can we afford not to have the latest technologies in this crop? The sudden halting of the trials instills further uncertainty in the road towards commercializing of not just Bt maize, but all other crops as well. Unless there is a clearly laid out path towards commercial utilization of the outcome of such investments, all investments will amount to a mere waste of the nation’s resources and scientific talent.” However Dr B Mazumdar, vice-President, Bejo Sheetal Seeds takes this as an isolated case. Dr Mazumdar says, “This is a special case and we feel that this is not generalized directive for all the GM trials.” The increased productivity in maize can turn India into a dominant exporter of maize particularly in Asia due to low cost of production and advantages in transportation. Therefore, it is high time for the Indian government to clear the air on Bt crops because it cannot continue to overlook the aspirations of the Indian agri-biotech industry. Rahul Koul in New Delhi ]]> <![CDATA[Ms Acharya honored as Young Global Leader]]> https://biospectrumindia.com/news/95/1806/ms-acharya-honored-as-young-global-leader.html https://biospectrumindia.com/news/95/1806/ms-acharya-honored-as-young-global-leader.html Tue, 12 Apr 2011 16:53:00 +0530 Ocimum Biosolutions’ founder and CEO Ms Anuradha Acharya has been honored as a 2011 Young Global Leader (YGL) by the World Economic Forum. The honor, bestowed annually since its inception in 2004, acknowledges 100-200 excellent young leaders from across the globe for their professional achievements, commitment to society at large and prospective contribution to shaping the global future. Ms Acharya is now a member of the Forum of Young Global Leaders that works in tandem with the World Economic Forum towards discovering innovative solutions to current global challenges while building the next-generation leadership community. On receiving the award, Ms Acharya said, “I am honored and thrilled to be part of the Young Global Leaders community of the World Economic Forum. The YGL platform is a powerful peer group that will enable us to contribute more effectively to the future of the world. I am looking forward to being actively involved in YGL” Voice your concerns to the new BT secretary Mr Vidyashankar IT, BT secretary of Karnataka Mr MN Vidyashankar has taken additional charge as principal secretary of Information Technology, Biotechnology and Science & Technology, Karnataka since March 8, 2011. This is in addition to his responsibilities at the Department of Personnel & Administrative Reforms (DPAR).  Mr Vidyashankar had held the same position for a brief period three years ago. He succeeds Mr Ashok Kumar Manoli, who has moved on as principal secretary, revenue. After a recently concluded Vision Group meeting held under the leadership of Dr Kiran Mazumdar-Shaw at Biocon, Mr MN Vidyashankar met up with the members of India’s leading biotech industry association – Association of Biotechnology-led Enterprise. His objective was to interact with the industry and understand the areas of concern and roadblocks that need to be addressed. With a progressive policy in place in Karnataka the key now is smooth execution. And there certainly are challenges to be met – most important of these include creating awareness about the policy and bridging communication gaps that exists between various government departments involved in executing this. Unraveling bacterial genetics Dr Joshua Lederberg (1925–2008) A prodigy as a youth, Dr Lederberg was 33 when he won the Nobel for Physiology or Medicine for discovering that bacteria can mate and exchange genes. He was one of the youngest Nobelists, sharing the 1958 prize with Mr Edward L Tatum and Mr George Beadle for their discovery at Stanford in the 1940s that genes act by regulating specific chemical processes. Dr Lederberg’s discovery that bacteria engage in sex created new understandings of how bacteria evolve and acquire new traits. A founder of molecular biology, he helped lay the foundations for many biological revolutions, including biotechnology. ]]> <![CDATA[India scales up efforts to control TB]]> https://biospectrumindia.com/news/95/1858/india-scales-up-efforts-to-control-tb.html https://biospectrumindia.com/news/95/1858/india-scales-up-efforts-to-control-tb.html Tue, 12 Apr 2011 16:52:00 +0530 The Indian government has given a go ahead to the proposal mooted by the Ministry of Health and Family Welfare for scaling up services for controlling tuberculosis. These include the diagnosis, care and management of drug resistant tuberculosis under Revised National TB Control Program (RNTCP). The project with an estimated cost of $144 million (649 crore) has an assistance from the Global Fund. With the scaling up of diagnosis, care and management services for multi-drug resistant TB (MDR-TB), the RNTCP shall establish 43 state-of-the-art laboratories using latest diagnostic technologies throughout the country. The project shall also scale up care and management of MDR-TB in the country resulting in the initiation of treatment of 55,000 cases. The project is expected to get completed by September 2015. The reports have shown that with the implementation of RNTCP the estimated rate of TB prevalence is on the decline in India. According to the WHO Global TB Report, 2009, the TB prevalence in India is currently 185 per lakh population as compared to 283 per lakh population in the year 2007. Periodic prevalence surveys conducted under the model of Directly Observed Treatment Short-course (DOTS) project by Tuberculosis Research Center (TRC), Chennai, has shown a 12 percent annual decline in TB prevalence. To control TB, the RNTCP, widely known as DOTS, which is a WHO-recommended strategy, is being implemented as a 100 percent Centrally-Sponsored Scheme in the country with an objective of detecting at least 70 percent of the estimated New Sputum Positive cases in the community and treatment success rate of at least 85 percent. THSTI, IAVI to develop HIV vaccine The Gurgaon-based Translational Health Sciences and Technology Institute (THSTI) and The International AIDS Vaccine Initiative (IAVI) will jointly establish, operate and fund an HIV Vaccine Design Program. This program will focus on one of the greatest scientific challenges of AIDS vaccine design and development: the elicitation of antibodies capable of neutralizing a broad spectrum of circulating HIV variants, a problem that stems in large part from the almost unparalleled mutability of HIV. The HIV program will capitalize on recent research advances that have sparked a renaissance in AIDS vaccine R&D. In September 2009, scientists at IAVI and their colleagues in the Neutralizing Antibody Consortium (NAC), which is overseen by IAVI, reported the isolation of a pair of potent and very broadly neutralizing antibodies against HIV. That discovery, the first-of-its-kind in a decade, was followed by the isolation of other broadly neutralizing antibodies (bNAbs) by researchers at the Vaccine Research Center of the US National Institutes of Health and by the IAVI affiliated team. The most promising of these antibodies are now being scrutinized by researchers to elucidate the specific mechanisms by which they bind and neutralize HIV. The idea is to create artificially-synthesized mimics of their targets on HIV, to be used in vaccines to elicit similarly potent bNAbs and teach the immune system how to thwart HIV infection. Government steps in to control cancer epidemic The Government of India has reformulated a National Program for Prevention and Control of Cancer, Diabetes, Cardiovascular Diseases and Stroke (NPCDCS) for the remaining two years of the 11th Five Year Plan. As per the Population-Based Cancer Registry, functioning under the National Cancer Registry Program of the Indian Council of Medical Research (ICMR), it is estimated that at any given point of time, there are 28 lakh cancer patients in the country. Further, as per the report of Indian Council of Medical Research (ICMR) on 'Time Trends in Cancer Incidence Rates (1982-2005)', the number of cancer patients is growing over the years at an average of approximately 1.2 percent per year.  The new program envisages prevention and control of common non-communicable diseases (NCDs) including cancer, through behavior and life style changes; build capacity at various levels of healthcare for prevention, diagnosis and treatment of common NCDs; train human resource and establish and develop capacity for palliative and rehabilitative care. Under the program, diagnostic services, basic surgery, chemotherapy and palliative care to cancer patients at 100 districts across 21 states are being provided. The central government is also supplementing the efforts of the state governments by focusing on early detection of cancer, health education and creating awareness through print and electronic media. New DBT, ICMR guidelines for probiotics Probiotics are the live microorganisms that live inside the human body and confer health benefits. The globalization of food trade has followed the Indian markets with many of probiotic products. In order to safeguard the consumers from any adverse effects, Indian Council of Medical Research (ICMR) and Department of Biotechnology (DBT) have framed guidelines to ensure standardization of commercial products and their efficacy.  A 10-member task force was constituted under the chairmanship of Dr NK Ganguly, president, JIPMER, Puduchery and former director general of ICMR, to deliberate on the issues regarding probiotics. Dr MK Bhan, secretary, DBT, said, “The ICMR-DBT guidelines comprehensively address various concerns regarding safety, efficacy and reliability as well as labeling of probiotic products being sold in India. I hope the scientific community, the regulatory agencies and the public at large will be benefited by these guidelines” The report also quotes Dr VM Katoch as saying that the guidelines have been developed for scientific purpose with the main aim to guide the regulatory authority for evaluating probiotic products in India. “I hope that these will also stimulate thinking among scientists interested in developing this area in India,” said Dr Katoch. The global probiotic market generated $15.9 billion in 2008 and is expected to be worth $32.6 billion by 2014 with a compound annual growth rate of 12.6 percent from 2009 to 2014. On the other hand, the probiotic product industry in India was estimated to be around $461,116 with a projected annual growth rate of 22.6 percent until 2015. With these kind of guidelines in place, it is expected that the regulatory authorities will ensure that the general public is not taken for a ride. GOI sets up task force for pharma The Indian Ministry of Health and Family Welfare has constituted a task force to evolve a long-term strategy for addressing various issues faced by the Indian pharma industry. This comes after the leaders of the pharma industry strongly requested the Union Health and Family Welfare Minister, Mr Ghulam Nabi Azad, to constitute a task force to prepare a long-term strategy for strengthening the drug sector in the country and look into matters concerning medical devices, clinical research organizations and R&D labs. The task force that will submit its report within three months has the mandate to evolve a short, medium and long-term policy and strategy to make India as a hub for drug discovery and R&D. The task force will recommend measures to tackle the problem of spurious drugs, use of anti-counterfeit technologies, and devise roadmaps for implementation of all recommended measures. The task force will bring out policy measures to promote indigenous production of bulk drugs, prevent take over of Indian pharma companies by MNCs, drug pricing, promotion of generic drugs and recommend measures to assure adequate availability of quality generic drugs at affordable prices. Himachal biotech park gets green signal After the clearance from the state government and assistance from the central government, the biotech park at Himachal Pradesh will soon become a reality. The 35-acre biotech park is expected to capitalize on the Himalayan bioresources. Besides boosting the employment and other financial requirements of the region, the state-of-the-art park is also expected to attract investors from India and abroad. The park will be set up at Aduwal village near Nalagarh in Solan district and will have a biotechnology incubation center and a biotechnology industrial cluster. The Chief Minister of Himachal Pradesh, Mr Prem Kumar Dhumal, revealed that the Himachal government is looking for a partner to develop a multi-billion biotechnology industry park, under public-private-partnership (PPP) mode. Speaking to BioSpectrum, Dr Nagin Nanda, director, Department of Environment, Science and  Technology, Government of Himachal Pradesh, said, “We have invited the financial and technical responses for the biotech park project and six companies have responded to the technical bid process. This is a tripartite process in which the central government, Himachal Pradesh government and the private developers are involved.” ]]> <![CDATA[IVRI transfers technologies to Hester]]> https://biospectrumindia.com/news/95/2498/ivri-transfers-technologies-to-hester.html https://biospectrumindia.com/news/95/2498/ivri-transfers-technologies-to-hester.html Tue, 12 Apr 2011 16:50:00 +0530 The Indian Veterinary Research Institute (IVRI), Uttar Pradesh, has transferred two potential technologies to Gujarat-based Hester Biosciences, a leading poultry manufacturing company, for commercialization. These technologies from IVRI include a PPR vaccine and Goat Pox vaccine that have been directly commercialized through Zonal Technology Management- Business Planning and Development Unit (ZTM-BPD Unit). The institute is also offering various other veterinary vaccine and diagnostic technologies for commercialization. The demand for veterinary vaccine and diagnostics are increasing and many commercial houses are contacting IVRI for the technologies. Prof MC Sharma, director and vice chancellor, IVRI, said, “IVRI as distinguished institute in Indian Council for Agricultural Research (ICAR) has a glorious history of 120 years in veterinary immune-biologicals. Recently, the Veterinary Business Incubator laboratory has been established at IVRI and this is the first business incubator in veterinary sciences in the world. Hester Biosciences has also shown interest to take the business incubator laboratory at IVRI.” Considering the potential of technology commercialization and business incubation, ICAR has selected IVRI and established ZTM-BPD unit for technology commercialization, IP management and entrepreneurship development in ICAR North Zone II. The ZTM-BPD Unit extends its services to 20 ICAR institutes of animal sciences, crop and horticultural sciences, natural resource management and fisheries. Stem cells shrink enlarged hearts Researchers have shown for the first time that stem cells injected into enlarged hearts reduced their size, reduced scar tissue and improved function to injured heart areas, according to the research report published in Circulation Research: Journal of the American Heart Association. Researchers said that while this research is in the early stages, the findings are promising for people suffering from enlarged hearts due to damage sustained from heart attacks. Options for treatment are limited to life-long medications and major medical interventions, such as heart transplantation. Using catheters, researchers injected stem cells derived from the patient's own bone marrow into the hearts of eight men (average age 57) with chronically enlarged, low-functioning hearts. Heart size decreased an average of 15-20 percent, which is about three times what is possible with current medical therapies. There was dramatic improvement in the function, or contraction, of specific heart areas that were damaged. The researchers had used two different types of bone marrow stem cells in their study — mononuclear or mesenchymal stem cells. All patients in the study benefited from the therapy and tolerated the injections with no serious adverse events. New gene therapy reverses Parkinson’s Neurologix has announced that the results of the company's phase II clinical trial for its novel, investigational gene therapy NLX-P101 for the treatment of Parkinson's disease (PD) were published in an online edition of The Lancet Neurology. The randomized, double-blind, sham surgery-controlled trial of 45 subjects with advanced PD met its primary outcome measurement for efficacy and demonstrated that NLX-P101 gene therapy was safe and well-tolerated over the six month blinded study period. Study results show that NLX-P101 treatment led to a mean 23.1 percent improvement (8.1 points) in off-medication Unified PD Rating Scale (UPDRS) motor score at the six-month study end-point, compared to a mean 12.7 percent (4.7 points) improvement with sham treatment. Study results also show that 50 percent of subjects treated with NLX-P101 achieved previously defined moderate-to-large clinically-meaningful symptom improvements (> / = 9 points in UPDRS), as compared to just 14 percent of subjects who received a sham surgical treatment (p=0.03). No serious adverse events (SAEs) related to the gene therapy or surgical procedure were reported. This is the first phase II study conducted under a rigorous randomized, double-blind, sham-controlled surgical design to conclusively demonstrate that gene therapy can be effective for neurological diseases. ]]> <![CDATA[Similar biologics: A field concern]]> https://biospectrumindia.com/news/95/6196/similar-biologics-a-field-concern.html https://biospectrumindia.com/news/95/6196/similar-biologics-a-field-concern.html Tue, 12 Apr 2011 16:47:00 +0530 Dr Rajneesh Kumar Gaur is Scientist C at the Department of Biotechnology, New Delhi Pharmaceutical companies protect their innovative molecules of either chemical or biological origin through patent to ensure the market exclusivity. Once the patent is expired, the molecule is open for manufacturing and marketing by any pharma or biotech company other than the one who discovered it. Such off-patented drugs of chemical origin are called as ‘generics’, while those of biological origin are popularly designated as ‘biosimilars’. Worldwide, biosimilars have many synonyms such as ‘Follow-on-biologics, in the US’, ‘Subsequent entry biologics, in Canada’ and so on. In India, the off-patented biologics produced via genetic engineering will be termed as ‘Similar biologics’ as proposed by the Review Committee on Genetic Manipulation (RCGM), Department of Biotechnology. In India, similar biologics are expected to have $1 billion market by 2020. In general, the biopharmaceuticals are mainly proteins having considerable therapeutic and structural diversity. Generics are easy to manufacture and standardize as the quantitative analysis is enough to ensure their bioavailability and bioequivalence. The manufacturing of biologics is affected from several process and product variations while producing them in a living cell. One of the major sources of these variations is that manufacturer of the similar biologics does not have access to the original manufacturer process even after expiry of the patent. Therefore, homogenous production of similar biologics would be difficult as a result of possible variations introduced due to several factors such as host cell, vector, fermentation medium, protein folding, post-translational modifications, and protein stability. These subtle differences may affect either the efficacy or tolerability or both of a product. Similar biologics are approved for marketing based on the data which shows ‘high similarity’ to the reference innovator product in terms of quality, safety and efficacy. No regulatory authority in the world including the US Food and Drugs Administration (FDA) and European Medicines Agency (EMA) defined the range of similarity between a similar biologic and the respective innovator reference product. FDA indeed approved few products on the basis of bioequivalency when a similar biologic has its 90 percent confidence interval between 80-125 percent with respect to the reference innovator product. FDA also introduced a separate labeling requirement to differentiate between the innovator original product and its biosimilar. The proper labeling provides an easy route for the physicians in the US to easily record the lower efficacy or unexpected outcome of a biosimilar product. Simultaneously, the interchangeability or the substitution of an innovator original product with biosimilar may be regulated smoothly. EMA states that the physicians should specify the International Non-proprietary Name (INN) or brand name. This hinders generic prescribing and substitution. In India, Drug and Cosmetics Act, 1940 does not have any special labeling requirement for distinguishing between a similar biologic and innovator reference product. Therefore, physicians and patients will find it hard to distinguish between a similar biologic and the reference product. The problem will further aggravate in the absence of an adequate and effective mechanism to regulate the safety as well as efficacy of approved similar biologics on-field. Also, the possible unwanted clinical outcome of a similar biologics as a result of pharmacogenomics variation in an Indian population will be extremely tough to assess. Such outcomes may be extremely severe either locally or at larger scale. Another related on-field concern is after getting the market authorization; the pharmaceutical companies might dilute the quality of a similar biologics. There is a fear that companies might push such substandard similar biologics in remote areas having no surveillance machinery and even the media does not have good penetration. On the top of that, the greed for greater margin will help in pushing such substandard drugs. The continuous exposure to sub-standard drugs might lead to the development of either tolerance or resistance at a faster pace than expected. Therefore, India needs to consider all these negative traits and their possible harmful consequence. To tackle such issues, we require a very well-defined pathway to regulate the quality, safety and efficacy of similar biologics after market authorization and also to ensure the benefits of their lower price to the consumers. In other words, strong pharmacovigilance program is desirable. The million dollar question is that does the government have the machinery to execute this mammoth task? The Central Drugs Standard Control Organization (CDSCO) has initiated a national Pharmacovigilance Program of India (PvPI). The program will be completed by 2013 in three phases. The program will operate through routine collection of clinical data for drugs of chemical and biological origin at local medical colleges and pooling the data at a nodal center i.e., AIIMS, New Delhi, for final evaluation and decision-making. The post-marketing monitoring of similar biologics may be facilitated under the same program. The guidelines for similar biologics will come into effect this year, so there is a gap of at least two years till the PvPI may contribute in real terms. Meanwhile, the companies may take profitable advantage of this gap. Therefore, the Indian regulatory authority should make provision for random testing of market authorized similar biologics in any national laboratory. Such measures will certainly reduce the ambiguity, confusion and apprehensions about the similar biologics among the medical practitioners and their clients. (The views expressed by the author in this article are personal and have no relation with the official position of the Department of Biotechnology, Ministry of Science and Technology, New Delhi) ]]> <![CDATA[Indian firms strengthen diagnostics segment]]> https://biospectrumindia.com/news/95/8108/indian-firms-strengthen-diagnostics-segment.html https://biospectrumindia.com/news/95/8108/indian-firms-strengthen-diagnostics-segment.html Tue, 12 Apr 2011 16:43:00 +0530 Diagnostic kits are crucial for tracking and treating diseases. In this edition of CSO series, BioSpectrum highlights the achievements of Dr Shama Bhat, founder and chairman of Bhat Bio-Tech; and Dr Pradip Desai, founder and chairman of Span Diagnostics Diagnosis is the first step in identifying the cause of any disease. Hence correct diagnosis is an obvious pre-requisite for planning any strategy for prevention, treatment or mitigation of diseases; increasing the effectiveness of treatment; and reducing the therapeutic turnaround time. Furthermore, diagnosis is also performed to reduce uncertainty related to a suspected disease condition. A fairly confident diagnosis can sometimes be made on the basis of clinical signs or symptoms alone, but accurate diagnosis usually requires a specific diagnostic test, often involving access to a diagnostic laboratory. Diagnostic tests have a key role in patient management and identifying most appropriate antibiotic to be used for treatment of infectious diseases. As compared to earlier times when the patients were treated on the basis of clinical symptoms, today doctors are equipped with diagnostic results to find out the root cause of any disease. This also helps the doctor to track the disease progression and relapse. Therefore, to offer cost-effective diagnostics solutions for people in resource-poor areas, developing and launching diagnostics for world's neglected diseases such as tuberculosis, syphilis, cholera, filaria, kala-azar, plague and malaria is a great responsibilty. The diagnostic companies in India have come a long way over the decades. There are a lot of indigenous companies that have made a significant difference in the diagnostic sector. Companies such as Bhat Bio-Tech, Span Diagnostics, Tulip Diagnostics and XCyton Diagnostics are the few prominent names in this space. The total number of clinical laboratories in India is said to be in between 38,000 and 40,000. Companies such as Bhat Bio-Tech have developed innovative methods to cut down the cost by using indigenous reagents. For example, for making the HIV kits we need HIV antigens. HIV antigens imported from the US will cost about $123 (5,500) per mg. To make the same antigen in-house, it will cost less than $2.2 (100) per mg. When Bhat Bio-Tech started marketing pregnancy kits in 1996, it was priced at $1.1 (50) per test to the distributors and now it is being sold at less than $0.15 (7) per test. Similarly, another example is of Span Diagnostics, which has been supplying the HIV test kits for National AIDS Control Program for the last eight years and malaria test kits for Malaria Control Program for the last five years.  However, it is also evident that in-vitro diagnostics (IVD) accounts for only three percent of overall healthcare spending. Dr. Shama Bhat Dr Pradip K. Desai ]]> <![CDATA["Our R&D emphasis is to develop automated platforms"]]> https://biospectrumindia.com/news/95/1082/our-rd-emphasis-is-to-develop-automated-platforms.html https://biospectrumindia.com/news/95/1082/our-rd-emphasis-is-to-develop-automated-platforms.html Tue, 12 Apr 2011 16:42:00 +0530 Dr Pradip K. Desai founder chairman & director Leaving his flourishing career as clinical pathologist, Dr Pradip Desai decided to turn into an entrepreneur and the time has proved he was right. After receiving his MBBS degree in 1961 and MD (pathology) in 1965, Dr Desai started his career in 1966 as a clinical pathologist in Surat, Gujarat. Arising out of necessity perceived by the frustrating experience due to highly-restrictive import policy with punishing levels of custom duty prevailing in 1970s, Dr Desai was motivated to start a company named, Desai Clinical Laboratories, as a diversion from his busy and flourishing clinical laboratory practice. The company was renamed as Span Diagnostics in 1976. The goal was to indigenously develop and manufacture a comprehensive range of ready-made diagnostic products needed by clinical laboratories in India. From the beginning, emphasis was laid on in-house R&D to develop affordable products, keeping the customer need in focus and quality under constant vigil. Today, Span Diagnostics is one of the most reputed IVD manufacturing companies in India. Under his leadership, in the beginning Span Diagnostics offered diagnostic solutions for typhoid, tuberculosis, syphilis and blood grouping reagents, which were burning need of that era. Clinical chemistry reagents were given importance in 1980s. In early 1990s, Span introduced ELISA for HBsAg and HIV-1 which were the first indigenously manufactured commercial ELISA test kits in India. Thereafter Span licensed technology from PATH, US, and introduced rapid test for HIV in the comb format which have been used extensively by all segment of laboratory in last two decades and have greatly contributed to NACO’s efforts to control the spread of HIV. At present, the company's R&D focus is on upgrading the quality and performance of its existing products to maintain the parameters in line with the international standards. These efforts are further enhanced by collaborative development and licensing of technologies from reputed Indian Institutions such as AIIMS, Anna University and University of Delhi, South Campus as well as foreign Institutions such as PATH, US; CDC, US; and Pasteur Institute, France. Commenting on the future R&D plans of the company, Dr Desai says, “The focus is mainly on the point-of-care tests and molecular diagnostic tests. Since, automation and instrumentation is the demand of recent times due to its acknowledged role in reducing chances of human errors and increased efficiency, our R&D emphasis is on development of automated platforms on which HIV, HbsAg, HCV, and thyroid hormones can be tested by using the most sensitive measurement technologies. The IVD industry is in the inflection position and different business models are likely to emerge by multiplexing the technologies.” The dynamic leadership of Dr Desai helped Span Diagnostics to achieve remarkable growth in its overall performance for the financial year 2009-10. The revenue of the company has increased to $18 million (82 crore) in the year 2010 as compared to $5 million (207 million) in 2001. The company has strong presence in domestic market with blood banking, infectious disease, clinical chemistry and hematology products. It has more than 50 percent market share (in terms of number of tests) in HIV, HCV, tuberculosis, syphilis, typhoid and malaria. Span Diagnostics has significant market share in blood grouping reagents, clinical chemistry reagents, rheumatology and hematology. Rahul Koul in New Delhi ]]> <![CDATA["I left my job in the US and returned to India to do something"]]> https://biospectrumindia.com/news/95/1424/i-left-my-job-in-the-us-and-returned-to-india-to-do-something.html https://biospectrumindia.com/news/95/1424/i-left-my-job-in-the-us-and-returned-to-india-to-do-something.html Tue, 12 Apr 2011 16:40:00 +0530 Dr. Shama Bhat, founder, chairman and managing director The urge of doing something different than working as a professor or a scientist made Dr Bhat come to India and give wings to his entrepreneurial dreams. The thought of returning to India came into Dr Bhat's mind when he along with his wife Ms Susheela attended an AIDS conference in New Delhi in 1993. After having spent nearly 17 years in the US at University of Pennsylvania, it was not an easy decision for them. However, being aware that the diagnostic kits for the detection of HIV were unavailable in India at that time, Dr Bhat felt it was the best time to start a company for manufacturing diagnostic kits for HIV and other diseases. After discussing about this venture with two of his close friends, Dr Ramesh Bhat and Dr Krishna Bhat, he received their whole-hearted support. He went ahead and set up Bhat Bio-Tech India in 1994. Since he was working in the field of HIV, making diagnostic kits for HIV detection was not difficult. By the time he came to India he had these kits almost ready to be manufactured. As the promoter of Bhat Bio-Tech, Dr Bhat has leveraged his 35 years of experience in R&D and manufacturing in the biotechnology area, to conceive this enterprise. An alumnus of Kasturba Medical College, Manipal and the Indian Institute of Science, Bangalore, trained at the University of Connecticut Health Center, Farmington, US, Dr Bhat worked as the faculty at the Neurology Department, University of Pennsylvania, US, from 1983 to 1994. His discovery of Galactosyl Ceramide, as an alternative receptor for HIV in neural cells, won him both universal acclaim as well as the undivided attention of global scientific circles. He has over 40 publications to his credit and is a recipient of the prestigious Ranbaxy Award. According to Dr Bhat, the journey of Bhat Bio-Tech was bumpy in the beginning. After his return to India, he found it difficult to adjust himself to the bureaucratic set up after being in the US for more than 16 years.  Narrating the same, he says, “They blindly told me that, you may have good credentials and experience but for the paper work we need a collaboration from abroad, which will help in approving the loan immediately. I was shocked and had to argue with the authorities that I left a lucrative job in the US and returned to my homeland to do something and I'm ready to take the risk. I realized that the local authorities give much importance to the papers from abroad instead of evaluating how much our own people can do. Finally, the loan was sanctioned and Bhat Bio-Tech was set up in 1994.” Bhat Bio-Tech started with pregnancy test kit in 1996 and today, it has more than 100 kits for diagnosis of many diseases and conditions. The company that started with a handful of people, today under the leadership of Dr Bhat has more than 200 working people and more than 300 people benefited indirectly. In response to the recent epidemic of chikungunya and swine flu, Bhat Bio-Tech worked round-the-clock to bring out the diagnostic kit for chikungunya in about six months time. Similarly, when H1N1 was a national health threat, the company worked hard to bring a molecular level detection kit in record time, now waiting for the license from the drug authorities. At present, Bhat Bio-Tech is working on molecular diagnostics, pharmacogenomics, lab-on-a-chip for several parameters, diagnostics for veterinary, agriculture and food safety. The company is focusing on both protein-based and molecular biological methods for the development of diagnostic kits. Dr Bhat believes that despite pharmacogenomics, the so-called personal medicine, the major hospitals and big diagnostic centers will continue to use the automated machines for the diagnosis. Rahul Koul in New Delhi ]]> <![CDATA[Mahyco strengthens R&D activities for Bt crops]]> https://biospectrumindia.com/news/95/2689/mahyco-strengthens-rd-activities-for-bt-crops.html https://biospectrumindia.com/news/95/2689/mahyco-strengthens-rd-activities-for-bt-crops.html Tue, 12 Apr 2011 16:39:00 +0530 The vehement controversies surrounding the commercialization of Bt brinjal have not deterred scientists at the Mahyco Research Centre. They have actually accelerated their efforts by focusing on a host of highly specialized biotech research programmes A visit to Maharashtra Hybrid Seeds Company’s (commonly referred to as Mahyco) state-of-the-art R&D facility at Dawalwadi near Jalna, Aurangabad, will make any individual realize that the cornerstone of Mahyco’s success till date has been its strong, diverse and progressive R&D programmes. Owing to its ongoing emphasis on research, Mahyco has several innovations to its credit. Worldwide, Mahyco was the first company to successfully commercialize F1 hybrid cotton based on genetic and cytoplasmic male sterility systems. Mahyco was also the first company in India to produce and market hybrid sorghum, pearl millet and sunflower. Most importantly, it brought in a revolution in the Indian-agri community by commercializing India’s first Bt cotton (Bollgard I) and then a superior Bollgard II in 2006. The facility, which is called Mahyco Research Centre, was established in 1998 with the purpose of conducting cutting-edge biotechnology research in a number of areas relevant to crop improvement and productivity. Major research areas of Mahyco include crop transformation, molecular virology, molecular microbiology, gene discovery, molecular markers, entomology and diagnostics. To monitor particular protein content in genetically modified (GM) crops, it established DesiGen Diagnostics, which provides diagnostics solutions for GM crop testing for research scientists, seed producers and farmers. This division today manufactures two kinds of kits — Elisa Kits for Cry1AC and Cry1Ab gene and Bt gene detection strips. “The technologies and traits that we work on cuts across all crops” — Dr Usha Barwale Zehr, director-research at Mahyco Spread across 110 acres, the Mahyco Research Centre has 160,000 square feet of wet lab space and boasts of nine biotechnology labs. “We had our first biotechnology lab based out of Bangalore in 1986, but later realised that biotech research needs to be centralized. Hence, these labs were shifted to Jalna because in biotech, the technologies and traits that we work on cuts across all crops,” says Dr Usha Barwale Zehr, director-research at Mahyco. The R&D team in this center focuses on field crops like wheat, rice and cotton, vegetable crops like okra, brinjal, cauliflower, tomato, cabbage, radish and potential crops like soyabean, sugarcane and potato. The company is also working upon a number of traits to improve crop productivity. “Presently we are working on insect tolerance (sucking and chewing pest), herbicide tolerance, salinity tolerance, drought resistant seeds, nitrogen use efficiency and resistance against disease and virus,” says Dr Bharat Char, head of biotechnology research at the Mahyco Research Centre. Research activities have become highly specialized due to which the company is in a continuous process of upgrading its labs with the latest high-end technology not just to increase yield but also to discover traits which can help a crop battle against insects and diseases. “The cycle is such that insects and pests develop a resistance to even Bt crops after a period of time. Hence, it is very important that we upgrade our technologies in discovering new traits and metholodologies for crop productivity,” informs Dr Zehr. The company is in the process  of making considerable investments into molecular makers for their molecular and biotechnology experiments. “High-end molecular makers help our scientists to diagnose genetic traits in a plant(s) in a short span of time and this in a way greatly reduces the time of bringing the product to the market,” adds Dr Zehr. For DNA extraction, molecular breeding labs utilize robotic automation systems, which can take in a large number of plant samples at one time and at high thoroughput speed. While the molecular breeding labs diagnose gene traits in a plant, the molecular biology lab is even more specialized as it discovers particular traits in a plant against insects like chewing and sucking pest and even traits like salt and drought resistance. The plant transformation labs (wherein the gene is transformed to the plant) looks into both vegetable and field crops. The lab is developing a vast array of biotechnology approaches to develop insect and disease resistant crops. These biotechnology methods will be examined in rice, okra, tomato, brinjal, cauliflower and cabbage. Scientists at the Mahyco Research Centre are also looking at using GM technology to modify expression pattern of a plant’s own gene with the aim that the plant/crop uses and absorbs a large amount of nitrogen from the soil. These highly specialized research programmes are the brainchild of a group of highly qualified pool of scientists and technicians working at this center. The management attributes that being a research driven company, they are extremely particular about bringing on board highly qualified scientists. “Most of our scientist have foreign PhDs with 3-5 years of post doctoral experience abroad. All our PhDs are mainly from the US,” adds Dr Zehr. Going forward, the industry will see a host of exciting programmes coming out from this centre. Apart from expanding on its hybrid business, the centre is gearing up for bring out the RR (Roundup Ready) cotton, Bt brinjal and discovering new traits in crops. Looking at the vast spectrum of research programmes, which the company is currently engaged in, there will be an additional 30,000 square feet of laboratory space added in the coming  months. Nayantara Som in Dawalwadi, Maharashtra ]]> <![CDATA[Mission: Tapping into traditional medicine]]> https://biospectrumindia.com/news/95/1222/mission-tapping-into-traditional-medicine.html https://biospectrumindia.com/news/95/1222/mission-tapping-into-traditional-medicine.html Tue, 12 Apr 2011 16:29:00 +0530 SBIRI funding has boosted the joint venture of Goa-based MykoTech and Asthagiri Foundation. It aims to tap the potential of herbal medicine Traditional medicine has always been at the core of Indian medical system and the need to leverage natural products has always been there. While working in this direction, Goa-based MykoTech  and Asthagiri Herbal Foundation (AHRF) teamed up with an aim to develop more effective bioactive compounds from known active principles of medicinal plants through biotransformation. The company initiated a project on synthesis of novel molecular drugs through biopolymerization of active principles from medicinal plants using the laccase enzyme. Though the concept was generated at MykoTech, AHRF standardized the use of the enzyme for biotransformation and also achieved similar results with numerous compounds. MykoTech, which became operational in 2005, was started by Dr Seshagiri Raghukumar, a former scientist at the National Institute of Oceanography (NIO), Council for Scientific and Industrial Research (CSIR), Goa. The company was started with the aim of culturing rare and novel fungi from tropical forests of India and examining these for various biotechnological applications. Besides being the possessor of a culture collection of more than 1,000 fungi and several bacteria, R&D was initially the sole focus of MykoTech and that has been supported by investors in the company, consultancy and contract research. One major technology that the company has developed is that of extracellular melanin production by a fungus, for which a patent has been filed. The company finds itself lucky to have received funds for its biotransformation idea from the Small Business Innovation Research Initiative (SBIRI). Dr Raghukumar, who worked at the NIO from 1982 to 2005, says, “We believe that SBIRI is a shining example of PPPs. This could be enlarged to include equity investment in start-up companies. An agency to provide market research for start-ups will be an additional advantage.” Talking about the objective behind the project, Dr Raghukumar says, “We see innovation as the most important aspect that will help new companies to overcome the intense competition that exists in biotechnology industries. We came up with the idea of developing more effective bioactive compounds from known active principles of traditional, medicinal plants through biotransformation. We believe that this is a novel approach and have filed a provisional patent for the process.” The Way Forward MykoTech is confident that innovative technologies could be developed by studying novel and unique microbes. Currently, the work on the anti-cancer and anti-diabetic assays are in progress at MykoTech. The compound has tremendous potential for use in cosmetics, as a gamma-radiation protectant and also in research. Now the focus of the company is to carry out more research before the usefulness of these biotransformed compounds can be confirmed. Rahul Koul in  New Delhi ]]> <![CDATA[Mission: Enhancing drug delivery capabilities]]> https://biospectrumindia.com/news/95/1761/mission-enhancing-drug-delivery-capabilities.html https://biospectrumindia.com/news/95/1761/mission-enhancing-drug-delivery-capabilities.html Tue, 12 Apr 2011 16:27:00 +0530 Aiming to devise a novel formulation based on nanobiotechnology, Jupiter Bioscience along with MS Baroda University fosters a unique PPP model One of the crucial part of drug discovery research is the targeted and timely delivery of the drugs. Hyderabad-based Jupiter Bioscience initiated a project on the development of anti-cancer chemotherapeutic agents for effective treatment of lung cancer. The company’s efforts received a major boost after it received funding worth of $303,013  (1.35 crore) from the Small Business Innovation Research Initiative (SBIRI) scheme of the Department of Biotechnology (DBT), Government of India. The project is focused on the development, optimization and characterization of ligand (RGD peptides) targeted nano-constructs encapsulating anti-cancer chemotherapeutic agents (Gemcitabine) for effective treatment of lung cancer. The company combined its strength in the area of formulation with the expertise of  Prof Ambikanadan Mishra, an expert from the MS Baroda University. Applying Prof Mishra’s expertise in the field of nanotechnology-based drug delivery to the lung disorders, the company created an excellent mix to create novel product related to advanced formulation. Jupiter Bioscience, which was founded by the late Mr KS Sarma, was incorporated in 1985. The company went public in 1995 and is presently led by Mr Venkat Ramana Kalavakolanu, son of Mr Sharma, who is the chairman and managing director of the company. The company has developed and currently sells more than 600 raw materials and intermediates used in peptide research and commercial applications. With the recent introduction of peptide formulations by its subsidiary, the company has achieved the status of an integrated manufacturer of peptides. Commenting on SBIRI funding, Mr Kalavakolanu, says, “PPP is the only way to execute projects which involve considerable risks and the impact of risks is partly borne by receiving support from the government in terms of financial assistance. Moreover, the right mix of expertise from the industry and  academia is possible only through PPPs.” According to the company, formulating these nano-constructs into novel formulation will target the cancer cells without affecting the normal cells, thereby reducing the side-effects. The stabilization of lypophilized or spray-dried formulation for direct local delivery or by injection through systemic circulation is expected to improve therapeutic benefits of lung cancer treatment. The Way Forward The main goal of the project is the encapsulation of drugs inside the nano-constructs to enhance cellular uptake and reduce macrophages uptake and ciliary clearance in the lung. Since Jupiter has a strong peptide background, the company succeeded up to three stages in the development of Arginine-Glycine-Aspartate (RGD) peptide. Recently, the company synthesized the substrate (RGD peptide), which is useful for targeting the lung cancer cells. The company made the nano-construct in partnership with Prof Mishra of the MS Baroda University. The company will also prepare the peptide conjugated nano-construct and encapsulate the gemcitabine, which is a lung cancer drug. Rahul Koul in  New Delhi ]]> <![CDATA[Mission: Develop import substitute of phytase enzyme]]> https://biospectrumindia.com/news/95/1677/mission-develop-import-substitute-of-phytase-enzyme.html https://biospectrumindia.com/news/95/1677/mission-develop-import-substitute-of-phytase-enzyme.html Tue, 12 Apr 2011 16:25:00 +0530 MAPS Enzymes has successfully utilized DBT funding to develop import substitute for phytase enzyme The Phytase enzyme  has numerous  industrial applications including animal feed applications, dietary supplements and food processing among others. To provide an alternative to the imported version of the enzyme, Ahmedabad-based MAPS Enzymes has successfully utilized the funding received from the Small Business Innovation Research Initiative (SBIRI) scheme of the Department of Biotechnology (DBT). The project, on the development of a cost effective process for phytase production and its application studies handled by MAPS Enzymes, aims to produce cost-effective phytase enzyme. The aim was to cater to the needs of the animal & poultry feed market and also to provide import substitute of phytase enzyme products to meet the upcoming market requirements.  The company received SBIRI funding through the Biotech Consortium India Limited (BCIL), New Delhi, as per the requirements of the project. Funds worth $22,991 (10.24 lakh) were provided as grant and $19,085 (8.50 lakh) was given as a loan for the project. From its humble beginning in 1975, today MAPS Enzymes is one of the top 1,000 national private business groups and is amongst the top 50 biotech companies in India. With a current turnover of $4.4 million (20 crore) coming from its biotech business, MAPS has emerged a pioneer in producing enzymes and microorganisms. MAPS provides biotech solutions for various industrial applications using the most sophisticated fermentation technologies to develop innovative and effective enzymes and microorganisms. With an advanced production plant and a dedicated R&D center, MAPS is India’s one of the largest producer and exporter of enzymes and microorganisms and a leading player in the global market. Appreciating the support of DBT’s SBIRI scheme, Mr Piyush Palkhiwala, chairman & managing director of MAPS, says, “We appreciate the PPP initiatives to facilitate the biotech industry. We believe that it will strengthen those existing private industrial units whose product development is based on in-house innovative R&D and also encourage other smaller businesses to increase their R&D capabilities and capacity. It will create opportunities for starting new technology-based or knowledge-based businesses by science entrepreneurs. The funding definitely helped in increasing the pace of efforts to create an indigenous product.” The Way Forward The company has concluded a project on the cost effective process for phytase production and its pilot level application studies. Now looking forward to the higher plans, Mr Palkhiwala says, “Currently, we are marketing and commercializing the product in Indian and global markets.” Today, MAPS works with industries worldwide in providing advanced biochemical treatment technologies and extensive technical services for providing innovative solutions, increasing productivity, improving profitability and safeguarding the environment. With a sales network spread across 20 countries, MAPS provides biotech solutions to improve industrial performance and quality while at the same time saves water, energy and raw materials. Rahul Koul in  New Delhi ]]> <![CDATA["We aim for 30% growth in next few years"]]> https://biospectrumindia.com/news/95/6546/we-aim-for-30-growth-in-next-few-years.html https://biospectrumindia.com/news/95/6546/we-aim-for-30-growth-in-next-few-years.html Tue, 12 Apr 2011 16:24:00 +0530 Mr Hari Kumar CEO,  JH Bio Innovations, Bangalore JH Bio Innovations, a company that supplies laboratory instruments for life sciences, biotechnology, molecular diagnostics and environmental sciences in India, has been representing many leading companies such as DAIHAN Scientific, Thermo Fisher and Evogen. The company has significant market share in imaging systems and micro volume spectrometers and it took many initiatives to emerge as a key player in the entire range of UV-VIS spectrometer market. Recently, JH Bio introduced ‘EVOS’ branded digital microscopes from Advanced Microscopy, US. In an interview with BioSpectrum, Mr Hari Kumar, CEO,  JH Bio Innovations, shares details about company's product pipeline and future plans. Q What are the new products introduced by JH Bio in India and how was the industry response for those products? We have recently introduced ‘EVOS’ branded digital microscopes from Advanced Microscopy, US. This product is so elegantly designed that it attracts the attention of people when it is placed in the middle of other instruments. The product is designed keeping in view parameters such as  ergonomics, ease-of-use, multi-view  and flexibility. We are getting very good feedback from the customers. For the first time in the history of our company, we are able to close over eight units of orders from prominent institutions such as CDFD, IISER, ANGRUE, and IGIB within two months of the product launch. We are very excited about this product. Q Looking at the growth of the biotechnology industry, how do you see the growth of JH Bio in the coming years? We were growing at an average of over 50 percent from the year 2000 to 2008. Due to several external factors, including recession, our growth has stagnated in the last three years. However, now the economy has picked-up and in addition, the new product lines are going to bring us a growth of more than 30 percent over the next few years. Q Between public and private R&D activities, where do you see more growth? Due to the growth of India’s GDP at over 8.5 percent, there is a lot happening in the public sector. An exponential growth has taken place in the higher education space and several new initiatives that are taken through the Department of Science and Technology (DST) and Department of Biotechnology (DBT) are paving the way for a very good growth in the public sector. As the life sciences R&D sector as well as the industry have reached a critical mass, this is also going to enhance the growth. I expect it to grow at over 20-25 percent. The only reservation is about the effect that it will have due to earthquake and related problems and the political unrest in the north African countries and the Gulf region. Q What are your strategies for enhancing the growth of JH Bio? We  have a range of good products catering to the needs of molecular biology. With the introduction of EVOS microscopes, we are just starting to have a good range of products for the cell biology field. Imaging is going to be our focus area for the next level of growth. Q How do you view the global and local mergers and acquisitions happening in the biosuppliers space? India, as a business destination, is gaining more attention due to its technical capabilities, very good infrastructure facilities, and associated growth rates. The market consolidation in India, mainly through multinationals, is getting very rapid. All the multinational companies in India, will engage more local companies, and the small and medium-sized companies for establishing distribution network all across India. Q What is the threshold level the distributor firms should have to get the attention of multinational suppliers? Any distributor company with pan-India operations, would require a matrix of operations from 10-12 locations, 50-60 people and a business of $5.5-6.6 million (25-30 crore). Based on the size of the company and product lines, the multinationals will get attracted towards the local companies of the size mentioned above. Q On an average, how many distributors are there in India? As a close follower of the supplier activity reported in BioSpectrum as well as from different other sources in the market, there are five to six major, 20 to 30 medium and 100 to 120 small distributors in India. Q Considering the current trends in supplier space, is there a need for distributors to have an association or a lobby group? It is a very good point which I have been thinking for a long time. It is very much necessary for several reasons: to address the different issues with the principal companies; to initiate reforms in the purchase processes in the public sector; to work with the government for all the general issues that the supplier community have. Probably BioSpectrum could take an initiative in putting forward this idea to the biosupplier community and initiate a debate. It is always good to have an association for biosuppliers like ABLE for the life sciences industry. ]]> <![CDATA["We will reduce the cost of nucleic acid extraction"]]> https://biospectrumindia.com/news/95/5077/we-will-reduce-the-cost-of-nucleic-acid-extraction.html https://biospectrumindia.com/news/95/5077/we-will-reduce-the-cost-of-nucleic-acid-extraction.html Tue, 12 Apr 2011 16:22:00 +0530 Mr Hideji Tajima President, PSS Bio, Japan PSS Bio is one of the leading manufacturers of Automated Nucleic Acid Extraction systems and supplies themon an Original Equipment Manufacturer (OEM) basis to Qiagen, Rocheand Invitrogen. The company recentlyhad a technical collaboration with Mumbai-based Biotron Healthcare, for producing magnetic-based NucleicAcid Extraction kits. In an interview with BioSpectrum, Mr HidejiTajima, president of PSS Bio, Japan, talks about the collaboration and the ways in which it will reduce the cost of extraction, and also speaks about the company’s plans for India. Q Can you please throwlight on the technical collaboration with Biotron Healthcare for the magneticbased-Nucleic Acid Extractionkits? After successful technology transfer processes such as training, trial run and validation run, the NucleicAcid Extraction reagent production is started in March 2011. The facility will produce dedicated DNA/RNA extraction reagents for the automated instrument of 12GCPlus and all-round Nucleic Acid Extractionreagent for manual use. The production capacity is expandable based on the market need. It would be carried out in the clean rooms, installed at the Mumbai facility in India. Also, to ensure high quality, molecular labs with state-of-the-art equipment have been set up. Q How will these NucleicAcid Extraction systems reduce the costs of extraction?How different are these systems from other such extraction systems? The automated Nucleic Acid Extraction system can handle up to 12 samples within 40-90 minutes andcan function as a fully walk away system after setting the samples and reagents. This would take two-to-threehours if carried out in a conventional manual method. The 12GCPlus can show highly reproducible Nucleic Acid Extractionperformance that can contribute tost and ardization of the Nucleic Acid Extraction procedure. One of theadvantages of the 12GCPlus is that it uses magtration technology for separating, mixing and collecting the magnetic beads for extraction. Compared to other extraction procedures, the magtration system, which is a patented technology by PSS, can provide nucleic acids of better quality that have high purity (less contamination by other chemicals) and high yield. Q What market opportunities does India have tooffer as far as these automated extraction kits are concerned? Biotron can directly supply the reagents manufactured in Mumbai to Indian customers and can directly access customers’ responses. It is critical for Biotron to understand its customers’ need and incorporate their request for not only further enhancement of quality but also for considering new products in timely manner. But, at the same time, the runningcost of extractions on any automated platform is higher than the manual costs. The labs, especially in India, are thus unable to see the value in going for automation. Through this new arrangement we aim to bring down the costs of extraction on automated platforms, considerably, and hence increase the automation platforms in India in the life sciences segment and molecular diagnostics segment. Q Which are the exporting destinations for the kits produced at the new facility? Will the company venture into similar technical collaborations in the APAC region? The automated nucleic acid extraction method has just started in India and in South East Asian countries. However, the per-test-price of dedicated reagent for the instrument is an issue that is causing hindrance in the proliferation of the automation in the APAC region, similar to problemsin India. The reagents for Automated Extraction will pave the way for the kind of automation that will supersede the time consuming and labor intensive conventional nucleic acid extraction method. Q What are some of the issues PSS Japan faces in India? PSS has developed and manufactured small-to-large scale instruments for various needs of customers. We expect to hear a lot from our customers in India, regarding what they would like to have in their automation system. We could offer the instrument that will meet the Indian customer’s requirement. Q What are the plans for PSS Japan in India andhow will the company take its partnership with Biotron forward? The prevalance of various infectiousdiseases including HIV, HBV, HCV, along with cholera, malaria, denguefever, tuberculosis and tetanus is not restricted only to India, but is a problem that exists in many other Asian countries. To identify disease-causing germs rapidly and precisely, the need of genetic diagnostic technology is indispensable. However, as the genetic diagnostics require complicated skillful technique, it has not successfully spread even in the advanced nations such as the US, Europe and Japan. PSS is hoping to start the evaluation of fully-automated genetic diagnostics systems in India, a country where the importance of genetic diagnosticsis deeply recognized. In that context, PSS and Biotron are looking for partnerships with institutions like hospitals, blood banks and reference laboratories in India. Nayantara Som in Mumbai ]]> <![CDATA["We will launch our first biological product in India"]]> https://biospectrumindia.com/news/95/1390/we-will-launch-our-first-biological-product-in-india.html https://biospectrumindia.com/news/95/1390/we-will-launch-our-first-biological-product-in-india.html Tue, 12 Apr 2011 16:20:00 +0530 Dr Kamal K Sharma managing director, Lupin Lupin has made significant progress since it first rolled out its biotech program three years ago. In an exclusive interview with BioSpectrum, Dr Kamal K Sharma, managing director of Lupin, gives insights into the company’s business strategy in biosimilars and the new biological entities space. Q Can you elaborate on the progress of Lupin’s biotech program? What is your strategy for the future? Mr Sharma: Biotech remains an area of strategic focus and a key part of Lupin’s road-map for the future. We started our biotechnology program three years ago and we have made rapid progress since then. We have set up our dedicated research and manufacturing facilities in Pashan, Pune. Lupin’s strategy and its execution would be very global and in keeping with rigors as demanded by regulators the world over. We plan to make our presence felt in biosimilars, the same way we have emerged as a global generics powerhouse. As is evident from our past behavior, our approach would be dictated by how frameworks and regulatory pathways pan out in various key markets. At Lupin, we have always stressed on growing organically and we will continue to follow the same. However, that does not mean we would not look at other modes of growth, be it strategic alliances, partnerships or the inorganic route. All the initiatives will be in tune with our acquisition philosophy and should be in sync with our business road-map. Lupin is now looking forward to launch its first biological in the Indian market by the middle of this fiscal year and going forward, we would like this to contribute about five percent of our global revenue by 2015. Q Can you tell us more about the first biological drug from Lupin? Mr Sharma: The launch of our first biological drug in the Indian market is most likely to happen by the middle of this fiscal year. Lupin currently has seven proteins, all in different stages of development. They consist of both microbial as well as mammalian proteins, focusing on the areas of oncology and diabetes. Q What are the biotech facilities available at Lupin? Mr Sharma: We have state-of-the-art facilities dedicated to R&D in biotechnology outside Lupin Research Park (LRP) in Pune. The vision of the research group is to develop and commercialize biosimilars and new biological entities (NBE) for the company. This R&D facility has already been approved by the Institutional Bio Safety Committee (IBSC) for research on recombinant DNA. Furthermore, this facility has also been accredited as a biotech center by the Bioinformatic Center, University of Pune. Our biotech program has close to 100 personnel involved in research and support functions. We have invested a lot of resources for recruiting, nurturing and retaining talent in this regard. The team has unmatched domain expertise, and stellar academic qualifications. In fact, we have recently appointed Dr Cyrus Karkaria as the new head for our biotechnology efforts. He is the president of biotech division at Lupin and he comes with 15 years of experience in biotech research. Q Has Lupin entered into in-licensing deals for biologicals products in India? What will be the company’s development strategy towards these products? Mr Sharma: According to industry experts, the market share of India in the biosimilars space has so far been negligible. Lupin’s biotech endeavors have come a long way since they were initiated three years ago. To optimize production facilities for biotech drugs and considering the time required for developing own drugs, we had in-licensed a few products from overseas players. We have already in-licensed three products for the Indian market and we are now in the process of in-licensing two more products. Q Which are the overseas markets targeted by Lupin for biosimilars and how lucrative is the Indian market for the same? Mr Sharma: The US and EU markets will undoubtedly be the lucrative ones for Lupin in the future but we intend to start by pushing our biosimilar product line into the Indian market and then branching out to the emerging markets. However, our biggest growth will be on the US and EU market, where we are still working on building competencies given the regulatory rigors that are prevalent here. We, nonetheless, believe that these markets will offer tremendous potential, once they fully open up to biosimilars. Also, in the coming years, oncology, rheumatoid arthritis and diabetes will prove to be lucrative therapeutic segments for Indian biosimilar players, with the rise of these disease levels across the globe. For oncology, growth will be in areas such as colon and breast cancer in the light of the increasing rise of prescriptions in the US. The global market for biosimilars is worth $120 billion and emerging markets contribute 18 percent of it. The Indian biosimilars market is set to grow at 20 percent by 2015 at par with the global growth rate. In terms of revenues, the Indian biosimilars market is estimated to register $2 billion by 2015 which contribute to 10 percent of the emerging economies. This gives us tremendous scope and opportunities, as far as selling biosimilars in the Indian market is concerned. However, when compared to generic drugs, biosimilars are difficult to develop and the regulatory hurdles are more difficult to clear. Q How will Lupin Research Park augment the company’s overall growth in the biotech space? Mr Sharma: Lupin Research Park is the company’s global R&D hub. The company now has over 850 scientists as compared to 550 research scientists last fiscal. The increase in the past year has been on the drug discovery side, which we have recently revamped. Lupin’s R&D group in Pune supports all our markets working in conjunction with our subsidiaries, strategic business units and business groups, helping them identify lucrative opportunities and put in place a well-differentiated, value-based product pipeline. Lupin’s biosimilar-related R&D work takes place in our Lupin Bioresearch Center (LBC) in Pune which houses two clinics with a total of 56 beds, a bioanalytical lab with seven state-of-the-art LC/MS/MS systems and its own clinical chemistry lab amongst several other capabilities. LBC conducts important bioequivalence testing exclusively for Lupin’s generic products prior to the filing of abbreviated new drug applications or other regulated market filings. LBC also manages outsourced bioequivalence studies and clinical end-point studies. Nayantara Som in Mumbai ]]> <![CDATA["Biofuel reduces carbon emission"]]> https://biospectrumindia.com/news/95/2717/biofuel-reduces-carbon-emission.html https://biospectrumindia.com/news/95/2717/biofuel-reduces-carbon-emission.html Tue, 12 Apr 2011 16:18:00 +0530 Dr Ranjan Patnaik Head, Biofuels Research Group, DuPont Knowledge Center (DKC), Hyderabad DuPont, an American chemical company that was founded in 1802, has come a long way since its inception from being a gun powder company to being one of the fiercest advocates of providing carbon-neutral energy to the world. DuPont’s Knowledge Center in Hyderabad, which is spread across 15 acres and has received investments worth $29 million (130 crore), is home to DuPont-BP biobutanol advanced biofuels program.  Dr Ranjan Patnaik, head of Biofuels Research Group, DKC, Hyderabad, who was among the speakers present at EmTech India 2011 — an annual event conducted by Technology Review India — provided insights into the present scenario of biofuel consumption and R&D in India during the plenary discussion. Dr Patnaik in his interview to BioSpectrum also acknowledged the fact that although much research has been done in various laboratories across the world, only negligible proportion of this knowledge has actually got translated into reality. Q What do you think is the future of energy in our country? Dr Patnaik: The future of energy has to be diversified so that you do not invest everything in one form or source of energy. The power portfolio has to be properly balanced and it has to be adjusted to the geo-political situation in every country. Q We still have vast amounts of fossil fuels and we have an unlimited source of energy in the form of the sun. However, there is a lot of hue and cry over the scarcity of fossil fuels. What are your thoughts on this?  Dr Patnaik: The few major global trends that are happening around us are concerned with nutrition for the population and reducing dependence on fossil fuels. A lot of new technologies that have come into existence are slowly giving us the incentive to rethink — how we want to manage our energy portfolio. Although everything comes from sunlight but it is not going to fulfill all our energy needs.  The sunlight has to be trapped into a usable form. One of the usable forms is the liquid transportation fuel, including petrol and diesel, and the other is electricity. Q Which energy compounds is DuPont working on presently? Dr Patnaik: DuPont is working on biobutanol. Biobutanol was first used in World War II as a fuel and it was obtained by the process of fermentation of renewable feed stocks with bacteria. Biobutanol has many advantages as compared to ethanol. Biobutanol can also be directly used in the existing petrol or gasoline infrastructure. We use the technology of metabolic engineering and rewire the bacteria or yeast to make a pure product of biobutanol. We are also working with cellulosic ethanol, which is being obtained from non-edible agricultural residue (cellulosic biomass). Q What is your personal take on the energy crisis? Dr Patnaik: Although there is an ever increasing demand for energy, we should try to cut down on the usage and learn how to conserve. I believe that simple changes in one’s lifestyle and daily habits can help us reduce energy consumption drastically.   Q Burning of fuels, irrespective of the source they have been produced from, leads to carbon di-oxide (CO2) emissions. Is there any way in which we can control this? Dr Patnaik: Since, we value energy and we put a price tag on the kind of energy we access, an important factor that emerges is energy sustainability. Biofuel emerges as a clear winner in this context. If you analyze the life cycle of biofuels, from beginning of harvest to burning in the car, there is a net reduction in the carbon emission. We cannot expect this from fossil fuels. However, the present mixed energy portfolio has very negligible contribution from biofuels. Thus, what we are trying to do now is to balance the mixed portfolio in such a way that it accelerates towards a net zero scenario. Q What is your opinion on the ‘drop-in’ biofuels and their usage in our country?     Dr Patnaik: We have been using ethanol as a blended biofuel in the form of E85 or E10 and butanol is now being used as it is a far advanced biofuel as it has several other properties better than ethanol. Butanol can be blended with petrol or gasoline at a much higher level than ethanol and can be dropped-in directly in the engine. We are also working on other technologies that are still in the incubation stage. Q What are your major concerns associated with the future of biofuels? Dr Patnaik: A good source of fuel is the one which you can apply with ease. A biofuel will be considered to be a good fuel only if it is efficiently able to run the present engines. Since there is still an abundant availability of fossil fuels and as such the internal combustion engines are not going to disappear, biofuels that can support the present infrastructure and power distribution grids will emerge as the champions in the future. However, it will take time for any such source of biofuel emerge as a major fuel soruce. Saptarshi Chaudhuri in Bangalore ]]> <![CDATA[From Biosimilars to Similar Biologics]]> https://biospectrumindia.com/news/95/1973/from-biosimilars-to-similar-biologics.html https://biospectrumindia.com/news/95/1973/from-biosimilars-to-similar-biologics.html Tue, 12 Apr 2011 16:15:00 +0530 Just a decade ago, the contours of the Indian biotech industry began to emerge with the entry of dozens of promising start-ups. Companies in this segment have to be long term players due to the long gestation periods involved product discovery, development, regulatory approvals and marketing. Yet, within a decade many of these start-ups have taken tentative steps to remove the shackles of geography and look at the world itself as their playground. The boundaries of India need not limit their ambitions, was the refrain. The baby steps have turned into significant leaps for many of the biotech companies. The growing trend of the presence of Indian biotech industry, still very small in the global context, on foreign shores has been attracting some attention in recent months. Who are the players who have boldly ventured out of India in recent years? What is their motive? How do these companies views these foreign forays, both strategically and tactically? The Cover Story – 'India Biotech Goes Global' in this issue of BioSpectrum has tried to capture the essence the wanderlust of Indian biotech companies in a small way. We have featured nearly a dozen companies and this is the not exhaustive list of those who have found fame and fortune outside India. Many more active players like Jubilant Life Sciences, Bharat Biotech, Shantha Biotechniques, and many BioAgri companies too who are not part of the coverage in this issue, too have made significant strides. We hope to have a sequel to this report in the subsequent issues. One thing is clear from this trend. Biotech companies will not limit their footprint to just India and will look outward all the time for the right opportunities. For some like Biocon, the Malaysian foray is critical to come to speed on its expansion plans and the national government there has wooed the company with the best in class infrastructure it was looking for and was not available within India. But is it third time lucky for the ambitious Bangalore Helix project to build a big biotech park in Bangalore? Things are moving again related to the phase 2 of Bangalore’s biotech park, Bangalore Helix. The Karnataka government agency spearheading the project has received interest from five companies to handle the construction of the proposed 300,000 sq ft facility. Five years ago, the bidding process came to a standstill as only one company was left in the fray in the final stages. The second attempt two years during the economic downturn drew a blank. If the private sector in biotech is looking outward, can the government be far behind in trying to leave behind its biotech mark globally? Certainly, the Indian government is attempting to do this in an interesting way. The chosen way is the introduce a new terminology for biological products which resemble the original innovator products. The Review Committee on Genetic Manipulation in the Department of Biotechnology has proposed a new name, “similar biologics” to describe what is generally now known as biosimilars. In the conventional pharma industry, the products similar to the chemistry based drugs called generics. In biotech, these are called biogenerics or follow on biologics in the US, ‘subsequent entry biologics’ in Canada. India proposes to call these off-patented biotech drugs ‘similar biologics.’ With the rise of India in the global arena as an economic firehouse, I am sure, the Indian contribution of ‘similar biologics’ will soon become equally acceptable to the biotech ecosystem globally in a very short time. Narayanan Suresh Group Editor sureshn@cybermedia.co.in ]]> <![CDATA[India biotech goes global]]> https://biospectrumindia.com/news/95/1429/india-biotech-goes-global.html https://biospectrumindia.com/news/95/1429/india-biotech-goes-global.html Tue, 12 Apr 2011 16:08:00 +0530 A decade-old $3 billion Indian biotech industry, supplying over 50 percent of global vaccine requirement has been making its presence felt in the global biotech market through acquisitions and by establishing direct presence in other markets. The trend has picked up in the last five years mainly in the areas of clinical development services, bioinformatics space, drug discovery and market accessibility. Capabilities and market access are the key drivers for overseas investments of Indian biotech  companies. Says Mr Ajit Mahadevan, Partner, Ernst & Young, “The companies are acquiring firms and assets in the Western markets to get an access to the markets globally. The services industry is acquiring companies globally to acquire capabilities in drug discovery and clinical development services. India is still developing capabilities in early stage discovery and biologics. Moreover, a lot of the animal studies (large animal) are done outside India. This has led companies to look westward to acquire such capabilities and technology as they move up in the value chain. In addition, in the outsourcing business, proximity to the customer is the other key factor and has driven the acquisitions of the Indian companies. Since 2004, companies such as Biocon, Ocimum Biosolutions, Strand Life Sciences, Veeda Clinical Research, Synchron, Reliance Life Sciences, SIRO Clinpharm, Stempeutics, Hester Biosciences, Venkateshwara Hatcheries, Jubilant have announced global deals or have set up direct operations mainly in regions like Europe, the US, Middle East, and South-East Asia. Jubilant Life Sciences has picked up many companies in the US and Europe. Bharat Biotech has manufacturing facilities in Malaysia and markets its products in South  Kora. Shantha Biotech has got marketing approvals in Vietnam. On the business model adopted by the Indian biotech companies to be a success in overseas markets, Mr Ajit Mahadevan says, “The Indian companies are learning to integrate the acquisitions into their existing businesses.  They have increasingly begun to take a more involved and integrated approach as against the hands-off approach being followed earlier.” The opportunity, market accessibility, proximity to customers are providing ample space for the Indian biotech companies to go global with key interests in the US, Europe and South-East Asia. In the following pages BioSpectrum features some of the prominent companies that are riding the global wave. Veeda Clinical Research: The specialized Global CRO Mr Apurva Shah, Group MD, Veeda Clinical Research Stempeutics: Gets bionexus status in Malaysia Mr B N Manohar, CEO, Stempeutics SIRO Clinpharm: Bullish on Asia-Pacific Dr Chetan Tamhankar, CEO, SIRO Clinpharm Hester Biosciences: Betting Big on Animal Biologicals  Rajiv Gandhi, CEO & MD, Hester Biosciences Reliance Life Sciences: Cashing on Biosimilars Mr KV Subramaniam, President, Reliance Life Sciences Strand Life Sciences: Taking Indian bioIT to US Dr Vijay Chandru, Chairman & CEO, Strand Life Sciences Ocimum Biosolutions: On an acquisition spree Ms Anuradha Acharya, CEO, Ocimum BioSolutions Biocon: Spreads wings globally Dr Kiran Mazumdar Shaw, Chairman & MD, Biocon ]]> <![CDATA[On an acquisition spree]]> https://biospectrumindia.com/news/95/1537/on-an-acquisition-spree.html https://biospectrumindia.com/news/95/1537/on-an-acquisition-spree.html Tue, 12 Apr 2011 16:05:00 +0530 Ms Anuradha Acharya CEO, Ocimum BioSolutions With strong understanding of the market needs and requirements, Ocimum Biosolutions went on an acquisition spree to establish its base in the global market Ocimum Biosolutions, a leading integrated global genomics company providing GLP-compliant microarray services, comprehensive genomic reference databases, life science lab information management solutions and essential research consumables, began its operation first in the US in 2000 and a year later, set up office in India. Besides these two markets, during its journey in the last 10 years, the company has established direct presence in other markets such as Germany, The Netherlands, the UK and Japan and has presence in many other countries through partners. Ocimum Biosolutions, a life sciences R&D enabling company, with the main focus on three areas: bio-IT, micro-arrays and contract research services, had signed a letter of intent in 2005 to acquire MWG Biotech AG’s microarray business, which is the international provider of DNA sequencing and DNA/siRNA synthesis services for academic and industrial research with production sites in Germany, the US, and India. The acquisition was consistent with their strategy to become an integrated genomics company providing wet lab research tools, bioIT solutions and contract research services to the pharma and biotech industries. Global Expansion In order to become a global company, Ocimum later acquired biomolecules synthesis business of Isogen Life Science based in The Netherlands in 2006. This deal was a significant step towards becoming a global oligo player. This acquisition helped Ocimum become a more integrated genomics services provider with three delivery points in Indianapolis, IJsselstein and Hyderabad. Continuing its acquisition spree, Ocimum Biosolutions announced the acquisition of US-based Gene Logic’s genomic business for $10 million (44.7 crore) in 2007. With this acquisition, the company has done three global acquisitions in the span of three years, a deal per year. The purchase agreement includes the Maryland-headquartered, Gene Logic’s knowledge products business, which is anchored by the world’s largest databases of human biology. As part of the transaction, Ocimum also acquired Gene Logic’s comprehensive genomic and genetic services business that provides customers with access to a bio-repository of over 80,000 samples. Recalling the acquisition, Ms Anuradha Acharya CEO, Ocimum Biosolutions says, “The genomics business, when integrated with Ocimum’s strengths in bioIT, biomolecules and bioresearch groups, forms a premiere business that can support multiple aspects of the life sciences industry. Gene Logic’s genomics customers will also benefit from Ocimum’s global presence.” Currently, with a five-acre campus that has four large units of around 100,000 sq ft in each unit adding to around 400,000 sq ft of lab and office space in India; and with a 55000 sq ft state-of-the-art lab in the Gaithersburg area in Maryland (suburb of Washington DC), which is known as Gene Logic; Ocimum Biosolutions has already established a strong foothold in the global market. “We are a global company since we began our operations in 2000 in the US and 2001 in India. Since then we have been expanding globally both through acquisitions and by opening offices and presence through partners,” adds Ms Acharya. Suchitra Pillai in Bangalore ]]> <![CDATA[Cashing on Biosimilars]]> https://biospectrumindia.com/news/95/2001/cashing-on-biosimilars.html https://biospectrumindia.com/news/95/2001/cashing-on-biosimilars.html Tue, 12 Apr 2011 16:04:00 +0530 Mr KV Subramaniam President, Reliance Life Sciences Reliance Life Sciences has its eyes set on the lucrative biosimilars space and is all geared up to enter the emerging nations of the world Back in 2007, Mumbai-based Reliance Life Sciences (RLS) achieved the milestone of becoming the  first Indian biopharmaceutical company to make an overseas acquisition.  RLS’ acquisition of the UK-based biotech company, Genemedix plc was a win-win deal for both the sides. For the former, the acquisition was a gateway to the booming biopharmaceutical market in Europe and access to Genemedix’s wide product portfolio and its biopharma manufacturing facility based out of  Ireland, while for the latter, the acquisition bolstered its product pipeline.  Today, Reliance Genemedix plc plays a crucial role in RLS’ overall biosimilar strategy. The entity looks at the development and manufacturing of biosimilar products especially its lead EPO product, Epostim. This is but a slice of  the company’s two-fold global strategy – to have a direct presence in a market  or go through the route of partnerships and acquisitions, both in the regulated and semi-regulated regions of the world.  Nine years since it was first incorporated (in 2001), RLS has grown leaps and bounds. Apart from a strategic presence in Europe, RLS has expanded its wings, having representative offices in Singapore, Dubai, Sao Paolo, London and Houston.  Global Foothold Throwing light on the company’s game plan in the global landscape, Mr KV Subramaniam, president & CEO, RLS says, “We are currently pursuing a multi-pronged strategy for entering global markets for our products and services. This includes direct presence in the markets as well as entering into partnerships. RLS considers exports as an important part in its growth agenda over the next three-to-five years.” The emerging markets would be the key growth region for RLS’ global strategy over the next three years. In these markets, RLS is expecting multiple product approvals for select biopharma as well as pharma products. “These markets are growing at a faster pace compared to developed markets (like the US and EU),” adds Mr Subramanium. Biosimilars will be a major cash cow for the company in the coming years. The company has the largest pipeline of biosimilar products today. RLS already markets five biosimilar products in India.  The strategy is to first launch these products in the Indian market, followed by a launch in other countries. RLS is already looking at launching its biosimilar product for red blood production in Europe in a couple of months. While the EU region would be the main target out of the regulated markets, in the emerging nations, India and the semi-regulated markets would be the primary focus. Reliance Genemdix plc is focusing on developing and marketing biosimilars in European markets. Apart from biosimilars, RLS also develops and markets (both in India and overseas) five plasma protein products namely ReliSeal, AlbuRel, ImmunoRel HemoRel, ReliPlasma. Reliance Life Sciences also plans to foray into the global generic drug space under its entity Reliance Pharmaceutcials. It will produce active pharmaceuticals ingredients (APIs) and generic medicines for the international market including the US and Europe. Future Every international market presents a different set of challenges for any new entrant. For RLS, the key challenges were developing different product dossiers according to the regulatory requirement of each country and steering the approval process. However, having learnt the tricks of the trade and weathered the storm, the company is now geared  up to enter other markets of the world. In the coming years, Mr Subramaniam reveals, the company will look at entering the Russian and CIS regions. Nayantara Som in Mumbai ]]> <![CDATA[Bullish on Asia-Pacific]]> https://biospectrumindia.com/news/95/1108/bullish-on-asia-pacific.html https://biospectrumindia.com/news/95/1108/bullish-on-asia-pacific.html Tue, 12 Apr 2011 16:02:00 +0530 Dr Chetan Tamhankar CEO, SIRO Clinpharm Looking at the growing preference of global biotechnology and pharmaceutical companies towards the Asia-Pacific region for clinical trials, SIRO Clinpharm is leaving no stone unturned in order to tap into this high growth region One of India’s leading CRO, SIRO Clinpharm, had a global strategy to set foot in the European and Asian markets. Over the past 12 years, it has effectively followed the game plan. Both these markets made strategic sense to the company’s overall business model because of the large number of  pharma biotechnology and pharmaceutical companies situated in these regions. In addition, apart from targeting the traditional regulated markets like the US and the West-European markets, SIRO differentiated itself from the other Indian CROs by choosing to tap the unexplored regions of the East-European countries which offered the same advantages as India. Says Dr Chetan Tamhankar, CEO, SIRO Clinpharm, “In 2008, SIRO entered European clinical trials market through an acquisition of a mid-sized European CRO with a presence in several countries in Europe. At present, we have operational capabilities in 21 countries in Europe. In Asia, SIRO has operational capabilities in India.” Global Mantra Presently, SIRO’s strategy is to aggressively expand in both, Europe and Asia. Recently, it has  launched operations in Malaysia. Adds Dr Tamhankar, “We have operational presence in 10 more countries in Europe through alliances or freelancers.  The year 2011 will also see SIRO strengthening its field force presence in the US.”  SIRO has operational presence through its clinical monitors in India, Malaysia, Germany, France, United Kingdom, Poland, Russia, Greece, Spain, Romania, Czech Republic, Estonia and Lithuania. Currently, global biopharma companies are increasingly looking at conducting large multi-center, multi-geographic trials in order to quickly get their products in the global market. In such a scenario, SIRO is looking at leveraging its international footprint into these countries to effectively conduct trials. Moreover, these regions have a ready pool of highly skilled clinical research associates, data managers, biostatisticians, statistical programmers. But having a direct base there, SIRO will also have access to GCP-trained investigators. SIRO is bullish about the Asia-Pacific region. “We have seen that the number of clinical trials being conducted in Asia has skyrocketed in recent years. According to data (from clinicaltrials.gov) the number of clinical trials being conducted in Asia grew 67% between the years 2007-09. Also, many global biopharma companies rate India and China as top two destinations for outsourcing based on market potential and cost saving opportunities,” adds Dr Tamhankar. Future With the aim to serve clients better and to be close to the market, SIRO will be rolling out a phased expansion plan. The main focus of the expansion would be in countries of Asia-Pacific and Eastern Europe, while in the medium term the expansion plan includes North America. In addition, its  presence in Asia will be further augmented by the launch of operations in the Philippines and Thailand, later this year. Operational presence of the company in Europe will get a significant boost with a scheduled roll out in vital markets like the UK and Russia. SIRO will further penetrate into Europe by establishing operations in Czech Republic, Hungary, Italy, Poland, Romania and Spain. Aggressive expansion plan also includes forging new alliances in the Balkans, Scandinavia and Turkey. At the end of this expansion, SIRO will have an operational presence in over 30 countries. Nayantara Som in Mumbai ]]> <![CDATA[Gets bionexus status in Malaysia]]> https://biospectrumindia.com/news/95/7267/gets-bionexus-status-in-malaysia.html https://biospectrumindia.com/news/95/7267/gets-bionexus-status-in-malaysia.html Tue, 12 Apr 2011 15:59:00 +0530 Mr B N Manohar, CEO, Stempeutics Stempeutics, a stem cell company developing stem cell-based medicinal products, with facilities in Bangalore, Manipal and Kuala Lumpur, is in the process of bringing the first stem cell therapy product to the Indian, European and North American markets Bangalore-based Stempeutics Research, a group company of Manipal Education and Medical Group, opened the first-of-its-kind stem cell research facility in Malaysia, citing the ease in getting early approvals. Since its inception in 2008, Stempeutics has been working together with the leading medical institutions in Malaysia, to drive long-term research activities to further strengthen its leadership position in the area of stem cell research. Malaysian Presence As a result of collaborative efforts, Stempeutics Research announced in May 2010, that it has received clearance from Medical Research and Ethics Committee, Ministry of Health, Malaysia, for conducting human clinical trials in patients with ischemic cerebral stroke (CS), using investigational new drug (IND)-based on mesenchymal stem cells, derived from donated bone marrow. Stempeutics became the first international company in Malaysia to get the bionexus status from BiotechCorp. Also it has received National Pharmaceutical Control Bureau (NPCB) certification for its manufacturing facility for conforming to the requirement of current good manufacturing practices (cGMP), in accordance with the Pharmaceutical Inspection Co-operation Scheme (PIC/S) GMP guidelines and its relevant annexes for isolation, processing and storage of mesenchymal stem cells. Stempeutics is the first stem cell company in Malaysia to have obtained this conformance certification. Stempeutics has spent nearly 30 crore to set up a facility at Malaysia, with a strength of 20 members. “We are planning to invest another 20 crore in Malaysia to develop our first product from there. The phase II clinical trials for our product ‘Stempeucel’ have been successful. We aim to complete the phase III trial by 2013 and launch the product in the market by 2014,” says Mr B N Manohar, CEO, Stempeutics. “We have a very favorable environment in Malaysia where we get tax benefits up to 10 years from the date we start making profit. Along with that we have other customs duty incentives. With NPCB approval, we can go to nearly 20 other countries which come under the Organization of Islamic Conference (OIC), without any further clinical trials,” adds Mr B N Manohar while commenting on the presence in Malaysia. Global Challenges On the challenges while entering the global market, Mr Manohar says, “In the case of other countries, the main challenge is the regulatory procedures. Especially, since we are focusing on the stem cell market with no specific verified guidelines, we need to ensure that it is universally acceptable. With the source being of Indian origin, its acceptability abroad again poses as a challenge for us while we plan to venture abroad. The regulatory guidelines in clinical trials has to be followed.  Money too plays a major factor when you plan to enter the global market.” ]]> <![CDATA[The specialized Global CRO]]> https://biospectrumindia.com/news/95/1749/the-specialized-global-cro.html https://biospectrumindia.com/news/95/1749/the-specialized-global-cro.html Tue, 12 Apr 2011 15:55:00 +0530 Mr Apurva Shah, Group MD, Veeda Clinical Research Having made a spree of global acquisitions in the past five years, Ahmedabad-based, Veeda Clinical Research will now look at tapping the US market When Mr Apurva Shah and Mr Binoy Gardi co-founded Veeda Clinical Research in 2005, they had a focused strategy in mind – to establish a global presence instead of being India-centric. In addition to this, Mr Shah and Mr Gardi decided to specialize only in phase I early clinical development. Since then the founders have stuck to their guns. In a span of five years, it has been a journey of quick acquisitions of phase I CRO units across the globe for Veeda Clinical Research. The Global Call With stupendous growth of 70 percent driven by the strategy, Veeda  is known in industry circles as an ‘acquisitive company’. Today, it has a direct presence in the US, Europe, India and Malaysia. Within a span of five years, Veeda made four CRO acquisitions in Europe, has set up pharmacology units in India and the UK (Plymouth) and a biometrics team in Brussels, Belgium. In  January 2007, it completed the acquisition of DICE, a Brussels-based CRO unit. Subsequently, it forged a deal in May 2007, with Shanghai-based Novamed. In the same month it completed its acquisition of a phase I unit at  Gorlitz, Germany, thus adding to its existing European units in the UK and Belgium. The same year, it also announced  plans for another four acquisitions in four months, in addition to investing another 100 crore in expansion of facilities and acquisitions. Recalls Mr Apurva Shah, group managing director, Veeda Clinical Research, “We made our first acquisition of a top end phase specialist unit in the UK in June 2005, making us the first Indian CRO to go out and make an acquisition. We wanted to be a specialized high quality CRO instead of a general “can do everything” kind of Indian CRO.” From a company which had five people on board, the present  manpower strength has gone up to over 400 people across the globe. In terms of infrastructure set-up, the company has spread its wings far and wide. “We have 162 beds at Ahmedabad; six beds at a specialty hospital in Nadiad, India; 61 at Plymouth, UK and 40 beds at Malaysia. We have a staff of 30 people in the US for oncology studies and are about to purchase a Phase 1 unit at the US soon. We also have biometrics unit at Mumbai and Belgium,” adds Mr Shah. This apart, Veeda’s subsidiary unit, Veeda Oncology has been maintaining a good track record. Established in 2008, Veeda Oncology provides phase I-IV studies in the field of  oncology to pharma and biotech companies. In the same year, it announced that it had completed the acquisition of Biologie et Industrie (B&I), an oncology CRO founded in 1984, based in Paris, France. The division has operations in India, Eastern Europe, Western Europe and the US. In 2010, it was awarded new clinical research programs worth over $8.4 million. On the whole, the company has made consolidated investments of 100 crore till date. The Game Plan Forward The acquisition strategy has not been a cakewalk for the company. The challenges have been humungous in terms of finding the right partner who could be a strategic fit for Veeda. “To find the right organization and people, closely matching the value system of Veeda is very challenging. As this is a people-orientated business, distance plays a critical factor and a lot of time is required in each geographic location for integration.” Having consolidated its position in India, South East Asia and Europe, Veeda is now looking at the US market which it has not yet tapped. “We believe that the future of pharma lies in the East but the US economy will also bounce back soon, and thus a presence in the US is very much required. The advantage of being close to the client is to understand the business and the cultural needs of each region. China is a crucial market for  the future and we plan to be there in 24 months,” concludes Mr Shah. ]]> <![CDATA['We intend to invest Rs.40 crore in India R&D lab']]> https://biospectrumindia.com/news/95/6677/we-intend-to-invest-rs-40-crore-in-india-rd-lab.html https://biospectrumindia.com/news/95/6677/we-intend-to-invest-rs-40-crore-in-india-rd-lab.html Tue, 15 Mar 2011 12:31:00 +0530 — Mr Rajiv Gandhi, CEO & MD, Hester Biosciences, Gujarat Hester Biosciences Limited (HBL), an Ahmedabad-based company, has been in the business of manufacturing of poultry vaccines since 1997. The company has 39 licensed poultry vaccines and markets those products in India, Asia, Europe and Africa. HBL made its strong footing in Nepal last year by signing a joint venture agreement with Him Electronics Private Limited (HEPL), Nepal, to establish a first-of-its-kind animal vaccine manufacturing plant in Nepal. The proposed company – Hester Biosciences Nepal — will manufacture a range of poultry, sheep, cattle and swine vaccines for the Nepal as well as the global markets. The company believes that its presence in Nepal would open up new vistas and avenues of opportunities and simultaneously take HBL to the next level of growth. In an exclusive interview with BioSpectrum, Mr Rajiv Gandhi, CEO and managing director of HBL talks about the company’s strategy for Nepal, investments made for the animal manufacturing facilities and its future plans for the India market Q  How will the establishment of HBL’s operations in Nepal strengthen its animal vaccines business? Mr Gandhi: Hester Biosciences Nepal will be Nepal’s first biological unit. We got very good support from all levels, both from the Government of Nepal as well as from the business community. Nepal has good manpower resources in the field of biotechnology who are trained in different countries including India, the US and the UK. Also, culturally, Nepal is very similar to India. Climatic conditions are ideally suited for a biological plant. Nepal’s livestock sector is in a developing stage. Besides being assured of the local market, we intend to export certain large animal vaccines manufactured using the locally available strains. Q  What is the capacity of the proposed animal vaccine manufacturing facility and what are the terms of your JV with Him Electronics? Mr Gandhi: HBNPL is a joint venture between Hester and Him Electronics, which is part of the Golchha organization, a leading business house in Nepal. Hester Biosciences India holds 65 percent of the stake while Him Electronics holds 35 percent in HBNPL. We have a plan to start up with vaccines for swine, sheep, goat and a few poultry vaccines. We intend to do toll manufacturing for international companies. So, we are integrating most of our manufacturing capacity. Q  What has been the investment in terms of money, manpower and infrastructure for this new entity? Mr Gandhi: The estimated investment is $3.30 million (15 crore). The facility will generate 150 jobs for skilled and unskilled people. Animal vaccines based on in-house advanced capabilities will be manufactured in the areas of virus propagation in specific pathogen-free embryos, tissue culture and fermentation processes for bacterial vaccines. The facility will qualify for WHO-GMP certification, besides getting ISO, EMS, OHSAS accreditations. Q  When will production of these vaccines commence and to which countries will these vaccines be supplied ? Mr Gandhi: The commercial production of these vaccines is expected to commence from January 2013 onwards. Exports would be the focus area with 95 percent of the sales coming from exports. Target markets for animal vaccines produced from this facility are Asia, Europe, Africa and the US. Q  Are there any other projects in the pipeline for Hester Biosciences Nepal in terms of growth, revenues and expansion plans? Mr Gandhi: Besides addressing animal disease eradication programs implemented by the Government of Nepal, Hester Biosciences, as a company, will focus on planning strategies to find remedy for foot and mouth disease. Q  In the last one year, what were the new developments at Hester Biosciences in India? Mr Gandhi: Besides maintaining a consistent growth, Hester Biosciences is in the process of registering additional poultry vaccines as well as a few major animal vaccines in India. We are also working towards setting up an R&D wing to develop recombinant vaccines for poultry. We are also planning to expand our marketing presence globally. Q  What are the future plans for Hester in India, in terms of investments, products/ vaccines launches and business expansion? Mr Gandhi: In India, we intend to invest $9 million (40 crore) towards a modern QC/QA and R&D lab. We are also planning to venture into clinical trials for animal vaccines. Q  How do you view the animal vaccine market in India and what are its prospects? Mr Gandhi: The poultry business in India bounced back to its strong position after a year of recession. The foot and mouth disease vaccine market clocked $40 million [180 crore (300 million doses per annum)]; peste des petits ruminants (PPR) vaccine clocked $80 million [36 crore (180 million doses per annum)]; swine fever vaccine clocked $3.5 million [16 crore (13 million doses per annum)]; haemorrhagic septicaemia (HS) vaccine clocked $13 million [600 million (300 million doses per annum)]; goat pox vaccine clocked $5 million [24 crore (120 million doses per annum)]; and poultry vaccines market clocked $33 million (150 crore). The current growth rate could be taken at eight to 10 percent. The Government of India has already initiated foot and mouth disease eradication program and whereas, PPR and brucella eradication programs are under consideration, this is expected to boost the growth of animal vaccine industry. Nayantara Som in Mumbai ]]> <![CDATA['We are looking for long-term investments in India']]> https://biospectrumindia.com/news/95/5890/we-are-looking-for-long-term-investments-in-india.html https://biospectrumindia.com/news/95/5890/we-are-looking-for-long-term-investments-in-india.html Tue, 15 Mar 2011 12:28:00 +0530 The conventional naked eye approach of phenotyping is now getting replaced with the arrival of phenomics. It combines different technologies to study the various physical traits. — Mr Dirk Vandenhirtz, CEO LemnaTec, Germany A Germany-based company, LemnaTec, has a scanalyzer platform that generates digital images in a wide range of wavelengths far beyond human vision. The software auto-matically analyzes these images resulting in a considerable number of qualitative visual parameters. In an exclusive interview with BioSpectrum, Mr Dirk Vandenhirtz, CEO, LemnaTec, who was recently in India; shares his insights on the importance of phenomics, the company’s future plans and the Indian market scenario. Q  Tell us more about phenomics and the solutions offered by LemnaTec? Phenomics studies the physical and biochemical traits of organisms as they change in response to genetic mutation and environmental influences. It is used in functional genomics, pharmaceutical research and metabolic engineering. It helps us to visualize and analyze the biology beyond human vision. LemnaTec platform helps in identifying and numbering of traits that are important to researchers. Then accordingly, Marker Assisted Selection (MAS) can be used by the researchers. Our team of scientists develop hardware and software solutions for high-throughput and high content screening of plants, seedlings, insects and other organisms and for the automated evaluation of biotests in ecotoxicology. The idea is to bring the technology to the researchers. Digital images are primarily taken by the scanalyzer systems, PL, HTS, 3D, all set up in a modular design. Using advanced LemnaTec image processing algorithms, every visible sample parameter (e.g. color, shape, size, architecture) is subsequently measured and correlated with experimental records (e.g. genetic data). Besides, the small plant phenotyping, the high content and high throughput screening is used for basic research, pharmaceutical trials and plant protection. LemnaTec scanalyzer are able to automatically scan various plant sizes, ranging from trays with small Arabidopsis rosettes to crop plants of three meters. Q  How do you compare the market for phenomics in India with rest of the world? Every country has its own peculiar markets with a specific focus. In the US, the research is focused on soybean and corn, while Europe and India have different research areas depen-ding on local needs. So far, we have been supplying mostly to the US and the European markets. The Indian market is different and due to anti-GM policies, there is a slight reluctance among few companies to invest. However, notwithstanding that fact we are entering Indian, Chinese and Brazilian markets. Depending on the local needs, we are working with researchers to modify the platforms. Q  What kind of investments would LemnaTec make in India and what are your expectations from the Indian market? We have a long-term strategy for India as planning and implementation cannot be short-term. Primarily, we are building relationships with researchers. We selected Gurgaon-based Trishna Biotech as our partner to understand the local market and technology requirements. Trishna biotech offers consultancy and supplies the complete solution package to the Industry. In India, it will certainly take time, as these are high ticket instruments. Hopefully, we will have substantial investments in the next five years. In FY 2009-10, LemnaTec grossed $16.3 million (`73.78 crore) worldwide, and now in 2010-11, we expect it to grow upto $20.4 million (`92.34 crore). Our vision is to double the sales in phenomics business. Q  What kind of hiccups do you see in the implementation of your technology? The main challenges are high custom duty and dearth of trained people to handle this technology. Cooperation with the government in all countries is important as it is vital for the smooth transition of technology. The GM restrictions do pose a challenge but eventually we expect these to resolve. There have been initial hiccups but slowly we are overcoming them. What kind of association have you formed with the government agencies? It is really a challenge to feed the country’s huge population, especially in a country like India. Since weather conditions have colossal impact on the food production, we have identified projects with Indian Council for Agricultural Research on abiotic stress. Basically, we will be imparting training to the researchers working in the institutes about the technology. Having started with ICAR, the Department of Biotechnology and some CSIR institutes will also get involved. As of now, the National Agri-Food Biotechnology Institute of the DBT has a mandate to do research in the phenomics area. In the coming years, we are looking forward to work closely with the Indian government for the establishment of national phenomics centers across the country. Rahul Koul in New Delhi ]]> <![CDATA[Mission: Addressing space crunch with multi-deck shaker]]> https://biospectrumindia.com/news/95/1508/mission-addressing-space-crunch-with-multi-deck-shaker.html https://biospectrumindia.com/news/95/1508/mission-addressing-space-crunch-with-multi-deck-shaker.html Tue, 15 Mar 2011 12:24:00 +0530 With an objective to address the space issues in labs, Scigenics Biotech has designed a multi-deck shaker for researchers Given the fact that the space crunch has crept into almost all laboratories, using vertical space has become a necessity. Thinking on these lines, Chennai-based Scigenics Biotech came up with a project on the research, design and manufacturing of a multi-deck shaker. The idea is to provide the scientists with more area for cultivation within a small footprint. The project was initiated with the help of Small Business Innovation Research Initiative (SBIRI) funding under the aegis of the Department of Biotechnology (DBT), Government of India. With the optional features on CO2 and humidity maintenance, the equipment caters to a wide range of applications involving microbial, plant and animal cell culture. Dynamically balancing four shakers on one frame is an engineering challenge, since smooth running of the equipment is essential for arriving at high cell density in the flasks. Therefore, the success of such products straightaway contributes to the benefit of the scientific community and thus uplifts the Indian industry to global standards. Since its inception in early 1990s, Scigenics Biotech has been a pioneering entrepreneurial venture, in the manufacturing of bio-equipments under the brand name Orbitek. Headed by Mr S Gopal, managing director, and Ms S Neela, CEO and director, Scigenics focuses on manufacturing bio-equipments such as shakers, incubators, hybridization chambers, and plant growth chambers. Ms S Neela, CEO and director, Scigenics Biotech, says, â€œWe attended a review meeting for BSIRI funding in May 2007 and by November 2007, the loan amounting to 55 percent of the project cost was sanctioned to us. That was the highest cheque value we have received so far. We were very happy with the trust and confidence shown on us. We felt more responsible and became more ambitious. SBIRI through DBT has helped us in keeping pace with the technology.â€? Industry Impact According to the company, currently, there is no Indian manufacturer for multi-deck shaker with its specification. The developed product is expected to offer competitive pricing and reduced usage of floor space that will result in energy saving for customer. The response time, in terms of concept to product delivery, will be greatly reduced owing to high flexibility in parameter manipulations. Way Forward With the prototype testing and design validation in progress, the project is nearing completion and the commercial launch is expected in 2011. Because of the challenge from low price options, particularly from China and South Korea, Scigenics is upgrading to an extremely professional set up to take on global competition. Rahul Koul in New Delhi ]]> <![CDATA[Mission: Indigenous drug-eluting stent]]> https://biospectrumindia.com/news/95/2971/mission-indigenous-drug-eluting-stent.html https://biospectrumindia.com/news/95/2971/mission-indigenous-drug-eluting-stent.html Tue, 15 Mar 2011 12:21:00 +0530 The SBIRI funding boosted the efforts of Relisys Medical Devices to develop an improved version of drug-eluting stent that is helpful in preventing fibrosis Hyderabad-based Relisys Medical Devices has developed an advanced version of its drug-eluting stent (DES). The previous version was designed to eliminate the drawbacks of the currently available polymer-coated drug-eluting stent. DES is a coronary stent (a scaffold) placed into narrowed, diseased coronary arteries that slowly releases a drug to block cell proliferation. This prevents fibrosis that, together with clots (thrombus), could otherwise block the stented artery, a process called restenosis. The government funding from the Small Business Innovation Research Initiative (SBIRI) came as a boost to the research activities at Relisys. Prior to the fund allocation, stents were manufactured on contract basis in Europe and there was inconsistency in the quality. The company achieved a new milestone when its new cardiac stent manufacturing facility was inaugurated by the former President of India, Dr APJ Abdul Kalam, in 2007, in Hyderabad. This stent is indeed a highly-competitive product for a great societal mission. Equipped with an in-house laser processing facility, Relisys manufactures stents with consistent quality and better mechanical properties. This resulted in better coating quality and predictable drug release kinetics. With the better quality control equipments like SEM/ measurement microscopes, the ramp up time from R&D to pilot scale and pilot scale to production was minimized. This enabled the company to launch the base stents quickly in the market. Industry Impact The indigenous manufacturing of the product has provided better option for the patients. Relisys' new DES consists of a Cobalt-Chromium (CoCr) stent, coated with a porous carbon/carbon composite nano-structured matrix containing the active drug. DES sold under the brand name, COREL+C, is based on inorganic carbon coating where drug particles are homogeneously distributed inside the matrix. The coating is designed to maximum elasticity and its hardness exceeds stainless steel in terms of abrasion and scratch resistance, eliminating flaking, de-lamination or particle release. The advantages of DES are its low inflammation score, low fibrins score, 100 percent drug release, enhanced endothelialization, CoCr platform for better trackability and crossability and high radial strength. Way Forward With the success of this PPP initiative, an advanced DES is now available in the market at an affordable price. The company will price this product at around $1,200 (55,000), which is 50 percent lesser than the market price of DES. The overall reduction in foreign exchange outflow would be around $11 million (50 crore) during the life span of the product. So far, the bare metal stent that was used as the base for the DES has been commercialized. DES is expected to be commercialized by the end of 2011. Rahul Koul in New Delhi ]]> <![CDATA[Stem cell research needs regulatory pathway]]> https://biospectrumindia.com/news/95/2445/stem-cell-research-needs-regulatory-pathway.html https://biospectrumindia.com/news/95/2445/stem-cell-research-needs-regulatory-pathway.html Tue, 15 Mar 2011 12:17:00 +0530 A well-defined regulatory pathway and guidelines are needed to carry forward stem cell research and to bring out promising stem cell therapy Six-year-old Harshita, who was suffering from a genetic disease â€“ thalassemia major â€“ got a new lease of life following a successful stem cell transplant in New Delhi. Similarly, millions of people suffering from different diseases such as diabetes; cardiovascular disorders; neurological disorders; burns and wounds; osteoarthritis; osteoporosis; bone, cartilage and liver disorders; congenital abnormalities; and neoplasms, will get the benefits from stem cell therapies. India is one of the few countries in the world pursuing stem cell research. But regenerative medicine, comprising stem cell therapies and tissue engineered products, has a long way to go. Commenting on the prospects of stem cell therapy, Mr KV Subramaniam, president and CEO, Reliance Life Sciences, says, â€œIn India, about 164 million patients â€“ suffering from diabetes, cardiovascular disorders, neurological disorders, burns and wounds, osteoarthritis, osteoporosis, bone, cartilage (joints & replacements), liver disorders, congenital abnormalities and neoplasms â€“ will benefit from stem cell therapies by the end of 2011. Stem cell therapies are proved to be effective for ocular, cardiovascular, and neurological disorders. With growing interest of private companies in this domain and support from the government bodies, stem cell therapy holds great potential to emerge as the promising therapy.â€? â€œIndia shows more interest in stem cell research. Over 40 institutions, hospitals and companies are involved in stem cell research in the country. Till date, more than 90 programs have been implemented on various aspects of embryonic, iPS and adult stem cells. A few human embryonic stem cell (ESC) lines have been generated in some of the institutions and are deposited in UK Stem Cell Bank and National Center for Cell Science, Pune. These cell lines are being used by the national and international researchers for research purpose,â€? adds, Dr Alka Sharma, joint director, Department of Biotechnology, Government of India. Promoting stem cell research is one of her focus areas. Current Scenario According to reports, LV Prasad Eye Institute from Hyderabad has treated 600 corneal epithelium cases using stem cells, with 80 percent success rate. All India Institute of Medical Sciences (AIIMS), New Delhi; National Institute for Research in Reproductive Health (NIRRH), Mumbai; National Center for Cell Science, Pune; Center for Cellular and Molecular Biology, Hyderabad; National Center for Biological Sciences (NCBS), Bangalore; and Sankara Nethralaya, Chennai; are the other institutes which are working on stem cells. Most of these institutes focus on regeneration of damaged muscles as a result of heart attack, stroke or cornea damage. While companies like Reliance Life Sciences, Cryobanks International India, CordLife and LifeCell have created facilities to store stem cells from umbilical cord. â€œReliance Life Sciences has launched the first commercially available autologous limbal stem cell therapy, ReliNethra, for patients suffering from unilateral corneal blindness. Recently, we launched ReliHeal â€“ G (biopolymeric hydrogel wound management product) that promotes migration of new epidermal cells across the wound surface and is beneficial for early wound healing. We have also completed clinical trials using mesenchymal stem cells derived from the patient's bone marrow for myocardial infarction and we are carrying out clinical trials for application of stem cell-based therapies for stable vitiligo, non-healing diabetic ulcers, Parkinson's disease spinal cord injury and autologous stem cell conjuctival graft,â€? says Mr Subramaniam. Nichi-In Center for Regenerative Medicine (NCRM) is one of the few companies that is working on corneal epithelial stem cells. Apart from corneal stem cells, NCRM focuses on in vitro expansion of bone marrow and cord blood derived hematopoietic stem cells, which is expected to be a boon for leukemia patients. â€œWe mainly focus on degenerative diseases and have worked on osteoarthritis, spinal chord injury, for which trials have been done on eight patients and no side-effects were identified. In coordination with Dr KR Suresh, head of the department and consultant, Vascular Surgeon, Bhagwan Mahaveer Jain Hospital, Bangalore, we have started working on the treatment for critical limb vascular ischemia since 2005 and the phase I trials have been successfully completed and the study results were published in the Journal of Vascular Surgery in 2009. We are planning to extend the study to phase II. Nearly 70-80 patients with critical limb vascular ischemia have been treated so far and in last one year, we have treated 25 patients with osteoarthritis and 15 patients with chronic renal failure,â€? says Mr Gururaj Rao, research director, International Stemcell Services, Bangalore, which offers stem cell banking for regenerative medicine facilities including stem cell therapies, banking, expansion and differentiation. India Market Even though the stem cell research has emerged as a new branch of therapy with many institutes showing interest, it still remains a controversial topic amongst the public. And the main challenges faced are the lack of expertise, infrastructure, interdisciplinary network of researchers and clinicians for theme-based research, well-defined basic research leading to clinical/translational research and appropriate regulatory mechanisms. â€œThe issues related to ethics are focused on embryonic stem cells. No ethical issues were raised against iPS cells, but it might take another decade or two for iPS cells to reach the bedside. We have been working on adult stem cells, where the issues are mainly scientific rather than ethics. When the safety and efficacy are proved, it will become a routine therapy, as there is no issue related to misusing embryos,â€? says Mr Samuel JK Abraham, director, Nichi-In Center for Regenerative Medicine (NCRM), which carries out research, training and clinical applications-protocol development in regenerative medicine. â€œNo stem cells are universal that could address all the diseases. Bone marrow-derived stem cells may be good for few diseases but may not be good for others. Therefore, it is necessary to look and investigate new stem cells present in the human body that may be good and have certain therapeutics potential. But, the major hurdle faced is that there is no proven data that the stem cells are totally safe. Until we finish the clinical trial, it is not recommended to use stem cells for any diseases as therapy. People have little knowledge about scientific methods, overall process of science and their usefulness. Hence, the probability of people getting cheated are on high,â€? says Dr Satish Totey, president, Advanced Neuro-Science Allies (ANSA), which focuses on stem cell research and therapy primarily in neurological disorders and other diseases. â€œMany hospitals in India do not follow quality control since the stem cell injections are for parental use. Instead of creating controversy over stem cell therapy, regulatory bodies or committees should control very basic rule of Indian FDA that any injectable solution in India need certain facility and parameter and quality testing before injecting it in human or animal. Except bone marrow transplantation for cancer patient, no other therapies are yet proven and are a standard medical practice,â€? adds Dr Totey. The lack of awareness is one of the serious problems faced in stem cell research. With no proper trials or follow up the treatment is reaching the public. Many researchers and practitioners are aiming at the commercial aspect of it, thereby harming the human society. â€œIf proper awareness is given, people would encourage the new treatment. But, the only problem is that there is no regulation in this field. We have many doctors in New Delhi, who claim to treat many diseases using stem cell therapy and they charge $7,500-$8,500 (3.5-4 lakh) per injection. This is a grave issue which needs to be addressed. Even without proper approval by any regulatory body, practitioners are indulging in various treatments using stem cells, which is not at all safe. The rules are mainly followed to meet the pharmaceuticals requirements. Like pharmaceuticals, one cannot approve stem cells on the basis of dose-response ratio. Hence, the drug control rules are not applicable when it come to stem cell therapy,â€? says Mr Rao. Sharing his thoughts on the issues before the stem cell research community, Dr Totey says, â€œThere is no proper policy in this country and currently it is free for all kind of situation. Funding is very low and therefore the available funding cannot address all the potential ideas and good science. Funding is mainly alloted for low risk project, which is a barrier for innovation. R&D is not for public use. It is largely accessible to only select group of people. There are only a few clinical trials which get approval from Drug Controller General of India (DCGI). The central government should have clear mandate about their requirement rather than allocating funds for free. They should look for priorities and identify potential problem diseases in India. They should identify groups and expertise and give them a timeline to bring this product in the market for the needy patients. After which they can give these therapies to industry at a low cost so that the patients get benefited.â€? Considering the huge potential for stem cell market, many global players are eying India. â€œThe government authorities should provide fund for clinical trials instead of basic research. Encouraging basic research is needed but doing just basic research won't help. Practically, clinical trials should be encouraged to make the research more effective. If India does not move ahead with trials then foreign players will soon emerge ahead in the market,â€? says Mr Rao. With a lot of vulnerable factors attached to this therapy, the role of authorities and need for regulation is of much importance. A well-defined regulatory pathway and guidelines are needed to carry forward the stem cell research. Organizations working on stem cells Reliance Life Science, Mumbai Stemputics, Bangalore International Stemcell Services, Bangalore Advanced Neuro-Science Allies (ANSA), Bangalore Nichi-In Center for Regenerative Medicine (NCRM), Chennai All India Institute of Medical Sciences (AIIMS), New Delhi National Institute for Research in Reproductive Health (NIRRH), Mumbai National Center for Cell Science, Pune LV Prasad Eye Institute, Hyderabad Center for Cellular and Molecular Biology, Hyderabad National Center for Biological Sciences (NCBS), Bangalore Sankara Nethralaya, Chennai Bhagwan Mahaveer Jain Hospital (Jivas), Bangalore Indian Institute of Science (IISc), Bangalore National Brain Research Center (NBRC), Haryana Centre for DNA Fingerprinting and Diagnostics (CDFD), Hyderabad Nizam's Institute of Medical Sciences, Hyderabad Tata Institute of Fundamental Research (TIFR), Mumbai National Institute of Mental Health and Neuro Sciences (NIMHANS), Bangalore Post Graduate Institute of Medical Sciences (PGIMER), Chandigarh National Institute of Immunohaematology (IIH), Mumbai LifeCell, Chennai Pacific Stem Cells, Hyderabad Cryobanks International India, Gurgaon CordLife, Kolkata Even when controversies are on a high, the Department of Biotechnology (DBT), Government of India, has allocated $650,000 (3 crore) in the last five years towards basic and applied research in stem cell technology. The Indian Council of Medical Research and the DBT had already announced the guidelines for stem cell research and therapy in 2007, but India is yet to formulate norms for stem cell banking and storage procedures. The stem cell banking in India is yet to come under a regulatory framework. Moreover, Stem cell continues to be a promising field, which will rise to new levels in the coming years. Quotes: With growing interest of private companies and support from the government bodies, stem cell therapy holds great potential to emerge as the promising therapy. â€“ Mr KV Subramaniam, president and CEO, Reliance Life Sciences The issues related to ethics are focused on embryonic stem cells. No ethical issues were raised against iPS cells, but it might take another decade or two for iPS cells to reach the bedside. â€“ Mr Samuel JK Abraham, director, Nichi-In Center for Regenerative Medicine Clinical trials should be encouraged to make stem cell research more effective. If India does not move ahead with trials then foreign players will soon emerge ahead in the market. â€“ Dr S Gururaj A Rao, chairman & managing director, International Stem Cell Services 'Stem cell research is one of the thrust areas for DBT' - Dr Alka Sharma, joint director, Department of Biotechnology, Ministry of Science and Technology, Government of India Q Researchers have found new sources of stem cells such as corneal epithelium and bald scalps, what kind of support does DBT offers for such research? Stem cell research is one of the thrust areas of the Department of Biotechnology (DBT). It is supporting proposals on various aspects of stem cells including discovery of new sources of stem cells, and their applications in animal models. Support for proposals on stem cells from small and large biotech companies is also being considered and will get implemented through public-private partnership schemes such as Small Business Innovative Initiative (SIBRI) and Biotechnology Industry Partnership Program (BIPP). Q Last year, few meetings were organized by DBT to discuss the guidelines for stem cell research. What is the current status on these developments? Draft guidelines for stem cell research in the country have been formulated jointly by the DBT and the Indian Council of Medical Research (ICMR). These two agencies are working in close collaboration. Region-wise public consultations were organized at four places in 2010. The public consultation for the central region (northern region) is in the pipeline. The recommendations will be finalized and implementation report will be completed after the public consultation in the central zone. Q With many organizations targeting commercial profit from stem cell research/ therapy, what role can the government play as a regulator? The guidelines for stem cell research have been formulated and the same have been submitted to the Ministry of Health and Family Welfare for further processing as a legislation. Once it is converted into an Act with penalty clauses, it will help in regulating medical applications and curbing misuse. The DBT has constituted an independent â€œEthics Committee for Stem Cell Researchâ€? to consider the proposal from ethics point of view. Each proposal cleared by the respective Institutional Ethics Committee (IEC) is being considered by the DBT's Ethics Committee before processing. Our processes for funding are very stringent. The ICMR has similar credible arrangement. Q What are the measures taken by the DBT to step-up stem cell research in India? As with all areas of biology, the limiting factor for stem cell research is the inadequate number of scientists who specialize in stem cells. DBT has initiated fellowship schemes such as Wellcome Trust Fellowship and Ramalingaswamy Fellowship for increasing the talent pool in the country. The key components of our strategy are: Develop a skilled and brilliant pool of scientists in the area of stem cells Establish Center of Excellence in basic science institutes, medical institutes and selected animal institutes Operationalization of autonomous stem cell institute in Bangalore Organize world-class science meetings Send young people for overseas training Support public-private partnership research Establish global partnerships Suchithra Pillai in Bangalore ]]> <![CDATA[BMS strengthens hepatitis portfolio]]> https://biospectrumindia.com/news/95/2393/bms-strengthens-hepatitis-portfolio.html https://biospectrumindia.com/news/95/2393/bms-strengthens-hepatitis-portfolio.html Tue, 15 Mar 2011 12:12:00 +0530 BMS aims to improve on existing Interferon-based standard of carein conjunction with Peg Interferon and Ribavirin, and Interferon and/ or Ribavirin to minimize resistance of hepatitis C virus According to statistics, more than two billion people show evidence of hepatitis B virus (HBV) infection. About 350 million people have chronic HBV. Globally, 170 million people have chronic HCV infection and 20-30 percent of chronically infected will develop cirrhosis, one-third of which will progress to hepatocellular carcinoma (HCC). Hepatitis C virus (HCV) is the leading indication for liver transplantation in many parts of the world. Identifying the need to curb hepatitis, Bristol-Myers Squibb (BMS), the global biopharma company, has intensified its activities to find remedy for HBV and HCV, and restrict the spread of HCC. “Asia Pacific region is becoming the hotbed for HBV and HCV and that in-turn reflects an increase in the liver cancer cases. There is an urgent need to manage and restrict liver cancer by following an integrated approach,” says Mr Andreas Pangerl, global medical lead – hepatitis, Bristol-Myers Squibb. Hepatitis B Untreated hepatitis B is responsible for one million deaths worldwide each year. Giving insights on the initiatives taken by BMS to restrict HBV, Mr Paul Slade, executive director – virology, Bristol-Myers Squibb, says, “Hundreds of millions of people in the Asia Pacific region are at risk of developing severe liver disease, it is high time to find a promising remedy for this. The main challenge in tackling chronic hepatitis B is to find a complete cure. BMS’ Baraclude is a leading treatment regimen for chronic hepatitis B patients. Over 430,000 patients were treated in the past five years worldwide.” Baraclude (entecavir) was discovered by BMS as part of a large screening program to identify antiviral treatments. Baraclude was originally being investigated as a potential compound to treat the herpes viruses. It soon emerged that Baraclude had properties that made it a valuable drug candidate to treat the hepatitis B virus, demonstrating potent antiviral activity and high selectivity. Bristol-Myers Squibb embarked on more than eight years of clinical research, which ultimately demonstrated that Baraclude has been identified as a potent, oral antiviral therapy that can effectively reduce viral load to undetectable levels (<300 copies/mL) in the majority of patients chronically infected with hepatitis B. Baraclude has been approved for adults with chronic hepatitis B in several Asia Pacific countries including China and India (2005); Japan, Korea and Taiwan (2006); and Hong Kong (2007). Hepatitis C “The combination of PEG Interferon and Ribavirin is the current treatment option for HCV. About 50-80 percent of patients can be cured depending on the viral genotype, but there are associated adverse events including depression, fatigue, flu-like symptoms, and anemia. Duration of therapy for most HCV genotypes is 48-week with PEG Interferon and Ribavirin. The HCV strategy at BMS is three-pronged with the aim of improving treatment options across all genotypes, enhancing Interferon therapy (IFN-alpha) +/- small molecule antivirals, developing combinations of oral antivirals, +/– IFN and/or Ribavirin. Another compound, Brivanib is under broad-spectrum phase III development plan for Brivanibin unresectable HCC,” adds Mr Slade. "In India, more than 30 million people are infected with HBV and 19 million with HCV. In 2011, the government of India has made HBV a priority disease area. All children born in India will now receive HBV vaccine" — Ms Phangisile Mtshali Manciya, director – Delivering Hope, Bristol-Myers Squibb Foundation The phase II study of BMS investigational compound for HCV — Pegylated Interferon Lambda (PegIFN Lambda) — showed safety, viral response, and impact of host genotype. Based on current data, PegIFN Lambda shows promise across a broad range of doses and viral genotypes. Study is ongoing; and the results are expected by the end of 2011. BMS’ HCV DAAs NS5A Replication Complex Inhibitor (BMS-790052) and NS3 Protease Inhibitor (BMS-650032) are in phase II. BMS aims to improve on existing Interferon-based standard of care in conjunction with Peg Interferon and Ribavirin, and Interferon and or Ribavirin to minimize resistance of HCV. Broad-spectrum phase III development plan of BMS is ongoing for another inhibitor — Brivanib — in HCC. Brivanib Biomarker Program is exploring potential biomarkers that may predict efficacy and safety. Delivering hope Delivering Hope is an initiative of BMS Foundation, an independent philanthropic wing of BMS, to prevent hepatitis in Asia. The foundation is taking several initiatives in China and India. Ms Phangisile Mtshali Manciya, director – Delivering Hope, Bristol-Myers Squibb Foundation, said, “The foundation targets funding and takes initiatives to improve health outcomes at the community level; takes care of community mobilization and supportive services; and provides trainings to healthcare workers. The Foundation has awarded four new grants in China and India totaling nearly $1 million.” "Asia Pacific region is becoming the hotbed for HBV and HCV. There is an urgent need to manage and restrict liver cancer by following an integrated approach" — Mr Andreas Pangerl, global medical lead – hepatitis, Bristol-Myers Squibb Commenting on the initiatives taken in China and India, Ms Manciya, says, “In China, approximately 40 million people are infected with HCV. Testing for hepatitis is not accessible to more than 50 percent of the population. The Chinese government has declared HCV an urgent public health issue and named it as one of China’s top five deadly epidemics. Delivering Hope has made great strides in China since 2002, by policy outreach and contributing to the development of HCV operational research across the country.” “In India, more than 30 million people are infected with HBV and 19 million with HCV. In 2011, the government of India has made HBV a priority disease area. All children born in India will now receive HBV vaccine. The initiatives taken by Delivering Hope in India include the Hepatitis Foundation of Tripura (HFT) Vaccination Program; the Health Oriented Programs Education (HOPE) initiative for generating awareness of HBV in school children; development of a curriculum that can be adapted by local teachers across the school system in Uttar Pradesh; and to address the high hepatitis infection rates in the area, the United Way of Mumbai, together with Delivering Hope have developed a comprehensive targeted hepatitis education program,” she concludes. With Asia Pacific region gaining prominence because of the high prevalence of hepatic disease, BMS’ positive trial outcomes and other preventional initiatives raise confidence. Pradeep Kumar in Bangkok The author was in Bangkok at the invitation of Bristol-Myers Squibb ]]> <![CDATA['India is a perfect place for clinical research']]> https://biospectrumindia.com/news/95/6593/india-is-a-perfect-place-for-clinical-research.html https://biospectrumindia.com/news/95/6593/india-is-a-perfect-place-for-clinical-research.html Tue, 15 Mar 2011 12:10:00 +0530 â€œSince the global pharma companies have been outsourcing their clinical trials on a large scale, the CRO market will grow exponentiallyâ€? Dr Joshua Baker, CEO, CliniRx Research CliniRx, a full-service global clinical research organization conducts multi-national clinical trials with operations in the US, Europe and India. The company has a good network of alliance partners across Europe and Russia. In an interview with BioSpectrum, Dr Joshua Baker, CEO, CliniRx Research, shares insights on Indian CRO market and its challenges, and his company's future plans. Q What according to you are the business prospect of Indian market? Dr Baker: I have a great connection with India and I'm associated with the CRO business for quite a long time. As I have assessed the CRO business right from the 1990s, I can say that India has a great future in the CRO sector. The main purpose of this visit, is to develop business strategies and to develop good relationships with pharma and biotech companies and to ensure that the clinical trials are running smoothly. Since there is a great potential in the India market, I have come to participate in its growth. About 40 percent of our CRO business is outsourced whereas 60 percent of the business is retained in India. For CliniRX, approximately $150-175 million in revenues comes as services fees. Q What kind of partnerships do you have in India? Dr Baker: We have many partnerships in India on a contractual basis. Now, our main aim is to build substantial relationships with big pharma companies and their subsidiaries. We have plans to develop long-term relationships with these big companies. However, due to confidentiality agreement, we cannot reveal the names of these companies. Q Do you find the infrastructure in India adequate for CRO business? Dr Baker: India is a perfect place for clinical research. From availability of sites to patients, it has all the required infrastructure. Now the situation in India resembles that of the US in 1990s when the CRO business was growing exponentially. Q What kind of clinical trials are currently going on at CliniRx? Dr Baker: We have substantial experience in conducting clinical studies in several therapeutic areas. Clinical trials are happening in the areas of schizophrenia, oncology and cardiovascular. Besides, trials for various metabolic diseases are in the pipeline. Q What are your growth expectations in the coming years? Dr Baker: Since the global pharma companies have been outsourcing their clinical trials on a large scale, the CRO market will grow exponentially. We are looking forward to a significant regional expansion. I believe that CliniRx will grow significantly in the coming years. Rahul Koul in New Delhi ]]> <![CDATA[Max Neeman posts strong growth]]> https://biospectrumindia.com/news/95/2683/max-neeman-posts-strong-growth.html https://biospectrumindia.com/news/95/2683/max-neeman-posts-strong-growth.html Tue, 15 Mar 2011 12:08:00 +0530 Max Neeman International, a leading contract research organization (CRO) in India, has quadrupled the amount of clinical trials awarded since 2007 and reached the milestone of over 200 in 2010. Dr Ajoy Kumar, CEO, Max Neeman, said, “Focused areas of specialty, unique offerings, customer service and consistent growth in response to customer demand, are the cumulative factors which helped us to achieve this number.” This milestone depicts Max Neeman’s strong growth in three years and testifies the company’s philosophy and work ethics. The company boasts a 98 percent patient retention rate and has met target enrollments by the deadline while facing challenges of conducting studies involving tough protocols, gigantic enrollment targets and stringent regulatory requirements. Over 200 trials enhance Max Neeman’s experience in dealing with various therapeutic segments and unexplored areas of nutraceuticals, biosimilars and medical devices. In response to increased client demand over the decade, Max Neeman expanded its medical writing, data management, central lab and pharmacy services as well. Max Neeman has also brought together US and India-based renowned group of neuro and spinal surgeons from prestigious hospitals to form an advisory committee. The committee develops strategies for clinical research across newer therapies for central nervous system disorders. Regulatory challenges and technical issues along with associated strategies of conducting the clinical trials of newer therapies in India were planned. BenchBio, Genoscreen tie up for research In a major development in the field of crop genomics research, the Vapi (Gujarat)-based plant biotechnology company, BenchBio, has entered into an agreement with Genoscreen of France. The companies would share their resources to explore more in the field. BenchBio is an Indian biotechnology company that offers R&D projects and contract research services in the area of genomics, transcriptomics, high throughput marker development, bioinformatics and genome sequencing in crops. While the France-based company Genoscreen’s next generation sequencing technology is expected to give lots of scope in this field. Mr Manash Chatterjee, founder and director, BenchBio, said, “This collaboration will allow both companies to develop innovative technologies to provide solutions to the problems faced by seed companies.” The company mainly works on functional genomics using an organisms own genome and creates novel traits in crops without genetic modification. The collaboration combines the strong genomics research expertise of Genoscreen with the crop research experience and knowledge of BenchBio. The agreement is expected to focus more on India widely enabling the development of significantly improved crops for farmers worldwide. QPS acquires majority stake in Indian CRO US-based contract research organization, QPS, has acquired a majority stake in Bioserve Clinical Research. Bioserve, a full-service phase I CRO headquartered in Hyderabad, India, will be known as QPS-Bioserve India. QPS is a global CRO supporting drug discovery and development since 1995. Its five areas of expertise include preclinical DMPK/toxicology, bioanalytical, translational medicine, early-stage and late stage clinical research. Bioserve is an ISO 9001:2008 certified organization providing world-class clinical research services to sponsors across the globe. Its infrastructure includes a 92-bed clinical unit for conducting phase I studies and a bioanalytical lab equipped with multiple LC/MS/MS systems for small molecule bioanalysis. Over the past six years, it has conducted over 500 studies, with numerous product approvals, and has been inspected by the US Food and Drug Administration, UK Medicines and Healthcare products Regulatory Agency, World Health Organization and Drug Controller General of India. The company has been growing at a rate of over 50 percent per year, with a current team of over 100 employees. Clients include large Indian as well as multinational pharmaceutical firms. Bioserve’s promoters – the founders of Vijaya Diagnostic Center, one of the largest diagnostic healthcare companies in India – brings a wealth of 30 years experience in the healthcare and clinical domain, combined with a passion for quality. ]]> <![CDATA[ICMR starts study on diabetes]]> https://biospectrumindia.com/news/95/1977/icmr-starts-study-on-diabetes.html https://biospectrumindia.com/news/95/1977/icmr-starts-study-on-diabetes.html Tue, 15 Mar 2011 12:05:00 +0530 The Indian Council for Medical Research (ICMR) initiated its Task Force Project on diabetes in September 2006 with centers at different parts of the country during phase I. The regulatory body has now proposed to expand the study by including more centers throughout India. The primary objective of the project is to understand the disease pattern or types including the geographic variation and incidence and prevalence rate of complications. The secondary objectives are to facilitate research in the areas of basic, clinical (including patterns of care and survival), epidemiological, genetic and molecular levels; promoting awareness about the magnitude of problem among professionals, public health partners; assist in the development of management guidelines; and develop human resources in diabetes epidemiology. While intending to expand the study during phase II, in which more centers would be recruited, the council invited the applications for participation from clinical researcher/scientist from any medical colleges, government hospitals, institutes and clinics. The existing collaborating centers would provide training to new centers, intensify research activities at their respective centers and facilitate collaboration with state health services. The Intellectual Property Right for data being collected under the study rests with ICMR. The advisory committee set up by the council would review the merits of proposals. Remedy for traumatic brain injury Phylogica, an Australian drug discovery company, has successfully demonstrated preclinical proof of concept with a Phylomer peptide drug candidate for the treatment of traumatic brain injury. Using an internationally-established preclinical model, a three-year collaborative study with the Australian Neuromuscular Research Institute and the University of Tasmania has shown the compound, known as PYCAG5, is able to protect neural tissue at lesion sites and significantly reduce inflammation. The peptide was identified using Phylogica’s proprietary Phylomer drug discovery platform and the study was funded by the Neurotrauma Research Program (NRP) of the Western Australia Institute of Medical Research. Dr Paul Watt, CEO of Phylogica, said, “While several Phylomer peptides showed neuroprotective activity in this brain trauma model, PYCAG5 showed outcomes most consistent with therapeutic potential. This Phylomer significantly protected neural issue in the vicinity of the lesion at four days after the induced head injury and decreased the extent of inflammation, increasing the potential for healing at seven days post injury.” Dr Watt indicated that the average loss of neurons from the injured region treated with Phylomer PYCAG5 was less than one-third of the average loss observed for mock-treated control animals, or animals treated with a non-Phylomer peptide. Hilleman Labs initiates rotavirus vaccine trial The MSD Wellcome Trust Hilleman Laboratories, established in India with the mission of developing high-impact, affordable vaccines for people in developing countries in an innovative and sustainable way, announced that the organization’s first project will be a feasibility study into how new technologies might be used to develop a rotavirus vaccine designed specifically with developing country’s needs in mind. Formulations based on dissolving thin strips or granules will be examined for their potential to improve product stability, ease of use, transportation and affordability. The therapeutic focus of the project has been selected because of the tremendous global impact of rotavirus diarrhea on childhood mortality. If the initial study is successful, options to further develop the technology for rotavirus and other oral vaccines of importance to a developing country health will be explored. The project is a collaboration among the Hilleman Laboratories, MSD and Medicine in Need (MEND), an international non-profit organization specializing in the application of advanced vaccine formulation technologies. For this feasibility study, MEND is providing the formulation technology and MSD is providing components of its existing rotavirus vaccine. The World Health Organization estimates that every year 10- 50 percent of vaccines may be wasted globally because of temperature control, shipping, and other logistical issues. ]]> <![CDATA[FBAE urges govt to lift the ban on Bt brinjal]]> https://biospectrumindia.com/news/95/2841/fbae-urges-govt-to-lift-the-ban-on-bt-brinjal.html https://biospectrumindia.com/news/95/2841/fbae-urges-govt-to-lift-the-ban-on-bt-brinjal.html Tue, 15 Mar 2011 12:03:00 +0530 On the eve of the first anniversary of the moratorium on Bt Brinjal in India, the Foundation for Biotechnology Awareness and Education (FBAE), a non-profit organization formed to promote public awareness of scientific issues of biotechnology and to enhance levels of biotechnology education and training based in Bangalore has called for an immediate lift on the moratorium on the commercial release of Bt brinjal. Reiterating the concerns raised by over 40 Indian scientists at a workshop organized by the FBAE in July 2010 in New Delhi, and the memorandum submitted to the central government then, the FBAE cited recent important publications on the socio-economic benefits such as better living standards, health and education, and reduced tension, among the farming community and a healthier product to the consumer, that would accrue from the adoption of Bt brinjal. Scientists opined that the moratorium on Bt brinjal was strongly influenced by those opposed to agricultural biotechnology. They also suggested that like the Philippines, India should also follow the credible, critical, and balanced scientific judgment of technologists and biosecurity experts for the approval of genetically modified crops such as Bt brinjal. â€œThe government's decision of imposing a moratorium on Bt brinjal seriously affected research and development activities in the country's agricultural biotechnology sector. The moratorium has created a regulatory uncertainty on the development of all genetically engineered crops in the country. In a year, there has been no palpable, effective and time bound effort to lift the moratorium or to resolve the uncertainties caused by the moratorium,â€? said Prof C Kameswara Rao, executive secretary, Foundation for Biotechnology Awareness and Education (FBAE). Dr TM Majunath, consultant - agricultural biotechnology, said, â€œConsidering that the product efficacy, biosafety and environmental safety of Bt brinjal was evaluated for over seven years, as per international standards, involving over 200 scientists and more than a dozen public and private sector research institutions, Bt brinjal should be commercially released without further delay.â€? As per a recent publication from the National Center for Agricultural Economics and Policy Research, an ICAR institute, Bt brinjal adoption would add between 30,000 to 119,000 tons to the total production of brinjal, depending upon the extent of cultivation in different areas/ states. The absolute annual gain at the country level from Bt brinjal cultivation would be about $127.05 million (577 crore) at an adoption level of 15 percent, about $257 million at 30 percent and $526 million at 60 percent adoption levels. Natco challenges Gilead's Tamiflu patent Gilead Sciences, a biopharmaceutical company headquartered in California with operations in North America, Europe and Australia, has announced receipt of a Paragraph IV Certification Notice Letter advising that Natco Pharma, an Indian enterprise, submitted an Abbreviated New Drug Application (ANDA) to the US Food and Drug Administration (FDA) requesting permission to manufacture and market a generic version of Tamiflu (oseltamivir phosphate) 75 mg capsules. In the notice letter, Natco alleges that a patent associated with Tamiflu â€“ US Patent Number 5,763,483 â€“ owned by Gilead Sciences is invalid, unenforceable and/or will not be infringed by Natco's manufacture, use or sale of the product described in its ANDA submission. Gilead is currently reviewing the Notice Letter and has 45 days from the date of receipt to commence a patent infringement lawsuit against Natco. Such a lawsuit would restrict the FDA from approving Tamiflu's ANDA for up to 30 months or until a district court decision that is adverse to Gilead, whichever occurs first. Tamiflu is protected by this patent, which is listed in the FDA's Approved Drug Products List, and the patent would need to be invalidated or not infringed upon before a generic version of Tamiflu could be marketed without liability for patent infringement. Tamiflu was invented by Gilead Sciences and licensed to F. Hoffmann-La Roche in 1996. Tamil Nadu to announce new biotech policy In a major step to boost the biotech industry in Tamil Nadu, the state government is revising its decade-old biotech policy and coming up with new measures, investments and expansion plans. Mr MK Stalin, deputy chief minister, Government of Tamil Nadu, announced that the state government is formulating a new biotech policy with innovative features. Speaking at the inauguration of a roundtable on biotechnology development and its enabled services, organized by the industry association, CII in Chennai, he said that the state has plans to set up marine and medicinal plant biotech parks soon. Around 300 acres were identified to set up a marine biotechnology park, plans are also there to set up a marine biotechnology park and a medicinal plant biotech park. With the success of TICEL Biotechnology Park-I, which was established with the technical collaboration of Cornell University, US at a cost of $12 million (54.76 crore) and now fully occupied, the government is taking initiatives to drive the growth further. TICEL Biotechnology Park- II is expected to provide employment opportunities for 1,500 scientists. The park is expected to be completed in 2011 and will have a 'biotechnology core facility' to provide scientific and incubation support to the clients and biotech industries at the cost of $4.3 million (19.30 crore), and labs of BSL3 at a cost of $2million (7.37 crore). Mr Stalin also stressed on the need to ensure that any development made in biotechnology does not erode the genetic pool and the rich diversity in flora and fauna. According to Mr PM Murali, convenor, Confederation of Indian Industry (CII) Tamil Nadu Biotechnology Panel; Tamil Nadu has fallen behind other states such as Maharashtra, Karnataka, Andhra Pradesh, National Capital Region (NCR) and Gujarat, in spite of having several advantages in biotechnology. He proposed the need to form a separate department of biotechnology to enable 'single window clearance', which may attract a lot of MNCs in this field. Mr Murali also added that the Indian biotech industry was worth $3 billion (14,000 crore) last year according to the BioSpectrum ABLE Survey, and it will expand five-fold by 2015. Biogenerics worth $70 billion will come off-patent soon and it presents a great opportunity for Indian companies. It will also generate a lot of employment. The conference discussed about the need for a new policy which is expected to address the needs of the industry like creating infrastructure, bio-incubator facilities, regulations, human resources and a common platform for the industry, academia and the government to communicate, according to a senior official from the government. It would also elaborate on the funding options and policies to support biotech research and manufacturing. DHR frames health research policy The Department of Health Research (DHR), Ministry of Health & Family Welfare, Government of India, has sought the public opinion on its National Health Research Policy survey report. One of the mandates of the DHR is to improve governance of health research. DHR has asked for feedbacks to improve the quality and contents of this draft policy. As a first step, a National Health Research Policy was formulated with active participation and contributions made by several experts. The division of non-communicable diseases (NCDs) at Indian Council of Medical Research (ICMR) was identified as the nodal point for surveillance of NCDs and their risk factors by the WHO, and multi-site studies helped in developing a sound strategy for NCD risk factor surveys at the national level under Integrated Disease Surveillance Project (IDSP).The ICMR signed a memorandum of understanding with IDSP for the standardization and quality assurance of the NCD risk factor surveys under the World Bank-funded IDSP on behalf of Ministry of Health. As per IDSP plan, these surveys were to be carried out in three phases so as to cover all states and union territories in India. In phase I, the state-based estimates of the risk factors in seven states were arrived at through the IDSP-identified seven State Survey Agencies, five Regional Research Centers and a National Nodal Agency under the overall guidance and supervision of ICMR headquarters through the National Technical Advisory Committee. ]]> <![CDATA[China, Iran step-up presence at Bio Asia]]> https://biospectrumindia.com/news/95/2542/china-iran-step-up-presence-at-bio-asia.html https://biospectrumindia.com/news/95/2542/china-iran-step-up-presence-at-bio-asia.html Tue, 15 Mar 2011 11:59:00 +0530 The eighth edition of Bio Asia conference recorded the highest number of participation from 38 countries for the first time with India getting a major share of focus Dr J Geeta Reddy, Minister for Major Industries, Sugar, Commerce and Export Promotion of Andhra Pradesh presenting the Genome Valley Excellence Award to Dr Anji Reddy, chairman, Dr Reddy's Laboratories; while (L-R) Dr Roger Williams, CEO, USP; Dr Jun Yu, associate director, Beijing Institute of Genomics; Dr Abbas S Lofti, director general, NIGEB, Republic of Iran; and Prof Seyed E Hasnaian, chairman, AP Biotech Advisory Council, look on. Bio Asia 2011 was inaugurated by Dr Geetha Reddy, Minister for Major Industries, Sugar, Commerce and Export Promotion, Andhra Pradesh. The minister also launched four main projects such as Lonza R&D and manufacturing facilities; Sri Bio Integrated Discovery Center, a unit for stem cell banking and research from Pacific Hospitals; Tran-Scell Biologics; and Lepakshi Knowledge Hub. About 400 business meetings were organized as part of the event and over 1,500 people visited the exhibition center. This year, the Genome Valley Excellence Awards were presented to Dr Anji Reddy, chairman, Dr Reddy's Laboratories, for his contribution to the life sciences industry; and the Beijing Institute of Genomics, Chinese Academy of Sciences, China, for its exemplary work and contributions in the field of genomics. For the first time, 20 delegates from Iran and equal number of delegates from China participated in the event. After the release of the white paper, 'The Asian Promise', prepared by Grant Thornton, the knowledge partner of the event, country presentations were made by delegates from all across Asia. Commenting on the growth of biotechnology sector in Asia, Mr Mahadeven Narayanamoni, partner and healthcare leader, Grant Thornton, said, â€œWith the growing interest from government and private players, the Indian biotech sector has a promissing future. The Asian biotech sector witnessed 43 M&As and private equity deals worth $121 million (550 crore) and 93 alliances/ collaborations in 2010. It is estimated that the bioagri and bioservices sectors will witness more collaborations and gain more contract research opportunities. Inviting foreign companies to invest and collaborate in China, Mr Yang Weigang, deputy director general, Beijing Municipal Science and Technology Commission, said, â€œThere are more opportunities for partnership and collaboration. The biopharma market in China was estimated at $179 billion (810,000 crore) in 2010â€?. In his address, Prof Abbas S Lotfi, director general, National Institute of Genetic Engineering and Biotechnology, Tehran, Iran, said that Iran is open for collaboration/ partnership with Indian biotechnology companies. Acknowledging the advancements in biotech, Mr ESL Narasimhan, Governor of Andhra Pradesh awarded YSR Innovation award to Ms Chaitanya Reddy of Vishnu Dental College, for the project 'Manually operated mobile air compressor' for use in the dentistry and the BioAsia Young Minds Award was given to Mr Vignesh Sridharan from Chennai. The Iranian Biotech of Republic of Iran received the best Trade Show Award with first runner up being Sri Biotech from Hyderabad and second runner up, Lab links Biotech, Bangalore. The ninth edition of the event is scheduled for February 09-11, 2012. Suchithra Pillai in Hyderabad ]]> <![CDATA[KBITS workshop highlights Millennium Biotech Policy II]]> https://biospectrumindia.com/news/95/2344/kbits-workshop-highlights-millennium-biotech-policy-ii.html https://biospectrumindia.com/news/95/2344/kbits-workshop-highlights-millennium-biotech-policy-ii.html Tue, 15 Mar 2011 11:56:00 +0530 Dr Kiran Mazumdar-Shaw, CMD of Biocon, addresses the gatherings at the KBITS workshop on Millennium Biotech Policy II The Karnataka Biotechnology and Information Technology Services (KBITS) and the Association of Biotech Led Enterprises (ABLE) organized a workshop in Bangalore on February 19, 2011. The workshop titled “Millennium Biotech Policy II - An endeavor of the Karnataka government for sustainable growth of the industry” aimed to create awareness on the existing policies, for the development of biotechnology. Dr Kiran Mazumdar-Shaw, CMD of Biocon, who also heads the Vision Group on Biotechnology in Karnataka, inaugurated the workshop. Mr Ashok Kumar Manoli, principal secretary, Department of IT, BT and Science & Technology, Government of Karnataka, and other prominent people from the biotech fraternity were also present at the event. Speaking on the topic, ‘Sustainable growth of BT industry in this decade’, Dr Mazumdar-Shaw said that the skill and capacity building are vital for biotech growth in India. Commending the government’s effort, by allotting fund worth $200,000 (90 lakh) for establishing Finishing Schools, she opined that with right training, Karnataka can become a major player in biotech sector. The workshop had three key sessions focusing on fiscal; funding and R&D support; and infrastructure support and HR development for sustainable growth in biotechnology. During the first session, speaking about the incentives and funds available to the biotech industry, Mr Manoli said, “Out of the 100 odd companies in Karnataka, only 34 companies have availed entry tax exemption. Karnataka’s biotech companies have not utilized the policy and its incentives to the full extent.” Dr KK Narayanan, managing director, Metahelix Life Sciences, who co-chaired the session on ‘Fiscal, funding and R&D support’ was of the opinion that lack of awareness among industrialists was one of the reasons why the policy was not exploited enough. Mr N Suresh, group  editor, BioSpectrum, who was one of the panelists said that the funding drought needed to be tackled to encourage entrepreneurs and industrialists alike. Mr Divakar Rao, member, Karnataka Vision Group on Biotechnology also shared his thoughts on the topic. Commenting on the infrastructure support, Mr Vijayshankar, additional managing director, KBITS said, “Bangalore Helix, an outcome of the first biotech policy, hosts many reputed organizations such as Institute of Bioinformatics and Applied Biotechnology (IBAB) and Center for Human Genetics. The second biotech policy will take that growth to the next level.” Dr Krishnaraj, HoD at Institute of Agri BioTech, said, “The Karnataka government’s efforts on providing funds for instrumentation encourage research initiatives.” Dr Gayatri Saberwal of IBAB, Mr Naveen Kulkarni, MD and CEO, Polyclone Biosciences and Dr Vinay Konaje, founder and director, Navya biotech were among the other panelists who discussed the importance of infrastructure and its impact on growth. Dr Maulishree Agrahari from PES Institute of Technology, Bangalore; BS Gaurishankar from Siddaganga Institute of Technology, Tumkur; Dr Sarvamangala Patil, Vishweshwaraih College of Applied Sciences, Gulbarga; Dr Nagaveni, Maharani Lakshmi Ammanni College for Women, Bangalore; Prof. T Veerabasappa Gowda, HoD- biotechnology, JSS College of Arts,Commerce & Science, Mysore; and Dr Smitha Hegde, HoD, PG-Department of Biotechnology, St Aloysius College, Mangalore; shared their views on human resource development for the  sustainable growth of the industry. The workshop provided a platform for industrialists, entrepreneurs, academicians and government officials to engage in an open house discussion about the ways and means to improve education, investment and R&D in the field of biotechnology in Karnataka. Romi R in Bangalore ]]> <![CDATA[Biotech's changing landscape]]> https://biospectrumindia.com/news/95/2002/biotechs-changing-landscape.html https://biospectrumindia.com/news/95/2002/biotechs-changing-landscape.html Tue, 15 Mar 2011 11:54:00 +0530 A few hours after the presentation of the national budget by Finance Minister, Mr Pranab Mukherjee, on February 28, 2011, I happened to meet one of the industry leaders at a city restaurant. We had the option of chatting over a cup of coffee in both the air-conditioned and non-air conditioned sections of the place. Naturally we chose the air-conditioned section, because we were not sure how long this luxury will last. After all, the Finance Minister had announced a 10 percent service tax on medical treatments done at air-conditioned hospitals. If it is hospitals this year, the same logic for taxation could be extended to many other categories of establishments. My industry friend was worried because his company has significant research facilities and it is all air-conditioned. Most biotech and pharma research today is carried out at modern facilities where air-conditioning is one of the most basic needs. And high-end research and modern offices in the country’s fast growing cities cannot do without air-conditioning. Would the government slap a tax on my labs next year, he asked me worriedly. I could not reassure him because Mr Mukherjee has opened a new route to extract more from already taxed  sections of the society. Hospitals are important to the biotech industry, except the agribiotech sector. Because, biotech drugs are still very expensive and are used by patients who get their treatments at high-end hospitals. There will be pressures on pricing as hospitals try to cut costs. We turned our attention to rest of Mr Mukherjee’s budget and what was in it for the biotech  sector. To our surprise, we found that that the budget has just bypassed the biotech sector. This was not the case when BioSpectrum was launched eight years ago. As we celebrate eight years of catalyzing the growth the of the industry, one can only nostalgically look back at the series of industry-friendly reports we had covered in these columns. The industry’s request for a five-year tax holiday on home-made biotech products has been brushed aside. A longer time frame for tax-free regime for biotech special economic zones (SEZs) has not been granted. The request to abolish customs duty on high-tech equipments imported for research purposes by the industry has not been accepted. The list of unfulfilled demands from the industry is long. What conclusions can one draw from this? It could mean that at the national level, the government does not want to bestow any special status to biotech sector. Or there is a belief among the policy-makers that everything needed to stimulate the biotech sector has been done and there is no need for any special attention now. We don’t know which one of this is true. The industry certainly will have to wait for sometime to figure it out. On the other hand, governments at the state level are rolling out red carpets. Karnataka  government has been at the forefront of this and even had a successful interaction with the industry in mid-February to tweak its revised Millennium Biotech Policy. Karnataka’s biotech secretary, Mr Ashok Kumar Manoli has one big dream now. He is willing to roll out the red carpet for the biotech investor who commits at least $20 million (100 crore) investment in the country. In this backdrop, we thought it was better to find out from the industry itself about the prospects. So the Special Story “Will India biotech hit $10 bn by 2015” is an attempt to read the minds of the industry leaders. I will leave it to you to read the undercurrents of the many observations made in this report and give me the feedback. Narayanan Suresh Group Editor sureshn@cybermedia.co.in ]]> <![CDATA[Indo-Dutch Collaboration in vaccines on the radar]]> https://biospectrumindia.com/news/95/2039/indo-dutch-collaboration-in-vaccines-on-the-radar.html https://biospectrumindia.com/news/95/2039/indo-dutch-collaboration-in-vaccines-on-the-radar.html Tue, 15 Mar 2011 11:48:00 +0530 Active collaborations between Indian and Dutch vaccine organizations are currently underway and can bridge the demand-supply gap in vaccines for neglected diseases in both the countries. Life sciences constitute a key sector in the overall economic growth of the Netherlands.  Today, the sector represents about three percent of the country’s GDP and employs 54,600 people. In 2006, a total of 935 life science organizations generated a turnover of €15.9 billion, making the industry one of the key pillars of the Dutch knowledge infrastructure. While 150 of these companies are R&D oriented, the others focus on health related R&D, including production, distribution, commercialization and other correlated services. Various stakeholders in the country are developing a growth chart for its burgeoning vaccine industry. Several steps are being taken, including permutation-combination of various road maps, in-house R&D projects in companies, Public-Private Partnerships (PPP) between the Dutch Government, the industry and the academia and inking partnerships or licensing deals with companies based in Netherlands with various firms in the developing nations of the world such as India. Vaccine Industry in the Netherlands Today, around 3.2 percent of the country’s total spending budget goes into vaccines and it boasts of being the seventh biggest spender in vaccines in the world. Moreover, the Netherlands Vaccine Institute is the only public-run organization in the world to produce inactivated polio vaccines. Crucell, a major player in the Dutch vaccine market which produces 12 different paediatrics, travel and endemic vaccines, has now been acquired by the pharmaceutical giant, Johnson and Johnson (J&J). The combined entity will see leveraging of strengths with Crucell using J&J’s expertise and network. Crucell is the second largest independent vaccine player in Europe and the sixth largest in the world with an annual turnover of €365.4 million for 2010. The vaccine industry in the Netherlands comprises several large and small firms including Abbott and Intervet among others. Abbott, which was previously known as Solvay Vaccines, is another firm that focuses on inactivated Influenza vaccine. Intervet, which was a part of Organon BioSciences and is now owned by Merck, is one of the world’s largest veterinary vaccine companies. Currently, Intervet is being partnered with Merial of Sanofi-Aventis to form a new joint venture, which will by far be the largest veterinary pharmaceutical company in the world. This apart, the sector also constitutes various small biotech start-ups mostly based on single-technology, such as Mucosis, ISA Pharnaceutical and DCPrime. From the Government’s side, the Netherlands Vaccine Institute (NVI) has played a major role in the development, production and  supply of vaccines. Prof Dr Han van den Bosch, currently professor extraordinary at the Athena Institute of the Free University in Amsterdam, while speaking about NVI says, “The NVI  is one of the last public vaccine companies in the world, until recently responsible for the national vaccination program (RVP) and also producing and developing a modest number of vaccines such as inactivated Polio.” The NVI supplies three million vaccine doses, including DTP-IPV-Hib, MMR and hepatitis B that is needed for the National Immunization Programme every year. The Institute has also manufactured a smallpox vaccine that will offer protection from a bio-terrorist attack. The Top Institute Pharma (TI Pharma), a PPP initiative funded by the Dutch Government and a consortium  which brings together the industry and academia on one platform, has several projects that are aimed at developing and optimizing vaccines. Today, TI Pharma has 45 companies and 27 research institutes under its wings and its research programmes are based on the Priority Report of the WHO, which enlists priority medicines for certain disease areas in certain areas of the world. Netherlands-India Vaccine Collaboration Dutch vaccine companies and institutes are now looking at the 2,180 crore Indian vaccine market for  inking collaborative deals. The Dutch are mainly looking to establish partnerships in the field of R&D of vaccines for neglected diseases including malaria, chikungunya, influenza and cancer.  Ms Wilma Witkamp,  from the Netherlands’ Ministry of Health, Welfare & Sport, says: “Netherlands offers good infrastructure for vaccine R&D. At this moment Netherlands is not actively looking for supply partnerships but is interested into developing joint research programmes in vaccinology with India.” “Both countries share the need to develop treatments for neglected diseases. A partnership can fill up the missing links that we are looking at in our projects. In the field of neglected diseases, Indian companies have access to field sites, which some of our partners do not have and on the other hand, Netherlands has the technological know-how and the large network of life sciences companies.” says Ms Jayasree Iyer, senior programme manager at TI Pharma. The Netherlands offers its own set of benefits to Indian vaccine firms.  Says Doortje van Unen,  business developer for BioPort Europe, “Netherlands has a favorable tax structure and a patent box. Also, India is attracted towards this market due to its favorable distribution network and easy logistics system. There is a lot of demand in avenues like vaccines, oncology and immunology.”  BioPort Europe, which is a portal set up a year ago by the Government to accentuate collaborations between Indian and European companies in the field of life sciences, will  be a channel via  which small and medium sized company in India could enter the stringent European market. The Dutch NVI has a long history with Pune-based vaccine company, the  Serum Institute of India. In  2007, the Serum Institute of India got a license to produce a vaccine against Hib (Haemophilus influenzae Type B) from the Indian government, which  was developed using technology transferred from the Netherlands Vaccine Institute. “This was the first time that a developing country was able to develop and get a license for a Hib vaccine through joint development and technology transfer,” adds Prof Bosch. NVI is now supplying bulk material for Salk vaccine, or inactivated polio-virus vaccine (IPV), to Indian companies and has been asked by the WHO to develop the safer Sabine-IPV vaccine for technology transfer. “Once developed, it will highly benefit India, where the last few remaining cases of polio in the world are still to be found,” adds Prof Bosch.  Furthermore, Nobilon has sub-licensed the technology for production of Live Attenuated Influenza Vaccine to Serum Institute of India through the WHO pandemic preparedness program, which resulted into the recent marketing of Nasovac by Serum Institute of India in India and other markets as well. Also, Intervet owns a subsidiary in India that allows it to perform activities including R&D, production,  manufacturing and supply of veterinary vaccines.  Looking at these developments, several consortium are keeping a close tab on the market. The trigger factor being that both countries are formulating strategies for the development of vaccines in the field of neglected diseases like malaria. Informs Mr Iyer, “ TI Pharma started a neglected disease portfolio under European Solutions Enterprise for Neglected Diseases (euSend) which currently has eight projects for diseases like chikungunya  and other infectious diseases. The budget is around  €3.6 million. The problem is finding partners for these projects and that is how we got  into discussions with interested Indian companies.” India is definitely on the radar of  ImmunoValley, a by-product of Utrecht University and  a consortium of 27 organizations that was formed in 2008 with the idea of knowledge and infrastructure sharing between partners. ImmunoValley foresees India growing as a high-tech innovation ground in the coming years. This they believe, can be accomplished when they partner  with the companies having expertise in the technological know-how.  ImmunoValley has developed different tools such as a proprietary database of all Dutch scientists in the field of infectious diseases that can be very helpful for the Indian scientific community. While speaking about Crucell, Ms Witkamp says, “India could be an attractive market for Crucell especially for its pentavalent vaccines.” In the past, India was favored destination for the company in conducting global clinical trials for its Monoclonal Antibodies (Mabs) Rabies product. While speaking about Indo-Dutch colloboration,  Mr Iyer concludes that, “Vaccines of tomorrow are mainly  in areas like rabies, malaria and chikungunya. Definitely, there will be Dutch players who will be a part of tomorrow’s vaccines.” Nayantara Som in Mumbai ]]> <![CDATA[Drug discovery & Development: GAME CHANGERS]]> https://biospectrumindia.com/news/95/2195/drug-discovery-development-game-changers.html https://biospectrumindia.com/news/95/2195/drug-discovery-development-game-changers.html Wed, 09 Feb 2011 14:53:00 +0530 Research & development is the lifeblood of the biotech industry. BioSpectrum in this special issue has brought together some of the R&D leaders from the industry to share their thoughts on the â€œGame Changers in Drug Discovery & Developmentâ€?. Later this month, BioSpectrum is organizing the second edition of the BioSpectrum Technology Forum 2011 (BSTF 2011) which has a series on interactive panel discussions with the same theme: â€œGame Changers in Drug Discovery & Development.â€? This two-day forum will be held in Bangalore on February 22-23, 2011. During these two days, senior scientists and R&D heads from public and private sectors across the country will be sharing their insights & experiences on topics such as â€œStem Cells & Gene Therapy, Next Generation Innovation, Strengthening the Drug Pipeline, Computer-aided Drug Discovery, and Novel Approaches to Drug Discovery.â€? In the ensuing pages, read on some insights from these R&D leaders: (The views expressed in these articles are strictly the personal views of the author. The trademarks or trade names mentioned in this paper are property of their respective owners and are included for reference only and do not imply a connection or relationship between the author and these companies or BioSpectrum.) Mr Venkat Jasti,chairman & CEO, Suven Life Sciences Dr Arumugam Muruganandam, Chief Scientific Manager Research & Development Biocon Dr Chandra Viswanathan, Head, Regenerative Medicine, Reliance Life Sciences Dr Gopal Dasika, VP, Biotech, Unichem Dr Samuel JK Abraham, Director, Nichi-In Centre for Regenerative Medicine Dr Janakiraman Ramachandran, Chairman & CEO Gangagen Inc Mr BN Manohar, CEO, Stempeutics Mr Ganesh Sambasivam, Founder & CSO, Anthem Biosciences ]]> <![CDATA[Biopharma outperforms pharma market]]> https://biospectrumindia.com/news/95/2273/biopharma-outperforms-pharma-market.html https://biospectrumindia.com/news/95/2273/biopharma-outperforms-pharma-market.html Fri, 04 Feb 2011 12:00:00 +0530 The biopharma business of Biocon, a leading biotech company in India, posted a strong growth in revenues in Q3FY11 with the strong sales revenue from immunosuppressants, statins and branded formulation segments. â€œCommenting on the financial performance, Dr Kiran Mazumdar-Shaw, chairman and managing director of Biocon, says, â€œBiocon has delivered the highest ever PAT this quarter and has crossed the $20 million (100 crore) mark. The operating margin has also increased to 24 percent this quarter reflecting the improved quality of earnings. This marks an important growth milestone that enables us to invest in advancing our research programs and expands our manufacturing and marketing partnerships, which we believe, are catalysts to future growth.â€? Biocon noted that six verticals in branded formulations â€“ diabetology, oncotherapeutics, nephrology, cardiology, dermatology and comprehensive care â€“ have posted a combined year-on-year (YoY) growth of 32 percent. In diabetology, the response for Insugen 100 i.u. has been very encouraging. This launch will help the division increase its market share in the human insulin vials space. Overall, the insulin portfolio has grown by 40 percent last year. Biocon launched a separate division called Immunotherapy Division in September 2010 with a vision to present a portfolio of unique, effective and affordable medicines predominantly for the treatment of immune-related dermatological disorders. The current portfolio at the division comprises of Tbis (Tacrolimus) and Picon (Pimecrolimus). Syngene, an internationally-reputed contract research and manufacturing organization with multi-disciplinary skills in chemistry and biology services and a subsidiary of Biocon, has gained momentum in the current quarter with a 21 percent growth in topline and a three percent improvement in EBITDA margins; and increased traction in biologics and integrated research services are expected to drive growth in the year ahead. Commenting on the business outlook, Mr Peter Bains, who has taken interim charge of Syngene after the retirement of Dr Goutam Das in December 2010, says, â€œThe rationale for external R&D is no longer related to or restricted to cost, but it is also about value-added services that enhance the success of drug development programs. Full-time equivalents (FTEs) have made way for preferred suppliers of integrated offerings that are now replaced by strategic development partnerships. I believe Syngene and Clinigene are in a unique position to offer integrated, end-to-end drug discovery and development services both for small molecules and biologics.â€? Similarly, Panacea Biotec, India's progressive research-based health management company involved in research, manufacturing and marketing of branded pharmaceutical formulations, vaccines and natural products grew by 25 percent in the quarter ended December 31, 2010. The vaccine segment grew by 29 percent with a net turnover of $ 46.19 million (212 crore) as compared to $35.80 million (164 crore) during the corresponding period of previous fiscal. 'Syngene and Clinigene are in a unique position to offer integrated, end-to-end drug discovery and development services both for small molecules and biologics' The pharmaceutical formulations segment grew by 12 percent with a net turnover of $15.46 million (71 crore) as compared to $13.76 million (63 crore) during the corresponding period of previous fiscal, supported by 80 percent growth in the export of pharmaceutical formulations in this quarter. The increase in turnover resulted in substantial growth of 236 percent in its PBT during the quarter under review. Panacea Biotec also reported significant growth of 484 percent in its PAT during the quarter under review. Dr Rajesh Jain, joint managing director, Panacea Biotec, says, â€œPanacea Biotec continues to register significant and sustainable growth during the quarter ended December 31, 2010, both in terms of revenues and profits as expected. This sustained performance is an outcome of constant focus each employee at Panacea Biotec is giving on creating value for our stakeholders. Their commitment to processes and building a team of committed people with Encouraging, Accelerating, Supporting and Expanding (EASE) formula would ensure consistent performance in years to come. The growth for Panacea Biotec can be attributed to widening of its product portfolio during the quarter under consideration. The company launched new products namely Lenomust capsules 5mg, 10mg & 25mg (multiple myloma for blood cancer) under its OncoTrust SBU; Renhold tablets (protein for dialysis patients) under its Nephrology SBU; Exeroz 5mg & 10mg tablets (for reduction of cholesterol) under its Diacar Alpha SBU; and Fiberfos powder 90gm and Gush powder 90gm (both for constipation) under its SBUs Growcare and Procare, respectively. On an average, the growth of biopharmacetical companies was 20 percent higher than the pharmaceutical companies during the Q3FY11. Dr Reddy's Laboratories, a global Indian pharma company, has registered 10 percent growth in Q3FY11. On the contrary, Sun Pharma, an integrated, specialty pharmaceutical company witnessed a strong growth in Q3 with its net sales/ income from operations at $ 348.58 million (16.01 billion), growing 57 percent over Q3FY10. This is on account of its newly acquired entity, Taro's revenue being included this quarter. Consolidated revenues of Dr Reddy's Laboratories, which has developed and launched Reditux (rituximab) - the world's first generic monoclonal antibody were at $424 million (1,900 crore) in Q3 FY11 versus $386 million (1,730 crore) in Q3FY10 with year-on-year growth of 10 percent. During the quarter, the company launched 42 new generic products, filed 21 new product registrations and filed nine Drug Master Files (DMFs) globally. The company has entered into two settlement agreements with AstraZeneca in US related to the ANDA filed for the generic versions of AstraZeneca's Nexium (esomeprazole) and Accolate (zafirlukast). Under the terms of the esomeprazole agreement, AstraZeneca has granted Dr Reddy's a license, subject to regulatory approval, to launch a generic version of esomeprazole delayed-release capsules on May 27, 2014, or earlier in certain circumstances. The terms of this agreement have not been disclosed. Commenting on the financial performance of Sun Pharmaceutical Industries, Mr Dilip Shanghvi, chairman and managing director, Sun Pharmaceutical, says, â€œOverall performance across most markets continues to be in line with our expectations. Medium to long-term priorities remain focused on building a stronger presence in our key as well as emerging markets.â€? â€œTowards this we continue to invest in enriching our product pipelines for each of the business segments, work towards gaining market share in key products and therapy areas as well as enhance our capability to meet the exacting regulatory standards across the world. Improving Taro's long-term sustainability and growth potential is in progress, even as we continue to evaluate other strategic opportunities,â€? he concludes. Narayan Kulkarni in Bangalore ]]> <![CDATA["Indian bioinformatics segment set for growth"]]> https://biospectrumindia.com/news/95/6042/indian-bioinformatics-segment-set-for-growth.html https://biospectrumindia.com/news/95/6042/indian-bioinformatics-segment-set-for-growth.html Fri, 04 Feb 2011 11:57:00 +0530 Dr Abhay Jere, associate vice president – life sciences, Persistent Systems, Pune After extending collaboration with a host of prestigious universities and institutes in the North America, Pune-based Persistent Systems is now looking at replicating the same in the burgeoning Indian life sciences market. In an interview with BioSpectrum, Dr Abhay Jere, associate vice president – life sciences, Persistent Systems, throws light on the recent initiatives of the company in bioinformatics space. Q What are the focus areas of Persistent within the life sciences sector in India? Dr Jere: Life sciences has contributed about 15 percent of our business. We are ready to grow and ready to expand. We have a team of 500-plus people and are always on the look out for ways to contribute more to life sciences, especially in a country like India. Our focus areas are bioinformatics, clinical informatics, instrumentation and LIMS. In the area of research, we are looking at systems biology and data analysis, especially in  next-generation sequencing. We will venture into personalized medicine space. Q Could you throw light on the recently introduced BioCrats Connect? Dr Jere: At Persistent Systems, we realized that interdisciplinary interaction within life sciences is hardly happening. For example, a physicist will hardly talk to a biologist and comprehensive interaction was missing. So we decided to come up with a platform, BioCrats Connect, where people, interested in contributing to the life sciences space can interact with medicos, biologists, pharmacists and then churn out interdisciplinary projects. We will be monitoring the status of the projects. Persistent  Systems may or may not be a part of it because ultimately the projects should be of relevance to the Indian life sciences sector. We will take initiatives to make this community more vibrant because usually people discuss ideas and many a times those ideas are never taken forward. Meetings between these professionals will be held every quarter and we will also initiate bi-monthly meetings. This apart, we are in the process of setting up a web portal. We plan to have webinars and blogs. In the near future, we are hoping to take many such  initiatives in biosciences. Q Persistent looks at collaborations with universities, what are the key initiatives on this front? Dr Jere: We extend collaborations with institutions and universities. We have a strong collaboration with Washington University, US. In India, we collaborate with the National Cancer Institute of National Institutes of Health (NIH), for an initiative related to cancer grid called the cancer Biomedical Informatics Grid (caBIG)  in collaboration with Washington University. We have been named a caBIG Support Service Provider for them. Other collaborations are with Indiana University, Yale University, Harvard and Broad Institute (MIT).  Apart from universities, we are also working with companies such as Agilent and we have developed more than 20 products for them. We are also working with Life Technologies. Persistent Systems and Indiana University together have come up with research set-up for informatics in life sciences. In India, we have also collaborated with National Institute of Virology (NIV), Pune and International Center for Genetic Engineering and Biotechnology (ICGEB), New Delhi. Q What is the role played by Persistent in the caBIG initiative? Dr Jere: Persistent Systems has been named a cancer Biomedical Informatics Grid (caBIG) Support Service Provider by the National Cancer Institute (NCI). So, all cancer research-related data would be available online which would be available for other researchers. Along with Washington University, we have built multiple tools for this caBIG initiative. CaBIG Support Service Providers are independent entities that are approved by NCI as meeting specific criteria for performance of support services related to caBIG needs. Services rendered by caBIG Support Service Providers to their clients are established under separate business arrangements organized by and between the service provider and its clients. The caBIG program has licensed Persistent as a part of its effort to provide support for greater involvement and adoption by cancer centers, hospitals and researchers nationwide. Persistent is licensed as a caBIG Support Service Provider licensed in all categories of support. Q What are the focus areas for Persistent as part of its collaboration with NIV, Pune? Dr Jere: We have built an entire data management system for swine flu at NIV, Pune. We deployed the system a year back. Currently they are using the system and are planning to take it to other places. The software, VirusLIMS, is a secure web-based information management system that is designed to efficiently manage field and laboratory information for clinical and laboratory testing across the institute and related centers. The VirusLIMS software will enable NIV to effectively manage increasing sample in-flow as well as ensure documentation of all phases of laboratory testing and reporting activities, aiding compliance with standards defined by agencies such as Indian Council of Medical Research (ICMR), Centers for Disease Control and Prevention (CDC) and the World Health Organization (WHO). The software further provides the infrastructure for timely sharing of laboratory information with health agencies — which is crucial for rapid and effective response to outbreaks of infectious diseases such as chikungunya, swine flu and avian influenza. Q Are there any apprehensions among companies on universities being averse to adopting high-end technology tools? Dr Jere: Initially, I did have apprehensions that we will be facing such challenges, but, when I started interacting with universities, the response was pretty positive. In India, there are a lot of public-private partnership (PPP) initiatives and there has been a wide acceptance to this model. It takes some time to work out realities and now I am keen on working with the industry. I do see the bioinformatics segment in India growing in the next two years. Q What is the business strategy for the future? Dr Jere: I would not be able to comment on short-term plans but as far as long-term plans are concerned, I would say that our main focus would be on research in the areas of systems biology and data analysis. Nayantara Som in Mumbai ]]> <![CDATA[Biocon announces IN-105 results]]> https://biospectrumindia.com/news/95/6541/biocon-announces-in-105-results.html https://biospectrumindia.com/news/95/6541/biocon-announces-in-105-results.html Fri, 04 Feb 2011 11:53:00 +0530 Biocon, Asia’s leading biopharmaceutical enterprise, released preliminary data from a recently concluded clinical study conducted in India, on IN-105, its novel oral insulin candidate for the treatment of diabetes. Initial data analyses show that IN-105 did not meet its primary endpoint of lowering HbA1c levels by 0.7 percent as compared to placebo although an unexpectedly high placebo response was also observed. Post hoc analysis of self monitored blood glucose levels in the IN-105 arm and the placebo arm indicated large reductions in pre-meal glucose levels in the placebo arm strongly suggestive of behavioral modification, and which might have confounded the primary endpoint outcome. Additionally, in further post hoc analyses, significant reductions in HbA1c levels as compared to placebo, and HbA1c reductions of up to 0.8 percent were observed in the IN-105 arm of several subsets of the studied patient population. Further assessment of the data is on-going. Dr Kiran Mazumdar-Shaw, CMD of Biocon, said, “Based on these encouraging results, Biocon is committed to continue its global development of IN-105 in partnership with a global pharmaceutical partner for which we plan to initiate partnering discussions.” On secondary safety endpoints, IN-105 demonstrated an excellent overall safety profile with no incidence of serious adverse events, and no occurrences of clinical hypoglycaemia. Data also shows that the drug is weight neutral and non-immunogenic. Monsanto announces nine new projects Monsanto, a global bioagri company that provides solutions and agricultural products, announced several projects across platforms, and crops designed to improve farmers’ on-farm productivity and profitability as part of its annual pipeline update. The company announced key projects and insisted on pipeline collaboration with Germany-based BASF Plant Science, which was expanded to include wheat. Yield and stress projects advancing phases this year include nitrogen-utilization corn, second-generation higher-yielding soybeans and higher-yielding/stress tolerant wheat. Following last year’s record-breaking 11 project advancements, this year’s nine advances are testament to the depth of the company’s R&D pipeline. Additionally, four of the advancements are new projects that were added to the pipeline, demonstrating that discovery work brings new opportunities. ICMR plays down fears on congo fever After a first ever case of human infection with Crimean Congo Hemorrhagic Fever (CCHF) virus being reported from Ahmedabad, Indian Council for Medical Research (ICMR), an apex body for the formulation, coordination and promotion of biomedical research in India has assured that CCHF outbreaks can easily be controlled by proper hygiene and infection control measures in the hospitals where patients are admitted. Earlier the tests conducted at National Institute of Virology (NIV), Pune, confirmed the presence of CCHF virus in blood as well as urine samples of a patient. The CCHF virus is known to be transmitted among animals through ticks. There is serological evidence of CCHF infection being present in India in animals which however do not get the disease. It does not produce disease in animals but kills 20-40 percent of human beings who get the disease. So far, a team of doctors and technicians surveying six villages within a radius of five kilometers of Kolat which is about 40 kms from Ahmedabad in Gujarat detected 78 persons with symptoms of the viral fever. CCHF is a viral haemorrhagic fever of the Nairovirus group. The disease was first described in the Crimean in 1944 and given the name Crimean haemorrhagic fever. The disease is endemic in many countries in Africa, Europe and Asia, and in 2001, cases or outbreaks have been recorded in Kosovo, Albania, Iran, Pakistan, and South Africa. Qteros, Praj sign marketing deal Qteros, the US-based developer of a unique and highly-efficient consolidated bioprocessing (CBP) platform for the low-cost production of cellulosic ethanol, and Praj Industries, a leader in the development of innovative technology and engineering solutions for the production of biofuels and biochemicals based in India, have announced a strategic partnership to accelerate commercialization efforts for industrial-scale cellulosic ethanol production. The agreement leverages both Qteros’ broadly patent protected and highly-flexible CBP platform with Praj’s research capabilities and its technology, process design, engineering and construction expertise to deliver fully-integrated engineering design packages for the low-cost production of ethanol from a broad variety of non-food based feedstocks. Qteros and Praj will collaborate on a highly-focused, multi-year development program with the objective of rapidly developing and commercializing process design packages (PDPs) that enable cellulosic ethanol production using Qteros’ Q Microbe-enabled CBP platform and Praj’s technology and expertise in the conversion of biomass to ethanol. This unique licensing model serves to provide both a highly-efficient and low-cost solution to the market, while also allowing Qteros and Praj to deploy their capital in an efficient and leveraged manner. Importantly, the companies plan to retrofit Praj’s existing pilot plant in Pune with Qteros’ technology platform, which will then become the foundation for accelerated production scaling as part of its commercial planning. Zero swine flu causality in 2011 With the number of reported deaths being nil out of the 10 laboratory confirmed cases during the first week of 2011, the year has started on good note on the swine flu casualities. According to the Indian Health Ministry’s statewise data of influenza H1N1, for the week ending January 9, 2011, the total 10 death cases were reported from different parts of the country. The four cases were reported from Tamil Nadu and one each from New Delhi, Maharashtra, Kerala, Karnataka, Punjab and Gujarat. Out of that, not a single death has been reported so far. The lab confirmed cases since May 2009 stood at  46,152. Out of that, the total confirmed death cases were numbered 2,728. Again, since May 2010, the total number of the lab confirmed cases that were reported stood at 3,282. Out of that, the reported number of deaths were 246. Besides the efforts made by Indian Health Ministry, the international agencies also played a good role in tackling swine flu. The World Health Organization  (WHO) provided the financial assistance amounting to about $533,000 (2.43 crore) besides the technical guidance from time to time to conduct district level training for rapid response teams. UNICEF, another UN agency, supported the Indian government in developing information, education, communication (IEC) materials for print and audio-visual media and for field publicity. FBAE completes a decade of activity The Foundation for Biotechnology Awareness and Education (FBAE), a non-profit, grass root society formed to support sustainable development through biotechnology awareness and education in India successfully completed a decade in science-based activity. With academicians, scientists and researchers as members, it was formed to bring together the global scientific community in 2001.Inaugurated by Prof. G Padmanabhan, former director, Indian Institute of Science, Bangalore, and presided over by Dr S Shantharam, the FBAE has since then actively conducted and participated in various workshops and seminars all over the country. The foundation creates scientific awareness about modern biotechnology and educate the public and stakeholders about the perceived and potential risks and benefits of this emerging technology. Qiagen opens subsidiary in India Netherlands-based biotech company, Qiagen has formed an India subsidiary, Qiagen India, and has started direct sales in the country. Until now, Qiagen products have been sold in India through distributor partnerships. Qiagen has been active in India since 1995 and has developed numerous initiatives, partnerships and a strong network. The company expects that this enhanced presence will further contribute to its position in the market. The new office in New Delhi is an initiative to expand Qiagen’s footprint in emerging regions. Nixon Biotech develops anti-HIV formulation Nixon Biotech, an Indian biotech company, has developed a herbal mineral immunity enhancer for HIV/AIDS to inactivate the virus without any toxic effect on the body. If it proves its safety and effectiveness without any side-effects and gets green signal from the regulators in India, then this will be the first anti-HIV Ayurvedic formulation in the world to tackle AIDS. Currently, the anti-HIV formulation is being availed by the patients who are being treated at its campus. However, the company is yet to have the manufacturer’s license and has applied for the same. Nixon Biotech is an ayurvedic pharma company that has been working on the natural AIDS immunity enhancer. The company started working on the project since 2005. According to the company, the blend of minerals, antioxidants and herbs are combined and optimized to give the body the essential nutrients required for improving general condition and overcoming weakness. This natural formulated medicine helps in promoting the protein and carbohydrates in the metabolism of body. Mr Ravi Goel, chairman of Nixon Biotech said, “The dosages for the patients are recommended in form of IC-50 and IC-80. While the IC-50 reduces the virus by 73-95 percent, the IC-80 completely wipes out the virus.” Hilleman Lab project to assess vaccine formulation The MSD Wellcome Trust Hilleman Laboratories has announced its frist project, it will be a feasibility study into how new technologies might be used to develop a rotavirus vaccine designed specifically with developing country needs in mind. Formulations based on dissolving thin strips or granules will be examined for their potential to improve product stability, transportation and affordability. The therapeutic focus of the project has been selected because of the tremendous global impact of rotavirus diarrhea on childhood mortality. If the initial study is successful, options to further develop the technology for rotavirus and other oral vaccines of importance to developing country health will be explored. “Many first-generation vaccines have not been developed with the specific needs of countries with poor infrastructure for vaccine delivery in mind. This is a much needed exploration of how to tackle one of the greatest public health and logistics challenges in the developing world — distributing life-saving vaccines without the requirement for large bulk shipments, expensive warehousing and costly, difficult-to-maintain refrigerated shipping paths from the manufacturing plant to the patient,” said Dr Altaf A Lal, CEO, Hilleman Laboratories. The project is a three-way collaboration between the Hilleman Laboratories, MSD and Medicine in Need. Aurobindo Pharma announces strategic divestment India-based Aurobindo Pharma Limited (APL) has entered into a definitive agreement with China National Pharmaceutical Group Corporation (Sinopharm) to divest in its subsidiary company Aurobindo (Datong) Bio Pharma, China (ADBPL), subject to regulatory approvals. Sinopharm will acquire the shares through its subsidiary company Sinopharm Weiqida Pharmaceutical. ADBPL is engaged in manufacturing of 6APA, a derivative of Penicillin-G and most of its production is consumed by APL India. In past the performance of ADBPCL has been affected due to economies of scale and is incurring losses. After acquisition of 51 percent equity in ADBPL, the investors will further infuse capital to enhance its shareholding to 80.50 percent, reducing APL share in the JV to 19.5 percent. APL’s loan of $23 million to ADBPL will entirely be paid back. Sinopharm group will infuse sufficient funds to relocate plant as required by local government in China and significantly enhance capacity and downstream products leading to better economies of scale and reduced cost of production. APL’s investment of 19.50 percent will be strategic in nature to ensure uninterrupted supply of raw materials at competitive price. Over the past six years, APL has undertaken a paradigm shift from API to formulations business. Hence, the board feels that the said divestment is in the best interest of the company. ]]> <![CDATA[Five Padma Awards go to life sciences]]> https://biospectrumindia.com/news/95/1913/five-padma-awards-go-to-life-sciences.html https://biospectrumindia.com/news/95/1913/five-padma-awards-go-to-life-sciences.html Fri, 04 Feb 2011 11:51:00 +0530 Distinguished scientist Dr S Ramachandran; Dr K Anji Reddy, founder and chairman, Dr Reddy Group of Companies; Dr K Raghavendra Rao, founder, Orchid Chemicals; Dr Suman Sahai, founder of Gene Campaign with a distinguished scientific career in the field of genetics; and Mr Analjit Singh, founder and chairman, Max India; are among the 128 dignitaries who have been selected for  the Padma civilian awards this year. Dr S Ramachandran who has been chosen for the Padma Bhushan was the first secretary of the Department of Biotechnology (DBT), Government of India. The Chennai-born scientist’s works aimed at  developing modern biology through various DBT programs. Mr Analjit Singh, founder and chairman of Max India Group, a clinical research and healthcare company, has been conferred with Padma Bhushan Award. He has been the driving force behind the group’s sustained growth and success since the mid-1980s. Dr K Anji Reddy, a recipient of  Padma Shri in 2001, has been chosen for Padma Bhushan for his leadership role in developing Dr Reddy’s Laboratories as a top innovative drug research and discovery firm in India. Dr K Raghavendra Rao, founder of Orchid Chemicals, a leading pharmaceutical company headquartered in Chennai, has been selected for Padma Shri Award. With exports covering more than 75 countries, Orchid is ranked amongst the Top-5 cephalosporin producers in the world. Dr Suman Sahai, founder of Gene Campaign with a distinguished scientific career in the field of genetics was conferred with  Padma Shri in social work category. Who’s presenting where Dr Anji Reddy, Chairman, Dr Reddy’s Laboratories, @ BioAsia 2011, India Dr Lukas Utiger, Head, Lonza Bioscience, Switzerland @ BioAsia 2011, India Mr Krishna M Ella, Chairman & Managing Director, Bharat Biotech, India @ Vaccine World Summit, India Prof Nikolai Petrovsky, Research Director Vaxine, Australia @ Vaccine World Summit, India FABA announces Special Award 2011 Dr Davinder S Brar, chairman, GVK Biosciences and Dr Roger L Williams, CEO, United States Pharmacopeia (USP) have bagged Federation of Asian Biotech Associations (FABA) Special Award 2011. The awards will be presented to them on the inaugural day of BioAsia 2011 on February 22, 2011, in Hyderabad. ]]> <![CDATA[Avesthagen sequences Parsi gene]]> https://biospectrumindia.com/news/95/5823/avesthagen-sequences-parsi-gene.html https://biospectrumindia.com/news/95/5823/avesthagen-sequences-parsi-gene.html Fri, 04 Feb 2011 11:49:00 +0530 Avesthagen, India’s leading integrated systems biology platform company, has established its position as a key player in the successful application of next-gen technologies as it announces the completion of the first Parsi breast cancer whole genome sequence of a 74-year-old Parsi woman with a heritable form of breast cancer. The incidence of breast cancer in most populations is strongly linked to a genetic base but little is known about the variants at the present time. By employing whole-genome sequencing of affected individuals all genetic variants linked to the disease can be identified. This expected to lead to a broader understanding of breast cancer disease mechanisms, development of new diagnostic tests, and discovery of new drug targets and drug designing. The Parsis are a distinct minority population living in India and around the world with unique traits that include longevity, but also predispositions to certain diseases, including breast cancer. By comparing the genomes of Parsi individuals affected by breast cancer to healthy individuals, both within the community and in the general population, scientists will be able to identify those variations that are most likely to be responsible for breast cancer. This study is part of the Avestagenome project, a systems biology-based study on the Parsi population to determine the genetic basis of longevity and age-related disorders. The whole genome sequencing is being carried out in partnership with The Genome Analysis Center (TGAC), UK. DBT, NIH strengthen research ties To enhance the existing collaboration between neuroscience researchers in India and US, the Department of Biotechnology (DBT), Ministry of  Science & Technology, Government of India, has announced a new Indo-US Brain Research Collaborative Partnerships (BRCP) program. This is based on the joint statement signed by the DBT with the National Institute of Health (NIH), US. The purpose of the BRCP program is to support bilateral research collaborations between Indian and US investigators in the field of neuroscience, with an emphasis on understanding, treating and curing neurological, mental and addictive disorders. Specific areas of research may include studies of mechanisms underlying neurological, mental and addictive disorders and diseases, planning for population-based research and clinical trials, development of infrastructure for resource, tool and data sharing in addition to projects aimed at advancing global health research, particularly as it relates to the mission of the participating organizations. The condition put by the DBT/NIH is that the collaboration must involve Indian investigator(s) from an Indian institution and at least one investigator from the US institution. Successful proposals will include a well-presented justification for the bilateral collaboration, and detailed experimental approaches that will be completed by each component. Dabur Research ties up with Premas Dabur Research Foundation and Premas Biotech have announced a strategic global initiative to deliver an end-to-end solution in the area of preclinical drug discovery and development to their customers. The alliance combines the services offered by both the organizations to cover the entire range of solutions in preclinical drug discovery and development, manufacturing and toxicity profiling. The goal for both the organizations is to be able to provide their customers, both nationally and globally, a turn-key solution in their niche space of operation. The two organizations will be able to provide more comprehensive solutions to the clients as a single work-flow for the development of potential vaccines, biosimilars and bio-therapeutics. CSIR to set up drug research center In mid-January, the Indian Cabinet Committee on Economic Affairs approved the proposal from the Council of Scientific and Industrial Research (CSIR) for the revised cost estimate of its project of setting up a world-class drug research institute in Lucknow, Uttar Pradesh. The estimated cost of the project has been increased from $42 mn (190 crore) to $70 mn (322 crore). The project that took off in August 2007 is likely to be completed by March 2011. The state-of-the-art labs of the institute will enhance competitiveness in all disciplines. The proposed facility would generate a world-class infrastructure to nurture research and innovation in the area of drug discovery and development and benefit all sections of the society. ABLE-AG questions report on Bt cotton The Agricultural Group (AG) of the Association of Biotechnology Led  Enterprises (ABLE) has questioned the validity of the recently published research paper in the scientific journal, Current Science. The article in question was titled,  ‘Survival and reproduction of natural populations of  Helicoverpa armigera on Bt cotton hybrids in Raichur, India’ and has three joint contributors. Besides Mr MT Ranjith and Mr A Prabhuraj from the University of Agriculture Science, Raichur, the research also involved Mr YB Srinivasa of the Institute of Wood Science and Technology, Bangalore. According to the report, the researchers discovered individuals of helicoverpa armigera, the most prominent among bollworms in India, surviving on commercial Bt-cotton hybrids containing single (Cry1Ac) and double (Cry1Ac and Cry2Ab) genes in experimental plots of the University of Agricultural Sciences, Raichur.  However, while expressing its reservations, ABLE-AG observed that the study featured in December 2010 issue of the journal did not probe whether the bollworms survived because they have  turned resistant to the toxin in the GM cotton plants or because the amount of the toxins in the plants are below a minimum level needed to kill the insects. The  industry association believes that the results of the study seem to be preliminary in nature, and therefore can neither be used to generalize nor to extrapolate to all Bt crop technologies. It has emphasized that study must be repeated rigorously to really come to any scientific conclusion. However, ABLE-AG agreed that the results indicated the need for constant monitoring for the efficacy and durability of the technology and said that it has been equally emphasized by technology developers. World’s first human progeria model Scientists from A*STAR’s Institute of Medical Biology (IMB) in Singapore and the University of Hong Kong’s Department of Medicine have produced the world’s first human cell model of progeria, a disease resulting in severe premature aging in one in four-to-eight million children worldwide. This model has allowed them to make new discoveries concerning the mechanism by which progeria works. Hutchinson-Gilford Progeria Syndrome, also known as progeria, is caused by a mutation in the gene encoding for the protein lamin A, an important component of the membrane surrounding a cell’s nucleus. The mutation results in a truncated form of lamin A called progerin, which in turn causes misshapen cell nuclei and DNA damage. Children with progeria suffer symptoms of premature aging, including growth retardation, baldness, and atherosclerosis (hardened arteries), and all die in their early teens from either heart attack or stroke. Led by IMB’s Professors Alan Colman and Colin Stewart, the team used a novel technique of deriving induced pluripotent stem (iPS) cells from cells of human progeria patients. This human progeria model allows the group to trace and analyze the distinctive characteristics of progeria as it progresses in human cells. CEL-SCI starts ph III cancer trial Virginia-based US pharma company CEL-SCI Corporation has commenced its phase III clinical trial for Multikine, the company’s flagship immunotherapy. CEL-SCI has now completed all of the manufacturing and regulatory requirements to begin enrollment of the study. The goal of this study is to establish Multikine as a first-line standard-of-care therapy in treating newly diagnosed head and neck cancer patients. The trial is believed to be the largest head and neck cancer study ever conducted and is called Immunotherapy Multikine Anti Tumor Treatments (IT-MATTERS). The company expects to enroll approximately 880 patients at about 48 clinical centers in nine countries (US, Canada, Hungary, Poland, Ukraine, Russia, India, Israel and Taiwan) in the IT-MATTERS trial. CEL-SCI partners Teva Pharmaceuticals and Orient Europharma will conduct parts of the phase III study in Israel and Taiwan respectively. All study sites, including those in Israel and Taiwan, are under the control of CEL-SCI’s global clinical research organization. CEL-SCI’s phase III clinical trial is an open-label, randomized, controlled, multi-center study designed to determine if multikine administered prior to current standard-of-care used for the treatment for naive subjects with advanced primary squamous cell carcinoma of the oral cavity will result in an increased overall rate of survival versus the subjects treated with standard-of-care only. It will also be the first trial in which immunotherapy will be administered before any other traditional means of care are attempted. Cancer Research, AstraZeneca collaborate to treat cancer Cancer Research UK’s drug development office (DDO) has signed a strategic combinations alliance with AstraZeneca, a global player in pharmaceuticals, to take combinations of experimental cancer drugs into early phase clinical trials. This will increase patient access to trials of potential new cancer treatments that combine molecularly targeted experimental drugs developed and owned by AstraZeneca. The trials will also test these combinations alongside conventional chemotherapy, radiotherapy and other novel agents. It is hoped that combination therapy using a number of molecularly targeted drugs may decrease the chance of patients developing resistance to any individual drug. This is because different types of drugs attack the faults in cancer cells at different points. The trials will be managed by the Cancer Research UK/ UK Health Departments Experimental Cancer Medicine Center (ECMC) Network at hospitals across the UK with support from Cancer Research UK’s DDO. AstraZeneca will provide access to its drugs to be trialled through the alliance as well as additional financial support. The charity will also hold workshops with the ECMC Network and AstraZeneca to identify promising combinations of experimental treatments to trial. Ms Kate Miller, head of the combinations alliance at Cancer Research UK’s DDO, said, “We are delighted to be collaborating with AstraZeneca through the combinations alliance. This initiative will provide a boost to the UK research community in developing exciting new combination therapies and will mean that more UK patients will be able to take part in important clinical trials of potential new treatments.” Prof Andrew Hughes, vice president, Oncology Clinical Innovative Medicines, AstraZeneca, said, “As we further understand the heterogeneity of cancer, we not only need to redefine the disease but also our solutions to it with the ultimate aim of restoring patients’ lives. The collaboration with Cancer Research UK and the ECMCs provides a key opportunity to redefining our solutions to cancer through combination treatments.” Cancer Research UK and the ECMC Network have established clear processes to run early phase combination clinical trials through the ECMC Network. This includes peer-review of the scientific data and trial endorsement through Cancer Research UK’s New Agent’s Committee. Researchers find ways to attack breast cancer Scientists at the University of Michigan Comprehensive Cancer Center, US, have identified a potential new way of attacking breast cancer stem cells, the small number of cells in a tumor that fuel its growth. Researchers found that breast cancer stem cells are regulated by a type of cell derived from bone marrow, called mesenchymal stem cells. These cells are drawn from the bone marrow to the cancer and create a ‘niche’ for the cancer stem cells, allowing them to replicate. “The findings of the research help to find ways to attack breast cancer stem cells indirectly by blocking these signals from the niche,” said study author Mr Max S Wicha, distinguished professor of oncology and director of the University of Michigan Comprehensive Cancer Center. Breast cancer stem cells were first identified by Mr Wicha and colleagues at the University of Michigan in 2003. Cancer stem cells are believed to be resistant to current chemotherapies and radiation treatment, which researchers say may be the reason for the reappearance of cancer after treatment. Little is known about the cancer stem cell niche – a type of microenvironment that is highly associated with tumor growth and metastasis. The researchers looked at mesenchymal stem cells, which arise in bone marrow, and found that breast cancers in mice sent out signals that attracted mesenchymal stem cells from the bone marrow into the tumor where these cells interacted and stimulated the growth of breast cancer stem cells. ]]> <![CDATA[Quintiles opens new facility in Hyderabad]]> https://biospectrumindia.com/news/95/3433/quintiles-opens-new-facility-in-hyderabad.html https://biospectrumindia.com/news/95/3433/quintiles-opens-new-facility-in-hyderabad.html Fri, 04 Feb 2011 11:46:00 +0530 Quintiles, a fully-integrated biopharmaceutical services company offering clinical, commercial, consulting and capital solutions worldwide, has officially opened its new phase I research facility at Apollo Health City, Hyderabad. Constructed in partnership with Apollo Hospitals Group, the new facility will complement Quintiles existing phase I facilities to help customers navigate complex early development challenges and make key decisions. It will provide biopharma customers additional options to complete integrated phase I programs across multiple geographies at this pivotal stage in medical research. Mr Eddie Caffrey, senior vice president and head of phase I research, Quintiles, said, â€œSponsors are under intense pressure to speed-up the delivery of results, ethically, and without compromising patient safety or quality of data. With this new, state-of-the-art, phase I facility in Hyderabad, we will be better able to ally with customers by providing access to large numbers of healthy volunteers for simple studies, in parallel to more complex studies conducted by scientific experts in Europe and the US.â€? The team in Hyderabad will work to global standards and procedures and will be connected to sites in London, Uppsala and Kansas through Quintiles global data network to simplify study management for sponsors and provide integrated information and perspective as early as possible in the development process. The 86-bed unit will evaluate compounds developed both in India and in other countries. Data capture will be linked electronically to Quintiles' phase I units in the UK, the US, and Sweden. Thirty two beds are equipped with technically advanced diagnostic cardiology equipment for TQT studies. Dow, GVK identify lead molecule US-based agricultural company, Dow AgroSciences has identified a new lead molecule in partnership with GVK Biosciences (GVK BIO). This newly identified lead compound has been selected for its ability to address a key product goal in support of Dow AgroSciences' growing agricultural chemicals business. The discovery research agreement with GVK BIO began in May 2008 with the goal of generating novel molecules for synthesis and testing as fungicides and insecticides. The two companies have benefited from the depth of expertise in medicinal chemistry and chemoinformatics at GVK BIO in combination with Dow AgroSciences' agricultural chemical capabilities. â€œWe are very pleased to reach this milestone with GVK BIO under this collaborative discovery alliance. As we will invest in our strong agricultural chemicals business, we are building partnerships with some of the world's best research teams to discover creative new solutions in crop protection,â€? said Dr Daniel R Kittle, vice president of R&D, Dow AgroSciences. â€œThe collaboration validates GVK BIO's ability and leadership in discovery programs and specifically our expertise in agro-chemical research. We are delighted with the outcome of the lead molecule and attribute it to the significant collaborative efforts of the GVK BIO and Dow teams,â€? said Mr Manni Kantipudi, chief executive officer, GVK Biosciences. Ecron Acunova expands India operation Ecron Acunova, a leading CRO with operations in India and Europe, has announced the expansion of Mangalore Clinical Pharmacology Unit to a 80-bed facility. This expansion caters to the growing needs of global clients in pharmacokinetic and pharmacodynamic studies. This takes total bed capacity to 176 units across research centers at Mangalore, Manipal and Bangalore. Drug research at the center involves analyzing the activity of the drug in plasma using spectroscopy. Speaking on the occasion, Dr Pai says, â€œI commend the safe conduct of studies for Indian and global companies, leveraging the scientific and clinical talent of India. It is heartening to note that studies conducted at the center, got FDA approval, leading to launch of drugs for HIV and cancer treatments.â€? Mr DA Prasanna, chairman and managing director, Ecron Acunova, said, â€œIn a short period of five years, over 250 phase I studies and over 70 late phase studies have been conducted, making the company one of the top three amongst nearly 100 CROs in India. The expansion of the facility will help us to serve our clients at a faster pace.â€? ]]> <![CDATA[ICGEB cracks malaria puzzle: Is onto the first viable vaccine]]> https://biospectrumindia.com/news/95/1762/icgeb-cracks-malaria-puzzle-is-onto-the-first-viable-vaccine.html https://biospectrumindia.com/news/95/1762/icgeb-cracks-malaria-puzzle-is-onto-the-first-viable-vaccine.html Fri, 04 Feb 2011 11:44:00 +0530 Dr Chetan E Chitnis, principal investigator at the International Center for Genetic Engineering and Biotechnology (ICGEB) and recipient of the Infosys Award 2010, has cracked the puzzle on understanding the interactions of malarial parasite with its host, leading to the development of the first viable malaria vaccine. Dr Chetan E Chitnis, principal investigator, ICGEB, New Delhi accepts award from Dr Manmohan Singh, the Prime Minister of India After years of intensive research, the research group at ICGEB headed by Dr Chitnis cracked the puzzle on processes involved in invasion of malaria parasite in red blood cells (RBCs) thereby streamlining the development of first viable vaccine against malaria. Dr Chitnis's team is currently working on two vaccines - one for plasmodium falsiparum and the other for plasmodium vivax - both strains are found to be widely prevalent in India. While the vaccine for plasmodium Falsiparum has entered phase I clinical trials, the team is in the process of developing the plasmodium vivax vaccine in large quantities and taking it forward to clinical trials. Speaking exclusively to BioSpectrum, Dr Chitnis says, â€œOur research tries to understand how the malaria parasite invades red blood cells and thereafter the vaccine will look at blocking that process that in turn blocks the disease.â€? If commercialized, these vaccines could be a blessingin disguise for a country like India, whose malaria-afflicted population comprises a share of approximately two-thirds of all confirmed malaria cases in South-East Asia, with five states - Orissa, Chhattisgarh, Madhya Pradesh, Jharkhand and West Bengal â€“ accounting for 60 percent of these cases. Other highly-endemic states are Arunachal Pradesh, Assam, Meghalaya and Tripura. Reports indicate that malaria causes 16,000 to 200,000 deaths every year in India alone. An alumnus from the Indian Institute of Technology, Bombay (IIT-B) with an MSc degree in physics, Dr Chitnis completed his Master of Arts in Physics from Rice University, Houston (post his degree from IIT-B) and PhD in biophysics from the University of California, Berkeley. He was a visiting fellow at the National Institutes of Health, Bethesda and joined ICGEB as a staff research scientist. He is currently a principal investigator with the Malaria Research Group. An international research scholar of Howard Hughes Medical Institute, US and a senior research fellow of the Wellcome Trust, UK, Dr Chitnis was recently awarded with the Infosys Prize 2010 by the Indian Prime Minister, Dr Manmohan Singh, for his pioneering work in understanding the interactions of the malarial parasite and its host, leading to the development of a viable malaria vaccine. Genesis It was Dr Chitnis' stint at the National Institutes of Health (NIH), US, as a post-doctorate scholar in 1991, that led him to begin his research activities in malaria. He joined a research group headed by Dr Louis H Miller. Dr Miller and his team made a breakthrough with the discovery that a malaria parasite (plasmodium vivax), in order to invade the RBCs, binds itself to a protein on the RBC called the duffy protein. The binding process between the parasite and the host takes place through a protein on the former called the duffy-binding protein. Dr Chitnis then decided to pursue his research work on diseases relevant to developing nations. Dr Miller also discovered that those who had duffy positive were more vulnerable to contracting malaria as against those who are duffy negative. â€œIn Africa, most of the people are duffy negative, hence, the malaria incidence is low. In India, most of us are duffy positive hence we are more prone to malaria,â€? adds Chitnis. At NIH, Dr Chitnis primarily looked at identifying the binding region of duffy-binding protein and making antibodies to block further invasion. â€œWe wanted to know which part of the duffy-binding protein to target and what part of the protein is actually involved in that binding interaction,â€? he adds. At that time, the duffy-binding protein was huge in size measuring up to 150 kilo daltons. The team then narrowed it down to 40 kilo daltons. Vaccine Initiatives Subsequently, Dr Chitnis moved back to India and continued his research work. After setting-up his lab at ICGEB, Dr Chitnis further narrowed down the duffy-binding region and also identified the amino acids that were involved in the binding process. â€œWe did a lot of structure function studies on the binding domain,â€? adds Dr Chitnis. The team hence identified the exact binding pocket. â€œThese processes are important because vaccines for malaria parasites is difficult to make due to its variations. If you make a vaccine for one it will not work for another parasite,â€? he adds. These processes were instrumental in the development of the malaria vaccines. Dr Chitnis and team has also developed another vaccine for plasmodium Falsiparum by identifying erythrocyte-binding protein on malarial parasite that binds to the host RBC. This has been a parallel development along with the plasmodium vivax vaccine. Development of the plasmodium falsiparum vaccine was divided into two components. One component-based research work has been conducted by ICGEB's director, Dr Virendra Chauhan and his team, the other component has been developed by Dr Chitnis and team. Subsequently, they mixed the two components and developed the vaccine on the same rationale of antibodies blocking invasion of the parasite and those methods have been transferred to Hyderabad-based Bharat Biotech. â€œVaccine was produced, which then went into toxicology studies and entered phase I clinical trials in Bangalore. The vivax vaccine will also follow the same route,â€? says Dr Chitnis. In terms of infrastructure, Dr Chitnis established a pilot recombinant protein production facility at ICGEB that has been used to develop methods to produce recombinant protein-based malaria vaccines. A legal entity called the Malaria Vaccine Development Program (MVDP), established by ICGEB and funded by the Bill and Melinda Gates Foundation, is looking at the the translational work of this endeavor. â€œWe want to expand our activities on malaria vaccines and take more leads to clinical trials to achieve that you need an entity to manage the translational work. It is more like a small biotech company,â€? adds Dr Chitnis. Future Dr Chitnis is determined to focus his efforts on malaria research. He reveals that there are some avenues opening up in his lab wherein his team is looking at basic problems in invasion of malaria parasite. This opens up vistas in drug development. For the duffy-binding protein, Dr Chitnis' team has identified molecules that help in invasion and subsequently identify signals that trigger secretion/release to the surface. That has opened up a new field of signaling mechanisms during invasion. And that in turn opens up avenues for drug development. Nayantara Som in Mumbai ]]> <![CDATA[NCR:The Nucleus of Research]]> https://biospectrumindia.com/news/95/4061/ncrthe-nucleus-of-research.html https://biospectrumindia.com/news/95/4061/ncrthe-nucleus-of-research.html Fri, 04 Feb 2011 11:43:00 +0530 Home to regulatory authorities, key companies and major institutes, National Capital Region (NCR) is beginning to get its due from the biotech industry In 1962, the Government of India took the decision to create National Capital Region (NCR) with an aim to relieve New Delhi's burden of growing demands from corporate bodies and government establishments. Therefore, the neighboring states such as Rajasthan, Haryana and Uttar Pradesh were considered for developing satellite cities of Gurgaon, Noida, Ghaziabad and Faridabad. However, it took many years to actually implement the infrastructural changes. Now, the biotech industry in the region is emerging from its nascent stage to witness a phenomenal change. Biotech Industry The major attraction of NCR is the presence of national and international research institutions. Institutes such as National institute of Immunology (NII), International Center for Genetic Engineering and Biology (ICGEB), Institute of Genetics and Integrative Biology (IGIB), Indian Agricultural Research Institute (IARI), Jawaharlal Nehru University (JNU), National Plant Genome Research Institute (NPGR), National Research Center for DNA Fingerprinting (NRCDF) provide a great atmosphere for research in various areas of biotechnology. The Department of Biotechnology (DBT) that formulates the policies and strategies for the development of biotech sector in India is based in New Delhi. The region is also home to four key government departments - the Department of Science and Technology (DST), the Ministry of Health and Family Welfare, the Ministry of Agriculture and the Ministry of Environment and Forests - which are involved closely with the growth of biotechnology. Two other important government agencies - the Council of Scientific and Industrial Research (CSIR), which runs a chain of 39 laboratories out of which 12 are dominant players in biotech; and the Indian Council of Agricultural Research (ICAR), with 91 laboratories - are also headquartered in New Delhi. Despite the dominance of government sector, NCR region is now home to major international and domestic biotech, pharma, CROs, medical technology and biosupplier companies. Nearly 25 big and small biotech companies operate in the region. Going by the statistics, in the year 2009-10, the northern biocluster contributed just about one-seventh of the total biotech revenues at $444 million (2,030 crore). NCR is home to the top three companies - Panacea [$154 million (703 crore)], Jubilant [$55 million (249 crore)] and Eli Lily [$41 million (187 crore)] - contributed 56 percent of the revenues from North India. Of the three large companies in the North, Panacea is the only one that grew at 17.86 percent, a growth rate higher than the industry growth rate. In the clinical research industry, Max Neeman International was among the fastest growing CROs in the country. In the biosupplier space, Becton Dickenson was the leading player from the NCR with close to 17 percent of the market share and was followed by Imperial Life Sciences with eight percent market share. The top five players in North, mostly from this region, accounted for 44 percent of the total $291 million (1,329 crore) generated by the companies based in North. The leading industry associations, the Confederation of Indian Industry (CII), the Federation of Indian Chamber of Commerce (FICCI) and the Associated Chambers of Commerce and Industry (ASSOCHAM), based in the New Delhi, have been promoting biotech in a big way since the last five years. CII organizes an annual biotech show and ASSOCHAM has been organizing a Biotechnology Millennium Summit. Besides that, FICCI has been active in promoting the biotech industry by offering platform to interact through various activities. The core industry associations such as Association of Biotechnology Led Enterprises-Agriculture Group (ABLE-AG), All India Biotech Association (AIBA), and Biotech Consortium India Limited (BCIL) are among the leading associations in the region. The recent incentives offered by Haryana government to the biotechnology companies to promote their growth in the region could provide the required impetus. - Dr Ajoy Kumar,CEO, Max Neeman International As a CRO, we feel that the NCR currently offers a very good infrastructure. The presence of government agencies is an added advantage for us. - Mr SK Mukherjee, director, CliniRx NCR is regarded as a biotech commercial hub and as a capital of biosuppliers. Though other cities have some good research institutes, I think research infrastructure is much better in Delhi as compared to Bangalore and Hyderabad. - Mr Neeraj Gupta, director - sales & marketing, Imperial Life Sciences There is definitely the need for government authorities to develop the biotech policy at par with other states such as Karnataka and Maharashtra. - Dr Shrikumar Suryanarayan, CEO, Biotech Cluster, Faridabad There is a need for the government to provide incentives to set-up bioanalytical/analytical service units, state-of-the-art R&D center and training units, BSL2 and BSL3 facilities to handle highly-pathogenic organisms, appropriate experimental animal facilities and facilities for regulatory toxicology for biotech products. - Dr Rajesh Jain, joint managing director, Panacea Biotec Advantage NCR During the last decade, the landscape of this region has been transformed completely with the construction of new skyscrapers, roads and flyovers. Commercial buildings and offices are ever increasing owing to growing demand from foreign and domestic companies. There is better connectivity and improved infrastructure between Delhi and any other satellite cities. This includes the establishment of metro line between Noida and Gurgaon along with the international airport that is located in NCR. â€œThe recent incentives offered by Haryana government to the biotechnology companies to promote their growth in the region could provide the required impetus. Preferential allotment of land to biotech industry, and rebate on land cost to set up industrial unit would help to accelerate biotech industry growth in Haryana,â€? says Dr Ajoy Kumar, CEO, Max Neeman International. Home to major biotech companies, Gurgaon provides the best infrastructure in terms of roads, rented space for companies, uninterrupted housing societies and medical facilities. The Indian arm of global giants such as Genzyme, Biogen Idec, DuPont and Eli Lilly have based their operations in Gurgaon. Besides that a number of start-up biotech ventures such as Ara Healthcare, Life Care Innovations are located in the region. Also, a temporary Translational Health Science and Research Institute (THSTI) lab was recently inaugurated. This will be relocated to the main site at Faridabad in the next three years after the infrastructure is ready. Mr SK Mukherjee, director, CliniRx, Haryana, says, â€œAs a CRO, we feel that the NCR currently offers a very good infrastructure. The presence of government agencies is an added advantage for us.â€? Faridabad is one of the main industrial cities in NCR. New Faridabad is the most preferred destination for industries, IT companies, corporate bodies and government departments. The focus on research institutes is visible in the 200-acre Health Biotech Science Cluster (HBSC) at Faridabad. Being a multi-disciplinary approach to education and research, this biotech cluster comprises of Translational Health Science and Technology Institute (THSTI), regional center for biotechnology (RCB), center for vaccinology, molecular medicine center, center for diagnostics, biotech park, center for health science technology, center for platform technologies, UNESCO center, incubator and a center for animal model for clinical development. Dr Shrikumar Suryanarayan, director general, ABLE, who has been associated with Health Biotech Science Cluster at Faridabad, says, â€œNCR has a huge potential because of the presence of high-quality institutes. But comparatively, a large industrial hub is missing. Within Delhi's small radius, density of institutes is much thicker. The NCR is competitive and offers roads and communications. It lacks large industry but within a short span of time innovative industry will come up. Though the institutes have been there for long time, the translation is slowly coming up.â€? Four constituent sub-regions of NCR Sub-region Districts Total area Percentage of area Haryana Faridabad, Gurgaon, Mewat, Rohtak, Sonepat, Rewari, Jhajjhar, Panipat and Palwal 13,413 sq.km 40% Uttar Pradesh Meerut, Ghaziabad, Gautam Budha Nagar, Bulandshahr, and Baghpat 10,853 sq.km 32% Rajasthan Alwar 7,829 sq.km 23% National Capital territory (NCT) New Delhi 1,483 sq.km 5% Prominent life science companies in NCR Biotech CRO/CRAMS Pharma/Vaccine Biosuppliers Panacea Biotec Max Neeman International Ranbaxy Life Technologies Genzyme Excel Life Sciences Eli Lilly India Agilent Biogen Idec CliniRx MSD India BD Biosciences Jubilant Life Sciences Jubilant Clinisys Baxter India Imperial Life Sciences Nunhems (Bayer Group) Kendle India Kee Pharma RFCL Life Care Innovations Dabur Research Foundation AIMIL Pharma BioRad ARA Healthcare Premas Biotech Indovax Genetix Biotech Asia Ghaziabad also has witnessed vast changes. Since the 2006 Newsweek survey, which put the city on the global map, Ghaziabad has undergone a complete makeover by adding new housing facilities and infrastructure suitable for companies to flourish. Dabur Research Foundation has its base in Ghaziabad. A number of small biosupplier companies too have their presence in the region. Mr Neeraj Gupta, director - sales & marketing, Imperial Life Sciences, says, â€œNCR is regarded as a biotech commercial hub and as a capital of biosuppliers. Though other cities have some good research institutes, I think research infrastructure is much better in Delhi as compared to Bangalore and Hyderabad.â€? The Noida region is being developed as a 'biotechnology corridor' by the Uttar Pradesh government. Many of these, like the Jaypee Institute of Information Technology, Amity Institute of Biotechnology, Bioinformatics Institute of India are also offering bio-informatics courses to hundreds of students every year. The Biotech Park at Chopanki, Bhiwadi (Alwar) initiated by Rajasthan State industrial Development and Investment Corporation (RIICO) is also expected to attract attention of many private players in the area. Need for Improvement A large number of companies are of the opinion that there is need for a makeover in the region as far as the needs and requirements of biotech industry are concerned. Most companies in the region agree that the core issues of skilled manpower and qualified employees require attention. Also, there is an increased need for collaborations between the public and private players. â€œI don't consider NCR as a biotech hub yet. It still has a long way to go as compared to the cities such as Bangalore and Pune. Although the government research infrastructure such as NII, IGIB and AIIMS are located here, participation of private players has not been much,â€? says Mr VK Dubey, MD, BI Biotech. â€œSince NCR is the nucleus of research activities in India, I think that there is a need for having an exclusive scientific park in the region to promote the bioresearch activities,â€? opines Mr SK Mukherjee, director, CliniRx. The lack of vibrant atmosphere conducive for the growth of the industry still seems to be lacking, as compared to other major cities in the country. The authorities need to be more proactive in paying attention to key issues that hinder the progress of the industry in the region. The vested interests of real estate agents and other related factors may not allow the allocation of land to this industry. So, the authorities need to ensure that the prospective companies don't face any hurdles in expansion of business. Another important issue that needs to be addressed is high land cost in and around New Delhi which discourages key pharma players from setting up their R&D centers here. Preferential allotment of land to biotech industry, rebate on land cost to set up industrial unit would help to accelerate biotech industry growth. â€œAllocation of space for the industry along the Faridabad and Gurgaon-Manesar belt is a good initiative by the government. Besides that the corporate benefits and tax incentives are most welcome,â€? says Mr Gupta of Imperial Life Sciences. While agreeing that there is a need for a substantial biotech policy, Dr Shrikumar Suryanarayan says, â€œThere is definitely the need for government authorities here to develop the biotech policy which is at par with other states such as Karnataka and Maharashtra.â€? The agenda should include the improvement of already available infrastructure, an uninterrupted power supply, better internal transportation and reasonable housing facilities for people working in NCR too need attention. Dr Rajeev Soni, CEO, Premas Biotech, says, â€œThis region needs warehouses for chemical and consumable storage, improvement of the infrastructure already available, reasonable housing facilities for people working in NCR, shopping and hospital services need to be added on top of the already existing ones.â€? Outlook The region has all characteristics to reach the top in terms of numbers and revenue. Quick access to the research institutes and regulatory authorities is a plus. If nurtured well, it can become a competitive advantage and help the region emerge as one of the major biotechnology hubs in the country. While being optimistic about the future, Dr Deb Ranjan Bhattacharya, director of Gurgaon-based consulting firm, Trishna Biotech, says, â€œNCR is poised to be the next big region for biotech following Bangalore, Hyderabad and Pune. Developing infrastructure in the area brings growth of biotech industry. We just need to leverage the advantages and create a vibrant atmosphere, which so far has been lacking.â€? Though the region is slowly being recognized for its contribution to the biotech industry, it still has a long way to go. The future growth of NCR depends on the level of attention given by the authorities to fulfill the specific needs of the industry. However, it goes without saying that if the industry in this region is able to leverage the plus points, the region can undoubtedly experience a much better expansion and growth. Rahul Koul in New Delhi ]]> <![CDATA[Mission: Fighting cancer with recombinant proteins]]> https://biospectrumindia.com/news/95/8088/mission-fighting-cancer-with-recombinant-proteins.html https://biospectrumindia.com/news/95/8088/mission-fighting-cancer-with-recombinant-proteins.html Fri, 04 Feb 2011 11:41:00 +0530 ARA Healthcare has utilized the DBT funding to develop and screen three therapeutic proteins to fight cancerous cells. The results can be revolutionary Founded in 2003, ARA Healthcare (ARAHC) is the first-of-its-kind R&D company, developing biologicals and molecular diagnostic services. The Department of Biotechnology (DBT), had awarded grants-in-aid and loan from Small Business Innovation Research Initiative (SBIRI) to ARAHC for their project entitled 'Product Development, regulatory toxicology and pharmacology and phase I human clinical trial of three recombinant therapeutic proteins (phase I-II)'. While the DBT provided $1 million (`5 crore) of assistance, ARAHC put in another $1 million (`5 crore) for the phase I of the project. ARAHC offers an integrated portfolio of laboratory services, ranging from disease target identification to product development. Their clients are global pharma and biotech companies. The company has 43 employees with an annual turnover of little over half-a-million dollar (`3 crore). The company generates revenue by offering molecular diagnostic services. The objective of the project was to carry out preclinical and phase I clinical development of three recombinant proteins, ARA-I, ARA-II, and ARA-III. While ARA-I is a novel anti-metastatic protein with a potential therapeutic effect in several cancer types; ARA-II is a novel recombinant proapoptotic protein, that selectively targets cancer cells and has wider application in variety of cancer types including cancers of gastrointestine, lung, ovaries, pancreas and gliomas. The third one, ARA-III is a thrombopoietic growth factor. Pharmacological activities, toxicity and side-effect of these three molecules were studied meticulously. Besides, the critical product development and manufacturing process was also studied. The DBT funding came at a time when the company was finding it difficult to get funds from elsewhere. Dr Rama Mukherjee, CEO, ARA Healthcare, says, â€œThe financial assistance from the DBT has been crucial in carrying out the R&D work on these three molecules. The other investments have been primarily made by the promoters and angel investors.â€? Industry Impact: In the last two-and-a-half years, the pharmacological activities of these molecules have been studied extensively. Commercial scale production, purification and formulation processes have been developed and early toxicological studies have also been carried out. As these molecules are non-cytotoxic and have short plasma half-life, tumor shrinkage in the initial phase may not be evident during phase I clinical trial. Consequently, the phase II trial gets complex. â€œEffort are made to raise funds for further trials. As all these three molecules will be valuable addition to current line of therapy in cancer and inflammation, their commercial potentials are high,â€? says Dr Mukherjee. Way Forward: ARAHC has been trying to develop these recombinant proteins further. ARAHC intends to assists its global partners in shortening the cycle and lowering the cost of drug discovery and development by providing cost-effective and efficient co-development and out-licensing solutions. The company is also developing an array of sophisticated and sensitive diagnostic assays for early disease detection and therapy monitoring. Rahul Koul in New Delhi ]]> <![CDATA[Mission: Creating novel tissue engineering techniques]]> https://biospectrumindia.com/news/95/7728/mission-creating-novel-tissue-engineering-techniques.html https://biospectrumindia.com/news/95/7728/mission-creating-novel-tissue-engineering-techniques.html Fri, 04 Feb 2011 11:38:00 +0530 Taking a less treaded path of developing tissue engineering products, ExCel Matrix utilized PPP with NII and DBT to fuel its innovative drive Established in 2004-05, Hyderabad-based ExCel Matrix Biological Devices aimed at commercializing technology developed by its founder scientist and CEO, Dr Aroop Kumar Dutta. Leveraging from various funding schemes of government, the company has been developing innovative technologies to facilitate research in 3D cell culture for regenerative medicine and tissue engineering. These technologies have many applications in research and development, pharmaceutical research and regenerative medicine. ExCel Matrix is the first 'tissue engineering' company in India, and is focused at proprietary technology-based product and commercialization strategies. In 2006, it generated enough data for 'proof-of-concept' to have the attention of Small Business Innovation Research Initiative (SBIRI) of the Department of Biotechnology's (DBT) Apex Committee. The company proved itself promising and was consequently awarded significant funding by SBIRI for its project on novel tissue engineering and 3D cell culture technology. Hitherto, it has received funds amounting $200,000(91 lakh). National Institute of Immunology (NII), New Delhi, that originally developed intellectual property along with ExCel Matrix, is a partner in this project. Dr Dutta has acknowledged the exceptional cooperation that his company has received from the NII, even outside the scope of project without which, he believes, they would not have succeeded in their ambitious target. â€œI believe, lack of such grass-root level public-private partnership have derailed entire projects in the past,â€? says Dr Dutta. Since the company consciously bets on this little understood technology and business, it has not been easy to raise funds like current stem cells-related business modalities. Being an early player in this segment, the company faced difficulties such as lack of mentoring, and unavailability of trained manpower. Besides SBIRI, the company has raised funds from various government agencies like Technopreneur Promotion Program (TePP) of Department of Scientific and Industrial Research (DSIR) to support its R&D and seeking additional support to bring its technologies to market. ExCel Matrix has collaboration with National Institute of Nutrition (NIN), Hyderabad, as well. Way Forward: ExCel Matrix has shown serious commitment towards development of regenerative medicine-based therapeutic products. The company is working towards therapeutic solutions, such as wound healing tissue engineered skin and tissue engineered cartilage. In addition to these commercial targets, the company is exploring the novel applications of ECM Analog technology at research level. Rahul Koul in New Delhi ]]> <![CDATA[PPP: A push for affordable healthcare]]> https://biospectrumindia.com/news/95/1178/ppp-a-push-for-affordable-healthcare.html https://biospectrumindia.com/news/95/1178/ppp-a-push-for-affordable-healthcare.html Fri, 04 Feb 2011 11:36:00 +0530 In the second part of this series that decodes the success of PPPs and its prospects, BioSpectrum showcases three case studies that exemplify the benefits of such partnerships Development of innovative technologies to facilitate research in 3D Cell Culture for Regenerative Medicine and Tissue Engineering by Hyderabad-based ExCel Matrix Biological Devices. Bhubneshwar-based Imgenex India's initiatives on developing drugs against osteoporosis using the applications of nanobiotechnology. New Delhi-based ARA Healthcare's projects to carry out pre-clinical and phase I clinical development of three recombinant proteins, ARA-I, ARA-II, and ARA-III. Mission: Creating novel tissue engineering techniques Mission: Tackling osteoporosis using nanobiotech Mission: Fighting cancer with recombinant ]]> <![CDATA["We're set to launch many new products"]]> https://biospectrumindia.com/news/95/1865/were-set-to-launch-many-new-products.html https://biospectrumindia.com/news/95/1865/were-set-to-launch-many-new-products.html Fri, 04 Feb 2011 11:34:00 +0530 Interview: Mr Karnik Parikh, director Pharmalab, Maharashtra Mumbai-based Pharmalab, is an engineering company that looks at the designing, manu-facturing, installing and commissioning of fabricated stainless steel process and packaging equipments for the Indian pharmaceutical companies. Since its inception in 1962, the company has been operating in the Indian market with constant upgradation, innovation and customization of its products. In 2010, the company ventured into alliances with European companies, thus registering a growth rate of about 20 percent. In an interview with BioSpectrum, Mr Karnik Parikh, director, Pharmalab, throws light on the company’s achievements over the past one year, global initiatives, product launches and future plans. Some excerpts: Q What the major achievements of Pharmalab in the last one year? We manufactured hi-tech freeze dryers in technical collaboration with Serail of France. Serail’s expertise in loading and unloading of vials and bulk products gives comprehensive solution to achieve the latest good manufacturing practice (GMP) standards and meet regulatory requirements. We also brought out a state-of-the-art Aseptic Barrier Technology from SKAN of Switzerland. The isolation technology offered by SKAN is unique with fully-integrated vaporized hydrogen peroxide sanitization facility, built in the system. Pharmalab also tied-up with FILTROX of Switzerland to bring high-tech filtration systems, filter consumables and modules for the Indian biotech, pharma and beverage industry. Manufacturing license for leaf filters is under negotiation. We partnered with Albet Hahnemuhle of Germany to bring laboratory filter papers and consumables to the Indian market. This allowed us to find markets in Europe and South American countries apart from Asian markets. Our collaboration with Sterichem TBM of France was to manufacture Ethylene Oxide Gas Sterilizers for the medical devices market. All these alliances were possible due to better market demands, innovative methods adopted by Indian pharma and biotech industry and Indian companies were willing to offer indigenously manufactured equipment to counter challenges posed by reputed international manufacturers. Q How favorable has the Indian life sciences market been for the company till date? The Indian life sciences market has been quite favorable for Pharmalab.We have been able to innovate and bring world-class technology to India. We have been able to grow the business at the rate of 15-20 percent barring 2008-09, which was the year of consolidation as most companies held back investment in new projects. Our group revenue for the current year is expected to be about $17 million (`80 crore). Q What has been the performance of the company in the global markets, and what are the new markets the company will focus on in the coming years? Our export revenue growth was 30 percent in the last fiscal. We are now exporting to almost 35 countries including European markets. Turkey, Syria, Iran, Mexico, UAE, Kenya and Nigeria are also some of the growth markets. We also export to our collaborators Serail and Sterichem in France. We always look for new markets for growth. Our focus would now be towards South American markets of Chile, Brazil, Argentina and Mexico. North African countries like Tunisia and Algeria are also on our agenda. Q What are the new product launches in the pipeline, and what will be the Indian market share? We intend to launch many new products in the coming fiscal that include TOC measuring device, range of hospital equipment, magnetic mixers of latest standards, bag filtration systems, steam quality testing devi-ces and ETO sterilizers for medical devices market. Q Are there any plans to venture into alliances and what criteria do you use for striking an alliance? We already have many alliances mostly with European companies. We are planning to form alliances with Metenova of Sweden for magnetic mixers and Letzner of Germany for water purification systems and TOC measuring devices. We always look for a partner who can add value to our operations in terms of technology transfer and market support. Q What are the expansion plans and revenue target for Pharmalab in the next fiscal? We have four manufacturing plants within the group and we are constantly upgrading and manufacturing processes. Introducing new welding, polishing and testing equipments are planned for next fiscal. We are expecting a growth of 20 percent in the next fiscal with export growing at 30 percent. Nayantara Som in Mumbai ]]> <![CDATA["We are ready to create public awareness on technology"]]> https://biospectrumindia.com/news/95/1692/we-are-ready-to-create-public-awareness-on-technology.html https://biospectrumindia.com/news/95/1692/we-are-ready-to-create-public-awareness-on-technology.html Fri, 04 Feb 2011 11:31:00 +0530 Dr Shanthu Shantharam, executive director, ABLE-AG, New Delhi The Association of Biotech Led Enterprises â€“ Agriculture Group (ABLE-AG ), is a group of agricultural biotech companies in India that uses innovative technology to strengthen agriculture sector. The mandate of ABLE-AG is to promote the agribiotech sector in India at all levels. As an influential association, ABLE-AG plays a vital role in the development of appropriate policy environment and influences public perception on technology. In an exclusive interview with BioSpectrum, Dr Shanthu Shantharam, executive director, ABLE-AG, talks about the controversy surrounding Bt brinjal in India, and clarifies some of the deliberately created urban myths about the use of genetic engineering technology in crops. Q What are your views on the controversy surrounding the moratorium on Bt brinjal? Dr Shantharam: My biggest concern is that the whole Bt technology has been completely politicized. Because of the controversy there is an uncertainty on the future commercialization of biotech-based goods and services in India. It is really unfortunate that Bt brinjal became a victim of the ideologically motivated political campaign. The scientific knowledge, the empirical data from the field and the credible global scientific expertise have been neglected. It is no longer a fight on the safety of technology. It has become a battle of political ideologies of different groups on how agricultural development should take place. Some people claim to represent the 'public' or 'farmers' would like to shape this country's agriculture future by going back to old forms of agriculture. It is clearly conflict of ideology driven by activism of all sorts. Some activists and non-governmental organizations (NGOs) allege that most of the Western science and technology developments are ill-suited to ancient culture and civilization like that of India. The opponents are well-organized and have been very successful in changing the minds of people to bring down GM technology. On the other hand, the people who support the technology, are not doing enough to counter this propaganda of vilification, misinformation and disinformation campaign against the technology. It is heartening that India's scientific academies have finally spoken and endorsed the use of genetically modified (GM) technology. This moratorium on Bt brinjal was purely a political decision. The ministers' office was flooded with thousands of faxes and e-mails through an orchestrated campaign to stop this technology as it is a food product. They wanted the minister to be extra careful before approving it. GEAC did not do any good to itself by deferring the matter to the minister. GEAC is a statutorily appointed committee, and it is in the Ministry of Environment and Forests. When we say 'statutorily appointed committee' it means that it is the highest legal authority, and is almost like a court. Its members are like judges. When the judges give their verdict, it is supposed to be final. But, it can be challenged in a higher court (not in a higher bureaucracy). Now that GEAC has been rechristened as the Genetically Engineering Appraisal Committee, which means all future decisions will be made by a political authority, which does not bode well for technology development in the country. What is required now is to commandeer the best possible scientific expertise available in the country, and decide on lifting the moratorium. Q Why was brinjal chosen as a crop of interest? Dr Shantharam: Bt technology can be used in other crops such as tomato and potato, and in fact there are many crops in the pipeline. The reason for selecting brinjal is that it is grown on 55,000 hectares of land in India, and high amount of pesticide is used to control the fruit and shoot borer, the dreaded insect pest of brinjal. In addition, no other insect control technology other than chemical insecticide sprays can control this insect pest as there is no natural resistance known in the entire germplasm of brinjals. Another reason is that it is relatively very amenable to genetic transformation techniques. Q Is there any need for labeling Bt crops when it is available in the market? Dr Shantharam: It is very difficult to maintain market segregation of Bt from non-Bt. Rules and regulations can work when there is a mechanism to implement them. In the Indian supply chain and market place, there is no way of implementing this. A Bt brinjal and a non-Bt brinjal looks the same. A labeled Bt brinjal may not be a guarantee that it is a Bt brinjal, and the reverse is also true. Starting from the farm to dining table, the entire chain has to be changed to maintain 'true' labeling. Non-labeled brinjal may turn out to be Bt brinjal. This is the nature of the problem. The cost will go up if you segregate the two. Even in a sophisticated market system like the US, one cannot maintain segregation. When regulatory agencies have declared it safe, there is no need to label GM crops. The inability of the current market system to maintain segregation should not be used as a reason to avoid growing GM crops in the country. Q How can biotech industry and ABLE help in changing public perception on Bt brinjal? Dr Shantharam: As ABLE is the industry organization, our major goal is to promote agribiotech sector.We strongly promote and participate in public-private partnership and collaborations to promote technology development. We have major responsibility to clear the misconceptions about modern biotechnology. We are trying our best to counter the false propaganda against the technology by reaching out to administrators, policy-makers, politicians, and the public at large. The point is that why would we want to unleash a technology that is inherently unsafe and we will be exposed to its bad effects too. This industry too has a sense of corporate social responsibility to bring only safe and utilitarian products of technology to the market place. We would like to form a networking relationship with scientific community to make stakeholders realize the advantages of GM technology. But, in the meanwhile, we cannot also wait for the entire public perception to change. We, as an industry, need to survive and for that, we are ready to work with any stakeholder to create public awareness and education about the technology. So far, no substantial efforts were taken to uplift agriculture in the country. To strengthen the agriculture sector that employs 70 percent of Indian population efforts need to be done at war footing. Government needs to make big investments for infrastructure development in agriculture. As an industry, we would like to work with the government to develop conducive investment policies. We are living in global world but there are still people who oppose direct foreign investment in this sector. But, we need to understand that this sector like others cannot grow without foreign investment, collaborations and technology partnerships. Rahul Koul in New Delhi ]]> <![CDATA["C-CAMP focuses on developing high-end technologies"]]> https://biospectrumindia.com/news/95/1900/c-camp-focuses-on-developing-high-end-technologies.html https://biospectrumindia.com/news/95/1900/c-camp-focuses-on-developing-high-end-technologies.html Fri, 04 Feb 2011 11:29:00 +0530 Dr Taslimarif Saiyed, director & COO, C-CAMP, Bangalore The Center for Cellular and Molecular Platforms (C-CAMP), a Department of Biotechnology, Government of India initiative, is part of the Bangalore Bio-Cluster that functions with the mission to enhance bioscience research and entrepreneurship by providing research, infrastructure, training and services on state-of-the-art technology platforms. C-CAMP, National Center for Biological Sciences (NCBS) and the Institute for Stem Cell Biology and Regenerative Medicine (inStem) form the Bangalore Bio-Cluster. NCBS, the parent organization, offers a fertile ground for the two new institutes to flourish by providing support and the necessary scientific and administrative infrastructure. These three entities bring together unique individual capabilities and a shared multi-disciplinary approach to create an interactive bioscience and technology research enterprise. It is envisaged that this integrated vision of the cluster will result in cutting-edge scientific discoveries, and the translation of these discoveries into tangible technological development in the broad field of life sciences. In an interview with BioSpectrum, Dr Taslimarif Saiyed, director and COO, Center for Cellular and Molecular Platform, shares the activities and future plans of C-CAMP. Q What are the key activities of C-CAMP? Dr Saiyed: In life science research, high-end technology and tools are becoming key components in executing laboratory experiments. Hence, accessibility to these high-end technologies can determine the success of any scientific laboratory, organization, or community. Additionally, new technologies, depending on the specificity of the technology and other factors, take time to migrate from the place of its origin to its place of application. This means that users in the place of origin access the technology first, however, users in other places only get to use the technology after a certain delay. This can sometimes be years depending on the exclusivity of the technology. Hence, it is very important for a country like India, which is involved in technology creation, to ensure timely access for its scientific community. As a key mandate, C-CAMP is involved in working with scientists, entrepreneurs, biotech start-ups, and pharma companies to establish new high-end technologies in the country. C-CAMP is open to interesting ideas from the potential collaborators and is willing to support these ideas at various levels. The most unique mandate of C-CAMP is to create a group of biotechs in and around the Bangalore Bio-Cluster and support their growth with incubation facilities, services, expertise, and collaboration opportunities. Although this is a more difficult task, it is envisaged that this incubation facility coupled with tailored services and consulting will provide both scientific and non-scientific expertise to an entrepreneur or start-up and allow them to take the individual/firm from an idea to proof of concept and further growth. The non-scientific advice given will include consulting for research and market, due diligence, IP analysis and evaluation, technology transfer, government/ private funding and regulatory affairs. Q Which technology platforms available at C-CAMP? Dr Saiyed: C-CAMP has been providing high-end platform technologies and expertise to academic and industry scientific researchers in numerous core platforms: Confocal and fluorescence microscopy: The central imaging facility provides researchers with access to cutting-edge platform technologies in the imaging space. This range of imaging of equipment is currently not available anywhere in India. Flow cytometry: The facility provides access to high-end flow analyzers and flow sorters to allow high-speed analysis and sorting of cells and organelles. In the near future, we also will have a high-resolution flow sorter to allow efficient sorting of individual chromosomes, a first in India. Molecular characterization and proteomics: The facility provides researchers with state-of-the-art techniques and equipment to characterize biomolecules with an emphasis on proteins and peptides. We will soon extend this for large-scale screening, identification and quantitation of proteins from complex biological samples. Transgenic fly facility: The facility offers a world-class microinjection service for the generation of transgenic lines and also, maintains a large number of mutant strains and transgenic lines. High-throughput screening: For drug design studies, molecular interaction studies or for identifying the role of a particular biochemical process, the facility provides researchers with the ability to quickly identify active compounds, antibodies or genes that modulate a particular biochemical pathway. RNAi-based screens and chemistry-based screens as well as combinations of these are in the process of being set-up at C-CAMP. Intellectual property management office and technology transfer office: Allow researchers from the Bangalore Bio-cluster to realize the commercial potential of their exciting inventions and innovative research. The IPMO and TTO work with BBC researchers and scientists to protect their IP and commercialize new technologies in collaboration with and through our legal, industrial and commercial partners. Additionally, C-CAMP is providing IP/patenting advice to other notable institutes in India. The TTO has developed a catalog of innovations coming out of NCBS, which can be used as a tool to attract potential licensees, investors and research partners and thus be able to explore exciting commercialization avenues. In addition of providing platform technologies, C-CAMP is providing technology training programs to generate a pool of experts who can proficiently utilize high-end scientific technologies available in scientific organizations and hence, helps in scientific developments. Q Could you elaborate on the future plans of C-CAMP? Dr Saiyed: C-CAMP will focus on the development of new high-end technologies and scientific research through multi-disciplinary collaborations. This include next-generation sequencing (genomics) and protein core facility. Additionally, for continuous growth of technology expertise in the country we will provide nation-wide comprehensive training programs with eminent faculty and the latest instruments in the market. Gradual investment in our human resource stocks will enable us to enhance our technical and management expertise in the area of life sciences. With this enhancement, it is envisaged that C-CAMP will become a life science industry leader in technology platform development and services. We aim to become a unique platform for all scientific researchers to come and discuss their needs, objectives and plans in terms of their research and science. Narayan Kulkarni in Bangalore ]]> <![CDATA[The impact of gene therapy]]> https://biospectrumindia.com/news/95/6174/the-impact-of-gene-therapy.html https://biospectrumindia.com/news/95/6174/the-impact-of-gene-therapy.html Fri, 04 Feb 2011 11:28:00 +0530 Mr Ganesh Sambasivam,Founder & CSO, Anthem Biosciences After completing a short stint of post-doctoral work at NCL, Dr Ganesh Sambasivam joined Syngene (Biocon Group Company) in 1994 at its inception. There he rose to be VP and CSO in a span of 12 years and built a good cohesive group of 500 chemists with diverse chemistry skills. In August 2006, he moved-on and founded Anthem Biosciences, along with two ex-colleagues from Syngene. Worldwide experts are of the opinion that gene therapy's current status is similar to that of monoclonal antibodies 15 years ago and that the net market worth is estimated to be over $20 billion. The world's first commercialized gene therapy drug is Gendicine made by China's Shenzhen SiBiono Gene Tech. Gendicine is now being reviewed by the Drugs Controller General of India (DCGI) to decide on allowing clinical trials in India. Known as Recombinant Ad-p53 Anti-cancer injection this drug is used to treat head and neck squamous cell carcinoma. Data from Indian clinical trials could help significantly in obtaining regulatory approvals in other developing and developed nations. The only other commercialized gene therapy product is Rexin G from Epeius Biotechnologies in California, currently approved for use only in the Philippines for treatment of metastatic breast cancer, pancreatic cancer, osteosarcoma and soft tissue sarcoma. HGF DNA plasmid, a drug from Sosei and Daiichi Sankyo investigated for treatment of peripheral vascular disease was filed for approval in Japan. Success in discrete medical trials has also been witnessed in treating conditions like myelination disorder X-linked ALD (adenoleukodystrophy), ADA-SCID (adenosine deaminase deficiency-related Severe Combined Immunodeficiency) and Leber congenital amaurosis). Although gene therapy failed to live up to its promise in early 1990s, it was generally accepted that the discouraging outcome was not due to an adequate insights into the genomics involved rather due to the lack of an optimal gene delivery system. Success in gene therapy has now been acknowledged as an outcome determined by optimal gene delivery systems. Retroviral vectors have long been used in gene therapy clinical trials. However, this system suffers from serious setbacks such as weak titers and inefficient encapsidation of the therapeutic gene, thus decreasing their therapeutic value. Unlike retroviruses, lentivectors do not necessarily require cell division for proviral integration. Lentivectors couple the advantage of facilitating a highly efficient and stable transgene expression to its ability to transduce a variety of cell types that are not amenable to transduction by other vectors. Anthem Biosciences, Bangalore, a prominent CRO, has widely used the Lentivector system to develop stable engineered cells lines for protein expression as well as for gene knockdown. Possibly, the first Indian company to use this system for engineering mammalian cells, Anthem has validated several engineered cell lines that serves as the launching pad for the various cell-based platforms intended to facilitate high-throughput screening of chemical entities targeting specific disease conditions. This has provided a shot in the arm for Anthem's gene therapy program currently in the pipeline. Although several clinical trials are currently on in several parts of the world, gene therapy still appears to be in the infancy stage in India. Studies are however being conducted for oral cancer at the Tata Memorial Hospital, Mumbai. Narayana Nethralaya, a speciality eye hospital in Bangalore is in the process of using gene therapy to treat Inherited retinal disorders in children. Although a recent Financial Express report indicates that Intas Pharma will launch Gendicine in India, there appear to be no reports of any company in India that has taken the initiative to invest in and explore the potential of this remarkable technology in improving the quality of health care in India. In this regard, Anthem Biosciences aims to exploit its significant expertise in genetic engineering to design and implement gene therapy strategies that could potentially prove to be a boon to the millions that suffer from genetic disorders. ]]> <![CDATA[Next gen innovation strategy]]> https://biospectrumindia.com/news/95/5306/next-gen-innovation-strategy.html https://biospectrumindia.com/news/95/5306/next-gen-innovation-strategy.html Fri, 04 Feb 2011 11:25:00 +0530 Dr Janakiraman RamachandranChairman & CEO Gangagen Inc Dr Ramachandran is an experienced executive who has led multiple successful enterprises. His previous assignments include being the head of the R&D team at Neurex Corporation, Menlo Park, CA that developed an innovative treatment for intractable pain. He has also served as R&D head of AstraZeneca, Bangalore, establishing the state-of-the art R&D programs for discovering and developing novel therapies for the treatment of tuberculosis and antibiotic resistant infection. He has been on the faculty of the University of California, San Francisco for 16 years and is a member of the Indian Academy of Sciences. Despite the high expectations generated by the genomics-based drug target discovery strategies in the late 90s, pharmaceutical R&D productivity has declined in the last decade. There are many influences that have contributed to this decline even while R&D investment has continued to rise. Only one out of 5,000 compounds from the discovery stage makes it to the market. Only one out of five products in phase I is successful and there is a 50 percent failure even for compounds in phase III. The main reason for this low conversion of discovery to approved products is the neglect of the science of development. There is clearly a need to appreciate that drug development requires as much innovation as discovery, and improvement in pharmaceutical productivity can come only through strong integration of discovery and development. Pharmaceutical development requires good problem-solving skills for overcoming the numerous hurdles a potential drug candidate encounters in the preclinical development pathway. These skills are not taught in any academic programs and those who acquire these competencies on the job are often not sufficiently appreciated and rewarded. This imbalance in the recognition and appreciation accorded to discovery compared to development needs to be addressed if the biopharma industry wants to increase productivity. In terms of innovation, novel products can also be discovered and developed by addressing the limitations and side effects of existing older drugs through the application of modern technologies that were not available when those drugs were originally developed. GangaGen has employed this strategy successfully to develop novel therapeutics for the control of antibiotic-resistant bacterial infection. The global resurgence of antibiotic-resistant pathogens and the significant decline in the development of novel anti-infectives has led to renewed interest in bacteriophage-based therapies in view of the successful use of phages prior to the discovery of Penicillin. Phages were shown to be highly effective in controlling epidemics of Shigella dysentery in France by Felix d'Herelle and the Cholera Phage Enquiry in the Assam province in India from 1928â€“1935 demonstrated that mortality from cholera could be drastically reduced through judicious use of phage. Although phages had proved efficacious, their development was abandoned due to perceived and real limitations, namely, the immune response to phages, rapid release of toxins due to the lytic actions of phages (e.g., endotoxins), the potential for transfer of toxin genes from pathogens to avirulent organisms, difficulty in dose determination in clinical situations due to the exponential propagation of phages, and the lack of broad patent protection. These deficiencies have recently been rectified by the use of genetic engineering of phages to generate novel recombinant phages, incapacitated whole cell vaccines and phage components that are highly effective against antibiotic-resistant pathogens. Starting from products containing natural phages that are useful for controlling Methicillin Resistant Staphylococcus Aureus (MRSA) which are therapeutic products with low intellectual property rights (IPR), GangaGen has developed proprietary Lysis-deficient phages, incapacitated whole cell vaccines produced by the use of Lysis-deficient phages, phage entities without DNA (phage tails) and recombinant phage proteins that retain the exquisite specificity of the phage without the attendant limitations referred to above. A key feature that was essential for the successful development of these products was the close integration of R&D teams into a cohesive unit that focused on solving problems efficiently and rapidly. ]]> <![CDATA[Cell therapy vs drugs]]> https://biospectrumindia.com/news/95/8335/cell-therapy-vs-drugs.html https://biospectrumindia.com/news/95/8335/cell-therapy-vs-drugs.html Fri, 04 Feb 2011 11:24:00 +0530 Dr Samuel JK Abraham,Director, Nichi-In Centre for Regenerative Medicine Dr Abraham started research in stem cells besides clinical cardiac surgery work with institutes in Japan under the Nichi-In consortium, Tokyo, Japan in 2000, which started the Nichi-In Centre for Regenerative Medicine (NCRM) in India (2005) and helped establish centers overseas through technological collaboration. He is also technical advisor to Niscell and Vision Tec in Malaysia. Primarily, he is with the Division of pediatric cardiac surgery, Yamanashi University-Faculty of Medicine, Japan. He is also the visiting professor at the Dr MGR Medical University in Tamil Nadu. Diseases can be basically congenital or acquired. Among the acquired diseases, those acquired due to invasion by foreign organisms such as bacteria and viruses have been dealt greatly by drugs, which are chemical compounds that act to either curtail or totally destroy the pathogens. However in case of cellular dysfunctions which occur due to altered cellular function(s) or its environment due to physical or other damages which are multifactorial, the management-approach has to be multipronged. Drug vs cell therapy If I take spinal cord injury as an example, where a physical damage to the spinal cord leads to neural and vascular compromise, resulting in damage to the spinal cord leading to paraplegia, its repair using stem cells act through multiple mechanisms such as (i) paracrine action; i.e., secretion of neurotrophic factors that activates the neural orvascular cells in the damaged area to form new cells, (ii) trans-differentiation of the stem cells into neural cells and (iii) fusion of the stem cells to form new neural cells, which is a multipronged approach. The stem cells injected in the area of damage, produce neurotrophic factors, transdifferentiate or undergo fusion depending upon the signals in the â€œnicheâ€?. All these occur if there is an adequate blood supply available for the cells to survive, the signals are appropriate for their optimal action and the quantity of stem cells applied is proportional to the extent of the damage. In contrast, a drug, which is a chemical compound such as a neurotrophic factor, will yield a particular concentration of the factor at the given site, irrelevant to whether the factor is necessary, or the dosage is appropriate or whether signals in the niche are appropriate to accomplish the repair or whether the other cascade of activities that help in the mechanism of repair are intact. Therefore, I shall say that in these kind of multi-pronged reparative process, a cell-based therapy would be ideal as â€œcell is a wholesome wonderâ€? which can act appropriately to the need of the environment but a drug will be a â€œsingle-point-acting catalystâ€?, which of course can provide support to the cell-based therapies wherever necessary within their limitations. The chemical compound derived drug-based approach has its own advantages and limitations with adverse reactions and the cell-based therapies have their own advantages and limitations too. An ideal approach to treatment of primary organ failure will be the one in which when these two are appropriately combined to produce optimal results. Stem cell and cells: can they be classified as a drug? In my personal opinion, the evolving stem cell-based therapies for primary organ failures should be classified under a separate category of â€œCell-based therapiesâ€? and considered as clinical procedures similar to the cell-based therapies in bone marrow transplants and corneal repairs in practice for more than three decades and the immune cells such as NK cells in use for more than two decades in treating cancer, rather than drugs. Because, the cells vary from drugs in their characteristics depending upon their source, age and culture conditions, act differently based on the â€œnicheâ€? where they are implanted and their actions are more than simply delivering a particular concentration of a chemical compound. Above all, drugs may have a specific anti-dote; whereas cells or stem cells may not have an equivalent to a specific anti-dote which makes them similar to a clinical procedure. ]]> <![CDATA[The stem cell potion]]> https://biospectrumindia.com/news/95/1931/the-stem-cell-potion.html https://biospectrumindia.com/news/95/1931/the-stem-cell-potion.html Fri, 04 Feb 2011 11:21:00 +0530 Dr Chandra Viswanathan,Head, Regenerative Medicine, Reliance Life Sciences (With inputs from Dr Geeta Ravindran, Head of Research, Regenerative Medicine Group, Reliance Life Sciences) Dr Chandra Viswanathan heads the Regenerative Medicine group at Reliance life Sciences. She has over 45 full text publications and has been an invited speaker at several national and international meetings and symposia, in the area of blood banking, stem cell banking, and plasma fractionation. She has an overall experience of about 28 years in this domain. The scope of regenerative medicine extends much beyond the simple paradigm of providing new building-blocks to a failing organ, to processes that dynamically alter the molecular landscape within the tissue via a number of paracrine factors and other multiple potential reparative processes. Even though the feasibility and safety of stem cell use has been reasonably established, the superior efficacy of stem cell therapy is yet to be proven. It was after 1998, with the discovery of human embryonic stem cells [hES] the concept of using stem cells as potential therapeutics for solid organ disease gained widespread appeal. Due to the ethical issues involved regarding harvest of hES, the propensity for uncontrolled growth in vivo and the likely rejection upon differentiation, clinical focus shifted to the adult-derived phenotypes. The advent of bio-engineered pluripotent stem cells from adult somatic tissues has revolutionized the potential availability and applicability of personalized stem cells. The bioengineered platform has the potential to bypass the ethical and allogenic limitation of hES and allows patient derived tissue to be reprogrammed back to the embryonic phenotype and the opportunity to utilize the 'autologous' approach. As newer sources of pluripotent cells provide the capacity to achieve specified tissue differentiation from all three germinal layers, newer enabling technologies will probably be a stepping stone to maximize repair potency and has now ignited renewed clinical interest. Further, ipre-clinical studies in disease models have demonstrated universal benefit following delivery of a diverse repertoire of stem cell phenotypes, despite a huge variation in dosage, the timing and site of delivery. Such proof-of-principle opens avenues for future optimization of this novel stem cell platform for translation into clinical practice in addition to being a model for drug discovery and development. This transition from a stable stem cell phenotype into reproducible and efficacious products involves extensive process validation; robust quality systems and a strong package of in vitro and preclinical data. None of these are cheap and the challenge lies with us to deliver a new generation of cost effective and efficacious therapeutic solutions. Genomic and proteomic evaluation of adult stem cells will throw more light on the small molecule development for the future, help in companion diagnostics, and make theranostics very significant. Such approaches would move naÃ¯ve â€œfirst generationâ€? stem cells from achieving a specific limited therapeutic objective to another level of understanding delivery, evaluation of the risks and benefits of repeat therapy and use of well characterized, lineage specified stem cells, transplanted either alone or in combination, which will mark the beginning of â€œsecond generationâ€? therapeutics. With a cohesive government initiative and appropriate funding, within 20 years, regenerative medicine will be the standard-of-care for replacing all tissue/organ systems in the body, in addition to its extensive industrial use for pharmaceutical testing. In the next two decades, we also hope to achieve major milestones starting with insurance reimbursable regenerative therapies, and establishment of standards for the regulatory approvals. We also expect that the world will engineer smart degradable biocompatible scaffolding and develop micro-fabrication and nanofabrication technologies to produce tissues with their own complete vascular circulation, producing an in vitro sophisticated 3-D tissue and organ models that cannot be ordinarily regenerated through routine in vivo techniques. Just as discovery and usage of penicillin was the inflection point in the fight against infectious diseases, application of stem cell-based therapies will be the turning point in the treatment of hitherto inadequately treated or incurable diseases of the twentieth century. ]]> <![CDATA[A time to imagine and dare]]> https://biospectrumindia.com/news/95/1619/a-time-to-imagine-and-dare.html https://biospectrumindia.com/news/95/1619/a-time-to-imagine-and-dare.html Fri, 04 Feb 2011 11:19:00 +0530 Dr Arumugam Muruganandam,Chief Scientific Manager Research & Development Biocon Dr Arumugam Muruganandam leads the preclinical group, and immunogenicity and biomarker development team at Biocon in Bangalore. He is a protein biochemist and cell biologist with over 20 years of experience in academic, government and corporate research environments in Canada, US and India. As the number of drug-able targets are limited to protein products of 30,000 odd human genes, many traditional pharmaceutical industries with expertise in discovery of broad spectrum inhibitors to these targets are looking to exploit modern biotechnology for targeted therapies such as peptides and therapeutic monoclonal antibodies. Instead of building expertise from scratch, many pharma majors have started to become biopharma by acquiring small biotech companies with exciting and innovative therapeutic ideas, collaborate with mid-size biotech companies with novel platform technologies and /or merge with biotech companies which have rich pipeline of products at various stages of development. Unlike major global pharma, Indian pharma industries, transformation into biopharma is through organic growth and mainly by developing similar biologics at much cheaper cost. From the point of discovery of novel molecules there are only few players who endeavor into high-risk long term projects in India. However, in the past few years with rich talent pool of chemist, Indian pharma, biopharma companies and CROs have entered into mode of discovery and development of novel molecules using chemical compound libraries with intention to collaborate with multinational companies for global development. When it comes to biologics, replacement therapeutic drugs such as insulin, growth hormones and enzymes were the first to enter market, however, in the past decade more than 20 therapeutic monoclonal antibodies have been approved for marketing and there are more than 400 under clinical trials. The unprecedented success of blockbuster drugs such as Avastin, Herceptin, Rituxan and Humira has catalyzed the interest of major biopharmas to include in their development pipeline, monoclonal antibodies as well. The success of antibody therapy is attributed to its unique properties such as specificity, high affinity, long half-life and safety. Unlike replacement therapy drugs which were discovered by cloning and expressing the genes for its product and developed as drugs, antibodies were initially developed either by conventional polyclonal and monoclonal approaches and later discovered to be used for therapeutic use. The draw back in developing and discovering therapeutic antibodies using the conventional approach is that they are of animal origin (mouse hybridomas) which leads to problems associated with immunogenicity in humans. Recombinant antibody technologies have overcome the immunogenicity issues by converting the mouse hybridoma antibodies to chimeric or humanized antibody variants. Similar to discovering chemicals by screening compound libraries, human antibodies are being discovered using combinatorial approaches such as phage display technology and later developed as drugs for therapy and diagnosis. In India, in addition to tapping the reagent vessels of chemist for source of drugs, there is scope and opportunities for scientist to make a paradigm shift to discover therapeutic drugs using state-of-the art display technologies such as phage and yeast display for antibodies and peptides. Antibody and peptide display technologies unleash new opportunities for drug discovery for immunotherapy, as well for diagnosis. In addition, display technologies can also provide opportunities to discover and develop affinity ligands for purification of biologics that are produced using fermentation-based technologies and for removal of enzymes used during upstream and downstream processing of biologics. There are plenty of opportunities for Indian biopharma to exploit the display technologies with the help of their experienced medicinal chemists; to build antibodies and peptide libraries and screen for drugs, affinity ligands and diagnostic reagents. ]]> <![CDATA[GameChangers of the decade]]> https://biospectrumindia.com/news/95/3931/gamechangers-of-the-decade.html https://biospectrumindia.com/news/95/3931/gamechangers-of-the-decade.html Fri, 04 Feb 2011 11:12:00 +0530 Mr Venkat Jasti,chairman & CEO, Suven Life Sciences Mr Venkat Jasti, a post graduate in pharmacy from Andhra University, Visakhapatnam and a registered pharmacist in the state of NY and NJ in the US returned to India in 1989 and has been promoting Suven since then, in the capacity of the company's CEO providing the direction and leadership in developing innovative business models like CRAMS (Contract Research And Manufacturing Services), DDDSS (Drug Discovery & Development Support Services) which led to Collaborative Research Partnership (CRP) in drug discovery with global pharma giants such as Suven's CRP with Eli Lilly in the CNS arena. Some of the game changers in the pharma industry over the next decade may be: Biology: A remarkable leap forward in how well we understand some biological mechanisms, which will lead to new innovations. Biologics: The field of biologics will be exciting because we can apply new science and technology to the development of important new medicines. Personalized Medicine: Personalized medicine will be another area which will unearth a new era of healthcare through improved diagnosis, earlier interventions, more efficient drug development and better medical outcomes. Healthcare reforms, FDA policies and guidelines will have a major impact on drug discovery and development. Biosimilars and NDDS will lead to product life cycle management. Ever greening of patents will be fiercely opposed by developing countries. Blockbuster scenario will be a thing of the past and generics may not the mainstay of the generic companies alone. Evolution of new business models: The industry needs a new approach and new business models will evolve. Finally, the emergence of a major Indian or Chinese drug company with innovation capabilities will be the real game changer. Biology The pharmaceutical industry is moving from a symptomatic relief focus towards a more pathology-based approach where a better understanding of the pathophysiology should help deliver drugs whose targets are directly involved in the causative processes underlying the disease. The impact of biology across the whole process of drug discovery and development, including (i) the identification and validation of new drug targets, (ii) the development of molecular screens to find new candidate drugs, and (iii) the generation of safety data and competences leading to enhanced clinical efficacy and even more vital role in the generation of future therapies. Biologics Biologics may represent about one in every three newly commercialized drugs and will be the most exciting areas of therapeutic medicine in the future. This biology-based drug discovery and development will be a natural complement to the chemistry-based small molecule, transforming pharmaceutical industry into a biopharmaceutical industry. Personalized medicine Personalized healthcare is a broad term for interventions that are targeted to individuals based on their risk in order to provide a more coherent and focused approach to healthcare. Personalized healthcare includes preventive, diagnostic, and therapeutic interventions, with risk defined through genetics as well as clinical and family histories. Personalized medicine goal includes greater effectiveness and efficiency of healthcare delivery as well as improved health outcomes and quality of life. Healthcare reforms With healthcare reforms happening all over the globe, government's role will expand as a customer for medicines, medical devices and services. But the reform laws also have a huge impact on the life sciences industry's other highly influential customers, such as health plans, providers and state governments which will have tremendous cost pressure and intense scrutiny from the governmental agencies. Industry should be prepared to defend prices and invest in product effectiveness. Biosimilars Biosimilars or follow-on biologics are terms used to describe officially-approved subsequent versions of innovator biopharmaceutical products made by a different sponsor following patent and exclusivity expiry on the innovator product. The opportunity in biosimilars is not exactly â€œnewâ€?, but prior rules (and the uncertainty of how the FDA would apply those rules) largely kept this market empty. Now, though, with the Pathway for Biosimilars Act of 2009 and the Patient Protection and Affordable Care Act of 2010, there is more clarity than before and a reasonably clear mandate from the US Congress for the FDA to act more openly and decisive. A well-crafted pathway for the approval of biosimilars will lower costs through increased competition, expand access to lifesaving medicines, protect patient safety and promote further biomedical innovation. NDDS With more drug patent expiries over the next few years, the loss will be an estimated $140 billion by 2016 and big pharma is under intense pressure to replace these losses with new or improved drugs. Against this background, pharmaceutical companies are recognizing that drug delivery technologies are a powerful strategic marketing tool to differentiate products and extend product life cycles, thereby overcoming many marketplace challenges. Ever greening of patents Ever greening of patents refers to increasing the life of the patent or the patent term beyond 20 years to reap the benefits for much longer period of time. One form of ever greening occurs when the original manufacturer stockpiles patent protection by obtaining separate 20-year patents on multiple attributes of a single product. Many of the developing countries are not allowing patent extensions for minor product life cycle changes hence frivolous patent protection is weakening worldwide. All of the current life cycle management games will be short lived. Blockbusters are out The blockbuster business model that underpinned big pharma-success is now irreparably broken. The wave of blockbuster drug patent expiries over the next few years presents an estimated $140 billion opportunity for generics by 2016. Big pharma cannot ignore this threat to their balance sheet, and will likely stem this loss by introducing their own branded generic products or buying into generics and generic companies. Generics will actually become irrelevant when the big pharma marketers lower prices and keep manufacturing even after patent-expiry, hence generics may not rest with generic companies alone. New business models Most Big Pharma companies have traditionally done everything from research and development (R&D) through to commercialization themselves as a Fully Integrated Pharmaceutical company (FIPCO) by spending record amounts and are slowly realizing to the fact that first-in-class, first-in-market is no longer enough and the blockbuster drug approach is a thing of the past. If they are to prosper, they will need to improve their R&D productivity, reduce their costs, tap the potential of the emerging economies and switch from selling medicines to managing outcomes and transform into a Fully Integrated Pharmaceutical Network (FIPNET) company like what Eli Lilly has done. Becoming a FIPNET means leveraging external competencies and network externally. Over the next decade there is likely to emerge two sets of business models, one with focus on marketing and the other with long term commitment in creating novel drugs in other words pharmaceutical companies will eventually specialize in either drug discovery or marketing. Given the lack of therapies for many serious diseases and the mediocre efficacy of many existing drugs, the opportunities are huge and the development of effective treatments will be the only sustainable source of value for the pharmaceutical industry i.e., â€œinnovate or perishâ€?. There are risks in trying to discover new drugs, but the risks of backing away from that commitment are higher. Those who focus on marketing alone may do better in the short term but are doomed to failure eventually. Likely future scenario The next decade will witness the greatest upheaval in the pharmaceutical industry with many changes in drug discovery and development coupled with competitive atmosphere and changes in governmental policies. We may not see a dominant model in terms of size or organizational structure but will see an ecosystem of few large global players with deep scientific resources and many more specialized companies. Globalization of drug innovation will continue. â€œA game changer, almost by definition, comes from a direction we think is unlikely and, for that very reason, we don't guard against or plan for. I think that direction may well be the East, according to Dr Brian D Smith is an author, academic, and advisor in competitive strategy in medical markets. A real game changer for the industry may be the rapid rise of an Indian or Chinese pharmaceutical company with real innovative capabilities and a low-cost model based not only on lower labor costs but on a lean R&D and commercialization model and no one should be surprised to see the emergence of a major Indian or Chinese drug company to be that game changer in drug discovery and development by 2020. ]]> <![CDATA[Span Diagnostics aims for Rs.1000 cr by 2020]]> https://biospectrumindia.com/news/95/2224/span-diagnostics-aims-for-rs-1000-cr-by-2020.html https://biospectrumindia.com/news/95/2224/span-diagnostics-aims-for-rs-1000-cr-by-2020.html Tue, 04 Jan 2011 19:25:00 +0530 The company has plans to diversify its portfolio and focus on international markets “The IVD market in India is growing at a rate of 10-15 percent, which is achievable for any Indian company. But, if a company wants to grow beyond that level, then it should focus on international markets” — Mr Veeral Desai,  managing director of Span Diagnostics, Gujarat The year 2010 has been a successful one for Span Diagnostics, a Gujarat-based diagnostic company that indigenously manufactures and supplies diagnostic reagents, instruments, consumables and kits for clinical pathology laboratories both in India and abroad. The revenues of the company for the FY 2009-10 increased by 18 percent to $18.14 million (81.9 crore) as against $15.4 mn (69.5 cr) in 2008-09. Its profits rose by a whopping 402 percent from $0.24 mn (1.1 cr) in the previous year to $1.19 mn (5.4 cr) in FY 2009-10. To add to its laurels, for the quarter ending September 2010, net profit of the company rose by 304.62 percent to $0.58 mn (2.63 cr) as against $0.14 mn (0.65 cr) during the same quarter last year. Further, sales rose 19.47 percent to $5.84 mn (26.38 cr) from $4.89 mn (22.08 cr) between the same period. It is indeed a commendable feat for the small-sized Indian company operating in a space largely dominated by global players. Consistent Growth Span Diagnostics has come a long way since 1972, when Dr Pradip Desai, a pathologist by profession, decided to establish a start-up company under the name of Desai Laboratories. Dr Desai’s son, Mr Veeral Desai, managing director of Span Diagnostics, says, “At that time clinical laboratories across India were in dire need of diagnostic reagents which were not readily available in the market. Responding to the market need, Dr Pradip Desai started making his own reagents and in the process got to understand the technicalities involved in making good reagents. Subsequently, he started marketing these reagents.” In 1976, the company was rechristened as Span Diagnostics with an emphasis on in-house R&D to develop more and more products. The company, has since then, moved on from strength to strength. It became a private limited company in 1981 and by the end of the 1980s, had set up its own distribution network and manufacturing facility. As early as 1991, it entered the space of lab automation and with expansion plans in view it went in for an IPO in 1994. Mr Veeral Desai, who joined the company in 1991, was the prime catalyst in introducing new technologies into the work processes of the company. This includes implementation of SAP, modernization of the plant, introducing automation, upgrading manufacturing facilities to meet the US Food and Drug Administration standards, among others. With the dawn of the new millennium, Span Diagnostics’ growth chart witnessed a major turning point. Recalls Mr Desai, “The turning point for Span was the restructuring of its business in 2001. That was the only year the company made a loss. The time then demanded more focus on market orientation. After that there was no looking back.” In the same year, the company ventured into international marketing and exports. Since then, Span has maintained a steady growth rate of 17-20 percent, thus, consolidating its position in the market. The top brass of the company attribute the steady growth to careful planning, reviewing and reorganizing the company structure at regular intervals. Strong Performance Commenting on its recent financial performance, Mr Desai says, “High growth rate was experienced because we drastically improved our operations over the past one year through better management, reorganizing marketing activities, reorientation of our infrastructure and changing our product range. Our significant growth in sales has also directly reflected in the bottom line.” Span currently houses three businesses namely – the diagnostic reagent business, the instruments business and exports. Under the diagnostic reagents business division, there are two revenue streams – one from the market and the other from the government. A revenue split of the Span’s business reveals that 10 percent of revenue comes from exports, 17 percent from the instrument business, roughly 30 percent from the government and the remaining from market sales. Span’s products are exported to Africa, Latin America, CIS, South East Asia. By 2012, the company is looking at entering the US markets with few of its products. Another factor for the bottomline growth was the shift in its paradigm from being a mere distributor of products to establishing its own in-house R&D units, manufacturing and selling both in the domestic and overseas markets. This has improved overall margins. Being a partner for government programs in India and to organizations like the UN, has also played a pivotal role in the company’s phenomenal growth. Since the past eight years, the company has been supplying to National programs for AIDS and malaria. Last year, the company achieved tender sales worth 28 crore from the Indian government. Further, more offers are in the pipeline for the coming years. The Indian government, Mr Desai believes, has been proactive not just in the growth of the company, but for the overall growth of the in-vitro diagnostic (IVD) market too. “We are adding more products to our pipeline which in turn can be supplied not just to the Indian government but global programs as well,” adds Mr Desai. This could boost sales revenues of the company in the coming years. Another notable alliance for Span was its joint venture with Japan-based Nihon Kohden Corporation — a Japanese medical electronics giant — to distribute its hematology analyzers in India, a few years ago. By 2008, Span had installed more than 1,000 analyzers and became the number one player in the hematology segment. In 2008, Span and Nihon Kohden announced a joint venture company, Span Nihon Kohden Diagnostics, to manufacture reagents for the hematology analyzer. Ambitious Outlook Looking forward, the management has kept a target of clocking a revenue of $22.15 mn (100 cr) by the end of the fiscal year 2010. “The turnover for the first six months of 2010 has already hit the $10.19 mn (46 cr) mark and I believe we are on the right track. So the remaining $12 mn (54 cr) will be achievable. We are looking at launching some products in the next few months. We are also looking at reorganizing our marketing activities which will improve our supply chain and make improvements in our infrastructure. We have also lined up certain activities for certain critical products which will yield good results,” adds Mr Desai. The company is also looking at modernizing its plant, for which, investment to the tune of $2.65 mn (12 cr) will be made over a period of one-and-a-half-year. Funding will take place mainly from banks. Growth rate for the coming year will continue to range between 17-20 percent, however, after 2011, Span is looking at hitting a growth rate of 25-30 percent. This is due to the launch of a number of products by 2012, along with increase in export sales. Exports will be a major cash cow for the company. The company is now looking at increasing the revenue share of exports from 10-40 percent. The process to establish its base in the US has already been rolled out. This would either be via a distributor or through a suitable acquisition. Also, Span Diagnostics has a contract manufacturing business which till date has not been its prime focus. “From 2011 onwards, we will give stress on contract manufacturing as well. We have already approached a few clients,” elaborates Mr Desai. The management has also chalked out its 2020 plan wherein it is looking at clocking a turnover of over $200 mn (1,000 crore) by 2020. Apart from launching new products, the management is looking at a growth rate in export businesses ranging anywhere between 30-35 percent. Target sales from contract manufacturing will be to the tune of $44.30 mn (200 cr). This apart, Span Diagnostics will also look at diversifying into promising areas such as agribiotech. Nayantara Som in Mumbai ]]> <![CDATA[BioSpectrum honors biotech excellence]]> https://biospectrumindia.com/news/95/2536/biospectrum-honors-biotech-excellence.html https://biospectrumindia.com/news/95/2536/biospectrum-honors-biotech-excellence.html Tue, 04 Jan 2011 19:23:00 +0530 The BioSpectrum India Awards, now in its 8th edition in 2010, is an endeavor to honor the outstanding achievements of the biotech industry captains. var imgarray= new Array(); var loadarray= new Array(); imgarray[0]="http://biospectrumindia.ciol.com/images/content/2011/jan/Yakshagana,-a-2000-year-old.jpg"; imgarray[1]="http://biospectrumindia.ciol.com/images/content/2011/jan/Event Saldanha-receiving-award-in.jpg"; imgarray[2]="http://biospectrumindia.ciol.com/images/content/2011/jan/Event P1014454.jpg"; imgarray[3]="http://biospectrumindia.ciol.com/images/content/2011/jan/Event lead-visual-.jpg"; imgarray[4]="http://biospectrumindia.ciol.com/images/content/2011/jan/Event KK-Narayan-of-Meta-helix-re.jpg"; imgarray[5]="http://biospectrumindia.ciol.com/images/content/2011/jan/Event 6_Aravind-Jannu-BS-awards-S.jpg"; imgarray[6]="http://biospectrumindia.ciol.com/images/content/2011/jan/Event 3_Leadeship.jpg"; imgarray[7]="http://biospectrumindia.ciol.com/images/content/2011/jan/Event 2_Person.jpg"; imgarray[8]="http://biospectrumindia.ciol.com/images/content/2011/jan/Event 1_Life-time-achievement.jpg"; Prev Next var slide; document.onload=setting(); function setting() { slide=document.getElementById('pic'); slide.src=imgarray[0]; } /*create image space in mem*/ for (var j=0; j ]]> <![CDATA[Mycorrhizal intervention to boost agri outcome]]> https://biospectrumindia.com/news/95/4135/mycorrhizal-intervention-to-boost-agri-outcome.html https://biospectrumindia.com/news/95/4135/mycorrhizal-intervention-to-boost-agri-outcome.html Tue, 04 Jan 2011 19:21:00 +0530 The novel Mycorrhizal technology created by Dr Alok Adholeya and his team at The Energy and Resources Institute (TERI) New Delhi has made a significant foray in creating agricultural transformation. In this part of the CSO series BioSpectrum meets up with Dr Alok Adholeya to understand the technology and its applications.  In an agriculture dependent country like India where there are large tracts of barren land, the mycorhizzal technology can change the topography. From the reclamation of abandoned fly ash dumps and dump yards contaminated with chlor alkali sludge to food and fodder crops in saline wastelands organically, this technology has proven to be highly effective. With utilization of this technology at the basic level, agricultural investments can be significantly controlled. Its use in forestry and agricultural activities can reduce chemical load into the system significantly and make the production cost effective. Technology nitty-gritty Mycorrhiza is the only known fungal system categorized as a biofertilizer. It helps the roots to tap soil nutrients, which are otherwise beyond their reach. However, its application is limited owing to constraints related to mass inoculum production. The Centre for Mycorrhizal Research (CMR) at TERI solved the problem by developing mass inoculum production technology for AM (arbuscular mycorrhizal) fungi. Initiated by Dr Alok Adholeya,  in 1991 the project received impetus in 1993—with the funding of around $2 mn (10 crore) from Department of Biotechnology (DBT), India, the technology reached commercialization point in 2000. Since then it continues to be the only such available technology in the world.  This technology has exploited the genetically modified host roots using Agrobacterium rhizogenes, carrying Ri T-DNA plasmid to mass produce viable, healthy, genetically pure, and high quality fungal propagules without any pathogenic contamination under in vitro sterile environment. The CMR Area’s Mycorrhizal organic fertilizers offer sustainable and environment-friendly solutions to most of the cultivated plants and crops. It is said to enhance nutrition and yields upto 25 percent and curtail the chemical fertilizer inputs by 50 percent. Fertilizers are also effective in wasteland reclamation, and offer benefits to agricultural, forestry, horticulture, and bio-diesel plants. Applications abound According to Dr Alok Adholeya, who has led this development the farmers generally use Rhizobium for all the crops while it can be used for around 85 percent of the total crops in India. They are ignorant about the fact that it cannot be used everywhere. With this technology, both the existing and the remaining 15 percent can be covered. Dr Adholeya is the director, Biotechnology & Management of Bioresources Division at the Energy and Resources Institute (TERI) in New Delhi. Dr Adholeya who bets on its cost effectiveness. “This cost effective safe technology on the higher side can save about 30-50 percent per acre in forestry and approximately 25-50 percent per acre in agriculture,” he says. The Mycorrhizal product formulations developed by the CMR according to each type of plant and kind of implementation are tablets, granules, gels, dry spray, seed coating, seed inoculation, root dipping and irrigation system compatible. The wide applications of the technology include the phytostablization which revives soil where pesticide-use frequency is high. It revives disturbed and degraded soil, prevents erosion, prevents removal of top soil and also enables greening of desert areas thanks to reclamation technologies. More than 90 percent of all plants in nature can form a symbiotic association with the Mycorrhiza. Mycorrhizal application to Jatropa was found to speed up the process of flowering and fruiting, and the first yield was after seven months of cultivation. This technique also leads to higher yield (upto 30 percent) and plant biomass. This is an innovative way to manage effluent disposal in the country employing Microbial Remediation Technology (MRT) to reclaim one of the distillery effluent loaded site in Madhya Pradesh. The technology employs Mycorrhiza and a few other useful microbes to restore the greenery of the land. It alleviates the loading of effluent in unit land area, lowers the level of groundwater contamination, and reduces land pollution of adjoining agricultural lands. The CMR has developed the reclamation technology based on Mycorrhiza organo-biofertilizer for fly ash, which is promising enough to metamorphose the 30,000 odd hectares of fly ash dumps in India into huge commercial plantations. Besides that the toxic wastelands created by the alkali-chlor sludge were successfully reclaimed. Industrial value The technology was transferred to many industries and resulted in the development of the commercialized product, which is available to end users. The mass production of Mycorrhiza Biofertilizer catered to Cadila Pharamceuticals, Ahmedabad in December 2000 and to KCP Sugar and Industries Corporation, India, in February 2001. Besides that the improved technology of mass production of Mycorrhiza Biofertilizer was supplied to Cadila in May 2001. Mycorrhiza Consortium Production was done for KCP Sugars and Industries, Andhra Pradesh, in 2005; Magestic Biotech, New Delhi, in 2004, Cosme Pharma, Goa in 2005 and to Sarita Ganga Farms, Ahmedabad in 2006. Also for the reclamation of industry created wastelands, the beneficiaries of the technologies are National Thermal Power Corporation, Tata Chemicals, Fly Ash Mission, TIFAC, Madhya Bharat Papers, Associated Alcohols and Breweries all based in the country. Technology Creator Dr Alok Adholeya got his doctorate from the department of microbiology, G.B Pant, University of Agriculture & Technology, Pantnagar and Jiwaji University, Gwalior, India which he completed in the year 1988. Prior to that, after doing his Master’s in Botany from Jiwaji University in 1984, he worked at Tata Energy Research Institute (TERI), New Delhi for couple of years from August 1986. His research interests include the soil fertility, soil and plant microbiology, nutrient cycling, bioremediation using microbes and plants, mass production of Mycorrhizae biofertilizer using transformed root organ cultures. Dr Adholeya is well versed with mycorrhizal isolation, charactrization (both morphological and molecular), inoculation, colonization assessments and efficiency tests. He also has working experience of soil and plant analysis methodologies. He has a practical experience of field trial evaluation, designing and management, transformation techniques, enzyme assays, Radio tracer techniques and a fair knowledge of statistical analysis of data. Recipient of numerous awards for developing this technology, Dr Adholeya has been a well known name in this field now. He was presented a momento of honor by then Minister of Science & Technology, Dr Murali Manohar Joshi for mycorrhiza technology on in 2000. He also received ‘Paryavaran Sanrakshan Samman’ in the year 1999 by then Chief Minister of Madhya Pradesh, Mr Ajit Jogi. He was awarded by Bhoomi Nirman, Agricultural and Rural Development monthly newspaper for his significant contributions in biotechnological applications in rural areas. He was also honored with  the Best Paper Award on Environmental Applications in the VIIth World Bamboo Congress in February 2004 at New Delhi. But among all of the honors and awards received so far, Dr Adholeya feels proud to have received the honor by Department of Biotechnology, Ministry of Science and technology on Technology Day in 2004. DBT recognized his efforts awarded him with the prestigious “Biotech Product & Process Development and Commercialization Award, 2004” Besides being the chief editor of Mycorrhiza News, Dr Adholeya is a member of editorial boards of many national and international journals. Few of those include the International Mycorrhiza Journal, published by Springer Verleg, Germany, as the only Asian in the editorial board. Swedish Journal of Agriculture, a reputed international journal of Agriculture published by TAYLOR & FRANCIS group. Indian Journal on Micribiology, published by the Association of Microbiologists of India, IARI, India. Biology and Fertility of Soils Journal, published by Springer-Verlag, Germany. Dr Adholeya who has attended 80 conferences and seminars so far, has around 58 publications in international referred journals and 22 publications in national journals. Besides guiding nine PhD students, he has also authored a book on Production and Technology of Biodiseal-Seeding a Change. He has been a visiting faculty of Deakin University, Australia since March 2010. He is the member of numerous expert groups and societies. Such as the World Bank Biofertilizer Programme and Indian Council of Forestry Research and Education. Dr Adholeya is also a member of a large number of expert groups/societies, DBT, Ministry of Science and technology, New Delhi; Member, Inter-disciplinary research committee (IDRC); DBT Member, Program Advisory committee (PAC) for Fly Ash Unit; DST Member, Science and Society; DST Indian Council of Forestry research and Education; Department of Science and Technology, New Delhi; Department of Biotechnology; Indian Council of Agriculture Research; Ministry of Non-Conventional Energy Sources, New Delhi; and Department of Environment, New Delhi. Besides being a part of the World Bank Biofertilizer Programme, Dr Adholeya has been a member of International Foundation for Science, Sweden; Food and Agriculture Organization,Thailand; Technical Advisory Committee of Mycorrhizae Network Asia; Mycological Society of America, New York, USA; British Mycological Society, UK; Society of Biological Editors, USA; Chairman, Task Force-Biofertilizers; Member, Advisory Board, International Risk Governance Council (IRGC) Dr Adholeya who is also on the European Network for Mycorhizzal technology, says “ Europeans have been fast to adopt this technology. India has to gear up and learn a lot from them.” The current research activities in his lab include the evaluation of this technology for the different cropping system in India and worldwide. These include the ones in agriculture, horticulture and forestry, essentially the crops such as sugarcane, wheat, various vegetables, pomegranate and jatropa. The continuous efforts are on to better this technology. How it can be utilized for different purposes is being evaluated. In the words of Dr Adholeya, “My mission is to make the end user happy and the vision is to develop this technology towards offering the one stop-solution to the farmer.” Rahul Koul in New Delhi ]]> <![CDATA[MNCs up direct presence]]> https://biospectrumindia.com/news/95/2869/mncs-up-direct-presence.html https://biospectrumindia.com/news/95/2869/mncs-up-direct-presence.html Tue, 04 Jan 2011 19:20:00 +0530 India is now witnessing acquisitions in the biosuppliers space. In the two recent deals, US companies have acquired major Indian suppliers with an aim to strengthen their direct presence in the country In November 2010, US-based Avantor Performance Materials decided to acquire New Delhi-based biosupplier company, RFCL Limited. The acquisition, to be completed by the end of January 2011, is expected to further boost the product and service offerings of Avantor. The deal comes after ICICI Venture sold its 85 percent stake in RFCL to Avantor. In 2005, ICICI Venture acquired RFCL for $22.18-27.73 mn  (100-125 crore). Now, reports put the current acquisition deal at $111 mn (500 crore).  This transaction thus marks the complete exit of ICICI Venture investment in RFCL. Around the same time, US-based Life Technologies decided to acquire certain assets of Gurgaon-based LabIndia, a long-time distributor of its products. The transaction is expected to allow the former to offer a more complete and complementary line of products directly to its customers. Mr Mark Smedley, head of Asia Pacific, Life Technologies, says,  “Our primary goal of acquiring LabIndia is to meet the increased demand from our customers, and better serve their needs. LabIndia has been a strong partner and a great steward of the Applied Biosystems brand for last 20 years, and can be credited for helping us build a thriving presence in India.” These two deals will see the increased presence of US-based companies — Life Technologies and Avantor — in the Indian biosupplier market. Given the increased government funding to research institutes and the growing biopharma industry, both the companies are expecting good opportunities for their growth. Further, these deals are customer-driven allowing companies to deal directly with them. The understanding of local needs will help in serving quality-specific products and further delivery on time. These two major deals it is expected will begin a trend of foreign companies acquiring well-established Indian biosupplier companies. Other Indian biosuppliers have positive sentiment about this development and think that this acquisition will bring about market consolidation. The Life Technologies-LabIndia deal creates a full-service business, allowing the former to provide its Applied Biosystems products directly to customers alongwith its Invitrogen portfolio, which includes GIBCO cell culture products, Lipofectamine transfection reagents, and a variety of benchtop instruments. Similarly, Avantor will use the RFCL network in India to push its products in the market, in exchange, RFCL can benefit from the global experience of Avantor, which can lead to great improvements in product offerings. Avantor will also expand its global presence in important geographies and end markets. With these two deals happening at a time when there is increased demand for quality research products, it is expected that in the long run, the ultimate beneficiaries will be the researchers in India. “The capabilities of US companies will receive major boost and definitely it is the best strategy on their part to enter Indian market by acquiring the established firms with good market presence.” — Mr Neeraj Gupta, MD, Imperial Life Sciences “This trend of consolidation will continue. Major MNCs will continue to look at Indian market. Everybody wants a piece of growing Indian market.” —Mr Rupinder Singh, MD, Biohouse Solutions “The two transactions have revalidated the potential of the bio lab supply sector. Post the Qualigen-Thermo Fisher deal, we have not seen large deals for a while now. I also hope that ‘revalidation’ and ‘re-evaluation’ of this sector encourages Indian entrepreneurs to grow more aggressively.” —Mr Arun Prakash, MD, Genetix Rahul Koul in New Delhi ]]> <![CDATA[Cipla at the forefront of HIV battle]]> https://biospectrumindia.com/news/95/1868/cipla-at-the-forefront-of-hiv-battle.html https://biospectrumindia.com/news/95/1868/cipla-at-the-forefront-of-hiv-battle.html Tue, 04 Jan 2011 19:18:00 +0530 Cipla has launched a first-of-its-kind ‘Mother-Baby Pack’, containing an entire range of anti-retroviral drugs to reduce the incidence of mother-to-child transmission of the disease A decade ago, when the accessibility of HIV/AIDS drugs in the under developed nations was low and the cost of treatment astronomically high, India’s leading generic pharmaceutical player, Cipla vouched to revolutionize treatments for HIV/AIDS by increasing affordability. They wanted to bring down the cost of treatment and make Anti Retroviral Drugs (ARVs) available at less than a ‘dollar-a-day.’ Soon, HIV/AIDS treatment became a reality with costs coming down from $12,000 to $300 per patient per year and the survival rates going up dramatically. In last 10 years, Cipla has remained focused towards this mission. “We were approached by UNICEF to produce this pack for PMTCT program. Cipla is proud to extend its world-class anti-retrovirals to the infected expectant mothers and the Mother-Baby Pack will increase adherence and play a pivotal role in the total prevention of mother-to-child transmission of HIV/AIDS” — Dr YK Hamied, chairman, Cipla In November 2010, the company went a step ahead in revolutionizing treatment for HIV/AIDS by developing a first-of-its-kind ‘Mother-Baby Pack’ to reduce the incidence of mother-to-child transmission of the disease. Developled in collaboration with UNICEF, this color-coded, take-home kit contains the entire range of ARVs and antibiotics required by an HIV-infected mother — starting from the 14th week of pregnancy until the sixth week after delivery. Developed in line with the latest World Health Organization (WHO) guidelines on Prevention of Mother-to-Child Transmission (PMTCT), the Mother-Baby Pack is adorned with simple graphics to help mothers identify the different sets of drugs each to be taken during pregnancy, labor and breastfeeding, covering the entire period when the transmission can occur. The pack also contains drugs for the newborn baby. Launched in Kenya, Cameroon, Zambia and Lesotho, the pack mainly addresses the logistical challenge of access to essential HIV drugs during the entire term of pregnancy and the susceptible period thereafter. High Risk of Transmission Everyday, over 1,000 infants contract HIV from their mothers at the time of birth, with the highest rate reported in sub-Saharan Africa. The risk of transmission from an infected mother to her infant ranges from about 15-45 percent, with 25-35 percent transmission occurring antenatally, 70-75 percent during labor, delivery and about 14 percent is attributable to breastfeeding. The intrapartum period is said to provide a crucial window of opportunity for prevention. Dr Duru Shah, chairman of Gynaecworld and Gynecworld Fertility Clinic, Mumbai and a Consultant to the Breach Candy Hospital, says, “In India, today, there are 40 percent chances of the disease transmission from the HIV infected mother to the child. Plus, there are maximum chances of the disease being transmitted to the child during delivery.” A Joint Technical Mission initiated by National AIDS Control Organization (NACO) in 2006, estimated that out of 27 million annual pregnancies in India, 189,000 occur in HIV positive pregnant women. In the absence of any intervention, an estimated cohort of 56,700 infected babies will be born annually. Doctors in India believe that the main issues are the lack of awareness about the risk of transmission to unborn infants, reluctance in going for HIV/AIDS tests at an early stage of pregnancy and accessibility to medicines especially to the far flung regions of India. Dr G Saple, HIV Consultant/ Surgeon at Mumbai’s Breach Candy Hospital, says, “The main problem is that mothers in India do not go for an HIV testing at early stages of pregnancy but at later stages when the child has already contracted the disease.” Another major issue is the lack of well-trained doctors in the field. Dr Janak Maniar, HIV Consultant at Jaslok Hospital, Mumbai, says, “The number of doctors looking at HIV/AIDS in India is even less than 100 today.” Benefits of the Pack Now, with the launch of the Mother-Baby Pack, an HIV positive mother-to-be even in the remotest corner of the least developed nations would have access to essential PMTCT (Preventing Mother to Child Transmission) drugs during her entire term of pregnancy, in the convenience of her own home. Launched in Kenya, Cameroon, Zambia and Lesotho, the pack mainly addresses the logistical challenge of access to essential HIV drugs during the entire term of pregnancy and the susceptible period thereafter On making another landmark contribution in the fight against HIV/AIDS, Dr YK Hamied, chairman, Cipla, says, “We were approached by UNICEF to produce this pack for the PMTCT program. Cipla is proud to extend its world-class antiretrovirals to the infected expectant mothers and the specially designed Mother-Baby Pack will increase adherence and play a pivotal role in the total prevention of mother-to-child transmission of HIV/AIDS.” The drugs for the Mother-Baby Pack are being manufactured and packaged in Cipla’s manufacturing units in Goa and Patalganga, Maharashtra which are approved by WHO-Geneva, US FDA, MHRA-UK and various other regulatory bodies. Commenting on the benefits of this pack, a reputed Obstetrician and Gynecologist from Mumbai, says, “HIV-infected mothers usually do not take the entire course of drugs due to many reasons. The benefit of this pack is that since it consists of drugs which covers the entire period right from a mother’s pregnancy to post delivery, it ensures that she takes the entire course of medicines. It is an easy-to-use package for mothers.” Doctors point out that this development would drastically help in reducing the number of child deaths due to AIDS. According to a report by UNAIDS, globally, in 2009, an estimated number of 370,000 children contracted AIDS during the perinatal and breastfeeding stage. The pack costs $70 and covers a period of 12 months. Dr YK Hamied further adds, “Cipla would make the Mother-Baby Pack available to various Ministries of Health in sub-Saharan Africa, various NGOs and donor agencies for their treatment programs.” Cipla’s AIDS mission In the past 10 years, Cipla along with a handful of other Indian generic players played a crucial role in reducing the incidence of HIV/AIDS in the country. Cipla’s contribution to PMTCT was towards the ‘Nevirapine donation program’ aimed at reducing the rate of mother-to-child transmission by 50 percent in the developing countries. Through this program, Cipla offered the anti-HIV drug ‘Nevimune’ free of cost to agencies or Ministry of Health that approached Cipla with its HIV/AIDS treatment programs. Pregnant women who were found to be HIV positive were given a single dose of Nevirapineat at the time of labor; their newborn babies also got a single dose of Nevirapine immediately after birth so as to prevent transmission of HIV from mother to child. In 2001, taking a significant step, Cipla’s innovative Fixed Dose Combination of the ‘triple cocktail drug’, Triomune, simplified treatment and fostered adherence. The company was also the first to prepare a child-friendly three-in-one paediatric formulation, Triomune Baby and Junior, for the young population infected with HIV/AIDS. Cipla thereafter initiated a patient education campaign ‘Living with Hope’ in 2004 and has been conducting several ongoing training programs and CMEs in India and internationally to cover various aspects of HIV/AIDS treatment including adult, paediatric, MTCT, PEP. Currently, the company has more than 45 ARV formulations in its portfolio and Cipla supplies these to over 120 countries including various Ministries of Health, Government of India and to several international AIDS agencies like UNICEF, MSF, SCMS/PEPFAR, Clinton Foundation, IDA, PAHO among others. Today, almost one out of three HIV-infected patients in the third world is on Cipla drugs as it continues to work towards its commitment that ‘none shall be denied.’ Nayantara Som in Mumbai ]]> <![CDATA[The Metahelix Way]]> https://biospectrumindia.com/news/95/1953/the-metahelix-way.html https://biospectrumindia.com/news/95/1953/the-metahelix-way.html Tue, 04 Jan 2011 19:15:00 +0530 When in mid-November the 8th BioSpectrum Awards Jury decided to give the Product of the Year Award to the cry1C bt gene developed by Metahelix Life Sciences, the industry was actually recognizing the tireless efforts of a band of scientists-turned-entrepreneurs. Ten years ago, they left their cushy jobs in top seed companies and decided to develop a truly Indian transgenic product to compete with the world’s best. For nearly a decade, helped by angel investors, the Metahelix team pursued their dream, despite many ups and downs, a complex and long winding regulatory path. BioSpectrum has been chronicling the remarkable strides made by Dr K K Narayanan and his team all these years. Even when I met him to profile the product in late November, Dr Narayanan was clear that Metahelix will take a cautious approach with the product and spend a few years to earn the Indian farmers’ goodwill and product endorsement. At the same time, Dr Narayanan was fully confident about the gene and was steadfast in his belief that the benefits of this efficient technology should reach farmers around the world. And he had confided that the only way that can happen will be with the support of strategic investors who have deep pockets. He was already preparing the ground for that. Two weeks later, it happened. The TATA group recognized the importance of Metahelix and has given the company the requisite backing and financial muscle by picking up a majority stake through Rallis India, the group’s agriculture arm. Metahelix has got an infusion of nearly $20 million when the angel investors exited through the Rallis arrangement. These funds will help Metahelix to prepare for the initial forays into the national market and take the right steps to seek regulatory approvals in the major cotton growing countries. The gene will be inserted in cotton hybrids initially and later into a variety of vegetable crops and cereals. More than that, the company can now count on the huge financial strengths of the TATA Group to fulfill its ambition to put an Indian gene in crops around the world. Biocon’s Pfizer deal and Metahelix-Rallis arrangement are giving way to a new business trend in the small but growing Indian biotech industry. Within a decade of the emergence of this industry, despite the small revenue size, the companies are able to think globally and clearly aim to put India-made products in global markets. Very few India-made products have succeeded in doing so on their own terms. The Metahelix way will have many more followers in the industry in the coming decade. You have all got used to the familiar pages of BioSpectrum for the last five years. Change is the only constant in all walks of life. BioSpectrum too has undergone some changes. The new look BioSpectrum you hold in your hands is the result of a year-long effort by the magazine’s design and editorial team, with inputs from external experts, to give it a contemporary look and feel. We have chosen a design that will straddle the multiple delivery formats of print, digital and online seamlessly, while preserving the essential character of the trusted biotech magazine. I hope you all enjoy the new design. Do let us know what you think of the change. Wish you all a very Happy and Happening New Year 2011. Narayanan Suresh Chief Editor sureshn@cybermedia.co.in ]]> <![CDATA[Global nanotech market to be worth $1.6 tn by 2013]]> https://biospectrumindia.com/news/95/1366/global-nanotech-market-to-be-worth-1-6-tn-by-2013.html https://biospectrumindia.com/news/95/1366/global-nanotech-market-to-be-worth-1-6-tn-by-2013.html Tue, 04 Jan 2011 19:12:00 +0530 The global nanotechnology industry is worth $300 billion and by 2013  the global market for nanotechnology-based manufacturing goods will be worth $1.6 trillion. It is estimated that in the next 30 the industry will be worth $35,000 billion. It is high time for India to venture into this booming sector. There is a need to integrate the excellence of industry, academia and research institutes, with the backing of government funding. Mr Ashok Kumar Manoli, principal secretary to government, Department of Information Technology, Biotechnology, and Science & Technology, Karnataka, said, “Nanotechnology is one of the most exciting areas of research. It is understood to be the third technological revolution in the world that will enable man to control matter at the atomic scale. Nanotechnology will revolutionize key areas like materials, information and communication technology, medicine, genetics, electronics, energy, environment, biotechnology and agriculture.” Mr Manoli was delivering the inaugural address, at the two-day Bangalore Nano December 8-9, 2010. “Karnataka is spearheading the nano-revolution in India, propped by its astounding success in the field of Information Technology and Biotechnology,” added Mr Manoli Addressing the plenary session on the topic, “Nanotechnology: A key tool in attaining developmental goals”, Dr W Selvamurthy, chief controller (R&D), Defence Research and Development Organization (DRDO), Government of India, said, “DRDO uses the possibilities of nanotechnology to strengthen Indian defence sector. DRDO has alloted about $45 million (`200 crore) for nanotech research. Twenty labs under the aegis of DRDO are focusing on nanotech research. In the health science area, researches are underway to use nanotechnology for online physiological monitoring, protection against biological and chemical warfare, and protection against nuclear radiation. Researches are also carried out for enhancing biomedical applications such as biosensing and targeted drug delivery. We are also coming up with a nano foundry that will function as an interface between DRDO and other government labs, industry and academic institutions.” During his plenary speech, Dr MK Bhan, secretary, Department of Biotechnology, Government of India, said, “Nanoscience and biotechnology can be used effectively to find innovative solution to the existing health-related issues prevailing in India. Whenever it comes to new technologies, India has been hesitant to venture into it at an early stage. The same hesitation prevails in nanotechnolgy as well. We need new technologies, as it will help us bring in product innovation. Nanotechnology can enhance the basic tools of proteomics and genomics. To gain prominence in nanotechnoloy market, India needs to create effective people across value chain. Lack of regulation and risk assessment could hamper the nanotech sector, so industry needs to understand and follow regulatory sciences at all stages of development.” ]]> <![CDATA[NSA submits GM crop safety report to government]]> https://biospectrumindia.com/news/95/3079/nsa-submits-gm-crop-safety-report-to-government.html https://biospectrumindia.com/news/95/3079/nsa-submits-gm-crop-safety-report-to-government.html Tue, 04 Jan 2011 19:09:00 +0530 Once again the hopes have been raised on the possible rethinking by the government on lifting the moratorium issued on Bt Brinjal since Feb 9, 2010. This is after the six National Science Academies (NSA) in India submitted the report titled “The Role of GM Crops” to the Union Minister of Environment and Forests (MoEF), Government of India. In order to have the opinion of the distinguished scientists and experts on the genetically modified crops, the MoEF had earlier asked the NSAs to examine all aspects of safety and utility of GM crops to Indian environment and agriculture. The Agricultural Group (AG) of the Association of Biotechnology Led Enterprises (ABLE) has also welcomed the report resubmitted by the six NSAs. The ABLE – AG added that this report is based on complete scientific assessment of the safety and utility of GM crops to Indian agriculture. Dr Shanthu Shantharam, executive director of ABLE-AG, said, “The contents of academies report were based on scientific facts and this latest report is in line with many other scientific reports and opinions published by other leading scientific establishments of the world. When scientific reasoning prevails, and when politics and ideology are kept out of science and technology issues, everyone wins.” Govt to monitor pharma takeovers Following recent takeovers of Indian pharmaceutical companies by multinational companies (MNCs), there seems to be a possibility in a rising number of similar takeovers. Considering the fact that these events could have a direct impact on the Indian healthcare scenario as well as on pricing and availability of medicines in India, the government has felt an immediate need for an appropriate assessment, in order to find out whether it will actually affect the patients in India. While revealing plans by the government in this regard, the Minister of State for Chemicals and Fertilizers, Mr Srikant Kumar Jena said, “The Department of Pharmaceuticals has requested the Department of Commerce to conduct a study on the recent takeovers of Indian companies by MNCs. Thereafter, the recommendation could be placed before the Economic Advisory Council to the Prime Minister and/or competent authority.” Pharma gets a funding boost The Science and Engineering Research Council (SERC) under the Department of Science and Technology (DST), Government of India, has emerged as a national model for a transparent and rigorous peer review mechanism. International science and technology cooperation for joint funding through bottom-up models is based on SERC peer view mechanism which demonstrates cultural similarities with many developed countries in Europe. SERC is planning to make efforts to come up with more product patents and leverage the Indian pharma industry to take newer molecules for clinical trial phases. The council also plans to study the diseases prevalent among the captive as well as in restricted geographical area of endangered animals and birds.  According to the Ministry of Science and Technology, under the SERC mechanism, a total of 530 new projects costing about $35.58 mn (160.3 crore) were sanctioned under broad areas of science and engineering in 2009-10. In addition, funds were sanctioned for about 1,250 ongoing projects. A total of 24 R&D projects including collaborative and loan projects have been initiated during the same year. The DST is also putting efforts to financially support industries as well as publicly funded institutions by providing projects for development of drugs for diseases pertinent to our country and certain lifestyle diseases like leprosy, malaria, tuberculosis, Japanese encephalitis, syphilis, leishmaniasis, filariasis, HIV/AIDS, tetanus, measles, drug resistant enteric Fever, hepatitis B, skin disorders such as leucoderma and psoriasis, gastrointestinal disorders such as diarrhoea and cholera besides infections leading to trypansomiasis and ascariasis. The Ministry of Science and Technology with a mandate to strengthen R&D in India during the 11th Five Year Plan period has embarked upon multi-pronged approach to further strengthen its service to the science and technology sector. ]]> <![CDATA[Sanofi, Oxford in JV for oncology research]]> https://biospectrumindia.com/news/95/1652/sanofi-oxford-in-jv-for-oncology-research.html https://biospectrumindia.com/news/95/1652/sanofi-oxford-in-jv-for-oncology-research.html Tue, 04 Jan 2011 19:06:00 +0530 France-based pharma company, Sanofi-aventis and Oxford University, UK, have entered into an agreement to conduct multi-phase oncology clinical and translational research with INDOX, India’s leading academic oncology network. Through this partnership, Sanofi-aventis will have access to the expertise and experience of India’s top oncologists and scientists to conduct clinical research to the highest internationally recognized ethical standards. “The collaboration between Sanofi-aventis, Oxford University and Indian Cancer Centers, foster a model for academic researchers and industry to work together for the benefit of patients. This relationship not only helps to train the next generation of cancer researchers in India, but also allows Sanofi-aventis to efficiently develop drugs in premier cancer centers in India, which also provide access to anti-cancer drugs to help patients fight cancer,” said Dr Debasish Roychowdhury, senior vice president & head (Oncology), Sanofi-aventis. Intestinal tissue transplantion, a reality For the first time, scientists have created functioning human intestinal tissue in the laboratory from pluripotent stem cells. Scientists from Cincinnati Children’s Hospital Medical Center in the US claim that their findings will open the door to unprecedented studies of human intestinal development, function and disease. According to the researchers, the process is also a significant step towards generating intestinal tissue for transplantation. “This is the first study to demonstrate that human pluripotent stem cells in a petri dish can be instructed to efficiently form human tissue with three-dimensional architecture and cellular composition remarkably similar to intestinal tissue,” said Dr James Wells, senior investigator of the study and a researcher at the division of Developmental Biology at Cincinnati Children’s Hospital. In the study, the research team led by Dr Wells used two types of pluripotent cells: human embryonic stem cells (hESCs) and induced pluripotent stem cells (iPSCs). iPSCs were generated by reprogramming biopsied human skin cells into pluripotent stem cells. Researchers used both iPSCs and human embryonic stem cells in this study so they could further test and compare the transformative capabilities of each. Flu infections may prevent asthma As per the findings of a new research on asthma, scientists at Children’s Hospital Boston (US), report that the influenza virus infection in young mice protected it from developing allergic asthma. The same protective effect was achieved by treating young mice with compound isolated from the bacterium Helicobacter pylori (H. pylori), a bacterium that colonizes the stomach and is best known for causing ulcers. The findings, published in the Journal of Clinical Investigation, provide a potential immunological mechanism in support of the “hygiene hypothesis,” an idea that attributes the increasing rate of asthma and allergies to the successful reduction of childhood infections with vaccines and antibiotics. This is supported by epidemiological studies associating certain childhood infections, such as respiratory viral infections or gastrointestinal infection with H. pylori, with a lower risk of developing asthma. In mice, influenza A infection helped it by expanding an immature cell type in the lung known as natural killer T (NKT) cells, part of the innate immune system. The same beneficial NKT cells in the lung could be expanded by several NKT-stimulating molecules known as glycolipids, including one isolated from H. pylori. The latest study reports on this new subset of inhibitory NKT cells that seem to prevent allergic reactions in the airways, if stimulated at the right time by the right infectious agents or the right glycolipid. ]]> <![CDATA[Northeast India poised to be major pharma hub]]> https://biospectrumindia.com/news/95/7006/northeast-india-poised-to-be-major-pharma-hub.html https://biospectrumindia.com/news/95/7006/northeast-india-poised-to-be-major-pharma-hub.html Tue, 04 Jan 2011 19:00:00 +0530 Indian pharma companies are investing considerably in the northeast region owing to the tax benefits offered under NEIIPP 2007 A good many pharma companies are moving toward the northeast because of the multitudes of tax benefits being offered by the state under ‘North East Industrial and Investment Promotion Policy (NEIIPP), 2007. The benefits include excise duty exemption on finished products, income tax exemption and capital investment subsidy on investment in plant and machinery, among others. Consequently, many pharma  companies are shifting their manufacturing units from Baddi, Himachal Pradesh to Sikkim. Sikkim, a tiny hill state in the Eastern Himalayas with a geographical area of 7096. sq. kms and bestowed with abundant natural resources, is now home to as many as 14 major pharma companies. These include units by Cipla, Sun Pharma, Zydus Cadila, Alembic, IPCA, Alkem Lab, Intas Pharma, Torrent Pharmaceuticals and Unichem. Some of these companies have invested over $400 mn (2000 crore) in the last three years. Under the NEIIPP announced by Department of Industrial Policy and Promotion (Ministry of Commerce and  Industry, Government of India), all new units and existing ones going for expansion in the northeast region get a full exemption from income tax and excise duty, apart from a 30 percent subsidy on investment in plant and machinery, together with interest subsidy of 3 percent on capital loan and a reimbursement of 100 percent insurance premium. The northeastern region of India comprises the states of Arunachal Pradesh, Assam, Meghalaya, Manipur, Tripura, Mizoram, Sikkim and Nagaland. All the eight states have high biodiversity and have been a priority for leading conservation agencies of the world. The region has been identified by the Indian Council of Agricultural Research (ICAR) as a center for rice germplasm. The National Bureau of Plant Genetic Resources (NBPGR), India, has highlighted the region as being rich in wild relatives of crop plants. The northeast is also rich in medicinal plants and many other rare and endangered taxa. Northeast also opens up the possibility of setting up research and development centers to work on herbal medicines. To support R&D in pharma, biotech and allied activities in the region, the Department of Biotechnology (Ministry of Science & Technology) has came up with initiatives with education, bioinformatics and infrastructure projects. The DBT has earmarked 10 percent of its total budget amounting to about $20 mn (100 crore) on these projects. Biodiversity documentation is significant for NER About 51 forest types are found in the region broadly classified into six major forest types viz., tropical moist deciduous forests, tropical semi evergreen forests, tropical wet evergreen forests, subtropical forests, temperate forests and alpine forests Out of the nine important vegetation types of India, six are found in the North Eastern region. These forests harbor 80,000 out of 15,000 species of flowering plants. These include:  40 out of 54 species of gymnosperms 500 out of 1012 species of Pteridophytes 825 out of 1145 species of orchids 80 out of 90 species of rhododendrons 60 out of 110 species of bamboo 25 out of 56 species of canes   In terms of floral species richness, the highest diversity is reported from the states of Arunachal Pradesh and Sikkim amongst the northeaster states. These species belong to about 200 plant families out of 315 recorded from North East India. Some of the families such as Nepanthaceae, Illiciaceae and Clethraceae are unique in the world. These families are reported from the South East Asian countries and are represented by a limited number of species like Clethra sp. and Nepenthus khasiana in North East India (A. R. K. Sastry pers comm.). According to the Indian Red data book published by the Botanical Survey of India, 10 percent of the total flowering plants in the country are endangered. Of the 1500 endangered floral species, 800 are reported from North East India. High biological diversity is often related to the forest cover of a region. Most of the North Eastern states have more than 60 percent of their geographical area under forest cover, a minimum suggested coverage for the hill states in the country. The fauna diversity is relatively better documented than its floral counterparts for the North Eastern region. However the discovery of newer species like the Tawang Macaque (Macaca sp) and range extensions of the Chinese goral (Nemorhaedatus caudatus) and leaf deer (Mentiacus putaoensis) highlights the dire need for more extensive research and systematic documentation of biodiversity of the North East. Source: National Biodiversity Strategy and Action Plan Report (2003) DBT support programs Infrastructure A biotechnology incubator for entrepreneurship development in Assam Established regional research center of IBSD in Sikkim State Women’s biotechnology park Bioresources Centre at NEHU, Shillong Modern infectious disease detection laboratory/infrastructure in 11 Medical Schools A rural bio-resource complex targeting 1500 households from 15 villages spread over 5 clusters  Establishment of biotech hubs and state nodal centers Bio-informatics Establishment of North Eastern Bioinformatics Network (NEBINet) On-line information access facility for Schools Creation of e-Journal Access Facility NER-DeLCON- E-Journals access to NER instituions Education Promote star colleges of (North East Region) NER in life sciences education and training Programme support in the areas of biotechnology to Indian Institute of Technology (IIT), Guwahati Programme support to clinical research network in NER Network programme on developing drugs from medicinal plants of NER Network on management of classical swine fever in piggeries in NER Launching of special fellowship/associateship DNA Clubs (DBT’s Natural Resources Awareness Clubs) for NER Exclusive biotechnology overseas associateship for NER scientists Establishment of North Eastern Bioinformatics Network (NEBINet) On-line information access facility for Schools Creation of e-Journal Access Facility NER-DeLCON- E-Journals access to NER instituions Narayan Kulkarni in Bangalore ]]> <![CDATA["We're setting up a base in the US"]]> https://biospectrumindia.com/news/95/1418/were-setting-up-a-base-in-the-us.html https://biospectrumindia.com/news/95/1418/were-setting-up-a-base-in-the-us.html Tue, 04 Jan 2011 18:53:00 +0530 Dr Vishal Warke, director (R&D), HiMedia Laboratories, Mumbai HiMedia Laboratories, a leading manufacturer of products for microbiology, parasitology, immunology, serology and virology is counted amongst the world’s few companies possessing high-technology know-how for manufacturing microbiological culture media. HiMedia has over 3,000 microbiology products. Its products are available and used in almost all parts of the world, and compete with other products of international repute. In an exclusive with BioSpectrum, Dr Vishal Warke, director (R&D), HiMedia Laboratories, throws light on the activities of the company and its achievements in the past two years, which include proactively combating the H1N1 menace in the country. Excerpts from the interview. Q What are the advantages of the Swine Flu Transport kits introduced by HiMedia? The Swine Flu Transport kit was introduced prior to the H1N1 epidemic attack in India. We started our work when swine flu surfaced in Mexico; and also, around that time there were some ongoing investigation at the National Institute of Virology (NIV), Pune. We were also alerted by marketing team about the flu. Realizing the need, we became proactive in producing these kits. This is a unique kit, sold at one-tenth the cost of other swine flu kits available in the market. This transport kit uses a unique swab (known as flocculated swab) wherein, just by placing it in the nasal cavity, it draws in a lot of viral particles. The nature of this kit is such that the entire material can be preserved in the swab, and held in place. The medium consists of certain components so that the virus remains in the swab for a good period of time, without it being killed. Q How much investment was made for developing the swine flu kits and how was it marketed? Swine flu kits were produced in millions, and were supplied to all cities in India. The only concern for us was, scalability. We faced a situation where all our distributors and clients (mainly hospitals) loaded us with huge orders; but we could supply these swabs only in parts. We increased our investment on the production of these kits. Our infrastructure in Nashik (Maharashtra) was already in place, and so were our clean rooms. We acquired six new biosafety level type 2 cabinets, and bought in filtration equipments and accordingly, we mobilized manpower. We procured 15 ml tubes from all parts of the world. During the epidemic, around 99 percent of the swabs used in the country were manufactured by HiMedia. The demand for the viral transport media and swabs was very high at that time; and we could have increased the price and gained benefits out of it, but we chose not to. While other companies sold their swabs at an exorbitant rate, the price of our swabs were kept around $1.11 (`50). It was a national emergency; and supplying excellent quality, affordable, viral transport kits, was our contribution to the cause. Q Apart from swine flu kits, what are the other milestones of HiMedia in the past two years ? HiMedia is a group of companies, and Warkem Biotech is our sister company. We produce HiVeg Peptones (Hydrolysates prepared from non-animal sources, such as wheat, corn and soy) that are manufactured by Warkem Biotech. The manufacturing plant has been scaled up; and will cater to the global needs, particularly with the increasing demand for non-animal protein hydrolysates - given the risk of Mad Cow Disease - from animal-origin material. This apart, we have been supplying different kinds of kits on a regular basis. We have launched comprehensive and easy-to-perform kits for soil and water analysis, for farmers and agriculturists. We have also launched kits for milk adulteration testing, and detection of arsenic in water. Another kit that we have launched is to detect mastitis in cows (in collaboration with Shree Chitra Tirunal Institute, Kerala). We also have cost-effective kits for detection of sickle cell anemia (screening as well as confirmation). The National Biodiversity Screening Program was introduced two years ago, by the Department of Biotechnology (DBT), to screen the rich and diverse flora and fauna in India. This program is being conducted by the DBT along with 13 key institutions in India. HiMedia is a partner in supplying culture media, to isolate and then to maintain, the microbes. We have also entered stem cell and primary cell market. We have already made these cells and media available to our scientists at an affordable cost. The key bottleneck in the market, is the price. We will soon scale up production for stem cells, primary cells and their media; and hope to reduce the prices significantly. Presently, we are importing them; although we are also setting up systems to separate them in India. By 2011, we hope to manufacture and make these available in India. Q Within your portfolio offerings, which were the revenue churning segments for HiMedia in the past two years? Culture media is the basis of our business; and brings in the maximum revenue. We also get a sizable chunk of revenue from exports, as about 50 percent of HiMedia’s production today is exported. We cater to 125 countries; and our vision was to produce media in India and sell them abroad to compete with the best brands in the world. Because, the Indian market, in terms of microbiology and media, is witnessing a saturation point; many people are moving away from media, towards automated systems that are also on our priority list. On the global front, we have partnered with US-based VWR, and are making inroads into the US market. We have offices in the US, Russia, CIS and Brazil, where we have a strong presence and are growing rapidly. The US is the largest market for us. Due to the economic recession, most companies overseas are looking at cutting down costs, and therefore, want good quality media, at affordable prices; and that is where HiMedia fits the bill. In cell culture, we have advanced in a big way into serum-free and animal-free media. HiMedia has given out serum-free media samples; and have received very encouraging feedback. Moreover, we are also looking at expanding our chemical and fine chemical supplies segment, since we realized that many reputed players in the fine chemicals and reagent market, are actually sourcing chemicals from India; and reselling them to India, after relabeling in their respective countries. We have set up a world class chemical testing and validation laboratory with this objective. Q Is HiMedia looking at any strategic alliance, partnership or acquisition in near future? Nothing on the cards as yet. Many companies were interested in acquiring HiMedia and we have received attractive offers. But, we are scientists first, and businessmen later, so we declined the offer. We have people who want to partner with us for the chemical division; and talks are in progress on that front. We are open to making acquisitions, particularly for ready prepared media which has a demand in North America and Europe. So, we are looking at setting up a base in the US, where we can ship our powdered media to be re-hydrated there. Q What are the strategies for the company in the coming years? We are focusing on biopharma and vaccine industry. They are using our hydrolysates and media. We are focused on providing a complete solution to them, instead of simply supplying products. We essentially have products in microbiology, cell culture, molecular biology and plant tissue culture. We are also planning to develop certain products for fertility clinics; although that is still in the ideation phase. Additionally, we have expanded our ready prepared or pre-poured microbiology media plates facility, to produce 50,000 plates per day. With this, we hope to cater to the burgeoning Indian pharmaceutical market, as well as exporting them to nearby countries. In the cell culture space, we are looking at introducing induced pluripotent stem cells (iPS) because ,this is the future; and these are currently exorbitantly priced, and difficult to procure in India. Q Will there be any change in the business model? We are not looking at any change in our business model, as that has served us well over the years. We are not in a hurry to grow big overnight, and have a conservative approach, and managed to keep a healthy and steady growth rate over the last decade. Our finances are well-managed, and further funding is not a problem as financial firms are willing to give us funds. However, at this point, we are not looking at any additional funding, either through equity funding or IPO. Technologically, we have our identity, and we would like to preserve that, and hold on to our conservative approach. Nayantara Som in Mumbai ]]> <![CDATA["Biosimilars boosts the growth of pharma industry"]]> https://biospectrumindia.com/news/95/1728/biosimilars-boosts-the-growth-of-pharma-industry.html https://biospectrumindia.com/news/95/1728/biosimilars-boosts-the-growth-of-pharma-industry.html Tue, 04 Jan 2011 18:19:00 +0530 Mr Satish Reddy, managing director & COO, Dr Reddy’s Laboratories, India Dr Reddy’s Laboratories, Hyderabad (India) touched revenues of $1.56 billion in 2009; and set a target of $3 billion by 2013. Ever since the target was set, the company has been engaged in executing strategies, making alliances with global giants like GSK, launching new products in the market, and reaching out to the set market. Revealing the growing potential, the company has recently launched zafirlukast tablets, a bioequivalent generic version of accolate, in the US market; and has also bought GSK’s oral penicillin manufacturing facility in Tennessee, US. All the activities are being streamlined to touch the set revenue scale; and to emerge among the top five companies in US. In an interview with BioSpectrum, Mr Satish Reddy, managing director & COO, Dr Reddy’s Laboratories, during his visit to Singapore, shares his plans and thoughts about the industry and changes required to excel. Q What are your strategies to double your revenue by 2013? Mr Reddy: In 2009, we touched revenues of $1.56 billion, and the next goal ahead of us is to reach to the $3 billion mark, by FY13. While we aim to double our revenue targets in the next three years; there are factors that would accelerate this growth. On one side, we have the US market that has an immense potential in the year to come. For instance, in the next three years, many products would go off-patent, and this opens up opportunities to develop the generic equivalent. Secondly, we have shifted our focus more towards emerging markets that have untapped potential, as compared to the developed markets. In market capitalization, we have already created our presence in India, Russia and Venezuela. In the next couple of years, the focus would continue on India and Russia, since there are expectations of double-digit growth; and we are growing fast in these regions. Thirdly, we will continue to launch new range of products in the market, to reach out to a broad group of buyers. We are focusing on complex manufacturing products; and there are already some products in the pipeline. In the years to come, these complex products are sure to create a big market share in the industry. In 2011, we will launch 15 new products in US; 50 in India; and seven or eight in Russia. Q Could you tell us about your approach to biosimilars? Do you consider it a key profit accelerator? Mr Reddy: Biosimilars is a promising area, and is sure to yield success for the industry. We have many initiatives in this regard; and have several biosimilars in the market. Biosimilars hold significant importance for Dr Reddy’s achievement plans. We have already launched Grafeel (biosimilar filgrastim) and Reditux (biosimilar rituximab) in India; and the value that we create out of biosimilars is very significant. The third biosimilar product that we have launched, Cresp is the first generic darbepoetin alfa drug in the world, for treatment of anemia due to chronic kidney diseases. We are the world’s first biosimilar manufacturer of these products. This gives us an edge in the industry; and the capacity to build on it, introducing more products in targeted countries. Some of our products will be launched in the US as well. Q After your GSK collaboration, what are your new milestones? Mr Reddy: Post our relationship with GSK, we have a presence in almost 40 different countries in Africa, the Middle East, Asia Pacific and Latin America. We decided to get close to different markets; and there are many countries where we need to make a presence. With GSK’s strategy to reach the emerging market, we are demonstrating things that we are good at, like manufacturing; and GSK has a strong sales and marketing presence. Therefore, it is a good combination and a revenue-sharing relationship. Q What are your strategies for strengthening the manufacturing base across the globe? Does a local manufacturing unit help in acquiring a particular market? Mr Reddy: Over the last few years, we have been setting up manufacturing plants, and are interested in Special Economic Zones. Our manufacturing units are based mostly in India. We have similar bases in Mexico and UK as well; and are planning to set up one in Russia, in the future. I don’t believe that having a manufacturing base in a foreign land always helps in making customized products. For instance, the Russian market is based on 75 percent exports; and the local production is very less, hence, it does not make a business sense to set up manufacturing units in our target zones. Q Could you share some of the latest changes that Dr Reddy’s has implemented in its R&D model? Mr Reddy: For the drug discovery process, we had two outfits. One is done through a 100 percent subsidiary, as we have collaborative programs through innovative councils; and second, is our own discovery programs. Now, drug discovery is part of our business; and we have restructured our R&D department. We have combined the drug discovery unit with the business model that will help in creating revenues from innovations. We are also taking steps toward differentiated formulations and new drug delivery techniques. Q How do you see India positioned in the game of drug discovery? Will India be a top destination for new drugs? Mr Reddy: Drug discovery is a long term game. The stretch between discoveries and manufacturing takes a long time; and if one fails at a later stage, it can suspend the whole process. It is a long frustrating game, and unless one reaches the final stage of approval, there is no value chain. Though it is a long process with high involvement of risk and cost, the rewards are also very high. India is a young destination for drug discovery. Biotechnology developments in India have been taking place for the last 15 years; whereas in the US, for about 100 years. However, soon India will also develop products of its own. Pharmaceutical companies in the US have sufficient investment and funding opportunities; whereas India, unfortunately, has limited funding options. Amrita Tejasvi in Singapore ]]> <![CDATA[Indian biosimilars market set to clock $2 bn by 2015]]> https://biospectrumindia.com/news/95/1698/indian-biosimilars-market-set-to-clock-2-bn-by-2015.html https://biospectrumindia.com/news/95/1698/indian-biosimilars-market-set-to-clock-2-bn-by-2015.html Tue, 04 Jan 2011 18:16:00 +0530 Robust economic growth figures and increasing income levels may soon elevate India's position in the global biosimilars market amongst the emerging economies by 2015. Commenting on the biosimilars market growth, Mr Hareesh Parandhaman, head of business development - Biotechnology, Lupin Pharmaceuticals, said, â€œIndian biosimilars market is set to grow at 20 percent by 2015 at par with the global growth rate. The global market for biosimilars is worth $120 billion and emerging markets contribute 18 percent of it. Indian biosimilars market is estimated to register $2 billion by 2015.â€? It is noteworthy that the Indian pharmaceutical exports have been consistently growing. So far, the market share of India in biosimilars space has been negligible, opines the industry experts at the CPhI India Conference Series 2010 held in Mumbai. The US and EU will undoubtedly be the high growth markets for India. Sales of biologics in the US were $50 billion while sales in the EU were $26.1 billion in 2009. Also, in the coming years, oncology, rheumatoid arthritis (RA) and diabetes will prove to be lucrative therapeutic segments for Indian biosimilar players, with the rise of these diseases, globally. For oncology, growth will be in areas such as colon and breast cancer in the light of the increasing rise of prescriptions in the US. â€œIndia is the diabetes capital of the world followed by China. In the coming years, diabetes will not be an option but a pre-requisite if Indian players need to succeed in the market,â€? said Mr Parandhaman. Hence, as far as partnerships are concerned, Indian biosimilar players should choose partners who have a strong presence in either one or all of these therapeutic areas. Throwing light on some of the challenges, Mr KV Subramaniam, president and CEO, Reliance Life Sciences, said, â€œOne of the main reasons why the biosimilars market is growing slowly is because of the issues related to affordability. Another reason is the high costs of investments required in clinical research and development. Investments for setting up an infrastructure is also huge.â€? Experts unanimously observed that soon after the establishment of the US pathway for biosimilars (somewhere between 2013 and 2015), Indian players can see huge business in the space. Some of the Indian biosimilars players in India include, Biocon, Dr Reddy's Labs, Intas Biopharmaceuticals, Reliance Life Sciences, Lupin Pharma, Cipla and Wockhardt. Another lucrative arena for biotech players is the biobetters space. Biosimilar is a drug which is almost similar to its innovator product; a biobetter, on the other hand, is a drug which is the same class as that of the originator biopharmaceutical drug but has superior characteristics and advantages over its innovator. Despite the intensive clinical trials required for these class of drugs, experts equate biobetters with low risk, primarily because of improved safety and efficacy. Its therapeutic and commercial success has already been demonstrated in its innovator product, reducing chances of failure. Mr Morgan Morris, director of Cell Culture and Product Management at Millipore, said, â€œIf companies are looking at biobetters as a good source of investment then they ought to see that they have a right team in place, a full regulatory approval and timeline for development should be short.â€? He also added that if biobetter was just another way of getting around the intellectual property (IP), then the strategy would not be sustainable for long.â€? Medical equipment market to register $2 bn by 2015 India Semiconductor Association (ISA), the apex trade body representing the Indian semiconductor and electronics industry, has released a sector report on the opportunities in the Indian medical electronics field. The report was released by Dr Devi Prasad Shetty, chairman and managing director, Narayana Hrudayalaya; Dr Bobby Mitra, chairman of ISA; Ms Poornima Shenoy president of ISA; and Mr Vivek Sharma convener of the ISA Medical Electronics Segment were also present. According to the report, medical electronics market is valued at $853 mn and the Indian healthcare market is valued at $66.46 bn. The growth of Indian medical electronics market is driven by key factors such as: changing demographics and age profile that is prone to spend more on healthcare; rise of lifestyle diseases and the need for their diagnosis; the need to fill the gap in healthcare infrastructure through public-private partnership; growth in medical tourism to address international needs; entry of corporate into the healthcare arena; and increase in healthcare spend due to increase in health insurance. Usage of semiconductors is critical from power supply to display in medical equipment. This includes medical imaging, patient monitoring systems, digital hearing aids and infusion pumps, to name a few. Medical equipment market is estimated to grow at a CAGR of 17 percent in the next five years to register $2.07 bn. The domestic market for medical equipment currently stands at $820 mn. Annually, medical equipments worth $520 mn is manufactured in India, out of which equipments worth $75 mn are exported. The growth of medical equipment market is directly proportionate to growth of healthcare delivery which stood at $45.36 bn in 2009. Siemens, Wipro GE and Philips are the leaders in the space with 18 percent, 17 percent and 10 percent market share respectively; however, 45 percent of the market is addressed by smaller, niche domestic players. The role of a semiconductor components becomes more critical as the medical equipment devices move towards portable and smaller medical devices. Drug discovery market to touch $2.24 bn by 2016 With growing reliance on Indian pharma and biotech companies for drug discovery, the future drug discovery market in India is expected to grow strongly. According to a report by Research and Markets, the drug discovery market in India was $650 mn in 2009, representing a compound annual growth rate (CAGR) of 60 percent from 2004; and the market is expected to reach $2.24 bn by 2016. The major factors driving this growth include: huge cost advantages for the Western pharma companies of up to 60-70 percent, favorable local regulatory conditions to promote drug discovery, improved intellectual property (IP) protection after the introduction of the Trade-Related Aspects of Intellectual Property Rights (TRIPS), skilled workforce and Western-equivalent research infrastructure. Government support in India for the development of the drug discovery and development market has been largely focused on the purchasing power parity (PPP) model. Unlike China, the government in India has encouraged private entrepreneurship by helping the private biotech and pharma companies in their projects through collaborative research, loans or grant-in-aid. The Department of Science and Technology, India leads the government initiatives for encouraging R&D in the country, which has largely benefited the healthcare and pharmaceutical industry. The conceptualization, implementation and monitoring of the majority of the government initiatives has been handled by the Council of Scientific & Industrial Research (CSIR), India. The Department established several bodies like the Drug Development Promotion Board and the Technology Development Board, in order to provide funding for research projects across different sectors. These bodies have entered into collaborations with a number of drug discovery and development projects with Indian pharmaceutical companies. The agencies are also collaborating with various national level research institutes and universities across the country. Global healthcare spending to cross $71trillion by 2020 Spending on healthcare among the Organization for Economic Co-operation and Development (OECD) countries and Brazil, Russia, India and China (BRIC) nations will grow by 51 percent between 2010 and 2020; amounting to a cumulative total of more than $71 trillion, according to estimates from PriceWaterHouseCooper’s (PwC) Health Research Institute. Health spending in these areas is said to be rising faster than gross domestic product (GDP), magnifying gaps in budget deficits and spurring governments, to look to the private sector for ways to get a better value for taxpayers’ money. One trend that is emerging globally is the use of public-private partnerships (PPPs) to finance and manage health infrastructure and delivery, and, according to PwC, growth in this area could create a multi-trillion global market opportunity for private companies and investors, implement a more efficient use of taxpayer dollars, and offer better quality health systems. In a new report titled, Build and Beyond: The revolution of healthcare PPPs, PwC says that public health authorities around the world are increasingly contracting with private entities to manage healthcare services for defined populations or markets. These PPPs, which have largely been used for infrastructure finance, are evolving as way to slow the rising cost of healthcare and address larger problems in the health system. PPPs enable public health authorities to maintain oversight of standards while injecting private sector efficiency, fiscal discipline, new innovation and investment in efficiencies, driven by incentives to generate long-term cost savings and improve the quality of public health, according to PwC. PwC, which is said to have worked on over 100 health PPPs in 15 countries, sees the market growing substantially over the next five years, and says that the model has proven to save healthcare costs. For example, partnerships like Spain’s Alzira project, which includes hospital and primary care services, have saved government 25 percent of the cost of providing care, according to project partners interviewed for the PwC report. Already, competition for private capital has prompted governments in Europe, Asia, Africa and South East Asia, to establish PPP agencies that are charged with developing PPP policy recommendations, streamlining procurement and contracting for services. Key Highlights: ● By 2020, spending on health infrastructure among the OECD countries and BRIC nations will increase to $397 billion annually, up from $263 billion today. However, the larger market for health PPPs will be in non-infrastructure spending, estimated to be more than $7.5 trillion annually, up from $5 trillion in 2010. ● Between 2010 and 2020, the OECD and BRIC nations will spend cumulatively $3.6 trillion on health infrastructure and $68.1 trillion on non-infrastructure health spending. ● Health spending in the US accounts for approximately half of all health spending among OECD nations, but the biggest growth will be outside of the US. According to PwC projections, the countries that are expected to have the highest health spending growth between 2010 and 2020 are China, where health spending is expected to increase by 166 percent, and India, which will see a 140 percent increase. ● Among OECD countries, health spending as a percent of GDP will increase to 14.4 percent by 2020, up from 9.9 percent in 2010. Among BRIC nations, health spending as a percent of GDP is expected to increase to 6.2 percent in 2020, up from 5.4 percent in 2010 as their economies grow and they build out their health systems. In actual spending, this amounts to a 117 percent increase in spending over the decade, with China leading the way in spending increases. ]]> <![CDATA[The Year of Consolidation & Collaboration]]> https://biospectrumindia.com/news/95/6672/the-year-of-consolidation-collaboration.html https://biospectrumindia.com/news/95/6672/the-year-of-consolidation-collaboration.html Tue, 04 Jan 2011 18:00:00 +0530 The year 2011, is slated to be a year of consolidation and collaboration for the biotech industry. Mergers and acquisitions, strategic alliances and partnerships would be a continuing trend in 2011. Most of them will be inbound and like 2010, we will see valuations of domestic companies reach sky rocketing heights. However, we will witness more strategic alliances between MNCs and domestic firms more on the lines of the Pfizer-Biocon deal ($350 million, with $200 million upfront payment). Industry experts also predict that domestic companies will now turn to investing in novel molecules rather than plain low cost generics and follow on biologics. Keeping their focus intact, Indian biotechs are foreseeing the underlying opportunities and are optimistic about their growth in 2011. Besides expanding their employee base, companies are looking forward to significant investments in terms of R&D and on the commercial front. Further, companies in the services sector look to strengthen their existing capabilities and work on new business models that are rapidly emerging in the contract research industry. The dawn of the New Year is also expected to see the launch of newer vaccines and biopharma products. Making vaccines affordable and within the reach of poor and needy seems to be on the priority list of the vaccine companies. While, Public Private partnerships are burgeoning in the agri biotech sector, the companies in this space are betting big on genetically-modified crops and improving hybrid varieties of different crops. Although the moratorium on Bt brinjal continues, these companies are hopeful that the government will review the situation in the New Year. They are also optimistic that Bt brinjal will soon win the confidence of farmers and consumers alike and will set the ball rolling for other food crops, such as the Bt rice and Bt maize and Bt tomato. In 2011, one can expect domestic companies to come up with indigenous Bt genes. Bangalore-based Metahelix Life Sciences is one of the forerunners, with its cry1c gene receiving approval from GEAC for its use in two Bt cotton hybrids, MH5125 Bt and MH5174 Bt. India could also see the launch of Bt rice in the coming year, with DuPont receiving GEAC approval for field trials of its Bt rice. Tata Chemicals' subsidiary, Rallis India acquiring majority stake of 53.5 percent in Metahelix for over $20 million (99.5 crore) is seen as another important event in this sector. There is no holding back for Bioindustrial companies too. While keeping their focus on developing new products, these companies are also majorly looking at exports. Diagnostic companies will look to leverage the breadth of their portfolios to bring quality in vitro diagnostics into the market. Industry associations like the CII, ABLE, FICCI and ASSOCHAM are also looking forward to further catalyze the growth of biotech industry by bringing together different stakeholders for deliberation. Even the Government of India is keen on supporting R&D activities for developing novel molecules. In this regard it is planning to set up a new venture fund to promote drug discovery in India, with a start up capital of close to $45 million (200 crore). This could bolster drug discovery activities which till date, has been reeling under paucity of funds and capital. Further, the Department of Biotechnology (DBT), has been spending around $300 million-a-year (1,300 crore) to support research, development and innovation. India plans to spend over $150 mn (700 crore) in the next two years to boost production at biopharmaceutical firms, even as the local industry gears up for a global boom. The government will focus on developing infrastructure in the sector that makes drugs using biotechnology on increased demand for funding. DBT for the year 2010-11, had allocated an amount of about $260 mn (1,200 crore) as plan expenditure and $5 mn (22 crore as non-plan expenditure. Experts across all segments unanimously agree that the regulatory environment in India, come 2011, would become all the more stringent and well-defined. This would be applicable in avenues like biosimilars, stem cell therapies, clinical trials and pharmaceuticals. This will be a big boost for India because in the past, global heads of many MNCs were hesitant to invest in the country due to lack of a well defined regulatory structure. Clearly, experts are optimistic that it will be the pharma, biopharmaceutical and bioservices sectors, which will be the primary driving forces for industry growth. Companies are fully aware of the roadblocks that have been hindering the progress of the sectors so far, and are confident about consolidating their positions. Hence, 2011 will truly be a year of consolidation and collaboration! In the ensuing pages, BioSpectrum brings you some interesting insights from the industry observers and leaders for the year 2011.Biosimilars to drive growth More and more biosimilars would be launched in India, thereby strengthening the country's position in the global market. The regulatory environment in India would get progressively stringent on quality of biosimilars. Indian regulators can also be expected to subject imported biosimilars to the same level of scrutiny and approval as with biosimilars developed and manufactured in India. 2011 can witness more partnerships between Indian biotech and pharma companies. There would be more stem cell therapies and tissue engineered products in the Indian market. Regulations for stem cell therapies would get better defined. India would begin to make a mark in developing novel biotherapeutics as well. Company Outlook: Reliance Life Sciences (RLS) would continue to focus on developing and bringing in a range of biosimilars, including several monoclonal antibodies, to the Indian market as well as take them to other semi-regulated markets. RLS would be progressing its pipeline of specialty pharma products in oncology, steroids, hormones and peptides range. We are also looking to commercialize stem cell therapies and tissue engineered products in India. - Mr KV Subramaniam, president, Reliance Life Sciences Understand the trend or 'perish' India will gradually move towards an integrated and robust healthcare financing system, ushering in the dawn of a new paradigm, provided doctors should no longer remain the sole decision-makers for the drugs they prescribe to the patients and the way they treat the common diseases. Healthcare providers and medical insurance companies will start playing a key role in these areas by providing to the doctors well thought out treatment and prescription guidelines. For a significant proportion of the products that the pharmaceutical companies will sell, tough price negotiation is inevitable. Health Technology Assessment (HTA) or 'outcome-based pricing' model will play an important role in pricing healthcare products. A shift from just 'brand marketing' to marketing of a bundle of value-added comprehensive disease management processes along with the brand, will gradually be the order of the day. Over the counter medicines, especially originated from natural products for common and less serious illness, will curve out a larger share as appropriate regulations are put in place.Regulatory environment within the pharmaceutical industry will be much more stringent. Contrary to the expectations of many, valuation of the domestic pharmaceutical companies will continue to remain high, which, however, will not pose any serious impediment to the consolidation process in the industry. With these emerging trends, required wherewithal in the ball game of the Indian pharmaceutical industry will be quite different. In the evolving scenario, it may not be easy for the domestic players to adapt to all these changes fast and compete with the global players on equal footing. Companies which are already global players in their own rights, would be able to understand the nuances and implement them better in the new paradigm. These players, I reckon, would offer a tough competition to the global players, especially, in their own turf. However, for the smaller local players, the new environment could prove to be quite challenging, which in turn, could further accelerate the consolidation process in the Indian pharmaceutical industry. Thus, the 'writing on the wall' appears to be - â€œunderstand the trend and start preparing from now on or 'perish'.â€? - Mr Tapan Ray, director general, Organisation of Pharmaceutical Producers of India (OPPI)Reverse innovation to take center stage Biotech Industry will witness more strategic alliances in terms of CMOs and CROs. Reverse innovation will be setting in with more focus on vaccines, mAbs, and biopharmaceuticals. If government takes initiatives with more incentives and tax holidays backed by proper infrastructure, more overseas biotech companies will set up their facilities for manufacturing in India. Company Outlook: Serum Institute of India will launch some new affordable quality vaccines and biopharmaceuticals in line with the philosophy of founder Chairman, Dr C S Poonawalla. - Dr SD Ravetkar senior director, Serum Institute of India Biotech to boost agri production Last year's moratorium on Bt Brinjal has spurred the industry to play a more active role. People who value the importance of growth in agriculture believe that biotechnology will play a dominant role irrespective of temporary set back. Our policymakers are well aware of the potential of biotechnology, both genetic-enineering based or genome-based. I believe, they are going to extend full support for the development and application of biotechnology in agriculture. I believe, the increasing public-private and private-private partnerships will help finding solution to issues that are threatening the food and economic security of farmers. Many of these have evaded solution through conventional breedings. Bt cotton was success and North Zone was again flourishing with cotton trade. India rose to the position of the second biggest producer and largest exporter. If we do not harness biotechnology to find solution to this problem in time, we will be back to square one. We see a continued support to research, both to institutes and industry, so a synergy is created to accelerate growth in agricultural sector. I am optimistic that release of Bt Brinjal as first food crop is imminent and it will win the confidence of farmers and consumers alike. Company Outlook: We are better determined to disseminate the varieties and hybrids that have been improved, using GMO and Non GMO approach. Being a group committed to serve farmers and people, we are planning to partner with public and private sector in application of biotechnology. Our target is to invest more than three fold of what we have already done for biotechnology segment - Dr Govind Garg, head, R&D, Krishidhan Seeds CROs to see big boom Over the last decade, rising pressure to reduce costs and time-to-market has led to a rapid expansion of the global contract research organization market. Pharma and biotech company spend on CRO services has shown double digit growth in the past years highlighting the importance of this fast growing market. CROs today are critical contributors to the drug development programs of pharma and biotech companies often resulting in substantial time and cost saving. Many CROs and pharmaceutical companies are turning to strategic partnerships to gain a competitive edge in the global business environment. Various business models are being employed to forge long-term relationships. Consolidation of businesses has turned from a trend to reality today. The CRO market, which is highly fragmented today, will see further consolidation in 2011 where small as well as large CROs will continue to merge. Company Outlook: While Dabur Research Foundation (DRF) already has the required infrastructure and competence to take a new molecule from early discovery to advanced preclinical stage of development, as a CRO our focus in 2011 will be in the following critical areas â€“ (i) develop and offer in vitro alternatives to animal testing to drug companies, especially those developing dermatological and skin care products. (ii) offer state-of-art screening strategies in oncology to companies developing drugs to treat cancer. (iii) help reduce attrition rates in drug development and thereby reduce costs by offering special drug screening modules that DRF has developed over several years of painstaking research. - Dr Manu Jaggi, CEO, Dabur Research Foundation M&A, sell-offs to linger till 2012 In 2011, I expect mergers and acquisitions in the Indian clinical research industry and consolidations between Indian CROs. There are also possibilities of smaller Indian CROs selling-off their business interests to larger CROs, as the spate of consolidation is expected to continue till 2012. Company Outlook: We are looking to build upon existing capabilities in India and the US, and expand our capabilities in the UK office to allow sponsors the advantage of running studies through our UK office in both Western and Eastern Europe. - Mr SK Mukherjee, director, CliniRx Research India is in-sync with global trend I expect global companies to acquire or partner with Indian companies. There will be an increase in genomic spending by academia. The industry is very much in tune with global trends. The number of clinical trials in India will increase, and better regulations for the industry are also expected. Company Outlook: We will be moving into our new GLP campus to increase services. Besides, we will further enhance and release the full blown RaaS (research as a service) platform to open up for collaborations. In the New Year, we will also invest in diagnostics and kits. - Ms Anuradha Acharya, chief executive officer and co-founder, Ocimum Biosolutions R&D to be the top priority Indian pharmaceutical industry has shown some very remarkable developments. Like Indian IT space, Indian pharma companies are now considered key for entire global development. We have lot to catch up in other biotechnology segments. But due to some critical developments, India and Indian biotech companies are being looked up now. Some very good work has also been done by several biotech companies including Advanced Enzymes. Research and development must be encouraged for next 10 years for Indian companies to emerge as next destination for biotechnology. This is indeed a â€œknowledge industryâ€? and agriculture with industrial biotechnology can help India proceed at a faster pace of growth. Our agriculture is key for national growth with green technologies. Many crop productivity is still quite low. Company Outlook: Advanced Enzymes aims to become a global company with manufacturing presence in all key economies. We plan to merge our America operations and expect to grow our exports at rapid pace. We foresee lot of opportunities there and we are optimistic about our growth. In tune with that, we are setting up an 100 percent EOU in Indore SEZ with massive capacity expansion plans - seven times bigger than our present plant in two steps. Our first plant with double capacity is expected to become operational by mid-2011. If every thing goes well, we expect to cross our exports alone over $20 million (1billion) in 2011-12.â€? - Dr CL Rathi, managing director, Advanced Enzymes Non-urban demand for healthcare rises Healthcare demand and availability in non-urban areas will go up considerably. The increasing educated patient population is posing huge demand for improved health services, and a more focused approach to personalized healthcare. Company Outlook: We will leverage the breadth of our portfolio and market leadership to bring quality in in-vitro diagnostics, personalized healthcare. We are also looking at bringing new technologies, such as, sequencing and microarray into diagnostic arena. - Dr Bhuwnesh Agrawal, managing director, Roche Diagnostics It's the time to expand operations Company Outlook: We are looking to expand coverage of our foot & mouth disease program from 64 districts to 121 districts, a significant increase from $25 million (110 crore) to $50 million (220 crore). We are also doubling milk production by spending lot more on nutraceuticals. Currently we have 15 percent share of the 2,000 crore health market. We are working on NDTB and have also partnered with Indian Vaccine research Institute. We also expect 60-70 percent share in the cattle and sheep vaccine industry.so looking at bringing new technologies, such as, sequencing and microarray into diagnostic arena. - Mr KV Balasubramaniam, managing director, Indian Immunologicals A mix of innovation and right policies India is uniquely positioned to become a leading global biotechnology centre. India’s success in biotechnology will depend largely on how it implements policies for biopharmaceutical products that balance innovation and competition, and make patient safety and product quality paramount considerations. Company Outlook: We are commited to improving the lives of patients by transforming scientific discovery into health care guides. In 2011, our focus would be to increase awareness about Multiple Sclerosis (MS) in India, be an integral part of the health care system in treatment of MS and enable neurologists to provide meaningful solutions to their patients. Our goal is to expand the Biogen Idec drug portfolio in India and launch more products for Indian patients; we currently have AVONEX and Tysabri for the treatment of MS. We have made significant investments in India, both on the R&D as well as on the commercial front. We have already integrated our India operations into our global drug development strategy and investments and plan to continue to enhance that in the coming months and years. Our high caliber India team is well-poised to make significant contributions in developing and growing this exciting field of biotechnology in India. —  Dr Alpna Seth, chairman and managing director, Biogen Idec --------------------------------------------------------------------------------------------------- Innovation to play a major role The growth of biotech industry is dependent on extraordinarily high investments and long incubation times. For the industry to sustain and become globally competitive in the future, the focus will be on rapid innovation and effective R&D management, collaboration and to explore opportunity for contract manufacturing. Value creation through generation of strong pipelines leading to robust intellectual property portfolios will be a big play in the future. There will be increased spend on R&D and innovation, as more Indian companies undertake new product development, increase in M&A activity and more importantly product/franchise acquisitions by MNCs in India. Company Outlook: Bharat Biotech’s focus is to consistently innovate, bring out new molecules and vaccines to serve the 5.8 billion emerging market. Our immediate goal is to bring out at least one ‘made in India’ molecule. Bharat Biotech has delivered over one billion doses of its vaccines. Our aim is to double the number in the next five-to-six years. We are also investing substantially in R&D, clinical trials and to add new facilities, including expansion of our existing facility to meet the growing demand for our range of products. In our new product pipeline, we have made significant advancements in the development of vaccines for Malaria, Rotavirus, Japanese encephalitis, Chikungunya, Typhoid-conjugate, and therapeutics for myocardial infraction, wound healing, and Staph Aureus (MRSA). We are also on target to file an IND with the USFDA for a novel biotech moleculein 2011. —  Dr Krishna Ella, chairman and managing director, Bharat Biotech --------------------------------------------------------------------------------------------------- Investors increase biotech focus As the world economy recovers from downturn, the investor community will increase its focus on biotechnology. India is beoming a big market for pharma/biotech products, Indian biotech firms are also looking beyond borders to expand their market. This will lead to more partnerships between Indian and international players, similar to the one we saw between Biocon and Pfizer recently. Growth is predicted in agri-biotech, biopharma, oncology products, vaccines and new therapies such as regenerative medicine (stem cells). Systems and predictive biology segment is poised to grow in India too. Association Focus: The prime motivation of ABLE is to play a catalytic role for the growth of the Indian biotechnology industry. We will continue to be the platform for all the the stakeholders, (industry, government, academia) of this sector to interact, connect, deliberate and partner. One of our main focus will be to intensely engage with the government to streamline regulation be in biopharma, bioagri, diagnostics & devices, improve access to early stage funding schemes and continue the dialogue on various issues that affect the industry. —  Dr Satya Dash, chief operating officer, ABLE Nayantara Som & Rahul Koul ]]> <![CDATA[EMD Millipore introduces new kit]]> https://biospectrumindia.com/news/95/4599/emd-millipore-introduces-new-kit.html https://biospectrumindia.com/news/95/4599/emd-millipore-introduces-new-kit.html Thu, 09 Dec 2010 15:58:00 +0530 EMD Millipore, the life sciences division of Merck of Germany, has introduced a rapid kit for bisulfite conversion, which is a critical first step in mapping the differences in genomic DNA methylation patterns. Aberrant DNA methylation can result in inappropriate activation or silencing of specific genes, and is associated with errors in embryonic development as well as the onset of diabetes, cancer, cardiovascular, and other diseases. The new CpGenome Turbo kit reliably converts unmethylated cytosines to uracil in 90 minutes, which is twice as fast as commonly used bisulfite kits and reagents. By increasing throughput of bisulfite modification, CpGenome Turbo kit allows researchers to examine DNA from more samples in less time. GE Healthcare launches ÄKTA avant 150 GE Healthcare, a global biosupplier company, has launched ÄKTA avant 150, the second system in the new generation of ÄKTA liquid chromatography systems. ÄKTA avant 150 complements the ÄKTA avant 25 system to fully exploit the advantages of modern bioprocess media, enabling smooth development of scalable chromatographic processes for biopharma production. With flow rates up to 150 ml/min, the ÄKTA avant 150 is designed for process development and scale up. The UNICORN 6.1 control software enables seamless method transfer between ÄKTA avant 25 and ÄKTA avant 150. UNICORN 6.1 also comes with integrated Design of Experiments (DoE) functionality that provides time and cost savings, by capturing the information required for decision making in fewer experiments. Agilent upgrades bioinformatics software Agilent Technologies has introduced GeneSpring GX 11.5, an expansion of its popular bioinformatics software into visualizing and analyzing multiple types of biological data. GeneSpring GX 11.5 interprets exon microarray, proteomics and metabolomics experiments together for the first time, using a familiar interface. These new capabilities join existing GeneSpring GX applications for gene expression analysis, genomic copy number analysis, genome-wide association analysis and transcriptomics data analysis. ]]> <![CDATA[Biofuels set for a Sea-Change]]> https://biospectrumindia.com/news/95/1964/biofuels-set-for-a-sea-change.html https://biospectrumindia.com/news/95/1964/biofuels-set-for-a-sea-change.html Thu, 09 Dec 2010 15:54:00 +0530 Oceans have the potential to be the largest farm for biofuels. A new wave of investment in marine biofuels is gaining momentum as the world is looking for a reliable replacement for fossil fuels Seventy percent of the earth’s surface is covered by salt water which provides breeding space for all varieties of seaweeds. For centuries, China and other Asian countries have grown seaweeds — also known as macro-algae — for food, animal feed, pharmaceutical remedies and cosmetic purposes. This expertise gives Asian countries the advantage of the benefits of marine algae as a biofuel. Both micro and macro algae are used for extraction of marine biofuels.   Algae Advantage Marine biofuel, which is considered third generation biofuel, has many advantages that make it preferable over first and second generation biofuels, that are derived from sources such as starch, sugar, animal fats and vegetable oil; and lignocellulosic crops respectively. According to the algae market study, Algae 2020, the seaweed grows faster than terrestrial crops; has high sugar content for conversion to advanced biofuels and ethanol, absorbs more airborne carbon than land-based plants, has no lignin, can be easily harvested, requires no pretreatment for ethanol production, and can be harvested up to six times a year in warm climates. “The bioenergy demand is increasing exponentially. Increasing fuel prices encourage biofuel research. Organization of the Petroleum Exporting Countries (OPEC) too has plans to reduce oil production. If the price of fuel goes beyond 4,500 ($100) per barrel, then it is time to consider alternate sources. As opposed to first and second generation biofuel production, algae-based biofuel production is the efficient way to get long-term result,” says Choul-Gyun Lee, professor, Department of Biological Engineering, Inha University, South Korea. Commenting on the advantages of marine micro algae, Dr Dinabandhu Sahoo, secretary, Indian Phycological Society, Marine Biotechnology Laboratory, Department of Botany, University of Delhi, India, says, “Marine algae have several advantages. They do not need fresh water — as algae can grow in sea water — it is environment-friendly as it alleviates acidification of the ocean, it can be cultivated on a large scale; provides employment to coastal population, and the byproducts from algae can be used in food, pharmaceutical and nutraceutical industries besides use as biofertilizers.” “As opposed to first and second generation biofuels, algae-based biofuel production is the efficient way to get the benefits for a long-term”  — Choul-Gyun Lee, professor, Department of Biological Engineering, Inha University, South Korea APAC Market Scenario After a significant presence in first and second generation biofuels, countries in Asia Pacific region are now shifting focus to third generation biofuels. According to the report released by APAC Biofuel Consultants, Australia’s biofuel capacity is expected to go from 636 million litres in 2010 to 1.5 billion litres by 2015. In order to achieve this goal, the country promotes marine biofuel companies. The collaboration between companies is the way to achieve the target. Recently US-based algae biofuel developer, Aurora Algae announced expansion plans in Australia, by opening new regional headquarters in Perth (Western Australia) and ramping up commercial operations in the region. South Korea has pledged about 1,200 cr ($275 million) to develop macro-algae biofuel capacity, over the next 10 years. They hope to be able to produce 400 million gallons of ethanol from macro-algae, which would replace 13 percent of their fuel demand. The project will create an offshore seaweed forest of approximately 86,000 acres in size. “South Korea is the world’s fourth largest oil importer and the world’s seventh largest oil consumer. South Korea’s foreign energy reliance is 97 percent, that is, nearly all the energy South Korea consumes is imported. Thus, the economy and national security of South Korea greatly depends on foreign energy. The South Korean government is also planning to support bioethanol-related technology development projects, in order to boost energy efficiency, and will also launch a bioethanol quality monitoring system, before putting it to commercial use,” says Myungkyo  Shin, CEO & vice president, Biolsystems, South Korea. The Philippines government has allotted 23 crore ($5 million) to develop a 250-acre seaweed-based ethanol plant and aqua farm cluster. The aqua farms will be located in four places, and will utilize South Korean ethanol; extraction technology, developed at the Korean Institute for Industrial Technology. South Korea-based Biolsystems is expanding operations in the Philippines. The company is checking seaweed (red algae) farms in the coastal towns of Bohol in the Philippines, to determine if the area can supply adequate raw materials for the processing of bio-ethanol, and the quality of seaweed grown in these areas.   In the context of international perspectives and national imperatives, the Ministry of New and Renewable Energy (MNRE), Government of India, formulated National Policy on Biofuels in December 2009. The policy, approved by the Cabinet envisages development of next generation, more efficient biofuel conversion technologies, based on new feed stocks. Through this policy, India has set an indicative target of 20 percent blending of biofuels, both for bio-diesel and bio-ethanol, by 2017. India has great potential in algae biofuel, as it can utilize its 7,000 km of coastal line, and the country is intensifying research activities. India-based seaweed cultivation company Aquagri, along with Central Salt and Marine Chemical Research Institute (CSMCRI, Bhavnagar) is part of a European Union-funded project on marine micro algae, Biowalk4biofuels. The company will use the expertise gained through the partnership, to venture into marine biofuel production, says Abhiram Seth, managing director of Aquagri. “Asia Pacific region has the tropical advantage as algae need more sunlight. APAC countries have already gained awareness about the immense potential of algae biofuels. International events like UNESCO’s Global Conference on Oceans, Coasts and Islands in Paris; and International Marine Biotechnology Conference in China; and joint R&D initiatives like the Asian Network for Using Algae as a CO2 Sink, under Asian Pacific Phycological Association (AAPA); and India-Brazil-South Africa (IBSA), a trilateral developmental initiative, are positive initiatives in that direction,” elaborates Dr Sahoo. Even global automobile majors like Ford Motor Company, US are promoting research on exploring algae as an alternative biofuel. The US House of Representatives passed the Green Jobs Act of 2010. The Act offers investment tax credits for algae-based bio-refineries. APAC countries need algae-specific policies like this, to intensify the growth of marine biofuel research and commercialization. Increasing levels of pollution and depleting levels of fossil fuels are driving the need for renewable biofuels. If marine biofuel can fulfill the huge demand for biofuels, it is the best bet. Pradeep Kumar in Bangalore ]]> <![CDATA[Global forum for business]]> https://biospectrumindia.com/news/95/2792/global-forum-for-business.html https://biospectrumindia.com/news/95/2792/global-forum-for-business.html Thu, 09 Dec 2010 15:50:00 +0530 BioAsia 2011 brochure was released at a ceremony held recently The eighth edition of BioAsia, the global bio-business forum organized by Government of Andhra Pradesh, is scheduled for February 21-24, 2011, in Hyderabad. The event aims to provide a common platform to stakeholders and business drivers of the life sciences sector; to create synergies, share sustainable best practices, and chart a strategic way forward. The event will focus on enhancing cooperation among stakeholders through conference sessions that provide an opportunity to learn, network with peers, and share best practices. The international trade show, to be held as part of the event, will focus on showcasing the strength and influencing capacity of participating companies; B2B partnering develops private business network; the CEO conclave provides an opportunity to share the vision and ideas, in an interactive thought-leadership forum; and Bio Parks session provides the chance to visit world-class biotechnology, medical technology and agricultural biotechnology (agribiotech) clusters. A wide range of entrepreneurs including senior executives of leading biotechnology companies, business development teams from large and mid-size pharmaceutical companies, eminent scientists from R&D institutions, universities, investors besides other industry experts are expected to attend this event that will also provide an excellent platform for global business tie-ups. The previous edition of BioAsia held in February 2010, saw a participation of over 4,000 delegates from 21 countries across the globe. The event also recorded 800 onsite B2B meetings, and featured about 160 companies. ]]> <![CDATA[GEAC approval for transgenic corn trials]]> https://biospectrumindia.com/news/95/1438/geac-approval-for-transgenic-corn-trials.html https://biospectrumindia.com/news/95/1438/geac-approval-for-transgenic-corn-trials.html Thu, 09 Dec 2010 15:48:00 +0530 The Genetic Engineering Appraisal Committee (GEAC), the apex regulatory body for biotechnology-related products in India, has approved Monsanto India's request to conduct seed production research trials for transgenic corn lines. The trials - Hishell and 900M Gold (Events MON 89034 x NK 603) - will be held at Kurnool and West Godavari in Andhra Pradesh, at the company's leased land. The committee noted that the purpose of the trials is to evaluate seed production of transgenic corn lines event MON 89034 and event NK 603; under confined open field conditions, involving taking note of pollen dehiscence and flowering behavior, that would help in working out the staggering requirements for the stack hybrid development. Also, the study may help in understanding the flowering time pattern of the transgenic corn lines with event MON 89034 and event NK 603, under confined field conditions. Total required area for each location will be 0.98 acres for two plantings. Approval for GM cotton export In its 104th meeting, the Genetic Engineering Appraisal Committee (GEAC) has noted that the export of genetically modified (GM) cotton does not require its approval. The regulatory body that met on November 15, 2010 in the Ministry of Environment and Forests discussed the subject, and concluded that GEAC does not have any role in exports. The Committee noted that GEAC has been receiving a number of requests for export of approved Bt cotton events to Pakistan. The intended purpose of export is for research/field testing. The need for obtaining such approvals was discussed, wherein the Committee opined that approval from GEAC is not necessary, as it is the responsibility of the importing country to take such decisions. Therefore, export of Bt cotton seeds can be allowed, subject to the exporter obtaining approval of the competent authority of the importing country; and approval from National Biodiversity Authority, Chennai, as per the provisions of Biological Diversity Act, 2002. In view of the above stated facts, exporters are not required to obtain approval of GEAC prior to export of Bt cotton seeds, expressing approved events. However, information on export may be submitted to GEAC for records. India gears up to counter swine flu According to Union Ministry of Health and Family Welfare, the government has granted license to six pharmaceutical companies for manufacturing two drugs for swine flu treatment. Besides that, three other companies have already been permitted to manufacture vaccines for its prevention. The Minister of Health, Ghulam Nabi Azad recently made this announcement in the Parliament, stating that the drug Oseltamivir and its formulation for treatment of H1N1 (swine flu) is being manufactured by Cipla, Hetero Drugs, Natco Pharma, Ranbaxy Labs, Strides Arcolab and Cadila Pharma. Another drug for the purpose, Zanamivir, is being manufactured by Cipla. Also, for prevention of H1N1 (swine flu), licenses to manufacture influenza (H1N1) vaccine have been granted to Serum Institute of India, Cadila Healthcare and Bharat Biotech. Besides that, there is the much-awaited Pandyflu vaccine from Panacea Biotec, to be launched any time soon. Licenses for manufacture and sale of medicines in the country are granted by the State Licensing Authorities appointed by State governments, under the provisions of the Drugs & Cosmetics Act, 1940. RIBN to enhance Russia, India ties In a bid to encourage joint biotechnology initiatives between Russia and India, an agreement on Russia-India Biotech Network (RIBN) was signed and exchanged in the presence of the then chief minister of Andhra Pradesh, K Rosiah, by Prof Raif Vasilov, president, Russian Biotechnology Society & CEO, Russian Bio-industry Association; and Dr BS Bajaj, convener, BioAsia 2011 and secretary, Federation of Asian Biotech Associations (FABA). RIBN will be a dedicated online platform to effectively facilitate collaboration between the Russian and Indian biotech communities. â€œRIBN will act as a dynamic platform to bring together Russian and Indian biotechnology communities - both business and science. Later, other countries could join this platform, making it the first global professional networking system. The first phase of the platform is functional from October 2010, and it would become fully-operational during BioAsia 2011 in February 2011,â€? said Prof Raif Vasilov. The interested Russian companies will be able to browse through the profile of their Indian counterparts, and interact with them to understand their activities in detail and vice versa. â€œRIBN will facilitate business partnering throughout the year, in addition to offering business support services like databases, online seminars, placements, exchange programs, facility visits, trade delegations,â€? said Dr BS Bajaj.Jubilant clocks 988 crore in Q2 FY2011 Jubilant Life Sciences, formerly Jubilant Organosys, an integrated pharmaceutical company, and the largest custom research and manufacturing services (CRAMS) company in India, announced financial results for Q2 FY2011. In the second quarter of FY2011, consolidated revenues for the company was 988 crore, registering a growth of six percent; with international business contributing 62 percent to the top line. Revenue from pharmaceutical and life science products and services (PLSPS) was estimated at 850 crore; contributing 86 percent to the total revenues of the company, mainly driven by 11 percent growth in active pharmaceutical ingredient (API) business and 50 percent growth in dosage forms. The life science products with revenues at 657 crore contributed 67 percent and the remaining 193 crore was from life sciences services. The products business saw a good volume growth of 13 percent; and revenues visibility in the services business is encouraging though volatility persists due to slow regulatory approvals of the customers. Agri and performance polymers (APP) business witnessed a very strong growth of 29 percent in sales at 138 crore. This segment contributed 14 percent of total company's consolidated revenue. Growth was mainly driven by robust sales in agri-products, which was up 98 percent to 69 crore. In Q2 FY2011, EBITDA was 164 crore, as compared to 192 crore during the same quarter last year, with margins at 16.6 percent. EBITDA margins in PLSPS segment were at 19.4 percent and at 12.6 percent in APP segment. Net profit showed growth of 42 percent at 82 crore as against 58 crore in the same quarter last year. Panacea Biotec reports 52% growth Panacea Biotec, a leading vaccine manufacturer in India, has announced a growth of 52 percent in net turnover, at about 252.60 crore during the quarter ended September 30, 2010, as compared to about 165.80 crore for the corresponding period of previous financial year. The company noted that pharmaceutical formulations export grew by 285 percent; whereas domestic pharmaceutical formulations grew by 18 percent in this quarter. The company registered formulations segment net turnover of about 83.60 crore, as compared to about 61.10 crore, during the corresponding period of previous financial year, registering a growth of 37 percent. The vaccines export grew by 68 percent. The company further said it has registered vaccine segment net turnover of about 169 crore, as compared to about 104.70 crore, during the corresponding period of previous financial year, registering a growth of 61 percent. The company reported substantial growth of 842 percent in its profit-before-tax (PBT); at about 28.60 crore, as compared to about 3 crore, during the corresponding period of previous financial year. The company reported significant growth of 692 percent in its profit-after-tax (PAT) at about 17 crore, as compared to about 2.1 crore, during the corresponding period of previous year. Uniform code for pharma marketing Union Minister of State for Chemicals and Fertilizers Srikant Kumar Jena on November 25, 2010 announced that Department of Pharmaceuticals (DoP) is currently examining the possibility of framing a Uniform Code of Pharmaceutical Marketing Practices, which would be adopted voluntarily. This comes after recent reports in the media claimed unethical marketing practices of certain pharma companies. Keeping in view seriousness of the allegations made in the media reports, the DoP felt the need to take up the matter in the interest of consumers, as such promotional expenses extended to doctors had direct implications on the pricing of drugs and its affordability. After discussing the issues with pharmaceutical associations and industry, the department has been able to persuade most of the associations to have a code of ethics. Organization of Pharmaceutical Producers of India and Indian Drug Manufacturers' Association have informed that, they along with Confederation of Indian Pharmaceutical Industry, Federation of Pharma Entrepreneurs, Indian Pharmaceutical Alliance and SME Pharma Industries Confederation have worked out the 'Uniform Code of Pharmaceutical Marketing Practices'. Bioeconomy workshop stresses on global ties The bioeconomy concept involves a systematic approach to exploit information on biological systems for a sustainable production of renewable raw materials, for use in different economic sectors. Keeping that in view, a two-day workshop on bioeconomy was organized jointly by Government of India's Department of Biotechnology (DBT), and Germany-based Bioeconomy Science Center (BioSC) on November 23-24, 2010, in New Delhi. This Indo-German partnering workshop aimed at introducing Indian partners from academia, industry and stakeholder groups; to the bioeconomy concept, and its realization by the BioSC, to gain valuable insights into the Indian version towards this topic, and to match interests, in order to pave the way for strategic Indo-German partnerships in bioeconomy. Collaborative R&D and future roadmap was the key topic of discussion at the event. The workshop saw a number of speakers delivering talks on the different aspects of bioeconomy. ]]> <![CDATA[Dr Limaye becomes SCDM chair]]> https://biospectrumindia.com/news/95/2711/dr-limaye-becomes-scdm-chair.html https://biospectrumindia.com/news/95/2711/dr-limaye-becomes-scdm-chair.html Thu, 09 Dec 2010 15:46:00 +0530 Dr Nimita Limaye, vice president & global head, SIRO Clinpharm, has been named chairperson of  Society for Clinical Data Management (SCDM). “I am deeply honored to have been considered for this position, and I hope that I will live up to the trust placed in me by SCDM, to drive its strategic priorities. I would like to thank all members on the board and all members of SCDM across the globe, for their support. I would never have been able to achieve this, without the steady support that I have received from my management at SIRO,” said Dr Nimita Limaye. “Considering SCDM’s global membership profile, Nimita’s achievement will definitely add a lot of value to SIRO ClinPharm, US,” said Chetan Tamhankar, CEO, SIRO Clinpharm. Sigma-aldrich CEO passes away, Rakesh Sachdev takes over Sigma-aldrich Corporation, a leading life sciences and high technology company, has announced the sudden death of Dr Jai P Nagarkatti, its chairman, president and CEO, who died unexpectedly, of an apparent heart attack. Dr Nagarkatti spent his entire career with Sigma-aldrich — beginning in 1976 — with positions spanning R&D, manufacturing, operations, sales and marketing. His effectiveness and dedication were recognized in each function; and led to steady promotions and increasing responsibilities.  He was elected president and chief operating officer in 2004; elected to the additional roles of CEO in 2006; and chairman of the board in 2009. He had been a member of the board of directors since 2005. Under his leadership and guidance, the company continued its focus on service, quality, and innovation, to become a leading global life sciences and high-tech company. His vision drove the company’s renewed focus on sustainability and corporate responsibility, touching countless persons in the company, and communities in which it operates. Sigma-aldrich’s board of directors, has had in place, a careful succession plan for key officers, including the CEO. The board has elected Rakesh Sachdev as president and CEO of the company. Earlier, Sachdev served as chief financial officer, chief administrative officer, and senior vice president of international business. Dr AS Arvind joins Ecron Acunova DA Prasanna, chairman of Ecron Acunova (EA), an India and Europe-based clinical research organization (CRO), has announced the appointment of Dr AS Arvind as strategic advisor. He will guide the company on operational excellence and will mentor the team. From his immense experience, Arvind will support the clients medically, scientifically and strategically in their clinical development plan. Prior to EA, Dr Arvind was chief operating officer of Clinigene, a subsidiary of Biocon. In 2000, he played an integral role in the development of Biocon’s pipeline and contributed to its strategic alliances with global majors. Prior to Biocon, Dr Arvind was consultant physician at West Wales General Hospital, and has held prestigious positions at UK hospitals. ]]> <![CDATA[ICMR needs to push translational research]]> https://biospectrumindia.com/news/95/7055/icmr-needs-to-push-translational-research.html https://biospectrumindia.com/news/95/7055/icmr-needs-to-push-translational-research.html Thu, 09 Dec 2010 15:44:00 +0530 Addressing a galaxy of senior scientists in New Delhi on November 15, 2010, during the inauguration of centenary celebrations of Indian Council of Medical Research (ICMR), Union Minister of Health & Family Welfare Ghulam Nabi Azad said, “India cannot wait indefinitely for development of new technologies for health, that are urgently required, to control various diseases affecting the people of the country.” Dr C Gopalan, former director general, ICMR and president, Nutrition Foundation of India, in his keynote address, urged the community not to depend on synthetic nutrients, and recommended judicious use of available food items, to control malnutrition. As challenges in nutritional security are formidable, there is a need to re-set our priorities; and also involve school children, mothers and other agencies, to spread this message. In his Foundation Day lecture, Father of Green Revolution in India, Dr MS Swaminathan, said that to counter challenges in crop productivity due to climatic changes, it is essential to develop strategies as ‘anticipatory research’. He emphasized that issues of malnutrition can be effectively resolved only with the involvement of farmers. ‘Health research for marginalized communities continues to be an area of priority for ICMR’, observed Dr Vishwa Mohan Katoch, director-general of ICMR. DBT signs MoU with UK Biotech Council The Department of Biotechnology (DBT), Government of India; and the Indian Council of Agricultural Research (ICAR), New Delhi, have signed a memorandum of understanding (MoU) with the UK’s Biotechnology and Biological Science Research Council (BBSRC) and the Department for International Development (DFID). The MoU was signed on November 12, 2010 by Dr MK Bhan, secretary, DBT, in the presence of Minister of Science & Technology, Kapil Sibal and visiting UK Science Minister, David Willetts. The letter of intent (LoI) to launch a new initiative on ‘Food Security: Sustainable Crop Production Research for International Development’ has also been signed, with the aim of underpinning scientific knowledge that will increase food security and alleviate poverty. The initiative is expected to forge productive global partnerships between scientists in the UK, India and other developing countries, to leverage high quality biological and biotechnological research, for sustainable crop production in South Asia and Sub-Saharan Africa. The total value of the initiative is estimated to be 144 crore, over a period of five years. This fund will be used to support the development of scientific knowledge, and building sustainable research capacity that will benefit emerging economies and the developing world. The LoI will subsequently be followed up by a joint call for proposals on sustainable crop production, that will be open for research proposals from international teams of scientists from India, the UK, South Asia and Sub-Sahara Africa. Sibal and Willetts reiterated the commitment of their respective countries towards closer cooperation and a cohesive relationship in this area. They hoped that the collaboration on global food security would harness the expertise available in the UK, India, sub-Saharan Africa and South East Asian region. Novozymes opens new R&D center Novozymes, one of the world’s largest producers of industrial enzymes, has opened its new state-of-the art R&D center and office in Bangalore. Steen Riisgaard, CEO, Novozymes, inaugurated the new center that will house the India operations, including global support services and the R&D center. The R&D center will undertake protein engineering work for Novozymes’ global requirements; and will act as a resource base for the company’s global discovery projects. The center will also serve as an application technology excellence center for Novozymes’ global juice and wine industry requirements. The center is actively innovating food applications for the Indian market, by undertaking research to understand local needs in India. OSDD to receive 183 cr fund The Open Source Drug Discovery (OSDD) project of the Council for Scientific and Industrial Research (CSIR) is set to receive another financial boost. While pledging the support of the government to innovation, Prime Minister, Dr Manmohan Singh emphasized that government is committed to raise around 183 crore in funding for OSDD, from international agencies and philanthropists. Dr Manmohan Singh while giving away the Shanti Swarup Bhatnagar prize for exceptional contribution in the field of science, at a ceremony in New Delhi, said, “The Government of India has committed around 183 cr to this project, and is now committed to raise an equivalent amount of funding for OSDD, from international agencies and philanthropists.” ]]> <![CDATA[Algae biofuel will takeover jatropha soon]]> https://biospectrumindia.com/news/95/5676/algae-biofuel-will-takeover-jatropha-soon.html https://biospectrumindia.com/news/95/5676/algae-biofuel-will-takeover-jatropha-soon.html Thu, 09 Dec 2010 15:38:00 +0530 It is estimated that by the year 2012, nearly 13.38 million tons of biodiesel will be produced, using nearly 13.4 million hectare of land across India. But the target for jatropha, a non-native plant, could not be achieved because of several constraints Dr Dinabandhu Sahoo, secretary, Indian Phycological Society, Marine Biotechnology Laboratory, Department of Botany, University of Delhi, New Delhi Worldwide energy demand — particularly for transportation-based fuels — contin-ues to rise. As per International Energy Agency's World Energy Outlook, if usage of energy continues in the same way, then the world will run out of all energy reserves by 2099. Again, if the energy consumption rate for all other countries reaches the level of the US, then we would run out of energy by 2048. Growing Demand According to Oil and Gas Journal estimates, worldwide energy reserves at the beginning of 2004, were 1.27 trillion barrels of oil and 6,100 trillion cubic feet of natural gas. At today’s consumption rate of 85 million barrels per day, the oil reserves will perish much sooner than expected. More than 100 billion gallons of fossil fuel is consumed by the US alone. The US currently imports approximately two-thirds of its petroleum; 60 percent of which is used for producing transportation fuel. Because of this depleting oil resources and the concern over climate change, biofuels such as biodiesel and bioethanol, have attracted attention in the past several years. European Union has been the leader in biodiesel production, followed by the US. Several other countries like Brazil, Argentina, China, Indonesia and Malaysia are expanding their production capacities. Around 10 billion liters of biodiesel were produced in 2007 — an 11-fold increase since 2000. The global biodiesel market is estimated to reach 37 billion gallons by 2016; with an average annual growth of 42 percent. Sources of Biofuels Currently, many types of vegetable oils like soybean oil, palm oil, sunflower oil, rapeseed oil, waste cooking oil, animal fats are extensively used for biodiesel production. Food crops like maize, corn, sugarcane are extensively used for bioethanol production. This has not only led to greater debate on ethical issue like food versus fuel, but also on the extensive use of water for crops. Because of these problems, other non-edible oil resources like jatropha, pongamia, castor, are now gaining attention as alternate biodiesel crops. Although substantial investment has been done in jatropha, results have not been encouraging, commercially. Now, globally, it has been demonstrated that algae can be a potential source of both biodiesel and bioethanol, as it does not compete with food; and can be grown in waste water or saline water. Indian Scenario Due to limited domestic crude oil reserves, India imports around 70 percent of crude oil. India’s biofuels program is centered on bioethanol from sugarcane molasses and biodesel from non-edible crops. The Government of India approved the National Policy on Biofuels in December 2009, which envisages an ambitious plans. Drawbacks of Jatropha The Government of India’s Biofuels Committee submitted a report in April 2003, in which it found that jatropha curcas is the most suitable species for biodiesel, because of several advantages like: ❖ Ability to grow in degraded wasteland having low rainfall of 200 mm/year. ❖ Easy to plant, grow and collect, without fencing. ❖ It is possible to integrate jatropha plantation with social forestry and poverty alleviation. ❖ Byproducts can be used for manure and biogas production. ❖ Average planting density of 2,500 trees/ha, with average oil contents of 30-35 percent, average seed production 3.75 tons/ha, average oil yield of 1200 kg/ha. It was estimated that by 2012, nearly 13.38 million tons of biodiesel will be produced using nearly 13.4 million hectare of land across India. But the target for jatropha, a non-native plant, could not be achieved because of several constraints: ❖ Land has been an emotional issue in India. Unavailability of large stretch of land, issues related to ownership rights, complexities in land holding laws are creating issues. ❖ Long gestation period of up to five-to-six years. The marginal farmers cannot wait for such a long period. Most of the farmers feel that jatropha cultivation is not rewarding. ❖ Initial inputs of fertilizer, irrigation, pesticides and labor cost for pruning are very high. ❖ Variation in seed yield, oil contents and price structure. Besides government agencies, several large and small private sector players have entered jatropha cultivation projects, but many of them closed down due to several factors. Advantage Algae Algae offer a variety of approaches starting from carbon dioxide capture from the source, and converting it not only to biodiesel and bioethanol, but also various other valuable products. Algae require less land areas for growth; can be cultivated in waste, brackish or saline water. They can be grown in a wide range of temperatures and varied environmental conditions. For the production of one million gallon/year of biodiesel, specialized algae will require less than 100 acres of land; where as jatropha needs 4,500 acres and soybean requires 16,000 acres of land. Till date, about 4,600 crore ($1 billion) has been spent for developing algal biofuel. A large number of companies and venture capitalists have invested heavily in algal biodiesel projects. In 2010, the US Department of Energy announced about 3.7 crore ($80 million) in funding for research in algae-based biofuels. Exxon Mobil and Synthetic Genomics have announced a massive investment of about 2,700 crore ($600 million) for Algae Biofuel Project. One of the major focuses of the present US administration is to be self-reliant on oil production, from strategic point of view. Thus, as per the US Naval Task Force on Energy, by 2012, all ships and aircraft on demo group are to be certified to run on 50 percent biofuel blend. By 2016, each ship will contain full load of biofuels. The US and EU are leading investors in biofuels. Since the investments are huge, the companies operating in these regions have kept the production facilities completely confidential. Huge investments have gone into strain improvements program, photo bioreactor designs and intellectual property rights (IPRs). In the long run, these overseas companies will develop production technology and business models, then license the production technology to developing countries at a high price, making biofuel production from algae, economically unviable. Thus, efforts are being initiated to set up algal biorefineries, to get multiple products from the same strain of algae. The biofuel industries in the US have already set up an algal biomass organization and their counterpart in Europe has set up a similar body. Besides using algae for biofuel, they are being used as food, feed, fertilizers. Marine algal extracts like agar, carerageen and alginates are extensively used in ice-cream, toothpaste, medicines, beauty products, soap, shampoo, textile printing, beer refining, juice, chocolate making, flavored milk, meet processing, packaging, bakery products, pet foods, sanitary napkins, air freshener, tissue culture media and a large number of other industries. Today, marine algae market is valued at about 320 crore ($7 billion). Realizing the huge potential of algae in the future, the author has developed and implemented the “First All India Coordinated Project on Large Scale Algae Cultivation in India”, with the help of the Department of Science & Technology, Government of India. A major initiative has been adopted at the international level through “Asian Network for Using Algae as a CO2 Sink”, comprising researchers from 10 different nations led by South Korea. The author represents India in this vital group. The investment in algal biofuels is growing rapidly. But we need the right combination, right people and right approach to make it a success. Algae biofuel is soon heading to be a booming industry. Now is the time to act, and the Indian government and industries have to take note. ]]> <![CDATA[Avantor acquires RFCL]]> https://biospectrumindia.com/news/95/2319/avantor-acquires-rfcl.html https://biospectrumindia.com/news/95/2319/avantor-acquires-rfcl.html Thu, 09 Dec 2010 15:36:00 +0530 Avantor, a US-based manufacturer of chemistries and materials used in biotechnology and pharmaceutical production, has acquired Indian firm RFCL from ICICI Venture. Avantor, previously known as Mallinckrodt Baker, was acquired by an affiliate of New Mountain Capital, in August 2010. Avantor and its subsidiaries, manufacture and market high-performance chemistries and materials globally, under two well-known and respected brand names, JT Baker and Mallinckrodt Chemicals. Headquartered in New Delhi, RFCL is a leader in laboratory reagents and consumables, as well as products for the medical diagnostics market in India. Through its Rankem division, RFCL offers over 20,000 different laboratory products to over 5,000 customers across a variety of industries including pharmaceuticals, biotechnology, research organizations and educational institutions. RFCL’s Diagnova division offers approximately 2,000 products used by over 6,000 customers; primarily in Indian in vitro diagnostics, medical devices and life science research markets, which cater to hospitals, pathology laboratories and blood banks. Avantor identified RFCL as an attractive target to build on its current presence in the laboratory and pharmaceutical markets in India. Agilent, Wyss in technology deal Agilent Technologies and Wyss Institute for Biologically Inspired Engineering at Harvard University, US, have reached an agreement to work together to develop innovative tools, technologies and instruments that will advance human health and improve the environment. Under the multi-year agreement, Agilent will provide financial support, unique tools and materials to support Wyss’ biomaterials evolution, programmable nanomaterials and biomimetic microsystems platforms. Agilent will also contribute its technical expertise to the collaboration. Through its collaboration with pioneers in the fields of synthetic biology and programmable nanomaterials at the Wyss Institute, Agilent aims to identify new high-value applications and challenges, as well as to advance its already powerful technological capabilities in genome engineering and nanobiotechnology. In the emerging field of mechanobiology, this collaboration will develop new integrated force analysis and imaging capabilities that combine advanced optics and nanomechanical measurements. The goal is to provide deeper insights into the way physical forces and the mechanical properties of living tissues influence cell behavior, and contribute to the onset and progression of diseases such as cancer. ]]> <![CDATA["Life Technologies looks forward to consolidation"]]> https://biospectrumindia.com/news/95/2633/life-technologies-looks-forward-to-consolidation.html https://biospectrumindia.com/news/95/2633/life-technologies-looks-forward-to-consolidation.html Thu, 09 Dec 2010 15:30:00 +0530 —Mark Smedley, head-Asia Pacific, Life Technologies, US Indian talent is all over the world but India needs to do much to attract them back. The talent pool here needs global exposure US-based Life Technologies is in a definitive agreement to acquire certain assets of Gurgaon-based  LabIndia, a long-time distributor of its products on November 1, 2010. The transaction will enable the company to offer a more complete and complementary line of products directly to its customers. The acquisition is expected to close during the last quarter of 2010. However, Life Technologies does not expect this transaction to have material impact on its finances in fiscal 2010. Life Technologies provides customers with several cutting-edge instruments and reagents used in biological research, primarily under the Applied Biosystems and Invitrogen brand names. Since 1994, LabIndia has been a distributor of the company's Applied Biosystems products, including the SOLiDTM Sequencing system and Ambion RNA reagents. This transaction creates a full-service business; allowing the company to provide its Applied Biosystems products directly to customers along its Invitrogen portfolio, which includes GIBCO cell culture products, Lipofectamine transfection reagents, and a variety of benchtop instruments. In an exclusive interview with BioSpectrum, Mark Smedley, head (Asia Pacific), Life Technologies, shares insights on various aspects of the business scenario, acquisition of LabIndia assets and the overall biotechnology scenario in the country. Q What is the primary purpose in acquiring LabIndia? Our primary goal in acquiring LabIndia is to meet the increased demand from our customers, and to develop a more direct connection with them; serve their needs better with superior products, services and customer support. LabIndia has been a strong partner and a great steward of Applied Biosystems brand for the past 20 years. Also, the research platforms here, offer opportunities not only for instruments but also for consumables. So long, we have been functioning as two separate organizations in India with LabIndia as our trusted partner. This acquisition has given us the chance to offer a single conversation with customers. Our purpose has been to move from just selling instruments to offering solutions. In the last two-and-half-years, to build Life Technologies, we have been synergizing a lot of things between Invitrogen and Applied Biosciences, to integrate these two organizations with a focus on building a strong base for Life Technologies. Our partnership with LabIndia has been a remarkable one; but now the focus is on establishing ourselves not only as a selling and marketing organization, but consolidation of the supply chain and manufacturing business as well in India. Even though Invitrogen already has a base in India; and though we had a partnership with LabIndia, we could not  move from offering components toward solutions, without having our own base. So acquisition gives us that opportunity to establish ourselves even more strongly in India, which would ultimately benefit Indian researchers. Q How will this acquisition leverage your business in India? With this acquisition, nearly 100 professionals from LabIndia will join Life Technologies, creating a 200-person strong organization with operations throughout India. We will be retaining all these employees under a long standing agreement with LabIndia. We plan to add another new batch of 40 employees in the future; and India will be a service base for other purposes as well. We will integrate various teams and increase their interaction and sharing of intelligence. The sales team can share the intelligence with the reagent team. The primary focus will be on the sales of our own reagents to our instruments, secondary will be offering reagents to other instruments as well. Under the new organization, customers will have better access to a robust line of products that will provide end-to-end solutions in areas such as research, diagnostics and forensics, as well as greater sales, customer and technical service support.  Q What has been your revenue from India, and what are your future expectations? A significant amount of our investment is spent for training and providing facilities and best infrastructure for our employees. Also, Asia excluding Japan, contributes about 10 percent of our revenue. It is the highest growth region, with India and China moving on the growth path. Our revenue was less than five percent about two-three years ago, but over these years, we have registered tremendous growth. In Asia Pacific, India, China, South Korea and Australia are the major ones, but of these India has the fastest growth. We have used the market growth, which is nearly 20 percent; and to grow above that, is our major aim. Q What potential does the Indian market hold for you? The Indian market holds enormous potential. There are a lot of significant growth areas. India is critical for us. Not just as a service partner but also core organic Indian market is one of the major drivers for future growth. China and India have the highest growth potential. The research in molecular medicine is one of the core areas that we are looking at, as a potential area. Our good position in generics, sequencing and quantitative real-time polymerase chain reaction (Q-PCR) is in tune with the demands that arise in personalized medicine research areas. Besides that, there is a lot of outsourcing from the US to India. The US and European customers are outsourcing work to India; and therefore, we need to support contract research organizations (CROs) in India. The entire bio-production market in India offers good opportunities, with immense focus on quality. Q How do you compare Indian and Chinese markets? China and India need different strategies, but we have the same expectations from both markets. Both the governments are keen on funding research. Therefore, we see both markets as emerging ones, with tremendous opportunities for growth. On the competition from Chinese products in the market, we find them quite low-end. The quality of the product matters a lot, especially in research of diseases; and so our quality products are far ahead in the race; and match the expectations of the researchers. Q What is your next area of attention including a new product line? From a footprint perspective, we will pick up five new satellite offices, and relatively grow along those regions as well. The next 18 months will be spent mostly in synergizing the activities of the two organizations —  Invitrogen and Applied Biosystem — into one strong business, focusing on providing end-to-end solutions. We are approaching the Indian government for providing services in testing food and environment. Besides that, molecular biology diagnostics, infectious diseases, oncology will also be areas where we would like to cooperate with the Indian government, in providing our best possible services. We will also focus on developing region-specific facilities in the immediate future. We will be concentrating on the next generation sequencing capabilities, digital RT PCR, and continue to innovate in other areas as well. This year, a new flow cytometer was launched. Q What is your take on the prevailing biotechnology scenario in India? Some things that drive growth in India are research areas. Some of the emerging trends like gene therapy, stem cells, pharmacogenomics, personalized medicine, are also actively considered by the research community in India. The interesting research in synthetic biology, recombinant DNA, sequencing will drive the Indian and overseas market. Instruments and PCR markets will continue to grow. Bio-production and molecular biology will similarly keep offering new opportunities. The stem cell therapies breakthrough would be a priority. Bringing down the cost will boost the vast healthcare industry in India. Q What is your opinion on the availability of talent pool in India? India has abundance of talent and this has to be utilized optimally. Life Technologies has been using this talent to a great extent. In the broader sense, at Life Tech we have so many leaders who are Indians. The leaders in Cell Analysis business, Molecular Biology business, R&D are all Indians. Indian talent is all over the world but India needs to do much to attract them back. The talent pool here needs global exposure.  Rahul Koul in New Delhi ]]> <![CDATA[BioSpectrum Awards 2010]]> https://biospectrumindia.com/news/95/3880/biospectrum-awards-2010.html https://biospectrumindia.com/news/95/3880/biospectrum-awards-2010.html Thu, 09 Dec 2010 15:22:00 +0530 BioSpectrum Awards 2010 - Jury (L-R): Mr CSN Murthy, CEO, Aurigene Discovery, Bangalore (Industry); Dr Satya Dash, COO, Association of Biotechnology-Led Enterprises (ABLE), Bangalore (Industry); Ms Visalakshi Chandramouli, Partner, Health Care Fund (private equity), Tata Capital, Mumbai (Investor Community); Dr K Sankaran, Director, Center for Biotechnology, Anna University, Chennai - (Academic Community); Mr Hari S Bhartia, Co-Chairman & MD, Jubilant Life Sciences (Jury Chairman); Mr Pradeep Gupta, Publisher of BioSpectrum & Chairman, CyberMedia; Mr Mani Iyer, Founder, Iyerswest, Ahmedabad and ex-head of Biotech, Intas Pharma; Mr Narayanan Suresh, Group Editor, BioSpectrum; The verdict is out. And the result is applause â€“ for the industry captains who are winners of this year's BioSpectrum Industry Awards and also for the Jury members who managed this tough task in a two-hour-long deliberation. Since its institution in 2003, the BioSpectrum Biotech Industry Awards honor the achievements of the Indian biotechnology industry leaders. The Annuaal Gala Awards Nite in December, where these are given away, is the most eagerly awaited event in the industry. In November itself, the team at BioSpectrum begins to get queries like: who are the winners, can we have just a clue... and so on... and we have to play secretive. However, this year, we were running so late in organizing the Jury meeting that we ourselves had no clue. On one side, there were some guessing games on... and on the other, the team was getting heebie-jeebies about rolling out a special issue - like the one you are holding in your hands - in two-weeks flat. That was until the BioSpectrum Biotech Industry Awards Jury 2010 Jury met on November 13, 2010 in Delhi. The Jury constituted 10 members and was chaired by Mr Hari Bhartia, BioSpectrum Person of the Year 2009. So, on this sunny Saturday morning in Delhi, the Jury members began arriving at the Oberoi Hotel. The action had just begun... with exchanging greetings and small talk about big things, that suddenly, the weather in Delhi changed and it started pouring - cats and dogs. First clearance/ congestion and then this unexpected heavy downpour delayed the landing schedule of Mr Bhartia's plane. So, while the chairman for the eighth edition of BioSpectrum Awards was still on his way, the jury in right earnest, began the spadework. Mr Narayanan Suresh, group editor of BioSpectrum briefed the present Jury members on the process to be followed. Zeroing down on the possible winners via the process of elimination began... the process picked-up steam soon after the Jury Chairman arrived. Amidst debate, disagreements, agreements and good cheer, the winners became clear â€“ unanimously. The winners of the BioSpectrum Biotech Industry Awards are profiled in this special issue and are to be honored on December 17, 2010 in Bangalore. BioSpectrum salutes them for their achievements. BioSpectrum Awards 2010 jury arrives. Meets, greets and gets down to work var width = 300; var height = 200; var imgAr1 = new Array(); var rImg1 = new Array(); imgAr1[0] = "http://biospectrumindia.ciol.com/images/content/2010/dec/BSI_Jury2010-3.jpg"; imgAr1[1] = "http://biospectrumindia.ciol.com/images/content/2010/dec/BSI_Jury2010-1.jpg"; imgAr1[2] = "http://biospectrumindia.ciol.com/images/content/2010/dec/Sankaran.jpg"; imgAr1[3] = "http://biospectrumindia.ciol.com/images/content/2010/dec/Hari-Bhartia.jpg"; imgAr1[4] = "http://biospectrumindia.ciol.com/images/content/2010/dec/DSC_0024.jpg"; Next Prev for(var j = 0; j < imgAr1.length; j++) { rImg1[j] = new Image(); rImg1[j].src = imgAr1[j]; } document.onload = setting(); var slide; function setting() { slide = document.getElementById('pic'); slide.src = imgAr1[0]; slide.setAttribute("width",width); slide.setAttribute("height",height); } //Image or picture slide show using java script //slideshow function var picture = 0; function slideshow() { if(picture < imgAr1.length-1) { picture=picture+1; slide.src = imgAr1[picture]; } } function prev() { if(picture > 0 ) { picture=picture-1; slide.src = imgAr1[picture]; } } Jury at work The BioSpectrum Biotech Industry Awards Jury is a panel of eminent people, who come from diverse backgrounds - essentially representing the industry ecosystem. The panel is empowered to nominate or introduce any special category award. There are two key categories of Awards â€“ BioSpectrum Biotech Industry Awards and the BioSpectrum-ABLE Company of the Year Awards. The Jury decides on the BioSpectrum Biotech Industry Awards, which includes: the Person of the Year, Entrepreneur of the Year, Product of the Year, Life Time Achievement, and the Special Category Award. The winners of the BioSpectrum-ABLE Company of the Year Awards are decided on the basis of the BioSpectrum-ABLE Survey of the Biotech Industry. The top-ranked companies (by revenues) in each of the sectors are winners. These were published in June, July and August 2010 issues of BioSpectrum India edition. var width = 300; var height = 200; var imgAr2 = new Array(); var rImg2 = new Array(); imgAr2[0] = "http://biospectrumindia.ciol.com/images/content/2010/dec/Slideshow2-1.jpg"; imgAr2[1] = "http://biospectrumindia.ciol.com/images/content/2010/dec/Slideshow2-2.jpg"; imgAr2[2] = "http://biospectrumindia.ciol.com/images/content/2010/dec/DSC_0155.jpg"; imgAr2[3] = "http://biospectrumindia.ciol.com/images/content/2010/dec/DSC_0148.jpg"; imgAr2[4] = "http://biospectrumindia.ciol.com/images/content/2010/dec/Slideshow2-3.jpg"; imgAr2[5] = "http://biospectrumindia.ciol.com/images/content/2010/dec/DSC_0136.jpg"; imgAr2[6] = "http://biospectrumindia.ciol.com/images/content/2010/dec/BSI_Jury2010.jpg"; imgAr2[7] = "http://biospectrumindia.ciol.com/images/content/2010/dec/BSI_Jury2010-2.jpg"; imgAr2[8] = "http://biospectrumindia.ciol.com/images/content/2010/dec/Slideshow2-4.jpg"; Next Prev for(var a = 0; a < imgAr2.length; a++) { rImg2[a] = new Image(); rImg2[a].src = imgAr2[a]; } document.onload = setting1(); var slide1; function setting1() { slide1 = document.getElementById('pic1'); slide1.src = imgAr2[0]; slide1.setAttribute("width",width); slide1.setAttribute("height",height); } //Image or picture slide show using java script //slideshow function var picture1 = 0; function slideshow1() { if(picture1 < imgAr2.length-1) { picture1=picture1+1; slide1.src = imgAr2[picture1]; } } function prev1() { if(picture1 > 0 ) { picture1=picture1-1; slide1.src = imgAr2[picture1]; } } BioSpectrum Jury Award Winners 2010 ♦ BioSpectrum Person of the Year: Mr Glenn Saldanha, MD & CEO, Glenmark Pharmaceuticals ♦ BioSpectrum Entreprenuer of the Year: Dr Rashmi Barbhaiya, CEO, Advinus Therapeutics ♦ BioSpectrum Product of the Year: Cry1C bt gene by Metahelix Life Sciences ♦ BioSpectrum State of the Year: Karnataka ♦ BioSpectrum Life Time Achievement Award: Dr Obaid Siddiqui ♦ BioSpectrum Leadership Award: Dr Kiran Mazumdar-Shaw, CMD, Biocon BioSpectrum-ABLE Company Award Winners 2010 ♦ BioPharma Company of the Year: Biocon ♦ BioIndustrial Company of the Year: Novozymes South Asia ♦ BioServices Company of the Year: Quintiles India ♦ BioAgri Company of the Year: Nuziveedu Seeds ♦ BioInformatics Company of the Year: Ocimum Biosolutions ♦ BioSupplier Company of the Year: Waters India BioSpectrum BT School of the Year Winners 2010 ♦ Public Institute of the Year: Institute of Chemical Technology, Mumbai ♦ Private Institute of the Year: Jaypee University of Information Technology, Solan, Himachal Pradesh Awards Ceremony: December 17, 2010 in Bangalore For an invitation to the ceremony email: sanamj@cybermedia.co.in For sponsor enquiries: gurunathsa@cybermedia.co.in ]]> <![CDATA[BioSpectrum Awards Gallery]]> https://biospectrumindia.com/news/95/2415/biospectrum-awards-gallery.html https://biospectrumindia.com/news/95/2415/biospectrum-awards-gallery.html Thu, 09 Dec 2010 14:57:00 +0530 2003 2004 2005 2006 Person of the Year Kiran Mazumdar-Shaw Person of the Year Dr Cyrus S Poonawalla Person of the Year Dr MK Bhan Person of the Year M Ramasami Lifetime Contribution Prof. MS Swaminathan Lifetime Contribution Dr Manju Sharma Lifetime Contribution Dr NK Ganguly Lifetime Contribution Dr RA Mashelkar Entrepreneur of the Year Dr Krishna M Ella Entrepreneur of the Year Dr KK Narayanan Entrepreneur of the Year Sudhir Pai J Entrepreneur of the Year Dr Villoo Morawala-Patell Product of the Year AVADIS Product of the Year JEV Chex Product of the Year Q-Vac Product of the Year Reliance's plasma proteins State of the Year Award Andhra Pradesh Product of the Year Shantetra Leadership Award in BT Mr Kapil Sibal 2007 2008 2009 2010 Person of the Year Varaprasad Reddy Person of the Year Prof Samir K Brahmachari Person of the Year Hari Bhartia Person of the Year Glenn Saldanah Lifetime Contribution Dr Pushpa Mittra Bhargava Lifetime Contribution Prof G Padmanaban Lifetime Contribution Prof D Balasubramanian Lifetime Contribution Dr Obaid Siddiqi Entrepreneur of the Year Dr Vijay Chandru Entrepreneur of the Year Anuradha Acharya Entrepreneur of the Year Apruva Shah Entrepreneur of the Year Dr Rashmi Barbhaiya Product of the Year BIOMAb EGFR Product of the Year XCyto Screen Product of the Year Dry Tri T-stat Product of the Year CRY1C bt gene State of the Year Award Gujarat Product of the Year Reditux Special Category State of the Year Award Leadership Award in BT Karnataka Kiran Mazumdar -Shaw ]]> <![CDATA[India's cry1C gene: Pioneering agriculture]]> https://biospectrumindia.com/news/95/1966/indias-cry1c-gene-pioneering-agriculture.html https://biospectrumindia.com/news/95/1966/indias-cry1c-gene-pioneering-agriculture.html Thu, 09 Dec 2010 14:54:00 +0530 cry1c gene from Metahelix Life Sciences recieved the approval from GEAC for its use in two Bt cotton hybrids, MH5125 Bt and MH5174 Bt, in June 2009. This first commercial gene developed solely by a private Indian company offers the cotton plant double protection against two pests - bollworms and spodoptera What is cry1C gene? â€œWhen we ventured into this area, we wanted to bring out something different, with additional properties. One of the common strains of Bt that are used is Bt aizawai. A major crystalline (cry) protein involved in this strain is the cry1Câ€?, says Dr KK Narayanan, co founder and managing director, Metahelix Life Sciences. The cry1C was used first in cabbage and cauliflower; which are highly affected by the diamond-back moth. In addition to this, it has high activity against bollworms; and is also very active against the army worm, Spodoptera. When Bt cotton was commercialized initially, the incidence of Spodoptera increased drastically. Metahelix took this as an advantage, and began looking at using cry1C gene, which had activity against these leaf-eating worms. In Bt technology the first gene used, developed by Monsanto India (Monsanto) - a subsidiary of Monsanto Company, USA - was cry1Ac gene. The gene, first commercialized in 2002; mainly addresses the issue of bollworms which are of three kinds: American Bollworm (Helicoverpa armigera), spotted Bollworm (Earias vitella), pink bollworm (Pectinophora gossypiella). cry1Acaddresses American and spotted bollworms; but the pink bollworm is known to have field-resistance to this gene. There are two more players in this area: one is Nath Seeds (Nath), Ahmedabad (Gujarat), which has the technology from China. Nath has a variation of cry1Ac gene, which is based on a fusion technology. The other company is JK Agri Genetics (JK), Hyderabad (Andhra Pradesh), that had a truncated version of cry1Ac gene, called Xgene, commercialized around 2004-2005. The active part of the protein in JK's gene was similar to the active part of Monsanto's cry1Ac gene. And all of these address the three species of bollworms. The journey from development to approval The development of the cry1C gene was a long process, that began in 2001. The first step in developing the cry1C gene in the cotton plant, was choosing the best pattern of gene sequence for the protein, in order to have optimum activity. The nucleotide sequence has to be modified, to express the same protein; but with better activity and compatibility to the plant. The second is to decide whether to express the entire protein or the active portion of the protein. Metahelix decided to express only the active toxin. This was done for two reasons - one, the plant does not have to spend extra metabolic energy in expressing the whole protein; and also activity of the toxin is based on its concentration in the tissue that is, lower levels of the protein are expressed for higher activity. First Person â€œThe gene has been found to be effective against Bollworm. Though it is not yet commercialized, it has been approved by the GEAC. This approval in a way, proves its efficacy and effectiveness because to get a GEAC approval, one needs to go through rigorous evaluation stages.â€? -Nandkishore Kagliwal, Chairman, Nath Seeds â€œOne of the breakthroughs that we made, was cracking this procedure using a technique called agrobacterium-mediated transformation, using Agrobacterium tumefaciens as a vector. Once the transgenic plant was developed, a number of such transgenic yields were developed because the process of integration of this gene into the genome is in some ways randomâ€? explains Dr Narayanan. Depending on where the gene gets integrated, the activity varies accordingly - it could be very high to moderate, to low. It could also affect the agronomic performance of the gene leading to sterility, and so on. Hence, several transgenic yields were required to select the optimum event. In 2004, the hybrids were ready for field trials. Several demonstrations were set up all over the country in Maharashtra, Gujarat, and Andhra Pradesh. First station trials are done in one of the five research breeding stations - Bangalore, Attur, Aurangabad, Ghaziabad, Ahmedabad. After station trials, multi-locational trials are conducted in more than 20 stations, all over India. These locations are all managed and run by Metahelix. Then a system called Hybrid Advancement Trials (HATs) is done for both conventional and Bt hyrbids. HATs are done in collaboration with farmers. For these trials, the farmer receives only the input; and the company monitors the fields constantly. These trials took nearly three years. The hybrids needed a combination of the right amount of rainfall, temperature, and pests to get the required results. During these trials, a Supreme Court case came up, against transgenic crop. The Court put on hold all transgenic crop trials and this caused a delay of nearly two years in the product's development. The company went through several hurdles; and finally the government allowed the completion of the large scale trial in 2008, with very good results. They submitted their dossier the same year. Again, there were many issues with the biosafety trial. Finally, in 2009, GEAC gave its approval. â€œTechnology Stewardship' key to market survivalâ€? Dr KK Narayanan, co-founder & managing director, Metahelix Life Sciences Q What is next on the table for the cry1C gene? As we are testing stacks with the cry1C gene, we aim to make a breeding stack. For a breeding stack, we have events which have already been approved. The stacked cry1C gene would widen the spectrum, increase the number of modes of action, so that the insect-resistance management strategy can be addressed; and it is a unique stack combination. We are already in the final stages of testing these combinations, so that, we bring out our product as a stack, rather than a standalone gene. Q How do you plan to place the product in the market? There is a new term in the West called, 'technology stewardship', which is as important as developing the product itself. Without this, the product cannot survive in the market; and several major companies spend as much or even more on this, than product development itself. The market today for Bt cotton is close to 350 lakh packets; and the total cotton cultivated area is about 10.5 million hectares. Metahelix will focus on the States of Maharashtra, Gujarat, Andhra Pradesh, areas of Madhya Pradesh, Haryana, northern Rajasthan, southern Punjab and some areas of Dharwad (Karnataka). We want to start small with maybe 50,000 packets. Q What plans do you have for the Indian market? In India, our future aspirations would be to reach sales of about 100 lakh packets. By 2014-2015, we should be among the leaders in India, in cotton. Q Any global plans for the cry1C technology? The cry1C gene has not been commercialized anywhere else. It opens up the possibility to publicly license out the technology to the rest of the world. We will have a realistic approach, keeping in mind the regulatory procedures of various countries. The regulation is not just restricted to the cultivation; it also has to be deregulated in the countries which import the product. We would need a large resource pool to be able to do this; and we could possibly initiate some tie-ups, if the need arises. Some countries we might look at for expanding into are: South Africa, Australia and USA. We are also looking at Bangladesh for opportunities. We have received approvals for rice and maize hybrids in Indonesia and Vietnam. Martina Andrea D'Couto in Bangalore ]]> <![CDATA[A geneticist par excellence]]> https://biospectrumindia.com/news/95/7169/a-geneticist-par-excellence.html https://biospectrumindia.com/news/95/7169/a-geneticist-par-excellence.html Thu, 09 Dec 2010 14:50:00 +0530 From plant genetics to bacterial genetics, from molecular biology to neurophysiology, Dr Obaid Siddiqi's vast areas of research only projects his love for science, a thirst for individuality and a never say never attitude What would one do when a hailstorm destroys wheat crops sown for research? Repeat sowing the genetic crosses again? May be. But, Dr Obaid Siddiqi moved ahead, he had learnt enough of wheat genetics and thus gave in to his attraction of molecular biology. Not just here, but throughout his life, Dr Siddiqi exemplifies the attitude of a go-getter. Born on January 7, 1932, Dr Siddiqi is still an active researcher and has over five decades of research in fields such as plant genetics, molecular biology, behavioral genetics, neurobiology and his contribution to the enrichment of modern science is invaluable. BioSpectrum honors Dr Obaid Siddiqi, founder director of National Centre for Biological Sciences, Bangalore, with the Life Time Achievement Award 2010 for his pioneering work in the fields of microbial genetics and neurogenetics. He is synonymous with his continuing experiments on Drosophila (fruit fly), first on their paralytic mutations and then on the genetics of their chemical senses. Among others, Dr Siddiqi's early research on DNA transfer and recombination in bacteria and his work on suppression of 'nonsense' mutation in E.coli are some breakthrough contributions. Recipient of a dozen awards, Dr Obaid Siddiqi is a Fellow of the US National Academy of Sciences, considered the highest international scientific recognition for contribution to science. He initially focused on plant genetics and later in University of Glasgow, he moved on to the field of bacterial genetics. In the late 1960s he started working on Drosophila and in 1976 his team described the first olfactory mutant in the insect. For the past ten years, Dr Siddiqi has been more interested in the learning and the memory of the fruit flies. Early education Living across various districts in Uttar Pradesh, Dr Siddiqi, son of a bureaucrat, became interested in science towards the end of his schooling. But, the love for the subject grew when he was studying botany at the Aligarh Muslim University, where one of his teachers encouraged him to pursue research. Despite learning only conventional genetics, like Mendel's Law, Dr Siddiqi got involved in this branch by self-study and eventually decided to take up plant genetics. While, still at university, he went to the Indian Agricultural Research Institute (IARI) to study wheat genetics, where destiny had different plans for him. â€œAs luck would have it, at the end of the year, in a hailstorm, my crop was destroyed, all the crosses we had made from wheat were destroyed. So, I was faced with this problem of having to wait for one more year and repeat all my work. But, people at IARI advised me that as I have learned all I want to, I can move to a different lab to pursue other interests. Then, I decided to move to Glasgow,â€? reminisces Dr Siddiqi. At the University of Glasgow, he chose to do his PhD in genetics. The place, because of its contribution to the gene structure, was a scientific hub of geneticists. Thus here, Dr Siddiqi met some of his future colleagues and also gradually got into molecular genetics - the subject of his first breakthrough research. 'Nonsense' research In 1960, Dr Siddiqi moved to the US and started working with Dr Alan Garen at Massachusetts Institute of Technology (MIT), who was working on the connection between genes and proteins. Their experiments on the suppression of 'nonsense' mutation in E. coli was an important step in the understanding of chain termination in polypeptide synthesis. Building upon Dr Francis Crick's research on the existence of sense and nonsense mutations, Dr Siddiqi and Dr Garen started working on the mutations of alkaline phosphatase. â€œI noticed that there were many mutations which abolished the protein, that is, no alkaline phosphatase was made in those mutants and yet those mutations could be suppressed, which would cancel the effect of the original. As I had worked on suppressors before, I clearly recognized that many of the mutations, which cancel the effect of the nonsense mutations, were those outside the gene and yet they changed the structure of the enzyme,â€?says Dr Siddiqi. Later, when he exchanged data on the same suppressors with Dr Seymour Benzer, another molecular biologist with whom he would soon work, it became clear that mutations terminate the making of the protein and suppressors restore the completion of the chain. This gave rise to the idea that there were codons that terminate the chain and stop its synthesis. As a result, the three codons for all the nonsense mutations - UAA, UAG and UGI were found within a year or so. Back on home ground Having made up his mind early that he would return to India, Dr Siddiqi did so in 1962, after five years of research abroad. Through his acquaintance with Leo Szilard, a nuclear physicist, Dr Siddiqi landed a job at Tata Institute of Fundamental Research (TIFR), Mumbai, under the aegis of Homi J Bhabha. He was asked to set up a molecular biology group at TIFR, from scratch. â€œThere was no molecular biology group at TIFR and that was a very attractive situation for me, because I knew that if you go to a university where biology groups were already there, then you have to fit into whatever existed. Whereas here, I had to develop my own laboratory, which is actually what I wanted. This was in a sense, god sent,â€? recalls Dr Siddiqi. After setting up the lab, it was a time of transition for this researcher. The research areas he was already working on needed to be let behind so as to give way for fresh topics of experiments, which would later turn out to be his most pioneering work ever. â€œWhen I look back at it, this was scientifically the first phase in my work. I had worked on molecular and microbial genetics, genetic code, protein synthesis, structure of gene, suppression and things like that. But, two-to-three years after setting up the lab, I realized that many other people in the world were already doing the things we were trying to do, and sooner or later bacterial genetics would no longer be an area where we could compete, because we were likely to be left behind,â€? says Dr Siddiqi. He was extremely attracted to the ideas his friends were advocating that one should turn from molecular genetics to neurobiology, because in studying the brain of animals you could use genetics in the same way as it was used in molecular biology. Thus, started the research on Drosophila Melanogastor. Tales of the fruit fly Dr Siddiqi decided to work with Dr Seymour Benzer on neurobiology and so, took a two-year sabbatical from TIFR. With no knowledge on the subject or on Drosophila, he went to MIT, where he was visiting professor, to learn about neurophysiology and electrophysiology. After a year, he moved to California Institute of Technology, where he worked in Dr Benzer's lab on temperature-sensitive paralytic mutations of fruit fly. For a year-and-half, he was interested in and worked on genes, which control the function of the insect's nerves and muscles. First Person â€œDr Obaid Siddiqi is a deep thinker, a scientist who has made major contribution in bacterial genetics and in behavioral neurobiology and an outstanding institution builder. India is very fortunate to have him, first in ushering in molecular biology at the TIFR, then in developing developmental biology and neurogenetics there and later in establishing the National Center for Biological Sciences of TIFR. He is a role model for scientists and colleagues, but one who is impossible to emulate! All of us at NCBS are very pleased to have this award conferred on Prof Siddiqi.â€? -K Vijay Raghavan, director, National Center for Biological Sciences, Bangalore â€œDr Obaid Siddiqi was a strong influence in getting non-biologists, especially young researchers, interested in molecular biology and genetics during 1960s & 1970s. One of his talks to physicists in 1963 on the nature of the genetic code was so lucid & exciting that it got many of us interested in molecular biology. He influenced the research scene in Indian molecular biology during its infancy. A very good example of such a case is that of Prof K Vijay Raghavan, the director of NCBS. Over a period of three decades when Dr Siddiqi was at the helm, he has been able to put MBU at TIFR, on the world map. He has been one of its chief architects.â€? -Dr Padmanabhan Babu, Biotools Technologies, Bangalore â€œWe found a set of genes, which cause temperature-sensitive paralysis and what these have to do with the channels in muscles and nerves, through which ionic current is conducted and signaling of nerves take place. By electrophysiology, we found that drosophila's muscles and nerve conduction were blocked. I consider this as the first significant discovery and many other labs started working on this paralytic mutations,â€? says Dr Siddiqi. Later, when he returned to India, Dr Siddiqi realized that many people started working on the same topic and he understood that it was difficult to compete with them sitting here in India. Deciding to retain his individuality, he started to work out the connection between olfaction, immunology and neurobiology. Soon, he was working on sense of smell of Drosophila, discovering the mutants, and since then he has remained in that field. His first paper on olfactory mutants of Drosophila was published in 1978 and in two years he discovered the first olfactory mutants. His team initially worked on molecular biology of olfaction looking for olfactory receptors, mechanisms and later combined behavior genetics. These discovered mutants were later sequenced. His ongoing research focuses on learning and memory of drosophila, which like humans, can be trained to be attracted or repelled by chemicals. â€œOnce you train the fruit fly, then you can ask the question, how long it can remember its training. Just like higher animals, they have memory of various kinds like short-term and long-term memory and that is what we do now,â€? says Dr Siddiqi. Dr Siddiqi and his team's work has led to a lot of other sciences. They were the first to develop methods for measuring olfactory response and methods for doing electrophysiological recordings from Drosophila's brain. Their work has had many technical implications, been used by other people and has influenced various other research. Dr Siddiqi is married to Dr Asiya Siddiqi, a historian, and they have four children - two sons and two daughters. One of his sons has followed Dr Siddiqi's foot steps to become a geneticist and, he now works at Centre for Cellular and Molecular Biology, Hyderabad. Dr Siddiqi loves to spend his free time listening to Indian classical music. In his early days, Dr Siddiqi wanted to be a professional photographer and despite life having different plans, he is pursuing his passion for photography. 'GM crops need objective examination' Dr Obaid Siddiqi, founder director, National Center for Biological Sciences, Bangalore Q How are the US and India different as research bases? What is lacking in India is not money or support. There is a shortage of good talent here. It is easier to get people in the US because people from all over the world are ready to move there. But, here it does not work that way, we have to look for good talent and then convince them that if they come here they can work more or less in the same way as in the US. Q What is your take on genetically modified (GM) crops? I believe that plant and animal genetics can make a difference to agriculture and its production. As a geneticist, I think one cannot say all GM crops are good or all GM crops are bad. Things should be examined more objectively and see what is good for the society, environment, even economy and biodiversity. On one hand, the problem is those who want to sell GM crops do not worry about these things and on the other hand, those who oppose it claim everything that is genetically engineered, is bad. I think there has to be something in between. Q What are your views on the Indian biotechnology industry? Biotechnology industry is growing fast. Apart from the big companies, a number of small companies, those started by people who were working in research institutes, are also doing very well. These small companies have developed their own research labs. People keep complaining that the existing research labs do not do things which can be used by the industries. I think, it is important for them to be close to the industry, so that they each know what the other is doing. And this connection is visibly useful in the pharmaceutical industry. Q Currently, what kind of students do you train? I have just one or two degree students. I have 8-10 visiting scholars and post docs. Many universities in South India, such as VIT, SASTRA, are smart enough to see that they do not have necessary facilities for teaching students, how to do experiments. So, they freely give them six months or so to go out and work at other institutions and I get many such students. From my point of view, if I get four-five such persons, it allows me to see how they are and how they work and if some are good, I ask them to come back. Q Are students coming to NCBS interested in a research career or in industry? People coming to us are more interested in teaching and research or they want to go abroad after their PhD. A majority of those here go to research institutes. Now this might change, as I hear people say that lot of them are coming back to India. My hope is more and more people who are learning to do research will continue to do it here. Right now, it is not a pretty situation, because we are not able to retain the people we train. Shruthi Ram in Bangalore ]]> <![CDATA[Taking untrodden path for success]]> https://biospectrumindia.com/news/95/1851/taking-untrodden-path-for-success.html https://biospectrumindia.com/news/95/1851/taking-untrodden-path-for-success.html Thu, 09 Dec 2010 14:44:00 +0530 The son of a cardiologist, Dr Rashmi Barbhaiya opted not to tread his father's footsteps and entered the arena of pharmaceuticals pursuing higher education in clinical pharmacology. More than two decades later, the father proudly describes his son's achievement: â€œAs a doctor I can treat about 20 patients a day; while Dr Rashmi's work, with such a strong base in pharmaceutical R&D, can help save the lives of millionsâ€? When one throws a ball at the wall, it rebounds. But the force with which it rebounds depends on whether the ball is hard or soft. If it is tennis ball then the force will be more. The exit of Dr Rashmi Barbhaiya from Ranbaxy in 2004 had similar situation, as he was pushed to the wall with nowhere to go. Like a tennis ball, Dr Barbhaiya, with extensive global experience in handling diverse aspects of drug discovery and development at Bristol-Myers Squibb, USA and leading a team of over 900-strong scientists at Ranbaxy, bounced back with the same or greater force. The support and encouragement of his colleagues - Dr Kasim Mookhtiar and Sanjiv Kaul - led to the setting up of Advinus Therapeutics in 2005. â€œI started Advinus at the right time, right environment; backed by the right set of people,â€? says Dr Barbhaiya, who left India as a student to the UK to pursue doctoral studies, over 35 years ago. This graduate in biochemistry from MS University, Baroda, later landed in the US following the advice of his guide in the UK. â€œHence the journey for Advinus became smooth; to achieve the goal to explore novel targets in selected diseases areas with no API, no generics, no manufacturing, no sales and marketing experienceâ€?. Advinus' Pharma Development Bangalore operation, located on a 8-acre campus with 220,000 sq ft of modern facilities, offers end-to-end pre-clinical to early clinical development platform for pharma product development The leadership team (with over 160 years of combined working experience in large pharma companies in the US) and the Board, also shares the same mindset. Advinus, as Dr Barbhaiya adds, is the abbreviation for â€œAdvantage India US.â€? In a short span of five years, the company has achieved many milestones. Advinus has emerged as a leading partner of choice for multinational pharma companies like Merck, Novartis, Johnson & Johnson, Genzyme, DNDi besides others; for drug discovery activities. â€œI really did not have a plan to turn an entrepreneur. Stars were aligned for me to do something out of the ordinary,â€? says Dr Barbhaiya, commenting on his entrepreneurial journey. This only son of a physician from Ahmedabad (Gujarat) is a late bloomer as an entrepreneur, starting Advinus when he was in his early fifities. â€œPharmaceutical research and development was never India's forteâ€?, he says. He did not know that he would move to India. Driving forces Recalling his career at Bristol-Myers-Squibb from 1980, he calls them the fantastic 21 years that gave him over two decades of highly productive stints in the industry. During that time, Dr Barbhaiya was actively developing drugs in-house in many areas like antirectoviral, a number of drugs for AIDS, cancer, depression and anxiety, hypertension and congestive heart failure (CHF), diabetes besides many infectious diseases. He is proud to say that during that time, the company launched many drugs. He is also one of the rare industry professionals who has authored nearly 150 scientific research papers. Although he never thought of returning to India, the changes taking place in BMS during 2000, led him to opt for an early retirement, at the age of 49; and start consulting services. He could not resist the offer from Ranbaxy Laboratories; and moved to India in 2002, along with a couple of former colleagues - Dr Kasim Mookhtiar and Sanjiv Kaul. He joined Ranbaxy Laboatories as president of R&D, and led a team of over 900 professionals involved in generic, drug delivery, herbal and innovation-driven new drug research and development activities. During his short tenure of two years, Ranbaxy Laboratories announced the first and major partnership deal with a global pharmaceutical major, GSK for drug discovery work. The state-of-the-art facility in Pune, Advinus Drug Discovery, develops its own drug candidates to out-license them at preclinical or clinical stages Dr Barbhaiya says, â€œIt was Kasim and Sanjiv who supported and motivated me to consider taking the risk of becoming an entrepreneur with no platform for backup. A major factor that Dr Barbhaiya admits, in the way for him to turn an entrepreneur is the support by Tata Group as promoters to the venture, Advinus Therapeutics, that came unexpectedly. The decision was made, and there was no looking back. The company got off to a start with the logo designed by Dr Barbhaiya's daughter, Puja, a fashion designer based in the US. Even now, his family is based in the US and he shuttles between New Jersey, and the cities of Bangalore and Pune, where the research facilities of the company are located. Dr Barbhaiya recalls that a phone call from the Tata Group came at a time when he was almost closing the deal with a venture capital firm; and Advinus got a whole new dimension. â€œThe elements of the business plan of Advinus played a crucial role in establishing partnership with Tata Group,â€? says Dr Barbhaiya giving credit to the Tata's support to drug discovery; and investment into the knowledge-based industry, besides the incredible visionary leadership within the Tatas. Stepping untrodden path Advinus with 470 employees, is a company created with a vision â€“ of not entering the field that 15 other companies are into. â€œWe choose to create a drug development center where we can do all regulatory requirements for IND. To put a molecule into human beings, we are the only company with this kind of bandwidth,â€? describes Dr Barbhaiya. Advinus currently has six-seven programs, and aspires for 12-14 in the near future; to enhance drug discovery in a very big way. Dr Barbhaiya adds, â€œAdvinus works on non-validated targetsâ€?. Of the success milestones, Dr Barbhaiya states that Advinus is a company with many firsts â€“ to conduct toxicology studies INDs have been filed in the US and Canada besides other countries; also, a two-year carcinogenous study with a US-based company; it's molecule gk-001 has been worked from discovery to human studies; and is the only molecule for which 100 percent IND work has been done in India. â€œWe are very proud that we have the 100 percent made in India molecule.â€? Among the other notable firsts are that Advinus is the first partner for Merck; it is also the first company to work on R&D in neglected diseases â€“ particularly those significant to India. Inspired by his grandfather's words: â€œI should play a game to win it and try not to lose it.â€? Dr Barbhaiya admits that a major factor for success of Advinus as a company is the senior team. In today's world, it is a big deal for the senior team to remain intact. He shares that many senior employees of Advinus have moved to India not to make a living â€“ having left behind successful careers in the US. They are here to make a difference to India's pharmaceutical R&D. Sharing the vision for Advinus for the next five years, Dr Barbhaiya says, â€œHaving the senior team intact, giving fresh thought to the next phase of growth to go leaps and bounds (for which we may look for a strategic investor from outside); achieve turnover of $40-50 million â€“ not by entering manufacturing, but by building more capabilities.â€? â€œThe dream of Advinus could not have been fulfilled without Dr Kasim Mookhtiar, Sanjiv Kaul; Homi Khusrokhan, managing director, Tata Chemicals; Dr Venkat S Sohoni, managing director, Rallis India; R Gopalakrishnan, executive director, Tata Sons; and Kishor A Chaukar, managing director, Tata Industries,â€? admits Dr Barbhaiya. â€œTheir passionate commitment was crucial in creating Advinus. Their tireless and sustained support made it possible to bring Advinus where it is today,â€? concludes Dr Barbhaiya. First Person â€œRashmi as a person â€“ is large-hearted, warm, caring, emotional, meticulous, organized and a commanding personality. Rashmi as a professional - tremendous self-belief, well respected, passionate about research, face of Advinus, and today's poster boy for innovative pharma research in Indiaâ€? -Sanjiv Kaul, MD, ChrysCapital Investment Advisors â€œDr Barbhaiya is a brilliant blend of science and business; and is wonderful to talk to. His desire to discover new molecules is backed by a thorough scientific knowledge and a passion to prove that one can do this from Indiaâ€? -Anu Acharya, CEO, Ocimum Biosolutions â€œDr Rashmi has brought multinational experience and expertise he developed in the US to India. Through Advinus, he has been effectively translating his learnings, to deliver the India advantage; and culture to meet the global needsâ€? -Kiran Mazumdar-Shaw, CMD, Biocon â€œDuring the five years that I have known Dr Barbhaiya, I had the opportunity to learn from him science, drug discovery business and even HR! He brings with him a unique style of management; comprising professionalism of the West and seamlessly merging it with personalized flavor of Indian style. He has led from the front on many initiatives; and the noteworthy among them is his value for ethics and integrity. In every employee survey, we have seen that our employees have rated highly Advinus' culture of ethics and integrityâ€? -Thomas Putti, VP & Head (Human Resources), Advinus â€œI know Dr Barbhaiya for over 15 years as scientist, colleague, mentor and friend. Our professional lives have been inextricably linked during this period, starting with my joining BMS in 1992; to our current collaboration at Advinus. Rashmi is a dynamic leader. He is one of the gifted people who is charismatic, a person who attracts others by his sheer personality. This charisma allows him to engage and interact with people who are best at what they doâ€? -Dr Kasim Mookthiar, CSO & Executive VP (Drug Discovery), Advinus â€œDr Barbhaiya has a unique, distinctive and effective style of leadership. He is a visionary and creative leader. He communicates opinions, facts, thoughts in a very open transparent and honest manner. He has the unique ability to convey key messages with a â€œone-liner anecdoteâ€? to hone on the bottom line. He speaks out openly on all issues while supporting his team. Above all, he holds the highest standards for ethics and integrityâ€? -Dr Nimish Vachharajani, Senior VP & Head (Pharmaceuticals & Agrochemical Development), Advinus Achievements of Advinus Key successes in drug discovery Discovery of a novel molecule for treatment of type 2 diabetes on a new target in pre-clinical development (in partnership with a large pharma) which is now in phase I clinical trials â€“ A Glucokinase Activator and other initiatives include: ♦ Promising compounds for IBD, asthma/COPD and Parkinson's disease that could be ready for IND enabling studies in current/next fiscal. ♦ A neglected disease initiative to address the unmet medical needs of â€œKala Azarâ€? with DNDi. Key successes in development ♦ A client base of about 80 global pharmaceutical, biotechnology and agrochemical companies. ♦ First company in India to establish services in regulatory toxicology, DMPK and safety pharmacology; and also to develop IND packages for clinical trials initiation in the US, Canada, Germany, France and other countries. ♦ Developed the first internal molecule for clinical studies and enabled the identification of the second candidate â€“ first molecule discovered and fully developed in India is undergoing clinical trials. â€œPursue your dreams, believe in yourselfâ€? Q What is the Advinus mission? To create a name like the IT industry for pharmaceutical R&D in India; win respect and achieve success. We want to make a difference to India's pharmaceutical R&D. We have felt great and happy about the success of our competitors. Q How do you treat your employees? When they fail, I do not crucify them as long as the failure is not because of negligence. We believe in team work. As individuals we are great, but collectively we fall apart. Managing a team by striking a good balance is a sure way to success in any business. Q How do you describe your role at Advinus? I soften targets (potential clients). Then the other team members move in to negotiate the deals. The best way to describe my role is that I am like the air force. After air strikes, the ground level battalion has to move in to win the battle. Q Who can become an entrepreneur? For a person who is capable, success will follow. I never aspired to become a CEO. I did my work and became what I am. Q What words of motivation would you give aspiring entrepreneurs? Pursue your dreams; believe in yourself. Have the right concept and ideas; and most importantly, the ability to articulate your ideas. Then success is sure to come your way. Q How do you see the Indian biotechnology industry in the past 10 years and now? I have profound respect for outstanding work that has been done; the never-say-die spirit of Indians; entrepreneurial abilities that Indians have. Regulatory reforms by the Indian government in this area is an immediate requirement for further growth of the industry. ❖ Narayan Kulkarni in Bangalore ]]> <![CDATA[Master of Innovation]]> https://biospectrumindia.com/news/95/2332/master-of-innovation.html https://biospectrumindia.com/news/95/2332/master-of-innovation.html Thu, 09 Dec 2010 14:38:00 +0530 He made a quiet entry into Indian life sciences industry in 1998, taking over the reins of Glenmark Pharmaceuticals. Today, Glenn Saldanha, MD & CEO of Glenmark Pharmaceuticals has set a benchmark with a robust, burgeoning pipeline of NCEs and NBEs Glenn Saldanha's is a daring story of venturing into the high risk space of novel drug discovery research. This, in a decade when innovation was the most-used buzzword but there were few who took the innovator path in drug discovery - where 10 years of work is just a blink-and-a-half in the product cycle, and failure a norm. Resolutely pursuing this path, Saldanha â€“ in the process â€“ has earned for Indian life sciences industry a place on the global innovation map and a taste for success. This, aside from growing his company manifold. In fact, to over $500 million (2300 crore) in turnover â€“ from just about $18 million (82.8 crore) in 1998, when he took charge as director. Glenmark, under his leadership has expanded rapidly in discovery research of small molecules and biologics, along with branded generics and formulations. His steely determination and conviction has been instrumental. Enroute, he has faced bitter criticism but his detractors are now eating their words with Glenmark securing its position as a respected center for innovative drug discovery â€“ both in small molecules and biologics. The Midas Touch Glenmark Pharmaceuticals started operations in 1977 under Glenn Saldanha's father, Gracias Saldanha. Named after his two sons, Glenn and Mark, Saldanha Senior focused on the manufacturing and marketing of formulations products in India. In just two years, the company crossed breakeven point, recording profits of 26,363.72. Subsequently, the company started exporting to semi-regulated markets, globally. And by 1981, the turnover touched the 1 crore mark. However, it was only after Glenn Saldanha's entry as director in 1998 that Glenmark Pharmaceuticals ascent on the steep growth curve began. Gracias Saldanha retired from the company in the year 2000. Glenn Saldanha came armed with work experience of few years in the US, where he put in time with Eli Lilly and Pricewaterhouse Coopers. His stint with these two well-known MNCs had a pivotal role in shaping his beliefs and outlook towards the business. The exposure in the US also provided him an opportunity to work with global pharma giants, such as Merck, Bristol Myers Squibb and Johnson & Johnson. â€œMy roots come from my early years as an MBA student in New York University; and working with Eli Lilly and Pricewaterhouse Coopers where, I acquired most of my skill set, which gave me a headstart in India. Consulting to the pharma business gave me a good insight into how the business works,â€? says Saldanha. He joined the company with a two-fold strategy in mind. â€œIn 1998, about 99 percent of our business came from India. My game-plan was to globalize our name and generate as much revenue as possible through generics and re-invest some of the money in innovation and intellectual property. The strategy was to bring out our products, outlicense it to the US, Europe and Japan; and retain the rights with us for the rest of the world (RoW), either by exclusive or co-marketing rights and build infrastructure in RoW markets. So that when the molecule comes to market â€“ we would already have an infrastructure in place,â€? he reveals. The company has been growing from strength-to-strength. For FY 2009-2010, Glenmark clocked an annual turnover of over 2500 crore, which was a growth of 18 percent over the previous fiscal. In the current fiscal it will easily cross 3000 crore. It has operations in 80 countries, with employee strength of nearly 7,000 people, globally. Glenmark today has five research facilities, 13 manufacturing facilities in four countries and seven new molecules in clinics. The company's New Chemical Entity (NCE), Crofelemer, a first-in-class anti-diarrhoeal drug, has successfully completed phase III trials for HIV-related diarrhoea. Glenmark has exclusive marketing and distribution rights for this compound for multiple indications across 140 countries. Saldanha anticipates approval of Crofelemer in India in 2012. In the biologics space, Glenmark's lead products GBR 500 and GBR 600 have entered clinics. Saldanha is known for his acumen in signing significant licensing deals with some of the big MNCs. In 2010, the company entered into two landmark deals. Its subsidiary in Switzerland granted a license to Sanofi-aventis for developing vanilloid receptor and GRC 15300. The latter is currently in phase I clinical development for treating diabetic neuropathic pain and osteoarthritic pain. The subsidiary has also been granted a worldwide license by Italian-based company, Lay Line Genomics (LLG) to its entire IP portfolio in the TrkA field, which includes monoclonal antibody BXL1H5. This represents another first-in-class opportunity for Glenmark. â€œResearchers at Glenmark focus on developing monoclonal antibodies. Glenmark is the first Indian company that has a novel, first-in-class novel biologic entity in the clinics in the US. We are establishing platform technologies to develop biologics in a format specific for Glenmarkâ€? -Dr Michael Buschle, president (biologics), Glenmark Pharmaceuticals First Person â€œGlenn Saldanha is one of the pioneers in making India's R&D story a success. He has been a forerunner in making major licensing deals possible. He has been careful in selection of his pipeline molecules by taking all the stakes into considerationâ€? -Sujay Shetty, associate director (pharma & life sciences), Pricewaterhouse Coopers, India â€œGlenmark's focus on pharmaceutical generics business and drug discovery research to fulfill the unmet needs of patients impresses me. It takes a lot of guts for any leader to restructure an existing successful business to create an expensive and high risk cost center to invest in R&Dâ€? -Tapan Ray, director general, OPPI â€œGlenn Saldanha's vision of an innovation-led organization and his drive and passion to achieve that vision has been a key differentiating aspect for Glenmark. Today, the fact that Glenmark has several molecules in clinical development for unmet medical needs is a significant achievement for an Indian organizationâ€? -AS Mohanty, executive director, Glenmark Pharmaceuticals Forerunner in Drug Discovery In 2000, while other companies were looking to capture a sizable share in the generics space, Saldanha saw that to achieve a healthy growth curve in future, Glenmark needed a paradigm shift towards the high-risk space of novel drug discovery research. This was around the time when India was a signatory to the GATT and was moving towards the product patent regime. â€œWhat makes Glenmark unique is that we have been extremely passionate about innovation, since the beginning of this decade. There was a great opportunity for India to move into this space because of the low cost of R&D; and we used that opportunity to the maximum advantage,â€? he recollects. Glenmark took the IPO route, getting listed in 2000. The company got oversubscribed 65 times and its market capitalization touched $40 million. It then invested the proceeds in setting up an R&D center in Mumbai to carry out innovative drug discovery research - marking its first step into NCE discovery This R&D centre is spread over 1,25,000 sq ft with over 200 scientists working on multiple targets in broad therapeutic areas, and have been responsible for discovering 13 NCEs in a short span of nine years. The company thus pursued its innovation research with small molecules from 2000-2004. While domestic companies were on the run to hive out their R&D units, Saldanha opted to restructure his business into two clear divisions â€“ specialty and generics. â€œThere are lots of synergies between R&D and the branded generics side of the business. Our mix is very clear â€“ we have Glenmark Generics, which focuses on branded generics and Glenmark Pharma, which is our innovation engine. The reason for not hiving out the business is that there were times when our R&D division supported the generics side of the business and vice-versa,â€? he explains. During 2005-2006, Saldanha realized that the innovation sphere was changing - and the move was towards antibodies and biologics. â€œWe saw that the company needed certain skill sets in biologicals. This prompted us to venture into it,â€? he says. The company then set up a facility in Switzerland, Glenmark Pharmaceuticals SA, dedicated to biologics research. Why Switzerland? â€œTo counter the skill set gap in India, we looked overseas and assessed that Switzerland was a high benefit proposition. Also, there is cutting edge research happening in the space of monoclonal antibodies in Europe and a lot of talent is available,â€? he elaborates. The current team comprises around 50 scientists, with expertise in molecular biology, cell biology, immunology, antibody engineering, quality control and quality assurance, process development and biologics product development. Dr. Michael Buschle, who brings with him 25 years of experience in biologics, heads the operations in the capacity of president. Operational since 2006, Glenmark Pharmaceuticals SA has filed several patents on novel monoclonal antibodies. Lead product GBR 500, an NBE under development for treatment of multiple sclerosis (MS) and other inflammatory diseases, is undergoing phase I clinical trials in the US and GBR 600 a monoclonal anti-platelet antibody, is ready to start phase I trials in the UK. The market opportunities for both these NBEs are huge. In the MS segment, GBR 500 has a market opportunity of up to $3 billion while GBR 600 has a market opportunity of $2 billion. â€œWe have a whole pipeline of MAbs, and every year you will see one or two MAbs going into clinical trials. This is all novel antibody work and we have our own patents and IP,â€? he elaborates. Biologics research at Glenmark Pharmaceuticals SA will look at targeting areas like oncology, immunology along with RA and various inflammatory conditions. The unit has capabilities to develop monoclonal antibodies from inception to preclinical; and undertake the necessary development work for clinical studies. Saldanha believes that biosimilars is a big opportunity for Indian biotech companies and while he may consider entering this space in the future - he is convinced that novel biologics is the way ahead. The Challenges Saldanha's bold step into drug discovery space came with a host of challenges. However, he stuck to his guns. â€œBack in 2000-2004 we got a lot of flak from shareholders for investing in innovative research, because they believed that a small company like Glenmark could not deliver on innovation,â€? recalls Saldanha. It was a host of licensing deals that bolstered investor confidence. In 2004, the company signed its first licensing deal with Forest Labs for PDE4 Inhibitor, then in 2006, an outlicensing deal with Merck and in 2007, it out-licensed GRC 6211 to Eli Lilly. â€œThat gave people a stronger belief that we know how to play the game and how innovation can be done despite limited resources. By 2007, we were the darlings of the investors,â€? he adds. By then, the company's market cap touched $4 billion (18,339 crore). In 2008, Glenmark faced major reversals. GRC 6211 was returned by Eli Lilly, Merck terminated its dealfor GRC 8200, the Forest deal also failed. This impacted the company's stock price and its valuation adversely. â€œThe years 2008-2009 were dry years for us, people lost confidence in Glenmark. But luckily, we had cash in hand, having spent only half of about $125 million (550 crore) set aside for innovation. Recession in the global economy added to our challenges,â€? he reveals. By 2010, the company bounced back strongly. The deals with Sanofi aventis and Lay Line Genomics, bolstered the investor morale; and Saldanha hopes to see more such deals. â€œWe have seen the whole cycle â€“ right from being nobody, with people doubting our capabilities to being the darlings, and then plummeting down, and then starting all over again,â€? he quips Despite predicaments, the company's conviction and passion never wavered. â€œNothing has changed over the past 10 years. We still have the same drive and motivation to innovate. We did not doubt the way we built up the business, even in the dry period,â€? Saldanha asserts. Nayantara Som in Mumbai ]]> <![CDATA[Karnataka: State of excellent life sciences ecosystem]]> https://biospectrumindia.com/news/95/3803/karnataka-state-of-excellent-life-sciences-ecosystem.html https://biospectrumindia.com/news/95/3803/karnataka-state-of-excellent-life-sciences-ecosystem.html Thu, 09 Dec 2010 14:33:00 +0530 Karnataka is the major biotechnology hotspot in India - and Bangalore, the capital, is globally known as the country's premier IT and BT nerve center. BioSpectrum honors Karnataka with the State of the Year Award 2010, for its life sciences-friendly ecosystem Nandan Biomatrix, a sustainable energy company with headquarters in Hyderabad, is setting up a biotechnology park in Bidar, a remote area in northern Karnataka, at an investment of 96 crore. Hindustan Petroleum Corporation Limited (HPCL), Indian refining and marketing major, is setting up a huge green R&D center in Bangalore at an investment of 550 crore; and Kemwell, a leading provider of contract manufacturing and development services, is expanding operations in Bangalore, at an investment of 257 crore. These announcements show that Karnataka has an edge over other States, in attracting investments. This is largely due to the State government's initiatives with the announcement of Millennium Biotech Policy II, support of the industry-academia group (Vision Group on Biotechnology - led by Kiran Mazumdar Shaw of Biocon) to drive the growth of the industry. Karnataka has emerged an ideal location for both multinationals and new entrepreneurs, to set up biotechnology (BT) business in India. Of 350 biotechnology companies in India, 170 companies are based in Karnataka; and generate revenues of up to 3,000 crore. The Government of Karnataka is committed to establishing a biotechnology corridor for the development of biotechnology industry in the State. Government initiatives Karnataka was the first Indian State to announce the Biotech Policy in 2001. With changing times and business environment, the State government realized the need to come up with a new policy to support the biotechnology industry. On December 9, 2009, Karnataka unveiled its Millennium Biotech Policy II. The new policy outlines steps to further enhance the development of the biotechnology industry, and harness its benefits for the common citizen, in the years to come. The policy offers a number of additional fiscal incentives and concessions. Apart from rebate on stamp duty and exemption of entry tax, electricity duty and industrial power tariff; there are additional incentives like investment promotion subsidy, waiver of conversion fine, subsidy for effluent treatment plants (ETPs), interest free loan on VAT, anchor unit subsidy, interest subsidy, financial support towards patent registration, standardization, water conservation and energy conservation. As a focus area, the policy makes special commitments in the area of biofuels. Karnataka has joined the international movement to go green. The State has set a goal to meet 20 percent of its fuel needs from biofuels by 2020. Karnataka is setting up a bio-venture fund, with a corpus of 50 crore, in partnership with professional venture capital firms. The State will give 26 percent of the fund; and the remaining 74 percent will be raised from venture capitalists. It has also set up a corpus fund of 20 crore to facilitate grant of 20 lakh each, for enabling commercialization of research results. Besides the State government's support, the industry has the advantage of the presence of a strong investor community/venture capitalists like i2India Ventures, Canbank Venture Capital, KITVEN Fund in the State. The State government, together with Government of India, has proposed to set up a Bio IT park in Bangalore's Institute of Bioinformatics and Applied Biotechnology (IBAB) campus, on a public-private partnership model. The Bio IT facility will be a hub for both IT and life sciences organizations, research institutions and academia. Apart from BioIT facility, the Karnataka government has taken initiatives to set up biotechnology parks across the State, to encourage the sector's growth. Major projects include, Bangalore Helix, a 106-acre state-of-the-art biotechnology park in Bangalore; Vivarium, an animal house in Bidar; Nutri/Nutraceutical and Phyto/Pharmaceutical Park (N2P2), an institute under the Central Food Technological Research Institute (CFTRI), in Mysore; a Marine Biotech Park in Mangalore; and an Agri-Biotech Park in Dharwad. The parks are scheduled to become operational by 2011. The government is also promoting the establishment of biotechnology parks by the private sector. Plugging the gaps In a step towards improving the quality of human resources for the biotechnology sector, and bridging the gap between industry and academia, the State government has promoted a new concept called Finishing Schools, with the support of Association of Biotechnology led Enterprises (ABLE), the lobby group for the biotechnology industry; and Vision Group on Biotechnology, with government's financial support of 1 crore per Finishing School. Karnataka has a Centre for Cellular and Molecular Platforms (C-CAMP), under the Department of Biotechnology, Government of India; which will act as an enabler of success in bioscience research and entrepreneurship by providing research, development, training and services in state-of-the-art technology platforms. C-CAMP, together with National Centre for Biological Sciences (NCBS) and Institute for Stem Cell Biology & Regenerative Medicine (inStem) form the Bangalore Bio-Cluster. These three entities bring together unique individual capabilities and a shared multi-disciplinary approach; to create an interactive bioscience and technology research enterprise. Finally, Karnataka's flagship biotechnology event, Bangalore India Bio, has been a major tool in providing and enhancing partnering opportunities for Indian biotechnology companies, with global companies for the past 10 years. With such significant success, Karnataka has been driving on its strengths and advantages; and should continue to look at supporting the growth of the industry, by implementing policy initiatives and proper monitoring of the schemes. Otherwise, the companies with global aspirations such as Biocon, will look at other destinations like Malaysia for their growth.â€œKarnataka is already a leader in the life sciences sector. First time entrepreneurs are more in Karnataka; innovation and value addition are happening at all levelsâ€? -Ashok Kumar C Manoli, Principal Secretary to Govt, Department of IT, BT and S&T, Government of Karnataka What makes Bangalore attractive? â€œBangalore is a part of the largest biotechnology cluster in the country that has industry-friendly State government policies; and a good supply of talent poolâ€? -KK Narayanan, MD, Metahelix Life Sciences â€œAfter being considered the Silicon Valley of India, Bangalore, is also emerging as a biotechnology hub; and it provides good opportunity for life sciences companiesâ€? -GS Krishnan, regional president (India), Novozymes â€œBangalore has always been widely regarded as the knowledge hub of India, hence businesses that need specialized knowledge-based skills have always found Bangalore a very attractive destinationâ€? -Anurag Gupta, country manager, GE Healthcare Life Sciences, India â€œBangalore is fast emerging as an undisputed investment destination for the life sciences and biotechnology companies. With over 180 biotechnology companies located in Bangalore, it alone accounts for one-fifth of the country's biotechnology revenueâ€? -CS Jadhav, director (marketing), Nandan Biomatrix â€œBangalore has excellent scientific and medical infrastructure. It has attracted research headquarters of global companies. Bangalore has developed an excellent life sciences ecosystem -DA Prasanna, founder & chairman, Ecron Acunova â€œThe Government of India is setting up an Institute for Stem Cell Science and Regenerative in Bangalore at an investment of 203 crore. This infrastructure set up makes Bangalore the best location for the niche regenerative medicine fieldâ€? -BN Manohar, president, Stempeutics Research â€œKarnataka has an edge over other Statesâ€? Q What are the unique strategies adopted by Karnataka to promote life sciences companies? Through policy and fund initiatives, the Karnataka government encourages growth of the life sciences sector in the State. We are planning to set up a new Center for Human Genetics (CHG) with Prof Sharat Chandra as director, at the BioIT facility. The Karnataka government has decided to grant an additional 3 crore corpus fund for CHG, to encourage its activities in the field of DNA analysis. We want CHG to work in unison with Institute of Bioinformatics & Applied Biotechnology (IBAB). IBAB's Center for Genome Sequencing will also be an added attraction of the BioIT park. Karnataka is promoting the establishment of biotechnology parks throughout the State. We are in the process of finalizing Nutri/Nutraceutical and Phyto/Pharmaceutical Park, and we expect to get the approval from the central government within two months. If that happens, N2P2 will be the first-of its kind project in the country. We are in the final stages of discussion with Government of Spain and an American University, to set up the Agri-Biotech Park. Q How are the policy and infrastructure initiatives of the Millenium Biotech Policy II progressing? We have provided several incentives for the biotechnology industry as part of the Millennium Biotech Policy II. According to the policy, we will provide 20 percent of the capital infrastructure. Besides two biotechnology schools were selected for the Biotech Finishing Schools project; and 10 more schools are shortlisted. The committee for setting up Finishing Schools is headed by Prof G Padmanabhan, emeritus professor at IISC, Bangalore; and it is conceptualized by the Vision Group headed by Kiran Mazumdar-Shaw of Biocon. The Finishing School will become operational from the next academic year. We will direct funds through the bio-venture fund initiative maintained by KITVEN fund - which was meant only for IT - and has now been extended to biotechnology as well. We are encouraging new ventures by providing fund assistance. The funds are allotted as grant, and partly as soft loan, at three-to-four percent interest. Q What makes Karnataka a promising base for the life sciences industry? Karnataka is already a leader in the life sciences sector. First time entrepreneurs are more in Karnataka; innovation and value addition are happening at all levels. Interest shown by companies to set up biotechnology parks in rural areas like Bidar, show the confidence of biotechnology companies to set their base in the State. Major credit for this progress goes to the Vision Group headed by Kiran Mazumdar-Shaw, members and subject experts of the team. We send senior officers to various countries to promote our State in this sector. The State government is very keen on developing biotechnology. Pradeep Kumar & Narayan Kulkarni in Bangalore ]]> <![CDATA[Change Agent]]> https://biospectrumindia.com/news/95/2109/change-agent.html https://biospectrumindia.com/news/95/2109/change-agent.html Thu, 09 Dec 2010 14:29:00 +0530 Deep engagement with her environment is zen for her. The city she lives in, industry for which she is the forerunner, company she has built and then reinvented â€“ she is hands-on everywhere. Dr Kiran Mazumdar-Shaw, CMD of Biocon, is raring to go some more distance to be the change she wants to see Challenges are not new to her. Dr Kiran Mazumdar-Shaw's journey from 1978 to 2010 has been ridden with them. Right from trying to find a job for herself to setting up Biocon, to taking it where it is today - half-a-billion dollar in revenues with 4,500 employees, and a future ready business model - none of this has been a cakewalk. And Biocon is back at the top of the BioSpectrum-ABLE ranking as the No.1 company after conceding that slot to Pune's Serum Institute for the last four years. Strategic transformation In the last 10 years, she led the transformation of Biocon from an enzyme maker to a biopharmaceutical company â€“ from the front. â€œThe strategy to pursue this transformation path has been that of a clear-cut differentiation at every level. We have been very committed to our strategy from the very beginning,â€? says Dr Mazumdar-Shaw. For Biocon, this strategy translated into technology becoming the first differentiator. Then followed the development of technology platform to build this business, which at a broad level was fermentation. The company chose microbial fermentation, pichia fermentation and cell culture as platform differentiators. â€œWhen one follows a technology-driven strategy, it is important to identify and plug the gaps. When we realized that biomanufacturing is going to be an all-pervasive strategy for us, we decided to add mammalian cell culture. And that's where partnership with Cuba's Center for Molecular Immunology came in,â€? she says. Next on line was the product strategy. Biocon went though painstaking details again to zero down on the products to build and develop â€“ from API to statins to finished products to the disease area â€“ leading it to diabetes, which today still is the single largest unmet medical need in India. â€œWe went on to combine our insulin strategy with the pichia fermentation platform,â€? she adds. The Cuban opportunity also allowed Biocon to focus on the autoimmune diseases. For Dr Mazumdar-Shaw, all these developments came together to formulate into an important mission â€“ the mission of delivering affordable innovation. And that essentially sums up what Biocon is onto, and is a driving factor in every decision that is taken in the company. However, the mother of all challenges that a company faces, has just arrived for her: The proverbial â€œnext levelâ€? â€“ challenge of scale. With a vision of putting a Biocon product in every market, globally, she has already moved to tackle it. The recent Pfizer-Biocon deal is a step in this direction. So is the $160 million investment to set up manufacturing and research facilities in Malaysia. Though the minutiae of the challenge is a tough-one for any business. Integrating the islands of excellence â€“ that demonstrate efficiency, competence, reliability â€“ into a system that allows scale-up, and consequently gives the competitive edge in the global multi-location market place, is something she believes will be easier to execute along with a partner like Pfizer, which has world class systems in place. So, while the deal is a marketing deal, the learnings from Pfizer will have a far-reaching positive impact on Biocon. Change is her inspiration She is an inspirational figure for millions of young Indians who want to emulate her as one of the most well known entrepreneurs of the country. But who inspires her? â€œI am inspired by a large number of people... I get inspired by people who have brought about change despite obstacles, and have done amazing things â€“ irrespective of how big and small these are. N R Narayana Murthy (Infosys), who has created the burgeoning Indian software industry, Dr Devi Shetty (Narayana Hrudayalaya), who has created the affordable hospital model, Dr Bala Manian (ReaMetrix), well into sixties, came back from the US to set up a very innovative company in India, Dr P Babu who helped me build Biocon, Dr R A Mashelkar (former DG of CSIR) who has been instrumental in creating the patent regime in India... every one around me has been an inspiration in some way or the other. I take inspiration from all quarters. In terms of personality type â€“ daring risk-takers who bring about a change inspire me most,â€? Dr Mazumdar-Shaw says candidly. Challenges on the horizon Biocon has arrived at a stage where it is counted among the Top 20 pure biotech companies in the world, in terms of size, product portfolio and employees. What Next? Mazumdar-Shaw is the first one to acknowledge that the challenges are many. â€œEach phase brings in a new set of challenges. Getting to understand innovation and drug development is a challenge. I will have to learn a lot about the risk associated with the global drug development, â€œshe points. â€œAnd then take some of Biocon's products global. Managing the scaling-up is a challenge. Keeping the momentum going is itself a challenge. Attracting good people and keeping them as engaged and passionate as I am, is a challenge.â€? Even as Biocon prepares to face these challenges, there is enormous pressure on her time, due to the visibility that has come with the titles of â€œ Poster Girl of Indian Biotechâ€? or â€œIndia's Richest Womanâ€? or â€œOne of the most prominent face of Bangalore and Indiaâ€?. How much time does she get to devote to Biocon now? â€œMy time spent outside is not that much. But because of media coverage it looks out of proportion,â€? she says. â€œI am involved with a number of institutions outside, but modern communication tools help me do most of what is required from Bangalore itself.â€? â€œIn my earlier years, it was very important to build the biotech image for the country. So, I used to spend a lot of time in attending conferences, leading delegations. I have led many delegations to the US, UK, Australia, Germany, France... now I have to become selective, as I cannot factor it all in my schedule. However, I continue to be very engaged with my city - Bangalore and some other national-level interests of the industry. â€œI am on the Prime Minister's Council, India-US CEO Forum, Board of Trade, Ministry of Commerce & Industry and Innovation Council... I am able to contribute my bit via these forums... as most of work can be done offline with just a couple of meetings a year.â€? â€œOf course, I continue to remain involved with ABLE (the Association of Biotechnology-Led Enterprises which she founded in 2001) because I believe biotech has not come of age in India. There cannot be just one Biocon as the public face of Indian biotech. We need at least 12-15 biotech companies going public, to be able to say that the sector has arrived. Till then, I have speak for the industry,â€? Mazumdar-Shaw justifies her time well spent outside the company. â€œWe are getting carried away by the growth story of India Inc., and gloating over it, without backing it up with the infrastructure that is required for that kind of growth,â€? she says. Unless the country gets its act together and does something about infrastructure, having an industry-ready talent pool and stemming corruption; we will not be able to realize the full potential of the opportunity,â€? she advises. Ten years ago, when Biocon rebranded itself as a biotechnology company, there were many skeptics. Now, 10 years later, there is grudging admiration for the tenacity displayed by Biocon under her leadership. For, despite ups and down, Biocon stuck to the vision outlined by her; delivered a number of products in diabetes and oncology sector, became a leader in the chosen field, built up an integrated platform with manufacturing, research and services. And of course, setting the stage for other companies to follow with a blockbuster IPO in 2005. What has happened in the last decade is just the beginning. The best days of Biocon will come in the next decade, when its insulin products and a few more, will be available in markets around the world, thanks to the tie-up with Pfizer.â€œManage the eco system, not the ego systemâ€? Q Given that you are a hands-on leader, how do you balance this with your core team? Each one in my team shares my vision â€“ all the things that I passionately believe in. I delegate extensively. I want people to take ownership of their roles and responsibilities. I do not micro manage or even macro manage. My main strength is strategy and I focus on it. I focus on showing the way, setting the direction and paving the way. I just drive the vision. Every one of my key people is a strategic person. They deliver on what I state and more on those lines. For the delivery side, I delegate to the experts I have on the team. Q Beyond your core team, how do you get the thousands of employees at Biocon share your vision? I have always inculcated a very high level of ownership in the organization. That sentiment has percolated down the line, and by osmosis is absorbed in the company. I am proud of the fact that we do not penalize failures and encourage entrepreneurial risk-taking in the organization. People who work here are not shy or fearful of risk taking. This is a company that tolerates mistakes and failures. And it is because of this culture that is osmotically imbibed in the company, that we have taken on daring projects and embarked on business plans â€“ which have been daring by any standards. Essentially, what I say in 'normal speak' is: manage the ecosystem not the ego system. The essence percolates down on its own. Q What is it about a business leader that set him/ her apart? The DNA that sets business leaders apart is: They need to be very clear and articulate about the mission; they should be perceived as bold and global in their vision; and above all, have a bearing of influence that essentially comes from a sense of their achievements. In today's context, leadership is looking beyond your company and articulating your sector's and country's interest. â€œCharting the road mapâ€? Q Is Biocon the brand that you are focusing on, or are there individual products being positioned as brands? In the market, there are strong standalone brands â€“ that make companies. It is important to have a product brand focus. We hope that from our product portfolio, some of the products like Insugen, BioMAb will emerge as brands. If you look at the Biocon strategy, each one of the segments that the company is in, is anchored around a brand. For example: diabetes has Insugen as the anchor brand, oncology has BioMAb as the anchor brand and, nephrology has Erypro. These brands will speak for themselves when each of them become a 100 crore brand, however, in the formative years, a brand leverage is required â€“ which is brand Biocon. In that respect, the company's positioning as a reliable brand is just as important in fact, more so. So, Insugen can become the first 100 crore brand in India; and that will be our first milestone. Next level, of course, will involve taking it to the multi-crore level. Q How did this marketing deal with Pfizer impact the company? It is interesting when you engage with a large company. On one level, it is a giant, at another, it is about people. On the face of it, a large pharma would be a daunting partner, but when we actually got down to engaging with key people we found a lot of good vibes and good chemistry on both sides. In the initial years of Biocon, we have worked in partnership with Unilever and that was also a fantastic partnership. It was a similar situation. At the company level, we were pygmy and they a giant. However, at the people level there was a great degree of mutual respect. The fact that we were able to scale up from a small entrepreneur-driven firm to a professionally- run company, is due to the learning we had from having Unilever as a partner for 10 years. With Pfizer as a partner, it will again be a steep learning curve for Biocon. Pfizer brings in huge systems that we can benefit from, and deepen our knowledge base across functions ranging from marketing, supply chain to regulatory. Essentially, it brings about a certain discipline with which we go about our activities in all areas â€“ be it financial reporting, GMP, R&D or regulation. It is an opportunity for us to learn and move to the next level. In fact, this learning about systems is a key aspect in managing the challenge of scale. Q Now, Biocon itself has graduated to the level of a foreign investor. What is this strategy about? Malaysia was a decision we took as a de-risking strategy. Basically, we looked at what is happening in India. Unfortunately, infrastructure in India is sub-optimal. Government in India has done very little apart from spelling out the enabling policies. They have not supported high technology industry like ours, with a high-end reliable infrastructure. Today, I cannot afford to invest $200 million in Vishakapatnam where there is no surety of reliable power supply, water and effluent treatment. If I were to put in capital for all this, then the capital cost would be much higher. Compared to this is Malaysia, which has turned out to be such an attractive proposition â€“ better tax incentive, much better infrastructure, guaranteed power, water and effluent treatment support, training and R&D incentives â€“ in a comprehensive package. When I evaluated how much it will cost, to run an operation like this at Johor in Malaysia versus Vishakapatnam, I saw that, in the long term, we were better off in Johor. In Malaysia, biotech is a thrust area and the government is going great length to get the sector up and running for the stakeholders. I recollect, that about five years back, I had given my inputs for the biotech policy in Malaysia. And I see today, that all of these have been made actionable. They have even waived-off 'Bhumiputra clause' and have instead factored in R&D grants and incentives for training local people. Training is expensive and they are willing to support the industry. It has turned out to be a comprehensive attractive proposition. I have taken this investment out of India to Malaysia only because I am not happy with the industrial support that is available in the country at this point in time. Nandita Singh & Narayanan Suresh in Bangalore ]]> <![CDATA[Cryogel simplifies cell separation]]> https://biospectrumindia.com/news/95/1306/cryogel-simplifies-cell-separation.html https://biospectrumindia.com/news/95/1306/cryogel-simplifies-cell-separation.html Thu, 09 Dec 2010 13:14:00 +0530 The unique ‘Cryogel’ matrix, invented by Dr Ashok Kumar and his team at IIT Kanpur, offers new possibilities using affinity cell separation for bioengineering applications. A follow-up report on the inital research reported in BioSpectrum, May 2005 issue Separation or isolation of highly purified therapeutic mammalian cells such as stem cells, leukocytes at preparative scale, holds great importance in medical therapy and diagnostic applications. The bottleneck of currently available methods is their low yields, purity and viability of isolated cell population, and application at the analytical scale. However, now an interesting and unique alternative, in the form of ‘Cryogel’ has come up in cell separation techniques. Cryogel is a polymeric gel formed in moderately frozen media, having a continuous system of interconnected macropores. This new macroporous ‘Cryogel’ matrix for bioengineering applications was developed by Dr Ashok Kumar, associate professor of bioengineering, Department of Biological Sciences and Bioengineering, IIT Kanpur, along with his team. Due to large interconnected pores, mechanically elastic properties and easy production, its application in cell separation has been enhanced, this was previously reported in BioSpectrum (May 2005 issue). The initial research in this area started in 2001; and in subsequent years, resulted in the outcome of ‘Cryogel’. However, it was yet to be established whether it can be used effieciently to separate all forms of cells in a real system. The project was supported by Department of Biotechnology (DBT) and Department of Science and Technology (DST), where  the Cryogel was further used for more complex and a wide variety of cells. The work was further carried out to demonstrate the potential of affinity cryogel matrix for the separation of stem cells (CD34+), directly from umbilical cord blood and fractionation of B and T lymphocytes from peripheral blood. The DBT funded the project with 1 crore and the DST funding was  around 30 lakh. This work of Dr Ashok Kumar and Dr Akshay Srivastava has been recently published in Nature Protocols. Cryogel affinity matrix has been introduced as a new method for affinity cell separation. Dr Ashok Kumar who received his PhD in biotechnology in 1994, jointly from Institute of Genomics and Integrative biology (IGIB), New Delhi and Indian Institute of Technology (IIT), Roorkee, has been working in this area, for more than a decade. After finishing his post-doctoral research at Nagoya University, Japan and Lund University, Sweden, he also worked as faculty of biotechnology in Lund University, Sweden and a group leader in a biotechnology company in Sweden. Dr Kumar is also on the executive board of biomaterials and tissue engineering research and teaching in India; and serves as a task force committee member of DBT. At the international level, besides conducting active international research collaborations with the UK, the US, Japan and Sweden, he is the co-coordinator for Indo-US center for Biomaterials supported by India-US Science and Technology Forum. He is incharge of the India-UK, DST-UKIERI award project and the India-UK science bridge project. Unique Methodology Dr Kumar, whose research areas have been in advanced biomaterials, stem cells, regenerative medicine, tissue engineering, bioprocess engineering and environmental biotechnology, has created a unique methodology to seperate the cells. Commenting on the methodology used, Dr Kumar says, “Monolithic polyacrylamide and polydimethylacrylamide cryogel matrices were prepared using cryogelation technology. The supermacroporous monolithic cryogel has large interconnected pores (up to 100 μm) that help in convective migration of mammalian cells. These cryogel matrices are further functionalized to immobilize a protein A ligand, by a simple and elegant chemistry. Stem cells or lymphocytes were labelled with specific antibodies; and then separated from other cell populations, while passing through cryogel affinity matrix. These cells were isolated with high cell recovery yield, while retaining their viability.” The spongy and elastic character of cryogel matrix has provided a generic way for cell release from cryogel affinity matrix, by compressing the cryogel upto 50 percent of its original length and release of capillary liquid; called mechanical squeezing. The overall cell separation process takes less than 30 minutes for complete separation of cells on affinity cryogel matrices. The 100ml to 200ml of blood can be passed through the column using the cryogel matrix, which is not possible in case of other available columns for cell separation. Besides being actively involved in research focused on cell separation technology and leukocyte filtration devices, Dr Kumar has done some innovative work in regenerative medicine and environmental biotechnology. The major research achievements of Dr Kumar in regenerative medicine include designing of neo-cartilage and bioartificial lever support bioreactor, using cryogel matrices that are at the preclinical stages. In the area of environmental biotechnology, Dr Kumar has suitably designed membrane filtration devices for air and water purification, like arsenic and microbial removal from drinking water and tar removal from cigarette smoke. Technology Advantage Cell separation using cryogel has many advantages over existing cell sorting techniques. Cryogel-based cell chromatography process could be an ideal separation system which can maintain sterility during the whole process. Overall separation strategy is generic, and the same cryogel column can be used for separation of multiple cell-types, up to four-to-five  columns of regeneration. It is easy to execute chromatography using cryogel at any place, such as inside sterile laminar flow, besides in normal laboratory conditions. And the set-up can be moved from one place to another, without much trouble. The cytometry machine which costs about 2 crore is not available to every reseracher easily. Therefore, Cryogel offers access to efficient cell separation at a low cost. “By using cryogel, the target cells could be separated at a preparative scale for medical application. Large volumes of the sample can be processed at once, through affinity cryogel matrix which saves overall separation time” —Dr Ashok Kumar, associate professor of bioengineering, Department of Biological Sciences and Bioengineering, IIT Kanpur Dr Kumar who was part of the Center for Bioseparation in Sweden during 2001-2004 observes, “By using cryogel, the target cells could be separated at a preparative scale for medical application. Large volumes of the sample can be processed at once, through affinity cryogel matrix, which saves overall separation time, in comparison to other methods.” On cost effectiveness of the technique he says, “Target cells bind to affinity cryogel matrix, then these target cells are recovered in the generic way of elution called mechanical squeezing, that saves time and the process becomes cost-effective. Hence, cryogel-based cell affinity chromatography provides a generic way of cell separation.” Besides being a researcher, Dr Kumar has published over 100 peer reviewed research papers in international journals, and  has written more than 10 book chapters; and has several patents in his area of research. He is the editor of three books on cell separations and biomaterials. He is the associate editor of Nanoscale Research Letters; and is on the editorial board of several other biological and biotechnological journals. He is the executive board member of the Federation of Asian Biotechnology. Industry Benefits The cryogel support as a chromatography matrix could have a huge impact on research and development at laboratory as well as industrial scale. The developed method using cryogel is easy and cost-effective. It also eliminates steps of pre-purification of sample during separation. The target cell could be separated in a single step, with sufficiently high purity and yield, which is quite useful for the preparation of target cells in large concentrations; and yields for its application in cell therapy, tissue engineering, cell-based studies. This first time approach of using no buffer or effulent, and reusage of matrix, can cost approxmately about 500, which is far cheaper than any other alternatives. Dr Kumar is optimistic about the transfer of this technogy to industry; and expects to be approached by companies very soon. In fact, he has been in talks with some companies for the same. On commercialization of the technology, Dr Kumar says that, “The technology is ready-to-use, and further contacts with industries are being established that will help to take this stem cell separation technology to commercialization.” The transfer of this home-grown technology to industry will surely bring down the cost of cell separation, besides making it easier for researchers to avail benefits that come with it. Rahul Koul in New Delhi ]]> <![CDATA[Indian biotechs line up for Malaysia]]> https://biospectrumindia.com/news/95/3148/indian-biotechs-line-up-for-malaysia.html https://biospectrumindia.com/news/95/3148/indian-biotechs-line-up-for-malaysia.html Thu, 04 Nov 2010 15:42:00 +0530 Even as India is emerging a hot destination in Asia for doing contact research and manufacturing, clinical research, and discovery services, Indian companies are heading to Malaysia in large numbers. They are going to be Asian neighbors for biomanufacturing, drug discovery, stem cell R&D, molecular diagnostics, aquaculture companies like Biocon, Dr Reddy's Labs, Avesthagen, Actis Biologics - are looking at expanding their operations to Malaysia, lured by its attractive offers and advantages of setting up a base there. Bangalore-based Biocon, India's leading biotechnology company, on October 27, 2010, announced Strategic Foreign Direct Investment of $160 million in Malaysia with the Malaysian biotechnology corporation, BiotechCorp. The investment will be made towards establishing a biomanufacturing and R&D facility in Bio-XCell, a custom-built biotech park and ecosystem in Iskandar Malaysia. In October 2010, India's premier biotechnology company Biocon announced a strategic foreign direct investment (SFDI) of $160 million in Malaysia with the Malaysian Biotechnology Corporation (BiotechCorp). The investment is for setting up a biomanufacturing and R&D facility in Bio-XCell, a custom-built biotechnology park and ecosystem in Iskandar, Malaysia. â€œBiocon's strategic investment in Malaysia will propel our industry to the next level. It will be a catalyst in our commercialisation efforts, as we enter phase 2 of our National Biotechnology Policy â€“ the Science to Business Phase,â€? said Dato' Iskandar Mizal Mahmood, chairman, Malaysian Bio-XCell& CEO, BiotechCorp. â€œThis will be the first high-end biosimilar and biopharmaceutical manufacturing and R&D facility in Malaysia. In compliance with US FDA cGMP standards, it will raise the bar for quality and excellence in the sector and market. Biocon will stimulate growth for the sector and provide commercial opportunities for Malaysian biotechnology's SMEs. We can expect an increased presence of Biocon-affiliated global giants, growing the sector to new heights,â€? Dato' Iskandar said. In this backdrop, customized incentives for large investments, access to ASEAN markets through Free Trade Agreements, no restrictions on equity, adoption to ICH & FDA guidelines for manufacturing activities, industry-friendly regulations, and many other factors are drawing Indian companies to invest in Malaysia. Exchanging the business intent documents to this effect, in the presence of Indian Prime Minister Dr Manmohan Singh and his Malaysian counterpart, Mohd Najib Tun Abdul Razak, Kiran Mazumdar-Shaw, chairman & managing director, Biocon said, â€œMalaysia is a compelling global destination for biotechnology, backed with world-class infrastructure and attractive tax incentives. Investing in Malaysia provides us with an international location with strategic geographical proximity to India. Biocon is pleased to be an early mover in this emerging opportunity, as we dovetail our research and biomanufacturing operations with those in Malaysia, to gain a global competitive advantage.â€? â€œMalaysia is a compelling global destinationâ€? -Kiran Mazumdar-Shaw, CMD, Biocon Commenting on the prospects of doing business in Malaysia, Kiran Mazumdar-Shaw chairman & managing director, Biocon, said, â€œMalaysia is a compelling global destination for biotechnology, backed with world-class infrastructure and attractive tax incentives. Investing in Malaysia provides us an international location with strategic geographical proximity to India. Biocon is pleased to be an early mover in this emerging opportunity, as we dovetail our research and biomanufacturing operations with those in Malaysia, to gain a global competitive advantage.â€? Mazumdar-Shaw added that the project would focus on R&D and production of high-end biosimilars and other biopharmaceutical products. The investment is the largest for the Malaysian biotechnology sector thus far. In the first phase, Biocon proposes to invest about 720 crore (RM500 million) in this facility, that is targeted to be operational by 2014. The Biocon project would focus on R&D and production of high-end biosimilars ,besides other biopharmaceutical products. The investment is the largest for Malaysian biotechnology sector, so far. In the first phase, Biocon proposes to invest about 720 crore ($161 million) in the facility, which is slated to be operational by 2014. Early movers In a span of four years, India has become the fourth largest investor in biotechnology space in Malaysia, with five companies having established operations there - Stempeutics Research, Aurigene Discovery Technologies, Suvarna Rekha Marines, Geneflux Biosciences and Vivio Bio Tech. While Avesthagen is working with Inno Biologics, a leading local contract manufacturing company. Suvarna Rekha Marines, an aquaculture biotechnology company based in Visakhapatnam (Andhra Pradesh) is an early mover in setting up operations in Malaysia. Since 2006, the company has been involved in aquaculture biotechnology R&D, and the commercial cultivation of the fresh water prawn Macrobrachium rosenbergii, also known as the Giant Malaysian Freshwater Prawn; and locally known as 'Udang Galah' in Malaysia. Incentives for biotechnology companies A company that is into biotechnology activity and has been approved with BioNexus Status by the Malaysian Biotechnology Corporation is eligible for the following incentives: ► An exemption from tax on 100% statutory income for 10 years of assessment, from the first year the company derived statutory income from the new business; or for five years of assessment from the first year the company derived statutory income from the existing business and expansion project; ► An exemption of 100% statutory income, derived from a new business or an expansion project that is equivalent to an allowance of 100% of qualifying capital expenditure incurred for five years. ► A BioNexus Status company is entitled to a concessionary tax rate of 20% on statutory income, from qualifying activities for 10 years, upon expiry of the tax exemption period ► Tax exemption on dividends distributed by a BioNexus status company; Exemption of import duty and sales tax on raw materials/components and machinery and equipment; ► Double deduction on expenditure incurred for R&D; and for the promotion of exports; ► Buildings used solely for the purpose of biotechnology activities will be eligible for Industrial Building Allowance, to be claimed over a period of 10 years. Source:Malaysian Industry Development Authority Bangalore-based Geneflux Biosciences, a technology-driven molecular diagnostics company, has been involved in product-oriented research, development and manufacturing of molecular diagnostic kits in Malaysia. Since 2007, it has invested about 9 crore ($2 million) on infrastructure, international business development and marketing expansion strategies. â€œWe have a state-of-the-art molecular diagnostic laboratory in Malaysia, supported by a small team of Bioinformaticians in India,â€? said Dr Prashanth Bagali, director & senior vice president (Science & Technology) & COO, Geneflux (India & Malaysia). â€œThe company has ISO9001:2008 certification, and is being audited for IEC/ISO 17025:2005 accreditation. Recently, we enrolled into â€œRCPA Quality Assurance Programs Private Limitedâ€?, Australia; and have participated in inter-laboratory quality assurance scheme, conducted by Institute of Medical research (IMR), Malaysia,â€? he added. Geneflux that received â€œ2010 Asia Pacific Frost & Sullivan Niche Company of the Year Award in Molecular Diagnosticsâ€? has a niche benefit and competitive edge for being both manufacturer and service provider of molecular diagnostics kits. It has developed six PCR-based products, namely MyDENKit (dengue virus detection and serotyping), MursaFlux (Methicillin resistance staphylococcus aureus identification), FluFinder (H1N1 virus identification), MyCMV (Cytomegalo virus detection), Chikungunya virus detection kit and Meliokit (Melioidosis caused by Burkholderia pseudomaleii detection), that are being marketed in Malaysia and abroad. It also provides qualitative and quantitative diagnostic services for hepatitis B, hepatitis C, HSV 1 and 2 (human simplex virus), VZV, HIV and other infectious diseases caused by virus and bacteria. â€œWe will increase sales in ASEAN countriesâ€? -Dr Prashanth Bagali, director, senior VP - science & technology & COO, Geneflux India and Malaysia Q Has Geneflux received any support from Malaysian government agency? Geneflux, in association with a Malaysian university, launched the world's first PCR-based commercial kit, MyDENKit (acronym for Malaysian Dengue Kit) during BioMalaysia 2008 conference. Geneflux was awarded the â€œBioNexus Statusâ€? by the Malaysia Biotechnology Corporation. In 2008, MOSTI (Ministry of Science, Technology and Innovation) recognized our â€œpassion for scienceâ€? and granted 1.2 crore (MYR815,000) for the pre-commercial development of MyDENKit, and clinical trials at eight international research centers across dengue epidemic regions. In 2009, MOSTI recognized our contribution and awarded a â€œCertificate of Achievementâ€? for the successful completion of dengue project. In 2009, we received the second round of funding of 3.1 crore (MYR2.5 million) from Malaysian Biotechnology Corporation (BiotechCorp), that boosted our strength, and we became champions in molecular diagnostics production and services. Recently, we received the â€œ2010 Asia Pacific Frost & Sullivan Niche Company of the Year Award in Molecular Diagnosticsâ€?. Q What are your future plans for the Malaysian operations? We will invest in international business development to increase sales within â€œFree Trade Zoneâ€? of ASEAN countries. We will collaborate with American and European diagnostic companies for the development of kits and transfer of technology, to reduce time to market for diagnostic kits. We offer diagnostic services on 30 different tests; and will increase the number of tests to 50 diseases (or microbes) by the end of year 2011. We are looking for partners in ASEAN countries for distribution and marketing of our diagnostic products Bangalore-based Stempeutics Research, a group company of Manipal Education & Medical Group, opened the first-of-its-kind stem cell research facility in Malaysia, citing the ease in getting early approvals. Since its inception in 2008, Stempeutics has been working together with leading medical institutions in Malaysia, to drive long-term research activities to further strengthen its leadership position in the area of stem cell research. As a result of collaborative efforts, Stempeutics Research announced in May 2010 that it has received clearance from Medical Research and Ethics Committee, Ministry of Health, Malaysia, for conducting human clinical trials in patients with ischemic cerebral stroke (CS), using investigational new drug (IND)-based on Mesenchymal Stem Cells, derived from donated bone marrow. Stempeutics became the first international company in Malaysia to get the BioNexus status by BiotechCorp. Also it has received National Pharmaceutical Control Bureau (NPCB) certification for its manufacturing facility for conforming to the requirement of current good manufacturing practices (cGMP), in accordance with the Pharmaceutical Inspection Co-operation Scheme (PIC/S) GMP guides and its relevant annexes for Isolation, Processing and Storage of Mesenchymal Stem Cells. Stempeutics is the first stem cell company in Malaysia to have obtained this conformance certification. Indian companies in Malaysia Company Areas Started in Stempeutics Research Stem cell research 2008 Aurigene Discovery Technologies Drug discovery research and services 2008 Suvarna Rekha Marines Aquaculture biotechnology 2006 Geneflux Biosciences Molecular diagnostics 2007 Vivio Bio Tech Animal testing lab 2010 Avesthagen Biomanufacturing 2010 Biocon Biomanufacturing and R&D Another Bangalore-based Aurigene Discovery Technologies, a 100 percent subsidiary of Dr Reddy's Laboratories too, opened operations in Malaysia in 2008. Aurigene works exclusively with partners on a project for different stages of drug discovery called Hit Generation, Lead Generation, Lead Optimization and Pre-Clinical development. Aurigene has a unique hybrid model, where it is able to run a profitable operation on the strength of its risk-sharing early partnership deals, and therefore, has a sustainable business model with the potential to generate long-term value. In March, 2010, Avesthagen, a leading systems biology biotechnology company from Bangalore commenced manufacture of two of its biosimilars at Inno Biologics, a leading contract manufacturing company in Malaysia. â€œWe are currently carrying out cGMP manufacturing of our first biosimilar product, AVDESP for clinical trials at Inno Biologics facility. The second biosimilar, AVENT will also be produced for clinical quantities in Inno Biologics,â€? says Dr Villoo Morawala Patell, founder, chairperson & managing director, Avesthagen. “Malaysian facility offers improved manufacturing efficiency” —Dr Villoo Morawala Patell, founder and CMD, Avesthagen Q What are the driving factors for Avesthagen to invest in Malaysia? Avesthagen has been fortunate to work with a contract manufacturing organization (CMO) in Malaysia that has a manufacturing capability of mammalian cell-based biologicals, in conformation with FDA and European c-GMP guidelines The Malaysian facility offers improved manufacturing efficiency The willingness of the Malaysian facility to be flexible and adapt to Avesthagen’s needs, has been very helpful. Manufacturing in Malaysia has offered a very important advantage, it is compliant with The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and US Food & Drug Administration (FDA) guidelines, for all manufacturing activities. Q Any support Avesthagen has received from the Malaysian government? The facility being used by Avesthagen, Inno Biologics, is a government facility. Besides that, there is indeed significant support from the government to obtain clearances and other licensing support. Q What are your future plans for the Malaysian operations? Avesthagen will initially focus on completion of clinical batches of the first two molecules. With the support extended by Inno Biologics and the Malaysian government, the relationship with Malaysia is sure to be that of long lasting mutual benefit. Avesthagen has built a robust pipeline of eight biosimilars — of which four are in an advanced stage of development. The first product for anaemia, AVDESP has already completed preclinicals, and is ready for cGMP manufacturing for conducting clinical trials in India. The second biosimilar for auto-immune disorders, AVENT, will also be produced at the Inno Biologics facility. Inno Biologics has been contracted to produce clinical grade material of Avesthagen’s biosimilars, which will be used for human trials. Vivo Bio Tech, a biotechnology company from Hyderabad, plans to set up a biotechnology laboratory in Malacca, a state in southern Malaysia, that will test medications for cancer and diabetes. Trial medicines will be tested on dogs, primates and other animals. The company says it plans to import beagles from Holland and capture primates from the local area. The facility is a 630 crore ($141 million) joint-venture (JV) between Vivo Biotech, state government-owned Melaka Biotech Holdings and a local company, Vanguard Creative Technologies. Despite stiff resistance from animal rights groups, Malaysia has no laws overseeing the testing on animals, the Malacca State Chief Minister Mr Mohamad Ali Rustam is proud to have the lab in his state. Mumbai-based Actis Biologics, a biotech venture technology company focusing on life sciences sector, plans to set up a biotech park called Biocity in Melaka, for which it has been allotted 270 acres of land. Biocity would provide buildings and other facilities for biotech companies. It is talking to a few real estate developers and investors to partner with the Biocity, which is at present on hold, due to real estate issues, and after effects of economic slowdown. Actis is planing to set up the first phase of Biocity, at an investment of 4500 crore ($1 billion), to house about 25 units in a 270-acre area. In the second phase, involving an investment of another 6700 crore ($1.5 billion), it plans to house 40-50 units. The Malaysian government had earlier assured to provide 500 acres adjacent to the first phase. Eyeing lucrative market Malaysia is positioning itself as a cost-competitive country and a regional hub for global biotechnology companies. It is drawing Indian companies — with tax incentives such as 10-year tax holiday, duty exemptions, customized incentives for large investments, access to Association of Southeast Asian Nations (ASEAN) markets through Free Trade Agreements, and no restrictions on equity. Regulations in Malaysia are flexible and guidelines are evolving. This provides a scope for early movers. The regulatory approvals for stem cell research takes about seven months in Malaysia as against 18 months in India. Besides, Malaysia’s membership of ASEAN and Organization of Islamic Conference (OIC) provides scope of marketing products in the member states of these associations. Malaysian Biotechnology Corporation (BiotechCorp), the lead development agency for the biotechnology industry has been showcasing initiatives mooted by the government, and incentive schemes offered to companies, in different countries including India. By participating in leading bio exhibitions like Bangalore India Bio and road shows in Chennai and Hyderabad, BiotechCorp has succeeded in drawing the attention of Indian companies. While some companies have already made investments, others including India’s leading biotech company, Biocon announced strategic foreign direct investment (FDI) in Malaysia. He further added “Malaysia hopes the Biocon investment will stimulate growth for the sector, and provide commercial opportunities for Malaysian biotechnology’s small and medium enterprises (SMEs). Narayan Kulkarni in Bangalore ]]> <![CDATA[Spanish biotech industry thinks global]]> https://biospectrumindia.com/news/95/5459/spanish-biotech-industry-thinks-global.html https://biospectrumindia.com/news/95/5459/spanish-biotech-industry-thinks-global.html Thu, 04 Nov 2010 15:40:00 +0530 By gaining global attention and government support, BioSpain 2010, the international business meet on biotechnology, has become the most important biotechnology industry event in Southern Europe Biotechnology is emerging as a key area that drives economic growth in Spain. In terms of scientific production, Spain is ranked fourth in Europe. In this context, BioSpain 2010 witnessed a sizeable participation by major biotechnology companies of Europe and the US. This biannual event organized by Spanish Association of Biocompanies (ASEBIO) in collaboration with the Government of Navarre, through the Navarre Development Association (SODENA), with the aim of augmenting the growth of biotechnology sector in Spain, was held from September 29-October 1, 2010 at Pamplona. Government Support Over 1,300 delegates from various countries attended the event. About 2,000 business meetings including 600 with companies, were part of BioSpain 2010. While acknowledging government support, Jose Maria Fernandez Sousa Faro, chairman, ASEBIO, said, “With its encouragement for the growth of biotechnology sector in Spain, the government of Navarre has been a perfect ally for organizing this global event, BioSpain 2010.” Addressing the gathering, Jose Maria Roig Aldasoro, regional minister, Department of Innovation, Business and Employment, Government of Navarre, said, “The biotechnology sector has established its presence in Navarre, and we are determined to strengthen it further, in order to diversify business activities and also to create more job opportunities.” Biotech funding During this event, ASEBIO stressed that Spain needs to align itself to the European Union’s strategy on bioeconomy. According to the Ministry of Science & Innovation, Government of Spain, by the end of 2010, the biotechnology sector will contribute 1.2 percent to national GDP. In order to drive growth in biotechnology sector, the Ministry of Science & Innovation has granted $145.38 million (647 crore) in 2009. “Investment in biotechnology R&D is crucial to prevent our best researchers from moving abroad. Navarre is keen to encourage biotechnology sector, and the proof for that is the enormous interest it showed in organizing BioSpain 2010,” said José María Fernández Sousa-Faro, president of ASEBIO. “The biotechnology sector in Spain has taken important steps during the recent years, and we should not allow the repercussion of economic crises to affect that progress. Spanish companies should gain global recognition in order to attract funding from outside Spain. To achieve this, Spanish biotechnology companies should participate in international fairs like BioChicago, to gain more exposure,” said Fernández Sousa. Spain is currently the second Organization for Economic Co-operation and Development (OECD) country that dedicates most of its public resources to R&D in health, after the US. According to the latest statistics by Spanish National Statistics Institute, there are more than 200 exclusive biotechnolgy companies in Spain, and over 700 companies that perform biotechnological related activities, an increase of over 38 percent with respect to 2005. This spectacular growth of the Spanish biotechnology industry is the result of the different public and private initiatives taken to bridge the gaps between industries and researchers to create bioclusters. With all these new initiatives taken by the ASEBIO with the backing of the government of Spain, the Spanish biotechnology is expected to gain global recognition. ]]> <![CDATA[Excellent platform for analytical sciences, lab services]]> https://biospectrumindia.com/news/95/1499/excellent-platform-for-analytical-sciences-lab-services.html https://biospectrumindia.com/news/95/1499/excellent-platform-for-analytical-sciences-lab-services.html Thu, 04 Nov 2010 15:39:00 +0530 The second edition of India Lab Expo and Conference, said to be the biggest lab exhibition in South Asia, will showcase the latest analytical equipments, instrumentation and services in all major areas of analytical sciences and laboratory services. The event provides an opportunity for presentation of the latest state-of-the-art technology in the field. INDIA LAB EXPO December 10-12, 2010 Pragati Maidan, New Delhi The aim of the exhibition is to provide a platform for business developments, marketing and open new avenues for transfer of technologies to motivated entrepreneurs and the scientific fraternity. About 250 exhibitors and 6,000 visitors are expected to attend. The exhibitor profile includes laboratory, analytical, biotechnology, microbiology, clinical lab, pathology, diagnostic, medical lab, educational lab and optical instruments. Apart from such instruments, lab chemicals, lab furniture, lab glassware, lab plastic ware, filtration, software and liquid handling products manufacturers and distributors are also participating in this mega event. The event also has a knowledge sharing and networking opportunity with a two-day conference. The conference is expected to attract 200 delegates, and provide a scientific and educational platform for laboratory professionals who seek an update in their area of specialization. Currently, the organizers are compiling a comprehensive and diverse technical program, including three different sessions on analytical instrumentation, clinical research, biotechnology and physics. Topics like good laboratory practices and overview of laboratory introduction management systems will cover the talk sessions. Vivek Vikram, managing partner, ScientificDealers.Com, said,“We are pretty sure that this exhibition will cater to a wide range of inquiries, which will certainly boost the business of the participants. We have a sudden feeling of excitement that the region’s scientific and laboratory manufacturers, once again, choose India Lab Expo as a platform for seeking regional and international partners in this rapidly growing sector.” A large number of scientists and decision-makers from pharmaceutical, healthcare, life sciences, biotechnology industries are likely to participate; besides hospitals, pathological and clinical trials labs and trade suppliers. ]]> <![CDATA[BioSpectrum student lecture series @ Oxford College of Science, Bangalore]]> https://biospectrumindia.com/news/95/2040/biospectrum-student-lecture-series-oxford-college-of-science-bangalore.html https://biospectrumindia.com/news/95/2040/biospectrum-student-lecture-series-oxford-college-of-science-bangalore.html Thu, 04 Nov 2010 15:34:00 +0530 Lighting the lamp of knowledge: Narasimha Raju, executive director, Oxford Educational Institutions, inaugurates the BioSpectrum-Oxford College Lecture Series by lighting the lamp. Narayanan Suresh (Left), group editor, BioSpectrum, looks on The event titled 'Exploring Entrepreneurship & Corporate Opportunities - Getting started on the career ladder' was held on October 13, 2010 at The Oxford College of Science campus in Bangalore. The spacious conference room of the Oxford College campus was fully-packed with 700 vibrant students from top life sciences colleges in Bangalore. Speakers from all verticals of the life sciences industry addressed the gathering. The sessions were divided into five key topics - Opportunities in Biotech, Pharma and CRO; What it takes to be a biotech entrepreneur?; Preparing for the industry; Opportunities in BioIT; and Opportunities in Supplier Industry. Catch-up with the trends During his inaugural speech, Narayanan Suresh, group editor, BioSpectrum, gave a detailed brief on the evolution of life sciences industry in India, its consistent growth and the potential it has for the future. He gave insights on the emerging trends and promising areas of focus, to build a strong career in life sciences. He also shared the consistent efforts made by BioSpectrum over the past seven years, in covering major trends and developments in the life sciences industry. BEST for students Opening keynote speaker Dr Satya Dash, chief operating officer, Association of Biotechnology Led Enterprises (ABLE) gave insights on the various career options available to biotechnology students, after graduation. He enlightened budding entrepreneurs about ABLE's business program for students - Biotechnology Entrepreneurship Student Teams (BEST). Held in conjunction with the Department of Biotechnology (DBT), BEST encourages college students to develop business plans and execute them in a competition, where the best ideas win awards. Opportunities in life sciences The first session of the event deliberated on the growing opportunities in the life sciences sector. The speakers impressed the students by opening wider horizons of opportunity available to them, and put forth ways to prepare for it. Think outside-the-box Dr Sridhar Ramanathan, executive director, ReaMetrix, suggesting ways to gain recognition in the industry, told the students to think outside-the-box. â€œBe creative, execute ideas proficiently, and show eagerness to solve problems in science. These are the three necessary qualities for success. In order to make it big in the industry, one must fit into any role that the company demands; and be open to learning new things,â€? he added. Clinical research is not rocket science Dr KH Ramanjaneya, managing director, SMO India, gave the participants an idea of what exactly happens in the clinical research field, and the key domains involved. He elucidated that clinical research is not rocket science; and those who study science can master it. He also briefed students on the prospects of Indian clinical research organization (CRO) sector; and added that the key to success lies in right education, experience and exposure-obtained through proper training. Pay heed to experts Welcoming the gathering, Narasimha Raju, executive director, Oxford Educational Institutions, said that the lecture sessions would provide an excellent platform in knowledge sharing for life sciences students. He urged the students to make good use of the valuable guidance by the industry experts, for the benefit of their future. What it takes to be a biotech entrepreneur? The second session of the day gave students vital information on how to start a business, and go on to become successful biotechnology entrepreneurs. The speakers in this session shared their entrepreneurial experience with students. Be ready to take risk Dr Shama Bhat, managing director, Bhat Biotech, began the session on entrepreneurial skills with insight on the procedures to be followed while starting an enterprise. He shared his experience on the challenges faced by start-up companies, and ways to tackle them. He also stressed the need to gain domain expertise, and gave tips on ways to develop an unique identity in the market. Surety brings success The second speaker, Dr Ajay Bharadwaj, CEO, Anthem Biosciences, gave insights on how to be a successful biotechnology entrepreneur. He advised students to begin their career in start-up companies, because this would give them the best exposure, and in-turn, provide a tremendous learning experience. He also went on to say that to survive in this industry, one must educate oneself and ensure that constant learning takes place. He asked the students to be sure about what they do - both in personal and professional life, to gain success. Preparing for the industry The third session of the day imparted valuable insights by human resources heads of prominent biotech companies. High demand for competitive leaders â€œPlenty of talent is available at the entry level - this has to be groomed and honed properly. There are many attractive jobs with better salaries available for talented people. Many finishing schools are available for students to make use of the booming opportunitiesâ€?, said Ravi Dasgupta, head of HR, Biocon. He also said that life sciences students can opt for jobs in areas of R&D; operations; quality control and assurance; regulatory; sales and marketing; clinical research; intellectual property (IP) and law; project management; and administration. Gen Y needs a wake up call Thomas Putti, head, HR, Advinus, emphasized the need to bridge the expectation gap that exists between industry and generation Y (the new generation of students/job seekers). â€œHarmony is important in the workplace, as people work in a team to achieve the common goal of a company. There must be a compromise that has to be made, to function efficiently in the business world. As students, you should work on improvising your key skillsâ€? he said. In order to make students industry-ready, Advinus has started a finishing school to train students. In order to get the right job, one must have the right attitude, right knowledge and right skill,â€? he emphasized. Opportunities in BioIT Dr Anand Kumar, CMD, Cellworks, took over the stage for the fourth session that focused on opportunities in BioIT. He was highly optimistic about the opportunities that youngsters these days have for themselves, and went on to call this generation, â€œthe innovating generationâ€?. Make the country proud Dr Kumar urged students to be flexible in order to grow and become successful. He informed students of the tremendous scope for young graduates these days; and how they must make use of it and excel, to make India the biggest pharmaceutical market in the world. He asked students to be familiar with patents and IP, and capitalize on their work to bring India the recognition and growth that is due. Opportunities in supplier industry Commenting on the opportunities in the supplier industry, Sekhar Ayyala, director of life sciences, Pall India, said, â€œJob openings for life sciences students are unlimited in India, as the life sciences sector, backed by the growth of biotechnology and pharmaceutical sectors, provides great opportunity. Biosupplier sector is one of the promising sectors that provides career scope for freshers.â€? Mold as per need Ayyala stressed the need for developing the talent pool for growing opportunities. â€œCompanies expect certain quality from students. Freshers need to upgrade their skills as per the demand of the industry, to withstand competition. Educational institutes should work toward imparting industry-orientation; bridge gaps between theoretical and practical knowledge; provide training for enhancing multi-tasking skills of students; strengthen academia-industry partnership; and create awareness of the trends in industry and the economy of the country,â€? said Ayyala. The end of each session saw students participate in an interactive Q&A session. The event concluded with a closing address by Suresh, who insisted the students make the most of the wide array of opportunities that are available. He also declared five lucky winners from the participants, and gifted them with one-year free subscription to BioSpectrum magazine. The energy and enthusiasm of the students, evident at the event, reflected the promising future for the life sciences sector in India, led by this new generation of budding entrepreneurs. - Pradeep Kumar & Martina Andrea D'Couto ]]> <![CDATA["Capitalizing on growth opportunities in India"]]> https://biospectrumindia.com/news/95/1031/capitalizing-on-growth-opportunities-in-india.html https://biospectrumindia.com/news/95/1031/capitalizing-on-growth-opportunities-in-india.html Thu, 04 Nov 2010 15:30:00 +0530 – Amit Agarwal, vice president & general manager, Cole-Parmer In an open dialogue with BioSpectrum, Amit Agarwal, vice president & general manager, Cole-Parmer, describes the company’s strategy and expansion plans for India. Q What is Cole-Parmer’s strategy and expansion plans for India? Cole-Parmer established its presence in India in 2007. Prior to that, we did not have a direct presence—our dealer in India was Ultrapure Scientific. In 2007, we acquired Ultrapure Scientific, and renamed Cole-Parmer India. Since then, we have seen significant growth — our sales has more than doubled in three years. But in India, when you have a focused business, you can grow significantly. Yet compared to the market opportunities in India, our footprint is still very small. Hence, our expansion plans for India are significant. We are aggressively looking at growth in terms of people — sales resources, application support resource and customer services. Another area for expansion is our product portfolio. Presently in India, the type of products we sell comes directly from the US. With India improving the production of analytical instruments and process-oriented products, we are considering opportunities in which we could source the same products locally from here — for both Indian and outside markets. These expansion plans will give us a broader customer base. Q Since the time Cole-Parmer established a direct presence in India, how favorable has the market been? For Cole-Parmer, India has more advantages than disadvantages. One of the advantages is that we have a strong presence in biopharmaceutical and bioservices markets. Today, around 40 percent of the business comes from biopharmaceuticals, while the remaining 60 percent from academics and the process industry. India has a huge biopharmaceutical market with the production of generic drugs. Around 30 percent of drug patents in the US will expire soon and give way to generic drugs. The two countries that lead in generic drug production are India and Israel. In the coming years, more drug production volume will move to India. In bioservices, most of the clinical trials take place in India because, genetically, the Indian population is a lot similar to the population in the US. The main challenge is that pharmaceutical companies — our customers — are still restless about patent- protection and intellectual property (IP) guidelines in India. They are not yet in line with the Western markets, and are still wary about having their production facilities in India. For the time being, they bring in a great deal of R&D, but it will take some time before they scale up their production in India, like they have done in the US and Switzerland. Q How does Cole-Parmer view Mergers & Acquisitions with local partners in India? Our parent company has made a number of strategic acquisitions over the years — large and small. We are always evaluating acquisition opportunities. Q What is Cole-Parmer’s market share in India, and the target for the coming years? In India, Cole-Parmer’s market penetration is still not so significant. Presently, we do not have a target market share in mind. But, we are looking for a strategy that would result in 15-to-20 percent growth each year. We have found our sweet spot in India — biopharmaceutical and bioservices segments. Today, we sell certain types of products in India, but in Europe and the US, we sell a wider portfolio of products. Our idea is that, over a period of time, we should be able to sell a similar range of products in India as well. Q Any plans for new product launches in India in the coming year? A catalog specifically for India is planned for release in May 2011, containing many new products. Globally, we release a general Cole-Parmer product catalog every two years, and a new issue will be available in March. It contains approximately 10,000 new items — mainly catering to the pharmaceutical, academics, food and agriculture sectors. In addition, once new products are released, they are listed on our company website. Cole-Parmer has a huge online web presence in the US, but not as much in India — though it is gaining in popularity. Making India’s website robust is a key project we are working on. Q How do you intend to make your website more robust in India? Has the culture of online browsing and transactions of scientific products picked up in India? We are working to increase the content of our website in India. The level of our investment in the next year is to develop the Cole-Parmer India website to the same scale as the US version. The culture of scientists and researchers looking online for products, rather than reading a brochure, is picking up in India. Some studies reveal that 47 percent of the scientific community in India browse websites  for products. Half the 47 percent generate transactions with the presence of young employees.  In China, only 30 percent browse websites; and only five-to-10 percent make a transaction. Q Globally, are there any new applications or channels that Cole-Parmer is working on? Cole-Parmer delivers strong technical assistance to our customers. One of our most popular application tools is our Chemical Compatibility database. This is a database of chemicals and substances that show which are compatible with each other and which, when mixed, can cause a reaction. We have this database on our website. In the US, we are now developing an iPhone application for the database, and testing it. This application will enable scientists and researchers to access the database from their iPhones, and check the compatibility of their chemicals. We will be launching this within a month in the US. Q What has been Cole-Parmer’s performance in Asia Pacific region? In Asia Pacific (APAC), we have been growing at about 30 percent. India is in line with overall APAC growth. India and China have been experiencing significant growth, along with South Korea and Japan. In China, we do not have a direct presence, but work through dealers. Therefore, our growth rate there is slightly less than that of India. We are also seeing some significant growth in Australia. On the whole, globally, the three regions where we are focusing our strategy are the markets in China, Brazil and Eastern Europe. Q Could you share your views on some of the market trends in APAC region? There is a lot of R&D happening in APAC region. Traditionally, China was the manufacturing hub of the world; while India had a forte in services. Earlier, multinational companies preferred to conduct R&D activities in their respective countries, and then bring in production to these regions. But now that has changed and, on the whole, a lot of clinical trials are moving to APAC region. This is a strategic fit for Cole-Parmer. Q What are your future plans for India? Our goal is to grow 20-25 percent in India. We will be investing in people, including marketing, sales and application support functions. And lastly, our focus would be to have a stronger web presence in India. Nayantara Som ]]> <![CDATA["I hope to see more women rise to the top"]]> https://biospectrumindia.com/news/95/2687/i-hope-to-see-more-women-rise-to-the-top.html https://biospectrumindia.com/news/95/2687/i-hope-to-see-more-women-rise-to-the-top.html Thu, 04 Nov 2010 15:21:00 +0530 —Dr KR Rajyashri, Founder & director, Navya Biologicals, Hubli (Karnataka) Dr Rajyashri has filed five patents. A published author, Dr Rajyashri shares insights on the challenges she faced in her career, and the opportunities for women in the life sciences industry Q What type of challenges did you face during the initial stage of your career? The biggest challenge I faced during the initial years of my career was in finding a balance between family and career. As a young mother, I was eager to be with my daughter as she was growing. Yet, I chose to continue with my career and was not sure if I will be able to manage both. My passion for science did not allow me to give up my career. However, I was happy when my daughter, one day, told me that she is proud of her mother being a scientist. Q What according to you are the difficulties women face in the life sciences industry? Today, more women than men seem to take to science. Many women voluntarily put a hold on their career for other priorities, and so we do not see many women in leadership positions. Life science is not a part-time job where you can go home and switch off. You carry your scientific problems home, have to read after work hours, be part of peer and discussion groups; and be aware of the latest developments in science. Setting priorities right and multi-tasking are the only ways for women to be able to balance work and family. At Navya, we strive to encourage and support young girls starting on their career, and inspire them to take up leadership positions. Q How do you balance family and work issues? In my initial days, it was extremely tough to strike a balance but now, I am able to achieve a good balance. My family encourages all my efforts. My business partner, Vinay, is tremendously supportive at work. Q Considering your vast experience in life sciences industry, how do you see women in this industry in the next five years?   About 60 percent of women take up science at the college level. And not all of them start a career in their field after college. That is one of the reasons why few women reach leadership roles. I hope to see more women become leaders, and rise to the top in the next few years. ]]> <![CDATA["Life sciences industry is supportive to women"]]> https://biospectrumindia.com/news/95/8089/life-sciences-industry-is-supportive-to-women.html https://biospectrumindia.com/news/95/8089/life-sciences-industry-is-supportive-to-women.html Thu, 04 Nov 2010 15:19:00 +0530 —Dr Saral Thangam, Managing Director, Norwich Clinical Services, Bangalore Dr Saral Thangam, a winner of awards—such as Indian Council of Medical Research’s (ICMR) Shakuntala Amirchand Award—for significant contribution to biomedical sciences has several publications to her credit in national and international journals. Here Dr Thangam shares her achievements as an entrepreneur Q How did you tackle challenges during the initial stage of your career? I am a physician trained in Christian Medical College, Vellore. As a woman doctor I have successfully followed many role models. Many women have excelled in the medical field, an area that has been very supportive to women. Q What has been your formula for success? I enjoy my work every moment.  I believe that remaining grateful for the opportunities that we have, brings greater opportunities. Q As a leader, what are the challenges in running a business in the life sciences industry? Being a leader in the life sciences industry in the current global economic scenario is a challenge. In order to run a business successfully, as a leader, one has to attract and retain clients, talent; visualize and evolve a strategy for growth and opportunity at every level. Q How do you manage family and work together? Balancing work and home is a challenge. Most women are better at multi-tasking and have the ability to stay focused at work, while also supporting, nurturing and caring for their families. At the end of the day, we each find a balance that we are happy about. Q How can women emerge as leaders in life sciences industry? The life sciences industry employs women at different capacities and provides a woman-friendly environment. I do not believe that there is any specific discrimination against women in this industry. However, there are several jobs in the life sciences sector that require staff to be present at night and after-hours. These are by nature difficult for women especially those with families to care for. In my present and previous positions, I have had the privilege to work with many women, several of whom were in top positions. The key is to remain sensitive to women in order to encourage their growth. Q How do you see women in life sciences industry in the next five years? There are several highly-qualified women in this industry with excellent track record. I believe that women have a great future in this industry. Q Could you suggest five tips to become a successful entrepreneur? To become a successful entrepreneur one needs to show willingness to take risks, be self-confident, work hard, care for people around us, and have an urge to do things at the appropriate time. ]]> <![CDATA[Acceptance levels of women are higher now]]> https://biospectrumindia.com/news/95/1494/acceptance-levels-of-women-are-higher-now.html https://biospectrumindia.com/news/95/1494/acceptance-levels-of-women-are-higher-now.html Thu, 04 Nov 2010 15:18:00 +0530 —Dr Radhika Bobba, Director (Medical Services), Stempeutics; partner & founder, Anhvita BioPharma Consulting, Bangalore An active member of Drug Information Association, India; and Indian Society for Clinical Research, Dr Bobba is actively working with regulatory bodies to strengthen the Indian regulatory policy in line with international recommendations Q What challenges did you face as a woman during the initial stage of your career? When I joined the industry, in the early 1990s, there were few women in the middle and senior management positions. Certain gender biases were prevalent. I did overcome that when colleagues and bosses realized the seriousness with which I approached the tasks assigned to me. Q What is the secret behind your successful career? The most important factor for my success is my family’s support. I followed an unconventional path — after medical school most of my friends chose academia and clinical subjects; and I was the only one who tried to find a job in the industry. These experiences have been critical in making me an effective team member and a lead. I have a strong drive to offer better patient care, and unafraid to try something new. Q How can a woman effectively run a business at a leadership level in the life sciences industry? The challenges are no longer in running the business but on how to find the time to ensure deliverables are achieved at a consistent high quality, and within the set timelines. There are more women leading by example, and the acceptance levels are higher now. Q How do you see the future for women in the life sciences industry? Women in the life sciences industry are armed with a “can do attitude”, and look for feedback frequently. They need challenges, and organizations should offer a variety of development opportunities. More women will become entrepreneurs and focus on niche specialty areas. This change has been possible because of the burgeoning IT and ITES industry, that has expanded the footprint for women within the industry. Q How do you balance family and work? I am fortunate to have an extremely strong family support. Family-work life balance is complex. Q What are the qualities needed to become a successful entrepreneur? Be passionate about your work, believe in what you do, and focus on what you want to achieve; learn from the job role, know the people around you, and be willing to change; gain the courage to try new things; and step back and look at the big picture though you are an expert at what you do. Financial strength or support is a key factor in aiming to be an entrepreneur. Try to follow science with clinical relevance. Get a wide range of exposure in the field including commercial aspects and finance, discovery, and development. ]]> <![CDATA["Good work environment is critical for success"]]> https://biospectrumindia.com/news/95/8464/good-work-environment-is-critical-for-success.html https://biospectrumindia.com/news/95/8464/good-work-environment-is-critical-for-success.html Thu, 04 Nov 2010 15:08:00 +0530 —Dr Renu Razdan, Chief Operating Officer, Max Neeman International, New Delhi Dr Renu Razdan heads the business development and operations function of the company. In her career, Dr Renu has worked with both Indian and international customers and travels extensively to understand customer requirements in various geographies  Q How did you counter the challenges as a woman during the initial stage  of your career? The main challenge was to fight the stereotype views that society had about the role that women play in the world. This is specific not only to India. The best way to overcome this is to stay committed and focused to your objectives, and persistently try to achieve and excel. Q What are the qualities needed for women while running a business at a leadership level? Basically, women know that the challenges they face are not unique to them. We are a knowledge-based industry, and hence it is important to have an international perspective. Q What has been your formula for success? There are no short-cuts to success. The combination of hard work and the passion to achieve goals will lead you to success. Challenges bring with them a lot of opportunities. I also believe that it is important to work with people who believe in the same principles, and therefore, it is important to create a team that believes in the motto ‘all for one; and one for all’. Additionally, being in a business where we compete with international companies, we have to make sure that we have a team that ardently believes in presenting a great image of India, and deliver excellence. Q What are the measures needed to encourage women in life sciences industry? An environment where their talent and intelligence are nurtured, is critical .to the success of women. Organizations must make sure that equal opportunities exist for women, not only in letter but also in spirit. Hence, creating an environment where their talents and skills are utilized well, is important. A number of women face difficulty in managing a work-life balance. Implementing small but effective changes like flexible office timings for women, can bring promising results. Q How do you see the future for women in life sciences industry? Anyone who is talented, passionate and willing to work hard and think differently, has a great future in this industry. Innovation will be very important in times to come. We must recognize what we are good at, and try to excel in that area. Q Could you suggest five tips for potential entrepreneurs? Risk-taking ability, being passionate about work, willingness to work hard, capability to develop a great team, ability to turn challenges into opportunities can take one ahead. ]]> <![CDATA["Business challenges are not specific to women"]]> https://biospectrumindia.com/news/95/4459/business-challenges-are-not-specific-to-women.html https://biospectrumindia.com/news/95/4459/business-challenges-are-not-specific-to-women.html Thu, 04 Nov 2010 15:06:00 +0530 —Bindhya Cariappa, Director of operations, India & MEA, ClinTec International, Bangalore Bindhya Cariappa has good experience in many clinical development verticals including clinical operations, regulatory affairs, quality assurance, medical writing and training across India and Europe. She has been responsible for over 100 phase I-IV clinical trials conducted in 28 countries worldwide. Q What are the inspiring factors that contribute to your success? I believe the essential elements of a successful business are motivated professionals, good understanding of client requirements, operating with integrity, adaptability to change, commitment to innovation and pride in delivering excellence. Q What management principle do you follow while heading operations of a company like ClinTec International? ClinTec International is in an aggressive growth phase, and heading its operations entails evaluating and implementing strategies that enable sustainable growth within newer functional verticals, while evaluating and strengthening the core capabilities. As a result, my focus areas are staff, clients and quality. We attract and engage the best talent in the company and empower them to achieve. I believe in accountability, fairness, transparency, equal opportunities, recognizing achievements of employees and encouraging innovation and entrepreneurship. Our policies and procedures reflect these principles. Q What are the challenges you face ? We face many challenges while running a business, but I have not come across any that are as a result of being a woman. Through experience, I say that the business area we operate in is a level playing field with performance being the key success criteria. Q What are your plans for the future? Being in charge of leadership and operational roles across a wide geographic area, I do see myself moving into a more strategic and global role in the near future. Q Can you share your learning for the benefit of women who aspire to become entrepreneurs? In my experience and by interacting with a large number of successful business women and entrepreneurs, I could identify a few common traits — those include passion and perseverance to succeed, with the flexibility to adapt and importantly, perceptiveness in identifying and seizing emerging opportunities. ]]> <![CDATA["Right team, commitment to work bring success"]]> https://biospectrumindia.com/news/95/2119/right-team-commitment-to-work-bring-success.html https://biospectrumindia.com/news/95/2119/right-team-commitment-to-work-bring-success.html Thu, 04 Nov 2010 14:59:00 +0530 -Anuradha Acharya, CEO, Ocimum Biosolutions, Hyderabad Perseverance and flexibility helped Anuradha achieve success and her company, Ocimum Biosolutions, acquired three international companies Q What has been your formula for success? Having the right team in place and being very involved and committed to business is my formula for success. Q What are the business strategies that led to the growth of Ocimum Biosolutions? During the initial stages, having the right processes in place is very important for the growth of a company. One must make sure that the process is followed to perfection. And one should also be quick enough to reorient, if processes are not bearing fruit. Q What are your professional goals for the future? My professional growth is related to the progress of my company. My prime goal is to take Ocimum to the next level and/or expand in multiple areas. Right now, we are genomic-focused. We have been working in integrating what we have - from software to hardware to services. The next level would be to acquire competencies in newer areas like clinical or preclinical. That will enhance our capabilities as a clinical research organization. Building further on it would be - generating intellectual property. Q Could you share your learning with other women who aspire to become successful entrepreneurs? As an entrepreneur, I feel a person should never forget the basics of running a business. Firstly, one should create a business that is sustainable. Q What are your aspirations for Ocimum Biosolutions? We want to be a premier R&D outsourcing company. I want Ocimum to achieve 444 crore ($100 million) revenue target in the next three years. To achieve that, we would look into a couple of acquisitions. ]]> <![CDATA["Women face the same challenges as men"]]> https://biospectrumindia.com/news/95/8053/women-face-the-same-challenges-as-men.html https://biospectrumindia.com/news/95/8053/women-face-the-same-challenges-as-men.html Thu, 04 Nov 2010 13:22:00 +0530 —Suchitra K Ella, Co-Founder & Joint Managing Director, Bharat Biotech International, Hyderabad Suchitra’s leadership combined with hands-on approach to work, logical pursuit, attention to detail, and organizational skills have been the driving force for her successful entrepreneurial career Q What are the factors that inspired you to jointly set up a company with your husband, Dr Krishna Ella? Dr Ella was getting trained in molecular biology, microbiology, pharmacology in the US. With a background in economics, I pursued a career in financial services with specializations in marketing and business management. I wanted to return to India, but couldn’t find any challenging assignments due to lack of R&D in the industry. I have a natural urge for risk taking, so I decided to start our own company. Q What kind of management strategy do you follow? For managing the company, I follow transparent and system-driven hierarchy, innovative technology and marketing models. It is important to motivate scientists in R&D to solve public health problems. Q As a woman entrepreneur, what are the challenges you faced in running a business? Women entrepreneurs face the same challenges as men. Entrepreneurship is not gender-based. Q Can you share your learning with budding women entrepreneurs? I have learnt not to compromise on passion and innovation; also think out-of-the-box, and learn from failures. As an entrepreneur, one needs to overcome several challenges such as competition, government hurdles and markets barriers. Q Where do you see Bharat Biotech five years from now? Bharat Biotech will become a strong innovation-driven technology provider in vaccines and biopharma, with emphasis on solving public health concerns related to infectious diseases of the emerging markets and the developing world. The sky is the limit for Bharat Biotech as we are lined up with new molecules, new vaccines, and intellectual property rights. ]]> <![CDATA["Being passionate about success helps a lot"]]> https://biospectrumindia.com/news/95/7953/being-passionate-about-success-helps-a-lot.html https://biospectrumindia.com/news/95/7953/being-passionate-about-success-helps-a-lot.html Thu, 04 Nov 2010 13:16:00 +0530 -Dr Kiran Mazumdar-Shaw, CMD, Biocon, Bangalore Kiran Mazumdar-Shaw ranks among the elite in the global business world. She has been voted The Most Influential Bio-business Person outside Europe and US, by Nature Biotechnology Q According to you, what are the attributes of an entrepreneur? An entrepreneur should have the ability to pursue a business from concept to commercialization, to build a team through shared vision, to take on and manage risks and challenges, to lead by example; and also possess a strong capability in problem solving. Finally, for me, an entrepreneur is one who has a close emotional bond with his/her enterprise, and is passionate about succeeding, no matter how steep the obstacles are. Q What motivates you to excel? To reflect on all our difficult achievements, exciting challenges and promise that our innovation-led programs offer. Q What is the lesson you have learned from any of your mistakes? Never share intellectual property without a confidential disclosure agreement! Q Where do you see Biocon five years from now? I have endeavored to build a global biotechnology company with an Indian DNA. I aim to deliver a novel and differentiated biotechnology drug for patients across the world that can truly plug an unmet need. We have at least three such programs in our pipeline: an oral insulin in a tablet, an antibody for chronic auto-immune diseases that does not flare up infections, and conjugated antibodies that behave as therapeutic cancer vaccines. If any of these succeed, I will have achieved my goal. I certainly see Biocon as one of the top five biotechnology companies in the world in 2020. ]]> <![CDATA[India needs innovation in agri research, education]]> https://biospectrumindia.com/news/95/1872/india-needs-innovation-in-agri-research-education.html https://biospectrumindia.com/news/95/1872/india-needs-innovation-in-agri-research-education.html Thu, 04 Nov 2010 13:12:00 +0530 While inaugurating a meeting of Vice-Chancellors of state, deemed and central agricultural universities from all across India at the National Agricultural Science Center, New Delhi, Dr Montek Singh Ahluwalia, deputy chairman of Planning Commission, Government of India, said, “Innovative approach should be adopted to strengthen agricultural research and education in India. State agricultural universities can play an important role in this direction by providing research-based projects with the help of industry.” Dr Ahluwalia lauded the role played by the National Agricultural Research System in India. He urged agricultural research institutes to re-orient themselves before the 12th Five Year Plan to tackle the challenges of food security and climate change. Referring to the gap in agricultural growth rate and land productivity of China and India, he stressed the need to be more research-based solutions to issues. “Four percent agricultural growth is needed for a growing economy like India. It would require more investment in knowledge management, institutional support and diversification in agriculture, government is also willing to fund such projects,” he added. He suggested a new mechanism to fund research projects instead of funding universities. Dr S Ayyappan, secretary, Department of Agriculture Research and Education (DARE) and director-general, Indian Council of Agricultural Research (ICAR) highlighted the role and contribution made by the ICAR institutes and agricultural universities in developing new technology and seeds for Indian farmers. He expressed confidence in converting some institutes into the center of excellence. Dr RB Lal, president, Indian Agricultural Universities Association, urged for more research covering all aspects of Indian agriculture. NIMR invites academia, industry to genetics lecture The National Institute of Malaria Research (NIMR), New Delhi, in collaboration with Institut Pasteur, Paris, France and Global Health Institute, Switzerland; is organizing a global lecture course on Molecular and Evolutionary Genetics of Malaria from November 21-December 4, 2010 at New Delhi. Researchers from universities, research institutes and the industry are invited to participate in this unique forum to exchange views. The faculty of the course includes the renowned scientists from the US, France, Germany, India, UK and many more countries. The lecture course is expected to benefit researchers both in academia and the industry by providing an opportunity to be up-to-date with the latest knowledge in the area of malarial genetics, and thus, work in the direction of finding newer and better options for malarial drugs. ]]> <![CDATA[Bio-Rad launches SsoFast EvaGreen]]> https://biospectrumindia.com/news/95/2431/bio-rad-launches-ssofast-evagreen.html https://biospectrumindia.com/news/95/2431/bio-rad-launches-ssofast-evagreen.html Thu, 04 Nov 2010 13:11:00 +0530 Bio-Rad Laboratories has introduced SsoFast EvaGreen Supermix with low ROX which enhances the speed, reliability, and sensitivity of qPCR experiments performed on instruments requiring ROX reference dye. The ROX-blended version of the SsoFast EvaGreen supermix is optimized for users of PCR systems that employ ROX as a passive reference for normalization. SsoFast EvaGreen supermix with low ROX can be used effectively on Bio-Rad’s real-time PCR detection systems, as well as on the ABI 7500 Fast and Standard, ABI StepOne and StepOnePlus, and Stratagene MX-series real-time PCR systems. Through instant polymerase activation, optimal primer binding, and rapid polymerization kinetics, SsoFast EvaGreen supermix with low ROX can help researchers reduce their time-to-results from 90 minutes or more, for standard cycling to between 35 and 45 minutes. Millipore unveils CpGenome Turbo kit EMD Millipore, the life sciences division of Merck, Germany, has introduced a rapid kit for bisulfite conversion, which is a critical first step in mapping the differences in genomic DNA methylation patterns. Aberrant DNA methylation can result in inappropriate activation or silencing of specific genes, and is associated with errors in embryonic development as well as onset of diabetes, cancer, cardiovascular and other diseases. The new CpGenome Turbo kit converts unmethylated cytosines to uracil in 90 minutes, which is twice as fast as commonly used bisulfite kits and reagents. By increasing the throughput of bisulfite modification, the CpGenome Turbo kit allows researchers to examine DNA from more samples in less time. It’s conversion reagent reduces incubation times while retaining high efficiency, converting more than 99.9 percent of unmethylated cytosines to uracil. Agilent introduces cytogenetics tool Agilent Technologies introduced the SurePrint G3 Human CGH+SNP microarray platform, an innovative system for simultaneous analysis of chromosomal copy number changes and copy-neutral aberrations. The system allows researchers to study the genetic basis of developmental disorders as well as many cancers. This is said to be the only two-color CGH platform that can detect loss of heterozygosity/uniparental disomy (LOH/UPD) with five to 10 megabase resolution. The SurePrint G3 CGH+SNP microarrays use the identical high-throughput workflow as the current CGH-only microarrays, so they can be simply and efficiently incorporated into cytogenetic research. Agilent’s Genomic Workbench software compliments array analysis by employing novel algorithms to determine copy number changes using CGH probes, to measure allele-specific copy numbers of SNP probes, and to locate regions of LOH/UPD. ]]> <![CDATA[Manipal Health appoints president]]> https://biospectrumindia.com/news/95/5834/manipal-health-appoints-president.html https://biospectrumindia.com/news/95/5834/manipal-health-appoints-president.html Thu, 04 Nov 2010 13:09:00 +0530 Manipal Health Enterprises, one of Asia's largest provider of quaternary healthcare services, has announced the promotion of Dr Nagendra Swamy as President. Dr Swamy's contribution to the organization has been immense. He has been at the forefront-striving to achieve clinical excellence in all healthcare delivery services for the group. His contribution in achieving a quantum jump in revenues in the last five years, is highly laudable. Dr Swamy will be spearheading the brand building and expansion exercise for Manipal Group of Hospitals, across India. Dr Sanjay Goel bags US research award Dr Sanjay Goel, a medical oncologist and researcher at Montefiore Medical Center and Albert Einstein College of Medicine in Bronx, US, adopts an unique approach to his colorectal cancer research. For his efforts, he was awarded American Society of Clinical Oncology Cancer Foundation's Advanced Clinical Research Award. He will receive a three-year award totaling $450,000 to support original research. Dr Goel received the award for his research project titled â€œA novel pharmacogenomic-based therapeutic approach for patients with KRAS mutant metastatic colorectal cancer (mCRC) using an oncolytic reovirus.â€? His research focuses on the anti-cancer activity of reovirus serotype-3 in combination with irinotecan for the treatment of patients with KRAS mutant mCRC. Reovirus, a common community-acquired virus that causes mild flu-like gastrointestinal and respiratory symptoms, can also infect and cause degenerative changes in cancer cells. ]]> <![CDATA[Dupont's GM rice hybrids get GEAC nod for field trials]]> https://biospectrumindia.com/news/95/6035/duponts-gm-rice-hybrids-get-geac-nod-for-field-trials.html https://biospectrumindia.com/news/95/6035/duponts-gm-rice-hybrids-get-geac-nod-for-field-trials.html Thu, 04 Nov 2010 13:05:00 +0530 The Genetic Engineering Appraisal Committee (GEAC) that met on September 29, 2010, permitted confined field trial for event selection on 12 transgenic rice hybrids to Dupont Knowledge Center, Hyderabad. After detailed deliberation, the regulatory body approved the proposal for only experimental event selection trials, during which the applicant will generate detailed information on molecular data on expression for alpha amylase in different tissues; data on segregation of transgenic; and non-transgenic seeds in 1:1 ratio, and a validated seed sorting mechanism for segregating transgenic versus non-transgenic seeds will be developed. The committee gave permission to conduct confined field trial for event selection on transgenic rice events (Hybrid Rice SPT maintainer events) generated using the SPT1 and SPT6 m constructs by Dupont Knowledge Center, Hyderabad. It also allowed the company to conduct event selection trials on transgenic rice events (Hybrid Rice SPT maintainer events) generated using the SPT1 construct. The events generated using SPT1 construct namely; JH 15b, JH 16a, JH 16b, JH 17, JH 25b, JH 26a, JH 36 of BC3 containing ZM-AA1-Os-MSCA1-DsRED2 genes and SPT6 construct namely; J6-1-45a, J6-1-8, J6-1-4d, J6-1-10b, J6-1-7d containing Os-MSCA1-ZM-AA1-DsRED2 genes will be evaluated. The event selection trials will be conducted within the company’s owned land/research farm in Bangalore, with the following reproductive isolation measures are proposed: 200 m isolation distance from the last row of transgenic plant on all four sides will be maintained, with eight feet tall polythene sheets as barriers between each event. During the deliberations, the committee noted the following points: these events were developed by transforming M2O2 X T65 lines and then back-crossed into VIR54G9. All events are single copy events. This technology enables maintenance of male sterile, female parental lines for use in hybrid seed production. The present proposal pertains to hybrid rice seed production technology (SPT). It is a process that facilitates large scale production of non-genetically modified male sterile rice lines that can be used as female inbred parents, for subsequent hybrid seed production. The committee was of the view that the above technology being a relatively a new one, a detailed presentation from the applicant would be useful in understanding the genetic elements of the gene construct, molecular data on expression for alpha amylase in different tissues and data on segregation and sorting of transgenic and non-transgenic rice seeds. The committee further opined that the decision on the next phase of trial (BRL-I) will be based on the data generated by the applicant during event selection trials, and over-all policy on the issue of markers in transgenic plants. Earlier, the Institutional Biosafety committee (IBSC) in its sixth meeting held on July 9, 2010 approved the proposal. The proposal was also recommended by the Review Committee on Genetic Manipulation (RCGM) at its 91st meeting held on July 27, 2010. India to raise 177 crore for OSDD The Open Source Drug Discovery (OSDD) project of Council for Scientific & Industrial Research (CSIR) is set  to receive another financial boost. While pledging support of the government to innovation, Prime Minister of India, Dr Manmohan Singh emphasized that government is committed to raise around `177 crore in funding for OSDD, from international agencies and philanthropists. OSDD facilitates collaboration by providing a platform for mutual sharing of research results, that may be used freely by any participant. The project has already made available the complete sequencing of the Mycobacterium tuberculosis genome. Dr Singh while lauding the efforts of CSIR said, “We believe that institutions like CSIR have to play a catalytic role in this area. Our government is establishing an Academy of Scientific and Innovative Research, that will use the infrastructure of the CSIR to impart cutting-edge research training in frontier areas of science and engineering, that are not ordinarily taught elsewhere. On participation of the private sector in research, Dr Singh said, “If we are to give meaning to our search for new frontiers in Indian science, then a much larger participation of the private sector is also essential. We have to leverage the private sector’s strengths by creating high impact collaborations with public institutions in their translation and transformational efforts. Dr Singh agreed that there is a need to increase the expenditure on S&T, as a proportion of the overall GDP of the country. He also emphasized on the need to address issues related to sharing of intellectual property rights. Indo-German collaboration in life sciences The Council of Scientific & Industrial Research (CSIR), Ministry of Science & Technology (S&T), Government of India, New Delhi, and the International Bureau of the German Federal Ministry of Education and Research (IB/BMBF at DLR), Bonn, Germany, have invited proposals from academia and industry in Germany and India; to collaborate in various areas of science and technology including life sciences. The areas in life sciences covered under the program are biotechnology, genomics,  proteomics, and synthetic biology (possible focus on bioeconomy). The program facilitates bilateral cooperation in the fields of science and engineering between the research institutes of CSIR, India, and those of Germany, by way of joint research projects, bilateral workshops/seminars, exchange visits of scientists and scientific and composite (scientific and industrial) delegations. From the Indian side, scientists working in regular capacity in CSIR research institutes; and from the German side, scientists and faculty members working in regular capacity in public or private R&D institutes can apply under this program. The Indian industrial partner can participate in the program, but the project applicant would be a CSIR scientist only. The Indian company will have to meet its own project implementation cost. The participation of German companies has also been sought, however, financing is limited. The project duration is limited to two years, and expendable by one year. The evaluation and selection criteria includes the relevance to German and Indian national research program and multinational program (like EU-programs). The new projects are in applied fields of mutual benefit, and having justification for collaboration along with quality and originality of research approach. The applications from India and Germany were accepted at the respective offices of CSIR and IB/BMBF till October 31, 2010. The short-listing of selected projects would be completed by January 2011, and the projects will start in April 2011. Strand releases Avadis NGS software Strand Scientific Intelligence, a wholly-owned subsidiary of India’s Strand Life Sciences, has released Avadis NGS, a software application for next-generation sequence analysis. Avadis NGS helps biologists visualize and perform downstream analysis on their NGS data, simply on a desktop computer. Avadis NGS is an application based on ChIP-SEQ, RNA-SEQ and genetic variation analysis that enables its users to assimilate large amounts of NGS data and ascertain deep biological insights using powerful statistics, interactive data visualizations in a state-of-the-art genome browser, and downstream analyses. François Mandeville, executive vice president of Strand Scientific Intelligence, said, “Avadis NGS represents a major milestone in NGS, and finally shifts the power of analysis from information technology and informatics experts to the biologists.” Avadis NGS is built on Strand’s award-winning scientific intelligence platform, Avadis, for data analysis and visualization. The Avadis platform has enabled rapid development of software for life and health sciences applications such as Agilent Technologies’ GeneSpring and powered breakthrough scientific discoveries by seven of the top 10 global pharmaceutical companies. India, Russia to explore pharma, biopharma sectors India and Russia have agreed to explore the possibility of setting up joint ventures in pharma and biopharma sectors, API and therapeutic specific sector in both countries, including joint setting up of R&D/testing facilities. They have also agreed to exchange technical know-how for production of pharma products including bulk drugs, serums, biosimilars and vaccines, participation in setting up of enterprises for scientific and production capacity. This was decided during a meeting between the Indian delegation, led by Mukul Joshi, secretary, Department of Pharmaceuticals, Government of India, and Russian delegation led by Russian Minister for Industry and Trade, Victor B Khristenko on September 29, 2010. Jubilant Organosys is now Jubilant Life Sciences Jubilant Organosys, an integrated pharmaceutical and life sciences company headquartered in New Delhi, has  changed its name to Jubilant Life Sciences. Commenting on the development, Shyam S Bhartia, chairman & managing director said, “Almost a decade ago, we had stepped onto this path of transformation, and today, we have successfully positioned ourselves as a life sciences company, with a presence across the value chain.” With this change, Jubilant Life Sciences becomes the flagship company of pharma and life sciences business of the Jubilant Bhartia Group which also has interests in food and retail, oil and gas and aerospace. ]]> <![CDATA["India offers favorable conditions for clinical research"]]> https://biospectrumindia.com/news/95/2793/india-offers-favorable-conditions-for-clinical-research.html https://biospectrumindia.com/news/95/2793/india-offers-favorable-conditions-for-clinical-research.html Thu, 04 Nov 2010 12:53:00 +0530 —Simon Britton, VP, Clinical Development, Asia Pacific, PPD. Significant work migration from India to China is expected in the coming days In India, PPD has offices at Bangalore, Mumbai and New Delhi. Recently, Simon Britton, Vice President (Clinical Development-Asia Pacific), PPD, on a visit to India and China, in an exclusive interaction with BioSpectrum, spoke about the services PPD provides in India, Indo-China market comparisons, and the growth of the industry. Q What services does PPD provide in India and how is it unique? PPD mainly offers monitoring and project management services in India. We are interested in making India a major part of our operations, but we primarily intend to provide global services. We operate in multiple countries; and have a significant presence in Asia, Eastern Europe and North America. In therapeutics, we focus on many areas and the major segment is oncology. The PPD staff number 11,000. Given the conducive environment and the predictable regulation, there is a lot in terms of service that PPD can provide. Although we are yet to start lab services in India, our clinical research associates (CRAs) are well trained and capable of high quality of work. Q Have there been any issues with availability of volunteers? The infrastructure, manpower, clinical trial accessibility in India are conducive for our business. India has a sizeable population of 1.2 billion. There are really no manpower issues. Q How do you compare markets in India and China? At the moment, there is a significant difference between markets in India and China. India has better quality and English-speaking skills. There is a clear maturity of research and manpower skills. The regulatory environment is predictably good; and the Drug Controller General of India (DCGI) has made considerable efforts to improve it. India is much more in line with countries like the UK and US. India has a significantly better regulatory aspect; and offers a competitive edge over many other countries. India is seen as a quality-provider; and Indian operations are a gateway to the rest of the world. In comparison, China is trying to improve standards on many fronts. One of the problem areas in China has been the time (period) taken for trials. The phase III and IV take a lot of time (close to 15 months). However, China is striving to decrease the time duration; and this can lead to migration of significant work from India to China, in coming days. Besides that, China and Taiwan are investing heavily in the overall biotechnology market. Q What challenges do you face in India? There has been a lot of skepticism about working in India. Despite that, things have started to change now. Personally, I am a huge advocate of India, and the huge market potential it offers. However, there are concerns about Intellectual property (IP) with regard to India. Also, I think due to lack of individual medical records, there have been certain reservations about conducting trials on Indian population. The challenges are there, but PPD as a company, is always ready to advise and provide help in this direction. India has become more predictable in the past couple of years. Clinical trials must see improvement by reducing time, and making it more predictable. PPD conducted audit along with the DCGI; and the audits should be a continuous process. India needs to be more clear on the biosimilar front. Currently, a sizeable number of trials are ongoing, and a 60 percent increase is projected for the future. No doubt, DCGI has played a great role in streamlining things in India. Now, it can add many more resources to make things more predictable and better. We are looking forward to sooner availability of physicians and the permission to conduct trials. Q What kind of growth has the Indian market witnessed so far? India has seen a lot of growth, although a slowdown in the clinical research market is witnessed in recent times. All this happened at a time when politicians were pushing biomarkers for individual patients. The last two years have provided a good base. The recent BioIndia at Hyderabad saw deliberations on IP management, protection and increase in the degree of confidence. If India grows at the same rate, we can expect a similar growth in the clinical research market. With regard to PPD, we are looking for a slow but substantial growth, if not doubling our revenues in coming times. Q What are your views on India's talent pool availability? Did you encounter any issues during recruitment? There is a huge pool of talent available in India. It is easy for us to find personnel with the right attitude, expression and integrity. Clinical research is new to India, as it started moderately in the last 10 years. There are only a few people with experience, but now with time, it is easier to find top talent. So far, we have not witnessed any recruitment-related issues here at PPD. Also a majority of our workforce is into project management and clinical research associates (CRAs). We do not provide back office support or downstream process here, as most of that happens outside India, although we have some HR and finance sections here. At the same time, we may look into expanding; and increasing our workforce in this area too. Q What is the status of the current trials being conducted at PPD? There are a significant number of studies that have been going on. Among those, the number of oncology and cardiovascular studies is larger. Currently, about 70-80 studies are going on. We have our sites at strategic locations, and they provide us with an overall ability for successful trials. For local clients, we also offer to conduct phase I R&D of novel drugs. Q Do you have any partnerships in India? What are your future plans for the Indian market? We are working closely with some site contractors. As of now, we do not have any partners in India, but are not averse to mergers and acquisitions (M&A) in the near future. A unique point that lies with us is that we are a zero-liability company, and we have a liquid balance of $6 billion. That gives us a sense of freedom; that we can add supplementary services, and always be ready to talk to anybody for broadening our horizons. In 2011, we plan to build on what we already have. We would be looking forward to adding more workforce and capacity, including, broadening geographical region. Apart from cities, we plan to locate staff in other sites. Another area of focus would be providing additional facilities — the sites located in the North East will have permanent trainingcourses for investigators and faculty members. Rahul Koul in New Delhi ]]> <![CDATA["India, China, Japan are important"]]> https://biospectrumindia.com/news/95/8220/india-china-japan-are-important.html https://biospectrumindia.com/news/95/8220/india-china-japan-are-important.html Thu, 04 Nov 2010 12:49:00 +0530 —Josef von Rickenbach, Chairman & CEO, PAREXEL International Corporation, US Parexel International Corporation is a leading global biopharmaceutical services organization, providing a broad range of knowledge-based contract research, consulting, and medical communications services to lifesciences industries. It is committed to providing solutions that expedite time-to-market and peak-market penetration. Headquartered in the US, PAREXEL operates from 70 locations in 54 countries around the world, and has approximately 9,720 employees. PAREXEL has recently opened a new office in Nagoya, Japan – it already has two offices one in Tokyo and another in Kobe – to support a growing demand for a broad range of clinical development and regulatory consulting capabilities in the Asia Pacific region. Josef von Rickenbach, chairman of the board & CEO, PAREXEL was in Bangalore (India) and spoke to BioSpectrum about the market trends in CRO space and about the company’s Asia strategy. Excerpts from the interview: Q How will the opening of another office in Japan support the growth of business in APAC? Japan is attractive to our worldwide client base for inclusion in global studies, not only for its market potential but also for its high quality data, advanced technologies, and a large pool of well-trained professionals. The opening of our office in Nagoya builds on our established presence and long-term, ongoing commitment to Japan. It allows us to further assist locally-based clients with regional and global market access opportunities. Our regulatory and clinical experts are supporting what we call ‘Japan plus Asia’ studies, since recent regulatory changes allow for inclusion of non-Japanese data for registration purposes. We are also supporting Japan-based biopharmaceutical companies with simultaneous global clinical studies and provide eClinical solutions, to accelerate the clinical development process. Q PAREXEL has witnessed a growth of 39 percent in Asia. How do you plan to maintain this and grow over it? We have a strong presence in Asia Pacific. We might need to look at opening offices in countries where we already have operations. I could envision that we might need to look at strengthening our presence in India, due to its vast geography. We have a very robust presence in China—with four offices—and also in Hong Kong and Taiwan. We wish to remain an entrepreneurial company, with focus on high quality services to clients, to avoid costly study delays and conduct quality clinical research, worldwide. Q Looking ahead, how does Asia fit into your success story? Asia is where the growth in CRO business is. And it is not a surprise in the changing global economy. Since 1995, with the opening of an office in Japan, with just one person, today, we are operating in all the countries in Asia. Currently, over 2000 people are working for Paraxel in the Asia Pacific region, largely from countries like India, China and Japan. Q What kind of operations do you have in countries like Indonesia, Malaysia, and the Philippines? The markets in these countries are maturing and growing. To meet the needs of the customers, we need to be present in these fast emerging markets. Without going into the exact details, I can say, we provide local activities for clinical operations and global functions to the clients. Q How do you see the competition in the market? Everyone who is keen on working with biopharmaceutical and life sciences industry is our competitor. We take all compaanies, either small or big, local or global, who is keen on having a pie in the CRO industry, seriously and compete with them. Q What are the growth projections for PAREXEL? In the last few years, on an average we have witnessed about 10 percent growth. Some significant successes in the new business has helped the company to grow at double-digit even during the economic slowdown. Narayan Kulkarni ]]> <![CDATA[PPP plays research catalyst]]> https://biospectrumindia.com/news/95/7465/ppp-plays-research-catalyst.html https://biospectrumindia.com/news/95/7465/ppp-plays-research-catalyst.html Thu, 04 Nov 2010 12:42:00 +0530 As public private partnerships (PPP) form the backbone of Indian biotechnology industry - leveraging them further can act as a catalyst to boost the product outcome and commercialization Having crossed the $3 billion mark in 2009-10, the Indian biotechnology industry is prepped to achieve significant growth in the future. For this, the industry is heavily dependent on the country's innovation infrastructure, and on the significant role of Public Private Partnerships. In this regard, Government of India, along with the Department of Science & Technology has launched various initiatives like INSPIRE (Innovation in Science Pursuit for Inspired Research), to attract talent into science. The government is also embarking on a major multi-billion dollar-initiative model to harness India's innovation capability. Fifty percent of this is being funded by public private partnership (PPP). The vision is to catapult the country to one of the top five pharmaceutical innovation hubs by 2020, with one in every 5-to-10 drugs discovered worldwide, coming from India. The Department of Biotechnology (DBT) has fostered PPPs to lay their own infrastructure. Some noteworthy examples of such initiatives are the Biotechnology Industry Partnership Programme (BIPP) and the Small Business Innovation & Research Initiative (SBIRI) - that have been a motivating factor for many small and medium enterprises (SMEs). Says Dr Purnima Sharma, managing director, Biotech Consortium of India, â€œSBIRI has opened new opportunities for innovation in the biotechnology industry. Through this program, many successful examples of R&D and commercialization of products have been witnessed.â€? Further, the Indian Council for Medical Research (ICMR) has actively supported clinical research, through its various initiatives and facilities for microbial containment, pre-clinical toxicology units. The Department of Pharmaceuticals (DoP) has initiated efforts to establish a large animal facility, compliant with good laboratory practices (GLP), through the PPP route. Besides these central government initiatives, various state governments are promoting and providing incentives for the creation of biotech parks. R&D as a driver for PPP In India, R&D retains its position as a key driver of the biotechnology industry's success. Therefore, there is a strong need for public private partnerships for nurturing and catalyzing R&D. To provide an impetus to PPPs, the government has directed considerable efforts, by supporting upstart firms with seed funds, through the New Millennium Indian Technology Leadership Initiative (NMITLI) and Special Drug Development Research Initiatives (SDDRI). This is, specifically, to promote the flow of knowledge from national laboratories and institutes to industry - for the development and commercialization of technology. A total of six biotech parks are operational in various states under the public private partnership, and 10 parks are in different stages of development across the country. "Let private enterprise partner public science and technology institutions in their translation and transformational efforts. Let them join hands with our public institutions, in creating new manufacturing strategies for both strategic and non-strategic applications. Let there be publicly-owned and privately-operated world class R&D facilities.â€? - Dr Manmohan Singh, Prime Minister of India, on participation of private sector in research Focus on commercialization The sharing of ideas, facilitating technology transfer and technical expertise, form an important part of public private partnerships in R&D. The CSIR-led institutes like National Chemical Laboratory (NCL), Pune; Centre for Drug Research Institute (CDRI), Lucknow and Institute of Microbial Technology (IMTECH), Chandigarh - are all at the forefront of the public private partnerships. IMTECH has collaborated with 32 companies including Ranbaxy, Cadila Pharmaceuticals, Lupin and Panacea Biotech for various contract research projects. Recently, CDRI, Lucknow has entered into a contract research collaboration with Bangalore-based Biocon. â€œThere are many success stories related to drug development in CDRI, with pharmaceutical industries in private and public sectors. Out of the 16 new drugs/products developed in India, CDRI alone has a share of 11, which shows our important role,â€? says Dr Rajendra Prasad, head, CDRI. Innovation cannot be successful unless knowledge and information in any R&D project are effectively shared. In this direction, virtual teams provide an environment for flourishing innovation in R&D; and bring about knowledge spillovers within enterprises, bridging time and place; therefore, making them not a choice, but a requirement. The Open Source Drug Discovery (OSDD) project by CSIR has been the biggest initiative in this direction so far. â€œThe PPP remains one of the important needs of current times, and there is a need for the industry to come forward and recognize the potential of Indian scientists and their capabilities in R&D,â€? says Dr Rajesh Gokhale, Director, Institute of Genomics & Integrative Biology (IGIB). A public private partnership can play a vital role in addressing issues during a pandemic; to make sure that innovations in biotechnology reach the masses, when critically needed At the onset of influenza A (H1N1) pandemic, Department of Biotechnology (DBT) took a unique initiative to nurture R&D and innovation in biotechnology industry, under Biotechnology Industry Research Assistance Programme (BIRAP). DBT invited proposals from Indian biotechnology companies for indigenous development of a vaccine against influenza A (H1N1), under the Biotechnology Industry Partnership Programme (BIPP). Of the many applicants, New Delhi-based Panacea Biotec was awarded the financial assistance of 10 crore for the development of a vaccine. The Pandyflu vaccine is all set to be launched soon. Objectives: This grant of financial assistance by Goverment of India, through DBT, is in addition to a 10 crore grant of advance market commitment (AMC) by Ministry of Health & Family Welfare (MoHFW). The grant was given to Panacea Biotec to encourage development, manufacture and supply of Pandyflu - a vaccine of paramount national importance. Success factors: As a result of this partnership, Panacea Biotec will give the world an indigenously produced Pandyflu - its vaccine against the H1N1 virus (swine flu). The company developed the conventional inactivated split virion vaccine using egg-based technology, which is a sure shot path for developing flu vaccine. The company has more than 40 years experience, and well established regulatory pathways to ensure faster production of swine flu vaccine matching international standards, to fulfill the global need. Key Takeaways: The vaccine from Panacea will increase options for the common public, to choose among alternatives available in the market. Panacea Biotec has set up a state-of-the-art BSL2 level manufacturing unit (high-containment facility) with BSL3 practices on its sprawling campus, spread over 75 acres of land at Lalru (Punjab), for manufacturing of Pandyflu vaccine. This facility has an annual capacity to manufacture 45 million doses of the vaccine. Way Forward: This type of PPP initiatives to tackle the issue of national importance, should certainly be repeated several times, so the benefit of biotechnology innovation reaches the common people. â€œI am delighted that the efforts of our scientists have again been recognized by Government of India, by accepting our proposal; and grant of the said assistance for such development.â€? -Mr Soshil Kumar Jain, Chairman, Panacea Biotec â€œThe award of the financial assistance by the government reinforces the commitment to promote innovation and public private partnership.â€? -Mr Sumit Jain, Director Operations & Projects, Panacea Biotec Overcoming barriers Despite all success stories, there are certain outstanding issues that need to be addressed. The streamlining of bureaucracy, bridging of infrastructure and funding gap, regulatory requirements, tax and tariff benefits; and most importantly, knowledge sharing in critical research areas between industry and public institutes - are few issues requiring attention. Bt Brinjal to tackle pesticide bullets The development of Bt Brinjal has been an important achievement for the science community, but what it also stands for, is a harmonious PPP The Bt Brinjal was developed by the Maharashtra Hybrid Seeds Company (Mahyco). The company used a DNA-construct containing the cry1Ac gene, a CaMV 35S promoter, and the selectable marker genes nptII and aad, to transform young cotyledons of brinjal plants. A single copy elite event, named EE-1, was selected and introduced into hybrid brinjal in Mahyco’s breeding program. Mahyco then donated the Bt brinjal technology to Tamil Nadu Agricultural University (TNAU), and University of Agricultural Sciences (UAS), Dharwad. Later, the event EE-1 was back-crossed into open-pollinated brinjal varieties. Objectives: To create insect- and insecticide-free brinjals for the benefit of farmers and consumers in India. Also to foster collaboration between private sector and public institutes, for cooperation in sharing of technological knowledge. Success factors: Bt brinjal was found to be effective against Fruit and Shoot Borer (FSB), with 98 percent insect mortality in Bt brinjal shoots; and 100 percent in fruits, compared to less than 30 percent mortality in non-Bt counterparts. The Multilocation Research Trials (MLRTs) confirmed that Bt brinjal required, on an average, 77 percent less insecticides than non-Bt counterparts, for control of FSB, and 42 percent less, for the control of all insect pests of brinjal. Key Takeaways: The benefits of Bt brinjal, translate to an average increase of 116 percent in marketable fruits over conventional hybrids, and a similar increase over popular open-pollinated varieties (OPVs). Furthermore, the significant decrease in insecticide usage reduced the farmers’ exposure to insecticides, and results, in a substantial decline in pesticide residues in brinjal fruit (yield). The scientists have estimated that Bt brinjal will deliver farmers a net economic benefit ranging from 16, 299 to 19,744 per acre — with national benefits to India exceeding 1700 crore per year. Bt brinjal has enormous potential to benefit both farmers and consumers. The results of the studies submitted to regulatory authorities in India confirm that Bt brinjal offers the opportunity to provide effective control against FSB, and decrease insecticide input by as much as 80 percent. Bt brinjal also yields significantly more marketable fruit (yield) than conventional hybrids and open-pollinated varieties. Way Forward: The development of Bt brinjal, the first biotech-vegetable crop in India, is an appropriate and timely step, because it will further demonstrate the significant benefits that biotechnology offers farmers, consumers and India as a nation. The insect-resistant Bt brinjal hybrids and varieties were developed through close and harmonious cooperation between public and private research institutions. The joint contribution of the two sectors is of critical importance, given that national food security is a strategic issue. The adoption and acceptance of Bt brinjal by farmers and consumers in India, will be a highly significant event, that will enormously benefit the country and the world. One of the main barriers to PPP are apprehensions about the misuse of proprietary material or knowledge, by the collaborators in a partnership. The high transaction costs of operationalization and coordination of partnerships, mutual mistrust and negative perceptions have been major hiccups for the collaborators. The inter-sectoral partnerships have been able to deliver anticipated results in the form of advanced researches, and acceptability by companies worldwide. Future outlook The PPP will play a fundamental role in the advancement of biotechnology in the near future. Therefore, the hurdles coming in the way of partnerships need to be addressed, mutually by industry leaders and heads of public institutes. The sharing of knowledge is a necessity, and more platforms should be built for successful interaction and exchange of information between both sides. However, it goes without saying that it is not only the duty of government agencies to take this forward, but a larger participation of the private sector is also essential. -------------------------------------------------------------------------- Some of the Public Private Partnerships in India S No. Company Public Institutes 1 Serum Institute of India, Pune ■ World Health Organization (WHO) ■ Health Protection Agency (HPA) 2 Panacea Biotec, New Delhi ■ National Institute of Immunology (NII) ■ Jawaharlal Nehru University (JNU) ■ Biotech Consortium of India Ltd (BCIL) ■ National Institute of Health, USA (NIH) 3 Avesthangen ■ National Centre of Biological Sciences (NCBS) ■ University of Agricultural Sciences (UAS) ■ ICRISAT ■ Imperial College, London, UK 4 Shantha Biotechnics, Hyderabad ■ Center for Cell and Molecular Biology (CCMB) ■ Indian Institute of Science (IISc) ■ Bhabha Atomic Research Centre ■ National Institute of Immunology (NII) ■ Institute of Chemical Biology (IICB) ■ Jawahar Lal Nehru University (JNU) 5 Rallis India, Mumbai ■ International Centre for Genetic Engineering and Bioltechnology (ICGEB) ■ Indian Institute of Science (IISc) ■ University of Madurai ■ World Heath Organization 6 Strand Life Sciences, Bangalore ■ Indian Institute of Science (IISc) ■ Council for Scientific and Industrial Research (CSIR) ■ Center for DNA Fingerprinting & Diagnostics (CDFD) 7 Syngene ■ Indian Institute of Science (IISc) ■ Indian Association of Cultivation of Sciences (IACS) 8 Bharat Biotech, Hyderabad ■ Department of Biotechnology (DBT) ■ International Centre for Genetic Engineering and Biotechnology (ICGEB) ■ All India Institute of Medical Sciences (AIIMS) 9 Bangalore Genei ■ Center for Cell and Molecular Biology (CCMB) ■ Indian Council for Agricultural research (ICAR) 10 Monsanto , Bangalore ■ Indian Institute of Science (IISc) ■ The Energy & Resource Institute (TERI) 11 Wockhardt, Mumbai ■ International Centre for Genetic Engineering and Bioltechnology(ICGEB) 12 Biocon, Bangalore ■ Central Drug Research Institute(CDRI) ■ Karolinska Institute, Sweden 13 Life Care Innovations ■ Lucknow Biotech Park ■ Punjab State Technical Council 14 Transgene Biotek ■ Council for Scientific & Industrial Research (CSIR) ■ Indian Universities Rahul Koul in New Delhi ]]> <![CDATA[Indus Biotech focuses on cost-effective drugs]]> https://biospectrumindia.com/news/95/1676/indus-biotech-focuses-on-cost-effective-drugs.html https://biospectrumindia.com/news/95/1676/indus-biotech-focuses-on-cost-effective-drugs.html Thu, 04 Nov 2010 12:10:00 +0530 The company has redefined drug discovery by coming up with a model that is cost-effective, without compromising the quality of drug discovery Founders of Indus Biotech Sunil Bhaskaran Rajan Srinivasan The life sciences industry today faces a paradoxical situation. While on the one hand, there is a growing need for novel drugs across different geographies, specially for diseases like malaria, dengue and Parkinson's disease; on the other hand, companies are going through the most tumultuous period in history, with drug pipelines drying up, due to poor R&D productivity. Adding to the sitaution is the sky rocketing increase of drug discovery costs, presently at over 7,500 crore-a cost that is nearly impossible for small- and mid-sized biotechnology companies. Most importantly, the number of candidates failing phase III clinical trials have been growing by the day. This is, when an innovative drug discovery model that is cost-effective, mitigates risks, yields high return on investments (RoIs) becomes a pre-requisite and Pune-based, Indus Biotech devised one such business model. The company, rather than looking at deriving molecules from synthetic-based compounds, extracts compounds from the plant kingdom, whose safety has already been proven, and which can have physiological effects on living organisms like the human body. The genesis In 1997, Sunil Bhaskaran teamed up with IIT-batch mate, Rajan R Srinivasan (presently Executive Director of Indus Biotech) and (Late) Dr Kris Venkat (who was then on the Supervisory Board of Strand Life Sciences). The trio put on their thinking caps to come up with a model that focused on the discovery of novel molecules for chronic diseases, and at the same time, one that would be cost- effective. Thus germinated the idea to set up a company, Indus Biotech. Recalls Sunil Bhaskaran, managing director, Indus Biotech, â€œDr Venkat believed that many interesting molecules can come in from the plant kingdom. Drug discovery costs at that time were becoming huge. When we started this business, the drug discovery costs were close to 4,000 crore. We then started thinking of finding a model that is cost-effective and requires less capital-to discover drugs for chronic diseases. That was the business thought behind setting up Indus Biotech.â€? â€œOur business model is basically to develop an NCE, and then license it to a Big Pharma but half way through, we will be able to sell some of these productsâ€? -Sunil Bhaskaran, managing director, Indus Biotech The compounds in this case, are extracted from raw materials in the food chain. From here, the company has a three-way approach to keep the revenue streams flowing. The first approach is taking the molecule up to the level of a novel chemical entity (NCE), where it will be further licensed out to a big pharmaceutical company. Half way through the product development, it can be sold as a consumer healthcare product. The third option is to obtain approval from FDA as a Botanical Prescription Drug. â€œThere are always chances that during the course of the discovery and development process, the candidate might exhibit some additional useful physiological effects. So, we have developed an option where we can use it for other applications also. Our business model is basically to develop an NCE, and then license it to a Big Pharma but half way through, we will be able to sell some of these products as consumer health products,â€? adds Bhaskaran. Like all business ventures, the promoters were faced with myriad challenges in the beginning, with funding topping the list. The promoters of Indus Biotech and angel investors together brought in 11-13 crore to the company. Kotak India Private Equity Advisory headed by Nitin Deshmukh invested 31 crore about two-and-a-half years ago. â€œVery few venture capitalists at that time were ready to back a start-up with a fundamentally new business concept like ours,â€? adds Bhaskaran. This apart, the class of drugs Indus Biotech dealt with was often confused with that of Ayurvedic medicines. Says Madhu Kode, Technical Analyst, Indus Biotech, â€œThe biggest task was to make people understand the kind of model we follow. An ayurvedic medicine may constitute many compounds, but we will not be able to pinpoint the active compound within the medicine which will act against the disease. This is not the case for the class of drugs which we deal in.â€? The third challenge was that a regulatory pathway for botanical drugs were not present anywhere in the world except in the US (which came out in 2004). While the European medicines agency (EMEA) is presently still in the process of coming up with guidelines for botanical drugs, India is yet to come out with a regulatory pathway. Unique drug discovery model The distinctiveness of the model is that it starts with in vivo studies at an early stage, that evaluates target activities of the drug, and assesses the failure and side effects of the drug. This drastically reduces the costs of development. Another advantage of the model is that it also looks at early stage proof-of-concept studies that evaluate human safety and efficacy of the drug. Thus, the risk of failure during the later stages of development is mitigated because, before reaching an Investigational New Drug (IND) approval, the safety and efficacy of the drug has already been established. The traditional drug discovery model cost costs about 3500 crore, and takes around six-and-a-half years for the molecule to reach regulatory IND approval. The drug discovery cost within the canvas of the Indus Biotech model is a fraction of 3500 crore - spanning a time period of four years - before it reaches the stage for IND approval. The regulatory pathway for botanical drugs opening up in the US opens up a world of opportunities for Indus Biotech who can further work on drugs with proven therapeutic efficacy. The FDA guidelines permits poly-molecular assays with benign impurity profile, thus further reducing development costs. Indus Biotech is majorly targeting the US market for its consumer healthcare products due to the growing size of segments like the nutraceuticals. This will bring in quick revenues to the company, that can further be used to sustain their research work. The star products The company presently has seven NCEs in its pipeline, focusing on 13 therapeutic areas with the lead molecule being a HIV/AIDS drug candidate, IND02. Last year, this lead candidate got the IND approval from the FDA. IND02 converts a HIV patient into what is called in scientific circles, a â€œHIV Controllerâ€?, and people can well live out their normal life span with the disease - without the concerns of the high cost of treatment, or the dramatic shortening of their life span. IND02 is a drug candidate that is an â€œenablerâ€?, that converts the HIV patient to a HIV Controller. Interestingly, the molecule has also shown new indications for H1N1 strain as well as H3N2 strain (avian flu). Also, it has shown to be effective on Tamiflu-resistant strains. â€œWe have independently verified the studies in Japan and biosafety tests were conducted in the National Taiwan University Hospital in a P3P4 lab,â€? said Bhaskaran. The company has not yet moved forward with clinical trials in the US for this candidate. â€œWe did some additional bioavailability (BA) studies of the candidate in India. We are now ready to start clinical trials in the USâ€?, adds Kode. Other candidates include diabetes (completed proof of concept studies and ready for phase III), rheumatoid arthritis (RA) (completed proof of concept), Parkinson's disease (completed proof of concept, and will move onto human trials), Huntington's disease (preclinical), kidney disease and depression. The company is also looking at other segments like dengue and malaria. The major hitch for the company has been the absence of a regulatory pathway in India for these class of drugs. This, Bhaskaran believes, can cost dear to the company. â€œSince India does not have a regulatory pathway for botanical drugs, the drugs have to be approved in the US, and hence the costs will rise because of the process of the application protocols, and then go through the clinical trials protocol in the US.â€? Post the IND approval by the FDA for IND02, the company also put forward a dossier before the DCGI for IND approval in India. But the dossier was withdrawn due to a lack of guidelines. â€œWe have an active molecule presently, which we believe, will be a solution for dengue. But in India, there is no regulatory pathway for our kind of molecules. We will have to take it to the NCE level and then license it out to the big pharma, which is a prolonged process. On the other hand, dengue as a disease profile has a minor market share, resulting in less interest among the big pharmaceuticals,â€? opines Bhaskaran. Presently, Indus Biotech has 35 patents already granted in different countries; and 25 patents awaiting approval. â€œWe have a total of 60 patents. A patent takes around four years to get approval, and the cost for one patent is about `6 lakh. So, we have invested a lot of money in Intellectual Property (IP) generation,â€? says Bhaskaran. Looking to the future To sustain their business model, Indus Biotech is now actively looking for partners that include both big- and mid-size pharmaceutical companies. Presently, the company is in talks with big pharmaceutical companies for licensing its NCEs, while for consumer healthcare products, Indus Biotech will first tap the US markets, and gradually move to Europe. The company's molecules for RA and Parkinson's disease, are in late stage development, with the Parkinson's one completing human data and proof-of-concept studies. â€œWe also have a study on the side effects of oncology, for which we are creating human data. All our IND approvals, will be filed strategically when some funding is available,â€? says Bhaskaran. The company is also looking at setting up a marketing subsidiary in the US, but not in the near future, as it presently has advisors in the US and in Europe. Nayantara Som in Mumbai ]]> <![CDATA[Booster shot for biosimilar market: Pfizer-Biocon deal]]> https://biospectrumindia.com/news/95/1971/booster-shot-for-biosimilar-market-pfizer-biocon-deal.html https://biospectrumindia.com/news/95/1971/booster-shot-for-biosimilar-market-pfizer-biocon-deal.html Thu, 04 Nov 2010 12:03:00 +0530 The recent Pfizer-Biocon insulin products deal has created waves in the Indian biopharma industry. This deal opens a floodgate of opportunities for Indian biosimilar companies, in providing contract clinical/manufacturing services, and collaborating on other novel products October 18, 2010 saw a major milestone in the global biopharmaceutical industry, with Biocon, Asia's premier biotechnology company, and Pfizer, world's leading biopharmaceutical company, signing a strategic global agreement, under which Pfizer will pay 890 crore ($200 million) for exclusive rights to globally commercialize several of Biocon's insulin products - Recombinant Human Insulin, Glargine, Aspart and Lispro. Biocon is also eligible to receive from Pfizer, an additional payment of about 600 crore ($150 million), towards further development of the drugs, and to meet regulatory milestones. Biocon would also receive payment linked to Pfizer's sales of the insulin products. This deal enables Pfizer to get exclusive rights for commercialization of these products globally - with certain exceptions, including co-exclusive rights for all products with Biocon in Germany, India and Malaysia. Pfizer will also have co-exclusive rights with existing Biocon licensees, with respect to some products, primarily in a number of developing markets. Biocon will remain responsible for clinical development, manufacture and supply of these biosimilar insulin products, as well as for regulatory activities - to secure approval for these products in various geographies. Biocon's recombinant human insulin formulations are approved in 27 countries in developing markets, and commercialized in 23; while Glargine has been launched in India. Commenting on this alliance, Kiran Mazumdar-Shaw, chairman & managing director of Biocon, says, "This, indeed, is a significant inflection point in our globalization path. Pfizer and Biocon together bring a winning combination of marketing, manufacturing and research excellence â€“ that can build a formidable global footprint in diabetes care. Pfizer brings brand strength; besides a vast, unrivaled global marketing network - that will enable Biocon to realize its objective of seeing its insulin portfolio have a worldwide presence." Industry views Reacting to the developments, Dr Rajesh Jain, joint managing director, Panacea Biotec, says, â€œIt is indeed a positive step for the Indian biotechnology industry, as this deal signifies the acknowledgement of Indian biotech companies' research capabilities by multinational companies. In my opinion, it is just the beginning, that will spur the exponential growth of biotechnology space, both in India and globally. Such deals will certainly have a salutary effect on the industry, in general, and companies focusing on biosimilars, in particular. This deal will enable those companies to attract international investment and talent, more easily than before.â€? Commenting on the prospects of the deal, KV Balasubramaniam, managing director, Indian Immunologicals, says, â€œThe deal is definitely a good booster shot for the biopharmaceutical industry in India, leading to more investment in this sector. Since this is a recognition of the growing competencies of the Indian biopharmaceutical industry, more specifically, its research and quality manufacturing capabilities. The companies that have a sound product pipeline and with recognized research capabilities, will benefit from similar deals. MNCs will cherry-pick products from established players in India, and look at sourcing cheaper from India.â€? â€œThe domestic biosimilars market is not expected to see any significant changes due to this deal, given the dynamics of the insulin market in India. On the other side, globally, this deal can be very impactful on the biosimilar industry. So far, only generic pharmaceutical companies have participated in biosimilar markets, and have had limited sales and marketing expertise in selling branded products in the developed market. This was one of the factors responsible for low market penetration of biosimilar, so far. Pfizer's large sales force can help market these branded biosimilars more effectively, and can potentially garner meaningful market share,â€? says KV Subramaniam, president & CEO, Reliance Life Sciences. Outcome of the deal Sujay Shetty, associate director, Pharma Life Sciences Advisory (Corporate Finance), PricewaterhouseCoopers, India says, â€œThe Pfizer-Biocon deal will have a huge positive impact on biopharma companies. At the same time, the deal has created confidence among multinational companies who are keen on working with Indian biotech companies that are building on manufacturing capabilities for future needs. Such deals will help Indian biotechnology companies to monetize assets they are building upon. This deal will open doors for other biosimilar companies as well.â€? KV Anantharaman, principal analyst (healthcare, research and analysis), Datamonitor, India, says, â€œThe Pfizer-Biocon deal crystallizes Pfizer's entry into global biosimilar market, and fortifies the efforts of the Established Products Business Unit, that was created to counter the patent cliff that Pfizer was heading for. Pfizer's Established Products Business Unit, which is currently worth about 44,546 crore ($10 billion), aims to stabilize its current base business, and transform it into a growing business segment, in order to capitalize on the about 2,000,000 crore ($500 billion) opportunity, presented by the global established products market by 2011.â€? "The Pfizer-Biocon deal is a path-breaker in Indian history. It is a deal where an Indian company has developed a marketable product for which only clinical trials need to be done for the highly-regulated market. Also, the deal is amongst two biggest companies with no presence in the insulin segment, till date. It shows the prowess of Indian R&D, showcasing to the world, the capabilities of Indian companies, to develop not only generic medicines but also innovative technology-based products that can be taken to the world," says Dipta Chaudhury, program manager (Pharma & Biotech Practice), South Asia & Middle East, Frost & Sullivan. This deal marks Pfizer's entry into the diabetes segment, which is one of the major growth drivers of the pharmaceutical industry worldwide - given that over 285 million people are afflicted by the disease globally. The recombinant human insulin market represents an estimated 62,000 crore ($14 billion) opportunity; and will allow Pfizer to compete with well established competitors like Novo Nordisk, Eli Lilly and Sanofi-aventis. â€œPfizer can help us to dislodge entrenched MNCs to gain market shareâ€? -Dr Kiran Mazumdar-Shaw, chairman & managing director, Biocon Q How will the global commercialization agreement with Pfizer augment growth for the diabetes product portfolio of Biocon? Pfizer brings huge brand strength to Biocon's insulin portfolio, as well as enormous credibility to our biologics capabilities. We believe that this quality endorsement from Pfizer will help us garner greater market share in global markets, where our products currently have a presence. We also expect our market share in India to increase, by eating into MNC brands. Q What is your expectation in terms of acquiring insulin market share both in India and globally? We expect to see increased market share in India and other markets where our insulin products have a presence. Q Why is the much-talked about oral insulin of Biocon excluded from this agreement? This is a novel program which is distinctly different from biosimilar insulins. Oral Insulin will be licensed as a separate asset. Q Since Biocon has a strong presence in India, what prompted you to agree for a co-exclusive rights deal with Pfizer? Despite being in the market since 2005, we have attained only 10-15 percent market share. We believe that Pfizer can help dislodge entrenched MNCs, to gain market share. Q How will this deal impact Indian biosimilar market and the global insulin market? Quality that is benchmarked with the highest international standards, will become increasingly vital to carve leadership in the biosimilar insulins segment. Biosimilar insulins in the regulated markets of US and Europe will be solely dependent on physician prescriptions, and not substitutable like generic drugs. Pfizer will have the medical infrastructure to effect this, and make a commercial success of this portfolio. Pradeep Kumar in Bangalore ]]> <![CDATA["Our goal is to make flu vaccine easily accessible in India"]]> https://biospectrumindia.com/news/95/1034/our-goal-is-to-make-flu-vaccine-easily-accessible-in-india.html https://biospectrumindia.com/news/95/1034/our-goal-is-to-make-flu-vaccine-easily-accessible-in-india.html Thu, 04 Nov 2010 12:01:00 +0530 -Dr Krishna Ella, chairman & managing director, Bharat Biotech, Hyderabad Dr Krishna Ella, chairman & managing director, Bharat Biotech, talks to BioSpectrum about the advantages of HNVAC and the company's strategy for this product. Q How are you planning to promote HNVAC in India? Bharat Biotech expects the demand for flu vaccines in India to rise, as consumer’s awareness about the disease increases, and concerns about precaution against the flu, than a year ago. HNVAC will be made available in the private market and through government procurement agencies. Q At what price will the product be sold in the market? This vaccine, HNVAC, will be competitively priced as Bharat Biotech is committed to ensuring that pricing does not become a barrier for consumers to access its vaccines. Q How do you see the competition in the swine flu vaccine market? HNVAC is the only flu vaccine to be manufactured in cell culture in the developing world — a highly sterile and controlled manufacturing process, instead of eggs. HNVAC was tested extensively in one of the largest phase I, II and III clinical trials for flu vaccines in India; and has proved safe and well tolerated. The key benefit of our cell culture vaccine is its potential to scale up and produce large quantities quickly as required; it also has a much more sterile and faster production cycle, without the external dependence on eggs, thus enabling quicker response times, in the event of a pandemic. Q How do you look at the market for HNVAC in terms of market share by the end of 2010? We expect government involvement and increasing awareness on the pandemic to drive the growth of H1N1 vaccines market; thus encouraging market players to gain a better understanding of the market dynamics, technological innovations, product pricing, marketing and regulatory framework. The total global market for influenza including 2009 H1N1 according to estimates is likely to be 46,000 crore ($10.4 billion) during the current winter (2009-2010). The addition of adjuvant and shift to cell cultures can stretch the present global production capacity to increase protection for world population. The results of clinical trial with tested 2009 H1N1 vaccines indicate that a single dose may offer protection to over 90 percent of the vaccinated subjects. The global H1N1 influenza vaccine market is expected to show a high compound annual growth rate (CAGR) from 2009 to 2011; but as most of the global population is expected to be immunized by the end of 2011, a more moderate growth is expected in future. The H1N1 vaccines market is classified into intramuscular and intranasal vaccines sub-markets, of which the former holds the major share. Q In the global market, how are you planning to launch HNVAC? HNVAC has been launched in India as it is the first country to approve our vaccine. However, we have significant demand from South East Asian countries and other Asian, African and South American countries. Our focus is to launch and support the product in India, followed by regulatory approvals in South East Asia. In other parts of the world, we would register or launch HNVAC as per the requirement, depending on local demand. Pradeep Kumar in Bangalore ]]> <![CDATA[A first for Bharat, a first for India: Bharat Biotech launches first indigenous cell-culture H1N1 vax]]> https://biospectrumindia.com/news/95/1879/a-first-for-bharat-a-first-for-india-bharat-biotech-launches-first-indigenous-cell-culture-h1n1-vax.html https://biospectrumindia.com/news/95/1879/a-first-for-bharat-a-first-for-india-bharat-biotech-launches-first-indigenous-cell-culture-h1n1-vax.html Thu, 04 Nov 2010 11:57:00 +0530 After H1N1 vaccine launched by companies like Sanofi-aventis, Zydus Cadila and Serum Institute of India, Bharat Biotech gives India the first indigenously developed cell culture H1N1 swine flu vaccine, HNVAC October 2010 saw Bharat Biotech, one of India's leading vaccine company, launch India's first indigenously developed cell culture H1N1 swine flu vaccine by the brand name HNVAC. This is said to be the only flu vaccine to be manufactured in cell culture — a highly sterile and controlled manufacturing process — instead of eggs, in the developing world. The vaccine was developed with approved strains from World Health Organization (WHO) and Centers for Disease Control and Prevention (CDC) Atlanta (US), by the company's scientists at the Genome Valley facility in Hyderabad. HNVAC is Bharat Biotech's superior, clean, safe and controlled mammalian cell culture technology, ahead of several multinational and Indian vaccine companies, which still use eggs for manufacture. The FDA has discouraged the use of egg-based vaccines due to adverse reactions from egg-based proteins, particularly in children. Commenting on the launch, Chairman & Managing Director, Bharat Biotech, Dr Krishna Ella said: “We are pleased to announce the launch of HNVAC to check H1N1 pandemic influenza that can spread rapidly, resulting in a high rate of disease and death. Bharat Biotech is proud to develop and offer this vaccine with the best FDA-recommended cell culture technology for Indian consumers.” A recent study conducted by Indian Ministry of Health & Family Welfare finds that there is no let up in the causalities resulting from H1N1 influenza virus attack. The findings of this study reveal that till September 2010, samples from 177,816 persons have been tested for influenza A H1N1 in government and a few private laboratories across India; and 42,245 (23.7 percent) of them have tested positive. Of the lab-confirmed cases cumulative since May 2009, the casualties stand at 2,316. Ahmedabad-based Indian pharmaceutical major Zydus Cadila was the first phamaceutical company to launch indigenous vaccine against H1N1. Cadila's H1N1 vaccine, Vaxiflu-S was launched by Indian Health & Family Welfare Minister Mr Ghulam Nabi Azad, in June 2010. VaxiFlu-S is an egg-based, inactivated vaccine-based on conventional technology developed by Cadila's researchers at its Vaccine Technology Center (VTC) in Ahmedabad. VTC further plans to develop a wide spectrum of vaccines against bacterial, viral and protozoal infections. The Indian government has been importing H1N1 vaccine from global pharma major Sanofi-aventis. In July 2010, Serum Institute of India (SII), one of India's largest vaccine manufacturers, launched its indigenously developed intra-nasal H1N1 vaccine, Nasovac. SII thus becomes the third manufacturer in the country to market vaccines for swine flu. A live attenuated influenza vaccine (LAIV) Nasovac, is a single-dose vaccine fitted at the top of the syringe, and about 0.25 ml is administered in each nostril, mimicking the path followed by the virus, to enter the body. The vial consists of five doses. Except for pregnant women, any individual above the age of three years can use this intra-nasal vaccine. On the other hand, an injectable vaccine can be administered only to individuals of 18 years and above. SII has also launched an injectable H1N1 vaccine for children below the age of two years. The product is priced at half the price of similar vaccines, marketed by Indian and foreign companies. The price of a single dose of Nasovac costs 160 ($3.42), and is now available at retail outlets across all cities in India. Initially, SII is marketing the product in India, and after receiving the WHO pre-qualification, it intends to market the product in 100 countries. ]]> <![CDATA[India drives biotech innovation]]> https://biospectrumindia.com/news/95/1602/india-drives-biotech-innovation.html https://biospectrumindia.com/news/95/1602/india-drives-biotech-innovation.html Thu, 07 Oct 2010 16:02:00 +0530 The government of India has implemented several funding initiatives to strengthen the growth of biotech sector in the country. All these efforts are aimed at driving innovation in biotech R&D. An overview on major government funding initiatives Several government funding agencies offer different types of research grants, fellowships through soft loans or equity, to conduct research in various fields of biotechnology, and commercialize indigenous biotech products. There are three major departments under the Ministry of Science and Technology, Government of India; each with its own mandate and funding programs. These include the Department of Science and Technology (DST), the Department of Biotechnology (DBT) and the Department of Scientific and Industrial Research (DSIR). Besides that Indian Council for Medical Research (ICMR) and the Council for Scientific and Industrial Research (CSIR) play a major role in the promotion of biotechnology in the country. In 1971, the Government of India set up the DST with the objective of promoting new areas of science and technology; and it plays an important and central role in organizing, coordinating and promoting science and technology in the country. It has many funding programs to foster innovation in R&D in biotechnology. DBT was established in 1986 to give impetus to the development of modern biology and biotechnology in India. Since then, the DBT has actively promoted and accelerated the pace of biotechnology, by providing adequate infrastructure facilities. The DBT is responsible for formulating policy and promoting biotechnology in the country. It has been spending around 1,300 crore a year, to support R&D and innovation. India plans to spend around 700 crore in the next two years, to boost production of biopharmaceutical firms, even as the local industry gears up for a global boom. The government is focusing on developing infrastructure for enhancing drug production, using biotechnology applications. The DBT had alloted 1,000 crore (Plan) and 24 crore (Non-Plan) for fiscal 2009-10, as compared to 865.03 crore in the previous fiscal. This was later revised to 902 crore (Plan) and 23.90 crore (Non-Plan). The budget allocation for 2010-11 is 1,200 crore (Plan) and 22 crore (Non-Plan) Speaking exclusively to BioSpectrum, Dr S Natesh, senior advisor, DBT, says, “About 30 percent of the total funding goes into the public-private partnerships (PPP). So far, 11.78 crore has been spent in the PPP. The DBT will also spend around 42 crore for the creation of Centres of Excellence.” While sharing DBT’s vision of establishing a new breed of institutes to promote the multi-disciplinary approach to education and research, Dr Natesh says, “We are in the learning curve, and have plans to do many exciting things in the days to come. There has been good progress on the work towards the development of the Faridabad Cluster, and the recent establishment of the cluster board, this year. Besides that, the development of Mohali and Bangalore Cluster is also going on, and we can expect many more centres of excellence in the future.” The DBT currently operates three funding schemes—Small Business Innovation Research Initiative (SBIRI), Biotechnology Industry Partnership Program (BIPP) and Biotechnology Industry Research and Assistance Program (BIRAP). In the fiscal year ended March 31, 2010, the grant to all three schemes was 120 crore. Success Stories of SBIRI The SBIRI was launched in 2005 by the DBT to boost public-private partnerships, support high-risk pre-proof-of-concept research and late-stage development in small-and-medium companies, led by innovators with science background, which is unique in nature to support private industries, and to get them involved in the development of such products and processes that have high societal relevance. Commenting on the response to SBIRI, Dr Natesh says, “Since its launch, SBIRI scheme has been well received by the industry. So far, 694 project proposals have been received and there have been 71 successful applicants with this scheme. Also 13 batches have passed under this excellent scheme, and currently the application process is on for the 14th batch.” A large number of products with great commercial value came out from various SBIRI projects. At the moment, there are six new products or technologies under consideration. The DSIR has a wide mandate to encompass the support of project, which promote trade in technologies, showcase Indian R&D and technology capabilities in the country or abroad; to promote collaborative R&D and technology development projects. The Technology Development Board (TDB), created in 1996, manages the fund for technology development and application. TDB invests in equity capital or gives soft loans as per the requirement of the industries, cooperatives and other agencies, which are involved in the development and commercial application of indigenous technology, or adapting imported technology to wider domestic applications. Technology Information Forecasting and Assessment Council (TIFAC) is an autonomous organization under the DST, with an aim to keep a technology watch on global trends, formulate preferred technology options for India, promote key technologies and provide information on technologies. Falling under the ambit of TIFAC, the home-grown technology program, aims to give financial, techno-managerial and patent-related support to deserving technology development projects, for pilot operations and/or significant improvement to existing ones. The Program aimed at Technological Self- Reliance (PATSER) is supporting industry for technology absorption, development and demonstration. PATSER also helps to enhance indigenous capabilities for the development and commercialization of contemporary products and processes of high impact. PATSER attracts the involvement of national research organizations in joint projects with the industry. Technopreneur Promotion Program (TePP) is jointly operated by DSIR and DST. It has the mandate of  tapping  the existing innovative potentials of Indian entrepreneurs, to assist innovators to become technology-savvy; and to assist in networking and forging links for the commercialization of their developments. Scheme to Enhance the Efficacy of Transfer of Technology (SEETOT) supports technology acquisition and management. The National Register of Foreign Collaborations (NRFC) has a major objective to facilitate acquisition and management of technology in the country more efficiently. Transfer and Trading in Technology (TATT) is catalyzing technology-intensive export efforts of industry/R&D through grants and technical assistance. The Indian Council for Medical research (ICMR), one of the oldest medical research bodies in the world, has been involved in the funding of projects in formulation, coordination and promotion of biomedical research. The ICMR is funded by the Government of India through the Department of Health Research (DHR), Ministry of Health and Family Welfare. ICMR promotes biomedical research in the country through intramural, as well as extramural research. Dr VM Katoch, director general, ICMR, says, “During the Tenth Five Year Plan period, ICMR gave priority to develop infrastructure for conducting fundamental and strategic research. This has resulted in the conduct of research, which has provided encouraging leads for development of new products.” “In the Eleventh Five Year Plan period, efforts are being made to pursue the leads for product development. The list of programs which have the potential to translate into the national healthcare program or clinical practice, were obtained from the directors of institutes. From this list, 53 top priority technologies/programs out of 103, were identified, and short-listed to carry forward on a priority basis, so that the technologies so developed could be utilized into the healthcare system at the earliest,” adds Dr Katoch. Considered as the novel initiative, the Open Source Drug Discovery (OSDD) program, introduced by the Government of India, is a CSIR-led team India consortium with global partnerships. OSDD focuses on discovering drugs for tuberculosis, and making them available to patients at an affordable cost, through collaborative research involving scientists, medical professionals, researchers, students and others who can meaningfully contribute to drug discovery. Another initiative from the CSIR, the New Millennium Indian Technology Leadership Initiative (NMITLI) was formed to facilitate grant allotment for public institutions, and soft loans for private sector companies. Small, medium and large scale companies involved in R&D; and public institutes are eligible for the grant amount under NMITLI. The government’s initiatives to support the emerging biotechnology industry through different programs, schemes and projects under different agencies, will  go long way in meeting the immediate funding needs of the companies. Tax incentives from government Besides the regular funding, the Government of India provides rebates in customs, central excise, service tax and income tax to steer the growth of the biotechnology industry. Rebates include concessional rate of five percent customs duty and zero countervailing duty (CVD) provided on import of specified items, by public-funded R&D institutes. There is an exemption from excise duty, subject to conditions, extended to specific items, when domestically procured, for the purpose of research by institutions registered with the DSIR. Also, the water purification equipment working on the membrane-based technologies developed by institutes and organizations under DSIR, have been fully-exempted from excise duty. The service tax of 12.24 percent has been exempted on clinical research services. This includes new drugs, vaccines and herbal medicines. Among the income tax rebates, weighted deduction of 150 percent was sanctioned for expenditure related to in-house R&D until March 31, 2012. Also, there is an exemption for certain incomes of a venture capital company, specified businesses or industries engaged in the business of nanotechnology, biofuels and all the areas of biotechnology. DoP to create VC fund In an attempt to push research in pharmaceutical sector, the Department of Pharmaceuticals (DoP)  is planning to set up a 10,000 crore venture capital (VC) fund, to provide the much-needed financial assistance to the players. The DoP will contribute 15 percent under a public-private partnership model, and the rest would be raised from other interested investors. The funds would be raised in three phases 3,000 crore in fiscal 2011-12; 5,000 crore by 2013 and 2,000 crore by 2015. The complete fund will get utilized by 2015. The plan is to provide financing for new drug discovery projects and for biopharmaceutical products in the country. Rahul Koul in New Delhi ]]> <![CDATA["Not having funds in place has not impacted us"]]> https://biospectrumindia.com/news/95/2418/not-having-funds-in-place-has-not-impacted-us.html https://biospectrumindia.com/news/95/2418/not-having-funds-in-place-has-not-impacted-us.html Thu, 07 Oct 2010 16:00:00 +0530 – Tania Fernandez, director, Burrill & Company, India In a free-wheeling conversation with BioSpectrum, Tania Fernandez, director, India, Burrill & Company, throws light on the reasons for the firm not finding the right partner in India till date, the challenges that overseas investment firms face in India; and Burill & Co’s strategy for India. Q What is the fund allocation by Burill & Co for life sciences sector in India? We do not have a set allocation for investments in the life sciences space in India. Burrill & Co is a global firm, and we have a large footprint, in both developed and emerging economies. We invest where the best opportunities present themselves; and therefore, do not like to limit ourselves by predetermining allocations to a country. Our deal flow is global. Burrill has been eyeing India for a long time now, and we have studied the life sciences landscape very intensely and carefully. We are still looking for the right partner in India, for our Burrill India Healthcare Fund. When that fund is up and running, the fund worth `690-`920 crore ($150-$200 million) will be allocated to India. Not having that fund in place, however, has not impacted us, since we have continued to analyze the investment opportunities that the Indian life sciences industry offers; and will continue to invest in the region from our global funds. In terms of a portfolio, our domain expertise is in the life sciences sector; and we have applied the same model for all the regions we operate in. In India, it will be no different. Life sciences, pharmaceutical, biotechnology, healthcare and healthcare delivery, remain areas of top priority for us. Q What are the challenges faced by life sciences industry in terms of financing and funding their initiatives? The Indian venture capital (VC) industry has adopted a late-stage/private equity (PE) investment model. Just take a snapshot of deals that are being done today, or over the past two-three years. They can, with some exceptions, be characterized in the same buckets: generics, CRAMS offerings, pharmaceutical and hospital deals. So, recognizing that next wave is important for sustainability of the Indian life sciences industry, it is important that we are able to groom our Indian life sciences companies. If not, we fall into the risk of saturating ourselves with the shortsightedness of vision, and capitalizing on the present exuberance, without building for the future, and a time may come when we will be unpleasantly surprised. I think entrepreneurs fall into a trap of taking whatever capital is available. The life sciences industry is a very regulated industry. There are a couple of great mid-tier companies that I have met with, that have the potential to enter regulated markets. It takes more than capital though, it takes having the right VCs around your table, putting the right boards together, making sure you have the right networks, building a business plan that is well thought of with long term vision. The lack of early stage VC funds (and I would go even further to say VC funds in general) is disheartening. There is no ecosystem that exists today, where you can take a technology out of a university, form a company around it; and then bring to the management team the kind of expertise, that is required at each level of company maturation, right to the point of exit. We, at Burrill, have fought that culture very hard, and strongly advise entrepreneurs to spend more time with their investors flushing out business plans. If all you are thinking about is dilution, when you are raising funds, then the outcome is evident. Q Do you see a change in the mindset among financial firms towards the biotech industry? Yes, and I have commented on this earlier. There are also very few formal angel networks, unlike in the US. I also do not believe the situation will change, unless something is done at the government level. I do give the Indian government credit for a number of initiatives that they have put in place; but to exploit its full potential, public-private partnerships may well be a solution. There is progress, and one must always commend that progress. There is a change in the mindset towards funding of the biotechnology industry, but, I don’t think the change has been enough to rectify the fundamentals that need to be changed. Q There have been many overseas firms looking at investing in India. However, nothing concrete has happened. What do you think are the reasons? Everyone has a different metric of success. To say nothing concrete has happened may not be true. India is challenging for the many reasons, but Burill & Co continues to bet on India. It remains a region of high priority for the firm. We are very big on cross-border (US-India) and technology infusion. This is why, for example, we do not participate in hospital deals. Our strength and our belief lies in the fact that it is technology infusion and global business models that will drive the next breed of companies. Our first cross-border investment “Bioimagene”, while domiciled in the US, had started off, having India as an integral component, exited within two years of investment. We would like to carve a very unique niche in India—a fund that will invest in companies that have India as an integral component of their business strategy; and Indian companies that are seeking to build global business models. We want to be careful in our investments. Over valued companies, lack of realism in business plans, inability to focus on getting the right kind of capital and  sometimes even lack of transparency have hampered direct investments. Q Are strategic alliances and joint ventures with big-sized companies the more feasible model for getting funds? What are the other models, companies should explore? The management of the company needs to focus on getting the right capital. If strategic alliance and joint ventures are the way to go, then companies should be encouraged to take that route. The questions management need to ask themselves are: “Are we building a stand-alone company, or a company whose business model is built on a partnership model?” “Are we going to build a company that is going to dominate the Indian/APAC/emerging markets, or will this be a company that can enter regulated market?” Key questions like these will help management, to search for the right source of capital. Companies cannot bootstrap themselves to an exit. I think, a lot of investors also come in with the mentality, not that they will take a company right to the exit, but that at some point, they will sell to another investor. This seems to be a favored mode of exit in India. While understandable, since companies take so long to exit, having a dedicated set of investors that will groom the company from start to finish, is what is required. My favorite story, when we were discussing capital in India, and Steve asked me who my competition was, in terms of being able to procure a proprietary deal, I had to tell him it was actually a real estate developer. Without naming the company, here was an excellent technology in India that needed to be groomed and nurtured with the right investors. Very young blood, fresh into the company, decided it was better to take money from a real estate developer rather than going through the process of extreme due diligence. A year from that raise, the gentleman was back with none of the raise having gone to getting to a value inflexion point. Grooming life sciences companies requires a lot of discipline, and a lot of rigor. There sure is no easy way out. And if you are in it, it is a grind from start to finish; but the journey made with the right team, is a journey to remember. Nayantara Som in Mumbai ]]> <![CDATA[India steps closer to personalized medicine]]> https://biospectrumindia.com/news/95/1060/india-steps-closer-to-personalized-medicine.html https://biospectrumindia.com/news/95/1060/india-steps-closer-to-personalized-medicine.html Thu, 07 Oct 2010 14:40:00 +0530 As the knowledge of genetics and genomics rapidly expand, a personalized approach to health care is becoming increasingly important. India is fast becoming a promising contender in the global healthcare arena The majority of the global healthcare industry is ready to offer solutions for the masses. The rapidly advancing field of pharmacogenomics enables diagnostics and subsequent treatment to be 'tailor-made' for each individual, taking into account their genetic makeup. The current healthcare scenario is distinctly more of 'trial-and-error'; which subjects the patients and their physicians to a larger uncertainty of outcome. In the patient's case it often entails greater cost - both physical and financial. The lessons from several spectacular drug withdrawals including Fen-phen, Rezulin and Baycol have improved the ways to test prospective drugs, for toxicity. The role of customized therapy is becoming more important in healthcare and diagnostic industry. Pharmacogenomics redefines the way drugs are developed, and the way in which drugs are chosen for patients; based on their individual genetic make-up. Understanding the underlying genetics behind a patient's response to therapy, is said to allow therapeutic companies develop safer and more effective drugs. In addition, understanding how individuals are genetically predisposed to risk of disease, may result in new drug targets, thereby leading to new classes of drugs designed to delay, or prevent disease onset. Pharmacogenomics in India The existence of a large and diverse population, coupled with a high incidence of genetic disorders makes India, an ideal setting for pharmacogenomics research. Growing interest in individualized therapy to improve drug efficacy has attracted huge investments in pharmacogenomics research. India's growing capabilities in research, clinical development and bio-manufacturing, give it a decisive edge in the development of personalized medicine. An offshoot of personalized medicine is the emergence of new age diagnostics, based on genetic and protein markers, as well as other metabolite-based bio-markers. Today's diagnostic techniques track disease progression, drug response; and are designed to customize therapy in a differentiated manner. Many pharmaceutical companies have made significant investments in pharmacogenomics, with the expectation that it will help to eliminate the unpredictable nature of drug development, bring new products to market, aimed at preventing common diseases, and create premium pricing for their products. It is estimated that by using pharmacogenomics-enhanced drugs and diagnostics, pharmaceutical companies could benefit up to 903-2,258 crore ($200-$500 million) in extra revenue for each drug. Indian scientists are eagerly undertaking pharmacogenomic studies, and many companies are also shifting their focus towards this field. The notable players include Avesthagen, OncQuest Laboratories, Acton Biotech, TCG Life Sciences, Advinus Therapeutics and Jubilant Biosys. Currently, Mumbai-based diagnostic company Acton Biotech, offers pharmacogenomics tests, to identify effective treatment for chemotherapy patients who can benefit from anti-cancer drugs like Cetuximab, Gefitinib, 5 Fluorouracil, Capecitabine, Tamoxifen, Cisplatin and Oxaliplatin. This test makes sure that patients recover effectively. Acton has tested 2,000 cancer samples for 30 genes and 10 drugs. The company is currently working on cardio-pharmacogenomics drug section; and plans to increase its range of pharmacogenomic test as the market grows. Oncquest Laboratories, another important company in pharmacogenomics field brought to the market, Imatinib Resistance Mutation Analysis (IRMA) for chronic myeloid leukemia (CML). â€œThe success of IRMA has been resounding. Many of the prescribing physicians are showing confidence and acceptance of our experience with the assay; and have hence, helped many patients get appropriate therapy for their disease,â€? says Aditya C Burman, managing director of Oncquest Laboratories, New Delhi. â€œThe many years of Oncquest's experience in the field of molecular diagnostics in oncology, has allowed the company to foray into pharmacogenomics, several years ago. With the launch of IRMA, the company has an in-depth look at the potential of the pharmacogenomics market in India,â€? adds Burman. The company has subsequently launched several pharmacogenetic tests including Irinotecan toxicity, Warfarin dosing, Clopidogrel dosing, and have many more in the pipeline. Oncquest is currently working with several companies in this area, and sees many avenues for collaborative work in the future. Burman believes that pharmacogenomics is the future of medicine; and India, which is fast becoming a serious contender in the global healthcare arena, could well be at the epicentre of future breakthroughs. Apart from private companies, public research institutions too, are actively involved in pharmacogenomic research. The Department of Biotechnology (DBT) has been receiving many proposals for funding such studies. The recent completion of the first-ever human genome sequencing as part of Human Genome (HUGO) project in India, by scientists at the Institute of Genomics and Integrative Biology (IGIB), New Delhi, is being seen as a step closer towards personalized medicine. The Council of Scientific and Industrial Research (CSIR)-led Indian Genome Variation (IGV) project, studied 1,000 biomedically important and pharmaco-genetically relevant genes, in populations representing the genetic spectrum of India. The IGV database has information on over 1,000 genes which are involved in diseases such as asthma, diabetes, neuropsychiatric disorders, cancer, coronary artery disease, clotting disorders, high altitude disorders, retinitis pigmentosa, predisposition to malaria and other infections. A team of researchers at IGIB is studying the pharmacogenomics of anti-psychotics, anti-depressant and anti-epileptic drugs, including their pharmacokinetics and pharmacodynamics. The functional consequence of genetic polymorphisms involved in drug response is also being studied by the IGIB team. Another CSIR-led institute, Center for Drug and Research Institute (CDRI) has been leading the pharmacogenomics studies in various areas of research, including the cancer biology. The Indian Council of Medical Research (ICMR) has recently set up a new task force on pharmocogenomics to focus on specific research topics in the field of pharmacogenomics. The task force will focus on various topics of research, including identification of genes and pathways involved in pharmacokinetics and pharmacodynamics of common drugs, and validation of human single nucleotide polymorphisms (SNP) haplotypes of short-listed genes in Indian population. The task force is also intending to conduct research on the development of an 'Indian pharmacogenomics chip'. The ICMR center in Puducherry, an Advanced Center for Pharmacogenomics at the Department of Pharmacology in Jawaharlal Institute of PostGraduate Medical Research (JIPMER) is doing research in this field, and a team of researchers are studying the influence of genetic variation on drug response in patients. Challenges ahead The majority of pharmocogenomic work being conducted in India and globally, are very basic in nature; and so are the end results. Yet, this lays a foundation for many future revelations to come. Burman adds, â€œPharmacogenomics is a combination of various scientific disciplines that gives a clear picture of individual and general population trends. Such a deep understanding of any subject would throw light on problems its practitioners face; and that holds true for healthcare as well.â€? â€œAs more work is done in pharmacogenomics, the industry is able to introduce newer and better pharmaceuticals and companion diagnostic products. The governing bodies have acknowledged the utility of such products; and have, in many cases, guided industry to follow this path in specific instances. Globally, the pharmacogenomics-driven diagnostics and therapies have gained acceptance at a much faster rate, than its predecessors,â€? says Burman. Aravind K Tripathi, senior researcher, Cancer Profiling & Pharmacogenomics Division, Acton Biotech, says, â€œThe field of pharmacogenomics is not immature, and it involves complex processes. Complexity in finding gene variations that affect drug response is tough, because of our limited knowledge of single nucleotide polymorphisms (SNPs). Finding the variations that occur when a single nucleotide in the genome sequence is altered, is more complex, when the three-billion-base human genome can give the possibility of finding such SNPs in millions, which plays a direct role in drug response.â€? Tripathi, however, agrees that the field of pharmacogenomics has not gained enough popularity. He attributes it to the lack of exposure of molecular biology among doctors; high costs of these tests compared to cost of treatment; longer turnaround times and lack of bedside technologies; lack of skilled manpower and smaller market size; and hence lack of investment in marketing these tests. Introducing multiple pharmacogenomics products to treat the same condition for different population subsets, is undoubtedly, a complicated process, in terms of prescribing and dispensing drugs. Apart from these, inherent problems regarding the time and cost associated with the development of diagnostic tests, remain a major restraint for market growth. Moreover, obtaining intellectual property for pharmacogenomic tests pose significant challenges for companies. Therefore, it is essential that the Indian governments' patent systems offer protection for innovations related to personalized medicine. Among different countries, the European pharmacogenomics market is the largest revenue generator, primarily due to the high level of awareness about pharmacogenomics among medical professionals as well as the public. Following the European market is the US, which has radically changed the emphasis on disease management uniformity; focusing more on individual patient management and personalized medicine. Burman of OncQuest believes that there are two main driving factors for this industry. The first is the aforementioned R&D being conducted by pharmaceutical and molecular diagnostic companies. He says, â€œThis is imperative to set the groundwork for a robust pipeline of products that will target several disease segments. In addition to this, efforts need to be given to reducing costs for such tests and treatments, without which it would remain out of the majority of the global population.â€? The second, and perhaps the most important driver, he mentions, is educating the healthcare providers to the proper use of these products; and to facilitate them in formulating appropriate treatment plans for their patients. Without the explicit involvement of treating physicians, these products would stay primarily in the research laboratories, and would rarely make it to the mainstream. Sandeep Saxena, founder & CEO of Acton Biotech, Mumbai, says, â€œThe driving forces for the Indian pharmacogenomics market will be the development of cost-effective and rapid methods, equipment, and kits for the diagnostic tests. With prices coming down, pharmacogenomic tests will find a larger market, and hence attract investments. Significant investments are needed in educating doctors about the basics of molecular biology, clinical significance of these tests; and publish papers relating to drug response and Indian patient genetics.â€? According to Sandeep Saxena, extending partnerships with pharmaceutical companies, medical device companies, large hospital chains and teaching hospitals is vital for growing pharmacogenomics market in India. Jahanara Parveen (with inputs from Rahul Koul) ]]> <![CDATA[Lonza's first ever biosciences hub in India to be set up in Hyderabad]]> https://biospectrumindia.com/news/95/1897/lonzas-first-ever-biosciences-hub-in-india-to-be-set-up-in-hyderabad.html https://biospectrumindia.com/news/95/1897/lonzas-first-ever-biosciences-hub-in-india-to-be-set-up-in-hyderabad.html Thu, 07 Oct 2010 14:30:00 +0530 —Stefan Borgas, CEO, Lonza, Switzerland Switzerland-based life sciences-driven custom manufacturer of active ingredients, intermediates, active pharmaceutical ingredients (APIs) and biopharmaceuticals is strengthening its biosciences base in India, with the construction of its first ever biosciences hub in the country. In an exclusive interview with BioSpectrum, Stefan Borgas, CEO, Lonza, Switzerland, shares more insights into Lonza’s business strategy for India and the global market. Q What are the key growth areas for Lonza? Lonza has three focus areas as part of its core business strategy. Our prime focus is on life sciences manufacturing and R&D; secondly, we do this with the help of high-end chemical and biological technologies; and finally, we execute this with technology excellence. Lonza promotes each of these growth drivers with specialized partnerships. In terms of technology development (R&D), we are looking at emerging regions, where the life sciences market is flourishing. India is, of course, one of the major countries in our focus. Q Lonza has been focusing on extending its collaborations with global companies on emerging sectors. To what extent will it help Lonza’s growth? Our acquisition of Vivante, a US-based custom manufacturing organization, dedicated to producing good manufacturing practice (GMP) viral-based therapeutics, is mainly for technology, to equip Lonza to get closer to the viral vaccine and vector manufacturing. With this acquisition, Lonza can offer the production of viral vaccines. This is very complimentary or significant to our vaccine and technology portfolios. Vivante’s acquisition will also influence cell therapy, where the above-mentioned technologies are needed. Collaboration with GSK, a global pharmaceutical, biologics, vaccines and consumer healthcare company, is mainly for strengthening the customer supply chain. And the strategic partnership with Teva Pharmaceutical, an Israel-based generic pharmaceutical company, provides us the business opportunity to develop selective biosimilars. Q What are the major countries of focus for Lonza in the APAC region? In APAC, we are concentrating on China, India and Singapore. We have a CRAMS unit is Singapore; and a significant presence in China besides a reasonable presence in India. In China, we have developed our nutrition business; and in the recent years, also developed our API manufacturing platform; in the last two years, we have also started the hygiene business. We just started to extend our presence in India. We are concentrating on biology research and markets in biopharmaceuticals and hygiene. India is altogether a different platform for us. In India, we are investing more in R&D in biology. We are seeking more joint ventures, partnerships and collaborations from India. We are very dynamic in India. Q What are the major initiatives taken by Lonza to drive growth in biosciences sector? Growth in biosciences comes mainly due to two factors: the research environment in life sciences market is growing rapidly, that is why we participate in this market; and second growth driver is the technology, a lot more discoveries are happening; so a lot of new products will hit the market, that in turn, steers growth. In Asia, our operations in biosciences are still very small; but we are focusing on high-end technologies that are gaining significance in Asia. In a major initiative, we are constructing our biosciences hub for Asia in Hyderabad. The hub will function as a significant research and production center. The center will be ready by 2012. We have already established labs in the region. We will complete hiring 120 scientists by 2012, for this high-tech facility. Q How will the new biosciences hub influence the growth of Lonza? It will be a niche research hub. We have initiated a number of partnerships for developing and manufacturing products, and exclusive technology transfer. The hub will help us to develop high-tech tools and products for the Indian market. Rather than being a local lab center, it will play an influential role in Lonza’s bioscience research with a wider global focus. This hub will be the first-of-its-kind with novel technology platforms. Some of the initiatives taken will pioneer the global biosciences market as well. Q How is the APAC region faring in biosciences sector? It is very much dependent on the countries. I believe that, India is focusing a lot on the volume game, by providing large quantities of relatively simple pharmaceuticals to its local market, and also to other markets around the world. Apart from this, China gives emphasis to innovation. The peak technology is driven more by Japan; and Singapore also plays a vital role. In the 150-year history of peak innovation, today, Asia along with the US, is at the leading position. Q How is Lonza's growth in  custom manufacturing and life sciences? In custom manufacturing, the growth is just over 10 percent. The current portfolio of the company is small, yet we expect over-proportionate growth, through collaborations and partnerships in the area of biosciences. Q What is Lonza looking at in the next five years in terms of revenue growth and expansion? Now, Lonza is capable of churning out 16,409-17,321 crore (CHF 360-CHF 380 million) profit before tax. In the next three years, we can add between 7,749-11,851 crore (CHF 170-CHF 260 million) from the global market, with the project we have already started. This is really a competitive growth. We will also look at other countries in the bric (Brazil, Russia, India and China) club. “India is a major country of focus for Lonza” —Dr Harry S Rathore, managing director & country head, Lonza India, Mumbai Q What prompted Lonza to develop the biosciences hub in India? We found R&D activities are exponentially increasing in India. We want to be a part of this success story. As India has scientific talent pool and Lonza has established its presence in the Western markets; we wanted to bring our experience and expertise to Indian market. This made us to select India as our biosciences hub. Q How much investment is allotted for establishing this hub? Investments will be made in phases. The first phase investment will be some where around (not including the land) 44.30-66.50 crore ($10-$15 million). That is just for phase I, and our blueprint is much longer. At this time, I cannot even guess the investments of phase II and phase III. Q How is the business scenario in India and how is it helping Lonza? India is one of the major countries of our focus. We are concentrating on our areas of competence. A lot of research activities are going on and we are providing the tools for life sciences research in India. We have sales and commercial office in Mumbai. We have biology or cell biology R&D activities in Bangalore and we are building our knowledge center at Genome Valley in Hyderabad. The knowledge center will function as a major global R&D think tank for Lonza’s biosciences activities. Pradeep Kumar in Bangalore ]]> <![CDATA["THSTI focus is on product outcome and not publications"]]> https://biospectrumindia.com/news/95/3968/thsti-focus-is-on-product-outcome-and-not-publications.html https://biospectrumindia.com/news/95/3968/thsti-focus-is-on-product-outcome-and-not-publications.html Thu, 07 Oct 2010 13:29:00 +0530 —Dr Sudhanshu Vrati, Dean, Translational Health Science & Technology Institute (THSTI), Gurgaon Translational Research is headed to be the space grabbing spotlight next; and is receiving impetus in the country. The Translational Health Science & Technology Institute (THSTI) is an institute that initiates steps in this direction.   THSTI will function from a unique Health Biotech Science Cluster (HBSC) in Faridabad (Uttar Pradesh), being developed by the Department of Biotechnology (DBT), Government of  India. Currently located at Udyog Vihar, Gurgaon (Haryana), THSTI will move in the next couple of years to the 200-acre HBSC campus. HBSC will foster innovative conceptual research in a wide range of biotechnology-related sciences, with initial focus on health biotechnology. A senior scientist at National Institute of Immunology (NII), New Delhi, and actively involved with THSTI since 2005, Dr Sudhanshu Vrati, recently joined THSTI as its Dean. In an exclusive interaction with BioSpectrum, Dr Vrati, talked about the history, mandate and current activities of THSTI. He also shares his opinion on the progress of biotechnology industry in the country. Excerpts: Q Can you elaborate on the idea and history behind THSTI? The initiative was taken as the existing institutes in India do not have adequate infrastructure to conduct translational research, and lack the know-how and expertise, to promote it. I congratulate Dr MK Bhan, secretary, DBT, for initiating this process. He has been working on rotavirus and knows the difficulties of transferring from the laboratory to the industry. That is how THSTI was initiated in 2005, but the funding was approved only in 2007. Until recently, THSTI was operating at the facility of the NII, New Delhi. The interim laboratories were unveiled by Prof G Padmanaban, distinguished biotechnologist, at Udyog Vihar, Gurgaon on March 29, 2010. “In a couple of years, we will be moving to the main campus in the Biocluster located at Faridabad, where currently construction is in progress. Q What is the structure and mandate of THSTI? Essentially THSTI is made of three components – the first being, Vaccine & Infectious Disease Research Centre (VIDRC) involved in research in relevant areas of immunology, virology, microbiology, structural, chemical and systems biology. Research areas in host-pathogen interactions, covering the entire range of expertise and interest; from statistical and epidemiological, to the cellular and molecular levels will be considered. The  second component is the Pediatric Biology Center. Besides this, there will be a Center for Biodesign that will focus on bio-devices and diagnostics. THSTI will serve as an umbrella organization for all these centers, by the support of the Faridabad Biocluster. Besides THSTI, the Biocluster will house the UNESCO Regional Center for Biotechnology (URCB). The mandate of THSTI will be to conduct innovative translational research and develop research collaborations across disciplines and professions; to accelerate the development of concepts into tangible products to improve human health. Q What is the current focus of THSTI? Our focus primarily is on doing fundamental work, recruiting competent people and developing quality labs. Besides higher research, the courses to be taught at THSTI would include a postgraduate course in Translational Health Science.   Currently, we have recruited three assistant professors and one professor, and three more are on the list. We plan to have at least 10 faculty members by next year. Of the 200 applications received, only three candidates were selected. The idea is to go slow, and get the best talent available. Our focus currently is on quality manpower, capacity building and infrastructure. Besides that, we are focusing on having our own dedicated faculty leaders, members and lab space. The center would develop its own process. Our research at present, is focused on contaminated water, which is the top concern in the country. Viruses such as dengue and malaria are our main focus. We are also working on a tuberculosis (TB) vaccine. Recently, a website for THSTI has been made functional, and enhancements are being made, to increase interactivity. Q What kind of collaboration would you be interested in, with the industry? Do you feel the need for change in curriculum? I feel we have to work hand-in-hand with the industry. We have been working with Bharat Biotech on rotavirus vaccine development, which is currently in phase III trials. Also, we are focusing on the most prevalent viral diseases in India such as dengue and malaria. We are trying to boost our manpower by recruiting people with the right expertise, committed to product outcome, so that the industry does not feel let down while approaching us for partnerships. The Indian Institute of Technologies (IITs) and All India Institute of Medical Sciences (AIIMS), New Delhi, are also collaborating with THSTI for the Center of Biodesign that is being created as part of THSTI. This center would mainly focus on biodevices and diagnostics. If we compare the allocation of space to biotechnology companies in Biotech Parks and the Faridabad Biocuster, the expertise is a major missing link. The development of requisite expertise for product development, is a focus area here, at THSTI.I feel the present curriculum is up-to-date. We need a variety of subjects in the curriculum, because students require the temperament for research in biotechnology. Almost 90 percent of the students are unemployed. This is because the fundamentals are unclear, and most public and private institutes lack the required infrastructure to impart this. The right training, I think, is missing. Q What is your opinion on the progress and hiccups in the Indian biotechnology industry? Do you think there is a need for changes, in the regulation? There has been a sea change in the last five years in research facilities and infrastructure. There was a time when funding was an issue; but now, the real issue is quality manpower. Most professors at universities have limited industry knowledge. Competencies required by the industry are different, than what is taught in the classroom. The industry wants manpower and the academia is not providing this. Hopefully, in the future some industry knowledge will be instilled in the students. On the regulation front, I feel we are following the regulations in the west; while actually, the need of the hour is to have our own set of regulatory guidelines. For example, JE Vaccine is treated as a Biosafety Level 3 (BSL3) in the US. It is exotic in US, but found with high frequency in India. Therefore, we should not be bound to conduct research in BSL 3, in India. This is just one of many such examples. According to my understanding, we should be able, and willing, to change regulation, depending on the need and the situation. Q What are the challenges that researchers face in India? The lack of availability of quality equipment has to be addressed. There are many bureaucratic hiccups that hinder researchers. It is surprising that we import water baths and centrifuges from China, when we can invent and manufacture them here. I wonder why we cannot invent and develop good biosupplier equipment in India itself. Proper monitoring of the funds needs to be done by the DBT. There should be greater accountability for universities; besides stringent checks on recruitment. Presently, a number of biotechnology colleges have mushroomed; and most universities have started courses, without adequate manpower and infrastructure. These institutes need to be better monitored by the government bodies. Q What kind of translational model is being followed by THSTI? Are there any time-bound projects that are followed upon? The onus of THSTI is mainly on the product outcome, and definitely not on the publication of papers. We will have a mix of both fundamental sciences and translation of basic ideas into something that benefits the common people. However, setting deadlines for product outcome is not realistic in cases like developing a vaccine. The appropriate measures to achieve the outcome will surely give an opportunity for substantial experience. Rahul Koul in New Delhi ]]> <![CDATA["India is important for our organic and inorganic growth"]]> https://biospectrumindia.com/news/95/4512/india-is-important-for-our-organic-and-inorganic-growth.html https://biospectrumindia.com/news/95/4512/india-is-important-for-our-organic-and-inorganic-growth.html Thu, 07 Oct 2010 13:27:00 +0530 —Andreas Fibig, CEO & chairman, Bayer Schering Pharma Bayer Schering Pharma (Bayer), Germany’s leading specialty pharmaceutical company, has developed new drugs in oncology, cardiology, ophthalmology, and molecular imaging. The company has also announced its plans to increase its presence in Asia Pacific markets in particular, and in the global markets in general. Mr Andreas Fibig, CEO & chairman of the board of management, Bayer Schering Pharma, discusses the company’s future strategy with BioSpectrum. Excerpts: Q What is Bayer Schering's current position in the global pharma market? Bayer Schering Pharma (Bayer) is one of the 10 largest specialty pharmaceutical companies in the world. We market our products in more than 100 countries. Bayer comprises four business units: diagnostic imaging, general medicine, specialty medicine and women’s healthcare. Currently, we invest 15 percent of our net sales on research and development (R&D). We intend to invest more in R&D of innovative drugs and novel therapeutic approaches; and make essential contributions to medical progress in four core areas: oncology, cardiology, gynecological therapies, and molecular imaging. Bayer employs about 36,000 people worldwide with more than 5,900 working in R&D. Q What kind of innovative drugs are being developed by Bayer? Bayer has a strong phase III pipeline which is growing well, and we plan to launch five-to-six major products in the next three years. In oncology, we have developed Nexavar for liver cancer, renal cancer, thyroid cancer, and breast cancer indications. It is the only approved drug in the world with overall survival benefit in liver cancer. The drug is under a comprehensive development program, with phase III trials underway for lung cancer, thyroid cancer, and breast cancer indications. At the recent European Society of Cardiology Congress in Stockholm (Sweden), on Sep 1, 2010, Bayer also announced success of its oral anticoagulant Xarelto (Rivaroxaban) for prevention of recurrent venous thromboembolism (VTE) in patients with acute symptomatic deep vein thrombosis (DVT). The VTE is the third most common cardiovascular disease in the western world. Xarelto has undergone an unprecedented, extensive clinical trial program, in terms of difference and the number of patients. Riociguat is another compound from Bayer that has demonstrated clinically meaningful improvement in pulmonary hypertension (PH). PH is continuous high blood pressure in the pulmonary artery, a critical blood vessel that channels blood from the heart to the lungs for re-oxygenation. With its VEGF-Trap Eye product, Bayer has recently also entered the growing ophthalmology market. VEGF Trap Eye, developed in partnership with Regeneron, is a potential cure for wet age-related macular degeneration (AMD), which is a leading cause of acquired blindness in the elderly. The product is under phase III trial with a broad clinical development program underway. Q In Asia Pacific, how does Bayer plan to deal with the competition? Europe is important to us, but the fastest growing markets for us are Asia Pacific and Latin America. We are also driven by developments in China and Japan; where we are building on our strength. Currently, European countries are enacting on healthcare reforms, to make sure they keep their budgets tight. In Germany, for example, from August onwards, the prices for innovative medicine were reduced by 10 percent; so the growth for our industry in Europe will be sluggish for this and next year; and therefore, the focus is mainly on many of the emerging markets, to help more patients and optimize our results as well. Some of the differentiating factors for Bayer to be in Asian markets are that we have a good insight in market dynamics, besides a strong parity in many of the Asian markets. We realized the value of Asia and invested sooner, to make sure we are present there. We certainly have manufacturing and development facilities on the ground, which is the secret of success in Asia. In a way, we punched our way there, as we set up our operations early. Bayer is also looking at offering tailor-made product portfolio to Asian markets. Q What is Bayer’s China strategy? Bayer is closely working with the Chinese government on its “Go West” initiative. We all know it is on the minds of the government to improve the rural healthcare in China. In particular, we have tried to customize our product portfolio for these areas. We also have an exclusive agreement with top 300 hospitals in China where we educate doctors who sponsor the rural expansion. We have also improved medical education in rural areas, as we have people from Bayer Schering on the ground, in Tier 4 and 5 cities. We have expanded the team to 600 people and plan to increase it to 800, by next year. Also, Bayer’s R&D center in Beijing shows its commitment to the development of products in China. We have collaboration with Tsinghua University in China, where we conduct research and clinical trials for the Asian population. Q Any reasons why Bayer is almost invisible in India? Any plans to step up operations in India? Bayer and Bayer Schering Pharma have so far not had a significant presence in India. The reason is that India has many strong local players; and it is tough to figure out how one can grow in India. Most of our pharmaceutical products are relatively small. For example, a product which is 1,213 (€20) is a blockbuster product in India, but is not used in other countries. At the moment, we are trying to figure out a way how we can increase our investment in India, because we believe, India will be a prominent market for us in terms of organic and inorganic growth. Bayer does have some research collaborations in India, where Indian companies help develop parts of Bayer’s portfolio, in very early stage. Q What is Bayer’s vision for the next five years? Bayer is improving its R&D productivity. We plan to focus on market access and clinical trials that we really need. We want to make sure our products are rightly priced. Our focus for the next five years is on how we can alter our product portfolio according to the needs of Asia Pacific countries, as that big market opens for us. Vantika Dixit in Stockholm, Sweden (Vantika Dixit was in Stockholm at the invitation of Bayer Schering) ]]> <![CDATA[GE Healthcare bags FICCI Healthcare Excellence Award]]> https://biospectrumindia.com/news/95/1639/ge-healthcare-bags-ficci-healthcare-excellence-award.html https://biospectrumindia.com/news/95/1639/ge-healthcare-bags-ficci-healthcare-excellence-award.html Thu, 07 Oct 2010 13:25:00 +0530 GE Healthcare, the Indian healthcare division of General Electric Company Worldwide, has been awarded the Federation of Indian Chambers of Commerce and Industry's (FICCI's) Healthcare Excellence Award for taking healthcare to the masses. The award was handed over by Dinesh Trivedi, Minister of Health (State), Government of India, in New Delhi, along with film actor and chairman of FICCI Entertainment Committee – South India, Kamal Haasan. The FICCI Healthcare Excellence Awards celebrate the spirit of excellence in India's health services industry, thereby encouraging initiatives in urban, semi-urban and rural areas; to provide accessible and affordable quality healthcare to all. While congratulating the winner, Shobha Mishra Ghosh, director of FICCI, said, “One-hundred-and-thirty nominations were received for FICCI Healthcare Excellence Awards 2010, a forum which was set up to recognize innovative and inclusive healthcare practices in India. FICCI is pleased to recognize GE Healthcare for its significant, continued efforts in taking healthcare to the masses affordably.” V Raja, president and CEO, GE Healthcare, India, said, “It is a great honor to be recognized for our efforts in making healthcare accessible and affordable to the masses in India, with the same quality that is available in the western world. It reflects our commitment to GE Healthcare's vision of "healthymagination" to create a healthier world, in an affordable and accessible way.” ]]> <![CDATA["â€œMalvern steps up India investment to deliver high level service"]]> https://biospectrumindia.com/news/95/2090/malvern-steps-up-india-investment-to-deliver-high-level-service.html https://biospectrumindia.com/news/95/2090/malvern-steps-up-india-investment-to-deliver-high-level-service.html Thu, 07 Oct 2010 13:21:00 +0530 â€“ Stuart Wakefield, director, Malvern Aimil Instruments, Mumbai In May 2008, UK-based Malvern Instruments and Aimil, Malvern's long-term distribution partner in India, joined hands and established a new company, Malvern-Aimil Instruments. Together, the companies have built a strong reputation for the supply and support of systems for particle characterization, rheological measurement and chemical imaging, to a wide range of sectors including life sciences. The joint entity also provides training and application support to the Indian biopharmaceutical industry. In an exclusive interview with BioSpectrum, Stuart Wakefield, director of Malvern Aimil Instruments, tells us about the company's investment plans for India. Q How favorable is the Indian life sciences market for Malvern Aimil Instruments? Indian life sciences market is very favorable for Malvern Aimil Instruments. Biotechnology is relatively a new sector in India, which is growing rapidly; and that creates more demand for different measurement technologies. Malvern has an important role to play in fulfilling this demand. In the life sciences market, there is a pressing requirement for protein characterization tools. Malvern Aimil Instruments offers a range of solutions, based on systems that can be configured to meet the special requirements of laboratories. These include the Zetasizer family, which uses dynamic and static light scattering to measure size and molecular weight; and the full range of Viscotek advanced size exclusion chromatography (SEC) systems and detectors. These are used for the rapid, reliable characterization of both molecular weight and molecular structure. Q Could you elaborate on some of the achievements of Malvern in India? The inauguration of the third Center of Excellence in India on February 10, 2010 has been a major milestone for Malvern in India. Located in New Delhi, and designed to serve customers in the north and northeast regions of the country, the new Center of Excellence houses laboratories that are equipped with a range of Malvern systems, and staffed with a full-time applications team. The team provides demonstration; deliver training, applications and technical support; and undertake sample analysis. Direct support for Viscotek GPC/SEC systems in India is provided as a result of Malvern's acquisition of Viscotek in 2008. Our investment in this Center underlines our objective to offer exemplary customer support across the globe. The new center enables us to deliver increasingly local support to our customers in India, effectively and in a timely manner. We make sure that all the users of our systems enjoy the same consistently high levels of support from all across the world. With respect to company growth, despite 2009 being a challenging year in many ways, globally, from sales perspective, Malvern has had a best year ever. The response to the joint venture, Malvern Aimil Instruments, has been extremely positive, and has even exceeded expectations. Q What are the major areas of focus for Malvern Aimil Instruments in India? Malvern aims to strengthen its base in providing tools to life sciences companies for R&D and manufacturing in India. We would like the country's industrial and research communities to get the same benefits that other global customers are getting from Malvern, and we are working hard to achieve this. The wide range of material characterization offering of Malvern allows it to focus on all major areas of the life sciences sector. For nanomaterial characterization, the Zetasizer family and Viscotek advanced SEC systems find application across a range of sectors; but are particularly valuable for protein characterization, and in the development of drug delivery systems. Q What are the future plans of Malvern and what are the new products in the pipeline? Malvern systems are used in many areas of science and technology, with increasing application of nanomaterials, smart coatings, new methods of delivering drugs and high-tech building materials. The unique combination of materials characterization techniques that Malvern offers, has a valuable contribution to make, in driving progress and in increasing manufacturing productivity. In addition to launching new products, the company continues to focus on developing new ways to support customers. While the right products are clearly essential, it is increasingly a company's ability to communicate and deal efficiently with customers to make a difference. Malvern's service and support is unrivaled and distinctive, and we will continue to invest in upgrading our services. Q How do you think the launch of the Center of Excellence in New Delhi will contribute to the growth of Malvern? As mentioned, the opening of the Center of Excellence has been a key achievement for Malvern in the last year. The center has a major role to play in Malvern's support infrastructure in India; and it also ensures that users of our system take advantage of the global quality standards offered by Malvern. The center gives Malvern a unique position in terms of support capability within the region, and is already clearly appreciated by our customers. Q What are the future plans of the company in India? The growth of Malvern Aimil in India is likely to reflect Indian government's projections for growth, with increasing sales in a number of sectors. The successes of Malvern Aimil and the growing number of Malvern customers in India, are fueling the need for more training, support, and facilities for delivering fruitful results. The new Center of Excellence underlines our commitment to ensure that we have the adequate infrastructure and expertise in place, to fulfill all the needs of our customers. We will continue to invest more, to enhance delivery of high level service in every aspect of customer needs. An area of major investment in recent years has been the Malvern Instruments' website, which is packed with information and educational materials, accessible to customers and non-customers alike. Nayantara Som in Mumbai ]]> <![CDATA[Liposomal Drug Pioneer]]> https://biospectrumindia.com/news/95/4038/liposomal-drug-pioneer.html https://biospectrumindia.com/news/95/4038/liposomal-drug-pioneer.html Thu, 07 Oct 2010 13:19:00 +0530 Despite a thriving generic, formulation and bulk drug industry, India has lagged in developing skills to support discovery-oriented innovative research. However, the Indian drug discovery research is catching up slowly and steadily. In this special series BioSpectrum profiles inimitable contribution of Dr Jitendra N Verma and this emerging area of liposomal drugs After upholding the Trade Related Aspects of Intellectual Property Rights (TRIPS), committing to recognize product patents, Indian companies, in the last decade, have invested in innovation-led drug discovery and produced a reasonable talent pool in biological sciences. This month, in CSO Series, BioSpectrum brings you the achievements of Dr Jitendra N Verma, a senior scientist and managing director of Lifecare Innovations based in Gurgaon. Experience and expertise With a masters degree in science from Allahabad University and PhD from PGIMER, Chandigarh, Dr Verma has 32-year of academic and industrial research experience. He specializes in infectious diseases, NDDS and vaccine development with an expertise in a variety of disciplines, including protein and lipid isolation and characterization, human hybridoma development, drug targeting, liposome technology, vaccine delivery, molecular biology and immunochemistry. His areas of research have been application of liposome technology for development of pharmaceuticals, vaccines and diagnostics, development of nano-drugs, bio-chemistry and metabolism of lipids. Besides the scientific background, Dr Verma’s management background includes implementing successful research, development and marketing strategies, including commercialization. Known as a person with straightforward approach, he has numerous achievements to his credit. Distinct achievements include the development of first liposomal product of India which is a syphilis test. He is also the founder of the first company, which focuses on controlled release drug formulations, in India. Lifecare Innovations has launched Fungisome, which is said to be the most effective anti-fungal drug in the world. The company has also launched two other new liposomal drugs. Now Dr Verma is developing a sustained release oral nano-drug against tuberculosis. He has several patents, four national awards, a state award and a research foundation’s Scientist of the Year award in his kitty. Leading liposomal revolution Dr Verma was engaged in medical research at University of Pennsylvania, Northwestern University, Georgetown University and Walter Reed Army Institute of Research in the US. Known for his expertise in life sciences and biotechnology, Dr Verma was acclaimed for promotion of R&D and later, commercializing their outcome by industry-academia interactions and public-private partnerships. He has pioneered development of NDDS-based liposomal and nano-drugs. As a world leader in liposome technology application for drugs, diagnostics and vaccines, he developed and commercialized India’s first liposomal product and world’s only liposomal diagnostic-liposome agglutination test for Syphilis. He has contributed to Asia’s first anti-fungal drug Fungisome — a liposomal amphotericin B. Working on malaria vaccine, Dr Verma was the first to report that liposomal vaccines elicit cellular immune response necessary for protective immunity. He is presently involved in developing liposomal and nano-drugs for the treatment of tuberculosis, cancer, leishmaniasis and fungal infections. By applying science and technology in everyday life, Dr Verma has been keenly involved in translational research resulting in a number of publications, reviews and patents to his credit. In May 2009, a jury comprising officials from British High Commission, International Business Wales (IBW) and Ernst & Young selected Lifecare Innovations as the winner for Technium 2009 – a global business contest based on emerging technologies and innovations. The Technium Challenge, established in 2003, is a business planning competition, which identifies and supports innovative businesses with high growth potential to invest in Wales, UK. Lifecare Innovations’ business plan on Fungisome emerged as the winner owing to its merits in treating systemic, invasive or topical infections. This anti-fungal drug is said to be the only drug and Lifecare Innovations the only pharmaceutical company among the six country winners of Technium Challenge 2009, which included a company each from the US, Canada, South Africa, Australia, New Zealand and India. Exploring new possibilities Under the leadership of Dr Verma, two new liposome technology-based formulation for the treatment of psoriasis, viz Lipotar and Lipotar-S, are scheduled for launch. Also, the Drug Controller General of India (DCGI) has approved the company’s two novel nano-drug formulations for treating TB. Lifecare Innovations is also working on a project for the development of effective anti-malarial treatment options. For the project, it has partnered with International Center for Genetic Engineering and Biotechnology (ICGEB) New Delhi; Birla Institute of Planning and Technology (BITS), Pilani; and University Health Network (UHN), Canada. This research project would facilitate licensing and commercialization of the discoveries. Also, the company’s R&D, product development, process development, scale-up, pilot plant and production center at Biotech Park, Lucknow, is expected to become operational by the end of 2010. As an extension to its R&D center, the company has set up Lifecare Innovations Laboratory for Translational Research in Nanomedicines at Biotech Center, University of Delhi. The laboratory has attracted attention of researchers on novel drug delivery systems. The current interests of Dr Verma include the application of nanotechnology and liposome technology for the development of pharmaceuticals and vaccines. Talking about the nanotechnology research in India, he says “There is a need for the allocation of funds separately for nanobiotechnology and specifically for the product development and clinical trials. Only then we can see some visible progress in this field.” Lifecare innovations has also partnered with PGI Chandigarh, Punjab University and IIT on the development of nanoliposomal drugs. Dr Verma feels that more partnerships between the academia and industry in this particular sector will help in bringing the products to the market. “The research going on in the academic and research institutes have not reached to the manufacturing stage and tends to get lost only due to lack of coordination between the public and private sector.” concludes Dr Verma. Eradicating leishmaniasis and kala-azar Leishmaniasis is caused by macrophage resident intracellular protozoan parasites Leishmania donovani, Leishmania infantum and Leishmania chagasi. Parasite transmission occurs through the bite of infected female phlebotomine sandfly. One-third of the new cases of leishmaniasis are visceral leishmaniasis (VL) and 90 percent of the VL cases are prevalent in Bangladesh, Brazil, India, Nepal and Sudan. India alone accounts for one-fourth of the total worldwide incidents. Strategic suitability of lipid formulations of Amphotericin B for the treatment of visceral leishmaniasis emanates from several factors viz. leishmania resides in the macrophages, liposomes are rapidly taken up by the macrophages, Amphotericin B is an effective anti-leishmanial drug, and Amphotericin B can be formulated as liposomal preparation. All of these facilitate targeted delivery of Liposomal Amphotericin B to the desired site for anti-parasitic action and thus reduces the drug’s toxicities. Additionally, liposomes offer an amplification effect, through concentrated encapsulation of numerous molecules in each liposomes particle which are delivered at the desired site of action. Liposomal Amphotericin B has been used extensively throughout the world as the best option for treatment of VL even in cases resistant to standard drugs. Fungisome has  shown to have proven advantage over conventional drug regimen in the treatment of visceral leishmaniasis in India. Tissue distribution of Fungisome has been studied in experimental animals infected with Leishmania donovani. At the maximum tolerated doses of conventional treatments and Fungisome, higher levels of Amphotericin B were achieved in liver and spleen in the mice treated with Fungisome. In comparison, conventional Amphotericin B was found to be less effective at the tolerated doses. Similarly, kala-azar is a major public health problem in certain parts of India. Standard treatment involves use of antimonials and sodium stibogluconate. Considerable resistance to the standard drugs has pushed the need to look for alternative drugs. Amphotericin B has been found clinically effective even in resistant cases of kala-azar. Use of Amphotericin B, however, is restricted due to its well-known toxicities. Rahul Koul in New Delhi ]]> <![CDATA["We want to be recognized as a clinical development organization"<br>]]> https://biospectrumindia.com/news/95/2602/we-want-to-be-recognized-as-a-clinical-development-organizationbr.html https://biospectrumindia.com/news/95/2602/we-want-to-be-recognized-as-a-clinical-development-organizationbr.html Thu, 07 Oct 2010 13:13:00 +0530 -Ronald Semler, founder and Dr Krathish Bopanna, president, Semler Research Centre Semler Research Center (SRC), founded in 2006, offers a full range of contract research and developmental services, enabling global life science companies to significantly enhance their R&D success, both from a cost standpoint as well as shorter time lines. SRC is part of US-based Semler group of companies, and has state-of-the art research and clinical centers in Bangalore and Salem. SRC's solutions cover formulation development, preclinical, clinical trials, bio-analytical services, good manufacturing practice (GMP) and quality assurance (QA) consulting. The company has intensified its focus on clinical monitoring services for phase II to phase IV studies, biostatistics, safety management, medical writing, regulatory affairs, dossier preparation and submission to all regulatory agencies across the world. The SRC has set up a new center for drug evaluation and pharmacology research in Bangalore. The company currently has a formulation development center in Bangalore, and a 48-bed clinical research unit in Salem, Ronald Semler, founder, chairman and director of Semler Research Centre; and Dr Krathish Bopanna, executive director & president, SRC, share their company's growth plans with BioSpectrum. Excerpts of the interview: Q What is Semler group's interest in India? Ronald Semler (RS): The parent company Semler Group, entered pharmaceutical services in India because of the thriving generic industry, emerging new drug development capabilities; and the impressive IT talent pool, available for data management. Besides, India boasts of the highest number of FDA plants outside the US. India is also recognized as a hub for CRAMS and clinical trials, with dependable quality standards. Bangalore, the most sought after city worldwide, is home to highly skilled people in life sciences/pharmacy; and has easy accessibility, global exposure; giving us reasons to believe in fostering our growth plans here. In this industry, SRC has seen a sharp growth, due to our in-house expertise and timely deliveries. Q What is the investment in the new facility? RS: We have invested about 44 crore ($10 million) towards setting up facilities in the last three years. We are looking at doubling our investment in the next three years. With this new investment, we will see an increase in our headcount to 500, from the existing 134, in the next two years. Q What are the driving factors for your expansion? Dr Krathish Bopanna (KB): The expansion will enable SRC to complete the loop in the drug development cycle, by providing easy access to state-of-the-art facilities, for early stage research in India. We look forward to added expansion, that will contribute towards further evolution of the Indian contract research and development industry. As a company, we also envisage enormous potential in biometric space, where we hope to delve further, through inorganic growth strategies. Q How does SRC want to make a distinct presence? KB: The team at SRC, which has a combined experience of more than 250 years in the pharma industry, consistently and efficiently moves compounds through the R&D stages to market. In addition, we have a team of highly qualified scientific, operations and administrative staff  both in India and in the US. RS: We have been successful in putting together a team headed by Krathish. Our company covers a whole spectrum of services, starting with formulation development to bioavailability/bioequivalence (BA/BE) to clinical, and even consulting services. The goal is to be a one-stop solution provider to pharmaceutical companies. We have big plans of expanding into newer areas in the coming years. Q Which are these 'newer areas' you plan to expand into? KB: We are thinking of expanding into biomatrix, pharmacovigilance, data management services that support clinical development and related activities. In formulations space, we are looking at some high-end, technologically niche product development. Q How difficult is it for Semler to manage a wide variety of services and diverse groups? KB: There are two areas in business the R space and the D space. The R space is a complicated space that involves innovation and continuous investment. We are at the D space, looking at extending the life cycle chain management of current drugs, or looking at a fresh way of giving exclusivity to a generic partner. Our business model involves very low risk and huge potential. We all know that a lot of drugs are going off-patent, in the next few years. As innovator companies, we are able to give a solution to extend their product's life cycle. What we follow is a very unique hybrid model, and we want to be recognized as a clinical development organization (CDO) - a mix of CRAMS and clinical trials. Most of our competitors either do clinical studies or BA/BE or formulations. At Semler, we have integrated them. We see a number of MNCs coming to India, and acquiring CROs, or small generic companies, to complete their setup. We mimic that model at Semler, for future growth. Q Could you give us a breakup of your revenue contribution from different businesses? KB: In just over three years, we have 23 customers. About 68 percent of them are global customers. Clinical development makes the smallest contribution of two-three percent, since it is a new business. About 20 per cent comes from formulation business, 38 percent from GMP consulting; and BA/BE contributes to about 40 percent. Going forward, we see good growth in our formulation and clinical development businesses, in terms of profitability. GMP consulting will be the precursor for other activities. Q What are your growth plans? RS: Yes, we want to grow our company both organically and inorganically. We are looking at acquisitions, which will be in biomatrix and clinical development areas. KB: We have been growing at 25-30 percent year-on-year, organically. We are looking at taking it to 100 percent, the inorganic way. So, with a mix of organic and inorganic growth, we are targeting growth of 100 percent in the next three years. Jahanara Parveen in Bangalore ]]> <![CDATA[New molecule for diabetes treatment found]]> https://biospectrumindia.com/news/95/2693/new-molecule-for-diabetes-treatment-found.html https://biospectrumindia.com/news/95/2693/new-molecule-for-diabetes-treatment-found.html Thu, 07 Oct 2010 13:11:00 +0530 Advinus Therapeutics, a research-based pharmaceutical company promoted by the Tata Group, has announced the discovery of a novel molecule, GKM-001, for the treatment of type 2 diabetes. The molecule is an activator of glucokinase; an enzyme that regulates glucose balance and insulin secretion in the body. GKM-001 is completely indigenously developed molecule, and the initial clinical trials have shown excellent results for both safety and efficacy. GKM-001 is a novel molecule for the treatment of type 2 diabetes. It is the first glucokinase modulator discovered and developed in India. The success in discovering GKM-001 is attributed to the science-driven efforts in Advinus laboratories, and “breaking the conventional mold” for selection of a drug candidate. Advinus has “Composition of Matter” patent on the molecule for all major markets globally. Glucokinase as a class of target, is considered to be novel, as currently there is no product in the market, or in late clinical trials. The strategy for early clinical development revolved around assessing safety (particularly hypoglycemia); and early assessment of therapeutic activity (glucose lowering and other biomarkers) in type 2 diabetics. The phase I data, in both healthy and type 2 diabetics, shows excellent safety and tolerability over a 40-fold dose range, and desirable pharmacokinetic properties consistent with ‘once-a-day’ dosing. The next wave of clinical studies planned, continues on this strategy of early testing in type 2 diabetics. Right behind the lead candidate GKM-001, Advinus has a rich pipeline of back up compounds on the same target. These include several structurally different compounds with diverse potency, unique pharmacology and tissue selectivity. Having discovered the molecule with early indication of wide safety margins, desired efficacy and pharmacokinetic profiles, the company  now seeks to out-license GKM-001 and its discovery portfolio. Max Neeman expands therapeutic trial Max Neeman International, a full service clinical research organization headquartered in New Delhi, has expanded therapeutic-focused clinical trial services in India. Max Neeman has formed a world class team of medical device experts, specializing in carrying out cardiac device trials – therapeutic, diagnostic and surgical. Along with prior experience in conducting device trials, the specialized Max Neeman team and services adds an enhanced level of company expertise, in conducting simple to complex device studies. Max Neeman has medical device operations and regulatory experience in various other device therapeutic areas as well, including central nervous system and ophthalmology. India is emerging as a destination of choice for medical device development and conducting device trials, as the market for percutaneous coronary interventions has expanded. India’s medical device market is currently valued at 7,672 crore ($1.7 billion); and is projected to grow at the rate of 23 percent annually. Biocon, Teleradiology partner Biocon, a leading biotechnology company in India, has entered into an agreement with Teleradiology Solutions, for getting teleradiology reporting services to Clinigene, its clinical research organization. Teleradiology Solution’s quality-driven reporting process and technology platform benefits biotechnology and pharmaceutical companies; and it also eliminates delays in the completion of clinical trials, by optimizing the radiology reporting process. Dr Kiran Mazumdar-Shaw, chairman and managing director of Biocon, said, “To achieve our main objective of accelerating clinical research, we rely on an adept mix of technology, experience and personal traits. Keeping in line with our mission, Teleradiology Solutions, was the partner of choice to meet our complex image analysis requirements. The signing of this agreement further endorses Bangalore as the hub of excellence, both in biotechnology as well as in high-end healthcare delivery to the world.” Dr Arjun Kalyanpur, managing director and chief radiologists, Teleradiology Solutions, said, “For pharmaceutical and biotechnology companies involved in drug development R&D, delays in the drug development cycle can be an issue of concern. These are, in part, related to delays in reporting of radiologic scans that are performed, to confirm that the patient under treatment has responded positively to the drug being evaluated in the clinical trial. The delays are, in turn, related to the worldwide shortage of radiologists, estimated to be as high as 20 percent in some studies.” ]]> <![CDATA[World]]> https://biospectrumindia.com/news/95/2459/world.html https://biospectrumindia.com/news/95/2459/world.html Thu, 07 Oct 2010 13:06:00 +0530 After producing two cloned buffalo calves, Haryana-based National Dairy Research Institute (NDRI), through the new and advanced hand-guided cloning technique, has cloned another buffalo calf, named Garima-II, on August 22, 2010. This cloned buffalo calf is different from the earlier cloned calf because; in this case, the used donor cell was embryonic stem cell. The world's first buffalo calf through the hand-guided cloning technique was born on February 6, 2009 at NDRI, Karnal and subsequently, the second cloned calf Garima, weighing 43 kg, was born on June 6, 2009 . In earlier cloning, the donor cell was from somatic cells. The donor embryonic stem cell was isolated from the eight-day-old blastocyst. These cells were cultured up to 29-passages (117 days), till it expressed pluripotent marker, and then confirmed to be stem cell. Dr AK Srivastava, director of NDRI, emphasized that this technology could go a long way in helping faster multiplication of superior milch buffaloes in India. â€œAlthough the world's largest population of buffaloes is in India; and they are contributing about 55 percent of total milk production in country, the percentage of elite animals is very low; and there is an urgent need to enhance the population of these elite buffaloes,â€? he said. He further emphasized that there is an acute shortage of good bulls; and the technology of cloning will decrease this gap between supply and demand of breeding the bulls, in the shortest possible time. The team that worked in the production of this cloned calf using embryonic stem cell as donor cell are: Dr MS Chauhan, Dr SK Singla, Dr RS Manik, Dr P Palta, Dr Shiv Parsad, and Dr Aman George of NDRI, Karnal, Haryana. The scientists are of the opinion that the embryonic stem cells have better cloning ability as compared to somatic cells, and the epigenetic reprogramming of these cells is much more efficient than the somatic cells, which are already differentiated and lineage-committed. The scientists believe that the cryopreservation of embryos will need to be made, so that the embryos could be transported and used at several places. The hand-guided cloning technique developed at NDRI, is an advanced modification of the conventional cloning technique. In this technique, immature oocytes were isolated from ovaries and were matured in vitro. These were then denuded and treated with an enzyme to digest the outer layer of oocytes called 'zona pellucida'. The oocytes were then treated with chemicals to push their genetic material to one side of the oocyte. This protruded side was then cut off with the help of hand-held fine blade, for removing the original genetic material of the oocyte. The enucleated oocyte was then electrofused with single cell taken from colony of embryonic stem cells. The resulting embryos were cultured and grown in the laboratory for seven days, to develop them to the stage of blastocyst. The blastocysts were transferred to recipient buffaloes. Pregnancy affected by Fluoride levels Fluoride avoidance reduces anemia in pregnant women, decreases preterm births and enhances baby's birth-weight; reveals leading fluoride expert, AK Susheela, director, Fluorosis Research and Rural Development Foundation, India, in a study published in Current Science. Susheela's team explains that anemia in pregnancy, which can lead to maternal and infant mortality, continues to plague many countries despite nutritional counseling, maternal iron and folic acid supplementation. Anemic pregnant women living in India, whose urine contained 1 mg/L fluoride or more, were separated into two groups. The experimental group avoided fluoride in water, food and other sources and ate a nutritious diet, as instructed. The control group received no instructions. Both groups supplemented with iron and folic acid. Results reveal that anemia was reduced and preterm and low birth weight babies were considerably fewer in the fluoride-avoidance group, as compared to the control. Two stillbirths occurred in the control group, none in the experimental group. According to the findings of the study, fluoride avoidance regenerate the intestinal lining that enhance the absorption of nutrients, as evidenced by the reduction in urinary fluoride, followed by rise in hemoglobin levels. DCGI approves Advaxis' trial for cervix cancer The Drug Controller General of India (DCGI) has approved the human trial of US-based biotechnology company, Advaxis' ADXS11-001- the lead agent for the treatment of cervix cancer. Testing will be completed in 10 days, and patient dosing will begin soon. Currently, nine centers have been identified and have started screening patients with advanced, metastatic cervix cancer for enrollment in this trial. These centers include Tata Memorial, Apollo Hospitals and other centers of medical research excellence in India. Full enrollment is anticipated in approximately three months after the DCGI releases the drug for human use. The phase I trial of ADXS11-001 was intended to assess safety, and like all phase I trials were not powered for efficacy, and so no conclusions can be made based on the small number of patients treated. However, in this trial, the median survival was 347 days; and the one-year survival was 53 percent. Patients will be randomly assigned to receive either three administrations of ADXS11-001 or a single dose of the immunotherapy, followed by cisplatin treatment, and a three-course regimen of ADXS11-001.GCE commits 450 crore The sixth round of Grand Challenges Exploration (GCE) initiative of Bill & Melinda Gates Foundation has committed 450 crore ($100 million) to encourage scientists worldwide, to expand the pipeline of ideas to fight the world's greatest health challenges. This initiative encourages innovative and unconventional global health solutions; and is first-of-its-kind for the foundation that uses an agile, accelerated grant-making process. Launched in 2008, GCE Grants have already been awarded to 340 researchers from 34 countries, including three from India. Initial grants will be 45.01 lakh ($100,000) each, and projects showing promise will have the opportunity to receive additional funding of up to 4.50 crore ($1 million). The grant program is open to anyone from any discipline, from student to tenured professor, and from any organization â€“ colleges and universities, government laboratories, research institutions, non-profit organizations and for-profit companies. One of the primary objectives of GCE is to involve scientists around the world, who do not typically work in global health. This includes innovators in Africa, Asia, and other parts of the developing world; from complementary disciplines; the private sector; and young investigators. The applications for Round Six GCE will be accepted till November 2010. So far, three Indian projects have won the grant in Round Three. These include Dr Ranjan Nanda, Dr KVS Rao and Virander Chauhan of the International Center for Genetic Engineering and Biotechnology (ICGEB), New Delhi; Dr Abani Nag and Dr Amiya Hati of Vivekananda International Health Center in Kolkata; and once again, the scientists of the ICGEB in New Delhi - Dr Deepak Gaur, Dr Chetan Chitnis and Dr Virander Chauhan. Anti-cancer agent AZD-3965 trials to start Cancer Research UK and its development and commercialization arm, Cancer Research Technology Limited (CRTL), have reached an agreement with AstraZeneca, a global pharmaceutical company, to take compound AZD-3965, an experimental drug to treat a range of cancers, into clinical trial. Under the agreement, Cancer Research UK will fund the phase I/IIa clinical trial of up to 60 patients in 2011. The trial, led by Prof Ruth Plummer, will be managed by its drug development office at Cancer Research UK Experimental Cancer Medicine Center Network. As per the agreement, AstraZeneca can decide if they wish to develop the drug further, based on the clinical trial data results, at the end of the phase I/IIa trial. If it chooses not to, the rights will be given to Cancer Research Technology to secure an alternative partner; and ensure the drug has every possible chance of reaching patients. AZD-3965 targets the monocarboxylate transporter 1 (MCT1), which is essential in cell metabolism. Blocking this transporter limits cancer cells' ability to generate energy, and decreases their ability to survive. The drug is ready to be taken into early phase clinical trials. It is the sixth treatment to enter Cancer Research UK's Clinical Development Partnerships (CDP) scheme. CDP is a joint initiative between Cancer Research UK's Drug Development Office and Cancer Research Technology, to progress promising anti-cancer agents which pharmaceutical companies do not have the resources to progress through early phase clinical trials. ]]> <![CDATA[Pall Corp launches GeneDisc System]]> https://biospectrumindia.com/news/95/2157/pall-corp-launches-genedisc-system.html https://biospectrumindia.com/news/95/2157/pall-corp-launches-genedisc-system.html Thu, 07 Oct 2010 13:01:00 +0530 Pall Corporation, introduced GeneDisc Rapid Microbiology System for advanced microbial quality monitoring. This system represents Pall’s latest quality assurance innovation for the pharmaceutical manufacturing industry. The features of GeneDisc Rapid Microbiology System such as novel, highly-simplified technology, based on bar-coded data input and fewer operator-dependent  steps, enable reliable results. that significantly reduce the risk of user error. The economic design of the GeneDisc System also offers the unique advantage of moving assays to an operator with relatively modest training, freeing up technically-skilled staff, for more demanding duties. GE's Biacore T200 launched GE Healthcare, a unit of General Electric has launched Biacore T200, designed to deliver exceptional sensitivity in the measurement of high-quality kinetic, affinity, concentration, specificity, and thermodynamic interaction data, in real time. The system builds upon the success of the widely adopted Biacore T100. The performance, versatility and sensitivity of Biacore T200, enable analysis of interactions involving the smallest, low molecular weight compounds, interactions of rare targets, and facilitates the analysis of interactions involving G protein-coupled receptors. The outstanding sensitivity of the system also allows antigen immobilization levels so low, that interactions with antibody in solution can be analyzed, without avidity effects, thus adding flexibility to assay design. In addition, the system expands the range of kinetic parameters that can be studied with the highest precision and confidence, from the fastest on-rates to the slowest off-rates. Agilent launches new Workbench Agilent Technologies, a company focusing on bio-analytical measurement business, has introduced the 7696 Sample Prep Workbench, a new instrument for automated preparation of analytical samples. It supports sample preparation for liquid chromatography and gas chromatography techniques. The 7696 Sample Prep Workbench offers customers increased productivity through automation, as well as easy-to-use software and hardware. Waters introduces Ostro plate products Waters Corporation, a global biosupplier company, has introduced the new Ostro sample preparation plate, representing a novel approach for the removal of phospholipids from biological samples. When compared to other phospholipid removal devices and traditional liquid-liquid extraction (LLE) methods, Ostro removes up to 30 times more phospholipids. ]]> <![CDATA[Indians win Indo-UK Biotech Challenge 2010]]> https://biospectrumindia.com/news/95/1557/indians-win-indo-uk-biotech-challenge-2010.html https://biospectrumindia.com/news/95/1557/indians-win-indo-uk-biotech-challenge-2010.html Thu, 07 Oct 2010 12:59:00 +0530 Dr Shivprakash Rathnam,  CEO of Synchron Research Services Monika Verma, CEO of Avancé Phytotherapies Dr Ashwani Nangia, Professor of Chemistry, University of Hyderabad The Indian science team wins the prestigious Indo-UK Biotechnology Challenge 2010. The event was held at Nottingham University on September 3, 2010 at the inaugural function of Academy of Pharmaceutical Sciences Conference, in the UK. The event was organized jointly by Nottingham Business School, IIM, Bangalore, and IIT, Kanpur. The Indian team included Prof  Ashwani Nangia from Hyderabad Central University; Monika Verma, CEO of Avance Phytotherapies, Ahmedabad; and Dr Shivprakash Rathnam, CEO of Synchron Research Services, Ahmedabad. The team presented their proposal entitled ‘chalk2salt’, that basically involves converting the physico-chemically poor drugs into better drugs, with improved properties for better therapeutic value. Dr Russell becomes president of Gene Logic US-based Gene Logic, an Ocimum Biosolutions company, a leading provider of genomic solutions with operations in Hyderabad, has announced the appointment of Dr Norrie J W Russell as its president. With more than 30 years of experience in drug discovery, Dr Russell has vast experience in driving innovation in pharmaceutical discovery and development. He also has experience in leading entrepreneurial biotechnology companies, raising capital, and developing pioneering new technologies. Before joining Gene Logic, Dr Russell has held leadership roles with NovaRx, Invitrogen, Aviva Biosciences, and Lynx Therapeutics. Prior to moving to the US, Dr Russell had a long career at AstraZeneca, where he was the global head of Biological Science and Technology, with responsibility for the application of genomics, genetics and proteomics to both target discovery and the entire R&D process. Stempeutics appoints Dr Majumdar as CSO Stempeutics Research, a group company of Manipal Education and Medical Group, has appointed Dr Anish Sen Majumdar as the Chief Scientific Officer (CSO). Dr Majumdar will lead all the research activities that are done at Stempeutics. He will also guide the research team in various experiments conducted, to achieve the desired results. Dr Majumdar brings with him an in-depth knowledge and rich experience in the field of stem cell research, from both India and abroad. Prior to joining Stempeutics, Dr Majumdar worked with the Reliance Life Sciences Center as vice president. His responsibility there included developing and directing R&D activities in the areas of both embryonic and adult stem cells, including mesenchymal stem cells, ocular stem cells and other somatic cells for therapeutic use in various types of degenerative diseases. Dr Poonawalla gets PAHO, PAHEF award The Pan American Health Organization (PAHO) and the Pan American Health and Education Foundation (PAHEF) have presented Dr Cyrus S Poonawalla, chairman and managing director of Serum Institute of India, with the award for ‘Excellence in Inter-American Public Health’, making him the first Indian to get this prestigious honor. Dr Poonawalla received this award from Dr Mirta Roses Periago, director of PAHO for his extraordinary contribution to eliminate rubella and congenital rubella syndrome in the US. Prior to this award, Serum Institute and its chairman, Dr Poonawalla were honored with the Humanitarian Award by Sabin Vaccine Institute, US, for providing quality vaccines at affordable prices. Ecron Acunova gets new CFO DA Prasanna, founder & chairman of Ecron Acunova (EA), a clinical research organization (CRO), with presence in Europe and India, has announced the appointment of Lalit Kanta Mahapatra as chief financial officer (CFO) of EA. Mahapatra will be based in Bangalore, and will be responsible for controllership, financial management and financial integration of business, across services and geographies. Reporting to the chairman of the board, he will manage shareholders expectations, oversee corporate governance and lead the merger and acquisitions (M&A) activities of the company. Prior to joining EA, Mahapatra worked with Schneider Electric Company as head of finance of the global technology center and the project contracting business. He was part of their global acquisition team, and was instrumental in acquiring companies in India and Europe. ]]> <![CDATA[Avesthagen to identify novel genetic info]]> https://biospectrumindia.com/news/95/1097/avesthagen-to-identify-novel-genetic-info.html https://biospectrumindia.com/news/95/1097/avesthagen-to-identify-novel-genetic-info.html Thu, 07 Oct 2010 12:51:00 +0530 Avesthagen, a leading integrated systems biology platform company, has initiated Avestagenome Project sequencing, a set of 60 closely related human genomes to identify novel genetic information relevant to cancer, metabolic and neurological disorders. Through this project, Avesthagen intends to establish a direct link between genes, genetics and the disorders. It is known that many genes on the human chromosomes may be involved during the manifestation of the above disorders. However, the power of present technologies to discover the causative genes of such disorders is limited. Sequencing the 60 genomes for different disorders will be groundbreaking, as analysis of the mammoth 10 tera bytes of data generated, will enable scientists to discover novel causative genes on the chromosomes which may be indicative of occurrence of cancer, metabolic and neurological disorders. Once completed, there will be a better understanding of the genetics underlying the diseases. The study will help in identifying new and better drugs, specific for the above mentioned disorders. The discovery will lead to identifying bio molecules for the accurate prediction of the disease manifestation. This study is being carried out in partnership with Genome Enterprise, a subsidiary of The Genome Analysis Center (TGAC), Norwich Research Park, UK. The TGAC team, specialists in DNA sequencing and bioinformatics, will use Life Technologies' SOLiD 4 sequencing platform, and will collaborate with the Avesthagen's own bioinformatics experts to analyze and interpret the sequence data. Biocon, CIM in JV for immunology research Biocon, a premier biotech company in India, and the Center of Molecular Immunology (CIM), based in Havana, Cuba, have strengthened their existing research partnership by joining forces for an integrated antibody program in immunology. Both entities have successfully collaborated for almost a decade, on an integrated program to manufacture and clinically evaluate recombinant proteins, with the aim of building a portfolio, based on therapeutic biotechnology products for chronic diseases. Two drugs have already been approved for medical use in India and other territories. A novel monoclonal antibody targeting the Epidermal Growth Factor Receptor for the treatment of cancer, and the human recombinant Erythropoietin, for the control of anemia in chronic kidney diseases were developed under stringent medical regulatory standards. Focusing to build on this successful partnership, Biocon and CIM are moving to create an innovative product pipeline, focused on autoimmune diseases and cancer. Fundamental research performed at CIM and Biocon, has defined the anti-inflammatory capacity of a novel monoclonal antibody, an Anti-CD6 Monoclonal Antibody. This molecule targets lymphocytes, the key players in the immunopathology of autoimmune diseases. Experimental data supports its effect in controlling inflammation, that can cause damage to tissues. The research results have been endorsed by scientific journals, and discussed in international congresses. â€œThis Anti-CD6 targeting antibody is a first-in-class molecule, that has recently transited to advanced clinical trials, for the treatment of psoriasis and rheumatoid arthritis patients,â€? said Dr Kiran Majumdar-Shaw, chairman & managing director of Biocon. DCVMN develops life saving vaccines Bharat Biotech, Hyderabad-based biotechnology major focusing on vaccines, biopharmaceuticals and contract research hosted a four-day Annual General Meet of Developing Countries Vaccine Manufactures Network (DCVMN) from Sep 13-16, 2010. Over 125 participants from 31 vaccine manufacturers, representing 14 countries and 12 international agencies, participated in this year's annual meet. Dr Akira Homma, president of DCVMN, said, â€œDCVMN provides two-third of the vaccines used in the world. The DCVMN is an important partner in the Global Immunization Agenda, as its goals are aligned to Global Alliance for Vaccine Immunization (GAVI).â€? Swine flu casualties continue in India With the monsoon active in India, there has been no decrease in the casualties from H1N1 influenza virus attack. According to Indian Ministry of Health and Family Welfare, the lab confirmed cases reported during the week of Sep 6-12, 2010 were 1,011; with 75 deaths reported during the same period. All 1,011 cases reported during the week were indigenous cases. Out of the 75 deaths reported, Maharashtra has the most victims, followed by Madhya Pradesh and Gujarat. The casualties of swine flu include 22 deaths reported from Maharashtra, 18 from Madhya Pradesh and 15 from Gujarat. Till date, the samples from 177,816 persons have been tested for influenza. 'India BT Industry to reach 36,107 cr by 2015' According to the knowledge report released jointly by the Confederation of Indian Industries (CII) and Yes Bank, the Indian biotechnology industry would grow at a CAGR of 20 percent to achieve a market size of 36,107 crore ($8 billion) by 2015. The report titled 'India Life Sciences: Vision 2015' has attributed the growth to various new developments in the industry, including the launch of numerous initiatives to lend support to the industry by the the union and state governments. While highlighting the rapidly growing market in India, the report has also estimated that India will capture roughly three-to-five percent of the global biopharmaceuticals market by 2015. Indian biotechnology companies have been steadily receiving large orders for combination vaccines from the Central Government, under its numerous immunization initiatives. The demand for specific conjugates in the pediatric and adolescent segment, is also stimulating growth of the market. Breakthrough products, such as Shanchol â€“ the bivalent oral vaccine, jointly developed by Shantha Biotech and International Vaccine Institute, will further boost demand. The report says that the global biotechnology industry is undergoing transition, creating enabling factors that can aid the growth of the Indian biotechnology industry. It suggests that India can play a key role in reducing cost and time-to-market, for new drug development through outsourcing various components of the drug development process. There is an opportunity for research and development (R&D) focused Indian biotechnology companies to enter into such alliances, through collaborative development projects. Netherlands signs MoU with TERI A 15-member delegation from the Utrecht province of the Netherlands, led by The Queen's Commissioner, R Robbertsen, visited India recently, with a mission to explore academics and business cooperation between the Utrecht regions and the Indian counterparts. On Sep 13, 2010, a memorandum of understanding (MoU) was signed between the Utrecht province and The Energy and Resources Institute (TERI) in India, to initiate their European office in Utrecht. Under the existing MoU between the Netherlands and India, Indian private partners can participate in public-private partnerships; and in a way that opportunities can be explored, both for Indian companies in the Netherlands and Dutch companies in India. The areas covered under scientific and industrial collaboration include biomass conversion, energy efficiency, water and sustainable cities. India, Brazil discuss ethanol production India and Brazil are exploring the possibilities of cooperation in production of ethanol and investment in agriculture. A 13-member delegation led by Sharad Pawar, minister of Agriculture, Consumer affairs, Food and Public distribution, Government of India, visited Brazil; and had a bilateral meeting with Wagner Rossi, minister for agriculture, livestock and food supply of Brazil. The delegation met with the officials of the Brazilian Ministry of Agriculture in Sao Paulo on Sep 8, 2010, and the directors of UNICA (Brazilian Sugarcane Industry Association), who made a presentation on the Brazilian sugar and ethanol industry. Medical devices cluster in AP Andhra Pradesh has plans to set up the country's first MedTech Valley, a world-class cluster for manufacturing medical devices and diagnostic equipment near Genome Valley at Shameerpet, in Hyderabad. The state government will provide 1,200 acres of land for the project. In phase I, 200 acres are being developed by the Hyderabad Metropolitan Development Authority. The project will be executed via a public-private partnership model, and will get assistance from the central government for infrastructure development. This cluster is expected to attract global investors in manufacturing of medical devices and equipments; and would provide world-class infrastructure. ]]> <![CDATA[400 global delegates, 700 meetings]]> https://biospectrumindia.com/news/95/1340/400-global-delegates-700-meetings.html https://biospectrumindia.com/news/95/1340/400-global-delegates-700-meetings.html Thu, 07 Oct 2010 12:50:00 +0530 The wide participation of biotech companies at the BIO India International Partnering Conference  at Hyderabad in September showcased their eagerness to work with Indian companies over 400 representatives from 220 companies participated in the two-day Bio India International Partnering Conference held in Hyderabad from September 21-22, 2010. About 60 percent of the representatives were from India, 25 percent of the registered companies from North America, eight percent from Europe, and rest from Asia Pacific region. Representatives of global pharmaceutical and biotechnology companies like Amgen, Merck, GlaxoSmith Kline, AstraZeneca, Eli Lilly, Genentech, Roche, Bristol-Myers Squibb, Inviragen, Novartis Pharma, Novo Nordisk, Biogen Idec, Sanofi Pasteur, Haffmann-La Roche were actively scouting for partnerships with Indian biopharmaceutical companies. The conference also had the presence of venture capital firms, law firms and research organizations; such as venture capital firms like Federated Kaufmann Fund and VIVO Ventures from the US; law firms like Shook, Hardy & Bacon, from the US, seeking partnership with Indian companies. The Biotechnology Industry Organization (BIO) which represents over 1,200 biotechnology companies, academic institutions, state biotechnology centers and related organizations across the US and in 30 other countries, organized this first-ever Bio India International Partnering Conference in Hyderabad, in association with Association of Biotechnology Led Enterprises (ABLE), a 200-member national forum that represents India’s biotechnology sector. Alan F Eisenberg, executive vice president, Emerging Companies & Business Development, BIO, noted, “Of the 1,600 requests received for one-on-one meetings at the two-day forum, we were able to schedule 700 meetings. Besides these scheduled meetings, the event provided a platform for additional one-on-one meetings, for the registered delegates.” At the recently concluded Chicago BIO International Convention 2010, he said, BIO had received 4,300 meeting requests from global pharmaceutical and biotechnology companies, with Indian companies. In addition to the dedicated one-on-one partnering time slots, the conference included a full schedule of company presentations, keynote address; and three panel discussions on Unique Deal Structures, IP and Tech Transfer in India and Financing of Innovation in India. Dr Jeremy Levin, senior vice president, Strategic Transactions Group, Bristol-Myers Squibb and Dr Kiran Mazumdar-Shaw, chairman and managing director, Biocon, gave the keynote address. Also, a short video with message by Dr MK Bhan, secretary, Department of Biotechnology, Government of India, was shown. Sri Mosur, president and CEO, Jubilant Biosys; Dr Rashmi Barbhaiya, CEO & managing director, Advinus Therapeutics; and Achin Gupta, senior vice president, Corporate Strategy, Glenmark Pharmaceuticals; shared their experiences on unique deal structures their companies have established with other global companies, to help prepare new entities considering partnerships with Indian companies. Dr Karen Bernstein, chairman and editor-in-chief, BioCentury, moderated the discussion. Hitesh Sharma, partner and leader, Life Science Practice, Ernst & Young; Sunny Sharma, senior managing director, OrbiMed Advisors; KV Subramaniam, president and CEO, Reliance Life Sciences, shared the recent case studies and novel approaches to the funding of innovation in this emerging market, in reply to the questions raised by Dr Jasmin Patel, managing director, FIL Capital Advisors, who moderated the discussion. Pravin Anand, managing partner, Anand & Anand; Arundeep Pradhan, associate vice president, Tech Transfer and Business Development, Oregon State University; Deepam Mishra, CEO, i2india Ventures; participated in a discussion on India’s proposed Utilization of Public Funded Intellectual Property Bill and its implication for translating research into cutting-edge products; moderated by Thomas Moga of Shook, Hardy & Bacon, US. The panelists discussed its impact on foreign investment, partnership opportunities in India and innovative product development, besides its impact on the biotechnology industry in India. The Indian companies that are spending close to 10 percent of the sales revenue on R&D using cutting-edge technology and tools at the state-of-the-art labs, are keen on partnering with global firms to mitigate the R&D risks. About 25 biotechnology companies both from India and abroad, focusing on developing drug discovery research, through cutting-edge science made presentations on their product pipeline. Companies like Aurigene Discovery Technologies, Biocon, Connexios Life Sciences, Genotypic Technology, Ocimum BioSolutions, Strand Life Sciences, Orchid Research Laboratories, Intas Biopharmaceuticals, Ecron Acunova, Workchardt, NovaLead Pharma, Indus Biotech, Kemwell, GangaGen Biotechnologies, Jubilant Biosys, Incozen Therapeutics and Cellworks Research India; and research organizations like Center for Cellular and Molecular Platforms, shared their organizational vision and their requirement seeking partners. In addition to the above Indian companies, firms from Israel, UK, Germany, Denmark; including Kamedis Laboratories, an Israeli company focusing on creating innovative products for skin treatments; Spectrum Pharmaceuticals, a US-based biopharmaceutical company that acquires, develops and commercializes a diversified portfolio of oncology, and other drug candidates that meet critical health challenges for which there are few other treatment options; The Wellcome Trust, a London-based global independent charity funding dedicated to achieving extraordinary improvements in human and animal health; CureVac, a German biopharmaceutical company specialized in RNA molecules synthesized by chemical and enzymatic means; and Novo Nordisk, a focused healthcare company from Denmark and a world leader in diabetes care, made presentations about potential partnership opportunities with Indian companies. Speaking to BioSpectrum on the sidelines of the conference, BP Acharya, principal secretary, Industries and Commerce Department, Government of Andhra Pradesh, said “Our dream has come true with BIO India International Partnering Conference coming to India. BIO India plays a major role in providing networking platform for global and Indian pharmaceutical and biotechnology companies. We have been in discussions with BIO for past seven-to-eight years. Finally, with the support of ABLE, Hyderabad has hosted the first-ever BIO India conference.” The presence of major players in global pharmaceutical and biotechnology at this event indicates their strong willingness to work with Indian companies. Pleased with success of the conference and the interest among the Indian companies, Alan F Eisenberg announced, “The next annual BIO India conference will be held in Hyderabad on Sept 21-22, 2011.” Narayan Kulkarni in Hyderabad Ranbaxy, Cadila, Aurobindo, Matrix bag Pharmexcil Exports Awards The Outstanding Export Performance Awards and Patents Awards 2009-10 were given away during the ‘Pharma CEO’s Conclave’ held in Hyderabad on September 24, 2010. The event was organized by Pharmaceuticals Export Promotion Council (Pharmexcil), set up by the Ministry of Commerce and Industry, Government of India. In all, 12 awards were presented for export performance. Ranbaxy Laboratories bagged the Outstanding Exports Award in overall category; and Cadila Healthcare received the same in overall emerging category. While Aurobindo Pharma bagged the Outstanding Exports Award Formulations in the overall category, Matrix Laboratories won the same in the emerging category. Speaking on the occasion, K Rosaiah, chief minister of Andhra Pradesh said, “I am very happy to place on record that, after the establishment of Pharmexcil, the exports of our country have grown from 17,060 crore ($3.8 billion) to 39,958 crore ($8.9 billion). Exports have grown with formulations at 58 percent, bulk drugs at 41 percent and herbals at one percent.” ]]> <![CDATA[Trends in proteomics contract research]]> https://biospectrumindia.com/news/95/1431/trends-in-proteomics-contract-research.html https://biospectrumindia.com/news/95/1431/trends-in-proteomics-contract-research.html Thu, 07 Oct 2010 12:38:00 +0530 Dr Richard Lipscombe Dr Richard Lipscombe is the founder and Managing Director of Proteomics International, Australia and an expert in protein analysis. Proteomics International is both a contract service provider and research and development company, focusing on developing value from unlocking the protein code specifically for drug discovery and biological research. Dr Lipscomb is a protein chemist with extensive experience in analysing biomolecules using proteomics techniques. This includes over 20 years international experience in hospital and academic laboratories and commercial organizations in Australia, the US and the UK. Proteomics is analysing all the proteins in a cell, tissue or organism, or more simply, a system. Exemplifying the practical term of system, proteomics is used narrowly to study specific pathways within a cell, or broadly, with the example of the Human Liver Proteome Project centred in China, to map every protein involved in the operation of the second most complex organ in the human body. Advancements in proteomics Most developments in proteomics and protein discovery have focused on a systems approach, and specifically system comparison and biomarker discovery. Applications are enormous, from human diseases such as cancer and diabetes, to salt tolerance and pathogen resistance in crops. This is achieved by comparative proteomics using a series of separation techniques followed by the identification power of the mass spectrometer. Sensitive mapping of many protein and peptide systems is possible â€“ 50 micrograms of protein extract from a cell culture can be sufficient to identify over 1000 proteins from that system, or a single scorpion sting can be mapped to identify over 300 new peptides (each a potential new drug). Whilst as little as 10 years ago, it was standard practice to identify one protein in 24 hours with Edman N-terminal protein sequencing, it is now possible to sequence and reliably identify one protein in one minute with a mass spectrometer. Liquid chromatography (HPLC) has taken over from traditional two-dimensional gel electrophoresis as the method of choice for protein separation. The most successful techniques are based on the MudPIT (multidimensional protein identification technology) approach, which uses a series of chromatography steps (usually ion exchange and reverse phase) to separate a complex mixture of protein fragments. An essential step is that the entire protein sample is first digested into peptides before it is applied to the HPLC. This ultimately presents a bioinformatics challenge, but saves time because the sample (i.e., all the peptides) can be directly analysed by mass spectrometry. In order to compare the differential protein expression of two or more samples, the proteins from each source can be chemically and uniquely labelled before the separation experiment begins. When successful, the comparative analysis produces new information on the key components of the system-discovering biomarkers for that disease or trait. Current approaches seek to improve peptide separation and sensitivity, and an exciting development has been the advent of LC-MALDI MS (liquid chromatography - matrix assisted laser desorption ionisation mass spectrometry), whereby the HPLC eluates are mixed with matrix and simultaneously spotted onto MALDI MS targets. This has a number of advantages:, high-throughput TOF (time of flight) instruments can be used to process the samples; the samples are stable on the target so it can be archived and processed at a convenient time; the samples can be re-analysed. The coverage obtained by the different proteome mapping methods varies, however, LC-MALDI and MudPIT LC/MS have clearly overtaken 2D-gel electrophoresis. Of course, no one approach will tell the whole story. Whichever system is used vast amounts of data are created â€“ nowadays one comparative protein discovery experiment can create nearly a 1Gb file. This requires extraordinary computing power, and centralised super computers that can handle the data of many groups are a sensible solution. The Australian Proteomics Computational Facility is one such example, accepting data from any group in the APAC region. Proteomics and contract research Interest in analysing protein systems in great detail has led to a focus on post translational modifications (PTMs) such as phosphorylation and redox changes of thiol groups. These PTMs allow whole new classes of protein activities to be targeted with exquisite selectivity. The techniques being developed also have another far-reaching benefit: to provide a new suite of tools for the fast emerging biosimilars market â€“ a precision approach to quality control. This rapidly growing market is forecast to be worth a heady 3,45,000 crore ($77 billion) within two years. Biosimilars, also termed biogenerics or follow-on biologics include monoclonal antibody type drugs, and novel medications like insulin, beta interferon, G-CSF and coagulation factors. A growing role for protein analysis CRO's is to offer complete, independent, molecular characterization. This ranges from verification of amino acid sequence to disulphide bridging and ratification of PEGylation sites. Many techniques remain in their infancy in traditional analytical labs, whilst accredited facilities are extremely rare. Agencies such as the FDA are starting to realise the power of this new application of proteomics, and are pressing for reliable mass spectrometry based data. Regional testing authorities such as NATA (Australia), and APLAC (Asia Pacific Laboratory Accreditation Cooperation) are responding and it is probable that ISO/IEC 17025 laboratory standards will become an essential QC requirement for advanced proteomics facilities. The broadening interest in proteins as therapeutic and agri-biochemical targets, or as diagnostic markers, means there are a wealth of projects to pursue, and numerous ways of pursuing them. Appreciating the potential rewards, and the pitfalls, as researchers engage with contract service providers will ensure a faster path to that next protein discovery. References: 1. TIDES 2008 Oligonucleotide and Peptide Technology and Product Development 18â€“21 May Las Vegas; 2. Bringans S.D., Erikson S., Kendrick T., Gopalakrishnakone P., Livk A., Lock R. and Lipscombe R.J. (2008), Proteomic Analysis of the Venom of Heterometrus longimanus 3. (Asian Black Scorpion), Proteomics, 8, 5, 1081-96.; 3. RNCOS (http://www.in-pharmatechnologist.com/Industry-Drivers/Protein-therapeutics-worth-77bn-by-2011-says-RNCOS) ]]> <![CDATA[Actis to bring down cancer treatment cost]]> https://biospectrumindia.com/news/95/2730/actis-to-bring-down-cancer-treatment-cost.html https://biospectrumindia.com/news/95/2730/actis-to-bring-down-cancer-treatment-cost.html Thu, 07 Oct 2010 11:05:00 +0530 Mumbai-based Actis Biologics has a vision to bring to market, high-end technologies and biotechnology products, at affordable prices. With its star product, 'Angiozyme' recently entered phase III trials in India, this dream could perhaps see the light of the day A successful business plan is an amalgamation of ideas, passion, putting in place a sound team, getting in the right investors, funds, and above all, not turning a blind eye to the failures that might come in the way. In 2003, when a group of scientists in San Francisco (US) came together to form Actis Biologics Inc, their sole purpose was to pool in their patents, research accomplishments, and funds; not just to derive maximum return on investment, but also to come out with high- end technologies manufactured at low costs, so that the end product would reach the consumer at an affordable price. Hence in this case, the germination of an idea was not enough; but it required a sound business plan and tactful dealing of logistics. Similarly, setting up its Indian counterpart, Actis Biologics Private Ltd (ABPL) was no cakewalk for the founders of the company. Challenges came in the form of limited funds, limited manpower, finding like-minded partners on board, and procuring the right technologies. With the business strategy to be a low-cost manufacturer of products, without compromising on manufacturing quality products in the field of biotechnology, today, the company has a host of exciting molecules in the pipeline, with their 'star product' for colorectal cancer molecule 'Angiozyme' recently entering phase III trials in India. Once successfully commercialized, Angiozyme is expected to reduce the cost to treat cancer to one-fifth the conventional costs. The Genesis In 2003, a group of biotechnology scientists congregated in San Francisco with biomedical engineer Sanjeev Saxena, co-founder and molecular biologist Dr Dave Toman besides other practicing clinicians; to give expression to Actis Biologics Inc. Recalls Sanjeev Saxena, CEO, Actis Biologics, â€œBesides contribution of patents and research accomplishments, this group of engineers, scientists and doctors, has contributed their limited funds to build the company, and expand to other parts of the world. Thus, Actis Biologics Group was formed.â€? Within a few years, Actis Biologics Group spread its wings and established presence in India and Malaysia. During various visits and interactions with the Government of India, particularly, the Department of Biotechnology (DBT) and Department of Science and Technology (DST); it became evident that a market like India was in dire need of a next generation biotechnology company, that had lower cost structure besides a diverse gene pool. With the support of the DBT, Actis Biologics was established in December, 2005; and valuable patents were transferred to Actis Biologics in India. Thereafter, Actis Biologics grew with private investments and support of governmental agencies with schemes such as the Small Business Innovation Research Initiative (SBIRI). The company submitted a project titled â€œDelivery of MSP36 with Lenti Viral Vectorâ€? to the DBT in December 2005, and that was approved for funding in 2006; with the loan sanctioned in April 2007, and funds dispersed in May 2007. In May 2007, Actis entered into a strategic tie-up with the Malaysian government in Melaka, to develop Actis Biocity on the lines of biotech centers in San Francisco (birth place of biotechnology), San Diego, Seattle, Boston in the US. Every business has its set of challenges and obstacles. â€œWe had no money when we started the company, so the issue was how do we in-license and acquire technologies? Further, how do we hire the right people, and motivate them to join and work with us? The other questions, which we had to deal with, were what technologies to bring on board, and who all do we want as partners; writing a business plan and preparing the financial, and then finding the relevant investors,â€? reveals Saxena. And then the issue of pricing the company's shares. Subsequently, after tackling these issues, the funds were raised on a project basis. Even though their biotechnology molecule for colorectal cancer, Angiozyme, held a lot more promise, ABPL was unable to work on further development of this technology, due to limitation on resources. Further, the management had to contend with a paradigm shift of diverse molecules in their portfolio. Business Model ABPL follows a business model that has already been implemented by many international companies, wherein, the company will develop and manufacture products, but market it through experts, who have a large marketing network. However, what is unique about the marketing strategy is to spin each technology platform (after incubation phase) as a separate company; and develop other products using the technology, besides bringing a partner into that spin off venture. â€œAs an example, we already did spin out our CAD technology into a company called Telesto Diagnostics in Malaysia; and are in the process of looking for appropriate partners, to further develop the company, and the various products which will be generated, using this technology,â€? reveals Saxena. On the same lines, Actis Biologics has also incorporated under its banner, Kohinoor Biotech to focus on a ribozyme tech platform; Aum Life Sciences to focus on development of various recombinant proteins and mAbs; Mercury Biotech for the development of gene therapy-based products; and Deep Biotech for development of various immunotherapies, using a novel cytokine. Promises of Angiozyme The company recently made news with its star product, Angiozyme, a biotechnology molecule targeted at colorectal cancer, entering phase III trials in India. The phase III clinical studies are expected to cost the company 233.5 crore ($50 million), a part of which will be funded through soft loans by the DST, Government of India. The phase III multi-centric trials will be conducted among 150 patients in select centres in the country. â€œThe trials are expected to be completed within 18 months from now. The company is also looking at conducting the trials in locations like Malaysia, China, Latin America and the US,â€? confirms Saxena. Angiozyme is a unique technology which is a hybrid of RNA and enzyme; and is, thus termed ribozyme. Since it targets the mRNA, it comes under the category of antisense. As an antisense catalytic enzyme that combines with a specific RNA and then cleaves off, it helps in stopping formation of unwanted blood vessels; thus stops the nutrition from being supplied to tumor cells, and also starving these unwanted cells. But, what is important about this technology, is that it works where ever we need to stop blood vessel formation, be it in obesity, AMD or as a contraceptive, since Angiozyme is a hammerhead ribozyme. â€œWith modifications to ribozyme, we should be able to create other signal blocking mechanisms, or signal enhancement mechanisms to prevent or fight other diseases. Now, specifically, in the case of colorectal patients, the team at ABPL believes it should work by eliminating any side effects, as well as, allowing for subcutaneous injections by patients themselves. Further, it can be made so inexpensively, that it should bring down cost of colorectal cancer care,â€? informs Saxena. The technology proposal was studied in depth by a team of over 20 scientists from various departments (such as DST, ICMR, DBT, DCGI), and was found to have a strong potential, due to its anti-angiogenesis methodology. It was found that the cost of manufacturing this drug in India, and its method of delivery, provided for drug costs to be brought down by a factor of 10; and hence made affordable to the general population. Due to this consideration, DST agreed to fund the project. The market size for Angiozyme just for colorectal cancer in India, is at 1,341 cr ($300 million) and 6,707 cr ($15 billion) on a global basis (Angiozyme can be used for other indications as well, breast cancer for example). Over 1,564 cr ($350 million) has gone in the development of this molecule. It will cost another 290.5 cr ($65 million) to develop this molecule of which 223.5 cr ($50 million) has already been raised. This 223.5 cr ($50 million) has been been funded through soft loans from the DST, Government of India. â€œWe are just starting the process of exploring potential strategic tie-ups and hence it is too early to discuss the same,â€? says Saxena. Other Developments This apart, ABPL's Department for Scientific & Industrial Research (DSIR)-recognized R&D centre is also conducting research of recombinant proteins, gene therapy and antisense drugs. ABPL also has over 20 patents around a very promising technology which was reviewed by the US FDA and given an Orphan drug status. The LIV1 technology is focused on making existing drugs more effective and less toxic, by creating a more targeted delivery mechanism. Looking at the future, growth for the company would come through both organic and inorganic route. â€œThis means, internally through soft loans and grants from the governments of India and Malaysia and the National Institute of Health, USA. We are looking at inorganic growth by raising another 134.11 cr ($30 million)â€?, concludes Saxena. Nayantara Som in Mumbai ]]> <![CDATA[â€œICMR provides encouraging leads for product developmentâ€?]]> https://biospectrumindia.com/news/95/2640/icmr-provides-encouraging-leads-for-product-development.html https://biospectrumindia.com/news/95/2640/icmr-provides-encouraging-leads-for-product-development.html Mon, 13 Sep 2010 12:10:00 +0530 -Dr Vishwa Mohan Katoch, director general, Indian Council of Medical Research and secretary, Department of Health Research, New Delhi The Indian Council of Medical Research (ICMR), New Delhi, the apex body in India for the formulation, coordination and promotion of biomedical research, is one of the oldest medical research bodies in the world. It is funded by the Department of Health Research (DHR), Ministry of Health and Family Welfare, Government of India. ICMR promotes biomedical research in the country through intramural as well as extramural researches, and the DHR aims at bringing modern health technology to people by encouraging, translating and introducing innovations into public health service through research on health-related topics. In an exclusive interview with BioSpectrum, Dr Vishwa Mohan Katoch, director general, Indian Council of Medical Research (ICMR) and secretary, Department of Health Research, New Delhi, shares his views on key operations and priorities of ICMR, translational research, role of DHR and a host of other issues. Q Which diseases are considered as top priority by the ICMR and what are the steps taken to eradicate them? Diseases of major public health importance are our priorities. Communicable diseases such as influenza, poliomyelitis, HIV, tuberculosis, malaria, and diarrhoea; non-communicable diseases such as diabetes mellitus, cardiovascular diseases, cancer, and central nervous system-related disorders; reproductive health issues such as development of new contraceptives for both male and female, infertility, reproductive tract infections, menopause and osteoporosis; and healthcare issues related to tribal and marginalized populations, are some of the priority areas for ICAR.  Q What are the initiatives taken by the ICMR to promote translational research?    In the 10th Five Year Plan, the ICMR gave importance to developing infrastructure for conducting fundamental and strategic research. This has resulted in research that has provided encouraging leads for developing new products. In the 11th Five Year Plan, efforts are taken to develop products. Based on a list of programs that have the potential for translation into the National Health Care Program/Clinical Practice, the secretary of the DHR, had identified about 103 technologies/programs out of which 53 top priority technologies/programs were short-listed on a priority basis.  The Scientific Advisory Group took stock of the technologies developed and recommended that a unit  be created at the ICMR headquarters, and cells to be created at the institute-level, to closely monitor the progress, and extend all assistance translational research. Accordingly, 26 translational research cells with three to four members, and a chairperson have been formed at each of the 26 ICMR's institutes/centers. The list of these technologies are updated every three-to six months depending on the priority of the project. Moreover, scientists at some of the institutes have also planned to initiate new projects under translational research. Workshops were also conducted for dissemination of scientific knowledge for its wider application and its potential for commercialization. Q What kind of collaborations are initiated by the ICMR with the industry? The ICMR is partnering with the industry in development and evaluation of new vaccines, drugs  and diagnostic tests. Some of the technologies developed at the ICMR institutes are shared with the National Research Development Corporation (NRDC) and the Biotechnology Industry Research Assistance Council (BIRAC)  for commercialization. Q What is the  role of DHR in transferring technology for the benefit of people? Development of infrastructure for technology transfer is the thrust area of the DHR, whereas the ICMR serves as the fulcrum for all scientific activities aimed at generation of knowledge and its evaluation. The DHR supports medical colleges and state governments for setting up of model rural research units, virology networks, and specialized centers; and also for improving research governance. The technologies that are developed by the ICMR institutes would be considered on a priority basis, to develop products that are useful for the community. Q Which are the areas of focus for ICMR in the coming years? The ICMR is addressing issues related to encouraging healthcare research in medical colleges, strengthening capabilities and skills of the institutions for diagnosis of viral diseases; translation of promising leads generated in the institutes of the ICMR into products; and setting up of specialized centers in project mode. And at the same time, if these centers need long-term support, they would be moved under the DHR. Our future focus is on research programs aimed at control and management of infectious diseases, improving the healthcare of people living in the North-Eastern States and also in marginalized populations. Q What are your views on the regulatory mechanism existing in India? Technology should reach the people. However, there is a need for strict evaluation, and for that purpose, if more people are required, then we will recruit accordingly. Also, there should be a specific timeframe for resolving all the related issues. Rahul Koul in New Delhi ]]> <![CDATA[â€œICGEB set to make headway in dengue researchâ€?]]> https://biospectrumindia.com/news/95/2016/icgeb-set-to-make-headway-in-dengue-research.html https://biospectrumindia.com/news/95/2016/icgeb-set-to-make-headway-in-dengue-research.html Mon, 13 Sep 2010 12:04:00 +0530 -Dr Virander S Chauhan, director, ICGEB, New Delhi Headquartered in Trieste, Italy, the International Center for Genetic Engineering and Biotechnology (ICGEB) has two more components, one each at Cape Town (South Africa) and New Delhi (India). A part of the United Nations system, the center forms an interactive network with affiliated centers in 60 member-states. The New Delhi-component of ICGEB is dedicated to advanced research and training in molecular biology and biotechnology, and holds out the prospect of advancing knowledge and applying the latest techniques in the fields of biomedicine, crop improvement, environmental protection/remediation, biopharmaceuticals and biopesticide production. In an interview with BioSpectrum, Dr Virander S Chauhan, director, ICGEB, New Delhi, shares his views on different topics related to the center, biotech industry, tuberculosis (TB) research and many other issues. An expert in malarial research, Dr Chauhan, joined ICGEB in 1988, and has been responsible for many advancements in drug developments. Currently, he is also a member of Genetic Engineering Appraisal Committee (GEAC), the biotech regulator. Excerpts from the interview: Q What is the purpose behind establishing ICGEB in India? Prior to establishment of the Asian Chapter of ICGEB, several proposals were sent to headquarters at Trieste. Among those, the Indian proposal for establishing a center in New Delhi was found to be the most competitive one. Therefore, it was decided to establish a center in New Delhi. With support from Indian and Italian governments, the ICGEB was initially housed at National Institute of Immunology (NII), but was later shifted to the present campus of 10,000 sq.ft.area. I would also like to mention that the former Prime Minister of India, Indira Gandhi, played a big role in establishment of the institute, and was instrumental in its foundation in India. The purpose behind the establishment of ICGEB was to provide a scientific and educational environment of the highest standard, and conduct innovative research in life sciences, for the benefit of developing countries. The center strengthens the research capability of its members through training and funding programs and advisory services; and represents a comprehensive approach to promoting biotechnology, internationally. Q What major research activities are given top priority at ICGEB? We have eight major focus areas including the main research areas of mammalian and plant biology. Biomedical projects are pursued in virology (hepatitis B and E viruses, human immunodeficiency virus and severe acute respiratory syndrome (SARS) virus); immunology (biology of the immune response and tuberculosis), development of diagnostics and vaccine candidates for dengue viral infection and structural biology (development of synthetic antibiotics, crystal structure determination of proteins and polypeptides) and in the field of malaria; both in basic research, and vaccine and drug development, as well as development of technologies for biopharmaceuticals, and for diagnosis of infectious diseases. In the plant biology area, research projects address the study of insect resistance and biopesticidals, abiotic and biotic plant stresses and crop improvement through biotransformation. ICGEB is also making a unique headway in anti-dengue research. Dengue vaccine program is in progress and since it has got a long hibernation period, it is expected to take more time. In case of dengue, it might take a year-and-a-half to substantiate. Q How is the progress on the TB drug development front and malarial research? The progress on the Gates Foundation-funded research on TB and malaria, has been very positive so far; but the rest of the funding would be granted only after the evaluation by the Gates Foundation. We are highly hopeful of that, otherwise, we would have to look for some industrial partner for the support to continue the research. The phase-I trials for our malaria vaccine will begin soon; because it took a long time to get approvals from the Drugs Controller General of India (DCGI), as their approach is very cautious. Since we have a very good facility for TB and malaria research, we are looking forward to more industry collaborations. We have, in the past, partnered with many companies for technology transfer in malarial research. I think we have the required skills to translate the ideas into products. We are in negotiation with a few companies for the TB drug, and would be announcing the same within three months time. Moreover, a recent study undertaken by the Immunology Group at ICGEB, in collaboration with the All India Institute of Medical Science (AIIMS), focuses on new pathways for TB therapy. The findings, published in the journal, Cell, explains the way the TB bacterium survives inside the human body. The results could be used to create a TB therapy that is not antibiotics-based, and could be a valuable tool in the fight against antibiotic-resistant TB. Q How do you evaluate your experiences in working with the industry ? When we began in 1988, we came up with many new technologies. We developed many diagnostic kits in the past, and collaborated with industry for technology transfer. But, somehow I feel that we didn't get a better deal out of that. However, I don't blame any of our industrial partners, as it was our own lack of awareness about intellectual property rights (IPR) that has to be blamed for it. Despite having the access to technology, the lack of trained manpower and sufficient knowledge about handling technology made us apprehensive about it. Q Although we started late, we have been quick to adopt the same. But, now I am happy to see the initial hiccups are tackled and we have come a long way. How do you plan to bridge the gap between basic and translational research? We try to find the balance between the basic and translation research. However, it is not feasible for us to get into translational model, as we are involved in doing the basic research. Therefore, we are in need of a translational facilitator that can help to translate the basic research into the product outcome. Q What are your views on the  patent rights in the current context ? The lack of awareness about the IPR has been a very bad experience for public institutes. This has led to many situations where despite having the authority over the product, we could not ask more from our industrial partner because of the papers signed under contract. Ideally, if a scientist is producing some new product, he cannot be the owner, because of the fact that he utilizes the public funding for the research. Therefore, I feel that the product created by the utilization of public funds is the property of institute, and should not be owned by an individual. Q What kind of funding is received by the ICGEB ? We have received `14.07 crore ($3 million) from the Bill & Melinda Gates Foundation for the initial research focused on malaria and TB drug development. The Indian government has provided core funding. The Department of Biotechnology (DBT) gave us many projects, and we have been allowed to write proposals to put our focus on Indian issues pertaining to agriculture (drought resistant rice), and cotton research. The DBT has helped us, and the Wellcome Trust has supported us in many ways. Italian and Indian governments committed funds; and the United Nations (UN) agreed to provide the logistics support. The role of the UN is also administrative in nature, and we don't get any financial support from them. Q What are the initiatives taken by ICGEB to strengthen ties with its members? ICGEB plays a crucial role in encouraging talent across member countries to promote research in core areas. We select students from the member-countries and their expenses are borne by ICGEB. In total, there are 60 members who contribute funding to ICGEB, but those contributions are almost negligible. Q What is the role played by ICGEB on biosafety front? ICGEB plays an important role in biosafety-related issues, and in the environmentally sustainable use of biotechnology. In biosafety-related issues, we need to have our own system and cannot follow Europe blindly. We do have perception issues in India, and people sometimes get too apprehensive, which is not a good thing. I agree that we have to be very cautious as it is directly related to our health; but the concerns according to me should be genuine. Q Since you have been a member of GEAC, what is your opinion on the Bt brinjal issue? As the moratorium continues, I would not like to comment on this. However, I would like to add that we need to deliberate to arrive at a decision whether to use Bt or not, because otherwise the other crops in the trials would meet the same fate. At the 100th meeting of GEAC, it was decided that a panel of prominent and expert scientists be formed, to decide on the further biosafety tests to be conducted on the Bt brinjal. Rahul Koul in New Delhi ]]> <![CDATA['Trust crucial for global business']]> https://biospectrumindia.com/news/95/2110/trust-crucial-for-global-business.html https://biospectrumindia.com/news/95/2110/trust-crucial-for-global-business.html Wed, 08 Sep 2010 12:44:00 +0530 Dr B Sahu, chief executive officer and president, Innovassynth Technologies, Maharashtra Dr B Sahu has been the chief executive officer and president of Innovassynth Technologies since 2002. A graduate in science, with  post-graduation, Dr Sahu completed a PhD in management. He has over 30 years of experience in various industries. He has been involved in starting a software company as well Innovassynth has been involved in the contract research industry since 2002. Our strategy is to have a knowledge-based, R&D-driven, chemical/biotech service company. The whole idea of categorizing Innovassynth as a service company is to focus on cost, quality, timely delivery and right communication with the clients, which are the milestones of success of any CRO. Despite significant increase in R&D investment, the number of new molecular entities (NMEA) and biological license applications (BLAS) filed in the US and Europe, has decreased over several years. This has led to cost-cutting for R&D, and cut-off time for drug development. Hence both India and China have become a major center of focus. Innovassynth is involved in developing building blocks for RNA and DNA with eight drug discovery companies and three pharma companies, in the US and Europe. Also, Innovassynth is involved in developing special molecules, scale up and producing large quantities. The best opportunity for India is to work in high-end chemistry. While working in this new area of technology, innovation is a must. Fostering the culture of innovation is a great challenge. This calls for flexibility, risk taking behavior, informal work culture and freedom to express new ideas and encouragement for experimentation. Most of the conventional Indian organizations are not equipped with this . Determination and perseverance of top management is critical for achieving success in CRO industry. Since the business is very dynamic, dealing with international clients, and winning them over is not that easy. Even if the client works with you once, it is very essential to maintain a good relationship, and produce ideas/results exceeding their expectations, to ensure long-term bonding. Transparency in communication and effective communication with the clients are the key milestones for trust building. The clients must be updated on their projects, online. In addition, they should have direct access even with the junior-most scientists working on the project. It calls for developing great maturity of scientists to respond and communicate with the international clientele. Time, cost and quality are the essence of this business. Hence supply chain is also a major function, where getting raw materials in time, and shipping the finished product to various countries following international norms are the key factors in addition to quick development of molecules, scale up and its manufacturing. IPR, confidentiality and quality management system are also a must. We, at Innovassynth during the past eight years, have cultivated and won over more than 45 international clients. Our work focus with some of them is on leading-edge chemistry. Many times, we have worked with a concept and broad ideas, and have delivered the product ahead of schedule. In fact, in India, there is a great business opportunity to work in high-end technological areas and compete in the global market. ]]> <![CDATA[Trial volunteers are aware of process]]> https://biospectrumindia.com/news/95/5291/trial-volunteers-are-aware-of-process.html https://biospectrumindia.com/news/95/5291/trial-volunteers-are-aware-of-process.html Wed, 08 Sep 2010 12:41:00 +0530 Dr Saurendra Das, country head and executive director of operations, Excel Life Sciences, Uttar Pradesh Dr Saurendra Das has over 12 years of experience in coordination of all phases of global and domestic clinical trials. Prior to joining Excel Life Sciences, Dr Das was responsible for establishing two major site management organizations (SMOs), and one clinical research organization (CRO) in India. He has led large clinical operations teams and brought many innovations to the field, including strategies, systems and processes, for faster enrollment and increased retention. As an active trainer, he worked closely with faculties from the Harvard Medical International for developing a global training program, and has personally trained hundreds of pharma, CRO, SMO, central lab and site employees. Dr Das has worked as faculty for the Central Drug Standard Control Organization (CDSCO), World Health Organization (WHO) and Institute of Clinical Research India (ICRI) It is well-known that India is a region where clinical research is on the rise. India has several advantages to its credit that include huge population of treatment-näive patients and cost-efficient clinical trials. It is rightly estimated that by 2010, the clinical research market in India will reach 2,344-2,812 crore ($500-600 mn). That growth brought a tremendous amount of regulatory restriction and safety measures to protect the rights of patients. It has also attracted a tremendous amount of scrutiny and negative media coverage. However, not much information has been publicized regarding Indian patient’s knowledge and understanding of clinical research and their experiences, especially with the informed consent process. Excel Life Sciences has recently conducted a survey of over 900 study participants. This research brief analyzes the findings of the study, and includes comparisons of the findings with the study conducted on US patients by CenterWatch. This is also the first such survey to be made public. Findings of the study About 97.7 percent patients who participated in the survey understood the informed consent form (70 percent very well, 27 percent well). About 99 percent of patients came to know about the clinical study through a physician, as against just 23 percent in the US. Only nine percent of patients in India made the decision to participate on their own, as compared to 38 percent in the US. About 63 percent of patients were not aware of clinical research prior to participating in a study. Research methodology The research brief comprises of proprietary data collected from the 2009 informed consent survey of Indian study volunteers, and data from a 2005 US patient survey, conducted by CenterWatch and publicized at the 2006 DIA Annual Meeting. Excel Life Sciences collected the survey data through clinical research coordinators supporting studies at active clinical research sites. Data was collected from July 2008, and the survey is ongoing. Observations and conclusions Better understanding: Considering that India is still a nascent market for clinical research, it is surprising to find that over 40 percent of the patients in the survey, had some understanding about clinical research trials prior to participating. Overall, patients seemed to have a strong understanding of what was required of them in a study and the risks involved in it. In general, the vast majority of patients, some 97 percent, understood the informed consent document (70 percent very well, 27 percent somewhat well). Specifically, patients had a strong understanding of the following: About 98 percent understood the number of times they would have to visit the site. About 95 percent understood that the study would carry risks and discomforts. Traditional health information sources: The advent and expansion of the internet, along with the litigious healthcare environment in the US, has caused many patients to pursue a variety of information sources to make educated healthcare decisions. In fact, US surveys have found that more than 60 percent of volunteers go outside of their managed-care setting to self-refer into clinical trials. The Excel Life Sciences survey has found there is a much more traditional information system in place in India, where patients still turn to their physicians for information about their health. In total, 97 percent of patients in the Excel Life Sciences survey, first learned about the study through a physician, including primary care (76 percent) or another physician (21 percent). Strength of decision support system: According to survey findings, there is both a cultural and operational support system in place in India, to assist patients with informed decision making: Culturally, the role of the family and trust in their primary care physician, play a very important role in a patient’s decision to participate. Most patients travel with loved ones to visit doctor, and the same is true for their clinical trial visits. Only nine percent of volunteers made the decision to participate in the trial, by themselves. Operationally, the sites involved in the survey had a dedicated, highly-trained clinical research coordinator working at the study site, assisting busy physicians with running the trial, and helping to answer questions patients or their loved ones have, about the study and informed consent form. When considering this support system in India, it is interesting to note that Excel Life Sciences has found that the average study retention rates are in the low-to-mid-90th percentile. Higher retention rates allow studies to finish sooner, and help reduce study costs and speed the development of new compounds. ]]> <![CDATA[ICS: A new way to manage data]]> https://biospectrumindia.com/news/95/5996/ics-a-new-way-to-manage-data.html https://biospectrumindia.com/news/95/5996/ics-a-new-way-to-manage-data.html Wed, 08 Sep 2010 12:38:00 +0530 Nidhi Saxena, founder and CEO, Karmic Lifesciences, Maharashtra Nidhi Saxena is the founder and chief executive officer of Karmic Lifesciences. She founded the company in 2005, and has forayed into key verticals including oncology, neurology and medical devices. She has been involved in pre-clinical/clinical strategy development and execution of over 50 global and local trials, across multiple therapeutic areas, and has consulted several global pharmaceutical corporations on their product development and commercialization strategies. On the clinical data management (CDM) side, she initiated and developed KarmaData 2.0, a Karmic proprietary CDM software, which was used for several large phase IV studies, and is currently designing Kclinion, a state-of-the-art EDC software for Indian site conditions. As the number of clinical trials increases worldwide, the clinical back office, with its growing complexity and costs, presents a formidable challenge. With ever-increasing volumes of data, a single, fully-integrated clinical system (ICS) is required to encompass the entire clinical workflow and unify multiple stand-alone systems into one. It is time to let some real innovation seep in, and leverage technology to seamlessly capture and integrate data from multiple mediums, in a common portable format, ensure compliance and data integrity leveraging bio-metric recognition technology, and provide real-time data analysis, auto-adaptive design and predictive functionalities. The last two decades have seen a huge growth in the clinical trial industry. As the industry itself is coming of age, and the clinical back office is evolving, there has been no quantum innovation in the way the clinical data is captured, analyzed and reported. While a lot of hue and cry is being made out of the 21 CFR Part 11 guidelines for computerized systems, this is a basic set of guidelines, and does not provide a benchmark for a truly-evolved clinical back office system. Also, while there has been a definite movement from paper-based data capture to electronic data capture, this cannot be termed as real ‘innovation’. Hence, it is time to re-think the entire clinical data management approach and deliver something truly innovative. Challenges of clinical back office As the number of clinical trials increases worldwide, and the volume of clinical data to be managed grows exponentially, the clinical back office presents a formidable set of challenges. First and foremost, there are multiple disparate systems to handle different aspects of the trial. You have clinical data management system (CDMS) to handle paper CRFs; electronic data capture (EDC) to handle web-based electronic data capture; clinical trial management system (CTMS) to handle trial-related metrics and reporting; integrated voice response system (IVRS) to manage investigational supplies; SAS to handle data analysis; pharmacovigilance systems to manage safety reporting and CTD/eCTD to handle the regulatory submissions process. Each of these systems represent a huge cost to the enterprise, and involve extensive implementation, customization and validation activities, as well as high ongoing maintenance costs. Further, there are several issues in ensuring compliance.While all systems are technically using the Clinical Data Interchange Standards Consortium (CDISC) standards, there are several challenges with data portability from one system to another, and systems integration can be a complex exercise depending on the varying technology platforms, data and table structures. Importance of ICS There is clearly a need for a single integrated clinical system (ICS) to handle the entire clinical workflow, from database design to regulatory submission. Such a system should integrate all functionalities of the existing disparate systems, and bring them under a common database and table structure, with unified data views and reporting dashboards. This will bring down the overall IT investment as well as provide a seamless, fully-compliant method of data management. But the question is – what else can be done to create a truly-evolved data management system? Futuristic clinical technology Besides what the current systems provide in terms of robust document management and workflow capabilities, electronic signatures, roles-based access and audit trials, when one thinks of a truly-innovative clinical system, he/she visualizes a futuristic, seamless and fully-integrated system that would provide the following key functionalities: Multiple data capture channels and electronic data: The ICS would be able to accept data from multiple data capture channels including paper, fax, e-mail, electronic Case Report Form (eCRF), EDC, personal digital assistant (PDA) devices, bluetooth-enabled medical and diagnostic devices, and integrated multiple file formats such as document files, image files, medical scans, X-rays, into common file formats as envisioned by the Health Level Seven International (HL7) standard. Biometric recognition: In order to address concerns about patient record and data integrity, the system would be able to integrate biometrics recognition technology and link all patient data to biometric scans such as finger-print recognition, retinal recognition, and face recognition. Real-time analytics: In clinical trials, it is all about data-driven decisions. Often, the interim and final analysis related to trial data, take several weeks to complete and provide results, when it is too late to make any changes to the trial design. A system that analyzes data on a real-time basis while maintaining the data blinding can be of immense utility, wherein an unblinding algorithm can be applied to get the interim trial results quickly, and thereby adapt to the trial design as necessary. Auto-adaptive/predictive capabilities: Drawing from the previous point, an advanced clinical system would have robust auto-adaptive and predictive capabilities, wherein, as the data gets analyzed on a real-time basis, the system would automatically suggest an adaptive go-forward trial design, and have the intelligence to provide predictive outcomes, at any time during the trial based on the existing interim data analysis. Platform agnostic: The system would use open source technology, and would be completely platform agnostic, wherein, data could be extracted from any system in any format, and plugged seamlessly into the ICS. The new workflow For the system functionalities, the following envisages how the data workflow would get modified in the new system, and how data would be captured in the integrated clinical system: Step 1: All patient-objective medical parameters would be captured via bluetooth-enabled medical and diagnostic devices, directly onto a remote server. This would substantially obliterate the need for source data verification, and reduce chances of data tampering dramatically. Step 2: All patient-subjective parameters including assessment scales, quality of life (QoL), global patient and physician questionnaires, would be captured using 21 CFR Part 11 compliant, hand-held PDA devices. Step 3: All patient lab data would be directly uploaded onto the remote server using a web-based lab interface. Similarly, all safety and pharmacovigilance data would be uploaded on a real-time basis onto the remote server using a web-based interface. Step 4: As the system keeps receiving data from multiple sources and in multiple formats, it will keep decoding the data and creating unified patient records in a pre-defined tabular format, that can be made available on a real-time basis. Step 5: The system would further keep analyzing the data on a real-time basis and interim results at any point in the trial would be available at the click of a mouse. Step 6: The system would further generate auto-adaptive trial design and predictive models of the trial results using pre-defined algorithms thereby enabling researchers to make real-time changes to the trial. Step 7: A regulatory interface would further communicate real-time trial results to regulatory agencies and keep pushing updated data files onto the regulatory server if so desired. All these files would get auto-compiled to create a CTD file. Thus, the system would provide a fully-integrated workflow from start-to-finish of the study. The integrated clinical system is the need of the hour for the pharma and clinical trial industry, and is an innovation worth pursuing. It may change the way we view data, forever. ]]> <![CDATA[Critical aspects for clinical trials]]> https://biospectrumindia.com/news/95/2715/critical-aspects-for-clinical-trials.html https://biospectrumindia.com/news/95/2715/critical-aspects-for-clinical-trials.html Wed, 08 Sep 2010 12:36:00 +0530 Dr Sanjeev K Chaudhry, CEO, Super Religare Laboratories, New Delhi Dr Sanjeev K Chaudhry is presently the chief executive officer of Super Religare Laboratories; director of Religare Wellness; and chairman of CSC Nutrigenomics, Singapore. He was the South Asia Head of Solae, a joint venture of DuPont and Bunge, for 11 years, until June 2006. In 1989, Dr Chaudhry, at 30 years of age, became the youngest CEO of a public service company (PSC) in India. He earned accolades for turning around the ailing state-owned Modern Food Industries. He presented the privatization plan of India’s first state-owned enterprise to the Planning Commission. With increasing emphasis on treatments that can improve and prolong human life, pharmaceutical companies are under continued pressure to provide enhanced and newer therapies. This has led to an explosive growth in new drug research. The areas that have seen the largest growth include emerging markets such as India, Asia Pacific, parts of Eastern Europe, Africa and Latin America. The increased number of clinical trials in trial-näive countries is posing significant challenges to regulators all over the world. To overcome these challenges, regulators in the US (US FDA), European Union and Japan are putting considerable emphasis on: Validation of scientific methodologies to verify if the study will yield reliable and interpretative results Selection of patients through a robust informed consent process Strict adherence to inclusion and exclusion criteria as defined in the trial protocol Continuous monitoring of safety data Analysis of any adverse events and/or serious adverse events to balance risks and benefits of the trial Adherence to International Conference on Harmonization-Good Clinical Practice (ICH-GCP) guidelines The central laboratory services provide the crucial infrastructure and support to the pharmaceutical industry to address these critical issues. Selecting a reliable central laboratory provides consistent quality, complete, secure, timely and retrievable data and accurate reporting. A  central testing laboratory provides support functions like data management, information technology, project management, operations, logistics, kit assembling, quality assurance, accessioning and materials. Accreditations such as college of american pathologists (CAP) and national accreditation board for testing and calibration laboratories (NABL) ensure technical competence of the staff, instrumentation, methodologies, documentation, and also endorse quality framework and its management systems that need to be followed to perform and report reliable and clean results. It is absolutely critical to have a reliable central laboratory, as this will set the trend for inclusion/exclusion criteria, unbiased and blinded reporting, customized database, confidentiality of data, subject protection and finally, the future of the drug under evaluation. Key differentiators that a central laboratory brings on table Reliable testing and calibration services Reliable delivery of accurate and timely data Test design and statistical validity Primary instruments as well as the backup instruments/methodologies in place, that ensure business continuity and reliability Setting up and validation of protocol-specific laboratory assessments, or conduct method transfer and validations Flexible reporting options in terms of conventional and SI units, flagging of critical alerts, deltas, trend analysis Support to extensive menu of safety and specialized clinical testing Seasoned and GCP-trained operations staff, ensure business continuity and safety compliance Support to a wide range of therapeutic areas ]]> <![CDATA[Target discovery: A key factor]]> https://biospectrumindia.com/news/95/7051/target-discovery-a-key-factor.html https://biospectrumindia.com/news/95/7051/target-discovery-a-key-factor.html Wed, 08 Sep 2010 12:35:00 +0530 Sanjay Bettadpura, Chief Business Officer, Polyclone Bioservices, Karnataka Sanjay Bettadpura is currently chief business officer of Polyclone Bioservices. He has over 12 years of experience in business development and international marketing in the life sciences and IT industries across the US, Europe, APAC and India. Bettadpura’s previous roles include, start-up and market expansion of North American division of an Indian bioinformatics company in Connecticut, US; setting up of life sciences division of a knowledge management consulting company in Mumbai; and driving the sales of a software network management solutions provider in Bangalore and Singapore. As an early stage biology-driven research partner to the drug discovery industry, Polyclone specializes in target discovery and validation services with a focus on cancer and infectious diseases. Our customers include biopharma and diagnostics innovators, developers of high throughput research platforms and oligo and reagent companies. We enable them to achieve their biology research goals by synergistically combining silico and in-vitro approaches, thus giving direction to their research and development pipeline. Being in this niche and a highly IP sensitive field, we face several challenges spanning commercial, confidentiality and scientific facets that we overcome through a combination of strategies. Target discovery, being the first step in the drug development process, determines the fate of all the next phases and investment. Given its critical nature, the field is replete with several pitfalls and complexities. In cancer, it is particularly tricky to identify druggable targets owing to the complexity of the disease’s origin and its molecular biology. In infectious diseases, the challenge of mutating viral targets (as in the H1N1 and other influenzas) makes finding a target seem impossible. Added to these are the generic challenges of making sense of the tera bytes of genomic data, linking genotype-phenotype profiles and the implausibility of using humans for studies. Increasingly, the drug industry is realizing the specialized nature of target research and the need to decouple it from in-house R&D. It is no wonder that 80 percent of the validated targets identified in the last nine years, are through smaller biotechs and research alliances. As a small biotech/research partner, the key challenge for us is to break the myth that it is too early to outsource research at this stage. We need to convince prospects that outsourcing is possible, and we also need to make them understand that it is even more critical, especially at the early stage. According to the Wall Street Journal, several big pharma–small biotech deals in the recent past highlight this growing trend and early-stage and preclinical biotech deals are getting sweeter. The early stage deals in 2009 was 68 percent higher than the year before while, the jump for phase II was a modest 39 percent. This is a clear indication that pharma companies are willing to take risk at an early stage, when it is easy to write-off any experimental products that don’t bring positive results in trials. Closing the deal is only the beginning of the relationship and it takes commitment from both sides to ensure its progress and success. At Polyclone, we work with our partners as a true extension to their team, and offer them the required seamlessness and easy interaction, while ensuring that we provide the scientific insights and nimbleness that the partner requires. Since this is still the research-intensive conceptualization stage, it is important to have an open and interactive relationship, that fosters creativity and exchange of knowledge points. The success factor here is to ensure that we treat the project not just as a contractual obligation, but as a discovery project guided by specific timelines and objectives. This is a challenge many a time, since there may be no definitive result or the customer’s hypothesis may not be working out. It is important to continually keep the customer updated about our approach and progress, while warming them up to the possible outcomes – positive or not-so-positive. This is imperative when we work on in-silico aspects like assay design, structural simulation, drug receptor interaction modeling and data analysis. In-silico approaches provide huge cost savings and provide perspectives that may not otherwise be gained, in vitro validation is critical to ascertain the findings and revert to the drawing board, if required. At Polyclone we intersperse the in silico work with DNA/RNA and cell-based validation on sample data, to ensure biological relevance and thoroughness. This multi-disciplinary approach that synergizes computational, molecular and cell biology, combined with our access to patient samples and data, gives us the holistic edge that our customers profit from. Since most projects that we pursue are novel and diverse, we need to be continually abreast of science, skills and technology at a global level. After all, if we are working with innovators, we need to be one step ahead, to be of true value to them. What we discover or validate may often have no precedent or references, and it is the thoroughness of our data and validation, that provides our customers the confidence to take a decision on the next phase. The other challenges that come up are common to CROs across all phases – ensuring and convincing customers of IP confidentiality, guaranteeing ethical compliance, and providing commercial and innovation value that customers seek from Indian companies. The mantra is to innovate better, faster and cheaper and make no compromises in the process! ]]> <![CDATA[Publication policy is a must]]> https://biospectrumindia.com/news/95/1882/publication-policy-is-a-must.html https://biospectrumindia.com/news/95/1882/publication-policy-is-a-must.html Wed, 08 Sep 2010 12:33:00 +0530 Arun Sundriyal, head of clinical management, PPD, New Delhi Arun Sundriyal is head of clinical management for PPD in India. He holds a post-graduation in pharmaceutical biotechnology. Sundriyal has more than nine years of experience in clinical research and has worked in vast therapeutic areas such as oncology, neurology, dermatology and respiratory endocrinology. Today, India is poised as a preferred location for conducting global clinical trials due to the inherent advantages of cost, speed and quality associated with the overall development of a drug. India’s success is evident by the sheer numbers of clinical trials happening in the country, which is projected to reach 15 percent of all global clinical trials over the next five years. India’s total clinical trials market is estimated to reach 9,347 crore ($2 billion) by 2012, and pharmaceutical companies are outsourcing much of this work to contract research organizations. CROs are fast gaining importance because of their global presence, specialized local and therapeutic expertise, and competitive pricing strategies. A significant number of new CROs have established operations in India over the past few years, and many pharmaceutical and biotech companies are viewing CROs as strategic partners. Though guidelines for conducting global clinical trials remains uniform (ICH-GCP guidelines), interpretation of these guidelines changes to comply with applicable regulatory requirements in a given country. These changes pose great challenges for CROs. Since a CRO customizes its operations based on a sponsor’s specific requirements, it must account for cultural and procedural differences. There are many challenges for CROs in India: 1. Variable standard operating procedures In the absence of uniform standard operating procedures (SOPs) across companies, various working procedures change from company to company. It becomes particularly difficult when there are different procedures required by different sponsors for CROs working with the same investigator on the same activity. For example, considering the procedure of Informed Consent Form (ICF) administration, some sponsors require only an impartial witness to sign the document, if a study subject is unable to sign by himself/herself, yet other sponsors may require a legally acceptable representative, to sign the ICF document on behalf of the study subject. In addition, various documentation requirements for critical trial activities vary among sponsors. Requirement changes may create confusion for investigator site personnel, leading to more deviations. When questioned on variable SOPs by site personnel, CROs must base their response on the sponsor’s requirements. Investigator sites often fail to understand why there is a non-uniform interpretation of so-called uniform guidelines. 2.Contractual obligations and answerability The clinical trial agreement (CTA), which is executed between a trial sponsor and investigator site, is another element that creates difficulties for CROs. While in some cases a CRO is considered a party to the CTA, in a majority of  the cases agreements are executed only between the sponsor and the site. Hence, most of the time, a CRO does not have control over contractual obligations set forth between the sponsor and trial site. However, the CRO is held fully-accountable on contractual obligations by both sponsors and investigator sites. Whether it is schedule of payments or utilization of study/administrative grant, a CRO may be in a difficult position to maintain agreement between the sponsor and investigator site. 3. Publication policy This area is the most common element of disagreement between investigator sites and CROs. There is no publication policy in a majority of trials. In the absence of a clearly defined policy, a CRO struggles to address this issue effectively with investigator sites. Though the authorship in a trial publication is directly linked to the contribution made by an investigator, there have been instances where Indian investigators have been excluded from providing authorship in spite of being among the highest recruiters for patients worldwide. 4. Inexperienced CROs The growth in the clinical research industry has led to the operation of CROs that do not have a serious understanding of clinical research. Many of them are set-up for short-term gains rather than being a long-term partner in developing this sector in the country. Often these organizations do not have sufficient well-trained, qualified employees and lack the processes, systems and infrastructure to conduct quality global trials. 5. Development of new investigator sites Sponsors often prefer to work with investigator sites that can devote time to its study and that are not already participating in too many clinical trials. With the sudden rise in the number of clinical trials being conducted in India, most trained investigator sites have been saturated with multiple studies, which are creating quality issues. CROs, like sponsors, want to work with sites that have prior clinical trial experience. It is a challenge for CROs to identify trained sites that are not currently participating in many studies. As an alternative, CROs need to identify new investigator sites and train staff on international guidelines and procedures to ensure quality in conducting clinical trials. Scaling of new investigator sites toward global clinical research, requires investment of additional time and efforts by the CROs. India continues to be a competitive place for conducting trials and to ensure that quality training takes place, CROs need to assume additional investments at their own cost. 6. Archival of study documents After the completion of a clinical trial, there is a requirement for archiving study documents for a specified period of time. This time frame varies from 10 to 20 years across the industry. Since CROs often approach investigator sites on behalf of multiple sponsors, they are under pressure to provide the archival facility/space. This issue may lead to delays in initiating new trials, therefore CROs must often work out alternate archival arrangements for the trial sites, at their own cost. 7. Attrition rate and trained staff High turnover rates in the rapidly growing Indian clinical research industry are posing a challenge for CROs. To retain employees, CROs must offer competitive compensation packages while ensuring projects are properly resourced. Currently, there is a shortage of approximately 50,000 trained personnel in India’s clinical research industry. A key success factor of any clinical trial depends on how well an investigator has assumed his/her role, therefore, it is important that other sponsors and CROs develop a consistent and collaborative working environment with investigators. Whether it requires bringing harmony in operating procedures, or a uniform interpretation of regulatory guidelines; initiatives taken by sponsors and CROs will go a long way to ensure the successful execution of global clinical trials in India. Recent initiatives led by the Drug Information Association aim to bring uniformity in the taxonomy of trial files to the industry for uniform documentation practices. Some of the sites have started electronic archival of study documents, but validation of the archival process as per CFR Part 11 is still a challenge. The Drug Controller General of India has taken some initiatives like CRO registration, that is still in draft stage. A similar initiative for bringing uniformity in working procedures seems warranted. For India to remain a key to the global clinical trials market, pharmaceutical companies, CROs and investigator sites need to work together closely, to address these challenges, which will bring greater quality and efficiency to conducting global research in the country. ]]> <![CDATA[CRO: Evolution and challenges]]> https://biospectrumindia.com/news/95/2333/cro-evolution-and-challenges.html https://biospectrumindia.com/news/95/2333/cro-evolution-and-challenges.html Wed, 08 Sep 2010 12:31:00 +0530 Dr Sushil Shah, chairman and founder, Metropolis Healthcare, Maharashtra Dr Sushil Shah is the chairman and founder of Metropolis Healthcare. He has served as the director on the board of Dr Reddy's Laboratories, Hyderabad; and as executive director of two of the group companies; Span Diagnostic and Zydus Cadila. His qualifications include a research fellowship from the Cornell Medical Center, New York, US; a MD in pathology; and he is also a guide to PhD students at Bombay University. Most of today's major pharmaceutical companies with revenues in excess of 14,070 crore ($3 billion) and R&D expenditure in excess of 2,345 crore ($500 mn), were founded in the late 19th and early 20th centuries. These companies have further consolidated over the years, as a result of mergers and acquisitions between pharmaceutical and biotechnology industries of complementary capabilities. As these companies scan for new growth opportunities over the next decade, they find that some of the most promising areas are found in the world's emerging economies. The clinical research industry, today, comprises of service providers catering to various needs of pharmaceutical clients. The basket of services offered include: clinical trial and site management, central laboratory, medical writing, data management and statistical analysis; these industries emerged mostly in the 1990s, due to stiff competition amongst manufacturers, to reduce drug development-to-market time in rapidly growing therapeutic areas. Industry analyzers such as IMS Health and BCC Research, estimate the global pharmaceutical market to be worth over 4,692,755 crore ($1 trillion) by 2013. Status of emerging economies McKinsey's India Pharma 2015 report estimates the Indian pharmaceutical market size at 93,853.40 crore ($20 billion) by 2015, as compared to 29,566 crore ($6.3 billion) in 2005. Major drivers of such enormous change encompass both economic and service factors. While McKinsey's analysis sees doubling disposable incomes, expansion of medical infrastructure and greater penetration of health insurance, as reasons for the changing economic scenario, our exposure in the industry as a clinical research service provider, sees the increasing number of trained good clinical practice (GCP) sites, successful completion of US FDA audits, extensive use of English as the medium of communication, and good information technology infrastructure enabling electronic data capture (EDC) and telemedicine studies, as major service factors affecting the above growth. According to US government's clinical trials registry, out of 93,860 registered clinical trials in the world, in August 2010, South Asian countries have 1566 registered trials â€“ with India alone accounting for 87 percent. Hence it has been predicted that countries like China, Taiwan, South Korea, Singapore, Thailand and India will play a crucial role in determining drug development to market time in the coming decade. Clinical Research in India India, in particular, is expected to play a crucial role according to McKinsey, due to the growing prevalence of lifestyle disorders similar to those in developed countries. Statistics reveal that the prevalence of diabetes in India will rise from 2.8 percent in 2005 to 3.7 percent in 2015, cardiac disorders from 3.3 to 4.9 percent, obesity from 1.3 to 2.7 percent, and the hypertensive population to hit five crore over the next decade. This projection correlates with Sanofi-Aventis' initiative to conduct a study, to ascertain the prevalence of diabetes and hypertension, titled 'SITE-Screening India's Twin Epidemics in 2009-10'. Challenges ahead With India rapidly acquiring center stage in the clinical research industry, service providers are faced with several challenges. A decade ago these challenges could broadly be classified as regulatory, educational and ethical. Regulatory issues were mainly due to the lack of provision in drug laws for global studies, high import duty, no data exclusivity and long start-up times. These have been resolved to a certain extent by several initiatives by the Indian government, like not levying import duty on clinical trial supplies, allowing export of biological specimens, subject to protocol approval, abolishing the one-phase lag requirement in India for multi-national trials, and exempting CROs from service tax for trial-related activities. In addition to these, the Patent Act and IPR are also in place, though these still need to be streamlined as they will determine the future of patented products. Educational challenges are due to the lack of familiarity of the medical community with the concept of clinical trials, absent or low GCP awareness, and limited access to IT infrastructure in medium and small healthcare set-ups. Today, India has its own GCP guidelines for clinical trials that have evolved on the lines of WHO, ICH, US FDA and European GCP. This, along with increasing involvement of private medical practitioners, acting as principal and co-principal investigators, have led to a drastic increase in the number of GCP-trained sites, at least in tier-1 cities, many of which have even successfully completed US FDA audits, with no major non-compliances. Ethical concerns are mainly related to minimal number of institutional review boards (IRBs), with even fewer being US FDA-compliant, lack of SOPs and poor ICF processes. These too have been overcome today, with the establishment of GCP-compliant IRBs at major centers. However, as cited by the present industry experts' accreditation of ethics committees, training of regulators and EC members, scheduled regulatory inspections; and enhancement of the overall regulatory resource pool, are some areas that are yet to be addressed, and improved on. If challenges a decade ago were process-related, today they are operations, analytical and revenue centric. These are the core areas that both service providers and policy-makers need to focus on, in the coming decade, to bring about an overall process improvement in clinical research. Operational challenges are mainly related to site management, where delay in convening IRB meetings, multi-tasking site staff, and overambitious site feasibility response submitted to sponsors delay time lines, leading to huge revenue deficits. This, added to the high attrition of GCP-trained personnel at sites, make timely subject enrollment and site closeouts within predefined budgets, a huge challenge. The way in which these may be addressed are: by forming a consortium of clinical research service providers, regulatory policy-makers and the academia, to debate implementation of penalty clauses for delays at sites, define personnel, is to study ratios and drafting guidelines for verifying site feasibility response, based on past case records. Attrition can be dealt with by creating partnerships with academic institutions for supplying trained resources, and addressing the reasons for attrition, in detail. Analytical issues have not received much coverage in clinical research forums till date, as these mainly involve central laboratory operations, which is still a niche area, having few service providers. Major concerns are sample logistics across tier-II cities, maintaining specimen integrity and turn around time of lab reports, such that they are well within protocol time lines. Steps have already been initiated towards process improvement with key central labs forming the Indian Association of Pathology Laboratories (IAPL), that focus on working with regulatory bodies, to bring about legislation covering accuracy, patient care and safety in clinical diagnostics, collaboration with technical institutions to upgrade skilled manpower, harmonizing results, and reference ranges, in case of decentralized testing and benefiting from global outsourcing opportunities. Revenue-related concerns are currently ambiguity in the service tax act which exempts CROs conducting clinical trials, approved by the Drug Controller General of India (DCGI), and routine diagnostic testing from service tax, but is yet to clarify the status of laboratory medicine services in the ambit of clinical research. This is one area that bodies like the IAPL need to address, in collaboration with our policy-makers. Conclusion: To sum it up, the Indian clinical research industry though fraught with challenges, has already overcome many of them, by making positive inroads into those yet to be addressed in the next decade. This pace can be maintained only by sustained collaborative efforts of the pharmaceutical industry, clinical research service providers, policy-makers and academia for as the English proverb goes-smooth sea never made a skilled mariner. Dr Sushil Shah, chairman, Metropolis Labs, with inputs from Dr Shilpa Puthran ]]> <![CDATA[India: Clinical research hot-spot]]> https://biospectrumindia.com/news/95/1200/india-clinical-research-hot-spot.html https://biospectrumindia.com/news/95/1200/india-clinical-research-hot-spot.html Wed, 08 Sep 2010 12:29:00 +0530 Shiv Raman Dugal, chairman, board of directors, Institute of Clinical Research, New Delhi Shiv Raman Dugal is the chairman of the board of directors at the Institute of Clinical Research (ICRI), the first and the world’s largest institute in clinical research education. He has been responsible for raising the organization’s delivery capability to world-class standards. With over 30 years of experience, Dugal has been a part of the ICRI since its inception in 2003. He is an active member of many industry associations and societies, and has served these bodies in various capacities, in implementing their programs Clinical research industry has been growing exponentially in the past few years. It has opened up a large number of career opportunities to medical, pharma and all interdisciplinary fields. In Asia, the major destinations for clinical research are Singapore and India – estimated to be worth 11,500 crore ($2.5 billion ) by 2010. Currently 2,50,000 positions in clinical research are said to be available worldwide; with 50,000 job openings in India, within next 3-5 years. Singapore is already a hub in the APAC for biopharma firms and contract research organizations (CROs) to conduct their regional clinical development activities. Growth of global clinical research. Clinical research industry has grown around the world at an unparallel rate in the past few years. It has opened up new vistas of employment for a large number of people. Currently, the worldwide clinical research market is worth over 23,920 crore ($52 billion), 70 percent of the business is generated within the US, employing an estimated 210,000 individuals. UK is considered as the hub for clinical trials in Europe with over 70,000 individuals in the industry. Clinical research in India India is increasingly recognized as the most promising hub for global clinical research. The clinical trial outsourced market in India is forecasted to grow at a CAGR of around 31 percent during 2010-12. “Registered clinical trials in India have gone up from 221 in 2007 to around 1,300 in 2009. Eighty Indian hospitals are presently involved in clinical trials. This figure is likely to go up to 14,000; and will mean involvement of five-lakh doctors, seven-lakh beds, 17,000 medical graduates in 160 medical colleges. India is fast emerging as a favored destination for clinical trials in new products by multinational pharmaceutical companies. Two major reasons for its popularity can be attributed as easy access, and availability of a large, diverse and therapy-näive population, with vast gene pool and a lower cost of technical services; resulting into lowest per patient trial cost. According to an analysis done last year by Rabo India Finance, conducting a clinical trial in a low-cost destination such as India, can cost up to 60 percent less than in the US. Cost savings are a significant dream for many pharma companies when deciding to outsource clinical research to countries in emerging markets such as India. Unlike the US, India has favorable government regulations and approval process. Trials and tribulations The challenges India faces for expansion of its clinical research market are: insufficient number of hospital sites and trained personnel meeting  international conference on harmonisation-good clinical practice (ICH-GCP) norms, equipments at hospitals/ sites for conducting trials not always on par with trial sites in western countries, apart from bureaucratic hurdles for regulatory approvals for global clinical trials. Phase I trial is not allowed in India unless the molecule is developed in India, the industry is looking forward to this being allowed. Phase II and III studies take 45 to 90 days to get approval. Also the lack of protection for the data generated in these trials is the matter of concern. There have been concerns over ethical issues in patient recruitment and conduct of trial, along with the lack of sufficient infrastructure for central laboratory services. The key expectations from CRO market are consistent high quality, credibility, reliability, offering a range of services, broad and focused therapeutic expertise, timeliness, global reach local expertise approach and expertise in developing newer drug delivery systems (NDDS) packages. To meet the challenges and address the key issues, India need to devise policies and insure implementation in legislative, IPR structure and regulatory issues. India also needs to help develop CROs with adequate capacity and competency in carrying out clinical research activities in compliance with ICH/GCP guidelines. Clinical research to boost industry. According to McKinsey report, India is emerging ‘as hub for global clinical research’. The global clinical trial outsourcing opportunity in India is estimated to be around Rs 5,000 crore by 2010, and there will be a requirement of approximately 50,000 clinical research professionals. Today, there are more than 2,50,000 positions vacant worldwide. And salaries vary from a minimum of 18.4 lakh ($40,000) per annum for a clinical research coordinator, to almost 4.6 lakh ($10,000) per annum for a business development manager. What this means is that clinical research is definitely the next big career. India, at present, has a requisite of clinical research professionals and personnel in allied services; such as data management, biostatistics and medical welfare. But the current numbers of skilled professionals are only 2,000 and 3,000. The clinical trial market is growing at the rate of 30 percent annually. It takes about 4,600 crore ($1 billion) and some eight to 10 years for a new drug discovery. But if clinical trials were to be conducted in countries like India, the cost could come down to as much as 60 percent. In terms of career, a fresher could get jobs in clinical research segment with a pay packet of about 2.5 lakh annually which eventually goes higher to 5 – 6 lakh annually. Some of the career options available are clinical research associate, clinical research coordinator, clinical data management executive, pharmacovigilance executive, clinical trial analysts, medical writer, drug reviewer and many more. ICRI addresses the need for qualified and trained clinical research professionals by offering various programs in clinical research at its centre of excellence campuses in New Delhi, Mumbai, Ahmedabad, Dehradun, Hyderabad and Bangalore. ICRI is India’s first and only clinical research institute dedicated to promoting ethical research and high-quality clinical research education in India. The courses offered by ICRI are in collaboration with Cranfield University, UK. ICRI is the only institute in India offering courses at multiple campuses throughout the country, thus giving the courses a national character. Quality in clinical research is of paramount importance. Ethical and social considerations should be kept in mind while conducting a clinical trial. All clinical trials performed in the country should meet the specifications laid down in ICH-GCP guidelines. For this our country needs skilled professionals having in-depth knowledge and understanding of the basic principles that are considered as prerequisites for conducting clinical trials. India has various systems of medicines like homeopathy, unani, ayurveda and other traditional systems that offer a wide scope for clinical trials. These practices need to be integrated in traditional products to generate superior knowledge-based products. Future scenario As the drug development is a high-risk investment global pharmaceutical companies under pressure from stakeholders are trying to find ways for cost-containment and to increase the productivity. India with its intellectual powerhouse, patient population, world-class scientific and technical skills and discipline is an attractive destination for global players, for cost and time containment. This is the reason why MNCs are outsourcing clinical research and trials to India. With government initiatives in full swing, a favorable environment is being created not only for the conduct of outsourced clinical research but also for the growth of local pharmaceutical industry at a rapid pace. With full efforts from the government and cooperation from Indian CRO industry to meet the challenges in this field, India is set to become the ‘global hub of clinical research’. ]]> <![CDATA[Value-addition brings opportunity]]> https://biospectrumindia.com/news/95/1610/value-addition-brings-opportunity.html https://biospectrumindia.com/news/95/1610/value-addition-brings-opportunity.html Wed, 08 Sep 2010 12:28:00 +0530 Apurva Shah, Co-founder and Group MD, Veeda Clinical Research, Gujarat Apurva Shah is a co-founder and group managing director of Veeda Clinical Research. He has an MBA in international finance and entrepreneurship from Babson College in Boston, US. Shah has strong entrepreneurial and organizational skills and as the managing director, is responsible for establishing and running Veeda’s India operations. As a member of the board, he gives strategic and financial direction to all group companies. As a trustee of The Ujjain Charitable Trust Hospital and Research Center, he helped setup a medical college and two 500-bed hospitals in central India. He is the chairman of association of CROs in India, since January 2010 for a term of two years. Value-addition brings opportunity Back in 2005 and 2006, a lot of prediction was made that the then `937.40 crore ($200 million) CRO market would scale up to `9,379 crore ($2 billion) by 2010. Needless to say that the target will not be met. The main reason has been the onset of a serious market crisis in the recent global economy, followed by a lack of immediate changes in the regulatory environment, local infrastructure not able to develop fast enough, and lack of expertise in various services. Further, the growth rate for global CROs has also been almost flat for 2008 and 2009. In order to understand some of the reasons for not meeting the predictions, and to be able to make a new revised forecast for 2015, one needs to know what is happening in the global pharmaceutical industry and its impact on the future of CROs, globally and in India. Increased global outsourcing Cost, efficiency and speed of recruitment pushed sponsors to explore new areas for R&D. In the past few years, most of the new markets (other than the US and Western Europe), have delivered good quality data, and hence, it is expected that those CROs will enjoy a more robust growth, as compared to the global growth. In the past few years, the large pharmaceutical companies have lost a lot of talent due to downsizing, and therefore, they will need to outsource more, in future. Only the CROs known to the sponsors and with a clear track-record of performance in the past, will gain a lot of business. Thus, the large ones will become larger. Considering India as a fast growing market for their products, it becomes an added incentive for the sponsors to move more R&D here. Of course, the regulatory and the intellectual property factors will affect the pace of scale up of outsourcing to India. Need to diversify risk of drug development Due to the high cost of getting a drug into the market, there is a need to enter strategic partnerships for sharing the cost and risk of drug development. Considering this concept is not yet well developed, Indian CROs have a chance to establish themselves in this segment. As the liquidity improves in the market, the venture capitalists and other financial investors, would prefer to have their development done in India, to get a better ‘bang for their buck’, and improving the chances of success, by putting more molecules through development, in the same budget. They are expected to have a much more open view of the issue, as compared to large pharmaceutical companies who have their own staff. Growth of generics With a number of patented drugs going off-patent in the coming years, and the pressure to reduce the cost of healthcare, there is a need for pharmaceutical companies to join the bandwagon and start developing generics, in lieu of the drugs going off-patent to maintain revenues and market shares. India is very strong in generic development, and therefore, India will have the opportunity to consolidate its leadership position in this segment, provided we stick to the quality and continue to add more value to the process. Decline in US domination of clinical trials With a number of fragmented players coming up across the globe, and the development of Europe and Asia as favored destinations for clinical trials, the domination of the industry by the US, has reduced from 70 percent to 50 percent, in the recent years. Countries in Eastern Europe and South Asia offer a cost advantage to sponsors and the quality, as per the Food and Drug Administration (FDA) standards. There is an opportunity for India to provide better infrastructure and resources to conduct ethical trials, and generate quality data. Full service CROs/Specialized CROs preferred Sponsors are preferring to partner with CROs that can offer a complete range of services globally, to reduce cost and improve speed and efficiency. Sponsors will always favor CROs with specialty, in any particular therapeutic area or technique or population access, in order to reduce risk of failure and value addition, due to expertise and experience. Indian CROs that possess a global footprint and specialization, will gain the most due to this move. Factors that impact the growth of Indian CROs Past Practices have led to the Current Situation • Increased R&D costs and declining productivity • Rise in regulatory requirements • Fall in pricing and rise of generics • Reduction in healthcare budget and uncertanity in reforms The Future Outlook • Increased global outsourcing • Need to diversify risk of drug development • Growth of generics • Erosion of dominatin of clinical trials by the US • Full service CRO/specialized CRO preferred ]]> <![CDATA[New vistas for CROs]]> https://biospectrumindia.com/news/95/2112/new-vistas-for-cros.html https://biospectrumindia.com/news/95/2112/new-vistas-for-cros.html Wed, 08 Sep 2010 12:26:00 +0530 KV Subramaniam, president and CEO, Reliance Life Sciences, Maharashtra KV Subramaniam is the President and CEO of Reliance Life Sciences. A chemical engineering graduate from Madras University, he has an MBA from the Indian Institute of Management, Ahmedabad, and a Chartered Financial Analyst. In a career spanning 29 years with the Reliance Group and Indian Petrochemicals Corporation, Subramaniam has been responsible for several functions – from corporate business development, corporate planning, project management and economic analysis to marketing; in a wide range of businesses The fortunes of the Indian clinical research organizations (CROs) depend on the global CRO industry, which is dependent on the nature and rate of outsourcing by the global pharmaceutical industry that has been undergoing several domain-specific and structural changes that are creating both opportunities and challenges for CROs. Events such as the economic downturn, pharma mega-mergers and the US healthcare reforms initiatives, have forced stakeholders, especially pharmaceutical companies, to re-align their strategy towards increasing focus on bio-therapeutics as a product class, and producing more safe and cost-effective medicines. This essentially means that CROs having specialized offerings in their repertoire, and the capability to address a broad range of product and therapeutic classes would be better placed to succeed. The Indian CRO industry is dominated by players focused on offering routine drug development services that are primarily non-differentiated in nature. It is important that Indian CROs position themselves to offer specialized high-value services, address broad therapeutic and product areas and differentiate themselves; to compete successfully in the global marketplace. Some of the areas and segments that need particular mention are: specialized human trials to evaluate cardiac safety (QTc studies), radio-labeled mass-balance pharmacokinetic studies, bio-therapeutics drug development and stratified clinical studies based on molecular markers. These areas are gaining prominence, and are important in the drug development context. Inherently, these areas signify new vistas for the CRO industry. In the Indian market, very few players have the capabilities and infrastructure to conduct such studies. Reliance Clinical Research Services (RCRS), the clinical research arm of Reliance Life Sciences, is one of them. RCRS has the necessary infrastructure, linkages and competencies to carry out these specialized studies. RCRS has carried out validation studies in cardiac safety using state-of-the-art systems. It is also in the process of conducting a mass-balance, radio-labeled study. RCRS has conducted several preclinical and clinical studies in bio-therapeutics as also bioassays development, and has demonstrated end-to-end program management capabilities in this segment. In addition, RCRS has completed, and is conducting several clinical research studies for stem-cell therapies, which is another important category in bio-therapeutics. It also has capabilities in carrying out embryo-toxicity based drug screening. RCRS has the ability to leverage the molecular medicine capabilities of Reliance Life Sciences to develop stratified clinical research studies. An important aspect of developing specialized study capabilities is competency development. The Reliance Institute of Life Sciences, a not-for-profit organization, has been conducting one-year Advanced Diploma Programs to address this need. As the global pharmaceutical industry consolidates, the opportunity space for specialized CROs would increase significantly. India has been a destination for clinical research, but there are other countries and regions, such as China, East Europe, Latin America and Africa, that can offer competitive options in clinical research. It would, therefore, be imperative for CROs in India to create differentiated plays to sustain and grow. Indian CROs have to seek out, develop capabilities, and conduct specialized studies, to make a mark in the global clinical research league. ]]> <![CDATA[Clinical research expanding]]> https://biospectrumindia.com/news/95/1493/clinical-research-expanding.html https://biospectrumindia.com/news/95/1493/clinical-research-expanding.html Wed, 08 Sep 2010 12:24:00 +0530 Dr Anand Bidarkar, vice president of business development, SIRO Clinpharm, Maharashtra Dr Anand Bidarkar is the vice president of business development with SIRO Clinpharm. He completed the senior management program from the Indian Institute of Management, Ahmedabad; MBA from SP Jain Institute of Management and Research, Mumbai; and BDS from AME’s Dental College and Hospital, Raichur The growth pace of clinical research in India has been steady, however, it has not attained the rapid expansion that was predicted. There are more than 300 different entities, that have conducted clinical trials in India. These include multinational and Indian biopharmaceutical companies, NGOs and academic medical centers. As per publicly available reliable data sources, the largest number of clinical trials in India were conducted by Pfizer, followed by GSK, Novartis, Eli Lilly and Sanofi-Aventis. Pfizer has conducted nearly a 100 clinical trials in India, and among them, the top five companies account for more than 25 percent of the total clinical studies conducted in India. Reports from publicly available sources of data and information shared at industry forums reveal that the top five companies have internal teams that conduct clinical trials, or in-source clinical research staff from CROs that provide staffing solutions. Many of the trials being conducted by these companies through international CROs in India, might be outsourced at a global level from their head office; hence, while they do a large percentage of clinical research activity in India, their contribution to the growth of the Indian CRO sector is quite limited. Among the academic medical centers conducting clinical research in India, All India Institute of Medical Sciences (AIIMS), New Delhi, tops the list, with around 46 clinical trials; followed by the Tata Memorial Hospital, Mumbai, with 30; and Post Graduate Institute of Medical Education and Research (PGIMER), Chandigarh, with about 20. These figures include only trials listed on the website, clinicaltrials.gov registry, with the institutes as the sponsor. It is quite possible that these institutes might be conducting a number of local trials and also for other companies. Accurate data on the trials conducted by various CROs is not available, even from public sources, or from the Clinical Trial Registry – India (CTRI), as in many instances, the sponsor companies might apply to the Drug Controller General of India (DCGI) for regulatory permission and also register with CTRI. In such cases, the name of the CRO conducting the trial might not be available. However, from the trend of regulatory approvals from DCGI, it appears that Quintiles, SIRO and ICON conduct the most number of clinical trials in India. While Quintiles and ICON are large global CROs with their headquarters in the West, SIRO is an Indian multinational with operations across Europe and Asia Pacific. It is estimated that the top three CROs are currently running around 200 clinical studies in India. The diverse set of organizations conducting clinical trials in India has also meant a large diversity in the therapeutic areas in which clinical trials are being performed. The top five therapeutic areas in which trials are being conducted in India are: • oncology • metabolic disorders including diabetes • infectious diseases including partly respiratory diseases • cardiovascular disorders, and • central nervous system/psychiatric conditions There has been no perceptible change in the phase of trials being conducted in India over the last several years. The continuing regulatory challenges for phase I trials and first-in-man trials in India by non-Indian companies, have meant little or no growth in phase I trials. The majority of phase I trials in India are being conducted by Indian companies with new drug discovery programs. The majority of the trials being conducted continue to be phase II and phase III. As per data presented at the Clinical Trial Forum Thailand, on July 22-23, 2010; of the more than 1,200 studies being conducted in India, over 50 percent of studies are phase III. In fact, India leads China in the number of phase III studies, and is almost at par in the number of cases of phase II studies. The large number of phase IV studies being conducted in China need to be viewed at, from the overall market attractiveness perspective, which is higher in the case of China. It is estimated that the number of phase IV trials in India would also rise, given the entry of new companies and new pharmaceutical compounds into the country. The biopharmaceutical companies conducting clinical trials in India are working on different business models. Most of the large MNC pharmaceutical and biotechnology companies have their offices in India. There is also a large chunk of companies that do not have their presence in India, but their clinical operations are managed either through CROs with an India presence, or in partnership with Indian academic centers or research institutes. The two most common models used in India to carry out clinical research are: setting up in-house clinical research teams or using the services of a CRO. The advantages of setting up in-house clinical research teams are: greater control over the clinical trial conduct, and focused effort on the company’s priorities. On the face of it, this model seems to work well for companies that conduct a large number of clinical trials in India, and are assured of a steady flow of clinical trials from their global offices. Globally, however, the trend of setting up clinical research teams, is being increasingly replaced by partnership with specialist preferred provider CROs. The main reason driving this shift, is that clinical development activity is seldom predictable, and it is a significant burden on the finances of a company, to maintain large teams without activity. The recent mass layoffs in the clinical research teams of several large companies in the US and Europe are indicative of the liabilities of maintaining large teams. As companies focus on cost-rationalization and operational efficiencies, working with efficient CROs can provide significant value. The trend in India among many of the major companies is to have large in-house clinical research teams. This was a good option initially, as there were not many Indian CROs, and multinational CROs did not have presence in India. The global principals of many MNCs did not find the high headcount a challenge, because of the significantly lower salaries, and the low costs of conducting trials in India. This is, however, changing as the clinical research costs in India continue to increase, and Indian offices of global companies are being asked to bring in greater efficiencies in trial conduct. The other factor that has changed significantly is the CRO presence in India. The major national and international CROs have a large operational presence in the country, and unlike before, it is possible to outsource trials. As per industry intelligence gathered from various sources, recently many companies have had limits expansion of in-house teams, and a mid-sized European MNC actually disbanded its entire clinical research team. Smaller and mid-sized companies usually do not venture out to set up in-house clinical research teams, as they are unable to achieve a critical mass of personnel required for conducting studies independently in India. The large, diverse nature of India presents several challenges for the regulatory Institutional Review Board (IRB) and investigator selection. A strong feasibility, regulatory and operational team is essential. The other complicating factor is the high attrition in this sector. Several small companies have failed in their attempt to leverage India’s strengths in clinical research due to this reason. The CRO model in India is emerging rapidly as the preferred alternative to in-house teams. This is as per the global trends and is likely to continue to grow. The main benefits of working with a CRO for small and mid-sized companies include: better investigator reach and follow up. This model also provides access to therapeutic area expertise, which the company might sometimes lack. For larger companies, the CRO model provides greater cost-efficiencies as well as the flexibility to scale up when required. The other advantage is the CROs might transfer their learning from previous studies and other clients, to ensure successful study execution. Whatever be the model, the fact remains that the clinical research scenario in India is at an inflection point, and all stakeholders including the regulators, need to reassess their current strategy in terms of the latest global developments. The number of companies that include India in their clinical development plans is increasing rapidly, for the obvious benefits and to tap the growing market. The growing clinical research industry has brought a significant change for the betterment in medical practice, patient access and patient care at centers taking part in clinical trials. It would be interesting to see if the country evolves as other mature markets have evolved in the past, or charts an altogether new path. ]]> <![CDATA[Phage therapy gains ground due to antibiotic resistance]]> https://biospectrumindia.com/news/95/7705/phage-therapy-gains-ground-due-to-antibiotic-resistance.html https://biospectrumindia.com/news/95/7705/phage-therapy-gains-ground-due-to-antibiotic-resistance.html Wed, 08 Sep 2010 12:07:00 +0530 As a global debate rages on the future of antibiotics due to the presence of yet another â€œsuper bugâ€?, NDM-1 resisting all known antibiotic treatments, the health community is seriously looking at alternate options One of the most promising alternative appears to be the use of bacteriophages, the viruses that kill bacteria, which was used extensively in many parts of the world prior to the discovery of the wonder antibiotic pencillin in the 1920s. The super convenience of penicillin and other antibiotics relegated phages to the background. GangaGen Biotechnologies, founded by a renowned molecular biologist from AstraZeneca 10 years ago to relentlessly pursue phage research, is close to getting the world's first phage-based product ready to tame the deadly bacteria strains stalking patients worldwide. GangaGen is ready to start the human trials of the world's first â€œsuperbugâ€? killer, StaphTAME, a genetically-modified protein developed from phages. StaphTAME, a novel biological drug, using a genetically-modified protein, developed from bacteriophages (the viruses that kill bacteria) by a small Bangalore-based biotech company, GangaGen Biotechnologies, is all set for human clinical trials in India and the US. â€œStaphTAME is a recombinant protein that kills the superbug MRSA (Methicillin Resistant Staphylococcus Aureaus) and all staph bacteria rapidly in minutes by a novel mechanism,â€? disclosed GangaGen founder and well-known molecular biologist, Dr Janakiraman Ramachandran, who has been toiling in the labs for the last decade after retiring as the head of its R&D at AstraZeneca in Bangalore. GangaGen was founded in 2000 with a `9.36 crore ($2 mn) funding from ICF Ventures. MRSA is currently the most serious hospital-acquired infection and as it does not respond to treatments with almost all the known and most powerful antibiotics, it has been termed a â€œsuperbugâ€? out of human control. In fact, because of the untamed nature of the â€œsuperbug,â€? experts have been predicting that the era of antibiotics is over. An alternate method to control harmful bacteria is urgently required. The New Delhi metallo-beta-lactamase (NDM-1) â€œsuperbugâ€? now a cause of concern in the global medical fraternity is one of MRSA strains. StaphTAME is the world's first therapeutic protein developed from bacteriophages to reach the human clinical trials stage. So far, bacteriophage therapy has been used only for treatments after the bacterial infections sets in. â€œAll preclinical development of StaphTAME has been completed and a successful pre-IND meeting with the US regulator, Food and Drug Administration (FDA) has been concluded,â€? Dr Ramachandran shared from the US, as he is preparing for the product's clinical trials in the US and in India. StaphTAME, also called the P128 protein, was developed by researchers at GangaGen's Bangalore (India) and Ottawa (Canada) facilities, based on a key protein from bacteriophage. When the phage, the virus that kills bacteria, first interacts with a bacterial cell, they damage the cell wall in order to insert their genetic material. â€œGangaGen has identified the active portion of the phage molecule that causes this damage, and coupled it with another protein sequence that allows binding to the surface of Staphylococcus,â€? explained Dr Bharati Sriram, a senior researcher at GangaGen. GangaGen has already filed both composition of matter and use patents for StaphTAME and is now vigorously pursuing worldwide patent protection for the product. The P128 protein has been tested against over 200 global strains of S. aureus, more than half of which are methicillin-resistant, and has proved capable of killing all of them, revealed Dr Bharati. Some of the strains used include a panel of 30 New York/New Jersey strains representing 3,000 isolates, 56 Japanese isolates, 119 Indian isolates and eight Canadian isolates. But is this â€œwonder drugâ€? going to be available soon? For this to happen, the fledgling startup urgently needs funds to speed up the clinical trials. Few million dollars are required to conclude the trials faster. â€œThe main hurdle is lack of adequate financing to complete the clinical trials quickly,â€? Dr Ramachandran confessed. GangaGen, after the meeting with the USFDA in March 2010, has prepared StaphTAME formulation for intra-nasal use. The company has also scaled up manufacturing efforts to support clinical studies. The phase I & II studies will include safety, dosing, and preliminary efficacy testing. GangaGen is clearly the world leader in developing such a â€œsuperbugâ€? killer product from phages. Exponential Therapies, which has been developing a similar product since 1994 closed the research program in 2005. Another US-based company, Phage Therapeutics in Seattle, Washington, too had started to develop a product against MRSA in 1997 but wound up in 2003. Will NMD-1 be the â€œantibiotics killerâ€?? About 82 years ago, Alexander Fleming discovered antibiotics and penicillin became a wonder drug in the next few decades. In the six decades following, medical researchers have developed a wide range of antibiotics that treat several infectious diseases. However, in the last two decades, scientists and commentators have started to write premature obituaries of antibiotics. In fact, the latest headlines in newspapers based on the NMD-1 reports have a common theme: â€œIs it the end of antibiotics?â€? But is it really so? What is happening today seems to be an exact replica of the events more than 16 years ago. In March 1994, the venerable Newsweek magazine ran a report, â€œThe End of Antibiotics?â€? by Sharon Begley. The reference was to the discussions at the annual meeting of the Association of Advancement of Science in San Francisco that concluded in February 1994. Microbiologist Alexander Tomasz of Rockefeller University warned, â€œmany common bacteria are evolving resistance to more and more antibiotics.â€? The data for 1992 indicated that resistant infections killed 19,000 patients in hospitals in the US that year and contributed to the death of 58,000 more outside. In 2005, more than two million people in the US were affected by infections and 90,000 of them died. In the UK, there were 3,00,000 infected patients with 5,000 deaths, according to information compiled by science writer, Thomas Hausler in his book, 'Viruses vs Superbugs'. Even after 16 years, antibiotics continue to thrive even though more resistance has been reported regularly. Will the August 2010 obituary on antibiotics also be another such premature exercise? Majority of the hospital infections are caused by the Staphylococcus aureus bacteria. Dr Tomasz has found that 70 percent of the known 3,000 strains of this bacteria found all over the world belonged to just five strains. What this means is that it doesn't matter where the bacteria was found first. These tiny microbes have always had a way in spreading themselves to all parts of our planet. So blaming a particular city, hospital, or country does not help the cause of finding a quick cure. Phage therapy i.e., using viruses that kill harmful bacteria, one of the most promising cures around the corner. It is certainly not the end of antibiotics. And NMD-1 will not be the â€œantibiotics killerâ€? anyway. Why phage therapy is not already a treatment of choice? In order to use phage as a therapy, the pathogen causing the infection must be properly diagnosed so that the appropriate phage can be used. Phages are highly specific and a given phage such as the cholera phage will kill only cholera bacteria but not others. Diagnosis is quite difficult. When Penicillin was discovered in the 1930s, physicians in the Western world abandoned phage and embraced antibiotics since they had broad spectrum activity. Penicillin could be used to treat many infections. In fact, it is the overuse and misuse of antibiotics over the last six decades that led to the emergence of robust antibiotic-resistant pathogens like MRSA. The second major reason why pharma companies did not pursue phage therapy is the perceived lack of patent protection, for naturally occurring phages. Narayanan Suresh and Jahanara Parveen"GangaGen's StaphTAME is ready to tame superbugs"As a global debate rages on the future of antibiotics due to the presence of yet another 'superbug', NDM-1, resisting all known antibiotic treatments, the health community is seriously looking at alternate options. One of the most promising alternative, appears to be the use of bacteriophages-the viruses that kill bacteria-which was used extensively in many parts of the world, prior to the discovery of the wonder antibiotic, penicillin, in the 1920s. The super convenience of penicillin and other antibiotics, relegated phages to the background. In this gloomy scenario, there is hope. GangaGen Biotechnologies, founded by a renowned molecular biologist from AstraZeneca 10 years ago, to relentlessly pursue phage research, is close to getting the world's first phage-based product ready to tame the deadly bacteria strains stalking patients around the world. GangaGen is ready to start the human trials of the world's first 'superbug' killer, StaphTAME, a genetically-modified protein developed from phages. In an exclusive interview to Narayanan Suresh and Jahanara Parveen of BioSpectrum, GangaGen's founder, Dr J Ramachandran, talks about his breakthrough product, his passionate search to find a 'superbug' killer, and the help he needs from the global society, to complete his dream of a 'harmful bacteria-free' world. Q What are the current areas of research at GangaGen? GangaGen has developed a highly proprietary product called StaphTAME (also known as P 128) for the control of the superbug Methicillin Resistant Staphylococcus Aureus (MRSA), which is currently the most serious hospital-acquired infection. All preclinical development of StaphTAME has been completed, and a successful pre-IND meeting with the US Food and Drug Administration (FDA) has been concluded. GangaGen is preparing to conduct clinical trials of StaphTAME later this year, both in the US and in India. StaphTAME is a recombinant protein that kills MRSA and all Staph bacteria very rapidly (in minutes) by a novel mechanism. Pseudomonas aeruginosa is the most antibiotic-resistant pathogen after MRSA, and is the source of major infection in burns and wounds. GangaGen is developing a proprietary product for the control of Pseudomonas aeruginosa, that is currently undergoing preclinical development. GangaGen hopes to advance this product into clinical trials next year. GangaGen's research team is also engaged in the discovery and development of phage-based products for the control of other pathogens including Clostridium difficile, which often emerge as a secondary infection following antibiotic treatment, and is rivaling MRSA as a hospital-acquired infection in the UK. Q Is there enough innovation/research happening in the area of phage therapy globally? Which are the other companies working in this area? GangaGen is a pioneer in developing innovative products based on phages. Many of the phage companies around the world did not pursue innovation, but rather focused on the production of natural phages that have some limitations. Release of endotoxins from the pathogens killed by phages, immune response to the phage, and potential for acquiring toxic genes from a pathogen and transferring it to the beneficial bacteria present in the patient, are some of the problems in the use of naturally occurring whole phages. GangaGen developed the proprietary 'Lysis-deficient Phages' to circumvent these problems through genetic engineering of the natural phages. Lysis-deficient phages kill the pathogens as effectively as the natural phages, but due to the deletion of the 'endolysin' gene, do not release phage or endotoxins, and do not have the opportunity to transfer toxic genes. Two patents on the Lysis-deficient phages were issued to GangaGen by the US Patent Office in 2005. This accomplishment of GangaGen was described in an article in BioSpectrum in July 2004. Phage Therapeutics in Seattle, Washington, US, was started in 1997 to develop natural phage against MRSA but closed down in 2003. Exponential Therapies, the oldest phage company, started in 1994, but closed the phage program in 2005. There are several small companies developing natural phage for agricultural use and animal health in various stages of development. Q In spite of its vast potential, why has the phage technology/therapy failed to win the right recognition in India, and also in other countries? It is really unfortunate that phage therapy has not reached its potential in spite of the remarkable success it demonstrated in the first half of the last century, both in Europe and India. Felix d'Herelle, the French-Canadian scientist who demonstrated the efficacy of phage for the control of shigella infection in the World War I years in France, came to India in 1927, and showed that cholera could be effectively controlled with phage. Impressed by this, Morison, the director of King Edward VII Pasteur Institute in Assam, tried phage therapy in villages in Assam that had cholera epidemics every year. Nowgong, the village that used phage treatment had less than 10 deaths due to cholera, whereas Habibganj that did not use phage had over 300 deaths. This study was published in the Transactions of the Royal Society for Tropical Medicine and Hygiene in London in 1935, and is described on the GangaGen website. The reason that phage therapy did not emerge as the treatment of choice for infection are manifold. In order to use phage as a therapy, the pathogen causing the infection must be properly diagnosed, so that the appropriate phage can be used. Phages are highly specific, and a given phage such as the cholera phage, will kill only cholera bacteria and not others. Diagnosis is not easy even now, and in the early part of the past century, it was extremely difficult. When Penicillin was discovered in the late 1920s, physicians in the Western world abandoned phage and embraced antibiotics, since they had broad-spectrum activity. Penicillin could be used to treat many infections. In fact, it is the overuse and misuse of antibiotics over the last six decades, that led to the emergence of robust antibiotic-resistant pathogens like MRSA. The second major reason why pharmaceutical companies did not pursue phage therapy is the perceived lack of patent protection for naturally occurring phages. In the context of debate on the presence of superbugs and predictions of the end of antibiotics, what role can phage therapy play to restrict superbug infections? Lysis-deficient phage and phage-based products like StaphTAME can play a very important role in controlling the superbugs, as they have been shown to effectively kill these antibiotic-resistant pathogens in the laboratory as well as in animal models. What stands in the way of phage products is the lack of proper placebo-controlled double blind clinical trials according to the US FDA standards. GangaGen is preparing to rectify this by conducting the phase I/II/III trials with StaphTAME. Q What are the significant breakthroughs achieved by phage therapy in recent years? Apart from the results achieved by GangaGen, a company in the UK has reported that middle ear infection could be treated successfully with phage against Pseudomonas bacteria. Q What hurdles do you anticipate in the path of phage therapy solutions? The main hurdle is the lack of adequate financing to complete the clinical trials quickly. Narayanan Suresh and Jahanara Parveen in Bangalore ]]> <![CDATA[Patients' awareness can boost clinical market]]> https://biospectrumindia.com/news/95/1013/patients-awareness-can-boost-clinical-market.html https://biospectrumindia.com/news/95/1013/patients-awareness-can-boost-clinical-market.html Wed, 08 Sep 2010 12:04:00 +0530 The Indian CRO market might have become the hot spot for its high patient recruitment rate but the system is beset with its own set of challenges and loopholes. Patient recruitment and retention remains a huge challenge for many CROs. Globally, at least 80 percent of pharmaceutical trials do not meet enrollment deadlines, with 52 percent trials delayed by one-to-six months resulting in a loss of $1.3 million/day for a given candidate drug. Further, only 1 out of 20 patients who respond to clinical trial recruitment promotions, eventually, enroll in a study, and patient non-compliance can run as high as 80 percent; and up to 40 percent of patients are lost to follow up, in a clinical trial. This is coupled with pricing and cost cut pressures faced by CRO companies, post the global downturn. In this backdrop, India has a basket of opportunities to offer to the $18 billion global CRO industry in the form of skilled manpower and expertise, cost effectiveness, easing up of  regulations and infrastructure. With a number of drugs going off patent by 2012, many companies will now turn to low cost destination regions like India and China to conduct clinical trials, not only because of the cost factor but also because of the large availability of a diverse patient pool. Industry experts claim that patient recruitment in India is four times faster than in the West. This, in turn, accelerates drug discovery and development processes that are crucial in the face of depleting R&D pipelines.   According to the BioSpectrum-ABLE annual survey of the biotechnology industry for 2010, the CRO segment has registered a growth of 28 percent in 2009-10, over the previous year’s total segment revenue of 2,062 crore. Exports continue to dominate this segment, accounting for over 90 percent of the total revenues. When the going gets tough Clinical trials in the country are conducted as per the ‘Ethical Guidelines for Biomedical Research on Human Participants’, issued by the Indian Council of Medical Research, 2006. These guidelines are consistent with the subject protection tenets of the Declaration of Helsinki and CIOMS (Council for International Organizations of Medical Sciences). Patient recruitment and retention practices in India have their own set of shortcomings, volunteer safety being one of them. It has been brought to the observation of the Indian government that, off late, a number of big pharmaceutical companies have been conducting trials in India, without being reviewed by the ethics committee. There were reports doing the rounds of these very companies not taking patient consent, while enrolling them for a trial. In April 2010, the government suspended trials in two states for Merck’s cervical cancer vaccine, Gardasil, after reports that the vaccine were allegedly tested on children before being tested on adults, leading to death of six of them. Earlier, in the late 1990s, there was a case of drugs being tested by a reputable big pharmaceutical, on patients in India without being tested on animals. This is how putting in place a system of stringent checks and balances becomes imperative. Industry stalwarts opine that India has a meticulous regulatory structure as far as patient recruitment is concerned. “In fact, Indian authorities are even more stringent when we submit our data for trial approval. The data that the Indian government officials ask us to submit is not asked even by international regulatory agencies,” commented an industry observer. The root problem stems from the lack of adherence and execution by investigators and doctors at the site level,” says Nidhi Saxena, founder, Karmic Life Sciences, Maharashtra. A key challenge is also the lack of awareness among patients enrolled for these trials. Even members of the ethics committee are unaware of certain guidelines. “There are some members in the committee who do not even understand good clinical practice (GCP) guidelines, when we submit our proposals,” adds Saxena. The industry believes that a large section of the Indian community, unfortunately, associates clinical trials with “clinical trial deaths”, while ignoring the benefits of enrolling for clinical trials. “In indications like oncology, where drugs in the market are limited and sometimes not efficacious, clinical trials come as a boon, wherein, patients can go in for drugs which might have an efficacy. In geographies like the US and Europe, people volunteer for a trial with the hope of being cured,” adds Dr Apurva Shah, managing director, Veeda Clinical Research. However, Dr Shah, along with other industry experts, opine that in the lure of “access to free medicines”, patients in India as well as physicians, fail to assess the pros and cons of a drug before participating in a trial. Typically, many patients, primarily from the weaker socioeconomic section of the society, show a sense of apprehension and fear of being used as ‘guinea pigs’ for these trials.  Says Dr Arun Bhatt, president, Clininvent, “ A large number of trials take place in public hospitals, most patients who take part in trials are from the weaker socioeconomic section of the society. This creates significant ethical challenges for the investigators.” Many investigators do not have the time and patience to explain the  details of the trial to their patients, before taking their consent, which ideally is, the protocol. Says Dr Shah, “Patients blindly trust their physician, and generally do not get into the details of the information provided about the trial.” Ideally, the consent is taken by the investigator. The company’s CRAs monitor the consent for compliance to regulations and GCP. The challenge is to train the sites in the correct way of taking and documenting consent. “Yes, it is a frequent problem. If a person is knowledgeable and well-to-do, his interest in participation is low; and if he is illiterate, his understanding is low and suspicion, high,” says Dr Sanjeev K Chaudhry, CEO, Super Religare Laboratories. Another area of concern is the endangered investigators. “There is a lack of good clinical trialists or investigators in India. It is clear that the country needs more investigators. There is also a shortage of people to work with the clinician investigator,” says Dr Ramesh Jagannathan, director, Clinical Research, Astra Zeneca. Lack of  written documentation and maintaining databases of patients for different therapeutic segments is now snowballing into a major hurdle. Says Saxena, “Unfortunately, data is still maintained on paper. We have not yet got into the culture of maintaining information in electronic  records.”  This  delays the patient enrollment process. “Numerous clinical sites in India are government centers that do not maintain a database of patients, especially those who are in need of clinical trials for indications like oncology.” says Dr Anand Bidarkar, vice president, Business Development, Siro Clinpharm. Even patients fail to maintain records of their medical history and past treatments. “Many a times we see patients do not maintain a history of their treatment, and we cannot let a patient go ahead with a trial unless we know his medical history,” adds Dr Bidarkar. “In addition to a diminishing supply of clinical investigators, a major difficulty lies in the lack of a coordinated and focused system of design, conduct, or analysis of trials. This results in improper documentation. So when the regulator demands for a particular document, companies don’t have them, “ points out Larisa Nagra, former senior director of Clinical Operation, Asia Pacific, ICON Clinical Research.The running of clinical trials, therefore, demands a concentrated effort by a team, including trialists and information technology specialists. CROs should evaluate new approaches to perform and record clinical research, in order to enhance patient safety and streamline administrative approaches, she adds. CROs also face the problem of paucity of patients in particular disease areas. Agrees Saxena, “India might have a large patient pool, but many a time there is a paucity of patients for certain disease segments.”  This apart, many industry experts believe that in terms of infrastructure, many sites lack the basic facilities and equipments  like computers, centrifuges, refrigeration. The dire need of the hour is to increase the number of clinical sites, if India has to move from being a destination for drug development to that of drug discovery hub. “Today, out of 70,000 hospitals only 500 hospitals participate in clinical trials. The total number of trials in India clocks at about 1300, out of the total number of 67000 global trials,” adds Saxena. This number is predicted to shoot up in the coming decade, with the demand for cheaper medicines. “When compared to other countries, the number of trials conducted in India has decreased by 10-15 percent between 2008 and 2009, while the decrease is only 5 percent in China,” adds Dr Bhatt. Steps for volunteer safety With volunteer safety being the stumbling block, the government has come up with steps to improvise the situation. The Drugs Controller General of India (DCGI) has announced that India is soon to begin regular and on-the-spot  inspection of clinical trial sites to ensure transparency and volunteer safety in the country.  Prior to this, clinical trial sites were either inspected by international agencies like the FDA or the UK MHRA.” Why should the FDA be the only agency to inspect our clinical trial sites,” asks Dr Bhatt. This could, perhaps, change the landscape of the clinical trial industry in India, which has been beset with lapses in adherence to safety guidelines. Dr Surinder Singh, DCGI  recently announced, “This will commence in September 2010, and we will begin by inspecting trial sites in Bangalore, Mumbai, Kolkata, Chennai and New Delhi. This step will not only strengthen the clinical trial scenario in India but also ensure that volunteers are in safe hands, and that there are no violations in protocols.” For this, there will be a collaboration with the USFDA  in terms of training of inspectors. “Altogether we have 169 inspectors, 25 have already been trained and we another 20 inspectors are to be trained to audit these sites,” confirmed Dr Singh. The industry again has it own set of concerns in this front. “The DCGI office unfortunately does not have enough trained staff, and my only concern is that this initiative should be devoid of the usual Indian bureaucratic attitude. Otherwise, it would be a good check and a potent tool of vigilance,” concludes an industry observer. Nayantara Som (inputs from Rahul Koul & Jahanara Parveen) ]]> <![CDATA[Clinical Trial Registry to bring transparency in India]]> https://biospectrumindia.com/news/95/2853/clinical-trial-registry-to-bring-transparency-in-india.html https://biospectrumindia.com/news/95/2853/clinical-trial-registry-to-bring-transparency-in-india.html Wed, 08 Sep 2010 11:48:00 +0530 Today, world over, there is a need for transparency, accountability and accessibility in order to re-establish public trust in clinical trial data. Clinical trials hold enormous potential for benefiting patients, improving therapeutic regimens and ensuring advancement in medical practice, that is evidence-based. However, the data and reports of various trials are often difficult to find. However, this tendency for availability of only selective information from the myriad clinical trials conducted, is not commensurate with the practice of “evidence-based medicine”. Today, world over, there is a need for transparency, accountability and accessibility in order to re-establish public trust in clinical trial data. And this would be feasible only if all clinical trials conducted, are registered in a centralized clinical trials registry. Hence, Indian Council for Medical Research (ICMR)’s National Institute of Medical Statistics (NIMS) has set up a registry for clinical trials in June 2009. The registry will collect information on all prospective clinical trials to be conducted in India, and make this information available to the public. The Indian registry is planned to be a freely available and searchable primary register. To register a study, trialists need to submit information including the basic data required by the International Clinical Trial Registry Platform (ICTRP), and will receive a WHO-assigned unique identification number. In addition, Clinical Trials Registry, India (CTRI), will encourage trialists to include subsequent protocol amendments and give regular updates on the status of trial. Responding to the mandatory registry of clinical trials, Dr Sanjeev K Chaudhry, CEO, Super Religare Laboratories, noted that the CTRI has many advantages as it gives an up-to-date information about the number of trials happening in India, along with the sites. It acts as a one-stop shop for those seeking information about clinical trials in the country.  It enables transparency of data, and makes it available for publishing in reputed journals. If results are added after completion of the clinical trials, the total process would be open to scrutiny. Having a similar view, Dr Apurva Shah, group managing director, Veeda Clinical Research, said: “Mandatory registration brings transparency in the system, gives confidence to the new entrants (sponsor); and gives the feel about the type of trials being conducted in India. At the operational level, it gives insight to the experience/capabilities of the investigator. At the business level, it gives information about the sponsors, CROs involved and the indications they are working on. On the whole it’s a very healthy thing, that will benefit all parties concerned.” Dr Anand Bidarkar, vice president, Business Development, Siro Clinpharm, noted that it will bring about transparency, and also patients can look up the website for information on the ongoing trials and arrive at a decision, particularly patients who are in dire need to medicines. Dr Vijai Kumar, chief medical officer and president, Excel Life Sciences, has different views. He says, “I don’t think it benefits the CRO industry as much as the general public. It helps the community at large, to know about the nature of trials going on in the country. It is directed towards increasing community awareness about clinical research and, can be used as a tool to encourage community participation.” Sharing his thoughts on the process of registering for a trial, Dr Arun Bhatt, president, Clininvent, said,  “The CTRI is not yet efficient in the process of registration. It takes a lot of time in completing the registration process. This has added extra work for the CROs. But the registration has brought about transparency in trial registration.” On the other side of the mandatory registry of clinical trials, Ms Nidhi Saxena, founder and CEO, Karmic Life Sciences says, “Though it will bring transparency into the system, foreign companies have a fear of confidential data getting picked up by competitors.  So there should be some element of discretion.” In conclusion, setting up a Clinical Trials Registry would ensure that all clinical trials conducted in India are publicly declared and identifiable, and a minimum set of information of all clinical trials is freely available to physicians, health researchers, academicians, pharmaceutical industries as well as the common man. While bringing in transparency in the system, CTRI should try to address some of the concerns raised by the CROs. Narayan Kulkarni (with inputs from Nayantara Som, Rahul Koul & Jahanara Parveen) ]]> <![CDATA[Govt steps in to speed growth]]> https://biospectrumindia.com/news/95/7041/govt-steps-in-to-speed-growth.html https://biospectrumindia.com/news/95/7041/govt-steps-in-to-speed-growth.html Wed, 08 Sep 2010 11:42:00 +0530 India has become a favored destination for organizations to conduct clinical trials. The key factors for this can be attributed to easy access and availability of a large, diverse and therapy-näive patient population, with a vast gene pool and lower cost of technical services, resulting in lowest per patient trial cost. The number of trials being conducted in India has increased in the last few years. The Central Drugs Standard Control Organization (CDSCO), India’s main regulatory body for pharmaceuticals and medical devices, has permitted the Clinical Research Organizations(CROs) to conduct 401 trials in 2007, 521 in 2008, 453 in 2009; and as on June 2010, 251 trials have been permitted. The number of trials include both the global and local trials The year 2008 witnessed a significant increase in the number of local trials, over the previous year. And this number has dropped slightly in 2009. On the other side, the number of global clinical trials remained more or less at the same level in the last three years. On August 6, 2010, Union Minister of Health and Family Welfare, Government of India, Ghulam Nabi Azad  said in the Lok Sabha that a substantial number of clinical trials were permitted as part of global clinical trials and local clinical trials for marketing authorization, during last three years in India.  The CDSCO permitted 259, 246, 258 and 117 global trials in 2007, 2008, 2009 and up to June 2010  respectively. The number of local clinical trials permitted for 2007, 2008, 2009 and up to June 2010 were 142, 275, 195 and 134 respectively. These numbers do not include Bio Availability/Bio Equivalence/type trials. More than 100 CROs are working on clinical trials in India. No company in India can initiate any clinical trial of a new drug without prior approval from CDSCO, Directorate General of Health Services, Ministry of Health and Family Welfare, Government of India. Clinical trials are permitted in the country as per Rule 122DA, 122DAA, 122DB 122E and Schedule Y of Drugs & Cosmetic Rules. There are a large number of pharmaceutical companies and CROs  like GlaxoSmithKline, Johnson & Johnson, Sanofi-Aventis, MSD, Eli Lilly, Novartis, Bristol Myers Sqibb, Bayer Healthcare, Astra Zeneca, Pfizer  and clinical research organizations (CROs) like Quintiles, ICON, GVK BIO Siro Clinpharm, Parexel, PRA International PPD, Covance, Omnicare, Kendle are seeking permission from CDSCO to conduct clinical trials in the country. Today, most of the big pharmaceutical companies are conducting multi-centric trials in India, with some of them operating for more than 15 years. Eli Lilly and Pfizer are one of the earliest big pharmaceutical companies to conduct clinical research in India, and commenced their captive operations in 1995. This was followed by a clutch of other companies in the early to mid 2000, like, Sanofi-Aventis, Bayer, Novartis Astra Zeneca and Johnson & Johnson. The last two to three years have witnessed  increased presence of other big pharmaceutical companies, like, Merck, GlaxoSmithKline, Bristol-Myers Squibb, and some of the larger biotechnology companies, like, Amgen, Biogen Idec. These companies are looking to India for almost all therapy areas. Most of the leading global CROs have set up services in India-Quintiles, PPD, Kendle, Covance, PRA International, Criterium, Chiltren, Omnicare, ICON International, I3 Research, Parexel, iGate Clinical Research, Medpace, Makrocare, Excel Life Sciences, Clinsys Clinical Research, Pharma Net-and are linking India to the global network, strongly. Some of the leading local CROs in India include ClinInvent, CliniRx, Synchron, Karmic Life Sciences, Accutest, ACT, CliniRx, Max Neeman CRO, Semler research, Vedic Life Sciences, Siro Clinpharm, Lambda Therapeutics,  Ecron Acunova, GVK Biosciences, Reliance Life Sciences Clinical Research,  Clinace, Lotus Labs, Clinigene International, Vimta Labs Ltd, Synchron Research and Veeda CR.  The CROs such as Raj Biotech, INTOX, Jai Research Foundation, Bioneeds, Vimta Labs, Indian Institute of Toxicology, ClinTech Research India, Sheron Biotech, International Institute of Biotechnology and Toxicology (India), SGS India, Clintox Bioservices, Dabur Research Foundation, Advinus, RCC and Vivo Biotech are specialized in conducting preclinical studies. Focus areas In India, most CROs focus on conducting phase III and IV studies, because of the development capabilities in the country. However, the CROs are gradually seeing a shift to phase III trials. Dr Sanjeev K Chaudhry, CEO, Super Religare Laboratories Ltd noted, “There are more than 50 CROs conducting phase II-IV clinical trials and 15-20 doing phase I clinical trials. Meanwhile, Dr Apurva Shah, group Managing Director, Veeda Clinical Research said that about 2-3 CROs are doing phase I trial, 15-20 CROs are involved in phase II trials, 12-15 CROs are involved in phase III and 20-25 CROs are doing Bio Avaibility/Bio Equivalence (BA/BE) studies. “Most CROs carry out phase II-IV studies. Very few CROs carry out phase I studies. BA/BE is a different segment. The number of BA/BE CROs could be around 100,” observed Dr Arun Bhatt, president, ClinInvent. Meanwhile Dr Anand Bidarkar, vice president, Business Development, Siro Clinpharm, noted that the Indian CROs are doing 100  phase I studies, 300 phase II studies,  650 phase III studies and 120 of phase IV studies.” In terms of key therapeutic areas, the CROs are focusing on oncology,  neurology, respiratory, diabetes, anti-infective, psychiatry,  endocrinology, central nervous system, cardiovascular system. Diabetes ranks first as a vast majority of the population are diabetic. Currently, India has about 1500-2000 clinical investigators. The present growth in investigator sites is around 30-40 percent per year. Dr Arun Bhatt of Clininvent said,” If we want to increase the number of sites faster, the industry and government will have to train new sites on a war footing.” Ms Nidhi Saxena, founder and CEO, Karmic Life Sciences, observed that there is a shortage of trained clinical investigators but no specific number can be put. Commenting on the demand side, Dr Anand Bidarkar of  Siro Clinpharm said, “We need three times the figure mentioned above.” Sharing similar views, Dr Apurva Shah of Veeda Clinical Research said,” The industry is growing at the rate of over 30 percent. The industry has an increasing need for investigators trained in conducting clinical trials. Currently, the clinical trials are restricted to some specific institutions/investigator. We have to build the capacity by bringing awareness in  people, media, non-governmental organizations (NGOs), about clinical trials, and train them on their responsibility.” Government initiatives To support the growing CRO industry in India, the regulatory authority, DCGI, has adopted short-term and mid-term goals. It has started adapting itself to meet the demands of the industry, in terms of quality, transparency and accountability of global trials. Some of the short-term (2008-10) initiatives adopted by DCGI include: robust review process for clinical trial proposals mandatory registration of clinical trials in centralized clinical trial registry with effect from June 15, 2009 training of personnel in clinical trials site inspections inspection of clinical trial sites to be an ongoing activity; checklist of audits developed the number of inspectors being strengthened registration of CROs harmonization of regulations on toxicity, definitions of phase 1 consistent with ICH guidelines support development of regulations and infrastructure for early stage First-in-Man studies (phase 0 or micro-dosing). In addition to this, DCGI has mid-term strategy (2011-12) that includes guidelines for registration of ethics committees/IRBs, registration of ethics committee;  registration of investigation sites and investigators;  GCP training of investigators by an accredited body;  penal provisions for violation of clinical trial regulations under consideration;  conducting micro-dosing studies (that is, First-in- Man or phase 0). Some of the recent initiatives by DCGI underscore the fact that the regulatory agency is becoming more pro-industry, more vigilant and more efficient, which  is the need of the hour. The growing CRO industry has brought a significant change for the betterment in medical practices, patient access, and patient care. Currently, the clinical research scenario in the country is at an inflection point, and all the stakeholders including regulators, need to reassess their strategy in terms of the latest global developments. The Indian CROs have to seek out, develop capabilities and conduct specialized studies to make a mark in the global clinical research space.  For India to remain a key to the global clinical trials market, pharmaceutical companies, CROs, site management organizations (SMOs), policymakers and academia need to work together, to address many challenges that will bring greater quality and efficiency to conduct global trials in India. ]]> <![CDATA[CROs working on expanding geographical reach]]> https://biospectrumindia.com/news/95/4567/cros-working-on-expanding-geographical-reach.html https://biospectrumindia.com/news/95/4567/cros-working-on-expanding-geographical-reach.html Wed, 08 Sep 2010 11:21:00 +0530 In an effort to assess the trends in Contract and Clinical Research Organizations (CROs) in Asia Pacific after the global economic slowdown, BioSpectrum conducted a survey of the CRO industry. BioSpectrum sent a questionnaire in June 2010 to 250 CROs from all across Asia Pacific region. The scope of the survey included the multinational, regional and local CROs with revenue upto $1 billion. In all, 39 CROs from India, China, Malaysia, Singapore, Australia, Taiwan, Thailand, South Korea and Hong Kong participated in the survey. The results of the survey when further corroborated with the market experts and analysts, BioSpectrum team found it to be a representative of the industry on ground situation. We discovered that 85 percent of the CROs are working on expanding the geographical reach so as to establish their direct presence in other countries and regions. 67 percent of the respondents have plans in place for client expansion, followed by product development (51 percent) and revenue growth (41percent). Projected growth in 2010 41 percent of CROs who responded positively noted that they projected a growth of over 26 percent in 2010 while 49 percent of them noted that they are looking forward for a growth in the range of 10-25 percent in 2010. 67 percent of CROs pointed that Asia Pacific is the base for doing phase III and phase IV studies due to the large patient population in the region, cheap labor, sponsors eagerness to launch the products in this growing market. Only 12 percent of the trials conducted in Asia Pacific are related to phase I trial, as the CROs are not keen on taking up phase I trials, due to regulations and restrictions from the local government agencies. 21 percent of the CROs are doing phase II trial studies in the region. Of all the employees working in CROs in Asia Pacific region, three percent are controlling the business in the region. About 18 percent of the staff are working towards getting business for the companies through sales and marketing activities. While a big chunk of 71 percent of the staff, who can be called as the back bone of the organization, are doing the behind-the-screen job, that is, research and development work. Leading therapeutic focus areas S No Therapeutic Area Respondents (%) 1 Oncology 53 2 Cardiovascular 45 3 Central Nervous System 30 4 Diabetes 23 5 Metabolic diseases 19 6 Infectious disease 18 7 Dermatology 18 8 Opthalmology 13 9 Neurology 13 10 Respiratory 13 11 Inflammation 11 12 Medical devices 11 14 Psychiatry 10 15 Endocrinology 10 16 Gastroenterology 10 ]]> <![CDATA[RFCL to make hematology reagents for Diagon]]> https://biospectrumindia.com/news/95/4760/rfcl-to-make-hematology-reagents-for-diagon.html https://biospectrumindia.com/news/95/4760/rfcl-to-make-hematology-reagents-for-diagon.html Wed, 08 Sep 2010 11:18:00 +0530 RFCL, Gurgaon-headquartered biosupplier has signed a technology transfer agreement with Hungarian clinical diagnostic manufacturing company, Diagon. The former will accept the formulation and technology inputs for manufacturing of reagents for the leading 3-part and 5-part differential instruments at the new manufacturing facility of Diagnova, RFCL in Dehradun. RFCL's strategic business unit, Diagnova, will manufacture and sell these reagents in India to competitors like Mindray, Sysmex, Coulter, and will be used in Diagnova’s own installations of Lablife Noble III, H3D, D5 Supreme. The manufacturing plant is dedicated for manufacturing in vitro diagnostics (IVD) products, and comprises of separate facilities for manufacturing of diagnostic kits/reagents which include biochemistry, immunology, serology, rapid card tests and hematology, to produce a range of products in different SKUs. The entire facility has been designed as per latest cGMP requirements, approved by the State FDA. The facility is accredited with ISO 9001:2008, ISO 14000:2004, and is in the process of obtaining the ISO-134854 and CE certification. Thermo Fisher opens tech center in China Thermo Fisher Scientific, a major technology provider to the life sciences industry, has opened a technology center in Shanghai (China), building on its engineering and development capabilities, to meet the specific needs of customers in China. The center houses engineers and support staff, focused on developing a robust product pipeline to serve China-based customers across a range of industries. "The China Technology Center is another step in our ongoing investment to expand our operations there, and leverage our depth of capabilities to develop and manufacture products in China for China," said Marc N Casper, president and CEO, Thermo Fisher Scientific. The China Technology Center, along with a new demonstration center in Beijing, China, is part of Thermo Fisher's continuing strategy to align with the leading educational, industrial and commercial initiatives in the region. The company first entered the China market 30 years ago, and began to establish an extensive manufacturing footprint shortly thereafter. EMD Millipore, Luminex in distribution deal EMD Millipore, the life sciences division of Germany's Merck, has commenced worldwide distribution of the new Magpix system, from US-based multiplex technology leader Luminex. EMD Millipore acquired the original Luminex reagent partners – Linco and Upstate – for life sciences research in 2006. Since that acquisition, the company has strengthened its commitment to the xMAP platform through its growing line of Milliplex Map kits, analysis software, and global salesforce. Based on Luminex's xMAP Technology, the easy-to-use, low-maintenance Magpix instrument is compact – comparable in size to a desktop computer – making it attractive to smaller and lower-volume laboratories and institutions with limited resources and bench space. The instrument is said to provide fast, accurate and easily reproducible results, helping to advance research across many disease states such as metabolic, inflammation, toxicity and neuroscience, as well as applications in oncology and cell signaling. ]]> <![CDATA[Genaxy Scientific targets automation and proteomics]]> https://biospectrumindia.com/news/95/2562/genaxy-scientific-targets-automation-and-proteomics.html https://biospectrumindia.com/news/95/2562/genaxy-scientific-targets-automation-and-proteomics.html Wed, 08 Sep 2010 11:16:00 +0530 —Navneet Trehan, CEO, Genaxy Scientific, New Delhi Genaxy as a biosupplier company has generally been known for its plasticware products. But thanks to the new tie-ups, the company has expanded its product portfolio, to offer many new products. In an exclusive interview with BioSpectrum, Navneet Trehan, CEO, Genaxy Scientific, throws light on the company name change, collaborations, challenges and strategy for the company’s future. Q What prompted the change in the name from Axygen Scientific to Genaxy Scientific? The change in the name was actually oriented towards having a slightly different identity from Axygen, US. There was some confusion in the field, with Axygen, India, and Axygen, US, being considered as a single entity. We used to receive many queries meant for Axygen, US. Although we started as an offshoot of Axygen, US, we always had a distinctive identity and have not claimed to be the subsidiary of Axygen US. However, our relationship with the company remains the same, and we continue to market the entire range of products of Axygen, US. Besides that, inspite having diversified into instrumentation and other wide range of products, we were not being recognized for anything but plasticware. That alerted us and we, Genaxy, do not want to be known only as a plasticware company, but as a one-stop shop or full-lab solutions provider. Q What kind of collaborations do you have with other companies, worldwide? We have a collaboration with Corning and take care of all their government businesses. We also have also collaborated with Qarta Biotech, US, for marketing their PCR products in India. The uniqueness of these products is that they are room-stable products, and have a long shelf life. These products are very innovative due to the fact that despite being on the shelf for as long as 20 years, 90 percent of the activity of these products remain unaffected. These products have no competition currently in the Indian market. Genaxy has also tied up with a company, GVS, and for the first time, have entered the chromatography area, following a tie-up with the US company, Atiji and we market their range of solid phase extraction (SPE) columns, in India. We are also marketing the filter membranes, syringes and filter papers, besides water purification system with ion technology. Our principal company, Serva, has no competition in India. The specialty of Serva products is that they are  customized according to the needs of the scientists. Q What is the nature of Genaxy’s relationship with the academia? We are closely associated with the industry, and are also involved in providing career guidance to the biotechnology students. Last year, I conducted an orientation program at Amity University. We have been urging the academia to bring in some changes in the curriculum. To give them a better overview of the industry and to help them understand the industry requirements better, we have started recruiting professionals from the industry. At the same time, I feel that if we do not provide the right path to our biotechnology students, the future growth of this industry in India could be affected adversely. I believe that there is a need for standardization in the biotechnology education in India. Q What is the current situation of biotechnology in India? What we see today in the biotechnology arena in India is more of biopharmaceuticals. The contribution towards the pure biotechnology sector is more from the Department of Biotechnology (DBT) and the Department of Science and Technology (DST) funding. Innovation seems to be the only key for the future of this industry. There should be a strong bridge between the industry and the academia. The role played by the DBT has been very encouraging, and they have taken the significant steps for the advancement of biotechnology in India. Q What kind of presence do you have to reach out to your clients within the country? How do you provide technical support? Presently, we work with 200 distributors across India. We have established regional offices across India in Bangalore, Pune, Kolkata and Mumbai; and a customer support team. We also have two separate teams for product and brand management. Dr Anita Kapur heads the product management team at Genaxy. Besides having PhDs in our team, we have about 130 post-graduates in biotechnology. Our team is well-trained for new products, and we constantly conduct product seminars at various venues. We have service engineers across the country to provide maintenance of heavy instruments. For any specific queries from the scientists, we get support from our principal companies. Q What are the current challenges in the biosupplier industry? As a biosupplier, we feel that the applications part is increasing, and this is the golden time for biotechnology. All multinational companies see India as a multi-million dollar market. That is the reason for increased competition, with the entry of a large number of companies. However, Government of India should bring restrictions on the products below acceptable quality, that are in the market. The DBT should set and monitor standards for the biotechnology industry, as it is directly related to the research outcome. Q What is the strategy for strengthening your business in the future? Until now, all products that have been launched by Genaxy, have been successful in the market. Our next areas of focus are automation and proteomics. We are now trying to enter the area of heavy instruments such as huge refrigerators, centrifuges. Besides that, as we are already associated with many big hospitals in India, we are focusing on blood banking (healthcare). We will be launching our own low cost-range of electrophoresis equipments targeted at colleges, for the benefit of the students. Most colleges cannot afford such equipments because of the high procuring costs. Also, in the future, we are planning to focus mainly on the proteomics, as we see a huge potential in this area. Our business principle is to provide high quality products to scientists. —Rahul Koul in New Delhi ]]> <![CDATA[Track clear for embryonic stem cell research]]> https://biospectrumindia.com/news/95/1863/track-clear-for-embryonic-stem-cell-research.html https://biospectrumindia.com/news/95/1863/track-clear-for-embryonic-stem-cell-research.html Wed, 08 Sep 2010 11:09:00 +0530 The US FDA’s first clinical trial approval of human embryonic stem cell (hESC) therapy is a milestone for regenerative medicine. California-based Geron Corporation is all set to conduct the world’s first clinical trial of hESC therapy The field of regenerative medicine generates significant public interest, controversy and political debate. And it is no surprise that stem cell therapies are, once again, making headlines. The permission from the US Food and Drug Administration (US FDA) to California-based Geron Corporation, to conduct the world’s first clinical trial of a human embryonic stem cell (hESC) therapy, has not only begun what may be the beginning of a new era for medical treatment, but if successful, could potentially open the doors for clinical testing of more human embryonic stem-cell derived cell therapies. The FDA notification enables Geron to move forward with the world’s first clinical trial of a human embryonic stem cell-based therapy in humans. The phase I multi-center trial is designed to establish the safety of Geron’s lead hESC-based therapeutic candidate (GRNOPC1) in patients with complete American Spinal Injury Association (ASIA) Impairment Scale grade A sub-acute thoracic spinal cord injuries. The FDA approval has happened after a year-long hold on phase I clinical trial in September 2009. The clinical hold was placed following results from a single preclinical animal study in which Geron observed a higher frequency of small cysts, within the injury site, in the spinal cord of animals injected with GRNOPC1. In response to those results, Geron developed new markers and assays, as additional release specifications for GRNOPC1, to prove its safety to the FDA. The company completed an additional confirmatory preclinical animal study to test the new markers and assays, and subsequently submitted a request to the FDA, for the clinical hold to be lifted. Although the primary endpoint of the trial is safety, the protocol includes secondary endpoints to assess efficacy. Once safety in patient population has been established, Geron plans to seek FDA approval to extend the study, to increase the dose and expand the trial, to include patients with severe incomplete injuries, to enable access to the therapy for a broader population. Geron has selected up to seven US medical centers as candidates to participate in this study, and in planned protocol extensions. FDA nod encourages industry and researchers The regenerative medicine or stem cell sector makes its global presence with innovative research work happening all across the globe. Technical innovations and regulatory challenges in one country or region has, a profound impact on the regenerative medicine industry worldwide. Geron’s spinal cord injury repair being the most advanced hESC therapy being tested in humans, the approval has triggered a wave of ebullience from scientists, investors and patient advocates globally. Dr Samuel JK Abraham, director of Nichi-In Center for Regenerative Medicine (NCRM), an Indo-Japan joint venture institute, conducting research and clinical applications-protocol development in regenerative medicine, in Chennai, says, “As long as the safety, purity and potency are ensured, science has to move forward. The study using embryonic stem cell-derived product should go forward, particularly in conditions like spinal cord injury, where there are no definitive treatments.” Dr Abraham, however, suggests that equal importance should be given to autologous adult stem cells, and comparative studies on the antigenicity and efficacy of the presently used embryonic stem cell-derived oligodentrocyte precursor cells versus that of autologous adult (bone marrow, peripheral blood, and olfactory neural ensheathing cells) derived stem cells/precursor cells should be undertaken. Dr Satish Totey, president of Bangalore-based Advanced Neuro-Science Allies (ANSA), a R&D company focusing on different areas of neuroscience, providing a comprehensive scientific approach to stem cell therapy, including basic and clinical research programs, for the development of new therapies; says, “This FDA approval is an excellent development and was long overdue. Geron has an excellent safety and preclinical data on spinal cord injury. This is one area where all other adult stem cells have miserably failed, without any significant improvement.” Commenting on the significance of Geron’s study, Dr Totey says, “Demyelination is central to the pathology of injury, and its reversal by injecting embryonic stem cells-derived oligodendrocytes would be revolutionized. There are thousands of patients who suffer from spinal cord injury each year. If this method is effective, then it is a big blockbuster.” The approval, which is world’s first clinical trial of a human embryonic stem cell therapy, is likely to break the logjam for other trials of drugs and therapies derived from human embryonic stem cells, believe industry observers. Some of the therapies currently on the horizon target diabetes, Parkinson’s disease, cardiac disease, eye disorders and even production of blood. Dr Totey says, “The announcement is the biggest boost to all other human embryonic stem cell companies currently operating in various countries. However, it will not lead to sudden expansion of funding, as the recent ruling by US district court overruling Obama’s stem cell policy, may considerably jeopardize several stem cell projects around the globe.” There are not many clinical trials using human embryonic stem cells, waiting FDA nod. Very few companies are working on human embryonic stem cells, he adds. Dr Abraham believes that if the present trial continues with safety, at least with some efficacy in human patients, definitely it will have many followers. The issue of embryonic stem (ES) cells depends on the religious and socio-cultural beliefs of the society, and therefore, varies with religions and territories. Dr Abraham says, “Personally, I would say, we have to move forward. In case of IVF, the redundant embryos are destroyed, which I think, should be made available for research and clinical studies, with appropriate consent from all people involved in it.” NCRM presently is not working in the area of embryonic stem cell. But in the long term, plans to start work on iPS cells, because it is free from controversies, like the ES cells. There are a few groups working on human embryonic stem cells in India, but none of them are in clinical trial or therapy. They are all working on the very preliminary and primitive basic research. Dr Totey says, “We do not have ES cell lines in India, which is clinically eligible. I do not see any near future of human embryonic stem cells in India, especially for clinical application for a variety of reasons.” He points out that India does not have the technology of differentiation of ES cells into specific lineage, or proper ES cell lines that are clinically eligible, and can be used in humans. All the cell lines available are for laboratory use. The other point to note here is that, the country does not have large scale expansion methods for industries. No industry or institute is currently working in this area. The other concern is, the product may be very expensive and out of reach of the common man, as the entire procedure and protocol is very lengthy and time consuming. Adult stem cell therapy may be cheaper. Dr Totey suggests, “The only way to get such a product is to buy readymade technology, or wait for other companies to open their shop, or have industry collaborations or joint venture.” There are five to seven biotechnology companies currently developing stem cell therapies in India including Reliance Life Sciences and Stempeutics. Other prominent institutions such as the National Center for Cell Science and Ruby Hall Medical Research Center both in Pune and the Indian Institute of Science, Bangalore, besides Asian Heart Institute and Research Center and the Maulana Azad Medical College both in New Delhi are among 15 organizations working on stem cell projects. They use both adult stem cells, embryonic stem cells and also more readily available sources such as bone marrow, peripheral blood and umbilical cord blood cells, to find possible cures for many incurable diseases. The extent to which hESC will actually be able to treat a disease is still unknown. It may take a few  years to know the full-efficacy of this therapy. There is still a long way ahead. At least one hurdle, and the major one, is now over with the FDA approval. Quotes                                                       “This FDA approval is an excellent development and was long overdue. Geron has an excellent safety and preclinical data on spinal cord injury. This is one area where all other adult stem cells have miserably failed” —Dr Satish Totey, president of Advanced Neuro-Science Allies, Bangalore “The study using embryonic stem cell-derived product should go forward, particularly in conditions like spinal cord injury, where there are no definitive treatments.” —Dr Samuel JK Abraham, director, Nichi-In Center for Regenerative Medicine, Chennai ]]> <![CDATA[Recombinant vaccine is the next big thing]]> https://biospectrumindia.com/news/95/2726/recombinant-vaccine-is-the-next-big-thing.html https://biospectrumindia.com/news/95/2726/recombinant-vaccine-is-the-next-big-thing.html Wed, 08 Sep 2010 11:02:00 +0530 In continuation with our special series on CSOs, we bring yet another achiever in the field of biotechnology, Dr Venkata Ramana who is the Research Director, Reliance Life Sciences, an expert in vaccines and recombinant proteins. The recombinant protein area is one of the promising areas for the future. Researchers believe that recombinant vaccines could be the answer to many potential diseases. In India, for the last 10 years, Dr Venkata Ramana has been working with Reliance Life Sciences (RLS) in the areas of recombinant proteins, therapeutic monoclonal antibodies, siRNA-based drugs and therapeutic fusion proteins. Early years Dr Venkata Ramana began his career in microbial fermentation research under the guidance of Prof. NG Karanth and had a chance to apply chemical engineering principles to biology. After completing PhD in biochemistry from Central Food and Technology Research Institute (CFTRI), Mysore, he went to University College London (UCL), London, UK, and worked in the area of organic biocatalysis where his interest was to study the properties of enzymes isolated from thermostable microorganisms, and their action in organic solvents. He worked for three years at UCL before returning to India. On his return, he joined Shantha Biotech and worked for seven years on various projects including Shantha’s most productive project, the development of recombinant hepatitis B vaccine. Activities at Reliance Currently Dr Ramana is involved in a number of projects at Reliance. There are many biosimilar recombinant proteins and monoclonal antibodies, that are in various stages of development. Commenting on this, Dr Ramana said, “The siRNA is one of the focus areas for Reliance Life Sciences. We are evaluating a number of anti-viral and anti-cancer siRNAs in in-vitro and animal models.  Research on novel monoclonal antibodies and fusion proteins is underway for a number of indications.” “Reliance Life Sciences is a research-driven, biotechnology-led, life sciences organization. The company focuses on key areas such as medical, plant and industrial biotechnology. The company gives emphasis to biopharmaceuticals, pharmaceuticals, clinical research services, regenerative medicine, molecular medicine, novel therapeutics, biofuels, plant biotechnology and industrial biotechnology,” adds Dr  Ramana. RLS has the largest biosimilars pipeline in the industry. Regarding the product launches, he says, “The company has launched four biosimilars in the market – ReliFeron (Recombinant Interferon α) ReliPoietin (Recombinant Erythropoietin), ReliGrast (Recombinant Granulocyte colony stimulating factor) and MIRel (Recombinant Reteplase - tissue plasminogen activator).” Dr Ramana firmly believes that there are very good opportunities in the area of recombinant proteins. Commenting on the future, he says, “In the area of recombinant proteins, we can expect modified versions. They could be PEGylated, fused to other proteins and mutagenized at various sites, thus exhibiting better phamacokinetic and pharmacodynamic properties. We can also expect natural proteins expressed as recombinant proteins. In the area of vaccines, we will see vaccines developed based on proteomics approach and which elicit T-cell response.” Innovation drives growth According to Dr Ramana, the Indian biotechnology industry has made impressive progress in the area of vaccines and it constitutes a significant amount of exports. He says, “The industry is also trying to replicate such a success story in the area of biopharmaceuticals with substantial investment in research and facilities.” The Indian industry has to watch the regulatory environment both in India and outside. He adds, “Meeting the requirements of new guidelines would require completely new mindset from quality standpoint and manufacturing practices. The industry also needs trained manpower to meet these challenges.” Dr Ramana puts innovation as the key to the success of the biotechnology industry. “While laying stress on the innovation for growth, we need to embrace new technologies in the area of discovery and delivery. Collaboration with institutes and academics is a very important piece in the puzzle of innovation. Also, venture capital funding for testing proof-of-concept would expedite discovery, which would catapult industry to the next level pretty much the way it happened and is still happening in the Western world,” shares Dr Ramana. Inspiring factors Dr Ramana is a firm believer of team work. Speaking on his achievements, he says, “Instead of calling them my achievements, I would call it the achievements of the teams I have worked with. My training in CFTRI and UCL have paved the way for my work on projects like hepatitis B vaccine and interferon alpha at Shantha Biotech. In Reliance Life Sciences, my team worked on a number of projects, which has resulted in commercialization of five recombinant proteins and  other projects.” Dr Ramana who believes that if not a researcher, he would have been a teacher. “I think the passion and commitment of the companies that I worked with to develop much-needed life saving drugs is the inspiration,” he shares. Dr Ramana also feels fortunate to have good friends who constantly inspire him. While crediting his friends and family for his success, while praising his mentor, he observes, “I consider my PhD supervisor, Prof. Karanth as my mentor. From him, I learnt not only about practicing science, but also basic ethos of life.” As India moves ahead towards new technological revolution in next decade, it is the efforts of scientists like Dr Venkata Ramana that can play an important role in creating new opportunities in biotechnology area to tackle the various problems of mankind. ]]> <![CDATA[CDSCO to set up pharma zones at airports]]> https://biospectrumindia.com/news/95/2228/cdsco-to-set-up-pharma-zones-at-airports.html https://biospectrumindia.com/news/95/2228/cdsco-to-set-up-pharma-zones-at-airports.html Wed, 08 Sep 2010 10:58:00 +0530 The Central Drugs Standard Control Organization (CDSCO) of India will set up dedicated temperature and atmosphere-controlled areas at airport terminals in India, to maintain the safety, efficacy, and quality of imported and exported drugs and pharma products, in line with the product requirements and  good manufacturing practice (GMP) compliance, within the cargo premises of the airports. The Drugs Controller General of India (DCGI) Dr Surinder Singh, said, “We have a budget of 25 crore for this initiative, and the first pharma zone will be set up at the Indira Gandhi International Airport (IGIA), New Delhi.” Other terminals where similar pharma zones will be established, once initiated in New Delhi, include all the five international airports in India, plus the Nhava Sheva seaport. These pharma zones have been set up in the light of the increasing volumes of export and import of drugs from the country over the years. The CDSCO zeroed in on New Delhi to establish its first pharma zone, primarily because of the increased number of new pharmaceutical companies mushrooming in north India, due to the government policy initiatives excise/ income tax incentives. The current drugs exports from India is projected at 42,000 crore. India’s pharmaceutical exports mainly comprise of formulations (over 55 percent) followed by bulk drugs (43 percent) and the remaining comprises of herbal exports. Proposed US law may hit Indian exporters The proposed Foreign Manufacturers Legal Accountability Act of 2010 (FMLAA) seeks to protect US consumers by requiring foreign manufacturers and producers to take direct responsibility on any liability arising out of such manufacturers’ or producers’ products. Expressing disappointment at yet another protectionist measure emanating from the US, Chandrajit Banerjee, director general, Confederation of Indian Industry (CII), New Delhi said, “CII’s preliminary estimates suggest that the additional cost of compliance with this new US law for Indian companies could be anywhere between 1,393 to 2,318 crore ($300 to $500 mn). This would significantly impact the competitiveness of Indian exports”. The act requires all foreign manufacturers exporting packaged products (that includes drugs, devices, cosmetics, biological products, consumer products, chemical substances, new chemical substances and pesticides, to establish a registered agent in the US, who would be in a position to take legal responsibility for the liabilities arising out of these products, thus also bringing Indian exporters into the ambit of US jurisdiction. The FMLAA would prove to be very expensive for Indian exporters, especially for small and medium scale manufacturers and producers. For one, the cost of hiring registered agents on a permanent basis will prove prohibitive. Such a provision would be unjustified because many Indian exporters do not export to the US all year round; some, not even every year. This proposed law is also of grave concern because it applies not just to finished products, but also to intermediates. Government to initiate inspection of clinical trial sites The Drugs Controller General of India (DCGI) announced that India is soon to commence regular and on-the-spot inspections of clinical trial sites to ensure transparency and volunteer safety in the country. This could perhaps change the landscape of the clinical trial industry in India, which has been beset with lapses in adherence to safety guidelines. Dr Surinder Singh, DCGI, said, “This will commence in September and we will begin by inspecting trial sites in Bangalore, Mumbai, Kolkata, Chennai and New Delhi. This will not just strengthen the clinical trial scenario in India, but also ensure that volunteers are in safe hands and there are no violations in protocols”. For this, there will be a collaboration with the US Food and Drug Administration, in terms of training of inspectors. “Altogether, we have 169 inspectors. Out of this, 25 inspectors have  been trained already, and 20 more will be trained to audit these sites,” said Dr Singh. In terms of conducting clinical trials, there have been a number of loopholes in India, volunteer safety being one of them. Off late, a number of big pharmaceutical companies have been conducting trials in India, without being reviewed by the Ethics Committee. In April 2010, the Indian government suspended trials in Indian States for Merck’s cervical cancer vaccine, Gardasil, after reports of the vaccine being allegedly tested on children, before being tested on adults. This is how, putting in place a system of stringent checks and balances becomes imperative. ]]> <![CDATA[DA Prasanna becomes CMD of Manipal Acunova]]> https://biospectrumindia.com/news/95/2230/da-prasanna-becomes-cmd-of-manipal-acunova.html https://biospectrumindia.com/news/95/2230/da-prasanna-becomes-cmd-of-manipal-acunova.html Wed, 08 Sep 2010 10:56:00 +0530 DA Prasanna has taken charge as chairman and managing director (CMD) of Bangalore-based Manipal Acunova Limited, the subsidiary of Ecron Acunova GmbH and Acunova Life Sciences. He was formerly vice chairman of the company, and has been handed the reigns of chairmanship from Dr Ramdas Pai. Commenting on the development, Dr Pai said, “In the last five years, Manipal Acunova has grown from a start-up to a successful and stable CRO. Starting services as a clinical trials lab in 2005 and Bio Availability/Bio Equivalence (BA/BE) services in our cancer hospital, the company has grown its services in India, established presence in Europe, and has gained reputation for its quality of services.” Manipal Acunova is a CRO founded by Prasanna and Manipal Group, offers clinical research services to pharmaceutical, biotech, nutritional, device and medical diagnostic companies. Lupin appoints Paul McGarty as president Lupin has appointed Paul McGarty as president of its US subsidiary, Lupin Pharmaceuticals. He has over 25 years of experience in the pharma industry.  Most recently, as the CEO of Nycomed US, he successfully transformed the company into a dermatology specialty company with a generic business. Avesthagen appoints Sudhir Kant as COO Sudhir Kant has been appointed as the new chief operating officer (COO) of Avesthagen, an integrated systems biology platform company in India. For the past 25 years, he has worked for US biosupplier company, Millipore, and was heading the company’s Indian operations, as president, since the year 2000. Atul Sobti steps down as CEO, MD of Ranbaxy Atul Sobti, CEO and managing director of Ranbaxy, has resigned from his posts, with effect from August 19, 2010. Arun Sawhney, president, Global Pharmaceutical Business, Ranbaxy, has been appointed as the new managing director of the company, effective from August 20, 2010. Furthermore, the board of the company expressed its appreciation to Sobti’s efforts during his tenure as CEO and MD, and also for building upon the strong legacy of Ranbaxy as a premier global company. Sawhney, has over three decades of global experience with leading Indian and global pharmaceutical companies, and has held the role of president of Global Pharmaceuticals Business, at Ranbaxy, since January 2010. ]]> <![CDATA[Superbugs boost phage therapy]]> https://biospectrumindia.com/news/95/5402/superbugs-boost-phage-therapy.html https://biospectrumindia.com/news/95/5402/superbugs-boost-phage-therapy.html Wed, 08 Sep 2010 10:50:00 +0530 An unexpected consequence of the recent discovery of “superbugs”, resistant to all known and most powerful antibiotic drugs, is the keen interest in alternatives. One of the beneficiaries of this global attention on antibiotic resistance is the renewed interest in a forgotten or neglected phage therapies. For more than a decade, Bangalore-based GangaGen Biotechnologies, founded by former head of AstraZeneca India Research, Dr J Ramachandran, has been at the forefront developing effective treatments to antibiotic resistant bacterial infections using phage therapies. GangaGen’s researchers have crossed the first hurdle in using viruses (phages) that attack only harmful bacteria to develop a drug to tame a wide variety of bugs. Prior to the discovery of the world’s first antibiotic, penicillin by Alexander Fleming in 1928, doctors in many parts of the world used phages. The wonder drug, penicillin, and other modern antibiotics relegated phage therapies to the background. However, GangaGen team has developed the world’s first phage-based drug (not just a therapy), and human clinical trials of StaphTAME, which has shown effectiveness against the most widely prevalent bacterial infections caused in hospitals. US regulator, FDA, has already given the go ahead for the clinical trials of StaphTAME. GangaGen is among the less than dozen companies worldwide, whose work on developing alternatives to antibiotics are key to safeguarding our health in the coming decades. While Dr Ramachandran’s zeal is helping to make some progress against “superbugs”,  the nation’s health authorities are not so pro-active in developing a concerted plan to develop alternatives to antibiotics. Phage therapy had its beginnings in India, when in the late 19th century, a Canadian scientist noticed the anti-bacterial action in stored water drawn from the river Ganga. Yet, currently there is only a small research group, of Prof Gopal Nath and Prof. Anil Tripathi at the Benaras Hindu University in Uttar Pradesh and Prof P K Yadav at Jawaharlal Nehru University, New Delhi, working actively on phage therapies. This group has got a small funding of  21 lakh from  the Department of Biotechnology (DBT). Preliminary results from their studies indicate successful treatments using phage-based products against some bacteria. This BHU-JNU research group as well as GangaGen are starved of funds to widen their scope of  research. In fact, Dr Ramachandran indicated that if more funds are available, it would be possible to speed up product development so that effective treatments are ready if “super bugs” go out of control in the near future. Instead of getting worked up over the naming of one of the recent “superbugs” as “New Delhi (NDM-1)”, our government should formulate a National Plan to speed up research on phage therapy, and any other suitable alternatives available to tackle growing antibiotic resistance. A 500 crore National Phage Therapy Action Plan could be a good starting point if the Manmohan Singh government is seriously concerned about the health of India’s future generations. Meanwhile, things are beginning to look up for the battered BioAgri industry. Even as the minister-induced moratorium on Bt brinjal crop continues, the Genetic Engineering Appraisal Committee (GEAC) has approved the field trials of two new transgenic cotton crops developed by Dow Agrosciences and JK Agrigentics, incorporating new cry1Ac and Cry 1EC genes. More significantly, Syngenta Biosciences has been asked to start field trials of its genetically modified (GM) corn variety containing cry 1AB genes. This is definitely a step forward in pursuing the larger national goal of tapping biotechnologies for food security. This September issue of BioSpectrum has extensive coverage of the CRO industry which is playing an important role in the development of tomorrow’s drugs. India’s decision to set up a National Clinical Trials Registry is also a welcome step to ensure better monitoring of trials and it will go a long way in increasing public confidence in this industry. Group Editor <sureshn@cybermedia.co.in> ]]> <![CDATA[US-India BioPharma & Healthcare Summit 2010]]> https://biospectrumindia.com/news/95/2181/us-india-biopharma-healthcare-summit-2010.html https://biospectrumindia.com/news/95/2181/us-india-biopharma-healthcare-summit-2010.html Thu, 05 Aug 2010 17:23:00 +0530 US-India BioPharma & Healthcare Summit 2010 organized by the USA-India Chamber of Commerce in Boston attracted over 350 senior Biopharma executives, investors and academic leaders. The annual summit has become the “The Biopharma” event in the world for senior R&D involved with drug discovery and development. ]]> <![CDATA[GVK Biosciences receives AAALAC accreditation for its animal facility]]> https://biospectrumindia.com/news/95/1271/gvk-biosciences-receives-aaalac-accreditation-for-its-animal-facility.html https://biospectrumindia.com/news/95/1271/gvk-biosciences-receives-aaalac-accreditation-for-its-animal-facility.html Thu, 05 Aug 2010 17:22:00 +0530 GVK Biosciences (GVK BIO), one of the leading contract research organizations in Asia, has received full-accreditation from the Association for the Assessment and Accreditation of Laboratory Animal Care (AAALAC) International, a private, non-profit organization that promotes the humane treatment of animals in science through voluntary accreditation and assessment program, for its animal facilities. The accreditation demonstrates GVK BIO’s commitment to high standards of animal care. AAALAC commended the organization for promoting a productive research environment that ensured high standards of humane care and use of research animals. “It is indeed a proud moment for us. The AAALAC certification reiterates the fact that the team at GVK BIO is par excellent and provides high-quality drug R&D services to its clients in a regulatory-compliant environment,” said Dr JB Gupta, senior vice president for collaborative research and biology, GVK BIO. The AAALAC certification will help in furthering GVK BIO’s growth in the areas of pharmacology, ADME/DMPK, exploratory toxicology and animal models. GVK BIO is the first organization in Hyderabad, and only the sixth one in India to receive AAALAC certification. The endorsement is a validation of GVK BIO’s abilities to deliver world-class solutions. Karmic Lifesciences opens new CRO facility in Mumbai Karmic Lifesciences, a Mumbai-based contract research organization, has announced the opening of its new state-of-the-art 12,000 sq.ft. CRO facility at Airoli SEZ, Navi Mumbai. The new facility has state-of-the-art facilities including fully-secure, biometrics access, fire-proof, humidity-controlled central archival room, an investigational product storage facility with up to -80º C ambient temperatures, high-end rack servers, secure firewall and dedicated VPN connectivity. The inauguration was attended by over 200 guests including key industry stakeholders from Indian Drug Manufacturers’ Association (IDMA) and Organization of Pharmaceutical Producers of India (OPPI), as well as several pharma companies, investigators and academicians. As one of India’s fastest growing CROs, it was the next logical step for Karmic to move to a much larger facility and Karmic views this event as a major element in strengthening its positioning for global clients including the US and Europe. Nidhi Saxena, founder and CEO of Karmic Lifesciences, said, “The new facility is a step towards getting to best-in-class and will help us showcase ourselves as a technology-savvy CRO and ensure full-compliance to US FDA and 21 CFR Part 11 standards. We will further be going in for ISO 27001 (BS7799) certification shortly and will provide platinum standard data security to our global clients. This move comes up with several other initiatives we have embarked upon since we raised capital earlier this year including strengthening the team, enhancing oncology trial capabilities, developing a low-cost EDC solution, setting up a preferred site network on a pan-India basis and setting up a full-fledged sales operation in the US.” Dr Shreekant Sapatnekar, medical director and COO, Karmic Lifesciences, said “This is our moment of pride and takes us to a different league from an operational and IT capability perspective. Apart from expanding our overall operations, this move will give a strong fill-up to our formidable clinical data management capability and establish us as one of the CDM leaders from India. Veeda gains 39.57 cr from new biz Veeda Oncology, a full-service oncology CRO with facilities in North America, Europe and India, has been awarded over 39.57 cr ($8.4 mn) of new clinical research programs over the past 30 days. The awarded work will be conducted in India, Europe and the US and will include services for monitoring, data management and biostatistics, medical monitoring, safety, site management and project management. Matt Bowman, president and CEO, Veeda Oncology, said, “We are enjoying our continued repeat business from our existing clients as well as from new clients”. Veeda Oncology is part of Veeda Group, the largest phase I CRO in India also engaged in early clinical development and phase IIa clinical research since 2005. ]]> <![CDATA[DBT calls for MDR tuberculosis diagnostic research initiatives]]> https://biospectrumindia.com/news/95/2863/dbt-calls-for-mdr-tuberculosis-diagnostic-research-initiatives.html https://biospectrumindia.com/news/95/2863/dbt-calls-for-mdr-tuberculosis-diagnostic-research-initiatives.html Thu, 05 Aug 2010 17:20:00 +0530 In an endeavor to develop new and evaluate the existing diagnostic tools, imaging or therapeutics in clinical or population settings, the Department of Biotechnology (DBT), Government of India, has invited the research proposals for early and accurate diagnosis of active, latent and MDR tuberculosis. DBT expects industry, academia, and non-governmental organizations, individually or in consortium to participate in its efforts to develop the accurate diagnostic technology. The proposals must directly aim at providing them at the primary care clinic level preferably under a program like Revised National TB Control Program (RNTCP). The grants will support critically needed equipments, consumables, personnel and contingency expenses. The duration of the proposal may be of two to three years. The expected performance characteristics of point-of-care (POC) diagnostics have been fixed and these include the requirements such as higher specificity and sensitivity than the existing tests, readable results within four to six hours, specimen processing rate of 20 tests/day. The specimen options should have varied-sputum, blood, urine, saliva, CSF and tissues, and the technology should be self-contained, portable, battery-operated with option for charging and requisite minimum maintenance. The shelf-life is expected to be at least 24 months at temperature below 35°C and in varied humidity conditions and be cost-effective at the same time. Also, the duration of training has been fixed as two to three days for a field-based health worker. In addition to that, DBT has also invited proposals for two diagnostic tools that are already in use in other parts of the world to be made indigenously under ‘Import Substitution Package’. One is real-time PCR for rapid diagnosis of tuberculosis and MDR-TB using technologies like molecular, real-time nucleic acid amplification (NAA). The other is Line Probe Assay (LPA) for rapid diagnosis of MDR-TB using technologies like polymerase chain reaction and reverse line probe hybridization with mutation-specific labeled probes. Under this category, DBT is looking for industrial partners and academia to take up the technology challenges in making self-contained kit/device or one/multiple component/s of the two devices with willingness to license/commercialize the product, making it available in Indian/outside markets as an affordable one. The last date for sending the proposals has been kept as August 31, 2010. Nanotech R&D grows in personal care industry    Small particles are becoming a big business for the world’s personal care products manufacturers according to an analysis of world patent activity published by the IP solutions business of Thomson Reuters. The new report, ‘Can Nanotech Unlock the Fountain of Youth?’, finds that the beauty industry has begun to make an aggressive foray into nanotechnology, using tiny molecular compounds to improve the performance of creams, sunscreens, shampoos and other personal-care products. The report tracks unique inventions published in patent applications and granted patents from 2003 to 2009, along with trademark data from 2000 through to 2009, to identify the companies and areas of nanotechnology innovation showing the sharpest growth in this industry. The global study shows expansion in nanotech-based personal care products and brands with Japan, China and Korea as key growth markets. The study finds that the growth of nanotech is getting accelerated. The volume of innovative patents involving nanotech in beauty and personal-care items grew by 103 percent over the last seven years, more than doubling from 181 patents in 2003 to 367 in 2009. ]]> <![CDATA[India biopharma will be $200 billion; industry by 2020]]> https://biospectrumindia.com/news/95/7192/india-biopharma-will-be-200-billion-industry-by-2020.html https://biospectrumindia.com/news/95/7192/india-biopharma-will-be-200-billion-industry-by-2020.html Thu, 05 Aug 2010 17:18:00 +0530 The biopharma market in India is growing at an annual growth rate of 15 percent. By 2020, the market is projected to be worth over 938,688 cr ($200 bn), driven largely by a shift in usage from conventional drugs to biopharma products, the relatively high cost of biopharma products, the launch of biosimilars and a new generation of biotherapeutics. This was stated by Ashok Kumar, secretary, Department of Pharmaceuticals, Ministry of Chemicals and Fertilisers, Government of India, while inaugurating the National Convention on Biopharma, organized by the Department of Pharmaceuticals (DoP) and Federation of Indian Chambers of Commerce and Industries (FICCI) in association with the Department of Biotechnology (DBT) and the Association of Biotechnology Led Enterprises (ABLE) in New Delhi on July 12, 2010. On the occasion, Ashok Kumar released the 'Vision 2020' document titled 'Leadership in Affordable Therapeutic Products: A BioPharma Strategy for India', prepared by PricewaterhouseCoopers and ABLE. The report has exclusively quoted the BioSpectrum-ABLE Top 20 Biotech Survey, which was published in the June 2010 issue of BioSpectrum magazine. The report has used BioSpectrum data for providing the information on overall market size, rankings of the companies and other relevant figures. The 'Vision 2020' document spells out the challenges before the biopharma industry and suggests key action areas for the medium-term and long-term. The report states that if India wants to become the world leading provider of affordable biopharma products by 2020, it cannot simply count on biosimilars and vaccines; it should also become a source of innovation. More specifically, it should aim to have at least 10 original biologics on the local market and at least two on the global market by 2020. The report identifies five long-term (2020) initiatives and recommends that the government should make an additional 4,694 crore ($1 bn) fund available over the next 10 years to facilitate the growth. Ashok Kumar said, â€œThe Government proposes to set up a 3,000 cr venture capital fund for giving a fillip to drug discovery and strengthening the pharma infrastructure in the country. The National Institute of Public Finance and Policy (NIPFP) is set to finalize the bid document and the expression of interest for setting up the fund will be issued this month.â€? He further added that the government had issued an expression of interest for technical and financial bids for the selection of a global level consultant (GLC) for preparation of a detailed project report (DPR) for developing India as a drug discovery and pharma innovation hub by 2020. He said that the government is willing to look at the industry's demand for a single regulatory authority to do away with multiple regulatory bodies. At the same time, priority was being accorded to building the capacity of IP offices for approval and rejection of patents. He emphasized the need to create a talent pool of graduates in the biopharma sector, for which short-term courses that expose the graduates to the realities of the workplace, could be started by the National Institute of Pharmaceutical Education & Research (NIPER). Dr S Natesh, additional secretary, Department of Biotechnology (DBT), highlighted that India needs to move from a phase of manufacturing to path of discovery and innovation. Dr TS Rao, advisor of DBT highlighted the lack of availability of GCP-trained manpower in healthcare sector. He raised concern for the proper utilization of the already existing facilities set up by government and cautioned that careful need assessment is required for facilities to be effective. Distinguished persons from the industry and academia participated in the event. The convention had different sessions on manufacturing, infrastructure and HRD, challenges and opportunities in biopharma industry and also a session on the regulations for biopharma industry. Agricultural scientists call for revoking moratorium on Bt brinjal A workshop for scientists titled, 'The impasse caused by the Bt brinjal moratorium', was organized by the Foundation for Biotechnology Awareness and Education (FBAE) on July 28, 2010, in New Delhi. As part of the workshop, there was an open discussion on the impact of Bt brinjal moratorium on R&D of genetically engineered crop in India and the need to revoke the moratorium. Prominent agri experts including Dr Shanthu Shantharam, executive director, Association of Biotechnology Led Enterprises (ABLE); Dr TM Manjunath, consultant of agribiotechnology and IPM, and former director, Monsanto Research Center; Prof C Kameshwar Rao, consultant-biotechnology and medicinal plants, Foundation for Biotechnology Awareness and Education; Dr P Balasubramanian, former head, Department of Biotechnology, Center for Plant Molecular Biology; and Dr Seetharam Annadana, technology lead -Vegetables, Syngenta India participated in the workshop. The workshop concluded that the Ministry of Environment and Forests (MoEF) was strongly influenced by those opposed to agricultural biotech than by credible, critical and balanced scientific judgments. There was a consensus among the scientists that the seven city public consultation by MoEF did not provide an adequate opportunity for the scientific community to voice its concerns. A petition to the ministries and concerned departments of the government was also drafted after considering the opinions of all the participants. The memorandum was submitted to Prime Minister, Ministries for Agriculture, Science and Technology, Human Resource Development, Environment and Forests, Health and Family Welfare, Commerce, and also the Indian Council for Agricultural Research, Department of Biotechnology, Department of Science and Technology, Department of Scientific and Industrial Research, Indian Council for Medical Research and Council for Scientific and Industrial Research. The scientists also called upon various government regulatory agencies to step in and support the demand of ending the moratorium at the earliest. They also emphasized on public awareness as an important aspect of the technology development. India contributes 20% to generics market Indian pharma market has registered 38,692 crore ($8.25 bn) in 2009 and has enjoyed double-digit growth in the past five years, peaking at 25 percent in 2007. The strong growth registered by the Indian economy has helped to drive its pharma market and industry. India's expanding middle class, with growing affordability and greater access to healthcare are the main drivers for the current growth of the industry and economy. As per PriceWaterhouseCoopers report, finished generics supplied from India account for 20 percent of the global generics market. It is estimated that 70 percent of the patients belong to 87 developing countries and received drugs produced in India and distributed by the UNICEF, International Dispensary Association, the Global Fund and the Clinton Foundation. Biocon signs supply pact with Optimer Biocon has signed a long-term agreement with US biopharma company, Optimer Pharmaceuticals, for the commercial manufacturing of active pharma ingredient, OPT 80. The drug is among a new class of macrocyclic antibiotics and is being developed by Optimer to treat serious colon infections such as Clostridium difficile infection and is expected to be commercialized soon. For the last five years, Biocon has been an important partner in Optimer's Opt 80 development program and will continue this relationship with the manufacturing and supply of this product once the drug gets the approval. Antibiotics market registers 3,250 cr Changing trends and development in healthcare infrastructure make way for wide range of new antibiotic entrants in the Indian pharma market. According to a report by Datamonitor titled, 'High-end antibiotics usage in India,' the market for high-end antibiotics in Indian hospitals registers 3,250 crore ($686 mn) in FY 2010, having shown an year-on-year growth of 49.8 percent. The market is estimated to grow to about 8,725 crore ($1,841 mn) by FY 2015, posting a CAGR of 21.8 percent. Datamonitor noted that as healthcare infrastructure improves in India and well-established hospital chains expand their presence across the country, the market for hospital antibiotics is likely to widen. Although the anti-bacterial market in India is currently dominated by generics, newer antibiotics are constantly being sought after. Serum launches indigenous intra-nasal swine flu vaccine Nasovac Serum Institute of India (SII), one of the largest vaccine manufacturers in India, has launched its indigenously developed intra-nasal H1N1 vaccine under the brand name Nasovac on July 14, 2010, in Mumbai. SII thus became the third manufacturer in the country to market vaccines against swine flu, the other two companies being Zydus Cadila (VaxiFlu-S) and Sanofi-aventis (whose vaccines were imported by the Indian government). Speaking at the launch of the product Adar Poonawalla, executive director of SII, said, â€œThe fear of the public about the pandemic last year was a challenge for our healthcare system. In India, there are around 150,000 child deaths due to vaccine preventable diseases. According to the World Health Organization (WHO), even the African nations and other third world countries have better immunization programs than India. The Government of India and the Ministry of Healthcare attribute this to lack of resources and funds. India as a nation is not bothered about healthcare.â€? A Live attenuated influenza vaccine (LAIV), Nasovac, is a single dose vaccine fitted at the top of the syringe and around 0.25 ml is to be administered in each nostril, mimicking the path followed by the virus to enter the body. The vial consists of five doses. Except for pregnant women, any individual above the age of three years can use this intra-nasal vaccine. On the other hand, an injectable vaccine can be administered only for individuals 18 years and above. LAIV has the upper hand over an inactivated-based vaccine in many respects. Dr Prasad Kulkarni, additional medical director of SII, said, â€œIn the case of a LAIV, the production capacity is 10 times higher than inactivated-based vaccines, making this suitable during the times of a pandemic. The production cost is much lower and this enables us to produce larger capacities of the vaccine. Plus the simplicity of the nasal route is an added benefit.â€? With the outbreak of swine flu pandemic last year, Serum Institute was one among the three Indian vaccine makers-along with Bharat Biotech and Panacea Biotec-provided with the swine flu virus strains by the WHO to develop the vaccine. It was indeed a battle against time for the team. A BioSafety Level 2 (BSL 2) facility was set up a few weeks post the outbreak was officially termed as a pandemic. The seed virus was supplied by the WHO to SII and phase I trials of the Nasovac was conducted on 50 healthy people, post approval by the Indian regulator, the Drug Controller General of India (DCGI), around 330 volunteers (both adults and children) were roped in for phase II trial. According to FDA norms, trials cannot be conducted on pregnant women, hence the vaccine was tested on pregnant rats to prove its safety and efficacy. The product is now priced at half the price of similar vaccines marketed by Indian and foreign companies. â€œThe price of a single dose of this vaccine will cost 160 ($3.42) and is now available at retail outlets across all cities in India. As of now, we will market the product in India,â€? said Poonawalla. The company is slated to receive the WHO pre-qualification in a few months, subsequent to which it intends to market the product in 100 countries. DBT all set to strengthen biotech R&D in NE states While initiating a special program for the north eastern states, the Department of Biotechnology (DBT), Government of India, has invited proposals in the field of basic and applied biotechnology from Indian scientists, working on a regular basis in universities, academic, medical or research institutions in any of the north eastern states of India in collaboration with scientists from other national institutions. The scientists should be working in any of the broad areas of health sciences, agricultural sciences, veterinary sciences, pharmaceutical sciences, biomedical engineering, bioinformatics, food and nutrition, healthcare including alternative medicine, nanotechnology and environmental biotechnology. The joint R&D programs may involve partners from recognized private institutions as well as NGOs. The program aims to help establish and strengthen R&D activities in the north eastern states like Arunachal Pradesh, Assam, Manipur, Meghalaya, Mizoram, Nagaland, Sikkim and Tripura; through joint ventures. The proposals will be evaluated by the committee of experts. The approved projects would be initially funded for a period of three years that may be extended based on the performance review. The information in the application should be clearly given in two parts - one, pertaining to the parent institution in the north eastern region and the other regarding the collaborating institutions. The last date for sending the proposals as per the DBT format has been kept as August 9, 2010. ]]> <![CDATA[Biotech education booms]]> https://biospectrumindia.com/news/95/2614/biotech-education-booms.html https://biospectrumindia.com/news/95/2614/biotech-education-booms.html Thu, 05 Aug 2010 17:15:00 +0530 On an early July morning, I got a call from a school student, Prithu Baruah, in a small town in Assam’s Jorhat district. He had just finished his schooling and was planning to enroll in a college. He had read a copy of BioSpectrum recently and he had made up his mind to become a biotechnologist. The telephone call was to get a copy of BioSpectrum’s Education and Career Resource Guide  (ECRG) and also get some insights about the biotech industry. I sent him a copy of the ECRG along with Life Sciences Resource Guide (LSRG) 2010 to give him a better idea about the industry. The copies, sent by “speed Post”, reached after seven days due to the remoteness of the location. He did not favor the soft copy of some of the relevant articles because the internet connection there is not very reliable and so was not much use to him. During the many conversations I had with him, I was impressed by his admiration for the biotech industry and his determination to be part of it. And he wanted the results of the BioSpectrum Top 20 Biotech Schools Survey 2010 to make up his mind. There are hundreds of thousands of students like Baruah across the country who are opting for a career in biotechnology after reading about the industry’s recent achievements. The results of the 6th BioSpectrum Top 20 Biotech Schools Survey is presented in this edition. One of the highlights of this year is our estimation of the biotech education market itself. With over 500 institutions, both in public and private domains, offering biotechnology-related courses at the graduate level (BTech), post-graduate degrees (MSc and MTech and higher education, the biotech education sector has become a very vibrant one. We have estimated that approximately 40,000  students joined biotechnology courses in 2009 (we have excluded the entire gamut of three-year graduate courses in biology offered in 6,000 colleges). Overall, there are over 150,000 students pursuing various biotech courses and they spent over 1,050 crore in fees in 2009. This is a conservative estimate as many private institutions are believed to be charging four to five times the average annual fee of  100,000 upfront to provide admission. The year 2009 was a subdued one due to the economic slowdown and hence such upfront payments could have been less. Also, the enrollment in 2009 was 15-20 percent lower than that in 2008 due to the uncertain economic conditions that prevailed last year. There is certainly a churn in the biotech education market. Due to the large number of unfilled seats last year, some prominent Bangalore-based institutions are planning to discontinue their biotech courses this year. At the same time, there are other educational groups, such as the Oxford College of Science in Bangalore, which are bulling on the sector and gearing up to meet the expected rush by investing in highly sophisticated modern facilities. More than half the students in almost all the prominent institutions in Bangalore and other southern cities are from the north, and north eastern parts of the country. Majority of the biotechnology courses are taught in institutions located in the southern states. But the top institutions, ranked by BioSpectrum, in both public and private sector are evenly distributed in the northern, southern and western parts of the country. The eastern region continues to show negligible interest in biotechnology. In fact, the No.1 private institution this time is Jaypee University of Information Technology based in Solan in Himachal Pradesh. The No.1 institution in the public arena is the Institute of Chemical Technology in Mumbai. This institution was earlier known as the Mumbai’s University’s Department of Chemical Technology. There is a huge demand for biotech courses is revealed by the fact that for every seat offered in the top public institutions, there are on an average 40 applications. The pent up demand for quality education in biotechnology is met by the nearly 400 institutions which have come up or started offering biotech courses in the last 10 years. Despite these huge numbers, the biotech and allied industries are in a position to absorb less than one-third of the students passing out each year. About 40 percent of the students go abroad to pursue higher studies and bulk of the remaining students are absorbed by the software industry. This is the something the biotech industry leaders and policy makers should analyze and formulate strategies to retain the biotech-friendly human resources. ]]> <![CDATA[Onboarding talent-Recruitment Scenario]]> https://biospectrumindia.com/news/95/5369/onboarding-talent-recruitment-scenario.html https://biospectrumindia.com/news/95/5369/onboarding-talent-recruitment-scenario.html Thu, 05 Aug 2010 17:02:00 +0530 With increase in competition and corporatization in the biotech space, HR heads are now on the look out for hiring not just good but the best young talent available in the country. BioSpectrum takes a look at some of the recruitment processes adopted by prominent biotech companies in India The success behind every company stems not just from its middle and senior  management employees, but from a large section of its Generation-Y populace, the ‘young turks’ as they are often referred to, who bring with them not just the technical expertise and much-needed  vigor, vibrancy and creativity. HR heads from the life sciences industries have realized that a radical transformation within their respective organizations can be attained only by hiring ‘not quantity but quality freshers’. They look for not just good performers but great performers. It is interesting to note that many companies in the life sciences space have gone the innovative way as far as talent acquisition is concerned. Recruitment process Indian CRAMS player, Jubiliant Drug Discovery and Development, follows a stringent process for selecting the talent pool that covers every aspect of technical knowledge and behavioral attributes. To ensure that they are making the right choices, the HR team initiates an interview process that spans for over two days and the aspirants are required to undergo various rounds of scientific and behavioral evaluation. Though the scientific interviews are straight-forward, the behavioral interviews test the rigor and mettle of each aspirant. Kankana Barua, vice president and global head – HR, Jubilant Drug Discovery and Development (DDDS), says, “Jubilant uses a culture fitment tool to ensure that each aspirant meets the threshold criteria to ensure a faster and smoother assimilation into the system of the organization. Jubilant has been actively involved in attracting talent from the renowned institutions across the country and is leveraging its presence in Noida and Bangalore to build deep relationships with premier institutes located in Northern and Southern parts of India in the scientific streams like chemistry, biotechnology and microbiology, clinical research, and pharmaceutical sciences.”  Rammesh Patiil, HR head, Serum Institute of India, says, “Pune is the educational hub of the country and meets 75 percent of our demands. Some of the colleges we visit include, DY Patil, College of Pharmacy and College of Engineering.” KV Subramaniam, president, Reliance Life Sciences, says, “Reliance Life Sciences provides young students with an opportunity to become part of the organization, on successful completion of the Advanced Diploma Programs conducted by our not-for-profit institution, Reliance Institute of Life Sciences.” New Delhi-based Panacea Biotec visits campuses such as Punjab University, Guru Nanak Dev University, and  Indian Institute of Packaging. Nuziveedu Seeds hires approximately 25 trainees every year and campuses of its focus are Osmania University, Andhra University, Badruka College, and National Institute of Agricultural Extension Management (MANAGE). Hyderabad-based Indian Immunologicals prefers to visit campuses across the country for scouting young talent. Similarly, the team at Eli Lilly travels across the country and recruits around 80 employees every year from premier pharmacy colleges and management institutes. Biotech companies now visit both  technical-oriented colleges and universities and also started visiting some of the premier management institutes in the country like the Indian Institute of Management (IIM) and Indian School of Business (ISB). “Agriculture is an upcoming sector in the country. Rural India is on the strategy cards for most of the companies. Plus, students these days look for challenging roles that will lead to better growth,” shares Atul Sharma, head – HR, Monsanto India. Sharma also believes that the MNC tag also helps in attracting talent due to the global opportunities that the company has to offer to the youngsters in terms of overseas placements and exchange programs. Monsanto in India primarily recruits Agriculture MBAs  for sales-related roles via campuses such as SIIB, MANAGE, NIAM and XIM-B. The company is also connected with agri universities like GB Pant University of Agriculture and Technology, Punjab Agricultural University, and GKVK-Bangalore. Biocon does campus interviews for both technical and managerial positions. Biocon focuses on technical campuses such as IIT; BITS, Pilani; NIPER;  and UICT; and management campuses like ISB, IIM Kolkata and XLRI. Expected qualities Domain-specific technical expertise is a criteria that HR heads look for in a post-graduate student  during campus placements. Commenting on this, Patiil says, “We require a lot of  freshers  from the technical field especially for our R&D department. We look at clarity and strong foundation in basic technical concepts in students.”  Every year, Serum hires around 80-100 students. Reliance Life Sciences follows a similar route. “We look at excellent academic track record, sound conceptual knowledge in the relevant domain and good analytical and communication skills,” says Subramaniam.  Technical expertise and managerial skills should also be counterbalanced with high energy levels and enthusiasm, passion, right attitude, motivation, learning agility, communication skills, customer focus, drive for results and team spirit.  Ravi C Dasgupta, group head—HR, Biocon, says, “At premier institutes one can take technical abilities as given. What we look for really is the right attitude and candidates with strong analytical, interpersonal and communication skills.” While recruiting a prospective candidate, vaccine major, Panacea Biotec, has divided its competency evaluation into two categories: manager and below positions (E-6-E-8 grades) and senior manager and above positions (E-5 and above grades). The HR team looks for a fresher with a performance focus, customer focus, creativity, strong communication skills and team work skills. Kallol Chakraborty, vice president – HR, Panacea Biotec, “In addition to all other skill sets, we also look at personality, family background, attitude/traits, domain knowledge, analytical abilities and emotional intelligence.” In India, the global agri-major, Monsanto look for freshers who are open to taking up cross functional challenges in the future. Sharma says, “We look for individuals with educational and technical skills; in addition to entrepreneurial skills, creativity, and team-orientation. The candidate should be capable of stimulating cross-functional challenges, and should also demonstrate the right cultural fit. A fresher might be given a particular function at the time of hiring but gradually as he grows in the company he might be given another job function.  Hence a student should be open to such added responsibilities..” Selection criteria Life sciences being a knowledge and technical-driven industry, students are put through  vigorous technical interview rounds, be it for companies in the biopharma, bio-agri or the CRAMS space. In addition to this, companies also evaluate behavioral skills and basic personality traits of a candidate. Monsanto India, has devised an interesting methodology. Sharma says, “Monsanto India has a behavioral interview assessment kit that provides behavior event interview questions as probes for the panel to understand the candidate in terms of values, respect, courage and business acumen. The panel usually comprises more than three interviewers who interact with the candidate to ensure the right cultural and functional fit.” Some companies are also adopting psychometric tests in its methodologies. Mahyco’s HR team has developed competency mapping, attitude tests and will introduce psychometric tests. Commenting on this, L Gaekwad, vice president – HR, Mahyco, says, “We have identified six competencies and we gauge competencies at two levels, one at the organizational level and other at the individual level.” Eli Lilly evaluates a candidate’s aptitude towards a job responsibility through Thomas Profiling. Under this, an interviewee has to tick the relevant answers on a questionnaire, a process that takes about 10 minutes. Based on the answers the strengths, skills, emotions and weaknesses of a person is evaluated. The results analyze individual’s skills and hints at whether the person is suitable for the specified job. “This apart, we also look at aspiration clarity, career and motivation perception, integrity and values, and persuasiveness,” says Sameer Bhariok, director – HR, Eli Lilly. Above all, companies look at the stability factor in students. HR heads unanimously opined that today, the average work term of a fresher in one company ranges anywhere between 2-5 years. After getting the requisite years of job experience, freshers either opt for pursuing their higher studies or move on to greener pastures. “We ask candidates upfront during the interview about their long-term plans to gauge their stability factor and surprisingly many of them have been upfront about their long-term plans,” adds Sharma.  Attrition Rate Company Attrition Rate Biocon 18.80% Monsanto India 11-12% Mahyco 9.50% Serum Institute of India 8-9% Indian Immunologicals 10.00% Do universities supply right  talent? Giving practical exposure to students is the dire need of the hour, claim industry experts. Subramaniam says, “A large number of universities and institutions have, over the last few years, introduced several programs in biotechnology and pharmaceutical domains to meet the growing talent requirements of the pharma and biotech industry. However, the curriculum lags behind in providing practical exposure to students.” Keeping this point in mind, Reliance Institute of Life Sciences aims to bridge this gap and equip students by providing them an insight into cutting-edge developments in the field of science and technology through an experienced faculty from the industry and a world-class set up at Dhirubhai Ambani Life Sciences Center, Mumbai. “There needs to be more emphasis on developing industry-relevant skills. Key gaps are felt in areas like bioprocess engineering and bioanalytical skills for biologicals,” observes Dasgupta. Another school of experts believe that the trend is gradually changing for  the better. “The trend is improving and encouraging. University curriculum constantly need to adapt with the changing environment, and when it lags, it indirectly puts pressure on the organization to provide fresh candidates with on-job training,” adds Sharma. In a nutshell, building strong knowledge foundation is what matters. “We invest our time in training these freshers and after six months, they give in good results. So, we cannot blame the university system of education,” concludes Patiil. Average Salary Packages Company Fresher Junior level (2-5 years experience) Middle level (5-10 years experience) Senior level (11-20 years experience) Management (21 years and above) BioPharma Companies 1.05 lakh per annum 1.50 to 4 lakhs per annum 4.00 to 7.00 lakhs per annum 7.00 to 18.00 lakhs per annum 18 to 32 lakhs per annum (excluding directors) BioAgri Companies 8,000 per month to 20,000 per month 15,000 per month to 25,000 per month 25,000 per month to 50,000 per month 50,000 per month to 3 lakh per month 2 lakh per month Vaccine Companies 1.75 lakh per annum 3- 4.5 lakh per annum 5-10 lakh per annum 10-25 lakh per annum Depends on seniority Nayantara Som Inputs: Rahul Koul & Jahanara Parveen ]]> <![CDATA[ICT, Mumbai emerges as India's No.1 BT School]]> https://biospectrumindia.com/news/95/1671/ict-mumbai-emerges-as-indias-no-1-bt-school.html https://biospectrumindia.com/news/95/1671/ict-mumbai-emerges-as-indias-no-1-bt-school.html Thu, 05 Aug 2010 16:56:00 +0530 Institute of Chemical Technology (ICT) from Mumbai moved up the ladder in the Public BioSpectrum BT School Ranking (Public) from last year's Rank No. 4. ICT also made it to No. 1 Rank on faculty parameter Delhi's prestigious JNU made it to Rank No. 2 BioSpectrum Top 20 Private Biotech Schools Rank Name of the Institute City, State Faculty Score Industry Interaction Score Infrastructure Score Placement Score Overall Score 1 Institute of Chemical Technology Mumbai, Maharashtra 89.33 40.50 47.19 23.41 100.00 2 School of Biotechnology, Jawaharlal Nehru University New Delhi 52.60 56.34 61.53 1.04 92.73 3 School of Life Sciences, University of Hyderabad Hyderabad, andhra Pradesh 40.37 39.92 45.11 29.75 74.61 4 University School of Biotechnology, Guru Gobind Singh Indraprastha University New Delhi 19.90 1.23 49.02 33.20 47.15 5 Animal Biotechnology Center, National Dairy Research Institute Karnal, Haryana 25.99 10.26 33.99 9.31 40.81 6 Center for Plant Molecular Biology, Tamil Nadu Agricultural University Coimbatore, Tamil Nadu 32.51 9.73 16.60 31.69 38.60 7 Department of Biotechnology, University of Kashmir Srinagar, Jammu & Kashmir 19.66 1.25 26.27 35.72 34.18 8 Department of Molecular Biology & Biotechnology, Tezpur University Sonitpur, Assam 24.73 10.65 15.66 11.27 29.99 9 Department of Biotechnology, Jamia Millia Islamia New Delhi 11.73 0.62 9.87 70.56 27.80 10 School of Biotechnology, Banaras Hindu University Varanasi, Uttar Pradesh 24.78 1.46 15.25 17.98 26.51 11 Department of Microbiology and Biotechnology, The Maharaja Sayajirao University of Baroda Vadodara, Gujarat 10.04 2.57 8.32 49.44 22.35 12 Department of Biotechnology, University of Jammu Jammu, Jammu & Kashmir 20.87 2.06 9.63 9.69 19.66 13 Department of Biotechnology, University of Pune Pune, Maharashtra 16.23 0.51 8.91 16.83 17.61 14 Department of Biotechnology, University of Burdwan Bardhaman, West Bengal 12.02 0.13 5.63 29.95 16.22 15 Department of Biotechnology, Shivaji University Kolhapur, Maharashtra 21.99 0.00 2.99 8.99 15.10 16 Department of Biotechnology, Cochin University of Science and Technology Cochin, Kerala 13.34 0.00 4.61 0.00 9.60 17 Department of Biotechnology, University School of Sciences, Gujarat University Ahmedabad, Gujarat 11.72 0.24 0.81 9.85 8.83 18 Department of Biotechnology, Kumaun University Nainital, Uttrakhand 8.55 0.00 6.47 0.62 8.36 19 School of Biotechnology, Guru Ghasidas Viswavidyalaya Bilaspur, Chhattisgarh 3.64 0.01 8.42 5.39 8.04 20 Department of Biotechnology, Himachal Pradesh University Shimla, Himachal Pradesh 6.00 1.80 0.00 0.00 4.02 Public BT Schools: Rajiv Gandhi Center for Biotechnology (Thiruvananthpuram, Kerala), Government Science College (Bangalore, Karnataka), Bangalore University (Bangalore), Aligarh Muslim University (Aligarh in Uttar Pradesh) and Kakatiya University (Warangal in andra Pradesh) did not participate in the 2010 survey due to on going admission processes, vacations and participation of teaching faculty in conferences.6th BioSpectrum Biotech Schools Survey 2010-Methodology The BioSpectrum Top Biotech Schools study includes institutions offering BTech, Masters and PhD courses but not of BSc courses. This study was conducted during May-July 2010. The ranking is based on measurable and quantifiable data. The research team did not seek perceptions and opinions of stakeholders such as students or industry to rank the institutes. BioSpectrum team sent questionnaires to over 200 institutes and followed up with them. We received about 50 questionnaires. Step - I: Identification of Parameters for Ranking of the Institutes Like the previous year's studies, the parameters suitable for ranking of the institutes were identified in consultation with experts from the industry, education and R&D. Over 10 experts were consulted. Faculty, industry interface, infrastructure and placements emerged as the most important parameters. Step-II: Ranking on the basis of the Parameters Structured questionnaire was used to take opinion on relative importance of the four parameters prior to the study. Their opinion was sought for deciding on weights to be assigned to each parameter. The following means emerged based on data received from experts: Faculty, infrastructure, and industry interaction had emerged as the three most important parameters ahead of placement. Step-III: Data collection, analysis and ranking of the institutes A pre-tested structured questionnaire was sent to Directors/ Principals/ Deans of Biotech institutes by the BioSpectrum team. BioSpectrum scrutinized and validated the responses given by the institutes for accuracy, consistency and sufficiency of the data, data entry, analysis of the data and ranking of the institutes. The research team spent considerable amount of time accurately analyzing the filled in data for each institute. For each institute, a score was arrived at for each parameter. For a particular parameter, the score was a composition of each of the sub-parameters. Faculty score of an institute would be composed of faculty per student, qualification of faculty members, research articles published, contribution of the faculty to national and international journals, patents filed and granted. Infrastructure score would be similarly composed of capital expenditure on lab equipment and consumables, expenditure on books and journals, and availability of dedicated and shared PCs per student. Similar scores were arrived at for industry interaction and placement using sub-parameters. Appropriate and largely consistent weights were used for sub-parameters wherever necessary. Sub-parameter scores were indexed with hundred points being granted to the institute with highest score for a particular sub-parameter. Indexed scores were than added up for each institute to arrive at the total score for a particular parameter. Scores were than averaged on hundred. Each of the parameters (faculty, infrastructure, industry interaction, and placements) was further weighed as per weights provided by experts to arrive at the total score of an institute. The institutes were then ranked as per this score on an overall basis. The ranking was done separately for the public and private institutes. Ranking Parameters Faculty: Faculty per student; faculty qualification; faculty experience; publications by the faculty in national and international journals at different points of time; and patents filed/granted both national and international at different points of time. Infrastructure: Expenditure on library; expenditure on lab equipment and consumables at different points of time; and labs per student. Industry Interaction: Products developed by the institute in production; projects sponsored to an institute from industry and government sources; and royalty inflow at different times. Placements: Visits of companies for campus recruitment; job offers during campus placement; number of students placed against needed; number of job offers against needed; and salary offered during the campus placement.Weights: Infrastructure-32; Faculty-28; Industry interaction-28; and Placement-12 BioSpectrum Biotech School Survey 2010 Ranking by Industry Interaction Ranking by Placement Score Ranking by Faculty Score Ranking by Infrastructure Score School of Biotechnology, Jawaharlal Nehru University from New Delhi ranked No. 1 on industry interactionand infrastructure parameter. The institute runs one the finest masters degree programs in biotechnology. Most of the post-graduate students opt for higher studies with only few students taking job opportunities with the industry. The school slipped to No. 2 spot in overall ranking on account of placement scores, since its students opt for higher studies. Public institutes offer course at affordable fees The private institutes that offer both under-graduate and post-graduate courses in biotechnology are charging an average fee of about 3,20,000 for the course. Whereas post graduate course in public sector institutes costs on an average 49,200 for the two year course. Some of the premier universities of the country such as Jawaharlal Nehru University are charging a meager fee of 1,391 for the entire course of two years. Similarly, other leading universities such as Cochin University of Science and Technology, MS University of Baroda, Banaras Hindu University are offering biotechnology courses to students at 6,190, 4,260 and 8,858 for the entire course. While private institutes such as Shree Manibhai Virani & Smt Navalben Virani Science College have been charging about 21,000 per annum. Sitadevi Ratanchand Nahar Adarsh College and Maharani Lakshmi Ammanni College for Women are offering biotechnology courses at 28,000 per annum. The biotech course at Gokaraju Rangaraju Institute of Engineering and Technology and Arunai Engineering College are being offered to students at 30,000 per annum and 32,500 per annum respectively. While other institutes in private sector are offering the course at higher fees of over 1 lakh per annum. ]]> <![CDATA[Jaypee pips SASTRA to become No.1; private school]]> https://biospectrumindia.com/news/95/1305/jaypee-pips-sastra-to-become-no-1-private-school.html https://biospectrumindia.com/news/95/1305/jaypee-pips-sastra-to-become-no-1-private-school.html Thu, 05 Aug 2010 16:52:00 +0530 BioSpectrum Top 20 Private Biotech Schools RANK Name of the Institute City Faculty Score Industry Interaction Score Infrastructure Score Placement Score Overall Score 1 Jaypee University of Information Technology Solan 55.48 49.61 51.84 16.89 100.00 2 SASTRA University Thanjavur 68.44 27.27 38.93 35.12 90.49 3 Amity Institute of Biotechnology Noida (UP) 69.91 2.91 43.52 20.11 76.45 4 Rashtreeya Vidyalaya College of Engineering Bangalore 25.98 8.93 53.02 29.36 63.00 5 Vidya Pratishthan's School of Biotechnology Baramati 10.78 61.00 21.35 8.13 58.08 6 Shoolini University of Biotechnology & Management Sciences Solan 25.41 28.59 16.17 42.49 52.86 7 Vellore Institute of Technology Vellore 42.99 14.81 10.36 41.63 50.98 8 KS Rangasamy College of Technology Namakkal 26.71 37.16 11.13 7.55 46.52 9 Shree Manibhai Virani & Smt Navalben Virani Science College Rajkot 12.98 1.47 20.06 72.61 39.92 10 Padmashree Group of Institutions Bangalore 11.42 32.62 16.52 5.01 37.92 11 Jaypee Institute of Information Technology Noida 37.53 2.24 15.92 9.42 36.13 12 The Oxford College of Science Bangalore 19.65 0.13 22.95 16.55 30.95 13 Jaipur National University Jaipur 26.67 3.41 15.79 9.93 30.53 14 The Oxford College of Engineering Bangalore 15.05 7.30 15.90 18.51 28.24 15 Bannari Amman Institute of Technology Sathyamangalam, Erode District 12.56 19.57 11.17 7.05 27.93 16 Gokaraju Rangaraju Institute of Engineering and Technology Hyderabad 8.68 26.91 7.72 7.97 27.87 17 Vydehi Institute of Biotech Science Bangalore 29.12 0.00 14.36 0.00 26.53 18 Reva Institute of Science & Management Bangalore 10.75 22.72 7.42 6.50 26.07 19 Maharani Lakshmi Ammanni College for Women Bangalore 27.10 0.22 11.07 4.24 24.36 20 Acharya Institute of Technology Bangalore 18.56 0.24 15.08 2.58 21.65 21 Acharya's Bangalore B-School Bangalore 19.69 1.56 8.46 13.31 21.35 22 Arunai Engineering College TamilNadu 15.67 0.93 11.26 3.76 18.11 23 T John Group of Institutes Bangalore 10.02 0.02 15.43 6.15 17.66 24 PES Institute of technology (PESIT) Bangalore 13.45 0.94 6.48 6.11 14.23 25 DR DY Patil Biotechnology & Bioinformatics Institiute Pune 14.00 0.00 5.06 1.92 12.01 26 Sitadevi Ratanchand Nahar Adarsh College Bangalore 7.38 0.00 5.93 14.81 11.95 27 Oxbridge College of Science & Commerce Bangalore 10.94 0.00 4.10 10.00 11.61 28 Dolphin Institute of Biomedical and Natural Sciences Dehra Dun 9.34 0.09 3.65 6.44 9.54 29 Dayananda Sagar Institution Bangalore 8.56 1.28 4.17 2.51 9.14 Private BT Schools: SRM University (Chennai in Tamil Nadu), Avinashilingam University for Women (Coimbatore in Tamil Nadu), Presidency College (Bangalore in Karnataka) and, Banasthali University (Tonk in Rajasthan) did not participate in the 2010 survey due to on going admission processes, vacations and participation of teaching faculty in conferences.BioSpectrum Biotech School Survey 2010 Ranking by Industry Interaction Ranking by Placement Score Ranking by Faculty Score Ranking by Infrastructure Score Four each from North and South based institutes ranked among the top 10 in the private BT schools in the 6th BioSpectrum Biotech School survey and remaining places went to institutes from West. Jaypee University of Information Technology (JUIT), Solan, has pushed down SASTRA University to the second position to gain the number one position in the private BT schools in the 6th BioSpectrum Biotech School survey. This institute came at third in the faculty, second position in industry interaction and infrastructure score to top the list of the private BT schools. SASTRA University from Thanjavur in Tamil Nadu that has been holding the top position for two consecutive years in the past stood second in this year's BT school survey. This institute stood second in faculty, fourth in infrastructure and placement scores. Amity Institute of Biotechnology (AIB) Noida moved up in the ranking list by one position from last year's fourth position to the third one. Because of this Jaypee Institute of Information Technology, which was at third position last year, moved down in the ranking. The institute topped the list in faculty score and stood third in the infrastructure score sheet. ]]> <![CDATA[Biotech Education Market in India garners over Rs 1,050 crore]]> https://biospectrumindia.com/news/95/7366/biotech-education-market-in-india-garners-over-rs-1050-crore.html https://biospectrumindia.com/news/95/7366/biotech-education-market-in-india-garners-over-rs-1050-crore.html Thu, 05 Aug 2010 16:47:00 +0530 380 120 1.15 Lakh Private institutes Public institutes Number of students The Biotech Education Market in India in 2009 wasworth 1,050.72 crore with over one lakh students studying in more than 500 institutes. According to BioSpectrum estimates, about 380 private institutes are offering under graduate, post graduate, MPhil and PhD courses and 120 public institutes are offering post graduate and PhD courses. The private institutions are collecting an average fee of 3.2 lakh per course per student except few institutions that are charging higher fees-in some cases over three times the average. While a student pursuing masters from a public institute pays just 49,200 for the two-year course, students opting to study biotechnology at private institutes pay as high as six-and-a-half times the fees the public institutes are charging, according to the results of the 6th BioSpectrum Top 20 BT Schools Survey. Forty nine public and private institutes actively participated in the 2010 survey. Some of the premier universities such as Jawaharlal Nehru University are charging a meager fee of 1,391 for the entire course of two-years. Similarly, other leading universities such as Cochin University of Science and Technology, MS University of Baroda, Banaras Hindu University are offering the biotechnology courses to students at 6,190, 4,260 and 8,858 for the entire course. The public universities are able to offer the biotechnology courses at an affordable fee to the students as these are receiving grants from different government agencies. In private institutes category, Shree Manibhai Virani & Smt Navalben Virani Science College has been charging about 21,000 per annum. Sitadevi Ratanchand Nahar Adarsh College and Maharani Lakshmi Ammanni College For Women are offering Biotechnology courses at 28,000 per annum. The Biotech course at Gokaraju Rangaraju Institute of Engineering and Technology and Arunai Engineering College is being offered to students at 30,000 per annum and 32,500 per annum respectively. While other institutes in private sector are offering the course at higher fees with over Rs one lakh per annum. These 49 institutes have 1,054 full time faculty of which 706 are PhDs holders. About 822 are teaching at the private institutes and 232 are teaching at the public institutes. The private institutions have published 459 papers in the national journals and 701 in international journals in the last three years. Similarly, the faculty at public institutes published 233 papers in national and 888 papers in the international journals in the 2007-2010 period. Faculty at the leading institutes such as Vellore Institute of Technology, SASTRA University and Jaypee University of the Information and Technology have published maximum number of papers during the period. Of the 49 institutes, 32 have conducted campus interviews. About 1,922 students got placed during the campus placements. Meanwhile, over 3,300 students expressed interest in continuing education and research in this space. The highest salary package offered to a BTech graduate was 4.8 lakh to a student from RV College of Engineering in Bangalore. The average annual highest package for a BTech student offered at the placement time was 3.82 lakh. For the post graduate student the average highest package offered was 3.16 lakh and lowest package offered was 1.94 lakh per annum. For a PhD holder average annual package offered by the companies was 6 lakh. Jawaharlal Nehru University (JNU) continue to remain a much-sought-after institute among students who are keen on joining courses in biotechnology. The JNU received over 2,500 applications for an intake of 8 PhD seats. Similarly University of Hyderabad and Institute of Chemical Technology, Mumbai attract a lot of attention among the students as these received 4,121 applications for 101 seats and 277 applications for 40 seats for post graduate courses. However, the question often raised by the industry is how employable is this talent pool. A lot can be done on this front in the general view. According to Dr Yogeshwar Rao, senior scientist, Indian Institute of Chemical Technology (IICT), Hyderabad. â€œThere is a need to create finishing schools as a part of existing research institutes. Often there are voices within the industry saying that these graduates are not employable. Therefore, we need 'advanced learning schools'. Persons trained in one particular area need to impart added skills in students.â€? â€œThe industry generally feels that the institutes are not creating the industry-oriented professionals. They might be right, but the universities generally don't expect their students to work directly in the industry after their post-graduation courses,â€? observes Dr Bhat. The business aspect of the biotech cannot be overlooked for long and it needs to be put in place at the right time. Otherwise, the whole industry is set to lose in the long run. There are two ways in which one can find solution for this. Those having a flair for corporate world should be given an opportunity in this industry and at the same time, the research-oriented students should get ample support to help them in their pursuit. In this regard, the segregation seems to be one of the keys. Sujay Shetty, associate director of pharma and life sciences, PricewaterhouseCoopers, India, says, â€œThere is a strong need for metrics in education. There is no dearth in courses and programs, but, we need to introspect on the quality of graduates we are creating.â€? The way forward The Department of Biotechnology, Government of India, is taking initiatives to bridge the gap between education and employment by remodeling the existing educational set up with emphasis on multidisciplinary research. The other government agencies such as the Department of Science and Technology, and the Indian Council of Medical Research are also taking steps to reform the education system. Dr TS Rao of the Department of Biotechnology, says, â€œDBT has been ensuring that there are changes in the educational system. We have been taking the multidisciplinary approach towards education. The work on translational research facilities at Faridabad Biocluster is one such initiative.â€? DBT intends to select two to three universities per year across the nation and then send a team to selected universities to undertake an analysis of strengths and weaknesses in infrastructure, inter-disciplinary research programs, skill and leadership gaps. Taking this initiative further, DBT has selected the Banaras Hindu University (BHU) and Osmania University for this program. The other universities included in the program are the state agricultural universities such as Punjab Agricultural University, Tamil Nadu Agricultural University, University of Agricultural Science-Dharwad, and G B Pant University of Agriculture and technology. As part of its long term approach, DBT is expected to cover about 30 universities by next 10 years. This is due to the fact that the process of negotiation and engagement is repetitive, serious and requires critical thinking. So, this time consuming process limits the ability to handle not more than three universities per year. In an interview published in Biotech News, Dr MK Bhan, secretary, DBT, has rightly put forward the strong need to change the thinking and attitude towards the universities and research institutes. While highlighting his point, he said, â€œGenerally the universities are considered only as education centers and the research institutes as centers for strategic or applied research. Therefore, the universities have not been given much attention in terms of funding and support. Universities lack adequate resources, effective leadership and good governance. In comparison to this, the research institutes have been able to attract good faculty due to more resources and adequate funding.â€? Recently, the DBT also invited letter of intent for upgradation, remodeling and creation of interdisciplinary program of life sciences (IPLS) for advanced research and education in Central/State universities. The specific objective is to upgrade the post graduate teaching and training laboratories in terms of infrastructure and equipment, appoint new faculty, provide fellowships for students, introduce training programs, regroup research activities in emerging areas along the biotech innovation chain (from discovery to market) and promote academia-industry interaction. The mantra here is innovate or perish. India moots HR strategy for Biopharma According to a note prepared by FICCI and the Department of Pharmaceuticals (DOP), the program-based teaching, is the way forward and has to replace the department-based teaching, in specialty areas. The primary reason given is that innovation, now lies in combining subjects, and is not within the domain of any subject. Combinatorial subjects are the 'new subjects' and can be modified, changed, kept dynamic, as time goes by. Such additions to the Education and Research (E&R) HR strategy, according to paper, would augur well to catalyze the Biopharma Leadership Plan. Highlights 1. The paper suggests that the biology as a subject is generally seen as boring or with uncertain future. Since the modern biology is different from the traditional biology and has mass appeal, there is need to draw mathematicians, physicists and engineers to help in augmenting the speed and depth of biopharma research. 2. The paper emphasizes on industry linkage to help in translational research by using common knowledge, equipment and science. Apart from NIPER, several institutes of DBT, CSIR and some independent ones, are functioning under DST. These institutes are present all over India and if they contribute to the common goal, it would be easier to build upon their research and develop some innovative products. Also, the coordination between the industry and these institutes would lead to the tremendous progress. BioSpectrum Bureau ]]> <![CDATA[Emphasizes on active research programs]]> https://biospectrumindia.com/news/95/1044/emphasizes-on-active-research-programs.html https://biospectrumindia.com/news/95/1044/emphasizes-on-active-research-programs.html Thu, 05 Aug 2010 16:44:00 +0530 10 Banaras Hindu University School of Biotechnology Name of the Department: School of Biotechnology Courses: MSc and PhD in biotechnology Coordinator: Prof. Sukh Mahendra Singh Address: Faculty of Science, Banaras Hindu University, Varanasi-221005, Uttar Pradesh Tel: +91-542-2368331 Fax: +91-542-368693 Email: sukhmahendrasingh@yahoo.com Website: http://www.bhu.ac.in/ Banaras Hindu University has a very active research program. It produces four to five PhD holders and publishes 20-25 research papers every year Established in 1986, the School of Biotechnology at the Banaras Hindu University (BHU) is one of the first five MSc biotechnology programs in the country that was started with the DBT support. The course is based on semester system and evaluation is based on credit. The school is among the top 3 preferred MSc biotechnology programs in the country. School invites 15-20 eminent professors/scientists every year for interaction with students in the area of biotechnology/life sciences. Almost all the students qualify for NET/GATE and about 70-80 percent qualify for JRF. In total, the school has seven full-time faculties and 46 visiting faculties including six from the industry. The school has a very active research programs in molecular microbiology, functional genomics, molecular and cellular immunology, tumor immunology, enzymology and plant biotechnology. Every year, it produces four to five PhD students and publishes 20-25 research papers. In view of its excellence in research, UGC and DST have identified the school under DRS (Phase II) and FIST (Phase I) support, respectively. The school has published over 50 papers in international journals between 2007 and 2009. Last year, the school has become a part of the newly formed DBT-funded interdisciplinary School of Life Sciences under which a sum of 24 crore has been sanctioned. The school is also associated with DST PURSE scheme. The work for PhD program has also been introduced from the current semester. The School of Biotechnology has received research grants from both private and public sectors. It received 39.8 lakh from the industry and 3.85 crore from government agencies between 2007 and 2010. The school has 18 labs dedicated to biotechnology. In terms of total capital expenditure, the cost on laboratory equipments came up to 63 lakh while the cost of consumables like reagents and biologicals came up to 55 lakh. Research projects worth several lakhs were sanctioned for the department every year. On an average, two research papers are published by school every year. Last year, nine students completed PhD. One of the remarkable achievements of the School of Biotechnology at the Banaras Hindu University was the 100 percent qualification of the students in national test for fellowships last year. One of the former student of the school, Antima Goel, has received L'Oreal UNESCO Women in Science fellowship this year. ]]> <![CDATA[Fast-tracking excellence with collaboration approach]]> https://biospectrumindia.com/news/95/1526/fast-tracking-excellence-with-collaboration-approach.html https://biospectrumindia.com/news/95/1526/fast-tracking-excellence-with-collaboration-approach.html Thu, 05 Aug 2010 16:43:00 +0530 9 Jamia Millia Islamia Department of Biotechnology Name of the Department: Department of Biotechnology Courses: MSc and PhD in molecular biology and biotechnology Coordinator: Dr Arif Ali Address: Maulana Mohammad Ali Jouhar Marg, New Delhi-110025 Tel: +91-11-26981717 Fax: +91-11-26980229 Email: aliarif@rediffmail.com Website: www.jmi.ac.in/Fnat/Biotechnology.htm In order to enhance growth, Jamia Millia Islamia approaches biotech industries for collaboration for product-oriented research and also for student placements The Department of Biotechnology at the Jamia Millia Islamia (JMI), a central university, was established in 2008. The department offers MSc and PhD courses in biotechnology and molecular biology. Prior to this, between 2001 and 2007, BSc and MSc courses in biotechnology were offered from the Department of Biosciences of the university. For MSc biotechnology course, the student intake capacity is 30. In 2009, seat to applicant ratio for MSc course was 1:50, making it the most popular course in the university. So far, six batches of MSc students graduated from the biotech department are well-placed in prestigious institutions such as IIT Bombay; IIT Delhi; MAMC (University of Delhi); AIIMS, New Delhi; NICD (Indian Council of Medical Research, Ministry of Health); and in reputed biotech companies. The department has five full-time faculties with four of them having PhDs, and 19 part-time faculties with 13 having PhDs. Between 2007 and 2010, the faculties of the department have published 19 research papers in Indian journals and 41 papers in international journals. The fully-equipped research labs of the department is funded by various government agencies such as UGC, CSIR, DBT, ICMR and DST; with around 25 PhD research fellows working on various advanced research topics. The department has tie-up with several research institutes in the US, the UK, Germany and Italy. The department has filed two patents with the Indian regulatory agencies in the last three years. The department has spent 6 lakh on purchasing books, 1 lakh on buying journals and 2.2 crore on setting up labs and 58 lakh on buying consumables and reagents in academic year 2009-10. Some of the important achievements of department include commencement of under-graduate research facility funded by the UGC with stipend and contingency to the students, Signing of MoU between ICGEB and JMI to carry out research on AIDS, and to organize lecture series with informative and thought-provoking lectures delivered by Indian and American scientists. Eventhough the department was created only in 2008, it has been making rapid progress in terms of generation of extramural research funding of more than 1 crore, establishment of teaching labs, installation of teaching infrastructure with multi-media aids and other co-curricular activities. The department has seven dedicated biotech labs for research and practical purposes. ]]> <![CDATA[Specializes in creating trained manpower]]> https://biospectrumindia.com/news/95/1476/specializes-in-creating-trained-manpower.html https://biospectrumindia.com/news/95/1476/specializes-in-creating-trained-manpower.html Thu, 05 Aug 2010 16:41:00 +0530 8 Tezpur University Department of Molecular Biology and Biotechnology Name of the Department: Department of Molecular Biology & Biotechnology Courses: MSc and PhD in biotechnology Coordinator: Dr Ashish K Mukherjee Address: Tezpur University, Napaam, Sonitpur-784 028, Assam Tel: +91-3712-267007 Fax: +91-3712-267005 Email: akm@tezu.ernet.in Website: www.tezu.ernet.in/dmbb Tezpur University focuses on emerging areas of basic and applied life sciences and creates trained manpower in the fields of molecular biology and biotechnology The Department of Molecular Biology and Biotechnology (MBBT) at the Tezpur University was established in 1997. The department is recognized by the Department of Biotechnology (DBT), Ministry of Science and Technology, Government of India, and granted accreditations for the post-graduate program. The department offers two-year MSc in molecular biology and biotechnology, five-year integrated MSc in bioscience and bioinformatics and PhD in molecular biology and biotechnology. There are 11 faculties in the department who are taking care of teaching as well as research activities. The Bioinformatics Infrastructure Facility (BIF) at the Department of Molecular Biology and Biotechnology was established in 2007 under the Biotechnology Information System Network (BTISnet) scheme of the Department of Biotechnology, Government of India to promote innovation in teaching biology through bioinformatics. The goal of this facility is to expose students and researchers to use bioinformatics in solving hard core biological problems. The bioinformatics facility at MBBT provides awareness about bioinformatics and its usefulness in the field of biological sciences, stimulates interest in students to undertake research in advanced methods in the field of modern biology, assists the teaching activities of biology and its allied areas of the host institute as well as the neighboring institutions, and provides laboratory support for students/researchers and computation facility to faculty and technical staff of the institute. In the academic year 2009-10, many students from this department have qualified in GATE, DBT-JRF, ICMR -JRF and UGC-CSIR NET exams. Most of the passed out MSc and PhD students from the The Department of Molecular Biology and Biotechnology are pursuing higher studies (doctoral and post-doctoral research) in some of the premier research institutes/universities in the country and abroad. In addition, many students have secured jobs in R&D sectors of industries as well as in scientific institutes as scientists, and as faculty members in many reputed universities and colleges all across the country. Since June 2007, the department has published 21 research papers in national journals and 31 research papers have been published in international journals. The department has filed four biotech-related international patents so far. Between 2007 and 2010, the department has developed two biotech-related products that were subsequently transferred to the industry. ]]> <![CDATA[Nurturing tech-enabled agricultural research]]> https://biospectrumindia.com/news/95/8356/nurturing-tech-enabled-agricultural-research.html https://biospectrumindia.com/news/95/8356/nurturing-tech-enabled-agricultural-research.html Thu, 05 Aug 2010 16:36:00 +0530 6 Tamil Nadu Agricultural University Animal Biotechnology Center Name of the Department: Center for Plant Molecular Biology Courses: BTech in biotechnology and bioinformatics, MSc in biotechnology and PhD in biotechnology Coordinator: Dr R Samiyappan (Director) Address: Agricultural College and Research Institute, TNAU, Coimbatore-641003, Tamil Nadu Tel: +91-422-6611462 Fax: +91-422-6611262 Email: directorcpmb@tnau.ac.in Website: www.tnau.ac.in/cpmb/biotech/.htm As a symbol of excellence in the field of plant molecular biology, TNAU's scientists have cloned a new cry gene, Cry2Ai, in 2009, for the first time in the world The Center for Plant Molecular Biology is located at the main campus of Tamil Nadu Agricultural University, Coimbatore. It all started when the Department of Biotechnology, Government of India, has extended the financial support to begin the manpower development program in biotechnology. Many programs of this center are carried out in collaboration with other disciplines such as plant breeding and genetics, crop physiology, plant pathology, agricultural entomology and microbiology. This center has three different departments such as the Department of Plant Molecular Biology and Biotechnology; the Department of Biochemistry; and the Department of Microbiology. The Department of Microbiology was started in 2003. The center has the state-of-the art laboratory facilities covering 15,000 sq.ft. and houses a modern tissue culture laboratory, a transformation laboratory, a molecular marker technology laboratory, central instrumentation facility, bioinformatics unit and a transgenic green house. A library with latest books on plant biotechnology is available in this center. The field facilities available at the Center for Plant Breeding and Genetics are used for field experiments. The staff at TNAU are actively involved in the development and release of drought tolerant rice varieties such as PMK3 and RMD1 (already released) and PMK4 (approved for release) through farmers' participatory mode of varietal selection. Similarly, the staff worked on the elite open pollinated brinjal varieties, CO2, MDU 1, KKM1 and PLR1 that were converted into Bt versions with a view to effectively control brinjal fruit and shoot borer. These Bt brinjal varieties, carrying Cry1Ac gene were developed in collaboration with Mahyco under ABSP II program. The center is also working on sheath blight resistant GM rice, which is now in field evaluation trials, based on the guidelines issued by the Government of India. The team of scientists cloned a new cry gene, Cry2Ai, in 2009, for the first time in the world. The department has 25 highly-qualified and experienced faculty members with 26 PhD holders, with overall 60 national publications and 61 international scientific publications. The Center of Plant Molecular Biology has filed one Indian patent and has developed two products between 2007 and 2010. The center has 35.05 lakh worth industry-sponsored projects and 5.21 crore worth government-funded projects. ]]> <![CDATA[Proven expertise in genomic research]]> https://biospectrumindia.com/news/95/1007/proven-expertise-in-genomic-research.html https://biospectrumindia.com/news/95/1007/proven-expertise-in-genomic-research.html Thu, 05 Aug 2010 16:32:00 +0530 5 National Dairy Research Institute Animal Biotechnology Center Name of the Department: Animal Biotechnology Center Courses: MSc and PhD courses in animal biotechnology Coordinator: Dr SL Goswami Address: NDRI, Karnal-132001, Haryana Tel: +91-184-252800 Fax: +91-184-2250042 Email: surender.goswami@gmail.com Website: www.ndri.res.in NDRI has produced more than 10 calves from a single cow in a year and the IVF technique was successfully used to produce the world's first IVF calf in buffalo National Dairy Research Institute was established in Bangalore; in 1955, it was shifted to Karnal in Haryana. Initiatives for conducting animal biotechnology research at NDRI were taken in mid-1980s under United Nations Development Program, 'Center of Excellence program on biotechnology'. Under this program, infrastructure facilities for research in biotechnology were developed at different divisions of the institute. The Animal Biotechnology Center at NDRI is involved in conducting research on high-end embryo biotechniques, including transgenesis, somatic cell cloning and embryonic stem cell production In 1987, NDRI introduced MSc in animal biotechnology. In the same year, on the basis of the recommendations of the National Task Force of the Department of Biotechnology (DBT), Government of India, a national project on Embryo Transfer Technology (ETT) was initiated at NDRI with the support of Indian Council of Agricultural Research (ICAR) and the United States Agency for International Development (USAID). This formed the basis for the establishment of a state-of-the-art Embryo Biotechnology Center at NDRI having specialized laboratories for conducting advanced research on various aspects of embryo biotechnologies. Very intensive research on embryo biotechnology at NDRI resulted in evolving and fine tuning of several embryo-related technologies aiming at multiplication of superior germplasm. Using the standardized protocol for superovulation and embryo transfer, NDRI has produced more than 10 calves from a single cow in one calendar year and the in vitro fertilization (IVF) technique was successfully used to produce the world's first IVF calf in buffalo. The IVF technique has also been used to produce the goat kids for the first time in India. Currently, the Animal Biotechnology Center is involved in conducting research on areas of high-end embryo biotechniques like transgenesis, somatic cell cloning and embryonic stem cell production. Recognizing its strength in genomics research, the center has been included in the 'Buffalo Gene Mapping' initiative of the Department of Biotechnology and Niche Area of Research on Buffalo Production and Reproduction Genomics by ICAR. Under animal genomics research, the center is working on characterization, mapping and QTL identification for useful economic traits in buffalo to understand its gene expression regulation of IVM and IVF event. ]]> <![CDATA[Knowledge-specific teaching system]]> https://biospectrumindia.com/news/95/1422/knowledge-specific-teaching-system.html https://biospectrumindia.com/news/95/1422/knowledge-specific-teaching-system.html Thu, 05 Aug 2010 15:35:00 +0530 4 Guru Govind Singh Indraprasta University School of Biotechnology Name of the Department: University School of Biotechnology Courses: BTech, MTech and PhD in biotechnology Coordinator: Prof Rajinder K Gupta Address: University School of Biotechnology, Kashmere Gate, New Delhi-110403 Tel: +91-11-28311539 Fax: +91-11-23865941 Email: rkg67ap@yahoo.com Website: www.ggsipu.nic.in USBT functions with a mission of generating world-class manpower and knowledge-base for biotech education, research and development Right from 1999-2004, the University School of Biotechnology (USBT) offered an integrated BTech/MTech course and PhD program. From the academic year 2004-05 onwards, the MTech program has been delinked from BTech program and the two programs are being offered under dual degree program. Admission is strictly through an All India Common Entrance Test. The vision of USBT has been to impart learner-oriented education, research, demonstration and dissemination of knowledge to the needs of a sustainable society. Considering the demands of training and research in the post genomic era, USBT plans to actively pursue projects and collaborative programs in plant/animal/microbial functional genomics, stem cell biology and industrial biotechnology. Advanced contemporary research is an important activity of the USBT that has led to the publishing of 200 research papers in last seven years. At present there are 25 students pursuing PhD under the guidance of faculty members. USBT's research areas covers various disciplines of biotech such as plant biotechnology, structural and functional genomics and proteomics, microbial and plant-based bioactives, biotic and abiotic stress signaling, development and metabolic regulation, animal biotechnology, immunology and molecular biology of human pathogens and disease, microbial biotechnology, food biotechnology, pharmaceutical biotechnology, and biosensors and bioinformatics. The students' profile at the department reflects its national character in terms of various regions, communities and gender. After completing BTech/MTech course, majority of students opt for PhD in leading research institutes in India and abroad. Some students successfully combine biotech course with MBA program. Faculty members of the USBT are PhD holders from top institutions in India and abroad and represent diverse areas such as genomics, bioinformatics, agricultural biotechnology, biomedical research, pharmaceutical biotechnology, environmental biotechnology and industrial biotechnology, as well as IPR, biosafety, bioethics and management issues. The faculties orient and update themselves frequently by attending refresher/orientation courses and participating in other prominent national and international conferences. Two faculty members have been conferred with the Best Teacher Award of the university for consecutive years. ]]> <![CDATA[UoH inculcates the research temperament]]> https://biospectrumindia.com/news/95/2343/uoh-inculcates-the-research-temperament.html https://biospectrumindia.com/news/95/2343/uoh-inculcates-the-research-temperament.html Thu, 05 Aug 2010 15:32:00 +0530 3 University of Hyderabad School of Life Sciences Name of the Department: School of Life Sciences Courses: MSc in biotech, animal biotech and plant biotech; MTech in medical biotech and bioinformatics; and PhD in biotech Coordinator: Prof. Anand K Kondapi (HOD) Address: Central University, Gachibowli, Hyderabad-500046, Andhra Pradesh Tel: +91-22-33611111 Fax: +91-40-23010145 Email: akksl@uohyd.ernet.in Website: www.uohyd.ernet.in The School of Life Sciences at UoH is active in conducting research programs and has filed five national and four international patents so far University of Hyderabad (UoH) is an institute that focuses on post-graduate teaching and research. The School of Life Sciences at UoH is ranked No.3 in this year's survey. The university was established as a central university by a Parliament Act in 1974. The university also offers courses under distance learning programs and is a member of the Association of Indian Universities (AIU), the Association of Commonwealth Universities (ACU) and International Council for Distance Education. Since 1988, an academic staff college has been functioning in the university campus under the University Grants Commission (UGC) scheme for improving the standards of teaching in colleges and universities. The college organizes orientation and refresher courses for colleges and university teachers. The School of Life Sciences offers post-graduate and PhD courses in biotech. MSc in biotech was started in 1990, the admission is through JNU common entrance and the intake capacity is 16; MSc in plant biotech was started in 2004 and has 20 seats, while MSc in animal biotech was started in 2000 and has 28 seats; MTech in medical biotech and bioinformatics courses were started in 2003 and 2006 with 14 and 22 seats respectively; and PhD in biotech was started in 2009 and has 18 seats. The university also offers an integrated MSc in system biology. After completing MSc in biotech, students undertake one year project work in one of the areas of the research in the school of life sciences. As part of the curriculum, students are also exposed to Intellectual Property Rights (IPR) and entrepreneurial skills. Researchers at the university have published several research papers in both national and international journals. Between June 2007 and May 2010, the institute has published 40 research papers in national and international journals. While from June 2003 to May 2007, the university has published 18 research papers in national journals and 128 papers in international journals. The department has 44 highly-qualified and experienced faculty members. The institute is active in conducting research programs and has filed five national and four international patents. The institute has received government funding to the tune of 15.73 crore and industry-sponsored projects of 12 lakh between 2007 and 2010. ]]> <![CDATA[JNU emphasizes on practical training]]> https://biospectrumindia.com/news/95/1385/jnu-emphasizes-on-practical-training.html https://biospectrumindia.com/news/95/1385/jnu-emphasizes-on-practical-training.html Thu, 05 Aug 2010 15:28:00 +0530 2 Jawaharlal Nehru University School of Biotechnology Name of the Department: School of Biotechnology Courses: MSc and PhD in biotechnology Coordinator: Prof. Rajiv Bhat (Dean) Address: New Mehrauli Road, New Delhi-110067 Tel: +91-11-26704089 Fax: +91-11â€“26741561 Email: rajivbhat@mail.jnu.ac.in Website: www.jnu.ac.in While embarking on providing quality education, the School of Biotechnology at JNU has focused on churning out the best brains in the area of biotechnology Jawaharlal Nehru University (JNU), New Delhi, was one of the first six universities in India to initiate a post-graduate teaching and research program in biotechnology in 1985, when a special Center for Biotechnology (CBT) under the joint sponsorship of the University Grants Commission (UGC) and the Department of Biotechnology (DBT), Ministry of Science and Technology, Government of India, was set up. The center was started to initiate biotech education program and was elevated to that of a School of Biotechnology (SBT) in 2006. The school offers MSc and PhD in biotechnology. Students are admitted to the MSc course on the basis of an all India entrance examination conducted by JNU on behalf of 30 universities of the country. In addition to the theory courses, the program gives more emphasis on practical training. MSc students undertake a two-semester research project work to orient themselves towards research in diverse areas of biotechnology. The PhD program enrolls 30 students. There are currently 11 faculty members in the School of Biotechnology. The MSc in biotech course offered by JNU gets the top 20-25 students every year from among nearly 20,000 students competing nationally. The course is supported by DBT and the total intake of students in 2010-11 is 31. The curriculum gives emphasise to molecular, physicochemical, and engineering aspects that are most relevant to biotechnology, making it unique among other biotech programs offered elsewhere in the country. In addition to the theory courses, the program places strong emphasis on practical training. The school has state-of-the-art instrumentation facilities including a central instrumentation facility, recombinant product development facility of GLP standard, spectroscopic facility, microcalorimetric facility, microscopic facility, protein production and purification facility and biosafety level 3 facility. The recombinant product development facility of GLP standards was set up (RPDF-GLP) under the FIST support from the Department of Science and Technology (DST) and it has the flexibility to be used for the production of both recombinant products as well as the purification and characterization of non-recombinant products. The biosafety level 3 laboratory is being constructed with the financial support provided by the DBT. The laboratory will be used for research involving manipulation of biological infectious agents, which may cause serious or potentially lethal disease, with special emphasis on bacillus anthracis. INTERVIEW â€œPrime focus should be on creating leaders and not workersâ€? -Prof Rajiv Bhat, dean, School of Biotechnology, Jawaharlal Nehru University Q What are the drawbacks of biotech education in India? There are lot of institutes offering BSc, MSc, BTech and MTech courses in biotechnology. But, because of the lack of qualified faculty members those courses are not up to the mark. Therefore, the quality has got hampered. In my opinion, quantity is important but quality of manpower is much more critical. Lot of institutes have mushroomed now and unfortunately most of them don't have the required infrastructure for quality education. Even in the DBT-endowed programs, state universities lack the adequate facilities. Also, the faculties in most of these institutes are on contract basis, they don't have permanent faculty for teaching subjects. State governments are slow in recruiting. Therefore, if possible, DBT can support them with their funding to ensure quality in education. Q What are the changes needed in curriculum and the way it is being taught? I believe it is impossible for a student to grasp the knowledge in plant biotechnology, animal biotechnology, mathematics and statistics at the same time and that too in a very short span of time. Therefore, there is need to create specialized courses. Students should have an option to choose from core as well as specialized subjects. The parents who put in money for imparting biotech education to their wards feel disappointed when their wards end up frustrated. India is a big nation and everyone need not be a biotech expert. There should be specific guidelines for the education scenario as far as biotech is concerned. As long as we don't have a proper faculty, we will not be able to maintain the uniformity in the courses. In most of the institutes, there are one or two permanent faculties to teach and that is not enough to impart the right education. Even at Jawaharlal Nehru University (JNU), we currently have 11 faculty members, who have been able to guide students in a very good way, but at the same time, we actually require 15 more faculty members. Q How has been the relationship of JNU with the biotech industry? School of Biotechnology at JNU holds the privilege of being the first university department of biotechnology to have transferred several technologies in the area of biotech, many of which are at advanced stages of commercialization with more in the pipeline. Also, many major companies approached the school for campus recruitment. However, rather than opting for jobs in industry most of the MSc holders from JNU decided to pursue higher studies (PhD in India or abroad). This is due to the fact that they are well aware of the fact that they will face stagnation in their career with only an MSc degree. Q How is the demand for manpower in biotech industry? The hype created about the manpower requirement for biotech industry is artificial. Of course, the manpower requirement is there, but not in that big way as being projected now. The industry has to reinvent itself and do some in house innovation. There is huge potential, still there are many unexplored areas that seek attention. The way academia can help the industry is by providing the quality manpower. And for that the need for specialized courses is necessary as teaching everything won't help. Otherwise, it will be like churning out students who are jack of all trades and master of none. We have to create thinkers and leaders not workers. We actually need entrepreneurs with intellectual capacity that drives innovation. â€œThe course structure is well-designed and the curriculum is well-integrated. The USP of the course is that we get complete picture of the research techniquesâ€? -- Manish, PhD student in biotechnology, JNU Rahul Koul in New Delhi ]]> <![CDATA[ICT rides high on institute-industry network]]> https://biospectrumindia.com/news/95/1331/ict-rides-high-on-institute-industry-network.html https://biospectrumindia.com/news/95/1331/ict-rides-high-on-institute-industry-network.html Thu, 05 Aug 2010 15:22:00 +0530 1 Institute of Chemical Technology Institute of Chemical Technology Name of the Department: Institute of Chemical Technology Courses: MSc, MTech and PhD courses Coordinator: Dr Arvind Lali (Coordinator) Address: Nathalal Parikh Marg, Matunga city, Mumbai-400019, Maharashtra Tel: +91-22-33611111 Fax: +91-22-33611020 Email: am.lali@ictmumbai.edu.in Website: www.udct.org, www.ceb.org.in In the last five decades, ICT has emerged as a major center for development of applied chemical sciences Founded in 1934 and now a deemed university, Institute of Chemical Technology (ICT) has been ranked No.1 in this year's survey. Last year, ICT was ranked No.3. Based in Mumbai, the institute offers training and research opportunities in the fields of chemical engineering, chemical technology and pharmacy. In the last five decades, ICT has emerged as a major center for development of applied chemical sciences with major capacity built in areas such as separation technologies, facilitated reaction technologies, multi-phase reactor design, pharmacy and pharmaceutical technologies, drug design (synthetic and natural), nutrition and food technology, oil processing and oleochemicals technology, polymers, surface coating and processing, fiber technology and dye stuff technology. ICT offers MSc in biotechnology, MTech in bioprocess technology with special focus on downstream processing, and PhD in bioprocess technology, food biotechnology and biotechnology. The department has 34 faculty members having a teaching experience of more than five years while an additional seven members having an experience of up to five years. Between June 1, 2007, and May 31, 2010, there were 28 scientific research papers published in national journals, while 390 were published in international journals during the same period. Total value of new industry-sponsored projects commissioned in ICT between June 1, 2009, and May 31, 2010, was estimated at 54.73 lakh, while the total value of new government/ government agencies/ government department/ undertaking sponsored projects commissioned in the same period came up to 33.91 crore. In terms of capital expenditure, the total cost for laboratory equipments came up to 14 crore, while the cost of consumables clocked at 55 lakh. The DBT-ICT Center of Energy Biosciences was inaugurated in May 2009 and it is India's first national bioenergy research center. It was set up at an initial cost of 24.8 crore and is a multi-disciplinary center with emphasis on cutting-edge technology development and transfer to Indian industry. The department has an extensive network with institutions and industries in India and abroad. A proposal for dedicated Department of Biotechnology has been forwarded to UGC. Presently, it houses 24 laboratories with 10 students accommodated in each lab space. There are plans to upgrade the present syllabus offered by the department. ]]> <![CDATA[USP-Industry-oriented academic modules]]> https://biospectrumindia.com/news/95/1772/usp-industry-oriented-academic-modules.html https://biospectrumindia.com/news/95/1772/usp-industry-oriented-academic-modules.html Thu, 05 Aug 2010 15:21:00 +0530 10 Padmashree Group of Institutions, Bangalore Name of the Department: Padmashree Institute of Management and Sciences Courses: MSc, MPhil and PhD in biotechnology Coordinator: Dr Anuradha Address: #149, Komaghatta, Sulikere Post, Kengri, Bangalore-560060, Karnataka Tel: +91-80-28485204 Fax: +91-80-23215517 Website: www.padmashree.org Padmashree has put in constant effort to impart technical skill in latest biotech tools to students to help them get placed in the competitive job market Padmashree Institute of Management and Sciences is affiliated to Bangalore University and recognized by the University Grants Commission, New Delhi. The institute has fully-equipped plant biotechnology, animal biotechnology, microbiology, biochemistry and organic chemistry laboratories. The institute is having well-qualified and experienced faculty with research projects sponsored by national and international funding agencies as well as industries. The wide range of skills that they learn and acquire at Padmashree opens up a variety of career options for students. The curriculum is integrated with a novel industry-oriented training module in collaboration with industry and subject experts to impart special skills and provide hands on experience. The under-graduate and post-graduate courses at the institute is integrated with 'BiodHRona', a novel industry-oriented modules designed in collaboration with industry and subject experts to provide hands-on experience and acquire techno-functional skills for students. Students are also encouraged to publish papers and posters at national and international journals/seminars/conferences regularly. Several of past students have published papers and are placed in reputed companies and research laboratories. The biotech department has eight full-time faculty members and six part-time/visiting faculty members. The college has eight labs for biotechnological experimentation. The department has externally-funded research projects worth 25 lakh from the government in various areas of biotechnology and industry-sponsored projects worth 8.5 lakh. The institute filed two Indian patents between 2007 and 2010 and earned a royalty income of 3.5 lakh between 2009 and 2010. â€œPadmashree has been imparting value education along with preparing students to become good professionals. We believe in 'man making' and achieving excellence as our team strives hard to bring out the best among the students. The biotech department has been providing quality education to students and also equipping them to be competent in the field of research and industryâ€? - Dr Anuradha M, dean, Padmashree Institute of Management and Sciences ]]> <![CDATA[A blend of education and training for excellence]]> https://biospectrumindia.com/news/95/1609/a-blend-of-education-and-training-for-excellence.html https://biospectrumindia.com/news/95/1609/a-blend-of-education-and-training-for-excellence.html Thu, 05 Aug 2010 15:15:00 +0530 8 KS Rangasamy Collegeof Technology Department of Biotechnology Name of the Department: Department of Biotechnology Courses: BTech, MSc and PhD in biotechnology Coordinator: Dr Ponmurugan Address: KSR Kalavi Nagar, Tiruchengode, Namakkal-637215, Tamil Nadu Tel: +91-4288-274748 Fax: +91-4288-274860 Website: www.ksrct.ac.in In order to provide additional training in the field of biotechnology, the biotech students of the college are given training in research institutions and organizations The Department of Biotechnology at the KS Rangasamy College of Technology, an autonomous institution affiliated to Anna University, Chennai, has a good infrastructure with state-of-the-art laboratory facilities for students. Students of the biotech department are allowed to use the laboratory facilities at any time of the day. The department offers MSc, BTech and PhD courses in biotechnology. The school is maintaining a Cyanobacterial Glue Bank that is open for other educational and research institutions. The plant tissue culture facility and the modern cell line facilities available at the department are being used by the students for their project work. In order to acquire additional training in the field of biotechnology, students of the biotech department are placed in research institutions and organizations during summer. The department also provides assistance to students in preparing for the CSIR, UGC and other competitive examinations. Activities such as mushroom cultivation, biofertilizer production, preparing plant tissue culture, growing medical plants, and producing vermiculture are some of the extension programs of employment for students even after graduation. The department has 22 full-time faculty members and five part-time members. In total, there are 16 labs dedicated for biotech students. The department has adopted the syllabus framed by Anna University, Chennai. Meanwhile, the faculties of the department take initiatives to update the syllabus in-tune with the requirements of the industry. So far, the department has published 42 research papers in national and international journals between 2007 and 2010. In addition, it has filed three Indian patents in last three years and got patent approvals for two from the regulatory agencies. In the academic year 2009-10, the biotech department has spent 1.32 lakh on books, 2 lakh on journals, 13.62 lakh on lab equipments and 3.75 lakh on consumables and reagents. The department runs a number of R&D programs in an effort to expose students to practical training. As a result of the research activities, the department has developed five products that were transferred to the industry and has earned a royalty income of 1.74 lakh in the academic year 2009-10. The department has attracted externally-funded research projects worth 22.71 lakh from the government in various areas of biotechnology and industry-sponsored projects worth 5.27 lakh. ]]> <![CDATA[Dynamic environment facilitates learning]]> https://biospectrumindia.com/news/95/2807/dynamic-environment-facilitates-learning.html https://biospectrumindia.com/news/95/2807/dynamic-environment-facilitates-learning.html Thu, 05 Aug 2010 15:12:00 +0530 7 Vellore Institute of Technology School of Biosciences and Technology Name of the Department: School of Bio Sciences and Technology Courses: BTech, MTech, MSc and PhD courses Coordinator: Dr Lazer Mathew (Director) Address: VIT University, Vellore-632014, Tamil Nadu Tel: +91-416-2202574 Fax: +91-416-2243092 Website: www.vit.ac.in/sbst To augment learning resources and promote interdisciplinary research, VIT has consolidated different disciplines into nine Schools of Excellence The objective of Vellore Institute of Technology (VIT) is to create a dynamic environment that facilitates interaction and dialogue. Qualified faculty members assigned with various theory subjects prepare course plans using the standard format provided by the institute with emphasis on learning of the students. The instructional or lecture delivery of the faculty will be through a set of educational technology/tools opted by the faculty. The university follows a transparent mechanism for admission. It administers its own entrance examination, VIT Engineering Entrance Examination (VITEEE) at 189 centers in 71 cities across India for admission to BTech program. Year-after-year, VITEEE has been gaining popularity. Similarly, it administers VIT Masters Entrance Examination (VITMEE) for the MTech program. Courses offered by each school are designed to incorporate a blend of knowledge, skills and the right attitude. The curriculum of each program is revised periodically to enable students to be in tune with the needs of the industry. The School of Biosciences and Technology offers undergraduate, post-graduate and doctoral programs in biomedical engineering, medical genetics, applied microbiology, biotechnology and bioinformatics. The school has 110 full-time faculty members with 87 of them possessing a PhD degree. The school has published 140 research papers in national and international journals between 2007 and 2010. The programs of the school cover the latest developments and are designed on the basis of technological and industrial requirements. The school has collaborations with national and international institutes and multinational companies. It hosts visiting scientists and encourages joint R&D work between academia and industry. It has strong links with Defense Bioengineering and Electro Medical Laboratories, Bangalore; Central Scientific and Instrument Organization, Chandigarh; Institute of Nuclear Medicine and Allied Sciences, New Delhi; Christian Medical College (CMC), Vellore; and Piramal Life Sciences, Mumbai. The school has filed three Indian patents and two international between 2007 and 2010 and has been granted with one Indian patent to its credit. Several R&D projects of the school are funded by the DBT, DRDO, DST and core industries. ]]> <![CDATA[Quality education with supportive lab facilities]]> https://biospectrumindia.com/news/95/2613/quality-education-with-supportive-lab-facilities.html https://biospectrumindia.com/news/95/2613/quality-education-with-supportive-lab-facilities.html Thu, 05 Aug 2010 15:08:00 +0530 6 Shoolini University of Biotechnology & Management Sciences Name of the Department: School of Biotechnology and Applied Sciences Courses: MSc, MTech, MBA and MPhil in biotechnology Coordinator: Prof P K Khosla Address: Post Box No. 9, Near Head Post Office, Solan-173212, Himachal Pradesh Tel: +91-1792-308000 Fax: +91-1792-226364 Email: khoslapk_2001@rediffmail.com Website: www.shooliniuniversity.com Shoolini has been focusing on imparting quality education in the area of biotechnology and the university has 20 specialized research labs to support this The School of Biotechnology and Applied Sciences at the Shoolini University of Biotechnology & Management Sciences offers MTech, MBA, MSc (Hons) and MPhil courses in biotechnology. The students are admitted to the courses through Rolling Test conducted by the Shoolini University followed by a personal interview. Among the students enrolled for different BTech, MSc/ MTech, MPhil and PhD courses many of them are clearing JNU and NET-GATE entrance examination every year. Out of 40 applications received for MSc biotechnology course, 35 students were admitted in the academic year 2009-10. The faculty of the school has vast experience in formulating and handling biotechnology-related national and international projects, under the overall guidance of Prof PK Khosla, former vice-chancellor of HPAU, Palampur and ex-advisor, Biotechnology, Government of Himachal Pradesh. The school has 30 full-time faculty members with 27 PhD holders. In addition to this, the school has 15 visiting faculty members and all of them are have PhDs and three of them are from the industry background. So far, the faculty members of the school have published 35 papers in Indian journals and 15 papers in international journals between 2007 and 2010. In total, the university has 20 research labs that are used for different areas of research. The staff of the school have developed three products and received grants worth 6 lakh from industry and 84 lakh worth projects from different government agencies between 2007 and 2010. The school has been focusing on imparting quality education in the area of biotechnology. In the last three years, one international patent has been published from the school. The school has spent 15 lakh and 4.4 lakh on purchasing biotech-related books and journals, 1.2 crore on lab equipments and 40 lakh on consumables and reagents in the academic year 2009-10. Out of 156 biotech students who cleared the exams in 2010, 90 students opted for higher studies. The school has been providing the industry exposure to the students from time to time. About 12 companies have conducted campus interviews in the academic year 2009-10. Every year, several students are getting campus placements offered by the companies. ]]> <![CDATA[Targets research in emerging technology]]> https://biospectrumindia.com/news/95/1592/targets-research-in-emerging-technology.html https://biospectrumindia.com/news/95/1592/targets-research-in-emerging-technology.html Thu, 05 Aug 2010 15:06:00 +0530 5 Vidya Pratishthan's School of Biotechnology Name of the Department: Vidya Pratishthan's School of Biotechnology Courses: BTech, MSc, MVSC and PhD in molecular biology and biotechnology Coordinator: Dr Sushama Ravindra Chaphalkar Address: Vidyanagari, MIDC, Baramati, Pune-413133, Maharashtra Tel: +91-2112-239385 Fax: +91-2112-239387 Email: director.vsbt@gmail.com Website: www.vidyapratishthan.org Vidya Pratishthan has 11 laboratories dedicated to biotech students and it carries out research projects in emerging areas of biotechnology Affiliated to the University of Pune, Vidya Pratishthan's School of Biotechnology, is ranked No.1 in industry interaction and No.6 in infrastructure score in the 6th BioSpectrum Biotech School Survey. The school offers BTech in biotechnology, and MSc (Ag), MVSc and PhD in molecular biology and biotechnology. The school has seven full-time faculty members with more than five years of work experience and six of them are PhD holders. There are 38 visiting faculty members, out of which 28 are PhD holders and 10 members are from the industry. Between June 1, 2007, and May 31, 2010, six research papers from the school were published in international journals. In total, there are 11 laboratories solely for biotechnology students with each laboratory having the capacity to accommodate 11 students. The labs are allotted for genomics, proteomics, animal biotechnology, plant biotechnology, bio-nanotechnology, microbiology, biochemistry, bioinstrumentation, fermentation, bioinformatics and environmental biotechnology. The school is involved in a couple of interesting research projects. For instance, the ongoing projects in bioinformatics lab are in-silico analysis of non-coding RNA gene responsible for Alzheimer's disease, and Quorum sensing: bacterial LuxI and LuxR quorum sensing regulators, 16S rDNA sequence data analysis and database designing. Projects under genomics include cDNA library construction from aegle marmelos and syzygium cumini (project funded by ICAR, New Delhi), and morphometry and phylogeography of honeybees and stingless bees in India (Funded by the DBT, New Delhi). Total value of industry-sponsored projects commissioned between June 1, 2007, and May 31, 2010, came up to 75,000 while the total value of government-sponsored projects commissioned between the same period came up to 14.50 crore. In terms of capital expenditure, the total cost of subscription to biotech-related books between June 1, 2009, to May 31, 2010, came up to 44,564. The amount spent on laboratory equipments in the same period came up to 1.65 lakh while the cost of consumables like reagents and biologicals came up to 5.97 lakh. In the academic year 2009-10, 24 MSc students completed their course, among them 11 students are pursuing higher studies and seven of them are qualified for JRF/ CSIR programs. The school also organizes campus placement interviews. ]]> <![CDATA[Gains recognition with research collaboration]]> https://biospectrumindia.com/news/95/2049/gains-recognition-with-research-collaboration.html https://biospectrumindia.com/news/95/2049/gains-recognition-with-research-collaboration.html Thu, 05 Aug 2010 15:04:00 +0530 4 Rashtreeya Vidyalaya College of Engineering Department of Biotechnology Name of the Department: Department of Biotechnology Courses: BE and PhD in biotechnology Coordinator: Dr Pushpa Agrawal (Principal) Address: RV Vidyaniketan, Mysore Road, Bangalore-560059, Karnataka Tel: +91-80-267178096 Fax: +91-80-28600337 Website: www.rvce.ac.in RV College of Engineering is ranked No.1 in infrastructure score in the 6th BioSpectrum BT School Survey. The college has 12 labs dedicated to biotechnology Rashtreeya Vidyalaya College of Engineering started BE biotechnology course in 2003 with the support of Rashtreeya Sikshana Samithi Trust (RSST). The department of biotechnology at RV College of Engineering was established in 2003. The department was accredited by the National Board of Accreditation (NBA) in 2008. The college is ranked No.1 in infrastructure score in the 6th BioSpectrum Biotech School Survey 2010. In placement score, the college is ranked No.5. In total, the college has 12 labs dedicated to biotech students. The biotech department has 20 well-qualified and experienced faculty members who have specialized in various disciplines of biotechnology and 10 of them are PhD holders. The faculty to student ratio of the biotech department is 1:13. The department is recognized as the research center from Visvesvaraya Technological University, Karnataka. The department has signed a memorandum of understanding with the University of Agricultural Sciences, GKVK, Bangalore, and the Karnataka State Women's University (KSWU) Bijapur. Various funded projects from government and industries are sanctioned to faculty members of the college to carry out research on various biotech-related topics. The courses offered by the biotech department are the combination of engineering sciences, core sciences, basic sciences, humanities and subjects related to immune technology, upstream downstream processing, plant tissue culture, biopharmaceuticals, agricultural biotechnology, microbial biotechnology, pharmaceutical biotechnology and forensic sciences along with fully-modified and well-equipped laboratories that are in line and compliant with current demand of the industry. The staff and students at Rashtreeya Vidyalaya College of Engineering have been undergoing training and taking up collaborative projects at the leading industries and institutions related to the fields such as Waters India, Biocon, NIMHANS, KIDWAI Cancer Institute, University of Agricultural Sciences, GKVK, IISc, and Indian Veterinary Research Institute. The major areas of research happening at the college are in renewable energy, hydrogen economy, membrane-based separation techniques, conversion of coal and wastes to liquid fuels, plant tissue culture, molecular biology, genetic engineering and nano-particles-based purification of proteins. So far, the department has published 20 scientific papers in national and international journals. ]]> <![CDATA[Experiential teaching to meet scientific challenges]]> https://biospectrumindia.com/news/95/2140/experiential-teaching-to-meet-scientific-challenges.html https://biospectrumindia.com/news/95/2140/experiential-teaching-to-meet-scientific-challenges.html Thu, 05 Aug 2010 14:58:00 +0530 2 SASTRA University School of Chemical and Biotechnology Name of the Department: School of Chemical and Biotechnology Courses: BTech, MTech and MSc in biotech, bioengineering, nanotech and bioinformatics Coordinator: Dr Swaminathan Sethuraman Address: Shanmugha Arts, Science, Technology & Research Academy, Tirumalaisamudram, Thanjavur-613401, Tamil Nadu Tel: +91-4342-264101 Fax: +91-4342-264120 Email: swami@sastra.edu Website: www.sastra.edu SASTRA University responds to scientific challenges by launching research initiatives in thrust areas such as pharma technology, medical nanotech, drug design The School of Chemical and Biotechnology at the SASTRA University is ranked as No.2 private biotech school in BioSpectrum BT School Survey 2010. In faculty score, SASTRA is ranked No.2 and in infrastructure score, it is ranked No.4. The school offers under-graduate programs in bioengineering, bioinformatics, biotechnology and chemical engineering; post-graduate programs in bioinformatics, chemical engineering and industrial biotechnology; and PhD programs. With a focus on traditional strengths in engineering and with emphasis on experiential learning, the institute offers innovative academic programs and continuously upgrades its curriculum. The School of Chemical Biotechnology's goal is to provide the best under-graduate and post-graduate education in the domain of life sciences, with programs designed to prepare the candidates to meet the challenges that its graduates will face throughout their professional career. The institute runs medical and nanotechnology programs as well. The school provides excellent infrastructure and student-friendly environment for learning and is equipped with stateâ€“ofâ€“theâ€“art laboratories, experienced faculty and a curriculum tailored to suit industrial needs. The department has a total of 86 full time faculty members with 33 of them possessing PhD degree and with over 5 years of teaching experience. The department has made 44 scientific publications in national journals and 121 in international journals between 2007 and 10. The department has more than 20 laboratories. The total investment in lab equipments and consumables was over 7 crore for the academic year 2009-10. The availability of excellent infrastructure coupled with an industry-oriented curriculum and expert faculty is reflected in the research output in the form of patents and publications and success rates of the students. The placement record of the students is greater than 90 percent. More than 63 students have already been placed in several life sciences companies and many students are pursuing research in premier research institutions across the world. The school has continuously been responding to scientific challenges by launching research initiatives in strategic thrust areas such as pharmaceutical technology, medical nanotechnology, drug design and Indian system of medicine. The department has externally-funded research projects worth 22.30 crore from the government in various areas of biotechnology and industry-sponsored projects amount to 44 lakh. ]]> <![CDATA[World-class infrastructure aids research pursuits]]> https://biospectrumindia.com/news/95/2158/world-class-infrastructure-aids-research-pursuits.html https://biospectrumindia.com/news/95/2158/world-class-infrastructure-aids-research-pursuits.html Thu, 05 Aug 2010 14:50:00 +0530 1 Jaypee University of Information Technology Department of Biotechnology and Bioinformatics Name of the Department: Department of Biotechnology & Bioinformatics Courses: BTech in biotechnology & bioinformatics, and integrated MTech in biotechnology Coordinator: Dr RS Chauhan Address: Waknaghat, Dumehar, Kandaghat, Solan-173215, Himachal Pradesh Tel: +91-1792-239231 Fax: +91-1792-245362 Email: rajinder.chauhan@juit.ac.in Website: http://www.juit.ac.in/bio/bio.php By strengthening its specialized centers for research and by improving its world-class infrastructure, Jaypee has become the No.1 private biotech school in India The Department of Biotechnology at Jaypee University of Information Technology (JUIT) offers four-year BTech programs in biotechnology and bioinformatics, a five-year MTech program in biotechnology, and a six-year dual degree BPharm-MPharm course. JUIT has been running post-graduate programs in biotechnology, bioinformatics and pharmacy-the three main pillars of bio-based industries-that provide a rare opportunity to faculties and students to learn with broad horizons and do projects in a holistic and conclusive manner. JUIT intends to strengthen research infrastructure in order to expose students to world-class research and also to provide them with hands-on training using latest technologies. The biotech department receives about 4,000 applications every year for the 90 seats it offers. The department is equipped with 12-15 labs providing practical training in various areas of biotechnology. The bioinformatics curriculum includes courses on algorithm design, machine learning, computational high throughput screening and drug designing, bioprograming and scripting languages. Last year, JUIT has achieved several milestones in education and research. The Department of Biotechnology & Bioinformatics has got the Institutional Program Support for establishing the Centers of Excellence and Innovation in Biotechnology and funding to the tune of 8 crore was allotted jointly by the Department of Biotechnology, Government of India, and the Jaypee University. The center would be the first-of-its-kind in India, setup exclusively with modern research facilities to pursue advanced research in genomics, proteomics, metabolomics and bioinformatics of high value medicinal plants. The overall goal of this center would be to elucidate the missing links in the biosynthetic pathways of major chemical constituents of medicinal herbs so as to develop gene markers for the identification, cataloguing and conservation of genetically superior strains of high-value herbs in the north-western Himalayas. So far, the faculties of the biotech department were awarded with R&D projects worth 4 crore from different funding agencies such as the DBT, DST, ICMR and DRDO. Three patents were filed last year. A new specialized center of research, 'Center of Genomics and Bimolecular Engineering,' at JUIT, will aim to strengthen modern areas of biotechnology such as metabolic engineering, synthetic biology and computational systems biology. â€œOur curriculum enriches knowledge and skills of studentsâ€? INTERVIEW - Dr RS Chauhan, head, Department of Biotechnology and Bioinformatics, JUIT Q How do you promote the academia-industry relationship at JUIT? The interaction between academia and industry is crucial, especially in the changing global employment scenarios. Industry has been raising concerns over the disproportion in the total engineering/science graduates passing out and their probability of getting recruited by companies. This problem can be tackled through interactions between industry and academia, so that intellectual and infrastructural resources of each can complement in bringing out best products and processes of practical value. Jaypee University of Information Technology (JUIT) has initiated several programs to interact with the industry, which include compulsory summer industrial training for students, regular scientific interactions with the industry personnel so as to prioritize our research programs, and to get support from the industry for our R&D activities. All these initiatives have been implemented to open up our students to real world problems. Q What are the strengths of biotech courses offered at JUIT? JUIT has implemented biotech curriculum with a strong engineering base, which includes courses in electronics and communication, computer science and IT, materials science, and biomathematics, in addition to core courses in biotechnology. The curriculum enriches the knowledge and skills of students so that they can excel not only in biotech but also in other emerging branches such as nanobiotech and biomedical engineering. A distinctive feature of our BTech curriculum is the project work in last two semesters wherein the students are asked to come up with a research problem aimed at addressing unanswered questions in any area of biological sciences or any other branch of science and technology. The biotech department has introduced an innovative system of elective modules to the final year students wherein the students are given a choice of choosing modules to strengthen their knowledge and skill profile in a particular technology. The elective module system complements the theoretical knowledge of students related to their project work. In addition to undergraduate programs, the JUIT runs PhD program in biotech, bioinformatics and pharmacy with a provision of teaching assistantship of `15,000 per month to scholars analogous to American Universities so that the students get an opportunity to conduct labs while pursuing their research. Q What are your views on the need for regulation of private biotech institutes? I would be very happy to have stringent regulations on quality of education not only in private biotech institutes, but also in government institutes as well. Barring a handful of universities/institutes in India, the biotech educational programs are run without adequate and appropriate infrastructure, thereby resulting in grossly under-qualified and under-trained manpower. Most of the educational institutes, both private and government, are producing graduates who are more of bench workers rather than thinkers or planners. Biotech or any other branch of science or engineering requires expertise at both these levels with sufficient academic competence and vision to identify a problem and design a strategy to solve it. We at the JUIT are training and producing BTech/MTech graduates who are more of thinkers and planners. â€œJUIT provides a pleasant environment that is conducive to the holistic growth of an individual. The college focuses on the overall development of an individual for a promising career growthâ€? -Sonali Singh, final year student of integrated MTech in biotech, JUIT Rahul Koul in New Delhi ]]> <![CDATA[11-20 Public institutes]]> https://biospectrumindia.com/news/95/2453/11-20-public-institutes.html https://biospectrumindia.com/news/95/2453/11-20-public-institutes.html Thu, 05 Aug 2010 14:46:00 +0530 11 MS Baroda University Department of Microbiology and Biotechnology Name of the Department: Department of Microbiology and Biotechnology Courses: BTech, MSc, Post MSc Diploma and Phd in biotechnology Coordinator: Prof BB Chattoo (Head) Address: Faculty of Science, Maharaja Sayajirao University of Baroda, Baroda-390002, Gujarat Tel: +91-265-2794396 Fax: +91-265-2792508 Website: www.bcmsu.ac.in/index.htm Maharaja Sayajirao University of Baroda's Department of Microbiology and Biotechnology was started in 1964, and since 1985, it offers MSc biotechnology course in addition to the master's course in microbiology. The post MSc diploma in genetic engineering and bioprocess development has been recently initiated, and is a specialized one year course with a total intake of 10 students. According to Prof Bharat Bhushan Chattoo, coordinator, Department of Microbiology and Biotechnology Center, there are many people from the industry applying for this course and half of the seats for this course are industry sponsored. Courses for the department, at regular intervals, are devised and introduced by a board of members, drawn both from the academia as well as from the industry. This keeps the department in tune with the trends and demands of the time. The program begins with a fundamental courses in biochemistry, genetics, microbiology and molecular biology and then proceed to a thorough study of their selected area of specialization. Students are also given basic training in developmental biology, genetic engineering, biochemical engineering and some aspects of biophysics, biostatistics and environmental biology. The biotechnology training program was started with support from NBTB (DBT) and UGC. In 2003, the department had produced 90 PhDs and a large number of research papers are regularly published in journals of international repute. 12 University of Jammu Department of Biotechnology Name of the Department: Department of Biotechnology Courses: MSc and PhD in biotechnology Coordinator: Dr Manoj K Dhar Address: Dr BR Ambedkar Road, Jammu-180006, Jammu & Kashmir Tel: +91-191-2456534 Fax: +91-191-2456534 Email: manojdhar@jammuuniversity.in Website: www.jammuuniversity.in The Department of Biotechnology at the University of Jammu was established in December 1998 with major funding from the DBT. Admission to the university that offers MSc and MTech in biotechnology is made through the national JNU entrance test. The first batch of students was admitted in August 1999. Out of the 80-odd post-graduate students produced by the department, most of them have opted for higher studies and few have joined the industry. The students have also been selected for PhD programs of reputed research institutes namely IISc, CCMB, NII and NBRC. The department has developed a well-knit course curriculum to help students to gain placements in research institutions of international repute. The department has also been selected for FIST grants by the Department of Science and Technology, Government of India. In total there are 12 labs in the department, out of which, five research labs are fitted with world-class laboratory tables with on-table facility for gas, vacuum and power. There is one plant tissue culture lab, two core instrumentation facilities, three labs for MSc students and a bioinformatics lab. The school of biotechnology houses fully-developed laboratories, radioactivity facility, in-situ hybridization facility, and cell culture facility. The department also subscribes eight international journals. The department has published 38 research papers in the national journals and 25 research papers have found place in the international journals.13 University of Pune Department of Biotechnology Name of Department: Department of Biotechnology Coordinator: Prof Jayanta Kumar Pal (Head) Courses: BTech, MSc and PhD courses in biotechnology Address: Department of Biotechnology, University of Pune, Pune-411007, Maharashtra Tel: +91-20-25694952 Fax: +91-20-25691821 Email: jkpal@unipune.ac.in Website:www.unipune.ac.in/academics/department/biotechnology The Department of Biotechnology at the University of Pune has many laurels to its credit and has been ranked No.13 in BioSpectrum BT School Survey 2010. Presently, there are three full-time faculty members who have a teaching experience of more than five years, with all three members being PhD holders. There are 30 visiting faculty members, out of which, 25 members have an experience of more than five years. Five members from the visiting faculty group have been drawn from the industry. Between June 2007 and May 2010, there were 14 research papers published in international journals while two in national journals. Total value of government-sponsored projects commissioned during this period amounted to 1.5 crore. The department has altogether five labs with each having the capacity to accommodate 25 students. In terms of infrastructure and upgradation, the department made significant investments over the past one year. The University of Pune and UGC have sanctioned 3 crore for a new building for biotechnology department. The department also received 10 lakh for infrastructure development from DST. It procured a number of modern sophisticated equipment (real-time PCR, HPLC, 2-D PAGE system) worth 1.3 crore from the University of Pune and the DBT. The total capital expenditure incurred on subscribing biotech-related books was 1.5 lakh, while for journals it was 1 lakh. The department has purchased about 80 lakh worth laboratory equipments and 25 lakh worth consumables, like reagents and biologicals, during 2009-10. 14 University of Burdwan Department of Biotechnology Name of the Department: Department of Biotechnology Courses: M.Sc and PhD in Biotechnology Coordinator: Dr Pranab Roy Address: Golapbag, Burdwan,West Bengal, 713104 Tel : +91-342-22657231 Fax : +91-342-2530452 Email: pranabroy@rediffmail.com Website: www.buruniv.ac.in The University of Burdwan, which was awarded four-star status by the National Assessment and Accreditation Council, is considered one of the best universities in West Bengal. The post-graduate Department of Biotechnology at the University of Burdwan was established in 2003 with the financial assistance from an NRI, Dr Asish Kumar Mandal who donated two endowment chairs in the memory of his late parents, one for professor in biotechnology and another for senior research fellow. Since 2006, the department is supported by the DBT. The department offers a two-year MSc biotechnology course for which the students are selected both by the department as well as by the All India Combined Biotechnology Entrance Examination, conducted by JNU, New Delhi. The department has a specialized laboratory for molecular biology, microbiology, tissue culture, protein chemistry, computer and bioinformatics, apart from two general labs for doing routine practical studies as well as research work. Other than round-the-clock internet facility, the department has a library with approximately 600 biotechnology-related books. So far, the department of biotechnology has published nine research papers in international journals and four research papers in national journals. The students graduating from the department have been placed all over India in national labs like NII, IITs IISER, IICB and also in various US universities.15 Shivaji University Department of Biotechnology Name of the Dept: Department of Biotechnology Courses: BTech, MSc and PhD courses in Biotechnology Coordinator: Dr Jyoti Prafull Jadhav (Head) Address: Department of biotechnology, Shivaji University, Vidyanagar, Kolhapur-416004, Maharashtra Tel: +91-231-2609365 Fax: +91-231-2691533 Website: www.unishivaji.ac.in Shivaji University was established in 1962. It has about 2,00,000 students studying in 225 affiliated colleges and recognized institutes. The university's department of biotechnology was established in 2003 and it offers BTech, MSc and PhD courses. Between June 2007 and March 2010, two research papers from the department have appreared in national journals, while 15 papers were publsihed in international journals. There are 20 visting faculty members with four members selected from the industry. The department focuses on researches in areas such as microbial biotransformation, plant biotechnology, environmental biotechnology, molecular biotechnology and bioinformatics. The department also has interdepartmental collaboration with department of biochemistry, microbiology, botany and zoology for teaching as well as research. Subject specializations offered to students include environmental biotechnology, plant biotechnology, and bioinformatics. 16 Cochin University of Science and Technology Department of Biotechnology Name of the Department: Department of Biotechnology Courses: BTech, MSc and PhD in biotechnology Head: Dr CS Paulose Address: Cochin University of Science and Technology, Cochin-682022, Kerala Tel: +91-484-2576267  Fax: +91-484-2576267 Website: www.cusat.ac.in The mandate of the Department of Biotechnology at Cochin University of Science and Technology is to train human resources in biotechnology to cater to the needs of the nation in harnessing the vast biodiversity and to promote bioindustries in the country. Research activities of the department are presently centered around areas such as microbial technology, medical biochemistry, genetic engineering, molecular neurobiology, cell biology and plant biotechnology. The research students of the university generally get absorbed as scientists in different national and international laboratories. On an average, about 60 percent of the MSc students from the university clear the NET and 80 percent pass the GATE. Thirty one students have so far taken their doctoral degrees from the department, which has also about 88 scientific publication in national and international journals to its credit between 2007 and 2010. The department has seven labs dedicated to biotech students. It has invested approx 9 lakh on books and lab equipments in 2009. 17 University School of Sciences, Gujarat University Department of Biotechnology Department: Department of Biotechnology Head: Dr Shailesh R Dave Address: Department of Biotechnology, University School of Sciences, Gujarat University, Navrangpura, Ahmedabad, Gujarat Tel: +91-79-26303225 Fax: +91-79-26303225 Website: www.gujaratuniversity.org.in/web/index.asp The Department of Biotechnology at Gujarat University is engaged in research work and has completed many projects funded by both government as well as industries. Between June 2007 and May 2010, the department has published six papers in national journals and eight in international journals. Total value of new industry-sponsored projects commissioned between June 2007 and May 2010 amounted to 45 lakh, while the total value of government-sponsored projects commissioned during the period was 21 lakh. The department houses two labs with each lab having a capacity to accommodate 25 students. The library is equipped with more than 750 books apart from the books available in the central library of the university. In terms of total capital expenditure, between June 2007 and May 2010, the total cost on subscribing biotech-related books was 1 lakh. During the same period, the cost incurred on laboratory equipments came up to 1 lakh while cost of consumables like reagents and biologicals amounted to 3 lakh.18 Kumaun University Department of Biotechnology Name of the Department : Department of Biotechnology Courses: MSc in Biotechnology Coordinator: Dr Veena Pande Address: Department of Biotechnology, Kumaun University, Bhimtal Campus, Bhimtal-263136, Uttrakahand Tel: +91-5942-248185 Fax: +91-5942-248042 Email: veena_biotech@rediffmail.com Website: www.kubic.nic.in The Department of Biotechnology at Kumaun University was established in 2000, with the support of the Department of Biotechnology, Government of India, and has since then developed as an important academic center in Uttarakhand. The activities of the department are focused on quality teaching program at MSc and PhD levels including the execution of major research projects in selected areas. Present intake for MSc is 21 and the admissions are based on the all India entrance examination conducted by JNU. The department has well-equipped labs for biochemistry, microbiology, molecular biology and plant physiology research. The department has also signed MoUs with most of the ICAR and CSIR institutes of the region for networking projects, use of each others lab facilities and registering their research fellows for PhD. Since 2003, 18 research papers from the department were published in national journals and 10 research papers have featured in international journals. 19 Guru Ghasidas Vishwavidyalaya Department of Biotechnology Name of the Department: School of Biotechnology Courses:  Integrated UG/PG in biotechnology, MSc and PhD in biotechnology Head: Dr Bhupendra N Tiwary Address: Guru Ghasidas Vishwavidyalaya, Koni, Bilaspur-495009, Chhattisgarh Tel: +91-7752-260405 Email: biotechggu@yahoo.com Website: www.ggu.ac.in The thrust areas of research at the School of Biotechnology are microbial bioremediation  of toxic heavy metals and organic pollutants in addition to the search for novel bioactive compounds from microbial resources. According to Dr BN Tiwary, professor and head of the biotech department, the institute is working in active collaboration with IARI, IMTECH (Chandigarh) and is in process of collaborating with corporate houses in designing the course structure as per the market demand for biotech products. Between June 2007 and May 2010,  three research papers were published in national journals, while two were publsihed in international journals. Total value of government-sponsored projects commissioned during this period was 2 lakh. Till date, 12 batches of students have successfully passed their MSc examinations. The School of Biotechnology regularly organizes short-term training courses, regional and national workshops and seminars. 20 Himachal Pradesh University Department of Biotechnology Name of the Department: Department of Biotechnology Courses : MSc and PhD in Biotechnology Coordinator: Prof Duni Chand Address: Himachal Pradesh University, Summer Hill, Shimla-171005, Himachal Pradesh Tel : +91-177-2830946 Fax : +91-177-2830775 Email: dunichand_2000@yahoo.com Website: www.hpuniv.nic.in/biotech.htm The Department of Biotechnology at Himachal Pradesh University was established in 1995 with major funding from state government and the Department of Biotechnology, Government of India. The department has all the major equipments needed for carrying out the experiments in biotechnology. These include the incubators, HPLC, fermenters, spectrophotometers, centrifuges, electrophoresis system and many other major equipments for the hands-on experience and the exposure to the students. Apart from regular courses, the department also offers short-term training for students from other institutions on payment basis. It has procured a total of 572 books based on different areas of biotechnology out of the DBT and UGC grants. With a faculty strength of six, the department is having collaboration with many national institutes such as Central Potato Research Institute, Shimla;  Indira Gandhi Medical College, Shimla; Institute of Himalayan Bioresource Technology, Palampur; IMTECH, Chandigarh; and Jawaharlal Nehru University, New Delhi. ]]> <![CDATA[Top 20 BioSuppliers]]> https://biospectrumindia.com/news/95/7307/top-20-biosuppliers.html https://biospectrumindia.com/news/95/7307/top-20-biosuppliers.html Thu, 08 Jul 2010 17:06:00 +0530 Top 20 BioSuppliers-2010 (Life Science Business) by Revenue Rank 2009 Company Revenues in FY 2009-10 1 Waters India 262.2 2 Agilent Technologies* 255 3 Spinco Biotech 250.68 4 Thermo Fisher Scientific* 210 5 Becton Dickenson* 180 6 Millipore India 177.02 7 Invitrogen Bioservices India* 150 8 Shimadzu Analytical (India) 141 9 GE Healthcare Life Sciences* 120 10 Imperial Life Sciences 112.85 11 Sigma Aldrich India* 100 12 Merck* 97 13 Sartorius Stedim India 95 14 RFCL 93.23 15 Genetix Biotech Asia 90 16 DSS Imagetech 88.08 17 Toshvin Analytical 85.1 19 Eppendorf India 73.63 20 Nishotech 70 Revenue in Rs. Crore                                                                                           *BioSpectrum estimates ]]> <![CDATA[Tackling India's swine flu]]> https://biospectrumindia.com/news/95/2417/tackling-indias-swine-flu.html https://biospectrumindia.com/news/95/2417/tackling-indias-swine-flu.html Wed, 07 Jul 2010 15:27:00 +0530 Exactly a year ago, the Influenza A H1N1 (swine flu) virus created widespread panic and havoc in many parts of India, affecting thousands of people. A year later, with the picking of the summer monsoon, the swine flu has reappeared in a big way. Over 1,000 people have tested positive for swine flu in the last few weeks. The death toll due to swine flu is also inching up. Even as this depressing news comes from various parts of the country like Kerala that were not severely affected in 2009, there is a silver lining. The country is much prepared to combat the disease. Two indigenously developed vaccines to combat the influenza have hit the market in June 2010, exactly a year after the vaccine manufacturers got into the act on their own to enhance the country’s preparation. Zydus Cadila was first off the block with its VaxiFlu-S, developed using a technology licensed from Novavax, on June 3. India’s No.2 biotech company, Serum Institute of India, Pune, has also released its novel, intra nasal swine flu vaccine, Nasovac in the last week of June. Serum has developed it on its own with the virus strain supplied by the World Health Organization (WHO) a year ago as part of its capacity building program for influenza vaccines. With both these vaccines priced at less than Rs 200 for  a standard 5 ml dose, the country’s dependence on imported swine flu vaccine will be reduced considerably. Indian companies will be in a position to supply a few million doses of the swine flu vaccine every month. More importantly, it provides the nation the ability to step up production if required in case there is a sudden spread of the flu. At the height of the swine flu scare last year, there were apprehensions that developing countries may be deprived of swine flu supplies if there was a major outbreak in the western nations. Luckily, the swine flu virus that spread all over the world in a matter of weeks, was actually a mild version.  What is more heartening is the fact that three more Indian companies are currently on the verge of bringing their swine flu vaccines into the market. When a good product comes into the market, biotechnology companies are in the limelight. These companies are assisted ably by large number technology providers without whose expertise and support, biotech product development cannot take  place smoothly. This edition of the magazine has the annual feature than ranks the BioSuppliers by revenue on the lines of the Top 20 biotech industry survey. As expected, the BioSuppliers segment growth is intricately linked to the biotech industry’s performance. So, there is surprise when the BioSuppliers industry registered only 7.5 percent  growth in 2009-10. The list too does not have too many surprises, with Waters retaining its No.1 position The BioSupplier survey is now more broad based. Almost all the major players in the industry have readily shared their sales data for the previous year with BioSpectrum. There have been some murmurs about the data captured in the previous years due to the complex nature of the industry’s business. It is very difficult to separate only the services/equipments uses solely by biotech researchers. Yet, the survey results are eagerly looked forward to and every company tries to learn the right lessons from their relative positioning in the rank tables. The revenue figures have been captured for 70 percent more companies. There is a glaring gap in the Top 20 tables this time. While the production process was on, a Bangalore-based company which was ranked No.18, withdrew from the survey, citing corporate policy, leaving us with very little time to update the remaining ranks. I look forward to your feedback on the survey and the usefulness of the rankings. It will give us the opportunity to ensure that there is no repetition of this at least in the next year’s survey. Group Editor <sureshn@cybermedia.co.in> ]]> <![CDATA[A moderate year for bioprocess segment]]> https://biospectrumindia.com/news/95/2731/a-moderate-year-for-bioprocess-segment.html https://biospectrumindia.com/news/95/2731/a-moderate-year-for-bioprocess-segment.html Wed, 07 Jul 2010 15:17:00 +0530 The trend towards single-use fluid handling bags, connectors and more critically the bioreactors was quite evident as the industry focused on reducing its capital costs and speed up its expansion and development time. Filtration Production technology in biopharmaceutical industry is currently witnessing a paradigm shift. The industry is increasingly switching from stainless steel equipment to single-use products. Even a highly cost-sensitive economy like India is witnessing increasing acceptance of single-use technologies. While the equipment business slowed down, in-line with the economic scenario in 2009, the consumables and single-use devices registered significant growth. The industry warmed up to the membrane-based chromatography devices which saw it progress from R&D through process development into commercial production with several customers in vaccine industry, as it allowed the users to quickly scale up the process. The trend towards single-use fluid handling bags, connectors and more critically the bioreactors was quite evident as the industry focused on reducing its capital costs and speed up its expansion and development time. The Indian biopharmaceutical industry is exploring the concept seriously—starting from disposable sterile connections on aseptic areas, extending to assemblies for process unit operations, mixing vessels at smaller scale and evaluating the pre-sterilized assemblies. The total market size for bioprocess equipment is estimated to be Rs 450 crore in 2009, in India, and has been growing at an average rate of 12 percent. Of this, consumables made-up for more than half. The bioprocess and filtration business in India is dominated by four large multinational companies. They are Millipore, which is servicing the biopharmaceutical and research industries, Pall Life Sciences, GE and last but not the least Germany’s Sartorius, which is gaining market share in the hardware business in the same segment. Since the beginning of 2010, Sartorius and Pall Life Sciences have bagged some large orders for core equipments for large biopharmaceutical plants. Clearly, these few large multinational principal companies dominate the filtration/ bioprocess marketplace with perhaps 10-15 per cent of the remaining sales going to 3M and Nishotech (distributor for Novacep) and other companies. Millipore leads the market with approximately 30 percent market share followed by Pall Life Sciences with 25 percent share. GE holds another 17 percent of the business, Sartorius has 15 percent and the north-based MDI is at 10 percent. Rest goes to other players. All these companies have continued their expansion in India by increasing the number of sales representatives, establishing dedicated CoE/ Validation/ Manufacturing/ Application development facilities to penetrate the market further. While Pall Life Sciences is relying on biotechnology, specifically—the vaccine segment, to fuel growth of its life sciences division in the coming years the company differentiates itself from competitors by working closely with clients to develop custom-filtration products. Millipore still maintains a large catalog of water filtration devices as well as filtration devices for drug manufacturing that competes directly with Pall Life Sciences. However, Millipore’s filtration and purification devices are used solely for research and drug manufacturing purposes. The company was first to set up India’s first Validation and PDS lab in Bangalore in 2004. Following which Pall Life Sciences too boosted its infrastructure and services in the region by creating a CoE in 2007. Sartorius, too, is not lagging behind. The company invested nearly Rs 28.52 crore (€5 mn) in India in expanding the competencies, capability and capacity to serve the group and Asian market requirements. The company is one of the largest manufacturers of fermentors. ]]> <![CDATA[Mass Spectrometry business shrinks to Rs 184 crore]]> https://biospectrumindia.com/news/95/2942/mass-spectrometry-business-shrinks-to-rs-184-crore.html https://biospectrumindia.com/news/95/2942/mass-spectrometry-business-shrinks-to-rs-184-crore.html Wed, 07 Jul 2010 15:15:00 +0530 However, the projections are encouraging. In 2010-11, the MS market is forecast to grow over 8 percent. In the previous years, this has been growing at a rate of 20-25 percent. Mass Spectrometry The MS technology remained unseen and not very well-accepted in India until the 1990s. The first buyer of the technology was Ranbaxy. They saw value and placed order for a second system, which was followed by few more buyers. When the CRO business started picking up in India, adoption of this technology started seeing a steady growth of 25-30 percent from 2000 onwards. In 2004, the market saw a growth spurt of 100 percent in the mass spectrometry segment. The MS market grew at a steady rate of 20-25 percent till 2007 touching Rs 200 crore between July 2006 and June 2007 with Lab India enjoying a formidable share. Lab India’s MS business (from ABI Sciex MS systems) stood at Rs 145 crore ($29 million) during that period. The global melt down in 2009, however, engulfed a few success stories of MS market that has been assiduously built up in the recent times. Since the investment value for MS is very high, this particular business saw adverse impact of greater magnitude. Suddenly, the market shrunk back to about Rs 184 crore ($40 Million) in 2009. The triple quad remained the largest segment in MS instrumentation accounting for a little more than half the revenue. The dominant player in this segment is ABI Sciex, with almost 50 per cent market share followed by Waters (20 percent). Thermo Fisher holds another 15 percent followed by Bruker (5 percent). Though ABI Sciex (distributed through Lab India) continues to enjoy the market leadership but their total share reduced significantly in 2009 compared to previous years. According to industry sources, ABI Sciex has got orders for 40+ units, followed by Waters, 20+ units and both Thermo Fisher and Agilent had orders for nearly 10 units, while a few orders were bagged by Bruker. Bruker which is a relatively late entrant in this segment is a worldwide leader in MALDI and TOF and MALDI-TOF mass spectrometry, not just in proteomics but also in genomics. Bruker Daltonics which holds approximately 5 percent market share, in 2009, announced the establishment of the Bruker LabMate Private Limited company, a life-science mass spectrometry joint venture between Bruker Daltonics and LabMate Asia, with customer support and technical expertise hubs in Bangalore, Chennai, Delhi, Kolkata and Mumbai. The Indian distributer LabMate made a seamless transition from a plain distributer to a majority-owned Bruker company. Even though the prospects for MS seem to be bright, paradoxically, the Indian market has a long way to go before it can catch up with the developed countries in terms of revenue. However, market is doing exceedingly well in terms of unit sales.  The trend for FY 2010-11 is very encouraging since both pharma and CRO segments are entering high growth trajectory, the triple quad is expected to hit 140 units in this fiscal year. Estimated revenue for MS systems during 2009 was about Rs 184 crore ($40 Million) ABI Sciex holds almost 50 percent market share followed by Waters (20 percent) ABI Sciex is estimated to have got orders for 40+ units, followed by Waters with 20+ units. Though ABI Sciex continues to enjoy the market leadership, its total share reduced significantly in 2009 compared to previous years. Triple quad MS is expected to hit 140 units in 2010-11. ]]> <![CDATA[Instrumentation market posts modest growth]]> https://biospectrumindia.com/news/95/5324/instrumentation-market-posts-modest-growth.html https://biospectrumindia.com/news/95/5324/instrumentation-market-posts-modest-growth.html Wed, 07 Jul 2010 15:13:00 +0530 The lab instrumentation market accounted for a reasonable share of the analytical instrumentation market, primarily, due to strong support from government research programs. Laboratory Instrumentation The Life Sciences Laboratory Instrumentation market comprises primarily of segments such as Centrifugation, Flow Cytometry, PCR and Spectrophotometer, Electrophoresis equipments. While these segments grab a major share of the total market pie, other minuscule segments include gene and protein sequencing along with imaging. The total Lab Instrumentation market in 2009-2010 stood at Rs 920 crore. Major players in the Lab Instrumentation market include Thermo Fisher Scientific, ABI, Beckman Coulter, Bio-Rad, Eppendorf, (Abbott Molecular & Dako), Roche, ABI, Perkin Elmer, GE, and Agilent. The total market size for centrifuges in 2009-2010 stood between Rs 100-120 crore and roughly 5,000 units in terms of volume. This segment again can be broken down to various sub-segments that include High Speed Centrifuges, Ultra Centrifuges, Table Top Centrifuges and Industrial Centrifuges. Market size for Ultra Centrifuges stood between Rs 30-32 crore ($5-7 million) while market size for high speed centrifuges stood at Rs 9.2 crore ($2 million) in 2009-2010. And if we include uptakes in blood banks then the figure for high speed centrifuges would touch the same mark as Ultra Centrifuges of Rs 30-32 crore ($ 5-7 million). While Ultra and High Speed Centrifuges cater to a very niche market segment (mainly the vaccine manufacturers), the market for Table Top Centrifuges is huge in India and revenue sales stood at Rs 36.8 crore ($8-10 million). Both Ultra and High Speed Centrifuges is mainly used for research and vaccine manufacturing processes. Major players in India in the Ultra Centrifuge space include Beckman Coulter with an 80 percent market share followed by Beckman. Major players in the High Speed Centrifugation segment again include Beckman Coulter and Thermo Fisher Scientific with Beckman Coulter having a market share of 55 percent followed by Thermo Fisher Scientific. High speed rotators are mainly available at 1.5 litres, 6 litres, 9 litres and 12 litres in India. While Beckman Coulter markets centrifuges up to 9 litres, Thermo Fisher Scientific has brought out centrifuges of up to 12 litres which is mainly in use for industrial purposes. Thermo Fisher Scientific also looks at, blood centrifuges having a stupendous market share of 70-80 percent. Table Top Centrifuges can be further sub-divided into mini micro centrifuges and micro centrifuges. Major players in the segment include Eppendorf having 30 percent market share followed by Sigma Aldrich, Thermo Fisher Scientific and Hitachi (operating in India through various distribution channels). These segments apart, there have been up upcoming segments like industrial centrifuges and continuous flow centrifuges. Prominent companies in industrial centrifuges include Alfa Laval and this again is mainly aimed at the emerging vaccine segment. However, this again is a niche segment due to only a handful of prominent vaccine players operating in the country. Eighty percent of the centrifugation instruments are imported while only 20 percent are local products manufactured by Remi and Plastocraft. Flow Cytometry in India clocked a market size of Rs 115 crore ($25 million). This segment can further be sub-divided into research flow cytometry, diagnostics flow cytometry and imaging flow cytometry. Major players in this segment include Becton Dickinson and Beckman Coulter. Being a high-end technology, Flow Cytometry is still in its nascent phase in India with just a handful of expertise available to operate on this technology. While in research, Flow Cytometry is used for checking toxicity, proteomics and genomics, in diagnostics, the technology is used right from low-end HIV testing to high-end cancer research. The other popular segment, PCR market in 2009-2010 witnessed an approximate growth rate of 7-8 per cent, clocking total revenue sales of Rs 55 crore. During the year, around 900-950 PCR units were sold. Including Real Time PCR, the volume reaches 1,100 units. Major players in the real time PCR market include ABI (with a market share of >40 per cent), Eppendorf (market share of 25-30 per cent) followed by BioRad and Roche at 15-20 percent each. The classical PCR market represented by Eppendorf has 30 percent market share followed by Bio-Rad with 30 percent market share. ABI with 10-15 percent share witnessed a single digit growth of 6-7 percent in 2009. The real time PCR market has, however, grown faster with a growth rate of upto15 percent due to the H1N1 outbreak. Around 150 RT PCR instruments were sold in 2009. Seed testing labs are the top most clients for PCR instruments especially those testing on rice, maize and Bt brinjal. Most of these laboratories, located in the Hyderabad, Aurangabad and Jalna belt opt for high-throughput PCRs. However, demand for most PCRs from the plant sciences industry are seasonal in nature, as it primarily depends on the season of the plant/crop. While a normal laboratory would opt for one PCR, a normal seed testing laboratory would opt for four PCRs which can test 384 samples at one time. In addition to this, there are a number of institutions working on seed genome projects like rice and maize and companies selling PCRs are bullish that this could be a growth area in the coming years. In addition, the demand for PCRs from these institutions will not dry up for a long time. Moreover, the growth of the reagents industry at 20-25 per cent has also accelerated the growth of the PCR segment. Though there is much emphasis on drug discovery in India, the demand for PCRs is less compared to the plant sciences industry, primarily, because in drug discovery, a PCR is needed only for gene sequencing. In addition to this, PCRs used in molecular diagnostic labs has not yet picked up as there are few labs in the country who opt for offering molecular solutions. On the whole, major part of the business comes from government laboratories not just because they have the funds but also because PCRs have become an absolute necessity. Other minor segments like Gene sequencing has a market size of Rs 25-30 crore in India. Major players include Roche Applied Biosystems and Illumina. There are around 20 placements, on an average, every year. Globally, 70 percent of market is held by Illumina while in India it is 30 percent. Many companies are now focusing on single molecule sequencing technology which is an upcoming technology. Again major part of this business comes from government research labs. Liquid handling systems is yet another segment which contributed roughly around Rs 100 crore. It mainly comprises products such as automated liquid handlers, dispensers, pipettes, etc. This business was not impacted much during 2009. Eppendorf a dominant player in this segment sold over 20,000 pipettes last year. Other important companies are Gilson, Biohit, Thermo, Tecan, Beckman Coulter and Qiagen. The total lab instrumentation market in 2009 stood at Rs 920 crore. The total market size for centrifuges stood between Rs 100-120 crore and roughly 5,000 units in terms of volume. Flow Cytometry in India clocked a revenue of Rs 115 crore. PCR market witnessed a growth of 7-8 percent, clocking total revenue of Rs 55 crore. Around 900-950 PCR units were sold. Including Real Time PCR, the volume was 1,100 units. While classical PCR market witnessed a single digit growth of 6-7 percent, real time PCR market grew faster at 15 percent due to the H1N1 outbreak. Liquid handling systems contributed around Rs 100 crore. ]]> <![CDATA[Competition hots up]]> https://biospectrumindia.com/news/95/1647/competition-hots-up.html https://biospectrumindia.com/news/95/1647/competition-hots-up.html Wed, 07 Jul 2010 15:12:00 +0530 There are more than 15 companies offering LC-related instrumentation and services in India. The top three companies—Shimadzu, Waters and Agilent Technologies—account for more than three-fourths of the total separation market. Cost concerns and budgetary restraints that resonated throughout the life science industry in 2009 affected chromatography product sales. But the demand for chromatography products continue to be the highest in analytical instruments business in India with a projected growth rate of 20 percent in 2010. Chromatography Separation technologies, including Liquid Chromatography (LC), Gas Chromatography (GC), and other techniques besides Ion Chromatography (IC), represent one of the largest segments of the analytical instrument market. The segment accounts for roughly 27 percent of the total BioSupplier market size.  The unrelenting needs for more efficient and faster analysis have led to significant new developments in chromatography in recent years, notably ultra-high performance liquid chromatography (UPLC), monolithic columns and hydrophilic interaction chromatography (HILIC). Waters’ UPLC has rapidly grown out of its infancy and moved into the analytical labs. Quickly following Waters other vendors have also brought out Fast LCs with similar objective but compatible with standard HPLC equipment. Agilent offers RRLC - Rapid Resolution Liquid Chromatograph. Shimadzu introduced UFLC – Ultra Fast Liquid Chromatograph offering high throughput but without high pressure. Dionex achieves Fast LC with Acclaim Fast column with UltiMate 3000 Intelligent LC. Thermo Fisher launched Accela High Speed LC that has been designed to optimize performance of sub–two micron particle columns and up to 15000 psi. A competitive market Today, there are close to 15 companies offering LC-related instrumentation and services in India. The top three companies—Shimadzu, Waters and Agilent Technologies—account for more than three-fourths of the total separation market. Fast LC is indeed the growth engine today, contributing to the enhanced growth of analytical HPLC. This technique is gaining wide popularity with a growth rate of 15 per cent. According to BioSpectrum estimates, total market for LC and associated parts and accessories for the year 2009 was over Rs 260 crore. In the case of HPLC, sale of 3,000 systems are average in the recent years. However, because of the credit crunch last year, the market came down to around 2,500 units. Waters and Shimadzu did better than other players and both continue to enjoy more than 30 percent market share each followed by Agilent. These three companies together hold close to 80 per cent of the market. Dionex and others share the remaining 10 percent. Waters continues to be the most popular in UPLC segment. The liquid chromatography market is clearly led by a few major participants, opportunities for smaller companies to make an entry is very less. The increased market potential in this segment has, however, seen many global players setting up either a direct subsidiary or a joint venture with their erstwhile distributors. One of the companies – Flexit Laboratories, Pune (now acquired by Grace Discovery Sciences) is locally manufacturing HPLC columns. In view of the increased demand for chiral columns, Daicel Chemical Industries has recently set up a Technical Support Laboratory at Hyderabad. The next big sub-segment Gas Chromatography or GC is estimated to have reported annual sales of about 1,200 units in 2009. The imported systems from Agilent, Perkin Elmer, Shimadzu, Thermo Fisher, and Varian are popular among both pharma and non-pharma customers and all these brands put together enjoy more than 75 percent of the market for GCs. There is an appreciable demand for GCs manufactured locally led by Thermo Fisher (earlier Chemito) and to a little extent by other manufactures like Nucon and CIC. Overall, the demand for chromatography products continue to be the highest in analytical instruments business in India with a projected growth rate of 20 percent in 2010. The market outlook is very positive through 2010, as the market leaders have already confirmed receiving good value orders in the first quarter of 2010. Chromatography represents one of the largest segments of the analytical instrument market, accounting for roughly 27 per cent of the total BioSupplier market size. HPLC sales stood at 2,500 units in 2009. GC annual sales stood at about 1,200 units. Estimated total market for LC and associated parts and accessories for the year 2009 were about Rs 260 crore. Shimadzu, Waters and Agilent Technologies together hold 80 per cent of the market share. Dionex and others share the remaining 10 per cent. Waters continues to be the most popular ub UPLC segment. Industry anticipates HPLC sales of over 3,000 units in 2010. ]]> <![CDATA[A steady revenue stream]]> https://biospectrumindia.com/news/95/2328/a-steady-revenue-stream.html https://biospectrumindia.com/news/95/2328/a-steady-revenue-stream.html Wed, 07 Jul 2010 15:10:00 +0530 Laboratory Consumables The consumable products have higher margins compared to big-buck items such as instruments, and are a steady source of income for a company because these are not tied to fluctuations in the end-user’s capital expenditure budget. Laboratory Consumables range from staple items such as plastic and glass ware, filters, chemicals and gloves, to instrument-related consumables, such as plates, columns, tubes and reagents. Consumables for life science applications have come to constitute a distinct category of laboratory consumables and include items such as microplates, DNA kits, oligonucleotides and gels. According to the BioSpectrum estimates, this market is close to Rs 2,025 crore, including Rs 875 crore for general consumables, Rs 950 crore for reagents, and Rs 200 crore for media. The general consumable segment, estimated to be close to Rs 950 crore, has players like Merck, Rankem and Qualigens (taken over by Thermo Fisher), and SD Fine Chemicals in control of the 60-65 percent market share. In molecular biology reagents sub-segment within this market—estimated to be around Rs 220 crore—Sigma Aldrich has 80-85 percent of the business which includes the organic reagents as well. However, Invitrogen through its distributors has a formidable presence in molecular biology reagents market. For scientists who use commercial reagents, Invitrogen currently outpaces its market peers for selection as primary supplier, followed by Sigma-Aldrich. Within this sub-segment itself, Bangalore Genei, which was acquired by Merck in 2009, has been catering to the the economical teaching kits and reagents for the educational market including the colleges and universities. This business is estimated to be worth Rs 25 crore in India. The overall media market is estimated to be close to Rs 200 crore and is dominated by HiMedia Laboratories and Difco. The culture media market size is around Rs 50 crore and at the same time the microbiology market is close to Rs 150 crore. HiMedia Laboratories is a popular choice as it offers wide range of economical culture media options. The other players include the international brands from companies like Merck, Sigma, and Invitrogen. Besides, there are many domestic players in this space which play an important role in the culture media space. In the peptones and industrial media category, Kerry Biosciences, Difco, Himedia are the major suppliers. The plastic ware and glassware markets combined add up to Rs 120-130 crore and constitute an important part of the Lab Consumables segment. Borosil is the major player. Corning range of glassware also holds some market share. Of late, many chemical suppliers have also ventured into the glassware space, with companies like Qualigens and the S.D Fine Chemicals promoting their glassware. The unbranded Chinese glassware has also been a part of this market. In plastic ware segment, the distributor companies like Genaxy has been a major supplier for the Indian market. In the chromatography Lab Consumables market, the majority of end-user needs are met by distributors and specialized manufactures. However, a growing number of consumables sales are being made by instrument companies themselves. Instrument companies selling consumables is nothing new but the trend has accelerated recently. This market is estimated to be worth Rs 200 crore, within the consumables market. Low susceptibility to fluctuations and margins higher than even instruments, no one can discount the importance of consumables in the analytical and life science market. BioSpectrum estimates this market to be close to Rs 2,025 crore, including Rs 875 crore for general consumables, Rs 950 crore for reagents, and Rs 200 crore for media. ]]> <![CDATA[$85 billion Market Cap grows marginally]]> https://biospectrumindia.com/news/95/1084/85-billion-market-cap-grows-marginally.html https://biospectrumindia.com/news/95/1084/85-billion-market-cap-grows-marginally.html Wed, 07 Jul 2010 14:40:00 +0530 Asia's Top 20 Companies by Market Capitalization Company Market Cap CSL, Austalia $14806.20 mn China Pharmaceutical Group, China $6401.28 mn Dr Reddy's Laboratories, India $4481.86 mn Sun Pharma, India $4093.15 mn Mindray Medical International, China $3682.60 mn Cochlear, Austalia $3527.13 mn Cipla, India $3482.63 mn Ranbaxy Laboratories, India $2879.37 mn China Shineway Pharmaceutical, China $2573.12 mn WuXi PharmaTech, China $1662.92 mn Glenmark, India $1561.57 mn GlaxoSmithKline Pharma, India $1393.18 mn Jubilant Organosys, India $1177.00 mn Lupin, India $1156.04 mn Cadila Healthcare, India $913.94 mn Simcere Pharmaceutical Group $706.11 mn Biocon, India $697.10 mn CK Life Sciences, China $646.93 mn The United Laboratories International, China $639.24 mn Sterling Bio $595.49 mn *Korea Market Cap data has not been available for this year. BioSpectrum Asia Pacific Survey 2010 estimates the market capitalization (MCap) of the life sciences companies in the region to be $85.46 billion at the close of the calendar year 2009. This excludes the market capitalization of the companies from Taiwan, Singapore, Korea* and some companies from China as the actual historical data was not available so extrapolation was used to arrive at the overall figure. Compared to last year the overall figure has grown only marginally. Even though the fortunes of a number of companies have taken a sharp upturn the currency fluctuations with respect to the US dollar evens out the gains. R&D spend averages at 9.44% Pharma gets the major share of R&D spend With slight improvement in the economy and business, in 2009, there was a marginal increase in the R&D spend. Though the rise was not significant, it indicates that the companies in the region are keen on developing new NCEs, biosimilars and generics. China companies continue to lead the tally with over 19 percent spend on R&D. There was a slight fall in the spending from companies in India and Malaysia as against an increase from Australia, Taiwan and Singapore. Taiwan and China companies successfully raised money by listing on stock exchanges during 2009. In terms of segments, pharma gets the major share of the R&D spending followed by MedTech and BioPharma. Though Biotech is at the bottom of the pyramid in this respect, Biotech companies across the region spent over $320 million during the year on R&D. ----------- Average R&D spent region wise ----------- ]]> <![CDATA[VLife partners with CRL to offer docking technology on HPC system]]> https://biospectrumindia.com/news/95/2306/vlife-partners-with-crl-to-offer-docking-technology-on-hpc-system.html https://biospectrumindia.com/news/95/2306/vlife-partners-with-crl-to-offer-docking-technology-on-hpc-system.html Wed, 07 Jul 2010 14:36:00 +0530 VLife Sciences Technologies (VLife), a Pune-based computer-aided drug and molecular discovery technologies provider, and Computational Research Laboratories (CRL), a wholly-owned subsidiary of Tata Sons and developer of commercial supercomputing facility ‘eka’, based in Pune, have partnered to offer VLife’s GRIP docking technology on CRL’s high performance computing platform. This new offering is expected to reduce the time required to conduct protein – ligand docking studies. Structure-based drug design approach has traditionally been affected by limitations due to either slow or inaccurate docking activity. Researchers rarely could access a solution that was fast while being accurate. With the combination of VLife’s innovative GRIP technology and the computational power of CRL’s supercomputer ‘eka’, researchers can improve productivity from their structure-based design efforts. With this joint offering, VLife and CRL have reinforced their commitment to address the scientific and technological challenges in the computational discovery domain on the basis of their core strengths. Supreet Deshpande, director, VLife Sciences Technologies, said, “Our alliance with CRL to provide accurate yet rapid docking service powered by our GRIP docking technology demonstrates VLife’s commitment to innovators in the area of life sciences in general and pharmaceuticals in particular.” “We are delighted to tie up with VLife to bring to scientists the combined power of a high performance computational cluster and a smart and accurate docking technology,” said Dr Vipin Chaudhary, CEO, CRL. RMS Regrow accredited with ISO 13485:2003 certification RMS Regrow, the cell therapy and cord blood banking service provider in India, has been accredited with ISO 13485:2003 certification. The company has received this certification for its therapies, Chondron and Ossron; and cord blood banking service, BabyCell. ISO 13485:2003 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that consistently meet customer requirements and regulatory requirements applicable to medical devices and related services. The primary objective of ISO 13485:2003 is to facilitate harmonized medical device regulatory requirements for quality management systems. Talking about the ISO certification Dr Vinayak V Kedage, lab director, RMS Regrow, said, “We are delighted to receive this certification. RMS has been following stringent quality management procedures in its business operations. The ISO 13485:2003 will ensure that our medical devices and related services will now be in compliance with global standards. This certification will further build trust and confidence of RMS amongst its customers and associates.” SIRO Clinpharm to set up operations in Asia Pacific region After establishing its presence in the US, Western and Eastern Europe, Indian CRO, SIRO Clinpharm is planning to expand its full-scale operations in the Asian Pacific region. “As far as clinical research is concerned, Asia Pacific is a huge market. Presently, we do not have any full-scale operations to conduct phase I-IV clinical trials. So, we are actively looking at setting up a base there,” said a company source to BioSpectrum. Details of the investments both in terms of infrastructure, manpower and finances are yet to be disclosed. Dr Chetan Tamhankar, CEO, SIRO Clinpharm, earlier told BioSpectrum that their strategy team has chalked out plans for North America and South East Asia in order to achieve a turnover of Rs 500 crore in the coming months. He also confirmed that the CRO’s  investors will opt for an exit strategy through an IPO route by 2011. SIRO presently has three investors that includes Kotak Private Equity, 3i and the promoter, the Daftarys. SIRO Clinpharm has already  made inroads into the APAC region through a number of strategic alliances. In April 2010, it announced its alliance with Virginia CRO (VCRO), a Taiwan-based CRO. VCRO has extensive network in the Asia Pacific regions including Japan, China, Singapore and Hong Kong. The pact with VCRO enables SIRO’s clients access to Taiwan’s clinical research market. The clinical trials market in Taiwan is an attractive destination for global pharma-biotech firms. In February 2010, SIRO also announced another partnership with a Korea-based CRO, DreamCIS. ]]> <![CDATA[Shimadzu launches Nexera UHPLC system]]> https://biospectrumindia.com/news/95/2435/shimadzu-launches-nexera-uhplc-system.html https://biospectrumindia.com/news/95/2435/shimadzu-launches-nexera-uhplc-system.html Wed, 07 Jul 2010 14:35:00 +0530 Shimadzu launched Nexera, an ultra high-performance liquid chromatography (UHPLC) system, which delivers high-speed and high-resolution analysis without sacrificing basic performance parameters such as excellent precision, near-zero carryover, good linearity, stability and ruggedness. Offering these attributes enables Nexera to provide superior performance in various fields. Nexera has high pressure endurance of up to 130 Mpa, fastest injection cycle of just 10 seconds, high temperature column oven at 150° C, lowest-volume mixer and most preferred front-end UHPLC for LCMS. Waters introduces new UPLC, HPLC columns Waters Corporation introduced new AcquityA ultra performance liquid chromatography (UPLC) and high-performance liquid chromatography  (HPLC) columns that offer method development scientists additional selectivity choices and improved chromatographic performance for separations using acidic, low ionic strength mobile phases. The three new chemistries will be available in fully-scalable UPLC, HPLC and preparative columns and particle sizes. The new CSH Technology-powered columns feature high-mass loading capacity for basic compounds and the ability to seamlessly scale separations between UPLC, analytical HPLC and preparative HPLC platforms. Millipore unveils rapid microbial detection system—Milliflex Millipore Corporation has launched Milliflex Quantum rapid microbial detection system. The system enables drug and vaccine manufacturers to respond to microorganism contamination earlier in the production process. The system is based on two widely adopted technologies 'membrane filtration, performed with proven Milliflex membrane filtration devices, and fluorescent staining' to ensure consistent and reliable results. The Milliflex Quantum system is ideal for testing raw material, in-process samples, final product and environmental samples. It is non-destructive, an important feature that enables operators to grow microorganisms in order to identify them with standard ID technology. TAKE Solutions ties up with Reliance TAKE Solutions has entered into strategic partnership with Reliance Life Sciences to supply its unique and innovative PharmaReady eCTD, SPL and PPM modules. The integration of TAKE Solutions’ products, support Reliance Life Sciences in strengthening product development services; but these customized IT solutions will also add a cutting-edge finesse to the present line of business. TAKE’s warehousing and clinical systems development and integration tools will deliver a full-spectrum of information management services, leveraging on industry data standards to streamline the clinical information lifecycle. ]]> <![CDATA[Ecron Acunova appoints Balaji Iyengar as CEO]]> https://biospectrumindia.com/news/95/7525/ecron-acunova-appoints-balaji-iyengar-as-ceo.html https://biospectrumindia.com/news/95/7525/ecron-acunova-appoints-balaji-iyengar-as-ceo.html Wed, 07 Jul 2010 14:34:00 +0530 Ecron Acunova, a full-service CRO, announced the appointment of Balaji Iyengar as country manager and chief executive officer for India. In this role, Iyengar will be responsible for managing and accelerating the growth of business in India and will be located at the company headquarters in Bangalore. Iyengar has been with the company since 2005 as a founding member. With over 15 years of corporate experience, he has been instrumental in evolving the strategy, monitoring performance and raising resources for the organization. Previously as CFO, leading the finance function at Ecron Acunova, he worked closely with key sponsors in finalizing several master service agreements and alliance agreements with business partners. Devashish Ohri joins Invitrogen as MD Devashish Ohri has been appointed as the managing director for South Asia with Invitrogen, part of Life Technologies. He has over 20 years of experience across different sectors. Ohri has graduated in history from St Stephen's College, New Delhi, and he did his MBA from INSEAD in France. Prior to joining Life Technologies, he was the sales leader for Eli Lilly India, focusing on diabetes care and institution business. ]]> <![CDATA[PM stresses on technology-aided agriculture to meet production targets]]> https://biospectrumindia.com/news/95/7278/pm-stresses-on-technology-aided-agriculture-to-meet-production-targets.html https://biospectrumindia.com/news/95/7278/pm-stresses-on-technology-aided-agriculture-to-meet-production-targets.html Wed, 07 Jul 2010 14:31:00 +0530 Prime Minister Dr Manmohan Singh while addressing the convocation ceremony at the Govind Ballabh Pant University of Agriculture and Technology, Uttarakhand, on June 19, 2010, said that policymakers and scientists need to put their heads together and work towards developing and implementing sustainable technologies that can produce more from less in the background of the new challenges of global warming and climate change. He said that without solid support from agricultural scientists and technologists it would have been impossible to achieve the  production targets. “There is a widespread feeling that there has not been any really big breakthrough in agricultural technologies since the green revolution of the late 1960s. This is a real challenge to the agricultural universities and our agricultural scientists in the country. India commands about 2.3 percent of the world’s land area and about four percent of the earth’s fresh water resources, but feeds about 17 percent of the world’s population. This puts tremendous pressure on our resources and makes the need for newer and better technologies even more critical,” said Dr Singh. While highlighting the government’s efforts in this direction during the last six years, the Prime Minister said, “The central government has endeavored to give the highest priority to agriculture. A number of centrally sponsored programs have been started to increase investment and to tap the unused potential for achieving higher productivity and production.” Singh also spoke about the agricultural extension as another area which needs urgent attention, particularly from the state governments. Avesthagen completes efficacy trials of Avent Avesthagen has successfully completed the pre-clinical efficacy trial for one of its biosimilar drugs, Avent, at Biomedcode Hellas. The results indicate that Avent developed by Avesthagen is effective in addressing arthritic conditions. Avent is the biosimilar version of a fully-humanized soluble tumor necrosis factor (TNF) receptor. Avent is indicated for reducing signs and symptoms, in patients with moderate to severe rheumatoid arthritis, ankylosing spondylitis, plaque psoriasis, psoriatic arthritis and juvenile idiopathic arthritis. Pre-clinical efficacy of Avent was carried out in a US FDA accredited human TNF transgenic murine model for rheumatoid arthritis. In these mice, the human TNF gene is over-expressed, which results in a progressive arthritic phenotype that is similar to that observed in humans. The results show that Avesthagen’s biosimilar Avent was effective in preventing the arthritic pathology developing in the transgenic mice when compared to control mice. Marked improvement was also evident in the group of mice treated with Avent in comparison to control group of mice, in all scores measured, namely statistically significant arthritis inhibition of about 60 percent in histopathology and about 80 percent with in-life clinical measurements. Avesthagen has successfully developed a proprietary expression vector technology pAVGEN to generate high protein yielding mammalian cell lines. The Avent cell line have been developed using this proprietary technology. This product is currently being scaled up for clinical trials at Inno Biologics facility in Malaysia. GEAC to consider commercialization of medicinal plants India’s biotech regulator, Genetic Engineering Appraisal Committee in its meeting held on June 9, 2010, in Hyderabad, decided to consider the views from the Department of Ayush, Ministry of Health and Family Welfare, GoI, on commercialization of transgenic medicinal plants. This decision was taken on a request by the Department of Ayush to the Ministry of Forest and Environment (MoEF) to co-opt the CEO of the National Medicinal Plants Board; adviser (Ayurveda) Department of Ayush; and DG of the Central Council for Research in Unani Medicine to the GEAC or to hear their concerns on commercialization of transgenic medicinal plants. ICAR to promote agricultural R&D in hilly regions For the first time since the establishment of first Krishi Vigyan Kendra (KVK) at Pondicherry, India, in 1974, Dr S Ayyappan, secretary of the Department of Agricultural Research (DARE) and director general, Indian Council of Agricultural Research (ICAR), had interaction with the program coordinators of 38 KVKs at the recently concluded 21st Regional Committee Meeting of the Indian Council of Agricultural Research (ICAR), India. This three-day meeting held at the Sher-e-Kashmir University of Agricultural Sciences and Technology of Jammu (SKUAST-J), from June 10-12, 2010, discussed the ways to promote research in the states of Jammu and Kashmir, Himachal Pradesh and Uttrakhand. India, Denmark to strengthen biotech research collaboration The Department of Biotechnology (DBT), Government of India, and the Danish Ministry of Science, Technology and Innovation have decided to further develop and strengthen the Danish-Indian research collaboration within the biotechnological area. In this regard, the DBT and the Danish program commission have invited researchers from universities, research institutions and private companies in India and Denmark that are conducting research within the biotechnology area to apply for funding of joint Indo-Danish strategic research collaborations. The aim of this call is for the funded project to be able to deliver considerable and tangible results at the end of the project period. Hence, the criteria has been kept as joint proposals that must be based on existing collaborations in the form of co-publication, PhD exchange, project collaboration or other relevant research-related activities of significant strength and importance within the field of biotechnology. The project proposal has to be written jointly by an Indian and a Danish research group and specify unison and close collaboration. The DBT and the program commission will support a joint strategic research project for a period of three-to-five years covering direct project costs. The total fund allocation is approximately Rs 11.42 crore. The final decision on which proposal to support will be made public in December 2010. The funded research project is expected to start early 2011. India extends its partnership with Germany in health research To support the R&D projects in the fields of common interest, the Indian government represented by Indian Council for Medical Research (ICMR) and German government represented by the International Bureau of the German Federal Ministry of Education and Research (IB-BMBF at DLR), have invited proposals for Indo-German cooperation in health research. The projects proposed to commence from February 1, 2011 include oncology, neurosciences, regenerative medicine and infectious diseases on the top priority. The scientists/faculty members working in regular capacity in universities, private/public R&D laboratories/institutes are eligible to apply under this program. The last date of submission of the form is set as June 30, 2010. The purpose of the funding is to stimulate new collaborations like the preparation of joint projects under national funding programs. The program facilitates bilateral cooperation between the scientific communities in India and Germany through joint research projects, bilateral workshops/seminars, exchange visits of scientists, scientific delegations and composite (scientific and industrial) delegation. Both sides will explore the possibility of funding from the European Union research programs. The ICMR, Department of Health Research (DHR), Ministry of Health and Family Welfare, Government of India, and the IB-BMBF at DLR, are the nodal implementing agencies from the Indian and German sides respectively. OPPI releases code on conduct for clinical trials In order to ensure that safety and well-being of research participants are fully-protected, Organization of Pharmaceutical Producers of India (OPPI) has set forth the code on conduct for clinical trials as guidance for member companies. In this regard, OPPI has recently released a booklet titled ‘OPPI code on conduct of clinical trials’. The key issues that have been addressed are protecting research participants, conduct of clinical trials, ensuring objectivity in research, and disclosure of clinical trial and its results. The main purpose is to reinforce the commitment to the safety of research participants and to address issues that bear on this commitment in the context of clinical trials that enroll research participants and are designed, conducted or sponsored (partially or fully) by member companies. The report has emphasized on the fact that the OPPI members conduct clinical trials in a manner that recognizes the importance of protecting the rights, safety and well-being of research participants. The  interactions with research participants, as well as with clinical investigators and other persons/entities involved in clinical trials, recognize the fundamental principle and reinforce the precautions established to protect research participants. The report also mentions that the investigator initiated studies, registries and any other organized data collection system like market research or health economic studies are outside the scope of this code unless collected as part of clinical trial. Ansal to set up Rs 1,000 cr biotech park Ansal API, an Indian real estate company, is planning to set up an 80-acre biotech park in Lucknow with an investment of Rs 1,000 crore. The proposed biotech firm, expected to be launched by year-end, would house around 42 biotech firms and a central processing zone with state-of-the-art facilities including high-tech labs. According to sources, Ansal API is in talks with Biocon and few other overseas companies, to set up the central processing zone. The realty firm is also keen on an exclusive tie-up with a single company to set up this zone, which is proposed to function as a common resource pool for all other firms in the park. Biotech Consortium of India Limited (BCIL), a consultancy firm jointly promoted by the Department of Biotechnology, financial institutions like the ICICI, IDBI among others and corporate firms such as Ranbaxy Labs, Lupin Labs, has been commissioned to draw up a detailed business plan for the project. This venture would be located amidst the sprawling Sushant Golf City, a township project of Ansal API spread across around 3,500 acre in Lucknow, India. The total investment in the park is in the range of Rs 1,500-2,000 crore, of which Ansal’s investment is likely to be in the range of Rs 800-1,000 crore, inclusive of the land cost. While a large chunk of investment involves the land bank that the company already owns, the rest of it is expected to be invested by companies that become partners in the project. ‘Jammu & Kashmir is capable of becoming a biopharma hub’: Omar Abdullah Addressing a one-day workshop on ‘Bio-Pharma Hub: Advantage Jammu and Kashmir’ organized by the Associated Chambers of Commerce and Industry of India (ASSOCHAM), Chief Minister of Jammu and Kashmir (J&K), Omar Abdullah urged for involving local entrepreneurs in exploring possibilities and advantages of this sector for setting up small and medium industrial units. “You need to engage local entrepreneurs to make necessary dent in this field and begin the activities utilizing the raw material abundantly available across the state. Before going for bigger ventures the activity can be started on smaller and medium scale,” suggested Abdullah. Abdullah added that he is hopeful that ASSOCHAM would focus on encouraging and associating local players in its efforts and intention of utilizing Jammu and Kashmir’s advantage as biopharma hub. “We have a high-class talent pool present in the state. Upgradation and creation of skills required in the biopharma and similar sectors is needed.” Surjit Singh Slathia, the Minister for Industries and Commerce, Jammu & Kashmir, said, “In the recent years, a large number of big and small pharma companies have shown interest in the state and investment for the sector is in the pipeline. We are trying to rope in investment worth Rs 1,500 crore in pharma sector, which in turn would generate about 3,000 jobs.” Slathia also added that J&K is a rich depository of medicinal plants which could be utilized for biopharma products of various ranges. India to establish AcSIR to enhance innovation On June 18, 2010, the Government of India, approved a proposal of the Council of Scientific and Industrial Research (CSIR) for setting up of an Academy of Scientific and Innovative Research (AcSIR) in the country. It will function as an institution for imparting instruction and awarding degrees in frontier areas of science and technology. The bill to set up the academy will be introduced during monsoon session of parliament. The academy will primarily focus on research and imparting training in such areas that are not ordinarily provided by existing universities in India. The curricula, pedagogy and evaluation will be innovative and directed towards creating the highest quality personnel in cross-disciplinary areas. While utilizing existing resources and facilities of CSIR, the academy will operate on a self-sustaining mode. The recurring expenses will be Rs 19.10 crore in the 11th Plan and Rs 61.79 crore in the 12th Plan. The main purpose behind setting up the academy is the decline in the number of PhD holders. The academy will be headquartered in Noida, and will produce 1,000 PhDs in science and technology and 120 in engineering every year after the five years of its commencement. The academy will also have campuses in 37 CSIR laboratories that are re-linked with the National Knowledge Network. CSIR has a pool of 4,500 scientists from different areas of science and it is expected that it could deploy 2,500 of them for the works in the academy. ]]> <![CDATA[Future looks bright for Indian biotech]]> https://biospectrumindia.com/news/95/2721/future-looks-bright-for-indian-biotech.html https://biospectrumindia.com/news/95/2721/future-looks-bright-for-indian-biotech.html Wed, 07 Jul 2010 14:24:00 +0530 Participation from 20 countries, 700 delegates and 800 B2B meetings made the Bangalore India BIO 2010 a notable one 'Biotech for a better tomorrow' was the focal theme of the 10th edition of Bangalore India BIO 2010, the rechristened form of India's biggest biotech show Bangalore BIO. The three-day event (June 2-4, 2010) held in Bangalore comprised multi-track conferences, international trade show, biopartnering, CEO conclave, bio excellence award and a host of other events. The multi-track conferences consisted of 25 sessions with over 100 speakers participating in it. Participation from 20 countries, 700 delegates and 800 B2B meetings made the event a notable one. The event organized by the Department of Information Technology, Biotechnology and Science and  Technology, Government of Karnataka, Vision Group on Biotechnology and MM Activ Sci-Tech Communications was inaugurated  by BS Yeddyurappa, Chief Minister of Karnataka. The other dignitaries present during the inauguration included Rob Norris, Minister of Advanced Education, Employment and Labor, Government of Saskatchewan, Canada; SV Ranganath, Chief Secretary, Government of Karnataka; Richard Hyde, British Deputy High Commissioner to Karnataka; Prof.  Samir K Brahmachari, DG, CSIR and Secretary, DSIR, Government of India; Ashok Manoli, Principal Secretary for IT & BT and Science and Technology, Government of Karnataka; Dr Kiran Mazumdar Shaw, Chairperson, Karnataka’s Vision Group on Biotechnology and CMD of Biocon and Aravind Jannu, Director, Directorate of IT and BT, Government of Karnataka and Managing Director, of KBITS. Dr Kiran Mazumdar Shaw gave an account of the 10 years of transformative period, in which Bangalore BIO has evolved to become Bangalore India BIO. She said, “Bangalore has become a global hub for clinical data management and post marketing data management. Now, we have most diversified bioclusters in Karnataka. Of the 380 biotechnology companies of India, 198 are in Karnataka and 191 of them are in Bangalore. Having come a long way, now is the time to shift from western centric models. India and China can play a lead role in the world in the areas of food security and healthcare.” Rob Norris said, “Canada has 33 agreements with India which include agriculture and health sectors. Canada is looking forward to work jointly with India in genomics, water purification and security, and food security.” “India has shown its competitiveness in the past two decades and now it is time to work towards R&D leadership. We can achieve this by removing hierarchical bureaucratic and academic structures. From next year onwards, India will produce about a million engineers and if we deploy them in the R&D projects even for few months, we can do wonders,” said Prof. Samir K Brahmachari. The 10th edition of Bangalore India BIO 2010 concluded on June 4, 2010 on a high note. The 11th Edition of the event will be held from May 4-6, 2011 in Bangalore. Industry needs stronger financial support: CEOs The panel was moderated by N Suresh, Group Editor of Bio Spectum and Technology Review India. The general consensuses was that companies primarily need financial support, a good state-of-the-art research platform and excellent networking skills. Session moderator summarized the session saying  “The government and the industry should work very closely to ensure that the industry grows”. Partnerships - key to drug discovery and R&D Optimistically opening a session on 'International partnerships - key to drug discovery and R&D', Dr Scott J Grossman, Vice President, Scientific Director, BBRC, Bristol-Myers Squibb Company, said, “A recent research has found that the API delivery time in 2010 just took one month. All this become possible due to the combined efforts achieved through partnerships. The factors that are required to be successful in partnership are bright, motivated, inquisitive, scientist working together on high end knowledge and discovery.” Mani Iyer, Group Director, Intas Biopharmaceuticals and Dr CSN Murthy, CEO of Aurigene Discovery Technologies were also part of the discussion panel. The speakers stressed that partnership is needed in all stages of drug discovery. Several partnership models are being used successfully in India. In the global biotech industry, Indian pharma companies are on the way to be recognized. The strategy should be flexible and there are no short cuts in this process of drug discovery. The discussion concluded on the note that partnerships are the best way to foster innovation and help discovery of new drugs. Biosimilars – big opportunity but bigger hurdles The session on “Successfully negotiating the biosimilars landscape” was scheduled on day two of the event. The session was chaired by Dr PM Murali, Managing Director, Evolva Biotech. Dr KV Subramaniam, President and CEO of Reliance Life Sciences, said, "The global biosimilars opportunity is significant, valued at about Rs 323,253 crore ($70 bn) covering 25 products. An integrated biosimilars initiative requires several competencies working seamlessly across the value chain. Competitive advantages in biosimilars will hinge on quality, cost, time-lines and regulated market access. The technology hurdles, significant cost and regularity pathway in development markets are major challenges faced. The right talent and partnership play a key role in addressing challenges in biosimilars.” Dr Eric Grund, Senior Director, Biopharma Applications, GE life sciences, said, “As the regulatory pathway for biosimilars in Europe and the US becomes clearer, manufacturing of these products still remain challenging. There is a pressure in increasing the efficiency and there are market uncertainties.” There is a geographic shift from west to east A session on 'Meeting the challenges and actualizing the potential in clinical trials' was chaired by DA Prasanna, Managing Director and Founder of Ecron Acunova. He said “India is engaged in clinical research for the last 15 years, reason being the size of the population, English communication, diseases burden, naive patient’s advantages, and western medical education. Dr Ferzaan Engineer, CEO of Quintiles India, said, “The landscape is changing and the new models of business are emerging. There is geographic shift from west to east and there is a need to adapt and  evolve. Change is the need of the hour. There is a need for potential reverse innovation in the pharmaceutical industry.” Regulatory issues for biopharma industry The event also had a session on “Regulatory issues for biopharma industry”. The speakers urged the Biotechnology Regulatory Authority of India to keep up with the rapid technological developments in the industry. Dr KK Tripathi, Adviser and Member secretary, RCGM of the Department of Biotechnology, Government of India, who presided the session, said, “As the regulators are not very clear on the latest issues of the industry, industry should take active initiative to bring their concerns to the regulatory authorities.” Dr Tripathi added, “Present regulations do not permit phase-I trials of any pharma product that is not developed in India. As the scenario is changing and in order to save the lives of many people we need to address such issues. Regulators are stressing for a change in this matter and the industry can expect good news soon.” Dr Smita Singhania, Head, Regulatory Affairs and Project Management, Cadila Healthcare; Dr Vibha Ahuja, General Manager, Biotech Consortium India; Teresa Stanek Rea, Partner, Crowell & Moring LLP, US;  Martin B Cox, Business Development Manager, Faculty of Medical sciences, New Castle University, UK; and Brijesh Patel, Deputy Manager, Licensing, Medicines and Healthcare Products Regulatory Agency, UK, were also part of the discussion. Issues in vaccine development A session on vaccines for emerging medical conditions, neglected diseases and pandemic preparedness was organized on day two. Dr SD Ravetkar, Senior Doctor, Serum Institute of India, began by saying, having been in this industry for the past 40 years, he has observed that vaccine industry was not growing much but he predicted that vaccine is definitely the future of India. Anjali Nayyar, Country Program Leader, PATH, said, “Pandemic has a social and economic cost and there is a need to have better preparedness for it. Over 300 infectious diseases have been identified so far, however, no vaccines are available for some of the diseases of public importance. Some vaccines exist but they are not optimally used.” Dr Vinayak, President, Biopharmaceutical Research Center, Panacea Biotec, said, “The challenges in this industry are business environment, scientific environment, traditional vaccine industry and competitive environment. In 2008, the vaccine market was estimated at Rs 96,977 crore ($21 bn). Companies invested about 15-20 percent in R&D in 2008. The cost to develop and license a new product is Rs 3,924-4,155 crore ($850-900 mn) in developed countries. Agribiotech day On the third day, a session was held on “New age technologies for food and nutrition security'. Dr KK Narayanan, MD, Metahelix Life Sciences, began the session by saying,“Most of the new age technologies are still in the lab and not on the field.” Further he added that the discussion would address serious problems faced in agriculture, whether we have the right ecosystem in India to support technologies, and if not, what changes can be made to make farmers access new age technologies. Discussions would also be on regulatory systems in India, its increasing uncertainty, issues regarding what Indian farmers believe and what they need. Prof. G Padmanabhan, NASI Platinum Jubilee Chair, Department of Biochemistry, Indian Institute of Science, Bangalore, said, “Traditional techniques of agriculture like crop rotation can tackle lots of issues, but India should not seclude itself from the experience and knowledge of the rest of the world. One of the arguments in the Bt brinjal case is that it has been developed by Mahyco in which Monsanto has 26 percent stake. China on the other hand has followed a dual policy; it has approved GM from MNCs and is also developing its own Bt rice.” He closed the discussion with the following recommendations – “Limited release of Bt brinjal seeds, decision on GM crops to be taken in Parliament based on scientific data, decisions to be taken on case-to-case basis.” GIM attracts global investments Karnataka wooed global investors with its ambitious Global Investors Meet (GIM) held on June 3-4, 2010, in Bangalore. The event aimed at showcasing the vast potential of investment in the state. Over thousand investors from all across the world took part in the two-day meet in Bangalore. GIM helped Karnataka government to ink healthcare projects worth Rs 4,500 crore. Chief Minister of Karnataka, BS Yeddyurappa announced that the State Government has signed 361 MoUs with investors for a total investment of Rs 400,000 crore. The Government plans to establish a system to monitor and review the progress of the projects for which MoUs have been signed. ]]> <![CDATA[48-50]]> https://biospectrumindia.com/news/95/3137/48-50.html https://biospectrumindia.com/news/95/3137/48-50.html Wed, 07 Jul 2010 14:23:00 +0530 48 Lablinks Biotech Head: Ravindranath Gandlur (CEO) Life Sciences Revenue: Rs 3 crore Business: Supplier of laboratory instruments Start-up Year: 1989 Address: C-16, KSSIDC Industrial Estate, Hoskote, Bangalore-562114, Karnataka Tel: +91-80-32440830 Fax: +91-80-27904790 Website: www.lablinks.in Capable equipment supplier Lablinks Biotech was started as a small scale industry in Hoskote, Bangalore in 1989. The company has been successful in developing import substitution for a number of critical equipments such as fermenters, tissue culture roller apparatus, blotting manifolds, and filtration equipments. Major customers of the company include prestigious institutions like Pasteur Institute of India, Indian Institute of Science, Sun Pharma, Intervet Laboratories, GB Pant University and Mediclone Biotech. In FY 2009-10, the company’s revenue is estimated at Rs 3 crore as against Rs 2 crore in FY 2008-09. Lablinks Biotech has launched an advanced version of the disposable bioreactors (patent pending). Produced in Class 10,000 clean rooms with imported medical grade PVC film, Lablinks disposable bioreactor systems are very versatile and can be used to manufacture high-end vaccines to low-end biofertilizers. With low initial and operating costs these systems have the potential to bring biotechnology to small and cottage industry too, as they are ideally suited to manufacture biofertilizers in the rural areas. 49 Bio-Age Life Sciences Head: Shashi Kumar Rana (CEO) Life Sciences Revenue: Rs 2.85 crore Business: Distributor of life sciences equipments. Start-up Year: 2004 Address: SCO-I, Indl Area, Phase-9, Mohali-160062, Punjab Tel: +91-172-6534210 Fax: +91-172- 5095350 Website: www.bioageindia.com Instruments-centric business Bio-Age is an ISO 9001:2000 certified company established with the objective to provide efficient, eco-friendly, and economical equipments, services and solutions to biotech industry. It has nationwide distributor network to provide prompt sales and after sales services. Bio-Age has its in-house training and R&D center to provide complete practical training on upstream and downstream process related to fermentation technology. The R&D center was established to impart practical exposure in the field of fermentation and water purification systems and allied aspects to the students in general, faculty and the company executives in particular. Bio-Age also provides a platform to the scientific community or industry to scale up their new products on hire basis, prior to its final launch without investing in their own lab setup. The company has been a pioneer in the field of indigenous and imported biotechnology equipments such as fermenters/bioreactors for laboratory to pilot scale applications, ultra-filtration (TFF), UV/VIS spectrophotometer, micro centrifuges, and imported laboratory equipments.  50 Pooja Lab Equipments Head: GG Pillai (CEO) Life Sciences Revenue: Rs 1.50 crore Business: Manufacturers of scientific instruments, ice flakers, incubators, seed germinators, plant growth chambers etc. Start-up Year: 1988 Address: No. 22, Bhandup Industrial Estate, Pannalal Compound, LBS Marg, Bhandup (West), Mumbai-400078, Maharashtra Tel: +91-22-25968723 Fax: +91-22-25968546 Website: www.poojalabequips.com Caters to customized needs Pooja Lab Equipments manufactures scientific instruments, incubators, seed germinators, plant growth chambers, and other lab equipments. In fiscal 2009-10, the company clocked biotech revenues of Rs 1.50 crore. In 1990, the company introduced its sophisticated fully-automated lab. In 1992, Pooja Labs  saw its business take an upward swing. Keeping in view of the growing global demand for a clean and green environment, Pooja Labs started manufacturing eco–friendly refrigeration equipment. The next challenging task came from the Space Application Center (ISRO) Government of India, Ahmedabad, to manufacture different instruments according to their requirements. Pooja’s equipments reach out various industries such as laboratories, educational institutions, pharmaceuticals, agro-techs, biotech, space research, and food and beverages. The company today manufactures glass door refrigerator, BOD incubator, plant growth chamber, stability chamber, environmental test chamber, seed chamber, upright model ultra low temp. deep freezer, incubator shakers, blood bank refrigerator, bacteriological incubator, lab oven, lab equipments and seed germinator. ]]> <![CDATA[42-44]]> https://biospectrumindia.com/news/95/1197/42-44.html https://biospectrumindia.com/news/95/1197/42-44.html Wed, 07 Jul 2010 14:17:00 +0530 42 Crane Process Flow Technologies Head: Vijay J Malik (CEO) Life Sciences Revenue: Rs 6.50 crore Business: Manufacturer of valves, chemical equipments, butterfly valves, pumps and pneumatic actuators Start-up Year: 2001 Address: Amar Avinash Corporate Plaza, 7th Floor, Plot No. D2, CTS No. 11/1 to 11/4, Bund Garden Road, Pune-411001, Maharashtra Tel: +91-20-30546100 Fax: +91-20-26050927 Website: www.craneflow.com Flourishes with flow technology Crane Process Flow Technologies  was established in April 2001 through the acquisition of well-known brands including Saunders, Depa and Revo. Crane Process Flow Technologies specializes in providing solutions to the diversified process industry, through the development, production and distribution of valves, actuation, pumps and related flow components.   The products offered by the company include diaphragm valves, butterfly valves, ball valves, check valves, diaphragm pumps, peristaltic pumps, quarter turn and linear actuation. Over the years, the company in India has gained vital knowledge and experience in many industries including biopharma. Apart from India, the company has offices in the UK, Dubai, Belfast, Italy, Austria, Belgium, the US and Germany. Some of its well-known  products and services include center line resilient seated butterfly valves, DEPA air operated diaphragm pumps, Duo-Chek II, ELRO peristaltic pumps, Flowseal high performance butterfly valves, Noz Check, REVO quarter turn actuators, Saunders HC4, and Single Chek I. 43 Tecpharma Systems Head: K Pullaiah (CEO) Life Sciences Revenue: Rs 6 crore Business: Supplier of scientific instruments Address: Tecpharma House, Plot No.115, Brindavan Estate, Nizampet Road, Kukatpally, Hyderabad-500072, Andhra Pradesh Tel: +91-40-23061666 Fax: +91-40-23062077 Website: www.tecpharma.in Keeps customers in comfort Tecpharma Systems is a supplier of the scientific instrumentation to the pharmaceutical industry, and also to drug discovery, life sciences and biotechnology applications. The company reported sales of Rs 6 crore from its life science products in fiscal 2009-10 as against Rs 4 crore the previous year. The company represents a wide set of manufacturers of instruments and its own innovative systems having a broad set of applications ranging from biomedical, analytical, biotechnology research, clinical research organizations, animal science research and drug discovery. Exclusive association with some of its principals helped Tecpharma to get acquainted with customers all over the country in a short span of time.   The company sells a largest selection of ultra low temperature freezers, refrigerators, incubators, centrifuges, complete range of water baths, stirrers, rockers, vortex mixers, animal lab equipment, animal behavior and physiology equipment and data acquisition systems.  Apart from providing quality products at fair prices, the company is working towards providing superior pre and post sales service to keep the customer in comfort. 44 Sisco Research Laboratories Head: SK Agarwal (CEO) Life Sciences Revenue: Rs 5.30 crore Business: Manufacturing and  processing of molecular biology reagents Start-up Year: 1975 Address: No.26, Navketan Indl. Premises, Shanti Nagar, Mahakali Caves Road, Andheri (E), Mumbai-400093, Maharashtra. Tel: +91-22-42685800 Fax: +91-22-42685801 Website: www.srlchem.com Operates in niche markets Sisco Research Laboratories (SRL) is an ISO 9001-2008 and CE approved manufacturing company specializing in manufacturing and processing of molecular biology reagents and chromatographic material for electrophoresis techniques. For fiscal 2009-10, SRL clocked annual revenues of Rs 5.30 crore as opposed to Rs 5.10 crore in fiscal 2008-09.  The company also manufactures agaroses and gel filtration media, which are premier products used in the biotech industry. SRL operates in specialized markets of enzyme substrates, proteins, enzymes and HPLC reagents. SRL also produce dehydrated culture media to meet the critical requirements of life sciences industry.  SRL manufactures and markets over 2,200 compounds in different grades and standard pack sizes. The company offers sophisticated and high purity chemicals in bulk and semi-bulk packs to the R&D and production units of various industries, universities and research institutions. It sells DNA markers, ladders and vectors to all the leading institutes and organizations in India and abroad. SRL is the only Indian agent for Senn Chemicals, Switzerland, and it is also the distributor for Amersham Biosciences, UK.  ]]> <![CDATA[39-41]]> https://biospectrumindia.com/news/95/1540/39-41.html https://biospectrumindia.com/news/95/1540/39-41.html Wed, 07 Jul 2010 14:16:00 +0530 39 Automed Systems Head: TK Bhanu Prakash (CEO) Life Sciences Revenue: Rs 10 crore Business: Automation of life sciences processes and instrumentation Start-up Year: 1998 Address: #1374, 1st Floor, 32 E Cross, Jayanagar 4th T Block, Bangalore-560041, Karnataka Tel: +91-80-41214435, 41210357 Fax: +91-80-41214435 Website: www.automedsystems.com Emphasis on lab automation Automed Systems offers complete solutions for automation of life sciences processes and instrumentation for drug discovery, microbiology, biotechnology, liquid handling, temperature control, sterilization and validation applications. The company has registered life sciences revenue of Rs 10 crore in fiscal 2009-10 as against Rs 9.80 crore in fiscal 2008-09. The company is focusing on offering knowledge-based solutions for the life sciences community and  specializes in automation in microbiology, instrumentation for biotechnology and medical devices with services and application support functions that meet the needs of the pharmaceuticals, healthcare, food and agro, academics and drug discovery areas. The company, currently, supplies products from Wheaton Science products, US; AES Laboratorie, France; Integra Biosciences AG, Switzerland; MRC, Israel; Orange Scientific, Salvis Labs and few more manufacturers. It has products to offer right from sampling to analysis and validation of your results. All the products of Automed Systems are GMP and CFR compliant. 40 Saksham Technologies Head: Sameer Maheshwari (CEO) Life Sciences Revenue: Rs 10 crore Business: Distributor of biotech and pharma equipments Start-up Year: 1992 Address: 102, Sita Nivas, Plot No. 94, Liberty Garden, Malad (W), Mumbai-400064, Maharashtra Tel: +91-22-40730202 Fax: +91-22-28893636 Website: www.saksham.co.in Thrives on service support Saksham Technologies was founded by a team of technocrats dedicated to provide  after-sales service support, support on service and application engineering, with in-house capabilities for critical jobs of refrigeration, clean room equipments, clean air systems, pressure vessels, vacuum engineering and electronics troubleshooting.  Saksham has a team of professionals with branches strategically located in Ahmedabad, Bangalore, Chennai, Chandigarh, Delhi, Hyderabad, Lucknow, Pune to cater to a large installation base. Some of the major products of the company such as centrifuges ultrasonic homogenisers incubators and crybaths deep freezers, biosafety cabinets, fermenters, roller culture apparatus and burners, and continuous flow centrifuges cell counters. Saksham’s principals include Carr Centritech, Castel Mac Spa, Chemometec, ESCO Micro, Hermle-Labortechnik, Hielscher, Jeiotech, Kaltis, Scanvac, Schuett Labortechnik, Scigenics, Steris and Tuttnauer. In fiscal 2009-10, Saksham signed an MOU with Steris, US, to promote their products in India. 41 Biohouse Solutions Head: Rupinder Singh (CEO) Life Sciences Revenue: Rs 7 crore Business: Distributor of life sciences research products Start-up Year: 1991 Address: Jaipuria Building, Kohla Pur Road, Kamla Nagar, New Delhi-110007 Tel: +91-11-23850876 Fax: +91-11-23854270 Website: www.biohouse.in Aims to achieve fast growth Biohouse Solutions serves healthcare institutions, life science researchers, clinical laboratories, and pharma and biotech industries. It caters to a variety of customers not only with products and services but also with solutions. In the FY 2009-10, the company reported revenue of Rs 7 crore and aims to achieve Rs 10 crore revenue target in FY 2010-11. Besides having branch offices in main Indian cities, the company has presence in Bangladesh, Pakistan and Sri Lanka through channel partners. The channel partners and their products that have been represented by Biohouse are Adam Equipments for weighing scales, moisture balances, balances and mass measuring equipments; Biohit for liquid handling products; Becton Dickinson Biosciences for antibodies, flow cytometers, tissue culture, and general plasticware; MP Biomedicals for life sciences, fine chemical and diagnostic products; Kerry Biosciences, Sheffield Pharma Ingredients, and AES CHEMIUNEX for microbiology tools; Roche Diagnostics for molecular biology and diagnostics products; Gen Chemical Corporation for manufacturing vaccine adjuvants; and Accelrys for bioinformatics and molecular modeling software. ]]> <![CDATA[36-38]]> https://biospectrumindia.com/news/95/2501/36-38.html https://biospectrumindia.com/news/95/2501/36-38.html Wed, 07 Jul 2010 13:11:00 +0530 36 JH Bio Innovations Head: Hari Kumar (CEO) Life Sciences Revenue: Rs 10.90 crore Business: supplier of scientific laboratory equipments Start-up Year: 1992 Address: No. 567, 2nd Cross, 2nd Block, RT Nagar, Bangalore-560032, Karnataka Tel: +91-80-23548433, 223434493/95 Fax: +91-80-23548981 Website: www.jhindia.com Targets spectrophotometer market JH Bio Innovations is a medium-sized innovative company that has operations in seven locations across India. In fiscal 2009-10, the company has registered revenue of Rs 10.90 crore as compared to Rs 13.10 in fiscal 2008-09. The company is one of the leading companies in India that has all India presence and working with some of the world leaders such as Thermo Fisher, Alpha Innotech Corporation, Operon Company, and Evogen. The product offerings of JH Bio include frontier technology product range to the low-end regular and standard instruments, reagents and technical solutions. Other products include electrophoresis, PCR, gel documentation systems, spectrophotometers, centrifuges, deep freezers, and freeze dryers. It also  offers high-end instrumentations such as real-time thermal cycler, liquid handling systems, and high-end imaging systems. J H Bio has significant market share in imaging systems and microvolume spectrophotometers across India. It has taken new initiatives to be the market leader in the whole range of UV-VIS spectrophotometer market with over 15 models and several world brands from Thermo Fisher Scientific. 37 Esco Biotech Head: Sameer Maheshwari (MD) Life Sciences Revenue: Rs 10.70 crore Business: Distributor of products by Esco Micro, Singapore Start-up Year: 2005 Address: No. 01- 102, Sita Nivas, Plot No. 94, Liberty garden, Malad (W), Mumbai-400064, Maharashtra Tel: +91-22-40730202 Fax: +91-22-28803738 Website: www.escoglobal.com Pumps investments in R&D Esco Biotech is a sole distributor of products manufactured by the Singapore-based company, Esco Micro. The products distributed by the company include Laminar Airflow, Class II and Class III Biosafety Cabinets, PCR cabinets, clean room construction components fume hoods, air showers, pass boxes, and air curtains. Esco Biotech launched the Esco CO2 Incubator this year. The company in India also provides services include housing trained service engineers who undertake installation, validation and servicing for all Esco products. The company has a growing patent portfolio with core competencies in embedded system, sensor and software, development and integration, containment engineering for biohazards, chemical vapors and hazardous powders, temperature, humidity, gas and environmental, and control-computational fluid dynamics. Compared to industry averages, Esco invests a significant percentage of annual revenues in research and development. Staff numbers include 70 engineers located in technology centers in Singapore, China, Indonesia and the US. 38 TechnoConcept Head: Rakesh Arora (CEO) Life Sciences Revenue: Rs 10.06 crore Business: Distributor of life sciences equipments and research products Start-up Year: 1995 Address: 824/3, Sukhdev Nagar, Kotla Mubarakpur, New Delhi–110003 Tel: +91-11-24636224/5 Fax: +91-11-24636223 Website: www.technoconcept.co.in Eyes proteomics-led growth TechnoConcept is known primarily for supply of peptide synthesizers and peptide reagents. It was started as a supplier of bioinformatics software and molecular biology products mainly made by the US and European manufacturers. In the last three years, the company has been promoting proteomics solutions in association with Proteomics International, Australia. TechnoConcept is a pioneer in providing chemistry-based software and indenting chemicals for peptide research in India. The company is the supplier of instruments such as peptide synthesizers, inhalation exposure system, cell disruptor, homogenizers, rotators, shakers and evaporators, automated multi-peptide synthesizers, micropore pumps. Currently, the company is in the process of extending its penetration to the international market and industries all over the country. Rakesh Arora, CEO of TechnoConcept, says, “We eye  the products which do not necessarily come from a worldwide established brand but also from the innovator companies who don’t have their plans to come directly to India and instead want marketing partners in India.” ]]> <![CDATA[33-35]]> https://biospectrumindia.com/news/95/1371/33-35.html https://biospectrumindia.com/news/95/1371/33-35.html Wed, 07 Jul 2010 13:10:00 +0530 33 B I Biotech India Head: Vinaya K Dubey  (CEO) Life Sciences Revenue: Rs 14.04 crore Business: Distributor of research reagents and instruments Start-up Year: 1984 Address: 325, 3 Floor, Ansal Chambers, Bhikaji Cama Place, New Delhi-110066 Tel: +91-11-2610271 Fax: +91-11-2610273 Website: www.biotechindia.com Maintains consistency in growth BI Biotech India has established itself as a major distributor of research reagents, consumables and equipments for proteomics, genomics, cell biology, immunology, health care and drug development. Its mission  is  to  deliver  superior  research  management  solutions  through  an excellent customer service and prompt technical support. With substantial increase in revenue every year, the company has maintained its growth consistently. In FY 2009-10, the company grossed the revenue of Rs 14.04 crore over the revenue of Rs 11.60 crore in the last fiscal. The company represents some of the US-based companies like Anaspec, Bellco Glass, GlobalStem, R & D Systems, RayBiotech, Santa Cruz, SABiosciences Corporation, and USA Scientific. Besides these, it also distributes products from; Abnova Corporation, Taiwan; Bachem AG, Switzerland; Cedarlane Laboratories, Canada; Major Science, Taiwan; and IKA, Germany. With a comprehensive range of products under its product portfolio, BI Biotech is fully-equipped to meet scientists/ researchers growing demand. 34 Trident Equipments Head: V Kamraj (MD) Life Sciences Revenue: Rs 13.50 crore Business: Supplier of scientific instruments Start-up Year: 1998 Address: 409/410 Kailas Industrial Complex, Park Site, Vikhroli(W), Mumbai-400079, Maharashtra Tel: +91-22-25181706 Fax: +91-22-25185463 Website: www.tridentequipments.com Impressive clients list Trident Equipments is engaged in the distribution of analytical, process and life sciences instrumentation. It represents companies in the field of electrochemistry, spectroscopy, color analysis, drug discovery, process analysis, biotechnology and microbiology. Trident’s clients list include big names such as UNICEF, NTPC, BARC, Reliance Energy, Ranbaxy, Dr Reddy’s Labs, AstraZeneca, Novartis, USV, NCL, IIT, ICAR and CSIR Labs, Ciba, Colorchem, Bayer, Colgate Palmolive, HLL, Emerson, and Yokogawa. In drug discovery, Trident’s product line include automated liquid handling platforms, pKa, LoGP and solubility determination, permeability measurement systems, and high throughput UV spectroscopy for DNA/RNA measurements. For biotech labs/industry, the products offered by Trident include CO2 incubator, deep freezers, shakers, water baths, fermenters, and roller bottle systems. For  microbiology labs/industry, the company offers air samplers and rapid identification systems. Lastly, in electrochemistry, it offers pH meters, conductivity, dissolved oxygen and ion meters. 35 Lonza India Head: Dr Harry Rathore (CEO) Life Sciences Revenue: Rs 12.20 crore Business: Production and suppliers of APIs both chemically as well as biotechnologically Start-up Year: 2007 Address: LBS Marg, Bhandup (West), Corpora, Mumbai-400078, Maharashtra Tel: +91-22-43424000, 67257464 Fax: +91-22-43424050 Website: www.www.lonza.com Targets nutrition ingredients Mumbai-based Lonza India clocked an annual sales of Rs 12.20 crore in fiscal 2009-10. The company currently  focuses on sales of the intermediates for the production of APIs used in the ARVs (anti-retrovirals) formulations for access-to-medicines markets under PEPFAR. Indian companies such as Aurobindo, Hetero, and Astrix are customers of Lonza’s ARV intermediates. Lonza India has  services and products offerings in the areas of cell discovery and molecular biology followed by sales and business development of disinfectant formulations for hospitals and pharma clean rooms under the Lonzaguard brand. Lonza is building the external-manufacturing-network of Indian companies to outsource production of small molecules to complement internal capacities of Lonza’s  API plants worldwide. Nutrition ingredients is the other major area where the company will be working upon and is currently exploring marketing opportunities in India. Lonza, which is   headquartered in Basel, Switzerland is a major player offering products and services spanning its customers’ needs from research to final product manufacture. ]]> <![CDATA[30-32]]> https://biospectrumindia.com/news/95/1102/30-32.html https://biospectrumindia.com/news/95/1102/30-32.html Wed, 07 Jul 2010 13:02:00 +0530 30 Biodigital Head: Vijay Bakhru (CEO) Life Sciences Revenue: Rs 27 crore Business: Distributor of life sciences equipments Start-up Year: 2000 Address: E-203, New Rajinder Nagar, New Delhi-110060 Tel: +91-11-28742189, 28742351 Fax: +91-11-28742189 Website: www.biodigitalindia.com Augments after-sales service Biodigital represents Syngene, Martin Christ, Dometic, Mennert, Biochrom, Kinematica AG, and Marvel Scientific, in India. The range of products offered by the company are in three market areas such as life sciences and biotechnology markets, pharmaceuticals and healthcare. The company has sales revenue of Rs 27 crore in fiscal 2009-10. It provides production scale freeze drying machines for the pharmaceutical industry. In the healthcare sector, the company provides cold chain and blood chain systems for storage and transportation of vaccines, blood and other thermo-labile substances. Biodigital has been concentrating on the excellent after-sales service to its esteemed customers through a team of well-trained service engineers. Application support is provided to the customers by the company as and when required through specialists in the respective fields. Also, the training is imparted to the service personnel at the principals' factories from time to time. The company also maintains a good inventory of critical spares so that in the event of a breakdown and fault, the downtime of equipment is reduced to minimum. 31 Biotron Healthcare Head: Venkatesh Voleti (Director) Life Sciences Revenue: Rs 56 crore Business: Drug discovery solutions, liquid handling and turn key solutions for molecular diagnostics Start-up Year: 1998 Address: 301, Coral Classic, 20th road, Chembur, Mumbai-400071, Maharastra Tel: +91-22-61406400 Fax: +91-22-25281012 Website: www.biotronhealthcare.com Extensive product portfolio Biotron Healthcare clocked an annual sales revenue of Rs 18.50 crore in fiscal 2009-10. In FY 2008-10, the company clocked revenue sales of Rs 13.50 crore. It has built a portfolio of products in the areas of drug discovery, liquid handling, genomics and molecular diagnostics. Its product range includes microplate multi-detection systems, liquid handling systems, rapid kit and biosensors manufacturing systems, compound storage and management systems, gene expression kits, PCR and qPCR systems and kits, kits for GPCR, kinases, inflammation and CNS, and automated nucleic acid extraction systems. The company has marketing alliances with BMG Lab Tech, Cepheid, PSS, CIS BIO, Sacace, Quanta, Panomics, Biodot, Ipsogen, and Matrical. Biotron's product line also includes compound and biological management and storage systems (upto -160 Deg and upto 50-lakh samples storage) from Matrical, US. As part of the agreement with Biodot, US, Biotron has installed unique liquid handling systems in virtually every rapid kit/biosensors manufacturing companies in India. 32 Techcomp India Head: Manmeet Singh (MD) Life Sciences Revenue: Rs 15 crore Business: Distributor of life sciences equipments Start-up Year: 2009 Address: 1005, (10th Floor), Pearl Best Height-1, Netaji Subhash Place, Pitampura, New Delhi-110034 Tel: +91-11-45686662/60/63 Fax: +91-11-45686663 Website: www.techcomp.com.sg Great first year of operation Techcomp India, a subsidiary of Techcomp (holding) Limited has a business focus on offering technologies in the field of life sciences, analytical instruments and biosafety products. Started in 2009, in India, the company caters to a number of industrial segments with a total turnover of Rs 20 crores in fiscal 2009-10. The life sciences group of Techcomp India in first two quarters of the year 2010 has given an impressive figures of Rs 15 crore and the company is targeting 30 percent growth during the year 2010. Despite starting its operation one year ago, the company was successful and it emerges as a leader for Hitachi brands of centrifuge by record order of Rs 9.3 crore ($2 mn) for 90 blood bank centrifuges across India for NACO project. The company has also emerged as market leader for its pre-fabricated bio-safety lab business with a total of 11 installations in India with three more upcoming projects in the coming months. Techcomp India has been a key supplier of Hitachi-Japan; Techne-UK; Jenway-UK; Stuart-UK; Friolabo-France and Bio-safety Labs from Techcomp. ]]> <![CDATA[27-29]]> https://biospectrumindia.com/news/95/5818/27-29.html https://biospectrumindia.com/news/95/5818/27-29.html Wed, 07 Jul 2010 13:01:00 +0530 27 3M India Head: Uday Matrubhutam (CEO) Life Sciences Revenue: Rs 40* crore *Biospectrum estimates Business: Manufacturer and supplier of fluid filtration solutions Start-up Year: 1988 Address: Concorde Block, UB City, 24 Vittal Mallya Road, Bangalore-560001, Karnataka Tel: +91-80-22231414/66595759 Fax: +91-80-22231450 Website: http://solutions.3mindia.co.in Fulfills filtration needs 3M is a global technology company delivering innovative solutions. It is an organization with more than 35 business units. The company supplies fluid filtration solutions (CUNO filtration systems) to biotech and pharma companies. The company’s life sciences business is approximately 10-12 percent of its total industrial business in India. The company’s life sciences revenue for the fiscal 2009-10 is estimated at Rs 40 crore. CUNO is one of the leaders in the design, manufacture and marketing of a comprehensive portfolio of filtration products for separation, clarifiction and purification of fluids and gases. CUNO provide effective and innovative solutions to suit all aspects of the pharmaceutical production scenario. From pre-filtration to final sterile filtration, for laboratory to mass production, CUNO has a solution to meet challenging filtration needs of the pharmaceutical industry. In biotechnology, the company offers solutions from clarification of cell culture-derived proteins to the purification of plasma-derived biologicals to cost-effective solutions to address diverse processing challenges. 28 Genaxy Scientific Head: Navneet Trehan (CEO) Life Sciences Revenue: Rs 31.50 crore Business: Biotechnology research products Start-up Year: 1999 Address: 155-156, C-Block, Community Center, Plot No. 32 to57, Behind Janak Cinema, Janakpuri, New Delhi-110058 Tel: +91-11-47619999 Fax: +91-11-25534163 Website: www.genaxy.com Consolidates product offerings Genaxy is a key player in the high throughput areas in India, with a market share of around 60 percent. In fiscal 2009-10, it has sales revenue of Rs 31.50 crore as against  Rs 29.50 crore last year. Genaxy entered into molecular biology reagents through its collaborations with Serva, Germany; Flourotechnic, Australia; and Germany-based The Gel Company, which is having a strong presence in the world market in capillary regeneration. In order to strengthen its market share in the molecular biology reagents, Genaxy has launched innovative range of taq polymerase, hot start taq, DNTPs, PCR master mixes and Q PCR master mixes. The company has also tied up with Qarta biotech, US, for the unique range of PCR products. The company is also entering the chromatography market with the SPE columns from Atiji. Genaxy has also added the water purification system from Arise into its product listing. Navneet Trehan, CEO, Genaxy, says, “Our focus, in future, will strongly be on proteomics and lab automation. We are also trying to enter into the heavy instruments and the blood banking (healthcare) segments.” 29 Newtronics Equipment Company Head: Navin Mehta (CEO) Life Sciences Revenue: Rs 29.70 crore Business: Development and production of pharma temperature and stability chambers for laboratories Start-up Year: 1980 Address: Near Hindustan Naka, Charkop, Kandivli (West), Mumbai-400067, Maharashtra Tel: +91-22-28679326 Fax: +91-22-28676059 Website: www.newtronic.in Gains stability with chambers Newtronic Equipment Company offers a range of products comprising humidity chamber or walk-in humidity chamber, cooling chambers or walk-in cooling chamber, photostabililty chambers, incubators, deep freezers, ultra low freezers, pharma refrigerators, laboratory and vacuum ovens. Newtronic’s stability chambers is especially suitable for carrying out stability test on drugs and drug substances according to current ICH Guidelines. In fiscal 2009-10, the company churned revenues of Rs 29.70 crore. Newtronic specializes in the development and production of pharma temperature and stability chambers for laboratories. It also looks at custom-designing its chambers. Its team of designers creates custom solutions using the best tools for highly-specialized requirements. Newtronic was awarded with the special recognition award for Outstanding Entrepreneurship in Micro & Small Enterprises (Manufacturing) at National Award 2009 held at Vigyan Bhavan, New Delhi, in 2009. Some of the certifications received by the company include ISO 9001:2008, CE Approval and it is also listed in Dun & Bradstreet Database. ]]> <![CDATA[21-23]]> https://biospectrumindia.com/news/95/2712/21-23.html https://biospectrumindia.com/news/95/2712/21-23.html Wed, 07 Jul 2010 12:56:00 +0530 21 Towa Optics Head: Rakesh Batra (CEO) Life Sciences Revenue: Rs 62.50 crore Business: Distributor of life sciences equipments Start-up Year: 1962 Address: 223, Okhla Industrial estate, New Delhi-110020 Tel: +91-11-26831936, 26834304 Fax: +91-11-26833426, 41613775 Website: www.towaoptics.com Excels in technology solutions From basic clinical microscope to the advance motorized microscope for research and diagnostic users, Towa Optics offers a wide range of sophisticated and high-tech microscopes for different category of users. Towa is the authorized distributor of many reputable international companies such as Nikon (Japan) for complete range of microscopes including confocal laser microscopes; Media Cybernatics (US) for imaging software; Fisher Scientific (UK) for histopathology equipments; Genikon, Italy, for complete solution for cytogenetic; Photometrics, (US) and Q Imaging, Canada, for high resolution CCD cameras and EMCCD cameras; and Spectro (US) for complete solution on used oil analysis. In the FY 2009-10, Towa Optics sales stood at Rs 62.50 crore as compared to Rs 56.09 crore in last fiscal. Rakesh Batra, CEO of Towa Optics, says, “It has been the endeavor of Towa to provide cutting-edge technology solutions to life sciences researchers. In Towa, we aspire to meet the needs of the customers but also provide customers with a new value that exceeds their expectation.” 22 Advanced Microdevices Head: Nalini Kant Gupta (MD) Life Sciences Revenue: Rs 56 crore Business: Production of microporous membranes and separation products Start-up Year: 1976 Address: No.20-21, Industrial Area, Ambala Cantt-133006, Haryana Tel: +91-171-2699290, 2699471 Fax: +91-171-2699221,2699008 Website: www.mdimembrane.com Manufactures finest materials Advanced Microdevices is the filtration and separation materials/devices manufacturer in India with an exceedingly vast range of products. It is a research-based company and the entire manufacturing technology has been developed in-house to produce variety of membranes having applications in sterilizing filtration in pharmaceutical and biopharmaceutical industries. It has sales revenue of Rs 56 crore in fiscal 2009-10 as against Rs 45 crore in fiscal 2008-09. The products of Advanced Microdevices are exported to more than 50 countries worldwide, including countries like the US, Western Europe, China, and South Korea. The company has deep penetration in Indian biopharma industry and enjoys dominant position in many product segments. The company has set up its overseas office in California, US, and work is going on for setting up a new joint venture company in the US. The company grows at a rate of over 25 percent and expects to maintain the same in the coming years.  A new 85,000 sq. ft. state-of-the-art GMP facility at a cost of Rs 20 crore is nearing completion. 22 Beckman Coulter India Head: Dr Chandrashekar  (MD) Life Sciences Revenue: Rs 52 crore Business: Manufacturer of biomedical testing instrument systems, tests and supplies that simplify and automate laboratory processes Start-up Year: 2006 Address: Solitaire Corporate Park, 3rd Floor, Bldg 11, Andheri-Ghatkopar Road, Chakala, Andheri East , Mumbai -400093, Maharashtra Tel: +91-22-30805133 Fax: +91-22-30805200 Website: www.beckmancoulter.com Strengthens stronghold in India Beckman Coulter India Private Limited (BCIPL) is a wholly-owned direct subsidiary of Beckman Coulter (BC), US. The Indian subsidiary of the company clocked an annual sales revenue of Rs 52 crore thus registering a growth of 12 percent in fiscal 2009-10. Prior to establishing a direct subsidiary in India, for 16 years, the company was represented in India through a reputed distribution channel. The company caters to the Indian diagnostic industry, biopharmaceuticals, discovery research and government funded research institutes, pharmaceuticals and allied industries. Around 60 percent of the subsidiary’s business comes from diagnostics while 40 percent comes from life sciences. A major proportion of the company’s clients come from the public sector. BCIPL had achieved major breakthroughs in 2009 for high-end laboratory automation systems and capillary electrophoresis in the biopharma customer segment. The year 2006 was a landmark year for the company, as it tripled its business in India apart from coming up with some major breakthroughs in centrifugation. ]]> <![CDATA[Forges ahead with separation business]]> https://biospectrumindia.com/news/95/1574/forges-ahead-with-separation-business.html https://biospectrumindia.com/news/95/1574/forges-ahead-with-separation-business.html Wed, 07 Jul 2010 12:54:00 +0530 20Nishotech Head: Sanjay Badani (CEO) Business: Supplies separation technologies and filtration systems Start-up Year:1989 Address: W-199-E, MIDC, Thane Belapur Road, Navi Mumbai-400705, Maharashtra Tel: +91-22-41515151 Fax: +91-22-41515150 Website: www.nishotech.com Life Sciences Business (in Rs Crore) Rs 70 Crore Nishotech along with its technology partners offers turn-key solution for various purification and separation needs of its customers Nishotech provides solutions to pharma and biopharma companies with design and project management services Nishotech clocked an annual life sciences revenue of Rs 70 crore for the fiscal 2009-10. In the life sciences space, Nishotech looks at separation technologies by offering customized filtration, separation and purification solutions with technology portfolio of membranes, chromatography and ion exchange to industries like pharma, biopharma, sugar, dairy, starch, automotive and mechanical as well as chemical industry. In the pharma and biopharma space, Nishotech-Novasep association provides separation and purification solutions using membrane and prep-chromatographic technologies. Part of Rs 1,997 crore (â‚¬350 mn) Novasep Group (Groupe Novasep), Novasep Process SAS primarily concentrates on purification needs of pharmaceutical, food, cosmetic, agrochemical and specialty chemical industries; using industrial processes. Novasep Process offers solutions for producing pure products, right from process development to optimization, and from the supply of laboratory purification equipment to the delivery of industrial turn-key purification plants. Through synergies with Novasep Synthesis, Novasep Process technologies enable straight-forward and cost-efficient global synthesis of new molecules, while helping to reduce time-to-market. Novasep Process' core technologies are chromatography, crystallization, ion exchange, membranes and evaporation. Dr MÃ¼ller AG, Switzerland, is a technology partner for Nishotech for their patented candle filtration design. Nishotech also specializes in delivering the required quality and flow rate of pharmaceutical water as per the URS according to standards set by the US FDA,UK MHRA and TGA. Nishotech provides solutions to pharma and biopharma companies with design and project management services wherein engineers from the company help their clients in planning and executing the state-of-the-art facilities. Nishotech along with its technology partners offers turn-key solution for various purification and separation needs of its customers. The company provides complete support such as designing erection, installation and commissioning and also undertakes AMCs. Nishotech is also known for its sterile process piping systems. ]]> <![CDATA[Leading-edge products providers]]> https://biospectrumindia.com/news/95/6817/leading-edge-products-providers.html https://biospectrumindia.com/news/95/6817/leading-edge-products-providers.html Wed, 07 Jul 2010 12:52:00 +0530 19Eppendorf India Head: V Sankarnarayanan (CEO) Business: Developer and distributor of life science instruments Start-up Year:2003 Address: Doshi Towers, 4th Floor, 156, Poonamallee High Road, Kilpauk, Chennaiâ€“600010, Tamil Nadu Tel: +91-44-42111314 Fax: +91-44-42187405 Website: www.eppendorf.co.in Life Sciences Business (in Rs Crore) Rs 73.63 Crore Apart from life sciences research or industry, Eppendorf also focuses on classical or standard PCR needs of agricultural sector Eppendorf's products target academic and commercial research institutes, and industries related to biotech Eppendorf India is the Indian arm of Eppendorf AG, Germany. Headquartered in Chennai, Eppendorf India has branch offices in all the major cities in the country. The company recorded revenue of Rs 73.63 crore in FY 2009 over the previous years' revenue of Rs 60.14 crore. The range of products offered by Eppendorf India includes pipettes, dispensers, centrifuges, and also consumables like sample tubes and pipette tips. In addition, Eppendorf offers instruments and systems for cell manipulation, automated devices for liquid handling, complete equipment for DNA amplification and biochips. Eppendorf India develops, produces and distributes systems for use in life sciences research laboratories worldwide. Its products are aimed at academic and commercial research institutes as well as industrial companies in the field of biotechnology or in other sectors that use biotech research processes. The company offers wide range of PCR machines and consumables. The traditional Mastercycler series of Eppendorf are available in three models such as, Mastercycler Gradient, Mastercycler and Mastercycler Personal. In PCR consumables space, Eppendorf offers products like twin.tec PCR plates (both 96 wells and 384 wells), 0.2ml PCR tubes, heat sealer, sealing film, sealing mat, cap strips, capping aid, PCR tube rack and PCR cooler. Apart from life sciences research or industry, agriculture is one of its focus segments for classical or standard PCR. In 2007, New Brunswick Scientific became a member of the Eppendorf Group. New Brunswick manufactures a wide range of equipment for cell growth, detection and storage, with products ranging from biological shakers, fermenters and bioreactors to CO2 incubators and ultra-low temperature freezers. Eppendorf India sells the entire range of Eppendorf and NBS products in India. The attraction of the Eppendorf's Indian headquarter is its applications lab and a training center. It has facilities to train customers on specific high-tech topics such as real-time PCR and liquid handling automation. Moreover, the lab also serves for demonstration purposes as a continuing exhibition of the state-of-the-art research tools. ]]> <![CDATA[Builds business alliances for growth]]> https://biospectrumindia.com/news/95/2295/builds-business-alliances-for-growth.html https://biospectrumindia.com/news/95/2295/builds-business-alliances-for-growth.html Wed, 07 Jul 2010 12:49:00 +0530 17Toshvin Analytical Head: Nakul Toshniwal (MD) Business: Specializes in analytical and laboratory equipment for life sciences industries Start-up Year:1948 Address: 103, SJ House, 1st Floor, Sitaram Mills Compound, NM Joshi Marg, Lower Parel, Mumbai-400011, Maharashtra Tel: +91-22-23015096 Fax: +91-22-23013592 Website: www.toshvin.com Life Sciences Business (in Rs Crore) Rs 85.10 Crore In addition to its ties with Shimadzu, Toshvin has initiated its partnerships with TKA-Germany, and Restek Corporation-US Toshvin operates through 12 offices and provides effective, efficient marketing and service support Specializing in analytical and laboratory equipments for life sciences, Toshvin Analytical represents some of the leading global companies in India. Toshvin represents Shimadzu exclusively in India for the following range of products: UV/Vis spectroscopy, FTIR and AA spectrophotometers, gas chromatographs (GC), and GC mass spectrometers (GCMS), thermal analyzers, spectrofluorophotomers, particle size analyzers, and ICP spectrometers. In 2010, Toshvin celebrates its 40 years of partnership with Japan-based Shimadzu Corporation, one of the world's largest instrumentation companies. In addition to the partnership with Shimadzu, Toshvin has extended its business ties with TKA, Germany, for the range of high purity laboratory water purification systems; and Restek Corporation, US, for chromatography columns and accessories. Adequate stock of spares and consumables are maintained by Toshvin and the dedicated service support is available for customers from Toshvin Service Centers, which are supported by 350 installations all over India. Toshvin's partnership with Restek Corporation, US, enables it to provide chromatography accessories and consumables. Restek specializes in suppling GC and HPLC columns and accessories with an extensive range of products for routine as well as specialized applications. Toshvin also offers customer support services and has a client-base of over 5,000 customers, including some of the largest companies in the pharma and life sciences industries - both Indian and MNCs, leading research institutes and most of the premiere universities in India. Toshvin operates through a network of 12 offices and provides effective, efficient marketing and service support to customers all over the country. Application support to customers is provided through close cooperation with Shimadzu India's Customer Support Center's located in Mumbai and New Delhi. The support services provided by Toshvin include instrument demonstrations, analytical method developments, customer training and troubleshooting. The lab is staffed with highly trained and experienced personnel for efficient application support and training. ]]> <![CDATA[Rides a steady growth curve]]> https://biospectrumindia.com/news/95/6769/rides-a-steady-growth-curve.html https://biospectrumindia.com/news/95/6769/rides-a-steady-growth-curve.html Wed, 07 Jul 2010 12:46:00 +0530 16DSS Imagetech Head: Arvinder Dhingra (CEO) Business: Suppliers of clinical lab, biotech research instruments and tools Start-up Year:1965 Address: A-5, Mohan Cooperative Industrial Area, New Delhi-110044 Tel: +91-11-30886763 Fax: +91-11-41678694 Website: www.dssimage.com Life Sciences Business (in Rs Crore) Rs 88.08 Crore DSS enjoys a unique position as the most informed supplier of microscopes and digital imaging solutions in the country DSS Imagetech has grown at a steady pace and it aspires to become a complete solution provider From a small family-owned business to steadily becoming a contemporary business group, DSS Imagetech has come a long way to create a niche for itself. This 50-year-old company in the biosupplier field is providing cutting-edge technology solutions to researchers and clinicians in different areas of life sciences. The product range and application areas include microscopy, image analysis software systems, genetic workstation, DNA probes and microarray readers. The international companies that DSS represents in India under its micro-imaging division are Olympus (Japan), Tokai Hit (Japan), Andor Technology (UK), Jenoptik (Germany), Molecular Machines & Industries (Switzerland), MBF Bioscience (US), and Genetix (UK). The life sciences division of the company represents Abbott Molecular (US), Dako (Denmark), TaKaRa Clontech (Japan), Macherey Nagel (Germany), Fluidigm (US), Carestream Molecular Imaging (US), Digilab Genomic Solutions (US), Nomadics (US), and Non Linear Dynamics (UK). The medical division of the company represents Olympus Medical Systems, CAE Healthcare (Canada), and GMV Corporation (Spain). Micro-imaging division is the oldest division of DSS and is the backbone of the company. DSS enjoys a unique position as the most informed supplier of microscopes and digital imaging solutions in the country. The company focuses on various instruments and equipment such as biological microscopes, image analysis systems, cooled/non-cooled scientific cameras and cytogenetic equipments. DSS continues to provide training in the field of IHC, FISH and advance imaging through its training division, to enable the customer to hone their experimental skills. To tap the rapidly growing medical and surgical market in India, DSS recently set up its medical division and tied up with Olympus Medical Systems for their gastroenterology and bronchoscopy products for the North and East India. The company has an association with CAE Healthcare, Canada; and GMV Corporation, Spain; for their surgical simulators to provide TouchSense haptic technology that provides a realistic, engaging, and multi-sensory learning experience for medical education. ]]> <![CDATA[From selling to launching products]]> https://biospectrumindia.com/news/95/2550/from-selling-to-launching-products.html https://biospectrumindia.com/news/95/2550/from-selling-to-launching-products.html Wed, 07 Jul 2010 12:44:00 +0530 15Genetix Biotech Asia Head: Arun Prakash (CEO) Business: Technical support and distribution of life sciences products Start-up Year:1989 Address: 71/1, Shivaji Marg, New Delhi-110015 Tel: +91-11-41427031 Fax: +91-11-25419631 Website: www.genetixbiotech.com Life Sciences Business (in Rs Crore) Rs 90 Crore From a turnover of Rs 20,000 in 1990 to Rs 90 crore in 2010, Genetix has become one of the largest life science distribution companies in India With a move towards manufacturing and developing new products, Genetix is now all set to capture new markets Incorporated in the year 1989, Genetix Biotech Asia, started as an indenting company that moved into distribution in 1996, and manufacturing in 2008. Genetix has had the credit of bringing some of the best life sciences companies into India for the first time as brands such as Bio-rad, Stratagene, Qiagen, Invitrogen, Nunc-Nalgene, Hyclone and JRH. From a turnover of Rs 20,000 in year 1990 to Rs 90 crore in 2010, Genetix has become one of the largest life sciences products distribution companies in India. In 2009, after acquiring the business of manufacturing and global distribution of Thermo Cyclers from Corbett Research, Australia; Genetix became the first Indian company to manufacture PCR machines and export that to 35 countries worldwide (excluding the US). The company has set up a state-of-the-art moulding facility in North India, with an investment of over Rs 41.80 crore ($9 mn), for molecular biology and cell culture products. Genetix has plans to set up developing and manufacturing facilities for many molecular biology reagents and kits to reduce its dependence on international suppliers. Genetix caters to over 1,300 customers in India and overseas. The company is optimistic about crossing Rs 110 crore sales in the current fiscal and is also committed to enhance its image as the most preferred supplier of consumables and instruments to the biotech research and vaccine production market segment. Talking about the future strategy, Arun Prakash, CEO, Genetix Biotech Asia, says, â€œWe have been able to establish ourselves as strong distributor over-the-years and now have moved successfully into the manufacturing as well. The year 2010, would be a landmark in the history of Genetix as its focus moves from selling the international brands into launching its own products in India and Asian sub-continent.â€? In fiscal 2009-10, the company invested in further expansion of R&D laboratory for the development of a number of new products. The company also does validation and troubleshooting for products imported and regularly organizes demonstrations for the scientists during workshops or seminars on emerging technologies. ]]> <![CDATA[Adopts stratagy of value-addition]]> https://biospectrumindia.com/news/95/1375/adopts-stratagy-of-value-addition.html https://biospectrumindia.com/news/95/1375/adopts-stratagy-of-value-addition.html Wed, 07 Jul 2010 12:42:00 +0530 14RFCL Head: Sushil Mehta (MD) Business: Manufactures and markets fine chemicals and lab kits Start-up Year:2005 Address: A-3, Okhla Industrial area, Phase-I, New Delhi-110020 Tel: +91-11-41609171-75 Fax: +91-11-41609189 Website: www.rfcl.in Life Sciences Business (in Rs Crore) Rs 93.23 Crore RFCL is aggressively building its business with the support of R&D, product development and manufacturing to offer value-added products and services to the customers With the surge of investments, RFCL looks forward to grow at a CAGR of 23 percent in next four years RFCL Limited, owned by ICICI Venture Funds Management Company and managed by a group of professionals, focuses on two strategic business units â€“ Rankem Scientific Laboratory Solutions and Diagnova. These two business segments cover a range of customer segments including pharma, biotech, R&D labs, food processing, in vitro diagnostic facilities in clinical labs, hospitals, and nursing homes. RFCL has recorded a CAGR of over 25 percent in sales revenue for the last four years. However, for the fiscal 2009-10, the company's revenue stood at Rs 93.23 crore as compared to Rs 92.21 crore last year, when the company had achieved a phenomenal growth clocking Rs 34.04 crore in fiscal 2007-08. Driven by its vision of â€œLeveraging science to provide solutions for a better lifeâ€?, RFCL is aggressively building both its businesses backed by R&D, product development and manufacturing to offer value added products and services to its target customers. The company has recently unveiled its new mid-term plan, Sprint 2014, which will enable RFCL to grow at a CAGR of 23 percent for the next four years. In micro-life portfolio (dehydrated culture media), Rankem has added 64 products, which will give wider spectrum to different application areas. In molecular biology segment, the addition of 47 products will be completing the basket of fermentation area, where the purity and accuracy is now defined at upstream process. According to new practices in fermentation technology, now more emphasis is given to upstream process to reduce the end product cost and to increase efficiency of the drug. RFCL also entered into a strategic partnership with Integrated DNA Technologies (IDT), US, for the marketing of custom nucleic acids to the Indian researchers. The company has plans to invest on building in-house manufacturing for diagnostic products and laboratory chemicals. The company has already commissioned a dedicated manufacturing plant for diagnostics in Dehradun. In addition, a new lab chemical manufacturing plant is currently under erection stages at Panoli, Gujarat. ]]> <![CDATA[Charting ambitious growth plans]]> https://biospectrumindia.com/news/95/4741/charting-ambitious-growth-plans.html https://biospectrumindia.com/news/95/4741/charting-ambitious-growth-plans.html Wed, 07 Jul 2010 12:40:00 +0530 13Sartorius Stedim India Head: Amit Chatterjee (CEO) Business: Laboratory and process technology provider Start-up Year:1991 Address: No.10, 3rd Phase, Peenya 6th Main, KIADB Industrial Area, Bangalore-560 058, Karnataka Tel: +91-80-27700351 Fax: +91-80-27723183 Website: www.sartorius-stedim.com Life Sciences Business (in Rs Crore) Rs 95 Crore Sartorius offers the widest and best integrated portfolio in the industry for manufacturing pharmaceuticals using single-use and hybrid systems Sartorius Stedim has invested about Rs 28.52 crore in India for expanding its competencies and capabilities The Sartorius Group is an internationally-leading laboratory and process technology provider covering biotechnology and mechatronics segments. The company reported sales of Rs 95 crore from its life sciences business in FY09 as against Rs 90 crore in FY08. Though the downturn affected Sartorius, the company still went ahead with its ambitious growth plans and investments in making India the center of excellence for its Asian market requirements. About Rs 28.52 crore (â‚¬5 mn) has been invested in India for expanding the competencies, capability and capacity to serve the group and Asian market requirements. Since the beginning of this year, the company has seen large orders for core equipments for large biopharmaceutical plants. In production technology, the biopharmaceutical industry is currently witnessing a complete paradigm shift. The industry is increasingly switching from stainless steel equipment to single-use products. As a market-focused organization, Sartorius has been strategically heading and propelling developments to create a portfolio of products and services to serve its customers with a total solutions approach. While the equipment business slowed down in line with the economic sentiments, the consumable and single-use devices saw a significant growth. The industry really promoted the membrane-based chromatography devices which saw it move from R&D through process development into commercial production in several customers in vaccine industry. The trend towards single-use fluid handling bags, connectors and more critically, the bioreactors, was quite evident as the industry looked to reduce its capital costs and speed up its expansion and development time. With the best-in-class design, engineering, manufacturing, process control and application support competencies in India, the company offers the widest and best integrated portfolio in the industry for the manufacture of pharmaceuticals using single-use and hybrid systems. The company is optimistic that it would be launching highly attractive new products for the biopharmaceutical industry and R&D in 2010 as well. ]]> <![CDATA[Poised for a leap in Indian market]]> https://biospectrumindia.com/news/95/2070/poised-for-a-leap-in-indian-market.html https://biospectrumindia.com/news/95/2070/poised-for-a-leap-in-indian-market.html Wed, 07 Jul 2010 12:39:00 +0530 12Merck Head: Dr Marek Dziki (CEO) Business: Supplier of pharmaceutical and chemical products Start-up Year:2005 Address: Lloyds Centre Point, 1st Floor, Appasaheb Marathe Marg, Prabhadevi, Mumbai-400025, Maharashtra Tel: +91-22-67944309 Fax: +91-22-64944309 Website: www.merck.co.in Life Sciences Business(in Rs Crore) Rs 97* Crore * BioSpectrum estimates In India, Merck's chemical products offering fulfills the needs of both industrial production as well as research Merck, through its manufacturing facility in Goa, is the only manufacturer of Guaiazulene, TDS and Oxynex ST In India, Merck is represented by the companies and production sites including Merck India, Merck Specialities and its manufacturing site in Goa. Merck Limited (formerly E Merck Limited) was set up in India in 1967; which was the first Merck Group company in Asia. It went public in 1981 and was the first Merck Group company to do so. Merck Specialities is the Indian sales organization of the global Merck Group of Darmstadt, Germany. It supplies the Indian market with high-quality pharma and chemical products. Established in 2005, Merck India is wholly-owned by Merck KgaA. In India, Merck's chemical products offering fulfills the needs of both industrial production as well as research. Major products in chemicals include reagents, analytical chromatography, food and water analysis products, microbiology and hygiene products. Merck, through its manufacturing facility at Goa, is the only manufacturer of Guaiazulene, Thiamine Disulfide (TDS) and Oxynex ST, in addition to being the largest manufacturer of vitamin E in India. Its new dehydrated culture media plant in India is the first plant outside Germany. Last year, Merck KGaA announced the acquisition of Bangalore Genei (India) Private Limited (BGIP) by its wholly-owned subsidiary in India, Merck Specialities, from the Sanmar Group. BGIP is located in Bangalore and specializes in the development, production, marketing and sales of products for proteomic and genomic research. With more than 100 employees, the company generated total revenues of Rs 20.20 crore in fiscal year 2008-09. Commenting about the acquisition, Christina Shasserre, Global Head of Merck's bioscience business, says, â€œBGIP's leadership in the Indian academic market, a segment with high growth potential, will ideally complement our existing customer base. BGIP's product portfolio comprises a wide-range of bioscience products, which are tailored to the needs of the domestic market in India.â€? The company was also in the news, with its parent company acquiring Millipore Corporation, based in Billerica, Massachusetts, US, for Rs 33,400 cr ($7.2 bn). ]]> <![CDATA[Reach out to global customer base]]> https://biospectrumindia.com/news/95/1548/reach-out-to-global-customer-base.html https://biospectrumindia.com/news/95/1548/reach-out-to-global-customer-base.html Wed, 07 Jul 2010 12:37:00 +0530 11Sigma Aldrich India Head: Raja Ram (MD) Business: Manufacturer and supplier of chemicals, biochemicals and equipment Start-up Year:1991 Address: Plot # 12, Bommasandra Jigani Link Road, Bangalore-560100, Karnataka Tel: +91-80-66219400 Fax: +91-80-66219450 Website: www.sigmaaldrich.com/india.html Life Sciences Business(in Rs Crore) Rs 100* Crore * BioSpectrum estimates Sigma Aldrich's global reach is a competitive advantage in sourcing and distribution. With world-class logistics capabilities, it supports customers quickly and efficiently Sigma Aldrich India's research campus is a testament to the success of its approach in serving global customers Sigma Aldrich India is the Indian subsidiary of Sigma-Aldrich Corporation. Sigma's India revenue from life sciences business for FY09 is estimated at Rs 100 crore. The company has a broad customer base of commercial laboratories, pharmaceutical companies, industrial companies, universities, diagnostics companies, biotechnology companies, hospitals and governmental institutions. Sigma-Aldrich Corporation is a leading life sciences and high technology company. The company develops, manufactures, purchases and distributes the wide range of high-quality chemicals, biochemicals and equipment throughout the world. These chemical products and kits are used in scientific research, including genomic and proteomic research, biotechnology, pharmaceutical development and as key components in pharmaceutical, diagnostic and other high technology manufacturing. The company operates in 38 countries, and manufactures 48,000 of the 130,000 chemical products it offers. The company also offers 40,000 equipment products and sells that in over 160 countries, servicing over 92,000 accounts representing over one million individual customers. The company has four business units including research units of essentials, specialties and biotech, and the fine chemicals unit, SAFC. The units are closely inter-related in their activities and have earned a reputation for quality and performance. The 48,000 products manufactured by the company contribute to about 65 percent of its global sales, with the remainder sourced through its network of over 10,000 suppliers. Each of its products, whether manufactured or procured, is analyzed and quality tested to rigid specifications before being packaged in one of its 31 plants located in 11 countries. Sigma's global reach is a competitive advantage in sourcing and distribution. With world-class logistics capabilities, it supports customers quickly and efficiently, supplying materials they need for their research and manufacturing. In 2010 and beyond, the company plans to build and implement additional localized strategies, including increased sales force specialization for specific areas, and special focus on the life sciences, analytical and manufacturing markets. ]]> <![CDATA[Improves commercial footprint in India]]> https://biospectrumindia.com/news/95/1487/improves-commercial-footprint-in-india.html https://biospectrumindia.com/news/95/1487/improves-commercial-footprint-in-india.html Wed, 07 Jul 2010 12:34:00 +0530 9GE Healthcare Life Sciences Head: Anurag Gupta (MD) Business: Life sciences products, services and processes Start-up Year:1994 Address: 6th Floor, Tower C, Golden Enclave, (Old) Airport Road, Bangalore-560017, Karnataka Tel: +91-80-42071403, 25279538 Fax: +91-80-42071422 Website: www.gelifesciences.com Life Sciences Business(in Rs Crore) Rs 120* Crore * BioSpectrum estimates GE Healthcare Life Sciences has a portfolio of ready-to-use systems and devices designed for biopharma production GE Healthcare Life Sciences has significantly increased its focus on life sciences business in India GE Healthcare works in the primary areas of healthcare systems (diagnostic imaging and clinical systems), medical diagnostics, surgery, healthcare IT solutions and life sciences. Last year, the company substantially increased its commercial footprint and service capabilities in India to cater to the customers' needs faster and more efficiently. Headquartered in the UK, GE Healthcare is a unit of General Electric Company. Worldwide, GE Healthcare employs more than 46,000 people and serves healthcare professionals and their patients in more than 100 countries. In fiscal 2009-10, the life sciences revenue of the company is estimated at Rs 120 crore. Though the company experienced a slow growth in 2009, it continues its lead in some of the key segments like chromatographic media and proteomic platforms. GE's Biacore range of products (used in protein interaction studies) is a popular one. GE Healthcare Life Sciences has been a key supplier of bioprocess, protein purification, chromatography, columns, media and filtration needs to the major players in India in the biotech space. With around 30 years of experience in biopharmaceuticals, GE's products and solutions are renowned for their standard in biopharmaceutical production. The company has a very strong commercial team in India with offices in Bangalore, Delhi, Chennai, Mumbai, Hyderabad, Kolkata, Lucknow, Pune and Chandigarh. And a highly competent service team to serve customers better and faster. The presence of R&D and training facilities and Fast Trak Global Services at the GE John F Welch Global Research Center at Bangalore further complements their commercial operations, and this is the key to providing complete solution for various needs of all their Indian customers. GE Healthcare Life Sciences has a portfolio of ready-to-use systems and devices designed for biopharmaceutical production. The ready-to-process portfolio is a range of products designed to meet the biopharmaceutical industry's need for increased speed, simplicity and safety for all areas of bioprocessing - from cell culture and fermentation to final purification. ]]> <![CDATA[Service backed with global standards]]> https://biospectrumindia.com/news/95/2897/service-backed-with-global-standards.html https://biospectrumindia.com/news/95/2897/service-backed-with-global-standards.html Wed, 07 Jul 2010 12:28:00 +0530 6Millipore India Head: Sudhir Kant (President) Business: Manufacturer and supplier of up/downstream products Start-up Year:1986 Address: 50A, 2nd Phase, Ring Road, Peenya, Bangalore-560058, Karnataka Tel: +91-80-39224000 Fax: +91-80-28396345 Website: www.millipore.com Life Sciences Business (in Rs Crore) Rs 177.02 Crore Millipore's products are backed with service support through the company's extensive network of sales offices in India Millipore India's life sciences and lab water business units help customers improve laboratory productivity Millipore India, a wholly-owned subsidiary of the Millipore Group with its world headquarters in Massachusetts, US registered sales revenue of Rs 177.02 crore in fiscal 2009-10 as against Rs 160.30 crore in fiscal 2008-09. Millipore India has three business units for bioprocess, life sciences and lab water. The Indian operation of the company is headed by its president Sudhir Kant from Bangalore, where the company has its manufacturing and research facilities. The bioprocess team of Millipore India has partnerships with the drug and vaccine manufacturers for providing high performance and innovative products/services spanning downstream and upstream processing. In 2004, the company sets up India's first validation and PDS lab in Bangalore. Over the years, the lab has been recognized by customers as a world-class facility with dedicated technical experts providing expert advice in areas such as validation, process optimization, scale up studies for commercial manufacturing, enhancing manufacturing productivity, training and consultancy services. The life sciences and lab water business units of Millipore India help customers improve laboratory productivity and workflows. The life sciences unit helps customers prioritize potential drugs, products and technologies to support R&D activities in life sciences. Millipore's lab water business unit offers a comprehensive range of laboratory water purification systems including the world famous Milli-Q range. The latest introductions based on the integral platform have set a new standard in most laboratories in the country. The products are backed with extensive service support through the company's extensive network of sales offices in India. In the area of drug discovery, Millipore has an in-depth understanding of key target classes for selectivity testing, including kinase, GPCR and ion channel profiling assays. The company also offers validated RIAs, ELISAs, and multiplex assays plus bio-analytical support for research. Millipore's extensive panels of antibodies and reagents help researchers in the areas such as cancer, apoptosis and diabetes. ]]> <![CDATA[Maintains lead in flow cytometry]]> https://biospectrumindia.com/news/95/8223/maintains-lead-in-flow-cytometry.html https://biospectrumindia.com/news/95/8223/maintains-lead-in-flow-cytometry.html Wed, 07 Jul 2010 12:25:00 +0530 5Becton Dickinson Head: Sunit Trivedi (Director - Biosciences) Business: Supplier of diagnostic, bioresearch and medical equipments Start-up Year:1994 Address: 6th Floor, Signature Towers, B South City 1, Gurgaon-122001, Haryana Tel: +91-124-2383566 Fax: +91-124-2383224 Website: www.bd.com/india/ Life Sciences Business (in Rs Crore) Rs 180* Crore * BioSpectrum estimates Becton Dickinson is a leader in the flow cytometry segment, commanding almost 85 percent of the market share in India Becton Dickinson looks at opportunities in biosciences, nanotech, AIDS monitoring and immunization for growth Becton Dickinson (BD) is a US-based company that manufactures and sells a broad range of medical supplies, devices, laboratory equipments and diagnostic products used by healthcare institutions, life sciences researchers, clinical laboratories and industry. BD operates in India through a wholly-owned subsidiary, BD India. BD is focused on improving drug therapy, enhancing the speed of diagnosing infectious diseases, and advancing research and discovery of new drugs and vaccines. According to BioSpectrum estimation, the revenue of the company for the fiscal year 2009-10 excluding the diagnostics is Rs 180 crore. The company is a leader in the flow cytometry segment commanding almost 85 percent of the market share in India. In August 2009, BD launched the BD Kaleidoscope reagent and dye expansion program-marked by the initial release of nearly 200 new fluorochrome-conjugated antibodies for flow cytometry to help meet today's life sciences research needs. The company has also made innovative changes in FACSAria II, used for studies on stem cell therapy and sorting, by adding 375 lasers to it and making it more cost-effective. BD is also looking at new areas for the application of Influx, a product that was added to the company's portfolio through its acquisition of Cytopia in 2008. BD's product range primarily finds application in experimental stem cell therapy, a new concept in the field of stem cell research, but can also be used in nanobiotech, marine biotech and sterile experimental stem cell therapy. CD4 percentage, a unique product for AIDS monitoring launched last year does both the CD4 count and percentage in a single run. Path way 855, another product, was launched last year for high content cell imaging experiments. In 2008, BD bagged a major tender for 60 instruments from Government of India for AIDS monitoring. The company has also strongly emphasized on education in the field of flow cytometry through its center of excellence for flow cytometry set up in collaboration with the National Center for Biological Sciences (NCBS) in Bangalore. BD focuses on biosciences, nanotech, and AIDS monitoring and immunization for capitalizing the new opportunities. ]]> <![CDATA[Set to diversify into reagents manufacturing]]> https://biospectrumindia.com/news/95/4190/set-to-diversify-into-reagents-manufacturing.html https://biospectrumindia.com/news/95/4190/set-to-diversify-into-reagents-manufacturing.html Wed, 07 Jul 2010 12:17:00 +0530 3Spinco Biotech Head: C Ravindranath (CEO) Business: Distributor of analytical instruments Start-up Year:1981 Address: PB No. 6114, No. 4 Vaidyaram Street, T.Nagar, Chennai-600017, Tamil Nadu Tel: +91-44-24340057 Fax: +91-44-24340761 Website: www.spincotech.com Life Sciences Business (in Rs Crore) Rs 250.68 Crore High-end innovative mass spectrometry solutions are the new value-addition Spinco offers to its customers Along with customer support, Spinco is also planning to diversify into life sciences reagents manufacturing Spinco Biotech reinforces its leadership in distribution business by clocking annual life sciences revenue of Rs 250.68 crore in FY 2009-10. The company focuses on providing enterprise-wide laboratory solutions from global technology leaders. Spinco functions under five strategic business units â€“ life sciences, mass spectrometry, chromatography, lyo and lab products, and chemistry and consumables. The year 2010 is a milestone year for Spinco, as it has crossed 10,000 Shimadzu HPLC installations in India. To commemorate this occasion, the company is inaugurating a 50,000 sq.ft. customer support center in Hyderabad. This facility will house state-of-the-art customer training center, demo/application labs, inventory stock center, and sales and technical support operations. High-end innovative mass spectrometry solutions are the new value-addition Spinco offers to its customers. Spinco's life sciences business has witnessed extraordinary growth in last fiscal with the value- partnership of GE Healthcare Life Sciences for their entire research and imaging portfolio. Whereas in genomics, proteomics, cell-biology or drug discovery, Spinco offers both instrumentation and consumables from global leaders such as Affymetrix, GE, Molecular Devices, Shimadzu Biotech, USB, Aapptec, Wyatt, Golden Helix and XRAY-Biotique. Spinco's lyo division provides turn-key freeze drying solutions to pharma and vaccine manufacturers enabling their exports to regulatory markets with stringent compliance needs. PAT/NIR and process homogenization solutions are also offered with on-site application support. The company has warehouses in Chennai and Hyderabad to provide door delivery of complete instruments and consumables either duty paid or through customs-bonded warehousing. These facilities are ISO 9001 certified and offer complete column chemistry and molecular biology reagents/kits. Spinco Genomics Lab in Chennai is equipped with complete Affymetrix microarray platform and other instrumentations. With an emphasis on customer support, Spinco enhanced its infrastructure with 28 offices and 350 employees. The company is also diversifying into life sciences reagents manufacturing later this year. ]]> <![CDATA[Cashing-in on chromatography biz]]> https://biospectrumindia.com/news/95/1718/cashing-in-on-chromatography-biz.html https://biospectrumindia.com/news/95/1718/cashing-in-on-chromatography-biz.html Wed, 07 Jul 2010 12:14:00 +0530 2Agilent Technologies Head: Parmeet Ahuja (President and Country General Manager) Business: Lab equipments and research products Start-up Year:1989 Address: Agilent Technologies India, Plot No. 10, Udyog Vihar, Phase IV, Gurgaon-122016, Haryana Tel: +91-124-4727000 Fax: +91-124-4727102 Website: www.agilent.com Life Sciences Business (in Rs Crore) Rs 255* Crore * BioSpectrum estimates With improvisations product portfolio, Agilent is clearly on its way to consolidate its position in the Indian market Agilent has consolidated its chromatography and mass spectrometry businesses to maintain lead in the market The life sciences sector has been one of the key growth areas for Agilent India. The growing awareness and requirements from the regulatory stand point, both in the pharma and non-pharma segments, have been the strong driving forces behind the company's rapid growth. The company's strong global presence and reliability as a solution provider have made an increasing number of Indian customers look upon Agilent as their reliable partners in the growth path. According to BioSpectrum estimates, Agilent Technologies' life sciences business, in FY 2009-10, stood at Rs 255 crore. A major share of the revenue comes from the pharma sector which has been a large contributor to the Agilent's Life Sciences and Chemical Analysis (LSCA) business. Agilent's core strength has been its chromatography business. Agilent also introduced its next generation Agilent 7100 Capillary Electrophoresis (CE) system, providing at least 10 times more sensitivity than any other commercial CE instrument. Its industry-benchmarked 1200 series HPLC and 7890 GC have been its biggest revenue generators. Agilent's Rapid Resolution LC (RRLC), a fast LC, has been a big success in the pharma segment. Agilent also launched 1120 Compact LC, a product for the mid range market segment and the product received a positive feedback and the orders for the same are on the rise. In 2009, Agilent Technologies signed a definitive MoU with the Indian Institute of Science, Bangalore and the Society for Innovation & Development to form Agilent Measurement Science Center (AMSC). The center would focus on scientific research, technology and equipment development and training activities to explore new frontiers in measurement science. Over the years, Agilent's mass spectrometry (LCMS and GCMS) products have also seen a big jump in revenues. Today, Agilent is one of the few players, which has a total portfolio of mass spectrometry techniques that span the various application needs of the industry. With the instrumentation needs growing, its portfolio of lab informatics solutions, like the enterprise content management, OpenLAB and Electronic Lab Notebook, has also showed high double digit growths. ]]> <![CDATA[Retains lead in supplier market]]> https://biospectrumindia.com/news/95/1622/retains-lead-in-supplier-market.html https://biospectrumindia.com/news/95/1622/retains-lead-in-supplier-market.html Wed, 07 Jul 2010 12:10:00 +0530 1Waters India Head: KV Venugopalan (President) Business: Manufacturer and supplier of analytical instruments and solutions Start-up Year:1988 Address: 36A, II Phase, Peenya Industrial Area, Bangalore-560058, Karnataka Tel: +91-80-28371900 Fax: +91-80-28392157 Website: www.waters.com Life Sciences Business (in Rs Crore) Rs 262.2 Crore In spite of difficult external market and economic conditions, Waters business in India continues to enjoy the confidence and support of majority of its customers With a sales turnover of Rs 262.20 cr, Waters India has retained its No.1 position for the second time in a row Bangalore-based Waters India has recorded revenue of Rs 262.20 crore in fiscal 2009-10 as against Rs 333.70 crore in fiscal 2008-09. In spite of difficult external market and economic conditions, Waters business in India continues to enjoy the confidence and support of majority of its customers, which made it rise to the number one position in the BioSpectrum-ABLE Industry Survey 2010. Even though the company's business declined by close to 20 per cent in 2009 as compared to 2008, Waters enjoyed a major share of the LC and LCMS markets. Even in a difficult year like 2009, when most companies in the sector initiated cost-cutting measures such as salary cuts and employee reduction, Waters not only provided excellent salary increases but also continues to recruit persons to prepare itself for the future challenges. KV Venugopalan, president of Waters India, says, â€œOur results so far in 2010 prove beyond doubt that the measures we have taken have yielded excellent results not only in increasing employee morale and loyalty, but also our business.â€? He shares, â€œInitial indications from the market and our results so far says that the Indian economy is recovering faster than expected and our customers particularly those in the pharma sector have started large scale investments to clear their entire capital expenditure backlog to regain lost time and accelerate their growth process. As a result, we expect our business also to grow in high double digits for the year 2010.â€? Waters India is the Indian subsidiary of Waters Corporation headquartered in Massachusetts, US. It is a member of the Standard and Poors 500 Index. The company employs more than 4,500 with manufacturing facilities located in Milford, Massachusetts, Taunton, Massachusetts, Wexford, Ireland, Singapore and Manchester, England. Pioneering a combined portfolio of separations science, laboratory information management, mass spectrometry and thermal analysis, Waters technology breakthroughs and laboratory solutions provide an enduring platform for its customer success. While the company offers a broad array of technologies, it still maintains platform products in four key areas such as instruments, chemistries, software, and services. ]]> <![CDATA[GEAC approves 17 Bt crops for trials]]> https://biospectrumindia.com/news/95/1656/geac-approves-17-bt-crops-for-trials.html https://biospectrumindia.com/news/95/1656/geac-approves-17-bt-crops-for-trials.html Fri, 18 Jun 2010 16:30:00 +0530 Even as the moratorium announced by Environment Ministry against Bt brinjal in February 2010 continues, the biotech regulator has approved field trials of 17 new genetically modified (GM) crops in the country, bringing smiles to the BioAgri industry and frown on the faces of anti-GM activists. The Genetic Engineering Appraisal committee (GEAC) in its 100th meeting held on May 12, 2010, gave permission to confined field trials of 17 transgenic crops expressing new genes. GEAC considered 17 applications from various organizations including many publicly funded institutes and few companies, and granted permission to all of them for the field trials of the transgenic crops under confined conditions. Earlier the Review Committee on Genetic Manipulation (RCGM) had recommended all these applications to GEAC. In this meeting, GEAC gave go ahead for confined field trials to analyze the effect of Azotobacter mutant strains on wheat in terms of yield, protein content, and biomass by National Research Centre on Plant Biotechnology (NRCPB), Indian Agricultural Research Institute (IARI), New Delhi. Indian Institute of Horticultural Research (IIHR), Bangalore was granted permission by GEAC to conduct event selection trials on five transgenic crops. Those include the transgenic watermelon, resistant to Watermelon Bud Necrosis Virus (WBNV); transgenic tomato (Lycopersicon esculentum L), resistant to Tospo virus (Peanut Bud Necrosis Virus: PBNV); transgenic tomato (Lycopersicon esculentum L), resistant to Tomato Leaf Curl Virus (TLCV); transgenic tomato (Lycopersicon esculentum L) with combined resistant to Tomato leaf Curl Virus (TLCV) and Tospo (Peanut Bud Necrosis Virus: PBNV:PBNV); and transgenic papaya for evaluating disease resistance and yield. The regulatory body also gave its nod to conduct event selection of transgenic hybrid Rice (Oryza sativa L.) SPT maintainer by M/s. E. I. DuPont India Private Limited, Hyderabad. Permission to conduct event selection trials on transgenic Sugarcane (Saccharum L.) containing cry-1Ab gene for borer resistance by Sugarcane Breeding Institute (ICAR), Coimbatore was also granted. The permission to conduct event selection trials on transgenic Sorghum (Sorghum biocolor L. Moench) containing mtID gene for drought and salinity tolerance by Central Research Institute for Dryland Agriculture (ICAR) , Hyderabad was also given. The committee gave permission to conduct Bio-safety Research Level-1 (BRL-1) second year field trial on two transgenic corn hybrids namely Hishell and 900M Gold containing stacked events MON 89034 & NK603 at 11 SAU by Monsanto India, New Delhi. Also, the extension was granted for second year BRL-1 trials of transgenic corn hybrids to two more locations during Rabi 2010 by Monsanto. Bayer Biosciences, Gurgaon was granted permission to conduct event selection trials on 56 transgenic rice events containing cry1Ab, cry1Ca and bar genes. Again the permission was given for trials of transgenic potato resistant to Potato Virus Y by Indian Agricultural Research Institute (IARI), New Delhi. Also the permission to conduct Biosafety Research Level-1 (BRL-1) trials on two transgenic maize hybrids namely 30V92HR and 30B11HR with indigenously produced seeds containing cry1F & PAT and CP4EPSPS genes (TC1507XNK603 (DAS-01507-1) X MON-00603-6) at seven SAUs by Pioneer Overseas Corporation, Hyderabad Bejo Sheetal Seeds, Jalna was permitted to conduct Biosafety Research Levels (BRL-I) second season trials with Bt Brinjal hybrids expressing cry1Fa1 gene (event 142) and Bt Brinjal hybrids expressing cry1Fa1 gene (event 142) for production of leaves and fruits of Bt Brinjal for sub-chronic feeding studies. GEAC also gave permission to Maharashtra Hybrid Seeds Company Ltd. (MAHYCO) to conduct Biosafety Research Trials (BRL-II) on Bollgard II X Roundup Ready Flex (BGIIRRF) cotton hybrids containing cry1Ac &cry2Ab and CP4EPSPS (events MON 15985XMON 8913). Besides these approvals for conducting trials, the committee in the follow up action on Review of Bt Brinal Event EE-I also discussed and decided that the Chairman of GEAC will convene a meeting with eminent scientists and experts and members of GEAC in July 2010 to deliberate on the need for additional studies to assess the safety of Bt brinjal Event EE-1. The meeting is supposed to discuss the requirement of additional studies and the required protocols and procedures to be followed. It was also decided that the review on Bt brinjal will be science based and would be completed in a time bound manner. Rahul Kaul in New Delhi ]]> <![CDATA[BioInformatics grows at sluggish pace]]> https://biospectrumindia.com/news/95/4450/bioinformatics-grows-at-sluggish-pace.html https://biospectrumindia.com/news/95/4450/bioinformatics-grows-at-sluggish-pace.html Fri, 18 Jun 2010 16:13:00 +0530 The smallest segment of the Industry, BioInformatics which has just about 2 percent segment share in the overall industry, has been sluggish in FY 2009-10. It registered a 5 percent growth over 2008-09, clocking Rs 231 crore in revenues last year as compared to Rs 220 crore in FY 2008-09, when it recorded a growth of 16 percent. The pure-play BioInformatics companies in India include Strand Genomics, Ocimum Biosolutions, SysArris, CytoGenomics and Molecular Connections. These companies have come out with products that cater mainly to the needs of the pharmaceutical and biotechnology companies. Most of these companies are small and medium enterprises based at locations such as Bangalore, Hyderabad, Pune. ]]> <![CDATA[BioIndustrial to grow over 15% for next 5 years]]> https://biospectrumindia.com/news/95/1138/bioindustrial-to-grow-over-15-for-next-5-years.html https://biospectrumindia.com/news/95/1138/bioindustrial-to-grow-over-15-for-next-5-years.html Fri, 18 Jun 2010 16:06:00 +0530 The BioIndustrial market mainly comprising industrial enzymes is estimated to be Rs 564 crore in the year 2009-10 as against Rs 478 crore in 2008-09. The segment grew 16 percent in FY 2009-10. Though the overall enzyme consumption figures of India are comparatively low with respect to other countries and 60-70 percent of domestic demand is imported, the segment on an average has been growing over 15 percent in the last five years. In India, the industrial enzyme consumption is predominantly in the detergents market (40 percent), followed by the starch market (25 percent). The other important segments are food and feed, textiles, leather, pulp and paper. In recent years, enzymes have found numerous applications in the food, pharmaceutical, diagnostic and chemical processing industries. The trend for their application in almost every sector is on increase. The leading players in this segment include Novozymes which has over 50 percent market share followed by Advanced Enzyme Technologies holding 25-30 percent market share. Other important players are Maps, Genecor, Lumis and Kerry Biosciences. Besides, a new entrant Anthem Cellutions, a part of Anthem Biosciences group has gained significant market share over a short period of time. Apart from focusing on the local market, companies like Advanced Enzyme Technologies are looking at other markets such as China. Considering the potential opportunity in the other markets Advanced Enzyme has registered good growth in its export sales. The Indian companies are reporting a good growth, a lot of R&D is happening in these companies and new applications are being explored. Indian companies are looking at technologies from Europe, China and Australia. However, with respect to global enzyme industry India still needs to do a lot of catching up. ]]> <![CDATA[Slow recovery for Indian biotech]]> https://biospectrumindia.com/news/95/2266/slow-recovery-for-indian-biotech.html https://biospectrumindia.com/news/95/2266/slow-recovery-for-indian-biotech.html Tue, 15 Jun 2010 12:23:00 +0530 Is the Indian biotech industry chugging slowly out of the recessionary mode? This is a question that has been asked within the industry for some time now. Some partial answers are available with the results of the 8th BioSpectrum-ABLE Biotech Industry Survey. The highlights are available in this issue of BioSpectrum. The industry has achieved a modest growth rate of 17 percent to cross the Rs 14,000 crore mark for the first time in 2009-10. Will the industry go back to the days of heady growth of 30 percent or more in the near future? Most industry leaders agree that the industry is maturing and an annual growth of around 20 percent will be something everyone will be extremely happy with. There are reasons for this mature approach. One, the industry's base has been increasing and so high growth numbers are not very easy to achieve. Two, the growth is based mainly on the good showing by the BioServices and BioAgri sectors with the dominant BioPharma segment not in a position to keep pace with the rest of the industry. As a globally connected industry, with 53 percent of the revenues coming from exports, in dollar terms the overall industry size has been fluctuating with the value of the US currency. Thanks to the depreciation of the Rupee in the last 12 months, the export-dominant industry has raked in good numbers to cross the $3 billion mark for the first time. However, the expectation of reaching $5 billion in revenues in 2010 has not happened. Biotech is not the first industry in the country to go through such a phase. What is heartening is-the biotechnology ecosystem has become strong in the last five-six years. Two key players who are part of the ecosystem are the technology providers to the industry and the biotech education sectors. The revenues of these two segments are currently not counted as part of the survey for industry size. These two segments will have revenues close to $1 billion and they too are on way to make strong recovery thanks to the increasing investments in the biotech industry, by government-led infrastructure building and industry investments. There has been some churn in the BioSpectrum-ABLE Top 20 list with Biocon regaining its No.1 slot after four years thanks to some good revenues from its European operations and also the market acceptance of its recently introduced innovative products. The survey has captured the revenues of more than 60 companies this time, compared to only 50 in the previous years. With just a few publicly listed companies, revenue details are hard to get and in the case of many private organizations, BioSpectrum team has estimated the revenues based on information gathered from multiple sources. BioServices sector is clearly a strong player now and there is now a move towards further expansion to become regional players. So, many of these companies are in the process of expanding their footprint to South East Asian countries and this has become a differentiator for many. The trend will continue for some more time, along with a drive for consolidation too within the industry. The moratorium on Bt brinjal and the uncertainty over regulatory approval for genetically-modified (GM) foods has not had much impact on the BioAgri industry's performance last year. The industry is waiting for the correct signals from the regulator and the recent regulatory approval to conduct field trials of 17 crops has sent out mixed signals about the future prospects for this sector. Also, the added public scrutiny over GM products due to the relentless campaign against Bt brinjal has added to the misery of the industry. There is now a clamor for further reduction in prices of Bt cotton with the demand to scrap the technology fee charged by the innovator. This is certainly a sector that is in for some interesting times ahead. Overall, there is cautious optimism within the biotech industry and the recent government efforts to boost the infrastructure and support for various industry initiatives have been highly appreciated. I am inclined to believe that the worst is over for the industry and things can only go well from here. Group Editor <sureshn@cybermedia.co.in> ]]> <![CDATA[48-50-JK Agri Genetics Ltd-Strand Life Sciences-Suven Life Sciences Limited]]> https://biospectrumindia.com/news/95/6654/48-50-jk-agri-genetics-ltd-strand-life-sciences-suven-life-sciences-limited.html https://biospectrumindia.com/news/95/6654/48-50-jk-agri-genetics-ltd-strand-life-sciences-suven-life-sciences-limited.html Tue, 15 Jun 2010 12:23:00 +0530 48 JK Agri Genetics Ltd President P S Dravid Business Involved in R&D and marketing of agri biotech products (Bt cotton seeds) Start-up Year 1989 Biotech Revenue Rs 35 crore Address 1-10-177, 4th floor, Varun Towers, Begumpet, Hyderabad – 500016 Tel + 91-40-66316858 Fax +91-40-27764943 Website www.jkseeds.net JK Agri Genetics Ltd.(JKAL), an erstwhile division of JK Tyre & Industries Ltd, clocked a total turnover of Rs 35 crores in 2009-2010. It was established in 1989 with its headquarters at Hyderabad, Andhra Pradesh. The company is concentrating on research and development, production, processing and marketing of hybrid seeds of sorghum, pearl millet, maize, cotton, rice, sunflower, tomato, okra and hot pepper. There are many hybrids marketed by the company. But fast moving hybrids are JK 99, JK DURGA, JK 666, JK INDRA, JK Varun (555), JK Chamundi. JK Agri Genetics got approval to launch its Bt cottonseeds in 2006 has sold 2.5 lakh packets. The company has been working on several genes for various traits like biotic and abiotic strains. It is also working on number of other crops for developing salinity/drought tolerant hybrids. It is building up its R&D as well as marker-assisted selection with novel traits with the help of biotechnology tools. 49 Strand Life Sciences Chairman & Ceo Dr Vijay Chandru Business Bioinformatics Start-up Year - Biotech Revenue Rs 35 crore Address 5th Floor, Kirloskar Business Park, Bellary Road, Hebbal, Bangalore-560024 Tel +91-80-40787263 Fax +91-80-40787299 Website www.strandls.com Life science informatics company Strand Life Sciences has registered a total revenue of Rs 35 crore in the fiscal year ended March 31, 2010. Strand leverages its core strengths and intellectual property in data mining, predictive modeling, bioinformatics, and computational chemistry to develop products and solutions for drug discovery. Five of the top ten pharmaceutical companies, three of the top six biotechnology companies, and numerous academic institutions across the globe, are part of Strand’s customer profile. Leveraging its unmatched interdisciplinary scientific expertise with its decision enabling technologies, Strand empowers biomedical and research scientists gain deep insights from raw data. Strand offers products and services in the areas of omics-based technologies, drug discovery, predictive systems modeling and knowledge management. 50 Suven Life Sciences Limited CEO Venkat Jasti Business Drug discovery Start-up Year 1989 Biotech Revenue Rs 33.5 crore Address Serene Chambers, Road No. 5, Avenue - 7, Banjara Hills, Hyderabad-500 034, Andhra Pradesh Tel +91- 40-23541142 Fax +91-40-2354-1152 Website  www.suven.com Suven Life Sciences Limited, is a biopharmaceutical company specializing in drug discovery and developmental activities in Central Nervous System disorders. The revenues for the year ended Mar’ 2010 from drug discovery and R&D services stood at Rs 33.5 crore compared to Rs 21.03 crore for the corresponding previous year. Including CRAMS business, revenue stood at Rs 129.8 crore. Suven’s major thrust on innovative R&D in Drug Discovery continues with a total spending of Rs 34.16 crore (26 per cent on revenue) for the year ended Mar’ 2010 which lead to growth in R&D costs by 16 percent. During the quarter there were major qualitative achievements in granting a product patent from USA (US 7,649,097) and a product patent (EP 1919896) from European Union for Suven’s drug discovery pipeline which consists of 12 molecules on 6 targets in CNS arena which are at various stages of preclinical and clinical development and these patents are valid until 2025 in addition to the clinical candidate SUVN-502 for Alzheimer’s and Schizophrenia. ]]> <![CDATA[45-47-Clinigene-Hester Biosciences-Max Neeman International]]> https://biospectrumindia.com/news/95/3167/45-47-clinigene-hester-biosciences-max-neeman-international.html https://biospectrumindia.com/news/95/3167/45-47-clinigene-hester-biosciences-max-neeman-international.html Tue, 15 Jun 2010 12:22:00 +0530 45 Clinigene CMD Dr Kiran Mazumdar Shaw Business Clinical research Start-up Year 2000 Biotech Revenue Rs 39 crore Address Clinigene House, Tower 1, Semicon Park, Electronic City, Phase II, Bangalore-560100 Tel +91-80-28082728 Fax +91-80-28522989 Website www.clinigeneintl.com Clinigene International, the clinical research arm of biotech major Biocon, has grossed Rs 39 crore as revenue for the fiscal year ended March 31, 2010. Clinigene  is a full-service CRO that partners global pharma and biotech companies in their clinical development programs. Established in 2000, Clinigene became India’s first CAP accredited Central Laboratory followed by NABL accreditation in 2003. Clinigene’s services now span a broad spectrum of activities—human pharmacology, clinical operations, clinical development, clinical data management and  biostatistics, regulatory, bioanalytical research and central laboratory services supporting early phase through late-phase clinical development programs. All activities are carried out in strict compliance with regulatory and ICH GCP requirements. Its comprehensive investigator database and expertise in many therapeutic areas helps in providing faster patient recruitment, cost competitive trials, yet world-class clinical support. 46 Hester Biosciences CEO & MD Rajiv Gandhi Business Manufacturing of Poultry Vaccines Start-up Year 1997 Biotech Revenue Rs 37.53 crore Address 16/10 Devendra Society, Naranpura, Ahmedabad-380013 Tel +91-79-27680476 Fax +91-79-27682250 Website www.hesterbiosciences.co.in Veterinary vaccines manufacturer, Hester Biosciences has registered an annual turnover of Rs 37.53 crore in fiscal 2009-2010. Located near Ahmedabad, Hester is ISO 9001-2000 and GMP certified. The product range includes 39 types of poultry vaccines, 28 types of live and 11 types of inactivated poultry vaccines. Hester has a state-of-the-art facility to produce live and inactivated veterinary vaccines.  It has a capacity to manufacture over five billion doses of animal vaccines, with the current capacity utilization at 35 percent. Apart from export of vaccines, Hester  imports one vaccine from the US.  Exports are currently done to three countries and registration is pending in over 10 countries.  Besides marketing its own vaccines, Hester represent companies like Merial, US and Biopharm, Czech Republic for poultry vaccines; and Synbiotics, US for animal diagnostic kits for the Indian market.  Hester currently is also looking at establishing a base either in the US or Europe as a means to achieve its global ambitions. 47 Max Neeman International MD Deepak Kapoor Business Production and marketing of poultry biologicals Start-up Year 1991 Biotech Revenue Rs 36.94 crore Address Corporate Heights, SCO-24, Sector-14, Gurgaon-122 001 Tel +91-124-22315045 Fax - Website  www.indovax.com The accumulated revenue for Indovax for the fiscal 2009-2010 is Rs 36.94. Indovax has been engaged in the production of poultry biologicals since 1991. Its product portfolio consists of viral and inactivated vaccines. Some of them are Newcastle vaccine (Ranikhet vaccine), Gumboro vaccine (IBD), Marek’s vccine, infectious bronchitis vaccine, fowl pox vaccine, fowl cholera vaccine and infectious coryza vaccine. It has a modern state-of-the-art facility spread over 14 acres in a completely poultry-free zone. The company has been focusing on  introducing  a new product every six months. Indovax in joint venture with Gezondheidsdienst voor Dieren BV, a Dutch entity and one of the world’s largest veterinary diagnostic laboratories are executing a collaborative biotechnology project to produce SPF Embryonated eggs and Diagnostic reagents. The Project under execution in Himachal Pradesh is supported by the Dutch Government. ]]> <![CDATA[42-44-Maps India-Ocimum Biosolutions-Max Neeman International]]> https://biospectrumindia.com/news/95/2518/42-44-maps-india-ocimum-biosolutions-max-neeman-international.html https://biospectrumindia.com/news/95/2518/42-44-maps-india-ocimum-biosolutions-max-neeman-international.html Tue, 15 Jun 2010 12:21:00 +0530 42 Maps India MD Piyush Palkhiwala Business Producer and exporter of industrial enzymes Start-up Year 1975 Biotech Revenue Rs 45 crore Address 302, Shapath-3, Near GNFC Info Tower, Sarkhej-Gandhinagar Highway, Ahmedabad - 380054 Tel +91-79-26859971-74 Fax +91-79-26859975 Website www.mapsenzymes.com Maps India, a producer and exporter of industrial enzymes, has reported a total revenue of Rs 45 crore in the financial year 2009-2010. With over 150 employees, sophisticated production plant and a dedicated R&D center, it has become a key player in enzymes and microorganisms. A team of 30 scientists is involved in R&D activities at Maps India. It produces a broad range of enzymes and microorganisms at its full-scale production plant spread across 57000 Sq. mt.  Maps’ enzymes include amylases, proteases, cellulases, xylanase, glucoamylase, pectinase, catalase and phytase, which are used in versatile industries like textile, leather, baking, alcohol, brewing, detergent, starch and animal feed. Its microorganisms products are used in various applications for effluent treatments, cleaning and odor control, waste degradation, bioaugmentation and bioremediation, and aquaculture. The company has been investing about Rs 10 crore in Gujarat for expanding its operations. In this regard it has signed a Memorandum of Understanding with the state government. 43 Ocimum Biosolutions CEO Anuradha Acharya Business Bioinformatics tools and services Start-up Year 2000 Biotech Revenue Rs 41.47 crore Address 6th Floor, Reliance Classic, Road No 1, Banjara Hills, Hyderabad - 500 034 Tel +91-40-5562 7200 Fax +91-40-5562 7205 Website www.ocimumbio.com Ocimum Biosolutions has reported sales revenue of Rs 41.47 in the current fiscal year as compared to Rs 47.57 crore in the previous fiscal. The company has invested over Rs 2 crore R&D and so far has filed 65 international patents with seven granted. Ocimum currently has a manpower of 155 people. Ocimum Biosolutions provides comprehensive (research level and GLP-compliant) genomic services, reference databases, and LIMS solutions. Ocimum’s distinct platform “Research as a Service” (RaaS) allows complete outsourcing of genomics – from storing biological samples and performing on demand DNA and RNA based services to validating biomarkers using its proprietary databases and providing data and bioinformatic analysis. The company has been chosen as a global preferred outsourcing provider for more than 75 percent of top 25 pharmaceutical and biotechnology companies and leading research institutes. With its global infrastructures, standardized procedures, capacity, and highly skilled staff, the company is capable of supporting drug development programs from pre-clinical target development and toxicogenomic assessment to clinical biomarker identification and patient stratification. 44 Max Neeman International CEO Dr Ajoy Kumar Business Clinical research services Start-up Year 2001 Biotech Revenue Rs 40 crore Address Max House, 1 Dr Jha Marg, Okhla III, New Delhi-110020 Tel +91-11-40772100 Fax +91-11-26322846 Website  www.neeman-medical.com Max Neeman International, subsidiary of the Max India Group provides full range of clinical research services with focus on phase I, II, III and IV trials for drugs, devices, nutraceuticals and cosmetics in compliance with ICH GCP standards. The company has accumulated Rs 40 crore as revenue in last financila year. Max Neeman is based out of six regional offices and has 175 active sites in 22 cities with access to over 900 GCP trained investigators. 90 percent of the total employees are physicians (MDs) and ICH GCP trained. Max Neeman is a 9001:2008 certified organization for site management, monitoring and data management and ISO 27001 certified for Information Security Management System. The company has evolved into a full service CRO over the past nine years and has followed a process of continuous development. It has successfully completed four US FDA audits for highest enrollment globally and has been successfully audited around 40 times by the sponsor companies. ]]> <![CDATA[39-41-Wockhardt-Anthem Biosciences-Wyeth India (Now Pfizer India)]]> https://biospectrumindia.com/news/95/7368/39-41-wockhardt-anthem-biosciences-wyeth-india-now-pfizer-india.html https://biospectrumindia.com/news/95/7368/39-41-wockhardt-anthem-biosciences-wyeth-india-now-pfizer-india.html Tue, 15 Jun 2010 12:06:00 +0530 39 Wockhardt MD Mr Habil F Khorakiwala Business Pharmaceutical and Biotechnology business Start-up Year Mid 1960s Biotech Revenue Rs 60 crore Address Wockhardt Towers, Bandra Kurala Complex, Bandra (East), Mumbai-400051 Tel +91-22-26596258 Fax +91-22-26596801 Website www.wockhardt.in For  the past four decades, Wockhardt’s forte has been it’s pharmaceutical and biotechnology business which is backed by  top research-oriented technology. The biotechnology unit carved out as a separate  strategic unit. Its biotech  revenues for the year ended  March 31, 2010,clocked at Rs 60 crore. Wockhardt’s pioneering efforts in biotechnology led to the launch of three successful products in the Indian market - Biovac-B (hepatitis B vaccine), Wepox (erythropoietin), and Wosulin (recombinant insulin). The company has also made a breakthrough with Glargine (a novel long-acting insulin). Wockhardt is well prepared to tap the biogenerics opportunity, which is powered by its vision to introduce one biopharmaceutical product every year. This is backed by robust manufacturing, regulatory and marketing infrastructure, offering huge opportunities for outsourcing and potential alliances with biotechnology leaders in the US and Europe. Its current R&D locations are spread out to Wockhardt – Aurangabad and Mumbai; Negma Laboratories – France; Morton Grove Pharmaceuticals – Illinois, US; and Wockhardt - UK and Pinewood, Ireland. 40 Anthem Biosciences CEO Ajay Bharadwaj Business Contract research services Start-up Year 2006 Biotech Revenue Rs 53 crore Address #49, Canara Bank Road, Bommasandra Industrial Area Phase I, Bommasandra, Hosur Road, Bangalore - 560099 Tel +91-80-40444000 Fax +91-80-40444020 Website www.anthembio.com Anthem Biosciences is a Bangalore based DRAP (Discovery Research Alliance Partner) dedicated to supporting research efforts in the discovery of new compounds by pharmaceutical, biotechnology, specialty chemicals, agriculture chemicals and material science companies. Anthem has achieved a revenue of Rs 32.34 crore for its first full year of operation in 2008-09 and reported an annual turnover of Rs 53 crore in 2008-09. The company hopes to cross the target of Rs 80 crore for the current financial year. With its best in class infrastructure, Anthem Biosciences can do GMP synthesis from milligram to kilogram and multi-kilogram scale. Apart from modern well equipped labs, the company has a cGMP kilo lab and a versatile GMP pilot plant. Anthem Biosciences is located in an industrial park in Bangalore with a built capacity to house 250 researchers. Currently the company employs over 200 people with plenty of room left for adding extra capacity in labs and people. The overall investments in Anthem have been to the tune of Rs 40 crore. 41 Wyeth India (Now Pfizer India) CEO Kewal Handa Business Biologics, animal healthcare products and consumer  healthcare Start-up Year 2003 Biotech Revenue Rs 53 crore Address Level 6 & 7, Platina, Plot No C-59, ‘G’ Block, Bandra - Kurla Complex, Bandra (E), Mumbai 400 098, India Tel +91-22-26574000 Fax - Website  www.wyethindia.com Wyeth India is a subsidiary of  the US-based  pharmaceutical giant, Wyeth and now acquired by Pfizer. It has clocked a a revenue figure of Rs 53 crore  (purely from its vaccine business) for the financial year 2009-2010. In the beginning of 2009, its parent company was in news with its acquisition by  pharma giant Pfizer for a whopping $68 billion thus blending its biotech portfolio with Pfizer’s  pharma product profile. The company has a strong presence in oral contraceptives, folic acid and depilatory cream. It was the first to launch hormone therapy. In the field of vaccines, Wyeth introduced vaccines against HIB and invasive pneumococcal disease in the country. Enbrel, a breakthrough treatment for rheumatoid arthritis; Rapamune, an immuno suppressant for prevention of rejection after renal transplant; Prevenar, a pneumococcal conjugate vaccine; and Tygacil, the world’s first glycilcycline antibiotic, are among internationally known products launched by Wyeth in India. The company has a state-of-the-art manufacturing facility in Verna, Goa. ]]> <![CDATA[36-38-Nath Bio-Genes-Aventis Pharma India-Dr Reddy's Laboratories]]> https://biospectrumindia.com/news/95/7703/36-38-nath-bio-genes-aventis-pharma-india-dr-reddys-laboratories.html https://biospectrumindia.com/news/95/7703/36-38-nath-bio-genes-aventis-pharma-india-dr-reddys-laboratories.html Tue, 15 Jun 2010 12:05:00 +0530 36 Nath Bio-Genes MD Nandkishor Kagliwal Business Engaged in research, processing and producing hybrid seeds including Bt seeds Start-up Year 1981 Biotech Revenue Rs 85 crore Address Nath House, Nath Road, Aurangabad - 431 005 Tel +91-240-2376314 Fax +91-240-2376188 Website www.nathseeds.com Nath Bio-Genes, a hybrid seed producing and biotechnology company clocked an annual revenue of Rs 85 crore in 2009-2010. In addition to direct sales, it has sub-licensed the technology to other companies. The sub-licensees includes companies such as Unipho Seeds and Biogenetics, Zuari Seeds, Navkar Seeds, Sri Rama Agri-Genetics, and Daftari Agro. Nath Bio-Genes, independently as well as jointly with its sister organization Global Trangenes, have forged R&D linkages with several renowned institutions in the world. The company undertakes seed production in over 30,000 acres of land with about 25,000 farmers in the states of Andhra Pradesh (AP), Gujarat, Karnataka, Maharashtra, Rajasthan and Tamilnadu. The company has elaborate seed processing facilities at Aurangabad, Coimbatore, Medchel (AP) and Munipally (AP) for ginning, delinting, processing, treating, packing and storage of seeds. 37 Aventis Pharma India CEO Dr Shailesh Ayyangar Business Manufacturing and marketing of pharma products Start-up Year - Biotech Revenue Rs 68.34 crore Address Aventis  House, 54/A, Sir Mathuradas, Vasanji Road, Andheri East, Mumbai-400093 Tel +91-22-28278000 Fax +91-22-28370939 Website www.aventispharmaindia.com Aventis Pharma clocked a total sales of Rs 68.34 crore in 2009-2010. In February 2009, there was a discontinuance of distribution of the anti rabies vaccine, Rabipur which led to a slight drop in its total revenues. During the fiscal, its insulin brand, Lantus had a sales growth of 38.6 percent. It presently  has a market share of 8.7 percent in this segment. It has become the third largest insulin brand in the last quarter of 2009. Aventis has state-of-the-art manufacturing sites at Goa and Ankleshwar, where a number of pharmaceutical ingredients and formulations are produced. Both the sites comply with prevailing Good Manufacturing Practice (GMP) and Health, Safety and Environment (HSE) standards and score highly in terms of performance. The Ankleshwar plant achieved a record production of four billion tablets. New products were manufactured and launched in the domestic Tier 2 markets. The upgradation of the laboratory at Ankleshwar was completed and it was made operational. The company has 2106 employees as on December 31, 2009. 38 Dr Reddy’s Laboratories CEO GV Prasad Business Biopharmaceuticals Start-up Year 1984 Biotech Revenue Rs 62.5 crore Address 7-1-27, Ameerpet, Hyderabad – 500 016 Tel +91-40-23731946 Fax +91-40-23731955 Website  www.drreddys.com The total biotech revenue of Dr Reddy’s has grown to Rs 62.5 crore  in FY 2009-10 from Rs 40 crore in FY 2008-09. The company sells two biologic products—Grafeel (generic Filgrastim) and Reditux, (generic Rituximab), another eight products are in the pipeline. As a fully integrated pharmaceutical company, it runs three core businesses - pharmaceutical services and active ingredients, generics, and proprietary products, which includes new chemical entities (NCEs), differentiated formulations, and generic biopharmaceuticals. Dr Reddy’s conducts NCE research in the areas of metabolic disorders, cardiovascular indications, anti-infectives and inflammation. The company’s products are marketed globally, with a focus on India, US, Europe and Russia. It has eight FDA-inspected plants and three technology centers. ]]> <![CDATA[33-35-Themis Medicare-Venkateshwara Hatcheries-Vimta Labs]]> https://biospectrumindia.com/news/95/8093/33-35-themis-medicare-venkateshwara-hatcheries-vimta-labs.html https://biospectrumindia.com/news/95/8093/33-35-themis-medicare-venkateshwara-hatcheries-vimta-labs.html Tue, 15 Jun 2010 12:03:00 +0530 33 Themis Medicare CEO Dr Dinesh Patel Business Manufacturer and marketer of formulations and APIs of synthetic origin Start-up Year - Biotech Revenue Rs 90 crore Address 11/12, Udyog Nagar, SV Road, Goregaon (West), Mumbai-400 104 Tel +91-22-67607080 Fax +91-22-28746621 Website www.themismedicare.com Themis Medicare achieved  a total turnover of Rs 90 crore for the year ended March 31, 2010  as against Rs. 97.7 crores for the previous corresponding year. Themis Medicare is a joint venture pharmaceutical company, with Gedeon Richter Limited, Hungary. The company in over three decades, has made its presence felt in manufacturing and marketing of formulations and APIs of synthetic and biotech origin. Though their first breakthrough product was Vitamin B12, Themis moved on to manufacture synthetic APIs such as ethambutol hydrochloride, pyrithioxine derivatives, methylcobalamin, propofol and artemisinin derivatives. Themis Medicare made its presence felt in  the biotech market when in 2004 it merged with Artemis Biotech. Artemis Biotech is involved in biotechnology and fermentation activity. In the same year, Themis had obtained COS for lovastatin and simvastatin which enabled them to sell these statins in Europe. Lovastatin and Simvastatin today hold a significant share of exports of the company. 34 Venkateshwara Hatcheries Chair Person Anuradha Desai Business R&D, production and export of poultry and diagnostics Start-up Year 1986 Biotech Revenue Rs 90 crore Address Venkateshwara House, SN 114/A/2, Pune-Sinhagad Rd, Pune-411030 Tel +91-20-24251530 Fax +91-20-24251077 Website www.venkys.com Venkateshwara Hatcheries, a part of the Pune-based VH group, posted a revenue of Rs 90 crore for the financial year 2009-2010. As the first company to embark on a process of developing the industry on scientific lines, Venkateshwara Hatcheries occupies a special place in the Indian poultry scene. It pioneered the concept of parent franchisee operations, popularized cage farming, and introduced for the first time in India, the concept of inactivated vaccines and combination vaccines. The company has poultry operations in Maharashtra, Madhya Pradesh and the southern states of India. Included in its portfolio are new technology driven businesses like the egg powder plant in Hyderabad , a 100 percent export oriented unit, and wind energy farms on the outskirts of Coimbatore. The VH Group is entering Europe with a state-of-the-art poultry vaccine manufacturing facility in Bassecourt, Switzerland. According to B Venkateshwara Rao, Managing Director of the VH Group, if the approval process goes according to company’s plan, the Swiss facility will be operational by the end of 2011, and it will produce poultry vaccines for the European, Asian and other regulated markets. 35 Vimta Labs CEO Dr S P Vasireddi Business Contract research Start-up Year 1984 Biotech Revenue Rs 88.42 crore Address 142, IDA, Phase II, Cherlapally, Hyderabad - 500 051 Tel +91-40-2726 4141 Fax +91-40-2726 3657 Website  www.vimta.com Vimta Labs is one of India’s leading contract research and testing organization. Established in 1984 Vimta has an envious track record of serving several market leaders across the globe. The company reported biotech revenue of Rs 88.42 crore in 2009-20 as against Rs 81.60 crore in 2008-09 The company is a team of  756 professionals comprising 479 scientists in various disciplines such as chemistry, pharma, medicine, microbiology, molecular biology and informatics. The team is slated to double in next three years. The company is a multi-site organization with more than 300,000 sq ft world class laboratory facilities. The technologies deployed at Vimta are current and leading edge, duly validated. The company also provides full range of services to manage clinical studies from study design to  management to pre-approval and post-marketing service. ]]> <![CDATA[30-32-Ankur Seeds-Ajeet Seeds-Ecron Acunova]]> https://biospectrumindia.com/news/95/7790/30-32-ankur-seeds-ajeet-seeds-ecron-acunova.html https://biospectrumindia.com/news/95/7790/30-32-ankur-seeds-ajeet-seeds-ecron-acunova.html Tue, 15 Jun 2010 12:02:00 +0530 30 Ankur Seeds MD MG Shembekar Business Agri-business in field crops, vegetables & transgenic crops (Cotton) Start-up Year 1976 Biotech Revenue Rs 109.5 crore Address 27, New Cotton Market Layout, Nagpur- 440018 Tel +91-712-2726148; 2725117 Fax +91-712-2723455 Website www.ankurseeds.com The total revenue of Ankur Seeds for the fiscal year 2009-2010 is amounted to Rs 109.5 crore. The company initially started its research activities in cotton, okra, brinjal and chillies and today it has expanded its research area  to more than 15 crops. Cotton, paddy, okra, and solanaceous vegetables remain the major contributors to the company’s economy. Ankur has been a forerunner in marketing insect resistant cotton hybrids in the country. The company has also initiated research work on drought resistance cotton through transgenic approach. To comply with the requirements of R&D, the company is expanding its research laboratories with the  construction of 40, 000 sq ft additional lab space. The company has plans to invest Rs 5 crore in biotechnology in a phased manner for over three years to handle futuristic projects. Ankur has established its market brand in proprietary rice varieties and is in advance stages of developing disease resistant varieties for blast and blight through marker assisted breeding. 31 Ajeet Seeds CEO Sameer Mulay Business Research, production, processing and marketing of hybrid seeds Start-up Year 1986 Biotech Revenue Rs 103 crore Address Tapadia Terraces, 2nd Floor, Adalat Road, Aurangabad- 431 00 Tel +91-240-2333933 Fax +91-240- 2333335 Website www.ajeetseed.co.in Ajeet Seeds is a producer and processor of hybrid cottonseeds in India. During 2009-2010, the company totaled a sales figure of Rs 103 crore. It has received approval from GEAC for the sale of Bollgard-I (Ajeet-33 and Ajeet-155) and Bollgard-II (Ajeet-11) cotton hybrids in Central and South zone in 2006. It had also commissioned a modern bio-tech laboratory at Gangapur oin Aurangabad district. Understanding the pivotal role of biotechnology in seed industry, a separate department of biotechnology has been established in 2003. Its first vegetable, Ajeet-311, hybrid bhendi, was launched in 2002. It was subsequently followed by hybrid chillies, brinjal, tomato, bottle gourd and bitter gourd. Ajeet seed is the first private seed company to introduce proprietor variety of wheat, Ajeet-102. The product profile of the company covers 22 crops and their 55 different hybrids varieties. The company was bestowed the DSIR National Award, 2006 for Outstanding Research Achievements  by the Government of India, Ministry of Science and Technology, New Delhi. 32 Ecron Acunova MD D A Prasanna Business Clinical research organization Start-up Year 2005 Biotech Revenue Rs 97 crore Address Mobius Towers, SJR i-Park, EPIP, Whitefield, Bangalore-560066 Tel +91-80-66915700 Fax +91-80-66915719 Website  www.ecronacunova.com Bangalore based CRO Ecron Acunova reported turnover of Rs 97 crore for the fiscal year 2009-10. The company has established a reputation for quality clinical research in phase II-IV in India. With the early mentoring it got from leading Indian pharma like Cipla and Matrix and globally leading companies in imaging agents, it quickly established a strong reputation for quality services. Investment made in PK/PD, central lab and DM services enabled the company to have control over its services from study start to final report, resulting in a reliable service. The company acquired the German CRO in 2007. This gave access to Western and Eastern Europe, enabling rapid growth in revenues. In 2009, the company has announced a partnership with Japanese company Tokyo CRO. Ecron Acunova serves eight out of the top 20 Pharma companies in the world. The company is also  managing some of the DBT funded trials as well as NCE of leading Indian Pharma. ]]> <![CDATA[21-23-Zydus Cadila-Lambda Therapeutic]]> https://biospectrumindia.com/news/95/6445/21-23-zydus-cadila-lambda-therapeutic.html https://biospectrumindia.com/news/95/6445/21-23-zydus-cadila-lambda-therapeutic.html Tue, 15 Jun 2010 11:56:00 +0530 21 Zydus Cadila (Formerly Cadila Healthcare) CEO Pankaj R Patel Business Biopharmaceuticals Start-up Year 1995 Biotech Revenue Rs 147.48 crore Address Zydus Tower, Satellite Cross Roads, Ahmedabad – 380015 Tel +91-79-26868100 Fax +91-79-26862365 Website www.zyduscadila.com Zydus Cadila discovers, develops, manufactures and markets a broad range of healthcare products. The company has posted a revenue of Rs 221.22 crore for the fiscal year 2009-2010. The group’s operations range from API to formulations, animal health products and cosmeceuticals. Headquartered in Ahmedabad, the group’s operations spread across the US, Europe, Japan, Brazil, South Africa and 25 other emerging markets. Under the purview of biotechnology research it looks at development of biogeneric therapeutic proteins, antibodies, vaccines, search for novel targets  and validation of targets.  The company was in news last year when it received an approval from the Drug Controller General of India (DCGI) to market the H1N1 (swine flu) vaccine. The egg based, inactivated vaccine based on conventional technology has been developed by  the group’s researchers at its Vaccine Technology Centre (VTC) in Ahmedabad. VTC further plans to develop a wide spectrum of vaccines against bacterial, viral and protozoal infections. The group also markets anti-rabies and typhoid vaccines. The Zydus Research Centre (ZRC) is the dedicated research and development arm of Zydus Cadila, established in the year 2000. 22 Lambda Therapeutic Research Director Ashish Kumar Dasgupta Business Clinical trials implementation, laboratory and data management and bio analysis Start-up Year 1999 Biotech Revenue Rs 145 crore Address Near Gujarat High Court, SG Highway, Gota, Ahmedabad 380061, Gujarat Tel +91-79-40202020 Fax +91-79-40202021 Website www.lambda-cro.com Lambda Therapeutic Research operates as a contract research organization to deliver clinical development solutions. It’s revenue for the last fiscal year amounted to Rs 145 crore. The company’s services include clinical trials implementation, laboratory and data management, information technology support, medical affairs assistance, quality assurance, and bio analysis. In addition, it conducts pharmacokinetic, bioequivalence, first-in-human and biostatistics study programs. Lambda also provides therapeutic services for dermatology, oncology, rheumatology, cardiovascular, central nervous system and autoimmune deficiencies. Ahmedabad-headquartered  Lambda Therapeutic has additional facilities in Mumbai and Erwitte, Germany. In an inspection conducted by Department of Medical Sciences, Ministry of Public Health, Thailand, in October 2008 at Ahmedabad, the company’s Bioanalytical facility was approved by Ministry of Public Health, Thailand for GLP. Also, in 2008, Lambda received the ANVISA approval  for  its Ahmedabad facility. 23 Krishidhan Seeds MD Sushil Karwa Business Production and distribution of hybrid seeds Start-up Year 1996 Biotech Revenue Rs 133.23 crore Address Krishidhan Bhavan, D3 - D6, Additional MIDC Area, Aurangabad Road, Jalna, Maharashtra Tel +91-2482-222750 Fax +91-2482-222600 Website www.krishidhanseeds.com Krishidhan Seeds clocked biotech revenues of Rs 133.23 crore for the fiscal year. The company develops, produces and distributes proprietary hybrid seeds and selections to Indian farmers. The company has experienced significant sales growth of six times over the last five years. It has reported consolidated revenues of Rs 279 crores (approximately $88 million) for the current financial year. Krishidhan Seeds has a pan-India presence and offers a diversified portfolio of more than 120 products including field crops, vegetable seeds and crop nutrition. The company’s workforce is 885 people strong. Out of this, 32 are PhDs and 171 are post graduates. The expanse of its activities is across the length and breadth of India. This has resulted in establishment of strong trust and brand equity of Krishidhan among all its stakeholders. The group so far has invested heavily in R&D infrastructure to set up 10 regional research stations across  India, and a state-of-the-art biotech facility in its Technology Centre at Jalna. ]]> <![CDATA[A fast clip growth for BioAgri]]> https://biospectrumindia.com/news/95/7213/a-fast-clip-growth-for-bioagri.html https://biospectrumindia.com/news/95/7213/a-fast-clip-growth-for-bioagri.html Mon, 14 Jun 2010 15:48:00 +0530 A fast clip growth for BioAgri â€¢ Agri biotech grew at 37% in FY 2009-10 â€¢ There are over 30 companies marketing Bt cotton seeds in India â€¢ The segment will grow at an average of 26% in the next 5 years Agri biotech is the third largest contributor to Indian biotech industry in FY 2009-2010 with a total segment turnover of Rs 1,936 crore, accounting for almost 14 percent of the total biotech revenues. Registering a growth of 37 percent over last year, BioAgri emerged the industry's fastest growing segment. The fact that BioServices segment dominated by exports faced minor setbacks on account of currency fluctuations helped BioAgri gain lead. In FY 2008-09 BioServices with a growth of 31 percent was the fastest growing industry segment. India is the fourth largest country in the world with almost 8.4 million hectares of area under Bt cotton. On one side the area under Bt cotton has been on increasing, on the other side the prices for Bt seeds packets has been slightly on decline. This decline is because of government's intervention and more companies launching different technologies for producing Bt seeds. The number of companies selling Bt cotton seeds in India has increased dramatically over the last eight years since the first commercialization in 2002. Today, there are over 30 companies marketing Bt cotton seeds in the country. Nuziveedu Seeds is the largest seller of Bt cotton seeds. The company sold 70 lakh packets generating Rs 476.86 crore in revenues. Rasi Seeds is the second largest contributor with Rs 358.78 crore in sales. Nuziveedu has 25 percent of the market share while Rasi Seeds is close second with 19 percent market share. Other significant players include Ajeet Seeds, Ankur Seeds selling 12-20 lakh packets each in FY 2009-10. Region Production North 600 kg per hectare West 516 kg per hectare Central 472 kg per hectare South 595 kg per hectare A total of 280 lakh packets of seeds containing 450 grams were sold in 2009, approximately 87 percent being Bollgard II and 13 percent bollgard I. An additional 20 lakh packets of spurious seeds were estimated to have been sold illegally to the farmers mainly in Gujarat state. While in most of the regions, the Bollgard I and Bollgard II cotton seeds were priced at Rs 650 and Rs 750 respectively. In North (mainly Punjab, Haryana and Rajasthan), the pricing was kept at Rs 759 for Bollgard I and Rs 925 for Bollgard II. The â€œBollgardâ€? Bt cotton seeds were sold in nine states-Andhra Pradesh, Tamil Nadu, Karnataka, Gujarat, Madhya Pradesh, Maharashtra, Haryana, Punjab, and Rajasthan. Maharashtra leads as the largest selling state with almost 90 lakh packets sold in the region followed by the South (75 lakh packets) and North (45 lakh packets). The northern market is mainly held by Shriram Bioseeds. A region wise split shows that the Northern region of India recorded maximum production of Bt cotton. An important event of 2009 was the approval of MLS 9124, developed indigenously by Metahelix Life Sciences. The product has a synthetic cry 1C gene. The other development was the release of two cotton hybrids namely MH 5124 and MH 5174 expressing the synthetic cry 1C gene (MLS 9124).  Notes: *Monsanto royalty has not been taken into account as segment revenue Top 10 Agri Companies by Revenue (2009-10) Rank 2010 Company 2009-10 (Revenue in Rs Cr) 2008-09 (Revenue in Rs Cr) % Change Over 2008-09 1 Nuziveedu Seeds 476.86 449.58 6.07 2 Rasi Seeds 358.78 375.59 -4.48 3 Mahyco 312 211.12 47.78 4 Monsanto* 255 345.00 -26.09 5 Krishidhan Seeds 133.23 63.25 110.64 6 Ankur Seeds 109.5 80.35 36.28 7 Ajeet Seeds* 103 - - 8 Nath Seeds 85 48.50 75.26 9 JK Agrigenetics* 35 26.00 34.62 10 Bayer CropScience* 22.5 - - * BioSpectrum estimates All figures in Rs. Crore unless indicated otherwise BioIndustrial to grow over 15% for next 5 years â€¢ BioIndustrial grew 16% in FY 2009-10 â€¢ 70% of the industrial enzyme domestic demand is imported The BioIndustrial market mainly comprising industrial enzymes is estimated to be Rs 564 crore in the year 2009-10 as against Rs 478 crore in 2008-09. The segment grew 16 percent in FY 2009-10. Though the overall enzyme consumption figures of India are comparatively low with respect to other countries and 60-70 percent of domestic demand is imported, the segment on an average has been growing over 15 percent in the last five years. In India, the industrial enzyme consumption is predominantly in the detergents market (40 percent), followed by the starch market (25 percent) . The other important segments are food and feed, textiles, leather, pulp and paper. In recent years, enzymes have found numerous applications in the food, pharmaceutical, diagnostic and chemical processing industries. The trend for their application in almost every sector is on increase. The leading players in this segment include Novozymes which has over 50 percent market share followed by Advanced Enzyme Technologies holding 25-30 percent market share. Other important players are Maps, Genecor, Lumis and Kerry Biosciences. Besides, a new entrant Anthem Cellutions, a part of Anthem Biosciences group has gained significant market share over a short period of time. Apart from focusing on the local market, companies like Advanced Enzyme Technologies are looking at other markets such as China. Considering the potential opportunity in the other markets Advanced Enzyme has registered good growth in its export sales. The Indian companies are reporting a good growth, a lot of R&D is happening in these companies and new applications are being explored. Indian companies are looking at technologies from Europe, China and Australia. However, with respect to global enzyme industry India still needs to do a lot of catching up. Top 3 BioIndustrial Companies by Revenue (2009-10) Rank 2010 Company 2009-10 (Revenue in Rs Cr) 2008-09 (Revenue in Rs Cr) % Change Over 2008-09 1 Novozymes South Asia* 268 250.00 7.2 2 Advanced Enzymes 121 88.60 36.57 *BioSpectrum estimates All figures in Rs. Crore unless indicated otherwise BioInformatics grows at sluggish pace â€¢ Segment grows at 5% â€¢ Domestic market contributes 68% of BioInformatics revenue The smallest segment of the Industry, BioInformatics which has just about 2 percent segment share in the overall industry, has been sluggish in FY 2009-10. It registered a 5 percent growth over 2008-09, clocking Rs 231 crore in revenues last year as compared to Rs 220 crore in FY 2008-09, when it recorded a growth of 16 percent. The pure-play BioInformatics companies in India include Strand Genomics, Ocimum Biosolutions, SysArris, CytoGenomics and Molecular Connections. These companies have come out with products that cater mainly to the needs of the pharmaceutical and biotechnology companies. Most of these companies are small and medium enterprises based at locations such as Bangalore, Hyderabad, Pune. Top 3 BioInformatics Companies by Revenue (2009-10) Rank 2010 Company 2009-10 (Revenue in Rs Cr) 2008-09 (Revenue in Rs Cr) % Change Over 2008-09 1 Ocimum Biosolutions 41.4 47.57 -12.97 2 Strand Life Sciences 35 35.00 0 *All figures in Rs. Crore unless indicated otherwise ]]> <![CDATA[CROs take the growth highway]]> https://biospectrumindia.com/news/95/1644/cros-take-the-growth-highway.html https://biospectrumindia.com/news/95/1644/cros-take-the-growth-highway.html Mon, 14 Jun 2010 15:40:00 +0530 CROs take the growth highway â€¢ BioServices registers 28% growth with revenue of Rs 2,639 crore â€¢ Top 10 CROs make up 60% of the total segment revenue BioServices segment registered a growth of 28 percent in 2009-10 over last year's total segment revenue of Rs 2,062 crore. The 3 percent drop in growth from a 31 percent of 2008-09 was primarily due the currency fluctuations in FY 2009-10. Exports continue to dominate this segment accounting for over 90 percent of the total revenues. In this segment, accounting for 19 percent of overall revenue, companies such as Lambda Therapeutic Research, MaxNeeman and Anthem Biosciences have done exceedingly well in FY 2009-10 with Lambda and MaxNeeman growing well over 100 percent and Anthem Biosciences at over 60 percent. The Top 10 CROs make up 60 percent of the total segment revenue of Rs 2,639 crore. In the last three-to-five years, many companies have set up contract research and clinical research services operations in India. Considering the potential opportunity and fast clip market growth, the number of companies in this segment will continue to grow faster than the industry average in the next two years as well. The segment is growing on account of the growing requirements of the multinational companies that are looking at India as an outsourcing destination with high-skill, low cost advantage. Besides, due to business model evolutions driven by market forces, even the domestic companies are outsourcing various portions of the drug discovery chain. However, the competition in the segment is growing to be intense impacting bottomlines adversely. The fact that all new companies are now born global is adding to this competition. SIRO Clinpharm having presence in India, Western & Central Eastern Europe, and US has now entered into an alliance with DreamCIS Inc., a leading CRO based out of Seoul in South Korea. The company has also signed an agreement with Virginia Contract Research Organization (VCRO), a Taiwan-based CRO to offer a range of services to Taiwan companies. And, it is not just Asia Pacific market that the company is looking at. SIRO is expanding operations in the developed markets like USA and Europe as well. It has entered an alliance with Advanced Clinical Trial Solutions (ACT Solutions), Flemington, NJ, USA. Syngene International, a subsidiary of Biocon Group, has partnered with Sapient Discovery, a US-based biotechnology company. Both the companies intend to provide a highly integrated platform for structure-based drug discovery. It also signed a pact with another US company, Endo Pharma, to jointly discover and develop novel biological drug molecules to fight cancer. Bangalore-based Ecron Acunova has tied-up with a Japanese CRO and expects this alliance to trigger a trend and set off 40-50 clinical trials between India and Japan in the next two-to-three years. Japan is the second biggest pharma market after the US. This apart, the Indo-German clinical research major with its established presence in India and Europe is scouting for more market share in clinical research in these countries and other parts of the globe. Veeda Clinical Research, which has completed five years of existence in January 2010, has opened its office in South East Asia by signing a collaborative agreement with the Malaysian Ministry Health to open a Phase I and Early Clinical Development Unit in the Ampang Hospital in Kuala Lumpur. India services industry is, decidedly, set to take the collaboration growth highway. Rank 2010 Company 2009-10 (Revenue in Rs Cr) 2008-09 (Revenue in Rs Cr) % Change Over 2008-09 1 Quintiles India* 375 --- --- 2 Syngene International 252 224.60 12.2 3 Jubilant Organosys 249.3 242.00 3.02 4 Siro Clinpharm 150 280.00 -46.43 5 Lambda Therapeutic research* 145 30.00 383.33 6 Veeda Clinpharm 110 --- --- 7 Ecron Acunova 97 8 Vimta Labs 88.42 81.60 8.36 9 Anthem Biosciences 53 32.34 63.88 10 Max Neeman International 40 15.00 166.67 * BioSpectrum estimates All figures in Rs. Crore unless indicated otherwise ]]> <![CDATA[BioPharma to grow over 10% for next 5 years]]> https://biospectrumindia.com/news/95/4577/biopharma-to-grow-over-10-for-next-5-years.html https://biospectrumindia.com/news/95/4577/biopharma-to-grow-over-10-for-next-5-years.html Mon, 14 Jun 2010 15:32:00 +0530 BioPharma to grow over 10% for next 5 years â€¢ BioPharma clocks Rs 8,829 crore in revenues â€¢ It accounted for 62% of the total revenue and grew by 12% over FY 2008-09 â€¢ The Top 20 BioPharma companies contributed close to Rs 6000 crore The Indian BioPharma market comprising primarily of vaccines, therapeutic drugs, insulin, animal biologicals, statins and diagnostics in 2009-2010, continued to grab the largest share of the total biotech industry revenues of over Rs 14,199 crore. It contributed Rs 8,829 crore, accounting for 62 percent market share. Vaccines had the largest pie with an estimated sales of Rs 2,180 crore over last year's figure of Rs 2,000 crore. The vaccine segment-human as well as animal vaccines-accounted for 50-60 percent of the total BioPharma market. Total estimated sales from the human vaccine business stood at Rs 1,750 crore over the 2008-2009 figure of Rs 1,550 crore. Domestic sales of human vaccines just about crossed Rs 1,000 crore. In FY 2008-09 this figure stood at Rs 900 crore. Export sales is estimated to have generated Rs 750 crore, as compared to Rs 650 crore in FY 2008-09. Animal Vaccines registered a marginal decline with sales of Rs 430 crore over last year's figure of Rs 450 crore. In animal vaccines, poultry vaccines clocked Rs 220 crore, cattle and sheep vaccines registered Rs 210 crore. The vaccine market will continue to drive the growth of the biopharma segment growing in the range of 10-13 percent in the next 5 years. The factors that will drive this include education and awareness about disease prevention, increase in disposable income and participation by government. The market will clearly shift to combination vaccines such as Pentavalent vaccines. Domestic players such as Bharat Biotech and Shantha Biotech have already received massive orders from the Government of India for immunization programmes in Himachal Pradesh, Kerala, Tamil Nadu, Jammu and Kashmir and Karnataka. There is going to be a change from largely whole-cell pertusis -based combos to acellular-based combos in the coming years. Newer vaccines like Pneumo conj, Meninge Conj and HPV would drive the market growth in paediatric and adolescent segment, while Flu will continue to be a big driver in the adult market segment. A noteworthy product launched during 2009-2010 was Shantha's Shanchol-India's first oral vaccine to protect against cholera. Shanchol is a bivalent inactivated-whole-cell oral cholera vaccine developed by Shantha in collaboration with the International Vaccine Institute (IVI), Seoul, Korea. Driven by a rise in chronic diseases and investments in the healthcare infrastructure, diagnostics and therapeutics business also had a positive impact on the industry. The diagnostic market is estimated to be at Rs 2,000 crore with molecular diagnostic market share at $300 million in FY 2009-2010. This accounts for 20-22 percent share of the total BioPharma market. A highly competitive segment, the market currently is growing at 15-20 percent with a 50:50 revenue share split between MNCs and homegrown companies. Major MNC companies in the diagnostic market include Roche, Siemens (which has acquired Bayer Diagnostics) and Abbott while homegrown names in the top league include Tulip Group, Transasia Biomedicals, RFCL (Diagnova), Span Diagnostics and Trivitron. This growth is driven from the gradual acceptance of the concept of preventive and personalized medicine. The therapeutics market claimed 15 percent of market share in FY 2009-2010 with the cancer therapeutics sales clocking Rs 311 crore. Companies in the segment are now moving towards novel targeted therapies and supportive care products. Cancer therapeutics is a lucrative business for many Indian companies because of high unmet needs, high prices of innovator drugs, increase of awareness and affordability. These homegrown players will play a pivotal role in reducing the price points of important cancer drugs. The market size of Oral Diabetes Drugs is estimated to be Rs 1,550 crore and market size of Insulin (including analogs) is approximately Rs 612 crore. The large market size is reflective of India emerging as the diabetes capital of the world. Between 1995 and 2005 the number of diabetic patients doubled from 20 million to 40 million and this is projected to grow to 70 million patients by 2025. In Insulin (including Analog) segment, Novo Nordisk is the market leader with over 50 percent market share while Eli Lilly has 22 percent market share. Analogs which currently contribute 27 percent in value (8 percent in volume) are the fastest growing segment (with 2007-09 CAGR of 32 percent) in value. Within insulin market, novel delivery devices would be the growth drivers in the coming years. Biogenerics segment in the near term will be a key growth driver for Indian players especially with the US set to establish a biogenerics (biosimilars) pathway by 2013. In India, Erythropoietin (EPO) clocked a sales of Rs 10 lakh ($22,000), c-GSF-Rs 5 lakh ($11000), interferonâ€“Rs 10 lakh $22000 and streptokinase Rs 7 lakh ($16000). These products are been sold at price discounts of upto almost 85 percent of its innovator drug thus making them affordable to the masses. Currently, Dr Reddy's Labs, Ranbaxy, Biocon, Shantha Biotechnics and Intas Biopharmaceuticals are actively involved in the space. There are around 25 Indian players with over 50 products already being sold in the Indian market and some being sold in the unregulated markets as well. Other prominent companies that have started initiatives in the field include Glenmark, Cipla and Lupin Pharma. Last year, Cipla entered into a 50:50 joint venture (JV) with a Chinese company for biosimilars. The JV would be called Biomab and Cipla is likely to bring out Biomab's first product later this year. Top 20 BioPharma Companies by Revenue (2009-10) Revenue Rank 2010 Company 2009-10 (Revenue in Rs Cr) 2008-09 (Revenue in Rs Cr) % Change Over 2008-09 1 Biocon 1180 912.34 29.34 2 Serum Institute of India* 850 1114.00 -23.7 3 Panacea Biotec 703.19 597.14 17.76 4 Reliance Life Sciences* 450 - - 5 NovoNordisk* 342 330.00 3.64 6 Shantha Biotech 334.23 247.00 35.32 7 Indian Immunologicals 272.87 231.46 17.89 8 Bharat Biotech 271.66 241.05 12.7 9 Eli Lilly 187 164.00 13.85 10 Bharat Serums 175 140.00 25 11 Haffkine Biopharma 168.98 - - 12 Cadila Healthcare 147.48 93.70 57.4 13 GlaxoSmithKline 123.34 83.48 47.75 14 Intervet India 121.6 - - 15 Intas Biopharma 115 89.27 28.82 16 Themis Medicare 112.12 97.50 14.99 17 Concord Biotech 111.7 52.13 114.27 18 Venkateshwara Hatcheries* 90 - - 19 Aventis Pharma 68.34 36.00 89.83 20 Dr Reddy's Laboratories 62.5 40.00 56.25 * BioSpectrum estimates All figures in Rs. Crore unless indicated otherwise ]]> <![CDATA[West retains No 1 position]]> https://biospectrumindia.com/news/95/2523/west-retains-no-1-position.html https://biospectrumindia.com/news/95/2523/west-retains-no-1-position.html Mon, 14 Jun 2010 15:01:00 +0530 Western cluster continues to dominate India's biotech industry with 46 percent share in the overall revenues of Rs 14,199 crore. The 137 companies in the region between themselves clocked Rs 6,631 crore in FY 2009-10 increasing the region's share in the overall revenues by 3 percent over FY 2008-09, thus gaining a lead of 6 percent over South, its close competitor for the top slot. Not just that, this year, Mumbai outpaced Bangalore to become India's Top Biotech City with a small margin of about Rs 200 crore in terms of revenue. Besides, Gujarat's share in the total revenue has grown by almost 50 percent as compared to its revenues of Rs 755 crore in 2008-09. In Maharashtra , Pune's contribution went down as the leading company of the region Serum Institute of India suffered contract set backs. So, has South region's position vis-a-via West worsened since last year? Not really. Given the policy and infrastructure push the situation next year could even see a dramatic shift. South continues to remain India's largest Biotech cluster in terms of the number of companies. In 2009-10, it added another 9 companies-highest in the country. The region has 172 biotech companies (West has 137 companies), which churned out Rs 5537.68 crore in revenues in FY 2009-10 making up 39 percent of the overall revenues. In the South region, Karnataka state government has proposed to set up five new biotech parks and has invested Rs 1,100 crore towards new initiatives in 2009-10. Another biotech hub Andhra Pradesh is also setting up a MedTech Valley, a world-class cluster for manufacturing medical devices and equipment near Genome Valley at Shameerpet in Hyderabad. The state government will provide 1,200 acres of land for the project. The project will be executed via a public-private partnership model. Kerala has also taken steps to jump on the biotech bandwagon. Kerala State Industrial Development Corp (KSIDC) has announced that it will set up a state-of-the-art life science park at Thiruvananthapuram at an estimated cost of Rs 300 crore. The project that will come up in 260 acres at Thonnakkal, would be developed under public-private partnership model. The park will house an incubation center, a technology development center, biotechnology companies, drug discovery companies, pure play firms and also contract research outsourcing units. Looking ahead, year 2010-15 will see some shifts, specializations and emergence of clear patterns. During this period many of the mega initiatives are likely to take off and have the potential to be a â€œleap of sortsâ€? that can build a virtuous cycle for the region. NCR at No 4 The Northern biocluster â€“ National Capital Region (NCR) has the Top 3 companies contributing 56 percent of the revenues and about 15 percent of the overall industry revenue. This cluster is better known for its research institutes and of course, government bodies. More recently, the development of 200 acre Health Biotech Science Cluster (HBSC) at Faridabad is underway. A multidisciplinary approach to education and research, this Biotech cluster would comprise Translational Health Science & Technology Institute (THSTI), Regional Center for Biotechnology (RCB) Center for Vaccinology, Molecular Medicine Center, Center for Diagnostics, Biotech Park,), Center for Health Science Technology, Center for Platform Technologies, UNESCO Center, Incubator and a Center for Animal Model for Clinical Advances. As a first step, a temporary THSTI lab was recently inaugurated at Gurgaon. This would be shifted to the main site at Faridabad in two-three years after the infrastructure is ready. Besides, there is the biotech park at Lucknow offering a very good platform for the small and medium biotech companies to do research, collaborate and expand their business. The Biotech Parks at three locations -Sitapura-Jaipur and Chopanki, Bhiwadi (Alwar), and Borandi, Rajasthan have been initiated by Rajasthan State industrial Development & Investment Corporation (RIICO). Then, there is the proposed biocluster at Mohali (Punjab), upcoming biotech park at Chandigarh (Punjab) and another one at Nalagarh in Himachal Pradesh- all this is expected to provide the much needed boost to the biotech companies in the North region. Biotech Revenue Cluster Trend (2002-10) â€¢ Top 10 companies in the West have 43% share in the region. â€¢ Serum Institute of India (Rs 850 crore), the region's No 1 company makes up for about 13% of the region's revenue and contributes 6% to the overall industry revenue. â€¢ West is also base for top bioagri companies such as Monsanto, Mahyco and Ajeet Seeds. â€¢ MNCs like GlaxoSmithKline, Roche, Aventis Pharma, Wyeth, Quintiles are also headquartered in the region. â€¢ Four of India's top 10 services companies (CROs) are also based out of West, including the No 1 CRO in the Indian industry â€“ Quintiles India (Rs 375 crore) Top Companies in West Company 2009-2010 (Revenue in Rs Cr) % Share in Region % Share of Total Biotech Serum Institute of India* 850 12.82 5.99 Reliance Life Sciences* 450 6.79 3.17 Quintiles* 375 5.66 2.64 Mahyco 312 4.71 2.20 Monsanto* 255 3.85 1.8 Bharat Serums 175 2.64 1.23 Haffkine Biopharma 168.98 2.55 1.19 Siro Clinpharm 150 2.26 1.06 Cadila Healthcare 147.48 2.22 1.04 Lambda Therapeutic Research* 145 2.19 1.02 Ajeet Seeds* 103 1.55 0.73 Top 10 West 2883.46 43.48 20.31 Total West 6631.01 46.70 Top Companies in South Company 2009-2010 (Revenue in Rs Cr) % Share in Region % Share of Total Biotech Biocon 1180 21.31 8.31 Nuziveedu Seeds 476.86 8.61 3.36 Rasi Seeds 358.78 6.48 2.53 NovoNordisk* 342 6.18 2.41 Shantha Biotech 334.23 6.04 2.35 Indian Immunologicals 272.87 4.93 1.92 Bharat Biotech 271.66 4.91 1.91 Novozymes South Asia 268 4.84 1.89 Syngene International 252 4.55 1.77 Ecron Acunova 97 1.75 0.68 Top 10 South 3853.40 69.59 27.14 Total South 5537.68 39.00 Top Companies in North Company 2009-2010 (Revenue in Rs Cr) % Share in Region % Share of Total Biotech Panacea Biotec 703.19 34.63 4.95 Jubilant Organosys 249.30 12.28 1.76 Eli Lilly 186.72 9.20 1.32 Top 3 North 1139.21 56.11 8.02 Total North 2030.48 14.30 *BioSpectrum estimates All figures in Rs. Crore unless indicated otherwise ]]> <![CDATA[SIRO Clinpharm in expansion mode]]> https://biospectrumindia.com/news/95/7260/siro-clinpharm-in-expansion-mode.html https://biospectrumindia.com/news/95/7260/siro-clinpharm-in-expansion-mode.html Mon, 14 Jun 2010 14:55:00 +0530 20SIRO Clinpharm Head:Dr Gautam Daftary (MD) Business:Clincial trials services from phase-I to phase-IV Startup Year:1996 Address:DIL Premises, Ground floor, Swami Vivekanand Road, Near Tatwagyan Vidyapeeth, Thane-400607, Maharashtra Tel:+91-22-25848000 Fax:+91-22-25848475 Website:www.siroclinpharm.com SIRO Clinpharm Private Limited (SIRO), the first CRO in India to start operations in 1996, offers full scope services, conducting clinical trials in the pharmaceutical, biotechnology and medical devices sectors in compliance with international standards. It has offices in India and the US and a recently set up base in Europe. Till date, SIRO has conducted over 130 clinical trials, recruiting over 20,000 clinical trial subjects, serving 9 out of the Top 10 global pharma and biotech companies as well as mid-size companies, passed over 240 audits by sponsor QA teams and working on USFDA, EMEA, UK MHRA, Korean FDA WHO Health Canada, & DCGI submissions. The 12-year-old CRO, which today has presence across 17 countries, had for a long time been looking at newer geographies apart from the usual matured markets which is why last year, it went on a 'go global missionâ€? wherein, it entered the East European market and other non-traditional countries-all of which provide the same advantages as India namely, trained and skilled expertise and trials at a much lower cost. â€œThe company has chalked out major plans for North America and South East Asia to achieve a turnover of Rs 500 crore in the coming months. SIRO Clinpharm's investors [Kotak Private Equity, 3i and Daftarys (founders)] will go in for an exit strategy through an IPO route by 2011,â€? said Dr Chetan Tamhankar, CEO, SIRO Clinpharm. SIRO Clinpharm having presence in India, Western & Central Eastern Europe, and US now entered into alliance with DreamCIS Inc. a leading CRO from South Korea. This will help SIRO to build a strong competitive advantage in entire Asia Pacific region, while on the other hand it will create a sustainable value for its existing as well as potential customers. Similarly, it also signed alliance with Virginia Contract Research Organization, a Taiwan-based CRO to offer a range of services to Taiwan companies. Not just Asia Pacific market SIRO also looked at expanding its operations in the developed market like USA and Europre. In that direction it has signed alliance with Advanced Clinical Trial Solutions LLC (ACT Solutions), Flemington, NJ, USA. This will help SIRO to expand its Oncology Clinical development and patient recruitment expertise to North America. Having presence in Europe with the acquisition of Omega Mediation, a Germany-based CRO in April 2008, in 2009 SIRO opened its office in Prague, Czech Republic to further strengthen its operational capabilities in Europe. Dr Tamhankar said, â€œWe have major expansion plans in the coming months. In the next 12-18 months we want to tap key geographies like North America and Eastern Europe. In addition to this we would like to expand our service offerings. To fulfill these purposes we have to opt for IPO.â€? ]]> <![CDATA[Consistent performer]]> https://biospectrumindia.com/news/95/3334/consistent-performer.html https://biospectrumindia.com/news/95/3334/consistent-performer.html Mon, 14 Jun 2010 14:53:00 +0530 19HaffkineBio-Pharma Head:P R Sabde (MD) Business:Production and supply of biopharmaceutical products to state agencies/government organizations Startup Year:1975 Address:Acharya Donde Marg, Parel, Mumbai - 400012 Tel:+91-22-24129320 Fax:+91-22-24168578 Website:www.vaccinehaffkine.org Haffkine Bio-Pharmaceutical Corporation (HBPCL), a fully-owned Government of Maharashtra has been engaged in the manufacture and supply of wide range of biological and non-biological products comprising bacterial and viral vaccines, antisera, toxoids injectables. It clocked an annual sales revenue of Rs 168.98 crore for the year 2009. Haffkine Bio-Pharma has witnessed a consistent growth in last five years. Haffkine Bio-Pharma has been contributing significantly by supplying Oral Polio Vaccine to UNICEF and Government of India. Similarly, it ensures timely and adequate supply of its products at a reasonable price to all the health institutions/hospitals of Govt. of Maharashtra. The company successfully obtained UN pre-qualification for Monovalent Oral Polio Vaccine Type1 in 2007 and since then there has been no look back for Haffkine Bio-Pharma. Recently it exported tOral Polio Vaccine (tOPV) to Yemen. Haffkine Bio-Pharma, which has a capacity to manufacture 60 crore doses of OPV per year, achieved a sustained growth by entering into business alliances aimed at the manufacture of new vaccines of social relevance. In keeping with the corporate philosophy of continuous improvement the company has taken up modernization and up-gradation of pharmaceutical manufacturing facility at Parel. Similar up-gradation and modernization of Antisera facility at Pimpri is under progress which will be commissioned during this year. Haffkine Bio-Pharma is also planning to undertake building new manufacturing facilities complying with WHO GMP standards for DTP/ Pentavalent Vaccine and the possibilities are being explored for technology transfer for pentavalent vaccine. Considering these modernization and up-gradation and expansion plans, it is poised for a bright outlook in areas like vaccines, antisera and pharmaceuticals. Haffkine has a farm and laboratory at Pimpri near Pune where antitoxins and sera for snake and scorpion venom, tetanus and diphtheria toxins are produced. It also formulates pharmaceutical products, disinfectants, ointments, injectables, syrups and mixtures at its unit at Mumbai. It has a well-equipped animal house in Mumbai for breeding laboratory animals. When HINI influenza virus started creating problems by spreading across the world in 2009, the scientists at the Haffkine Institute which was earlier part of Haffkine Bio-Pharma discovered an ominous new flu virus, sparking-off fears of a catastrophic global outbreak. Haffkine Institute doubled its novel H1N1 influenza (swine flu) testing capacity by procuring new equipment. At present, it has the capacity to test approximately 80 samples per day. This apart specific initiatives have been taken for meeting the demand for the life saving drugs in other states, as well as in other countries. ]]> <![CDATA[Back on growth track]]> https://biospectrumindia.com/news/95/1612/back-on-growth-track.html https://biospectrumindia.com/news/95/1612/back-on-growth-track.html Mon, 14 Jun 2010 14:42:00 +0530 18Bharat Serums Head:Dr Bharat Daftary (CMD) Business:R&D, manufacturing and marketing of biological, pharmaceutical and biotechnology products Startup Year:1971 Address:Hoechst House, 16th Floor, Nariman Point, Mumbai-400021, Maharashtra Tel:+91-22-66560900 Fax:+91-22-66560901 Website:www.bharatserums.com Fiscal 2009-10 saw Bharat Serums and Vaccines (BSV) registering a growth of 25 per cent clocking a total sales turnover of Rs 175 crore as against Rs 140 crore in fiscal 2008-09. The BSV registered a good growth as against the industry growth of 16 percent in 2009. BSV has received funding from the Malaysian firm OrbiMed to fecilitate the next stage of growth. â€œInvestment in BSV by one of the largest healthcare focused funds validates our company's research, manufacturing and marketing capabilities and distinctive business model. OrbiMed's investment and involvement will considerably facilitate the next stage of BSV's growth,â€? stated Bharat Daftary, chairman and managing director of BSV. â€œBSV continues to be at the forefront of proprietary research of value added therapeutics and the investment by a knowledgeable investor like OrbiMed acts a booster for our self belief, long term value generation and growth prospects,â€? Dr Daftary added. The company manufactures and markets biological, pharmaceutical and biotechnology products and has in its portfolio over 25 brands which includes Plasma Derivatives, Monoclonals, Equine Antitoxins And Serums, Cardiovascular, Antimicrobials, Antifungals, Anesthetics, Hormones. Over the years, BSV has put in emphasis on its R&D operations both in India and overseas. It has three distinct R&D divisions working extensively on NDDS, biotechnology and equine products. In April 2010, Piramal Healthcare Limited, acquired BSV's injectible anesthetic products business. The former signed a definitive agreement to acquire the Pune-based Bharat Serum's injectible anaesthetic products business including â€“ propofol, bupivacaine and atracurium besylate. BSV holds a significant market share in India for plasma derivatives. The product portfolio comprises a wide range of products such as plasma derivatives, monoclonals, hormones, equine antitoxins and serums, antifungals, anaesthetics, cardiovascular and diagnostic products. BSV has allocated substantial resources towards the research and development of pharmaceutical products in the areas of Novel Drug Delivery, Biotechnology and Biologicals. BSV has a pipeline of novel products and â€œdifficult genericsâ€? and is in discussions with potential partners for commercialization of these products. The novel products include certain New Biological Entities and Novel Drug Delivery systems. The patents for these products will belong to BSV. The anti-infective product is from the drug delivery research and comes under the category of difficult generics. BSV is seeking various partnering models including licensing, co-development, to commercialize its products. ]]> <![CDATA[Pursues collaboration based growth]]> https://biospectrumindia.com/news/95/2675/pursues-collaboration-based-growth.html https://biospectrumindia.com/news/95/2675/pursues-collaboration-based-growth.html Mon, 14 Jun 2010 14:30:00 +0530 16Jubilant Organosys Head:Shyam S Bhartia (Chairman & MD) Business:Integrated pharma industry player with focus on CRAMS and DDDS Startup Year:1978 Address:1A, Sector 16A, Noida-201301, Uttar Pradesh Tel: +91-120-2516601-11 Fax: +91-120-2516628-30 Website:www.jubl.com Jubilant Organosys focuses on the pharmaceutical value chain for products and services such as exclusive synthesis, contract manufacturing, proprietary products, active pharmaceutical ingredients, generic dosage forms, drug discovery services, drug development services, chemistry services, clinical research services, steriles, non-steriles and radiopharmaceuticals. With a revenue of Rs 249 crore in FY 2009-10 from the services business, Jubilant has reported a mild growth over FY 2008-09 when its revenue stood at Rs 242 crore. This growth is because of its efforts to accelerate global drug discovery by concentrating on flexible and hybrid platform of innovative discovery chemistry, biology and insilico services. Besides going for collaborations over the years, the company has also made solid efforts to move higher in vitamin market. The company has five subsidiaries in India that include Jubilant Biosys for discovery informatics and drug discovery services; Jubilant Chemsys for medicinal chemistry; Clinsys Clinical Research for clinical research and bioavailability or bio-equivalence studies; Jubilant First Trust Healthcare for high-quality healthcare services and Specialty Molecules for niche expertise in continuous vapor phase halogenations reaction. In May 2009, Jubilant signed a research collaboration agreement with AstraZeneca, with focus on delivering novel drug candidates into its preclinical pipeline. In June 2009, Jubilant Biosys has entered into a discovery and development collaboration with Endo Pharmaceuticals, a US-based pharma company to develop a portfolio of targets in the area of oncology. In November 2009, Jubilant Organosys and University of Alabama at Birmingham (UAB) entered into a drug discovery joint venture to focus on leveraging their collective innovation and enabling technologies in the areas of oncology, metabolic and infectious diseases. In December 2009, Jubilant and Eli Lilly extended their drug discovery collaboration to preclinical molecules and their development through phase-II clinical trials for five years. The joint venture based out of Bangalore came into existence in October 2008. Lilly and Jubilant had also established a joint venture, Vanthys Pharmaceuticals, for early stage drug development in 2008. On December 16, 2009, Jubilant strengthened its global leadership position in vitamin B3 by setting up new 10,000 TPA Niacinamide plant expected to be ready by the end of 2010. Jubilant is currently ranked amongst the top three manufacturers of niacin and niacinamide (vitamin B3) worldwide and is also the largest producer of beta picoline, a critical raw material for the manufacture of vitamin B3, globally. In 2008, Jubilant signed several R&D deals. In July 2008, Jubilant Biosys, Bangalore, and Amgen, California, announced a drug discovery partnership to develop a portfolio of novel drugs in new target areas across multiple therapeutic areas. ]]> <![CDATA[Preferred CRO partner]]> https://biospectrumindia.com/news/95/6771/preferred-cro-partner.html https://biospectrumindia.com/news/95/6771/preferred-cro-partner.html Mon, 14 Jun 2010 13:11:00 +0530 15Syngene International Head:Goutam Das (COO) Business:Custom research and manufacturing of biopharmaceuticals Startup Year:1994 Address:Biocon Park, Plot No.: 2-3, Bommasandra IV phase, Jigini link road, Bangalore-560099, Karnataka Tel:+91-80-28082808 Fax: +91-80-28083150 Website:www.syngeneintl.com Syngene International (Syngene), a subsidiary of the biopharma major Biocon, is an internationally reputed custom research company with multi-disciplinary skills in synthetic chemistry and molecular biology. The sales revenue of the company increased from Rs 224.60 crore in FY 2008-09 to Rs 252 crore in FY 2009-10 clocking a growth of 24 percent. There are plans of listing Syngene on Bombay Stock Exchange in the coming fiscal. Syngene has consolidated its position as one of the leading custom research organizations in India. The commencement of operations from its recently commissioned biologics pilot plant, coupled with formulation development and other new service offerings, positions Syngene as an ideal partner for providing high quality discovery services at competitive prices in both large and small molecules. The company recently partnered with Endo Pharmaceuticals to develop a novel biological therapeutic molecule against cancer. Under the terms of the agreement, Endo will retain the rights of the molecule developed, and in return, Syngene will receive research fees, milestone payments and success fees from Endo. This is first-of-its-kind in India involving the discovery of a biological therapeutic entity. This also marks Endo's foray into the biologics space and is in line with its strategy of building its pipeline using a virtual discovery approach in conjunction with its in-licensing efforts. Syngene conducts high value R&D in early stage drug discovery and development for a diverse global clients. From early stage discovery and process development through to cGMP manufacturing, Syngene provides customized R&D services to pharmaceutical and biotechnology companies on a strong platform of confidentiality and intellectual property protection. Established in 1994, Syngene was India's first custom research organization to receive special export status from the Government of India. Over the past 16 years, the company has successfully partnered with leading players in the global pharma industry across a range of challenging programs, right from discovery to supply of complex development compounds. The company has developed skills in synthetic chemistry and molecular biology, process chemistry and cell line services. The company is also leveraging the convergence of IT and biotech. Early 2007, the company entered into a research partnership with Bristol-Myers Squibb (BMS). Through this partnership, it is providing R&D services for discovery and early drug development to BMS. Last year, Syngene International has partnered with Sapient Discovery, a US-based biotech company, offering fully-integrated drug discovery services. ]]> <![CDATA[Equipping farmers with technology]]> https://biospectrumindia.com/news/95/2732/equipping-farmers-with-technology.html https://biospectrumindia.com/news/95/2732/equipping-farmers-with-technology.html Mon, 14 Jun 2010 13:01:00 +0530 14Monsanto Head:Amithabh Jaipuria (MD) Business:Production and sales of herbicides, pesticides and hybrid seeds Startup Year:1949 Address:Ahura Center, 5th Floor, 96, Mahakali Caves Road, Andheri (East), Mumbai-400093, Maharashtra Tel:+91-22-28246450 Fax:+91-22-2690 2121 Website:www.monsanto.com Monsanto India clocked an annual sales revenue of Rs 255 crore in FY 2009-10 as against Rs 345 crore in FY 2008-09. The products and solutions provided by the company help farmers to replace manual weeding with cost-effective and efficient weed control mechanisms, reduce production costs and improve quality and yield. Monsanto has its headquarters in St. Louis, Missouri (US). Monsanto supports farmers through two distinct business segments: seeds and genomics, and agricultural productivity; focusing on seeds and biotech enhancements (traits) in corn, cotton, soybean, canola, sugarcane, wheat and vegetables; as well as in herbicide. The India team comprises over 800 employees, 80 percent of whom are from rural backgrounds, making over 10 lakh direct farmer contacts annually. The company has seven seed research breeding stations; three seed processing facilities; one quality assurance laboratory; and one chemistry plant in India. To enhance and accelerate its research initiatives in India the Monsanto Research Centre (MRC) has invested in a new state-of-the-art research facility in Bangalore. The MRC has a modern greenhouse along with a 4,200 sq.ft. net house. It was set up in March 1998 to conduct research in agricultural biotechnology. More than 50 scientists supported by consultants, software programers and administrators work at these facilities. In 1998, Monsanto joined hands with Mahyco to form Mahyco Monsanto Biotech (India) Limited (MMB), which is a 50:50 joint venture. MMB, is not a listed company and was created to bring the benefits of Bollgard cotton technology to farmers in India. In 2002, Bollgard cotton was the first biotech crop to be approved for commercialization in India by the India regulatory body, Genetic Engineering Approval Committee (GEAC). The MMB has sub-licensed the Bollgard technology to 23 Indian seed companies, all of whom are working to introduce the Monsanto gene into their own germplasm. With its continuous success, in 2006, GEAC approved the upgraded variant, Bollgard II, for commercialization. Bollgard is now sold in nine states in India and farmers currently have a choice of over 55 hybrids of Bollgard and Bollgard II. Monsanto has also launched the project SHARE (Sustainable Harvest - Agriculture, Resources, Environment), a sustainable yield initiative with Indian Society of Agribusiness Professionals (ISAP) to improve the socio-economic conditions of 10,000 small-marginal corn and cotton farmers in 1,100 villages in Andhra Pradesh, Maharashtra and Rajasthan within four years by increasing crop productivity through quality inputs, education, market linkages, and community initiatives. ]]> <![CDATA[Enzyme market leader]]> https://biospectrumindia.com/news/95/4547/enzyme-market-leader.html https://biospectrumindia.com/news/95/4547/enzyme-market-leader.html Mon, 14 Jun 2010 12:54:00 +0530 13Novozymes South Asia Head:GS Krishnan Business:Industrial enzymes Startup Year:2000 Address:#9, First Floor, Innovator, International Technology Park, Whitefield Road, Bangalore-560066, Karnataka Tel:+91-80-30506900 Fax: +91-80-28410451 Website:www.novozymes.com Novozymes South Asia is the leading industrial enzymes player in the country with an estimated sales revenue of Rs 268 crore in 2009-10 as against Rs 250 crore in 2008-09. As per BioSpectrum survey, the company's market share has dropped down to 55 percent from 65 percent the previous year. The company holds 80-90 percent market share in textiles and in starch followed by a number of formulators in the country. The company also enjoys 50 to 60 percent market share in baking and another 30 to 40 percent share in animal products. Headquartered in Denmark, Novozymes is a group company of Novo Nordisk. In India, the company is represented by Novozymes South Asia, located in Bangalore. Through its wide network of sales and marketing professionals, Novozymes South Asia is exploring the Indian market for the product range offered by the company. Novozymes had acquired the Biocon's enzyme business in 2007 for Rs 553.19 crore ($115 mn). With this acquisition Novozymes has strengthened its position in India. However, it is facing competition from local firms in some segments. Novozymes India is moving into a new office and R&D facility at Whitefield, Bangalore. The site will also accommodate a number of shared services centers developing in the region. Novozymes continued to focus on growing segments such as detergent, textile and beverage alcohol industries. Thereby, Novozymes establishes R&D operations in India in a big way for the first time. The R&D unit in India will initially focus on optimizing enzyme properties, and application development. Novozymes spends about 13 percent of its turnover for R&D. And around one-tenth of its expenditure for R&D is used in new areas, in line with its strategy of building up new business areas beyond enzymes and microorganisms. Nozymes is focusing on biofuel a big way. The company aims to produce second-generation bioethanol this year that converts waste and agricultural residues into energy. This will be a radical development in the search for new renewable energy sources. Novozymes, last year entered into a collaborative agreement with Praj, a leading company in biofuel technology and plants on advanced biofuels. Together, Praj and Novozymes will optimize the enzymatic hydrolysis processes and the use of enzymes in the production of advanced biofuel. The two companies have worked together for several years within conventional biofuels. Novozymes has a strong commitment to sustainable biofuels and will develop the enzyme technology needed for a successful commercialization of cellulosic ethanol. The company believes that collaboration with Praj will be instrumental in ensuring rapid deployment of cellulosic ethanol in India as well as in other parts of the world. ]]> <![CDATA[Focused on novel products]]> https://biospectrumindia.com/news/95/2670/focused-on-novel-products.html https://biospectrumindia.com/news/95/2670/focused-on-novel-products.html Mon, 14 Jun 2010 12:52:00 +0530 12Bharat Biotech Head:Dr Krishna M Ella Business:Manufacturer of human vaccines and biopharmaceuticals Startup Year:1996 Address:Road No. 65 Jubilee Hills, Hyderabad-500033, Andhra Pradesh Tel:+91-40-23480567, 55510150 Fax:+91-40-23480560 Website:www.bharatbiotech.com Bharat Biotech International Limited (BBIL) specializes in product-oriented research, development and manufacturing of vaccines and biotherapeutics. It has achieved an annual turnover of Rs 271.66 crore in FY 2009-10 as against Rs 241.05 crore in FY 2008-09. Bharat Biotech, established in 1996 by Dr Krishna M Ella and Suchitra K Ella, is one of the largest manufacturers of Indirab (anti-rabies vaccine) in India. It is a WHO pre-qualified manufacturer of Revac-B (hepatitis-B vaccine) for supply to UNICEF and the only vaccine company in India to manufacture and supply a preservative (thiomersol) free vaccine, Revac-Bmcf. Bharat Biotech has developed a three-dimensional business model with emphasis on biogenerics, contract manufacturing and research, and novel products. This strategy has given Bharat Biotech the ability to earn revenues in the short and medium term while focusing on novel patent protected products for the long term. The company has the largest manufacturing capacity for making hepatitis-B (10 crore doses), typhoid vaccine (five crore doses) and rabies (80 lakh doses). The company is planning to invest about Rs 250 crore on conducting clinical trials of seven of its products. These products include therapeutics and vaccines that are at an advanced stage of development. It has product development projects in varying stages for the vaccines and therapeutics, such as malaria, rotavirus, typhoid, Japanese encephalitis, pandemic influenza, chikungunya, and staphylococcus aureus. Rotavac, its oral rotavirus vaccine is slated to enter phase III clinical trials in later half of 2010, with one of the first and largest phase III clinical trial in Indian history encompassing 10,000 infants. The company has invested Rs 185.4-231.7 crore ($40-50 mn) in the clinical trials, with funding assistance from Gates Foundation. The vaccine is expected to hit the market in 2011. Bharat's HNVAC, the pandemic influzenza vaccine, would have its phase III trials started by Q2 2010, making it the first cell culture vaccine for influenza to be developed indigenously. The company's YPHVAC, conjugated typhoid vaccine, has completed phase I clinical trials. Inactivated Japanese encephalitis vaccine produced in vero cell substrate is slated to commence phase I clinical trials during Q3 2010. JENVAC promises to be a vaccine with superior safety and efficacy profile with added thermostable properties. Lysotaphin, a biological antibiotic against Staphylococcus aureus systemic infections would have its IND filing with the US FDA during 2010. THR-100, a novel biotherapeutic against myocardial infractions would have its phase III trials commence during 2010. Phase I and phase II have already been completed in EU and North America. The company expects that the most of the products that are being tested would hit the market in the next two to three years. ]]> <![CDATA[Veteran in veterinary biologicals]]> https://biospectrumindia.com/news/95/5632/veteran-in-veterinary-biologicals.html https://biospectrumindia.com/news/95/5632/veteran-in-veterinary-biologicals.html Mon, 14 Jun 2010 12:41:00 +0530 11Indian Immunologicals Head:KV Balasubramaniam Business:Manufacturer of animal and human biologicals Startup Year:1983 Address:Road No.44, Jubilee Hills, Hyderabad-500033, Andhra Pradesh Tel:+91-40-55512425 Fax:+91-40-23544007 Website:www.indimmune.com Indian Immunologicals Limited (IIL) posted a biotech sales turnover of Rs 272.87 crore in FY 2009-10 as against Rs 231.46 crore in FY 2008-09. The growth rate of the biotech revenue of the company has dropped last year to 17.89 percent from 34 percent. The drop was because of the sluggish growth of the animal biologicas market in 2009. Domestic animal health sales accounted for Rs 115.20 crore (42 percent), human health Rs 116.40 crore (43 percent) and exports Rs 41.30 crore (15 percent). IIL is today the market leader in veterinary biologicals in India and operates one of the largest plants in the world for veterinary vaccines. It is also the third largest animal health player in India with the largest selling brand â€“ Raksha FMD vaccine. Besides maintaining a leading position in veterinary business, IIL has emerged as a major player in the human vaccine market in India, holding the fourth position in the Indian human vaccines market. Its main focus has been on the pediatric segment and human rabies with its flagship product - Abhayrab. IIL's unique marketing channels such as Abhay Clinics (one stop vaccination centers) and Abhay Shoppe (vaccine on call service) have helped it create a strong retail presence. IIL is also a major supplier of vaccines to India's large Universal Immunization Program. Many of its products enjoy strong patronage from veterinarians and as a result, occupy the top slots in market share. IIL has a range of vaccines for cattle, sheep and canine segments. IIL exports its products to over 35 countries in Middle East, Asia Pacific Region, Africa and CIS countries and also to FAO. It has invested over Rs 150 crore for R&D. IIL's R&D efforts are directed at new technologies in vaccines and biologicals. The research center, with a cumulative investment of Rs 7.30 crore is housed in a 1,600 sq.m facility with BSL Level 3 safety and has 50 scientists working on several platform technologies to develop conventional and recombinant proteins, monoclonal antibodies and plant cell derived proteins. IIL spends about 5 percent of sales for R&D activities. IIL's future plans include introduction of recombinant FMD, Brucellosis, Tick, PPR, Canine Parvo and rabies vaccines, apart from conventional vaccines for blue tongue, infectious bovine rhinotracheitis (IBR) and leptospirosis in the animal health market; and hepatitis B, haemophilus influenza type B, human papiloma virus, Japanese encephalitis and combination paediatric vaccines in the human health market. IIL is building new manufacturing facilities for animal vaccines, animal health formulations and human vaccine in Hyderabad at a cost of Rs 131.50 crore and these facilities will be completed by mid 2011. To continue to do well in biologics space IIL plans to enter into veterinary health services, and animal and human bio-therapeutic and diagnostic products, apart from enlarging its current product range in animal and human vaccines. ]]> <![CDATA[Transgenic crop market pioneer]]> https://biospectrumindia.com/news/95/2735/transgenic-crop-market-pioneer.html https://biospectrumindia.com/news/95/2735/transgenic-crop-market-pioneer.html Mon, 14 Jun 2010 12:28:00 +0530 10Mahyco Head:Dr BR Barwale (Chairman) Business:Diagnostic solutions for GM crop testing Startup Year:1964 Address:Post Box No: 76, Jalna-Aurangabad Road, Dawalwadi, Jalna-431203, Maharashtra Tel:+91-2482-233881, 233882 Fax:+91-2482-262002 Website:www.mahyco.com Maharashtra Hybrid Seeds Company (Mahyco) clocked an annual revenue of Rs 220 crore in FY 2009-10 as against Rs 211.12 crore in FY 2008-09. An ISO 9001-2000 company, Mahyco is the first company in India to commercially grow and market transgenic Bollgard (Bt) cotton in 2002, thus ushering in the Bt revolution in Indian agriculture. The company played a pioneering role in the use of hybrids during the Green Revolution in mid-1960s and 1970s. Worldwide, Mahyco was the first company to successfully commercialize F1 hybrid cotton-based on genetic and cytoplasmic male sterility systems. Mahyco was also the first company in India to produce and market hybrid sorghum, pearl millet and sunflower. The company is also developing genetically enhanced crops with the use of gene transfer technology and has a partnership with Monsanto as well as a multi-crop, multi-licensing agreement with several research organizations for bringing agricultural and environment improvement technologies to South Asia. Mahyco is awaiting the Genetic Engineering Approval Committee (GEAC) decision on environmental release of insect-resistant Bt brinjal. â€œWe look forward to a positive decision because it will help lakhs of our brinjal farmers who have been suffering from the havoc caused by the brinjal fruit and shoot borer (FSB). Bt brinjal will help them tackle this pest in an environment-friendly manner and increase yields and farm income,â€? said Raju Barwale, managing director, Mahyco. Bt brinjal, expressing the cry1Ac gene, has been in development and testing since 2000. Mahyco has completed a biosafety dossier encompassing environmental and food/feed safety tests on a variety of animal models including rats, rabbits, chicken, fish, goats and cows. The company has invested Rs 46.42 crore ($10 mn) on the R&D infrastructure and spends Rs 11.60 crore ($2.5 mn) annually for research. Herbicide-tolerant (HT) cotton has also been a focus of Mahyco R&D in the past few years. Cotton farmers face significant difficulty in obtaining farm labour in a timely manner for weeding, which is a requirement at early stages of the crop. Application of post-emergence herbicides is presently the common mode of control of weeds. HT cotton reduces the dependence of the farmer on weeding as the herbicide can be sprayed over the top of the cotton crop that is genetically engineered to be able to survive herbicide application. Mahyco is conducting biosafety related trials on its HT cotton hybrids in the various agro-climactic zones of the country. This apart other investments include, the bioinformatics initiative, wherein investments to the tune of Rs 20-25 crore has been pumped in and this has been done in a limited way for a number of years like in molecular markers. ]]> <![CDATA[Research leader makes healthcare affordable]]> https://biospectrumindia.com/news/95/1159/research-leader-makes-healthcare-affordable.html https://biospectrumindia.com/news/95/1159/research-leader-makes-healthcare-affordable.html Mon, 14 Jun 2010 12:22:00 +0530 9Shantha Biotechnics Head:Dr KI Varaprasad Reddy (MD) Business:Research, development, manufacturing and marketing of biotechnology-based human healthcare products Startup Year:1993 Address:Serene Chambers, 3rd Floor, Banjara Hills, Road No. 7, Hyderabad-500034, Andhra Pradesh Tel:+91-40-23548507 Fax:+91-40-23548476 Website:www.shanthabiotech.com Shantha Biotechnics, acquired by Sanofi-aventis Group in August 2009, registered Rs 334.23 crore turnover in FY 2009-10 as against Rs 247 crore the previous year. In 2009, Sanofi held approximately 95 percent of Shantha's shares. Shantha generated net sales of approximately Rs 284 crore (â‚¬50 mn) in 2009. The company generated net sales of Rs 96.58 crore (â‚¬17 mn) since the acquisition date. Shantha Biotechnics is the first Indian company to develop, manufacture and market a recombinant human healthcare product in India. It is currently focusing its R&D efforts on the development of generic biologicals, novel therapeutic antibodies, proteins and vaccines. The company conducts exploratory research in the fields of oncology, infectious diseases and platform technologies. Shantha Biotechnics has started the phase II clinical trial for rotavirus vaccine at CMC, Vellore. It has plans to start the phase III trial in August 2010. â€œBefore the second quarter of 2010 we will launch the rotavirus vaccine,â€? said Dr Varaprasad Reddy, managing director, Shantha Biotechnics. The company is taking initiatives to start the phase I study of typhoid polysaccharide vaccine. Simultaneously, it is working on conjugated typhoid vaccine that is more effective with less side effects. The vaccine is getting ready for trials. The other products in development include the pneumococcal vaccine and a HPV vaccine, which are being developed in collaboration with John Hopkins University. The company hopes to finish all the studies within four years and the vaccine will be launched in 2014. Dr Reddy said, â€œIf we get the IPV vaccine from Sanofi we will combine it with our pentavalent vaccine and make a hexavalent vaccine.â€? Shantha's Shanvac-B is the first Indian hepatitis B vaccine to be pre-qualified by the WHO, for supplying to the UN agencies globally. Today, Shantha caters to major international markets including Asia-Pacific, Africa, CIS and Latin America in addition to supra nations like UNICEF and PAHO. Shantha is also working on therapeutic monoclonal antibodies and pegylated proteins. The company extends its in-house expertise, core competencies and skill in development of vaccines and biologicals to carry out contract research services. Contract research is undertaken at Shantha's 50,000 sq.ft R&D center. The center is well-equipped with the world-class instruments and other support facilities. The contract research work focus on areas like gene cloning, monoclonal antibody development, expression and purification of recombinant proteins by fermentation, fermentation and purification process optimization, development of polyclonal antibodies, and analytical methods. Shantha has targeted infectious diseases and oncology as its primary areas of interest for conducting R&D activities. It has also taken up collaborative research with premier national and international research organizations. ]]> <![CDATA[Establising R&D lead]]> https://biospectrumindia.com/news/95/2725/establising-rd-lead.html https://biospectrumindia.com/news/95/2725/establising-rd-lead.html Mon, 14 Jun 2010 12:03:00 +0530 7Rasi Seeds Head:Dr M Ramasami ,MD Business:Production and marketing of agri-biotechnology products Startup Year:1973 Address:273, Kamarajanar Road, Attur, Salem - 636102, Tamil Nadu Tel:+91-4282-241007, 242007 Fax:+91-4282-242558 Website:www.rasiseeds.com Rasi Seeds has posted sales revenue of Rs 358.78 crore from its biotech products in FY 2009-10 as against Rs 375.59 crore in FY 2008-09. Other than its hybrids in maize, rice, pearl millet and vegetable crops, Rasi is well-recognized as the leader in cotton hybrids. The company has made tremendous impact in cotton seeds market soon after the introduction of its transgenic Bt cotton hybrid seeds adopting both Bollgard I and Bollgard II technologies. Currently, 32 Bt cotton hybrids of Rasi are being grown in nine Indian states. The company was established with an aim to serve the farmers by developing high quality seeds. Its research products cover over 20 million acres in different agro-climatic regions in India in the past two decades. The company has its R&D facilities at Attur, a rural area in Tamil Nadu. The facility includes 175-acre research farm for crops breeding, 5,500 sq.m transgenic greenhouse and a state-of-the-art seed processing facility. A modern high throughput biotech facility was created for research work on molecular breeding, transgenic crop production, crop viral diagnostics and analytical lab functions. The new R&D facilities have laboratories for crop breeding research, germplasm conservation, insect bioassay laboratory, and library, documentation and other facilities that cover an area of 40,000 sq.ft. The company has plans to operate its vegetable seed business under 'HyVeg' brand with Dr Arvind Kapur as the CEO, supported by a team of experienced vegetable seeds professionals. Vegetable division has a vision to contribute significantly in vegetable seed sector in India and Asia. The company established three new R&D locations and breeding stations for vegetable research in Gurgaon, Bangalore and Kullu. Testing centers for multi-location trials are in place in different agro-climatic zones to evaluate hybrids for suitability. Rasi has established the seed conditioning facilities equipped with processing machinery and equipments. The company's biotech research areas in cotton and different crops include germplasm characterization through DNA-based markers; DNA fingerprinting of proprietary lines; marker-assisted selection in cotton, rice and tomato; bt gene expression and quantification in cotton; and development of molecular markers for genetic purity in seeds. The company's genetic transformation laboratory conducts research on development of transgenic crops by transferring Bt genes in rice, brinjal, and bhindi (okra) to resist against borer pests. Further, attempts are also made to incorporate viral resistance genes in bhindi to protect against bhindi yellow vein mosaic disease, in cassava to protect against cassava mosaic disease, and in cotton to protect against cotton leaf curl virus. Studies to diagnose viral diseases such as cotton leaf curl virus, cassava mosaic virus and bhendi yellow vein mosaic virus are also undertaken through PCR-based assays. ]]> <![CDATA[Capitalizing clinical research in India]]> https://biospectrumindia.com/news/95/2068/capitalizing-clinical-research-in-india.html https://biospectrumindia.com/news/95/2068/capitalizing-clinical-research-in-india.html Mon, 14 Jun 2010 11:51:00 +0530 6Quintiles India Head:Dr Ferzaan Engineer, CEO Business:Contract research organization offering services for phase I-IV studies Startup Year:1997 Address:Nitesh Broadway, 2B, 9/3, MG Road, Bangalore-560001, Karnataka Tel:+91-80-66552100 Fax:+91-80-41156255 Website:www.quintiles.com Quintiles India, a subsidiary of Quintiles Transnational, clocked an annual sales revenue of Rs 375 crore in FY 2009-10 with an Indian market share of almost 50 percent. It offers an integrated services for phase I-IV studies to global biopharmaceutical companies. Quintiles is building a phase I center in Hyderabad in collaboration with Apollo Hospital. The new center will be operational by October 2010. It will be the fourth phase I center for Quintiles globally. The company is a full service contract research organization (CRO) offering the complete range of services and has conducted over 275 global studies, with more than 46,000 patients recruited since 1997. Since its inception, Quintiles India has been involved in global clinical trials for customers in the US, Europe and Japan and this data has been used in global regulatory submissions successfully. Quintiles Data Management (DM) Center in Bangalore has more than 440 personnel and is the largest DM center of Quintiles. This unit has been involved in over 600 global studies of processing more than 1.5 crore pages. The CRO also offers biostatistical services from its Bangalore center. Cardiac Safety Laboratory services is offered from its Mumbai and Bangalore. The ISO 9001:2008 certified lab of Quintiles has a capacity to analyze 400,000 ECGs a year. It provides digital ECG analytical services (including Thorough QT (TQT) studies) to sites in any corner of the globe through its strategically located project managers. Till date, this lab has processed 12 lakh ECGs across more than 750 global studies. In India, Quintiles has a strong pharmacovigilance service offering with more than 220 full-time employees. Having a capacity to process approximately 9,000 cases every month, this service line has processed more than 125,000 cases till date for global and regional studies. The US FDA has inspected nine sites in India and five of them are Quintiles-managed studies, the highest number for any CRO in India. In addition to this, Quintiles sites and facilities have been audited by customers or independent auditors and there has been no critical findings reported. Cenduit, a leading Interactive Response Technology (IRT) solutions provider, is a 50:50 joint venture company between Quintiles and Thermo Fisher. With over 150 employees globally (of which 100 are based in Bangalore) and head quartered at Raleigh, US, Cenduit provides delivery and customer support from its Bangalore office. Quintiles is a 33 percent joint venture partner in Invida, a leading pharmaceutical commercialization services company having operations in 13 countries and employing more than 4,000 people across Asia. In India, Invida has more than 1,100 full-time employees spread across the country. ]]> <![CDATA[Betting on biosimilars]]> https://biospectrumindia.com/news/95/2301/betting-on-biosimilars.html https://biospectrumindia.com/news/95/2301/betting-on-biosimilars.html Mon, 14 Jun 2010 11:44:00 +0530 5Reliance Life Sciences Head:KV Subramaniam, President & CEO Business:Research initiatives in medical, plant and industrial biotechnology Startup Year:2002 Address:Dhirubhai Ambani Life Sciences Center, R-282, TTC Industrial Area of MIDC, Thane-Belapur Road, Rabale, Navi Mumbai-400701, Maharashtra Tel:+91-22-67678000 Fax:+91-22-67678099 Website:www.rellife.com Reliance Life Sciences (RLS), a research-driven, biotechnology-led, life sciences organization and a part of Reliance Industries, clocked sales revenue of Rs 450 crore in FY 2009-10 according to BioSpectrum estimates. Established in 2002, RLS focuses on areas like medical, plant and industrial biotechnology; specifically, these relate to biopharmaceuticals, pharmaceuticals, clinical research services, regenerative medicine, molecular medicine, novel therapeutics, biofuels, plant biotechnology and industrial biotechnology. Around 70 percent of RLS' topline growth comes from biopharmaceuticals. There is a specific focus on biosimilars. The company has already launched four biosimilars - ReliPoietin (recombinant erythropoietin), ReliGrast (recombinant Granulocyte Colony Stimulating Factor (G-CSF)), ReliFeron (recombinant interferon alpha), and MIRel (recombinant reteplase-tissue plasminogen activator) - in the domestic market. India and the rest of the world (RoW) markets would be the company's primary focus for the launch of these products. The company is expected to launch another four products this year including one in Europe. The company has set up the first cord blood repository in South Asia and offers cord blood banking services to public. This is the first cord blood repository in the world to be accorded with a licence by an official regulatory authority, Food and Drug Administration (FDA) and is also accredited by the American Association of Blood Banks (AABB). RLS is developing novel therapeutics for the treatment of cancer, infectious diseases, inflammatory disorders, ocular disorders and neurodegenerative disorders. The discovery program is based on siRNAs and monoclonal antibodies. Other products in development include a wide range of novel research-led, autologous and allogenic cell therapies and tissue engineered products. This will in turn consolidate its position in the regenerative medicine market. The company also focuses on developing stem cell therapies, right from research, cell processing in cGMP facilities, clinical research and clinical practice. Cell-based therapies from Reliance Life Sciences aim to fulfill unmet patient needs in the areas of cardiac disorders, neural degeneration, spinal cord injury, metabolic disorders like diabetes, ophthalmic diseases, hematological diseases, oncological diseases, burns and wound management, diabetic and venous ulcers, and cartilage disorders. RLS is developing an India-centric, global biofuels initiative covering biodiesel, from jatropha and other non-food oil seed crops; bioethanol, from cellulosic biomass; and biobutanol, from cellulosic biomass. Reliance has successfully grown jatropha along with horticulture and medicinal intercrops. It has commissioned a 6,500 tonnes per year pilot plant in Kakinada, Andhra Pradesh, for biodiesel production and developed second-generation processes for bioethanol and biobutanol production at a lab scale. ]]> <![CDATA[Agri market leader]]> https://biospectrumindia.com/news/95/3532/agri-market-leader.html https://biospectrumindia.com/news/95/3532/agri-market-leader.html Mon, 14 Jun 2010 11:37:00 +0530 4Nuziveedu Seeds Head:M Prabhakar Rao Business:Manufacturer of hybrid cotton seeds Startup Year:1973 Address:NSL ICON, 8-2-684/2/A, Plot No. 1-4, 4th Floor, Road No. 12, Banjara Hills, Hyderabad-500034, Andhra Pradesh Tel:+91-40-23327939/49/59 Fax:+91-40-23327919 Website:www.nuziveeduseeds.com Nuziveedu Seeds Limited (NSL), one of the leading hybrid seed companies in India, has posted an annual turnover of Rs 476.86 crore from its biotech products in FY 2009-10 as against Rs 449.58 crore the previous year. The company has sold more than 68 lakh packets of bt cotton seeds in 2009-10 as against 64.40 lakh packets in 2008-09 and 48.42 lakh packets in the year 2007-08. Nuziveedu Seeds Private Limited (NSPL) is the flagship company of NSL Group. NSPL is the largest seed company in India. The company has well-established state-of-the-art infrastructure for plant breeding and biotech research. The company's research farms spread over 12 different agro-climatic conditions of the country. The company's supply chain infrastructure including the largest conditioned seed storage facilities have world-class standard. The company markets its products under nine umbrella brands through their own marketing network, associate companies and through special marketing arrangements with organizations like KRIBHCO, NSC and ITC. Nuziveedu has the largest market share of 36 percent in cotton hybrid seeds and it is also the number one supplier of varietal rice seeds in the private sector. Its products are being used by more than one crore farmers. The company aims to reach Rs 1,000 crore turnover in FY 2010-11. The company's hybrid seeds are produced in collaboration with about 42,000 seed producing farmers and are used by 50 lakh farmers across the country. The cotton seeds supplied by the company are planted in 35-40 percent of the cotton area in the country and contribute in producing 40-45 percent best quality cotton in India. The company's R&D wing has developed excellent hybrids in cotton, 'Bunny' and 'Mallika', which produce very high-quality cotton fiber besides giving high yield to farmers. The company has also developed several excellent hybrids of rice, maize, bajra and jowar. It has also invested in renewable power generation, textiles, cotton procurement and trading, sugar, power and IT infrastructure businesses. After establishing itself as the top player in cotton seeds market, NSL is now working on increasing its market share in rice, maize, jowar, bajra, sunflower, chillies, soybean, wheat and various vegetable crops. At present NSL is using the GM traits for imparting 'insect resistance in cotton'. NSL has research collaborations with a number of reputed national and international research institutions. The company has invested more than Rs 12 crore in R&D this year as against Rs 7 crore the previous fiscal. The company has marketing alliances with a number of companies. Some of the products of company are sold through subsidiary companies namely-Prabhat, Pravardhan and Yaganti, and Bt cotton hybrids are sold through co-partners like Rallis India and Navbharat Seeds. ]]> <![CDATA[Panacea leverages new opportunities]]> https://biospectrumindia.com/news/95/8024/panacea-leverages-new-opportunities.html https://biospectrumindia.com/news/95/8024/panacea-leverages-new-opportunities.html Mon, 14 Jun 2010 11:30:00 +0530 3Panacea Biotec Head:Dr Rajesh Jain, JMD Business:Manufacturer of pharmaceuticals, biopharmaceuticals and vaccines Startup Year:1984 Address:B-1, Extn./G-3, Mohan Cooperative Industrial Estate, Mathura Road, New Delhi-110044 Tel:+91-11-41679000, 41678000 Fax:+91-11-41679070, 26940199 Website:www.panaceabiotec.com Panacea has registered a total biotech turnover of Rs 703.10 crore in 2009 with a 17 percent growth over last fiscal. The vaccine segment of the company too has grown by 18 percent and registered a turnover of Rs 644.40 crore. The company registered a turnover of Rs.882.30 crore in 2009-10 with a growth rate of 14 percent over last year. The company has played a key role in eradicating polio by supplying more than 600 crore doses of oral polio vaccine to the Government of India and UNICEF. The company has eight WHO pre-qualified vaccines including innovative fully-liquid combination tetravalent vaccine Easyfour (DTwP-Hib) and pentavalent vaccine Easyfive (DTwP â€“ Hep Bâ€“ Hib). It is one of the first companies to develop fully-liquid pentavalent vaccine Easyfive (DTwP-HepB â€“Hib ) and bivalent OPV globally. The pharma product portfolio of Panacea Biotec includes highly-innovative prescription products in important therapeutic segments like pain management, diabetes and cardiovascular disease management, renal disease management, organ transplantation, osteoporosis management, oncology and paediatric immunization. The brands Willgo, Glizid, Glizid M, Panimum Bioral, Pangraf, Sitcom, Livoluk Fibre, Vacosteo and Fosbait hold the top five positions in their respective therapeutic segments. In FY 2009-10, Panacea Biotec has unveiled nine products in highly-specialized therapeutic segments in domestic market that earned revenues of Rs 7 crore in FY 2010-11. Extensive portfolio of innovative products is the outcome of company's focus on R&D. The specific research areas of the company are developing new chemical entities, biological entities, novel drug delivery systems, novel therapeutic peptides and fully-human monoclonal antibodies, vaccines and biotech-driven products. Dr Rajesh Jain, joint managing director, Panacea Biotec, said, â€œWe believe that innovation delivers sustainable business value. With strong fundamentals, innovative product pipeline and increased focus on launching products in developed markets we would be growing at a much faster pace to realize our vision.â€? Panacea Biotec has novel cGMP compliant manufacturing facilities for pharmaceuticals, vaccines, and biopharmaceuticals. â€œDevelopment of Pandyflu (Pandemic flu vaccine) within short span of time was test of our technological, managerial, operative and administrative competency. I am proud that the company has once again exhibited its strength. We are determined to continuously reinvent ourselves and fuelling innovation engine for growth,â€? said Dr Jain. Panacea Biotec has set up a new BSL2 level manufacturing unit (high-containment facility) with BSL 3 practices in Punjab for manufacturing of Pandyflu with an annual capacity of 4.5 crore doses. This would enable the company to supply the vaccine globally. ]]> <![CDATA[Vaccine leader takes on swine flu]]> https://biospectrumindia.com/news/95/1739/vaccine-leader-takes-on-swine-flu.html https://biospectrumindia.com/news/95/1739/vaccine-leader-takes-on-swine-flu.html Mon, 14 Jun 2010 11:16:00 +0530 2Serum Instituteof India Head:Dr Cyrus S Poonawalla, Chairman Business:Manufacturing and marketing of life-saving immunologicals Startup Year:1966 Address:212/2, Hadapsar, Off Soli Poonawalla Road, Pune- 411028, Maharashtra Tel:+91-20-26993900 Fax:+91-20-26993921 Website:www.seruminstitute.com Serum Institute of India clocked a total sales revenue of Rs 850 crore in FY 2009-10 according to BioSpectrum estimates. Last year, the company was in the news for being the first company in India approached by the World Health Organization (WHO) to develop and manufacture the H1N1 vaccine to fight the swine flu pandemic. As of now, official reports claim that the indigenously produced vaccine has entered its final trials. The vaccine has proven to be safe and the mass production license is likely to be given in mid-June 2010. Clinical trials of the nasal form of the vaccine have begun in 330 patients in sites like Gujarat, Kolkata, Indore, Bangalore and Pune. Unlike other vaccine manufacturers who import the bulk, Serum Institute is the only indigenous manufacturer of HIB vaccine in India. HIB vaccine is fully manufactured in India and it is given to infants along with DPT or alone. Earlier, efforts by the UNICEF for HIB immunization met with little success as the prices were very high, which led to limited access of the vaccine in many poor countries. Serum Institute supplies the HIB vaccine at a lower price. The vaccine is available under the brand name, SiiHIB Pro. Serum has plans to launch a meningitis vaccine. The vaccine, which has completed phase I, II and II/III trials in Africa and India, will be introduced in Africa in 2010. Dr Cyrus S Poonawalla, chairman of the company, said, â€œThis will be a landmark initiative for us because this is another vaccine which we are developing in collaboration with PATH, especially for African countries and Haaj tourists. We will be the only company in the country for years to come, with such a vaccine.â€? This apart, Serum's biopharmaceutical initiative has been rolled out this year, starting with European Patent Office (EPO). The initiative was rolled out three years back. Also, at present, the company is working on novel vaccines and also on NDDS initiatives. Serum Institute has also got an approval from the US FDA for their oncology facility, the construction of which started in 2006 and which they will be rolling out in a few months time. Serum had hiked its holding in Panacea Biotec on October 14, 2008 through bulk deal at Rs 220 per share. Part of this equity stake was bought from South Korean asset management firm, Mirae. Serum now has seven percent stake in the New Delhi-based Panacea Biotec. This deal is significant as Serum Institute and Panacea are the top two Indian firms in the vaccine business. Serum Institute of India has also set up Serum Bio Pharma Park, India's first biotech Special Economic Zone (SEZ) and developments on this project is still in the process. The project is due to be completed by 2012-13. The premises have already been prequalified by the WHO. An investment of Rs 1,200 crore by Serum has been made for the purpose. ]]> <![CDATA[Biocon rides on emerging markets]]> https://biospectrumindia.com/news/95/2532/biocon-rides-on-emerging-markets.html https://biospectrumindia.com/news/95/2532/biocon-rides-on-emerging-markets.html Fri, 11 Jun 2010 17:11:00 +0530 1BIOCON Head:Kiran Mazumdar-Shaw Business:Biopharmaceuticals Startup Year:1978 Address:20th KM Hosur Road, Electronic City, Bangalore â€“560100, Karnataka Tel:+91-80-28082808 Fax:+91-80-28523423 Website:www.biocon.com With a total revenue of Rs 1,180 crore in FY 2009-10, Biocon is back to the number one position in the BioSpectrum-ABLE Top 20 Survey 2010. after a gap of three years. Including its German subsidiary, Axicorp, the PAT of the company stood at Rs 293 crore with a year-on-year growth of 215 percent. The company also increased its licensing revenue from Rs 11 crore to Rs 51 crore. Biocon's insulin business grew by 11 percent. In FY 2009-10, Biocon entered several new markets like Brazil and Chile. It also secured registration approvals in five countries during this year. The statin business of the company registered a year-on-year growth of 26 percent despite pricing pressures owing to enhanced capacity enabled by improved productivity. Simvastatin remained as the largest revenue incurring product by sales but Atorvastatin and Rosuvastatin are expected to boost the revenue in the coming years. Axicorp posted 93 percent growth. The growth primarily came from more efficient sourcing of products for its business, restructuring of its sales force, and winning AOK, BKK and DKK tenders for several generics. Biocon has acquired a new API facility in Hyderabad and is expanding its monoclonal antibody facility of its subsidiary, Biocon Biopharmaceuticals, which has recently been wholly-acquired from its Cuban partner. Its oncology segment posted 59 percent growth with brands like Abraxane and BioMAb EGFR as key contributers. The company plans to expand its auto-immune portfolio into dermatology and rheumatoid arthritis by launching the immunotherapy division this year. Kiran Mazumdar-Shaw, CMD of Biocon, said, â€œWe are confident of sustaining growth momentum in the years ahead given our increasingly differentiated profile enhanced by key global partnerships. This offers us larger and lucrative opportunities in both emerging and developed markets.â€? Considering R&D pipeline, the company has strengthened its partnership with Mylan for developing biosimilars for the global markets. Its novel pipeline has achieved significant milestones spearheaded by a key IND filing with the US FDA for its oral insulin program IN105. Biocon's coveted T1h program, a novel anti-cd6 targeting monoclonal antibody, is also entering phase-III clinical trials for psoriasis. Additionally, its novel anti-CD20 molecule has completed preclinical studies and is expected to move into the clinical trial in India this year. Among other developments, Biocon has signed a MoU with Malaysian Biotechnology Corporation to explore collaboration and potential investment in Malaysia's biotech industry. Biocon is in talks with Biotech Corp to manufacture biopharma products and formulations there. Having a strong focus on R&D, the company in FY 2009-10, spent Rs 125 crore in research, a 45 percent rise over the previous year's investment of Rs 80 crore. ]]> <![CDATA["Life sciences is the sunrise sector that needs nurturing"]]> https://biospectrumindia.com/news/95/1613/life-sciences-is-the-sunrise-sector-that-needs-nurturing.html https://biospectrumindia.com/news/95/1613/life-sciences-is-the-sunrise-sector-that-needs-nurturing.html Wed, 05 May 2010 11:32:00 +0530 Vishal Gandhi, vice president,life sciences and technology, YES Bank, New Delhi YES Bank, started six years ago, is one of the fastest growing new generation banks in India. The bank has launched financial products for life sciences industry and has invested in a few companies. Vishal Gandhi, vice president of life sciences and technology, YES Bank, in an interview with BioSpectrum, speaks about the role of the bank in promoting the life sciences sector and future of the industry. Q What made Yes Bank opt for biotech industry that has long incubation period? Life sciences and healthcare have been identified as key growth segments of the Indian economy and India is expected to emerge as a major player in these segments. Yes Bank has identified these industries as key sunrise sectors and is committed to support its growth. The bank has institutionalized a highly empowered quality team with relevant industry and commercial expertise to focus on specific segments of this industry. Yes Bank also has domiciled knowledge experts who adopt a money doctor approach to provide diagnostic and prescriptive solutions customized for the segment. Q What kind of partnership does the bank has with industry associations? YES Bank is a member of associations like ABLE, FICCI, CII, BCIL, ASSOCHAM, OPPI, IDMA and ADMA. It recently partnered with ASSOCHAM to conduct a study on Indian healthcare services, a report of which was released in 2009. YES Bank and OPPI have joint hands to conduct a study titled Indian Pharmaceutical Sector: Vision 2015. This report on biotechnology, pharma and healthcare provides current analysis as well as future vision for the benefit of each sub-segment of the life sciences and healthcare industries. Q What initiatives have been taken along with the government to promote life sciences sector? Being a member of the working committee of the Department of Biotechnology (DBT), Government of India, YES Bank has provided inputs for the National Biotech Policy. The bank is also a member of the screening committee of Small Business Innovation Research Initiative (SBIRI) scheme of DBT till mid 2008 and had partnered with them to scout for right targets from financial perspective. Q What kind of financial solutions are offered by YES Bank to life sciences sector? Nurturing this sunrise sector is the main priority for YES Bank. The bank has completed a good number of deals-M&A, capital raising advisory, vanilla lending, or structured solutions for projects and trade finance products. These were made possible because of the deep understanding of the dynamics of various sub-segments of the industry ranging from biosimilars, CRAMS and diagnostics. Q How does the future of life sciences industry looks like? Life sciences industry has got immense potential, but it has to be boosted by the private sector participation. The government bodies like ICMR, DBT and DST have supported the R&D of commercial products. But as compared to 2000-2005, during which the biotech industry registered faster growth, the biotech industry needs more thrust now. The entry of bigger biotech companies like Amgen, Biogen, Roche into India to introduce biotech-based products will definitely help the industry to grow further. YES Bank has given more stress to the biotech industry not only for profit but also for its contributions to address human health-related problems in a major way. Rahul Koul in New Delhi ]]> <![CDATA["India has a wealth of scientific expertise"]]> https://biospectrumindia.com/news/95/1896/india-has-a-wealth-of-scientific-expertise.html https://biospectrumindia.com/news/95/1896/india-has-a-wealth-of-scientific-expertise.html Wed, 05 May 2010 11:30:00 +0530 Dr Rajan George, executive VP and chief technology officer, Paladin Biosciences, Canada Paladin Biosciences is a division of Paladin Labs, a publicly-traded specialty pharmaceutical company listed on the Toronto Stock Exchange. Paladin Biosciences has been in operation in Edmonton, Canada, since 2001, originally under the name ViRexx Medical Corp and in 2008, it was acquired by Paladin, one of the Canada's leading specialty pharmaceutical companies. Paladin Biosciences has been developing innovative targeted therapeutics for individuals who suffer from infectious diseases and cancer. Using its proprietary Chimigen Platform Technology, Paladin Biosciences has developed a portfolio of biotherapeutic agents to meet major unmet medical needs such as treatments for chronic hepatitis B and hepatitis C virus infections, avian and swine influenza, alphavirus infections, malaria and cancer. The company is now on the look out for co-development as well as licensing opportunities with companies in Asia, especially in India. In an interview with BioSpectrum, Dr Rajan George, executive vice president and chief technology officer of Paladin Biosciences, talks about his company and its expansion strategies. Q Which are the major therapeutic areas of focus for Paladin Biosciences? Paladin is targeting various infectious diseases, mainly hepatitis B and hepatitis C. The lead product of the company is a therapeutic vaccine for the treatment of patients with chronic hepatitis B virus infections. Chimigen HBV Therapeutic Vaccine is currently in late stage preclinical development and there are plans to initiate a phase-I clinical trial soon. The company is actively looking for partners in Asia to advance this program, as it is a major unmet medical need in Asia. Other product candidates in development are Chimigen HCV therapeutic and prophylactic vaccines, prophylactic vaccines for influenza (H5N1 and H1N1), alphaviruses such as encephalitis, chikungunya, and malaria. We are also developing a bionanoparticle technology to deliver siRNA molecules to various cell types for RNAi and antiviral/ immunotherapy combinations. Q Can you elaborate on the technological aspects of Chimigen platform? The company's proprietary Chimigen platform, which incorporates functional elements of both antigen and antibody-based technologies, is a unique, versatile and highly adaptable platform that can be used for developing immunotherapeutic agents, RNAi and for cell-specific delivery of biologicals including siRNA. The Chimigen platform is a versatile vaccine technology designed to target vaccines to specific receptors on antigen presenting cells, especially dendritic cells, to elicit both cellular and humoral immune responses in hosts. It is used to develop therapeutic vaccines for patients with chronic viral infections as well as prophylactic vaccines to prevent infections. Chimigen vaccines are recombinant proteins that have selected antigens fused to the Fc fragment of a murine monoclonal antibody through proprietary peptide linkers. This approach allows efficient substitution of a desired antigen in the Immune Response Domain (IRD) on the Target Binding Domain (TBD) backbone, permitting the production of very effective multivalent vaccines. TBD contains the antibody portion of the fusion protein and it allows the vaccine to bind with specific receptors on the surface of dendritic cells and other antigen presenting cells, facilitating antigen uptake, processing and the appropriate antigen presentation. This results in the induction of a broad immune response, both cellular (T cell) and humoral (B cell, antibody) immune responses, against the selected antigen(s). Induction of a broad and balanced immune response allows the technology to be used to develop both prophylactic and therapeutic vaccines and is a key advantage of the Chimigen technology. This technology is designed to overcome host tolerance to chronic infections and cancer, and this will allow Paladin to develop a wide range of biotherapeutic agents targeting major unmet medical needs. Q Does Paladin has APAC specific strategy and what are its partnership plans in the region? Paladin's lead program targets hepatitis B virus infections, which are prevalent in many Asian countries, and its technology has broad application in other diseases afflicting the region. The company is not keen on expanding its operations in Asia, but it is looking for partners in major Asian markets to develop Chimigen HBV Therapeutic Vaccine and other therapeutic products. This partnership could be in the areas of clinical trials and licensing. The ideal way is to partner with companies in Asia, especially in India, which have established vaccine and biotherapeutics development expertise. Q Why do you think India is the most suitable place for your company to establish partnerships? India has a wealth of scientific expertise and is already emerging as a biotech powerhouse. To realize its full potential, the Indian economy must continue to grow and bring more and more of its people to the global platform, and the Indian government must recognize the importance of a strong, innovation-based life sciences industry. Other than this, building partnerships with non-Indian biotechnology enterprises that have technologies applicable to the unmet medical needs of India would be an ideal approach to make India a leading player in the life sciences sector. Q What are the business strategies of Paladin for the Asian market? Paladin focuses on region-based product development. The company carries out preclinical studies as well as clinical sample evaluations. It expects manufacturing, product development and clinical trial expertises from the prospective partner. The Asian partner could take the preclinical product to either global or regional markets, as Paladin is very flexible in these areas. The company anticipates very limited competition in the therapeutic areas which it is actively involved in. Ajeesh Anand in Bangalore ]]> <![CDATA["We have a focused strategy for India"]]> https://biospectrumindia.com/news/95/1411/we-have-a-focused-strategy-for-india.html https://biospectrumindia.com/news/95/1411/we-have-a-focused-strategy-for-india.html Wed, 05 May 2010 11:24:00 +0530 With over 20 years of experience in providing bioservices to the biotech industry, New Delhi-based BI Biotech is looking forward to a significant growth in the coming years. In an interview with BioSpectrum, Vinaya K Dubey, director of sales and marketing, BI Biotech India, shares his views on the future plans of the company, segments catered by it and challenges faced by biosuppliers in India. Q Which are the services offered by BI Biotech to the life sciences industry in India? BI Biotech India was established with an objective of providing high quality research products that includes consumables and equipments with excellent customer support and on-time delivery through its distribution network. The company provides wide range of proteins, antibodies, ELISA kits, stem cell products, gene array products, siRNA, transfection reagents and other consumables and instruments for complete solutions for laboratories working in genomics, proteomics, cell biology, immunology and drug discovery. Q What are the different segments and customers that the company caters to? BI Biotech India has a focused strategy for the Indian biotech industry by initiating major divisions like genomics, proteomics, cell biology, immunology and healthcare. Our major clients are pharma and CRO companies including government institutions. Q What are the major contributors to the growth? BI Biotech India has registered a revenue growth of 21 percent in 2009-10 and in 2010-11, the company is expected to grow at 30–35 percent. The three fundamentals —value, service and support—are the major factors that contributed to the success and growth of the company. Q What are the key partnerships and collaborations? The company has partnerships with some of the world-renowned companies like Abnova, AnaSpec, Bachem, Bellco Biotechnology, Cedarlane Laboratories, Global Stem, RayBiotech, R&D Systems, SABiosciences, and Santa Cruz Biotechnology. These partnerships helped to bring out comprehensive range of products that fulfills the need of researchers in the area of specially cell biology. Q What are the main challenges as far as the product supply is concerned? One of the major challenges faced by biosuppliers in India is the delay in purchase process that ranges from weeks to several months, which affects the overall product supply. More importance to price over quality/technology is also a major obstacle to the purchase process in India. Q How is the opportunity for biotech industry in India shaping up? India has the capability to become a world leader in biotech sector in the coming years. The efforts in this direction have already started so as to bring the public and private partnerships to a common platform. Foreseeing the new opportunities, BI Biotech India reviews its strategy from time to time and strikes new partnerships to tap the business opportunity. Q Does BI Biotech has any plans to expand its product line? BI Biotech India is focusing on two major business segments in the biotech industry—clinical trial market and providing solutions for the needs of scientists from immunology and cell biology segments. The company has been entering into new partnerships in the areas of stem cell and nanotechnology, especially in the healthcare sector. Rahul Koul in New Delhi ]]> <![CDATA[Monoclonal antibodies: A profitable segment]]> https://biospectrumindia.com/news/95/5316/monoclonal-antibodies-a-profitable-segment.html https://biospectrumindia.com/news/95/5316/monoclonal-antibodies-a-profitable-segment.html Wed, 05 May 2010 11:22:00 +0530 Companies all across the world are in pursuit of tapping the booming monoclonal antibodies market (mAbs). Between 2005 and 2008, the market witnessed an exponential growth wherein the global mAbs market more than quadrupled in just four years from Rs 31,101 crore ($7 bn) in 2004 to Rs 1.55 lakh crore ($35 bn) in 2008 with the 'Big Four'-Roche, Genentech (now a subsidiary of Roche) , Johnson & Johnson and Abbot leading the race. Therapeutic mAbs market is dominated by the 'Big Five' products-Avastin and Herceptin for oncology); Humira and Remicade for autoimmune and infectious disease (AIID); and Rituxan for oncology and AIID. In 2006, these products accounted for 80 percent of the revenues with Roche-Genetech owning three of these products. Industry experts are optimistic about the mAbs segment, which is expected to touch a compound annual growth rate (CAGR) of 14 percent between 2006 and 2012, surpassing growth rate of 0.6 percent in the more traditional, small molecules market. Dr Rustom Mody, chief scientific officer and director - quality, Intas Biopharmaceuticals, includes the Rs 44,430 crore ($10 bn) sales of mAbs for diagnosis and as reagents in research, so the market is worth Rs 2.22 lakh crore ($50 bn). The boom in the mAbs segment is due to the increasing popularity of targeted therapeutic mechanism approaches among scientific community, particularly in disease segments like oncology and AIID. In case of cancer, conventional treatment of chemotherapy and radiation therapy, it often results in relapse and such patients ultimately die either from their cancer or due to toxicity levels of the therapy. The development of mAbs for these disorders have been studied to improve the therapies and minimize the toxicities associated with standard therapies. MAbs are designed to demonstrate efficacy with low toxicity and are expected to reduce overall treatment and hospitalization costs associated with the side effects and opportunistic infections, which can result from chemotherapy or radiation therapy. According to an independent market analyst, Datamonitor, with key individual mAb product franchises forecast to record peak sales growth through broadening horizontal indication and the launch of new products in the next few years, this rapid expansion is expected to continue. The commercial dominance of the big five is expected to continue till 2012, with the same products forecast to account for 70 percent of 2012 mAbs revenues. Datamonitor also predicts that Genentech/Roche will retain their dominance over the mAbs market till 2012, due to their ownership of three of the big five products. Oncology and AIID will remain the main focus areas for mAbs segment as they are the disease areas addressed by the 'big five'. Industry analysts point out that new players such as Biogen Idec, Amgen, Novartis and UCB Pharma, Bristol-Myers Squibb and Sanofi-aventis will expand their presence in the mAbs market by 2012. Growth demand for mAbs With dwindling R&D pipelines, patent expiration of blockbuster products, and apprehensions over subsequent dip in revenues till 2012, most pharmaceutical companies have chalked out a 'mAbs strategy'. This was evident from a spate of licensing deals between pharma and biotech companies in the mAbs space and a spree of biotech firms being acquired by pure pharma companies in the recent past. In 2006, GSK etched a mark with the company licensing a drug for leukaemia from Genmab for Rs 9,341 crore ($2.1 bn), the largest ever deal in terms of value in the mAbs segment. The year 2009 saw some mega mergers with the Roche-Genentech deal gaining the center of attraction. â€œMAbs offer an enormous amount of target specificity that reduces the nonspecific, untoward side effects commonly observed in small molecules. Many companies across the globe have mAbs products in advanced clinical trials stage,â€? says Dr Mody. Cancer and anti-infammatory segments contribute 51 and 30 percentages respectively, according to a report by Datamonitor and Frost & Sullivan. Experts from the scientific community point out that human mAb has a higher rate of technical success and negligible levels of toxicity and lesser degrees of side effects. â€œThe platform technology can easily be adapted for novel mAbs as the variability that can be introduced within the antigen-binding domains of mAbs increases their molecular diversity and extends the range of potential therapeutic applications,â€? says Dr Mody. On the international front, numerous factors have motivated the companies to opt for mAbs. There has been an upsurge in demand for mAbs products because very few chemical-based products are available to provide effective cure for diseases such as cancer, asthma, anti-inflammatory, osteoporosis and opthalmology. â€œChemical-based products have failed to provide remedy for oncology diseases. The technological competency of mAbs helps to get rid of these diseases,â€? says Sujay Shetty, associate director of pharmaceutical and lifesciences, PricewaterhouseCoopers India. The commercial success of blockbuster products like Avastin and Herceptin for oncology; Humira and Remicade for AIID; and Rituxan for both oncology and AIID, has been a stimulus for the companies rolling out a large number of R&D projects in mAbs. Remicade has been the best selling antibody since 2004 and was the market leader with sales of over Rs 28,915 crore ($6.5 bn) in 2008, followed by Rituxan, Avastin, Herceptin and Humira. The first three products made it to the top ten and all five products made it to the top 20 global best selling human medicinal brands. Till 2008, there were over 200 antibodies out of 630 biologics in clinical trials testing for cancer, arthritis, infections, asthma, macular degeneration, osteoporosis, diabetes and other chronic diseases. Increased sales and profitability have attracted mainstream pharmaceutical companies towards mAbs. The pressure of pricing is much lower in this space. In India, the demand for mAbs is increasing and there is an upsurge in the number of Indian companies venturing into this space. India has capitalized on its so-called 'low cost destination' advantage. â€œHuge investment is needed to establish large scale manufacturing facilities for mAbs. The fund needed for setting up large scale operations is still lower in India as compared to developed markets. By establishing their operations in India those developed markets can fulfill their growing demand for mAbs products. India offers the possibility of improving their profit margins,â€? says Dr Mody . Biocon and Dr Reddy's Labs, two of India's top life sciences companies, have already launched their products in the market successfully. The latest debate among the biotech circles are the opportunities that biosimilar mAbs has to offer to companies. The global biosimilars market is primarily dominated by three main components â€“ mAbs, therapeutic proteins and vaccines. In 2009, 29 mAbs were approved and marketed for therapeutic use. With the patent expiry of products like Herceptin, Humira and Rituxan by 2020, generic versions of these products are in the pipeline of many Indian players. Analysts predict that it will be a tussle for dollars for Indian players in the coming decade. Currently there are about 25 Indian companies operating in the space bringing out at least 40 products in the market and many of them are well positioned to compete in the global mAbs landscape. â€œThis product class is gaining maturity and within five years, when the second wave of biologicals are going to be off-patent, many of which are blockbuster mAbs, India is likely to dominate biosimilar mAbs development and manufacturing,â€? adds Dr Mody. In terms of funding, venture capital firms are optimistic about mAbs space. â€œGlobally, venture capitalists are willing to invest in two areas â€“ interferons and mAbs,â€? says Shetty The main reason for this is the patent expiry of mAbs worth Rs 47,154 crore ($10.6 bn) by 2018. MAbs is the focus area for many pharma and non-pharma companies and hence R&D, M&A and licensing deals are happening in billion dollars for this class of products. A venture capitalist from a leading firm in India told BioSpectrum (without mentioning any names) that he was aware of many reputed VC firms (which includes his firm) in India are looking at investing in mAbs space in the event of a rising number of Indian companies venturing into the segment. mAbs in India Biocon was the first Indian company to come up with its mAbs product, BIOMAb-EGFR, and the product was granted regulatory marketing and manufacturing approval in India in September 2006. The product is a therapeutic monoclonal antibody-based drug for treating solid tumors of epithelial origin, such as head and neck cancers. This novel drug is engineered to specifically target and block the epidermal growth factor receptor (EGFR) responsible for the proliferation of cancer cells. Dr Harish Iyer, R&D head, Biocon, â€œAs far as Biocon's portfolio is concerned, we have one product in the market from our stable. BIOMAb EGFR (Nimotuzumab) is a monoclonal antibody that specifically binds to the extracellular domain of EGFR and prevents signal transduction. It is used in the treatment of advanced squamous cell carcinoma of the head and neck region with concurrent chemotherapy and/or radiotherapy.â€? It is also being globally studied in a range of solid tumor types, including colorectal cancer, lung cancer, glioma and pancreatic cancer. â€œBiocon has also partnered with Mylan for co-developing biosimilar mAbs. This is a co-development, cost sharing agreement for a bunch of molecules that are currently in development,â€? says Dr Iyer. Apart from being a low cost manufacturing destination, Indian companies have the upper hand of offering mAbs products at comparatively lesser price margins. At the launch of BIOMAb -EGFR, Dr Kiran Mazumdar-Shaw, chairman and MD of Biocon, said, â€œBIOMAb -EGFR is competitively priced to make cancer treatment more affordable. â€œIn 2007, Dr Reddy's Labs came out with the novel concept of producing the biosimilar version of Rituximab, a version of Roche's cancer therapy, which could allow a greater access to the drug at half the price of the original. With the more complex molecules like mAbs, Dr Reddy's believes that the preferred strategy is to systematically develop the entire spectrum of development and manufacturing capabilities. The complexity of the molecules and the processes means a close integration of all the relevant skills within one organization with direct links between the manufacturing groups and the process, analytical, pre-clinical and clinical development groups. World-class facilities and laboratories of Dr Reddy's, the scientific depth of its team, the robustness of the development strategy and the focus on quality issues were some of the key factors that contributed to the successful development of a complex molecule like Reditux. Reditux is the second product from Dr Reddy's Biologics Division, which is developing treatments for cancer and autoimmune diseases. The company has also launched the generic version of Amgen's Neupogen, and named it Grafeel. The company has spent more than Rs 44.48 crore ($10 mn) for developing Reditux and within a year of its launch the products have successfully gained 30-35 percent share of the market. Dr Reddy's Reditux is priced at Rs 39,996 for a vial and is almost half the price of Roche's Mabthera. This product is now approved for marketing in India. Pune-based Serum Institute has entered into another agreement with Akorn of the US in 2007 for definitive development and exclusive distribution rights for rabies mAb. As part of the agreement, Serum has agreed to appoint Akorn as the exclusive distributor for rabies mAb. In exchange for Akorn receiving the exclusive marketing and distribution rights of North, Central, and South America, Akorn has agreed to provide Serum funding for product development through milestone payments. Intas Biopharmaceuticals has signed a Memorandum of Understanding (MoU) with Government of Gujarat in 2009 for setting up a separate manufacturing facility for MAbs, a recombinant mammalian platform product. The company will invest Rs 160 crore towards setting up a manufacturing facility at Sanand near Ahmedabad. The facility, fully-dedicated for mAbs, will undertake large-scale manufacturing of the recombinant product with a capacity of 5000L in phases. â€œAs part of its Strategic Research Initiative (SRI), the company is focusing on cloning mAbs and developing proprietary and novel expression systems using different mammalian cell lines,â€? says Dr Mody. These companies apart, Daftary group promoted Bharat Serums and Vaccines and Bangalore-based Avesthagen are some of the other notable companies that have chalked our serious plans for the space. Challenges ahead MAbs are complex protein molecules. In addition to the protein structure, often there is a carbohydrate moiety attached to the molecule. Characterization of such complex molecules is a challenge, this is why, very few companies in India are active in mAbs arena. â€œNot only do you need sophisticated equipment to analyze mAbs, you also need skilled manpower to do this. Since most of these are immune-modulatory in nature, they have complex reactions with the human body. Therefore, we have to determine the biological activity of these molecules using specific cell lines. Performing such bioassays is also a challenging,â€? adds Dr Iyer. Industry experts agree that the mAbs market in India is in its nascent stage. In India, only few players are active in mAbs space. There are many players who have aspirations to enter the space as the next generation of biotech products would be mAbs. However, there are only a handful of companies that have products in the preclinical stage. The reasons are many. â€œIt is difficult to copy human mAbs, which is complex and expensive process. It takes a long time to develop and it needs some vigorous ground work and intensive research that Indian companies are yet to gain mastery,â€? adds Shetty. In addition to this, the Drug Controller General of India (DCGI) is yet to come out with a set of systematic guidelines dedicated especially for mAbs. Companies like Dr Reddy's Labs and Biocon have been the only two companies successful in bringing in products while the remaining are still in the development stage.â€?Shetty says, â€œIt will take some time for India to become a lucrative market for mAbs. In biogenerics, too, the market would take time to pick up. In addition to this, the high costs of investments involved can also be a barrier. â€œMAbs business involves patents and for navigating through these patents requires exceptional skills,â€? adds Dr Mody. Future prospects By 2015 , due to the expected launch of many new therapies such as Denosumab and Teplizumab, the sales of mAbs is expected to reach Rs 3 lakh crore ($67.6 bn), with a CAGR of 13.8 percent between 2008 and 2015. The biotherapeutic market would be dominated with mAbs in next five years as most of the blockbuster molecules are going off-patented. All the pharma majors have mAbs projects in their R&D portfolio. Introduction of newer monoclonal antibodies will greatly expand the market. Globally, the FDA had approved four new mAbs and EMA had approved seven new mAbs in 2009. There were at least six new mAbs under regulatory review, 26 mAbs (32 in 2008) are in phase III and over 100 are in phase II clinical trials. There are more than 150 mAbs molecule awaiting regulatory approval. In addition to this, several promising candidates from companies like Pfizer are in phase III clinical trials. In the recent past, Sanofi-aventis Chris Viehbacher, CEO of Sanofi-aventis, had commented that they had missed the 'boat to biologics' and are in active pursuit of this promising mAbs market. Sanofi-Aventis is converting a factory near Paris into a biotechnology development hub, with its doors wide open to smaller biotech companies looking to partner on projects. The French pharma giant says that the Rs 1,178 crore ($265 mn) venture marks their commitment to ramping up their work on biologics. It is an opportunity for the company to do partnerships with biotechnology and research companies. The investment of nearly Rs 1,183 crore (â‚¬200 mn) will give rise to the first cell culture biotechnology platform of the group to produce mAbs from 2012. On the other hand, within the same time period, experts are cynical as to whether India can match up to global standards given a the huge amount of investments and the complexity that the process involves. â€œI do not see that Indian companies achieving much by 2015 and taking their products globally is but a distant dream,â€? concludes an analyst. Compared to India, China is a big market for mAbs. Some notable companies include Union Stem Cell and Gene Engineering and Biotech pharmaceutical. In a serious effort towards innovation,China is moving towards areas like stem cells, mAbs, cancer and HIV development and vaccines with investments being pumped in both by the Government and foreign sources. India, experts opine needs exactly the same kind of backing if it need to bolster growth rates of the sector in the region. â€œMAbs offer an enormous amount of target specificity that reduces the likelihood of nonspecific, untoward side effects commonly observed with small moleculesâ€? - Dr Rustom Mody, chief scientific officer and director-quality, Intas Biopharmaceuticals Nayantara Som with inputs from Jahanara Parveen ]]> <![CDATA[Diabetes pipeline-Clinical research in progress]]> https://biospectrumindia.com/news/95/1870/diabetes-pipeline-clinical-research-in-progress.html https://biospectrumindia.com/news/95/1870/diabetes-pipeline-clinical-research-in-progress.html Wed, 05 May 2010 11:19:00 +0530 Prof. Lesley Campbell, professor of medicine, director of diabetes services, at Garvan Institute of Medical Research, Australia, is keen on clinical research and her focus has been in the cause of type 2 diabetes, particularly what triggers the insulin resistance and obesity that occurs in 90 percent of people with type 2 diabetes. To study the cause without the confounding influence of hyperglycaemia or dyslipidaemia, she studies healthy close relatives of people with type 2 diabetes—because the disease is under strong genetic influence. So far her institute has published that such people—with a high probability of developing diabetes later in life—show deficiency in a satiety hormone response called Peptide YY (PYY)—while they are still normal weight— which may predispose them to gain weight in later life. “We also see that they have a defect in turning on fat oxidation in response to a fat meal, which may cause the later metabolic abnormalities,” says Prof. Campbell. “Our work shows that the people who are to get diabetes already have a biological  predisposition to weight gain (not just ‘willful overeating’ as is so often said) and in blood and tissue samples we are now able to isolate the mechanisms for the earliest changes contributing to the insulin resistance that characterizes the primary defect of type 2 diabetes (as opposed to type 1 diabetes).” Another area of research for Garvan Institute has been to examine the challenge of the ‘orphan’ disease Prader-Willi Syndrome (PWS): the most commonly known genetic obesity disorder arise due to an imprinting defect on chromosome 15. A project to examine the intense, uncontrolled hunger that disrupts the life of the family and the sufferer of this developmental disorder, sometimes resulting in PWS sufferers needing to live in care situations to restrain their eating. “We have examined the satiety and hunger hormones of volunteer subjects from the Royal Prince Alfred PWS clinic in a very strongly matched way with obese subjects without PWS to tease out any real differences intrinsic to PWS. We have found higher immune activation that may be an intrinsic part of the disease,” says Prof. Campbell. “We have completed a single dose  pilot study of a novel therapeutic agent that is already released for diabetes and may be a potential treatment for PWS against appetite, as no medication is recognized as effective at present. This indicates the need for a longer trial. We are also examining the contributors to the increased cardiovascular risk in PWS subjects and are comparing the risk factors with matched obese and lean volunteers. In collaboration with Prof Herbert Herzog, also from the Garvan Institute, we have commenced a study by producing a mouse model of the disorder—the technology for which came recently—that allows the study of the brain with knockout of the gene and study of the phenotype,” she adds. Garvan has submitted an intravascular ultrasound (IVUS) study of rosiglitazone  post-stenting examining one year results in the coronary arteries of diabetic subjects having stents in another artery. Rosiglitazone has shown improved glycaemic control, lessened inflammation including adiponectin. Dr Reddy’s Pharma, one of India’s top pharmaceutical companies by revenues and sales, announced successful phase III results of its balaglitazone in January 2010. Dr Reddy’s said preclinical studies indicated that besides robust glucose lowering ability, balaglitazone results in lower body fluid accumulation, lower fat accumulation, less heart enlargement and no reduction of bone formation, indicating that balaglitazone may be able to displace the balance between desired and side effects, and thus show a better safety profile than full agonists of PPAR-gamma. Danish diabetes giant, Novo Nordisk, has two new-generation insulin products, Degludec and DegludecPlus—that are intended improve treatment outcomes and provide more convenient insulin therapy with a possibility of fewer injections. Currently in phase III development, the Degludec and DegludecPlus development programs will involve more than 10,000 patients from 39 countries around the world. The trial program for Degludec is known as BEGIN and will involve more than 7,000 patients. Degludec has so far demonstrated an ultra-long duration of action of more than 24 hours, offering the potential of greater dosing flexibility and lower risk of hypoglycaemia. The trial program for DegludecPlus is called BOOST and will recruit over 3,000 patients. DegludecPlus is the first soluble combination of an ultra-long-acting basal insulin with a boost of rapid-acting insulin (NovoRapid). Novo Nordisk is also focusing on the development of oral protein formulations for both insulin and GLP-1 for the treatment of diabetes. Since data from Drug Abuse Warning Network (DAWN) database and elsewhere show that injections continue to be a barrier to insulin initiation among physicians treating diabetes, Novo Nordisk believes that the introduction of a safe and effective oral insulin (and GLP-1) product to the market could lead to earlier use of insulin in diabetes treatment, and hence, the potential for better treatment outcomes and reduced risk of disease-related complications in people with diabetes all over the world. In an interview with BioSpectrum, Jesper Hoiland, senior vice president of international operations, Novo Nordisk, says a oral insulin pill was introduced in Germany in December 2009 and is in a phase I clinical trial. “In the long run, within eight to 10 years we can see the diabetes pill becoming available in the markets.” According to him the oral insulin looks fine in clinical trials done so far. The power of prevention Prof. Campbell of Garvan Institute says no prevention trial of type 1 diabetes is known to be successful. Insulin therapy in type 1 diabetes has been improved by insulin analogues, usually treated with background dept insulin and short-acting analogue with each meal, but young people in particular are using insulin pump therapy. Continuous glucose monitoring is not commonly used. Transplants are offered only to those with complications such as renal failure or severe hypoglycemia. For many people, type 2 diabetes can be managed or prevented by a healthy diet and regular exercise. Many people worldwide do not know they have diabetes, and many of those who do know are in poor control of their diabetes.  Lifestyle change is still the first option for the treatment of type 2 diabetes, experts say that treating diabetes at an early stage improves quality of life, but is cost-effective, especially if it prevents hospitalization. There is conclusive evidence that good control of blood glucose levels can substantially reduce the risk of developing complications in all types of diabetes. Financial burden Diabetes imposes a large economic burden on the individual, national healthcare system and economy. Healthcare expenditures on diabetes are expected to account for 11.6 percent of the total healthcare expenditure in the world in 2010. Most countries will spend between five and 13 percent of their total healthcare dollars on diabetes. According to IDF Diabetes Atlas,  estimated global healthcare expenditures to treat and prevent diabetes and its complications are expected to total at least Rs 16,71 lakh crore ($376 bn) in 2010. By 2030, this number is projected to exceed Rs 21.77 lakh crore ($490 bn). Expressed in International Dollars (ID), which corrects for differences in purchasing power, estimated global expenditures on diabetes will be at least ID418 bn in 2010, and at least ID561 bn in 2030. An estimated average of $703 (ID878) per person will be spent on diabetes in 2010 globally. There exist a large disparity in healthcare spending on diabetes between regions and countries. More than 80 percent of the estimated global expenditures on diabetes are made in the world’s economically richest countries, not in the low- and middle-income countries where over 70 percent of people suffer from diabetes. The US, is projected to spend Rs 8.80 lakh crore ($198 bn) or 52.7 percent of global expenditure in 2010, while India, the country with the second largest population of people living with diabetes, is expected to spend an estimated Rs 12,444 crore ($2.8 bn), or less than one percent of the global total. An estimated average of Rs 3.28 lakh ($7,383) per person with diabetes is expected to be spent on diabetes-related care in the US but less than Rs 444 ($10) per person will be spent in Burundi, Côte d’Ivoire and Myanmar in 2010. The World Health Organization (WHO) predicted net losses in national income from diabetes and cardiovascular disease of ID557.7 bn in China, ID303.2 bn in the Russian Federation, ID236.6 bn in India, ID49.2 bn in Brazil and ID2.5 bn in Tanzania (2005 ID), between 2005 and 2015. The largest economic burden, therefore, is the monetary value associated with disability and loss of life as a result of the disease itself and its related complications. This economic burden, however, can be reduced by implementing many inexpensive, easy-to-use interventions, most of which are cost-effective or cost-saving, even in the poorest countries. Unraveling type 1 diabetes Type 1 diabetes is increasing three percent per annum globally, according to Eurodiab and WHO  registry. Several factors are thought to play a part (including increasing recognition of slow onset, non-classical type 1 diabetes in children and LADA, late onset type 1 diabetes) in older adults. The possible  environmental factors include infectious exposure, vitamin D deficiency, less exercise and more obesity. Scientists at The Scripps Research Institute in the US recently unraveled the 40 year old mystery of how certain genetic mutations lead to type 1 diabetes. The researchers says their findings could lead to novel therapies for type 1 diabetes and other autoimmune diseases. Three genetic variations in particular (HLA-DQ2, HLA-DQ8, and HLA-DR0405)-all located in the region of the genome called human leukocyte antigen (HLA) are known to increase risk of diabetes. These three genes encode molecules that present peptides to the body’s T cells, which determine whether the peptide being presented is dangerous and needs to be eliminated from the body, as in the case of foreign invaders such as bacteria or viruses-or whether the peptide is ‘self’, part of the host and something the immune system needs to leave alone. However, in the context of type 1 diabetes, T cells aggressively attack the body’s own cells. While type 2 is responsible for most of the increase in diabetes. HEALTH EXPENDITURE FOR DIABETES IN 2010-APAC Country/Territory 2010 Population (20-79 years) (000’s) Mean health expenditure(US$) per person with diabetes Australia 15127.7 3781 China 964301.6 115 China, Hong Kong 5732.5 N/A China, Macau 382.9 N/A Indonesia 152827.7 41 Japan 96665.9 3125 South Korea 36602.9 1255 Malaysia 16919.9 325 New Zealand 2952.4 2965 Singapore 3433.2 1129 Taiwan 14221.6 N/A Thailand 45924.4 144 India 713498.4 55 Philippines 50999.8 61 DIABETES RESEARCH PIPELINE BIOCON IN -105 (Oral Insulin) Subcutaneous insulin is very effective in the treatment of diabetes but its prescription is generally delayed due to inconvenience of needle usage and potential hypoglycemia (caused by excess insulinization). In contrast, Oral insulin (ie. Insulin in tablet form) is simple and painless to administer. Additionally, it is delivered through the portal vein, mimicking the natural physiology of the body. If successful in the clinic, oral insulin could become a very important therapy for intervention in earlier stages of diabetes. Biocon is developing IN -105, a conjugated insulin molecule that is orally delivered and targeted towards the treatment of diabetes. In 2009, the company has made significant progress along its development life cycle. Biocon’s R&D group has successfully developed a tablet for oral delivery of IN -105, its formulation carefully selected to give consistent absorption and glucodynamic (glucose-lowering) effect. In the clinic, this molecule has completed phase I and initial dose-range-finding phase II trials. TAKEDA Insulin pipeline SYR-322 is a promising pipeline drug for the treatment of diabetes, following Takeda’s core product Actos. SYR-322, which acts as a DPP-4 inhibitor, was discovered by Takeda San Diego (TSD) as a therapeutic agent for type 2 diabetes. Takeda is also working to develop a product combining SYR-322 with Actos. Short-acting insulin secretagogue diabetes concomitant therapy with thiazolidinediones. Insulin sensitizer Diabetes Concomitant therapy with thiazolidinediones Diabetes Concomitant therapy with insulin Diabetes Concomitant therapy with biguanides Diabetes Fixed dose combination with extended-release metformin Diabetes Fixed dose combination with metformin Diabetes Fixed dose combination with glimepiride Diabetes Orally disintegrating tablet Alpha-glucosidase inhibitor Prevention of the onset of type 2 diabetes with impaired glucose tolerance (IGT) DPP-4 inhibitor DPP-4 inhibitor Diabetes Diabetes Fixed dose combination with Actos Diabetes Concomitant therapy with thiazolidinediones Diabetes Fixed dose combination with metformin Neurotrophic factor production accelerator Diabetic neuropathy Glucose-dependent insulin secretagogue Sanjeev Jain in Bangalore ]]> <![CDATA[Pursuit of excellence in cancer research]]> https://biospectrumindia.com/news/95/2811/pursuit-of-excellence-in-cancer-research.html https://biospectrumindia.com/news/95/2811/pursuit-of-excellence-in-cancer-research.html Wed, 05 May 2010 11:12:00 +0530 Dr Manu Jaggi has spent over 20 years in cancer drug discovery and preclinical drug development. He has been instrumental in developing a novel nanoparticle-based drug delivery system. Early years Back in the days, Dr Jaggi spent his formative years developing a novel drug delivery system at New Delhi-based Institute of Nuclear Medicine (INMAS) and Institute of Genomics and Integrated Center for Biotechnology (earlier called as the Center for Biochemical Technology (CBT)) where he worked as a research scholar working on Cancer treatments. He gained his masters degree in pharmacy from the Delhi University and started working for National Institute of Immunology (NII), New Delhi. AT NII, he got an opportunity to learn and understand cell biology and molecular mechanisms underlying cancer, which is one of the most dreaded diseases. During his doctorate, he proposed and validated a hypothesis that neuropeptides work as growth factors in adenocarcinomas, which is now a widely accepted finding. His professional education in pharmaceutics helped in the development of a peptide-based anti-cancer drug, DRF 7295, which went through a long journey and successfully completed phase II clinical development. Research initiatives After joining DRF in 1994 as a senior research scientist, he set up a state-of-art anti-cancer laboratory and started drug discovery and development in oncology. His team developed and standardized a panel of in vitro and in vivo screening assays for cancer and specialized in hit identification and pre-IND candidate selection. In 1998, they started working on a novel nanotechnology-based delivery system and made a significant contribution in the early and late preclinical development of a nanoparticle based drug called Nanoxel, which was launched in India in January 2007. Nanoxel is a first polymeric nanoparticle-based drug delivery system in the world. Further in this direction, his team has co-developed six to eight anti-cancer leads belonging to peptide, small organic synthetic molecules and phytochemical class of molecules. DRF turned into a full-fledged contract research organization (CRO) and started offering services in preclinical domain. â€œWe differentiated ourselves from other CROs by providing customized high-end services in cell biology and pharmacology besides the complete collection of toxicology ADME-PK, and analytical services.â€? The experienced preclinical team that had developed its own pipeline in the past quickly adapted to this new business model. Innovation front Dr Jaggi believes that the vision of Dr Anand C Burman, chairman of DRF, and his relentless pursuit of excellence in cancer research is responsible for the movement of the company to the position of a leading oncology company in India. He says, â€œIn 2008, Dr Burman once again saw the unmet need in preclinical outsourcing and focused the efforts of DRF in that direction.â€? On talent, Dr Jaggi says, â€œIt was the free hand given by Ajay K Vij, CEO of Althea Lifesciences, the contract research arm of DRF, who has always encouraged talent pool. We set up an innovation research team, which has the mandate to develop novel and unique models required to complete the preclinical development of specific molecules in the pipeline of our clients. This has enabled us to have large multinationals clients from all parts of the world.â€? Currently as the Director of Dabur Research Foundation, Dr Jaggi leads a team of about 40 scientists and is backed by Dr Anu T Singh who leads the preclinical R&D team. While appreciating her efforts he says, â€œDr Singh and her team developed several cell biology-based efficacy models for several diseases. These offer value to companies that are looking for a proof of concept evaluation of their compounds to enable critical go/no go decisions in a cost-effective fashion.â€? Fully content with his research achievements, Dr Jaggi says, â€œMy research journey starting from the National Institute of Immunology to Dabur Research Foundation, where I presently work has been professionally very satisfying and fulfilling.â€? Life and family A workaholic that he is, Dr Jaggi is a family man. â€œMy weekends are completely for my family. I love traveling and make it a point to go for a short vacation with my family at least twice a year. I love collecting souvenirs from all over the world and also keep a close watch on new gadgets that help me stay organized and in tune with the times and I usually don't wait too long before buying them.â€? Dr Jaggi belongs to a family of doctors and researchers and lives in a joint-family setup with his parents, brother and their families. While talking about his family, he says, â€œThis has worked beautifully for us as it provides a sense of security without compromising on the independence. Right from my childhood scientific discussions were encouraged at home. While my father and brother are both renowned doctors, my wife is a teacher. I have a daughter studying in class XI.â€? Feeling indebted to his father Prof. (Dr) OP Jaggi for his encouragement, he also remembers the role of Prof. DS Kothari, Prof. GP Talwar and Prof. TAV. Subramaniam; whom he considers his mentors and guides in encouraging him in his formative years as a scientist. More on Dr Manu Jaggi ■ Dr Jaggi holds a doctorate in cancer biology from the National Institute of Immunology, New Delhi, and is a post-graduate in pharmaceutical sciences (Gold Medalist). ■ He holds the position of Director of R&D at Dabur Research Foundation (DRF) since 2008. Previously he was the head of preclinical research at DRF. He set up a state-of-art anti-cancer laboratory in 1994 at DRF. ■ He has developed and standardized a panel of in vitro and in vivo screening assays for cancer and specializes in hit identification to pre-IND candidate selection. He has proposed and validated a hypothesis that neuropeptides work as growth factors in adenocarcinomas, which is now a widely accepted finding. ■ He has been fairly active in patenting and publishing his work. He holds 27 US patents, more than 70 in rest of the world and even more in India. He has also published and presented more than 60 research papers in peer-reviewed journals. ■ At DRF, Dr Jaggi has trained more than 200 biotechnology post-graduates students in modern techniques of drug discovery and has also guided several PhD students. He holds memberships in several scientific committees and has attended and presented at many international and Indian conferences and meetings. INTERVIEW â€œIn targeted therapeutics lies the future of cancer treatmentâ€? - Dr Manu Jaggi, director, DRF, Uttar Pradesh In an interview with BioSpectrum, Dr Manu Jaggi speaks about the cancer research, challenges before biotech industry and host of other issues Q What are your views on the latest trends in cancer research? Recent years have witnessed new discoveries on diverse molecular and biological changes underlying cancer development and progression. These insights are changing our understanding of the complex pathways that regulate cancer cell biology, the interactions of tumors with their microenvironment, and the mechanisms that normally restrain tumorigenesis. Importantly, researchers today are translating these findings into novel approaches towards cancer diagnosis, prognosis and therapies. In my opinion, the future of cancer treatment lies in the targeted therapeutics. This approach uses genetically engineered cell lines and organisms that help to locate and attack defective molecules. Using gene knockdowns, signal transduction knowledge, and more, today's researchers are working towards treatment modalities that fight cancer. As a result, I strongly believe that targeted therapeutics is undergoing development at a fast pace. The next decade will bring a continued focus on access to new cancer therapeutics in countries with aging populations such as the US, Europe and Japan, as well as in countries with emerging economies such as India and China. The pharmaceutical and biotechnology industries are dedicating resources for developing innovative treatments, but more assistance by government is needed to get products to market in a timely fashion. In terms of research activities of Dabur Research Foundation, for many years our focus has been towards understanding the mechanism that turns a normal cell into a cancerous cell. We have developed unique cell signaling strategies that enables us to screen potential anti-cancer molecules against specific targets. The 'Cell MAP' (Mechanism of Action Profiling) technology platform developed by DRF profiles novel molecules as well as modified formulations of anti-cancer drugs for their putative mechanism of action in target cancers. The combination of drug uptake studies and signal transduction approaches elucidate the underlying mechanism of action of the candidate molecules. In vitro and in vivo assessment of effects on neovascularization and programmed cell death are also investigated to critically assess the anti-cancer potential of the molecules under investigation. The strategies encompassing Cell MAP are adaptable to molecules for other therapeutic areas as well. Apart from that, to the best of my knowledge, we are the first to develop a battery of models that enable identification of molecules with potential chemotherapy induced toxicities. The SAFETY (Screens Available for Frequently Encountered Toxicities) screen developed at DRF is designed specifically to monitor clinical toxicities frequently seen with cytotoxics in the clinical practice. The screen investigates toxicities that are typically not detected in conventional safety assessment strategies. The SAFETY screen includes preclinical models for assessment of cardiotoxicity, gastrointestinal toxicity, alopecia, neutropenia and peripheral neuropathy. Q What are the challenges faced by the biotech sector in India? India, today, holds a small share of the global biotech market, but it has all the capabilities to become a dominant player. India has the strength and capabilities in this industry, and a definite advantage to forge ahead and become the chosen location for many biotech companies looking for large markets and low cost qualified manpower. With numerous comparative advantages in terms of R&D facilities, knowledge, skills, and cost effectiveness, the biotechnology industry in India has immense potential to emerge as a global key player. Further, India provides an ideal setting for manufacturing activities and high-level biotechnology research programs. With the initiatives taken by the government, Indian biotechnology is poised for a tremendous growth. While the key challenges faced by the industry are the social and environmental implications. Biotechnology has certainly opened several effective approaches to disease treatment and enhanced the prospect of further advances in treatment for the benefit of patients. However, these advantages have come at a price, and biopharmaceuticals, partly due to their complex manufacturing and handling, are comparatively costly. The cost-effectiveness of the products and offering them at an affordable cost to patients remains a major challenge for the industry. The other challenge before the government is to change the general perception among common man that all biotech products pose an environmental risk to the population. I believe that well-designed preclinical studies addressing the efficacy and safety of the biotech products will certainly aid in bringing novel biotechnology-based products to the market Q What are the future prospects of the biotech sector? Biotechnology will help to develop a large number of genetically improved plant varieties in India. There has already been a spurt of activities in this direction. The development of molecular biology will extend the scope of diagnostic kits and vaccines for major diseases and thereby makes health care system more efficient and cheaper. Genetic counseling clinics, molecular probes, and fingerprinting techniques will all be used in due course to solve the genetic disorders in people. The establishment of ex situ gene banks to conserve valuable germplasm and diversity, and a large number of repositories, referral centers for animals, plants, and microorganisms should be given a priority. Information technology, where India is already a leader, together with biotechnology is likely to become a major economic force. To achieve the goal of self-reliance in this field, India requires a strong educational and scientific base. Rahul Koul in New Delhi ]]> <![CDATA[Contract research in India: Cost factors and regulatory issues]]> https://biospectrumindia.com/news/95/1788/contract-research-in-india-cost-factors-and-regulatory-issues.html https://biospectrumindia.com/news/95/1788/contract-research-in-india-cost-factors-and-regulatory-issues.html Wed, 05 May 2010 11:11:00 +0530 Contract research came to India in the 1990s. A number of key developments came together around the turn of the century to make it all possible. First, there was the Indian Patents (Amendment) Act of 2005 that forced Indian pharmaceutical companies to invest in innovation. This created the initial staffing pool and generated a local market for research personnel. Then there were the implications of the process of harmonization of research regulations led by the International Conference on Harmonization (ICH) since 1990 that spelt out common regulatory requirements for countries covering 85 percent of the world's pharmaceutical markets, making it mandatory for regulatory authorities in these countries to accept research results from anywhere in the world fulfilled its requirements. And finally there was the communications revolution that swept the world making real-time collaboration across geographies a reality. All this led to significant growth in research activity in the country, and contract research as an off-shoot. Contract research took on a life of its own after the year 2000. Companies were set up to provide services in the drug discovery space with collaborative research models. Large and small drug development service companies sprung up all over the place with clinical pharmacology beds, bioanalytical services, compound scale-up and clinical supplies units, clinical trial management teams, and data management, biostatistics and medical writing offerings. The growth seemed rapid and remarkable, yet its impact on worldwide pharmaceutical research remained marginal. The world contract research market is estimated to be worth Rs 1.15 lakh crore ($26 bn) in 2010 while estimates of India's share do not exceed two percent at this time. Clearly, the potential for India is much greater. Competition from China India competes closely with China, and while in the initial years of globalization of pharmaceutical research it seemed that India had the advantages such as booming generic formulations industry, English-speaking workforce and western-style medicine. In recent years, China has pulled ahead with better infrastructure, more supportive regulations and incentives, and a much faster growing pharmaceutical market that demands and gets investments from overseas. The big pharmaceutical companies have, over the last 10 years, invested much more heavily in R&D in China than in India. In 2009, we have seen some large CROs following suit. India seems to be losing to China on cost and pricing. With a reputation for low prices, international sponsors seem to expect services to cost less in India than in China. On the other hand, costs are continuously going up, with inflation now into the double digits while the Rupee seems to be strengthening in contrast to the artificially weak exchange rate for the Yuan. And payroll costs are growing at double digits too, with salary increase being higher here than anywhere else in Asia. Tax and other incentives for contract research in India fall far short of compensating to these disadvantages, leave alone matching what other countries in the region have on offer to attract contract research spending by global sponsors. Regulatory issues When one thinks of the state of drug development regulation in India, it seems almost as if the government is deliberate in throwing the match away. Animal rights bureaucracy has made it almost impossible for the country to grow in the area of animal testing despite some easing in recent years. Yet the length and types of animal studies that need to be completed to get permission for human trials are much more demanding in India than anywhere else in the world. Consequently, if you have discovered a promising new medicine you would be forced to go abroad to do the first-in-human studies. And it would be a good thing too, since there is no expertise in bench-to-bedside translational medicine in the country as a result of a long-existing ban on phase I studies. When it comes to phase II and III studies, many innovative biotechs and small entrepreneurs in Europe and the US are interested in contracting to Indian CROs, since India has an advantages of patient availability and cost reduction. But our regulators will not permit it unless at least half the patients are to be recruited abroad. This beats the very purpose of coming to India. Yet one cannot blame the regulators for this â€“ the government support provided to the office of the Drugs Controller General is so poor that the regulator is heavily dependent on regulatory assessments done by foreign regulatory bodies and is diffident in approving anything that has not been reviewed abroad. Fortunately, Indian entrepreneurship manages to survive. Government regulation has a much smaller impact on areas such as discovery research, informatics, and allied services in clinical trials such as data management, biostatistics, pharmacovigilance and medical writing. Constraints in these areas mainly relate to the cost, quality and availability of a qualified workforce. The future Institutions in the country that can provide quality education at the cutting edge of scientific research are very few-but the news that education will be opened up to international investment provides a glimmer of hope. The key to a long-term future in these areas depends on the availability of a large pool of scientific manpower trained in various disciplines that contribute to the science of drug discovery and development. The future of contract pharmaceutical research in India, is related to other infrastructure facilities available in the country. General developments such as infrastructure, education, and the economy will play a key role, as much as more specific issues like the development of regulation and incentives for medicinal research. We may have to rejoice in patchy successes in some areas of the domain and reconcile to mediocrity in others. Getting to a leading position in drug discovery and development will require much more than that-a focused national approach and clear policy directives from the administration. Unfortunately, there are no positive signals in that direction. Dr Shoibal Mukherjee is senior vice president and heads clinical development, GVK Bio, Hyderabad. ]]> <![CDATA[CSMCRI to develop more efficient jatropha plants for General Motors]]> https://biospectrumindia.com/news/95/5955/csmcri-to-develop-more-efficient-jatropha-plants-for-general-motors.html https://biospectrumindia.com/news/95/5955/csmcri-to-develop-more-efficient-jatropha-plants-for-general-motors.html Wed, 05 May 2010 11:07:00 +0530 An Indian research laboratory, the Central Salt and Marine Chemicals Research Institute (CSMCRI), based in Bhavnagar, Gujarat, will start a 5-year, Rs 4.88 crore ($1.1 mn) research project to develop new varieties of biofuel bearing shrub, jatropha curcas L, for large scale plantation in the US. CSMCRI is one of the constituent laboratories of the publicly-funded Council of Scientific and Industrial Research (CSIR) network. The project is being funded by the world's leading automobile manufacturer, General Motors (GM) as part of its green initiatives. According to GM India's President and MD, Karl Sym, CSMCRI will grow jatropha varieties in 83 hectares of land for research purposes under the agreement. While researchers at CSMCRI will try to develop frost-tolerant varieties and also attempt to increase biofuel conversion efficiency of the plant. CSMCRI scientists will modify the plant to make it withstand severe climatic conditions. These crops will be developed further for frost tolerance in US research institutes by General Motors. Frost tolerance has emerged as one of the requirements if jatropha has to be commercially cultivated in the southern part of the US and Latin America. Jatropha curcas plant is a native plant of Brazil. So far, all attempts to grow jatropha curcas on commercial scale have not succeeded due to the havoc wreaked by frost on this otherwise hardy crop. If CSMCRI scientist manages to genetically alter the crop to make it frost tolerant, it will be a major scientific breakthrough. To reduce pressure on biofuel crops replacing food crops, government policies restrict cultivation of jatropha to degraded wastelands. Hence CSMCRI scientists also try to make the plants adopt better to very harsh environmental conditions that prevail in many parts of the country. Pushpito Ghosh, director of CSMCRI, said, â€œScientists will also try to prepare a full environmental life cycle of jatropha. The results will provide useful scientific data in the backdrop of severe criticism of jatropha and other biofuel plants being not very efficient in terms of improving the environmental conditions.â€? Jatropha is a variety of shrubs and trees belonging to the genus Euphorbiaceae. There are over 175 varieties of this succulent plant that grows widely throughout the tropics and in parts of North America, Caribbean and Africa. The oil is extracted from the non-edible seeds and has been used successfully as biofuels in automobiles. In fact, GM itself ran some of its vehicles on experimental basis for over 15,000 kilometers on biodiesel and the energy efficiency has been found to be very good. This has prompted the company to develop biodiesel-bearing plants in as many areas as possible. Efficient agronomic practices for jatropha have not been developed so far on the lines of edible oil plants like canola, rapeseed. Agronomic practices become important as the crop is touted as suitable for arid and marginal lands. Experts have found that confining jatropha and other biofuel crops to marginal lands is restricting the scope for increasing the crop's oil yields that is crucial to make biodiesel production economical and to make it a strong alternative biofuel. BS Bureau OSDD releases the C2D research findings The Open Source Drug Discovery (OSDD) initiative of CSIR has released the results of its 'Connect 2 Decode' (C2D) project to re-annotate the biological and genetic information related to the Mycobacterium tuberculosis (Mtb) genome, in New Delhi. C2D's findings may help to reveal the previously undiscovered details of tuberculosis (TB); resulting in developing TB drugs in India and other developing countries. This is the first time that a comprehensive mapping of the Mtb genome has been made publicly available. The Mtb map has been hosted on a web portal (www.osdd.net) custom-developed by Infosys and uses an emerging format (Web 3.0) that allows users to get better search results. C2D demonstrates the power of people to connect through the Internet, particularly young people, and accomplish complex research tasks. According to WHO, 17 lakh people die annually from TB. The emergence of multidrug-resistant TB (MDR-TB) and extensively drug-resistant TB (XDR-TB), where patients cannot be treated with first-line drugs (or, in the case of XDR-TB, more expensive second-line drugs), further underscores the need for a new generation of TB drugs. Under the C2D project, researchers and students pooled their time and skills using online tools to provide insights into 4,000 genes of the deadly pathogens. As a first-of-its-kind government initiative, the OSDD was launched in September 2008 by CSIR. It is a Rs 146 crore collaborative research effort that focuses primarily on TB. Its objective is to accelerate R&D for TB drugs. With a global community of nearly 3,000 members from 74 countries, the OSDD brings together scientists, doctors, students, policy experts, software professionals and others to work on TB research. ]]> <![CDATA[Indian surgeon wins international Spine Award]]> https://biospectrumindia.com/news/95/1378/indian-surgeon-wins-international-spine-award.html https://biospectrumindia.com/news/95/1378/indian-surgeon-wins-international-spine-award.html Wed, 05 May 2010 11:02:00 +0530 Spine surgeon Dr J Naresh Babu of Mediciti Hospitals, Hyderabad, has been honored with the prestigious Asia Pacific Orthopedic Association (APOA) International Spine Award for 2010. He shares the honor with two other spine surgeons from Japan and Hong Kong. APOA is an organization of orthopedic surgeons from the 17 countries of the Asia Pacific region. The objective of APOA is to advance research in the field of orthopedic surgery. The APOA Spine Award is given once in two years to the significant research and clinical work done in the field of spine surgery. Dr Babu received this year’s award for his pioneering work on treating low back pain with minimal invasive surgery. In contrary to the traditional open surgery which involves cutting the muscles and bones, he devised a new surgical technique and approach where in the surgery including placing the screws in to the bone could be carried out without cutting the muscles and bone. Dr Ekkundi becomes R&D head of Hikal Hikal, a contract manufacturer for global life sciences and specialty chemicals companies, has appointed Dr Vadiraj Ekkundi as the head of its R&D facility in Bangalore. Dr Ekkundi comes with over 26 years of experience in the field of research and development activities. His experience encompasses a mix of scientific, technical as well as managerial roles. He has occupied various top level positions in leading multinational companies such as Hindustan Lever, Wyeth Laboratories, Atul Products, and Ciba. ]]> <![CDATA[Indian biotech saw 26% growth in 2009]]> https://biospectrumindia.com/news/95/1528/indian-biotech-saw-26-growth-in-2009.html https://biospectrumindia.com/news/95/1528/indian-biotech-saw-26-growth-in-2009.html Wed, 05 May 2010 10:59:00 +0530 Indian biotech industry is booming and in 2009 it grew at a CAGR of 26.5 percent and generated total revenues of Rs 10,682 crore ($2.4 bn) according to Research and Markets, an independent market research resource. The report titled 'Booming Biotech Market in India' credited the boom to a large pool of scientific talent, world-class information technology industry, and vibrant pharmaceutical sector. The report said the industry has been able to survive successfully amid the global financial turmoil. Government initiatives, like setting up of more biotech parks and encouragement to public-private-partnerships, provided cushion to the biotech industry against tough economic conditions of recession. The year-on-year growth of the biotech market is expected to accelerate in near future due to high demand for vaccines, CROs, biopesticides, biofertilizers, biodiesel and biotherapeutics in India as well as at the global level. The research has found that the biopharma segment constitutes a major part of the total biotech market. It has experienced consistent rise in revenue and the trend is likely to continue in future as well. The overall biotech market will remain buoyant despite the recent economic downturn. The baseline for optimistic future projection of the market is pouring of investments to promote research and support entrepreneurship in the emerging segments. TERI, Deakin to open bionanotech center The Energy and Resources Institute of India (TERI) has inked an MoU with Deakin University, Australia, to establish a new center to tackle the issues related to food and water security, and healthcare. The MoU was signed by the Deakin University Vice Chancellor, Sally Walker and TERI's Executive Director, Dr Leena Srivastava in the presence of India's Minister for Education, Kapil Sibal and the Deputy Prime Minister of Australia, Julia Gillard as part of Minister Sibal's diplomatic visit to Australia. Dr Aloka Adolheya, currently the director of TERI's Biotechnology and Bioresources Center (BBC) and nominated director of the new center said, â€œOur new Bionanotechnology Center has the potential to make significant contributions to solving critical problems faced by India and Australia. It is imperative to adopt new emerging technologies to meet challenges like healthcare, water and food security.â€? The new center is envisaged to have approximately 70 researchers, including 50 PhD students enrolled at Deakin and co-supervised by Deakin and TERI staff. It will also function as a hub for the Deakin India Research Initiative (DIRI) launched earlier this year. This involves up to a further 50 PhD students representing Indian industries or with other research partners again co-supervised by leading researchers in India and Australia. The center is perceived to emerge as a unique conglomerate of researchers from Deakin's ITRI, who bring excellence and expertise in design and characterization of novel nanomaterials and TERI researchers from BBC who bring a wealth of experience in biotech applications in pharmacology, food, agriculture and environmental areas. Avesthagen, Inno tie up for biosimilars Avesthagen has commenced the manufacturing operations of two of its biosimilars at Inno Biologic's Putra Nilai facilities in Malaysia. The first product for anemia, AVDESP has already completed preclinicals and is ready for cGMP manufacturing for conducting clinical trials in India. The second biosimilar for auto-immune disorders, AVENT, will also be produced at the Inno Biologics facility. Avesthagen has a pipeline of eight biosimilars of which four are in advanced stages of development. DST initiates CV Raman Fellowship The Department of Science and Technology, Government of India, has initiated CV Raman International Fellowship for African Researchers under its science and technology initiative. This prestigious fellowship is aimed at strengthening the bond between India and African nations through science and technology collaboration. This fellowship is a follow up action of the new science and technology initiative for African countries announced at the highest level during the India-Africa Forum Summit in April 2008. India introduces KVK e-linkage network Union Agriculture Minister Sharad Pawar has  inaugurated the e-Linkage Network Operation Center at Indian Council of Agricultural Research (ICAR) headquarters in New Delhi. The e-linkage facility provided to 192 Krishi Vigyan Kendras (KVKs) and all the eight zonal project directorates, is part of the process of strengthening the network of 571 remotely located KVKs in the country. This facility will also be extended to another 91 KVKs by the end of 2010. Biocon buys 49% stake of BBPL from CIMAB Biocon has acquired 49 percent stake in its joint venture Biocon Biopharmaceuticals (BBPL) from Cuba's CIMAB. CIMAB is Biocon's partner in Cuba and the partners make medicines based on monoclonal antibodies. Under the business restructuring plan, Biocon will buy CIMAB's 49 percent stake and will make BBPL a wholly-owned subsidiary of Biocon. This deal allows both the partners to focus on the joint development of novel biologics-T1h (Anti-CD6 Monoclonal Antibody), which has just entered phase III clinical trials in psoriasis. BBPL will continue to provide manufacturing support for all partnered programs between CIMAB and Biocon. The two partners will jointly work towards development of T1h for global markets and promote BIOMab and ERYPRO in India and elsewhere. Kiran Mazumdar-Shaw, CMD of Biocon, said, â€œThis move opens a new chapter in our partnership with CIMAB. We see T1h as a unique global opportunity that has the potential of being a 'best in class' therapy for a range of auto-immune diseases like psoriasis, rheumatoid arthritis, multiple sclerosis and diabetesâ€?. Summit Partners invests in Krishidhan Seeds Summit Partners, the growth equity investor, has announced the completion of its investment of Rs 133 crore in Krishidhan Seeds Limited (KSL). The minority investment will be utilized for R&D, technology and product-related acquisitions, international expansion, and company infrastructure. KSL reported consolidated revenues of Rs 279 crore for the year ended September 2009 and is on track to generate more than Rs 400 crore for the current financial year.   Sushil Karwa, managing director of Krishidhan Seeds, said, â€œThe Summit team demonstrated a genuine understanding of our business dynamics, the market place, and opportunities for our ongoing success. The Krishidhan team is excited to partner with Summit to achieve the next phase of development for our company.â€? Scott Collins, managing director of Summit Partners, said, â€œIndia's strong entrepreneurial tradition, combined with a fast-growing economy, means there are many companies that can benefit from Summit's capital investment, strategic advice and industry expertise. Krishidhan Seeds is a great example of this. Building on our experience in the US and Europe, we look forward to all of our future investments in India.â€? Amit Chaturvedy from Summit Partners will become a director on the company's board of directors effective immediately and Vinay Kashyap from Summit Partners will become a board observer. Prakruthik launches nanotech capsules Nanotechnology-based preventive healthcare company, Prakruthik Health Care launched its first product, En-Tube capsules, for intracorporeal detoxification through nanotechnology. En-Tube is a combination of highly purified, activated, nano svarjika (mineral) and Plantago Ovata Husk (herb). It will provide the necessary internal cleansing that is required to keep one fit and healthy. The capsules are made available over-the-counter and are preventive health supplement that can be used by people between 12-70 years. Alvogen opens CRO, API office in India Alvogen, the US-based generic pharmaceuticals company, has expanded its operations in India, by establishing a clinical research organization (CRO) and an API sourcing office in Bangalore. The CRO will specialize in the management of clinical trials and offer clinical research services to Alvogen and third parties. The sourcing office further strengthens Alvogen's relationships with Indian suppliers for raw materials. ICAR allows open access to its journals Indian Council Of Agricultural Research (ICAR) has decided to allow open access to its research journals online. The journals namely, Indian Journal of Agricultural Sciences and Indian Journal of Animal Sciences are published monthly by ICAR. The journals are accessible from the ICAR website from March 2010 issue onwards and will be available globally. This step is expected to benefit the large number of students, researchers and farmers who earlier had to pay for getting information. ]]> <![CDATA[Platform to build partnerships]]> https://biospectrumindia.com/news/95/3801/platform-to-build-partnerships.html https://biospectrumindia.com/news/95/3801/platform-to-build-partnerships.html Wed, 05 May 2010 10:56:00 +0530 Bio International Convention is expected to attract industry leaders from world’s top biopharma companies. The event is expected to offer one of the biggest platforms to share ideas, experiences, insights and best practices on biotech innovations that help to solve some of the biggest global challenges such as fighting disease and improving health, feeding growing populations and meeting the increased world demand for energy. Highlights of the event The event features keynote addresses and sessions from policymakers, scientists, CEOs and celebrities. Keynote luncheon and addresses by renowned people from all around the world are the highlights of the event. Regina Benjamin, US Surgeon General delivers a keynote address on the Diversity in Biotechnology Summit on May 3, 2010, which is also the opening day of the convention. The convention also features the Bio Business Forum (One-on-One Partnering); hundreds of sessions covering biotech industry trends, policy issues and technological innovations; and the world’s largest biotechnology exhibition—the Bio Exhibition. The convention also includes various sessions on topics related to biotech and biopharma industries. A conference on biotech education, various sessions on translational research, academia, intellectual property rights, leadership summit, entrepreneurship in biotechnology and lot of other related issues, are also part of the convention. Over 1,900 companies are expected to participate in the business forum and it has been reported that over 6,000 meetings have been already scheduled during the event, which in itself, is a record. How it came about? The genesis of the convention event dates back to 1987, when the Association of Biotechnology Companies hosted an international conference in Washington, US, which exceeded the expectations with a participation of 155 attendees. Since then, growth has been steady—attendance hit 1,400 in 1993, when Bio was formed with representatives from 68 countries the participation exceeded 22,000 in 2007. In 2007, 2008, and 2009, Tradeshow Week (TSW) named the Bio International Convention as one of the Fastest 50, a list of the fastest-growing trade shows. TSW selected the Fastest 50 based on 50 percent total net square footage growth and 50 percent net growth between 2004 and 2008. In 2009, the Bio International Convention won the award for the fastest-growing convention owned by a not-for-profit trade association. ]]> <![CDATA[Genuity SmartStax corn: An amazing advancement in GE crop]]> https://biospectrumindia.com/news/95/7527/genuity-smartstax-corn-an-amazing-advancement-in-ge-crop.html https://biospectrumindia.com/news/95/7527/genuity-smartstax-corn-an-amazing-advancement-in-ge-crop.html Wed, 05 May 2010 10:52:00 +0530 Using GS corn as a platform would be a quicker way of enhancing the number of transgenes in a single crop variety The trademarked Genuity-SmartStax corn (GS corn) containing eight transgenes-six for pest control and two for weed control-developed through collaboration between Monsanto and Dow AgroSciences, introduced few months ago, is an amazing development in crop genetic engineering (GE). Incorporated into the best of corn varieties, this event is expected to provide the most comprehensive pest and weed control system available, leading to an impressive crop health and increase of whole farm crop yields. The development of Genuity SmartStax corn from the shaky origins of genetic engineering is a fascinating reading. Genuity SmartStax corn GS corn takes care of the major pests, such as the European and southwestern corn borer, northern and western corn rootworm, western bean cutworm, black cutworm, corn earworm, and fall armyworm and also imparts tolerance to both glyphosate and glufosinate herbicides. In addition, the coming together of two giants in the seed industry will encourage other private-private partnerships to further this initiative. Eight transgenes in GS corn Tolerance to aerial pests (three Bt genes): Cry 1A.105 (Monsanto), Cry 2Ab2 (Monsanto) and Cry 1F (Dow). Tolerance to subsoil pests (three Bt genes): Cry 3Bb1 (Monsanto), Cry 34Ab1 (Dow) and Cry 35Ab1 (Dow). Tolerance to herbicides (two genes): Glyphosate (Roundup Ready, Monsanto) and Glufosinate (LibertyLink, Dow, under license from Bayer). Biosecurity evaluation Transgenic crops are evaluated for product efficacy and biosecurity in the laboratory, green house and in the field for over 10 years before commercialization. The GS corn is in phase-IV of regulatory evaluation, the final step prior to the product's planned commercial release in 2010. This phase includes development and testing of best trait and germplasm combinations for commercial launch. All the genes involved in the GS corn were approved in the US in single gene transgenic varieties and are being commercialized in different countries. Each of these eight traits has also been individually approved by the Canadian Food Inspection Agency (CFIA). A refugium is a non-Bt buffer zone in a transgenic crop field to retard the development of pest resistance to the Bt proteins. Earlier a 20 percent refugium was mandatory. In June 2008, Monsanto requested the US Environment Protection Agency (EPA) for a reduction of refugium requirement to five percent for GS corn in the northern corn belt and 20 percent in southern states where cotton is planted. The EPA has now approved a five percent refugium for the product's aerial pest protection. The CFIA has evaluated the potential impact and risk to the environment, by using a five percent non-Bt refugium strategy for the GS corn, and has concluded that 'a conditional authorization until December 31, 2012, for the use of this reduced volume of refugium poses minimal risk to the environment'. Thus both the US and Canada have given short-term approvals for GS corn. Anti-tech activism There has been a protracted and persistent activism against GE crops stemming mostly from Europe for over 15 years. It is not surprising that the activist groups were disappointed when an eight gene product is approved by both the US and Canadian regulatory authorities. Some Canadian farmer and environmental groups said that Canada rushed the approval process ignoring environmental risks and even without making public the basis of their decision. They charged that the CFIA has substantially weakened a critical environmental stewardship rule just for the introduction of SmartStax. Committee for Independent Research and Information on Genetic Engineering (CRIIGEN) alleged that humans are used as guinea pigs for the 'second generation' of genetically modified (GM) crops. The Canadian Biotechnology Action Network, chose the World Food Day (October 16, 2009) as the first 'International Day of Action Against Multinational Corporations'. Some activist groups argue that there might be unintended consequences when so many traits are combined. It should not surprise any one if the opposition to GS corn gains momentum in the coming months. Commercialization process Notwithstanding activist noises, GS corn is being planned to be grown on 30 to 40 lakh acres in the US and Canada in 2010, both for internal consumption and export. With regulatory approvals for import, GS corn will now be exported to Japan, Korea, Taiwan, Mexico, Australia and New Zealand, under the trade names such as Mycogen, Dairyland, Renze, Brodbeck, Triumph, Pfister and Hyland. Certainly there would be several other products similar to GS corn, but using GS corn as a platform would be a quicker way of enhancing the number of transgenes in a single crop variety, not as a gene game but to compound several benefits into a single product. How GE crops evolved? Genetic engineering The concepts of 'biotechnology' (Karl Erkey1919) and 'genetic engineering' (Justin, 1941) came into use long before Watson and Crick (1953) proposed their model of the structure of DNA, the genetic material. It took 20 years of basic research before Stanley Cohen and Herbert Boyer (1973) perfected the recombinant DNA (rDNA) technology. They cut genes of the African clawed toad using restriction enzymes and incorporated them in the genome (total genetic complement) of the experimental bacterium Escherichia coli (E. coli) using the enzyme DNA ligase and demonstrated the expression of the transferred genes in the new environment, a major breakthrough in GE. Genesis of GE crops In 1982, the first transgenic plant, an antibiotic resistant tobacco, was developed. In January 1983, three different teams reported success in using the bacterium, Agrobacterium tumefaciens, a natural genetic engineer, to produce transgenic plants. Soon, using Agrobacterium tumefaciens to carry new genes into plant cells became the most common means of producing transgenic plants. Field tests for GE crops resistant to pests and pathogens were first conducted in the US in 1985 and the first GE tobacco was approved for commercial release in 1986. After getting the approval from the Food and Drug Administration, Flavor Saver, the first GE tomato, with a longer shelf life, reached the US markets in 1994. Between 1995 and 1996, GE soybean, corn and cotton were approved for commercialization in the US. GE crops with several different beneficial traits are now commercially cultivated in 25 countries and imported into five others. Global transgenic acreage has increased from 17 lakh hectares in 1996 to 12.5 crore hectares in 2008. This impressive growth indicates farmer and consumer acceptance of GE crops and products for their benefits. Over 35 crore Americans have consumed GE foods for over 13 years without any discernible untoward health effects showing that GE food crops and their products are safe for human consumption. The most widely used trait in the commercialized GE crops is tolerance to the most important pest in each of such crops as cotton, potato, tomato, and corn, with genes from the universally occurring soil bacterium, bacillus thuringinesis. The other important trait is tolerance to herbicides, to achieve an easier and efficient weed control that facilitates no-tillage farming. There is also a GE papaya with tolerance to the ring spot virus disease in commercial cultivation. An array of GE crops A number of grain, oil seed and vegetable crops with diverse traits for pest, disease (bacterial and viral) and herbicide tolerance have joined the array of GE crops, many of them in very advanced stages of development. Produced through gene silencing, a protocol different from rDNA technology, a variety of coffee without caffeine and a variety of tearless onion are interesting products. GE crops with a number of traits for nutritional enhancement and production of pharmaceuticals are also in advanced stages of development. Golden Rice, rice with genes for Ã¢-carotene, the precursor of vitamin A, is a very promising means to alleviate vitamin A deficiency in the developing countries. GE rice with human milk proteins is designed to provide an efficient infant feed. Rice with higher iron content, a carrot variety with very high levels of calcium and a purple tomato with high levels of anthocyanins that function as antioxidants to prevent several diseases, are fascinating developments in the year 2008. Among the non-food GE crops, genes for number of pharmaceutically active chemicals, vaccines and antibodies have been introduced into crop plants for an inexpensive and large scale production of these therapeutic aids, an area called biopharming. A GE tobacco plant that synthesizes human haemoglobin and another that detoxifies soils contaminated by explosive residues have been demonstrated. A GE blue rose is now available in the Japanese market. GE food grains that withstand drought, flood and salinity are high priority research, and so are those for high yield. Due to the complexity of inheritance of these traits a successful development of these crops would take some years to become a reality. Genes of transgenic crop In all these products only a single gene is involved. For quite long it was an open question as to how many different genes can be genetically engineered into a single crop variety, a process called gene stacking or gene pyramiding, to derive their cumulative benefits. A significant development was Monsanto's Bollgard II, a GE cotton with two stacked Bt genes, Cry 1 Ac and Cry 2 Ab, which provides a better pest control, than with a single gene. In several other crop varieties two genes for pest or viral or herbicide tolerance were stacked. Monsanto announced a triple-stack corn for release in the US in 2009. DuPont stacked five genes in corn to make it both pest and herbicide tolerance. The April 2009 announcement of a transgenic corn with five different genes to synthesize very high quantities of vitamin A, vitamin C and vitamin B9 precursors, was a welcome news, from the points of view of both scientific accomplishment and product benefits. But the GS corn announced in July 2009, caps it all. - C Kameswara Rao, Foundation for Biotechnology, Awareness and Education, Bangalore ]]> <![CDATA[ClinTec on a go global mission]]> https://biospectrumindia.com/news/95/1542/clintec-on-a-go-global-mission.html https://biospectrumindia.com/news/95/1542/clintec-on-a-go-global-mission.html Wed, 05 May 2010 10:50:00 +0530 The global economic meltdown in 2009 forced many companies to minimize expenditure and layoff their employees. The pharma companies squeezed their budgets for getting funds for investments and expenses. As a result, the clinical research businesses were widely affected. But UK-headquartered ClinTec International appears to be recession proof. Even when companies were scaling down their businesses, ClinTec viewed it as a critical period for growth. The company has not only outpaced the clinical research organization (CRO) industry, but also other business industries during the downturn, setting a record of 45 percent growth globally. The company has successfully expanded its client base, signed new contracts with 11 of the world's top 25 pharmaceutical and biotech firms. This success, achieved in a challenging global economic climate, helped the company's founder, President and CEO, Dr Rabinder Buttar, to become a finalist for the UK's Institute of Directors Scotland's Global Director of the Year Award. With its operations in almost all major countries around the world, ClinTec International manages clinical trials in all popular therapeutic areas, including oncology, neurology, cardiovascular, respiratory and gastroenterology. It provides services under all clinical research verticals including clinical operations, data management, statistical programming, medical writing and regulatory affairs for Indian and global pharmaceutical, biotechnology and medical devices industries. Last year, ClinTec played a vital role in facilitating complex restructuring programs for global pharmas that are in search for innovative ways to optimize their R&D efforts. The shift of research delivery from West to East is an area in which ClinTec will be able to provide a credible solution for using a combination of flexible resource solutions and off-shore project delivery. The go global mission There is a fierce competition for patients within the traditional clinical trial territories of Western Europe and North America. Competition for patients, along with escalating R&D costs, force many major pharmaceutical companies to focus on emerging markets to conduct their clinical studies. ClinTec believes that setting up base in emerging countries is a step towards establishing presence in the adjacent regions. Currently, ClinTec has its presence in over 45 countries worldwide and this year, the company has plans to widen its presence in Asia. Apart from strengthening its coverage in Europe, ClinTec is also targeting Latin America and the Middle East and North Africa (MENA) regions for further corporate expansion. Earlier this year, ClinTec announced its partnership with Healthcare Communications Group, US, and now it provides patient recruitment services across its operations worldwide. ClinTec is also a pioneer in middle East, which is regarded as one of the most challenging markets. The company recently launched its operations in Egypt. Dr Buttar says, â€œWe at ClinTec are proud to be at the forefront of adapting and developing new and emerging markets. While North America and the European Union constitute the bulk of the pharmaceutical sales and clinical research development, Egypt and the wider MENA region are growing at a tremendous pace and are estimated to be worth Rs 44,298 crore ($10 billion). Our knowledge of different regulatory requirements and cultures remains our strength and this attracts major international pharmaceutical towards ClinTec.â€? This year, ClinTec is looking at expanding in the Asian market. â€œAsia has become a promising destination for global clinical trials clearly as a result of shortened patient accrual timelines, established clinical research infrastructure and expertise. Unlike other emerging regions, Asia has been involved in clinical trials and most countries in the region have a history of delivering quality clinical trial data for over a decade,â€? says Bindhya Cariappa, director of operations, India and MENA, ClinTec International. â€œWith the highest population density in the world and a variable standard of living, Asia offers huge opportunities for companies from other regions. Asia has more than 400 crore people who are genetically diverse and have a greatly variable healthcare coverage, with patients with unmet treatment needs as well as drug-naÃ¯ve patients,â€? she adds. â€œEurope is an important market for us, and it contributes maximum share of the business, but India is a strong proposition,â€? confirms Dr Butter. With seven years of successful track record, the company is further expanding its business into the Asia-Pacific region this year-targeting Singapore and China. The newer operations not only provide ClinTec International's global biopharmaceutical associates with access to new patient populations, but it also consolidates ClinTec's reputation as a company with a wider global presence. Looking ahead Apart from expanding to newer markets, the company has kept a target to maintain the growth in 2010-11 through the introduction of new offerings and accessing newer geographies. The company further plans to be a leading provider of clinical services at a global scale. It aims to strengthen its patient recruitment services, and plans to open an academy to train people in the area of clinical research from the industry. â€œThe academy will be led by European professors, and the training programs will address the needs of the pharma industry,â€? says Dr Butter. In the coming years, ClinTec is all set to continue its growth trend. The company, which has an estimated revenue of Rs 88 crore ($20 million) has set a target of exceeding Rs 155.34 crore ($35 million) in 2010. About 60 percent of the revenue is already confirmed by its clients. â€œClinTec International is at the top of its growth metrics when compared to competitors. We have met the challenges in 2009 and indeed current projections point to the company's growth in 2010 and 2011 being sustained to the same high levels,â€? says Dr Buttar. â€œOur strong financial performance, achieved during a difficult economic climate, is linked to our established track record at managing activities in a fast and flexible manner,â€? says Cariappa. The 100 percent privately-owned company is attracting attention from a lot of investors, but Dr Buttar is hesitant to get any one on board. COMMENTS â€œEurope is an important market for us, and it contributes maximum share of the business, but India is a strong propositionâ€? -Dr Rabinder Buttar, founder, president and CEO, ClinTec International â€œAsia has become a promising destination for global clinical trials clearly as a result of shortened patient accrual timelines, established clinical research infrastructure and expertiseâ€? -Bindhya Cariappa, director of operations, India and MENA, ClinTec International Jahanara Parveen in Bangalore ]]> <![CDATA[Will science prevail in biotech?]]> https://biospectrumindia.com/news/95/1179/will-science-prevail-in-biotech.html https://biospectrumindia.com/news/95/1179/will-science-prevail-in-biotech.html Wed, 05 May 2010 10:28:00 +0530 After nearly three months of complete silence since the announcement of the moratorium on commercialization of genetically-modified (GM) brinjal crop, the issue is likely to come back into the public arena once again. All eyes are now trained towards the May 19 meeting of the regulatory body, the renamed Genetic Engineering Appraisal Committee (GEAC) in New Delhi. This is a routine monthly meeting of the regulatory agency in the Ministry of Environment and Forests. However, on its agenda this time is the scrutiny of the voluminous data of submissions by various scientists, industry associations, representations of farmers, anti-GM activists and other points raised during the public consultation process conducted by Environment Minister Jairam Ramesh. GEAC may take a call whether further testing will be required to satisfy the “public anger” generated against Mahyco’s Bt brinjal variety in early 2010. The anti-GM groups are upping the ante and have already started a whispering campaign that GEAC may listen to the BioAgri industry and give another go ahead for Bt brinjal commercialization. Technically, the GEAC approval given to the commercialization on October 14, 2009 stands. The February 9, 2010 announcement of the moratorium by the Environment Minister is an administrative nature. Almost all the scientists and legal experts I spoke to are bewildered by the “moratorium” because there is no legal backing for such a decision. GEAC’s routine decisions are just compiled and circulated to the applicants, all members and relevant institutions. There is no provision for a ministerial intervention in such matters. Because, GEAC is the statutory authority and its decisions are final, unless overturned by the Supreme Court. Things are in a limbo only because the BioAgri industry has decided to lie low in the face of overwhelming anger generated against it by the anti-GM groups. In this issue’s Cover Story on Bt brinjal, we have tried to highlight the despair that is now prevailing in the Rs 2,000 crore BioAgri industry. Prime Minister Manmohan Singh had clarified in late February that there is no government policy against GM food crops. This has come as balm to the wounded industry. However, ground realities are different. Almost all the companies which are working on various GM food crops have slowed down the development work. They are not sure whether regulatory approvals will be forthcoming even to conduct field trials to generate data about the various traits. Some research groups have turned their focus to using genetic modification to develop crops with traits for drought resistance, salt tolerance, enhanced nutrition and disease resistance. In a way, these are good developments because India needs crops which can withstand recurring droughts and also use large tracts of high saline lands more productively. It is not just GM crops that are facing the heat in the country. In a rare case, even a biopharma product has come under fire. The ongoing trials for two cervical cancer vaccines, Gardasil from Merck and Cervarix from GSK, have been halted by the government after reports about the death of six young girls in Gujarat and Andhra Pradesh who were administered these vaccines during the trials. The cervical cancer vaccine has become part of the immunization programme in Australia and many other countries. An Indian version is also under development at Shantha Biotech. The recent setbacks to the cancer vaccine and Bt brinjal raise the question whether as a nation we are ready to enjoy the fruits of modern technologies. About the Bt brinjal controvery, Dr Swapan Dutta, DDG of ICAR optimistically remarked that ultimately “science will prevail.” The government is unable to push through the legislative backing for a science-based biotechnology regulatory system for the last six years. I sincerely hope that “science will prevail” in biotech in the short run too. Group Editor sureshn@cybermedia.co.in ]]> <![CDATA[The Next BIG Trends]]> https://biospectrumindia.com/news/95/1632/the-next-big-trends.html https://biospectrumindia.com/news/95/1632/the-next-big-trends.html Thu, 08 Apr 2010 15:15:00 +0530 Healthcare for aging Globally, the population of older people is growing at a rate of 2.6 percent per year, considerably faster than the population as a whole, which is increasing at 1.2 percent annually. According to UN Department of Economic and Social Affairs Population Division report, between 2006-30, the number of older people in less developed countries is projected to increase by over 140 percent as compared to an increase of 51 percent in developed countries. Hence governments in both developed and developing world have launched programs to support the massive aging population. Datamonitor noted that the pharma companies will face growing competition from generics, due to increasingly tough pricing and reimbursement, a clamp down on healthcare spending, and the need to treat patients for longer due to the aging population. These factors prompt pharma companies to adopt a range of corporate strategies to respond to the changing market dynamics. Personalized medicine Recent developments in molecular profiling technologies, including proteomic profiling, metabolomic analysis, and genomic/genetic testing allow the development of personalized medicine and predictive medicine. Personalized medicine will allow healthcare providers to focus their attention on factors specific to a patient to provide individualized care. Companies from different spheres such as informatics IT, health insurance, consumer genetic testing, biotech and pharmaceuticals, and diagnostics are already working on this area. Outsourcing of research and manufacturing Increasing R&D costs, low productivity and profit margins, have forced the big pharma companies to look for outsourcing part of their research, clinical trials and manufacturing activities to low cost countries there by saving on costs and time. In the current era of globalization and competitive market, outsourcing has become the norm for pharma companies. Taking the advantage of the opportunities, Frost & Sullivan noted that companies from Asian region, will take away a major share of outsourcing from developed world. Biosimilars Biosimilars or generic biologic drugs are marketed around the world but are still restricted in the US. This may soon change. While Japan has already given the green signal for biosimilar product and the US is moving  closer to the establishment of an approval pathway; the biosimilars market is set for imminent expansion. Datamonitor noted that the biosimilars market will grow across the seven major markets by 2014 following key patent expiry on  epoetin alpha, filgrastim, interferon beta 1a, interferon alpha, human growth hormone (HGH), and insulin-glargine. ]]> <![CDATA[Ambition: Cutting-edge biotech products]]> https://biospectrumindia.com/news/95/2235/ambition-cutting-edge-biotech-products.html https://biospectrumindia.com/news/95/2235/ambition-cutting-edge-biotech-products.html Thu, 08 Apr 2010 14:32:00 +0530 Premas Biotech, located in sprawling 20,000 sq. ft., is a 100 percent FDI, cGMP compliant, contract research and manufacturing services (CRAMS) organization. 'PREMAS' is the acronym for â€œProduction of Recombinant Molecules for Advancement of Scienceâ€?. The company has been offering services in contract research in cloning, expression and purification, cell based assays, data analyses and biomanufacturing. It has a client base that includes major Indian and foreign drug firms such as Cipla, UCB, Cell Tech, AstraZenca, Johnson & Johnson, Galderma, Agrigenetics and AgBio. Premas is also a part of the $38 million (Rs 173 crore) Open Source Drug Discovery (OSDD) program initiated by the Council of Scientific and Industrial Research (CSIR) in 2008 to facilitate collaborations and combined efforts to find cure to many diseases including TB. The company has 45 employees, of whom 55 percent are postgraduates and doctorate degree holders. Its revenues last year were Rs 33 crore, of which Rs 25 crore came from Illumina business and the rest from the CRAMS and drug metabolizing enzymes (DMEs). Initial hiccups The company was founded in May 2005 and was incorporated in November 2005, however, it took about 16 months to set up the laboratories in Manesar in Haryana. It was in May 2004 that the five founders of the company-Avijit Das, CEO; Dr Rajeev Soni, President and COO; N Kousik, VP Finance and HR; Dr Prabuddha K Kundu, Head of Manufacturing; Praveen Gupta, Head, P&A Unit-came up with the idea of starting a company but investor interest in India was bleak and the founders searched for funding options in Europe. Once the money came in, it was an easy job for the founders to build a state-of-the-art laboratory in molecular biology and biotechnology. They also filed provisional patents for applied research technologies such as diagnostic technology for infectious diseases and proprietary vectors for protein expression in bacteria, yeast and mammalian cells. â€œPeople here have problems in understanding the life sciences business model and the returns are expected overnight at par with IT, which is unimaginable in case of biotech industry. Earlier, there were very few who venture out into biogenerics in life sciences field. We knocked on every big door for one-and-half year to get investments but unfortunately none believed in our project,â€? says Dr Rajeev Soni, President and COO, Premas Biotech. â€œFor us, 2007 was the year of commercial success. In March 2007, we started the fully-equipped functional labs and in May 2007, we received the first CR project and then again in the same month proprietary DNA isolation technique was developed,â€? adds Dr Soni. Strategies for growth Premas has implemented the E-Lab Notebook and Scientific Database Management System (SDMS) that aids its customers to view their experimental data via security-controlled web access, coupled with 21 CFR Part 11 compliance, which is of fundamental importance for data submission. Electronic Laboratory Notebooks record what was done during the course of a scientific experiment, and particularly the inventions that were made for future reference. The company has also been following a unique approach towards reducing wastage in labs. To minimize wastages, one person is trained in doing one key repeatable activity, thus saving time and minimizing human error in order to increase reproducibility to a greater extent. Adopting this technique has allowed the company to reduce the delivery time of proteins from 18 weeks to four weeks plus maximum delivery of about 70 proteins per year. Aiming high for future Premas wants to work with the government and is open to any partnership that can help this niche sector to expand its horizons. On being asked about the aspirations of Premas for future, Dr Soni, says, â€œAs far as finances are concerned, we have reached the neutral stage of financial success and we aim to develop at least five-to-six new technologies from India within next five years.â€? â€œWe want to make the niche, cutting-edge biotech products from India and that is the aspiration of Premas Biotech for the near future. And the research minds at Premas are working to create the novel products relevant to industry in coming years,â€? concludes Dr Soni. Major milestones of Premas Biotech Incorporation in November 2005 Became India's first EOU for services and manufacturing at single site in July 2006 Constructed a 20,000 sq. ft. fully-equipped functional labs in April 2007 Got the molecular diagnostics breakthrough in the form of a novel nucleic acid detection technology in 2008 "We aspire to be a partner of choice in providing the integrated drug discovery solutions" - Dr Rajeev Soni, president & COO, Premas Biotech. "We demonstrated and distinguished ourselves as a capable scientific player in protein expression and purification market by cloning the toughest classes of proteins and also coming out with the innovative solutions to contract research problems" - Mr Praveen Gupta, VP-business development, Premas Biotech "Premas' business strategy aims at gaining efficiency and enabling faster delivery with multi-fold increase in capacity" - Dr Prabuddha Kundu, VP, Manufacturing, Premas Biotech Rahul Koul in New Delhi ]]> <![CDATA[THSTI's interim labs open]]> https://biospectrumindia.com/news/95/2925/thstis-interim-labs-open.html https://biospectrumindia.com/news/95/2925/thstis-interim-labs-open.html Thu, 08 Apr 2010 14:26:00 +0530 The interim laboratories of the Translational Health Science and Technology Institute (THSTI) were unveiled by Prof. G Padmanaban, distinguished biotechnologist, in Gurgaon on March 29, 2010. The laboratories will function for about two to three years from here after which it will be shifted to Faridabad, not far from Gurgaon, to a newer and permanent venue being built at the 200-acre Health Biotech Science Cluster (HBSC). The focus of the THSTI will be to conduct innovative translational research and develop research collaborations across disciplines and professions to accelerate the development of concepts into tangible products to improve human health. The center will be involved in research in relevant areas of immunology, virology, microbiology, structural, chemical and systems biology. Research areas involving the host-pathogen interactions, covering the entire range of expertise and interest from the statistical and epidemiological to the cellular and molecular levels will be considered. Dr Padmanaban, former director of Indian Institute of Science, Bangalore, said, â€œIt is great to see the outcome of all the hard work put in this project and now the efforts have to be directed at making the benefits available to masses.â€? Dr MK Bhan, secretary, Department of Biotechnology (DBT) and chairman of HBSC, said, â€œThis is the first step towards having niche centers in the country on the lines of Max Planck centers. The world-class research accessible to industry along with availability of array of resources will be the priority of the institute.â€? Dr Barabara Alving, director, NIH National Center for Research Resources (NCRR), US, said, â€œIt is good to see such a great effort being made in India and such innovative thinking has good potential of inviting the partnership from us.â€? Dr Srikumar Suryanarayan, CEO, Biotech Cluster; Dr Sudhanshu Vrati, head, THSTI; and Dr Dinakar Salunke, head, UNESCO sponsored Regional Center for Biotechnology (URCB) along with a large number of scientists from National Institute of Immunology (NII) and many senior advisors from DBT were present at the event. The focus of the THSTI will be to conduct innovative translational research and develop research collaborations across disciplines and professions to accelerate the development of concepts into tangible products to improve human health. Later in the evening, a lecture on 'Turning discoveries into treatments: Strategies for translational research' by Dr Alving was held at NII, New Delhi. He gave details of the translation model followed in the US and threw light on the various aspects of Clinical Translational Science Award (CTSA), which is an initiative by NCRR, NIH, US. "It is great to see the outcome of all the hard work put in this project and now the efforts have to be directed at making the benefits available to masses" - Prof. G Padmanaban, distinguished biotechnologist, IISC, Bangalore Rahul Koul in New Delhi ]]> <![CDATA[Lessons for India from swine flu]]> https://biospectrumindia.com/news/95/1709/lessons-for-india-from-swine-flu.html https://biospectrumindia.com/news/95/1709/lessons-for-india-from-swine-flu.html Thu, 08 Apr 2010 14:21:00 +0530 Exactly a year ago, the world was swept by the swine flu scare with the first cases reported from Mexico that spread to all the continents within week. A year later, the swine flu scare has died down. The Influenza A H1N1 virus did not wreak the havoc it was predicted to by some of the world's leading health experts. Experts have learnt another great lesson from this episode that it doesn't pay to press the panic button at the slightest pretext. The global scare created in mid-2005 about bird flu sweeping the world within months of an outbreak and hitting the most vulnerable sections of the society too has not happened. Does it mean that health experts are scare mongers? The jury is out on this but we may not have the verdict too soon. Is it not better to be safe than sorry? What about the scenario in India? Swine flu is not a word that scares anyone now in the country. The panic queues that formed outside the swine flu testing centers in June-July 2009 has been replaced with a calm. The first set of vaccination of health workers who will be in the frontline of handling future swine flu cases has started in many states in early April. Imported vaccines, supplied by Sanofi Pasteur, has been provided in adequate quantities to key affected states. Two indigenous swine flu vaccines, developed by Zydus Cadila and Serum Institute of India are currently in phase II and III trials. Advance results so far indicate good efficacy and the regulator, Drug Controller General of India (DCGI) may give the final go ahead by April-end. Delhi-based Panacea Biotec is investing in a new swine flu manufacturing facility in Punjab. This is the good news from the swine flu scare for the country. For the first time, the country has geared up well to face similar epidemics in the near future. The capabilities developed to produce swine flu vaccines will come in handy to deal with influenza epidemics in the future. Influenza was one area that was not taken seriously in the country so far with less that 0.5 percent vaccination against any type of this viral epidemic. World Health Organization (WHO) goaded Indian policy makers into action four years ago when it anticipated an outbreak of bird flu (Influenza A H1N5) and selected a few Indian vaccine makers to provide them with the expertise. This advance planning helped the country tide over the swine flu crisis that came in instead. Hopefully, India's public health policy makers have learnt the right lessons from the swine flu episode and will not delay sanction of funds to create buffer stocks of essential vaccines. This was one area India's policy makers failed miserably. A proud nation that aspires global leadership should not be dependent on global NGOs like Bill and Melinda Gates Foundation and even GAVI (Global Alliance for Vaccination and Immunization), a consortium of multinational vaccine makers, to provide essential medical treatment to its citizens. India will require just over a billion dollars or Rs 4,500 crore annually to vaccinate all its vulnerable citizens and stockpile some essential vaccines to deal with epidemics like swine flu. It is important to keep adequate stocks and spare production capacity within the country. Luckily, in the swine flu episode India did not have to depend on limited spare vaccines which would have been doled out if the epidemic had become a major health scare in 2009. The nation is in a happy position in accessing financial resources thanks to the high economic growth rates. The Manmohan Singh government should channel additional resources similar to what is being pumped in the education sector ($30 billion) to this equally fundamental task of safeguarding the health of the nation. Resources are the issue here. A national change in mindset is required to anticipate and plan for looming episodes of epidemic diseases. Group Editor <sureshn@cybermedia.co.in> ]]> <![CDATA[India market charged with deals]]> https://biospectrumindia.com/news/95/1152/india-market-charged-with-deals.html https://biospectrumindia.com/news/95/1152/india-market-charged-with-deals.html Thu, 08 Apr 2010 14:18:00 +0530 India market in 2009 has seen a rise of inbound deals both in terms of volume and value. â€œIndia is the place to be and every company has an India strategy. Inbound deals in India are either because of geographical expansion or from the CRAMS side,â€? says a Mumbai-based analyst. There have been multiple small scale outbound deals but not a large scale blockbuster transaction like the Dr Reddy's Labs acquisition of Betapharm. â€œThere has been an overall contraction of cross-border merger and acquisition (M&A) transactions between 2008 and 2009 in India. The drop in outbound deals was even more visible (30-40 percent). In fact, many Indian companies had to offload their domestic and foreign assets to shore up liquidity,â€? says Kapil Khandelwal, director, Makven Capital, a niche investment banking and advisory services company. A quick view across all sectors in 2009 reveals an overall drop in M&A deals in India. Indian companies were involved in a total of 356 M&A deals, which dropped 34 percent as compared to 2008, according to a study by Venture Intelligence, a research service focused on private equity and M&A transaction activities in India. However, with the global financial crisis beginning to ease, industry observers believe biotech might be the next top acquisition target.for most M&A and private equity deals. A recent study by Grant Thornton, an advisory firm reveals that the sectors where PE firms are most active now are pharma, healthcare and biotech, along with real estate and infrastructure management, IT and BPO. Analysts predict that in the near future though a large scale outbound acquisition from India looks remote but this will not stop the flow of small and mid-size deals. Outbound deal aversion Most analysts opine that companies are currently on the wait and watch mode. Navroz Mahudawala, associate director, Transaction Advisory Services, Ernst & Young, says, â€œBetween 2004 and 2007, Indian companies were on a major acquisition spree with Dr Reddy's Laboratories (DRL), Ranbaxy and Wockhardt being in the forefront for outbound deals. Various factors have changed since then.â€? Today, Wockhardt is a debt-ridden company trying to raise cash by offloading non-core businesses such as animal healthcare and hospitals, while Ranbaxy is now a subsidiary of Japan's Daiichi Sankyo Group. DRL has incurred massive losses in its German subsidiary Betapharm. These top Indian pharma companies have now given way to newer rivals in the market-Glenmark Pharma, Zydus Cadila, Lupin and Piramal Healthcare who, however, go in for small outbound deals or brand acquisitions. Outbound deal sizes today vary anywhere between Rs 45-225 crore ($10-50 million) unlike a few years ago, when Indian companies had ambitious targets of hitting the Rs 2,000 crore ($500 million) plus mark. â€œBeing in the cautious mode, there were few deals across the globe and now there is more of an inbound focus,â€? adds Mahudawala. A Venture Intelligence study revealed that in life sciences sector, in 2008 there were 35 outbound deals, 2009 saw a sharp dip to less than half-13 deals to be precise. This coupled with the economic downturn which hit world markets led to credit squeeze. Sujay Shetty, associate director, PricewaterhouseCoopers, says, â€œSince the markets were down, Indian companies became too cautious and did not want to spend money for any acquisition. The financial slowdown resulted in lack of money and management, and the companies started concentrating on adjustment, on getting more synergies out of the older acquisitions.â€? This was a wake up call for many Indian companies. â€œThe global financial crisis and fears of the slowdown in the economic growth activity impacted the valuations of the companies. Many active acquisition-discussions for outbound deals slowed down or literally froze as the expectations of rock-bottom valuation emerged rather than inherent value of the assets. This delayed the deal making and closure activities,â€? explains Khandelwal. Indian companies in the CRAMS space, however, have been consistent in their outbound investments over the years, they have strengthened their market position by actively pursuing overseas acquisitions to expand their customer base and this also includes the period of global economic crisis. â€œThere have been more deals in CRAMS, formulations and generics, but, hardly any in the API segment,â€? says Mahudawala. Jubilant Organosys acquired Hollister-Stier Laboratories, US, for Rs 550.76 crore ($122 million) in 2007 and Draxis Health, Canada, for Rs 1,182 crore ($262 million) in 2008. These acquisitions have provided Jubilant access to new technologies, expanded service portfolios, global manufacturing and research sites, international regulatory approvals and a ready client network. A KPMG report suggests that private equity firms have invested in Indian CRAMS companies for funding the expansion of their research and manufacturing capacities and for acquisitions. In 2008, Jacob Ballas and New York Life Investment Management invested Rs 194 crore ($43 million) in Themis Laboratories and Baring Private Equity Partners India invested Rs 67.72 crore ($15 million) in Sphaera Pharma. Outbound deals have also shown a consistency in cases where Indian companies are looking at entering new geographical regions. â€œCompanies that are overexposed to developed markets like the US and Europe, where there is high price erosion or competition, they start looking at other markets like the emerging markets, some look at Africa or Latin America for expanding their presence,â€? adds Shetty. Above all, the year 2009 was a year of consolidation and emphasis on increase in sales for Indian companies. This trend, it is said, will continue in the coming years. Dipta Chaudhury, program manager-South Asia and Middle East, Pharma and Biotech Practice, Frost & Sullivan, says, â€œThough the recession had hit many global companies, performance of Indian companies had remained steady. This, however, required concentrated efforts and also reduced the risk appetite for the companies. With global mergers and acquisitions also taking place, the pharma scenario was unpredictable on an international level. This reduced the scope of deals from India in 2009.â€? A KPMG report points out that in the near term, the focus will be on consolidation, as the life sciences sector continue to face regulatory barriers, pricing and intellectual property challenge. Strategic inbound focus India Inc, now, has an inward focus which means an M&A could happen at two levels â€“ either through domestic acquisitions or being acquired by a foreign company. Mahudawala says, â€œIt is on a case-by-case basis. Most of the inbound deals happened out of financial compulsion or specific strategic decision like the Wockhardt-Abbott and Orchid-Hospira deals.â€? There is definite activity in the biotech segment, particularly in the vaccine segments. The global H1N1 and other endemics are one of the key drivers for M&A activities to acquire assets and capacity that are attractively valued. â€œThe reason for increase in inbound deals is simple, larger foreign companies look at India as an emerging power and can add significantly to their numbers. The current trend is that the MNCs are targeting Indian companies that have strong foothold in the local market. So, the deals are not very segment specific. But vaccine market is quite hot these days,â€? adds Shetty. The Shantha Biotech-Sanofi Pasteur deal that happened last year was a landmark deal with Shantha selling out at eight times their valuation at Rs 3,475 crore ($770 million), as was much unexpected deal of Orchid selling its injectibles business to US-based Hospira in December 2009. â€œAs the value of the Indian assets and subsidiaries have decreased, the inbound deals become an attractive value proposition for foreign players to increase their stake in their Indian subsidiary, like the deal by Pfizer, or acquire an outright stake into Indian companies.â€? adds Khandelwal. Apart from the large scope of the Indian market, the competitive advantage enjoyed by Indian companies is unparalleled in terms of cost, and competency. â€œIn addition, through experience it has been seen that Indian companies enjoy the privilege of understanding the Indian market better than any new entrants.â€? adds Chaudhury. The way forward Now, the India market is far too attractive and dynamic, and it is driving the growth of global market in several segments. While vaccines are pitched to be the hot pick for deals and transactions, other sectors include medical devices, imaging and diagnostics. â€œIn terms of volume, we can expect deals in the medical devices, life sciences tools, medical equipment and testing and diagnostics segments to be comparably high, but the average ticket size in such sectors will be smaller,â€? says Khandelwal. Despite facing a difficult year, margins for most companies have picked up in the first half of 2010 and Indian companies are back on the track of going global. â€œThe economic climate is improving and the funds are available. Valuation overseas is also better than in the domestic market. Indian companies can go out for quick franchisees and businesses,â€? adds Shetty. There is scope for a pick-up in the small outbound deals but the focus again will be on domestic consolidation and inbound deals. An outbound deal of over Rs 2,000 crore ($500 million) scale seems highly unlikely. There is a possibility of a large scale deal if the Sun-Taro issue is settled. But, we will see deals mostly in the range of Rs 45-225 crore ($10-50 million). â€œOutbound deals from India will definitely see a rise in the coming years. With Indian companies showing confidence in their business model and expansion plans, they will allocate a certain percentage of their income towards outbound deals. However, most of the large Indian companies in the pharma sector have already invested for establishing offices in across the world and are still integrating their acquisitions,â€? adds Chaudhury. Industry watchers are positive that inbound deals will definitely see a surge in the second half of 2010. Talks about two big pharma companies' plan for large scale acquisition in India are doing the rounds. â€œThere are certain factors that may impair too many inbound deals from happening in the coming years such as exaggeration/over evaluation of a company, and quality issues as seen in the case of Ranbaxy),â€? adds Shetty. Experts, however, caution. Market analysts believe that as of now there are very few sellers from India because of expectations reaching higher levels. While commenting on the market scenario, CEO of a top pharma company, says, â€œIndians become unrealistic when it comes to valuation of their assets. This might prove to become a hindrance to inbound dealsâ€?. Outbound/Inbound deals M&A transactions in HLS sector Year No of Deals Amount ($ M ) 2009 41 $2,101m across 19 deals with announced value 2008 67 $5,692m across 33 deals with announced value Inbound M&A transactions in HLS sector Year No of Deals Amount ($ M ) 2009 13 $1,770m across 11 deals with announced value 2008 4 $4,898m across 3 deals with announced value Outbound M&A transactions in HLS sector Year No of Deals Amount ($ M ) 2009 13 $113m across 5 deals with announced value 2008 35 $490m across 11 deals with announced value Source: Venture Intelligence Buyer Target Description Millipore Corp, US Millipore, India Majority stake in their Indian subsidiary Aurobindo Pharma Trident Life Sciences Merger with wholly owned subsidiary Merck KGaA (through Merck Specialities) Bangalore Genei (India) Sanmar Group's company that specialises in developing products for proteomic and genomic research Biocon IDL Specialty Chemicals Fully-owned subsidiary of Gulf Oil Corporation PerkinElmer, Inc Surendra Genetic Labs Acquired the genetic screening business Serum Institute Orchid Chemicals Open market stake buy out Abbott Wockhardt Purchase the nutritional business of Wockhardt Sanofi Pasteur Shantha Biotech Acquisition of MÃ©rieux Alliance's French subsidiary, ShanH, which owns a majority stake in vaccine company, Shantha Biotechnics Daiichi Sankyo Zenotech Laboratories Open offer to increase stake Pfizer, USA Pfizer India Open offer to increase stake Ambalal Sarabhai Enterprises Suvik Hi-tek Stake acquisition Emami Zandu Pharmaceutical Works Increase stake in the company Lupin Pharma Dynamics Majority stake in the company Panacea Biotec (through its subsidiary Kelisia Holdings) Pharm Athene Inc Stake in the company Matrix Laboratories Fine Chemicals Corp Increased the stake in the company to 100% Perrigo Company Vedants Drugs and Fine Chemicals Majority stake in the company Cadila Pharmaceuticals Novavax JV formed under CPL Biologicals to manufacture vaccines Kerala Ayuveda Arya Vaidya Pharmacy Merger Vetoquinol Wockhardt Acquired animal health division Lindopharm GmbH, Germany Wockhardt Acquired German business Esparma of Wockhardt Pfizer Animal Health Vetnex Animal Health Limited Exit by ICICI Ventures Lanxess AG Gwalior Chemicals Acquired chemical businesses and assets Camlin Fine Chemicals Sangam Laboratories Entry into the alternative medicine space Novartis AG Novartis India Open Offer to increase stake Lupin Generic Health Increased stake from 30% to 50% Ranbaxy Biovel Lifesciences Entry into vaccines business "The global financial crisis and fears of the slowdown in the economic growth impacted the valuations of the companies. This delayed the deal making and closure activities" - Kapil Khandelwal, director, Makven Capital â€œBetween 2004 and 2007, Indian companies were on an acquisition spree with Dr Reddy's Laboratories, Ranbaxy and Wockhardt being on the forefront for outbound deals. Various factors have changed since then" - Navroz Mahudawala, associate director, Transaction Advisory Services, Ernst & Young "The reason for increase in inbound deals is simple, larger foreign companies look at India as an emerging power and can add significantly to their numbers. The current trend is that the MNCs are targeting Indian companies that have strong foothold in the local marketâ€? - Sujay Shetty, associate director, PricewaterhouseCoopers "Outbound deals from India will definitely see a rise in the coming years. With Indian companies showing confidence of their business model and expansion plans." - Dipta Chaudhury, program manager, Pharma and Biotech Practice, Frost & Sullivan Nayantara Som (Inputs: Jahanara Parveen & Rahul Koul) ]]> <![CDATA[â€œIndia is a great economic story for next 50 yearsâ€?]]> https://biospectrumindia.com/news/95/5987/india-is-a-great-economic-story-for-next-50-years.html https://biospectrumindia.com/news/95/5987/india-is-a-great-economic-story-for-next-50-years.html Thu, 08 Apr 2010 12:29:00 +0530 The British pharma company, GlaxoSmithKline (GSK), is changing its focus towards developing countries for manufacturing and business. This promises not only a steady revenue but also growth. It was with this intention that GlaxoSmithKline unveiled a new factory in Nashik in Maharashtra to manufacture Albendazole tablet for the World Health Organization, to eliminate lymphatic filariasis (LF)-a painful parasitic infection spread by mosquitoes that causes grotesque swelling of the limbs, breasts and genitals. Andrew Witty, CEO of GSK, inaugurated the facility built at a cost of Rs 1.5 crore. The factory can make 30 crore tablets, when fully-operational later this year. The new plant will produces about one-eighth of GSK's medicines across the world. And will be an important facility in GSK's agenda to eliminate LF by 2020. The company has been working towards the common goal of eliminating LF with partners in the global alliance for over a decade. GSK has been present in India for a very long time. It is also one of those few foreign-owned pharma firms that are listed on Indian stock exchanges. It has an annual turnover of Rs 1,859 crore and a market share of 5.3 percent, ahead of even the now integrated Pfizer India (3.5 percent). It is probably the leading MNC for vaccines in the prevention of hepatitis A, hepatitis B, influenzae, chickenpox, diphtheria, pertussis, tetanus, rotavirus and cervical cancer. It is perhaps the first company to go into branded generics with a portfolio of prescription medicines ranging across therapeutic areas such as anti-infectives, dermatology, gynaecology, diabetes, oncology, cardiovascular disease and respiratory diseases. Witty has also chalked out ambitious plans for Least Developed Countries (LDCs). First of which is the establishment of a patent pool to encourage R&D of drugs for neglected tropical diseases. Malaria would be one such disease that will be the center of focus. The GSK team has also given shape to a strategy of differential pricing wherein there will be a price slash of almost 75 percent and reinvestment of around 20 percent of their profits on infrastructure development in the LDCs. In an exclusive interview with BioSpectrum Andrew Witty shares more about GSK's plans for India. Q What will be India's role in GSK's overall strategy especially in areas like research? The industry is going through a change and there are many changes underway for us to adjust the business and research model, which was essentially designed in the 1970s and built in the 1980s. India itself is a key priority for GSK. This is one of the greatest emerging economies of the world and will be a great economic story in the next 50 years. I personally believe that GSK is as Indian as any other Indian company is. Our priority in India is to see that all our businesses in India are well established and in tune with the current business trend in the country. This is a huge manufacturing environment for GSK. The Nashik facility itself manufactures around one-eighth of the global volume of GSK's medicines. Over a period of time, you will see that GSK will have more manufacturing facilities in India. And of course, I would also like to see the increase in activity in areas such as vaccines and a few more research projects. In my view, the center of gravity of GSK is moving towards the east â€“ towards India, China and emerging nations of the world and that is going to have implications in our other businesses too. India will be an important manufacturing and growth point. It is a market that has demonstrated success in a variety of strategies. Q GSK sells a lot of off-patent drugs in India, are you comfortable with this business model? In India, we have just one granted patent product. So, by definition all that we sell in India is off-patent. I am comfortable with that approach. The GSK business subsidiary in India is one of the largest international subsidiaries and GSK can now compete neck and neck with the biggest of the pure Indian businesses. In terms of our broad agenda, I believe we are fortunate to live in a remarkable era of change. GSK tries to provide quality medicines that make a difference to a wider population. For that we have to create a bigger portfolio of medicines at different prices so that all people can get the same benefit of quality medicines. We have achieved that through acquisitions. For example, last year, we acquired Stiefel Laboratories that has made GSK the world's largest dermatology company. In India, we have partnerships with Strides Arcolab and Dr Reddy's Laboratories. Those partnerships supply a broad portfolio of products outside India, which allow us to have a bigger presence in those markets. Q Will vaccines have a significant contribution in GSK's growth story? Vaccines contribute to our growth in regions like India where there is a demand for cost-effective healthcare. We have done that in the former Soviet Union. It is our intention that we have the state-of-the-art vaccines available to India. Our facility in India is involved in two most modern vaccines and we are also trying to extend our capacity for other vaccines in India. Those are the subject of many conversations that are going on at the moment and by next year we will make progress in that. Q How favorable is the IP regime in India for GSK India? We will see a robust IP framework being enforced in India. I am very positive about the direction that the Indian government has chosen, but, I fully-anticipate that it will take a long time. India, will be a relatively lower priced market, because, it is emerging as a nation. It will not be realistic to say that just because there is a patent hence all the prices will go up. I will not let the issue of patents be a problem. Patents are a long-term opportunity to add value to your research. Later, Indian discoverers can be incentivized to come up with innovative medicines and they can also get returns of their investments. As the government adopts an IP framework what it needs to do over time is to adopt enforcement because there is no point in adopting a framework if you do not enforce it. Q What made GSK develop the model of differential pricing of its products for different regions of the world? I have spent most of my career in markets like Africa, and Asia Pacific including India. During that time, I realized that we cannot miss the opportunity to be engaged in the evolution of these markets. Today, most countries recognize that for different products, prices will be different in a market with high GDP than a market with low GDP. I would not think it would be fair to say that just because you cannot afford medicines at the American price nobody gets it. So, I will have to find a middle way and that is the process we are going through now. It is thus reasonable to recognize that the prices in Manila will be different from that of Malaysia and the prices in Malaysia, be lower than Manhattan. Last year, in April 2008, we reduced the prices of all our patented medicines in LDCs by 75 percent. In the middle income countries we are engaged in bilateral dialogues with those countries and zeroed in on a price that is appropriate for that country. In middle income countries, you need to be more customized in your approach whereas for the LDCs the level of poverty is low and it makes sense to have a more common approach. The problem is-all these years we have tried to sell same solutions to different problems. It is not likely to work. Somewhere down the line you need to incentivize research and the investments made into it and that cannot happen if there are no returns. So, I believe we need to open up access to the broader population, not to destroy incentivizing research and to be critical. Q GSK has come with the idea of a patent pool for neglected diseases for LDCs. Can you throw light on this concept? GSK is particularly looking at the 15-16 tropical diseases identified by the US FDA and the poorest countries in the world. In that we create a patent pool where we will put in all the patents of our molecules in these diseases and most importantly, our intellectual know-how and knowledge. We will make these patents available free to any collaborator, discoverer, researcher who wants to work with us or simply take that data to work on their own. We did that because for the neglected tropical diseases there is no marketplace unlike CVS, cancer or diseases that dominate the West. The marketplace essentially stimulates research. In the case of neglected tropical diseases, although they are hugely common in the LDCs there is no marketplace because the people who suffer there have no money. So, to rely on the market place to stimulate the discovery process is never going to happen. In this case, we can invite governments or NGOs to create stimulation and I believe we can make it more attractive for other researchers to do their own research. The whole idea of a patent pool is that we look at a situation where there is no market, try and make it easier for academic research collaborations, and bring out good ideas. We have extended that in the last few months by looking at malaria as a particular disease and we have published all the possible chemical structures that GSK has which has activity against malaria and we took 20 lakh chemicals screened them against malaria and we have found 13,000 chemical structures that have activity against malaria. We make that publicly available and put in on the web where any scientist can use those molecules and try and develop a drug. We are trying to develop alternative methods to stimulate research in the areas where there have been no breakthrough in years. Albendazoleple, for example, has originated in animal health research, but, we should not rely on animal research to save 60 percent of the world's population. We need to find creative ways to engage companies, NGOs to challenge our intellect to find breakthroughs. Q Are there any reasons for GSK's late entry into UNITAID's patent pool? So far, there is no approval given to us to join in but there is a dialogue involved. We involved our HIV subsidiary's CEO for a meeting with the UNITAID to workout details. Secondly, we ourselves have a patent pool where access to all of our molecules, patents and HIV drugs are available to generic manufacturers. And, unlike the proposed UNITAID bill, we do not charge a royalty. Q What is your opinion on the hybrid model adopted by big pharma companies, will GSK go for that model? I am not interested in pure generics. So, while I am here you will never see GSK go up against a DRL or Ranbaxy in the US. I am not interested in that area. Q Does it make sense to invest in lymphatic filariasis (LF) disease area, over, say oncology? LF has a large population and around 120 crore people today suffer from LF. It is one of the top 15 neglected diseases in terms of presence along with others like malaria. GSK had been producing albendazole and it also applies to LF. It is all about applying your skills to the challenge that exists. So, the question of whether this is a competitive area when compared to other diseases we can work upon, the answer in this context is that it is not about 'Albendazole' and HIV is another area we are looking at for instance. So, here we put in all our patents in HIV at the disposal of generic manufacturers including Indian companies to supply tablets to LDCs to increase volumes. Q In LDCs, GSK is planning to reinvest 20 percent of its profits in infrastructure building. Is there a similar model for emerging nations? In the LDCs, we will reinvest 20 percent of our profits on infrastructure because in those countries that is often one of the main challenges. That is a piece of the puzzle that is not fixed and we have not made such a commitment in emerging markets. It would be wrong for us to make such a commitment across all nations. This is on the basis that we want to engage in a bilateral task with government in those regions. Q What plans does GSK have for India as far as acquisitions and alliances are concerned? I would be dishonest if I say I am not looking at any acquisitions in India. Clearly we are looking at an acquisition. We are a cash-rich company both in India and globally. But, we are cautious and continue to look out and India is a great target. Frankly, there are companies here that do not know the actual worth of their assets and come up with unrealistic valuations. The reason I like alliances is that you do have to put a huge capital to have a competitive advantage. There are plenty of opportunities for alliances both with Indian companies and non-Indian companies. We are very thoughtful of the current deal structure that we use. Nayantara Som in Mumbai ]]> <![CDATA[â€œWe'll have 120 scientists by year endâ€?]]> https://biospectrumindia.com/news/95/7806/well-have-120-scientists-by-year-end.html https://biospectrumindia.com/news/95/7806/well-have-120-scientists-by-year-end.html Thu, 08 Apr 2010 11:46:00 +0530 Dr Sudhir Nambiar, head of Pharma Development Center, AstraZeneca has nurtured the growth of the center that was set up in 2007 with an initial investment of Rs 67.44 crore ($15 million). This is AstraZeneca's fourth product research and development (PR&D) facility and the only one outside Europe, the other three facilities are in UK and in Sweden. In an interview with BioSpectrum, Dr Nambiar shares his plans for the center and the strategy he has chalked out to align the facility in India with the company's overall global plan. Q What are the major activities carried out at the AstraZeneca's Pharmaceutical Development (PD) facility? Safe, efficient and scalable processes for developing drug candidates are allotted to this center by the Global Project Management Group. The candidate drugs originate from any of the AZ discovery sites could be in the areas of neuroscience, pain, gastrointestinal, infection, respiratory and oncology. We optimize processes keeping green principles in mind. We develop analytical methodology to monitor the progress of reactions and to check the quality of the intermediates and finished products. A solid state group of the company studies the crystallization processes in detail while developing the right polymorphs. The process engineering group ensures the safety and scalability of the processes. We have a strong process safety group that ensures the safety of processes that are scaled up. Other notable departments include the QA and the project management group. We also recruit accomplished scientists who do not want to be burdened with significant administrative responsibilities on the science ladder so that they can focus on improving the scientific quality of projects. Q How important is India for AstraZeneca as far as pharma R&D is concerned? Pharmaceutical Development facility is a strategic arm of the Global Pharmaceutical Development function of AstraZeneca. We have a vision of developing processes from the discovery stage to the launch stage just like the other global PD groups. In fact, we are currently growing unlike other groups and hope to meet our budgeted target of 120 scientists by the year end. Q What is the role of the center and is there any specific disease focus? The Drug Discovery program at Bangalore is focused on finding a cure for TB. The PD Bangalore group will develop processes to any candidate drug (CD) emerging from the Drug Discovery Center, since these are received through the Global Project Management system just like any other CD from a European/ US Center. In fact, we are currently working on developing a suitable process for the first CD discovered in Bangalore. Q What have been some of the achievements of this particular center since its inception? The center has delivered an increasing number of global projects each year since 2007. It has demonstrated that it can develop innovative, safe, efficient, and globally-competitive processes to candidate drugs. It has proved that it can do this relatively inexpensively when compared to the European Centers. The contribution has been significant, so that a decision has been made to expand the facilities in Bangalore. Q Why was India chosen in the first place, considering that it is known more for its development than discovery capabilities? We develop processes toward new chemical entities (NCEs). This is different from developing processes to generic molecules. However, India was chosen due to its large talent pool of development chemists. It takes approximately a year to train chemists to develop processes toward NCEs. Q What is the contribution of this facility in AstraZeneca's overall India R&D program? The PD facility is a world-class center where cutting-edge science is performed. It gives an opportunity for Indian scientists to work on global projects in their own backyard. Along with the equally-sized and independent discovery group that is focused on finding a cure for TB, it reflects AstraZeneca's substantial R&D investment in India. Q How will you align the overall activities in this facility with the existing global PR&D programs? Since we get projects through the global PM group the work we do is no different from the work done by the other sites in Europe. The candidate drugs developed by PD, Bangalore are sent to Europe for formulation, safety, toxicology and finally clinical studies. We work in a truly global fashion in that we interact closely with our counterparts in Europe. While export/import of best practice is a continuous process. Q Can you share about the current pipeline of candidates discovered by the company? We are currently developing processes towards molecules from all areas including neuroscience, oncology, respiratory and infection. Since we started our activities relatively late compared to Europe, most of our molecules are in phase I and phase II stages of clinical trials. Q What have been the overall investments for this facility? How many scientists have been recruited for this center? The center was started with an initial investment of Rs 67.44 crore ($15 million). Right from inception the total investment of the company would be around Rs 89.92 crore ($20 million). The center is equipped with state-of-the-art equipments such as NMRs, LCMS, LCMSMS, XRPD, RC1, DSC, TGA, parallel synthesizers, and catalyst screening kits. Currently, we employ around 100 scientists who are a mixture of process chemists, analytical chemists, process engineers, process safety assessors, scale up personnel, QA and project managers. An expansion to accommodate additional personnel is currently on for which AstraZeneca has invested additional Rs 8.99 crore ($2 million). Q AstraZeneca is going through a major restructuring process in India, will this have an impact on its R&D programs? Currently, our recruitment is continuing as planned. At this time, we believe that the restructuring program will not adversely impact Indian operations. Q Are there any plans for any collaborations with other research centers/institutes in India? AstraZeneca supports research in a premier research institution in India. We provide scholarships to students at an Indian educational institution. We conduct open houses every year where we invite local students and teachers to visit our premises and understand the research being conducted. We host summer trainees from various Indian universities as well as from other global universities like Cambridge in the UK. We also train fresh science and engineering graduates in important aspects of process safety and release them to Indian industry thereby showing our commitment to improving process safety standards in India. Q Apart from India, will we be seeing similar centers in other emerging nations? AstraZeneca has a small scale center in China. At this point of time, there is no concrete plans for setting up centers in other emerging nations. Q As far as drug discovery is concerned, where do you see India in the coming decade? I predict that drug discovery activities in India will increase. I am very hopeful of a NCE coming from India. Q What is the future plan to take this center to the next level of growth? Currently, we are focusing on the early stage of projects and we are in a learning phase especially with late phase process development. As we progress, we expect to develop processes that will hopefully help to launch a new molecule in the market in future. While we have established a strong tradition of project delivery at relatively lower cost, we cannot rest on our laurels and need to continue our growth pace. Nayantara Som in Mumbai ]]> <![CDATA[Merck-Millipore merger-A $2.9 bn biosupplier giant takes shape]]> https://biospectrumindia.com/news/95/1214/merck-millipore-merger-a-2-9-bn-biosupplier-giant-takes-shape.html https://biospectrumindia.com/news/95/1214/merck-millipore-merger-a-2-9-bn-biosupplier-giant-takes-shape.html Thu, 08 Apr 2010 11:43:00 +0530 Acquisitions are common in the life-science tools sector as large companies seek to fill gaps in their productportfolios and broaden geographical reach by buying-out smaller peers. Recent deals such as industrial conglomerate Danaher Corp. agreeing to buy MDS Inc's analytical-technologies business, along with Life Technologies Corp's mass spectrometry business and Agilent Technologies acquiring Varian Inc, are cases in point. However, Merck KGaA, the global pharmaceutical and chemical company's $7.2 billion agreement to acquire Millipore Corp., the US supplier of equipment to biotechnology companies, has surprised many. The diversification strategy employed is different. This acquisition adds to Merck's portfolio a highgrowth business that is not vulnerable to patent expiry as the company's pharma business. The Deal As per the deal, Merck will acquire all outstanding shares of common stock of Millipore, for $107 per share in cash, or a total transaction value of $7.2 bn, including debt. The acquisition will be funded through available cash and a term loan. The transaction is approved by the boards of directors of both companies. Together, Millipore and Merck will create a $2.9 billion world-class partner for the life sciences sector, achieving significant scale in high-margin specialty products with an attractive growth profile. Thermo Fisher Scientific, the biosupplier giant had also showed interest in buying Millipore. But Merck's $7.2 billion agreement to purchase Millipore topped the rival bidder's offer of about $6 billion. Diversification Plans Industry experts see this acquisition as an important step in the transformation of Merck. Mr Sujay Shetty, associate director, PricewaterhouseCoopers, says, â€œThe acquisition is a highly complementary, strategic deal, which will reduce Merck's reliance on pharmaceuticals and will enable Merck to straddle the chemical and pharmaceutical industries by offering equipment and technologies to help its customers in drug discovery research and processing.â€? In addition, the transaction will lead to a more balanced business profile for the group. Currently, the chemicals business sector generates around 25 percent of Merck's total revenues. Following the transaction, the chemicals business will contribute 35 percent of the total group revenues of $12.02 billion (â‚¬8.9 bn), driven by its strong liquid crystals business and the new world-class life sciences business. â€œThis transaction is very attractive to shareholders, customers and employees of both companies,â€? says Dr Karl-Ludwig Kley, chairman of the executive board of Merck. â€œThis is a combination with an excellent strategic fit, which will allow us to cover the entire value chain for our pharma and biopharma customers, and offering integrated solutions beyond chemicals,â€? he adds. Millipore has a strong position in the attractive bioresearch and bioproduction segments, offering a comprehensive range of products, technologies and services for pharma and biotech companies, as well as for academia, to improve laboratory productivity and to develop and optimize manufacturing processes. In 2009, Millipore generated sales of $1.7 billion, with around 6,000 employees in more than 30 countries. Martin Madaus, chairman, president and CEO of Millipore, says, â€œOver the past five years, we have transformed Millipore into a life sciences leader by driving innovation, entering new markets, and generating exceptional operational performance. The deal, which is the outcome of a thorough strategic review process, is a validation of the tremendous value of the Millipore brand and a testament to the value this transformation has created for all of our stakeholders.We are excited to join a high-quality company like Merck as we will gain greater scale and scope in the life sciences industry. This is a very positive outcome for our employees and customers as we continue to build on our strategy for growth, while maintaining our headquarters in Billerica.â€? Together, Millipore and Merck will have a significant presence in high-growth segments and an enhanced  geographic presence. Combining the research and development capabilities of both companies will create a powerful innovation platform to develop cuttingedge technologies that are tailored even more closely to the needs of customers. Dr Kley adds, â€œBy combining Millipore's bioscience and bioprocess knowledge with our own expertise in serving pharma customers, we can unlock the values in our chemicals business and transform it into a strong growth driver for Merck. Through this acquisition, we will expand the overall product offering of the Merck Group, using the well-recognized Millipore brand in addition to our own brand.â€? While the Merck-Millipore deal is unlikely to spark a wave of acquisitions immediately, the fact that Merck was willing to pay a high price for Millipore resets the valuations for many other biosupplier companies including its competitor company, Pall Corporation. Crux of the deal Merck will acquire all outstanding Millipore shares for $107 per share in cash, creating a world-class partner for the life science sector. Agreed transaction is valued at approximately $7.2 billion. Combination will create a $2.9 billion partner for the life sciences sector and transform Merck Chemicals Combined business will have significant scale in high-growth bioresearch and bioproduction segments Jahanara Parveen ]]> <![CDATA[Vaccine business to see uptake]]> https://biospectrumindia.com/news/95/1665/vaccine-business-to-see-uptake.html https://biospectrumindia.com/news/95/1665/vaccine-business-to-see-uptake.html Thu, 08 Apr 2010 11:38:00 +0530 The driving factor for the vaccine industry will not only be innovative technology, but addressing unmet needs in the area of infectious disease. A majority of philanthropic organizations like the Bill and Melinda Gates Foundation and the Wellcome Trust, are investing in vaccines for the developing countries-in the areas of  malaria, tuberculosis,  rotavirus and cancer. Research is already being conducted for a number of major infectious diseases, including HIV, HPV and hepatitis. While preventive vaccines have been the industry's focus, there is an increasing interest in therapeutic vaccines. â€œThe growth in the industry  depends on a breakthrough in therapeutic vaccines. The sale of therapeutic vaccines in developed markets and basic vaccines in emerging markets are likely to driveglobal vaccine sales in the near future,â€? says Rajesh Jain, MD, Panacea Biotec. Vaccines in the making Unlike pharma products, new undifferentiated vaccines do not struggle to compete with established market-leading brands, the market is such that if a new vaccine is able to become a second or third alternative, it can capture a good share in the market and earn good revenues. Ultimately, the challenge for pipeline developers is innovation in terms of safety, efficacy and compliance. This stimulates a lot of companies to enter into common disease segments like hepatitis, Japanese encephalitis, dengue, rota virus, rabies and swine flu. There is an extensive range of vaccines in the development pipeline undergoing various stages of testing and clinical evaluation in India. These include vaccines against bacterial diseases (tuberculosis, staphylococcus), parasitic infections like malaria, and viral diseases (HIV, rota virus, dengue). Most pose minimal risk in industrialized settings yet are prominent concerns in developing countries, stimulating private industry to engage in these markets. Rotavirus is responsible for hundreds of thousands of deaths annually in the developing world. Two live oral rotavirus vaccines-116E and I321 are in various stages of development in conjunction with vaccine manufacturers in India. Bharat has filed an IND for its rota virus vaccine. The product is currently in phase-III after successfully completing phase-I and phase-IIB studies. The company has invested  Rs 179-224 crore ($40-50 mn) in the clinical trials, with funding assistance from Gates Foundation. The vaccine will hit the market in 2011. The other company working in this area, Shantha Biotechnics, has started the phase-II clinical trial for rotavirus vaccine at Christian Medical College (CMC), Vellore. The company plans to start the phase-III in August 2010. â€œBy 2012 first or second quarter we will launch our rota virus vaccine,â€? says Varaprasad Reddy, MD, Shantha Biotechnics. The company is progressing with its plans to start the phase-I study of typhoid polysaccharide vaccine. Simultaneously, it is working on conjugated typhoid vaccine that is more effective with less side reactions. The vaccine is getting ready for trials. The other products in development include the pneumococcol vaccine and a HPV vaccine which is being developed in collaboration with John Hopkins University, is very close to entering the preclinical trials. The company hopes to finish all studies in four years and launch it in 2014. Shantha will get two vaccines from Sanofi-a hepatitis A vaccine and an acellular pertusis vaccine. Reddy says, â€œIf we get the IPV vaccine from Sanofi we will combine it with our pentavalent vaccine and make a hexavalent vaccine.â€? Bharat Biotech too has a strong pipeline of vaccines to combat malaria, typhoid and Japanese encephalitis infections. The malaria vaccine in development in partnership with International Center for Genetic Engineering and Biotechnology (ICGEB), is entering phase-I trials. â€œBharat Biotech is the only company working with four malaria vaccine candidates. We are also moving to specialized vaccines like rabies, Japanese encephalitis vaccine, chickungunya and staphylococcus aureas vaccine,â€? says Suchitra Ella, co-founder and joint MD, Bharat Biotech. Its conjugated typhoid vaccine is entering phase-III, is anticipated to reach licensure by end of this year. The most advanced product in Biological E's pipeline is a novel vaccine for Japanese encephalitis. Panacea Biotec's advanced pipeline include-Japanese encephalitis vaccine, dengue vaccine and the HINI vaccine for swine flu. Pune-based Serum Institute of India Limited (SIIL) will soon bring out India's first indigenously developed meningitis vaccine for meningitis. The vaccine, which has completed phase-I and phase-II/III testing in Africa and India, will be first introduced in Africa in this year after DCGI approval and WHO pre-qualification. The company has invested about Rs 80 crore in this project. The meningococcal conjugate vaccine will be better than the currently available polysaccharide vaccines and at Rs 22.48 ($0.50) per dose, will be about half or third of the cost of the polysaccharide vaccines currently available. The company is also working on Novel Drug Delivery System (NDDS) initiatives. At present several other vaccines are under development like the rotavirus vaccines and monoclonal antibodies for rabies. The other interesting products that Serum Institute intends to manufacture in the near future are bladder cancer vaccine and pneumococcal polysaccharide and conjugate vaccine. In addition to new vaccine development, research is ongoing in novel technologies to improve the delivery of vaccines so that administration can be faster, safer and more effective. This includes efforts to establish proof-of-principle in areas such as needle-free delivery (nasal, oral or transdermal) or heat stabilization. For example, preclinical studies have been successfully completed for aerosol delivery of measles vaccine, and phase-I-II trials are currently planned in India. H1N1 vaccine race hotting up The race for the locally made H1N1 vaccine is hotting up, as Indian swine flu vaccine makers are preparing to enter the final phase of trials before launching them. The final commercial roll out would depend on regulatory approvals. About one-third of novel vaccines in development by Indian companies are targeted at the H1N1 virus. â€œCurrently there are about 14 vaccines at various phases of development in India. Of these, 10 vaccines are innovative products while remaining are improved versions of available vaccines. About one-third of the new vaccines in development are targeted at the H1N1 virus,â€? says Gunnam. â€œAll the companies are gearing up for the launch of the H1N1 vaccine in India in mid-2010. Some players like Zydus Cadila and Biological E have entered into agreement with overseas players like Novavax and VaxInnate for the development technology, while Panacea Biotec has bagged a supply agreement from the Government of India. Apart from the Indian players, MNC players like GSK, Sanofi-aventis and Baxter, have conducted some bridge studies in India with their developmental swine flu vaccine, he adds. The government has already approved the use of Sanofi Pasteur's H1N1 influenza vaccine in India. Serum Institute's Fluvac will soon be ready for commercial use. The company is likely to receive regulatory clearances by the end of April. Serum has sought permission from the Drugs Controller General of India (DCGI) for the phase-III trials of the inactivate version of the vaccine. After Ahmedabad-based Zydus Cadila, Serum Institute becomes the second Indian company to have started phase-II/III trials, pushing it closer to the finishing line. Other vaccine makers, including Bharat Biotech, have completed phase-I clinical trials of their cell culture-based H1N1 vaccine candidate. HN-VAC is awaiting approval for the DCGI to go in for phase-II/III clinical trials. The report has been submitted to the DCGI and is currently awaiting the approval from the regulator to go for phase-III clinical trials. Zydus Cadila is currently in the middle of phase-II and phase-III trials. Panacea Biotec is developing PandyFlu (H1N1 vaccine) split virus vaccine using egg-based technology. It has also set up a BSL2 level manufacturing unit with BSL3 practices on its sprawling campus spread over 75-acre at Lalru, Punjab for manufacturing Pandyflu. The facility has a capacity to manufacture 4.5 crore doses of vaccine. Panacea Biotec, has been recently awarded financial assistance of Rs 10 crore under the Biotechnology Industry Partnership Programme (BIPP), initiative of the Department of Biotechnology (DBT) for the development of pandemic influenza vaccine. The firm had earlier also been given a grant of Rs 10 crore by the Ministry of Health & Family Welfare (MoHFW) for development and manufacture of the same vaccine. Commenting on the development Soshil Kumar Jain, chairman, Panacea Biotec says, â€œThe award of assistance by DBT for development of Pandyflu is a positive development for Panacea closely following the grant by MoHFW in connection with supply of Pandyflu vaccine.â€? Biological E is working closely with VaxInnate to rapidly develop and manufacture an innovative vaccine in India. The recombinant H1N1 vaccine is based on the novel Toll-Like Receptor (TLR) technology platform, which improves vaccine immunogenicity and efficacy. Using the TLR technology, vaccines can be produced by simple, low-cost, highly-scalable recombinant DNA techniques, avoiding many of the challenges and pitfalls of egg-based or cell-culture influenza vaccine production. Vaccine Industry Trends Exports presently account for around 65 percent of the country's vaccine market. The driver of vaccine industry's growth is new product development. Increasingly, vaccines are being aimed at adults, in addition to infants. Influenza vaccines and Hepatitis vaccines, with an estimated growth rate of over eight percent, are the fastest growing segments. Flu vaccines have huge demand at present and all major vaccine manufacturers are to develop the vaccine. While preventive vaccines have been the industry's focus, there's increasing interest in therapeutic vaccines. The use of a combination of vaccines is becoming more common. Vaccines comprising five or more ingredients are being developed. New ways of administering vaccines are under development including skin patches, inhalation, etc. M&A activity in the vaccine segment is likely to occur at a rapid pace. Vaccines being developed by Indian players Vaccine Company Status of Development Rotavirus vaccine Bharat Biotech Bharat Biotech, in collaboration with the Indo-American vaccine action programme, is developing a rotavirus vaccine for the prevention of diarrhoea. The vaccine will be entering phase III shortly. Rotavirus vaccine Shantha Biotechnics Has entered phase II trials. Cadi-05 Cadila Pharmaceuticals Cadi-05 is a Mycobacterium cancer vaccine for the treatment of hormone-refractory prostate cancer. Influenza vaccine Cadila Pharmaceuticals; Bharat Biotech Bharat Biotech and Cadila entered into a licensing agreement with Novavax in 2006 and 2009 respectively for the development of prophylactic influenza vaccine containing recombinant, functional influenza virus-like particles. Malaria vaccine Bharat Biotech; ICGEB Bharat Biotech, in collaboration with the Malaria Vaccine Initiative (MVI) at Program for Appropriate Technology in Health (PATH), the US, and the International Centre for Genetic Engineering and Biotechnology, India, is developing a malaria vaccine. H1N1 influenza (Swine flu) vaccine Bharat Biotech Bharat Biotech is developing a cell culture-based influenza vaccine. Will be entering phase-III. H1N1 influenza (Swine flu) vaccine Panacea Biotec It is an inactivated, split virion monovalent vaccine. H1N1 influenza (Swine flu) vaccine Zydus Cadila Zydus Cadila is developing an egg-based, inactivated vaccine against the H1N1 strain of influenza. It is the first Indian company to get DCGI approval for conducting clinical trials of H1N1 vaccine in January 2010. Plans to launch the vaccine mid-April. H1N1 influenza (Swine flu) vaccine Serum Institute of India It is an indigenous live attenuated H1N1 virus intranasal vaccine for the prophylaxis of pandemic H1N1 influenza. Has started phase II/III. H1N1 influenza (Swine flu) vaccine Biological E Biological E entered into a licensing agreement with VaxInnate Inc for clinical development and commercialization of its swineflu vaccine in India in January 2010. H5 N1 (Avian flu) vaccine Serum Institute of India The company received the contract for developing the avian flu vaccine in 2006 and later in August 2009, Serum has prioritized the development of swine flu vaccine. Malaria vaccine Bharat Biotech; ICGEB Entering phase-I. Conjugated typhoid vaccine Bharat Biotech Conjugated typhoid vaccine is entering phase-III, will be ready by end of this year. Jahanara Parveen in Bangalore ]]> <![CDATA[Leveraging Nanobiotech Applications]]> https://biospectrumindia.com/news/95/2165/leveraging-nanobiotech-applications.html https://biospectrumindia.com/news/95/2165/leveraging-nanobiotech-applications.html Thu, 08 Apr 2010 11:21:00 +0530 From enabling the delivery of engineered drugs to specific target tissues to multiple possibilities in stem cell research, nanobiotechnology is certainly the key to the future. Several    researches in nanobiotechnology are going on in various research institutes, but the lack of efforts in conversion of basic research to product development, remains the hurdle in India. â€œI think, we are still in infancy. Though nanocoated anti-cancer drugs like Doxil have been in clinical application in the US, we have not heard of any such breakthrough from India in the drug discovery field,â€? says Dr Samuel JK Abraham, director, Niche-in Center for Regenerative Medicine (NCRM), Chennai. Dr Anita Goel, CEO, Nanobiosym, says, â€œMedicine and nanomaterials may provide some of the first low hanging commercial fruits from nanotechnology. In medicine, for example, nanotechnology is enabling novel diagnostic as well as new approaches to therapy and drug delivery. In nanomedical diagnostics, I envision the impact of this technology to be somewhat similar to the cell phone industry. We saw a paradigm shift in the telecom industry when computing and communications devices became portable. Likewise, I believe that we will see a similar shift in healthcare when the ability to detect and diagnose disease can be taken out of pathological labs and put in the hands of doctors, nurses, and healthcare workers. Well, at least this is the motivation and vision behind our GeneRadar technology platform.â€? Another major impediment to the sector comes from the long wait for the regulatory approvals.  Therefore, the clear set of guidelines and regulator is required for this particular sector. Dr Jitendra N Verma, MD, Life Care Innovations, Gurgaon, says, â€œI really don't see much progress in the nanobiotech sector as far as commercialization is concerned. The conventional approach often leads to the hampering of approvals and sometimes the opinions may also be misguided. Eventually, this leads to the patent life being eaten up. The regulatory committees should understand this.â€? But, despite having a humble beginning, this technology is expected to replace the existing technology in a big way. Dr VK Tripathi, CEO, Virtus Technoinnovations, Mumbai, terms the nanobiotechnology as 'disruptive technology'. While citing reasons for using that term, he says, â€œThis is a very powerful technology that will revolutionize the entire industry, but, at the same time, it will upset the entire Rs 11.26 lakh crore ($250 billion) spa industry because of the cost-effectiveness that comes with it. It will certainly lead to replacing of the conventional methods by more effective ones.â€? Recent trends in research The researchers have exploited the unique properties of nanomaterials for various applications including cell imaging and therapeutics for treating cancer. The size of nanomaterials is similar to that of most biological molecules and structures; therefore, it is used for both in-vivo and in-vitro biomedical research and applications. The research by scientists at the Banaras Hindu University and the India International Advanced Research Center for Powder Metallurgy and New Materials has shown that silver nanoparticles show 'immense potential' in the prevention of blood clots. The scientists consider their discovery as an alternative to aspirin and other anti-platelet agents currently used to prevent blood clots in coronary artery disease, heart attack and stroke that often cause dangerous bleeding. Nanosilver appears to possess dual significant properties of being antibacterial and antiplatelet, with unique utilities. Virtus Technoinnovations has developed a patented technology on Gene Repair Therapy (GRT) to stimulate dormant genes in an attempt to cure diseases like cancer and AIDS. The company is the first in India to develop a resveratrol formulation having a half life of three hours, slow release from intestine and non-trace amounts of upto 53nmols/L. â€œIn one case we got even 40,000nmols/L of free resveratrol. Our formulation is a plant produce neither synthetic nor a plant extract and is free of heavy metals. We hence got a FDA manufacturing license as a nutrient product. Our excitement really rose because amongst large number of proven benefits of free resveratrol, one was that free resveratrol was toxic to cancer cells and protective to healthy cells during  in-vitro and in-vivo animal studies.â€? NCRM has successfully accomplished the in-vitro expansion of hematopoietic stem cells of human origin and from primates using such scaffolds. In the near future nanosurface coated human autologous fibroblast culture is likely to revolutionize the facial wrinkle treatment. At the moment conventional method of  fibroblast culture is used to support the facial anti-wrinkle treatment in Japan which is gaining popularity. NCRM is working on  enhancing the fibroblast culture work by using appropriate nanobiotechnology.  Another area of potential application will be in dental stem cells. In animal studies, corneal surface damages have been repaired using dental stem cells using temperature sensitive nano-coated surfaces. â€œNCRM is planning to take this to clinical studies. These proven applications using our expertise where in three dimensional culture of corneal limbal stem cells have been accomplished by our team jointly with Sankara Nethralaya,â€? clarifies Dr Abraham, Life Care Innovations is doing  pioneering work in developing nanobiotech products. The company has developed a nano drug for tuberculosis that is going to have global implications under the project funded by the Department of Science & Technology (DST), Government of India. â€œThe clinical studies have been completed and now we are waiting for  the Drug Controller General of India's approval.  The three formulations have been already approved and the fourth one is waiting for the approval,â€? informs Dr Verma. â€œThese studies were carried out in collaboration with the University of South Africa, and CSIR in South Africa. What makes this drug unique is that in comparison to the general DOT program where drug is taken everyday, it will have to be taken thrice a month only. The results of phase II clinical trial are awaited by the South African Medical research institute for the release of  the drug in their country,â€? adds Dr Verma. Mumbai-based NanoBio Chemical, which was founded in 2006,  focuses on nanobio applications in textiles and also the customized synthesis of complex peptides and biochemical solutions.  Biotech company Bharat Biotech is developing a novel topical oestrogen hormone replacement therapy and the New Delhi-based Panacea Biotec is working on novel drug delivery research using mucoadhesive nanoparticles. DNA is the natural nanoscale material that carries the genetic information. This quality makes it  an obvious choice for the researchers working in nanobiotechnology. Therefore, a lot of research is being done in this field by taking the DNA as the base molecule and the availability of novel techniques simplifies the study process. There have been many new developments related to nanobiotechnology applications in the field of diagnostics as well. The Defence Research and Development Organization (DRDO) has developed diagnostics tools for TB and typhoid, using nanobiotechnology. Gene-Radar developed by US-based Nanobiosym, is a mobile phone like device in which a small drop of blood, saliva or water is placed. The machine can then display what disease the person has. It detects signatures of DNA and RNA as well. The commercialization of Nanoxel, an injectible vial for dispensing the cancer drug paclitaxel, by Dabur in India and abroad has also opened doors to various possibilities. Nanoxel is a cremophor-free polymeric nanoparticle formulation of Paclitaxel with no hypersensitivity reactions, which allows administration to patients without pre-medication as is required with Cremophor paclitaxel. Revenue support The funding for nanotechnology applications is largely from DSIR, DST and DBT. The Nano Science and Technology Initiative (NSTI) by DST in 2001 under the leadership of Prof. CNR Rao allocated Rs 1,000 crore ($250 million)  for nanotechnology research from 2007. Also a Mission on Nano Science and Technology (Nano Mission) was launched in May 2007, to foster, promote and develop all aspects of nanoscience and nanotechnology, which have the potential to benefit the country. Recently in the budget for 2010-11, Indian government has increased the  funds for the Nano Mission from Rs 70 crore to Rs 100 crore. â€œAt the early stages when you are doing fundamental scientific research, government can be an ideal investor in promoting the basic science and technology agenda. As the innovation starts to get closer to commercialization, then venture capitalists and private equity players have a unique role to play to commercially scale up a technology and to capture market share,â€? opines Dr Goel. However, the lack of specific allocation of funds for the R&D in nanobiotechnology sector seems to hamper the growth of this sector.â€œThere is a need for the allocation of funds separately for nanobiotechnology and specifically for the product development and clinical trials. Then only we can see some visible progress in this field,â€? suggests Dr Verma. PPPs and nanobio products Nanobiosym is planning to set up multi-purpose nanotechnology innovation parks, the first-of-its-kind in India. Gujarat and Himachal Pradesh have signed MOUs with the company to establish the NanobiosymTech Park in India. While commenting on this Dr Goel says, â€œFor truly game changing technology platforms, I think the public-private partnership mechanism is an ideal way to bring disruptive technologies into market. For example, a developing country would have to spend huge amounts to develop its healthcare infrastructure to be at par with the developed world. But, by investing in game changing technology platforms like the cell phone or our Gene-Radar nanoscale molecular diagnostic platform, governments can drive technological change and leapfrog their healthcare delivery capabilities, because they do not have to build out the same overhead infrastructure that is required by the conventional technology platforms.â€? NCRM has been working on close to 240 different nanomaterials and technologies in specialties such as ophthalmology (corneal regeneration), orthopedics (cartilage injury repair), and hematology (expansion of hematopoietic stem cells). This has been made possible because it is an Indo-Japan joint venture organization and has an access to collaborators technological strength in terms of both nano products and processing methodologies. â€œThough we have got two projects funded by the government bodies through our collaborators; one with Institute of Pathology, Indian Council of Medical Research, New Delhi, and other with Sri Ramachandra University, we usually go for such fundings after filing IP rights,â€? shares Dr Abraham. â€œWe are also collaborating with public institutes such as IOP-ICMR, Anna University-KBC, and Tanuvas. But,  the PPP initiative in India has to be given more emphasis,  and it has to be result oriented as well,â€? he further adds. Life Care Innovations has partnership with PGI Chandigarh, Punjab University and IIT for the development of nanoliposomal drugs. However, Dr Verma feels the need for more partnerships between the academia and industry in this particular sector to get enough products in the market. â€œThe research going on in the academic and research institutes has not reached to the manufacturing stage and it gets lost there only due to lack of coordination between the public and private sector,â€? observes Dr Verma. Mumbai-based company, Nanocutting Edge Technology, has been doing a lot of innovative projects related to nanobiotechnology,  in partnership with Agharkar Research Institute, Pune. Nanobiotechnolgy is projected to play a critical role in patient-specific therapy; however, this transition will depend heavily on the evolutionary development of a systems biology approach to clinical medicine-based upon technology analysis and integration. As Dr Goel says rightly, â€œThere is certainly a lot of buzz out there about nanotechnology and thus one has the additional burden of proof to separate fact from fiction and the real applications from the far-off ones.â€? â€œI think, we are still in infancy. Though nanocoated anti-cancer drugs like Doxil have been in clinical application in the US, we have not heard of any such breakthrough from India in drug discovery fieldâ€? - Dr Samuel JK Abraham, director, NCRM, Chennai â€œThis is a very powerful technology that will revolutionize the entire industry, but, at the same time, it will upset the entire spa industry because of the cost-effectiveness that comes with it. It will certainly lead to replacing of the conventional methods by more effective onesâ€? - Dr VK Tripathi, CEO, Virtus Technoinnovations, Mumbai Rahul Koul and Jahanara Parveen ]]> <![CDATA[Tireless brains behind Bt brinjal]]> https://biospectrumindia.com/news/95/6694/tireless-brains-behind-bt-brinjal.html https://biospectrumindia.com/news/95/6694/tireless-brains-behind-bt-brinjal.html Thu, 08 Apr 2010 11:07:00 +0530 Dr Usha Zehr Barwale, chief technical officer and joint director of research, Mahyco An expert Geneticist, Dr Zehr has been the brain behind the development of Bt brinjal at Mahyco. Dr Zehr is the joint director of Research at Mahyco, India. She is responsible for research on plant biotechnology, technology transfer to farmers, utilization of new technologies and tools, including biotechnology for improving the quality and productivity of seeds and agriculture. Insect-tolerant or Bt brinjal expressing the Bacillus thuringiensis cry1Ac gene has been developed to reduce FSB pest-related damage in the brinjal crop, and increase farmers' profitability by way of increased marketable yield and protect the environment pesticides overuse. Ex-ante studies have indicated that deploying Bt brinjal would bring down the costs of cultivation of brinjal, as the contribution of chemical pesticides to brinjal cultivation costs is significant, and highest amongst vegetables in India. Dr Zehr says, â€œAfter receiving the biological material, plant transformation began at the Mahyco Research Facility. After the transformed plants were generated, high performing events were selected and these went into breeding program for transferring the trait to number of genotypes. At this stage, we also started our partnership with ABSPII, which included three public sector partners in India, two in Bangladesh and one in the Philippines. The technology was transferred to their chosen varieties.â€? â€œAll the regulatory guidelines were followed and all biosafety studies were conducted as stipulated. These studies all require the protocol for conduct of studies be approved by RCGM/GEAC before undertaking the study. All toxicity studies were conducted at third party, government approved facilities. Our team was engaged in the entire process of development of the product,â€? adds Dr Zehr. More on Dr Usha Zehr Barwale Dr Zehr received her MS (1985) and PhD (1987) in agronomy from the University of Illinois, Urbana-Champaign while working as a research assistant. She earned her BSc (Microbiology) in 1981 from Wilson College, University of Bombay and a diploma in clinical analysis from Sophia College, Bombay in 1982. Dr Zehr worked as a geneticist in the Sorghum and Millet Improvement Program at Purdue University, US from 1991-96. She serves on a number of boards such as the MS Swaminathan Research Foundation, Barwale Foundation, Sankara Netralaya and Donald Danforth Plant Science Center. She served as a member of the Technical Advisory Committee of the CGIAR in 1997-2002. She is a member of other committees such as the Private Sector Committee of the CGIAR, Intellectual Property Committee of the International Seed Federation, National Biotechnology Network, World Water Commission and Department of Biotechnology, Government of India. She is also director of the Mahyco Vegetables Seeds, Jalna. She has been involved in the founding or functioning of several charitable organizations such as Shri Ganapati Netralaya at Jalna, Maharashtra. Dr Ponnuswami Balasubramanian, principal investigator and former director, Center for Plant Molecular Biology, Tamil Nadu Agricultural University (TNAU), Coimbatore An eminent agri-scientist and expert, he was instrumental in evolving Bt brinjal with funds from DBT and USAID. The role of Dr P Balasubramanian involved the interfacing between his group at TNAU on one side and DBT and ABSPII (USAID) on the other. As per the MOU signed between Mahyco and TNAU, seeds of the target varieties were sent to Mahyco for crossing TNAU varieties with the Mahyco line harboring the EE1 event. Then the F1 seeds of the respective varieties were received by TNAU and backcrossing started at TNAU greenhouses using TNAU target varieties as recurrent parents. â€œThe idea was to select the best from among the backcross populations expressing the insecticidal protein at the required level while the original genetic backgrounds of the target TNAU varieties were retained as well. Theoretically, a population of BC3F2 (third back cross population selfed twice) would do for this purpose.â€? says Dr Balasubramanian While explaining his role, he says â€œI had to submit the reports on ongoing work to appropriate reviewing authorities at the university (Institutional Biosafety Committee) level and national (Review Committee on Genetic manipulation, Genetic Engineering Approval Committee, DBT Task Force Meetings) levels and international (ABSPII) levels. Awareness campaigns for public awareness had to be conducted with generous support from Biotech Consortium of India Limited and ABLE.â€? More on Dr Ponnuswami Balasubramanian Dr Balasubramanian is the former director of Center for Plant Molecular Biology (CPMB) and was involved in establishment of Rice Transformation Facility at TNAU in 1996 with financial support from the Rockefeller Foundation New York. DBT with its funding assigned him the work on cloning antifungal genes from Trichoderma spp. for use against Rhizoctonia solani, the invincible soil-borne plant pathogen. He has worked in evolving several transgenic lines of elite rice cultivars of Tamil Nadu expressing resistance to sheath blight and bacterial blight by pyramiding genes encoding a chitinase, a thaumatin-like protein and Xa21. He has built two Transgenic Greenhouse Facilities at TNAU with funding from the Government. of Tamil Nadu and DBT. His transgenic lines are awaiting clearance from DBT for field trials. He specialized in transgenic plant technology and molecular plant pathology and trained at University of California, Davis, John Innes Center, UK and the Scripps Research Institute, La Jolla, USA. He is currently engaged in evolving transgenic lines of papaya expressing resistance against papaya ringspot virus, evolving transgenic banana expressing enhanced shelf life using elite banana cultivars of Tamil Nadu. He is the editor-in-chief of a plant molecular biology journal published from Tamil Nadu. He is a member of the Institutional Biosafety Committees of the following research organizations such as, Sugarcane Breeding Institute, Coimbatore; Bharathidasan University, Thiruchirapalli; PSG Institute of Technology; Institute of Forest Genetics and Tree Breeding; Quinquiennial Review Team on Spices Research; and Tamil Nadu Biotechnology Board, Coimbatore. Maharashtra Hybrid Seeds Company (Mahyco), the Indian partner to American seeds giant Monsanto used a DNA construct containing the cry1Ac gene, a CaMV 35S promoter and the selectable marker genes nptII and aad to transform young cotyledons of brinjal plants. A single copy elite event, named EE-1 was selected and introduced into hybrid brinjal in Mahyco breeding program. Mahyco donated this technology to three institutes-Tamil Nadu Agriculture University (TNAU), Coimbatore; University of Agricultural Sciences (UAS), Dharwad; and Indian Institute of Vegetable Research (IIVR), Varanasi; and has made this technology available to small, resource-poor farmers for free. This was done to ensure the availability of technology and extend its benefits to the largest number of farmers. The major difference between the Mahyco's hybrids and that of the public institutions is that the farmers retain their rights to save their Bt brinjal OPV seeds for the next season. Bt brinjal was tested for four years at over 60 locations between 2004-08, with multi-location trials conducted by Mahyco, and independently by the Indian Council for Agricultural Research (ICAR) under the All-India Coordinated Research Program â€“ Vegetable Crops (AICRP-VC). Large scale trials were carried out in 2007 and 2008 under the supervision of the Indian Institute of Vegetable Research (IIVR). The results of the agronomic trials have indicated that in Bt brinjal crops show increased marketable yields by 71 percent over non-Bt counterparts. A 60-70 percent reduction in pesticide spraying for FSB control was recorded across the trials. This is reflected in the Economic Threshold Level (ETL) data for FSB, where ETL was crossed on an average of 0.94 times in the case of Bt brinjal plots, whereas this number ranged from 7 to 7.4 for conventional brinjal hybrids and varieties. Putting these benefits together resulted in a net gain of Rs 50,000-60,000 per hectare when Bt brinjal plots were compared to conventional ones. Bt Brinjal - The journey so far... 2000: Development of Bt brinjal at Mahyco. Brinjal transformation initiated at Mahyco.Gene: cry1Ac (B.t.k. strain HD73), nptII, CaMV35S promoter, construct from Monsanto and transformed by Agrobacterium tumefacians-mediated method. 2000-01: Lab and greenhouse evaluation for efficacy. 2002: Biosafety tests like pollen flow studies, were taken up along with back-crossing program into different hybrid parents initiated. 2004: Multi-locational field trials were conducted in 11 locations with five hybrids [Mahyco's MHB-4 Bt brinjal, MHB-9 Bt brinjal, MHB-10 Bt brinjal, MHB-80 Bt brinjal and MHB-99 Bt brinjal]. This was also the year when Indian Council for Agricultural Research (ICAR) took up trials with the same hybrids under the All India Coordinated Research Project on Vegetable Cultivation in 11 locations. 2005: Three more new hybrids were assessed by the company [MHB-11 Bt brinjal, MHB-39 Bt brinjal and MHB-112 Bt brinjal] and ICAR in the same year in 11 centers. 2006-07: After the permission of the GEAC, the extensive field trials were carried out in Karnataka, Goa, and Maharashtra at five places. Six popular varieties - Kudchi, Malapur, Udupi, Gulla, Rabakali, and Goa 112 - cultivated locally were modified genetically and used in the field trials. 2008: Pollen flow tests and extensive trials. 2009: Detailed compositional analysis. On Oct 14, Bt brinjal was cleared by GEAC for release. 2010: On Feb 10, it was put under moratorium by the government. Bt brinjal Event EE-1 contains three genes at a single integration site namely: The cry1Ac gene derived from Bacillus thuringiensis (Bt) which produces an insecticidal protein. The cry1Ac gene is driven by a viral promoter, the cauliflower mosaic virus (CaMV) 35S promoter. The Cry (crystalline) 1Ac protein (also called Bt protein) encoded by the cry1Ac gene belongs to a diverse family of insecticidal proteins with specific toxicities to certain groups of insects. This Bt protein encoded by the cry1Ac gene is highly specific to lepidopteran insects including fruit and shoot borer (FSB), which is a major pest of cultivated brinjal. The nptII gene which encodes an antibiotic resistance gene (also referred to as a marker), neomycin phosphotransferase, which allowed modified brinjal plant cells to grow in the presence of the kanamycin, and therefore be selected in the genetic engineering process, while inhibiting the growth of non-modified cells. It has no pesticidal properties. The aad gene which encodes another antibiotic resistance gene O-aminoglycoside adenyl transferase (aad). The aad gene is also a selectable marker but it is not expressed in Bt brinjal plants because it is under the control of a bacterial regulatory sequence that is not active in plants. Rahul Koul in Gurgaon ]]> <![CDATA[test23]]> https://biospectrumindia.com/news/95/2067/test23.html https://biospectrumindia.com/news/95/2067/test23.html Wed, 07 Apr 2010 17:14:00 +0530 test ]]> <![CDATA[BioSpectum turns 7- High Impact Trends]]> https://biospectrumindia.com/news/95/1134/biospectum-turns-7-high-impact-trends.html https://biospectrumindia.com/news/95/1134/biospectum-turns-7-high-impact-trends.html Fri, 12 Mar 2010 15:17:00 +0530 Bt cotton Being the only GM crop in India so far, Bt cotton has been a success story The approval of Bt cotton for commercial release by the GEAC at its 32nd meeting in 2002 marked India's entry into GM club. It also led to a great deal of hope, curiosity and expectations for the future success of agri-biotech sector in India. Initially frowned upon, GM cotton was a runaway success in India. The area under this crop and the number of farmers who adopted this technology increased significantly. The transgenic hybrids were developed by Monsanto's Indian partner- MAHYCO (Maharashtra Hybrid Seed Company). The introduction of Bt Cotton significantly brought down the annual losses caused by bollworms, estimated at about $300 million (Rs 1,384 crore). Also, it has helped in cutting down the repeated spraying of insecticides valued at $700 million (Rs 3,229 crore), 50 percent of which is sprayed on cotton crop alone. Despite the continued opposition by a small section, the Indian cotton farmers have accepted this technology in a big way and derived social and economic benefits. Human clinical trial for stem cells Recent approval of clinical trials of stem cell-based drugs by the Drug Controller General of India (DCGI) has created immense interest among global stem cell players to conduct their clinical trials in India Well-defined guidelines, efficient and speedy processes for approving clinical trials by regulatory bodies and availability of vast patient pool makes India a good destination for conducting clinical trials. ICMR and DCGI have drafted guidelines to conduct clinical trials in India in an ethical and scientific manner. ICMR has formed an expert stem cell committee to validate and recommend trials in India. DCGI recently made registry of all clinical trials mandatory with Clinical Trials Registry-India (CTRI) registry-so that all trials can be monitored for proper conduct as per international norms. Availability of skilled manpower and initiatives taken by the government in creating good infrastructure for stem cell research are attracting foreign institutes and private companies for collaborative research with Indian institutes and private companies. The initiative taken by the DBT in creating a world-class stem cell research center in Bangalore is another positive step in nurturing value-added stem cell research in India. India has the opportunity to be a global force in biotechnology and stem cell research can be an important constituent of this aspect of global leadership in this frontier technology area. First recombinant insulin and a vaccine The two indigenously developed recombinant products were real technology breakthrough not only for the companies who developed it but also for India In 1997, Shantha became the first Indian company to develop, manufacture and market India's first recombinant vaccine, Shanvac-B, a vaccine for hepatitis B. Shantha's entry into market with its hepatitis B vaccine (Shanvac-B) drastically brought down the prices of imported vaccine from Rs 780 to Rs 50 in 1997 and to Rs 25 in 2003. Wockhardt, a hospitals-to-drugs chain produced India's first recombinant human insulin- Wosulin-in 2002, making India the first Asian country to develop, manufacture and market the product. Those days, there were only three manufacturers of recombinant human insulin. With Wosulin, India gained reputation on the global map. With this indigenously developed insulin in the market, multinational companies had to cut their insulin prices in India by 35-40 percent in January 2003. National Biotech Regulatory Authority The drafting of a bill for the establishment of a National Biotech Regulatory Authority has been a major landmark in the history of biotech industry of the country In 2004, a single-window system for promotion and regulation in the form of National Biotechnology RegulatoryAuthority (NBRA) was proposed by a task force headed by famous agricultural scientist, Dr MS Swaminathan. This was seen as a major step towards generating the necessary public, political, professional and commercial confidence in the science-based regulatory mechanism in place in the country. Although awaited eagerly by the industry, the bill is yet to come up before the cabinet for approval. But now the recent announcements suggest that government is expected to push the bill through to the end of this year. An independent authority like NBRA will help regulate the large number of biotech related activities in the country. These activities include the vaccines, seeds, and biological products that require genetic engineering. The authority is expected to ensure that the biotechnology policies are strictly based on scientific assessment of risk. The need for a credible biotech regulator has been felt since last decade due to the lack of consensus on various issues related to GM technology. Biotech parks There has been growth in Bt parks in the country providing infrastructure to fuel the growth Establishment of Bt parks is an attempt both by the central and the respective state governments to bolster the R&D work and the infrastructure availability for the biotech industry. Over the past seven years, many states have taken up the biotech park initiative-especially the states of Gujarat and Andhra Pradesh. Gujarat is rapidly growing as far as Bt parks are concerned. The aim is not just to attract big players to the park but also to promote local companies. This includes The Akruti Gujarat Biotech Park which is a joint venture between the Gujarat government, The Chatterjee Group (TCG), and Akruti City Limited. It is also in the process of setting up an Agri-Biotech Park. Maharashtra is coming up with an International Biotech Park at Hinjawadi in Pune, a joint venture between Maharashtra Industrial Development Corporation (MIDC) and The TCG Real Estate and the Agri-Biotech Park in Jalna. Andhra Pradesh is one of the first states in the country to kickstart the BT parks strategy. Other states include, Tamil Nadu, Karnataka, Himachal Pradesh, Rajasthan, Uttar Pradesh and Chattisgarh. Recently, the Orissa Government commissioned a state-of-the-art Biotech Pharma IT Park, spread over 64.86 acres, at Mouza-Andharua, Bhubaneswar on a public-private partnership (PPP) mode. The park, the first-of-its-kind in Orissa envisages promotion of biotech, pharmaceuticals and IT industries in the state. The state government has recently selected Bharat Biotech International as the 'developer' for this prestigious project. Industry consolidation The industry gradually moved towards consolidation with an upswing in mega mergers, alliances and acquisitions The industry witnessed landmark convergence between pharmaceutical and biotech companies, not just globally, but even in India, thus paving the way for consolidation in the domain. A convergence between the pharma and biotech sector will gradually see both parties leveraging their strengths in drug development, commercialization, discovery and manufacturing capabilities thus delivering innovation and changing the whole landscape of M&A deals. Globally, Big pharma's acquisition spree started making big news since 2008. In January 2009, Pfizer acquired biotech big-wig Wyeth for $68 billion (Rs 3.12 lakh crore), followed by Roche ending its long drawn hostile battle with Genentech by buying the remaining 44 percent stake, thus acquiring the latter for $46.8 billion. This was followed by Merck's announcement in March 2009 to acquire Schering Plough for $41.1 billion (Rs 1.88 lakh crore). Other big deals include: Eli Lilly's purchase of ImClone Systems last year, Japanese giant, Takeda Pharmaceutical's acquisition of Millennium Pharmaceuticals and Cephalon's takeover of Australia's Arana Therapeutics. But the highlight was big pharma's growing interest in Indian companies. The landmark pharma-biotech deal being Sanofi-Shantha Biotechnics deal last year. Sanofi's vaccine's division, Sanofi-Pasteur, announced that it will pay â‚¬550 million (Rs 3,602 crore) for the Indian company. The former acquired ShanH, French subsidiary of Merieux Alliance, which holds a majority stake in Hyderabad-based Shantha. Similarly, Pfizer entered into an agreement with Aurobindo Pharma wherein the former acquired rights to 39 generic solid oral dose products in the US and 20 in Europe, plus an additional 11 in France. In a similar way, Pfizer also inked alliance deals with Ahemdabad-based Claris Life Sciences and Kolkata-based TCG Life Sciences. In a similar way, GSK and Dr Reddys' Labs entered into a marketing deal. First human genome sequencing in India A unique achievement in the field of science, the breakthrough paves the way for affordable healthcare and predictive medicine In December 2009, The Council of Scientific and Industrial Research (CSIR), India completed first ever human genome sequencing in India. With this achievement, the nation entered the league of select few countries like the US, China, Canada, UK, and Korea that have demonstrated the capability to sequence and assemble complete human genomes. This feat was unique in the sense that it was by a team of very young scientists. They finished the complete sequencing and assembling in much shorter time when compared to similar efforts elsewhere. The sequencing of the first human genome in India in conjunction with Indian Genome Variation program opens newer vistas for low-cost affordable healthcare and predictive medicine in future for the masses. This also opens up newer possibilities in disease diagnostics, treatment and sustaining low-cost drugs in the market. ]]> <![CDATA[Life Time Achievement]]> https://biospectrumindia.com/news/95/2062/life-time-achievement.html https://biospectrumindia.com/news/95/2062/life-time-achievement.html Fri, 12 Mar 2010 15:12:00 +0530 He made healthcare affordable, and not just in India but worldwide When Dr Anji Reddy talks pharmaceuticals, people listen. He proved to the world that pharmaceuticals can be a great business, that one can make money selling affordable drugs. Almost single handedly, he brought India the epithet of bulk drugs capital of the world. Dr Anji Reddy started Dr Reddy's Laboratories in 1984 and in 26 years, the company under his leadership has carved a niche for itself in generics, discovery of new molecules and patenting. The company has retained its focus on bulk drugs and provides raw material to a number of formulation manufacturers. Dr Reddy's Labs has become one of the largest Indian partner for global pharma companies, turning the Indian bulk drug industry from import-dependent in the mid-1980s to self-reliant in the mid-1990s and, finally, into the export-oriented industry that it is today. BioSpectrum goes back in time with Dr Reddy to bring you glimpses of his journey from a chemist to an entrepreneur with a passion for pharma. From student to entrepreneur As a student, he always found science fascinating and was academically excellent at school. â€œI used to have a lot of fun and never read much. I always had a very good memory so I would top my exams and my friends who played with me would fail,â€? confesses Dr Reddy. Dr Reddy spent his early years in the village of Tadepalli near Guntur in Andhra Pradesh, India where his father, a farmer, grew turmeric. Recalls Dr Reddy, â€œI grew up playing in turmeric fields and my first brush with technology in the form of electricity happened when I was 12 years old.â€? He completed his early schooling from the local high school and went on to earn his bachelor of science degree from Andhra Christian College at Guntur in 1958. Thereafter, he did his masters in pharmaceuticals and fine chemicals from Bombay University followed by a PhD in chemical engineering from the National Chemical Laboratory, Pune, in 1969. His career began in the state-owned public sector undertaking (PSU), Indian Drugs and Pharmaceuticals Limited (IDPL). But then, the entrepreneur in him took over. He decided to set up his own venture, Uniloids, in 1976. He later founded Standard Organics Limited, before founding Dr Reddy's Labs in 1984 with an initial capital from financial institutions. Shares Dr Reddy, â€œMy experience in IDPL formed the bedrock of my career. I came out of IDPL as early as 1973 with the objective of making new drugs for the first time in the country. I became an entrepreneur. I did not set upon an office, but, a laboratory. I kept moving from one laboratory to another making it better each time and today, I have one of the best laboratories in the world. I have one Integrated Product Development Organization (IPDO) which I refer to as Taj Mahal where 800 scientists work. It is one of the biggest laboratories in terms of the number of scientists,â€? he recounts with evident pride. For a man who has been at the forefront of Indian pharma evolution, through generics Dr Reddy is also a tireless crusader for intellectual property rights in India. Passion in pioneering drugs Dr Reddy is the pioneer of some of the very important compounds and drugs. These have proven to be vital in terms of affordability and availability for the common masses. The drug that he produced first is Metronidazole, which was better than the Italian product that India was importing at that time. The fact that he was making things, which were even better than the Western countries gave a boost to him. This confidence propelled him to move forward into newer areas. Later he also succeeded in making Sulphamethaxazole of higher standards. Then when he came out of partnerships and started Dr Reddy's Laboratories, made Methyldopa, which was the only drug available at that time for hypertension. Merck, a well known pharmaceutical company bought that product. Recalling his initial hardships and challenges, Dr Reddy says, â€œThere were many well-established pharmaceutical companies like Ranbaxy and Cipla at that time, which were in existence for a long time. In 1987, when I started my pharmaceutical brand it was very difficult for a new entrant to penetrate. So, how we made our place is an excellent example to the India pharmaceutical industry.â€? This chemistry's child went on to make newer drugs. An important one being Narfloxacin, an antibacterial drug which created an uproar in the pharma market and positioned his company high for all times. The drug, according to Dr Reddy, was much better than the versions of Ranbaxy and Cipla. The two companies that were then the Indian pharmaceutical leaders priced their products at $0.173 (Rs 8) while Dr Reddy's made the same drug at half the price making it affordable for all. Shares Dr Reddy, â€œThe only way to enter the market which is almost reserved for the existing players is to get down to a price where a common man can afford. We priced our drug at $0.0823 (Rs 3.80), chemists started returning stocks of Ranbaxy and Cipla and started buying our products. This forced them to bring down their prices.â€? â€œThe medical profession had recognized that if there is something called as affordable medicine it is Dr Reddy's who can do it. From that day onwards, the notion of affordable medicine was associated with Dr Reddy's Laboratories,â€? he adds. The passion of making newer drugs continued and Dr Reddy moved on to make a blood pressure drug, an anti-hypertensive and priced it at $0.0259 (Rs 1.20) while Merck was selling the same medicine at $1.2 (Rs 60). With a series of brilliant compounds and affordable pricing, Dr Reddy's Labs found its foothold as a strong pharmaceutical company. And 20 years later, the company has become India's number one pharmaceutical player. The other drug he pioneered is Ciprofloxacin. His company remained the only producer in the country for four years without any competitors. â€œI made a lot of profit during that time. I gave one bonus share for every two shares. The second year I increased it to one bonus share for every share and the third year I gave two bonus shares for every share. That is how I became the darling of the stock market in 1993,â€? he says. His company experienced a blazing growth rate from $108 mn (Rs 500 crore) in 1999 to $1.516 billion (Rs 7,000 crore) in 2009. â€œWhat kept us ahead of some of our competitors was having our own brands. A brand always earns more money than an API,â€? believes Dr Reddy. â€œOur entry into Russia also helped us tremendously. We consider it as our most profitable center. I am emotionally attached to Russia, they gave me the IDPL technology to start APIs. So, when the Russian market crashed, many left, but I stayed and today, we are the tenth largest pharmaceutical company there,â€? he adds. Major milestones Dr Reddy's Labs was the first company to take up drug discovery research in India in 1993. April 2001, the company also became the first Asian pharmaceutical company outside Japan to be listed on the New York Stock Exchange (NYSE). It is worth mentioning that it was also the best performing company on NYSE. â€œWe are also the first company to do authorized generics in the US along with our partner Merck for two products,â€? shares Dr Reddy. This generics pharma czar does not mind being called 'copy cat'. He happily says, â€œYes we are copy cats and there is nothing negative about it. The government allows us to do it, it is not illegal. We are definitely not innovators. But we are the ones who have cut the cost of pharmaceutical substances making it affordable world over. The big pharma who call us copy cats, they too manufacture and market generics. They also fight patent challenges with other innovator companies.â€? Ups and downs Dr Reddy's Labs has led the industry from being dubbed as copy cats for several years to now being acknowledged as innovators. Dr Reddy says, â€œIf you want to be a world-renowned pharmaceutical player you should have your own discovered product in the world market, at least one to start with.â€? India changed its patent laws, the Indian Patent Act of 1970 was passed. Product patents for medicinal products were no longer recognized and only process patents continued to be recognized. The pharmaceutical industry in India grasped this opportunity with both hands and proved dramatically that its reverse engineering skills were second to none in the world. â€œWhile everyone was pre-occupied feasting on this opportunity, in 1992, I started thinking in a different direction-with 25 years of experience in synthesizing a plethora of drugs I made up my mind and took the plunge in November 1993. We jumped into discovery with a budget of about $1.40 million (Rs 6.5 crore),â€? he shares. And in three years from inception, Dr Reddy discovered one of the most potent glitazones and licensed the molecule now called balaglitazone to the world leader in diabetes, Novo Nordisk of Denmark. Balaglitazone is a partial peroxisome proliferator-activated receptor (PPAR) gamma agonist and phase II results indicated a better side effect profile than the existing glitazones. â€œMore than the molecules that we discovered, the big difference we made is that we have gained recognition from the world that we are the front-runners in the field that we have chosen. The mission is to make healthcare affordable and improve the quality of life across the world, regardless of geographic and socio-economic barriers,â€? he says. Investing for Social Change Twelve years ago he began the important journey of connecting with society and taking responsibility for human development apart from sustaining a profitable and competitive business. Years later, Dr Reddy has built a benchmark model in this area as he continues to engage himself with sections of society that experience poverty and the lack of opportunity to access sustainable livelihoods. Dr Reddy is no longer involved in the day-to-day operations of the company. He spends more than half of his time on philanthropic activities. And it's not just time that he invests. He has been spending a bulk of his earnings to fund initiatives to alleviate hunger, create livelihoods, provide education and access to safe drinking water and pull back children from hazardous industries through his not-for-profit organization-Naandi Foundation. He has set a target of transforming a million lives by the end of 2010. It is also with this perspective that Dr Reddy founded Dr Reddy's Foundation in 1996 to pursue causes close to his heart. The Foundation is particularly active in the field of creating livelihoods. Its initiative, called Livelihood Advancement Business School or LABS, has, so far, trained over 130,000 youngsters with skills suited for entry-level jobs in sectors such as hospitality, ITES and customer relations. Dr Reddy has committed a huge amount of fund for over 10 years that will make the L V Prasad Eye Institute self-sustaining. LV Prasad Eye Institute does a lot of free and subsidized eye treatments. The institute is the only one in India and one of the few in the world that uses stem cells for corneal reconstruction. It has treated over 500 such cases over the last five years, the highest anywhere in the world. He also launched a social initiative called â€œSparsh,â€? an assistance program for cancer patients who cannot afford a treatment. Patients identified by the doctors through Sparsh are provided Reditux, the anticancer biologic drug from Dr Reddy's Labs free of cost. He is also the man behind the Institute of Life Sciences (ILS). The institute focused on the interface between life sciences and chemistry. Here, chemists and biologists work together to seek solutions to human health issues. The model is to create its own intellectual property and commercialize it in collaboration with the industry. â€œThese philanthropic activities keep me going and help me stay connected to the societyâ€?, he says. He confesses, â€œI am always inquisitive. So if I had become a chemist, I would have been a journalistâ€?. As a person, he likes seeing different places and knowing people. â€œApart from pioneering drugs and running a business house I am also good at guessing a persons' origin by the way he/she speaks English,â€? he laughs. 25 years of Innovation In February 2009, his company completed 25 years of its life. â€œIt is a significant milestone. We have grown from a small establishment located in Hyderabad to a strong global company with facilities in India, Europe, the USA, Russia and China-earning a net revenue of $1.37 billion in 2008-09,â€? he shares. â€œI am happy with the way we have grown over the years. But I am happier still with the fact that, throughout the growth process, the company has never forgotten the basic reason for its existence-to provide affordable and innovative medicines to patients across the world. And that it has the-strategy to leverage research and development, product offerings and customer services to be a leading global pharmaceutical company,â€? he says. The history of pharmaceuticals in India is a story of this bold entrepreneur whose pioneering efforts demonstrated that he could master processes that could be used to manufacture chemicals and molecules that would help India progress towards a sustainable twenty-first century. The story of Dr K Anji Reddy is thus all about the ability to chase a dream and make it come true. Jahanara Parveen in Hyderabad ]]> <![CDATA[OutBound Japan industry on the move]]> https://biospectrumindia.com/news/95/2092/outbound-japan-industry-on-the-move.html https://biospectrumindia.com/news/95/2092/outbound-japan-industry-on-the-move.html Fri, 12 Mar 2010 15:04:00 +0530 Japan is the world's second largest economy and also the second highest spender in healthcare in the world. A rapidly aging population has burdened the healthcare system both in terms of funding and facilities there. For life sciences companies globally, the massive size of the Japanese market is a considerable attraction. This gives Japan a distinct advantage over other countries in the region such as Australia, Korea and Singapore, where the industry is limited by their comparatively smaller domestic markets. The last decade has seen the Japanese pharmaceutical players ranking in the top list of global pharmaceutical manufacturers. And in a bid to perform more competitively on the world stage, some of the biggest Japanese companies have merged to form Astellas Pharma, Dainippon Sumitomo and Daiichi Sankyo. According to Japan Pharmaceutical Manufacturers Association, the global pharmaceutical market approximately doubled to $565.9 billion (Rs 26.19 lakh crore) between 1995 and 2005. Japan became the second largest market after North America, with a market size of over $111 billion (Rs 5.13 lakh crore). A breakdown of these sales indicates that prescription drugs consumed in Japan accounted for 64.4 percent of the market and exports of prescription drugs to other countries accounted for 15.8 percent. Thus, prescription drugs accounted for the bulk of the market. As a result of decrease in drug prices in recent years, growth of the Japanese pharmaceutical market has been somewhat curtailed. Consequently, expectations are high for overseas markets, particularly the US, EU, China, India and other markets that are rapidly growing. According to a Business Monitor International (BMI) report, generic drugs account for less than 10 percent in Japan market. While China and India account for 65 percent and 37.1 percent respectively. However, BMI forecasts that the market share for these low-cost products in Japan will double by 2010, adding almost $5 billion (Rs 23,142 crore) in value to the sector. The government too has implemented a generic substitution system to increase the market share of generics to 30 percent in volume terms by 2012. In 2009, generic companies such as Sawai Pharmaceutical, Towa Pharmaceutical and Nichi-Iko announced plans to introduce their versions of a number of blockbuster drugs whose patents expire this year. Foreign entrants to the generic market, such as Israel's Teva, which formed a joint venture with Kowa Pharma, are planning a more aggressive strategy that will involve marketing around 200 generic drugs by 2015. In June 2009, the Pharmaceutical Affairs Law was also revised and the rule in regards to the sale of over the counter (OTC) drugs was relaxed. The relaxed rule has resulted in increased competition in the sector with reports of supermarkets and convenience stores reducing prices by up to 20 percent. Additionally, various industrial policies have been drawn up and implemented that include 'Pharmaceutical Industry Vision', Biotechnology Strategy' and 'Intellectual Property Strategy', but many issues, including drug pricing system reform and consolidation of the clinical trial system remain unresolved. Giving importance to the IP scenario, the government is very supportive in intellectual property. It has been laying more emphasis on increasing the number of patent attorneys specialized in the areas of life sciences and biotechnology. Major universities have liaison offices for technology transfers. Even the education ministry has been providing funds for intellectual property issues so as to support the university professors to file patents through foundations set up at the universities. Biotechnology-a leading sector The Japanese biotechnology industry too has been making good progress in recent years. Much of the impetus has come from the Japanese government which has been providing considerable support to foster this industry. There are about 400 biotechnology companies in Japan. But the core biotech companies are about 100 that are doing very well in the stock market. The big pharmaceutical companies own these companies which have a diversified product range. Besides the leading companies, there are about 10â€“15 spin-off companies from the universities. To remain stable, these companies have opted for the services model. They are utilizing a part of their resources for the product development as a long-term goal. The industry's rapid development is a visible result of the close cooperation between the Japanese public and private sectors and academia. In 2007, the total market size of the Japanese biotechnology industry was $19.5 billion (Rs 90,247 crore), a 10.8 percent increase over 2006. Biopharmaceuticals continue to be the mainstay of the Japanese biotech market, accounting for 40 percent of the total market. Recombinant protein drugs such as erythropoietin and interferon have the highest market share in the biopharmaceuticals segment. Erythropoietin, the largest selling product with a market size of around $1 billion (Rs 4,628 crore), is expected to show continous growth. Although most of these biopharmaceuticals are produced in technical collaboration with European and American companies, Japanese biotech companies are now investing heavily in research to bring out their own products and are eying various emerging areas. Regenerative medicine, which promises to grow organs and tissues to eliminate the problem of rejection that occurs with organ transplants, holds much interest for Japanese companies. The other potential areas of growth are expected to be protein drugs and glycobiology. Currently, medical biotechnology is the leading sub-sector in Japan. Medical biotechnology products account for over 30 percent of the Japanese biotechnology market. Within medical biotechnology, therapeutic antibodies have the highest growth potential. Japanese pharmaceutical companies are eagerly seeking new drug candidates and pipelines, identified or developed by overseas biotech companies, which they can tap into in order to develop new drugs. The restructuring and change From 2008 onwards there has been a spate of mergers and takeovers, involving both foreign and local companies. Japan's acquisitions market has seen surprising growth in recent times, as generic drugs increase in popularity. Companies like Daiichi Sankyo, Eisai, Astellas Pharma and Takeda have been aggressively expanding their global operations. The business integration from 2005 to 2007 of the two separate companies to form the joint Daiichi Sankyo created one of Japan's biggest pharmaceutical companies. Daiichi Sankyo's move to acquire India's top drug maker by revenues, Ranbaxy, is one of the biggest outbound M&As so far, with a deal worth $5,326 million (Rs 24,651 crore). In the past, new drug companies like Takeda and Sankyo did not have to care about generic drugs, but now, for example, Daiichi's Ranbaxy buy puts it onto the global generic drug market map. The move, which came in June 2008, also gives Japanese drugs maker Daiichi Sankyo a foothold in the US and Indian market. The other biggest outbound deal in recent years is the Osaka-based Takeda's acquisition of Massachusetts, US-based Millennium Pharmaceuticals in 2008, a buyout worth $8.8 billion (Rs 40,730 crore). Takeda is the largest pharmaceutical company in Japan and its patent on stomach acid reducing drug Prevacid expired in November 2009 and while diabetes drug Actos is losing patent in 2011. As Japanese companies become global forces, a key challenge is to integrate Japanese personnel with workforces overseas. Takeda Pharmaceutical last year reorganized its corporate structure, as part of its 2006-10 Medium-Term Plan vision to become a global pharmaceutical company with highly integrated global operations. In order to become more responsive to rapid changes in the global operating environment and to maximize the global market potential of new products and the company's global presence, the company is streamlining executive reporting relationships to Yasuchika Hasegawa, president, by creating corporate-level, center of excellence R&D, commercial and administrative functions. â€œTakeda is making meaningful changes in structure and governance through this reorganization and the creation of the CSO, EVP, International Operations, and CAO roles, which we believe will further strengthen our global operations structure,â€? Hasegawa said, in a company release. The company is also setting up new commercial subsidiaries covering Mexico, Turkey, Sweden, Norway, Denmark, Belgium and Luxembourg as part of its strategic global expansion effort. The new subsidiaries will strengthen Takeda's expansion efforts for products such as Actos (pioglitazone), which the company bought back in October 2009. For most of the leading Japanese pharma players, overseas business comprises 45 to 60 percent of their revenue. For Astellas, overseas sales for FY08 was 48.6 percent and for the second quarter of FY09 it was 49.5 percent. â€œAstellas' sales results for FY08 stood at $10.53 billion (Rs 48,731 crore), while our forecast is $10.64 billion (Rs 49,245 crore) (+1.1 percent). We plan to formulate a new five-year medium-term management plan to begin in FY2010 ending March 31, 2011. The scheduled announcement for the plan is May 2010. Therefore we are unable to provide the envisaged future growth,â€œsays a senior spokes person from Astellas Pharma Japan headquarter who did not wish to be named. Sharing information about the regions providing better growth rates for Astellas, the person quotes, â€œWe had good sales performance in Japan, Asia, the US and EU on each currency basis in FY08. In addition, we are focusing on emerging market as well. We established our affiliates in India in November 2008 and in Brazil in July 2009.â€? Eisai too seems to be on a globalization spree. The company acquired two US companies in recent years-Morphotek in 2007 and MGI Pharma in 2008. The company went on setting up two knowledge centers 2009-one in Europe and the other in India. The India facility, which is an investment of $50 million (Rs 231.41 crore), is the second facility after Japan that will cater to the global market. The facility, which is scheduled to start full scale operations by September 2010, will be Eisai's first base to integrate active pharmaceutical ingredients (APIs), formulation manufacturing and API process research on one site. According to Sanjit Singh Lamba, president, Eisai Pharmatechnology and Manufacturing India, â€œWe are operating a globalization strategy. This new facility would emerge as the global hub for R&D, formulations and API manufacturing. The center is aimed at stimulating the knowledge creation between the researchers and the production team.â€? Eisai has production facilities in Japan, UK, the US, China, Taiwan, Indonesia, and R&D facilities in Japan, UK and the US. Therefore, after years of indifferent performances and an expiring product pipeline, the Japanese industry is on the move. The mergers, acquisitions and globalization strategies are an indicative of a corporate restructuring which has fundamentally changed the Japanese industry. Many see the future for the Japanese companies as that based on innovative R&D and in export markets. In a ranking of pharmaceutical companies that developed the top 100 products in terms of global sales, Japanese-based firms today are in the third position after those of the US and UK. Jahanara Parveen in Bangalore ]]> <![CDATA[BioAsia 2010: A forum for partnership]]> https://biospectrumindia.com/news/95/1907/bioasia-2010-a-forum-for-partnership.html https://biospectrumindia.com/news/95/1907/bioasia-2010-a-forum-for-partnership.html Fri, 12 Mar 2010 12:31:00 +0530 The event took a more serious approach, focused on issues relevant to immediate business The seventh edition of the annual biotechnology conference, BioAsia 2010, the global biobusiness forum was held from February 3 to 6, 2010, in Hyderabad. The four-day BioAsia 2010 conference was inaugurated by K Rosaiah, chief minister of Andhra Pradesh. After inaugurating the event he announced that top biotechnology companies are ready to invest up to Rs 1,000 crore to create infrastructure for the plug-and-play lab in the third phase of biotech park in the state. He said, â€œOn behalf of the state government, I assure full cooperation to the investors in biotech industry to come out with innovations and investments in the area of biotechnology not only in generating products but also in research and exploration of new avenues for the benefit of people.â€? Some of the prominent people present at the event were Prof. Seyed E Hasnain, chairman, BioAsia 2010 Advisory Board and vice chancellor of the University of Hyderabad; Dr MK Bhan, secretary, Department of Biotechnology, Government of India; Kanna Lakshmi Narayana, minister of major industries, Government of Andhra Pradesh; Joseph Huguet I Biosca, minister of innovation, Catalonia Government, Barcelona; Joel S Marcus, chairman and CEO, Alexandria Real Estate Equities, US; and Dr Maive Rute, director general, European Commission, Brussels. Jointly organized by the Federation of Asian Biotech Associations (FABA), State Government of Andhra Pradesh, University of Hyderabad, and All India Biotech Association (AIBA); BioAsia had the participation of over 2,000 delegates this year. The annual event provided the opportunity for showcasing the initiatives taken in Andhra Pradesh to create worldclass life science clusters in Genome Valley and in various parts of the state. BioAsia, which is one of the largest biotech and life sciences event in South Asia, provided a platform for biotech companies to network, display their technologies, and interact with the delegates. The event this year had the presence of delegates and companies from over 30 countries including North America, Europe and Asia. The event comprised four tracks and 24 technical sessions covering the areas of medical biotechnology, biopharmaceuticals, agribiotechnology and animal biotechnology. Apart from the conference sessions, the event closed with about 500 B2B meetings. The other highlight of this year's edition were Indo-European networking meetings, white papers on PPP in biotechnology and funding options for drug discovery. Delivering his lecture, Dr MK Bhan, said, â€œBioAsia is an example of how connectivity can be built with companies and people coming from different parts of the world.â€? He stressed that the field of biotechnology needs technologists driving entrepreneurship. He stated that the Indian government has been increasing its science budget by 30 percent each year and DBT has funded more than 120 companies in the last 12 months. The next edition of BioAsia is scheduled for February 21-24, 2011, in Hyderabad. Highlights of BioAsia 2010 Genome Valley Excellence Awards Recognizing the need to reward the stalwarts in biotech, BioAsia presented Genome Valley Excellence Awards to Dr CR Rao, director, Center for Multivariate Analysis, Pennsylvania State University, US, for his research contribution to statistical methods to understand health and disease and Janet Thornton, director, EMBL European Bioinformatics Institute, Cambridge, UK, for her outstanding contribution using computational methods for understanding protein structure and its function. Alexandria Center for Science and Innovation The Chief Minister unveiled the plaque to mark the inauguration of Alexandria Center for Science and Innovation in Genome Valley, where the company wants to invest Rs 500 crore in the biotech cluster. The proposed center, to come up in phase III of biotech park would provide worldclass plug-and-play lab space for biotech companies. CEO Conclave calls for re-evaluating business models The CEO Conclave held as part of the seventh edition of BioAsia, leaders of the Indian biotech industry discussed about the ways to gear up the Indian biotech industry to face the global challenges. Sandeep Gupta, managing director of Eli Lilly India, said, â€œBiopharma companies are exploring various outsourcing and partnering models. Bigger MNCs like Eli Lilly have changed their model from fully-leveraged pharmaceutical model to collaboration models, especially for a market like India. The small biotech model is now being emulated by big pharma to reinvigorate R&D in several ways.â€? Dr Rajesh Jain, managing director, Panacea Biotec, said, â€œMoney is not the only issue in innovation. The bigger pharma giants have a drying R&D pipeline and productivity. We need to leverage human minds not resources. We have to be innovative in a more innovative manner.â€? The other common points that came out in the discussion were-need for platform technologies, a model based on risk and reward sharing, focus on biologics, creation of autonomous R&D units and creative funding approaches leading to newer business models. Medical devices cluster in Hyderabad Andhra Pradesh will set up MedTech Valley, a worldclass cluster for manufacturing medical devices and equipment near Genome Valley at Shameerpet in Hyderabad. The state government will provide 1,200 acres of land for the project. In the first phase, 200 acres are being developed by the Hyderabad Metropolitan Development Authority. The project will be executed by a public-private partnership model and will get assistance from the Center for Infrastructure Development. Jahanara Parveen in Hyderabad ]]> <![CDATA[Bt brinjal put on hold for now]]> https://biospectrumindia.com/news/95/2366/bt-brinjal-put-on-hold-for-now.html https://biospectrumindia.com/news/95/2366/bt-brinjal-put-on-hold-for-now.html Fri, 12 Mar 2010 12:24:00 +0530 As widely expected, the government has imposed a moratorium on the introduction of India's first genetically modified (GM) food crop, a Bt brinjal hybrid, developed by Maharashtra Hybrid Seed Company(Mahyco). Environment Minister, Jairam Ramesh, made the public announcement about the move to put on hold the commercial approval granted to Mahyco's Bt brinjal hybrid, using a cry1Ac gene extracted from a soil bacterium, bacillus thuringiensis, to induce resistance to a major pest, foot and stem borer which damages more than 40 of the crop by its attacks. This decision on moratorium, after the pathbreaking approval granted to it by the biotech regulator, the Genetic Engineering Approval Committee (GEAC), on October 14, 2009, has sent shock waves through the industry and jubilation among the anti-GM coalition of civil society groups. While announcing his decision on February 9, 2010, Jairam Ramesh said, â€œIt is my duty to adopt a precautionary principle-based approach and impose a moratorium on the release of Bt brinjal till such time independent scientific studies establish to the satisfaction of both the public and professionals the safety of the product from the point of view of its long-term impact on human health and environment.â€? It has been clarified that the current moratorium is only on this specific Bt brinjal hybrid and not on the GM food technology itself. Ongoing trials and research work on various GM crops could continue, the minister clarified. The minister faced strong opposition from his Cabinet colleagues handling science and technology, agriculture and other senior members. So the Prime Minister, Dr Manmohan Singh was forced to intervene and convene a meeting of these warring ministers and nudge them towards a consensus. This important meeting was held on February 24, 2010. The meeting could not resolve the issue amicably. However, it gave a lease of life to the long pending legislation to set up the National Biotechnology Regulatory Authority (NBRA). A statement issued by the Prime Minister's Office (PMO) after the February 24 meeting said: â€œIt was agreed that biotechnology is an important option for higher agricultural productivity and ensuring food security. At the same time, we must ensure that it has no adverse effects on human and animal health and bio-diversity.â€? â€œKeeping this in mind, the government will soon be moving forward in setting up a National Biotechnology Regulatory Authority, which will inspire confidence and stimulate public and private investment in biotechnology,â€? the PMO statement said. The meeting came after the issue on Bt brinjal moratorium was raised by the Agriculture Minister, Sharad Pawar who had written to the Prime Minister, earlier this month. Pawar had written that moratorium had 'confused' the scientific community and the private sector about the status of biotechnology in food security and about the deciding authority. The statement issued by PMO also clarified that the Genetic Engineering Approval Committee (GEAC), would continue to remain as the body to address concerns for resolving all scientific issues relating to Bt brinjal including safety aspects. The meeting also stressed the need to create confidence amongst states about the role of biotechnology in food security. The proposal to set up NBRA was mooted in 2004 based on the reports of two task forces on biopharma (headed by Dr RA Mashelkar) and bioagriculture ( Dr MS Swaminathan). However, the draft legislation has been circulating within the government for over five years due to lack of consensus between the various ministries and regulators involved in handling biotechnology. Now, with the Prime Minister's public statements, the NBRA bill is likely to get a smoother passage within the government. In early February, the NBRA bill was referred by the Cabinet Secretary to a committee of secretaries (COS) for the final word. According to Dr MK Bhan, secretary, Department of Biotechnology, the draft bill will be ready to be sent to the Cabinet for approval. The long wait for NBRA bill could finally be over. Experts speak... â€œThe real losers are not just scientists who were responsibly for developing technology for the last many years, but actually farmers who could have enormously benefited from this technology. The Environment Minister has given himself to sentiments rather than science and scientific logicâ€? - KK Narayanan, managing director, Metahelix Life Sciences â€œI wanted a moratorium on all GM crops for the next 5-8 years till the time there is reliable scientific data from the Indian scientific community â€“ so that has happened. Now a network of indigenous labs should be set up where the technology should be tested on our home conditionsâ€? - Dr PM Bhargava, independent observer appointed by the Supreme Court to the GEAC â€œWe need a regulatory mechanism that inspires data confidence. There are concerns about whether all tests have been done, and whether there has been an independent verification of results submitted by a company. In food items of life-long consumption, chronic toxicity tests should be conducted on animals. There is need for a regulatory body with independent facilities for testingâ€? - Dr MS Swaminathan, eminent agriculture scientist â€œWe are not against the use of genetically modified technology to improve crop yields. But we oppose the introduction of Bt brinjalâ€? - Sunita Narain, director, Center for Science and Environment BioSpectrum Bureau ]]> <![CDATA[7 Roadblocks]]> https://biospectrumindia.com/news/95/1169/7-roadblocks.html https://biospectrumindia.com/news/95/1169/7-roadblocks.html Mon, 08 Mar 2010 15:42:00 +0530 Human resources Industry suffers from lack of skilled people, affecting innovation India has over 400 biotechnology colleges from where annually over 15,000 students graduate, however, not all of them are employable. The number of biotech graduates in India has increased to 15,000 in 2009 from a paltry 1,000 in 2003 and this shows the interest students have in biotechnology. The demand for manpower in biotech ranges from scientists, researchers and technicians to the sales personnel, legal teams and teachers. There are over 100 public colleges and over 300 privately-owned biotech colleges in India. Over the years, BioSpectrum has interacted with various CEOs and HR executives in biotech companies to look into this aspect, and now it is known that the average employability of graduating students in the country for the Indian biotech sector was just 22-25 percent. Lack of practical knowledge and hands-on experience imparted to students at educational institutions can be one of the reasons for this dearth. Quality thus becomes a crucial factor for such a specialized industry. Being a knowledge intensive sector it requires highly-skilled manpower. It is for this reason that biotech students think it is appropriate to study abroad, acquire higher degrees and specialization to get better exposure in terms of salary and growth. Technology access Constraints limiting researchers' access to vital technologies Indian scientists have difficulties accessing information and participating in knowledge networks. They also have very limited access to efficient utilization of high-end platform technologies. If Indian scientists have to grow up to world-class levels, India needs to create physical infrastructure in critical platform technologies. These should be used to support disciplinary and interdisciplinary education, training and research in biotechnology. Platform technologies facilitate a broad range of application-based activities. Access to appropriate platform technologies can reduce costs and avoid unnecessary duplication of facilities, increase international R&D competitiveness and provide an environment of effective networking and collaboration. Innovation ecosystem Building the right innovation climate is critical to the innovation process India lacks an innovation ecosystem that can drive the country's development over the next decade. Innovative solutions that are developed in several research labs with potential are not nurtured and rapidly applied. Research institutions must promote an innovation culture. Their research goals should be aligned with the expectations of the industrial and social sectors. Scientific institutes should also improve their outward orientation by strengthening links with industry and increasing international research partnerships. Different types of policy measures are also needed to create a climate favorable to innovation. Along with policy measures there is a need for local structures such as incubators and innovation centers which help entrepreneurs developing their projects. The development of a venture capital industry is equally important. It is needed in the later part of the innovation process when projects have to be scaled up at the production and commercialization phase. Lack of seed funding VCs and PEs are risk averse Unlike other industries where gestation period and time to market is less, biotech industry is a time and capital-intensive industry. A product development can take anywhere between 5-10 years and has a massive cost involved and this puts off venture capitalists and private equity firms who cannot risk loosing money when a product fails. While this is the case in India, abroad, especially in western countries, VCs invest seed money into a startup. India has numerous firms ready to pool in late stage funds of a product cycle but there is a dire need for startup funding in the country. Industry experts attribute this to the lack of awareness amongst investors about the complexity and technicalities of the industry. The long drawn gestation period in a product cycle is another reason for VCs and PEs being reluctant, as it does not bring about quick RoI. Barring a handful of firms that have a dedicated team for life sciences and have allocated separate investments for this sector, there are many firms for whom the sector remains in the periphery of their priorities. Investors on the other hand claim that there is a lack of innovation in the country. This is a stark contrast to funding firms in North America and Europe where team members are veteran biologists and have had hands on experience of the industry. Spirit of entrepreneurship has not caught on Entrepreneurs look at quick RoIs which is why biotech does not appear to be their preferred choice Biotech in India might be picking up but a lot depends on investments not just by funding firms but on the willingness of the new age well informed entrepreneurs opting for this sector. India has definitely brought out some successful entrepreneurs like Dr Kiran Majumdar-Shaw of Biocon and Varaprasad Reddy of Shantha Biotech but then the number of entrepreneurs opting for the sector still remains small. Being a science-intensive industry, entrepreneurs find it difficult to grasp the dynamics. Also staring a venture in biotech requires heavy investments and lack of funding mainly at early stages is a major deterrent. Research infrastructure Despite some recent initiatives by the DBT, the lack of infrastructure has been a major bottleneck to promote R&D in India It has been well said that tomorrow belongs to those who can innovate today. This can come only with effective research. As R&D forms the core of the biotech industry, the availability of a better infrastructure plays an important role in its overall success. Positive steps taken by the government in the form of development of bioclusters with great infrastructure at Faridabad, Bangalore and Mohali are commendable. Despite these initiatives, there are certain areas that need to be looked into. The lack of proper research infrastructure has been a major impediment to the growth of life sciences industry. The not so easy access to technology and information along with the better coordination between researchers has been lacking. The need of the hour is a total revamp of the existing structure to promote innovation as well as providing the medium to achieve it including the increase in fund flows. So far, Indian universities have not been able to get proper research infrastructure. The better equipped labs and all the related facilities required for research needs to be provided. There is also a need for co-ordination in different research areas and sharing of facilities between the government and the private sector. Institutional framework The lack of enabling institutional framework led to the compartmentalization of public and private sector activities thus hampering the cause of the research Institutional framework has been recognized as an essential component for the sustainability of the industry. This involves the commitment and genuine involvement of a broad variety of components namely the public sector services; the scientific community; private firms; local and non-governmental organizations. However, in India, gaps in institutional framework and the lack of well-defined roles, have led to cases of conflict of interest between different authorities thus hampering the growth. Therefore, there is a need of having an institutional framework with in-house competent experts from multidisciplinary fields dealing with different aspects simultaneously and finalizing the decisions concurrently. Such an institution could work under a single regulatory authority that could oversee the bio-safety concerns right from the stage of planning and research to product development. This could produce innovative ways of broadening the research-funding base and sharing responsibilities. Better liaison between research providers and research users, and a balance among the research organizations, could force the system to move towards a dynamic and entrepreneurial approach, thus increasing the effectiveness of the overall research system. ]]> <![CDATA[How the Awards came about?]]> https://biospectrumindia.com/news/95/1426/how-the-awards-came-about.html https://biospectrumindia.com/news/95/1426/how-the-awards-came-about.html Mon, 08 Mar 2010 15:18:00 +0530 Four years ago, the Asia edition of BioSpectrum was launched to chronicle the growth of the Life Sciences in the Asia Pacific region. Since its launch in March 2006 in Singapore, the magazine has attempted to bring an Asian flavor to the world of Life Sciences, dominated for over a century by globe-dominating life science companies, formed in the US and Europe. The magazine has succeeded to a large extent in this endeavor. Of course, BioSpectrum is not just a magazine. It is an integrated media platform with the content, gathered from all over Asia Pacific and important global information, delivered in print, digital and online formats, to reach out to the thousands of eager business leaders in more than 12 countries in Asia Pacific and a large community of business leaders in Europe and the US. Four years is a very short time to understand a complex industry like life sciences, which has hundreds of companies providing critical, life saving medical products and services to the humanity. However, in this very short time, the interactions with the industry leaders in the region provided many useful insights into how they all view the role of the industry and their organization's role in shaping the growth of the sector. BioSpectrum has featured many of these remarkable companies and their leaders and highlighted their work and their ambitions. BioSpectrum, first founded in India, in March 2003, has been at the forefront of providing a window to the world into India's fast growing life sciences sector. And the India edition had introduced the BioSpectrum Awards in 2003 to recognize outstanding contributions by entrepreneurs, policy makers and other key members of the ecosystem in promoting the growth of the industry in one of the world's fastest growing economies. With such a successful initiative within the Life Sciences Group of CyberMedia, the publishers of Bio-Spectrum, it was only a matter of time before the concept was extended to the Asia Pacific region. So, the BioSpectrum Asia Pacific Awards was instituted in 2009 and is now in its second edition. The Awards have well-defined criteria and no nominations are invited. BioSpectrum's editorial team brought together a six-member international jury, which rigorously evaluated the shortlist of nominees, put together by the magazine's research team. The jury members were industry leaders who provided critical insights into the industry. BioSpectrum Asia Pacific Awards 2010 jury comprised: Mr G Steven Burrill, CEO of Burrill and Company, Dr Deborah Rathjen, the Chair of AusBio, Australia's leading industry body for biotechnology, Dr Chungcheng Liu, General Director of Taiwan's Biomedical Engineering Lab and Vice President of the country's Industrial Technology Research Institute, Mr Jung Jin Seo, BioSpectrum Entrepreneur of the Year 2009 and also the CEO & Chairman of Korea's Celltrion, Prof Dr B Suresh, President of Indian Pharmaceutical Association, and BioSpectrum Group Editor, E Abraham Mathew. The jury had the excellent insights provided by Mr Steven Burrill, CEO of US-headquartered Burrill & Company, which assiduously tracks the global biotechnology industry and is known for its â€œon-the-markâ€? industry forecasts. Mr E Abraham Mathew, Group Editor of BioSpectrum who had played a key role in formulating the BioSpectrum success story and also the other CyberMedia magazine awards for the last 20 years, was the sixth member of the jury. Over several rounds of emails, the jury members chose the winners in the three categories. The Awards ceremony will be held in Singapore on March 12, 2010. Editor's Choice awards, not selected by the jury, but by the magazine's editorial team, will turn the spotlight onto companies we believe will become the winners in the near future. BioSpectrum Asia Pacific Awards 2010 - Jury Awards BioSpectrum Life Time Achievement Award Dr Kallam Anji Reddy, Chairman, Dr Reddy's Labs, India BioSpectrum Entrepreneur of the Year Dr Xiaochuan Wang, CEO, Sundia MediTech, China BioSpectrum Person of the Year Dr Brian A McNamee, CEO & MD, CSL Limited, Australia BioSpectrum Product of the Year (Joint-Winners) Shanchol, (oral vaccine to protect against cholera) from Shantha OvPlex Ovarian Cancer Test from HealthLinx, Australia Emerging Companies of the Year-Editor's Choice Award Curiox Biosystems, Singapore Moleac, Singapore RNL Bio, Korea Crystal Genomics, Korea Inno Biologics, Malaysia Vita Genomics, Taiwan ]]> <![CDATA[New generation Cholera vaccine]]> https://biospectrumindia.com/news/95/2530/new-generation-cholera-vaccine.html https://biospectrumindia.com/news/95/2530/new-generation-cholera-vaccine.html Mon, 08 Mar 2010 15:12:00 +0530 Efforts to accelerate global use of new generation cholera vaccines gained significant momentum with the licensure of a new oral cholera vaccine, Shanchol, from Shantha Biotechnics in India in 2009. Approximately 200,000 cases of cholera cases per year are notified to the World Health Organization (WHO) in 2007 from 52 countries. This represents an increase of 46 percent in the mean number of cases reported during 2002â€“05 period. In India alone, the overall incidence of cholera is estimated as 1.9 cases per 1,000 but can be as high as nine per 1,000 among children. There are many outbreaks but cholera as a disease is largely unreported. India used to administer an injectable vaccine in the 1970s when cholera was a notifiable disease. However, in 1973, its use was scrapped, as it was only 30 percent effective and provided immunity only for eight months. The only WHO-pre-qualified oral cholera vaccine to date is the double dose Swedish vaccine called Dukoral, which is priced at $60 and needs to be co-administered with a relatively high volume of buffer solution. After 38 years, Indian population gets an affordable and efficacious cholera vaccine in the form of Shanchol. The bivalent oral vaccine is produced by the Indian vaccine giant, Shantha Biotechnics, which is now part of the Sanofi-Aventis group after its vaccines division Sanofi Pasteur, the world's largest vaccine-maker, bought Shantha from Merieux for $550 million, valuing the company at a stunning Rs 3,740 crore (about $809 million), more than 16 times its turnover. Shanchol consists of killed whole cells from a mix of pathogenic strains of Vibrio cholerae (O1and O139) and is given in two doses, each dose in six weeks gap. The vaccine currently priced at $1.85 is licensed for use in adults and children above one year old. The product is very innovative as it incorporates all the important genes required to make it very selective and more effective without harming the intestines in any way. It is designed to prevent even severe infections caused by various mutants of the cholera virus. The vaccine was approved in India last year based on the results of phase II trial on 70,000 human subjects (aged one year and over) conducted in Kolkata by the National Institute of Cholera and Enteric Diseases (NICED). The Kolkata trials found the oral cholera vaccine to provide over 67 percent protection and no decline in protection over two years. Shantha Biotech has spent $1.5 million to set up facilities for Shanchol production. A collaborative effort The bivalent inactivated-whole-cell oral cholera vaccine has been developed in collaboration with the International Vaccine Institute (IVI), Seoul, South Korea. IVI scientists developed this vaccine, with funding from the Bill & Melinda Gates Foundation, by significantly modifying a vaccine used and produced only in Vietnam by VA Biotech, so that it meets international GMP standards and WHO production guidelines. Following field trials in India and Vietnam showing the new vaccine to be safe and immunogenic in both adults and children, IVI scientists transferred the technology for the vaccine to Shantha Biotechics. â€œShanchol is the first new vaccine to be developed and licensed with funding from the Gates Foundation, also the first licensed vaccine developed by the IVIâ€? says Varaprasad Reddy, Managing Director, Shantha Biotechnics, Hyderabad, India. The IVI aims to make this vaccine available for use in public health programs in India and other cholera-affected countries in Asia and Africa to control endemic cholera, also to help control large scale outbreaks. Going forward Shantha has applied to WHO for pre-qualification of Shanchol, to allow its purchase by United Nations agencies, including UNICEF, and to facilitate its use in other countries. The company is currently producing 1.5 million doses of the vaccine but Reddy has plans to scale it up to 10 million doses in the next few years. Among other developments, the company is progressing with its plans to start the first human clinical trial of rotavirus vaccine. It is also about to start the phase I trial for the typhoid polysaccharide in the next few months. The company is also in the process of developing a hexavalent vaccine. As the first Indian company to launch an r-DNA hepatitis B vaccine, Shanvac B, in 1997, Shantha heralded a new beginning for biotechnology and affordable healthcare in India. The Indian company continues to push boundaries and transcend limitations, bolstered by its research-driven scientific ethos. Shantha spends 24 percent of its revenue for R&D each year. Jahanara Parveen ]]> <![CDATA[Multimarker blood test for ovarian cancer]]> https://biospectrumindia.com/news/95/2334/multimarker-blood-test-for-ovarian-cancer.html https://biospectrumindia.com/news/95/2334/multimarker-blood-test-for-ovarian-cancer.html Mon, 08 Mar 2010 15:02:00 +0530 Worldwide 230,000 new cases of ovarian cancer are diagnosed annually with more than 142,000 disease fatalities. Ovarian cancer at its early stages (I/II) is difficult to diagnose until it spreads and advances to later stages (III/IV). This is because most symptoms are non-specific and thus of little use in diagnosis. There is no reliable diagnostic blood test for ovarian cancer. The current market gold standard, CA125, is used as an aid in the diagnosis of ovarian cancer, monitoring treatment efficacy and the detection of disease recurrence. CA125, however, does not display adequate sensitivity or specificity as a primary diagnostic for ovarian cancer at any stage of disease progression. Hence, most women are diagnosed with ovarian cancer when it is too late to be treated, reducing the probable survival rates. Considering this unmet medical need, a team of scientists at HealthLinx, an emerging biomarker and diagnostic company with an integrated platform in biomarker and bioactive peptide discovery platforms from Australia developed and launched diagnostic test called OvPlex, which is a superior performing alternative to CA125 for the diagnostic process to identify ovarian cancer in symptomatic women. â€œThe reason ovarian cancer is the most lethal of the reproductive tract cancers is that 75 percent of women with ovarian cancer are not diagnosed until late stage disease. Their chances of surviving five years are probably only 20-30 percent. If the disease is diagnosed at an early stage, when it is contained within the ovaries, the chance of surviving five years rises to 80 percent. That is why it is so important to try and develop better tests for diagnosing ovarian cancer, particularly early stage disease. That is where we can make a difference and save lives,â€? observes Prof. Greg Rice, Chairman of HealthLinx, Australia. A ray of hope OvPlex is a diagnostic test that measures the levels of five proteins in a patient's blood. One of the proteins is CA125, which has been used for several years for the detection and monitoring of ovarian cancer. When measured along with the four additional proteins that make up OvPlex, a significant enhancement in diagnostic performance can be achieved. OvPlex uses the minimally invasive methodology of a simple blood test. Performance of the OvPlex multimarker test is based on retrospective biomarker trial of 362 samples consisting of 150 patients with confirmed ovarian cancer and 212 patients were free of disease. Based on the analysis of receiver operator characteristic (ROC) curves, OvPlex significantly out performs the CA125 blood test, for both early and late stage disease. For the detection of ovarian cancer, OvPlex delivers 94 percent specificity, 94 percent sensitivity and an overall diagnostic efficiency of 94 percent when used at a threshold of 0.45. OvPlex reduces the overall false negative rate by up to 19 percent and the false positive rate by 42 percent when compared with using CA125 alone. For the detection of early stage (stages I and II) disease, the OvPlex multimarker test also outperformed the use of CA125 alone, delivering 92 percent sensitivity and 94 percent specificity in the biomarker trial. The enhanced performance of OvPlex, particularly with respect to detection of early stage ovarian cancers suggests that it will provide significant benefits in terms of diagnostic performance over the use of CA125 alone. Commenting on developing such a unique product, Nick Gatsios, MD of HealthLinx, says, â€œWe have invested approximately 70 percent of our funding over the past few years, for evaluating the novel biomarkers AGR2 and HTX010. I am proud of our research team as OvPlex was the result of work done by HealthLinx staff. During the development of the OvPlex panel HealthLinx entered into collaboration to access clinical samples with a number of medical institutions in Australia.â€? The development path has also led to the implementation of the current multi-marker composition that was shown to provide the best combination for outperforming CA125 for the detection of all ovarian cancers as well as early stage ovarian cancer in the recent phase II biomarker trial. The research and development team continues to characterize and test other potentially useful biomarkers with the aim of further refining the sensitivity and specificity of the OvPlex product. Narayan Kulkarni ]]> <![CDATA[â€œTraining and application support remain our top priorityâ€?]]> https://biospectrumindia.com/news/95/2132/training-and-application-support-remain-our-top-priority.html https://biospectrumindia.com/news/95/2132/training-and-application-support-remain-our-top-priority.html Mon, 08 Mar 2010 13:50:00 +0530 -Paul Walker, managing director, Malvern Instruments, UK In addition to supplying the analytical instruments, the UK-based Malvern Instruments in partnership with New Delhi-based Aimil has been providing training and application support to the Indian biopharma industry. Recently, Malvern opened a laboratory in New Delhi for providing the application support to the clients based in north India. In an interview with BioSpectrum, Paul Walker, managing director, Malvern Instruments, shares his views on different aspects related to the company, and biosuppliers and biotech sectors in India. Q Can you elaborate on Malvern Instruments and its major partners worldwide? Malvern Instruments provides analytical systems that are used to characterize a wide variety of materials, from industrial bulk powders to the latest nanomaterials and delicate macromolecules. Our systems deliver industrially-relevant data that enables our customers to find the link between micro and macro material properties, and chemical composition. Particle size, particle shape, zeta potential, molecular weight, chemical composition and rheological properties measurements were recently added to the advanced chromatography solutions (GPC/SEC). This has extended Malvern's technologies for protein molecular weight, size and aggregation measurements, and synthetic polymer molecular weight and distribution determinations. Malvern Instruments has its global headquarters in Malvern, UK, with a global distributor network, and applications laboratories around the world. Its subsidiary organizations are located in Europe, North America, China, Korea, Japan and India. Our ultimate aim is to deliver the high-quality experience to customers from all across the world. A major investment of the company in the recent years has been Malvern Instruments' website, which is a resource-rich in information and educational materials, accessible to customers and non-customers alike, wherever they are in the world. Q What are the different segments that the company caters to and who are the major clients? Our products are widely used in academia and in almost every manufacturing sectors. The pharmaceutical industry has always been, and continues to be, a crucially important market for Malvern across our entire product range. The specifications and performance of many of our systems are tailored to meet the requirements of this highly regulated and demanding industrial sectors, and customers in other markets certainly reap the benefits of this approach. Analytical instruments from Malvern can be found in every pharmaceutical company in the world. They are also used extensively in the related biotechnology sector, an area of continuing growth and development for us. Beyond the life sciences, Malvern products are used in the bulk and specialty chemicals industries, cement production, plastics and polymers. We support organizations at every level, from small research groups to multinational corporations that roll out Malvern products throughout their manufacturing facilities worldwide. In India, we work with many leading research institutes as well as manufacturing companies. Q How has Malvern Instruments addressed the needs of Indian life sciences industry since its collaboration with Aimil? The collaboration between Malvern Instruments and Aimil has allowed us to focus on providing a high level of specialist support specifically tailored to the needs of the Indian market and to address the challenges faced by Malvern users in the country. We have been able to provide specialized training and applications support that helps our customers get the most from their Malvern systems and enables them to develop the methodologies they need to do their jobs. Most recently, we started providing direct support for Viscotek GPC/SEC systems in India. This followed Malvern's acquisition of Viscotek in 2008. The response to our joint venture, Malvern Aimil Instruments, has been extremely positive. The demand for training courses continues to be high. Many companies appreciate the regular, structured and customized packages â€“ a ready-made solution that they can confidently incorporate as part of an employee's initial or ongoing training schedule â€“ we provide. Q What is the idea behind the launch of this new center for excellence lab in New Delhi? The success of Malvern Aimil Instruments and the growing number of Malvern customers in India is fuelling the demand for increased training and applications support, and the need to expand the facilities we have for delivering this. The new centre of excellence in New Delhi will ensure that we provide support as locally as possible for our customers in north India, and that too effectively in a timely way. There will be a full-time applications team and the lab will be equipped with a complete range of Malvern systems for use in demonstrations, for sample analysis and for training. Q What are the new areas Malvern looks forward to? We will continue to extend our technology leadership and will improvise in delivering the best possible support in all the markets we serve. The further development in new or emerging markets around the world will require significant attention and effort, as well as the application of that same high degree of customer focus that has enabled us to succeed even through the recent difficult economic times worldwide. Q What have been the company's revenue growth in the previous fiscal and what is the expected revenue growth for the coming years? Malvern's financial performance is reported within the accounts of our parent organization, Spectris. I am not at liberty to provide separate detailed information. What I can say, however, is that the year 2009 was the best year ever for Malvern in terms of sales, an achievement that everyone in the company could be proud of, especially when considering the challenges in the global economy. Q What according to you are the challenges before biosuppliers as far as the product supply in India is concerned? All manufacturing at Malvern Instruments takes place in the UK in an established facility using the most modern techniques and protocols. We have a well-established supply chain, long experience of shipping instruments and accessories to even the most remote places, and then of providing the necessary support to our customers for commissioning, training and service. In a country as large as India, the geography will always be a challenge, but that is the reason for our investment in so many offices and application centers. Q How is the biotech industry in India shaping up and what are its future prospects? Biotechnology is a relatively young sector in India and as such is growing rapidly and creating demand for many different measurement technologies. In protein characterization there is a huge demand, and it is a field in which Malvern offers a range of solutions with a variety of systems that can be configured to meet the analysis requirements of individual laboratories. These include the Zetasizer family, which uses dynamic and static light scattering to measure the size and molecular weight; and the full-range of Viscotek advanced gel permeation/ size exclusion chromatography (GPC/SEC) systems and detectors. Q Are there any plans for expanding the product offerings of Malvern? There are exciting developments in several areas of science and industry in which Malvern systems are used. As manufacturing industry strives to ensure future growth, Malvern products contribute to product innovations, improvements and efficiencies. New technological developments and the way we apply them make Malvern support customers' need. Rahul Koul in New Delhi ]]> <![CDATA[BIO Services]]> https://biospectrumindia.com/news/95/2108/bio-services.html https://biospectrumindia.com/news/95/2108/bio-services.html Mon, 08 Mar 2010 13:43:00 +0530 SIRO forms alliance with Korean CRO SIRO Clinpharm, a contract research organization (CRO) with presence in India, Europe, and the US has formed an alliance with DreamCIS, a leading CRO based in Seoul, South Korea. DreamCIS offers clinical research services to pharmaceutical companies, bio venture companies, medical device manufacturers, and functional food producers. â€œWe are one of the leading CROs in South Korea. However, considering increasing number of global clinical trials and the rapid growth in Asian clinical trials market, we were looking at associating with a CRO having a global exposure; not only from business perspective but also from the perspective of moving up on the learning curve. I think our mutually beneficial alliance with SIRO is a definite step in this direction,â€? said Won-Jung Choi, president, DreamCIS. â€œKorea is a rapidly growing clinical trials market due to pre-approved and well-equipped clinical trial sites, trained professionals, and transparent and efficient regulatory processes. We are confident that this alliance will be of immense value addition to SIRO and widen our global service capabilities,â€? said Dr Chetan Tamhankar, CEO, SIRO Clinpharm. Endo, Jubilant expand oncology partnership Jubilant Biosys and Endo Pharmaceuticals have expanded their drug discovery partnership in oncology. This one-year-old partnership focuses on Jubilant delivering preclinical candidates in the therapeutic area of oncology. Endo owns the late-stage development and commercialization rights for molecules discovered as part of the partnership. Jubilant derives research funding and success-based development and commercialization milestones. Commenting on this development, Sri Mosur, CEO and president, Global Drug Discovery and Development, Jubilant Biosys, said, â€œWe are pleased that we could deliver early success to the discovery portfolio efforts at Endo Pharmaceuticals and this expansion is a testimony to Jubilant's focus on building world-class oncology capabilities, among other therapeutic areas. This collaboration further reinforces the concept of globally leveraged R&D that creates a platform for scientists from Endo and Jubilant to collaborate in finding affordable remedies for cancer patients worldwide.â€? Omnicare licenses LiquentConnect SaaS solution Omnicare Clinical Research has licensed LiquentConnect, a hosted software as a service (SaaS) solution used to create, review, amend and submit regulatory dossiers. Omnicare Clinical Research is a phase I to IV global contract research organization serving the biopharmaceutical and medical device industries. LiquentConnect enables organizations to produce their own eCTD and non-electronic submissions without investing in IT infrastructure. All software and hardware upgrades are managed and executed by Liquent, a regulatory and clinical services provider for the life sciences industry. LiquentConnect is fully-executable for eCTD, NeeS and CTD publishing. Omnicare Clinical Research selected Liquent and will be utilizing LiquentConnect as its hosted solution provider due to its depth of expertise within the regulatory and life sciences industry. The benefits of implementing a fully-managed SaaS solution outweighed the time and resource investment required for other solutions. ClinTec's sales revenue up by 45% ClinTec International, a full-service CRO, has achieved organic growth with a 45 percent increase in global sales revenues over the last 12 months. The company has also expanded its client base and signed new contracts with 11 of the world's top 25 pharmaceutical firms. ClinTec has played a key role in 2009 in facilitating complex restructuring programs for global pharma, who are searching for innovative ways to optimize their R&D efforts. Kemwell builds new facility in Bangalore Bangalore-based CRAMS player, Kemwell has started the construction works of its new non-sterile liquid facility in Bangalore. The new facility will be ready for operation in May 2011, and it will double Kemwell's current capacity to produce 250 million bottles per year, with provisions to increase the capacity to another 60 million bottles annually. The facility will be highly automated and flexible to serve both large and small scale requirements of Kemwell's current and new customers. It will also be designed to meet the quality requirements of regulated markets. Clinigene deploys SAS software solution Clinigene, a Biocon group company and a full-service CRO has deployed SAS Clinical Data Management -PheedIt solution to accelerate its clinical research. Manoj Yasodharan, manager - clinical data management and biostatistics, Clinigene International, said, â€œSAS PheedIt provides a complete solution for clinical data management and analysis. We have successfully reduced the time to setup new trial projects. SAS partnership gives control over the entire data management, analysis and reporting process.â€? ]]> <![CDATA[â€œWe intend to make India our base for clinical development, manufacturingâ€?]]> https://biospectrumindia.com/news/95/5656/we-intend-to-make-india-our-base-for-clinical-development-manufacturing.html https://biospectrumindia.com/news/95/5656/we-intend-to-make-india-our-base-for-clinical-development-manufacturing.html Mon, 08 Mar 2010 13:04:00 +0530 - Sandeep Sahney, managing director, Genzyme India, Gurgaon Genzyme Corporation, one of the leaders in developing advanced technologies for the life sciences industry, has ambitious plans for India. These include launching their entire global portfolio of niche drugs in the next three to four years, rolling out a number of research initiatives, inking collaborative deals and in the future make India their base for clinical development and manufacturing. In a free-wheeling interview to BioSpectrum, Sandeep Sahney, managing director of Genzyme India, shares various initiatives and strategic plans of Genzyme for India. Q What have been some of the achievements of Genzyme India since its inception in 2007? Within 25 months of our existence in India, we have been able to bring five novel treatments to the market. All of these meet specific demands of clinicians in the areas of transplant medicine, osteoarthritis, renal disease and hematology/ oncology. Besides this, we have created an access mechanism on a compassionate basis, for our enzyme replacement therapies (ERTs) that are the only approved and available treatments for some of the genetic disorders. Because of our investment in the area of clinical development, we have several ongoing programs in India. While some of these are global trials, we are also supporting many studies to create indigenous data on various diseases and their progression-for the very first time in many cases. In November 2008, Genzyme entered into research collaboration with the International Center for Genetic Engineering and Biotechnology (ICGEB) for the development of new, improved treatments for malaria under our Humanitarian Assistance for Neglected Diseases (HAND) program. This collaboration includes an innovative approach to intellectual property rights, providing ICGEB the rights to commercially use the neglected disease portfolio on a royalty-free basis. We have also instituted two Genzyme India Fellowships for Excellence in Biotechnology at the National Institute of Pharmaceutical Education and Research (NIPER) that comes under the aegis of the Department of Pharmaceuticals, Government of India. Q In terms of investments, is Genzyme looking at India as one of its prime growth destinations? India will be one of the major markets in the coming years and we are taking initiatives to establish our presence in the country. In two of our most recent global launches, India has been among the first five countries on our priority. In addition, we see India as a key player in our global development of newer therapeutic agents and cutting-edge therapiesâ€“be these in the areas of basic research or clinical development or even manufacturing at a later stage. Few months back, we have also begun work on a $100 million (Rs 464 crore) facility in China after about five years of establishing our entity. Q What is the strategy behind free distribution of couple of your products and how supportive is the Indian government towards this initiative? We are currently providing free access of ERTs to numerous children affected by Lysosomal Storage Disorders (LSDs) that include Gaucher, Pompe, MPS 1 and Fabry's disease. A specially created program-India Compassionate Access Program (INCAP)-reflects our commitment to create awareness, helping diagnosis and facilitating proper management of these patients. The mission of INCAP is to provide these therapies and offer the chance of well-being to these patients as a bridge until sustainable funding mechanisms emerge in the country. The program has the oversight of some of the best known medical geneticists from India as well as across the world. Of course, we look forward to both center and state governments support to help more such needy patients. Q How well has this strategy worked in other geographies and how supportive have those governments been? In many societies across the world, Genzyme has started its operations by providing free drugs to LSD patients through various charitable access programs to give the patients a chance to lead normal lives. However, the visible impact of these therapies on the affected children has provided motivation for governments across the world to collaborate with Genzyme and workout sustainable funding mechanisms. Other than the US and western Europe, these therapies are funded by the state even in emerging markets like Brazil, Russia, Mexico and South Africa as well as in countries like Chile, Bulgaria and Malaysia. Q How encouraging is the Indian market when it comes to product launches? Our experience has been an extremely positive one and this is due to the product mix that we bring to the global market. We do work in the areas of unmet medical needs and hence our therapies really offer significant benefits to the patients in need. In these areas, we have found a very welcoming attitude from both the Indian doctors as well as patients who look for the best treatment options. Q Which disease areas are you looking at in India? We plan to bring in our entire portfolio of products and services to India in the next three to four years as each of them does offer substantial benefits. And unfortunately, we do have patients in India for practically the entire spectrum of diseases including those afflicting developed as well as underdeveloped societies. Hence, there is a visible need for effective management in all the disease areas that we are working on presently. The major therapeutic areas of interest include transplant medicine, renal, hemato-oncology, orthopedics and genetic disorders. The relatively newer areas of interest and development include multiple sclerosis (MS) and cardiovascular diseases. Q What kind of partnerships Genzyme looks forward to in the future? As a company we are extremely focused on enhancing patient outcomes and that forms the basis for all that we do. Hence, besides the requisite domain experience-research or commercial areas-we look for the two qualities of patient focus and ethics in our prospective partners. We are actively looking at partnering in both research as well as commercial areas and that is one of the mandates that Genzyme India has from the corporation. We are in active exploration stage on both counts. Q There is no independent regulatory structure for biologic drugs in India? Is that an issue for Genzyme? This is certainly an area of concern as we work on some of the most cutting-edge therapies including cell and gene therapies. There is a definite need for right-skilling regulatory professionals besides creating a distinct pathway for the biologics. We do realize that this is a newer area for the regulators and we are open to sharing with them all that we have learnt in our journey of nearly 30 years. Q Has the global meltdown affected Genzyme India's operations? Not really, and in fact it has brought out the salience of building operations in India at a faster pace. Q What are the achievements of Genzyme India as compared to its counterpart in China? India and China are two different markets and the scope for fast growth is their common feature. Genzyme is operating in China for a longer period and hence has its own set of achievements. As far as India is concerned, all I can say is that we are moving as per plan and as a company, we do focus on long-term growth more than some of our counterparts. Q What is your take on the Indian biotech industry? Biotech industry in India is still at a nascent stage, but, it offers tremendous opportunity for the simple reason that the global biotech industry is less than 40-year-old. On the commercial side, the market is becoming more sophisticated and both doctors and patients are looking for more customized and innovative solutions to address medical needs. In the area of research and development, there is a great chance for us to 'catch-up' and lead, probably much more than the conventional pharmaceuticals. At present the indigenous efforts are directed more at the development of biosimilars, we do see the government taking steps to foster and support the path to innovation. From our perspective, we will be happy to participate in some of these plans to develop newer therapies in India and hence assist in capability and capacity building for the country. Nayantara Som in Mumbai ]]> <![CDATA[â€œIndia, china on parâ€?]]> https://biospectrumindia.com/news/95/1983/india-china-on-par.html https://biospectrumindia.com/news/95/1983/india-china-on-par.html Mon, 08 Mar 2010 12:46:00 +0530 Stategies of leading MNC's give equal importance to both countries-Ramesh Srinivasan, Principal, McKinsey & Company, US With the blurring of geographical boundaries and the world shrinking to become a 'global village', life sciences companies are actively looking at tapping the opportunities in the developing countries. In an exclusive interview with BioSpectrum, Ramesh Srinivasan, Principal, McKinsey & Company, US, expresses his views on the opportunities that developing countries have to offer in the coming decade, the debate on India and China, and his optimistic opinion on the Drug Controller General of India. Q Do the emerging markets have the capabilities to prove themselves in the drug discovery space rather than drug development? If you look at R&D investments made by multinational companies (MNCs) in the emerging markets, you will notice that most of them are mainly looking at drug development, supporting clinical research, data management and support services for drug development. But, that trend is changing now, as these regions, especially India, are also looking at basic drug discovery research and innovation. In India, companies are setting up research centers like the Bristol-Myers Squibb (BMS)-Biocon Life Science Center for Excellence in Bangalore for drug discovery. Similarly, many other global companies are partnering with Indian companies for discovery research. Even in China, you will see that people are making investments in basic research as well. Most of the big names have made early inroads and it is going to become a part of their global discovery operations that also depends on the research findings. As they get comfortable in these regions, I can see these operations becoming bigger. Q How aggressively are the top global companies looking at the emerging markets in order to be at par with the regional companies? It is very difficult to point out who will lead the market in these regions, but it would be fair to say that most of the pharmaceutical companies are looking at the emerging markets in a big way and it is one of the top three priorities on their list. If you see the top global companies, they have publicly talked about penetrating these emerging markets whether it is Pfizer, GSK, Novartis or Sanofi-Aventis. For the next 5-10 years, we have to wait and watch how these markets shape up. Q Is the regulatory structure in India a challenge for the growth of biotech industry? Actually, I am quite optimistic as far as the regulatory structure in India is concerned. With the introduction of the product patent in the country, MNCs are getting comfortable here and are open to launch their products here. I also see that the DCGI is very progressive about enabling clinical research, which today has become much easier in India. At the end of the day, you have to protect patent rights that is the responsibility of the government and the DCGI is working towards this direction by making changes to make things easier. Q A number of companies from India and China are looking at biosimilars space in the US and Europe. What will determine the success of this upcoming space? Biosimilars is a sensitive and complex area. Even after the launch of biosimilars in the US, there will be brands, which physicians have to prescribe for their patients. The issue of substitution will not be that intensive here, and above all, we need to see how many competitors we get to see in the biosimilars space as compared to small molecules. So, as of now, the dynamics of the market will depend on how many companies will enter this space and at the same time how stringent are the regulations around the issue of substitution. This can change the relative attractiveness of the market. There might be a possibility of the market becoming less attractive like small molecules. So, it is still an open question as to how this market space will develop. Q Comparing India and China, which country has the chances of being the leader in the life sciences space? In future, companies cannot afford to ignore either India or China. Both these regions have their own set of challenges and advantages. It is a question of how a company looking at entering these markets gets to see a long-term growth in both these countries. Both India and China are at par with each other now. The strategies of most of the leading MNCs across the globe are looking at both the regions and not just one of them. Nayantara Som in Mumbai ]]> <![CDATA[Health Biotech Science Cluster - Faridabad]]> https://biospectrumindia.com/news/95/4769/health-biotech-science-cluster-faridabad.html https://biospectrumindia.com/news/95/4769/health-biotech-science-cluster-faridabad.html Mon, 08 Mar 2010 12:33:00 +0530 The life sciences industry in India has changed for good with the establishment of academic institutes, research centers and expansion of medical and healthcare industry, however, these have remained restricted within their specific boundaries. There have been few examples in India where one could study, research, ideate and productize and monetize those ideas. Now, Bangalore, Faridabad and Mohali are all set to host biotech science clusters where such ideas can come to fruition. Among these clusters, a unique Health Biotech Science Cluster (HBSC) is being developed by the Department of Biotechnology. The HBSC, coming up on a 200 acre stretch, is intended to foster innovative conceptual research in a wide range of biotech-related sciences, with an initial focus on health biotechnology. The cluster will house the UNESCO Regional Center for Biotechnology (URCB) and the Translational Health Science Technology Institute (THSTI) as founding institutes. Initially, these are expected to function from Udyog Vihar, Gurgaon. The first phase of work will start on the 40-acre land at Faridabad and the permanent laboratories are expected to come up over the next three years. A number of other related centers that will have its presence at the cluster are at conceptual stage and the work for these institutes will start in the second phase. These include Center for Vaccinology, Molecular Medicine Center, Center for Diagnostics, Biotech Park, Center for Health Science Technology, Center for Platform Technologies, Incubator, Center for Animal Model for Clinical Advances, and National center for Biodesign. There will also be a common library for institutes that is expected to serve as a platform for discussions and idea generation. The Department of Biotechnology (DBT) cell at the National Institute of Immunology (NII), will oversee the whole project being transformed from concept to finish. On being asked about the difference between the institutes in cluster and the already existing institutes, Dr Shrikumar Suryanarayan, director general of ABLE and CEO, Biotech Cluster, Faridabad, says, â€œUniversities have ideas but they get lost. The need is to share those ideas at the right time with right people. Currently, the academic institutes in India are not designed to support what is required for innovation and there is lack of such multi-disciplinary institutes in India. Therefore, this initiative will serve as a major boost towards such approach.â€? â€œInnovation is a buzz word and there is a difference between innovation and discovery. Innovation should make difference to society and translation is the only key to it. Radio waves are considered as discovery but the innovation came in the form of cell phone. Similarly the establishment of this cluster will promote innovation for human health,â€? observes Dr Shrikumar. The HBSC will include three constituencies -students, industry and patients. With the THSTI and the URCB as founding institutions, there will be domain-specific working groups that will interact in translational research and development programs. The coordinating cluster board will mediate the incorporation of the future institutions such as Clinical Health Center (CHC). The cluster will synergize high-value resources and infrastructure, coordinated development and maximize societal benefits. There will be common policies for all the institutes while keeping their autonomous nature intact. Purpose of HBSC To establish a single entryway to India's translational health science research sector. To foster innovative research within India. To advance India's research collaboration internationally. To secure positive outcomes in healthcare and commercial applications. Dr S Natesh, senior advisor, DBT, New Delhi, while speaking to BioSpectrum stressed upon the fact that this being the high-time to create these kinds of clusters where there will be numerous institutes, discussing ideas and partnering for translating them into substantial products. â€œThe curriculum for the institutes will be the programs relevant to IPR, bioenergy, bio-entrepreneurship, regulatory affairs, health and nanosciences,â€? adds Dr Natesh. Strengthening research Translational Health Science and Technology Institute (THSTI) is an autonomous institution, which will be a part of the interdisciplinary HBSC, being mentored by globally-recognized National Institute of Immunology (NII) and the Harvard-MIT Division of Health Science and Technology (HM-HST). The THSTI will be a dynamic and interactive organization with a mission to conduct innovative translational research and develop research collaborations across various disciplines and professions to accelerate the development of concepts into tangible products to improve human health. The cluster institutions will have access to the state-of-the-art experimental animal facility and the platform technology center for the sophisticated instrumentation. Dr Martha Gray, director of Health Sciences and Technology, MIT-Harvard, US, while talking about the importance of the partnership between the US and India, says, â€œThe partnership will lead to the opening of a chain of collaborations in translational health.â€? Vaccine and Infectious Disease Research Center (VIDRC) is an independent research center of the THSTI with a mission to study infectious diseases and pathogens with the aim to generate translational knowledge for developing prophylactic and therapeutic measures against diseases prevalent in India. The center will be involved in research in relevant areas of immunology, virology, microbiology, structural, chemical and systems biology with interest in furthering the center's mission. Research areas involving the host-pathogen interactions, covering the entire range of expertise and interest from the statistical and epidemiological to the cellular and molecular levels will also be considered. UNESCO's center for biotech Another major highlight of the cluster is a UNESCO-sponsored Regional Center for Biotechnology (URCB). It is an outcome of a joint decision by the Government of India and UNESCO to promote the training and research for generating interdisciplinary human resource relevant to biotechnology. The center is expected to benefit all countries in the region including India in developing knowledge-rich highly-skilled human resource, harmonization of policies and procedures in biotechnology and indirectly promoting trade. The primary focus of URCB will be to provide world-class research, training and education in biotech sciences at the interface of multiple disciplines. It will be a meeting place where innovation, enterprise, and industrial development will germinate. The educational programs of URCB will be designed to create innovative opportunities to engage in research and learn to integrate science, engineering and medicine to provide major breakthroughs of relevance to India. Dr Dinakar Salunkhe, who is currently overseeing the works of URCB, says, â€œThe purpose of URCB will be to focus on human resource, fundamental education and to develop necessary ideas and encourage the growth of industry in the region. It will also function as a platform for integration of the disciplines.â€? The educational programs of the center are designed to create opportunities for students to engage in research where they learn the tools by integrating science, engineering and medicine to provide healthcare solutions and also for developing agriculture and environment technologies. The URCB is expected to provide a platform for interdisciplinary research, education and training in order to create human resources required for the biotech interface of engineering, chemistry, physics and medicine, and to empower human resources critical for a wide range of biotech needs and to seek knowledge-based innovation and context-specific biotechnology solutions. The design and processes of the education at this center will generate technology-savvy solution finders/creators; science entrepreneurs/ knowledge-economy entrepreneurs and R&D leaders. â€œAn important focus of expertise building will be regulation, product development, scale up, manufacturing science and bio-entrepreneurship thus helping in preparation of next generation students,â€? says Dr Salunkhe. Functions of URCB Create and nurture high quality interdisciplinary human resource. Provide globally-oriented education and training. Offer training for physicians intending to enter biology and short-term exposure to biologists and engineers through hospitals and medical schools. Focus on industry-oriented training in: Regulatory affairs Biomedical enterprise/ business development in biotechnology Biomedical quality systems and product development Bioinformatics Biomedical translational research Technology transfer and commercialization Systems biology The uniqueness of this project will be the designing of domain specific programs by the faculty of URCB and THSTI in new opportunity areas of discovery science and technological innovations such as drug discovery and systems biology, cell and tissue engineering, nanoscience and technology, synergy of information technology, and advanced biomaterials, in order to create highly-specialized people who delve across various disciplines. Investigators will be provided shared laboratory space and adequate start-up resources. They are expected to generate eventual extramural project-based funding. The physical proximity of the institutes and the multi-disciplinary approach towards the education are definitely going to have its long-term beneficial implications. Given the enthusiastic response of large number of students, who have blogged to know about the cluster in itself speaks about the importance to transform this unique concept into a reality at a higher speed. With our western counterparts already following this kind of concept, we surely need to increase our pace so that we don't miss this innovation driven bus. Views â€œThe curriculum for the institutes at HBSC will be the programs relevant to IPR, bioenergy, bio-entrepreneurship, regulatory affairs, health and nanosciencesâ€? -Dr S Natesh, senior advisor, Department of Biotechnology, New Delhi â€œAn important focus of expertise building will be regulation, product development, scale up, and developing science and bio-entrepreneurships to prepare next generation studentsâ€? -Dr Dinakar M Salunke, senior scientist, National Institute of Immunology, New Delhi â€œThere is a lack of multi-disciplinary institutes in India. Therefore, this initiative will serve as a major boost towards such approachâ€? -Dr Shrikumar Suryanarayan, director general of ABLE and CEO, Biotech Cluster, Haryana Rahul Koul in New Delhi ]]> <![CDATA[BioSpectrum Technology Forum 2010: Future of India]]> https://biospectrumindia.com/news/95/1582/biospectrum-technology-forum-2010-future-of-india.html https://biospectrumindia.com/news/95/1582/biospectrum-technology-forum-2010-future-of-india.html Mon, 08 Mar 2010 12:18:00 +0530 The BioSpectrum Technology Forum 2010 saw the convergence of R&D heads from the Indian life science industry brainstorming and hashing out strategies for effective R&D in India India has the capability to become a major R&D player in the years to come. Foreseeing this opportunity, BioSpectrum hosted the first ever Biospectrum Technology Forum (BSTF) 2010, which brought together on a common platform, research leaders both from the public and private sectors. The two-day BSTF event included six panel discussions that led to innovative ideas, effective R&D strategies, insights on approaches to accelerate research programs; and information on latest tools, technologies and new collaboration routes. Day one commenced with E Abraham Mathew, chief editor of BioSpectrum delivering the welcome address followed by Dr WM Dhumane, senior joint controller of patents and designs, Government of India, addressing the gatherings on 'The issue of ways and means to improve India's IP environment'. â€œValidating the novelty of a drug is an issue in India. To improve IP environment, India needs to learn from other countries. Perfection is the need of the hour, I am happy to say that India is moving towards that direction,â€? observed Dr Dhumane. Future of R&D The first panel discussion focused on the topic, 'What is needed to promote R&D in Indian life sciences industry and the future forward'. Chaired by Dr PM Murali, CEO, Evolva, the panel members included, Chandrashekhar Nair, founder director of Bigtec; Dr Rustom Mody, CSO and director (Quality), Intas Biopharmaceuticals; Dinesh Puri, CMD, Medived Innovations; Dr Venkata Ramana, research director, Reliance Life Sciences; and Dr Manu Jaggi, director, Dabur Research Foundation. Dr Mody pointed out the obstacles in India's road to innovation, â€œFor innovation, we need patience and funding. Indians, as such, lack the risk appetite, venture capitalists are showing reluctance to invest. Fund managers need to change their mindset. They need to think about the long-term benefits,â€? he said. Dr Mody also stressed that India needs to strengthen its IP environment and could take lessons from the EU which is more systematic and organized. Collaboration strategies Day two commenced with the second panel discussion on 'The collaboration strategy for R&D'. Panelists included Dr PS Ahuja, director, Institute of Himalayan Bioresources and Technology; Dr KC Gupta, director, Indian Institute of Toxicology Research; Narayanan Suresh, group editor, BioSpectrum; Dr Ram Vishwakarma, director, Indian Institute of Integrative Medicine (CSIR); Adiya Burman, MD, OncQuest Laboratories. The key point of this session was the need to spin off companies. CSIR is open to collaboration, spin off small companies and go for PPPs. Researchers in India need to synergize to enter the global scenario. Dr Vishwakarma mentioned, â€œThe key to collaboration includes mutual respect for the other partner. While entering into a partnership, company's scientists should talk to each other rather than the directors.â€? Need for R&D efficiencies The third panel discussion focused on the topic 'Creating R&D efficiencies'. The panel included Dr Swami Subramaniam, director, Worldwide Licensing and External Research-India, Merck; Dr Abhay Deshpande, director, Jai Research Foundation and Dr Mahesh Bhalgat, vice president, Biological E. Dr Subramaniam, said, â€œCollaboration and outsourcing are the emerging models to reduce cost of in-house multiple specialty research facilities and time. Outsourcing is an efficient solution for enhancing efficiency.â€? The Q&A session that followed saw some interesting exchanges very useful to the participants. Genomic research One of the highlights of BSTF was a discussion on the Human Genome Organization (HUGO) project, presided over by Dr Edison Liu, president-HUGO and Dr Partha Majumder, head of genetics, Indian Statistical Institute. Dr Liu mentioned that in genomic research a shift from regions like the US to emerging markets is inevitable in the future. â€œAs far as the HUGO initiative is concerned, the focus now is shifting to Asia, especially to regions like India, China, Singapore and Korea. This region in future will become a very important for genomic research.â€? Overcoming roadblocks The fourth panel discussion was based on the topic, 'R&D during the times of recession'. Panelists included Dr Shailesh Mehta, head of biologics, GSK; Dr Rajeev Soni, president and COO, Premas Biotech; Dr Shivprakash, MD, Synchron Research; Dr Jitendra Kumar, vice president, Life Science Incubator, IKP Knowledge Park; Dr R Ezhil Arasan, MD, Dr VRE Research Laboratories; and Dr Sarjana Dutt, R&D head, OncQuest Laboratories. Panelists agreed that clinical R&D was still a grey area in India. Suggestions provided by panelists covered areas like outsourcing; CROs, CRAMS, and PPPs; strategic licensing; and innovating product for cost-effective R&D. Panelists suggested that research teams should look at the COLA model- to collaborate, to outsource, to leverage expertise mainly licensing and lastly acceptability. R&D leadership strategies BSTF would have been incomplete without the panel discussion with the theme, 'Leadership strategies in R&D â€“ HR perspectives'. The panel consisted some of the prominent HR experts from the life sciences industry: Thomas Putti, VP-HR, Advinus Therapeutics; Mukund Mandyam, director-HR, Quintiles India; Mohan R Sharma, Senior VP-HR, Matrix Laboratories; Niranjan Reddy, VPâ€“HR, GVK BIO and it was moderated by Dr Gopal Dasika, CSO, Actis Biologics. Dr Dasika led the discussion in a logical fashion and all the panelists chipped in with their valuable inputs on the theme. One of the key points discussed was leadership behavior. A common suggestion that came across from Thomas Putti and Niranjan Reddy was, companies should encourage young talent. They should be given full responsibility and credit for their work. They also stressed that young employees should be encouraged to do their PhD. Integrating IP practices Dr Malathi Laskhmi Kumaran, IP expert, Lakshmikumaran & Sridharan, gave an overview on 'Managing IP-Key to R&D strategy'. The last panel discussion was on 'Integrating good IP practices into an organization's DNA'. The panelists included Dr Gopakumar G Nair, CEO, Gopakumar Nair Associates; Dr Milind Antani, head of life sciences, Nishith Desai Associates; Deepam Mishra, CEO, i2indiaVentures; and Dr Rena Patel of RP Consulting, US. The discussion moderated by Dr Antani focused on key aspects like IP management by a company and ways of protect it. In a nutshell, BSTF concluded that when the industry is competing at a global level R&D needs to be the next hot spot. India has to devise a strategy for promoting its R&D agenda. Education system is a good place to begin with. We need scientists and researchers who can think out-of-the-box and can in-turn drive innovation. Moreover, with drug development and commercialization costs sky-rocketing, the industry should look at approaches that drive down R&D costs. They need to re-evaluate their R&D model. The BioSpectrum Technology Forum 2010 thus discussed the strategies to clear some of these roadblocks and drive the country's innovation agenda with efficient R&D. ]]> <![CDATA[Tide Turns Against Biotech]]> https://biospectrumindia.com/news/95/2931/tide-turns-against-biotech.html https://biospectrumindia.com/news/95/2931/tide-turns-against-biotech.html Mon, 08 Mar 2010 11:50:00 +0530 Despite the economic gloom around the world, India managed to emerge unscathed in 2009 with the growth close to seven percent in what has arguably the worst year in our recent memory. The biotechnology industry too managed to weather the storm and stay afloat with very little collateral damage. However, as I write this 7th anniversary issue special edit of BioSpectrum, the mood seems to have turned sullen at least for a section of the industry. The Bt brinjal developed by Mahyco is at the heart of the gathering gloom which has turned enormous public attention on biotechnology as a whole unwittingly. As I had predicted and was widely expected in my previous editorial, Environment Minister Jairam Ramesh has brought the Bt brinjal story to a halt for now. The hurriedly convened press conference on February 9 and the subsequent clarifications told the story. No hurried decision on commercialization of Mahyco's Bt brinjal hybrid for now. The moratorium will be in place till the regulatory system is in a position to evaluate credible, independent data on toxicity aspects of Bt brinjal. At the same time the government has helpfully clarified that there is no moratorium on genetically modified (GM) foods per se but only on this particular product under regulatory process. The fate of Bt brinjal was sealed by two key developments. One, Jairam Ramesh's decision to go on a nationwide consultation process in January and February 2010. The 8-city event gave the right high profile platform needed by anti-GM forces to make themselves heard. The industry and the few scientists willing to stand up for GM foods could not match the support drummed by civil society groups with a combination of rhetoric, emotions and folklore. Two, the strident voices for caution expressed two eminent geneticists, Dr MS Swaminathan and Dr PM Bhargava. These two factors were a potent anti-GM combination which Jairam Ramesh, even if he had wanted, could not have overcome to allow Bt brinjal for now. One is not sure how Mahyco's Bt brinjal will play out in the coming months or years. Either it could get commercial approval quietly or delayed for a few years till independent studies are ready. If latter is the case, then the wait could be easily for a few years. A quiet commercial release appears unlikely given the range of civil society forces ranged against the product in particular and GM foods overall. And the anti-GM forces would be keeping a hawk's eye on all related developments about this product. However, there is a silver lining amidst the dark clouds gathering over the biotech sector, particularly due to the agri-biotech segment. The long pending legislation to set up a unified regulator in the form of the National Biotechnology Regulatory Authority (NBRA) has got a fillip. The Prime Minister's support to speed up its passage will help to overcome the hurdles within the government which had stymied its progress since 2005. The bill was stuck apparently due to the tussle between the ministers (ministries) of S&T and Agriculture in the UPA-1 government. DBT secretary Dr MK Bhan is hopeful of tying up the loose ends and sending it for Cabinet approval in March. Then the bill will be placed before Parliament for debate and approval. Even here, some sections of the current draft bill related to steps to tone down anti-GM opposing voices have run into a public controversy. Here again the main opposition to the NBRA bill coming in due to the clauses related to GM products. It is again now anybody's guess how the NBRA's passage through Parliament amidst these tumultuous developments in the backdrop of Bt brinjal controversy will happen. Group Editor sureshn@cybermedia.co.in ]]> <![CDATA[The arrival of next generation sequencing]]> https://biospectrumindia.com/news/95/2477/the-arrival-of-next-generation-sequencing.html https://biospectrumindia.com/news/95/2477/the-arrival-of-next-generation-sequencing.html Fri, 05 Feb 2010 12:51:00 +0530 Indian scientific research in recent times has witnessed two major breakthroughs. A common bridge between these breakthroughs is the next-generation sequencing technology from the US-based company—Illumina The Zebrafish genome which is about half the size of the human genome, containing about 170 crore DNA base pairs, is the first eukaryotic genome that was sequenced by the Council for Scientific and Industrial Research (CSIR) scientists in India. The research team at Institute of Genomics and Integrative Biology (IGIB) generated over 89 gigabases of DNA sequences in two months time resulting in over 20x coverage of the Zebrafish wildtype strain genome. This humongous exercise was made possible with the CSIR supercomputing facility at IGIB. Another breakthrough happened when the first human genome sequencing was completed in India by CSIR scientists. During this exercise 51 gigabase data was generated leading to 13x coverage of human genome. Indian scientists have also successfully carried out small RNA chip sequencing, methylation sequencing, transcriptome sequencing and digital gene expression studies for human and non-human species. Now what forms a common bridge between all these events is the technology used to sequence all these genomes. The next-generation sequencing technology from the US-based Illumina has enabled massively parallel sequencing of millions of genomic fragments ranging from 36 to 76 base pairs, which are then mapped back to the reference genome. Illumina’s Genome Analyzer has been adopted across genome centers worldwide, as well as individual research labs, core and service facilities, and biotechnology and pharmaceutical companies. The Genome Analyzer offers the highest rate of daily output and the simplest, most user-friendly workflow. It supports the broadest set of applications, including those used to profile and discover novel transcripts, to create high-resolution genome-wide maps of DNA-protein binding sites and to sequence entire human genomes to greater than 30x coverage. In India, Illumina launched its operation in 2005 and got its first platform that is Bead Array installed at IGIB in 2007. Currently, Illumina is represented exclusively in India by Premas Biotech based out of Manesar, Gurgaon, and has more then 11 installations of its flagship genetic analysis platforms. Microarray-based Iscan Platforms are installed at seven centers including a service provider named Sandor Proteomics in Hyderabad. Four Genome Analyser platforms and a Bead Express array platform were also installed. Sandor and IGIB have both carried out pioneering GWAS studies using Illumina and more then 9,000 samples have been processed till date. IGIB scientists are currently using it for genotyping and expression analysis. Indian scientist have used Illumina for human, plants and animal genetics studies. “This technology has been readily acceptable to people and it is the second generation genome analyzer in true sense,” says Rajeev Sindhi, managing director, Sandor Proteomics, Hyderabad. “The genome analyzer in a single run, spanning nine days, can generate upto 50 gigabytes of data,” says Praveen Gupta, vice president — business development, Premas Biotech, Haryana. Currently, a couple of de-novo sequencing projects are using Genome Analyser in India. Illumina has made immense contribution for research in India by reducing the SNP genotyping and gene expression costs and increasing the throughput majorly by multiplexing. Illumina offers both custom genotyping as well as whole genome genotyping solutions. — Rahul Koul in New Delhi ]]> <![CDATA[Mobile intelligence for life science companies]]> https://biospectrumindia.com/news/95/7220/mobile-intelligence-for-life-science-companies.html https://biospectrumindia.com/news/95/7220/mobile-intelligence-for-life-science-companies.html Fri, 05 Feb 2010 12:49:00 +0530 Cegedim Dendrite expands CRM operations in India Mobile intelligence enables companies to capture data easily and build institutional knowledge. The solution provides sales forces with a robust set of customer relationship management capabilities that promotes team selling, multi-channel customer management, information sharing, field reporting, and analytics — all within a life science-tailored mobile application that is easy to use.   Adil Vazifdar, account director of Cegedim Dendrite in India, says, “India is one of the seven most important emerging markets in life sciences. The domestic market is estimated to grow at a Compound Annual Growth Rate (CAGR) of 10 percent per annum over the next 5-6 years and is expected to touch $13-15 billion (Rs 60,256-69,525 crore) by 2015. When considering the kind of complexity that presently prevails in the market place with more than 600,000 doctors and an equal number of chemists it is no wonder that most life sciences companies in India are looking at the best of breed customer relationship management (CRM) solution.” “Mobile intelligence is a modular system that allows companies the flexibility to choose the most appropriate functionality for the various roles in the organization and the diverse teams. It offers modules that meet specific and evolving needs of the life sciences customers around campaign management, key account management, institutional sales (hospital) management and key opinion leader management. Similar flexibility is provided from a technology perspective since the system is available either as a SaaS (software as a service) offering or as an on-premise solution offering. It is available on various devices – desktops, laptops, netbooks and other mobile devices like the PDA, Blackberry and the iPhone,” adds Vazifdar. Cegedim’s India strategy is to cater to companies spanning across the entire life sciences spectrum. “We are seeing different needs depending on where a company is in the sales force effectiveness maturity cycle. On the one hand, there are multi-national companies for whom CRM initiatives are driven at a global and regional level and there is a greater focus on optimizing resources, especially if they are in the growth phase; on the other hand, some of the companies have been through the first phase of call tracking and are now looking at new areas like superior targeting and segmentation, improved effectiveness of campaigns, and new team structures to address the changing landscape. Our strategy is to focus on these key areas of needs,” says Vazifdar.   Having a market share of 35 percent in the life sciences space, Cegedim Dendrite had invested in an offshore development center in Bangalore more than five years ago. With close to 400 employees, the Global Solution Center currently provides services ranging from product development to end-user support. Cegedim Dendrite’s activities are already activated in South America and Africa. So far, APAC is the largest market for the company. Cegedim has already established its presence in markets like Japan, Korea, Australia, China and South-East Asia. In the APAC region, India and China are the clear focus; and Korea, Thailand and Vietnam will also be given importance in the future. — Nayantara Som in Mumbai ]]> <![CDATA[BIO 2010 Ready for roll out]]> https://biospectrumindia.com/news/95/2899/bio-2010-ready-for-roll-out.html https://biospectrumindia.com/news/95/2899/bio-2010-ready-for-roll-out.html Fri, 05 Feb 2010 12:42:00 +0530 A global event for biotech biz The 2010 BIO International Convention is a global event addressing the business of biotech. This year the event is scheduled to be held on May 3–6, 2010, at McCormick Place in Chicago, Illinois, US. The theme of this year’s convention is to fulfill the promise to heal, fuel and feed the world by developing the life sciences in vital areas. The convention will not only give insights on the next great medical breakthrough, but also reflects what companies are doing to develop cleaner fuels and to advance agricultural biotechnology. The 2010 BIO International Convention delivers partnering, networking and learning opportunities—from the BIO Business Forum to the BIO Exhibition to Keynote Luncheons and more than 125 Breakout Sessions in 17 tracks. Partnering Opportunities The BIO Business Forum of the convention delivers access to over 4,000 top business development and licensing professionals, representing 1,800 companies from over 35 countries. BIO Business Forum attendees have the opportunity to schedule up to 80 30-minute face-to-face meetings during the three-day convention. Attendees will gain insights into more than 100 emerging companies in a number of important categories such as cancer; drug discovery; gene/cell therapy; infectious diseases; pharmaceuticals; food and agriculture; industrial and environmental sciences. The BIO Business Forum is the strategic gathering place for biotechnology and pharmaceutical companies, academic research institutions and investors from around the world to learn about each other. Education Program The 2010 BIO International Convention education program features more than 125 Breakout Sessions across 17 tracks, including business development, healthcare, industrial, environmental, and food and agriculture. Keynote Luncheons Keynote Luncheons will give the delegates an opportunity to hear what is on the minds of experienced and influential global thought-leaders. The keynote features former Presidents Bill Clinton and George W Bush. BIO President and CEO, Jim Greenwood, will moderate the discussion. Al Gore, former US Vice President, and world renowned climate change thought-leader, will also deliver keynote. He will share his vision and passion for making the world a better place to live. The BIO International Convention features formal and informal networking, and special events that offer business development and social opportunities. BIO Exhibition Designed to connect participants with the industry’s top innovators, the BIO Exhibition provides the platform to learn about exciting opportunities that will help heal, fuel and feed the world. The exhibition will have over 60 domestic and international pavilions; more than 1,900 exhibitors; six product focus zones; interactive theaters; emerging technologies, valuable industry connections and more. New product focus zones in BIO 2010 include contract services zone, discovery zone and BIOPark (a mimic of a true biotech park). To learn more about 2010 BIO International Convention, visit: www.convention.bio.org ]]> <![CDATA[â€œAPAC accounts for 18% revenueâ€?]]> https://biospectrumindia.com/news/95/1575/apac-accounts-for-18-revenue.html https://biospectrumindia.com/news/95/1575/apac-accounts-for-18-revenue.html Fri, 05 Feb 2010 12:36:00 +0530 -Dr Joachim Kreuzberg, CEO, Sartorius AG, Germany Within two decades, Germany-based international laboratory and process technology provider, Sartorius, has built up a strong position in India and Asia by gaining a wider customer base that includes biotech, pharmaceutical and food sectors. Sartorius India has recently established a new production and R&D facility in Bangalore, that spreads across 107,640 sq.ft. with an investment of 6.5 million euros (Rs 45 crore). Sartorius sees India and Asia Pacific as high growth areas for its business. BioSpectrum finds out more from Dr Joachim Kreuzberg, CEO, Sartorius AG, Germany about the company's growth in Asia. What percentage of Sartorius Group's revenue is from the Asia Pacific region? We will get the initial revenue figures for the full year of 2009 in February 2010. Our nine-month sales revenue was estimated at 445 million euros (Rs 2,966 crore); the Asia Pacific region accounted for around 18 percent of this figure. How is the growth rate of the company? Asia is an important growth market for both of our group divisions. This will continue to be so in the future as well. In recent years, eight percent growth rate has been registered. For the year 2009, I expect a growth rate of 10 percent. What are the major steps taken by Sartorius in Asia? For many years, Sartorius has been active with its own sales and production companies in Asia. Twenty years ago, we started our activities in India by entering the local market to establish our presence. Sartorius founded a sales and service organization in Hong Kong, China, in 1988. Since 1996, Sartorius has its presence in Beijing with its manufacturing site for laboratory balances and industrial scales. The new plant in India is the second-largest investment of Sartorius in Asia in the recent years. In the meantime, we have been employing over 800 people in the Asia Pacific region, of whom 200 work in China and 400 in India. There is an intensive transfer of know-how between colleagues in Germany and their counterparts in Asia in order to maintain global quality standards in locally manufactured products. Can you elaborate on the growth plans for Sartorius' biotechnology division? Our biotechnology division is undergoing a growth phase as the demand for medications will continue to rise worldwide. Experts predict that the global pharmaceutical market will grow approximately at a rate of five percent, whereas the compound average growth rate of the biopharmaceutical segment is expected to reach 11.5 percent by 2014. Sartorius Stedim Biotech is excellently positioned to be a part of this growth. We have a presence in all key pharmaceutical markets, a wide and innovative product portfolio and a very strong brand; and our customers' awareness of our brand is also high. In addition, the biopharmaceutical industry is in the midst of a technology change from reusable to single-use production equipment, which we as suppliers and partners are strongly propelling forward. In the case of single-use products, we have gained a leading position in the market, which we plan to extend in the next few years. What are the key areas of focus for Sartorius in the coming years? As a growing number of medications are now being manufactured using biotechnology, our biotechnology division has given more importance to meeting the needs of the biopharmaceutical industry. We are concentrating on developing innovative products and efficient technologies for laboratory applications, cell culturing and fermentation, filtration, purification, liquid transfer/handling and an entire range of services. We offer our customers a wide array of products, which is mainly based on single-use components, such as filter capsules or bags. We also provide integrated solutions for the convenience of our customers to match our completely preconfigured, perfectly compatible single-use equipment with their individual process steps. In the mechatronics division, we plan to concentrate even more strongly on the food and pharmaceutical industries. In these segments, we consider process analytics as an attractive business field that has a promising future, and we also have plans in place to substantially extend our activities in this area in the coming years. ]]> <![CDATA[â€œCliniRx eyes tier III towns"]]> https://biospectrumindia.com/news/95/2443/clinirx-eyes-tier-iii-towns.html https://biospectrumindia.com/news/95/2443/clinirx-eyes-tier-iii-towns.html Fri, 05 Feb 2010 12:27:00 +0530 - Dr Rita Karia, CEO & president, CliniRx Research, New Delhi Geared up by the increasing rate of outsourcing by the pharma companies, the clinical research market has been able to survive the recession. Therefore, more and more Indian clinical research companies are going global and expanding their service horizons. India is poised to register enormous growth in this sector. In an exclusive interview with BioSpectrum, Dr Rita Karia, president and CEO of CliniRx, shares the vision of her organization, the need for reforms and the current clinical research market scenario in India. Can you share some insights on CliniRx as a clinical research organization? CliniRx is a full-service clinical research organization (CRO) that provides clinical trial services to pharmaceuticals and biotechnology companies. The company conducts multi-national clinical trials in phase II, III, and IV with full-service capabilities and biometrics delivery capabilities in phase I. It has offices across the US, Europe and India along with a good network of alliance partners across Europe and Russia. How supportive is the government in terms of regulatory approvals? The government bodies like the Drug Controller General of India (DGCI) have been very supportive in their contributing roles. CliniRx has been actively involved in a number of corporate bodies contributing to guidelines and directives for the CRO industry including joint activities with the Federation of Indian Chambers of Commerce and Industry (FICCI) for the formulation of biotech devices directive. The government needs to support the CRO sector in line with the tax benefits given to the IT industry, in order to support the growth of this sector. The support includes tax benefits to R&D facilities, and tax concessions for training to support development of the talent pool to encourage larger number of clinical trials in India. Accreditation of sites and principal investigators, based on globally accepted criteria is another important aspect for which government support would be welcome. How good is India as a destination for clinical trials as compared to other Asian countries? India has a large number of English speaking educated personnel with relevant skill sets. We have over 600,000 English speaking physicians in key therapeutic areas with 30,000 new doctors being added every year. India has a patient mix capable of meeting diverse clinical trial requirements. The patient recruitment rate is very rapid in comparison to recruitment in developed countries. A potential area to leverage for India is the creation of automated and transferable patient records. In China, the cost of the trial may be low but the regulatory process is still very lengthy. There has been more growth in the number of principal investigators involved in clinical trials in India as compared to China. How is the approach of CliniRx different from others in the clinical research market? As an organization, CliniRx has strategically positioned itself as a long-term player right from its inception. It has made substantial investments for procuring the state-of-the-art software. The most important investment is for talented workforce and CliniRx has a highly qualified and skilled team in place. An experienced team of experts contributes their therapeutic expertise to each project. CliniRx has worked in over 200 sites in India from tier I, II and III cities and we are now expanding to involve more tier III towns to help prevent saturation in particular locations. What are the future plans of CliniRx research? CliniRx has a strategic intent to expand its geographic footprint outside India. We are in discussion with companies in the US and Europe to support our plans. We have gained proficiency in CNS, pain, oncology and cardiology and are now actively exploring opportunities in endocrinology and respiratory trials. — Rahul Koul in New Delhi ]]> <![CDATA[Dark clouds gather over Bt brinjal]]> https://biospectrumindia.com/news/95/1860/dark-clouds-gather-over-bt-brinjal.html https://biospectrumindia.com/news/95/1860/dark-clouds-gather-over-bt-brinjal.html Fri, 05 Feb 2010 11:36:00 +0530 The anti-GM (genetically modified) groups seem to be winning their battle against the introduction of the country's first GM food crop, a Bt brinjal hybrid, developed by Mahyco Seed Company, using Monsanto's transgenic technology. The regulator's (GEAC) approval of October 14, 2009, is most likely to be consigned to the cold storage for a few years at least The anti-GM (genetically modified) foods campaign gathered momentum in September 2009, anticipating the regulatory approval of India's first GM food crop, a Bt brinjal variety developed by Mahyco. The regulatory approval came on October 14, 2009. But this setback has not dented the enthusiasm of anti-GM groups. In fact, these groups stepped up their pressure so much the Minister of State for Environment and Forests (MoEF) Jairam Ramesh was forced to announce a nationwide public consultation process before the regulatory approval is implemented. Ramesh's consultation process, coordinated by Ahmedabad-based Center for Environment and Education (CEE) which started in Kolkata and moved to Bhubaneswar, Ahmedabad and Hyderabad in the last four weeks, has been an eye opener. Fearing that they will be shouted down, the normally reticent scientific community which primarily works for government-funded research institutions, has kept away from these public consultation process. The few dozen seed companies, including the developer of the Bt brinjal, too have kept away from these meeting leaving the field clearly for the anti-GM brigade. No wonder, every consultation meeting of Ramesh has been turned into a carnival with drum beats, brinjal garland and folk singers in attendance greeting the minister. At many venues, the minister was told to shut up vocal activist who told him to just listen to them as that was the intent of the consultative meeting. The run up to these meetings had public meetings organized by civil society groups which gave platform to both pro and anti-GM foods lobbies. However, the pro-GM voices have been confined to the sidelines by the relentless campaigners who used a mix of emotional farmers, civil rights activists and retired scientists to drive home the message that Bt brinjal is bad and more safety tests should be done under public watch before its commercial cultivation is allowed. Surprisingly, the BioAgri industry has been keeping quiet since October 2009. The members of the regulatory agency, the Genetic Engineering Approval Committee (GEAC) in the MoEF too has been reluctant engage in any discussion. For this special report, BioSpectrum sought the views of every member of GEAC and their cryptic reactions are included in this special feature. Along with it , there is an overview of the tumultuous meetings on Bt brinjal from across the country that happened in the last five weeks. Protests greet minister at Bt brinjal meetings The first round of public consultations on the genetically modified Bt brinjal was held in Kolkata on January 13, 2010 at the Bose Institute, in which the Union Environment Minister Jairam Ramesh heard opinions of scientists, farmers and research scholars on the issue. Ramesh said he was holding the first consultation in Kolkata as West Bengal yielded 30-35 percent of brinjals cultivated in the country. The minister clarified he was not judging the future of technology but that he had been given the mandate to get public feedback. Kolkata University teachers said if government wants to stop the genetically modified crop cultivation, there should be some sense of inquiry. And if it is accepted then India should start slowly in a small-scale and that constant monitoring should be done. A group of scientists said forcible introduction of Bt brinjal would create economic and political disturbances. Written representations were also submitted to the minister who said he was willing to receive mails on the issue too. Bhubaneshwar Widespread protests marked the visit of Minister Jairam Ramesh, to the national consultation on commercialization of Bt brinjal in Bhubaneshwar on January 16, 2010. In a novel method of registering their resentment to attempts to allow commercial production of Bt brinjal in the country, hundreds of women under the banner of Orissa Nari Samaj (ONS) took out a funeral procession of Bt brinjal. They set a model of Bt brinjal on fire. Raising slogans against the scientific community and multinational companies, the ONS members exhibited indigenous varieties of brinjal, which they claimed was produced with the use of organic manure. â€œThe act of trading science for money has proved beyond doubt that it has spoiled the planet and consequently there is global warming. Doomsday may not be far unless the people's movement brings a halt to the act of these destroyers of indigenous seeds,â€? said G. John, executive director of Thread, an NGO that spearheaded the mass movement against genetically modified food crops. Women members also held a parallel consultation meeting where they opposed the introduction of Bt brinjal saying the approval by the GEAC was a conspiracy against farmers. Rights activists, scientists and other people from different walks of life addressed the gathering. ONS activists and members of other NGOs marched towards the venue to gift the minister organic brinjals. Various farmers' organizations from far away districts had reached the venue with placards to show their resentment to attempts to allow Bt brinjal in the country. Ahmedabad Over 1,200 individuals gathered at the JB Auditorium, Ahmedabad Management Association for the third round of the seven consultations on January 19, 2010. People also came from Rajasthan, Madhya Pradesh, Maharashtra and Gujarat to voice their concerns on the much debated genetically modified food crop. In the first session, out of 28 farmers who got to speak, 18 rejected Bt brinjal. In the second session, where scientists expressed their views and feedback, an overwhelming 13 scientists out of 15 scientists who spoke, took a stand against the entry of Bt brinjal. The minister spoke to an audience of over 500 stakeholders inside the auditorium while another 700 stood outside, waiting to be heard. The reactions at this round were similar to the ones seen in the earlier consultations. Stakeholders at the Ahmedabad consultations urged the Minister of Environment and Forests to stop Bt brinjal. Consumer representatives, youth, women, farmers, NGOs, scientists and academicians brandished banners and placards as they waited outside the auditorium. 'Let me choose what I eat', 'We are no lab rats', 'GM food an attack on the environment' were some of the messages given to the minister at the consultation. The minister suggested that Ahmedabad was important because Bt cotton was successful here. He assured that the ministry was in no hurry to come to a conclusion, and would not take a decision in a closed room. Hyderabad Jairam Ramesh faced similar but more aggressive protests of farmers in Hyderabad demanding that the government reverse its decision. The protesters from Left-affiliated farmers' outfits and Swadeshi Jagaran Manch (SJM) raised slogans like â€œBt go backâ€? and mobbed the minister on the dais at an event organised at the Central Research Institute for Dryland Agriculture (CRIDA) in Hyderabad. Those supporting Bt Brinjal also raised slogans in support of their demand, resulting in chaos. Additional police forces were called into the venue to rein the agitators. As the protesters left the hall, Ramesh regretted the incident as no such scenes were witnessed at other public hearings held earlier. He however asserted that he will not come under the influence of any company or NGO. The minister said he wanted to hold an impartial public consultation over the matter. The final decision on the matter would be taken after holding fair public hearings on the issue in other states. These four consultations seem to have set the mood for the remaining ones. As the consultation process moves ahead, the country hopes to hear a lot more NOs to Bt brinjal. 7 states show â€œred flagâ€? to Bt brinjal In a major setback to the BioAgri industry, seven major states which together account for more than 70 percent of brinjal cultivation in the country have said an emphatic â€œNoâ€? to the introduction of Bt brinjal. Mararikulam is a popular beach town on the Kerala coast in Alappuzha district, famous for its backwaters. But this year, the New Year revelry was replaced with an unusual event, called the Mararikulam Brinjal Festival, organized by Mararikulam North Panchyat. Thousands of activists and local citizens visited the festival which showcased a few hundred varieties of brinjals grown in the country. Interestingly, brinjal is not a popular vegetable in the coastal state. Attended by Kerala's state ministers and hundreds of anti-GM (Genetically Modified) food activists, at a big public meeting, it was decided to strongly opposed the introduction of the country's first GM food crop, a transgenic hybrid brinjal variety developed by Maharashtra Hybrid Seed Company (Mahyco) which has been given the regulatory approval on October 14, 2009. Kerala's finance minister, Thomas Issac, declared the intention of the state to keep it â€œGM freeâ€? and not allow cultivation of Bt brinjal variety. This announcement came on January 2, 2010, just a day before Prime Minister Dr Manmohan Singh arrived in Kerala's capital city of Thiruvananthapuram to inaugurate the annual Indian Science Congress session. Perhaps, taking a cue from the swelling public opinion against Bt brinjal, Dr Singh called for caution on this front in his speech. â€œThe technology of genetic modification is also being extended to food crops though this raises legitimate questions of safety. These must be given full weightage, with appropriate regulatory control based on strictly scientific criteria.â€? In the normal circumstances, this would have been an innocuous statement by the PM. But the statements made in these two coastal cities of Kerala have sent ripples through the country. And there is now a clamor among chief ministers in other states to join the anti-Bt brinjal bandwagon. So much so by the end of Janaury, seven states have declared that they will not allow cultivation of Bt brinjal even if the central government gives the final clearance for its commercial cultivation. Kerala is ruled by a coalition of left parties. West Bengal, another left ruled state, was the next to join the â€œNo Bt brinjalâ€? corus with the Chief Minsiter Budhadeb Bhattacharya, showing the â€œred flagâ€? to the transgenic brinjal variety even as Environment Minister Jairam Ramesh kicked off his nationwide public consultation process from the Kolkata in early January. The ripples then reached the adjoining state of Bihar where the Chief Minister Nitish Kumar, said â€œnoâ€? to Bt brinjal for the moment. He said the issue was carefully considered by the Rajya Kisan Ayog (state agriculture commission), which, after deliberations with farmers, agricultural scientists and agricultural officers was of the opinion that there should be an adequate number of trials to see its performance in different agro-climatic conditions in the state. Orissa was the next state to say no to Bt brinjal. Within a few days, Karnataka's Horticulture Minister Umesh Katti publicly expressed his preference for traditional varieties brinjal which are grown in the state and cautioned against the introduction of Bt brinjal in the state during a meeting with farmers. â€œI have instructed the officials to encourage and prepare a blueprint to develop our own varieties of brinjal. We have seen the plight of Bt cotton and its consequences. Why introduce Bt brinjal and bear that again?,â€? Katti said. Within a few days, Karnataka Chief Minister B S Yeddyurappa approved Katti's stand and told a delegation of anti-GM groups which met him on January 25 that state would not allow the transgenic varieties of brinjal for cultivation. â€œThe state is the 5th largest producer of brinjal in the country. We are growing more than 40 varieties of brinjal. We will not allow anything that may put our farmers in a difficult spot,â€? said the chief minister. Soon leaders of other brinjal growing states like Chhattisgarh, Madhya Pradesh and Andhra Pradesh also made public announcements against Bt brinjal. Interestingly, of these seven anti-Bt brinjal states, six are ruled by parties opposed to the central government run by the Congress party. The 7th â€œno Bt brinjal stateâ€? Andhra Pradesh is run by the Congress party. Tamil Nadu, a partner in the ruling coalition in Delhi, has called for caution on the issue. Voices in the wilderness on Bt brinjal As the anti-Bt brinjal juggernaut which has dozens of civil society groups, environment organizations, a range of non-governmental organizations (NGOs) corner the entire media attention in the last five to six weeks, a small group of agricultural experts have been making some attempts to get themselves heard in the din. â€œWe are scientists. We cannot win a shouting match with the activists at the public consultation caravan that has been going around the country,â€? said a dejected Prof Kameswara Rao, a retired agricultural scientists and now secretary of Bangalore-based Foundation for Biotechnology Awareness and Education (FBAE), a biotechnology advocacy group. However, the group which has some of Karnataka's best agricultural scientists as members, rebutted every issue raised by anti-GM activists with scientific facts, at a meeting with the media. Even when the agricultural scientific community in the wide network of publicly funded laboratories keep quiet and the BioAgri industry itself not very vocal about Bt brinjal, FBAE has joined the debate in a healthy way. These are some clarifications provided by FBAE on the Bt brinjal issue: Bt brinjal helps in reducing the cultivation expenses on the use of synthetic pesticdes up to 77 percent, benefiting millions of farmers by enhancing marketable yield. The consumer gets health fruit and value for money paid. It also greatly reduces the risk from synthetic chemicals to the farmers, consumers, non-target organisms, soil, water and environment in general. Bt brinjal has passed through the prescribed mandatory bio safety tests according to Indian regulations. Two expert committees reviewed the bio safety dossier. The second committee concluded on October 8, 2009, that the Bt brinjal with event EE-1 ( Cry 1 Ac) has been extensively tested for its bio safety and no additional studies/review are necessary. Based on this, on October 14, 2009, the Genetic Engineering Approval Committee (GEAC) approved Bt brinjal for commercialization. However, the Minister of State for Environment and Forests (MoEF), had opted for further consultation with different stakeholders, which virtually overrides the decision of the GEAC. All the stakeholders had already involved themselves on the issue of Bt brinjal for about five years. The stand taken by the MoEF has created a lot of regulatory uncertainty for no valid scientific or environmental concern. No technology developer can afford to operate in the country to develop any biotech crop with such an uncertainty of an approval process that is not based on science. The charge sheet by activist include several issues, such as that a) genetically engineered (GE) crops are toxic and allergenic, b) they harm non-target organisms, c) gene flow from transgenics eliminates related varieties/species, d) they become super weeds and eliminate all vegetation, e) they negatively impact ecology and bio diversity, f) there is a terminator gene in GE crops affecting farmers' interests, etc. They even attribute farmer suicides to failure of GE crops. There is extensive scientific literature that amply demonstrates that there is no truth in any of the above charges and allegations. The activist make an emotional argument that India is the country of origin of brinjal, for which there is no scientific evidence. The opposition to Bt brinjal means to India nothing but a reduced marketable yield, an increased use of pesticides (with economic as well as health damage to farmers, consumers and environment). The government should decide whether to help Indian farmers or pesticide producing corporations. N Suresh & Jahanara Parveen in Bangalore ]]> <![CDATA[Human trials for H1N1 vaccine start in India]]> https://biospectrumindia.com/news/95/8056/human-trials-for-h1n1-vaccine-start-in-india.html https://biospectrumindia.com/news/95/8056/human-trials-for-h1n1-vaccine-start-in-india.html Thu, 04 Feb 2010 17:50:00 +0530 In a positive step towards the approval of H1N1 vaccine, Sanofi Pasteur has started the first ever human trials of a swine flu/H1NI vaccine for Indians on January 20, 2010, at three places. The vaccine will be tested on about 100 Indians for three weeks at three hospitals in Pune, New Delhi and Chandigarh. Sanofi Pasteur has received the approval for conducting human trials from the Drug Controller General of India (DCGI). Sanofi’s vaccine was developed in France and has been tested on Europeans. However, the DGCI wants to make sure Indians respond well to the vaccine before giving approval for the sale of this vaccine. Sanofi Pasteur had acquired a majority stake in Hyderabad-based vaccine maker Shantha Biotechnics in mid 2009. After three weeks of trials, the DCGI will wait for another six weeks to check whether or not there were any side effects on all the 100 people who were part of this trial exercise. Three Indian companies—Pune’s Serum Institute, Ahmadabad-based Cadila and Hyderabad-based Bharat Biotech have been contracted to develop swine flu vaccine and their research is in various testing phases. Meanwhile, Bharat Biotech has commenced phase I clinical evaluation of HN-VAC, its cell culture-based H1N1 vaccine candidate. The company has received the nod from DCGI to conduct the phase I clinical trials. In August 2009, the Indian government approached four international pharmaceutical companies that were manufacturing H1N1 vaccine, but no pre-bookings were made. The government said the booking would be made only after conducting the clinical trials to ensure the safety and efficacy of the vaccine in the country. In the first week of December 2009, GlaxoSmithKline (GSK) got the approval to start its clinical trials in India. Two other pharmaceutical companies, Baxter and Novartis also got the approvals to conduct clinical trials. French drug company, Sanofi Aventis’ vaccines division, Sanofi Pasteur, is one of the international companies that are expected to join hands with the government in the fight against swine flu. Speaking to BioSpectrum, Dr Vishwa Mohan Katoch, director general, Indian Council of Medical Research (ICMR), says, “The government is very cautious in its approach and would not like to take any action in a hurry as the matter is directly linked to people’s health. Proper trials are a must so that all the safety issues are addressed before the release of vaccine in the market. First time in India, all precautions have been taken and the maximum safety needs have been addressed in this regard.” Dr Katoch, also the secretary of the Department of Health Research, Ministry of Health and Family Welfare, says, “Increase in the number of positive swine flu cases, has put a lot of pressure on the government to look for an early vaccine trial and making it available in the market.” “There is an ethical committee in every company and the volunteers of 2-200 per group have been used to check the bridge effect and the adverse effect. Primarily, the health workers are being targeted for the trials as they are at the higher risk and later on other segments of population will be involved,” adds Dr Katoch. ]]> <![CDATA[Opportunities for Indian biosimilar players]]> https://biospectrumindia.com/news/95/2702/opportunities-for-indian-biosimilar-players.html https://biospectrumindia.com/news/95/2702/opportunities-for-indian-biosimilar-players.html Thu, 04 Feb 2010 17:41:00 +0530 From India's perspective, we must first understand that the opportunity for Indian biosimilar players is in four key growth segments of products, services, technology and applications When we say biosimilars, we tend to think about products and services segment, however, we seem to forget the applications and technology development segment. Some of the examples include: Biosimilars product segment: Peptides, recombinant glycosylated proteins, recombinant non-glycosylated proteins and others. Biosimilars service segment: Drug development, contract research, manufacturing services and clinical trials services. Biosimilars applications segment: Oncology, infectious diseases, chronic and autoimmune diseases, and other diseases which are typical to Indian genome which incidentally contains Indo-European, Dravidian, Tibeto-Burmese, Austro-Asian and covers almost 65 percent of world's population that has 90-95 percent similar Indian genotypes. Biosimilars technology segment: Recombinant DNA technology, monoclonal antibodies technologies, protein sequencing, bioassay, chromatography, nuclear magnetic resonance, and mass spectrometry. In order to gain a fair share of the global biosimilars products, services, technology and applications market, Indian biosimilar players would need to invest heavily in creating alliances and discovery. Looking at the biopharma patent expiries, Epoetin, Human Insulin, Human Growth Hormone (HGH), Colony Stimulating Factors (CSFs), Interferon Alpha and Beta are the key products that would offer huge opportunity if Indian players are able to manage the time to market. While there is still unclear regulatory hurdles that Indian players would need to clear in the US and Europe, players who are able to pre-empt would be successful in these major markets. Let us not forget that in the biosimilars services space, India does have the advantage over other Asian countries such as China, this is fast diminishing and eroding. Indian companies likely to succeed in the biosimilar market need to have an appropriate marketing structure as well as the financial resources to develop the products and to accept higher upfront risks in development, commercialization and capital investment. Hurdles for Indian players The process to develop a biosimilar -essentially generic version of biopharmaceuticals – is more complex than that of developing a generic copy of a chemical-based compound. The regulatory pathway is not completely finalized both in the US and EU which are the largest markets for biosimilars. Apart from the regulatory and clinical development hurdles that are costly and time consuming, Indian players need to upgrade their capabilities as their organizations mature. Some of these include joint venture and alliance management for collaborative research, contract research, contract manufacturing, developing technology transfer management, marketing arrangement for biosimilars globally, to name a few. The biosimilar market will be characterized by price competition, even when there is only one or a very limited number of players for biosimilars. This will constrain the commercial opportunity. Even a small price difference reduces the incentive to switch. The consensus seems to be that a 20-25 percent discount is optimum to increase the switch back. Hence the ability of the Indian players to be cost-competitive producers of biosimilar products, services, applications and technology will enable them to lock in the customer and the final consumer. The required capital investment and operating costs of manufacturing will be much higher for biosimilars than for generic drugs. Some of the key players in India have been able to raise capital on the global scale, however, with the recent downturn, the ability of Indian players to sustain and raise capital seems suspect given their leverage and capacity to raise funds. Several potential biosimilars face competition from second-generation products with more convenient administration schedules. In many cases, the same biopharma or large pharma companies market the original and second-generation products and there may not be a marked difference in price. This would completely erode the incentive for Indian players to launch products that are price competitive, given their R&D and development investment loading. Improved delivery devices can add significant value and enhance product differentiation. There are, however, a limited number of drug delivery companies, many of which are already working exclusively with the branded incumbents. This would restrict the options for Indian players trying out newer delivery systems as part of the differentiation and patenting. Entry into EU and US Entry barriers are relatively low and there tends to be severe price competition from several generic competitors reducing sales significantly after the first year of presence in the market. It is not clear if there will be enough biologic candidates for a company that is focused on launching biosimilars to sustain growth. There are not enough possible biosimilars for a company to rely on these alone to launch a new product every year. Biosimilar players will therefore need to adopt different business models and skill sets from those of conventional generics companies. Other regions that Indian players can target include countries like Japan, Canada, Mexico and Latin America. Global competition Many countries are now realizing the need for biosimilar regulation to control and manage the growth of biosimilars in their country. Around 15 to 20 countries have put in some sort of guidelines in place. These countries are in the race and also potential competition to Indian players. — Kapil Khandelwal The author has over 20 years of industry and consulting experience of connecting the healthcare and life sciences value-chain from early drug discovery, drug development, care delivery, healthcare providers, intermediaries to payors. ]]> <![CDATA[Bigtec making inroads into point of care diagnostics]]> https://biospectrumindia.com/news/95/1928/bigtec-making-inroads-into-point-of-care-diagnostics.html https://biospectrumindia.com/news/95/1928/bigtec-making-inroads-into-point-of-care-diagnostics.html Thu, 04 Feb 2010 17:32:00 +0530 Bigtec Labs has developed a handheld diagnostic platform for rapid pathogen detection of any disease and allows DNA amplification. Currently, the company is validating the product specifically for hepatitis B, C and HIN1 where with a single drop of blood the diagnosis can be made within minutes The Society for Innovation and Development (SID) Entrepreneurship Center at the Indian Institute of Science (IISc) has housed several companies engaged in biotech research. While many have moved out of the campus and setting up their own dedicated facilities, others continue to reside there as they believe the air in IISc is driving innovation in their labs. Bigtec, a biomedical diagnostic research and development company in SID develops simplified diagnostic kits utilizing the disciplines of microelectromechanical systems (MEMS), optics, molecular biology, bioinformatics and information technology. It has associated itself with scientists at IISc and other such renowned research institutions in the areas of infectious diseases and nanotechnology. Headquartered in Bangalore, Bigtec Labs was founded in 2000. Its core competencies range from the integration of chemistry, nanobiotechnology and MEMS to genetics and science/ engineering. The research-based organization is constantly exploring new frontiers while also tackling the current real world issues and making inroads into the future. This is evident from the fact that the company is currently at an advanced stage in the realization of a MEMS-based nucleic acid amplification platform that can be extended to diagnose several diseases including the H1N1. Such a system can be tailored to accept whole blood samples or samples with minimal processing, extending the diagnosis capability to remote locations with minimal facilities. Using this platform, results are available in a few minutes, making it an ideal platform for doctor's office disease monitoring, thus enabling a paradigm shift in modern healthcare and diagnostics. The project is supported by the New Millennium India Technology Leadership Initiative (NIMITLI) from Council of Scientific and Industrial Research (CSIR), Government of India. This tripartite research program commenced in January 2006 with Bigtec Labs, supported by Indian Institute of Science and Indian Institute of Integrative Medicine, Jammu. A monitoring and advisory committee had the research scrutinized at every stage of progress. Bigtec Labs' handheld point-of-care diagnostic equipment is designed to bring the power of bench top laboratory equipment to the clinician by providing rapid, low-cost near-care diagnostics. “Our battery operated, real-time micro-PCR is poised to revolutionize medical analysis and treatment in-field, and in the laboratory, by reducing the analysis time and driving down the cost of medical diagnostics by orders of magnitude,” claims Chandrasekhar Nair, director of Bigtec Labs. Using the state-of-the-art MEMS technology, the device is slated to be at the cutting-edge of medical diagnostics for years to come. “This is in keeping with our vision of providing accurate, affordable diagnostics at point of care,” he adds. “The platform is designed for the diagnosis of infectious diseases irrespective of whether the causative organisms are bacteria, virus, fungi or parasites. “Independent, third party validations of our device for hepatitis B detection has been completed successfully by an organization certified as a Center for Excellence in Liver Diseases by the Government of India. Multi-centric clinical trials at internationally-renowned centers will commence shortly,” shares GM Kini, co-founder and MD, Bigtec Labs. India has around 80 million hepatitis-B positive people and it is estimated that around 300 million tests are conducted annually. “Our platform is affordable for both healthcare providers and patients. A real-time PCR platform costs lakhs and a confirmatory hepatitis test on PCR costs in thousands. The Bigtec platform will be made available for approximately Rs 1 lakh and a test would work out to only in hundreds,” shares Nair. Capitalizing on the multiple applications of BioMEMS, the company is also working towards replicating the chip for diagnosis of chikungunya, dengue, malaria, HIV and HPV. The novel Micro Thermal Cycler Diagnostic Platform (MTCDP) is also being recommended to extend its use for H1N1 detection for the surveillance/ diagnosis of swine flu. Discussions on H1N1 detections at transit points using Bigtec Labs' platform have been initiated with a nodal government laboratory. The validation will be completed next month after which the company will release the first prototype for custom manufacture. The company intends to license the technology for production and discussions are on with players in India and abroad. Currently, Bigtec Labs is operationalizing a go-to-market strategy. However, it will be looking for an ideal marketing partner. Commenting on the business model, Nair says, “Bigtec Labs' business model is to translate laboratory technologies to completely validated market-ready technologies and go-to-market with these technologies through appropriate collaborations, while addressing certain markets ourselves.” The nine-year-old Bigtec Labs is still in a pre-revenue mode. The company also has SAP consulting and software development arm named Deciphar. The company's revenue streams are from SAP business services, software engineering training and consulting, and phase I clinical trial software sales. However, its value-added assignments are in the areas of biotherapeutics and handheld point of care diagnostics. The company uses internal source of seed funding earned from its IT consulting and services arms for incubation activities in the areas of bioengineering. — Jahanara Parveen in Bangalore ]]> <![CDATA[â€œCell therapy needs more encouragementâ€?]]> https://biospectrumindia.com/news/95/2545/cell-therapy-needs-more-encouragement.html https://biospectrumindia.com/news/95/2545/cell-therapy-needs-more-encouragement.html Thu, 04 Feb 2010 17:26:00 +0530 —Satyen Sanghavi, chief scientific officer, RMS Regrow, Mumbai Cell therapies are emerging as the promising treatment now-a-days as it helps to overcome the limitation of the existing treatment options. Mumbai-based Regenerative Medical Services Regrow (RMS Regrow) in partnership with a South Korean company is exploring the possibilities of cell therapy in India. In a tete-a-tete with BioSpectrum, Satyen Sanghavi, chief scientific officer, RMS Regrow, talks about his company's working model and partnership with South Korea-based Sewon Cellontech. He  also shares his views on the unstructured regulatory system for stem cells and cell therapy in India Can you tell us about the genesis of RMS Regrow?   The genesis of the company goes back to the time when I was looking out for a subject for my thesis, while I was pursuing my masters in the UK.  Back then, we had a module on stem cell technology and I was interested in the module because it involved tissue engineering and cell culturing. Plus, when I came back to India in 2008, there were small talks about stem cell technology. That is when we came across a South Korea-based company, Sewon Cellontech and we entered into a partnership with them. Sewon Cellontech develops technology on stem cells and was also licensing out their technology services to various other companies. We got the license from them for Chondron, Ossron and Babycell and as RMS Regrow brought its services here in India. When we were working in partnership with Sewon Cellontech, we realized that it was possible to send the cells to South Korea for culturing and then subsequently they send it back to us in the stipulated time period. Out of the three services offered by RMS Regrow — which has a good market uptake?   The Babycell technology which focuses on cord blood banking services, brought to India three months back, has picked up in the market. However, for the last one-and-a-half-year, it is Chondron, an autologous biological therapy involving the patient’s own cartilage tissue harvest and Ossron cell therapy, an autologous biological therapy involving the patient’s bone marrow harvest, which is more interesting even though Babycell has a larger share. We work on a servicing model. We provide the three services to orthopedics. So, today when a patient walks into a clinic with a knee pain and is assessed with cartilage damage, the doctor himself may suggest the cell therapy. He will then connect with us to culture the cells. Then there are processes like patient consent forms, hospital consent forms and ethics committee forms. Once we do a biopsy, the cells have to reach the lab within two days.  We then send the cells for culturing to Korea and now to our lab in Lonavala and then they send it back to us after culturing. How did you come up with the idea of setting up a lab in India? When we started out with RMS Regrow, we worked out on the logistics with our partners. Initially, it was such that there were just four of us. I would handle the logistics and would be in close interaction with the doctors. So, we would know exactly which hospital would start the therapy with which doctor and then accordingly make arrangements for sending the cells for culturing to Korea. We had to handle operations in a very sophisticated manner because we did not want anything to go wrong. We then started recruiting cell engineers from reputed medical colleges.  We then sent them for training to Korea for three months and then sent another batch. That was the time when we started constructing a lab. So in nine months since inception of operations we took up land in Lonavala. By the time we finished the cases in Korea, it gave a chance to each and every surgeon we were in touch with, a case to perform and get hands-on experience on cell therapy.   We started up the lab four months back. So the difference between culturing cells in Korea and that in the lab in India is that — cells sent for culturing in Korea cost around Rs 3 lakh  but at this lab it costs only around  Rs 1.5–2 lakh. We have done 8-10 cases in our lab here. So from now on, all the cells will be cultured in this lab. Before going ahead with cell therapy on a patient, does it need to go through any regulatory approvals? The requirement was a few results from the initial case studies conducted on patients. Sewon had done their human clinical trials with successful results and since we are partners it applies to us. However, in India, we had to go to the medical regulatory authorities and keep them in the loop before going ahead with any case. Initially, we did inform them several times before a case and also asked written permission for a go ahead. But no regulatory agency in India is ready to give the stamp for a go ahead for cell therapy because they are not aware of the regulations and everyone is scared of giving the go ahead in case something goes wrong in the future. Looking at the uncertainty, today when a doctor is ready to give the treatment when conventional treatments fail, the patient is ready and we are ready to get the cells cultured, we go ahead with the case study. Now we have only an independent ethics committee that comes into the picture. Human trials for these services have been done in Korea. Any plans to do it in India? In South Korea, human trials on 800 patients were conducted. However, in India, regulatory authorities have queries that if this works in South Korean patients, will it work on Indian patients too and whether safety results can be shown. So, the first 10-12 cases where we sent cells to be cultured in South Korea was enough to show these authorities that this works on Indian patients as well. In cell therapy, we do not need to show a diverse patient population study. The trials can be conducted in one country and applicable throughout out the world. So, the regulatory authorities here need to have an open mind. Any collaboration apart from Sewon Cellontech? Sewon is a big company and a valuable partner. They have so many projects in the pipeline and have more than 600 people working under them. Plus, they have business in power, agri and biotech. We already have an established partner on their services. We are looking at different other options and are trying to develop cells ourselves, because collaboration brings in additional cost. Now, we have the expertise and technicians who are well trained and have the caliber to develop technologies on their own. Is the absence of a regulatory framework a hurdle for RMS Regrow? For stem cells, there is already a draft of guidelines but the government is not ready for a regulatory framework. When we wanted to start RMS Regrow, we went to all the regulatory bodies from the lower order right up to DCGI. But they told us different things and that was because they had less knowledge about the subject. But even now when they do have knowledge about the processes for cell culturing there is no separate guideline for cell therapy. The guidelines applicable for drugs apply for cell therapy too. But there is a huge difference between a drug and a patient cell. Is there a co-relation between other businesses under the Satyan Group of Companies? My father started Satyan Pharmaceuticals and has been running it for 25 years along with our insurance company.  But there is no co-relation between the three businesses we have right now. Satyan Pharma is into active pharmaceutical ingredient (API) sourcing in South Korea, Singapore and China. We are authorized agents to more than 25 manufacturers here in India. The company has around 22-25 people and the turnover is Rs 500 crore. Then my father felt the need to move to biotechnology because there are not many pharma drugs in the pipeline and big pharma growth is stagnating. There is lot of biotech research happening around the world. So as a strategic decision, RMS Regrow is a way forward for Satyan Pharma. How does the future look like for RMS Regrow?   We are soon going to start a new therapy service for spinal chord and this will be the use of stem cells where it is easily available. We are expecting a turnover of Rs 10 crore by 2012. In the first year it was Rs 1 crore so it has been quite a growth. We are also looking at developing our own in-house R&D team without any collaboration. Case Study It started with an acute pain on the left knee for state level (Madhya Pradesh) cricketer, Ankit Parashar.  A  21-year-old middle order batsmen,  having a budding career, Parashar’s knee pain become unbearable and his performance  was affected when he was unable to squat while wicket keeping. He feared that this woulde end his career. He was diagnosed with Osteochondritis Dissecans (OCD), a joint disorder in which cracks form in the articular cartilage and the underlying subchondral bone. In such a condition there is no blood supply to the bone. Parashar then approached Dr Anant Joshi, an orthopedic surgeon with specialization in arthroscopy, sports medicine and more famously known to be the medical advisory to the BCCI. He then used Regenerative Medical Services Regrow’s (RMS Regrow) new technology for cartilage repair therapy Cartilage RMP— Chondron, a procedure where the patient’s own cartilage tissue from the healthy articular cartilage is collected, cultured in a lab for 4-6 weeks and then implanted back into the defective area of the cartilage. In Parashar’s case, after a biopsy, his cells were cultured for six weeks in a lab in South Korea before it was sent back and implanted in the injured area. “I am hopeful that such a technology is the answer for many athletes who had to end their careers due to repetitive injuries,” comments Dr Joshi. Parashar will be back in action by next month and also hopes to make it to the Indian National cricket team. ]]> <![CDATA[Stem cells-The future of therapy]]> https://biospectrumindia.com/news/95/4176/stem-cells-the-future-of-therapy.html https://biospectrumindia.com/news/95/4176/stem-cells-the-future-of-therapy.html Thu, 04 Feb 2010 17:22:00 +0530 The discovery of stem cells is one of the biggest achievements in modern medical history. Stem cell-based researches are conducted almost every where in the world and has triggered interest in India too. The promise of regenerating anything from head to toe using stem cells is luring Indian companies. An overview of the stem cell sector in India. Stem cell are being called as wonder therapies for their innate quality in regrowing anything within and outside the body from head to toe. Currently available therapies are only ‘symptomatic’ in nature and do not address the root cause of the disease. But stem cell therapy aims at addressing the root cause of the disease by replacing the damaged or diseased cells by healthy functional cells there by offering possible cure for unmet medical needs. Stem cell market scenario Indian stem cell companies and research institutes are known for their innovation and R&D expertise. The successes of these companies have encouraged start-ups to enter this promising new sector. Toppers of the prominent stem cell companies share their views on the current trend and future prospects of stem cell research in India. Bangalore-headquartered Stempeutics Research, a part of the $3 billion (Rs 13,889 crore) diversified Manipal Group, is one of the leading stem cell companies in India. The company is in the process of bringing the first stem cell therapy product in India. While the initial foray of Stempeutics is in bone marrow derived mesenchymal stem cells, Stempeutics is investing heavily on its R&D to bring out some innovative products such as tailor-made cells based on adult stem cells. It is working on alternate sources like Wharton’s Jelly, adipose tissue, and dental ligament for mesenchymal stem cells. The company is also investing on leveraging human embryonic stem cells for therapeutics purpose. Stempeutics is also focusing on enhancing the upscaling process of mesenchymal stem cells using latest technology in order to bring down the cost of the end product. According to BN Manohar, president of Stempeutics Research, “Stem cells would be a major branch of medical treatments and would be a standard cure and practice in the years to come. Regenerative medicine is a rapidly emerging area of biomedical research with enormous therapeutic potential, and this would be an ideal supplement for existing medical treatments. “The global market for stem cell therapies is expected to be $20 billion (Rs 92,593 crore) by 2010. Adult stem cell therapy currently dominates the global stem cells market with a share of almost 58 percent. There are almost 30 prominent adult stem cell companies in the world. Majority of these companies are based out of the US, followed by the European Union, Israel, Thailand, Canada and Australia,” Manohar says. Prominent stem cell companies outside India are Osiris, Organogenisis, Genzyme, Cytori, Aastrom and Theravitae. Mumbai-based Reliance Life Sciences, which is owned by Mukesh Ambani led Reliance Group, has been a pioneer in stem cell research in India and the company focuses on developing stem cell therapies, right from research, cell processing in cGMP facilities, clinical research and clinical practice. The company is developing a wide range of novel research-led, autologous and allogenic cell therapies and tissue engineered products. Cell-based therapies from Reliance Life Sciences aims to fulfill unmet patient needs in the areas of cardiac disorders, neural degeneration, spinal cord injury, metabolic disorders like diabetes, ophthalmic diseases, hematological diseases, oncological diseases, burns and wound management, diabetic and venous ulcers, and cartilage disorders. While commenting on the Indian scenario of stem cell therapy, KV Subramaniam, president and CEO, Reliance Life Sciences, says, “India is one of the few countries in the world pursuing stem cell research. But regenerative medicine, comprising stem cell therapies and tissue engineered products, is at a nascent stage in India. According to our estimate, by 2011 about 16.44 crore patients, suffering from diabetes, cardiovascular disorders, neurological disorders, burns and wounds, osteoarthritis, osteoporosis, bone, cartilage (joints & replacements), liver disorders, congenital abnormalities and neoplasms, would benefit from stem cell therapies in India.” “Presently, stem cell therapies have good potential in ocular, cardiovascular, and neurological disorders. There are several companies and institutions engaged in various clinical trials of stem cell research. With growing interest of private companies in this domain and support from government bodies, stem cell therapy holds great potential to emerge as the therapy for several diseases in future,” adds KV Subramaniam. Chennai-based Nichi-In Center for Regenerative Medicine (NCRM) is an Indo-Japan joint venture institute carrying out research, training and clinical applications-protocol development in regenerative medicine, with an emphasis on stem cells, progenitor cells and autologous adult cells with regenerative capability to take them to clinical application, while maintaining the highest ethical and scientific values of international standards. NCRM is the first institute in India to start providing autologous NK cell based immuno-cell therapy (AIET) for cancer and has been providing stem cell isolation, enrichment and expansion services to partner hospitals all over India for various diseases as per Indian Council of Medical Research (ICMR) guidelines. “Indian stem cell market is quite big. However, we have to educate the public about the possibilities and limitations of the cell-based therapies. With a huge population where lifestyle-related diseases are increasing and with rapidly increasing death rate due to cardiac diseases and cancer, more emphasis is needed for all those diseases that are prevalent in India,” says Dr Samuel JK Abraham, director, NCRM. Bangalore-headquartered Cryo–Save India is a part of Cryo-Save Group, Europe’s largest adult stem cell storage bank. The company recently achieved a significant milestone with TUV Rheinland, Germany, conferring the Indian operations an ISO 9001:2008 certification. “India, as a country, is much more developed and advanced in medical science. It has adapted to the modern medical science than any other Asian countries. With easy accessibility across the nations, India has emerged as the ideal hub for the industry to grow. Considering the growing population in the country, the market is huge and is expected to grow at a rapid pace,” observes VR Chandramouli, managing director, Cryo-Save India. “Stem cell banking in India is yet to come under a regulatory frame work where government bodies need to spell out the clear-cut procedures for storing the stem cells. As a first step, senior officials at the Ministry of Health and Family Welfare need to lay the process together with the help of an expert committee for stem cell banks and therapy,” adds Chandramouli. Streamlining guidelines ICMR and the Department of Biotechnology (DBT) had laid down the fundamental guidelines for stem cell research and therapy in 2007, but in the absence of laws specific to the issue, the guidelines were set aside. Apparently in India we are in a stage to formulate the norms governing stem cell banking and the storage procedures, opines Chandramouli. The guidelines put forth jointly by ICMR and DBT have not become a law so far. Government needs to create a separate task force on stem cells research and therapy and see how India can leverage its intellectual talent and become a global leader in this field. In countries like Malaysia excellent support is provided by the Malaysian Biotechnology Corporation. It provides seed funding, R&D funding and export funding for start-up companies (BioNexus Status Companies). Also it provides 10-year tax benefits from the year the company starts making profit, duty exemptions and a host of benefits for promoting stem cell companies. Indian government should provide these benefits to stem cell companies based on certain evaluation. Also on stem cell clinical trials front, government needs to think on fast track approval process considering it as ‘orphan’ drug status – like what FDA is doing in the US, suggests Manohar of Stempeutics. Future forward India needs to speed up its activities related to human clinical trials (as per cGCP standards). There are only few dedicated companies focusing on real research and clinical trials. The current stem cell therapy market in India is approximately $540 million and it is expected to grow rapidly. The country is also becoming an attractive destination for global stem cell companies and research institutes in the areas of clinical trials/clinical research, stem cell research and contract manufacturing. Recent approval of clinical trials of stem cell-based drugs by the Drug Controller General of India (DCGI) has created immense interest among global stem cell players to conduct their clinical trials in India. Well-defined guidelines, efficient and speedy processes for approving clinical trials by regulatory bodies and availability of vast patient pool makes India a good destination for conducting clinical trials. ICMR supported by DCGI has drafted guidelines to conduct clinical trials in India in an ethical and scientific manner. ICMR has formed an expert stem cell committee to validate and recommend trials in India. DCGI recently made registry of all clinical trials mandatory with Clinical Trials Registry- India (CTRI) registry – so that all trials can be monitored for proper conduct as per international norms. Availability of skilled manpower and initiatives taken by the government in creating good infrastructure for stem cell research are attracting foreign institutes and private companies for collaborative research with Indian institutes and private companies. The initiative taken by the DBT in creating a world-class stem cell research center in Bangalore is another positive step in nurturing value-added stem cell research in India. Another area where India can take a lead in stem cells is the stem cells production technology i.e. large scale upscaling of stem cells. It is an area where private players can take a lead in the global market in the next three to four years. Global stem cell players may outsource their ‘production’ process to India if India can show the cost/quality advantage. India has the opportunity to be a global force in biotechnology and stem cell research can be an important constituent of this aspect of global leadership in this frontier technology area. — Pradeep Kumar in Bangalore ]]> <![CDATA[â€œTBVI is developing booster BCG vaccinesâ€?]]> https://biospectrumindia.com/news/95/2444/tbvi-is-developing-booster-bcg-vaccines.html https://biospectrumindia.com/news/95/2444/tbvi-is-developing-booster-bcg-vaccines.html Thu, 04 Feb 2010 17:14:00 +0530 —Jelle Thole,director, TBVI , The Netherlands Tuberculosis or TB is the oldest disease known to science. Today, it is one of the biggest killers affecting almost two billion people. Far from being a disease of the past, around one-third of the earth’s population is infected, resulting in over nine million new cases and close to two million deaths annually. In 2007, Hannu Laang and Ole Olesen of the European Commission were the first to suggest the establishment of a separate entity to fund research for new vaccines to conquer tuberculosis. Less than a year later, on March 5, 2008, Tuberculosis Vaccine Initiative (TBVI) was established, a European-based foundation facilitating development of safer and more effective vaccines against tuberculosis. TBVI is based in the Dutch city of Lelystad and is headed by Dr Jelle Thole, its director since launch. Dr Thole in an interview with BioSpectrum shares his thoughts on various issues such as TBVI’s initiatives, funding and development partners. What are the major initiatives taken by TBVI to curb TB in the Asian countries? TBVI is developing vaccines that are useful to people all over the world and are not focusing on specific vaccines for Asia. There is no reason to have specific vaccine for Asia because the TB-related issues are common in nature. The current live vaccine that we use is Bacillus Calmette-Guérin (BCG) and this protects children up to five years from meningitis. What we are trying to do now is to develop vaccines that boost the second vaccination of BCG and improve the performance in adult population. We are also supporting a number of partnerships that develop these kinds of vaccines. The other type of vaccines that we are developing is the BCG replacement vaccine that will be used in children. BCG should offer long-term protection, however, it is entirely safe when it is used in HIV positive population.   Who are your major partners and how are those partnerships fulfilling your needs? We work with over 40 research partners in Europe, Africa, Asia and South-America and we have a variety of joint projects with them. We are supported by European Commission, Bill and Melinda Gates Foundation, FIT-BIOTECH and Institute Merieux. We aim for a portfolio of five programs with a budget of 200 million (Rs 1,302 crore) for the coming 10 years; in our first year of existence in 2009 we have raised about 15 million (Rs 97.69 crore). How do you operate internationally? European Commission has a big project called the International project and in this project 35 partners work together. They are bound by a contract and have specific deliverables deadlines. Some of them work together and others work together in specific areas. Everybody, each year or twice a year gets exposed to the consortium and gets to know what is happening in the consortium. This brings them together and they can network with each others. Has there been a decline or increase in the number of TB cases globally? The TB Report is always two years late, so the report released in 2009 deals with cases of 2007 and the one coming in 2010 will be based on 2008 results. In 2007, there has been a slight decline of one percent in the number of new instances globally. This is very important because this might be a turning point because there has been an increase of 10 percent in the last 10 years. However, we need to wait and watch how much the infections decrease. A lot of countries have adopted Directly Observed Treatment, Short Course (DOTS) strategy and they are treating positive cases. The partnership aims to detect 70 percent of these cases, treat 85 percent of them and we reach that target. — Sanjeev Jain in Bangalore ]]> <![CDATA[Biofuel policy gets legislative nod]]> https://biospectrumindia.com/news/95/1535/biofuel-policy-gets-legislative-nod.html https://biospectrumindia.com/news/95/1535/biofuel-policy-gets-legislative-nod.html Thu, 04 Feb 2010 17:07:00 +0530 After much wrangling between vested interests, India has finally negotiated a national biofuel policy. An industry perspective... The growth of biofuels around the globe is spurred largely by energy security and environmental concerns. A wide range of market mechanisms, incentives and subsidies have been put in place by several countries to facilitate biofuel’s growth. Developing countries also view biofuels as a potential means to stimulate rural development and create employment opportunities. The Indian approach to biofuels is somewhat different from the current international approaches, which could lead to conflict with food security. Indian approach is solely based on non-food feed stocks to be raised on degraded or wastelands that are not suitable for agriculture, thus avoiding a possible conflict of fuel versus food security. In the context of the international perspectives and national imperatives, the Ministry of New and Renewable Energy (MNRE) has announced the National Policy on Biofuels on December 23, 2009. The policy, approved by the cabinet envisages development of the next generation of more efficient biofuel conversion technologies based on new feed stocks. It sets out the vision, medium term goals, strategy and approach to biofuel development, and proposes a framework of technological, financial and institutional interventions and enabling mechanisms. The goal of the policy is to ensure that a minimum level of biofuels become readily available in the market to meet the demand at any given time. An indicative target of 20 percent blending of biofuels, both for bio-diesel and bio-ethanol, by 2017 is proposed. Blending levels prescribed in regard to bio-diesel are intended to be recommendatory in the near term. The policy document focuses on multi-sphere development both at the national and state level by promoting the biofuel plantation and processing. Business houses and corporates shall find the policy favorable in most of the aspects and the industry as such shall face a positive transformation by having a clear policy in hand to operate. CS Jadhav, director — marketing, Nandan Biomatrix, Hyderabad, says,“One vital aspect is that the policy document addresses all the issues across the entire value chain from feed stock research to marketing of the end fuel. Broadly, the indicative targets of 20 percent blending, community development through energy plantations, incentivizing the operations across the value chain, and regulating the marketing and distribution of the biofuels, offer a level playing field for all the stakeholders involved.” Analyzing the policy component wise, a major thrust is given through this policy to innovation, research and development, and demonstration in the field of biofuels. R&D will focus on plantations, biofuel processing and production technologies, also on maximizing efficiencies of different end-use applications and utilization of by-products. High priority will be accorded to indigenous R&D and technology development based on local feed stocks and needs, which would be benchmarked with international efforts and patents would be registered, wherever possible. Securing quality feed stock in right quantities is the biggest challenge for the bio-diesel processors in India. The policy encourages contract farming in the degraded/forest/non-forest lands involving farmers/landless laborers. Also, the most encouraging clause is that the employment wages in jatropha plantations are linked to the NREGP. Financing of biofuel plantation and processing being categorized as priority sector by the financial institutions and banks is again a positive section. Import-export regulations in the policy protect the interests of the domestic players by putting appropriate checks on the imports of bio-diesel. These shall trigger huge growth in the domestic plantation development and processing since the import of free fatty acids for bio-diesel production is not allowed. With a huge capital outlay and uncertainties on the pricing of the end product, the industry is less operational and also the new entrants do not find the segment lucrative. Infrastructure development facilitation across the entire value chain, encouraging innovative and cost-effective technologies, 100 percent foreign equity in the real assets of technologies and projects, and tax sops for import of required processing machinery shall boost the industry by attracting new entrepreneurs. Moreover, MPP of bio-diesel is linked to the retail price of the diesel and the price fluctuations do not have any bearing on the processors and is compensated by the government to the OMC. Such policy initiatives make the projects financially more viable and overall industry shall be foreseen to be well-established and healthy. According to CS Bhaskar, MD, Naturol Bioenergy, Hyderabad, the pricing benchmark proposed by the government is appropriate and anything more than that would not be possible. However, he notes that the policy still lacks clarity on percentage blend for bio-diesel. He shares, “In the long-term, the biggest challenge for this industry may be the ability of the feed stock supply to keep up with growing demand.  The supply of soybeans, rapeseeds and other feed stocks available for bio-diesel production will be limited by competition from other uses and land constraints.” He suggests that the key to the future of biodiesel is finding inexpensive feed stocks that can be imported from other countries. And once the domestic market gets stabilized, government can look at putting cap on imports. Overall, the policy has kept the bars low for the industrialists and corporate houses, thus widening the scope and promoting biofuel projects in the country. Though the policy has given a direction to the industrialists, there are few concern areas still to be addressed by the policy makers and the committees constituted. Clarity on the MSP of jatropha seeds and also the MPP of bio-diesel shall assist the players in planning their projects, assessing financial feasibility and ultimately to commercialize the industry as such. Biofuel policy at a glance Positive shots: Corporates are encouraged to take up contract farming through minimum support price (MSP) mechanism Plantations are encouraged in government/community wasteland, degraded or fallow land in forest and non-forest areas – gives clarity on forest lands being used for bio-diesel plantations Employment provided in the plantations will be made eligible for coverage under the National Rural Employment Guarantee Program (NREGP) The minimum purchase price (MPP) for bio-diesel by the pil marketing companies(OMCs) will be linked to the prevailing retail diesel price. In the event of diesel or petrol price falling below the MPP for bio-diesel and bio-ethanol, OMCs will be duly compensated by the government - MPP is linked to MRP of the diesel, this would be the top line figures purely based on production. Market price fluctuations do not affect bio-diesel producers at all Plantations and also the entire processing infrastructure are financed under priority sector for the purposes of lending by financial institutions and banks. Hence it is easy to source funds Thrust on R&D and innovative second generation technologies by promoting demo projects through public-private partnership (PPP) The 100 percent FDI in technologies and projects, provided the fuel is for domestic use – Since the companies do not have much choice on export, this statement shall be taken as 100 percent FDI being allowed Protection of interests of domestic players by putting checks on import of biofuels and banning the import of free fatty acid (FFA) for production of bio-diesel Critical shots: Analyzing the techno-economic viability of 400 species of tree bearing oilseeds (TBOs), production and distribution of plantlets by nurseries of certified institutions/ organizations identified by the state governments – Does this mean that companies approach the state governments and get their NPCs certified/ recognized? — debatable The responsibility of storage, distribution and marketing of biofuels would rest with OMCs — No other option other than to sell biofuels to OMCs Export of bio-diesel is not allowed until the domestic blending requirements are fulfilled — India can lose out on the huge demand in European Countries? If crude jatropha oil (CJO) is exempted from the definition of biofuels, it will benefit the industry Not so clear shots: Lack of clarity in the very definition of biofuels — whether CJO is a part or not MSP will be decided in due course of time SMP mechanism similar to sugarcane shall also be considered — Current statutory minimum price (SMP) mechanism and the state advised price (SAP) for a commercial crop like sugarcane works in India since the processors /mill owners have their profits based on byproducts and their processing units like distilleries If the same pricing formula is adopted by the steering committee for biofuels, should the processors focus on marketing of byproducts/go for downstream processing? One more catch is that the policy does not make a mention on the marketing of the seed cake/glycerin MPP linked to retail price of diesel — is it linked directly? Are there any other factors considered? If the retail price of diesel becomes lesser than the per liter cost of production of bio-diesel, will the processor be compensated? Why the normal/basic cost plus pricing was not considered? ]]> <![CDATA[India's R&D-The Future Forward]]> https://biospectrumindia.com/news/95/5829/indias-rd-the-future-forward.html https://biospectrumindia.com/news/95/5829/indias-rd-the-future-forward.html Thu, 04 Feb 2010 16:37:00 +0530 India has what it takes to become an R&D hub in the coming decade. We just need to tackle the roadblocks India is fast emerging as the preferred R&D destination for many companies across the globe, outpacing cut-throat rival, China. Faced with increasing drug development costs and commercialization on one hand and drying pipeline on the other, global companies have now chalked out elaborate plans for India not just because of the low costs it has to offer but due to faster and cheaper time-to-market opportunities, a larger and diverse patient pool and the availability of a sizable number of scientists. It has been estimated that the cost to conduct a trial in India is 50 percent lower than that of a developed market. Indian companies have realized this and are making massive R&D investments. Results of a recent survey demonstrated that R&D spending by India's 25 leading drug makers grew nearly 17 percent in 2008-2009, with a number of firms increasing their investments by over 40 percent. The total spending on R&D was Rs 321 crore, according to a news agency. However, India still has a lot to do. Its spending on life sciences R&D is paltry 0.9 percent of its GDP which is extremely low compared to nations like China or Brazil. In US this figure is 2.5 percent of the GDP. A recent McKinsey report says that India can aspire to become an innovation hub by 2020. But this requires globally competitive research infrastructure, world-class talent, funding, private-public partnerships and enabling regulatory environment. To be the next R&D hotspot, India has to devise a strategy of promoting its R&D agenda. Essentially, change from the roots is required. Education system is a good place to begin. We need scientists and researchers who can think out-of-the-box and can in turn drive innovation. Moreover with drug development and commercialization costs sky rocketing, the industry should look at approaches that drive down R&D costs. In the ensuing pages, BioSpectrum team has put together highlights of the key points that have emerged in discussions with the R&D heads across life sciences companies. Strategies to clear some of these roadblocks and drive the country's innovation agenda with efficient R&D will be deliberated at the BioSpectrum Technology Forum 2010 in Goa on February 16 & 17, 2010. The forum is by invitation only. If you are an R&D head and want to participate you can register for invitation at: http://events.biospectrumindia.com/TechnologyForum2010/ A time to step up R&D Innovation will be the key, if India needs to match up with global standards in R&D Unfortunately, Indian scientists and researchers are more 'development-driven' rather than 'innovation-driven'. â€œThe system in India is such that it kills novelty. India has established itself in the world with generic versions of innovator chemical drugs and is looking at biosimilars in a big way. But then to be a global name you need to be an innovator. We need to create an environment of early innovation,â€? says Dr MK Sahib, director, Genomics and Biotechnology Research, Wockhardt. This boils down to the education system of the country, which till date has been churning out a vast number of graduates but not skilled talent. Attribute this to the fact that the system propagates a syllabus that is more theoretical than practical. â€œStudents here should be trained to be different, challenge the old order and that is when innovation can come about. We should be open to new avenues and also permit people to be different. It is already taking place,â€? adds Dr Sahib. Says Dr Ramani Aiyer, senior vice president, strategic development, Actis Biologics and former CSO, Actis Biologics India, â€œWe must make science more exciting to them. Churn out PhDs and young scientists. A lot of Indians go to the US not for the money but for the scientific problems offered there, essentially challenges.â€? There is a paradigm shift in the dynamics of the industry from blockbuster drugs to customized medicines. This is when improving the infrastructure of the country comes into the picture. â€œWe have a huge manpower base in India but then the Government needs to increase investments in quality infrastructure,â€? says Dr Sahib. Compared to investments in pure pharmaceuticals, R&D in biotech requires a high-end infrastructure, which automatically means mammoth investments. â€œCosts of developing a chemical drug is low which also results in lower returns but for a biologic drug, the costs might be higher, but companies and the government should realize that the returns will be equally higher,â€? says Dr Sahib. Dr Aiyer believes to the contrary and mentions, â€œThe government has put in their best to promote India R&D. It is the Venture Capitalists (VCs) and Private Equity (PE) players who should take a more risk driven approach to the industry.â€? Dr Dhananjay Patankar, chief operating officer, Intas Biopharmaceuticals agrees with Dr Aiyer. â€œ The DBT is exploring avenues to fund research, focus on the opportunity of bio-similar products and create infrastructure to scale-up human resources to support a shift to high-end research in the long term. The Center is also looking to support innovation from universities and a Bill to empower scientists and help them commercialize their innovations is expected to be passed by the end of the year.â€? The industry also claims that the IP regime needs to be reviewed and the regulatory framework pertaining to pre-clinical and clinical trials needs to be harmonized. â€œI want the government to ensure that patents are enforced properly, which can be beneficial both to the MNCs and Indian companies. There are aspects like data exclusivity and incremental innovation, which needs to be more clear in their definition. Evergreening should also be looked at as a serious issue,â€? adds Dr Aiyer. The future ahead After its success with Information Technology and Telecom, life sciences is the next big growth story in India, as the market is looking attractive for offshoring and outsourcing. Contract Research and Manufacturing Services (CRAMS) also seem to be big on growth. â€œThe global clinical research outsourcing market is projected to touch $23 billion by 2011, with market research companies estimating that India will corner 15 percent of this in two years,â€? adds Dr Patankar.It has been estimated that by leveraging its capabilities, India has the capability to touch almost $8-10 billion by 2020 from R&D alone. Dr Aiyer is optimistic, â€œFive years down the line I am confident that India will come out with at least one NCE and the number can also go up to three. A number of molecules in India are already reaching phase-III. If we come out with an New Chemical Entity (NCE) it will be a great milestone in the western markets. We are on the threshold of this one,â€? he says. Ways to enhance R&D While R&D retains its position as a key driver in the success of India's life sciences industry, there emerges a strong need for research collaborations both within the industry and with the Government institutes in the form of public-private partnerships (PPPs). Significant research can also come about with collaboration between the industry and the academic institutions. In order to provide an impetus to PPPs, the Indian Government has directed considerable efforts especially to promote flow of core scientific knowledge from the national laboratories and institutes of higher learning to the industry for further development and commercialization. Companies too have taken the step forward in revamping their R&D team structures to make it compatible with the overall demands and needs of the industry. Public-private partnerships The Union government has been supporting start up firms with seed funding through the New Millennium Indian Technology Leadership Initiative (NMITLI) and Special Drug Development Research Initiatives. Six biotech parks are functioning in various states under the public-private partnership and 10 parks are in different stages of development across the country. Several world-class scientific institutions like the National Center for Biological Sciences (NCBS), the Indian Institute of Science (IISc), and the Center for Cellular and Molecular Biology (CCMB) further lend support to the sector. The Council of Scientific and Industrial Research (CSIR) led institutes such as National Chemical Laboratory (NCL), Pune, Center for Drug Research Institute (CDRI), Lucknow and IMTECH, Chandigarh have been the vanguard of the public private partnerships. IMTECH has collaborated with about 32 companies including Ranbaxy, Cadila Pharmaceuticals, Lupin Labs and Panacea Biotech for contract research projects. Recently, CDRI, Lucknow entered into a contract research collaboration with Biocon â€œThere are many successful stories related to drug development in CDRI with pharma industries in private and public sectors. Out of 16 new drugs/products developed in India, CDRI alone has shares of 11, which shows the important role of CDRI in pharmaceutical sector,â€? says Dr Rajendra Prasad, head and deputy director, business management, CDRI, Lucknow. The sharing of ideas and facilitating the technology transfer along with the technical expertise forms an important part of PPPs in R&D. PPP remains one of the important needs of current times and there is a need for the industry to come forward and recognize the potential of Indian scientists and their capabilities in R&D,â€? says Dr Rajesh Gokhale, director, IGIB. Similarly, the DBT's National Biotechnology Development Strategy involving schemes like SIBRI, BIPP and especially the BIRAP to promote the R&D in biotech industry, has been one of the motivating factor for many SMEs. DBT-funded institutes such as NCCS, Pune, NII, New Delhi and CDFD, Hyderabad have also made some concrete efforts in this direction. One such example is the DBT-funded project on developing HRP-II/ p-LDH based diagnostic kits for the differential detection of malarial parasites by Bangalore-based Bhat Bio-Tech in collaboration with National Institute of Malaria Research, New Delhi. In agribiotech sector too, there are many examples of collaboration such as Mahyco with University of Agricultural Sciences, for Bt brinjal and SIBRI funded project on the stress resistance strategies in maize (Zea mays) by Nuziveedu Seeds Hyderabad in collaboration with ICGEB, New Delhi. The HUGO opens personalized medicine pathway As the genome initiatives got under way, the need for an international coordinating body was felt by the scientists-That is how the Human Genome Organization (HUGO) was conceived in April 1988, by Sydney Brenner at the first meeting on genome mapping and sequencing at Cold Spring Harbor, US. Victor Mckusic was its first president. HUGO was established to foster collaboration between genome scientists around the world. What began in 1990 as a 15 year, $3 billion international scientific project has advanced faster than was ever imagined. Ever since the mapping of the human genes under the first Human Genome Project completed in 2003, genomic discoveries are pointing the way to new drugs and tests that disrupt processes at the molecular level and that predict one's risk for a disease. Based out of Geneva, Switzerland, HUGO has members drawn from 23 countries and has been at the forefront of efforts to coordinate the mapping of the genome across the world. The HUGO's Pan-Asian initiative is a consortium of 90 geneticists and 40 institutions from 10 Asian nations, namely China, India, Indonesia, Japan, Malaysia, Philippines, Singapore, South Korea, Taiwan and Thailand. It collected samples from 1,928 unrelated individuals representing 73 groups of people from 10 countries and 10 linguistic lineages from member countries as well as from two non-Asian population groups of Africo-American and Caucasian ancestry. According to the study, modern humans evolved in Africa and spread across the world, adapting locally to the selective pressures of climate, food sources and pathogens. In India, the first Human Genome Meeting was held in Hyderabad in September 2008. Now the recent completion of first ever human genome sequencing as a part of HUGO project in India by scientists at IGIB, Delhi, is being closely seen as a step towards personalized medicine. These developments, especially in India, have raised hopes for new drugs for diabetes and heart diseases developed with the help of new genetic information. Pharma and biotech, agriculture, and forensics are just some of the few areas that have been improved by the discoveries made. Leadership strategies in R&D Innovation in life sciences is not for the faint-hearted R&D organizations are now striving for greater empowerment and less hierarchy. The role of an R&D leader is witnessing a paradigm shift towards an entrepreneurial drive and competitive spirit. Senior R&D leaders today, are expected to play a greater external role, representing the company within the public and the industry by positioning the company as an attractive partner in open innovation. There is widespread agreement among HR experts that R&D leaders need to improve their leadership competencies, specifically their drive for entrepreneurship and competition, ability to create vision and set strategy, and competency in executing for results. The makings of a leader â€œInnovation cannot be taught and it requires many enabling attributes to provide the right â€œecosystemâ€?. Other than requisite infrastructure and scientific tools, it requires research drivers (â€œdrug huntersâ€?) who have independent decision making authority, close communication between interdisciplinary scientific/commercial teams, access to domain knowledge (best obtained through collaborations) and an organizational structure which is lean, challenging and highly incentivized for success. Innovation in life sciences requires high investment, patience and is certainly not for the faint-hearted,â€? says Swapan Bhattacharya, managing director, TCG Lifesciences. Elaborates Dr Sami Guzder, R&D head, Avesthagen, â€œCritical thinking, and innovative approaches in problem solving seem to be lacking among the research groups. Trained, experienced personnel impact project completion that translates to increased efficiency and lower overhead. R&D leaders need to be able to recognize the right projects, people and collaborative models that will lead to the right decisions.â€? He suggests that the Indian biotech companies should streamline processes for increased efficiencies, should ideate innovative approach to problem solving and promote co-development (Public and /or Private) as a business model to reduce costs and enhance R&D efficiency. The other main focus is on improving the decision-making process in R&D. Although most are skeptical about the possibility of shortening late-stage clinical development, companies are now looking for ways to optimize the decision making in discovery research and preclinical and clinical development so that better and faster decisions can be made. â€œFaster and better-quality decision making will be gained through empowering people lower in the hierarchy, those who hold the most current scientific expertise and by bringing them together in multidisciplinary teams, says Dr Ganesh Sambasivam, co-founder and CSO of Anthem Biosciences. Team consolidations have become an extremely popular method of improving R&D efficiency by optimizing the structure and objectives of working groups. Many companies have undertaken substantial reorganizations throughout 2008 and 2009. Dr Ganesh Sambasivam feels the life science industry needs people from diverse backgrounds and different skill sets. Different functional teams should come together and this will lead to cross pollination of ideas. He urges that the 'out of the box thinking' is very crucial for increasing R&D efficiency. Companies and their Initiatives Companies that acknowledge the need for change recognize the value of their internal talent and put in place a fast and effective grooming process. They are also now waking up to the reality that they must set up strategy to attract international talent to fill in the talent gap that is persisting in the industry which also means that attracting expatriate talent is important if the region is to keep up the pace with the leading clusters and companies in the global life science industry. Says Dr Ganesh, â€œWhile India's educational system does not support an edge on technology and strength in drug discovery, the returnees from US and EU bring good skill-set in technology. For large companies, an integrated and proactive HR function is critical, together with a mindset whereby HR leaders work with line managers to take ownership for identifying and growing the right kind of talent. Woes of indigenous R&D The pressure to reduce R&D development time and cost is on With the current cost of drug development at $1.3 billion, the pressure is on to reduce R&D development time and cost without sacrificing clinical success rate. Drug development times, especially the clinical phase, have almost tripled in the last four decades, pushing up development costs sky high. Added to it is the fact that the number of new drugs have not significantly increased despite investment on technology by several pharmaceutical and biotechnology companies. In recent years, drug developers have been under significant pressure to introduce new products while confronting escalating R&D costs, blockbuster patent expiration and heightened regulatory scrutiny. According to Dr Suresh Menon, CSO, Novartis, â€œThe average drug development time is 10-15 years, clinical trials take half of this time and involves 60 percent of the total cost. To reduce drug development costs by Rs 200 crore, drug developers must reduce the time taken to develop the drug by 20 percent. And in order to save Rs 200 crore, developers would expect a clinical success rate reduction of 20-25 percent, a massive drop considering the success rates are relatively low even with a generous budget.â€? Making R&D affordable Although â€œAffordable R&Dâ€? has not traditionally been a concern for biotech and pharma R&D departments, the current economic climate has brought expense reduction programs into research labs. Most leading drug makers have recently undertaken or are in the process of implementing broad cost reduction programs. â€œMaintaining a high level of productivity is critical for drug makers to successfully continue introducing new products. Many affordable R&D programs fail because they reduce current expenditure at the expense of future drug development. Therefore, broad cost initiatives are required to maintain sustainability,â€? Dr Sami Guzder, R&D head, Avesthagen says, â€œAn important factor influencing R&D cost is the adoption of right technology and science.â€? Dr Jitendra Kumar, VP, Technology Incubation Center, IKP Knowledge Park, says â€œTechnology Business Incubators's (TBI) should be able to effectively connect start-ups with relevant R&D institutions and established companies to help them achieve synergies within such partnership. Also, TBI's should be able to catalyze product development and spin-offs from national laboratories by providing business mentorship to teams built around technologies developed, effectively reducing cost and enhance value of the R&D.â€? Aditya Burman, managing director, OncQuest Laboratories says, â€œEfficiency is more important than affordability. Basic collaboration is an essential element in research. In fact, the government has been encouraging it for a while. The political landscape of Indian academia and industry, combined with the fight for grant money, has always fostered competition far more than collaboration. Our scientists hold a lot of good work within themselves. A lot of collaboration is also needed among larger and smaller life science companies.â€? Dr Ganesh Sambasivam, co-founder and CSO Anthem BioSciences says, â€œThe outsourcing model has become very popular in recent years especially in India and China. India has 75-80 CROs and in China the number is double. For a big company, outsourcing R&D to India brings down their drug development cost by one third.â€? Drug development alliances are also increasingly being used to leverage resources and cut R&D costs. Drug development deal values are expected to triple over the next few years as developers seek partners to reduce in-house spending. IP for effective R&D Clarity in definitions is the starting point In the decade to come it will be innovation alone, which will determine a company's competitive advantage over its rivals, its monetary returns and revenues, its bargaining power and further incentives in research for its scientists. Having a powerful tool in the form of an efficient IP management strategy and synchronizing it with the DNA of an organization is a pre-requisite to innovation. Says a well-renowned IP expert, Shamnad Basheer, â€œThere is no dearth of innovative mind in India. Unfortunately company cultures do not foster an environment to bring that idea to fruition.â€? Barring top MNC companies, Indian companies are new to the IP game plan. â€œHaving a strong IP culture, integrating it in the overall strategy will mean that each and every person involved has the incentive to innovate and invent,â€? adds Basheer. Effective management of IP In many cases, the root problem lies in the fact, that scientists are not recognized for their inventions. Says Dr Milind Antani, head, Pharma, Life Science and Healthcare Practice at Nishith Desai Associates, â€œUsually the ownership rights of the invention by a research scientist employed remain with the company and not the individual. Companies need to recognize the individual invention of its scientists in some form. Recognizing such efforts would motivate and encourage scientists to look for innovations.â€? However, this comes about when only when the company has a strong IP management system in place. â€œOnce you start giving emphasis on IP and its role in strategy planning you are adding value to your discovery, recognize key markets for your products and also catch-up with potential competitors,â€? adds Basheer. Against this picture, awareness becomes key factor. Says Dr Alka Mehta, IP expert from the Intellectual Property Cell at Cipla, â€œTraining the R&D personnel to understand the patents and its importance in strategy planning for development, frequent discussions with the R&D team to update the IP situation on the products under development, exchange of ideas among R&D, medical, marketing and IP department for new technology and its demand in current and future business prospects and frequent discussions among various departments which are key decision makers for the business is important.â€? A company needs to be aware of not just their patents but trademarks, copyrights, internal processes, manuals, various technologies and trade secrets as well. â€œEffective portfolio management of IP enhances the competitiveness, assists in becoming a market leader and improves the economic performance,â€? adds Dr Antani. An emerging trend in IP management is patent landscaping which tells a company its next step in R&D. Patent landscaping helps in identifying and analyzing its patent portfolio pertaining to a technology area critical to the business needs. Once a company has a strong IP in place, its valuation increases. This becomes significant when it comes to commercialization of that IP especially when it comes to licensing, brand acquisition or a company acquisition altogether. Efficient integration of IP will also help a company form a clearer picture of the patentability of its product, the possible infringement situations and most importantly the cost factor involved. â€œAll the teams including the IP team need to sit down together right from the start and evaluate the risk and infringement factors and the strategy to adopt in case of an infringement,â€?claims Dr Kausalya Santhanam, founder-SciVista IP & Comm. It is only then that they can evaluate whether to maintain its IP in certain geographies across the world, whether to allocate or withdraw money for a stipulated number of years. Efficacy of India's IP regime With effect from January 1, 2005, India switched from a process patent regime to a product patent regime by which only the product and not the manufacturing process of the product would be patented. Once this was in place, the country saw a surge in research work and clinical trials, a churning out of quality scientists and researchers and most importantly, many MNCs who had shut shop during the process patent regime came back to India and geared up to launch their patented drugs in the market. This resulted in India becoming a prime destination for drug discovery opportunities. â€œMore incentive and business opportunities for Indian companies with R&D base is now available,â€? adds Dr Mehta. However, there are certain hiccups in the IP regime. Basheer puts in a valid point, â€œI think the system is too complex and needs to be simplified. The patent system should be such that it allows a wider participation of scientists and the common man. Even a layman should be able to evaluate the patentability of his invention,â€? he mentions. â€œThe system is yet in development phase so it would take some years to give fruits. The NCE policy is yet to be decided plus the Patent Database is not yet created to its fullest extent,â€? agrees Dr Mehta. ]]> <![CDATA[The curious case of Bt brinjal]]> https://biospectrumindia.com/news/95/1787/the-curious-case-of-bt-brinjal.html https://biospectrumindia.com/news/95/1787/the-curious-case-of-bt-brinjal.html Thu, 04 Feb 2010 13:00:00 +0530 The New Year has not started well at least for the BioAgri industry. Prime Minister Dr Manmohan Singh set the ball rolling with his comments calling for a cautious approach to the approval process for genetically modified (GM) food products, even as he highlighted the Bt cotton success story. He made these remarks while inaugurating the 97th Indian Science Congress session, the annual gathering of scientists, at Thiruvanathapuram on January 3.  “The technology of genetic modification is also being extended to food crops though this raises legitimate questions of safety. These must be given full weightage, with appropriate regulatory control based on strictly scientific criteria,” remarked the PM. And this remark has in fact set in motion a chain of events that may eventually lead to an unexpected decision on Bt brinjal. An open and shut case of regulatory approval for the first GM food product in the country has got caught in a major political and public controversy. The regulatory agency, the Genetic Engineering Approval Committee (GEAC) in the Ministry of Environment and Forests (MoEF) is the final authority to approve the introduction of a GM food crop in the country. The government has not taken any anti-GM policy decision so far. GEAC is empowered by law to clear commercial use of any GM product. All pharma products, approved by GEAC, go to the Drug Controller General of India for final decision. In the case of agricultural products, GEAC’s decision is final. Usually, after the minutes of a meeting is approved, the decision is conveyed to the applicant about the approval or rejection of a transgenic event. In this case, GEAC had approved the transgenic event used by Bt brinjal by Mahyco on October 14, 2009. However, the Environment Minister Jairam Ramesh has taken upon himself the role of a “super regulator” to have the final say on the Bt brinjal approval. In fact, Ramesh has publicly stated that he will gather public opinion on Bt brinjal through a nationwide consultation process and present the views with his inputs to the Prime Minister in February for the final call. This is indeed a very curious regulatory process. Usually regulators are empowered with legal and technical inputs to take the final call. Here the anti-GM activists have been able to drum up support against the October 14 decision of GEAC based on two points: One, GEAC is not a representative organization and hence anti-GM views should be heard. Two, a transgenic food crop such as brinjal is different from GM pharma products and hence wider consultations are required. It is the “unrepresentative” composition of GEAC that has given both the minister and anti-GM activists the leeway to enlarge the scope of the Bt brinjal approval process. The GEAC is made up of 31 members. Of them, 10 are bureaucrats and 19 are scientists —both serving and retired ones, drawn from various government-funded laboratories. There is one legal expert and the last one is an economist. So, there is definitely a case to rework GEAC’s composition to make it more representative especially since it is going to decide the approval of a dozen more GM food products in the near future. The proposed government plan to introduce a new regulatory system for biotech has more or less been consigned to the freezer. More consumer representatives and eminent scientists not linked to either the government or industry should be inducted into the regulatory agency. Based on the inputs gathered during the public consultative process, it will be difficult for the government to approve commercial cultivation of Bt brinjal in the near future. Stung by the midnight December decision on the creation of Telengana issue, Manmohan Singh government is most likely to play it safe and put the Bt brinjal approval process in the freezer for a few more years. If this happens, the interim period should be used to set up credible, independent testing systems for all GM products so that the regulator’s words will carry conviction with citizens, at least the next time around. Group Editor sureshn@cybermedia.co.in ]]> <![CDATA[Why ain't biotech IPOs happening in India?]]> https://biospectrumindia.com/news/95/2755/why-aint-biotech-ipos-happening-in-india.html https://biospectrumindia.com/news/95/2755/why-aint-biotech-ipos-happening-in-india.html Fri, 15 Jan 2010 11:10:00 +0530 Why ain’t biotech IPOs happening in India? Companies use IPOs to raise money for expansion and growth. That was the story until the beginning of 2008 when globally, the markets were red hot. All that changed when the credit crunch set in, taking along with it the interest in IPOs. Five summers ago, Biocon, one of the most keenly watched life sciences company in India then, went public. Its shares were oversubscribed and the company received overwhelming response from the investors. When the company listed on Indian bourses, it made Dr Kiran Mazumdar-Shaw, founder of Biocon, a billionaire and for the first time an Indian women became a dollar billionaire. Between then and now, biotech IPOs in India have been almost nil. Experts attribute this to the small size of Indian biotech companies and low awareness amongst investors about companies. IPOs in biotechnology started in the US when the stock regulator allowed Amgen and Cetus to raise money from the public in the early 1980s. Today the US has the largest number of publicly traded biotech firms while in Asia, with the exception of Australian companies, there are few success stories. In others Asian countries, there are only a handful of biotech companies whose shares are traded. Companies use IPOs to raise money for expansion and growth. That was the story until the beginning of 2008 when globally, the markets were red hot. All that changed when the credit crunch set in, taking along with it the interest in IPOs. Wockhardt, one of India’s top tier pharma company and hospitals chains too aborted its plans to list to raise money to clear its debts after a bad market dampened its interests. The company later sold its 10 hospitals chain to Fortis Hospitals, owned by the family that previously owned Ranbaxy, India’s top pharma company by revenues, for Rs 909 crore. Analysts tracking the biotechnology companies believe that the investors in India are “more cautious,” to invest especially in biotech firms as it is better and easier to invest after observing the proof of concept of the company, its clinical development and launch of the product. But that might change now. Avesthagen, a Bangalore-based biotechnology company, with an interesting pipeline of products, is planning to hit the stock market in March 2010. The company, promoted by Villoo Morawala-Patell, aborted its IPO plans twice in 2008 and once in 2009. Sujay Shetty, the Mumbai-based associate director, Pharma Life Sciences Advisory, Pricewaterhouse Coopers (PwC) feels that last year’s global meltdown coupled with financial turmoil in the country weren’t conducive enough for the new IPOs to emerge. “Money has been declining and investors are getting burnt. In the US, the liquid market is well-established and the eco-system is much developed, but in Europe and Asia, the eco-system is different.” Further, he adds that it is difficult to churn out money in biotech companies. In fact, the R&D is uncertain in the life sciences sector, due to which the investors shy away from the industry. The biotechnology industry on the whole has been severely impacted as new investments are not coming in and valuations of the companies have also plummeted. In such a gloomy scenario, earlier forecasts of the Indian biotech industry becoming a $5 billion market and employing one million people will be a challenge and difficult to meet. Experts view that most of the regional biotech companies at present have a business model based on private funding due to the long gestation period, due to which investors shied away from this industry. “Biotech companies are high risk, complex businesses. There are hardly any benchmark for valuation because most of these have no balance sheet and cash flow. US is a matured market and hence it works over there but not here,” says Jigar Shah, investment advisor, KR Choksey Securities, Mumbai. John Powath, CEO, Inventive Business Partners, a Bangalore-based company, believes that biotech companies are no stranger to risk. The business of developing drugs is a high risk (and for those who succeed high reward) undertaking and that’s the reason biotech companies are not resorting to IPO. Powath who earlier worked as a partner in Ernst & Young, says that there is a lack of understanding of how this sector operators amongst most public investors. “Typically, the funding is required for R&D which may or may not be successful. Given this risk parameter, investors are likely to stay away. Funding using the IPO route for biotech companies make sense where there is one or two blockbuster development and funds are required for production and commercialization or have some sort of proven cash flow and revenues,” says Powath. “Most biotech companies’ revenues are typically small and hence are not attractive enough for listing — which is why we see strategic investor or VC funding as the preferred investment mode.” According to Murali Nair, partner,Advisory Services, Ernst & Young, typically, evolution of companies follow a path involving three stages. One, the basic idea is supported by limited capital from the promoter or the Venture Capitalist (VC), secondly once the business develops to a certain critical mass and can demonstrate a sustainable model and management, the next growth phase is funded by a PE or group of investors known to the promoters. And the third phase is when the company goes for larger funding for expanding a business that has already demonstrated a healthy top line, bottom line and sustainable cash flow, and the business model is understood by a larger community. IPO is a tool for funding at this stage. “The US biotech industry has evolved in a similar way along with government funding. However, in India, the crucial VC funding for early knowledge business has sadly been lacking. Hence, there are only a very few companies who today are in a stage to successfully conduct an IPO. In addition, a general lack of understanding of biotech business coupled with a perception of high risk has not helped the industry in its early scale up,” says Nair. Indian markets have always been highly sensitive towards cashflow and any business which needs significant investments with a high risk future cash flow potential does not lend itself well for IPO in India. Nair says, “Biotech is a victim of this syndrome and I would believe we need more of VC and private equity funding here than an IPO considering the stage of business that is prevailing in India.” Whether or not that happens,biotechnology companies are keen to raise money and will look up to Biocon or just about any other successful listing of a biotech company as a beginning of end to a bad patch in the market. Anjana Pradhan and Sanjeev Jain in Bangalore ]]> <![CDATA[Eisai expands India presence]]> https://biospectrumindia.com/news/95/6206/eisai-expands-india-presence.html https://biospectrumindia.com/news/95/6206/eisai-expands-india-presence.html Fri, 15 Jan 2010 11:03:00 +0530 Eisai expands India presence Eisai, a pharma major from Japan, has given a thrust to their India operations by setting up a manufacturing and process research base in India. The company has made a total investment of nearly Rs 232 crore ($50 million) on this 50-acre campus located at the Special Economic Zone (SEZ) at Jawaharlal Nehru Pharma City in Visakhapatnam, Andhra Pradesh. Unlike its Japanese counterparts, Eisai, a pharma major from Japan has set-up a facility in India rather than acquiring an Indian market leader. By setting up a manufacturing and process research base in the country, Eisai, has given a thrust to its India operations. The facility known as the Eisai Knowledge Center, is located at the SEZ at Jawaharlal Nehru Pharma City in Visakhapatnam, Andhra Pradesh. The company has made a total investment of about Rs 232 crore ($50 million) on this 50-acre campus. The facility, which is scheduled to start full-scale operations by September 2010, will be Eisai's first base to integrate active pharmaceutical ingredients (APIs), formulation manufacturing and API process research on one site. According to Sanjit Singh Lamba, president, Eisai Pharmatechnology and Manufacturing, India, this facility would emerge as the global hub for R&D, formulations and API manufacturing. The center is aimed at stimulating the knowledge creation between the researchers and the production team. Future global hub The Eisai Knowledge Center was built to create a future global hub capable of ensuring a stable supply of high quality pharmaceutical products and achieving innovation in API synthesis processes. With this facility, the company’s API production will be integrated with the Kashima plant, Eisai’s another manufacturing plant in Japan. The facility in Visakhapatnam employs over 100 people, including 20 research scientists. The company is planning to double it's manpower in a year's time. The formulation facility has a capacity to produce two billion tablets annually and the API section has an annual, capacity of 30 tonnes. This facility is the fourth knowledge-based center of Eisai worldwide. The other centers are located at Japan, UK and the US. This is the only API facility of Eisai outside Japan, which is meant for global pharmaceutical market. The company is expecting approval for this setup from various regulatory bodies by the end of 2010. “Initially, we would use the facility to manufacture two of our blockbuster products — Aricept and Myonal. We are also exploring the option of shifting four other products from the facility in Japan to the Indian facility,” says Deepak Naik, managing director, Eisai Pharmaceuticals, Mumbai. The Alzheimer's drug, Aricept, contributes nearly Rs 14,800 crore ($3.2 billion) to the total revenue of the company, globally. The drug will go off patent in 2012. According to Naik, the company would work on additional indications for Aricept to add value on it in order to take on competition from generic players. The company has plans to expand the existing facility to accommodate newer products and it will also build a new 50-acre facility by next quarter, but the location is yet to be decided. Brings global standards to India Headquartered in Tokyo, Eisai is a research-based human healthcare company that discovers, develops and markets pharmaceutical products throughout the world. Eisai focuses on three therapeutic areas: integrative neuroscience, oncology, and vascular/ immunological reaction. The company has production facilities in Japan, the UK, the US, China, Taiwan and Indonesia. Its R&D facilities are in Japan,the UK and the US, with over 10,000 employees worldwide. Eisai has a marketing presence in India since 2004 through its wholly-owned subsidiary, Eisai Pharmaceuticals in Mumbai. The company's pipeline is affluent with eight to 10 new chemical entities in different stages of development. The company also has six monoclonal antibodies in the pipeline, which is in phase II of development. The Eisai team in India will now become a part of the global development process, thereby, bringing Japanese quality standards to India. The company, which spends 19 percent of its revenues on research and development, would export 51 percent of its production from this facility located at Visakhapatnam to other countries. Eisai is shifting its focus to oncology and critical care, where there are several unmet medical needs. The last three major acquisition the company executed, throws light on this. In October 2006, it acquired four anti-cancer products from the US-based Ligand Pharmaceuticals, while in April 2007, it acquired US-based bioventure, Morphotek,that has proprietary human antibody technologies. The acquisition of another US firm, MGI Pharma, in January 2008 added key products such as Aloxi, an anti-emetic agent and Dacogen, a DNA hypomethylating agent to the company's pipeline. Ajeesh Anand in Visakhapatnam ]]> <![CDATA[BioSpectrum honors Indian biotech leaders]]> https://biospectrumindia.com/news/95/4537/biospectrum-honors-indian-biotech-leaders.html https://biospectrumindia.com/news/95/4537/biospectrum-honors-indian-biotech-leaders.html Fri, 15 Jan 2010 10:59:00 +0530 BioSpectrum honors Indian biotech leaders BioSpectrum Awardees were chosen by the 7th BioSpectrum Awards Jury headed by Prof. Samir K Brahmachari, director general, CSIR. BioSpectrum Awards now in its 7th edition, in 2009, recognizes exceptional performances by individuals and companies in this sector. Serum Institute of India and The Oxford College of Science, Bangalore, were the associate sponsors; and BD Biosciences and Pall Life Sciences were the support sponsors of the event. BioSpectrum Life Time Achievement Award Prof. D Balasubramanian LV Prasad Eye Institute Trained as a chemist, he became an eye researcher and today is an inspiration to thousands of biologists who look up to him not just for his leadership but also for his contribution in popularizing biochemical research. BioSpectrum honors Prof. D Balasubramanian with the Life Time Achievement Award—2009, for his significant fundamental contributions to translational biology through scientific discovery and body of work. BioPerson of 2009 Award Hari S Bhartia Jubilant Organosys Co-chairman and Managing Director of Jubilant Organosys, Hari Shankar Bhartia, has showcased how to leverage the India advantage and maintain the competitive edge. Under his active leadership, Jubilant Organosys is riding on the pharmaceutical and life sciences business, and is continuously evolving. BioSpectrum recognizes his pioneering vision in leading the company with the integrated business model offering, pursuing a fast clip of growth and its positive impact on the industry. BioEntrepreneur of 2009 Award Apurva Shah and Binoy Gardi Veeda Clinical Research Establishing a global presence across Europe, India, the US and South East Asia, through a succession of acquisitions, Veeda’s success story would not have been possible without the skillful leadership of this entrepreneurial duo, Apurva Shah and Binoy Gardi. BioSpectrum honors their effort in making Veeda a major player in the global CRO landscape with the BioSpectrum Entrepreneur of the Year Award 2009. BioProduct of 2009 Award Dry Tri-T STAT ReaMetrix ReaMetrix is the first company in the world to successfully pioneer an FDA cleared dried-down product to measure CD4 counts that needs no refrigeration. Dr Bala Manian’s ReaMetrix, started in Bangalore, has lived up to the founder’s visionary expectation. The jury decided to give the ‘BioSpectrum BioProduct of 2009’ to Dry Tri-T STAT, an HIV detection and management product for the masses. The world’s first US FDA approved product, available in a dry form, could replace the currently widely used liquid-based alternatives in HIV detection kits which make them dependent on expensive and complex cold chain network. The ReaMetrix product will drastically reduce the cost of HIV tests and increase the reach of technology to the people who need it most. Meeting of minds The winner of the BioSpectrum Life Time Achievement Award, Dr D Balasubramanian, has had tremendous influence on the Indian biotechnology sector. The acclaimed stem cell researcher from the Hyderabad-based LV Prasad Eye Institute enthralled the audience during a fireside chat session held in Bangalore. During the chat with the theme entitled 'Stem Cells and Personalized Medicine', he said, "The word biotechnology is hardly 50 years old. And I look at biotechnology at various stages, from molecules to genes." He has tremendous influence on the Indian biotechnology sector. Whether it was in laying the foundation for the growth of University of Hyderabad which today has one of the country’s finest life sciences school or in consolidating the success of Center for Cellular and Molecular Biology (CCMB) after taking over from Dr PM Bhargava or in playing the pivotal role in incubating India’s first pure play biotech company, Shantha Biotechnics, Dr Balasubramanian who is affectionaly known as Prof. Balu, gave the science of sight, a human face. By restoring the sight of over 700 people, the LV Prasad Eye Institute is setting another milestone in the annals of healthcare under his leadership. The other fireside chat with the theme 'The prospects for India's BioServices Sector', was interesting and enlightening too. Dr Kiran Mazumdar-Shaw, founder of Biocon and Narayanan Suresh, group editor of BioSpectrum, Hari Bhartia, the co-chairman and MD of Jubilant Organosys shared their thoughts on the Indian bioservices. Bhartia, who was awarded the BioSpectrum Person of the Year Award, stressed on the need of public private partnership (PPP) for new ideas to emerge. "Government has the money and will, but execution is required to tap young minds. And to attract them, capacity building is required." Dr Kiran Mazumdar-Shaw whose group company Syngene International shared BioServices Award with Jubilant Organosys said the key challenge in India is in terms of employable manpower. She said, “There are young and eager minds who are keen to contribute to India's growth. Emphasizing on the need to curtail the time period taken for taking a 'file from one desk to another', Dr Shaw said, "We still have lengthy procedures which retards and delays work. It's because of this that there are regulatory delays. There's a need to bridge the gap." The moderator for the fireside chat at the BioSpectrum Awards 2009 was Narayanan Suresh, the group editor of BioSpectrum. Company Awards BioSpectrum Company Awards recognize the contributions of companies in the biotech sector. These Awards are given to the top company in each of the biotech segments that BioSpectrum covers. And the Awards are decided on the basis of the India Industry Survey conducted by BioSpectrum-ABLE Top 20 Survey conducted in June-July every year BioPharma Company Award Serum Institute of India BioAgri Company Award Rasi Seeds BioIndustrial Company Award Novozymes South Asia BioServices Award Syngene International & Jubilant Organosys BioSuppliers Award Waters India Biotech School (Public) JNU Biotech School (Private) Sastra University BioSpectrum India Awards 2009: Jury The jury headed by Dr Samir Brahmachari, director general (DG) of CSIR, and BioSpectrum Person of the Year 2008, comprised: Dr Rajiv Bhat, professor and dean, School of Biotechnology, JNU; Narayanan Suresh, group editor, BioSpectrum; KV Venugopalan, president, Waters India; Dr Jasmin Patel, managing director, Fidelity International; Dr BV Ravikumar, CEO, XCyton Diagnostics; E Abraham Mathew, chief editor, BioSpectrum Next on Agenda BioSpectrum Asia Pacific Awards 2010 ceremony will be held in Singapore on March 12, 2010 ]]> <![CDATA['Purpose of BioSpin is to enter into new, emerging markets']]> https://biospectrumindia.com/news/95/2131/purpose-of-biospin-is-to-enter-into-new-emerging-markets.html https://biospectrumindia.com/news/95/2131/purpose-of-biospin-is-to-enter-into-new-emerging-markets.html Fri, 15 Jan 2010 10:42:00 +0530 “Purpose of BioSpin is to enter into new, emerging markets" —Harald Wolf, project manager of BioSpin for India The Biotechnology Sustainable Partnering India (BioSpin) was initiated in 2008 to create business relationships between German and Indian biotechnology as well as pharmaceutical companies, and to foster cooperations between research and business in India and Central Germany. This is one of the projects under the ‘India and Germany - Strategic Partners for Innovation’ initiative. With this initiative, the German Federal Ministry of Education and Research (BMBF) supports Indo- German cooperations. For the last one year, the German delegation has been screening the market in India and till date, has touched base with around 450 business and research delegates from India. On a recent trip to India, Harald Wolf, project manager of BioSpin for India, spoke exclusively to BioSpectrum. He shares more information about the BioSpin initiative, its goals and plans to accelerate the synergy between India and Germany. What are the key focus areas of BioSpin project? BioSpin was started in 2008. We decided to approach the Federal Ministry for Education and Research, because there were companies and research institutes in Germany that wanted to make business out of research projects in India. Partners in India mainly include Indian pharma and biotech companies. In Central Germany, there are three federal biostates - Saxony-Anhalt, Thuringia and Saxony - which alone encompass around 230 biotech companies, and 50 research institutes including university research institutes. It was then when we came on a delegation trip to India and we screened the potential Indian partners from the sector. After this, we began to contact companies in the domain of the life sciences industry because we had a strong focus on fine chemical specialties for the pharma industry and also on industrial biotech companies. The specialty of this initiative is that it is focused on biotechnology. This initiative is very important as far as Germany’s India initiative is concerned. Other initiatives which are funded by the federal government are more wider and comprehensive in their India focus. How is the biotech scenario in Germany, and how supportive is the federal government to companies and institutes? The year 1996 was a landmark year for biotech in Germany. We have young start-ups, bioclusters and concentration facilities. In Germany, there are around 450-500 biotech companies doing research in the avenues of enzymes production research, medical device and drug discovery services. We also have a lot of biotech concentrations and clusters all around the region. The federal government is extremely supportive to boost the biotech industry in Germany and as a result has introduced several initiatives. For example, you have the research project funding, education research funding, SME funding and funding for technology. The biotech initiatives undertaken also depends on the region. Germany is divided into 16 states and every state has its own funding system for biotechnology. There are different levels of funding, federal level, EU level and state level. For instance, for one state alone, there has been a funding of up to 150 million euros (about Rs 1,028 crore). This goes into infrastructure, incubators and biotech equipments for small and medium size companies. With respect to BioSpin, what prospects does India have to offer? India has the potential to offer two things for the BioSpin initiative. India gives us the opportunity to collaborate with the innumerable start-up companies and research institutes that have come up in the recent years. Start-up companies and established Indian companies are more open to collaborations because they know the prospects that the EU has to offer. The purpose of this project is to venture into new markets across the globe and to extend cooperation for research. Most importantly, we have observed that the academia here have the same spirit as in Germany. For instance, India has well-educated and learned academicians in biotechnology, research and pharma. What are the collaboration models you are planning to initiate with the Indian partners? It all depends on the company, their needs and their product. For instance, if they are into pure biotech or enzymes, the discovery might take place in Germany, after taking it to a certain phase, the production may be done in India. We did strike partnerships with Indian companies because for funding it becomes necessary to have an Indian partner. Apart from research, we also looked at marketing opportunities. We first tapped the fine chemicals sector and made our presence in India. What kind of funding is available for this initiative? This is a small initiative and focus on very niche market, so funding amount is very small. As of now, our funding is about 100,000 euros (about Rs 68.55 lakh). What are the joint activities you are taking with the Indian government? At the moment, there are direct talks with the German and Indian governments. This is in the event of a particular research institute under this initiative, along with undertaking business, research and production projects between two German and two Indian partners. So, when you have four partners you will get a 50 percent funding from Germany for the German companies, and the other funding comes from the ministry of technology for the Indian companies. You are planning to extend this initiative to Asia. Which are the countries you will be going to? Yes, we will be going to other Asian regions with India being the most important region. For example, we will be targeting China and Indonesia. Any similar delegation or initiatives in other countries beyond Asia? We went to Canada in 2005 and Great Britain in 2008. The US is not so important because we go there through the BIO international forums where we get all our possible partners, and you do not need a delegation. What are the future plans to take this initiative forward in India? In this initiative, we will also include bioinformatic companies. Our next step is to bring a delegation to India to bring about a nexus between bioinformatic companies and collaborate with research companies in India. So every time we make a delegation trip to India, we look into different sectors and segments in biotech and pharma. For example, this time it was industrial biotech and fine chemicals. The delegation trip for bioinformatics will be somewhere around February or March 2010. Nayantara Som in Mumbai ]]> <![CDATA[2010, Year of Collaboration]]> https://biospectrumindia.com/news/95/2832/2010-year-of-collaboration.html https://biospectrumindia.com/news/95/2832/2010-year-of-collaboration.html Fri, 15 Jan 2010 10:41:00 +0530 2010, Year of Collaboration 2009 was a ‘Year of Consolidation’ for the life sciences industry. The economic downturn has altered the way of conducting business. Increasing cost of conducting clinical trials, drop in the bottomline, patent expiry of blockbuster drugs and fall in the new product launches, will continue to haunt big pharmaceutical companies—but the outlook looks up. IMS Health observes that the value of the global pharmaceutical market in 2010 is expected to see a flat growth of 4—6 percent on a constant dollar basis, exceeding Rs.38.58 lakh crore ($825 billion), driven by stronger near-term growth in the US market. Commenting on the global pharma market, Murray Aitken, senior vice-president, Healthcare Insight, IMS Health, says, “Overall, market growth is expected to remain at historically low levels, but stronger-than-expected demand in the US is lifting both our short and longer-term forecasts. The economic climate will continue to be a dampening influence in most mature markets, particularly in countries with rising budget deficits and publicly-funded healthcare systems. In the US, pricing flexibility and inventory management actions are contributing to much higher growth than anticipated earlier this year, and are the main reasons for the upward adjustment to our five-year forecast.” The IMS Health noted that near-term growth prospects in the US have strengthened in recent months, reflecting both sustained levels of price increases and changing inventory stocking patterns. Pharmacy chains are more tightly managing their inventory levels based on expectations of patient demand, which has led to greater purchasing volatility than in the previous years. This also has played a role in unusually high sales growth in the first quarter of 2009, relative to forecast expectations. The US market growth in 2009 is now expected to be 4.5—5.5 percent, and 3—5 percent in 2010. While payers seek to limit price increases and boost the use of lower-cost generics, pharmaceutical manufacturers are expected to maintain their pricing practices, competing on the basis of clinical evidence and value. Growth has slowed in countries where there is high out-of-pocket spending on pharmaceuticals and steep declines in macro-economic activity, especially in Russia, Mexico and South Korea. At the same time, growth has been less affected to date in countries where drugs are largely funded publicly, such as in Germany, Japan and Spain. However, new cost-containment measures expected to be introduced during the forecast period likely will impact the pace of growth in these markets. In the US, pharmaceutical manufacturers’ efforts to expand access to and awareness of patient assistance programs, as well as co-pay subsidies for patients in need, are limiting the impact of the economic downturn to some extent. Consistent with the trends of the past several years, the year is expected to reflect a significant imbalance between new product introductions and patent losses. This is the primary factor limiting global pharmaceutical market growth to the mid-single digits. At the same time, new products that will enable innovative approaches for treating patients suffering from diseases such as osteoporosis, respiratory ailments, thrombosis, multiple sclerosis and cancer are not expected to generate the same magnitude of sales as products losing patent protection. Despite economic conditions significantly affecting some markets—notably Russia, Turkey, South Korea and Mexico—the seven pharmerging countries that include China and India are expected in aggregate to grow by 12 -14 percent in 2010. China’s pharmaceutical market is expected to continue to grow over 20 percent annually.  The economic climate has heightened concerns by payers about healthcare funding, and intensified their efforts to limit access to non-generic drugs. This has pushed the countries having healthcare system in place to take necessary measures such as encouraging generics players. A number of events may occur in 2010 that also could have a long-term effect on the pharmaceutical market. These include the potential for passage of comprehensive healthcare reform in the US as well as legislative or  regulatory actions in other countries, the magnitude of the H1N1 pandemic, and the timing and extent of the global economic recovery. The fundamentals for biotechnology industry, such as the number of products in clinical trials, new product approvals, profitable biotech companies and industry mergers and acquisitions will continue to remain favorable. The biotechnology industry like 2009 will continue to pass through tough period from venture capitalists. There will be casualties along the way among the undercapitalized and under-performing companies. The companies from the APAC region such as contract manufacturing particularly in generics and active pharmaceutical ingredients, contract research, clinical research continue to do better due to lower costs of production in general as well as in improving ability of international regulators expectations. Aitken of IMS Health notes, “While our outlook for the global market is more positive than earlier in the year, the fundamental dynamics of the innovation cycle, funding pressures, and the broader macroeconomic environment will result in mid-single-digit growth over the next five years. Notwithstanding the improved prospects in the US market, the drive by pharmaceutical manufacturers to adapt to the longer-term marketplace trends and evolving patient needs will continue undiminished.” “In future, pharmaceutical companies will not be able to “profit alone”. They have to ‘profit together’ by collaborating with a whole range of organizations, from academic institutions, hospitals and technology providers to companies offering compliance program, nutritional advice, stress management, physiotherapy, exercise facilities, health screening and other services,” observes Abhijit Ghosh, Pharmaceutical & Life Sciences Leader, PricewaterhouseCoopers Services LLP (Singapore). The life sciences companies have to look for collaboration, consolidation and profit sharing to be successful in near future. Expectations Expect industry-wide, intense efforts to reduce healthcare costs by hospitals, physicians, payers, employers and other providers. The US Congress passes healthcare reform legislation – as it hopes to do – expect major adjustments that would include insurance market and payment reforms, the addition of dozens of new agencies and grant programs, reimbursement and pricing pressures, increased oversight, tax changes and the overall implications of increased coverage and consumer demand. Physicians and providers will be scrambling in 2010 to adopt healthcare IT to reap bonuses in 2011 under the American Recovery and Reinvestment Act. Expect greater emphasis on Medicare fraud and abuse recovery. The Obama administration has boosted its fraud and abuse budget for 2010 by 50 percent, and a significant portion is dedicated to prosecution and enforcement. An increase in enforcement for Medicare billing errors is also expected. The technology and telecommunications sectors will become leading players in healthcare. With a huge boost from the 2009 stimulus package for broadband funding and healthcare IT expansion, technology and telecommunications companies are aggressively capturing a growing share of the healthcare business. Big pharma’s role will grow. The role of pharmaceutical and life sciences companies will evolve from manufacturer and supplier to full partner on the healthcare delivery team as its focus shifts from lab-based outcomes to promoting prevention and patient outcomes. Physician groups will join health systems. The percent of hospitals employing physicians has nearly doubled since 1994, and PwC expects the trend will continue in 2010 as physicians seek greater stability and electronic connectivity. Alternative care delivery models will emerge, as traditional care delivery models will give way to alternative models of care outside of physicians’ offices and hospitals. Expect to see an increase in the number and scope of services offered by work-site and retail health clinics and home health services as well as other technology enabled delivery such as e-mail, telehealth and remote patient monitoring. H1N1 will elevate emphasis on readiness for public health outbreak. Another wave of H1N1 flu in 2010 will put pressure on healthcare organizations, public health officials and employers to re-evaluate readiness for a major public health outbreak. Community health will become a new social responsibility. In 2010, a new social responsibility for community health will emerge among employers, healthcare leaders and community leaders, with a major boost in funding from the government. Source: PricewaterhouseCoopers’ Health Research Institute BioSpectrum Bureau ]]> <![CDATA[Bionomics of Biosimilars]]> https://biospectrumindia.com/news/95/2463/bionomics-of-biosimilars.html https://biospectrumindia.com/news/95/2463/bionomics-of-biosimilars.html Wed, 13 Jan 2010 20:13:00 +0530 Bionomics of Biosimilars Biosimilars are said to be the next big cash cow for India. However, players have many knots to untangle before they can have a firm grip over the economics of the market. Biopharmaceuticals continue to outperform the pharmaceutical market with the US alone predicted to touch a figure of about Rs 2.79 lakh crore ($60 billion) by 2010. The latest agenda for many companies now is to utilize the opportunities in biosimilar market. An increasing use of biologics in disease areas such as cancer, auto-immune and orphan diseases, in addition to healthcare cost containment, has driven the growth of biosimilars. In a short term, biosimilar market growth will be driven by drug classes including erythropoietin, filgrastim, human growth hormone (HGH) and insulin. Gradual expiry of patents will create significant market opportunities for developers through to 2016. Between 2012-19, the market will see a patent expiry of a whopping Rs 2.79 lakh crore ($60 billion) of biotech drugs with Amgen being the most hard out of all the companies. Its blockbuster drug for anemia, Epogen which had a sale of about Rs 11,600 crore ($2.5 billion) in 2008 will lose its patent in 2013. Other blockbuster drugs, Neupogen will lose its patent in 2013 while arthritis drug, Enbreal, will lose its patent in 2012. Epogen, Neupogen and Enbrel together accounts for half of Amgen’s total revenue. Companies like  Merck, Novartis and Pfizer are already on the run to make biosimilar versions of Epogen while Pfizer is also looking at coming up with a biosimilar version of Sanofi Aventis’ Lovenox. Indian scenario India is not far behind as biosimilars spell big opportunities especially for companies like Dr Reddy’s Labs, Ranbaxy, Biocon, Shantha Biotech and Intas Biopharmaceuticals, who are actively involved in the space. The Indian biosimilars market in 2008 was around about Rs 930 crore ($200 million), with an expectation to reach around about Rs 2,698 crore ($580 million) by 2012. Jay Desai, founder and CEO, Universal Consulting, says, “In India, the interest in biosimilars is additionally spurred on by multiple factors. Firstly, under the Trade Related Intellectual Property Rights (TRIPS) agreement, pre-1995 product patents were exempted thus granting some biologicals, the rights to continue manufacturing. Secondly, biotechnology drugs (besides insulin) are free from the government’s price control act, allowing independence in price setting. There seem to be signs of acceptance of locally manufactured biosimi lars among healthcare professionals within the country.” The upcoming oncology market is one of the prime targeted areas for many companies. The current size of the Indian oncology market is about Rs 86.50 crore($18.60 million), which is expected to be over about Rs 232 crore ($50 million) by the end of 2010. Tapan Ray, director general, Organization of Pharmaceutical Producers of India (OPPI), says, “Oncology being one of the fastest growing therapy segments, sharp focus on this area is indeed a step in the right direction.” There are around 25 Indian players in the space with around 40-50 products already being sold in the Indian market and some being sold in the unregulated markets too. “Around 15 brands of EPO, eight-nine GCSF and three-four insulin products are being sold in the Indian market,” informs Dr Dhananjay Patankar, COO, Intas Biopharmaceuticals. According to estimates, in India, EPO has clocked a sales of $22 million (about Rs 102 crore), c-GSF has sales of about Rs 51 crore ($11 million), interferon has a sales of $22 million, (about Rs 102 crore) streptokinase has sales of about Rs 74.40 crore ($16 million), and insulin has a sales of about Rs 255 crore ($55 million). Dr Reddy’s Labs created a niche in the oncology with the launch of its affordable biosimilar product, Reditux, in 2003. Biocon has four products developed in India; viz EPO, insulin, GCSF and streptokinase with its human insulin product being sold in the market at a discount of almost up to 80-85 percent. Glenmark is planning to come out with its first biotech product by 2010 from its biological research establishment located in Switzerland. Similarly,Ranbaxy with its strategic collaboration with Zenotech Laboratories is planning to market G-CSF oncology products in various markets of the world like Brazil, Mexico, CIS and Russia. Reliance Life Sciences launched three biosimilars - ReliPoietin Erythropoietin (EPO), ReliGrast Granulocyte Colony Stimulating Factor (G-CSF), and ReliFeron (Interferon Alpha 2b) in the domestic market in 2008. “We are concurrently conducting clinical trials for two biosimilars — Erythropoietin and GCSF — in Europe,” says KV Subramaniam, president and CEO, Reliance Life Sciences. Intas Biopharmaceuticals has launched four biosimilar products - G-CSF, EPO, Interferon Alpha Beta (IFN- ) and Peg-GCSF in international as well as domestic markets. “Our strategy for regulated markets would be a step wise approach from API to biosimilars to contract research to collaborative research and biobetters to novel biologics. The company is aiming to replicate its biosimilar success of India and semi-regulated markets success in Europe and North America.” Wockhardt has biosimilar products at various stages of development and is targeting the US and EU markets. Cipla has entered into an 50:50 joint venture (JV) with a Chinese company for biosimilars. The JV called BioMab, expects the first product to be out by 2010. However, it will not be a smooth road for these players. “There are five bridges that an Indian biopharma company must traverse, all of them are equally important to success. These bridges are those of affordability, assets, approvability, acceptability and availability. The ability to safely cross over these spans, will determine the level of success we are likely to see in the Indian biosimilars industry,” adds Desai. Above all, industry experts fear that the market will see the mushrooming of a number of other players who are on the run to make quick money but will come out with products without any quality. EU, US markets: Not a cakewalk Attaining a firm grip in the EU and the US markets will not be a cakewalk for India. With EU already out with a pathway in 2006 and the US FDA scheduled to come out with one in another five years, Indian players are investing heavily keeping these two markets in mind. However, industry experts claim that it will be a different ball game altogether. Says Desai, “The current theory-in-use is that India will at some point in the not-too-distant future, replicate the relative success of its pharma generics industry in the biosimilars market worldwide. The theory-in-practice may well turn out to be quite different.” “The estimated cost to develop a biosimilar is in the range of $10-40 million, largely because of the need for extensive safety and efficacy testing when compared with $1-2 million for a traditional generic,” claims Subramaniam. Post the approval of its first biosimilar product, Omnitrope, Sandoz‘s penetration levels in the European market is still very low. According to Peter Wittner, senior consultant, Interpharm Consultancy, “It will be a bumpy road for India. Registering a biosimilar product in the EU (EMEA) will be easier since the guidelines have already been laid out, yet the cost of compliance is extremely high. Moreover, in regions like the EU, the entry cost is high leading to low competition and fewer players.” Need for an independent regulatory body The call of the hour is to set up an independent regulatory pathway in India for the approval of biosimilar products. At present, the Drug Controller General of India (DCGI) gives the go ahead for market approval both for generic as well as biotech drugs. Without a regulatory body, there might be chances of low-quality products being sold, which in turn can ruin the reputation of the Indian industry. In 2004, there was a call by a section of the industry for an independent body for approval of biologics. Nothing concrete has come up since then. Dr Patankar, who then represented the Confederation of Indian Industry (CII), recalls “The need to streamline and draft guidelines for biosimilar drugs first came about in 2004 with the setting up of the Mashelkar Task Force which had representatives both from associations and the industry.” Only a few recommendations from the task force are being implemented today. All eyes are now on the WHO guidelines for biosimilars which can bring about some stability. “The Indian government is looking into the issue and it has been sharing details to the industry and also taking in their suggestions,” adds Dr Patankar. Alternate options for investors There has not been much activity from private equity and venture capitalists too. In terms of private investment, Intas Biopharma and Bharat Biotech are the two big names known where PE funding of both companies put together come up to about Rs 139.60 crore (almost $30 million). “There are not many deals happening in the PE and VC space. This is because of the huge risk involved in biosimilars. A huge chunk of investment today comes from promoters. However, I gradually see an interest picking up for this space,” mentions a well-known private equity investor who is keeping a close tab in this space. Investors believe that a good alternative would be for Indian companies to enter into licensing agreements and alliances for biosimilars especially when it comes to the regulated markets. This, they believe, can attract some PE/VC investment. After EPO, insulin, GCSF and interferons, investors are now bullish about the Mabs space. With the patent expiry of products like Herceptin, Humira and Rituxan, Mabs are in the pipeline for many Indian players. Currently, Mabs generate global revenues of around about Rs 93,000 crore ($20 billion) and represent the fastest-growing segment within the pharmaceutical industry. Competition from China There are apprehensions of India facing tough competition from China. Experts are divided in their opinion as to which country has the upper hand. China at present has a number of small players operating in the space. Dragon Pharma alone has 20 GCSF products in the pipeline. “China has the edge over us in terms of manufacturing and expertise and hence they might eat up a major share of the global biosimilar market,” says Dr Arumugam Muruganandam,senior scientific manager, R&D, Biocon. However, experts also believe that India has the edge over China because of a large number of ‘big players’ in India participating in the space which is not yet to be seen in China. Biobetters: The future The new turf for biotechs, both innovator and biosimilar companies alike are ‘biobetters’, which are second generation biopharmaceuticals showing improved performance and efficacy over the innovator product by a slight modification of the molecule. There can be two possibilities. The first being a biosimilar company which has a drug target in mind, has the proven clinical results but then induces a slight clinical change in the molecule design which then brings out a product which is better than the innovator product. The second situation is when an existing molecule of an innovator product is modified to bring out a drug which does not exist in the market at all. Industry experts however opine that Indian players should take one step at a time and have to shift their focus on biosimilars. Nayantara Som in Mumbai ]]> <![CDATA[Nanobio garments for wellness]]> https://biospectrumindia.com/news/95/1470/nanobio-garments-for-wellness.html https://biospectrumindia.com/news/95/1470/nanobio-garments-for-wellness.html Wed, 13 Jan 2010 20:06:00 +0530 Nanobio garments for wellness These garments have anti-microbial, anti-allergic and moisture-retaining capacity and will be beneficial in case of infections and allergies. New-Delhi based Advantage Organic Natural Technologies is exploring the concept for the first time in India under the brand name Joy of Life and has obtained patent for the product. Imagine, the clothes you wear are not only comfortable but also have healing and medicinal properties, thus providing a combination of comfort as well as wellness. Your imagination can now become a reality as 'Meditek' garments, a joint venture of Advantage Organic Natural Technologies (AONTL) and textile technologists from IIT, New Delhi, will soon hit the market. Explaining the concept of ‘Meditek’ garments, Rajiv Rai Sachdev, managing director, AONTL, says, “These are 100 percent organic/ natural garments with wellness properties. The garments are coated with various herbs with medicinal and aromatic properties, healing crystals and natural bioengineering extracts.” During heavy work-out, we generally perspire leading to the opening of pores, thus making us prone to external microbes. So, what can be the solution? The answer is the clothes made from chemically treated fabric that can purge the dirt. “These garments will be very beneficial in case of infections or allergies, and even otherwise as they have antimicrobial, anti-allergic and moisture retaining capacity. AONTL, under the brand name Joy of Life, is exploring the concept for the first time in India and has obtained patent for the product,” adds Sachdev. AONTL is setting up 'Meditek' garments manufacturing unit at Kandaghat in Solan district, Himachal Pradesh. “The project has been approved under single window clearance policy of the state government and 16,000 sq.m. of land has been allotted. Construction work is going on and the facility is likely to start the production soon. “Until the company’s unit is complete, the products prototypes will be developed using other existing manufacturing processing units taken on lease and hire basis,” reveals Sachdev. “AONTL has inbuilt clean development mechanisms that are 100 percent natural, eco-friendly, saves water, electricity and energy vis-a-vis conventional textile processing methods, and will earn carbon credits for the same,” says Sachdev. Fusing technology with fabric Some of the most renowned textile technologists of India, from the Department of Textile Technology, IIT, New Delhi, having vast experience in similar technological fields will jointly set-up a research facility in IIT, New Delhi, for enhanced research in similar technology applications. The outcome of the research, be it in the form of technology or products will be marketed by AONTL and the Department of Biotechnology (DBT) will be the funding agency. The clothes will be coated with nanosilver particles, natural anti-microbials like chitosan, aloe vera and lemon green including healing crystals. Speaking about the nature of collaboration of IIT, New Delhi, with Advantage Organic, Dr ML Gulrajani from of the Department of Textile Technology, IIT, New Delhi, says, “The company has been incubated at IIT, New Delhi, which provides various technological assistance to the company to ensure perfection at the pilot scale and will subsequently scaleup for regular production. IIT will provide the technologies and other technical support in setting up the production facility and marketing activities.” On the use of the nanotechnological and biotechnological applications and their utilization in making the final product of Advantage Organic, Dr Gulrajani says, “Various combinations of bio and nanotechnologies with wellness properties are being used in the production of garments.” Further speaking on the nanotechnological applications in textiles, Dr Gulrajani says, “Nano-silver is also finding considerable use in the treatment of textile products like socks to make them odorless that inturn demands less frequent washing thereby making them more sustainable. A combination of nano-silver and chitosan will make it an effective value-added multi-functional finish.” “The nano-silver when in contact with bacteria and fungus will adversely affect cellular metabolism and inhibit cell growth. The nano-silver suppresses respiration, basal metabolism of electron transfer system, and transport of substrate in the microbial cell membrane. The nano-silver inhibits multiplication and growth of those bacteria and fungi which cause infection, odour, itchiness and sores.” Dr Gulrajani adds. The range of Meditek garments that will be launched soon include yoga wear, hospital clothing and kids wear. Activities of AONTL in IIT, New Delhi Optimization of enzyme processing of textiles. Establishing procedures for extraction and application of herbal dyes with known medicinal properties. Effect of enzyme finishing on the herbal dyed textile products. Development and application of special nano finishes based on natural ion generating minerals having healing properties. Formulation and application of finishes based on complexes of natural bio-molecules such as chitosan and sericin with silver nano-particles. Evaluation of anti-microbial activity of natural plant extracts on textile substrates, such as aloe vera and lemon grass oil. Micro-encapsulation of natural herbal oils with natural polymers and their application on textiles. Nanobio applications in developing wellness products Processes for the scouring of organic cotton yarns and garments at pilot scale with enzymes namely, pactinases, cutinases and combination of these enzymes with lipases. Technology for the production of purified natural herbal extracts (colorants) using membrane filtration and spray drying. Processes for application of purified natural herbal colorant extracts to cotton yarns and garments in a pilot processing plant to get uniformly dyed products. Standardization of the bio-finishing processes for natural dyed garments with various types of cellulases having different proportions of endoglucanases with minimum cellobiohydrolase activity. Technology for production, formulation and application of finishes based on complexes of natural bio-molecules such as chitosan and sericin with silver nano-particles. Application of finishes based on complexes of natural bio-molecules such as chitosan is a natural polymer available as by-products. The polymers can act as handle modifiers with added properties as anti-microbial, UV protection and cell rejuvenation. Technology for production, formulation and application of finishes based on natural plant extracts on textile substrate such as aloe vera, lemon grass, and neem. Currently, most of the anti-microbial agents used in textile industry are synthetic products such as Triclosan 5-chloro-2-(2,4-dichloro phenoxy)– phenol, Aegis Microbe Shield (3-trimethoxysilyal- propyl-octadecyl-ammonium chloride), Purista poly (hexamethylene biguanide hydrochloride) etc. Technology for the production of nano-particles of ion generating minerals such as tourmaline, Himalayan rock and quartz and the application of these on garments so as to get durable negative ion generating finishes. Application of special nano-finishes based on natural ion generating minerals having healing properties. The company is proposed to develop and evaluate textile finishes based on nano-particles of pyroelectric tourmaline, quartz, Himalayan salt rock and other such minerals. The finish will be developed by embedding the nano-particles of tourmaline in a polymer emulsion that will be used as finish. Processes for micro-encapsulation of natural herbal fragrances and other functional molecules in natural bio-polymers and their cross-linking with cotton garments. Rahul Koul in New Delhi ]]> <![CDATA[India ready to battle swine flu]]> https://biospectrumindia.com/news/95/2761/india-ready-to-battle-swine-flu.html https://biospectrumindia.com/news/95/2761/india-ready-to-battle-swine-flu.html Wed, 13 Jan 2010 20:02:00 +0530 India ready to battle swine flu The battle against swine flu is getting intensified with the fruitful results of the clinical trials for developing H1N1 vaccines and diagnostic kits by both domestic and international pharmaceutical and diagnostic companies. The rapid pace at which H1N1 spreads has created panic among people from all across the world. The surge is expected to continue for more than a year from now. Understanding the gravity of the situation, the Indian government has been taking various initiatives to procure vaccines from international pharmaceutical companies to curb the spread of the pandemic and to enhance the development of indigenous diagnostic kits and vaccines for H1N1. Swine flu vaccine scenario In August 2009, the Indian government approached four international pharmaceutical companies that are manufacturing H1N1 vaccine, but no pre-bookings were made. The government said the booking would be made only after conducting the clinical trials to ensure the safety and efficacy of the vaccine in the country. In the first week of December 2009, GlaxoSmithKline (GSK) got the approval to start its clinical trials in India. Two other pharmaceutical companies, Baxter and Novartis have also got the approvals to conduct clinical trials. The process will take at least a couple of months to complete. While commenting on the current status of GSK’s H1N1 vaccine, a spokesperson of the company says, “We are in talks with the government on the procurement and supply of H1N1 vaccines and are not in a position to further comment on the said matter.” French drug company, Sanofi-Aventis’ vaccines division, Sanofi Pasteur, is one of the international companies that is expected to join hands with the government in the fight against swine flu. Meanwhile, during a Parliament briefing in November 2009 on the development of swine flu vaccine, Ghulam Nabi Azad, health minister of India, said that India would be able to indigenously develop swine flu vaccine by June 2010. According to Azad, three Indian companies — Serum Institute of India, Bharat Biotech, and Panacea Biotec — are working towards developing indigenous vaccine for the swine flu and the clinical trials would start in January 2010. To cover the interim period, the government is importing pandemic vaccine to vaccinate the high risk group. So far, the government has procured 40 million capsules and 400,000 bottles of Oseltamivir, the drug used to treat swine flu. Approvals and partnerships On the clinical trial front, the animal trials for the much-awaited H1N1 vaccine have been completed by the Pune-based Serum Institute of India (SII). The company has also started its human clinical trials. On the other hand, Ahmedabad-based vaccine maker, Zydus Cadila has filed the first clinical trial protocol with the Drug Controller General of India (DCGI) and has entered the race to launch H1N1 swine flu vaccine in India. Two multinational drug makers — GSK and Baxter International Pharmaceuticals has formed a joint venture with Novavax, a US-based clinical- stage biotechnology company, to develop, manufacture and market vaccines, pharmaceuticals and diagnostic products in India. The joint venture will develop and commercialize Novavax’s seasonal influenza virus-like-particle (VLP)-based vaccine candidate and Cadila’s therapeutic vaccine candidates against cancer as well as its adjuvants, biogeneric and biological diagnostic products for the Indian market. Ahmedabad-based Intas Pharmaceuticals (Intas) has entered into a strategic partnership with US biotechnology company, Amarillo Biosciences, Inc (ABI), whereby Intas will sponsor clinical trials of ABI’s orally administered interferon-alpha lozenges for influenza, which could also be used in combating the H1N1 virus. When asked about the prospects of Intas Pharmaceuticals-Amarillo Biosciences partnership, Dr Samir Sangitrao, assistant general manager - regulatory affairs, Intas Biopharmaceuticals,says, “Intas has submitted the required documents to DCGI for approval of its clinical trial in India. We are expecting the approval very soon. After getting the approval, Intas is planning to conduct a therapeutic clinical trial covering 500 patients with Amarillo Biosciences’ patented orally administered interferon-alfa lozenges. Amarillo has already completed animal studies including toxicity studies as well as several other clinical trials in the US and rest of the world.” “Intas is developing a natural interferon-based therapeutic solution for influenza in general (which will also cover swine flu). Oral interferon will be used to prevent influenza, and, as a treatment, it will also be used to reduce the severity of symptoms. The flu virus does not mutate to evade the effects of interferon. Oral interferon will have no interactions with influenza vaccines,” he adds. He further says that the ongoing flu clinical trial in Australia, which is preventive in nature, is well-timed to help Intas deal with the next wave of swine flu or any other viral respiratory infections efficiently. Report of this preventive study is expected in a few months from now. This will further enhance the usability of orally administered interferon-alfa lozenges for preventing influenza and decrease the morbidity caused due to influenza. Diagnostic kits The Defense Research and Development Organization (DRDO), a premier defense laboratory in India, has developed a swine flu detection kit and the process for transferring the technology for commercialization is yet to be initiated. This development was informed by AK Antony, defense minister of India, in a written reply to the Lok Sabha in the last week of November 2009. DRDO’s diagnostic kit is a rapid and cost-effective swine flu virus specific isothermal gene amplification assay for reliable and early clinical diagnosis of H1N1 in human patients. The defense minister also emphasized that the kit works on a single-tube method as compared to WHO approved Center for Disease Control (CDC) recommended real-time reverse transcriptase polymerase chain reaction test system. The assay is based on the principle of the isothermal gene amplification protocol. No expensive real-time PCR equipment is required as the result can be monitored by the naked eye. The DRDO developed method gives results in an hour as compared to the three-four hours required for the WHO-approved CDC-recommended kit. The DRDO kit has been validated at the National Center for Disease Control, New Delhi; Post Graduate Institute, Chandigarh and the National Institute of Mental Health & Neurosciences, Bangalore. Bangalore-based Bhat Biotech, is also in the process of developing a H1N1 detection kit. Dr Shama Bhat, managing director, Bhat Biotech India, says, “We have been developing diagnostic kits for H1N1 virus detection for the past four months. We are planning to have both quantitative PCR (qPCR) and rapid protein-based kits.” “Bhat Biotech is collaborating with a German company for developing qPCR-based kits. Within a month, soon after the validation, the kits will be available in the market. For the past three months, we are also working on the protein-based kits. Due to the lack of positive samples, it is very difficult to test the kits. To overcome this obstacle, we will be collaborating with some institutions, where this test can be conducted,” adds Dr Bhat. The way ahead One of the challenges posed by the H1N1 virus is the mutation of its strain. Though there were not much mutations identified in India, Indian vaccine manufacturers have to take additional measures to tackle this pressing need. “Since swine flu virus is expected to mutate a lot, developing a vaccine will not be a permanent solution. Vaccine efficacy varies yearly due to antigenic drift. Anti-viral drugs lead to viral resistance,” says Dr Samir Sangitrao. The mutation of the swine flu virus is one of the major areas of concern but with the kind of domestic and international expertise, India can overcome the obstacle. Pradeep Kumar in Bangalore ]]> <![CDATA["We are seeing excellent growth in India, China"]]> https://biospectrumindia.com/news/95/2630/we-are-seeing-excellent-growth-in-india-china.html https://biospectrumindia.com/news/95/2630/we-are-seeing-excellent-growth-in-india-china.html Wed, 13 Jan 2010 19:57:00 +0530 "We are seeing excellent growth in India,China" -Dr Poonam Taneja, director, Global LCM Sales, and Asia and Latin America Distributor Sales, MDS Analytical Technologies US-based MDS Analytical Technologies is a leading global supplier of life sciences tools that comprises two main channel brands, MDS Sciex and Molecular Devices. MDS Sciex offers proven market leadership in mass spectrometry and Molecular Devices sets the standard for high-performance bioanalytical measurement systems. The company has recently entered into an agreement to sell MDS Analytical Technologies to Danaher Corporation. Dr Poonam Taneja shares with BioSpectrum the company's progress in the last one year and plans for 2010, and beyond. How do you rate your business performance in the fiscal year 2009, especially given the difficult economic environment? We have had high double digit growth in revenue last year with Molecular Devices products in India. Spinco Biotech is the exclusive distributor for all Molecular Devices products for India. Spinco Biotech for the second year in succession has proved to be a valuable channel partner particularly for our multimode microplate readers, electrophysiology systems, and drug discovery systems. A major part of this growth came from CROs and Indian pharma companies for our drug screening technology platforms. How does Molecular Devices plan to sustain and exceed such enviable growth rates? As pharma companies in India continue to invest in novel drug discovery programs, we expect to see a growing need for highend drug discovery technologies. We believe researchers in India will adopt high content cellular imaging systems given the research progressing in these areas and our successes in rest of the world. This technology provides scientists with information on how potential therapeutics effect cells and cellular processes. Moreover, as government funding expands, we expect the revenue from microplate readers and washers to bring in additional level of growth. What changes can we expect for Molecular Devices once the acquisition by Danaher Corporation is completed? As you are aware, Danaher Corporation has agreed to purchase Molecular Devices from MDS. Danaher, based in Washington, US, is a successful, publiclytraded company with more than 50,000 employees, over $12 billion (about Rs 56,000 crore) revenue in 2008, and comprises of four market segments: medical technologies, professional instrumentation, industrial technologies, and tools and components. Danaher sees this acquisition as a logical extension of its long-term strategy to expand its presence in the life sciences instrumentation markets. They are excited about the Molecular Devices technologies, the people and the opportunity to build an even stronger and more successful business. Danaher has a reputation for acquiring solid companies in attractive markets, with strong brands and bright futures, and they have made over 50 successful acquisitions since 2002. It is their intention to further the capabilities of the Molecular Devices instruments by fostering the innovation of new products. What new products will Molecular Devices be launching in 2010? Molecular Devices will continue to offer innovative solutions for life sciences research and drug discovery. We have had several new product enhancements throughout the previous year. Recently, we expanded our SpectraMax Microplate Reader platform with the launch of the faster throughput SpectraMax L Luminometer and the new upgradeable SpectraMax M3 and M4 multimode readers. Which technologies will be most exciting for the research market in India? All of our leading technologies such as microplate multi-mode readers and washers, high-end technologies including Flipr Tetra for drug discovery screening, the high content live cell screening systems for cell-based assays and automated electrophysiology systems for ion channel screening, are directly relevant to the rapidly expanding biotechnology, research, and clinical markets in India. Describe your progress in the drug discovery market in India? We have several drug discovery systems installed in various pharma companies throughout India, and have additional forthcoming purchase orders from government laboratories, biotechnology and pharma companies. Our distributor partner, Spinco Biotech, has been successful in selling and supporting our drug discovery systems such as FlexStation, Flipr Tetra, Threshold and Multi-mode Micro Plate readers. What fuels the market for drug discovery products in India? Most of the growth for drug discovery products in India is from CROs and pharma/ biotech industries from their domestic and international projects for the drug discovery program. Investors worldwide are recognizing the need for investing in this growing economy. Which countries in Asia are providing better growth rate for Molecular Devices? We are seeing an excellent growth throughout Asia, especially in India and China. We have instrument demonstration facilities in India, China, Singapore and Australia, and provide hands-on applications workshops and seminars throughout Asia Pacific for all of our products. We have established a regional team of Molecular Devices technical and service specialists to ensure that we are providing complete support to our customers. We see India as a high growth market. We view the entire Asia Pacific as the growth market. We have established a regional dedicated team of Molecular Devices technical and service specialists to work with our distributor partners and support the customers in India. We regularly conduct technical hands-on workshops, user meetings and research seminars throughout this region. Our ongoing collaborations with customers in India have further facilitated our understanding of their research applications and needs. For this year, what is the company's strategy for growth? Molecular Devices will continue the company to grow, both organically through development of innovative products and, acquisition and licensing of novel technologies. Jahanara Parveen in Bangalore ]]> <![CDATA['India has vibrant biotech, pharmaceutial sectors']]> https://biospectrumindia.com/news/95/1291/india-has-vibrant-biotech-pharmaceutial-sectors.html https://biospectrumindia.com/news/95/1291/india-has-vibrant-biotech-pharmaceutial-sectors.html Wed, 13 Jan 2010 19:49:00 +0530 "India has vibrant biotech, pharmaceutial sectors" -Carl-Johan Ivarsson, president, Qlucore The Swedish company Qlucore was founded in early 2007 and the first product released was the ‘Qlucore Gene Expression Explorer'. The bioinformatics software developer has recently entered the Indian market by signing an agreement with JH BIO Innovations, a specialist Indian distribution company that caters to major pharmaceutical companies, research institutes, and universities in India. Qlucore has received a warm welcome from the Indian market with many companies downloading trial versions of its data analysis software. Qlucore’s latest software, Qlucore Omics Explorer, has been developed for the life science, agricultural and biotech industry. With its highly intuitive user interface, Qlucore Omics Explorer allows researchers to shorten analysis time and add more creativity to research, thanks to the product’s instant response and statistical analysis capabilities. In an exclusive interview with BioSpectrum, Carl-Johan Ivarsson, president, Qlucore shares more insights. Can you tell us about Qlucore Omics Explorer and its applications? Qlucore Omics Explorer is an enhanced data analysis tool that has been developed for the life science and biotech industries. It allows scientists and biologists to explore different hypotheses and alternative scenarios within seconds. The software is therefore invaluable for unveiling important new discoveries, as it allows the actual researchers, the people with the most biological insight, to study the data and to look for patterns and structures, without the help of statistics or computer expert. The product can be used on any multivariate data, including data from gene expression, protein array, DNA methylation and proteomics experiments. Who funded the product’s development? Qlucore started as a collaborative research project at Lund University, Sweden, supported by researchers at the departments of mathematics and clinical genetics, in order to address the vast amount of high-dimensional data generated with microarray gene expression analysis. Today, Qlucore remains as a privately-owned company that is committed to achieving this same goal through a dedicated program of product development. Can you elaborate on Qlucore’s growth plan? Qlucore currently has customers in eight countries, and we are doubling our sales each year. We expect to sustain this rate of growth for the next few years. What is the company’s strategy for growth? The first step is to create a broader awareness of Qlucore. This can be achieved by working closely with our distributors, agents and other strategic partners in selected countries. Why is India an important market for Qlucore? India has vibrant and fast-growing biotech and pharmaceutical sectors. As such, India is currently educating a lot of researchers in these and other related areas, and the Qlucore software will play an important role in their research. Which are the other Asian regions your products are marketed? China will be the next big step, and we are already speaking to a number of distributors and agents in this area. Who are your major clients? Many well-known research institutions are currently using our software, including the National Cancer Institute in the US, King’s College London in the UK, France’s National Health Institute (INSERM), as well as leading universities in both Sweden and Germany. What will be the main areas of focus for Qlucore? We typically focus on data that is derived from life sciences industry, but future possibilities could include virtually any project where the amount of data being produced is very large, such as complex financial applications. Jahanara Parveen in Bangalore ]]> <![CDATA['Indian biotech needs stringent regulations']]> https://biospectrumindia.com/news/95/6699/indian-biotech-needs-stringent-regulations.html https://biospectrumindia.com/news/95/6699/indian-biotech-needs-stringent-regulations.html Wed, 13 Jan 2010 19:35:00 +0530 “Indian biotech needs stringent regulations” —Gunther Winkler, senior vice-president-International, Biogen Idec It is not everyday that we see bigwigs from the ‘Big Biotech’ bandwagon coming down to India. So when Gunther Winkler, senior vice-president - International, Biogen Idec made a recent visit to India, we did not miss the opportunity in pinning him down for an interaction. In a free-wheeling interview with BioSpectrum,Winkler was extremely candid about the need for the Drug Controller General of India (DCGI) to come up with a compact and stringent regulatory structure, and his apprehensions for India in terms of Biogen’s investment plans to have a huge presence in India. In terms of large scale investments, how is Biogen looking at India as a prime destination? India is an important place in terms of executing our Asia strategy. This includes accelerating our R&D and doing it more cost-effectively. We have been successful in the last two years since we set our base here. Indian physicians are highly educated, have good knowledge about the field, and are good in spoken English. The main strategy is to expand our product pipeline into the Indian market. At the moment, I would not like to comment on our investment numbers. We have realized that many diseases which have been characterized and diagnosed in the West have not yet been diagnosed here. So we will be investing in education, both for doctors and patients, especially for multiple sclerosis; the numbers of which are rising in India than what is given in the official figures. By investing money in education, we will then bring our products into the market. We will also look at business deals. For the last two years, we have been looking at potential research partners, but have not found one as yet, strategic moves of investments like moving up a manufacturing facility from the West to India are also in the pipeline. What is it that you are looking for in a business partner? How do you think that can be achieved? I think we have not been able to find the right partners because we have been cautious. We have more than 4,200 people worldwide, and getting any significant partners would increase that number. We are looking at a partner who can help us develop our innovative pipeline because we are a company that brings out innovative products for the patients. Now, we are looking for partners who can help us create and develop new products. Which disease portfolios are you looking at in India ? Currently if you look closely, the incidence of heart-related diseases is showing a sharp rise, and India today has the highest percentage of heart diseases. We do have existing products for heart diseases in our portfolio. There is a strong rise in rheumatoid arthritis in India and immune-related diseases. There is no shortage of bringing value to the patients with our existing portfolio. Are there any new products that will be launched next year in India? We will be launching our innovator product by January 2010, but on generic pricing. Here, we will be relaunching Avonex, an interferon for multiple sclerosis treatment which is our flagship product. This time, the launch will be under our brand and sales force. What is your opinion about India as far as R&D investment in biotech is concerned?   After several interactions with the DCGI, I have realized that India is moving in the right direction. First of all, they understand that biotech products are different from small molecule products; the former are much more difficult to reproduce and mimic for biosimilars than it is with small molecules. The DCGI is now in the process of putting some regulations. Coming up with regulations for biosimilars is very complicated. Europe has come up with a pathway but it is not perfect. US has been in the process for biosimilars regulations for the last three years and is yet to come up with one pathway. It is difficult to configure all the nuances, because we still do not have the technology which allows us to test the product in laboratories. In India, on one side the top companies have a good understanding of what is biomolecule, how to manufacture it, how to  characterize and test it, while on the other, there are small companies who are there to make quick money and go the short-cut way. This can be dangerous because for a molecule which is a million times larger than a small molecule, many things may go wrong that it will harm patients. That is where the Indian government needs to draw the line and come up with strict regulations. Have you raised the issue for an independent regulatory structure for the approval of biotech drugs before the government? Yes, but I think the government is aware about this issue. It will take time. It took a long time in the US for the FDA to segregate into specialized biologics and specialized products in small molecules. I feel that the Indian government will be on a faster track if it learns some lessons from the FDA. There are a lot of products in the Indian market like EPO, Interferon insulin which goes through the same process of approval. Will that be a comfortable point for Biogen? In biosimilars, companies will be targeting the more complex molecule. For the next few years, I strongly believe that there will still be a vacuum in terms of regulations and understanding as to what it really takes to make an effective biosimilar product. During this time, we will be seeing products that are harmful to patients. My message to the Indian players is to be careful. This can ruin the reputation of the Indian industry. As long as the government does not have any regulation, there needs to be an element of self-regulation among players which unfortunately is not happening in India. What were the concerns that you put forward before the government? We have had informal discussions with the government. My message is clear – the technology available does not allow us to test for lab analysis of biosimilars which guarantees that the product is similar to the innovator. Therefore, a company in biosimilars needs to follow strict guidelines as to what pre-clinical and clinical tests needs to be done to issue safety efficacy. You have emphasized on the enforcement of stringent laws in clinical trials in India. Has that held you back from working in this country? Nothing of that sort, but there needs to be a compliance in the future. Things will happen. But if compliance is lacking and there is a fall out of IP issues then, we will see companies moving out of the country. What is your observation with regard to the comparison between India and China? Who is going ahead? We are present in China. It is difficult to say who is ahead but I can definitely say that the country which is ahead will have better regulatory guidelines and structure; and the country with better IP protection for companies in general will go ahead. Of the two, which country is favorable in terms of regulatory guidelines? In terms of clinical trials, I think India is much ahead because it is faster but China is changing; and are reforming their structure for which they will catch up quickly. Nayantara Som in Mumbai ]]> <![CDATA[Budget 2010: High Expectations]]> https://biospectrumindia.com/news/95/1417/budget-2010-high-expectations.html https://biospectrumindia.com/news/95/1417/budget-2010-high-expectations.html Wed, 13 Jan 2010 19:25:00 +0530 Budget 2010: High Expectations The finance ministry has warned the industries not to expect any major sops in the coming budget which will be presented by the government in February 2010. Last year, the Finance Minister Pranab Mukherjee missed an excellent opportunity to provide fiscal stimulus to the life sciences industry in the Union Budget 2009. But the forthcoming Budget 2010 is yet another opportunity to push the healthcare sector into a higher growth trajectory. Despite major boosters like the removal of surcharge on personal income tax, enhanced group specific exemptions and abolition of fringe benefit tax (FBT), Budget 2009, gave a lukewarm benefits to all and failed to make any long-lasting impression in the pharmabiotech industry. The UPA-II’s first budget presented on July 6, 2009, could not sweep the business sector at large, and like other markets, the life sciences industry too looked disappointed. But the forthcoming Budget 2010 is yet another opportunity to push the healthcare sector into a higher growth trajectory. Research and innovation can play a crucial role in achieving this goal if the government provides ample rewards and recognition. And this requires long-term tax breaks extending well into the next decade. BioSpectrum takes a first person account on how the Union Budget 2010 should be. Need of more tax holidays Dr Bhuwnesh Agarwal, chairman and MD of Roche Diagnostics, says, “Tax holidays must be given to pharma biotechnology and medical devices companies. Custom duties on the import of raw materials for life saving formulations and drug manufacture must be abolished. Such measures will benefit millions in India who suffer from cardiovascular and kidney ailments, diabetes, cancer, asthma as well as other chronic diseases. Fiscal stimulus will make sure healthcare costs in India are within the reach of the common people. High on expectations, low on delivery is how I would describe the 2009-10 budget. Reduction of customs duty from 10 percent to five percent on a few life saving drugs, vaccines and bulk drugs was a welcome move, though not good enough. Abolishing fringe benefit tax was a sensible move, as it was a nuisance for everyone and barely augmented revenues.” According to him, MAT (minimum alternate tax) hike from 10 to 15 percent — the effective rate with surcharges being 17 percent — was a dampener. Foreign companies with a permanent presence in India will now have a higher tax outflow on book profits, adding to the overall disincentives. An ill-timed hike, since this was supposedly a stimulus budget. "Government should relax the custom duty and also more sops should be there for the life sciences industry. Some of the products imported in India for use in research are unique and they should be provided exemption from the taxes," says Neeraj Gupta, director, sales and marketing, Imperial Life Sciences. He maintains that the government must change the existing institutional funding policy. Seasonal funding to the institutes needs to be replaced by funding for the whole year. That would help in reducing the wastages as the institutes do not have to pay taxes time and again while purchasing the research products from biosuppliers. "CROs in India are getting affected by the medical taxes leveled on them. This will ultimately benefit the Chinese CROs who do not have to pay any such tax and thus, affecting the overall clinical research business and thus shooing away the potential clients," Gupta adds. Import duties must be equated Import duties to be equated for government and non-government institutes for all life sciences products used in research, feels Praveen Gupta, vice-president-business development, Premas Biotech. He says, “Provisions for creation of supply centers at key institutes for stocking consumables at equated duties. Export shipments to be simplified.” Looking at the grim recessive period for exports, Praveen maintains that the time lines for biotech export obligations for EOU should be extended, and setting up of a nodal government agency to push Indian IP technologies from biotech SME to VC, biotech and larger pharma companies worldwide. According to Dr Rita Karia, CEO and president, CliniRx, “Government needs to support this potential sector at par with the IT Industry. The tax benefits from the government are crucial to motivate the client and grow this business. So, we expect the government to provide tax incentives for CROs.” More incentives for better healthcare There are some who feel that in order to help the biotechnology research and development (R&D) in the country, government should give further incentives and help promote innovative ways of using biotechnology for better healthcare, and sustainable green technologies. Dr Gopal Dasika, senior vice-president, R&D, Actis Biologics, says, “One of the needs of our industry is good, well-trained scientists. We have many good schools and institutes for training students through undergraduate level, and very few for higher studies in life sciences. Therefore, providing incentives to global leaders in the area of higher education to set-up universities in India would reduce brain drain from India and vastly improve the quality of R&D in our country. The culture of science and innovation would then become commonplace in our biotech and pharma companies.” According to Dipta Chaudhury, program manager - South Asia and Middle East, Pharma and Biotech Practice, Frost & Sullivan, the Central government has initiated and sustained healthcare reforms for rural and the urban - rural population through its past few budgets. While these initiatives are improving healthcare reach for the vast majority of the poor population directly, large corporates are focusing on tier I cities. “There is a need to create initiatives on a Central government level to spur private participation for tier II and tier III cities to ensure sustainable healthcare through all classes of society in India. Also, while tax sops for healthcare infrastructure has been a boon, further benefits for medical devices and for quality medical education would really help spur industry growth," says Chaudhury. Muralidharan Nair, partner - Life Sciences Advisory Practice, Ernst & Young, says, “Biotech is an area which will have an increasing share of global pharmaceuticals and China and Korea have significantly higher capability than us in this area. While we are already delayed, we should do our best to promote this with dedicated biotech fund for assisting new drug and biosimilars.” Improve competitiveness Dharmesh Panchal, senior director of Deloitte, who leads life science and healthcare division is of the opinion that the pharma industry has shown robust growth in the recent years. The global pharmaceutical companies see India not only as an enormous domestic market but also as a sourcing base for generic drugs, bulk drugs and contract research services. India has various advantages to offer such as low cost base and availability of skilled man power. According to Panchal, the expectations of pharma industry from the Budget 2010-11 are towards measures to improve its competitiveness. Listing a few, he maintains that pharma industry expects harmonization of the excise duty rate on active pharmaceutical ingredients (API) and finished formulations. As a result of the fiscal stimulus, the excise duty rate on formulations was reduced to 4.12 percent whereas API continued to be taxed at 8.24 percent. Due to this inverted duty structure, pharmaceutical manufacturers have accumulated cenvat credit in the absence of a refund mechanism. Further, the exemption from customs duties should be granted to diagnostic equipments such as glucometer for diabetes. “The introduction of the GST is the biggest fiscal reform post-liberalization of the Indian economy. GST will significantly impact the supply chain and businesses of pharma companies. Government must provide a clear road map for the introduction of GST to enable the pharma industry to prepare for transition. It is expected that in GST regime, life saving drugs would be exempted and medical devices would be subject to lower band of GST rates,” he adds. The industry also looks forward to capital as well as profit-based incentives to boost the overall capital base of the companies. The income tax holiday under Section 80IB (8) in respect of profits from R&D activities, should be re-instated to encourage the contract research services. The extension of Section 35 [2AB] to MAT calculation would also be a major relief to the R&D activities in their gestation stage. Income tax holiday should also be extended to clinical trial ctivities to make India an attractive outsourcing destination for R&D. Incentives to agri-biotech/seed industry From the nearest budget, Dr Govind Garg, director of R&D, Krishidhan Seeds, expects that while allocating budget, there should be tax exemption for seeds production and processing. Indian agriculture needs constant growth, not only to feed the ever increasing population but also to show resilience in the face of climatic uncertainties. Introduction of Bt cotton,besides increasing the cotton production and bringing buoyancy in textile market, has significantly increased the seeds replacement which has risen from three percent to 15 percent in the last six to seven years. Today, farmers make no distinction between seeds from private and public sectors as they prefer to buy which ever performs better irrespective of the cost. Dr Garg says, “I would consider this as a very positive scenario and if our Finance Minister is serious about assisting the country in achieving envisaged growth of six percent in agriculture, he should give very fresh thought and thrust to policies and support to seed industry with grants and tax concessions.” He suggests that there should be an exemption from income and service tax as the seed industry gets large quantities of seed produced through contract farming with farmers across the states and land holding spectrum. This activity is genuinely an agricultural activity except that it is done on farmer’s field either through lease or contract farming. “I feel there is enough merit that at least for the next five years the income from seeds production and processing should be exempted from both income tax and service tax. All the resources should be diverted to support basic research so that scientists can concentrate on discovery and research to improve productivity. The seed industry which now is realizing the importance of research and development should be encouraged to evolve commercial varieties and hybrids based on the discoveries made in universities and ICAR institutions. It should be encouraged further through concessions in taxes, additional support through public private partnership schemes and rewards based on the excellence of performances of their product,” he says. He also feels that there should be an independent seed performance evaluation. Dr Garg says, “There is a need for development of an autonomous authority for independent evaluation with independent infrastructure for genotypes developed by public and private sectors. This will facilitate the recognition of genuine products developed by both public and private sectors without any bias. This is absolutely essential if the varieties and hybrids of private sector, which also are national property, be protected under PVPFR.” “The present system in my opinion suffers from a contradiction as ICAR and SAU System are both regulators and product developers. Private sector has limited access to AICIP testing system that too, only for hybrids. This prevents them from getting the varieties and hybrids released through normal channels where such testing is essential. The separation of two functions will not only increase the quality of product but will also ensure that only good products reach farmers. There is a need to make proposal for establishment of such an autonomous authority and make budgetary provision for the same,” Dr Garg suggests. Dr KK Narayanan, managing director of Metahelix Life Sciences, along with the members of the special interest group on agricultural biotechnology of ABLE, are of the opinion that it is a well established fact that the agribiotechnology would be playing a key role in enhancing the crop productivity. The group feels that there must be some concessional funding for infrastructure development, concessions on cost of deregulation of genetically modified organisms (GMOs) of national importance and service tax, VAT and tax holiday for agribiotech seed industry. “To avoid litigation and to remove any ambiguity, where the seed companies are engaged in growing the seeds with the aid of farmers where the produce belongs to the seed companies and no risk whatsoever is taken by the farmers, the income thereon should be treated as agricultural income eligible for exemption under section 10(1) of the Income tax Act, 1961. The Central Board of Direct Taxes should issue unambiguous clarification in this regard and treatment of seed industry income as agricultural income,” Dr Narayanan adds. Expectations However, there are some who expects the least from the nearest budget. “To be honest, I do not have any expectations. The finance ministry has lot of demands and priorities, and politics/ politicians always see what is most beneficial for the 'masses',” says CL Rathi, managing director, Advanced Enzymes. “Biotechnology and enzyme industry is not a key agenda for them, and second generation biofuel is yet to take off even in developed world and we are yet to catch up. On taxation front, the new bill is nder consideration which is too broad based. Hence, I do not see any thing specific coming our way,” he adds. What may come, February 2010 is a month to be watched, and the deliberations by the Finance Minister, Pranab Mukherjee is to be pondered. Nayantara Som (Mumbai), Rahul Koul (New Delhi) and Ajeesh Anand (Bangalore) ]]> <![CDATA[ILS enters new market segments]]> https://biospectrumindia.com/news/95/2812/ils-enters-new-market-segments.html https://biospectrumindia.com/news/95/2812/ils-enters-new-market-segments.html Tue, 12 Jan 2010 18:35:00 +0530 ILS enters new market segments Flow cytometry, invivo imaging, diagnostics It has been a long journey for Imperial Life Sciences (ILS) since its inception in 1992 as a distribution house specializing in life sciences research products. Since then, it has come a long way to be among the elite class of Top 10 biodistribution companies in India. Currently, ILS is headquartered at Pace City, Gurgaon, Haryana. In an interview with BioSpectrum, Suresh K Gupta, MD and Neeraj Gupta, director, sales and marketing, Imperial Life Sciences (ILS) share their thoughts on the road ahead for ILS. Excerpts from the interview: Since its inception, how has ILS addressed the needs of the life sciences industry? SK Gupta: ILS provides the Indian researcher with a range of state-of-the-art instrumentation, reagents, softwares and other consumables, providing complete solutions for laboratories working in genomics, proteomics, cell culture, drug discovery and bioproduction. Neeraj Gupta: The objective of ILS has been always to simplify the research process by providing quality products at cost-effective pricing, including, best service with the help of ILS representatives in all the major cities and prompt technical support by field application. Scientists at major locations get quick deliveries by an all India distributor network. ILS has been a major player in every aspect of science to the Indian researcher for the past 18 years. What are the different segments that the company caters to and who are the major clients? Neeraj Gupta: ILS has a multi-pronged approach for life sciences with a focused strategy for the Indian life sciences industry with major divisions like genomics, proteomics, cell biology, molecular and cell imaging, analytical and lifeline divisions. Our major clients include government and autonomous institutes. We also serve major pharma and CRO clients. What was the company’s revenue for the FY 2008-09? What is the expected revenue from the current fiscal? SK Gupta: ILS registered revenue of Rs 102.90 crore in FY 2008-09 as against Rs 88.73 crore in FY 2007-08 making it to the eighth position among the top 20 biosuppliers in India. Instrumentation has been the major growth driver for the company with 60-70 percent of the revenue derived from it. ILS is expecting a growth in the overall portfolio based on the new associations with leading technology providers in India and, is expecting a revenue growth of 30-35 percent in FY 2009-10. What are the major collaborations of ILS? Are there any new collaborations in the pipeline? SK Gupta: ILS with a partnering approach created a niche in the genomics segment with key associations with Agilent Technologies, Stratagene, Caliper Life Sciences, Lonza, IDT, Amresco, GenVault, DiscoverX, and LabWare among others. Simultaneously, based on the needs of the scientific community, ILS has broadened its horizons into proteomics with innovative technologies like the label-free protein-protein interaction platform from ForteBio or OFFGEL Fractionator, which significantly helps the researcher in their work flows. With significant associations ILS has been a major player in the cell biology field, consumables like medias, serum, primary cells and cell culture reagents, which are necessary in every cell culture facility for further expansion into innovation. Neeraj Gupta: We have collaborated with VisualSonics, Bioscan and Faxitron to provide the Indian researcher a complete range of products for in-vivo imaging. In association with Caliper-Xenogen, we provide customers with an optical-based in-vivo imaging. Now with VisualSonics, we provide researchers with an ultrasound-based modalities. Bioscan is a known name in the preclinical market with its range of product for in-vivo imaging like the NanoPET, NanoSPECT and NanoScan, to provide researchers with the world’s leading technology in PET, SPECT and CT. What are the challenges faced by biosuppliers as far as the product supply in India is concerned? SK Gupta: One of the major challenges before biosuppliers in India is that the purchase process in India takes a fair amount of time sometime ranging from six months to one year for major instrumentation business, which overall affects the product supply. Preference of price over technology is also a hindrance to the overall purchase process in India. What are the new segments ILS is taking up? What will be your future strategy for those markets? Neeraj Gupta: ILS is venturing into two major business segments in the life sciences industry, the flow cytometry market and the in-vivo imaging market with a complete plethora of modalities for the needs of the scientists. Our recent collaboration with Amnis Corporation has given us an edge in the flow cytometry market. Soon, ILS will introduce revolutionary and highly cost-effective—maintenance-free and easy-to-use flow cytometer system which can make flow cytometry personal to each cell user. Animal research is a common area for majority of researchers in India and, ILS will be the first company to offer imaging modalities for the same in all respects. Venturing into diagnostics Recently, ILS, which specializes in life sciences business, ventured into the diagnostic industry with its cost effective and sensitive Real Time PCR-based swine flu H1N1 detection kit. Validation of the kit has been done at the National Institute of Virology, Pune, as per the recommendation of the Indian Council of Medical Research, New Delhi, and the Ministry of Health and Family Welfare. The kit has got 99 percent concordance with the results as per the WHO/CDC protocol. “We are planning for the production of these kits to cater to the needs of the swine flu detection centers throughout India. ILS further plans to extend the development of these real time PCR-based kits for the detection of diseases like dengue and hepatitis,” says Neeraj Gupta, director sales and marketing, ILS. Rahul Koul in Gurgaon ]]> <![CDATA[Brothers-in-Business]]> https://biospectrumindia.com/news/95/2124/brothers-in-business.html https://biospectrumindia.com/news/95/2124/brothers-in-business.html Tue, 12 Jan 2010 18:31:00 +0530 Brothers-in-Business Script India's phase I focused success story Business is in my blood. So much so that it has become my hobby,â€? quips Apurva Shah, founder and group managing director, Veeda Clinical Research. Sitting at his plush sea-facing abode in Mumbai, he divulged, â€œI like to see how things come into play, how to create a team and its business. I love to create businesses-good businesses.â€? A telecon with London-based co-founder and brother-in-law, Binoy Gardi revealed the same. â€œChallenging and constantly questioning yourself, as well as other people, will get the best answers which will help in bringing out new ideas and develop the organization,â€? Gardi declares, talking about his day-to-day business modus operandi. From having just two people, namely Gardi and Shah on the deck to an employee strength of over 500 people, and a stupendous growth rate of 70 percent in three years, Veeda Clinical Research is heading towards a Rs 325 crore turnover in the coming three years. Veeda's story is an encouraging tale of translating dreams into reality. Establishing a global presence across Europe, India, the US and South East Asia, through a succession of acquisitions, its success story would not have been possible without the steel grit, determination and passion of this entrepreneurial duo, thus etching a mark in the industry and putting India on the map of global CRO landscape. The Winning Duo Born into a family of well-known businessmen in Gujarat, entrepreneurship is in their genes. â€œTrue. Shah and Gardi were focused on setting up a business right from day one. But it is not just business but coming up with an innovative business product which was their mission,â€? reveals an industry expert. Both the co-founders are known to exude an insatiable thirst to churn out ideas in order to be a cut-above-the-rest. They have the analytical skills to weigh the apprehensions and challenge ferociously the predicaments coming in their way. Above all, before envisaging for any business endeavor, both believe in mentally preparing themselves to zero in on what they cannot do and then move to things that they can do. This is but a formula to keep the company focused on their game plan which is to concentrate only on phase I operations for the parent company, and late phase clinical development for their recently established subsidiary, Veeda Oncology. â€œThis is the DNA of Veeda and before acquiring any company we tell them what we are not. If you cannot do something which is a value addition, there is no point stepping into it,â€? reveals Shah. Their partnership works on the very same principles as a successful marriage. â€œYes, our partnership is like a marriage which requires 100 percent trust and complete openness to each other for any decisions taken. The key is openness,â€? adds Gardi. Yet, they are two different individuals. While Gardi is well-known for his 'out-of-the-box' thoughts, pitching in mammoth ideas, Shah is more of a hands-on-person. Being based out of London and managing operations out of UK, Belgium, France and Germany, Gardi is also known for his knack to operate remotely, fix telecons and regular update meetings even at 6 am (London time) with teams spread across the world. Whereas Shah prefers to have face-to-face interactions and meetings. â€œThough I would like to learn from Binoy how to work remotely. However, globally, I'm selling India which requires constant networking. At the end of the day, Binoy and I, recognize each other's intentions,â€?confesses Shah. Humble beginnings It was sheer power of an article which gave rise to the conception of the company. The story goes that Shah read an article on the Indian clinical research industry which was slated to be the next sunrise industry after IT. At that time, Gardi and Shah were working together for the family trust hospital. In addition to this, Shah had a packaging business which was â€œnot so excitingâ€?. â€œI realized that I needed to do something better in life and that is how the idea came up. Both Binoy and I started working on the business plan but we needed to attract the right kind of people. We then realized that working in central India will not do,â€? reminisces Shah. Initially, Veeda was managed as part of the family trust but they soon realized that it had to be run as a different entity altogether. Recalls Gardi, â€œIn the beginning, we just had an idea and a vision. We didn't even have a building nor any land to start the venture. The key to success was also to attract the right kind of people and retain them.â€? From day one, the strategy was to work on an international platform instead of being India-centric and specialize only in phase I early clinical development. â€œWe looked at our competitors and observed that they were trying to do everything. We wanted to be different from the very beginning,â€? adds Gardi. India around that time became TRIPS compliant which ushered in the age of product patents. This opened up large avenues for clinical research space, quality scientists and research coming out of India. When Veeda came into existence in 2005, teams of five and six were sent to the UK unit for training purposes. The advantage was that both understood western as well as the Indian psyche with Gardi being brought up in London and Shah having studied in the US for two years. Thus a culmination of all these points â€“ to be different, going niche, to compete on the international scale, having the knack to adapt to different cultural backgrounds and focusing on the right team went ahead in creating the winning strategy for the team. Odyssey so far Since 2005, it has been a journey of quick acquisitions of phase I CRO units across the globe. Today, Veeda has made four CRO acquisitions in Europe, has set up pharmacology units in India and the UK (Plymouth) and a biometrics team in Brussels, Belgium. In January 2007, it completed the acquisition of DICE, a Brussels-based CRO unit, subsequently, it forged a deal with Shanghai-based Novamed in May 2007. In the same month, it completed its acquisition of the phase I units at Gorlitz, Germany thus adding to its existing European units in UK and Belgium. In the same year, it also announced plans for four more acquisitions within four months with an additional investment of Rs 100 crore for expansion of its facilities and acquisitions. Despite being termed as an acquisitive company, it was not a cakewalk for the team. â€œIt is difficult to look out for an acquisition because more than the financial aspect it is looking for the right kind of people. This is a people's business and surprisingly most of our acquisitions happened from our relationship building exercise with clients across the globe,â€? adds Gardi. With success in the European market, the only market left to complete the jigsaw puzzle was the US. The company at the moment is scouting for potential phase I units to buyout and the process has been going on for the past 18 months. It was almost on the verge of acquiring a unit but the plan was kept on hold due to unrealistic valuations. â€œUS is a difficult market when it comes to looking out for CROs because we are on the look out for phase I units which specialize in NCEs,â€? adds Gardi. With the US plans kept on hold, the company then put on its thinking caps for its next level to growth and this gave birth to its subsidiary Veeda Oncology which looks into late phase trials for oncology. This subsidiary today has operations across India, West Europe, Eastern Europe and the US. Why just oncology and not a basket of therapeutic segments? Clarifies Shah, â€œToday, if I have a team of 60 people competing with a larger CRO having 200 people, I will still be a stronger team because I have all the 60 people working on oncology while out of 200, they have just 20 people in oncology.â€? Veeda has recently spread its wings to South East Asia with a collaboration with the Malaysian ministry of health for setting up of phase I and early clinical development unit at Kuala Lumpur. Apart from this, it has various laurels to its credit. Veeda was awarded the Supplementary Accreditation for conducting clinical pharmacology phase I trials in Europe by the Medicines and Healthcare products Regulatory Agency (MHRA), was awarded $10.2 million of new clinical research programs in December 2008 from five new clients and made the acquisition of the US based International Oncology Network (ION) Clinical Research last year. The acquisition of ION Clinical Research provided Veeda with immediate access to the 50 ION sites that conduct oncology clinical research in the US. What the team thinks? Both are excellent human beings and not just leaders. Both are professional and open to ideas. They give us the freedom to put in our ideas which does not happen in many companies in India. While Apurva is more of a financial person, Binoy is more on the business development side. Both have the eye and vision to foresee exactly the kind of business they would like to enter. -Dr Kiran Marthak, member, Board of Directors of Veeda Clinical Research Binoy and Apurva like to look at things differently. They have the caliber and will to translate a vision into reality. They have created a company wherein people are allowed to think differently and creatively. Binoy is a more systems driven person and has the courage to move forward, whereas Apurva is extremely considerate and humble person which has contributed to Veeda's growth. He has good people management skills. -Rajendra Prasad, VP, business development, Veeda Clinical Research Industry Speak Veeda has a unique and focused strategy, which is cut above the rest. They have a major focus on oncology which is an upcoming niche segment. It is a far thinking CRO. In a few years time, it will emerge as one of the top CROs in India. -Joseph Manoj Victor, Frost & Sullivan Healthcare November 2005: Veeda Clinical Research comes into existence. January 2007: Completes the acquisition of DICE, a CRO based in Brussels, Belgium. May 2007: Forges relationship with Novamed, China. May 2007: Completes the take-over of a phase I clinical research unit in Gorlitz, Germany. June 2007: Frost & Sullivan presents Veeda Clinical Research with the Partner of Choice Award 2007 for phase I studies. November 2007: Passes 3 international audits in less than 90 days. January 2008: Installs India's first ever clinical Pharmacology Unit for renal impaired patients. March 2008: Launches New Global Oncology CRO Subsidiary. July 2009: Announces the Opening of a New Unit in SE Asia. August 2009: Veeda UK awarded the MHRA Phase I Supplementary Accreditation. People's men Veeda's success story can be attributed to Shah and Gardi's people management skills. Gardi and Shah believe that it is a professionally run business rather than a family run enterprise and communicate so to the employees. They are self confessed family oriented men; they see to it that their hectic work schedules doesn't affect their normal family routine. They agree that there can be no perfect balance between work and family. The duo also sees to it that they provide the same flexibility to their workers. There is no full stop for these two entrepreneurs. They have set ambitious but realistic targets for Veeda in the coming years-to touch a revenue of over Rs 300 crore and to be among the top three Indian CROs in another three years. The core team has a business plan which might include an acquisition of a unit(s) in the US. But the game plan remains the same-to be focused and a cut above the rest. This apart, philanthropy is one area where the duo likes to dedicate a considerable amount of time. Nayantara Som in Mumbai ]]> <![CDATA[He gave the Science of Sight a human face]]> https://biospectrumindia.com/news/95/3571/he-gave-the-science-of-sight-a-human-face.html https://biospectrumindia.com/news/95/3571/he-gave-the-science-of-sight-a-human-face.html Tue, 12 Jan 2010 18:23:00 +0530 He gave the Science of Sight a human face Fondly known as Prof. Bala, he has taken his place among the best researchers in India today. Prof. D Balasubramanian’s most famous accomplishment was the description of the molecular and cellular approaches to treat diseases of the eye, however, he has another facet that is not so well-known. It is his contribution to popularizing science. Born in pre-Independent India, this 70-year old incredibly energetic “young man” has over three decades of work behind him—right from chemistry to spectroscopy to biophysical to proteins and true biology he can be labeled as ‘the experienced’. BioSpectrum honors Prof. Balasubramanian, Director, Research, L V Prasad Eye Institute, Hyderabad with Life Time Achievement Award 2009 for his significant fundamental contributions to translational biology through both single scientific discovery and body of work. His contributions, be it in research, leadership, or mentorship, have had a lasting impact on the biochemical research field and, have demonstrated a lifetime commitment to the progress and popularization of modern biology. Trained as a biophysical chemist at the doctoral level, Prof. Balasubramanian initially worked on the structure and function of proteins and polypeptides. His early research focused on the spectroscopic analysis of the conformations of these molecules and the thermodynamic analysis of their stability. It was only in 1984 when he turned his full attention to eye research—to the proteins of the eye, specifically the crystallines of the lens and their role in keeping the eye lens transparent. He showed how photochemical damage to these proteins compromises lenticular transparency and leads to cataract. More recently, his group has vigorously pursued the field of adult stem cell biology. With the discovery of adult stem cells in the limbus, surrounding the cornea of the eye, they have isolated these stem cells, cultured them on human amniotic membrane to produce transparent, stitchable corneal epithelia. These have been successfully transplanted in over 700 patients. Early career in science Born on August 28, 1939 in Tamil Nadu, Prof. Bala completed his SSLC (Grade X) at the age of 13, but during that time, the Indian universities were not admitting students below the age of 15. It was only with the help of his uncle, who was then the principal at Birla College (the person who later created BITS, Pilani), that he could complete his intermediate from Pilani in Rajasthan. His professional career in science started as a lecturer at IIT Kanpur, and from there, he moved on to become the Dean of University of Hyderabad followed by becoming the director of CCMB and finally settling as the director of research at LVPEI in Hyderabad. Prof. Bala started his life as a chemist. He did his PhD in physical chemistry with a great deal of implications in biology, and in particular, protein chemistry. After completing bio physical chemistry, Prof Bala did post doctoral work in the US on certain aspects of protein structure. He then came back to India in 1967 and joined the chemistry department of IIT Kanpur to teach not only physical chemistry and spectroscopy but also the frontier topics in biology, which was very new at that time. After rendering his selfless service at IIT Kanpur for 10 years, he was later enticed by Dr Gurbaksh Singh, former vice-chancellor of the University of Hyderabad to join the university in 1977. He left IIT and played a significant role along with Dr Gurbaksh Singh in building the University of Hyderabad. Recalls Prof. Bala, “There were months, week after week, when Dr Gurbaksh Singh and I would take the morning flight to Delhi, arrange for finances, get clearance for equipments and take the evening flight back and, not even eat. That was the kind of dedication we had. And there was the excitement of building a campus on 2,200 acres and to build one building after another.” Prof. Bala’s actual move from education to research happened only in 1982 when Dr P M Bhargava approached him to join the Center of Cellular and Molecular Biology (CCMB). It was his sincerity that he did not leave the university immediately rather worked for both the institutes for about two years. And once the CCMB became more official, he resigned from the University of Hyderabad to join CCMB. Shares Dr Bala, “That was a very exciting period as modern biology had just got into India. Molecular biology and cell biology became the new mantra through which you can understand the living functions of different organisms. Immunology had also just got started. So quite a lot of our work in CCMB had to do with the basic understanding and aspects of biology.” As India opened, its economy to the world in 1992 opening a gateway of opportunities in science and technology, innovation and research, CCMB under his directorship and capabilities in modern biology was all set to take advantage of it. Introduction to eye research Prof. Bala’s first encounter with true biotechnology happened only in 1992 when Shantha Biotechnics approached him with a small DNA-based molecule called Hepatitis B antigen to make a vaccine against the disease. Prof Bala played a key role in setting up an incubator for Shantha inside the CCMB, appointed an in-charge for the project. In appreciation Shantha decided to pay CCMB royalty every year and continues to do so. The center has so far collected half-a-million dollars from the company. This, Prof. Bala believes, was a remarkable collaboration that happened. “Ours was one of the earliest such partnerships,” he claims. Much of Prof. Bala’s work at CCMB had to do with proteins and lens of the eye. At this time Dr Gulapally Nageshwara Rao started the non profit and non-government institute called L V Prasad Eye Hospital with funds from the popular film-maker L V Prasad. Prof. Bala’s interest in the study of eye diseases led him to form a connection between the LV Prasad Eye Institute and CCMB in 1987, followed by successfully setting up a lab at the hospital. After working for almost 10 years at CCMB, the enthusiast researcher had fully developed his eye research. His interests towards translational biology forced him to take an early retirement from CCMB in 1998 at the of 58, and join the LV Prasad Eye Institute. Prof. Bala says, “It was in 1999, we actually saw that the eye has a kind of cells that we now know as stem cells. And if you take them from the eye you can culture them in the laboratory to produce the corneal sheet. We realized that we can possibly do something using this technology for people with damaged eyes. We made this possible at L V Prasad Eye Institute with Dr Sanghwan and Prof Geetha. We got our first funding for this remarkably new technology in 1999 from DBT.” Popularizing science Unlike other researchers, this science child believes in popularizing science and making it accessible to as many people as possible. He has been promoting modern biology and adult stem cell technology in India and worldwide. “If the philosophy of science wants to pass along its views adequately to the public, it is important that the latter have a basic general understanding of science. Only in this way, popularization of science can be meaningful from a philosophical and educational point of view. Scientists have to take the responsibility and be honest in their efforts, both toward science as well as the public,” believes Prof. Bala. This academician turned researcher is also a columnist, and has over 170 scientific publications in leading journals. Recipient of several national and international awards including the Padma Shri and Chevalier de l’Ordre National de Merite, a national honor given by the French president, Prof. Bala is also the president of the Indian Academy of Sciences. His philosophy is to be the first one to do it and if not, then be the first one to propagate it. Happily married to Shakti, a former television producer, the couple is blessed with two daughters Katyayani and Akhila. Katyayani is a research analyst, and Akhila works with Amgen in the US. Industry Speak Dr Balasubramanian is known to me for the last 25 years since 1994. I personally owe a great deal to him for accommodating our Shantha Bio-Scientific team of nine to work in CCMB labs for almost one year until our own facilities came up in 1995. His acceptance of a start-up company like ours to work in such a prestigious institute is an example of his great vision and keen interest in promoting the first Bio-pharma venture in India. The much needed scientific ambience to our scientists’ team was provided through his kind gesture to work in CCMB as our incubation centre. Hence, Shantha and its entire team along with me would be ever grateful to his initial help. Apart from his science capabilities (I am not a scientist and hence cannot talk much about it), I realized that he has great bent of mind on literature and music that is what has brought me close to him. His many articles on science are like sweet poems. I still remember that in one of his articles in The Hindu, he made a mention of Shantha’s Hepatitis-B vaccine which was being supplied to Pakistan, he coined a beautiful phrase “Our vaccine is a missile of Peace”. His interest in science application has made him to join L V Prasad Institute to address the avoidable blindness of many in the country. He is a man with great scientific temper and he has science with human face. He also has the ability to express the science poetically. I close this small note with a sense of great gratitude to him for his help in the initial days of Shantha. —Varaprasad Reddy, MD, Shantha Biotechnics He was one of the first two senior scientists that I had employed when I had agreed to set up the Center for Cellular and Molecular Biology in the late 1970s. Dr Balasubramanian is a very good scientist and an excellent communicator. He has certainly made significant contributions to molecular biophysics. One of these contributions that I remember was on understanding the mechanism of development of resistance to chloroquine, the anti-malarial drug. This work, if I recall, was published in Science. —Dr Pushpa M Bhargava, Supreme Court observer to GEAC Jahanara Parveen in Hyderabad ]]> <![CDATA[Leveraging the India-edge]]> https://biospectrumindia.com/news/95/7294/leveraging-the-india-edge.html https://biospectrumindia.com/news/95/7294/leveraging-the-india-edge.html Tue, 12 Jan 2010 18:12:00 +0530 Leveraging the India-edge Two is company. That’s how it started for Hari Shankar Bhartia, who after completing his degree in chemical engineering in 1979, joined hands with elder brother Shyam to build the Jubilant Group. Originally incorporated as Vam Organic Chemicals in 1978, the company has evolved into its current form, Jubilant Organosys. From surviving and growing in the license raj to riding liberalization—it has traversed a great distance and today the Jubilant group has interests as diverse as life sciences, energy, retail and food service. Supported by their father, in 1972, Shyam had conceived the project to build a chemicals company that used feedstock as raw material and located the manufacturing facility in Gajraula, Uttar Pradesh, in close proximity to sugar mills for easy availability of molasses. The company was making an intermediate called pyridine, a lot of which went into the pharma industry. This facility and pyridine went on to become the backbone of the company with pyridine chemistry platform as its major focus. In all drugs, at least 20 percent of intermediates come from pyridine or its derivatives. The company, then known as Vam Organics ranked 7th globally in pyridine production. When India started opening up in the 1980s, the Bhartia-brothers decided to tap the global markets. They started scaling up the research and development team. The company was building its own pyridine chemistry research platform, which ultimately helped it become the lowest cost producer of pyridine. Subsequently, it went on to become and still is the world’s No 1 producer of pyridine and its derivatives with 35-40 percent of global market share. Business transformation fast-tracks growth Today, the company has built a strong, sustainable business model through consistent organic growth and inorganic expansion by acquiring niche businesses in developed markets like Canada, Europe and the US, and has more than 60 percent of its revenue coming from international markets. “Jubilant has reported this robust growth due to its strategic thrust on moving up the value chain in pharmaceuticals and life sciences products and services,” says Hari Bhartia. He is now devoting 100 percent of his time to life sciences. The segment is the fastest growing business for the company and currently accounts for three-fourths of the group’s topline. Often referred to as a great visionary by his core team, Bhartia had visualized the growth trajectory and consciously chose life sciences segment as the growth engine. The business transformation journey from pyridine to APIs (active pharmaceutical ingredients), dosage forms, injectables and drug discovery and development was all mapped out much ahead and it came to fruition. With the basic chemistry strength in view, he went about building technology and capability around it. “We knew which way the industry was moving,” he says. The pace of growth stepped up after the new business identity Jubilant Organosys, the “science active” company came into existence in 2001. The strategy was to build an integrated platform to service the pharmaceuticals industry. In the last seven years, Jubilant has seen explosive growth, aided both by organic as well as inorganic measures. “We really entered the life sciences business only in the year 2000, and are actually a very young company,” states Bhartia. It was only after defining the company as “science active” that Bhartia started moving away from the chemical part of the business. What followed was the journey to drug discovery platform integrating capabilities like structure-based drug design, bioinformatics, medicinal chemistry, and clinical among others. In just about five years he created the integrated drug discovery platform. “We started on it about five years back and today we have one of the country’s largest integrated drug discovery platform,” he says. This is the shortest time frame any company in India has achieved this scale and capability. The objective for the next two years is to grow this platform. “Now, it is about scaling up the assets that have been created. If there is a technology or competency gap that comes up we will acquire but we are not looking at large acquisitions at this point,” explains Bhartia. Essentially, Jubilant is focused on building scale and introducing new products. For example, large part of the business, which is APIs, is growing at a healthy rate. “In APIs, we will continue to add seven to 10 products to the portfolio every year,” says Bhartia. “In some businesses, we are No. 3 or 4. There we would strive to get to No, 1 and start to take leadership in finding offshoots of these businesses,” he adds. The transformation so far has been a challenge and is by no means complete, according to Bhartia. He has lot more on agenda. The life sciences business is the only business where both the Bhartia-brothers hold executive positions vis-a-vis rest of the businesses which are board-managed by Bhartias. The fact that the opportunities in the life sciences space are huge eggs him on. Even though the Jubilant group is likely to close the current year with a flat growth the company is on a strong footing and is consolidating. Besides, there is no slowdown in the CRAMS business, its mainstay. The life sciences business, overall, is expected to record a growth, of 14 percent. “Besides, as capacity utilization improve the margins will go up and the order book is also encouraging,” he says. Innovation ecosystem agenda Bhartia envisaged and worked about this transformation because he saw the opportunities that were waiting to be tapped. He put in place a system to provide research services to the global pharmaceuticals industry. “We said we can help you innovate,” he says. The complexion of the industry is changing. Big pharma companies don’t know it all. They cannot do it all. They cannot do it all by themselves. There are far too many pressures. In the backdrop of changing business models, according to Bhartia, companies like Jubilant can play a growing role. The context for innovation is taking roots in the country. For innovation, there must be competition. In India, competition came in existence only in the mid-90s. A step-up in the partnerships and collaborations is what we will see in the near future. “In another four-five years you will see the change. Now, its just a matter of time,” he says. In the last decade, the life sciences industry has seen two turning points. One, the industry graduated from selling to the domestic pharma market to becoming a generics supplier to the world. Complying with FDA requirement to sell in the regulated markets will now begin to have a rub-off effect in domestic manufacturing. That was the first level of globalization. Second turning point, which is a recent development, is the realization and the success stories that we can do research not just in generics but in innovative products as well. The ecosystem of innovation has begun to evolve. “In about five years of time frame you will hear stories of academics who start companies to commercialize their research and become successful,” he says. However, this is not to say that all this will happen without any push from the government. Early stage science has to be supported by grants and the government in India is doing it. There are some very good initiatives that have been put in place by Department of Biotechnology under Dr MK Bhan’s leadership. “We need to seduce people to science early. It is best done at academia level. For this, we require huge investment in laboratories. This is beginning to happen,” opines Bhartia. Leading from the front Bhartia champions innovation not just in his company but on a wider platform as well. He led the high-powered Confederation of Indian Industry (CII) business delegation, as the organization’s vice-president, to the US, accompanying Prime Minister Manmohan Singh. The objective of this 30-member mission was to strengthen the bilateral economic relations between the two countries and forge collaborations on global challenges. In his capacity of the vice-president at CII, he is keen to do as much as possible to remove bottlenecks to growth. The current year CII agenda has been focused on bringing industry back on growth track. And it will be back to normal by the last quarter of the year, except the export side which will remain dependent on the global economy. The focus for 2010-11 is on skill development, affirmative action and innovation. The government has already formed the national skill development board, and CII will help the government decide curriculum and the strategy that will help bridge the gap and make the human resource passing out of colleges more employable. “CII handles a wide range of issues: there is one on how to make industry friendly towards issues of climate change and so on,” says Bhartia adding that the idea is to build a strategy and system that includes all the companies, and results in the industry voluntarily taking actions which are inclusive. Any economy has three stages of competitiveness—one, factor driven; two, scale driven; and finally, innovation driven. It is this power of innovation that should be harnessed. Currently, Bhartia himself is innovating in the healthcare delivery space by taking up the challenge of delivering affordable healthcare to middle and lower income group living in the villages and districts of West Bengal. Jubilant First Trust Healthcare Limited under the brand of Jubilant Kalpataru Hospital, is in the process of setting up an integrated network of hub-and-spoke hospitals in the state. The company will create a total capacity of 1,000 beds across seven hospitals and two nursing schools/colleges to supply qualified and trained support services to the specialists at the hospital. This pilot project’s hub is located in Howarh and it covers a radius of 250 km. What the team thinks? Hari’s vision and deep-rooted understanding of science is exemplary. His approach and commitment to research has made a significant contribution in putting Jubilant on the growth path. Under his leadership, we have consolidated the drug discovery platform across multiple subsidiaries and today have an integrated service offering for the market. —Sri Mosur, CEO & president, Global Drug Discovery & Development, Jubilant Biosys I have known Hari for over seven years now and the most outstanding aspect about him is his true belief in innovation and research. He has been instrumental in many collaborations to forward the cause of science. When I met him in 2002, the group was not into pharma business but I saw their passion and commitment to get into this sector, which convinced me into joining the Jubilant group. There has been no looking back since. —Jag Mohan Khanna, Executive Director, Science & Technology, Jubilant Organosys Ltd It is almost a decade back that I met Hari Shankar Bhartia. He was kind enough to meet me and discuss on several weekends setting-up Jubilant Biosys. I had the pleasure of interacting with a professional who is the visionary with extraordinary commitment and patience. I saw in him a person who treats all employees and stakeholders with great human touch and respects their individuality. It is a pleasure to be associated with such a great human being. —Dr V N Balaji, Chief Scientific Mentor, Jubilant Biosys I have seen him not only as a strategic and a visionary leader but also as a person who has passion for science and innovation. With multiple and diversified businesses within Jubilant portfolio and also considering his chemical engineering background, it is amazing to see his understanding of the complexities of drug discovery and development. I have always seen him as a leader who is socially oriented, is flexible and is a great visionary. —Dr Surinder Kher, Senior VP, Vanthys Pharmaceutical Development Key achievements in 2009 Jubilant entered into a joint venture with US-based Eli Lilly to focus on drug development. Jubilant Biosys, a wholly owned subsidiary of Jubilant pioneered the concept of collaborations by announcing several drug discovery partnerships with global pharmaceuticals majors, such as Amgen, AstraZeneca, Eli Lilly, Endo Pharma, Forest Labs and Orion. The focus on developing innovative technologies gained momentum and the company designed and developed a technology for 4-DMAP and successfully commercialized the product. Jubilant is the only company in India to make this product, the only other countries where this is manufactured are the US and China. Jubilant’s new state-of-the-art dosage forms facility at Roorkee received approvals from UK MHRA, the health regulatory body. Jubilant successfully integrated the sterile injectable business in North America that enabled the company to capitalize on the synergies achieved and signed three large size contracts with leading global pharma companies, despite the global slowdown. Life et al So, while he keeps so much going. What keeps him going? Family time, every Sunday; family holidays twice a year; quiet times spent all by himself—reflecting, assimilating experiences and learning; and a wide variety of reading coupled with travel. Keeping an open mind is essential, he believes. That is “the one” critical element which helps broaden horizon. He credits most of his learning and influences to travel and visiting labs and companies across the world and observing how other people do things. While he became more and more focused on work since 1979 his other interests fell wayside. Polo, film-making, lawn tennis in that order are no longer part of his routine. Not even golf. He didn’t take to it. There is so much to do and so little time. He works all Saturdays and devotes at least four hours a week to CII and industry matters. Making a difference to the industry is on his agenda now. Another challenge is being met head-on by the quiet, unassuming Bhartia. Nandita Singh in New Delhi ]]> <![CDATA["Piramal Diagnostics to focus on large cities"]]> https://biospectrumindia.com/news/95/2694/piramal-diagnostics-to-focus-on-large-cities.html https://biospectrumindia.com/news/95/2694/piramal-diagnostics-to-focus-on-large-cities.html Thu, 17 Dec 2009 20:32:00 +0530 â€œPiramal Diagnostics to focus on large citiesâ€? In a tete-a-tete with BioSpectrum, Girish Mehta, president and CEO, Piramal Diagnostics Services, a Piramal Group company, gives a comprehensive picture of the company's achievements, its growth chart and future plans Looking back over the past one year, what do you think have been some of the landmark achievements of the company? Our growth has been stupendous over the past two years and further consolidated our position last year. We clocked a turnover of Rs 200 crore plus last year and today we have 100 plus centers which include metros, smaller metros and even the remotest of towns. Now that we have covered A class, B class and C class cities, we are actively pursuing franchisee spread, where some of the D class cities will also be covered. The areas we have covered, has tremendous growth potential. In Gujarat, we are in five cities; the recent one being Vapi. Though we are not in the peninsula of Gujarat, we think it is a promising state, with conducive support from the government and some very entrepreneurial people. In 2003, we had just three scientists and now, in 2009, we have 104 scientists, an increase of 101 in six years time is a sharp increase. We have a strong presence in north, south and west India. In the east, we are strong in Kolkata and Assam. However, there have been few states like Bihar and Jharkhand, where we have deliberately not gone because of the law and order situation. Also it was difficult to find the right kind of people to tie-up with. However, this does not mean that we do not cover those areas; we have our collection centers over there. Today, we have around 350 collection centers across the country covering remote areas. We also have 300 doctors, highly trained pathologists and radiologists. We constantly rotate our people across the country for better training exposure to better machines systems procedures. Since its inception, Piramal Diagnostics has been following a hub and spoke model. Can you throw some light on that? Yes, we do follow a hub and spoke model. We have hubs in Mumbai, Delhi, Chennai, Hyderabad and Kolkata. For example, in the west, some of the high testing is done in Mumbai. But, we have established a specific service sections only for receiving the samples, redistributing them, recollecting the reports and sending the reports. Our model is to tie-up with existing centers across the country wherein the financial stake is almost fully-owned by us. Thereafter, we help in the growth of that center and equip it with all our high-end systems and equipments as well as procedures. However, we are very choosy about the tie-ups we enter. On an average, we get two proposals per day for such tie-ups but then, we join hands only with the best of the lot. Given our kind of model and the geographical expanse of our centers, there comes a lot of complexities, but we have taken it as our goal to consolidate that position and bring about uniformity in systems and procedures across all our centers. Given the geographical expanse of your centers in India, is there any difference in pricing between A class and C class cities? No. There is minimal difference in the prices which we have to offer. The pricing is not dependent on the city size, the population or the type of people present there. It is dependent on the past legacy of the city in terms of spending power of the people. What are the steps Piramal Diagnostics is taking towards quality measures and high-end technological infrastructure? We spend a lot of money to maintain quality standards. For example, we have an accreditation by College of American Pathologists. To maintain this accreditation, we spend almost Rs 20-25 lakh-a-year because we constantly send in samples and tests and see whether our quality standards is in line with their norms, where the competition is lesser. Technologically, we have got the entire high-end technological infrastructure both at the radiology and pathology centers. But instruments alone do not make a lab technologically viable. You need to connect them with IT, which we have done with our own IT system, APEX+. It links the diverse set of high-end equipment and makes everything automated. Human intervention is minimal which means the chances of error are also minimal. With this system in place, electronic transfer of reports and images are made possible. We have invested almost Rs 10 crore into it both for hardware and software, as it needs to be constantly upgraded. Similarly, we have 64 slide CT machine for heart diseases which can tell you what kind of blockages are there in the arteries without an invasive treatment Is there any kind of campaign that the company is undertaking? We want to create awareness and at present we are working on certain mechanisms. We are also an active part of a campaign which is initiated by our own group. But to create this kind of awareness across the country, huge amount of resources are needed, and these needs have to be addressed. The team at Piramal is working on this. What have been some of the challenges for the company? From the very beginning, we are following the acquiring and integrating model. Bringing the best people on board and telling them that they have a future with us was a challenge. Once that was addressed then to integrate them to our culture was a challenge, which we have been overcoming on a continuous cycle. From a diverse set of acquisitions, today we have a unified piece, which is not only growing in scale but also in size. Can you enumerate some of the diagnostic trends in India? The growth of diagnostic market has been secular and in the next eight to 10 years, the growth will be anywhere between 10 to 12 percent. The fundamental reason being that the population is growing at a rate of over 10 million per year. The second reason is that the affordability for medical diagnostics and medical services is growing. Despite the slowdown, the Indian economy is not doing very badly, instead of the 9 percent growth, we are growing at 6 percent while other countries are growing at two percent. Also, the rural economy has been doing well with the various government schemes, and agriculture is flourishing. Due to these factors, people have cash in hand and hence, the medical tests which should have been done earlier, are happening now. The third thing is that the legal and statutory scenario in medical diagnostics is improving. Use of diagnostics as a treatment is a trend among new doctors. Like in the west, 70 percent of all treatments are done through diagnostic testing. Health insurance is growing in the last few years. What are your future plans? We have lots of targets this year for acquisitions as well as growth and if everything goes well, there should not be any reason why we would not cross a turnover of Rs 250 crore. During the downturn, there was no slowdown of investment. But we realized that we have grown very fast and that our systems have been left behind. It is important because as a geographically diverse company, we need to have our systems in place and we are in the business of serving people. We need to improve ourselves to keep in line with what the market expects from us. Between 2005 and 2008, we were acquiring two centers a month. We are starting a second franchisee center in Raipur and then in Meerut. Focus is now on the larger cities. Nayantara Som, Mumbai ]]> <![CDATA[PDP to expand India presence]]> https://biospectrumindia.com/news/95/5405/pdp-to-expand-india-presence.html https://biospectrumindia.com/news/95/5405/pdp-to-expand-india-presence.html Thu, 17 Dec 2009 20:30:00 +0530 PDP to expand India presence PDP Life Science Logistics India, a part of the conglomerate, PDP Couriers, UK, caters to the specific logistic needs of the clinical trials, pharmaceutical, biotechnology and healthcare markets. In addition to shipment capabilities, PDP provides global service for the supply of cold chain clinical trials supplies, diagnostic specimens and finished products. In an interview with BioSpectrum, Nick Butcher, executive chairman and Clive Bryant, director of sales and marketing, of PDP Life Science Logistics India, reveal PDP’s plans in India and the enormous opportunities India and China hold for the company. How favorable is the Asian market for PDP’s business plans? Clive Bryant: There is a rising trend in pharma and biotech companies to conduct their research work in emerging countries like India and China. The emerging markets have been growing stronger and financial spending for clinical trials by global pharma companies are restricted to these regions today. In countries like India, these companies are looking at specific set of patients. In order to support this they are looking for companies with strong logistic capabilities, and specialist couriers who can provide unique packaging for sensitive equipments used in clinical trials and for high speed delivery to remote regions in the country, specially in the background of diverse temperature and climatic conditions. Nick Butcher: PDP came into being in July 2007, and since then, we have expanded significantly across the globe by establishing ourselves in India, Singapore, Australia, China and shortly we will be looking at Japan. We expanded in order to meet the needs of global customers. Our focus has always been clinical trials, pharmaceutical and healthcare markets. In these emerging markets there has been awareness and global understanding of the need for quality logistic systems and software. However, there are many challenges in these countries that is why companies like us have been investing heavily to support clinical trial processes. What were the Indian market opportunities for PDP in 2007? Nick Butcher: The market in India is focused on a variety of patients to conduct clinical trials. We believe that India and China are going to see significant growth in terms of clinical trials. Already the growth is happening. The pharmaceutical industry here is growing very strongly and the demand for drugs in these two countries is rising. As people become more wealthy, demand for drugs will rapidly increase and the support for clinical trials will grow dramatically. This is where PDP has a critical role to play by supporting the demand in these two countries. Elaborate on the systems and softwares that PDP offers to the life sciences industry? Nick Butcher: PDP has developed its own operating system which we use throughout the world. We have our own tracking devices and online booking systems. We differentiate ourself from other companies by providing more than just technology. We offer high-end technology systems, including tracking and tracing devices, to the advantage and benefits of our customers. Clive Bryant: We are investing in tracking systems which is expected to link us with the customers and their processing system needs. With the help of tracking and tracing process, we will understand what is happening at each level and stage of a particular clinical trial project. What kind of investments is made by PDP in India? Nick Butcher: In India, we invested in establishing offices in Bangalore, Mumbai and Pune. We are shortly opening offices in Hyderabad, Ahmedabad and New Delhi. We want to establish our presence in all the metros so that we can touch base with as many customers as possible. In the second phase, we are looking at Kolkata and Chennai. Lastly in the third phase, we would like to move into tier II cities. Does PDP have any specialist team for logistics and packaging solutions? Clive Bryant: We have a specialist packaging team in UK for transferring knowledge to the Indian business. In UK, we have development teams, which comprises experts in packaging solutions and, their knowledge will be advanced through the support from our head office. Are there any plans to set up a similar specialist team in India? Nick Butcher: As of now, we are in the establishment and growth phase. As business grows in India, which should be complete in December 2009, PDP India will be a fully-functional business. Once it reached that stage, we will be looking at logistics and packaging solutions and the strategy to grow our business in India. Could you compare the growth prospects in India and China? Clive Bryant: India and China pose very similar and critical challenges as far as clinical trials and supply chain are concerned. At this point of time, both countries lack a strong infrastructure that allows a speedy transit, both countries have climatic challenges, which are similar—high temperatures to very low temperatures, and individual’s lack of understanding of the complexity of the business and the passion to realize that this business involves the transportation of highly time-sensitive products. Both are difficult markets and have a regulatory framework which is stringent as compared to the markets like UK. However on positive lines, both countries are investing heavily in infrastructure and healthcare. The growth is significant and the demand for modern medicine is very sharp. Drug discovery companies are now tailoring drugs that are suitable for this population/ market and also conduct clinical trials, which are the positive signs for growth opportunity. Could you elaborate on PDP’s customized logistics solutions? Clive Bryant: We spend time with our customers before any shipment is made, and chalk out logistics plan for any study. For a customer who is based in India, we study and discuss about their plans to deploy their studies across India through all the stages of the clinical trials. We understand their packaging requirements and tailor-made logistics table to meet that requirements at the metro level, sub-metro level, and tiers II and III levels. This consultation with the customers at every stage of the clinical trial study, we come up with right packaging, refrigerating and delivery services. What are the steps taken for quality assurance? Clive Bryant: Quality is paramount to us. We follow defined good manufacturing practice (GMP) standards to ensure that our programs meet the quality requirements of our customers. We have a pro quality team based out of UK. And this quality team will carry out the implementation of all the facilities. At present, we have quality teams based out of four locations in UK. What were the challenges faced by PDP when it ventured into India? Clive Bryant: The first challenge was to develop a packaging technique that is suitable for the domestic and international markets, so we looked at potential partners from whom we could learn about the packaging changes from one part of the country to another. Nick Butcher: One of the challenges when we started off in India was to get the right kind of people who could understand the processes and procedures that are critical to this industry. How did the downturn affect PDP’s business? Nick Butcher: The company was bought by our management in 2007, and since then, we have been investing heavily in new markets and territories. We have not experienced the downturn because we are new in the business. We will witness growth in the coming years. Clive Bryant: Our customer base is growing in India. They are seeking products, speed in terms of meeting the requirements and getting the products to the required destination in India or abroad, and security in terms of the fact that the products are highly sensitive and cannot be replaced. That security should also ensure protection against temperature and physical damage. In the downturn, however, everybody is looking at saving costs and are not eager to pay more for the safe and speedy services. So during this period, we have to meet our customers’ expectations at an affordable cost. Nayantara Som in Mumbai ]]> <![CDATA[Ecron Acunova strengthens EU presence]]> https://biospectrumindia.com/news/95/6726/ecron-acunova-strengthens-eu-presence.html https://biospectrumindia.com/news/95/6726/ecron-acunova-strengthens-eu-presence.html Thu, 17 Dec 2009 20:26:00 +0530 Ecron Acunova strengthens EU presence In 2009, Ecron Acunova further strengthened its Eastern European presence by launching direct operations in Russia and entered into a strategic alliance with Japanese firm, Tokyo CRO Ecron Acunova, an integrated CRO promoted by Manipal Education and Medical Group, and Acunova Life Sciences with Ecron, a German CRO, combines the strengths from two expert CROs from two different continents serving established clinical research geographies. The company provides end-to-end services for phase I-IV clinical research, including clinical trial management, clinical data management, PK/PD services and central lab. Ecron is doing the largest number of stem cell clinical trials in India. As of now, the company is progressing with five trials in stem cell area. European expansion In November this year, the company strengthened its Eastern European presence further by opening a new office in Moscow, Russia. The company maintains that through its new office in Russia, Ecron Acunova will boost its current success rate in delivering client focused services. With its strong presence and local expertise, the company manages the most challenging time, costs and quality demands of its clients in the key clinical trial markets of the region. Foray into Japanese market A few days before the entry into Russia, the company entered into a strategic alliance with one of the leading Japanese CRO, Tokyo CRO. This alliance provides global life science companies access to India, Japan and the European countries for clinical research. Commenting on the development, Prasanna, says, â€œJapan is a key market and requires specific requirements for the approval of a new drug application. Often, the opportunity to market the drug is missed due to the specificity for procedure of the approval in Japan. As a full service CRO, we have established our expertise across EU, the US and India. With the sponsors increasing their focus on drug development programs in Japan, it is imperative for us to establish our operations through experts like Tokyo CRO in the region.â€? US expansion In August 2009, Ecron Acunova signed another strategic alliance with the US-based Essential CRO. This alliance is said to provide the global life science companies with access to 18 countries in key emerging sectors for clinical research. The alliance is executed through a combination of facilities of Essential CRO in Illinois, and Ecron Acunova in New Jersey. The company's thirst for global outreach doesn't stop here. Ecron Acunova is in talks with a major pharmaceutical company from Japan to establish similar collaborations. The company is also planning for an expansion in the US. Ajeesh Anand in Bangalore ]]> <![CDATA['Remove hindrance for biodiesel's growth']]> https://biospectrumindia.com/news/95/5071/remove-hindrance-for-biodiesels-growth.html https://biospectrumindia.com/news/95/5071/remove-hindrance-for-biodiesels-growth.html Thu, 17 Dec 2009 20:24:00 +0530 Total biodiesel production capacity in India is 3,000 tonnes per day (approx.) and, all are sitting on idle capacity since they are not being able to sell the produce in the open market due to retail constraints On April 22, this year, the ministry of petroleum and natural gas issued a circular requesting the state governments to ensure that unauthorised sale and possession of biodiesel in the market is controlled. Rattled by the circular which created a kind of a roadblock towards the reduction of vehicle pollution from emissions, the Kolkata-based FMCG major Emami Group moved the city civil court in Kolkata against the petroleum ministry’s circular; and after battling for nearly seven months, the company got an injunction on the circular in mid-November. The injunction will temporarily remove obstacles to the sale of biodiesel by producers. The company also plans to approach ministry of petroleum, ministry of renewable energy and the ministry of environment for reversal of the ban. Meanwhile, the injunction by the court will allow the company to start selling biodiesel. With this, the company will restart selling fuel to Calcutta Tramsways Company (CTC). Kolkata Police have tried and approved biodiesel produced by Emami Biotech. Further, the company is also bidding tenders with the Indian Railways. The total biodiesel production capacity in India is 3,000 tonnes per day (approx.) and, all are sitting on idle capacity as it is difficult to retail them. The problem lies with the awareness and support from the vehicle makers. Director of Emami group of companies, Aditya V Agarwal, says, “ Future of biodiesel/ biofuel in other parts of the world is good, but in India, it depends on the political scenario. And presently, biodiesel is not the top priority of our political minds.” Emami Biotech, which bagged the ‘Emerging Company of the Year 2009’ award from GlobeOil this year, was set-up three years ago. Emami Biotech, part of the Rs 2,000 crore Emami Group, has a state-of-the-art 300 tonnes per day multi-feed stock biodiesel plant at Haldia, West Bengal in technical collaboration with Desmat Ballestra of Italy. Emami has invested Rs 150 crore on the biodiesel plant. The biodiesel produced at the Haldia plant conforms to stringent European Union Standard norms, the benchmark standards set by Bureau of Indian Standards and those of the American society for Testing and Materials. The biodiesel produced by Emami Biotech is also certified by SGS, Singapore. However, the journey was not as easy as it seemed. Speaking over the phone from Kolkata, Agarwal says, “Even though we went ahead and gave orders for equipments and construction of the plant, we were also liasioning with the government to get a good policy for biodiesel, and a conducive and right environment to sell biodiesel. However, we could feel that it would not come so easy and so soon. Still we went ahead with investing another Rs 100 to 125 crore for added facilities for producing 1,500 tonnes per day of edible oil-mainly from palm and soya.” Asked why the Italian technology is used, Agarwal says, “These technologies are world renowned, and our technical team was comfortable in using the technologies which gave the best yield.”   And the source for biodiesel are bioproducts of edible oil, used cooking oil, and it just needs to be plant derivative. Ethiopian Operation The commercial plantation work of biofuel crops (jatropha) and other edible and non-eidble oil seeds have already started on 1,500 acres of land in Ethopia. With an investment of Rs 400 crore in Ethiopia, Emami Biotech has taken up plantation project in the State of Oromia in Ethiopia. For this, 1,000,000 acres of land has been allotted to Emami Biotech by Oromia Investment Commission. Once complete, the project will be able to churn out 100,000 tonnes of crude biofuel/ edible oil per year. And the biofuel will be exported to India for producing biodiesel, and the edible oil produced in Ethiopia will be used for captive consumption. “The benefit will be that we will be able to supply biodiesel to the world in a better way,” says Aditya V Agarwal, director, Emami group of companies. He foresees that once the project is complete, there will be a huge business synergy between Emami Biotech’s Indian and Ethopian operations. According to Agarwal, the Ethopian project has a huge prospect for the global export market. Technologies to watch: Next generation biofuels Cellulosic ethanol Biohydrogen Bio-DME (Dimethyl Ether) Biomethanol DMF (2,5-Dimethylfuran) Hydro Thermal Upgrading (HTU) diesel Fischer-Tropsch (FT) diesel Mixed alcohols Wood diesel Biodiesel from non-food crops such as Jatropha Biofuels from switchgrass Biofuels from micro-algae Source: wikipedia In Gujarat, the company has signed a MoU with the Gujarat government for setting up an edible oil refinery. Talks are also being held to set-up similar projects either in Andhra Pradesh and Tamil Nadu. With increasing economic activity, climate change will continue to haunt human civilization. For Emami Biotech, the challenge is to protect the planet from the perils of growth. Globally, biofuels have become important as global hydrocarbon reserves deplete fast. A new report said the world is burning hydrocarbons much faster than previously thought. The report also said global petroleum reserves including natural gas will last for less than 30 years. Hydrocarbons are also a known contributors to global warming. These issues make biofuels an ideal choice as they are easily replenished and will last long enough to power our vehicles, factories and economies. India and China, along with the US are the world’s largest buyers of petroleum products. Although the US has enough crude oil in its own land, it still, along with India and China imports 90 percent of its fuel supplies from West Asia, North Africa and Venezuela. These three countries also have massive research and investments in alternative energy sources. Anjana Pradhan, Bangalore ]]> <![CDATA[BioSpectrum Awards 2009]]> https://biospectrumindia.com/news/95/2148/biospectrum-awards-2009.html https://biospectrumindia.com/news/95/2148/biospectrum-awards-2009.html Thu, 17 Dec 2009 20:19:00 +0530 December is the time for the annual BioSpectrum Awards, which were started in 2003. The awards are to recognize the exceptional contributions of the industarum-ABLE Survey of the Biotech Industryâ€?. The top ranked companies (by revenues) in each of the sectors are the winners. The BioSpectrum Biotech Industry Awards were selected by a panel of eminent people, who come from various backgrounds. The panel is empowered to nominate or introduce any special category of award. BioSpectrum Awards 2009 jury and deliberations The process started with the constitution of the panel in the first week of September 2009 and laying down the criteria for the selection of BioSpectrum Awards 2009. This was followed by the members of the jury meeting in New Delhi on October 23, 2008 for making the final choice. BioSpectrum Jury Award Winners 2009 The jury was unanimous in its choice of selecting the winners in most of the categories. The awardees of 2009 are: BioSpectrum Life Time Achievement Award 2009: Dr. D. Balasubramanian, Director of Research, LV Prasad Eye Institute BioSpectrum Person of the Year 2009: Hari Bhartia, co-chairman and managing director, Jubilant Organosys BioSpectrum Entrepreneur of 2009: Binoy Gardi and Apurva Shah of Veeda Clinical Research BioProduct of 2009: Dry Tri T-STAT Diagnostic Kit, ReaMetrix BioSpectrum Company Award winners: BioPharma Company of the Year: Serum Institute BioAgri Company of the Year: Rasi Seeds BioServices Company of the Year: Jubilant Organosys, Syngene Intl BioIndustrial Company of the Year: Novozymes South Asia BioSuppliers Company of the Year: Waters India Public Institute of the Year: Jawaharlal Nehru University Private Institute of the Year: Sastra University, Thanjavur The jury chair, Samir Brahmachari, guided the entire process of arriving at unanimous decisions and notified each winner of the selection and the winners have agreed to accept the awards. The winners of BioSpectrum Awards 2009 would be honored on December 22, 2009 at the Awards ceremony in Bangalore. ]]> <![CDATA[Honoring Biotech's Innovators]]> https://biospectrumindia.com/news/95/1969/honoring-biotechs-innovators.html https://biospectrumindia.com/news/95/1969/honoring-biotechs-innovators.html Thu, 17 Dec 2009 20:14:00 +0530 Honoring Biotech’s Innovators Six years ago, I was on the way to Hyderabad from Bangalore in an early morning flight in October, along with some colleagues from the biotech industry. We met Bala Manian, the serial entrepreneur who had returned from the US to set up ReaMetrix to use Indian expertise and develop innovative products for the world. He explained in detail how he plans to “Act locally. Think globally.” We explained to Bala the concept of BioSpectrum Industry Awards and he generously gave his inputs on making it a success. We were traveling to meet in the office of Prof. D Balasubramanian at the LV Prasad Eye Hospital who had agreed to chair the 1st BioSpectrum Industry Awards Jury. Prof. Balu, as he is widely known to the world, after the meeting talked excitedly about the experiments in his laboratory to harvest stem cells in the eyes and how they could be used to restore vision. Six years later, these two Balas have continued their innovative steps and in the process made a huge difference to the lives of hundreds of people by their innovative steps. And these two Balas will be coming together under the BioSpectrum aegis as they both figure in the 2009 BioSpectrum Awards list, unanimously chosen by the 7th BioSpectrum Awards Jury headed by Prof Samir K Brahmachari, Director-General, CSIR. Prof Balu’s insights and knowledge in 2003 help BioSpectrum to launch the awards program by choosing the first set of truly outstanding personalities like Dr M S Swaminathan, Dr Kiran Mazumdar-Shaw and Dr Krishna Ella in the first year. Now Prof. Balu will be honored with the “BioSpectrum Life Time Achievement Award 2009” for the outstanding influence he has exercised on the Indian biotechnology sector in a variety of ways. Whether it was in laying the foundation for the growth of University of Hyderabad which today has one of the country’s finest life sciences school or in consolidating the success of CCMB after taking over from Dr P M Bhargava or in playing the pivotal role in incubating India’s first fully plain biotech company, Shantha Biotechnics, Prof. Balu has left his strong impressions on the world. And by restoring the sight to over 700 people, the L V Prasad Eye Institute is setting another milestone in the annals of healthcare under his leadership.   Bala Manian’s ReaMetrix, started in Bangalore, has lived up to the founder’s visionary expectation. The jury’s decision to give the “BioSpectrum BioProduct of 2009” to Dry Tri-T STAT, a novel enzyme which plays a key role in HIV detection and management is a product for the masses. The world’s first US FDA approved product, available in a dry form, could replace the currently widely used liquid-based alternatives in HIV detection kits which make them dependent on expensive and complex cold chain network. The ReaMetrix product will drastically reduce the cost of HIV tests and increase the reach of technology to the people who need it most. There are two other outstanding winners of the other two BioSpectrum awards in 2009. The quiet, unassuming Hari S Bhartia, co-chairman of Jubilant Organosys is the “BioSpectrum Person of the Year 2009”. And the brothers-in-business duo of Apruva Shah and Binoy Gardi, co founders of Ahmedabad-based but globally visible Veeda Clinical Research are the joint-winners of the “BioSpectrum Entrepreneur of the Year 2009”. Back in 2004, over a cup of coffee at San Francisco airport during our visit as part of the CII biotech delegation to the BIO convention, Hari Bhartia had shared his vision of how India will emerge as a research laboratory of the world for drug discovery and clinical trials. Bhartia’s Jubilant group has been in the forefront of the transformation of India into the CRO destination. I am sure the Jubilant story and the Bicon group company Syngene’s early visibility and success helped in the formation of Veeda Clinical Research and others in this sector indirectly. With the who’s who of the industry and these eminent award winners present in Bangalore for the Awards Nite on December 22, I look forward to the occasion to make them share their success stories in their own words, in an entirely new format this year. See you all on December 22. sureshn@cybermedia.co.in ]]> <![CDATA[Clinical research in India]]> https://biospectrumindia.com/news/95/1916/clinical-research-in-india.html https://biospectrumindia.com/news/95/1916/clinical-research-in-india.html Fri, 13 Nov 2009 10:47:00 +0530 Clinical research in India The unique position of India in clinical research is no accident, but a result of many compounding factors In India, the clinical research industry has enjoyed a sharp growth like few other industrial sectors. The potential of clinical research in India is not only recognized by the stakeholders and the government; but now, every company must have an ‘India strategy’ regardless of whether it is a pharmaceutical company or contract research organization (CRO). The unique position of India in clinical research is no accident, but a result of many compounding factors. It is an undeniable fact that the spiraling cost of new drug development and declining R&D outputs are driving the pharmaceutical companies to explore emerging markets, giving a boost to clinical research in these regions, including India. However, the industry has evolved from its initial focus on the bio-availability and bio-equivalence (BA/BE) services, and the local pharmaceutical industry to a full service provider to the global pharmaceutical and biotechnology community, including phase I–IV trials and associated services. Transforming factors Several factors have played vital roles in the transformation of the industry. The most prominent factor is perhaps the access to patients across a variety of disease areas, including treatment naive patients,  coupled with medical expertise and infrastructure, and a standard of care that is comparable to developed countries. With a prominent socio-economic transformation and urban-to-rural migration, the disease profile of the country has changed considerably in the past two decades. With increased urbanization, industrialization, and adoption to western lifestyle and diet patterns, there has been a surge in the lifestyle-related disorders. Today, in India, we can see the diseases of both the developing and the developed world. This scenario coupled with a high number of English speaking and well-qualified allopathic physicians provide a unique advantage. The advantage that language offers in India makes the country unique among emerging nations. In addition to all of the above, the cost competitiveness that India offers cannot be ignored. Regulatory environment Another important point is the regulatory environment, which is stable and conducive for the growth of clinical research. The requirements laid down in the revised Schedule Y of the Drugs and Cosmetic Act 1940, which governs conduct of clinical research in India; the GCP guidelines published by Directorate General of Health Services; and ethical guidelines for biomedical research on human participants by Indian Council of Medical Research are in line with the principles laid down by ICH GCP guidelines and Declaration of Helsinki. Over the past few years, regulators have taken definitive steps to enhance acceptability and attractiveness of India as a clinical research destination. The most significant step was allowing the conduct of concurrent phases of drug development with the roll-out of revised Schedule Y in 2005. Some of the recent initiatives such as mandatory registration of clinical trials, and planned ones such as registration of organizations involved in clinical research and enhanced monitoring by inspections, indicate the commitment of the regulators to ensure that regulatory environment is of highest global standards. Areas of attention Even though there has been an increase in the number of competent clinical research professionals, this is not comparable with the increase in trial numbers. While most pharmaceutical companies and CROs have machinery to train their own staff, training of investigational site staff remains an area that requires attention. Each player in the clinical research arena must remember that clinical trials are experiments, while these experiments are an essential step in new drug development, as they deal with human life. This passion must be felt by each member of the clinical research fraternity in India.   ]]> <![CDATA[Drug delivery using silica nanotubes]]> https://biospectrumindia.com/news/95/7355/drug-delivery-using-silica-nanotubes.html https://biospectrumindia.com/news/95/7355/drug-delivery-using-silica-nanotubes.html Fri, 13 Nov 2009 10:38:00 +0530 Drug delivery using silica nanotubes The goal of all sophisticated drug delivery systems is to deploy medications to targeted parts of the body, nanotechnology provides the perfect trigger to achieve this Dr Aninda J Bhattacharyya and his students at the Solid State and Structural Chemistry Unit (SSCU), Indian Institute of Science (IISc), Bangalore, are exploring the possibilities of employing nanostructured materials for diverse biotechnological and environmental applications. They are making use of inorganic and hybrid (i.e. inorganic and organic) based nanostructured materials for controlled drug delivery and biosensing.   Dr Bhattacharyya says, “Recent experiments involving silica nanotubes (SNTs) and other mesoporous oxide materials have been very encouraging and we could see our efforts being useful to the medical fraternity as these porous materials could be used as versatile hosts for drug delivery and biosensing.” The current methods of drug delivery exhibit specific problems that scientists are attempting to address. The therapeutic benefits of several drugs are limited or otherwise reduced because of the partial degradation that occurs before they reach a desired target in the body. The goal of all sophisticated drug delivery systems, therefore, is to deploy medications intact to specifically targeted parts of the body through a medium that can control the therapy’s administration by means of either a physiological or chemical trigger. To achieve this goal, researchers are utilizing the scope of micro-and nanotechnology. Drug delivery nanotechnology is just beginning to make an impact and these IISc researchers are using their expertise in materials chemistry to synthesize and manipulate molecules and supra-molecular structures for producing drug delivery systems with programmed functions. In a recent scientific paper by Dr Bhattacharyya with his student Shobhna Kapoor published an article entitled ‘Ultrasound triggered drug delivery and biosensing using silica nanotubes’ in the journal of American Chemical Society, The Journal of Physical Chemistry-C. The researchers have reported application of SNTs for controlled drug delivery. (Ref: J Phys.Chem.C 2009, 113, 7155-7163) “Inorganic porous materials have attracted considerable attention as hosts for the immobilization of a variety of guest molecules such as proteins, drugs and smaller biological molecules (amino acids, peptides and vitamins). In spite of being in the early stage, the inorganic nanostructured systems, such as, silica nanotubes offer an attractive improvement over prevailing organic systems for drug delivery,” says Dr Bhattacharyya. In the present work, these IISc scientists have reported in detail the procedures used for the preparation of the silica nanotubes. As a case study, the scientists have studied the in-vitro drug release kinetics of the common pain reliever Ibuprofen (IBU) in simulated body fluid (SBF). The extent of IBU loading in the silica nanotubes and several other parameters were monitored using sophisticated analytical tools, such as, thermogravimetry analysis (TGA), X-ray diffraction (XRD), and Fourier transform infrared (FTIR) spectroscopy. IBU release kinetics was observed by monitoring the characteristic peak at 264 nm of IBU by Ultraviolet-Visible (UV-VIS) spectroscopy (Perkin-Elmer, Lambda 35 UV spectrometer). Ultrasound impulses (33 +/-2 kHz) of duration ranging from 0.5 min to continuous and with rest times between successive impulses ranging from 0 to 30 min were given to the SNT-IBU composite during release kinetics. Dr Bhattacharyya observes, “In the present study, considering the drug release yields, say over a period of 24 hours, for Ibuprofen (IBU), our experimental results have been satisfactory. We believe that the drug dosages obtained for the bare silica nanotubes and silica nanotubes containing a coating of organic chemical groups can be further tuned via optimization of the nanotube morphological parameters that eventually leads to improved performance.”  To increase the efficiency of the drug release from nanotubes, the researchers have experimentally shown the beneficial effects of using short ultrasound pulses as external stimuli. The purpose of application of an external stimulus will be highly beneficial for the solvent molecules as well as solvated drug to overcome several nanotube morphological heterogeneities. Further investigations are currently on to study the impact of several parameters on both degree of drug loading and the rate of release. “We have demonstrated clearly the utility of a nanostructured material such as silica nanotubes both as a controlled drug delivery system and as a biosensor. We propose systems such as SNTs employed in the present study, to serve as a prototype for generation of systems having multiple functionalities for potential biotechnological applications, especially for drug delivery,” adds Dr Bhattacharyya. Nanotechnology has a great potential in revolutionizing the drug delivery field and the efforts of scientists such as Dr Bhattacharyya and his team of students at IISc could someday save a great number of lives.    ]]> <![CDATA[Redefine pharma marketing for future]]> https://biospectrumindia.com/news/95/1924/redefine-pharma-marketing-for-future.html https://biospectrumindia.com/news/95/1924/redefine-pharma-marketing-for-future.html Thu, 12 Nov 2009 16:08:00 +0530 Redefine pharma marketing for future If pharma is to create a new marketing and sales model that is fit for 2020, it will have to begin by analyzing its own value chain to identify opportunities for working more closely with healthcare payers and providers The social, demographic and economic context in which the pharmaceutical industry operates is changing dramatically. The shortage of new products, the pressures exercised by payers on pricing and the delivery of innovative products that prevent and cure diseases, combined with an increasing shift to the delivery of personalized healthcare to patients is transforming the way the industry operates and is organized. All these challenges have major ramifications for the way in which pharma markets sells the medicines it develops. The industry has traditionally relied on aggressive marketing to promote its products. Many of the industry's biggest markets are now saturated with sales representatives, and its selling techniques are becoming increasingly ineffective. Hence, the fact that returns on detailing via sales visits to doctors have begun to decline in the developed world. Direct-to-consumer (DTC) advertising-the other big weapon in pharma's marketing artiller-has also failed to deliver on industry's expectation. In short, aggressive marketing- whether to doctors or patients-is becoming increasingly ineffective as a means of stimulating demand for new therapies and overcoming reluctance to pay premium prices for products that are deemed to offer only minor clinical improvements. Industry critics are also becoming increasingly vociferous in their complaints that it is wasteful or even unethical. Big pharma has responded with various cost-cutting measures. Pfizer set the pace in late 2006, when it said that it would cut 20 percent of its US sales force. Other companies rapidly followed suit and, by October 2008, the industry leaders had announced plans to shed another 53,300 jobs, many of them in marketing and sales. However, both industry executives and commentators recognize that the failings of the current marketing and sales model cannot be addressed simply by reducing the size of the sales force; the problems go very much deeper. It is believed to stem from three incorrect assumptions, namely: Pharma alone determines the value of its products Products alone create value The buying and selling of medicines is based solely on technical data like safety and efficacy, as distinct from subjective criteria like quality of life. If pharma is to create a new marketing and sales model that is fit for 2020, it will have to begin by analysing its own value chain to identify opportunities for working more closely with healthcare payers and providers. It will, for example, have to collaborate much more closely with payers (governments, health insurers, employers or patients) to ensure that it develops medicines which have real social and economic value. Moreover, the burden of proof will be much greater for specialist therapies costing many thousands of dollars than it is for primary-care treatments-and, as multiple products for treating specific disease emerge, the pressure will only increase. For example, Herceptin has long dominated the market for breast cancer, but with the launch of Tykerb, GSK has produced a serious rival to the throne. Pharma will have to supplement these new medicines with a wide range of health management services in order to improve compliance and protect the value of its products, as performance-based pricing becomes a pre-requisite for reimbursement in its core markets. This will entail the formation of numerous alliances with local service providers and sometimes, even rival manufacturers-alliances that are much more sophisticated than the arm's length arrangements in which most companies currently engage. It will also entail the development of a secure, interoperable technological infrastructure, the management of new intellectual rights issues, the creation of much stronger brands and the redefinition of the industry's role. The shift to performance-based pricing will dictate other changes too, including the need for a more flexible approach to pricing. The introduction of live licensing and increasing importance of the emerging markets will reinforce this trend. And if it wants to tap into the potential of the emerging world, it will have to use differential pricing-both within and between countries. Many of the industry leaders will also have to develop comprehensive strategies for marketing and selling specialist healthcare packages, a process that will require major organizational and cultural changes, including the development of new skills and routes to market. One of the biggest decisions these companies face will be what sort of business model to use. Various new models are emerging, both inside and outside the industry, and there is much that pharma can learn from looking over the fence. Lastly, most if not all, pharmaceutical companies will have to transform their marketing and sales functions. By 2020, the role of the traditional sales representative will be largely obsolete. Conversely, the industry will have much greater need of people with the expertise to build brands; manage a network of external alliances; negotiate with governments and health insurers; liaise with secondary-care specialists; and communicate with patients. These are enormous challenges. Yet if pharma can overcome them, then it will be able to slash its expenditure on marketing and sales. Consulting healthcare payers during the development process will put it in a much better position to ensure that the billions of dollars it invests in R&D are wisely spent, and eliminate the need to spend massive sums persuading increasingly skeptical doctors to prescribe medicines whose clinical superiority may be questionable. Focusing on specialist medicines will provide new commercial opportunities and reduce the risk of generic erosion. And creating healthcare packages for treating specific conditions will safeguard the value of good medicines, as well as providing new revenue streams and garnering greater loyalty from patients. ]]> <![CDATA[Swift diagnosis for technical selling]]> https://biospectrumindia.com/news/95/2409/swift-diagnosis-for-technical-selling.html https://biospectrumindia.com/news/95/2409/swift-diagnosis-for-technical-selling.html Thu, 12 Nov 2009 16:02:00 +0530 Swift diagnosis for technical selling When it comes to basics like customer service and technical support, several firms find themselves totally out of sync with customer expectations, and the realities in the laboratories or on the shop floor The pump that was guaranteed as 'leak-proof' started leaking within five minutes of installation. To make matters worse, the needle on the pressure dial remained immobile at all pressures! The noise level of the pump was much higher than what the sales person had promised at the sales presentations. The reputation of the attending company service engineer and the technical expert was in tatters, even before they had a fair chance to impress the new customer. Murphy's Law? 'If something can go wrong, it will go wrong'. While existing customers are far more understanding and tolerant of product and service failures because of the trust that has developed and the relationships formed over previous transactions, a nightmare like the one described above can seriously fracture the confidence of the new customer. It is surprising that when it comes to basics like customer service and technical support, so many companies find themselves totally out of sync with customer expectations and the realities in the laboratories or on the shop floor. Can 'egg on the face' situations be avoided for both new and existing customers? Could the factory acceptance and site acceptance tests on the pump have been planned better? Could the pump have been subjected to more rigorous tests before dispatching to the new customer? Did quality control do its job? And several such questions would arise. Inadequacies and misadventures in customer service and support should be looked upon as major opportunities. Or to state it more politely, it can create the difference between one brand and the preferred brand. The difference lies in the service approach the company subscribes to. Is top class support a cost? Or is it an opportunity to cement existing customer relationships, realize a continuing stream of revenues from a satisfied and brand loyal client, acquire more new business through outstanding customer referrals and testimonials? Can a track record of excellence in support and service be built brick-by-brick with the new customer and leveraged from the first step of the business relationship and add to company revenues and profits from service and support ? Companies that subscribe to the latter, more correct view back up their beliefs with real investments in the CRM process. How many companies engaged in the business of selling complex, technical tools and technologies to B2B customers have really understood, and meaningfully aligned the different elements of the CRM model? What could be some meaningful service metrics? First Call Resolution (FCR) â€“ whether over the voice based system, the help desk, or the actual service/support engineer's visit. Are people and processes of the company tuned to this concept? Are they even aware of it? Sure, not all problems, especially technical problems can be addressed in the first call. But the point is, are FCRs being measured and analyzed? Suppose, out of 100 service requests only 20 percent are FCRs, and the remaining 80 percent are customer requests that require multiple service/support. What's the mean time between failure (MTBF)? Is it within the norms accepted by the customer or is it that despite MTBF being very low (suggesting poor maintenance and improper use) you are happy that it is 'within SOP Norms' fixed arbitrarily by company policy? What is the mean time taken for diagnosing the problem? Is it spiraling upwards? What is the mean time taken for repairs? Does it imply poor trouble-shooting skills or unavailability of service parts? Are your support and service people overloaded and too stretched? Yes, you have a sophisticated software-based service/support system in place, one that your company paid through its nose, costing a cool Rs 21 lakh! It accepts customers' service related calls toll-free, it logs in all the complaints nationally and even generates reports for you. The point is how have you used the data and information available to craft or re-craft service strategies and policies for continuous improvements. If the customer satisfaction index (CSI) still hovers at a dismal 70â€“75 percent year after year, have you achieved anything at all? Perhaps FCRs and root cause analysis will demonstrate the real problems and their causes; efficient time frames required to resolve them or the crucial area of training to reduce them. Training is a critical pre-requisite for delivering top-end service and support. Unfortunately, design and implementation are given more importance in organizations. While the HR department is the most remote from the field. Most HR staff, with the foresight of ostriches, believe that product and technical training is more than adequate and is in fact 'the perfect antidote' to 'ramp up service levels'. A very critical component of effective and good service/support is the handling of customer relationships and customer perceptions. It demands a great variety of soft skills. Skills like persuasive communication, tact, and patience have to be taught to service/support people. How to diffuse and handle a crisis? What are the best techniques to handle objections or anger? How to buy more time from the customer? How to communicate and share the nature of the problem with the customer? Can one tell a harmless 'white lie' or should one openly share all the 'moles, warts and pimples' of the issue with total integrity with the customer ? Service engineers straight out of college are at a total loss to handle such demands professionally. Few HR trainings focus on this. The result is that instead of giving good service they end up being good servile servants! And when it comes to impacting company image, there is a big difference between being servile and being service oriented. Nor can companies afford to wait for these engineers to acquire these skills after sixâ€“eight years of on-the-job learning. So, coming back to the beginning â€“ how could the service engineer have handled the pump failure problem with his new customer? First, by aligning himself with the customer, acknowledging the problem to the customer openly. Apologizing and then demonstrating to the customer some immediate, real and concrete action. No excuses, no quoting of constraining company rules or procedures. Swift diagnosis (not a trial and error approach), calling up the service center for a stand-by pump given the criticality of the pump for plant operations, an explanation to the customer on why the leakage cannot be plugged at the customer site. And reassuring the customer by calling up the service head in his presence. After all the customer, like our boss, believes that his service guy should not be 'paid to be a part of the problem'. ]]> <![CDATA[Managing clinical research business in modern times]]> https://biospectrumindia.com/news/95/1829/managing-clinical-research-business-in-modern-times.html https://biospectrumindia.com/news/95/1829/managing-clinical-research-business-in-modern-times.html Thu, 12 Nov 2009 15:47:00 +0530 Managing clinical research business in modern times Each area in a CRO operation requires different type of investment and skills—it has a long term bearing on future earnings and business growth Clinical research business, like any other business has its own nuances. There are a variety of activities and skills required for each activity. It is always a challenge to build a sustainable long-term business model, and a proper infrastructure planning at a formative stage will help to achieve this. If we look at the  successful clinical research organizations (CRO) in the US and Europe, they offer a wide range of services starting from early phase development, proof of concept, phase I–IV clinical trials, clinical data management and software services in life sciences. Majority of the CROs in India are feeling the heat of overcapacity, large manpower and very few lines of business operations. They have invested heavily in just one of the areas of clinical research such as BA/BE studies or phase III clinical trials or data management. They are caught in the web of sustaining current business/concentrating on capacity utilization and managing shrinking profitability by cost-cutting/downsizing, rather than growth and expansions. Some of the questions constantly asked by the CEOs of CROs are:- (a) how do you address a situation where profitability starts shrinking from a high of 40 percent? (b) how do you retain talent in this highly competitive market where employees are offered 100 percent hikes in salaries year-on-year to a more realistic 10 to 15 percent increase? (c) how do you keep abreast of growing regulatory requirements? (d) how do you stay ahead of competition? Strategies There are some important considerations, which owners/CEOs should address at a very early stage. Each area in a CRO operation requires different type of investment and skills, and has a long term bearing on future earnings/ growth of business. Risk mitigation In every business, the first strategy is to identify business risks and work out a risk mitigation plan. First risk is to reduce dependence on a single or few clients. Most CROs are dependent on a single or few clients rendering themselves vulnerable to the fortunes of those clients. The second most important risk is disproportionate  expansion in a particular area of operation. This seems very attractive in the short term. But CROs will be caught in the vicious cycle of overcapacity, price war, and unwieldy manpower. It is important to draw a limit for each line of activity and concentrate on diversification into other areas of clinical research. The best models can be obtained from the CROs in the West. Productivity Keep an eye on the productivity of each employee on the basis of volume of activity and not on the rupee value of projects. Initially, all CROs will see a growth in the value per project as they graduate from local clients to foreign clients, pilot studies to pivotal studies, and zero regulatory track record to several FDA approvals. The value graph will flatten out due to competition as more and more CROs start catching up.     Training Invest on people constantly. Companies invest on people in two ways. One way is to compartmentalize employees into certain departments, and train them  well in only one area of operation. Large corporations adopt this strategy when they have a sustainable order pipeline, clear employee lay off contracts in case of business loss. On one hand, this is detrimental to the interests of the employee, and inflationary for the company on the other. Medium sized CROs should adopt a multi-tasking training strategy. The training programs should be designed in such a way that 25 percent of the training component in a year should support future business expansions or diversification plans. The employee should be allowed to learn different sets of skills, which the company can make use of in future. This strategy may lead to a percentage of people leaving the organization for better prospects due to skills they acquire from this training. However, a CRO can always strike a balance of such variability based on its business plans and growth. Networking CRO industry is highly skewed towards technical skills and regulatory compliance. It requires huge amount of time, effort and money to set-up, expand and maintain the same. One way of being ahead of competition is to network and compliment efforts than set up everything under one roof. It is an accepted fact that a CRO is not expected to be an expert in every therapeutic area under the sun, and is abreast of every regulatory requirement laid down. Macro Economic Factors It is important to periodically review the benefits emerging markets offer as a country in terms of pricing and patient load  in comparison to other low cost countries. A strategy to go global should be in place to mitigate risks related to economic factors. Social Factors CRO business cannot ignore the benefits it derives from the lower strata of the society. Most of the patients who participate in clinical  trials are from low economic background, and  who cannot afford quality medicine. CROs should actively pursue development of better infrastructure by reaching out to hospitals which have never heard about clinical trials. This will help modern techniques of treatment available to a larger population. A CRO can succeed only when its vision is a blend of three factors – commercial gain, employee welfare and social benefits. No CRO can succeed without skilled people and active participation of the  society. CRO industry carries a huge responsibility to the society. The focus should be on delivering quality service by developing people and building good infrastructure.     ]]> <![CDATA[Clinical trial supply market thrives in India]]> https://biospectrumindia.com/news/95/1985/clinical-trial-supply-market-thrives-in-india.html https://biospectrumindia.com/news/95/1985/clinical-trial-supply-market-thrives-in-india.html Thu, 12 Nov 2009 14:52:00 +0530 Clinical trial supply market thrives in India With more and more clinical trials being outsourced to India, it is only logical for sponsors and CROs to start sourcing the clinical trial supplies from within India India began to utilize the opportunities in clinical trials few years ago. Some companies grabbed the  opportunity, some looked at it and some simply created obstacles. Now the sector offers lot of hopes. Today, after conducting more than 700 clinical trials in India, the market seems to have matured and more and more companies and service providers are getting attracted to this promising market. Other than  clinical research organizations (CROs), we now have support companies like clinical trial supply (CTS) companies, life science logistics companies, clinical trial material depot providers, specialized packaging companies, software solution providers, and clinical trial data management companies and a host of other companies that have emerged in the last few years are capitalizing on the clinical trial market growth in the country. These ancillary industries of particular interest and relatively naive territory provide huge ‘clinical trial supply market’ opportunity. With more and more clinical trials being outsourced to India, it is only logical for sponsors and CROs to start sourcing the clinical trial supplies from within India. Prohibitive cost of imported clinical material, lead time for procuring import license and ambiguous regulations for imports have created a need for a reliable and efficient local clinical trial supplies partner with global reach more imperative than ever before. As per an estimation study by the global consulting firm, Mckinsey & Co, European and the US pharmaceutical companies will spend $1.5 billion (about Rs 7,038 crore) per year on clinical trials in India by the year 2010. Though there are no scientific estimates available for determining the share of clinical trial supplies as a percentage of this total cost, even we conservatively estimate only 10 percent as the cost of clinical trial supplies, we are looking at a market of around $150 million (about Rs 703 crore). And this market would definitely grow at a rate faster than the rate at which CRO industry is growing locally (30-35 percent), as it would not only cater the domestic trials but also cater to the export market of the clinical trial supplies. In India, the CTS industry is still at a very nascent stage with only a very few companies like Rubicon Research, Bilcare and Thermo Fisher have forayed into this segment offering varying services and expertise. Rubicon offers a one-stop-shop for all clinical trial supplies, right from manufacturing and packaging including labeling, blinding and randomization to CTM depot services, while companies like Bilcare offer only clinical packaging services. For Rubicon Research, CTS has been a natural vertical integration of its formulation development services, and for Bilcare, it is a diversification from its core packaging business. The opportunity for CTS companies lies in offering clinical trials supplies services to clients including clinical manufacturing, packaging, labeling, blinding and randomization and depot services. Services offered by CTS companies should be differentiated value-added services that can provide the flexible infrastructure needed to accommodate the complex and variable requirements for CTS. These differentiators in terms of capabilities have been illustrated below: Opportunity and potholes In spite of the high expectations on India to do well in the area of pharmaceutical R&D, there are many concerns that hinder the growth. The hindering factors include the lack of adequate skills, unrealized market  potential and inadequate infrastructure in many areas of CTS, imprecise documentation systems arising out of ambiguities in the interpretation and implementation of global clinical trial protocols and requirements for world-wide multi-centered CTM depot. While India still could offer CTS at economical costs, there are concerns about the quality aspects. India has for long been viewed as the low cost destination for clinical trials. The country  has also gained a dubious reputation of low quality, thus marring image in the process. This would mean that Indian supplies would be viewed with suspicion, and though, we would be rightly expected to deliver high quality global supplies, clients from the regulated markets or otherwise would still be looking at substantial cost advantage. This cost advantage would be difficult to provide considering the heavy investments that are needed for putting up a US FDA approvable manufacturing and packaging plant for CTS supplies,  and the long gestation periods for return on investment, considering the sporadic and non-cyclical nature of manufacturing and supplies, unlike a typical supply chain set up. Therefore, India needs to strike the right balance between quality and economics in cost. Joint  efforts are needed from the industry and regulatory bodies to ensure that India’s relatively late entry into the CTS arena is without any regulatory bottlenecks, quality and cost prejudices.    ]]> <![CDATA[Marketing strategies for pharma companies]]> https://biospectrumindia.com/news/95/1663/marketing-strategies-for-pharma-companies.html https://biospectrumindia.com/news/95/1663/marketing-strategies-for-pharma-companies.html Thu, 12 Nov 2009 14:17:00 +0530 Marketing strategies for pharma companies As pharma industry steps into the  ‘global local era’ of marketing, it will witness its own share of changes that would indicate the paradigm shift for pharma marketers Traditional pharma marketing has focused on ‘prescribing doctors’ with huge sales forces that were often directed to follow the carpet bombing method. Promotional budgets were high as those times were unknown of the phenomenon called recession. Mass communication was the norm and money was poured in to reach out to a huge number of largely scattered mass. Marketing plans are centered on product features and benefits in addition to sales force strength.   Days of traditional pharma marketing are nearly over. In order to make present era successful and profitable, marketing strategies have to be realigned. Marketing and commercialization strategies are developed on the strong foundation of targeting and segmentation of customers and markets, to accommodate the evolving marketing dynamics and customer feedback.  From initial concept development to post launch assessment, customer  inputs  on design and positioning of a product are essential. Attempting to bring a product to market without sufficient customer feedback will ultimately limit product acceptance in the market place.  Customer feedback should be holistic and include the parameters like validating the market assumptions, assessment of the competitive environment, input on product specifications, determining the product value proposition, developing and testing the product positioning and obtaining product feedback on product’s effectiveness  and compliance. It is important to develop a decision making process which can be followed through to the customer feedback for further development of product to analyze manufacturing costs, redesigning the communication strategy, value-added services, product availability through efficient logistic network and sometimes even the timeline for product launch.  The companies themselves need to bring in brand developers and health marketing experts to their organizations, and allow them to make a change. At the same time, support measures are required to start focusing much more on means to elevate the marketing and commercialization capabilities and implementation of those activities.  In contrast to traditional norm of mass communication, today, the product is promoted through personalized communication strategy and media like web-based initiatives, interactive teleconferencing and text messaging. The broad idea remains to tap as many technologically enhanced communication ways as possible. Further, companies are training their field forces for a two–way  communication with the customers. We can say that consultative marketing is gaining importance. With advances in science and technology,  we have to keep in mind the pace needed to keep up in the industry which is entering a critical period in its development. A failed product launch can be disastrous from a financial perspective and to the reputation of the product’s brand in the marketplace.  Meticulously prepared comprehensive marketing strategy is essential for the successful commercialization of a brand. Highly pro-active marketing leadership would be instrumental in taking timely initiatives in response to the customer feedback and evolving market dynamics resulting in greater potential for overall market success. ]]> <![CDATA[Funding, partnering lessons for biotechs]]> https://biospectrumindia.com/news/95/1270/funding-partnering-lessons-for-biotechs.html https://biospectrumindia.com/news/95/1270/funding-partnering-lessons-for-biotechs.html Tue, 10 Nov 2009 15:21:00 +0530 Funding, partnering lessons for biotechs Biotech leaders who want to stay in step with the trends need to rethink how to monitor and then effectively communicate with their investors and big pharma alliance management community Recently, as I was interacting with CEOs and PE leaders, after conducting a round table on personalized healthcare opportunity in India, a leading CEO from a mid-sized biopharma company remarked that opportunities for the mid-sized companies in India for partnering and funding innovation are over. As one looks at the number of PE deals in India in the sector, they have steadily increased from virtually nothing in 2003 to around 30 in 2007 and reducing by half in 2008. On the other hand, different models for partnering and risk sharing emerged during the same time as large global pharma companies executed partnering models in Asia, including India, with 2007 being the peak of the partnering deals signed in India. In 2008, PEs were taken for a surprise, when access to capital and liquidity events was brought to a halt. Biotech valuations were drastically reduced and firms were forced to inject additional capital into businesses that were seemingly predictable as the alliance managers of large pharma scaled down their ambitions. In 2009,  there is a rebound in deals with a total of approximately $130 billion (about Rs 612,947 crore) have flowed from 321 deals in the first half of this year in the US alone. However, number of deals has lagged in India in 2009 as compared to the trend seen in the West. So, does this signal the beginning of an end of a dream,  and the drying up of funding and partnering deals pipeline in India? Key trends A large number of companies were emerging in India in biotechnology, without the full resources to take the product through to full-scale development and global commercialization. Investors and global pharmas demand for evidence for continued growth and endorsement of technologies. Labor cost arbitrage for scientific and clinical talent to reduce the cost of drug development-to-launch. Biosimilars segment offering huge potential for out-partnering with large biotech and pharmas to call back molecules. Clinical biomarkers or diagnostics linked to gene expression profile of individual or sub-populations of patients is an essential feature of stratified or targeted medicine. This type of research attracts and often is best pursued by small biotech companies in India. Collaborative development financing (CDF), where an investor provides capital and clinical expertise in exchange for licensing of a biotech’s pipeline. Non-profit foundations have adopted a more investor-like approach¯early-stage funding for proof of concept and target validation, as well as project management support, and access to their network of scientific experts and research clinics critical in translating discoveries into the clinic. The overall trends do validate that the key drivers for funding and partnering in India have not structurally changed to witness the opportunities in biotech diminish as generally perceived in the short-term. But the most important ingredient for a healthy funding and partnering deals pipeline for Indian companies that offer a long-term growth at a compelling risk-reward ratio. The Indian companies in the small and mid-size sector should better prepare themselves for the upturn. Here are a few pointers. Prep-up to these changes Biotech leaders who want to stay in step with these trends need to rethink how to monitor and then effectively communicate with their investors and big pharma alliance management community. Most small-and mid-sized biotechs are looking at raising capital for immediate and short-term needs (round B or C), signing up strategic partnerships building capability base in India and their business development capability overseas, and preparing for target valuation for IPO or acquisition. Given the current scenario, it would be prudent to keep a buffer of 20–25 percent for the delays and uncertainty, and a lead time of anywhere between 9–12 months. Most importantly, it is imperative to research out and target your investors and learn about their preferences and the competencies they bring to the biotech. It would be wise to avoid those investors or firms with competing investments in other Indian or foreign biotech companies. Partnering deal types Most Indian biotechs are entering into deals that range from low-risk models such as fee for service, milestone-driven fees payment. Many of them have turned away highly risky models such as co-development, co-commercialization and joint ventures. Newer partnering models are emerging that balance the risks and outcomes for the partners. Most partnering arrangements have a deep impact on the biotech venture financing and its terms and sustainable future. It is time that these risk-reward issues are balanced out with the future stability of the company. Valuation of IP or company As new investors and larger pharma are getting more sophisticated understanding of the science and the principles of valuation based on factors such as IP, cost of clinical development, time to commercialization, size of the therapeutic segment, quality of clinical data, competitive factors, impact on other R&D programs, and royalty cash flows, newer valuation models have emerged to reflect reality other than traditional valuation approaches such as net present value (NPV), discounted cash flows (DCF), and internal rate of return (IRR). Advisory board and subject matter experts Nowadays, as alliance partners and investors are turning the due-diligence process on its head by using tools to research biotech companies in India, those same companies in India should consider similar moves. A panel of experts can provide invaluable information to an investor and similarly an expert panel can help the CEOs of the small and mid-sized biotech companies understand where they meet, and where they fall short on alliance and investor expectations. Once these companies understand how their partners and PE  investors perceive them, they can then start working to fill in gaps, recast messages, better explain strategy, and so forth. The process could even result in changing scientific and business practices, as expert panels can bring a fresh perspective to companies that aren’t realizing their full potential. To be or not to be As the line between biotech and big pharma blurs aside from mergers and acquisitions and partnering, pharma companies are starting their own initiatives. Pfizer pledged to spend $50 million (about Rs 235.75 crore) for a San Diego incubator; Lilly spent $560 million (about Rs 2,640 crore) to expand its biotech operation; and Roche in late 2007 announced that it would plow $255 million (about Rs 1,202 crore) into expanding its biotech research and development. Some of these plans have been scaled back last year in the wake of the economic downturn. The stake sale of Ranbaxy does signal questions in the minds of CEOs in the small and mid-sized Indian biotechs, as a stand alone, do they stand a chance with sustainable revenue models of growth for their innovation? The jury is still out there. ]]> <![CDATA[Role of biologicals in pandemic]]> https://biospectrumindia.com/news/95/2752/role-of-biologicals-in-pandemic.html https://biospectrumindia.com/news/95/2752/role-of-biologicals-in-pandemic.html Tue, 10 Nov 2009 15:21:00 +0530 Role of biologicals in pandemic The world is facing an unprecedented threat from swine flu, caused by the now well-known H1N1 virus. Biological preparations can play a very effective role in combating the situation Initially, we saw some actions and some knee-jerk reactions to swine flu threat. Initially, masks covering people’s faces in cities and villages were a common sight. Later it seems to have given way to complacency. Media reports on swine flu have also taken a break. May be, the proverbial honeymoon period is over. Everyone is talking about one particular anti-viral drug. We have no idea of the generic name of the drug, but we hear about the brand names. Vaccines are being developed and tried, so we hear about them.  Fears of the virus outsmarting the scientists by mutating are also aired. The article is not being written forgetting the fact that vaccines are also biologicals. In this context, it is worth spending a little time on the mechanism of infections, and the way human body is dealing with it. Any infection ultimately is cured by the body itself. Drugs basically prevent the proliferation of the bacteria or virus and the body takes over the rest. There is an eternal fight going on between innumerable disease-causing organisms and our body’s  ‘army’. And in order to keep us healthy or disease-free, these fighter cells with the help of certain proteins and particular substances present in our blood and body fluids are engaged to combat disease-causing organisms everyday. If the battle is lost, we fall ill, and if our ‘army’ keeps winning, we remain healthy. Biological preparations can play a very effective role in combating the situation. Vaccines are the best bet.  It is the best preventive measure. It takes a little time to show the effect. There is a gap between the introduction of the vaccine and its desired effect of protection. This gap can be bridged by passive immunization. To understand this situation, we need to go back to the basics of immunology. This is intended only as a reminder to the readers. Any infection, exposure or vaccination leaves the memory in our body with a complex mechanism so that the system is pre-warned to circumvent any such eventuality in future, and this is termed as immunity. The word ‘immune’ literally means ‘exempt’. That is to say, the process exempts us from the vulnerability to the particular infective agent. The primary immune response takes about a week to produce sufficient amount of antibodies to neutralize, kill or eliminate the invading infectious agents. This time, gap is taken care of by the use of drugs and medical intervention. Antiviral or antibacterial drugs either kill or prevent their replication.     This gap can be bridged by passive immunotherapy. Let us get familiar with few of the complicated jargon scientists use. Starting with the word ‘antigen’, generally, a foreign substance when introduced knowingly or otherwise, is capable of starting an immune response resulting in the production of  ‘antibodies’.  Antigens could be a whole or parts of bacteria, viruses and fungi.  While antibodies are proteins capable of reacting against the particular antigens, which are produced by the immune system of our body. They are very specific, and that is the reason why we have to get all those injections for various diseases. That is also the reason why we are waiting for a new vaccine for swine flu which has to be very specific. It is common knowledge among medical and biology students that the immune response takes about a week, and in the meantime, passive immunization can be the life saving measure. As a precaution, human blood of healthy individuals containing these antibodies in a pure and concentrated form can be used to ‘bridge’ the gap. By that time, the body takes care of itself with the support of drugs and medical care given. This method could substantially reduce the complications. To be more specific, along with life support systems and antiviral drugs, use of immune serum globulins or ready-made antibodies can be effective. This is a well-known and proven method of treatment for viral and bacterial infections. Immunotherapy in conjunction with antibiotics or antiviral preparations could be a good alternative. There are several such preparations for intra-muscular and intra-venous administration. Probably, physicians and policymakers can give this a thought. However, this line of treatment is not mentioned by any media reports so far. Cost and the efficacy of the available treatments may need closer examination and evaluation. At the same time, there is nothing wrong in exploring this line of treatment that is based on biologicals.  Scientific community should work on exploring the possibility of alternative cheaper antiviral drugs, other systems of medicine and newer lines of treatment. Swine flu is predicted to play long innings.  ]]> <![CDATA[Collaboration The key for vibrant vaccine market in Asia]]> https://biospectrumindia.com/news/95/2710/collaboration-the-key-for-vibrant-vaccine-market-in-asia.html https://biospectrumindia.com/news/95/2710/collaboration-the-key-for-vibrant-vaccine-market-in-asia.html Tue, 10 Nov 2009 15:00:00 +0530 Collaboration The key for vibrant vaccine market in Asia Successful partnerships with vaccine manufacturers include three critical components. They are industry experience, technical expertise and comprehensive training As a major high-end supplier to the Asian vaccine market, Millipore has played a major role in contributing to the growth of the market over the past few years. Although the issues vary from country to country, we see a number of common trends affecting vaccine manufacturers throughout the region—and clear implications for suppliers who want to compete successfully in this expanding and exciting industry. Industry Trends: Higher volume, higher quality The vaccine market in India is growing at 20 percent per year; and in China, the growth is at 15 percent per year. Figures like these point to sustained double-digit growth throughout the region, and signal Asia’s rapid emergence as an important player in the $21 billion global vaccine market. The major trend underlying this growth is the increased government support in the form of investments to boost the vaccine industry—particularly in China, India and Indonesia. This increased spending is fueling industry expansion and with it, a new focus on meeting international quality standards.   For example, to increase their market share, a growing number of vaccine  manufacturers in Asia are applying for the World Health Organization (WHO) pre-qualification, signaling their willingness to adopt more uniform quality standards in all phases of vaccine production. We see a similar trend towards higher quality manufacturing in the pharmaceutical market, where a growing number of firms are focused on meeting cGMP (current good manufacturing practice) regulations—strict standards governing exports that are enforced by regulatory agencies such as the Food and Drug Administration (FDA).  Although local enforcement varies from country to country, many drug manufacturers in Asia have begun following the same standards for both their domestic and export markets. In China, in the wake of international concern about the safety of food and drug exports, stricter cGMP standards for APIs (active pharmaceutical ingredients) will come into  effect in January 2010. The new standards will expand requirements related to production processes, quality control, validation documentation and personnel qualifications.  An increased focus on global pandemic readiness in the face of the H1N1 threat is also accelerating the move to stricter compliance with quality standards. Manufacturers are competing to produce an effective vaccine in the quantities needed to meet the demands. All  these trends—combined with rising local health standards and the expansion of multinational pharmaceutical firms into Asia—have led to increased competition and a move to more efficient, higher volume commercial vaccine production throughout the region. Many older vaccine companies and academic labs, which for the past 30 or 40 years have focused primarily on low-cost; and low-volume products to meet local needs must now compete with larger firms, which are looking to expand their customer base beyond their borders. More important, from a high-end supplier’s perspective, these trends have led to the demand for greater quality in vaccine manufacturing. To compete in highly regulated markets and improve the safety and purity of their products, many vaccine producers must make a rapid transition to newer, and better production methods. This transition is complex. The new regulatory environment has led some manufacturers to opt for single-use disposable technologies, in order to avoid the regulatory obstacles associated with the re-use of devices and the high costs of capital equipment investments. It has also led to increased industry consolidation, as firms look at new ways to afford the higher costs of compliance.  Key to successful partnership Considering the growing competition and costs, heightened quality expectations and stricter safety enforcement, vaccine manufacturers are looking to their suppliers not only for higher quality products, but for greater support and closer collaboration at every stage of production. From Millipore’s perspective, successful partnerships with vaccine manufacturers include three critical components. They are industry experience, technical expertise and comprehensive training. There is no substitute for broad industry experience. Suppliers who can bring to customers a global perspective, an understanding of best practices and a breadth of knowledge based on a long-term investment in the industry, are best equipped to help manufacturers gear up for the future. Technical expertise is probably the most critical requirement for successful partnership—and also the most difficult for suppliers to achieve and maintain.  Vaccine manufacturing is a complicated, demanding and expensive process. The production of polysaccharide-conjugate vaccines for common childhood infectious diseases such as pneumonia and meningitis, which are of high priority for the WHO and is particularly complex and costly.  Suppliers must provide top-quality products for this complex manufacturing environment, because second-rate products no longer meet the strict standards for sterile  manufacturing. But beyond that, they must provide experts who understand technologies, products and applications unique to the production of specific vaccines, as well as the complex regulatory requirements involved at every stage of production.   These experts must work side by side with scientists and technicians to develop, optimize and trouble-shoot their production processes. There are no shortcuts to producing safe and effective vaccines. The third component of successful partnership—and probably the most neglected by industry suppliers—is continuous and comprehensive training. Suppliers must provide both formal classroom training and hands-on coaching not only in the operation of their products, but also in the principles of operation, so that users can understand the products and the ways to trouble-shoot problems. To meet the demands of the new regulatory environment, suppliers must also offer documented training, partnering with local educational institutions and government agencies. Eye on the future For suppliers who make a sustained and long-term commitment to the Asian vaccine industry, the future is bright.  Productive partnerships between manufacturers and their suppliers will fuel further industry growth as their technological expertise increases through close collaboration with experts, manufacturers will be able to produce new products to meet future demands. When it has achieved the WHO’s current goal of addressing common infectious diseases, the industry will be in a position to tap its collective knowledge to produce advanced therapies for even more complex diseases. For Millipore, it is exciting to be part of this growth and to play a vital role in this important market. Partnering with Asian vaccine manufacturers is one of the ways we fulfill our corporate mission: to collaborate with customers to confront the world’s challenging human health issues.   ]]> <![CDATA[Single Cell Biology: A key research area]]> https://biospectrumindia.com/news/95/1003/single-cell-biology-a-key-research-area.html https://biospectrumindia.com/news/95/1003/single-cell-biology-a-key-research-area.html Tue, 10 Nov 2009 14:10:00 +0530 Single Cell Biology: A key research area Development and commercialization of economical, easier-to-use single cell tools have enabled more researchers to explore this novel area The ultimate biological unit lies within a single cell. Many biological disciplines aim to elucidate the causes of cellular differentiation at this level. The secret triggers that signal human maturation, regeneration and genetic diseases lie buried in a single cell that was originally part of the genetically cloned, multicellular organism. Despite careful work with sophisticated instrumentation available for the dissection of tissue samples, several studies suggest that pooled cell samples, thought to be homogeneous, often composed of cells with quite different phenotypes.1 Development and commercialization of economical, easier-to-use single cell tools have enabled more researchers to explore this novel area. These include means to isolate single cells, such as fluorescence activated cell sorting, laser capture microdissection, optical tweezers and atomic force microscopy. Once single cell samples were readily available, applications such as fluorescent in situ hybridization (FISH)2 and single cell PCR3 could be used to identify the differences between populations of single cells. This has resulted in an explosion of work and speculation in the field of single-cell biology.4-6 Adapting multicell/tissue techniques to single cell study often has limited utility because of technical shortcomings, with problems mostly related to sensitivity. Despite the raw potential for single cell genomic analysis, the field has been restricted to comparative analysis of relatively few genomic loci for large numbers of single-cell isolates. Techniques such as FISH or single-cell PCR can only be used to probe a small number of DNA sequences before the cell is destroyed. Likewise, the small sample size of a single cell has so far allowed limited investigation of gene expression, proteomic make up and the characterization of cell metabolites. Whole genome amplification (WGA), a non-specific amplification technique, offers means to overcome the above restrictions for single cell genomic analyses. There are three different strategies for WGA which have been observed so far. History Linker adapter PCR was first described in 1989.9 In this method, the target DNA is digested with an appropriate restriction enzyme and then each end is ligated to an adapter. These known adapter sequences are used to uniformly amplify each of the many DNA fragments representing the original sample. The method relies on absolutely efficient ligation and unbiased amplification between the identical primed regions. Primer extension preamplification (P E P) PCR, in contrast, uses a set of random hexamers to prime template DNA.10 The subsequent thermal cycling conditions use very low (permissive) annealing temperatures and fifty or more cycles to create a series of fragments representing the original input DNA. Bias in the resulting P E P PCR product is due to nonuniformity of random hexamer annealing and extension-DNA section with infrequent or distant priming events tend to be discriminated in this method. These shortfalls were largely overcome with multiple strand displacement (MSD) amplification.11 The MSD technique employs a unique and highly processive mesophillic DNA polymerase, phi29. The resulting product consists of long, 1,050 kb fragments, but good amplification and representation. Finally, degenerative oligonucleotide primer (DOP) PCR, also described as arbitrary PCR, relies on a set of oligos with a random 3'-end and partially fixed 5'-sequence.12 These primers are designed to anneal DNA sample. Once extended by a polymerase, these products are amplified using oligos by targeting their fixed sequences. Primer design is critical for this technique â€“ the oligo must bind evenly throughout the DNA sequence but not bind to other oligonucleotides. This method has also been successfully applied to give representative samples. Single cell analysis Each of these techniques has been applied to the problem of amplifying the genetic material in a single cell, and has met with some success. P E P PCR was the first to be applied to single cell WGA, and was successfully applied in several subsequent applications.13-14 A variant of the DOP PCR, developed by Rubicon Genomics, was used to amplify single chromosomes,15 a feat very shortly followed by the use of a linker-adaptor PCR method to completely amplify a single chromosome.16 Finally, MSD with phi29 was used to amplify a series of single cells.17 WGA methods differ in two respects: the amount of bias in the product when using limited amounts of input template and the quality requirements for the input template. The former issue, which in single cell applications manifests itself as apparent loss of information or allelic drop out (ADO), is thought to be due to inequities of local distribution of the reagents near the target.18 The latter phenomenon is dependent on the method, and the fact that damaged DNA can make certain loci unamplifiable. WGA methods that generate long amplicons like MSD, can be less robust because priming events are necessarily few and therefore any error in a long amplicon causes a relatively large loss of information. WGA that generates short amplicons such as P E P PCR, linker-adaptor amplification and DOP PCR lose less information in such circumstances. Both DOP PCR and MSD amplification are now available in commercial molecular biology kits, some of which have been developed specifically for single cell applications. At the heart of this product line is a PCR-based WGA method that employs degenerate oligonucleotides coupled with universal adaptors in a combination of P E P and DOP amplification methods. One commercially available single cell WGA kit can produce a million-fold amplification of a flow-sorted or laser microcaptured single cell resulting in approximately 5µg of final yield.29 Advances in single cell WGA will allow researchers to uncover the contribution of genomics to single cell biology. Specifically, cancer and drug discovery research within genomics shows the greatest potential. Chromosomal aberrations, as a result of cancer, could be better cataloged when comparing a single cancerous cell to its normal counterpart. In addition, comparing single cell from the 'treated' population to the 'untreated' to evaluate genomic effects can be used to screen drug candidates. Understanding differences at the level of a single cell is the ultimate goal of biology. New, commercialized techniques, such as single cell WGA, are opening a new frontier for further study. Considerable work has already been accomplished towards the sensitive, unbiased amplification of single cell RNA to allow single cell expression7, 22-27 and this area has already seen the development of commercialized kits to respond to this customer need. As researchers continue to find sensitive means to explore epigenetics, proteomics,18,19 metabolomics and cell signaling,20,21 the whole world of single cell biology will be revealed. References: 1 Reyes F, et al., (1976) The heterogeneity of erythrocyte antigen distribution in human normal phenotypes: an immunoelectron microscopy study, Br J Haematol., 34(4), 61321 2 Cheung SW, et al., (1977) Gene mapping by fluorescent in situ hybridization, Cell Biol Int Rep., 1(3), 25562 3 Mariani BD, et al., (1984) Gene amplification in a single cell cycle in Chinese hamster ovary cells, J Biol Chem., 259(3), 190110 4 Lange, BM, (2005) Single cell genomics, Curr Opin Plant Biol., 8(3), 23641 5 Liu WT, et al., (2005) Environmental microbiology on a chip and its future impacts, Trends Biotechnol., 23(4),1749 6 Diks SH, et al., (2004) Single cell proteomics for personalized medicine. Trends Mol Med., 10(12), 5747 7 Subkhankulova T, et al., (2006) Comparative evaluation of linear and exponential amplification techniques for expression profiling at the single cell level. Genome Biol., 7(3), R18 8 Paul P, et al., (2005) Single molecule dilution and multiple displacement amplification for molecular haplotyping, Biotechniques, 38(4), 5539 9 Ludecke HJ, et al., (1989) Cloning defined regions of the human genome by microdissection of banded chromosomes and enzymatic amplification. Nature, 338(6213), 34850 10 Zhang L, et al., (1992) Whole genome amplification from a single cell: implications for genetic analysis. Proc Natl Acad Sci USA, 89(13), 584751 11 Dean FB, et al., (2001) Rapid amplification of plasmid and phage DNA using Phi 29 DNA polymerase and multiply primed rolling circle amplification. Genome Res., 11(6), 10959 12 Telenius H, et al., (1992) Degenerate oligonucleotide primed PCR: general amplification of target DNA by a single degenerate primer. Genomics, 13(3), 71825 13 Barrett MT, et al., (1995) Genotypic analysis of multiple loci in somatic cells by whole genome amplification, Nucleic Acids Res., 23(17), 3488â€“3492 14 Snabes MC, et al., (1995) Preimplantation single cell analysis of multiple genetic loci by whole genome amplification. Proc Natl Acad Sci USA, 91(13), 61815 15 Gribble S, et al., (2004) Chromosome paints from single copies of chromosomes, Chromosome Res. 12(2), 14351 16 Thalhammer S, et al., (2004) Generation of chromosome painting probes from single chromosomes by laser microdissection and linker adaptor PCR, Chromosome Res. 12(4), 33743 17 Hellani A, et al., (2004) Multiple displacement amplification on single cell and possible PGD applications. Mol Hum Reprod., 10(11), 84752 18 Irish JM, et al., (2006) Mapping normal and cancer cell signaling networks: towards single cell proteomics. Nat Rev Cancer, 6(2), 14655 19 Hellmich W, et al., (2005) Single cell manipulation, analytics, and labelfree protein detection in microfluidic devices for systems nanobiology. Electrophoresis, 26(19), 368996 20 Irish JM, et al., (2004) Single cell profiling of potentiated phosphoprotein networks in cancer cells. Cell, 118(2), 21728 21 Krutzik PO, et al., (2003) Intracellular phosphoprotein staining techniques for flow cytometry: monitoring single cell signaling events. Cytometry A., 55(2), 6170 22 Ginsberg SD, (2005) RNA amplification strategies for small sample populations. Methods, 37(3), 22937 23 Kurimoto K, et al., (2006) An improved single cell cDNA amplification method for efficient high-density oligonucleotide microarray analysis. Nucleic Acids Res., 34(5), e42 24 Van Gelder RN, et al., (1990) Amplified RNA Synthesized from Limited Quantities of Heterogeneous cDNA. Proc Natl Acad Sci USA, 87,16631667 25 Dixon AK, et al., (2000) GeneExpression Analysis at the Single Cell Level. Trends Pharmacol Sci, 21, 6570 26 Ginsberg SD, et al., (2004) Single Cell Gene Expression Analysis: Implications for Neurodegenerative and Neuropsychiatric Disorders. Neurochem Res, 29,105364 27 Levsky JM, et al., (2002) Single Cell Gene Expression Profiling. Science, 297,83640 28 Findlay I, et al., (1995) Allelic dropout and preferential amplification in single cells and human blastomeres: implications for preimplantation diagnosis of sex and cystic fibrosis. Hum Reprod., 10(6),160918 29 Brueck, C. Brown, S. Michalik, D. Vassar-Nieto, E. Mueller and G. Davis. Single-Cell Whole-Genome Amplification. 2007. CSHL Press. Genetic Variation: A Laboratory Manual: 136-139. ]]> <![CDATA[Bio-outsourcing holds promise for India]]> https://biospectrumindia.com/news/95/2874/bio-outsourcing-holds-promise-for-india.html https://biospectrumindia.com/news/95/2874/bio-outsourcing-holds-promise-for-india.html Fri, 06 Nov 2009 15:56:00 +0530 Bio-outsourcing holds promise for India An increasing number of global biopharmaceutical companies are outsourcing biomanufacturing  (bio-outsourcing) to bring their products to market in a cost-effective and timely fashion This article explores the pros and cons of bio-outsourcing and provides some insight into the prospects for future growth of this newly emerging industry both globally and from an Indian perspective. During the past 25 years, the biopharmaceutical industry has transformed itself from a research and development enterprise into a robust, product-driven sector of the global economy, with worldwide sales of biopharmaceutical products topping $80 billion (about Rs 3.76 lakh crore), an estimated 174 approved products, and 800 plus  products in various stages of clinical development. Historically, biopharmaceutical companies have chosen to bring biomanufacturing ‘in-house’ to retain control over personnel, production schedules, intellectual property (IP), and regulatory and quality concerns.  However, many smaller companies do not possess the internal expertise or the financial resources to manufacture their own products and they turn to contract manufacturing organizations (CMOs) for clinical or commercial production of their products. This helps those companies that are not equipped with expensive facilities.   Outsourcing of bio-manufacturing globally grew at annual rate of 20 percent for the last decade, and is expected to cross $4 billion (about Rs 18,837 crore) by 2011 from $2.8 billion (Rs 13,191 crore)  in 2008. What is Getting Outsourced? Two distinct philosophies have been seen to be at work. One trend has seen large companies outsource their clinical manufacturing, which requires flexible manufacturing facilities, uncertain quantities, and less focus on cost of goods, while they retained commercial manufacturing, where they could maintain control over cost of goods, consistent quality and reliability of supply. The growth of large, specialized CMOs has also seen a reverse trend, where the product companies retain their clinical manufacturing, which is tied into their core business of research and development, and outsource the routine job of commercial manufacturing, which they no longer see as their core competence. Biologics CRAMS in India India, with more than 80 US FDA-approved manufacturing facilities and efficient, low-cost production models resulting from the highly competitive domestic generic pharmaceuticals market, is one of the most preferred locations for outsourcing manufacturing by global pharmaceutical companies. The Indian pharmaceutical contract manufacturing market stood at $1.21 billion (about Rs 5,697 crore) in 2007, and is estimated to reach $3.16 billion (about Rs 14,878 crore) by 2010. Last year, India’s Biotechnology Industry grossed revenues of $2 billion (about Rs 9,420 crore) and is amongst the top countries in the Asia Pacific region.  Some of the active players in the biologics development and manufacturing space are Syngene, Biocon, Intas Biopharmaceuticals and  Avesthagen.  Other product companies such as Reliance Biopharma, Shantha Biotech, Panacea Biotec, Wockhardt and Dr Reddy’s are also eyeing contract manufacturing as the scales of operation become bigger and facility utilization and operational cost control become critical. As an industry we in India are moving from the ‘hundreds of litres’ to the ‘thousand-litre’ scale on the mammalian side and these scales become a good entry point for such bio-manufacturing opportunity. With the increasing titres of today’s expression systems, scales of a 1,000L are likely to be adequate for a great proportion of clinical as well as commercial requirements of future products. The size of the overall biologicals market in India will remain small due to the high cost of therapy as well as the changes in the IPR landscape, with the introduction of product patent regime. As a result, unlike the traditional pharmaceutical sector, the contract manufacturing business in biologicals may not piggyback only on the generic manufacturing capacity, but may develop as an independent business segment. The biosimilars (biogenerics) sector still has an important role to play, as it will demonstrate that high quality biologics can be manufactured in India, and it goes a long way towards establishing a critical mass of scientific, technical and engineering talent. Intas Biopharmaceuticals in the CMO business Intas Biopharmaceuticals Limited (IBPL) is bullish on the opportunity for contract development and manufacturing in India and has a dedicated business segment for pursuing this business. IBPL is India’s first and only biotechnology manufacturing facility EU-GMP certified by a European regulatory authority. It has the capability to meet requirements of small to medium scale GMP production microbial-as well as mammalian-derived products, including fill-finish of liquid and lyophilized products in syringes and vials. The company has expanded its Contract Research and Manufacturing Services (CRAMS) business with the acquisition of US-based biotechnology company, Biologics Process Development Inc., which is fulfilling the requirements of its clients in North America and Europe. A new facility under construction, meeting both US FDA and EMEA GMP requirements, will add 5000L of cell culture capacity for monoclonal antibody production. Contract Manufacturing in India: beating the slowdown There are ‘push’ and ‘pull’ factors that make outsourcing a prudent option. The ‘push’ factors are pressure on the company to reduce cost, time-to-market, and the ‘pull’ factors are proven track record of the CRAMS company to handle product development and comply with GMP as per international requirements. These are challenging times where the global financial crisis has affected many smaller biotech’s that may be forced to license out earlier than they would have liked to, while larger companies will be constrained in their ability to pursue the entire pipeline.  These ‘push’ factors combined with the ‘pull’ factor of companies such as Intas Biopharmaceuticals with demonstrated capabilities and the required scale could create significant opportunity to bring such development and manufacturing business to India. ]]> <![CDATA[Biological drugs making a difference]]> https://biospectrumindia.com/news/95/7258/biological-drugs-making-a-difference.html https://biospectrumindia.com/news/95/7258/biological-drugs-making-a-difference.html Fri, 06 Nov 2009 15:50:00 +0530 Biological drugs making a difference The biological drugs have an edge over their chemical counterparts when it comes to safety, and have been largely accepted by both the consumers and the medical community for safer and effective patient treatment These days, one cannot escape hearing the word, ‘biotechnology’ or ‘biological drugs’ while watching television, listening to a radio broadcast or reading a scientific magazine or a newspaper. One often wonders, “what has biotechnology got to do with the biological drugs, and why and how are they different  from the drugs we normally have been taken for years since the start of chemical revolution in early 1900s”? The answer lies in the biotech revolution that took roots in 1953 with the discovery of DNA structure by Watson and Crick, followed by the discovery of restriction enzymes and hybridoma technology two decades later, coupled with the invention of PCR in 1983. After that, nothing stopped the biological revolution which grew by leaps and bounds, and has given us several new and interesting biological drugs in the last two decades. These drugs not only have made a big difference in our lives but also offer better treatment options for patients than before. Let us first address the fundamental question, “What are biological drugs and how are they different from the normal drugs we are used to taking”? Biologicals or ‘protein based drugs’ use different proteins that occur naturally in any living organism, to diagnose, prevent and treat diseases and related conditions. Traditionally, proteins have been isolated from plant and human sources and used for alleviating diseases, but the advent of recombinant DNA technology has enabled large-scale production of these futuristic biological drugs to be developed for human health care. The major difference between biological drugs and chemical-based normal prescription drugs is that biological drugs are highly specific and work with almost ‘pinpoint’ accuracy to treat the diseased organs or cells that require treatment. This particular trait also makes them safer, with little side effects, when compared to chemical-based drugs. These drugs of the future are being developed through advanced technology called genetic engineering or recombinant DNA technology. Safe, effective healthcare is a key concern worldwide. The drug regulatory agencies across the globe keep safety of drugs as their primary agenda while evaluating new drug candidates. The biological drugs have an edge over their chemical counterparts when it comes to safety, and have been largely accepted by both the consumers and the medical community for safer and effective patient treatment. Biologicals’ mode of action Cytokines: These are proteins, peptides or glycoproteins that are secreted by specific cells of the immune system and carry signals locally between cells, and thus have an effect on other cells. The list includes lymphokines, interleukins and chemokines. Clotting factors: These are proteins that regulate the clotting of blood and help in maintaining internal homeostasis. These drugs are used to treat blood clotting disorders like hemophilia. Vaccines: These are proteins that provide immunity to a particular disease by stimulating the production of specific antibodies thereby, preventing or treating the disease. Monoclonal antibodies: These antibodies are monospecific antibodies and are so called because they are produced by one type of immune cell that are all clones of a single parent cell. These antibodies are very specific to their target such as cancer cells, disease-causing bacteria and viruses for their destruction by other components of the immune system. Bio-therapeutics: Proteins that interact to inhibit or augment the activity of disease causing enzymes/proteins. Few of the examples of biological drugs include insulin, G-CSF, Erythropoietin, GM-CSF and a variety of monoclonal antibodies for transplant rejection (Muronomab-CD3, Daclizumab, Basiliximab), cardiovascular disease (Abciximab) and cancer (Rituximab, Trastuzumab (Herceptin) Gemtuzumab ozogamicin, Alemtuzumab, Cetuximab and Bevacizumab). Monoclonal antibodies are by far the most used of all the biological drugs today. These antibodies have been made in such a manner that they can bind to a specific target and, thus, can be used to treat disease-specific cells and tissues in a safe and effective manner with fewer side effects. One of the initial disadvantages of therapeutic monoclonal antibodies was that they triggered immune reaction causing production of HAMA (human anti-mouse antibodies) in human subjectCellular Subscriber Bases. This was  because the monoclonal antibodies were made with mouse Fab and Fc region. However, this was overcome by the production of chimeric antibodies wherein the constant Fc portion was replaced with the human’s while keeping the hyper variable regions from mouse, thus reducing the immune reaction. Currently, fully humanized antibodies are also being developed for certain treatments although they are not required for all disease or disease related conditions. Are biologicals really safe? Although biological drugs present a safe and efficacious form of treatment, they suffer from a number of disadvantages. The disadvantages are: (i) higher cost compared to their chemical counterparts, (ii) batch to batch variability in production, (iii) drug delivery mechanism (mostly injectable) as they can’t be orally taken as chemical drugs and (iv) sometimes biological drugs have rare side effects that can be severe and life-threatening. What future holds? In spite of the disadvantages, biologicals present a gr eat promise for the future of medicine. These are drugs of the future. To the patient, one of the most important advantages of being treated with these biological drugs is the improvement in their quality of life.  The biggest concern of patients when it comes to healthcare is cost. Biological drugs are currently costly, but will and can become cheaper in future with the improvements in manufacturing capabilities by enhancing production and eliminating downstream process purification steps. The recognition of these drugs’ potential benefits has put them on the fast track for FDA approval. The day is not far when biologicals would overtake their chemical counterparts in terms of the number of drugs approved and being in use. The Indian scenario The development of biologicals in the western world is on the fast track. India needs to wake up to this challenge and start investing in new drug discovery in the area of biologicals. India has been a successful generic player in the field of small molecule drug discovery, and is currently focusing on development of biogenerics or biosimilars versions of the proprietary biological drugs. If India does not want to miss the biotech bandwagon, we (the industry, academia and the government) should seriously get together and start the process of identifying and developing novel bio-therapeutics. This is not only to put India on the map of new drug discovery but also to develop cost-effective treatments for our own country. We at Premas Biotech are trying in a small way to help in this cause. Premas has invested in and developed a platform technology to discover novel biological drugs for Alzheimer’s disease and cancer. This technology is available for exploitation by pharma and biotech companies to develop novel biologicals.  ]]> <![CDATA[Biologics with a greater reach]]> https://biospectrumindia.com/news/95/4369/biologics-with-a-greater-reach.html https://biospectrumindia.com/news/95/4369/biologics-with-a-greater-reach.html Fri, 06 Nov 2009 12:12:00 +0530 Biologics with a greater reach Advent of biotechnology saw the introduction of recombinant biologics, where the DNA sequences coding for specific therapeutic proteins were introduced into bacterial, yeast or mammalian cells which multiplied and produced the biopharmaceutical protein product Biologics, broadly defined as products of living organisms for diagnosis, prevention or treatment of disease, have been around for over a century. The initial therapies ranged from anti-toxins (e.g. diphtheria and tetanus) to heat-inactivated vaccines. Biologics, regulated under Section 351 of the Public Health Service Act (PHSA) are defined as “a virus, therapeutic serum, toxin, antitoxin, vaccine, blood component or derivative, allergenic product, or analogous product, applicable to the prevention, treatment, or cure of a disease or condition of human beings.” Analogous products include: protein products (cytokines, enzymes, fusion proteins and some hormones), monoclonal antibodies, and gene therapy products. In the US, since first biologics to be regulated were vaccines, they are licensed (via biologic licenses) under PHSA and not Food, Drug and Cosmetic Act (FDCA). Drugs and certain simpler biologics such as insulin and growth hormone are approved under Section 505 of FDCA. In the early days, therapeutic proteins purified from natural sources, including animal tissues, were also used as therapies to treat deficiency disorders (e.g. insulin deficiency and growth hormone deficiency). Progress in science and technology, increased awareness, and better regulatory systems led to the availability of improved biologics. Modern biologics The advent of biotechnology saw the introduction of recombinant biologics, where the DNA sequences coding for specific therapeutic proteins were introduced into bacterial, yeast or mammalian cells which multiplied and produced the biopharmaceutical protein product. They could be loosely viewed as second generation or follow-on products of therapeutic proteins that were earlier being purified from natural sources. The first recombinant therapeutic product was Eli Lilly’s insulin, Humulin, approved in 1982. More than 250 biotechnology derived medicines have been licensed for use in humans, and many more are in preclinical and clinical development. These include, simple peptides and proteins as well as more complex therapies like monoclonal antibodies, fusion proteins and cell based therapies. Biopharmaceutical products versus small molecule drugs Biologics or biopharmaceutical drugs are large, complex molecules, produced in living cells. When compared to conventional small molecule chemical drugs, even simple proteins are 100 to 1,000-fold larger and more complex. Some of the more complex proteins and monoclonal antibodies undergo post-translational modifications resulting in the addition of carbohydrates or lipids to the protein component, contributing to heterogeneity and differences in immunogenicity. The molecules can also adopt different secondary and tertiary structures beyond their primary amino acid sequence. The methods of production of biologics are more capital-intensive and complex, and the products are more difficult to characterize, resulting in increased costs in bringing the product to the market. This is partly the reason why biologic medicines are in general much more expensive than chemical drugs. One estimate puts the average cost of a biologic drug treatment at $72,000/year  (Rs 33.94 lakh) when compared to approx. $1,000/year (Rs 47,150) for a chemical drug. Global sales of biologics in 2008 was $120 billion (Rs 5.65 lakh crore), of which monoclonal antibodies contributed $33 billion (Rs 1.55 lakh crore), vaccines $24 billion (Rs 1.13 lakh crore), TNF blockers $18 billion (Rs 84,860 crore), insulins (including newer inhaled insulin) $12.5 billion (Rs 58,900 crore), erythropoietins for anemia $9.5 billion  (Rs 44,790 crore)and interferons $8 billion (Rs 37,700 crore). Biosimilars and follow-on biologics The high costs of biologics and patent expiry of some of the older recombinant protein molecules created opportunity for companies to produce copy-cat versions of the molecules. Unlike for small molecule drugs, a regulatory framework for the introduction of generic versions of a biologic after patent expiry did not exist until recently. Biologics are produced by a complex process involving living cells, e.g. E. coli, yeast or mammalian cells. The specific clones or strains that are used to produce the innovator’s molecule are proprietary and not available for others. Therefore, it is nearly impossible that one will be able to produce and prove that generic copies of the innovator’s molecule are identical to the reference molecule, even with extensive analytical and pre-clinical evaluation. Therefore, the European Medicines Agency (EMEA) has used the term ‘biosimilars’ (similar biological medicinal products) instead of biogenerics to describe them, and adopted a new directive to pave way for legal approval of biosimilars in EU in 2004. In the US, the term follow-on biologics (FOB) or follow-on protein product (FOPP) is being used but it may be some time before a regulatory path for their license/approval is established. Even in Europe, biosimilars are being evaluated on a case-by-case basis since different classes of molecules may require specific guidelines for establishing comparability/similarity in quality, efficacy and safety. Some of the biosimilar medicines that have been approved for use in Europe are listed in the table on page 25. In 2006, Omnitrope was found to be structurally identical to Pfizer’s Genotropin and it was approved through 505(b)(2) pathway as a new drug application under Hatch-Waxman Act. Though Omnitrope is available in the US market, it is not rated AB like most generics and is not technically a biosimilar. Are all biosimilars truly similar? Human growth hormone and insulin are much simpler molecules and are much easier to test when compared to more complex molecules like erythropoietin and monoclonal antibodies. Monoclonal antibodies are more complex and have multiple domains that may play a critical role in clinical activity of the molecule. Additionally, one monoclonal antibody may be indicated in multiple diseases. Different combination of multiple activities may be required for being efficacious in each indication. Variation in glycosylation and immunogenicity are also major concerns with regard to establishing comparability of monoclonal antibodies. There have been debates in the recent years over how much clinical testing is required for a biosimilar, and how much and to what extent clinical data is necessary for marketing approval. Most regulators and innovator companies maintain that zero-tolerance to patient safety should be the standard approach. They contend that it is impossible to truly evaluate the immunogenicity or potential for adverse events in proteins without using proven clinical methods. One could also argue that with the progress in science and technology, it should be possible to develop better processes and better products than the existing innovator’s patented process. Therefore, it is also possible that all biosimilar molecules may not prove to be as good as or better than the innovator’s molecule. Careful evaluation of each molecule with regard to its comparability, safety and efficacy will be needed. For instance, EPO from Sandoz has received the same INN (international non-proprietary name) as that of the original Epogen from Amgen (EPO-alpha) while Stada’s biosimilar EPO received the INN of EPO-zeta and is not interchangeable with Epogen. Biosimilars are here Since biologic drugs are often used to treat life-threatening diseases, and are unaffordable to the vast majority of people in the world, the availability of good quality biosimilars at an affordable cost is a boon to many. Companies in India, China, South Korea and Europe have grabbed the opportunity and brought biosimilars to the market at cheaper prices. Health Canada maintains that no true biogenerics exist and uses the term subsequent entry biologics (SEBs) to refer to biosimilars. Canada and Japan are still working on a comprehensive regulatory framework for SEBs or biosimilars, and the US may not be far behind. A great opportunity is likely just around the corner for Indian biopharmaceutical companies that can keep the cost of development down while maintaining or improving the quality of their biosimilar products.  ]]> <![CDATA[Different people but less differentiated drugs]]> https://biospectrumindia.com/news/95/2358/different-people-but-less-differentiated-drugs.html https://biospectrumindia.com/news/95/2358/different-people-but-less-differentiated-drugs.html Fri, 06 Nov 2009 11:13:00 +0530 Different people but less differentiated drugs A drug can be highly effective for one patient but, the same drug might not show the desired result when given to a second patient with the same diagnosis and even be harmful in a third one Today half the medicines fail to produce the desired effect; only around half of all patients actually benefit from their drug treatment. This situation particularly is unsatisfactory for patients or doctors because neither the desired effects nor the side effects can be clearly defined or reliably calculated; and it is unsatisfactory for health insurers too, as they will be pay for treatments whose quality leaves a lot to be desired in many cases. This is where the concept of personalized healthcare steps in. What is personalized healthcare? Personalized healthcare (PHC) is about fitting treatment to patients to obtain better clinical outcomes. It is based on the concept that the treatment will be selected based on patient characteristics that become known through molecular diagnostic tests. PHC recognizes that we are all individuals and that the ‘one-size- fits-all’ approach is not effective. While a drug can be highly effective for one patient, the same drug might not show the desired results when given to a second patient with the same diagnosis and even be harmful in a third one. Based on the knowledge of disease biology, the mechanisms of actions of the drugs and the biological differences between patients as well as the characteristics of their disease, we are now able to tailor treatments and diagnostic tests to the needs of specific patient populations. It is a treatment tailored to specific needs of individual groups with shared features (eg., genetic characteristics), who can be grouped together in such a way that treatments can be optimally tailored to their needs. The approach of PHC is to use new molecular insights and molecular diagnostic tests to better tailor medicine and better manage disease. Potential of PHC Conventional medicines have traditionally been prescribed on a ‘one size-fits-all’ ‘trial-and-error’ basis, that is effective about half the time. This approach results in a large number of adverse drug reactions and misdiagnoses—which are in part responsible for approximately 200,000 deaths every year in the US alone. Today, response rates to treatments vary from 20-75 percent, depending on the drug and the disease. For that reason, patients and physicians are demanding better care and safer and more effective treatment. A century ago, blood cancers were known simply as ‘disease of the blood’. Today, cancers of the blood have been separated into 90 distinct leukemias and lymphomas, each with its own distinct therapy. Oncology Breast Cancer: One of the greatest advancement in the treatment of breast cancer is the drug, Herceptin, (trastuzumab) which targets HER2 positive breast cancer, a type of breast cancer that is known to be more aggressive. However, we know that not every patient responds to this treatment.Approximately 25 percent of breast cancer patients have HER2 gene over-expression. By measuring the presence of the growth factor, HER2, in breast cancer through a specific HER2 test can determine the HER2 positive beast cancer patients who will respond to Herceptin, therewith improving outcomes and reducing costs by treating only those patients who benefit. Colorectal Cancer: An excellent example of personalized healthcare at work is the KRAS mutation test.This test helps direct treatment for patients afflicted with metastatic colorectal cancer. Recently, scientists have developed more targeted therapies for colorectal cancer that look at limiting the growth of the cancerous cells. One such therapy is the epidermal growth factor receptor (EGFR) inhibitor (or anti-EGFR therapy), which prevents growth signals from entering the cells, thus stunting the growth of the tumor. Patients with a mutated KRAS gene (35 percent-45 percent of metastatic colorectal cancer patients) are unlikely to respond to EGFR inhibitors. With the TheraScreen KRAS mutation test, both doctors and patients will have a better idea on which treatment option to employ for greater effectiveness. Lung Cancer: The TheraScreen EGFR 29 Test designed to enable detection of 29 of the most common somatic mutations in the EGFR gene and detects mutations not visible by sequencing. Recent studies in non-small cell lung cancer (NSCLC) have shown that some patients carry somatic mutations in the EGFR gene. These mutations may correlate with responsiveness to the EGFR tyrosine kinase inhibitors, a targeted therapy for NSCLC. Virology HIV: The way in which HIV patients regularly test their viral load is one of the earlier examples of personalized healthcare. A patient will have their viral load tested (along with a CD4 cell count) when they are first diagnosed with HIV – this acts as a baseline. They are then tested again two-six weeks after they begin their treatment to evaluate whether therapy is effective. Subsequent tests are carried out every three to four months to monitor long-term therapy to ensure the patient has not developed a drug resistance. The advent of  tests has helped HIV turn from being an acute short term disease, to a chronic disease. HCV: Hepatitis is a viral infection that can go undetected in the body for years. Left untreated, it can lead to cirrhosis, liver failure and cancer. Detection and treatment are essential in the early stages when the likelihood of cure is relatively high. Tests that diagnose and monitor the virus in the blood and treatment with drug, Pegasys, have helped many of the people who have been infected. However, not all patients respond equally to this treatment. A HCV viral load test measures early response to therapy with drugs such as Pegasys, while a test that identifies Hepatitis C virus subtype provides information that helps to determine the correct duration of treatment with such medicines. A shorter treatment duration with Pegasys/Copegus will provide patients with full benefits of therapy while reducing unnecessary drug exposure. The four-month treatment course will be for patients with particular strains of chronic Hepatitis C (genotype 2 or 3) who have low virus levels before starting treatment, and who show a rapid virological response by clearing the virus from the blood within the first four weeks of treatment. This is a new treatment concept in Hepatitis C, which seeks to customize regimens for patients based on how well they respond to treatment. Metabolism Diabetes: Diagnostics provides blood glucose tests to tailor insulin treatment to patients’ needs. This is one of the first uses of personalized healthcare in modern medicine. Osteoporosis: A broad range of tests are made available to assess bone integrity and to monitor the effects of anti-resorptive therapy with drugs such as Bonviva/Boniva. They show response much earlier than bone mineral density. Further simple causes, such as Vitamin D deficiency is common in 60–70 percent of the Indian population. Drug Metabolism Now there is a pharmacogenetic test to analyze variations in two genes that play a major role in the metabolism of many widely prescribed drugs. This is the world’s first commercial pharmacogenetic product for predicting individual drug response that implements gene chip technology. Examples include drugs such as Warfarin. Transplantation Mycophenolate mofetil is an immunosuppressant to prevent the body from rejecting a kidney, liver or heart transplant. The key metabolite is mycophenolic acid (MPA). An immunochemistry-based test measuring MPA, guides optimal patient dosing. This enables doctors to accurately tailor these dosages and to safely lower dosages of more toxic agents, thus further improving the outcome for patients. Medical science continues to achieve rapid significant advances in treating patients. Understanding how patients are different and respond differently to a medicine is fundamental to learning how to treat disease at the right time and with the right medicine.  ]]> <![CDATA[Jury picks BioSpectrum 2009 awardees]]> https://biospectrumindia.com/news/95/7265/jury-picks-biospectrum-2009-awardees.html https://biospectrumindia.com/news/95/7265/jury-picks-biospectrum-2009-awardees.html Fri, 06 Nov 2009 11:07:00 +0530 Jury picks BioSpectrum 2009 awardees The Jury for BioSpectrum Awards 2009 met on October 23, 2009 at Dr Samir Brahmachari’s office at CSIR headquarters in New Delhi. In keeping with the BioSpectrum tradition, BioSpectrum Person of the Year 2008 chaired the publication’s 2009 Awards Jury.  In the one-and-a-half hour meeting that followed the jury deliberated on tough decisions. The Jury: Dr Rajiv Bhat, Prof & Dean, School of Biotechnology JNU; Narayanan Suresh, group editor, BioSpectrum; KV Venugopalan, president, Waters India; Dr Jasmin Patel, managing director, Fidelity International; Dr Samir Brahmachari, DG-CSIR; Dr BV Ravikumar, CEO, XCyton Diagnostics; E Abraham Mathew, chief editor, BioSpectrum. ]]> <![CDATA[Bt brinjal on the horizon]]> https://biospectrumindia.com/news/95/1010/bt-brinjal-on-the-horizon.html https://biospectrumindia.com/news/95/1010/bt-brinjal-on-the-horizon.html Fri, 06 Nov 2009 11:05:00 +0530 Bt brinjal on the horizon In a historic move, India’s biotech regulators approved the country’s first biotech food crop, a variety of Bt aubergine or eggplant. It was developed by Monsanto’s Indian joint venture partner, Mahyco The India biotech crop economy is expected to be further boosted as the national biotech regulatory agency, the Genetic Engineering Approval Committee (GEAC), gave its approval to the commercial cultivation of the country’s first genetically-modified (GM) food crop, brinjal (aubergine) variety, amidst widespread protests by anti-GM activists. This will be the country’s and world’s first approval of Bt brinjal variety. The commercial cultivation, however, is on hold for some more time. Though the GEAC has approved the commercial use of the Bt brinjal, things are still hazy on its likely date with the customer’s plates. For the environment minister, Jairam Ramesh, has embarked on another long public consultative process before giving the final go ahead for commercial cultivation. Brinjal is crucial to India’s Rs 72,000 crore vegetable economy. Currently, India is the second largest grower of brinjal in the world after China with 26 percent market share. China is ahead by four percent. More than 40 percent of the India’s brinjal crop is lost to pest attacks. The Bt brinjal could minimize this loss to single digits and make the country the world’s largest grower of brinjal, the “poor man’s vegetable.” Similar controversies were raised against the introduction of Bt cotton and Indian farmers lost four or five crucial years by the delay. Will Bt brinjal go the same way and Indian farmers end up paying the price in terms of lost incomes? The Bt brinjal technology, developed by Monsanto, was taken up by Mahyco and two public institutions— The Tamil Nadu Agricultural University (TNAU), Coimbatore and University of Agricultural Sciences (UAS), Dharwad, Karnataka.  In addition, scientists at Cornell University, US, and scientists in the University of Philippines and Bangladesh Agricultural Research Institute (BARI) were also involved in the development of the technology. Technology march Bt brinjal was developed by transforming the brinjal proprietary line of Mahyco. According to MK Sharma, managing director, Mahyco Monsanto, the Bt brinjal contains three genes inserted via genetic engineering techniques. First, the Cry1AC gene, which encodes for an insecticidal protein Cry1AC, was derived from the common soil bacterium Bacillus thuringiensis subsp. kurstaki (B.t.k). The Cry1AC gene is driven by enhanced CaMV 35S promoter. Second, the NPTII gene, which encodes the selectable marker enzyme neomycin phosphotransferase II (NPTII), was used to identify transformed cells that contained the Cry1AC protein. It has no pesticidal properties. The NPTII gene is derived from the prokaryotic transposon Tn5. The third one is the AAD gene, which encodes for the bacterial selectable marker enzyme 3”(9)-O-aminnoglycoside adenyl transferase (AAD), allowed for the selection of bacteria containing the pMON 10518 plasmid on media containing spectinomycin or streptomycin. The AAD gene is under the control of a bacterial promoter and hence not expressed in Bt brinjal. The AAD gene was isolated from transposon Tn7. The Bt Brinjal was produced using Agrobacterium-mediated transformation system. The Agrobacterium tumefaciens strain LBA4404 carrying the vector pMON 10518 (which carries Cry1AC, NPTII and AAD genes) was used in the transformation process. The T-DNA, which includes Cry1AC, NPTII, and AAD genes, was transferred into the genome of the brinjal cells. The  seeds of a proprietary line of Mahyco were used as source material for brinjal transformations. After the genes were introduced by Agrobacterium-mediated transformation, transgenic plants were regenerated by tissue culture, using kanamycin as the selection agent. The development of an improved method for Agrobacteriummediated brinjal transformation was done at Mahyco. The plants, regenerated through tissue culture procedures on media containing kanamycin, were analyzed using ELISA for the presence of Cry1AC protein. The plants expressing Cry1AC proteins were carried forward and analyzed in subsequent generations to identify lines, in which the transgene segregated in the expected Mendelian fashion. Selected lines were also analyzed by southern blot. A single line (event EE-1) was introduced into the breeding program. A PCR based event ID was developed by Mahyco for this unique event EE-1. The Cry1AC gene in the transgenic Bt brinjal behaved as a single dominant Mendelian factor indicating stable inheritance of the gene in the plant genome. To be active against lepidopterans insects (brinjal fruit and shoot borer; fruit borer) the protein must be ingested. In the insect gut, the protein binds to specific receptors on the insect midgut, inserts into the membrane and forms ion-specific-pores. These events disrupt the digestive processes and cause death of the insect. “The Cry1AC protein produced in Bt brinjal is non-toxic to non-lepidopteran insects, birds, fish and mammals as these species lack receptors for the proteins on the surface of their gut cells. The acidic medium in gut of these organisms also makes Cry1AC protein inactive. NPTII and AAD proteins are used as a selectable marker and have no pesticidal activity and are not known to be toxic to any species,” said C Kameswara Rao, founder of the Foundation for Biotechnology Awareness and Education. Trials Extensive field trials were carried out in Karnataka, Goa, and Maharashtra at five places. Six popular varieties — Kudchi, Malapur, Udupi, Gulla, Rabakali, and Goa 112 — cultivated locally were modified genetically and used in the field trials. The stormy atmosphere created by anti-GM activists did not deter the GEAC decision with only three of the 28 members opposing the commercial release of Bt brinjal variety. Brinjal is one of the few food crops which is believed to be native to the Indian subcontinent. This crop, Solanum melongena L, known as brinjal or baingan in India and eggplant/aubergine elsewhere is important to the country’s economy. This highly nutritious, low fat, egg shaped product is consumed widely in the country. Also, brinjal is the second largest vegetable crop grown in India after potato accounting for 11 percent of the annual vegetable production of 81 million tonnes. Just four percent of India’s cultivable land area of 166 million hectares is used for vegetable production. India ranks first in the world in the production of okra (lady’s finger) and second in cabbage, cauliflower, eggplant, peas, onion and tomato. In potatoes, India ranks third globally in annual production. However, except in the case of tomato, India’s average yield per hectare for the most commonly cultivated vegetables is 20 to 30 percent lower than the world average figures. So technological inputs are crucial to reduce losses due to pest attacks and improve yields significantly. Mahyco’s R&D under the guidance of the Department of Biotechnology and the Ministry of Environment and Forests (MoEF), conducted multi-location field trials regularly from 2004 to 2006 to evaluate the efficacy of Bt brinjal in controlling brinjal fruit and shoot borer. Also, the Indian Council of Agriculture Research, New Delhi, independently conducted field trials of Bt brinjal, using its own protocol, under the aegis of AICRP (VC) during Kharif seasons of 2004-05 and 2005-06. The approval of protocols and supervision of trials conducted by Mahyco were assigned to a Monitoring and Evaluation Committee (MEC). Various teams of experts nominated by MEC regularly visited these trials and submitted reports about these trials to RCGM/GEAC through MEC. These trials were generally aimed to assess insect reactions, yield parameters, insecticide usage, and the economics of Bt brinjal. Fruit harvested from Bt brinjal plants of the Mahyco hybrids were evaluated for their physical characters including shape, size and color. These observations were made at green house level, in field at 11 different locations during Kharif 2004 and six different locations during Kharif 2005 season. No differences were observed between Bt and non-Bt brinjal fruit with respect to shape, size and color. Further, the Bt entries suffered significantly less damage due to pest when compared with the check and yielded higher number of marketable fruits. Brinjal economy India’s brinjal economy is estimated to be close to $2 billion (Rs 9,600 crore) with 1.4 million farmers cultivating it annually in nearly 550,000 hectares (1.4 million acres). Area under brinjal cultivation has grown by 15 percent in the last 10 years but the production has barely increased by 9 percent. A major factor is the repeated attacks by the insect Leucinoda orbonalis or fruit and shoot borer (FSB) which increases the input costs and keeps the production down. So far India has approved only a single GM crop, Bt cotton, which was allowed to be cultivated commercially in 2002. The runaway success of Bt cotton, more than 85 percent shifting to this GM variety, within years of its introduction has definitely influenced the government decision. India’s Bt cotton production has more than doubled to more than 3.1 million bales (of 170 kg each) in the last five years. The annual value of the biotech cotton crop, based on the sale price of Bt cotton seeds in 2008-09 was estimated to be Rs 1,500 crore by BioSpectrum. India’s farmers are quick to adapt modern technologies and the success story of Bt cotton is also likely to be repeated in the case of Bt brinjal too and Bt brinjal seed companies could expect annual seed sales in excess of Rs 500 crore in the next few years. More importantly, now almost 40 percent of the brinjal production in the country is destroyed by the FSB pest. Adoption of Bt brinjal could reduce the waste considerably and brinjal farmers could expect to rake in additional Rs 3,600 to Rs 4,000 crore annually from product sales. The approval to Bt brinjal was given at a meeting of the GEAC in the Ministry of Environment and Forests in New Delhi on October 14. The decision has to be ratified by the MoEF and notified in the government gazette and licensing arrangements worked out with the technology developers. The regulatory approval will mark a new beginning for India’s $300 million, biotech seed industry. Nearly a dozen Indian companies and agricultural research institutions have been developing 12 to 15 other GM crops. The regulatory barrier crossed by the country’s first biotech food crops will spur more action on this front. Kameshwara.gifhttp://biospectrumindia.ciol.com/images/content/2009/nov/ http://biospectrumindia.ciol.com/images/content/2009/nov/ Narayanan Suresh Transgenic Bt benefits The direct benefit of bt technology is the control of the most damaging pest of a particular crop, says C Kameswara Rao Technologies come with some concomitant and some consequential benefits, both of which should be taken together in assessing the total benefits that accrue. No technology is risk free. Benefits of a technology should hence be weighed against minimal and acceptable risks and a favorable cost-benefit ratio. Risk assessment, mitigation, and management are at the heart of regulatory processes. Planting a non-Bt refugium along with Bt crops is a means of mitigating the risk of acquired resistance, and so is gene stacking. The most direct and the most important benefit of Bt technology is the control of the most damaging pest of a particular crop, such as the American bollworm of cotton, stem borers of rice and corn, rootworm of corn, Colorado beetle of potato or stem and fruit borers of aubergine (brinjal). As systemic pesticides, Bt proteins take care of these pests (see Bt brinjal on the horizon, p. 14). The other pests, on which Bt proteins have little or no effect, need to be controlled by pesticide application, preferably as a part of Integrated Pest Management (IPM) practices. Bt technology imparts only tolerance of the targeted pest of a particular crop and not total resistance to it. In view of the variation in the expression of Bt genes, due to various internal and external factors, two or three pesticide applications are needed instead of the usual 10 to 20. Any crop should be grown under optimal conditions to obtain the best benefits from the new technology. In India, cotton is often grown under near impossible conditions, as farmers are lured into growing a cash crop, irrespective of the inappropriate infrastructure, and suffer disastrous consequences. In many developing countries, the record of both the advice given to the farmers and of farmers taking it seriously, is dismal. Some of the benefits of Bt technology are that it results in a healthy crop, with more biomass and more yield. It reduces risk to farm labor involved in pesticide application. It also results in lower concentrations of pesticide residues on the produce and in the environment. Most importantly, the Bt farmer experiences a sense of certainty of the yield with Bt technology than the earlier scenario of ‘spray and pray’. The Bt technology has no gene based influence on crop yield. And contrary to popular belief, the Bt technology does not cause or control any viral. The scenario for farmers can and will improve only when there are better yields which is possible with Bt technology, contrary to what anti-GM activists would ever want to let happen. ]]> <![CDATA[The right time for biotechnology]]> https://biospectrumindia.com/news/95/2312/the-right-time-for-biotechnology.html https://biospectrumindia.com/news/95/2312/the-right-time-for-biotechnology.html Thu, 05 Nov 2009 10:51:00 +0530 The right time for biotechnology Success  is all about timing. Being at the right place and doing the right thing is necessary of course, but if it is also at the right time then magic happens. We are in India, in biotechnology today in 2009 and magic is happening Q.E.D. I had the privilege of a recent conversation with Steve Burrill (of Burrill and Company) in which he pointed out that four out of the five global challenges today – healthcare, food security, energy security and environment – are directly addressed by biotechnology. So in the modern history of technology, biotechnology is poised very strategically. I would also argue that we are entering  an exciting period for the biotechnology enterprise in India. We have gone past the teething problems of a new industrial sector and the threshold of criticality in size and ecosystems. The voice of our enterprise is BioSpectrum and as the newly elected president of ABLE, it is with pleasure that I write this guest editorial. This special issue of BioSpectrum, dedicated to content created by the readers,  covers a lot of ground with a rich variety of topics that reflecting the diversity in our field. Three themes stand out. Biologics and in particular the emergence of biosimilars is an important one for our industry. Dr Gopal  Dasika of Actis Biologics  takes us on a global journey of the action in biosimilars with an account of companies in India, China, South Korea and Europe that are leveraging these new opportunities to good effect. The article by  Dr  Rajeev  Soni of Premas Biotech, complements the above article with a useful pedagogic account of the challenges in discovery of novel biologics.  The age of personalized medicine is coming and the agenda that biotechnology innovation has to deliver on presents spectacular opportunities. Dr Bhuwnesh Agrawal of Roche Diagnostics takes us on a historic tour of personalized medicine showing the central role that diagnostics plays in ensuring that safer personalized healthcare can deliver as opposed to a “one size fits all” blockbuster view of yesteryear. Several experts have noted that personalized medicine has been slow in coming because the market segmentation is a challenge that large pharmaceutical companies have resisted. I believe that resistance has passed now and the new mantra has taken root. Dr  Rajesh Jain of Panacea Biotec takes us through an understanding of why traditional pharma marketing efforts are nearly over. To a lay citizen, the field of biotechnology evokes awe because of the deep multi-disciplinary research investments it takes to bring out innovative products.  We get a sample of how materials research in academia is leading us to new ways of thinking about drug delivery and health monitoring. The paper by Sharath Ahuja is on the work on silica nanotubes by Dr Aninda J Bhattacharyya and team at the Indian Institute of Science in Bangalore. The issue also raises some immediate concerns for the sector of clinical research organizations in India that are facing a crisis of overcapacity. Dr  Sudhir Pai of Lotus Clinical Research Academy elucidates the issues  and suggests strategies to counter the challenges. In signing off, let me just add that as the executive council of ABLE  is keen to represent your interests and help you address  your challenges as the apex body of our industry. Please feel free to contact me personally or any of your elected council members if there is such an issue. Happy reading! Vijay Chandru CEO of Strand Life Sciences and president of ABLE, Bangalore  chandru@strandls.com  ]]> <![CDATA[Smiles again]]> https://biospectrumindia.com/news/95/1823/smiles-again.html https://biospectrumindia.com/news/95/1823/smiles-again.html Thu, 15 Oct 2009 14:25:00 +0530 Smiles again Things are beginning to look up for the Indian biotech sector. The interest level from investors has increased in recent months and key VCs (venture capitalists) are favorable to the sector again. Almost all the VCs BioSpectrum spoke to for the October issue cover story are positive about biotech's prospects in the medium and long term. This is certainly good news. More importantly, VCs who have their ears close to the ground agree that India's biotech companies are not lacking in innovation. They are only frustrated by the fact that not many of these innovative steps are maturing into the next stage of product development. Probably, a large pipeline will help as the nature of the industry indicates that the regulatory approval rate hovers around 5 percent globally. Two new product developments by Indian companies in recent months indicate the reasons for the optimism shown by VCs. A VC-funded starter, Premas Biotech, based in Gurgaon, has expanded beyond its role as a manufacturing services player, to develop a novel drug metabolism enzyme, part of the CYP P 450 suite of enzymes. With just 10 scientists, the company, led by Rajeev Soni, has developed this recombinant enzyme in less than two years. More remarkably, Premas has demonstrated the ability to scale up the product for mass production. Bangalore-based Bhat Biotech is the other company which has demonstrated its expertise in its niche segment. As the deadly Chikungunya viral fever rages in many parts of south India, Shama Bhat's company has quickly launched a test kit to detect the presence of the virus. The kit claims to detect the virus in three minutes, and is certainly a boon to medical practitioners and also chikungunya-hit patients as treatments can start early. Another heartening news is the major investment of around Rs 250 crore committed by Bangalore-based Kemwell to set up a large biological manufacturing facility in the city in collaboration with German biopharma manufacturing giant, Boehringer Ingelheim. Kemwell has specialized in contract manufacturing for more than 15 years and has demonstrated its expertise globally. In fact, Subhash Bagaria's Kemwell was one of the first to foray to Europe three years ago when it bought Pfizer's manufacturing unit in Sweden. The half-a-dozen biological manufacturing facilities run by companies like Biocon, Serum Institute, Shantha Biotech, Bharat Biotech, Panacea Biotec, Biological E are mostly for captive use. And so Kemwell is opening up another revenue stream for India's biotech sector. The signs of upswing are also visible when Avesthagen talks about its intention to restart its IPO activity. The IPO was postponed in 2008 as the stock market conditions turned for the worse. Of course, biotech has still a small share of the investments made in the country's life sciences sector. Pharma continues to get bulk (40 percent) of the investments, followed by healthcare (24 percent) and biotech gets about 13 percent. CROs get about 10 percent and the rest goes into many allied sectors. Meanwhile, the swine flu toll continues to mount. More than 200 Indians have succumbed to the virus which originated in Mexico and reached the national shores through air travelers. The indigenous vaccine developed by Serum Institute is undergoing further trial. The company showcased its first pilot vaccine in early September. Bharat Biotech and Panacea Biotec have also readied their products which are undergoing trials. Two foreign companies have announced their intention to conduct â€œbridge trialsâ€? in the country to speed up the vaccine's entry. Amidst all this action, the government has yet to formulate a vaccination strategy to minimize the impact of swine flu at least during the 2010 flu season. How many more swine flu deaths will spur the government in to action, is a questions citizens should start asking now. ]]> <![CDATA[Biocon, Amylin to jointly develop diabetes drug]]> https://biospectrumindia.com/news/95/6086/biocon-amylin-to-jointly-develop-diabetes-drug.html https://biospectrumindia.com/news/95/6086/biocon-amylin-to-jointly-develop-diabetes-drug.html Wed, 07 Oct 2009 15:58:00 +0530 Biocon, Amylin to jointly develop diabetes drug Indian biotech major, Biocon, and US-based Amylin Pharmaceuticals have entered into an exclusive agreement to jointly develop, commercialize and manufacture a novel peptide therapeutic for the potential treatment of diabetes.  Amylin and Biocon will collaborate to develop the therapeutic potential of the compound and share development costs. The research will center on Amylin’s ‘phybrid’ technology. A phybrid is a peptide hybrid molecule that combines the pharmacological effects of two peptide hormones into a single molecular entity. Under the terms of the development and commercialization agreement, Amylin will provide expertise in peptide hormone development, particularly in the area of phybrid technology, as well as metabolic disease therapeutics. Biocon will utilize its expertise in recombinant microbial expression to manufacture the compound and also leverage its experience in pre-clinical and clinical development of diabetes products. “This agreement fully leverages the synergistic capabilities of the two companies. Amylin’s knowledge of peptide therapeutics and their leadership in the diabetes market, paired with Biocon’s capabilities in process development, manufacturing and clinical development, provide this global program with the potential to effectively bring a novel therapy to patients living with diabetes,” said Dr Kiran Mazumdar-Shaw, chairman and MD, Biocon.” Daniel M Bradbury, president and CEO of Amylin Pharmaceuticals, said, “This program could unleash the potential of cutting-edge peptide science to transform the lives of patients with diabetes.” Redefine the frontiers of healthcare: CII conclave The two-day brain-storming conclave, Life Science Conclave 2009, organized by the Confederation of Indian Industry (CII) in New Delhi on August 27-28, 2009, featured six sessions and three panel discussions that were addressed by 62 eminent speakers. The issues debated in the conclave provided an opportunity for the Indian pharma and biotech industry to assess their position in becoming a major partner of the progress. Dinesh Trivedi, minister of state for health and family welfare, Government of India, while speaking at the conclave, stressed on the need for preventive measures rather than solely focusing on curative measures. Trivedi also stressed the need to strengthen diagnostic centers in the country acknowledging the frugal healthcare spending of the central government in the healthcare segment. Trivedi emphasized the need for a change in the international and national attitude, and mindset towards Indian healthcare as it continues to have the requisite knowledge and skills as well as the market. He also suggested a novel e-health card system to document the complete medical history of all citizens down to the village level. Dr VM Katoch, secretary, department of health research and director general, Indian Council of Medial Research, while speaking about India’s wealth of knowledge, underlined the need for removing the ‘bottlenecks’ to convert this knowledge into products with further industry and academic co-operation. He also stressed the need for further inter-ministerial co-operation among the various government departments. Citing the strategic importance of India in the pharmaceutical sector, Bruce Ross, country director, India, US Food and Drug Administration reiterated the US government’s commitment to continue its trusting relationship with regulatory counterparts in other countries, such as India. Ross said that India has the largest number of FDA approved drug manufacturers outside the US with Rs 6,708 crore ($1.38 billion) of exports to the US market in 2007–08 growing at 39 percent. Avesthagen to raise Rs 700 crore from markets Bangalore-based life sciences company, Avesthagen has revived plans for an IPO, and will raise about Rs 700 crore from the domestic and international markets. The funding will be used to commercialize 40 products, which are in various stages of development to market. Having initially announced the IPO last year, the company had to postpone the plans after markets fell due to global meltdown.  Dr Villoo Morawala Patell, founder and CMD, Avesthagen, said, “The IPO is slated to coincide with the time that our biosimilars are ready to hit the market place. From an investment perspective, I believe mid-2010 will see a global turnaround and a good business environment, such that all our stakeholders will benefit from investing in the company.”  Avesthagen, which currently holds 560 patents will be valued based on its patent and product portfolios. Avesthagen, which is expected to touch a turnover of Rs 100 crores this fiscal, is yet to decide on the bankers,  and would like to hold on to the promoter stake, which is currently at 32 percent while private equity (PE) players hold up to 28 percent. PE investors include ICICI Ventures, Fidelity and New York Life Investment Management India Fund.  Each of Avesthagen’s four strategic business units are expected to run as independent profit centers with dedicated management teams. Avesthagen has many products in the pipeline that need to be monetized and brought to the consumer. Recently, the company cleared one mammalian biosimilar monoclonal antibody product by the regulatory agency in India for clinical trials, and three other biopharma products have entered pre-clinicals. CHiCTR, CTRI to encourage clinical trials in China, India Pharma and biotech companies are attempting to combat escalating R&D costs and lengthy clinical trial timelines by improving patient recruitment, and the efficiency of clinical trial analysis/reporting. The biopharmaceutical market has recognized the opportunities and advantages that exist by conducting clinical trials in emerging markets. Although these markets offer a number of significant benefits over traditional clinical trial settings, there remain a variety of challenges and problems associated with conducting trials in emerging regions. Announcing the release of a report on ‘Emerging Clinical Trial Locations: Market Dynamics and the Changing Healthcare and Regulatory Environment’ by Business Insights noted that Russia is one of the world leaders in patient enrolment with an average patient recruitment rate in 2006 exceeded 4.7 patients per site per month. For some nosologies, this figure is 10 times higher than in Western Europe and the US. The Chinese Clinical Trial Register (CHiCTR) and The Clinical Trials Registry in India (CTRI) have helped to encourage all clinical trials in these regions to be registered before the enrolment of the first participant, and to disclose the mandatory 20 items of the WHO International Clinical Trials Registry Platform (ICTRP) dataset. By the end of May 2009, 895 clinical trials were registered in India, as against 150 clinical trial approvals in the year 2006 by the Drug Controller of India (DCI).  India is able to offer significant cost savings compared with clinical trials conducted in western countries. Phase I trials are approximately 50 percent cheaper than western equivalents, while phase II and phase III are 60 percent less expensive. The Chinese CRO market was valued at Rs 1,209 crore ($250 million) in 2008. The market is expected to grow at a CAGR of 33 percent over the next four years to reach Rs 3,825 crore ($791 million) in 2012. By that time, Chinese CROs will account for an estimated 2.3 percent of the global CRO market. India to monitor CROs closely In an effort to give a conducive business environment to CROs in the country the Indian regulatory agency has released draft rules for mandatory registration of all Clinical Research Organizations (CRO) across the country. Approved by the Drug Technical Advisory Board (DTAB), India, the draft guidelines are to standardize practices among such organizations and mandate strict adherence of standard operating procedures. The guidelines are not standalone and the objective is to improve overall quality of clinical trials by working hand-in-hand with other applicable rules, like Schedule Y, Indian GCP guidelines and Ethical Guidelines for Research on human subjects by ICMR. According to the draft made available to the public, the guidelines cover all organizations, individuals, institutions and companies that take the responsibility of initiation, management or coordination of a clinical trial. Thus, the draft rule makes it clear that the CRO can carry out its activities according to the contract with the sponsor, only if it is duly registered under the rules by the licensing authority. Before the organization registers, it needs to declare that the licensing authority has the right to inspect its premises at any given time and examine the process, procedure and documents of any trial taken care by the organization. ISO certification for Cryo-Save India Cryo–Save India, a part of Cryo-Save Group, Europe’s largest adult stem cell storage bank, achieved a significant milestone with TUV Rheinland, Germany, conferring the India operations an ISO 9001:2008 certification. TUV Rheinland, a leading quality management systems registrar from Germany, certified Cryo-Save India after examining the lab on various parameters. Cryo-Save India is dedicated to the highest quality standards and is the only company in its category to have received ISO 9001:2008 certification from TUV Rheinland, within such a short duration since commencement of its operations. The certification from TUV Rheinland helps to strengthen the processes and systems employed by Cryo-Save India, which include fully-automated systems that ensure no human intervention in storage and retrieval process along with a unique dual storage process. As part of the ISO 9001 process, TUV performed on-site assessments, examining the Cryo-Save India documention procedures and audited its overall operations. To determine continued compliance with ISO 9001:2008, TUV would conduct periodically scheduled audits at Cryo–Save India and examine and monitor its business operations. Quality Council of India, the authority in India for ISO-related standards, too can conduct random audits to verify organization’s compliance to declared practices. SIRO Clinpharm expands operations in Europe SIRO Clinpharm, a global Contract Research Organization (CRO) with its base in India, US, Europe and Israel, has opened its new office in Prague, Czech Republic. “Czech Republic has an excellent resource base of Good Clinical Practice (GCP) trained, well-qualified clinical research personnel. Our new office in Czech Republic will further strengthen our operational capabilities in Europe,” said Scott Spector, president, Strategic Operations, Europe. Dr Ladislav Pecen will be in charge of operations in Czech Republic for SIRO. To begin with, SIRO will roll out clinical monitoring, biostatistics and statistical programming services from the new office. From its offices in Offenbach, Germany, and Mumbai, SIRO has been offering these and other services like clinical data management, quality assurance, medical writing, medical affairs and pharmacovigilance for more than a decade. “We established our presence in Europe with the acquisition of Omega Mediation, a Germany-based CRO in April 2008. During the last 18 months, as a part of our global strategy, we have expanded our capabilities by opening offices in north east and south east Europe. We have already started eyeing other countries in Western Europe for further expansion,” said Dr Chetan Tamhankar, CEO of SIRO Clinpharm. MakroCare signs partnership with OmniComm Indian CRO MakroCare has partnered with OmniComm Systems, one of the fastest growing companies and a leader in integrated electronic data capture (EDC) solutions for clinical trials.  “MakroCare offers a best-of-breed suite of clinical technologies for managing global clinical trials, including customized interactive voice response (IVR) and web applications, comprehensive clinical trial management systems (CTMS) and drug safety and pharmacovigilance systems. The integration of the TrialMaster System into our clinical platform offers our customers an extremely powerful solution,” said Dr Rajeev Naithani, director, CDM. “Partnering with OmniComm allows CROs to offer their customers a first class EDC product and gives them a competitive edge in the bidding process,” said Stephen Johnson, COO of OmniComm. “It’s a win for everyone involved, the CRO, OmniComm and most importantly the clients that we serve.” With this partnership, MakroCare is entitled to use with the flexible, intuitive and robust EDC solution, TrialMaster. For clinical trials, a dedicated hosted environment and comprehensive training and support for TrialMaster. ]]> <![CDATA[Shimadzu launches Diamond Club in Asia]]> https://biospectrumindia.com/news/95/2816/shimadzu-launches-diamond-club-in-asia.html https://biospectrumindia.com/news/95/2816/shimadzu-launches-diamond-club-in-asia.html Wed, 07 Oct 2009 14:49:00 +0530 Shimadzu launches Diamond Club in Asia The membership of this elite club for leaders and partners in the industry is by invitation, and only the top one percent of Shimadzu’s customers qualify. After Indonesia, Thailand and Vietnam, Shimadzu has launched its Shimadzu Diamond Club (SDC) in India, the company’s most important market in the Asia Pacific region. The membership of this elite club for leaders and partners in the industry is by invitation, and only the top one percent of Shimadzu’s customers qualify for this elite group of customers, who will be offered a range of privileges including professional and organizational benefits.  The analytical instruments company, Shimadzu, is striving to become a global leader in the segment. The company believes that the way to achieve this is through valuable support and partnership with the customers—and not without a reason. In this tough year, the company has done well, thanks to its customers. Its overall installation base in India (split across instruments) has crossed 20,000. The concept of Shimadzu Diamond Club is an expression of the company’s appreciation to the continued support and encouragement from its customers. With this concept Shimadzu has taken yet another far-reaching step towards building a closer relationship with its key customers through extra-mile technical and commercial support.  Under the dynamic leadership of Tsuguo Kishida, MD, Shimadzu (Asia Pacific), Singapore the company in India is led by Senya Imamichi, MD, Shimadzu Analytical (India) and has been growing from strength-to-strength in its Asia Pacific operations. According to Imamichi, Shimadzu’s analytical business in India has witnessed a fast clip of growth in the last three years and the going will get only better from here. Given that Shimadzu’s HPLC sales in India crossed 10,000 units, the launch of Shimadzu Diamond Club was a celebration of many milestones. “Shimadzu along with its marketing partners has been serving the Indian analytical instrumentation market for close to four decades now. This is our way of reciprocating this support in a small way to our most important customers in India,” says Imamichi. In India, the company hosted the official launch ceremony of SDC in Bangalore, Mumbai and Hyderabad. Privileged members of the club attended the event and were introduced to the exclusive professional and organizational benefits that will be offered to them. Some highlighted benefits of this membership club include exclusive product discounts and trade-in proposals, priority application support, technical trainings, regular newsletter updates, participation in premier events in India and Japan and so on. For Shimadzu, the sales growth of HPLC has been much higher than any other instrument, especially in the last five years. Apart from HPLCs, Shimadzu has a base of approximately 50 LCMS, 2500 GCs and 450 GCMS. In India the installation base for the company instruments has crossed 20,000. In the foreseeable future, the company is aiming at launching a new product every quarter or half year.  BioSpectrum Bureau ]]> <![CDATA[â€œMultiple buyers are needed for maximum sensitivity, specificityâ€?]]> https://biospectrumindia.com/news/95/1471/multiple-buyers-are-needed-for-maximum-sensitivity-specificity.html https://biospectrumindia.com/news/95/1471/multiple-buyers-are-needed-for-maximum-sensitivity-specificity.html Wed, 07 Oct 2009 14:30:00 +0530 “Multiple buyers are needed for maximum sensitivity, specificity” —Dr Jehangir Mistry, director, R&D, Bioscience Division, Millipore Corporation, US Dr Jehangir Mistry is the director, R&D, Bioscience Division, Millipore Corporation, US. He leads Millipore’s Protein Research Assays Group, and also has extensive experience as director of manufacturing, director of automated systems and member of a business development team in his earlier assignment. In an interaction with BioSpectrum, Dr Mistry speaks about the gaining popularity of protein immunoassays in protein research and drug discovery, developments and trends. What is the importance of biomarker immunoassays in life science industry? Biomarker immunoassays are becoming very popular for the measurement of biologically important proteins that are either involved in the etiology or could serve as markers of various diseases. How can we address the challenges posed by these diseases? Diseases such as diabetes, cardiovascular diseases, infectious diseases and cancer are of particular relevance for Indian researchers and drug manufacturers, given the wide footprint of these diseases among Indians. Other diseases include: autoimmune diseases, neurological diseases (e.g; Alzheimer’s or Parkinson’s), toxicity and others. Major pharmaceutical companies as well as many academic clinical research centers are focused on identifying proteins that would serve as biomarkers for the purpose of either prognosis, diagnosis, monitoring drug efficacy, patient stratification, or risk assessment. These proteins either circulate in the blood or are present inside the cell. How does Luminex xMAP technology fit in here for protein biomarkers? The MAP stands for Multiple Analyte Profiling and x stands for any analyte of interest. The Luminex technology is based on polystyrene or magnetic beads, which are 6 micron in size. Luminex created 100 (now 500) different sets of beads, each set having a unique fluorescent signature. Each bead set can be used to conjugate an antibody to the specific analyte of interest. The second antibody is biotin-labeled and forms a ‘sandwich’ where the analyte binds between the two antibodies. Streptavidin-phycoerythrin (SA-PE) then binds to the biotin-labeled antibody. One can set up a multiplex immunoassay by mixing various bead sets of interest to measure specific analytes in a 96-well microtiter plate as if setting up an ELISA.  At the end of the immunoreaction, the plate is inserted in the Luminex reader, which has two lasers. The red laser identifies the bead set and also the analyte. The green laser quantitates the amount of fluorescence present on the SA-PE attached to the specific biotin-labeled detection antibody, and thus quantitates the amount of analyte. Millipore has strategically partnered with Luminex where it uses the xMAP technology to develop, manufacture and commercialize multiplex immunoassay kits for a broad range of protein biomarkers involved in various diseases or research areas. What are the benefits and applications of protein multiplexing? The major benefits of multiplexing include: lot more information at a much faster rate; conservation of precious biological samples; and reduced cost of analysis due to the reduction in labor, time and the cost of reagents. The xMAP technology has several advantages over other existing multiplex technologies such as planar arrays. The Luminex beads are robust, easy to handle,  and are easy to couple with antibodies. The major benefit of the Luminex technology is the flexibility of measurement of only the analytes of interest by mixing only those bead sets to which antibodies to the specific analytes are conjugated. Thus, the cost per analyte per sample is usually lower with the Luminex technology compared to the planar array containing a large number of analytes. How does Millipore support outsourcing? Millipore not only provides the multiplex immunoassay kits to the customers who already have the Luminex reader to run the kit in-house, but also offers to run samples, and provide results for a fee to those customers who either may not have the Luminex reader or are not familiar with the technology, or simply may not want to invest in resources to run the kit in-house. What are the significant developments and trends in protein research worldwide? The core applications today for protein multiplexing include: studying inter-relationships among biomolecules of similar function, structure or tissue origin; for example, cytokines and hormone analysis; elucidating intra-cellular signal transduction pathways, and related biological mechanisms to understand disease pathophysiology. The next frontier for multiplexing includes biomarker analysis and validation.  The fundamental concept is that multiple biomarkers are needed for maximum sensitivity and specificity. A significant amount of research is currently being done to evaluate the molecular fingerprint of multiple markers with the most predictive value. Where does India figure in the adoption of these developments and trends? India has been making tremendous progress in science and technology, and has attracted most foreign companies to invest in it due to its highly educated and talented workforce.  Several Indian companies and academic institutes have either already adopted the multiplexing technologies or are seriously considering it. I am glad to be a part of the Millipore India team to help our customers guide in making the decision of using the right technology that meets their research needs. Please tell us about the portfolio of the protein assay group that you head. My group is called the Protein Research Assays (PRA) group, and we are a part of the Life Science business unit in the Bioscience Division of  Millipore. I head the R&D efforts for the PRA group, where our focus is on establishment of a vertically integrated system that develops novel recombinant proteins, antibodies and assays (RIAs, ELISAs and Luminex-based multiplex assays) for metabolic diseases (diabetes, obesity, cardiovascular, bone/cartilage metabolism), inflammation and immunology, cell signaling, epigenetics and neuroscience. What are Millipore’s future plans or focus areas in the protein assay area? In future, we will continue to expand and introduce novel assays in the above disease/research focus areas. In addition, we have plans to develop novel assays in the oncology, toxicity and stem cell research area. Today,  we have the broadest menu of panels and analytes useful for studying metabolism, inflammation and immunology, cardiovascular and bone disorders, neuroscience, toxicity and cell signaling. We offer our customers, the flexibility of selecting any analytes of their interest within a given panel.  We also sell the Luminex instrument and data reduction software. We have an excellent technical support team, and we continue to  work closely with our customers to develop novel, cutting-edge assays/panels. Are there any new therapeutic areas you plan to enter? Yes, we plan to significantly expand our multiplex portfolio in neuroscience, cell signaling, oncology, stem cells and toxicity areas in the coming years.  Jahanara Parveen ]]> <![CDATA[Commercialization of ES/iPS cell drug screening technology]]> https://biospectrumindia.com/news/95/2135/commercialization-of-es-ips-cell-drug-screening-technology.html https://biospectrumindia.com/news/95/2135/commercialization-of-es-ips-cell-drug-screening-technology.html Wed, 07 Oct 2009 14:13:00 +0530 Commercialization of ES/iPS cell drug screening technology Human ES/iPS cells are the only cell source which can be developed into various types of human functional cells including cardiomyocyte, neuron, hepatocyte and insulin secreting beta cells. Chikafumi Yokoyama, CEO, ReproCELL, Japan Embryonic stem cell (ES cell) and induced pluripotent stem cell (iPS cell) have been attracting a lot of attention. ES/iPS cells have two key advantages as a cell source: pluripotency to develop into various types of cells and the capacity for indefinite in-vitro expansion in a normal state. The combination of these two basic characteristics unleashes enormous potential for many new applications.    The ES/iPS cell business can be divided into four fields: research reagents, drug discovery tools, personalized medicine, and regenerative medicine. The growth of the research reagent market has accelerated since the invention of human iPS cell in 2007 by Prof. Shinya Yamanaka in Kyoto University.  Some countries, including Japan, have set strict guidelines to use human ES cell because of the ethical issues related to the destruction of embryos. However, since iPS cells are derived from adult cells, the ethical issues are less contentious. Moreover, iPS holds the promise of autologous cell therapy for patients. These compelling advantages mean the number of researchers involved in iPS cell is growing quickly. The application of stem cells to drug discovery is emerging rapidly. ReproCELL offers cardiotoxicity assay services using cardiomyocytes derived from ES cells (from 2008) and iPS cells (from 2009). This is the first commercially available stem cell drug discovery services, and is the subject of this article. Human ES/iPS cell technology will bring a paradigm shift in drug discovery technology in future, because various types of functional cells derived from human ES/iPS cells can be supplied infinitely. Currently, immortalized cell lines and animal derived-primary cells are usually used in drug discovery process.  However, the former lose the characteristics of normal cells, and therefore, their ability to be usefully screened for specific functions, while the latter are difficult to supply to mass production scale and suffer large lot-to-lot variation. Human ES/iPS cells are the only cell source which can be developed into various types of human functional cells including cardiomyocyte, neuron, hepatocyte, and insulin secreting beta cells. Cell-based assays using these human differentiated cells will change the drug discovery process significantly. Personalized medicine is a future target of drug discovery technology. iPS technology has enormous potential in this area. Individual iPS cells, obtained from individual somatic cells, have the potential to be differentiated to any type of functional cells. In general, metabolizing enzyme levels vary widely in individuals, and the rates of drug metabolism also vary. If an individual’s hepatocyte can be derived from iPS cells, it could be used to test the metabolism of various commercially available drugs to define an appropriate prescription. Regenerative medicine is the most promising application in ES/iPS cell field. The clinical trial by Geron Corporation is set to be a significant breakthrough in 2009. Drug discovery technology using ES/iPS cells R&D costs in pharma companies are currently growing, consuming 15-20 percent of total revenues. The reasons for this increased cost per drug are mainly due to a higher rate of attrition of candidates drugs. As regulatory agencies raise safety standards, poor toxicity profiles are increasingly seen as a liability that has to be better managed. If the efficacy and toxicity of the drug candidate could be predicted more accurately at earlier stages of drug development, overall R&D cost and drug development period can be reduced significantly.  Human ES/iPS cells have enormous potential to impact on this issue. Drug-induced QT interval prolongation (DIQTIP) leading to serious ventricular arrhythmias poses a major safety concern for the development and use of new drug candidates. Candidate compounds in clinical development have been dropped as a result of DIQTIP and many marketed drugs have been withdrawn. This significant safety issue has caused regulatory agencies such as the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) to require pharmaceutical companies to implement safety studies to minimize the risk of QT interval prolongation. Several preclinical models are available to evaluate compound’s potential to cause DIQTIP: the most widely used are an in vitro hERG (human ether a-go-go-related gene) assay and animal-based QT prolongation assays. However, these assays are usually performed in late stages of preclinical development, due to cost and resource limitation. To predict potential QT prolongation in early drug development, we set out to establish a new assay system using cardiomyocytes derived from human ES/iPS cells. The patch-clamp based hERG assay is most widely used for this purpose and its use is regulatory mandated. However, the hERG assay can be inaccurate (false positives and false negatives) because it does not take account of non-hERG cardiac ion channels and does not measure the overall effect of a compound on cardiomyocyte function. ReproCELL has developed QTempo (QT prolongation Examination with Myocardia derived from Pluripotent cell), a significantly improved assay that incorporates spontaneously beating cardiomyocytes derived from monkey, human ES cells and human iPS cells. To validate QTempo, beating cardiomyocytes were placed on micro-electrode arrays and challenged with reference compounds known to cause clinical DIQTIP. Compounds tested included E-4031, astemizole, rofecoxib, dofetilide, flecainide, lidocaine, quinidine and terfenadine sotalol. All compounds could be assayed using QTempo at drug concentrations equal to, or lower than, those reported for the hERG assay. For example, verapamil, which does not prolong QT interval in-vivo but generates a false positive in the hERG assay, was correctly scored negative for DIQTIP in the QTempo assay.  The QTempo assay is more predictive of clinical outcome because it more closely reproduces clinical mechanisms involved in potential regulation of cardiac action: it is not limited to a single ion channel, and is built around beating cardiomyocytes. Data output for QTempo resembles the familiar ECG and is readily understood by clinicians as well as specialist scientists. Large numbers of beating cardiomyocytes derived from hiPSC can be generated for this system allowing parallel HTS screening of drugs. QTempo is a valuable tool for the more accurate prediction of clinical cardiotoxicity.Cardiotoxicty assay is the first commercialized technology for ES/iPS cell drug discovery.  ]]> <![CDATA[India's Swine Flu Bravado]]> https://biospectrumindia.com/news/95/2482/indias-swine-flu-bravado.html https://biospectrumindia.com/news/95/2482/indias-swine-flu-bravado.html Wed, 07 Oct 2009 13:28:00 +0530 India’s Swine Flu Bravado An unprepared health system is endangering the nation’s future and the tardy manner in which the country’s health authorities responded to advance warning from global experts about the impending pandemic is nothing but callousness towards the citizens Narayanan Suresh, Group Editor, BioSpectrum Once in every 40 years, the world has witnessed a pandemic influenza occurrence and the last one occurred in 1968. So when will the next one strike the world? This was the question troubling a quiet and unassuming, Dr John Boslego, director of the vaccine development program at the Program for Appropriate Technology in Health (PATH), a big but not-so-well known NGO based in Washington DC, in October 2007. He was actually worried about the spread of the bird flu or avian influenza virus (Influenza A H5N1). Quickly, he prepared a monumental report that mapped the global scenario in the case of such an outbreak happening in 2008 or 2009 which could kill up to 100 million people worldwide. He was worried more about the development of a vaccine against H5N1 and ensure that it was available in most of the developing countries. Based on his report, the World Health Organization (WHO) commissioned global consultants, McKinsey and prepared a business plan in February 2008 to build capacity to produce pandemic influenza vaccines in all corners of the world. India and the world, now ravaged by the totally unexpected strain of swine flu or Influenza A H1N1 virus should thank Dr Boslego for his foresight and wisdom. For, WHO estimated a global investment to the tune of $3 billion (Rs 15,000 crore) to set up manufacturing capacities to quickly make a vaccine against any pandemic influenza within six months of  it being declared as “pandemic” (global spread) and make available over 13 billion doses of the vaccine. More than two-thirds of the 32 companies with the capability to make quality influenza vaccines were located in Europe and the US. Past experience indicated that in the event of a global epidemic, the countries where these vaccine manufacturing units were located would lay the first claim on the products. Very little will be left for the bulk of the global population who will need it the most in an emergency situation. So WHO selected six companies —Serum Institute of India, Pune, Birmex (Mexico), Bio Farma ( Indonesia), Government Pharmaceutical Organization ( Thailand), Vabiotech ( Vietnam) and Butantan,  Brazil—to equip them with the expertise, technical assistance and production capability to develop and manufacture any new pandemic influenza vaccine. It will take approximately six months from the time seed virus samples of a new influenza strain is handed over to these companies to develop, test and commercially make available the first set of vaccine.  WHO’s  preparations have come in handy in the current situation. The seed virus of H1N1,  isolated from the first set of patients in Mexico and California were quickly sent to the newly identified companies too along with the supplies to  the vaccine makers in Europe and the US. Two other Indian companies, Panacea Biotec (Delhi) and Bharat Biotech (Hyderabad) too have got the seed virus from WHO. Animal trials of the vaccine have started in India and in Australia, China, Europe and the US small scale human trials too have begun. Most probably, the first set of vaccines will be available in December. Even if vaccines against H1N1 virus are available in India and the world, it is not necessary that Indians will get it quickly. It is here the folly or the negligence of Indian government comes in. The government did not wake up to the danger of an impending influenza epidemic in 2008 even though many health ministry officials have been making frequent visits to the WHO headquarters in Geneva. There is no strategic plan with the health ministry to tackle if the H1N1 virus infects 350 to 400 million people, as predicted by Health Minister Ghulam Nabi Azad in early August. Even a single percent mortality rate implies that 3.5 to 4 million Indians could die of the disease in the next two years. The Health Minister has talked about importing the swine flu vaccine from foreign companies. Most sensible governments abroad have already placed orders for more than 300 million doses of the vaccine from just one company, GSK. There is no word from Indian government about any vaccine orders being placed. Even the three Indian vaccine companies have so far got only oral assurances on vaccine procurement by the government. Firm buyer commitments are essential for vaccine companies because current regulations do not permit open market sale of such essential products. Till recently our government had monopolized Tamiflu, the only medicine which can treat H1N1 infection now, keeping all the national stocks with it. The Tamiflu stocks have depleted even as Indian companies are exporting these to neighbouring countries. The vaccine against H1N1 will have to stockpiled by public agencies as it will be effective only for a year. If not used within 12 months, the stocks will have to be destroyed and fresh supplies arranged for emergency use. This was the reason why most of the western governments placed advanced orders worth $ 2 billion for the pandemic influenza (H5N1) vaccine soon after the WHO report in early 2008 with the top vaccine manufacturers. So these vaccine manufacturers in Europe and USA have had a head start over their counterparts in developing nations like India. Australia has ordered  42 million doses of the H1N1 vaccine to the country’s only manufacturer, CSL Ltd, to vaccinate each of her 21 million citizens. The Beijing government has ordered 10 million doses of the vaccine from the country leading vaccine maker, Sinovac. Time is running out for our country. There are several technological challenges in increasing the quantity of the H1N1 vaccine when it is approved by the regulators for large scale use. The influenza virus grows very well in chicken eggs and alternate technologies to make it such as the cell culture method and recombinant DNA technology are untested. There are only four companies in the world which produce the special fertile eggs, called Specific Pathogen Free (SPF) eggs, which will be used to make the H1N1 vaccine. Two of these manufacturers are in the USA and the third one is in Germany. The fourth one, Venkateshwara Hatcheries, the only Asian company with the expertise to make SPF eggs, is in Pune. The capacity to produce these SPF eggs, each of which costs more than Rs 30-50 is limited. In a year, the company may be able to spare only 30 to 40 million eggs for this purpose to human vaccine makers. These eggs are used mostly in the manufacture of poultry and cattle vaccine. Each egg could be used to make just one dose of the influenza vaccine. Due to this capacity constraint within the country, it may be possible to vaccine less than 10 percent of Indians in a year. India will be lucky if other nations spare their vaccine stocks and rush to our aid if the need arises. Of course it may be too much to expect India’s health ministry officials to make strategic plans to stock pile essential vaccines in larger public interest. The ministry has been callous in neglecting the country’s future citizens, born in the last two to three years. Only 80 percent of 27 million new born children born in each of the last two years got their first shots of essential vaccines under the National Immunization Programmes. The ministry could not find more than Rs 65 crore to buy these essential vaccines from the manufacturers in the country and created a shortage. The harmful effects of not providing essential vaccination to more than 10 million children in the last two years will be evident in the next few years when infections like H1N1 spread across the country rapidly. Sitting far away from the H1N1 cities of India, Dr Boslego, had the foresight to warn the humanity against the impending danger. India’s policy makers did not listen to him for nearly two years. It is not too late even now. Instead of patting itself on the back for the limited number of deaths caused  by the swine flu virus so far, the government will do the nation a big service if it cranks up its procurement machinery and make available resources and announce its commitment to safeguard the health of its citizens immediately.  ]]> <![CDATA[Oncology market growing at 20% in APAC region]]> https://biospectrumindia.com/news/95/5891/oncology-market-growing-at-20-in-apac-region.html https://biospectrumindia.com/news/95/5891/oncology-market-growing-at-20-in-apac-region.html Wed, 07 Oct 2009 13:21:00 +0530 Oncology market growing at 20% in APAC region Like China, India too offers huge opportunities for companies to offer anti-cancer drugs because of increase in mortality rate due to cancer. In 2007, the oncology market size registered close to 70 percent growth with a market size of $54 million (Rs 259 crore). The oncology market in Asia Pacific clocked $4.5 billion (about Rs 21,593 crore) in 2008 growing close to 20 percent over 2007. According to market tracker IMS MIDAS, the market has been growing in double digit with China leading with $1.89 billion (about Rs 9,069 crore) in 2008 followed by Australia with $921 million (about Rs 4,419 crore), Korea with $613 million (about Rs 2,941 crore), Taiwan with $407 million (about Rs 1,952 crore) and Thailand with $107 million (about Rs 513 crore). Though the oncology market in Bangladesh is just over million dollars,  it has a lot of potential for drug companies as it has registered a highest growth rate in 2008 with over 70 percent against the previous year’s growth rate of 39 percent. The other fast growing markets in the region in 2008 include China with over 36 percent, India with 24 percent, Hong Kong 23 percent. Taiwan and the Philippines too offer a lot of market opportunities as these are growing at close to 20 percent in 2008. South Korea, the only country listed among the top five countries related to oncology market has posted a negative growth of six percent in 2008. While in 2007, the market in Korea witnessed a growth of over 24 percent with market size of $654 million (Rs 3,138 crore). Like China, India too offers huge opportunities for companies to offer anti-cancer drugs because of increase in mortality rate due to cancer. In 2007, the oncology market size registered close to 70 percent growth with a market size of $54 million (Rs 259 crore). Though the market witnessed a growth in 2008 in India but figures dropped to 25 percent with market size of $67 million (about Rs 321 crore). Except Bangladesh, China and Taiwan, all other countries in the region witnessed a drastic drop in the growth of the market in 2008 as compared to previous year. Malaysia witnessed a growth rate of just over eight percent in 2008 as compared to the growth rate of 53 percent registered in 2007. Similarly, the market in New Zealand recorded a growth of just five percent in 2008 as against the previous year’s growth of 25 percent. Even Indonesia witnessed same trend.  One of the key reasons for the drop in the growth rate of the market in most of the countries in the region can be attributed to global economic recession. For people living with cancer, the therapeutic treatment is beyond their reach during the current economic scenario. Barring India, in all other countries innovative drug companies such as AstraZeneca, Novartis, Roche and Sanofi-Aventis are leading the market with other players such as Schering Plough, Baxter, Johnson & Johnson, Merck, Pfizer and  Amgen. In India, companies such as Fresenius Kabi Oncology (formerly Dabur Pharma), Natco Pharma, Sun Pharma, Dr Reddy’s Labs and Panacea Biotec are leading the oncology market with each having a share of less than $10 million (about Rs 47 crore). India According to reports, the oncology market in India is about $186 million (Rs 892 crore), and is expected to reach $693 million (about Rs 3,325 crore) by 2012, growing with a Compound Annual Growth Rate (CAGR) of nearly 30 percent. Dr Reddy’s Laboratories has identified oncology as a major focus area for drug development. Shantha Biotech has targeted oncology as its primary area of interest for conducting R&D activities. Dabur Pharma is yet another company focusing on cancer research and anti-cancer products. The other companies active in oncology research include Intas Biopharmaceuticals, Glenmark, Biocon, Zenotech, Ranbaxy and Cipla. With an eye on global markets, Zydus Cadila has set up a new facility for manufacturing oncology products as well as enhancing its R&D capabilities in 2005 as it identified oncology as its long-term focus area. In November 2007, Merck has turned to Nicholas Piramal India Limited (NPIL), now called as Piramal Healthcare, for its latest research collaboration, as the preclinical offshoring trend persists. NPIL will assist Merck in creating new drugs for two of the pharma giant’s chosen oncology targets, in a deal worth up to $175 million (Rs 839 crore) per target in milestone payments, as well as royalties on any product sales. Natco Pharma, a manufacturer of branded and generic dosage products, has signed an agreement with Dr Reddy’s Laboratories for the development, manufacture and supply of a basket of value added generic oncology drugs early this April. High number of unmet needs and an ever-increasing prevalence of cancer have created a gold rush among drug companies to enter the cancer market. And every company is making efforts to launch its drug at the earliest. To meet that end, they are opting for different approaches such as partnership and tie-ups. Though launching a cancer drug successfully is a high risk proposition, but if a company is able to do it, then on the horizon are high commercial gains. Narayan Kulkarni ]]> <![CDATA[â€œDemand for biodiesel will see a steady riseâ€?]]> https://biospectrumindia.com/news/95/4016/demand-for-biodiesel-will-see-a-steady-rise.html https://biospectrumindia.com/news/95/4016/demand-for-biodiesel-will-see-a-steady-rise.html Wed, 07 Oct 2009 13:07:00 +0530 “Demand for biodiesel will see a steady rise” —CS Jadhav, director – marketing, Nandan Biomatrix, Hyderabad Hyderabad-based Nandan Biomatrix is one of the pioneering  jatropha agri-R&D companies in India with a 1,000- acre Research and Resource Center in Hyderabad. In an exclusive interview with BioSpectrum, CS Jadhav, director – marketing of Nandan Biomatrix gives a wide statistical information on the domestic and international biofuels market. What are the initiatives needed to make biofuel as an alternative to nonrenewable fuel? National mission on biodiesel has given the blending mandate of biodiesel with high speed diesel to be 20 percent by the end of 2012. To execute this mandate, the biodiesel production by the end of the year 2012 has to be 13.38 million metric tonnes. This demands 11.19 million hectares of land in the country to be converted into biofuel plantations. These numbers and statements provide scope to the players in the industry to explore the possibilities for commercializing the biofuel production. Given the facts that India spends more on the import of crude oil and has got huge potential for production of biofuels, the sector has got remarkable prospects as alternate fuel. How will the biofuel policy help to steer the growth of the biofuels sector in India? Biofuel policy gives a structured approach to all the stakeholders of the biofuel industry like farmers, government organizations and departments and corporates. This organized industrial approach leads to further growth. If the biofuel policy could address all the necessary issues like pricing and procurement of seeds, the industry shall flourish and sustain on its own. Once the policy is in place, more players shall enter the segment, leading to a competitive situation, which in turn escorts towards an established industrial segment. What are the key achievements of biofuels research in India? Eminent organizations and institutions involved in the research and development of biofuels are ICRISAT, Hyderabad; CRIDA, Hyderabad; and ICAR, New Delhi. Other than these research-focused organizations such as, TNAU, Coimbatore; TERI, New Delhi and FRI, Dehradun; are also engaged in the extensive research of biofuel crops. The key areas of research so far are for the feedstock development and for the processing of the produce into biofuel. The raw material or the feedstock development includes the crop development through varietal improvement and hybridization, and locational trials for adaptation of the species. The research on processing technology focuses on evolving cost-effective technology for the betterment of all the stake holders. The Department of Science and Technology (DST) is the committee member in producing high yield varieties for jatropha along with the coordination of the Ministry of New and Renewable Energy (MNRE) as well as the Ministry of Agriculture. Department of Biotechnology (DBT) is working on production of quality planting material of jatropha, and they have called for proposals for initiating the multi-locational trials of jatropha. Nandan Biomatrix has been selected by DBT for the project of mass multiplication of jatropha curcas saplings through vegetative cuttings since they were convinced with the R&D work taken up by us on jatropha for the past several years. DBT selected us and gave 25 percent of the work order in India. What are the business prospects of biofuels from India’s perspective? India has a huge potential for biofuels production. The favorable subtropical climate, huge stretches of culturable marginal lands and the natural resource wealth of the country stand testimonials to the fact that the country has good scope for biofuel production. India has witnessed a steep rise in energy consumption in the recent years and is today the world’s sixth largest energy consumer with the demand growing at an annual rate of 4.8 percent. The demand for diesel is estimated to grow at an annual rate of 5.8 percent till 2030. Current oil and gas reserves in India are not adequate to fulfill this growing demand. India produces about 30 percent of its annual crude oil requirement of approximately 105 million tonnes. For the balance 70 percent, the country relies on imports. The transportation sector accounts for almost 50 percent of the total crude oil consumed. This has increased the risk exposure of the country to the high price of the crude oil in the international market. Considering this demand-supply mismatch, the Government of India has undertaken two strategic measures of accelerating the exploration and production activities in the oil and gas sector; and promoting the consumption of alternate fuels. Blending mandate of 20 percent by the end of the year 2017 and the support package extended by the government in terms of tax sops and incentives are some of the eminent drivers of the industry. Other than the aforesaid factors, the country having 70 percent of its population in the rural areas, ought to focus on the production of green fuels especially for rural electrification programs. The industry is still in its nascent stage in the country and expected to take off when an organized industry status is given to the sector by bringing biofuel policy in place. Estimated Jatropha cultivation requirement [in million hectares (mn ha)] to meet biodiesel blending demand in India. How is the business potential of biofuels in the global market? Global demand for oil is rising at two percent every year. Since 1985, the energy use has increased by about 30 percent in Latin America, 40 percent in Africa and 50 percent in Asia. Over the next 20 years, the demand for energy is expected to rise by about 50-60 percent worldwide. Though Europe has started research on biodiesel in 1970s, industrial production began in the year 1992. Today the EU produces about 48.45 lakh tonnes of biodiesel of which Germany is the largest producer with 21.80 lakh tonnes per year. The US shifted its focus towards biodiesel in early 1980s, and it began its production in early 1990. The biofuels demand is expected to increase to 33 million tonnes by 2010. Where does India stand in global biofuels market? In India, the biodiesel industry is in the nascent stage. However, there has been greater awareness on biodiesel in India in the recent times due to shortage and escalating prices of petrol and diesel. With the government introducing the biofuel blending mandate, the demand for biodiesel will see a steady rise in the years to come. Indian government is very keen and if the National Biofuel Policy is approved we can be one of the most potential countries in the world. There is lot of awareness about biofuels in the country. Availability of land for biofuel crops cultivation and low cost of production have made India as one of the most potential countries for biofuel production. The scope for producing biodiesel from non-edible seeds like jatropha and pongamia is an advantage to India when compared to rest of the world.  Pradeep Kumar ]]> <![CDATA[Biofuel sector gears up for growth]]> https://biospectrumindia.com/news/95/1570/biofuel-sector-gears-up-for-growth.html https://biospectrumindia.com/news/95/1570/biofuel-sector-gears-up-for-growth.html Wed, 07 Oct 2009 12:51:00 +0530 Biofuel sector gears up for growth Understanding the need for an alternative fuel, the Government of India and the state governments have promoted the production and consumption of biodiesel since the year 2000. Proponents of biodiesel emphasize that the oilseeds are an effective alternative to nonrenewable fuels and it possesses an ability to reduce the energy dependency and greenhouse gas emission. They also highlight the opportunities it hold for greening the countryside along with providing rural employment.  Growing demand for biofuel According to an estimate in 2008, the current global biofuel usage is around 1.66 percent of total petroleum production. It is expected to increase multi-fold in the next decade. In the first generation technologies, sugar and grain crops are used as feed stocks to make bioethanol, while seed oils, fats and greases are used to make biodiesel. The second generation technology attempts to bring in different alternate processes with wider range of feed stocks including feed stock development. Biotechnology is expected to play a crucial role in developing second generation technology. It would be complemented by conventional chemical processes in making a better biofuel. Developing renewable biomaterials like jatropha brings wide-ranging benefits in social context: improve land use pattern, reduce green house gas emissions and more importantly uplift the marginal farmers with better livelihood. Budget incentives Policy initiatives by the Government of India to encourage the biofuel industry came out in the form of National Biofuels Policy in September 2008.  The policy sets an indicative target of blending 20 percent of biofuels—bioethanol and biodiesel by 2017. The policy also lay emphasis on facilitating the cultivation of non-edible oil seeds in waste and marginal lands for biodiesel production; restricting the import of free fatty acid (FFA); allowing unrestricted movement of biofuels within and outside the states; encouraging biodiesel plantations on community, government and forest waste lands; and the policy also has provisions of periodic revision for biodiesel oil seeds to provide fair price to the growers. Finance Minister of India, Pranab Mukherjee, has raised his concern over the unprecedented hike in the global prices of oil and petroleum products in 2008-09. He also asserted that the government will set up an expert committee to advice on a viable and sustainable system of pricing petroleum products. He proposed to reduce the basic customs duty on biodiesel from 7.5 percent to 2.5 percent at par with petro-diesel. “With these proposals I hope to see a smile on the faces of the green brigade!” he said. The Union budget 2009-10 proposes to fully exempt petro-diesel blended with biodiesel from excise duty. This initiative is a continuation of the National Biofuels Policy. Biofuel sector in India India is the sixth largest and one of the fastest growing energy consumers in the world. Due to limited domestic crude oil reserves, India meets about 72 percent of its crude oil and petroleum products (diesel and aviation fuel) requirement through imports, which are expected to expand further in coming years. In the last three years, India’s oil import expenditure has nearly doubled due to the escalation in global oil prices. Understanding the real potential of the biofuel sector, several companies have shifted their focus towards biofuel manufacturing—Reliance Industries, Tata Chemicals, ONGC, BPCL, HPCL, Godrej Agrovet, and Emami group are a few to name. The state governments are also not far behind. Leading by example is the state of Chattisgarh, where the Chief Minister’s car itself has been running on biodiesel. Additionally, a large number of centrally-sponsored schemes are used to promote biodiesel plantations. The budget incentives for biofuel industries put forth by the Finance Minister of India is a positive step  towards substituting biofuels partially for imported oil, boosting biofuel industries, contributing to equitable economic development, getting energy self-reliance and reducing carbon emissions. By streamlining the National Biofuels Policy in sync with the needs of the industry and farmers, India can reach the ambitious target of blending 20 percent of biofuels well before the set deadline of 2017.   Pradeep Kumar ]]> <![CDATA[Biotech firms head towards new direction]]> https://biospectrumindia.com/news/95/2335/biotech-firms-head-towards-new-direction.html https://biospectrumindia.com/news/95/2335/biotech-firms-head-towards-new-direction.html Wed, 07 Oct 2009 12:36:00 +0530 Biotech firms head towards new direction Realizing the fact that traditional approach will not yield optimal results in the market, Indian drug makers are heading towards a new direction to strengthen their business. With this series on business models, BioSpectrum will highlight those Indian biotech companies that have embarked on novel strategies to augment their growth. India, the world’s largest democracy with intense domestic competition is steadily shifting its focus from the primary sector to the secondary and tertiary sectors. Unperturbed by the international competition, the economy of the country is becoming a knowledge-based one. And giving a fillip to the life sciences sector, India is emerging as one of the five biotech leaders in the Asia Pacific region besdies Singapore, Taiwan, Japan and Korea,  During the inauguration of the golden jubilee celebrations of the National Institute of Technology Karnataka (NITK), Mangalore, Karnataka, held in August 2009, the Union minister for Law and Justice, M Veerappa Moily had said that the Union government is planning to set up nearly 50 centers of training and research in the areas of biotechnology, bioinformatics and nanotechnology. This itself is a testimony to the booming biotech industry, which is emerging as a big employer. And to achieve success in the market, Indian drug makers are enroute to a new direction. The Mumbai-based biotech company, Yashraj Biotechnology, uses human biological fluids for extracting antigens and antibodies rather than applying recombinant technologies. This method cuts down the cost of diagnostic kits. Another advantage of using this method is that the antigens derived are of the same nature as they exist in the human body. It also has its environmental benefits as the biological fluids are treated before being disposed off, which would otherwise become an environmental hazard. Similarly, NovaLead Pharma, apart from focusing on new chemical entities (NCEs) in oncology, has also adopted drug repositioning model. Under this model, it screens the existing drugs for new therapeutic uses. Although, drug repositioning model is not a new concept, it has gained momentum in the last few years, mainly due to the shrinking size of drug manufacturing in the industry, and the lack of strong R&D team. As an interesting idea, after completing the phase II trials, some biotech companies are signing licensing deals with other companies who will take the task of marketing the product. Besides minimizing the cost of production, adhering to such a concept will also give the companies, an opportunity to explore other marketing avenues. Yet another biotech company that has come up with an indigenous plan is Actis Biologics Private  Limited (ABPL). It has designed a unique business model of in-licensing promising targets. After this, values to the targets are added through the biopharma vertical product life cycle, which significantly reduces cost. But discovery of new molecules through internal research is also one of its targets. The important aspect of this model is that for each product or technology platform that the company acquires, it forms a collaboration or joint venture, and after a certain stage it spins them off as a separate entity (with ABPL holding a majority stake) even though the research is done under one umbrella company. Considering the fact that the manufacturing costs, human resources and research expenses (both preclinical and clinical) in India are cheaper as compared to other developed countries, the country has certainly made its presence felt in the biotech industry. Its prominent rise in the biotechnology sector, is attracting many global players for bilateral technical cooperation in biotechnology.   Yashraj goes from strength to strength Rather than applying recombinant technologies, Yashraj Biotechnology extracts antigens and antibodies from human biological fluids with the idea to cut down costs of diagnostic kits. Established in 1999, Yashraj Biotechnology Limited (YBL) was the brainchild of Arvind K Bhanushali, the founder director of the company and his brother Paresh B Bhanushali, the present director of R&D and production of the company. YBL deals with the business of manufacturing and supply of diagnostic antigens, mainly monoclonal to kit manufacturers and distributors. Ideally, extraction of antigens and antibodies can be done either through purification of proteins from human biological fluids or through recombinant technologies. However, YBL chose the former one not only due to its cost-effectiveness, but also because antigens extracted  through this methodology is of the same nature, which exists in the human body. These human biological fluids are of no commercial value. Dr Chander P Puri, CEO, YBL, says, “We extract these antigens and antibodies from the human biomedical waste. Usually, these biomedical fluids are disposed off by hospitals and are left unused. YBL negotiates with these hospitals to have a storage center for these biomedical waste, which is subsequently transported to our laboratories. This ultimately comes under affordable diagnostics. It is affordable because the ingredients which further go into the diagnostic kits are indigenously produced. We were always looking at methods, which could be affordable to the people.” Interestingly, this methodology also has its environmental benefits. Biological fluids when disposed as unused waste plays a major role in causing pollution. Moreover, with this methodology, the cost of protein purification comes down drastically. The only cost factor is in transporting the fluids to YBL’s manufacturing facility. YBL needs to place a proposal to the concerned hospital which is reviewed by the Clinical Ethics Committee (CEC).  It is only after the CEC approval, fluids can be collected. YBL also has to take the approval from the Central Pollution Board Control (CPBC) that reviews whether the methodology of collection is environmentally viable and in tune with the World Health Organization (WHO) guidelines. The board reviews the mode of transportation, containers and the manner in which YBL disposes off the unused matter of these fluids. Before getting involved in the collection process, the team undergoes a training program, wherein they are trained on aspects like collection methods, transport and tackling emergency situations and regulatory methods. At present, the company is focusing on diseases like tuberculosis (TB), malaria and sexually transmitted diseases like HIV/AIDS. YBL is also in the process of launching a cell-driven antigen for TB diagnosis. Monoclonal antibody is under evaluation. For HIV/AIDS, the company is coming out with an antigen extracted from human saliva. It has brought out 13 products into the market, and nine are in the R&D phase. The company is also in the business of contract manufacturing using its  own or customer supplied raw material. In this case, projects of antigens is taken up either through joint R&D venture or exclusive technology transfer for buy-back. The research team also conducts a viral safety testing for all products to be released. New business opportunities for YBL are in the areas like supply of cell-derived antigens and antibodies, monoclonal antibodies using hybridoma technology and polyclonal antibodies; cell culture facility for expression of patented clones (diagnostic and/or therapeutic), and the use of experimental animal facility for drug development.  Having achieved milestones and success in the indigenous production of antigens and antibodies, YBL is now looking at diagnostic kits manufacturing space. The company has already identified  technologies and land for the facility, and is in talks with the funding agencies. The new venture is expected to be up and running by mid-2010. Manufacturing its own diagnostic kits would in turn reduce YBL’s cost by 50 percent. YBL also intends to build a facility that spread across 150,000 sq. m., for contract manufacturing or as a JV set-up.   NovaLead looks beyond the obvious Apart from focusing on new chemical entities (NCEs) in oncology, NovaLead Pharma follows the drug repositioning model, wherein it screens existing drugs for new therapeutic uses. The genesis of NovaLead Pharma can be traced back to the inception of its parent company, VLife Sciences Technologies in 2002. VLife Sciences Technologies focused on developing screening technologies, which in turn would accelerate the whole drug discovery process. During this course, the company developed a computer-aided drug development technology that allowed them to focus on a couple of in-house research projects, some of which included new chemical entities (NCEs) in disease areas like cancer. In 2007,  the drug discovery team was demerged from VLife Sciences Technologies to form NovaLead Pharma, now based in Pune. The business model of NovaLead is to develop its discoveries up to the proof of concept in animals and then out-license or partner with either  pharmaceutical or biotechnology companies to generate revenues, which are milestone and royalty driven. Supreet Deshpande, CEO, VLife Sciences Technologies and the brainchild behind Novalead Pharma, says, “We  decided to demerge our drug discovery process to finally develop the discoveries in human trials using the screening technologies developed from the parent company, VLife Sciences Technologies. What is different in this case is the manner in which we handle the discovery process.”  Initial investment of Rs 1.5 crore, came from personal funding of  founders and angel investors. A venture capital investment was raised in April 2006, through Kotak Mahindra-Private Equity Group. The company at present pursues two in-house research programs – NCE program in oncology and new indications program in unmet needs area. Along with Deshpande, co-founder and COO, Atul Aslekar who is also a part of the VLife Sciences Group, has the responsibility to lead technology development and sourcing to continuously improve on NovaLead drug discovery process. In the avenue of technology, NovaLead has come up with virtual screening technologies like VLife Amadeus screening platform and VLife Biblica knowledge compendium (developed along with VLife Sciences).      This business model, which Despande terms as the drug repositioning model, was followed by some pharma and biotech companies in the past. Drug repositioning has been gaining importance in the last few years as an increasing number of drug development and pharmaceutical companies see their drug pipelines drying up. They have realized that several promising technologies in the past have failed to deliver as assumed. Using drug repositioning, pharmaceutical companies have achieved a number of successes. For example; Pfizers’s Viagra in erectile dysfunction and Celgene’s Thalidomide in severe erythema nodosum leprosum. NovaLead’s lead compounds in oncology, VLI27 and  Galnobax, the new indication diabetic foot ulcers, have both been filed for Patent Cooperation Treaty (PCT) and are exclusive output from VLife’s technologies. The candidate pipeline of  NovaLead Pharma has an interesting mix of new chemical entities and new indications for FDA approved drugs, majority of them qualifying for fast-track approval from the FDA. Currently, there are six  promising candidates in the pipeline, one in its human trial phase, two in their animal phase and three in the in-vitro phase. After the completion of phase I trials, NovaLead usually announces the discovery processes on the basis of the data available to attract prospective licensing partners. “We do not take the drugs to the market. Instead, after phase II, we sign licensing deals with companies who will in turn take it to the market for commercialization,” says Deshpande. A drug for diabetic foot ulcer, Galnobax, will be the first to hit the market in another two-three years as estimated by Despande. But this depends on who will ultimately take the product to the market. In the preclinical trials, Galnobax has demonstrated 42 percent improvement in curing wounds in diabetic patients. At present, clinical trials for Galnobax is partly happening in India and the US, where 40 patients have been recruited. With India positioning to become world’s diabetic capital, Despande is hopeful that the drug should hit the jackpot. “By 2011, it should be out-licensed, with the deal touching around $400-700 million (Rs 1,924-3,368 crore) mark,” he maintains. NovaLead is also looking at other therapeutic areas like age-related wrinkles, asthma and CNS-related diseases. The other  two promising targets in the pipeline include colon and pancreatic cancers.   Actis Biologics thinks out of the box Licensing promises drug candidates with more research and development, spinning out a company for each product makes Actis Biologics a cut above the rest. In 2005,  Mumbai-based Actis Biologics Private Limited (APBL) chalked out a unique business model which is yet to be emulated by its Indian counterparts. The company, an offshoot of California-based Actis Biologics, in-licenses promising targets, then adds value to the targets by accelerating the progression through the biopharmaceutical product life cycle, while reducing costs by a significant margin. At the same time, it  targets discovery of new molecules through internal research. The company acquires technologies with demonstrated applications and well-protected intellectual property. The distinguishing factor is that for each product or technology platform that it licenses or acquires, ABPL forms a joint venture or inks a collaboration, and after a certain phase spins them off as a separate company (with ABPL holding a majority stake) rather than bringing them under one  umbrella. Sanjeev Saxena, chairman and MD, Actis Biologics, says, “Actis Biologics was formed by a group of scientists, who over the years made a lot of achievements.” However, he maintains that they did not get any return of investments for their work apart from awards and acclaims. “This is the reason why we decided to form Actis Biologics. Henceforth, each of these scientists, some of them at present are on the scientific advisory board of the company (and who are equity holders as well) contribute their own technologies and research work,  they are working upon. And at the same time get their share of returns too,” adds Saxena.  “We looked at India when biotech was in its nascent stage, and we also analysed the manner in which we would pump funds. We started talking to Indian biotech companies, evaluated the cost and decided to form ABPL in 2005,” says Saxena. Over the years, the company has established academic and industry collaborations with the US. Today, the team has identified 20 disease segments. The main focus so far has been oncology and has filed 65 patents till date. Six companies which have already been registered will start the operations soon.  According to PN Venugopalan, president,  Actis Biologics, the six registered companies include Kohinoor Biotech, Aum Life Sciences, Mercury Biotech, and Deep Biotech. The Ribozyme platform division of the company would undertake development of Angiozyme, a novel platform based on nucleic acid technology. The recombinant protein platform division will develop a proprietary technology, a novel technology based on the expression level of certain cells for any protein. The gene therapy platform division is developing next generation therapies using a novel vector technology (tame virus) for delivery of a predetermined genetic sequence. The molecules will be developed and tested in human trials and partnered with larger biotechnology and pharmaceutical companies in the US, Europe and India. Once these divisions get spun out, ABPL will partner with a pharma or biotech company for marketing the product or the technology. The company has also got the Department of Biotechnology (DBT) approval for the project titled ‘Delivery of MSP36 with Lenti Viral Vector’ in 2006. The company was also in the news recently for the acquisition of its technology platform for effective treatment of  hepatic cancer from CellPoint Diagnostics, US. As far as funding is concerned, ABPL intends to raise funds of approximately $25-30 million (about Rs 120-144 crore) through private placement of equity with reputed investors. Under the name of Actis Biologics Malaysia Sdn Bhd, the company has its foothold in Malaysia. Under this, it has Telesto Diagnostics to develop coronary artery disease-based diagnostics for various abnormalities and Cogenesis to develop novel respiratory products. To tap the market, it has tied up with the Malaysian  government to come up with a biocity.  “Malaysia offered a lot of opportunities, first being the direct inflow of funds from the US and Europe. The Europeans are familiar and keen to invest in Malaysia,” says Venugopalan. ABPL plans to set up a manufacturing facility targeting South Asian market. ABPL’s much-awaited product, Angiozyme, is expected to hit the market in another two years. Angizoyme, will target mainly the lung and breast cancer market.  Anjana Pradhan and Nayantara Som ]]> <![CDATA[Kemwell eyes biologics frontiers]]> https://biospectrumindia.com/news/95/1027/kemwell-eyes-biologics-frontiers.html https://biospectrumindia.com/news/95/1027/kemwell-eyes-biologics-frontiers.html Wed, 07 Oct 2009 12:24:00 +0530 Kemwell eyes biologics frontiers Kemwell, the leading provider of contract manufacturing and development services for the top 10 pharmaceutical companies in the world and manufacturers of five of the top 10 pharmaceutical brands in India, is now making its foray into biologics. Kemwell India, the Bangalore-based contract manufacturing organization is all set to launch its aggressive growth strategies and expansion plans in the year ahead. Having consolidated its position in commercial manufacturing in India and worldwide, this 20-year-old contract manufacturer is all set to venture into biologic manufacturing. It is setting up India’s first biologic contract manufacturing facility in Bangalore with the support of Boehringer Ingelheim, Germany, world’s largest biopharmaceutical contract manufacturing company. As a part of its strategy, the company is also planning to set up shops in the US and Europe. Kemwell has made three alliances in the past one year. The most recent one is with Boehringer Ingelheim. In November 2008, Kemwell had set up a research and development (R&D) facility in Bangalore, in partnership with GlaxoSmithKline, London, for developing oral healthcare products. In April 2009,  Kemwell formed a strategic pact with the CMO Patheon (Toronto), for client referral and marketing services. The latter deal provides Kemwell with aseptic and high-potency manufacturing. It gives Patheon low-cost manufacturing for solids, semi-solids,  liquids, and related development services in India. With an employee strength of over 500 in India and 175 in Europe, and with revenues crossing Rs 300 crore, Kemwell has emerged as one of the top contract manufacturers in India. However, this success was not earned overnight. It took 26 years for the founder to turn Kemwell, initially an API manufacturering company bought from an IISc scientist with a turnover of Rs 20 lakh, and making losses of Rs 6 lakh annually, profitable. It took some time, and a lot of effort to bring the company to the present level, says Subhash Bagaria, the founder and chairman, Kemwell.  “After taking over, we started doing our own branded products, and we were making more losses. A close friend in GSK advised me to close it down since the competition was too high, and we were very small. We closed it, and then, we thought of starting contract manufacturing. Since that day, we are doing contract manufacturing and nothing else. The moment we closed API business and our own products,  the company stopped making losses,” he adds. Pure play strategy The company’s strategy has been to continuously grow itself in contract manufacturing and nothing else. Kemwell never looked at putting its own brands in the market and competing with its customers. Bagaria believes, “It is best to be a pure play player in contract manufacturing. And that is the reason why we are getting so many orders.” “As the contract manufacturing market is maturing, CMOs worldwide are becoming more competitive, striving to make a global presence, and providing expert one-stop shops. To sustain in this intensely competitive market place, we have maintained ourself as a pure play partner with high-level niche capabilities and options for collaborations and alliances,” adds Bagaria. Building long-term relationships for commercial products is necessary for any large CMO to sustain long-term growth. Kemwell has long-standing relationships with innovator companies such as AstraZeneca, Bayer, GSK, J&J, Novartis and Pfizer, for the Indian market. And to meet the enlarged pipeline of projects, Kemwell has expanded its manufacturing capacity in the last few years, and the number of its employees now is more than double. Kemwell will continue its commitment to pure-play contract manufacturing, and build on its extensive experience in manufacturing. The company sees high opportunities for supplying monoclonal antibodies in future. It is committed to provide these services in a timely and cost-effective manner. Europe focus With a long-term aim of establishing itself in Europe, the company acquired Pfizer’s manufacturing facility in Uppsala, Sweden. The facility approved by US Food and Drug Administration (FDA), the European Medicines Agency (EMEA), and Japan’s regulatory authority, supplies products to over 80 markets, including the US, Europe and Japan. The strategic acquisition resulted in significant growth in Kemwell’s contract business, and provided it the access to technology and quality standards on a continuing basis. The Swedish facility serves as the base for QP release testing into the EU, and also works hand-in-hand with the Indian facility. The addition of Pfizer’s manufacturing capabilities to its operations have allowed Kemwell to transfer some of the learning and experience, from Europe to India, and has enhanced in the expansion of its contract manufacturing business. The acquisition also provided Kemwell with a global site to serve its customer base, in addition to its four sites in Bangalore, thus significantly reducing customers’ sourcing risks. Late last year, the manufacturer’s oral solids facility in Bangalore was declared GMP-compliance for supplying to the EU. Kemwell has also completed the construction of its new oral solids facility dedicated for exports to the US, Europe and Japan.  The new plant will increase current capacity by over 10 times. Kemwell’s tablet facility has a capacity to make 500 crore tablets annually. The company currently has  manufacturing contracts for 40 crore which is about 10 percent of the capacity of the plant. Kemwell has secured contracts with a couple of European pharma majors, and has begun tech transfer from the EU. “We are in talks with few companies to utilize the remaining capacity,” informs Subhash Bagaria. Foray into biologics In a strategic move towards building its strength in the popular biologic segment, Kemwell is setting up India’s first biologic contract manufacturing facility in Bangalore. With an investment of approximately Rs 250 crore and in partnership with the German pharma giant, Boehringer Ingelheim, Kemwell is all set to manufacture biopharmaceuticals. “In biologics, there is no contract manufacturing facility in India. We are setting up the first unit with know how from Boerhinger Ingelhiem (BI), the world’s largest contract manufacturer in biologics. Biocon, Shantha, Serum and Panacea have biologic manufacturing facilities, but they are all composite companies. They do research, processes as well as manufacturing,” observes Bagaria. The facility will initially be on a small scale. It will have three lines of fermenters of 2,500 liters. In India, except Reliance Life Sciences, no other company has 2,000 liters of production capacity. The new facility will manufacture products for the US and European markets. The know-how from Boehringer Ingelheim is claimed to help Kemwell in marketing. With this collaboration, Kemwell complements its early clinical supply services ranging from full-service process development, manufacture, formulation, and fill and finish at the cGMP manufacturing facility in Bangalore. It also allows one-stop-shop through access to Boehringer Ingelheim’s cell line development with the BI Hex technology platform, followed by a preferred access to the large-scale commercial production of Boehringer Ingelheim at its facilities in Europe. “Most importantly, Kemwell and Boehringer Ingelheim will provide the customer with the state-of-the-art technology from Europe along with the benefit of low cost manufacturing from India,” says Anurag Bagaria, vice-president of Kemwell. Kemwell’s new 15,000 sq mt, facility is designed for process development, fermentation, purification and formulation of biologics for early-phase preclinical and clinical studies. The facility in construction will consist of a cGMP drug substance manufacturing facility, a sterile fill and finish facility for drug product with a floor for process development laboratories to support production of protein therapeutics from mammalian-cell culture or microbial fermentation. Kemwell has facilities dedicated for tablets, semi-solids and liquids manufacturing as well as pharmaceutical development services on the same site, and can thus synergize its current competencies by using existing trained personnel in analytical and quality services at the new facility. According to Anurag Bagaria, the Rs 300 crore company could add another Rs 250 crore from the biologic facility, when it gets ready in the next four years. The plant would be completed by the end of 2011. The search for new customers have already begun. The biologic facility will have 100-120 technical and some marketing staff. It would offer expertise in toxicology and clinical development and partner with Indian CROs (clinical research organizations), to manage these studies. Some scientists are being trained by Boehringer Ingelheim. “We believe that the future growth will be driven by the expansion of customer projects, and by our entry into new market segments like biomanufacturing of recombinant proteins and monoclonal antibodies. Increasingly, both pharmaceutical and biotechnology companies are relying on CMOs, as an integral part of their overall manufacturing strategy,” says Anurag.  Jahanara Parveen ]]> <![CDATA[Astellas forays into Indian market]]> https://biospectrumindia.com/news/95/2733/astellas-forays-into-indian-market.html https://biospectrumindia.com/news/95/2733/astellas-forays-into-indian-market.html Wed, 07 Oct 2009 11:59:00 +0530 Astellas forays into Indian market Having consolidated its position in the Japanese market, Astellas Pharma is gearing up to tap the Indian pharmaceutical market. Asurge of Japanese companies are gradually making inroads into the $8 billion (about Rs 38,535 crore) Indian pharmaceutical market, the first being Eisai Co.Ltd., in 2005, followed by the much-hyped Daiichi Sankyo-Ranbaxy deal last year. There were talks of Takeda Pharmaceuticals entering the market with a possible buyout of Torrent Pharmaceuticals, which was later known to be shelved. A recent example is the establishment of the Indian subsidiary by one of Japan's top drug maker, Astellas Pharma. Astellas, which started its operations in India (with a liaison office) back in 2007, will now have a business model of importing and marketing pharmaceuticals products. â€œAstellas Pharma India aims at establishing a business base in Indian market by developing sales and marketing activities of in-house products, especially, in immunology and urology, where Astellas has strong franchise globally,â€? says Teruo Yasufuku, managing director, Astellas Pharma India. Listed on the Tokyo Stock Exchange and the Osaka Stock Exchange, Astellas was established in Japan in April 2005, by the merger of Yamanouchi Pharmaceutical and Fujisawa Pharmaceutical. According to recent IMS report, the company incurred a global sales revenue of $5.3 billion (about Rs 25,522 crore) (MAT Dec 07) and $6.2 billion (about Rs 29,858 crore) (MAT Dec 08), while in Japan, it clocked sales of $2.2 billion (about Rs 10,594 crore) (MAT Dec 07) and $2.6 billion (about Rs 12,522 crore) (MAT Dec 08). Apart from its revenue-churning markets like the US and Europe, the company has marketing subsidiaries in seven Asian countries, which includes China, Korea, Taiwan, Hong Kong, the Philippines, Thailand and Indonesia. The establishment of its Indian subsidiary is a part of the company's overall business plan to further expand and consolidate its businesses in the Asian markets, with India and China being its top priorities. Mission India Double digit growth of the Indian pharma market proved to be a significant catalyst towards its entry into the region. â€œIndia is one country where we decided to enter by ourselves. The obvious reason was that the pharma market is growing in double digits. Within Asia, we are targeting China and India because markets like the US, Europe and Japan are stagnating in growth and price fluctuations have cost us heavy. We have promising products in our pipeline, to fulfill this purpose, a long term investment of $3.5 million (Rs 16 crore) was pumped in,â€? says Himanshu Dave, director- sales and marketing, Astellas Pharma India. â€œIndia is one of the fastest-growing pharmaceutical markets in the world. Driven by huge patient base, increasing incomes and strong penetration of health insurance, the pharma market is expected to more than double its size in the next five years,â€? adds Dave. As step one, the company intends to tap the transplantation market in India with the launch of its flagship product, Prograf. â€œIndia is the fifth largest transplant market globally. With a huge population suffering from chronic kidney failure and liver failure along with a lesser number of cadaver organ donation, we expect the government to strengthen cadaver organ donation programs,â€? says Yasufuku. â€œWe are into other areas like urology and the anti-bacterial segment, but in India, we first want to focus on the transplantation market. In India, kidney transplants constitute 90 percent of the the total transplantation market, while the remaining 10 percent is liver transplant market. According to our compiled data, we have estimated that around 4,000-4,200 kidney transplants and 400 liver transplants happen every year.â€? Other prominent companies that have already forayed into the transplantation market includes Swiss major, Novartis; Roche and Panacea Biotec. Globally, Astellas works on an in-license and out-license model apart from their own subsidiaries' business. Earlier, GlaxoSmithKline (GSK) Pharma signed a collaboration agreement with Astellas Pharma for exclusive rights for the latter's injectible anti-fungal agent, micafungin (brand name Mycamine) in the Indian market. Last year saw MNC companies setting up sales offices in India with a long term plan to make India its R&D hub. Dave claims that Astellas India has no such plans on the cards. â€œWe are only looking at sales operations in India. As of now, we understand the potentialities that the country has to offer and are in the process of understanding the market for the next five years,â€? he adds. Beyond Indian shores Globally, a major part of the Astellas' turnover comes from its mainstay products namely immunosuppresants, Progaf and Vesicare, used in overactive bladder treatment. Other products contributing to its all time growth in global sales include Harnal, Mycamin and Protopic. Other major products which the company markets include Lipitor, Micardis and Gaster. Overseas revenues contributes to 48.7 percent of its revenues with Asia contributing less than three percent. In 2008, its R&D spending was about Rs 8,431crore (JPY 159 billion) 16.5 percent of the net sales. Commenting on the Japanese market which is recently opening up, Yasufuku says, â€œThe market in Japan is tough. Most of the generic MNC companies from Europe and the US are present there in addition to over 2,000 Japanese companies. So it is a very competitive market for us.â€? Japanese market is opening up to generics, but a large portion of the population is covered by insurance, hence, cost consciousness is not a consideration there. â€œNow, around 15-20 percent of the market consists of generics and this will be economical for the government that is why Indian companies are eyeing Japanese market,â€? he adds. Looking ahead Throwing light on its future strategy in India, Yasufuku mentions that they are exploring possibilities and strategies to further expand in markets, such as, urology and anti-infective. â€œAstellas is a research-driven company, and surely will look at a robust data and patent protection system for our future research product line,â€? he claims. The company has already got the go ahead from the Drug Controller General of India (DCGI) for the launch of Prograf in India, which should be out within fiscal 2009-10. Though the company has been working with certain hospitals, however, no concrete plans are on the cards to ink any alliances with them. While many domestic and MNC pharma companies are now aggressively looking at rural markets for accelerated growth, Astellas prefers to concentrate on the urban markets. â€œTransplantation happens in the metro cities so we will be targeting only those areas unless the government starts some initiatives in the rural areas. Transplantations are promoted because that is a better way of living rather than opting for dialysis,â€? says Yasufuku. Astellas is now looking at India and China as the major markets of growth. Its marketing subsidiary in China, incurred a sales revenue of $100 million (about Rs 481crore). Its flagship product, Prograf, boasts around 50 percent share in the calcineurin inhibitor market â€œThe Chinese pharma market size is said to be $20 billion (about Rs 96,320 crore) whereas the India pharma market size is $8 billion (about Rs 38,524 crore). Both markets are promising, and we see a huge growth potentials for Astellas products in both these countries,â€? adds Yasufuku. â€œIt is quite encouraging to see a strong growing Indian economy even during the financial meltdown. The growth in the pharma sector projected for the next five years is in double digit. Insurance penetration also has been improving on a rapid pace indicating better health care environment. We are confident to start the business by this financial year,â€? concludes Yasufuku in a positive note. Nayantara Som ]]> <![CDATA[analytica Anacon India eyes life sciences sector]]> https://biospectrumindia.com/news/95/6379/analytica-anacon-india-eyes-life-sciences-sector.html https://biospectrumindia.com/news/95/6379/analytica-anacon-india-eyes-life-sciences-sector.html Wed, 23 Sep 2009 14:58:00 +0530 analytica Anacon India eyes life sciences sector —Kurt Schraudy, managing director, IMAG GmbH, Germany The fifth edition of analytica Anacon India, the international trade fair and conference covering major sectors like analytical instrumentation, biotechnology, laboratory technology and services, will feature a portfolio of exhibitors from India and abroad. The event will be held at Hitex Exhibition Center, Hyderabad, from September 29 to October 1, 2009. analytica Anacon India is part of the international exhibition network including exhibitions like analytica Munich, analytica China and analytica Vietnam. In an exclusive interview with BioSpectrum, Kurt Schraudy, managing director of IMAG GmbH, the international arm of the Messe München Group, Germany, which has over 60 years of experience in organizing international trade fairs around the world, shares more about the kind of platform offered by analytica Anacon India for the vibrant life sciences industries in India.  What is the agenda for the 5th analytica Anacon India? This year’s exhibition is certainly aiming at the life sciences sector and will have a broader showcase of the industry to achieve better synergies for all participants. The three-day event is accompanied by  conference, poster presentation and business forum. The conference is being organized by the Indian Analytical Instruments Association (IAIA) with the support of Prof. Dr Dr hc A Kettrup from the Department of Ecological Chemistry and Environment, Technical University of Munich. Topic of the conference is ‘Analytical Instrumentation: Technologies for a better quality of life’. Knowledge transfer and direct communication shall be guaranteed during the exhibition and the accompanying conference featuring talks by leading experts of the sectors. Which are the major companies or institutions that are expected to participate this year? Many new international companies like Joel, Showa Denko and TharSFC intend to use analytica Anacon India as a platform to enter the Indian market and to further their business activities. Apart from this, several international biotechnology and diagnostics companies such as Agilent, BUCHI, Bruker, Dionex, Eppendorf, GE Healthcare, INKARP, Merck, Millipore, RFCL, Shimadzu, Spinco, Thermo Fisher and Waters will participate in the event.  How will analytica Anacon India benefit the biotech and diagnostics sectors in India?  analytica Anacon India – 2009, will give exhibiting companies an international platform to present their latest developments and innovations in sectors like biotechnology, analysis, laboratory equipment, chemicals, pharmaceuticals and food industry. Our aim is to create an information platform in India for experts of the industry, R&D institutions, scientists and universities to share their ideas and learn about the state-of-the-art technologies and developments that are available for the industry. What will be the highlights of analytica Anacon India conference? analytica Anacon India 2009, provides excellent opportunities for companies to showcase the technologies and services offered by them. A scientific conference with high ranking speakers of the industry, poster presentation, business forum, social events for networking and the possibility of internet presentations are some of the highlights of the event. Has global slowdown affected the promotion of analytica Anacon India? We are very pleased to notice that the responses for this year’s analytica Anacon India and the scientific conference are very encouraging in spite of the economic crisis. We can tell that life sciences industries and research  activities are developing in India at a faster pace than ever before. In the budget announced this year, the Indian government has allotted more funds for upgrading public institutions and research centers in India. This is an encouraging sign for the analytical industry.  Pradeep Kumar ]]> <![CDATA[â€œIndian analytical instrument market worth $1 billionâ€?]]> https://biospectrumindia.com/news/95/1182/indian-analytical-instrument-market-worth-1-billion.html https://biospectrumindia.com/news/95/1182/indian-analytical-instrument-market-worth-1-billion.html Wed, 23 Sep 2009 14:55:00 +0530 “Indian analytical instrument market worth $1 billion” -Dr Ramakrishnan, president, Indian Analytical Instruments Association and vice president of the Chromatographic Society of India Indian Analytical Instruments Association (IAIA), an exclusive professional body was formed in 1996 with a vision to promote, encourage and develop the growth of analytical instruments industry. In an freewheeling interview, Dr Ramakrishnan, president of IAIA, tells us more about the focus areas of IAIA and the general scenario of analytical industry in India. How many members are there in IAIA and what kind of exposure is given to them? We have about 80 corporate members, out of which over 20 companies became members during the last six months. We hope to continue our membership drive and it will be a great day when we are able to become an association of 100 members. We ensure that the profiles of all our member companies are listed on the IAIA website, so that any customer who needs to contact any of our members will be able to do that from a single point. The members will also have a chance to do product promotions or marketing program for a nominal fee, when the website is revamped at a later stage to accommodate more activities. The website will also function as the gateway to the analytical industry in India, for foreign manufacturers, who are looking for an agent or a distributor in India for their products. Above all, the industry needed a face and a voice to bring out the common concerns to the government agencies. More thought has to be applied in this direction and an action plan is needed. What are IAIA's initiatives to promote the analytical industry in India? Bringing an international trade show such as 'Analytica' of Munich to India in the form of analytica Anacon India, is an achievement. The association has organized four events in the past, two in Mumbai, one in Bangalore and one in Hyderabad. analytica Anacon India 2009 is the fifth in the series, and is one of the best forums, in which all the analytical instruments manufacturers, both local and foreign, and their agents and distributors are interested in showcasing their latest technologies and end products. This provides the best opportunity for any prospective buyer in India to look under one roof the choices one has and to make the necessary comparisons and also to meet with the experts from the industry. This kind of trade show also gives a chance to some of the foreign trade missions to come to India and promote their brands. The association is also organizing a three-day scientific conference in conjunction with the trade show, which gives an opportunity for research students and the chemists in the industries to learn more about new instrumental techniques and applications. This is a free service that the association is giving for all the participants of the symposium, which is quite unique and never seen any where else in the world. Thus, the association is serving the scientists and chemists of the country and this will definitely help them in appreciating the technology behind the covers and also troubleshoot, when necessary, to increase the productivity and to reduce the maintenance cost. How has the analytical industry changed over the years and what are the current market trends? Foreign exchange control was one of the major barrier to getting sophisticated analytical instrumentation to India. In the 1980s, the customs duty was so high that only some of the government institutes used to get the duty exemption or exemption was given to companies if the import was against the goods that they exported and that has brought foreign currency earnings to the country. As the foreign exchange reserves increased and as the country started opening up with the new ruling governments the laws governing the import of capital equipments changed, and the duty structure also decreased especially for basic research and development in the private sector. This opened the gate for the sales of much needed analytical instrumentation in India. In the late 1990s, when India became the signatory to the General Agreement on Tariffs and Trade (GATT) agreement, the gates started opening wider and more imports of the analytical equipment to the country started happening. Indian Pharma companies started investing more and more in the R&D of generic drugs, manufacture and formulations, as many patents of various pharmaceutical products were to expire by the turn of the 21st century. India, definitely was one of the countries to catch up with the wave and many companies invested heavily into development and manufacturing. To support this investment, it was also important to build up strong clinical services, and one could see several of them coming up within a short span of time. I recall that the first wave of expansion of pharma and brisk buying of analytical instrumentation started in 1995, followed by the second major wave from the year 2000. The traditional petroleum/petrochemicals expansions were slowing down so also the agrochemicals sector. However, the infrastructure build up increased the demand for cement and steel and the analytical and automation instruments that are part of this field started expanding. As India is rich in its population and a good number of students opting for science, there have been tremendous developments all over the country in opening up of new engineering colleges and medical colleges. The growth in the pharma industry has also increased the number of pharma colleges in the country. While pharma kept growing, its affiliated branch, biotechnology, stared growing at a high speed. While the growth of market is slow now, the areas such as nanotechnology and proteomics are developing very fast in India. In fact there are many centers that are opening up now and the demand for instruments related to these areas of research will increase. Many global manufacturers are keen on establishing their direct presence in India. How will it impact the local players and the market? Indian analytical instrument market is valued at more than $1 billion and there is a healthy share for all the players. India was not an open market, so it was not easy for the foreign companies to come and establish their direct operations here. Earlier, the demand was also not that much warranting a direct operation. However, as the scenario has changed and the demand for sophisticated instruments have increased, the foreign companies have either joined hands with their local partner in a joint venture or a direct presence. Over the years, Indian customers have been asking for more and more factory-trained engineers, regulatory compliances, faster delivery of spares etc. After a certain point, it becomes very difficult for many of the local distributors to fulfill these demands, this gives an opportunity for the foreign companies to set up their direct operations in India. It is important to mention how well our local agents have played their role in establishing the foreign brands in India and serving the Indian customers. The direct presence is generally for the high-cost products, where a high investment is required for the product support. But in the medium- and low-end segments, India is making several instruments and the price/performance ratio is very good and in this segment the foreign manufacturers are not able to compete, though they have the products. The awareness of quality both at customer end and at local manufacturers has pushed the quality index. Quality concept is the one thing that will increase the visibility and market share of the local products and I am sure that we will be able to export our products to many more countries than what we are doing today. We have more local manufacturing facilities when compared to many of our neighboring countries in South East Asia. How do you foresee the growth of the analytical instruments market in India? Life sciences is perhaps the most important area of research today and a very large amount of money is being spent for its development. One of the major areas of research within this segment is proteomics and there are a large number of laboratories in India, where the government is making major investments. Huge investment is needed for establishing these labs. India has the capability to catch up with the rest of the world and we have to focus on identifying biomarkers for some of the tropical diseases or genetic diseases, that will be one of the major revolutions that can be brought about. Jahanara Parveen ]]> <![CDATA[2009 India Excellence in Healthcare Awards]]> https://biospectrumindia.com/news/95/1056/2009-india-excellence-in-healthcare-awards.html https://biospectrumindia.com/news/95/1056/2009-india-excellence-in-healthcare-awards.html Thu, 10 Sep 2009 16:32:00 +0530 ]]> <![CDATA[Drug discovery paradigm shift]]> https://biospectrumindia.com/news/95/3836/drug-discovery-paradigm-shift.html https://biospectrumindia.com/news/95/3836/drug-discovery-paradigm-shift.html Thu, 10 Sep 2009 16:30:00 +0530 Drug discovery paradigm shift Drug discovery paradigm shift A convergence between the pharma and biotech sector will gradually see both parties leveraging their strengths in drug development, commercialization, discovery and manufacturing capabilities thus delivering innovation and changing the whole landscape of M&A deals. Global  pharmaceutical companies have been swimming in troubled waters for quite some time but the good news is that they are now on the proactive mode. Big pharma’s acquisition spree started making big news since 2008. In January 2009, Pfizer acquired biotech big-wig Wyeth for $68 billion, followed by Roche ending its long drawn hostile battle with Genentech by buying the remaining 44 percent stake, thus acquiring the latter for $46.8 billion. This was followed by Merck’s announcement in March to acquire Schering Plough for $41.1 billion. Other big deals include: El Lilly’s purchase of ImClone Systems last year, Japanese giant, Takeda Pharmaceutical’s acquisition of Millennium Pharmaceuticals and Cephalon’s takeover of Australia’s Arana Therapeutics. Convergence is the trend Analysts claim that  convergence between pharma and biotech companies is not a new trend and will continue to do so. Sujay Shetty, associate director, Pharma Life Sciences Advisory, PricewaterhouseCoopers (PwC), says, “From a global perspective, these big acquisitions have been taking place for the obvious reasons like the R&D pipeline drying up, and at the same time, biotech companies are either discovering a new molecule or a drug platform which could help replenish that pipeline. Deals like the Takeda-Millennium, ImClone-El lilly, Roche-Genentech will continue as long as big pharma sees the need to augment its pipeline which is not created in-house.” Patent expirations will open the way for a fierce generic competition. “A lot of drugs are going to be off patent in future and will face fierce competition from the generic companies, thus will marginally reduce the revenue of the pharma companies.  Increasing issues on drug safety norms delaying entry of new drugs into the market due to the stringent regulations in the clinical trials are some of the other reasons for pharma and biotech companies coming together,” says Bibhuti Bhusan Kar, program manager, South Asia & Middle East, Healthcare–Pharmaceuticals & Biotechnology, Frost & Sullivan.  Hence, industry experts claim that convergence between the two will drive the wheels of the much needed innovation for the industry. It is a healthy market which will be the apt solution for big pharma’s reeling woes.  A PwC report on ‘Lifting big pharmas prospects with biologics’ , mentions that it will primarily be the biologics sector which will drive the M&A  activity with protein-based therapeutics, MAbs and vaccines being hailed as promising sectors for growth. The same report also goes on to mention that in 2008, the therapeutic monoclonal antibodies sub-sector drew increased investment of $640 million in 46 deals, up from $477 million with 41 deals in 2007. Four of the top 10 human biotech deals in 2008, were companies focusing on therapeutic MAbs. It is also estimated that the market for MAbs  is estimated to grow at a CAGR of 16.9 percent between 2006-12. Vaccines also drew in a considerable amount of investment of $494 million from 31 deals in 2008. “In many therapeutic areas like CNS, Alzheimer’s and diabetes, we have seen that further meaningful innovation is not happening. Companies have been shifting their focus now on the root cause of any disease and understand the corrective measures to be taken more at the genetic level. Hence, a convergence between biotech and pharma will result in newer ways of  finding curative therapies than the traditional synthetic ways,” opines Nair. Moreover, maintaining an almost perfect balance between innovation on one hand and cost-efficiency on the other, it becomes the center of attention for strategy teams. Shetty mentions, “Pharma is on the lookout for new pipeline drugs. They have typically addressed that and  are  going out and buying companies. Companies are now saying that by 2012, they are to lose revenues and their scientists are not coming up with anything innovative. Therefore, buying a biotech company is the best option to keep those revenues flowing in.” “As far as cost-reduction is concerned, pharma has got a huge infrastructure for R&D. Now there is a hope for them to do it more efficiently, not just in R&D but also for the ground level and fast-end clinical works,” he adds. To keep their business up and running, companies are now drawing up biological strategies which also include tapping emerging markets. The  nature of competition is such that one day a company’s revenue might be $10 billion and with patent expiry, it is zero. “This does not happen in any industry. So the challenge is always on the innovation part of it, and cost comes after that,” observes Shetty. The recent trend of convergence has  thus changed the rules and landscape for M&A deals in the life sciences industry. Sudeep Krishna, co-lead, Healthcare and Life sciences, Deloitte India, says, “The recent convergence trend has changed the rules of M&A activities, in the sense that traditionally we’ve seen that a pharma company acquires a biotech company having one or two blockbuster drugs with the deal around Rs 100-200 crore. Now, we see them acquiring big biotech companies having a whole pipeline of promising targets because big pharma has the money. The interesting aspect we’ve to look out for is the manner in which they integrate the entities especially the talent pool from both the entities.”        Impact of convergence Drug innovation: With the convergence, the industry will now see a gradual blurring of boundaries between the biotech and pharma sectors. Such a convergence will open up avenues in the drug innovation process, the most obvious reason being that biotech companies whose forte has been innovation will replenish the drying up pipeline of pharma companies. “I think that drug innovation will go through a positive transformation. Now the cure will be much more holistic,” says Nair. Genentech for example, has cutting-edge products in both biotechnology and cancer medicines – with blockbusters  Avastin, which churned a revenue of around $2 billion last year and Herceptin, an extensive portfolio of new drugs. Over the past one year,  the number of FDA approvals for biologics has seen a gradual rise. For example, in 2008, there were 20 new molecular entity (NME) and four new biologics as compared to 16 NMEs and two biologics in 2007. Says Sanjay Singh, associate director, corporate finance, KPMG,  “Biotech will aid significantly in drug discovery research especially in target identification, and lead generation and optimization activities.” Moreover, big pharma companies are cash-rich companies. Hence, investing in expensive assets such as biologics is a risk they’re willing to take, considering the returns they’ll reap at the end. “With biotech companies focusing on molecular biology and genetic engineering approaches, and with pharma companies being the lavish spender in R&D for drugs with basic chemistry  one can expect a larger success rate in terms of output from the biotech drug development rather than pharma,” says Kar.  The whole process of drug innovation is an expensive one which does require a continuous inflow of monetary funds, and convergence will be a solution to the problem.  Licensing deals:  Typically, a biotech company is always on the lookout for revenue churning options. So licensing deals are the answer to the question wherein a biotech company can expect an inflow of cash returns in the form of upfront payments, milestone payments and royalties. Opines Krishna, “Licensing deals between pharma and biotech companies have been happening for a long time and will continue to do so. In fact, I would say that it was these licensing deals which was a stepping stone for a convergence of such a kind.” “Biotech companies had to out-license their molecules because of their limited market access, and pharma companies in-licensed molecules from biotech companies which looked promising. Later pharma companies went a step further and thought why not go in for an acquisition of these entities,” he adds. An important fact to bear in mind is that big pharma’s primary capability is commercialization while biotech strength lies in discovery and manufacturing. “Big pharma has much deeper pockets. In the present global economic environment,  biotech, which has traditionally been a beneficiary of venture capital (VC) and government funding, will have challenge in keeping the fund flow. Hence, a natural consequence of this will be licensing deals which focuses on leveraging each others strength for the best outcome,” adds Nair. Outsourcing: Outsourcing projects on the other hand will either see a status quo or a gradual increase but not  drop. Opines Singh, “It’ll lead to outsourcing of high-end preclinical research to Indian companies, though it’ll be a slow and gradual process as Indian companies will need to demonstrate their skill and knowledge base in high-end preclinical research areas.” VCs will also have a pivotal role to play. The VC market has supported the growth of the outsourcing market due to the fact that there’s a significant risk involved in bringing a drug to the market.  Manufacturing:  Manufacturing is another area which will see a positive transformation  with biotech  being a catalyst in the transformation. The dynamics of biotech manufacturing is different from pharma manufacturing, hence, the former will remain as a separate unit post-integration. “A convergence will lead to a need to invest in specialized, high-end fermentation and purification units,” says Singh. At a closer look, a pharma company will reap more benefits than its biotech counterpart. “If you look at the top 10 pharma companies, they have all made biotech investments but their manufacturing capabilities are limited. Hence, a biotech manufacturing facility will be an additional and useful asset to a pharma company,”  adds Krishna. Biosimilars: With biosimilars being the buzz word, and some movement happening in the US Congress for a regulatory pathway, analysts and industry experts are hopeful that such a convergence might boost up the biosimilars space. Above all, an important fact to bear in mind is that all pharma companies have a generic strategy in hand, which will be a big boost for the biosimilar space. According to Nair, “All the big pharma companies are talking about emerging markets and all of them have a generic strategy now. With generics being the focus for pharma companies, I see a collaboration here which will immensely benefit biosimilars. That’s because biosimilars have much better margins than other generics which will attract big pharma, even while big pharma’s commercialization capabilities will give the access and reach to biosimilars.” Integrating the two entities:  A major task in hand would be integrating assets of two entities which are in all aspects poles apart from each other. Experts have unanimously opined that companies will prefer to keep assets pertaining to R&D and manufacturing independently. Ideally, when a pharma company takes over a biotech organization, they try and preserve the culture of the latter, which is more entrepreneur-driven and polished compared to a pharma organization which is more process driven. Integration will ideally be  seen in the shared services, human resources and the financial services. The Roche-Genentech integration is an apt example. “Genentech is a fiercely independent company, and even after Roche taking over,  its R&D unit has been kept independent,” says Krishna. Singh opines that integration could happen at the sales force and manpower level. “I see integration will mainly happen at the manpower level and sales force to a certain extent. Manufacturing will be a separate unit because you’ll need a different technology. Also, there could be a synergy at the development and regulatory level,” he adds.  Company strategies Pfizer, which  has now set its foot in biologics has majorly revamped its business strategies. Following the Wyeth acquisition, it will establish a unique research model designed to advance the strong scientific capabilities of both Pfizer and Wyeth, and to support the new company’s nine diverse healthcare businesses. In order to maximize new opportunities in biopharmaceutical research, Pfizer will form two distinct research organizations—the PharmaTherapeutics Research Group and  the BioTherapeutics Research Group. The PharmaTherapeutics Research Group will focus on the discovery of small molecules and related modalities and the BioTherapeutics Research Group will focus on large-molecule research, including vaccines. The new BioTherapeutics Research Group will capitalize on Wyeth’s industry-leading expertise in biologics and build on the momentum established by both Pfizer’s Biotherapeutics and Bioinnovation Center (BBC), and centers of large-molecule research and pharmaceutical science excellence in PGRD, which will be a part of the new and larger group. This new group’s mandate will be to create a broad and deep pipeline in vaccines, antibodies, proteins, peptides, nucleic acids and other novel modalities. “Creating two distinct but complementary research organizations, led by the top scientist from each company, will provide sharper focus, less bureaucracy and clearer accountability in drug discovery,” says Jeff Kindler, CEO, Pfizer, in a press release. The new Pfizer will consist of nine diverse global healthcare businesses. The convergence between the two entities is aimed to capture key therapeutic areas such as cardiovascular, oncology, women’s health, CNS and infectious disease; vaccines, biologics and small molecules; and animal health with products for companion animals, consumer health, biologics and anti-infective. Going into emerging markets like China, Latin America and the Middle East  is also on the cards. In order to preserve the ‘biotech’ work culture of the company rather than diluting it, Genentech’s research and early development will operate as an independent center. At present, Genentech’s Avastin has been approved in the US and clinical trials are in progress to investigate the efficacy of Avastin in several other tumors. The synergy target increased to one billion Swiss francs annually, and a total one-time integration costs of approximately three billion Swiss francs has been alloted. The combined company has development portfolios with 10 new molecular entities in ongoing or planned late-stage clinical development. Following the Eli Lilly-ImClone systems deal last year, their combined oncology portfolio will target a broader array of solid tumor types including lung, breast, ovarian, colorectal, head, neck, and pancreas, thus positioning Lilly to pursue treatments of multiple cancers. Partnering with ImClone will expand Eli Lilly’s biotechnology capabilities. “We think very highly of ImClone’s ground-breaking work in oncology, particularly its success with Erbitux(R), a blockbuster targeted cancer therapy, and its ability to advance promising biotech molecules in its pipeline,” says John C Lechleiter, president and CEO, Eli Lilly. This will also help them  broaden their portfolio of marketed cancer therapies and boost Lilly’s oncology pipeline with upto three promising targeted therapies in phase III in 2009. By bringing together ImClone’s and Lilly’s oncology products, pipelines and biotech capabilities, the company is taking a step forward in addressing the challenges of patent expirations. The combined entity of Merck and Schering-Plough will bring in a combined portfolio of products in key therapeutic areas which include cardiovascular, respiratory, oncology, infectious diseases, neuroscience and women’s health. Moreover, Merck will now get a footing in the emerging markets and hence devise a strategy accordingly for these markets because of the fact that Schering-Plough generates more than 70 percent of its revenues outside the US with around $2 billion in revenues coming in from these markets. The Indian vaccine sector is a growing market and post Shantha-Sanofi deal, analysts predict that there will more such deals in this space to follow suit. Challenges  Integration of assets of both the entities could be a challenge. Biotech is a different ball game and intellectually they’re different from their pharma counterparts. While biotech, which is still in developing stage, is science-driven, pharma is mainly commercialization-driven. Kar says, “The biotech market is also much more concentrated than the pharma. “The biologics are costly as compared to the pharmaceuticals. We have to really see how pharma companies are moving ahead with the higher prices of biologics to make it a drug of choice, as the convergence will find the pressure both from the government and the consumer to slow down the growth of the healthcare costs,” Kar adds. Looking ahead With such a convergence, in the near future, one would see fewer pure biotech companies. “Pharma has the money, it has the need to reinvent itself and their solution being biotech and biotech has it own challenges. So, a convergence will be natural. Currently pharma and biotech is fairly distinctive and I see that line getting blurred,” adds Nair. Singh maintains that a major trend would be companies would have a dedicated focus on biogenerics. “Another trend would be that within the fold of a pharma company there would be a separate business units which would focus on chemical as well as biopharma. The marketing strategies might differ because normally biological compounds are driven  by value and not volume and there is a different logistics chain which is used for biological compounds,” he concludes.    Mixed reactions have emerged within the industry as to whether we can expect to see similar deals this year. There was talks of Pfizer buying out Biogen but the deal did not take off because of valuations. There were talks of Amgen being acquired as well as Bristol-Myers Squibb. “Small deals will continue to happen. However, I do not expect to see any big biotechs being up for sale. This is primarily because, they have the funds and are public entities,” said a research analyst. “ There are some big deals bound to happen this year. We can look out for some,” opines another analyst from a well-renowned firm. Nayantara Som ]]> <![CDATA[â€œBiopharma market is consolidatingâ€?]]> https://biospectrumindia.com/news/95/2047/biopharma-market-is-consolidating.html https://biospectrumindia.com/news/95/2047/biopharma-market-is-consolidating.html Thu, 10 Sep 2009 14:41:00 +0530 “Biopharma market is consolidating” —Anurag Gupta, MD, GE Healthcare Lifesciences, Chennai GE Healthcare Life Sciences provides cutting-edge technology products and processes to pharma, biopharma and biotechnology companies and major academic and research institutions globally. Over the years the company has increased its focus on its life sciences business in India, driven largely by the growth in the domestic biotechnology sector. BioSpectrum Top 20 BioSuppliers Survey 2009 ranked GE Healthcare Life Sciences as seventh with the company churning out a total life sciences business revenue of Rs 120 crore in the last fiscal. Anurag Gupta, MD, GE Healthcare Lifesciences, India, tells us more about the company’s business initiatives in India and its growth strategies. Excerpts from the interview. What are the major initiatives that steered the growth of GE Healthcare Life Sciences? We were able to grow our sales in India successfully in 2008. It is a result of our crucial investments in the market and the bright prospects of biotech sector in India. The growth was through acquisition, such as Whatman, and infrastructure development as well. Throughout the year, we made significant investments to increase our commercial footprint. By staying very close to customers, we have maintained a good growth rate despite the market slowdown. Of course, the global economic situation has affected the Indian biotech industry, but we are confident that we’ll emerge stronger with the help of all the investments we have made in India in the past 18 months. What are the major steps taken to boost the biopharmaceutical offering of the company? We have established ourselves firmly as a start-to-finish bioprocess supplier for the customers in India and a strong partner in drug discovery and development. Our research portfolio includes a complete range of leading-edge protein analysis tools and consumables and our bioprocess offering includes state-of-the-art chromatography portfolio, backed by a solid footprint in after-sales service. We have also opened our Fast Trak customer education and training center at GE’s Global Research Center in Bangalore. During the last few years, we have expanded our offering significantly through acquisitions like Wave, Biacore, Whatman and MicroCal. These additions provide an extremely compelling solution to customers whether they are pure research and academic customers or industrial customers engaged in cutting-edge biotech research and manufacturing. How is the company withstanding adverse economic situation? India is a definite growth market for GE Healthcare’s Life Sciences business and we are here for a long time. Throughout this adverse economic and business environment that is prevailing for the last 18 months, we have continued to make investments in expanding commercial footprint, strengthening dealer channel, focusing on training and development, extending our service strength, technical capabilities and marketing. We believe these investments will position us uniquely in the market in India. To what extent will the new alliance with Fujifilm benefit GE Healthcare Life Sciences? Fujifilm will develop, manufacture and supply advanced biomolecular imaging systems to GE Healthcare. The products will be sold worldwide under the GE brand in the life science research and drug discovery markets. GE Healthcare’s global presence as a supplier of reagents and instruments, and our competence in biological applications within the life science market coupled with Fujifilm’s leading imaging technologies, R&D and manufacturing capabilities will provide complete system solutions for research, drug discovery and bioanalytical applications. How encouraging is the state of global biosuppliers market? For global biopharma the issues of cost, quality and access to technology are important. The market is consolidating, key drugs will soon be coming off patent, everyone is working hard to drive cost out of their businesses, but R&D departments still have to deliver results. We are seeing an increase in productivity demands, more outsourcing of routine services and an increase in regulatory scrutiny. The advantages India holds over other markets is what is generating so much interest in the BRIC countries.  India is one of the few markets which offers a very strong double digit growth in  the biotech space. Pradeep Kumar ]]> <![CDATA[What the clinical research industry needs next?]]> https://biospectrumindia.com/news/95/2597/what-the-clinical-research-industry-needs-next.html https://biospectrumindia.com/news/95/2597/what-the-clinical-research-industry-needs-next.html Thu, 10 Sep 2009 14:31:00 +0530 What the clinical research industry needs next? -Dr  Anand Bidarkar, The author is a well-known expert in clinical research in India and is a vice president with a leading clinical research organization. The views expressed are in his personal capacity. The real growth in the clinical research industry in India started with the country amending  the Patent Act in the year 2005 to include product patent in pharma and agrochemicals. The industry has grown rapidly since then. According to an estimate conducted in 2009 the industry in India is between $350–400 million. It is nowhere near the projected value of over $1 billion by 2010. Many small and mid-sized Indian Clinical Research Organizations (CROs) are now in a precarious situation because of the after effects of global recession. As a result of this, a large numbers of students who paid lakhs of rupees for fancy clinical research degrees find themselves without employment options. The CRO companies and captive units of multinational companies (MNCs) that have the business and the ability to expand find themselves constrained due to various factors. We are in the midst of a strange paradox. The fundamental factors that made India attractive to clinical research have not changed. However, more and more people opine that conducting clinical research in India has becoming increasingly challenging. That is the bad news. The good news is that the situation can be easily remedied. The following is a five-step road map for the speedy growth of the clinical research sector in India The first and urgent initiative is to exponentially increase the number of sites and investigators in India. An overwhelming majority of the investigators are in metro cities and are running multiple trials. Overload of trials at the same few centers is impacting recruitment rates and quality of deliverables. Due to competing demands on their services many of the leading investigators have hiked their fees or grant expectations to unrealistic levels. There is a huge potential business opportunity for training institutes and Site Management Organizations (SMOs). At this stage, the industry needs large SMOs with regional or even national presence with at least 200-300 centers under their belt. The clinical research industry in India lacks the strength and the financial muscle of a unified representative body like the National Association of Software and Services Companies (NASSCOM), which was instrumental in the promotion of India’s IT industry abroad. The Indian Society for Clinical Research (ISCR) is doing good work but is largely underfunded to take up high level promotional activity on behalf of the industry. An emerging concern is the number of substandard institutes mushrooming across the country, offering fancy degrees and diplomas in clinical research. The ISCR or the government can start an accreditation program for clinical research training institutes as well as work with them to design a syllabus relevant to the industry’s needs. The next important issue is the positioning of India in terms of the quality of data generated and Good Clinical Practices (GCP) compliance. As the industry in India is fairly nascent we have to invest more resources and time in adequate training including regular refresher courses. The regulatory authorities in India have been largely supportive of clinical trials. There are however multiple issues that are needed to be resolved to ensure growth of the industry in India. The approval process has to be more time bound, transparent and consultative. The last but not the least is to educate the media and the masses about the need for clinical research and the process of conducting the research. The Indian media, especially the mass media is to a large extent a victim of the ‘guinea pig syndrome’ and tends to report everything about clinical trials through this lens. Reactions to alleged problems in clinical trials in the past have resulted in sharp reactions from the political class including threats to suspend all clinical trial activity in India. The issues were however professionally investigated and were found to be compliant with the guidelines. The industry needs to invest significant time and effort in educating the masses and other stakeholders like the media and political class. This is essential to ensure that the perception of exploitation associated with clinical trials in India does not interfere with the rational conduct of clinical research in India. ]]> <![CDATA[India, preferred choice for clinical research]]> https://biospectrumindia.com/news/95/1956/india-preferred-choice-for-clinical-research.html https://biospectrumindia.com/news/95/1956/india-preferred-choice-for-clinical-research.html Thu, 10 Sep 2009 13:01:00 +0530 India, preferred choice for clinical research As global pharma companies re-visit their strategies by dovetailing speed, cost of drug development and tapping high-growth pharma markets in their business models, India is emerging as the preferred choice for clinical research services. This prognosis is held out by a FICCI-Ernst & Young (E&Y) paper on the compelling reasons for doing clinical research in India. The Indian market is growing by leaps and bounds and is gearing itself to becoming one of the fastest growing clinical research destinations with a growth rate that is two-and-a-half times the overall market growth. India participates in 7% of global phase III and 3.2% of phase II trials with industry-sponsored trials having grown at a spectacular 39% CAGR between 2004-08. The FICCI-E&Y paper notes that the number of industry-sponsored phase II-III sites in India has grown by 116% over the last 15 months and India has moved up from rank 18 to 12 across the 60 most active countries. India ranks second in Asia after Japan in its number of industry-sponsored phase II-III clinical trial study sites and accounts for nearly 20% of all Asian study sites. Dr Surinder Kher, senior vice president, Vanthys Pharmaceutical Development and chairman, Clinical Research Task Force, FICCI, said, “The drug development scenario in India has  transformed in the last 10 years. This transformation has not only brought India to the attention of the pharmaceutical world for clinical research but many big pharma and biotechs have developed the so called ‘India Strategy’ as a part of their growth strategies. This is the beginning of the road towards scientific innovation including clinical research and the vision of India  being the drug development hub. India is  probably in the best situation than ever before to achieve this vision  with the complete commitment and partnerships between the government, industry and the academia that we have been witnessing especially in the last few years. This certainly is an exciting time.” As the world’s third-largest producer of drugs by volume, with the third-largest drug research and development workforce, India is a major player in the pharmaceutical industry. The most active 25 pharmaceutical companies worldwide, based on the number of study sites registered, are also active sponsors of clinical studies in the country The number of investigators in India has also grown the fastest among Asian, Latin American and Eastern European countries with a 42% CAGR between 2002–08. India has one of the fastest subject recruitment rates globally (nearly three to five times the global average), with screen failure and drop out rates lower by nearly 40–50%, as compared to global averages. As a result, India contributes 15–30% of global enrollment in multi-centric studies where it is a participant. Data submissions from India in the recent past have been part of at least 13 successful NDA approvals. Not surprisingly, therefore, India is ranked third across all countries after the US and China in terms of its overall attractiveness as a clinical trial destination, according to a recent AT Kearney global survey. ]]> <![CDATA[Cytotron, an innovative therapy for cancer]]> https://biospectrumindia.com/news/95/2064/cytotron-an-innovative-therapy-for-cancer.html https://biospectrumindia.com/news/95/2064/cytotron-an-innovative-therapy-for-cancer.html Thu, 10 Sep 2009 12:43:00 +0530 Cytotron, an innovative therapy for cancer Cytotron, an innovative therapy for cancer After many years of research, development and speculation, Scalene Cybernetics has indigenously developed cutting-edge non-invasive cancer treatment device, Cytotron. Thus paving the way for an innovative application process for tissue regeneration and degeneration. Non-invasive cancer treatment devices are increasingly available and are being accepted by a broad range of patients world over for their unique attributes. Most of  the leading Indian medical institutions too have installed non-invasive therapy options, however, they are all developed and manufactured by bigger foreign medical devices companies. Till recently, India could hardly boast of any such biomedical breakthrough technology. But, after several years of research, development and speculation, the indigenously developed cutting-edge non-invasive cancer treatment device, Cytotron, has finally arrived. Center for Advanced Research and Development (CARD), the research wing of Scalene Cybernetics, the Bangalore-based organization engaged in research on cutting-edge medical electronic technologies, has made a noble invention for non-invasive treatment of cancer and osteoarthritis. With over two decades of research on rotational field quantum nuclear magnetic resonance (RFQMR) technology, Dr Rajah Vijay Kumar, a pioneering researcher and an opinion leader in the field of biophysics and radiobiology along with his team at Scalene Cybernetics has invented the new non-invasive treatment for cancer and osteoarthritis. He holds the worldwide patent for his amazing invention, and has licensed the technology to Scalene to manufacture and market it internationally. According to Dr Kumar, director and chief scientific officer, CARD and board chairman of Scalene Cybernetics, “The development of this technology started way back in 1987. The basic idea behind this technology is to alter the transmembrane potential (TMP), the potential or voltage difference between the cell membrane in human tissue to stimulate specific protein using TMP pathways, resulting in tissue regeneration or degeneration as required.” Cytotron vs other cancer treatments The Cytotron, a breakthrough innovation, is different from other cancer treatments such as surgery, radiotherapy and chemotherapy. Based on RFQMR technology, the treatment modality through Cytotron is highly advanced and shows phenomenal improvement in patient’s quality of life without leaving any major side-effects. In fact, combining Cytotron with chemotherapy, substantially reduces the side-effects of even powerful chemotherapeutic molecules. On the other hand, Cytotron radiosensitize the tumor for traditional radiotherapy to work better on the tumor and reduce collateral damages as the surrounding tissue will have lower radiosensitivity. “Conventional radiotherapy uses ionizing radiation at the end of high frequency spectrum and can cause collateral damage,” says Dr Kumar. However, he maintains that Cytotron uses a more benign, non-ionizing variable proton density guided resonance approach. “The cancer stem cells that sing the loudest will be attacked first, poorly differentiated cells next and finally well-differentiated ones. Normal cells don’t sing at all so they are never attacked. This approach is said to have no side-effects,” Dr Kumar explains. It’s all about results The clinical trials for Cytotron were conducted at CARD center, so far over 140 terminal cancer patients have undergone treatment through the product during clinical trials. Of these, the one-year survival rate was 52 percent while 92 percent of the patients had improved quality of life, for whatever period they lived, as assessed by accepted quality of life protocols. “The technology has a proven track record, and 52 percent of the end-stage cancer patients, who were expected to live for a month or two have survived for more than a year. The three primary aims we are looking at with this technology are to arrest cancer growth, stop its spread from organ to organ and provide better quality of life,” informs Dr Kumar. Cytotron has recently obtained the European Union (EU) certification by Underwriters Laboratories (UL) as Class IIa medical device. With the Cytotron now being recognized and accepted as one of the therapeutic modality with the grant of the EU certification, there has been a widespread interest in the technology for the treatment of cancer and osteoarthritis. While commenting on the importance of CE certification, Dr Kumar says, “The CE mark is the most mandatory requirement for placement in the European Economic Area (EEA). The CE certification, which is one of the most respected marks in the world, ensures adherence to the various consumer safety, health and environmental benchmarks of the EEA countries.” The company has received requisitions to install Cytotron from Europe, Middle East, Australia, Malaysia, Canada, New Zealand, South Africa and Mexico. Dr Kumar expects over 1,000 Cytotron machines to be installed around the globe by 2015, providing relief and better quality of life to patients. Scalene has so far sold 16 units of Cytotron in India and other markets. Cytotron 864 can treat all types of solid tumors, including widely metastatic disease in terminal patients. Though terminal systemic malignant diseases can be treated, no trials have been conducted so far to prove its efficacy in patients. There have been many claims made but it is certainly true to say that Cytotron will allow the next level of performance in cancer treatment. Cytotron was developed with the help of internal funding. Dr Kumar was unable to give us the exact figure of investments made towards developing this product. However, he shared that developing Cytotron required 100 man years of research. Being a technology-oriented company, Scalene over the period has indigenously developed many technologies in the field of medical engineering, artificial intelligence, modeling and simulation. In the area of medical engineering, it has patented two important technologies – Cytotron and  Haemoseis 256, which are advanced therapeutic and diagnostic devices. The company’s current revenue is in the range of Rs 35-40 crore with Rs 6-8 crore from its diagnostic device business. The company is currently working on a new type of drug delivery product. It is also developing a device for treating hepatopancreatic dysfunctions. Jahanara Parveen ]]> <![CDATA[â€œOur aim is to foster new business via collaborationâ€?]]> https://biospectrumindia.com/news/95/1615/our-aim-is-to-foster-new-business-via-collaboration.html https://biospectrumindia.com/news/95/1615/our-aim-is-to-foster-new-business-via-collaboration.html Thu, 10 Sep 2009 12:11:00 +0530 “Our aim is to foster new business via collaboration” —Dr Albrecht Läufer, CEO, Corvay GmbH, Germany As a part of the initiative of Germany´s Federal Ministry of Education and Research to internationally market German research competence, a group of delegates were present at the recently concluded Bangalore BIO 2009, India’s largest biotechnology business conference. On the sidelines of the three-day long event, Dr Albrecht Läufer, CEO of Corvay GmbH, a German life sciences consultancy and management services company, who also represented BioRegioN, a German state Niedersachsen’s life science initiative, at Bangalore BIO 2009. Excerpts from the interview. Would you tell us more about Corvay and the services offered by it? Corvay provides expert consultancy and management services in life sciences, to customers in Germany and other countries, with a special focus on the Middle East and Asian countries, viz; India, China, Indonesia, Japan and  Singapore. The company offers services like developing business strategies and writing business plans for start-up companies and interim management. Corvay also acts as the management office of the ‘Life Science Network Niedersachsen – BioRegioN’, on behalf of the Ministry of Economics, Labor and Transport of Germany´s state of Niedersachsen. What were your expectations from Bangalore BIO 2009? What does BioRegioN has on offer?  At Bangalore BIO 2009, our aim was to exhibit the research potential and market the life sciences sector of Niedersachsen. I was campaigning for BioRegioN that offers a platform for networking for all the partners of ‘Life Science Niedersachsen goes India’ initiative. We established very good contacts with several Indian life sciences leaders, scientists and with people interested in project management for the commercialization of their products. BioRegioN is a very strong biotechnology cluster linking 150 small and medium size enterprises, large companies, 20 universities and academic research institutions. The purpose is to foster innovation and new business through collaboration. Recently, under the umbrella of the research marketing campaign of Germany’s Federal Ministry of Science and Education, BioRegioN has presented its innovative strengths in all fields of biotechnology. In India, more attention is given to infection research, bio-IT,  plant biotechnology, bioenergy and waste management. We are coordinating talks between Indian partners and members of BioRegioN, which we expect to result in collaboration contracts. We are also organizing an Indo-German conference, BioTechnica, Europe’s largest biotech event on October 7-8, 2009, in Hannover, Germany.  As part of the conference, Indian companies will get a chance to visit biotechnology firms and institutions in Germany. What are the primary aims of the ‘Life Science Niedersachsen goes India’ initiative? The campaign seeks to establish R&D cooperations between life science institutes and companies in India in the fields of diagnostics for cancer, arteriosclerosis and infectious diseases, protein research, biological databases, knowledge tools and softwares. Furthermore, the exchange of qualified employees and scientists between India and Niedersachsen shall be encouraged with their participation in infection research programs and resources management programs. How encouraging is the regulatory environment in Asia and the Middle East? Regulatory systems are different and complex in each country. Authorities in Asia have little experience with new substances and rely very much on licenses under the US or European drug administrations. Biotechnology is gaining importance in many Asian and Middle East countries, new products will be introduced as a result and there is a need for proper regulatory attention and proper IP protection as well. What are Corvay’s business initiatives in India? Our company is active in India since several years, and I’m impressed by the growth in the biotech sector. Many experienced NRI scientists and businessmen who are returning to India are investing in the country. Also, Indian pharmaceutical and vaccine companies are venturing into biotechnology, so I see India on the right track to become a powerhouse in biotechnology. Medical need and the purchasing power in India are increasing. Indian market is very well connected with other Asian markets such as Singapore, Thailand, Malaysia, Indonesia and China. So, I feel India is certainly a good and safe place to set your shop.  Ajeesh Anand ]]> <![CDATA[â€œJ&J takes a networked approach to R&D in Asiaâ€?]]> https://biospectrumindia.com/news/95/1337/jj-takes-a-networked-approach-to-rd-in-asia.html https://biospectrumindia.com/news/95/1337/jj-takes-a-networked-approach-to-rd-in-asia.html Thu, 10 Sep 2009 12:10:00 +0530 “J&J takes a networked approach to R&D in Asia” —Paul Stoffels, company group chairman, Global Research and Development, Pharmaceuticals, Johnson & Johnson, US In a freewheeling interview with BioSpectrum India, Paul Stoffels, company group chairman, Global Research and Development, Pharmaceuticals, Johnson & Johnson, shares more about the company’s NCE facility in Mumbai, which was launched in April 2009, and also discloses the company’s business strategy for the Asia-Pacific region in general and India in particular. Excerpts from that exclusive interview. QCan you elaborate on the late-phase new chemical entity (NCE) facility in Mumbai, in terms of investments, workforce and infrastructure facilities? Johnson & Johnson’s (J&J’s) new Analytical and Pharmaceutical Development Center (APDC) in northern Mumbai is the first late-phase NCE facility in India, where we will support the final pre-production testing of future new drugs and compounds. The launch of this facility, in combination with the new Asia R&D headquarters in Shanghai, underscores J&J’s commitment to entrepreneurship and  open innovation in the Asia-Pacific region. The new facility is a major advancement in the company’s goal of achieving end-to-end drug development in Asia and the integration of the global business model for our pharmaceutical sector. The APDC center offers top quality technological capabilities within a cost-effective infrastructure and serves as an important global hub, connecting scientific experts, institutes, research partners and employees of J&J. The entire site will eventually include 150-300 technical and non-technical employees, who will collaborate with other J&J teams from R&D, commercial and operations departments on a variety of projects, including those focused on infectious diseases and finding innovative treatments for HIV, tuberculosis and multi-drug resistant bacteria. QWhy did J&J chose Shanghai as the R&D headquarters for its Asian cluster rather than India? Asia continues to be a source of new innovative products that bring significant benefits to patients both globally and regionally. Over the past four years, J&J has introduced R&D capabilities in Asia in the areas of clinical trial execution, biostatistics and data management, pharmaceutical development and discovery chemistry. The company has already built a network across China through research partnerships and collaborative efforts that connect the medical and academic communities to R&D centers. Our new Shanghai Asia R&D headquarter connects a virtual R&D organization with hubs in Beijing, Mumbai, Bangalore and other R&D operational teams, and represents the third R&D cluster in J&J’s global family, following Europe and the US. Our R&D headquarters in Shanghai and APDC facility in Mumbai create a critical mass capability in the region, allowing an end-to-end approach to drug development in the region. The Shanghai headquarter is a crucial part of J&J’s portfolio development in all strategic therapeutic areas: neuroscience, cardiovascular and metabolic disease, immunology, oncology and virology. Oncology, infectious and metabolic diseases are given importance due to the high level of unmet medical need in the region.  Going forward, J&J’s Asia R&D capabilities will be expanded under a three-pillar ‘Bridge to the Future’ strategy, which addresses immediate needs and provides strong platform for future growth. The strategy includes the introduction of new R&D capabilities through which functional teams will immediately contribute to the global development program, the development of strong R&D core teams to drive innovation and development from the region, and the continued active pursuit of ‘open innovation’ in the search for new and effective healthcare solutions to patients. QWhat is J&J’s R&D strategy in India and other Asian countries? At J&J, we are taking a networked approach to R&D in Asia because we want to fuel entrepreneurship and scientific excellence in the region. We are also matching it with our commitment to open innovation. The combination of our Mumbai facility and our R&D headquarter in Shanghai creates a critical mass capability in the region, allowing an end-to-end approach to drug development in Asia. J&J is a global company and will continue to invest globally. We are increasing the amount of research conducted in India and Asia as part of our commitment to these markets. As such, our investments and activities are for the longer term and the results from our investments are expected to contribute greatly to sustainable growth in the region during the years to come. By investing in capabilities as well as scientific relationships, working with the best minds in the region and following the best discovery practices, J&J can take an end-to-end approach in providing new medicines that ensure healthy outcomes for people worldwide. QWhat is J&J’s global R&D strategy? J&J’s global strategy is focused on advancing a fresh pharmaceutical R&D model that creates value through open innovation and a personalized focus on patient solutions. As such, J&J is taking a differentiated approach to develop medicines, combining external collaborations with our expertises in drugs and diagnostics, outstanding science and technology capabilities, and the ability to take a targeted personalized approach to patient treatments in the areas of neuroscience, internal medicine, immunology, oncology, and virology. QWhat are J&J’s biotech plans for the coming year in terms of product launches?  Last year alone, J&J filed four medicines in China and six in India. Most recently, Centocor Ortho Biotech has gained FDA approval for SIMPONI (golimumab), which is used for the treatment of moderately to severely active rheumatoid arthritis, active psoriatic arthritis and active ankylosing spondylitis. J&J will introduce the first patient-administered anti-tumor necrosis factor (TNF)-alpha therapy that offers an effective once-monthly treatment option. With continued investment in this region, the company has projected an unprecedented number of filings in India and China in the upcoming years. Between 2008-13, the company expects to file a total of 52 medicines as part of its continued commitment to patients worldwide. QWhat are the major breakthroughs which J&J will be bringing about in the market? J&J will continue to embrace open innovation and support key connections among external partners, researchers, institutes of scientific excellence and R&D centers in Asia and other emerging markets. While we continue our strategy of relying on a combination of internal and in-licensed innovative drug products and technologies, we are also pro-actively collaborating with external partners to create a network of relationships that will generate new ideas and innovative technologies that could benefit the entire world. QWill J&J increase its investments in the Indian market? J&J is committed to investing in R&D globally in order to offer innovative solutions to patients from all across the world. Additionally, the company’s investment and activities in India are for the longer term, and the results from our investments are expected to contribute greatly to sustainable growth in this region in the years to come.   Nayantara Som ]]> <![CDATA[Animal trials start for India's swine flu vaccine]]> https://biospectrumindia.com/news/95/2346/animal-trials-start-for-indias-swine-flu-vaccine.html https://biospectrumindia.com/news/95/2346/animal-trials-start-for-indias-swine-flu-vaccine.html Thu, 10 Sep 2009 11:56:00 +0530 Animal trials start for India’s swine flu vaccine Slowly and steadily India’s swine flu vaccine developing companies are making good progress even as the influenza virus infects hundreds of people every day across the country. “Serum Institute will be ready to seek permission from the regulator ( DCGI) in November to seek permission for clinical trials of its swine flu vaccine on human volunteers,” said Dr Satish D Ravetkar, senior director of Serum Institute who is handling the vaccine project. If that happens, the human trials could start in early December. Hyderabad-based Bharat Biotech International has developed the swine flu vaccine using the cell lines method. “We are now doing the characterization and quality control studies on the vaccine,” said Dr Krishna Ella, chairman of Bharat Biotech. While most companies in the world have used the traditional chicken egg method, Bharat has used cell lines methodology like Novartis and Baxter. Bharat Biotech is likely to approach the regulator for approvals to start animal trials in September to generate data for human trials after three to four months. What is worrying the vaccine makers, however, is the absence of any firm commitment from the government to buy the swine flu vaccines. So far, the government has announced its intention to order 10 millions doses of the swine flu vaccine when it is ready. “But we have not got any firm order from the government on purchase quantities or price,” said sources handling the government negotiations in both Serum Institute and Bharat Biotech.  Panacea  Biotec’s joint MD Rajesh Jain had talked about the absence of support from the government to these vaccine making initiatives with no indication of quantity requirements. This is in contrast to national governments in most developed countries making advance orders to influenza H1N1 vaccine companies in the US, Europe, China and Australia to stock up as much vaccine as possible when it is ready, pointed out an industry expert. Dr Ella indicated that if everything goes well, the swine flu vaccine will be ready for the flu season starting in the winter of 2010.  Bharat Biotech is even planning to use its animal vaccine manufacturing facility, run by its associate company, Biovet, to make the swine flu vaccine, if the nation requires it. However, even with all these preparation, the company will be aiming to manufacture  just 50 to 70 million doses of the vaccine, said Dr Ella. At Serum too, an elaborate exercise is on to determine the manufacturing capacities which could be readied for large scale production. “As the influenza strain is new, the vaccine yield will be very low during the initial stages. Further, we still don’t know what will be the standard dosage to combat the H1N1 virus,” Dr Ravetkar said. The process itself is complex and time-consuming. Dr Ravetkar indicated that the immunogenicity trials will take four-to-five weeks. The toxicity studies could be taken only after reviewing these results. The toxicity studies will take another six to seven weeks. Bangalore-based Advinus Therapeutics is understood to be conducting some of the immunogenicity trials for Serum Institute. A Pune-based laboratory, Toxicology Research Foundation is reportedly doing the toxicity studies. CSL starts pediatric trials in US CSL Biotherapies has meanwhile started clinical trials of its influenza vaccine in the US too. The US government-funded trials will happen in 24 sites in the country. It is anticipated that findings from these trials will be used to determine the most appropriate dosing schedule of the Influenza A/H1N1 2009 vaccine for use in the general population. CSL said  this clinical trial program was part of a larger, global effort by CSL Biotherapies, in partnership with government and regulatory bodies, to bring an Influenza A/H1N1 2009 vaccine to market in the US, Australia and in select regions of the southern hemisphere. “The H1N1 pandemic has had a significant toll on the health and well-being of people worldwide, which makes the development of an effective vaccine against the virus an urgent public health need,” said Dr Kawsar Talaat, principal investigator of the CSL vaccine adult trials and assistant scientist in the Johns Hopkins Bloomberg School’s Department of International Health. “Through these trials, we hope to identify the most effective dose and dosing regimen to protect the public against this highly infectious new strain of influenza virus.” “Children are often at greater risk from influenza infection and its complications than adults, so it is extremely important to understand the efficacy of an H1N1 vaccine in this very vulnerable population,” said Dr Pedro Piedra, principal investigator for the vaccine pediatric trials and professor in the department of molecular virology and microbiology, and pediatrics at Baylor College of Medicine.                             Narayanan Suresh ]]> <![CDATA[Biocon beats recession]]> https://biospectrumindia.com/news/95/2512/biocon-beats-recession.html https://biospectrumindia.com/news/95/2512/biocon-beats-recession.html Thu, 10 Sep 2009 11:35:00 +0530 Biocon beats recession Industry experts forecast a business environment recovery only in 2010. But Biocon’s first quarter results indicate a quicker upsurge. Withstanding the economic downturn, Biocon, the Indian biotechnology leader, has performed strongly in the first quarter of the current financial year. The 20th leading global biotech company surprised the market with an unexpected upsurge of 83 percent. This year, the revenue shot to a high of Rs 505 crore in Q1 from Rs 277 crore recorded last year during the same period. Fiscal year 2009 poses one of the most challenging years for Biocon, where foreign currency volatility has made it difficult to manage a sharp depreciating rupee, resulting in a large Market-to-Market (MTM) losses. But considering the last fiscal as a year of learning and reckoning, Biocon is back on the growth track ready to grow aggressively in 2009-10. Revenue analysis Biocon’s Q1 consolidated revenues stood at Rs 505 crore including the business from its German subsidiary, AxiCorp. It has been a year since the German company came on board as Biocon’s subsidiary company, and during this short time, the company has delivered a significant value of Rs 190 crore of the total revenue, which did not figure in last year’s financials.  AxiCorp is a distribution business with a radically different operating parameters; therefore, it is a top line contributor with minimal addition to bottom line. It will add to bottom line when Biocon’s insulin gets marketing authorization in Europe. The company expects this to take place over the next 18-24 months. Registration process has already started in Europe where it is conducting clinical trials, both phase I and phase III. In terms of its EBITDA performance, Biocon has grown robustly. This has increased substantially over the last one year to Rs 111 crore, and to exclude AxiCorp, it has actually delivered at over 40 percent profit after tax (PAT). It had to take a huge hit in the first quarter of last year, when Biocon hardly was able to declare a PAT of  Rs 15 crore, on account of MTM losses. In this year’s first quarter, PAT  increased to Rs 58 crore, thus registering a huge jump of 283 percent. During 2008-09, Biocon experienced sharp losses and decline in profit. However, the sudden upswing in business revenue has boosted the confidence of  the company and its shareholders. The market share of the company also increased during the period. Some of its key operational areas, like  oncology and diabetic product segment have seen an upsurge. The company is also expanding its network coverage. Last year,  it took a giant step towards consolidating its presence in Gulf Cooperation Council (GCC) markets. Its  joint venture in Abu Dhabi, NeoBiocon, launched Abraxane in the UAE market for breast cancer treatment. Commenting on the results, Dr Kiran Mazumdar Shaw, CMD, Biocon says, “Biocon’s Q1’10 performance has delivered robust growth across all segments. This, we believe, is a trend that holds good prospects for the year ahead. We are making excellent progress on the research front with several programs approaching a licensing potential. We envisage that this will deliver excellent returns on our R&D investments.” Riding high on services In the first quarter performance, the company’s services sector, namely Syngene and Clinigene have shown strong performance. Syngene contributed significantly to its first quarter’s services’ numbers. Refering to the services’ business performance Dr Shaw says, “Syngene had a particularly strong quarter demonstrating good returns on the investments made over the last two years. We expect our pre-clinical and biological services to expand our customer base and increase business revenues for future quarters.” Syngene business grew from Rs 38 crore last fiscal to Rs 58 crore in Q1 this fiscal. Similarly, Clinigene grew from Rs 6 crore to Rs 9 crore, and collectively registered a boisterous growth. Although PAT is a little muted, mainly due to the interest and depreciation components which Syngene had to carry, the company expects these investments to generate good growth and good return for Biocon. Large part of these investments were made to create a dedicated research facility for BMS (Bristol Myers Squib). BMS contract services have contributed almost close to 30 percent of  Syngene’s numbers. The company’s healthcare business too have continued to build a strong portfolio of products for diabetology, oncology, nephrology, and cardiovascular diseases. The diabetology division has grown to an impressive 12th rank in ORG rankings from a starting position of 40 in 2005.  Apart from bolstering its existing portfolio,  it also had an impressive launch of Insugen 100 and an insulin analog, Basalog, which is a bio-generic insulin Glargine. Biocon’s cardiology division has also been steadily building its legacy portfolio of statins and anti-hypertensives with an impressive range of other new launches. The oncotherapeutics division has continued to grow with BioMAb EGFR – a novel monoclonal antibody for the treatment of head and neck cancer, and has been further bolstered with the addition of Abraxane, (in-licensed from Abraxis Biosciences, theUS) and its supportive care portfolio of products like Granulocyte Colony-Stimulating Factor (GCSF) and Erythropoietin (EPO). The company’s proprietary product BioMAb-EGFR is currently being tried as first line combination therapy in late phase trials in NSCLC (in combination with carboplatin and docetaxel) and Glioma (in combination with temozolomide and radiation therapy). Recruitment for the NSCLC trial is continuing, while accrual for the Glioma trial has reached its target accrual. Other multiple clinical trials led by the global consortium of partners for the development of BioMAb-EGFR are either planned, on-going or completed. These include trials in head and neck cancers, cervical cancer, esophageal cancer, diffuse intrinsic pontine glioma, pediatric glioma, pancreatic cancer and colorectal cancer. Focus on biogenerics Biocon is aggressively focussing on novel biologics and biogenerics. And like many other big biopharma players, Biocon too is betting on the novelty of upcoming US Biosimilar Bill.  Acccording to Dr Shaw,  the Bill will open up a very lucrative opportunity for Biocon. She states, “Today, we have a very rich pipeline of biosimilars or biogeneric antibodies. And these are antibodies that are going to come off patent in the next few years. So it will give us continuous market opportunity in the short, medium and long term, which makes this whole opportunity very exciting.” She continued, “Biocon is in a very unique position to take advantage of this whole thing. We have already started that process with our insulins and glargine. These products will enter that regulatory process quite soon. Our insulin is already there,  and our glargine will soon follow. We’ll have some special advantages because we have the infrastructure in place to quickly develop biogenerics for this kind of very challenging and highly regulated markets.” Strengthening its position in biogenerics, Biocon recently signed a pact with Mylan, the global generics pharma major. Biocon executed a definitive agreement with Mylan for an exclusive collaboration on the development, manufacturing, supply, commercialization of multiple and high value generic biologic compounds for the global marketplace. The deal between the two giants have brought together highly complementary capabilities that will significantly advance their efforts to secure a leading position in the emerging generic biologics industry. In terms of novel biologics, the company is also making a good progress. For instance, its oral insulin or IN-105 program is in phase III clinical development, and patient enrollment is showing a steady  progress. The CD6 or the T1h program, which is making a good progress is expected to commence phase III trials in psoriasis soon. In terms of its R&D spend,  the company is likely to continue its investment. Apart for the ones that Biocon is developing in collaboration with Mylan, especially in the insulin segment, and novel biologics and biogenerics, the former has also entered a potential licensing and partnering phase. The sequel of developments and the first quarter results clearly show that the company has managed to recover from the MTM losses that it encountered last year. And on account of the very prudent and cautious approach, Biocon has taken to foreign exchange hedging. Despite adverse economic climate, Biocon, fueled by a string of pipeline product, remains resilent, poised  and confident for a heady growth, both in terms of revenue and profitability. Jahanara Parveen ]]> <![CDATA[Vaccines, the big deal]]> https://biospectrumindia.com/news/95/2521/vaccines-the-big-deal.html https://biospectrumindia.com/news/95/2521/vaccines-the-big-deal.html Thu, 10 Sep 2009 11:22:00 +0530 Vaccines, the big deal In a first-of-its-kind deal in the region Shantha Biotechnics got acquired by world’s largest vaccine company, Sanofi-Pasteur for $613 million (Rs 3,740 crore). This has opened the possibility of greater MNC play in the vaccines segment in the region, given that India has many such likely takeover targets. In what appears to be the beginning of a new trend, India’s pioneering vaccine company, Shantha Biotechnics got acquired by world’s largest vaccine company, Sanofi-Pasteur. The vaccines division of the Sanofi-Aventis Group, Sanofi-Pasteur, executed the deal by acquiring Mérieux Alliance’s French subsidiary ShanH, which owns a majority stake (79 percent) in Hyderabad-based Shantha Biotechnics for $613 million (Rs 3,740 crore). At a valuation of over eight-times Shantha’s sales, this is the first-of-a-kind deal in the region. However,  it is not just the size of the deal that is making the market sit up and take notice. The buzz is that more such deals are in the offing. Especially, in the India market. The big pharmas with restructuring on their agenda are eyeing the Indian market. An acquisition of this nature can quickly change the complexion of their financials and put them on a fast track growth path. In that light, Sanofi-Pasteur’s acquisition is significant. Also significant is the fact that there were many other companies who were wooing Shantha, including some top Indian vaccine players. Its founder-promoter KI Varaprasad Reddy,  never in his wildest dream thought that his company one day will be valued at over eight-times the market valuation. The deal was way beyond his expectation. Though market experts believe Shantha Biotechnics is a deserving target. The love and labor of Varaprasad Reddy’s life, Shantha Biotechnics, came into existence and shot into prominence with the altruistic agenda of launching India’s first r-DNA Hepatitis-B vaccine. The company challenged the monopoly leadership of SmithKline Beecham with its hepatitis-B vaccine Shanvac-B in 1997. Today,  Shantha’s combination vaccines are sold in many countries and bought by WHO and UNESCO. According to  Sujay Shetty, associate director, PwC, the deal will certainly lead to many a boardroom discussions. “The focus is on India and the India growth story. Besides, there’s a feeling that the MNC will play a much bigger role in the vaccine market in India. The MNCs are making up for lost time when they ignored India by acquiring domestic vaccine makers and grow relatively quickly,” says Shetty.  Another market analyst adds if such generous valuations are done then more such vaccine makers in India will be willing to sell-out. There are very good reasons for the foreign MNC-interest in vaccines, elaborates Shetty.  Firstly, there has been a stagnation in the R&D pipeline globally.  Secondly,  there’s been a rise in some new diseases. Thirdly,  most of the big diseases will become bigger in emerging markets. “So, the principle is quite simple. Prevention is better than cure. If you can treat someone cheaply with vaccines, then vaccines will score high,” he says. Market research puts the current Indian vaccine industry at $737 million (Rs 3,587 crore) and it is expected to grow at about 20-25 percent over the next few years, while globally,  the vaccine industry is valued at $20.6 billion and is growing faster than the pharma industry.  This fast-paced growth and the deepening of the healthcare industry will lead to more vaccine use in India and elsewhere. India-based companies are likely to be front runners in the segment as they are years ahead of other countries,  in vaccine technology,  at least in the region. Indian vaccines are affordable and companies have ready manufacturing units that supply globally. This is enticing enough for big vaccine or pharma companies to look at India. Cashing on India Shantha-story is an example of how foreign vaccine makers want to cash in on Indian vaccine makers. This deal has in fact improved the fortunes of some of Shantha’s domestic rivals—such as Serum Institute, Panacea Biotech, Indian Immunologicals and Bharat Biotech—who also have equally rich vaccine pipeline, research and manufacturing capabilities. According to Shantha founder, Varaprasad Reddy, the deal sends a strong signal that Indian pharma and biotech companies are well respected. “The high valuation is due to our quality conscious products at low prices. We have been focusing mainly on good quality and developing new products for affordable healthcare,” he says.  Vaccines have come to represent why India is being respected.  Most Indian companies have an exciting range of product pipeline and many are in development stages. And if the interest in vaccines worldwide is anything to go by,  then Indian companies will be the top sellers of vaccines, even in developed countries. This is why foreign companies want to look at Indian companies. For Sanofi-Pasteur, the acquisition of Shantha is a sureshot way of getting into a very lucrative business, that promises to give returns for many years. Footprint in the South In this context, the single important point is: foreign companies do not have the full expertise to penetrate the local public markets by themselves in India as domestic companies have a good reach,  some of which they gained while being in an protected era. “In order to serve these public markets with Sanofi-Pasteur products,  it is critical to have the right products and to have the ability to both quickly develop and manufacture these products at low cost with a solid and recognized local presence: infrastructure in industrial operations, R&D and commercial operations,” adds Sanofi-Pasteur spokesperson. “Shantha is a foot-print in the South  and will give Sanofi-Pasteur  the opportunity to produce and deliver vaccines that conform with international standards of high order and at affordable prices for the short, mid and long term. Sanofi- Pasteur will support Shantha’s ongoing development as a platform to address the need for high quality affordable vaccination in international markets.”  Shantha has four vaccine products in its pipeline, and intends to launch a wave of new vaccines in the years to come, so Sanofi-Pasteur could utilize Shantha’s R&D capability to enhance time-to-market of its products, for example by performing early stage clinical trials. Sanofi-Pasteur intends to operate Shantha as a separate business unit,  besides it will also maximize the synergies  while retaining the competitive advantage.  Sanjeev Jain ]]> <![CDATA[GE food not more allergenic than the counterparts]]> https://biospectrumindia.com/news/95/2326/ge-food-not-more-allergenic-than-the-counterparts.html https://biospectrumindia.com/news/95/2326/ge-food-not-more-allergenic-than-the-counterparts.html Thu, 10 Sep 2009 11:12:00 +0530 GE food not more allergenic than the counterparts Allergy is an abnormal state of hypersensitivity of our body to normally innocuous substances in food, medicine or the environment. Allergy is neither new nor universal. It is not an infection that would spread. Each one of us suffer from intolerance of, or allergic reactions to, one or the other element in our environment or certain foods or drugs. Nevertheless, there is no single substance that causes allergy to us. Allergies affect millions of people and cause several deaths globally every year.     Atmospheric pollen, dust mites, animal dander, insect stings, molds, latex, cosmetics, fragrances and several others in a day-to-day contact may cause reactions in people.  Walnuts, pecans, Brazil nuts, cashews, peanuts, soybeans, some varieties of rice and wheat, cucumbers, mushrooms, fish, shellfish, eggs, milk, mother’s milk, some vegetables and fruits, and drugs like penicillin and aspirin, may cause intolerance or even true allergy in certain individuals. There have been cases where people have developed reactions to foods they have been eating for decades. To some, this happened when they shifted to a new place of residence, which did not revert when they moved back to the old place, showing that environmental influences are not necessarily the cause of the problem. But most allergies disappear as mysteriously as they appear.   While there are no reliable data on food allergies in the developing countries. In the US, five to eight percent of the children and one to two percent of the adults are prone to true allergy from some kind of  food. Children as they grow may overcome their sensitivities to certain food items, but the sensitivities acquired in adulthood would not go easily. Therefore, such people have to avoid food they are allergic to. In a classroom comprising several children of diverse genetic backgrounds but of the same age group, one or the other would be sensitive to one or the other food item. Sensitivity to eggs, fish and nuts is common. As children share their lunch at school, it isn’t easy for parents to decide on what food they can pack without risking sensitive reactions from any of their child’s friends. The greater and unanticipated risk is from inadvertent or accidental servings of offending foods. In case of highly sensitive individuals, even 1/44,000 of a peanut kernel may pose a threat to his/her life. Nevertheless, there wasn’t any simmer of protest against marketing any of the many conventional foods, which are established as severely allergenic to certain individuals. Risk of allergy from GE crops Risk of allergy from genetically engineered (GE) crops and food is projected as a major biosafety issue, stemming from baseless allegations. A gene for the Brazil nut protein was introduced into soybean to increase the content of methionine, an essential amino acid which the human body does not synthesize. The serum from people allergic to Brazil nuts cross-reacted with extracts of transgenic soybean and not with extracts of its isogenic, which links the problem to Brazil nut proteins and not the soybean. Though no one actually developed allergy by eating the transgenic soybean which was never released for public consumption, since the transgenic is likely to affect people who are allergenic to Brazil nuts, Pioneer Hi-Bred International, the developer of the product, did not proceed with it, an example of self-regulation.   The Bt Cry 9c protein in the Aventis Starlink Bt corn controls the European corn borer.  Cry 9c protein binds to the pest’s gut at a site different from that of the Cry 1 proteins, and so would be effective even if the pest develops some resistance to Cry 1 proteins.  Cry 9c protein was found to be slightly more stable in simulated digestion than other Bt proteins, and so it was thought that it might be allergenic. The United States Department of Agriculture (USDA) cleared the Cry 9c transgenic corn for use as both food and feed, but the US Environment Protection Agency (EPA) took a precautionary measure and approved this corn only for animal feed, as animals do not generally suffer from food allergies. Bt Cry 9c protein was never demonstrated to be allergenic. The US Centers for Disease Control (CDC) tested samples of blood from 17 people claimed to have developed allergenic reactions to Starlink and found that none of the blood samples showed cross-reactivity to Cry 9c protein. The Cry 9c gene is not deployed in any commercial product now.  Since transgenic products approved as the only feed may get into the food products, as has happened with Starlink Bt Cry 9c corn that appeared in Taco Bell taco shells, no transgenic is now approved exclusively for use as feed. This shows that the regulatory regime is in fact vigilant.  Ignoring the scientific background of food allergies, and the fact that the two questioned transgenes are neither allergenic nor deployed in any product, these two cases are repeated ad nauseam to make the world believe that all GE foods are allergenic and to repeatedly demand a blanket ban on GE food. In India, the charge was made against Bt cotton, though not a food crop. Even while Bt  brinjal is still in multi-location open–field trials and not available for public consumption, it is being projected as allergenic, trashing voluminous evidence that Cry 1Ac protein is not allergenic which was also confirmed during biosafety testing on Bt  brinjal by Intox at Pune and Rallis at Bangalore. Immunological basis of allergy The term allergy is used very loosely, and most people seem to have no idea of what it actually implies. True, allergy involves the immune system. Often food allergy is not differentiated from other types of adverse non-immunological reactions to food.  Since the public fears allergy, it is being exploited to whip up fear against GE food.   Mammalian systems produce four different classes of immunoglobulin proteins (Ig), the antibodies, in response to the presence of hazardous alien proteins (called antigens) that enter the body system through food or pathogens. Vaccines contain antigens (of cholera or smallpox or other pathogens) and vaccination prepares the body into producing antibodies against specific pathogens. The antibodies bind to the antigens when encountered in the body system affording the most valuable means of our body’s defense. The IgM antibodies form first, but both the quantity and importance of the later formed IgG antibodies is far greater. IgG antibodies are the most important body defense system. They bind to the antigens neutralizing them. While IgA antibodies are specifically involved in the defense of the oral cavity, the function of IgD antibodies is not very clear. For some poorly understood reasons, our immune system also produces another class of antibodies, the IgE, in response to a few proteins, which through a complex sequence of cascading biochemical events lead to true allergic reactions, manifesting as skin rashes, intestinal inflammation, cramps and diarrhoea or respiratory disorders. This process is anaphylaxis, on record since 2641 BCE, which varies in different individuals from mild and annoying to life threatening. The active compounds, triggered by IgE involvement, such as histamine, are mostly inflammatory agents that get into the blood stream making the problem systemic when different areas of the body are affected at the same time. Some similar reactions do not involve the IgE antibodies (anaphylactoid reactions), but nonetheless cause health hazards. Some non-protein compounds, like penicillin and aspirin, may also cause severe reactions; these agents called haptens must bind to an endogenous carrier protein to cause the symptoms.   Diagnosis of allergy Identifying an allergen is a long drawn process. For each individual, list of suspected sources allergens is drawn and through a dermal prick test, the possibilities are narrowed down by eliminating those that do not cause any reaction at the test site on the skin. Identification of the offending substance and demonstrating that it is true allergy involving IgE antibodies is done through an enzyme-linked immunological assay procedure.  Treatment of allergy The best way to avoid allergy is to avoid contact with the allergen, identified based on each individual’s experience.   Repeated exposure to small quantities of an allergen over a long period of time results in higher and higher titres of IgG antibodies, which in course of time would be adequate to neutralize the allergen before it had a chance to elicit IgE antibodies. This is how we overcome allergies naturally, otherwise allergies are clinically treated (immunotherapy). This slow process has worked well in treating environment-based allergies, and its success has just been demonstrated with peanuts on children who earlier developed strong reactions on eating even small quantities.  While there is no assured treatment to cure allergies, anaphylactic reactions are treated using anti-histamine or steroid drugs. Allergenic potential of foods Protein that is degraded by the gastric enzymes before reaching the intestine is very unlikely to cause allergy. This has been the basis to investigate a protein further for its allergenic potential. Based on voluminous data on the biochemistry of over 200 known allergenic proteins, tests have been developed to identify potential food allergens. It is now understood that only certain short stretches of amino acids (the components of proteins) constitute allergenic sites. These identified sites, not the whole protein, trigger the production of IgE antibodies. A consensus document on the biosafety of Bt in crops (Organization for Economic Cooperation and Development, July 2007), records that none of the Bt proteins deployed in crops, including Cry 1Ac, Cry 1Ab, Cry 2Ab and Cry 9c, share similar amino acid sequences with known proteinaceous food allergens. So far, no allergenic reactions have been reported during extensive biosafety tests on GE crops in several countries or on consumption of foods from GE crops for more than a decade.  Transgenic crop varieties are substantially equivalent to their isogenics, except for the protein coded by the transgene. The risk of allergy needs to be considered when a GE food or drug contains new protein(s), coded by the introduced genes, but not present in the isogenic variety.  For example, the Bt protein in the Bt potato tuber is new. Now this protein is known to be safe for human consumption. Similarly, the iron carrier protein ferritin, whose gene from bean or soybean is being introduced into rice to enhance its iron content, is not allergenic.   If a gene product in the non-transgenic (isogenic) variety were an allergen, it would be so in the transgenic as well. Proteins that are normally not allergenic will not suddenly become allergens in a transgenic plant. Whether a particular protein is allergenic or not, depends more on the consuming individuals rather than on the protein itself. This makes identification of allergenic proteins quite tricky. The remote possibility that Bt crop foods might sporadically cause allergenic reactions in a few individuals, in spite of voluminous evidence to the contrary, cannot be the reason to dump the whole technology which is otherwise beneficial in a number of ways.  It is near impossible to test for all the antigens and haptens in a product for the potential of allergy. Even so,  scientists have not been complacent and every new protein in a transgenic food or feed is examined for allergenicity. In fact, among all the foods we consume, the GE foods are the most thoroughly tested for allergenicity and toxicity.   Concern for public safety is very essential, but spreading fear on political compulsions and exploiting ignorance, is scare mongering. What we need is a rational attitude with concern for the larger benefits of the larger sections of the society, and not irrational blanket bans on the entire technologies.  No one ever said that the production of any of the large number of conventional foods known to cause severe allergies in a few people should be stopped.  ]]> <![CDATA[GM Foods: Should We Go For It?]]> https://biospectrumindia.com/news/95/1112/gm-foods-should-we-go-for-it.html https://biospectrumindia.com/news/95/1112/gm-foods-should-we-go-for-it.html Thu, 03 Sep 2009 11:21:00 +0530 GM Foods: Should We Go For It? India is the second largest grower of vegetable in the world just after China with an annual production estimated at 85 million tonnes. Three percent of the nation’s land area or approximately 6.2 million hectares are used to grow these vegetables by nearly 12 million farmers. The annual turnover of the vegetable farmers is more than Rs 60,000 crore. Despite such huge production numbers, India’s share of global trade is just 1.4 percent. Just five crops—potato, tomato, onion, cabbage and cauliflower—account for 60 percent of India’s vegetable production. The potential to increase production is very high because more than 42 percent of marketable produce in these five crops is rendered waste by a variety of pests. Nearly half the input costs of a farmer of these crops goes towards buying pesticides. If India’s farmers have access to genetically modified (GM) seeds in these crops, like their counterparts in 21 other countries, they will be able to make substantial savings. BioSpectrum estimates that the savings from the use of GM seeds in these five crops every year will be at least Rs 9,000 crore after expensing for the GM seeds. The effects will be dramatic: It will enhance the income of farmers, reduce prices for consumers and increase nutrition levels, and generate surpluses for exports to meet the growing demand for food all over the world. Researchers in India’s public and private institutions are in various stages of testing GM seeds in these 10 crops. A GM brinjal variety is on the verge of regulatory approval unless it is delayed by the vehement oppositions from anti-GM groups. Should we have long-winded debates on GM foods? Seven years ago, the nation went through elaborate debates and delayed the introduction of Bt cotton by at least five years. And within two years, India’s largely illiterate but knowledgeable farmers settled the issue by voting overwhelmingly for the new technology. Over 80 percent of cotton grown in the country is the GM variety. Bt cotton is no longer a debating issue. Despite all the concerns raised against the biosafety of GM foods, there is no conclusive evidence from anywhere in the world about its side effects since its introduction 13 years ago. It is important to remember that India grows nearly 70 types of vegetables. Only seven of these with prominent ones like brinjal, cucumber, bottle gourd are native to the country. The remaining 63 vegetables were brought to India from South America and Latin America by foreign traders and rulers. Just take the case of potatoes. Its origin is traced to Peru. But today it is an integral part of Indian food. So much so, potatoes account for 25 percent of India’s vegetable production and a Rs 20,800 crore economic value accrues to farmers every year from this tuber crop. If we had debated about the entry of potatoes or tomatoes or cauliflower in the earlier centuries, India would  have been a loser. The nation has to place its trust in the integrity and competence of its biotech regulators and agricultural experts should come out of their laboratories and speak their mind on this crucial issue of GM food. The regulatory uncertainty has to be removed. Currently, the introduction of Bt brinjal is stalled due to the need to produce a socio-economic survey on this crop. For pharmaceutical products such a survey is done post commercial production. Meanwhile, India’s strange silence over the need to give all the needy citizens protection against the raging swine flu vaccine continues. While the government is planning to buy a few million doses from even foreign companies, the vaccine is simply not available in sufficient quantities. Smart governments abroad have already placed their orders with all the major manufacturers. India’s vaccine manufacturers are awaiting some firm commitment from the Indian government. Let us not wait and get into the panic mode only after the death toll reaches 500 or 1,000 in the oncoming winter flu season. Funds are not the issue. It is the mindset of the bureaucracy in the health ministry which hopes the issue will just fade away after some time as information fatigue sets in. In fact, swine flu is now off the radar of people as mainstream television news channels have turned their attention to more compelling political drama in the last week of August. India-made swine flu vaccine will not be available before next summer. And there is every indication that the virulence of the H1N1 virus may increase with the onset of winter. <sureshn@cybermedia.co.in> ]]> <![CDATA[A culmination of international experts and exhibitors]]> https://biospectrumindia.com/news/95/1105/a-culmination-of-international-experts-and-exhibitors.html https://biospectrumindia.com/news/95/1105/a-culmination-of-international-experts-and-exhibitors.html Thu, 06 Aug 2009 16:45:00 +0530 analytica Anacon India Sept 29-Oct 1, 2009 |  Hyderabad A culmination of international  experts and exhibitors The fifth edition of analytica Anacon India, the international trade fair and conference covering sectors like analytical instrumentation, biotechnology, laboratory technology and services will feature a portfolio of exhibitors from India and abroad. The event will be held at Hitex Exhibition Center, Hyderabad, on September 29-October 1, 2009. analytica Anacon India is part of the international exhibition network including exhibitions like analytica Munich, analytica China and analytica Vietnam. Other than international trade fair, the accompanying conference featuring lectures by leading experts in the sector will provide a chance for knowledge transfer and networking. The conference session will cover a broad range of topics from the fields of chromatography, biotechnology and life sciences. The scientific lectures session is organized by the Indian Analytical Instruments Association (IAIA) and Prof. Dr A Kettrup (Department of ecological chemistry and environment, Technical University of Munich). Each year the conference attracts an increasing number of international speakers and achieves greater significance in the analytical industry. Eminent speakers from all across the world will present their papers on topics like analytical instrumentations, life science/biotechnology, pharmaceuticals, food safety and environmental analysis at the analytica Anacon India conference. “As in the past, the fifth edition of analytica Anacon India will give companies an international platform where they can present the latest developments including innovations in sectors like biotechnology, analysis, chemicals, pharmaceuticals and food industry. India is gaining prominence as a favorable investment and sales destination and more and more companies are showing their interest in positioning themselves on the subcontinent,” said  Klaus Dittrich, managing director of Messe München GmbH, Germany. Presentations by poster award winners are also part of the events scheduled for analytical Anacon India. Speakers Day 1 Dr John Gebler of Waters India, India; Dr Martin Hornshaw of Thermo Fisher, US; Dr A Kettrup of the University of Munich, Germany; Dr VL Ramprasad of Spinco Biotech, India; Fredrik Sundber of GE Healthcare Lifesciences, Sweden; and Prof. Dr B Buszewski of University of Torun, Poland, are the key speakers on the first day (September 29, 2009) of analytical Anacon 2009. Day 2 Dr L Huber of Lab Compliance, US; Dr Alan Handley of LGC Promochem,UK; Dr Zhan Zhaoqi of Shimadzu Asia Pacific, Singapore; Dr F McLeod of Dionex Softron, Germany; Prasenjit Kar of Varian India, India; BR Mohan of Millipore India, India; Dr J Weiss of Dionex Corporation, Germany; Dr Jeff Zonderman of Thermo Fisher, US; Dr S Lamotte of Bischoff Analysentechnik GmbH, Germany, are some of the key speakers on day two of the conference. Day 3 Dr Ajit Srivastava of Agilent Technologies, India; Subodh Chawan of Applied Biosystems, India; Dr G Tittel of LAT Limited, Germany; Niraj Vinaik of GE Sensing, India; and Dr J Blumm of Netzsch Gerätebau GmbH, Germany, are the key speakers on the final day of the conference. ]]> <![CDATA[Rank 21 - Kakatiya University]]> https://biospectrumindia.com/news/95/2612/rank-21-kakatiya-university.html https://biospectrumindia.com/news/95/2612/rank-21-kakatiya-university.html Thu, 06 Aug 2009 16:23:00 +0530 Rank 21 - Kakatiya University Department of Biotechnology Kakatiya University was established in 1976. The Department of Science and Technology, New Delhi, has identified the departments of botany, chemistry and pharmacy under FIST, while the University Grants Commission is supporting the departments like chemistry, botany and pharmacy under its DRS and SAP.    The MSc in biotechnology course was introduced in 2000, as an interdisciplinary subject on self-finance basis. The course has been developed into a separate department in 2004. Within a short span, the department developed its own building with two classrooms, computer lab, two culture rooms, a research lab, a seminar hall and a library. In view of the fast developments in this and its allied fields, the department is providing the latest equipment to train the students so that they can turn out to be good biotechnologists. So far three batches passed out from the department.  ]]> <![CDATA[Rank 18 - University of Burdwan]]> https://biospectrumindia.com/news/95/2091/rank-18-university-of-burdwan.html https://biospectrumindia.com/news/95/2091/rank-18-university-of-burdwan.html Thu, 06 Aug 2009 16:14:00 +0530 Rank 18 - University of Burdwan Department of Biotechnology The University of Burdwan occupies an exalted place amongst the universities of West Bengal. The university has been awarded with four star status by the National Assessment and Accreditation Council (NAAC) to acknowledge its contribution to the educational development of the state. The department of biotechnology was established in the year 2003. From 2006 onwards, it got financial support from DBT. The department has six faculty members including one professor, one  lecturer and four others on a  contractual basis. The department also has a specialized laboratory for molecular biology, microbiology, tissue culture, protein chemistry, computer and bioinformatics, apart from two general labs for doing routine practicals as well as research work. A 24-hour internet facility is provided for students,research scholars and faculty members. The department has a library with approximately 600 biotechnology-related books. ]]> <![CDATA[Rank 17 - Kumaun University]]> https://biospectrumindia.com/news/95/1662/rank-17-kumaun-university.html https://biospectrumindia.com/news/95/1662/rank-17-kumaun-university.html Thu, 06 Aug 2009 16:10:00 +0530 Rank 17 - Kumaun University Department of Biotechnology The Department of Biotechnology at Kumaun University was established in 2000, through the support of the Department of Biotechnology, Government of India, has developed as an important academic center of Uttarakhand.  The activities of the department are focused on quality teaching program at MSc and PhD level including the execution of major research projects in selected areas. Present intake at MSc is 20 and the admissions are based on the all India entrance examination conducted by JNU, New Delhi. The course work is completed in three semesters and in the fourth semester, students work on their theses as a partial requirement for completion of the MSc degree. The department has also signed MOUs with most of the ICAR and CSIR institutes of the region for networking projects, use of each others lab facilities and registering their research fellows for PhD. ]]> <![CDATA[Rank 16 - Bangalore University]]> https://biospectrumindia.com/news/95/1902/rank-16-bangalore-university.html https://biospectrumindia.com/news/95/1902/rank-16-bangalore-university.html Thu, 06 Aug 2009 16:07:00 +0530 Rank 16 - Bangalore University Department of Microbiology Bangalore University was established in July 1964 as an offshoot of the University of Mysore. Soon after the establishment of the Bangalore University, as a first step in the reorganization of courses of instructions, the university introduced honours courses in the year 1965-66.  The MSc course in microbiology was introduced in Bangalore University in 1992, while the Department of Microbiology with an independent status was established in 1997. Since then, the department has steadily grown. In 1998, the department received grants from the UGC to start MSc course in biotechnology. Being the frontier field in science, the department spared no efforts to offer education and training in the field of biotechnology in the best possible way. Currently, the department is offering MSc and PhD courses in both microbiology and biotechnology and also coordinates MSc course in microbiology and biotechnology in about 64 affiliated colleges of Bangalore University. ]]> <![CDATA[Rank 14 - Jamia Millia Islamia]]> https://biospectrumindia.com/news/95/7786/rank-14-jamia-millia-islamia.html https://biospectrumindia.com/news/95/7786/rank-14-jamia-millia-islamia.html Thu, 06 Aug 2009 15:39:00 +0530 Rank 14 - Jamia Millia Islamia Rank 14 - Jamia Millia Islamia Department of Biotechnology Department of Biotechnology at Jamia Millia Islamia, was established in 2008. It offers  BSc, MSc and PhD courses in biotechnology.    Prior to this, during 2001-07, BSc and MSc in biotechnology were offered in the department of biosciences of the university. At present, its student intake capacity is 30 and 20 for MSc. and BSc, respectively. In 2009, seat to applicant ratio for BSc and MSc courses were 1:72 and 1:50 respectively,  making it the most popular courses in the university. So far, six batches of MSc and five batches of BSc who have obtained their degrees are well placed in the prestigious institutions like IIT Bombay, IIT Delhi, MAMC (University of Delhi), AIIMS, New Delhi, NICD (Indian Council of Medical Research, Ministry of Health) and in reputed industries linked to biotechnology.     More than 45 students have qualified for the UGC, CSIR, ICMR, & DBT, NET JRFs. Master’s degree in biotechnology program is so popular. In an all India survey, it was rated among top 20 biotech programs for the last two consecutive years.    The department is headed by Prof. (Dr) Arif Ali, who was also the co-coordinator of MSc in biotechnology course since its inception. Prof. Ali, who’s involved in research related to environmental biotechnology has published nearly 60 research articles in journals of international and national repute. The fully-equipped research labs of the department is funded by various government agencies such as UGC, CSIR, DBT, ICMR and DST; with around 25 PhD research fellows working on various advance research topics. The department has tied-up with several research groups in the USA, UK, Germany and Italy for research purposes. ]]> <![CDATA[Rank 13 - University of Jammu]]> https://biospectrumindia.com/news/95/5113/rank-13-university-of-jammu.html https://biospectrumindia.com/news/95/5113/rank-13-university-of-jammu.html Thu, 06 Aug 2009 15:38:00 +0530 Rank 13 - University of Jammu Rank 13 - University of Jammu Department of Biotechnology The department of biotechnology at the University of Jammu was established in December 1998 with major funding from Department of Biotechnology (DBT), Government of India. Admission to the  university that offers MSc and MTech in biotechnology is made through the national JNU entrance test. The first batch of students was admitted in August 1999. Out of the 80-odd postgraduate students produced by the department, most of them have opted for higher studies and few have joined the industry. The students have also been selected for PhD programs of reputed research institutes namely IISc, CCMB, NII and NBRC. The department has developed a well-knit course curriculum to help students to gain placements in research institutions of international repute. The department has also been selected for FIST grants by the Department of Science and Technology, Government of India. ]]> <![CDATA[Rank 12 - University of Kashmir]]> https://biospectrumindia.com/news/95/6001/rank-12-university-of-kashmir.html https://biospectrumindia.com/news/95/6001/rank-12-university-of-kashmir.html Thu, 06 Aug 2009 15:32:00 +0530 Rank 12 - University of Kashmir Rank 12 - University of Kashmir Department of Biotechnology Department of Biotechnology at the University of Kashmir, was established in 2000 with the objective of attracting talented and well-trained faculty from diverse disciplines of biology to impart quality training in biotech education and research. The institute boasts of publications in high impact journals coupled with the performance of students in national and international examinations like NET, GATE, ICMR and GRE and their placement in organizations of international repute. The department offers a comprehensive MSc in biotechnology program for 15 students every year, who come through an open competition among the students graduating in diverse areas of biology. The research program of the department bases itself on investigating most modern and relevant fields of biotechnology leading to the award of MPhil or PhD degrees. ]]> <![CDATA[Rank 11 - Cochin University of Science and Technology]]> https://biospectrumindia.com/news/95/2926/rank-11-cochin-university-of-science-and-technology.html https://biospectrumindia.com/news/95/2926/rank-11-cochin-university-of-science-and-technology.html Thu, 06 Aug 2009 15:30:00 +0530 Rank 11 - Cochin University of Science and Technology Rank 11 - Cochin University of Science and Technology Department of Biotechnology The University of Cochin was reorganized as Cochin University of Science and Technology (CUSAT) in February 1986. Research activities of the department are presently centered around areas such as microbial technology, medical biochemistry, genetic engineering, molecular neurobiology, cell biology and plant biotechnology. The research students generally get absorbed as scientists in different national and international laboratories and as lecturers in universities and colleges. A center for neurosciences was established in 2000 with the intention of bringing the industries, medical colleges, research institutions and hospitals closer to its research accomplishments. The center organizes annual workshops, meetings, lectures and awareness programs. ]]> <![CDATA[Rank 10 - MS Baroda University, Baroda]]> https://biospectrumindia.com/news/95/6038/rank-10-ms-baroda-university-baroda.html https://biospectrumindia.com/news/95/6038/rank-10-ms-baroda-university-baroda.html Thu, 06 Aug 2009 15:26:00 +0530 Rank 10 - MS Baroda University, Baroda Rank 10 - MS Baroda University, Baroda Department of Microbiology and Biotechnology An excellent training ground MS Baroda University’s biotech department  specializes in research-oriented courses in biotechnology and allied areas. With full-fledged infrastructure and experienced faculties the university provides an excellent training ground for budding researchers. Maharaja Sayajirao University of Baroda’s  department of microbiology and biotechnology was started   in 1964. In 1985-86, it started MSc (biotechnology) course in addition to the master’s course in microbiology.  The biotechnology training program was started with  NBTB (DBT) and UGC’s support. By the year 2003, the department had produced 90 PhD holders. A large number of research papers are regularly published in journals of international repute. This  department was funded by DST-FIST-I under which new equipments have been purchased and other infrastructure facilities are being strengthened. Earlier too,  it  received support from UGC-DRS, UGC-DSA and COSIST programs. The program begins with the fundamental courses in biochemistry, genetics, microbiology and molecular biology.  After the fundamental courses, students proceed to a thorough study of their selected areas of specialization. They are also given basic training in developmental biology, genetic engineering, biochemical engineering and some aspects of biophysics, biostatistics, environmental biology. A distinct feature of this department is that students are made to undertake a research project, for the duration of their entire course work as a part of the practical training.  Prof. Bharat  B Chattoo, coordinator, biotechnology program, MS Baroda University, said, “The aim is to make students work independently and  enable them to carry out independent research. Projects are assigned according to the individual interests of students and are carried out in our own labs.” Students are also required to give major seminars during their course work and submit a project proposal including the term paper.  Academic year 2008-09 saw the introduction of new courses into the department. “Last year, we started a post-MSc program and this is supported by DBT. It is a program on intellectual property rights and regulatory affairs. We take 10 students and doing it in collaboration with faculty of law who help us in the legal aspects of the course,” added Prof. Chattoo.  The local industry is also involved  in this course and MSc students are sent in doing internships in companies. “Last year, we sent students to Zydus, Intas, Torrent  and the National Innovation Foundation where they spent a little more than two months to get hands-on experience,” said Prof. Chattoo.   The broad areas of research in which the department is engaged are molecular biology and genetic engineering,  microbiology and  bioprocess engineering. Some of the ongoing research projects at the moment include NMITLI project on development of novel funficide funded by CSIR, New Delhi; microarray facility under the Center of Excellence in Agri-Biotech, funded by GSBTM, Gandhinagar; plant SUMO conjugates - its role in biotic stress funded by DST, New Delhi; and molecular analysis of disease resistance signaling funded by DBT, New Delhi. The department houses centers like the Center for Genome Research and Bioinformatics Center. The Center for Genome Research was established in 1999 with initial support from GSFC Science Foundation, Baroda, under a research project sanctioned to Prof. Chattoo. Since then,  it has created and updated the facilities and extension of the laboratory from various research projects funded by DBT, CSIR, Rockefeller Foundation and Indo-Swiss Collaboration in Biotechnology. The Bioinformatics Center was started in 1989 as a distributed information sub-center (Sub-DIC) under Biotechnology Information System network (BTISnet) of the Department of Biotechnology, Ministry of Science and  Technology, Government of India. As recognition to the training activities, the center was upgraded to a distributed information center (DIC) in 2004. The main function of the center is to provide information on topics pertaining to the relevant areas of biotechnology, especially genome analysis. The center also serves as the regional node under the ICCB-net in collaboration with the Weizmann Institute of Science, Israel. “The industry does not offer challenging projects to students” —Prof. BB Chattoo, coordinator, biotechnology program, and director, Genome Research Center, MS Baroda University What makes MS Baroda University’s department of biotechnology distinct from other institutes offering  biotech courses? The most important aspect is the hands-on training which we give to students and officially we spend about 50 percent of time on practical training but in reality spend more than that time.  Again, students have to work on their research project or dissertation throughout the course. Students are given a topic so that they  can carry out the research project at their own pace and  go into an indepth analysis of the subject.  Apart from this, they are also asked to write a project from the point of view of an investigator and hence, made to work independently. We have a continuous evaluation system wherein we have an exam every week and at the end of the year choose the two best performances. The same applies for practicals. What initiatives is the department taking to foster an industry-academia relationship?  We are taking initiatives in that area, like in our board of study, we always have a representative from the industry. Even in our course like the post M Sc diploma in genetic engineering, we have left 50 percent of the seats to be sponsored by the industry. Other than that, we do small consultancy projects in collaboration with the industry. The industry claims that biotech colleges churn out quantity and not quality students. Your comments? There has been mushrooming of biotech colleges in the country and also a major rush of  commercialization of a number of professional colleges. We have to encourage students to pursue research in basic sciences rather than go into professional courses. Mainly after BSc,  students are lost to other industries. The talent is dwindling out because of this huge growth in pharma and engineering colleges. When the DBT started, the MSc courses were only five places, now there maybe 500 colleges. Nayantara Som ]]> <![CDATA[Rank 8 - Government Science College]]> https://biospectrumindia.com/news/95/2921/rank-8-government-science-college.html https://biospectrumindia.com/news/95/2921/rank-8-government-science-college.html Thu, 06 Aug 2009 15:03:00 +0530 Rank 8 - Government Science College Rank 8 - Government Science College Department of Biotechnology Government Science College is affiliated to Bangalore University. It offers 21 courses under its BSc program and three MSc programs in biotechnology, mathematics and microbiology. There are 23 departments, which are led by the senior and experienced teachers. Government Arts and Science college, started in the 1920s and  got its independent identity in the year 1972. Government Science College has been accredited by NAAC in 2003 as being eligible for B++ grade. The faculty position is adequate as per the government norms in all the departments. The college encourages participation of the teaching staff in seminars, conferences, symposiums, orientation and refresher courses as a measure towards academic growth. Since its inception, the postgraduate departments have been performing extremely well maintaining a hundred percent results in the university examinations in addition to bagging a number of ranks. ]]> <![CDATA[Rank 15 - Tamil Nadu Agricultural University]]> https://biospectrumindia.com/news/95/1591/rank-15-tamil-nadu-agricultural-university.html https://biospectrumindia.com/news/95/1591/rank-15-tamil-nadu-agricultural-university.html Thu, 06 Aug 2009 13:50:00 +0530 Rank 15 - Tamil Nadu Agricultural University Department of Plant Molecular Biology and Biotechnology Tamil Nadu Agricultural University is one of the leading agrotechnology provider in India established on June 1, 1971, in Coimbatore, Tamil Nadu. The university offers 10 undergraduate degree programs and 29 postgraduate programs in 10 colleges. Besides, the university has 32 research stations for agrotechnology development. In the life sciences stream the university offers  BTech in biotechnology and bioinformatics, MSc in biotechnology and PhD in biotechnology. BTech in biotechnology was started in the year 2002 and has an intake capacity of 43 students; BTech in bioinformatics was started in 2006 and has an intake capacity of 31 students; MSc in biotechnology was started in 1989 with an intake capacity of 18 students; and PhD in biotechnology was started in 1991 with an intake capacity of three students. All the above courses are affiliated to  Tamil Nadu Agricultural University and recognized by the Department of Biotechnology (DBT). The university has four dedicated biotech laboratories that are furnished with modern equipments to enhance the research-based activities. Each lab has the capacity to accommodate 40 students at a time. The research centers like the Center for Plant Breeding and Genetics (CPBG), Center for Plant Molecular Biology (CPMB) that focus on agricultural microbiology, biochemistry and biotechnology researches; Center for Soil and Crop Management Studies (SCMS); and Center of Plant Protection Studies (CPPS) that are located within the university campus provides a wealth of knowledge to the budding researchers and aspiring biotech students. The university has allotted 35 computers with broadband internet facilities for biotech students. Faculties of the university have experience and expertise in their own field and had published several research papers in both national and international journals. ]]> <![CDATA[Rank 6 - Guru Gobind Singh Indraprastha University]]> https://biospectrumindia.com/news/95/5682/rank-6-guru-gobind-singh-indraprastha-university.html https://biospectrumindia.com/news/95/5682/rank-6-guru-gobind-singh-indraprastha-university.html Thu, 06 Aug 2009 13:06:00 +0530 Rank 6 - Guru Gobind Singh Indraprastha University, New Delhi University School of Biotechnology Research-driven curriculum rules GGSIPU  is not only  imparting the best education at the undergraduate level which is evident by the achievements of its students but the university also promotes research-driven academic atmosphere. Guru Gobind Singh Indraprastha University (GGSIPU) was established in 1998 and is recognized by the University Grants Commission (UGC) under section 12B of UGC Act. In March 2007, it received A-Grade accreditation from National Assessment and Accreditation Council (NAAC). The University School of Biotechnology (USBT) is situated in the sprawling university campus at Kashmere Gate, Delhi, and spreads over 16 acres. Founded in 1999, USBT began with a five-and-a-half year integrated BTech/ MTech course in biotechnology with 11 semesters and PhD program. From 2004-05, the MTech program was delinked from BTech program and both are now offered under dual degree program. This has seen an increase in the number of students applying for the program.  Admission to the  programs is done strictly on the basis of merit adjudged through an all India common entrance test. The ratio of students applying and those taken was 130:1 for the year 2007-08. The school also has a research program leading to a PhD degree in biotechnology. Eleven students are pursuing research in the school under the guidance of the faculty members. The school boasts of faculty members with expertise in diverse areas of modern biology and biotechnology including molecular biology, agricultural biotechnology, biomedical research, pharmaceutical biotechnology, environmental biotechnology and industrial biotechnology to name a few. The faculties also have links/collaborations with scientists in India and abroad, and as a result the school has a publication record of over 80 research papers in the last six years. The laboratories are equipped with the latest equipments costing over Rs 4 crore.  The school  has Rs 3 crore as extramural funds with projects running in collaboration with DBT, DST, DRDO, AICTE and UGC. Every student is given a research topic during their final semester for doing inhouse research. The state-of-the-art 60-acre campus in Dwarka is in the pipeline where it is envisaged that new GLP compliant labs will be built up to attract industrial funding. The school also plans to actively pursue projects and collaborative programs in plant/animal/microbial functional genomics, stem cell biology and industrial biotechnology in the future. The alumnus of the biotech department have carved a place for themselves in prestigious institutes in India and abroad including University of Illinois, Ohio State University, Tufts University, Pennsylvania State University, North Carolina State University, University of Cambridge, IIT Chennai and IIT Mumbai. “We train our students to take on the world” —Prof. PC Sharma, dean, University School of Biotechnology  (USBT), GGSIPU According to you what is the USP of USBT? We are very careful in selecting our faculty members. Every faculty member holds a PhD. Usually, apart from the IITs, most of the faculties in biotechnology institutes are  teaching oriented, rather than research-oriented. Since ours is a government university, our endeavor is to make it a center of excellence in both teaching as well as in research, that is the emphasis at government universities. It is a challenge to create research facilities as it requires motivated, experienced faculties who can do independent research and also be able to attract funding to work on their projects. We have been actively working towards achieving that. What are the challenges facing biotech education in India? Biotechnology was touted as the next big thing after IT, but as far as education is concerned, we need to match the enthusiasm with upgradation of infrastructure and laboratory facilities and a greater awareness amongst students. Running costs are very low in IT, but in biotechnology, practical training is very important to make the students employable in the industry. Biotechnology is an infrastructure-based discipline, wherein a lot of investment is required in terms of laboratory equipment. Also there has to be a one-to-one interaction between the students and teachers to encourage students to do independent research. Today, many institutes are taking students in hordes while compromising on the quality of education, wherein, the students have no access to good laboratory facilities. Worse is that they charge heavily for the same unlike government institutes which have reasonable fees. What is your opinion on the talent crunch in terms of what is taught in the universities not being what the industry needs or is looking for? Industry needs to tell the institutes what they are looking for. We are ready to revise our syllabus to meet industry demands. Today, most of the biotech students are going for higher studies because they want to become scientists not technicians. Public-private partnership is the way forward wherein industry needs to forge greater partnership with the topmost universities to nurture talent. What have been some of the achievements at USBT? We train our students to take on the world. Our students have gone to prestigious research institutes such as NCBS, CCMB and IITs. Most of them have got fellowships in prestigious universities in the US with a fee waiver. We can proudly say, ours is the best government institute providing the best undergraduate study in biotechnology. The achievements of our students are a testament to that. We had a student qualify for Rhodes scholarship three years back. GATE 07 saw four out of the top 10 ranks from our department. Out of the 22 students who applied, 21 qualified GATE 07. Students also consistently perform well in GRE and NET exams. Shalini Gupta  ]]> <![CDATA[Rank 5 - Tezpur University]]> https://biospectrumindia.com/news/95/7076/rank-5-tezpur-university.html https://biospectrumindia.com/news/95/7076/rank-5-tezpur-university.html Thu, 06 Aug 2009 12:51:00 +0530 Rank 5 - Tezpur University Department of Molecular Biology and Biotechnology Tezpur University was established by an Act of Parliament in 1994. The Department of Molecular Biology and Biotechnology (MBBT) was started in July 24, 1997.  The department runs a two-year program leading to the master’s degree in MBBT. This department has been recognized by the Department of Biotechnology (DBT), Government of India, and granted accreditations for the postgraduate program. The objective of the department is to contribute to the advancement of the emerging areas of basic and applied life sciences and to create trained manpower in the field of molecular biotechnology. The integrated MSc program (five years) in bioscience and bioinformatics has been recently introduced in the department. The MSc program of the department is sponsored by DBT. Students are admitted through the all India combined biotechnology entrance examination. Out of 20 seats, eight are reserved for the domiciles of North East India. The library has 43, 080 volumes of print collection and subscribed 249 titles of current journals, 476 electronic journals through different consortium, two databases and one knowledge portal. The library provides access facility to 4,904 e-journals, two databases and one gateway portal provided by UGC-Infonet Digital Library Consortium of INFLIBNET Center. The university’s computer center has implemented a campus LAN with optical fiber backbone connecting the academic as well as administrative departments that spread over an area of 241 acres. ]]> <![CDATA[Rank 4 - Institute of Chemical Technology]]> https://biospectrumindia.com/news/95/2283/rank-4-institute-of-chemical-technology.html https://biospectrumindia.com/news/95/2283/rank-4-institute-of-chemical-technology.html Thu, 06 Aug 2009 12:48:00 +0530 Rank 4 - Institute of Chemical Technology Chemical Engineering Department The Mumbai University Institute of Chemical Technology (MUICT) offers four-year degree courses in chemical engineering (BChem Engg), in pharmacy (BPharm) and BTech in seven branches of chemical technology (dyes, foods, oils, paints, polymer, pharmaceutical and textile). Admission for all seats in India are filled by MUICT and the remaining seats are filled by the directorate of technical education (DTE), Government of Maharashtra. Admission for masters’ programs is in-line with the UGC norms and GATE is required as an eligibility criteria. For doctorate in engineering, technology, pharmacy and sciences, UGC/CSIR norms are followed for usual UGC sponsored seats as well as for endowment and other project positions. There are more than 200 merit-cum-mean scholarships by the alumni and industry.    The chemical engineering department of MUICT is known as one of the best chemical engineering schools in the world. There is a regular output of high quality research in the field of multiphase reactors, catalysis, bio separation, enzyme technology, environmental engineering, process intensification and process development.  The current research grants and interaction with the industry during the year 2004-2005 was an all time high. The faculty members obtain several research grants through prestigious national institutions and international collaborative research programs. Industrial consultancy is another unique feature of MUICT faculty members. Many faculty members pay out their salaries through the one-third share of the consultation fees to the university. ]]> <![CDATA[Rank 3 - Rajiv Gandhi Center for Biotechnology, Thiruvananthapuram]]> https://biospectrumindia.com/news/95/5789/rank-3-rajiv-gandhi-center-for-biotechnology-thiruvananthapuram.html https://biospectrumindia.com/news/95/5789/rank-3-rajiv-gandhi-center-for-biotechnology-thiruvananthapuram.html Thu, 06 Aug 2009 11:55:00 +0530 Rank 3 - Rajiv Gandhi Center for Biotechnology, Thiruvananthapuram A vibrant research hub RGCB has gained recognition as an international hub for biotechnology as it provides the right combination of research and development. With a dedicated team of talented scientific and technical personnel, RGCB offers a vibrant research atmosphere In the year 1990, Rajiv Gandhi Center for Biotechnology (RGCB) stepped into the capital city of Kerala, Thiruvananthapuram, a famous tourist destination.  The institute started amongst humble surroundings as a small charitable society called the Center for Development of Education, Science and Technology (C-DEST). In 1991, recognizing its potential, the C-DEST was made a grant-in-aid institute of the Government of Kerala and renamed as Rajiv Gandhi Center for development of Education, Science and Technology (RGC-DEST), becoming the country’s first institute to be named after the former Prime Minister late Rajiv Gandhi. On April 18, 1994, the Government of Kerala took the landmark decision to restructure the institute into a comprehensive biotechnology center and thus was created the Rajiv Gandhi Center for Biotechnology (RGCB). The institute, an autonomous national institute of the Government of India, was then managed by the state government’s committee for Science and Technology and Environment (STEC) and subsequently by the Kerala State Council for Science, Technology and Environment. Under the consistent guidance of the founding director, Dr M Ramachandra Das and his successor Dr RV Thampan, RGCB started growing in stature, infrastructure and research output. Moving at a warp speed with a well-defined path, RGCB has geared-up to fulfill the task of contributing to make India a knowledge power in biotechnology. With a  promise to reflect the future of Indian biotechnology, RGCB firmly pledges to fulfill its promise to the nation, which is ‘delivery discovery for India’.   The uniqueness of the institute is its vibrant research atmosphere with talented scientific and technical personnel, who have the privilege to avail excellent infrastructure facilities. RGCB has efficient corporate culture in R&D administration, in obtaining extramural funding and in project implementation. RGCB pursues to be an international hub for biotechnology, providing the right combination of research and development. The institute is also a store-house of a large number of molecular biology and biotechnological research instruments. RGCB’s library is a repository of valuable collection of many sought-after international books and journals on life sciences. In January 2009, RGCB  became the member of the Department of Biotechnology’s Electronic Library Consortia (DeLCON).  The institute has so far produced 39 doctoral thesis.  RGCB has a full-time faculty strength of 26, with 21 of them having a PhD. The faculty on an average has 30 national publications and 1,902 international publications. The department has six biotech-related patents to its credit. The department runs PhD programs, post-doctoral, specialized training programs including short-term PG courses. It is the top ranked institute on the infrastructure score. Some of the outstanding project or research works RGCB undertook in the recent years are on biomarkers for early detection of cancer, and development of specific targeted drug candidates for familial breast cancer, improvements in treatment by identifying primitive cancer cells during diagnosis and surgery, and screening of natural compounds for inhibiting hormones causing breast cancer. “Biotechnology will soon influence our lives in a number of ways” —M Radhakrishna Pillai, director, RGCB What are the major research activities that the center has introduced? RGCB has an excellent research ambience. Realizing that academic activity alone will not translate into biotechnology application, RGCB works with the industry from the beginning of an identified project instead of trying to find a partner longer way down or after having a product or process. We now have a joint technology development laboratory with the public sector, HLL Life Care, to develop point-of-care diagnostics for dengue fever. In August, 2009, RGCB will have another incubator to work on health and clinical informatics teaming with a software company. This sort of approach has made us understand biotechnology teaching and research in a different perspective allowing us to innovate much better. Over the years, what sort of changes have you seen in students? The outlook of students has changed in the last few years. PhD students now are much more picky and choosy about what they want. They come with definite ideas and expect much more out of an institute and the supervisor. Students are now conscious about publications and patents and have no hesitation in articulating these views. What are those changes that you brought to take the center to a higher level? We realized that to help students reach their goal, RGCB also has to adapt well. We have introduced mentoring committees for our PhD students. This committee with an external expert, two internal scientists and the thesis supervisor meets once every six months as part of the PhD program of a student. The committee provides advice and reviews the progress and coaxes the student into writing reports, publications and making effective presentations. The results have been very good. RGCB’s PhD students win awards regularly at conferences and meetings, go for international meetings (sometimes students here travel more frequently to international meetings than the faculty). In short, along with the research atmosphere, (the labs are open 24 hours, all essential infrastructure is always accessible, the regular open presentations by PhD students before the whole institute and the on-campus accommodation provided to students) the professional nature of institute management has made RGCB a favored destination of students seeking higher standards in learning biotechnology Anything you want to say to the present generation that will inspire them to pursue career in biotechnology? Biotechnology will soon influence our lives in a number of ways including the way food is produced and processed, human illness is treated and the way fuel is produced. Biotechnology is therefore truly a transformative technology comparable to some of history’s greatest events of creation including the invention of writing, the steam engine and electricity. Transformative technologies will always throw up challenges in governance and will need innovative thinking to frame questions and go about finding practical solutions. Anjana Pradhan ]]> <![CDATA[Rank 2 - University of Hyderabad, Hyderabad]]> https://biospectrumindia.com/news/95/2345/rank-2-university-of-hyderabad-hyderabad.html https://biospectrumindia.com/news/95/2345/rank-2-university-of-hyderabad-hyderabad.html Thu, 06 Aug 2009 11:47:00 +0530 Rank 2 - University of Hyderabad, Hyderabad School of Life Sciences A true blue talent Factory Being one of the premier institutes for pursuing postgraduation and research in biotechnology, UoH’s school of life sciences aims to  disseminate and advance biotech knowledge by providing instructional and research facilities that fit corporate needs. School of Life Sciences at the University of Hyderabad (UoH) is ranked second in this year’s survey. It is also ranked second in the faculty and industry interaction score. Admission to MSc biotechnology program is done through JNU joint entrance examination. The department has more than 44 faculty members, with 27 of being PhD holders and having more than five years of work experience. The biotechnology department has an excellent record of 46 national publications and 191 international publications to its credit. The school has multiple state-of-the-art laboratories for teaching and research in biology and biotechnology. It has invested Rs 3.60 crore for the year 2007-09. Students have access to advanced facilities like proteomics, genomics, bioinformatics and high-resolution microscopic facilities. Every teaching laboratory is equipped with sophisticated basic equipment for molecular and cell biology experiments, including culture, fermentation, proteomics and genomics. School of Life Sciences has the distinction of receiving the first-of-its-kind special funding from the Department of Biotechnology (DBT), Government of India, in the form of Center for Research and Education in Biology and Biotechnology. It has also received Rs 14.78 crore of government funded projects and Rs 9 lakh of industry-funded project between 2007-09. Research program of one of the faculty members is a part of the center of excellence on tuberculosis research funded by DBT to the tune of more than Rs 20 crore. Among other notable projects are, nanotechnology-based drug development under DST-sponsored nanotechnology initiative worth Rs 20 crore; DBT-sponsored project on development of peptide-based HIV therapeutics for Rs 90 lakh. Several other projects are funded by DST, DBT and ICMR  with funding ranging from Rs 25-50 lakh each. Recently, an Indo-US project on development of curcumin as HIV microbicide has been granted with a support of Rs 50 lakh to Indian side. The school offers seven post-graduate courses in biotechnology that include MSc in biotechnology, animal biotechnology, plant biology and biotechnology, MTech. in medical biotechnology and bioinformatics, integrated MSc in systems biology and also PhD program in biotechnology. About 160 students undergo training in the above courses every year. The candidates are selected on the basis of the very stringent criteria and procedures from amongst the applications received at an enviable average ratio of 1:150. The percentage of PG students from UoH, qualifying for their higher education at national level exams is quite high. For instance, seven out of 11 MSc biotechnology students, who appeared for the CSIR/NET exam in December 2008 were declared qualified. Many passed-out students from UoH are given admission into PhD programs in top universities elsewhere in the world. The school takes special interest to facilitate career opportunity for the students and invites various major companies like Biocon, Indian Immunologicals, Dr. Reddy’s Labs and TCS, for conducting placement interviews. The biotech department has 50 faculty members with a wide range of experience in India and abroad, spanning a spectrum of research topics in frontier areas of biology and biotechnology.  The entire faculty is successful in obtaining generous funding from multiple national and international agencies. “Students are oriented in the profession of their interest” —Prof. Anand K Kondapi, head, Department of Biotechnology, University of Hyderabad What are the unique features of the biotech department? Biotechnology department has its focus on molecular diagnosis and therapeutic development against infectious and neurodegenerative diseases. Faculty members in the department have already gained some leads in these areas of research as it is evident from their high impact publications. The department with a mixture of experimental and theoretical scientists working together in the interface research areas, to help in understanding molecular basis of disease that in turn lead to discovery of targets in disease progression. What are the new modules you have added to align your education with industry needs? The department has added remedial courses on basic mathematics, communication skills, IPR and biosafety, bioentrepreneurship and electives like protein engineering and protein folding, molecular therapeutics, stem cell biology, evolutionary genetics, vaccines, computational biology, industrial and food biotechnology for MSc biotechnology students. Can you tell us about the research projects that students or faculties have initiated at the biotechnology department? MSc students are working on various projects that include technologies like, molecular cloning expression, protein purifications including nanoparticle development, stem cell biology and understanding protein structure and function using NMR. Research projects of the faculties are funded by various national and international agencies like DBT, DST, India-US, Indo-German program; include biology of tuberculosis, HIV, stem cells, ribosome structure and function etc. with an aim to develop therapeutics and drug delivery. What are the initiatives taken by the institute to familiarize the students with the industry? The university is associated with conducting industry event BioAsia every year, where students are encouraged to participate in innovative project development as well as to interact with technocrats from industry. The university also conducts short visits to industry and experts from industry are involved in teaching lab-oriented courses such as bioprocess engineering and technology, and transgenic development. In addition, the department encourages the students to undergo summer training at the industries of their choice. What percentage of your students on an average get placements in biotech companies after post-graduation and how many prefer to go for higher studies? Students are oriented in the profession of their interest, in either research or in industry. Accordingly they have been mentored to place themselves for JRF test, advanced education aboard and in industrial training. What are your views on the current talent crunch in the biotech industry? There is a need for innovative and application-oriented project development to be implemented through cooperation between industry and academic institutions. It would be also useful to devise a training program particularly aimed at helping technical assistants, who could be absorbed in industry.  This will enrich the industry-oriented skills and promote knowledge and innovation. Jahanara Parveen ]]> <![CDATA[Rank 1 - Jawaharlal Nehru University, New Delhi]]> https://biospectrumindia.com/news/95/8344/rank-1-jawaharlal-nehru-university-new-delhi.html https://biospectrumindia.com/news/95/8344/rank-1-jawaharlal-nehru-university-new-delhi.html Thu, 06 Aug 2009 11:45:00 +0530 Rank 1 - Jawaharlal Nehru University, New Delhi School of Biotechnology High on industry interaction JNU’s school of biotechnology aims to generate a quality workforce to meet the country’s demands and has made untiring efforts to that end. Here is what makes it the No.1 public biotech institute in India. Jawaharlal Nehru University (JNU), New Delhi, was one of the first six universities in India to initiate a postgraduate teaching and research program in biotechnology in 1985, when a special Center for Biotechnology (CBT) under the joint sponsorship of the University Grants Commission (UGC) and the Department of Biotechnology (DBT), Ministry of Science and Technology, Government of India, was set up. The center was started to initiate biotechnology education program and was elevated to that of a school of biotechnology (SBT) in 2006. The school offers MSc and PhD in biotechnology. Students are admitted to the MSc program on the basis of an all India entrance examination conducted by JNU on behalf of 29 universities (where MSc in biotechnology program is supported by DBT) of the country. The program is supported by DBT and the total intake of students is 27. In addition to the theory courses, the program places emphasis on practical training. The MSc students undertake a two-semester research project work to orient themselves towards research in diverse areas of biotechnology. The PhD program has on its rolls 40 students. There are currently 11 faculty members in the school of biotechnology. The faculty members have continuously been able to attract extramural funding from different scientific agencies and biotechnology industries for running various research projects. The school has state-of-the-art instrumentation facilities including a central instrumentation facility, recombinant product development facility of GLP standard, spectroscopic facility, microcalorimetric facility, microscopic facility, protein production and purification facility and biosafety level 3 facility. The recombinant product development facility of GLP standards  was set up (RPDF-GLP) under the FIST support from the Department of Science and Technology (DST) and it has the flexibility to be used for the production of both recombinant products as well as the purification and characterization of non-recombinant products. The biosafety level 3 laboratory is being constructed with the financial support provided by the DBT. The laboratory will be used for research involving manipulation of biological infectious agents, both indigenous or exotic, which may cause serious or potentially lethal disease as a result of exposure to the inhalation route, with special emphasis on bacillus anthracis. The school of biotechnology holds the privilege of being the first university department of biotechnology to have transferred several technologies in the area of biotechnology, which are at advanced stages of commercialization with many more in the pipeline. Shalini Gupta ]]> <![CDATA[Rank 25 - Oxbridge College of Science and Commerce]]> https://biospectrumindia.com/news/95/1049/rank-25-oxbridge-college-of-science-and-commerce.html https://biospectrumindia.com/news/95/1049/rank-25-oxbridge-college-of-science-and-commerce.html Wed, 05 Aug 2009 16:48:00 +0530 Rank 25 - Oxbridge College of Science and Commerce Oxbridge College of  Science and Commerce, which comes under the umbrella of Oxbridge Group of Institutions, was established in the year 1998.  Affiliated to the Bangalore University, the college is recognized by the Government of Karnataka. The institute started BSc course in biotechnology in 2002 and MSc in 2006.  For admission in MSc in biotechnology, a candidate must have passed BSc degree with a minimum of 50 percent of marks in all the three optionals in aggregate. The applicant should have studied chemistry or biochemistry as a compulsory subject along with other science subjects like biotechnology, environmental science, zoology/ applied zoology, botany/ applied botany, sericulture, life science/ biological science, to list a few. Duration of the course is two years which is divided into four semesters. Student intake in both the courses i.e., BSc and MSc is 30 each. The college possess well-equipped laboratories in each department. Each student is provided with the necessary equipment for individual experimentation in the practical classes. The library has nearly 5,000 text books and reference books. It also has subscription to 12 magazines, 17 scientific journals and periodicals of both national and international repute. ]]> <![CDATA[Rank 24 - Dayananda Sagar College of Biological Sciences]]> https://biospectrumindia.com/news/95/2878/rank-24-dayananda-sagar-college-of-biological-sciences.html https://biospectrumindia.com/news/95/2878/rank-24-dayananda-sagar-college-of-biological-sciences.html Wed, 05 Aug 2009 16:47:00 +0530 Rank 24 - Dayananda Sagar College of Biological Sciences Dayananda Sagar College of Biological Sciences is an integral part of Dayananda Sagar Institutions and has biotechnology, microbiology, biochemistry, genetics and zoology as core subjects. The biological sciences discipline has well-qualified and experienced faculties. The college offers postgraduate and undergraduate courses and it also offers faculty development programs, seminars, workshops and interactive sessions with experts from industry and research sectors. A science festival named Biomic is held as annual event with large participation. National and international conferences like STEM 2005 are also organized in association with other research and academic bodies. The department has state-of-the-art laboratories, which are spacious and placed with modern equipments and instruments. The departments are supported by excellent library with well-stocked books across a broad spectrum of subjects, and with modern computer center catering to the needs of students and helping them to meet the current and future needs of biosciences. Professors of the department have made several research project proposals on the current advances on topics such as stem cell research, environmental studies, plant biotechnology and human genetics. To stay in tune in the competitive world, students are encouraged to take up project works at various reputed research institutes and corporates such as Biocon, Indian Institute of Science, University of Agricultural Sciences, Indian Institute of Horticultural Research, Central Food Technological Research Institute, AstraZeneca, Avastagen, ITPL Park, Natural Center for Biological Sciences (NCBS), Jawaharlal Nehru Center for Advanced Scientific Research, Molecular Connections, GVK Biosciences, Indian Veterinary Research Institute (IVRI), and Raghavendra Biotechnologies. ]]> <![CDATA[Rank 23 - T John College]]> https://biospectrumindia.com/news/95/1785/rank-23-t-john-college.html https://biospectrumindia.com/news/95/1785/rank-23-t-john-college.html Wed, 05 Aug 2009 16:42:00 +0530 Rank 23 - T John College T John College was established by T John, the ex-minister of state for infrastructure development and aviation in Karnataka. T John’s initiative has also led to the formation of  Marougen Education Foundation in 1988. The department of biotechnology at  T John College offers bachelors and masters degrees in biotechnology. From the year 1996, the college offers BSc in biotechnology, which is recognized by Bangalore University; from the year 2001, the college offers MSc in biotechnology, which is recognized by Bangalore University; and from the year 2004, the college offers MPhil in biotechnology, which is recognized by Bharathidasan, Annamalai and Dravidian universities. The student intake capacities for BSc, MSc and MPhil courses are 32, 45 and four respectively. The college has five dedicated biotech laboratories, which can accommodate 30 students each. Students who successfully complete their course at the college will get a placement opportunity. ]]> <![CDATA[Rank 22 - Padmashree Institute of Management Studies]]> https://biospectrumindia.com/news/95/1807/rank-22-padmashree-institute-of-management-studies.html https://biospectrumindia.com/news/95/1807/rank-22-padmashree-institute-of-management-studies.html Wed, 05 Aug 2009 16:40:00 +0530 Rank 22 - Padmashree Institute of Management Studies Padmashree Institute of  Management Studies is part of the Padmashree Charitable Trust, which was formed in 1994. The first institution to be started by the trust was Padmashree Institute of Physiotherapy in 1996—the first physiotherapy institute to be started in Bangalore. The institute is affiliated to Bangalore University. The institute offers a wide range of courses from health sciences to life sciences and is fully-equipped with plant biotechnology, microbiology and biochemistry labs. The courses offered by the institute include BSc and MSc in biotechnology, pharmacy and microbiology. The undergraduate and postgraduate courses of the institute are integrated with Bio dHRona, an industry-oriented module designed in collaboration with industries. The practical training imparted through department seminars, workshops and industry visits at this college help to enhance the skills of students. ]]> <![CDATA[Rank 21 - Gokaraju Rangaraju Institute of Engineering and Technology]]> https://biospectrumindia.com/news/95/1114/rank-21-gokaraju-rangaraju-institute-of-engineering-and-technology.html https://biospectrumindia.com/news/95/1114/rank-21-gokaraju-rangaraju-institute-of-engineering-and-technology.html Wed, 05 Aug 2009 16:37:00 +0530 Rank 21 - Gokaraju Rangaraju Institute of Engineering and Technology Gokaraju Rangaraju Institute of Engineering and Technology is affiliated to Jawaharlal Nehru Technological University, Hyderabad. The department of biotechnology was established in the year 2002 with an intake of 30 students. This course is aimed to explore and exploit biological resources, and produce varied range of useful products.  The department offers a BSc course.  Ninety students were enrolled for the academic year 2008-2009.  At present, there are 13 full-time faculty members with seven members having an experience of more than five years. The department has laboratories using engineering technology in bio-chemistry and cell biology lab, microbiology lab, instrumental methods of analysis lab, plant tissue culture lab, bio-process lab-I, bio-process engineering lab-II, molecular biology and genetic engineering lab, downstream processing lab, immunology lab and bioinformatics lab. The institute also comes up with journals both national and international. It also brings in visiting faculty members and at present there are four faculty members with a work experience of more than four years. The industry has been sponsoring some of its projects. ]]> <![CDATA[Rank 19 - Banasthali University]]> https://biospectrumindia.com/news/95/7851/rank-19-banasthali-university.html https://biospectrumindia.com/news/95/7851/rank-19-banasthali-university.html Wed, 05 Aug 2009 16:32:00 +0530 Rank 19 - Banasthali University Banasthali is one of the five universities in India meant exclusively for women. It is accredited by National Assessment and Accreditation Council (NAAC) with ‘A’ Grade (Five star Rating). In 1991, the university started its MSc Bioscience and MSc Biotechnology in 1994.       The first PhD student was registered in 1997. Within a short span, the department made rapid strides in major thrust areas of research in bioscience and biotechnology. Some of the major areas of research are plant and agricultural biotechnology, plant tissue culture, microbial biotechnology, restoration & physiological ecology, immunology, plant pathology, enzymology, bioinformatics. Some of the current research topics are: biochemical basis of plant disease resistance; stress adaptation of plants, reclamation of fluoride-rich soils using plants; tissue culture of arid zone species, role of trophic hormones in reproductive physiology, pesticides biodegradation, biofertilizers. A research collaboration  on stress biotechnology was carried out between the laboratory of prof  Vinay Sharma and prof Ulrich Luettge of Darmstadt University Germany. ]]> <![CDATA[Rank 18 - SRN Adarsh College]]> https://biospectrumindia.com/news/95/1843/rank-18-srn-adarsh-college.html https://biospectrumindia.com/news/95/1843/rank-18-srn-adarsh-college.html Wed, 05 Aug 2009 16:29:00 +0530 Rank 18 - SRN Adarsh College SRN Adarsh College is part of Adarsh Group of Institutions, which was established in 1971. The college is affiliated to Bangalore University and accredited by the National Assessment and Accreditation Council (NAAC). It is also approved by the All India Council for Technical Education (AICTE) and is ISO 9001-2000 certified. In the life sciences stream the college offers MSc in biotechnology.  The state-of-the-art laboratory at the college is well-equipped with modern lab equipments that facilitate research activities of the biotech students. As part of the curriculum, students are given practical and acadmical training for developing their skills and expertise in various streams of biotechnology. The faculties with their experience in imparting knowledge will inspire students to build up a successful career in biotechnology. Other than MSc in Biotech, SRN Adarsh College offers BSc in biotech and biochemistry. ]]> <![CDATA[Rank 17 - Arunai Engineering College]]> https://biospectrumindia.com/news/95/7809/rank-17-arunai-engineering-college.html https://biospectrumindia.com/news/95/7809/rank-17-arunai-engineering-college.html Wed, 05 Aug 2009 16:29:00 +0530 Rank 17 - Arunai Engineering College Arunai Engineering College (AEC) was established in 1993. At present, the institution has 2,492 students. The college offers nine undergraduate engineering programs and six postgraduate programs. The National Board of Accreditation (NBA) of AICTE,  New Delhi, had awarded it with the requisite accreditation. Arunai Engineering College has also been awarded ISO 9001:2000 certification from DNV Netherlands in recognition of its International Quality Standards in technical education. Further, to enhance the level of interaction with the industry, Arunai Engineering College has become a member of Confederation of Indian Industry. Academic courses in Bachelor of Engineering include mechanical engineering, computer science and engineering, electrical and electronics engineering, electronics and communication engineering, electronics and instrumentation engineering, civil engineering. In Bachelor of Technology, it offers information technology, chemical engineering, industrial biotechnology. During the year, students of AEC underwent training on handling aptitude tests, group discussions, interview handling and resume preparation through leading training partners. ]]> <![CDATA[Rank 16 - Dr DY Patil Biotechnology & Bioinformatics Institute]]> https://biospectrumindia.com/news/95/5404/rank-16-dr-dy-patil-biotechnology-bioinformatics-institute.html https://biospectrumindia.com/news/95/5404/rank-16-dr-dy-patil-biotechnology-bioinformatics-institute.html Wed, 05 Aug 2009 16:22:00 +0530 Rank 16 - Dr DY Patil Biotechnology & Bioinformatics Institute Dr DY Patil University which has been conferred a deemed university status, offers courses in biotechnology and bioinformatics through its institute namely the Dr DY Patil Biotechnology & Bioinformatics Institute. The institute offers a BTech in biotechnology and bioinformatics and MTech (integrated) in biotechnology. Its biotechnology labs are equipped with laboratory facilities in biochemistry, biotechnology, molecular biology, animal tissue culture and plant tissue The bioinformatics is well equipped with high speed computers, application software and internet facilities. These give excellent opportunity for creation of young graduates with sound theoretical and practical basis for venturing into 21st century problems. ]]> <![CDATA[Rank 15 - Presidency College]]> https://biospectrumindia.com/news/95/5607/rank-15-presidency-college.html https://biospectrumindia.com/news/95/5607/rank-15-presidency-college.html Wed, 05 Aug 2009 16:18:00 +0530 Rank 15 - Presidency College Presidency College, Bangalore, founded by the Presidency Group of Institutions, is affiliated to the Bangalore University and offers undergraduate and postgraduate courses. In life sciences stream, the college offers BSc and MSc in biotechnology. MSc in biotechnology was started in 2002 and it has an intake capacity of 25 students. Dedicated faculties with their subject expertise will guide aspiring biotech students towards attaining their career goal to perfection. Eight faculties of the biotech department have more than five years of experience in moulding out excellent students and from June 2003-May 2007, 10 research papers were published in international journals including one in national journal. There are four dedicated laboratories available at the college for biotech students, each lab can accommodate up to 30 students at a time. All the four laboratories are equipped with modern lab equipments that keep track with the changing  needs of biotech research. The library at the college has a collection of national and international scientific journals. The eligibility criteria for MSc admission includes a BSc degree with minimum of 50 percent aggregate marks and chemistry as a compulsory subject.    ]]> <![CDATA[Rank 13 - Shoolini Institute of Life Sciences and Business Management]]> https://biospectrumindia.com/news/95/1249/rank-13-shoolini-institute-of-life-sciences-and-business-management.html https://biospectrumindia.com/news/95/1249/rank-13-shoolini-institute-of-life-sciences-and-business-management.html Wed, 05 Aug 2009 16:02:00 +0530 Rank 13 - Shoolini Institute of Life Sciences and Business Management Shoolini Institute of Life Sciences and Business Management (SILB) is the culmination of a life-long dream of several internationally renowned academicians and business leaders. A dream to help build India’s burgeoning life sciences, biotechnology and bio-based industries by developing a world class institute. SILB is affiliated to Himachal Pradesh University, Shimla and recognized as a Scientific and Industrial Research Organization by the Ministry of Science and Technology, Government of India.    The faculty of the institute has vast experience in formulating and handling biotechnology related national and international projects, under the overall guidance of Prof PK Khosla, former vice-chancellor, HPAU, Palampur and ex-advisor, Biotechnology, Govt of Himachal Pradesh. ]]> <![CDATA[Rank 12 - Bannari Amman Institute of Technology]]> https://biospectrumindia.com/news/95/2902/rank-12-bannari-amman-institute-of-technology.html https://biospectrumindia.com/news/95/2902/rank-12-bannari-amman-institute-of-technology.html Wed, 05 Aug 2009 16:01:00 +0530 Rank 12 - Bannari Amman Institute of Technology Bannari Amman Institute of Technology  is an autonomous university affiliated to Anna University. The Department of Biotechnology was established in the year 2003. It offers the full-time four-year BTech program in biotechnology as well as the full-time two-year MTech program in biotechnology. The BTech curriculum provides an equal mix of life sciences, chemical engineering, and bioprocess engineering subjects and labs. The department has been recognized by Anna University as a collaborative research center for the PhD program. Laboratory facilities offered include areas like biochemistry, bioorganic chemistry, microbiology, chemical engineering, cell biology, bioprocess engineering, molecular biology, genetic engineering, immunology, downstream processing, bioinformatics, instrumental analysis. During summer vacation, the department of biotechnology, has been sending third and fourth semester students for summer internship at Syngenta Seeds AB, Sweden. The trainees acquire research skills in various areas of seed pathology, germplasm enhancement, marker-assisted breeding, genetic engineering, genomics, biochemistry and cell biology. ]]> <![CDATA[Rank 11 - Jaipur National University]]> https://biospectrumindia.com/news/95/4002/rank-11-jaipur-national-university.html https://biospectrumindia.com/news/95/4002/rank-11-jaipur-national-university.html Wed, 05 Aug 2009 15:56:00 +0530 Rank 11 - Jaipur National University As per the Ordinance 7 of 2007, promulgated by the Government of Rajasthan, the Mahima Shiksha Samiti of Jaipur established Jaipur National University, on October 22, 2007. Approved by the UGC Under Sec 2f of UGC Act 1956, the university which is the apex body of 14 schools and various departments organize teaching and research projects under the supervision and guidance of their respective directors and heads of the departments.  School of Life Sciences at Jaipur National University offers various postgraduate programs leading to MSc, MPhil and PhD degrees. The programs are in biotechnology, microbiology and biochemistry. It offers a three-year integrated BSc Biotech course, five-year integrated BSc, MSc Biotech and a two-year MSc Biotech courses. Integrated programs in Biotechnology, Microbial Technology and Bioinformatics have been devised to provide a broad-based curriculum with interdisciplinary approach as well as in-depth understanding of effective and innovative practices. ]]> <![CDATA[Rank 10 - Shree Manibhai and Smt Navalben Virani Science College]]> https://biospectrumindia.com/news/95/2511/rank-10-shree-manibhai-and-smt-navalben-virani-science-college.html https://biospectrumindia.com/news/95/2511/rank-10-shree-manibhai-and-smt-navalben-virani-science-college.html Wed, 05 Aug 2009 15:54:00 +0530 Rank 10 - Shree Manibhai and Smt Navalben Virani Science College Shree Manibhai and Smt Navalben Virani Science College, affiliated to Saurashtra University has been accredited at the “A” Level by NAAC & STAR College by DBT. It offers BSc and  MSc courses in biotechnology.  While the former had a student intake of 120 students this year, the latter provided admission to 40 students. SKS runs many institutions, which provide education from KG to PG. The institute which introduced B Sc in biotechnology in 1999,  has a good range of laboratory equipment and specialized laboratories for tissue culture, microbiology, pathology, biotechnology, biochemistry and biology. As part of its post-graduate programs, the institute also conducts minor research. Students are enrolled by common entrance test conducted by the institute followed by personal interview. ]]> <![CDATA[Rank 9 - PES Institute of Technology]]> https://biospectrumindia.com/news/95/2069/rank-9-pes-institute-of-technology.html https://biospectrumindia.com/news/95/2069/rank-9-pes-institute-of-technology.html Wed, 05 Aug 2009 15:51:00 +0530 Rank 9 - PES Institute of Technology PES Institute of Technology, started its BE in biotechnology course in 2002. Peoples Education Society was established in 1972 and it runs a group of institutions that offer diploma, undergraduate and post-graduate degree programs in commerce, engineering, management, medicine, pharmacy and science disciplines. The department of biotechnology at the institute has a well-established infrastructure and comprises nine laboratories in the areas of cell and microbiology, biochemistry, molecular biology, immunology, animal and plant tissue culture, upstream & downstream processing, unit operations, momentum transfer. The courses offered by the biotech department are MPharm, MSc in biotechnology, MSc in medical microbiology and medical pharmacology. PES School of Engineering, which offers BE in biotechnology course, has a state-of-the-art facility providing the right ambience that ensures the best of teaching, learning and research engagements. ]]> <![CDATA[Rank 8 - Acharya Institute of Sciences]]> https://biospectrumindia.com/news/95/2855/rank-8-acharya-institute-of-sciences.html https://biospectrumindia.com/news/95/2855/rank-8-acharya-institute-of-sciences.html Wed, 05 Aug 2009 15:40:00 +0530 Rank 8 - Acharya Institute of Sciences Acharya Institute of Sciences is affiliated to Bangalore University, which has been given five star accreditation by National Assessment and Accreditation Council (NAAC) of University Grants Commission. The institution was established in the year 2001 and offers Bachelors and Masters Degree in biotechnology, genetics and microbiology. BSc, (B,C,G), (G,B,B) and (M,B,G) are the courses offered. A new combination proposed for 2009-10 is computer science, biotechnology and biochemistry. Students are acquainted with practical day-to-day clinical and analytical problems and issues through frequent seminars, workshops and study projects in their chosen field of work. Every student is required to present a seminar on an allotted topic, every semester. During the academic year, special lectures by eminent scientists are arranged for the benefit of the students. The colleges have extensive laboratory facilities in the campus with all the required state-of-the-art equipment and systems to enable students to conduct experiments scientifically. The laboratories also contain valuable specimens and samples to enable detailed study and analysis. ]]> <![CDATA[Rank 7 - The Oxford College of Science]]> https://biospectrumindia.com/news/95/2697/rank-7-the-oxford-college-of-science.html https://biospectrumindia.com/news/95/2697/rank-7-the-oxford-college-of-science.html Wed, 05 Aug 2009 15:35:00 +0530 Rank 7 - The Oxford College of Science The Oxford Educational Institutions was founded in 1974 by S Narasu Raju. The institutions cater to the needs of postgraduate students. The department of biotechnology at the Oxford College of Science offers MSc in biotechnology, which is affiliated to Bangalore University. It also offers MPhil in biotechnology, which is recognized by the Periyar University. The institute offers placement opportunities in renowned biotech companies. The total yearly intake for MSc course is 40 and six each for MPhil courses. As part of the postgraduate course in biotechnology, students will be trained to perform all requisite chemical, biochemical and microbiological analysis of raw material and finished product. The courses also impart technical knowledge in the area of biochemistry, microbiology, immunology, genetics, genetic engineering, enzyme technology, molecular biology, plant and animal biotechnology. ]]> <![CDATA[Rank 4 - Amity Institute of Biotechnology, Noida]]> https://biospectrumindia.com/news/95/1361/rank-4-amity-institute-of-biotechnology-noida.html https://biospectrumindia.com/news/95/1361/rank-4-amity-institute-of-biotechnology-noida.html Wed, 05 Aug 2009 14:56:00 +0530 Rank 4 - Amity Institute of Biotechnology, Noida Up-to-date tailored courses Amity Institute of Biotechnology is perhaps the largest private university providing biotech education in the country and is continuously striving to give the most advanced courses to its students. Industry-centric curriculum of this institute enhances the professional skills of the students. Amity Institute of Biotechnology (AIB) is located on the sprawling Amity Campus at Sector 125 in Noida and was established in August 2001. The institute was awarded with ISO-9001 and 14001 certifications for its quality and environmental management systems applicable to biotechnology education, training and research by Botanical Survey of India (BSI) in 2007. The institute offers BSc in biotechnology and medical biotechnology, BTech in biotechnology and bioinformatics, dual degree in biotechnology, MSc in bioinformatics, MSc, MBA and MTech in biotechnology. The institute has a strength of 126 faculty members for its 58 specialized courses. Dr PK Paul, a faculty member says, â€œEvery theory subject is supplemented by a practical. We update the syllabus in May/June every year depending on the feedback from the industry. We have an extensive international collaboration with universities like the University of Abertay, Dundee; Napier University, and University of Ulster.â€? Practical examinations are conducted by external examiners from Jawaharlal Nehru University (JNU), International Center for Genetic Engineering and Biotechnology (ICGEB) and so on. The institute also has value addition courses wherein a student has to learn a foreign language, a compulsory course in English and behavioral sciences. AIB possesses the most modern infrastructure in terms of tissue culture labs, microbiology, central instrumentation facility, computational biology, biochemical techniques and molecular biology. Further, a 60-acre herbal garden with greenhouse facilities, a well-stocked library and state-of-art computing room, facilitate research and consultancy. The institute is equipped with 34 biotechnology (including 10 research laboratories) and nine bioinformatics laboratories. Some specialized laboratories are available for cell biology and genetics, enzymology, molecular biology, recombinant DNA technology, microbiology, animal biotechnology, animal cell culture, plant biotechnology equipped with plant tissue culture facility, immunology, genomics, proteomics and bioprocess technology. The laboratories are equipped with state-of-art equipments like gel documentation system, CO2 incubator, -86oC refrigerator, ELISA readers, ultracentrifuge, tissue sonicator, tissue homogenizor and Peltier regulated UV-VIS spectrophotometer. AIB is concentrating on research in thrust areas such as life processes related to health care, diagnostic and therapeutics, functional foods and nutraceuticals, environment remediation, biodiversity and energy conservation which are being monitored through 12 well-specialized centers for plant genetic engineering, genomic, drug discovery and innovation, bioinformatics, nanobiotechnology, population studies and human genetics, bioprocess technology and enzymology, and cell and molecular biology. Students have been awarded fellowship for PhD in University of Ulster, North Ireland and Finland as part of the joint initiative with ICGEB. Three major companies working in various areas of bioinformatics viz. Mascon Global, New Delhi; Helix Genomics, Hyderabad; and Accelrys, Bangalore; have been in close touch with AIB and are keen on signing MOUs for collaborative projects. MBA in biotech management was the first of its kind course in South East Asia started at AIB in 2003. The course curriculum comprises 40 percent industry-oriented biotechnology and 60 percent management with emphasis on marketing. Around 40 percent of students who pass out from AIB move to the corporate sector and it has been found that their feedback has helped the industry to improve their product. About 60-65 percent of the students completing BTech and MSc in AIB go abroad for studying PhD and MS courses. Students have the confidence and the knowledge to branch out into specialized fields of study, opined prof Srivastava, director, AIB. AIB recently inked a collaboration with Imperial Life Sciences to train students in using the latest technological instruments. These students are either absorbed in ILS or in other biotech companies. The university currently has 25 patents to its credit. 'We give students the best technical education' -Prof AK Srivastava, director, Amity Institute of Biotechnology What are the current challenges in biotech education? Students in B Sc and BTech biotechnology should have a background in the allied and introductory areas of biotechnology. The syllabus has to be revised in such a way that students get a knowledge of introductory biology at the school level so that they can learn about the basics of biotechnology at the graduate level and then apply them at the postgraduate level to gain greater in-depth understanding of the subject. We have had positive interactions with the industry but there has to be a greater interaction between the industries, research institutes and the academia. To promote that, we have an incubator in our school that is in constant touch with the industry. What is the uniqueness of education at AIB? Our programs are tailored to give students the best technical education in biotechnology. This gives them exposure to the core specialized areas of biotechnology such as agricultural biotechnology, food biotechnology and environmental biotechnology. Exposure to the core specialized areas along with industry exposure help students to carve a niche for themselves. One of the areas we are working on is drug discovery and development of active biomolecules for curing different diseases. A product has been developed for the same which has been patented. We have identified a plant (Dhatura delta) which has the potential to control Helicobacter pylori that causes peptic ulcer. The active principle has been identified and clinical trials are yet to be started. We are also working on developing a chemically synthesized molecule for breast cancer. Most of our faculty is involved in developing such cutting-edge projects. What is your vision for the future? Most of our students, either biologists or chemists, are working on drug discovery and molecule identification. The integration of both the disciplines is what is needed. So keeping that in view, we are going to start a school of chemical biology for which the course syllabus has already been developed. This course will have modules from structural biology and organic chemistry. We plan to start an MSc program from next year. We are going to strengthen MSc in medical biotechnology course by offering it along with bioinformatics as a minor subject, since a knowledge of bioinformatics is required by students in this stream to equip them better with the needs of the industry in which they work. Shalini Gupta ]]> <![CDATA[Rank 3 - Jaypee Institute of Information Technology, Noida]]> https://biospectrumindia.com/news/95/7279/rank-3-jaypee-institute-of-information-technology-noida.html https://biospectrumindia.com/news/95/7279/rank-3-jaypee-institute-of-information-technology-noida.html Wed, 05 Aug 2009 14:11:00 +0530 Rank 3 - Jaypee Institute of Information Technology, Noida Center of excellence Jaypee Institute has emerged as the center of excellence in the emerging areas of education, including biotechnology, and has been creating professionals who lead in innovation, entrepreneurship, creativity and management. Jaypee Institute of Information Technology University is a deemed university under Section 3 of UGC Act. 1957 vide Notification No. F.9-27/2000-U.3 dated November 1, 2004 of the Ministry of Human Resource Development, Government of India. It is the first amongst three Institutes of higher technical education, raised by the Jaiprakash Sewa Sansthan (JSS). The state-of-the-art campus over a total built up area of over 7,45,272 sqm comprises smart buildings with internet and Wi-Fi connectivity including environmentally conditioned academic block, Annapurna (Mess), well-equipped laboratories, Learning Resource Center, faculty and student residences. The university offers doctoral, post-graduate as well as undergraduate programs in the disciplines of computer science engineering, information technology, electronics and communication engineering and biotechnology. The university also has various dual degree programs offered by departments of biotechnology, computer science engineering and Jaypee Business School. Currently, the university offers a four-year BTech in biotechnology as well as a five-year integrated course (BTech and MTech, BTech MBA) in biotechnology. The laboratories are equipped with the latest scientific equipments and state-of-art software packages for analysis of biomolecules in drug discovery (In silico). The laboratory space has been specially designed to accommodate Thermocyclers, Gel documentation systems, CO2 incubators, deep freezers, Laminar Hoods, BOD incubators, Kuhner incubators, Lyophilizers, cold centrifuges, fermentors, walk-in cold rooms, Microplate Readers, pH meters, electrophoretic equipments, binocular microscopes and inverted microscopes with micro-manipulators. The university's Learning Resource Centre has around 24,050 volumes of books and is house to over 4,000 e-journals covering disciplines like computer science, information technology, biotechnology, mathematics, physics and materials science, humanities, management and other areas related to engineering, science and technology. The collection comprises printed documents such as books, reports, theses, standards, atlases, patents and previous issues of journals. The non-book collections include material like audio/video cassettes and CD-ROM discs etc. RIBOSE â€“ The Biotech Society of JIITU was launched on November 16, 2007 as a wing of Jaypee Youth Club. Shalini Gupta ]]> <![CDATA[Jaypee University of Information Technology, Solan]]> https://biospectrumindia.com/news/95/7776/jaypee-university-of-information-technology-solan.html https://biospectrumindia.com/news/95/7776/jaypee-university-of-information-technology-solan.html Wed, 05 Aug 2009 14:10:00 +0530 Rank 2 - Jaypee University of Information Technology, Solan Strong on research, faculty Emphasizing on learner-centric education process, JUIT has carved out a niche for itself as one of the prominent biotech institutes in the country. The quality of research initiatives have made JUIT what it is today. Jaypee University of Information Technology (JUIT), was set up by Act No.14 of 2002 vide Extraordinary Gazette notification of Government of Himachal Pradesh dated May 23, 2002. It has been approved by the University Grants Commission (UGC) under section 2(f) of the UGC Act. The university commenced academic activities from July 2002 with undergraduate BTech degree programs in electronics and communication engineering, computer science and engineering, information technology, bioinformatics, and civil infrastructure engineering (from July 2003). The department of biotechnology offers four-year BTech programs in biotechnology and bioinformatics, a dual degree five-year MTech program in biotechnology and a six-year dual degree BPharm-MPharm practice. The department receives close to 4,000 applications for 90 seats. The bioinformatics curriculum includes courses on algorithm design, machine learning, computational high throughput screening and drug designing, bioprogramming and scripting languages. The bioinformatics graduates have an added advantage of working in biotech, bioinformatics, pharmacy and IT industries. The department is equipped with 12-15 labs providing hands-on training in various areas of biotechnology such as medical biotechnology, industrial biotechnology, environmental biotechnology, food biotechnology, agricultural biotechnology, plant biotechnology, pharmaceutical biotechnology, genomic and proteomic technologies, animal and plant cell culture technologies. The department is actively involved in research having the distinction of running externally funded R&D projects worth Rs 4 crore from various government agencies such as the department of biotechnology, department of science & technology, DRDO, ministry of environment and forest, and an industry, AyurVet Baddi, sponsored project. In the field of medical biotechnology, the department is working on identification of drugs from native medicinal plants of the Himalayas, development of diagnostics for infectious diseases such as TB and hepatitis and vaccines for common diseases in India. An R&D program on jatropha to identify strains that could help in the production of biodiesel is also underway. The department has a strong doctoral research program wherein 19 PhD scholars are registered with faculty members. There are 30 faculty members in various areas. The placement of graduates has been more than 95 percent during the last three years with most of the students being offered jobs in more than one industry. Many BTech graduates from the university are pursuing MS /PhD degrees in the top class universities in the US and Europe. BTech final year students work on a project for the next two semesters and have to write an international paper on the basis of which they are graded. ‘We are looking at greater interaction with the industry’ —Prof. RS Chauhan, head, Department of Biotechnology and Bioinformatics, Jaypee University of Information Technology What is the uniqueness of biotech courses offered by Jaypee Institute? Undergraduate education in biotechnology requires providing skills to the students in diverse areas of biotechnology such as medical, industrial, environmental and food biotechnology to name a few. Apart from IITs, very few institutes have varied faculty profile to provide for the same. We not only have faculty in different areas of biotechnology  but even the curriculum is diverse and formulated keeping in mind the requirements of the academia and the industry. Our faculty has a high record of publications in top national and international journals along with exposure to international conferences. What are the projects underway at the department? Many plants are becoming endangered in the Himalayas due to the proliferation of pharma companies in the region which are using them to extract medicinal compounds.  Hence, we are conserving those plants through tissue culture. In environmental biotechnology, we are working towards bioremediation of electronic waste such as used PCs, mobiles etc., to extract metals from them using microbes that help in the degradation of electronic waste. We have also converted vermi compost made form waste plants (left after usage in labs) to bioethanol at a lab scale. In nutraceuticals, we are working on making wines from sea-buck thorn, a native plant. We have two patents to our credit —one for the production of medicinal compounds through tissue culture and the other for using henna as a dye for staining electrophoresis gels. We are running a project with DRDO in the area of bioweapons. It is believed that pathogens such as bacillus anthracis can be multiplied and then used in biowarfare. Hence, we are working at identifying vaccine candidates common to these pathogens to develop a common vaccine that can fight it. What is the need of the hour in biotechnology education? Dr MK Bhan, secretary, DBT, once rightly commented that “we are creating more of technicians and less of scientists”. Most of the universities today have come up with courses without good infrastructure and trained faculty, which is important if our educational institutions are serious about imparting good quality education. Also, the courses have to be tailored according to the requirement of the industry and should be revisited according to the current trends, time and again. We at Jaypee are looking at strengthening our infrastructure, research and faculty while aiming at providing students exposure in different branches of biotechnology. We are also looking at greater interaction with the industry and search for high priority areas of research and formulate projects in those areas.  Shalini Gupta ]]> <![CDATA[Sastra University]]> https://biospectrumindia.com/news/95/5908/sastra-university.html https://biospectrumindia.com/news/95/5908/sastra-university.html Wed, 05 Aug 2009 13:36:00 +0530 Rank 1 - Sastra University, Thanjavur Sastra, best of the breed Sastra University made it to No.1 postion in the BioSpectrum Top 20 Biotech Institutes Survey. It’s School of Chemical and Biotechnology also tops faculty and infrastructure ranking. The School of Chemical and Biotechnology at Sastra University offers undergraduate programs in bioengineering, bioinformatics, biotechnology and chemical engineering and postgraduate programs in bioinformatics, chemical engineering and industrial biotechnology, besides PhD programs. The institute has also started medical and nanotechnology programs. The department has 92 faculty members with 43 of them possessing PhD degree and with over five years of teaching experience. The department has published 51 scientific publications in national and international journals between 2007-09. The department has more than 20 laboratories. The total investments in lab equipments and consumables are estimated at over Rs 6.78 crore for the year 2007-09. “The excellent infrastructure coupled with an industry-oriented curriculum and expert faculty is reflected in the research output in the form of patents, publications and success rates of the students,” says Dr Swaminathan, director, Center for Nanotechnology and Advanced Biomaterials, and dean, sponsored research, Sastra University. The placement record of the students is more than 90 percent and many students are pursuing research in premier research institutions across the world. The department has externally funded research projects worth Rs 20.56 crore from the government in various areas of biotechnology and industry sponsored projects worth Rs 38 lakh. With a focus on the traditional strengths in engineering and with emphasis on experiential learning, the university offers innovative academic programs and continuously upgrade their curricula.  The goal of the university is to provide the best undergraduate and postgraduate education, with programs designed to prepare the candidates to meet the challenges they come across throughout their professional career.  The school provides excellent infrastructure and a conducive environment for learning and is equipped with state–of–the–art laboratories, experienced faculty and a curriculum tailored to suit industrial needs. The programs offered by the school prepare students for leadership in the development and commercialization of advanced technologies and strive to keep them abreast of the progress in the frontier areas of science and technology.  Presently, the school consists of 92 faculty members. The department has continuously been responding to scientific challenges by launching research initiatives in strategic thrust areas such as pharmaceutical technology, medical nanotechnology, drug design and Indian systems of medicine. “We motivate students to take up research” —Dr S Swaminathan, director, Center for Nanotechnology & Advanced Biomaterials, and dean, Sponsored Research, Sastra University “What are some of the achievements of the institute in recent years? Sastra has been re-accredited by National Assessment and Accreditation Council with A grade. The School of Chemical and Biotechnology was ranked as the No.1 private biotech school in the country in 2007. The postgraduate program in medical nanotechnology is fully-funded by the Nano Mission Council, Department of Science and Technology (DST), Government of India.  DST has also recognized Sastra as a scientific and industrial research organization. We have created two autonomous centers–Center for Advanced Research in Indian Systems of Medicine (CARISM) and the Center for Nanotechnology and Advanced Biomaterials (CeNTAB).   Further, we have been selected by CSIR as a center for open source drug discovery. Sastra is one of the host institutions in the Research Internship in Science and Engineering (RISE) program of the Indo-US Science and Technology Forum. Sastra is also a member of the BME Planet, which is a global network for bioengineering. BME Planet has been established by the University of Virginia through the funding from National Science Foundation (NSF) and other foundations. What are some of the unique features of the biotech department? The School of Chemical and Biotechnology at Sastra possesses well-equipped laboratories supplemented by highly impressive infrastructure, excellent ambience for research and scientific activities, qualified and dedicated faculty team with a strong focus on research in diverse areas like other departments at Sastra. The school also has access to a GLP compliant animal facility and most of the sophisticated instruments and equipment within the campus.  The presence of two major autonomous centers (CARISM and CeNTAB) of the school provides a variety of opportunity to both students and faculties.  The school also offers certificate programs in allied areas based on students’ interest to further broaden their horizon and sharpen their skills. We also provide students, even at the undergraduate level, opportunities to work on research project.  What are the new modules you have added to align your education with industry needs? Sastra emphasizes on the removal of obsolescence and in introducing state–of–the–art technologies. The freedom and flexibility to modify the curriculum has been a great advantage to the students and faculties of the school.  To keep pace with industrial research, we have introduced courses on medicinal chemistry, recombinant DNA technology, signaling pathway analysis, nanostructuring, drug delivery systems, tissue engineering, smart nanoparticles and biomedical nanotechnology to prepare the students for a career in industrial research.  What are some of the research projects that students or faculties have initiated? There is active research in the areas of tissue engineering, drug delivery, electrophysiology, chromatin remodeling, scientific validation of Indian systems for  medicinal purposes, nanosensors, nanofluids and development of mesoporous materials.  We work on developing scaffolds for regeneration of the skin, small diameter cardiovascular grafts, nerve, bone, etc.  We have also synthesized materials that could be used for targeted delivery of anti-cancer and antiretroviral drugs. Jahanara Parveen ]]> <![CDATA[Budget 2009 fails to pep-up biotech]]> https://biospectrumindia.com/news/95/6185/budget-2009-fails-to-pep-up-biotech.html https://biospectrumindia.com/news/95/6185/budget-2009-fails-to-pep-up-biotech.html Wed, 05 Aug 2009 13:12:00 +0530 Budget 2009 fails to pep-up biotech It does not take into account the critical comment from the Economic Survey which states that: drugs price control should be limited to essential drugs in which there are less than five producers. Pranab Mukherjee Despite major boosters like the removal of surcharge on personal income tax, enhanced group specific exemptions and abolition of the fringe benefit tax (FBT), Budget â€“ 2009, gives lukewarm benefits to all, and fails to make any impression especially among the business sector including the pharmaceutical industry. It hasn't taken into account a critical comment from the Economic Survey which said that the 'drugs price control should be limited to essential drugs in which there are less than five producers. All other should have been decontrolled'. Compared to the Economic Survey's annual Rs 25,000 crore, the revenue generating target of Rs 1,120 crore this fiscal is a pittance, say experts. The UPA-II's first budget presented before the House on July 6, by finance minister Pranab Mukherjee, couldn't sweep the business sector at large, thus giving very little scope to enhance the development of the country, and provide an optimistic inspiration to India's economic future. Like other markets, pharma and biotech industry too look disappointed with no major announcements to pep-up the existing scenario. For instance, the market for two life-saving drugs and other nine specified drugs used for the treatment of cancer, Hepatitis-B and arthritis is marginal and doesn't have much impact on the industry; shows Pranab da's budget still has miles to go. Coupled with mixed reactions, the czars of the Indian biotech industry share their happiness as well as disappointment on the budget and its repercussion in the ensuing financial year. BioSpectrum takes a first person account of the Union Budget 2009 Sanjeev Saxena, chairman & CEO, Actis Biologics, Mumbai, said, â€œThis year's budget is more for the common man than for the corporate world. Incentives proposed should have some impact on the investments and hence, may refuel the growth of economy. Abolishing the FBT is welcome, as corporate India should be ready to start taking more trips and hence this should refuel the aviation industry with the result the transport industry will also see a change.â€? To Saxena, the problem with this budget is that no incentives have been provided for R&D or the pharma and biotech sector. â€œI would have been happier had he (FM) put in incentives which would have been allocated for new technology development or new drug development. Also, direct investments into the biotech would have been highly desirableâ€?. Dr GSK Velu, managing director, Trivitron Group, said, â€œIn the budget there is nothing substantial for healthcare sector. For medical devices segment, we were asking the same benefit which has been offered to other even non-critical segments like mobile phones in which raw materials and components imported for ultimate manufacturing in India should be allowed duty free import. To our surprise, even this year, this was not announced. All attempts has been in the direction of encouraging imports and disincentivising local manufacturing initiatives. We are most disappointed with this. Even for healthcare sector, infrastructure status has not been granted which has been a long term demand from the healthcare Industry.â€? â€œOverall, it's a disappointing budget for healthcare services and medical devices segment,â€? Velu quips. This year's budget failed to provide the much-sought impetus to the pharmaceutical industry, feels Supratim Majumdar, industry analyst, Healthcare Practice, South Asia and Midldle East, Frost & Sullivan. â€œWhen R&D and innovation are the buzzwords in the industry, and the R&D spending as a proportion of revenue is continuously increasing year-on-year, the finance Bill remained silent on incentives for R&D investment,â€? he said. Pointing out on the increased allocation for National Rural Health Mission over and above the outlay in interim budget will expand the access of healthcare facility, Majumdar said, â€œThis consumption-oriented budget if implemented means more money in the hands of people, and that's going to increase private healthcare expenditure which include expenses for medicines. That can be a boost for the pharma industry.â€? He told that reduction of customs duty for 10 specified drugs and two life-saving heart devices from 10 to 5 percent and 7.5 to 5 percent respectively, along with total exemption from excise duty and countervailing duty will make the medicines more affordable for patients. These include influenza vaccine and nine other specified drugs used for treating breast cancer, Hepatitis-B and rheumatic arthritis. But there's something for the industry to cheer up. Pharma exporters hurt by the global economic turmoil are going to benefit from the one-year extension of the Export Credit Guarantee Scheme till March 2010; the decision to reduce customs duty on life-saving drugs as well as some of the vaccine and cancer treatment products have lightened the heart of the pharma industry. If tax reduction is giving the benefit of cost effective treatment to patients, then cut in customs duty on medical equipment specially heart devices will benefit the healthcare sector. As Sanjay Nagrath, vice-president (finance), Intas Biopharmaceuticals, said, â€œWe welcome the exemption of Advanced Tax payment on small businesses, who are allowed to pay their entire tax liability at the time of filing returns. Abolition of FBT and Commodity Transaction Tax is good move for companies. Raising exemption limit of Rs 10,000 in personal income tax is hardly any relief given to individuals. Government has done well in allocating resources for welfare schemes and targeting creation of 12 million jobs, which is a welcome move in times of recession. Induction of Service Tax in the field of Law, in case same is provided by Law firms to corporate, is a negative move. Service tax paid to foreign agents toward commission under reverse charge is discontinued. This is a positive move for corporate houses. Scope of provisions relating to weighted deduction of 150 percent on expenditure incurred on in-house R&D to all manufacturing businesses being extended is a welcome step. Legitimate R&D expenses, including filing patents to protect IP, which, in our view, would need to be covered under the weighted deduction scheme.â€? Congratulating the FM for identifying health and rural infrastructure as focus areas in the Union Budget, Gautam Khanna, vice-president, 3M India Health Care Business, said, â€œBy significantly augmenting both the National Rural Health Mission and the Rashtriya Swasthya Bima Yojana, the budget has ensured greater access to primary healthcare services. By increasing the Gross Budgetary Support with a special emphasis on rural infrastructure and the 27 percent increase for the rural electrification program, the primary healthcare sector will greatly benefit and ultimately impact the common man. Healthcare delivery systems will improve with further investments in infrastructure development. We welcome the Finance Minister's proposal to exempt the medical equipment sector from the increase in central excise duties.â€? Teruo Yasufuku, MD, Astellas Pharma, said, â€œThe budget is positive especially for overall development of the rural healthcare. An increased allocation of Rs 2,057 crore over and above Rs 12,070 crore to the National Rural Health Mission will have a positive impact on the national healthcare.â€? However, emphasizing on the much needed awareness regarding organ transplant which is yet to make a significant dent in India, Yasufuku says that the budget should have also focused on providing better infrastructure and raising awareness concerning organ transplant in the country. Upbeat about the finance ministry's focus on the improvement of healthcare infrastructure by increasing allocation under National Rural Health Mission Tapan Ray, director general, Organisation of Pharmaceutical Producers of India (OPPI), told BioSpectrum that the budget proposal covering all BPL families under Rashtriya Swasthya Bima Yojana (RSBY) with an increase in allocation by 40 percent, will help in improving healthcare access. Likewise, K Chandran, director, Wanbury, too is of the opinion that National Rural Health Mission (NRHM) funding and rural insurance will benefit the rural population, which comprises over 70 percent of the total population of the country (approx. 1.15 billion). Chandran said that 9 percent GDP growth target is good. But his concern was the 'how' factor which is missing in the budget. But Indranil Das, vice-president- finance and accounts, Biocon, is neither happy nor sad about the budget. â€œOverall, the budget does not have any negative impact on the pharma industry per se, however, by not amending most provisions it does not provide any fresh incentives either. So I would say pharma industry has been budget neutral,â€? he said with a smile. However, experts in the pharma industry feel that had the government announced a total excise exemption on 354 drugs specified in the national list of essential medicines, then it would have made a strong impact on the industry. The industry was carrying a lot of expectations from this budget which did not come out well in terms of infrastructure development, fiscal deficit and disinvestment programme. But hope never dies. In spite of some degree of disappointment with the Union Budget-2009, the pharma and biotech industries are holding on to what Martin Luther King, Jr, once said, â€œWe must accept finite disappointment but never lose infinite hopeâ€?. Anjana Pradhan (with inputs from Nayantara Som, Shalini Gupta & Jaharara Parveen) ]]> <![CDATA[Serum leads India's Swine Flu Vaccine Race]]> https://biospectrumindia.com/news/95/2348/serum-leads-indias-swine-flu-vaccine-race.html https://biospectrumindia.com/news/95/2348/serum-leads-indias-swine-flu-vaccine-race.html Wed, 05 Aug 2009 13:11:00 +0530 Serum leads India’s Swine Flu Vaccine Race India’s largest biotech company and also one of the world’s top pediatric vaccine makers, Serum Institute of India, based in Pune, is lead player from the country in the global race to  develop an effective vaccine against the  “unstoppable” spread of the swine flu virus. Two other companies—Panacea Biotec and Bharat Biotech— too have joined the race. A Special Report. It is a quiet corner of the sprawling campus of  Serum Institute of India in the western Indian city of Pune, a crack team of 16 scientists has been running a battle against time. This team, chosen specifically by the senior management of India’s largest biotechnology company, has no time to relax, as they are part of the global race to develop a vaccine against the swine flu. The crack team now works out of BioSafety Level 2 (BSL 2) facility, enhanced with various facilities as per current global standards. The facility suitable for work involving agents of moderate potential hazard to personnel and the environment. It includes various bacteria and viruses that cause only mild disease to humans, or are difficult to contract via aerosol in a lab setting, such as Hepatitis  A, B, and C, influenza A, Salmonella, mumps, etc. The team was put together just a few weeks after the first Influenza A infection, caused by a new, virulent strain H1N1 was first detected on April 12, in a small village near Veracruz in Mexico. It was transmitted from pigs to a five-year-old son of a worker in a pig farm. And it was quickly named, the “swine flu” virus. The summer in the Northern Hemisphere is the time when influenza viruses normally lie low, waiting for their turn to strike as the winter set in around October-November. However, this H1N1 strain has had other ideas and aided by air travel, it has traveled to the farthest corners of the world within weeks. And the global health agency, the World Health Organization (WHO) of the United Nation has now termed it “unstoppable.” Normally, it takes about 25 weeks for a new influenza virus to cover the planet. But H1N1 reached all continents within nine weeks and WHO was forced to term it a pandemic, the term used to describe a viral infection present widely in all the continents on Earth. And it triggered a global  response to find a solution to secure people in the years to come in the shortest possible time. “The flu transmission didn’t stop even after the increase in summer temperatures. And studies have indicated that people born after 1975 were more vulnerable due to the inability of their immune system to recognize this H1N1 virus strain,” said Dr Suresh S Jadhav, executive director, Serum Institute, and coordinator of the company’s swine flu vaccine initiative. WHO has decided to take the H1N1 challenge head on and hence roped in as many companies as possible with expertise in manufacturing vaccines to develop a vaccine against the H1N1 influenza strain. Though Serum Institute is not a manufacturer of seasonal influenza vaccine, Serum was chosen from India by WHO to lead the challenge. Technical and other inputs to Serum followed. WHO has roped in 21 current manufacturers of influenza, located mainly in the US, Europe, Japan and Australia for the global efforts. Serum Institute and five other companies—Birmax, Mexico, Bio Farm ( Indonesia), Government Pharmaceutical Organization (GPO), Thailand,  Vabiotech ( Vietnam) and  Butantan, Brazil—were chosen by WHO to join the global swine flu vaccine production efforts. Gearing Up Developing a vaccine against the H1N1 virus strain is complex and time-consuming process. Serum Institute’s team is very much aware of the complex process, informed Dr Rajeev M Dhere, senior director, handling the effort at the Pune company.  Influenza viruses change frequently and usually a vaccine made against a specific strain is useful only for vaccination during single season. So each year the seasonal influenza vaccine is changed. The seasonal vaccine production for the influenza viruses which were expected to activate in the winter of 2009 is almost fully ready and stocked up in major consumption areas of the world. Experts indicated that the current year’s seasonal influenza vaccine has used three virus strains: A/Brisbane/59/2007 ( H1N1), A/ Uruguay/716/2007 ( H3N2) and B/Florida/4/2006. Dr Dhere said experts at the Centers of Disease Control (CDC) in the US have determined the genetic sequence of the new H1N1 influenza virus. The genetic sequence is significantly different to the H1N1 contained in the current seasonal influenza vaccine. So the current seasonal vaccines will not provide any protection against the new H1N1 strain and hence a different vaccine is required. Several strains of the H1N1 viruses have been extracted from the infected people in Mexico and California. The A/Mexico and A/California strains are the basis for the vaccine production. Dr Dhere explained the process. The first step in the vaccine production is the making of the “seed” virus. Experts at CDC have prepared the “seed” virus from A/Mexico and A/California H1N1 strains.  The “seed” virus is a safe form of the influenza virus, stripped of its parts that spread the infection. The live virus is genetically altered to make it safe.  This is a time consuming process and takes about three to  four weeks. This “seed” virus is supplied to vaccine manufacturers chosen by the WHO around the world. The “seed” viruses from various strains are then prepared to be ready for vaccine production by a process called “assortment.”  These reassorted viruses are then injected into specially prepared pathogen-free, fertile chicken eggs. The safe virus then grows inside the eggs for four to six weeks. The viruses are then extracted from the eggs, purified and inactivated and then formulated into a vaccine. Serum Institute has got the “seed” viruses. During this period, H1N1 strains have been extracted from infected patients in India and Turkey too. And the viruses are identical indicating that the new vaccine should work against the swine flu which has spread to all these regions effectively. The normal dosage of influenza vaccine is 15 mg. From each chicken egg, one dose of influenza vaccine is produced. Sometimes, two eggs may be required to produce each dose of standard influenza vaccine. Tricky Part Serum’s team is now confronted with  another tricky part of the project. That is to source enough chicken eggs to grow the vaccine. Luckily, Venkateshswara Hatcheries, India’s largest poultry maker is situated in the same city. “Currently,  the company will supply us about 100,000 pathogen-free eggs. But if there is urgent requirement to step up the vaccine production, they will be able to give us up to 2.5 million eggs a month,” says  Suresh Jadhav.  There are two other major poultry suppliers near Bangalore. They too will be roped in if the swine flu virus spins out of control in the country. But so far things have been under control with less than 500 H1N1 infections reported in India till July-end. Under the scheme supported by WHO, Serum Institute is committed to provide at least 10 percent of its swine flu production for use in other countries. “Such an assurance has been guaranteed by the Indian government. This is just to ensure that in the case of a national emergency, the government does not stake claim to the entire production leaving nothing for global use,” explains Serum Institute’s senior director, Dr Satish Ravetkar. Though the Indian government has given the go ahead for mass scale production of the H1N1 influenza vaccine, it has yet to give firm orders to either Serum Institute or the two other India companies—Panacea Biotec, New Delhi, and Bharat Biotech, Hyderabad—about the quantity requirements. “We have given  approvals to these three companies (Serum Institute, Panacea Biotec and Bharat Biotech)  to get seed strains from CDC, Atlanta and the UK-based National Institute for Biological Standards and Control (NIBSC) to start preliminary research,” said  Drug Controller  General of India (DCGI), Dr Surinder Singh. The companies will now have to go through the other stages of development like pre-clinical trials and clinical tests. Scientists at Serum expect to have the vaccine ready by September. They are also preparing a limited human trial involving at least 25 volunteers. It will be another six months before the vaccine will be ready for mass use. In the event of an emergency, WHO has clarified that countries could relax some of the stringent provision related to approvals to speed up the vaccine’s availability to fight a raging swine flu pandemic. Authorities in China have been more proactive and the Beijing city government  has already placed the order to supply at least 4 million doses by the end of September to local vaccine maker, Sinovac. This order will be administered to 2 million people in the high risk group. Additional orders are expected beginning in October and, in total, Sinovac expects to supply approximately 10 million doses to the Beijing government. The 10 million doses will be administered to five million people in Beijing. Serum plans to invest over $30 million (Rs 150 crore) to set up a separate facility to make the swine flu vaccine. “This is part of our commitment to make available affordable vaccine to the people who will need it the most,” asserted Serum’s chairman, Dr Cyrus S Poonawalla. He will be happy if the Indian government makes a firm announcement about its plans to tackle the swine flu which is likely to be around for some more years to come. India’s citizens are waiting for a similar announcement from their government. Of course, the government is not concerned too much because of the mild form of infection that has surfaced in the country so far. Yet again, the beneficiaries of the technological prowess demonstrated by a company like Serum in developing an influenza vaccine in the shortest possible time could be many global citizens.  Narayanan Suresh in Pune ]]> <![CDATA[Anthem Biosciences on high pace growth]]> https://biospectrumindia.com/news/95/2164/anthem-biosciences-on-high-pace-growth.html https://biospectrumindia.com/news/95/2164/anthem-biosciences-on-high-pace-growth.html Wed, 05 Aug 2009 13:02:00 +0530 Anthem Biosciences on high pace growth With the right business model and a planned strategy, Anthem Biosciences is well positioned to benefit from the opportunities available in the contract research space. Having strong project pipeline from large multinational pharmaceutical majors, the  start up is all set to cross Rs 65 crore in the current financial year. Some businesses start with years of planning and some are just meant to happen. In this current marketplace, most new businesses start as a result of years of market research and business planning. Venture capitalists, founder(s) and consultants get together with ideas, and they work on the process in order to maximize profits. Despite this, while most of them take several years to reach their growth capacity and churn out significant revenue,  there are some marked examples of businesses that started out organically as an idea of one/several individuals. Started in the year 2006, Bangalore-based Anthem Biosciences is an  example of an idea and an opportunity getting executed and exploited. The founders did not spend too much time discussing it. They started with the right planning and in short time the company was up and running. The genesis After working for over two decades, and having pioneered in setting up new businesses in their previous jobs, the founders of  Anthem had reached a point where the next level of growth for them had to be outside their former employer. It is a natural evolutionary process, for some to set up something on their own. There are always ideas that one has when working in a job, which never get taken up due to various factors and just fade away. Most of them never have the opportunity to try them out and see if there is really some substance in them. They had such an opportunity, they took it, and Anthem was set up. People behind Anthem come with diverse background. Anthem Biosciences toppers are Ganesh Sambasivam, K C Ravindra and Ajay Bharadwaj. Its other business Anthem Cellutions, which mainly deals in enzymes, nutraceuticals and food additives, was founded by Malay Barua, Rupesh Kinekar and Ajay Bharadwaj. The people at Anthem Biosciences bring years of  experience to the company. It is a team of experienced chemists, biologists, engineers and businessmen. “Ganesh was the Chief Scientific Officer of Syngene, a Biocon group company and Ravindra was heading manufacturing at Biocon. So there is a lot of complementarity of skills. Three of us bring research, manufacturing and business experience with the company. In Cellutions, Rupesh was handling Business Development at  AB Mauri, he had worked in Biocon before and Malay Barua was heading the enzymes business in Biocon. We know each other from a very long time, says Ajay Bharadwaj, CEO and co-founder Anthem Biosciences. “We never talked about it at Biocon. I was in Biocon for a very long time, more than 21 years. I was a part of the very initial group. So, I was the President, Business Development at Biocon and any growth further beyond that had to be lateral it wouldn’t be vertical within Biocon. The next position I could grow to was not open. So I had to go out of the company. I must also emphasize that I have a very good relation with Kiran and Biocon,” adds Bharadwaj. Anthem Biosciences started  in July 2006 and within three months formed the enzymes business division. They are two distinct businesses, but part of the Anthem family. Commenting on the idea of setting up of Cellutions, Malay Barua, Head, Anthems Cellutions says, “Novozymes acquisition opened our eyes to a very good opportunity. We had good knowledge and affinity for this business. Our passion for enzyme business actually led to this move. Novozymes is number one player in the enzyme space so we thought why not create the number two. And with decades of experience in this segment we thought that we can start.” Raising operational funds wasn’t difficult. The founders convinced State Bank of India to lend them money. However as most budding businessmen do, Anthem owners did not approach venture capitalists, although the company did talk to to a lot of VCs. “The decision turned to be good because the economic downturn had made the VCs very restless, so getting them on board would have created a lot of tension,”  Bharadwaj says. Company Offerings Anthem Biosciences, is a DRAP (Discovery Research Alliance Partner) for its clients. The founders hate to call Anthem an “outsourcing company” and instead refer to it as  “research support and services.” The company offers value added services at any stage of the drug discovery process, including integrated early stage development of a drug from concept to proof of concept. Dr Ganesh, CSO and co-founder, Anthem Biosciences says, “We have expanded the research support business beyond just a pair of hands, by offering significant intellectual contribution to the projects entrusted to us. The services include early stage chemistry, building blocks, medicinal chemistry (hit to lead to lead optimization), route scouting and process optimization, in vitro and in vivo biology, GMP and non GMP kilo and pilot plant. We have a number of integrated development projects for small biotechs as well.” In a span of three years, the company has built competitive teams to undertake entire discovery projects in different therapeutic areas such as oncology, anti-infectives, cardiovascular, inflammation, metabolic disorder.. Anthem provides analytical support for discovery services, chemical development and manufacturing. Its control team is capable of developing robust analytical methods for various services. Anthem Cellutions has contributed 25-30 percent of the total revenue in 2008-09 to the group. Anthem has some very good plans for Cellutions but does not want to reveal it now. Barua however shares, “We will be looking into adding more portfolios in this business. Right now we are formulating niche products using our expertise.” He further says, “We don’t do any manufacturing, we are a research and services company. We don’t have the typical CRAMS model.” Growth targets & strategy Anthem has achieved a revenue of Rs 45 crore for its first full year of operation. The company hopes to cross the target of Rs 65 crore for the current financial year. According to the founders, so far the company is on track.  Its focus is delivery centric and not just scale and customer acquisition. The company is continuously adding new dimensions and capabilities to its portfolio, which keep pushing the envelope in this whole research support services space. Bharadwaj comments, “We had a good start. That is not always easy. Our strategy would be to keep it sustained. So our focus will be to build on this good start and also establish platform technologies to set us apart. We will also be looking at hiring quality people. We have more than 200 people now, 170 of them being scientists with good years of experience in the pharmaceutical industry.” “The company has very clear plans of using the internal funds for financing further growth. Currently, the focus is to grow through internal accruals and debt. Our banks are very supportive and internal generation of cash is enough to allow us to fund the next growth cycle, adds Bharadwaj. Investments and future plans The overall investments in Anthem have been to the tune of Rs 40 crore. “Having worked in this domain for years we are very sure about what we are going to do, what the infrastructure is to be put in, what will be our area of expertise and we did exactly that. We are spot on budget, not a rupee less or more, says Bharadwaj. Anthem has significantly invested in new biology infrastructure and is now adding some platform technologies, which will further set Anthem Biosciences apart from its peers. For its enzyme business the company is planning significant investments to cement its position as a biology led enterprise. “We are putting new platform technologies so we are building bigger and better labs. We are putting up a new building. One of our big focus is also doing integrated development projects—starting with target given by the clients to convert them into optimized leads and do the in vivo and in vitro testing.  The more we add in terms of infrastructure the more our clients will give us integrated projects,” shares Sambasivam. The management in Anthem do not believe in spending too much time and energy in client acquisition. They say, “Once having done that the real focus of delivery gets disillusioned. We are over 96 percent successful in our projects. Our business model was that we need not be the biggest company but we certainly want to be the best.” Anthem is flexible in its approach to evolve efficient models that suit each client. Thus in this crowding segment of CROs, Anthem has successfully distinguished itself as a top tier organization with a highly skilled team, quality services and on-time performance. Anthem is located in an industrial park in Bangalore covering five plus acres with a built capacity for  more than 250 researchers. Currently, the company employs over 200 people and plans to hire more.  The CRO started with debt financing from State Bank India. The equity investors are Dr Ganesh Sambasivam, K C Ravindra and Ajay Bharadwaj. The company also has a small equity investment from its marketing alliance partner in the US, Davos Pharma. Jahanara Parveen ]]> <![CDATA[Biotechnology education in India: concerns and challenges]]> https://biospectrumindia.com/news/95/5492/biotechnology-education-in-india-concerns-and-challenges.html https://biospectrumindia.com/news/95/5492/biotechnology-education-in-india-concerns-and-challenges.html Wed, 05 Aug 2009 12:29:00 +0530 Biotechnology education in India: concerns and challenges Biotech sector is knowledge intensive and requires highly skilled manpower. There is an urgent need to attract bright students to create and sustain a world-class human capital in biotechnology. Dr Suman Govil and  Shubhlata Sharma Department of Biotechnology, Ministry of Science and Technology, New Delhi Biotechnology has  tremendous  potential  in  improving human and animal health, increasing agricultural productivity and providing safe and clean environment. Realizing the urgent need to create high quality workforce, the department of biotechnology initiated an integrated program for human resource development comprising of post-graduate teaching, doctoral and post-doctoral fellowships, training of post-graduate students in industry as well as re-training of existing faculty and scientists in leading national and overseas laboratories. The department took a conscious decision not to start undergraduate teaching in biotechnology as it is  highly specialized and laboratory intensive course. It is difficult to attract faculty with relevant expertise in undergraduate colleges due to lack of research environment and proper laboratory facilities for hands-on training. It is difficult to provide fundamentals of basic science in specialized courses at undergraduate level and future career options available to students are also limited. The same sentiment has been recently echoed by Top-3 science academies of the country requesting HRD minister to wind-up all specialization courses currently offered at the school and undergraduate level. DBT initiated  MSc courses  in biotechnology in 1985  in six universities in  consultation  with other educational and research ministries. This was first such attempt in the country which was greatly welcomed by academia and industry alike. These programs were conceived as collaborative, inter-departmental  and inter-institutional programs and initiated  on  the basis of  core strength of faculty, existing infrastructural facilities, R&D grants received on  competitive funding basis,  nearby  institutions engaged in biotechnology R&D. Initiation of these teaching programs in biotechnology improved quality teaching in biotechnology as well as allied life science fields due to improvement of laboratory infrastructure and bringing in new expertise. However, setting up of separate biotech departments subsequently by universities at times, alienated other participating departments. Perhaps, setting up of a school comprising of different departments could have been a better alternative.  The department provided liberal grants for establishment of specialized laboratory infrastructure, recurring grants for consumables, studentship, books and journals,  travelling, visiting faculty and contingency. Keeping in  mind, the demand for trained manpower in specific areas  and regional  aspirations,  these programs  have been expanded in  over 70 universities in general and specialized courses in biotechnology.  Simultaneous uncontrolled expansion of  courses by various private and public sector institutions without proper assessment of manpower requirement,  available laboratory infrastructure, experienced faculty and sufficient consumable grant, has severely affected the quality of training imparted and damaged credibility of biotech courses in general.  Although there are no authentic estimates of the number of institutes conferring biotechnology education, there are varying reports. According to a report in The Hindu in 2004, 104 colleges (36 in Tamil Nadu alone) offer biotechnology at BE/BTech level. Survey conducted by IIM, Bangalore, in 2007 reports an output of 10,000 students per year at UG, PG and doctoral levels from 250 colleges with predicted annual growth rate of 20 percent. Education and Career Resource Guide brought out by BioSpectrum in 2009 lists 49 BTech courses, 108 PG (MSc/MTech/MPhil), 50 PG/PhD, 140 BPharm/MPharm courses. Geographical analysis of these institutes shows  that  Tamil Nadu tops the list with largest number of educational institutions offering biotech courses, followed by Karnataka , Maharashtra, Andhra Pradesh, UP, Delhi and Kerala.   Quality of students passing out of universities depends on a number of factors viz., selection of bright students with right aptitude, committed faculty with relevant expertise, upgradation of faculty, creation of laboratory infrastructure, updated curricula and enough hands-on training.  Selection of students for DBT supported programs is made through common entrance test conducted by JNU at over 70 centers all over the country and only one out of 70 applicants is selected. Selection is based on multiple choice-based questions due to difficulties in evaluation of subjective question papers for logistic reasons. However, commercial interests of institutions running courses in self-financing mode leads to admission of second rated students. As against the number of students restricted to 10-15 per year in DBT supported programs, some of the universities admit as many as 150 students further affecting quality of practical training imparted. Some of the decisions to admit huge number of candidates appear to be guided by commercial reasons as these institutes charge substantial sums of money to the tune of Rs 1-2 lakh per annum.  In the DBT supported teaching programs, emphasis has been laid to appointment of 4-6 core faculty positions with relevant qualifications and expertise as well as provision for inviting visiting faculty in gap areas. Enough attention is also paid to upgradation of skills of faculty by organizing training in leading national and international laboratories. Appointment of contractual faculty with low remuneration without proper educational background and experience by universities running courses in self financing mode is a major constraint in conferring quality education. Some of these  programs are run with skeletal faculty who cannot be spared for faculty improvement programs further affecting the quality of teaching. The department of biotechnology  ensures that model course curricula are developed periodically through a consultative process to maintain uniformity and to lay emphasis on practical training. New courses on intellectual property rights, regulatory issues,  communication skills and recent developments have been introduced to address the concerns of industry. Some of the universities continue to teach outdated curricula due to lack of expertise and facilities. The department is providing consumable grant and thesis grant on per student basis to ensure good practical training and has made it mandatory to conduct in-house project work. Some of the institutes conduct practicals in groups of 4-6 students and a large number of practicals are only demonstrated which severely affects their employability. Dr Lakhotia has addressed and condemned the decision of universities to compel students to take up project work in other institutes.  This mandatory requirement of project work has led to mushrooming of private training institutes putting double financial burden on helpless students. Opportunities for biotechnology students exist in  agri-based industries,  pharma industries, clinical research organizations,  bioinformatics industry in R&D,  production and manufacturing,  quality control and analysis (QA/QC), technology transfer and management,  knowledge-based marketing, consultancy organizations for preparation of  techno-economic feasibility reports, regulatory affairs, patent attorneys and examiners.  The CEOs and HR executives of biotech companies interviewed by IIM, Bangalore revealed that employability of biotech students varies from 25-50 percent. IIM, Bangalore survey clearly brings out that intended supply of manpower is higher than the incremental demand for manpower per year. The problem is further aggravated by gap in demand and supply, employability of manpower and mismatch in availability of jobs and preference of students. Attention should be focused on quality education.  Although jobs for  marketing  are 20 times  more in number as well as monetarily rewarding, biotech students opt for marketing as their last choice. An analysis of job preference by industrial trainees by Auroprobe Laboratories shows 58 students opted for R&D as first preference, 22 opted for quality control and analysis and only 14 opted for operations. All students opted for marketing as last choice. This does not augur well as there is a mismatch between job availability and preference of students.  Analysis of first placement of MSc students passing out of DBT supported programs shows 50 percent students opt for higher studies in India and 15 percent opt for PhD in overseas laboratories. Only 15-20 percent MSc students and 45-50 percent MTech students opt for jobs in industry. One possible reason for few students opting for jobs in industry could be low remuneration, non fulfillment of high expectations, routine jobs and stagnation in career graph. To attract students for taking up jobs in industry and to bridge the skill gaps, the department is providing industrial exposure to biotech postgraduate students for period of six months in industry. Biotech sector is knowledge intensive and requires highly skilled manpower. There is an urgent need to attract bright students, provide quality training, retain talent, retrain existing people and reverse brain drain by providing  re-entry packages  to create and sustain a world-class human capital in biotechnology. Holistic education with judicious balance of basic fundamentals as well as latest developments need to be imparted. Undue rush to introduce biotechnology courses without proper infrastructure, expertise and research environment needs to be curbed. Efforts should be made to make education relevant to the needs of biotech industry. The industry should review  remuneration packages offered to fresh entrants like the revision of fellowships by various government agencies.  ]]> <![CDATA[Get international talent]]> https://biospectrumindia.com/news/95/1367/get-international-talent.html https://biospectrumindia.com/news/95/1367/get-international-talent.html Wed, 05 Aug 2009 12:23:00 +0530 Get international talent Attracting international talent is a useful proposition. India is still facing shortage of highly motivated scientists with global outlook. There is a huge demand of skilled manpower in research, biomanufacturing and services. Companies in the bioscience industry have woken up to the reality and have realized that a definite strategy is required to attract international talent to fill in the talent gap that is persisting in the industry. This also means attracting expatriate talent, if the region is to keep up the pace with the leading clusters and companies in the global life science industry. The recognition of India as an emerging bioscience destination have inspired many NRIs to return to India, thereby offering the country benefits of a reverse brain drain. As a large number of multinational companies and organizations find the global Indians an attractive scientific pool, therefore, the return of NRIs from the west is proving immensely fruitful as they are finding multiple avenues in India to explore in terms of job and career. So the latest question doing the rounds—Is international worth the game? Industry experts say, “Yes, why not.”  “The world is becoming flat and a global village. Indian students studying abroad have a different management style and wider perspective of the industry,” elaborates Dr Bhuwnesh Agarwal, chairman and MD, Roche Diagnostics India. Interestingly, most of the Indian multinationals are seriously considering attracting international talents.  Many Indian biotech companies are now repositioning their international talent initiative to attract skilled international manpower. Industry believes that internationalization at workplace creates a feel of different cultures, languages, diverse outlook and understanding. Therefore, the Indian biotech companies are hiring NRIs and foreigners who wish to work in India, and offering them comfort in the local environment. Some of the life science companies which are actively hiring NRIs and foreign nationals are Biocon, Avesthagen, Dr. Reddy’s Laboratories, Ranbaxy and Sami Labs. Suresh Vazirani, MD of Transasia said, “It would be worthwhile to recruit international students for functions like R&D, quality systems and automation.  This would mean exchange of ideas and new perspectives regardless of national boundaries. Having international talent would mean boosting up efforts for indigenous innovation and continuous improvement in related sphere of business activities. Same impact would be on reduction in lead time for delivery and possibly enhancing product life cycle.” He recommends that short-term assignments as consultants with proper compensation should help to attract international talent. Attracting international talent is a useful proposition for Indian companies as foreign universities provide good educational inputs and are considered to be better aligned with industry requirements. “This can be effectively worked out in companies through exchange programs between domestic universities and foreign counterparts,” said Dr Kashmira Pagdiwalla, director (HR operations), Intas Biopharmaceuticals. In an effort to attract more talent from abroad, CSIR too plans to attract NRIs to help the country transform into a global life sciences center by offering them housing, health-care allowances as well as other benefits including education for children and residence rights.  According to a plan issued by the Indian government, CSIR would be looking at hiring NRIs at some of the key scientific positions in the year ahead. “These key positions are open to NRI scientists and will allow internationally-based scientists to return to India and offer their services. The government also supports the idea of attracting foreign scientists setting up companies in India,” states Dr Samir Brahmachari, director general, CSIR. He believes that if India is to maintain the international talent within the region, we would also need to look out for their families as most of the NRIs these days have a foreign spouse. One way of solving this problem could be by hiring the spouse as well and offering the family a proper residentship. Therefore, a solution to the problem on a political level is needed. The argument While most of the CEOs and HR heads support the idea of bringing foreign talent to India towards filling the demand-supply gap, there are few others who have a different opinion. They argue that this is not an ideal solution, but creating and nourishing home-grown talent pool is a better strategy for long term growth. According to them, globalized talent is more important only for companies that do business overseas and not all companies will be able to employ an international talent due to lack of resources. Moreover, foreign employees generally see employment overseas as temporary undertakings, with the aim to return to their homeland  after a while. Thomas Putti, Head HR, Advinus Therapeutics and president, National Human Resource Life Science Forum (NHRLSF), believes it is important that international talent should be brought in—both as faculty in universities to improve the quality of  education in India in addition to getting them into industry. Bringing international talent into industry will only help as a short-term measure. Ultimately, long-term sustainability will be achieved only by developing our own talent and building up our people to face global challenges. Apart from attracting global talent in the academia, he recommends that the universities should also look at strategic tie-ups with reputed international universities to enhance the quality and relevance of the courses and bring in improved systems of learning and evaluation. Giving a balanced opinion, K V Subramaniam, president and CEO, Reliance Life Sciences, said, “The need of the hour is to strengthen the talent pool in India and equip them to deal with the rising challenges posed by a knowledge-driven economy by industries such as biotechnology.”  He suggests that international talent access can be resorted in specific areas where there are competency deficiencies such as biopharmaceutical manufacturing and licensing. The retainment issue Retaining skilled executives and managers seem to become more difficult each year in a global business marketplace. The bioscience organizations too are investing more time, energy and money in attracting and retaining talent than ever before. Therefore, with the idea of attracting international talent, the question of retainment also comes in. Suggesting ways of bringing back NRI talent back to India and retaining them, Ravi C Dasgupta, group vice-president, HR, Biocon, states, “Attracting and retaining international talent starts from defining talent. External branding and internal branding are two most important ways to attract them. If the company cannot provide similar challenging and fulfilling environment, talent moved in from international companies will get disillusioned.” Suresh Ramu, VP of Data Management, Quintiles India, agrees. He says, “Talent retaining and engagement in clinical research services is different from other industries. In the talent life-cycle, engaging the right person successfully and retaining is a tougher job than hiring the right talent. Though qualifications and experience matter, flexibility to learn on a continuous basis is what a company sees in when hiring international talent.” As the needs of biosciences industry are complex, the need for better adaptation strategies in HR, is required. Niranjan Reddy, executive committee member of NHRLSF states that with huge growth projections for this industry, HR departments are required to play a more strategic role towards gaining international or NRI talents. Jahanara Parveen (with inputs from Nayantara Som) ]]> <![CDATA[Is GenX Ready for Biotechnology?]]> https://biospectrumindia.com/news/95/1130/is-genx-ready-for-biotechnology.html https://biospectrumindia.com/news/95/1130/is-genx-ready-for-biotechnology.html Wed, 05 Aug 2009 12:15:00 +0530 So, what does the industry want from biotech colleges and universities? HR heads get candid Is GenX Ready for Biotechnology? The GenX is a difficult lot, claim most industry experts and HR heads. â€œApart from lack of expertise, students today have unrealistic expectations like high salary packages plus most of them do not have much stability. We make huge investments in terms of time and money in training these new joinees but they leave the company once they get a foothold in the industry,â€? says an industry expert. His views are echoed by many. Attrition in the life sciences industry at present stands at 25 percent and is expected to shoot up. Above all, HR heads are candid about the fact that biotech colleges and universities do not train students for a career in the corporate world of life sciences but merely feed them with theoretical knowledge. Students who do not wish to be named in reality agreed. Criteria For Selection Academic knowledge and intelligence in the specific field, is the obvious priority for most companies going in for campus placements. â€œWe check the background of the student in its entirety which includes not just academic performance in college but also his performance in school. Moreover, a student is tested not just on his scientific knowledge of the field but also on social skills like his aptitude, capabilities and attitude towards his work and colleagues,â€? said VT Gopinath, head of the HR department, Actis Biologics. The Mumbai-based company conducts a 'Capability-based Interview', wherein students are assessed according to their capabilities in terms of knowledge in their respective fields, their capability to handle a research project, their capability to adjust in a team and also on their interpersonal skills. â€œA student might be intelligent but he may be lagging behind in interpersonal skills. So we also look into these skills, discipline, whether he will be a responsible candidate, whether he can mingle with his colleagues as research involves mingling and sharing of knowledge with your team members,â€? adds Gopinath. Gujarat-based Intas Biopharmaceuticals, also goes the same route wherein apart from the basic knowledge, students should be clear in the theoretical concepts related to biotechnology. â€œUsually, we hire students who have completed BSc, MSc, MTech and MPharm from reputed universities. Based on personal interviews, written tests and soft skills, students are reviewed for selection. If there are some areas of concern, then we evaluate and attempt to address them through interaction, after which they may or may not be selected for the job,â€? informs Dr Kashmira Pagdiwalla, director (HR operations), Intas Biopharmaceuticals. Reliance Life Sciences (RLS) provides students with an opportunity to become a part of the organization on completion of the competency development programs conducted by Reliance Institute of Life Sciences, a not-for-profit institution. â€œThis is with the objective of training fresh graduates and post graduates in specific fields of science and technology in order to support the talent requirement of Reliance Life Sciences and the biotechnology industry at large,â€? said K V Subramaniam, president of RLS. During the time of admission, students have to go through rigorous screening process which comprises online test followed by interviews. These programs consist of three months of classroom training and nine months of hands-on-training. Dito with companies like Biocon and Imperial Life Sciences which houses similar institutes. Such companies mainly take in students from these in-house institutes (though for some departments they look out for candidates applying from other sources). Roche Diagnostics, which is a recent entry into the Indian market will be looking at universities for talent recruitment. â€œAt our global office, Roche does recruit students from universities but in India, we're looking at the number of biotech colleges mushrooming across the country. We'll be hiring candidates from these colleges soon. We are always on the look out for youngsters who are toppers but then, they are put through several rounds of interviews,â€? informs Dr Bhuwnesh Agarwal, chairman and managing director, Roche Diagnostics India. Are Industry Needs Being Met? The answer to this question is a yes and no. Says VT Gopinath, HR, Actis Biologics, â€œBiotechnology in India is in its nascent stage and many biotech colleges and universities yet do not have a grip of the industry. Founders of private-run institutes are mainly entrepreneurs who do not have much experience and background of biotechnology. Moreover, most of these institutes are run like business organizations rather than an academic institution. The sole motive it appears is to merely churn out profits and revenues.â€? Industry experts point out that several biotech colleges, do not give much emphasis on quality education and practical training. â€œA large number of universities and institutions have, over the last few years, introduced several programs in the biotechnology and pharmaceutical domains to meet the growing talent requirements of the pharma and biotech industry. However, the curriculum could do better on practical exposure,â€? said Subramaniam. Agrees Dr Agarwal, â€œI believe that biotech students in India are extremely intelligent, creative and hardworking. It's just that they need grooming in having hands-on experience in the latest and emerging technologies. Unlike foreign universities, education system in India is such that students are not encouraged to think freely, the syllabus is old and not updated.â€? In addition to this, the quality of research projects undertaken by biotech institutes need to be worked upon. â€œUniversities and colleges should focus on country's needs. At present, it's like malaria, dengue which is the focus of the industry,â€? says Gopinath adding â€œat the end of the day, the industry needs students who are well tuned to the present day market demands and dynamics, however, here we have a case of students taking up research projects which have no relevance to the present day market scenarioâ€?. â€œUniversities in India are not up-to date with global and market realities. Also, their assessment and education delivery processes standards are not in line with those of the West. Their syllabi need to be updated, revised and so also the assessment systems. New streams, like preclinical and clinical research, pharmacogenomics and other such emerging subjects need to be offered by these institutions. We need to start giving focus on the research part of the R& D so as to enable budding scientists to develop a research mindset,â€? says Thomas Putti, president, National HR Life Science Forum and Head, HR with Advinus Therapeutics. â€œTechnical curriculum surely prepares them to become domain experts but corporate knowhow in the form of professional coaching is missing from the course content, teaching formats in colleges and universities,â€? says Anshula Verma, staffing head, Agilent Technologies. Infrastructure is another major problem most educational institutes face. Says Putti,â€?Candidates today come with a mindset of 'what is in it for me' rather than what they can contribute to the organization. The demand-supply equation for talent and niche skills is exploited by candidates to a large extent, putting internal parity and equity in the organization under stress. â€œFrom the technology front, experts are dissatisfied with the quality of the students being churned out. In such a situation, companies have no other option but to recruit the 'best out of the mediocre' and then subsequently invest heavily in training.â€? Beckman Coulter India which has its base in Mumbai since the past two years, has zeroed in 2009 as the year for its high-end flow cytometry products wherein many product launches are in the pipeline for this year. However, this has its own share of challenges. Says Dr Chandrasekhar SP, MD, Beckman Coulter India, â€œFlow Cytometry is a technology which is taught in limited institutions. Even if is taught, very few people get hands-on experience to play around with this technology.â€? There are workshops conducted to educate and train people for flow cytometry but these workshops, industry stalwarts opine â€œhold no waterâ€?. The diagnostic industry for example, has failed to attract within its fold, a sizable amount of skilled manpower. â€œToday, any person can open up a laboratory. All you need is a diploma degree. There are no courses for the field and this is coupled with absence of any regulatory authority. It is but possible that the lab technician you commonly see, does not have any knowledge on the high-end lab equipments used in his own laboratory,â€? said an expert under the condition of anonymity. Due to the paucity of skilled manpower, an expert told BioSpectrum, that in some cases doctors dictate reports to the lab technicians! â€œUniversities and colleges are aligned to the needs of the industry to a great extent, but they need to give students exposure and insights of selling of diagnostic equipments,â€? said Anil Dhale, vice-president, Human Resources, Transasia Bio-Medicals Ltd. Moreover, the kind of training given to the students is basic, subsequently putting the pressure on companies to come up with elaborate training and competency programs conducted at regular intervals. The gestation period for a candidate to become productive is long. And there's also the risk of leaving the company due to the availability of several opportunities in the market. â€œStudents ultimately lack focus and have little knowledge of their field,â€? adds Gopinath. However, there's also a positive side to the picture. There are some who believe that there is no dearth of talent in the industry. A well-known Indian CRO who doesn't want to be named, had set up a training center last year only to shelve out plans and dissolve it this year. â€œWe realized that we do not need such an institute. If our recruits need training, we go ahead with in-house training activities,â€? claimed a top-level expert from the same company. Universities and institutes are now trying to get aligned to the needs of biotech companies. â€œWe have received a lot of enquiries from colleges for suggesting changes in course curriculum, and from our end, we have suggested those. However, universities have to go a long way towards updating their respective curriculum as per the requirements of the industry,â€? said Dr Pagdiwalla. Collaboration Is The Solution The unanimous solution pointed out by the industry, would be that the industry and academia joining hands for a better education system. â€œThere should be an industry-academia nexus wherein the industry should have an active participation when it comes to planning curriculum and methods of evaluation,â€? says Gopinath. He maintained that in the process, students will get a lucid picture of the needs, demands, the latest trends, market logistics and cutting-edge technology in the industry. Says Dr Agarwal, â€œThere is very little interaction between the industry and the academia. I would suggest that universities and colleges should invite experts from the industry who can give lectures on applications of biotech in the industry.â€? â€œIn the final semester, they should be given electives to choose depending on their interest and accordingly, they may be placed in related industries for learning and upgradation of knowledge relevant to their interest,â€? claims Dhale. Experts point out that in terms of evaluation, students should be tested on problems of applications and study of real life cases, which are likely to crop up in their profession. â€œA lot of questions given to students are based on theories which will help them only to a certain extent in their job careers,â€? said Dr Agarwal. But Putti offers a different suggestion altogether. â€œBiotechnology as a course should not be offered to students at an undergraduate level. It should only be offered at a postgraduate level and above. The course delivery has to be research and project based in addition to imparting information through textbooks and classroom lectures. The basics however, need to be imparted as fundamentals at the graduate level as basic biology courses,â€? he says. This is coupled with faculty members handpicked and chosen carefully. This apart, many universities and colleges are reeling under paucity of funds. â€œGovernment should appoint an expert committee that has a time-bound assignment for giving concrete suggestions to upgrade the syllabus in order to align it better for industry requirements. Biotech work is highly cost-intensive. Most institutes do not have enough money to spend on improving quality of education and infrastructure. Improvement is required in terms of upgrading the quality of teachers, giving them good pay packages,â€? says Dr Pagdiwalla. Gopinath gives an interesting suggestion. â€œI would suggest that there should be a Central Board of Control which will consist of members from the government, educational institutions and top industry leaders. Top industry leaders should include CSOs and R&D heads of companies. They should sit together and then chalk out strategies, a practical curriculum and areas where students need to be trained.â€? The focus should be on identifying growth areas spanning for the next five years within the domain of the biotechnology industry and develop a course curriculum that would cater to the talent requirements of these areas. â€œSome of these areas are in genomics, molecular medicine and regenerative medicine. Industry academia partnerships could also help close the gaps that exist in the system. Faculty should be encouraged to participate in globally competitive research programs that will help them benchmark their research projects with work being done globally. Significant infrastructure enhancements would need to be carried out by universities and the government could explore ways to help universities by helping fund these activities,â€? adds Subramaniam. Nayantara Som, Jahanara Parveen & Shalini Gupta ]]> <![CDATA[The way forward...Workforce of the future]]> https://biospectrumindia.com/news/95/2492/the-way-forward-workforce-of-the-future.html https://biospectrumindia.com/news/95/2492/the-way-forward-workforce-of-the-future.html Wed, 05 Aug 2009 11:32:00 +0530 The way forward...Workforce of the future Creating capable and well-trained workforce to support India’s growing biotechnology industry. Some solutions. The prospect of the country losing its competitive edge in biotechnology and the subsequent skills of future workforce has become a matter of significant concern. This is not to say that biotech education is non-existent or is poor in India because there are many examples of institutes running excellent biotech courses and creating a pool of scientists and managers  every year. These schools provide students with tools essential for maintaining a competitive edge in the biotechnology industry and pride themselves on their access to comprehensive training and theoretical programs thus aligning themselves to the needs of biotechnology and pharmaceutical industries. However, these programs should not only be replicated across the country, but institutes and  the government should also come forward to commit resources for the execution of these programs. School of Biotechnology at Jawaharlal Nehru University (JNU) in New Delhi, is an excellent example wherein students are  given a strong theoretical foothold in biotech along with an excellent exposure to practical applications. This is clear from the fact that, the biotech department at JNU has spent more than Rs 1.05 crore on lab equipments in the last three years. With an investment of Rs 2.9 crore, the country’s premier institute is also setting up a BSL3 facility. The institute has developed and transferred more than seven products to the industry in the last two years with active participation of the students. Along with the upcoming BSL 3 facility, the School of Biotechnology has 14 labs for the benefit of the students. Almost all the students pursuing post graduate degree in biotechnology at JNU prefer to choose higher studies over an immediate placement. “Many companies approach the school for campus recruitment. However, our students opt not to go for industry jobs immediately after MSc rather they decide to pursue higher studies and PhD in India or abroad. This is because they are well aware of the fact that they will face stagnation in their career with only an MSc degree,” Dr Rakesh Bhatnagar, acting dean, School of Biotechnology,  JNU says.  Maintaining that biotechnology is an application-based discipline, “many students having gained post-doctoral training abroad have established their own biotech companies, or are working as CEOs, presidents, vice-presidents in well known biotech companies,” he adds. Panacea Biotec, Hindustan Lever, Premas Biotech, Ranbaxy are some of the companies where JNU graduates are either working or are heading the companies. Many of its graduates are also working as faculty members in institutes or universities in India and abroad. Bangalore-based Institute of Bioinformatics and Applied Biotechnology (IBAB) is yet another example. The institute has been an abode to several new scientists and entrepreneurs. To enhance its training and research capabilities, the institute recently upgraded its bioinformatics and biotechnology laboratories with the state-of-the-art facilities. A large number of international scientists who visit IBAB all year round impart a wide range of  knowledge to the students on the recent advances in the biotech industry and academic research. This exercise in turn helps the students to get in touch with the current research,  focus on self-learning capacities and personality development. Modern facilities have helped IBAB to be among the very few Indian institutes which have achieved 100 percent placement record in the life sciences sector. IBAB receives continuing strong support from the Government of Karnataka. In addition, it has received grant support from DST, DBT and MIT. The institute has also been maintaining very close association with the industry and companies like Biocon, AstraZeneca and Merck endowing faculty chairs. Companies like Millipore India and Sartorius have been providing scholarships to IBAB students. A smaller group of private institutions too have been playing an exemplary role in creating biotech talent pool. These institutes have invested significantly towards building good infrastructure, and have started specialized programs in the field of biotech. The biotechnology program at SRM University in Tamil Nadu, works with the local bioscience industry to train students in basic laboratory skills, genetic engineering, protein purification techniques, cell culture, immunology, agribiotech and bioinformatics. The curriculum is kept upto date with an annual meeting with the industry. Besides regular visitation to the industry sites, the institute also runs academic programs planned and executed for industrial requirement. Further, in association with the instrument supplier companies like GE, Spinco Biotech, Chemito, BioRad, and ABI, the institute also facilitates specially structured instrumentation training to its students. Dean of School of Biotechnology, SRM University, Dr K Ramasamy states, “We have concentrated towards the empowerment of our graduates with globally competitive skill and employability. In this regard,  we are supported by an international advisory board-biotechnology which is represented by prof C R Lowe, Institute of Biotechnology, Cambridge UK.” The institute also has a corporate advisory board for biotechnology represented by industry leaders like Dr Rao, vice-president, Orchid Pharma India, Dr K K Narayanan – ABIF India, Dr S Sithanantham, director, Sun Agro, vice-president, Cognizant Technology Services-Life Science to name a few. To give their students a global perspective, the institute has given special attention to exposing its students to the global industry and academic community. And working towards it, the institute has started the semester-abroad program with leading institutes like MIT, UC-Davis, Berkeley, University of Wisconsin, UGA, Warwick-UK, TU Netherlands, NUS Singapore, UNISA,UWA  Australia and also a dual degree program with Warwick UK, UW Australia and University of Lund, Sweden. The School of Chemical & Biotechnology at Sastra University, Thanjavur  is another example where the institute is putting in every effort towards creating efficient bioscience workforce. The school of biotechnology offers specialized and denominated postgraduate programs such as bioinformatics, chemical engineering, industrial biotechnology and medical nanotechnology, besides PhD programs. With emphasis on experimental learning, the institute offers innovative academic programs and continuously upgrades its curricula. The school is equipped with state-of-the-art laboratories that provide adequate hands-on-training to the students in techniques of biotechnology, experienced faculty and a curriculum tailored to suit industrial needs. Equipment worth over Rs 4 crore have been housed in the life sciences block. The programs offered by this biotech school are focused towards preparing students for leadership in the development and commercialization of advanced technologies. It strives to keep its students abreast of the progress in the frontier areas of biotechnology. Many of its students and faculty members have received fellowships from the Indian Academy of Sciences, DBT, Tata Institute for Fundamental Research and National University of Singapore. These are the few institutes who have responded to workforce needs by creating innovative programs to prepare future workers for the Indian bioscience industry. The 400-odd biotech institutes in the country have realized the need to interact more with the industry around them to finetune the specifics of skill-training.  However, the number of institutes offering biotech education of this standard are very few compared to the number of people actually required by the industry. Therefore, such efforts need to increase and more importantly, they need to be promoted by the government. Although there are many post graduate courses in biotechnology being run by several colleges and universities across India, but they do not focus on hands-on-training of students in laboratory biotechniques to the required extent. Talking about the of lack of good infrastructure, insufficient manpower for training, lack of knowledge among the faculty or an improper curriculum, Dr Shrikumar Suryanarayanan, director general, ABLE says, “The significance of in-house research activities is not realised in many institutions. As a result, while there are several hundreds of biotechnology degree-holders emerging every year in India, there seems to be an unfulfilled requirement of  reliable technical expertise, in the area of biotechnology.” He suggests that the courses that aim at filling this gap in the human resources have to be redesigned. There is an urgent need for world class institutions. The institutes should strengthen basic sciences like immunology, cell biology, recombinant technology and government can play a critical role in this space. Most of the companies have to invest significant amount of  money and time in preparing them for the industry. Thomas Putti, president, National HR Life Science Forum and Head, HR with Advinus Therapeutics shares, “We have to get students to unlearn and re-learn many practices, once they step into the organization. Intense training to make them job-ready is imparted, depending on the function, they join. These are structured classroom and on the job training interventions, whose course content is designed and delivered in-house. There is a huge investment in training both in terms of time, money and efforts by most organizations today in India.” Given that there is an increasing and critical need nationally in both academia and industry for people trained in the field of biotechnology, the reasons for offering denominated degree in biotechnology are clear. The gap between the needs of the industry and the aspirations of academic community is also very large. There is a strong mismatch in perceptions of the two on the issues related to technology development. While academicians involved in education are clear about the basic research requirements, the industrial needs are not always well understood and met. So the pertinent question that remains is: what does this industry want from biotech colleges and universities? Jahanara Parveen ]]> <![CDATA[Sastra University, No.1 Private Biotech School]]> https://biospectrumindia.com/news/95/2311/sastra-university-no-1-private-biotech-school.html https://biospectrumindia.com/news/95/2311/sastra-university-no-1-private-biotech-school.html Wed, 05 Aug 2009 10:57:00 +0530 Sastra University, No.1 Private Biotech School 5th BioSpectrum Biotech Schools Survey 2009—Methodology The BioSpectrum Top Biotech Schools study includes institutions offering BTech, Masters and PhD courses but not of BSc courses. This study was conducted during April-June 2009. The ranking is based on measurable and quantifiable data. The research team did not seek perceptions and opinions of stakeholders such as students or industry to rank the institutes. BioSpectrum team sent questionnaires to over 200 institutes and followed up with them. We received about 50 questionnaires. Step - I: Identification of Parameters for Ranking of the Institutes Like the previous year’s studies, the parameters suitable for ranking of the institutes were identified in consultation with experts from the industry, education and R&D. Over 10 experts were consulted. Faculty, industry interface, infrastructure and placements emerged as the most important parameters. Step - II: Importance Ranking of the Parameters Structured questionnaire was used to take opinion on relative importance of the four parameters prior to the study. Their opinion was sought for deciding on weights to be assigned to each parameter. The following means emerged based on data received from experts: Faculty, infrastructure, and industry interaction had emerged as the two most important parameters ahead of placement. Step - III: Data collection, analysis and ranking of the institutes A pre-tested structured questionnaire was sent to Directors/ Principals/ Deans of Biotech institutes by the BioSpectrum team. BioSpectrum scrutinized and validated the responses given by the institutes for accuracy, consistency and sufficiency of the data, data entry, analysis of the data and ranking of the institutes. The research team spent considerable amount of time accurately analyzing the filled in data for each institute. For each institute, a score was arrived at for each parameter. For a particular parameter, the score was a composition of each of the sub-parameters. Faculty score of an institute would be composed of faculty per student, qualification of faculty members, research articles published, contribution of the faculty to national and international journals, patents filed and granted. Infrastructure score would be similarly composed of capital expenditure on lab equipment and consumables, expenditure on books and journals, and availability of dedicated and shared PCs per student. Similar scores were arrived at for industry interaction and placement using sub-parameters. Appropriate and largely consistent weights were used for sub-parameters wherever necessary. Sub-parameter scores were indexed with hundred points being granted to the institute with highest score for a particular sub-parameter. Indexed scores were than added up for each institute to arrive at the Total Score for a particular parameter. Scores were than averaged on hundred. Each of the parameters (faculty, infrastructure, industry interaction, and placements) was further weighed as per weights provided by experts to arrive at the total score of an institute. The institutes were than ranked as per this score on an overall basis. The Ranking was done separately for the Public and Private Institutes. Ranking Parameters Faculty: Faculty per student; faculty qualification; faculty experience; publications by the faculty in national and international journals at different points of time; and patents filed/granted both national and international at different points of time. Infrastructure: Expenditure on library; expenditure on lab equipment and consumables at different points of time; and labs per student. Industry Interaction: Products developed by the institute in production; projects sponsored to an institute from industry and government sources; and royalty inflow at different times. Placements: Visits of companies for campus recruitment; job offers during campus placement; number of students placed against needed; number of job offers against needed; and salary offered during the campus placement. Weights: Infrastructure-32; Faculty-28; Industry interaction-28; and Placement-12 ]]> <![CDATA[JNU, Top Public Biotech School]]> https://biospectrumindia.com/news/95/7484/jnu-top-public-biotech-school.html https://biospectrumindia.com/news/95/7484/jnu-top-public-biotech-school.html Wed, 05 Aug 2009 10:56:00 +0530 JNU, Top Public Biotech School India is one among the select few countries in the world to impart biotech program as a specialization at higher levels of education mainly, at the postgraduation and engineering levels. Considering the fact that biotechnology is considered as an inter-disciplinary field of various aspects of science, the Department of Biotechnology (DBT), under the ministry of science and technology in India, has played a pivotal role in progressing the biotech education in country. Today, some of the institutes are known globally for their academics. While the government has been actively supporting the growth of biotech education, there have been several private biotech institutes which have mushroomed in the country providing industry-oriented biotech programs. BioSpectrum has over the past few years tried to map the progress of the institutes imparting biotech education through its annual survey of the Biotech Schools. It ranks institutes and colleges, which are imparting education at the BTech, MTech, MSc or PhD level in biotech. Delhi-based Jawaharlal Nehru University (JNU) emerges as the top institute in the overall ranking. It is followed by University of Hyderabad, Hyderabad, at the second position, Rajiv Gandhi Center for Biotechnology (RGCB), Thiruvananthapuram at the third position, Institute of Chemical Technology, Mumbai at the fourth and Tezpur University, Tezpur, at the fifth position. Tezpur University is a first time entrant into to the Top 5 Schools. The ranking has been separately arrived for both public and private schools as well and we present the ranking and profiles of institutes in these two categories as distinct sections in the ensuing pages. Read on to find out how each of the schools fare on various parameters. ]]> <![CDATA[Smiles with cry1C gene]]> https://biospectrumindia.com/news/95/1986/smiles-with-cry1c-gene.html https://biospectrumindia.com/news/95/1986/smiles-with-cry1c-gene.html Wed, 08 Jul 2009 15:11:00 +0530 Smiles with cry1C gene Even as a cloud of uncertainty has gathered over the moves to approve the country’s first GM food crop, Bt brinjal, India’s biotech regulator has given the industry a big reason to cheer. The Genetic Engineering Approval Committee (GEAC) has given its approval to a new “genetic event 9124” to use the novel synthetic gene, cry1C, in two Bt cotton hybrids (MH 5125 and MH 5174) developed by Bangalore-based Metahelix Life Sciences. From the time India’s first Bt cotton hybrids containing cry1AC genes, developed by global seed giant, Monsanto were introduced in 2002, experts have been stressing the need to have home-made genes. Now an Indian company, started by homegrown experts, has demonstrated the capability to develop a newer version of the gene, without help from any public or private laboratory. In fact, the new hybrids from Metahelix will match the 2nd generation Bt cotton hybrids released by Monsanto incorporating its proprietary cry2AC genes. The new gene-based hybrids will protect the crops against its two major pests—bolloworm and spodoptera—with a single gene. This outstanding achievement by the Metahelix team, led by KK Narayanan, is significant for two reasons. One, the cry1C gene will become an alternate technology platform to Monsanto’s and other seed giants’ cry1AC based crop protection system. The cry1AC gene has been in use for over a decade around the world and there is every possibility of the major cotton pest, bollworm, mutating to develop resistance to this gene. The world will have an alternate option should that happen soon. Second, a lot of opposition to the GM technology in India, to a large extent, was also based on the fact that the royalty or technology fee on the Bt cotton seeds went to a multinational giant. With the home-grown Metahelix in a position to transfer this technology at affordable rates to Indian seed companies, the future GM products in India could run less risk of opposition from a wide range of anti-GM activists. Metahelix, angel funded by Nadathur Holdings of one of the co-founders of Infosys, NS Raghavan, and supported by Kotak Mahindra Private Equity Fund, has managed to get commercial approval for the cry1C gene with an investment of just Rs 50 crore. Hence, it will be in a position to rewrite the rules of the game, if it plays its cards right. Metahelix could well turn out to be the “game changer” for India’s BioAgri industry, in the same manner in which Shantha Biotech’s Varaprasad Reddy, influenced the course of the country’s fledgling biotech sector with his home-made Hepatitis B vaccine in the late 1990s. The baton of ministerial leadership in the science and technology ministry has meanwhile been handed over to Prithviraj Chavan from Kapil Sibal. A foreign-educated engineer by profession, Chavan has already had a round of discussion at a closed-door session with industry leaders in Bangalore in mid-June. The industry has given him the wish list and also pleaded for increasing access to the fruits of biotech efforts to Indian citizens. The government which swears by the aam admi (common man) hopefully will listen to the industry’s suggestion. Chavan continues to wear his other hat as the minister in the Prime Minister’s Office (PMO) and hence will have additional influence over policy making in the current government. The July issue has the second part of the 7th BioSpectrum-ABLE Biotech Industry Survey, focusing this time on BioSuppliers, the key companies that keep the biotech research going with their invaluable equipment, material and service support. There is some churn at the top with Waters emerging as the No.1 BioSupplier in 2008-09. The segment growth also mirrors the figures of the biotech industry closely. The ranking table too has undergone  some major changes due to more systematic data capture this year to reflect more accurately the business done by these companies  with the life sciences institutions. Some of the industry leaders opted out of this year’s survey due to decline in sales numbers induced by the recessionary market conditions. The biotech industry continues to look forward to this exercise in benchmarking the critical enablers of the life sciences ecosystem. Hopefully, things will be back to normal by the time the next survey is done in June 2010. <sureshn@cybermedia.co.in> ]]> <![CDATA[Rank 21-27 Companies]]> https://biospectrumindia.com/news/95/5888/rank-21-27-companies.html https://biospectrumindia.com/news/95/5888/rank-21-27-companies.html Wed, 08 Jul 2009 14:11:00 +0530 Biotron Healthcare  clocked a total sales of Rs 13.5 crore for fiscal 2008-2009. Since its inception in 1998, the company has been focusing in key areas in life sciences such as new drug discovery research, rapid kit manufacturing and biosensors, molecular imaging, molecular diagnostics and automated nucleic acid extraction systems. Its product range includes microplate multi-detection systems; liquid handling systems; rapid kit and biosensors manufacturing systems; compound storage and management systems; gene expression kits, PCR and qPCR systems and kits; kits for GPCR, kinases, inflammation and CNS; and automated nucleic acid extraction systems. The company has marketing alliances with BMG Lab Tech, Germany; Cepheid USA; PSS Japan; CIS BIO France; Sacace Italy; Quanta UK; Panomics (Affymetrix) USA; Biodot USA; Ipsogen France and Matrical USA In the avenue of new drug discovery research, Biotron has  an alliance with BMG Lab Tech, Germany, wherein the latter  offers a comprehensive range of Multi-label Detection Systems based on non-radioactive detection technologies (absorbance, fluorescence and luminescence). This happens to be the flagship product. In this avenue, Biotron offers a  supply of homogeneous time resolved fluorescence (HTRF) assays for GPCR, kinases, inflammation and CNS. In the field of molecular imaging,  the company offers in-vivo pre-clinical imaging including X-ray micro CT (computed tomography), MRI (magnetic resonance imaging) microscopy, Micro-PET (positron emission tomography), Micro-SPECT (single photon emission computed tomography) and optical (luminescence and fluorescence). The nuclear imaging modalities (PET and SPECT) can provide the sensitivities required to obtain the same physiological imaging acuity in small animals as can be obtained from humans. Biotron has just entered into a distribution arrangement with ART Canada for supply of optical-based in-vivo animal imaging systems. Biotron has also forayed into automated nucleic acid extraction systems. Biotron through its technical collaborative arrangement with PSS Japan is going to develop and manufacture extraction kits in India. Started in the year 1992, JH BIO Innovations is a medium-sized innovative company based out of Bangalore with operations in seven other cities. JH Bio Innovations has registered revenue of Rs 13.10 crore. The company is one of the leading companies in India having an all India presence and working with some of the world leaders like ThermoFisher, Alpha Innotech, Operon, and Evogen among others. The product ranges include frontier technology product range to the low-end regular and standard instruments, reagents and technical solutions. The very idea of this is to penetrate into all laboratories with products and services to convert them to our customer needs. The company’s product range includes electrophoresis, PCR, gel documentation systems, spectrophotometers, centrifuges, deep freezers, freeze dryers  and high-end instrumentation like real time thermolcycler, liquid handling systems, high-end imaging systems. And the services offered by the company include providing the total solutions to any particular requirement of different segments of this vertical. This has enabled the company to build a large and strong customer base. JH BIO Innovations is one of the market leaders in imaging systems and micro-volume spectrophotometers across India. The company has taken initiatives to enhance the whole range of UV-VIS spectrophotometer market with over 15 models and several world brands from ThermoFisher Scientific. Trident Equipments, is a steadily growing enterprise established in 1998. For fiscal 2008-09 it clocked an annual sales of Rs 12 crore. The company specializes in the field of analytical, process and life science instrumentations. Trident’s client list includes  names like UNICEF, NTPC, BARC, Reliance Energy, Ranbaxy, Dr. Reddy’s Labs, Astra Zeneca, Novartis, USV, NCL, IIT, ICAR & CSIR Labs, Ciba, Colorchem, Bayer, Colgate Palmolive, HLL, Emerson and  Yokogawa. The company represents some of the world’s leading companies in the field of electrochemistry, spectroscopy, color analysis, drug discovery, process analysis, biotechnology and microbiology. It offers products and services in lab equipments like pH meters, shakers,Co2 incubators, deep freezers, roll in systems, air samplers, spectrophotometers and ToC analyzers; and drug discovery systems like liquid handling systems, PKA/LOGP systems, solubility and permeability systems and rapid microbiological identification systems. Trident has marketing alliances with companies like Thermo, Cybio, Shellab, Bellco, Biochrom, GE and Biomerieux. Lately, Trident has grown at a steady phase in its electrochemistry  line of products which is the most widely employed technique in any laboratories. The applications of electrochemistry  line of products may range from understanding parameters like acidity, alkalinity, conductivity, temperature, turbidity, concentration, BOD, COD, etc. of a liquid sample. Trident represents some well-known brands for supplying equipments like ovens, incubators, furnaces and chambers. The SHEL LAB line of laboratory equipment faces industrial, clinical, and laboratory applications with ease. BI Biotech India was formed incorporating business of the Biotech India, which has been in the business of distribution of quality biological research reagents for over 20 years. The company has been distributing products of principal companies of USA and Europe including R&D Systems, Superarray Bioscience Corp, Ray biotech, Santa Cruz Biotechnology, Bellco Biotechnology, USA Scientific Inc amongst others. BI Biotech India has established itself as a major distributor of research reagents, consumables and equipments for proteomics, genomics, cell biology, immunology, healthcare and drug development. Its mission is to deliver superior research management solutions through a focus on excellent customer service and prompt technical support. BI Biotech India is proud to state itself as a dedicated company because it tries to understand customer needs and work with them closely, always looking for ways to improve its services. One of the factors behind its success include its impetus to a good warehousing for perishable reagents like ELISA kits, recombinant proteins, primary and secondary antibodies, gene array products, siRNA products, transfection reagents etc.  It represents some of the US-based world renowned companies like  Anaspec, Bellco Glass, GlobalStem, R&D Systems, RayBiotech, Santa Cruz, SABiosciences and USA Scientific. Besides these, BI Biotech also distributes products from Abnova, Taiwan; Bachem AG, Switzerland; Cedarlane Laboratories, Canada; Major Science, Taiwan; IKA, Germany; and VWR International, UK. With a comprehensive range of products under its product portfolio, it is fully-equipped to meet scientists/researchers growing demand. Bangalore-based Automed is a life science services company offering  solutions for automation of life sciences processes and instrumentation for drug discovery, microbiology, biotechnology, liquid handling, temperature control, sterilization and validation applications. The company has clocked revenue of Rs 9.8 crore in the year 2008-09. The company offers knowledge-based solutions for the life science community and  specializes in the areas of microbiology and biotechnology automation. Automed along with  international principals have over the last seven years emerged as the most respected, preferred partner of Indian scientific, healthcare and life science community. The company currently supplies products from Wheaton Science Products, USA; AES Laboratories, France; Integra Biosciences, Switzerland; MRC, Israel; Orange Scientific, Salvis Labs and few more manufacturers.  Automed Systems offers complete solutions for microbiology applications. It has products to offer right from sampling to analysis and validation of your results. All the products of Automed Systems are GMP and CFR compliant. Axiom Biotek, a partnership venture under the aegis of Uniline Group was started in the year 2004. The company works in close association with Uniline to take the synergistic growth path by utilizing the strengths of Uniline Group, which is in business for more then two decades with about 150 plus employees on its roll. Axiom Biotek has more than 20 associate offices at different locations across the country. The company represents principals such as Steris Corporation, USA; CSK-Bio, Switzerland; Integrated Containment Systems, USA; Anseros, Germany; TSE Systems, Germany; Biozone Global, UK/US; Aquatic habitats, US; Charles River Laboratories, UK/US and AIMS, US. Axiom Biotek aims to be a trusted and valued resource in the advancement of life science and pharmaceuticals to protect people from the dangers of infection and contamination. The company also aims to earn a  position as a trusted partner with its customer base by enhancing customer productivity and profitability and customizing preventive maintenance programs to meet evolving safety guidelines. The Murine ImmunoComb Kit offered by Charles River Laboratories is a convenient solid phase immunoassay designed for the routine screening of rodents for viral and mycoplasmal antibodies. The kit is based on the enzyme-linked immunosorbent assay (ELISA) and is completely self-contained. Privately-owned Chromous Biotech is  based in Bangalore. It was started in 2006 by  Dr Biswajit Roy who has been both CEO and managing director of the company since its inception. The main objective of the company is to help the scientific community with  research products and molecular biology services. The company produces and markets research reagents like restriction and modifying enzymes, research kits, among others for all related areas of biological research. The company also undertakes contract research services. Chromous  has sales and marketing offices in Bangalore, Mumbai, Delhi, Kolkata, Hyderabad and Chennai and has business activities across the country. The company has only two shareholders with Dr Biswajit Roy holding the majority stake. Chromous Biotech is one of the few companies that has the range of products and services in molecular biology and provides complete molecular biology solutions to the scientific community in India. The company is looking at starting operations in North America and is keen on  a dealership and distributorship in that region. ]]> <![CDATA[Axygen Scientific looks beyond instrumentation]]> https://biospectrumindia.com/news/95/2893/axygen-scientific-looks-beyond-instrumentation.html https://biospectrumindia.com/news/95/2893/axygen-scientific-looks-beyond-instrumentation.html Wed, 08 Jul 2009 14:03:00 +0530 Axygen Scientific looks beyond instrumentation While retaining its leadership in instrumentation, Axygen Scientific is now strengthening its presence in molecular biology reagents and liquid handling systems amongst others. Axygen India is an offshoot of Axygen, USA, and has set many milestones in the biotech supplies. The company has been growing at enviable pace of around 40-50 percent in India annually. The year 2008-09 saw revenues of Rs 29.5 crore with  a growth of 33 percent as against the Rs 22.50 in fiscal 2007-08 with instruments being the major contributor for the growth. Axygen has established itself as one of the top companies in India supplying plastic disposables used in high-tech research and then started diversifying into instrumentation and other areas in 2004-05. Labnet International was the first company which gave Axygen a foothold in the instrumentation market. It is a US-based company that  operates in 55 countries globally. This was followed by a series of tie-ups with instrumentation companies like Nuve from Turkey, Poly Science from USA, Scie-Plas from UK and Hoefer from USA. The company’s presence in the instrumentation field can be easily accessed by the number of installations (between 1200-1400) in various parts of the country. Axygen is perhaps one of the strongest players in electrophoresis in Indian market comprising  horizontal, vertical electrophoresis, electro blotting systems and manual DNA sequences and has now set its goals on 2D electrophoresis systems and already completed some of the installations in this area. Axygen is a leader in the high throughput areas in India having a market share of around 60 percent. In line with its mission to be one-stop-shop, Axygen entered into molecular biology reagents through its collaboration with Serva of Germany which contributed to more than one crore rupees in the company revenues in 2008-09. Another collaboration was with Flourotechnic, an Australian company specializing in vital fluorescent dyes and The Gel Company which is having a strong presence in the world market in capillary regeneration. Axygen India has also tied up with Wellpro, the company dealing in liquid handlers, and got its first installation in Mumbai through a WHO funded project. The machine has now installed in Enterovirus Research Center, Mumbai; an ICMR institute. The company has also focused on outsourcing of certain business such as sequencing and oligos. In order to strengthen its market share in the molecular biology reagents, Axygen launched innovative range of taq polymerase, hot start taq, DNTPs, PCR master mixes and Q PCR master mixes. Talking about the plans for the future Navneet Trehan, CEO, Axygen, said, “We have plans to introduce new products in this range in the next two-three months. The company plans to strengthen its presence in molecular biology reagents, robotics and genomics.”  ]]> <![CDATA[Medispec India retains steady growth]]> https://biospectrumindia.com/news/95/1281/medispec-india-retains-steady-growth.html https://biospectrumindia.com/news/95/1281/medispec-india-retains-steady-growth.html Wed, 08 Jul 2009 13:58:00 +0530 Medispec India retains steady growth Despite forex fluctuations, the year saw Medispec India achieve a decent growth through its alliances with its main principles and businesses coming from academic institutions. In fiscal 2008-09, Medispec clocked a biotech sales of Rs 30.30 crore (excluding its diagnostics revenue). Incorporated in 1995, Medispec India Limited (MIL) is involved in marketing, distribution, installation, servicing and calibration of hi-tech biomedical, analytical, scientific and diagnostic systems. MIL is ISO 9001:2001 certified and represents prominent overseas manufacturers for their diversified product range with main thrust on biotechnology and molecular biology. The company serves a large market segment that includes a large set of clients. Some of the companies represented by MIL in India are— Bio-Tek Instruments, USA; Nuaire, USA; UVP, UK; Celsis, UK; Labcaire, UK; Nickel Electro, UK; Polygen, Germany; LGM, International, USA; Iris Sample Processing, USA; Sperion Protection Clothing, France; and Seracare, USA. One of the milestones for the company was joining hands with BioTek Instruments thus forming BioTek Instruments India. This division contributes about 40 percent of the total revenue for MIL. BioTek is a supplier of multi-detection microplates, microplate washers and microplate spectrophotometers. MIL employs about 50 people at its offices in Bangalore, Chennai, Delhi, Hyderabad, Chandigarh, Kolkatta, Lucknow, Pune, Ahmedabad, Bhopal besides Mumbai.  MIL also has operations outside India in Sri Lanka, Bangladesh, Nepal and Bhutan.  While in Nepal it is more of institutions and in Bhutan it is more of clinical research centers. MIL also has plans to enter the Gulf region in the form of technical support for high-end machines.  In India, there are also plans to set up an office in Guwahati, Assam.    In fact, the company in the last fiscal, saw  growth of businesses from the government sector especially  from academic institutions and colleges.  Vippul Chhatbar, CEO, Medispec India, said, “Education is one area where the government is investing and spending money. So that was a blessing in disguise because the year saw pharma companies not going into many investments because of the slowdown.” The year also saw a significant growth in  their business with  Nuaire, USA, achieving a business sales close to $2 million. MIL also saw significant growth in its diagnostic business  and clocked an annual sales of Rs 5 crore The division  which commenced operations in India last year, has come up with tests for cancer testing and prevention. “Other areas where we are working on finding latest diagnostic tests are in TB, malaria, leptosporosis. We are also in the process of launching external quality assurance tests for infectious diseases,” said Chhatbar.  ]]> <![CDATA[PerkinElmer expands its frontiers]]> https://biospectrumindia.com/news/95/1380/perkinelmer-expands-its-frontiers.html https://biospectrumindia.com/news/95/1380/perkinelmer-expands-its-frontiers.html Wed, 08 Jul 2009 13:57:00 +0530 PerkinElmer expands its frontiers Established in 2007,  PerkinElmer India has consolidated its stand in India and has ambitious plans on going forward PerkinElmer India reported a turnover of Rs 140 crore for the year 2008-09. The company’s life sciences business accounted for 27 percent of this amounting to Rs 37.80 crore. A wholly-owned subsidiary of PerkinElmer, the company operates as direct sales, service and marketing operation targeting India’s thriving life science and analytical instrumentation markets. Globally, the company reported revenue of approximately $2 billion in 2008, has around 8,500 employees serving customers in more than 150 countries, and is a component of the S&P 500 index. The company provides precision instrumentation, testing systems and components, software and services for a wide range of scientific and industrial laboratory applications. Its products are used in predictive diagnostics, personalized medicine and environmental monitoring. PerkinElmer India currently employs approximately 170 people in Bangalore, Baroda, Chennai, Hyderabad, Kolkata, Mumbai, New Delhi, Pune, Lucknow, Chandigarh and Thiruvananthapuram. PerkinElmer’s cellular imaging and analysis product regime includes high content screening systems and image-based analysis with platforms like Operetta, live cell imaging systems and softwares like Acapella, Volocity and Columbus.  In analytical sciences space,  products range includes FTIR and FTNIR spectrometers, UV/Vis and NIR spectrometers-Raman spectrometers and imaging systems, elemental analysis (TEA) atomic absorption (AA) spectrometers, coupled plasma (ICP) mass spectrometry (MS), gas chromatographs and MS¯liquid chromatographs (LC, HRLC and  UHPLC), microscopy and imaging system-other hyphenated techniques, data systems and laboratory information management (LIMS) validations. PerkinElmer  has a  Biodiscovery division  which mainly caters to the drug discovery customers with specialized tools for cell biology related research. It has a plethora of reagents, consumables and instruments which facilitate detection analysis and further screening and profiling of various classes of druggable targets like esp. kinases and GPCR’s. The company has  also set  up a state-of-the-art Center of Excellence at Mumbai. In addition to this recently the company has announced its plans to establish a biopharma Center of Excellence in Hyderabad. This center which will open in October, 2009, will be the second high-tech facility recently established by PerkinElmer in India. The Hyderabad facility complements the recently-opened PerkinElmer EcoAnalytix Center of Excellence facility in Mumbai, established in May 2008 and dedicated to environmental health sciences. The new biopharma center will provide regional PerkinElmer clients and partners in India with access to established and emerging drug discovery and pharmaceutical quality assurance and control applications and technologies, training facilities and expertise. ]]> <![CDATA[Jain Biologicals cashes in on lab products]]> https://biospectrumindia.com/news/95/1427/jain-biologicals-cashes-in-on-lab-products.html https://biospectrumindia.com/news/95/1427/jain-biologicals-cashes-in-on-lab-products.html Wed, 08 Jul 2009 13:54:00 +0530 Jain Biologicals cashes in on lab products Jain Biologicals not only supplies lab products and plastiware but is also into liquid handling systems and cell culture media thus meeting the needs of research institutes and Indian biotech industry. Jain Biologicals is a privately-owned company  that has introduced  state-of-the-art  products in India in the healthcare and biotechnology. The company has an excellent marketing machinary and service and technical support staff  that is capable of distributing 10,000 products catalogues all over India to various scientists, researchers, technicians working in institutes, pharmaceuticals and  hospitals. The company aims at providing innovative products and information to its large database of clients all over India, providing in-depth application support, offering prompt before and after sales support, and ensuring that its organizational culture is geared towards total customer satisfaction. It has seven offices located at Chandigarh/Panchkula, New Delhi, Varanasi, Hyderabad, Chennai, Bangalore and Pune with a countrywide network of 80 distributors supported by a strong marketing/sales team. Both the distributor and marketing people together focus on our client’s queries in all the corners of India.  Some of the principals represented include Greiner Bio-One, Germany, a An DIN EN ISO 9001 company dealing with complete range of plasticwares, tissue culturewares, immunology, high thoughtput screening, microtitration, molecular biology and many others products. The company also supplies a complete range of liquid handling and  dispensing systems from Eppendorf , Germany. PAA Laboratories, Austria is another principal having a complete range of foetal calf serum, foetal bovine serum, bovine serum albumin, cell culture media, balanced salts solutions, reagents, detachments enzymes, attachment, celltype specific media, mycroplasma-free cell culture and diagnostic products. The product portfolio is completed with Advanced Scientifics,  USA, a pharmaceutical/biotech company manufacturing single use containers/bioprocessing bags offering specialized transfer/purification tubing assemblies for research application. Pharmaceutical companies which rely on products supplied by Jain Biologicals include. Zydus Cadila Healthcare, Cadila Pharmaceuticals, Astra Zeneca, Dr. Reddy’s Lab, Orchid Pharmaceuticals, Haffkins and Wockhardt besides others. Biotech companies such as Shantha Biotech, Biocon India, Aurigene Discovery Technologies and Bharat Biotech and other companies use its products. The company has a strong reach within 250 government research institutes all over India. The company’s future strategy is to bring innovative products and information for its  clients while also maintaining and increasing its customer database.  ]]> <![CDATA[Beckman Coulter expands product portfolio]]> https://biospectrumindia.com/news/95/2682/beckman-coulter-expands-product-portfolio.html https://biospectrumindia.com/news/95/2682/beckman-coulter-expands-product-portfolio.html Wed, 08 Jul 2009 13:45:00 +0530 Beckman Coulter expands product portfolio Since its inception, Beckman Coulter India’s growth in India has moved ahead to make its life sciences business triple this year. Beckman Coulter India  is a wholly-owned direct subsidiary of Beckman Coulter, USA. Beckman Coulter is a leading manufacturer of biomedical testing instrument systems, tests and supplies that simplify and automate laboratory processes. Spanning the biomedical testing continuum¯from pioneering medical research and clinical trials to laboratory diagnostics and point-of-care testing¯Beckman Coulter’s 200,000 installed systems provide essential biomedical information to enhance health care around the world. Globally, the parent company is a consequence of a merger between Beckman Instruments and Coulter Corporation in 1998.  Prior to establishing a direct subsidiary in India, for 16 years, the company was represented in India through a reputed distribution channel. In India, in the past fiscal, the company garnered a total turnover of Rs 48 crore as against Rs 24 crore in fiscal 2007-08. Commenting on its growth, Dr Chandrasekhar, managing director, Beckman Coulter India, said, “Last year in particular was a landmark year  for our life sciences business. We tripled our business here and overall our business is two-and-a-half times from what we were in the first year. We did  have some major breakthroughs in centrifugation. The year 2009-10 will be the year of flow cytometery. We launched some exciting products some of which are pretty unique be it in the field of centrifugation and some cancer markers some of the most advanced flow cytometery analytical systems and the most advanced cell sorting systems.” For Beckman Coulter India, the diagnostic and life science research portfolios have been major growth contributors in this subsidiary’s total sales revenue. In life sciences, the company has a product portfolio ranging from centrifugation, research flow cytometry, automation, proteomics, genomics and analytical instruments. The company mainly caters to the Indian diagnostic industry (hematology, immunochemistry and biochemistry), biopharmaceuticals (R&D/quality control), discovery research and government funded research institutes, pharmaceuticals and allied industries.  Amongst its portfolio of products this year, Gallios analyzer , a new flow cytometry has been added to its kitty of products. It is the first in a series of key flow cytometry instruments and software reagents to be announced throughout the year.  “Overall all our businesses within the life sciences space have done well. Centrifugation has been doing well and around 80 percent of our business comes from this portion and it has had a modest growth of over 24 percent compared to other businesses,” said Dr Chandrasekhar.  ]]> <![CDATA[Towa Optics enhances distribution network]]> https://biospectrumindia.com/news/95/2519/towa-optics-enhances-distribution-network.html https://biospectrumindia.com/news/95/2519/towa-optics-enhances-distribution-network.html Wed, 08 Jul 2009 13:41:00 +0530 Towa Optics enhances distribution network     Towa supplies microscopes for different category of users from basic student microscopes to the advanced motorized microscopes for research and diagnostic laboratory users. Towa Optics is the authorized distributor of many reputable international companies such as Nikon,  (Japan), Media Cybernetics (USA), Linkam (UK), Thermo Electron ( USA) and Laboratory Imaging (Czech Republic). It provides various instruments and equipments like biological microscopes, image analysis systems, cooled/uncooled scientific cameras, semiconductor inspection equipment, controlled environment equipment and histopathology/cytology products.  The company supplies microscopes for different category of users from basic student microscopes to the advanced motorized microscopes for research and diagnostic laboratory users from Nikon including upright microscopes, inverted microscopes, stereozoom microscopes, mulltizoom microscopes, confocal scanning laser microscopes, digital microscopes and intergrated live cell imaging systems. The company supplies Nikon’s new BioStation incubator imaging systems that take live cell imaging to new levels of sophistication by providing consistent environmental control of temperature, humidity and gas concentration when managing, observing and recording cell growth, morphology, and protein expression in culture.  Other products offered include Biostation IM that delivers remarkably high signal to noise ratios, producing fluorescence images that reveal more than ever before and BioStation CT, the world’s first integrated cell culture observation device that allows imaging experiments to be conducted without ever removing the cells from the incubator. Consisting of a standard sized tissue culture incubator with an inverted design microscope inside, BioStation CT holds 30 vessels ranging from 24 well plates to 75cm2 flasks, which are moved between the microscope stage and the vessel rack via a robotic device while maintaining precise levels of CO2, humidity and temperature. Pathology equipments supplied by the company include tissue processors, pathology workstations, microtome, cryostats, cytocentrifuge, tissue embedding systems and slide strainers. Towa also offers a broad array of high-quality centrifuges from Thermo Fischer Scientific, USA, to support applications including clinical and blood banking, microbiology, tissue culture, molecular biology and genomics, drug discovery, and proteomics. The company also has image processing software for scientists and professionals in research, medicine, production and quality control from Media Cybernatics. Towa Optics also has cryo-preservation systems from Thermo Scientific designed to meet the rigorous storage requirements of cryogenic samples and ultra-low temperature (ULT) freezers designed to store and protect critical samples. ]]> <![CDATA[DSS Imagetech thrives on research services]]> https://biospectrumindia.com/news/95/2259/dss-imagetech-thrives-on-research-services.html https://biospectrumindia.com/news/95/2259/dss-imagetech-thrives-on-research-services.html Wed, 08 Jul 2009 13:31:00 +0530 DSS Imagetech thrives on research services DSS Imagetech offers latest technologies in microscopy, life sciences research, clinical diagnostics, imaging, genomics, proteomics and molecular diagnostics thus aiming to be a total solution provider. DSS Imagetech is a major solution provider in the Indian biosuppliers market. It provides cutting-edge technology solutions to researchers and clinicians working in areas like genetics, drug discovery, and biotechnology. Its range of products and application areas include microscopy, image analysis software systems, genetic workstation, ICSI workstations, DNA probes, and microarray readers. The company recorded Rs 78.61 crore in revenues in fiscal 2008-09, compared to 68.04 crore in fiscal 2007-08.  DSS has made a constant endeavor to provide cutting-edge technology solutions to researchers and clinicians in various fields of life sciences. The product basket extends beyond just instruments to consumables like antibodies for pathology applications, molecular biology reagents as well as DNA probes for FISH in prenatal and cancer genetics. The company has also set up a training laboratory and conducts workshops for immunohistochemistry as well as FISH for cancer genetics. The company has long standing international alliances with Olympus, Applied Imaging, Media Cybernetics, Genomic Solutions, Illumina, Ultralum, Abott Vysis and an existing customer base of over 4,000 research and clinical institutes in areas such as research and clinical pathology, molecular biology, IVF-ICSI (in-vitro fertilization), genetics, telepathology and teleradiology. DSS provides solutions for a vast number of applications in the field of genomics including cell based assays (for cell growth and cell dispensing), gene discovery, gene ID, gene characterization, differential display, gene expression analysis, arraying, hybridization, drug discovery, compound library management, assay assembly, SNP setup, genotyping, PCR, DNA/RNA synthesis, oligonucleotide synthesis, sequencing, DNA shearing, clone production and low volume sequencing. The fiscal 2007-08 saw consumables and reagents as being the biggest growth driver for the company with Dako (pathology) Takara Clonetech (molecular biology reagents) and Abbott Molecular showing double digit growth. Viral load testing for HIV and HER2NO from Abbott for detecting breast cancer were also revenue grossing technologies. The company has installed quite a few microarrays in the last few years and has been training people in IHC and FISH technologies. The company tied up with Carestream Health that acquired Kodak imaging products and also strengthened its relationship with Beckman Coulter.  ]]> <![CDATA[Genetix Biotech eyes academics R&D]]> https://biospectrumindia.com/news/95/2991/genetix-biotech-eyes-academics-rd.html https://biospectrumindia.com/news/95/2991/genetix-biotech-eyes-academics-rd.html Wed, 08 Jul 2009 13:29:00 +0530 Genetix Biotech eyes academics R&D Molecular biology and cell culture have been the strength of Genetix Biotech last year, it  derives majority of its revenues from the biopharma industry but is now looking at leveraging its business from academia. Delhi-based Genetix Biotech Asia represents market leaders in biotechnology/life sciences, laboratory research products such as filtration membranes and devices, molecular biology kits and reagents, biochemistry, protein assays, fine chemicals, immunology reagents, cell and tissue culture, serum and media, chromatography accessories and various instruments for leading multinational brands. The company registered an approximate growth of 14 percent in the fiscal 2008-09 with revenues of Rs 80 crore up from Rs 70 crore last year. It registered a growth of 42 percent over last year. The company has been growing at an average rate of 30-40 percent for the last several years. The company derives almost 55 percent of its revenues from the biopharmaceutical industry (both R&D and production) with companies such as Reliance Life Sciences, Serum Institute of India, Indian Immunologicals and Shantha Biotech as its clients. About 45 percent of its revenues are derived from the research segment and five percent from diagnostics. Last year has been tough for the company with several factors that prompted industry players to restrain business including recession in the global market. Talking about the growth drivers, Arun Prakash, CEO, Genetix Biotech Asia, said, “The company added three new principals to its portfolio including-Ashnon & Corbett research. Molecular and cell biology and culture business has been our strength both from industry and research point of view. Molecular biology research products from Qiagen and Fermentas have been the best selling products.”  The fiscal 2007-08 saw Stratagene (microbiology) and HyClone (cell culture and bioproduction), two prominent principals return to Genetix with Hyclone contributing close to around 12 crore of the total revenues. A whole range of bioseparation products including filtration, chromatography, ultrafiltration under the Genetix brand was also launched. The company is also working on a project under SIBRI worth Rs 80 lakh sanctioned by DBT in the area of developing molecular diagnostics for two bovine diseases. It also has a full-fledged molecular biology and cell culture laboratory for in-house training, customer demonstration/training and quality control back up. “We have changed our focus from being completely on the industry and focusing on academics R&D. We shall be also getting into manufacturing of various products as well and have plans lined up for that,” added Arun Prakash. ]]> <![CDATA[GE Healthcare makes India business stronger]]> https://biospectrumindia.com/news/95/4630/ge-healthcare-makes-india-business-stronger.html https://biospectrumindia.com/news/95/4630/ge-healthcare-makes-india-business-stronger.html Wed, 08 Jul 2009 13:03:00 +0530 GE Healthcare makes India business stronger GE Healthcare Life Sciences provides cutting-edge technology products and processes to  pharma, biopharma and biotechnology companies and major academic and research institutions globally. Headquartered in the UK, GE Healthcare is a $17-billion unit of General Electric, one of the world’s largest diversified conglomerates. Worldwide, GE Healthcare employs more than 46,000 and its products are used in about 100 countries. The company’s India business recorded revenue of Rs 120 crore for the year ending March 2008-09. GE Healthcare works in the primary areas of healthcare systems (diagnostic imaging and clinical systems), medical diagnostics, surgery, healthcare IT solutions and life sciences. Over the years, the company has significantly increased its focus on its life sciences business in India, driven largely by the growth in the domestic biotechnology sector. Last year, it substantially increased its commercial footprint and service capabilities in India to cater to the customers’ needs faster and more efficiently.  GE Healthcare Life Sciences has been a key supplier of bioprocess, protein purification, chromatography, columns, media and filtration needs to the major players in India in the biotech space and GE’s products and  services are generally regarded by customers as the best-in-class. With around 30 years of experience in biopharmaceuticals, their products and solutions are generally considered to be the gold standard in biopharmaceutical production. Anurag Gupta, managing director, GE Healthcare Life Sciences claims, “About 95 percent of around 120 FDA-approved biopharmaceuticals are manufactured using GE Healthcare Life Sciences’ products. This level of proven leadership is important everywhere and is valued by companies in India.” GE Healthcare Life Sciences has a service team and commercial team  in India with offices at Bangalore, Delhi, Chennai, Mumbai, Hyderabad, Kolkata, Lucknow, Pune and Chandigarh. GE Healthcare Life Sciences has introduced a new portfolio of ready-to-use systems and devices designed for biopharmaceutical production. The ReadyToProcess  portfolio is a range of products designed to meet the biopharmaceutical industry’s need for increased speed, simplicity and safety for all areas of bioprocessing—from cell culture and fermentation to final purification. GE Healthcare Life Sciences recently  acquired MicroCal, a provider of innovative instruments for the study of molecular interactions in pharmaceutical, biomedical and life science research. MicroCal’s proprietary technology, which is complementary to GE Healthcare’s Biacore platform, provides scientists with detailed information across several stages of the drug discovery process, reducing the potential for late-stage drug candidate failures.  ]]> <![CDATA[Shimadzu continues its new launches]]> https://biospectrumindia.com/news/95/2221/shimadzu-continues-its-new-launches.html https://biospectrumindia.com/news/95/2221/shimadzu-continues-its-new-launches.html Wed, 08 Jul 2009 12:27:00 +0530 Shimadzu continues its new launches    Recession did bring a slowdown on  Shimadzu  Analytical’s overall life sciences business, this however did not stop Shimadzu  Analytical India from launching five new products, upgrading its technologies and continuing its R&D projects. Shimadzu  Analytical (India), a subsidiary of Shimadzu Asia Pacific (based out of Japan), has a business focus on offering technologies in the field of  analytical, scientific instrumentation, process control instrumentation and environmental monitoring. Started in 2006 in India, the company caters to a number of industrial segments, with a chunk of business coming from  the life sciences industry.  For its operations in India, Shimadzu  has four marketing partners  namely Spinco Biotech, Toshvin Analytical, Swan Environmental and Amkette Analytics. Shimadzu  Analytical has been operating in the Indian life sciences space for the past 40 years through these distributors. The company in India clocked an annual sales revenue of Rs 154 crore from life sciences alone as against Rs 128 crore in fiscal 2007-08. Apart from life sciences, the company also caters to other industry segments like  automobiles. A break up of their total revenue  shows that around 70 percent of their revenue comes from life sciences alone, while the remaining 30 percent comes from other industries. Commenting on the slowdown in growth, Senya Imamichi, managing director, Shimadzu Analytical India, said, “Last year we were expecting a growth of 15-17 percent, but due to the sudden economic crisis and recession worldwide, there was a slowdown in our growth. However, there might have been slowdown but we did not see any negative growth in our business in India.”  Since most of Shimadzu’s business transactions happens in the Japanese Yen, the company saw a status quo in their turnover due to forex fluctuations. In India, many customers postponed or put a freeze on their projects which did show its repercussions. “During recession in India. most of the life sciences companies postponed or freezed their projects in the last six months. The demand was definitely there but they are  careful in investing in big projects. This also includes Shimadzu‘s customer projects,  especially those who wanted to expand their business,” elaborated Imamichi. However this did not stop the company from launching  five products into the Indian market. In the area of  life science, the company moves forward with the comprehensive development of instruments, reagents, and contract analysis. This development is based mainly on protein analysis technology, which is important for medical treatment and developing pharmaceuticals, and mass DNA sequencing technology, which is important for genetic analysis.  “Despite recession we still continue and would go ahead with our product launches even for this year,” concluded Imamichi.   ]]> <![CDATA[Millipore India expands life science portfolio]]> https://biospectrumindia.com/news/95/2494/millipore-india-expands-life-science-portfolio.html https://biospectrumindia.com/news/95/2494/millipore-india-expands-life-science-portfolio.html Wed, 08 Jul 2009 12:23:00 +0530 Millipore India expands life science portfolio Millipore India, the Bangalore-based India operation of the US-headquartered Millipore Corporation  registered revenue of Rs 160.30 crore for the year 2008-09 as against Rs 173.19 crore the previous financial year. Over the year, Millipore India has expanded the portfolio of life science products considerably. With a range that now includes more than 40,000 products, Millipore is  well placed with innovative solutions for advancing life science in the areas of research, development and production of pharmaceutical products and biologics. Beyond the well established solutions in downstream processing. Millipore has established itself in the upstream area of cell culture and nutrients. Millipore has also been in the forefront in integrating and partnering customers on single use or disposable manufacturing solutions. The Mobius hardware platform and the Mobius range of single use bags, connectors and assemblies have been well received by industry. Millipore solutions in TFF, UFF, chromatography columns and media continue to consolidate their position in the areas of filtration and purification. The country’s first Validation and Process development Lab recently completed five years of world class service for the biopharmaceutical industry. With the introduction of gold standard brands of antibodies and reagents such as Upstate and Chemicon, Indian researchers engaged in research in cardiovascular, immune system, apoptosis, infectious diseases, obesity and diabetes now have access to high quality antibodies. The Lab water division has continued to launch innovative new water purification systems with breakthrough concepts in the production, storage and delivery of pure and ultrapure water. In keeping with its commitment of delivering excellence in quality and in providing customer service and support, Millipore India has made considerable investments in upgrading its manufacturing facilities and service quality systems. The company has the largest team dedicated to technical support and service for life science customers. The EOU manufacturing facility which supplies select products to customers world wide is a part of the Global Supply Chain initiative of Millipore Corporation, USA. The Company has also initiated several programs in the area of sustainability at manufacturing and R&D locations worldwide to conserve, reuse and recycle scarce natural resources and materials. Talking about the company’s future plans, Sudhir Kant, president, Millipore India, said, “Flexible bioprocessing solutions, mycoplasma, rapid microbiology are the new areas. We are also looking at an incubation center. In a couple of months we are launching an advanced training program in which we will teach our customers to manage people and processes together. Disposables will become very popular in the coming years.”  ]]> <![CDATA[Thermo Fisher Scientific moves from strength to strength]]> https://biospectrumindia.com/news/95/2130/thermo-fisher-scientific-moves-from-strength-to-strength.html https://biospectrumindia.com/news/95/2130/thermo-fisher-scientific-moves-from-strength-to-strength.html Wed, 08 Jul 2009 12:22:00 +0530 Thermo Fisher Scientific moves from strength to strength  Thermo Fisher Scientific went through a process of intensive integration of all its division and now intends to heavily invest in manpower, and expand and upgrade facilities in India. Thermo Fisher Scientific which was earlier known in India as Thermo Electron LLS India is a wholly-owned subsidiary of the US-based Thermo Fisher Scientific. It supplies  consumables, and analytical, scientific and laboratory instruments. The company also offers integrated reagents to enhance integration of laboratory workflow solutions. Thermo Fisher Scientific is a result of the merger between Thermo Electron and Fisher Scientific in 2006. In fiscal 2008-09, Thermo Fisher Scientific in India clocked a total sales of Rs 504.89 crore  as against Rs 315.68 crore in fiscal 2007-08. The company’s life science business in India clocked Rs 185.79 crore in 2008-09, making up 37 percent of the overall India revenue.Despite the economic slowdown Thermo Fisher Scientific continued with its  investments in India. “Our growth this year can be attributed to the acquisitions we have made, with the inauguration of the new facilities. Fisher Scientific which is our customer channel group is still hiring people so that we can inculcate new products from the global network into the Indian market. In our scientific instruments division with Chemito Technologies coming on board and the sales board fully integrated, we are still finding new people for recruitment. We also acquired the environmental instruments division which already had a sales force team, who have also been incorporated into our organization,” said Koos van der Steuijt, vice president and general manager, Thermo Fisher Scientific. The Laboratory Products Group saw a double digit growth, with  businesses coming in mainly from the government academic institutions, clinical segments (IVF and blood banks)  and the diagnostics segment. In November last year, Thermo Fisher Scientific opened its $10 million facility in Ahmedabad to support growing demand for biopharma services. The 150,000 sq.ft facility will focus on packaging, global distribution and logistics management of tightly regulated pharmaceutical samples to patients participating in clinical trials across the globe and specifically in India. “We have 250 sales people out here in the market and we need to educate them about our products across divisions in order to become more and more unified while presenting Thermo Fisher Scientific to the customer. Increasingly our customers expect higher service levels from our local organization. We are happy to accomodate that and we feel proud of being challenged and being able to fullfil those needs,” said Koos van der Steuijt. Thermo Fisher Scientific has also been successful in reaching out to even remote areas in India. ]]> <![CDATA[Spinco Biotech focuses on customerization]]> https://biospectrumindia.com/news/95/2592/spinco-biotech-focuses-on-customerization.html https://biospectrumindia.com/news/95/2592/spinco-biotech-focuses-on-customerization.html Wed, 08 Jul 2009 12:15:00 +0530 Spinco Biotech focuses on customerization At Spinco, customerization is the corner stone of its culture since inception in 1981. The company maintains strong commitment and dedication to customer support. Spinco Biotech has been in the business for 28 years and today has a network of  26 offices and 300 employees  across India. The company offers entire range of products under four strategic business units–Chromatography, Life Science, Lyo & Lab Products and Chemistry and Consumable Products – providing end-to-end solutions with technical expertise. Spinco’s chromatography business unit has sold 10,000 Shimadzu HPLCs in India and has announced a celebration around it. The  partnership between Shimadzu and Spinco is 26 years old. Apart from HPLC and mass spectrometers, Spinco offers complete range of detectors including chiral, radioactive, ELSD, electrochemical, MALLS, etc. from one single source. The life science business unit offers comprehensive solutions in genomics, proteomics, cellomics, metabolomics and drug discovery. Advanced instrumentation, consumables and software are supplied through one-stop source from companies such as Affymetrix, GE, Molecular Devices, Shimadzu Biotech, USB, AAPPTec, Wyatt, Golden Helix and Biotique. Spinco entered into an exclusive strategic partnership with GE Healthcare Life Sciences under which customers will have access to a range of products, including, chemicals, membrane and films, electrophoresis units and reagents, sample prep, bioassays and chromatography columns and media products. Also global companies such as US Biologicals (USB), Golden Helix and XRAY Biotique entered into distribution agreement with Spinco. The company’s Lyo & Lab Products (LLP) business unit has been offering  freeze drying expertise from SP Industries, USA (Virtis/FTS/Hull) for over two decades with over 1000 installations. NIR & PAT solutions from FOSS (USA), homogenizers from Kinematica (Switzerland) and Peak Scientific (UK) gas generators are proven workhorses being supplied by this division. Spinchrom Life Sciences , a Spinco group company, offers CBW logistics facility for entire range of molecular biology reagents/kits. This enables door delivery while passing on the customs duty benefits/exemption as applicable to customers. Spinco Genomics Lab at Chennai with a world-class infrastructure provides comprehensive Microarray analysis and application support. The state-of-the-art Affymetrix GeneChip platform is installed with a team of application scientists to serve broad range of novel applications and services. This facility also houses a customer training center.  ]]> <![CDATA[BD forges ahead with patient-centric approach]]> https://biospectrumindia.com/news/95/2257/bd-forges-ahead-with-patient-centric-approach.html https://biospectrumindia.com/news/95/2257/bd-forges-ahead-with-patient-centric-approach.html Wed, 08 Jul 2009 11:45:00 +0530 BD forges ahead with patient-centric approach   With the largest market share in flowcytometry, BD is forging ahead with a patient-centric approach and working in the field of HIV/AIDS monitoring with a focus on stem cell research therapy. Becton Dickinson (BD) is a US-based company that manufactures and sells  a broad range of medical supplies, devices, laboratory equipment and diagnostic products used by healthcare institutions, life science researchers, clinical laboratories, industry and the general public. BD operates in India through a wholly-owned subsidiary, BD India.  BD is focused on improving drug therapy, enhancing the  speed of diagnosing infectious diseases, and advancing research and discovery of new drugs and vaccines. The company  registered  a  revenue of Rs 232 crore for the year 2008-09 as compared to fiscal 2007-08,  recording a growth of 33 percent over the last year when it clocked revenues of Rs178 crore. A growing potential in stem cell research, AIDS monitoring, enhanced government R&D funding with a focus on universities, DST and DBT initiatives to support industries, like SBIRI and NMILTI and a growing demand from CROs have been some of the growth drivers for the company’s business, according to Sunit Trivedi, director, biosciences at BD India. The year also saw a surge in the demand for prefilled syringes from biopharma companies with drug portfolio in oncology and cardiology. It is to be noted that the company is a leader in the flowcytometry segment commanding almost 85 percent of the market in India. This year the company made innovative changes in FACSAria II, used for studies on stem cell therapy and sorting, by adding 375 lasers to it and making it more cost-effective.  BD is also looking at new areas for the application of Influx, a product that was added to the company’s portfolio through its acquisition of Cytopia in 2008. BD’s product range primarily finds its application in experimental stem cell therapy, a new concept in the field of stem cell research, but can also be used in nanobiotech, marine biotech and sterile experimental stem cell therapy. CD4 percentage, a unique product for AIDS monitoring was launched last year that does both the CD4 count and percentage in a single run. Path way 855, another product, was  launched last year for high content cell imaging experiments. BD bagged a major tender for 60 instruments from GoI for AIDS monitoring. Growth was also recorded in high-end sorting. BD is strongly emphasizing education in the field of flowcytometry through its center of excellence for flowcytometry set up in collaboration with the National Centre for Biological Sciences (NCBS) in Bangalore. Talking about plans for the future, Sunit Trivedi  said, “We are  looking towards government partnerships and figuring out how we can work in a  public private partnerships (PPP) model. Some of the focus areas are going to be biosciences, nanotechnology, and AIDS monitoring and immunization.”  ]]> <![CDATA[Waters India emphasizes on technology]]> https://biospectrumindia.com/news/95/1831/waters-india-emphasizes-on-technology.html https://biospectrumindia.com/news/95/1831/waters-india-emphasizes-on-technology.html Wed, 08 Jul 2009 11:41:00 +0530 Waters India emphasizes on technology Waters’ technology breakthroughs and laboratory solutions provide an enduring platform for customer success. Bangalore-based Waters India has recorded revenue of Rs 333.70 crore in fiscal 2008-09 as against Rs 264 crore in fiscal 2007-08. “The company has grown by five percent worldwide. In Asia, the growth is better. While in some areas the business growth was not high but new product launches have helped us. We are very confident to recover in the second half of 2009,” said Venugopalan, president, Waters India. The company is an HPLC leader and holds 35-40 percent market share in this segment and almost 20 percent in mass spectrometry. Waters India is the Indian subsidiary of the publicly traded Waters Corporation  headquartered in Milford, Massachusetts, US. The company employs more than 4,500 with manufacturing facilities located at Milford and Taunton in Massachusetts;  Wexford, Ireland; Singapore and Manchester, England. Waters sells direct in most countries it serves. Waters  creates business advantage for laboratory-dependent organizations by delivering practical and sustainable innovation to enable significant advancements in such areas as healthcare delivery, environmental management, food safety, and water quality worldwide. Pioneering a connected portfolio of separations science, laboratory information management, mass spectrometry and thermal analysis, Waters technology breakthroughs and laboratory solutions provide an enduring platform for customer success. Waters Ultra Performance LC, high performance liquid chromatography (HPLC), mass spectrometry (MS), chemistry, software and services are the market leaders in its respective segments. The year 2009 marks Waters’ 51st year of analytical instrument industry innovation. While the company offers a broad array of technologies, it still maintains platform products in four key areas: instruments, chemistries, software, and services. Its best known brands are Acquity UPLC systems, Acquity UPLC BEH, XBridge, Sunfire, Symmetry, Atlantis and XTerra columns for analytical to preparative scale chromatography; Oasis solid phase extraction (SPE) products; Alliance HPLC and HPLC/MS Systems; Empower, MassLynx, NuGenesis SDMS, eLab Notebook software, Xevo QTof MS, Xevo TQ MS, Synapt G2, eAlliance, the premier line of mass spectrometers, and Waters global   services and support programs: AssetCARE, Relocation Services and Connections Insight programs. The company currently employs 200 people in India and will increase it by another 20 this year. The company reports close to zero attrition. ]]> <![CDATA[Good show!]]> https://biospectrumindia.com/news/95/2466/good-show.html https://biospectrumindia.com/news/95/2466/good-show.html Wed, 08 Jul 2009 11:30:00 +0530 Good show! In spite of slowdown and swine flu scare The ninth edition of Bangalore BIO, India’s biggest biotechnology show hit the right cord with its theme “Biotechnology Beyond Boundaries—the Promise of India.” The three-day event (June18-20, 2009) comprised Multi-Track Conferences, International Trade Show, BioPartnering, CEO Conclave, Bio IP Zone, Bio Excellence Award and a host of other events. The objective clearly was to promote entrepreneurship. Bangalore BIO continued its growth track in spite of various challenges due to the global economic slowdown. This year more than 700 delegates from across the globe participated in the six focused tracks and 22 conference sessions. More than 100 Indian and international speakers participated in these conference sessions. The event also witnessed over 400 biotech, pharma and biosupplier companies exploring business opportunities. The 2009 exhibition attracted over 110 national and international organizations showcasing their innovation. There were 15 organizations from Germany, apart from exhibitors from UK, Australia, Singapore, France, Spain, Italy, Holland, US, Canada, Cuba, Malaysia, Japan, Iran and UAE. BioPartnering, the first of its kind initiative by the event organizers and Technology Vision Group (TVG), of the Government of Karnataka got a resounding response. More than 400 business meetings were conducted through this initiative. The show was inaugurated by Prithviraj Chavan, India’s newly-appointed minister of science and technology, who took charge in May 2009. He came. He saw. He inspired. Dr Richard J Roberts, “Nobel Laureate” addressed the plenary session at Bangalore BIO 2009—India’s largest biotech show. His anecdote-filled talk essentially showcased the potential of biotech to the industry and emphasized that the future is biotechnology. There is no better person than Dr Roberts to bust the commonly held (mis) conceptions on the horrors of GM food, and other such political considerations that science and scientists have to often contend with. He bagged the Nobel Prize for Physiology in 1993, for discovery of introns in eukaryotic DNA and the mechanism of gene-splicing. He showed the world that genes can indeed be split. So, when a scientist like him says, plant breeding is a form of genetic modification and that introducing one gene about which you know a lot is comparatively much lesser risk than cross-breeding at random with little knowledge—you have to believe it. Dr Roberts, who also leads the cutting-edge scientific work at New England BioLabs in the US also stressed on the importance of taking advantage of serendipity in the course of scientific research. Keeping an open mind and looking for solutions is what really drives science, he stated recounting how BioLabs decoded the genome of filariasis bug and discovered that it had not one but three genomes—chromosomal, mitrochondrial and of another bug called Wolbachia, which is actually critical to the survival of the filariasis bug. This was a very important finding given that according to WHO, more than a billion people across 80 countries are at risk of Filariasis. Close to 150 million people are already infected with this disease that causes chronic suffering and disability. One-third of the people infected with the disease live in India, one third are in Africa and most of the remainder are in South Asia, the Pacific and the Americas. “There is so much of the unknown in life mechanisms, that a lot of Nobel Prizes are yet to be won in biotechnology,” quipped Dr Roberts. Looking ahead beyond 2010 Dr Roberts elaborated that the areas that one can focus on include GM foods, bioenergy, synthetic biology, stem cells, and personalized medicine. He also advised, thinking “small” is good. As far as solutions go there is no one-size-fits- all and innovation comes in small packages, often.  Leaders of the Indian Biotech Industry and CSIR discussed the ways to gear up the Indian biotech industry to face the global challenges. Industry leaders mulled over “The strategies for Indian Biotech in the new economic world order.” When ‘melt-down’ is the global reality in every sector, Indian biotech industry holds lot of promise to cater to the needs of food and health for the people, according to the panelists. When India is upgrading itself, there is an immediate need to fine tune HR and other resources. India is still facing shortage of highly motivated scientists with global outlook. Finishing schools on the lines of IT industry are creating more awareness towards the IPR environment, which is the need of the hour. India has unparalleled opportunity in commercializing IPRs. Most of the hurdles in India in realizing the true potential of IPs are self imposed and avoidable. There should be a change in seeing the science from technology perspective to commerce perspective. Experience of the people who are filing IPRs is not up to the mark. Industry should build capacity to generate more IPs from business point of view than scientists’ perspective. The walls between IP management offices and scientists should go. Increasing medical insurance coverage, growing economy and per capita income, huge number of disease population, and increasing labs and CROs make India a potential market for in vitro diagnostics (IVDs).  Indigenous manufacturing of raw materials, automation of production processes, and use of lab-on-chip technology to bring multiple markers into a single platform will help reduce the cost of IVD in India. India is renowned for its generics industry but if India has to gain further reputation as a biopharma powerhouse, it has to start innovating. India’s strength lies in its numerous scientists who can develop amazing array of drugs, if given a chance. Srikumar Suryanarayanan, direct general, ABLE: “In order to catch up with the market and shorten lab-to-market cycle, Indian CROs should not settle for lesser standards that are normally acceptable to Indian levels. They should think of meeting the stringent standards in the world, if they really want to compete in the International markets. Coming to agri biotech, the benefits are more local and immediate. So we should take forward the success that we have seen to food crops.” Dr Kiran Mazumdar Shaw, chairperson, Karnataka’s Vision Group on Biotechnology & CMD Biocon: “Chemical genetics market mind-set has to be changed to biological genetics mind-set, as the development path of these two are different. Emerging marketing strategy to regulated market strategy is the need of the hour, as proprietary technologies under strict regulatory regime can only enter global market. Dr Rajat Goyal, country director, International AIDS Vaccine Initiative: “The lack of availability of vaccines, R&D investment, regulatory responsiveness and public interest as the main reasons for the lack of novel vaccine development in India. Philips Mendes, Innovation Law, Australia: “Licensor and Licensee need to focus more on their respective interests instead of positions. Never dive into a negotiation, you may deny many opportunities to prepare thoroughly. Information shared and gathered plays crucial role in licensing and true value realization by both the parties.” Dr PM Murali, managing director of Evolva: “With drug costs escalating every year,  there’s every possibility of sub-$1billion drug coming out of India in nanotechnology.” Call for government support The Indian biotechnology industry wants the government to recognize the  benefits that have come from this sector to date and the potential of this sector to positively impact on the economy, environment, agriculture and healthcare, and insists that further investment will deliver benefits in a much higher level. Prithviraj Chavan, the minister of state (independent charge) for science and technology, during his visit at the ninth edition of Bangalore Bio had an exclusive interaction with the biotechnology industry leaders during a closed door roundtable.  The roundtable, organized by Association of Biotechnology Led Enterprises (ABLE), was convened to gather inputs from diverse segments of the biotechnology industry as to the current issues concerning it, with a view to determining forward recommendations. The discussion had the who’s who of the Indian biotech industry—Dr Shrikumar Suryanarayan, DG, ABLE; Dr Kiran Mazumdar Shaw, CMD, Biocon; Dr Villoo Morawala Patell, CMD, Avesthagen; Dr Vijay Chandru, MD, Strand Life Sciences;  Anuradha Acharya, CEO, Ocimum Biosolutions; Dr KK Narayanan, MD, Metahelix Life sciences; PM Murali, CEO, Evolva Biotech; Pramod Chaudhary, CEO, Praj Industries;  Sarath Naru, MD, Venture East India Fund Advisors; Dr Samir Brahmachari, DG, CSIR; Arvind Jaanu, MD, KBITS; and Narayanan Suresh, group editor, BioSpectrum. The primary focus of the discussion at the industry roundtable was on HR issues and mechanisms to reduce hurdles in the regulatory system. The deliberation that followed was multidimensional in the sense that the view points of all the segments—biopharma, bioagri, bioinformatics, biofuel, services, venture capital companies were sought. Shrikumar Suryanarayan said, “There is an urgent need for world class institutions. The institutes should strengthen basic sciences like immunology, cell biology, recombinant technology, and government can play a significant role in this space.”  Dr Kiran Mazumdar Shaw said, “The government should take serious steps in attracting NRI scientists. A proper mechanism should be employed to attract them here.”  The lack of skilled manpower was predicted to slow down the growth of this industry, which was otherwise racing ahead at 30 percent growth in the past three years and at 18 percent this year. The other issue raised at the industry roundtable was on the structure and efficiency of the Indian government policies and the regulatory system. Dr  Shaw expressed that the Indian policies should be more R&D enabling and business enabling. She further said that all the people in the regulatory system are not that knowledgeable to create an innovative ecosystem.” The DST should stress on local innovative solutions. Biotech being a high risk business it requires better financial facilitation and incentives—a must for innovation and entrepreneurship, she added. Highlighting the issues facing the services sector, Anuradha Acharya said, “We face a lot of problems in running a services company. More than hundred shipments are done every day which results in plenty of paper works. The process should be made more simple and smooth. Also, the duties and taxes are very high.” While Dr Villoo Morawala-Patell agreed to the point, she brought to the table another basic problem, about the very structure of the Indian stock market listing, She suggested that the government should change the financial model to allow research focused companies which were yet to reach large scale revenues and also to list on the stock exchanges. It should let the people decide their investment choice than the financial institutions. Narayanan Suresh, group editor, BioSpectrum, highlighted the incoherent voices emerging from within the government and regulators about the importance of genetically modified (GM) food crops. He urged the need for the scientific ministries and experts to stand up and speak their mind on the importance of biotechnology. He pointed out that the benefits of India’s biotech industry were mostly enjoyed by foreigners as two-thirds of the industry revenue came from experts. He stressed  the need to increase access to affordable medicare to Indian citizens and called for schemes which include biotech vaccines and drugs in the National Immunization Program. Countries like Bangladesh have included Hepatitis B and other important vaccines in the national program, while India has ignored these India-made products that are used widely in over 100 other countries. n BioSpectrum Bureau ]]> <![CDATA[Single-use systems gaining popularity in bioprocessing]]> https://biospectrumindia.com/news/95/2408/single-use-systems-gaining-popularity-in-bioprocessing.html https://biospectrumindia.com/news/95/2408/single-use-systems-gaining-popularity-in-bioprocessing.html Wed, 08 Jul 2009 11:25:00 +0530 Single-use systems gaining popularity in bioprocessing G Somasundaram is the manager - technology support at Millipore India. Manufacturing plants must be able to add new products to the mix, rapidly convert processes, and quickly make operational adjustments as needed. These changeovers must be executed while meeting required safety, time-to-market and efficiency goals. Many manufacturers are implanting single-use systems to meet these deliverables, which are gaining ground in biopharmaceutical manufacturing facilities in India as the advantages of disposable process equipment over traditional stainless steel process equipment become obvious. Indian biopharmaceutical companies are now using disposable assemblies at an ever increasing rate. Single-use technologies are becoming available for an increasing number and range of applications, with all its inherent advantages over traditional equipment.  Early adoption of single-use process equipment depends on the manufacturing environments that require bioprocessing flexibility such as in the development and manufacture of biologics. Particularly when the unit needs to quickly accommodate new products and process modifications. Speedy installation, startup and flexibility in switching products are the obvious advantages for speed-to-market. Under such conditions, manufacturers of oncology drugs and other high value biologics are finding  traditional stainless steel equipment like storage tanks and transfer lines cumbersome because of the amount of time taken in installing, starting, cleaning, sterilizing and validating them. Another significant advantage seen is the reduced risks of product contamination. Instances of integrating single use solutions i.e plastics and existing steel equipment, as in hybrid systems are also very prevalent in the biotech industry as companies seek to protect their capital investments in traditional systems. In some cases, manufacturers seeking to ensure product safety by eliminating the risks of product cross contamination, have moved to disposable systems completely or incorporated hybrid solutions at critical stages in their production processes. Single-use solutions have proved useful in facilities requiring extensive revamping in terms of: Reducing the risk of cross contamination to a minimum. No product carryover validation study. Reducing the risk of microbial contamination by limiting the use of valves and manifolds traditionally used for transport of product and buffers. Flexibility of movement from one product to another i.e. no equipment decontamination. Minimum validation prior to start up. Mobius mixing systems have demonstrated that by reducing downtime for cleaning validation and process engineering, manufacturers can increase production capacity in multi-product facilities. Reduced downtime for validation, cleaning-in-place (CIP) and sterilization-in-place (SIP) automatically increase the number of days the production line is available for manufacturing every month. Mobius pre-sterilized bags have proved handy for sterile applications like sampling, transfers and storage. NovaSeal sealing technology is a boon to securely crimp and cut the disposable assembly into two sterile fluid paths. Sterile capsules that are gamma-irradiated, available in a wide range of media, membranes and sizes for flexibility, make scale-up easy while minimizing hold-up volumes and other production losses. Perhaps, one of the biggest concern areas in traditional processes has been that of quick and contamination-free installation and cleaning of fluid pathways. Piping bends, joints and on-line sampling ports are difficult to install and clean. Single-use Lynx connectors allow the integration of steamable hard-piped process equipment with disposable sterile fluid paths. This results in economical, easy and reliable sterile connections for secure transfer or sampling of sterile fluids. Early adopters of this technology are realizing the savings accruing from quicker installation as compared to stainless steel, the relatively lower capital and operating costs and the tremendous savings from lower utilities demand, particularly for clean steam and water for injection (WFI). There are significant savings from reduced labor and time spent on CIP and SIP. While there are many suppliers of single-use solutions, the crux of the problem is to get integrators and not just vendors of different components. Companies such as Millipore address this need by partnering the industry with the widest range of integrated solutions for mixing/compounding, storage/holding, filtration, sterile connections, sterile transfers and filling including the critical expertise in validation. Validation of single-use solutions demands a different kind of validation. Validation here, requires expertise on product compatibility, leachables and extractables testing. The advantage of films from companies such as Millipore is that product contact layers are kept the same from sampling to filling systems, hence single product contact validation study is sufficient. A new innovation in the industry in the form of Mobius FlexReady combines single-use assemblies (Flexware), innovative separation devices, and process-ready hardware systems. The platform can be wheeled quickly to wherever the process requires it and can be quickly and safely adapted to the process requirements. The disposable single-use technology has arrived in India. Particularly in manufacturing environments (CRAMS) where speed-to-market, product safety for regulated markets and flexibility are key concerns. More so in the manufacture and development of biologics and anti-cancer drugs. ]]> <![CDATA[Changing HPLC trends in today's lean laboratories]]> https://biospectrumindia.com/news/95/2615/changing-hplc-trends-in-todays-lean-laboratories.html https://biospectrumindia.com/news/95/2615/changing-hplc-trends-in-todays-lean-laboratories.html Wed, 08 Jul 2009 11:19:00 +0530 Changing HPLC trends in today’s lean laboratories Tanay Waingankar is the marketing manager - life science industry at Agilent Technologies, India. High pressure liquid chromatography (HPLC) has for many years been a routine analytical technique built on robust column technology and reliable instrumentation. Each analytical laboratory has accumulated dozens, if not hundreds, of methods typically taking 20–60 minutes or even longer. However, laboratory managers have precious little time and resources to update their methods to assure that they are keeping pace with improvements in technology. At the same time, they are continuously being asked to accomplish more and obtain better results without increasing the size of the laboratory staff. Column technologies and improvements to HPLC system components can help to realize this goal by enabling laboratories to meet these demands. Conscious decisions are required while tuning methodologies that best take advantage of the technological development using existing instruments and while planning investments for new instrumentation. A plan to upgrade the laboratory’s HPLC capabilities in a phased, stepwise fashion can help to use budgets and resources most effectively. For example, column packings that utilize a unique superficially porous particle technology made with a layer of porous silica on a solid core of silica. Operating at 40–50 percent less pressure than conventional high-resolution columns, they can provide the separation efficiency of a sub-2 mm particle, without the need to upgrade to a high-pressure system. These columns can provide even more peak capacity on the new high-pressure LC and LC–MS systems. Larger pore sizes and standard frits reduce the frequency of column clogging and minimize downtime. Improvements in instrumentation like UHPLC technology are also being made on a continuous basis, and they can be incorporated into existing labs. Adopting all of these advances in technology in a rational, measured way can provide higher quality results and thus assure the excellence and safety of products whose quality is controlled using LC. HPLC has been traditionally one of the strongest and widely used analytical techniques since past several decades. The advent of liquid chromatography happened in the early 1900s and since then this technology has undergone manifold changes in size, performance and flexibility. Be it a pharmaceutical manufacturer or a lab testing food quality, all such industries see a strong need of this technique in their analytical testing. The need for innovation has brought in lot of changes and automation. Standard LCs with multiple detection techniques are seeing growing application suitability. Mass spectrometry has seen a growth in its usage as an advanced detection technique and hence the need for a good front end has fueled the need for innovation in LC technology. HPLC is nearing the state of a mature technique as the technical advances are slowing down and with the entry of Ultra High Pressure Liquid Chromatography (UHPLC), an extension of HPLC, into the realm of high pressure operation (> conventional 400 bar pressures) that affords advantages in terms of speed for shorter columns and improved resolution for longer columns. However, the higher pressures can put greater demands on instrumentation, require more careful practices regarding lab and instrument hygiene, and cause some unintentional effects due to changes in fundamental phenomena such as solvent compressibility, retention factor behavior and so on. In 2003, Agilent Technologies was the first company that took a lead in venturing into a new arena by reducing the column particle size from the traditional 5 um to 1.8 um Rapid Resolution High Throughput (RRHT) columns. Later on Waters introduced Acquity UPLC system and 1.7 um columns. Since then over the last five years over 10 UHPLC systems have been introduced into the market and every vendor claims superior performance on some or the other aspect.  Lately, the 1290 Infinity LC from Agilent Technologies is the newest UHPLC to hit the market that offers highest power range as well as the first system that delivers the foundations for method transferability from and to any UHPLC and HPLC systems. The trend to speed up separations (more specifically for complex samples), has been and will continue to be a major growth engine for the technique in years to come. Part of the reason for the continuation of this trend is that businesses will focus on advancements in technology and methods to maintain profit margins in an economic climate that is dominated by increasing competition. Thus, the emphasis will be on increasing throughput, which can be obtained by the use of smaller particles, often in combination with higher operating pressures, which in turn will result in additional purchases of UHPLC or UHPLC-like instruments. Market research has shown an annual growth rate of between 20 percent and 30 percent for UHPLC systems Speed of analysis and low solvent usage tends to be the most compelling reasons to convert from HPLC methods to UHPLC.  ]]> <![CDATA[India: Rise of a diagnostics superpower]]> https://biospectrumindia.com/news/95/7897/india-rise-of-a-diagnostics-superpower.html https://biospectrumindia.com/news/95/7897/india-rise-of-a-diagnostics-superpower.html Wed, 08 Jul 2009 11:02:00 +0530 India: Rise of a diagnostics superpower Diagnostic market has been growing at 15-20 percent and by all indications shall continue to grow for another 10 years at this rate. Increasing personal wealth and awareness about health is pushing Indians into seeking better medical options. Today hospitals and diagnostic centers across the country are armed with the best in class medical and diagnostic devices. Companies that offer these devices are increasing their investments and product portfolio in the country—an unlikely scenario at the start of this decade but a familiar situation across India. Various diagnostics devices manufacturers who skipped India to find better markets elsewhere today find India a red hot market in which to do business and are finalizing both business and manufacturing deals anticipating huge uptake for their devices. They should. India is home to one-sixth of humanity, 30 percent of population is below the age of 25, increasing government expenditure on healthcare and even expanding medical insurance coverage is helping people to care more about their health. The number of tests conducted in the last decade has doubled from 180 million to more than 425 million. There are over 12,000 hospitals and 15,000 diagnostic laboratories in the country that utilize large volumes of diagnostics. Although India hasn’t become a full-fledged manufacturing hub for medical devices, things are changing. There are many local companies that produce diagnostic kits, reagents and kits for blood grouping, serology, clinical chemistry, pregnancy detection, HIV detection and other rapid tests that are accepted globally and imports of such products in finished form is almost negligible. According to Netscribes, the medical diagnostics market is just 10 percent of the healthcare sector’s revenues and was estimated to be about  Rs 37,900 crore in 2008. In India, 60-70 percent of medical treatments are based on laboratory diagnostics tests. Markets for medical devices booming In a recent report for the Department of Pharmaceuticals, Ahmedabad-based National Institute of Pharmaceutical Education and Research (NIPER) said the medical devices supplies market in India will be approximately $1.70 billion by 2010— growing at 23 percent annually. Currently, the market for medical devices supply is Rs 5,750 crore or $1.19 billion. In its report NIPER said diagnostic kits are a fast growing segment of the entire devices market growing at 30 percent, annually. With over 50 companies vying for business, the business will only grow.  However, experts say it is difficult to determine the exact size of the market in India, as the diagnostic market is highly fragmented as it involves different segments such as home segment, urine chemistry, diagnostic kits, and reagents. The entire market for diagnostic kits and urine chemistry will be about Rs 275 crore, discounting the cheap unbranded Chinese kits that are available in plenty in the grey market. Another area of growth is the in-vitro diagnostic (IVD) market that includes diagnostic test services and diagnostic products. This market has grown substantially in the last five years making India one of the important business areas for IVD. The market however is dominated by the MNCs, who between themselves have cornered 65 percent of the market. Another business that has seen growth is market for clinical chemistry which is approximately Rs 490 crore. Instruments market is estimated at Rs 185 crore while the reagents market is at Rs 305 crore. The reagent market is further divided into “closed systems” at Rs 85 crore and the actual served open market at Rs 220 crore. The leading players in this segment include Transasia Bio-medicals which was ranked as the top IVD company in India by McEvoy & Farmer, a US-based experts on IVD markets. The other major players in this group are Roche Diagnostics, J Mitra, Johnson & Johnson, Beckman Coulter, Trivitron, Accurex, Tulip/Crest, Bayer-Siemens, Agappe, Randox, Span, Wipro Biomed, Merck, Ranbaxy, NPIL-DiaSyS. Apart from these, there are 30 other smaller players operating in this market segment. Opportunities galore According to international reports, the Indian healthcare sector is currently valued at $34 billion and by 2012, it will be valued at approximately $40 billion and out of this market, the diagnostic and pathology market is around 2 percent. The diagnostic market has been growing at 15-20 percent and by all indications shall continue to grow for another 10 years at this rate. Diagnostic market includes diagnostic test services market and diagnostic products and instruments market. Diagnostics and pathology lab test services market in India holds 44 percent of the medical devices and diagnostics market, valued at Rs 12,587 crore in 2007. According to Cygnus Business Consulting and Research, Indian diagnostic and pathological labs test services market is valued at Rs 5,590 crore (2007) and is estimated to reach Rs 13,900 crore by 2012. Increasing health consciousness and preventive care have changed the landscape of healthcare services market. Whether it is wellness checkups, preventive care checkups or insurance-related checkups, diagnostics and pathology laboratories are growing significantly, fueled by the growth in outsourcing diagnostics tests and clinical research. The Indian diagnostic and pathological labs test services market was valued at Rs 6,687 crore in 2008, says the Cygnus report. There are about 40,000-50,000 pathology labs spread across the country with less than 100 having accreditation. Out of these only a few labs are operating as referral centers and about 1,000 labs are automated. The major players in diagnostics and pathological test labs market are Metropolis, Religare SRL Diagnostics, Dr Lal’s Pathology, Piramal Diagnostics (formerly Wellspring), Thyrocare and Anand Labs. Lifestyle diseases make a large market India has the largest number of people suffering from diabetes while hypertension, respiratory diseases and obesity are increasing as lifestyle changes. This has led to the growth of consumer home-use medical device markets. As per industry forecasts, personal use device  segment will reach over $5 billion by 2011. India is also fast emerging as the diagnostic capital of the world, currently there are about 40.9 million Indians suffering from diabetes. But the concept of Self Monitoring Blood Sugar (SMBG) is still not well-known in India as compared to the West. In India a meager 0.3 percent of diabetics use SMBG as opposed to almost 22 per cent in developed countries. Lack of awareness regarding complication of diabetes and benefits of regular monitoring are key factors for this. Imports constitute over 50 percent of this market. Most imported products have high gross margins. Currently, the high value imported products include cancer diagnostic, polymerase chain reaction technologies among others. However, the market is becoming increasingly competitive due to low entry barriers, relaxed laws, increasing competition and users. The duty exemption for diagnostic kits used to detect life threatening diseases is another area of contention. NIPER noted that the duty waiver continues to only apply to basic techniques that are increasingly replaced by newer and more precise methods like the polymerase chain reaction (PCR) test. At present only tests like the ELISA and CLIA enjoy the duty waiver while the PCR kits attracts 37 percent. Customs duty in spite of applications in the diagnosis of diseases like TB, hepatitis or bird flu, increase the cost of tests done using the advanced technique. These budgetary tax measures coupled with an already anomalous customs tariff structure are expected to escalate the cost of treatments and burden the patients and ultimately constraint the delivery of modern healthcare, the report noted. As a measure to tackle the increasing duty structure and dependency on imports, Indian companies are looking forward to having alliances with foreign companies either to import and distribute their products in the Indian territory or become licensed manufacturers and distributors of the foreign companies. For example; Japan-based Arkray, has entered into a 49:51 joint venture with Piramal Healthcare and formed Arkray Piramal Medical to market diagnostic products, mainly SMBG (Self Monitoring Blood Glucose System) in the Indian market. Arkray Piramal is currently looking at strengthening its position in the SMBG space. Investments India as a major bioindustry and IVD manufacturer needs to invest in dedicated research and development to boost the delivery of increasingly sophisticated equipments and quality kits. Steps need to be taken to cross the current chasm to fulfill responsibilities to doctors and patients in meeting and exceeding their needs for reliable, affordable and innovative medical diagnostic systems. Looking at the opportunity and growth of the market, local companies are now investing on R&D and developing a range of kits for the local market. However, there are a few hi-tech products like Elisa, PCR, a few cancer markers and many other products for which there are very few manufacturers in the country. This area is also developing very fast. Xcyton, had recently launched a PCR-based diagnostic kit for eye infections. The project was supported by the Ministry of Science and Technology, and was a collaborative effort involving research institutions like Shankara Netralaya, LVP Eye Institute, the Centre for Cellular and Molecular Biology, and the All Indian Institute of Medical Sciences. The level of R&D spending in the medical device and diagnostics industry, as a percentage of its sales, has been consistently increasing from 5.4 percent in 1990, to 8.4 percent in 1995, to 12.9 percent post 2000, says NIPER. NIPER has asked the government for creation of more academic centers to meet the technological and regulatory demands; interdisciplinary and combinatory research projects; testing facility for devices and pre-clinical and clinical studies for medical devices as some of the measures to assist the sector. The emerging industry structure is headed towards providing healthcare services as an integrated comprehensive package rather than the traditional concept of providing healthcare infrastructure and reactive medical care. Growing health consciousness among middle and high-income families in India is heralding a new business opportunity—preventive healthcare. This has shifted focus from in-patient treatment to a regular preventive health check. Corporate companies offer annual health check for their employees; insurance companies conduct pre-insurance policy check; and self paid health checks also give out a potential business opportunity. Private equity (PE) and venture capital (VC) investors are looking to step up the pace of investments in the healthcare sector in India. In the recent past though, specialty PE firms have emerged to invest exclusively in this segment. Evolvence India LS, India Ventures and Sabre Capital’s Spring Healthcare fund are some PE funds in this category. According to Venture Intelligence, ‘There are very few corporate hospitals and PE and VC funds see this as an opportunity to bring smaller hospitals together to scale-up.’  In July 2008, Mauritius-based private equity fund New York Life Investment Management and Jacob Ballas India Fund invested $22 million in Mumbai-based Themis Labs. In February this year, India Venture invested $18 million in Tamil Nadu-based Kavery Medical while IFC invested $30 million in Max India. Sabre Capital has a $100 million fund focused on investing in mid-size existing hospitals or in start-ups. ChrysCapital, which focuses on the pharmaceutical sector, is looking at opportunities in the healthcare space especially in hospitals, medical diagnostics and devices. It may invest anywhere between $30-300 million with a long-term view of 5-10 years. Venture Intelligence noted that over 42 percent of PE and VC investors felt there was a strong opportunity to tap the market for healthcare services in semi-urban and rural areas. The investors also identified diagnostic services, medical devices/equipment, hospital chains and wellness products and services as favorite sectors for investments. The emerging trend in the healthcare sector and initiatives mooted by the government and interests from the PE/VC community will boost the upcoming and growing diagnostic market in India. Narayan Kulkarni ]]> <![CDATA[Metahelix gets GEAC nod for cry1C gene, 2 Bt cotton hybrids]]> https://biospectrumindia.com/news/95/2302/metahelix-gets-geac-nod-for-cry1c-gene-2-bt-cotton-hybrids.html https://biospectrumindia.com/news/95/2302/metahelix-gets-geac-nod-for-cry1c-gene-2-bt-cotton-hybrids.html Wed, 08 Jul 2009 10:56:00 +0530 Metahelix gets GEAC nod for cry1C gene, 2 Bt cotton hybrids One of India’s promising bioagri startups, Metahelix Life Sciences has crossed a major entrepreneurial hurdle with the regulator approving its two Bt cotton hybrids with the novel cry1C gene, making it the first Indian private company to develop a commercial gene on its own. An exclusive report by BioSpectrum Editor, Narayanan Suresh. The Bt cotton farmers in the central and southern Indian states will be spoilt for choice soon. Two more Bt cotton hybrids, which has enhanced capabilities to fight two major pests, bollworm and lepidopteran insect pests, developed by Bangalore-based Metahelix Life Sciences, will be available in the marketplace. The biotech regulator, the Genetic Engineering Approval Committee (GEAC) has approved the commercial cultivation of the Bt cotton hybrids MH 5125 Bt and MH 5174 Bt, on June 1, 2009. The decision to approve these two Bt cotton hybrids which incorporate a synthetic cry1C gene was taken at the May 13, 2009 meeting of GEAC. In this novel method, the single gene, cry1C, will provide protection against two major pests (bollworm and spodoptera) which account for more than 60 percent of the pests that damage this crop. “The GEAC approval is a major milestone for Metahelix which has become the first Indian  private company to develop a commercial cry1C gene on its own,” said a visibly excited KK Narayanan, co-founder and MD of Metahelix. The company was founded in July 2001 by a group of enthusiastic agricultural scientists, Narayanan and Gautham Nadig, with two other bioagri industry colleagues with the singular objective of developing an Indian Bt gene on its own. “We had done extensive due diligence on the capabilities of this cry1C gene before we started on our entrepreneurial journey. Metahelix has been considered to be one of the most promising biotech seed company and Narayanan was chosen the 2nd BioSpectrum Entrepreneur of the Year Award for 2004, by the BioSpectrun Awards Jury due to the company unique business model which placed a premium on its ability to develop a pioneering product. BioSpectrum had then described Metahelix as “India’s Own Monsanto.” This confidence in the company’s capabilities has now been justified. Over 100 Bt cotton hybrids are now available in the Indian market place. The most dominant ones which fights the major cotton pest, bollworm using the cry1Ac gene (Bollgard-1) and Bollagard-2 which has the cry2Ac gene to fight bollworm and spodeptera, was developed by American seed giant, Monsanto. These two genes have been licensed by over a dozen Indian seed companies and incorporated into their cotton hybrids. The second set of Bt cotton seeds are made available in the country by Nath Seeds using  cry1Ac genes licensed from a Chinese seed company. The third set of Bt cotton hybrids are distributed by JK Agri Genetics using the cry1Ac genes developed by a team of scientists at the Indian Institute of Technology, Kharagpur, West Bengal, under a public-private partnership arrangement. Regulatory approval has been given to the two Bt cotton hybrids by Metahelix to be cultivated in the states of Gujarat, Madhya Pradesh, Maharashtra, Andhra Pradesh and Karnataka. The cry1C gene (called event 9124) of Metahelix has been approved and now could be used for experimental trials in other crops. Based on the performance of the new Bt cotton varieties, monitored for three years, Metahelix will be in a position to seek approval for commercial use with other crops like tomato, rice, etc. Proud of their path breaking achievements, Narayanan and his Metahelix team are moving into the market cautiously. The cotton planting season starts in April every year and most of the plantings for the current season have already been done. So Metahelix is not in  hurry to rush into the market. “We have started giving samples of the Bt hybrids to a large number of farmers now itself for demonstration purposes. Some sales will also happen. We want to create awareness among the farmers about our hybrids and also let the performance of these hybrids speak for itself,” Narayanan said. “The two transgenic cotton hybrids have been tested extensively in the last two years as part of the regulatory process. The transgenic cotton seeds were tested in various fields of the Indian Council of Agricultural Research (ICAR) and the data has been evaluated by the regulators. In addition, the seeds were tested in the experimental fields of six state agricultural universities (SAUs) in Karnataka, Tamil Nadu, Gujarat, Maharashtra and Andhra Pradesh. These were large scale trials in one acre or more and was done in nine locations,” Narayanan said.  Almost all the transgenic hybrids of Metahelix gave excellent performance except for one set grown in an experimental farm in Karnataka, according to the data provided to the regulator. One of the test plots in Karnataka did not give good results compared to that in other areas, due to delayed sowing and  an unrelated bug attack. After bollworm which accounts for nearly 60 percent of a farmer’s pesticide input costs, spodoptera species whose larvae eats the cotton plant’s leaves extensively is the next major threat to the crop. For every acre, a farmer spends on an average of Rs 1,000 or more on pesticide sprays to keep the infestation under control. In addition, for every acre a farmer will spend another Rs 2,000 to keep the bollworms away. With the use of a hybrid which has the genetically modified traits to kill both these major pests, a farmer will save substantial amounts of the costs on pesticides. “ We were extremely confident about the success of the cry1C gene. We had identified the nucleotide sequence of the gene which was codon optimized for the best expression of the proteins against the spodoptera pest,” explained Tomal Dattaroy, a senior scientist who led the development efforts at Metahelix. Like the other transgenic cotton hybrids in the market, the two Bt cotton hybrids from Metahelix too will have to be planted with “refuge” lines of non-Bt cotton  in 20 percent of the sown area in each plot, according to the GEAC directive. A farmer could also plant two to three rows of pigeon pea equivalent to 10 percent of the total sown area as an alternative, according to the GEAC approval order given to Metahelix. “ We have done extensive biosafety studies on the gene and the hybrids,“ asserted Narayanan. The entire set of biosafety data related to the cry1C and the two Bt cotton hybrids are available for public scrutiny at an exclusive website which is the resource bank for information related to all genetically-modified crops. One more Indian bioagri company has demonstrated the capability to handle the complex development process related to genetically modified crops. Narayanan and his team efforts will also bring a smile to the angel investor, Nadathur Holdings, run by one of the co-founders of Infosys, NS Raghavan, who funded the start-up to the tune of of Rs 6.5 crore. Kotak Mahindra Private Equity Fund chipped in with another Rs 5 crore. Recently Nadathur Holdings and Kotak Mahindra have jointly invested another tranche of Rs 16 crore in Metahelix. Narayanan is a relieved man these days as his bet on cry1C gene has come off. The perseverance with which the team tackled the complex task without any outside support has been rewarded. Now the investors too could be sure about their exit route and Metahelix will be primed for a public offering in two-three years. Dhaanya Seeds, a fully-owned subsidiary of Metahelix, has already set up an efficient marketing and distribution network for hybrid seeds. This network will come in handy when full-scale commercial offerings start in the 2010 cotton season. Bangalore’s growing biotech cluster will have one more show piece company in Metahelix in the coming months. ]]> <![CDATA[Year of consolidation]]> https://biospectrumindia.com/news/95/1285/year-of-consolidation.html https://biospectrumindia.com/news/95/1285/year-of-consolidation.html Wed, 08 Jul 2009 10:48:00 +0530 Year of consolidation With the adoption of right business model, strategy and a wave of consolidations the global biotech industry continues to register good growth and gears up for competing in the new global marketplace. The aggregate value of biotechnology drugs are set to grow 56 percent between 2008 and 2014, from $108 billion to $169 billion. This contrasts sharply with conventional chemistry drugs, which are projected to grow 5.6 percent in aggregate, with total sales forecast to be $565 billion in 2014 versus 2008 sales of $535 billion. According to market research firm EvaluatePharma, biotechnology drugs will account for 50 percent of the top 100 drug sales by 2014, up from just 28 percent in 2008. This has offered hope for the future prospects of the industry, as the first generation of biotechnology drugs to reach commercial maturity are unlikely to be subjected to the same intensive generic competition as small molecule drugs. This has certainly provided biotechnology-focused companies with a more stable base from which to build long-term growth. Towards this, the large pharma companies are getting dependant upon alliances and in-licensing to gain access to technologies and new molecular entities from the biotech players. The year 2008-09 has been a year of consolidations that is changing the face of the industry. Whether it is Ranbaxy-Sankyo deal, Pfizer’s acquisition of Wyeth, Merck’s purchase of Schering-Plough or Genentech’s deal with Roche, the strategy is all the same i.e, to build a robust business model for competing in the new global marketplace. With many blockbuster drugs going off-patent in the next few years, innovation is one area we all have been focusing on. This has resulted into partnering or acquiring newer compounds from smaller, independent, innovation-focused biotech companies. In 2008, bio-pharma companies spent more than $60 billion on R&D worldwide. Global industry performance According to Ernst & Young’s “Global Biotechnology Report 2009,” the global biotechnology industry delivered a solid financial performance in 2008 despite worldwide economic turmoil. According to the report, there are  four sweeping paradigm shifting trends that should lead to new, more sustainable ways of funding drug development: a wave of generic drugs based on today’s top blockbusters, the expansion of personalized medicine, fundamental healthcare reform in the United States, and the continued globalization of the industry. “This is not business as usual for the biotech industry,” said Glen Giovannetti, Ernst & Young’s Global Biotechnology Leader. “Unlike prior funding droughts, this crisis is systemic, deep and protracted. To thrive in this environment, firms will need to bring the creativity that has long been the industry’s hallmark in establishing more durable models for funding innovation.” New pathways to sustainability The challenge for the industry, according to Glen Giovannetti, is turning an existential threat into a Darwinian opportunity. The potential solution lies in four paradigm-shifting trends that promise to accelerate the transition to sustainable business models: Generics: Generics based on today’s top blockbusters should loosen governments’ and insurers’ budgetary constraints and mitigate pricing pressures on innovative drugs, permitting better margins. US healthcare reform: The potential shift toward universal healthcare coverage in the world’s largest drug market will likely incorporate pay-for-performance in reimbursement decisions. Incentives for true innovation should help biotechs sustain returns. Personalized medicine: Personalized medicine will increase the relative value of research and early development—biotech’s traditional strengths—giving biotechs more bargaining power and better valuations. Meanwhile, more efficient drug development will lower R&D costs, making it easier for firms to make the journey to self-sufficiency. Globalization: Growing strengths in emerging markets will facilitate creative solutions—from new “win-win” ways of allocating increasingly valuable ex-US rights to creative alliances and new sources of capital. Meanwhile, Asian business models could provide solutions for struggling Western firms. “But these trends will also bring new market pressures—from a higher bar on reimbursement to new sources of competition. “To seize the opportunities in these four drivers, companies need to be proactive,” said Giovannetti. “Firms should understand how these trends impact them, prepare for them, and where possible, help shape them.” Regional performance Although lack of capital fund in 2008-09 has been an issue, but with most of the countries today having well-developed biotechnology programs coupled with right strategy could overcome the financial crisis and went ahead registering good growth. According to E&Y, revenues of US public biotechs grew by 8.4 percent in 2008, down from 11.3 percent in 2007. The US publicly traded industry posted an aggregate net profit of $0.4 billion for the first time. Despite the crisis, venture capital raised in the US reached $4.4 billion in 2008—the second-highest total in history, behind only the record $5.5 billion raised in 2007. Europe registering a better performance, revenues of public biotechs increased 17 percent to €11.2 billion but capital raised by European biotechs fell from €5.5 billion in 2007 to less than €2 billion in 2008. Coming to Asian biotech industry performance, the Asia Pacific biotech revenues grew by 25 percent in 2008, led by strong growth in Australia. In Australia, public-equity funding fell to levels not seen since 2002. There were a handful of IPOs in Japan and China and strong private-equity funding growth in India. According to the Scientific American report released at BIO 2009, countries like Brazil, China, India, Singapore, Denmark and Israel have emerged with enormous bioscience potential. While the US retains its preeminent position in the biotechnology sector overall in terms of innovation capacity, it doesn’t top in every category. Israel leads when it come to foundations support, i.e., how much business and government expenditures are earmarked annually for biotech infrastructure development. Israel has the greatest business expenditures on R&D as a proportion of GDP than any other country. Other interesting countries include Singapore, which has the most post-secondary science graduates per capita, followed by Ireland and Australia. And in 2008, Iceland is described as having high biotech intensity, a measure of the amount of commercial biotech activity. Iceland has the greatest overall intensity, it has the most public companies per capita followed by Denmark and the most public company employees per capita followed by Ireland. Government support As investments in most aspects of biotech and biomedicine are likely to pay-off over the long haul, the governments are playing a significant role and coming up with some of the most aggressive programs to support biotech in the respective countries. Year 2008-09 has been good in terms of government support and policies. It all started with President Obama reversing restrictions that former President George W Bush imposed on federal funding for stem cells in 2001. And in a move signaling the beginning of a new age in stem cell research, the Food and Drug Administration (FDA) approved the first-ever clinical trial of stem cell therapy on human subjects. Joining the league, the Drug Controller General of India (DCGI) too gave its nod to a proposal on stem cell-based research for human clinical trials in India. Introduction of a regulatory pathway for biosimilars in the US, the Australian government approving field trials of GM Canola and the Taiwan government establishing a $1.7 billion venture capital fund with the aim of turning the island country into a biotech hub are yet other developments in this direction. Thus looking at the positive impact of the recent upsurge in M&A activity, evolved strategies paired with good government support, the future prospects of the industry can be assessed to sustain good growth.  Jahanara Parveen ]]> <![CDATA[Recession slows down industry growth in APAC]]> https://biospectrumindia.com/news/95/2197/recession-slows-down-industry-growth-in-apac.html https://biospectrumindia.com/news/95/2197/recession-slows-down-industry-growth-in-apac.html Wed, 08 Jul 2009 10:36:00 +0530 Recession slows down industry growth in APAC Life science industry in Asia Pacific has encountered its first speed breaker year in 2008 and the outlook for 2009, though positive, is not particularly optimistic. Year 2008 was a year, when one expected that the critical mass life science industry had gained in 2007 will show great results, but uncertain economic climate and the currency fluctuation took its toll. However, it is worth mentioning that the situation is not as bad as some other industries. The overall outlook is still positive. The industry, which according to BioSpectrum estimates was pegged to grow at 13 percent in 2008 has registered an overall growth of 3.5 percent clocking $107.21 billion in revenues. This figure includes total revenues from sales, licensing, and service income of the companies in the Asia Pacific region, excluding Japan. The scope of the survey is limited to core life science companies spanning the segments of pharmaceuticals, biotechnology and medical devices across Australia-New Zealand, China, India, Malaysia, Singapore, South Korea and Taiwan. General healthcare and equipment providers are excluded from this survey. The BioSpectrum research team has used its discretion to make some exceptions to these exclusions keeping in view the industry landscape in various countries. The countries where exceptions have been made include China, Taiwan and Malaysia. While the survey spanned all the publicly listed life science companies across stock exchanges in Asia the estimations on private companies was arrived at by a sample survey across countries, corroborated with market estimates from the various industry associations in respective countries. (*for the year April 2007-March 2008) The industry gets hit by slowdown, grows at 3.5%, clocks a total revenue of $107.21 billion Industry growth in 2009 is pegged in the range of 3-5% Chindia accounts for 52% of the Asia Pacific life sciences industry The revenue figures across these Asia Pacific markets were standardized to US dollars and the calendar year to arrive at the estimates and company ranking. The growth has been estimated factoring in currency fluctuation, which is a global market reality today. (BioSpectrum Asia Pacific Survey 2008 does not use constant dollar rate.) Currency fluctuation has resulted in many of the companies showing a negative growth when standardized to US dollar. The statement applies more to South Korea than any other country. The research team at BioSpectrum estimated the industry figures by extrapolating the data available from the survey of the public listed companies in the region and corroborating it with the data available from the various research reports, and country statistics released by various government agencies and industry experts. BioSpectrum estimates the growth in 2009 to be in the range of 3-5 percent. The economic climate is unlikely to show substantial change until 2010. In 2008, of the total industry revenue of $107.21 billion about 78 percent came from pharma and pharma outsourcing services. Medical technology accounted for 12 percent, followed by biotech at 10 percent. In terms of segment share, a trend that is likely to pick up in the years to come is the increasing biotech share in the overall revenue. In 2008, the biotech share in the revenue increased by 2 percent marking the beginning of the shift. China & India led the growth making up for 52 percent share of the overall revenue with China clocking $33.23 billion and India following it with $22.51 billion. This was followed by Singapore, South Korea, Australia-New Zealand, Taiwan and Malaysia in that order. Singapore has shown a remarkable increase of close to 3 percent over its share in overall revenues of 2007. This is the highest increase recorded among the countries. The island nation's biomedical infrastructure investment is beginning to record good returns from this year. In 2008 survey Australia and New Zealand have been clubbed together making up for 12 percent in the overall pie with New Zealand accounting for 1.3 percent share. The revenues of the 273 publicly listed companies account for 30.72 percent of the overall revenue of $107.21 billion. India led the region clocking $14663.37 million, making up 44.29 percent share of the publicly listed companies' revenue. China became a distant second with 18.57 percent share in close contest with Australia's 18 percent share. It was followed by South Korea, Taiwan, Malaysia & Singapore. The Top 3 companies CSL and Sigma Pharmaceuticals of Australia and Ranbaxy of India made up 36.25 percent share of Top 20 companies generating over $6 billion of revenues during the calendar year 2008. It accounted for 18.51 percent share in the overall revenue of public listed companies. In the Top 20 list the top 5 companies accounted for close to 50 percent revenues. However, in 2008 most companies registered a decline in revenue growth with only 6 of the Top 20 companies recording a positive growth. In fact, due to pricing pressures and currency fluctuations about 50 percent of the companies surveyed showed negative growth. Of this most notable was Mindray Medical of China that grew over 75 percent to improve its ranking by a great leap to 9th position from the last year's 20th position. Wockhardt of India grew over 60 percent only to retain its 8th rank in the list. China Pharma Group made it to Top 5 with a growth of 38.2 percent India's Ranbaxy Laboratories, which was acquired by Daiichi Sankyo, even though declined marginally improved its position to Rank No 4 largely helped by the slow growth of its closest competitor in India Dr Reddy's Laboratories. The Top 20 companies list was dominated by pharma and biopharma companies with the exception of China's Mindray Medical and Australia's Cochlear. In 2008, South Korea made it to the list with 4 companies-Dong-A, Yuhan Corporation, Hanmi Pharmaceutical, and Daewong Pharmaceutical. India dominated the list with 9 companies. Revenues from the companies listed on Indian stock exchanges made up 44.29 percent share of the total publicly-listed company revenues. This was followed by China and Australia with about 18.57 percent and 18 percent share respectively. South Korea made up for 15.26 percent. In 2008, four companies made it to the billion dollar club, with Top 2 CSL and Sigma from Australia having revenues in excess of $2 billion. The next two companies Ranbaxy and Cipla of India made it with a little over a billion. The year also saw 6 new entrants split between China & South Korea make it to the Top 20 list. A strong indication of the growth in these countries. From the 273 publicly-listed companies surveyed only 15 had revenues in excess of $500 million. However, the number of companies with revenues in excess of $100 million grew to 76, quite an improvement over last year's figure of 52 companies. Overall, the publicly listed companies averaged a growth of 11.64 percent. In 2008, at the regional level for publicly listed companies China became the fastest growing market showcasing a percentage change of 45.93 percent. Malaysia followed in with 32.21 percent growth and Singapore companies averaged a growth of 23.32 percent. Taiwan companies also grew over 13 percent. Australia and India did not average to a double digit growth dragging down the overall performance. Looking at the growth of revenue blocks, in South Korea companies below $10 million revenue grew at phenomenal 125.68 percent. While in Australia it was the companies in the range of $11-$50 million that showed a growth of over 40 percent. However, for companies in the range of $300-$600 million the large countries Australia, India and South Korea showed a drop while China recorded a growth of over 30 percent. Australia also averaged a decline for companies with revenues in excess of $600 million. Nandita Singh Recession slows down industry growth in APAC ]]> <![CDATA[Vaccine majors drive business]]> https://biospectrumindia.com/news/95/1923/vaccine-majors-drive-business.html https://biospectrumindia.com/news/95/1923/vaccine-majors-drive-business.html Wed, 08 Jul 2009 10:21:00 +0530 Vaccine majors drive business The biotech industry’s growth momentum slowed down in 2008-09. The overall prevailing economic conditions forced several companies to slow down their activities. The sudden change in the investment environment was also a major deterrent. However, the Indian players managed to wade through this crisis focusing on leveraging their strengths and relationships. Biopharma relying on exports The BioPharma segment consolidated the exports business. Exports accounted for over 68 percent of the total industry. And the vaccines business is the largest contributor to the BioPharma sector with 46 percent share and revenues of Rs 3,587 crore. The therapeutics business accounted for 37 percent share, recording 26 percent growth compared to the previous fiscal’s business of Rs 2484.90 crore. Statins and insulin were the major market segments in the therapeutics business. Pune-based Serum Institute of India was the top biotech and Biopharma company in India with Rs 1,114 crore in revenues in 2008-09. It is the largest vaccine manufacturer in the country. Founded in 1966, Serum Institute of India produces and supplies low-cost, life-saving vaccines for children and adults and is also the world’s largest producer of measles and diphtheria-tetanus-pertussis (DPT) vaccines. An estimated two out of every three immunized children in the world have received a vaccine manufactured by the Serum Institute. Serum is working on several interesting areas. It has entered into a unique partnership with Syracuse University, a private research institute based in New York, to make life-saving vaccines accessible to children living in some of the most impoverished areas of the world. The institute awarded $250,000 to a team of SU researchers led by Robert Doyle, assistant professor of chemistry in the College of Arts and Sciences, to develop new oral vaccines against tetanus and rotavirus, a severe form of diarrhea that affects infants and young children worldwide. It has been commissioned by WHO to develop the vaccines against the latest strain of H1N1 too. Biocon with BioPharma revenues of Rs 912.34 crore was the second largest player and is the leader in the therapeutics segment. After divesting its enzymes business a few years ago, Biocon has developed a very rich pipeline of bio generics, which includes insulins, biosimilars and monoclonal antibodies. It also received regulatory approval in India for Glargine, a very important drug for the insulin segment. Panacea is the third largest player in the BioPharma segment. The top three players collectively accounted for a third of the total BioPharma business in the country. The top 20 players in fact accounted for close to 60 percent share of the market. Biogenerics are now being seen as a major opportunity for most of the companies in India as Europe has issued guidelines for four biosimilar products including insulin. In the US, product-wise guideline has not been issued by the USFDA . The biosimilars bills have been proposed for discussions in the house and one of them calls for a five-year exclusivity and it gives opportunities of both having a biosimilar molecule as well as a switchable bio generic molecule. And several pharma companies in India are also eying this market opportunity and finalizing their plans. Bioagri records good growth The bioagri sector consolidated its domestic business and grew by 34 percent to Rs 1,494 crore. India today is a global powerhouse in cotton. This has been possible because of the introduction of Bollgard Bt cotton. India’s cotton production has increased to 29.5 million bales in 2008-09, after touching an all-time high of 31 million bales in 2007-08, and up from 16 million bales in 2001-02. In 2007-08, India also earned export revenue of US $2-3 billion from export of 10 million bales of cotton (India was a net importer in 2001). Within six years of introduction of Bollgard Bt cotton in 2002, India has become the world’s second largest producer and second largest exporter of cotton. Mahyco Monsanto Biotech (MMB), a 50:50 joint venture formed between Monsanto Holdings and Mahyco in 1998, is the key licensor of Bt cotton technologies like Bollgard (single-gene technology) and Bollgard II (double-gene technology) to Indian farmers. MMB has sub-licensed the Bollgard technology to 23 other Indian seed companies, each of who introduced the Monsanto gene into their own germplasm. Currently, sold in nine states in India, farmers have a choice of over 200 Bollgard II and Bollgard Bt hybrids, in addition to non-bt hybrids and varietal seeds. Approximately 4 million farmers cultivated Bollgard Bt cotton seeds on 76 percent of India’s total 225 lakh cotton acres in 2008, up from 72,000 acres in 2002 (Source: MMB). India is now witnessing a second wave of Bt cotton and farmers are upgrading to the superior Bollgard II technology that gives better pest protection against bollworms and spodoptera caterpillar, and higher yields. Meanwhile Bangalore-based Metahelix has also got approval for a new Bt Cotton technology. Tamil Nadu-based Rasi Seeds was the top BioAgri company with Rs 375.59 crore in revenues registering 28 percent growth compared to that in 2007-08. Hyderabad-based Nuziveedu Seeds was the second largest player with Rs 363.96 crore in revenues registering 25 percent growth, and Mahyco grew 55 percent to Rs 211.12 crore. Top three players’ combined revenues were Rs 950.67 crore and accounted for 64 percent share of the total BioAgri market. The top 10 players with Rs 1198.34 crore in revenues accounted for 80 percent share of the total BioAgri market. Ch Srinivas Rao ]]> <![CDATA[Food & Beverage Focus 2009 to discuss Biotechnology applications in the sector]]> https://biospectrumindia.com/news/95/2194/food-beverage-focus-2009-to-discuss-biotechnology-applications-in-the-sector.html https://biospectrumindia.com/news/95/2194/food-beverage-focus-2009-to-discuss-biotechnology-applications-in-the-sector.html Tue, 09 Jun 2009 17:45:00 +0530 Food & Beverage Focus 2009 to discuss Biotechnology applications in the sector The use of biotechnology (BT), which initially was employed in the traditional food processing sector in the form of home-made fermented cheese and yoghurt, is now one of the frontline technologies in food and beverage and dietary supplements sectors. Resultantly, several food and supplement segments have transformed into high value markets. Diverse technologies such as gene modification, transfer, in-vitro vegetative propagation of plants, to name a few, have been used in agriculture in order to improve crop yield and create disease resistant variants. Food & Beverage Focus 2009, to be held on July 24 at Intercontinental the Lalit in Mumbai, will he plunging into such topics surrounding the biotechnology trends, associated safety hazards and leveraging BT in the industry. The event is being organised by Frost & Sullivan and the theme would be "Biotechnology applications in F&B sector and dietary supplements sector." Biotechnology is being extended to the processed food and dietary supplements sector with the objective to improve quality, yield, and efficiency of end products. With the increase in demand for functional / value-added foods, beverages and supplements in India, BT plays an important role in accelerating the segment through invention of key functional ingredients such as enzymes,amino acids, vitamins, Omega-3, probiotics, prebiotics, etc. The idea of this summit is to bring together industry players in the food and beverage and dietary supplements industry across the entire value chain to discuss key issues and developments. This knowledge sharing platform by Frost & Sullivan will provide an opportunity to discuss current developments/trends in the food, beverage and dietary supplements sectors. The summit will provide an ideal platform for food processors to interact with key decision-makers in the value chain. The industry players could benefit by leveraging new technologies and gaining insights into the future growth and scope of biotechnical dvances. The discussion would lay special emphasis on customer requirements and anticipated product developments in the market Innovation and global trends would be another area of discussion. ]]> <![CDATA[â€œBeing competitive is very important for survivalâ€?]]> https://biospectrumindia.com/news/95/2048/being-competitive-is-very-important-for-survival.html https://biospectrumindia.com/news/95/2048/being-competitive-is-very-important-for-survival.html Tue, 09 Jun 2009 17:29:00 +0530 “Being competitive is very important for survival” —Dr Raju Barwale, managing director, Mahyco, Aurangabad Dr Raju Barwale has been in the seed business for over thirty years. He is credited for revamping the company’s management structure to get a competitive edge in the industry. In a tete-a-tete with BioSpectrum, the media-shy Dr Raju Barwale shares Mahyco’s achievements over the years, gives his perspective on the development in seed industry, government policy initiatives and the latest development in Bt brinjal. Can you elaborate on some of the major achievements of Mahyco in the past one year? Achievements of Mahyco in 2008-2009 were from the management side. An old organization like Mahyco has to face a lot of challenges and we are initiating the first phase of change to equip ourself to face the future. We looked at an organizational structure to support our plans and strategies. For that we have to find more resources because irrespective of the size of the organization, resources are always limited. Being competitive is very important for the survival and growth of the company in the future. You need to change with the times. We have considered other parameters like access to technology, the  kind of  partnerships and collaborations to go into and the kind of relationships we need to have with such collaborations; Mahyco also tries to tap the business opportunities in neighboring countries, all these in my opinion are achievements in itself. Mahyco is now changing from an owner-driven organization to a more structural and professional  managed  organization. The segregation between ownership and management is one of the major achievements of Mahyco. Another milestone for Maycho was the launch of Bollgard II technology in 2008-09 and is achieving some significant volumes. What are the  major collaborations and alliances that happened in the past one year? Biotechnology is such a field where you need to have alliances and collaborations because a company cannot  be a master of everything. We have alliances with Monsanto, Cornell university, Michigan State university and Delhi University South campus. We believe in accessing technology from all over India and also overseas; and collaboration is the way forward. I think everybody in the course of time will realize that and there is an effort from universities and institutes to collaborate and even the Government of India has taken some initiatives. Mahyco  has initiated  some projects with the government which is still  in discussion stage especially  for hybrid rice licensing How favorable have government policies  been  to the bioagri sector?  We are in a field which is a very delicate  and the industry would like to see a balanced approach of policies. Like for example, the government has encouraged research work and in turn will provide funds, so that is a positive sign of encouragement. On the other hand,  for some reason there is a bias notion among the policy makers that seed companies are making too much of money which I feel is incorrect. We are like any other industry which is to get as much as return as possible. When companies from other industries can make profit why is that a seed company cannot  make a huge profit like them? Unless and until that  change in thought process does not come in the minds of policy makers, it will be difficult for the industry. One big example is the pricing issue and it is our understanding that the pricing issue is more driven by emotions than facts. Like for instance, for the change process at  Mahyco, we  have been given an assessment that over a period of 10 years we have to invest around Rs 900 crore in R&D, people, facilities and so where will the money come from if this is the attitude. What is the secret behind Mahyco’s growth despite economic slowdown? Although there was a change in terms of demand and production, recession has not affected the agriculture sector. But, as we all know, as the market changes, industry learns to adapt to that change. By and large the perception is that  we have not been impacted.  What are the major developments in introducing Bt brinjal? Bt brinjal is at various stages of the regulatory system. We have completed all our studies, we are completing additional information collation requested by regulatory authority. Now it is difficult to say the time span for commercial release. Without the help of the government we would not have come so far. There has not been a single instance where the government has refused permission for trial research  and of course as far as  the anti-GM lobby is concerned it is but natural for the opposition. Whenever something is introduced in the country, there will be opposition and conflict. The regulatory authority is also learning in the process.  Nayantara Som ]]> <![CDATA[Pharmaceutical Outsourcing Congress India 2009]]> https://biospectrumindia.com/news/95/7834/pharmaceutical-outsourcing-congress-india-2009.html https://biospectrumindia.com/news/95/7834/pharmaceutical-outsourcing-congress-india-2009.html Tue, 09 Jun 2009 17:27:00 +0530 Pharmaceutical Outsourcing Congress India 2009 Your route to successfully conducting research and clinical trials in India July 28th – 30th, JW Marriott Hotel, Mumbai, India Calling all senior pharma and biotech executives – your exclusive invitation to the biggest blockbuster event of the year. Happening this July in Mumbai and hosted by The Ideas Exchange, the VIP list of speakers discussing the key issues surrounding Indian outsourcing include: The Hon’ble Mr Ashok Kumar; Secretary, Department of Pharmaceuticals; Venkat Jasti of Suven; Dr Somesh Sharma of Piramal’s; Nimish Vachharajani of Advinus; Mr Daara Patel, Secretary General, IDMA; Dr S P Vasireddi of Vimta Labs and over 30 other industry leading speakers. If you’re interested in big business then you have to be interested in the Outsourcing Congress. This is your key to ensuring your revenues and profits remain In-house and don’t get outsourced to your competitors. For more details please visit www.pharmaoutsourcingindia.in or contact Vikas Vij on tel: 0091 98 2047 1059 or email: vikas.vij@ideas-exchange.in. ]]> <![CDATA[US-India partnerships grow even during the global economic slowdown]]> https://biospectrumindia.com/news/95/2679/us-india-partnerships-grow-even-during-the-global-economic-slowdown.html https://biospectrumindia.com/news/95/2679/us-india-partnerships-grow-even-during-the-global-economic-slowdown.html Tue, 09 Jun 2009 17:09:00 +0530 US-India partnerships grow even during the global economic slowdown US-India BioPharma and Healthcare Summit, an annual summit organized by the USA-India Chamber of Commerce which brings together all stakeholders of the sector to facilitate trade and investments in US-India corridor, had attracted over 300 senior biotech, pharmaceuticals, medical devices and academic leaders this year. Over 75 percent of discovery heads who participated in the annual Biopharma and Healthcare Summit felt the environment for drug discovery research collaboration between US and India has increased in the last 12 months.  In his opening remarks, Karun Rishi, president of the USA-India Chamber of Commerce applauded the efforts of the Government of India to make the country an innovation hub by 2020 and termed it as a bold initiative. Rishi also added that it will be feasible and realistic only when all the stakeholders are engaged and work together to fulfill this goal. Decision making and the implementation process have to be at a faster pace. He also stressed the need for greater industry-academic partnerships to foster innovation. There is an urgent need for partnerships between the US biopharma industry and Indian academia and between Indian industry and US academic institutions. “We have created an ecosystem to bring together all stakeholders: industry, investors, academia and policy makers. This has become the only biopharma and healthcare summit in the world that attracts the largest number of senior stake holders from the US and India at one location every year. Participants’ mood was very upbeat,” observed Rishi. Panel discussions conducted at the summit covered areas like drug discovery, clinical research, funding innovation, merger and acquisition trends, and industry-academic partnerships. Discovery and clinical research heads of major biopharma companies participated in the summit. The summit saw representation from  major companies like Amgen, Bristol Myers & Squibb, Elli Lilly & Company, Pfizer, Merck & Co, Biogen Idec, Genzyme, Johnson & Johnson, AstraZeneca, Schering Plough, Novartis, Reliance Life Sciences, Jubilant, Aurigene, Orchid, Suven, GVK, Sanofi Avantis. Other participants include academic leaders from 20 medical and public health schools and over 30 life sciences focused venture capitalists and private equity firms. Dr Martin Mackay, president, global R&D, Pfizer, in his Keynote address observed: There is a great willingness to collaborate in India. Indian companies have great ability to adapt to western needs. There is a huge medical need in India, especially for infectious diseases. Dr Mackay noted, “This is the golden age for drug discovery. The availability of tools, technologies, manpower and global access to develop products that are needed to treat health not just in the US but on a global scale are enhancing drug discovery.” Many biopharma companies spend their R&D investment in brick and mortar. Partnership model helps in avoiding duplicating this expense and helps to focus investment on pure R&D. Pfizer is working with partners in Asia on specific programs specific to Asia and world.” According to Dr Mackay, “The key challenge in drug discovery is to make medicines available globally and at affordable prices. The task for the R&D head is develop medicines that the patients can use. So the model has to change.” Dr William Chin, vice president, discovery research and clinical investigation, Eli Lilly, felt the pharma industry is under siege with flood of patent expiries, higher safety hurdles and pricing pressure. According to Dr Chin, there is too much clinical data available in the world, but the challenge lies in converting that data into knowledge for drug discovery. India with its IT strengths can play a vital role. Dr John Thompson of Vertex Pharmaceuticals felt the need for open source-based research. Dr Thompson urged for balance between opportunity and purpose for neglected diseases like tuberculosis where one-third of the world is infected with it. Purpose from Indian point is important and the purpose-driven research leads to opportunity. Government support is needed for tackling neglected diseases in India. Dr Joe Smith, vice president at Johnson & Johnson said, “India can be a major center for innovation globally. Johnson & Johnson doesn’t view India as an emerging market. Dr Smith felt the infectious innovation can come from India. J&J is looking at ways to engage India. The company has spent $8 billion on R&D globally and is working at creating academic partnerships in India.” Investors who participated at the summit observed that pharma has been the biggest creator of wealth whereas biotechnology has been a biggest looser for investors. There is an opportunity to tap the corporate venture funds of large pharma companies. KV Subramaniam, CEO of Reliance Life Sciences felt that corporate funding will be available along with other capital sources but corporate investor will be more prudent in investing their funds. “Investments in innovative Indian companies are considered risky. To spur investments in emerging companies, there is a need for local venture capital firms syndicating their investments. There is an opportunity for private equity and VC investors to partner with the government to invest in healthcare infrastructure and innovation, especially in the current resource constrained global economy,” said Subramaniam. Nobel Laureate Prof. Sidney Altman, Dr Barry Bloom of Harvard School of Public Health and Dr Michael Rosenblatt, dean, Tufts Medical School, stressed on the need for greater investments in education and public health in India. About 80 percent of ideas used in biotech and physical sciences came from academia and were later picked up by the industry. To support the industry, India has to increase the quantity and quality of human resources. Challenges are enormous but India has the capability and potential to deliver. Representing Department of Pharmaceuticals, Paresh Johri, Deputy Secretary reiterated Government of India’s plan to promote innovation and R&D in pharmaceuticals. Making India a pharma innovation hub by 2020 can create five lakh additional jobs. Department of Pharmaceuticals has submitted a proposal to the PMO to create a fund to invest $1-$2 billionevery year till 2020 to fund pharma innovation.  ]]> <![CDATA[Biotech speed breakers]]> https://biospectrumindia.com/news/95/7297/biotech-speed-breakers.html https://biospectrumindia.com/news/95/7297/biotech-speed-breakers.html Tue, 09 Jun 2009 17:00:00 +0530 Biotech speed breakers It is time for the reality check for India’s biotech industry. After five years of heady growth, the relatively small biotechnology industry (compared to pharma and health care) seems to have hit the speed breakers. The years of 30 percent or more growth came down to 21 percent in 2007-08. The trend continued in 2008-09 with the growth in rupee terms registering a modest 18 percent growth to reach Rs 12,137 crore, according to the 7th BioSpectrum-ABLE Biotech Industry Survey. The data put together by the BioSpectrum team in the last month indicates some interesting happenings. The industry continues to depend on exports of products and services for growth. And so the foreign exchange rates are critical to the overall numbers. The year 2008-09 recorded an average 17 percent depreciation against the US dollar and this has straightaway boosted the topline of the Top 5 pharma companies who are dependent on exports of vaccines and therapeutic products. This is corroborated by the 18 percent increase in rupee terms. However, in dollar terms, the growth has remained flat at the previous year’s $2.5 billion. The surge in dollar numbers in 2007-08 has more or less been nullified by the depreciation in rupee. India’s domestic market growth was just about 9 percent, indicating limited demand for products and services. In fact, the biotech industry’s growth has mainly come from the popularity of Bt cotton seeds, sold by two dozen seed companies. Despite government mandated reduction in Bt cotton seed prices, collectively BioAgri companies grew by 24 percent touched nearly Rs 1,500 crore in sales. The increasing profile of transgenic seeds companies is reflected in the No.4 and No.5 positions occupied by Rasi Seeds and Nuziveedu Seeds in the BioSpectrum-ABLE Top 20 company rankings. There are  few other interesting trends visible in the performance of the biotech industry in 2008-09. The BioSpectrum-ABLE Top 20 list is now dominated by home-grown companies, with the exception of a few consistent MNC performers like Novo Nordisk, Novozymes, GSK and EliLilly. This was not the case in the first five years of the survey which started in 2003. Pune-based Serum Institute continues to maintain its grip on the No.1 slot for the fifth year in running and has achieved a milestone of crossing the Rs 1,000 crore mark for the first time. Biocon too would have been very close to the top slot but for its significant mark-to-market losses. The Top 2 are however ready with some interesting initiatives for the next few years. Serum Institute is poised to become a global supplier of the swine flu vaccine and increase the industry profile. Biocon’s strong product portfolio has started to make an impact in the domestic and global markets. Two other bellwethers, Shantha Biotech and Bharat Biotech too have had a good growth year, both crossing the Rs 200-crore mark for the first time. The bioservices market registered over 30 percent growth and continued to be the fastest growing sector. Indian companies like Mumbai-based Siro Clinpharm, Jubilant, and Biocon subsidiary Syngene International today have expanded the bioservices market significantly. Each of them today has revenues of about $40 million and are inking pacts with several global players and consolidating their service offerings across the value chain of discovery and development and their global positions. The industry is optimistic that it is on the path to recovery as several things that were concerning the industry like funding, regulatory issues, government support, industry-academia collaborations, and public-private-partnerships are falling in place. The vaccines industry is now buoyant, the pharma sector is gearing to enter the biosimilars space, and the agri sector is looking at responsibly introducing transgenic technologies. The industry is innovating and preparing for the next level of growth. <sureshn@cybermedia.co.in> ]]> <![CDATA[Rank 21-50 Companies]]> https://biospectrumindia.com/news/95/5921/rank-21-50-companies.html https://biospectrumindia.com/news/95/5921/rank-21-50-companies.html Tue, 09 Jun 2009 15:14:00 +0530 Advanced Enzyme Technologies Limited is an industrial enzyme manufacturer and caters to a worldwide market like Europe, America, China and India. The company specializes in providing customized, eco-safe solutions across various industries. The key areas that Advanced Enzymes focus on are human healthcare, animal healthcare, textiles, leather and grain processing. Being an R&D focused company; Advanced Enzyme Technologies has several patents and novel applications to its credit. AETL clocked biotech revenue of Rs 88.60 crore for fiscal 2008-09 as against Rs 69.30 crore in 2007-08, registering 42 percent growth. About 50-60 percent of the company's export caters the needs of the US market. The company also spends around 10-12 percent of their total turnover on R&D. Advanced Enzyme Technologies is expecting a stable growth in the current fiscal with exports growing, especially in the area of bulk enzymes. GlaxoSmithKline Pharmaceuticals (GSK) recorded total biotech sales of Rs 83.48 crore in 2008-09 as against Rs 80.40 crore in 2007-08. Vaccine has been a key growth area for GSK in the Indian market. GlaxoSmithKline in India is an affiliate of GlaxoSmithKline Biologicals, headquartered in Rixensart, Belgium. Belgium is the center of all GlaxoSmithKline's activities in the field of vaccine research, development and production. GSK's India product portfolio includes prescription medicines and vaccines. GSK also offers a range of vaccines against hepatitis A, hepatitis B, invasive disease caused by H, influenzae, chickenpox, diphtheria, pertussis, tetanus etc. As of now, GSK markets 12 types of vaccines in the Indian market. GSK has two manufacturing units in India, located at Nashik and Thane as well as a clinical development center in Bangalore. Vimta Labs is a contract research and testing organization that has a track record of serving several market leaders across the globe. Vimta has a team of 621 professionals comprising 466 scientists in various disciplines such as chemistry, pharma, medicine, microbiology, molecular biology and informatics. The team is slated to double in next three years. Vimta is a multi-site organization with more than 300,000 sq.ft. world class laboratory facilities. The company recorded a total business revenue of Rs 81.60 crore posting 6 percent growth over that in 2007-08. Ankur seeds clocked revenue of Rs 80.35 crore in Bt cotton seed sales for fiscal year of 2008-09 as against Rs 75 crore in 2007-08. The company has released new cotton hybrids like Bollgard II during the fiscal year of 2008-09, other hybrids like Ankur Jai BG II and Ankur 3028 BG II were released for northern, central and southern India. Ankur Seeds got permission from the regulators to import the transgenic cotton seed material containing drought tolerance genes. The company had funded an American University for developing these transgenic lines. Ankur Seeds has successfully developed cytoplasmic genetic male sterility that will have long term benefits in brinjal hybrid seed production technology. The company is planning to enter the regulatory trials of Bt brinjal that were developed at its facilities using proprietary gene construct. For the past four decades, Wockhardt's forte has been its pharmaceutical and biotechnology business which is backed by research-oriented technology. Wockhardt's pioneering efforts in biotechnology led to the launch of three successful products in the Indian market: Biovac-B (hepatitis B vaccine), Wepox (erythropoietin), and Wosulin (recombinant insulin). The company has also made a breakthrough by launching a novel long-acting insulin, Glargine. Wockhardt is prepared to tap biogenerics opportunity, which is powered by its vision to introduce one biopharmaceutical product every year. Wockhardt is a listed entity altogether with its R&D locations in Wockhardt, Aurangabad and Mumbai; Negma Laboratories, France; Morton Grove Pharmaceuticals, Illinois, USA; Wockhardt, UK and Pinewood, Ireland. Krishidhan Seeds Limited clocked a total turnover of Rs 63.25 crore in FY 2008-09 as compared to Rs 40 crore in 2007-08 from Bt cotton. Krishidhan's R&D spend is about six percent of its total sales covering both the basic and applied research in agribiotechnology. Although the company decided to enter into GM crops in 2001, it was able to launch its products in 2006 due to delay in regulatory approvals and procedures. Krishidhan Seeds is using the Monsanto technology and was one of the three companies to launch Bollgard II, which was more effective than Bollgard I, in 2006-07. Krishidhan is also in the process of looking at other technologies that would control bollworm complex and other pests. At present it is mainly focusing on promoting Bollgard II technology with desired tolerance to sucking pest complex in its elite hybrid. Genesis of the company goes back to the time when Dr Pradip K Desai present chairman conceived the idea of a a start-up company in 1972, as the Desai Laboratories. The main goal of Span Diagnostics was to indigenously develop and manufacture a comprehensive range of ready-made diagnostic reagents needed by clinical pathology laboratories. Span Diagnostics is giving emphasis to in-house R&D to develop more and more products, keeping the customer needs in mind and quality under constant vigil. The initial efforts yielded success and Span became a private limited company in 1981.The company then went public in 1994, to bring in more resources and expand further. Today, Span has a wide range of quality products and dedicated services and the products are manufactured at its state-of-the-art plants in India and France, strictly following WHO-cGMP norms. Nath Biogene offers scores of new crop varieties, hybrid seeds, growth supplements and related services to farmers from all over the country. Nath Biogene's products and services have changed the demand dynamics in the country. The company made substantial investments to upgrade R&D activities to international standards. Reaching the Indian farmers with rigorously tested seed-embedded technologies for genetic enhancement is the prime goal of Nath Biogene. The company forges linkages with some of the best-known institutions within the country and abroad to enhance the research activities. Collaboration with the prestigious Biotechnology Research Institute of Chinese of Academy of Agricultural Sciences is one among them. Serum International, a subsidiary of the Serum Group, has clocked revenue of Rs 46 crore for fiscal year 2008-09. Serum Institute of India sets up Serum International Ltd to market research-based products from Serono, world leaders in fertility products. The Pune-based subsidiary of India's largest manufacturer of vaccines has many acheivements to its credit. Serum International's most talked about milestone was the launch of Pygeum Africanum soft gelatin capsule, Pyginal, for benign prostate hypertrophy (BPH). BPH is an age-related prostate gland problem occurring in males after the age of 40. BPH occurs because of enlargement of the prostate gland which is an important organ of the male reproductive system. Dr Reddy's Laboratories has clocked revenues of Rs 40 crore for the fiscal year 2008-09 as against Rs 34 crore in 2007-08. The company hopes that its key brand Reditux will be the first in a series of biosimilar products that will revolutionize the affordability of these products for patients in India. Dr Reddy's has shifted its focus to the development of biosimilars, while its long term vision is to develop new biological entities (NBEs) in niche therapeutic areas. In biologics, Dr Reddy's offers two products, Reditux and Grafeel. Otherwise, in total the company is offering 14 anti-cancer drugs, which are not biotech products. Dr Reddy's is the second largest player in oncology in India after Roche. The biotech products of Dr Reddy's are not only focused on oncology and monoclonal antibodies but also in nephrology and autoimmune diseases. Indovax is engaged in the production of quality poultry biologicals since 1991. The company's research is focused on product development for Indian (tropical) conditions. The company manufactures viral vaccines, inactivated vaccines and bacterins by using SPF eggs and the best quality raw material, sourced from renowned international suppliers. The company enjoys over 40 percent market share in Gumboro vaccine segment that was launched in the 1990s. Indovax's Hydropericardium syndrome vaccine and Fowl cholera vaccine have a similar success story. Last year, Indovax entered into a joint venture with a large European company to produce products critical to a number of biomedical and veterinary procedures, including production of diagnostic kits, reagents, disease diagnosis, biomedical research, and the production of some mammalian, human and avian vaccines. Wyeth Limited is a subsidiary of the US-based pharmaceutical company, Wyeth. The company clocked estimated revenues of Rs 35 crore (purely from its vaccine business) with its blockbuster vaccine, Prevnar (launched in 2006 in India) having a good amount of the share. Wyeth Limited has a strong presence in oral contraceptives, folic acid and depilatory cream also. It was the first company to launch hormone therapy. In the field of vaccines, Wyeth introduced vaccines against HIB and invasive pneumococcal disease in the country. Enbrel, a breakthrough treatment for rheumatoid arthritis and Rapamune, an immunosuppressant for prevention of rejection after renal transplant, Prevenar, a pneumococcal conjugate vaccine and Tygacil, the world's first glycilcycline antibiotic, are among internationally known products launched by Wyeth Limited in India. The company has a state-of-the-art manufacturing facility in Verna, Goa. Despite the economic slowdown hitting the country, Aventis Pharma's exports saw a double digit growth and showed a growth performance of 23 percent. The company's expenditure on R&D grows up to 0.51 percent and it employs 2,070 people. The company launched a new prefilled disposable insulin pen, SoloSTAR for use with the 24-hour insulin Lantus. Lantus had shown a growth rate of 30 percent and was also won the prestigious OPPI Marketing Excellence Award. This disposable insulin pen is to be used for the treatment of hyperglycemia in people with type 1 or type 2 diabetes. Aventis has state-of-the-art manufacturing facilities at Goa and Ankleshwar, where a number of pharmaceutical ingredients and formulations are produced. Both the sites comply with prevailing Good Manufacturing Practice (GMP) and Health, Safety and Environment (HSE) standards and score highly in terms of performance. Strand Life Sciences is a premier life science informatics innovation company founded by Dr Vijay Chandru, an academician turned entrepreneur. Strand leverages its core strengths and intellectual property in data mining, predictive modeling, bioinformatics, and computational chemistry to develop products and solutions for drug discovery. Strand Life Sciences is developing a new software solution for the analysis of data from Next-Generation Sequencing (NGS) experiments. This new solution incorporates algorithms optimized to process NGS data while focusing on integration with downstream biological analysis. The solution will support most of the applications being performed on NGS platforms. Strand is a member of the bioinformatics software partnership program established by Illumina Inc. to promote data integration and advanced analysis of data from various Illumina products including NGS data. Lambda Therapeutics works on all aspects of clinical drug development including clinical trials, clinical laboratory, data management, and bioavailability studies. with its head office in Ahmedabad and branches at Mumbai and Chennai; Warsaw, Poland and USA. It has an employee strength of more than 500 members. Past records of the company include having 1,000 BA/BE studies, 20 phase-I studies and 35 phase-II and phase-III clinical trials. In 2008, Lambda Bioanalytical Facility got a GLP certification from Thailand FDA. Lambda has acquired a pharmacovigilance CRO in the UK and a Polish CRO firm, CBK-MPR Pharma. The clinical lab of Lambda also received a CAP accreditation and was accredited by the most prestigious body College of American Pathologists on May 4, 2005. Lambda is one of the five clinical labs in India and the first one in Gujarat to have CAP accreditation. Rank 21-50 Companies Hester Biosciences Limited is a veterinary vaccines manufacturing company, which has ISO 9001-2000 and GMP certifications. The product range includes 11 types of live and 28 types of inactivated poultry vaccines. Propagation of micro-organisms for manufacturing of the vaccines is done through tissue culture, through specific pathogen free embryos and through fermentation processes. Having achieved a turnover of Rs 32.60 crore in 2007-08, Hester claims to have the second largest market share for poultry vaccines in India.  Hester  imports one vaccine from the US.  It also exports some of its vaccines to three countries and registration are pending in over 10 countries. Besides marketing its own vaccines, Hester represents other companies like Merial USA for poultry vaccines; Biopharm, Czech Republic, for poultry vaccines; Synbiotics, USA, for animal diagnostic kits  for the Indian market. Cadila Pharmaceuticals (CPL) is a key research-based, tech-savvy pharmaceutical company focusing on areas like formulations, new drug discovery, active pharmaceutical ingredients, analytical research, phytochemistry, biotechnology, plant tissue culture, biosynthesis, genetic engineering, vaccines and immunoglobulins. Over the last few years, CPL has established a strong R&D base in biotechnology and developed working relations with key R&D institutes in the country. CPL has its own research facility at Indian Institute of Science (IISc) Bangalore.  About 20 products including conventional and recombinant vaccines, anti-cancer biotherapeutics, diagnostics using recombinant antigens and natural thrombolites with high market potential are in its biotechnology basket. Cadila has developed Immuvac, a potent immunomodulator for the first time in the world. Sodium Hyaluronate, is another biotech product developed on the basis of technology obtained from Center for Biochemical Technology, Delhi. JK Agri Genetics Ltd (JKAL) was established in 1989 with its headquarters at Hyderabad. The biotechnology division of the company is engaged in R&D, production, processing and marketing of hybrid seeds of sorghum, pearl millet, maize, cotton, rice, sunflower, tomato, okra and hot pepper. JKAL has invested extensively in biotechnology programs and has collaborations with several national and international research institutions and agricultural universities to harness biotechnology for crop improvement. The company has developed a range of superior hybrids with Bt gene and other novel genes that fulfills farmers’ aspirations. A team of 15 scientists are currently working on the application of DNA markers such as RFLP, AFLP, SSR and ISSR, agrobacterium and biolistic mediated transformation technology in various crops using novel genes and application of in-vitro culture. Maps India is a producer and exporter of industrial enzymes. With over 150 employees, sophisticated production plant and a dedicated R&D center, Maps India has become a key player in enzymes and microorganisms. A team of 30 scientists is involved in R&D activities at Maps India. Maps produces a broad range of enzymes and microorganisms that include amylases, proteases, cellulases, xylanase, glucoamylase, pectinase, catalase and phytase, which are used for industrial purposes. With a complex product portfolio of over 60 products, a sales network that covers 20 countries and products for more than 10 different industries, Maps provides biotech solutions to improve industrial performance and quality. Maps is investing Rs 10 crore in Gujarat to expand its expansion. Suven Life Sciences is a collaborative research partner (CRP) in drug discovery for global pharma companies since 2006. The company is also focusing on contract research and manufacturing services (CRAMS) since 1995 and drug discovery and development support services (DDDSS) since 2005. Suven is engaged in discovering new chemical entities in central nervous system (CNS) therapeutic areas including Alzheimer’s, cognitive impairment, dementia, depression, Parkinson’s disease and obesity which are at various phases of preclinical and clinical development. The company has recently undergone US FDA inspection at their intermediate/active pharmaceutical ingredient (API) facility in Suryapet, Andhra Pradesh. The company’s revenues from DDDSS stood at Rs 21.03 crore. Varda Biotech is a technology and knowledge-based enterprise, offering integrated services to biotechnology and pharmaceutical companies. It engages in high-end collaboration for the products and services that enhance the capability and productivity performances of its customers and business associates. Varda offers an ultra pure and highly thermostable recombinant Taq DNA Polymerase that has been isolated from recombinant E.coli. Varda provides custom service for clients requiring custom made peptides for research use, which are of either linear sequence or modified ones. Varda has received the ISO 9001:2000 certificate. It has the technical expertise to produce and deliver quality antibodies for life science research community. The company has launched educational biotechnology kits under the brand name Bio-Knowledge Kit and has alliance with global players for product association and representation in India too. Celestial Labs has been supporting pharma, bio-pharma and biotech manufacturing with customized IT solutions and contract research. The company is also involved in R&D, commercial production and marketing of enzymes and nutraceuticals. Celestial Labs is setting up a biotechnology facility at Genome Valley in Hyderabad to manufacture its own drug molecules, industrial enzymes and contract research activities. The business plan of Celestial Labs is essentially based on the production and supply of the biotechnological products which have very significant industrial implications, especially in both pharma and biopharmaceutical sectors. Celestial Labs has been engaged in production of custom peptides for last five years. The acquisition of Bioconcept, an advanced facility for automated equipment, has establishing itself as a reliable source of contract research services on custom peptide synthesis. Shreya Group started its operation in Moscow, Russia, where Shreya Corporation, the parent company, was established in 1995. Once a one-man trading company, Shreya is a marketing and distribution company in Russia. Shreya Group has interests in both pharmaceutical and biopharmaceutical products in key therapeutic segments. Shreya Life Sciences, the Indian arm of Shreya Group, started its operations in India in 2001 by acquiring Rallis India Ltd, a TATA Group company. In 2003, Shreya acquired the domestic pharma business of Plethico Pharmaceuticals Ltd, with a view to achieve a full-fledged national presence. Some of  the products in human insulin introduced by Shreya  in India include, Recosulin-M30 40 I.U, Recosulin-M30 100 I.U, Recosulin-M50 100 I.U,Recosulin-M50 40 I.U, Recosulin-N 100 I.U, Recosulin-N 40 I.U, Recosulin-R 100 I.U and  Recosulin-R 40 I.U. Zytex (India) Pvt Ltd is engaged in marketing of a broad range of biotechnological products. Zytex believes that the product research should be backed by application development. Hence it set up an application lab in 1997 to support the customers and also to develop products from the bench scale to the customer rapidly. Based on research conducted at its center, Zytex is now in the process of setting up a new production facility for a range of therapeutic enzymes and proteins. Its research laboratory is well equipped and manned with qualified professionals. Zytex has also set up an ISO 9001:2000 certified manufacturing unit. Zytex markets a broad range of biotechnological products that are unique and are specifically demanded by customers. Zytex has strong distribution network in India and also in Asia/South East Asia. Bhat Bio-tech India specializes in the design development, manufacture and marketing of diagnostic devices for tests like pregnancy, HIV, hepatitis, malaria, dengue, chikungunya, syphlis, TB, cardiac markers, dry chemistry, biochemistry, hematology, immunology and ELISA test used in the analysis of body fluids in human. The company has registered revenue of Rs 12.10  crore in FY09. Bhat Bio-tech has recently got the technology transfer from Defence Research & Development Establishment (DRDE) for manufacturing rapid test for toxin (ricin). This is an immunochromatography-based test which will detect the ricin as low as 50ng/ml in the sample. The company has launched the rapid test for the detection of IgM antibodies for chikungunya virus in human serum or plasma and also launched the AIDSCAN HIV-1/2 Trispot Test  based on immunoconcentration principle and uses human serum or plasma and identifies HIV-1 and HIV-2 separately. Multiplex Biotech has clocked revenues of Rs 12 crore in fiscal year 2008-09 as against Rs 15 crore in 2007-08. The increased revenue in 2007-08 was a result of a bulk order placement from Andaman and Nicobar which contributed about Rs 5 crore in the last fiscal. Multiplex is promoted by Dr GP Shetty, an entrepreneur having vast experience in the field of manufacturing and marketing of agricultural products such as multimicronutrient fertilizers, pesticides, seeds, insecticides etc. The company has an unit at Nelamangala which is manufacturing wide range of agro-based biotech products which are used for the growth, development and to get more yields in field crops, fruit crops, plantation crops, horticultural crops etc. ABL Biotechnologies Limited (ABL), based in Chennai, is a pioneer in harnessing the biodiversity of the Indian marine environment. ABL has been working on identification and commercial extraction of bio-chemicals, predominantly from microbes, that have far reaching applications as nutritional, cosmetic, pharmaceutical and industrial intermediates. The microbial metabolites Laboratory at Chennai works on evaluating new sources of biochemicals from marine organisms. ABL has been conducting research on polysaccharides, essential fatty acids, natural pigments, tracers and tags with considerable success. Present focus includes work on pharmaceuticals like anti-bacterials and anti-virals, enzymes, bio-molecular materials, bio-monitors and diagnostics, bio-pesticides, bioremediation and aquaculture. ABL’s efforts are focused on the enormous potential of Indian biodiversity for the production of new tools to both fight as well as prevent disease. Metahelix Life Sciences is an agricultural biotechnology company focused on developing traits and technologies for crop protection and improved productivity. Metahelix markets hybrid seeds by its wholly-owned subsidiary seeds business, Dhaanya Seeds. Metahelix has developed two versions of Bt cotton and a Bt rice hybrid that controls rice yellow stem borer (YSB) using the Bt based Cry1Ac gene. The company’s biotechnology capability includes all the aspects of gene mining, development, molecular biology, crop transformation, phenotyping, assaying and trait development. The company’s research initiatives include developing hybrid seeds of rice, maize, cotton (Bt), millet, sunflower, sorghum, tomato, okra, hot pepper, melons. and research and development of biotech traits like insect protection, virus protection and fungal disease protection. The company currently employs 230 people and plans to hire another 40 by next year. Zenotech Laboratories is a Hyderabad-based biopharmaceutical company which develops new biological entities in the areas of cancer and neurology. The company has initiated target identification and validation programs using gene and protein based technologies. This brings together proprietary technologies in the identification of cell surface proteins and receptors as candidate drug targets. Zenotech also develops and manufactures generic biopharmaceuticals and also offers comprehensive services for generating and characterizing recombinant proteins. The company provides a full range of services from cloning a gene, expression in microbial or mammalian systems, process development and generation of milligram to gram quantities of pure recombinant proteins. The company also offers functional, validated assays in both cell-based and cell-free formats for use in drug discovery. Excel Industries Ltd primarily manufactures chemicals for industrial and agricultural needs. The business divisions of Excel include agri, chemical, and environment and biotech. The environment and biotech division has developed biodynamic products and processes for tackling environment and biotech problems. Excel’s activities include sanitization, bioconversion, bioremediation and bioaugmentation. The environment and biotech division has two product categories namely agricultural biotech products and environment biotech products. The agricultural biotech products make extensive use of naturally occurring microbes such as bacteria and fungi. The products are broadly classified under the categories of soil enrichers and biopesticides, and the division makes extensive use of naturally occurring microbes that helps in the aerobic decomposition of organic matter in its various forms such as agricultural and food waste, animal waste that includes fats and proteins. ]]> <![CDATA[Intas looks beyond biogenerics]]> https://biospectrumindia.com/news/95/1444/intas-looks-beyond-biogenerics.html https://biospectrumindia.com/news/95/1444/intas-looks-beyond-biogenerics.html Tue, 09 Jun 2009 15:13:00 +0530 Intas looks beyond biogenerics   Starting with biogenerics, Intas Biopharmaceuticals Limited is now heading for the development of proprietary and innovative recombinant biopharmaceuticals. Intas Biopharmaceuticals Limited (IBPL) clocked annual revenue of Rs 89.27 crore for 2008-2009 as against Rs 50 crore in 2007-2008.  The various business activities that IBPL is  involved in are manufacturing and marketing of biogenerics like GCSF, Peg–GCSF, IFN–β and EPO in Indian market, selling of oncology molecules in the Indian market, exporting biotech products to the semi-regulated markets, licensing out marketing rights for products per territory, contract research and contract manufacturing. When IBPL was formed as a division of Intas Pharmaceuticals, it started with a portfolio of oncology molecules. Most of the biotech molecules targeted by IBPL are in the oncology segment, which is the fastest growing therapeutic segment for biotech drugs. The oncology products of IBPL include Bonimet, Borviz, Lenome, Pemmet, Voritrop, Zolotem, Zolasta, Arsenox, Redimide, Dabaz, Merex, Arasid, Aspanese, Carbopa and Zodox, while its other biotech products include Neukine, Intalfa, Erykine and  Neupeg. IBPL has technical collaborations with LPT Germany, NewLAB, Euro Sequence, Eugenex, Cellonic, Cytolab, Biocam, Ludgers and University of Montreal while some of its marketing alliances include Panacea Biotech, Intas Pharma, Natco Pharma, Fresenius Kabi, Biogenerics Australia, Apotex Inc., Hikma Biotech, Sanbe, ACL Biopharm, Cirin Pharmaceuticals, Novex Pharmaceuticals, Al-Gharash Pharmaceuticals and Adwia Pharmaceuticals. IBPL has also developed the biogeneric molecules business for Indian and international markets. IBPL has successfully executed a product development contract with a European company. The company provides full product development services that are from process development, analytical services, and formulation development to cGMP manufacturing. IBPL has also leveraged the regulatory and manufacturing expertise that it has gained through a technology sale (manufacturing technology) for one of its products. All this has been possible due to the skilled work force which IBPL has employed over the years. The company’s average age profile is less than 30 and includes technical people with international experience. The company is primarily focusing on developing biosimilars and second-generation products (superior generics). IBPL has received the European Union–Good Manufacturing Practice (EU-GMP) certification for its manufacturing facility. Recently, the company has received quality certification from Medicines Control Council (MCC) – South Africa and Gulf Cooperation Council (GCC). During the fiscal, IBPL also launched Bortezomib injection, under the brand name Borviz, in the Indian market. Bortezomib offers effective treatment for multiple myeloma. IBPL signed an MoU with Government of Gujarat for setting up a separate manufacturing facility for monoclonal antibodies (MAbs), a recombinant mammalian platform product. The company will invest Rs 160 crore towards setting up a manufacturing facility at Sanand near Ahmedabad.   ]]> <![CDATA[Concord thrives on fermentation services]]> https://biospectrumindia.com/news/95/4782/concord-thrives-on-fermentation-services.html https://biospectrumindia.com/news/95/4782/concord-thrives-on-fermentation-services.html Tue, 09 Jun 2009 14:52:00 +0530 Concord thrives on fermentation services Using its expertise in the field of biotechnology and chemistry, Concord is concentrating on the fermentation-based products. Gujarat-based Concord Biotech Limited (CBL) clocked annual revenue of Rs 97.10 crore for 2008-09 as against Rs 60 crore in fiscal 2007-08. It is an R&D-based biotechnology company having a state-of-the-art fermentation facility. It was acquired from DSM, a Dutch MNC, and commenced operations from 2000 with the manufacturing of Penicillin-G Amidase immobilized enzyme using its polymer matrix. In 2005, Matrix Laboratories Limited announced its decision to acquire controlling stake in Concord Biotech. As per the term sheet executed, Matrix would acquire 55 percent stake in Concord Biotech. Concord Biotech has a US FDA approved biotechnology facility with a  client base that spreads across the globe including EU,US, Latin America, Korea, China, Middle East and many other parts of the world. Concord Biotech has a dedicated biotech and chemical synthesis R&D for development of biotechnology and down stream processing. Concord has built up eight dedicated biotech blocks for manufacturing statins, immunosuppressants, antibiotics and enzymes. Acquired by  Sudhir Vaid, a biotechnologist with 29 years experience, from DSM. Concord has diversified in the field of active pharmaceutical ingredients namely Lovastatin, Pravastatin, Simvastatin and Tacrolimus and has provided number of technologies on biotech products to many companies in Europe and India. Concord has received US FDA approval for its Lovastafin facilities and is striving to go for European Drug Master Files (EDMF). Concord Biotech offers fermentation services that rely on more than 30 years of experienced staff. The company has the capacity and flexibility to ferment and develop processes for a variety of microbial organisms. Concord is the largest producer of Penicillin-G Amidase enzyme and is exporting this enzyme to a number of companies in China, Europe and the US besides having 90 percent market share in India. CBL is also producing and exporting Lovastatin and Tacrolimus to Europe and other countries. It is also starting the production of Simvastatin and Pravastatin in its newly US FDA approved facility in Gujarat. The company has put up a state-of-the-art manufacturing facility, which is located at Ahmedabad, Gujarat, and is spread over about 28-acre of land  for the production of hypolipemic agent Lovastatin, Pravastatin and Simvastatin. It has a dedicated facility for the production of Tacrolimus, an immunosuppressant. This apart, CBL has a well-equipped facility not only for the fermentation but also for the recovery and the powder processing areas. Concord has the largest shake flask capacity in India, where the wild strains can be manipulated by conventional mutation programs by a team of trained scientists. Concord undertakes the custom synthesis projects in biotechnology area too.  ]]> <![CDATA[Ocimum creates niche with bioinformatics services]]> https://biospectrumindia.com/news/95/1719/ocimum-creates-niche-with-bioinformatics-services.html https://biospectrumindia.com/news/95/1719/ocimum-creates-niche-with-bioinformatics-services.html Tue, 09 Jun 2009 14:49:00 +0530 Ocimum creates niche with bioinformatics services Ocimum Biosolutions is an integrated life sciences R&D, enabling companies providing focused solutions for different steps of the genomics process chain. After joining hands with Gene Logic, Ocimum Biosolutions offers a strong bioresearch portfolio including knowledge bases in genomics and solutions in toxicogenomics, pharmacogenomics and clinical genomics. Through the BioIT division, Ocimum provides expertly trained lab information management solutions for life sciences, niche bioinformatics services and products for genomic research such as gene expression analysis, advanced statistical analysis, gene function analysis, genome annotation, sequence comparison and EST analysis. The BioMolecules division produces microarrays and oligonucleotides. The Microarray division has been acquired from MWG Biotech, Germany and produces catalog OciChip arrays, custom OciChip arrays and offers microarray hybridization services. The oligonucleotides division, which has been acquired from Isogen Lifescience, Netherlands, makes standard and modified DNA, RNA oligonucleotides. Ocimum Biosolutions has recently introduced a microarray-based test (research use only) for the latest version of the H1N1 flu. The microarray was developed on Ocimum’s custom OciChip array platform three years ago when the first case of the avian flu outbreak occurred.  This has been updated with the latest sequence information posted last week and the probes have been redesigned.  This test will be available for use after completion of validation.  Ocimum also provides an RT-PCR-based molecular diagnostic assay for use in India and Asia. In line with its strategic objective to build a global network of service centers in close proximity to leading genomics researchers, Ocimum Biosolutions have launched genomic services on Affymetrix platform from Europe. Initially Ocimum will service gene expression studies on the Affymetrix platform from its facility at IJsselstein, The Netherlands. Within a couple of months, it will launch the entire bouquet of services from its IJsselstein facility. The company has been awarded with two US patents one for its proprietary system and method for determining matching patterns within gene expression data and determining renal toxins and one US patent for molecular toxicology modeling to elucidate global changes in gene expression and identification of toxicity markers in tissues or cells exposed to a known renal toxin. The invention includes a database of genes characterized by toxin-induced differential expression that is designed for use with microarrays and other solid-phase probes.   ]]> <![CDATA[Bharat Serums emphasizes on novel products]]> https://biospectrumindia.com/news/95/1667/bharat-serums-emphasizes-on-novel-products.html https://biospectrumindia.com/news/95/1667/bharat-serums-emphasizes-on-novel-products.html Tue, 09 Jun 2009 14:46:00 +0530 Bharat Serums emphasizes on novel products Bharat Serums and Vaccines manufactures and markets biological, pharmaceutical and biotechnology products and  is now looking at European market for its expansion. The past fiscal saw  Bharat Serums  and Vaccines (BSV) remaining stable and clocking the same annual revenues of Rs 140 crore for fiscal 2007-08. The company manufactures and markets biological, pharmaceutical and biotechnology products and  has in its portfolio over 25 brands. Its product range includes plasma derivatives, monoclonals, equine antitoxins and serums, cardiovascular, antimicrobials, antifungals, anaesthetics and hormones. Over the years, BSV has given emphasis to its R&D  operations both in India and overseas. The company has three distinct R&D divisions  working extensively on novel drug delivery system (NDDS), bioetchnology and equine products. In 2008, BSV announced that it has developed a novel formulation of Docetaxel which is free from surfactant Polysorbate-80. This formulation could potentially be a breakthrough in avoiding the fluid retention/hypersensitivity and extravasation reactions which are associated with Taxotere. Initial preclinical studies have shown a higher safety and a superior pharmacokinetic profile when compared to Taxotere. Efficacy in tumor bearing mice has also been established for the newly developed formulation. Taxotere, a branded formulation of Docetaxel, is marketed by Sanofi Aventis with global sales of more than Rs 13,624 crore ($2.9 billion). BSV had earlier developed a novel liposomal formulation of doxorubicin for which it tied up with a leading Indian pharmaceutical company. Recently, BSV has entered into licensing agreement with Actavis, one of the world’s leading generic pharmaceutical companies for an anti-infective product. BSV is in exploratory discussions with pharmaceutical companies for collaboration in commercializing the novel formulation of Docetaxel for various worldwide markets. BSV, one of the top ten Indian biopharmaceutical companies, has entered into an exclusive licensing , manufacturing and supply agreement with Actavis for marketing of one of its anti-infective generic formulations. Under the terms of the agreement, BSV will develop and manufacture the product for marketing by Actavis in Europe, Australia, South Africa and Turkey. The product is a sterile lyophilized injection that pose significant technological and regulatory challenges. The total worldwide sales of the product are close to Rs 1,408 crore ($300 million). BSV and Actavis will be working closely together to obtain the marketing authorization in Europe and other countries. ]]> <![CDATA[Lilly Pursues targeted therapy]]> https://biospectrumindia.com/news/95/8183/lilly-pursues-targeted-therapy.html https://biospectrumindia.com/news/95/8183/lilly-pursues-targeted-therapy.html Tue, 09 Jun 2009 13:38:00 +0530 Lilly Pursues targeted therapy Eli Lilly has been ranked as the one of the best companies to work for and it has been consistently progressing at par with the market growth. Eli Lilly and Company (India) Pvt Ltd is a 100 percent subsidiary of US pharmaceutical major, Eli Lilly. In India, the company enjoys formidable presence in diabetes, cardiology, women’s health, oncology and critical care. The company derives around 60 percent of its revenues from the diabetes segment. Some biotech products of the company include Forteo (Teriparatide), Huminsulin (Human Insulin), Humalog (Human Insulin analog), Byetta (Exenatide), Xigris (Drotrecogin Alfa) and Humatrope (Somatropin). The company clocked revenues of Rs 164 crore in the fiscal year 2008-09 as against Rs 137 crore in 2007-08, thereby clocking a growth rate of 10 percent over 2007-08, in line with the market growth as per ORG IMS. Within the diabetes care segment, the analog segment registered the highest growth compared to other insulin players. The company today enjoys a share of approximately 20 percent in the overall insulin market. In September 2008, the company launched a line extension (100 mg variant) of its premier anti-cancer agent Alimta (Pemetrexed). Moving forward, the company remains focused on pursuing the targeted therapy approach. Elaborating on it,  Sandeep Gupta, managing director, Eli Lilly India, said, “Development in research has helped scientists identify specific molecular targets within individual cells, thereby heralding an era of targeted therapy, a concept which Lilly has embodied. This technique enables companies like Lilly to tailor treatment options for individual patients based upon the presence of these molecular targets. This eventually leads to improved treatment procedures for patient.” This approach is clearly aligned with the Lilly vision. A case in point is the recent launch of Alimta in first line management of non-small cell lung cancer, but only of the non-squamous type. Lilly focuses on bringing best-in-class products through its own research stable or via collaborations. In October 2008, Lilly and Jubilant Organosys formed a 50:50 joint venture (JV) to develop molecules in areas of oncology, diabetes and cardiovascular diseases. Both companies agreed to invest Rs 37.69 crore over the next three years in the JV. In the same vein, March 2009 saw Lilly enter into another R&D alliance with Zydus Cadila, this time in the area of cardiovascular research. While Zydus will work to discover and develop potential molecules against a novel target, Lilly will provide chemical starting points and expertise and feedback on toxicology and ADME. The deal is reported to be worth Rs 1,413 crore. The company was recently ranked ninth in the ‘Best Companies to work for’ survey conducted by the BT-TNS-Mercer. With this recognition the company earns  the unique distinction of becoming the only pharma company that entered the list. Commenting on the recognition, Sandeep Gupta said, “This ranking is also a reflection of our continuous employee engagement initiatives throughout the year. We will continue to look at alliances and partnerships where products and services synergistically complement each other,” he added.  ]]> <![CDATA[Mahyco continues to revolutionize transgenic crop adoption]]> https://biospectrumindia.com/news/95/2680/mahyco-continues-to-revolutionize-transgenic-crop-adoption.html https://biospectrumindia.com/news/95/2680/mahyco-continues-to-revolutionize-transgenic-crop-adoption.html Tue, 09 Jun 2009 13:37:00 +0530 Mahyco continues to revolutionize transgenic crop adoption Mahyco was the first company in India to commercially grow and market transgenic Bollgard Cotton in 2002. It is ushering the Bt revolution in Indian agriculture through Bt brinjal now. Maharashtra Hybrid Seeds Company Limited (Mahyco) clocked an annual revenue of Rs 211.12 crore in 2008-09 as against Rs 170 crore in 2007-2008.  During the fiscal, Mahyco also sold 11,70,341 packets of Bollgard I and 19,06,234 packets of Bollgard II. Total area covered by Mahyco came up to 25.64 lakh acre bringing within it a total number of 77.70 lakh farmers. Mahyco is a private sector seed company and played a pioneering role in the use of hybrids during the Green Revolution of the mid 1960s and 1970s. Founded in 1964 by an entrepreneur, Dr BR Barwale who is now the chairman of the company, Mahyco is currently engaged in research, development, production, processing and marketing of 115 products in 30 crop species, including cereals, oilseeds, fibre crops and vegetables. It has to its credit 21 notified varieties. Worldwide, Mahyco was the first company to successfully commercialize F1 hybrid cotton based on genetic and cytoplasmic male sterility systems. Mahyco was also the first company in India to produce and market hybrid sorghum, pearl millet and sunflower.  At present,  Mahyco is also developing genetically enhanced crops with the use of gene transfer technology and has a partnership with Monsanto as well as a multi-crop, multi-licensing agreement with several research organizations both in India and abroad, for bringing agricultural and environment improvement technologies to South Asia. The company has a state-of-the-art R&D center near Jalna in Maharashtra, with ongoing hybrid breeding programs in over 30 crop species and support programs in plant pathology, entomology, cytogenetics, biochemistry, tissue culture, rapid cycling, and various other areas of biotech and transgenic plant research. The company has invested nearly Rs 47.12 crore ($10 million) for the R&D infrastructure and spends Rs 11.78 crore ($2.5 million) annually for research. In 1997, Mahyco was awarded the ISO-9001 certification for product development, production and processing. Over the past year, Mahyco has worked on bringing fruit and shoot borer (FSB)-resistant Bt brinjal closer to commercial release, and also on developing and testing herbicide-tolerant cotton, incorporating Monsanto’s Roundup Ready technology. It had also released its Bollgard-II technology of which they had acheived significant volumes. Bt brinjal, expressing the cry1Ac gene, has been in development and testing since 2000. Mahyco has completed a biosafety dossier encompassing environmental and food/feed safety tests on a variety of animal models including rats, rabbits, chicken, fish, goats and cows. ]]> <![CDATA[Syngene focuses on innovating R&D services]]> https://biospectrumindia.com/news/95/2304/syngene-focuses-on-innovating-rd-services.html https://biospectrumindia.com/news/95/2304/syngene-focuses-on-innovating-rd-services.html Tue, 09 Jun 2009 13:35:00 +0530 Syngene focuses on innovating R&D services Syngene International, a subsidiary of the biopharma major, Biocon, is a leading player in custom research. Syngene International Private Limited (Syngene) along with its clinical services arm has clocked revenues of Rs 224.60 crore in fiscal year 2008-09 as against Rs 160 crore in 2007-08. Syngene conducts high value R&D in early stage drug discovery and development for a diverse global clientele. From early stage discovery and process development through to cGMP manufacturing, Syngene provides customized R&D services to pharmaceutical and biotechnology companies on a strong platform of confidentiality and intellectual property protection. Established in 1994, Syngene was India’s first custom research organization to receive special export status by the Government of India. Over the past 14 years, the company has successfully partnered with leading players in the global pharmaceutical industry across a range of challenging programs, from discovery to supply of complex development compounds. Syngene, since inception, has developed skills in synthetic chemistry and molecular biology, process chemistry and cell line services. The company is also leveraging the convergence of IT and biotech. In 2007, Syngene entered into a research partnership with Bristol-Myers Squibb (BMS). Through this partnership, the company provides R&D services for discovery and early drug development to BMS. In same partnership Syngene opened a fully-dedicated research and development facility for Bristol-Myers Squibb in Biocon Park, Bangalore. The 2,00,000 sq.ft. facility at Biocon Park, dedicated to help advance Bristol Myers Squibb’s work in discovery and early drug development, is currently occupied by 270 scientists. The facility will house 360 scientists by the end of the year and could accommodate as many as 450 scientists in future. In another development, Syngene International has deepened its relationship with DuPont Crop Protection and signed up as its alliance partner. The company will now cover a broad range of R&D technical capabilities to support DuPont’s discovery pipeline. Already a research service provider to DuPont in discovery chemistry and biology, Syngene will now provide integrated research services through its One Box model.  ]]> <![CDATA[Indian Immunologicals focus on infrastructure expansion]]> https://biospectrumindia.com/news/95/7137/indian-immunologicals-focus-on-infrastructure-expansion.html https://biospectrumindia.com/news/95/7137/indian-immunologicals-focus-on-infrastructure-expansion.html Tue, 09 Jun 2009 13:25:00 +0530 Indian Immunologicals focus on infrastructure expansion Indian Immunologicals with a range of flagship products in the animal health market has become the largest animal health brand in India. The National Dairy Development Board (NDDB) sets up Indian Immunologicals Ltd (IIL) in 1982 with the objective of making foot and mouth disease (FMD) vaccine available to farmers at an affordable price. Subsequently, IIL has developed many biologicals through its own R&D efforts and launched several vaccines in the Indian market at affordable prices. IIL is today a market leader in veterinary biologicals in India. It operates one of the largest plants in the world for veterinary vaccines and is WHO-GMP and ISO-9001 certified. IIL exports its products to several countries and exports contribute substantially to the company’s turnover. IIL is the largest player in veterinary vaccine market in India with a depth in marketing throughout the country, reaching out to the smallest of livestock keepers. Many of its products enjoy strong patronage from veterinarians and as a result, occupy the top slots in market share. IIL has a range of vaccines for cattle, sheep and canine segments, combined with its presence in the formulations segment, IIL holds the third position in the Indian animal health market. IIL posted a biotech sales turnover of Rs 231.46 crore for the fiscal year ended March 2009 as against Rs 196 crore in 2007-08. The company expects to cross the Rs 300 crore revenue mark by 2010. IIL currently employs 1,187 people and plans to hire another 150 in the coming year. The company has invested more than Rs 30 lakh in 2008 and plans to triple this amount by next year, mainly in R&D and infrastructure. IIL’s flagship product in the animal health market is its Raksha FMD vaccine, which is the largest animal health brand in India. IIL meets more than 80 percent of the requirement of the vaccine in India. With a large repository of various FMD virus strains maintained in the laboratory, IIL is able to provide FMD vaccines of customer’s choice and as per epidemiological requirement for other countries. IIL is one of the main suppliers of FMD vaccine to FAO. IIL is also a major player in the human vaccine market in India, especially in the pediatric vaccine and the rabies product segments. In the human vaccine market, IIL holds the fourth position. IIL exports its products to several countries and exports contribute substantially to the company’s turnover. Future Plans: The company has acquired 50 acre of land in Biotech Park – Phase III near Karkapatla to locate its new manufacturing facilities for animal vaccines, health formulations and human vaccines. These facilities will be ready for commercial production by mid 2011.  ]]> <![CDATA[Bharat Biotech adopts multi-dimensional business model]]> https://biospectrumindia.com/news/95/4076/bharat-biotech-adopts-multi-dimensional-business-model.html https://biospectrumindia.com/news/95/4076/bharat-biotech-adopts-multi-dimensional-business-model.html Tue, 09 Jun 2009 13:16:00 +0530 Bharat Biotech adopts multi-dimensional business model Bharat Biotech has made significant strides in manufacturing and commercializing vaccines for immunization programs worldwide. Bharat Biotech International Ltd (BBIL) has achieved an annual turnover of Rs 234.13 crore in 2008-09 as against Rs 126 crore in 2007-08 and the company is expecting to touch Rs 300 crore in the year ahead. Bharat Biotech has evolved as a multi-dimensional biotechnology company specializing in product-oriented research, development and manufacturing of vaccines and biotherapeutics. Hyderabad-based Bharat Biotech is one of the largest manufacturers of INDIRAB (anti-rabies vaccine) in India. Bharat Biotech is a WHO prequalified manufacturer of REVAC-B (hepatitis-B vaccine) for supply to UNICEF and the only vaccine company in India to manufacture and supply a preservative (thiomersol) free vaccine, REVAC-Bmcf. Bharat Biotech has developed a 3-dimensional business model with emphasis on biogenerics, contract manufacturing and research for developing novel products. This strategy has given Bharat Biotech the ability to earn revenues in the short and medium term while focusing on novel patent protected products that are  much needed by the developing world. Bharat Biotech has shown significant progress in new product development and has partnered with companies from the US and Europe to co-develop, manufacture and market the products. Bharat Biotech has built productive partnerships with companies, such as Wyeth and Agennix. Bharat Biotech is one of the first companies in India to perform contract manufacturing of vaccines for global major like Wyeth, due to the IPR associated with its Hib vaccine. Other major partnerships of Bharat Biotech are with the Department of Biotechnology, Government of India; PATH; US Centers for Disease Control and Prevention (CDC); Stanford University; US National Institutes of Health, National Institute of Allergy and Infectious Diseases (NIAID); Society for Applied Studies; National Institute of Immunology; Indo-US Vaccine Action Program; International Center for Genetic Engineering and Biotechnology (ICGEB), Thrombogenics and All India Institute of Medical Sciences. Bharat Biotech is also now focused on developing several technology parks. According to Dr Krishna Ella, chairman and managing director of Bharat Biotech, the company’s task is to development core infrastructure and technology to enable establishment of new companies whereby new local entrepreneurs in the biotechnology field will be created.  ]]> <![CDATA[Jubilant leverages on collaborations]]> https://biospectrumindia.com/news/95/1119/jubilant-leverages-on-collaborations.html https://biospectrumindia.com/news/95/1119/jubilant-leverages-on-collaborations.html Tue, 09 Jun 2009 13:14:00 +0530 Jubilant leverages on collaborations Partnerships are the key to drug discovery and this seems to be a recurring theme for Jubilant Organosys over the last year which saw collaborations with companies such as Lilly and Astra Zeneca. Jubilant Organosys Ltd is an integrated pharmaceutical industry player that provides custom research and manufacturing services (CRAMS) and drug discovery and development services. Jubilant Organosys focuses on the pharmaceutical value chain for products and services such as exclusive synthesis, contract manufacturing, proprietary products, active pharmaceutical ingredients, generic dosage forms, drug discovery services, drug development services, chemistry services, clinical research services, steriles, non-steriles and radiopharmaceuticals. Jubilant Organosys has five subsidiary companies in India that includes Jubilant Biosys Ltd for discovery informatics and drug discovery services; Jubilant Chemsys Ltd for medicinal chemistry; Clinsys Clinical Research Ltd for clinical research and bioavailability or bio equivalence studies; Jubilant First Trust Healthcare Ltd for high quality healthcare services and Specialty Molecules Pvt Ltd for niche expertise in continuous vapor phase halogenations reaction. Jubilant has signed several R&D deals in 2008. In July 2008, Jubilant Biosys Ltd., Bangalore and Amgen Inc, Thousand Oaks, California, had announced a drug discovery partnership to develop a portfolio of novel drugs in new target areas across multiple therapeutic areas. Jubilant will be engaged in the development of early preclinical candidates from Amgen’s early discovery efforts for an initial term of three years, Amgen will have the responsibility for the subsequent preclinical and clinical development and their commercialization. Amgen will retain/own the drugs developed in collaboration with worldwide commercialization rights. Commenting on the development, Shyam S Bhartia, chairman and managing director and Hari S Bhartia, co-chairman and managing director of Jubilant Organosys said, “We are very pleased to expand our relationship with Amgen. This collaboration leverages the innovation capabilities of Jubilant Biosys in pharmaceutical discovery and preclinical development. ” In October 2008, Jubilant Organosys entered into an agreement with Eli Lilly India to form an equally-owned joint venture in India focused on providing drug development services exclusively to Jubilant and Eli Lilly partnered molecules. The joint venture based out of Bangalore is focusing on preclinical molecules and their development through phase-II clinical trials, before returning successful assets to the sponsors for further development. In May 2009, Jubilant has signed a research collaboration agreement with AstraZeneca, focuses on delivering novel drug candidates into its preclinical pipeline. Jubilant focus on flexible and hybrid platform of innovative discovery chemistry, biology and insilico services demonstrates its ability to customize and accelerate global drug discovery efforts led the company to clock Rs 242 crore in revenues from the services business.” ]]> <![CDATA[Shantha marches ahead with new launches]]> https://biospectrumindia.com/news/95/2263/shantha-marches-ahead-with-new-launches.html https://biospectrumindia.com/news/95/2263/shantha-marches-ahead-with-new-launches.html Tue, 09 Jun 2009 13:13:00 +0530 Shantha marches ahead with new launches Shantha Biotechnics’ commitment to breaking new ground in modern biotechnology to address critical healthcare needs of the developing world was further consolidated in 2008-09. Shantha Biotechnics, which is part of the Merieux Alliance Group, logged an estimated Rs 250 crore turnover during fiscal year 2008-09 up from Rs 150 crore the previous year. A pioneer in the field of biotechnology, Shantha Biotechnics is the first Indian company to develop, manufacture and market a recombinant human healthcare product in India. Shantha is currently focusing its R&D efforts on the development of generic biologicals, novel therapeutic antibodies, proteins and vaccines. The company conducts exploratory research in the fields of oncology, infectious diseases and platform technologies. Shantha Biotechnics has recently launched the oral cholera vaccine, Shanchol. “The company has spent about Rs 4.72 crore to set up facilities. Initially 50 lakh doses are planned. It is the first among more than a dozen vaccine projects which has reached commercial scale, supported by the Bill Gates Foundation,” stated Dr KI Varaprasad Reddy, managing director of Shantha. “The vaccine would be priced at Rs 300 a dose. It would be commercially available in the country from June 2009. The only other WHO approved oral cholera vaccine available is Dukoral, a Swedish vaccine, which costs about Rs 1,885 and is difficult to administer, especially in public health setting,” Dr Varaprasad Reddy added. Shantha Biotechnics has got enquiries from Bangladesh and Zimbabwe for the supply of bivalent oral cholera vaccine. Supplies are to be routed through the Gates Foundation. The WHO prequalification would be obtained in a couple of months. Shanvac-B is the first Indian hepatitis-B vaccine to be pre-qualified by WHO, Geneva, for supplying to the UN agencies globally. Today, Shantha caters to major international markets including Asia Pacific, Africa, Commonwealth of Independent States (CIS) and Latin America in addition to the United Nations Children’s Fund (UNICEF) and the Pan American Health Organization (PAHO). Shantha has also obtained WHO pre-qualification for its combination vaccine of DPT+ hepatitis-B vaccine, Shantetra, enabling supplies to the UN agencies. The company is currently working on therapeutic monoclonal antibodies and pegylated proteins. French healthcare company, Merieux Alliance, has about 60 percent stake in Shantha Biotechnics. Merieux bought the stake from Oman-based financial firms, which had invested in Shantha a few years ago. This alliance favors synergies in terms of research and clinical development between the group companies. Shantha Biotechnics also has access to the support provided by Merieux Alliances international network. The contract research work undertaken so far has been in the areas of gene cloning, monoclonal antibody development, expression and purification of recombinant proteins by fermentation, fermentation and purification process optimization, development of polyclonal antibodies, development of WCB and MCB and analytical methods. ]]> <![CDATA[Novozymes intensifies enzyme proliferation]]> https://biospectrumindia.com/news/95/1078/novozymes-intensifies-enzyme-proliferation.html https://biospectrumindia.com/news/95/1078/novozymes-intensifies-enzyme-proliferation.html Tue, 09 Jun 2009 13:02:00 +0530 Novozymes intensifies enzyme proliferation With the acquisition of Biocon’s enzyme business, Novozymes South Asia has become prominent player in the industrial enzyme market and has innovative plans for future. Bangalore-based Novozymes South Asia has registered estimated revenues of Rs 250 crore for the year 2008-09. With the acquisition of Biocon’s enzyme business, the company had recorded high sales of Rs 225 crore last year. The company presently holds 65-70 percent share in the industrial enzymes market. In textiles it holds a 90 percent share followed by a number of formulators in the country and in starch again it has a 90 percent share. Novozymes has sales offices and R&D facility across the country. Novozymes’ business in Asia has grown significantly in recent years – with detergent, textile and beverage alcohol also being its target industries. The acquisition of Biocon Limited’s enzyme activities has been an important step for Novozymes in its  efforts to increase sales in new markets. The acquisition has given the company a strong distribution network and good knowledge of the local market, which would have taken a long time to build. With this Novozymes has also acquired better research facilities in India, which allows the company to demonstrate its products to customers. Novozymes has had a presence in the Indian market for a long time. The first enzyme activities were established in Bangalore in 1983. Novozymes’ Indian headquarters is in the International Technology Park, but the production and repackaging facilities are at other locations in the city. With 150 employees from Biocon, the company now has about 200 employees in India. They work within research and development, sales, production, finance and IT. Novozymes has gradually increased its activities and asset base in India. Novozymes is the world’s largest and most diversified provider of industrial biotechnology, pioneering the replacement of chemicals with enzymes in a broad range of industries such as laundry detergents, animal feed and the biofuel industry. Novozymes has set up new laboratory, repacking and office facilities in Bangalore, thereby establishing  R&D operations in India in a big way for the first time. The R&D unit in India will initially focus on optimizing enzyme properties, and application development. Novozymes spends about 13 percent of its turnover on R&D. And around one-tenth of its expenditure on R&D is used in new areas, in line with its strategy of building up new business areas beyond enzymes and micro organisms. By 2010, the company aims to produce second-generation bioethanol that converts waste and agricultural residues into energy. This will be a radical development in the search for new renewable energy sources. The company’s long term plan is to get closer to some of the research institutes in developing certain applications relevant to the local market. In this contexy, t-he company is watching biofuels and biodiesel areas very closely.  ]]> <![CDATA[Nuziveedu focuses on network expansion]]> https://biospectrumindia.com/news/95/2145/nuziveedu-focuses-on-network-expansion.html https://biospectrumindia.com/news/95/2145/nuziveedu-focuses-on-network-expansion.html Tue, 09 Jun 2009 12:53:00 +0530 Nuziveedu focuses on network expansion Nuziveedu Seeds’ hybrid seeds are produced in collaboration with about 42,000 seed producing farmers and are used by 50 lakh farmers across the country. Nuziveedu Seeds Ltd (NSL), one of the leading hybrid seed companies in India has posted an annual turnover of Rs 363.96 crore from its biotech products for the year 2008-09. The company has sold 65 lakh packets of Bt cotton seeds in 2008-09 as against 48 lakh packets in the year 2007-08. NSL aims to cross Rs 500 crore mark by 2010. Cotton seeds supplied by the company are planted in 35-40 percent of the cotton area in the country and contribute in producing 40-45 percent best quality cotton in India. The company’s R&D wing has evolved excellent hybrids in cotton, Bunny and Mallika, which produce very high quality cotton fiber besides giving high yield to farmers. It has also evolved several excellent hybrids of rice, maize, bajra and jowar. The company has also invested in renewable power generation, textiles, cotton procurement and trading, sugar, power and IT infrastructure businesses. NSL has established all the required research farms, seed conditioning (processing) facilities as well as conditioned storage godowns for seeds around Hyderabad and several other strategic locations across the country.  The company has got presence in about 15 major agricultural states with offices at Hyderabad, Delhi, Guntur, Ahmedabad, Akola, Indore, Davangere, Bangalore, Chennai, Lucknow, Jaipur and Patna. The company has also developed excellent systems of production, quality assurance and distribution, because of which it is able to maintain its leadership position in the country. After establishing itself as the top player in cotton, NSL is now working on increasing its market share in rice, maize, jowar, bajra, sunflower, chillies, soybean, wheat and various vegetable crops. At present NSL is using the GM traits for imparting insect resistance in cotton and selling the largest quantity of Bt cotton seeds in India. NSL Cotton Corporation (NCC) is part of Nuziveedu Seeds Group that carries out activities related to the business of managing cotton cultivation, procurement, processing and marketing as branded cotton. Some of the important products from the company include Cotton (non- Bt & Bt 1 and Bt 2 Hybrids). Other crops mainly include maize, jower, bajara, paddy, sunflower and vegetables. The company has also been offering  extention services to the farmers through farmers education program, regarding the package and practices of diffrent crops, plant protection measures, fertilizer application etc. New initiatives in the area of biotechnology include drought tolerance research in cotton in collaboration with ICGB, new Bt gene in collaboration with University of Agricultural Sciences (UAS), Bangalore and Indian Institute of Technology (IIT), Kharagpur. NSL is also developing GM traits on its own and through contract research for cotton and other crops. ]]> <![CDATA[Rasi takes the next step forward]]> https://biospectrumindia.com/news/95/2446/rasi-takes-the-next-step-forward.html https://biospectrumindia.com/news/95/2446/rasi-takes-the-next-step-forward.html Tue, 09 Jun 2009 12:51:00 +0530 Rasi takes the next step forward Rasi has done extensive research for crop improvement by incorporating latest technology in breeding techniques and is aiming for hybrids with early yield, high quality and drought tolerance. Tamil Nadu-based Rasi Seeds has posted sales of Rs 375.59 crore from its biotech products for the year 2008-09 as against Rs 293.26 in the year 2007-08. The company has sold 55.21 lakh packets of Bt cotton in 2008-09 as against 50.5 lakh packets of Bt cotton in 2007-08 and has expanded the area under Bt cotton cultivation to 40 lakh acre. Rasi Seeds was envisioned by M Ramasami, and was initiated in the year 1973 in Attur near Salem. Since its inception, Rasi Seeds has undergone rapid development from a seed production and supply venture to a commendable position in research and development. Rasi Seeds aims to create genetic variability in cotton seeds to suit various agro-climatic zones by producing cotton hybrids of various staple length and abiotic stress tolerance.The company has a well maintained research farm of 140 acres, which includes facilities like greenhouse, separate ginning facility for germplasm and other breeding lines, state-of-the-art fiber testing lab, well-equipped seed testing laboratory and separate dehumidified refrigerated facility for germplasm and breeding lines. The company also has modern biotech facility for testing the presence of Bt gene. Rasi Seeds has recently built a new state-of-the-art biotechnology facility and crop breeding facility at Attur, near Salem in Tamil Nadu with an investment of about Rs 10 crore. The new R&D facility has laboratories for biotech research, crops research, germplasm conservation, insect bioassay laboratory, library and documentation, and other facilities in an area of 40,000 sq. ft.  The company has created excellent and modern facilities for undertaking crop biotech research with dedicated and proficient scientific staff. A new transgenic greenhouse following the biosafety guidelines of the Department of Biotechnology has also been created. The R&D center also has a plant molecular biology laboratory for carrying out crop biotechnology activities, a tissue culture facility to undertake genetic transformation of desirable genes in crops is fully functional. Dr M Ramasami, managing director, Rasi Seeds said, “The future thrust of our center would be on marker-assisted selection using DNA markers for several important traits in crops such as rice, wheat, cotton and vegetables. This will involve integration of crop breeding and biotechnology including bioinformatics. We will also intensify our transgenic research in different field crops and vegetables for agronomically important traits besides quality traits.” Some of the ongoing projects of the company include sourcing and evaluation of breeding germplasm lines with earliness, erect leaves, high per se and orange flint and orange yellow semi dent grain colours. ]]> <![CDATA[Innovation on a global scale]]> https://biospectrumindia.com/news/95/2323/innovation-on-a-global-scale.html https://biospectrumindia.com/news/95/2323/innovation-on-a-global-scale.html Tue, 09 Jun 2009 12:50:00 +0530 Innovation on a global scale Panacea Biotec, a pre-qualified supplier of OPV and Hep-B vaccines to UN agencies also has WHO pre-qualification for its pentavalent vaccines. Panacea Biotec is one of India’s leading research-based health management companies with established research, manufacturing and marketing capabilities. The product portfolio of the company includes vaccines, biopharmaceuticals and prescription products in important therapeutic areas such as pain management, diabetes management, renal-disease management, anti-osteoporosis, anti-tubercular and gastro-intestinal care products.     The company registered a net turnover of Rs 831.55 crore in 2008-09. The total biotech revenue stood at Rs 597.14 crore as against Rs 678.41 crore previous year, while the vaccine segment registered net revenue of Rs 547 crore as compared to Rs 636 crore in 2007-08. In July 2008, Panacea Biotec received WHO pre-qualification for its fully liquid innovative combination pentavalent vaccine, Easy five, which resists against five deadly infectious diseases (DTwP+ Hep B+ Hib) of early childhood. EasyFive (Pentavalent) vaccine is available in different markets with antigens used from different sources. Panacea  had earlier received pre-qualification by WHO for two other combination vaccines, EasyFour (DTP + Hib) and Ecovac (DTP + Hep B). In a notification, WHO has advised the UN procuring agencies regarding the acceptability of these vaccines worldwide. Panacea Biotec is already a pre-qualified supplier of OPV and hepatitis-B vaccines to UN agencies. This makes Panacea Biotec one of the first few companies in the world to have been pre-qualified by WHO for a pentavalent vaccine. The company also received an award notification from UNICEF for supply of its pentavalent vaccine. While commenting on the achievement, Rajesh Jain, JMD, Panacea Biotec, said, “There is an urgent need to foster innovation for the developing countries as the world is inching closer to the goal of eradicating dreadful diseases, especially for the early childhood, by providing effective vaccines. Immunization can prevent a million deaths. We at Panacea Biotec are partners with agencies worldwide to accelerate and spearhead a wide spectrum of technological innovations to develop vaccines that meet the unique needs of low-resource countries In October last year, the company entered into a strategic alliance with PharmAthene, Inc., US, a biodefense company developing medical countermeasures against biological and chemical threats, that includes a strategic equity investment to the tune of Rs 61.72 crore, in exchange for the purchase of common stock and warrants in PharmAthene.  ]]> <![CDATA[Biosecurity of transgenic Bt technology]]> https://biospectrumindia.com/news/95/1029/biosecurity-of-transgenic-bt-technology.html https://biospectrumindia.com/news/95/1029/biosecurity-of-transgenic-bt-technology.html Tue, 09 Jun 2009 12:03:00 +0530 Biosecurity of transgenic Bt technology Biosecurity issues raised to oppose GE crops by anti-tech activists are relevant even to products of classical agricultural biotechnology, but were never made an issue in that context. -C Kameswara Rao, Foundation for Biotechnology Awareness and Education, Bangalore krao@fbae.org In the context of modern agricultural biotechnology the term biosecurity has two components, biosafety, the safety of genetically engineered (GE) organisms and/or their products to humans and animals as food, feed and medicine; and environmental safety, the safety of non-target organisms, soil and water.  The terms biosecurity and biosafety are often used incorrectly as synonyms.   Biosecurity issues raised to oppose GE crops by anti-tech activists are relevant even to products of classical agricultural biotechnology, but were never made an issue in that context.   It was the international scientific community, not the anti-tech activists, who have identified the possible biosecurity risks from the transgenic crops and devised testing and mitigation protocols. Science has reasonable peer reviewed experimental evidence to answer biosecurity concerns. The regulatory process in every country ensures that all questions are answered reasonably satisfactorily before commercialization is permitted. Most of those who raise biosecurity issues to voice their opposition to GE crops have no locus standi in terms of scientific knowledge and expertise to trash the combined global scientific wisdom. Biosafety of Bt Bt being a universally occurring soil bacterium, all species of plants and animals in agricultural and other situations, and those that use plants as food have been exposed to Bt and Bt proteins for centuries. Bt proteins are transient in the environment, the toxicity of Bt proteins is pest specific, dependent upon a set of biological pre-requisites.  The use of Bt as a conventional pesticide for over 60 years has demonstrated that it is safe to a variety of non-target organisms. Cry proteins were shown to be harmless to vertebrates, including mammals and humans, even at high doses, by ingestion, inhalation or injection. Toxicity and allergenicity Anti-tech activists raise issue after issue to brand GE crops as toxic.  Reports of the death of peacocks and the death of farm animals in Andhra Pradesh and honey bee colony collapse disaster in Europe and North America, were attributed to the presumed toxicity of Bt proteins in GE crops.  These incidents projected as major issues have been effectively shown to be due to causes other than Bt protein toxicity. Several claims have been made of allergenicity of transgenic crops, including Bt cotton in some places in India, but there has never been any scientific evidence. Impact of Bt on non-target organisms The much-brandished instance of toxicity of Bt proteins to non-target organisms was based on the study by Losey, et al.,  (Nature, 1999) who reported that transgenic Bt corn pollen harm monarch larvae, a conclusion immediately questioned by Hodgson (Nature Biotechnology, 1999).   Subsequently, Sears, et al., (2001) re-examined the issue, avoiding the flaws in the experimental design in the study of Losey et al., and concluded that impact of Bt corn pollen on monarch butterfly populations was not significant. A February 2008 publication indicates that Cry 1Ab Bt proteins do not affect the performance of bumble bees in any manner. In May 2008 Bt Cry1C proteins were shown to be safe to parasitoids that control pest populations in many crops, in contrast to the severe damage caused to the parasitoids by the traditional insecticides. How safe are Bt transgenics?  All the evidence indicates that Bt transgenics are very safe and over a decade’s cultivation of Bt transgenics has neither confirmed the scary scenarios aired by the critics nor has thrown up any new threats. Biosecurity issues are unfortunately often mixed up with political, economic, management, societal and ethical issues, emotionalizing and sensationalizing the concerns, to spread fear and suspicion of GE technology. ]]> <![CDATA[India's first swine flu Vaccine developer]]> https://biospectrumindia.com/news/95/1844/indias-first-swine-flu-vaccine-developer.html https://biospectrumindia.com/news/95/1844/indias-first-swine-flu-vaccine-developer.html Tue, 09 Jun 2009 12:03:00 +0530 India’s first swine flu Vaccine developer Pune-based Serum Institute of India has consolidated its #1 position in the country for the fifth year in a row. Serum Institute of India clocked a total sales revenue of Rs 1,114 crore for FY 2008-09 as against Rs 987 crore for FY 2007-08. Serum’s products have been supplied to international health agencies like the WHO, UNICEF and PAHO and to over 140 countries across the globe. Its vaccines are being used in the National Immunization Program’s of several countries. Measles and rubella virus vaccine is being used in catch-up and mop-up campaigns in several countries in their quest to control the incidence of measles and rubella. Serum Institute has the capacity to produce over 10 crore doses of vaccines. Serum Institute supplies  new age vaccine to Global Alliance for Vaccines and Immunization (GAVI), Pan American Health Organization (PAHO) and UNICEF. Serum Institute is one of the  manufacturers of Hib vaccine in India and is given to infants along with DPT or alone. Earlier efforts by UNICEF for Hib immunization met with little success as the prices were very high, which led to limited access of the vaccine in many poor countries. Serum Institute  supplies the Hib vaccine at a low price compared to the MNC prices. The vaccine is available  under the brand name,  SiiHIB Pro. From its inception, Serum Institute stressed upon R&D as an important focus area. It has invested significantly in R&D and these efforts are yielding results. Established in 1977, as a distinctly separate autonomous body, Serum Institute of India Research Foundation works with an objective of enhancing research in the fields of medical sciences and in natural and applied sciences. The foundation has several outstanding achievements to its credit; the document, information support for immunization programme in India, referred to by health planners of the Government of India while formulating the seventh Five-Year Plan, was researched and compiled by the foundation in 1984 and again in 1989. This was a computerized demographic study with 44 variables. Other notable successes were, pilot production of measles vaccine on human diploid cells; industrial column chromatography and affinity chromatography for separation of immunoglobulins; monitoring of quality of vaccines in the field; clinical trials of new products; clinical trial of human diploid cell rabies vaccine in laboratory workers. Serum has several milestone achievements to its credit. It  went into a partnership with Syracuse University (SU) and  has awarded $250,000 to a team of SU researchers led by Robert Doyle, assistant professor of chemistry in the College of Arts and Sciences, to develop new oral vaccines against tetanus and rotavirus, a severe form of diarrhea that affects infants and young children worldwide. Serum was also recently commissioned by WHO to develop a vaccine against latest strain of H1N1 flu virus. This development makes Serum one of the select few organizations in the world to have been commissioned to develop the vaccine by WHO. Vaccines against the H1N1 virus already exists, but, they are unlikely to be effective against the latest strain of the virus, which has already claimed many lives in the US and Mexico and has already hit India. Its scientists are working on developing the vaccine against the new strain of the deadly H1N1 influenza virus. Dr SD Ravetkar, senior director, Serum Institute of India, said, “The number of vaccine doses will depend on WHO’s needs and we will build our facility accordingly. They have not given any numbers as such and we are in the process of developing the vaccine.” Serum is also on the verge of launching its  meningitis vaccine. The company has invested about Rs 80 crore on this project. Dr Cyrus S Poonawalla, chairman and founder, Serum Institute of India, said, “This will be a landmark initiative for us because this is another vaccine which we are doing in collaboration with PATH, an international, nonprofit organization, especially for African countries and Haj tourists. We will be the only company in the country for years to come,with such a vaccine.”  The company now also has a focus on products beyond the vaccines. “We have ventured a little late into biopharmaceutical market and technology development took some time but as usual we will be able to adjust to the heavily competitive pricing. We are looking at some novel and innovative ways to develop biopharma drugs, the initiative was rolled out three years ago. The company is working on novel vaccines and also on Novel Drug Delivery System (NDDS) initiatives. This is a very niche area and the initial results that we have been getting for these vaccines are quiet encouraging,” said Dr Ravetkar. At present several other vaccines are under development like the the rotavirus  vaccines and monoclonal antibodies for rabies. Serum Institute has also got an approval from the US FDA for its oncology facility, the construction of which started in 2006 and would be fully commissioned in a few months time. A world-class facility for its pentavalent vaccines  has also been developed. Towards the end of 2008, Serum had hiked its holding in Panacea Biotec on October 14, 2008 through bulk deal at Rs 220 per share. Part of this equity stake was bought from South Korean asset management firm, Mirae. Serum Institute of India now has close to seven percent stake in the Delhi-based Panacea Biotec. This deal is significant as Serum Institute and Panacea are the top two Indian firms in the vaccine business. Serum Institute of India has also set up Serum Bio Pharma Park, India’s first biotech special economic zone (SEZ). This was inaugurated in 2006. The park is adjoining Serum Institutes’s existing manufacturing unit and is a sector-specific SEZ meant for biotechnology and pharmaceutical products. The SEZ will allow Serum Institute of India to avail various tax benefits such as income tax and import duty on capital goods. This has encouraged a lot of foreign companies to partner with Serum Institute of India to avail and share these benefits. The SEZ is located on 55 acres of area in Hadapsar, Pune. Serum Institute  will  have 5-6 units in the SEZ. The project is due to be completed by 2012-13 and Serum is investing close to Rs 1,200 crore on the project. This investments have been divided in various phases. The phase-I investment will be a minimum of Rs 500 crore. Serum Biopharma Park as developers would raise funds through internal accruals of the company as well as external borrowings from financial institutions. About 100 crore doses of various vaccines are expected to be produced on an annual basis from this special economic zone. The new zone would manufacture vaccines for pneumonia, rotavirus and combination vaccines for meningitis, influenza and Hib. Oncological products for the US and EU markets are also expected to be manufactured at the new facility. The premises have already been prequalified by WHO. Nayantara Som ]]> <![CDATA[Biotech Parks in India]]> https://biospectrumindia.com/news/95/8416/biotech-parks-in-india.html https://biospectrumindia.com/news/95/8416/biotech-parks-in-india.html Tue, 09 Jun 2009 11:35:00 +0530 Biotech Parks in India Shapoorji Pallonji Biotech Park, Secunderabad The Shapoorji Pallonji Biotech Park is a venture of Shapoorji Pallonji Group of companies, and is spread over 300-acre near Hyderabad, India. The park is located in the Genome Valley, India’s first state-of-the-art biotech cluster for life science research, training and manufacturing activities. Contact Head: P Gopal Krishnan, CEO Tel: +91-40-27900893, Fax: +91-40-27901428 E-mail: infobio@spbiotechpark.in, Website: www.spbp.co.in TICEL Bio Park, Chennai TICEL Bio Park was established in Chennai, in November, 2004. TICEL acts as a hub for biotech R&D industry in major domains of biotechnology such as medical biotechnology, nutraceuticals, agricultural biotechnology and bioinformatics. The tenancy area has 74 modules of 1,525 sq.ft each, available for clients to develop their own customized R&D labs. Contact Head: P Shanmugasundaram, CEO Tel.: +91-44-22542061/62, Fax: +91-44-22542055 E-mail: ticel@vsnl.net, md@ticelbiopark.com Website: www.ticelbiopark.com ICICI Knowledge Park, Hyderabad Launched by ICICI Bank Ltd, in partnership with the Government of Andhra Pradesh, the ICICI Knowledge Park is committed to facilitating business-driven research and development. ICICI Knowledge Park has developed as a world class center for leading-edge business driven research. It is recognized as the scientific and industrial research organization, and is entitled to full customs and excise duty waivers. Contact Head: Deepanwita Chattopadhyay, CEO Tel: +91-40-23480003, +91-9848030779 E-mail: deepanwita@icicikp.com,    Website: www.iciciknowledgepark.com Biotech Park, Lucknow Biotechnology Park, Lucknow, is a technology incubator that offers incubation and state-of-the-art infrastructure facilities to the start-up companies. The park has been approved as the Industrial Park. The park is now eligible for incentives and concessions under the Industrial Park Scheme, 2002, of the Government of India. Contact Head: Dr PK Seth, CEO Tel: +91-522-4012091, 4053004, 2733174, Fax: +91-522-4012081 E-mail: ceo.biotech@gmail.com, Website: www.biotechpark.org.in Agri Science Park, Hyderabad The Government of Andhra Pradesh has established the Agri Science Park (ASP) in collaboration with International Crops Research Institute for the Semi-Arid Tropics (ICRISAT) in December 2003. The mission of ASP is to emerge as a hub for public-private partnership to enhance the commercialization of scientific technologies and knowledge through market mechanisms for the benefit of the poor people. Contact Head: Abdul Rahman Ilyas,COO Tel: +91-40-30713697, 30713698, Fax: +91-40-30713074 E-mail: a.r.ilyas@cgiar.org, Website: www.agri-sciencepark.icrisat.org International Biotech Park, Pune International Biotech Park (IBP) is a public-private initiative to promote a premier life science research. The park is designed to meet the needs of biotech companies from India and abroad by providing lab space and land  with world-class infrastructure facilities that include a Bio-resource Center, built up space and developed land with commercial and other support facilities. Contact Head: Sandesh Sable, General Manager-Technical Tel : +91-20-66740704, +91-9881731735, Fax: +91-20-66740720 Website: www.ibpl.net.in Kinfra Biotech Parks, Kerala Kinfra Biotech Parks are the combination of  Technology Incubation Center (TIC) providing modules for R&D in biotechnology, pilot plant and a business enterprises zone (BEZ) consisting of developed plots to be utilized for setting up industrial units. Kinfra Biotech Parks are being developed at two locations, Thiruvananthapuram and Cochin, in Kerala with the areas of 25 acre and 50 acre respectively. Contact Head: S Ramnath, CEO Tel: +91-471-2726585, Fax: +91-471-2724773 E-mail: kinfra@vsnl.com, Website: www.kinfra.com Bangalore Helix, Bangalore Bangalore Helix, the biotech cluster being planned by the Karnataka government, aims to support biotech units with common infrastructure. The biotech incubator is coming up in an area of about 10-15 acres in the Biotech Park. Bangalore Helix offers incubation facility, common instrumentation facility, a business center, commercial and recreational areas, high-end computing facility, pilot plant, medical sample repository, gene bank etc. Contact Tel: +91-80-22280562, 22032434, Fax: +91-80-22288340, 22262450 E-mail: itsec@bangaloreitbt.in, Website: www.bangaloreitbt.in MITCON Biotech Park, Pune MITCON Biotechnology Center is jointly promoted by the Department of Science and Technology, Government of India, and Asia and Pacific Center for Transfer of Technology (APCTT), UN Organization. The park has a full-fledged laboratory, library and training facilities. The objective of the park is to develop agripreneurs in biotechnology and also to commercialize biotechnologies. Contact: Head: Ashish Wele, vice president, Mitcon Biotech Incubation Center Tel: +91-20-523 4456/58, Fax: +91-20-5533206 E-mail: mitconbiotech@rediffmail.com, Website: www.mitconfoundation.org Biotech Parks in Rajasthan Rajasthan State Industrial Development and Investment Corporation (RIICO) is developing biotech parks in Jaipur, Jodhpur and Chopanki. The state government is also encouraging the development of biotechnology parks in the private sector. It will consider extending concessions to such biotechnology parks on case-to-case basis. Contact Tel.: +91-141-5113201 Fax: +91-141-5104804 E-mail: akgupta@riico.co.in, dpahadia@riico.co.in, riico@riico.co.in Website: www.riico.com/biotech.html Golden Jubilee Biotech Park for Women Society, Kanchipuram This Biotech Park was set up with the aim of allowing professionally qualified women to take up a career of remunerative self-employment, through the organization of environment-friendly biotechnological enterprises. The Park has a Technical Resource Center (TRC) to assist in the field of quality testing, technology development and training. Contact Tel: +91-44-32900973, 32906313 E-mail: biotechpark@vsnl.net, Website: www.biopark.com Gujarat Akruti Biotech Park, Vadodara The Government of Gujarat is developing a biotechnology park at Savli in Vadodara in three phases, in an area of over 700-acre. The park is being developed under public-private partnership. The park has two components - an Innovation Arcade, which is to be developed by a private developer and an Industry Arcade, which is being developed by the state government. Contact Head: Ajay M  Pawar, project director Tel.: +91-22-67037400, Fax: +91-22-28218230 E-mail: biotech@akruticity.com, Website: www.akrutibiotech.com ]]> <![CDATA[Biotech Clusters of India]]> https://biospectrumindia.com/news/95/5737/biotech-clusters-of-india.html https://biospectrumindia.com/news/95/5737/biotech-clusters-of-india.html Tue, 09 Jun 2009 11:34:00 +0530 Biotech Clusters of India Maharashtra continues to dominate Though the biotech industry is well spread across the country, the western and southern regions of the country continued to account for 85 percent of the total revenues generated by companies headquartered in these clusters. Each of these two regions generated in excess of $1 billion in revenues in 2008-09. Out of the two regions, the West with revenues of Rs 5,260.84 crore was ahead of the southern cluster with 43.35 percent share. While the west region’s contribution was led by Serum Institute of India, Biocon and Panacea lead the revenue contributions from the south and the north, respectively. ]]> <![CDATA[Home Grown Companies]]> https://biospectrumindia.com/news/95/2168/home-grown-companies.html https://biospectrumindia.com/news/95/2168/home-grown-companies.html Tue, 09 Jun 2009 11:24:00 +0530 ]]> <![CDATA[The Top 20 BT Majors]]> https://biospectrumindia.com/news/95/2117/the-top-20-bt-majors.html https://biospectrumindia.com/news/95/2117/the-top-20-bt-majors.html Tue, 09 Jun 2009 11:11:00 +0530 The Top 20 BT Majors Overview of the Top 20 biotech companies   ]]> <![CDATA[Growth slows]]> https://biospectrumindia.com/news/95/2503/growth-slows.html https://biospectrumindia.com/news/95/2503/growth-slows.html Tue, 09 Jun 2009 10:30:00 +0530 GROWTH SLOWS Industry grows 18% to Rs 12,137 crore Flat growth in terms of dollars  The Indian biotech industry in 2008-09 registered 18 percent growth, with record revenues of Rs 12,137 crore. However, in terms of dollar business, the industry was where it had been in the last fiscal, i.e., at $2.5 billion, with the price of a dollar hovering around Rs 47 during the year. The exchange rate of the dollar, which was around Rs 40  per dollar in 2007-08, grew by 18-19 percent during the year and this is reflected in the performance of the industry. In rupee terms, the industry registered 18 percent growth. The very nature of the biotech industry, that it is export-driven, is clearly reflected in these numbers. The rise in dollar value helped companies to up their topline. In rupee terms, the exports  business went up by almost 25 percent to Rs 7,152 crore, accounting for 60 percent of the total business in 2008-09, yet the total industry exports registered only 6 percent growth in dollar terms over 2007-08 to $1.5 billion. The domestic business at Rs 4,985 crore ($1 billion), registered 10 percent growth in rupee terms. But in dollar terms, it meant a negative growth of about 7 percent compared to $1.14 billion in 2007-08. The Indian biotech sector is consolidating and looking at various business models to sustain the momentum of growth that it had been recording before 2007 and this is going to be spurned by the industry’s moves to adapt to the next level of change. A clear trend in this direction is the globalization strategy. The activities related to localization of global companies and globalization of Indian companies continued in 2008-09 too. We saw several partnerships being inked. Almost all the major players have entered into several partnerships during the year. The biopharma segment continued to account for the largest share of the biotech industry revenues. In 2008-09, the biopharma sector had a 65 percent share of the total pie with revenues of $1.67 billion (Rs 7,883 crore). In fact, in dollar terms, it’s a negative growth of 2.75 percent compared to the revenues of $1.72 billion (Rs 6,899 crore) in 2007-08. In 2007-08, the segment had accounted for 67 percent share of the total industry revenues, registering 16 percent growth.  The share of exports in the total biopharma pie was close to 58 percent. Exports from biopharma alone accounted for over 68 percent of the total industry, while the bioservices sector had 28 percent share in exports (Rs 1,964 crore). The bioservices sector registered 31 percent growth. The bioagri sector grew by 24 percent to Rs 1,494 crore, the bioindustrial sector by 16 percent to Rs 478 crore, and the bioinformatics sector by 15 percent to amass Rs 220 crore in revenues. Clearly the industry had to handle the challenge of market-to-market conditions. The recessionary effect  in terms of venture capital and private equity funding did not have a dramatic effect on the companies, as the VC firms were anyways not taking the risk of investing in biotech ventures in the country. The global trend that dominated the industry dynamics in 2008 was bigger biotech companies getting acquired, while the small and medium companies signing partnership deals. Though Indian companies were impacted with credit squeeze, the good news is that public funding is on the rise. Now India through the Public Funded R&D bill is encouraging researchers and the academic institutions to  innovate and plans to incentivize the efforts. The generics business is now here to stay and with Obama coming in the biosimilars will have a stronger proposition  than generics because they are difficult and complex to emulate . The entire  pharma generic space is expected to see price erosion up to 90 percent. This erosion in biosimilars  is expected to be 50-60 percent. Looking at the future, India will go the innovation way. The government funding in terms of providing finance, getting into PPPs, their commitment in developing this sector is encouraging and it is prepared to be a financier and steer regulations. Globalization in biotech is largely India-centric. In the future, India will be a part of the global market and will be a part of the pie across the value chain. There will be a lot of marketing alliances where companies abroad can come and Indian companies will play the role of  contract sales organizations (CSOs). Lastly on the globalization front, it will not just be about business opportunities but capability development  that will expose India to actively learn the expertise of the partner.  South Korea is a  best example of this. The alliances prepares companies to go to the next level.  Indian biotech industry in 2008-09 registered 18 percent growth, with record revenues of  12,137 crore. BioPharma sector grows to Rs 7,883 crore. Bioservices sector registered 31 percent growth. Bioagri sector grew by 24 percent to Rs 1,494 crore. Bioindustrial sector grew by 16 percent to Rs 478 crore. Bioinformatics sector grew by 15 percent to Rs 220 crore. SURVEY & RANKING METHODOLOGY     BioSpectrum conducted this survey in association with the Association of Biotechnology Led Enterprises (ABLE). BioSpectrum and ABLE have jointly been doing this exercise since 2003. A detailed questionnaire (survey form) is sent to over 150 companies to capture the needed information for the analysis. This was done during May-June 2009. Companies shared information with us to the extent it was possible by them about their companies and the industry.     The revenues considered for the analysis are biotech products sales and service figures. In several cases, where revenue figures were not available estimates were arrived talking to industry experts.     This year in the list of Top 20 Biotech companies, diagnostics and clinical trials companies have not been taken into account. But the drug discovery services companies have been listed.     Biotech suppliers’ revenues are not considered as part of the biotech definition.     BioPharma included products made by fermentation/animal cell culture (not animal extracts) and plant cell culture (not plant extracts).     The BioAgri segment analysis has included only the GM seeds and molecular markers and related products. So the hybrid seeds business is not a part of the agribusiness sales values.     For all the ranking purposes, we have taken the biotech business only into consideration. Wherever TURNOVER is mentioned it means, sales turnover from biotech. Therefore, turnover wherever mentioned is not necessarily the total sales turnover of the company ]]> <![CDATA[Swine flu and biosimilars]]> https://biospectrumindia.com/news/95/2728/swine-flu-and-biosimilars.html https://biospectrumindia.com/news/95/2728/swine-flu-and-biosimilars.html Wed, 06 May 2009 15:43:00 +0530 Swine flu and biosimilars After a gap of few years, yet another virus scare has threatened to engulf the world. The latest outbreak has been caused by the H1N1 virus, a relatively new strain of the influenza virus. It belongs to the same family of H1N5 virus, or the bird flu and the SARS virus that wreaked havoc in some parts of the world in the last five years.  Of course, the world is better prepared this time to handle the crisis. The global attention is also more because the H1N1 virus has infected people in the US, Canada, Germany which are some of the world’s most affluent countries. The origin of the outbreak has been traced to Mexico where nearly 200 people have died. Because of the high profile of the countries affected, the World Health Organization (WHO) has drummed up a high pitched campaign and governments around the world have launched surveillance and preventive measures. The SARS and bird flu outbreaks were also touted to engulf the world. But they were contained quickly even though the most affected countries were China and her Asian neighbors. The lessons learnt from these two earlier outbreaks will come in handy to contain the swine flu which has been renamed by WHO as H1N1 influenza, to prevent any damage to the powerful pork industry in the US. Leading governments have cranked up the production of only known cure against the virus, Oseltamivir, known by its popular brand name, Tamiflu. More importantly, the innovator of Tamiflu, Roche had licensed Hetero Drugs in Hyderabad, India and few other companies in Africa to boost production capacity and increase stockpiles with health care agencies around the world. Generics companies like India’s Ranbaxy and Cipla too have their own versions of Tamiflu and have offered to produce large quantities of the drug to meet any global emergency. Clearly, the frequent global scares created by the influenza virus has helped to soften the opposition to generics drug manufacturers. In fact, these periodic episodes have brought more respectability to generics drug makers as any distressed society will  be appreciative of the cure providers even if they are generics drug makers. May be the time is right for the entry of biosimilar drugs in the world’s largest market, the US, which had  resisted it so far. The world’s largest biopharmaceuticals market is being slowly prised open for the entry of generic versions of expensive biotechnology drugs. Europe set the tone few years back by granting regulatory approval to a biosimilar version of somatropin, Omnitope in 2006. Now the push has come from President Barack Obama’s campaign promise to open the US market too gradually for biosimilars. A legislative attempt to allow the US regulator, FDA, to permit biosimilars fell through during the Bush administration in 2008. With President Obama as a passionate supporter, votaries of biosimilar drugs have unleashed an array of legislative proposals in March to give push for the efforts to lower prices of biotech drugs. The most notable effort has come from Senators Orrin Hatch and Charles Schumer, representing both spectra of political opinion, who have pitched for providing discretionary powers to FDA to allow follow on biologicals of patented biotech drugs. In fact, their proposal which will be a companion legislation to the path-breaking Drug Price Competition and Patent Term Restoration Act of 1984 or popularly called the Hatch-Waxman Act, seeks an encore. They have proposed reduction in patent exclusivity period from 14 to 5 years. America’s top biotech companies are strongly opposed to the new legislative proposals. For the 1984 Act, allowed the emergence of a strong generics pharma industry in countries like India, China and even in Europe to challenge the might of the Big Pharma. Biotech majors fear a similar repeat act  by Asia’s biotech companies. With President Obama’s support, most experts expect the legislation to sail through and biosimilars would become a reality in the US market by end of 2010. Asia’s biogenerics players have been preparing for this global opportunity. Now they are on the threshold of seeing the long term plans to get a slice of the US market become a reality. However, it will not be cake walk. Asia’s biotech companies will have to invest heavily in improving quality and increasing manufacturing capacities. They will also have to build their marketing muscle in the US to make an impact in the shortest possible time. All these steps will require enormous resources and so the companies will have to gear for the new opportunity in the next two years. <sureshn@cybermedia.co.in> ]]> <![CDATA[Vitamins A and D kits from SciMed]]> https://biospectrumindia.com/news/95/2473/vitamins-a-and-d-kits-from-scimed.html https://biospectrumindia.com/news/95/2473/vitamins-a-and-d-kits-from-scimed.html Wed, 06 May 2009 14:43:00 +0530 Vitamins A and D kits from SciMed —Rajan Gupta, founder and president, SciMed SciMed Technologies, based in Edmonton, Canada, has developed diagnostic kits to determine vitamins A and D contents in liquid milk and infant formula. The company has launched VitaKit A and VitaKit D into the milk market place. Some dairy  processors and diagnostic labs are currently testing and validating these kits in pilot projects. Not all the milk available through various sources of supply contains the ideal amounts of vitamins A and D.  A study done in the past at Cornell University indicated that almost half the milk on supermarket shelves was either under or over fortified. This has clearly created the need for frequent testing and that is the market need that SciMed is hoping to fulfill through VitaKits A and D. Rajan Gupta, the founder and president of SciMed, believes that there is a huge potential for their kits in the Indian market.  They are looking for distribution arrangements in India and it is understood that some of these discussion are at an advanced stage. “The kits use two novel technologies developed by SciMed. The first is a rapid extraction procedure for fat soluble vitamins like A and D and the second is the two proprietary monoclonal antibodies against vitamins A and D,” said Gupta. The rapid extraction process to separate vitamins A and D from milk is the value proposition that VitaKit offers. While HPLC technologies could take two days and more reagents, SciMed’s kits reduce the vitamin extraction step to less than an hour while using substantially less solvents needed for HPLC.  The company sources indicate that the VitaKit assay method is more accurate when compared to HPLC. A lab technician using a single VitaKit can analyze up to 41 samples at a time in less than two hours whereas the HPLC method would take longer time. Future plan of SciMed is to move from liquid milk and infant formula markets to the clinical diagnostic markets. Gupta indicated that they are developing a low cost lab-on-a-chip (LoC) for Vitamin D3 or cholecalciferol, which is  estimated to be a multi-billion dollar market. “A LoC diagnostic kit can be used to detect vitamin D3 deficiencies to prevent 17 varieties of cancer, heart diseases, stroke diabetes etc. Our vitamin D3 biosensor could be used to self diagnose vitamin D3 deficiencies at homes, schools and  medical clinics,” added Gupta. SciMed’s lab-on-a-chip technology platform called SciLOC is based on proprietary nutri-chips. These are disposable microfluidic chips that can perform sample handling, separation and detection from low sample volumes. These chips are inserted into a florescence detection meter that provides a digital readout and can also wirelessly transfer data to a computer for further analysis. Talking about future plans, Gupta said, “Our focus is to develop LoC diagnostic tools that are portable and can produce results almost instantaneously at the point-of-need. The global point-of-need market is estimated at over Rs 59,688 crore last year.” From the liquid milk and infant formula diagnostic market to the larger clinical diagnostic market is the way forward for SciMed. Success would depend not only on product releases but in effectively tapping large markets like India. E Abraham Mathew in Edmonton, Canada ]]> <![CDATA[â€œWe want to be a strategic partner for our customersâ€?]]> https://biospectrumindia.com/news/95/1967/we-want-to-be-a-strategic-partner-for-our-customers.html https://biospectrumindia.com/news/95/1967/we-want-to-be-a-strategic-partner-for-our-customers.html Wed, 06 May 2009 14:41:00 +0530 “We want to be a strategic partner for our customers” —Sudhir Kant, president, Millipore India —MS Mahadevan, vice president, Bioprocess, Millipore India The world’s first integrated validation and process development services lab, popularly known as the Access Lab in Millipore India is shortly completing five years of stellar service for pharma and biotech manufacturers in India. During these five years, the scientists and technologists in this lab have made a measurable difference to the quality of consultancy available to the biopharma industry and has helped manufacturers speed up their market entry initiatives. In an exclusive interview with BioSpectrum Sudhir Kant (SK), president, Millipore India and MS Mahadevan (MSM), vice president, Bioprocess, Millipore India, share more insights.   When was the Access Services Lab opened in India? SK: It was inaugurated by our worldwide chairperson in December 2003. It was approved in July 2004. What was the thinking behind opening the Access Services Lab in India? SK: Millipore always places the interests of customers before anything else. Before our Access Lab came into being, Indian biopharma manufacturers had to go to labs in the US and Europe for their validation and process development needs. This causes months of delay at a time when ‘speed to market’ was critical for their success. The cost incurred was also high due to more expensive services abroad. In addition customers faced tremendous difficulties in coordinating and communicating with the labs abroad. Millipore understood this pain point being faced by its customers and responded with the world’s first integrated validation and PDS lab in Bangalore. MSM: The result is that projects that used to take 6-9 months to complete in labs abroad are now being done in Bangalore where our labs deliver in 45 days to three months depending on the scope of the study/project. What have been the achievements of the Access Services Lab over the last five years? SK: Our Access Lab is the first one to deliver validation services for pharmaceutical and biotechnology manufacturers and start a filter validation lab in India. Through this lab we have worked with more than 30 top biopharmaceutical companies for filter validation and process development services. We have developed downstream processes for more than 10 biotech products and have trained more than 700 pharma and biotech customers through ‘Back to School’ training and paid certification programs. What are the services offered by the Access Services Lab in India? MSM: Millipore has always been at the forefront of validation support, process development and QA/QC. Millipore makes a measurable difference with a full range of services spanning validation, process development, process optimization, project management, microbiology, training and consultancy. The studies conducted at Millipore include extractable, bacterial retention, product integrity, filter compatibility and preservative binding tests. In addition we develop and optimize processes, we are good at aseptic processing and in developing/optimizing processes for difficult to manufacture biologics – particularly recombinant proteins and monoclonal antibodies. In fact worldwide seven out of every 10 units of MAbs manufactured involves partnering with Millipore. Where else does Millipore Corporation have comparable labs? SK: Other than India we have labs in Billerica (US), Molsheim (France) and Yonezawa (Japan). There is no difference in terms of the quality of infrastructure and expertise. We are more tuned to the specific needs of Indian customers, the regulatory requirements of advanced highly regulated markets (US and Europe) are being addressed by Indian manufacturers. We offer regulatory support and validation services for both biologics and pharmaceutical customers. MSM: In addition to similar infrastructure, we have access to the same database. This is critical for being sure about our data and results. Our technologists are in regular touch with each other. Many of the trainings are common with either faculty from abroad coming over or our people being trained in the US and Europe. Work methods and protocols are the same. Plus we benefit from the presence of Millipore experts who consult constantly with regulators. What has been the growth of the Access Services Lab in India? SK: As a practice we do not share numbers. But we have been on target each year for the last five years. The return on our initial investment was recovered in the first nine months and our Compound Annual Growth Rate (CAGR) has been impressive. Almost all the top 30 Indian manufacturers have consulted with us and what is gratifying is that a high percentage keep coming back to us with more projects. In which areas have you offered your solutions and services through the Access Lab? MSM: Oncology, opthalmics, recombinant proteins, monoclonal antibodies, anti-diabetics and sterile active pharmaceutical ingredients (APIs) are some of the most popular therapeutic areas. There are of course many other niche areas in addition.   What are the areas that you feel will emerge in future? SK: Flexible bioprocessing solutions, mycoplasma, rapid microbiology are the new areas. We are also looking at an incubation center. In a couple of months we will organize an advanced training program to teach our customers to manage people and processes together. Disposables will become very popular in the coming years. The pace of acceptance is going to grow fast.  What is the profile of your technology group? SK: Millipore has more than 80 years of combined industry experience. We have a dedicated team of experts who are either PhD holders or have a master degree in microbiology, biochemistry, pharmacology or chemical engineering. Millipore has always concentrated on education. We have regularly been conducting training programs. In partnership with Eppendorf and Metrohm we have also launched a mobile lab, we have installed several equipments in it along with the literature. The lab moves from college to college and educate students by giving them demonstrations. Ch Srinivas Rao and Jahanara Parveen ]]> <![CDATA[Public Funded R&D Bill, 2007, a legal perspective]]> https://biospectrumindia.com/news/95/2585/public-funded-rd-bill-2007-a-legal-perspective.html https://biospectrumindia.com/news/95/2585/public-funded-rd-bill-2007-a-legal-perspective.html Wed, 06 May 2009 14:13:00 +0530 Public Funded R&D Bill, 2007, a legal perspective India’s biotechnology industry has entered into a critical phase. Though biotech has been around for some time now, the industry took shape in the late 1990’s when dozens of academicians turned entrepreneurs. This is almost similar to the situation in the US, when a remarkable piece of legislation, called Bayh-Dole Act opened the floodgates of research centers and led to the emergence of the biotechnology industry as we know today. It was indeed rightly timed, the Indian Government came out with the bill to encourage the scientific community in India whose rights is otherwise not recognized. The US was the pioneer in this regard by enacting the Bayh-Dole Act, 1980, that sought to empower universities for protecting their intellectual property rights (IPRs). Many in the industry too feel the time is conducive since we already have venture capitals in technology development and once the bill is passed and takes the form of an act, it will generate infrastructure as well. At present, the universities and research institutions in India that manage to get government funding lack the mandate to commercialize their research results, which is largely done by the industry. Innovations also get wasted as they belong to the funding agency. The proposed legislation is expected to provide a legal framework to the research institutions that would develop an active interface between the funding agencies, academia and the industry, which has been lacking so far. Scientists are not expected to have profits on their mind when they involve themselves in laboratory work. This is set to change, with the Public Funded R&D (Protection, Utilization and Regulation of Intellectual Property) Bill, 2007, drafted by the Central Government and apparently being circulated among the ministries. The bill is expected to commercialize research from public-funded institutions as they have been largely insulated from the challenges of the competitive environment in which private-funded research operates. Companies typically get their research patented, following which they try to leverage the research into a viable commercial product. The bill seeks to encourage public sector research organizations to patent their inventions and offer them to the industry for commercialization on a revenue-sharing basis quite like how the Bayh-Dole Act did for American universities. The bill will provide the enabling mechanism to permit research institutes to own IP on publicly-funded research projects. Government funded R&D bodies like CSIR among others are set to be covered under the proposed law. The legislation should be a broad guiding framework and specifics should be left to the rules that are made later taking into account in the changing environment. Questions for consideration Will the legislation bring institutions and corporations too close to each other for public comfort? Is there a way to get the best research on board and not just that of a high profile researcher or scientist? And, most importantly, what happens to national interest, in terms of pricing and access to a medicine developed through public-funded research and subsequent commercialization? It would be useful to incorporate penalty provisions in the proposed bill if not included which may act as a deterrent for scientists from infringing their rights to reap profits out of their inventions. Scientists need to put their protected work in the public domain. Various agreements will take place between the public and private sectors and the technology that bears fruit from the research should be evaluated properly with the appropriate commercial yardstick. Some of the major features of the Bayh-Dole Act, 1980 (BDA) are, non-profits, including universities, and small businesses may elect to retain title to innovations developed under federally-funded research programs; universities are encouraged to collaborate with commercial concerns to promote the utilization of inventions arising from federal funding; universities are expected to file patents on inventions they elect to own and universities are expected to give licensing preference to small businesses. The BDA was part of the attempts of the US Congress during the 1980s to create a unified government patent policy pertaining to inventions made with federal support, to promote invention-related activities among the academia. The bill has triggered another global debate on the impact of IPRs on development and access to public health that have occupied the centre-stage in the last decade, starting with the Doha Declaration. The introduction of the IP bill now in India perhaps also typifies the confused mindset of most developing countries whether to adopt or adapt the western models of IP protection regimes for development given the complexity of the issues.  Supporters of the IP bill, largely the government functionaries and some section of the Indian industry, chant the IP mantra – innovate, patent and prosper. At the other end are the academics, civil society groups both from India and abroad – voicing serious concern on both the bill itself and the way it is being rushed through the Indian Parliament. There are numerous opportunities in the biotechnology sector in India. With enough scientific manpower, India has the vital ingredients for success in biotech and pharmaceutical R&D. However in order to harness this talent, care must be taken to address the above issues in an enabling business environment with a pragmatic, entrepreneurial mindset. The Public funded R&D bill in India should be debated far and wide in order to make it a realistic and effective piece of legislation. Kirit S Javali, partner, Jafa & Javali, a full-fledged corporate law firm with niche expertise in IPR and Biotech law, with offices in New Delhi, Bangalore and Mumbai. ]]> <![CDATA[Public funded R&D bill]]> https://biospectrumindia.com/news/95/2448/public-funded-rd-bill.html https://biospectrumindia.com/news/95/2448/public-funded-rd-bill.html Wed, 06 May 2009 14:10:00 +0530 Public funded R&D bill The scientific community is hopeful about the Public funded R&D bill, modeled on the popular Bayh Dole Act enacted in the US, although a few apprehensions are still abound. We find out more about the scope of the bill. The Bayh Dole Act introduced in the US in 1980 created a uniform patent policy for the universities to own rights to patent resulting from federal funded research and to license these patents on an exclusive or non-exclusive basis. The underlying objective of this act was to stimulate innovation and ensure commercialization of the technology leading to increased public access to federally funded research. Taking inspiration from the Bayh Dole Act, the Protection and Utilization of Public Funded Intellectual Property Bill 2007, was introduced in the Rajya Sabha last year by the Science and Technology Minister, Kapil Sibal to develop a framework for protection and utilization of intellectual property created out of public funded research and development. The bill seeks to provide a funding agreement between the government and the recipient before release of grants for R&D and also seeks to bar public disclosure, publication and exhibition of the public funded intellectual property. The bill is expected to ensure access to innovation by all stakeholders for public good and also enhance awareness on intellectual property issues, especially in universities, academic and research institutions. If the bill is enacted the scientific community will get several benefits out of it. BioSpectrum finds out the apprehensions and hopes of the scientific community regarding the bill that might see the light of the day soon. Dr PN Rangarajan, professor, Department of Biochemistry, Indian Institute of Science, Bangalore,  opined, “The Public funded R&D bill will certainly clear the confusion that is currently there on Intellectual Property Rights (IPR) arising out of publicly funded research. Almost 95 percent of R&D in Indian institutions is funded by government sources and many a times the funding agencies insist that the investigators sign an agreement to ensure that the IPR arising out of the research belongs to the funding agency. The bill with give a fillip to R&D and innovation by allowing the investigator and research institution to own the IPR and negotiate with an industry partner of their choice. A lot more innovations are likely to flow into the market place and in the long run it will definitely contribute to a better economic growth of the country.” The bill also includes a public private partnership model which many feel has its distinct advantages. While commenting on this Dr Rama Mukherjee, managing director, Ara Healthcare, Gurgaon, said, “ Public funded R&D feeds industrial R&D, the academic information leads come from there, so a greater synergy between academia and industry would be great.” She also hopes that the bill will re-energize Indian Council of Medical Research (ICMR), Department of Biotechnology (DBT) and Council of Scientific and Industrial Research (CSIR) institutions leading to a better level of science and scientists in the country. Echoing the same sentiment, Murali Nair, partner, advisory services, Ernst and Young, Mumbai, had earlier said in an interview to BioSpectrum that a commercial relationship between industry and academia will result from the implementation of the bill. “People will be engaged in a meaningful commercial research while they are still in campus and it will facilitate a number of research projects because the infrastructure gap can be narrowed and balanced,” he had said. However, there are certain apprehensions surrounding the bill as well. Dr Souvik Maiti, senior scientist, Institute of Genomics and Integrative Biology, Delhi, stated, “If the bill takes away the rights of the inventor or scientist to decide on whether the invention should be patented or should remain in the public domain, it will be a grave mistake. Unlike the American situation in the 1980s, in India there are several gaps that lead to the limited commercialization of scientific knowledge. This legislation alone cannot address all these gaps and therefore, may not provide a great impetus for innovation.”   Dr Sachin Chaturvedi, a Fellow at the Research and Information System for the Developing Countries, New Delhi, said that biotech is entering into a different patent regime owing to the growing convergence of technology. Hence a national regime on patents may not serve the purpose as good as the National Biotechnology Regulatory Authority (NBRA), which would be far more competent to deal with patents in the biotech sector. He further said that the bill is going to add a huge value to the effort of scientific institutions by enabling them to realign themselves with market oriented research. It will also create a greater synergy between the public and the private sector.  ]]> <![CDATA[Beckoning Indo-Canadian partnerships]]> https://biospectrumindia.com/news/95/2638/beckoning-indo-canadian-partnerships.html https://biospectrumindia.com/news/95/2638/beckoning-indo-canadian-partnerships.html Wed, 06 May 2009 14:06:00 +0530 Beckoning Indo-Canadian partnerships Dr Nataraj Kav, professor of biochemistry, Department of Agricultural, Food and Nutritional Science, University of Alberta, Canada, outlines the relationship between India and Canada, and its future prospects. Canadian and Indian Governments have recognized the need for a closer collaboration between the two countries and the signing of a Memorandum of Understanding (MOU) between the University of Alberta, Edmonton, Canada, and the Indian Institute of Technology (IIT), Mumbai, is yet another example of institutions in both Canada and India forging ahead on collaborative ventures. Other recently signed agreements include the one between the National Research Council (NRC) of Canada and the Department of Biotechnology (DBT), India; and between the Agriculture and Agri-Food Canada (AAFC) and The Energy Research Institute (TERI).  An area of obvious choice for collaboration between India and Canada would be in the field of agricultural biotechnology. It is needless to point out that India faces significant challenges in ensuring that its population has access to sufficient food of high quality with minimal adverse effects on the environment. Canada and India (as well as all other countries of the world) are faced with changing global climate, which of course, has significant effects on crop productivity.  Many of the crop varieties that are cultivated today have reached an yield plateau, necessitating the development of novel varieties capable of maintaining increased levels of productivity despite increased environmental stresses and changing disease patterns. India and Canada have sufficient and highly complementary core strengths in the areas that are related to the development of novel crop varieties. In fact agricultural biotechnology and food science and technology should join hands to develop novel crops with beneficial health properties and find ways to deliver them as pre-packaged convenience foods. For example, compounds with beneficial health properties can be identified from Indian plants through this collaboration, Canadian and Indian scientists can elucidate their modes of action using the state-of-the-art techniques in genomics and proteomics.  Subsequently, metabolic pathways producing such compounds can be characterized and engineered into the crops of interest, resulting in “functional foods” or, alternatively, provided in the form of nutraceuticals. There are already a few areas of collaborations between Canada and India, and there is more scope to grow such collaborations. The interest of researchers in both the countries has to be stimulated to materialize such partnerships. In fact, International Science and Technology Partnerships (ISTP) Canada, a non-governmental organization selected by the Government of Canada, encourages partnerships and collaborations such as the above. In India, Global Innovation and Technology Alliance (GITA) has been entrusted with the task of fostering linkages under the auspices of the Department of Biotechnology as well as the Department of Science and Technology, Government of India.  In addition, the Shastri Indo-Canadian Institute is another agency that supports partnerships and collaboration between India and Canada.  It is up to individual researchers to identify areas of cooperation, pursue collaborative research that supports the training of Highly Qualified Personnel (HQP) such as graduate students and post-doctoral fellows to jointly overcome the challenges of this and forthcoming centuries, one at a time.  HQP are our investments for the future and, therefore, it is important for both the Canadian and the Indian Governments to commit to the establishment of an Indo-Canadian scholarship program to allow the exchange of the brightest minds without hindrance. Students ahoy An important aspect of any collaboration between the Indian and Canadian institutions will, undoubtedly, be an exchange of graduates or post-graduate students, post-doctoral fellows (PDFs) and faculty members. Canada has several universities that have successfully developed food science and technology programs, including a program at the University of Alberta that is in high demand. The post secondary education and research environment in Canada is top of the line and comparable to excellent institutions worldwide. The training, a graduate student receives from research-intensive universities such as the University of Alberta, is of high caliber, many PhD holders from Canadian institutions obtain research or other positions in prestigious institutions in various parts of the world. In addition to top-class universities, Federal and Provincial governments are also conducting world-class research in various fields and, very often, researchers from the universities and these government research institutes enter into collaborative ventures and offer graduate students with unique opportunities pertaining to the application of their research findings. Canadian scientists can therefore provide invaluable guidance towards the development of strategic research in areas pertaining to food science and technology.  Furthermore, they can provide guidance with respect to the development of curriculum for successful undergraduate and graduate programs.  Dr Nataraj Kav is a Professor of Biochemistry in the Department of Agricultural, Food and Nutritional Science (AFNS) at the University of Alberta, Edmonton, Canada. Dr Kav has launched a successful proteomics-based research program at the University of Alberta to investigate plant responses to both abiotic and biotic stresses.  The proteins and, consequently, genes are manipulated using transgenic technology in order to improve plant performance under stress conditions. Dr Kav’s research team is composed of graduate (MSc and PhD) students, post-doctoral fellows and research associates, some of whom are from India and/or the Indian sub-continent. ]]> <![CDATA[Patents choke innovation in India]]> https://biospectrumindia.com/news/95/6639/patents-choke-innovation-in-india.html https://biospectrumindia.com/news/95/6639/patents-choke-innovation-in-india.html Wed, 06 May 2009 14:02:00 +0530 Patents choke innovation in India -DG Tripathi, president, ADMI and director, Tulip Group of Companies In India, the in-vitro diagnostic (IVD) industry is considered as a part of the biotech sector and is often referred to as the ‘sunrise sector’. IVD, being a relatively nascent yet fast growing industry, is adversely affected by the intellectual property issues, especially after the amendments to the Indian Patents Act of 1970 in 2005, which was effected to make the Indian Patent Act Trade Related Intellectual Property Rights (TRIPS) compliant. It is well known that the objective of patenting system is to foster innovation and technology in order to bring new inventions to the market for the benefit of the society, with the innovator being granted a monopoly for a limited time-period to commercialize and practice the invention through its industrial applicability. However, if rogue corporations, lawyers and individuals hijack the patent system by filing frivolous patents, the core objective of patenting is affected. Instead of encouraging R&D and nurturing science the filing and granting of these frivolous patents persecute competition and thwart the industry growth. And that is what is happening in India. Some IVD companies in India have been systematically filing frivolous patents. The most unfortunate part is that these patents are being granted, and that too on a fast track by the Indian Patent Office, in many instances against what is provided for by law. Most of these patents are blatant copies of existing patents, or mere rehash of what is available in the public domain since decades. Till date most specifications that have been published, fail the basic tenets of patentability i.e., inventiveness, obviousness and anticipation. It is absolutely beyond comprehension as to how such blatantly frivolous and bad applications are allowed to escape the search and scrutiny process. While it is true that the number of patents filed by inventors is a barometer of any country’s technological progress and prowess; on the flip side the number of frivolous patents that are granted in a country is a barometer of the ethical standards, the inventors themselves uphold, and the competence and independence of the examining process itself.   The pre and post grant opposition process has to be objective and ethical and has to play by the set rules. If unscrupulous companies are favored and the patent office insists on granting such patents at amazing speed it only serves to undercut the industries’ future and incurs a grave cost to the customers and society at large. In India, typically while the cost of filing a patent is about $6000-$8000 (Rs 3-4 lakh) per patent, if a patent attorney is engaged; the cost of fighting an infringement and revocation petition in high court is pegged anywhere between $100,000 and $200,000 (Rs 50-100 lakh) per patent. And the average time to settle an infringement suit could be anywhere between five-10 years, provided the legal process works without time delays. Fully aware of this, unscrupulous individuals, corporations and patent agents have spawned a multi-crore litigation industry that frustrates and punishes ethics and rewards brazenness. This group serves the interest of individuals and companies that plan to use litigation to thwart competition and deflect the attention of the industry from the productive engagement in running technology intense business to running from pillar to post, in order to find justice. The Association of Diagnostic Manufacturers of India (ADMI), in March 2007 and subsequently in December 2008 has already represented to the Ministry of Commerce and Industry and to the Controller General of Patents in this regard, with copies to all stakeholders. Unfortunately, these representations seem to have fallen on deaf ears. While the industry and the ADMI, contemplates future course of action and want to stress that the patenting process in India must: Ensure that patents are granted to only those applications that qualify for the same. Eliminate and discourage false, fraudulent, frivolous, excessive and repetitive claims. Provide an effective, quick and economical method for revocation of frivolous patents. Provide a mechanism for punishing companies/individuals that habitually file frivolous patents. It may be pertinent to add that since grant of patents to a patentee is without presumption of its validity, in case of an infringement petition no action should be taken by the courts until the validity of the patent is established in the counter revocation petition. Biotechnology being a relatively new and evolving area, adequate and appropriately qualified examiners are needed to supervise the pre-grant examination process in order to understand the art comprehensively. Just as the IVD industry has woken up to the rude shock of the new patent regime and its unexpected consequences, it is time that the biotech fraternity wakes up to this situation and proactively moves towards a solution to protect the interests of all the stakeholders. After all—forewarned is forearmed.  ]]> <![CDATA[Choose the right business model to beat recession]]> https://biospectrumindia.com/news/95/1957/choose-the-right-business-model-to-beat-recession.html https://biospectrumindia.com/news/95/1957/choose-the-right-business-model-to-beat-recession.html Wed, 06 May 2009 13:40:00 +0530 Choose the right business model to beat recession Economic slowdown certainly makes business management difficult however choosing the right business model can make it easy. The economic slowdown has affected all the business sectors, even the major drug manufacturers like Dr Reddy’s Laboratories, Wockhardt and Biocon have not been spared. The new start-ups and the mid-sized companies felt the greatest sting. The numbers may be small but the trend of small start-ups closing down in the recent past can lead to a much feared catastrophe of stagnation. The reasons for setback could be attributed to lack of focus, lack of marketing skills or lack of cash flow into their venture. The mistakes A lot of start-up biotech companies dig their own grave much before they commence their operations. This coupled with lack of proper focus and planning ultimately leads to their premature death. According to Sandeep Saxena, founder and CEO, Acton Biotech, Pune, “Many biotech companies burn a lot of cash right from the word go. We often see that from the very beginning, these small start-ups make huge investments, employ a lot of people and sales force with a hope that their business will pick up with such heavy investments. Hiring highly skilled sales force from reputed institutes has its benefits but that can be a hitch at times. Due to their high qualifications, these employees demand for higher salaries and perks that can drain out a lot of cash from the company. Moreover despite this many a time the sales force lacks marketing capabilities. Many companies have a sound technological team but fail to put in place a strong marketing and sales team.” Dr Rama Mukherjee, managing director, Ara Healthcare, Gurgaon, said, “Outsourcing of work to India is not going to stop, but it will reduce. Ara Healthcare has been working on a number of molecules because that is the best way to keep a multi-disciplinary scientific team engaged. Companies today are having equity or valuation problem, with share values of some of the best companies dropping. Getting equity at the right value of the company is difficult. The government agencies have been very helpful. We are expecting positive signs from Biotechnology Industry Partnership Program (BIPP), this along with contract research in cloning and expression of recombinant proteins will keep our revenues afloat. Our diagnostic services are our biggest revenue generator. We might be facing an economic downturn right now, I am sure that in another six months time the situation will change.” The available capital to fund biotech companies has all dried up. Many companies are drastically cutting their budgets and freezing investments in order to preserve their capital to focus on their most promising projects that have the shortest path to market. Several other companies kick start without any focus on their business plan and invest their eggs in many baskets. “Biotech companies start with something, then get a better related opportunity and move to that, leaving the first objective incomplete. This is coupled with launching their products without understanding the dynamics of the market. So, it is very important to take inputs from customers in order to have a better understanding of the market,” opined Saxena. The main hurdle for a biotech company is the financial support. Many companies close down mid way because there is no financial backing for their ambitious plans and in India the concept of venture capital (VC) is not popular. With respect to start-ups or early stage biotech companies, there can be several general as well as company-specific reasons for this crisis situation. According to Anand Daga, founder and managing director, Aumgene Biosciences, Surat, some of the significant reasons are: Disparity in commitment levels of the management team and/or company founders, particularly in the early stage of the company when the cost and time involved in product development are overwhelming. To withstand this all the team members must be willing to go not just one but several extra miles. Faulty or poor assessment of risk involved in the venture. Many start-up companies miscalculate the time and resources required for product development, regulatory clearances, and manufacture, market and sell biotech products. So even if the management team is strong and committed they run out of gas to cover the extra miles. Choosing a wrong financial partner. This may be a venture capital or angel investor or any partnering company that does not understand biotech or is not as long term committed as the entrepreneur. The ideal model Experts opine that issues in cash flow occur because the industry is not well versed with the art of saving despite the fact that a biotech venture requires a huge amount of investment than any other industry. “Companies should gear themselves up to have their beginnings from a garage where they can save a lot and use up those savings for buying further material,” observed Saxena. Though many have been concentrating on cost reduction, a few others have been exploring all opportunities and focusing on innovation programs and setting up additional product lines or processes to buffer the business from the slow down. Above all, instead of burning cash at an early stage, companies should have their focus right from the beginning. Getting into niche markets and arena can offer a wider range of opportunities than tapping their investments in many segments at the same time. According to Dr Rajeev Soni, president and COO, Premas Biotech, Gurgaon, “It is pertinent that start-ups focus on a niche area rather than playing in a crowded space. This will help them to maintain healthy margins where most other companies are adjusting by dropping prices. The biotech companies should shift their focus to long term contracts rather than short term projects to take advantage of this scenario. The long term project ensures continuity thereby allowing us to continue recruitment and investment. Premas Biotech has also added a few more competencies to enhance the capabilities of the company.” “Companies have to keep their core projects insulated so that they are not affected. Depreciation of rupee is a major issue that upsets the revenue of the company. Outsourcing has also come down, many companies, mainly contract research organizations, are not getting the projects that they have been anticipating. We need to focus within the company, and a greater cohesion between industry, academia and department is required. Public private partnership is the way out; the module adopted by the Department of Biotechnology (DBT) is exceptional,” stated Dr Rama Mukherjee. However, Dr Soni believes that start-up CROs are in a growth phase and hence have not been impacted by the current recession. “Recessive times bring in more prudence and most enterprises look at optimizing their expenses. In this scenario outsourcing gets a boost as cost cutting becomes essential and not optional. Entrepreneurs should maintain a fine balance between the company’s finances, products, operations and marketing capabilities. Companies should have their marketing concepts and fundamentals in the right place. “It is very much like the case of Apple and Microsoft with despite the former being a high-end Operating System failed to have an outreach in the Indian market, while Microsoft which had the upper edge in its marketing capabilities has a wider reach and still rules the Indian market. It has been noticed that there are biotech companies that have a not so good profile but have excellent marketing capabilities and end up doing well in the market,” added Saxena. “From my experience a biotech company should try to create a cash cow business along with pursuing a mid to long term product development goal. This might seem like an unconventional suggestion because a start-up company having limited resources cannot ride on multiple boats and also by doing so would lose its focus.  Having a cash cow type revenue generating biotech business such as manufacturing or just trading in less regulated and faster marketable products can be a good strategy to mitigate risks in biotech company in an early stage. The biotech companies should also be prepared to cope with both current as well as future recessive periods, when there will be more pressure in controlling costs especially in high risk R&D based product development,” opined Anand Daga. Sameer Savkur, managing director, ORG IMS Research, Mumbai, said, “Recession like this does impact all stakeholders in the value chain that includes patients, manufacturers, distributors and healthcare providers. Growth might be impacted but in the process companies should not exit commercial areas where there are growth opportunities. In terms of approaches, companies need to revise their business strategies, rethink their R&D strategies, look at their product portfolios and make their sales forces more effective.” Recruiting skilled manpower is one of the effective models. Recession provides a great  opportunity to recruit highly talented people who would otherwise be employed. While commenting on this Anuradha Acharya, CEO, Ocumum Biosolutions, Hyderabad, said, “Downturns have always proved good for Ocimum, this is the apt time to get really good talent for very cheap. I cannot really dream of getting those people of those levels during normal times.” While commenting on the recruitment strategy Saxena opined “With the savings available the biotech companies should hire people in a step-by-step process. And for start-ups, it is not necessary to hire people from Indian Institute of Management (IIM), even graduates can be equally capable.” Experts also suggest that more than reducing costs, successful resource efficiency increases the utility of products and services. It can also ensure more cost-effective compliance while promoting competitiveness through product differentiation. The challenging times offer new opportunities for biotech companies to get stronger. This is an apt time to evaluate present business model and look for new openings in the competitive landscape by finding new solutions to fulfill customers need that other firms are not addressing. Jahanara Parveen with inputs from Nayantara Som and Shalini Gupta This as an opportunity to become stronger -Sushil Mehta, MD, RFCL, New Delhi It was a cold and windy evening in the second week of March 2008 at downtown Manhattan, when we walked into a Café to unwind after a day’s hectic business deliberations. RFCL Team was visiting the US to explore its expansion plans. The hustle and bustle at the largest financial capital of the world seemed as usual, only to be proven wrong next morning when the pink papers carried the story on “Bears and Sterns” bankruptcy. We were fortunate to hear early warnings of global recession while sitting in the midst of the global financial capital. This distress signal came to us at the right time when we were finalizing our budgetary plans for the fiscal 2008-09 and the epithet was loud and clear: Our growth plans should not dry up liquidity at the company. Focus on operational efficiency and thereby generate more cash. Engage good people (people in context of future and not past). Accelerate the speed of implementation (most often overlooked or not given priority). The above guidelines became our operational philosophy for the next six months and continues to be so till date. Come October more and more financial investment companies who had risked high on reverse mortgage came with financial results which wiped out the assets created over years and decades. This indeed triggered recession all over the corporate world. Even as management after management looked for ways and means to deliver as per guidance, the worm of recession had slowly crept into the psyche of the corporate world. All over the corporate world cash was pronounced as king and capital expenditure as a forbidden fruit. I observed that sitting around the lunch table at RFCL the discussion would invariably move to global recession. Suddenly some one said let us make a conscious effort not to talk about it and honestly it has helped. May be not in keeping recessionary trend at bay, but it has surely helped in creating a mind set within the organization to search for solutions and most importantly to strive towards learning the balancing act to manage growth and costs. Has it helped? Honestly yes. At RFCL we have registered a growth of 29 percent on organic basis and 48 percent on inorganic basis for the fiscal year just concluded. In fact the present global crisis can be converted into an excellent opportunity for Indian companies and for Indian enterprises as the competing economies will be busy in their cleaning act. The successful companies of the future will be the efficient companies and they will emerge stronger through this downturn period thereby differentiating and polarizing boys from men. It is the right time for brave actions for those who have the skill and willingness to outpace market growth. We certainly are not immune to the events unfolding in global market but a focused leveraging of our strengths will mitigate the effect. India will be much quicker than the West in regaining tempo of growth. We as a country have a history of giving our best in adversity. Furthermore, pharma, biotech and health care as an industry is more immune to this recession and as such the impact felt by the players in the industry would be relatively smaller. For a company like ours which gets almost entire revenue from domestic operations the global slowdown gets marginalized because of a majority play in the domestic market. Interestingly, I would like to add that it is ironical that our exports in the last 12 months have more than doubled, increasing the revenue contributions from two percent a year ago to five percent of sales for just concluded fiscal year. Does it vindicate what we said earlier with respect to developing a positive mindset even in challenging times? A focus on operational efficiencies is the key, especially for mid-sized companies with moderate or no reserves. So it is not only important but pertinent to: Flush out unneeded costs (cost savings through waste elimination and process improvements). Ensure efficient management of inventories (increasing MAT percentage) Ensure that growth is also driving the costs downward. Encourage innovation (balance between efficiency and innovation as innovation will bring returns only in long term). Managing performance (clear cut distinction between strong and mediocre performers) Right sizing the organization. The most vital point for the leadership team is to communicate the need for all of the above to employees and especially of the importance of reducing cost to sales ratio. Organizations must develop well-planned communication strategy. To maintain employee morale and to allay fears, organizations should develop unified, consistent and continuous communication. People are realistic and appreciate truth. Finally, it is important to remain focused in this time of crisis and use this as an opportunity to become stronger and remind ourselves that India is going to be one of the key drivers of global growth and we should feel fortunate to be in this market as long as we can be efficient and nimble. I would say “reach out for stars with feet on the ground.”  ]]> <![CDATA[Wockhardt crisis, an eye opener for biotech sector]]> https://biospectrumindia.com/news/95/1409/wockhardt-crisis-an-eye-opener-for-biotech-sector.html https://biospectrumindia.com/news/95/1409/wockhardt-crisis-an-eye-opener-for-biotech-sector.html Wed, 06 May 2009 13:08:00 +0530 Wockhardt crisis, an eye opener for biotech sector A spree of back to back acquisitions along with indiscriminate raising of FCCBs have cost Wockhardt dearly but this should be an eye opener for biotech companies that are already reeling under financial crunches and going for large scale borrowings. The saga of Wockhardt, India’s sixth largest pharmaceutical giant, is a lesson for biotech companies that are aspiring to follow the track of “aggressive” asset building. Indiscriminate costly borrowings and going in for huge Foreign Currency Convertible Bonds (FCCBs) based on pure speculation, have led Wockhardt to its present crisis with a net debt standing at over Rs 3,000 crore as of December 31, 2008.   Wockhardt announced that it has approached the Corporate Debt Restructuring (CDR) cell to restructure its burgeoning debts and liabilities. Habil Khorakiwala has stepped down as the managing director of the company and he handed over the reins to his son Murtaza Khorakiwala. Habil Khorakiwala retained his position as the chairman of the company. In a press statement to the Bombay Stock Exchange (BSE) dated on March 31, 2009, Wockhardt announced that “In view of the adverse market conditions, liquidity constraints and debt burden the board has decided to make a reference to CDR through ICICI Bank Limited for financial restructuring debts of the company” Wockhardt was due to come out with its audited results in March 2009. However in a statement to the BSE, Wockhardt announced that on account of potential restructuring of businesses of the company and its subsidiaries, which the company is currently evaluating the audits could not be completed.  Not only Wockhardt but few other biotech companies are also affected by the credit crunch. Biotech companies, perpetually reeling under credit crunches and hiccups will be badly hit if the inertia and lack of understanding of market dynamics continues. Without evaluating the consequences, these biotech companies are forced to approach banks and private equity (PE) firms to fund their projects. Industry pundits are of the opinion that the companies are opting for a buyout or selling part of their stakes, because under the burden of debt, biotech companies cannot sustain on their own for a long time. This situation is a classic example of  survival of the fittest. The big fish survives while the smaller fish gets eaten up. Stuck between the devil and the deep sea Much has been spoken about its mounting debt burden, but Wockhardt has been hit by its indiscriminate raising of FCCBs to the tune of Rs 547 crore based on market speculation that investors would inevitability convert them into shares which could have been a good revenue churner for the company. Wockhardt raised FCCBs at a convertible share price of more than Rs 400 which was not agreeable to investors considering the present volatile market dynamics and the dropping share prices of Wockhardt to less than Rs 80.  The company’s forex predicament of last four quarters further added to the net debt burden of Rs 3,400 crore. According to analysts, the company is in such a tight situation that even if it wishes to sell off all its assets it would be difficult to redeem their debts because even its acquired companies have not been doing well, and prospective buyers have put a freeze on investments. The promoters of the company have pledged 43 percent of their total 74 percent stake in the company but analysts predict that even this might not be enough to repay all its debt. An analyst opined that there was a combination of three factors which contributed to Wockhardt’s woes.  Wockhardt raised FCCBs, redemption of which will happen in September 2009 at a 30 percent premium which is Rs 721 crore. Financing its acquisitions happened through external commercial borrowings (ECBs). In addition to this Wockhardt had bought a lot of market instruments to hedge itself against the dollar when it was moving down. Now the dollar is moving in another direction and Wockhardt’s mark-to-market is coming at Rs 300 crore. The global recession and pressure on generic prices in developed markets have compounded the matters. Immediately after the announcement of its adversity, Wockhardt share prices fell by 11.1 percent despite the sensex moving up. Rating agency, Credit Rating Information Services of India Limited (CRISIL), downgraded Wockhardt’s rating under  rating watch with negative implications in the event of shortfalls and delays from the company’s side to repay its loans. CRISIL downgraded its rating on pass through certificates (PTCs) from P4 to P5.  Reports are that SBI has given a funding of Rs 100 crore and  Fortis Healthcare is about to buy Wockhardt’s healthcare division and its 100 percent subsidiary, Wockhardt Hospitals. There have been talks doing the rounds of a deal closing in between the two groups wherein Fortis promoters will get to acquire up to 74 percent stake in the Wockhardt Hospitals. Biotech blues Biotech sales and revenues constitute a minuscule share of Wockhardt’s total revenues, as its core business has always been pharmaceuticals, especially generics. The company earlier had ambitious plans to foray into the biosimilars market and currently sells three biotech products in the Indian market—Biovac-B (hepatitis B vaccine), Wepox (anaemia) and Wosulin (insulin). Moreover industry experts said that Wockhardt’s insulin product, Wosulin, has not been doing well in the market due to quality issues and now the liquidity crisis can make matters worse. “For a product like Wosulin, which is an expensive and high-end product, the company can approach only a high-end doctor who will need a lot of convincing to buy the product. Marketing of such a product requires a huge investment that will not happen when the company is in financial crisis,” commented the same expert. “In addition to this, there are other biotech products which are in the pipeline that includes Glaritus, which was launched recently. Now with its cash tight situation, chances are that the success rate of these products can be very low because we will see a major drop in its investments,” commented an analyst. Wockhardt recently launched Glaritus, a recombinant human insulin that works slowly for over 24 hours. As an expert rightly put it, “The fate of its biotech division depends on just six products. Wockhardt has gone into such deep debt that it has no other choice but to either divest its biotech division or look out for a possible sellout or a strategic partner.” Pfizer and French drug company, Sanofi Aventis, are reportedly doing due diligence to pick up stake in Wockhardt’s biotechnology business. Both these companies have been eyeing the biotech market for a long time. Pfizer has already bought out Wyeth as a first step to enter the biotech arena. According to reports, the value of the deal could be about Rs 250 crore. The deal would be more in the nature of a strategic business tie-up rather than a complete sell out.   Wockhardt established a biotech park in Aurangabad, Maharashtra, in 2004, which has six manufacturing facilities. Wockhardt reportedly claims that the complex has the capacity to cater up to 15 percent of global biopharmaceuticals demand that could be worth Rs 497,300 crore by 2010. Biotech counterparts to follow the same path Despite the biotech industry growing between 15-20 percent, the problem of running into a liquidity crisis haunts every Indian biotech company. Experts are optimistic about the biotech sector in India, but unfortunately the Indian biotech companies are constantly reeling under pressures of funding for their larger-than-life plans which might force them to go into indiscriminate borrowings. While the smaller companies die out, the bigger ones look out for a strategic partner or selling out stakes to a cash-rich company. The lack of financial backing is hindering the expansion of Indian biotech firms and a very few venture capitalists are eager to invest in the biotech sector. Economic slowdown has made things worse for Indian biotech companies. Biotech companies like  Avesthagen have shelved out their plans to go in for an initial public offering (IPO).  Bangalore-based Avesthagen is another company which is reportedly running under debt issues. Dr Villo Morawala-Patell, founder of Avesthagen, told that they have put on hold many projects and they were looking at raising funds from banks (ICICI venture being one of them) and postponed their IPO plans. An internal source from the company revealed that the company is under serious debt and is looking for funds from external agencies. There were reports that many people were laid off but Dr Patell said that these people resigned on their own will. Reports are that the debt arises mainly from the complex business model the company follows. The company wanted to raise around Rs 600 crore from stocks last year but even that was shelved out. Reports are that it will now raise Rs 150 crore through private equity investment. Now, biotech companies need to consider the feasibilities of their ambitious projects, many of them either being shelved or delayed. The government intervention, both at the state and central level, is the need of the hour and this coupled with awareness among venture capital investment firms is also needed. Experts are of the opinion that companies of the size as that of Wockhardt should be judicious as far as their investments are concerned. “Wockhardt went on an indiscriminate acquisition spree without being cautious. But biotech companies need to be very careful especially when it comes to acquisitions, because many a time acquisition might not reap much benefits. It is high time that Indian companies learn to be judicious in their spending especially now in this period of global recession,” advised a renowned auditor. Nayantara Som ]]> <![CDATA[A new era of stem cell research]]> https://biospectrumindia.com/news/95/1403/a-new-era-of-stem-cell-research.html https://biospectrumindia.com/news/95/1403/a-new-era-of-stem-cell-research.html Wed, 06 May 2009 13:05:00 +0530 A new era of stem cell research The DCGI’s clinical trial approval to Stempeutics for stem cell therapy is a milestone for regenerative medicine; the approval potentially opens the door for clinical testing of more stem-cell derived cell therapies. In a move signaling the beginning of a new era of stem cell research, the Drug Controller General of India (DCGI) has given its nod to a proposal on stem cell-based research for human clinical trials in patients with cardiovascular diseases to be conducted by Stempeutics Research, a Bangalore-based stem cell company from the Manipal Education and Medical Group. Stempeutics will conduct study on patients with acute myocardial infarction (AMI) and critical limb ischemia (CLI), the company had applied for the DCGI clearance about 18 months back. According to the company sources, the Government of India had directed the Indian Council for Medical Research (ICMR) to constitute an expert committee on stem cell research and therapy to examine the proposal and the committee that was set up accepted the study as phase-I/II clinical trials. The ICMR and the DCGI have already approved the protocols from the company. BN Manohar, president, Stempeutics Research, Bangalore, said, “We are the first company to get DCGI clearance to start human clinical trial of stem cell-based drug. Based on the results of the clinical studies, Stempeutics plans to introduce the first stem cell-based drug available off-the-shelf in India by the end of 2011.” The Investigational New Drug (IND) is based on allogeneic ex-vivo cultured bone marrow derived mesenchymal stem cells’. After proper due diligence done by the regulatory bodies including ICMR, Stempeutics got DCGI approval for phase-I/phase-II randomized, double blind, multicentric and placebo-controlled clinical trials. “Stempeutics’ goal is to bring out stem cell-based drugs in the near future using bone marrow-derived mesenchymal stem cells. Towards this goal, we have submitted proposals for conducting large scale clinical trials of its IND application for treating AMI and CLI patients to DCGI,” added Manohar. In one of its most recent developments, Reliance Life Sciences, a yet another company working successfully towards regenerative medicine launched the first commercially available autologous limbal stem cell therapy in India, ReliNethra, to benefit Indian patients who suffer from unilateral corneal blindness. Reliance Life Sciences has also completed clinical trials after regulatory approvals, using mesenchymal stem cells derived from the patient’s own bone marrow for myocardial infarction. The company is carrying out clinical trials for application of stem cell-based therapies for stable vitiligo, non-healing diabetic ulcers, Parkinson’s disease and spinal cord injury. Reliance Life Sciences has also developed embryo toxicity services as a tool for drug development to benefit organizations developing new molecules. Reliance Life Sciences has developed several mesenchymal stem cells from different sources and CD34 cells from cord blood, which are available to researchers. Embryonic stem cell lines from Reliance Life Sciences are available from the National Center for Cell Science (NCCS), Pune, for research purposes. The year 2009 has been an exciting year for stem cell research. Early this year, US President Barack Obama reversed restrictions that former President George W Bush imposed on federal funding for stem cells in 2001.  And in an encouraging move the Food and Drug Administration (FDA) has approved the first-ever clinical trial of stem cell therapy on human subjects. The trial, funded by the biotech company Geron, will test a procedure to repair spinal cord damage. The therapy involves the injection of precursor cells into the spine, where the cells will then differentiate into oligodendrocytes, the cells type that sheathes and protects the nerves of the spinal cord. As a phase-I trial, Geron’s test will only examine the safety of the therapy, not the actual effectiveness. Dr Samuel JK Abraham, faculty of medicine, Department of Surgery, Yamanashi University and director of Nichi-In Centre for Regenerative Medicine (NCRM), Chennai, said, “The approval from DCGI is a good step forward. But, while considering the recent incidences of donor stem cell tumor in a patient treated with allogeneic neural stem cells and the tumor development in an Israeli patient treated in Russia with stem cells, we need to take lot of precautions while using allogeneic applications.  “Having a single window organization like NAC-SCRT for all cell- based therapy approval would be ideal as stem cells or cells are a lot different from a drug and are rapidly changing science needs. A dynamic team, which keeps itself updated on the developments in the field, to ensure that the approvals given in India are scientifically of international standard. NCRM has initiated discussion with an institute in the US, for taking its inventions and developments in cornea for a clinical trial followed by an application through USFDA and a collaboration in that regard will be signed within this year,” added Dr Samuel JK Abraham. While the FDA approval is an encouraging step towards the development of stem cell science, the allied developments could pave the way for more clinical trials on stem cell therapies to cure several other diseases. Activities at Stempeutics Overall Stempeutics is working on eight products covering various diseases. These eight products cover cardiovascular (AMI, CLI and DCM), orthopedics (osteoarthritis), respiratory (COPD), endocrinology (diabetes), central nervous system (cerebral stroke), and gastroenterology (liver cirrhosis) diseases for which there are no effective treatment available. Each product is at various stages of development. “While all the products are very important, we took AMI and CLI on priority basis because of the availability of more research data on AMI and CLI (regeneration of dead myocardial tissue, improvement in LVEF etc.), results shown at in-vitro research work and in pilot studies at Stempeutics, and cardiovascular diseases which will be the numero uno killer disease by 2020 according to WHO,” shared Manohar. Stem cell business is an extraordinary area which requires heavy investment for creating a world class lab for stem cell production, R&D, animal studies, and clinical trials. Stempeutics has already invested Rs 45 crore on stem cell and clinical research programs and planning to spend another Rs 70 crore in the next few years on clinical trials and pilot studies. Stempeutics has already started the AMI and CLI clinical trials. As these clinical trials being conducted at four different hospitals in India, phase-I/phase-II trials are expected to be over by March 2010 and phase-III by March 2011. Based on the results of those clinical trials the company expects to bring out the first stem cell-based drug in the Indian market by the end of 2011 or early 2012. Manipal Hospital has tied up with Stempeutics Research for promoting stem cell clinical research and pilot studies. The treatment of patients will happen at Manipal Hospital and it’s role includes – taking approval of stem cell pilot study from Hospital Ethics Committee and Hospital Stem Cell Committee as per the ICMR guidelines, patient evaluation and selection as per clinical protocol, obtaining written informed consent from the patient, conducting screening tests and if found suitable performing the actual pilot study in compliance with ICH-GCP guidelines. Focus areas While the initial foray of Stempeutics is in bone marrow derived mesenchymal stem cells, the company has been investing heavily on its R&D to bring out some innovative products, like tailor-made progenitor cells, in the near future based on adult stem cells. Stempeutics focuses on alternate sources like Wharton’s jelly and adipose tissue for mesenchymal stem cells and invests money on its long term goal of leveraging human embryonic stem cells for therapeutics purpose. To achieve this goal, Stempeutics eyes on deriving human embryonic stem cells lines. Also Stempeutics is focusing on establishing a stem cell platform for drug screening and toxicity studies for the pharma companies. “Stempeutics’ goal is to bring safe, effective and affordable stem cell-based drugs in the near future for curing diseases. We want to become an undisputed leader in the stem cell area in this part of the world,” expressed Manohar. While Stempeutics had limited its operations in Bangalore, Manipal and Malaysia, and it has plans to expand itself to the Middle East and Sri Lanka this year. Stempeutics has outsourced AMI and CLI clinical trials to Ecron-Acunova, the company will also partner with other good CRO companies for doing clinical trials of other diseases. Disease impact: AMI and CLI The study conducted by Global Burden of Diseases (GBD) reveals that the estimated mortality from coronary heart disease (CHD) in India at 16 lakh in the year 2000. Extrapolation of these numbers estimates the burden of CHD in India to be more than 320 lakh patients. Hospital statistics reveal that 20-25 percent of all medical admissions are due to CHD. The admissions due to acute myocardial infarction (AMI) are increasing in India. It has been predicted that by 2020 there would be a 111 percent increase in cardiovascular deaths in India. This increase is much more than 77 percent in China, 106 percent in other Asian countries and 15 percent in economically developed countries. The standard protocols of care for AMI usually includes immediate perfusion, optimal pain relief, oxygen, aspirin, anti coagulants, β-blockers, nitrates and ACE inhibitors. The management of cardiac risk factor such as tobacco use, hypertension, lipid levels, diabetes, weight control and regular exercise all work to reduce further atherosclerotic events. Despite these effort AMI is still the leading cause of congestive heart failure and death in developed and developing countries. A therapy that could improve the myocardial remodelling process and reduce the incidence or severity of congestive cardiac failure (CCF) following AMI would provide a significant impact in this area of unmet medical need globally. Use of stem cells is a novel treatment modality and the successful outcome of clinical trials conducted by Stempeutics will certainly have a huge impact in India and worldwide. Incidence of critical limb ischemia (CLI) is estimated to be approximately 50 to 100 patients per lakh per year and 10-40 percent of them are at the risk of primary amputation. Peripheral vascular disease of the lower extremities comprise a clinical spectrum that extends from asymptomatic patients to patients with chronic CLI that might result in amputation and limb loss. Narrowed vessels that cannot supply sufficient blood flow to exercising leg muscles may cause claudication, which is brought on by exercise and relieved by rest. As vessel narrowing increases, critical limb ischemia can develop when the blood flow does not meet the metabolic demands of tissue at rest. Critical limb ischemia is a persistent and relentless problem arising as a result of atherosclerosis or vasculitis in leg arteries which severely impairs the patient functional status and quality of life, and is associated with an increased cardiovascular mortality and morbidity. Prognosis of chronic CLI is poor and no effective treatments have been established in patients who are not amenable for the traditional revascularization therapies such as angioplasty and bypass procedures due to the inappropriate anatomy of the leg arteries or frequent reocclusion following revascularization. Therefore, it is necessary to establish novel revascularization treatment to improve the prognosis in these no-option patients globally. It was this clinical need, coupled with the advances in the understanding of angiogenesis that has led to efforts using stem cells as a novel treatment modality. Successful outcome of clinical trials conducted by Stempeutics will have huge impact in India and worldwide. Jahanara Parveen with inputs from Nayantara Som ]]> <![CDATA[â€œWe will continue to work with leading individuals and institutions in Indiaâ€?]]> https://biospectrumindia.com/news/95/2930/we-will-continue-to-work-with-leading-individuals-and-institutions-in-india.html https://biospectrumindia.com/news/95/2930/we-will-continue-to-work-with-leading-individuals-and-institutions-in-india.html Wed, 06 May 2009 12:32:00 +0530 “We will continue to work with leading individuals and institutions in India” —Indira Samarasekera, president, University of Alberta, Canada The University of Alberta gives a national and international voice to innovation in the Canadian province and takes a lead role in placing Canada at the global forefront.  In an exclusive interview Indira Samarasekera, president, University of Alberta, informs BioSpectrum Chief Editor E Abraham Mathew about the research and partnership plans of the university with India. What have been the key achievements of the University of Alberta in the life sciences and health sectors? The University of Alberta (UA) has a long track record of significant advancements in the health sciences dating back to 1921 when chemistry professor and alumnus James Collip played a key role in the development of insulin to treat diabetes. While on a research sabbatical, he refined the pancreatic extract obtained by Frederick Banting and Charles Best so that it could be used in humans. Banting and Best were awarded the Nobel Prize and many feel that Collip should have been included in that award. The university’s world-leading carbohydrate chemistry group has about 50 years of significant breakthroughs to its credit, including Raymon Lemieux’s discovery of howIndia-International.gif to make synthetic sugar (synthesizing sucrose) and how carbohydrates bind to proteins—crucial to everything from immunology to cancer. The work of Lemieux and his colleagues led to new antibiotics and blood reagents, drugs to prevent organ transplant rejection, and improved treatments for leukemia and hemophilia. More recent examples include: The development of the breakthrough Edmonton Protocol method of extracting and transplanting islet cells to treat Type 1 diabetes, freeing patients from the need for supplemental insulin for years at a time The first commercial drug treatment for hepatitis B by professor and alumnus Lorne Tyrrell, MD Molecular biologist Chris Bleakley discovered the way in which T-cells cause cell death. The University of Alberta is among the best in the world at diabetes research and is home to the Alberta Diabetes Institute, and is a leader in neonatal and transplantation medicine research working in close partnership with the local health authority to speed research from bench to bedside. Ranking of universities is common.  Where does the UA figure in such rankings in the life sciences and health related sectors? The Times Higher Education-QS World University Rankings of the year 2008 listed the UA 74 overall, 50 in academic survey rank, 88 in arts and humanities rank, 46 in engineering and IT rank, 45 in life sciences and biomedicine rank, 51 in natural sciences rank and 113 in social sciences rank. UA ranked 106 overall in the 2008 Shanghai Jiao Tong University Academic Ranking of World Universities and 62 in North America. Briefly describe the biotech work being done at the university in the field of diabetes, agriculture and fuels? There is extensive biotechnology work happening at the university.  Researchers who make discoveries with commercial potential can draw on the resources and expertise of TEC Edmonton, a joint venture between the university and the city of Edmonton to commercialize research. A significant amount of biotech work is done in the university’s NanoFab (micro- and nanofabrication facility) and the National Institute for Nanotechnology (NINT), a joint partnership with the National Research Council, the university and the province. In the words of Jillian Buriak, chemist and Canada Research Chair in Inorganic and Nanoscale Materials, “This place is a jewel in many ways. It has everything you need. The NanoFab (nanofabrication facility) is fantastic with its micro and nano fabrication equipment that is virtually unequaled in Canada — that’s the reason NINT came here instead of Montreal, Vancouver or Toronto. There’s also the Alberta Center for Surface Engineering and Science that has equipment you won’t find anywhere else in North America.” Agriculture research at UA is instrumental in supporting a diverse and economically critical agricultural sector. Food safety is one example of this sort of work.  That research is centered at the Rs 124 crore Agri-Food Discovery Place, which supports research in meat safety, crop use for food (including nutritionally enhanced food) and crop use for non-food products such as biodiesel and bioplastics.  In addition, there is extensive research and development of crop variations for disease resistance or enhanced nutrition. The researchers at the Faculty of Engineering are working on advancements in energy research, particularly in terms of energy and environment. In many cases, researchers are working closely with industry to find solutions to business needs such as clean coal technology, oil sands bitumen extraction that uses less water and produces less toxic waste, remediation of land and water used in resources extraction (e.g. coal, oil, gas). The university is home to the Imperial Oil-Alberta Ingenuity Center for Oil Sands Innovation and the multidisciplinary School of Energy and the Environment (part of the Canada School for Energy and Environment). Some specific examples include: David Wishart and his team completed the first draft of the human metabolome, the chemical equivalent of the human genome, opening the door to more targeted drug therapy. An interdisciplinary team creating a technology to stimulate the regrowth of tooth root tissue. Engineering professors developing a new type of “puffer” or inhaler that allows patients to inhale antibiotics. Robert Burrell’s development of medical uses for nanocrystalline silver (while working in the private sector, he developed the Acticoat burn dressing, considered the first commercial therapeutic application of nanotechnology in the world). Interdisciplinary teams studying prion diseases and ways to develop cost-efficient test for bovine spongiform encephalopathy (mad cow disease) and chronic wasting disease. An interdisciplinary team that developed a “lab on a chip” device that allows inexpensive and quick cellular analysis with potential applications in disease diagnosis, remote water testing and more. Chemist Jillian Buriak’s research team’s development of a silicon-based drug delivery system that has been licensed to a pharmaceutical company. Does the university have associations with Indian institutions? If yes, what is the scope? The University of Alberta has been actively developing linkages with top Indian institutions such as Indian Institute of Technology (IIT), Mumbai; the Indian Institute of Science (IISc), Bangalore; Petrotech Society, New Delhi; and Tata Consultancy Services.  In March 2009, the University of Alberta and IIT (Mumbai) signed an agreement for international research on energy and nanotechnology. We are looking forward to strengthen our research ties with the leading institutions in India.  We have also been developing our linkages in the area of executive education.  In 2008, the Petrotech Society sent 24 executives from leading Indian energy companies to UA for a customized one-week training program through our School of Business.  Another group is expected to come in 2009. Finally, through partner schools or companies such as Tata, the University of Alberta is actively exploring study, work, and research placement opportunities for outgoing as well as incoming students. Describe your India agenda if there is one? The University of Alberta is committed to develop a broad range of activities with India.  Not only are we developing strong science and technology linkages with institutions like IIT-Mumbai, we are interested in the study of India. Through a generous donation by a local Indian couple in Edmonton, Prem and Saroj Singhmar, a Chair in Classical Indian Polity and Society was established in our Faculty of  Arts several years ago.  The Faculty has also recently hired a professor of Indian religions.  At the same time, we are expanding the scholarship funds offered for undergraduate students from India.  The University of Alberta has excellent professors and facilities which help create an outstanding learning environment for students at all levels. By providing more scholarships, we hope to show Indian students what we have to offer. India is the only location outside of Alberta where our international office has a staff member. I take a very personal interest in our activities with India. I have been there twice in the past year and a half and am chairing an India Regional Council that we recently developed at the University of Alberta.  During my trip in December 2007, I was fortunate to have an opportunity to meet with the Prime Minister Manmohan Singh who has an honorary doctorate from the University of Alberta.  We will continue to work with leading individuals and institutions in India to create mutually beneficial relationships. Your roots are from South Asia.  What would be your message to South Asian companies and students? South Asia is a region of growing importance in the world and is gifted with many talented people. I myself came from Sri Lanka to North America as a student many years ago and am fortunate to have become the president of one of Canada’s top research universities. I have pursued my personal goals, and I have also laid out a vision for the University of Alberta, to become one of the top 20 public universities in the world by 2020.  I am very pleased to be engaging with South Asia, in particular India, in my role as president of the University of Alberta. I believe there are many synergies that can develop by working together, for example through research collaboration and training. I would encourage South Asian students and institutions to explore the many excellent opportunities that the University of Alberta has to offer. E Abraham Mathew in Edmonton, Canada ]]> <![CDATA[â€œPartnerships are very important for us in Indiaâ€?]]> https://biospectrumindia.com/news/95/1066/partnerships-are-very-important-for-us-in-india.html https://biospectrumindia.com/news/95/1066/partnerships-are-very-important-for-us-in-india.html Wed, 06 May 2009 12:26:00 +0530 “Partnerships are very important for us in India” —Stefan Borgas, CEO, Lonza Group, Switzerland Stefan Borgas, CEO, Lonza Group, was recently in India to inaugurate Lonza India’s new facility in Mumbai. Speaking exclusively to BioSpectrum, Borgas revealed the company’s strategy to make India a prominent player in Asia and the huge opportunities Indian market has in store for them. What are Lonza’s strategies for India, the emerging hub for R&D? We look at the Indian market in an opportunistic way to outsource raw materials and certain other products. With the inauguration of the new facility in Mumbai, we are now moving on to the next level where we will focus on Indian life sciences market. Life sciences market is still very small in India but we are looking at long term opportunities. India has a fantastic pool of intelligent and energetic people and maybe in the future we will be looking out for more sites in India. We will develop our activities over the course of 10-15 years and start research activities in three of our business areas, including biosciences, where we make products which support the researchers and biopharmaceuticals, where we offer services to the biopharmaceutical industry. We want to make India the hub of Asia within 5-6 years. Is Lonza planning to initiate any joint ventures with local companies in India? Many discussions for joint ventures are going on at the moment. We are looking at all options and are very flexible because we consider ourselves as one little piece in a network of companies. We have our specific competencies, we do have production capabilities and we can make tools for researchers but there are so many things we do not know about. That is why we believe that partnerships are very important for us in India.  How is the life sciences market scenario in the Asia Pacific region?  The life sciences market is growing in Asia. Japan and Singapore are already a part of the developed markets. The Asian markets have realized the importance of innovation. With so many brilliant brains, Asia provides huge opportunity for innovation, not only for western markets but also for local ones. Now people are realizing the need for innovation to create new things that are much better than just copying products, countries like Korea and Taiwan have shown this in other industries but not yet in life sciences. Regulations play a very important role in this development as the life sciences market deals with health of the people. What was the strategy behind biosimilars deal with Teva? What were the criteria for selecting Teva as a partner for the deal? The biosimilars deal with Teva Pharmaceuticals is simply a continuation of a 25-year-old relationship of Lonza with pharmaceutical companies all over the world. In the past two years, we spoke to all the major generic companies in the world, and we believe that Teva has strengths which are complimentary to our capabilities. The deal focuses on a limited number of biosimilars products, which Lonza wants to do exclusively for Teva Pharmaceuticals.  These products will in no way be in conflict with any of our other customers. The deal is very carefully crafted so that all the patents of Lonza will not be affected that is why the deal is called a ‘limited collaboration’. Despite the currency fluctuations and other financial turmoil in 2008, Lonza showed a 13 percent hike in sales, what were the reasons behind the stability? Our long term collaborations are considered as the main reason. Once we start working with customers usually we do not see any sales for 2-3 years or even longer, but when business starts to come in then it does not go away for 6-12 years. We give emphasis to long term business. In the life sciences space the demand is usually stable.  What is the impact of recession on life sciences sector? In general sectors like biopharma don’t have much of a demand problem. But there is an issue of funding start-up biotech companies around the world; this demand is very much driven by the start-up companies that are in need of funding. This dearth of financial backing is also affecting India and other countries; because of this the ongoing projects will get delayed. The second effect is felt in the western countries, where there is a significant reduction in public funding for healthcare research which has always been a driver of innovation. Will recession affect Lonza’s investment in 2009? Recession will not be a setback for any of our investments. We have carefully thought about this and from the investments side we have decided not to slow down any of our initiatives. We are more careful in larger scale acquisitions and we are eager in small scale acquisitions. We are investing around Rs 2,473 crore this year for all our investments. How has the life sciences industry matured over the years and how have the dynamics changed? We are seeing an evolution of partnerships and the maturing of the industry over the past few years. In the beginning, companies looked out for partners for special technologies where they did not have any competency. Then they looked at third party partnership in order to reduce costs and that is how the outsourcing industry started and now in the next phase we are looking at the entire spectrum of the development process because there is much more leverage there. So what happened in the electronics 10 years earlier and automobiles industry 20 years ago is now happening in the life sciences industry. Being in the business for a long time, how do you view the contract manufacturing market in this period of recession? More consolidation will happen in the contract manufacturing market with a significant focus on environmental protection. The Chinese were the first one to drive in, now we will see India coming into this field. Focusing on development will help companies to get stronger. On the other hand weaker players may step out of the market and the current economic and credit crunch will support it. We have seen a lot of companies that have stepped out of this market in the last five years. More clean up will happen inside the pharma companies as well. Is Lonza planning to set up manufacturing facilities in India? Yes, we are planning to develop our labs and soon we will downstream into manufacturing as well. We have a pipeline which supports these developments.  What are the product lines to be introduced by Lonza in India? We have a lot of products in bioscience cell discovery division which will help researchers in India to more effectively test drugs not only on animal cells but also on human cells by giving much better prediction models. Globally we have set ourselves in this technology but it is not so well spread in India and Asia and this is one product we want to introduce with a big focus here as in 2009-10 How would you compare the growth of Lonza in India and China? Lonza established its first production capacities in China in 1986. China has had a more constant growth than India. China has the advantage of having a centralized government structure, which supports infrastructure and certain strategic industries. Owing to this centralized government structure, investments of the Chinese government happen in a more consolidated and faster manner. In India, I think the development is more sustainable because we are looking at grassroots, and India also has the advantage of education. Nayantara Som ]]> <![CDATA[â€œWe aim to be world's leading provider of vaccines,â€?]]> https://biospectrumindia.com/news/95/2500/we-aim-to-be-worlds-leading-provider-of-vaccines.html https://biospectrumindia.com/news/95/2500/we-aim-to-be-worlds-leading-provider-of-vaccines.html Wed, 06 May 2009 12:15:00 +0530 “We aim to be world’s leading provider of vaccines,” —Weidong Yin, chairman, president & CEO, Sinovac Biotech, China Sinovac Biotech, also known in China as Beijing Kexing Bioproducts,  specializes in the research, development, commercialization, and sales of human vaccines for infectious illnesses such as hepatitis A,  hepatitis B, influenza and SARS. Working closely with Chinese public health officials, Sinovac focuses on manufacturing and marketing human-use vaccines and related products. Sinovac is currently developing a universal pandemic influenza vaccine and Japanese encephalitis vaccine. Sinovac is the first and currently the only company in the world to have been granted permission to begin clinical trials for a vaccine to prevent SARS. Recently, as a testimonial to its commitment towards quality products,  the company has received Good Manufacturing Practice (GMP) certification for its newly opened filling and packaging production facility. In an interview with BioSpectrum,  Weidong Yin, chairman, president and CEO of  Sinovac Biotech, elaborates on the company’s endeavors and the vaccine market in China. What do you see as Sinovac’s competitive advantage? I believe, Sinovac has the management flexibility compared to big companies. The company has multiple sources of financing as well as standardized and transparent management through public listing in the US stock market. The local production provides cost advantages. Full understanding of market demands in China enables Sinovac to achieve strong market penetration. Sinovac has strong R&D capabilities. Compared with other Chinese companies, Sinovac is more open to collaboration and it has a clear mission of targeting the improvement of China’s public health. What do you see as Sinovac’s competitive advantage? I believe, Sinovac has the management flexibility compared to big companies. The company has multiple sources of financing as well as standardized and transparent management through public listing in the US stock market. The local production provides cost advantages. Full understanding of market demands in China enables Sinovac to achieve strong market penetration. Sinovac has strong R&D capabilities. Compared with other Chinese companies, Sinovac is more open to collaboration and it has a clear mission of targeting the improvement of China’s public health. Can you elaborate on the vaccine market in China as such and where Sinovac is positioned in the industry? China’s vaccine market can be divided into two sections, namely the public market and private market. In the public market, vaccines are mainly purchased by the central government. Both central and local governments provide centralized financial allocations for the public market. In the private market, the purchases are made by individuals, and include Sinovac’s adult and pediatric vaccines. In addition, the private market also includes vaccines for special groups, such as rabies vaccines and hemorrhagic fever vaccine. The vaccine market in China is expanding rapidly. Since the open of the private market, domestic vaccine market has grown at a 15 percent annual growth rate, which is much higher than global average number of 10 percent. The market scale in 2006 was about Rs 3.34 lakh crore ($670 million), of which more than Rs 1.93 lakh crore ($388 million) came from the private market. With the public’s increasing attention to vaccination, the private market is expected to continue to develop rapidly. In addition, purchases from the government and the development of novel vaccines (improved vaccines) are encouraging the development of the vaccine market. It is estimated that the annual growth rate will be more than 20 percent in the future. By 2010, China’s vaccine market scale may achieve Rs 7,312-8,777 crore (10—12 billion RMB). Sinovac is a leading vaccine biological company, and the largest supplier of hepatitis A inactivated vaccines in China. We enjoy advantages in the R&D, standardized management and financing capability.Ajeesh Anand How strong is your customer base in China? What are the other markets in focus?  In the market of planned immunization, China has a huge base of population of more than 130 crore. Vaccine usage is changing with the fluctuation of the annual birth rate. There is a big potential developing market with 1.5 crore newborns each year. Regarding the private market, Sinovac’s principal consumers are the 20—30 crore people living in developed areas. Sinovac has in-house sales team, including 91 sales professionals covering 30 provinces and cities in China. Other than China, Sinovac plans to export products to developing countries. Currently, we are exploiting international markets with two of our products, hepatitis A vaccine and influenza vaccine. Ajeesh Anand Can you update us on your product pipeline? Please elaborate on the status of Japanese encephalitis, H5N1 and SARS vaccines? Currently, we have disclosed six projects in our pipeline, namely universal pandemic influenza vaccine, EV71 (hand, foot and mouth disease) vaccine, hepatitis C vaccine, JE (Japanese Encephalitis) vaccine, rabies vaccine and pandemic influenza vaccine. Our R&D team actively provides momentum to project development. Since the R&D process of vaccines is relatively complex and long-term work, Sinovac plans to launch one or two products each year during 2012 and 2020. Pandemic influenza whole virus inactivated vaccine, Panflu, obtained a production license from the China SFDA in April 2008. We have also completed volunteer enrollment for the split pandemic influenza inactivated vaccine in the third quarter of 2008. Sinovac anticipates the preliminary results in early 2009. The Japanese Encephalitis vaccine is in the preclinical research stage. We believe our production technology can increase manufacturing yield, simplify operations and stabilize cultivation conditions, all of which facilitate large-scale automated production.  We had  completed phase-I clinical trial for SARS vaccine in December 2004. Recently Sinovac has received approval from China’s Ministry of Agriculture to conduct trials of rabies vaccine. Can you throw more light on this? How do you see the market opportunities for veterinary vaccines in China? Sinovac’s wholly owned subsidiary, Tangshan Yian Biological Engineering Co, is entering the veterinary vaccine market in China by developing a domestically produced inactivated rabies vaccine which will be one of the first inactivated versions to be developed in China. We anticipate that the field trials for the inactivated animal rabies vaccine will take approximately nine months to complete and that the vaccine will be launched in China’s veterinary market in 2010. The move indicates that, while Sinovac will maintain its leading position in the human vaccine market, the company is expanding into a related business area that allows it to leverage its core competencies in vaccine R&D and production. Tangshan Yian obtained approval from China’s Ministry of Agriculture to conduct field trials of its internally developed inactivated animal rabies vaccine with independent intellectual property rights in early 2009. Farming output in China is significant and rapidly growing. Given the human health hazards associated with animal diseases, China’s government is raising investment in the prevention and control of animal diseases. From 2000-08, foot and mouth disease, bird flu, swine fever and swine blue ear disease have been included in the compulsory vaccination program. The compulsory vaccination program has lead to the creation of a number of animal health enterprises with an annual value of over Rs 364.43 crore (500 million RMB). The Chinese government continues to expand the scope of the veterinary vaccination program. Huge farming output and the expanding veterinary vaccination program are creating market opportunities. What are the major challenges from the industry? What is your strategy to tackle those challenges? I believe the major challenges for the vaccine industry are linked with the challenges to human health. Our mission is to supply vaccines to eliminate human diseases. Our major challenges are meeting the public’s demand for safe and effective vaccines against diseases, like SARS and bird flu.  We are in a leading position in the research and development of vaccines. At the outbreak of SARS, we are the first and only company to have completed phase I clinical trials. When human cases of the H5N1 virus are reported, we promptly advanced the R&D of a vaccine against the virus. In other words, Sinovac’s strategy is to monitor our R&D capabilities and to increase investment on R&D. More importantly, since we put efforts into cost control, we can supply high quality vaccines at a relatively low cost.  What sort of impact Sinovac has due to the global economic crisis? How do you see the future of Sinovac? China is also affected by the global financial crisis that hit the world in 2008. The biopharmaceutical industry relates to people’s livelihood, though demand for biopharmaceutical products is somewhat rigid. The biopharmaceutical industry is less affected by macro-economy, but rather controlled and affected by industry policies. Under the shadow of the dim world economic view, the crisis has had a relatively small influence over the biopharmaceutical industry. Sinovac’s operation has not been affected by the crisis. Since Chinese citizens are increasing their standards for health and quality of life, and the Chinese government is gradually increasing its support  for innovative enterprises, space for development of Sinovac will enlarge accordingly. The ultimate objective of Sinovac is to become a leading provider of vaccines in the world.  Ajeesh Anand ]]> <![CDATA[Waxman Biosimilars Bill, implications for the biotech industry]]> https://biospectrumindia.com/news/95/2865/waxman-biosimilars-bill-implications-for-the-biotech-industry.html https://biospectrumindia.com/news/95/2865/waxman-biosimilars-bill-implications-for-the-biotech-industry.html Wed, 06 May 2009 12:09:00 +0530 Waxman Biosimilars Bill, implications for the biotech industry On March 11, 2009, Henry A Waxman (D-Calif.), chairman of House Committee on Energy and Commerce;  Frank Pallone (D-N J), Nathan Deal (R-Ga), and Jo Ann Emerson (R-Mo), introduced the bipartisan “Promoting Innovation and Access to Life-Saving Medicine Act” (H R 1427) that is intended to give the US Food and Drug Administration (US FDA) the authority to approve biosimilar versions of biotech drugs. The bill provides the approval of biosimilar products that are defined as “no clinically meaningful differences between the biological product and the reference product” as well as “interchangeable” biosimilars, defined as a product that can be “switched one or more times” with the reference product “without an expected increase in the risk of adverse events”. The bill also provides incentives for brand companies to develop new therapies. Specifically, similar to the current structure for approved drugs, the bill would provide five years of exclusivity for a novel molecular structure before any biosimilar could be approved. The bill also provides three-year exclusivity for certain modifications of a previously approved product (such as a new condition of use) and a six-month pediatric exclusivity period. These exclusivity provisions are a change in direction for Waxman, as his biosimilar bill put forth in the 2007 Congress (H R 1038) provided no exclusivity for brand biologic products. Finally, Waxman’s bill also provides first biosimilar applicants with at least six-month exclusivity period if an interchangeable biosimilar product is approved. Senator Susan Collins (R-Maine) announced that she will co-sponsor the senate version of the bill, expected to be introduced soon by Senators Charles Schumer (D-N.Y.) and Sherrod Brown (D-Ohio). The bill provides the approval of biosimilar products that are defined as “no clinically meaningful differences between the biological product and the reference product” as well as “interchangeable” biosimilars, defined as a product that can be “switched one or more times” with the reference product “without an expected increase in the risk of adverse events”. The bill also provides incentives for brand companies to develop new therapies. Specifically, similar to the current structure for approved drugs, the bill would proviKiran.gifde five years of exclusivity for a novel molecular structure before any biosimilar could be approved. The bill also provides three-year exclusivity for certain modifications of a previously approved product (such as a new condition of use) and a six-month pediatric exclusivity period. These exclusivity provisions are a change in direction for Waxman, as his biosimilar bill put forth in the 2007 Congress (H R 1038) provided no exclusivity for brand biologic products. Finally, Waxman’s bill also provides first biosimilar applicants with at least six-month exclusivity period if an interchangeable biosimilar product is approved. Senator Susan Collins (R-Maine) announced that she will co-sponsor the senate version of the bill, expected to be introduced soon by Senators Charles Schumer (D-N.Y.) and Sherrod Brown (D-Ohio). Patent disputes addressed The bill would establish a procedure for resolving patent disputes before a biosimilar is approved, and would establish penalties for failure to litigate patents in a timely manner. It also presents patent dispute provisions similar to those proposed in H R 1038. Under the current bill, a biosimilar applicant has discretion to send a written request for patent information to the BLA holder. Within 60 days, the BLA holder must provide the applicant a list of all patents relating to the approved product, including patents claiming the biological product, formulations, and methods of using and manufacturing the product, even if the claimed methods for manufacturing are not used to make the reference product. The BLA holder must update the patent list for two years after receiving the request. At any time thereafter, the biosimilar applicant may provide notice of the biosimilar application with respect to one or more patents, either listed by the BLA holder or not. This notice, which the applicant sends to the BLA holder, patent owner, and the Federal Trade Commission (FTC), must include a detailed statement of the factual and legal basis for applicant’s belief that the listed patents are invalid, unenforceable, or not infringed. Within 45 days of receiving the biosimilar applicant’s notice, the BLA holder or patent owner may sue for patent infringement, but only with regard to patents listed in the notice. If the BLA holder or patent owner does not file suit within 45 days, the biosimilar applicant may bring an action for declaratory judgment that the patents are invalid or not infringed. If the BLA holder or patent owner sues after 45 days, the BLA holder or patent owner is entitled to damages only in the form of reasonable royalties in the event that a court finds infringement by the applicant. The bill also states that if a patent owner or licensee fails to disclose a patent in response to an applicant’s request for patent information in a timely manner, the patent owner or licensee may not bring an action “under this title” for patent infringement. Major battle looms The Waxman bill has broad support from varied groups, including the Generic Pharmaceutical Association (GPhA), which “applauded” the introduction of the bill; Consumers Union, American Association of Retired Persons (AARP), National Organization for Rare Disorders, Coalition for a Competitive Pharmaceutical Market, General Motors, Express Scripts, Inc., National Business Group on Health, American Federation of Labor and Congress of Industrial Organizations(AFL-CIO), and Service Employees International Union (SEIU). However, the Biotechnology Industry Organization (BIO) described the Waxman bill as “filled with potholes,” and has previously stated its position that a 14-year exclusivity period is necessary to provide adequate protections for continued research and development of novel biologic products. Other competing bills Representative Anna Eshoo (D-Calif.) and House Committee on Energy and Commerce ranking   member Joe Barton (R-Texas) are expected to reintroduce the legislation, the “Pathway for Biosimilars Act” (PBA), that would award brand companies 12 years of protection from generic competition and an additional two years of protection for an approved new indication, which is a “significant improvement” over other marketed products. The PBA also would provide six-month exclusivity for study in pediatric populations. The PBA does permit FDA to determine interchangeable products, and would grant at least two years of exclusivity for the first approved interchangeable biosimilar product. The PBA places requirements on FDA to issue proposed guidance documents for public review, issuance of final guidance prior to waiving clinical trials for immunogenicity of any biosimilar, prior to the approval of any interchangeable biosimilar; and initiate a proceeding for issuance of a guidance with respect to a product class prior to accepting a biosimilar application for review. Further, such application may not be approved until such final guidance is completed. Publication of such guidance would likely have the effect of slowing the submission and review process of biosimilars. The PBA differs from the current Waxman bill in several respects as it relates to patent dispute provisions. For example, in the PBA, relevant patents include those having claims directed to the biosimilar product, material used in the product manufacture or methods of treatment, but not methods of manufacturing the product. In addition, the biosimilar applicant does not have discretion to act under the PBA, but instead must provide the bond ledger account (BLA) holder a copy of the biosimilar application and product and production information. Within 60 days of receiving the application and information, the BLA holder must provide the applicant a list of relevant patents. The PBA also requires FDA to publish a notice within 30 days of accepting a biosimilar application. Any time after FDA publishes its notice, a third party patentee may provide notice to the biosimilar applicant identifying at least one patent. Within 30 days of receiving that notice, the biosimilar applicant also must send the patentee a copy of the patent application and product or production information. Within 90 days thereafter, the patentee must provide a list of relevant patents to the applicant. The BLA holder or patentee must explain in writing why a listed patent would be infringed. Within 45 days of receiving the list, the biosimilar applicant must send a written statement regarding each listed patent that either states that the applicant will not market until after the patent expires, or provides an explanation why the patent would not be infringed, or is invalid or unenforceable. Within 60 days of receiving the patent list the BLA holder or patentee may sue for patent infringement. Also in contrast with the Waxman bill, the biosimilar applicant may only bring a declaratory judgment action on the date that is either three-year before the 12-year exclusivity period for the brand company or 120 days after the submission of explanation by the applicant. A look ahead Given the broad disagreement on major components of the bill between both industry and congressional members, negotiation and compromise will still be necessary in order to pass this complex legislation. With other pressing issues before the House Committee on Energy and Commerce, including universal health care and climate change, it remains to be seen when this bill will gain the full attention of the committee. In addition, H R 1427 was referred to the House Committee on the judiciary, so there is more than one committee playing a role. On the senate side, compromise on a bill will be essential, as procedural hurdles in the senate ensure that passage will require 60 votes. Thus, although there appears to be a consensus that biosimilar legislation will pass this congressional session, this is simply the first, albeit important, step in the process. Obama administration has voiced support for biosimilar legislation, and as a candidate, Obama supported shorter exclusivity periods for branded biologics than those proposed by BIO, but has yet to weigh in on specifics involving the bills. Narayanan Suresh and Nayantara Som with inputs from Jahanara Parveen and Shalini Gupta ]]> <![CDATA[The door opens slightly for biosimilars in US]]> https://biospectrumindia.com/news/95/1813/the-door-opens-slightly-for-biosimilars-in-us.html https://biospectrumindia.com/news/95/1813/the-door-opens-slightly-for-biosimilars-in-us.html Wed, 06 May 2009 12:00:00 +0530 The door opens slightly for biosimilars in US A simple US legislation, the Drug Price Competition and Patent Terms Restoration Act of 1984, popularly called the Hatch-Waxman Act, allowed the entry of generic pharmaceuticals and spawned the growth of the global generics pharma industry now estimated at Rs 9.99 lakh crore. The world has been waiting for an encore on biosimilars or follow-on-biologics.  Now there is a flood of legislative proposal that seek to permit the sale of copy cat or generic versions of many life-saving biotechnology drugs. A flurry of legislative activity on this front to allow the entry of biosimilar drugs had started after Democratic leader Barack Obama assumed office as the President of the US in January 2009. He had publicly supported the entry of biosimilar drugs to enhance reach, increase affordability and reduce medicare costs. A few bills to authorize the drug regulatory, the Food and Drugs Administration (FDA), were introduced in March. But the most  significant proposal came from Senators, Charles E Schumer, a New York Democrat, and Orrin G Hatch, a Utah Republican, through a proposal called S. 726, have sought permission for biosimilars. Their legislative proposal will be a companion piece for the Hatch-Waxman Act and has suggested several far-reaching measures. The proposal is supported by other influential senators like Susan Collins, Sherrod Brown, Mel Martinez, Debbie Stabenow and David Vitter. The Schumer-Hatch proposal seeks to reduce the exclusive marketing period given to patented  biotech drugs from the current 14 years to just five years. The legislation, introduced on March 26, has caught global attention because of this drastic proposal on patent exclusivity period. The US legislature has now adjourned for summer vacation but the last minute proposal is a clear step to prepare the ground for the introduction of biosimilars when the legislature reassembles in a few months.  With both Democratic and Republican Senators proposing such a legislation and the President who has to finally approve it, favoring such a popular step, analysts are confident that biosimilars will be a reality in the US market place sometime in the year 2010.  More significantly, the Schumer-Hatch proposal has overshadowed two other competing legislative proposals introduced in the US Congress in early March. On March 11, 2009, a bill, H. R 1427, titled, “Promoting Innovation and Access to Life-Saving Medicine Act,” was introduced in the US House of Representatives by Henry Waxman with support from Frank Pallon, Nathan Deal and Jo Ann Emerson.  A week later, on March 11, another proposal, H.R. 1548, known as “Pathway to Biosimilars Act” was introduced in the same legislature by Anna Eshoo, Jay Inslee and Joe Barton. The US biotechnology industry is strongly opposed to the proposal to allow the entry of biosimialr products. Nearly half-a-dozen blockbuster biotech drugs are expected to reach their patent expiry stage in 2011 and these have annual sales exceeding Rs 55,092 crore ($11 billion).  Top biotech companies like Amgen and Genentech will be impacted severely by the entry of biosimilars.  “This legislation sets a path that jeopardizes our ability to help meet President Obama’s call for a cure to cancer ‘within our time’ and help realize the promise of stem cell research. This bill seeks to cut prices but instead cuts corners. This proposal leads us off the map as we seek an effective, fair and safe pathway to the biosimilars market,” said Jim Greenwood, the president of biotech industry lobby group, Biotechnology Industry Organization (BIO), based in Washington DC.  However, consumer activists and generic drug companies are ecstatic about the proposed entry of biosimilars. “The crushing cost of biologic drugs is leaving far too many Americans without access to life-saving treatments for devastating illness like multiple sclerosis and cancer,” said Nancy LeaMond, vice president of American Association of Retired Persons (AARP), in an interview to the New York Times. Added   Dr Dhananjay Patankar, chief technical officer, Intas Biopharmaceuticals Limited, India,  “The bill addresses lot of things which are good for biosimilar manufacturers and provides three options to them that include biosimilar without interchangeable, which is similar to the European approach; biosimilar with total interchangeable (termed as biogeneric), this is one step ahead of European Medicines Agency (EMEA) as it has left the interchangeability to the member states, the bill thus clearly introduces the idea of interchangeability; and lastly, dissimilarity in safety, purity and potency. The provisions of the bill could allow variants of existing biologics to be approved through an abbreviated process. This is the first time “biogeneric” as a term has been officially used. For a long time the term itself was considered invalid.” A regulatory pathway for biosimilars in the US and Europe could completely change the dynamics of the biotech industry.  According to a report by PricewaterhouseCoopers (PWC) titled, ‘Opportunities and barriers in the biosimilar market: Evolution or revolution for generics companies?’, biopharmaceutical drugs or biologics have outperformed the pharmaceutical market largely due to two factors: they address areas of clinical need that are unmanageable with conventional therapeutics including many cancers and genetic diseases, and biosimilars are able to command a premium price. At some point the patents protecting the successful biologic will expire and the potential of a sizable market will attract generic companies. Some of the leading biosimilar products or targets include erythropoietin, granulocyte-colony stimulating factor (G-CSF), interferon alpha, interferon beta, human growth hormone, and recombinant human insulin. The provision for exclusivity period of first biogeneric (with interchangeability) will help the biosimilar companies to develop high quality drugs and it also recognizes the fact that analytical and clinical studies can be designed to prove complete equivalence. While predicting the outcome of the final bill Dr Patankar stated, “Similar to EMEA, product-specific guideline with respect to the non-clinical and clinical requirements should be specified. Also a clear guideline with respect to requirements for the biosimilar and biosimilar with complete interchangeability has to be specified for each product. Similar to EMEA all the comparabilities of quality, safety and efficacy are required with reference product. However it is not specified that the reference product has to be from the US, the industry needs one reference medicinal product for the US and the European Union.” “Data exclusivity is an important element of the bill, the key would be to get clear guidelines for the introduction of biosimilars in the US, with definite time lines. If the final bill is passed in its current form, it will dramatically alter the face of the biotech industry and existing biotech giants will have to face competition for the first time in their market. The introduction of biosimilars would bring down the cost of medicines for critical diseases in the US and make them available to a wider population,” said KV Subramaniam, president and CEO, Reliance Life Sciences, India.   Favorable for India companies Indian Biotech Inc. has lauded the bill with the contention that this can open up new avenues and markets for Indian companies that have already ventured into biosimilars. Dr MK Sahib, director, Genomics and Biotechnology, Wockhardt, India, said, “The biosimilar bill definitely brings good news for those Indian companies that have already ventured into the space and have filed Abbreviated New Drug Applications (ANDAs) in the US,  the bill will give them an upper hand over those who are not focusing on biosimilars space.”  “The US is the largest market for biopharmaceutical products, accounting for about 50 percent of global sales. The biosimilar bill will allow Indian companies operating in the biosimilars space to gain access to the largest market in the world for their products. This is a positive sign for domestic biopharmaceutical companies,” commented Subramaniam. Reliance Life Sciences has launched three biosimilars-ReliPoietin [Erythropoietin (EPO)], ReliGrast [Granulocyte colony stimulating factor (GCSF)], and ReliFeron (Interferon Alpha 2b) in the domestic market in 2008. Reliance Life Sciences is currently working on a range of biosimilars, which are at different stages of development viz. clinical trials, pre-clinical studies, process development and molecular biology. “We are concurrently conducting clinical trials for two biosimilars - EPO and GCSF - in Europe. Further, Reliance Life Sciences has built significant manufacturing capacity for biopharmaceuticals and all these facilities are compliant with USFDA and EMEA standards. Also, Reliance Clinical Research Services (RCRS), the contract research organization (CRO) arm of Reliance Life Sciences, is capable of conducting clinical studies for these products in multi-country setting and as per ICH-GCP protocols,” added KV Subramaniam. Moreover, despite Obama vouching in for cheap healthcare, several experts opine that the age of generics is over. “The biotech companies in the US have mastered themselves in small molecules, which have provided a good opportunity for them all this while. Biosimilars on the other hand is limited to a small number of players in the market, so the competition is comparatively low, this will be a great boost for biosimilar players in the market,” added Dr Sahib. Generics did have a revolutionary impact but experts opine that biosimilars will have much more impact if a regulatory pathway is chalked out. It will definitely not be a cakewalk for Asian companies despite the attractive prospects that the biosimilar markets offer. A PWC report points at two important challenge areas. Firstly sales of most biopharmaceuticals are higher in the US than the rest of the world. However, there is unlikely to be a regulatory pathway for most biosimilars in the US until after 2010. The commercial decision on the new products will be taken on the basis of the sales a biosimilar can generate in Europe. The biosimilar market will be characterized by price competition, even when there is only one or a very limited number of players for a given product, this will constrain the size of the commercial opportunity. Manufacturers of branded products are likely to use sophisticated defensive tactics, including the development of complex biopharmaceuticals, to make their presence felt in the market. Indian companies including those companies that have ventured into biosimilar space should have to find a solution to overcome these obstacles before setting out to exploit the US market. Narayanan Suresh and Nayantara Som with inputs from Jahanara Parveen and Shalini Gupta   ]]> <![CDATA[â€œRadiosurgery treatment can be completed in 3-5 daysâ€?]]> https://biospectrumindia.com/news/95/2211/radiosurgery-treatment-can-be-completed-in-3-5-days.html https://biospectrumindia.com/news/95/2211/radiosurgery-treatment-can-be-completed-in-3-5-days.html Wed, 08 Apr 2009 13:04:00 +0530 “Radiosurgery treatment can be completed in 3-5 days” —Dr John R Adler, president, CyberKnife Society Dr John R Adler, is the inventor of CyberKnife Robotic Radiosurgery System. He has been a member of the faculty at Stanford University and a professor of neurosurgery and radiation oncology at Stanford University School of Medicine since September 1998. He is also the president of CyberKnife Society. Dr Adler started the company Accuray to commercialize his scientific development. Though Accuray manufactures the CyberKnife System the patent for this technology was sold to Stanford University in 1994. CyberKnife is the first and the only non-invasive radiosurgery system available globally. In India, HCG offers CyberKnife whole body robotic radiosurgery therapy . Will you tell us about the CyberKnife technology and its applications? The CyberKnife Robotic Radiosurgery System is a non-invasive alternative to surgery for the treatment of both cancerous and non-cancerous tumors anywhere in the body, including prostate, lung, brain, spine, liver, pancreas and kidney. The treatment delivers beams of high dose radiation to tumors with extreme accuracy. CyberKnife is offering a new hope to patients worldwide as the treatment is devoid of any surgery. In fact, the CyberKnife system is the world’s first and the only robotic radiosurgery system designed to treat tumors throughout the body noninvasively. The technology offers new hope to patients who have inoperable or surgically complex tumors, or who may be looking for an alternative to surgery for cure many small tumors and a few other medical disorders. Unlike other radiosurgery systems, which are primarily used for the treatment of head cancers, CyberKnife can deliver radiosurgery to any part of the body. The system also gives some added benefits to patients, including pain free treatment, no anesthesia, less recovery time and lower risk of radiation damage to normal tissues. Is CyberKnife technology purely based on radiation therapy for treating tumors? Yes. In this kind of treatment the patient is imaged using a high-resolution CT scan to determine the size, shape and location of the tumor. Following scanning, the image data is digitally transferred to the workstation of CyberKnife system, where the treatment planning begins. A qualified doctor then uses the CyberKnife software to generate a treatment plan. The plan is used to match the desired radiation dose to the identified tumor location while limiting radiation exposure to the surrounding healthy tissue. Then the CyberKnife System’s computer-controlled robot will slowly move around the patient to the various locations from which it will deliver radiation to the tumor. What are the advantages of CyberKnife over conventional radiotherapy? Conventional radiation therapy administers a broad beam of radiation from one or two directions in 30 to 45 treatments. It delivers low dose beams of radiation over a period of 6-8 weeks. Whereas CyberKnife radiosurgery delivers high dose beams of radiation, which can be more effective in killing tumors anywhere in the body. This system can deliver radiation beams from virtually unlimited directions with sub-millimetre accuracy. Radiosurgery minimizes the damage to the surrounding tissues and therefore the treatment can be completed in 3-5 days. What is the time taken for the treatment using CyberKnife? Each treatment session lasts between 45 to 90 minutes, depending on the type of tumor being treated. If treatment is being delivered in stages, patients will need to return for additional treatments over several days (typically not more than five days), as determined by the doctor. What about the side effects? It has no side effects. In a few cases, patients may experience some minimal side effects, but those often go away within a week or two after treatment. How do you plan to expand the use of this technology globally? CyberKnife has been there since 1994. The current one is the fourth generation technology. To date, more than 50,000 patients have been treated and more than 155 systems are installed worldwide. We have been waiting for the improvements to come and now we are happy to introduce the same machine here in India. Introducing CyberKnife treatment in India for the first time is a huge milestone in achieving broader access to the benefits of radiosurgery. Technology drives up the cost of healthcare. But CyberKnife when properly used is less expensive than all other technologies. With early detection, it is capable of curing 100 percent of cancer. CyberKnife facts Approved by USFDA in 2001 to treat tumors and lesions anywhere in the body when radiation treatment is required. Over 155 CyberKnife systems currently operating in the world. Over 50,000 patients have been treated successfully. Currently more than 50 percent of all CyberKnife procedures in the US are extracranial. Jahanara Parveen ]]> <![CDATA[Biotechs weathering the storm]]> https://biospectrumindia.com/news/95/2945/biotechs-weathering-the-storm.html https://biospectrumindia.com/news/95/2945/biotechs-weathering-the-storm.html Wed, 08 Apr 2009 12:28:00 +0530 Biotechs weathering the storm Biotechs weathering the storm Things are looking up for the few dozen global biotech companies, including some of India’s leading players, who have invested heavily to make biosimilar drugs.  The world’s biggest pharmaceutical market, the US,  is taking some tentative steps to keep the doors open for biosimilar drugs. A new legislation introduced on March 26 in the US senate, with support from both the Republican and Democratic party, seeks to make things easy for the entry of biosimilar versions of expensive, patented biotechnology-based drugs.    The legislation proposes to provide discretionary powers to the US regulatory, the Food and Drugs Administration (FDA), to approve biosimilar products. Europe had allowed selective entry of  biosimilars a few years ago and policy makers, opinion leaders and healthcare activists have been campaigning relentlessly for the entry of biosimilar for some time now to increase affordability of many of the life-enhancing drugs made through the biotechnological route. During his campaign phase, US President Barack Obama had stressed the need to lower medical costs and his administration is likely to override objections of the Big Pharma against biosimilar drugs.    A significant number of Indian biotechnology companies have been preparing for the much-awaited support to biosimilars in the world’s largest market and many business plans were based on such a scenario. All these companies can now wait for the golden opportunity. In fact, companies like Biocon, Serum Institute, Shantha Biotech, Bharat Biotech, Panacea Biotec and new entrants like Lupin, Glenmark could benefit immensely in the long run by the imminent opening of the doors for biosimilars in the US market.   Shantha has started work on a new manufacturing facility for biologicals. Serum too is ramping up the capacity. Biocon has just completed an expansion project. Many pharma companies have dusted up their biotech plans. Dr Reddy’s has introduced two biotech products and is working on at least eight more biosimilars. Wockhardt’s biotech unit is up for grabs as the company tries to reduce its debt burden and at least two global majors are eying this unit.   While biosimilar scene is hotting up, Bangalore-based Manipal Group company, Stempeutics, has got the regulatory approval to start clinical trials of a stem cell based drug to treat cardiovascular conditions.    And the biotech crop scenario is also looking up with India moving up the ladder to become the world’s fourth largest grower of biotech crops. This is happening even as the opponents of biotech crops are upping the ante to stall the entry of the country’s first biotech food crop, a Bt brinjal variety. The year 2008 had been a year of robust growth for biotech crops according to the latest report released by the International Service for the Acquisition of Agri-biotech Applications (ISAAA). From six countries growing biotech crops in 1996, today the number is 25 and more and more developing nations are adopting transgenic crops. In 2008, the global hectarage of biotech crops reached 125 million hectares, up from 114.3 million hectares in 2007,  which is 10.7 million more hectares (the sixth largest increase in 13 years) . The year also saw the planting of the second-billionth acre (800 millionth hectare) of a biotech crop – only three years after the first one-billionth acre of a biotech crop was planted in 2005 which took 10 years. In 2008, two-thirds of the 25-biotech countries planted biotech maize, 10 biotech soybean, 10 biotech cotton, and three countries planted biotech canola. Over 13.3 million farmers benefited from Bt crops. According to the report, the future surely belongs to Bt crops with more than 40 countries expected to adopt biotech crops, with 15 or more new countries projected to plant biotech crops for the first time during 2009-15 The results of a consumer survey conducted by the Asian Food Information Center (AFIC) indicated that Indian  consumers are ready to embrace biotech foods. This is  good news for farmers who intend to grow Bt brinjal, Bt rice, and other transgenic food crops when the regulatory clearances are given. Bt rice could be launched in India by 2011–12 according to the ISAAA report. Rice is the second most consumed cereal grain, after maize, for a large part of the world’s population and Bt rice is almost ready for adoption (pest/disease resistant biotech rice) in China. With over 43 million hectares, India has the largest rice acreage in the world and is the second largest producer of rice with production at 96.43 million tonnes in 2007-08. Things are indeed looking up for the biotech sector. <sureshn@cybermedia.co.in> ]]> <![CDATA[â€œIndia has shown great interest in advancing the science of stem cell biologyâ€?]]> https://biospectrumindia.com/news/95/2650/india-has-shown-great-interest-in-advancing-the-science-of-stem-cell-biology.html https://biospectrumindia.com/news/95/2650/india-has-shown-great-interest-in-advancing-the-science-of-stem-cell-biology.html Wed, 08 Apr 2009 11:39:00 +0530 “India has shown great interest in advancing the science of stem cell biology” —David Smoller, president, Research Biotechnology Business, Sigma Aldrich Sigma Aldrich, the US based life science and high technology company, has recently announced the launch of an online web portal that provides researchers with immediate access to its extensive portfolio of over 1,100 industry-leading products developed specifically for advanced stem cell research. In addition, a team of regenerative medicine experts has been retained to identify and develop new and promising technologies in this growing area. This comes in the wake of  lifting of the ban on stem cell research and companies showing willingness to realize their potential in the area. In an interview with David Smoller, president, Sigma Aldrich, we find out more. Sigma’s division of regenerative medicine has been set up recently? Elaborate on the plans of the division? The regenerative medicine program within the research biotech division of Sigma-Aldrich was established in January, 2009. The mission of the regenerative medicine program is to provide a portal for the stem cell research community to access Sigma-Aldrich’s broad portfolio of life science products and services. Now these scientists have a single location to research and source the products they need to carry out their research. Further, the regenerative team will help to develop new products and services to overcome the limitations of existing products available to stem cell researchers. What are the new products launched by Sigma Aldrich for stem cell research? To date, the products launched by Sigma Aldrich include an expanded line of research antibodies useful for understanding genes that play a role in stem cell self-renewal and differentiation, and a new line of 3D scaffolds for growing stem cells in an environment that mimics in-vivo conditions. This year, the regenerative medicine group plans to launch many more cutting-edge products. Is this on the backdrop of the recent lifting of federal restriction on stem cell research? How is it going to impact the business of companies such as yours in the US? The impact from the lifting of federal restrictions is difficult to measure because privately financed stem cell research continues to play a significant role. We believe that the $10 billion of economic stimulus funding targeted at the NIH will have a significant impact in terms of stem cell research; this stimulus will increase available money for existing and new stem cell researchers to conduct more experiments. How do you see the stem cell research in India vis-a-vis the US? Since the creation of the task force on “Stem Cell Biology and Regenerative Medicine” in 2003, and the opening of the Manipal Institute of Regenerative Medicine in 2007, India has shown great interest and capability in advancing the science of stem cell biology, not only in basic research but also in the development of potentially lifesaving therapies. For research in any country the key issues are the availability of funding and the availability of a talented pool of scientists, and on both these counts we believe India is primed to lead. How do you view competition from other players in this segment and how do you differentiate yourself? Our competition also sees the opportunity in providing life sciences tools to stem cell scientists. It is our opinion that Sigma Aldrich’s efforts at developing new research tools along with our competitors will only benefit stem cell researchers. In this competitive market, we will differentiate ourselves by providing new technologies that address the limitations our customers face today, and by providing streamlined access to our products so that researchers can easily find what they need. What is the marketing strategy for the products? How much revenues do you hope to generate and how much are they going to contribute to the company’s gross revenue? We don’t typically comment on revenue projections within Sigma Aldrich divisions. However, we do expect this research market to grow at double digit rates year over year. Our strategy consists of several elements like aggressive launch of new products, expanding technical resources available to our customers, strengthening our presence in the stem cell research community, and continue to collaborate with leading stem cell research institutions in India and other nations. What are the future plans of the research biotech division of Sigma Aldrich? The research biotech division of Sigma Aldrich will continue to invest in capital and people to ensure our service to this and other growing markets. Further, as we always have done, we will acquire the necessary technologies and product content to address the future needs of our customers.  Stem cell lines The portal’s expanding line of cutting-edge technologies for stem cell research includes the industry’s most highly-validated shRNA library, the Mission RNAi portfolio, which enables gene silencing across a wide range of cellular targets. The site also features the CompoZr zinc finger nuclease (ZFN) reagent platform which enables researchers, for the first time, to target and precisely manipulate the genome of both differentiated cells and stem cells, resulting in cell lines or whole organisms with permanent, targeted gene deletions, insertions, or corrections. A complete line of polyclonal and monoclonal antibodies is available, including the Prestige Antibodies collection, considered the industry’s most highly characterized line of antibodies. Stemline animal serum-free media, essential for many researchers in the expansion and maturation of cell lines, is also available. Shalini Gupta ]]> <![CDATA[â€œPersistent Systems provides custom solutions for life sciences industriesâ€?]]> https://biospectrumindia.com/news/95/2032/persistent-systems-provides-custom-solutions-for-life-sciences-industries.html https://biospectrumindia.com/news/95/2032/persistent-systems-provides-custom-solutions-for-life-sciences-industries.html Wed, 08 Apr 2009 11:34:00 +0530 “Persistent Systems provides custom solutions for life sciences industries” —Dr Armaity Davierwala, senior life science domain consultant, Persistent Systems Armaity Davierwala has been associated with Pune-based Persistent Systems Limited since 2004 as a senior life science domain consultant helping with the domain aspect of various projects. In an exclusive interview with BioSpectrum Armaity shares her views about  Persistent’s life sciences business Tell us about Persistent’s life sciences business? The life sciences group at Persistent, has nearly a decade of experience and has effectively combined science and information technology to provide solutions for some of the top pharmaceutical, equipment and medical device vendors. In addition we also strongly work with academia: some of the leading universities and cancer centers.    Our life sciences business unit is one of the fastest growing verticals at Persistent, contributing to 10-15 percent of our revenue. We have over 400 people working on projects related to life science. Our team at Persistent includes 40 life science domain experts and several PhDs providing domain support to our several projects. What are your life sciences product offerings? Persistent Systems provides custom solutions for life sciences industries. We focus on four main domains viz. bioinformatics, clinical informatics, medical devices and instrumentation, and lab automation. We have expertise in 21 CFR Part 11 and HIPAA, since these are of extreme importance to the Pharma and healthcare industries. We also own a product called ChemLMS, which is a laboratory information management system (LIMS) that is deployed at several pharma companies worldwide. We are also doing a lot of work around cancer research. We are closely associated with the cancer biomedical informatics grid (caBIG) initiative from its inception. We are one of the leading providers of outsourced product development (OPD) services in the caBIG network, and have been named a caBIG support service provider by the National Cancer Institute (NCI). caBIG is a standards-based nationwide network that provides a grid infrastructure, data repositories, interoperable software and policy guidelines to enable data sharing and collaboration across the biomedical research community, with the goal of accelerating the realization of personalized medicine Is Persistent active in the LIMS space? If yes what are some of your products and technologies? Yes, Persistent is very active in the LIMS space. We also own a product called ChemLMS, which is a LIMS that is deployed at several pharma companies worldwide. In addition we also develop custom LIMS solutions, maintain and enhance industry-standard LIMS, customize LIMS for additional functionality, work flow and scalability; integrate LIMS with different laboratory instruments, data sources, and third party applications and provide support and training. Some of the LIMS Persistent has worked on include: Design and development of a custom LIMS for a public health laboratory for virology. Web-based LIMS for managing pre-clinical studies. Web-based LIMS for high-throughput labs like microarray, proteomics and flow cytometry. Design and development of a caBIGTM compatible biobanking system What are your plans for the year ahead? Will you be looking for partnerships in this space? The life sciences industry is seeing an increasing need to develop software tools to manage their data and analyze it quickly and meaningfully to increase their productivity and profitability.  The greatest concerns to the industry today, are escalating drug discovery costs and thinning drug pipelines. Developing software and predictive analytic tools for identifying lead compounds would enable the pharmaceutical industry to address this concern. Clinical trials are now being performed across multiple geographies and there is a need to manage this data and carry out predictive analytics on clinical trial performance management. Medical researchers face the challenge of integrating heterogeneous data generated by automated high-throughput technologies and correlating it with patient data to get meaningful information and enable personalized medicine. This approach, called “bench to bedside”, is becoming increasingly popular. Jahanara Parveen ]]> <![CDATA[â€œQuadrupole LCMS will continue to see robust demands in futureâ€?]]> https://biospectrumindia.com/news/95/2286/quadrupole-lcms-will-continue-to-see-robust-demands-in-future.html https://biospectrumindia.com/news/95/2286/quadrupole-lcms-will-continue-to-see-robust-demands-in-future.html Wed, 08 Apr 2009 11:31:00 +0530 “Quadrupole LCMS will continue to see robust demands in future” —Senya Imamichi, managing director, Shimadzu Analytical (India) Pvt Ltd Not long ago Shimadzu pioneered the introduction of Photodiode array detectors which went on to replace the conventional UV-VIS detectors in HPLC. The launch of LCMS-2020 in 2009 by Shimadzu heralds a new era in desk top Mass Spectrometric Detectors for HPLC systems that have the capability to address the most demanding requirements in pharmaceutical and life sciences. The development of LCMS 2020 is based on Shimadzu’s proven Mass Spectrom etry platforms which adopted simple, easy-to-use design while maintaining superior performance. Delivering the ultimate in measurement speed and sensitivity, the compact LCMS-2020 mass spectrometer offers faster measurements and higher detection sensitivity for quicker and more accurate analysis of trace impurities, environmental pollutants, and contaminants in different sample matrices. When combined with a Prominence ultra-fast LC (UFLC/UFLCXR) the system helps analysts achieve the ultimate in separation performance and productivity. The single quadrupole system of LCMS-2020 uses a patented ultrafast(UF) technology providing significantly higher sensitivity than any other single quadrupole analyzer and offers unique cost effective solutions to a range of analytical requirements such as mass identification, process monitoring, mass based purification etc. The new UFscanning technology achieves measurement speeds of 15,000 u/sec without sacrificing sensitivity or resolution, thus obtaining the best chromatography for the fastest LC conditions. UFSwitching technology of LCMS-2020 enables switching between positive and negative ion modes in 15 milliseconds so even the fastest LC peaks can be analysed in both modes, thus increasing productivity. Innovative ion optics with the newly developed Qarray ion optical system provide superior sensitivity, repeatability, and linearity, achieving 50 percent to 300 percent greater sensitivity than any other single quadrupole analyzer for substances most commonly measured. Users can inject less and keep the analyzer cleaner, longer. LCMS-2020 enables improved high mass operation with sensitivity increased by more than 500 percent for masses above 1,000. In addition to better performance, the LCMS-2020 allows easier maintenance, permitting users to replace the ionization unit and inlet capillary to the MS from the LC, without breaking the vacuum. The ESI method typically used for LCMS can be replaced with APCI, which is suitable for neutral compounds, or with a dual ionization source (DUIS) for simultaneous operation of both ionization modes, quickly and without tools. The new Shimadzu LCMS-2020 with its breakthrough technology is the world’s most sensitive, fastest scanning and fastest polarity switching single quadrupole mass spectrometric detector available. The launch of LCMS-2020 recently at Delhi attracted a large number of Mass Spectroscopists from the Pharmaceutical Industry. The strength of single quadrupole mass spectrometric detectors lies not only in their adoption by HPLC users but also by the pharmaceutical industry as a whole. Applications on DMPK (Drug Metabolism and Pharmacokinetics) and compound screening are particularly well suited for single quadrupole LCMS. Besides its high resolution and accuracy, LCMS is also a high-throughput technique capable of meeting a number of pharmaceutical industry’s needs from R&D from analytical services, to method development and quality control. With increases in Pharmaceutical R&D spending and advancements in drug development, single quadrupole LCMS will continue to see robust demands in future. ]]> <![CDATA[â€œWe have nine new products to be launched in 2010â€?]]> https://biospectrumindia.com/news/95/2833/we-have-nine-new-products-to-be-launched-in-2010.html https://biospectrumindia.com/news/95/2833/we-have-nine-new-products-to-be-launched-in-2010.html Wed, 08 Apr 2009 11:16:00 +0530 “We have nine new products to be launched in 2010” —Hemant K Gupta, president, Axygen Scientific Founded and incorporated in 1993, Axygen Scientific is one of the leading global suppliers of laboratory plastics for the research industry, including the pharmaceutical, biotech, and academia markets. Axygen is headquartered in Union City, California. In an interview with  Hemant K Gupta, president, Axygen Scientific, we find out more about the company’s future plans. What have  been the company’s revenues for the year 2008-2009? What percentage of these are derived from the Asia Pacific region? We registered consolidated revenues of  $110 million in  2008, including the  80 countries that Axygen operates in. Approximately 5.2 percent of our revenues are derived from the Asia Pacific region. We have been meeting our targets every year and this year also we expect similar performance. Some of the growth drivers of Axygen are the constant introduction of new products, penetration of international markets and strategic acquisitions. How has Axygen addressed the needs of the life sciences market since its inception? For Axygen product improvement does not stop with a one-time change. It’s a continuous process driven by our desire to help scientists to get consistent results faster and easier. Our R&D, engineering and marketing teams work closely with customers to continuously update our products and introduce novel designs. What are the different segments that the company operates in and what are the revenue grossing products for Axygen over the last year? High throughput screening (HTS), PCR and reagents are some of the segments we operate in. We enjoy a market share of 60 percent in the HTS segment in India. High throughput screening products have been the biggest revenue driver for Axygen over the last year. Recently we have entered into the nucleic acid purification market with a wide range of kits and reagents. What are the major collaborations of Axygen over the last year and how those collaborations influenced the business? We have a number of important collaborations with the academia and industry. We have become a leader in our market by strategic acquisitions of other companies. Including the  recently  acquired Sorenson Biosciences (2008), a global leader in innovative consumables and lab-ware. What are the emerging markets for Axygen and how are you trying to increase the business in those markets? China, India and Singapore are some of the emerging markets for Axygen. Our field staffs are working closely with our distribution partners to identify opportunities and close them in a timely fashion. We have also organized training programs and sales meetings to bring our distributors closer to us and penetrate the market. What do you think is the strength of the company? We believe our strength is in our field personnel who work with our customers. We also have a strong marketing team in all the countries that we operate in. We believe we are a customer-friendly company that involves the scientist in building up our product range. Besides, we can design and manufacture consumable products and kits from any of our worldwide locations. What are the trends that you see  in technology worldwide? Customers are looking for the freedom to choose their robotic system and have consumables to work with the system of their choice. Customers don’t want to be locked in with a single company for instruments and consumables which limits their choices. We offer consumables that work on a number of market leading platforms and give customers the power to choose. Customers are also looking for the best value for their money and Axygen can deliver this for the customers. What are the products to be launched next year? Two technologies that we plan to launch in the coming year are RNA and micro RNA isolation kits for RNAi and stem cell research and novel reagents like X-Gal/IPTG spray and Smart Ampicillin. This year, we plan to launch cell and tissue culture lab-ware. In the first half of the year we plan to launch protein kits and protein matrix in the Indian market. We have nine new products to be launched in 2010 in the area of HTS, five new products in the reagents segment. We also aim to go a notch up and register a 10 percent increase in revenues in the next financial year through our product range. Shalini Gupta ]]> <![CDATA[â€œThere is a need to store more stem cellsâ€?]]> https://biospectrumindia.com/news/95/2180/there-is-a-need-to-store-more-stem-cells.html https://biospectrumindia.com/news/95/2180/there-is-a-need-to-store-more-stem-cells.html Wed, 08 Apr 2009 11:05:00 +0530 “There is a need to store more stem cells” —Colin Mc Guckin, scientific director, Cryo-Save Group Stem cells have for long been a subject of controversy but at the same time have generated  curiosity among scientists who have patiently been working on stem cells for all these years to find remedies for life-threatening diseases. With the recent lifting of the ban on stem cell research by President Barack Obama, stem cell research is expected to get a new fillip in the form of federal funding. We talk about this and more with Prof. Colin Mc Guckin, president and co-founder of Novus Sanguis Consortium, which brings together leading adult stem cell researchers  to work on treatment of human diseases. Prof. McGuckin has 20 years of experience in stem cell research and tissue bioengineering and was recently appointed as the scientific director of Cryo-Save Group. In your research career spanning 20 years, what have been some of the advances in stem cell research worldwide? Twenty years ago, only a handful of diseases were being treated with umbilical cord blood stem cells. Today, over 80 diseases are treatable or supportable; the advances that have been made are staggering, after achieving this we have to take stem cell banking very seriously. It is now possible to store cord blood stem cells for many years, which can then potentially be used again to treat the individual’s or their sibling’s life. Tissues taken from it can be used to grow a number of organs and repair damaged ones. Though research is still in its infancy, the future is really bright. I am proud and excited to be working in a field of medicine that can contribute to the health of our children. How do you see the controversy surrounding human embryonic stem cell research? Embryonic stem cell research is getting lot of hype in the media. The stem cell research using cord blood cells is more realistic and is likely to benefit patients. Of course, stem cells are not the whole answer for future medicine. There are some diseases that cannot be cured by treatments, so we always recommend patients to pay strict attention to the advice of the doctor. How can stem cells help drug discovery and cut costs? New drugs can be tested in test tubes itself and not on animals and later, on  humans. After all, we are different from animals and what may work on lab rats may not work on human beings. Also, there is a certain danger involved in using human volunteers. Mini-livers or any other organ grown this way, using stem cells, can be used by pharmaceutical companies to test new drugs and help contribute to human medicine. How will healthy regulatory environment, funding and public private partnerships enhance stem cell research? Public-private partnership is the key; it has been clearly demonstrated that tissues taken from cord blood and the cords themselves have immediate uses to benefit a large number of people. We are happy to work with the Indian government to help advance this. Indian government shows willingness to help develop a framework for stem cells, but of course the work of any government is complex and we cannot expect these things to happen overnight. For that reason, I believe that we have to look at private companies to help us with stem cell banking to ensure the health of our children. We have to get new therapies and we must work with the government to make sure that no patient is treated in the wrong way, or with a treatment that is not safe. This is very important! How will the lifting of federal restrictions on stem cell research in the US boost the research activities? The development in stem cells research in the US will help other governments across the globe to move in the same direction. I am not confident on embryonic research as it will create a tissue line matching to the host.  We have to wait and see. Stem cell research and cord blood based stem cell therapy is still nascent in India. How will India cope with this? India has a long history of medical innovation and a willingness to look at new ideas. The stem cell treatment will bring more benefits to India, which has high birth rates and huge population. Many people in India have not stored their stem cells, not in public banks or in private stem cell banks, and this affects the development in stem cell therapy. I came to India to highlight this and help to make people aware of what they could be achieving. Cryo-Save’s  objective is to bring all the researches that are happening in our labs in EU to reach the common man in India quickly. Our lab in Bangalore is GMP certified. Although the Indian government does not require this yet, other governments do, and Cryo-Save felt it was important not to cut corners, but to do it correctly and well. We want to bring in therapies to India from our research labs without much delay. We also planning to give training to doctors in India. How do you see the future of stem cell research? Stem cells may not cure everything because proper medication and hospitalization is equally important. There is a need to store stem cells, because if we don’t have stem cells in the banks, then many people will not benefit from the new treatments. In Type I diabetes, children between 7-10 years of age are affected. The attacks are in the pancreas and the affected children cannot produce insulin properly. For such children, cord blood is directly infused into the circulatory system and it helps against the damage in the pancreas. But this treatment facility is not available across the world and it stress the need to store the cord blood in the first place. After spending years researching regenerative and tissue engineering, I have realized that there is still a  need to do a lot more. There is a need to store more stem cells. Germany has stored more cord blood than India; the population in Germany is much lesser than India. Now, we have the ability to store many human tissues, such as the umbilical cord itself, and in the future, possibly other human tissues. In future, stem cells will play a crucial role in treatment. So, I dream of a day when we will have cord blood banks in every major city in the world to help protect the health of our people. Let’s hope that this will happen in India. Shalini Gupta ]]> <![CDATA[Rethinking recession in the positive light]]> https://biospectrumindia.com/news/95/7288/rethinking-recession-in-the-positive-light.html https://biospectrumindia.com/news/95/7288/rethinking-recession-in-the-positive-light.html Wed, 08 Apr 2009 11:01:00 +0530 Rethinking recession in the positive light The power-packed conference jointly organized by held by the Federation of Indian Chambers of Commerce and Industry (FICCI)  and the Department of Pharmaceuticals lucidly illustrated  the world of opportunities  the recession can offer to life sciences companies. The summit entitled, “Pharmaceuticals 2014: Will India Leap Forward” was held in Mumbai. The summit was organized by FICCI with Department of Pharmaceuticals, Ministry of Chemicals and  Fertilizers, Government of India and Observer Research Foundation (ORF). Cash reserves and liquidity might be at an all time low, valuations of start-ups especially small and medium size biotech companies might have shown a nosedive drop, so what? asserted experts from different spheres of the industry present at the summit. Here goes the brownie points for the industry. While market pundits associate recession with a freeze in investments, sitting tight on cash reserves all amalgamating to the consolidation of the life sciences industry,  speakers  on the contrary retorted otherwise. Perhaps life sciences should take a leaf out of Ratan Tata’s bold business decision in taking the plunge to launch the much awaited ‘Nano’ into the Indian market! If automobile companies, which was most hit by the turmoil, can do it, so can life sciences companies. Glenn Saldanha, managing director and CEO, Glenmark Pharmaceuticals Ltd and chairman of National Pharmaceuticals Committee, FICCI, observed that the pharmaceutical sector will be less impacted by the economic slowdown, although, it will see cost containment and its impact on R&D projects. Also, with the pipeline for new products drying up, there would be consolidations in the industry. Dr Dhankar, partner, Mckinsey and Co, New Jersey,  gave a thought-provoking analysis. Life Sciences as an industry  is outside recession’s vicious cycle hence the answer to the  most debated question of “how long will the recession last and whether it is short lived?” is plain and simple – ‘It doesnt matter!’The contention being, companies develop better strategies during times of uncertainty. With cash reserves drying up, conventional business strategies adopted by companies would be to sit tight fisted with all the cash that they have for the next 24 months, as is the basic prediction about the period of recession, but Mckinsey’s suggestion  to companies was to spend as much as they could during this period.  “From the past recessions it was observed that companies which emerged stronger after a recession were the ones that followed countercyclical patterns of utilization and spending. Average sized companies that had less cash in hand but decided to spend and invest heavily were the ones which emerged stronger,” told Dr Dhankar exclusively to BioSpectrum.  There have been companies like El Lilly, Novartis, Bristol Myers Squibb, JohnThe summit entitled, “Pharmaceuticals 2014: Will India Leap Forward” was held in Mumbai. The summit was organized by FICCI with Department of Pharmaceuticals, Ministry of Chemicals and  Fertilizers, Government of India and Observer Research Foundation (ORF). Cash reserves and liquidity might be at an all time low, valuations of start-ups especially small and medium size biotech companies might have shown a nosedive drop, so what? asserted experts from different spheres of the industry present at the summit. Here goes the brownie points for the industry. While market pundits associate recession with a freeze in investments, sitting tight on cash reserves all amalgamating to the consolidation of the life sciences industry,  speakers  on the contrary retorted otherwise. Perhaps life sciences should take a leaf out of Ratan Tata’s bold business decision in taking the plunge to launch the much awaited ‘Nano’ into the Indian market! If automobile companies, which was most hit by the turmoil, can do it, so can life sciences companies. Glenn Saldanha, managing director and CEO, Glenmark Pharmaceuticals Ltd and chairman of National Pharmaceuticals Committee, FICCI, observed that the pharmaceutical sector will be less impacted by the economic slowdown, although, it will see cost containment and its impact on R&D projects. Also, with the pipeline for new products drying up, there would be consolidations in the industry. Dr Dhankar, partner, Mckinsey and Co, New Jersey,  gave a thought-provoking analysis. Life Sciences as an industry  is outside recession’s vicious cycle hence the answer to the  most debated question of “how long will the recession last and whether it is short lived?” is plain and simple – ‘It doesnt matter!’The contention being, companies develop better strategies during times of uncertainty. With cash reserves drying up, conventional business strategies adopted by companies would be to sit tight fisted with all the cash that they have for the next 24 months, as is the basic prediction about the period of recession, but Mckinsey’s suggestion  to companies was to spend as much as they could during this period.  “From the past recessions it was observed that companies which emerged stronger after a recession were the ones that followed countercyclical patterns of utilization and spending. Average sized companies that had less cash in hand but decided to spend and invest heavily were the ones which emerged stronger,” told Dr Dhankar exclusively to BioSpectrum.  There have been companies like El Lilly, Novartis, Bristol Myers Squibb, Johnson and Johnson, which have taken ‘bold actions’ even in this period of uncertainty.  Though it has been glottalization of investments which has aggravated the intensity of the situation, globalization alone is the answer to reduction of costs and hiking up of innovation. With buyouts and acquisitions being the latest mantra for global companies, the assumption that Indian companies are ripe for being acquired holds no water in this period of credit crunch though the possibility cannot be ruled out totally. On the other hand, this is the conducive time for Indian companies being aggressive and buying out companies, biotech in particular, in the US. What will the economy look like during and post recession?  McKinsey presents four diverse scenarios that the economy might land up, though the outcomes are hard to predict. Scenario one is a situation where the global credit and capital markets open up, this will see a  regeneration of global momentum which is moderate recession spanning over 3-4 quarters followed by strong growth and changes in the regulatory regimes.  Scenario two is a situation where the global credit and capital markets reopen and recover but  is coupled with severe global recession. This will see an economy which is battered but resilient marked with a  prolonged recession of 2-4 years with recovery led by effective fiscal, monetary and  regulatory policies. Scenario three is a situation which is an amalgamation of moderate recession with global credit and capital markets being volatile and closed down. This will see a ‘stalled globalization’  with a moderate recession for 1-2 years followed by slow economic growth and significant government involvement in bringing about credit allocation and regulatory changes. Lastly, Scenario four consists of two extreme factors, severe global recession coupled with global credit and capital markets which are volatile and not opening up. This will lead to a scenario of a so called ‘long freeze’ where we see a recession for over five years, stagnation and regulatory irregularities, and ineffective monetary and fiscal policies  Graham Lewis, vice president-Europe, IMS Health UK, gave another angle to the solution. “A recession like this adds urgency to the situation and as a result companies start rethinking their strategies and sort out issues.  This is where there will be a rise of the ‘pharmerging markets’ which will see a double digit growth.”  The US might show a flat  growth but  reality for all companies is that the US is still the dominant market having 40 percent of global shares.  So companies need to be in the US despite its almost stagnant growth.  However for companies aspiring rapid growth, ‘pharmerging markets’ which will show a strong double digit growth, is the right place to be. Sameer Savkur, managing director, ORG IMS Research Pvt. Ltd, gave the India perspective, “ True, recessions like this does impact all stakeholders in the value chain which includes patients, manufacturer, distributors, healthcare providers and payers. Growth might be impacted but in the process companies should not exit commercial areas where there are growth opportunities.”  IMS was optimistic and stated that recovery was a possibility in 2009 itself with a growth of 14 percent despite the recession. In terms of approaches companies need to revise their business strategies, rethink their R&D strategies, look at their product portfolios, even look at hospitals and rural areas and make their sales forces more effective.  The instant reaction might be everything is easier said than done. There are issues and obstacles like regulatory issues, talent and infrastructure hurdles, but the key now is the  government intervention. The US, Canada, Singapore and China governments are taking  proactive roles as far as investments are concerned.  The Chinese government has invested around $1.5 billion while the Singapore government is invested $1.2 billion. Neighboring country and rival China is focusing on surging up academic institutions, incentives for overseas talent to return, tax exemptions and to start five bioscience parks. The Government of India too  has decided to take the step and push the envelope forward. Ashok Kumar, secretary of Department of Pharmaceuticals, which has been recently set up by the Government of India, shared the proposed initiatives for making India as one of the top five global pharmaceutical innovation hub by 2020. He mentioned that the economic and social returns of the proposal are estimated to create 5 lakh high end jobs for scientists and specialist, and also provide the country with low cost healthcare for chronic and life threatening ailments including some of the neglected diseases. As a part of this effort, the government will deliberate action on four fronts – infrastructure and manpower, PPP, financial incentives and models as well as a favorable regulatory model for drug or molecule discovery. It is estimated that the annual expense towards achieving the aspirational innovation hub status would be as much as $2 billion, for which a substantial public private partnership would be required. “The global economic slowdown presents an opportunity for the Indian industry to work on low cost medicines, one of the key strengths that we have,”  Ashok Kumar added. FICCI then organized a closed door discussion with prominent industry persons on “Drug Discovery – A Business Opportunity” in order to critically analyze the opportunity and the short comings to work out a detailed plan to accomplish stated roles of the government, industry and associations. FICCI will prepare a report and action plan for implementation and will work closely with the government and industry to help achieve the proposed vision 2020 for the pharmaceutical sector.  n Nayantara Somson and Johnson, which have taken ‘bold actions’ even in this period of uncertainty.  Though it has been glottalization of investments which has aggravated the intensity of the situation, globalization alone is the answer to reduction of costs and hiking up of innovation. With buyouts and acquisitions being the latest mantra for global companies, the assumption that Indian companies are ripe for being acquired holds no water in this period of credit crunch though the possibility cannot be ruled out totally. On the other hand, this is the conducive time for Indian companies being aggressive and buying out companies, biotech in particular, in the US. What will the economy look like during and post recession?  McKinsey presents four diverse scenarios that the economy might land up, though the outcomes are hard to predict. Scenario one is a situation where the global credit and capital markets open up, this will see a  regeneration of global momentum which is moderate recession spanning over 3-4 quarters followed by strong growth and changes in the regulatory regimes.  Scenario two is a situation where the global credit and capital markets reopen and recover but  is coupled with severe global recession. This will see an economy which is battered but resilient marked with a  prolonged recession of 2-4 years with recovery led by effective fiscal, monetary and  regulatory policies. Scenario three is a situation which is an amalgamation of moderate recession with global credit and capital markets being volatile and closed down. This will see a ‘stalled globalization’  with a moderate recession for 1-2 years followed by slow economic growth and significant government involvement in bringing about credit allocation and regulatory changes. Lastly, Scenario four consists of two extreme factors, severe global recession coupled with global credit and capital markets which are volatile and not opening up. This will lead to a scenario of a so called ‘long freeze’ where we see a recession for over five years, stagnation and regulatory irregularities, and ineffective monetary and fiscal policies  Graham Lewis, vice president-Europe, IMS Health UK, gave another angle to the solution. “A recession like this adds urgency to the situation and as a result companies start rethinking their strategies and sort out issues.  This is where there will be a rise of the ‘pharmerging markets’ which will see a double digit growth.”  The US might show a flat  growth but  reality for all companies is that the US is still the dominant market having 40 percent of global shares.  So companies need to be in the US despite its almost stagnant growth.  However for companies aspiring rapid growth, ‘pharmerging markets’ which will show a strong double digit growth, is the right place to be. Sameer Savkur, managing director, ORG IMS Research Pvt. Ltd, gave the India perspective, “ True, recessions like this does impact all stakeholders in the value chain which includes patients, manufacturer, distributors, healthcare providers and payers. Growth might be impacted but in the process companies should not exit commercial areas where there are growth opportunities.”  IMS was optimistic and stated that recovery was a possibility in 2009 itself with a growth of 14 percent despite the recession. In terms of approaches companies need to revise their business strategies, rethink their R&D strategies, look at their product portfolios, even look at hospitals and rural areas and make their sales forces more effective.  The instant reaction might be everything is easier said than done. There are issues and obstacles like regulatory issues, talent and infrastructure hurdles, but the key now is the  government intervention. The US, Canada, Singapore and China governments are taking  proactive roles as far as investments are concerned.  The Chinese government has invested around $1.5 billion while the Singapore government is invested $1.2 billion. Neighboring country and rival China is focusing on surging up academic institutions, incentives for overseas talent to return, tax exemptions and to start five bioscience parks. The Government of India too  has decided to take the step and push the envelope forward. Ashok Kumar, secretary of Department of Pharmaceuticals, which has been recently set up by the Government of India, shared the proposed initiatives for making India as one of the top five global pharmaceutical innovation hub by 2020. He mentioned that the economic and social returns of the proposal are estimated to create 5 lakh high end jobs for scientists and specialist, and also provide the country with low cost healthcare for chronic and life threatening ailments including some of the neglected diseases. As a part of this effort, the government will deliberate action on four fronts – infrastructure and manpower, PPP, financial incentives and models as well as a favorable regulatory model for drug or molecule discovery. It is estimated that the annual expense towards achieving the aspirational innovation hub status would be as much as $2 billion, for which a substantial public private partnership would be required. “The global economic slowdown presents an opportunity for the Indian industry to work on low cost medicines, one of the key strengths that we have,”  Ashok Kumar added. FICCI then organized a closed door discussion with prominent industry persons on “Drug Discovery – A Business Opportunity” in order to critically analyze the opportunity and the short comings to work out a detailed plan to accomplish stated roles of the government, industry and associations. FICCI will prepare a report and action plan for implementation and will work closely with the government and industry to help achieve the proposed vision 2020 for the pharmaceutical sector.  Nayantara Som ]]> <![CDATA[Big pharma on biotech acquisition spree]]> https://biospectrumindia.com/news/95/1970/big-pharma-on-biotech-acquisition-spree.html https://biospectrumindia.com/news/95/1970/big-pharma-on-biotech-acquisition-spree.html Wed, 08 Apr 2009 10:50:00 +0530 Big pharma on biotech acquisition spree Pharma giants have finally come to realize that acquisition of biotech companies is their last hope with patents expiring and R&D pipelines drying up. Multi-billion dollar deals is something pharma and biotech companies should get  used to by now.  The life sciences industry had in March, 2009, completed its hat trick with, Roche and Genentech ending their long drawn ‘hostile war’, by entering into a mutual agreement, with the former buying out  the latter for $46.8 billion at $95  per share. What is all the more exciting is analysts predicting that a spate of similar deals will follow suit in the current year. These acquisitions has but gone  much against market soothsayers advice on shutting out options of large scale investments (mainly M&As) during a period of prolonged recession. “The industry is going through a transition, and such deals were bound to happen to prevent the death of the big pharma, be it recession or no recession,” confided a reliable industry analysts under the condition of anonymity.  Earlier in the beginning of the year, we had seen big pharma, Pfizer, buying over Wyeth for $68 billion, the fourth largest acquisition in the pharmaceutical industry. This was followed by another US-based giant, Merck, closing its $41 billion dollar deal to acquire Schering Plough. A marriage between the pharmaceutical and biotech companies has suddenly become a reality and  it is accelerating at a breakneck speed. Cash is king An acquisition was a  much more attractive proposition for these bigwigs than an alliance or licensing deals.  Much has been debated about “why an M&A?” but the million dollar question now cropping up is  how could all these deals, coming to a total of $163 billion, have come about with the stock markets reaching a rock bottom, cash credit loans drying up and above all banks declaring bankruptcy. Firstly, it is but a myth that banks and financial institutions are reluctant to lend money for such deals . The more appropriate answer would be that they are looking out for the right deal. “Banks do have their reservations but at the same time it is not that they will sit tight on all their cash. They are just looking out for the right deals. And big pharma has that cash available,” informed a reliable expert. “Big pharma can afford to go ahead with such mighty deals. They have their own cash reserves and then we have stocks.  For the Pfizer- Wyeth deal, banks alone provided around $22 billion. Big pharma companies make good and reliable borrowers. Banks are looking not just at right deals but also at better profiles,” opined  Sujay Shetty Attribute  it to the notion that this is the right time for large scale M&As. Experts unanimously point out that the ideal mantra at this time would be “To Take the bold step”. At a Federation of Indian Chambers of Commerce and Industry (FICCI) meet held in Mumbai recently, Dr Ajay Dhankar from Mckinsey and Co, New Jersey, said, “Recession is the ripe time for growth opportunities. The ideal business strategy for these companies would be to spend as much as possible and invest in different baskets. It has been observed that it is these companies which emerge out as winners after the recession.” “This is the ideal time for buyouts because valuations for biotech companies are at an all time low so this is the ripe time for pharma companies acquiring them,” commented the global CEO of the one of the top CMO companies in the world. “The news is that in total banks provided a total of $30 billion for these deals. Moreover these banks have been bailed out by the federal government and hence they are being provided the requisite cash amount,” added Majumdar. The Pfizer-Wyeth  acquisition deal was financed through cash, debt and stocks with banks giving out cash amounting to $22.5 billion. The Roche-Genentech deal which was sealed at $46.8 billion out of which $40  billion will be said to be raised through bonds.  The  Merck Schering-Plough buyout on the other hand will be financed with a combination of $9.8 billion from existing reserves and $8.5 billion from committed financing from JP Morgan Chase & Co. The symbiotic relationship With the lurking fear among  big-wigs as their revenues taking a nose dive dip  due to  drying up of R&D pipelines and patent expiration of blockbuster drugs, these deals will definitely be the answer to their prayers. While commenting on the acquisition trend Sujay Shetty, associate director, Financial Advisory Services Pharma/LifeSciences, Pricewaterhouse Coopers Pvt Ltd said, “These  acquisitions will strengthen the pipeline of the pharma companies and prevent their revenues from falling. Like for Merck, it will also give them access to the emerging markets.  These deals will also help in a lot of cost reductions. Tapping of emerging markets comes more in their long term strategy. It has been estimated that by 2012 when patents expire, revenue losses may amount up to $130 billion.”  The environment now is such that on one hand we have big pharma companies sitting on lots of cash, their  account books showing minimal margins of cash debt, which on a average is just around six percent, but they are on the verge of collapse with drying up pipelines and patents of their blockbuster products; while on the other hand we have biotech companies, having a slew of innovative products in their pipeline, which are slated to be the next ‘big thing’ yet reeling under a credit crunch during the prolonged period of recession. There is a strategic similarity to all these deals. “The purpose of all the three deals is cost cutting; for each of the deal, both companies have targets which fit into each other’s business models.  They are complimentary to each other. Its more of the US and European companies coming together,” said Supratim Majumdar, industry analyst, South Asia and Middle East, Healthcare, Frost & Sullivan. Take Merck- Schering Plough deal for instance, both the companies  have overlapping portfolios  for cardiovascular, respiratory and anti-viral drugs, and experimental drugs. Schering-Plough will add animal health products and a consumer division to Merck’s profile, while bolstering its women’s health area, led by Merck’s cervical cancer vaccine, Gardasil. The companies already had an agreement with their cholesterol treatment, Vytorin, a combination of Schering-Plough’s Zetia and Merck’s generic drug Zocor. Moreover Schering-Plough has drugs in late-stage testing that may top $6 billion in annual sales, and already has a partnership with Merck to split sales of the Zetia and Vytorin cholesterol pills, which generated $4.6 billion last year. A Pfizer-Wyeth conglomerate will bring about a 50 percent increase in total revenues. Nandakishore K, industry manager, Health care Practice, Frost and Sullivan had earlier told BioSpectrum when the deal was just announced, “Pfizer’s dependency on one drug is huge. A merger will bring about a consolidation in their market position not just in the purely pharmaceutical space but in diversified areas like vaccines, animal health and biologicals.”  “Wyeth’s product portfolio includes the more non-traditional areas of pharmaceuticals which in a way compliments with that of Pfizer, which focus on niche areas like oncology and antibiotics. A nexus will give them a wider base,” said Ajit Mahadevan, partner, Advisory Services, Ernst and Young. About 12 percent of Wyeth’s revenues comes from consumer healthcare, five percent from animal health and 36 percent from biologics. At present, Pfizer has a product pipeline which includes clinical trials for Sutent (oncology) 10 phase-I programs whose mechanisms have not yet been designed. In the same therapeutic segment, Wyeth’s products include clinical trials like Posutinib (for diseases like breast cancer) and Inotuzumab. Pfizer has two phase-II and one Phase-I trial in Alzheimer while Wyeth has five phase-I programs in this segment. In a joint statement given by both the parties it was specified, “This combination means a broad portfolio of health care solutions and treatments for every stage of life:leadership positions in key therapeutic areas such as cardiovascular, oncology, women’s health, CNS and infectious disease; in vaccines, biologics and small molecules; and in animal health, with products for companion animals, biologics and anti-infectives. A robust pipeline of biopharmaceutical development projects include  programs in inflammation/immunology, oncology and pain, as well as a significant opportunity to find a cure for Alzheimer’s disease.” The Roche-Genentech deal,  is more a synergy of capabilities and expertise. The combined company will be the seventh largest pharmaceuticals company in the US in terms of market share. It will generate approximately $17 billion in annual revenues and will employ around 17,500 employees in the US pharmaceuticals business alone, including a combined sales force of approximately 3,000 people. Genentech’s  anti-cancer drug as well as best selling product, Avastin, will be something both parties will be pinning their hopes on. The study data expected to be released in April, 2009, on the effectiveness of Genentech’s Avastin in treating early-stage colon cancer. The drug is already approved for various types of breast, lung and colon cancers. Research and early development will operate as an independent center within Roche from its existing campus in South San Francisco, retaining its talent and approach to discovering and progressing new molecules. Roche’s Pharma commercial operations in the US will be moved from Nutley, New Jersey to Genentech’s site in South San Francisco. The combined company’s US commercial operations in pharmaceuticals will operate under the Genentech name, leveraging the strong brand value of Genentech in the US market.  Roche has already begun to wind down operations at its Palo Alto facility and will relocate the site’s virology research and development activities to South San Francisco. Roche’s Palo Alto Inflammation group is in the process of becoming part of Roche’s Nutley research and development organization. Genentech’s late stage development and manufacturing operations will be combined with the global operations of Roche, achieving substantial scale benefits, operational synergies and cost avoidance. Roche’s manufacturing operations in Nutley will be closed and support functions, such as informatics and finance, will be consolidated with those of Genentech. The darker side The bad news is  that the mergers and acquisitions might blunt the incentive for innovation for biotech companies which have been swallowed by their pharma partners. There have been fears that these pharma giants  may bring a stopgap to research of  some innovative products which biotech companies have been working upon. The much feared about change which might come about is layoffs which was already initiated and declared during the Pfizer-Wyeth deal. When the Pfizer-Wyeth deal was announced there were rumors doing the rounds of a possible 20,000 cuts in jobs globally, out of which 8,000 would be researchers.  Merck has already declared that it would cut jobs by 16,000 along with operating costs to improve their bottom lines. After the deal was closed Roche-Genentech came up with a press release which stated, “Synergies will be largely driven by reducing complexity and eliminating duplicative functions and processes in areas like late stage development, manufacturing, corporate administration and support functions. Savings resulting from this combination will enable the new company to increase and better focus its investment in innovation.” The Roche-Genentech deal will see job cuts amounting to almost 1,500 most of which will be from commercial operations, largely sales and marketing personnel. Skeptics also foresee that such mergers might slow down R&D activities. Their contention being that big R&D teams do not necessarily mean bright  future prospects of  blockbuster drugs. They opine that scientists operate better in comparatively small teams. In the past, we have also seen big pharma going into numerous other acquisitions with the same purpose of portfolio strengthening, spending billions of dollars on R&D alone, however  it failed to lead to an upsurge of products. “The R&D structure is different for pharma and biotech.  So to mathematically assume that innovative products will double with a merger of two R&D teams is incorrect. A lot depends on integration,” asserted Majumdar. However, Shetty gives a justification for his disagreement. “Pharma  companies were looking incremental innovation, higher productivity and strengthening of R&D. For this a much deeper impact was required. These acquisitions will help them achieve such targets. Plus this is the right time for such deals with valuations reaching historic lows and cost reduction pressures”. Who is next in the pipeline ? The three ‘blockbuster’ mergers will offset and probably build on the pressure for many other pharma companies to follow suit.  There are talks doing the rounds of Bristol Myers Squibb (BMS) going the same route. “Yes in fact before the Merck-Schering Plough deal, we had anticipated either Merck or BMS going in for a mega deal. So now with Merck having already acquired Schering Plough, we  are expecting BMS going into a similar deal,” said Shetty. “I do not think we will see more than two mega deals coming through this year or even towards early 2010. Out of which BMS is a likely  candidate for the next deal,” confirmed  Majumdar.  From the biotech side Amgen and Genezyme are some of the likely candidates to be acquired. Both these companies have their focus on niche areas, have products which are most likely to become blockbusters. Genezyme  for instance, has its focus on rare diseases, giving its products  less prone  to competition. Other attractive biotech companies include Biogene, Vertex and Amylin. The year 2009, is definitely a landmark in the history of the life sciences industry. But the message now is loud and clear-Biotech is the place to be!  Nayantara Som ]]> <![CDATA[â€œRisk appetite takes a beatingâ€?]]> https://biospectrumindia.com/news/95/1861/risk-appetite-takes-a-beating.html https://biospectrumindia.com/news/95/1861/risk-appetite-takes-a-beating.html Wed, 08 Apr 2009 10:42:00 +0530 “Risk appetite takes a beating” —Murali Nair, partner, Advisory Services, Ernst & Young In a freewheeling interview,  Murali Nair, partner, Advisory Services, Ernst & Young,  gives his views on the  scenario of venture capital funding in biotechnology in the backdrop of the current global economic turmoil. How has the recent financial turmoil affected the biotech industry in the last six months in terms of  venture capital (VC) funding? Globally, we have to view this recession from two aspects. One is from the traditional business model wherein the funding for biotech companies mostly comes from VCs and private equities (PEs). But, there are not many VC firms that will be able to take the risk of putting in funds for biotech ventures. As far as  risks are concerned, my personal opinion of the recession is that, it is more of an emotional decision.  It will not take much time for the  fundamentals to correct itself  but  it will take time for the sentiments to come back. Because at the end of the day, growth will not happen just because the fundamentals have corrected itself or somebody is giving credit loans.  Risk appetite is the key for any development. That takes a very big beating when you have a recession. In India, the extent of the recession is far more than the actual market reality and I do not think we are affected  except  a few sectors.  When you decide on investments you spread it across categories like low, medium and high risk,  where the  high  risk gets eliminated. Biotechnology was never a low or medium risk investment that is the challenge when biotech funding goes globally. If you look at the funding globally, it is mainly done by  the government or VCs (almost 60 percent). Now, even the government is  under tremendous strain as it is now looking at bringing in generic drugs and possible ways to cut health care costs. Funding, which is the oxygen for biotechnology, being an innovation-driven industry, will be a challenge if you look  at standalone biotech companies.  However, it is difficult in the case of pure biotechs diluting their place to pharma  companies. Big pharma  has no option but  to look at biotech if it wants  to fill up its pipeline. The entire innovation game will now be played very differently. The big pharma companies are sitting on tonnes of cash and do not have debt. The big biotech companies will get acquired while the small and medium companies will see a lot of alliance relationships. VC-based funding can take you up to a certain level but in order to get the benefit, commercialization of products which the biotech companies in the past have found it difficult to handle is important. It  will be a synergy of capabilities. Is innovation one of the reasons for VCs  in India to take a backseat? Innovation as a culture never existed in India  in a manner that  would have facilitated basic research. Our focus for basic research or rather innovative research  was very limited  for many years.  Even the  big pharma companies started investing in basic research only a few years back and biotech being a much smaller sibling than pharma naturally did not have place, ambition and aspiration to build basic research.       Globally, the difference between biotech and modern pharma is that biotech is far more fundamental  because it goes back to the genesis and synthetic pharma is less more complex and understood by a larger majority of people.  India’s biological capabilities are lesser than the chemistry capabilities and China is far ahead of India on biological capabilities.  The very nature of investment  is also tough because biotech addresses the very fundamentals of a subject and it is a new topic.  But any thing that is radical will take its time to establish itself even intellectually. Globally,  if you take the top 50 companies they spend nearly 30-40 percent of their turnover on R&D and  out of this 40 percent comes from VCs. India spends only close to six percent despite a small space. In the Indian market, the concept of VCs is very new and we do not have many VCs. Yet India has done a great job. We  have been able to create an industry which is starting to innovate and identified business models. The Indian biotech story has  not been a failure in anyway. Should there be an industry-academia linkage in biotechnology to promote innovation? Should there be some sort of funding on these lines? The academia-industry linkage has been the engine for innovation. In Indian context,  to deal with the Indian academia is very tough; there is tremendous resistance and the sense of commercial understanding is lacking. The US faced a similar challenge in the 1950s and 1960s  that is when they came out with an act which actually improved the industry-academia linkage and the ability to do commercial research, earlier it was only restricted to journals. India is also planning to propose an act named Public Funded R&D bill, which is inspired by the US act. The act will allow the researcher and the academic institutions to hold the IP right, that is a good incentive because today a researcher thinks he has no stake in the process as the government holds the IP. This act will be a good catalyst and will lead to an effective commercial relationship between the industry and academia. People will be engaged in a meaningful commercial research while they are still on campus and  it  will facilitate a number of research  projects because the infrastructure  gap can be narrowed and can be balanced. Biotechnology as a sector is an answer to so many unanswered issues. We traditionally have not been able to participate  in innovative activities because of lack of funds. I think it is a national issue and not a  company issue. This is a sector where small guys cannot afford and the government funding can be at a project level. The Government of India has also declared that it will allocate $2 billion for R&D but that alone cannot help. If the fund is given individually to companies that will not be a good model. The main intention should be to create a common infrastructure to leverage the strength. So the best way to utilize this fund is to invest in Bt parks, strengthen  academic institutions with best infrastructure  so that within one umbrella a company and institutions can all work together. So here we have limited  investments being  exploited by multiple number of players for innovation. We need to create central infrastructures or shared capabilities and infrastructure. We saw a lot of companies hiving out their R&D units. Was it a feasible model considering that a number of PEs and VCs  backed out  mid way from such ventures? Considering this model, companies wanted to de-risk their generic business because all of them are listed.  The discovery research was sucking up a lot of money  which was impacting the performance of the entire company and in any drug discovery process its a long gestation period. Indian markets and investors do not understand that in a very significant way. So the segregation happened to de-risk their generic business and to bring a clear focus, but unfortunately we are seeing many deals closing. In concept, it was good to have a risk capital and funding for the discovery part, but the expected success  did not happen. Because at the end of the day discovery is long drawn process and you need to have a different  set of investors  with a different mindset who can understand innovation investments. Market and investors will take time to understand this model. From the VC firm’s point of view, how attractive will be the biosimilars market in the near future? Biosimilar market has superior opportunities than pharma generics. Globally we can expect a certain price correction. However  generics are here to stay and  grow in time.  In the US  the generics prescription is 60 percent and with the arrival of Obama it will grow over time. Biosimilar is a subset of generics. Traditionally the market for which big pharma has made branded  products catering to the 1.5 billion population  now this 1.5 billion population is under the strain of genericisation. To have  sustainability, big pharma or big biotech will have no other option but to typically cover the remaining population  which is a semi regulated part of the world and this part will never be able to afford the prices, this is also applicable to biosimilars.  Biosimilars will be a more strong a proposition  than generics because they are difficult and complex to emulate . Today the entire  pharma generic space will see a tremendous price erosion up to 90 percent. That may not happen in biosimilars, the price  erosion may go up to 50-60 percent. What according to you will be the five trends that will dominate the Indian biotechnology industry? We will go the innovation way,  if companies aspire to be in a dignified position, imitation will always put you in a secondary position.  Hence investment in innovation is the right thing, since there are a number of corporate companies in India actively committed to innovation. We will also see government funding in terms of providing finance, getting into PPPs, direct funding,  their role in development of this sector will be primarily as a financier and peer regulator. There will be globalization in biotech. Biotechnology is largely India-centric; in the future, we will be  a part of the global market and will be a part of the pie across the value chain. There will be a lot of marketing alliances  where companies abroad can come and Indian companies will play the role of  CSOs (contract sales organizations). They will look at alliances across the value chain. The public R&D bill will change the dynamics as the industry-academia linkage has an important role to play. Regulations will play an important role for successful implementation of the first three trends.  Lastly on the globalization front, other than business opportunities and capability development, globalization will expose us to actively learn the expertise from the partner, South Korea is a  best example for this. The alliances prepares companies  to go to the next level.   Nayantara Som ]]> <![CDATA[â€œIt is the right time to repeat the success of Bt technologyâ€?]]> https://biospectrumindia.com/news/95/2563/it-is-the-right-time-to-repeat-the-success-of-bt-technology.html https://biospectrumindia.com/news/95/2563/it-is-the-right-time-to-repeat-the-success-of-bt-technology.html Wed, 08 Apr 2009 10:35:00 +0530 “It is the right time to repeat the success of Bt technology” —Clive James, founder and chairman, ISAAA The Bt technology is enhancing the progress of agriculture sector and is catering to the needs of the growing population. Clive James, the founder and chairman of International Service for the Acquisition of Agri-biotech Applications, gives his insights on the Bt crops. What was the status of Bt cotton in India in 2008?  In 2008, India planted Bt cotton on 7.6 million hectares of land equivalent to 82 percent of the total cotton area, up from 6.2 million hectare equivalent to 66 percent of the total cotton area in 2007. A record five million small and resource-poor farmers planted Bt cotton in 2008, which is significantly up from 3.8 million farmers in 2007. It is noteworthy that for a period of seven years (2002-2008), there was a 150 fold increase in Bt cotton cultivation in India. On an average, cotton farmers increased their yield by 31 percent, reduced insecticides application by 39 percent and the net profit increased by $250 (Rs 10,000) or more per hectare due to Bt technology. It is important to note that lepidopteron insects cause heavy losses to crops such as cotton, brinjal, okra and rice. Farmers apply heavy insecticides spray to control these insects but they escape repeated sprays as they bore into different parts of plant and live a concealed life. Bt technology is meant to effectively control lepidopteron insects  and is completely safe for other non-target organisms, animals and human being. What is the status of research on crops other than cotton? Research is being done on cotton which is affected by lepidopteron insects such as American bollworm and pink bollworm and also brinjal that is attacked by fruit and shoot borer. Maize(European corn borer) and Rice(stem borer) are being developed with Bt technology to provide an alternate method for controlling extensive damage caused by borer insects in these crops. Herbicide tolerant (effective weed management) crops such as cotton, maize, wheat, nutritional-enhanced potato and golden rice are also in line. Can you brief us on the  timelines for Bt crops other than cotton? Bt brinjal is at the most advance stage of approval and the Genetic Engineering Approval Committee (GEAC) has approved experimental seed production in 2008. Other crops close to approval process include Bt rice, Bt okra, GM Potato, GM maize etc. It is important to note that these crops are strictly regulated and have to undergo rigorous science-based risk assessment which takes around 5-7 years along with preparation of extensive regulatory package prior to commercial approval. Bt brinjal, since its development in 2000, has undergone rigorous scientific tests, including toxicity and allergenicity evaluation as well as nutritional studies on rabbits, rats, carps, goats, broiler chickens and dairy cows to validate its safety as compared to its non-Bt counterparts. Further studies on pollen escape, effects on soil microflora and non-target organisms, agronomy, invasiveness and Bt protein degradation demonstrated that Bt brinjal does not affect beneficial insects such as aphids, leafhoppers, spiders and lady beetles. What is the role of Bt crops in reducing the usage of pesticides? Bt cotton is a good example of evidence. Traditionally, cotton consumed more insecticides than any other crop in India. The total pesticide market in India in 1998 is valued at $770 million, about 30 percent was dominated by cotton insecticides. This got reduced to 18 percent of the total pesticide market in 2006 whereas the market share for cotton insecticides declined from 42 percent in 1998 to 28 percent in 2006. This saving in insecticides between 1998 and 2006 coincided with the introduction of Bt cotton which occupied 3.8 million hectares equivalent to 42 percent of the hectarage of the cotton crop in 2006. More specifically, the sharpest decline in insecticides occurred in the bollworm market in cotton, which declined from $147 million in 1998 to $65 million in 2006, a 56 percent decrease, equivalent to a saving of $82 million in the use of insecticides to control cotton bollworm in 2006. Thus, insecticides used for controlling bollworm dropped by half when approximately half the cotton area (3.8 million hectares) was benefiting from controlling bollworm using Bt cotton. The introduction of Bt brinjal, Bt rice and Bt maize will further help farmers halve pesticides usages and it also brings the benefits to farmers, consumers and environment.   Which companies are presently involved with Bt research? How do you see the potential of Bt crops in India? There are about 30 Indian private companies and many other public sector institutions are conducting research, focused on Bt and genetically modified crops, in India. The top indigenous companies that have been making substantial investment in R&D and establishing world class seed processing plants for various crops include Mahyco, Rasi Seeds, Vibha Seeds, JK Agrigenetics, Nath Seeds, Bejo Sheetal, Krishidhan Seeds, Bioseeds Research etc. Multinational companies like Monsanto, Bayer, DevGen, Syngenta, Dow AgroScience, Pioneer/Dupont etc. have also been developing collaborations with Indian companies. Bt cotton has doubled cotton production, halved insecticides usages and increased net profit to farmers thus making India the second largest cotton producer in the world. It is the right time to repeat the success of Bt technology in other important food crops.  Nayantara Som ]]> <![CDATA[Bt rice could be launched in India by 2011â€“12]]> https://biospectrumindia.com/news/95/2802/bt-rice-could-be-launched-in-india-by-201112.html https://biospectrumindia.com/news/95/2802/bt-rice-could-be-launched-in-india-by-201112.html Wed, 08 Apr 2009 10:32:00 +0530 Bt rice could be launched in India by 2011–12 India is developing nutritionally enhanced biotech rice that is high in protein, iron and beta-carotene; using less pesticide that could double the yield and save traditional low yielding varieties from extinction… According to the ISAAA report, deployment of biotech rice as a crop is seen as an important step to the adoption of biotech crops globally. Rice is the second most consumed cereal grain, after maize, for a large part of the world’s population, especially in Asia and tropical Latin America. Bt rice is almost ready for adoption, principally the pest/disease resistant biotech rice extensively field tested in China and awaiting approval of the Chinese regulatory authorities. It has the potential to increase net income by approximately $100 per hectare for the 110 million poor rice households in China, equivalent to 440 million people, based on an average of four per household in the rural areas of China. Golden Rice—or genetically biofortified rice with beta carotene that produces vitamin A is being field-tested at the International Rice Research Institute in Los Baños, Laguna. Its adoption for the Philippines is being done by the Philippine Rice Research Institute with two other traits incorporated in the rice—tungro virus and bacterial blight resistance. With over 43 million hectares, India has the largest rice acreage in the world and is the second largest producer of rice with production at 96.43 million tones in 2007-08. With India’s population estimated to reach 1.3 billion by 2017, the Government of India estimates that we may be short of 14 million metric tonnes of food grains. To meet this huge challenge, Indian scientists are working upon developing biotech enhanced rice that has built-in insect protection, rice with high iron and zinc and golden Indica rice, Xa-21 rice for bacterial blight resistance. Leading institutes like International Rice Research Institute (IRRI), Philippines, and Central Rice Research Institute (CRRI), Cuttack, are conducting research in the areas of disease resistance, weedicide control and nutrition enhancement with beta carotene and iron fortification. After all the required processes and approvals, it is estimated that biotech enhanced rice could be launched in India by 2011 –12. While commenting on the role played by Bt rice in food security, Dr Swapan Datta, professor, University of Calcutta said, “Plant biotechnology has the potential to enhance productivity of crops, including rice while addressing the problems of rising food needs. Biotech enhanced rice could double the yields of crops and can save traditional low yielding varieties from extinction by converting taller varieties into shorter heights with multiple tillers resulting in higher yields. Biotech rice and new generation rice tolerant to drought, salinity and cold will provide better adaptation to challenge the threat of global climate change.” Dr GJN Rao, head, plant improvement, CRRI, Cuttack, Orissa said, “Biotech rice has a clear advantage. It can address many of the production constraints in India, enhance productivity and help protect the environment by reducing the use of chemical pesticides. Since India is also home to the world’s largest number of malnourished people, most of whom are women and children, CRRI is working on developing nutritionally enhanced rice for high protein and high-iron. Using conventional means and transgenic approach, we are developing rice varieties for incorporating resistance to diseases and insects and abiotic stresses like drought.” Recently, an agreement was signed between Indian Council of Agricultural Research (ICAR) and IRRI to support and facilitate India’s rice research for the next three years, helping the nation’s rice production at a time of new challenges such as global climate change, increased cost of production, value addition and the revitalization of food production.   In addition to CRRI Cuttack, some of the Indian Institutes that are conducting research on biotech rice include University of Calcutta,  Bose Institute, Directorate of Rice Research,  National Research Center on Plant Biotechnology, University of Delhi, Tamil Nadu Agriculture University, Madurai Kamaraj Unviersity,  Osmania University and MS Swaminathan Research Foundation, Chennai. ]]> <![CDATA[Bt crops: India ranks fourth]]> https://biospectrumindia.com/news/95/2539/bt-crops-india-ranks-fourth.html https://biospectrumindia.com/news/95/2539/bt-crops-india-ranks-fourth.html Wed, 08 Apr 2009 10:08:00 +0530 Bt crops: India ranks fourth Bt crops: India ranks fourth India has come a long way since its adoption of Bt cotton in 2002. It is ranked fourth in the world among Bt crops growing countries, in terms of hectares. With a number of other Bt crops under research, the country is heading for a bigger share of the pie in the next few years. The year 2008 had been a year of robust growth for biotech crops according to the latest report released by the International Service for the acquisition of agri-biotech applications (ISAAA). Being in the 13th year of the commercialization of GM crops globally, the report outlines that the year saw millions of small and resource poor farmers worldwide plant more hectares of biotech crops owing to the substantial economic, environmental and welfare benefits offered by biotech crops. Last year also saw an increase in the hectarage of biotech crops; the number of countries and farmers planting them; substantial progress in Africa, increased adoption of stacked traits and the introduction of new biotech crops. These are very important developments given that biotech crops can contribute to some of the major challenges facing global society, including food security, high price of food, sustainability, alleviation of poverty and hunger, and also help mitigate some of the challenges associated with climate change. Three new countries join the biotech bandwagon With only six countries growing biotech crops in 1996, 25 countries today are following the league with Burkina Faso, Egypt and Bolivia being the three new countries to adopt biotech crops in 2008. Of these, two (Burkina Faso and Egypt) are in Africa, thus making it the continent with significant progress from one country in 2007(South Africa) to three countries in 2008. While Burkina Faso took the decision to grow 8,500 hectares of Bt cotton for seed multiplication and initial commercialization, Egypt decided to commercialize 700 hectares of Bt maize in 2008. This is of strategic importance for the African continent given the fact that Africa is home to over 900 million people representing 14 percent of the world population and is the only continent in the world where food production per capita is decreasing and where hunger and malnutrition afflicts at least one in three people. In December 2008, Kenya, a pivotal biotech crop country in East Africa, enacted a biosafety law, which will facilitate the adoption of biotech crops. Another trend noticed was that there were a higher number of developing countries (15) as opposed to industrial countries (10) in 2008. Each of  the top eight countries grew more than one million hectares of Bt crops: US (62.5 million hectares (mn ha)), Argentina (21.0 mn ha), Brazil (15.8 mn ha), India (7.6 mn ha), Canada (7.6 mn ha), China (3.8 mn ha), Paraguay (2.7 mn ha), and South Africa (1.8 mn ha). India with a high 23 percent growth rate between 2007 and 2008 narrowly displaced Canada for the fourth ranking position globally in 2008. Five countries adopt new biotech crops Not only did the year see a new biotech crop being cultivated, but also saw more countries growing biotech crops that have already been commercialized in other countries. RR herbicide tolerant sugar beet was introduced for the first time globally in the USA(2.6 lakh hectares) and on a small hectarage in Canada. The percentage of adoption in 2009 is expected to be close to 90 percent as opposed to 2008, where it was a substantial 59 percent. Five countries including Egypt, Burkina Faso, Bolivia, Brazil and Australia introduced, for the first time, biotech crops that have already been commercialized in other countries. Bolivia planted 6 lakh hectares of RR soybean, Brazil and Egypt planted Bt maize, Burkina Faso planted Bt cotton and Australia planted Bt canola. Bolivia is the eighth largest grower of soybean in the world and is today the ninth country in Latin America to benefit from the extensive adoption of biotech crops. Global hectarage of biotech crops reaches 125 million hectares In 2008, the global hectarage of biotech crops continued to grow strongly reaching 125 million hectares, up from 114.3 million hectares in 2007. This translates to an “apparent growth” of 10.7 million hectares (the sixth largest increase in 13 years) or 9.4 percent when measured in hectares. The year also saw the planting of the second-billionth acre (800 millionth hectare) of a biotech crop – only three years after the first one-billionth acre of a biotech crop was planted in 2005 which took 10 years. Bt crops with stacked traits on a high The stacked double and triple traits occupied a larger area (26.9 million hectares, or 22 percent of global biotech crop area) than insect resistant varieties (19.1 million hectares) at 15 percent. Stacked traits (as opposed to single traits in one variety or hybrid) in cotton and maize were deployed by 10 countries – US, Canada, Philippines, Australia, Mexico, South Africa, Honduras, Chile, Colombia, and Argentina, with more countries expected to adopt stacked traits in the future. A total of 26.9 million hectares of stacked biotech crops were planted in 2008 compared with 21.8 million hectares in 2007. In 2008, USA led the way with 41 percent of its total 62.5 million hectares of biotech crops stacked, including 75 percent of cotton, and 78 percent of maize. The fastest growing component of stacked maize in the US was the triple stacks conferring resistance to two insect pests plus herbicide tolerance. Double stacks with pest resistance and herbicide tolerance in maize were also the fastest growing component in 2008 in the Philippines doubling from 25 percent of biotech maize in 2007 to 57 percent in 2008. In 2008, herbicide tolerance deployed in soybean, maize, canola, cotton and alfalfa occupied 63  percent or 79 million hectares of the global biotech area of 125 million hectares. Biotech maize, most planted crop In 2008, 17, or two-thirds of the 25-biotech countries planted biotech maize (same as in 2007), 10 countries planted biotech soybean (up from nine), 10 countries planted biotech cotton (up from nine) and three countries planted biotech canola (up from two in 2007). In addition, two countries the US and China grew virus resistant papaya, two countries Australia and Colombia grew biotech carnation, a small hectarage of Bt poplar grown in China, and Bt squash and alfalfa in the US. About 13.3 million farmers benefit from Bt crops worldwide Of the global total of 13.3 million beneficiary biotech farmers in 2008, (up from 12 million in 2007), remarkably over 90 percent or 12.3 million (up from 11 million in 2007) were small and resource-poor farmers from developing countries; the balance of one million were large farmers from both industrial countries such as the US and Canada and developing countries such as Argentina and Brazil. Of the 12.3 million, most were Bt cotton farmers with the highest, 7.1 million in China followed by 5.0 million in India. The largest increase in the number of beneficiary farmers in 2008 was in India where an additional 1.2 million more small farmers planted Bt cotton which now occupies 82 percent of total cotton cultivation, up from 66 percent in 2007. Biotech crops have improved the income and quality of life of poor farmers In 2008, five million small farmers, (up from 3.8 million farmers in 2007) in India benefited from planting 7.6 million hectares of Bt cotton. Benefits will vary according to varying pest infestation levels in different years and locations. A conservative estimate for small farmers indicates that yields increased by 31 percent, insecticide decreased by 39 percent, and profitability increased by 88 percent equivalent to $250 per hectare. About 7.1 million small and resource-poor farmers benefited from Bt cotton in China in 2008, based on studies conducted by the Center for Chinese Agricultural Policy (CCAP), it was concluded that, on an average, small farmers adopting Bt cotton increased yield by 9.6 percent, reduced insecticide use by 60 percent, with positive implications for both the environment and the farmers’ health, and generated a substantial $220 per hectare increase in income. The global value of biotech crop market was at $7.5 billion in 2008 In 2008, the global market value of biotech crops, estimated by Cropnosis, was $7.5 billion, (up from $6.9 billion in 2007) representing 14 percent of the $52.72 billion global crop protection market in 2008, and 22 percent of the approximately $34 billion global commercial seed market in 2009. The value of the global biotech crop market is based on the sale price of biotech seed plus any technology fees that apply. The global value of the biotech crop market is projected at approximately $8.3 billion in 2009. Status of field trials of biotech/GM crops in India, 2008 Crop Organization Transgene/Event Brinjal IARI, New Delhi; Sungro Seeds, New Delhi; Mahyco, Jalna TNAU, Coimbatore; UAS, Dharwad; and Bejo Sheetal, Jalna. cry1Aabc cry1Ac cry1Ac cry1Ac cry1Ac cry1Fa1 Cabbage Nunhems, Gurgaon; Sungro Seeds, New Delhi; and Mahyco, Jalna. cry1Ba and cry1Ca cry1Ac cry1Ac Castor Directorate of Oilseeds Research (DOR), ICAR, Hyderabad. cry1Aa and cry1Ec Cauliflower Mahyco, Jalna; Sungro Seeds, New Delhi; and Nunhems, Gurgaon. cry1Ac cry1Ac, cry1Ba and cry1Ca cry1Ac, cry1Ba and cry1Ca Corn Monsanto, Mumbai. Mon89034 Groundnut ICRISAT, Hyderabad. Rchit and DREB Okra Mahyco, Mumbai; Sungro Seeds, Delhi; Bejo Sheetal, Jalna; and Arya Seeds, Gurgaon. cry1Ac cry1Ac cry1Ac CP-AV1 Potato CPRI, Shimla; and NCPGR, Delhi. RB Ama1 Rice IARI, New Delhi; TNAU, Coimbatore; MSSRF, Chennai; DRR, Hyderabad; Mahyco, Mumbai; Bayer CropScience, Hyderabad; and Avesthagen, Bangalore. cry1Aabc, DREB, GR-1 & GR-2 (Golden Rice) chi11 MnSOD cry1Ac cry1Ac, cry2Ab cry1Ac, cry1Ab, bar NAD9 The next decade of Bt Crops (2009-2015) According to the report, the future surely belongs to Bt crops with more than 40 countries expected to adopt biotech crops. About 15 or more countries are projected to plant biotech crops for the first time during 2009-2015 including 3-4 each in Asia, eastern and southern Africa and West Africa, 1-2 in North Africa and the Middle East, 2-3 countries in Latin/Central America and the Caribbean and six in eastern Europe including Russia, which has a biotech potato at an advanced stage of development. While the first decade (1996-2006) was dominated by America; the second decade, will witness more growth in Asia and  Africa with growth in stacked traits, particularly in North America and Brazil. Biotech maize, named Smartstax, is expected to be released in the US in 2010 with eight different genes coding for several pest resistant and herbicide tolerant traits. Future stacked crop products will comprise both agronomic input traits for pest resistance, tolerance to herbicides and drought plus output traits such as high omega-3 oil in soybean or enhanced pro-vitamin A in golden rice. Drought tolerance conferred through biotech crops is viewed as the most important trait that will become available by 2015, because it is by far the single most important constraint to increased productivity of crops worldwide. Drought tolerant Bt maize, is the most advanced of the drought tolerant crops under development, and is expected to be launched commercially in the USA in 2012, or earlier. A private or public sector partnership hopes to release the first biotech drought tolerant maize by 2017 in Sub-Saharan Africa. The future adoption of biotech crops in developing countries will be dependent on a host of factors like establishment and effective operation of appropriate, responsible and cost/time-effective regulatory systems and strong political will and support for the adoption of biotech crops that can contribute to a more affordable and secure supply of food, feed, and fiber. While the first generation biotech crops realized a significant increase in yield and production by protecting crops from losses caused by pests, weeds, and diseases, the second generation biotech crops will offer farmers additional new incentives for further increasing yield. RR2 soybean, to be launched in 2009, is the first of many such second-generation products that will further enhance the yield from 7 to 11 percent. Deployment of biotech rice is also seen as a crop seminal for catalyzing the further adoption of biotech crops globally. Bt rice is almost ready for adoption, principally the pest/disease resistant biotech rice extensively field tested in China and awaiting approval by the Chinese regulatory authorities; and Golden Rice expected to be available in 2012. Several medium hectarage crops are expected to be approved before 2015 including potatoes with pest and/or disease resistance and modified quality for industrial use; sugarcane with quality and agronomic traits; and disease resistant bananas. Some biotech orphan crops are also expected to become available. For example, Bt eggplant may become available as the first biotech food crop in India within the next 12 months and has the potential to benefit up to 1.4 million small and resource-poor farmers. Vegetable crops such as biotech tomato, broccoli, cabbage and okra which require heavy applications of insecticides (which can be reduced substantially by a biotech product) are also under development. Pro-poor biotech crops such as biotech cassava, sweet potato, pulses and groundnut are also included in the list. It is noteworthy that several of these products are being developed by public sector national or international institutions in the developing countries. The development of this broad portfolio of new biotech crops augurs well for the continued global growth of biotech crops, which ISAAA projected to reach 200 million hectares by 2015, grown by 20 million farmers, or more. However, by far, the most important potential role of biotech crops will be their contribution to the humanitarian Millennium Development Goals (MDG) to ensure a secure supply of affordable food and the reduction of poverty and hunger by 50 percent by 2015, the report notes. Increasing political will The 2008 World Bank Development Report emphasized that, agriculture is a vital development tool for achieving the Millennium Development Goals that calls for halving the share of people suffering from extreme poverty and hunger by 2015. It recognizes that the revolution in biotechnology and information technology offer unique opportunities to use agriculture to promote development, but also cautions that there is a risk that fast-moving crop biotechnology can easily be missed by developing countries if it lacks political will and international assistance. The year 2008 saw the growing “political will” for biotech crops at an international level. The G8 leaders’at a  meeting in Hokkaido Japan in July 2008 gave a  statement on biotech crops that  reads as follows, “We have to accelerate research and development and increase access to new agricultural technologies to boost agriculture production; we will promote science-based risk analysis, including the contribution of seed varieties developed through biotechnology.” While the European Commission stated that “GM crops can play an important role in mitigating the effects of the food crisis.” China committed an additional $3.5 billion over twelve years with Premier Wen Jiabao (Chairman of the State Council/Cabinet of China) expressing China’s strong political will for the technology. All seven European Union (EU) countries increased their Bt maize hectarage in 2008, resulting in an overall increase of 21 percent to reach over 100,000 hectares. In 2008, seven of the 27 countries in the EU officially planted Bt maize on a commercial basis. The seven EU countries listed in order of biotech hectarage of Bt maize were Spain, Czech Republic, Romania, Portugal, Germany, Poland and Slovakia.  Source:ISAAA report, Brief 39 ]]> <![CDATA[Lupin's biological pursuit]]> https://biospectrumindia.com/news/95/2464/lupins-biological-pursuit.html https://biospectrumindia.com/news/95/2464/lupins-biological-pursuit.html Tue, 07 Apr 2009 12:59:00 +0530 Lupin’s biological pursuit Dr Kamal Sharma, managing director, Lupin, Mumbai. Having consolidated itself in the generics space, Lupin Pharma has now marked biologics as a top priority within the radar of its overall expansion plans Lupin Pharma has been very aggressive in the last few months announcing a spate of overseas acquisitions, capacity expansion plans and now its foray into biological venture. A statement made by company Chairman, Dr DB Gupta earlier last year categorically mentioned, “We have planned to make substantial investments in this area as we believe biotechnology is the frontier area of technology. Over 40 percent of all future discoveries in pharmaceuticals are expected from biologicals. I believe concrete outcome of our research work done should start getting market recognition soon. Our innovative research is focused largely on four areas--New Chemical Entity Research, New Biological Entity Research, Advanced Drug Delivery Systems Research, and Innovative Generics Research. In all these areas a sound base has been created including initiation in the Biotech area.”   Overall too, it has been all sunshine for Lupin Pharma which posted a consolidated net profit for the year ended March 31, 2008,  of Rs 408.25 crore  up by 32 per cent. Total income increased from Rs 2,212.76 crore for the year ended March 31, 2007 to Rs 2,912.82 crore for the year ended March 31, 2008. Chunk of the revenue share came from international operations. The company’s biotech sojourn began  two years back when it set up an R&D unit  dedicated just to specialized research and development of  a basket of proteins. From then on the company has moved on at a breakneck speed.  Dr Kamal Sharma, managing director, Lupin said, “We initiated our biological venture  two years ago and obviously we began with plans of going into the R&D space. Within this period, we have developed some proteins and some monoclonal antibodies too, some of them are in advanced stages of development and some of them are in the intermediary stages of development” New manufacturing unit and investments Moving ahead, the company now does not want to leave any stone unturned in its biological venture. It has already made some significant investments in establishing a research unit for biosimilars namely the Lupin Biosimilars Research organization and new biological entities. This is not all. As a stepping stone to its biological dreams, Lupin is now setting up its own manufacturing unit in Pune which is likely to be commissioned in the coming months. While the  Lupin Biosimilars Research organization in Pune is fully operational, the manufacturing and technical arms are being currently ramped up. Lupin has developed several biosimilars as well as delivery platforms for proteins and completed pilot work on two monoclonal antibodies of global potential. “We set up a manufacturing unit which will be commissioned in the course of the next three months  in Pune. Here, we are going to take up the clinical manufacturing of the proteins we have developed  already and then put them for regulatory approval. It is a CGMP facility,” added Dr Sharma. When the manufacturing facility is ready, it would offer facilities for any clinical production or contract manufacturing services which overseas companies may require. Thus the setting up of its technological and manufacturing arm is not just an extension but a catalyst to further Lupin’s biologics strategy both in India and overseas markets. Disease segment of prime importance for Lupin in biologicals will be cancer, cardiovascular and rheumatoid arthritis. Lupin aims to reach all key global markets including the US, Europe, India, Brazil, Mexico, Turkey, Saudi Arabia, Argentina and Russia. Investments As far as investments go, funds and finances could go up to the tune of Rs 250 crore  for Lupin’s entire biological initiative with the entire amount being raised from internal accruals alone. However it is here that Lupin wants to take it up one at a time. “Obviously in trying to respect the economics of the business, we have kept  it in a manner that we do not invest too much money upfront and invest as and when required. We have not allocated any separate budget  but whatever initiative is taken, we  look at it as a return on investment ranging between 25-30 percent.  Unless that return on investment is insured we do not take a step ,” confirmed Dr Sharma  Dr Sharma, who is spearheading the company’s biological initiatives has a different mantra to keep the business up and running . He quipped, “What drives us is output not input. I am an advocate of concentrating more on output than input. It would make economic sense to have  a situation where 50 people can create a Rs 500 crore business; a four acre plot generating Rs 400 crore business rather than making huge investment and getting nothing out of it.” The same goes with its manpower investments too. In the span of two years, the company ramped up its workforce to over 35 and now with the setting up of its manufacturing unit and technological arm, it intends to beef up its total workforce to 100 and above which will be divided into research, manufacturing and Q/A. Lupin is looking at focusing on the right number of high quality people which will be  determined more by the needs of the  business. Strategy Venturing into the manufacturing is in line with  the overall blueprint of Lupin’s broad strategy. The company’s  business model consists of four components which is in-licensing products (wherein the company has already in-licensed products for biologics in the market); having its own manufacturing plant; scouting partners for taking an early stage product into clinical development including co development in India; and last, forging marketing alliances. “Our  technology and manufacturing strategies are going to be different as this is altogether a different science. But the new strategy for technology and manufacturing will dovetail into our main line strategy  for putting the product into the market. So we are starting with a new technology platform which is biologicals, starting with biosimilars moving into New Biological Entities for which we will enter into codevelopment and  in licensing  for early deals,” added Dr Sharma.   Looking at the macro level, getting into an acquisition or an alliance with a “strategic fit” has always been Lupin’s core strategy and it intends to emulate the same in its biotech model as well. “We do not acquire for the sake of becoming big but we are acquiring for the sake of adding strength to our base model. This can be done only by two methods. One is to acquire in the market you want  to enter  which is difficult to enter in an organic way  or you acquire a  technology platform to add to  your business. It is this that will be applied to our biopharmaceuticals model as well,” Dr Sharma said. Lupin’s manufactured products  is estimated to be out in the market by the end of  2010 It is a prerequisite in the company’s agenda  that the products are  first launched in India and then in overseas markets. In the process, the company will  start developing partnerships. Partnerships will go concurrent. Looking into the future The share of biologics in Lupin’s total revenues would be minuscule in the next one year, despite in-licensing deals and marketing alliances. The company is looking at a business turnover of Rs 100 crore from this business in the initial years and gradually increase the share of revenues from the biologics business to 10 percent over the next seven-eight year’s time. On a final note, Dr Sharma added optimistically, “I can confidently say, that we have gone into the biologics space at the right time. The regulatory pathway for biosimilars is just up in the US . It will take another 3-4 years before it gets settled into a well defined pathway. By then our technology and manufacturing would have graduated to a higher level by then which makes work easier for us and help us ink further alliances. I am pretty much excited about that.”   Nayantara Som ]]> <![CDATA[Asian CMOs in demand]]> https://biospectrumindia.com/news/95/2489/asian-cmos-in-demand.html https://biospectrumindia.com/news/95/2489/asian-cmos-in-demand.html Tue, 07 Apr 2009 12:54:00 +0530 Asian CMOs in demand Asia never had it so good. Multinational pharma companies are de-risking their R&D manufacturing by outsourcing it to Asian contract research and manufacturing companies—in turn effecting substantial cost savings and keeping their faith in Asian capabilities The global pharmaceutical industry has been facing many challenges in the form of increasing competition from generics, rising cost of new product development, declining research and development (R&D) productivity, shrinking average patent life, and mounting governmental pressure to reduce drug prices. Given the backdrop of such a competitive landscape, the decisive factors for growth and sustainability are faster new drug development and cost containment with “contract manufacturing” emerging as a strategic option offering several advantages. Firstly, outsourcing provides pharmaceutical companies the opportunity to avail flexibility, quicker time- to-market, and lower scale-up costs. Thus, companies are able to meet growing demand for new drugs and focus on their core competencies. Secondly, outsourcing enables companies to reduce excess capacity in their manufacturing networks and restructure supply chains. Finally, value-added outsourcing services meet the increased demand for specialized manufacturing capabilities in key technical niches and increased demand for back-up sources of supply. The global contract manufacturing market was about $38 billion in 2007 as per ValueNotes & Know Genix estimates and is expected to grow at CAGR of eight percent by 2010 to touch $49 billion. Global market for pharmaceutical contract manufacturing is estimated at $20.4 billion for 2008, notes Global Industry Analysts. The US is the single largest market for pharmaceutical contract manufacturing with revenues projected to be $12.8 billion in 2012. In terms of revenues, although North America and Europe are the largest markets, Asia with its immense manufacturing capacity is projected to exhibit robust growth. Exhibiting a CAGR of nearly 16 percent, Asia Pacific is expected to emerge as the fastest growing region in the global pharmaceutical contract manufacturing market. Injectables represent the fastest growing product segment, and are forecast to record revenues of $10.6 billion by 2015. Solid Dosage Forms, the largest segment, is vibrant with a projected market value of $12.3 billion for 2010. The European and North American pharmaceutical contract manufacturing sector has been categorized into three tiers. Tier 1 companies offer end-to-end services ranging from clinical trials to commercial manufacturing, logistics, packaging, and marketing assistance. Tier 2 companies provide services ranging from early stage project development to commercial level manufacturing. Tier 3 companies are conventional manufacturing companies, which address the needs of the generic drugs industry. However, contract manufacturing in Europe is dominated by generic drug variants, while in North America branded versions are preferred. In Asia, numerous local players operate in the market. Key global market participants include Althea Technologies, Catalent Pharma Solutions, Dishman Pharmaceuticals and Chemicals, DSM Pharmaceuticals, HAUPT Pharma AG, Jubilant Organosys, Kemwell, Nipro Corp, NextPharma, Patheon, and Penn Pharmaceutical Services. The Asian contract manufacturing organizations (CMOs) account for an ever-expanding share of global pharmaceutical manufacturing and is expected to account for around $3.3 billion of the total projected $23 billion CMO market by 2010. A growing number of CMOs have obtained US Food and Drug Administration (FDA) approval for their operations and completed good manufacturing practice (GMP) certification. Asian countries provide a significant cost advantage with manufacturing savings of upto 50-80 percent of the cost that would be incurred, if the manufacturing is undertaken in western territories. The governments in the region are encouraging local companies to shift to  the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (jointly referred to as PIC/S)—two international instruments between countries and pharmaceutical inspection authorities, which provide together an active and constructive cooperation in the field of GMP. In South East Asia, Malaysia and Singapore have joined this PIC/S, which currently has 33 participating authorities including WHO, Unicef, EMEA and EDQM. Thailand and Philippines are soon expected to join this scheme. This will boost the volume of manufacturing activities to the region. Frost & Sullivan says the region will continue to hold its lure with low production costs, increasing reliant manpower, incentives from the local governments to lure CMOs, implementing IP laws to assure companies of the viability of producing/outsourcing to their countries and expanding healthcare markets in the growing economies. These factors are supporting the Asian CMOs to secure more outsourcing orders from big pharmaceutical companies. In India, for example, there are close to 100 FDA-approved pharmaceutical facilities—the largest number in any country outside the US. Chinese company Zhejiang Huahai Pharmaceutical became the first company to get FDA approval in 2007 and is expected to start exporting its finished drug to the US by 2012. Opening of USFDA office in China in November 2008 is testimony that more companies in China are looking for the US approval and exporting their drugs to the western markets. All these make the region an attractive destination for pharmaceutical contract manufacturing. PricewaterhouseCoopers notes that Asian countries provide a significant cost advantage for pharmaceutical manufacturing. The overall costs of drug manufacturing in India, for example, are up to 50 percent cheaper than in western territories. Cost savings on this scale present a compelling reason for manufacturing outsourcing to Asian CMOs. However, cost savings are nothing compared to the need to ensure quality and safety. The reports of deaths linked to contaminated heparin in the US sourced from China highlight the critical issue of quality. The general trend, however, is of ever-increasing quality of work from Asian territories. To overcome these safety and quality issues the governments in region are taking measures to provide quality healthcare to the public. Besides regulatory system in place, the region has a large pool of educated and appropriately qualified talent with the ability to run manufacturing plants matching western complexity and quality. Several CMOs operating out of Asia have obtained approval from the FDA gaining credibility for their quality standards. China completed Chinese Good Manufacturing Practice (GMP) certification as far back as July 2004 on all the drug manufacturers in the territory. At the end of 2005, more than 5,000 Chinese drug manufacturers had obtained their Chinese GMP certificates. There is an ongoing effort in China to increase inspections on already certified manufacturing sites, in response to evidence that some of the certified manufacturers have not consistently adhered to GMPs in the past. With an increased commitment to international standards, Asian CMOs are securing more outsourcing orders from big pharmaceutical companies. The commitment to Western standards is also being reflected in the modernization of plants, and moves to innovate through the development of technologies, to ensure facilities are ready to meet future manufacturing needs. PricewaterhouseCoopers (PwC) also notes that China and India, followed by Korea and Taiwan, are now providing an atmosphere for the pharmaceutical industry where benefits such as the pool of educated and qualified scientists, intellectual property law reform and market growth are outweighing factors that had previously inhibited development, principally uncertain regulatory frameworks and enforcement. It also noted that Singapore is best suited for complex and technology intensive manufacturing. Among the hotspot territories, it has access to the best technology and funding for outsourcing high-technology intensive products. Apart from this, Singapore also has extremely well regulated IP protection and enforcement regime, and is considered one of the best among all Asian territories in terms of regulatory compliance. Along with Australia, Singapore has consistently topped the rankings as the top Asian territory for IP protection and enforcement. Singapore is able to attract companies like Lonza besides being home to local companies like A-Bio and Beacon Pharmaceuticals.   ]]> <![CDATA[NATION'S BIGGEST PHARMACEUTICAL LEADERSHIP SUMMIT]]> https://biospectrumindia.com/news/95/2470/nations-biggest-pharmaceutical-leadership-summit.html https://biospectrumindia.com/news/95/2470/nations-biggest-pharmaceutical-leadership-summit.html Wed, 25 Mar 2009 11:35:00 +0530 â€œProceeds from the Summit to go towards feeding school childrenâ€? Malvinder Singh, Kiran Mazumdar, Kewal Handa, Anuj Saxena among others to address the summit CORPORATE PHARMA LEADERS TO DEBATE IN PHARMACEUTICAL LEADERSHIP SUMMIT India's finest think-tank will attend to debate, discuss and find solutions on burning issues facing the Industry today on 3rd April, 2009. India's commercial capital and the Corporate Headquarters of many top ranking companies Mumbai will host Nation's Biggest Pharmaceutical Leadership Summit â€œThe Pharmaceutical Leadership Summit 2009â€? under the theme Destination India â€“ Challenges & Oppurtunities, to be held in Hotel Renaissance Mumbai Hotel and Convention Centre in Grand Ball Room # 2 & 3B, Near Chinmayanand Ashram, Powai, Mumbai 400 087 on Friday, 3rd April 2009 . The one day summit is being organized with a view to bring together leaders from the industry and crystallize their views and thoughts and assist the industry to find solutions and strategies to help the Indian pharma industry face challenges adroitly and seize opportunities as they arise. The who's who of pharma industry like Kiran Mazumdar of Biocon Lid, Kewal Handa of Pfizer Ltd, Anuj Saxena of Elder Healthcare, Dr Ramakant Panda of Asian Heart Institute, Ranjit shahani of Novartis and a host of other big wigs will be debating some of the crucial topics of tremendous significance confronted by the industry. More than 400 industry professionals, Pharma Academia,bureaucrats,medical practioners will be attending the high profile event. Apart from the Indian industry the summit will also see sizable presence of professionals from Srilanka, Bangladesh, Middle East, United states and other countries with close pharma relations with India. By hosting the Pharma summit at a time when the nation is being rocked by instability in the economy and the corporate world, the organizers also wish to send out a message that while some other sectors have been adversely affected, the Pharma and associated industry continue to progress and have managed to shrug off the effects of the depression across the world. It is also the right time for the industry to rise and review its performance, its people and assess the requirements of the industry. The summit provides a perfect opportunity for all players in the pharma world to come together and learn from the leaders of the industry. The Summit is deliberating many critical topics of tremendous significance confronted by the Industry. Some of the Topics like The other notable speakers include, Malvinder Singh of Ranbaxy, Mr Ranjit Shahni, MD, Novartis India Ltd.,Mr Kewal Handa, Managing Director, Pfizer Ltd , Dr Anuj Saxena, MD, Elder Healthcare Ltd, Mr. Ajit Singh, Chairman, ACG World Wide,Mr. Ramesh L. Adige, Executive Director, Corporate Affairs & Global, Corporate Communications, Ranbaxy Ltd, Mr.Anand Balasundaram, MD, Astra Zeneca Pharma Inida Pvt Ltd, Mr. Venkat Jasti, MD, Suven Life Sciences Ltd, Mr Alok Mishra, Sr President,- operations, VHB Medisciences Ltd, Neopharma LLC, Mr Sanjiv Dharwadkar Sr. Director Pharma, Aventis Pharma Ltd, Mr Deepak Naik, MD, Eisai Pharma Pvt. Ltd, Narayan Gad, CEO-Formulations, Panacea Biotech Ltd, Dr. Himadri Sen, President R&D, Ranbaxy Ltd, Dr. Suresh Jadhav Executive Director Serum Institute of India Ltd, Dr P.M.Nayak, Project Director, Zydus Cadila Ltd, Mr Kaushik Desai, Director & CEO, Global Pharmatech, Mr Shailesh Siroya, MD, Bal Pharma Ltd, Mr M.Prashant, VP, Business Devlopment, Sarvotham Remedies Ltd, Mr V.S.Reddy, MD, British Biologicals, Mr J.A.S.Giri, Chairman, Sangfroid Industries Ltd, Dr R.B.Smartha, MD, One unique aspect of the summit is that it is being held in aid of Akshaya Patra, the world's largest run school meal program which is feeding around one million school children everyday across India. Recently even President-Elect Obama had also commended the organisation for the yeomen service it is doing by providing humanity by feeding poor school children across India.The event is being held in association with Pharmaexicil, Indian Drug Manufaturer's Association, Indian Pharmaceutical Associations and the Orgainsation of Pharmaceutical products of India. For further details please contact: Mr. Raj : + 91 9740622225, kraj@akshayapatra.org Ms. Rajani : + 91 9900169159, rajani@akshayapatra.org ABOUT THE AKSHAYA PATRA FOUNDATION The Akshaya Patra Foundation, a non-profit, Bangalore-based secular trust, evolved the free meal program in schools in the year 2000. What started as a pilot project in five schools in Bangalore, feeding 1,500 children, has now grown into a mammoth endeavor covering over 9,83,000 children in over 5,700 government, government aided schools and anganwadis (day care centers) in 17 locations spread across seven states in India, day after day. This is amongst the largest school meal NGO run program in the world. The foundation expects to reach a magical figure of five million children by 2020. Six days a week, without a stop, the foundation provides unlimited, nutritious, hygienically cooked noon meals in government schools and government-run day-care centres (anganwadis), Ushering in a technology-intensive operating model that ensures high-quality, hygienic food on the one hand and increases internal efficiencies on the other, the program has brought about policy changes at the state government levels and created a new image for mid-day meals in India. Akshaya Patra is an eloquent demonstration of public private partnership as it is run with part subsidies from the government, besides financial support from corporates and individual philanthropists. The daily expenses: around Rs 35 Lakh! The program is independently governed by a Board of Trustees, an Advisory Panel consisting of professionals from the corporate world & bureaucracy, dedicated employees and a team of volunteers. The program is advised in rigorous accounting standards and services by KPMG to ensure transparency and accountability to all its donors. A study in the year 2006 by AC Nielsen Org Marg, has vouchsafed for the efficacy of the program in increasing attendance in schools, improving nutritional status of these children, enhancing their learning abilities and reducing drop out rates. The foundation's work has been praised by all quarters and a recent feather in its cap has been the study conducted by Harvard Business School. All contributions to The Akshaya Patra Foundation are eligible for 100% tax deduction under section 35AC/80GGA (bb) of the Income Tax Act 1961 in India For further details please visit our website: www.akshayapatra.org ]]> <![CDATA[Mesenchymal Stem Cells, a Promising Tool for Regenerative Medicine]]> https://biospectrumindia.com/news/95/2516/mesenchymal-stem-cells-a-promising-tool-for-regenerative-medicine.html https://biospectrumindia.com/news/95/2516/mesenchymal-stem-cells-a-promising-tool-for-regenerative-medicine.html Wed, 11 Mar 2009 10:23:00 +0530 Mesenchymal Stem Cells, a Promising Tool for Regenerative Medicine -Dr. Chandra Viswanathan, senior vice president, Regenerative Medicine Group, Reliance Life Sciences Regenerative medicine is a new way of treating diseases using human stem cell-based therapies. Unlike most molecular medicines for chronic conditions, regenerative medicine has the potential of returning the patient to health. Stem cells are unspecialized ‘master’ cells in the human body having a unique capacity to multiply and differentiate into many types of specialized cells and tissues.  Stem cells exist at all stages of human development from early embryos to fetuses to adults.  In general, there are three types of stem cells: embryonic, fetal and adult. Embryonic stem cells, although very versatile, continue to face ethics related controversies. Mesenchymal stem cells Mesenchymal stem cells (MSCs) are classically defined as CD34 negative, CD45 negative, SH2 and SH4 positive, and Thy-1 (CD90) positive cells. These are adult stem cells traditionally isolated from bone marrow (BM) aspirates. These are spindle-shaped, and during culture, adhere to plastic. These can be expanded in culture while maintaining their ‘stemness’.  These have the capacity to differentiate into a wide variety of mesenchymal tissues and also cross lineage boundaries. MSCs qualify to serve as a broadly applicable stem cell source for regenerative medicine, repopulating injured tissues and clinically ablated diseased tissues with healthy, terminally differentiated and tissue-specific cells. Thus, so far, several hundred patients have received systemically and locally infused MSCs for various indications, and there are good observations made from those. MSCs have the capacity to differentiate into mature cells and populate the resident tissue, giving them a therapeutic potential for regenerative medicine; secrete cytokines or other soluble mediators and serve as a vehicle for delivery of proteins i.e. gene therapy may be tried through one or more routes using different dosages. Since the mid 1990s, the safety of MSCs has been established, after which there has been an effort to show that co-infusion of MSC could hasten the time for hematopoietic stem cell engraftment, since they could possibly rebuild the marrow micro-environment. More recently, the immunosuppressive capacity of MSC has taken center stage, but the mechanism is still under debate. Literature review suggests that soluble factors released by the MSC are key elements in their mechanism of action for most, if not all, of the systemic effects. MSC secrete stromal derived factor-1 (SDF-1), which plays a critical role in the homing of haematopoietic stem cells to the marrow niche. In vitro, MSCs constitutively secrete several interleukins, macrophage colony-stimulating factor (M-CSF), Flt-3 ligand and stem cell factor. Upon IL-1α stimulation, MSC are induced to express further IL-1α, leukemia inhibitory factory (LIF), granulocyte-colony stimulating factor (G-CSF) and granulocyte macrophage colony-stimulating factor (GM-CSF) and several chemokine ligands. MSCs are also thought to secrete biochemical mediators unrelated to the lymphohematopoietic system like the brain-derived neurotropic factor (BDNF) and nerve growth factor (β-NGF). Currently, the search for indescribed mediators generated by MSCs from several non-traditional sources like placenta, umbilical cord, fat tissue and so on is an active area of investigation and will probably reveal a new array of important signaling secreted molecules. The isolation, culture expansion conditions and the tissue source of stem cells may significantly affect gene expression and therefore the bioactivity of the cells. Such conditions include the seeding density, culture media, serum supplementation, extent of ex vivo expansion etc. Furthermore, bioreactors in contrast to conventional plastic culture flasks may affect gene expression. These observations suggest that the cell-processing protocols can modify expression of specific genes to optimize the cytokine profile for a given clinical indication. Observations so far These observations suggest a new paradigm for the therapeutic application of MSCs. Systemically infused MSC exert a therapeutic effect primarily through the release of soluble mediators that act on local and possibly distant target tissues. Rather than serving as stem cells to repair tissues, they serve as cellular factories secreting mediators to stimulate the repair of tissues or modulate the local microenvironment to foster requisite beneficial effects. In the future, the lack of human leukocyte antigen (HLA) expression in certain MSC types may also allow allogenic usage applications. MSCs can also serve as progenitors. For local therapy, such as in spinal cord injury, non-healing fractures etc. MSCs seem to differentiate into nerve, bone and muscle tissue to foster healing. They have also been reported to reduce the risk of graft failure after haplo-identical transplant.  Similarly, pre-clinical models of MSC-based cell therapy for acute myocardial infarction, neuronal disease, injury such as stroke and autoimmune disorders appear very promising. Summary Secretion of soluble mediators seems to be the predominant mechanism of action of MSCs. We must demonstrate precise processing protocols that could generate populations of MSC especially suited for specific clinical indications from specific sources. Another intriguing prospect for the future is the use of MSCs to create ‘off-the-shelf’ MSC banks. To fully harness the potential of these cells, future studies should be directed to ascertain their cellular and molecular characteristics for optimal identification, isolation and expansion, and to understand the natural, endogenous role(s) of MSCs in normal and abnormal tissue functions. In this way, we will continue to move the field forward and, hopefully, the promise of MSCs to address unmet medical needs can be fully realized. ]]> <![CDATA[Jai Ho Biotech!]]> https://biospectrumindia.com/news/95/2992/jai-ho-biotech.html https://biospectrumindia.com/news/95/2992/jai-ho-biotech.html Tue, 10 Mar 2009 16:54:00 +0530 Jai Ho Biotech! When the first human genetic map was unveiled in the year 2000, the global collaborative project cost approximately $3 billion. Two years ago, when the full genome of the iconic scientist, James Watson was published in full, the project cost just a tenth or around $300 million. Now there are companies in California offering to provide an individual’s gene map for just about $1,000. And the latest issue  of Technology Review, from MIT, has predicted that the individual genome map could soon be available for as little as $100. This is the progress biotechnology is making with the adoption of some cutting edge technological tools. Many of these developments are possible mainly due to advances on computer software, electronic instrumentation, imaging, and host of other enabling technologies. So this 6th Anniversary Special Issue of BioSpectrum has attempted to highlight some of these enabling technologies without which biotech would not be what it is today. In fact sequencing technologies have enabled the mapping of human genome and understanding of molecular mechanisms of life much better. Gene sequencer as a technology has remained central to modern molecular research. PCR emerged as the most revolutionary technique that accelerated biotech research allowing detection of genetic mutations as well as analyzing degraded DNA, among other things. Similarly DNA microarray is a prime technology for the analysis of performance of gene expression. Chromatography and mass spectrometry are the most preferred techniques for routine bio analysis and are commonly used in pharmacokinetic studies. With the development and maturing of other technologies like the flow cytometry and LIMS, biotechnology is being harnessed much better now. And biotechnology is moving into the next horizon of managing the life in general and life sciences industry in particular. It promises hope for treatment of Alzheimer’s; promises stem cells therapies; new ways of managing life style diseases like obesity and insulin; gene therapy using purified preparations of a gene or a fraction of a gene to treat diseases; and new therapies for neurodegenerative disorders like the neuron replacement therapy. Certainly the expectations run high on the healthcare arena. While new therapies are being discovered, the use of biotechnology as an alternative to conventional fuel cells etc. is on. Genetic testing is a new way of diagnosis. In another five years time genome analysis of an individual would be available for lesser than Rs 1,000 and as common as mobile phone technology. The Technology Review’s 10 Emerging Technologies list also has other interesting developments in areas such as clean energy, health care, computing and communications. The promising ones include some medical technologies such as paper-based medical tests, biological machines and $100 genome analysis chip. These developments are good news to the sector. Are there any other major technological developments that will guide the progress in biotechnology? BioSpectrum has put together a list of 12  developments that would make a difference to the life sciences industry in general. The thin line between the pharmaceutical industry and biotech segment is now narrowing further. The developments at Pfizer, Roche, etc. are an indication to this effect. And the industry has the opportunity to embrace the challenges posed by the current financial downturn and transform its way of conducting business and research. Operational excellence as a strategy is the mantra. <sureshn@cybermedia.co.in> ]]> <![CDATA[BioAsia 2009 Bringing Business When it Matters]]> https://biospectrumindia.com/news/95/2316/bioasia-2009-bringing-business-when-it-matters.html https://biospectrumindia.com/news/95/2316/bioasia-2009-bringing-business-when-it-matters.html Tue, 10 Mar 2009 16:49:00 +0530 BioAsia 2009 Bringing Business When it Matters There are times when recession forces companies to rethink their investment plans, slash people and suspend many ongoing projects. However the mood in air at the recently concluded BioAsia 2009, a three-day life science business conference in Hyderabad, India, was more of a joyous feeling. Talks of recession and declining sales made rounds, however, people were optimistic that businesses will rebound soon— as soon as six months. Jointly organized by the Federation of Asian Biotech Associations (FABA), State Government of Andhra Pradesh (where Hyderabad is located), University of Hyderabad, and All India Biotech Association (AIBA), the event, which is in its sixth year, saw the participation of over 3,000 people. There were about 30 companies from the US, Singapore, India, Iran and Spain participated in the event. Spain (Catalonia region), Sri Lanka and Iran were the biggest foreign delegation who had come to the event to sell their countries as an ideal location for biotechnology business and also solicit business interests in their respective countries Some of the top biotechnology and pharmaceutical companies such as Lonza and Shantha Biotechnics have participated in the event. BioAsia, one of the largest biotech and life sciences event in South Asia, provided a platform for local and multinational companies to network, display their products and technologies, and interact with the delegates. There were two tracks and 17 sessions with about 72 speakers. Parallel agri sessions were also there on all the three days with about 25 speakers in eight sessions. The sessions were well appreciated by the participants. A number of students were also seen gathered in each session. Pre-inauguration, there was a visit to the bio-park located in the Genome Valley in Hyderabad. The park, one of the largest in Asia, offers plug-and-play facilities for biotechnology companies. “Besides the conference, there were a number of B2B meetings held. Total number of meeting held in three days was 280, while there were 665 meeting requests sent before the event started and of these, 290 requests for meetings are pending,” said Momme Christian Velmede of PharmABC, a Germany-based life sciences B2B meetings consultant. Last year there were just 70 meetings. A 300 percent increase in the B2B meetings this year is quite remarkable. At a time when the global life science story is not very encouraging, the number of visitors and companies participated in the event shows that biotechnology hasn’t lost its gravy train. The next edition of BioAsia will be held in Hyderabad from February 3-6, 2010. Awards of Excellence During the Inaugural Session of BioAsia 2009, Dr. Y S Rajasekhara Reddy, Chief Minister of Andhra Pradesh conferred the Genome Valley Excellence Award 2009 to two eminent personalities in the field of biotechnology. He also presented BioAsia Innovation Award, BioAsia Young Minds Award, and Best Stall Award. Genome Valley Excellence Award   1. Prof. Marc Van Montagu, founder and chairman, Institute of Plant Biotechnology for Developing Countries, Belgium. The following endeavors helped Dr. Montagu to win this award:   Discovering the gene transfer mechanism between agrobacterium and plants.  Developing plant molecular mechanisms for cell proliferation, and differentiation and response to abiotic stresses.  Constructing transgenic crops resistant to insect pest and tolerant to novel herbicides. 2. Dr. Martin Mackay, president, Pfizer Global Research and Development (PGRD), US. The award winning activities of Dr. Mackay are: His pivotal role in forming the world’s largest private biomedical research organization comprising over 13,000 employees. His stewardship role in increasing the number of Pfizer biotechnology products from a single compound to over 25 in the last decade. Establishing ‘Asia Pharma R&D Function’. BioAsia Innovation Award Dr. Sunil Kumar Verma, scientist, Center for Cellular and Molecular Biology (CCMB), Hyderabad, for novel universal technique to establish the identity of enormous number of animal species for forensic application. BioAsia Young Minds Award B Abinaya, 11th standard student, Sri Sankara Senior Secondary School, Chennai, for a project work on marine actinomycetes. Stall Awards Winner: Vibha Seeds, Hyderabad, India First runner-up: Lonza, Switzerland Second runner-up: Matrix, Hyderabad, India. Sanjeev Jain in Hyderabad ]]> <![CDATA[Mitigating Technology Challenges in Life Sciences R&D]]> https://biospectrumindia.com/news/95/1668/mitigating-technology-challenges-in-life-sciences-rd.html https://biospectrumindia.com/news/95/1668/mitigating-technology-challenges-in-life-sciences-rd.html Tue, 10 Mar 2009 16:43:00 +0530 Mitigating Technology Challenges in Life Sciences R&D -Supreet Deshpande, CEO, VLife Sciences Technologies Pvt Ltd Two hundred years ago a man was born whose work on evolution changed the way we looked at our environment. Charles Darwin’s book the “Origin of Species” proposed a process by which the amazing diversity that exists in nature has come by. That book proved to be a profound turning point for not only the scientific community of that time but to the general populace as well. Today we are experiencing a similar profound event. Deciphering of the genome sequences of many life forms and advancements in proteomics have been the definitive events in life sciences of our times. This progress combined with that made in the fields of engineered tissue systems and stem cells has since raised the expectations for miracle cures for many of the debilitating diseases afflicting humankind today. Unrealistic expectations more often than not undermine the promises held out by modern technology. The technologies in the life science R&D space are no exception. This is compounded by the uneven development of technology that goes into the drug discovery process, which forms an important component of the life sciences. Simply put, the technology evolution in some aspects of this process has not kept pace with that in other aspects. For instance highly advanced technologies are today available for the discovery, design and optimization of lead compounds for tomorrow’s drugs. However the further refinement and eligibility of these candidates is still dependent on lengthy and expensive in vitro and in vivo testing processes. These processes remain time consuming and hence limit the time and cost savings brought to the new drug development process by cutting edge discovery technologies. The benefits accruing out of using computational tools for drug candidate discovery and optimization are well understood and recognized. Such technologies enable a manifold expansion of the initial chemical exploration space, which is not feasible in a time and cost intensive laboratory-centric effort. They help the development of a robust molecule design criteria taking cognizance of the characteristics of the target protein and information of known active compounds against that protein from historical research. They enable multiple ‘what if’ scenario try-outs before even entering a laboratory. They allow pursuit of a structure-based research program even when the three dimensional protein structure is not available. Finally, they enable virtual screening of a chemical space on various aspects thus preempting later stage failures on account of efficacy, toxicity and bio-availability. Usage of such technologies has effectively halved the time required to take a compound from the drawing board stage to the pre-clinical stage. Absence of proven technologies for the subsequent stages has more or less left the time lines for those stages intact. The need of the hour is the development of robust technologies that could quickly replace the time intensive laboratory experimentation phases. A wish list for such technologies would not be complete without inclusion of simulation models for cell level studies, organ level studies and whole animal studies. A complete replacement of in vitro and in vivo testing with computational simulation will of course be another example of unrealistic expectations but development of models that can contribute towards minimizing such testing would definitely be in the realm of today’s technology. Fortunately, there are an increasing number of technology and domain experts who are putting their collective skills in developing such models but it would perhaps take a more concerted and focused effort from the scientific and technology thought leaders before such models could become available for regular use in the drug development process. Mere availability of computational technology cannot in any way ensure a rapid R&D process. In fact, the efficacy of a discovery research program significantly depends on three factors. The first factor is the selection of the right technology, second is knowledge of the researcher about the limitations and strengths of the technology and the third and most important factor is establishing correct expectations from the technology, which has significant impact on the correct ‘go–no go’ decisions. This brings to fore the second challenge facing the life science sector today; that of availability of skilled resources that can effectively leverage the power of technology. Significant investments will have to be made in training the implementers of these technologies to realize its true potential. A multitude of training centers have mushroomed in large and small cities of the country offering training in various bioinformatics tools. Although a laudable initiative in itself, better results from such effort could be ensured if the quality of training imparted has an oversight and guidance from an appropriate accreditation body. Development of technologies to cover a bigger spectrum of activities in the life sciences R&D and training of resources on these technologies would go a long way in offsetting the challenges posed by modern times. ]]> <![CDATA[Flow Cytometry, Simplifying Cell Selection Task]]> https://biospectrumindia.com/news/95/2912/flow-cytometry-simplifying-cell-selection-task.html https://biospectrumindia.com/news/95/2912/flow-cytometry-simplifying-cell-selection-task.html Tue, 10 Mar 2009 16:02:00 +0530 Flow Cytometry, Simplifying Cell Selection Task Since its invention, flow cytometry has enabled scientists to analyze a variety of cell types. Today, the applications of this technology are even broader and powerful. Flow cytometry is a technique for counting, examining and sorting microscopic particles suspended in a stream of fluid. It allows simultaneous multiparametric analysis of the physical and chemical characteristics of single cells flowing through an optical and/or electronic detection apparatus. Early flow cytometers were generally experimental devices, but recent technological advances have created a considerable market for the instrumentation, as well as the reagents used in analysis, such as fluorescently-labeled antibodies and analysis software. Modern flow cytometers are capable of analyzing several thousand particles every second, in real time, and can actively separate and isolate particles having specified properties.  The new flow cytometers usually have multiple lasers and fluorescence detectors. Increasing the number of lasers and detectors allow multiple antibody labeling and can more precisely identify a target population by their phenotype. Certain instruments can even take digital images of individual cells and allow analysis of fluorescent signal location within or on the surface of cells. Fluorescence-Activated Cell Sorting (FACS) has emerged as a specialized type of flow cytometry. It provides a method for sorting a heterogeneous mixture of biological cells into two or more containers based upon the specific light scattering and fluorescent characteristics of each cell. It has become a useful scientific instrument as it provides fast, objective and quantitative recording of fluorescent signals from individual cells as well as physical separation of cells of particular interest. The acronym FACS is trademarked and owned by Becton Dickinson. The invention The first fluorescence-based flow cytometry device (ICP 11) was developed in the year 1968 by Wolfgang Göhde from the University of Münster, Germany (patent no. DE1815352) and first commercialized in 1968-69 by German developer and manufacturer Partec through Phywe AG in Göttingen. At that time absorption methods were still widely favored by other scientists over fluorescence methods. The original name of the flow cytometry technology was pulse cytophotometry. After 10 years, in 1978, at the conference of the American engineering foundation in Pensacola, Florida, the name was changed to flow cytometry, a term which quickly became popular. Subsequently Bio/Physics Systems Inc. introduced flow cytometry instrument named Cytofluorograph in 1971. In 1973 Partec introduced  PAS 8000. The first FACS instrument from Becton Dickinson came in 1974. ICP 22 from Partec/Phywe and Epics from Coulter were introduced in 1975 and 1977-78 respectively. Widening applications The use of flow cytometry has increased considerably during the past decade. The technology has enabled the rapid measurement and analysis of multiple characteristics of single cells. Flow cytometric DNA has been found valuable in determining the biological behavior of various tumors and predicting clinical outcomes. The technology has applications in a number of fields, including molecular biology, pathology, immunology, plant biology and marine biology. In the field of molecular biology it is especially useful when used with fluorescence tagged antibodies. It has broad application in medicine especially in transplantation, hematology, tumor immunology and chemotherapy, genetics and sperm sorting for sex preselection. In marine biology, the auto-fluorescent properties of photosynthetic plankton can be exploited by flow cytometry in order to characterize abundance and community structure. In protein engineering, flow cytometry is used in conjunction with yeast display and bacterial display to identify cell surface-displayed protein variants with desired properties. Ram Sharma, managing director, BD, said, “We never imagined that flow cytometry will become core for monitoring CD4. This is now the most preferred solution for monitoring HIV/AIDS patients. Almost 90 percent of all CD4 monitoring is done using our flow cytometry. Although the technology already has a lot of clinical applications in monitoring cancer, HIV, cord blood banking, and stem cells, it has not been intensely deployed in the areas of drug discovery, life science research and basic research. Through partnerships with research institutes, we can increase the scope of our products in the life science research applications. Our primary aim lies in enhancing our scope in drug discovery.” Market overview Compared to other technologies, there are few players operating in the flow cytometry market space, the important ones being Beckman Coulter, Guava Technologies, Luminex and Dako which are offering products in India and globally. Talking about market competition, Rama Sharma of BD said, “Over a period of time, the technology becomes less competitive. The real difference is the quality of people who are training and educating the customers and the support that you provide to your customers. The manufacturers have to keep a constant check on the efficiency of the systems and probability of new applications for investment.” The flow cytometry market is composed of instruments, reagents, devices, and services used across the research and clinical life sciences areas that span the academic and biomedical, biotechnology, and pharmaceutical business market sectors. According to a market research report, the global flow cytometry market in 2008 stood at $1.5 billion and is estimated to grow to $3.7 billion by 2015 with estimated growth rates of existing product. About 68 percent of the 2008 product revenue has been from instruments, and reagents make up 32 percent of the revenue. Cell-based flow cytometry is estimated at $1.3 billion with a CAGR of 10-15 percent in the coming year. Market leaders Becton Dickinson and Beckman Coulter account for about 70 percent of the research and clinical areas of the cell-based flow cytometry market. Bead-based flow cytometry is estimated at $215 million with a CAGR of 25-30 percent while Luminex and partners comprise approximately 90 percent of the bead-based flow cytometry market. Anticipated developments Researchers expects more fluorescent dyes to become available, with more color options, and also further technical improvements. These include dyes with much higher stoke shifts and alternatives for tandem dyes, which often suffer from inherent problems in multi-laser applications. Upgradation of some existing dyes are in the pipeline, which will offer increased brightness for conjugated antibodies. It is also predicted that new dyes will be offered together with new laser options from flow cytometer manufacturers, with an emphasis on accessibility. New solid state lasers in digital instruments are providing options in bench top machines that were previously restricted to top-end instruments. Jahanara Parveen “The Future Belongs to Cell-based Therapies and Flow Cytometry is the Central Tool” -Sunit Trivedi, director, BD Biosciences, BD India How is flow cytometry making a difference to biotechnology research ? The life science research in the last few years has moved from genomics and proteomics to single cell analysis. Flow cytometry’s power of single cell analysis makes this new research possible. Flow cytometry posses the ability to sort cells with absolute precision in terms of purity, recovery and viability. It has the power of measuring everything in the cell including cell surface antigens, membrane proteins, intracellular proteins (cytokines), signal transduction pathways, cell signaling, nuclear proteins, apoptosis, DNA cell cycle, and ploidy analysis and co-relates all these assays to answer critical questions in healthcare such as stem cell enumeration, leukemia and lymphoma phenotyping, and HIV monitoring. The future belongs to cell-based therapies with flow cytometry as its integral part.  “Cytomics” is the combination of cytometry technology with other cell biology and imaging techniques. How has flow cytometry contributed to the development of research ? Flow cytometry has become the central tool. Almost every question can be answered with flow cytometry. This technology  helps to answer questions at single cell level, probe what it is and then understand what it is doing. One can also see the working of a cell and observe how the cell is being affected by a drug. It enables us to identify samples with many flurochromes at the same time. Many colors lead to more answers and more answers lead to more questions. At the end of the day, researchers are getting to a point where they can do an analysis on rare samples and understand much more completely what has happened. If you compare cytometry 20 years ago, with what researchers can do today, you can’t really say enough about what the technology can do and where you can go with it. Researchers can do things that they were never able to do before and that is really because of the speed of computer processing, the availability of new solid state  lasers with more power, more control over the lasers and the size of lasers. Now researchers can do 17 colors simultaneously because the processing speed of computers lets researchers collect the data at that speed. The power, lasers and flexibility let researchers identify large number of cells, using different flurochromes and different areas of spectrum that were previously inaccessible. Flow cytometers  can allow measurements of particles as small as 200nm and it finds applications in marine biology, microbiology, environmental biology, and nanotechnology. Its capability is used in applications such as chlorophyll detection and analysis of sperm cells. Flow cytometry with spectral analyzer capabilities are used in marine biology applications and could be used to measure fluoroscence energy transfer in fluorescent protein pairs. Few of the versions also features special brackets that easily mount the instrument shipboard. Quick- exchange fluidics with single use sort assemblies allow researchers to achieve true aseptic conditions and prevent possible cross-contamination between samples which may lead to therapeutic cell sorting and effective cell therapy using stem cells, a much needed breakthrough required in many incurable diseases. Development in technology has made it possible to build flow cytometers on fixed alignment with flow cell which reduce startup time, improve reproducibility, improve sensitivity  and efficiency. But the most important advantage is ease of use that has upgraded flow cytometry as a user-friendly sorting device which is so often required for cellular researchers. A quick  and intuitive alignment procedure has been designed in the system with pin hole camera to bring near optical alignment within seconds without using beads. Two way and four way sorting can be optimized for applications in genomics and  proteomics. For instance, cells can be deflected according to their DNA content to arrange them by the phase in the cell cycle. While  mRNA hybridization to the stripe of cells of increasing DNA content might serve to study differential gene expression during the cell cycle. Software improvements play a major role in flow cytometry and make researcher’s job easier. Softwares like Cytometer Setup and Tracking (CS&T) automates flow cytometer setup, adjusts instrument variability and establishes baseline settings. Chances of operator error are reduced, and results are more consistent. The setup features let users define a configuration baseline and run a performance check. The software will then automatically set up the cytometer to this established baseline. To match the exact baseline, the CS&T software automatically adjusts reproducible performance of the instrument. This ensures the greatest possible consistency from one day to the next, saves time, and improves reliability of experiment results. The software also allows creation of application-specific settings for rapid performance of routine experiments in a more consistent manner. Instruments can also be customized to meet customer requirements via the Special Order Research Products (SORP) programs taking care of special research needs and configurations. What are some of the advances that you foresee? More dyes will take advantage of larger spectra, moving from visible color spectrum to far infrared to get more information out of a cell. How can flow cytometry technology be further promoted? Education and training are the key. Organizations should open training centers and collaborate with leading institutions to facilitate  training of larger group to maximize versatile utility of flow technology. ]]> <![CDATA[Biofuel Cells, an Alternative to Conventional Fuel Cells]]> https://biospectrumindia.com/news/95/7857/biofuel-cells-an-alternative-to-conventional-fuel-cells.html https://biospectrumindia.com/news/95/7857/biofuel-cells-an-alternative-to-conventional-fuel-cells.html Tue, 10 Mar 2009 15:43:00 +0530 Biofuel Cells, an Alternative to Conventional Fuel Cells Imagine running your cellphone and mp3 player on alcohol, sounds surprising? Biofuel cells will make it a reality in the near future. Here we explore the tremendous possibilities of biofuel cells. In October 2008, Japanese scientists from the Sony Corporation developed a bio-battery that generates electricity from glucose using enzymes as catalysts. When the researchers stacked four of the cells together, they achieved a power output of 100 milliwatts, enough to run an mp3 player or a remote controlled car. Biological fuel cells (biofuel cells) use biocatalysts, which include bio-molecules such as enzymes or even whole living organisms (microbes) to catalyze oxidation of biomass-based materials for generating electrical energy. A typical biofuel cell consists of an anode and a cathode separated by a proton-conducting membrane. A renewable fuel, such as a sugar, is oxidized by microorganisms at the anode, generating electrons and protons. The protons migrate through a membrane to the cathode while the electrons are transferred to the cathode by an external circuit. The electrons and protons combine with oxygen at the cathode to form water. Biofuel cells are highly renewable and capable of using naturally available biomass as fuel, as a result, they are an excellent alternative to conventional fuel cells (and batteries) that are plagued by non-renewability, non-implantability, size/weight, operating conditions (high temperature, acidity and toxicity), waste issues, and logistics. They are able to operate at a low substrate concentration which can be even at the micromolar level. Types of biofuel cells There are a number of biologically-based fuel cell formats: Cells which use a primary fuel (usually an organic waste such as corn husks) and generate a material such as hydrogen, which is then used as a secondary fuel within a conventional hydrogen/oxygen fuel cell. It is to be noted that there is no direct generation of power by biological means here. Cells which generate electricity directly from an organic fuel such as glucose, using either enzymes or complete microorganisms. Cells which combine the utilization of photochemically active systems and biological moieties to harvest the energy from sunlight and convert it into electrical energy. Biofuel cells which directly convert fuel to electricity utilize biological moieties such as enzymes or living cells to directly generate power from the chemical energy contained within various organic or inorganic species. A typical fuel cell of this format has two electrodes separated by a semi-permeable membrane placed in a solution. A biological species such as a microbial cell (E.coli) or enzyme (glucose oxidase) can either be in solution (or as a suspension) within the anodic compartment of the cell—or alternatively be immobilized at the electrode. Once a suitable fuel is introduced, it becomes either partially or totally oxidized at the anode and the electrons released by this process are used to reduce oxygen at the cathode. The presence of mediator compounds such as methylene blue increase the efficiency of the cell. Enzyme-based fuel cells remain as a focus for research due to the high turnover rate and high biocatalysis rate associated with enzymes. The progress in the immobilization of enzymes at electrode surfaces has facilitated efficient electron transfer between the enzyme and the electrode, this indicates that the presence of oxygen in the anodic environment would not affect the bioelectrocatalytic activity of the enzyme and the enzyme-based electrodes could match the performance attainable at platinum electrodes. Photochemical biofuel cells use respiratory fuel as it makes use microbes. For instance, a cell containing biological moieties in both the anode (cyanobacteria) and cathode (bilirubin oxidase) compartments, the cyanobacteria catalyze the photooxidation of water with the production of electrons that are passed to the carbon felt anode and are thereby made available for the reduction of oxygen at the cathode. Future Although there is a huge potential for further improvement, the development of biofuel cells for practical applications is still in its infancy. However, based on their utility, here are some of the areas in which they could find an application. Transport and energy generation: At present fossil fuels are driving the world’s power needs but they pose environmental hazards and also cannot be used indefinitely. The utilization of biofuel cells with carbohydrates as a power source would, if they could be developed, help to mitigate at least some of these problems. It has been calculated  that a liter of concentrated carbohydrate solution could power a car for 25–30 km. If a car running on concentrated carbohydrate solution is fitted with a 50 liter tank, it could travel over 1,000 km without refueling. Implantable power sources: Biofuel cells can potentially be run in living systems, since the oxygen and fuel required for their operation can be taken from their immediate environment and this offers great potential as power sources for implantable medical devices. For example, a biosensor for glucose has been developed to give a measurement of the glucose concentration in the range of 1–80 mM. A similar sensor for lactate has also been developed. Biofuel cells can be used in pacemakers, catheters, defibrillators, active delivery devices (insulin pumps etc.), drug delivery systems, middle ear hearing devices, and more. Ideally an implanted biofuel cell would use a biological metabolite fuel source such as glucose or lactate, both of which are readily available in physiological fluids such as blood. Wastewater treatment Numerous fuel cells have been shown to generate power by oxidation of compounds found in wastewater streams. This could help in the removal of organic compounds from the waste stream for the generation of electrical power. The most relevant application involves the use of a biofuel cell to trickle-charge lithium-ion batteries used in consumer electronics such as cell phones, laptops and PDAs. They could be used as power sources for environmental sensors, pollution monitors, wildlife tracking sensors, crop quality control sensors etc. Biofuel cell will also enhances power supplies in remote areas as readily available fuel sources such as  plant saps with high levels of sugars could be used as a fuel. Although some specialist devices like short lifetime implantable power devices could now be considered feasible. There is a need for a continuous research effort to see large scale use of biofuel cells. Shalini Gupta ]]> <![CDATA[RNAi Therapy, Enhancing Therapeutic Treatments]]> https://biospectrumindia.com/news/95/1601/rnai-therapy-enhancing-therapeutic-treatments.html https://biospectrumindia.com/news/95/1601/rnai-therapy-enhancing-therapeutic-treatments.html Tue, 10 Mar 2009 15:38:00 +0530 RNAi Therapy, Enhancing  Therapeutic Treatments Discovered in 1998 by Craig Mello and Andrew Fire, RNA interference is heralded as a major scientific breakthrough in the past decade and was awarded the Nobel Prize for Physiology or Medicine in 2006. Also known as gene silencing RNA interference  involves the use of double stranded RNA (dsRNA). Once inside the cell, this material is processed into short 21-26 nucleotide RNAs termed siRNAs that are used in a sequence-specific manner to recognize and destroy complementary RNA, effectively switching off the activity of the gene and halting production of the protein for which it codes. This activity is being developed as a potential antiviral therapeutic strategy. However, therapeutic strategies using RNAi against viruses that cause chronic infections, such as human immuno deficiency virus (HIV) and hepatitis B or hepatitis C, are more difficult to design, but studies have begun to address identifiable problems. Developments and history RNAi technologies include chemical synthesis by in vitro transcription and use of plasmid or viral vectors. DNA-directed RNAi (ddRNAi) is used to produce dsRNA inside the cell, which is cleaved into siRNA by the action of Dicer, a specific type of RNAse III. MicroRNAs are derived by processing  short hairpins that can inhibit the mRNAs. Expressed interfering RNA (eiRNA) is used to express dsRNA intracellularly from DNA plasmids. Since its discovery, many companies have started to develop therapies based on the Nobel Prize winning RNAi technology and Alnylam Pharmaceuticals is spearheading the business of RNAi-based therapeutics. The company has to its credit the maximum number of collaborations and has received maximum funding in the RNAi segment.  It currently has one product, ALN-RSV01, in clinical development, which is in phase-II trials for respiratory syncytial virus (RSV). In addition, the company is developing RNAi therapeutics for the treatment of influenza, hypercholesterolemia, and liver cancers, among other diseases. The company teamed up with Isis Pharmaceuticals to form Regulus Therapeutics, a company focused on developing new drugs based on microRNA. MicroRNA is one of two types of RNA interference found in all human cells and affects how genes are turned off and on. MiRNAs regulate whole network of genes; therefore therapeutics based on this technology represent a new approach to target the pathways of disease. SR Pharma subsidiary Atugen developed RTP-801i and later licensed it to Quark Biotech. The drug prevents the functioning  of the gene REDD-1 that is linked to the progression of wet age-related macular degeneration (AMD) where aberrant blood vessels beneath the retina leak blood and fluid into the eye causing loss of vision. In April 2008, GlaxoSmithKline and Regulus Therapeutics announced a $600 million alliance to discover, develop and market microRNA-targeted therapeutics to treat inflammatory diseases such as rheumatoid arthritis and inflammatory bowel disease. Calando Pharmaceuticals, a majority-owned subsidiary of Arrowhead Research Corporation based in California, US, has its lead candidate, CALAA-01, in phase-I clinical trials, the results of which are expected in 2010. The drug is a nanoparticle that contains small interfering RNA (siRNA) that targets the M2 subunit of ribonucleotide reductase, a well-established cancer target. Its nearest competitor in the field of cancer therapies based on RNAi is Silence Therapeutics. A subsidiary of Silence, called Atugen, along with partners Quark Biotech and Pfizer is currently investigating a siRNA therapy for wet AMD. RTP-801i is currently in phase-I clinical trials. There are no marketed siRNA drugs, RTP-801i is indeed the fourth to enter clinical trials. Sirna Therapeutics was the first company to take a siRNA drug into trials. It had two drug candidates in clinical development, which include one that also treated AMD, when Merck & Co recently bought it in a deal worth $1.1 billion. Merck & Co has also, in the past, signed collaboration deals with SR Pharma and Alnylam Pharma. Sirna Therapeutics was the first company to take a siRNA drug into trials. It had two drug candidates in clinical development, one for AMD and one for hepatitis C, when Merck & Co bought it this year, in a deal worth $1.1 billion. Opko was formed when Acuity Pharmaceuticals an Froptix Corporation merged in March 2007 has the most advanced siRNA therapy, this time to treat AMD and diabetic macular edema (DME), bevasiranib has completed phase-II trials. Biotech company Nucleonics has recently been cleared by the FDA to begin a phase-I trial of its RNAi based therapy for hepatitis B. Slightly different to the others, this therapy uses strands of DNA which, once in the body, produce siRNA and is dubbed expressed interfering RNA (eiRNA). An Australian company called Benitec has a drug designed to target HIV/AIDS, is in phase-I clinical development. Future RNA interference continues to offer significant promise for a host of therapeutic treatments. Potentially any disease-causing gene, cell type or tissue can be targeted with RNAi, including those not ‘druggable’ with small molecules or protein-based therapies. Pharma companies are increasingly investing in siRNA optimization or examining siRNA alternatives, in addition to staking out proprietary positions in lipid-based, nanotransporter-based and alternative delivery technologies. The development and licensing of such platforms will become crucial for developers over the coming years. Although several researchers have tried to develop the therapeutic potential of RNA interference  technology, the limited success of various delivery methods such as viral mediated delivery and intravenous injection hampered its wider application. Being based on natural molecules, RNAi drugs hold a number of advantages over traditional drugs, both small molecules and biopharmaceuticals. RNAi drugs can eliminate years of screening and the drug candidates can get into the clinic very quickly. Not only does this save money, but it could also extend the patent life of the drug while it’s actually in the market. The drugs also don’t need to be stabilized like many other therapies based on RNA molecules. Further research and subsequent clinical trials directed at finding safe and effective in vivo delivery methods for therapeutic siRNAs will be crucial. Jahanara Parveen ]]> <![CDATA[Neural stem cells, Redefining Therapy]]> https://biospectrumindia.com/news/95/5014/neural-stem-cells-redefining-therapy.html https://biospectrumindia.com/news/95/5014/neural-stem-cells-redefining-therapy.html Tue, 10 Mar 2009 15:38:00 +0530 Neural stem cells, Redefining Therapy   Neurodegenerative disorders might get a permanent cure with the help of rapid progress in the neuron replacement therapy. In the early 1990s, researchers revealed that the embryonic nerve cells injected into brain can migrate throughout the organ, grow into healthy replacement cells, and help to reverse brain damage thus leading to treatments for multiple sclerosis and other devastating diseases of the central nervous system. In the embryo, brain cells are thought to develop from unspecialized cells called neural stem cells(NSC). Considering NSCs ability to differentiate into a wide range of cell types, researchers are trying to use them to replace brain cells that are damaged by injury or disease. Research and development Researchers from the Harvard Stem Cell Institute(HSCI) and Columbia University took the development further by demonstrating that the pluripotent stem cells derived from a patient with amyotrophic lateral sclerosis(ALS) can be differentiated into motor neurons, the brain cells that are destroyed by ALS, the fatal neurodegenerative disease, also known as Lou Gehrig’s disease. The researchers believe that if they can figure out how a person’s motor neurons die, they can able to figure out the ways to save that person. Scientists believe that stem cells are the valuable tools to understand the disease process and create mini-representations of disease or assays for the purpose of drug screening. This could further help to examine cellular and molecular defects in motor neurons and glial cells derived from patients with ALS. Neural cells derived from human embryonic stem cells are found to repair stroke-related damage in the brains of rats and led to improvement in their physical abilities after a stroke. The research team led by Gary Steinberg hints that the study is small and more work is needed to determine whether a similar approach would work in humans, the study also shows the potential of stem cell therapies in treating strokes. Human embryonic stem cells possess the ability to transform into any cell type in the body. Pushing embryonic stem cells to form neural stem cells and  eliminating its possibility to form tumors when transplanted remain as the main hurdles. Embryonic stem cells are still immature and retain the ability to renew themselves and produce all tissue types, they tend to grow uncontrollably to become  tumors consisting of a mass of different cells. Researchers overcame this hurdle by growing the embryonic stem cells in a combination of growth hormones that nudged the cells to mature into stable neural stem cells. After six months in a lab dish, those neural stem cells continued to form only the three families of neural cells, neurons, astrocytes and oligodendrocytes. After ensuring the safety of neural cells, Daadi and co-author Anne-Lise Maag, a former research assistant, transplanted those cells into the brains of 10 rats with an induced form of stroke. At the end of two months, the cells had migrated to the damaged brain region and incorporated into the surrounding tissue. None of those transplanted cells formed tumors. Once in place, the transplanted cells helped to repair damage from the induced stroke. The researchers mimicked a stroke in a region of the brain that left one forelimb weak, this model parallels the kind of difficulties people experience after a stroke. Test conducted at fourth and eighth weeks after the stem cell transplants showed that the animals were able to use their forelimbs more effectively than rats with similarly damaged brain regions that had not received the transplants. Before testing this neural cells in humans, researchers are trying to ensure the effectiveness of this approach in animal stroke models. Future The past few years have seen major development in the field of NSC research with more emphasis towards its application in cell replacement therapy for neurological disorders. However, the clinical application of NSCs will remain largely unfeasible until a comprehensive understanding of the cellular and molecular mechanisms of NSC fate specification is achieved. This understanding will increase the possibility to exploit the potential of stem cells in order to manufacture transplantable NSCs that can able to provide a safe and effective therapy for previously untreatable neurological disorders. Since the pathology of each of these disorders is determined by the loss or damage of a specific neural cell population, it is necessary to generate a range of NSCs that can replace specific neurons or glia rather than generating a generic NSC population. In the future, scientists may be able to implant the stem cells directly into patient’s brains to improve mental illness. Contrary to past dogma, scientists have discovered that the brain is continually creating new neurons (neurogenesis) in the hippocampus, an area of the brain critical for long term memory. Depression has been associated with reduced neurogenesis in the hippocampus and antidepressant drugs have the ability to increase neurogenesis. Using the new deep transcranial magnetic stimulation (TMS) may allow researchers to selectively target the hippocampus with electrical stimulation so as to increase the brain’s natural mechanism of generating new neurons. With a more sophisticated understanding of the brain, scientists may be able to achieve neurogenesis in brain areas not normally associated with new neuron growth. Researchers have already devised techniques to guide the position of neurons in the brain. They have incorporated iron particles into single neurons created from stem cells. Using targeted magnetic pulses to precisely position these newly created neurons in specific brain areas to improve several conditions. So science will most likely progress to a better and more controlled creation of new neurons and the precise placement of those neurons into the requisite brain areas. For extreme life extension, replacing aging neurons may be necessary from time to time. In the future, we may be able to use these techniques to periodically replace dying neurons with new ones. Intelligence enhancement is another area that stem cells may have some value in the future. Scientists may be able to increase the amount of neurons in an individual’s brain in areas that are associated with certain performance tasks, such as memory, general intelligence and attention. Overall, we can expect exciting developments in neuron replacement therapy that could improve many currently devastating health conditions and potentially enhance normal people’s functioning as well. Shalini Gupta ]]> <![CDATA[Combination Vaccines Boost Immunization]]> https://biospectrumindia.com/news/95/2315/combination-vaccines-boost-immunization.html https://biospectrumindia.com/news/95/2315/combination-vaccines-boost-immunization.html Tue, 10 Mar 2009 15:21:00 +0530 Combination Vaccines Boost Immunization -Dr. Satish D Ravetkar, senior director, Serum Institute The Greeks had two Gods of health, Aesculapius and Hygieia, meaning therapy and prevention respectively. From ancient days to twentieth century, medicine is revolving around these two points. Vaccines belong mainly to second category proving the proverb ‘prevention is far better than cure’. Like any other discipline in vaccinology, which continuously kept developing, more novel vaccines posed substantial economic, social and logistics issues. Major breakthrough Providing the vaccines as separate injection is not only expensive but also leading to distressed parents and providers. The shipment cost of vaccines coupled with cold storage and administration cost many a times exceeds the cost of vaccine itself. The entire success of immunization program can be jeopardized with missed vaccination schedules. With the acute need for right spacing between two vaccine injections and the need for booster, even best vaccine fails in field.  All these complex issues are resolved by using combination vaccines. Even though the first combination vaccine licensed in the US was approved in November 1945, the combination vaccine concept has caught up in the last decade with the dramatic consolidation in vaccine development; one of the peculiar situation during this period was newer vaccines were  developed and mainly at affordable cost by developing world. More need was felt to revisit the concept of combination vaccine to innovate further. A combination vaccine as name suggests consists of two or more separate antigens  that have been physically combined in a single preparation. One must remember to differentiate between simultaneous vaccines which are administered concurrently but are physically separated.  In fact this very concept partly gave stimuli for the development of more combined vaccines. Issues There are however lot of issues in production of combined vaccines. Chemical or physical interactions among the vaccine components being combined can result in alteration of immune response to different antigens mixed together.  The factors like type of gel suitable for individual antigen or no gel required can also alter the immune response to antigens being mixed together.  In addition to this buffers, excipients and salts, which are good for one antigen can be harmful in terms of immunogenicity of other antigen. Circumventing all these issues to produce effective combination vaccine is real challenge to modern vaccinologist. In spite of this the world vaccine market is having lot of combination vaccines like DtaP/IPV, Tdap/IPV, DtaP/Hib, DtaP/IPV/Hib, DtaP/HepB/IPV, DtaP/HepB/IPV/Hib, HepB/HepA, HepA/Typhoid, Mnc/Hib, DtaP/Hib, DtaP/Hep/IPV, HepB/Hib, DT/IPV, Td/IPV, DtaP/IPV, DtaP/IPV/Hib, DTwP/IPV, DTwP/Hib, DTwP/HepB, DTwP/HepB/Hib, DTwP/IPV/Hib and list continues to grow. The need for huge investment for the clinical trails pose challenge while developing combination vaccine. More funding for combination vaccine particularly for those being developed in developing countries is essential. The cost of combination vaccine against the cost of individual vaccines and their relation to development cost is very sensitive and critical. It’s also a case many a times that single manufacturer may not have all the antigens being manufactured by himself. In that case consolidation of various manufacturers becomes rule of the industry, which luckily seems to be working well.  This synergy is also benefiting in terms of exchange of knowledge between various companies. Combination vaccine trials should also be prospective, randomized and as fully blinded as possible and should have appropriate and ample control groups.  Number of subjects should also be enough to confirm to Good Clinical Practices (GCP).  Common practice in vaccine industry  is  to  conduct  non-inferiority trials which  provides statistical assurance that the investigational product is not inferior compared to standard product.  The candidate vaccine may also be superior or equivalent but not inferior to the standard product available in the market. Future trend The future trend will be to develop combination vaccines depending on the need of that part of world considering various factors.  By reducing number of injections, combination vaccines help to facilitate immunization against more and more diseases with lesser cost and better coverage, which will certainly benefit mankind. It’s up to international agencies like GAVI, UNICEF, WHO and PATH to have co-ordinated efforts to make these costly vaccines available to developing countries where majority of infant population resides. The opportunities, possibilities and market potential are so encouraging that new players will enter the field to leverage advantage of growing market of combination vaccines. Market potential The market potential for combination vaccine is huge.  In 2007, combination vaccines generated $850 million in revenues.  The combination vaccine are slated to cross $2 billion mark in 2013, which implies annual compound growth of more that 17 percent. ]]> <![CDATA[Insulin Inspires Diabetes Treatment]]> https://biospectrumindia.com/news/95/2547/insulin-inspires-diabetes-treatment.html https://biospectrumindia.com/news/95/2547/insulin-inspires-diabetes-treatment.html Tue, 10 Mar 2009 15:19:00 +0530 Gene Therapy, Enabling Patient-specific Treatment Insulin Inspires Diabetes Treatment With India emerging as the diabetes capital of the world, pharmaceutical companies are racing ahead to grab a piece of the pie with new anti-diabetic drugs Insulin therapy has evolved in the last century from purified bovine or porcine insulin to biosynthetic human insulin to recombinant human insulin and eventually to recombinant insulin analogs as the third generation of human insulin. Indian companies are also putting  in efforts to capture the market amid stiff competition from the established multinational companies such as Novo Nordisk, Eli Lilly and Aventis Pasteur. Wockhardt was the first Indian company to launch the country’s indigenously developed recombinant human insulin under the brand Wosulin. A year later Bangalore-based Biocon Ltd announced the launch of Insugen, the new generation bio-insulin in November 2004.  Shreya Life Sciences, the Indian arm of Moscow-based Shreya Corporation too launched human insulin under the brand name Recosulin in December 2004, exactly a month after the launch of Insugen. Besides Indian companies, Eli Lilly entered the Indian insulin market a decade ago in 1995 with the brand Huminsulin. Before that Novo Nordisk launched its human insulin product and went on to introduce insulin analogs under the brand NovoMix 30, a premixed insulin analogue and NovoRapid, a rapid acting insulin analogue, for the first time in India. In August 2005, Eli Lilly and Company (India) too launched its insulin analogs under the brand Humalog Mix 25, 50. In 2007,  Eli Lilly launched Byetta(exenatide), a drug derived from the saliva of the Gila monster, for the treatment of type 2 diabetes mellitus. Byetta is the first in a new category of medicines known as incretin mimetics, which is approved as adjunctive therapy to improve blood sugar level in patients with type 2 diabetes. The year 2008 saw the launch of a Januvia (sitagliptin) by MSD Pharmaceuticals, the first and only prescription medication in a new class of drugs known as dipeptidyl peptidase-4 inhibitors (DPP-4 inhibitors), which enhance the body’s own ability to lower blood sugar when it is elevated.  Very recently Wockhardt has launched a new insulin, Glaritus, a generic version of Sanofi-Aventis’ Lantus, which is a recombinant long-acting human insulin analogue. Glaritus is available as reusable and disposable pen delivery device, which is one of the most preferred modes of insulin injection across the globe today. In a major breakthrough, Mumbai-based Shreya Life Sciences, in collaboration with the US-based Generex Biotechnology Corporation, has announced the launch of world’s first buccal insulin spray under the brand name of Oral-Recosulin in India for the treatment of type-1 and type-2 diabetes. Last year has seen two new classes of drugs entering the market, both of which work on the incretin system, injectable glucagon-like peptide-1 (GLP-1) agonists and oral dipeptidyl peptidase-4 (DPP-4) inhibitors. GLP-1 agonists, also known as incretin mimetics, stimulate insulin secretions from beta cells in the pancreas in response to food intake, in a glucose dependent manner. DPP-4 inhibitors inhibit the DPP-4 enzyme, which results in an increase in circulation of the incretin hormone, GLP-1. Future The worldwide market of the major human insulin products in 2007 was $10 billion. Insulin analogs posted double digit sales growth worldwide due to successive replacement of second generation human insulin. As per ORG IMS, the current market for analogues in India is Rs 120 crore with a growth rate of 37 percent per annum. The Indian diabetic market is estimated to be around $355 million with a growth rate of 20.6 percent as per the ORG IMS. Human insulin market is $107 million with a growth rate of 23.9 percent while the oral antidiabetic market is $248 million and is growing at the rate of 19.2 percent. There are various devices used for delivering insulin, including syringes, pens, pumps, needle-free injectors and inhalers. According to estimates by 2025, nearly one-third of total diabetes patients will be from India and China, both of which have fledgling. The next generations of insulin will be ‘tailored’ insulin, oral insulin and other long-acting insulins for injection with drug delivery solutions, that aims at optimized pharmacokinetic profiles in order to avoid hypo- and hyper-glycemic episodes. After the failure of Pfizer’s inhaled insulin Exubera, most of the R&D efforts are now made on oral insulin products. Mannkind’s Afresa, an inhaled insulin product that has recently completed phase-III trials, and Generex Oral-lyn from Generex Biotechnology, a buccal spray formulation in phase-III in the US has recently been approved for marketing in Ecuador, India and Lebanon. Novo Nordisk plans to launch its anti-diabetes drug Liraglutide in India by 2010, which will treat diabetes faster than insulin. The drug has completed phase-III clinical trials successfully in India. Liraglutide is an analog which has revealed better control of blood sugar compared with insulin therapy in diabetes patients. It reduces hypoglycaemia, the sudden lowering of blood sugar levels, by increasing insulin secretion and delaying gastric emptying. Biocon is developing IN-105, a conjugated insulin molecule that is orally delivered and targeted towards the treatment of diabetes. Biocon’s R&D group has successfully developed a tablet for oral delivery of IN-105, its formulation carefully selected to give consistent absorption and glucodynamic effect. In the clinic, this molecule has completed phase-I trials. The results of the dose range finding of phase-II trials were presented at European Association for the Study of Diabetes (EASD), Rome in September 2008, and the product is expected to hit the market in 2010. Its other product, Nasulin, an intra-nasal insulin spray, is being co-developed with Bentley Pharmaceuticals Inc. and shall also hit the markets the same year.  In the future, insulin may be delivered by implanted or transferral systems. Insulin pumps are already popular in the US, where the small mobile phone-size devices which send a continuous flow of insulin into the body through a hypodermic tip. Implantable insulin pumps are currently under development in Europe and the US. Another future option for insulin administration may be the intranasal route that offers ease of delivery and fast absorption time. In addition, gene therapy and the potential for implanting insulin-producing pancreatic cells are also being researched. With diabetes now the fifth leading cause of death across developed markets and figures from PricewaterhouseCoopers (PwC) suggesting the disease is forecast to grow by 7.1 percent across the globe by 2013, the market for once-a-day drug delivery and non-invasive drug delivery systems continues to offer significant potential for expansion. India is predicted to lead the way with 73.5 million people expected to have the disease by 2025. As such, companies like US-based Eli Lilly by announcing a joint venture with Indian company Jubilant Organisms in October 2008, are looking to secure their place in the market. The next few years promise dramatic change in the treatment of diabetes, much of which will be driven by rapidly developing technology. Every company is striving for two common goals, patient convenience and better control of the disease. History In 1921 Canadian research team led by Dr. Fredrick G Banting discovered insulin extracted from the islets of animal pancreas. Later, bovine insulin was given to humans by injection in 1922. In 1936, protamine, a low-weight protein is used to develop a slow-release insulin. In 1950 yet another approach led to the development of presently available Isophane NPH (Neutral Protamine Hagedorn) insulin, which is also bound to protamine. It was only in 1978, scientists from the biotechnology corporation Genentech in San Francisco, California, used a genetically manipulated plasmid of E. coli bacteria to produce insulin with the same amino sequence as seen in humans. The race to mass produce ‘human’ insulin using gene technology was won by Eli Lilly in 1982 when the Food and Drug Administration (FDA) approved Humulin-R (rapid) and Humulin-N (NPH) for the US market. This was followed by Novo’s semisynthetic insulins, Actrapid HM and Monotard HM. Since 1996, different insulin analogues have been introduced worldwide such as Humalog from Eli Lilly, Lantus and Apidra from Aventis, Levemir and NovoRapid from Novo Nordisk to name a few. Shalini Gupta ]]> <![CDATA[Obesity Management Converges Diverse Approaches]]> https://biospectrumindia.com/news/95/2017/obesity-management-converges-diverse-approaches.html https://biospectrumindia.com/news/95/2017/obesity-management-converges-diverse-approaches.html Tue, 10 Mar 2009 13:43:00 +0530 Obesity Management Converges Diverse Approaches   With exciting fields opening up, obesity management is now being looked upon as a booming market by companies.  It has been denounced as what has been rightly termed as an outbreak of an epidemic called obesity. However, scientists may term it as a losing battle but life sciences companies are cashing on to this challenge as an opportunity considering the huge populace that the “disorder” (as it is supposedly termed) embraces. And why not? The market for obesity drugs by 2012 will look lucrative with the expected populace expected to hit the 600 million mark (with 2 billion slated as overweight) thus opening up whole new vistas. Country-wise, the US is presently the biggest market for weight loss drugs with around 68 percent of its population either overweight or obese. The US is followed by the UK and other European countries. In future, emerging economies, China, Russia, India and Brazil are also expected to become a huge market for weight loss products. With China’s obesity and overweight levels touching 665-670 million by 2015, the country will emerge as the most potential weight loss market. Yet, the million dollar question popping up is will the scientific community and the industry as a whole be able to catch up with this pace? Hopefully yes, if we have a cursory glance at the pipeline of products which are slated to come out in the market by 2015. Evolution and major breakthrough Breakthroughs in obesity are a recent phenomenon and this included the discovery, in 1994, of leptin, a hormone that appeared to provide negative feedback. Later studies showed that appetite regulation is an immensely complex process involving the gastrointestinal tract, many hormones, and both the central and autonomic nervous systems. The phenomenon of obesity was observed much earlier. This was done by studying mutant obese mice that arose at random within a mouse colony at the Jackson Laboratory in 1950.These mice were massively obese and excessively voracious|. Leptin itself was discovered in 1994 by Jeffrey M. Friedman and colleagues at the Rockefeller University through the study of such mice. To date, only leptin and insulin are known to act as an adiposity signal. Although leptin is a circulating signal that reduces appetite, in general, obese people have an unusually high circulating concentration of leptin. These people are said to be resistant to the effects of leptin, in much the same way that people with type 2 diabetes are resistant to the effects of insulin. It was also discovered that the high sustained concentrations of leptin from the enlarged adipose stores result in leptin desensitization. The pathway of leptin control in obese people might be flawed at some point so the body doesn’t adequately receive the satiety feeling subsequently to eating. Early anorectics were fenfluramine and phentermine. A more recent addition is sibutramine which increases serotonin and noradrenaline levels in the central nervous system. In addition, recent reports on recombinant PYY 3-36 suggest that this agent may contribute to weight loss by suppressing appetite. Technological upgradation today The ideal road usually taken as a resort to tackle the issue of obesity is to pitch in for lifestyle modification through diet and exercise and the recent medical intervention being bariatric surgery (applicable as researchers confirm only for morbid obesity). Any eventual drug treatment for overweight and mild obesity is likely to involve combination therapy, i.e., the prescription of two or more drugs, in addition to lifestyle changes, in order for the patient to successfully lose the excess weight and keep it off. Today there is also a huge market for medical devices also mostly from the private sector. Moreover now there have been exciting fields opening up. Early research found that 30 percent of obese people were infected with Ad-36 virus, while only 11 percent of non-obese people were infected. New research finds that Ad-36 has a direct effect on human fat stem cells. The virus infects the fatty tissue and increases replication, differentiation, and accumulation of fat cells. Ultimately, this leads to larger fat cells. The virus also increases lipid sensitivity and decreases leptin secretion of the new fat cells. Moreover it has been argued that obesity cannot just be a consequence of lifestyle disorders and that the existence of some kind of virus may go explain the speed with which the problem has progressed. If proven right then some people may be able to solve some of their weight problems with the application of an anti-viral, or some other treatment that attacks viruses. The past decade has seen tremendous advances in the understanding of the physiological regulation of energy balance and adiposity, and important insights into the pathogenesis of obesity. Today there is a comprehensive view of the adiposity hormone leptin, the subsequent identification of hypothalamic and other brain neuropeptide systems controlling energy balance, and the progress in understanding the molecular mechanisms by which cells can sense and respond to changes in metabolic state. Some of the most recent developments are prototypic compounds that manipulate fat metabolism, both in peripheral tissues and in the brain, to reduce body fat synthesis and storage and to increase fat oxidation, to reduce food intake, and to increase energy expenditure. This apart, with FDA becoming all the more stringent over its guidelines, and drug manufacturers have not been lucky to keep it  in its good books.  Recently the  FDA has published a list of unapproved drugs which it described as “tainted” be pulled off from the market. The list includes rimonabant and sibutramine. Rimonabant was the active ingredient in Zimulti/Acomplia, the ill-fated obesity treatment that Sanofi-Aventis tried to get approved in the US. The FDA turned the application down. Acomplia was marketed for a while in Europe but the European Medicines Authority scrapped off the drug over safety concerns. Sibutramine is the active ingredient in Abbott Labs’ Meridia, a prescription product. However in this case, the USFDA only asserted that the unapproved products that use Meridia as an ingredient  be pulled off rather than the product as a whole being pulled off. The list goes on, as obesity much like Alzheimer’s has been  like walking on a shaky bridge.  The FDA recently also  rejected Orexigen’s Contrave pill because there was not enough difference between the placebo group and patients actually taking the pill. Others include Pfizer which halted its anti-fat drug, the unnamed “CP-945,598,” for “regulatory” reasons, Merck in November pulled its fat pill, taranabant, from its pipeline,GlaxoSmithKline has had disappointing sales from Alli, Roche had negligible sales from Xenical, the Rx version of Alli, Wyeth abandoned fen-phen and Redux after they produced lawsuits. Market potential Realizing the staggering potential in this market, the pharmaceutical sector is very active in research and development for the treatment of overweight, obesity and even morbid obesity. The main goal is to produce a drug or a combination of drugs which results in clinically significant weight loss over placebo, with as less side-effects. More companies have a drug in the pipeline for the treatment of overweight and obesity than for morbid obesity, although a few companies have set their sights on morbid obesity. Some of the medical devices are in the development and testing stages. The world market for clinical management of obesity is forecast to reach about $6.4 billion by 2015, on a revenue compound annual growth rate (CAGR) of 23.2 percent, and a unit CAGR of approximately 19 percent. The prices vary widely between the price for a year of pharmaceutical treatment and the price for the surgically implanted medical devices; the unit price in the table reflects the weighted average based upon the forecasted sales and prices for drugs and devices. The increase in sales is based upon the net effect of a number of factors, including, increasing attention paid by governments, public health systems, physicians and patients to the enormity of the obesity problem and to its growth rate, regulatory approvals and market launch of new, more effective drugs with relatively more acceptable adverse side effects. Despite the repeated failures, pharmaceutical companies and research scientists are not deterred. The recent buzz about obesity equated to an inflectional virus can bring out a revolutionary change for the segment. Though in its animal study phase, if proven on humans, it could probably lead to a paradigm shift in dynamics. The analysis brought out by the Department of Nutrition and Food Science and the Center for Molecular Medicine and Genetics, Wayne State University, Detroit mentions, “Although obesity has multiple etiologies, an overlooked possibility is obesity of an infectious origin. Six pathogens are reported to cause obesity in animals. Canine distemper virus was the first virus reported to cause obesity in mice, followed by Rous-associated virus-7, an avian retrovirus, which has been shown to cause stunting, obesity and hyperlipidemia in chickens. Next, the obesity-promoting effect of Borna disease virus was demonstrated in rats. Scrape agents were reported to induce obesity in mice and hamsters. The final two reports were of SMAM-1, an avian adenovirus, and Ad-36, a human adenovirus that caused obesity in animals. Additionally, an association with human obesity is the unique feature of SMAM-1 and Ad-36. Although the exact mechanism of pathogen-induced obesity is unclear, infection attributable to certain organisms should be included in the long list of potential etiological factors for obesity. In addition, the involvement of some pathogens in etiology of obesity suggests the possibility of a similar role for additional pathogens. If proven this could be a major breakthrough and we can have vaccine products in the future,” added a well known name in the field. Repeated failures in coming up with clinically successful drugs has again not deterred companies from walking the preferably untrodden path. Wyeth will pay $120 million to Thiakis to obtain its anti-obesity drug candidate, TKS1225. In doing so, Wyeth has taken its first, expensive step into a disease category that many drug companies have entered. Galapagos announced that it has entered into a multi-year global strategic alliance with Merck & Co., Inc. to develop potential new therapies in obesity and diabetes. Galapagos will be responsible for the discovery and pre-clinical development of new small molecule candidate drugs based on novel Galapagos targets. Merck will have the exclusive option to license each candidate for clinical development and commercialization on a worldwide basis. The alliance will make use of Galapagos’ proprietary SilenceSelect target discovery platform for identification of novel targets in obesity and diabetes. After validation, targets will be selected by a joint steering committee and entered into screening and chemistry by Galapagos. Merck has the option to acquire an exclusive license to each candidate drug and upon exercise of such an option, Merck will be responsible for the development and commercialization of the candidate drug. Galapagos may execute phase I clinical studies and will have the right to further develop and commercialize certain compounds for which Merck does not exercise its exclusive option. Under the terms of the agreement, Galapagos will receive an upfront fee of EUR 1.5 million from Merck. In addition Galapagos is eligible to receive discovery, development and regulatory milestone payments that could potentially exceed EUR 170 million total for multiple products, as well as specific sales milestones and royalties upon commercialization of any products covered under the agreement. Despite its previous failures and challenges, however, the future potential for obesity drugs is huge with booming pipeline drugs in late phase-II and Phase-III pipelines. With the number of overweight and obese patients expected to reach 2 billion and 600 million respectively by 2012, the opportunity in this market is tremendous. Future trends for obesity The future of obesity treatment and management is moving towards adopting a combination of genomic, surgical and pharmaceutical approaches to manage the disease. While the largely followed bariatric surgery addresses issues with regard to intake of food, an increasing focus is expected around the genetic pathways controlling obesity which would give rise to potential therapeutic targets. For instance, it is a well researched observation that obesity is a complex disease wherein there are strong genetic and environmental factors that impact the penetration and expressivity of obesity. Research so far has indicated high linkage of genes located on five chromosomes including chromosome 2p, 3q, 4p, 5 cen-q,6q,8p,10p,12q,17p,20q and Xq23. The high LOD scores of gene linkages such as those coding for adiponectin,GLUT2 and PI3K,PPAR ALPHA and GLUT-4 indicate the extensive impact of genetics upon obesity. Being interplay of genetic and environmental factors implies that management of obesity would see growth and convergence of three diverse approaches including: Genomics: Advances can be expected around the space of pharmacogenomics and nutrigenomics, wherein treatment for the disease would be based on the drugs suitable for the genomic constitution of the patient and the nutritional content that matches their genomic constitution respectively. Therapeutics: Opportunities to tap the biochemical and genetic pathway of obesity to identify new targets would be the way forward and in that direction, the most promising candidates for obesity therapy to look forward to in the near future include Leptin, GLP-1, extending, Peptide YY 3- 36, NPY and the melanocortin receptor. Source: Bhuvaneashwar S, senior research analyst, technical insights, Healthcare, Frost & Sullivan   Biotech research can make a difference “In the  area of obesity it is only biotech research can make a revolutionary difference. Because all this while, for obesity, the root cause of the disease was not identified and biotech will go to that root cause. This is because obesity is not just caused by lifestyle disorders, it goes beyond that. We will be seeing companies working big time on R&D because there is potential in the market.” Muralidharan Nair, partner, Advisory Services, Ernst & Young Nayantara Som ]]> <![CDATA[Major Breakthroughs in Cancer Therapy]]> https://biospectrumindia.com/news/95/5669/major-breakthroughs-in-cancer-therapy.html https://biospectrumindia.com/news/95/5669/major-breakthroughs-in-cancer-therapy.html Tue, 10 Mar 2009 13:18:00 +0530 Major Breakthroughs in Cancer Therapy -Dr. Ramani A Aiyer, chief scientific officer, Actis Biologics Pvt Ltd. The new millennium has seen tremendous progress in the diagnosis, prognosis and treatment of cancer. Driven by the ‘omics’ revolution along with advances in technologies such as cellular imaging, gene knockouts and other analytical tools, there has been an explosion in knowledge of molecular and cellular pathways, which lead to carcinogenesis and tumor growth. The new millennium has seen tremendous progress in the diagnosis, prognosis and treatment of cancer. Driven by the ‘omics’ revolution (genomics, proteomics, metabolomics) along with advances in technologies such as cellular imaging (e.g., Positron Emission Tomography - PET), gene knockouts and other analytical tools, there has been an explosion in knowledge of molecular and cellular pathways, which lead to carcinogenesis and tumor growth. Much is now known about how the cancer cell lapses into uncontrolled cell proliferation compared to a normal cell. Knowledge has progressed beyond the general notion that genetic mutations cause cancer. Biologists have identified a multitude of targets for diagnosis and therapy in a host of different pathways inside the cell. They include checkpoints in the regulation of the cell cycle, control of apoptosis or programmed cell death and prolongation of cell survival. At the tissue level, the role of angiogenesis or blood vessel formation by tumors has been validated as a key mechanism by which tumors survive in the body. Vascular endothelial growth factors (VEGFs) and their receptors have become clinically validated targets for anti-angiogenesis drugs against cancer. Another set of targets is related to epigenetic changes in cancer cells that cause inactivation of factors that regulate DNA expression, such as tumor suppressor genes, repair proteins and microRNAs. Epigenetic markers include DNA methylation/demethylation and histone modifications, which could be methylation/demethylation or acetylation/deacetylation. Cancer drug therapy has come a long way from traditional chemotherapeutic approaches using non-selective cytotoxic agents. These were generally small molecules (anthracyclines, platinum compounds, nucleoside analogs, nitrosoureas, anti-folate analogs, nitrogen mustards, etc.) that arrest cell division by either inhibiting DNA replication or disrupting microtubules (vinca alkaloids and taxanes). Since these drugs also attacked normal, non-cancerous cells in the body, they caused severe side effects and morbidities such as hair loss, nausea, oral infections, etc. It was clear that in order to mitigate the severe toxicities associated with cytotoxic agents administered systemically they had to be targeted selectively into the cancer cell and away from normal cells.  Several general approaches have been used towards addressing this challenge, but with limited success. They include the use of prodrugs and liposomal formulations to promote selective accumulation of drugs inside tumor cells compared to normal cells, chemo-sensitizing agents and photo-dynamic (light-activated) agents. The key discoveries that lead to significant improvement in the survival of breast and prostate cancer patients are the dependence of breast cancer on the female hormone estrogen and the dependence of prostate cancer on the male hormone testosterone. These findings have lead to the development of hormone-based treatments for these two indications that continue to be the cornerstone of early, effective therapy for breast and prostate cancer. The biotechnology revolution and the development of recombinant DNA therapeutics using cytokines such as interferons and interleukins brought a great deal of promise, but limited success in cancer treatments. Recombinant interferon-alpha-2a (Roferon A, Roche) and interferon-alpha-2b (Intron A, Schering-Plough) have been approved for treatment of several leukemias and other hematological malignancies. Recombinant interleukin-2 (Aldesleukin/Proleukin, Chiron/Novartis) has been approved for melanoma and renal cell carcinoma. The biggest successes of the era were recombinant G-CSF (Filgrastim/Neupogen - Amgen) and GM-CSF (Sargramostim/Leukine – Immunex/Amgen), both capable  of improving white cell count and reversing neutropenia following chemotherapy. The biggest failure of the era was tumor necrosis factor (TNF), which failed to kill any tumor in the clinic and was eventually shown to be one of the key mediators in causing rheumatoid arthritis. Targeted cancer therapies Perhaps the most exciting developments in cancer therapy are the three major breakthroughs that have lead to the successful development of more selective, ‘targeted’ therapies that attack tumor cells, while generally sparing normal cells. The discovery of tumor-specific antigens and receptors over-expressed in certain tumors. The discovery that receptor tyrosine kinase activity plays a central role in tumourigenesis. The discovery of monoclonal antibodies and the ability to tailor-make antibodies directed against specific cell surface antigens. Monoclonal antibodies (MAbs) have revolutionized science, medicine and cancer treatment. Genentech’s Rituxan was the first anti-cancer antibody in the market and several MAb’s have received marketing approval in the US.Dr. Ramani A Aiyer, chief scientific officer, Actis Biologics Pvt Ltd. Targeted therapies have lived up to the promise of providing novel treatment options for previously intractable cancers such as colorectal, lung and myeloma. They have been a boon to patients who have been given a new lease on life while being spared the morbidities of conventional chemotherapy regimens. Unfortunately, their euphoria may be short-lived, as clinical practice with these marvelous reagents has shown several limitations: Targeted therapy appears to work best for a limited population of patients who have the ‘correct’ target configuration, e.g., Herceptin for HER2 positive, approximately 30 percent of breast cancer patients and Erbitux for KRAS wild type, about 60 percent of colorectal cancer patients. The improvement in median overall survival for most cancers is not long, being generally of the order of months over standard of care alone. It may not be possible to altogether eliminate the use of conventional cytotoxic regimens, as in most cases, the optimal treatment strategy appears to be as combination therapy of the target-specific drug in conjunction with the older regimen. As cancer cells mutate, targets also develop mutations that make them refractory to treatment, and patients eventually develop resistance to the target-based drug, for e.g., Gleevec resistance due to the T315I mutation in BCR-ABL. Pharmacogenomics and treatment strategies There is now a growing body of knowledge on the impact of mutations and genetic polymorphisms on drug responsiveness, which will revolutionize cancer treatment algorithms. Using pharmacogenomics, clinicians can stratify patient populations on the basis of either response or toxicity to certain therapies. This will enable substantial savings in health care costs by fine-tuning therapies towards only those patients who will be responsive, protecting patients who may be at risk for toxic side effects, and using more accurate, individualized dosing regimens. The US FDA has recommended pharmacogenomic testing of patients before administering two cancer drugs currently in the market. Irinotecan/Camptosar is used for the treatment of metastatic colorectal cancer. Individuals who are homozygous for the UGT1A*28 allele are at increased risk of neutropenia following initiation of Camptosar treatment. It has been recommended that UGT testing be done on patients to identify those at the highest risk of neutropenia and start them off on a reduced initial dose. Tamoxifen is used to treat breast cancer. Women carrying the CYP2D6 *4/*4 genotype cannot metabolize tamoxifen to its active form, endoxifen. CYP2D6 genotype testing of post-menopausal patients would determine appropriate usage of tamoxifen. Herceptin, indicated for HER-2 positive breast cancer, was launched along with a companion diagnostic kit for determination of HER2 status in patients before therapy. Clinical studies of patients who are subjected to epidermal growth factor receptor (EGFR) therapies have shown some interesting correlations. In almost all cases and all indications, there is a positive correlation between cutaneous toxicity (skin rashes) and efficacy. More interestingly, mutations in the EGFR kinase domain and the KRAS gene, which is downstream to EGFR, appear to impact the efficacy of therapy. In colorectal cancer, mutations in the KRAS gene negatively affected responsiveness to cetuximab/Erbitux, whereas patients having the wild type allele in exon 2 (60 percent) showed improved overall survival after Erbitux treatment. In non-small cell lung cancer, mutations in the EGFR kinase domain increased the sensitivity to erlotinib and gefitinib, whereas patients carrying the wild-type alleles were less responsive. Also, mutations in the KRAS gene conferred resistance to the two drugs. Smokers appeared to predominantly harbor KRAS mutations.  The advent of high-throughput DNA microarray and quantitative real-time PCR (qRT-PCR) technologies for gene expression profiling has made possible pharmacogenomic testing using multiple genetic markers and ‘gene signatures’ or profiles comprising hundreds of genes. These tests can be used as diagnostic or prognostic indicators to determine optimum treatment strategies. There are several commercially available gene signature tests for breast cancer and colorectal cancer. OncotypeDX from Genomic Health is a 21-gene recurrence score assayed by qRT-PCR to predict the risk of breast cancer recurrence and identify those patients with a low risk and therefore may not need adjuvant chemotherapy.  DxS Diagnostics/Targeted Molecular Diagnostics has developed a KRAS mutation assay to detect metastatic colorectal cancer patients resistant to EGFR antibody therapies. Cancer drug discovery in India Biocon has launched a monoclonal antibody drug called Biomab-EGFR for head and neck cancer in India. Actis Biologics Pvt. Ltd. (ABPL), a start-up biotech, is developing Angiozyme/ABI873, an angiogenesis inhibitor, for colorectal cancer. Angiozyme belongs to a new class of RNA molecules called ribozymes that selectively bind to a mRNA target and degrade it. The target for ABI873 is the receptor VEGFR1, which mediates tumor angiogenesis. The molecule has been in-licensed from Sirna, now acquired by Merck, and has completed one phase-II trial in the US that showed responsiveness in colorectal cancer patients having elevated levels of soluble VEGFR1. ABPL has filed an Investigational New Drug (IND) with the Drugs Controller General of India (DCGI) to conduct an expanded colorectal cancer trial in India using VEGFR1 as a biomarker to select patients eligible for Angiozyme therapy. Piramal Lifesciences is developing P-276, an inhibitor of cyclin-dependent kinase-4 (CDK-4), targeting the cell cycle, it is currently in phase-II trial for multiple myeloma in the US. The future In addition to biologicals such as monoclonal antibodies, the armamentarium of cancer drugs now includes new classes of chemical entities such as anti-sense RNA molecules, cancer vaccines and gene therapy. Many promising therapies are in late stages of clinical development, focusing a wide variety of targets involved in cell proliferation, differentiation and other pathways related to carcinogenesis (cyclins, cyclin dependent kinases, kinesins, Hsp90-Hedgehog pathway, etc.). While the central challenge of screening and timely detection of cancer at an early stage continues to remain elusive, the significant progress that is being made in pharmacogenomics approaches promises better therapeutic outcomes in the future. Epigenetics and knowledge of the epigenome (patterns of DNA methylation and histone modification) will enable development of new diagnostics tools, better prognosticators and predictors of responsiveness to treatment. ]]> <![CDATA[Key Technology for Studying Genomic Data]]> https://biospectrumindia.com/news/95/2086/key-technology-for-studying-genomic-data.html https://biospectrumindia.com/news/95/2086/key-technology-for-studying-genomic-data.html Tue, 10 Mar 2009 12:56:00 +0530 Key Technology for Studying Genomic Data —Anuradha Acharya, CEO, Ocimum Biosolutions The advent of microarrays and their ability to measure several thousands of gene expression have   brought a massive change to the traditional methods that assayed a few genes at a time. Microarray technology has been a key technology for studying genomic data and gene expression. It offers several opportunities to make predictions and validations on key pathways, biomarkers and other biological observations of clinical interest. The current applications of microarray technology in diagnosis of cancer and other diseases show its true potential and it also lead the way for further developments in this exciting field of genomics. DNA microarrays can be used to measure changes in expression levels, to detect single nucleotide polymorphisms (SNPs) and in genotyping or in resequencing mutant genomes. Conventional methods of research on diseases and comprehensive molecular level screening using microarrays are revolutionizing therapeutic medicine and the field of diagnostics. Evolution It all started with photolithographic printing in 1991 and it went through several technological iterations. In 1997, the genome-wide expression monitoring in yeast paved the way to key application areas. Today, the science of microarrays has evolved to open up new areas for development, which include agriculture, chemicals, cosmetics,  food and nutraceuticals are of much interest in the past few years besides drug discovery, development and diagnostics. Manufacturers will continue to see newer applications in other areas as well. Market potential Affymetrix, Agilent, Illumina, Ocichips and other cDNA and spotted array platforms are key platform innovators in the Microarray space. Numbers are deceptive, but global market for microarrays can grow at an annual average of 6.5 percent and might touch $2.5 billion in 2010. The commercial DNA microarray segment, which currently accounts for approximately 57 percent of the market revenues, is projected to grow faster. The future prospects Array, bead or massive parallel sequencing-based platforms Deep sequencing and epigenetic-profiling SNP Gentyping using next-gen sequencing Digital quantificatio using Solexa Copy number variations using 454 ]]> <![CDATA[DNA Chip, Microarray Revolutionize Genomic Analysis]]> https://biospectrumindia.com/news/95/2041/dna-chip-microarray-revolutionize-genomic-analysis.html https://biospectrumindia.com/news/95/2041/dna-chip-microarray-revolutionize-genomic-analysis.html Tue, 10 Mar 2009 12:54:00 +0530 DNA Chip, Microarray Revolutionize Genomic Analysis DNA microarray has emerged as a prime technology for the performance of gene expression  analyses. Combined with bioinformatics and other advanced technology, it offers numerous applications with absolute accuracy. Availability of whole genomic sequences of many organisms have created the need for high throughput analysis of gene expression patterns and the DNA chip and microarray technology have revolutionized functional and genomic analysis at this level. This technology uses a single chip to  monitor the whole genome so that researchers can have a better picture of the interactions among thousands of genes simultaneously. In the past several years, this new technology has attracted  several biologists as it generates large amount of data in little time and facilitates the quantification of thousands of genes from many samples DNA microarrays are used to examine the gene expression changes in cancer patients. Tumor profiling, using DNA microarrays, allows the analysis of the development and the progression of complex diseases. The technology allows scientists to examine targets for drug discovery, potential diagnostic and prognostic biomarkers for many complex diseases; detect viruses and other pathogens from blood samples and thus evolved as a pathogen detection method. DNA microarrays are recently used to identify inheritable markers, and therefore used as a genotyping tool. SNP chips based on DNA microarray technology allow the high throughput profiling of single nucleotide polymorphisms using a chip or array approach.  This has allowed polymorphisms to be more quickly assayed and also their relevance to disease to be easily determined. Today, the technology has emerged as an indispensable research tool for gene expression profiling and mutation analysis. The beginning Microarray technology has evolved from southern blotting, where fragmented DNA is attached to a substrate and then probed with a known gene or fragment. The use of a collection of distinct DNAs in arrays for expression profiling was first described in 1987, and the arrayed DNAs were used to identify genes whose expression is modulated by interferon. These early gene arrays were made by spotting cDNAs onto filter paper with a pin-spotting device. The use of miniaturized microarrays for gene expression profiling was first reported in 1995, and a complete eukaryotic genome (Saccharomyces cerevisiae) on a microarray was published in 1997. Affymetrix further developed DNA microarrays which were based on high-density 25-mer oligos from human cDNA sequences. Microarrays were originally designed to measure gene expression levels of a few genes.  Terminologies that have been used in the literature to describe this technology include biochip, DNA chip, DNA microarray, and gene array.  Affymetrix, Inc. owns a registered trademark, GeneChip, which refers to its high density, oligonucleotide-based DNA arrays. Today, there are more than 1,000 microarray core facilities are available and over 100 service companies are offering microarray processing services worldwide. India is a late entrant to the microarray world. However, rapid progress in the last few years has resulted in establishment of over 50 microarray facilities and five commercial microarray service providers in India. Application advances As more information accumulates, scientists could able to use microarrays to ask increasingly complex questions to perform more intricate experiments. With new advances, researchers are able to better understand the functions of new genes based on similarities in expression patterns with those of known genes. Ultimately, these studies promise to expand the size of existing gene families, reveal new patterns of coordinated gene expression across gene families, and uncover entirely new categories of genes. Furthermore, because the product of any one gene usually interacts with those of many others, our understanding of how these genes coordinate will become clearer through such analyses, and precise knowledge of these inter-relationships will emerge. The use of microarrays may also speed up the identification of genes involved in the development of various diseases as it enables scientists to examine a much larger number of genes. This technology will also help in the examination of integration of gene expression and function at the cellular level, reveals how multiple gene products work together to produce physical and chemical responses for both static and changing cellular needs. Developing new protein arrays and constructing miniaturized flow-through systems, which can potentially take this technology from the research bench into industrial, clinical and other routine applications, exemplify the intense developments that are now ongoing in this field. Recent growth in the field of protein microarray shows the potential applications of enzyme–substrate, DNA–protein and different types of protein–protein interactions. The technology is now more heavily regulated in terms of the bioinformatics, which has led to the generation of more credible results. Rini Mukherjee Saxena, senior product manager, Agilent Technologies said, ‘’Many studies have focused on the methylation state of specific genomic sites that are thought to play important roles in cellular processes. Conventional methods of analyzing this event are labor intensive, low-throughput and expensive. Microarray-based methods have evolved as powerful high-throughput analysis tools capable of detecting and mapping DNA methylation changes on a previously unachievable genome-wide scale.” Other researchers in the field expect that DNA chips will enable clinicians and in some cases even patients to quickly and inexpensively detect the presence of a whole array of genetically based diseases and conditions, including AIDS, Alzheimer’s disease, cystic fibrosis, and some forms of cancer. Moreover, the technology could make it possible to conduct widespread disease screening cost-effectively, and to monitor the therapies more effectively. So far, only a few companies have commercialized DNA-chip products, and the barriers to market entry remain great. Challenges Microarray technology is an expensive technology in terms of cost of required equipment, reagents and trained manpower. The technology is rapidly advancing; frequent upgradation of machines and methods becomes a major bottle neck in maintaining a microarray lab. The major hurdle in the efficient utilization of microarray technology is the lack of trained manpower to analyze the microarray data. Expertise in spread sheet and database operations and analysis packages are essential for efficient statistical analysis of data and to find significant patterns. As DNA-chip companies prepare to bring their products to market, they have to face major technological, manufacturing  and regulatory challenges. The technology trade-offs involve finding ways to increase the number of arrays on a single chip, as well as increasing the rate of production to meet expected demand. The main challenge involves achieving all these market-oriented parameters at a cost that supports a commercially acceptable price. In a tight managed-care marketplace that places a premium on technologies that can either show quick savings or more-efficient results, some analysts say that such unit prices will limit the growth of the DNA-chip market. Future Microarray technology offers a ray of hope to personalized drugs and molecular diagnostics as it enables global views of biological processes. With technical development that offers increased sensitivity, microarray technology is expected to become an indispensable tool in the fields of biology, biotechnology, drug discovery, and other application areas. If DNA microarray is used for the development of pharmaceutical products, it can considerably reduce the cost and time for the entire process of drug discovery and development, and can also contribute in developing personal drugs. Although this marketplace is in its infancy, with considerable challenges remaining to be overcome, the speed with which manufacturers are progressing toward commercialization will soon make DNA chips a viable alternatives to traditional chemical assays. Indeed, manufacturers hope that within a decade they will usher in a new era in diagnosis and treatment for diseases and conditions that have genetic origins. Jahanara Parveen ]]> <![CDATA[â€œThe Global Market for LIMS is $350 Millionâ€?]]> https://biospectrumindia.com/news/95/1396/the-global-market-for-lims-is-350-million.html https://biospectrumindia.com/news/95/1396/the-global-market-for-lims-is-350-million.html Tue, 10 Mar 2009 12:33:00 +0530 “The Global Market for LIMS is $350 Million” -Kim Shah, director, Global Marketing of Informatics Thermofisher Scientific What is the market potential of LIMS in today’s scenario?  In the first half of 2008, the market for LIMS was quiet exciting in India but then it slowed down quiet a bit in the second half. Even though global conditions are quiet bad but that didn’t affected India badly. There will still be growth but again it will not be in the first quarter but in the second quarter because everyone is in a wait and watch mode. The market value of informatics business is roughly around $100 million, the proper market for LIMS worth $350 million globally out of which in India and China have a growth rate of 7-10 percent a year. Where do you see growth in LIMS market in the coming years?  I really see growth in a new service called software as a service (SAAS). Typically for any software we have to download and configure it. Three years ago, a company named Salesforce.com came up with this idea, which doesn’t require any downloads. All you have to do is just go to the internet key in www.lims.com and then immediately you will be connected to the concerned server. There is no need for investments like IT and server, all the functionalities are available online. In the LIMS space we are going to come out with that model this year. So SAAS as a model will work very well for small and medium size companies which are cutting cost and do not have an IT staff. What are the market requirements and trends in LIMS space?  In India, LIMS space is similar to the western market. The businesses started soon after the CRO market reached India. LIMS is a matured market because it has been there for such a long time, there is not much excitement  from the innovation point of view. We are working on an agenda which I call point-to-point integration wherein we will have systems talking to each other, work done simultaneously rather than one job at a time  No company can be an expert in everything. What we will do is provide a connection and be a glue between different systems and prepare a road map for their work flow. Taking LIMS and integrating it into the enterprises has become a trend now. Our challenge is to further the growth of the active LIMS market. That is why we are really banking on the SAAS model and the integration model. If one or both takes off we hope to see a growth of 5-6 percent. Like for example, for Watson (one of Thermo’s product introduced in India), we are trying to improve on it so that later it will be applicable to the entire work flow rather than just a part of it. What is the LIMS scenario in India and China? India is lot more IT friendly than China. In China, any explanation of a software has to be translated into Chinese which becomes very difficult at times. On the positive side the Chinese government is very proactive, once they have decided on something they are determined to get it. Because of many restrictions, the western pharmaceutical companies did not have much relationship with China. The CRO market does not exist in China but there is a lot of scope for animal testing. The pharma market in China is not that prevalent. India has a LIMS market, but it is focused on petrochemicals and not in life sciences. The LIMS market in China as well as India is growing at a rate of 10 percent. Especially in this era of recession I think India and China are the only two markets which will continue to grow in the next two years. Nayantara Som ]]> <![CDATA[LIMS, a Comprehensive Enterprise Solution]]> https://biospectrumindia.com/news/95/2053/lims-a-comprehensive-enterprise-solution.html https://biospectrumindia.com/news/95/2053/lims-a-comprehensive-enterprise-solution.html Tue, 10 Mar 2009 12:31:00 +0530 LIMS, a Comprehensive Enterprise Solution The LIMS technology has given a new insight to scientists for conducting experiments more efficiently and providing greater lab productivity and functionality along with automated reporting capabilities. Laboratory Information Management System (LIMS) is a computer software that is used in the laboratory for the management of samples, laboratory users, instruments, standards and other laboratory functions such as invoicing, plate management, work flow automation etc. LIMS are therefore the information management system designed specifically for the analytical laboratory. One of the most important aspects of LIMS is the ability to prepare and retrieve data and turn it into information quickly and easily. The LIMS has thus been able to eliminate the time consuming tasks of manual report preparation that often preclude access to the desired information. A full-featured LIMS manages various lab data that ranges from sample log-in to reporting the results. LIMS has streamlined the data flow within organizations and has centralized the information in one primary database. The LIMS solution unifies vast and disparate volumes of biological and chemical data along with their related applications and tools, into a single, browser-based scientific interface. Built mostly on an extensible life science-based data model, the LIMS platforms function on the basis of the context of data being integrated, the relationships between associated data, and allows scientists to use the platform to query, view and analyze research data without reformatting the data-gathering methodology or changing multiple product interfaces. Today, LIMS has become a comprehensive enterprise solution that enables research organizations to focus their time and effort on production of scientific information. Scientists are now able to leverage and utilize individual work flow within the overall process flow to meet their unique requirements. LIMS has also created a powerful environment in which scientists can interpret their results. Sample data are quickly combined with data integrated from public or proprietary databases by creating a web of information that provides a context for analysis. In addition, integration with the best technologies, platforms and web-based search engines has enabled scientists to quickly transform data into meaningful information. History Originally, LIMS were developed in-house by organizations wishing to streamline their data acquisition and reporting processes. In-house LIMS, which are still being developed by many organizations, take considerable time and resources for its implementation. The need for a more immediate solution helped to drive LIMS to the next stage in the 1970s. During this time, custom-built systems became available. These early custom systems were one-off solutions designed by independent systems development companies to run in specific laboratories. Parallel to these custom-built LIMS implementations were the initial efforts to create commercial LIMS products. These extensive research efforts resulted in the first commercial solutions that were formally introduced in the early 1980s. Such commercial LIMS were proprietary systems, often developed by analytical instrument manufacturers to run on the chromatographs that the instrument  manufacturer produced. These commercial systems, while typically developed for a particular industry such as the pharmaceutical industry, still required considerable customization to meet a specific laboratory’s needs. In particular, laboratories often required very specific format and reporting requirements. However, such demands for customization increased the cost of the commercial LIMS and extended the implementation time. Parallel to the rise in commercial LIMS was the increase in processing speed; the increase in third-party software capabilities; and the reduction in PC, workstation and minicomputer costs. These advantages were transferred to the laboratory and LIMS environment that resulted in a migration from proprietary commercial systems toward an open systems approach that emphasizes user-configurability rather than customization, which took place in the 1990s. Today, LIMS tools are extensively being used in the small and large sized companies. Kim Shah, director, Global Marketing of Informatics, ThermoFisher Scientific said, “Today, there are more than a dozen companies operating in this space. LIMS first started in Europe and then in the US and gradually due to maturity of markets there and partly because the big pharma started making lesser medicines, they are now shifting their focus to emerging markets.”  Technological development Today’s commercial LIMS offer a high degree of flexibility and functionality. Many of the most popular commercial LIMS take advantage of open systems architectures and platforms to offer client/server capabilities and enterprise-wide access to lab information. Web-based LIMS, or a web-based front-end to the LIMS, are also offered by many vendors. Extensible Markup Language (XML) is being incorporated into LIMS because it can enhance the information in documents, simplify web automation, and integrate applications within or between organizations. XML not only offers a more streamlined way to transmit data to web applications, but it can also be validated. XML is considered as the next generation LIMS. Informatics is redefining this field. The rise of informatics, coupled with the increasing speed and complexity of the analytical instruments, is driving more sophisticated data manipulation and warehousing tools that work together with LIMS to manage and report laboratory data with ever greater accuracy and efficiency. Early LIMS were custom-designed and built as point solutions to meet the needs of specific laboratories. This type of in-house systems need significant effort to develop and while they may produce a very close fit to the initial requirements, they can prove difficult to change or modify in response to changing laboratory and business practices. Commercial LIMS products were initially developed in the early 1980s. At first these systems often required significant customization to meet a specific laboratory’s needs as far as work flow and reporting were concerned. This increased the cost of the LIMS setup and extended the implementation time required. Open LIMS systems As computing technology changed, LIMS technology developed in parallel and a move towards more open and configurable COTS (Commercial off the Shelf) systems took place. This provided laboratories with greater flexibility to meet their needs within a standard commercial package. Today’s LIMS solutions offer even greater flexibility and functionality. Many popular commercial LIMS packages utilize open system architecture to offer client capabilities and enterprise-level access to lab data within a client server environment. Some vendors offer the same capability within a truly web-based LIMS using technologies such as Microsoft’s .Net platform. XML enhances the data in documents, maintains data longevity by storing it in an application neutral format, simplifies automation, and integrates data and information within organizations. This, together with the adoption of technologies such as web services, allows for enhanced and simplified integration with other systems within the laboratory or organization. Combined with a fully integrated Scientific Data Management Systems (SDMS), LIMS now has the potential to bring all laboratory data together in a single unified repository. Next level of development The impact of informatic technology has always been a bonus for the LIMS industry. Internet, HTML, XML and  hardware improvements have made data management tasks much easier to perform. Portable or wireless devices are part of these trends. Experts predict that wireless technology is on the ascendant at the same time the web-deliverable LIMS are finally gaining market acceptance. The drive to provide even  more functional and productive technology results in easy to use and less expensive LIMS solutions, laboratories worldwide will be able to acquire, manage and report their data in more interesting ways. Anuradha Acharya, CEO of Ocimum Biosolution said, “The new wave of LIMS that we at Ocimum are developing through our product Biotracker is to enable open methods to integrate other applications and also to act as a web-based data management service for remotely managing requests in real time. This model is a SAAS (software as a service model) and incorporates the new web 3.0 standards and allows multiple collaborators to not only exchange data but also use the LIMS in a ‘services on-demand’ model. Latest LIMS systems This latest generation of LIMS moves away from simple sample test and result management to provide the laboratory with a sophisticated laboratory informatics architecture. This model allows efficient management of data and information generated or used by the laboratory.  Latest LIMS systems effectively manage the delivery of the laboratory product and optimize the performance of the laboratory organization. In addition, the value of historical data assets can be maintained by ensuring continued accessibility of this data in a single application. Jahanara Parveen Technological Upgradation Over the Years —Anuradha Acharya, CEO, Ocimum Biosolutions The earliest desire to develop a LIMS by organizations was taken forward by geeky scientists who wanted to streamline their data throughput and reporting processes. The fact that an in-house LIMS can take considerable time and resources to implement was learnt by the industry the hard way. The need for a more immediate solution helped to drive LIMS to the next stage in the 1970s. During this time, custom-built systems became available. These early custom systems were one-off solutions designed by independent systems development companies to run in specific laboratories. Parallel to these, custom-built LIMS implementations were the initial efforts to create commercial LIMS products. These extensive research efforts resulted in the first commercial solutions that were formally introduced in the early 1980s but the focus was more on ‘quality control and assurance’ and subsequently production systems. These commercial systems, typically developed for a particular industry (such as the pharmaceutical industry), in spite of their ‘off the shelf’ status require a considerable customization to meet a specific laboratory’s needs, sometimes to fine-tune and other times to tune to the scientist’s formatting requirements. The desire for very specific format, reporting requirements and the restrictions of the technology made cost of the commercial LIMS to skyrocket and extended its the implementation time. The new breed of LIMS now offer much higher configurability and allows users to implement multiple work flows and processes with ease. It doesn’t require too much intervention from the IT departments. In several cases it can be remotely monitored and managed taking off those challenges from the users and also reducing the cost of installation, customization and maintenance. Most LIMS products allow the laboratory to automate manual processes like register work requests; print reports; monitor and communicate sample, process and resource related issues; schedule and approve requests besides data security and search ability. The real value of a LIMS is the ability to maximize sample throughput and minimize labor costs. Major players in this space are Ocimum, Thermo Fisher and Labware. Pricing models usually have two components which include license costs and some customization costs. ]]> <![CDATA[LC, the Widely Accepted Chemical Analysis Technique]]> https://biospectrumindia.com/news/95/5927/lc-the-widely-accepted-chemical-analysis-technique.html https://biospectrumindia.com/news/95/5927/lc-the-widely-accepted-chemical-analysis-technique.html Tue, 10 Mar 2009 12:22:00 +0530 LC, the Widely Accepted Chemical Analysis Technique —Madhu Nayak, business development manager, Life Sciences, GE Healthcare Chromatography is a family of separation techniques in which a mixture dissolved in ‘mobile phase’ is passed over a ‘stationary phase’ which separates the analyte to be measured from other molecules in the mixture. In liquid chromatography the mobile phase is a liquid and the fixed phase is in a column or a plane. Chromatography began to take its modern form following the work of Martin and Synge in the 1940’s and 1950’s. Up to the mid-1970’s most chemical separations were carried out using a variety of techniques including open-column chromatography, paper chromatography and thin layer chromatography, these were not easily quantifiable and also lacked resolution. High performance liquid chromatography (HPLC) was introduced in the mid-1970’s and rapidly improved with particle chemistry performance and the conveniences of online detectors. In the early 1980’s two Swedish manufacturers launched biocompatible LC systems that overcame the difficulties of working with biological material. In 1981, Pharmacia Biotech launches the fast protein liquid chromatography (FPLC) system, a completely new concept for chromatographic protein separations on a laboratory scale. Today, the HPLC and FPLC techniques are widely used in biotechnological, biomedical and biochemical research as well as in the pharmaceutical industry. Newer applications extend into energy, food, cosmetics and environmental industry. New developments The design and development of newer chromatographic matrices and sub-2 micron particles are a significant challenge. Using ultra performance liquid chromatography (UPLC), it is now possible to take full advantage of chromatographic principles to run separations using shorter columns packed with 1.7 to 1.8 micron particles for increased speed, superior resolution and sensitivity. UPLC combined with mass spectrometric detection ( UPLC-MS) is used widely in the bioanalysis of small molecule drug candidates in plasma. UPLC-MS has shown to increase sample throughput by reducing run times over three-fold without compromising on sensitivity or resolution. Some vendors, the leaders being Waters, Agilent and Shimadzu, report more than 10-fold faster separations for some samples. UPLC or HPLC is projected to be the fastest growing segment of LC. Over the next five years UPLC or HPLC is expected to produce a compounded annual growth rate of  nearly 10 times than that of conventional LC. Chromatography matrices The enlarged family of LC, besides normal and reverse phase, includes gel permeation, gel filtration, desalting, ion exchange, affinity, hydrophobic interaction, chromatofocusing, chiral, etc. each making use of a particular physicochemical property of molecules to bring about separation. Newer stationary matrices allow applications for tagged, high-throughput, refolding proteins and antibodies with or without a system for the purification. Polymer based matrices score over silica- based matrix on its wider operating range of pH particularly for peptide separations. The world’s first gel filtration medium, Sephadex was first invented in Uppsala, Sweden in 1957 and in 1960 it was launched by Pharmacia as a commercial medium for chromatography. Now GE Healthcare has the world’s largest installed capacity for the production of chromatography media, with an annual capacity of 4,50,000 liters and/or kilograms. Future Disposable solutions enable lean production schemes by eliminating waste activities in daily routine. This plug and play concept is especially apt for multi-product production facilities. In this concept, comes the newly launched AKTAready, a LC system designed for process scale-up and production for phase I–III drug development and full-scale production to good laboratory practices (GLP) and good manufacturing practice (GMP) standards. The spread of the technology to new segments of users is the primary driver for the liquid chromatography market, its market revenues is estimated to cross $2 billion by 2012. LC has played a significant role in the life sciences revolution, particularly in protein purification, peptide fractionation and sequencing, amino acid analysis and DNA sequencing. Very small chip-based systems may in the future change how chemical analysis in biology, medical research and healthcare evolve over the next 10-15 years.   ]]> <![CDATA[Mass Spectrometry in Characterization of Biotherapeutics]]> https://biospectrumindia.com/news/95/2927/mass-spectrometry-in-characterization-of-biotherapeutics.html https://biospectrumindia.com/news/95/2927/mass-spectrometry-in-characterization-of-biotherapeutics.html Tue, 10 Mar 2009 12:19:00 +0530 Mass Spectrometry in Characterization of Biotherapeutics —Dr. John C Gebler, director, Biopharmaceutical Sciences, Waters Corporation Mass spectrometry (MS) has been a useful tool for chemists and scientists for almost 100 years. The technology has evolved at a rapid pace. It took over 70 years to develop technology that would allow the mass analysis of biopolymers. In the late 1980’s electrospray ionization (ESI) methods were demonstrated to obtain good mass analysis of intact proteins. This method quickly became commercial instrumentation in the early 1090’s. Since ESI-MS acted upon aqueous samples, the interfacing of liquid chromatography (LC) soon became a standard method. In 1997, Waters Corporation acquired MicroMass. This marriage brought together a premier MS manufacture with a premier LC company. At that time, proteomics was at its genius and evolving rapidly. This positioned Waters as a major supplier of LC and quadrupole time of flight (QTof) MS systems of complex peptide mixtures from biological samples. More recently, Waters has become a global player in providing system solutions for the characterization of biopolymers. A system solution is defined as the combination of sample prep, LC, column chemistry, MS system, and informatics. Each element has been optimized to provide extraordinary performance, robustness, and engineered simplicity. Today, mass characterization of intact monoclonal antibodies with high mass accuracy is routine and can be completed in four minutes. Peptide maps benefit from UPLC systems resulting in high resolution separations and reproducibility. Today, informatics tools like BiopharmaLynx have greatly reduced the burden of data analysis. Currently there are solutions for intact proteins, peptide maps, synthetic oligonucleotides and peptides, glycans, amino acid analysis, and media analysis. ]]> <![CDATA[LC-MS, a Capable Integration]]> https://biospectrumindia.com/news/95/1905/lc-ms-a-capable-integration.html https://biospectrumindia.com/news/95/1905/lc-ms-a-capable-integration.html Tue, 10 Mar 2009 12:09:00 +0530 LC-MS, a Capable Integration LC-MS, a Capable Integration LC-MS has emerged as the most preferred technique for routine bioanalysis and there is no doubt that this technology will continue towards more automation and wider range of applications in the coming years. Liquid chromatography-mass spectrometry (LC-MS), the analytical chemistry technique that combines the physical separation capabilities of liquid chromatography with the mass analysis capabilities of mass spectrometry has emerged as a powerful technique used for many applications with very high sensitivity and specificity. The applications of LC-MS are used in innumerable analytical fields, including pesticide-residue determination. There is no doubt that LC-MS is currently competing with gas chromatography (GC)-MS for the status of reference analytical technique to determine pesticide residues and that its ever-increasing application is bound to the evolution of modern instruments and their growing performance qualities. Strategies in the drug discovery and drug development processes are undergoing radical change. For example, the contribution of pharmacokinetics to both processes is increasing. Furthermore, toxicokinetics is established as an essential part of toxicity testing. With this emphasis in the use of pharmacokinetics/toxicokinetics and the greater potencies of newer drugs, a sensitive and specific bioanalytical technique is essential, LC-MS and liquid chromatography-tandem mass spectrometry (LC-MS/MS) have emerged to fulfill that need. LC-MS/MS can be considered to be the major bioanalytical development of this decade. LC-MS has become very common in pharmacokinetic studies of pharmaceuticals. The last few years have witnessed its extensive use in the study of proteomics. It is frequently being used in drug development at many different stages including peptide mapping, glycoprotein mapping, natural products dereplication, bioaffinity screening, in vivo drug screening, metabolic stability screening, metabolite identification, impurity identification, degradant identification, quantitative bioanalysis, and quality control. Technology upgradation The last few years have seen a significant movement toward using single nanoscale LC-MS methodologies that are capable of qualitative profiling and quantitative analysis of complex mixtures of proteins across wide concentration ranges and the main focus is in things at the lowest concentrations. Scientists are hence relying on analytical instruments for structural information on individual low-abundance proteins and simultaneously get a true fingerprint of all of the proteins in a given cell. It has become possible for LC-MS techniques to uncover 1,500 proteins in a single analysis. The major development in MS has been the use of tandem MS-MS where a researcher can program the detector to select certain ions to fragment. The process is essentially a selection technique, but is in fact more complex. As long as there are no interferences or ion suppression, the LC separation is quite fast. It is common now to have analysis time of one minute or less by MS-MS detection, compared to over 10 minutes with UV detection. Some of the key improvements in liquid chromatography and mass spectrometry come from better software, such as Waters Corporation's Micromass ProteinLynx Global Server 2.0, which integrates key mass informatics tools for protein identification and characterization. Such a combination of liquid chromatography, mass spectrometry, and powerful software have proved to be useful in disease target identification and drug discovery. MS Detector for HPLC "Quadrupole LCMS will continue to see robust demands in future" -Senya Imamichi, managing director, Shimadzu Analytical (India) Pvt Ltd Not long ago Shimadzu pioneered the introduction of Photodiode array detectors which went on to replace the conventional UV-VIS detectors in HPLC. The launch of LCMS-2020 in 2009 by Shimadzu heralds a new era in desk top Mass Spectrometric Detectors for HPLC systems that have the capability to address the most demanding requirements in pharmaceutical and life sciences. The development of LCMS 2020 is based on Shimadzu's proven Mass Spectrometry platforms which adopted simple, easy-to-use design while maintaining superior performance. Delivering the ultimate in measurement speed and sensitivity, the compact LCMS-2020 mass spectrometer offers faster measurements and higher detection sensitivity for quicker and more accurate analysis of trace impurities, environmental pollutants, and contaminants in different sample matrices. When combined with a Prominence ultra-fast LC (UFLC/UFLCXR) the system helps analysts achieve the ultimate in separation performance and productivity. The single quadrupole system of LCMS-2020 uses a patented ultrafast(UF) technology providing significantly higher sensitivity than any other single quadrupole analyzer and offers unique cost effective solutions to a range of analytical requirements such as mass identification, process monitoring, mass based purification etc. The new UFscanning technology achieves measurement speeds of 15,000 u/sec without sacrificing sensitivity or resolution, thus obtaining the best chromatography for the fastest LC conditions. UFSwitching technology of LCMS-2020 enables switching between positive and negative ion modes in 15 milliseconds so even the fastest LC peaks can be analysed in both modes, thus increasing productivity. Innovative ion optics with the newly developed Qarray® ion optical system provide superior sensitivity, repeatability, and linearity, achieving 50% to 300% greater sensitivity than any other single quadrupole analyzer for substances most commonly measured. Users can inject less and keep the analyzer cleaner, longer. LCMS-2020 enables improved high mass operation with sensitivity increased by more than 500 percent for masses above 1,000. In addition to better performance, the LCMS-2020 allows easier maintenance, permitting users to replace the ionization unit and inlet capillary to the MS from the LC, without breaking the vacuum. The ESI method typically used for LCMS can be replaced with APCI, which is suitable for neutral compounds, or with a dual ionization source (DUIS) for simultaneous operation of both ionization modes, quickly and without tools. The new Shimadzu LCMS-2020 with its breakthrough technology is the world's most sensitive, fastest scanning and fastest polarity switching single quadrupole mass spectrometric detector available. The launch of LCMS-2020 recently at Delhi attracted a large number of Mass Spectroscopists from the Pharmaceutical Industry. The strength of single quadrupole mass spectrometric detectors lies not only in their adoption by HPLC users but also by the pharmaceutical industry as a whole. Applications on DMPK (Drug Metabolism and Pharmacokinetics) and compound screening are particularly well suited for single quadrupole LCMS. Besides its high resolution and accuracy, LCMS is also a high-throughput technique capable of meeting a number of pharmaceutical industry's needs from R&D from analytical services, to method development and quality control. With increases in Pharmaceutical R&D spending and advancements in drug development, single quadrupole LCMS will continue to see robust demands in future. Market scenario In 2008, Waters introduced its Xevo family, the new range of mass spectrometers for most demanding applications. The company's IntelliStartTM technology was first introduced with the ACQUITY SQD and TQD systems. The technology automatically ensures that the instrumentation is ready to use and automatically generates methods for the quantification of trace analytes in samples. â€œEasy to operate and reliable instrumentation can make a significant contribution in helping a scientist to be more productive. LC-MS/MS is a very powerful analytical tool that can benefit a wide range of different businesses. Today we recognize that within many organizations a broad range of scientists need to access LC-MS/MS instrumentation,â€? said Kochu Sankar, general manager, Marketing, Waters India. The most common technology platforms used in laboratories around the world for detecting chemical contaminants such as melamine in food are 'hyphenated' systems that combine chromatography with mass spectrometry. â€œToday, LC-MS QQQ methods are available for detection of melamine. While the limit of detection (LOD) is significantly lower than that of the GC-MS method, the LOQ is still relatively high. Solid phase extraction during sample preparation and IEC, LC-MS-MS methods simplify the sample preparation process since no derivatization is necessary, and they provide confirmation and quantification in one step,â€? opined Dr. Jerry Zweigenbaum, market development specialist, LC-MS, Agilent Technologies. According to Ajit Srivastava, business manager-LC-MS, Agilent Technologies, the latest development in this field is the 'microfluidic-based nanoflow HPLC-Chip'. HPLC-chip provides fast chromatography, the best sensitivity and excellent reproducibility in retention time, which are crucial for quantitation analysis. The system has superior usability and is ideally suited for 'walk up to' lab environment. The HPLC-Chip/QQQ system can achieve sensitivity in the low attomole range with five orders of magnitude in dynamic range. To achieve best quantitation and specificity, excellent chromatography separation and retention time reproducibility are crucial. Future technologies Although the use of LC-MS for bioanalysis began only some ten years ago, growth in the development and applications of this technology has been phenomenal. The performance to cost ratio of the necessary equipment is being improved continuously. The advent of the ion-trap as a tandem MS quantitative detector for routine bioanalysis probably represents a notable breakthrough in terms of performance-cost ratio, despite some compromise in performance such as sensitivity and precision, when compared to triple-quadrupole instruments. Today, instrument manufacturers are more focused on their product range and the equipment is increasingly dedicated to specific applications. Also, with the advances in pumping technology, electronics and software control, instrument manufacturers are able to design machines that are smaller, simpler to use and with a much better performance to cost ratio. A new generation of LC-MS interfaces that are more amenable to the use of non-volatile buffers and ion pairing reagents are being developed. The technology for automated sample preparation continues to improve. As the range of available packing materials for solid-phase extraction increases, more and more bioanalytical methods will be based on this extraction approach. In the near future, automated SPE systems or on-line precolumn switching capabilities are expected to become an integral part of a bioanalytical LC-MS/MS system. Other automated SPE methodology will be based on immunoaffinity columns and other molecular recognition approaches. Development of the technology will therefore continue towards more automation and to include an even wider range of applications. Jahanara Parveen ]]> <![CDATA[PCR, a Nobel Prize Winning Technology]]> https://biospectrumindia.com/news/95/4607/pcr-a-nobel-prize-winning-technology.html https://biospectrumindia.com/news/95/4607/pcr-a-nobel-prize-winning-technology.html Tue, 10 Mar 2009 12:07:00 +0530 PCR, a Nobel Prize Winning Technology —Dr. Bhuwnesh Agrawal, chairman and managing director, Roche Diagnostics India More than 30 years ago, the introduction of recombinant DNA technology as a tool for the life sciences revolutionized the study of life.  Molecular cloning allowed the study of individual genes of living organisms; however this technique was dependent on obtaining a relatively large quantity of pure DNA.  This depended on the replication of the DNA of plasmids or other vectors during cell division of microorganisms.  Researchers found it extremely laborious and difficult to obtain a specific DNA in quantity from the mass of genes present in a biological sample.    Recombinant DNA technology made possible the first molecular analysis and prenatal diagnosis of several human diseases.  Fetal DNA obtained by amniocentesis sampling could be analyzed by restriction enzyme digestion, electrophoresis, southern transfer and hybridization to a cloned gene or oligonucleotide probes.  However, southern blotting permitted only rudimentary mapping of genes in unrelated individuals.  Polymerase Chain Reaction —a scientific success story Polymerase Chain Reaction (PCR) is a Nobel-prize winning technology used to amplify, or copy on a large scale, specific sequences of genetic material, called Deoxyribonucleic Acid, or DNA. The importance of this technology has moved far beyond its initial purpose of enabling the detailed analysis of DNA for molecular biology applications and gene sequencing. Today PCR plays an active role in disciplines as varied as archeology, forensics, genetics, histopathology, and medicine. Specifically, PCR enables the detection and analysis of DNA for purposes such as: Diagnosis of genetic conditions or illnesses Predicting how well a patient will respond to medical treatment Identifying viruses or pathogens Connecting a suspect to a crime Establishing maternity, paternity or other blood relation Determining identity History of PCR technology First described in the journal Science in 1985, PCR has become one of the most widely used techniques in molecular biology and for good reason: from the daily practicalities of medical diagnosis to the courts of law, PCR takes the analysis of tiny amounts of genetic material to a new level of speed, precision and reliability. Because it is far simpler, faster, and less expensive than previous technologies for analyzing DNA (Southern Blot for example), PCR has “democratized” genetic research, putting a powerful research tool in the hands of all biologists, even those with a limited training in molecular biology. In 1993, the Nobel Prize for the conception of PCR was given to Kary Mullis. The technology was further developed and applied by the labs of Henry Erlich and David Gelfand, both now working at Roche, and other teams of scientists at Cetus. The full history of the technology’s development and application is marked by an extraordinary collaboration of scientists working in a corporate setting, working together to identify and overcome the obstacles to the practical use of PCR for DNA analysis in research and medicine. In 1991, Roche acquired the rights to PCR technology from Cetus and then dedicated significant resources to accelerate the technology’s further advance. From its beginning as a simple but highly manual process to create many copies of a specific region of DNA using a test tube, enzymes a reagents, and a heating source to vary temperature, PCR is now a highly reproducible process that is almost completely automated and therefore simple enough to be applied to many fields of science. Fields of application During the last twenty years, PCR has radically changed the scientific world by making it possible to produce sufficient copies of, or amplify, a portion of DNA for reliable analysis. The list of applications for PCR is lengthy and ever growing. For example, pathogenic organisms can be detected in miniscule amounts of blood, allowing reliable diagnosis and quantitation, thus enabling more rapid medical response. Health and medicine Health, medical treatment and the understanding of disease have all benefited tremendously from PCR technology. In an age where the genetic component of disease is increasingly apparent, PCR will continue to play an important role in medicine. In the late 1990s, the Human Genome Project, which produced the first complete sequence of the human genetic code, drew attention to the potential of understanding the DNA sequence for aiding the development of new drugs and diagnostics, and have uncovered important variations in the nucleotide bases or polymorphisms that make up our genes. These single nucleotide polymorphisms (SNPs) are associated with an increased risk of contracting a variety of common and complex disease, including various cancers and cardiovascular disease, and have become targets for developing new treatments to combat these diseases. The ability of PCR and gene cloning (a procedure that uses organisms such as bacteria and yeast to reproduce genes) to produce sufficient quantities of the DNA code made them instrumental in large-scale sequencing efforts. In the ongoing research of the genome to uncover more information about which genes play a role in disease and why some patients are more susceptible to disease than others, PCR remains critical. For patients today, PCR’s ability to detect genetic variations and mutations has become important for the treatment of such life-threatening diseases as cancer. The term “personalized medicine” refers to the goal of ensuring that each individual patient gets the treatment that will be most successful for him or her. The most innovative new therapies for cancer, drugs such as Gleevec (Imatinib) for chronic myeloid leukemia, Tarceva (erlotinib) for lung cancer, and Herceptin (trastuzumab) for breast cancer, are examples of targeted therapy that are dependant on knowing which gene mutation is present or which genes are expressed in the patient’s cancer tumor. PCR enables the application of personalized medicine by providing reliable and efficient analysis of tumor DNA. In general PCR facilitates the practice of, “translational medicine”, which combines knowledge gathered on the molecular level with that of a patient’s care, based on the direct link between laboratory analysis and practical clinical assessment and management of individual patients. PCR is an essential tool for improving human health in the diagnosis of infectious disease. Physicians and researchers can analyze minute amounts of biological material to track down the source of a viral infection. The use of PCR to detect harmful pathogens is not limited to day-to-day medical diagnosis; because immediate response to large-scale epidemics or containment of contanimated water supplies in extreme situations (catastrophic medicine) is critical, the ability to confirm the presence of a pathogen or virus rapidly and precisely is very important. Forensic science Since the first landmark US case of PCR-based genetic analysis in 1986 by the lab of Henry Erlich, PCR has vastly improved police ability to confirm or exonerate suspects based on their genetic code, which is as unique as a fingerprint. In contrast to the earlier techniques for comparing DNA using tissue samples found at a crime scene with samples from suspects, PCR can amplify DNA using miniscule amounts of biologic material, including, but limited to, samples of blood, semen, hair, or saliva. Enabled by PCR, forensic science today can establish a genetic fingerprint from biological traces from dental molds, cigarette butts, eating utensils, and licked envelopes. PCR has the additional benefit of providing results rapidly, usually within 24 hours, which enables police investigation to move forward quickly. PCR genetic analysis comparing forensic specimens with genetic profiles stored in a database of those previously convicted has solved a number of crimes without a known suspect. PCR genetic analysis has also been able to demonstrate the innocence of the wrongfully convicted in hundreds of cases. PCR can also be used to locate traces of marijuana or other illegal substances. The role of PCR in investigation was underlined by the U.S Justice Department’s prediction that by 2010 investigators will be using portable PCR instrumentation to characterize DNA at a crime scene. Archeology and developmental biology PCR has also become useful in some scientific disciplines not directly linked with molecular biology. For example, archeologists have found PCR effective for determining relationships between ancient civilizations and modern man. In addition, PCR can provide a new level of information about individuals from early history through genetic analysis of ancient tissue specimens, for example from mummies. Researchers can use PCR to correlate information from history, for example what the historic record says about a Pharaoh, to the facts apparent from genetic information. Evolutionary biologists use PCR routinely to chart the evolution of plant or animal species. In the ongoing study of human evolution and anthropology, PCR has helped clarify the genetic differences between Neanderthal man and modern man, which although far greater than the miniscule differences between modern individuals from different parts of the globe, are only half that of the genetic differences that separate us from our primate ancestor, the chimpanzee. Important inferences about human evolution can also be obtained by analyzing genetic differences among modern human populations. Food production and safety PCR is effective for analyzing the genetic information of the food we eat, in that it is able to differentiate between genetically modified plants and traditional plant species. In addition, PCR is highly effective in locating pathogens like Salmonella and Listeria in food as well as confirming water contamination, aiding the effort to improve food and water safety worldwide. PCR technology development Although simple, significant technological challenges had to be overcome before PCR could be used reliably and reproducibly. The newest forms of PCR respond to scientific and technical needs, for example, reverse transcriptase or RT PCR allows scientists to amplify RNA (Ribonucleic Acid) in the same way they copy DNA. Specialized enzymes enable the amplification of DNA strands that are several thousand bases in length; others produce amplification at a very high level of accuracy. A form of the technology that monitors PCR amplification in real time extends scientists’ ability to make truly quantitative measurements. Other technical advances include “hot start” systems and automatic cycling systems make DNA copying extremely specific and precise. As in other areas of the life sciences, PCR can also be miniaturized, making the technology even more accessible. The development of PCR technology today can be described as a continual process of overcoming the technical challenges with efficient solutions. Going ahead, PCR will be used to find genetic constellation that are susceptible or resistant to certain diseases. It will also help define which drugs and dosages will be optimal for us. For example, K-RAS is a gene that codes for a protein that plays an important role in the epidermal growth factor receptor (EGFR) pathway – a complex signaling cascade that is involved in the development and progression of cancer. The K-RAS gene is a defining factor in looking at whether a patient with colorectal cancer can benefit from EGFR inhibitors, a therapy which prevents growth signals from entering the cells, thus stunting the growth of the tumor. Patients with a mutated K-RAS gene (35-45% of metastatic colorectal cancer patients) do not benefit from certain EGFR inhibitors like Erbitux. Recent studies in non-small cell lung cancer have shown that some patients carry somatic mutations in the EGFR gene. These mutations may correlate with responsiveness to the EGFR tyrosine kinase inhibitors, with some mutations having a sensitizing effect and others being linked to resistance. More and more complex disease mechanism will be understood which are often polygenetic in nature. They will help us to screen high risk, prognosticate disease and optimize treatment, for eg, in various forms of cancer and metabolic disease. This can be done using PCR or microarrays. In few years from now, a genome would probably cost as low as $1,000, thereby facilitating individualized treatment and personalized healthcare with PCR technologies. This also will bring about better understanding of epigenetic phenomena, which represent modifications of the genetic sequences by methylation. Genomics will not only continue to develop into a routine technology but also a cutting edge tool to new areas of biology. ]]> <![CDATA[PCR Changes the World of Molecular Biology]]> https://biospectrumindia.com/news/95/8268/pcr-changes-the-world-of-molecular-biology.html https://biospectrumindia.com/news/95/8268/pcr-changes-the-world-of-molecular-biology.html Tue, 10 Mar 2009 11:35:00 +0530 PCR Changes the World of Molecular Biology PCR Changes the World of Molecular Biology Since its discovery, PCR has established itself as the most reliable technique that is accelerating biotech research and gaining prominence in almost all areas of life sciences. The discovery of polymerase chain reaction or PCR has forever changed the molecular biology world. It is an indispensable research technique capable of producing billions of copies of a DNA fragment from just few copies, in less than two hours and is used for a variety of medical and biological applications from basic gene sequencing, diagnosis of hereditary diseases, the identification of genetic fingerprints, the detection and diagnosis of infectious diseases to the creation of transgenic organisms. Following its invention 26 years ago, PCR has been adapted extensively for numerous molecular biology applications. Gene expression analysis by reverse-transcription quantitative PCR (RT-qPCR) has been a key enabling technology of the post-genome era. PCR is also the lone technique that helped the synthetic oligonucleotide business become a thriving industry today. PCR suppliers in India Players with direct presence Bio-Rad Eppendorf Roche Players with indirect presence ABI (Through Labindia) Bioneer (Krypton Biomedicals) Cepheid (Through Biotron Healthcare) Stratagene (Through Genetix) Takara (DSS Imagetech) Techne (Scientech, Carebio  medicals) The invention Kary Mullis, who earned a PhD in biochemistry from University of California, Berkeley in 1973, conceived PCR as a means to amplify a specific locus of interest on the human genome in 1983 . After conceptualizing PCR, Kary labored for a number of months to work out experimental conditions. Since thermostable polymerases were not yet available, it was necessary to add Klenow after each thermal cycle, adding to the tedium of development. There were many failures and many reasons why PCR should not work.  Ignoring the doubts of many, the scientist was able to perform his first successful experiment on December 16, 1983. A patent for PCR was awarded to Cetus Corporation, where Mullis worked when he invented the technique in 1983. The Taq polymerase enzyme was also covered by patents. Perkin-Elmer partnered with Cetus to commercially introduce a thermal cycler in the market. This platform was based on compressor driven refrigeration technology.  Few years later, pharmaceutical major Hoffman La Roche purchased the rights to the patents in 1992 and currently holds those that are still protected. Evolution of  technology As PCR introduced capabilities to identify, manipulate, and amplify DNA, research possibilities flourished. The detection of genetic mutations, the ability to detect the presence of previously unknown genetic material, as well as the ability to analyze degraded DNA, all became common practice. For example, diseases such as muscular dystrophy and HIV could be detected and diagnosed with the use of PCR. As scientists grew more familiar with the technique of PCR, they began to expand on the utility of the method. And there have been a lot of improvements in the technology, experimental design, and data analysis. During the late 1980s PCR was used to measure the quantity of DNA present in a reaction, generating the term “quantitative PCR” or more simply, q-PCR. This technique further improved PCR by the isolation of Taq Polymerase in the early 1990s. qPCR and, more specifically, real-time qPCR has become a routine and robust approach for measuring the expression of genes of interest, validating microarray experiments and monitoring biomarkers. The use of real-time qPCR has nearly supplanted other approaches like Northern blotting and RNase protection assays. PCR technology and method has today reached a mature stage of development and implementation.  This technique further improved PCR by the isolation of Taq Polymerase in the early 1990s. The heat stable polymerase could remain active through many cycles of heat required for amplification and created the demand for faster cycling. Russell Higuchi and associates developed a system to monitor the amplification of DNA simultaneously to the reaction. The system involved ethidium bromide, a thermal cycler to irradiate samples with UV light, and a camera to record fluorescence. “The introduction of Peltier-based temperature controlled blocks followed by the introduction of interchangeable blocks, multiple blocks, low reaction volume blocks, blocks with high ramping rates, and finally temperature gradient blocks led to global adoption of PCR. But, the most radical innovation in this space was the development of ‘real-time’ platforms that measure the amount of PCR product made at the end of each cycle. Real-time PCR platforms and the FRET- and SYBR Green-based chemistries enabling the same have become cornerstones of modern genomics, especially for gene expression and genetic analysis applications,” said Subramanian Dharmaraj, senior marketing manager, genomics division, Labindia. In the early 1990s, fluorogenic dual labeled probes were developed as a means to practice q-PCR. In conjunction with fluorescent probes, PCR had further evolved into a sensitive quantification tool useful for the detection of any desired genetic element. As a result, the ability to measure gene expression and practice genotyping quickly became trivial and widespread throughout the biotechnology industry. Now, with the recent development of new dyes and quenchers such as the series of Black Hole Quencher, CAL Fluor and Quasar dyes, the possibilities for PCR are seemingly endless. Market The real-time PCR market in itself has come a long way, since the introduction of the first commercial real-time PCR platform by Applied Biosystems. The focus has gradually changed from hardware to complete end-to-end workflow-based solution. Gradually, other players also started penetrating the market by introducing more user-friendly and flexible products. There are over 15 companies operating in this space globally. Applied Biosystems has the highest share of the market with Bio-Rad, Stratagene, Eppendorf and Roche being the other major stake holders in the basic research market. Additionally, Corbett, Cepheid and Techne are also trying to make inroads into this market. As further innovation in instrument technology has been slowing down over the last few years, one can expect that further growth in this market will be mainly driven by innovative reagents and consumables for the next few years. The use of molecular techniques in all segments of the clinical, diagnostic and testing markets has been growing by leaps and bounds over the last few years. This is the primary driver for the growth in the PCR market at present. Major players in PCR market in India include Applied Biosystems, Eppendorf, Bio-Rad, Stratagene, Techne, Corbett and Cepheid. Technology upgradations During the developmental stage of this product line, real-time PCR was perceived merely as an optical upgrade of conventional PCR. But as more sophisticated applications were enabled by the real-time PCR technique, instrument manufacturers also realized that the technique offered great potential and the need for rapid improvements in their platforms. As a result, hardware features including the light source, the detection systems etc. were rapidly upgraded to keep pace with the application development without diluting the cost to performance ratio. Innovative approaches such as virtual filters were also implemented to deconvolute complex fluorescent dye spectra thus achieving better signal to noise ratios. Even though, there are various real-time PCR chemistries available, two chemistries are widely used by the scientists all over. These are FRET-based TaqMan technology and SYBR Green chemistry which is dependent on SYBR Green’s ability to bind any double-stranded nucleic acid molecule. TaqMan chemistry is extremely accurate and highly specific and considered to be the gold standard for real-time PCR experiments. However, with proper optimization SYBR green based methods can also work well. Having sensed the need for speed and reliability, technology providers have started offering ready-made off-the-shelf assays, customized assays and optimized reagents enabling sample preparation from a wide range of specimens. As of today, the entire focus has shifted to provide complete work flow solutions to researchers. This has allowed scientists to focus on the science and discovery rather than the technique. The most recent and novel innovation in this area has been the adoption of the microarray format for running real-time PCR experiments. This format allows researchers to interrogate the expression level of hundreds of genes simultaneously. With increasing number of scientists wanting a much closer view of gene expression at the pathway and individual biological process level, which typically involves a few hundred genes, these real-time PCR based low density arrays have already become a very popular tool. These arrays are also becoming an incredibly powerful tool to analyze global gene expression changes in the entire miRNA gene set. The future of PCR remains bright as the technology becomes more rapid, cost-effective, easier to use, and capable of higher throughput. Jahanara Parveen ]]> <![CDATA[Gene Sequencing Fulfills Multiple Needs]]> https://biospectrumindia.com/news/95/2305/gene-sequencing-fulfills-multiple-needs.html https://biospectrumindia.com/news/95/2305/gene-sequencing-fulfills-multiple-needs.html Tue, 10 Mar 2009 10:35:00 +0530 Gene Sequencing Fulfills Multiple Needs Sequencing technology has intensified the mapping of human genome and brings humanity closer to understand the molecular mechanisms of life. Years after the introduction of the first gene sequencer, gene sequencing technology has played a vital role in enhancing modern molecular research. The completion of the Human Genome Project (HGP) marked the end of ‘the first half of genetics’. Armed with a reference sequence of 3.2 billion bases of DNA, the scientific community has at its fingertips a priceless resource that could change the face of biomedical research and medicine. The free availability of reference sequence raised a host of crucial questions like, what genetic variations are associated with evolution of mankind? Which genes are associated with complex genetic diseases? What does genetic variation tells us about ethnic susceptibility to drugs and diseases? What is the function of the vast stretches of non-coding or junk DNA? The scientific community across the world quickly realized the need for a paradigm shift in DNA sequencing technology to address these and many other questions. After all, by most estimates, the HGP consumed 13 years and $2.7 billion to map the human genome. It was impossible to reproduce these efforts every time when scientists make an attempt to solve the most complex puzzles in medical science; unless it can be done much faster at really affordable cost without compromising the accuracy. Next generation sequencers Predictably, the entry of next generation sequencers will have a significant impact in the market. However, the ability of these platforms to enable novel sequencing applications apart from de novo sequencing remains to be seen. Therefore at least for the next few years, market dynamics in the context of technology development is much less predictable. It would be reasonable to expect further fragmentation of the market, with ultra high-throughput technologies competing to become the de facto sequencing standard. Roche/454’s Pyrosequencing-based GS 20, AB’s solid platform based on sequencing by oligos ligation and detection technique, and Illumina/Solexa’s Illumina genome analyzer platform are the three most highly successful products in this space in India. In India, DNA sequencing technology is well-adopted and employed in almost all the areas of life science research. Being the inventor of the first automated DNA sequencer, Applied Biosystems (AB) dominates the Indian market with its market share thought to exceed 90 percent followed by other players like GE, Amersham, Beckman and Licor. A mighty technology The DNA  and protein sequencing technology has revolutionized genomics by allowing rapid automated sequencing of genes.  Development in DNA sequencing technology has provided  unprecedented insight into the entire collection of genome transcribed sequences. Without this technology, the progress that led to the biotechnological production of enzymes, active agents as well as antigens for vaccines would not have been possible. The introduction of gene sequencer has extensively accelerated the pace of biological research and various discoveries. The quick pace of sequencing is achieved by employing sophisticated modern DNA sequencing technology.  The technology has helped scientists to generate the complete DNA sequences of many plants, animals and microbial genomes across the globe. The success of the human genome project has led to rapid advances in the life science industry. DNA sequencing technology has shown promising results in treating pathogenic infections such as HIV and hepatitis virus, as well as other ailments; and is also gaining prominence as it offers a ray of hope for those afflicted with genetic disorders. The extensive data from protein and DNA sequencing experiments have provided scientists with a wealth of information that forms the basis for the investigation of cellular processes. Towards the end of their research and development efforts, pharmaceutical companies seek to deliver safe and efficient molecules. With tremendous technological developments happening in protein and DNA sequencing, pharmacogenomic approaches have benefited from the availability of the human protein sequence, which provides clues to describe genetic networks and may ultimately initiate new ways of developing compounds. The availability of the human protein sequence, together with the pharmacogenomic and pharmacogenetic approaches, is expected to contribute to a better selection with a faster development of safer and more effective drugs. Genesis of technology The genomics revolution that reached its peak point owes its very existence to two men. The first is Frederick Sanger, who in 1977 developed the method for DNA sequencing. The second is Leroy Hood, who with colleagues Michael Hunkapiller and Lloyd Smith, at the California Institute of Technology (Caltech) in 1986 developed the key technology behind the DNA sequencing machines and the reagents needed to run them. The DNA sequencing machines are now marketed by Applied BioSystems. Sanger’s enzymatic approach relies on specially modified reagents (2’,3’-dideoxynucleotide triphosphates) whose incorporation into a growing DNA strand terminates the extension reaction. The method calls for extending a primer-template pair in the presence of a radioactive marker and, in four parallel reactions, either dideoxy-A, dideoxy-C, dideoxy-G, or dideoxy-T. The resulting products can then be resolved on a high-resolution polyacrylamide gel to produce a four-lane-wide ladder that reveals the template’s sequence. Brilliantly inventive, the technique is also laborious, producing a few hundred or perhaps a thousand bases at a time, which then have to be read by hand. Hood’s invention, the automated DNA sequencer, simplified the process of sequencing developed by Sanger by replacing the radioactive marker with safer fluorescent ones. That first system, marketed by Applied Biosystems could produce 4,800 bases of sequence per day.  Today, some companies still market systems based on this design. But the polyacrylamide gel of Hood’s first foray for the most part has been replaced by arrays of tiny capillaries, each of which acts as a lane from an old-style gel. Technological development The general methodology has changed relatively little since the introduction of the first protein sequencer. However the use of automated equipment to perform multiple cycles has greatly improved the efficacy of  sequencing. Automated protein sequencing is considered as a major development in the field of  biotechnology. Optimization has allowed the determination of extended sequences of very low abundance proteins. Much effort in recent years has been devoted to improve the sensitivity of protein sequencers by using new, highly sensitive methods for identifying amino acids. A large number of upgraded, automated and sensitive DNA sequencing machines continue to enter the market at a much cheaper cost. Over the last decade significant improvements have been made to DNA sequencing technology. Some of these landmark improvements include shifting from radioactively labeled nucleotides to more safe fluorescent dye labels as well as the move from slab gels to capillary electrophoresis (CE) based analysis. Even entry-level DNA sequencing platforms currently available in the market completely automate all the sequencing tasks that were time-consuming and laborious. The processes like filling the capillary with gel, sample injection, electrophoresis, real-time detection of labeled DNA strands and converting raw data into analyzed data are now automated. This allows researchers to focus on discovery instead of spending time on the technique itself and downstream data analysis. Further advancements include increased throughput, widely accepted standards for internationally acceptable data and significant reduction in ‘per sample’ cost. These advancements have resulted in the development of increasingly versatile applications, genotyping, SSCP and methylation studies to name a few. The development of more efficient and easy-to-use consumables and efficient sample preparation kits are now a focus area for all the major players in the market.   Jahanara Parveen ]]> <![CDATA[Pfizer-Wyeth now a premier biopharma entity]]> https://biospectrumindia.com/news/95/4657/pfizer-wyeth-now-a-premier-biopharma-entity.html https://biospectrumindia.com/news/95/4657/pfizer-wyeth-now-a-premier-biopharma-entity.html Wed, 04 Feb 2009 14:14:00 +0530 Pfizer-Wyeth now a premier biopharma entity The Pfizer-Wyeth deal has created ripples in the biopharmaceutical market as a marriage between the two giants could mean capturing a major chunk of the  total market share. But it has failed to create much spark in India Major Products Pfizer Brands Corex Becosules Gelusil-mps Dolonex Minipress-xl Wyeth Brands Folvite            Ovral-l            Mucaine            Wymox              Wysolone           It could never get bigger than this as two big-wigs of the pharma industry decided to join hands, making this the fourth largest acquisition in the history of the pharmaceutical industry. The Pfizer-Wyeth deal has come in as a blessing in disguise just when the pharmaceutical industry had mentally geared  itself up for the death of “the Big-Pharma” said industry experts. The $68 billion acquisition  of Wyeth could perhaps be the much awaited tonic for Pfizer which was gearing itself up for a nose dive drop in its revenue streams  in the event of two of its major Blockbuster drugs  namely cholesterol drug  Lipitor and its erectile-dysfunction drug,Viagra, going off patent in a couple of years. Laws suits and legal battles in different countries including the infamous Ranbaxy-Pfizer Lipitor suit, coupled with depleting R&D product pipelines and pressures of global financial crunch were some of the predicaments. “Even before the recession, Pfizer has been looking out for acquisitions to increase its product base and diversify its business. It was a company which did not have a diversified portfolio and  was just dependent on a handful of drugs,”commented a reliable source under the condition of anonymity. Altogether there are 14 patents which will go off patent leading to a lose of around $35 billion. Globally the New York based pharmaceutical giant had also showed a dip in its performance over the past one year. It declared a 4 percent drop  in its revenue in its current quarter. The deal and the global consequences According  to the terms of the deal, each outstanding share of Wyeth will be converted to $33 in cash and 0.985 of a share of Pfizer stock, valued at $17.19 per share. The acquisition will be financed through a combination of cash, debt and stock, with banks providing $22.5 billion in debt. Analysts estimate that Pfizer has $25-30 billion in cash, much of it kept offshore. At the time when news of  the deal was doing the rounds, Pfizer halved its dividend to go ahead with the deal which did not go down well with the investors. There was an immediate drop of 10 percent in Pfizer’s shares.  In the case of Wyeth however its share price increased by 14 percent Though it was not an acquisition out of a desperate urge but at the same time Pfizer had no choice. A large scale acquisition was bound to happen sooner or later. Nandakishore K, industry manager, health care practice, Frost & Sullivan, said, “Pfizer’s dependency on one drug is huge. A merger will bring about a consolidation in its market position not just in the purely pharmaceutical space but in diversified areas like vaccines, animal health, and biologicals.” The deal will increase Pfizer’s revenue by 50 percent. “Wyeth’s product portfolio includes the more non-traditional areas of pharmaceuticals which in a way compliments with that of Pfizer (which focus on niche areas like oncology, antibiotics). A nexus will give them a wider base,” said Ajit Mahadevan, partner advisory services, Ernst & Young. About 12 percent of Wyeth’s revenues comes from consumer healthcare, 5 percent from from animal health and 36 percent from biologics. At present, Pfizer has a product pipeline which includes clinical trials for Sutent (oncology), 10 phase I programs whose mechanisms has not yet been designed (for oncology). In the same therapeutic segment, Wyeth’s products include clinical trials like Posutinib (for diseases like breast cancer) and  Inotuzumab. Pfizer has two Phase II and one Phase I trials in Alzheimer while Wyeth has five Phase I programs in this segment. With this deal, Pfizer can now take under its fold, Wyeth’s biological and vaccine product portfolio thus diversifying itself in the biotech space. In a joint statement given by both the parties it was specified, “This combination means a broad portfolio of health care solutions and treatments for every stage of life; leadership positions in key therapeutic areas such as cardiovascular, oncology, women’s health, CNS and infectious disease; in vaccines, biologics and small molecules; and in animal health, with products for companion animals, biologics and anti-infectives. A robust pipeline of biopharmaceutical development projects, including programs in inflammation/immunology, oncology and pain, as well as a significant opportunity to find a cure for Alzheimer’s disease.’ The joint press release also mentions, “Industry-leading positions in most of the world’s developed countries and an enhanced geographic presence in key emerging markets such as China, Latin America and the Middle East that will enable treatment for patients around the world. The bad news is that the merger might lead to huge scale job cuts and layoffs (especially with Pfizer emphasizing on its cost saving measures). Already there have been rumors doing the rounds that globally jobs amounting to 20,000 might be cut if the drug maker has its way. Pfizer  has already fired thousands of people. Most recently it cut 800 researchers and 2,400 sales personnel. A Wall Street Journal mentions, ““If completed, a deal could create billions in cost savings through the combination of back-office operations, research and development, sales and manufacturing.” Step one will be  hashing out the chaff from the grain. India performance Despite the escalated hype globally, the deal will have minuscule impact on Indian shores. “I do not think it will have much impact on the Indian scenario. They have a small share in the market and the biotech in India has not yet started. So the deal will not make a difference,” revealed the CEO of a well known global pharmaceutical giant. A sneak peek at both the companies’ ranking and performance in India will reveal that unlike the global platform wherein Pfizer’s ranking is number one and Wyeth coming within the Top 15 (according to IMS rankings), in India Pfizer falls withing a ranking of  18 while Wyeth does not even figure within the top 30! “According to ORG IMS, the Indian market share for Pfizer comes to around 2.2 percent while that of Wyeth comes up to 0.8 percent so together their market share would be 3-3.5 per cent,” added Nandakishore. A reliable source also mentions that Pfizer’s retail sales amounts to $134 million (market cap of $329.68 million)  while Wyeth’s sales rake up to $69 million (market cap of $201.66 million). The combined retail sale revenues will increase to approximately $198 million.  The plus point will be broadening of its product portfolio. “Vaccines are the next big thing in the biopharmaceutical market. Wyeth has Prevnar vaccine for children which has been churning out good revenues in India,” added Nandkishore. Pfizer which sold out its OTC division to J&J  few years back is back in the grind again. “Wyeth has a consumer healthcare division in India and with this Pfizer will have its foot set again in that space,” added Mahadevan. The global press statement also mentioned that the merger intended “to streamline manufacturing capabilities and increase their outsourcing activities’. To this Nandakishore added, “Both Pfizer and Wyeth have a good share in the CRAMS this may but give a boost to the CRAMS market in India.” “Many Indian arms of global MNCs  have not aligned their products to the global platform now we can see launching of products in India which will align itself globally,” added Mahadevan. As  far as speculations on the job losses in India are concerned spokespersons from both the companies refused to comment. However if one looks back in retrospect, when the financial crunch hit the market, globally Pfizer had cut down on 10,000 jobs but in India they were in the process of recruiting people . “India has become a key hub for most of the MNCs so job cut is unlikely,” said a reliable expert. In India, Pfizer employs around 2,000 people while Wyeth has a workforce of 800 plus. The acquisition has come at a time when most companies across all sectors were hesitant to go in for an M&A. The credit crunch has made access to easy capital difficult and usually post a deal even the integration process might not be a cakewalk. So says conventional management concepts. “Big pharma has a good amount of cash available. Their average debt will be only around 6-7 per cent. Integration depends all on the expertise on the management,” points out Mahadevan. One can hope to see a new wave of M&As  which will be in the same league as this deal, as some of the top pharma companies are already in talks  with parties. The Pfizer-Wyeth deal  this can set a new trend of M&A not just globally but can be a lesson for Indian companies too. Nayantara Som in Mumbai  ]]> <![CDATA[â€œPCR has become the cornerstone of modern molecular biologyâ€?]]> https://biospectrumindia.com/news/95/6240/pcr-has-become-the-cornerstone-of-modern-molecular-biology.html https://biospectrumindia.com/news/95/6240/pcr-has-become-the-cornerstone-of-modern-molecular-biology.html Wed, 04 Feb 2009 13:16:00 +0530 “PCR has become the cornerstone of modern molecular biology” —Dr Carl Wittwer, Professor of Pathology, University of Utah Medical School, Salt Lake City, Utah, USA Polymerase Chain Reaction (PCR) is a method that allows exponential amplification of short DNA sequences (usually 100 to 600 bases) within a longer double stranded DNA molecule. First discovered in 1983, PCR has now become a common and indispensable method that researchers and scientists use in research labs for a variety of different applications. From its initial application in DNA amplification and genotyping, PCR is now applied to fields such as forensics, archaeology and even in food and beverage industries. A decade old, the Roche LightCycler 480 system is one that has been widely used in research labs worldwide. Since its invention, the LightCycler system has evolved into a sophisticated system that comprises five excitation channels and six detection channels, where researchers can observe and track the progress of experiments in real time to ensure that they get an improved PCR result. In an email interview with BioSpectrum, Dr Carl T Wittwer, the inventor of the LightCycler system, shares his views about the evolution of the system and where he sees PCR progressing in the next decade. Professor of Pathology at the University of Utah Medical School, Dr Wittwer developed rapid-cycle PCR techniques for DNA amplification in the early 1990s and adapted flow cytometry optics to thermal cycling for the read-time monitoring of PCR in the mid 1990s. What are the major breakthroughs achieved with PCR over the last decade? PCR has enabled many breakthroughs in research and clinical medicine. The ability to amplify and duplicate genetic material within a very short period has made it possible for researchers to unravel the human genome and understand infectious and hereditary diseases. For example, with PCR we have been able to understand genetic contributions to Parkinson’s disease better over the last decade. Previously unsuspected genes have also been discovered that contribute to acute myeloid leukemia, a particularly deadly form of leukemia through PCR. Over the years, many variants of PCR have been developed. One of them is quantitative real-time PCR, more commonly know as qPCR. With qPCR, the exponential phase of PCR is monitored, allowing determination of the initial amount of target. The contributions of real-time PCR systems are now indispensable in the research lab. PCR technology today is being applied across different industries and fields of study, including forensic science, virology, food microbiology and even environmental monitoring. Roche provides research laboratories all over the world with a series of different real-time PCR systems to suit their needs. With the LightCycler 2.0 and LightCycler 480 real-time PCR systems, researchers have access to both rapid carousel-based and high-throughput systems. The LightCycler introduced many “firsts” to real-time PCR, including rapid cycling, SYBR Green I, dual hybridization probes, single hybridization probes, and melting analysis. As a rapid, open system, it remains the most user-friendly real-time instrument for assay and technique development. The first genetic tests to receive FDA approval in the US (F5 and F2) were on the carousel LightCycler in 2002, setting the standard for other companies to follow. The extreme sensitivity of real-time PCR, with the ability to detect even a single nucleic acid molecule, makes it possible to detect fetal DNA in maternal serum for noninvasive prenatal diagnosis. Digital PCR is a recent modification where the sample volume or concentration is reduced so much so that each reaction only contains one starting template. Emulsion PCR creates millions of nanoliter PCRs within oil, a process that is central to most next-generation sequencing methods. Who are the major players in real time PCR systems? What is the current market size of real time PCRs (number of PCR systems sold per year?) Roche introduced the LightCycler in 1998, the first system to automate absolute quantification and display PCR in real-time as the reaction progresses. To date, over 7,000 LightCycler systems have been sold. The market size for real-time PCR continues to expand in research and medical diagnostics. Based on rapid cycle PCR, carousel LightCyclers can complete PCR in 15-30 minutes, providing rapid turn around for critical clinical settings and sequential research. In situations where high throughput is more important than turn around time, the LC480 allows amplification on 96 or 384-well plates. A 1536-well LightCycler (again a first in real-time PCR) will be introduced in 2009. What are the factors that drive PCR evolution? The need for speed, accuracy and cost containment are factors that drive PCR evolution. Initially, finding a polymerase that withstood the high temperatures involved in the duplication of DNA was critical. The discovery and usage of the heat-resistant Taq polymerase in 1988 greatly revolutionized the PCR technique by allowing automated temperature cycling without reagent addition. The process of PCR suddenly became much simpler and more accessible. However, quantitative data was still difficult to obtain, and the process remained qualitative until the introduction of real-time PCR instruments in the mid 1990s. By monitoring fluorescence each cycle of PCR, the precise amount of starting template could be determined, allowing true quantification. Quantification was critical for mRNA quantification in research and viral load determination in clinical applications. Time consuming and expensive microbial diagnostics began to be replaced by faster, more accurate real-time PCR assays. The next advance was melting analysis, a process that goes beyond conventional real time PCR. In addition to monitoring fluorescence once each cycle, fluorescence is monitored continuously as the temperature changes so that hybridization can be followed.  Both PCR product hybridization with SYBR Green I and probe hybridization for genotyping can be monitored at the end of PCR. As melting technology became better and better, high resolution melting analysis was introduced as the latest method for product analysis. Labeled probes were no longer necessary for genotyping and entire PCR products could be scanned for single base changes in only one copy of diploid DNA. The LightCycler real-time PCR systems are a good example of how the PCR technique has evolved. The LightCycler 1.5 real time PCR system was the first to monitor the hybridization process through melting curve analysis and automate absolute quantification. The LightCycler 2.0 system advanced multicolor analysis to provide researches with up to six colours of analysis. As real-time PCR evolved and high throughput analysis became more important, Roche developed the LightCycler 480 system to accommodate both 96 and 384-well microtiter plates. The variable plate formats available on the LightCycler 480 meant that scientists could exchange thermal block cyclers in a few minutes without having to recalibrate the instrument. What will be the future for PCR in the next decade? PCR will become faster, more precise, and more affordable with lower sample volumes. For most applications, 5-10 min PCR is feasible. Unlabeled probes will replace labeled probes. High resolution melting will expand into additional applications such as sequence matching for transplantation testing. The flexibility and wide application base of PCR are difficult to beat. For specific applications, alternative technologies will excel. For example, arrays for copy number variations are very powerful, and provide data that is difficult to obtain by PCR alone. However, PCR has become the cornerstone of modern molecular biology. It will be with us forever. Narayan Kulkarni in Singapore ]]> <![CDATA[Transgenic Bt technology]]> https://biospectrumindia.com/news/95/6170/transgenic-bt-technology.html https://biospectrumindia.com/news/95/6170/transgenic-bt-technology.html Wed, 04 Feb 2009 13:00:00 +0530 Transgenic Bt technology -C Kameswara Rao Foundation for Biotechnology Awareness and Education, Bangalore, India pbtkrao@gmail.com Transgenic technology, involving a wide range of pesticidal genes from the bacterium bacillus thuringiensis (Bt), dominates the scenario of agricultural biotechnology. At the same time, Bt technology is also the most focused target of vehement anti-tech activism.   While the terms Bt cotton, Bt corn, Bt potato, etc., are familiar, the level of understanding of what the technology actually means, what it can and what it cannot do, is very poor.   A variety of issues such as the biology of bacillus thuringiensis, its proteins, use of Bt as a biopesticide, transgenic Bt crops, benefits and limitations of the technology and biosecurity, are important components of public awareness.   Bacillus thuringiensis Bt is a rod shaped, gram-positive, soil bacterium, discovered in 1901.  Bt is among the most thoroughly studied bacterial species of agricultural importance, its diverse aspects having been researched for over a century.   The book ‘Bacillus thuringiensis: Biology, Ecology and Safety’ (T.R. Glare and M. O’Callaghan, 2000, John Wiley) refers to over 8,000 research publications by over 10,000 biologists, in over 60 years, and deals with most of the issues raised against the use of Bt.  Ignorance of this and other subsequent publications on Bt or a deliberate indifference to them, led to a much exploited misunderstanding of Bt technology. Concept of Bt The term Bt now refers to not a single simple species entity, but to a large group of subspecies and varieties, based on over 60,000 isolates, collected from all over the world.   There are more than 80 serologically characterized (using specific antibodies) types of Bt. The controversy about distinguishing Bacillus thuringiensis from the related pathogenic Bacillus cereus and Bacillus anthracis was adequately addressed (de Maagd, Bravo & Crickmore, July 2005).   When types of Bt can be identified serologically, a microbiologist can certainly distinguish the three species.   Bt in nature Bt is a universally occurring soil bacterium, isolated from several thousand soil samples from 80 different countries. It commonly occurs also on the aerial parts of plants such as leaves and on even washed fruits and vegetables we consume. It may be present in water, possibly as a wash off from the soil and plant surfaces.   Bt may be transported in the atmosphere, as inferred from its presence deep in the polar ice cap. Bt grows and competes, but poorly in soil.   Bt or its proteins may persist for about 100 days in soils, for 24 hr in running water and for 12 days in stagnant water bodies.  Bt seems to require an association with plants and insects to perpetuate for longer periods in nature. Bt as a biopesticide Bt produces a wide range of insecticidal proteins that have been in use in pest control since 1938. There are about a 100 biopesticides exclusively based on Bt and over 90 per cent of commercial biopesticides, used even in organic farming, contain Bt.   Bt proteins and their encoding genes Bt produces a large number of proteins that are toxic to specific insect groups under specific conditions.   Bt also produces a) several enzymes, b) some compounds that lyse erythrocytes, and c) some that are enterotoxic to vertebrates. Bt toxins are produced either within the bacterial cell (endotoxins), or on the cell surface (exotoxins).   More than 170 toxin-encoding genes have been isolated form Bt collections. Among the endotoxins, the insecticidal crystalline proteins, called the delta-endotoxins, are significant in Bt technology.  The crystalline proteins are described para-sporal, as they are co-produced and co-exist along with spores (the means of bacterial propagation), in the bacterial cells.  When the bacterial cell lyses to release the spores, the crystalline proteins are also routinely released into the soil.   The names of the genes that encode the crystalline proteins are prefixed with ‘Cry’, as for example Cry1Ab, Cry1Ac, Cry9c, etc., and the proteins that are encoded by these genes are ‘Cry’ proteins.   The non-crystalline endotoxins are prefixed with ‘Cyt’. Pest specificity of Bt toxins Bt proteins are per se not toxic. To function as toxins Bt proteins require a specific set of biochemical and biological parameters which are available for different Bt proteins only in specific insect groups, which makes Bt toxins insect group specific. Cry1Ac and Cry2Ab control the cotton bollworm, Cry1Ab controls corn borer, Cry3Ab controls Colarado potato beetle and Cry3Bb controls corn rootworm. The Bt genes that are incorporated into different crops are specific to moths and butterflies (Lepidoptera, having wings covered by scales).   Pre-requisites for pesticidal activity of Bt proteins The following conditions are essential for an effective insecticidal activity of the Bt proteins: The pest must take a few bites of the plant tissue; Bt transgenics are not effective against sucking pests (Homoptera, with wings without scales), as they do not ingest plant tissue. An alkaline environment (pH 9.5 and above) in the gut of the insect pest is essential for the Cry proteins to dissolve in the gut fluids and to be converted into an active molecule to function as an insecticidal compound (mammalian stomachs are highly acidic). The pest specificity of different Bt toxins depends upon the presence of appropriate receptors, in the lining of the mid-gut (brush border) of the pest, which are absent form some pests, as evidenced by different Bt proteins being toxic to specific pest species.  The toxin binds to the receptors and causes disturbance in the integrity of the gut wall, leading to leakage of the contents, followed by starvation and death of the pest.   Fundamentally, the alkaline gut environment and the presence of an appropriate toxin binding receptor are crucial for insecticidal activity of Bt proteins. Basing on such requirements, the genes that encode pest specific toxins are chosen for developing different transgenic crops. ]]> <![CDATA[Can Asian companies really score?]]> https://biospectrumindia.com/news/95/2460/can-asian-companies-really-score.html https://biospectrumindia.com/news/95/2460/can-asian-companies-really-score.html Wed, 04 Feb 2009 12:50:00 +0530 Can Asian companies really score? -Mark Ravera is principal at US-based Strategic Pharma Consulting Group, which provides advisory services to both emerging market and western biopharmaceutical companies. This work makes him a frequent visitor to Asia. The big global pharmaceutical companies have spent large amounts of time and money fighting challenges from generic competitors. They have met challenges, both legal and regulatory, with very vigorous defenses. So, it is very surprising to note that several of the leading global players, including AstraZeneca, Merck and Eli Lilly, are looking to move into the biosimilars space. Novartis, already a strong generics player through its Sandoz division, is also expected to join the game. It appears that these companies view the biosimilars market as being very different from the small molecule generics market. And they may be correct. The big pharma companies are saying that they can leverage both their clinical development and manufacturing expertise to make their biosimilar efforts successful. But there is another expertise that they can use in this area, and this expertise may be the largest threat to Asian companies that have been investing in the biosimilars area—marketing. Asian pharmaceutical companies can claim that their biological manufacturing expertise is equivalent to that of the large US and European pharmaceutical companies, and this claim is, in many cases, valid.  Asian companies can also claim clinical development expertise, although to a much lesser extent in the more regulated markets. But it is very difficult for any Asian pharmaceutical company to claim an ability to brand and promote drugs in the US and Europe that is in any way equivalent to the branding and promotional abilities of the largest pharmaceutical companies. And this is a key component of the biosimilars market that has been overlooked—the importance of marketing. This will not be a “classic generic drug” market. There will be many questions and concerns regarding the safety and efficacy of biosimilars as compared to the original drugs, questions and concerns that will be emphasized by originator companies such as Amgen and Genentech. These issues will be raised with patients, prescribers, regulators and third-party payers. Given recent concerns surrounding drug safety and quality, and given that many of these biologicals are used by patients with very serious and/or complex diseases, it is reasonable to expect that those biosimilars with the Novartis or AstraZeneca names on the label will engender much more confidence as compared to biosimilars with the names of Asian companies that most people in the US and Europe have never heard of. This is not to question the quality of biosimilars coming from Asian companies—let us assume that, by all standards and metrics, the Asian biosimilars will be equivalent to those from the US and European companies. But the marketing power and brand equity of companies such as Merck and Eli Lilly will give them a clear advantage over Asian brands. It is important to remember that the biosimilar market is expected to be relatively high-priced. As a result, the western pharmaceutical companies will have gross margins on their products that could allow reasonable marketing and promotional efforts to address any concerns about their products. Of course, these are still early days, and we really don’t know how the biosimilar market will evolve. As of now, it looks like it may be a hybrid between the branded and generics markets. If this is the case, then both the large western companies and the Asian companies that want to compete in this space will have a lot to learn, and perhaps a lot to teach. ]]> <![CDATA[â€œLife-saving technologies are blocked from reaching the farmersâ€?]]> https://biospectrumindia.com/news/95/2743/life-saving-technologies-are-blocked-from-reaching-the-farmers.html https://biospectrumindia.com/news/95/2743/life-saving-technologies-are-blocked-from-reaching-the-farmers.html Wed, 04 Feb 2009 12:33:00 +0530 “Life-saving technologies are blocked from reaching the farmers” —Prof. Marc Van Montagu, founder, Institute of Plant Biotechnology for Developing Countries (IPBO) and president, European Federation of Biotechnology (EFB) The Belgian molecular biologist Prof. Marc Van Montagu is the founder of the Institute of Plant Biotechnology for Developing Countries (IPBO). Along with his colleague Prof. Jeff Schell, Prof. Marc Van Montagu discovered the gene transfer mechanism between agrobacterium and plants, which resulted in the development of methods to alter agrobacterium into an efficient delivery system for gene engineering in plants. He developed plant molecular genetics that includes molecular mechanisms for cell proliferation, differentiation and response to abiotic stresses (high light, ozone, cold, salt and drought) to develop transgenic crops resistant to insect, pest, and tolerant to novel herbicides. Prof. Montagu is also the founder of two successful biotech companies—Plant Genetic Systems Inc. and CropDesign. He is the president of the European Federation of Biotechnology (EFB) and a board member of the Indian biotech company Avesthagen. Here are the excerpts from the exclusive interview with the Father of Genetic Modification of Crops,  Prof. Marc Van Montagu: Genetically modified organisms (GMOs) are readily accepted in drugs and medicines. But why is there so much of opposition when it comes to GM food crops? Biotechnology is used in almost every product that improves our daily lives, which includes discovery, design and production of life saving drugs and detergents we use in our washing machines; GMOs are one such biotechnologies that are used in the manufacture of these products. Over the last 12 years, genetically modified maize, soybean, cotton and canola are readily accepted by farmers worldwide. The increased productivity of these GM crops has allowed the prices of the commodities to remain within reasonable limits, to the benefit of consumers. Farmers have understood the benefits of genetically engineered crops. The resistance of GM crops to insect pests or its tolerance to environmentally safe herbicides is giving direct benefits to the farmers in terms of higher yields or reduced application of pesticides. Scientific evidence from the farming communities in China and South Africa, who have adopted insect resistant cotton, has shown that there are direct health benefits linked with lower exposure to pesticides.  At the same time, these small farm holders have had more time to spend in off-farm activities, and so the benefits are multiple.  A significant benefit to the environment through lower use of pesticides and herbicides has also been demonstrated.  For example, the adoption of herbicide tolerant soybean varieties has allowed farmers in the USA and Argentina to follow the practice of no-till agriculture that reduces the amount of carbon released to the environment and helps sustain soil integrity, which is vital for the future of food security. We continue to see evidence of further benefits to farmers, food security and the environment, as each year passes many acreages of land are used for genetically modified crops. Another reason why society has been more cautious in accepting GM crops is that there is opposition to the so called ‘control of the food chain by multinationals’. This is a flawed perception since it is not the seed producers who control the food chain, it is the food and drink retailers who reap the major profits in this sector —and it is these same food and drink companies who own the major organic brands in the US.  So there is little basis for this argument.  To a larger extent, it is the global seed companies who hold the bulk of the GM technologies in the market today. This is because of the fact that the regulations and the costs of bringing a GM crop to the market can only be met by the multinationals. This is arising from the continued opposition to the introduction of GM crops, and means that no public sector organization, third world country or SME can afford to develop this technology beyond the stage of confined biosafety and performance trials.  As a result of this confusion, we are seeing brain drain in Europe, stalling of promising new crop varieties (such as drought and pest resistant crops or bio-fortified staple crops that are of relevance to the developing world), and a reluctance among investors to promote an SME culture, which are all vital components of the global knowledge-based economy. It is assumed that genetic engineering in food crops will revolutionize agriculture and eradicate malnutrition and hunger. How can plant biotechnology help the developing countries? There have been many endorsements of GM crop technology – as a vital instrument for meeting food security, developmental and environmental objectives over the years by authorities at the highest level, including the UN FAO, WHO, OECD, World Bank, and from over 25 Nobel Laureates. There is therefore a very strong support, drawn from a very diverse spectrum of opinion makers committed to finding sustainable solutions through innovation of agriculture for the very complex challenges facing society and the environment on which we depend. Environmentalists on the other hand express concerns over the sustainability of world agriculture and food security in the next 50 years if we are to continue with a ‘business as usual’ approach. Investments in science and technology for agriculture have repeatedly brought immense returns in crop productivity and are widely recognized as a vital instrument for the development, particularly for the rural poor, who represent 75 percent of the world population. In the 1980s, Overseas Development Aid (ODA) for agriculture stood at 16 percent, when the successes of the green revolution were still fresh in the minds of investors. Today, ODA for Agriculture stands at only 3.8 percent, and this will not change unless agriculture is brought rapidly back on to the world political agenda.  It is to be hoped that the food crisis of 2008 should serve as a wake-up call for policy makers to re-evaluate the potential that lies in present crop improvement pipelines, and to find measures that fast-track the approval of technologies that have the potential to invigorate agriculture for development. Biotechnologies, including GM crops coupled with modern breeding techniques and improved rural infrastructure are a coherent answer to many of the challenges we face for the sustainable production of food, feed, fuels and fiber.  It is absolutely essential that all of the major scientific breakthroughs we are seeing today in terms of improving yield, improving the nutritional content of staple crops and  drought tolerance are made available to the people who need them the most. Scientists have a responsibility here, better international R&D networks need to be established to support the scientists in developing countries who understand the local problems, but who lack access to the knowledge and technologies that the technology proficient countries possess.  Existing models of technology transfer are clearly failing, and new vision for global interaction is urgently needed. GM Crops still face a lot of resistance from public, politicians and more specifically many groups of activists. What would you tell those people who say GM Crops shouldn’t be allowed? There are absolutely no scientific grounds for the position that the activists have taken. They present alarmist arguments like there are health risks, damage to the environment and loss of biodiversity. The truth is however, more reassuring.  Firstly, the regulatory authorities, who oversee the research, testing and development of these GM plants, backed by national and international legislations, have very stringent guidelines regarding biosafety.  Prior to the commercial release of a new variety, several biosafety criteria have to be satisfied to get the  authorization. These regulations are important for ensuring that there are no risks to the environment or human health. The activities of the national regulatory authorities such as the USDA-APHIS or the European EFSA are highly transparent, and are readily available to the public for consultation through their databases published on the web.  As an example, there are repeated calls for moratoria on the release, including field testing of GM trees, based on the assumption that we know too little about the environmental impact of this technology. In response to this assertion, and to provide a scientific basis for discussions relating to the biosafety of GM trees under the Convention on Biological Diversity negotiations we carried out a study of what is known on this subject. We found that over 700 trials have been conducted worldwide since 1988 in over 35 species of tree, largely by public sector scientists, and often with environmental or societal rather than commercial objectives.  It is important that these facts are put in the hands of the policy makers so that any debate is properly informed and that the relevant scientific facts are first and foremost on the agenda. This is essential, since the demand for trees and forest products will continue to rise, and modern plantation forestry, including GM trees will be needed to meet this demand and alleviate pressure on the remnants of natural forests that are so vital for the environment and biodiversity. Therefore, rather than stall the testing of new varieties, we urgently need to see more testing, and that information regarding the biosafety, environmental benefits and performance of these plants should reach policy makers and society. Indeed, the only way in which the biosafety and performance of GM plants can be assessed is through controlled field trials—the same way as experimental new drugs are tested in clinical studies. We can no longer afford to stall progress given the magnitude of the challenges facing agriculture and food security. If the technologies presently under evaluation are stalled, we have to question what will happen to technologies such as drought resistance that must be brought to the farmers who will bear the brunt of climate change.  It is reassuring to see the impressive performance of GM drought tolerant wheat currently under evaluation in Australia.  Scientists are seeing a 20 percent yield increase compared to the best performing varieties over two seasons now.  This is exactly the sort of technology that has been so diligently developed and that could help stabilize grain prices and provide food security in the future.  It should be remembered that the recurrent drought in Australia and its impact on grain production has not only removed a staggering one percent from Australian GDP, it is one of the prominent causes of last years food price crisis.     Finally, the activists should really take a hard look at the ethics and morality of their untenable position.  Potentially life-saving technologies such as bio-fortified staple crops are blocked from reaching the farmers as a result of ‘biosafety concerns’ broadcast by a variety of organizations.  When one considers that malnutrition, rather than disease, is the single most important cause of disability and premature death, there should be no grounds for blocking technologies that have proven biosafety track records.  One can see parallels in the field of medicine where new drugs for ‘orphan diseases’ are fast-tracked by the regulatory authorities to ensure they reach those who need them the most. What is your opinion about the debate on the safety of genetically modified foods in India and other countries? Firstly, there is an established track record of risk assessment and supporting documentation established by the regulatory authorities in which GM crops are tested and commercialised.  The goal is to ensure that countries use common methods to collect consistent information for risk/safety assessments in their development of biotechnology regulations and guidance and that any information relating to the biology of an organism would be the same regardless of what the country’s regulatory system was involved. Secondly, there is a history of safe use of transgenic plants in thousands of trials and commercial planting around the world.  Thirdly, there is an established dialogue on appropriate data and safeguards for GM plants among different countries; organizations involved in their testing, and organisations such as the UN FAO are responsible for evaluating the relevance of new technologies for world agriculture.  The overwhelming conclusion from these different sources is that a case-by-case approach to GM crop regulation would be the sensible way to proceed, and this basic approach is officially recognized in the Cartagena Protocol for Biosafety. The consensus opinion is that the general methodology for science-based risk assessment set forth in the protocol is adequate and any debate on the issue of biosafety should be fact and science based. I would, however, like to take this opportunity to voice my concern over the present situation in India concerning the commercialization of GM (insect resistant) brinjal. It is clear that there is no debate on the real issues being of developing this variety.  It would appear that a well organized and well financed campaign of mis-information has been mounted to scare the public over ‘health risks’ associated with the consumption of this brinjal.  A number of points need to be made—the variety has been produced to provide resistance to an insect pest that ravages the 500,000 hectares of brinjal cultivated in India – using technology that has passed rigorous biosafety testing not only by the Indian GEAC, but also elsewhere around the world. It is ironic that questions regarding the safety of the technology (the Bt gene) are raised when the Bt protein (the same technology) is the most commonly used agent for insect control in organic agriculture for many years (90% of world organic insecticide used). At present, the only form of control of this insect pest is through the application of insecticides.  Insecticide spray is not an effective control, and for those farmers have to spray pesticide almost daily.  The most commonly used insecticide is endosulphan, a neurotoxin that is banned in most countries around the world because of the proven health risk to farmers and consumers. We have calculated that if the entire area of cultivation were sprayed at the present dosages, then the total annual cost to farmers would be in the region of $600 million per annum. If these farmers were to adopt the GM brinjal, they would firstly benefit financially since they would have to spend less on insecticide, but also they (and the consumers who buy their produce) would benefit through less exposure to dangerous chemicals.  Numerous studies have been carried out by medical organizations in India and published in the international peer-reviewed press on the toxicity of endosulphan in rural communities.  I therefore find it utterly perplexing why we should read in the press that Indian doctors have made declarations on the health risk of the GM brinjal. We must really ask the question of who would stand to lose if GM brinjal reached the market in India, and maybe in our search for the answer to this question, we may understand better the motivation behind the campaign to ban GM brinjal. I think it is important that the relevant ministers for health, agriculture, finance, and the environment should consult more to develop a multi stakeholder plan for the role of GM technology in the future of Indian agriculture. Is the public concern about GMOs higher in Europe than in India? I would not say that concern is higher in Europe than in India. It is important to understand that agriculture has a very different relevance for Europe and India. In Europe, only two percent of the workforce is involved in agriculture, whereas in India around 60 percent—the majority of the country’s poor are involved in agriculture, and many of the farmers cannot afford the inputs required for the high productivity practices we see in Europe. It is in this context that we should view this point.  European farmers and consumers have the luxury of choosing to produce or consume organic, conventional or GM produce.  Providing enough food, or incomes for the rural poor through more productive varieties or the sale of cash crops such as cotton is essential for India.  India should be able to make its own decisions about what the most appropriate technologies are needed to meet these goals. We have already seen the rapid adoption of GM cotton in locally bred varieties adapted to the growing conditions in the different parts of the country. It is important that India can make similar decisions for the release of insect (Bt) resistant brinjal and other crops. In the future, it is widely acknowledged that India will see dramatic reductions in yield as a result of climate change.  It is therefore essential that scientists and seed companies – with the correct policy frameworks and investment infrastructure can develop new varieties that are designed to meet this challenge under appropriate biosafety regimes. At the same time, the purchasing power of an increasingly urban population in India hints at a shift in diet habits.  The production of sufficient feed for livestock is an important priority for future scientific and policy objectives, and Indian scientists can and must play an active role in tackling for this challenge. What is needed to reduce the public concern about GMOs in the developed and developing countries? Science-based, balanced and objective debate, at the highest level, followed by unambiguous dissemination of the real risks and benefits to all stakeholders.  In the future we will need to double food production to feed nine billion people. With less available arable land, fewer chemical inputs, less water, and fewer people involved in primary agriculture, we need to look at all options including GM crops to meet this deep rooted and complex challenge. The public need to be engaged in this debate, so that they can understand the complexity of the challenge facing society and the environment, the urgency of the need to find solutions, and the pivotal role innovation in agriculture will bring to implementing change. Can you tell us more about your organization IPBO and its activities? We founded the Institute of Plant Biotechnology for Developing Countries (IPBO) in 2000. It is an initiative supported by the Flemish government and the Suri Sehgal Foundation, (an organisation committed to rural development programs in India). We exist to  strengthen training of plant biotechnologists and plant breeders in developing countries; enable the implementation of science-based biosafety policies in developing countries and act as a focal point and internode to promote and leverage outreach for the biotechnology platform of Europe to developing countries. IPBO today is an internationally recognized center for training on plant biotechnology, biosafety and international regulations that govern the cultivation of genetically modified plants. It represents a powerful forum to both leverage the opportunities plant biotechnology presents for sustainable rural development, and challenge the obstacles facing its deployment. IPBO advocates support for global R&D networks in plant biotechnology to construct local scientific capacity building of relevance to local bottlenecks and challenges. IPBO is lobbying for the harmonization of regulatory norms, political consistency and public awareness of plant biotechnology for development, and its in close interaction with the leading international organisations involved in the deployment of plant biotechnology and GM legislation.  Narayanan Suresh with Jahanara Parveen ]]> <![CDATA[New Age Diagnostics]]> https://biospectrumindia.com/news/95/6450/new-age-diagnostics.html https://biospectrumindia.com/news/95/6450/new-age-diagnostics.html Wed, 04 Feb 2009 12:12:00 +0530 New Age Diagnostics Believing  in the mantra of different strokes for different folks, new age diagnostic companies can perhaps change the face of an industry that reels under slackened growth. Aslight change in the tactics can pave the way for a radical breakthrough, this is applicable to the Indian diagnostic market. Growing at a rate of 15-20 percent, the market had been facing  myriad bottlenecks in its progress route and  was slammed by critics and  market analysts as a highly segmented market that sans regulation and parliamentary pathways. Now that can be passé as the industry is heading for a complete makeover.  Backed by the spirit of entrepreneurship, rising awareness among the Indian populace  about the concept of modern healthcare coupled with India being recognized as a genetically heterogeneous country, the diagnostic market is now witnessing the flourishing of new age diagnostic companies. So what are these new age diagnostic companies and what distinguishes them from the companies who had been dominating the scenario till date? The terminology coined is ‘New Age’ because these companies have taken the plunge to explore new territories and divert their focus from the usual business models pursued by most of the Indian companies till date. So today we have companies looking at core businesses like diagnostic testing of patients at the genetic level in order to prescribe medicines and drugs suited to the patient’s metabolism rate and single-nucleotide polymorphism (SNP),  tests looking at gene mutations,  manufacture of antigens from natural and cell derived sources. The cost-effective quotient of these methodologies are the icing on the cake. Though at an initial stage of growth, these methodologies can fuel the growth for an industry reeling under clogged growth. BioSpectrum, has kept a close watch on market trends across the country and has managed to bring those companies, who have adopted unique business models to explore the untrodden path, to the limelight. Yashraj Biotechnology, Mumbai Yashraj Biotechnology Ltd (YBL) is established in 1999. It is the brainchild of Arvind  K  Bhanushali, the founder director of the company and his brother Paresh B Bhanushali, the director of R&D and production at Yashraj  Biotechnology Ltd. YBL deals with the business of manufacturing and supply of diagnostic antigens, which are native, cell derived and antibodies, mainly monoclonal, to kit manufacturers and distributors. The company had received the FDA (India) license and ISO 90001:2000 certification in 2002 for the manufacture of these antigens and antibodies. Dr Chander P Puri, CEO, YBL, who has in his kitty research projects in molecular diagnostics, hormone-receptor interaction, pharmacokinetics, pharmacodynamics and  toxicology, said, “ We extract these antigens from the human biomedical waste, especially the human saliva. Usually these biomedical fluids are disposed off by hospitals and so is left unused. YBL negotiates with these hospitals to have a storage center for these biomedical waste which is subsequently transported to our laboratories. This ultimately comes under affordable diagnostics. Affordable because the ingredients which  further go into the diagnostic kits are indigenously produced. We were always looking at methods which could be affordable to the people.” “Currently we are manufacturing antigens of native human origin, which can be used either as standards or calibrators in various assay formats or immunogens for raising antibodies or for laboratory-based research and development,” added Dr Puri. The monoclonal antibody products will soon be available for use as reagent in diagnostic kits. At present, the company is focusing on diseases like tuberculosis, malaria and sexually transmitted diseases like HIV/AIDS. YBL is also in the process of coming out with a cell driven antigen for TB diagnosis and one monoclonal antibody is under evaluation. Like for HIV/AIDS, YBL is coming out with an antigen extracted from human saliva. YBL has brought out 13 products into the market and nine products are in the R&D phase. The research team also conducts a viral safety testing for all products to be released. All source materials are tested for HbsAg, the surface antigen of the Hepatitis-B-Virus (HBV), anti-HIV I/II and anti-HCV. Only non-reactive material is used for processing. The non-reactive released are tested for the absence of viral (HBV, HCV and HIV) genetic material by PCR. HBV is not tested in HBsAg.    Yashraj is also in the business of contract manufacturing using the company’s own or customer supplied raw material. In this case, projects of  antigens is taken up either through joint R&D venture or exclusive technology transfer for buy back. To augment its business, YBL has a scientific advisory board with members like Prof. G Padmanabhan, who is  the chairman of the scientific advisory committee of Yashraj Biotechnology Ltd. The board is responsible for brainstorming and hashing out ideas  about product manufacturing and accordingly charts a pathway for extraction of  antigens and antibodies from human biomedical fluids (especially saliva). YBL houses facility centers like the native antigen facility, cell culture facility, quality control, R&D, experimental animal facility.  New business opportunities for YBL are in the areas like supply of cell-derived antigens and antibodies, monoclonal antibodies using hybridoma technology and polyclonal antibodies; cell culture facility for expression of  patented clones (diagnostic and/or therapeutic) and the use of experimental animal facility for drug development. YBL intends to come up with a 1,50,000 sq m facility, either for contract manufacturing or as a joint venture set up. Having achieved milestones and success in the indigenous production of antigens and antibodies, YBL is now looking at diagnostic kits manufacturing space. The company has already identified the technologies, in talks with financiers and there are four buildings already allotted for it. Also they are in talks with scientists from all over the world. Acton Biotech, Pune The tagline of the company, ‘celebrating genetics’, best describes Acton’s business model in a nutshell.  Pune-based, Acton Biotech, was founded on the scientific contention that different people react differently to drugs because of their genetic structure. This idea  is well explained as four people represented in red, blue, yellow and green. The person in red represents 60 percent of the population, who respond positively to a drug; about 25 percent of the population are fast metabolisers of the drug that means the drug will get washed out of their body before it can have any positive effect, this population is represented by the blue person; another 10 percent of the population are slow metabolisers, they are represented by the yellow person, people in this population will have minor or major side effects because of accumulation of the drug, as the drug gets washed out very slowly and finally the green person represents the remaining five percent of the population, which shows undetectable or no enzyme activity and so all the drug taken in by the person keep accumulating and this can cause severe side effects. Throwing light on Acton’s business model Sandeep Saxena, founder and CEO of the company said, “Nowadays, choosing a drug for any complex disease like cancer is  very difficult because of the difference in the rates of efficacy of these drugs amongst the Indian populace, as cancer drugs are inherently toxic to some of them. This difference in efficacy is because of the variation in metabolic rates of enzymes from person to person. Acton focuses on the basic DNA code, checks for the enzymes that are responsible for the metabolism, mutations in the genes and suggests drugs according to the genetic structure of the person. This saves both cost and time.”  Acton, an angel-funded company, has its genesis way back when founder and chairman, Saxena was graduating with an MBA degree from Nirma Labs affiliated with the Nirma University based in Gujarat. “At the end of the course we are supposed to  write a business plan  for our start-up company. If that plan would be accepted then they would give us seed fund to initiate that start-up. Our business plan finally got accepted for incubation,” recollected Sandeep Saxena.    “We did a detailed study and got all the research articles on pharmacogenomics and zeroed in on the important genes and expressions and its functions. At that time we had no focus. We looked into diseases like cancer, central nervous system (CNS) and depression. Then we decided to focus on oncology as it is the most widely read and researched field that boasts a huge market in India,” pointed out  Saxena. While commenting on the modus operandi of the company Sandeep Saxena said, “We have a laboratory in Pune with the basic set of equipments. We collect blood samples from all across the country, we extract the genes while focusing on single points called single nucleotide polymorphism (SNP). From our background research we got a clear idea about the drug response in different patients. Acton’s sales force educates doctors, update them on the different drugs and the type of SNP they will positively react.” Acton now follows one gene-one drug correlation. Take for instance the somatic KRAS gene mutation, which is responsible for therapy resistance to tyrosine kinase inhibitors such as cetuximab, in the metastatic colorectal cancer tissue. Around 40 percent of the population does not show any response to the drug because of mutations in the KRAS gene. Acton offers this KRAS gene mutation testing, which should be done immediately after the diagnosis. According to the National Comprehensive Cancer Network (NCCN), only patients with tumors of the abnormal type of KRAS gene should receive treatment with the epidermal growth factor receptor inhibitor cetuximab. For this type of genetic testing already 30 patient samples have been analyzed by Acton and tests have been repeated. Turnaround time for this test is 10 days and tests are done after optimizing the DNA extraction from formalin fixed paraffin embedded (FFPE) blocks and the polymerase chain reaction (PCR). “From January onwards we ramped up everything right from the number of people, lab equipment and research by recruiting sales managers and executives, we started opening up blood collection centers in Mumbai, Hyderabad, Chennai, Baroda, Ahmedabad and Surat. We also have tie-ups with hospitals in Delhi, Hyderabad, Bangalore and Kolkata,” pointed out Saxena. Acton intends to focus on areas like cardiology and diabetes. “We are talking to cardiologists. This is a recent initiative taken by the company. We believe that genetic tests will avoid severe complications,” concluded Saxena.  Ch Srinivas Rao along with Nayantara Som ]]> <![CDATA[Nanobiotech market forecast]]> https://biospectrumindia.com/news/95/1910/nanobiotech-market-forecast.html https://biospectrumindia.com/news/95/1910/nanobiotech-market-forecast.html Wed, 04 Feb 2009 12:02:00 +0530 Nanobiotech market forecast It would take India some more time to arrive on the nanobiotech map. -Bhuvaneashwar S, senior research analyst, technical insights, healthcare, Frost & Sullivan The nanobiotech market is as nascent in India as it is anywhere else in the world. At present, it's very early to talk about a market figure, specifically for biotechnology, because indigenous products in biotechnology are yet to emerge from the subcontinent. The Indian government has allocated a budget of Rs 1,000 crore per annum for nanotechnology, which is much less than the global funding for nanotechnology. Given that the revolution has just begun in India, it could take as long as a decade before India is able to announce a sizable market in nanotechnology and possibly longer before it talks about the contribution of biotechnology to India's GDP. As of 2006 roughly 40 products were released in the nanomedicine space and most of these so called â€œbiotechnologyâ€? derived products were in fact modifications of gene delivery systems conventionally employed in biotechnology, barring a few products that focused on application of nanoparticles. In essence, the global funding has been around $3 billion for nanotechnology. However projections on a 28 percent growth rate and the industry touching a $1 trillion market in 2010 must be taken with a pinch of salt. While the innovation potential in nanotechnology is much higher in areas outside the life sciences, the life science industry itself needs to face a host of critical issues in the form of social, ethical, regulatory and economic concerns. Hence from the perspective of biotechnology, the operation of the critical mass in determining the total global output would dictate the long term potential of biotechnology to contribute to the magical and optimistic $1 trillion projection. In other words, as far as biotechnology is concerned, the commercialization potential of biotechnology would be inversely proportional to its ability to address and resolve the critical mass of ethical, social and regulatory issues which currently are major limiting factors against biotechnology achieving its full innovation potential. The unfortunate aspect of biotechnology is that it cannot be compared with the pharmaceutical market which is mature and largely a cash cow. With the recession affecting the world and limited liquidity in the market and eagerness to invest is low and biotechnology research from a commercial point of view may not be doing well. Members in the healthcare space have claimed that their industry is recession proof as under grave economic conditions among all costs, the highest costs would be that of healthcare,which would essentially increase the demand for medicines. The focus thus in the current times would be to involve technologies in medical science that would have a quick lead time as opposed to being stocked as work in progress for a long time. Unlike other industries, investors and venture capitalists of biotech sector would need to wait anywhere between three and six years to see returns. Given the grim scenario and the high substitution threats faced by biotechnology, the market for biotechnology products may be lower than expected but may not be bad enough to shut down operations because at the end of the day it addresses serious medical needs which apparently are a driving force for the healthcare industry globally. Legal and policy initiatives needed to fuel nanotech growth in India A comprehensive new law on nanotechnology is not needed but some amendments in the relevant legislations are required. No need for a separate regulatory authority but an expert committee must be constituted comprising members from relevant departments and ministries. The committee should make short term recommendations in light of growing application and commercialization of the technology. Precautionary principle has already been adopted in environmental regulation, and should be extended to nanotechnology regulation, considering the uncertainties. Manufacturers, especially of those products that have a direct contact/ implications for humans, should have limited liability. These products should be identified and listed. Insurance could be a suitable option for covering such liability. Regulatory framework should take into account the phase of Nanotechnology development and the regulatory intervention should be as per the stage of development and knowledge of risks. All evidence based data should be admissible irrespective of the country of study, while designing the regulatory framework for Nanotechnology The Indian patents Act needs to define a clear definition and classification of nano particles and nanotechnology. These are the recommendations presented at a national conference on â€œNanotechnology and Regulatory Issuesâ€? organized by TERI on the first week of January 2009, in Kolkata. The aim of the conference was to map the national and international regulatory developments with reference to EHS aspects (Environmental, Health and Social). This included a discussion on risks emanating from nanotechnology, the nature, scope and design of regulatory instruments, explore the dimensions of the current law and regulatory instruments in place and provide for a gap analysis, analyze the role and value of technology assessment, and explore other cross cutting issues like IPR regimes, institutional role and capacity, and ethical issues. Nano research activities in India Development of micro devices for minimally invasive surgery and surfactant nanoparticles for curing respiratory diseases by the Department of Chemistry, IIT Mumbai. Dabur has launched Nanoxel-a drug delivery system for the anticancer drug Paclitaxel. A typhoid detection kit developed by DRDE Gwalior using a nanosensor developed at the Indian Institute of Science (IISc), Bangalore. The Department of Chemistry, University of Delhi has developed nanoparticles to encapsulate steroidal drugs for delivery to the eye--an invention that has been transferred for commercialization to Panacea Biotec, Chandigarh. Bhaskar Center for Innovation and Scientific Research, Chennai, is developing an antimicrobial spray using silver nanoparticles and herbal extracts. The Central Scientific Instruments Organization is developing a nanotech-based kit for tuberculosis. Center for Nanobioscience Agharkar Research Institute, Pune is working on several interesting problems such as use of super paramagnetic nanoparticles for the treatment of cancer by hyperthermia; Development of nanotechnology based methods for the rapid diagnosis of diseases; Nanomaterials for the delivery of biopesticides; Studies on Ayurvedic bhasma preparations which are known to contain nanoparticles of metals, etc. ]]> <![CDATA[Nanobiotech park]]> https://biospectrumindia.com/news/95/7549/nanobiotech-park.html https://biospectrumindia.com/news/95/7549/nanobiotech-park.html Wed, 04 Feb 2009 11:49:00 +0530 Nanobiotech park Nanobiotech park Nanobiosym Inc, a globally recognized nanotechnology firm is setting up India’s first Nanotech park, The Nanobiosym Technology Park (NTP) in Ahmedabad in a public-private partnership with the state. Dr Anita Goel, chairman and CEO, Nanobiosym shares here views on the nanobioscience initiatives. Do you think there is a lot of hype around nanotech and real applications in the field of medicine are far away? There is certainly a lot of buzz out there about nanotechnology and thus one has the additional burden (of proof) to separate fact from fiction and the real applications from the far-off ones. Nanotechnology overall is still in its early stages as a field and its impact on commercial arenas is far from realized, but in several sectors its seems to be right on the horizon. Medicine and nanomaterials may provide some of the first low hanging commercial fruits from nanotechnology. In medicine, for example, nanotechnology is enabling novel diagnostics as well as new approaches to therapy and drug delivery. In nanomedical diagnostics, I envision the impact of this technology to be somewhat similar to the cell phone industry. We saw a paradigm shift in the telecom industry when computing and communications devices became portable. Likewise, I believe that we will see a similar shift in healthcare when the ability to detect and diagnose disease can be taken out of pathological labs and put in the hands of doctors and nurses, and healthcare workers. Well, at least this is the motivation and vision behind our Gene-RADAR technology platform. What are some of your focus areas at Nanobiosym? Nanobiosym focuses on creating innovations on the interface of physics, medicine, and nanotechnology. One particular interest of mine is nanomotors or molecular machines that read/write information into DNA. We also work on harnessing these nanomachines for various applications ranging from novel nanomedical diagnostics to nanomanufacturing to more far-out applications such as nanoscale energy transduction  and biocomputation.  Nanobiosym has also developed a nanotechnology-enabled diagnostics platform called GeneRADAR.  This platform enables portable detection of infectious disease.  Envision mobile diagnostic devices which can analyze a drop of blood or saliva and quickly identify infectious diseases and pathogens at the point-of-incidence. Our commercial engine Nanobiosym Diagnostics focuses singlemindedly in commercializing this platform and its related products into various world markets. I see a huge unmet need in the rural villages of India, for example, where there’s a problem with basic sanitation and hygiene.  Moreover, there’s no hospital and certainly no pathology lab in these villages. If the villagers are lucky, there might be a social healthcare worker who comes once a month and transports blood samples back to the city for testing and analysis. Imagine having a simple, handheld device that healthcare workers could take with them into the village and use to diagnose problems on the spot. Our Gene-RADAR technology platform has many other commercial applications. We have looked at the life sciences tools market as well as the bio-defense market where we are working closely with the US military and Department of Defense. We envision our portable biosensor chip will ultimately impact biodetection in several different sectors, including water testing, food pathogen testing, animal and livestock testing, blood and organ transplant testing, agro-bio testing etc. Can you tell us more about the nanotech park that you are setting up in Gujarat? Some departments within the Indian government as well as some state governments have expressed enthusiasm for Nanobiosym to establish the Nanobiosym Technology Park in India. We envision the Park as an integrated Knowledge Ecosystem  comprised of an R&D center, incubator, business hub and world-class education center for nanotechnology. The Nanobiosym Technology Park is poised to bring best-of-breed players into a single, integrated ecosystem  focused on bringing the benefits of the most cutting edge, emerging technologies to people in emerging markets. Our vision is to work symbiotically with India. In the US, we will do prototyping and some of the initial innovation. In Nanobiosym Technology Park in India, we plan to do scaled-up manufacturing, some of the clinical testing for the local markets, and other advanced R&D around the GeneRADAR technology platform. That will not only help drive down the cost of production, but also allow us to tailor the technology and its products to local markets, thus making the benefits of our technology more affordable and accessible to the people of India and other emerging markets. Why is most of the nanotech research still done at academic institutions? Nanotechnology is still a nascent field in many ways. Nanotechnology as a science and industry will enable new innovations and collaborations at the global level across many conventional boundaries. It’s highly interdisciplinary, and as a result, academic institutions organized around around the traditional fields of physics, chemistry and biology are not optimally positioned to advance this area.  It is an area, where we see a lot more collaboration between industry and academia. One of the goals of the Nanobiosym Technology Park is to help incubate and commercialize innovations in nanotechnology. What is the current size of the nanotech industry in India and globally? Nanotechnology’s ability to touch a number of industrial sectors has led to a huge growth in the level of discovery, investment and application over the last 10 years.  According to Nature Nanotechnology, if we were to measure the progress in terms of the number of patents, then nanotechnology is most certainly one of the fastest-growing sectors: since 1995, the annual number of patent applications for nanotechnology-related discoveries has grown threefold.  Globally, over $13.5 billion is being invested to explore the potential for nanotechnology to impact fields such as biotechnology, materials, construction, energy, and textiles. India and other hypergrowth economies are uniquely positioned to take a leadership role in moving nanotechnology forward. What are some of the major drivers now? It is very important to have leaders with the vision to forge ahead in this field. I believe in introducing cutting-edge technologies into emerging economies early on. Often a huge unmet need can be addressed by leapfrogging or bypassing the need for conventional  infrastructure. Furthermore, governments around the world are realizing the great potential of this new technology and dedicating budgets to its development. The United States Congress, for example, recently  passed the $1.5 billion National Nanotechnology Initiative which coordinates with over 25 different government agencies and numerous research institutions and universities. Nanobiosym plans to work closely with local governments in maximizing the socio-economic benefits of such emerging technologies for the local people- with a focus on driving hi-tech innovation while also maximizing its impact for the common man. India’s First Nanotech Park Nanobiosym Inc, a globally recognized nanotechnology firm is setting up India’s first Nanotech park, The Nanobiosym Technology Park (NTP) in Ahmedabad in a public-private partnership with the state. The 500 acre nanotech park will  include: a Nanobiosym incubator for research and development, a manufacturing engine, a global health village, a global business center, an institute for education and human resource development, and green living space. The Nanobiosym Technology Park aims to be an innovation epicenter that will bring together top talent from around the globe  for cutting edge research, learning and incubation, and commercialization of new nano-enabled technologies and products. The innovative public-private partnership between Nanobiosym and the State of Gujarat will maximize the benefits of the park for both the state and the country. The park is expected to generate billions in foreign direct investments and international commerce and create thousands of new jobs in  cutting edge industries such as nanotechnology, biotechnology, high tech manufacturing and medical tourism. The park will bring the latest medical developments including the GeneRADAR, to improve the state’s healthcare infrastructure and attract world class talent to stimulate world class development. Nanobiosym is also forming a global consortium comprising of best of breed partners from a variety of sectors like R&D, education, healthcare, infrastructure development, finance and banking, knowledge partners, multinationals and small/medium enterprises. The power is expected to act as a global powerhouse with a focus on hi-tech innovation and entrepreneurship. Jahanara Parveen ]]> <![CDATA[Nanobiotech pioneers]]> https://biospectrumindia.com/news/95/7972/nanobiotech-pioneers.html https://biospectrumindia.com/news/95/7972/nanobiotech-pioneers.html Wed, 04 Feb 2009 11:40:00 +0530 Nanobiotech pioneers Nanobiotech pioneers There are several organizations that have been active in India. BioSpectrum presents the activities of some of them here. NCRM Chennai-based Nichi-In Centre for Regenerative Medicine (NCRM) has been working on close to 240 different nanomaterials and technologies in specialties such as ophthalmology (corneal regeneration), orthopedics (cartilage injury repair), and hematology (expansion of hematopoietic stem cells). Virtus Technoinnovation Mumbai-based Virtus Technoinnovation Pvt Ltd works on the science of gene repair therapy which CEO, Dr Tripathi terms as biomimicry. Its research team at present is working on a technique which will slacken the pace of the aging process in a human being. “Ongoing research is done in the field of biomimicry by topically using nanoparticles of the 92 trace minerals and the 28 amino acids. We call it we are mimicking the ‘gene-repair-experience’ of the fetus floating in the amniotic fluid in the mothers womb. The fluid contains nanoparticles of the same minerals etc. in organic form. The inactive genes of the fetus received from parents at procreation age are being ‘in vivo repaired’ in the mother’s womb,” said Dr Tripathi. Despite this being known to science for past few decades, Dr Tripathi claims, that he is the first scientist to study the receptors under the skin of the fetus carrying the minerals to the gene-proteins. “The contention here is that the human genome which is responsible for the whole process of aging remains active at birth but then by the time we reach the age of 25 years, 90 per cent of them become silent,” said Dr Tripathi. Tata Chemicals Pune-based  Tata Chemicals Ltd (TCL) is also working on nanotech-based products that are still some distance away from commercialization but was reluctant to give out details. “The main research in TCL is around nanotech and biotech based products and processes,” was the only statement that was brought out. Similar is the case with RLS. The company at present does not have any product offering in nanotechnology  but is researching on delivery systems using nanotechnology Nanomedicine, that involves drug particles engineered to the size of an atom, is at the frontline of new drug delivery. It is playing a key role in life cycle management of existing drugs, where novel formulations based on nanomaterials are enhancing bioavailability and efficacy, and reducing side effects. A number of Indian pharma and biotech companies are working on the applications of nanotech in drug delivery. Dabur Research Foundation Dabur Research Foundation last year launched the indigenously developed nanoparticle paclitaxel formulation, Nanoxel. Speaking about this product, Dr Surendra Tyagi of Dabur said, “Our Nanoxel is the only nanomedicine approved and launched outside US.  It demonstrates improved efficacy and significantly lesser toxicity compared to the conventional paclitaxel formulations.”  It has also been launched in Philippines and we are planning to expand the availability of this product for many more countries including US and EU countries, he added. Dabur Research Foundation has a promising pipeline of other oncology products based on similar drug delivery system. Lifecare Innovations Gurgaon-based Lifecare Innovations is yet another company that specializes in controlled release of pharmaceuticals by employing an array of technologies of novel drug delivery systems (NDDS). The company which was started in 2000 has been the first of its kind to combine liposome technology with nanotechnology for liposome mediated delivery of Amphotericin B through its breakthrough product Fungisome. “Fungisome is an undisputed drug of choice for the treatment of dreaded mucor mycosis which is alarmingly on the rise in India due to indiscriminate use of other anti-fungals in spite of well established knowledge that no other anti-fungal drug is effective in patients of mucor mycosis. We took the laboratory scale technology of DBT and we complemented it with nanosomisation to make nanosomes of liposomal Amphotericin B,” said Dr JN Verma, MD, Lifecare Innovations. Taking the technology a bit further, the company then developed a liposomal dithranol for the treatment of psoriasis. Today Lifecare Innovations has platform technologies for oral and parenteral sustained released nanodrugs. “Using that technology we have developed an anti-TB formulation in collaboration with PGI-Chandigarh. Preclinical toxicology work is over and we are starting clinical trials soon,” added Dr Verma. The company is also working on other oral sustained release nano-drugs for variety of treatments with institutions in South Africa, Brazil and Canada. Velbionanotech Bangalore-based Velbionanotech (VBN) developed a bionanochip which functions in targeting and cure for nephrolithiasis in a disease specific and controlled mechanism of nanomedicine release. Bionanochips can be injected into the blood stream, they circulate and reach kidneys. The bionanochip senses the decreased pH in the environment around the stone and identifies the site for functioning. The decreased pH in the vicinity of the stone triggers the release of the nanomedicine from the VBN bionanochip. The released nanomedicine then function on the stones leading to their removal. The nanochip thus functions with a hallmark of mechanism of disease specific targeting and release of nanomedicine in a controlled mechanism. The company has invested around $10 million on nanobiotechnology through private equity funding. Speaking about his company’s research activities Joseph Asantraj, CEO, Velbionanotech said, “We are currently working on nephrolithiasis, diabetes mellitus and atherosclerosis. Our focus for next nanotechnology products will be on neurological disorders.” We have recently started our research for neurological disorder and we are also planning to come out with Nanodevices which is still under paper work, he added. Agharkar Research Institute Pune-based Agharkar Research Institute (an autonomous institute of the Department of Science and Technology, Government of India) is a pioneer in the field of nanobiotechnology. For the past nine years, its focus is on the applications of nanotechnology in medicine, environment and agriculture. The institute has a strategic tie-up with a start-up company, Nano Cutting Edge Technology Pvt Ltd (Nanocet) floated by Khandelwal Laboratories, Mumbai. Agharkar Research Institute has licensed several patents to Nanocet. In addition, Nanocet has been funding research at the institute for the past three years. The institute has also given a nanotechnology incubator facility to Nanocet in its premises provided expertise to the company on the path to commercialization of the technologies. Talking about this research-industry partnership, Dr Kishore M Paknikar, in-charge, Center for Nanobioscience, Agharkar Research Institute, said, “This arrangement has proved very useful. Recently, the Drug Controller General of India (DCGA) has granted permission to Khandelwal Laboratories for the manufacture of ‘Nanocrystalline silver gel’ for the treatment of burns and wound infections. The gel contains silver nanoparticles made by our patented process that work as a potent antimicrobial agent. This is perhaps the first product of its kind being approved in India. The gel will be available in the Indian market shortly.”  Jahanara Parveen with Nayantara Som and Shalini Gupta ]]> <![CDATA[Nanobiotech initiatives intensify]]> https://biospectrumindia.com/news/95/1770/nanobiotech-initiatives-intensify.html https://biospectrumindia.com/news/95/1770/nanobiotech-initiatives-intensify.html Wed, 04 Feb 2009 11:08:00 +0530 Nanobiotech initiatives intensify Though the Indian government has announced some major initiatives to spur new developments and deals in nanotech, technologies from the laboratories are yet to be commercialized. Nanotechnology in India has emerged as an area of significant interest, both in the academia as well as in the industry. In 2007, India launched a program to promote nanoscience and nanotechnology with a budget of $255 million. Several public and private research institutes are working on carbon nanotubes and nanoparticles. Considering the strategic importance of research and development in this novel area, the Department of Science and Technology (DST) has been encouraging tremendous thrust on nanomaterials. The Indo-US joint forum on science and technology has identified this area of research for intense cooperation. Government of India’s Nanomaterials Science and Technology Initiative (NSTI) potentially offers a venue for greater cooperation. As part of this scheme, Government of India has plans to spend Rs 1,000 crore on nanotechnology research and development over the next five years. Dr Anita Goel, chairman and CEO of the US based nanotech company Nanobiosym said, “Nanotechnology’s ability to touch a number of industrial sectors has led to a huge growth in the level of discovery, investment and application over the last 10 years.  Globally, over $13.5 billion is being invested to explore the potential for nanotechnology to impact fields such as biotechnology, materials, construction, energy, and textiles.” Current status India, China, Japan, Singapore, South Korea, and Taiwan are a few countries in Asia which have significant ongoing research projects in nanotechnology. It is one of the main science and technology priority areas for several government in the Asia-Pacific region. Budgets for nanotechnology R&D have been increased substantially and are more strategically allocated. Joseph Asantraj, CEO of the Bangalore based nanobiotech company, Velbionanotech said, “ The total spending for Asia-Pacific countries has exceeded $2 billion during the last two years and this would continue to increase. Japan has been investing in nanoscience since the 1980s and after the US is the heaviest nanotechnology R&D spender worldwide. China, South Korea and Taiwan have increased their budgets substantially since 2001 too.” Australia is currently formulating a national strategy, but it already has a considerable infrastructure and funding in place. Thailand, India and Vietnam have also identified nanotechnology as a priority area and are taking steps to implement the proper framework. As far as market prognosis is concerned, industry experts claim that it is difficult to arrive at any concrete estimates. “Nanomaterials, particularly nanoparticles and nanocomposites, currently dominate the nanotechnology market. The largest end-user markets for nanotechnology are environmental remediation, electronics, energy and biomedical applications,” said KV Subramaniam, President and CEO, Reliance Life Sciences (RLS).  The market at present is at a nascent stage and has not yet kickstarted completely in India though there are some products which have already been commercialized. Dr Murali Sastry, CSO, Tata Chemicals Ltd (TCL) and a stalwart in the field, added, “To the best of my knowledge, there are some products marketed by one company based on nano-encapsulation developed by Delhi University that made it to the market and it is difficult to estimate the market for these products.” Experts are skeptical about the pace at which research work in nanobiotech is moving. Dr Samuel JK Abraham, Department of Surgery,Yamanashi University-Faculty of Medicine and  Director of Chennai-based Nichi-In Centre for Regenerative Medicine (NCRM), said, “I am not sure on how much of the research work really is in the basic research of nanomaterials and whether we have standardized them in taking them to biotech applications.” Globally the scenario is just the opposite. While Subramaniam estimates the global market at $12 billion, Dr Sastry gives a fairly lower figure. “The global market of nanotech products in medical applications (this would be a subset of all nanobiotech applications) is known to be close to $1.7 billion and is projected to reach $3.8 billion in the next five years growing at an annual rate of 24 percent. Applications of nanomaterials/technology in medical applications are mainly in the areas of imaging, devices, diagnostics and drugs.” In the US and Japan, the nanotech applications are undergoing tremendous evolutions in various fields and biotechnology is one among them. “Japanese firms have been working for the past three decades in the areas of proteomics, cell culture and tissue engineering. The drug ‘Doxil’ which is now available for cancer treatment is a real revolution,” added Dr Abraham. Trends Nanobiotechnology is being considered for direct delivery of drugs into the human body. This apart, the research trends can be numerous. Currently, nanomaterials of different chemical compositions in biomedical applications are pushing the growth of this market. “There is a greater understanding of toxicity issues on the use of nanomaterials in medical and food applications which is expected to drive greater acceptance of nano-based products in such applications. It is also expected that more drug-delivery nanosystems will be approved and in the medium term, diagnostic tools (lab-on-a-chip) will be available for commercial use,” added Dr Sastry. Bhuvaneashwar S, senior research analyst, Frost & Sullivan, said, “The factors fueling growth of nanobiotechnology in India are pretty much the same as that elsewhere in the world. Some key trends that have been consistent across the world have been development of novel means of drug delivery on account of properties of nanomaterials, in vivo imaging systems which offer high potential to study cellular metabolism and prosthetic innovations that offer better tensile strength and resistance to the skeletal structure and development of a customized healthcare setting in response to the genome information overload that has brought out significant interest in designing medication according to a person’s genetic makeup” Speaking specifically on regenerative medicine, Dr Abraham mentioned, “The nanomaterials based implants using ceramics for dentistry and orthopedics, tissue engineered cartilages and cornea are hot topics.” “In vitro cell culture and tissue engineering have been in existence for the past several decades without much breakthroughs because we haven’t changed the protocols of cell culture and the same old biological reagents, culture media, were used without much developments. The biological reagents, culture media, etc. are not only expensive but being biological materials, the possibility of contamination and lot-to-lot variation in bioavailability of the active ingredients, which make reproducibility, are two big problems. But the concept of synthetically produced, reproducible, biological component and contamination free nano materials, nanosheets, films, and scaffolds have made significant impacts. In fact PGLA (used in synthetic surgical sutures) and hydroxy appetite (used in dentistry, orthopedics) heralded the birth of such concept of scaffolds and now with nano-level manipulation of synthetically produced materials which could be good scaffolds we are able to gain significant mileage in bringing expected results in cell culture and tissue engineering,”  Dr Abraham added. “There are myriad factors pushing the growth of this market. Drug delivery vehicles for targeted and sustained delivery of drugs to minimize size effects; better and more reliable tools for early and rapid detection of diseases; development of tools for probing cellular processes in real time (more academic at the moment); nanotech based materials for medical implants and perhaps much less appreciated; and nanomaterials/processes in agriculture and food products. The range of applications also underlines the fact that nanotechnology is an enabling technology rather than a stand-alone one,” pointed out Dr Sastry. VC funding Giving the fact that nanobiotech is a high risk venture, venture capitalists are hesitant to invest in this field. The problem is compounded further as their understanding and views on the subject are a bit blurred. “They are vary of nanotech as a whole and until greater clarity on potential side effects of nanomaterials in medical and food applications become clearer, they may be vary of large investments in nanobiotechnology as well,” revealed Dr Sastry. However Indian companies and research institutes have been fortunate to receive monetary investments to augment their respective projects. Dr Abraham of NCRM  mentioned, “Our organization is an Indo-Japanese firm funded mainly by our Japanese collaborators.” Mumbai-based Virtus Technoinnovation Pvt Ltd, is a player in gene repair therapy. According to its CEO, Dr Tripathi Virtus has signed a MoU with an NRI  investor for the use of gene repair therapy as a tailored SPA for rejuvenation of skin, heart, kidney, lever, nails, hair and eyes.  Dr Tripathi has received Rs 2 crore as technology fees and a 55 percent share in the SPA company which is likely to be launched by March 2009 in Mumbai. “Venture capitalists are already approaching us with high valuation for replacing 70,000 SPAs globally with yearly revenue of $250 billion. India’s share currently is $35 million revenue. One can see the ocean of opportunity when the entire $252 billion of business is likely to turn to India for cost effectiveness and now for the differentiated SPA technology,” informed Dr Tripathi. The recession effect Global recession in general is affecting capital inflows to all sectors of economy and nanotechnology is no exception. “ The recession is adversely affecting all the ongoing projects and certainly the new projects. Venture capitalists are averse to investing in riskier areas like nanobiotechnology. The only projects that would still continue are those funded by government organizations,” opined Subramaniam. Speaking on the same issue Dr Abraham said, “We don’t feel the recession because our research has been going on for the past 20 years and we have developed several applications which themselves are taking care of our research funds. We recently transferred our technology to start a center in Malaysia.” Dr Sastry confirmed, “Yes, there is a delay in the inflow of funds but this has not stopped research work. “There is a temptation to cut funding in research in whatever field during economic downturn times but the companies and investors with a vision step up investment in asset-light and knowledge-heavy possibilities such as nanobiotech.” Government stimulation Government of India has given considerable thrust to nanoscience and  nanotechnology in the recent years. The allocation for the research and development on this technology has increased significantly in the last few years. The national mission on nano-science and nano-technology has been formulated. India has established several nanotechnology programs under its five-year nanotechnology initiative. The government recently announced a $255 million program that includes three national institutes for nanoscience. Two centers of excellence in nanotechnology are being set up in Bangalore and in Mumbai. India has also launched a national program focusing on micro and smart systems and a network program on nanoscience overseen by government-owned R&D agencies. India has also formed the Vision Group consisting of about a dozen researchers from academia, industry and research spheres to develop a national nanotechnology policy. The Department of Science and Technology is backing the Nanotech Mission by providing Rs 50 lakh special grant for nanotech start-ups. It has set aside nearly Rs 1, 000 crore as funds for R&D labs and the academia as part of its nanoscience and technology initiative. Last year, a 14-acre nanotechnology research center was opened at JNCASR near Jakkur  in Bangalore. The Government of India  through the DST and DBT is funding a number of projects in the nanobiotech area. Incubators to promote entrepreneurship in nanotech have also been created at select academic institutes and national laboratories. In addition to this, soft loans to entrepreneurs are also being provided. “The Government of India is taking multiple steps to make India a leader in this emerging area of science and technology. Towards this, the government launched a ‘Nano science & Nanotechnology initiative (NSTI)’ program for encouraging research in nanotechnology. Under NSTI, many R&D projects have been supported in the areas of nanofabrication, nanolithography, DNA chips, nanocomposites, molecular electronics, nanosensors, drug delivery, carbon nanotubes and wires etc. They have also established multiple centers of excellence and core groups in nanoscience. Recently, the Indian government announced setting up India’s first premier ‘Nano-institute’, the Institute of Nano Science and Technology, in Bangalore, under the guidance of Jawaharlal Nehru Centre for Advanced Scientific Research,” said Subramaniam. Dr Abraham however gives a different perspective. He shared, “We haven’t received any direct funding from the government. But our collaborating institute, Institute of Pathology, ICMR has received funds for a joint research and a few other proposals are under scrutiny for funding.” Looking ahead Though the Indian government  is making some major investments in nano, apparently in response to its potential to revolutionize diverse industries like biotech, pharmaceuticals, IT, catalysts, and surface coatings. Yet, the absence of a well defined national nanotech policy, inflexible institutional system and  a lack of capital funding may prove to be a stumbling block for long-term progress of nanoscience in the country. The day government introduces attractive feed-in tariffs, incentives to industries coupled with a national policy, nanotechnology can become the next booming industry in India after IT and biotech.  Jahanara Parveen with Nayantara Som and Shalini Gupta ]]> <![CDATA[New entrepreneurs and enterprises]]> https://biospectrumindia.com/news/95/4923/new-entrepreneurs-and-enterprises.html https://biospectrumindia.com/news/95/4923/new-entrepreneurs-and-enterprises.html Wed, 04 Feb 2009 10:15:00 +0530 New entrepreneurs and enterprises With innovative ideas and strong leadership the biotech industry is all set for an inimitable progress. The new start-up companies are springing up while the others continue to expand their existing businesses and making their presence felt. Get the real pulse of the booming biotech in the country... The rate at which new companies are being created in India is astounding. With the venture capitalists looking for new places to invest their money, the number is all set to increase dramatically. The government is also taking all necessary steps to enhance the development of biotechnology in the country and the new biotechnology policy focuses on promoting biotech research and extends support in the form of incentives, concessions and benefits to new players and entrepreneurs. The biotech incubators play a key role in enabling the new entrepreneurs to convert their research ideas into commercially viable technologies without making a big R&D investment. The central government also took initiatives to encourage the growth of the biotech sector in India. The government instituted the YES program and the Small Business Innovation Research Initiative (SBIRI) scheme to facilitate and stimulate the start-up of innovative enterprises in the biotechnology sector. The scheme was started in 2005 with an aim to strengthen existing private industrial units whose product development is based on in-house innovative R&D, encourage other smaller businesses to increase their R&D capabilities and capacity and cultivate the entrepreneurial spirit by creating opportunities for starting new technology-based or knowledge-based businesses by science entrepreneurs. The excitement and enthusiasm of the companies to the scheme can be gauged from the fact that within the first two months of advertising the scheme DBT received 71 full proposals and 17 concept proposals. So far, the biotech industry in the southern region has shown the maximum interest with Karnataka being the topmost state to submit proposal followed by Maharshtra, Andhra Pradesh, Tamil Nadu and Delhi. Since the last four years, BioSpectrum has regularly been profiling the new enterprises and while also keeping the readers updated with the continuous developments of the companies profiled earlier. New Entrepreneurs Acton Biotech (India) Pvt Ltd. It has been a long road for the Sandeep Saxena, CEO and founder of the Pune-based Acton Biologicals who always aspired to be an entrepreneur in the business of life sciences and has his own start-up business. He joined Nirma University for an MBA course, the university later accepted his business proposal for the start-up, Acton Biotech. Acton team is now working on cancer drugs and is educating doctors about the efficacy of different types of drugs on different types of genes. Acton has 10 collection centers all over the country. Unlike any other diagnostic company, which tests blood samples as per the requirements of the doctor or the patient, Acton collects blood samples from all over the country and then extracts the single nucleotide polymorphism (SNP) in the gene and checks the enzymes responsible for the metabolism of drugs for the disorder or disease and prescribes drugs accordingly. â€œIn a case like oncology, If you look at drugs for complex diseases like cancer they work only on 20 percent of the population on an average. The difference in efficacy is because the metabolism rate differs from person to person,â€? opined Saxena. Currently the company is working on genotype efficacies for oncology. Having a foothold in oncology, Saxena now has plans to move the company into other segments like cardiology, diabetes and asthama, to achieve next year's target revenue of Rs one crore. Ara healthcare Pvt Ltd Ara Healthcare under the leadership of Dr Rama Mukherjee is focussed on developing novel biological entities and providing molecular diagnostic services for genetic and infectious diseases. Dr Rama Mukerjee has been the brain behind Dabur Research for quite a few years where she headed the R&D unit. She is now all set to synergize her scientific capabilities coupled with entrepreneurial spirit as she takes on the mantle of heading her own company, Ara Healthcare. Ara Healthcare is based in Gurgaon. Dr Mukerjee has got together a team of six scientists from Dabur and recruitment is on to ensure that Ara is 30-people strong by this year-end. They already have three molecules from Dabur (for cancer) for further development out of which two are NMEs and the third is a biological entity. It currently has facilities and labs for molecular biology, protein chemistry, protein purification, PCR and a preclinical analytical support lab. The company also received funding under the SBIRI scheme by DBT for developing three recombinant proteins and has close to 50 people now working in various capacities. The company is also developing an array of sophisticated and sensitive diagnostic assays for early disease detection and therapy monitoring. Novalead The genesis of Novalead Pharma is yet another example of a research division being hived out. Towards the end of 2007 Pune-based drug discovery software company, VLife Sciences divested its research arm and named it as Novalead Pharma. Supreet Despande, CEO and the brainchild behind Novalead said, â€œWe wanted to be focused only on drug discovery research while VLife Sciences handle the computation technology part of it. We wanted to be specific and hence we separated the research pipeline for VLife Sciences and that of Novalead Pharma.â€? Initial investment of one and a half crore rupees, came from personal funding and savings of founders and Angel investors. The Series- A venture capital investment was raised in April, 2006 through the Kotak Mahindra - Private Equity Group. As of now, there is a big investor interested in investing, whom Despande did not want to name. Revenue churning will only happen after two years when the licensing of Intellectual property will kick start after human validation will be complete. At present the lead compound for Diabetic Foot Ulcer is in process. By 2011, it should be outlicensed, with the deal touching around $400-700 million mark. The Co-Founder and COO, Atul Aslekar again has the main responsibility to lead technology development and sourcing to continuously improve on NovaLead drug discovery process. In the avenue of technology, Novalead has come up with virtual screening technologies like VLifeAmadeus screening platform and VLifeBiblica knowledge compendium (developed along with VLife Sciences). RAS Lifesciences Set up in March 2008, Hyderabad based RAS Lifesciences is determined to deliver the best and cost-effective solutions for healthcare. RAS offers cost-effective solutions for private and public biotech sectors. Dr Shesheer Kumar, MD, RAS Life sciences believes â€œEach client and program is as unique as the products they bring to our facilities, and we strive to provide the customized service they need.â€? With the changing scene in the country, RAS Lifesciences is also involved in planning their priorities, analyze the research capabilities and foresee the need of the service sector in terms of biotech products. The start up is working on molecular diagnostics and engaged in design development and commercialization of cost-effective screening system for various infections, genetic diseases and various cancers. The company is also working as consultants in biotechnology providing personalized solutions for industries, academic biotechnology teams, individual investigators and investors. RAS Lifesciences is currently doing many research projects in the area of molecular diagnostics, which includes identification of novel markers for detection of cancer, cost-effective assays for infectious diseases and development of Real-Time PCR based quantitation assays. In the coming six months, RAS would be starting its cell culture facility, manufacturing and marketing of diagnostic kits and production of industrial enzymes. New Enterprises New Enterprises Actis Biologics Pvt Ltd (ABPL) ABPL, a 2005 start-up has successfully continued its business of developing new molecules using biotechnology and genetics. The company has developed a unique business model of first scouting for innovative processes or technologies for the discovery of new molecules in collaboration with scientists, entrepreneurs or inlicense the targets, then develop the process and spin it off as a different company and then go to market leaders and strike a deal. The company's first product, Angiozyme, which is used for the treatment of colorectal cancer is due to be out in a couple of months in the market. Other two technologies of the company includes, the VFF2, which enhances protein expression and the MSP36 that is aimed at curing breast cancer. As of now, the latest on the cards for ABPL is its Biocity initiative. Actis Biologics in Malaysia (ABM) holds the responsibility of setting up Actis Biocity, a ecosystem for biotech initiatives or companies to thrive in. ABPL intends to raise funds of approximately $25-30 million through private placement of equity with reputed investors. Funds are proposed to be used for land and building, equipment, product development, technology transfer fee payment, working capital margin and other miscellaneous expenditure. The company has filed 65 patents in India. Albany Molecular Research Institute (AMRI), which started its operations in 2007 has recently announced the expansion of multi-purpose pilot plant facilities in Aurangabad, providing non-GMP manufacturing services of up to 1,000 liter scale. In addition to being a stand-alone provider, the new facility will serve as an extension to AMRI's kilo lab capabilities in Hyderabad. â€œWe are pleased to offer another high value alternative to our customers seeking the cost benefit of doing business in Asia, while retaining the quality they expect from a US-based organization. We also look forward to realizing cost savings at our US manufacturing operations. This expansion further demonstrates AMRI's investment and focus on building a worldwide drug discovery and development platform,â€? said Thomas E D'Ambra, chairman, CEO and president, AMRI. As a value-added service to its customers, the company is also investing in R&D in order to expand its contract services and to identify novel early stage drug candidates with the goal to outlicense that to a strategic partner Biogen Idec Biotech India Pvt Ltd. Biogen Idec, the US based biotech company headquartered in Cambridge, Massachusetts has established its wholly-owned Indian subsidiary in October 2007. The Indian subsidiary is headed by Dr Alpna Seth. The company specializes in drugs for neurological disorders, autoimmune disorders and cancer. Biogen Idec already has tie-ups with Roche and Nicholas Piramal for marketing its drugs MabThera and Avonex respectively. The company is working on developing drugs for several serious diseases such as, Non Hodgkin's lymphoma, Chronic Lymphocytic Leukemia, solid tumors, Multiple Sclerosis, Parkinson's disease, Crohn's Disease, Heart Failure, Pulmonary Arterial Hypertension, Hemophilia B, rheumatoid arthritis, neuropathic pain, etc. Biovel Life Sciences Biovel Life Sciences is yet another example of a successful enterprise. The company within three years of its inception, has expanded its research facility and has set up a new production facility in Bangalore with an investment of Rs 50 crore. Biovel is setting up facilities for research work in drug delivery and monoclonal antibodies. â€œOur philosophy is to cooperate, collaborate and co-develop, and with this attitude Biovel has entered into the collaboration with several national and international companies for technology transfers and co-development of products,â€? said Dr Durgaprasad Annavajulla, director- Technical, Biovel Life Sciences. The company has entered into an inlicensing agreement with Dow Pharmaceuticals,USA, and obtained the technology with global marketing rights for producing the human growth hormone (HGH). Biovel is also developing a department which has the major focus on the delivery systems, either by inventing or by using the expired patents. Further, the company will be entering in the areas of peptides and monoclonal antibodies in the coming years. Cryo-Save India Cryo-Save India, the 100 percent Indian subsidiary of Cryo-Save group, has made its foray into the country by launching a full-fledged storage facility in Bangalore and marketing set-ups all across the country. The new facility is a part of their strategic plan for India and is envisioned to further strengthen the company's position in the Indian market. Cryo-Save India caters to parents growing need of providing bio-insurance to their offspring, the company has plans for a phased launch in key centers across the country. Cryo-Save India will be the only company in India with its unique offering of dual-storage system and this will be available for the first time in the country. They are also the only company that does automatic processing to avoid manual intervention and contamination. The company will be offering the collection and storage of adult stem cells derived from cord blood. The services will be available across all metros and other cities. Genzyme Genzyme India was set up on November 21, 2007, as a wholly owned subsidiary of Genyzme US. The company is headquartered in Gurgaon and looks after the operations of the South Asia region. The objective is to bring the products and services of Genzyme to India. Currently the products available in the country are Thymo globulin(rabbit ATG), Thyrogen(recombinant TSH) and Synvisc(Hyaluronic acid), of which the first two are marketed by Genzyme while Synvisc is licensed out to an Indian partner. The company has set up a dedicated sales force for thymoglobulin and thryogen to cover the entire region and also initiated clinical trials in the country. ICON Central Laboratories ICON plc, a 2008 start-up is the global provider of outsourced development services to the pharmaceutical, biotechnology and medical device industries has opened a full service central laboratory in Bangalore. The purpose-built, 15,000 sq ft facility expands its existing network of laboratories located in Farmingdale, New York; Dublin, Ireland and Singapore. The new laboratory is in the process of receiving CAP (College of American Pathologists) and NABL (National Accreditation Board for Laboratory Testing) accreditation. The ICON Central Laboratory India is being headed by Dr Anuradha Rajput who has eight years of experience with Clinigene International. ICON Central Laboratories is dedicated solely to support clinical trials by providing global capabilities and state-of-the-art testing services with over 98 percent of testing required for any clinical trial performed in-house. The new facility of ICON will provide a broad menu of testing services ranging from basic safety testing to biomarkers, on-site sample management service and storage, project management support for both regional and global trials, logistics support to ensure streamlined transport of study supplies and in-bound specimens and global data management support. Lonza Lonza is headquartered in Basel, Switzerland, the contract manufacturing base, has recently set up shop in India in 2007. In Indian operations they are focusing on five major areas â€“sales of the intermediates for the production of Active Pharmaceutical Ingredients (APIs) used in the ARVs (anti-retroviral) formulations for access-to-medicines markets under President's Emergency Plan for AIDS Relief (PEPFAR). Recently Lonza acquired Amaxa, a market leader in gene transfection into primary cells. Shortly Amaxa product offerings will be available to R&D scientists engaged in biologics research in India. Other avenues include sales and business development of disinfectant formulations for hospitals and pharma clean rooms under the Lonzaguard brand, another arena is building the external manufacturing network of Indian companies to outsource production of small molecules to compliment internal capacities of their API plants worldwide. â€œNutrition ingredients is the other major area where we will soon be exploring marketing opportunities in India in 2007, we acquired two businesses from Cambrexâ€“Bioproducts, which we renamed Lonza Bioscience, and the microbial biopharmaceuticals business, which was integrated into the Lonza Biopharmaceuticals business after the acquisition,â€? concluded Dr Harry Rathore, president and country head, Lonza India. Polyclone BioServices We featured the company in 2006 as a new enterprise has today grown to a complete genomics service provider offering lab and computation based discovery, validation and analysis services to biosuppliers, biotech platform companies and drug discovery companies. With sales representatives based in Germany and the US, the company today caters to customers in Europe and North America. Polyclone has built a strong research background and has put in place a network of partners including Karnataka Cancer Therapy and Research Institute, TATAA Biocenter, Goteborg, Sweden and Center for Functional Genomics, State University of New York, Albany. RFCL What began in 2005 as a 100 percent ICICI venture owned company is today a successful and path-breaking company with interests in diagnostics, biomedical Sciences, veterinary healthcare and scientific laboratory solutions. The company stood 17th in the Biospectrum-ABLE biosuppliers annual survey in August with revenues of Rs 34 crore (Rs 90 crore including diagnova sales) RFCL announced its first global acquisition in the space of veterinary healthcare through a share purchase agreement with Marsing & Co Limited A/S for its Germany based subsidiary co. Bremer Pharma GmbH in March 2008. The company has been on a massive acquisition spree since 2007 with the acquisition of Wipro Biomed- a biomedical, health and life sciences company that strengthned its Diagnova(diagnostics) business. Again in January 2008, it acquired Godrej Medical diagnostics and Alved foods and Pharma. While Godrej Medical Diagnostics strengthened its position in infectious diseases portfolio with Malaria and TB point of care testing kits, Alved, the company's first inorganic acquisition complemented Vetnex (RFCL's Animal Healthcare business) in terms of product profile and distribution network. The company launched its first world class manufacturing plant in Sidcul, near Haridwar, spread across 91,000 sq ft built-up area and designed to conform to the WHO GMP and US FDA standards. The facility currently has the capacity to manufacture 10 million tablets, 3 million dosages of liquids and 12 lakh dosages of powder injectables. This plant has been designed to cater to an increase in demand by 25-30 percent without any additional major investments in the facility. The company is also setting up a laboratory chemicals manufacturing facility in Panoli, Gujarat, at an investment of around Rs 60 crore to cater the demand from western India and is slated to come up in 2009 to cater to global requirements. Xcelris Labs With the global CRO market almost touching a $800 million (according to a Mckinsey report), the opportunities that Gujarat-based Claris Life Sciences had foreseen was thumping. The result was the setting up of a new company named Xcelris Labs in 2006, with an investment of Rs 6 crore. The newly set up CRO provides product development, work largely for generics from regulated markets like the US and western Europe. Three projects worth $3 million from European pharma companies were already bagged. The CRO undertakes product development, regulatory support, bio-equivalence studies and clinical trials, contract research and development, and customized solutions. Xcelris has been concentrating in the critical care segment. â€œA small unit of Xcelris was set up within Claris. To avoid conflict of interest around a year back, Xcelris Labs became a separate entity altogether. We did not want any conflict of interest with the parent company so we became an independent entity a year and half back,â€? said Dr Gita Sharma, head, R&D, Xcelris Labs. The CRO back in September 2008 entered into a strategic Alliance agreement with Drug Monitoring and Research Institute (DMRI), Mumbai to provide bio-analytical or bio-equivalence services. Under the agreement, Xcelris Labs will work with DMRI as a partner to provide BA/BE services to its clients. It is is now waiting for the ISO certification. New Products New Products The nano product series The last two years have seen nanotech showing some signs of commercialization. Dabur launched its indigenously developed product Nanoxel in 2007. Biocon in partnership with Abraxis BioScience, Inc. launched Abraxane, the paclitaxel protein-bound particles for injectable suspension (albumin-bound) in India for the treatment of breast cancer. The phase-III clinical trial in the US demonstrated that Abraxane nearly doubled the response rate, prolonged the time of progression, and improved overall survival in the second-line setting versus solvent-based Taxol in the approved indication. In the US pivotal head-to-head trial, the overall response rate of Abraxane was 33 percent as against 19 percent compared to Taxol. While, Abraxane achieved a 25 percent improvement at the time of tumor progression when compared to Taxol. Champix from Pfizer Towards the beginning of the year, Pfizer Limited launched Champix a non-nicotine smoking cessation prescription drug. Champix (varenicline), is developed specifically to act on reducing nicotine craving as well as smoking. Research shows that the odds of quitting smoking on Champix are twice that of buproprion and four times that of placebo. It is the first such product to be approved by the US FDA in the last 10 years. Varenicline has received a priority FDA review because of its significant potential benefit to public health. The cost comes to approximately Rs 9,000 per course.  It has benefited over 5.7 million people since its worldwide launch in mid-2006. Champix has a novel dual mode of action. Unlike other smoking cessation solutions that work only on controlling the withdrawal symptoms, Champix reduces withdrawal symptoms and also the smoker’s sense of satisfaction derived from smoking. It eases the nicotine withdrawal symptoms as well. Recosulin from Shreya Life Sciences Shreya Life Sciences, India, had announced the launch of its recombinant DNA human insulin spray under its brand name of Oral Recosulin with the technology, RapidMist, being developed by the company’s US collaborator Generex Biotechnology. Oral Recosulin provides freedom from limitations of conventional insulin therapy. Generex’s new technology delivers insulin through buccal mucosa directly to the vascular system.  Shreya will also be launching its third generation Hepatitis –B vaccine somewhere in  February or March 2009. The vaccine will be made out of mammalian cells. Boostrix and Infanrix vaccines from GSK In January, 2008, GlaxoSmithKline Pharmaceuticals Ltd (GSK), announced the launch of two new innovative Diphtheria, Tetanus and acellular Pertussis (DTP) vaccines- Boostrix and Infanrix. Unlike traditional vaccines, acellular vaccines provide far more comfort to parents and the children due to substantially reduced pain, fever and swelling. Infanrix is indicated for childhood immunization against Diphtheria, Tetanus and Pertussis for newborns from 6th week of age. When combined with Hib vaccines it reduces the number of pricks and visits to the doctor. Boostrix can be administered to older children above seven years of age, adolescents and adults and will boost the waning immunity against DTP. Solostar from Aventis Aventis Pharma Limited launched a new prefilled disposable insulin pen, Solostar for use with the 24-hour insulin Lantus. This disposable insulin pen is to be used for the treatment of hyperglycemia in people with type 1 or type 2 diabetes and was made available in India in April 2008. Solostar is a new, easy-to-use disposable pen for administration of Lantus. A Solostar test dose range of any disposable insulin pen comes with doses of up to 80 units adjustable in one unit steps. Solostar meets the applicable standards specified by ISO (International Standards Organization) including the standards for dose accuracy. Solostar, an easy-to-use insulin pen brings greater flexibility to patients and an opportunity for earlier initiation of insulin therapy which may contribute to better glycaemic control. Gardasil from MSD Pharmaceuticals In October 2008, MSD Pharmaceuticals (India) has launched Gardasil, India’s first vaccine to help prevent cervical cancer caused by the human papillomavirus (HPV). The vaccine helps to prevent diseases such as cervical cancer; abnormal and precancerous cervical lesions, vaginal lesions, vulvar lesions; and genital warts, caused by HPV. Gardasil is recommended to females aged between 9-26 years. Cervical cancer, or cancer of the uterine cervix is caused by certain high-risk HPV types that can cause the cells in the lining of the cervix to change from normal to precancerous lesions. If these precancerous lesions are not diagnosed early and treated, they may turn cancerous after a few years. The quadrivalent vaccine is given as an intramuscular injection, in three doses  over a period of six months. Bonista from Ranbaxy Ranbaxy Laboratories Limited (Ranbaxy) announced the launch of Bonista-Teriparatide injection (recombinant human parathyroid hormone) for the treatment of osteoporosis,  in collaboration with Virchow Biotech, Hyderabad. Ranbaxy is the first company to launch this bio-generic product in the world. The product has been indigenously researched at Virchow Biotech and developed with aid from the Department of Science and Technology, Government of India. Januvia from MSD Pharmaceuticals MSD Pharmaceuticals launched Januvia, a breakthrough, once-daily, type 2 diabetes tablet, in India.  Januvia is the first in a new class of drugs known as dipeptidyl peptidase-4 (DPP-4) inhibitors which enhance the body’s own ability to lower blood sugar (glucose) when it is elevated.  The mechanism of action of DPP-4 inhibitors is distinct from that of any currently available class of glucose-lowering agents. Januvia represents the first new class of oral medication for diabetics since 1999.  Jahanara Parveen with Nayantara Som and Shalini Gupta ]]> <![CDATA[Saving the BT Brinjal]]> https://biospectrumindia.com/news/95/1565/saving-the-bt-brinjal.html https://biospectrumindia.com/news/95/1565/saving-the-bt-brinjal.html Mon, 12 Jan 2009 16:06:00 +0530 Saving the BT Brinjal After six years of successful cultivation, the national debate on the desirability of using genetically modified (GM) cotton seeds has more or less been settled. India’s farmers have voted overwhelmingly for Bt cotton varieties. Over 85 percent of the annual production of 3.1 million bales (of 170 kg each) comes from GM varieties. And India has become a net exporter of cotton within six years. Cotton is India’s first biotech crop and the nation is the on the verge of moving up the agricultural value chain by adapting GM food crops. However, India’s federal health minister, Dr Anbumani Ramadoss, who was till recently waging a relentless battle against tobacco use, has turned his attention to GM food crops. He has turned his attention to derail the ongoing regulatory process to approve India’s first GM food crop, a Bt brinjal variety. The health minister, though not directly involved in the approval of biotech food product, has vowed to prevent its introduction in the country. Why is this humble crop,  Solanum melongena L, known as brinjal or baingan in India and eggplant/aubergine elsewhere important to the country’s economy? This highly nutritious, low fat, egg shaped product is known as the “poor man’s vegetable”. India accounts for 26 percent of the global production eggplant, just behind China (30 percent). Within the country, brinjal accounts for 8 percent of all vegetables and is grown in about 550,000 hectares by 1.4 million farmers. The brinjal economy is worth about $2 billion (Rs 9,600 crore) by conservative estimates. Area under cultivation has grown by 15 percent in the last 10 years but the production has barely increased by 9 percent. A major factor is the repeated attacks by the insect Leucinoda  orbonalis or fruit and shoot borer (FSB) which increases the input costs and keeps the production down. This was one of the main reasons why different scientific teams picked up brinjal as the candidate to use the GM technology, successfully done in the case of cotton, to minimize the use of unhealthy chemical pesticides. At least half-a-dozen publicly funded research teams are working on this and US seeds giant, Monsanto has helped its Indian partner Mahyco and other research teams with the technology to overcome the FSB in brinjal in recent years. A year ago, the regulator, GEAC, had approved limited field trials of Bt brinjal crop. A final decision on its commercial cultivation will be taken only after evaluating the experimental data. It is too early for anyone to jump into the debate on the desirability of Bt brinjal. The biotech regulatory system has been revamped with experts inducted in large numbers to evaluate various GM crops. We must have the confidence in our scientific experts. We must also be aware of the practices in other countries. China has so far allowed three GM food crops—tomato, maize and green pepper. At least 15 other GM food crops have been approved for commercial cultivation in various other countries. India’s vigilant public opinion and regulators are capable of safeguarding national health standards and the health minister and other opponents should await the reports of the experimental trials. The Supreme Court of India is also hearing a public interest litigation (PIL) against GM products. The research and regulatory approval process in evaluating the suitability of important GM crops in the country should not come to a standstill due to preemptive controversies. A nation poised to become an economic superpower should not close its options on any product or technology prematurely and allow the experts to come to the right conclusion without extraneous pressures being applied by both supporters and opponents of each options. Biotech has moved forward considerably in 2008 and hopefully 2009 too will be even a better year with the arrival of India’s first GM food crop! <sureshn@cybermedia.co.in> ]]> <![CDATA[â€œOmics and other life science applications are on our radarâ€?]]> https://biospectrumindia.com/news/95/2253/omics-and-other-life-science-applications-are-on-our-radar.html https://biospectrumindia.com/news/95/2253/omics-and-other-life-science-applications-are-on-our-radar.html Fri, 09 Jan 2009 18:14:00 +0530 “Omics and other life science applications are on our radar” —Sanjeev Dhar, country head, sales, LSCA division, Agilent Technologies Agilent India is on a growth curve with its strengths in chromatography and mass spectrometry and is committed to serve the growing life sciences market. What were the growth drivers for the company in FY 2008-09? Life sciences has been one of the key growth areas for Agilent India. On the backdrop of the growing awareness and requirements of regulatory standpoint, both pharma and non-pharma segments have been the strong driving forces behind the company’s rapid growth. India, which is considered as a major outsourcing hub for pharma manufacturing, Contract Research and Manufacturing Services (CRAMS) and clinical research has provided several opportunities for the organization. Agilent’s strong global presence and reliability as a top solution provider have encouraged Indian customers to partner with Agilent in their growth path. Industries such as food quality and exports, which are seeing growing regulatory control on their quality and pesticide contents; commercial testing labs, flavors and fragrances and government research labs are the other key areas where Agilent solutions made major inroads. What are the segments that have contributed to the growth? Pharma segment was a large contributor to the total revenue of the Life Sciences and Chemical Analysis (LSCA) business. Agilent Technologies is an established leader in compliance services, and has time and again helped customers to keep track of Food and Drug Administration (FDA) and other regulatory agency expectations and needs. CRO/CMO and generics/formulations are enhanced by foreign investments with generics market in India continuing to benefit from greater demand for low-cost generics in both mature and emerging markets. Non-pharma contributes the next big share, out of which the major contributors were food testing, flavor and fragrances and commercial testing segments. Agilent started focusing its operations in the non-pharma industry segment from 2005 and since then, this segment has shown high exponential growth and holds tremendous potential for future. Areas such as genomics, proteomics and metabolomics though relatively small, contributors have shown high double digit growths. The company’s after-sales market portfolio for both service products and consumables also contributed largely as lab productivity, instrument uptime and analytical instrument qualification (AIQ) regulation have seen growing awareness among customers. What are the revenue grossing products of Agilent? Agilent’s core strength is its chromatography business wherein its industry benchmarked 1200 series HPLC and 7890 GC, are big revenue grossers in both regulated pharma and non-pharma segment. Addressing the trend of “Fast LCs”, Agilent’s Rapid Resolution LC (RRLC) is a big success in the pharma segment, which enables the switching between standard and rapid resolution Liquid chromatography (LC). It provides the customers with flexibility and high level of reliability, reproducibility, speed and accuracy in either mode of operation. Agilent’s mass spectrometry (LCMS, GCMS and ICPMS) products also saw a big jump in revenue with the industry moving from impurity profiling for drug discovery and development to more of a mass based quantification. With the instrumentation needs growing, products such as Lab Informatics wherein Agilent today has a wide portfolio of solutions like enterprise content management, Open LAB and Electronic Lab Notebook, which have also showed a high double digit growth rate. In line with the high growth seen in instrument hardware sales, consumables have also seen a strong growth and hold a big opportunity for Agilent. Last year Agilent introduced its new 1120 Compact LC looking at the vast potential that is available in the mid range market segment wherein the need was for reliable instruments at a lower cost. The product since its launch in November 2007 has received a positive and overwhelming customer feedback from both pharma and non-pharma segments. What are the trends in the LC market in the last few years and how has Agilent addressed those needs? Last two years have seen an immense pressure on the pharma companies to speed up their drug innovation cycle and get the drug as fast as possible to the market. Also with the growing overhead costs in the pharma and the generics industries, they need to strengthen the outputs from the laboratories by means of more sample analysis per day per instrument. This has resulted into many of the pharma players deciding to buy fast LCs. While most Pharma companies bought fast LCs, few others converted their existing hardwares by modifying them to fast LCs. Agilent was fast to react to such customer needs and introduced kits for 1100 series LC. This gave the customers an added advantage of better asset utilization and hence a preference over the other solutions. Gradually Agilent launched its 1200 series Rapid Resolution LC which has been a big success due to the very fact that the product was developed keeping customer’s interest and needs in mind. Another growth area for LC business during the past years is the mid range market segment which has been steadily growing every year. Customers in this segment are very price conscious and wish to buy products that have a controlled maintenance cost. After understanding the customer needs Agilent introduced its 1120 Compact LC last year. Also as the customers in these segments cannot afford to buy multiple LCs every year, they prefer to trade in their old products for the new technology and this is one area where we are very successful. What will be the future of LC and mass spectrometry (MS) market? As mentioned earlier, industry-acceptance to faster LCs will grow in the coming years. The hardware cost would also increase per instrument and hence customers would prefer to buy instruments that deliver fast LC performance and also give them added advantage and flexibility. With growing lab infrastructure, customers show concern about the instrument maintenance cost; hence softwares or services that would help customers achieve this without an outside support would have a better preference. For MS opportunities in India, the big wave has started to build up. Today you see several customers using the advantages an MS has to offer by means of sensitivity as an additional detector to their existing LC, gas chromatography (GC) or capillary electrophoresis (CE) hardware for their regular applications. The clinical research market in India is already on a boom stage and will continue for at least the next five years. LC-QQQ has a great usage and preference in this industry. Vendors are trying to improve the sensitivity levels of their MS hardware which in a way will help the customers to do their jobs better. LCMS and GCMS are gaining preference in the food industry. The other industry segment where MS is seeing a growing opportunity is the “Omics” area. In the future you would see more and more customers moving to adapt high end MS-MS applications. With regulatory bodies now focusing on heavy metals testing in samples, ICP-MS is seeing larger acceptance in both pharma and non-pharma customers. Although the import license process is much tedious and time consuming, the customers are getting the real benefit. What are the new products that will be introduced in the Indian market? Agilent would focus on high end MS instruments and continue to refresh its core product line of LC and GC. Today, even though a late entrant, Agilent is considered as a preferred vendor by many pharma and non-pharma customers for their basic as well as high end MS needs. Last year, Agilent  launched several new high end mass analyzers like 7000A GC-MS/MS, 6460 QQQ and 6530 Q-TOF, which offer the “best in industry” performance and address the needs of customer in several application areas. The products that fulfill the needs of customers in “Omics” and other life science applications are also on our radar.  Shalini Gupta ]]> <![CDATA[Thermo Fisher Scientific exploring greener pastures]]> https://biospectrumindia.com/news/95/3645/thermo-fisher-scientific-exploring-greener-pastures.html https://biospectrumindia.com/news/95/3645/thermo-fisher-scientific-exploring-greener-pastures.html Fri, 09 Jan 2009 17:35:00 +0530 Thermo Fisher Scientific exploring greener pastures Thermo Fisher Scientific is now venturing into a  business strategy to include not just faster but also user-friendly products in addition to an aggressive  acquisition spree. —Koos Van Der Steujit, vice president and general manager, Thermo Fisher Scientific For the past one year ThermoFisher Scientific (TFS) looks at newer turfs to enhance its growth—both globally and within Indian shores. The Massachusetts-based  company clocked a revenue of $10 million this fiscal,  with its Indian subsidiary itself achieving a double digit growth of around 40 percent and clocking fiscal sales of Rs 394.6 crore from its life sciences focused business. It was the number one Biosupplier in the Biospectrum-ABLE survey for fiscal 2007-08. The company has revolutionized its product offering. A simple case in point being that 15 years ago the best mass spectrometry would take one year to analyze a protein and today this has been reduced to a mere 30 seconds! TFS is also now looking at spreading its capabilities to newer geographies like India and China. Though a country like India accounts for just one percent of its total revenue pie, the region can certainly not be ignored. Projecting stupendous growth, its business in China today is thrice that of India. Its overall growth can be attributed to the spree of acquisitions and collaborations within a span of a year, opening up of new manufacturing facilities and inking major deals and programs with government institutions. —Amit Chopra, managing director, Laboratory products, Thermo Fisher Scientific Acquisitions and collaborations—the global stratagem The year 2008 was marked by acquisitions and collaborations for TFS. The underlying point behind the stratagem is not just doubling revenue but to broaden its geographical distribution and simultaneously widening its product portfolio offering. This business strategy has worked in favor of the company. TFS completed two acquisitions in India. While Qualigens Fine Chemicals, supplier of laboratory chemicals, was acquired from GlaxoSmithKline (GSK) in 2007, and Chemito, a supplier of analytical instruments for life sciences and environmental monitoring applications, was acquired in 2008. And this in a way pushed the company’s annual revenues to double (Rs 395.6 crore) as compared to the previous fiscal figure (Rs 246 crore). “Thermo was also looking for a good equipped team. This acquisition will be of great help for our chemicals, diagnostics and glass ware business,” said Dr G Ramakrishnan, managing director of Thermo Electron LLS, India Ltd.  In addition, Chemito manufactures its own analytical instruments, including gas chromatography, atomic absorption and UV-Vis spectroscopy. Chemito’s analytical technologies and environment instrumentation divisions have annual revenues of approximately $10 million and will be integrated into Thermo Fisher’s analytical technologies Segment. Dr G Ramakrishnan also added that “Chemito gives us a manufacturing base in Nasik and strengthens our analytical instrument base in India. Chemito has developed a good training center and Thermo will be able to strengthen its training base and give hands on training to its customers.” On the global platform, the company has moved at a breathtaking speed and within a span of one month, the company has completed one acquisition and one collaboration. With these acquisitions, TFS got a foothold in anatomical pathology with the London-based, Raymond A Lamb. Clocking annual revenue of $9 million, Raymond A Lamb will be integrated with the analytical technologies segment. TFS had then collaborated with biotech giant Genentech for the development of novel small interfacing therapeutics for Genentech. Speaking exclusively to Biospectrum, Global CEO and President of TFS, Marijn Dekkers said, “RNA interference (RNAi), which is used for silencing bad genes,  is one of the technologies  that I am excited about. We are accelerating all our technology platforms towards this end.” In December 2008, Thermo Fisher also entered into a program, to assist food testing and government labs for the analysis of melamine in food products from China (especially in milk products) in the wake of an alert from the United States Food and Drug Administration (USFDA) on adulterated milk products. TFS will provide the complete testing solution right from sample preparation, instrumentation and consumable along with food experts in the technology. India-China, hotbeds for growth There has also been a paradigm shift in  geographical preferences. The global economy in the coming years will see the dominance of the yellow and the brown men. Recognizing the mammoth business opportunities these regions offer in the future, TFS has already started its ground work. While commenting on this Koos Van Der Steujit, vice president and general manager, TFS, India, said, “A lot of growth will be seen in India and China in the next few years. We aim to double our growth in these regions. TFS is already exploring opportunities in these nations and we will see a lot of actions here.” TFS has taken significant steps over the past few years to expand its footprint in India, beginning with the opening of a state-of-the-art demonstration laboratory in Mumbai that offers customers with its range of laboratory solutions. The company has also added sales and manufacturing facilities to support growing markets, including biopharma services and biospecimen storage, life sciences research and environmental analysis. Thermo Fisher India now has more than 600 employees and 20 facilities, including the new full-service clinical packaging and distribution facility in Ahmedabad. Clinical trials pursuit in India Despite grabbing a  minor share of the pie, India continues to be the center of attraction for the company. With India becoming the hub for R&D, the CROs and MNCs are flourishing in the country, TFS does not want to miss this opportunity. Its clinical trials business has been operative globally. However, it is only recently that the endeavor has been introduced in the Asia-Pacific countries. “These countries have a great potential that is why TFS is looking at setting up its clinical trials business here,” said Koos Van Der Steujit. Recently TFS  announced the official opening of its new $17 million  facility in Ahmedabad to support the growing demand for biopharma services. The 150,000 square feet facility will focus on packaging, global distribution and logistics management of tightly regulated pharmaceutical samples to patients participating in clinical trials across the globe. It complements the company’s existing clinical services operations in the US, Europe and Asia.  “India continues to be a major market of focus for us as we expand our capabilities to support clinical research and development. Our customers are eager to outsource their clinical trials management to partners who know how to work within changing regional and global clinical trial regulations. Now, with the added capacity available with us, we will be able to bring a higher level of technology, quality and expertise to facilitate clinical trials that serve the needs of both multi-national and local pharmaceutical companies,” said Marijn Dekkers Stem cell research ThermoFisher Scientific is concentrating on  providing technology to high growth potential segments that include protein research and stem cell research.  After the Thermo-Fisher merger, in the beginning of January 2008, TFS launched its stem cell excellence program, which will cater to the entire spectrum of stem cell research. “Thermo Fisher Scientific has a continuous focus on providing integrated work flow solutions to some of the most promising areas in scientific research, such as stem cell research, IVF and cell culture,” said Amit Chopra, managing director, Laboratory products, Thermo Fisher Scientific. The line of instruments cater to the needs like collection and preparation, differentiation, characterization, storage and transportation. The expanded stem cell excellence portfolio now includes Thermo Scientific HyClone Advance STEM reagents, kits and stem cell lines, as well as the Thermo Scientific Dharmacon Accell siRNA reagent for gene silencing and Nunc cell culture inserts for cell-based assays. A breakthrough gene-silencing tool, the Dharmacon Accell small-interfering RNA (siRNA) product line, has also been used within the Thermo Scientific Stem Cell Excellence program. The Accell siRNA enables uptake by stem cells and other difficult cell types without the use of viral or lipid-based delivery systems, which can be toxic to cells.  There is no looking back for the company now. Despite the recession and the credit crunch, TFS is optimistic that it will continue on its growth path but at the same time on a cautious note. “We will be cautious  but at the same time invest in high growth areas,” confirmed Koos Van Der Steujit. N Suresh and Nayantara Som in Mumbai ]]> <![CDATA[GM safety assessment guidelines in India]]> https://biospectrumindia.com/news/95/1801/gm-safety-assessment-guidelines-in-india.html https://biospectrumindia.com/news/95/1801/gm-safety-assessment-guidelines-in-india.html Fri, 09 Jan 2009 13:44:00 +0530 GM safety assessment guidelines in India Biosafety regulations have been put in place by various countries including India. The development of a GM crop involves a complex process starting from gene identification, selection, product commercialization and  safety assessment has to be undertaken at all stages of its development. It begins at early gene selection phase by taking into account each gene’s source, previous consumer exposure to the source, and whether there is a history of safe use for source material, the gene and its specific products. After genetic modification, specific GM crop line is selected through a variety of steps in the greenhouse and field during which the biological and agronomic equivalence of the GM crop is compared with its traditional counterpart. Biosafety regulations have been put in place by various countries including India. The regulation of GMOs in India is governed by the “Rules for manufacture, use, import, export, and storage of hazardous microorganisms/genetically engineered organisms or cells 1989” under the environment protection Act, 1986. The two agencies primarily responsible for implementation of the 1989 rules are the Ministry of Environment and Forests (MoEF) and the Department of Biotechnology (DBT) of the Ministry of Science and Technology. The 1989 rules define competent authorities and the composition of such authorities for handling of various aspects of the rules. Six competent authorities are listed in the rules: The recombinant DNA advisory committee(RDAC) The review committee on Genetic Manipulation(RCGM) The Genetic Engineering approval Committee(GEAC) State Biosafety Coordination Committees (SBCs) District Level Committees (DLCs) The Ministry of Health and Family welfare is responsible for ensuring the quality and safety of food marketed in the country and the Prevention of food Adulteration Act enacted in 1954. The Indian Council of Medical Research acts as an advisory body on GM foods and the Ministry of Food Processing industries is involved in developing new regulations for R&D of food processing industries. In addition to MoEF and DBT, the Ministry of Agriculture is responsible for Seeds policy. Before commercialization, GM crops undergo a detailed and specific safety assessment process. This process focuses on the safety of products associated with the introduced gene and any other likely toxicological or anti-nutritional factors associated with the source of the novel gene and the product to which it was introduced.  DBT had formulated Recombinant DNA safety guidelines in 1990 which were further revised in 1994 that covered areas of research involving GMOs. In 1998, DBT brought out separate guidelines for carrying out research in transgenic plants called the “Revised guidelines for research in transgenic plants”. These also include guidelines for toxicity and allerginicity evaluation of transgenic seeds, plants and plant parts. These guidelines cover development of transgenic plants and their molecular and field evaluation along with import and shipment of GM plants for research. The guidelines include complete design of a contained greenhouse suitable for conducting research with transgenic plants and provide the basis for generating food safety information on transgenic plants and plant parts. Acute and sub acute chronic toxicity tests have been included in the DBT guidelines. Many of these test protocols have been adopted from the OECD (Organization for Economic Cooperation and Development) guidelines and modified as per requirements. Separate protocols have been provided for transgenic seeds and vegetables. Similarly protocols have been proposed by designing appropriate experiments to gather data on allerginicity testing in the laboratory. Review Committee on genetic manipulation (RCGM) decides on the actual tests and protocols on a case by case basis. RCGM(Review Committee on genetic manipulation) is a statutory body notified under the Rules, 1989 of environmental Protection Act, 1986 to ensure that the R&D activities undertaken by DBT are carried out in a safe and sound manner. It comprises of 29 experts from various multi-disciplinary fields. The development of GM crops (including imports for research) at the laboratory stage, contained multi-location trials and protocols for the biosafety studies require prior approval of the RCGM. Based on the results of the contained field trials and the biosafety assessment studies, RCGM then makes its recommendation to the GEAC. An approval of GEAC is required to conduct of large-scale field trials to assess biosafety, efficacy of the variety and the agronomic benefits of transgenic seeds. The results of the contained field trials and large scale field trials are then evaluated by the state Agricultural Monitoring Committee (MEC) before recommendations on the efficacy of the transgenic are made to the GEAC. The GM crops for large scale trials are also evaluated under the Indian Council of Agriculture and Research (ICAR) testing system. In addition all institutions involved in any work related to development or use of transgenic(including export/import) are required to set up an Institutional biosafety committee which has an expert nominated by DBT. The GEAC takes into consideration the findings of the biosafety studies and the agronomic evaluation by MEC and ICAR before according approval for the environmental release of the crop. GEAC is the apex statutory body notified under the rules, 1989 of environmental Protection Act to evaluate environmental risk versus societal benefits before release of Living Modified Organisms (LMOs). Any company involved in the development of GM crop has to undertake extensive biosafety assessment which includes environmental safety assessment as well as food and feed safety. Food safety studies are conducted in public institutions such as National Dairy Research Institute, Karnal, and Indian Toxicological Research Institute, Lucknow and are further scrutinized by experts at the GEAC and independent experts as well. Cartagena Protocol on Biosafety The Cartagena Protocol on Biosafety is an international agreement on biosafety, as a supplement to the Convention on Biological Diversity that seeks to protect biological diversity from the potential risks posed by living modified organisms. The Biosafety Protocol makes clear that products from new technologies must be based on the precautionary principle and allow developing nations to balance public health against economic benefits. It will for example let countries ban imports of a living modified organism if they feel there is not enough scientific evidence the product is safe and requires exporters to label shipments containing genetically altered commodities such as corn or cotton. In accordance with the precautionary approach, contained in Principle 15 of the Rio Declaration on Environment and Development, the objective of the Protocol is to contribute to ensuring an adequate level of protection in the field of the safe transfer, handling and use of “living modified organisms resulting from modern biotechnology” that may have adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health, and specifically focusing on trans-boundary movements. The number of ratifications and accessions to the Protocol grew from 143 countries to 151 (as of 15 November 2008). The countries that became Parties to the Protocol in 2008 include Guinea, Guyana, Myanmar, Suriname, Turkmenistan, Kazakhstan, Burundi and Georgia. During the year, the number of countries that finalized their first draft national biosafety frameworks funded by UNEP-GEF reached 104. September 11, 2008 marked the fifth anniversary of the entry into force of the Protocol. ]]> <![CDATA[Union Health Minister on genetically engineered crops]]> https://biospectrumindia.com/news/95/1135/union-health-minister-on-genetically-engineered-crops.html https://biospectrumindia.com/news/95/1135/union-health-minister-on-genetically-engineered-crops.html Fri, 09 Jan 2009 13:25:00 +0530 Union Health Minister on genetically engineered crops The Indian media have widely publicized the opposition of the Union Minster for Health (HM) Anbumani Ramdoss to the genetically engineered (GE) crops, more particularly to Bt brinjal. Professor C Kameswara Rao of Foundation for Biotechnology Awareness and Education, Bangalore, gives us a wide perspective on this. The HM’s stand is basically rooted in factoids and political expediency and not on facts.  His statement that ‘When there are so many indigenous varieties of brinjal in each region of India, where is there a need to borrow this Bt Brinjal from other countries?’ reflects his ignorance of the matter.  All the varieties and hybrids of brinjal used in the development of Bt transgenics are the products of Indian private and public sector.  The Bt gene Cry1Ac has been in extensive use in cotton, which is in commercial cultivation since 2002, as well as in several other transgenic crops in development in India, both in the public and private sectors.  Bt brinjal is being developed in a public-private sector partnership and the Indian Agricultural Research Institute itself is involved in the development of Bt brinjal and several other transgenic crops.  It was the international scientific community, not the anti-tech activists, who have identified the possible biosecurity risks posed by the transgenic crops and devised testing protocols.  The HM and his supporters or the anti-tech activists have no locus standi to trash the combined global scientific wisdom. In India, the matter of biosecurity of GE crops comes under the responsibility of the Ministry of Science and Technology and the Ministry of Environment and Forests.  The Indian Council of Agricultural Research and HM’s own Indian Council of Medical Research are actively involved in biosecurity evaluation of  GE foods and food crops. The process of biosecurity regulation in the country has been reviewed and the National Biosecurity Authority Bill currently on the anvil will take care of any deficiencies and stakeholder concerns, when it comes into force.  If the HM has any specific issues he should take them up with the concerned ministries and not transgress and issue public statements contrary to the stated policy of the central government. The Indian farmers have shown their preference to Bt cotton whose acreage has increased from 0.5 mill. ha in 2002 to 6.2 mill. ha in 2007.  Farmers seek reduced farm inputs and higher returns and would grow even unapproved varieties if they think that they would benefit from them.  Cultivation of illegal Bt cotton (mostly in Gujarat and some other states like Maharashtra and Andhra Pradesh), of some unapproved varieties of Bollgard I and II (Andhra Pradesh) and of Bt cotton even when not approved for the whole state (Orissa), are good pointers to farmers’ attitude.  Banning genetically engineered crops as proposed by the HM and his supporters will lead to chaos as farmers would anyway go for them even when not approved for their region or the state, and all control on biosecurity would be lost. The farmers’ wing of Pattali Makkal Katchi (PMK) is reported to have mustered the support of a number of ignorant and gullible groups to pursue their politically motivated opposition to GE crops.  The HM is playing to his constituency with an eye on the ensuring general elections, ignoring the fact that the whole opposition to GE crops is orchestrated for unscientific reasons, ignoring India’s agricultural needs.  The HM’s promise to the protesters ‘to oppose the move till proper research is conducted on whether it (Bt brinjal) is safe for Indians’ does not hold as a cautious or remedial approach since the damage is more severe from his other statement that the ‘PMK has always opposed GM seeds. As a minister of PMK and as the Union Health Minister, I will continue to oppose it’.  This violates healthy norms of coalition culture.  What we have at the center is the UPA government and not the PMK government and the Union Cabinet is collectively responsible.  His assertion that Bt Brinjal is being brought into the country without proper research on its safety reflects his ignorance of the voluminous biosecurity data already on the official website since September 2008 and/or a calculated indifference to the country’s efforts in ensuring biosecurity of GE products. It was reported that on December 4, 2008, a group of doctors from different streams of medicinal systems have submitted a memorandum to the HM stating that ‘that Genetic Engineering in our food and farming is inherently risky and irreversible and that decision-making in India is currently happening based on the crop developer’s data without any independent research for assessing long term effects’. These doctors, who are compulsive users of manufacturers recommendations and promotional literature to prescribe medicines, are only voicing tutored concerns.  They cannot claim to be more knowledgeable than plant biotechnologists and seem to be as ignorant of the procedures adopted for biosecurity evaluation in the country, which is among the most stringent in the world.  Over 350 million North Americans have been eating GE foods for over 12 years without any reported risks to their health and wellbeing, which is in a sense the largest human food safety trial experiment ever.  The Indian media, which believe that only issues with a negative connotation are newsworthy, gobble up all sundry nonsense and blow it out of proportion, without ever bothering to verify its veracity.  The PMK group is reported to have collected some 70,000 signatures against Bt brinjal. Is this based on an informed decision taken by the signatories?  Even so what is the proportion of this group compared to the country’s population?  Any one is free to choose or reject GE crops but does not have a right to impose their will on the others. On the other side, Sharad Pawar, the union minister for agriculture said on December 9, 2008, that biotechnology could play a key role in the improvement of potato. He rightly said that the rules for regulation of GE crops in India are well in place. On earlier occasions he was optimistic that the Bt brinjal will soon come to the market.  So far as the issues of biosafety are concerned, it does not make a difference whether it is potato or brinjal and the agriculture minister’s stand is clear.    The Government of India is doing a considerable lot to ensure biosecurity of GE crops and to see that the farmers and consumers derive the benefits from the new technology like the people of several other countries.  The HM’s statements run contrary to the union ministry’s policy and it is for the Prime Minister to control the damage caused by discordant notes emanating from his cabinet and to get rid of the jetsam.  More than blaming the HM or even the vested interest groups for unscrupulously exploiting the ignorance or indifference of the general public. I consider the agribiotech industry and the Indian scientific community, who failed to rise to the occasion, as responsible for the turbulence.  As they failed to enhance public awareness on the biosecurity and the benefits of GE crops.  The industry has hardly supported others who work to promote public awareness.  Strong public awareness programs are an urgent need to ensure that the interest groups cannot so easily mislead the media and the public. ]]> <![CDATA[â€œNeedless Confusionâ€?]]> https://biospectrumindia.com/news/95/2296/needless-confusion.html https://biospectrumindia.com/news/95/2296/needless-confusion.html Fri, 09 Jan 2009 12:43:00 +0530 “Needless Confusion” The anti-GM crops statement by the Union Health Minister, Dr Anbumani Ramadoss has already created ripples in biotech sector. Dr KK Narayanan, CEO, Metahelix, President ABLE, Bangalore, registers his opinion on the outcome of Dr Ramadoss’s statement. One sector in our country that is least likely to be affected by the global economic meltdown is agriculture. In the last 15 years, this sector was almost stagnating when other sectors like ser vices and manufacturing were clocking almost double digit growth. The latest economic survey has indicated that the annual growth in food grain production in the country between 1990 and 2007 was a mere 1.2 percent, while the annual growth in population was 1.9 percent, during the same period. We all know that a major food crisis in the country was averted only because of the import of wheat and other grains in the recent past. Thankfully, the growth in non-agricultural sectors had put enough money in the government’s coffers to pay for these purchases. However, this situation cannot continue for long, especially when depressed global demand has been putting a severe pressure on the services and manufacturing-led economic growth of our country. Even before the impact of financial crisis was felt here, there was a growing realization that there is a need to spur agricultural growth in order to achieve all-round economic development and welfare of our people. To achieve this end, Indian agriculture has to break out of the shackles of old and outdated technology. In recent years there have been some signs of this happening. The adoption of the genetically modified (GM) Bt-cotton for large-scale cultivation in the country in 2002, after extensive testing, is a pointer to this fact. Since then the country has seen almost a revolution in cotton production; this was probably the only crop whose production bucked the general trend and grew at over 20 percent year after year. The total cotton production in India in 2002 was 1.4 million bales (of 170 kg) which in 2007 had grown to 3.1 million bales. The area under this crop had remained almost unchanged at about 8.5 million hectares; it was the increase in productivity, from a dismal 275 kg per hectares to over 500 kg per hectares, which was responsible for this spurt in production. From being a net importer of cotton till 2003, India is today a net exporter of cotton. And now, we can claim to be ahead of even the United States in cotton production! While all this has happened, the people who have benefited the most have been the Indian cotton farmers as testified by the very high adoption rates for this technology. Today, over 90 percent of the area under hybrid cotton, which accounts to over 70 percent of the total cotton area and over 85 percent of the total cotton production, is dominated by Bt-cotton, which shows the dramatic success of Bt-cotton. It is therefore quite baffling when the Union Health Minister, Anbumani Ramdoss publicly states that he is opposed to GM crops. Such an expressed view, especially taken by a minister who is a qualified medical doctor, cannot be dismissed as one, borne out of ignorance. Surely, the minister must be pandering to some interested groups or it could be a calculated move to make some political capital, with the next general elections coming in a few months. If the objective is the latter, such a stand is unlikely to yield any political dividends. Farmers form the largest voting sections, if grouped by one’s profession, in our country, and no political party can afford to ignore their interests. The last few state elections, particularly in those states that have significant areas under cotton like Punjab, Gujarat and Madhya Pradesh, have seen political parties and their leaders vying with each other in claiming credit for promoting Bt-cotton. In Punjab, the competing parties even paid for newspaper space to assert this claim. Having savored the benefits of technological products like Bt-cotton in the last few years, it is difficult to understand how the farmers of this country could be persuaded to vote for someone or a party, which opposes the introduction of such technologies. Unless, interest in one’s own welfare gets subsumed by other considerations such as caste, religion and community. The political base of the health minister and his party is limited to Tamil Nadu, where there is increasing cultivation of Bt-cotton. It is notable that the specific districts where the minister’s party has significant following are important areas of Bt-cotton seed production, with thousands of farmers engaged in this activity. The minister is no political novice and in all likelihood, all these considerations would have been factored in, before the public posturing. There is however, no certainty in foretelling how this stand would impact the electoral fortunes of the minister and his party in the coming elections. The political fall-out of an “anti-GM crops” stand could be uncertain, but what is almost certain is the adverse impact it will have on the development and promotion of such technologies, which promise to bring enormous benefits to Indian farmers and to the sector as a whole. While the Government of India has been promoting the development and responsible use of GM technologies in agriculture through policy initiatives and large public investments, such statements, that too by the head of an important ministry, induces a sense of ambivalence. In earlier occasions when statements like this, which have gone against the government’s stated position, have been made by individual functionaries of the same government, other responsible persons have been quick in their rebuttal, in some instances by outright condemnation, but in most instances by conveniently terming them as “individual opinions” and thereby disowning these views as that of the government’s. However, in this case this has not yet happened. These circumstances are bound to make the institutions, especially in the private sector, wary of making further investments in developing and commercializing new GM technologies and this could have long-term implications for Indian agriculture. Though one would have expected the regulatory system for GM crops to have been streamlined, with less  uncertainty and time-bound approval process, particularly in wake of the Bt-cotton experience, the exact opposite is what has happened. Under the ruse of reacting to some of the recent court rulings and the turf wars between the various ministries, the regulatory process, particularly for GM crops has become more tortuous and uncertain. Modifications or additions are being proposed by overzealous officials in the regulatory package, more driven by sentiments rather than any consideration for scientific logic or relevance. While this is the state of affairs, it must be said on all fairness, that there are serious efforts underway to bring in some order to the system based on science and practical need. But these efforts are taking time, more so with the divergent views and interests of the various stakeholders within and outside the regulatory regime. The statement by the minister and the confusion it has already generated, would only add to the predicament of those engaged in reforming the regulatory system. Uncertainty and needless delays will continue in approving new technologies that could put Indian agriculture on a fast-track of growth. There are several such technologies that are sitting on the shelves without reaching our farmers because of regulatory delays. Highlights The Union Health Minister, Anbumani Ramdoss’s public statement opposing GM crops, cannot be dismissed as one, borne out of ignorance. The minister must be pandering to some interested groups or it could be a calculated move to make some political capital, with the next general elections coming in a few months. The statement by the minister and the confusion it has already generated, would only add to the predicament of those engaged in reforming the regulatory system. Uncertainty and needless delays will continue in approving new technologies that could put Indian agriculture on a fast-track of growth. ]]> <![CDATA[â€œNo scientific evidenceâ€?]]> https://biospectrumindia.com/news/95/3455/no-scientific-evidence.html https://biospectrumindia.com/news/95/3455/no-scientific-evidence.html Fri, 09 Jan 2009 12:42:00 +0530 “No scientific evidence” —MK Sharma,  MD, Mahyco Monsanto In the early 1990s, Mahyco was growing cotton but the management felt that the country faced huge loses because of the attack of insects and wanted  to develop a new solution to be resistant to such attacks, a technology which can overcome such a predicament. That is when Monsanto came into the picture and it licensed its technology to Mahyco and a joint venture was formed in 1994. Monsanto gave Mahyco the gene, but it was the latter which initiated the transformation of that gene. MK Sharma, MD, Mahyco Monsanto, shared his views on the debate on GM Foods. Dr Ramadoss has expressed his apprehension on GM Foods. Is he justified? Dr Ramadoss cannot say such a thing because  Bt Brinjal has been thoroughly tested  as per the guidelines. They are found to be harmless. The farmer will have to spray less pesticides because normally excess pesticides in a way enters the food chain. That is when it can be a health hazard. The environmental damages are also less in the case of a Bt crop and above all farmers also gets additional revenue. In urban areas we heartily welcome any new form of technology like computers. Why should we then hinder and put obstacles when a technology is made available to farmers? I can confidently say that the Indian Regulatory system is the best in the world and it is very stringent. It will release a product only when a product is thoroughly tested . When people just oppose for the sake of opposing no matter how much of logic or rational reasons you put forward in front of them they will never be convinced because they have their share of prejudices and preconceived notions. Why India needs GM foods? India needs GM Food crops more than any other country. Brinjal is a tropical plant and grows  well in warm areas like India and Bangladesh. It is a poor man’s crop and farmers are dependent on it not just for revenue purposes but for daily social requirements.  If you go to a field, even if he is growing cereals, he will grow  a few brinjal crops. To kill one insect, a farmer sprays anywhere between 20-50 sprays of pesticides in a crop of 120 days. As a result, there is a damage of 40-60 percent. These sprays are also a health hazard to the farmers who do not even wear a mask while spraying. Farmers had readily accepted this technology in the case of Bt cotton and am sure that the same will be replicated for Bt brinjal. 80 percent of farmers use transgenic seeds today. Why are some countries opposing it? These countries have less area for agriculture. Agriculture is not their main source for economic growth and moreover it is not a need because their production of non Bt crops is so high.  In places like Africa it is more of ignorance and apprehension towards new technology. India in contrast is ahead of such countries. China is in the process of releasing Bt rice. It had mastered the hybrid seeds for rice and the Chinese Government is proactive. Bt Brinjal The following environmental biosafety studies and food/feed safety studies which are prescribed by the Government of India regulatory bodies have been completed on Bt brinjal: Pollen flow studies- 2 Locations (2002) Acute oral toxicity studies in rats (2003) Mucous membrane irritation test in rabbit (2004) Primary skin irritation test in rabbit (2004) Multi Location Trials and ICAR trials (2004) Subchronic oral toxicity study (2005) Allergenicity study in rat (2005) Multi Location Trials and ICAR trials (2005) Subchronic feeding studies in goat/rabbit (2006) Socioeconomic and risk assessment (Various papers published) Large Scale trials through Ind an Institute of Vegetable Research (2007) The additional environmental biosafety studies and food/feed safety studies have also been completed on Bt brinjal: Fish feeding study (2005) Chemical fingerprinting of Alkaloids (2006) Chicken feeding studies (2006) Lactating cow feeding studies (2006) Germination and weediness studies Aggressiveness studies Soil microbiota studies Substantial equivalence studies Protein expression studies Baseline susceptibility studies Protein detection in cooked fruits Molecular characterization and event ID Limit of detection of event at 0.01% level Crossability with wild relatives The complete biosafety has been submitted to RCGM and GEAC and we are awaiting a hearing. ]]> <![CDATA[GM crops plagued by Biosafety concerns: Greenpeace]]> https://biospectrumindia.com/news/95/5589/gm-crops-plagued-by-biosafety-concerns-greenpeace.html https://biospectrumindia.com/news/95/5589/gm-crops-plagued-by-biosafety-concerns-greenpeace.html Fri, 09 Jan 2009 12:14:00 +0530 GM crops plagued by Biosafety concerns: Greenpeace While one cannot but deny the benefits of technology, it seems it has its risks too, which need to be addressed. In the case of GM crops, a plethora of issues have been raised  on issues of biosafety …  Genetically modified crops or GM crops have been in the eye of a storm in India. It was in August 2008 that the Supreme Court issued a notice to the central government on an application seeking a moratorium on release of any genetically-modified crop till an independent testing lab is being set up in the country. It was only in February that SC had lifted its ban on GM crops and allowed the GEAC to approve new crops and events for field trials after proper guidelines and biosafety norms have been put in place.  The ban was slapped following a petition that complained of genetic contamination owing to the large scale field trials of some GM crops. Bt cotton, the first transgenic (non-food) crop to be commercially released in India in 2002 has been widely debated for its performance, impact on the environment, biodiversity and health of cattle. Bt Brinjal is soon going to be India’s first GM food crop after it clears the biosafety approvals. A host of other crops such as rice, okra and potato are also in the queue. However, there have been constant doubts on the safety of the trials. Trials of Bt rice in the central Indian state of Jharkhand also came under sharp criticism by the Delhi-based nongovernmental organization Gene Campaign in September. According to Gene Campaign’s convener Suman Sahai, an independent survey of the trial sites by her organization revealed serious gaps in the methods of the Maharashtra Hybrid Company (Mahyco), an Indian partner of biotechnology company Monsanto. The threats posed by GM crops in view of the  current regulatory systems have been highlighted in a report by the Yokohama-based United Nations University Institute of Advanced Studies (UNIAS) released during a summit on the UN Framework Convention on Biodiversity in Bonn, Germany in May this year. According to the study lead author, Sam Johnston, India faces a huge risk because safety norms on genetically modified crops are not being enforced which makes the country vulnerable to bioterrorism attacks. Citing the lack of technical, policy and enforcement capacities in developing countries, Johnston said, “If you don’t have the ability to monitor technology, the technology can be used for bioterrorism as you are not biosecure. Just rolling out the technology is not the answer as enormous number of people are resistant to it.” The last few years have seen a spurt in the number of GMOs in India. According to Greenpeace, in 2005 research was focused on 21 crops containing staple cereals, lentils, vegetables, fruits, and the research investment was low. But today rice alone has about 24 different GMOs. Tomato is the second most experimented food crop with 23 events. The other major crops are sorghum and tobacco closely followed by brinjal, groundnut, pigeon pea, potato, mustard, sugarcane, cowpea and soy. Brinjal however is the first crops to go into large scale field trials and is thus anticipated to be the first crop to be approved. Field trials are a long drawn-out process in which companies have to prove that their GM seeds are non-toxic, superior to the natural alternative and environmentally safe. The results have to be approved by the GEAC. Over 236 GMOs, of which 169 are food crop varieties, are in different stages of trials at different private and public institutes in India. The argument While those in favor of GM crops might say they are the answer to the world’s food crisis, opponents of GM crops have their own arguments. Greenpeace released a report titled “Genetic Gamble” in October that delves into the subject of India’s GM food proliferation citing the pertinent danger that inadequately tested GM could pose to consumer health, agriculture, environment, and even revenues earned from food exports. “One of the most glaring regulatory gaps is the system in which biosafety of GM crops is given the least importance. The startling fact is that even after two years of field trials, none of the regulatory bodies have any conclusive evidence on the biosafety of GM rice, okra and mustard.” stated Dr Mira Shiva, Initiative for Health and Equity & Society. They argue that there is no labeling or regulation of imported GM food and that the contamination of organic or non-GM crops are not acknowledged. Unlike EU, where food labeling laws are strict, but still need enforcement, Indian laws are almost non-existent. They argue that there have been no long term studies done to indicate the safety of the first GM food crop of India. And while at the international level, GM food has been either banned or strict restrictions implemented in the European Union, Japan, South Korea and many countries in Africa, India continues to promote GM as the panacea for its food and agriculture problems, said Jai Krishna, campaigner from Greenpeace. Greenpeace advocates that no open air release of GMOs should happen unless there are independent long term health and environmental impact studies conducted and published for an independent public scrutiny conducted on them. Arguments against GM crops A summary of anti-GM views: None of the GM crops that are being developed today in the country are capable of an increased yield. All GM traits are for stress tolerance/ pest resistance/ herbicide tolerance. Yield is not a mere biological trait. No long term tests have been conducted to determine the potential side effects /allergies. Company’s labs produce their own safety studies and deny public access to them. No Precautionary approach. The safety of GM foods are tested after or during open air field trials, where violations have been repeatedly found, leading to irreversible contaminations Does not distinguish GM from non GM. The deliberate release of GMOs means there is no choice left for either the consumer or the farmer to choose. No Transparency: The biosafety tests are done by companies that stand to benefit from the technology and are no published for an independent assessment or allowed a free and fair public scrutiny. GEAC member against MNCs Dr Ramadoss also opposed to the  import of GM food crops into the country.  Following Dr Ramadoss’ announcement, well-known molecular biologist, and the Genetic Engineering Approval Committee (GEAC) member Dr Pushpa Bhargava had written a letter to the Prime Minister Dr Manmohan Singh, urging him to ban GM food crops being imported into the country by pointing out that many of the approvals given to MNCs went virtually unchecked without any safety checks or research. India, being an agriculture intensive country, would be taken over by MNCs.  Bhargava, who was appointed by the Supreme Court to observe the functioning of India’s apex GM regulatory committee, GEAC, has suggested a list of tests to be conducted and also pointed out that less than 10 percent of these tests were actually conducted. Bt  food products in the EU  goes  through a rigorous review to ensure safety, this task is carried out by the European Food Safety Authority (EFSA). EFSA has a panel of independent scientific experts that cooperates closely with national authorities of all member states in analyzing the safety of the products. This panel ensures that the highest standards of safety are applied when testing new biotech  crops. Only products that have been assessed as safe are allowed to reach the market. The French Academies of Medicine, Pharmacy and Sciences stated that no evidence of health problems exist in the countries where Genetically modified organisms (GMOs) have been widely eaten for several years. A recent authoritative study by the European Commission’s scientific advisory body the Joint Research Centre (JRC) reconfirmed the commission’s findings of 2001, that there is no evidence that genetically modified foods have harmful effects on public health and that there is sufficient evidence available for scientists to draw conclusions about the safety of biotech products. The 2001 study by the European Commission had concluded that the use of more precise technology and the greater regulatory scrutiny probably makes them even safer than conventional plants and foods. “India would cease to be a free country if its agriculture is brought under the control of foreign multinational companies” Excerpts from the letter that Prof. PM Bhargava, former director, CCMB   has written to the Prime Minister appraising him of the dangers of unchecked approval of GM crops. Prof. PM Bhargava, expert member, GEAC My dear Prime Minister, I am writing to bring to your notice the dangers of virtually unchecked approval of genetically modified crops in the country that is largely serving the interest of multinational companies such as Monsanto.   This approval is granted, according to the present procedure,  by a Committee of the Department of Biotechnology (DBT) followed by a Committee (Genetic Engineering Approval Committee) of the Ministry of Environment and Forests. There is a public interest petition pending in the Supreme Court (filed by Aruna Rodrigues) asking for a moratorium of a few years on the sale of genetically modified (GM) seeds and approval of GM crops.   In pursuance of this case, the Supreme Court has nominated me to attend the meetings of the GEAC, which has made me acutely aware of our failings in the area. I have provided to the GEAC a list of tests that must be done before a GM crop is approved.   However, only less than 10 percent of these tests are actually being done before approval of GM crops.   Not only that, in the absence of a national facility to do these tests or verify the results of tests done by others, the seed companies  are either doing the tests themselves or having them done by laboratories in the country on samples provided by the seed companies. These laboratories do not have a facility to determine whether a seed is a normal seed or  a GM seed.   Therefore, for all practical purposes, there is no objective way today to ensure safety of a GM crop before it is approved for field trials or commercialization.  We already have incontrovertible evidence that a great deal of damage has been done by Bt. cotton (the only GM crop released so far, with many others, including food crops, in the pipeline) to a section of farmers in India,  as well as to farm animals. Mrs Aruna Rodrigues told me that she had forwarded the list of tests mentioned above, that I had recommended to the GEAC,  to randomly selected well-known scientists who are experts in the field,  for their opinion, along with a copy of the counter-affidavit of the GEAC which said that these tests are not necessary (and which also cast personal aspersions on me!).  She has forwarded to me replies from the ten scientists who were approached by her. All of them, without exception, have unequivocally supported my list of tests; none of them are my personal friends.  I am enclosing copies of the replies of three scientists who are connected with three of the best-known institutions in the world.  I would be happy to send your office all the other replies  as well. I, therefore,  agree with the contention of Mrs Aruna Rodrigues in the above mentioned petition that  is pending in the Supreme Court, that we should have a five to seven year’s  moratorium on the sale of GM seeds and the planting of any GM crop in the country.   During this period, we should set up an appropriate laboratory to carry out all the necessary tests and to verify the results of others that may have been carried out.   I have given to the GEAC a blue-print of such a laboratory which would easily  take five years to be fully operational.  We seek your support to the above proposal. May I in the end say that as India is primarily an agricultural country,  with 60 percent of its  population deriving its total income from agriculture and agriculture-related activities, it would cease to be a free country if its agriculture is brought under the control of foreign multinational companies through control of seed and agrochemical production. The marketing of GM seeds by the multinational companies is a step in this direction.   What is worrying is that as much as 30 percent of our seed production today may be, directly or indirectly, already in the hands of foreign multinational companies. We must prevent this trend. The proposed moratorium would be one important step in that direction.  Yours sincerely, (P M Bhargava) Shalini Gupta ]]> <![CDATA[Debate on GM food crops]]> https://biospectrumindia.com/news/95/5879/debate-on-gm-food-crops.html https://biospectrumindia.com/news/95/5879/debate-on-gm-food-crops.html Fri, 09 Jan 2009 11:51:00 +0530 Debate on GM food crops Dr Anbumani Ramadoss has been dubbed as controversy’s favorite child ever since he was anointed as the union minister of health and family welfare of India, be it the sacking of AIIMS director Dr Venugopal for  reasons obscure and illogical, or the banning of  tobacco on screen,  which did not go well with the film fraternity. Now  Dr Anbumani Ramadoss has captivated media attention again for the wrong reasons. In a recent summit held in New Delhi, the health minister has made an outright statement voicing his dissent and disapproval for the introduction of genetically modified (GM) food crops in India, until proper research has been conducted on them. Anti-GM activists have lauded the health minister’s move. Their main contention is that the transgenic food crops could lead to drastic health hazards in India, they also urged the government to freeze the commercialization of Bt food crops. The health minister asserted, “All GM food must undergo tests in Indian conditions before they are allowed into Indian markets. The Bt brinjal has not been tested in India. I am writing both to the Prime Minister and the agricultural minister about this.” The bioagri companies have slammeda this statement as yet another publicity stunt by the health minister. As the country’s leading biotech magazine, BioSpectrum, in this special cover story, has tried to bring out all the shades of opinion and available scientific evidence to start an informed debate. No scientific evidence to prove Dr Ramadoss’ contention In the wake of the controversial statement, industry leaders have unanimously voiced out that Dr Anbumani Ramadoss has made the statement without any scientific backing and is hell bent on slowing down the technological progress of the industry.  “It is nothing but an attempt to get political mileage,” commented an industry expert who does not wished to be named.  “Research for  GM food crops like Bt brinjal has been going on for six years. The process of checking the biosafety of the crop is exhaustive and intensive.  As far as quality issues are concerned the Department of Biotechnology (DBT) is very stringent in giving approval for the products that come out into the market,” commented Nandkishore Kagliwal, CEO, Nath Biogene, Aurangabad. India is one of the six leading countries that are conducting field trials of GM crops. Besides brinjal, there are over two dozen varieties of rice and an equal number of tomatoes, potato, sugarcane, soy and okra awaiting approval. GM crops like soybean, maize and corn have already been introduced in countries like Australia, Brazil, Canada and US; even after eight years of its introduction there is no opposition or health hazards which are observed. Moreover the transgenic or the residue of the Bt protein within the food crop is so low, that it can in no way lead to any drastic health hazards altogether. “For one kilogram of a Bt food crop, the protein incorporated is just one milligram. So the whole issue of high toxicity and health hazards to humans is redundant,” opined Dr Govind Garg, head, R&D, Krishidhan Seeds.  “I do not see why the health minister has to pass such a statement since it is not his department. Even the food and agriculture department has not passed any judgment and they have also given their approval. I have full faith in the regulatory authority of India and they will consider all the aspects and will not take any hasty decision,” added Dr Govind Garg. Suresh Agarwal, MD, Bejo Sheetal seeds, Jalna, said: “DBT has introduced some rigorous clauses. Before introduction to the market, the Bt brinjal is fed to animals, they are checked in a period of 90 days for any effect. The crops are tested in 60 locations in India. The entire spectrum of trials and tests comes up to approximately to around Rs two crores for a period of five years. So taking all this into consideration, I do not think that Dr Ramadoss’ statement has any meaning.” The ripple effects of the Bt cotton revolution are still being felt in India and industry analysts predict that GM food crops will give birth to a similar revolutionary change in Indian agriculture “Dr Ramadoss along with anti-GM activists is doing nothing but closing doors to a technology which can actually change the face of the industry. In states like Maharashtra and Madhya Pradesh, around 30 percent of  direct oil consumption is from cotton seeds  for the past three years. There have been  no side effects reported.” said Suresh Agarwal. The triggering factor for Dr Ramadoss’ move was the rumors of animals like goats and cows dying when fed with Bt brinjal. This again is a sheer case of  misinterpretation claims industry experts. “Ramadoss claims that the gene in brinjal  caused bacterial damage in the intestine when tested on animals. However this is not the case, because it was clinically proven that the harm was not because of the gene but due to some other factors. Research for Bt food crops has been going on for such a long time and no damages have been reported till date. Such technical and scientific statements should not be  made until and unless it is proven,” opined MG Shembekar, managing director, Ankur Seeds, Nagpur. Why does India need GM crops With the thumping success of Bt cotton, which was introduced five years ago, the bioagri community is confident that Bt brinjal will follow the same path. When Bt cotton was introduced, production of cotton immediately jumped from approximately 160 million bales in 2003  to approximately 310 million bales in 2008. This would not be the case of non-Bt cotton. Since Bt is resistant to insect attack, the wastage of food crops will get reduced and production is expected to increase four-fold. In the case of Bt brinjal, farmers would make an additional income of around Rs 15,000 crore (that is another $3 billion) and they would be saving Rs 5,000 crore of pesticides.  Moreover in a non-Bt food crop, it has been observed that pesticides need to be sprayed around 20 times to prevent the attack of insects thereby leading to detrimental effects on the environment and above all lead to health hazards to humans. “Due to its huge population, a country like India needs increased  food production to cater to the raising demand. If India becomes pro-Bt, then we will not just have increased yield and income but there will be a reduction in unnecessary wastage of crops, the product becomes marketable, there will be economic benefits to the farmer and the socio-economic gaps in the Indian populace will decrease. After visiting several villages and understanding the adverse effects of chemical pesticides in farmers, I am sure GM crops are inevitable,” Dr Govind Garg added. Introduction of Bt brinjal will automatically be an encouraging sign for other Bt crops like Bt okra and Bt tomato. “Our country needs it more than any other country. We need better quality and quantity production of food,” pointed out Suresh Agarwal Unlike the EU and the more advanced nations in the world where the production of non-GM food crops has touched an  all time high and population is low, in India GM food crops is more of a need than just a luxury crop. According to the International Service for the Acquisition of Agri-biotech Applications (ISAAA) report ‘Brinjal is grown on nearly 550,000 hectares in India, making the country the second largest producer after China with a 26 percent world production share. It is an important cash crop for more than 1.4 million small, marginal and resource-poor farmers. Brinjal, being a hardy crop that yields well even under drought conditions, is grown in almost all parts of the country. Major brinjal producing states are West Bengal (30 percent production share), Orissa (20 percent), and Gujarat and Bihar (around 10 percent each). In 2005-06, the national average productivity of brinjal was recorded around 15.6 tons per hectare. Despite its popularity in India, brinjal cultivation is often input intensive, especially for insecticide applications. Brinjal is prone to attack from insects, pests and diseases, the most serious and destructive of which is the fruit and shoot borer (FSB) Leucinodes orbonalis. FSB feeds predominantly on brinjal and is prevalent in all brinjal producing states.’ Loses of up to 70 percent for the farmer has been reported due to this problem. On the other hand, a  Bt Brinjal crop  will bring a full-stop to such problems and resist FSB attack and hence lead to economic gains for the farmer. In a recent conference in Delhi presided over by Sharad Pawar, the union minister of agriculture, two months ago, there was an unanimous opinion that GM food crops are  inevitable in India. “It was a new technology, which would boost the industry, make it insecticide free  and all research is going in that direction. At this point of time industries need government support. Government should have a discussion with all the stakeholders to understand their needs and demands. That will allow us to stand in competition with countries like the US and China. China has a lot of on going work in GM food crops whereas India is somewhat lagging behind. The problem in India is that despite the number of research laboratories and talent, unfortunately there is no positive work happening because of lack of incentives. In China, the government plays a proactive role. The Government of India should encourage public-private partnerships,” opined Shembekar. If Dr Ramadoss has his way, it will be a loss not just to the industry, Indian farmers will get adversely affected. “Bt cotton was a huge success among farmers. The Bt concept was accepted widely by farmers and the GM food crops will receive the same acceptability. Research should fulfill the needs of the farmers and not the needs of politicians,” revealed Shembekar. “It has been accepted among farmers all across the country that the health minister can only delay the process but not stop the technology from being introduced,” said Suresh Agarwal. Current work A lot of Indian companies are already ready to either introduce new GM food crops or are planning to  venture into the GM food crop production. While Mahyco will be the first company which will bring  out India’s first Bt brinjal with the technology licensed by Monsanto. Nath Biogene  is in the process of getting an approval  for its Bt brinjal and within another three years it will introduce it into the market after which they will introduce Bt rice. Jalna-based Bejo Sheetal seeds had started research on Bt brinjal three years ago, and within two years it will launch its product into the market; Bt brinjal will be followed by Bt okra, Bt tomato and Bt cauliflower.  Looking at the multi-facet benefits, Nagpur-based Ankur Seeds is also planning to focus on Bt brinjal and other GM food crops. Bt brinjal was first developed by the Maharashtra Hybrid Seeds Company (Mahyco). The company used a DNA construct containing the cry1Ac gene, a CaMV 35S promoter and the selectable marker genes nptII and aad, to transform young cotyledons of brinjal plants. A single copy elite event, named EE-1, was selected and introduced into hybrid brinjal in Mahyco’s breeding program. Mahyco also donated the Bt Brinjal technology to the Tamil Nadu Agricultural University (TNAU), Coimbatore and University of Agricultural Sciences (UAS), Dharwad. The event EE-1 was back-crossed into open-pollinated brinjal varieties. Mahyco also donated the technology to public research institutions in the Philippines and Bangladesh. Several other research institutions, both public and private have also been developing Bt brinjal using different genes. Several other research institutions, both public and private have also been developing Bt brinjal using different genes. The National Center on Plant Biotechnology (NRCPB) has developed Bt brinjal varieties expressing the cryFa1 gene. The technology was subsequently transferred to companies including Bejo Sheetal, Vibha Seeds, Nath Seeds and Krishidhan Seeds. The Indian Institute of Horticultural Research (IIHR) is also developing Bt brinjal using the cry1Ab gene. Scientists are also looking for ways to develop Bt brinjal in conjunction with other multiple and beneficial traits. Safety concerns of GM foods While GM foods have been branded as Frankenstein foods by their opponents citing that the products are unnatural, potentially harmful to humans and are capable of harming the environment, the arguments in favour of the same aren’t less as well. A study conducted by Lucy Carter at the University of Queensland Australia has founded that  there was no evidence to justify continuing moratoriums on commercial GM planting so long as thorough risk assessments were done. The study found the benefits of GM plants and food outweighed the risks, finding no compelling evidence of harm to humans and environment.  Lauding the benefits that biotechnology has to offer Dr KK Tripathi, advisor DBT, said, “Genetic engineering has given us many benefits including decrease in pesticide use, increase in shelf life and  increase in productivity. As far as the introduction of GM foods in India is concerned, all developing nations are looking towards India.” He refers to Bt brinjal, that is soon to be relased in India after relevant testst have been conducted. “It is the first product of its kind in the world. The benefit of the technology used for Bt brinjal is that there is 90 percent reduction in the pesticide use and 20 percent increase in productivity. Farmers have been asking us as to when will the seed be available to them,” Dr Tripathi added. Dr Vibha Dhawan, executive director, Advanced Biotechnology, TERI, also exudes the same confidence. She  said,” This is a wonderful technology wherein we are trying to mitigate the problem   of insect attack, not by using chemicals but by modifying the crop which is not toxic to human beings, which are targeted only at the insects. In a tropical country like India, the temperature is conducive for microbes and insects and that is one of the reasons that our post-harvest losses are very high and a lot of pesticide has to be sprayed to protect the plants. The introduction of Bt brinjal will reduce the risk associated with pesticide residue, which is very high in a crop like brinjal.” Biosafety is the biggest concern that activists and GM opponents raise when it comes to the release of GM crops. Dr Tripathi feels that we need to look at it with a fresh perspective. “ The issue of safety in case of genetic engineering comes up just because we have changed the genetic structure at the particular place with a particular trait. We have broken the species barrier, so we know that there may be something unintended and hence biosafety tests are conducted.  While in hybrids(genetic modification), we change a whole lot of traits, some of which we don’t know about. So safety issues are relevant in both the cases,” he said.    RK Sinha, executive director, All India Crop Biotechnology Association, advised that with a regulatory set up in place all the worries will be eliminated. “Trials and tests are important and they are being done rigorously by the companies under the supervision of GEAC. It is only after biosafety is proved beyond doubt in regard to health of human being, animals and environment that GEAC gives permission to commercialise a product. The same process is followed in the case of Bt brinjal.”  Talking about the farmers experience with Bt cotton he says, “As far as Bt cotton is concerned , the experience of the farmers is overwhelming. It is giving them returns in terms of productivity, yield etc. As far as food safety is concerned, GM food has been there for more than a decade the world over. No adverse effect has ever been reported. If it is safe for the outside world, it should be safe for India as well.” Nayantara Som with Jahanara Parveen and Shalini Gupta ]]> <![CDATA[The year ahead]]> https://biospectrumindia.com/news/95/2514/the-year-ahead.html https://biospectrumindia.com/news/95/2514/the-year-ahead.html Fri, 09 Jan 2009 11:18:00 +0530 The year ahead Year 2009 promises to be a 'Year of Consolidation' for life sciences industry in the Asia Pacific region. While Big pharma will continue to downsize as patents expire and new products come to market slower, biotech companies will learn to sell their IP cheaply, merge, find synergies or die as they run out of money. The year rings in consolidation with capital â€œCâ€? The US economy has entered a prolonged period of recession and will remain weak for most parts of 2009. This will possibly extend into 2010. It is likely that the conditions experienced in 2008 (limited availability of capital from debt and equity markets) will continue to persist. According to Dr Louis Payet, Senior Consultant, Healthcare Asia Pacific, Frost & Sullivan, the capital availability for small-to-mid size development stage life sciences companies will lag the broader market and these industries will remain under funding-pressure for a significant period of time. He says, even though year 2009 will remain challenging for companies in the healthcare sector due to declining government expenditure and weakness in the healthcare insurance sector the industry in Asia, in 2009, will continue to grow. Stagnant and challenging markets in the US (and EU) will drive the companies in these regions to increase their focus on growing Asian markets. The financial crisis will however broadly slow the growth of the region's major markets such as China and India. The overriding factor that will modulate the growth of the sector in Asia will be access to funding. Even though US, EU and Japanese companies may see the region as critical to their growth, their ability to develop their operations here will to a great extent be determined by their access to funding. Small-to-mid size Asian companies with access to strong customer bases, manufacturing capabilities or innovative products will fare better. Also, a continued drive towards personalized medicines is likely to result in the emergence of new technologies in the diagnostics and medical IT space. Diagnostic technologies providing patient specific analysis (such as characterizing drug resistance in infectious disease suffers) will see increasing demand due to their ability to improve patient therapeutic outcomes. The need to streamline the analysis of large amounts of patient data will also drive the development of complementary IT systems designed to support large scale data analysis and the subsequent automated output of concise analytical reports. These systems will provide medical practitioners with timely results that can be used to make patient specific treatment decisions. This trend towards 'personalized medicine' will be encouraged by governments, as optimal application of costly therapeutics can result in lower healthcare costs. In the following pages of this special issue, BioSpectrum fast forwards 2009 to capture a first person account of what the industry insiders are anticipating in the year ahead. Forced M&As will rise: Burrill Year 2009 is a time of great opportunity and many changes. Overall, the industry will see consolidation, a forced consolidation at that. There will be hectic M&A activity and outsourcing to Asia will pick up speed. India and China will rise as the preferred R&D destination. The year 2009 will also see reduced research and development spending and fewer and expensive capital raising If I look at the projections that I have done in the last 10 years, I have been spot on. They have all been 100 percent correct. Earlier, in 2008, I said this will be a boom year for mergers and acquisitions and it was. One of my projections for 2008 that shocked many was the implosion of the capital market and the bust after that. We have been very accurate in our projections on industry, change in the economic environment and so on. I see year 2009 to be a challenging year. I am not writing the obituary for the year or for the industry or the transactions. In currency terms, there will be more transactions done, more deals done globally but these will be of different scale and not of the same type in dollar terms. These will be very different from what we have seen so far. Forced M&As will rise To be able to say what is going to happen in the R&D and M&A arena in 2009, you have to put the backdrop in perspective. You have to consider the last year. In 2008, there were two halves-the first half where the economy actually tanked, and the second half where we had to deal with the massive downturn. In the second half of 2008, we had a substantially reduced capital regime where we had just one IPO in the US and a few elsewhere in the biomedical arena. We had a reduced capital spending period and broadly tougher economic environment. We had relatively few big deals and R&D spending had come down. In 2009, we will see reduced R&D spending, lower, fewer and more expensive capital raising activities. Power of the entrepreneurs to raise capital will be greatly reduced. Going forward, we will see consolidation. We will see M&As forced on companies on some reasonably attractive terms. However, there will be some others who will file for bankruptcy and call it quits. We will see attractive deals in the higher end of spectrum and the action moving to the global stage like Indian companies doing business with Indian companies and Indian companies doing business with Chinese companies. Business models will change The pharma model that you and I have known historically is in for a big change. We will see big companies disintegrating or selling away parts of their companies or spinning-off parts of their company into new companies. We will see integration of different slices of the value chain and change in business models. We will see companies merging with equals and keeping products that sell and getting rid of products that don't make sense. We will also see big companies buying big and small companies, biotechs buying small companies and small companies itself coming together. We will see consolidation all across along with a high level of M&A activity. Outsourcing to Asia will rise Outsourcing to Asia will pick up speed. We will see more healthcare expansion in Asia-India and China in particular. We will see more entrepreneurship and innovation in Asia. Both large and small markets in Asia will benefit from a relatively changing world. Obama to inject life into the industry (exclusively as told to Sanjeev Jain, ) The Obama administration will be positive for the US and the world. The new administration will bring in positive changes. Healthcare reform is on priority for the Obama administration. These will give stimulus to the industry. Healthy growth ahead, in spite of slowdown: KPMG The Asia Pacific (APAC) pharma and biotech segments of the life sciences Industry has attracted substantial interest from global players in the industry and already is, (inclusive of Japan), the third largest regional market after North America and Europe. The percentage of Asia's population defined as elderly is increasing very rapidly. There are industry estimates which suggest that as much as $50 billion will be injected into the Asia Pacific life sciences markets from both public and private sources over the next few years. The race is clearly on among Asia Pacific countries as they seek to position themselves as genuine global pharma and bio-environments. The success of Asian pharmaceutical companies can be attributed to their low cost, high quality advantage that made them leading suppliers/ exporters of Active Pharmaceutical Ingredients (APIs) and formulations globally. The biopharma segment accounts for a major share in the APAC biotech market and the region is expected to become a major destination for stem cell research and biogeneric manufacturing. It is also expected to play a dominant role in the antibody therapeutics development. Major focus is being centered on gene therapy, agri-sciences, bioinformatics, genomics and proteomics. Growth in the scientific advancement and capabilities clubbed with a very large patient pool (Asia accounts for more than 60 percent of the world's population) marks Asia as one of the preferred partner of choice. The APAC region as a whole and predominantly India and China have emerged as favored off shoring/ outsourcing destinations for various pharmaceutical activities like Contract Research and Manufacturing Services, (CRAMS), and Clinical Trial Services. Given the opportunities on offer, many countries in the APAC region have expressed their intent to become pharma and/ or biotech hubs and countries like Australia, Japan, South Korea, China, Singapore, India, Taiwan, Malaysia, Hong Kong and others have set up growth plans for this sector. They have set up pharma and biotech clusters, sometimes with government support for research, in order to enhance their industry capabilities. For example, China is already the largest vaccine manufacturing country in the world. Many big Indian pharma companies have also started venturing into biotech. India has the third largest pool of technically qualified manpower, which augurs well for the need for larger numbers of skilled human resources, which will be required to keep fuelling the growth in these knowledge-based industries. Apart from this, the regulatory environment in Asia Pacific countries particularly in India, China and Japan are at par with global standards as well as the availability of skilled manpower and infrastructure has also contributed towards the success of this region. The recent reforms in the area of Intellectual Property (IP) protection have further instilled confidence and MNCs are now investing heavily in this region. The APAC pharma market is expected to grow by 9 to 12 percent over 2006-2010 as compared to North America and European markets that are expected to grow at five to eight percent. Some of the key markets within the Asia Pacific region include China, India, Japan, South Korea, Taiwan and Australia. Smaller regions like Singapore, Malaysia and Vietnam are also budding markets within this region. The biotech market in the APAC region is further expected to grow by 10 percent in 2008, with Japan making the largest contribution. Some of the key markets in this region include Japan, China, Australia and India. The Korean government is aiming to join the world's top seven biotechnology powers by 2010, Taiwan is earmarking three percent of GDP for life science development and Singapore wants to have an increasing share of the global scientific community. China is also making a concerted effort to raise the standard and profile of its local biotechnology industry. The APAC region has also succeeded in capturing a larger pie of the global pharmaceutical and biotech industries on account of a large number of global pharma companies resorting to cost cutting measures due to mounting cost pressures and relocating their manufacturing and research bases to this region. Even as MNCs are setting up their operations in Asia, the domestic APAC companies are constantly expanding their global reach and are acquiring a larger share in the international markets. Crystal ball gazing into 2009, one can expect the market to grow further in spite of the global economic slowdown on the basis of increase in the demand for pharmaceutical and biotech products that would largely be driven by rapid growth of population and longer life expectancy coupled with changing lifestyle pattern due to increased urbanization and changing demographics will contribute to a healthy clip in sales growth. Outsourcing to Asia will intensify:PwC Sujay.gif With the US downturn, the movement of business to Asia will intensify. Cash rich Big pharmas will be making an effort to boost their stagnating R&D pipeline and will be the key driver in increased outsourcing to Asia. Contract Research and Manufacturing Services space (CRAMS) will also see a spurt in investments. In the M&As arena big pharma will be focused on two things: augmenting their R&D pipeline and increasing their exposure to India and China. With valuations correction and stock prices coming to their realistic prices, a good number of deals are just waiting to happen. If you look at international scenario, acquisition activity has been quite strong when it comes to MNCs buying out smaller yet innovative biotech or pharma companies and could even see big pharma firms acquiring or merging with equally big rival. This is a very likely possibility in 2009. Another possibility is consolidation amongst small and medium sized firms. Among the SME players, merging their strengths to survive is a route many will take. They will take this route to progress their research and compounds to positive results. Year of Consolidation Nandita Singh, Narayan Kulkarni,  Sanjeev Jain & Shruthi Ram ]]> <![CDATA[The Year that Was]]> https://biospectrumindia.com/news/95/1932/the-year-that-was.html https://biospectrumindia.com/news/95/1932/the-year-that-was.html Fri, 09 Jan 2009 11:10:00 +0530 The Year  that Was The year 2008 turned out as an eventful period that brought in a gradual metamorphosis to the life sciences industry. Other than the usual drug discovery collaborations, mergers and acquisitions and launching of new products into the market, 2008 saw a change in perspective, business dynamics and strategies of the entrepreneurs. India is gradually coming out of its shell of isolation and emerging as a major player in the global life sciences industry. The landmark deal between Ranbaxy and Daiichi Sankyo is considered as one of the major events. By selling the majority stake to Daiichi Sankyo, Ranbaxy, the Indian generics giant paved the way for Indian pharma to enter the innovative drug space. In the purely biotech space, we have seen the active implementation of the National Biotechnology Development Strategy (NBDS) under the aegis of the Department of Biotechnology (DBT).  The World Health Organization’s (WHO) ultimatum to the National Regulatory Authority (NRA), on the backdrop of the closure of three public sector vaccine making units because of its appalling Good Manufacturing Practice (GMP) standards, came as a death threat to the vaccine industry. The recent setback has been the global meltdown, which has influenced all segments to an equal extent. According to the Biospectrum-ABLE Survey 2007-2008 the biotechnology industry in India has witnessed a 20 percent dip in its growth. Though experts claim that life sciences is an industry which is ‘recession proof’ ripple effects can still being felt. A sneak peek into some of the milestone events of 2008... National Biotechnology Development Strategy It was implementation time for DBT. The announcement of the NBDS in November 2007 was widely welcomed by the industry, as they believed that it would bring about a radical change in the landscape. Initiatives taken by DBT have led to the formation of tie-ups between the industry and the government, which were unseen in the past. The end of the year also saw the cabinet clearance of BIPP (Biotech Industry Partnership Programme) with a sum of Rs 350 crore earmarked for the scheme during the 11th Plan thus paving the way for technological development and innovation in biotechnology. As a principle, BIPP would strictly promote high risk, transformational technology/process development. No incremental development will be supported. On a broad basis, it is directed at path-breaking research in futuristic technology that has major economic potential to make Indian industry globally competitive and aims at Intellectual Property (IP) creation with ownerships by Indian industry and where relevant, collaborating scientists. Rejuvenating Research Dr M K Bhan, secretary of DBT, Government of India, and Dr Mark Walport, director of the Wellcome Trust have initiated the £80m (Rs 640 crore) scheme, jointly funded by the DBT and the Wellcome Trust over five years, with the aim to strengthen the research base of Indian biomedical science by providing fellowship programs to support researchers ranging from newly-qualified post-docs to senior researchers. Each year, the alliance is expected to award around 40 early career fellowships, 20 intermediate fellowships and 15 senior research fellowships. In addition to the new fellowship schemes, the Wellcome Trust has introduced Strategic Awards totaling £15m (Rs 120 crore) to boost the biomedical research in the country. Indian Gene Decoded The largest ever study to understand the genetic diversity of India’s one billion population, which was conceptualized by Dr Samir K Brahmachari, the director-general of CSIR and Dr Lalji Singh, who heads the Center for Cellular and Molecular Biology (CCMB), was unveiled. The highlights of the study were published in the April issue of the Journal of Genetics, published by the Bangalore-based Indian Academy of Sciences. “Our study reveals a high degree of genetic differentiation among Indian ethnic groups and suggests that pooling of endogamous populations without considering ethnolinguistics factors will result in false inferences in association studies,” said Dr Samir K Brahmachari, one of India’s leading geneticists. The study included 32 large populations of sizes above 10 million people and 23 isolated tribal populations representing the vast ethnic, linguistic and geographical diversity of India. “India represents a global genetic mosaic in its population. The Indian population forms a continuum of genetic spectrum that not only bridges the Caucasians and Oriental Asians and also includes indigenous populations derived mostly from Austro-Asiatic and Dravidian speaking population,” said Kapil Sibbal, minister of science and technology who unveiled the study. The findings of the study will facilitate the clinical trials to test the efficacy of drugs in all major populations in India. The data is expected to help the construction of specific drug response maps to aid policy level decision making for drug dosage interventions and disease risk management for complex as well as infectious diseases. CROs chant globalization mantra Contract Research Organizations (CROs) have revamped their business strategies wherein they are looking at strategic alliances and partnerships with pharma companies and smaller organizations to augment their business. As a part of their business model, Siro Clinpharma is first setting shop in Eastern Europe and other non-traditional countries--all of which provide the same advantages like India. Siro has acquired Omega Mediation Group, a mid-sized European CRO for an undisclosed amount. Joining  the club are Jubliant, Veeda Clinical Research and Ahmedabad-based Synchron. Vaccines Issue The vaccine industry was hard hit this year with the World Health Organization (WHO) giving an ultimatum of October 2008 to the Indian regulators (in this case the NRA) to revamp the regulatory system to avoid derecognition of the NRA. This has come in the event of three substandard public units being shut down resulting in many applications put on hold. In a country, where only 10 percent of the children are vaccinated, this can snowball into a serious issue. BioSpectrum was the first to bring to light this issue in an industry forum, which saw an assemblage of almost all the stakeholders in the industry. The latest now on the vaccine front is that vaccine makers are now given a five months breathing space (till March 31, 2009) wherein the DCGI can upgrade the regulator’s testing labs. Emerging R&D centers The year 2008 has seen a lot of Indian and multi-national companies establishing their R&D centers here, making it clear that India is poised to become the R&D hub of the global life sciences industry. DuPont India, a subsidiary of E I du Pont de Nemours and Company recently opened the first biotech research facility at the DuPont Knowledge Center (DKC) in Hyderabad, spread across 15 acres with an investment of Rs 100 crore. It’s still relatively early in the movement of R&D to India but with a focused and a long-term R&D vision, policy framework and commitment coupled with the incentives, which the Indian government is offering, India can go a long way in becoming the biotech R&D hub of the world. National Biofuel Policy approved It was in 2003 that India started its Biofuel mission. Five years later, the Union Cabinet in its meeting held on September 11, 2008 gave its approval for the National Policy on Biofuel prepared by the Ministry of New and Renewable Energy, and also approved the setting up of an empowered National Biofuel Coordination Committee, headed by the Prime Minister of India and a Biofuel Steering Committee headed by cabinet secretary. Ministry of New and Renewable Energy has been given the responsibility of the National Policy on Biofuels and overall co-ordination by the Prime Minister under the Allocation of Business Rules. A proposal on “National Policy on Biofuels and its Implementation” was prepared after wide scale consultations and inter-ministerial deliberations. Group of ministers (GoMs) under the chairmanship of the Union Minister of Agriculture, Food and Public Distribution, Sharad Pawar, considered the draft policy. After considering the suggestions of the planning commission and other members, the GoMs recommended the National Biofuel Policy to the cabinet. Mergers and Acquisitions The year 2008 has witnessed some groundbreaking mergers and acquisitions and the prominent among them is the Ranbaxy-Daiichi Sankyo deal. Industry analysts predict that this could mark the beginning of a new era where second generation entrepreneurs will look at issues on a macro level thus changing the landscape of the pharma industry. Nayantara Som with Shalini Gupta and Jahanara Parveen ]]> <![CDATA[â€œWe believe that our sales in India will grow rapidly in 10 yearsâ€?]]> https://biospectrumindia.com/news/95/2371/we-believe-that-our-sales-in-india-will-grow-rapidly-in-10-years.html https://biospectrumindia.com/news/95/2371/we-believe-that-our-sales-in-india-will-grow-rapidly-in-10-years.html Fri, 09 Jan 2009 10:32:00 +0530 “We believe that our sales in India will grow rapidly in 10 years” —Marijn E Dekkers, president and CEO, Thermo Fisher Scientific Marijn E Dekkers, president and CEO, Thermo Fisher Scientific (TFS) was recently in India for the inauguration of the clinical trials facility in Ahmedabad. In an exclusive interview with BioSpectrum, Dekkers talked about the TFS’s new line of products, its strategies to tackle the financial crunch and the promise that India holds for the company’s overall growth With the expanded product portfolio, is TFS going to leverage its strengths in the key segments? At present we are focusing on stem cells and all the tools related to stem cell research. There is lot being done in  vaccines and vaccine production, it is a growing area, especially in India where most of the pharma companies are moving into biotechnology. The CROs are growing in India that is why we are opening a new factory in Ahmedabad and that is clearly to support clinical trials as we do a lot of sample management and logistics for medicines that are used in clinical  trials. In the last year we have done  two acquisitions Qualigens and Chemito; Qualigens in order to get bigger in laboratory chemicals and Chemito to have manufacturing capabilities and product development capability in scientific instruments in India. It is a difficult period for all industry segments with the financial crunch. Globally, how will the company align itself to the situation? We are in a strange situation because there are two things happening at the same  time. The economic slow down and a credit crunch. Normally when  there is a recession, it does not mean that there is a credit crunch. I feel it’s an over reaction which is temporary. From our company point of view when compared to other industries, usually in such a situation we do not tend to be vulnerable because life sciences  and healthcare are not affected as people will not stop buying medicines. When you look at the breakdown of our sales, half of our sales are consumables and that is recurring revenue, another 15 percent of our sales is in services and 35 percent of our sales is from incrementing capital goods that comes out of our capital budget and those tend to be the area where people say let’s be careful and not invest. Fortunately that is only one-third of our business.  Pharma companies are under a lot of pressure as far as costs and drying up pipelines are concerned, so suppliers of products will have to be efficient as to how they sell their products to this industry.  The pharma industry is a fragmented industry both from the suppliers and buyers point of view. There are a lot of suppliers selling a lot of different things to different pharma companies, there will be a lot of consolidation in this segment not just pharma but also in biotech and academic institutions people need to be smarter. What is the strategy behind TFS’s acquisitions? We believe that larger companies with a broader portfolio will be able to serve customers better. Thermo Fisher has been acquiring small and medium companies. While we are acquiring companies we give importance to technology and the geographical location. Even though we do have the capabilities and technology in the US and Europe, we didn’t have the technology in India, so the buyout was more of geographic decision as we are eager to grow our capabilities in India. What are the new products in the pipeline?  We have a lot of areas where we are focusing our R&D, scientific instruments and particularly mass spectrometry is one such areas because the analytical side has the most opportunity for innovation. I am also excited about RNAi technology  that is a new way of identifying bad genes and we have a strong library of RNAi molecules that researchers are using to study genes. Those are the two key areas that have a lot of potential. We are also giving special emphasis to user-friendliness as customers prefer user-friendly instruments. What in  your opinion is the challenge for the next  5-10 years? The customers need  to be more efficient. In pharma for example a lot of money is being spent on R&D and the pipeline is not what it should be, the pressure is always there. So here it is not always about technology its also about productivity. We should be in a position to provide the customers  with not only technology but also the benefits of efficiency and productivity.  Second, our customer base is getting more global. Around 10-15 years ago India and China were very small countries in terms of an opportunity to sell, Now it is growing bigger and as a supplier you need the capability, energy and money to invest in nations like these and sometimes it gets hard to sell in such countries, hard to invest all resources and service spare parts and that’s a challenge and we are focused on being global. Do you think that the days of blockbuster drugs are over? The days are not fairly over but there maybe biotech blockbusters. Every industry goes through a rapid development for new molecules for a period of 30 years or so and I think indepth knowledge of the life sciences industry, which is not present as of now can create a whole cycle of innovation for the next 20-30 years. Life Sciences is going through the same cycle and we could see small molecules as the step towards personalized medicines.   N Suresh and Nayantara Som in Mumbai ]]> <![CDATA[â€œBioethanol can do a world of good if produced sustainablyâ€?]]> https://biospectrumindia.com/news/95/2850/bioethanol-can-do-a-world-of-good-if-produced-sustainably.html https://biospectrumindia.com/news/95/2850/bioethanol-can-do-a-world-of-good-if-produced-sustainably.html Fri, 09 Jan 2009 10:13:00 +0530 “Bioethanol can do a world of good if produced sustainably” —Peder Holk Nielsen, executive vice president, enzyme business, Novozymes A/S, Denmark Peder Holk Nielsen, joined Novo Industri A/S in 1984 as an assistant product manager in the Enzymes Division, and has served the organization in various roles before being appointed as director of the New Business Development Group in 1988. He was appointed as vice president of Industrial Biotechnology in 1990 and as vice president of R&D in the Enzyme Process Division in 1993. And between December 1994 and December 1998 he was corporate vice president of Enzyme Development and Applications. In 2000, Nielsen was appointed as executive vice president, business operations in Novozymes and in 2007 he was appointed as head of Enzyme Business. Peder Holk Nielsen was recently in India to be a part of the silver jubilee celebrations of the company’s operations in India. Nielsen shares his view on the various opportunities in the enzymes business. What are some of the characteristics of the Novozymes’ story? This company has made a significant commitment over the past few years to becoming more customer-centered. Yes, that sounds like a cliche, but for us it is the main reason why Novozymes has become an independent company. The old structure, where we were a business division of Novo Nordisk, made sense as long as the challenge was to exploit a common production technology to the maximum. But the business has changed, and our new structure gives us far more freedom to find strategic partners. The way we carry out our business is through long-term commitment. The culture of this company is being customer-oriented and everybody including production and R&D understand that serving customers is the way of life. We imagine a future where our biological solutions create the necessary balance between better business, cleaner environment and better lives. You are celebrating 25 years of successful operations in India. Can you trace the journey? Novozymes has had a presence in the Indian market for a long time. As far back as 1983, the first enzyme activities were established in Bangalore. In 1992, we expanded as a wholly owned subsidiary of Novozymes A/S  and had six people in India chasing big dreams. The Novozymes’ Indian headquarters is in the International Technology Park, Bangalore, and we also have production and repackaging facilities at other locations in Bangalore. We also started R&D in 2005. The year 2007 has been a landmark year for Novozymes in India. We acquired Biocon Ltd’s enzyme activities and strengthened our operations and resources. That was one of the largest acquisitions for Novozymes. With it, our position and opportunity for harnessing the rapid growth in the Indian market has become even stronger. Today we have around 235 people in the India operations. What are your observations on the enzymes business opportunities in India and Asia? The use of enzymes is still limited in the country, but India’s increasing prosperity offers good potential for growth. Biocon’s enzyme activity acquisition has made our position strong in the Indian enzyme market with a good distribution network and channels, local application knowledge and a global position in enzymes for the wine and juice industries. Although the use of enzymes is still at a relatively low level, interest in the benefits of using enzymatic solutions in India is intensifying. In India, the laundry, alcohol and textiles industries are using enzymes and there are going to be newer applications too. Asia is growing in importance for Novozymes and the sales in the region have grown by an average of 10 percent per annum over the past few years. The opportunity can be gauzed by looking through the eyes of the customers. There is a lot of excitement in significant markets like Asia. China, India, and South East Asia. There is a lot of activity in the biofuels sector. Can you comment on some of your initiatives? Novozymes uses biotechnology to improve the use of resources in more than 30 industries around the world. The biofuel industry is one of them. Novozymes sees bioethanol as a major step towards meeting increasing needs with limited resources, if done the right way. Novozymes offers what is likely to be the most efficient technology platform to further improve the sustainability performance of bioethanol production. The use of enzymes in the bioethanol industry is a mature and proven technology. Nonetheless, there is still great potential in the use of enzyme technology to further optimize and improve the bioethanol production. Is bioethanol mature enough to be a major source of biofuel? Bioethanol is based on renewable resources and can reduce our dependency on fossil fuel. By 2030 bioethanol can meet 25 percent of the global need for energy for road transport and a lot more as vehicle fuel economy improves. First-generation bioethanol is produced from crops such as sugar cane/beet, corn, wheat, barley, rye, sorghum, and cassava. This technology is in place and all commercial production of bioethanol is currently first generation. Second-generation bioethanol is produced from feedstock containing cellulosic biomass such as the stalks, leaves and husks of corn plants, wood chips, and sawdust. Second-generation bioethanol may also be produced from energy crops such as switch grass. The advantages of energy crops include their need for less fertilizer and the fact that they can be harvested several times a year. Enzyme technology is constantly developing, and Novozymes expects that the enzyme technology for commercially viable production of second-generation bioethanol will be on the market in 2010. Novozymes was awarded a $12.3 million contract from the US Department of Energy (DoE) to improve the enzymes necessary to produce cellulosic ethanol. Novozymes’ project DECREASE (Development of a Commercial-Ready Enzyme Application System for Ethanol) aims to improve the performance of enzyme systems, to further reduce the cost of cellulosic ethanol production and supply new and commercial cellulases in pilot, demonstration, and commercial plants by 2012. What are some of your initiatives in the biofuel sector in Asia? The United States, Brazil, and China have defined clear targets and roadmaps for the development of the bioethanol industry. By 2010 China aims to double its bioethanol production to cover five percent of the total transport fuel used with a target of three million tons of fuel ethanol. China currently produces roughly the same amount of bioethanol as all the EU countries put together, and we expect China to become an important market for enzymes for the production of bioethanol. As China has to import maize (corn) and cereals for food use, there is a great deal of interest there in developing the technology for producing bioethanol from plant waste (biomass), the second-generation bioethanol. In 2006, Novozymes entered into a three-year cooperation agreement with China Resources Alcohol Corporation (CRAC) for the development of this technology. Among other things, the agreement means that Novozymes and CRAC have created a development team to work at a pilot plant set up specifically for this project. We inaugurated the world’s largest enzyme fermentation facility (Hongda) in China recently. The facility, Suzhou Hongda Enzymes Co., is located in Taicang, Suzhou, Jiangsu Province, about 50 km north of Shanghai. The expanded capacity will primarily focus on products for the bioethanol industry, with the expansion signaling an investment in both bioethanol and the expanding Chinese market. The Hongda facility in Taicang has been expanding and has more than tripled its headcount. The Suzhou facility is one of Novozymes’ strategic manufacturing locations, and this new expansion will enable us to accomplish more. N Suresh and Ch. Srinivas Rao ]]> <![CDATA["The size of the Indian market is quite important"]]> https://biospectrumindia.com/news/95/1908/the-size-of-the-indian-market-is-quite-important.html https://biospectrumindia.com/news/95/1908/the-size-of-the-indian-market-is-quite-important.html Fri, 05 Dec 2008 17:37:00 +0530 New Page 1 "The size of the Indian market is quite important" -Frank H Laukien, president & CEO, Bruker Corporation Headquartered in the US, with major facilities in Germany with worldwide sales and service centers, Bruker offers a whole range of mass spectrometry tools for use in pharmaceutical drug discovery and development, proteomics and biomarker discovery. The company has completed a decade of operations in India and is aggressively expanding its services, setting up facilities and entering into research collaborations with the scientific research institutions in the India region. Excerpts: So what brings you here? This is particularly to visit and listen to some of our key customers mainly the Indian Institute of Science (IISc). We are organizing a customer symposium and a mass spectrometry symposium here, both in mass spectrometry, and also strengthening our collaboration with IISc. IISc recently opened a new NMR centre and also some new X-ray equipment in collaboration with us. We are really in an extensive collaboration with Indian Institute of Science. We are also launching our new mass spectrometer, which we introduced at the American Society for Mass Spectrometry in June and in Europe proteomics meeting in August, in the Indian market. Last but not the least we are strengthening our organization and operations. We are opening a new Bruker facility in Mumbai for x-ray, optics and infrared business. We are also strengthening our collaboration with our distributor Labmate Asia. What are Bruker's product offerings in this region? In India we have been involved more in NMR mass spectroscopy for over 30 years now. We have extensively expanded our x-ray business here. So that business has been growing very rapidly. The mass spectrometry business together with Labmate has also gone to the next level. We are one of the two world leaders in proteomics mass spectrometry and recently announced some of those products for clinical research applications, microbiology, pathology and the small molecule applied market. Mass spectrometry is young but growing very rapidly. How do you see the competition in this market? We have distinguished ourselves with a higher degree of investments in R&D, not just re-engineering of products. We keep introducing new revolutionary techniques like the biogenic probes that are actively shielded or the magnets for NMR that created a big difference in the NMR field or the new Maxis, the new mass spectrometer which is really unprecedented as it enables you to do a high performance mass spectrometry which nobody has ever been able to do. Where do you stand in the mass spectrometry business? In the mass spectrometry market, we are a relatively a newcomer because most of the companies have been in this space for more than 40 years. We are a little over 15 years and one of the two leaders in the proteomics mass spectrometry. We are the worldwide leader in MALDI and TOF and MALDI-TOF mass spectrometry, not just in proteomics but also in genomics. We are one of the two leading companies in ion trap mass spectrometry. We are also a market leader for 4A mass spectrometry, somewhat specialized niche for very complex mixtures both in proteomics and new fields like petroleomics for metabolic mixtures and the first instrument of that type has been installed at the IISc about three months ago. That is the first FTMS in India as far as I know. In the last few years we have been able to build a very strong customer support here in the research institutes, pharma, generic and CROs. We have very strong applications. We are offering not only service support but also high-level application support. You have recently acquired a company. What is your strategy? The SIS is the fifth product line. This is something that Bruker has not done before-the atomic force microscopy. SIS now called as Bruker Nano, had a very nice technology base with relatively modest sales but did not have the extensive international sales that Bruker had, so we combined them with Bruker and this immediately gave them a global availability to support and collaborate with customers. So through that acquisition we made the right access of the technology to the right group of customers. In future you may see this as the fifth division of Bruker. Acquisitions are always exciting expansions of the market and also to bring technologies to those markets. We acquire only those technologies, which fit into our existing customers. We will keep our eyes open for similar possibilities in future. How has the analytical instrument market transformed over the years? Today, it is clear that the customers just don't want an analytical piece of instrumentation but a solution. About 10 years ago we gave them an instrument with basic software. Today, we don't stop there but give them a database and advanced software processing. So every company has expanded its product offerings. We now give them an analysis system. We give them data and an enhancer. So at the front end, with sample preparation, consumables, we tend to offer them a broader range and provide them more complete solutions than just the equipment. Also the market has become much more international today. If a pharma company in the US collaborates with a company here or China and looking for similar products that they are having in the US, you have to address those global collaborations, go more international and serve them in those regions as well. That is the reason why we are investing not only in India but many other regions for providing similar quality service everywhere when needed. Are you planning for further expansion in India or the Asia Pacific region in life sciences? That is one of the reasons why I am here in India. We are looking to further expand our collaboration with Labmate and customers here. We have quite a number of smaller offices here, and now combining them under one larger facility in Mumbai. Labmate has been a good partner so we are exploring a joint venture possibility with them. In X-ray and IR we have mostly gone direct and so expanded our subsidiary here, which was smaller earlier. Will you be looking at creating a direct presence here in the coming years? We are very pragmatic. If we have an excellent partner that invests in the high level operations and quality support and service support with the scientific expertise needed to address our customers then we will be very happy to go ahead in that. Today India is becoming a very important market for all. What are some of the challenges that you faced in the country? It takes time to establish a company in India when compared to Singapore, which is aggressive in terms of recruiting companies or in permitting tax-free deals for ten years. However, to us it hasn't been an important issue. The size of the Indian market is quite important. How big is your life sciences business in terms of revenue? Our total business is more than $1.1 billion and life sciences contributes more than 75 percent of this figure. In normal times, we typically aim to have a growth rate of more than 10 percent. However in some years we have grown 20 percent. Last year we grew 15 percent. Right now there is a lot of economic uncertainty but that hasn't affected our industry so much. Life sciences is not immune to it but little shielded. But it will certainly affect us and our customers to a certain extent. We are certainly assuming a slower growth in 2009. Years 2005 and 2007 were extremely good years for our sector. When the market today is growing at the rate of 7 to 8 percent we expect to grow at 10 to 15 percent because we are bringing new products, technologies and entering new market segments. Jahanara Parveen   ]]> <![CDATA["We want Indian Biotech industry to get a new dimension"]]> https://biospectrumindia.com/news/95/1887/we-want-indian-biotech-industry-to-get-a-new-dimension.html https://biospectrumindia.com/news/95/1887/we-want-indian-biotech-industry-to-get-a-new-dimension.html Fri, 05 Dec 2008 16:10:00 +0530 New Page 1 "We want Indian Biotech industry to get a new dimension" Dr M K Bhan, who's been at the helm of formulating the National Biotech Development Strategy, gives us a clear view on BIPP and its purpose. Here are the excerpts from the interview with him. What was the idea behind setting up BIRAC? We wanted to change the role of DBT so that it is directly and effectively an instrument of R&D and innovation within the companies particularly SMEs. What we did with BIRAC is to say that we create a new organization, which has DBT, ABLE, BCIL as core partners. Their role in BIRAC is independent of their role as an organization. This organization (BIRAC) is distinct from all organizations and it has its own entity and own purpose, which is unique to it. We are doing two things here. We are creating two organizations. DBT, which is the national funding agency, funds all kinds of life sciences research. We will create an agency, which will become the innovation management agency of the government in biotechnology. This agency is BIRAC. So BIRAC will not only operate our industry R&D schemes, it will provide innovation link service, tech transfer, IP, service support and advice for new companies, provides regulatory advice, clinical trials support and field trials thus covering the whole value chain. DBT will manage the science function and BIRAC, the innovation management. 30 percent of DBT's budget in future will be spent through BIRAC and 70 percent through DBT. This is our goal and we have to move towards it. What would be the priority areas that BIPP would concentrate upon? First of all the project has to be innovative. For example, a novel platform for diabetes, a novel way of delivering cancer drugs, a new way of designing immunogens for vaccines, a new manufacturing process, in short something that will be innovative for future, a generic technology that will have wide effects like drug discovery through systems biology, biomarkers, gene therapy, and stem cell therapy to name a few. It has to be something that we don't do well now and that cannot be done through a usual kind of a partnership. It has to be something that a company won't go easily into because of its high complexity. We shall be measuring selection of the projects by their potential. We are looking for novel things, substantial innovation and unique applications with transformational results. For instance, a project to find out a marker that can tell which TB drug can proceed with development and which should be exited. We are going to look at new scientific hypothesis, new materials and new technologies. How is BIPP different from SBIRI? SBIRI is in its early stage. The projects require small initial resource. In BIPP, projects that succeed in SBIRI could apply and also those which don't fit into the budget of SBIRI. BIPP covers the whole value chain from early stage to late development right through to commercialization. It will look at those projects that require larger resources and demand more in terms of originality, novelty and potential value. SBIRI encourages a wide variety of people to try out a number of things. BIPP is focusing on grand challenges. We want Indian Biotech industry to experience things they would not normally do. However, we are also pragmatic in our approach and we will also support those ideas that do not succeed beyond a certain point. For instance, every vaccine nowadays, stops at Phase I or Phase II, because no one has money to go beyond that, so we are creating our fund to facilitate that. Many SMEs who have NCEs or new vaccines won't go ahead with international partnerships because the risk is too much, so we will partner with them all the way if we see that they have the capacity. SBIRI is our early stage support scheme, BIPP, would concentrate on big science, big innovations, where governments job would reduce/cover their risk. Will BIPP aim at fulfilling a social purpose while generating IP and promoting R&D? We have also combined a social purpose. There has to be a way of thinking about India based solutions that can make a difference. We are going to heavily use our experience and information and knowledge by talking to multiple stakeholders to really design solutions for Indian health in a meaningful way. That's what we meant when we mean when we say, "it is not about advanced science and technology, but unique solutions for big national problems". As for IP, when you do this kind of research, you do not get the product immediately, but a patent first. So the outcome of this kind of research is not just producing a product, as we see it; it is also producing novel, high value IP. How about the funding? We are working with our apex committee (in the next one-month) to create SOPs and provide clarity. We are taking some hypothetical case studies, and will be doing a mock drill on a variety of projects that will come to find out how best can we deal with the projects and ideas that come in. We have given the broad guidelines for funding and there will be refined operational guidelines for the scheme on how it spans out in practice within a month's time frame. What are the challenges that you foresee in putting BIRAC in place? Our challenge is that we have to build that capacity (BIRAC) because it does not exist. Deciding when to charge royalty and how much is anther issue. We need to have a fair scheme and have transparency, openness and avoid conflict of interest. Further, we need to support these projects and develop contracts and agreements, build a brand of officers in BIRAC who know how to do innovation management as against funding. We have to find new people and train old people to do this. So corporate management, helping them use research resources and problem solving is a challenge. We want a BIRAC officer to be a partner and a monitor at the same time and yet not be intrusive. We require to build diverse skills for this. We will require people who can support small companies with clinical trials, writing documents, map out resources and consultants in India and abroad, and do the risk evaluation of projects. Since the investment per project will be large, and being high science projects that companies propose, the degree of skill and manpower has to be high since the companies themselves will be working at the edge of their own abilities. The danger is to oversimplify the challenge in handling such systems, both for the industry and for us. We haven't put in a huge amount of money as yet because we are not sure about the demands. We started with Rs 350 crore and with the passage of time we will put more into it if its worth it. Shalini Gupta   ]]> <![CDATA[BIPP: Fuelling Innovation]]> https://biospectrumindia.com/news/95/2385/bipp-fuelling-innovation.html https://biospectrumindia.com/news/95/2385/bipp-fuelling-innovation.html Fri, 05 Dec 2008 14:35:00 +0530 New Page 1 BIPP: Fuelling Innovation The BIPP scheme approved by the cabinet recently proposes to give a fillip to innovation and R&D in biotechnology by promoting partnerships with the industry... It was a year ago when the National Biotech Development strategy envisaged the formation of a Biotechnology Industry Partnership Programme or BIPP, an advanced technology science scheme, where the government would partner with industries for support on cost sharing basis for high-risk discovery and innovation and accelerated technology development especially for futuristic areas. On November 6, 2008, the Cabinet Committee on Economic Affairs (CCEA) gave its approval for BIPP setting aside an amount of Rs 350 crore for the scheme during the 11th Plan thus paving the way for technological development and innovation in Biotechnology. As a principle, BIPP would strictly promote high risk, transformational technology/process development. No incremental development will be supported. On a broad basis, it is directed at path-breaking research in frontier futuristic technology areas having major economic potential and making Indian industry globally competitive and focused on IP creation with ownerships by Indian industry and where relevant, collaborating scientists. To fulfill the biotech strategy objectives of 30 percent of DBT's R&D investment in partnership with industry under BIPP support would be in four major categories. Category-I Partnership with industry for fulfilling major unmet national technology needs in health, agriculture, energy and environment friendly/green manufacturing areas. This is mainly for those areas, which are of high natural and social relevance with no assured market such as: Agriculture-New crops against drought, salinity or major disease and orphan crops of regional interest where private interest is usually low. Rapid development of vaccines, biomarkers drugs, biotherapeutic agents against major infectious diseases that occur as large outbreaks or epidemics (HIV, tuberculosis, malaria, influenza, dengue, etc) and chronic diseases such as diabetes or stroke. The categorization will be based on national disease burden data, emphasizing death and disabling morbidity. Bioenergy sector-Cutting edge technology for second-generation biofuel development like algal biofuel and bioethanol. Biomedical devices and implants- Indian development of currently imported health devices and equipment that are used on a large scale, (imported ones are inaccessible due to cost) and whose use has a life saving impact. Minor use products will not be supported. Translational research can also be supported to translate basic R&D to product development by the industry if it is envisaged that public institutes would be useful partners. Category-II Partnership with industry for increasing global competitiveness of Indian Industry in new and futuristic technology. This would again support process/technology development leading to high value product commercialization specially in futuristic technologies such as nanoscience applications in medicine and agriculture, bio-based energy related advanced biotechnologies, advanced biomaterials, stem cell biology and tissue engineering, system biology and computational biology, genomics, proteomics and metabolomics related technologies for futuristic diagnostics to name a few. Category-III Partnership with industry for evaluation and validation of products of high national importance. This is to promote innovation in the SME's sector by accelerating the commercialization support for their product evaluation and validation, since it requires a heavy investment to meet increasing stringent global requirements to conduct clinical trials for Pharma products and field trials in case of agriculture products. 100 percent grant-in-aid support would be provided for phase-I, II and III clinical trials of biotechnology based research efforts, for limited and large scale field trials in the case of agriculture products provided there is Indian innovation involved in technology development. The grant would not include any capital investment. SME's as defined by SBIRI (an approved Scheme) would be preferred recipients of support. Category-IV Shared major facilities around technology platform as core facilities. Public-Private partnership is justified for establishment of core facilities to advance research in futuristic technologies and science. An appropriate model is management in the private hands, access to private sector at commercial rates and to the SME sector and public sector at preferred rates. This could include large animal and transgenics facilities, genomic technology centers / facilities, protein engineering science centers / facilities and chemical and molecular libraries to name a few. Idea generation It has been proposed that there would be wide ranging consultation to generate ideas for cutting edge technologies of national and social relevance and possible solutions, with senior experts, academia and industry. The industry partnership platform established by DBT in partnership with FICCI will be used as a knowledge circle for idea generation in partnership with industry. A Technical Screening Committee (TSC), which would be area specific, will then work on the concept development based on priority areas identified. This concept would then be advertised or if there is limited capacity in the country, the most appropriate company which meet the required criteria would be asked to submit a proposal, along with an academic partner whenever felt necessary. The specific priority areas identified would be widely published and the proposals are invited. The priority areas could change with the advancing technologies and these would be considered and approved by the apex committee. Evaluation All proposals would be initially screened for fulfillment of eligibility criteria and after which the area specific technical screening committee constituted by Secretary, DBT, would evaluate the eligible projects. The process of evaluation would include peer review, personal discussion and site visit. The proposals recommended by the TSC would then be placed before the apex committee constituted by Secretary, DBT for final recommendation. The apex committee would decide regarding percentage of cost sharing and also requirements of loan if any. Funding, cost sharing, IP and royalties This scheme provides for grant-in-aid by government to biotech industries ranging from 30-50 percent for the R&D component i.e. Category I and II and 100 percent for the product evaluation and validation. The Intellectual Property, technology transfer and licensing arrangements proposed would vary with the model of partnership and cost sharing. The contribution of the government and percentage of royalty would be as per the apex committee recommendations based on the technical committee's evaluation. Some of the points of considerations will be: level of innovation, an advanced technology of great promise, a technology of tremendous value for national security and public health, level of risk and potential commercial value. Sharing of benefits The IP rights belong exclusively to the industry; in case of other public partners the IP sharing would be on mutually agreed terms among the partners with DBT facilitation. Industry has the exclusive right of license for 10 years after commercial release of product. Thereafter, the license becomes non-exclusive. During this period the license will be held exclusively by the industry in India and it can be licensed outside India only for joint venture. A royalty of 3-7 percent of net sales to be obtained by the government by way of royalty for itself or for public institutions, which may be ploughed back into the project or used for maintenance of patents or any other related purposes. The percentage of royalty would be dependant on the risk factor involved in the technology / product development as determined by expert members of the evaluation committee based on their aggregate scoring and also percentage contribution by industry partner. For the support provided by the government for product evaluation and validation, the percentage of royalty would vary from 0.5-1 percent since the product is already developed by the industry. No royalty would be expected for this category from SMEs. During the period that the industry holds exclusively license, the government shall have the right to acquire royalty-free license in India for non-commercial use of the IPR in case of technologies / products of public interest. The government would reserve the right to require the licensor to license the technologies / products to others and require that anyone exclusively licensed to market the innovation in India must manufacture the product in India also. The industry would be free to negotiate with the prospective licensee on mutually agreeable terms and conditions. The government will only facilitate the negotiation if the two parties are not in agreement on any of the terms and conditions. For joint facilities the profits will be shared on a case-by-case basis as decided by the Apex Committee constituted by DBT for the scheme based on proportion of investment. The ownership would depend on share of contribution to the cost with differential fees for public and private sector users. Monitoring and Project management An Expert Monitoring Committee (EMC) constituted by DBT, one for each project, will regularly monitor the projects under BIPP. The monitoring will include detailed personal report presentation and also site visit. Specially constituted Expert Committees comprising two to three technical experts, one financial expert and one DBT officer will conduct the site visits. The BIPP Scheme itself would be reviewed during plan mid-term appraisal for changes if any required. A Programme Management Unit (PMU) will be set up by DBT for management and monitoring of the programme. The PMU will be responsible for management of all physical and financial aspects of the programme. The PMU would arrange idea generation meetings, provide assistance in project formulation, organize meetings of TSC, EMC, AC, organize site visits for each project monitoring, follow up/ interact with industry regarding product commercialization and be responsible for release of funds and all other aspects of project management.     ]]> <![CDATA[BioInvest Conference discusses on investment trends following global meltdown]]> https://biospectrumindia.com/news/95/2502/bioinvest-conference-discusses-on-investment-trends-following-global-meltdown.html https://biospectrumindia.com/news/95/2502/bioinvest-conference-discusses-on-investment-trends-following-global-meltdown.html Fri, 05 Dec 2008 14:16:00 +0530 New Page 1 BioInvest Conference discusses on investment trends following global meltdown The two-day Bioinvest conference 2008 held in Mumbai, captivated the delegates' attention with heated deliberations on topical issues like investment trends of financial institutions following the global meltdown, investment trends for start-ups and the unveiling of DBT's new initiative. It was a convergence of the who's who from the biotechnology and the banking industry at the two-day BioInvest conference organized by the Association of Biotechnology-Led Enterprises (ABLE) with BioSpectrum as the media partner. It brought together stakeholders from all segments of the industry, to deliberate not just on general issues like the opportunities and challenges confronting the biotechnology industry but also topical issues like the global meltdown and its repercussions, US President-Elect Barack Obama's biosimilar plans and policies, the biofuel revolution and the unveiling the Department of Biotechnology's (DBT) latest initiative-the Biotechnology Industry Partnership Programme (BIPP) which could give a major fillip to an industry reeling under a credit crunch. However what raised eyeballs and captivated attention was the discussion on investment trends, financial crunch, and slow down of the industry following the global meltdown. Talking of credit crunch, there were varied opinions amongst experts from financial institutions and analysts tracking the inflow and outflow of monetary funds into the industry. The usual opinion went that the biotechnology industry is a sector majorly dependent on private equity and venture capital funds. Hence the ripple effects of the global meltdown could be observed over a period of three months. Start-up health care and drug technology firms are struggling to attract funding as venture capital and private equity firms shy away from high-risk projects with long gestation periods in the wake of the global economic downturn. Kiran Mazumdar-Shaw of Biocon Ltd said large private sector funding for technology start-ups will remain tight for some time. The global economic downturn and a lack of confidence in riskier projects have led venture capital and private equity firms to shift their focus to established companies to take advantage of their current low valuations. "New funding is going to be tough for start-up companies now, unless the entrepreneurs are ready to either grossly undervalue their companies or ensure easy exit options," said Dr KK Narayanan, president of the Association of Biotechnology Led Enterprises. One entrepreneur at the conference, who has embarked on a bio-active research project for treatment of hypertension, said he could not find a funding partner as many firms either bargained for a discounted valuation or for easy exit options. He didn't want to be identified as he's still negotiating with fund houses. Aditya Kapil, Principal, VenturEast Funds said, "Investors can gain from the low valuations, but only if they are able to identify technologies that can give significantly big returns after taking the high risk and waiting for long." Consultancy firm, PricewaterhouseCoopers in India, who were the knowledge partners for the event also reiterated upon this point. "Innovation in the pharma and biotech space is going to be impacted heavily owing to lack of funding from venture capital and private equity companies," said Sujay Shetty, associate director (pharma and life sciences) at audit and consultancy firm, PWC, India.Private Equity companies are now looking at companies following derisking strategies. Said Jasmin Patel, Managing Director FIL Capital Advisors (India), "Private Equity firms are now looking at investing in medical devices, drug discovery, and diagnostics. Diagnostics for instance has a lot of prospects for potential growth in the future. A lot of innovation is churning up and we are ready to invest in that." Kapil further went to mention that as far as the global meltdown was concerned early stage companies would not be effected because initially they are not much dependent on market dynamics. He further advised, "If companies really need to attract investment funds, they need to have some very good science and promoters should have a good track record." The event also saw announcements of new initiatives. The DBT's latest initiative- the Biotechnology Industry Partnership Programme (BIPP)- could provide a fillip for research, more so in light of industry facing a credit squeeze following the global financial crisis. The Rs 350-crore package will underwrite the risk of research and development of innovating molecules and processes. It will be open to all innovative biotechnology companies, who are looking to do research in agriculture, health, bioenergy and green manufacturing. The industry has welcomed the move, with participants at the BioInvest 2008 forum lauding it as a positive step by the government. "The government broke the mindset of taking risks when it approved process patents. It is now up to them to try and fix the system and encourage people to take risks in research. The idea is to encourage and reward people who do innovative research," said Shrikumar Suryanarayan, director general of the Association of Biotechnology-Led Enterprises (ABLE). The BPII report states that 100 percent grant-in-aid support would be provided for Phase-I, II and III clinical trials of biotechnology-based research efforts and for limited and large-scale field trials in the case of agriculture products provided there is Indian innovation involved in technology development. The grant would not include any capital investment. Small and medium enterprises (SMEs) as defined by the Small Business Innovation Research Initiative (SBIRI) would be preferred recipients of support. "With the current liquidity crisis, the government has to step in and support research. Otherwise there will be no research and five years down the line there will be a dearth of drugs," said an industry member. Another initiative which came to the forefront was The Biotechnology YES (Young Entrepreneurs Scheme). This is an innovative competition developed to raise awareness of the commercialization of bioscience ideas amongst postgraduate/postdoctoral scientists. The programme is organized by the University of Nottingham Institute for Enterprise and Innovation and Biotechnology and Biological Sciences Research Council. Nayantara Som       ]]> <![CDATA[Reditux, an affordable biosimilar monoclonal antibody]]> https://biospectrumindia.com/news/95/8205/reditux-an-affordable-biosimilar-monoclonal-antibody.html https://biospectrumindia.com/news/95/8205/reditux-an-affordable-biosimilar-monoclonal-antibody.html Fri, 05 Dec 2008 13:55:00 +0530 New Page 1 Reditux, an affordable biosimilar monoclonal antibody With a mission to sell the drugs at one-third, one-fifth or one-tenth of the cost it is being sold today, Dr Reddy's Laboratories has stepped up its efforts in biologics. Though the use of antibodies for therapy was demonstrated almost a century ago, the real therapeutic use became possible only after the development of monoclonal antibody. However, rejection of these proteins by the human immune system known as Human Anti Mouse Antibody (HAMA) response remained the biggest challenge. This led to the creation of chimeric antibodies, which are derived from the fusion of the mouse variable region with the human constant region. Rituximab is one such chimeric antibody against the human CD20 antigen and has been developed for the treatment of Non-Hodgkin's Lymphoma (NHL) and rheumatoid arthritis. In 1993, IDEC Pharmaceuticals (now Biogen-Idec) began phase-I clinical trials with Rituximab. It was launched in the US for the treatment of relapsed or refractory, low grade or follicular, B cell NHL in 1997. In March 2001 the Drug Controller General (India) approved Rituximab for marketing in India by Roche Holding. In 2003, Dr Reddy's Laboratories, the Indian pharma major came out with the novel concept of producing the biosimilar version of Rituximab, a version of Roche Holding's cancer therapy, which could allow a greater access to the drug at half the price of the original. US based Genentech and Biogen Idec market the drug as Rituxan in the United States, and Roche sells it in Europe and other markets under the name Mabthera. Comments from patients: Miranda, Mumbai I noticed a lump appearing below my cheek and it was as hard as a stone. I went to a consultant in Leelavati hospital; he analyzed and told me to do a biopsy and it turned out to be non-Hodgkin's Lymphoma. The doctor informed us about this new drug Reditux from Reddy's Laboratories which when used together with regular chemotherapy is very effective. With Reditux given on the first day itself I felt as if I was getting some energy, which I neither understand nor know the source. The next day they started with chemo and told me to go home. And when I came home I found the lump had disappeared. Now that the trauma is over, I feel I am on top of the world. Veerampati Prasad, Kakinada I am 56 years old. I was working as a Licensed Surveyor in the Kakinada Municipality and I was overseeing building plans and estimates. I started feeling severe pain in the ball and socket joint of my right leg. I noticed a change in my gait and wondered why the pain was not going away. I consulted a doctor. The Doctor suggested that we go for a biopsy test for better diagnosis. When the doctor confirmed that it was cancer. After completing the tests at NIMS and based on the suggestion of one of the NIMS doctors to go for Dr. Reddy's Reditux combined with chemotherapy, I have opted for this treatment. After completing six cycles, there was a lot of change and people who have seen me before the treatment wonder how there was such a positive change and how I recovered so fast. Creating a niche The pace of growth in the development and manufacturing of biologics in India has been slow primarily because of the relative lack of maturity in the key capabilities needed for these activities. Several of the older molecules were first introduced into India based on technology transfer from more developed countries or have been imported as finished dosages. However with the more complex molecules like monoclonal antibodies, Dr Reddy's believes that the preferred strategy is to systematically develop the entire spectrum of development and manufacturing capabilities. The complexity of the molecules and the processes means a close integration of all the relevant skills within one organization with direct links between the manufacturing groups and the process, analytical, pre-clinical and clinical development groups. World class facilities and laboratories of Dr Reddy's, the scientific depth of its team, the robustness of the development strategy and the focus on quality issues were some of the key factors that contributed to the successful development of a complex molecule like Reditux. Reditux is the second product from Dr Reddy's Biologics Division, which is developing treatments for cancer and autoimmune diseases. The company has also launched the generic version of Amgen's Neupogen, and named it Grafeel. The company has spent more than $10 million in developing Reditux and within a year of its launch the products has successfully gained 30-35 percent share of the market. Dr Reddy's Reditux is priced at Rs 39,996 for a vial and is almost half the price of Roche's Mabthera. This product is now approved for marketing in India. Product availability is planned at company's C&F agents and at all major hospitals in the country. The company's marketing niche is to re-engineer biologic therapies and produce them at a cheaper price. There are several other products in development primarily in the areas of oncology and autoimmune diseases. "Within a year of its launch, the number of patients taking Reditux has increased by 2.5 times. This within itself is a good achievement. But that is still less than 5 percent who actually need the treatment," said, Dinkar Sindhu, director, business development, Dr Reddy's Laboratories. Earlier the drug was being sold at approx. Rs 1 lakh per vial of 500mg. However Dr Reddy's launched 500mg at exactly at Rs 39,996, so it is 40 percent of the original price. A patient has to take 6-8 vials during the course of treatment plus there are other costs associated. It would have cost Rs 8-9 lakh including all charges without the generic version. Now it has come down to Rs 4-5 lakh. Since the launch of the biosimilar, Roche has officially brought down their MRP to Rs 80,000 and have been promoting it heavily with the best schemes thus reducing the effective price difference between the original product Mabthera and the biosimilar Reditux. Commenting on the safety aspect of Reditux Dr Cartikeya Reddy, senior vice president and head, biologics, Dr Reddy's Laboratories, said, "The market as well as the number of people treated has grown significantly thus showing the efficacy and safety of the product. We are sure that we are in the right trajectory and I certainly feel that the Indian regulatory system is pragmatic and thus helping the companies to bring such products to the market. However, this requires a certain diligence both from the company and the regulator." Sparsh, a noble initiative In May 2006, Dr Reddy's launched an initiative called Sparsh, meant to reach out to economically challenged cancer patients. This program operates by routing expensive cancer medicines to needy patients through their Sparsh patrons-oncologists across the country. Today, under the aegis of Sparsh, all oncology brands of Dr Reddy's are being given free to patients suffering from cancer. The company has made available medicines worth approximately Rs 6.2 crore as part of the Sparsh program to deserving patients in the year 2007-08, offering 3,000 cycles of treatment using most of the major brands of Dr Reddy's oncology. The program continues to improve the accessibility to oncology drugs to patients in need. Over the past year, Sparsh has provided quality and affordable anti-cancer drugs to over 500 patients, through their doctors. Of this number, 200 patients suffering from Non-Hodgkin's Lymphoma benefited from the new drug Reditux. Sparsh can be accessed on http://www.drreddys-chaitanya.com/sparsh/login.asp by the country's oncologists. Doctors are given access to the website by the company wherein they refer needy patients for treatment of Reditux. Dr Reddy's thus ensures that the patients identified by the doctors through Sparsh are provided the recommended therapy free of cost. Rituximab, since its launch in 1997 as the first monoclonal antibody approved for cancer therapy, has been at the forefront of MAb therapies that have dramatically altered the therapeutic landscape. The company hopes that Reditux will be the first in a series of biosimilar products that will revolutionize the affordability of these products to patients in India. "As an organization, over the past few years we have focused all our efforts on affordability and we hope that some of this will be evident in our subsequent products," said Dr Cartikeya Reddy. "Our mission is to sell drugs at one-third the price of what is being sold today" New Page 2 "Our mission is to sell drugs at one-third the price of what is being sold today" -Dr Cartikeya Reddy, senior vice president and head, biologics, Dr. Reddy's Laboratories Who conceived the idea of working with this molecule? Who all formed the team? It is not in a sense a novel idea and a specific entrepreneurial intent as much as a systematic follow-through on very simple decision that the company made that this is a class of molecule, which should be seriously pursued. However, it was very much an entrepreneurial kind of a dynamic within a larger company. At one level it is not discovery but development. So it is not a scientist's idea, it's just a group of peple doing something where the target is already clear. It was not a contribution made by one person. It was headed by Abhijit Mukherjee (president, pharma services and active ingredients) when I joined. I was in a way handling the operation part but he was more into strategy and planning. Subsequently it moved to executive vice chairman and CEO, GV Prasad. So it is hard to draw a clean line about the effort. In the early phase of 2003, Raghu Cidambi, advisor, legal and strategy played a big role in developing this idea. What are some of the challenges that you faced during the process? The only challenge was to assemble the skills. Apart from that fundamental challenge, I don't think there were any other specific challenges that were so important to us. The key challenge for anybody in this stream is to bring together a team, assembling the skills and essentially being able to do something that very few companies in the world have the opportunity to do, especially in an environment that is very nascent and growing. Will you be marketing this product in other regions as well? Yes, certainly but it all relates to the patent situation in those countries. So wherever there is no patent we are certainly keen. We have launched it in India and we will be looking at launching it in the regulated markets as well. What is the price variation? The treatment cost for a patient using Mabthera would be around Rs 8 lakh. Reditux is a very important drug, which gives significant freedom from the burden of the disease at a price almost 40 percent of the original cost. Dr. Reddy's is a leader in this space as there is no generic antibody anywhere. We are increasing the access to the drug. We are working with a class of molecules that have the ability to create a huge impact. We want to make sure that people at least in the middle class are able to afford the treatment for the disease. With pharma drugs, a person can afford the drugs but worries about the doctor's and hospitalization fees. That success does not translate to biotechnology. The number of patients getting treated by Reditux has increased by two-and-half times. We expect this to double in the coming year. What is your production capacity? We commissioned an entire new area for the production of Reditux. Today we are operating at 200 liter scale which is enough for a market like India. But now that has to be increased. We will be investing $30 million in the next phase of infrastructure building. Are there any other molecules in the pipeline? We have eight molecules in various stages of development. They are all different class of molecules. Some are simple and some are very complicated like Reditux and some are even more complicated. in a oncology portfolio we have two biologics products-Reditux and Grafeel. Otherwise, in total we have 14 anticancer drugs, which are not biotech products. Dr. Reddy's is the second largest player in oncology in India after Roche. Again, our biotech products are not only focused on oncology and monoclonal antibodies but also in nephrology and autoimmune diseases. Jahanara Parveen ]]> <![CDATA[Macro Chip revolution]]> https://biospectrumindia.com/news/95/2873/macro-chip-revolution.html https://biospectrumindia.com/news/95/2873/macro-chip-revolution.html Fri, 05 Dec 2008 13:49:00 +0530 New Page 1 Macro Chip revolution XCyto Screen range of products, which is based on molecular diagnosis, has redefined the scope of diagnostics by facilitating simultaneous investigation for multiple infections. It flaunts inimitable quality with futuristic DNA macro-chip technology. XCyto Screen range of products includes specific and sensitive diagnostic kits that would help to detect over 15 microorganisms responsible for the infection to both eyes and brain. XCyton Diagnostics, the Bangalore-based molecular diagnostics company, launched its XCyto Screen range of products in September 2007. The core concept of these innovative diagnostic products is based on nucleic acid amplification and macro-chip. XCyto Screen DNA Macro Chip There are seven specialized diagnostic kits included under XCyto Screen. Among them XCyto Screen Keratoconjunctivitis, XCyto Screen Endophthalmitis, XCyto Screen Uveitis and XCyto Screen Retinitis are DNA macro-chips for the detection of infections to the eye, which are developed in collaboration with Sankara Nethralaya, Chennai; LV Prasad Eye Institute, Hyderabad; Center for Cellular & Molecular Biology; Hyderabad and AIIMS, New Delhi, NMITLI of CSIR funded the project. XCyto Screen Meningitis is the DNA macro-chip used for diagnosing meningitis in children and is being tested at NIMHANS, Bangalore. While, XCyto Screen Encephalitis is the DNA macro-chip for diagnosing the causative agent encephalitis and is being evaluated at NIMHANS. Funded by DBT, XCyton has also launched the XCyto Screen HPV kit, a DNA macro-chip for genotyping human papilloma viruses, considered as the main cause of cervical cancer. Inexpensive and innovative technique While commenting on the uniqueness of XCyto Screen, Dr Ravi Kumar, MD, XCyton Diagnostics, said, "Identifying the particular microorganism that is responsible for the infections in patients' remains the greatest challenge. Patients are subjected to series of costly diagnostic procedures to identify the exact reason for the infection as further treatment will be decided on the outcome of the diagnosis. Sometime the delay in identification would lead to dysfunction of the affected organ or in others it might even lead to the death of the person." "XCyto Screen range of products, which is based on DNA amplification and macro-chip technology, is an attempt to make the diagnostic process simpler for the doctors and effective and economical for the patients as it allows simultaneous investigation for multiple infections instead of sequentially looking for one infection after the other. This will dramatically lower the cost of the diagnostic protocol," pointed out Dr Ravi Kumar. XCyton Diagnostics is using the XCyto Screen range of products as service packages and many of the prominent hospitals in Bangalore and Hyderabad are making use of XCyton's service and they are satisfied with the accurate result they get from this novel diagnostic technique. XCyton also plans to market the product aggressively in the coming years by setting up diagnostic labs in collaboration with the major hospitals; XCyton is also planning to reach out to the overseas market. The young and energetic team of researchers at XCyton Diagnostics is improvising the DNA macro-chip to convert it as an automated one that can be fixed in the laboratory and can be operated without the help of a technical expert. The new kit will be called as Lab-on-a-Chip and will bring diagnostic to the bed side. The other ongoing projects at XCyton Diagnostics include a chip for detecting Multi Drug Resistant Tuberculosis, being developed based on the work carried out at Earth Institute, Columbia University, Manhattan. XCyton is also developing a series of other DNA macro-chips for the simultaneous detection of various microbes- viruses, bacteria, fungi and parasites that cause acute encephalitic syndrome, septicimia, detection of antibiotic resistance marker and fever. How a DNA macro-chip works? XCyto Screen DNA Macro Chip that is currently used in the diagnosis of eye infection, meningitis and meningoencephalitis, detects the presence of the nucleic acid of the causative organism, which are very few in number. The specimen collected from the patient is processed to extract the nucleic acid. To identify the causative agent the signature genes of the causative agents are amplified. The amplification is done in such a way that all the ingredients required to amplify the signature genes of all the probable causative agents are provided in a single tube. At the end of amplification the task is to identify which causative agent's gene actually got amplified among the probable. This identification is done using the DNA macro-chip. 12 â€“ 50 of short, synthetic, signature sequences of the signature gene are embedded on the surface of the chip. The amplified product is denatured and allowed to renature on the chip. Further by enzymatic reaction a colored spot develops. The orientation of the spots will let one identify which organism signature gene got amplified and thus can arrive at the cause of the infection. The sensitivity of the test is high due the amplification of the signature gene and the specificity of the test comes from the DNA macro-chip where the amplified signature gene is chemically identified by its complimentary sequence. "XCyto Screen is our breakthrough product" New Page 2 "XCyto Screen is our breakthrough product" -Dr Ravi Kumar, MD, XCyton Diagnostics What prompted you to develop XCyto Screen? How did you come up with the idea? We wanted to redefine our path in the year 2003 from immunodiagnostics to something different. The cost of the diagnostic kits for public health has fallen miserably as the government promoted import of diagnostic kits. The number of players has also increased that brought down our business. We shifted our focus to molecular diagnostics for critical illness, where most of the diagnostic companies shy away. How did XCyton succeeded in developing DNA macro-chip-based diagnostic kits? In 2005, we received financial assistance from NMITLI of CSIR to develop Vision Chip. We collaborated with Sankara Nethralaya, Chennai; LV Prasad Eye Institute, Hyderabad; Center for Cellular & Molecular Biology; Hyderabad and AIIMS, New Delhi. That was the beginning of the whole journey of DNA macro-chip. The work on Vision Chip helped us to address all the scientific and technical issues. What are the unique features of XCyto Screen? There are 14 different infections that affect the eyes. In normal diagnosis four to five tests are conducted using the eye fluid to trace out the exact microbes responsible for the infection. Our vision chip allows simultaneous tests for detecting all the microbes and is ridiculously simple. In a disease-based approach one has to undergo several tests. We are following syndrome-based approach that saves time and thereby saves lives of patients suffering from critical illness. XCyto Screen ensures sensitivity and specificity as the DNA macro-chip can check for the exact DNA amplification. There are seven specialized DNA macro-chips included under XCyto Screen for diagnose of keratoconjunctivitis, endophthalmitis, uveitis, retinitis, meningitis, encephalitis and human papilloma viruses. What were the challenges that XCyton faced while developing XCyto Screen? Replacing fluorescence with color for labeling strands, prior to their mutation and maintaining maximum accuracy in DNA amplification were the main challenges. We solved that problem within the four walls of XCyton Diagnostics. We had to make something unique, which could uniformly amplify the genes, without making a bias. Some genes were easy to amplify while some other were difficult to amplify. To tackle that, we used enormous amount of computing and bioinformatics. I consider XCyto Screen as our major breakthrough product. All the credit goes to our dedicated team of researchers. How are you promoting XCyto Screen range of products? XCyto Screen is now used for providing diagnostic services. Our market base is in Bangalore and we will extend that to some other cities also. We are in the process of discussion with many hospitals in all major cities. We can operate from Bangalore for those hospitals that can send us samples within 12 hours. In places where it is difficult to shift the samples we want to put up labs. Our market is very specialized. Earlier we were addressing all hospitals, now we know where to target. It took a lot of time for us to realize the market trend. What are the other major projects in the pipeline? To take the product to the market we need a huge marketing infrastructure. We have finished experimentation and are ready to market XCyto Screen across the country. In 2006, we got investment from Nadathur Holdings and Investments Pvt Ltd, the investment firm established by N S Raghavan, founder and former joint managing director of Infosys. XCyton will start operations in Vietnam and Gulf in the coming year. XCyton is currently developing a series of other DNA chips for the simultaneous detection of various microbes that cause brain infections, septicemia and fever. XCyto Screen diagnostic kits will be automated to convert it into simple tabletop equipment. J Pradeep Kumar   ]]> <![CDATA[An incredible networker]]> https://biospectrumindia.com/news/95/5556/an-incredible-networker.html https://biospectrumindia.com/news/95/5556/an-incredible-networker.html Fri, 05 Dec 2008 12:12:00 +0530 New Page 1 An incredible networker For someone, who is not from a life sciences background, and who is very young, starting a biotech enterprise is not a small challenge. It's even more daunting, if you are a woman. But Anuradha Acharya, cofounder and CEO, Ocimum Biosolutions, circumvented all these odds to build an organization that is strong and growing rapidly. Hyderabad-based Ocimum Biosolutions, which was founded by three young professionals-Anuradha Acharya (CEO), Dr P Sujata (CSO), and Subash Lingareddy (CFO)-in 2000, has blossomed into a global enterprise in a short span of eight years. All this has been achieved because of the ebullient energy of its cofounder and CEO Anuradha Acharya and her transformational leadership. She has successfully grown Ocimum from a company with four programmers to three hundred today and has made three international acquisitions. The company is also moving to a newly built five-acre campus within Hyderabad in another eight months. The company has also bagged the Fastest Growing Life Sciences Company in India, Red Herring Asia 100 Award and IT innovation award by NASSCOM. It has also been on the Deloitte list of fastest growing companies in Asia for three years in a row. As a first-generation entrepreneur, she has also been on the list of "25 tech titans under 35" of Red Herring in 2006. Rapid growth has come on account of managing new challenges on the business, operational and technological fronts and Anuradha Acharya treaded the path bravely. As a result of this, Ocimum transitioned itself from being a training institute to a products company selling high-value products, and now offers a host of genomic services for the pharmaceutical and biotech companies. The beginning A graduate in technology, with a Master of Science in physics, and a wide range of degrees to her credit, Anuradha Acharya represents the young face of Indian biotech industry. Acharya was born in a Marwari family in Bikaner, Rajasthan. She did her schooling in Kharagpur and graduated from IIT Kharagpur. She then moved to Chicago and did an MS in physics and in information systems. While she was pursuing her MS she joined companies like Mantiss Information and SEI Information Technology in Chicago to learn the tricks of running an organization. During that time she looked at several ideas, but none of them were in the biotech space. Many of them were in the internet space, true IT and in finance. In 1999, Anuradha and Subash Lingareddy, a batch-mate turned husband and then a cofounder, along with Dr Sujata thought of starting a biotech company, raising funds from the families. "The idea was we would look at medicinal plants and sequence them. Our original business plan was to have some IP and do some services to generate revenue," said Anuradha. In 2000, she decided to move to India and start the backend support and develop bioinformatics products. "But the going was tough as there were very few people with a background in life sciences and IT in India. Though we had received some 200 resumes, we struggled to find someone who could create a product that is good," she recalled. We could get some people from the US. Thanks to the downturn in economy then that helped us get some really good talent," she added. Anuradha was constantly looking for right talent and thus came up with the idea of focusing on human resource development. This led to the formation of the training division where she trained people in IT and life sciences. "So the revenue challenges were met through the training. We were also looking at products at that time. Our products had a lot of traction but our lab in the US took a little longer to build up. However, here in India, it was becoming more focused in terms of what we really wanted to do," she shared. Commenting on her first acquisition, she said, "In early 2005 our lab got functional in the US, and we started looking at much bigger product sales and bigger partnerships. That was the time when the MWG acquisition happened. We were trying to sell them a bunch of things. And all of a sudden we ended up acquiring a part of that company. We learnt a few things from that deal like making sure that the company that you are building is sustainable and profitable." MWG was Ocimum's first acquisition and that happened without any external funding. The company managed to move some of the infrastructure to India that created a lot of business opportunity here. Though Ocimum had not raised any venture capital till then for acquisitions, this did not stop Anuradha from scouting for companies bigger than hers to acquire. Ocimum has completed three international acquisitions, Gene Logic Genomics from Maryland, USA in the year 2007, Isogen Life Sciences from The Netherlands in 2006 and the GD business of MWG Biotech of Germany in 2005. The company got the first round of funding from the International Finance Corporation (IFC), the private equity arm of the World Bank, in 2006 and acquired the biomolecules synthesis business of Isogen Life Science based in the Netherlands. Ocimum has now raised capital from Kubera Cross Border Fund (KUBC) for an equity investment of up to $17 million (including the pro rata investment by affiliates of Kubera Partners, LLC, the investment manager of KUBC). Ocimum today has 2,000 customers worldwide and operates under three main business units of BioIT, BioMolecules and Bioresearch and has positioned itself as a global genomics outsourcing partner for discovery, development and diagnostics. It now operates out of four strategic locations worldwide, Gaithersburg and Indianapolis in the United States, Ijsselstien in the Netherlands and Hyderabad in India Entrepreneurial streak Commenting on her entrepreneurial venture Anuradha said, "I always had an entrepreneurial streak. I was the only one in my family who was very much interested in selling and making money and doing things that I was not good at. My father used to pay us for small household works and I used to do a lot of them to earn more money, from painting chairs to ironing clothes. I would sit up all night ironing clothes and would negotiate with him. I would even sell the paintings made by my younger sister (a professional painter now) to earn an extra rupee. Those were some of my early entrepreneurial ventures." Anuradha considers her husband as her biggest source of confidence and support. She opined, "I know I have someone who is always there. I am getting all the support not just from a husband but also from a friend and a partner. Since he is my friend first, running the company together has been simpler. Whether it is personal or professional we know we have each other's support all the time. We don't have defined roles and we interchange as and when required. That has always been the advantage for me." Anuradha dreams of making Ocimum a $100 million company by 2010. Her journey to building the company was never easy but she has kept going. Apart from being a successful entrepreneur, Anuradha is also the proud mother of two daughters Neha who is eight-and-half years old and Akhila who is two years old. According to her, it is always challenging to balance the business and the family. "I like spending a lot of time with my kids but I don't. However, I try to spend maximum time with them and either Subash or I are always there. We are both traveling every month but not together, we make sure someone is there with the kids. We also make sure that we attend all their school functions and other events," Anuradha pointed out. "My first goal is obviously to make Ocimum a $100 million company" New Page 2 "My first goal is obviously to make Ocimum a $100 million company" -Anuradha Acharya, CEO, Ocimum How did you come up with the idea of setting up a company? I graduated from IIT Kharagpur and went to the US to do MS in physics and then in information systems. Subash, cofounder of Ocimum and my husband now, who was my classmate at IIT, also went to the US to do an MBA. I was working with few start-up companies there (none of them in the biotech space) and we looked at several business ideas. We saw an opportunity in the bioinformatics space and so registered the company in the US and returned to India in 2000. We took up this office and started building products in the bioinformatics space. Who were your initial partners? One initial partner was the Michigan Tech, the academic partner and then we moved to Alabama to find some partners. We also had some companies who believed in us like Dow Agro and JK Agrigenetics. A lot of agribiotech companies agreed to work with us at the beginning. And soon Ocimum was getting much more acceptable among the major biotechs. Was funding a major challenge in the initial years? We did not focus on funding during our initial days as fund raising is a process in itself and takes away a lot of time. I was just twenty plus years old at that time, did not have a biology background, and generally people do not take you seriously unless you have worked for 20 years. If you are confident about what you are doing, getting funds becomes easy. How have things changed after the acquisitions? We are now seen as a bigger company and a partner for the pharma and biotech companies. We have become more global as we have companies that are more well established in the US and Europe. We have a good foothold on the customer base and pharma and biotech companies see more value in what we are doing now than earlier. Now if a company is looking at genomics they think of us. Is your focus more on services now? We were doing services before but doing it in a very small way. We were doing hybridization services on Ocichip platform. After the acquisition of Gene Logic, we took some very critical decisions. We decided to have the labs in the US, Europe, and India. Ocimum now has the same GLP complaint labs in all parts of the world. We also decided to be technology agnostic. We are an Affymetrix partner, an Agilent partner and an ABI partner and now Illumina. We now have five platforms and thus can give our customers unbiased opinion on that. What would be your message to the next generation woman entrepreneurs? It is not always the glamour that is seen. It requires extreme hard work and confidence and the right attitude. You have to devote 24 hours a day. The first few years are always very difficult, things starts getting simpler as you cross that phase. Where do you see Ocimum five years down the line? First goal is obviously to make it $100 million and after that to look at ways to create a much larger company. Jahanara Parveen   ]]> <![CDATA[Leading Indian science onto the world map]]> https://biospectrumindia.com/news/95/2375/leading-indian-science-onto-the-world-map.html https://biospectrumindia.com/news/95/2375/leading-indian-science-onto-the-world-map.html Fri, 05 Dec 2008 12:04:00 +0530 New Page 1 Leading Indian science onto the world map He is passionate about Indian science and its future and is poised to take India onto the global map with his efforts such as the Open Source Drug Discovery project and the Indian Genome Variation Consortium. "I do not know what I may appear to the world; but to myself I seem to have been only like a boy playing on the seashore, and diverting myself in now and then finding of a smoother pebble or a prettier shell than ordinary, whilst the great ocean of truth lay all undiscovered before me." -Sir Isaac Newton (1642-1727), English physicist I was reminded of the lines above looking at the unbundled enthusiasm and almost infectious child like curiosity of my interviewee, Prof. Samir Brahmachari, the Director General of CSIR (Council of Scientific and Industrial Research). Greatly influenced by, well another scientist, noted American Physicist, Richard Feynman, and his book titled "What do you care what other people think", he said the book helped him see what it takes to be a scientist. With such a bent of mind towards science, I should have expected the probable, when I asked him what would he have been had he not been a scientist. Well, he would have been one either ways. As a student, he always found science fascinating and was academically inclined at school. He confessed, " I was a voracious reader and read too many books. When people read notes, I preferred to read books, so much so that people read a chapter on a subject and I would go ahead and read a book on that." No wonder then that he got the NSTS scholarship in school at the age of 16, that further propelled him to take up Chemistry (Hons) from St. Xavier's College, University of Calcutta, despite the fact that he was good at cracking numbers. What was mathematics' loss was biology's gain, though he might not agree with the statement, the proponent of integrative biology that he is. He believes that it's a synergy of the sciences that can bring about breakthrough research in the dynamic environment that exists today. Prof. Brahmachari went on to do an MSc in Physical Chemistry from Calcuttta University, but it was not where he intended to pursue further research or rather fate had different things in mind. IIScâ€“"A place where I grew up" Getting admission into the Indian Institute of Science those days and even today is something that every scientist worth his salt aspires for, and Prof. Brahmachari was not an exception. "I was keen to get into the Indian Institute of Science, Bangalore. The lush sprawling campus of the institute was like a breath of fresh air from the crowded streets of Kolkatta." But he had a lurking fear-the fact that he had a shortfall of 0.3 percent from first class to do a PhD at IISc. "I recall August 7,1974, when I was wondering whether or not I could pursue my research, standing there all day for the interview. I gave the interview, after which not only did the registrars agree to my admission but so did CSIR, so I am still clueless as to who was this unknown officer who made a dream of mine come true by letting me be a part of a prestigious institute like Indian Institute of Science, from where I have learned a lot. I realize today, sitting here as the director general of CSIR, how tough it would have been for that officer at CSIR who had the courage to overlook the 0.3 percent shortfall." Life's lessons "I had exceptional teachers. What I learnt at Indian Institute of Science was that, knowledge is more important than learning just for marks and that the objective of research is not to do studies, but to solve a puzzle or a problem. I also realized that great institutions are great because they have an inherent ability not to lose sight of their larger objectives and also the flexibility to overcome bureaucracy. Then I was extraordinarily lucky that I was with Prof. GN Ramachandran and other galaxy of scientists who actually demonstrated that sitting in this country one can have their own niche and can be globally recognized. I imbibed the confidence that an Indian scientist doing research in India can do it globally. I feel fortunate to have these teachers who guided my path and I owe my success to these great mentors who shaped my potential." Perhaps this was the best shortfall that anyone could have ever had to raise to the highest rank of a scientific office in the country. Prof. Brahmachari went on to do his PhD in Molecular Biophysics from IISc. IISc as he said was populated with budding young talent, wonderful teachers and legendary figures, so much so that he recounts that one of his teachers Dr Balaram was only a few years older to them that time, a man with enchanting oratory skills as he puts it. IISc gave this tall, lanky, hesitant Bengali boy, the confidence to be in his skin and aspire for higher skies. It was a tremendous demand of professionalism from Dr G N Ramachandran (his assignments) and the rigor of it that instilled a scientific temper in him. Thus began an unending tryst to solve puzzles in science and celebrate science. "I never bothered what paper will I write or where, I just wanted to solve a problem." A man of action An avid reader of Rabindranth Tagore's poems, which he considers as a source of inspiration to him, Prof. Brahmachari has always been driven by action led research. Proof lies in the fact that he has over 134 publications in leading international journals and 10 patents and 14 software copyrights to his credit. He has guided 17 PhD scholars and over a hundred research students, postdoctoral fellows and project associates. He is also the elected fellow of all the three National academies of Sciences in India and the recipient of several National and International awards. After completing his PhD, and a short postdoctoral stint in France, he joined IISc's Molecular BioPhysics unit as a research associate in 1979. He underlines the role that his teachers have played in shaping who he is today. "I was very fortunate that I was given a place across the office of Dr G N Ramachandran, a legendary figure and I read all his books and papers. I had the privilege of being taught by people like Dr Ashima Chatterjee, Prof. Mihir Choudhary and Prof. Sadhan Basu in Kolkatta and I exchanged my notes with my friend in IIT Kanpur, where Prof. CNR Rao and Prof. D Balasubramaniam were teaching. I count myself to be fortunate to have got an opportunity to study under such extraordinary teachers." He went on to become a Professor of Molecular Biophysics Unit and Genetic Engineering at IISc, a role that he fulfilled till 1997. During his tenure at IISc, he demonstrated the structural flexibility of DNA and the role of repetitive sequences in DNA transactions much before the repeats association with genetic markers. His work on the structural flexibility of telomeric repeat sequences is one of his well-cited contributions. Prof. Brahmachari then served as the director, IGIB, Delhi for the next 10 years (1997-2007). He was the first to establish a close clinical network to address genetics of complex disorders and demonstrated association of two genes with schizophrenia and bipolar disorder and identified several SNPs and other markers associated with various neurological disorders. "Its not worth doing science if you are not asking difficult questions, hence my selection of working on repetitive DNA was when no one believed that it would have any function. I think it is important in science to look for a niche which others haven't thought about," he commented. "When Prof. Samir Brahmachari was given the position of director general (DG), CSIR (after a completely unwarranted delay in the process) my immediate reaction was `Samir will be ten times better as a DG in comparison to me! I have said this publicly again and again. Samir combines a rare blend of brilliance, creativity and enterprise. When I was DG, CSIR, I witnessed each of these attributes time and again - and indeed, CSIR and I benefited from these. As the director of the Centre for Biochemical Technology (CBT), he transformed CBT to Institute of Genomics and Integrative Biology (IGIB), created The Centre for Genomic Application (TCGA) as a unique public private partnership, took CBT to new heights in term of world class science, forged powerful international partnerships and in general did CSIR proud." -Dr R A Mashelkar, former DG, CSIR, and winner of BioSpectrum Life Time Achievement Award in 2006 Genomics: His Passion "When others were learning to use what they knew, I was learning to differentiate what I knew," said Prof. Brahmachari. And this differentiation has certainly led him to be an authority in the area of functional genomics with special emphasis on molecular genetics of neurological and psychiatric disorders and functional genomics in silico. Prof. Brahmachari recognized very early the importance of genomics in the world and organized a genome analysis workshop with American molecular geneticist, Charles Cantor in 1987 at IISc, he recalled. He was one of the earliest members of the Human Genome Organization, which was formed in 1988. India was nowhere on the genomic map then. And today 20 years down the line, when he is at the helm of decision making at CSIR, he has left no stone unturned to place India on the world genomic map. 2008 saw, Human Genome Organization (HUGO) hold its 13th Human Genome Meeting in Hyderabad as it turned 20 years old, thus recognizing the importance of India and its scientific capabilities in genomics. The event saw a galaxy of scientists from India and abroad delivers lectures, workshops and symposia on various aspects of genomics. Not only this, CSIR, also launched the Open Source Drug Discovery programme in global partnership to combat the scourge of infectious diseases that afflict the developing world. Tuberculosis (TB) will be the first disease target for the project that has been allotted a sum of 500 crore and aims to provide a platform for collaborative research thus targeting affordable health. And last but not the least, Prof. Brahmachari leads the Indian Genome Variation Consortium, which has developed a database of over 1,000 genes related to disease and drug response, exploring human genome variation in multi-ethnic, multi-lingual populations of India to develop a national resource: the genetic profile of the people of India. "The objective was to create a basal data for disease profile and not to map genetic diversity. This is the first time anywhere in the world that a single country has been mapped to this extent," added Prof. Brahmachari. Put simply, it would help us know which populations stand the risk of a particular disease, thus help us not only predict the diseases as well as the effectiveness of drugs for these diseases thus making the management of that disease much easier. With such developments behind us, the future sure sounds exciting for Indian science. "21st century is the century of biology in an integrated fashion" New Page 2 "21st century is the century of biology in an integrated fashion" -Prof. Samir K Brahmachari, Director General, CSIR You are cited as a proponent of integrated biology. Your comments? Today if one looks at integrated biology and genomics, these are all nothing but very large bandwidth subjects. They involve the understanding of biology, molecular biology, structural biology, genetics and cell biology. So, I believe that the 21st century is the century of biology in an integrated fashion. Today we are moving into synthetic biology, systems biology, where all disciplines of science get merged. Having a biased attitude towards a particular discipline of science is not what is needed today, but it is something that people develop over a period. I see myself as a free-floating individual who takes whatever is needed to solve a problem, be it blending of scientific disciplines. It is permitted as long as it helps us get answers to scientific problems. How has the role of CSIR changed over the years? CSIR is an organization that is 67 years old and I believe that it has played its role pretty well in all the years of its existence. People who have been here before me have taken it where it is today. CSIR today produces 4,000 papers and trains over 3,000 scientists including 400-500 PhDs. Today we have a portfolio of 3,000 patents, whose utilization is about 6.7 percent, which is comparable to what happens in other parts of the world. Patent realization per patent is very low, because we do a lot of non-exclusive licensing. As the country was a closed economy during the initial years, CSIR's focus was to create industrial competitiveness and make the Indian industry self reliant by manufacturing tractors, agro-products, pesticides, baby food, generic drugs, structural engineering to build bridges, catalysts for petroleum refineries and chemical industries thus providing science and technology (S&T) support for our strategic sector. But now as we are increasingly a part of the globalized economy, CSIR's objective is to create new Intellectual Property Rights (IPR) and inventions. In the last 10 years, CSIR has done incredibly well in high science and intellectual property. Our aim is to take this forward to a new level and at the same time ensure science and technology intervention for the rural development. What were the achievements of CSIR in the last one-year? We had set ourselves a goal of launching a completely new initiative called Open Source Drug Discovery. We believe that the infectious diseases market is low; pharma companies don't invest in it. This is a paradigm shift on the part of the CSIR, where we have moved ahead with the project and have got tremendous response both nationally and internationally. We are focusing on affordable health and sustainable energy. In sustainable energy, we have tried to look at how we can use solar energy operated transport, which led to the launch of a rickshaw on the same principle called-Soleckshaw that was developed within the stipulated time target of nine months. The most satisfying project this year was the Indian genome project. The results that have come out of it have been promising and catapult India onto the global genomics map. What is your vision for CSIR? I want to utilize the machinery of CSIR, for creating a constructive change in science and technology of the nation, building next generation leaders and using S&T for the benefit of the rural poor and also get global respect for Indian science. I think today we need leaders in integrative science that involves the convergence of all disciplines and this is where CSIR has to lead the way. We want to spin off companies and commercialize our IP so that scientists can also be a part of the process. We are also looking at having a CSIR Advanced Institute of Science and Technology university (AIST), like a research university that can create new generation of interdisciplinary scientists and also give degrees in the line of Chinese Academy of sciences. Shalini Gupta   ]]> <![CDATA[BioSpectrum Awards 2008]]> https://biospectrumindia.com/news/95/5920/biospectrum-awards-2008.html https://biospectrumindia.com/news/95/5920/biospectrum-awards-2008.html Fri, 05 Dec 2008 11:24:00 +0530 New Page 1 BioSpectrum Awards 2008 December is the time for the annual BioSpectrum Awards, which were started in 2003. The awards are to recognize the exceptional contributions of the industry to the development of biotech sector in the country. There are two key categories of awards-BioSpectrum Biotech Industry Awards and the BioSpectrum Company of the Year Awards. The jury decides on the BioSpectrum Biotech Industry Awards, which comprises mainly the Person of the Year, Life Time Achievement, Entrepreneur of the Year, Product of the Year, and the special category award. The awards under the Companies of the Year category are decided by BioSpectrum. The winners of this category of awards are chosen on the basis of the "BioSpectrum-ABLE Survey of the Biotech Industry". The top ranked companies (by revenues) in each of the sectors are the winners. The BioSpectrum Biotech Industry Awards were selected by a panel of eminent people, who come from various backgrounds. The panel is empowered to nominate or introduce any special category of award. BioSpectrum Awards 2008 jury and deliberations The process started with the constitution of the panel in the first week of September 2008 and laying down the criteria for the selection of BioSpectrum Awards 2008. This was followed by the members of the jury meeting in Hyderabad on October 1, 2008 for making the final choice. The jury headed by Varaprasad Reddy, chairman, Shantha Biotech and BioSpectrum Person of the Year 2007 comprised of: Prof. Vijay Chandru, chairman, Strand Life Sciences and BioSpectrum Entrepreneur of the Year 2007. Dr Shrikumar Suryanarayan, director general, Association of Biotechnology-Led Enterprises (ABLE), Bangalore. Tapan Ray, director general, Organization of Pharmaceutical Producers of India (OPPI), Mumbai. A Ramesh, general partner, APIDC-Venture East, Hyderabad. Narayanan Suresh, group editor, BioSpectrum. Abraham Mathew, chief editor, BioSpectrum. The jury was unanimous in its choice of selecting the winners in most of the categories. BioSpectrum Life Time Achievement was decided in favor of Prof. G Padmanaban, NASI-Platinum Jubilee Chair, IISc, for his selfless and tireless service to the biotech industry and biotech research in India. The jury chose Prof. Samir K Brahmachari, director general, CSIR as the Person of the Year. Varaprasad Reddy observed, "Prof. Brahmachari's efforts in the open drug discovery program and the Indian Genome Variation Consortium are very promising. He has put Indian research on the global map now." Anuradha Acharya, CEO, Ocimum Biosolutions, was announced as the Entrepreneur of the Year. Under her leadership, Ocimum has made three major acquisitions, increased its global presence, and is emerging as major player in the genomics area. The jury considered the technological efforts involved in the development of the XCyto Screen Macro Chips and also highlighted its quality of fulfilling an important societal need as an affordable medical product, while selecting it as the product of the year along with Reditux. The second product from Dr Reddy's Laboratories' Biologics Division, Reditux is a biosimilar version of Rituximab for cancer therapy. Within a year of its launch, Reditux has garnered 30-35 percent share of the market and brought down the prices to affordable levels. The awardees of 2008 are: BioSpectrum Life Time Achievement Award 2008: Prof. G Padmanaban, emeritus professor, IISc, Bangalore. BioSpectrum Person of the Year: Prof. Samir K Brahmachari, DG, CSIR, New Delhi. BioSpectrum Entrepreneur of 2008: Anuradha Acharya, CEO, Ocimum Biosolutions, Hyderabad. BioProduct of 2008: Reditux from Dr Reddy's Laboratories, Hyderabad. XCyto Screen, the new diagnsotic tool from XCyton Diagnostics. The jury chair, Varaprasad Reddy, guided the entire process of arriving at unanimous decisions and notified each winner of the selection and the winners have agreed to accept the awards. The winners of BioSpectrum Awards 2008 would be honored on December 12, 2008 at a function at The Leela Palace Kempinski Bangalore. Bio-Rad is the principal sponsor for the Awards Nite, while Serum Institute of India and Oxford Institute have come forward to be the associate sponsors. ]]> <![CDATA[Vaccines Alive]]> https://biospectrumindia.com/news/95/1584/vaccines-alive.html https://biospectrumindia.com/news/95/1584/vaccines-alive.html Wed, 05 Nov 2008 16:49:00 +0530 New Page 1 Vaccines Alive India's Rs 2,000 crore vaccine industry can now breathe easy till March 31, 2009. The World Health Organization (WHO) has given India's drug regulator, DCGI, an extension to its October 31, 2008 deadline by five months to upgrade its testing laboratories. The October 31 deadline was hanging like a Damocle's Sword over the vaccine industry who were caught in the cross fire between the Indian regulator and WHO over some quality issues. Vaccine industry leaders had vented their fury at the regulatory set up during a special meeting organized by BioSpectrum in Mumbai on August 28 for threatening their existence. Hopefully, the government will speed up its publicized plans to quickly upgrade the three de-recognized public sector vaccine manufacturing units to international standards. The quality issues plaguing these century-old manufacturing units which were also used by the DCGI for conducting drug tests had come in the way of WHO certification for new India-made vaccines. Another good news is that there has been some more forward movement in the enactment of India's own Bayh-Dole Act which will spur innovation in the country's government-run laboratories and research institutions. The Federal cabinet, on October 31, has approved the draft of the Protection and Utilization of Publicly Funded Intellectual Property Bill, 2008. The legislation can now be introduced in Parliament for its approval. Though this is a good development, there are some misgiving in the industry and scientific committee about some of its provisions. Concerns have been raised about the provision which seeks to provide exclusive marketing rights with royalty for patented products developed in public institutions. With the country's leading industrial research network, CSIR, championing the cause of Open Source Drug Discovery, there is a strong case for only allowing non-exclusive licensing arrangements for products developed with public funding. Science and Technology Minister Kapil Sibal had recently promised to look into some of these concerns raised by experts. It will be in public interest if the draft of the legislation that will go to the Parliament for approval is released for suggestions and comments. The Department of Biotechnology (DBT), under Sibal's watch, has won wide acclaim for its wide-ranging consultations on the new Biotech Policy as well as the proposals for setting up a National Biotechnology Regulatory Authority (NBRA) in the last two years. The DBT's example should be followed in the case of the public R&D Bill too. Prime Minister Manmohan Singh has called industry leaders for consultations to revive the sentiments of the economy, impacted by the bad news coming from the global banking sector. The biotechnology sector was hit by the Rupee appreciation last year and the export-oriented sector can look forward to the depreciating Rupee with some cheer. However, how the recessionary trends in the global markets will have its immediate impact on the industry is not clear. Experts have indicated that due to the essential nature of life sciences, the industry's prospects may not be dented too much. Anyway, the industry has its wish list to the Finance Minister P Chidambaram for his Union Budget 2009. The list is not too long and industry hopes the Finance Minister will continue his biotech-friendly initiatives for one more time. BioSpectrum too is starting two new initiatives in 2009. First, there is a plan to bring out a comprehensive Education and Careers Resource Guide (ECRG) in early 2009 to answer almost all the queries biotech students and future industry professional have about the industry. BioSpectrum is also planning to organize, Navigate 2009, the first Life Sciences Business Convention (February 18-19, Mumbai) to bring together the community on a common platform to address the future challenges and opportunities together. <sureshn@cybermedia.co.in> ]]> <![CDATA[Research Councils UK opened in India]]> https://biospectrumindia.com/news/95/2461/research-councils-uk-opened-in-india.html https://biospectrumindia.com/news/95/2461/research-councils-uk-opened-in-india.html Wed, 05 Nov 2008 13:39:00 +0530 New Page 1 Research Councils UK opened in India With £48 million of investment in research projects in India by Research Councils UK in the past few years, Indian R&D is poised to benefit especially in the area of crop science. It was in January 2008 that the Prime Ministers of India and the UK reiterated their commitment to increase the research collaboration between the UK and India and agreed to open Research Councils UK (RCUK) Office in India. Co-located with the Science and Innovation Network in the British High Commission, New Delhi, the new office was launched in New Delhi recently by Prof. John Beddington, chief scientific advisor for the UK. Also present at the occasion were Lord Kumar Bhattacharyya, director of the Warwick Manufacturing Group, Dr RA Mashelkar, president of the Global Research Alliance, and Professor Alan Thorpe, chief executive of the Natural Environment Research Council. The RCUK office in India will work with Indian funding bodies to share strategies, increase dialogue on funding priorities, and pursue and promote collaborative research opportunities. It is aiming at a funding of £5 million for new research on energy, to be undertaken with Indian partners and focusing on priority areas such as solar energy by next year. Speaking on the occasion Prof. John Beddington, chief scientific advisor, said, "The opening of the RCUK Office in India is yet another demonstration of how the UK is recognizing the value of global collaboration in tackling future challenges. Working with partners in emerging economies is vital to bring about the best possible research outcomes. In this time of economic gloom and doom, it is important that we keep sight of the big picture and work together with global partners to achieve solutions." The seven Research Councils are independent, non-departmental public bodies, funded by the Science and Research Budget through the Department of Innovation, Universities and Skills (DIUS). They are incorporated by Royal Charter and together manage a research budget of around £3.4 billion a year. They are closely working with partners in India and in recent years an estimated £48 million of investment has been committed to research projects involving collaboration with Indian partners. The Biotechnology & Biological Sciences Research Council (BBSRC) on Sustainable Agricultural Research for International Development (SARID) along with the Department of International Development (DFID) is funding 12 projects worth £7.5 million out of which three of the top ranked applications (with a funding of nearly £1.9 million) involve institutions based in India. Indian researchers from The Energy and Resources Institute, University of Delhi, Hamdard University, GP Pant University of Agriculture and Technology, Pantnagar and Krishidhan Seeds Ltd Jalna are working in collaboration with researchers at Rothamsted Research and the John Innes Centre in the UK supported by BBSRC on Brassica genetics to understand oilseed productivity and resistance to fungal disease. They hope this would not only help increase yields and quality by addressing crop traits affecting sustainable oil production for food and non-food use (including bioenergy). The two countries hope to benefit from each others expertise and there is more to come in the next few years. Indian projects funded by SARID Indian university Collaborating University Project being worked upon Funding (£ 000) Calcutta University University of Aberdeen, Bangladesh Agricultural University, The Chinese Academy of Sciences, The International Rice Research Institute, Rothamsted Research Characterizing genetic and soil induced variation in arsenic uptake, translocation and metabolism in rice to mitigate arsenic contamination in Asia 653 ICRISAT, Patancheru University of Sheffield, African Rice center Unraveling molecular genetic basis of Striga resistance in cereals: integrating Quantitative trait loci (QTL) and genomic approaches) 597   ICRISAT and ICAR, Mandor, Jodhpur Institute of Grassland and Environmental Research and the University of Cape Coast, Ghana. Integrating genomics and mapping approaches to improve millet productivity in drought prone regions of Africa and Asia 631     "It's important to realize that we are in very dramatic times," Prof. John Beddington, chief scientific officer, the UK government. What was the need behind setting up of the India office? It's important to realize that we are in very dramatic times. We are facing global issues such as food security, water security, climate change and all these are interrelated. International collaboration is the key to solving these problems. India has an enormously successful program running in the area of food security, right from genomics to animal livestock production and the control of animal disease. With the opening up of the Delhi office we now have thee offices outside the UK including Washington and Beijing. What are some of the key issues of interest (especially in biotech) that the RCUK aims to work in India? We recently attended a two-day India-UK food crop workshop at the Institute of Genomics and Department of Science & Technology (DST) and I see clearly important potential on plant genomics and plant biotechnology to plant diseases, resistance to drugs and saline conditions. We also see a potential in infectious diseases wherein Biotechnology and Biological Sciences Research Council (BBSRC) is working along with the Department of International Development (DFID). How was the response to the BBSRC India partnering awards? The scheme is to provide resources to leading BBSRC-supported research groups to allow them to forge long-term relationships with Indian scientists in areas of research that are of direct relevance to BBSRC's current scientific strategy. The first call for the BBSRC India partnering awards was in 2006 and there was another last year and this year we are accepting proposals till 12 November 2008. An award of up to £25,000 is awarded for a period of four years for partnership with one or more Indian institutes. Since the launch of the scheme in September 2006, 11 partnering awards have been announced with a contribution from BBSRC of £250,000. Shalini Gupta   ]]> <![CDATA[Wellcome Trust allocates Â£30 million to support and fund R&D projects]]> https://biospectrumindia.com/news/95/7229/wellcome-trust-allocates-30-million-to-support-and-fund-rd-projects.html https://biospectrumindia.com/news/95/7229/wellcome-trust-allocates-30-million-to-support-and-fund-rd-projects.html Wed, 05 Nov 2008 13:29:00 +0530 New Page 1 Wellcome Trust allocates £30 million to support and fund R&D projects The Wellcome Trust is an independent charity funding research, based out of the UK. Established in 1936 and with an endowment of around £15 billion, it is the UK's largest non-governmental source of funds for biomedical research. The trust also funds initiatives for technology transfer, universities and other streams of the academia in overseas locations. The trust is now looking at Indian shores where it intends to play an active part in funding R&D initiatives both for institutions and companies. Dr AE (Ted) Bianco, director of technology transfer; Fiona MacLaughlin, senior business analyst, technology transfer; and Dr Shirshendu Mukherjee, strategic advisor, R&D initiative, India, in an exclusive chat with Biospectrum threw light on the salient features of the scheme which will kick start in some time and plans for India. From right to left: Dr Ted Bianco, Director of Technology Transfer, Dr Shirshendu Mukherjee, Strategic Advisor to the programme and primary contact and Dr Fiona MacLaughlin, Senior Business Analyst, led for the programme in London Having achieved a wide reach in the UK, how will Wellcome Trust now make its funding initiatives India specific? Ted: This mission is definitely specific to India and the trust has allocated £30 million for a period of five years to support and fund R&D projects in India around the theme of affordable healthcare. We target top quality products using India' s acumen for business making the product reach more beneficiaries and at reduced costs. That might be because you pitch in for larger volumes and also allow some volumes of generic components but used in imaginative ways and which brings up new remedies. But this will happen only when companies are willing to bear the whole cost of R&D. How different is this funding scheme from any other funding initiatives that we have seen till date? Dr Mukherjee: The beauty of this scheme is that we are open to the industry. Here the industry can directly apply for funds either individually or in collaboration with government institutions, which we normally do not see in any other scheme. By collaboration, I mean that if a product or technology is brought out by an institution but needs the help of the industry, in such a situation, they can both together come to us and apply for funds. If we see that the product that they are coming up with is credible and leads to affordable healthcare we are ready to fund these initiatives. In other schemes, usually it is the case where funds cannot be directly applied and given to the industry. When was the process initiated in India? Ted: The process started three years go and we were in India this February at the invitation of Dr Swati Piramal where we even had an interaction with Kapil Sibal on issues of R&D funding in India. We had the same concerns, thoughts and the conclusion was that India is a great opportunity not just for support but even a great place for R&D work. What would be some of your criteria for funding a company or an institution? Fiona: Generally it will be the company who will be approaching Wellcome and not the other way round. For us it will really be the credibility of the project, the team and the proposal that the company will be submitting. In a company proposal, we will be looking at appropriate assets of the company; how do they intend to drive the program in the right way; and we will also see what the product would look like vis-Ã -vis the technology demand in the market. Then, in terms of science, the technology/product should be excellent and reflect the prevailing market needs for science. Is the trust's funding just targeted towards drug discovery? Ted: Though it is believed that the our funding scheme is targeted towards drug discovery and development but we would also like to support medical devices, software that makes medical insurance better, diagnostics and maybe even vaccine companies. We will also be looking at even joint ventures, not-for-profit and for-profit institutions. We are also offering a fellowship scheme in collaboration with Department of Biotechnology (DBT). We have collaborated with health foundations in India, which do not have good resources. There will be projects in India where we will be collaborating with scientists from other parts of the world because that has always been our tradition--to partner and research with scientists in any part of the world. Like for instance, our fellowship schemes, where we are trying to build people infrastructure, will be a big consideration for budding scientists where they will be rubbing shoulders with some credible names in the world. We found that major institutions in India are not evenly spread but just concentrated in certain pockets. I think that the major challenge in India is to put these Indian scientists from all over in a productive environment and not vice versa. For that you will have to ensure that some credible names come in and join hands with these people. There was also a GSK connection with the Wellcome Foundation. Can you elaborate on that aspect? Fiona: Wellcome Trust became an independent entity when the trustees sold stakes of the Wellcome Foundation sold to GSK. To go back to history, Sir Henry Wellcome created a company, which was called the Wellcome Foundation Ltd, a pharmaceutical company. However when Henry Wellcome died, the Wellcome Foundation was put under the control of board of trustees. All his assets (both commercial and non commercial) were put under the trust of these trustees and that is how the Welcome Trust was formed. In 1985, they made the Welcome Foundation (the pharma company) public and they sold 25 percent of the shares to the public. Nine years later, they sold the rest 75 percent stake to GSK. The trust was no longer affiliated to the pharmaceutical company and became a totally independent organization altogether. Wellcome Trust will also be supporting start-up projects. Will the criteria be the same for these projects too? Fiona: Yes, we will be funding small immature companies here .The criteria is the same for these companies as applicable to others. Wellcome focuses on adhering to appropriate due diligence on all proposals whether it is a small biotech company or a big commercially profitable company. It all depends on the credibility and the excellence of their product. Nayantara Som       ]]> <![CDATA[Gates Foundation invests in 104 novel ideas for global health]]> https://biospectrumindia.com/news/95/1562/gates-foundation-invests-in-104-novel-ideas-for-global-health.html https://biospectrumindia.com/news/95/1562/gates-foundation-invests-in-104-novel-ideas-for-global-health.html Wed, 05 Nov 2008 13:03:00 +0530 New Page 1 Gates Foundation invests in 104 novel ideas for global health Unconventional ideas include a hypothesis on mosquitoes to act as "flying syringes to deliver vaccines" when they bite. The Bill & Melinda Gates Foundation recently announced 104 grants to explore bold and largely unproven ways to improve global health. The grants worth $100,000 each will be made to scientists from 22 countries and five continents. They mark the first round of funding from Grand Challenges Explorations, an initiative to help lower the barriers for testing innovative ideas in global health. In all, 104 grants were selected from nearly 4,000 proposals, with the geographic distribution of applicants largely matching the geographic distribution of awards. The winner of Grand Challenges from India is Karthikeyan Kandavelou, project leader, Pondicherry Biotech Pvt Ltd. His project on a novel approach to prevent or cure HIV Infection will explore genetic approaches to fighting HIV/AIDS, by attempting to mimic the natural resistance to HIV found in some people. The initial set of grants will inject fresh perspective into research for preventing or curing infectious diseases such as HIV/AIDS and TB, and limiting the emergence of drug resistance. Successful applicants showed how their project falls outside current scientific paradigms and could lead to significant advances if successful--in just two pages. The applicant details were not provided to reviewers, helping them to focus on the innovation of the idea instead of a scientist's credentials, geographic location, or organization's reputation. "We were hoping this program would level the playing field so anyone with a transformational idea could more quickly assess its potential for the benefit of global health," said Dr Tachi Yamada, president of global health at the Gates Foundation, who announced the grants at the fourth annual meeting of the Grand Challenges in Global Health initiative in Bangkok. "The quality of the applications exceeded all of our expectations. It was so hard for reviewers to champion just one great idea that we selected almost twice as many projects for funding as we had initially planned," he added. All levels of scientists are represented, including young investigators who have never before received a research grant, and those who were applying experience from other fields like bioengineering. Grants were made to universities and other nonprofit organizations, government agencies, and six private companies. Projects cover a wide range of innovation, including a "mosquito flashlight" to prevent malaria transmission by disrupting wavelengths, self-destructing TB cells, and studying anti-infective properties of the eye to help prevent HIV/AIDS and other infectious disease. Applications for the second round of Grand Challenges Explorations are being accepted through November 2, 2008, and topics for the third round will be announced in early 2009. Grant application instructions, including the list of topic areas in which proposals are currently being accepted, are available at www.gcgh.org/explorations. Some Novel Projects Mimicking effective natural processes to limit infectious disease Pattamaporn Kittayapong at Mahidol University in Thailand will explore new approaches for controlling dengue fever by studying bacteria with natural abilities to limit the disease. Suzanne Fleiszig at the University of California, Berkeley, in the US will focus on the natural defenses of the human eye to discover new classes of broad-spectrum anti-microbial agents. Elizabeth Sockett at the University of Nottingham in the UK will study whether the best medicine against some disease-causing bacteria may be a "living antibiotic" made up of microorganisms that naturally prey on harmful ones. Engineering ways to enhance the natural human immune system Leonard Damelin at the National Health Laboratory Service in South Africa will attempt to improve bacteria that naturally line the walls of the vagina and cervix in order to enhance their ability to fight infections. Yen Wah Tong at the National University of Singapore will attempt to create nanoparticles to "soak up" viruses circulating in the body; the particles will be imprinted with the viruses in order to mimic the three-dimensional structure of cells that the virus normally tries to infect. Jord Stam at Utrecht University in the Netherlands will attempt to create "two-sided" antibodies to fight HIV; one side would attach to HIV, and the other side would safely deposit the virus in cells in which it cannot replicate. Sanah Jowhari at TheraCarb, a biotechnology company in Canada, will apply technology to capture and remove the cholera toxin from the body of a host, and validate an approach to developing an effective drug candidate for cholera. Probing unexpected results for global health Elijah Songok at the Kenya Medical Research Institute will explore whether natural resistance to HIV may be linked to genetic markers for type 2 diabetes. Huan Nguyen at the International Vaccine Institute in Korea will follow up on the unexpected finding that a fluorescent green protein originally intended as a research control could be the basis of a highly effective influenza vaccine. Exploring hypotheses that challenge conventional wisdom Mike McCune at the University of California, San Francisco, in the U.S. suggests that the best immune response to HIV may be no response at all, because the immune cells that are marshaled to fight the virus are the same cells that HIV infects. Hiroyuki Matsuoka at Jichi Medical University in Japan thinks it may be possible to turn mosquitoes that normally transmit disease into "flying syringes," so that when they bite humans they deliver vaccines. A complete list of the funded projects is available at www.gcgh.org/ explorations. "We are excited about the potential of scientists in India and Asia," Andrew Serazin, program officer, Gates Foundation Grand Challenges Explorations is a five-year $100 million initiative to promote innovation in global health. It is part of the Grand Challenges in Global Health initiative, which is supported by the Gates Foundation to achieve major breakthroughs in global health. We find out more in interview with Andrew Serazin, Program Officer, Gates Foundation. What is the objective of the Grand Challenges Explorations? The objective is to increase the number of bold and unconventional ideas that are being investigated for global health. We gamble on a small number of ideas and the greatest problems facing humanity today and the program is a way to increase the diversity and innovation present in the ideas. The program is founded on the belief that bright ideas need to be championed. During a review, a reviewer can chose one idea that we can empower to be funded. It is more like a VC system wherein each new idea needs a champion behind it. What are the criteria for selection of the grant? The idea presented has to fall within the purview of our research. The applicant has to offer unconventional and bold ideas and make sure his/her idea is innovative. Unlike most programs of this nature, we have tried to streamline the application which is two pages in length and requires no preliminary data. What are the priority areas for the grants? The total number of grants last year was approximately $2 billion, half of which were in global health. We define Global Health in three different areas--infectious diseases, nutrition, and child and maternal health. The fundamental principle that the foundation operates upon is that all life has equal value, and so it aims to reduce inequalities that exists in the world in global health. Grants priorities are vaccines, new drugs and diagnostic tests for malaria and TB. We believe that basic scientific ideas and fundamental discoveries can lead to many different kinds of products. What is your view on the scientific talent in India? This year there were nine grants to scientists in Asia, including one from India. We are excited about the potential of scientists in India and Asia. There is an emerging recognition of Indian scientists in public and private sector. We think excellence is there in India, some of the problems that we are addressing are there in India, so we hope that scientists here can find out better ways and means to deal with them. Shalini Gupta   ]]> <![CDATA["Asia-Pacific is a high growth market and we are investing in this region,"]]> https://biospectrumindia.com/news/95/2351/asia-pacific-is-a-high-growth-market-and-we-are-investing-in-this-region.html https://biospectrumindia.com/news/95/2351/asia-pacific-is-a-high-growth-market-and-we-are-investing-in-this-region.html Wed, 05 Nov 2008 12:55:00 +0530 New Page 1 "Asia-Pacific is a high growth market and we are investing in this region," Dr Poonam Taneja, director of sales, MDS AT US-based MDS Analytical Technologies (MDS AT) is one of leading global suppliers of life sciences tools that comprises two main channel brands-Sciex and Molecular Devices. MDS is focusing on India in a very big way and making aggressive investments. In an exclusive interaction with BioSpectrum, Dr Poonam Taneja, director of sales, MDS AT, speaks about the company's strategies and business. What is the current position of Molecular Devices after it was acquired by MDS Inc.? Molecular Devices is now part of MDS Analytical Technologies division (MDS AT) of MDS Inc. Our three core businessesâ€“MDS AT, MDS Nordion and MDS Pharma Servicesâ€“are global industry leaders in the areas of analytical instruments, molecular imaging, and pharmaceutical contract research. MDS AT is the leading global supplier of life sciences tools that comprises two main channel brands--Sciex and Molecular Devices. Sciex offers market leadership in mass spectrometry and Molecular Devices sets the market-leading standards for high-performance bioanalytical measurement systems for drug discovery and life science research. How do MDC's products support researchers in the life sciences areas? In the life sciences market, Molecular Devices provides genomic and proteomic research customers with instruments and technology for detection and imaging. A growing focus on biomarkers and personalized medicine is driving demand for these solutions. In the drug discovery market, Molecular Devices offers pharmaceutical and biotechnology customers automated systems and technology to screen for potential new drugs. Molecular Devices high-performance, high-throughput tools supports the ever-increasing demand to improve the speed of the complex drug discovery and development process cost-effectively. What are your plans for India? At Molecular Devices, we recognize that Asia-Pacific is a high growth market and we are currently focusing and investing in this region. We provide extensive training to our channel partner in India. We are also establishing a regional dedicated team of MDS-AT technical and service specialists to work with our partner here in India to support the customers promptly, efficiently and effectively. In addition, we are routinely conducting technical hands on workshops, user meetings and seminars in the region and participating in major trade shows. Why have you chosen Chennai-based Spinco as your exclusive distributor now? At MDS, we view our distributors as partners, who contribute significantly to our abilities, products, and services and therefore choosing the right partner is a very critical decision. The distributor partners we work with are known for their professionalism, reliability and customer focus. We optimize these partnerships by providing extensive trainings that includes routine sales, technical and service trainings to all of our partners worldwide. But for the recent two years, Spinco was a Molecular Devices' distributor for over a decade and has provided hundreds of MDC instruments in the Indian life sciences market. Spinco has recently reorganized itself with special emphasis on the life science market with extensive sales and service network. Several global life sciences instrumentation players have set up subsidiaries in India. Are you satisfied with the distribution channel model? At MDS AT our strategy is to support customers throughout India. We believe our distributor partner Spinco is doing a splendid job in achieving that and intend to work with it to grow our business in India, as it has one of the largest network of sales and service offices here to support customers. At MDS AT our focus is to support our distributor partner in India by providing extensive training to the staff. We have observed that, in markets like India, it can be challenging to operate effectively with direct presence alone. To reach out to every city and to every client one needs a very effective network. Some of the companies that have gone direct are also taking assistance through the local partners. How do you compare the Indian life sciences market with the US or EU? If you would have asked me this question several years ago, I probably would have said that new technologies that were being launched in the US and EU were getting accepted in India few months later. However now it is pretty much a level playing ground. Though there could be some pricing challenges, as far as technology acceptance is concerned it is a very global market. The market here has grown astoundingly in the last years. Consequently, we have been focusing on the Indian market and putting in increased resources to reach out and meet customer needs effectively. Is MDS AT planning any acquisitions in the near future? One of the key strategies of MDS AT is to grow the company both organically through development of innovative products and through acquisition and licensing of novel technologies. We recently announced the acquisition of Blueshift Biotechnologies. Blueshift Biotechnologies' cellular imaging technology platform, based on Dynamic Fluorimetry, enables true high throughput screening (HTS) of cell-based imaging assays and is an ideal fit within the MDS AT family of cellular imaging products. The technology provides scientists with information on how potential therapeutics affect cells and cellular processes and allows us to deliver a more enabling and novel product to our customers by leveraging our existing ImageXpress cellular imaging technologies. In short, yes, in order to remain competitive in the markets we serve, we are always looking for opportunities to invest in growth and innovation. Jahanara Parveen   ]]> <![CDATA["India offers significant market opportunities,"]]> https://biospectrumindia.com/news/95/1670/india-offers-significant-market-opportunities.html https://biospectrumindia.com/news/95/1670/india-offers-significant-market-opportunities.html Wed, 05 Nov 2008 12:41:00 +0530 New Page 1 "India offers significant market opportunities," Dr Harry S Rathore, President and Country Head, Lonza India Pvt Ltd In a free wheeling interview, Dr Harry S Rathore, President and Country Head, Lonza India Pvt Ltd, talks about the Lonza's initiatives in India especially in biosimilars along with a sneek peek into its product offerings to the Indian market Can you elaborate on Lonza's Indian Operations which was set up recently? We are expanding our business in India. Currently we are focusing on five major areas â€“sales of the intermediates for the production of APIs used in the ARVs (anti-retroviral) formulations for access-to-medicines markets under PEPFAR. Indian companies such as Aurobindo, Hetero, and Astrix are our customers for these ARV intermediates, in the second area, we are expanding our services and products offerings in the area of Cell Discovery and Molecular Biology. Recently Lonza acquired Amaxa, a market leader in gene transfection into primary cells. Shortly Amaxa product offerings will be available to R&D scientists engaged in biologics research in India, then we have sales and business development of disinfectant formulations for hospitals and pharma clean rooms under the Lonzaguard brand, another arena is building the external-manufacturing-network of Indian companies to outsource production of small molecules to compliment internal capacities of our API plants worldwide. Nutrition ingredients is the other major area where we will soon be exploring marketing opportunities in India. The middle class in India is growing and health and wellness are becoming serious concerns of the Indian families. We see opportunities for our nutritional supplements such as Carnipure especially in functional foods and dietary supplements. Acquiring Cambrex's two businesses was a major deal for Lonza's Life Sciences division in India. Is the company now targeting the API business of Cambrex? Yes, in 2007, we acquired two businesses from Cambrex--Bioproducts which we renamed Lonza Bioscience, and the microbial biopharmaceuticals business which was integrated into the Lonza Biopharmaceuticals business after the acquisition. Now we are not looking at its API business. We have our own small molecules API (active pharmaceutical ingredients) business. Lonza's focus Lonza, which is headquartered in Basel, Switzerland and is listed on the SWX Swiss Exchange, is a major player offering products and services spanning its customers' needs from research to final product manufacture. Lonza is also into production and support of active pharmaceutical ingredients both chemically as well as biotechnologically. The company has strong capabilities in large and small molecules, peptides, amino acids and niche bioproducts which play an important role in the development of novel medicines and healthcare products. In addition to this, Lonza is a leader in cell-based research, endotoxin detection and cell therapy manufacturing and a provider of value chemical and biotech ingredients to the nutrition, hygiene, preservation, agro and personal care markets. In the fiscal year ending December 2007, Lonza delivered strong performance through portfolio changes along with growth in biopharmaceuticals and life science ingredients. The sales were up by 25.6 percent, EBITDA was up 40.9 percent to CHF 682 million, EBITDA margins rose by 2.6 percent points to 23.8 percent of sales and net income grew by 51.3 percent to CHF 301 million How is Lonza cashing on to the biosimilar opportunity? Biogenerics or biosimilars could be a huge opportunity for Indian companies. However there are some initial hic-ups. The regulatory pathway is still not well defined in Europe and the US for biosimilars. Contrary to biogenerics the small molecules generics are relatively easy because they are chemically similar and bioequivalent. In the case of biosimilars, the innovators argue that "the process makes the product" so if you are using different cell lines and different non-infringing process you are getting a different product. That makes life difficult for regulators as to how to enact regulatory guidelines to approve biosimilars. However, momentum is on their side as governments across the globe wish to reduce soaring medical costs. Hence, regulatory agencies are working on enacting the regulations in Europe and possibly in the US. EPO has already been approved for several markets. The domestic markets in India for biosimilars is relatively small because of the affordability of the patients but then we do see that a number of Indian companies have biosimilar programs at different stages of the development and they are looking out for partnerships. Lonza here has the knowledge and expertise of building large-scale biopharmaceutical plants vis-Ã -vis experience in manufacturing recombinant proteins and antibodies on the industrial scale for regulated markets. Our GS Gene Expression System (GS: glutamine synthetase) coupled with the application of the Aggresolve technology from the recently acquired Zyentia Ltd in Cambridge (UK) puts us in the realm of production of antibodies and recombinant proteins. Is the India business model similar to that of the parent company considering that the dynamics are different in India? It is pretty much the same. Lonza is much focused on the customers' R&D and manufacturing needs in clearly defined life sciences markets. Our endeavors are to offer our services to innovator customers throughout the life-cycle of their product leading to generics. India offers significant market opportunities for Lonza's products and services. Any strategic collaborations to look out for in the future? We built a strong rapport with many of our customers and suppliers in India. Now we wish to transform few of these relationships to strategic collaborations. Hygiene and disinfectant formulations, tissue acquisition and cell isolations, production of biotherapeutic media, and R&D services in biopharmaceuticals are some of the areas where we see possibilities of collaborations and business expansion in India. Nayantara Som   ]]> <![CDATA[DNDi: Championing the cause of infectious diseases]]> https://biospectrumindia.com/news/95/2066/dndi-championing-the-cause-of-infectious-diseases.html https://biospectrumindia.com/news/95/2066/dndi-championing-the-cause-of-infectious-diseases.html Wed, 05 Nov 2008 12:24:00 +0530 New Page 1 DNDi: Championing the cause of infectious diseases While cancer and diabetes might be on the rise in the past few years, the proportion of infectious diseases that plague the developing world cannot be ruled out. The world's pharma biggies might be focusing all their attention on lifestyle and non-communicable diseases in the light of the increasing effects of globalization, but it seems that does not undermine the danger that infectious diseases present. A new study by the World Health Organization (WHO) outlining the global burden of disease reveals that four out of the top 10 causes of death globally are infectious diseases. The report outlines the leading causes of death globally as heart disease, stroke, pneumonia, chronic respiratory disease, diarrhea, HIV/AIDS and tuberculosis as according to Colin Mathers, Coordinator for Epidemiology and Burden of Disease at WHO and lead author of the study. India is also not untouched by the burden of infectious diseases. Malaria and Visceral leishmaniasis are largely prevalent in India and affect more than 3 million Indians each year, according to government estimates. India has been increasing the focus of medical research as it bears a large burden of two types of diseases: on the one hand, that of neglected tropical diseases, which represent major health problems, and on the other, an increase in non-communicable lifestyle diseases. These along with India emerging as a pharmaceutical hub with low research costs and large pools of skilled medical research and drug development manpower were some of the reasons why DNDi (Drugs for Neglected Diseases initiative) has been active in the country since 2004. It recently opened its office in India to further its commitment to the cause. DNDi is a collaborative, patients' needs-driven, not-for-profit drug R&D organization that is currently developing new treatments against the world's most neglected infectious diseases such as sleeping sickness (human African trypanosomiasis, HAT), visceral leishmaniasis (VL), Chagas disease, and malaria. It was established in 2003 by Institut Pasteur and MÃ©decines Sans FrontiÃ¨res along with four publicly-funded research organizations in neglected disease-endemic countries such as Kenya (Kenya Medical Research Institute (KEMRI), Malaysian MOH in Malaysia, Oswaldo Cruz Foundation Brazil and the Indian Council for Medical Research (ICMR) in India. WHO/TDR function as the permanent observer. Today, DNDi is a small team of permanent staff in Geneva along with four regional support offices in Kenya, India, Brazil, and Malaysia; an affiliate in North America, and two regional project support offices in the Democratic Republic of the Congo and Japan. Working in partnership with industry and academia, DNDi has built the largest ever R&D portfolio for the kinetoplastid diseases and currently has six clinical and four preclinical projects. Achievements Malaria ASAQ for treatment of malaria in sub-Saharan Africa; launched in March 2007; registered in 23 disease-endemic countries and ASMQ for treatment in Latin America and registered in Brazil in March 2008 and in use by Brazilian national authorities as part of ongoing intervention study (25,000 patients) Visceral Leismaniasis (VL) Lead optimization partnership with Advinus and CDDRI Lucknow VL combination trial to evaluate safe and short-course combination therapy using existing drugs registered in region Paromomycin trial. Over 1,000 patients included in multi-centre trial in East Africa Leishmaniasis East Africa Platform-research capacity strengthening in Africa for VL Human African Trypanosomiasis (HAT, sleeping sickness) Lead optimization partnership to progress molecules from early-stage screening research with Scynexis and Pace University Fexinidazole, first compound mining success from DNDi's nitroimidazoles project; finalizing preclinical studies; will enter first-in-human Phase I trials in early 2009 Clinical trial of Nifurtimox-Eflornithine co-administration-promising study data being finalized; shows for NECT as easier to use, more practical, and safe therapy; full dossier will be submitted to WHO Essential Medicines List in 2008 HAT Platform-research capacity strengthening in Africa for HAT Chagas Disease Lead optimization partnership with Centre for Drug Candidate Optimization (CDCO), Epichem, and Murdoch University (Australia); Federal University of Ouro Preto (Brazil) Pediatric Benznidazole-agreement established with LAFEPE to develop first benznidazole formulation for children that is affordable.   DNDi's activities in India According to Dr Bernard PÃ©coul, executive director, DNDi, "The primary objective of DNDi is to deliver six to eight new treatments by 2014 for these diseases and to establish a strong R&D portfolio. In doing so, DNDi is also working to use and strengthen existing capacities in disease-endemic countries, and raise awareness and advocate for the need to develop new treatments for the most neglected diseases." DNDi opened the regional support office in India in 2005 with support from the India Council of Medical Research (ICMR) to support and catalyze its operational activities in the field of malaria and visceral leishmaniasis (VL). In fact, DNDi is currently carrying out more than 30 percent of its R&D activities in India. "India has an important role to play in the fight against infectious diseases. What is needed is a political leadership to start and sustain the efforts in "essential health R&D' and redefine the R&D priorities to initiate and stimulate research for neglected diseases." Work on Visceral leishmaniasis In December 2007, DNDi signed a five-year collaborative agreement with Advinus Therapeutics as primary partner in lead optimization consortium for VL. The project is to obtain optimized leads by processing "hit" molecules with good safety profiles and proven activity against Leishmania parasites. This consortium brings together expertise in chemistry, screening, pharmacology, and pre-formulation in order to optimize a molecule's drug properties to be orally absorbed and reach the bloodstream, be distributed effectively to infection sites, remain intact in the body to kill the parasites, and yet not harm the patient. With a full team in place, Advinus Therapeutics in Bangalore has identified two promising series of compounds and conducted an assessment of the first series of synthetic compounds and initiated chemistry-biology activities. Screening at the Central Drug Research Institute (CDRI), in Lucknow, began in 2008 for in vitro and in vivo biological activities. Ongoing clinical trials on drugs for Malaria and Visceral leishmanisis MALARIA While clinical trials for ASAQ have been conducted, the clinical research for ASMQ has just started. Malaria is present in over 100 countries and threatens half of the world's population. In sub-Saharan Africa, it is the single leading cause of death for children under five. It is unevenly distributed in India-80 percent of the population lives in low transmission areas and 20 percent in a high transmission belt. India holds 77 percent of the South-east Asia's malaria burden. The region also witnesses a large number of P. falciparum cases (up to 50 percent) and chloroquine resistance. ASAQ: A clinical trial studying tolerability and effectiveness in real-life conditions has recently been conducted for ASAQ, the fixed-dose combination of artesunate (AS) and amodiaquine (AQ) for its eventual registration in India. The drug was launched in 2007 by DNDi in an innovative partnership with Sanofi-aventis. The study was carried out in partnership with the Indian Council of Medical Research (ICMR) and National Institute of Malaria Research (NIMR), namely in Orissa and Jharkhand regions and the study results were recently presented at the XVII International Congress on Tropical Medicine and Malaria. Status Clinical trials in India (N=300) 2 sites (Ranchi and Rourkela) enrolled 300 patients Study completed in Q12008; Results presented at ICID and ICTM17 in 2008 Consistent with previous studies with ASAQ in Africa Supports consideration of ASAQ as 1st-line therapy in India where appropriate ASMQ: This new fixed-dose combination of artesunate (AS) and mefloquine (MQ), developed by DNDi and Farmanguinhos/Fiocruz, was successfully registered in Brazil in March 2008. To facilitate its future availability in Southeast Asia, upon approval from the ethics committee and the relevant national and local authorities, further clinical research is being conducted in the Goa and Mangalore regions in association with ICMR and NIMR. Further enabling the Southeast Asia expansion, Farmanguinhos/Fiocruz has agreed to the principle of technology transfer to the Indian pharmaceutical company, Cipla. Status Clinical trials in India (N=84) Dec 2007: Enrolment started at2 sites (Goa; Mangalore). 77 patients enrolled (Sept 08) End of enrolment expected in Q42008 Results expected by Q32009 VISCERAL LEISHMANIASIS (VL) Clinical trials are on for VL combination therapies of Ambisome (lipid formulations of Amphotericin B), paromomycin, and miltefosine. Leishmaniasis affects approximately 12 million people in 88 countries. The seven most affected countries represent over 90 percent of all reported new cases. India has about 1 lakh new cases of VL annually, of which approximately 90 percent are from Bihar. Until recently, pentavalent antimony complex was one of the very few standard VL treatments, despite all of its limitations: toxicity, lengthy treatment, and growing resistance. Presently, amphotericin B, paromomycin, and miltefosine have been evaluated and officially approved by all relevant authorities for the treatment of VL in India. All of these drugs have advantages and disadvantages with regards to cost, toxicity, length, and ease of administration. Therefore, to reduce the treatment period, to increase compliance, and to reduce the possibility of resistance developing, DNDi and its partners are investigating the use of combinations of these drugs to treat VL. A clinical study to evaluate various drug combinations has been initiated in collaboration with ICMR and the Rajendra Memorial Research Institute (RMRI), at Patna, the Kala-azar Medical Research Centre (KMRC), and GVK Bio at Muzaffarpur. This project will be extended to Nepal and Bangladesh. The data collected will be used to make a recommendation to the national control programs in highly endemic areas of VL in the region. A total of 147 patients have been recruited so far out of the proposed 640 for clinical trials. Enrolment will continue through 2009 and the results are expected by early 2010.   Shalini Gupta     ]]> <![CDATA[Pharma-biotech partnership balance shifts]]> https://biospectrumindia.com/news/95/2860/pharma-biotech-partnership-balance-shifts.html https://biospectrumindia.com/news/95/2860/pharma-biotech-partnership-balance-shifts.html Wed, 05 Nov 2008 12:11:00 +0530 New Page 1 Pharma-biotech partnership balance shifts Impact: Under the cover of credit crunch, big pharma is likely to swoop repeatedly to acquire substantial biotech targets The impact of the credit crunch on the corporate world is "the abrupt loss of cheap debt". However, the big pharmaceutical companies have stayed out of the cheap debt game and as a result, the credit crunch will actually play out as a net positive for an industry much in need of good news. According to Dr Chris Phelps, head of company analysis at Datamonitor, pharma companies are not only expected to weather the financial storm successfully but to also use this period to exploit their unique cash strength by embarking on an acquisition spree. The average net debt as a proportion of capital employed for the top 20 pharmaceutical companies is just six percent, while the average net debt carried by financial institutions is 95 percent. This fact alone suggests that the fallout from the credit crisis will not be as significant in the pharmaceutical industry as in other more highly leveraged sectors. According to Datamonitor, when this is combined with the fact that the average top 20 pharma company has access to $7.5 billion in cash, equivalents and short-term investments, the ability of large pharma companies to weather the credit storm is very clear. Impact on Asian market Although the credit crunch has no direct impact on the Asian pharmaceutical industry like the global pharmaceutical industry but it will have some impact on the niche and upcoming biotechnology sector which is heavily dependent on financing and venture capital or government support. "The growth rate of our sales for the current fiscal year will be affected as compared to the previous years. The volatility in the currency will hit hard the end users, as India is very price sensitive market. The companies might tighten their budget on R&D," -Mr S Thyagarajan, Chairman, Spinco Biotech, Chennai "The pharmaceutical industry is relatively recession-proof unlike other industries which are already facing the pinch. However, the biotechnology industry will have a hard time ahead as these companies will likely face a problem in raising capital." -Dr T J Deng, Senior Director, BioDuro, Beijing, China Sharing his concerns on the crisis and impact on Chinese pharma market, Dr T J Deng, Senior Director, Bioanalytical DMPK & Analytical Chemistry at BioDuro Beijing, China said, "The pharmaceutical industry is relatively recession-proof unlike other industries which are already facing the pinch. However, the biotechnology industry will have a hard time ahead as these companies will likely face a problem in raising capital. Also, the valuation of these companies might drop when they look for being acquired by big pharma companies. But for CROs, it is a good time as outsourcing might increase in the coming months. Though there is a possibility that mid-size companies in the US and Europe might withdraw their orders. This might put small-sized CROs in a fix. Coming to the manufacturing front, the Chinese API companies will end up with marginal profit due to volatility in currency and rising costs. The only companies that can sustain the pressure are the big pharmaceutical companies that have huge capital. Sharing similar views Dr Prasad Kanneganti, Quality Operations Director, Pfizer-Asia Pacific, Singapore, states that the pharma industry is recession-proof. "During recession people become too stressed. They need to take care of their health and need rather more medicine. I think this is a correction phase for the industry. The companies that do diligent homework will survive. India and China have better chance of receiving outsourcing business. On the other hand, the biotech companies, I guess, might face some problems," he says. Meanwhile, Singapore assured the scientific community that government funding for scientific research and development, that helped push it to a record 2.6 percent of gross domestic product last year, will not be cut in the current economic downturn. "The government is fully committed to its investment in R&D as a vital driver of the economy for the future," promised Mr Lee Hsien Loong, Prime Minister of Singapore while speaking at the opening of science and technology research and development center Fusionopolis in mid-October, this year. "The current economic crisis in the US and Europe will be a boon for the CROs in India and China particularly the Indian firms," believes Dr B S Patravale, President of Aarti Industries, a custom synthesis and contract research company from India. Reacting to the crisis, Dr Sureerat Prachartum, Vice President, Thai Pharmaceutical Manufacturers Association, Thailand, says: "At present we don't see any impact on our pharmaceutical industry. The companies that are involved in export might get affected. But in Thailand there are hardly any companies that are involved in pharma exports." While making comments on research activities, Dr Uthai Suvanakoot, Associate Professor, Chulalongkorn University, Bangkok, Thailand said, "We don't feel the heat of credit crunch on our research initiatives in Thailand." Smaller countries are also not unsettled by this. Talking about the impact on the Sri Lankan pharma industry, Mr Thusitha Wilegoda, Managing Director, Labmasters, Sri Lanka, said, "For next three-four months, I think, the crisis will not have any impact on the industry. The small local pharmaceutical manufacturing industry in Sri Lanka like the one in Bangladesh, Nepal might face problem if the problem lasts for long. On the other hand the R&D institutes that are receiving foreign grants are likely to face problem in near future." On the contrary, the bio suppliers sector in the region might face some problem. Mr S Thyagarajan, Chairman, Spinco Biotech, a leading bio supplier from India notes that the crisis will affect the revenue in the coming months. "The growth rate of our sales for the current fiscal year will be affected as compared to the previous years. The volatility in the currency will hit hard the end users, as India is very price sensitive market. The companies might tighten their budget on R&D," he adds. Pharma-biotech partnership balance shifts While the credit crunch promises to strengthen large pharma, the outlook is far from positive for small biotech players. The biotechnology companies and research organizations that are dependent on finance from venture capital and financial institutions are likely to face problems in raising capital for their further research and clinical research/trial activities. Either they have to look out for partnerships with the big pharma companies which are already headhunting for acquisition of smaller biotechs with good number of molecules in product pipeline or to be acquired by these giants. Over the last decade, the pharma industry has increasingly looked at the biotechnology sector to help replenish its dwindling product pipelines. A symbiotic relationship has been established whereby biotechs provided innovative therapies and in return, pharma firms pumped-in funding and development know-how. A natural balance was established in the pharma-biotech relationship: risk and reward were shared. However, in recent years biotech's access to funding from other sources of capital has become easier. Financing became cheaper and the balance of power in the pharma-biotech relationship shifted: pharma's need for access to biotech products increased significantly, while biotech's need for pharma funding diminished. Consequently, biotechnology companies could afford to either carry more risk themselves by taking their projects deeper into clinical development or by demanding more favorable terms from the increasingly desperate pharma industry. This shift in power towards biotech companies is reflected in the declining number of licensing deals between pharma and biotech companies," Dr Phelps elaborates. The current credit crisis it appears is set to change again the balance of power in the pharma-biotech relationship. Biotechnology companies' ready access to capital and funding has dried up almost overnight, and while there are few that will struggle immediately, the funding of their operations in the long term looks more difficult. In terms of licensing deals biotech companies will be forced to accept less favorable terms. According to Dr Phelps, under the cover of the credit crunch, big pharma will swoop repeatedly to acquire substantial biotech targets. Narayan Kulkarni in Singapore   ]]> <![CDATA[Budget '09 The Countdown begins]]> https://biospectrumindia.com/news/95/2082/budget-09-the-countdown-begins.html https://biospectrumindia.com/news/95/2082/budget-09-the-countdown-begins.html Wed, 05 Nov 2008 11:46:00 +0530 New Page 1 Budget '09 The Countdown begins Over the years, the Finance Minister has been giving life sciences due emphasis in his budget decisions. As the industry awaits Finance Minister P Chidambaram's last budget before the general elections kicks start in early 2009, industry stalwarts give their wish list to the minister. The overall Union Budget 2008 has clearly reinforced the strong image that India will attain on the world economic stage. But at the same time, the Manmohan Singh government's budget proposal 2008, sent out one clear message that life sciences as an industry can certainly not be ignored primarily due to the mammoth growth opportunities that it brings along with it and the significant investments happening both by domestic companies and MNCs in the sector. Budget over the years Budget 2006 1. Corpus for the R&D fund to be increased in phases. Stable policy environment and incentives to be provided to help the two industries (biotech and pharma) become world leaders. 2. Units in knowledge-based industries such as pharma and biotech to be provided equity support through the SME Growth Fund. 3. The exemption date for weighted deduction of 150% of in-house R&D facilities of pharmaceutical and biotechnology companies has been extended by 2 years to March 31, 2007. 4. Also, the exemption for 100% deduction of profits of companies carrying on scientific R&D, which is approved by the Department of Scientific and Industrial Research has also been extended by 2 years to March 31, 2007. 5. Customs duty for 9 specified pharma and biotechnology machinery cut to 5%. 6. Corporate tax pruned to 30% from 35%. Budget 2007 1. Reduction of customs duty on 10 anti-AIDS and 14 anti-cancer drugs to 5%. 2. Reduction of duty on certain life saving drugs, kits and equipment from 15% to 5%. These drugs will also be exempt from excise duty and countervailing duty (CVD). 3. Expenses on free samples of medicines and medical equipment distributed to doctors exempt from fringe benefit tax. Budget 2008 1. Reduction in excise duty on all pharmaceuticals from 16 per cent to 8 per cent as well as total exemption from excise duty for the anti AIDS drug, Atazanavir. 2. Increase in budget allocation for polio elimination program (Rs10.42bn) and for AIDS control program (Rs9.93bn) which could be positive for companies like Panacea, Matrix, Ranbaxy, Cipla. 3. Further allocation for the health sector has been increased by 15% to Rs165.3bn. 4. Certain specified life saving drugs and their bulk drugs customs duty has been reduced to 5% from 10% as well as total exemption of excise duty. 5. Weighted deduction of 125 per cent on any payment made to companies engaged in research and development for promoting outsourcing. 6. Grant of five year tax holiday to encourage hospitals to be set up anywhere in India, except certain notified areas in tier-2 and tier-3 towns (for period April 1, 2008 to March 31, 2013.   Industry Wish list The past year has seen a lot of events unfolding in the Indian life sciences industry-a spree of acquisitions, the prominent one being the Ranbaxy-Daiichi Sankyo deal leading to the forging of stronger Indo-Japanese relations; MNCs setting shop in the country and even India Inc going overseas and etching a name for themselves on foreign land. Given this scenario a lot of budget expectations are soaring high on the eve of 2009 budget announcements. The UPA's Budget 2008 might have been lauded by industry stalwarts but there have been unfulfilled expectations which the industry hopes will be addressed this year. BioSpectrum has been able to put together the recommendations and suggestions from different sectors of the life sciences industry as the government makes an early start to its election year budget planning CRO "We would like the same exemptions from service tax on generic research as New Drug research. The generic drugs are the drugs used by the masses and will benefit general population so should be encouraged. Moreover the Indian drug companies are doing this research for selling the drugs in the international market so it brings in export revenues. The CROs should get the same benefits of taxation and customs as in-house R&D units in pharma cos. Such as customs relief on lab equipment and IT benefits under section 80IA. -Apurva Shah and Binoy Gardi, Co-Founders and Co-Group Managing Directors, Veeda Clinical Research I would like to see the government recognize clinical research as industry separate from biotechnology. -Sampath Kumar, Founder and CEO, Sristek BioSuppliers All the imported consumables which are not used as commercial end product but are only used in R&D should not attract any custom duty The transaction from bonded warehouse should be more flexible, like one page single document should be sufficient from customer to get the goods cleared from the warehouse and should be valid for six months in place of bunch of papers for each transaction even for $ 100. India is lacking in terms of high precision capital equipment manufacturing used in drug discovery / molecular biology / biochemistry R & D and hence government should come forward and shake hands with private industries to manufacture the same here. Products for malaria and syphilis detection should attract no Import Duty and must be treated as critical products in line with HIV, HBV, HCV. Malaria and syphilis tests are mandatory to be carried out on each unit of blood donated. Abolition of the Excise duty from the Laboratory Chemicals since these products are used in the analytical labs and for the research purpose. Elimination of the ED shall help in reducing the cost structure for the scientists and shall boost the R & D activity. The MRP on the labels of laboratory reagents should be eliminated: This was initiated at the beginning of the current financial year, since these products reach the consumers (who are part of the industry and research institutions) directly at discounted rates hence the MRP does not hold much value. The legal procedures for getting all the desired licenses mandatory for the laboratory solutions business for e.g. Solvent Storage license should be made as simplified as possible so that attaining the same and adhering to them is easier. -Sushil Mehta, MD, RFCL To better the supply time and to reduce hassle in order processing, it would be good to bring the custom duty for the dealer import and end customer import to same level. Currently DSIR labs, Government institutes and pharma get special customs duty due to which they import product directly from the manufacturer abroad instead of buying locally in local currency. Especially the Government institutes spend lot of time in tenders, comparing different currencies and different payment terms, freight cost. Lot of valuable scientific time is spent on order processing. If the customs duty is brought to similar level all offers will be in Indian Rupees and it is easy to compare as well as get product immediately from the dealer stock. Also, the dealer can import in bulk and pass on the benefit to the customer. A lot of companies are interested in doing assembling in the country to take advantage of the growing business. If parts are bought on CKD basis and assembled in India special custom duty should be considered. This point is connected to the point one, since the customer pay less duty for direct import from countries like Germany they tend not to buy the assembled product. - Sankaranarayan, MD, Eppendorf India In the absence of any mandatory regulatory framework like compulsory accreditation of clinical testing laboratories, labs in India look at following quality practices as a "Cost". Until the government comes up with policy statement on this issue it is prudent to encourage labs to follow internationally accepted Quality control practices by making them available at lower prices. Reducing the customs duty from the current 31.74% to Nil (as is done in the case of Elisa products to promote HIV testing) will go a long way in achieving this objective. Lesser duties for the life science research products like consumable and instrument should be passed on all the labs engaged in the R&D activities in the country. - Dhiren Wagle, Country Manager, Bio-Rad Biofuel The recent biofuel policy declared by the Government of India has been well supported to the industry particularly in the down stream side. However, to achieve the 20 per cent blending mandate, the following points needs to be addressed.  It should be addressed as to how the various Government Ministries like Rural Development and Panchayat Raj will work towards achieving this objective of planting 35 million acres under bio diesel plantations. NREGA scheme (routed through the Rural Development Ministry) can be utilized to promote the bio fuel plantations across the country. Many of the villages have common land and waste lands which can be put under bio fuel plantations under the NREGA scheme. The harvest from bio fuel plantations will provide a source of revenue for the panchayats later. Yields from bio diesel crops are obtained from the third year onwards. Most of the farmers are not willing to invest their money on bio diesel plantations because of this gestation period. Hence banks and insurance companies should play an active role in providing finance and crop insurance to farmers and entrepreneurs undertaking bio diesel plantations. The Government should also provide subsidy to farmers undertaking bio diesel plantation. A single agency with offices in every state should be made in charge of this subsidy. Farmers should receive subsidy for bi o fuel plantation in reasonable time and with minimum effort. To bring in 35 million acres under bio diesel plantations, planting material to the tune of 3500 million to 35,000 million is required depending on the crop chosen. A certifying agency to certify the variety of the planting material needs to be established failing which fly by bight operators selling poor quality planting material will be active. The 10 year bio fuel target has to be broken down into shorter phase wise targets from 5 % to 20 %. The short term targets will make the various other stake holders like vehicle manufacturers, procurement companies, logistics companies, oil expelling units and others to gradually prepare themselves. The Minimum Support Price (MSP) per kilogram of the feedstock (Jatropha seed, Pongamia seed) should not be more than 20 % of the price of diesel. If feedstock prices are greater than 20 %, bio diesel production becomes unviable. Ex: If the current price of diesel is Rs 30/ liter, the price of Jatropha or Pongamia seeds should not be more than Rs 6/ Kg. Finally government should release the list of bio diesel crops which can be planted by the farmers and be eligible for various subsidies. Government should also try to promote bio diesel plants native to each region. Some State Bio fuel Boards are active while some are inactive. Each of these Bio Fuel Boards have different mandates and different focus. The National Bio Fuel Coordination Committee and State Bio Fuel boards should work towards a common objective. All these suggestions will help India to reduce dependence on crude oil, provide employment in rural areas, rural industrialization, additional source of income for various stakeholders including farmers and self sustaining without any oil subsidy from the government. - C S Jadhav, Director Marketing, Nandan Biomatrix Medical Equipment Manufacturer The government needs to recognize medical technology as an industry, which is reeling under unprecedented tax burden (36 per cent). There was no special mention made for the industry and no reduction in custom duties for the import of medical equipments/devices in the previous year's budget. The government has not given any incentives like capital grants and subsidies for local manufacturing of medical devices as well. The Finance Minster has proposed to increase its healthcare allocation by 21.9 per cent and has extended a 5 year tax holiday for setting up hospitals in non- urban cities, but this however will not reduce the cost of healthcare in the country, until the cost of medical equipments are reduced. Health of the common man has been neglected and so has been the government's attitude to the Indian medical equipment manufacturer. - Dr. G S K Velu, Managing Director, Trivitron Group of Companies, India & Overseas Pharma As far as incentivizing R&D initiatives are concerned, the government has allowed weighted deduction of 125 per cent on any payment made to companies engaged in Research & Development, to promote outsourcing of research. However, no additional fiscal incentives had been proposed for R&D activities. Since discovery research is lengthy and expensive, OPPI recommends that present R&D incentives should continue till 2017. - Tapan Ray, Director General, Organization of Pharmaceutical Producers of India All the budget allocations are vanity if the government does not act. One of the greatest challenges the Government faces is its ability to see that this benefit really reaches the people to whom it is meant for, and that these projects get implemented within the framework of budget and time. According to a recent review by the government, 301 planned projects were delayed up to 96 months with the cumulative cost over run of more than Rs 48,000 crore. This urgently calls for better governance and active involvement of all the ministries involved in health, education and infrastructure. - Habil Khorakiwala, Chairman, Wockhardt We hope the FM pays heed to the long standing request of industry to do away with FBT on physician samples and also tones down the penalties on transfer pricing adjustments. A major disappointment was the lack of investments in infrastructure. The economic engine cannot continue to grow at 9 per cent if no investments are made in this sector and this was notably missing. - Ranjit Shahani, President Bombay Chamber of Commerce & Industry (BCCI) and Vice Chairman & Managing Director, Novartis India Biotech/Biopharma There is an absence of industry ready scientific research workforce, which is one of the major constraints in the growth of biotech sector in India in spite of large number of graduates and postgraduates who are academically qualified. Innovation based smaller companies or start-ups cannot invest in training and even a service oriented biotech cannot wait for the training, as capable hands are required at short notices. An initiative like Institutes of Biotechnology on the lines of IITs, focused on practically ready workforce could have been a step in this direction. Provision for initiatives with longer lasting impact like these, seem relatively less. - Supreet Deshpande, Founder & CEO, VLife Sciences Technologies Pvt Ltd Effect of the global meltdown / Current economy crisis It might have been an action packed year for the life sciences industry. But the year 2008 will also be remembered for a sudden spurt of economic turmoils in the form of an 11.7 per cent inflation shooting up oil prices in particular, then global meltdown which had its rippling effects even in Indian shores. Fear now looms as to whether India should be prepared for a recession. However is the life science industry effected in any ways and will that in any way effect the budget proposals 2009. Back in life sciences, there is an apprehension that the Government can cut down in R&D expenditure. Said a well known figure in the of a pharma company and who did not wish to be quoted, "The ones mainly effected would be companies heavily invested in R&D and that too for companies outside India and who will now have to face increased cost pressure now." A sneak peek whether or not life sciences has been affected: CROs on the whole are not affected by the global turmoil. This sector is not really affected by mainstream economic market dynamics. In fact now, pharma companies in the US, which are now facing hurdles of high cost pressures will outsource all the more. They will outsource their clinical research work to these CROs which will lead to a further boost in their business. Yes, I do agree that share prices have been impacted but it is not that drastic for CROs. - Anurag Sharma, William Blair International Limited, London, UK With regards to the current global financial crisis, I think generally there is going to be a slow down, even though the impact on CRO industry will be lesser than other industries. The critical factor in all this will be how the banking industry shapes up. As long as Governments all across the world ensure that banks function normally and continue to lend to businesses, we will be able to recover sooner than expected" - Sampath Kumar, Founder and CEO, Sristek Currently we are not seeing any major signs of cut in R&D expenditure from government funded labs even though there is a global economic meltdown. The main thing affecting the scientific instrument industry is the currency conversion rate. The US dollar and Euro have appreciated vis-Ã -vis the rupee by approx 20-25 per cent in the past 4 months. This is forcing scientists to either postpone their purchases or compromise on instrument specifications to fit their purchases within budget. The inflation and rise in fuel prices has increased business expenditure on travel, supply chain, across the board for all industry. This is resulting in increased pressures on margins for the scientific instrument industry. - Dhiren Wagle, Country Manager, Bio-Rad The budget proposals of the last few years clearly shows that there has been a significant decline in the customs duties in recent years. India has spontaneously deducted customs duties without having been influenced by foreign sources. However, the industry leaders are very apprehensive about further decrease pertaining to custom duties because it is exceedingly being felt that chances of further deduction is a rare possibility in the forthcoming budget considering the impact of inflation and the global meltdown. Also, as the next general elections should be completed before May 2009. Hence the budget session of Parliament this year is not expected to present any new things in the budget. Upadhye, MD, LabIndia says, "I do not think if anybody will consider our requests this time. Parliament might just pass the routine expenses to be carried out till the new government takes over." Therefore it is important that this Union Budget looks into the implementation aspects, maintains the projects that are already launched and thus makes the life sciences and healthcare delivery more efficient. Jahanara Parveen with inputs from Nayantara Som & Shalini Gupta ]]> <![CDATA[Biotech companies keen on setting up R&D factories]]> https://biospectrumindia.com/news/95/4668/biotech-companies-keen-on-setting-up-rd-factories.html https://biospectrumindia.com/news/95/4668/biotech-companies-keen-on-setting-up-rd-factories.html Wed, 05 Nov 2008 11:25:00 +0530 New Page 1 Biotech companies keen on setting up R&D factories With so many Indian and multinational companies establishing their R&D centers here, it is clear that India is poised to become the R&D hub of the global life sciences industry. DuPont India Investment: Rs 100 crore Area: 15 acres Location: Hyderabad R&D in Indian industry has witnessed a paradigm shift in the last decade. Today, the strategic focus of most of the Indian biopharma, pharma and agribiotech companies has shifted to research driven business. Indian companies are now willing to take the risk of investing big money in research and development. The last few years have seen a lot of companies like Avesthagen, Dr. Reddy's, Biocon, Dabur, Panacea Biotec, and Bharat Biotech making substantial investments in establishing, upgrading and expanding their R&D infrastructure in an effort to ascend the research value chain and sustain global challenges, competitiveness, and avail the opportunities. And in a short span of about five or six years, some of these companies have significant R&D milestones to their credit. For example Bharat Biotech has invested almost Rs 30-35 crore this year on R&D. For the malaria vaccine and rotavirus program, the company is about to invest Rs 25 crore. Biocon made an investment of Rs 150 crore on BioMAb EGFR, the anticancer monoclonal antibody. Thus, all these companies came out with new research models that changed the position of their companies. Focusing on R&D and innovation has now allowed the Indian life sciences companies to move further up the value chain, and thereby increase their profitability. Indeed, the cost of doing R&D in India is a big advantage, along with other factors like scientific talent, patent protection, and a large patient pool. MNCs expand their R&D presence MNCs are looking at India in a big way and are making huge investments to set up R&D centers in the country. The nation has attracted numerous multinationals like GSK, AstraZeneca, Monsanto, AMRI, Pfizer, Novartis, and DuPont to establish their research and development centers here, bringing the number of foreign-funded R&D centers to more than 100. With the new emerging trend of internationalization of R&D, MNCs are targeting developing countries in Asia for setting up their dedicated R&D centers. The skilled manpower and the reasonably developed infrastructure have been drawing a number of MNCs to the shores of India for setting up their dedicated R&D centers. From education point of view, India is well designed to accommodate any kind of research and development initiative. India has now become the obvious choice for setting up the competence centers, going by the size and opportunity in the country. The big names of the global biotech industry already have development centers in India, and are planning to further expand their existing facilities and infrastructure. A lot of them are carrying out a significant proportion of their R&D work in India, which contributes to their overall growth and success. Some of these companies have their largest development centers outside the US in India. Rasi Seeds Investment: Rs 10 crore Area: 40,000 sq. ft. Location: Attur, Tamil Nadu DuPont India, a subsidiary of E I du Pont de Nemours and Company recently opened the first biotech research facility at the DuPont Knowledge Center (DKC) in Hyderabad. The Biotech Research Center (BRC) began its operations with more than 80 scientists working on a variety of global research programs on plant and industrial biotechnology. The India center is the first integrated agriculture and industrial biotechnology research center for DuPont outside the US. The other research facilities at the DKC will come up in phases over the next couple of months, and the complete DuPont Knowledge Center is expected to be formally inaugurated sometime before this year-end. The BRC at DKC will focus on bringing new crop genetics to the market faster and on application of industrial biotechnology to produce biofuels and biomaterials for global markets. Plant biotech scientists at the DKC will work on developing biotech traits and technologies that will be incorporated into multiple crops for markets the world over. The trait discovery work conducted on site will help create advanced seed products to meet the growing global demand for increased food production, improved animal feed products and expanding energy needs. Research teams will work to deliver new technologies and products for the DuPont Agriculture & Nutrition platform and the DuPont Applied BioSciences business for India and global markets. Both research teams will work together to develop products from renewable resources for food, feed, materials and energy. Starting with more than 80 crop geneticists and industrial biotech scientists today, DuPont expects the number at the BRC to double by the year end. An estimated total of 600 scientists and engineers across all disciplines will work out of DKC once it is fully functional. Emphasizing the significance of the DuPont Knowledge Center, Balvinder Kalsi, president and CEO, DuPont India, said, "The DuPont Knowledge Center will provide substantially increased competitiveness to build the future of DuPont and contribute to DuPont India's growth. I expect DuPont Knowledge Center to be a global Center of Excellence for DuPont. This will enable us to increase our 'speed to market' with products that come out of our R&D and innovations pipeline, not only for India but also for other growth regions". By adding biotechnology to DuPont strengths in chemistry and material science, our scientists at DKC will work to develop biocatalysts that will utilize renewable feedstocks to deliver sustainable innovations to global markets, he added. Krishidhan Seeds Investment: Rs 5 crore Area: 3000 sq.mt expansion Location: Jalna The DKC in India is very important to the global R&D and innovation strategy of DuPont. This center reinforces the importance of India, and the city of Hyderabad, as the emerging center of knowledge excellence, particularly in the new scientific disciplines of biotechnology, bioengineering, bioinformatics, nanotechnology and other emerging sciences. The DKC at Hyderabad will undertake basic research and product application development across all five of the business growth platforms for global and local markets, as well as offer other knowledge services to DuPont businesses. DuPont today has major plant biotech research centers in Delaware, Iowa and California along with 90 plant genetics research centers around the globe. Globally, DuPont has more than 50 R&D facilities, 20 in the United States and 30 in 11 other nations. The company invests an average of $1.3 billion annually on global research and development in a diverse range of technologies for many markets including agriculture, automotive, construction, electronics, chemicals and industrial materials. Today, DuPont has more than 5,000 scientists and engineers around the world. Today, DuPont India, with more than 900 employees and growing at more than 25% every year, markets a wide range of products in various market segments. The company has six production facilities in India in three locations for DuPont Crop Protection, DuPont Engineering Polymers, DuPont Refinish, and Pioneer hybrid seeds. R&D activities in agribiotech is still very nascent in India today and dominated by public institutions such as Indian Council for Agricultural Research (ICAR) and the Universities as opposed to private companies in the developed world. It is very recently that the Indian agribiotech companies started focusing on innovation, and are making huge investments to set up R&D centers in the country. The Bt cotton leader Rasi Seeds has recently created a new state-of-the-art biotechnology laboratories and crop breeding facilities at Attur, near Salem in Tamil Nadu which has been set up with an investment of about Rs 10 crore. The new R&D facilities have laboratories for biotech research, crops research, germ plasm conservation, insect bioassay laboratory, library and documentation, and other facilities that cover an area of 40,000 sq. ft. The company has created excellent and modern facilities for undertaking crop biotech research with dedicated and proficient scientific staffs. The biotech labs are equipped with all the modern equipment such as PCR machines, refrigerated centrifuges, DNA gel documentation system, various DNA electrophoresis systems including nucleotide sequencing facility, freeze-dryer and various other equipment. A new transgenic greenhouse following the biosafety guidelines of the Department of Biotechnology (DBT) has also been created. In addition, the R&D center is well equipped with infrastructural facilities that include research farm of 140 acres, 5,500 sq. mt. transgenic greenhouse, seed quality control laboratory, and a state-of-the-art seed processing facilities. The center also has a plant molecular biology laboratory for carrying out crop biotechnology activities, a tissue culture facility to undertake genetic transformation of desirable genes in crops is fully functional. Biovel (R&D and Production facility) Investment: Rs 50 crore Area: 1 lakh sq.ft Location: Bangalore The main research focus of the research center will be on the use of molecular biology tools such as Marker-Assisted Selection (MAS) in crop breeding, and development of transgenic crops. The emphasis will be on development of DNA markers for complex traits that include quantitative traits such as yield and quality in different crops, and pest and disease resistance in selected crops. Further, genetic engineering techniques will be used for developing resistance to virus diseases in crops such as cotton, okra, tomato and cassava and pest resistance in crops such as rice, brinjal, and okra. Dr V Subramanian, vice president-biotechnology, Rasi Seeds, shared, "The future thrust of our center would be on marker-assisted selection using DNA markers for several important traits in crops such as rice, wheat, cotton and vegetables. This will involve integration of crop breeding and biotechnology including bioinformatics." We also will intensify our transgenic research in different field crops and vegetables for agronomically important traits besides quality traits, he further added. Krishidhan Seeds too has expanded its R&D operations and strengthened its research facility with additional 3,000 sq.mt building for biotechnology in Aurangabad, Maharashtra and recruited 44 scientists and breeders from public and private sector. The company made an investment of Rs 5 crore in infrastructure of Krishidhan Research Foundation, a 100 percent subsidiary company of Krishidhan, which is completely focused on research. It included improvement of farms, addition of about 100 acres of land, modernization of biotech lab to take up both applied and basic biotech research. Krishidhan has also created a Gene bank within the company with modern infrastructure for storage and cataloging. Having tackled boll worm complex through Bt, the company has started a consortia mode research for development of resistance against sucking pest hetrosis and drought in cotton. The research team at Krishidhan has also taken the initiative to get insect resistance gene from one of the national institutes of ICAR and started developing IR in key vegetable crops. The program for IR brinjal is now at advanced stage. The company saw a revenue growth of 50 percent over the previous year, 62 percent of this growth came from biotech crops. Biovel Life Sciences has also expanded its research facility and set up a new production facility in Bangalore. The company has a multi disciplinary research and development center with fully equipped modern infrastructure coupled with highly qualified and accomplished scientists who have made significant contributions in the field. The main focus of its R&D is development of vaccines, biopharmaceuticals and drug delivery. The company aims to add value to the products technically and capture the market through developing biosuperiors from biosimilars using the novel delivery technologies, conjugation technologies, etc. The company has two buildings dedicated for the R&D which are for conducting the molecular biology, protein purification, protein characterization, conjugation techniques, and cell culture work. Biovel is also setting up facilities for research work in drug delivery and monoclonal antibodies. "Our philosophy is to cooperate, collaborate and co-develop, and with that attitude Biovel has entered into the collaboration with several national and international companies for technology transfers and co-development of products," shared Dr Durgaprasad Annavajulla, director- technical, Biovel Life Sciences. We believe that Biovel will carve out its place through the breakthrough research in the area of biotechnology. To achieve this we are recruiting very prominent scientists who have vast experience in their respective fields nationally and internationally, he added. Biovel is currently working in the segments of cardiology, endocrinology, vaccinology, dermatology and oncology. Biovel has a long R&D pipeline which mainly includes-the dermal products; streptokinase and pegylated streptokinase for the treatment of myocardial infarction; recombinant human growth hormone-the company obtained the technology with global marketing rights for producing the human growth hormone (hGH) from the Dow Pharmaceuticals, US, which has patented Pfenex expression system. Biovel is working on scale up followed by testing the material in animals and humans and has the patent rights of Dow Pharma in producing the material from the Pfenex system. Biovel has in house expertise in producing and purifying the polysaccharide vaccines. Hence, Biovel took up the project of producing quadravalent meningitis vaccine and as part of it, Biovel obtained all the strains A, C, W and Y and it is producing all the vaccines and characterizing them. Biovel has already produced and finished the clinical trials of vi-polysaccharide vaccine and is working on conjugation of the polysaccharide vaccine with carrier proteins like Tetanus Toxoid (TT). In addition to this, Biovel is working on the sustained delivery cough syrup formulation, which could lead to a patent and the company is taking up several other projects like erythropoietin, interferon, and pegylated GCSF, which are at the early stage of research. Biovel is also developing a department which has the major focus on the delivery systems, either by inventing or by using the expired patents. Further, the company is entering in the areas of peptides and monoclonal antibodies in the coming years. Looking ahead More companies will be tempted to set up their R&D centers in India, and thus benefit from the advantages that India has to offer. There are already many examples of R&D centers doing quality work over here. The Indian government has also been instrumental in helping the domestic players and the MNCs to set up such centers in India, and is helping them with tax exemptions and other incentives. While other Asian countries are emerging as a major manufacturing hub for biotech products, India is heading towards becoming a global R&D hub for the life sciences industry. Many hope that this trend will continue, and that there will be a regular supply of skilled manpower. While it's still relatively early in the movement of R&D to India but with a focused and a long-term R&D vision, policy framework and commitment coupled with the incentives which the Indian government is offering, can go a long way in branding India as the R&D hub of the of the biotech world. Jahanara Parveen with inputs from Nayantara Som "The center will undertake farmer-oriented biotech research," New Page 2 "The center will undertake farmer-oriented biotech research," Dr M Ramasami, Managing Director, Rasi Seeds Give us an estimate of Rasi Seeds' recent and future investment programs? Rasi Seeds has invested around Rs 10 crore for the present R&D center and our future investments for biotechnology and crop research is expected to be around Rs 15 crore. What is the idea behind setting up this biotechnology research center at Attur? The center has the state-of-the-art biotechnology facilities established in rural area, and thus is one of the first of its kind. The center will undertake farmer-oriented biotech research and thus was established in an intensive agricultural area. What are some of the major changes witnessed in the Indian bioagri R&D? Agribiotech sector witnessed remarkable and successful adoption of insect-protected Bt cotton as the first biotech crop in India which is by far the largest adoption in the world on year to year basis. The transgenic technology was well adopted by the Indian seed industry, particularly for cotton that resulted in high yield of seed cotton to farmers, with increased income. Currently India enjoys the status of an exporter of cotton, from an importing country earlier. Thus considering the substantial benefits realized by farmers through biotech cotton, the adoption of biotechnology will be very useful for crop improvement of all the crops in the future. What are the growth areas and opportunities for R&D in India? The major areas would be development of transgenic food crops that reduces the losses in yield due to pests and diseases. The other area is complementation of biotech tools in crop breeding that will facilitate crop improvement, particularly for complex agronomic traits such as yield and quality of the crop. Further, diagnostics for the viral and fungal diseases is an important area by which suitable measures can be taken to protect the crop. Thus in order to infuse the biotechnology in agriculture, seed industry should be ushered for adoption and government should recognize the role of seed industry, as seed is the main carrier of technologies. Public and private agribiotech sectors should work together to address the challenging problems to meet the demand of the farmers and consumers. It is expected that government shall consider investing more on agribiotech research. Can you share some information on India's regulatory environment and its implications for R&D? The regulatory system has evolved well based on the experience of transgenic cotton. However, in order to encourage the agricultural sector to develop new transgenic food crops to meet the high demand for food and to increase crop productivity, the regulatory system should facilitate such research activity, but with full biosafety considerations. Can you outline how Rasi plans to leverage on the industry growth? Since the agribiotech sector is cost-intensive and technology-oriented we would seek the collaboration of mentor institutions in the country as well overseas, to adopt the best and viable technologies in crop improvement that will be beneficial to the farmers and consumers. Jahanara Parveen   ]]> <![CDATA[National Biotech Policy: One Year Later]]> https://biospectrumindia.com/news/95/5922/national-biotech-policy-one-year-later.html https://biospectrumindia.com/news/95/5922/national-biotech-policy-one-year-later.html Wed, 05 Nov 2008 11:17:00 +0530 New Page 1 National Biotech Policy: One Year Later A report on what all has been done towards the target areas of the policy and what is being worked upon ... Exactly a year ago, in November 2007, the much awaited National Biotechnology Development Strategy was approved by the Government of India after a two year-long nationwide consultation process with multiple stakeholders including ministries concerned, universities, research institutes, private sector, civil society, consumer groups, non-government and voluntary organizations and international bodies. The strategy laid a strong emphasis on discovery and innovation effectively utilizing novel technology platforms with the potential to contribute to long-term benefits in agriculture, animal productivity, human health, environmental security and sustainable industrial growth. Dr MK Bhan, secretary, DBT in an interview with BioSpectrum emphasized on developing the innovation potential through the strategy that fosters development in areas such as translational science, clinical and field research, product development, and R&D in the industry. "The purpose of the strategy is to head towards innovation and produce novel products, while capitalizing on the current opportunities in clinical research and biosimilars," he had said. A year later, we find out what all has been achieved in this quest and what is being worked upon. NBRA Proposed: The National Biotech Development strategy proposed the setting up of National Biotech Regulatory Authority, NBRA that would provide a single window clearance of genetically modified products and processes. It was in June 2004 that the Task Force on Application of Biotechnology in Agriculture, under the chairmanship of Dr MS Swaminathan, submitted its report recommending the setting up of a National Biotechnology Regulatory Authority (NBRA) for promotion and regulation of application of biotechnology in agriculture. After the inter-ministerial consultations on the recommendations of the MS Swaminathan Task Force report, the Department of Agriculture and Cooperation identified some areas for prioritized action and subsequently, the note for setting up the NBRA was mooted in the Cabinet by the Ministry of Agriculture. As per the draft bill, NBRA shall be responsible to regulate the research, manufacture, importation and use of genetically engineered organisms and products derived thereof. It may specify measures to regulate the importation of genetically engineered organisms into India; containment of genetically engineered organisms in India; clinical studies of genetically engineered organisms and derived medicines in India; environmental release of genetically engineered organisms in India; the use of genetically engineered organisms and products derived thereof as, or in, food and use in human or animal health, agriculture or other applications in India; and procedures and standards in relation to the accreditation and notification of facilities undertaking research with genetically engineered organisms. Current status: The draft of the NBRA formation was placed in public domain for suggestions from stakeholders and industry and is yet to be placed before the parliament. A number of consultations with farmers, lawyers and industry have been organized. DBT has received a huge number of comments and suggestions from direct meetings. Over 300 suggestions have been received through email too. So far, there were nine consultation meetings with various stakeholders about the biotech policy. Consultations with legal experts involving practicing lawyers from supreme court and high court, a meeting with state government officials, six with multiple stakeholders and one with print and electronic media were conducted following which the recommendations were compiled. A total of 600 people attended these consultations. After consultation with state governments, a document was created and sent to them again for their comments. Over 30 responses were received from these governments for DBT's consideration. DBT is now conducting inter-ministerial consultations regarding the presentation of the NBRA. BIRAC Proposed: The policy proposed the launch of the Biotechnology Industry Research Assistance Council( BIRAC) to stimulate, foster and enhance the innovation capabilities of small and medium enterprises. The main aim of BIRAC was to act as an interface between academic and private sector, particularly SMEs and start-ups; nurture and catalyze R&D and innovation in the private sector; promote public-private partnership Current status: As an interim measure, a pilot biotechnology industry R&D assistance program, has been approved by the government which would facilitate and promote industrial research through technology transfer and IP management, technology acquisition and technology forecasting. In addition there would be a special cell that would address the needs of training and capacity building. Its main functions would include: Logistics, services and support for public private partnership program including support for biotech parks and incubators, research resource facilities, IP management services etc. Industry platform programs Facilitating technology assessment and transfer Information, research, analysis and advisory services Building awareness of potential opportunities and capacities in areas which require skilled human resources   Biotechnology Industry Partnership Program (BIPP) Proposed: The policy laid down the formation of BIPP to generate IPR in advanced technology areas such as agriculture, health, environment, bioenergy and biomanufacturing. This is with an aim to enter the advanced technology area, when the potential is uncertain rather than when the potential is established. A novel feature of this cost sharing scheme is to allow the industry partner to retain intellectual property, with payment of appropriate royalty to the contributing public sector scientist. Current status: The program is awaiting cabinet approval currently. It would facilitate partnership with the industry for: Fulfilling major unmet national technology needs in health, agriculture, energy and environment friendly or green manufacturing area. Increasing global competitiveness of Indian industry in new and futuristic technology. Evaluation and validation of already available products of high national importance. It will also look at shared major facilities around platform technology as core facilities.   DBT Wellcome Trust scholarships Proposed: With the aim of encouraging R&D in the country and reversing brain drain, the policy had stressed on innovative reentry packages for senior scientists in terms of fellowships to attract them to the country and motivate them to pursue research on national priorities. Current status: DBT announced a jointly-funded Biomedical Research Career Program with Wellcome Trust UK to fund cutting-edge biomedical research in India in September this year. The partnership was announced by Dr MK Bhan, secretary, DBT and Dr Mark Walport, Director, Wellcome Trust. The £80m scheme, jointly funded by DBT and the Wellcome Trust over five years and aims to strengthen the research base of Indian biomedical science by providing fellowship programs to support researchers from newly-qualified postdocs through to senior researchers. The program will be delivered by the Wellcome Trust/DBT India Alliance, an independent, public charitable trust based in New Delhi and established by the two partners. Each year, the Alliance is expected to award around 40 early careers fellowships, 20 intermediate fellowships and 15 senior research fellowships. Shalini Gupta   ]]> <![CDATA[The Nobel Prize in Physiology or Medicine for 2008]]> https://biospectrumindia.com/news/95/5161/the-nobel-prize-in-physiology-or-medicine-for-2008.html https://biospectrumindia.com/news/95/5161/the-nobel-prize-in-physiology-or-medicine-for-2008.html Wed, 05 Nov 2008 11:12:00 +0530 New Page 1 The Nobel Prize in Physiology or Medicine for 2008 This year's Nobel Prize awards discoveries of two viruses causing severe human diseases. Harald zur Hausen went against current dogma and postulated that oncogenic human papilloma virus (HPV) caused cervical cancer, the second most common cancer among women. He realized that HPV-DNA could exist in a non-productive state in the tumours, and should be detectable by specific searches for viral DNA. He found HPV to be a heterogeneous family of viruses. Only some HPV types cause cancer. His discovery has led to characterization of the natural history of HPV infection, an understanding of mechanisms of HPV-induced carcinogenesis and the development of prophylactic vaccines against HPV acquisition. FranÃ§oise BarrÃ©-Sinoussi and Luc Montagnier discovered human immunodeficiency virus (HIV). Virus production was identified in lymphocytes from patients with enlarged lymph nodes in early stages of acquired immunodeficiency, and in blood from patients with late stage disease. They characterized this retrovirus as the first known human lentivirus based on its morphological, biochemical and immunological properties. HIV impaired the immune system because of massive virus replication and cell damage to lymphocytes. The discovery was one prerequisite for the current understanding of the biology of the disease and its antiretroviral treatment. Importance of the HPV discovery The global public health burden attributable to human papilloma viruses is considerable. More than 5% of all cancers worldwide are caused by persistent infection with this virus. Infection by the human papilloma virus is the most common sexually transmitted agent, afflicting 50-80% of the population. Of the more than 100 HPV types known, about 40 infect the genital tract, and 15 of these put women at high risk for cervical cancer. In addition, HPV is found in some vulval, penile, oral and other cancers. Human papilloma virus can be detected in 99.7% of women with histologically confirmed cervical cancer, affecting some 500,000 women per year. Harald zur Hausen demonstrated novel properties of HPV that have led to an understanding of mechanisms for papilloma virus-induced carcinogenesis and the predisposing factors for viral persistence and cellular transformation. He made HPV16 and 18 available to the scientific community. Vaccines were ultimately developed that provide ≥95 % protection from infection by the high risk HPV16 and 18 types. The vaccines may also reduce the need for surgery and the global burden of cervical cancer. Importance of the HIV discovery Soon after the discovery of the virus, several groups contributed to the definitive demonstration of HIV as the cause of acquired human immunodeficiency syndrome (AIDS). BarrÃ©-Sinoussi and Montagnier's discovery made rapid cloning of the HIV-1 genome possible. This has allowed identification of important details in its replication cycle and how the virus interacts with its host. Furthermore, it led to development of methods to diagnose infected patients and to screen blood products, which has limited the spread of the pandemic. The unprecedented development of several classes of new antiviral drugs is also a result of knowledge of the details of the viral replication cycle. The combination of prevention and treatment has substantially decreased spread of the disease and dramatically increased life expectancy among treated patients. The cloning of HIV enabled studies of its origin and evolution. The virus was probably passed to humans from chimpanzees in West Africa early in the 20th century, but it is still unclear why the epidemic spread so dramatically from 1970 and onwards. Identification of virus-host interactions has provided information on how HIV evades the host's immune system by impairing lymphocyte function, by constantly changing and by hiding its genome in the host lymphocyte DNA, making its eradication in the infected host difficult even after long-term antiviral treatment. Extensive knowledge about these unique viral host interactions has, however, generated results that can provide ideas for future vaccine development as well as for therapeutic approaches targeting viral latency. HIV has generated a novel pandemic. Never before has science and medicine been so quick to discover, identify the origin and provide treatment for a new disease entity. Successful anti-retroviral therapy results in life expectancies for persons with HIV infection now reaching levels similar to those of uninfected people. Source: www.nobelprize.org ]]> <![CDATA[Glowing protein researchers win Nobel Prize]]> https://biospectrumindia.com/news/95/1944/glowing-protein-researchers-win-nobel-prize.html https://biospectrumindia.com/news/95/1944/glowing-protein-researchers-win-nobel-prize.html Wed, 05 Nov 2008 11:03:00 +0530 New Page 1 Glowing protein researchers win Nobel Prize The Royal Swedish Academy of Sciences has decided to award the Nobel Prize in Chemistry for 2008 jointly to Osamu Shimomura, Marine Biological Laboratory (MBL), Woods Hole, MA, USA and Boston University Medical School, MA, USA; Martin Chalfie, Columbia University, New York, NY, USA; and Roger Y Tsien, Howard Hughes Medical Institute, University of California, San Diego, La Jolla, CA, USA "for the discovery and development of the green fluorescent protein, GFP". Glowing proteins is considered as a guiding star for biochemistry. The brightly glowing green fluorescent protein, GFP, was first observed in the jellyfish, Aequorea victoria in 1962. Since then, this protein has become one of the most important tools used in contemporary bioscience. With the aid of GFP, researchers have developed ways to watch processes that were previously invisible, such as the development of nerve cells in the brain or how cancer cells spread. This year's Nobel Prize in Chemistry rewards the initial discovery of GFP and a series of important developments which have led to its use as a tagging tool in bioscience. By using DNA technology, researchers can now connect GFP to other interesting, but otherwise invisible, proteins. This glowing marker allows them to watch the movements, positions and interactions of the tagged proteins. Researchers can also follow the fate of various cells with the help of GFP: nerve cell damage during Alzheimer's disease or how insulin-producing beta cells are created in the pancreas of a growing embryo. In one spectacular experiment, researchers succeeded in tagging different nerve cells in the brain of a mouse with a kaleidoscope of colors. The story behind the discovery of GFP is one with the three Nobel Prize Laureates in the leading roles: Osamu Shimomura first isolated GFP from the jellyfish Aequorea victoria, which drifts with the currents off the west coast of North America. He discovered that this protein glowed bright green under ultraviolet light. Martin Chalfie demonstrated the value of GFP as a luminous genetic tag for various biological phenomena. In one of his first experiments, he colored six individual cells in the transparent roundworm Caenorhabditis elegans with the aid of GFP. Roger Y Tsien contributed to our general understanding of how GFP fluoresces. He also extended the color palette beyond green allowing researchers to give various proteins and cells different colors. This enables scientists to follow several different biological processes at the same time.   How the Jellyfish's Green Light Revolutionized Bioscience In the 1960s, when the Japanese scientist Osamu Shimomura began to study the bioluminescent jellyfish Aequorea victoria, he had no idea what a scientific revolution it would lead to. Thirty years later, Martin Chalfie used the jellyfish's green fluorescent protein to help him study life's smallest building block, the cell. Today, scientists are able to study biological processes that were previously invisible with the aid of Roger Y. Tsien's proteins, which glow in all colors of the rainbow. This year's Nobel Prize in Chemistry rewards a similar effect on science. The green fluorescent protein, GFP, has functioned in the past decade as a guiding star for biochemists, biologists, medical scientists and other researchers. The strong green color of this protein appears under blue and ultraviolet light. It can, for example, illuminate growing cancer tumors; show the development of Alzheimer's disease in the brain or the growth of pathogenic bacteria. An even more interesting use of GFP means that researchers can actually follow processes inside individual cells. The body consists of billions of cells, from pumping heart muscle cells and insulin-producing beta cells to macrophages that destroy unwelcome bacteria. The more researchers know about a cell type â€“ how it develops and functions â€“ the greater the chance that they can develop effective drugs with minimal side-effects. When researchers understand how cells start building new blood vessels, for example, they might be able to stop cancer tumors from acquiring a nourishing and oxygenating vessel system. There are tens of thousands of different proteins, each with different functions. By connecting GFP to one of these proteins, researchers can obtain vital information. They can see which cells a particular protein inhabits; they can follow its movements and watch its interactions with other proteins. Thanks to GFP's green light, scientists can now track a single protein under the microscope. ]]> <![CDATA[WHO's 5-month booster shot for vaccine makers]]> https://biospectrumindia.com/news/95/1721/whos-5-month-booster-shot-for-vaccine-makers.html https://biospectrumindia.com/news/95/1721/whos-5-month-booster-shot-for-vaccine-makers.html Wed, 05 Nov 2008 10:59:00 +0530 New Page 1 WHO's 5-month booster shot for vaccine makers DCGI gets time till March 31 to upgrade regulator's labs The World Health Organization (WHO) has given the Drugs Controller General of India (DCGI) five more months to improve its performance in accordance with international standards. The previous deadline of October-end was extended after a visiting WHO team was satisfied with the Indian drug regulator's modernization programs. The Indian vaccine makers were affected with WHO's decision as new products were not considered for WHO and UNICEF supplies due to inadequacies in the operational systems of the drug regulator since January 2008. The WHO approval is necessary for all international purchases and as UNICEF and WHO do not have their own testing facilities, they entrust the local governments to have a certified lab to meet the requirements. Unfortunately as the government laboratories on which the Indian regulator, the Drug Controller General of India (DCGI), relied were shut down over quality issues. The three undertakings that were shut down are Central Research Institute, Kasauli; Pasteur Institute of India, Coonoor; and BCG Laboratory (King's Institute), Chennai. The National Regulatory Agency (NRA--the combination of the Drug Controller General of India, Ministry of Health, and the three government units where drug tests are done) was being questioned by the WHO and other health agencies on several issues like modernization, the functioning of the NRA, surveillance methods, and the general licensing policy. This led to a dangerous situation where approvals to a dozen new vaccines made by Indian companies, known for their quality and reliability, were put on hold in the last 12-18 months. The situation was getting out of control as it was posing a major threat to the very existence of Indian companies due to the slow progress being made on addressing the issues raised by the WHO and other health agencies. The vaccines manufacturers were calling for speedy action to save the industry. Major leaders from the industry got together to find solutions and save the nation's vaccine industry. BioSpectrum organized a special meeting in Mumbai on August 28 to discuss the issues and highlight the measures that need to be taken on a priority basis. The Indian government agencies agreed to an inspection by a Canadian team to guide them and lay down the rules which they must follow. It was agreed that if WHO was satisfied after this, it will temporarily lift the ban on Indian agencies. The regulator has recommended to the Ministry of Health to set up new GMP (Good Manufacturing Practices) compliant, global standards manufacturing plants urgently to resume production of vaccines in the government sector in the country. During a media interaction the Drug Controller General of India, Dr Surinder Singh, in Mumbai in mid-September, said that they have submitted a report to the Ministry of Health on this issue and it has concluded that the three facilities--Central Research Institute, Kasauli; Pasteur Institute if India, Coonoor; and BCG Laboratory (King's Institute), Chennai--did not follow GMP and they cannot be modernized and made GMP compliant because they are very old institutions. Some of these institutions were set up over 100 years ago. The regulatory agency was working on improving the regulatory system by collaborating with the WHO for training activities and with the USFDA and Health Canada for other aspects. Vaccine manufacturers can now submit their revamp plans electronically. It was also introducing various e-Governance measures to bring reliability, accountability and adherence to timelines. The vaccine industry getting a breather for another five months is a good news and the industry should now use this interim period to get together and work closely with the government and all concerned to speedily address the concerns raised by the UNICEF and WHO and raise the credibility bar. ]]> <![CDATA[Investing in biofuels to create a sustainable and competitive industry]]> https://biospectrumindia.com/news/95/2617/investing-in-biofuels-to-create-a-sustainable-and-competitive-industry.html https://biospectrumindia.com/news/95/2617/investing-in-biofuels-to-create-a-sustainable-and-competitive-industry.html Wed, 22 Oct 2008 10:35:00 +0530 New Page 1 Investing in biofuels to create a sustainable and competitive industry Over the last two years, global venture capital firms have invested over $700 million into the biofuels sector. However, India needs to catch up. Rajeev Mantri is Executive director of Navam Capital. Billionaire investor and financier George Soros wrote a book called The Alchemy of Finance, widely regarded as one of the best books ever written on financial markets and investing. Today, a new breed of investors worldwide is betting big on the finance of alchemy. Riding high on the wave of innovation is a group that has been collectively christened "cleantech" that includes advances in materials science and chemistry of energy production, energy efficiency and environment management. Recent entry into this brigade is biofuels. Over the last two years, global venture capital (VC) firms have invested over $3.7 billion into this fast-growing sector, out of which over $700 million has gone into the biofuels sector. In India, however, biofuels companies are largely funded via the commercial banks through project finance route, in the form of debt capital. The biofuels industry, along with the broader cleantech sector, is at an embryonic stage in India. Globally, the model for funding biofuels companies has been through the private equity and venture capital route. Such firms contribute not just equity capital and financial capital to the venture, but also intellectual capital in the form of knowledge, expertise, know-how's and best practices. VC firms are able to supply social capital and human capital, leveraging their network to develop the business and also establish relationships with large companies, thereby recruiting key advisors and senior management. Moreover, it makes sense to fund biofuels companies through the VC route given the risk inherent in the venture. While banks tend to focus on protecting its principal, VCs with their greater risk appetite do not shy away from implementing innovative ideas and strategies. Given their equity stake, VC investors are partners in the growth of the business, and unlike bankers, will not take away the proverbial umbrella when the rain starts to pour. Clearly, the deployment of private capital is imperative for the development, competitiveness and sustainability of the biofuels industry. Biofuels and the larger cleantech sector stand where the telecom industry did in 1998. There is a need to attract innovators and entrepreneurs to the sector along with equity investors. Global nonprofit organization The Indus Entrepreneurs (TiE) has joined hands with leading venture capital firms and innovators to form localized special interest groups in cities all over India. Moreover, IIT Bombay in its Eureka! 2008 business plan competition has kept a special focus on cleantech and biofuels. Such initiatives nurture innovation, enable information flow and create a knowledge base. India has limited competency in inventing clean technologies, but our country holds tremendous potential for deploying technologies in biofuels and other cleantech areas. The size of our economy and geography warrant very large investments in energy and waste management. There is a lot of money to be made for entrepreneurs and innovators, who can identify the appropriate technology and adapt it according to India's needs. However, we need to get our priorities right. While the US has invested hundreds of millions of dollars in developing alternative fuels in response to the global oil crisis, we have been straining under the burden of subsidies and price controls, which distort market prices and stifle innovation. The government has an important role to play in facilitating policies. The recent proposal to have dual pricing for diesel consumption in the industrial and automotive sectors somewhat rationalizes a bizarre fuel pricing policy. The recent policy mandating 20 percent ethanol-blended petrol by 2017 is a significant step forward, and it's now up to the entrepreneurs to meet the demand.     ]]> <![CDATA[Fueling the future]]> https://biospectrumindia.com/news/95/5150/fueling-the-future.html https://biospectrumindia.com/news/95/5150/fueling-the-future.html Tue, 14 Oct 2008 15:08:00 +0530 New Page 1 Fueling the future In the last few weeks, the nation's attention has been riveted on securing its future energy sources. Two major forms of energy were in the news. First, the landmark decision of the 45-member Nuclear Suppliers Group and deals with the US and France, which will pave the way for India to tap the nuclear energy in a big way in the coming decades. Second, the country's largest private company, Reliance Industries, joined the party by announcing a major crude oil find in the eastern coast which will eventually provide over 40 percent of the nation's current conventional petroleum product demand. When these two major fuel sectors were making headlines, the biotech segment too decided to add its share to the nation's energy kitty. On September 11, the country got its first ever Biofuel Policy which seeks to convert at least a major part of the 60 million hectares of wastelands into farmlands for oil-bearing crops which can produce biodiesel in plenty. The government had started the biofuel initiative in 2003 and five years later, the nation finally got a policy framework. There is no doubt that the Biofuel policy will give further boost to the existing efforts by the private and public sector institutions to ensure the nation's energy security. The Biofuel policy has set an ambitious target of 20 percent blended biodiesel by 2017. This means a production of 15-16 million tons of biodiesel and a coverage area of over 30 million acres of biofuel plantation. Though the policy has been announced only this September, companies have made significant investments in the biofuels arena after the announcement of biofuels mission in 2005. Some of the companies have just started the commercial production of biodiesel and several others are likely to start in the next two-three years. The investments which have gone into biofuels plantation and production are in excess of Rs 1,000 crore and the industry expects the biofuels to rake in $25 billion in revenues by 2017. This is not an unachievable target provided there is clear focus on the feedstock cultivation and a political will to implement the same. While biofuels is one of the biotech ways to address the "save the planet Earth" initiatives, there are other ways of addressing it through biotechnology. For example, use of enzymes can play a major role in saving earth as they find applications in almost all industrial applications. According to a few reports, the use of enzymes in several industrial products is abysmally poor. There can be favorable guidelines to promote use of enzyme technology and probably an enzyme policy, on the lines of the Biofuel policy or the Biotech policy for recombinant drugs, needs to formulated quickly. In the next few months BioSpectrum will take up the case for "green initiatives" and bring out white papers that can be relevant and important to India and from an Indian context too. Another major focus area of the government should be health. The Union Budget had announced 15 percent increase in allocation for healthcare spending. It was a good decision however there has been little progress made by the health ministry for addressing serious issues. Take for example immunization. India has one of the lowest routine immunization rates in the world. Some estimates indicate that only 40-45 percent of children in the age group of 12-24 months are fully vaccinated (BCG, measles, and 3 doses of DPT and polio vaccines). National-level immunization programs are an important way for population protection. While Indian manufacturers are among the largest suppliers of quality vaccines to UNICEF, they are not recognized by our own national government and their concerns not addressed promptly by the policy makers. The industry is almost on the death bed. No new vaccine was launched by any Indian company in the last 12 months because of WHO's stand on strengthening the Indian regulator. Things seem to be improving but almost at a snail's pace. The government should rise and act fast to save our children and also our companies. India certainly is the cynosure of the world's eye now in the genomics space. The Human Genome Organization (HUGO) held its annual Human Genome Meeting (HGM) in Hyderabad from Sep 27-30 2008. The field of genomics has seen some rapid progress in the last few years in India too. The Indian genes have been mapped and now we are moving towards open source drug discovery. About Rs 500 crore will be allocated for this. This is good for the industry and society. Wish you a happy festival season. <sureshn@cybermedia.co.in>   ]]> <![CDATA["Materials management in biotech R&D can be more effective,"]]> https://biospectrumindia.com/news/95/2087/materials-management-in-biotech-rd-can-be-more-effective.html https://biospectrumindia.com/news/95/2087/materials-management-in-biotech-rd-can-be-more-effective.html Tue, 14 Oct 2008 15:03:00 +0530 New Page 1 "Materials management in biotech R&D can be more effective," -Dr S Roychowdhury, head of the materials department, National Centre for Cell Science, Pune Dr S Roychowdhury is working with National Centre for Cell Science (NCCS), Pune, as the head of the materials department since 1994. He has written a thesis on "a comparative study of materials management practices in select biotech organizations under the Ministry of Science & Technology (GoI)". He shares with us some of the findings of the study. What were the key objectives of the research in this area? We found out that research institutes today can be more effective with regard to providing enabling environment for the researchers through provision of adequate and timely supply of materials. This is important for carrying out meaningful scientific research as well as meeting the targets set for completion of various in house and sponsored projects in labs and institutions. There is a considerable loss in total procurement by the institutes, especially with perishable consignments due to fulfillment of the import formalities with various authorities like Customs, Drug Controller, Quarentine, Warehouses (under the control of international Airport Authorities), and banks. Besides that, poor handling of the material in the airport as well as at the institute, miscellaneous factors like P&F, transportation, purchasing cost, and wastage due to non-utilization of reagents prior to its expiry date and un-systematic preservation of chemicals in laboratory also affect the institutes. In addition, failure of electricity, power fluctuations as well as non-availability of UPS contribute to the losses. These can be avoided and considerably reduced by trained and professional logistic manpower, planned and scheduled procurement methodology and modern preservation system and anlaysis respectively. How can better knowledge of material management help the research fraternity? Material management helps in reducing material costs, preventing large amount of money being locked up for a long period or wasted especially in biotech sector where most of the materials are perishable items. About 90 percent of the total requirement of material in biotechnology R&D organizations is from countries around the globe, which requires an effective and good system for the procurement of materials. Besides, storage being an essential part of the economic cycle, stores management becomes a specialized function, which can contribute significantly to the overall efficiency and cost effectiveness. Sophisticated laboratory equipment, reagents and chemicals of highly perishable nature like restriction enzymes, antibodies, media, sera and other consumables are required to be procured and handled in such a way that cost can be effectively reduced. What steps need to be taken to ensure effective materials management in R&D institutes? We need to establish and formulate a systematic procedure for procurement of different kind of materials useful for R&D organizations in general and biotech R&D organizations in particular. A rationalized manual or guidelines could be prepared for all the R&D biotech organizations in India that can serve as a portal to enter this vast area and draw attention to basic norms and practices governing public procurement. A guideline will be immensely helpful to establish transparency, competition, and fairness to eliminate arbitrary public buying. There has to be an exchange of ideas between biotech organizations in this direction and to find a suitable solution for avoiding discrepancies in material handling, proper way of preservation of special type of items, which are classified according to the nature of the usage. Notification for customs can be drawn separately for the biotech institutes under the Government of India. This will require a better understanding and discussions with different authorities under the jurisdictions of the respective ministries. Shalini Gupta   ]]> <![CDATA[Thermo's integrative technologies offerings]]> https://biospectrumindia.com/news/95/2572/thermos-integrative-technologies-offerings.html https://biospectrumindia.com/news/95/2572/thermos-integrative-technologies-offerings.html Tue, 14 Oct 2008 14:53:00 +0530 New Page 1 Thermo's integrative technologies offerings "Our thrust is on biologics, niche solutions, and systems integration," -Himat (Kim) Shah, director of marketing and business development for the informatics business, Thermo Fisher Scientific. Himat (Kim) Shah is director of marketing and business development for the informatics business of Thermo Fisher Scientific. In this role, he is primarily responsible for guiding the business' strategic product direction, building and maintaining the business' role as a leader in laboratory informatics, developing and building strategic relationships with other solution partners, and directing day-to-day marketing activities in support of it sales teams. Shah shares the strategies. Can you tell us bout the informatics business of Thermo? Informatics is part of integrative technologies division of Thermo. Life sciences is one of the biggest markets that this group serves and nearly accounts for 60 percent share of the total business of the integrative technologies' division. The other important markets being served are oil and gas, chemicals, and food safety. What are the three major thrust areas for the informatics group, more so from an India perspective? The thrust would be in the areas of biologics, specific-solutions for CROs, and as a turnkey provider and a systems integrator. Biologics: The pharma and biotech are all important industries for Thermo Fisher. We have a portfolio which includes SampleManager LIMS, an enterprise solution used in laboratories; Watson LIMS, for pharmaceutical bioanalytical laboratories; Galileo LIMS, designed specifically for ADME and in-vitro testing; Nautilus LIMS, used in a range of industrial applications and increasingly by biotechnology laboratories because of its configurability, patented workflows and plate-handling capabilities; and Darwin LIMS for pharmaceutical manufacturing R&D and QA/QC. In addition, we market the Atlas CDS, a multi-industry enterprise-class system integrated with our LIMS solutions for greater accuracy and consistent reporting of shared data, as well as increased productivity. Integrative Technologies Thermo Fisher Scientific, with over $10 billion in revenues, is a leader in serving science. The foundations of the company are its two premier brands-Thermo Scientific and Fisher Scientific. It has two distinct business segments. One is Analytical Technologies Segment (ATS) and the other being Laboratory Products and Services Segment (LPSS). The ATS' growth platforms include analytical instruments, specialty diagnostics, and biosciences. LSS caters to providing customers easy access to routine laboratory products and services. ATS has seven principal product groupings-Scientific Instruments, Biosciences, Microbiology, Integrative Technologies, Diagnostics, Environmental Instruments and Process Instruments. And Integrative Technologies' offerings include software interpretation tools and development support for the data generated by the instruments as well as laboratory automation equipment and systems. Custom solutions: CROs in India have integrated set-ups in a single multi-storey building and the number of CROs is on a rapid rise. CROs are all buying Watson, a FDA validated product, for their BA/BE studies. Almost 49 of the top 50 CROs have standardized on Watson. Watson is perfect for the BA studies but it does not have many of the other features that the CRO labs need. For example, the CROs set-ups in India since they are integrated need software for tracking patient registrations, contamination, and managing several other issues; they need software for protocol, clinic data management, resource scheduling, chemical sourcing, etc. So to offer comprehensive software tailor-made to suit these needs we are partnering with a local company in India for clinic management, etc. This is one of our areas of concentration. End-to-end solutions and services: Today there may be about 60 CROs for BA studies. We think that this number would go up to 200 in the next few years. That means new virgin sites would have to be built. And Thermo Fischer as a corporation has everything that one of these labs needs, starting from a group of people who can design the lab and build the lab physically to instrumentation, validation, software integration, training, and all the consumable from Fischer. We can do a complete turnkey project. But we hadn't thought like that earlier. And we have started thinking in that direction. Basically we would like the lab to give the output specs and we can build, furnish, and have a working lab without any headaches. We would be something like a systems integrator and the lab need not buy products from Thermo alone.   ]]> <![CDATA["India seems primed and ready for a biotechnology growth phase"]]> https://biospectrumindia.com/news/95/2862/india-seems-primed-and-ready-for-a-biotechnology-growth-phase.html https://biospectrumindia.com/news/95/2862/india-seems-primed-and-ready-for-a-biotechnology-growth-phase.html Tue, 14 Oct 2008 14:49:00 +0530 New Page 1 "India seems primed and ready for a biotechnology growth phase" -Susan Riley, director of international business development, Sigma-Aldrich Leading life science and technology company Sigma-Aldrich recently announced a partnership with India-based Metahelix Life Sciences, an agricultural biotechnology company focused on developing traits and technologies for crop protection and improved productivity. This partnership will bolster the range of applications for Sigma-Aldrich's plant bioscience products in South East Asia. Under the terms of the agreement, Metahelix will assist in developing applications data for Sigma-Aldrich's plant bioscience product line at the Sigma-Aldrich Center for Plant Bioscience, which will be housed at Metahelix's facility in Bangalore, India. In conversation with Susan Riley, director of international business development at Sigma-Aldrich, we find out more about the company's plans ... What are the various products offered by Sigma Aldrich for the biotech industry? What have been the most revenue grossing products worldwide? Our research biotech business unit supports life science researchers in pharmaceutical, biotechnology, academic, clinical research and government institutions. We provide high-value and innovative tools, solutions and services that enable scientists worldwide to do their work in every phase of the life science workflow. Some of the Primary products include: gene silencing technology, DNA extraction/amplification tools, knowledge-based research tools, protein purification tools and highly characterized human antibodies How big is your global biotech business and how much of it is derived from the Asia-Pacific region? Global sales for Biotech in 2007 were $299 million and we are on target to exceed growth goals of 10 percent while the market grows at only 4-5 percent. Our CAPLA region, of which India is a part, has been growing at more than twice those rates. How do you see the life sciences market in India as compared to the more developed markets? We currently see the biotechnology sector in India as fairly nascent but certainly recognize the growth potential. There is a continuum of life science research and in that hierarchy India seems primed and ready for a biotechnology growth phase. This is one of the reasons we have focused so much on infrastructure in India, making sure we had industry leading service levels (which requires superior logistics) and qualified local personnel to support the increasingly sophisticated customer base. When was the manufacturing facility set up in India and how has your business grown since then? The Bangalore SIAL facility was completed in August of 2006 and this facility has contributed significantly to our growth in the region. It is a state-of the art facility and one that both our employees and customers can be proud of. And we are already considering an expansion. You recently partnered with Metahelix Life Sciences for developing applications data for Sigma-Aldrich's plant bioscience product line. As these and other faster-growing markets develop, we plan to continue to leverage our global reach and establish partnerships with companies that complement our business model and provide the support needed for the developing markets. Metahelix is an example of a company that has expertise in an area we have interest in, does not compete with our business model, and was willing to provide the support we desired. And if a company like Metahelix can benefit in the process by having access to the latest technology and support, it makes sense for all. Are you looking forward to any future investment in the country? At this point Metahelix is a prototype relationship for us but if such partnerships continue to add value we would be very motivated to see additional partnerships in India or any of the developing markets. The key to this successful relationship is indeed the specialized nature of the Metahelix team. How many sales centers does the company have in India? We have 10 sales offices in India, four customs-bonded warehouses, four administrative offices, and one manufacturing facility. Our growth plan for this infrastructure is proportional to the growth in the Indian market and we continue to make future oriented investments. Shalini Gupta   ]]> <![CDATA["Our primary aim lies in enhancing our scope in drug discovery"]]> https://biospectrumindia.com/news/95/2096/our-primary-aim-lies-in-enhancing-our-scope-in-drug-discovery.html https://biospectrumindia.com/news/95/2096/our-primary-aim-lies-in-enhancing-our-scope-in-drug-discovery.html Tue, 14 Oct 2008 14:48:00 +0530 New Page 1 "Our primary aim lies in enhancing our scope in drug discovery" - Ram Sharma, managing director, BD India Becton Dickinson (BD) in collaboration with NCBS is setting up a center of excellence for flow cytometry. The collaboration is designed to develop and organize workshops, seminars and training programs on flow cytometric applications for basic and clinical researchers. Ram Sharma, MD, BD India, shares more light on this initiative. Why are you setting up the center? We believe flow cytometry is a relatively niche application and it needs to become mainstream. The question was how to make flow cytometry a mainstream application so that the scientists and life science research institutions harness the power of this application. We considered working with a premier research institution like NCBS to showcase the technology and provide hands-on training. We wanted to establish a center that would provide the researchers an opportunity to play with this technology and solve their problems, thereby, improving their solutions. A lot of researchers need some training on using the machines and NCBS, which has been in this stream for a long time, has experts who can train the researchers to use the machine the right way to find the right answers. With this center, they can make use of the technology to its full extent. Flow cytometry is all about cell analysis. Scientists want to know what exactly is happening inside a cell, hence research begins there. Unless you take a good look at the cell, you won't know the progression of a disease or how a drug is interacting in a cell. What prompted BD to set up this center? The first reason is that we own this technology. It is a 20-year old technology, which was co-developed by Stanford University and us. We feel that this technology has the capability to deliver real good solutions. Some 15 years ago, we never imagined that flow cytometry will become core for monitoring CD4. This is now the most preferred solution for monitoring HIV/AIDS patients. Almost 90 percent of all CD4 monitoring is done using our flow cytometry. Moreover, though the technology already has a lot of clinical applications like for cancer, HIV, cord blood banking, and stem cells, it has not been intensely deployed in the areas of drug discovery, life science research and basic research. With this partnership with NCBS, we can increase the scope of our products in the life science research applications. Our primary aim lies in enhancing our scope in drug discovery. This a very focused center on flow cytometry. The major difference between India and other countries is that they are very much specialized and they look at some verticals and excel in those verticals, while in India we want to do something general in biotechnology. This center is therefore a very focused one, meant only for flow cytometry. Can you elaborate on the investments? All our investments are long-term. This is a joint collaboration between NCBS and BD and both of us are investing in the center. While we take care of training and education, they take care of some expertise. However, we have offered our technology at a significantly subsidized cost, thereby considerably reducing their costs. Has the research community in India latched on to this technology? Our business is doing very well. We started our business around 1984 through a distributor and had about a dozen placements till 1996, when BD started its own operation in India. We have placed some 350 flow cytometry systems in both clinical and research so far. Who are you competitors in this space? There are several global companies like Beckman Coulter, Guava Technologies and Dako offering such products in India, but BD is the clear leader. Over a period of time, the technology becomes less competitive. The real difference is the quality of people who are training and educating the customers and the support that you provide to your customers. We also have to keep a constant check on the efficiency of the systems and probability of new applications for investment. Jahanara Parveen   ]]> <![CDATA[National Human Resource Life Science Forum]]> https://biospectrumindia.com/news/95/1420/national-human-resource-life-science-forum.html https://biospectrumindia.com/news/95/1420/national-human-resource-life-science-forum.html Tue, 14 Oct 2008 14:00:00 +0530 New Page 1 National Human Resource Life Science Forum HR professionals from life sciences team up to address HR issues Considering the astounding growth of the life sciences industry, a technological edge supported by knowledge workers has become a critical factor. HR professionals are responsible for developing a scientific and behavioral culture that improves an organization's capability for growth and development. Managing HR in a knowledge-based industry like the life sciences is a significant challenge as it involves a multi task responsibility. However, these points are not understood by most of the companies. Therefore to maintain the steady growth of the biotech industry, there is a need for a new kind of drive and excitement. The old HR system and structure shall not suffice. To address these issues, HR professionals from the life sciences have teamed up to form a National Human Resource Life Science Forum (NHRLSF). The forum is a representation of HR professionals from diverse life sciences organizations. HR professionals from leading life science organizations such as Advinus Therapeutics, Chembiotek, Dabur Pharma, Dr Reddy's Laboratories, DuPont India, GVK Biosciences, Jubilant Biosys, Matrix Laboratories, Orchid Chemicals & Pharmaceuticals, Quintiles Research (India), Sai Advantium Pharma, Syngene International and Veeda Clinical Research-India came together to take this initial step. George Selvam a senior HR professional and a management consultant facilitated the formation of this group. "This is a very significant and important initiative from the industry's perspective because it is for the first time that HR professional from the pharma, biotech and CRO have come together at one place. We are seeking active participation from the industry for this forum," said Thomas Putti, head (HR), Advinus Therapeutics and founder president of NHRLSF. The NHRLSF is formed with the basic objective of encouraging the HR professionals of this industry space to freely share their best and next practices in the HR forte. This has been done keeping in mind the exponential growth and change that this industry is going through not only in India or Asia but also globally. Additionally, NHRLSF will also focus in the areas of creating job opportunities, right talent development and CSR activities in the life science spectrum,. The forum has a well-defined scope under its formation and operation. Apart from providing a shared platform, there are initiatives for industry academic interface and recognition for organizations with best practices. The forum has also adopted certain cardinal principles, which influence its governance practices. It includes trust and transparency among the members, sustainability and growth of the forum, periodic review of scope, shared responsibility and decisions subject to audit. Membership to this forum is restricted to registered life sciences companies with minimum 50 full time employees. There is a formal process of application that needs to be proposed and seconded by existing members. An approved member organization is admitted on nominal fee. Human resources constitute an increasingly important and vital function in any life sciences company and biotechnology being a risky business the companies require managers and scientists with unique qualities. Dr Goutam Das, COO, Syngene pointed out, "Within the HR function there are a number of processes that can be made better and faster.Finding and solving these processes is part of the work, and measuring the impact of HR initiatives is crucial." HR is predominantly more of a service within a service, he added. The life sciences industry, which has been witnessing an impressive growth rate of more than 30 percent in the previous years, might face a break in its accelerated growth with an acute shortage of trained manpower. The current pool of scientific manpower engaged in the biotech industry, which is estimated to be 15,000, is expected to grow four fold to touch 60,000 by 2010. Therefore, there could be a huge gap between the industry's expectations and availability of quality manpower. "Life sciences has always played a secondary career path for the young generation. They prefer to choose other streams over biotech or life sciences. So there is a need to create an impact amongst the youth and thereby, attract a good human resource for this particular segment," pointed MA Mukund, director, HR, Quintiles Research (India). The objectives of the HR forum therefore shall primarily include-- professional fellowship among members, encouraging sharing of best practices, benchmarking compensation, industry and academia interface, represent to appropriate bodies (government, industry, educational etc), participate in relevant corporate social responsibility projects and create NHRLSF as an industry of choice for future career aspirants. PC Pandian, DGM HR, Jubilant Chemsys said, "We expect this forum to be of strategic importance to the industry and country. This would also be a common body to represent to the government authorities. Though this is a small beginning but we plan to expand it and make a global footprint and that is our ultimate vision." "Make India the destination for any career aspirant in life science sector," -Thomas Putti, Head HR, Advinus Therapeutics and founder president of NHRLSF What prompted the HR professionals from the life science community to set up this forum? The life science industry is in its inception stage in India with a huge growth potential. At this juncture every organization in this industry would go through the same challenges, possibly at different intervals of time. The HR Forum, an initiative by the HR professionals from the life science community, would avoid everyone from re-inventing the wheel as this serves as a platform for sharing their knowledge and experiences to help each other. What are the issues that this forum intends to address? The major objectives of the HR Forum shall include the following. However this is not limited. Instill professional fellowship among members. Encourage sharing of best practices. Represent the industry to appropriate governing bodies. Participate in relevant corporate and social responsibility project. Create life science as an industry of choice for the young career aspirants. What would be the forum's focus areas in the coming years? The forum was established in February 2008 and we are happy to have 13 organizations as members currently. The focus in the coming years is to give the forum the national presence and also to help the industry at large by attracting more talent. In the long run, we aspire to make India the destination for any career aspirant in the life science industry. How difficult is the management of human resources in the life sciences industry compared to the other industries? In any business, profit is the result of perfect product and services. Perfection in product and service is a result of robust processes. The successful implementation of processes depends upon the capabilities and attitude of the people. Hence, ultimately the people make the difference. More so in a cerebral industry--be it software development or life science research. Hence it is essential to appreciate, applaud and develop these talents in an organization. The biggest challenge is to get the people to converge to organizational systems on one hand while we encourage the divergent thinking in the business portfolio. Jahanara Praveen   ]]> <![CDATA['Asia to dominate adult stem cell commercialization']]> https://biospectrumindia.com/news/95/2790/asia-to-dominate-adult-stem-cell-commercialization.html https://biospectrumindia.com/news/95/2790/asia-to-dominate-adult-stem-cell-commercialization.html Tue, 14 Oct 2008 12:53:00 +0530 New Page 1 'Asia to dominate adult stem cell commercialization' -Don Margolis, Chairman & Founder, The Repair Stem Cell Institute, US How do you see the market for the commercialization of stem cells in the Asia Pacific region? There are significant factors that favor the Asia Pacific region over the West for the commercialization of stem cells. Western countries, particularly the US, have not only wasted billions of dollars but have squandered far too much time trying to prove that embryonic stem cells (ESC) can someday be safely implanted into humans. Science has taken a backseat as the issue has become embroiled in political and religious debates that have obscured the real issues. Tragically, adult stem cell (ASC) triumphs have been denied or covered-up in efforts to get the taxpayer to support embryonic stem cell research. Singapore learned the hard way that ESC simply don't work, but that truth has been kept away from the West. Led by China, India, and more recently Singapore, ESC research has been accepted for what it is-embryonic stem cells do not work when implanted into animals. APAC, wisely, focuses its research efforts on what does work. There are in excess of 100 diseases considered "untreatable" by Western medicine, which have been proven treatable with adult stem cells administered by APAC doctors. These treatments are not necessarily cures but over thousands of cases have improved the quality of life of the average patient using the implantation of either autologous ASCs (taken from the patient's own body) or by ASCs derived from cord blood. Just recently in America, a well-backed politically powerful group, using the excuse of overseas stem cell frauds, has started a strong effort to shove ASC into the trap of FDA drug company rules, which will surely destroy economically this infant science in North America and possibly Europe too. For these reasons, APAC has a chance to dominate ASC commercialization for decades to come. What are your views on the current status of the commercialization of stem cell research being conducted at various labs around the globe? Research in the West is forced to go down the path of drug regulation, which means it will be 10 years, if they are lucky, before the ASC successes can be commercialized. The leading American ASC company, Osiris, despite over five years of research within that restrictive structure, has not even applied for one ASC-implanting clinical trial! Forced to operate by investors and regulators as a "drug company," they are striving for "products", not for ASC implants. One American ASC heart company, Bioheart, is struggling to raise the funds for its well-proven therapy for common heart diseases, because they are forced to try to imitate what drug companies do to "come to market", that is spend $2 billion. Can it be done with a mere $50-100 million? Probably not, but they are trying. By comparison, TheraVitae went to the market with only $4 million in APAC and has successfully treated well over 300 heart patients to date-only because they chose APAC and not the West. In the entire "developed" world there is only one ASC treatment center, which has been subject to strict regulation and approved by the government. Therapies for diseases considered "incurable" and "untreatable" are not considered possible by the average doctor in the West, because they have been intentionally deprived of scientific information. Hard to believe? Consider this: Recently, three new scientific victories for ASC researchers have been announced, but the publications are not allowed to use the term "adult stem cells" in the articles. They must refer to them only as "stem cells," so that the public will think, as a majority has been trained to do, that it is embryonic stem cells that were being used. The bottom line is that there are few profits in stem cell research. The West may put them under a $2 billion, 15-year drug approval system, something that no stem cell company can possibly survive. Latin America was one of the first back in 2002, but they have neither the funds nor the drive of APAC. Europe also was a pioneer in 2001, but is now stuck in the embryonic and regulatory traps. Therefore, APAC will increase its stem cell commercialization lead every year into the foreseeable future.   ]]> <![CDATA[Stem Cells The Holy Grail]]> https://biospectrumindia.com/news/95/2384/stem-cells-the-holy-grail.html https://biospectrumindia.com/news/95/2384/stem-cells-the-holy-grail.html Tue, 14 Oct 2008 12:40:00 +0530 New Page 1 Stem Cells The Holy Grail Patients across the world are holding on to the tenuous thread of life by the hope stem cell therapy provides while the research itself is facing challenges of all kinds-scientific, political, legal and ethical. In this special report BioSpectrum captures what the business leaders are doing to commercialize the research and sustain until we reach the goalpost. Penetration of Stem Cell Therapy in APAC Region Singapore has the highest penetration for stem cell therapy, achieving almost 25% penetration rate by 2010. Both Thailand & Taiwan have similar penetration rates achieving overall penetration of almost 4% by 2010. Malaysia on the other hand has a relatively lower penetration rate at 1.2% by 2010. India offers penetration of 5% by 2010 largely accounted by stem cell therapies derived out of cord blood banking. It has three international players already creating a headstart. In the APAC regions, Singapore has the highest penetration with a CAGR of almost 66% for market penetration over the next five years. Malaysia leads second with a CAGR of 33%. Taiwan & Thailand lead on the basis of sheer numbers, but would have a comparatively lower demand trajectory due to restrictive healthcare policies. Source: Stempeutics   Narayan Kulkarni & Sanjeev Jain ]]> <![CDATA[New trends in cancer research and treatments]]> https://biospectrumindia.com/news/95/7713/new-trends-in-cancer-research-and-treatments.html https://biospectrumindia.com/news/95/7713/new-trends-in-cancer-research-and-treatments.html Tue, 14 Oct 2008 12:36:00 +0530 New Page 1 New trends in cancer research and treatments The gradual metamorphosis on the macro front has led to a three-dimensional change in cancer research and treatments especially in the area immunobiological treatments for cancer. The area of immunobiology in cancer is rather hot. Several monoclonal antibodies are currently in development against various targets and are undergoing clinical trials at this moment. The idea that tumor cells evade the immune system and that it might be possible to tweak the tumor cells to present themselves as foe to the immune system is a very exciting thought. The preliminary successes of the EGF-vaccine in increasing survival and the HER2 E75 breast cancer vaccine are indicative trends. Nevertheless, more data is still needed to bring these therapies on-board with conventional anti-tumor therapies," said Dr Arun Anand, MD, R&D, Biocon Ltd. On the other hand, in the field of research, companies across the world are looking at interesting targets that could fuel a shift in the way cancers get treated, including the targeted therapy using monoclonal antibodies. According to Dr Anand, "The identification of cancer stem cells throws in a whole new twist in the battle to cure cancer. Biomarkers and technologies that aim to identify and predict recurrence or a poorer prognosis, including the newly validated CTC chip to detect circulating tumor cells, or mutations in K-ras genes or VEGF expression that predict response to therapy or lack of it are likely to be incorporated in trials early to differentiate therapeutic efficacy." Apart from launching new products, companies are also looking at innovative drug delivery systems along with some technological innovations. A lot of emphasis has now come onto companion diagnostics to determine and identify effective responders as well as predictive biomarkers. This will help outline the population that might benefit the most from an active intervention. "While a targeted monoclonal antibody remains a hot target that most companies are pursuing, the large macro-molecular sizes prevent multiple modes of delivery. At best currently, MAbs can be delivered subcutaneously. Oral MAb delivery platforms are being worked upon and so are methods to design MAbs with reduced potential immunogenic responses to therapy," opined Biocon's Dr Anand. Biocon and Abraxis BioScience recently launched Abraxane the nanotechnology-based anticancer drug in India for the treatment of breast cancer, after failure of combination therapy for metastatic disease or relapse within six months of adjuvant chemotherapy. Abraxane is an important addition to Biocon's oncotherapeutics portfolio. Abraxis claims that the Phase III clinical trial of the product in the US showed Abraxane nearly doubling the response rate, significantly prolonging the time to progression, and improved overall survival in the second-line setting compared to solvent-based Taxol of Bristol-Myers Squibb in the approved indication. The oncotherapeutic product approved for use in breast cancer is currently undergoing advanced phase trials worldwide for other cancers. "Abraxane is the first nanotechnology-based anti-cancer drug that is administered as albumin-bound particles of approximately 130 nanometers and takes advantage of albumin, a natural protein that acts as the body's key transporter of nutrients and other water-insoluble molecules and accumulates in tumor tissues," said an Abraxis Bioscience spokesperson. Last year, Dabur Pharma, a leading manufacturer of anti-cancer drugs, had also launched nanoxel the novel drug delivery system for the widely used anti-cancer drug Paclitaxel. The nanoscale drug delivery system is claimed to be India's first indigenously developed nanotechnology-based chemotherapy agent. The anticancer drug, based on the principles of nanotechnology, is a cremophor free water-soluble formulation and is indicated as an effective and safe therapy for advanced breast, non-small-cell lung, and ovarian carcinomas. Dabur Pharma has an in-house capability to develop critical anti-cancer products as well as proprietary technologies that considerably accelerate the ongoing research and development work at its research facility. The company plans to rollout the chemotherapy drug delivery formulation internationally in the near future. Antigen-Specific Cancer Immunotherapeutics (ASCI) is a new type of immunotherapy developed by GSK aimed at treating cancer. It aims at treating cancer (in this case lung cancer) through the targeting of antigens that are selectively expressed by cancer cells but not (or at low levels) by normal cells. ASCI, which are investigational compounds, selectively target antigens that are expressed by cancer cells but not expressed by normal cells. These are called cancer-specific antigens. ASCI aims at triggering an immune response or enhancing the initial immune response to the patient's tumor. Even though the initial immune response may not be strong enough to remove the cancer, it has been shown to provide a basis for further immunization as treatment. Intas Biopharmaceuticals Ltd (IBPL) is focusing on developing Novel Drug Delivery System (NDDS) for proteins, a cloning facility, introducing production platforms and developing recombinant products (cytokines, hormones and blood factors). IBPL has constituted a dedicated strategic research team in order to develop technologies, new molecules related to biopharmaceuticals, and evaluate technology platforms. "IBPL is planning to generate clones for commercial production of protein using state-of-the-art technologies to improve yields, quality as well as adopting novel expression systems (including transgenics) with an objective to build intellectual property over the long run. IBPL, in a planned and phase-wise manner will screen technologies, new molecules and identify the most promising ones, prioritizing them on the basis of their business potential and compatibility," said Dr Rustom Mody, director (Quality & Research), Intas Biopharmaceuticals. IBPL will also develop NDDS for proteins for nasal and mucosal delivery as an alternative to the generic injectable formulations currently in use. This area has strong potential of generating IP in terms of patents AND publications and could provide a novel platform for delivery of many of the protein therapeutics. Actis Biologics' recent acquisition is based on Ligand Linker Drug Delivery (LLD) system and is claimed to be of tremendous value in reducing the toxicity of chemotherapeutic agents. Sanjeev Saxena, cofounder and chairman, Actis Biologics, said, "Liver and kidney cancer was something that Anjizoyme did not address and that is when Ligand happened which was developed by Dr Paul Tso at John Hopkins University." Moreover it is found that chemotherapy does not cure liver and kidney cancer. As of now the animal studies for this technology is complete and now the company intends to move to the next level. PN Venugopalan, president, Actis Biologics, added, "Within the next two years we should be able to launch Angiozyme if not globally but at least in South Asian countries and maybe in the matured markets." On similar lines, Panacea Biotec, which launched seven oncology products last year, is going one step further. The company feels that it would be able to launch novel drug delivery based anti-cancer drug in the next two-three years. "We plan to develop NDDS of the existing anti-cancer molecule. The new research-based drug development will take two-three years as we need to develop an effective distribution chain and occupy a significant market share in oncology drugs," said Rajesh Jain, joint managing director, Panacea Biotec. The future ORG IMS, in its annual forecast, has predicted that globally the growth of the oncology market will level out by 2012 due to various reasons. The foremost reason is seen as the tapering of current blockbusters. Introduction of newer blockbuster medicines will come down allegedly due to predictive biomarkers. Further, the expiry of four major blockbuster oncology drugs in the next five years will give way to a number of players in this same space. This will subsequently heat up the competition and intensify the price pressure. The market will also see a boom of biotech products in the segment. "Biotech products will dominate the scene along with personalized therapy. Target therapy, biomarkers, gene markers and both therapeutic and prophylactic vaccines would be the key to future anticancer treatment. Targeted therapy would ensure that drugs are safe. Though immunized antibodies are also targeted, they are limited by their own toxicity. Molecular stratification of the patient would lead to the designing of the drug in the future," said Dr Rama Mukherjee, former president, R&D, Dabur Pharma. "Indian oncology market is worth around Rs 800 crore," -Hitesh Sharma, Partner and National Leader Health Science practice at Ernst & Young. What are the present dynamics of the Indian oncology market? The size of the Indian oncology market is around Rs 800 crore. The therapies, which exist globally, also exist in India. Clearly the generic drugs are not that dominant in this segment because of its own set of challenges. Bulk of the products is mainly biotech, which again has its own set of challenges. Equally challenging is the investment that goes into the Indian companies which are trying to get to that level of comfort, because in biotech no two facilities can produce the same product. Apart from being an expensive process, it is a high-risk investment segment. So what should be the ideal business strategy? The strategy is more to identify the patients and see to it that they get the necessary treatment. Most companies look more at one-to-one doctor inputs and information. This segment is more doctor and hospital driven. So if you ask me, the only strategy that companies should adopt is to go beyond the strategy that they are presently following, i.e., going to tier-2 and tier-3 cities and widening their reach there. That again depends on the kind of facilities required by these kinds of ailments. Because it is a niche segment and you will have the same players continuing to invest and coming out with new products, that itself will be a boost to the market. As far as price is concerned, it is a debatable issue and there isn't any clear solution or answer for any company on the pricing structure. It will remain premium because we all know that the investment an Indian company puts in is quiet huge. What are the current research trends in cancer? There is a lot of research happening in the biosimilars space and India is actively participating in that space. This in a way contributes to the drug delivery systems. People are bullish about it because it saves a lot of R&D time and if it is a similar product and if you can show some efficacies in that then you do not need to show a whole host of clinical trails. What I understand is that the products are all in the development phase. How you see the oncology market emerging in the next three years? The market in the past three years has been growing at 25 percent and is amongst the top three segments in India. I do not expect it to slow down. You will see the arrival of a lot of biotech companies in this segment and that should only give an alternative to the Indian public. The debate on pharma turning to biotech continues because we have come to a stage where there are no life style diseases which do not have therapies and biotech gives a pharma company the additional space to operate. Do not be surprised because within a few years you will have some niche solutions rather than a medicine, which takes care of one particular therapy. Suck work will be happening in oncology and similar segments. While blockbusters might be there in the market for a few more years, upcoming niche solutions will cater to a few people, but will be more effective.   Nayantara Som   Nayantara Som with inputs from Jahanara Parveen (Bangalore) and Shalini Gupta (New Delhi)   ]]> <![CDATA[Anti-Cancer Market The Next Move]]> https://biospectrumindia.com/news/95/2822/anti-cancer-market-the-next-move.html https://biospectrumindia.com/news/95/2822/anti-cancer-market-the-next-move.html Tue, 14 Oct 2008 12:15:00 +0530 New Page 1 Anti-Cancer Market The Next Move With the anti-cancer market in India proving to be lucrative, several companies are now chalking out ambitious plans for the next level of growth in this sector. The landscape of the Indian biotechnology sector is going through a rapid metamorphosis for the better. Indian BioPharma companies, which account for around 70 percent of the total biotech market, are now revamping their business strategies wherein they are now looking beyond the traditional vanilla generics to the more niche therapeutic segments. Within this, oncology features among the top three segments zeroed upon as the preferred route of investment for most companies (which also includes most of the top10 companies). Attribute this to the intense competition or the soaring generic pricing. Companies have come to realize that focusing on a niche segment like oncology (both manufacturing and marketing) makes business sense to them and offers a wider reach to the market. The sharp rise in the incidences of the disease itself, especially in the urban and semi urban cities, furthers their case. A recent report by WHO has clearly mentioned that by 2020, the number of people with the disease will double in numbers. Going the niche way A recently published report from KPMG (India Pharma Inc--An Emerging Pharma Hub) points out that a niche segment requires a dedicated infrastructure. This is something, which only a few companies can afford and henceforth restricts the market to a handful of players. Competition is low and this further leads to lower price discounts, which leads to high profit generation. Mixed reactions prevail in the industry as far as the growth of the Indian oncology market is concerned. One school of thought maintains that there has been a slowdown in the market. A reliable source from the industry said that the oncology market in India constitutes just one-two percent of the total global market. The slow down is not in terms of the slow growth of the disease itself but in terms of the buying power of the masses and in terms of the supply chain. The other school of thought maintains that despite the slowdown, the market holds a lot of promise for companies in the future, especially the four major blockbusters going off patent. Moreover, in India oncology features among the top three segments. The latest ORG IMS' oncology report on the global market gives a balanced picture. It predicts that the global sales of cancer drugs will grow 12-5 percent and reach $75-80 billion in sales by 2012, nearly doubling the forecasted growth rate of the global pharmaceutical market (6.4 percent in 2007). While mentioning that there has been remarkable expansion over the last few years, and in spite of the predicted 12-15 percent growth, this industry feels like it is contracting not expanding. However this has not stopped Indian companies from tapping this segment. Be it in the form of partnerships and alliances that offer new platform technologies or in the upcoming innovative drug delivery systems for the market or even regulating their pricing structure to cater to the Indian market, India Inc has definitely got its wheels running! For instance, pharma major Ranbaxy entered into a marketing and distributing partnership with Hyderabad-based Zenotech Laboratories Ltd to work on two key areas, one of them being oncology. Gujarat-based Zydus Cadila has been focusing on anti-cancer drugs in particular wherein it has entered into a joint venture (50:50) with Mayne Pharma, Australia, for the manufacture of anti-cancer injectibles and APIs. MNC giant, Novartis India now offers its oncology product Glivec free of cost to around 9,700 patients in India and Asunara which globally costs around Rs 60,000 per course is given at Rs 4,000 per course. Leading biotech players like Biocon and Dabur are working on novel drug delivery systems for oncology. Amidst these there are a couple of companies working on the biosimilars too. Other majors include Dr Reddy's and GSK with the latter soon going to launch its much awaited anti-cancer vaccine Cervarix which has already been launched in the US and EU. Despite biotech being the next big approach to the oncology market, some prefer to remain in the domain of pharma for some more time. The reason cited is that biotech is an expensive and a time consuming process. The contention of industry experts both domestic and global pharma companies is that the biotech revolution which was supposed to witness its boom by 2010 has not really kicked off for myriad reasons. Agreed Ranjit Shahani, vice chairman and managing director, Novartis India, "Biotech as a field has a huge promise, but in many respects the potential has not been exploited. Five years ago it was said that by 2010, 25 percent of the pharma products would be biotech but that has not happened. It is a different ball game altogether." Oncology has been an important focus area for another leading pharma major Sun Pharma, which entered this market with independent marketing division five years back. Within two years of the launch of its product, Sun pharma was ranked among the top three oncology companies. Dilip Sanghavi, chairman and managing director, Sun Pharma, said, "Though the division contributes very little to the total sales of Sun Pharma in India, we have close to 4-5 percent share of the overall oncology market, despite we having less than 50 percent participation in the whole market. Our share from the market that we participate in will be about 9-10 percent. We have tapped the medical, radiation, hematological, neuro and surgical segments of oncology." The sales of this division have grown over six times in the last six years, at a CAGR of 45 percent. "Currently we do not have any biotech product. We have pharma products for almost all cancers covering breast, cervix, ovary, head and neck, lung, hematological malignancies, brain tumors, and prostate. Apart from the main stream molecules, we also have hormonal anti-cancer molecules for breast and prostate cancers," added Sanghavi. With this consolidation, the immediate move for Sun Pharma is to increase its market share by entering into several sub-segments of the oncology market, like targeted therapy, growth factor and chemo-induced fungal infection. Glenmark, which is mainly into generic business, has plans to tap both the biotech as well as the oncology space. The company is tight-lipped about its oncology plans and reluctant to reveal whether they are pure generic or biotech products. "We are too new in the space and are reluctant to reveal any plans," said a spokesperson. Biopharma major from Hyderabad, Bharat Biotech however has no plans to foray into oncology. When asked about the company's plans in this attractive segment, Dr Krishna Ella, chairman and managing director, Bharat Biotech International said, "We are not there in the oncology space. Unless some novel innovation comes in, we wouldn't do anything. I don't want to make any GCSF, GMCSF or interferons. We have 20 manufacturers already in India and everybody now is going in the same direction." Nayantara Som with inputs from Jahanara Parveen (Bangalore) and Shalini Gupta (New Delhi)   ]]> <![CDATA[Medical genomics gets democratized, some more]]> https://biospectrumindia.com/news/95/1033/medical-genomics-gets-democratized-some-more.html https://biospectrumindia.com/news/95/1033/medical-genomics-gets-democratized-some-more.html Tue, 14 Oct 2008 11:10:00 +0530 New Page 1 Medical genomics gets democratized, some more -Dr Edison Liu, President HUGO & Executive Director, GIS, Singapore Under its current President Dr Edison Liu's leadership, the Human Genome Organization (HUGO) is refocusing on two objectives: Genomic Medicine and Enabling Emerging Economies. In an interview with BioSpectrum, he elaborates on these overarching strategies and outlines the initiatives that are underway at HUGO. It's almost a year since you have taken over leadership at HUGO. What are the initiatives that are underway? There are two overarching content strategies that HUGO is focusing on. One is genomic medicine. That is applications in the knowledge form, genomic technologies put into medicine. The second is to work towards engaging and enabling emerging scientific countries in Asia, Latin America, Middle East and Africa. That does not mean we are turning our back on North America and Europe. Many of the developing countries are no longer struggling economies. India is a great example. In fact, these countries are significantly investing in science and technology. Now, it's obvious to everybody that we will find our solutions to human problems through science. As for the organization itself, at HUGO, I am focusing on organizational sustainability, which essentially involves building a pipeline of resources, creating visibility and vision. We would like to be thought leader in the field we are in. To achieve this there are functional initiatives underway. The first one is to restructure the office to make it more efficient. So, we have moved it from London to Singapore so that the office is closer to me. Then the Singapore government has put in significant amount of investments for the three years I am holding the office to help establish and manage it. This is the first meeting under my wing. And you can sense it follows the framework I have outlined. It focuses on genomic medicine and also India as a major component from the emerging countries focus. Subsequently, in 2010 the HGM will be in Montreal, France. In 2011, it will be Dubai and in 2013 in Singapore. Secondly, apart from improving the quality and impact of HGM meetings I am working on enhancing the portfolio of meetings and workshops. We are developing a series of symposia around issues pertinent to genomics. It covers five areas: genomics and infectious diseases; genomics and incurable diseases; genomics and ethics and society; genomics and human sustainability; genomics and bio-economy. Over next three years each one of these will be punctuated by a conference and we will also be launching a white paper that we would be writing with WHO on each of these areas. How much influence do you think HUGO commands? Influence as such is on an upstroke. However, organizations like HUGO cannot command anything nor do they want to. We like to be and are a forum for deep thoughtful discussion, a body where consensus can be heard, an arbitrator in case of complexities, a champion among governments to make the best and ethical science related to genetics possible. In this background, we want to be influential, and I think we are beginning to be so. We are excited about the future trajectory of HUGO. There is great potential. Practically, there is no other international organization of such history and global scope. There are a few human genetics and disease genetics focused societies but these are regional in nature and that partially comes from the medical framework that springs them to life. What would be your greatest challenge? Me greatest challenge is to boost HUGO membership and have more young scientists and researchers on board and inspire them to join the cause of medical genomics. The HUGO membership is open and there is just a basic vetting process to join in. Also, we are launching a new journal, Genomics Medicine. It will be our first such initiative to express out thoughts. We are also planning a series of niche workshops. I call them enabling workshops. The first one will be in Rotterdam and the second in Singapore and more will follow. Then, there is the case for education, which has many of our budding initiatives. We are talking to a publishing firm to put together a modular curriculum that can be used by developing countries to get started. The idea is to tailor it to a sufficiently practical level so they can start a small lab and move them to an investigative framework. Nandita Singh   ]]> <![CDATA[Regulator wants new GMP vaccine plants]]> https://biospectrumindia.com/news/95/1638/regulator-wants-new-gmp-vaccine-plants.html https://biospectrumindia.com/news/95/1638/regulator-wants-new-gmp-vaccine-plants.html Tue, 14 Oct 2008 10:58:00 +0530 New Page 1 Regulator wants new GMP vaccine plants -Dr Surinder Singh, Drug Controller General of India. India's vaccine industry has been facing a stormy weather due to the World Health Organization's (WHO) decision to go slow on products made in the country. This was because the government laboratories on which the Indian regulator, the Drug Controller General of India (DCGI), relied for tests had outdated facilities and were forced to shut down over quality issues. The three vaccine manufacturing plants in the public sector are located at the Central Research Institute (CRI), Kasauli, Himachal Pradesh, BIBCOL, Bulandshahr, Uttar Pradesh, and King's Institute, Chennai. The vaccine industry's cries over this "quality" issue threatening their export orders have been finally heard. The regulator has recommended a quick remedial action which can help remove the dark clouds hanging over the Rs 1,900 crore Indian vaccine industry. The regulator has recommended to the Ministry of Health to set up new GMP (Good Manufacturing Practices) compliant, global standards manufacturing plants urgently to resume production of vaccines in the government sector in the country. Excerpts from a media interaction with the Drug Controller General of India, Dr Surinder Singh, during the 6th Pharma Summit, organized by the Confederation of Indian Industry (CII) in Mumbai in mid-September Is the government going to modernize the three vaccine plants which have been shut down over quality issues? We have submitted a report to the Ministry of Health on this issue and it has concluded that the three facilities did not follow GMP and they cannot be modernized and made GMP compliant because these are very old institutions. Some of these institutions were set up over 100 years ago. So what is the way out? We have recommended that the essential vaccines which were made in these plants should continue to be manufactured in the country but not in these facilities but in new state-of the-art GMP-compliant facilities. What happens to the highly qualified technical personnel who were employed in the shut down facilities? We have to make the best use of the trained human resources available in the existing facilities. We have recommended granting approval to start the production of some important products like the yellow fever vaccine. Rabies tissue culture vaccines, seasonal influenza vaccine (because of reasons pertaining to national security) and typhoid vaccines. The new facilities could also increase the production of anti-serum, which is in short supply now. Are you going to increase the number of people at these plants? The Kasauli institution is looking at increasing the technical personnel from 40 to 150. The number could even go up to 200. This is because the country will require about 5,500 batches of these essential vaccines to be made here in a year. Will there be a shortage of vaccines in the country? Every year the country makes vaccines worth Rs 1,900 crore. Out of this, the domestic sales figure is only about Rs 400 crore and the remaining Rs 1,500 crore is exported. Every third child in the world is immunized with measles vaccine made in India. Around 70 percent of the global supplies of this vaccine are from India. In fact, India had exported about 80 million doses of measles vaccine to Pakistan recently. There is no shortage of vaccine for the public health system in the country. There could, however, be some issues relating to timely procurement. Vaccine industry has been complaining about the low prices given to them during procurement. What is the reality? Pricing is not at all an issue. For example, an institute with the best GMP facilities manufacturing BCG vaccines would export it at a price of Rs 40 to foreign countries whereas to the Government of India it will be sold at a price of Rs 17. Is the country improving the regulatory standards? This is something we are working on. We are at present collaborating with the WHO for training activities and with the USFDA and Health Canada for other aspects. Vaccine manufacturers can now submit their revamp plans electronically. We are also introducing various e-Governance measures to bring reliability, accountability and adherence to timelines. Proposed initiatives include setting up LAN/WAN connectivity of CDSCO campus, online submission of all forms, digitalized interactive portal, digitalization of records and online approvals with digital sign.   ]]> <![CDATA[Vaccine makers pour their heart out]]> https://biospectrumindia.com/news/95/7404/vaccine-makers-pour-their-heart-out.html https://biospectrumindia.com/news/95/7404/vaccine-makers-pour-their-heart-out.html Tue, 14 Oct 2008 10:57:00 +0530 New Page 1 Vaccine makers pour their heart out The vaccine manufacturers in the country, mainly the exporters, have been at the receiving end of a threat by the World Health Organization (WHO) to stop buying of their supplied vaccines. This was due to the shutting down of three public sector vaccine manufacturing units which were providing the testing facilities to the Indian drug regulatory agency. To understand this issue better and help forge a united front to take remedial action, BioSpectrum organized an Industry Forum on the issues facing the Indian vaccine industry in Mumbai on August 28, 2008. The Forum was sponsored by Bio-Rad and supported by the UK Trade and Investment agency. The panel discussion was moderated by BioSpectrum Group Editor, Narayanan Suresh. The five panelists were: Dr Cyrus Poonawalla, Chairman, Serum Institute of India, Pune; Dr Krishna Ella, CMD, Bharat Biotech International, Hyderabad; Mr KV Balasubramaniam, MD, Indian Immunologicals, Hyderabad; Dr Masood Alam, CEO, Chiron Panacea Vaccine and country head of Novartis; and Dr Arvind Lali, Professor at UICT, Mumbai. VACCINES PANEL (L-R): Biospectrum Editor, N Suresh; Dr Krishna M Ella, CMD, Bharat Biotech, Hyderabad; KV Balasubramaniam, MD, Indian Immunologicals, Hyderabad; Dr Cyrus Poonawalla, Chairman, Serum Institute of India, Pune; Dr Arvind Lali, Professor, UICT, Mumbai; and Dr Masood Alam, CEO, Chiron Panacea Vaccine and Country Head of Novartis, Mumbai. Highlights from panel discussions: Suresh: What is the genesis of the problem and how will it impact the Indian vaccine industry? Cyrus Poonawalla: About 18 months ago we were first given an indication by the WHO that after an inspection of the private sector and public sector organizations, particularly the biologicals, they were extremely disturbed by the lack of GMP at many of these units. The public sector companies which were shut down were in extremely pathetic conditions and the National Regulatory Agency (NRA--the combination of the Drug Controller General of India, Ministry of Health, and the three government units where drug tests are done) was being questioned for two-three months by the WHO and other health agencies. These agencies questioned the double standards which allowed top-class private facilities and public units which had poor facilities with no quality or accountability. They were also sad about non-allocation of government funds for the modernization of these public units. Now who is to be blamed for all this mess is a separate issue, but the issue here was that they were continuously giving negative reports and were threatening the health ministry that they would have to take the extreme step of derecognizing the NRA of India, which would negate the global recognition of the Indian vaccine manufacturers. The second issue was the functioning of the NRA, their surveillance methods, licensing issue, policies and clinical trials and the general licensing policy. There were question marks over these issues too. The Indian government agencies relented for some time and agreed to an inspection by a Canadian team to guide them and lay down the rules which they must follow. It was agreed that if WHO was satisfied after this, it will temporarily lift the ban on Indian agencies. Now how does it affect the industry as a whole? The WHO, apart from the threat of delicensing, which will be a disaster, will stay any new vaccine dossier applications. Any vaccine that any company wants to launch or new entrants who want to come in and file their applications will be frozen till the NRA issue is solved. This is a very critical issue which the health ministry must look at seriously. This issue has been dragging on for the last 18 months. However, the ministry started to act only some five months ago. Balasubramaniam: The basic problem here is that we have an NRA but there is no independence to the NRA as it reports to the ministry of health. If WHO has said that it will derecognize the NRA it is because there was a lack of authority for the functioning of the public sector units or other private sector units. Another issue is that a multitude of agencies are involved in the regulatory process. We have the central CBSO and various state-level regulatory authorities. I can talk from my animal vaccine experience that even for an animal vaccine we do not have a permanent body which evaluates the vaccines to be introduced in the marketplace. So the whole regulatory framework is not very clear, there is no independent regulatory framework. But I think we have to look at the larger issues and we have to look at long-term issues. I agree we must have vaccines which have high quality standards but then we have to address the basic issues and only then you will have a stronger regulatory system and you will not have issues in future. Today the government follows pre-qualifications approved by the WHO which is not reflected in the national situation. My organization has followed WHO standards and we have also been affected because some of our applications have been put on hold. So I hope that the government gets more serious about the issue and takes some long term steps to address this issue. Alam: On one hand we are looking at coming up with value-added vaccines which can change the situation in India and then take it globally but here the gatekeeper is questioned and unless these issues are resolved we cannot move forward . And regulators must move in an accelerated way to solve these issues. If you have a vaccine to take it globally, you don't have a serology lab to test them. You have the technology but no facilities to test them and your regulatory filings get stuck. Poonawalla: All these highlight the inadequacies of the NRA in testing and even releasing the existing products. The National Institute of Biologicals, which is going to be the central drug testing authority, has been set up near Delhi but it has not even taken up the issue. Even if they conduct a meeting, half of the members come late and half of them leave early. And the National Control Laboratory at Kasauli is incapable of handling issues with regards to the release of existing products. Moreover inadequate manpower is another issue. They are transferred from these poor facilities to better ones in a year's time and if the facilities are improved, they can work on the new and existing products and we can really move forward. Ella: UNICEF and WHO does not have testing facilities. So they say your testing facilities should be up to my standard. So they entrust the local governments to have a certified lab to meet their requirements. So we are the most victimized people because we are supposed to follow all the guidelines. Unlike biopharma, vaccines come under two different regulations not only in India but worldwide. I feel the reason for our problems is the vaccine manufacturers do not have an association. Today the cost of vaccines is cheaper than the price of a bottle of water. If we do not have funds where do we have the resources and now it is a handful of vaccine players. So there is also a pricing issue. There should be an association to represent ourselves. In India, we work in a pressure-cooker like environment, with jealous industry people. In fact I have been questioned by foreign delegates as to whether we have any association where we are represented. Arvind: We have to build vaccines at a decent price using processes which are far more innovative today. Innovation is required both at the molecular engineering level and process engineering level. But where is this innovation going to come from? So one possibility is in investing on education. But what is the industry doing in terms of investing in education? Industry says we are not able to produce good graduates. But we say there is no industry participation. Poonawalla: The WHO is concerned more about how a product is made right from the beginning and the checks that went on it rather than the final product and that is totally lacking especially in the public sector. The public sector could not upgrade its facilities in the last 40 years. As Dr Ella was pointing out because the vaccine cost which is given to them by the procurement agency is so mean that 10 doses of DPT vaccine is given at a price lesser than that of a bottle of water. The public sector has no choice. When they are giving an adjuvant toxoid vaccine at Rs 0.70 per dose, how can they manage GMP standards and they became sick and the same can happen to private companies who are now forced to supply at these prices to the government of India. The government's immunization programs will not be able to sustain and manage good manufacturing practices in the country. This has finally led to the complete ruination of the public sector vaccine manufacturing units. Suresh: Can we bypass the NRA and get it tested in a lab abroad and then get it certified by WHO? Poonawalla: Yes! but it is a complicated issue. The country of origin should approve it first. Indian vaccine companies never had to meet the hurdle of high expectations right from the beginning and got used to an easy way of life. It is quite easy to get your vaccine approved in Kasauli than in a Switzerland laboratory. Even if government wants to follow WHO guidelines, you don't have people capable of doing that so you have to get people from Canada. It is not something that the government can do, it is something that the private agencies have to do and get together and create an Indian association which is independent and they inspect the facilities of members and over a time build and do the accreditation and cross certify. Ella: In vaccines QC and GMP is much more stringent than biopharma and testing is very complicated compared to biopharma.   ]]> <![CDATA[Induced Pluripotent Stem Cells]]> https://biospectrumindia.com/news/95/1158/induced-pluripotent-stem-cells.html https://biospectrumindia.com/news/95/1158/induced-pluripotent-stem-cells.html Wed, 17 Sep 2008 10:23:00 +0530 New Page 1 Induced Pluripotent Stem Cells Roadmap to replace current stem cell models is still a long way before commercialization. Dr Jyoti Kode Dr Kode is Scientific Officer "E" at Chiplunkar Lab, Advanced Centre for Treatment, Research & Education in Cancer, Tata Memorial Centre, Navi Mumbai. Being immunologist and biotechnologist, she keeps herself updated with stem cell market trend and commercialization of cell-based products. She can be reached at jkode@actrec.gov.in Over the past 20 months, reports claiming the generation of Induced Pluripotent Stem (iPS) cells from somatic cells and having embryonic stem (ES) cell-like characteristics, has captured great attention of scientific community and general public. A lot of enthusiasm was generated particularly in the Western countries since iPS cell line was proving to be a viable alternative to the controversial Embryonic Stem Cells. This led to the rapid and premature acceptance of using iPS cells for regenerative therapy. How convincing are the evidences supporting the various claims made for the iPS cells? Are there other more plausible explanations for the same observation? What are these iPS cells? Are they really safe for therapeutic use? Should the iPS technique be considered, in the absence of any direct evidence for induction and reprogramming, as a realistic alternative for somatic cell nuclear transfer (SCNT) to generating ES-like cells? Evolution of iPS An astonishing breakthrough in Stem Cells occurred in 2006 when Yamanaka et al demonstrated that iPS cells could be generated from mouse embryonic or adult fibroblasts by retrovirus-mediated introduction of four factors Oct3/4, Sox2, c-Myc and Klf4. These iPS cells were similar to ES cells in morphology and teratoma formation4. The race then began in establishing a similar result in humans and incidentally the race ended in a tie when Yamanaka's group from the Kyoto's University along with Thomson's group from the University of Wisconsin-Madison both reported that they were able to reprogram a Human Somatic cell into an embryonic stem-like cell. Shi et al explored alternative strategy combining genetic and chemical approach wherein small molecules were capable of replacing viral integration of certain transcription factors and promote reprogramming process. Use of specific small molecule inhibitors suggests that loss of function of certain genes may be an effective mechanism for generating iPS cells. This study has generated hope that the use of additional small molecules or other non genetic methods could improve reprogramming that could ultimately allow the generation of iPS cells or multipotent tissue-specific stem cells in completely chemically defined conditions without any genetic modification. iPS technology hogged the limelight in the 6th Annual Meeting of International Society for Stem Cell Research which was held at Philadelphia from June 11-14, 2008. Shinya Yamanaka announced in Closing Plenary session about development in terms of characterization, directed differentiation of iPS cells into neurons and beating cardiomyocytes. iPS cells have high clonogenic potential. They express ES cell-specific antigen profile. These cells have growth potential, gene expression pattern, telomerase activities and epigenetic status similar to ES cells. Applications of iPS cell technology iPS cells promise several practical applications. Procedures already validated for ES cells will investigate iPS cells' potential to differentiate into functioning, specialized tissues. Working in sickle-cell anaemia, Rudolf Jaenisch and co-workers have already shown, in an elegant proof-of-concept study in the mouse, how reprogramming, tissue-specific differentiation and gene therapy can be used to cure inherited disorders. The potential advantage of using this technology will be for generation of patient-specific cells and evaluation of diagnostic or pharmacological tests in an individualized medicine approach. In contrast to the term "therapeutic cloning" coined for SCNT-derived applications, this would be "therapeutic reprogramming". As with other biomedical research discoveries, the fields that will benefit most from these recent discoveries are that of Tissue engineering and regenerative medicine where customized tissue grafts could be made from a persons' own adult fibroblastic cell. In addition, the technology may help avoid immune rejection of replacement tissues, because an adult patient's cell could be the source of stem cells that are a genetic match to that individual. Indeed, the potential applications for iPS technology are endless. An overlooked application of iPS cells would be using them to bypass the difficulty of working with species for which establishing ES cells is difficult or impossible. The ability to perform genetic manipulations would help to engineer traits such as disease resistance or greater muscle mass in domestic or threatened animals. Freezing batches of iPS cells from endangered species may also help to preserve them. Ethical concern The technology sidesteps the ethical objections raised against research in human embryonic stem cells, which are derived from early stage human embryos that are often destroyed in the process. The new technique is not without its own set of limitations, although some of those have already been resolved. One of the original genes used for reprogramming (c-MYC) has been shown to produce tumors and cancers. With current level of knowledge, it would not be a preferred choice for patient therapy. Commercialization This is a consequence of any research that will have a major impact on future therapeutic interventions. As a step towards development and commercialization, Japan Education, Science & Technology Ministry has established CiRA, Centre for iPS research & Application and allocated approximately 1 billion yen ($10 million). CiRA will promote basic research and clinical application of iPS cells in understanding disease mechanisms, drug screening, toxicology and regenerative medicine. Collaborative work between iZumi Foundation and San Francisco based J David of Gladstone Institutes are undertaking research in iPS cells that can be coaxed to regenerate injured spinal cords or damaged hearts. PrimeGen Biotech from Irvine, CA, USA (www.primegenbiotech.com) has claimed to have successfully used non-viral technologies to reprogram adult human cells into stem cells that the Company refers to as intermediate iPS cells. They employed high efficiency particle delivery system to transport proteins and DNA molecules directly into cells from human skin, retina & kidney. They are the first to use methods that do not involve potentially tumor-causing viruses or genetic manipulations. They report that this method is faster and efficient than other known methods. However, they have not yet disclosed the details which need to be validated by various laboratories. At the 6th Annual meeting of ISSCR at Philadelphia, Timothy Caulfield from Health Law Institute, University of Alberta, Canada presented coverage on market opportunities associated with translation of stem cell research. He expressed concern over marketing therapies with current state of information, exploitation of desperate patients, the erosion of public trust and issues of safety. Stem cell therapy market has been emerging fast on the basis of legitimate hope, substantial media coverage, lack of appropriate regulatory board and tall therapeutic claims. As per review by Select Biosciences Industry Tracking 2007 (www.selectbiosciences.com), the pharmaceutical and biotechnology community is in wait-and-watch mode with stem cell based therapy and majority of research is conducted in academic/university research communities. Induction of pluripotency to produce embryonic-like stem cells is the hot field in stem cell research. The fact is that iPS cells have been produced in at least six different laboratories within a few months after the initial animal studies shows that the technique is robust and easily reproducible. At this point, it seems pretty certain that the iPS technique will soon replace ES cells as the preferred means of generating human stem cell lines. However, this study is still in infancy of basic science, the practical aspect of a therapy using autologous iPS is not yet clear. The safety and efficacy of these cells need to be worked out before testing in human Clinical trials. Co-author: Winston Costa Pereira Winston Costa Pereira is Research Scientist at LifeCell International Pvt Ltd, Chennai, and can be reached at winston.c@lifecellinternational.com ]]> <![CDATA[Computational technologies in drug discovery]]> https://biospectrumindia.com/news/95/2227/computational-technologies-in-drug-discovery.html https://biospectrumindia.com/news/95/2227/computational-technologies-in-drug-discovery.html Wed, 10 Sep 2008 15:58:00 +0530 New Page 1 Computational technologies in drug discovery Computational technologies are more than exotic play tools, impacting research productivity in a discovery program and more. Supreet Deshpande The author is currently the CEO of Vlife Sciences Pvt Ltd. He has over 17 years of experience in business development and has worked with large multinational companies in the past. He can be contacted at supreet@vlifescieces.com Deciphering of human genome and advancements in proteomics have each been watershed events for drug discoverers. These dramatic advancements have left a world target-rich but drug-poor. Computational technologies prophesying to make best use of this rich target information have remained focused on creating "Awe" in the minds of users but have been often found short of creating a "Wow" for the patients. In the not too past, unrealistic expectations set by vested interests created a bioinformatics bubble. Subsequent bursting of the bubble cast doubts in the minds of serious researchers about the utility of computational technologies. Does this mean computational technologies remain only exotic play tools and no more? The answer is an emphatic no.   Impact of computational technologies Computational technologies significantly impact Research Productivity in a discovery program. Taking example of the Pharmaceutical Sector where a drug takes 12-15 years to move from an "Idea" to "Market" involving an expense of over $1 billion (Source: Tuft's University, USA), computational technologies have become an integral part of any discovery program. Majority of the expenditure in early stage drug research goes towards failures, lost forever. The use of advanced computational technologies in drug discovery leads to better designed, comprehensively studied pre-clinical candidates, which have better chance of success in the subsequent laboratory experimentation. An artist's representation of the aforesaid is given below: Computational technologies can help a drug researcher in multiple ways. They enable expansion of the initial chemical exploration space manifold, which is not feasible in a time and cost intensive laboratory-centric effort. They help the development of a robust molecule design criteria taking cognizance of the needs of protein target and information of known active compounds against that protein from historical research. They enable multiple 'what if' scenario try-outs before even entering a laboratory. They allow pursuit of a structure based research program even when the three dimensional protein structure is not available. Finally, they enable virtual screening of a chemical space on various aspects thus preempting later stage failures on account of efficacy, toxicity and bio-availability. The successful application of computational technologies in a discovery research program significantly depends on three factors. The first factor is the selection of the RIGHT technology, second is knowledge of the researcher about the limitations of the technology in addition to its strengths and the third and most important factor is establishing CORRECT expectations from that technology. The differentiators among various computational technologies One computational technology differs from the other primarily due to the mathematical algorithms underlying each research function that it allows to do. These mathematical algorithms are expected to reproduce known experimental results obtained through historical experiments. The accuracy and the speed of computational study and the technology's ability to handle complex biological and chemical structures depend largely on the underlying mathematical algorithm. The second critical differentiator is the number of various ways, the technology presents to do a particular work. E.g. If one needs to perform a QSAR study, a technology which incorporates more statistical methods for predictive model building, the more options the user has to arrive at a closer to reality model or utilize a Consensus approach for Go-No go decisions based on the output of multiple methods. The third differentiating aspect is the quality of the graphical representation that a computational technology can achieve for complex proteins and alien chemistries. This aspect becomes particularly critical when the out of the computational technology is to be used for scientific publications and when a researcher has to use a technology for long durations. This holds true also for various analytical graphs that the technology can generate to enable user correct interpretation of the results of computational study. The fourth important aspect is the Graphic User Interface. Simpler and more intuitive the interface, the shorter is the learning curve for a new user. It is a critical consideration when a company chooses to move from one computational technology to another. Also, in an industrial environment where time is critical, an intuitive GUI helps the user to complete the experiment faster than a command line based instruction submission. Selecting the RIGHT technology There is no technology for computer aided drug discovery which can be BEST for all types of biological and chemical universe, given that it is extremely large. Therefore often, companies having significant cash out-lay for technology acquisition acquire multiple technologies and utilize them for their specific strengths. To choose the right technology it is important to benchmark various available options against each other on 'Accuracy', 'Speed' and 'Complexity handling' parameters and thus identify the better technology. Such benchmarking studies play a significant role in helping to make the crucial buying decision. Benchmarking studies compare the output from multiple technologies for a specific functionality; say 'Docking', on a common data-set. While making their buying decision based on benchmarking studies, the purchaser must establish that the data-set is unbiased for a specific technology. The benchmarking study ideally must include comparison of competing technologies on. A technology vendor who presents benchmarking results on the main competitor's data-set is most believable and credible. An important consideration in selecting a computational technology is the after sale support that a vendor is able to provide. A technology provider who has full access and ownership of the underlying code must be preferred, as they can provide customization of the technology to suite your specific needs. It is important however to remember while making a buying decision that the price of a computational technology license is not directly indicative of its superiority. Often, there are drivers other than a technology edge that drive a cost, which may not be of direct scientific relevance to your research requirement. Additionally, caution must be exercised in getting swayed by the brand perception. Older the technology brand in the market does not necessarily mean that the technology continues to retain competitive superiority. Often new technology vendors with significant focus on in-house innovation present a more advanced technology. How to make best use of computational technologies? Any technology is ultimately a tool and no tool delivers by itself. For exploiting the capabilities of a tool, in this case being computational technologies, the user of the technology must be knowledgeable not only in use of technology but strong in fundamentals of science as well. Thus the user ought to: Know the limitations of technology as much as its strengths Set RIGHT expectations Purchase the best technology based on criteria of Accuracy, Speed and ability to better handle biological and chemical complexities Recruit scientific talent that is familiar with the use of advanced technologies and with strong domain knowledge Choose a vendor who provides strong after sale support and has capability to undertake training workshops within your organization to help conventional researchers overcome their inhibitions in using advanced technologies Knowing the capabilities and limitations of computational technology can thus enable its user to make its optimal use for improving their research productivity. With such an insight into the technology scientists can equip themselves with the correct criteria on which the technology can be evaluated and compared and help themselves in making the best choice. This combination of scientific know-how and the power of computational technologies can bring to fruition the promises held out by modern genomics and proteomics and significantly expedite the process of bringing new drugs for the benefit of the mankind. The views expressed herein are the personal views of the authors and do not necessarily represent the views of the company they represent or any of its member firms.   ]]> <![CDATA[Enterprise Content Management for your Growing Laboratory]]> https://biospectrumindia.com/news/95/2089/enterprise-content-management-for-your-growing-laboratory.html https://biospectrumindia.com/news/95/2089/enterprise-content-management-for-your-growing-laboratory.html Wed, 10 Sep 2008 15:50:00 +0530 New Page 1 Enterprise Content Management for your Growing Laboratory The best solution for this "information overload" challenge is a solid "Enterprise Content Management" strategy. Tanay Waingankar The author is the Marketing Program Manager for Agilent's Life Science business in India since 2007. He has a rich varied experience of over 10 years in domestic and international business for Life Science & Clinical Diagnostics.Email: tanay.waingankar@agilent.com One of the biggest challenges for life sciences companies today is dealing with the sheer volume of data they need to work with. We're experiencing a literal explosion of data with advancements in scientific research and high throughput analytical techniques. The majority of this information is unstructured and heterogeneous, making it difficult to organize, find and reuse. Large and small organizations generate millions of electronic files each year, which is spread across many disparate silos. This situation presents many challenges. How can you logically organize this data? How can you make all the data "safe" and secure? How can you make all the different data searchable and shareable? How can you make all the data viewable from different places? How can you handle laboratory data as part of your company's business processes? Clearly a powerful way of organizing and harnessing data for easy access, retrieval and re-use is needed in today's competitive business environment. The best solution for this "information overload" challenge is a solid "Enterprise Content Management" strategy. The Value of Content Management A content manager such as Enterprise Content Management can solve these issues. It's an electronic library that provides a secure, central repository to store all of your information, with rich content services to capture, manage, collaborate, archive and reuse information. Records placed in the repository are automatically indexed, allowing for rapid searching and retrieval. Content Management Systems can help your organization gain control of critical information while improving compliance, enabling collaboration and protecting intellectual property. An ECM has the unique ability to manage data generated from analytical instruments and measurement devices as well all types of documents including word processing, spreadsheets, PDF files, graphics, images, email, HTML files and more. Since it's web based, you can access any file, anytime from anywhere for review, collaboration and reporting. This can be from any point on your intranet, or externally over the Internet. Obviously you need to get data into the ECM for it to be useful. You can add data manually through the web client, or from within MS Office Applications. Data can be transferred directly from another system such as LIMS. It can be automatically uploaded through a scheduler â€“ for example anytime a new file is created or changed. Or you can even "print" files in PDF format directly to the ECM. Organizing the data for easy access is just as important as getting it in there. Content is organized in an intuitive, flexible structure of Locations, Cabinets, Drawers and Folders that is easy to visualize. Each Location can contain an unlimited number of Cabinets, Drawers and Folders. There's also an upper level structure of accounts that allow you to configure multiple hierarchies on the same system. Accessing the data is also intuitive. Built in data viewers allow you to view a wide variety of content without having to load the native application on your PC. These viewers support a wide variety of files from commercial data systems. Right clicking on a file brings up a menu of content management services. Indexing data for easy retrieval While the content hierarchy makes it easy to browse data, you won't always know where information is especially as the volume grows. This is where indexing comes in. When a file is imported to the ECM, information is automatically extracted and saved to a database. This extraction contains basic information on the file to identify where it came from, who placed it there and when it was created, but also a rich set of metadata to describe the content and make it easy to find later on. You can expand the extraction service to glean more information for searching â€“ and then automatically re-key the files in the repository. Since the files are indexed with this rich set of information, you can search the data to quickly find exactly what you need â€“ regardless of location or file type. Keeping your content secure & compliant One of the major benefits of ECM is keeping your content secure and helping you maintain regulatory compliance. There's a complete feature set to satisfy the requirements of 21 CFR Part 11, including login security, a complete audit trail of system activities, electronic signatures, secure file transfers, version control, and check in/check out. Another level of security comes with the new SAFE (Secure-Access-for-Everyone) standard, a consortium of biopharma companies developed this as a global standard for legally binding electronic signatures Managing the complete lifecycle of electronic records As your content ages and the need for immediate access diminish, the ECM can automatically migrate your electronic content from on-line storage to secondary or off-line storage devices. Record retention features provide the final stage in content management; destruction based on corporate and regulatory regulations. File expiration policies are event-driven with configurable retention periods. Another challenge we're all faced with is preserving legacy data for long periods of time. Data often has to be kept long after the system that created it becomes obsolete. The typical solution is to keep an instance of this system alive to store and view the data when needed. With ECM you can convert this data to a TNF, and place it in the ECM for long-term storage and reuse. TNF converters are available for various formats, with more in development. ECM architecture that grows with you from single laboratory...to global deployment To make an ECM useful across your company, the architecture needs to be scalable and have the flexibility to adapt as your needs change. The complete system can fit on a single server....Or scale it up to a large global implementation. Modules such as the database, web server, application server, or file transfer server can be installed on separate machines. These functions â€“ individually or together â€“ can operate a single server, or be load balanced across a server farm. This gives you freedom to configure the system to meet your needs. Things to remember Provides a secure, central repository and rich content services for capturing, managing, archiving, collaboration and re-use of business critical information Improves compliance with corporate and regulatory requirements for managing electronic records Enhances productivity, increases operational efficiency and streamlines laboratory business processes The views expressed herein are the personal views of the authors and do not necessarily represent the views of the company they represent or any of its member firms.   ]]> <![CDATA[A Microfluidic HPLC-Chip]]> https://biospectrumindia.com/news/95/6946/a-microfluidic-hplc-chip.html https://biospectrumindia.com/news/95/6946/a-microfluidic-hplc-chip.html Wed, 10 Sep 2008 12:53:00 +0530 New Page 1 A Microfluidic HPLC-Chip Microfluidics based nano HPLC device can be used for reproducible and rugged chromatography coupled to Mass Spectrometry. Dr Ajit Srivastava He is the Manager for Agilent Technologies LCMS business in India since 2005. A scientist by education with a management degree, he started his career in 1994 as a scientist and later shifted into the field of Mass Spectrometry. He holds a vast experience of over 10 years in LCMS for Life Science & Chemical Analysis. Nanoflow chromatography coupled to Mass spectrometry is often the method of choice for analyzing samples that are very small in volume (typically 1 to 2 microlitre) and low in concentration. The application areas of nanoflow chromatography span from proteomic analyses to small molecule analyses. It provides a specific and highly efficient technology for analyses of low volume and low concentration samples despite challenges associated with it. Plumbing a nano HPLC without leakages can be a herculean task in itself and requires a lot of expertise and experience on the user front. The dead volume contributed by the capillaries, fittings and the tubing causes chromatographic degradation and leads to irreproducible and low confidence results Micro fluidic chip devices are designed to be used at Nano and Pico flowrates and can integrate most functional components of a conventional nanocloumn directly onto a chip. A microfluidic HPLC-Chip can integrate enrichment and analytical nanocolumns, nanospray emitter, fittings and connection capillaries directly on a reusable biocompatible polymer chip. An automated HPLC-Chip interface ensures solvent and sample delivery to the chip, high pressure flow switching and automated chip loading and positioning in front of the MS inlet. The Chip interfaces with the Mass spectrometer in a seamless fashion through a device which is mounted on the mass spectrometer. It has a Chip loading and ejection mechanism and connects to the nano flow pumps and autosampler. It is equipped with a microvalve for switching the solvent flow through a rotor and stator arrangement. The HPLC chip has all the embedded electrical connections and can be replaced in seconds. It can also have a radio frequency (RF) tag for identification. The chips are reusable like any other conventional nano columns and gives a higher performance in terms of reproducibility and ruggedness. It provides ease of use by reducing the problems associated with conventional nanoflow HPLC and gives higher throughput by reducing the chromatographic runtimes with much more efficient and better results. The technology can be used for proteomics and small molecule applications with equal efficiency and robustness. The reproducibility and sensitivity of the technology makes it an ideal choice for low volume and low concentration samples. The views expressed herein are the personal views of the authors and do not necessarily represent the views of the company they represent or any of its member firms.   ]]> <![CDATA[Electronic Health Data Holds Potential to Hasten NDRs]]> https://biospectrumindia.com/news/95/2756/electronic-health-data-holds-potential-to-hasten-ndrs.html https://biospectrumindia.com/news/95/2756/electronic-health-data-holds-potential-to-hasten-ndrs.html Wed, 10 Sep 2008 12:49:00 +0530 New Page 1 Electronic Health Data Holds Potential to Hasten NDRs EMR can help pharmaceutical companies reduce research costs and accelerate time to market for new drugs. Callum Bir The author is Director, Life Sciences, Global Industry Business Unit, Oracle Corporation, Asia Pacific and Japan Electronic Medical Records (EMR), software that allows the creation, storage, editing and retrieval of a patient's data on a computer, and to a lesser extent Electronic/Personal Health Records (EHR/PHR) have been making strides around the world. Many hospitals or hospital clusters have to some extent either implemented EMRs or are in the process of doing so. Many countries around the region are also looking at putting in place the infrastructure that would support EHR/PHR as well. Countries like Singapore, Australia, Taiwan, Malaysia and Hong Kong have made significant progress in both these areas and there will be more to come. As exciting, but often less reported, however, are the potential benefits such initiatives can deliver to the life sciences and biomedical industry. There are significant crossover benefits that take aim at some of the industry's most vexing challenges-more effective and efficient identification and recruitment of clinical trial participants and the ability to simultaneously capture clinical trial data from the electronic health record to decrease the costs of clinical trials, resulting in faster time-to-market for new drugs. Wanted faster, more cost-effective clinical trial recruitment With the average cost of developing a new prescription drug creeping toward US$1 billion and the process often spanning more than a decade, pharmaceutical manufacturers are continually searching for ways to extend efficiencies at all stages of the development continuum, allowing them to bring safe products to market faster and at a lower cost. Clinical trials, which average $124 million per drug candidate after accounting for drug failure rates (Di Masi, JA, Hansen, R.W., Grabowski, H.G. "The Price of Innovation: New Estimates of Drug Development Costs," Journal of Health Economics, 2003) and whose costs are rising faster than pre-clinical research and development activities-are a prime target for scrutiny. Rising clinical trial costs can be attributed to several factors, including new challenges related to trial candidate identification and recruitment. Clinical trial patient recruitment is also an increasingly time-consuming process. One study, which looked at 4,000 clinical trials over five years, discovered that nearly half of the time spent on the trial process involved patient, site and investigator recruitment. On average, difficulties in patient enrollment delay 81 percent of all clinical trials from one to six months, costing pharmaceutical companies as much as $8 million each day. This figure does not take into account the human costs of such delays in terms of the inevitable morbidity and mortality when promising new drugs are delayed in reaching the market. Connecting EMR and clinical trials Today, initiatives at individual investigation sites in the United States, Europe and Asia are revealing glimpses into the potential of patient's EMR data to transform clinical trial recruitment. This will require biomedical and life sciences to work together in terms of information exchange. The pharmaceutical company will provide physicians, in both the public and the private sector, with information on the clinical trials currently being conducted, as well as the selection criteria for the trials. The physicians, on the other hand, could reference a patient's EMR during a routine examination to determine if the patient meets eligibility requirement for a particular clinical trial based on the record and the trial requirements. If a patient matches the criteria for any study, the physician could immediately collect the additional information required for the trial from the patient, record the data in the EMR and send an electronic notification to the relevant party. At that point, screening for the trial is completed--within a matter of minutes. By combining electronic health records with data mining tools, pharmaceutical companies can also have the potential to quickly query the EMR database to determine the number of potential candidates for a specific study and to assess the viability of candidates for a specific trial. They can also potentially and quickly screen large numbers of anonymized electronic records for potential trial candidates using any number of factors, including age, sex, co-morbidities, lab results etc.In this way, pharmaceutical companies could efficiently approach physician groups that they know treat significant numbers of patients matching a specific trial candidate profile. This method could be particularly useful when recruiting for trials for drugs intended to treat rare conditions, as the trial sponsor from the pharmaceutical or biomedical company could efficiently search for specific criteria. The end result could be faster and more cost-effective trial participant identification and recruitment-ultimately accelerating time-to-market. While the approach outlined above would enable more effective targeting of physician practices that treat viable candidates, another approach being advanced would take information on clinical trials directly to the potential candidates. It would involve the creation of a patient opt-in mechanism, in which individuals would grant permission to have life sciences organizations access their health information via the EMR and when launching a clinical trial, to contact them directly. This approach could go a long way toward empowering patients to take charge of key health decisions, as well as streamlining the participant recruitment process. To optimize the success of this approach, physicians would also need to be notified, in tandem, when trial sponsor contacts their patients. Once a patient is enrolled in a trial, researchers could then incorporate data captured from a specific study as part of the EMR and routine clinical care by physicians. Automating these processes can help accelerate clinical trials by streamlining patient enrollment and documentation. If all the relevant trial and medical information is available to the doctor in the form of EMR, the physicians are able to make accurate and correct diagnosis 80% of the time. Electronic records, an imperative need to overcome hurdles The conversion from paper records to electronic records in the healthcare system will be a complex one. Issues such as data privacy, data protection, regulation and audit have to be addressed. Having said that, the healthcare and life sciences industries are optimistic about the potential of electronic health data to transform the delivery of healthcare as well as the drug development process, including spurring advances in the quest for personalized and translational treatments and therapies. The critical technology components needed to enable meaningful exchange of information between the healthcare and life sciences industry exist today-as do the data mining and analytical tools needed to interpret data and drive incisive action. By combining these core technologies with proper planning and vision, electronic health records offer one of the brightest hopes for the future of the healthcare and life sciences industries and their quest to save and enhance the quality of lives. The views expressed herein are the personal views of the authors and do not necessarily represent the views of the company they represent or any of its member firms.   ]]> <![CDATA[SMOs, India's Next Frontier in Clinical Research]]> https://biospectrumindia.com/news/95/2888/smos-indias-next-frontier-in-clinical-research.html https://biospectrumindia.com/news/95/2888/smos-indias-next-frontier-in-clinical-research.html Wed, 10 Sep 2008 12:23:00 +0530 New Page 1 SMOs, India's Next Frontier in Clinical Research Site Management Organizations are the new breed of service providers helping in principal investigator selection, patient recruitment and regulatory and contract management and research support for multiple sites. Dr K Sashi Kiran The author is managing director, D2L Pharma Research Solutions Pvt Ltd (D2L-SMO), India Quality assurance and timelines have always been a serious concern to the rapidly growing clinical research market in India. With India now being seen as a hub for clinical trials, the challenge is to gear up to accomplish these expected standards. The growing demand for new ICH-GCP compliant sites, qualified investigators, vast patient pool and experienced staff only adds commotion to the industry. It is under such circumstances that a new set of service providers has emerged in the clinical research market-Site Management Organizations (SMOs). These SMOs' role in meeting the sponsor's and the CRO's requirements is being greatly appreciated. Multi-site SMOs SMOs play a major role in the trials offering Training and assisting the investigators throughout the study Ensuring faster recruitment of the subjects Assisting PI s in adhering to the protocol High-quality data entry Mounting the protocol-specific infrastructure in tim The market share CROs will continue to increase their share in the next five years, but the mix of non-CRO players is also a dynamic one. Though Non-CROs are many, the major chunk of the business is enjoyed by the Academic Medical Centers (AMCs). The SMOs are expanding their operations and striving to provide quality services to increase their share in the clinical research market pie. Role of SMOs in clinical research While CROs offer a variety of services to the sponsor such as monitoring, contract administration, study supplies shipping and receiving and data management, SMOs offer principal investigator selection, patient recruitment and regulatory and contract management and research support for multiple sites. There are two operational models which SMOs follow--one which is confined to a single site or a therapeutic segment and the other which work on multiple sites and specialty segments. SMOs have substantiated their contribution from training young, dynamic and inexperienced investigators with GCP guidelines and providing them an opportunity to conduct clinical trials. The investigators are relieved from time-consuming, non-clinical tasks like data entry and documentations, thus allowing them to concentrate more on the recruitment. An advantage of working with the site and investigator in close proximity and an access to the local clinical and logistic requirements keeps them far ahead for planning and completion of an assignment. Unlike the sponsors or the CROs, they also have an access to the various hospital data at the site. This helps them in giving a proper feasibility report regarding the sites and also plan for a faster recruitment. The SMOs keep their study staff in continuous monitoring of the study subjects to assess the SAEs and prevent a follow up loss. Often the coordinators are given patient assessment charts to monitor the symptoms by phone before the next visit is planned. Retention of subjects, which is one of the major challenges in India, is overcome by continuous reminders and calls to the subject by the study coordinators. Another major offering from the SMOs is providing the administrative support to the investigator. The study staff is trained with responsibilities of preparing and maintaining informed consent documents, subject case histories, assisting the investigator to conduct research in accordance with the protocol, data entry, maintaining study records, regulating disposition of the study drug/device13 and assisting in project close-out documentations thus reducing the work of a PI. A central contract with its investigators and various sites enables the Multi site SMOs to play a vital role in bringing together the various potential sites and investigators all over the country, thus providing research support to tier-2 cities. Multisite SMOs have the bandwidth for selecting the most appropriate investigators and sites on a study to study basis. Thus by interacting with several potential sites, they are free to select the sites according to the protocol requirements. An SMO with these attributes will be a sponsor's ideal partner to work with. Challenges of CROs It has not been a smooth ride for the sponsors to perform their trial related activities. While the dearth of skilled staff and trained investigators continues to be a hindrance, the ethics committee formalities remain a major challenge. Experienced sites being limited to urban areas and with several projects already on hand, the investigators have always faced a problem with more incoming studies. It has been estimated that there are only about 1,000 experienced investigators available in the country, and there is a need for many more who understand the ICH-GCP, DCGI guidelines and the protocol specific requirements. Some of the major issues during the study have been retention of subjects due to lack of regular follow-up, protocol adherence and the data quality. Delays in recruitment have always been a concern in meeting the stipulated timelines. Moreover the time spent on documentations and data quality by the investigators themselves with inexperienced site staff impaired and delayed several studies. Giving the impetus SMOs have made an enormous difference to overcome several hurdles throughout the study, reassuring the market escalation. Both the pharma majors and CROs would greatly benefit working with SMOs for a more efficient research thus bringing an extensive cost advantage. The much apprehensive data quality standards and time factors can be reassured further by working with these SMOs. With over 16,000 hospitals, 500,000 doctors and 270 medical institutions, there is a major scope for these SMOs to expand their network throughout the country reaching out to the tier-2 cities. The views expressed herein are the personal views of the authors and do not necessarily represent the views of the company they represent or any of its member firms.   ]]> <![CDATA[Increasing the chances of clinical trial success in India]]> https://biospectrumindia.com/news/95/2399/increasing-the-chances-of-clinical-trial-success-in-india.html https://biospectrumindia.com/news/95/2399/increasing-the-chances-of-clinical-trial-success-in-india.html Wed, 10 Sep 2008 11:58:00 +0530 New Page 1 Increasing the chances of clinical trial success in India Drug development has shifted from being discovery constrained to development constrained. Dr Anand Bidarkar He is Vice President, SIRO Clinpharm Pvt Ltd and a well known clinical research expert and an international speaker on issues facing the Indian CRAMS and biotech sector. The development of new discovery and development technologies has significantly accelerated the search for new drugs to combat disease. The rapid identification of potential leads has led to an increased demand for clinical development resources. For the first time in history, drug development has shifted from being discovery constrained to development constrained. The recent safety issues with a number of drugs on the market has further aggravated the situation with regulators asking for greater evidence from clinical trials before approving new drugs as well as insisting on continued testing post approval. Constraints in clinical R&D are driving up the costs and time to market of potential new drugs. Recent statistics indicate that over 80 percent of clinical trials in western countries are delayed for various reasons most prominent among them being slow patient enrollment and availability of trained resources. The pharmaceutical and the biotech industries globally are in the process of exploring new geographical options to overcome the bottlenecks in the traditional areas. India has emerged as an attractive new destination for conducting clinical trials as well as other related activities like data management, biostatistics and medical writing. All the top 10 pharmaceutical companies have an active clinical trials program in India and according to data released by the planning commission in April 2008, the volume of trials in India is greater than in China. The promise of faster trials at economical costs is attracting a large number of companies to India, while many of them benefit from the move, an increasing number fail to gain any advantage. This not only affects the plans and fortunes of the company and the CRO executing the project, if involved, but also brings a bad reputation to the industry as a whole in India. The reasons for the failure in many cases can be traced back to the trial planning or award stage. The boom in the clinical research industry has led to mushrooming of a large number of clinical research organizations (CROs). Many of these startups have only a rudimentary knowledge and capabilities of project execution in clinical research. The lack of understanding coupled with the desperation to land business leads to unrealistic delivery commitments and costs a sure recipe for failure. A number of pharmaceutical and biotech companies outsourcing their trials to India often get carried away by the hype of speedy patient enrollment. While it is well documented that India does offer these advantages, the quantum varies significantly and is based on multiple factors including the therapeutic area, site selection, and recruitment practices. These companies often fall for proposals that quote a high patient enrollment rate and do not delve in to details of suggested figures. A structured feasibility is fundamental to drafting a project execution plan with the right enrollment estimates. Many companies, including CROs and biopharmaceuticals compromise this process. The tight deadlines for submission of a proposal mean that this process is accomplished in a tearing hurry with inputs taken in haste from the first available investigators. This is very often not a true representation of what is achievable once a trial is initiated. Poor feasibility ranks among the top reasons for project delays and failure. The enrollment rate is a critical component of the proposal; it determines not only the total project duration but also the number of patients that can be sourced from a particular country as well as the cost. Companies should ensure that the feasibility is carried out in a transparent and well defined manner; there is no undue pressure to quote unrealistic enrollment rates and there is a meaningful discussion on the feasibility estimates before the award of the contract. The second reason for the failure of projects is the overt emphasis on costs. Companies looking to base their clinical projects in India need to realize that due to the nascent stage of the industry in India many cost conserving measures used in the western countries like optimizing the monitoring frequency and project manager co-monitoring can prove to be counter productive in India. A majority of Indian sites require continuing guidance and frequent monitoring to carry out patient enrollment as per plan and more importantly ensure compliance to GCP guidelines. The average experience of Indian CRAs is about 1.5 to 2 years and though they are quite competent in their basic understanding, many of them require a greater degree support from their project managers in comparison to the west. There is also a need for a greater degree of therapeutic area and protocol training and this should not be compromised in an effort to reduce cost. In most instances, travel in India takes up greater duration of time than in the west for comparative distances; this can impact the time available to a CRA for site monitoring on outstation day trips and a stay over might be required. Sponsors and CROs that overlook these factors in an attempt to save costs suffer quality and enrollment issues. Before companies award projects they should carefully evaluate the project execution plan to ensure that sites and the CRAs are adequately supported. CROs that overlook these issues can often provide quotes that are up to 20-30 percent lower, taking this up at face value often means being penny wise and pound foolish. Companies conducting their clinical trials in India also need to suitably adapt their standard operating procedures to suit the Indian conditions. This is helpful to ensure compliance at all levels as well as for the successful conduct of the project. Lack of adequate site knowledge is another significant factor leading to project failure. Site knowledge influences compliance, budgets and eventually timelines and quality data. Sites in India has very little experience of clinical trials, many of those that have the experience are saturated with multiple trials. Many companies also report delays due to administrative procedures at the site. Companies should ensure that sites are evaluated in depth at the feasibility and the site qualification stage. All sites that are included in the trial should undergo a Gap analysis and a strategy should be in place at the project commencement stage to deal with the gaps at the site level. This can go a long way in ensuring the success of the project. While India's growth as a clinical research destination is backed by strong fundamentals, it is also critically dependent upon successful project execution in terms of timelines and quality. While the issues discussed above are not comprehensive and there are several other factors that can contribute to the fate of a project, a careful consideration of these can significantly enhance the successful conduct of a clinical trial in India. Companies operating in the clinical research space need to consider these factors carefully for the continued growth of the industry in India. The views expressed herein are the personal views of the authors and do not necessarily represent the views of the company they represent or any of its member firms.   ]]> <![CDATA[Planting hope, harvesting fuel]]> https://biospectrumindia.com/news/95/2207/planting-hope-harvesting-fuel.html https://biospectrumindia.com/news/95/2207/planting-hope-harvesting-fuel.html Wed, 10 Sep 2008 11:54:00 +0530 New Page 1 Planting hope, harvesting fuel A humble desert plant named Jatropha has been receiving much attention lately, raising high hopes for the future. Jens Hartmann The author is Country Head India and Head, Bayer CropScience South Asia. Born in Wuppertal, Hartmann pursued his early education and advanced academics in Germany. In October 2004, Hartmann took up responsibilities in India as the Chief Operating Officer, Bayer CropScience Ltd. Offering a wide range of applications, the hardy shrub's potential sounds more than promising. Jatropha can revive barren grounds, create jobs from virtually nothing, help small farmers in emerging countries to escape poverty, and it can even provide renewable energies. This particular oil well holds a lot of future promise. Jatropha nuts can provide high-quality biodiesel per hectare. Refined Jatropha oil can be used for diesel motors with just minor modifications to the engine. What is more, the fuel is clean and environmentally friendly, offers an outstanding CO2 balance and can thus contribute to protecting the climate. How it all started The pioneer country of the Jatropha campaign is India. This is where, in 2003, an enterprising project woke the hardy shrub from centuries of inconspicuous slumber. Agricultural researcher Professor Dr Klaus Becker of Hohenheim University in Stuttgart, Germany, initiated the project together with Daimler Chrysler. Jatropha was cultivated in trial plantations in the Indian state of Gujarat, refined locally and used in test vehicles in early 2004. In April-May 2004, a modified Mercedes Benz C 220 CDI went on a 5,900km-tour through India, receiving worldwide publicity. The Indian government has also come to realize the economic advantages of the succulent shrub bearing the scientific name of Jatropha curcas. So far, India imports 70 percent of its oil, an increasingly costly item in the country's budget. Reducing the country's dependence on fossil energy sources is therefore high up on the political agenda. By 2011, the government plans to substitute 20 percent of the country's diesel consumption, and Jatropha is officially rated as the most important alternative fuel source. Stopping erosion Inexhaustible oil source, environmentally-friendly energy supplier, and a job generator, the plant offers all that and even more. According to Professor Klaus Becker it is even able to heal degraded surfaces: "We are planting Jatropha on wasteland to stop erosion. We hope that in 10-15 years time we might be able to recuperate these areas." Even the crop's by-products might be useful. Once the oil has been extracted from the Jatropha nut, the remaining press cake can be used as animal feed. The quality of the Jatropha flour is significantly better than soy, Professor Becker explains. "The only problem we haven't solved yet is how to extract the poison. But I'm sure we will work something out." The poison itself could also be marketed. So far, Jatropha is still a wild plant that needs to be domesticated for cultivation. But researchers, industrialists and politicians worldwide are increasingly interested in the energy plant with its promising potential. The Indian government has selected Jatropha as a potential source for biofuels. There are both public and private initiatives on Jatropha in India which have resulted into approximately 0.3 million hectares of plantations. Cultivation thus falls way short of the government's projected target of 2.2 million hectares of Jatropha already by 2006. The plant can be grown on some of the estimated 60 million hectares of waste and marginal land including degraded forest land, but experience shows that a minimum rainfall of around 500-700 mm is needed to fully exploit the yield potential. Bayer activities with Jatropha in India There are currently a couple of multinational companies engaged in Jatropha cultivation for biofuel production. Bayer CropScience is also looking intensely to become a partner of choice when it comes to professional crop protection for Jatropha. The development of Jatropha from a wild plant to a plantation crop requires professional input including the management of pests, diseases and weeds. And Bayer CropScience is ready to support this development with all its expertise in order to find tailor-made solutions for Jatropha production. Food production takes priority Cultivation on poor or degraded soils is in the focus also for the Chairman of the Board of Bayer CropScience, Friedrich Berschauer : "Biofuels certainly make a contribution to covering the increasing global demand for energy while simultaneously lowering greenhouse gas emissions. However, "We would be well advised to also promote research into approaches that do not lead to competition in food growing," adds Berschauer. He believes that the second generation of biofuels, based on biomass and biomass residue, will play an increasingly important role here in future. Berschauer summarized Bayer CropScience's guiding principle as follows: "Food production takes priority". New jobs The Indian population will benefit from further advantages of the crop. Farming and processing Jatropha will create jobs where they are needed most: in the rural areas. The modest shrub requires little care and even less water. As it is inedible to animals, it does not need fences for protection. Its nuts cannot be harvested automatically, resulting in the creation of long-term jobs and income for the rural population. Professor Klaus Becker reckons that it takes 1.5 workers per hectare to grow and harvest Jatropha nuts. While China and India have already started planting extensive areas, Africa is planning huge Jatropha farms as well. The views expressed herein are the personal views of the authors and do not necessarily represent the views of the organization they represent or any of its member firms.   ]]> <![CDATA[Indian Agri biotech industry in credibility crisis]]> https://biospectrumindia.com/news/95/1423/indian-agri-biotech-industry-in-credibility-crisis.html https://biospectrumindia.com/news/95/1423/indian-agri-biotech-industry-in-credibility-crisis.html Wed, 10 Sep 2008 11:45:00 +0530 New Page 1 Indian Agri biotech industry in credibility crisis The debate around the safety of genetically modified crops hits a new roadblock. Jai Krishna The author is a campaigner with the environmental organization Greenpeace for the past four years. He works on Sustainable Agriculture. India is on the verge of approving its first genetically modified (GM) food crop, Bt Brinjal. Brinjal was first transformed in 2000 and has made its way clearing each regulatory step and is now in the final stages of large scale field trials. As Bt Brinjal reaches the end of the regulatory assembly line and nears the market, one issue has raised a lot of debate. Should information submitted to the regulator be kept a secret? Should that information be considered an intellectual property? Or precisely, does safety tests conducted on GM crops be reserved for private eyes of the official in the Department of Biotechnology (DBT) or the Ministry of Environment and Forests (MoEF) and not be allowed for independent public scrutiny before the approval of the product? These questions are inevitable and form the core of a legal case at the Delhi high court. The case has been filed by the biotech crop developer Mahyco and the Central Information Commission with the DBT and Divya Raghunandan of Greenpeace as respondents. Let's take a closer look at what can be an intellectual property. Intellectual property right is the provision of certain rights over the utilization of an invention to the inventor. Such rights include copyrights as well as patents and trade marks. Some of these rights, like patent rights are always given for a finite period, say 20 years. They are conferred only after a registration of the invention and in the case of a patent the process of registration also ensures the disclosure of the invention to public, while protecting the unauthorized use of the invention. Thus, the spirit of an intellectual property right is to endow benefits to the society while ensuring an incentive to the inventor. Arguments by crop developer The argument held by the industry is that while regulatory information is not an invention it has some aspects of trade secrets and thus if disclosed could affect the privacy of the individual firms and could cause commercial loss. This is not true, and the best example is pharmaceutical patents where the regulatory information, which is clinical trial data, is available after submission for any introspection, under Right to Information and similar acts across the world. The commerce is not affected in this case, because, the data by itself, even if it has sensitive information on the formulae of the production processes, is not of any use to a competitor as the utilization of that data to produce a successful marketable product requires the permission and recognition of the regulator. In fact, in the case of pharmaceuticals, the growth of inexpensive generic pharma drugs, which has brought health care to reaches of the economically deprived masses of our country, has been possible because product patents were not recognised (till 2002) by the Indian patents Act 1970. Additionally the provisions under the Drug and cosmetics Act 1940, requires only equivalence of the generic drug molecule towards an approved version of the drug molecule and permits the use of clinical trial data submitted by the inventor to approve the bio safety of the generic drug, thereby making the generic drug free of the expensive and time consuming tests required for bio safety. Such a provision does not exist in GM crop regulation because, unlike the case of a medicine where a purified form of a drug is consumed, in a GM crop, an entire organism which has been subjected to genetic modification is consumed, necessitating bio safety, as well as morphological, physiological and metabolic assessments of each variety that is genetically modified. The current regulations for GM crops, for reasons to disallow unsafe approvals and to protect the right of the technology holder of a GM crop, has already adopted the recommendations of the Sub committee for Streamlining the Current Regulatory Framework for Transgenic Crops in June 2006. It included the clause to procure an "authorization/ NOC from the technology provider in the case of sublicense" as a requirement to be fulfilled before any new Bt cotton hybrids for the Mon 531 event is approved. Thus, neither in the case of a life saving pharmaceutical compound nor in the case of a genetically modified crop, can the data submitted to the regulator for bio safety or agronomic assessments be misused. In fact such a misuse can be penalised under law. This means, the disclosure of the data for public introspection only increases the credibility and transparency of the process of regulation while in no way affecting the commercial prospects of the crop developer. Chronology of events leading to the Delhi High Court case: Feb 2006: Biosafety data of Brinjal, ladies finger, mustard and rice is sought under the RTI act by Divya Raghunandan of Greenpeace. March 2006: The public information officer, of the Department of Biotechnology, refused information under Section 8 .1.d RTI act which states "information including commercial confidence, trade secrets or intellectual property, the disclosure of which would harm the competitive position of a third party, unless the competent authority is satisfied that larger public interest warrants the disclosure of such information;" May 2006: The Appellate authority of the department reiterates the information officer's order. April 2007: The central information commission heard the case on 13th April 2007. It ordered the data to be disclosed immediately on the grounds of public interest in the issue May 2007: DBT provided only the result summaries of the data that are derived from the data for genetically modified brinjal. It directed the appellant to go to the ministry of environment and forests and take down the thousands of pages of data under supervision of an officer. There was no data given on the other three crops, (i.e) rice, Okra and Mustard. November 2007: The Central Information Commission (CIC) heard the case again on the basis of a non- compliance petition. The CIC also made an observation after going through the acts and rules related to the genetically modified organisms (under the EPA, 1986) of the fact that, "From a perusal of these rules it is quite clear that genetically engineered organism or cells are recognized by government as an item potentially hazardous to public health. It automatically follows that full compliance with these rules is a matter of public interest. In light of this we cannot agree that inspection of this information can be provided only in a restricted environment to members representing Civil Society" The commissioner ordered the DBT to provide the information within ten days in a CD format. December 2007 till August 2008: Mahyco Seeds, the developer of Bt Brinjal approached the Delhi High Court and obtained a stay on the order of the CIC on December 6, 2007. It has also has seeked to quash the order of the CIC on the grounds that: 1. The order is contrary to articles 14 and 21 of the constitution (denial of a right to hearing and make submissions) and thus does not constitute due process under law, and 2. The disclosure of the bio safety information of transgenic crops affects the commercial interests of the company as the information involves IPR. Does the Trade Related Intellectual Property Rights (TRIPS) regime of the WTO prevents disclosure of regulatory information? TRIPS does not interfere in data disclosure, provided protection against unfair commercial use is assured by governments. Article 39.3, section 7 of the TRIPS regime states Members, when requiring, as a condition of approving the marketing of pharmaceutical or of agricultural chemical products which utilize new chemical entities, the submission of undisclosed test or other data, the origination of which involves a considerable effort, shall protect such data against unfair commercial use. In addition, Members shall protect such data against disclosure, except where necessary to protect the public, or unless steps are taken to ensure that the data are protected against unfair commercial use. Three arguments emerge from this clause. One, a member country need not protect information pertaining to agribiotech but only related to pharmaceutical or agricultural chemical products. Second, the data needs to be protected from unfair commercial use and not mere disclosure; third, in any case, public interest can override the reasons to protect the data. Furthermore it is a norm that the provisions of an international treaty like TRIPS can only by read into the municipal law where there is a lacuna in the law and where the treaty does not run contrary to the municipal law in force. In this case, the RTI Act 2005 being a law in force in India is applicable to any case, regardless of the provisions of the TRIPS agreement. Does the disclosure of data affect commercial prospects of the crop? The data in question is the biosafety assessments of a transgenic crop. The contention by the industry is that the data contains protocols, event Id information, data generated under biosafety studies, methods, testing locations and the kind. Apart from the inconceivable argument that is not separable, it is quite an erroneous claim that protocols which are stipulated by the government are sensitive business information; event Id's which are anyway provided by the crop developers post the approval to the various laboratories under the Biosafety protocol and is now also one of the preconditions stipulated by the Supreme Court order for conducting field trials cannot be disclosed; methods for protein estimation and evaluation which have to be standardized methods that have been published in leading journals and accepted worldwide are actually secrets or that locations of field trials that are conducted, which need a prior permission from the panchayat or local administration officials of the area, are confidential and can affect the business adversely. If the information is not protected by the present intellectual property laws in the country, then, it's a deplorable and unethical practice of the company to provide unprotected information to the regulator for approvals and then holding the regulator ransom for disclosing information to the public. It is not the duty of the GM regulator to protect patent rights, and if the information submitted to the regulator contains patentable information, then the crop developer should approach the patent authority first to grant a patent on the contentious information and then apply for a crop approval. What cannot be granted an intellectual property right cannot be held from public disclosure under any circumstances. It needs to be noted that information has been generated for a statutory requirement under rules of the Environment Protection Act 1986 and has been submitted to the authorities under the same requirement. Thus the information is not that of the crop developer but belongs to the government specifically created and submitted to the Government for the purpose of obtaining clearances. The notion of 'ownership' of the information is a polemic argument, as the protection against unfair commercial use is anyway being guaranteed by the government. However, there is only one case where it might affect the commercial prospect of the product. If the information disclosed is found to have a faulty assessment of health and safety, then the disclosure of this might stop the commercial release of the product. But, if the product is really unsafe, then there cannot be a commercial prospect for it anyway. The debate of open access to safety test data has been growing stronger with cases of faulty assessment of drug as well as genetically modified crops. Here are two such cases which have raised doubts on the credibility of assessments by the authorities primarily because the data in question was prevented from public disclosure. Prozac, an anti depressant drug belonging to the multinational pharma giant Eli Lilly, belonging to the category of drugs collectively known as selective serotonin reuptake inhibitors (SERI's) was found to be ineffective and no better than a placebo, in February 2008. The study was done by Dr Irving Kirsch of the university of Hull and colleagues in the US and Canada. It is one of the world's best selling drugs and has been used by more than 40 million people. The study was a complete analysis of almost all data available on the drug, including the results from the studies that manufacturers chose not to publish at the time of approval. Some of the trial data were still not available for the reanalysis, and was prevented by the United States Food and Drug Administration to be disclosed under the Freedom of information Act, possibly under pressure from the industry. In April 2004, the French paper Le Monde, reported that the French genetic engineering commission (CGB) expressed safety concerns in the bio safety assessment of the maize MON 863. Following this, Greenpeace fought a case at the Cologne administrative court to access the controversial rat study MSL â€“ 18175, which was opposed by the multinational seed corporation Monsanto. In June 2005, the court ruled that the study be given to Greenpeace. An independent expert in toxicology, Dr. Gilles Eric Seralini of the Committee for Independent information and Research on Genetic Engineering (CRIIGEN), studied the report and in contrary to the European Food Safety Authority's (EFSA) decisions found kidney and liver toxicity in the rats that are fed with this maize. He later publishes a peer reviewed paper in March 2007. The fact that it took almost 19 years after the launch of the drug Prozac by the USFDA, or more than two years after the submission of the study of the Maize Mon 863 by EFSA (to merely procure data because it had been kept undisclosed by the industry, should surely not be the kind of unethical and irresponsible behaviour that we should emulate. The proposed National Biotechnology Regulatory Authority has suggested a single window system to fast track approvals by bringing risk assessment into the system with a dedicated unit. These measures, while on one side centralises decision making on a matter that has implications on matters of health, safety, trade, socio economic conditions, agriculture and ethics of the public, will raise no more than distrust in the authority if transparency and accountability for the decisions are not in incorporated. While many in the agribiotech industry may not support the position taken by the crop developer in the Delhi High Court, and might support the idea of free and open assessment by independent experts as a part of the regulatory regime, much needs to be done to gain trust on the regulator and the assessments. There are no short cuts to gain quick approvals. At the same time risking public credibility by choosing to stall a public disclosure of information at a court is the least advised route and is ill productive in the long run. The views expressed herein are the personal views of the authors and do not necessarily represent the views of the organization they represent or any of its member firms.   ]]> <![CDATA[Frontiers in insect control]]> https://biospectrumindia.com/news/95/2576/frontiers-in-insect-control.html https://biospectrumindia.com/news/95/2576/frontiers-in-insect-control.html Wed, 10 Sep 2008 11:44:00 +0530 Frontiers in insect control Frontiers in insect control The role of biotechnology in insect control-both in agriculture and public health. Dr Bharat Char The Author is Lead, Biotechnology, Mahyco Pest control programmes in agriculture and public health have relied on the use of chemicals for the past many decades all over the world. The environmental side effects of indiscriminate use of pesticides have been under scrutiny since the early 1960s when a landmark book of the 20th century,"Silent Spring", authored by Rachel Carson was published. In the last two decades, biotechnology has opened new vistas to enhance pest control that is both ecologically viable and economically sustainable, by providing tools to identify novel and improved pest control strategies. Microbial entomopathogens (pathogens that exist in nature) such as fungi, bacteria, and viruses, are effective agents for controlling pest insects. Characterization of the genomes of these entomopathogens has facilitated the identification and deployment of candidate genes in target crops by genetic engineering. The introduction of Bacillus thuringiensis insecticidal protein(s) into crop plants is a major milestone in this field. Corn and cotton are the two major crops in the world in which biotechnology tools were applied to develop insect resistance. According to a published report by Brookes and Barfoot in PG Economics Ltd (2008), corn and cotton occupy 37.3 percent of the total area planted with GM crops worldwide, second only to herbicide tolerant soybeans (58%). In India, cotton is the only GM crop commercialized and occupies 66 percent of total GM crop area in the country. The use of the insect resistant GM crops led to reductions in pesticide usage, increased farm income, improved product quality, and better human health. Insect-resistant GM crops express insecticidal proteins which include Cry proteins, Cyt proteins and Vip proteins, of which Cry proteins are most widely used in GM crops. Cry proteins are used as a single protein (eg., Bollgard cotton, YieldGard corn, Herculex I corn) or stacked with other Cry proteins (eg., Bollgard II cotton) or as a binary proteins (eg., Herculex RW rootworm corn). All of them target insects belonging to specific groups and not all economic pests are targeted by the Bt proteins. Currently, research focus is on developing resistance to sap sucking insects, stored product insect pests, finding alternatives to Bt proteins and also use the GM crop experience in managing vectors of human diseases. Here we present a few such approaches that can be used in insect control-both in agriculture and public health. Bt proteins have been exploited for almost a century, and more recently the knowledge about individual protein domains in Bt proteins is being utilized for engineering new functionalities. A domain from one Bt protein which improves insecticidal activity can be transferred into a second Bt protein to create a hybrid. Site-directed mutagenesis of coding regions and use of single construct to express two proteins (fusion protein) are other approaches. Domain engineering and expression of fusion protein enables us to express proteins from different sources and increases the spectrum of action. The Bt proteins are limited in their activity against certain groups of insects including the sap-sucking insect pests, thus necessitating the discovery of novel insecticidal genes. The characterization of insecticidal proteins, called the toxin complex (Tc) proteins, from bacteria that are symbionts of entomopathogenic nematodes, has increased the arsenal for controlling a wider spectrum of insect pests. The decoding of the complete genomes and proteomes of these entomopathogenic bacteria such as Photorhabdus sp., Xenorhabdus sp and Pseudomonas sp. (Nat Biotechnol 24:673-9 (2006)) and comparative genomics of enteric bacteria associated with insects, such as Yersinia enterocolitica, and Serratia entomophila has resulted in the identification of Tc protein homologues, which present potential alternatives to the insecticidal proteins derived from Bacillus thuringiensis. The toxin complex proteins from P. luminescens have also been transferred into plants and tested for their activity on different groups of insect pests. Genes derived from plants have shown promise for pest control by inducing antifeedant activity in target insects. These include proteins that inhibit insect digestive enzymes (trypsins and amylases) and sugar-binding lectins. The alpha-amlyase inhibitors have been specifically effective against stored product pests such as beetles and weevils. Plant lectins derived from snowdrop and garlic and expressed in rice and tobacco, were effective against sap-sucking insects. The insect genomic data is increasing at an exponential rate with genomes of 24 insect species being deciphered by sequencing. These species represent different classes of insects: model insects (Drosophila species and honey bees), medically important insects that vector serious diseases (mosquitoes transmitting malaria, yellow fever, Chikungunya and dengue fever), agriculturally important insects, subdivided into beneficial insects (honey bee-pollinator, silkworm-silk production), agricultural pests (Bollworms, Aphids, Whiteflies), and biocontrol agents (wasps). Insect genomics provides the blueprint for an improved understanding of the insect biology and behaviour and makes possible insights that could aid in finding solutions to the complex agricultural and medical challenges. As most of these data are in the public domain, access to these data and post-genomic tools will impact the innovations in pest control strategies. Gene functional studies and target discovery by genome wide loss-of-function screening using RNA interference (RNAi) is a well-established technique in insects. Plants producing double stranded RNAs (dsRNAs) directed against specific insect genes/pathways such as V-type ATPase of corn rootworm, cytochrome P450 detoxification enzyme in cotton bollworm conferred plant protection by making the insect more sensitive to plant defense chemicals. Molecular biology and genetics have been used to develop genetically modified insect strains (RIDLs - release of insects with dominant lethals) that improve the efficiency of pest control programs such as the sterile insect technique (SIT), which was used for Screwworm eradication in the Western hemisphere. An UK based company, Oxitec,UK, has been credited with this technological innovation. Field testing is in progress for Pink bollworm control in the US and mosquito control in Malaysia. Current advances in insect and entomopathogen genomics hold promise for developing novel and ecologically sustainable pest control solutions. These solutions are urgently needed for both food and health security in the developing world. Co-authors: Leela Alamalakala and Srinivas Parimi, Maharashtra Hybrid Seeds Company Ltd, Mahyco Research Centre , Dawalwadi The views expressed herein are the personal views of the authors and do not necessarily represent the views of the organization they represent or any of its member firms.   ]]> <![CDATA[Private sector in management of public health diseases]]> https://biospectrumindia.com/news/95/2387/private-sector-in-management-of-public-health-diseases.html https://biospectrumindia.com/news/95/2387/private-sector-in-management-of-public-health-diseases.html Wed, 10 Sep 2008 11:35:00 +0530 New Page 1 Private sector in management of public health diseases The private sector can play an important role in management of public health diseases. Dr Sanjay Sarin He is the National Manager (Global Health Initiative), BD India. Dr Sarin is a PhD in Biochemistry and currently heads BD's Global Health Initiative (GHI) in India. He is responsible for developing partnerships and identifying new project and business development opportunities in HIV/AIDS and TB. A significant burden of HIV, TB and malaria, the so called pubic health diseases continues to lie within the low and middle income countries. Resources for the control of such diseases are largely being made available through the public sector be it the National AIDS Control Organization (NACO), Revised National TB Control Program (RNTCP) or the National Vector Borne Disease Control Program (NVBDCP). The private sector continues to focus on the management of non-communicable diseases as this seems to offer a better return on investment. However, the changing face of health care poses new challenges for the detection, treatment, and prevention of infectious diseases especially in view of the already overwhelmed public sector which has to deal with the burden of both communicable and non-communicable diseases. The limited resources within the public health system leave it ill equipped to deal with the increasing threat of existing and emerging infectious diseases. Despite this disparity, there is now an increasing focus on the engagement of private sector in management of public health diseases. This is happening through a variety of interface arrangements aimed at leveraging the expertise of both the public and private sector in effective management of public health disease burden. There are numerous examples where the governments are engaged with the private sector to create successful partnerships. Some successful partnerships include Global Alliance for Vaccines and Immunization (GAVI), Roll Back Malaria (RBM), Stop TB partnership (Stop TB), Safe Injections Global Network (SIGN), Global Polio Eradication Programme, Action TB, International Aids Vaccine Initiative (IAVI), Medicines for Malaria Venture (MMV), Global Alliance for TB Drug Development (GATBDD) etc. Agencies like Clinton Foundation HIV/AIDS Initiative have been able to significantly increase access to both drugs and diagnostics including CD4 monitoring through 3 way partnerships with country programs and private sector entities such as BD. Likewise another NGO, Foundation for Innovation New Diagnostics (FIND), has been able to develop successful partnerships with the private sector and the WHO for the introduction of advanced TB diagnostic technologies including liquid culture systems in low and middle income countries. NACO too is trying to streamline the provision of ART services by various NGO/Trust/Charitable/PSU/corporate hospitals through a MoU approved by the Department of Legal Affairs, Ministry of Law and Justice and the National AIDS Control Board. NACO is partnering with the Confederation of Indian Industry (CII) for implementation of this initiative in the corporate sector. CII and NACO are collaborating with the private sector on introduction of HIV related work place policies, voluntary counseling and testing centers and now even ART centres. Some corporates covered under this initiative include BILT, Godrej, Bajaj and ACC. Under this arrangement, the corporate entity provisions for the infrastructure and human resource whereas NACO provides training, ARV drugs, HIV and CD4 reagent kits at discounted pricing creating a win-win situation for both parties. Likewise Global Business Coalition on HIV/AIDS, TB and Malaria (GBC) is a coalition of more than 220 companies united to keep the fight against HIV/AIDS, tuberculosis, and malaria a global priority. The Coalition's members share learnings from the front lines of the fight, and GBC provides support so that companies can take an active role in defeating the pandemics. In addition to the above, medical technological companies like BD and a few others are engaged in capacity building through delivery of advanced training programs focused on researchers, clinicians and healthcare workers. Global health agendas are today being increasingly shaped by the private sector. The resources in the commercial sector make it an irresistible partner for synergistic public health initiatives. Governments can benefit from these resources to fulfill their mandate whereas the private sector can not only play an important role in the national health agenda but also meet its social responsibility goals. Successful partnerships in the development and health sectors have clearly highlighted the need to harness the potential in collaborating with the private sector to manage and achieve public health goals. The roles, motivations, and operations of public and private sector health care organizations can be intentionally and purposefully aligned toward achieving common health goals. Though health care organizations in public and private sectors respond to different pressures but they clearly have an interest in engaging in efforts aligned with the principles of universal access to health. The views expressed herein are the personal views of the authors and do not necessarily represent the views of the company they represent or any of its member firms.   ]]> <![CDATA[Managing Knowledge Transfer in Life Sciences]]> https://biospectrumindia.com/news/95/1346/managing-knowledge-transfer-in-life-sciences.html https://biospectrumindia.com/news/95/1346/managing-knowledge-transfer-in-life-sciences.html Wed, 10 Sep 2008 11:26:00 +0530 New Page 1 Managing Knowledge Transfer in Life Sciences In the new life sciences era that is marked by convergence of scientific disciplines, technology transfer becomes an interesting challenge. Prabhu Ram The author is an IP Manager with Sathguru Management Consultants and focuses on Intellectual Property Management and Technology Transfer for the public and private sector in India, and facilitates accelerated technology transfer amongst enterprises based in India, EU and US. He can be reached at prabhur@sathguru.com It is an accepted fact that innovations emerge from the university system, and are adopted by the industry--a process referred to as "bench to bedside". As government supported institutions, there is the need to meet the expectations of the public, through new technologies, new improved processes and methods. The process through which these expectations are met is called "technology transfer". While new scientific discoveries have thrived in these institutions, there has been a lack of direction when it came to transferring these discoveries to the market. In the new life sciences era that is marked by convergence of scientific disciplines--computer sciences, engineering, life sciences, mathematics, and statistics--technology transfer becomes an interesting challenge.   Technology transfer in the Indian public research system In 2005, India adopted a product patent regime. Over the past three years, the focus in the public sector has been on patents and the need for IP protection. In 2006-2007, Council for Scientific and Industrial Research (CSIR) had a 20 percent share of the total patents granted to Indians--with 281 granted patents. These patents cover a broad spectrum--from drugs to traditional medicine to aerospace engineering. Some of the CSIR institutions were successful in transferring the technologies to the private sector. Central Food Technology Research Institute (CFTRI), Mysore, has been a pioneer in technology commercialization. In other CSIR institutions, the success has been pretty low, with occasional success stories emerging. In 2006, the Indian Council for Agricultural Research (ICAR) adopted a new technology transfer/ commercialization policy and guidelines to support the same. As part of the new policy framework, ICAR has established Institute Level Technology Management Units (ITMC) and Zonal Institute Technology Management Committee (ZTMC) to identify and nurture innovations at the grassroots level. Over the past three years, the focus has been on conducting sensitization workshops for selected scientists. It is too early to talk about successful technology commercialization stories in ICAR, except for the animal vaccines. The Indian Council for Medical Research (ICMR) and Department of Biotechnology (DBT) have technology commercialization policies in place, and some success in transferring technologies. In 2006, ICMR reported 46 technologies for commercialization by the private sector. The partnerships with Therion Biologics and Shantha Biotechnics have already been recognized as case studies for encouraging innovative collaborations with the private sector. The patent cell within the DBT has facilitated more than 100 Indian and foreign patents, of which 12 have now been granted.   Structuring industry-academia relationships Universities and public research institutions in India need to adapt to the new emerging policy environment. There is a need for the public research institutions to understand that relationships with the private sector are dynamic in nature, and never static. It is imperative to ensure prompt reporting of research results and in adhering to the agreed milestones in collaboration programmes. The private sector needs to understand the constraints under which academic scientists and research institutions work. They need to work on agreements that benefit both the parties, and work with the public sector in alleviating their fears of entering into relationships with the industry.   Concerns associated with technology transfer The current debate in India on Intellectual Property Management revolves around the "apprehensions of the private sector" and the "unchanging mindset of the public sector" towards each other. One of the hurdles for long-term relationships has been attributed to a "lack of trust" between both the sides. From the inner looking mindset of the public sector in the 1990s and earlier, the new policy initiatives at the public research system hold promise. It is an acknowledged fact hat collaborations are the step forward for the public sector system. As recent success stories demonstrate, the public sector is taking healthy strides to translate basic research into success stories. While patent filings have been on an increase, the true success of judging the IP lies in how many of these patents translate into successful technologies. This is especially true for CSIR, and it remains to be seen on how it goes about commercializing its vast patent portfolio.   Facilitating knowledge transfers in India In 2005, CSIR, ICAR, ICMR and DBT established a forum to engage in critical dialogue on technology transfer. The Society for Technology Management (STEM) has, over the past three years, seen more than 100 new members joining it. Apart from the Indian public research system, the STEM today includes membership from public research systems from South-East Asia and the Middle East. It also includes membership from leading life science companies in the United States, Europe and India. Many scientists from the public sector have acknowledged the role of STEM in enhancing their IP awareness and of their knowledge in technology licensing, licensing agreements, and dissemination of research results. The STEM is currently engaged in developing metrics for technology transfer in Asia, with a key focus on India.   Future Steps Some key steps that need to be taken include: Generating a broad research dataset that establishes critical linkages along the discovery-to-commercialization continuum for establishing critical benchmarks. Minimizing bias in industry sponsored research, by prompt ddisclosure of the source of research support in scientific publications and conferences. Formulating conflicts of interest policies at the institution level. IISc and IIT Bombay have such policies in place, as part of their IPR Policy. Identifying key issues and challenges around technology transfer and commercialization, and help define India's policy position. Active collaboration amongst our apex research organizations--CSIR, ICAR, and ICMR to review their institutional policies and best practices, and identify ways to enhance their impact in technology transfer. Benchmarking best practices, active processes, success stories, will help make technology transfer and commercialization happen better, faster, and with fewer obstacles. For the benefits of academic-based life-sciences research to percolate to the common public through effective knowledge transfer mechanisms, steps need to be taken to address concerns regarding: current scientific research priorities, structuring academic-industry relationships, and above all, the policy initiatives and enabling mechanisms for technology transfer. Addressing these concerns will ensure that the public funded research realizes its full potential, and justifies the huge public investment. Sathguru Management Consultants is the chosen partner for CSIR, DBT, ICAR and ICMR, and continues to work with them on framing policies and for successful transfer of technologies to the marketplace. Sathguru is a pioneering technology consulting firm with key expertise, many successful stories, and over twenty six years of experience in technology transfer in South and SE Asia. As the only such firm in South Asia, Sathguru works closely with the public and private sector in identifying, nurturing and managing successful knowledge transfers, and has over 30 tech transfer success stories in the past decade. Currently, Sathguru is in advanced stages of commercialization for 5 technologies from the public research system. It is also engaged in in-licensing of new technologies for ICAR. The views and opinions expressed here, and any errors therein, are solely those of the author and not necessarily reflect the views of Sathguru.   ]]> <![CDATA[India Poised for Rapid Expansion and Globalization]]> https://biospectrumindia.com/news/95/2166/india-poised-for-rapid-expansion-and-globalization.html https://biospectrumindia.com/news/95/2166/india-poised-for-rapid-expansion-and-globalization.html Wed, 10 Sep 2008 11:26:00 +0530 New Page 1 India Poised for Rapid Expansion and Globalization India is the world's second and fourth largest supplier of childhood vaccines and pharmaceuticals, respectively, and the same potential lies for the biopharmaceutical segment, with a strong focus on follow-on biologics. Dr Rustom Mody The author is Director (Quality & Research), Intas Biopharmaceuticals Ltd. He has over 11 years of experience in the pharmaceutical industry working with two pharmaceutical companies as a Project Leader and later Project Director for the commercial production of recombinant vaccines. He can be contacted at rustom.mody@intasbiopharma.co.in The focus within the biopharmaceutical sector in India is directed more towards development of follow-on biologics. This is primarily because it requires much lower risk, R&D spend, and time to market. Under the TRIPS agreement, the pre-1995 product patents do not apply in India. This leaves a big number of drugs, patented prior to 1995, marketable in India. For some drugs, the innovators have not sought patent protection in India; creating a strong opportunity for Indian companies to leverage the huge domestic market to their advantage. For example, Intas Biopharmaceuticals Ltd is the first company in the world to have launched a biosimilar PEG-G-CSF (NEUPEG) after the innovator. The company is also the first in India to be approved by EU-GMP. The company is strongly focusing its R&D efforts through partnerships for launching its biogenerics in Europe and the US and is building capabilities to expand its CRAMS business. With over 130 homegrown biopharmaceutical companies, many of which are fully integrated, the global market for Indian biopharmaceutical companies have touched $1.5 billion in revenues in 2006 with compounded annual growth rate (CAGR) of 27 percent. Factors influencing rapid growth include large population with high consumer base (300 million) comprising of middle and upper income groups, a third of which can afford private healthcare and specialty therapies, making India the 11th largest pharmaceutical market in value terms. Also included are factors such as regulatory and health care reforms (22 percent increase in government spend, 200 clinical trial approvals in last three years), and the ability of biopharmaceutical companies to reverse-engineer the drug development process. With the enforcement of the product patent regime in 2005, the skill sets have fast progressed from reverse engineering of drugs to research and development of novel drugs. In terms of quality, depth of services, range of products and capabilities, it is comparable to any global biopharmaceutical company. India is currently the second largest manufacturer of childhood vaccines in the world. Here again the key factor is lower cost of infrastructure (about 10-20 percent the cost of a comparable plant in the developed countries), lower manufacturing cost supported by highly skilled low cost professionals in various service sectors such as clinical research organizations, bioinformatics, manufacturing and support. As per the latest estimates, the average cost saving for R&D is 60 percent and that for manufacturing is 35 percent of the cost in the developed markets. This has also been the reason for many biotech companies entering the Contract Research and Manufacturing Services (CRAMS) business. This business has shown a healthy CAGR of 37.6 percent and is expected to touch $1 billion in revenues by 2010. India, with its potential to generate high out-put value per dollar spent, has been an attractive destination for several global companies to set up a R&D base in India or tie-up with Indian companies in order to lower the drug development cost. Measures that are fuelling the rapid growth of the sector include: increase in biotechnology incubators and parks, venture capital, fiscal incentives and tax benefits, speeding up of regulatory approvals, active role of Indian Pharmacopoeia in issuing product specific monographs on major biotherapeutic proteins, and soon to be developed the much awaited single window drug clearance through the National Biotechnology Regulatory Authority (NBRA). The views expressed herein are the personal views of the author and do not necessarily represent the views of the company they represent or any of its member firms.   ]]> <![CDATA[Technology & More ...]]> https://biospectrumindia.com/news/95/2535/technology-more-.html https://biospectrumindia.com/news/95/2535/technology-more-.html Wed, 10 Sep 2008 11:19:00 +0530 New Page 1 Technology & More ... The story of emerging technologies in healthcare is the boom that was waiting to happen. What was considered special and innovative some 30 years back is now regarded as healthcare's daily tools. Suresh Vazirani Vazirani is Chairman & Managing Director, Transasia Bio-Medicals Ltd. He founded the diagnostic company back in 1979, which is today present across 55 countries. He can be contacted at s.vazirani@transasia.co.in Bigger budgets and stress on research and development are now allowing for newer technologies in manufacturing, communication and networks. There are many advantages of introducing newer technologies on the job to reduce turnaround time and lower costs without compromising on the quality. Additionally, public awareness initiatives across the globe are facilitating the uptake of new technologies and highlighting the value of IVDs in the improvement of medical care.   Molecular diagnostics Advances in certain technologies have provided us with an understanding of mechanisms of disease at a molecular level. This can now be translated into diagnostic, prognostic and therapeutic tools. Molecular Diagnostics covers current molecular biological techniques and procedures to evaluate infectious disease, inherited disorders, cancers and other gene abnormalities. Techniques include the use of PCR, DNA hybridization, RFLP, blotting techniques, fluorescent in situ hybridization (FISH), second-generation biochips and microfluidics, next-generation signal detection, biosensors, and molecular labels. Propelled by factors such as increasing prevalence of several chronic and infectious diseases, emerging technologies and increasing patient awareness, the IVD market is particularly characterized by the emergence of various novel technologies like Molecular diagnostics which is expected to play a very important role in driving the future growth of the industry. In particular, the evolution of molecular diagnostics expects to have a significant impact on patient success rates and overall healthcare cost reduction. New disciplines A combination of new disciplines, such as genomics and proteomics, has now given molecular diagnostics new technologies. Genomics is the study of all the genes in a cell or organism, while proteomics is the study of all the proteins. Molecular diagnostics determines how genes and proteins interact in a cell, focusing on the activity patterns in different types of cells to uncover changes. These "expression patterns" of intracellular activity help to diagnose an existing condition such as cancer, or warn of a possibility or probability of contracting a particular disease. This has been used extensively in personalised medicine which uses genotyping to predict an individual patient's response to a particular drug. It also includes any test that guides, modifies, or customizes treatment of a specific disease in a patient. For example, a genetic test for BRCA mutations can indicate an increased risk for developing breast or ovarian cancer. With this knowledge, physicians and patients can take preventive actions to mitigate that risk. The largest market in the molecular diagnostics segment is currently infectious-disease testing. This is due to the fact that infectious diseases present a major market opportunity in terms of incidence and that the genetic information required for identifying pathogens is readily obtained from the bacterial and viral species involved. Gene and chromosome testing also represents a large segment of the molecular diagnostics market segment. At this point in time, most genetic testing is prenatal testing for assessing clinically suspect newborns for various chromosomal abnormalities. Prospects for India The molecular diagnostics market has an encouraging outlook for India. First, the economic boom in India has led to a striking increase in purchasing power among the middle- to upper-tier economic groups. Thus, although disease-screening programs are largely at an embryonic stage, the shift in economics and attitude provides for a more encouraging outlook in terms of the success of such efforts in the future. Second, the arrival of multinatonal corporations in large numbers to the Indian scene has been accompanied by a similar growth in indigenous corporate entities where employee health issues are of increasing importance. A parallel development has been the progressive expansion of health insurance programs that cover curative, diagnostic, and health screening programs. The third encouraging facet of the demographic shift in India concerns NRIs. Returning NRIs are accustomed to having regular medical checkups and know well the value of preventive medicine from their stay in the West. These facts, combined with the age and purchasing power of NRIs, represent a significant and growing market for cutting-edge tests. Innovations in molecular diagnostics continue to advance the state of medicine, however there is an increased need for automation. Many IVD companies have introduced smart platforms that depend less on highly skilled medical technicians and more on technology. There is also a growing awareness of the need for knowledge-based software that can transform laboratory data into valuable information that directly affects patient management. Significant technical obstacles must be overcome before proteomics and pharmacogenomics (targeted drug therapy by taking account of an individual's genetic makeup) can make the transition from the laboratory bench to the clinical laboratory and patient bedside. Outlook This specific segment of the in-vitro diagnostics market called molecular diagnostics is expanding in important areas like viral load monitoring of HIV patients. The current trends and future outlook for this segment are excellent for the worldwide market. The detection of predisposition to lifestyle disorders and underlying genetic factors that may contribute to eventual disease onset are correspondingly important factors in long-term (chronic) health care management. With the breakthroughs in molecular diagnostics and advances in laboratory equipment, this piece of the diagnostics pie is going to play an increasingly large role in early diagnosis, monitoring, and targeted pharmaceutical intervention. The views expressed herein are the personal views of the authors and do not necessarily represent the views of the company they represent or any of its member firms.   ]]> <![CDATA[Paving way to commercialization of Mesenchymal Stem Cells]]> https://biospectrumindia.com/news/95/4359/paving-way-to-commercialization-of-mesenchymal-stem-cells.html https://biospectrumindia.com/news/95/4359/paving-way-to-commercialization-of-mesenchymal-stem-cells.html Wed, 10 Sep 2008 11:18:00 +0530 New Page 1 Paving way to commercialization of Mesenchymal Stem Cells The business model of "Off-the-Shelf" products in the stem cells arena is slowly but steadily unfurling. Dr Jyoti Kode Dr Kode is Scientific Officer "E" at Chiplunkar Lab, Advanced Centre for Treatment, Research & Education in Cancer, Tata Memorial Centre, Navi Mumbai. Being immunologist and biotechnologist, she keeps herself updated with stem cell market trend and commercialization of cell-based products. She can be reached at jkode@actrec.gov.in Various in vitro studies and studies in animal models have undermined the feasibility of transplanting Mesenchymal Stem Cells (MSC). Over a decade ago, Haynesworth et al successfully isolated, expanded human MSC and demonstrated a reliable in vivo bone-forming assay. Next step was to evaluate the safety, feasibility, and efficacy of transplanting "off-the-shelf" MSC for clinical trials. In vivo models have demonstrated that MSC can engraft into organs like liver, bone, lung and kidney. In a canine model, transplantation of autologous MSC with partially demineralized bone matrix restored bone defects and enhanced bone growth in non-weight-bearing gap. This combination provided an option for reconstructing bone defect while performing a cementless revision arthroplasty. These properties have led to the suggestion that MSC may have a role in tissue repair and regeneration. Major setbacks Some guidelines in the widespread clinical exploitation of MSC are being formulated by ISCT. One major problem is the lack of a commercial Good Manufacturing Practice licensed MSC product. There are no generally accepted assays of the potency of MSC, and the optimal route of MSC delivery must be defined for individual indications. The best MSC source, its purity and the optimal dose remain to be specified. Purity, also defined as the identification and presence of "contaminating" cell populations, is critical because the degree of contamination may affect both the biological effects observed as well as the potential side effects. Quantification of all of these factors will be required to obtain a reproducible and consistent cell preparation that could potentially be used in clinical studies. Safety issues are a concern, although injection of syngeneic, allogeneic and xenogeneic MSC into immunocompetent mice is tolerated without apparent side effects. Despite the heterogeneous nature of stromal progenitor cell populations, a consensus concerning the definition of MSC and Good Manufacturing Practice protocols are evolving. Stem cell market This is the dynamic area of biotechnology that is experiencing significant growth after monoclonal antibody therapeutics market. Investors are bullish on stem cell products that have application in treatment of diseases that cannot be cured by non-cell products. Adult stem cells market is the largest tapped market while cord blood and embryonic stem cell markets, though with huge market potential, are still in infancy stages. The US is the leader followed by the European and Asia-Pacific regions. With government regulations being amended in several countries, stem cell research is expected to pick up pace rapidly in the next few years. India is expected to have a market share of about $540 million with an annual growth rate of 15 percent. There are about 180 stem cell companies in the world. The market potential of this technology is so huge that revenues may be in excess of $10 billion by 2013 (www.StemCells.Net). The potential of stem cell research â€“ both medically and economically, is leading to huge investments by biotechnology companies, pharmaceutical companies and governments too. Commercialization Various biotechnological companies have developed patented formulations of adult stem cells and evaluated safety in Phase II/III clinical trials for treatment of acute GvHD, Crohn's disease, Type I diabetes, cardiac failure, long bone defect, non-healing wounds/burns etc. Their focus is to progress through clinical trials and international regulatory processes necessary to commercialize the technology in as short a timeframe as possible. Osiris Thearpeutics Inc., Columbia, MD, USA (www.osiris.com) has developed "Prochymal" for treatment of patients with cardiac dysfunction, acute GvHD, Crohn's disease and Type I Diabetes. Osiris recently received contract by defense department, worth $224.7 million for development of Prochymal for treatment of Acute Radiation Syndrome. Mesoblast (www.mesoblast.com) is an Australian biotechnology company committed to the development of novel treatments for orthopedic conditions. Mesoblast's high margin business model, allogeneic or "off-the-shelf", products is to develop clinical products using allogeneic or "off the shelf" adult stem cells. Consequently, Mesoblast's cells obtained from a single donor can be used to treat thousands of unrelated patients. This results in an efficient, highly reproducible product, with low manufacturing costs that can generate high margins akin to pharmaceutical sales. Equally as important, such "off-the-shelf" products will be available at hospitals for immediate use by orthopedic surgeons when the acute trauma or other injury needs rapid treatment. Mesenchymal stem cells (MSC) are unspecialized cells that lack tissue specific characteristics and can maintain their undifferentiated phenotype. Minimal criteria for defining multipotent MSC, according to the International Society for Cellular Therapy (ISCT) are the ability to regenerate and differentiate into tissues of mesodermal origin (osteocytes, adipocytes and chondrocytes), and the absence of expression of haemopoietic molecules CD34 and CD45. Mesenchymal stem cells characteristically express SH2 (CD105) and SH4 (CD73) and Thy-1 (CD90) antigens. MSC can be derived from bone marrow, bone, fat and placenta. They can be easily isolated in culture and have high "ex-vivo" expansion ability. Therapeutically MSC are attractive because they do not require matching with recipients. They lack HLA-DR molecules, which make them immune-evasive, and moreover they are known to suppress innate and adaptive immune response. MSC have elicited a great clinical interest in form of allogeneic or "Off-The-Shelf" product or "universal donor cells", particularly in the areas of regenerative medicine and induction of tolerance in allogeneic transplantation. Mesoblast Inc. has invested up to $17 million into US-based sister company Angioblast Systems Inc., NY, USA (www.angioblast.com). In alliance with Abbott, a global healthcare company (ww.abbott.com, investment of $5 million), Angioblast has entered into development and commercialization of catheter-based therapy of heart failure. Harvest Technologies Corp. has announced BMAC System to treat patients with non-reconstructable critical limb ischemia at Shri Ramachandra Medical Center, a Harvard Medical international-associated institution based in Chennai, India (www.harvest-tech.com). Harvest's BMAC System is a device to harvest, process and deliver patient's own bone marrow stem cells all in the same procedure. The study is designed to treat patients suffering from advanced thromboangitis obliterans, commonly referred to as Buerger's Disease. The early clinical results have looked extremely promising. Gary Tureski, president of Harvest Technologies said. "When this study's data is combined with data from our ongoing multi-center FDA study in the US, these results will offer us the opportunity to demonstrate the potential for BMAC to be an effective treatment for Critical Limb Ischemia regardless of the underlying cause." In flow with innovations in the anti-aging market, British biotechnology company Intercytex has announced the release of an injectable filler that is said to improve facial wrinkles. Intercytex has also recently created waves with the creation of artificial human skin ICX-SKN. The off-the-shelf skin replacement product is said to be revolutionary for patients affected by burns and skin damage, with the cosmetic implications beneficial for consumers who wish to avoid the painful process of skin grafts. Cytori Therapeutics, San Diego, CA, USA (www.cytoritx.com) has successfully commenced marketing of Celution 800 system which provides patient's own adipose-derived tissue derived stem cells at the bedside. These cells are easier to extract compared to drilling hole for bone marrow. Moreover, the Celution System is a closed device that circumvents the need for GMP-clean room for cellular expansion/ manipulation and allows easy purification of stem cells at the point-of-care. The devices are now being sold into the growing international reconstructive surgery market for so-called cell-enhanced reconstruction. This product received distinct awards of year 2008 from two top-most organizations recognizing high potential of Celution 800 platform to dominate practice of regenerative medicine. CJ CheilJedang (www.CJ.net), a healthcare company from South Korea has invested up to US$ 2.5 million in Neuralstem, Rockville, MD, USA (www.neuralstem.com) for commercializing stem cell products & technology. Organogenesis Inc., Canton, MA, USA (www.organogenesis.com), with revenues of $55 million in 2007, is focused on skin regenerative medicine products. Its signature product "Apligraf" is used to treat patients with diabetic foot ulcers and venous leg ulcers. Software companies too are exploiting market opportunities in stem cell therapeutics field by building software that help to ensure quality, regulatory compliance standards are met and integrated with established procedural protocols, monitoring manufacturing processes and documenting lot-to-lot traceability. The software StemLab also provides all the tools needed to comply with GMP and regulatory requirements for documentation of identity, purity and potency of products (www.stemsoft.com). This software is introduced to meet the need of researchers and clinicians involved in stem-cell based processing, manipulation & therapies. Stem Cell Bioprocessing is being developed in the UK in partnership with system engineer, expert on bioreactors and cell encapsulation technologies for the successful transfer of laboratory-based practice of stem cells and tissue culture to the clinic as therapeutics, through the application of engineering principles and practices. It aims to have products which are cost effective, rapid in outcome, robust, reliable and reproducible. Based on studies conducted to date, the adult stem cell therapies provide a safer approach at curing and treating neurodegenerative diseases, cardiac failures, burns, bone defects, etc. than competitive therapies that rely on embryonic stem cells. This approach to stem cell therapeutics, using adult stem cells, eliminates the additional risk factor of teratoma formation that embryonic stem cell treatments face. It is expected that this will pave way to faster commercialization of MSC-based products than competitor stem cell products such as ES or iPS cells. Co-author: Shayanti Mukherjee The views expressed herein are the personal views of the authors and do not necessarily represent the views of the organization they represent or any of its member firms.   ]]> <![CDATA[Future of the Indian BioPharma Industry]]> https://biospectrumindia.com/news/95/1404/future-of-the-indian-biopharma-industry.html https://biospectrumindia.com/news/95/1404/future-of-the-indian-biopharma-industry.html Wed, 10 Sep 2008 10:52:00 +0530 New Page 1 Future of the Indian BioPharma Industry The Indian BioPharma industry has been witnessing a double digit growth over the last few years. The focus in the past was on generics, reverse engineering, and exports. The drivers now are domestic markets as well as international markets, contract manufacturing and research to a limited extent. Hitesh Sharma, Partner & Leader, Health Sciences Practice, Ernst & Young The author is Partner and National Leader Health Science practice at Ernst & Young. He specializes in International Tax and Transfer Pricing and has worked on several international acquisitions, investment structuring assignments and cross-border tax efficient structures. Email: hitesh.sharma@in.ey.com While the BioPharma industry is having moderate to good growth depending upon the sub-segments, there is a huge potential in India waiting to be unlocked. Globally, the Indian pharmaceutical industry is ranked fourth in terms of volume. However, it ranks 14th by value. Per capita spend in India on healthcare is $9 and is very low compared to that in other developing economies such as China, Brazil and Russia where the spending is $17, $72 and $59 respectively. These factors further firm up the belief about the potential success story of BioPharma industry in India. Increase in the size of the domestic market will be a major contributing factor to this growth. There are several factors which would contribute to increase in the size of the market. A key factor would be the rising per capita income, which has and would lead to greater affordability of drugs. The awareness about health insurance in India is on the rise too. This is likely to spur the demand for healthcare infrastructure, drugs, and facilities manifold. Medical tourism is also getting increasingly popular. However, it is still expected that a bulk of need and demand would lie in the semi-urban and rural areas. These would also call for advanced technological and monetary investment in the supply chain networks to provide accessibility to drugs and treatments. Urban areas on the other hand are likely to see greater incidences of chronic and life style diseases, leading to need and demand for effective therapies to treat these diseases. For catering to this growth and living up to the expectations of economic and social responsibilities, the BioPharma industry will have to take up numerous challenges and responsibilities on its way, many of which could be different and in contrast to the current or past practices. One of the key factors that would help the sector to live up to the promise it holds and achieve a long-term sustainable growth on a global scale would be innovative research. With several products likely to go off-patent soon, almost all the Big Pharma companies are likely to lose a big chunk of revenues. Not only Pharma but also Biotech companies should learn from the present state of Big Pharma and re-look at the entire strategy for research and new molecule discovery. In this vogue, newer and emerging areas such as personalized medicines, bio-similars, nanotechnology, gene therapy and regenerative medicine will lead the way. Innovator BioPharma companies should focus on identified therapeutic segments and build portfolios on high margin products that ensure sustainable cash flows. It will be crucial for companies to march forward with high risk but promising profitable products rather than bow down under pressure from short term investors. The Indian BioPharma industry has some aces up its sleeve-the inherent low cost advantage, a strong talent pool of English-speaking scientists, entrepreneurs willing to take risks and credentials of teaming with MNCs. However, Indian BioPharma companies lack the experience to successfully launch new molecules globally and the funds to make huge investments required for innovative research-strengths of MNCs. As the Ranbaxy-GSK and GVK BIO-Wyeth deals have indicated, success would lie in synergizing the strengths and capabilities. As Indian contract research players adapt and enhance their innovation capabilities, several forms of partnerships will arise-from the existing ones as pure play research services provider to risk and reward sharing models. Such partnerships will also give enormous learning opportunities for both the Indian scientists and the marketing community. It makes clear business sense for Indian BioPharma companies as well as MNCs to take the co-optition path to synergize the benefits of their differing business models. Clearly, responsibility for daring the challenges and meeting up expectations cannot solely lie on the shoulders of the industry. On its part, the government must bring in improvements in the regulatory functions without which aggressive growth cannot be achieved. The government has taken a step in this direction with the introduction of the National Biotechnology Development Strategy in 2007. Similar focused and forward looking steps are immediately needed for the Pharma industry as well. Further, increased government funding and progressive policies to attract private equity investments will help the industry. Besides these, stronger data protection and patent regulations with greater clarity are required. Streamlining the approval process to ensure a faster turnaround is also essential. While scrapping price control measures in totality may not be feasible, certainly the government must rationalize price control regulations to enable companies to follow different pricing strategies, which will ultimately ensure better prices for customers. Increase in investments and favorable regulatory and tax policies would go a long way in upscaling the current healthcare infrastructure in India, specifically in semi-urban and rural areas. Also, companies, government and universities must come together more aggressively to formulate courses imparting practical knowledge and skills. This could be a significant contributor to meet one of the biggest challenges for industry-talent. The Indian BioPharma industry will be able to consistently grow and outperform other markets only if it can leverage these growth engines to its advantage. The responsibility is on Indian entrepreneurs and MNCs, investors who would shed the desire of short term returns and increase the appetite for long term risks, but sustained returns, and regulators and government who would create simple and effective mechanisms for immediate and sustained growth of the BioPharma industry from an access to consumer perspective. The views expressed herein are the personal views of the authors and do not necessarily represent the views of the company they represent or any of its member firms.   ]]> <![CDATA[Avenues for Indian Players in Bio-Blockbuster Drugs]]> https://biospectrumindia.com/news/95/1532/avenues-for-indian-players-in-bio-blockbuster-drugs.html https://biospectrumindia.com/news/95/1532/avenues-for-indian-players-in-bio-blockbuster-drugs.html Wed, 10 Sep 2008 10:51:00 +0530 New Page 1 Avenues for Indian Players in Bio-Blockbuster Drugs Today's Bio-blockbuster drugs are tomorrow's bio-similar drugs. Only our proactive strategy, vibrant dynamics and targeted speed could win the race of forthcoming opportunities. Dr Sanjay Kumar Singh The author is Deputy Director of Serum Institute of India Ltd. He has over 15 years of experience in managing various projects and leading several industrial platforms. He can be reached at sanjay.singh@seruminstitute.com The Indian Biotechnology industry was slow to start but is now gaining momentum. The growth of biotech segment has been phenomenal in the current decade and has finally arrived on the global scene. Indian capabilities are not to be proven as we all know the success that India has experienced in the IT sector on the global settings as it offers the cost and creative advantages over other emerging markets. There is optimism, vibrant dynamics, young enthusiasm and confidence behind a futuristic biotech vision in India. Moreover, India has a globally recognized thriving and vibrant biotech community where whole world is looking at it for joining the hand. Promise sector India shows immense potential not only as a destination for new generation biotech products but is also being targeted as a potential hub for outsourcing of clinical trials, contract research and manufacturing. Now, this segment is being observed as the latest booming sector in the Indian economy, as it is fast gaining ground to be at par with the information technology sector. India is today one of the five emerging biotech leaders in the Asia-Pacific region as reported by a survey of Ernst and Young (The Hindu; August 15, 2007). There has been a phenomenal increase in the number of start-up companies in this area in the current decade. An Ernst & Young survey, based on the number of biotech companies in the country, ranks India among the top three biotech hubs in the Asia-Pacific region, after Japan and South Korea (The Financial Express; June 08, 2007). The Indian Biotechnology sector today comprises over 340 companies generating revenues over $2.5 billion; where biopharma sector has been the major stake-holder and contributed for about 67 percent of the total biotech generated revenue (Biospectrum, Vol.: 6, Issue 7, Jul 2008). The biopharma is dominating in exports in the order of 70 percent in addition to its domestic domination of 64 percent of the total biotech sales (Biospectrum, Vol.: 6, Issue 7, Jul 2008). The biotech business is growing at a pace of 30-40 percent per annum and estimated to cross $5 billion by 2010 (ABLE-Biospectrum survey for 2006-07). The Indian biotech industry is expected to reach Rs 4,40,000 crore in 2020 (capitalmarket.com). Biotech drugs today account for 10-15 percent of the world pharma industry, and the sector is outperforming the market as a whole (Express Pharma:16-31 July 2008; Market Research.com, Injectable Generic Drugs: Prospects & Opportunities to 2010, Revised Edition). The exponential growth in the therapeutic monoclonal antibodies segment has been seen for last 4-5 years. Today, anti-cancer monoclonal antibodies segment has a highest contribution in the blockbuster drugs (R&D Pipeline News, Top 20 Biologics 2007: March 2008). The opportunities for biosimilar molecules are predicted to increase tremendously in the next decade as several blockbuster drugs are expected to go off-patent. The global markets for Indian player appear to be well positioned to leverage their cost-effective operational capabilities and compete on a global platform. With the forthcoming opportunities, Indian biopharma industry has potential to touch the mark of 20 billion in the next decade. Multi-billion blockbuster drugs (Biosimilar drugs of next decade) and their sales value in 2007* Drugs Indications Sales Value in 2007 (Millions US $) Etanercept Rheumatoid arthritis; psoriasis 5,453 Rituximab non-Hodgkin's lymphoma 5,392 Trastuzumab Metastatic breast cancer 4,743 Infliximab Rheumatoid arthritis, etc. 4,465 Bevacizumab Metastatic colorectal cancer 4,014 Darbepoetin Renal and cancer anemia 4,004 Adalimumab Rheumatoid arthritis; psoriasis 3,064 Neulasta Neutropenia 3,000 Epoetin beta Renal and cancer anemia 2,047 Insulin analogs Diabetes mellitus 8,256 * R&D Pipeline News, Top 20 Biologics 2007, March 2008. Acceleration needed Indian companies need to accelerate the selection and development of new generation biosimlar drugs, so that India could win the race of presenting the drugs to the world after their patent expiry. Indian firms are required to be geared up to upgrade the manufacturing facility and systems compliance to the standards of international regulatory agencies, such as the US Food and Drug Administration (FDA), European Medicines Agency (EMEA), Therapeutic Goods Administration (TGA) and the World Health Organization (WHO), to facilitate access to international markets not only for biosimilars but also novel protein products currently in their pipelines. Some Indian firms have proactively sensed the needs and demands of the next decade and initiated working towards the development and scale-up to manufacture such drugs for regulated markets. India already has skills and infrastructure for recombinant proteins production and now evolving into the production of monoclonal antibody based drugs. Strength from India's perspective are in strong bio-manufacturing skills with low-cost base generating high capital efficiency, established settings to assess the indigenously made biosimilar drugs comparable to the originator's products through physicochemical characterization, in-vivo and in-vitro potency evaluation, pharmacokinetic and pharmacodynamic studies, immunogenicity, allergenicity, hypersensitivity and clinical studies. Key challenges Though, India has intrinsic strengths in biotechnology, but several challenges still remain to be addressed to make India aspire to join the ranks of the truly powerful players in the world. Following are the challenges which need to be addressed. Setting up a single window regulatory clearance framework to speedup the process to commercialize the products. Though, the single window regulatory clearance is in the process but sooner we have a well-equipped statutory national regulatory body, the quicker products would see the markets. Pharmacopoeia contented with the current biotech drugs and future biosimilar drugs to be developed; Though, the government policies have been largely supportive, there is need for more innovative, creative, substantive, priority funding and the funding from venture capitalists, banks and other financial institutions that somehow seem too coy of financing biotech firms and its initiatives. Conclusively, I would say that jump to grab the visible opportunities, before hand, of getting blockbuster drugs off-patent and let India win the race on the global set. The views expressed herein are the personal views of the authors and do not necessarily represent the views of the company they represent or any of its member firms.   ]]> <![CDATA["Next Generation Sequencing technology will clearly dominate the coming decade,"]]> https://biospectrumindia.com/news/95/7775/next-generation-sequencing-technology-will-clearly-dominate-the-coming-decade.html https://biospectrumindia.com/news/95/7775/next-generation-sequencing-technology-will-clearly-dominate-the-coming-decade.html Wed, 06 Aug 2008 11:09:00 +0530 New Page 1 "Next Generation Sequencing technology will clearly dominate the coming decade," -Sanjiv P Karandikar, VP, molecular and cell biology, Labindia Life Sciences What are some of the hot emerging technologies in the cell and molecular biology space? Next Generation Sequencing (NGS) technology will clearly dominate the coming decade in terms of scientific developments. Typically, NGS platforms are looked upon as a tool to complete the Whole Genome Sequencing projects in a reasonable time-frame. With the introduction of Applied Biosystems' recently introduced NGS platform, the SOLiD System, the NGS market space has undergone substantial change. The SOLiD System is designed to perform a wide range of applications including SNP discovery, gene expression analysis, transcriptome analysis, ChIP analysis, and also offers the possibility of upgrading to a higher throughput version without hardware change. We perceive SOLiD as a complementary technique to real time PCR, microarray analysis and CE based DNA sequencing which will help scientists complete their large-scale projects at a very affordable price What have been growth trends in this space? The molecular and cell biology (MCB) division of Labindia has been growing at a rate of over 30 percent for the last four years. DNA sequencing has been our flagship product line and constitutes maximum share of MCB business. However, real time PCR is the fastest growing product line. Since the last three years, the real time PCR market has been growing rapidly and we have been successful in capturing more market share than last year. Over the last couple of years, Applied Biosystems and Labindia have identified the consumables business as one of the important "growth drivers" and it has been growing at more than 30 percent in the last two years. How much market share do you enjoy in these segments? As far as DNA sequencing market is concerned, we are enjoying a market share of more than 95 percent with a steady growth of 15-20 percent. This implies that the majority of the instruments that are bought across India are from us. In the real time PCR market, we have a market share of more than 60 percent which is growing steadily every year.   ]]> <![CDATA["India is an extremely brand sensitive market,"]]> https://biospectrumindia.com/news/95/1345/india-is-an-extremely-brand-sensitive-market.html https://biospectrumindia.com/news/95/1345/india-is-an-extremely-brand-sensitive-market.html Wed, 06 Aug 2008 11:05:00 +0530 New Page 1 "India is an extremely brand sensitive market," John Dellisanti (JD), executive vice president and chief commercial officer, and Dr Young K Yun (YY), international business director, Caliper Life Sciences. How do you see India as a market for Caliper? JD: We see Asia Pacific as a whole as a very exciting market and especially India as a high growth opportunity for us. In the past two years, we have increased our presence in the Asia-Pacific by forging strategic partnerships and making investments for the same. Our partnership with Imperial Life Sciences (ILS) is proof of our commitment to the Asia Pacific market. YY: We are providing a large number of discovery and development platforms. Our instrumentation can not only be utilized to do target validation at the drug discovery side but also at the preclinical and drug development side. Our microfluidics platform is the fundamental platform which can be adapted and utilized not only in the pharmaceutical but also in the biotech area and also by CROs and CMOs.   Why do you see India as a growing market? JD: Not only are Caliper and ILS perfectly aligned, but we are also perfectly aligned to take advantage of the emergence of the growth in R&D in India. Our product line aligns perfectly with biopharmaceuticals and bioagri sector where there is a need for high throughput experiments. The investment that India is putting into biopharmaceuticals and life sciences is what Caliper is all about. YY: Through our years of servicing the US industry, we now know what works and what does not work and hence we are in a position to help the Indian pharmaceutical and biotech industry as to how to eliminate exactly the same mistakes done by companies in the US and get onto the fast track route. Through our association with ILS in India since the past two years, we believe we are in the right place at the right time with the right partner.   How do you view the India-China race? JD: There is more opportunity and growth on the demand side in India as compared to China. China is providing tools and services while India is actually investing in pharmaceutical and biotech. So India has made an infrastructure investment and there is a desire to become a world leader here and provide therapeutics on a global basis. Indian R&D is also going places with more and more researchers now doing high throughput experiments and automation and hence is more mature. India definitely has the lead. YY: China does see an opportunity in drug discovery and biotechnology, but with drug discovery being a high risk proposition there is less inclination to tread the waters especially with the low return on investment. They are doing chemistry based pharmaceutical manufacturing but not much groundwork has been done. India saw a growth in domestic pharma companies in the 1980s who through all these years now know how to sustain the drug discovery business model knowing the pros and cons.   What are some of the challenges of operating in a market like India? YY: From a commercial point of view, India is an extremely brand sensitive market. It is not about what a company is introducing or the technology, but what is portrayed to the general public that matters. In the microarray segment itself, China, Korea and India are dominated by different companies. So the key is how companies are distributing the technology and who is taking the technology to different market segments. So a good services and support system is the key to establishing a presence in a country like India.   ]]> <![CDATA["The life sciences and biopharma equipment business is growing at over 30 percent,"]]> https://biospectrumindia.com/news/95/6034/the-life-sciences-and-biopharma-equipment-business-is-growing-at-over-30-percent.html https://biospectrumindia.com/news/95/6034/the-life-sciences-and-biopharma-equipment-business-is-growing-at-over-30-percent.html Wed, 06 Aug 2008 10:56:00 +0530 New Page 1 "The life sciences and biopharma equipment business is growing at over 30 percent," -S Vishwanathan, director, Labmate Asia How do you view the life sciences suppliers business in India? I was personally involved in the analytical instruments quite sometime back in the previous employment and currently I can comment more about the life sciences and biopharma equipment business. The market is still very hot and growing in India over 30 percent. The key drivers would be the speed, innovation and automation. These days, the products and technologies are launched simultaneously in India. The Indian users are quite knowledgeable and tech savvy. They can quickly evaluate the products and technologies and appreciate them. Further, with the number of international trade shows in India rising, many Indian users have the chance to have a first hand feel of the new products and technologies. The forth coming events are Bioproducts International and Drug Discovery meeting being planned in Mumbai during October 2008. Yet another Big event is the HUGO meeting in September in Hyderabad and Prof. Samir Brahmachari is a key member in this forum. What are some of the changes that you are seeing in the industry? It is no more the domestic and international market place. There is only one market "the global market". This is becoming more and more evident now in almost all sectors and technologies. We all know that many of our pharma and biopharma establishments are truly moving towards global standards in terms of products, facilities and quality. We see quite a lot of scientific and technology experts being hired from outside the country. There will be an all round influx of professionals to India, most of them will be of Indian origin, who were working in the western world, for a long time. Jahanara Parveen   ]]> <![CDATA["The market for all kinds of analytical and scientific instruments will be $1 billion,"]]> https://biospectrumindia.com/news/95/2456/the-market-for-all-kinds-of-analytical-and-scientific-instruments-will-be-1-billion.html https://biospectrumindia.com/news/95/2456/the-market-for-all-kinds-of-analytical-and-scientific-instruments-will-be-1-billion.html Wed, 06 Aug 2008 10:22:00 +0530 New Page 1 "The market for all kinds of analytical and scientific instruments will be $1 billion," -S Thyagarajan, chairman, Spinco Biotech What is the current size of the analytical instruments industry in India? What are the drivers and bottlenecks influencing the market? As the vice president of Indian Analytical Instruments Association (IAIA), president of Chromatographic Society of India (CSI) and secretary of Indian Chapter of International Society of Lyophilization and Freezedrying (ILSFD), I have the opportunity to discuss the market trend and figures with other companies. We estimate that the present market for all kinds of analytical and scientific instruments will be $1 billion. Chromatography and Mass Spectrometry (MS) products, by their sheer volume of business, will continue to be strong growth drivers in analytical instrumentation business. However, I feel that life science research products will have a higher growth rate, say not less than 25 percent per annum, driven by requirements from the newly established sectors such as Clinical Research Organizations (CROs) and R&D efforts undertaken by local and multinational pharmaceutical and biotech companies apart from increased government R&D spend. Besides the government initiatives like approving more SEZs for manufacturing will provide a favourable climate for growth in the analytical and life science instrumentation market. We strongly believe that further growth can be achieved if the government considers reduction in duties on main instruments and more so in consumables. What are the current market trends? I have just mentioned that the market size for analytical and scientific instruments in India is $1 billion. We estimate a growth rate of around 15 percent per annum and the market is expected to reach around $1.5 billion by 2010. Chromatography business is expected to grow at 15-20 percent, while MS and life science instrumentation will witness a higher growth of 20-25 percent per annum. It is reported that certain market categories such as X-Ray diffraction will achieve more than 30 percent YOY growth in the coming years. Jahanara Parveen   ]]> <![CDATA[Waiting for the rebound]]> https://biospectrumindia.com/news/95/6492/waiting-for-the-rebound.html https://biospectrumindia.com/news/95/6492/waiting-for-the-rebound.html Tue, 05 Aug 2008 17:16:00 +0530 New Page 1 Rank 20 Waiting for the rebound Alfa Laval is all geared up for the biotech boom by focusing on the separators and fermentation market. Alfa Laval India caters to the life sciences industry with a product portfolio ranging from centrifugal separators, membrane filtration systems, plate heat exchangers, pumps, valves and fluid handling equipment. Alfa Laval India was the first company to bring in the single fermenter technology in the late 1980s. The company clocked an estimated sales of Rs 20.5 crore from sales to the life sciences industry, as against Rs 30 crore in 2006-2007. Nish Patel, managing director, Alfa Laval India, said, "The company has made an investment of Rs 50 crore last year to increase its capacity and has budgeted an additional investment of Rs 40 crore for the current financial year." The expansion has mainly been on the manufacturing front. Alfa Laval has increased its capacity by 30 percent. "Back in 2005, we had a huge expansion of the plant which took care of around 100 machines and in 2007 it rose to around 700. We are in the midst of our expansion of sanitary flow so the growth number for that is 40 percent. We have also introduced new products last year, which we hope will increase our sales," added Patel. Separators have been a major product line across the world, but in India, fermentors and stem culture separators have been a major growth area for it. To cater to this market, Alfa Laval is at present going through the GMP standards. Its clients include Wockhardt, Nicholas Piramal, Biocon, Sterling Biotech, and Reliance Life Sciences. Another area of growth for the company was primary contractors. With 18 branches across India, Alfa Laval now has a strategy to focus on introducing more GMP manufacturing units. Earlier, Alfa Laval was awarded the GMU status by its Swedish unit to manufacture centrifugal separators and decanter centrifuges for exports to Alfa Laval, Sweden. It also received the ISO 900:2000 certification from Lloyds Register Quality Assurance, UK for its manufacturing services. Surprisingly, this year the company is not looking at any such partnerships and alliances. Also last year, the company launched heat exchangers. This product line is pitched to be a major growth area for the company in the current fiscal. While Alfa Laval is understood to have a huge market share of 70-75 percent in heat exchangers, its sanitary business' share is close to 40 percent. "Our counterparts in the global business claim that apart from Europe and the US, India is one the major markets and growth can emanate only from here because Indian companies have already started to gear up for the biotech boom," added Patel. ]]> <![CDATA[Making new forays]]> https://biospectrumindia.com/news/95/2692/making-new-forays.html https://biospectrumindia.com/news/95/2692/making-new-forays.html Tue, 05 Aug 2008 17:10:00 +0530 New Page 1 Rank 19 Making new forays With a direct presence in India for two years, Beckman Coulter has made a mark in the Indian life sciences and R&D market segments. Beckman Coulter India Pvt Ltd was established as a wholly owned direct subsidiary of Beckman Coulter Inc. USA in November 2005. Beckman Coulter is a leading manufacturer of biomedical testing instrument systems, tests and supplies that simplify and automate laboratory processes. Spanning the biomedical testing continuum-from pioneering medical research and clinical trials to laboratory diagnostics and point-of-care testing-Beckman Coulter's 2 lakh installed systems provide essential biomedical information to enhance health care around the world. The company, based in Fullerton, California, US, reported 2007 annual global sales of $2.76 billion with more than 78 percent of this amount generated by recurring revenue from supplies, test kits and services. Beckman Coulter India's life sciences research portfolio clocked revenues of Rs 24 crore, with major contributions coming from centrifugation, flow cytometry, automation, proteomics and particle characterization streams. "For life sciences, we have a systems biology approach--Provide standardized solutions for systems biology to enhance biomarker discovery and commercialize diagnostic markers," said a company source. Prior to establishing a direct subsidiary in India, for 16 years, the company was represented in India through a reputed distribution channel. For Beckman Coulter India, the diagnostic and life science research portfolios have been major growth contributors in this subsidiary's total revenue sales. For the life sciences sector, the company has a product portfolio ranging from centrifugation, research flow cytometry, automation, proteomics, genomics, and analytical instruments. Beckman Coulter India has an employee strength of over 60 in India. The company mainly caters to the diagnostics (hematology, immunochemistry and biochemistry), bio-pharmaceuticals (R&D, quality control), discovery research and government-funded research institutes, pharmaceuticals and allied industries in India. The Centrifugation portfolio comprises of the entire range of equipment from a table top micro centrifuge to the most technologically advanced ultra centrifuge. The flow cytometry portfolio comprises of entire range that can cater to the research segment as well as the clinical diagnostic segment right from a basic analyzer to a very high end cell-sorting system. The automation portfolio comprises of Biomek series systems for automating laboratory processes with standard as well as customized configurations. Beckman Coulter introduced several new products like Unicell DxI 600 Immunoassay system and the Optima Max XP Table Top Ultra Centrifuge in the Indian Market in 2007. Dr Chandrasekhar SP, MD, Beckman Coulter India Pvt Ltd, said, "At present our major area of investment has been to consolidate ourselves in the market and that is in infrastructure. At present, we are in the first phase of investments and in the next few years we will see how the market goes and the accordingly channelize our investments." ]]> <![CDATA[Flowing smoothly]]> https://biospectrumindia.com/news/95/1744/flowing-smoothly.html https://biospectrumindia.com/news/95/1744/flowing-smoothly.html Tue, 05 Aug 2008 16:48:00 +0530 New Page 1 Rank 15 Flowing smoothly With a growth rate higher than the industry, Eppendorf India's market penetration in 2007-08 has been very smooth. Eppendorf India is the Indian arm of Eppendorf AG, Germany, founded in Hamburg in 1945 and has more than 2,000 employees worldwide. The company has subsidiaries in 20 countries and is represented in all other markets by distributors. Head quartered in Chennai, with eight branches all over the country, Eppendorf India is in a unique position to serve the customer in India. With more direct access to the Indian market, Eppendorf successfully presents and markets latest technologies for biotech research. The local organization is staffed with a team of product managers, sales, service and application specialists to ensure that professional support and assistance is offered to all end users. In fiscal 2000-07, the company's sales revenues amounted to Rs 41.9 crore as against Rs 29 crore in 2006-07 thus registering an impressive growth of 44 percent. Eppendorf develops, produces and distributes systems for use in life-science research laboratories worldwide. Its product range includes pipettes, dispensers and centrifuges as well as consumables such as micro test tubes and pipette tips. In addition, Eppendorf provides instruments and systems for cell manipulation, automated devices for liquid handling, complete equipment for DNA amplification and biochips. A series of complementary products manufactured by the company and other companies round off this product range. Eppendorf products are aimed at academic and commercial research institutes as well as industrial companies in the field of biotechnology or in other sectors using biotech research processes. In November last year Eppendorf launched Science Trek, a state-of-the-art, world class laboratory on wheels dedicated to biotech, pharmacology, chemistry and other science students in India. Science Trek will visit educational and research institutions free of cost all over the country to take them on an exciting voyage to the frontiers of lab technology. The mission of Science Trek is to showcase and demonstrate the latest lab equipment so that students can see for themselves the equipment and technologies of tomorrow. Additionally, the mobile lab is bridging the gap between the privileged, urban centers of learning in metros and the relatively unequipped labs in semi-urban and rural colleges. ]]> <![CDATA[A move towards imaging and genomics]]> https://biospectrumindia.com/news/95/1784/a-move-towards-imaging-and-genomics.html https://biospectrumindia.com/news/95/1784/a-move-towards-imaging-and-genomics.html Tue, 05 Aug 2008 16:45:00 +0530 New Page 1 Rank 14 A move towards imaging and genomics DSS Imagetech has emerged as a comprehensive technology provider, increasing its focus on molecular diagnostics and closed several big deals during the year. New Delhi-based DSS Imagetech provides cutting edge technology solutions to researchers and clinicians working in areas like genetics, drug discovery, and biotechnology. Its range of products and application areas include microscopy, image analysis software systems, genetic workstation, ICSI workstations, DNA probes, and micro array readers. The company recorded Rs 68.04 crore in revenues in FY2007-08, registering 26 percent growth over the previous year's revenues of Rs 54 crore. The life sciences division of the company grew by nearly 37 percent during the year as opposed to 50 percent in 2006-07. Consumables and reagents were the biggest growth drivers for the company this year. The three companies that it represents in this area registered a formidable growth. While Dako (pathology) grew by 40 percent, Takara Clonetech (molecular biology reagents registered double digit growth, while Abott Molecular grew by 28-30 percent. Viral load testing for HIV and HER2NO for detecting breast cancer were the two major revenue grossing technologies from Abott. A polymer based detection kit for antibodies from Dako, called Nvision, also helped boost its sales. The company bagged a major order from AIIMS for high-end flowcytometer. It also won an order from GB Pant Hospital. Microarray business was slow paced except for an order that the company got from ICRISAT. The company has installed around 28-32 microarrays in the last few years. It also received an order for DNA synthesizer from Ocimum Biosolutions and a proteomics order from the Indian Institute of Chemical Biology, Kolkata. DSS, which opened its training center last year, trained 35 people in IHC and FISH. During the year, DSS has opened new branches in Chandigarh, Thiruvananthapuram, Ahmedadbad and Lucknow to boost its sales. The company is focusing on strengthening its presence in Gujarat and UP too. During the year, DSS has tied up with Carestream Health that acquired Kodak imaging products. It is also strengthening its relationship with Beckman Coulter. The company aims to position itself as a total solution provider and has now focused its attention on the imaging and genomics solutions with which it has natural synergy. ]]> <![CDATA[Consolidation continues]]> https://biospectrumindia.com/news/95/1341/consolidation-continues.html https://biospectrumindia.com/news/95/1341/consolidation-continues.html Tue, 05 Aug 2008 16:40:00 +0530 New Page 1 Rank 13 Consolidation continues Renewing its partnership with Stratagene (microbiology) and HyClone (cell culture and bioproduction), Genetix Biotech consolidated its business, registering a 37 percent growth in its revenues. Genetix Biotech Asia, based in New Delhi, provides laboratory research products such as filtration membranes and devices, molecular biology kits and reagents, biochemistry, protein assays, fine chemicals, immunology reagents, cell and tissue culture, serum and media, chromatography accessories and various instruments from leading multinational brands. These products find their application in the area of molecular biology, cell culture, genomics, proteomics and immunology. It represents several leading global companies like Qiagen GmbH, Fermentas Life Sciences, Ambion Inc., Operon Biotechnologies GmbH, Amaxa GmbH, Whatman Biometra GmbH, Nalge Nunc International, Nunc A/s, Tosoh Bioscience GmbH, and Santacruz Biotechnolgies and has in total of 21 strategic distribution relationships. Nine of its relationships are in molecular and cell biology and this business accounts for a large chunk of its revenues. The company's revenues in FY 2007-08 increased to Rs 70 crore from the previous year's figure of Rs 52 crore. It grew nearly by 37 percent in 2007-08. The company has been growing around this mark for the last several years. Two of its principals, Stratagene (microbiology) and HyClone (cell culture and bioproduction) returned to its fold last September. The Hyclone business alone accounted for close to 17 percent share of its total revenues in 2007-08 and a higher growth is forecast in the coming years. Being a research-driven company, nearly 55 percent of its revenue comes from the biopharmaceutical industry (both R&D and production) with companies such as Reliance Life Sciences, Serum Institute of India, Indian Immunologicals and Shantha Biotech being some of its key clients. The rest of its revenues come from the research and diagnostics sectors. Last year saw the company launch a whole range of bioseparation products including filtration, chromatography, and ultrafiltration under the Genetix brand. The company is also working on a project under SIBRI worth Rs 80 lakh sanctioned by DBT in the area of developing molecular diagnostics for two bovine diseases. It also has a full-fledged molecular biology and cell culture laboratory for in-house training, customer demonstration and training, and quality control back up. ]]> <![CDATA[Architects transformational medical technologies]]> https://biospectrumindia.com/news/95/6259/architects-transformational-medical-technologies.html https://biospectrumindia.com/news/95/6259/architects-transformational-medical-technologies.html Tue, 05 Aug 2008 16:33:00 +0530 New Page 1 Rank 12 Architects transformational medical technologies Introducing new products like the ReadyToProcess portfolio and Biacore, GE Healthcare Life Sciences is consolidating its position in Indian life sciences sector. Headquartered in the UK, GE Healthcare is a $17-billion unit of General Electric Company. GE Healthcare works in six different primary areas--diagnostic imaging, global services, clinical systems, medical diagnostics, integrated IT solutions and life sciences. The company is sharpening its focus on its life sciences business in India, driven largely by the growth in the domestic biotechnology sector. It is ramping up its overall India operations to cater to the customers' needs faster and more efficiently. In 2007-08, the company's total sales revenue from the life sciences products in India grew to Rs 80 crore as against Rs 61.50 crore last year. The growth drivers were mainly the separation techniques, lifesciences instrumentation and filtration products. As a leading supplier of systems and solutions in the biotech and biopharma space, GE Healthcare Life Sciences positions itself as a key "enabler" in getting drugs to market faster, better and more efficiently. GE Healthcare Life Sciences has been a key supplier of bioprocess, protein purification, chromatography, columns, media and filtration products to the major players in India in the biotech space and GE's products and services are generally regarded by customers as the best-in-class. GE Healthcare Life Sciences has a strong commercial team in India with offices at Bangalore, Delhi, Chennai, Mumbai, Hyderabad, Kolkata, Pune and Chandigarh, besides a competent service team to serve its customers. Its BioInSite facility, available with some select systems, enables remote monitoring and diagnostics through a secure digital connection, thereby providing higher uptime and greater equipment productivity. The company intends to continue to invest in its manpower, skills, and competencies to address the growing needs of the India customers. Its R&D and training facilities and FastTrack Global Services at the GE John F Welch Global Research Centre at Bangalore further complements its commercial operations, and this is the key to providing a One-Stop-Shop solution to varied needs of all their Indian customers. GE Healthcare has introduced a new portfolio of ready-to-use systems and devices designed for biopharmaceutical production. The ReadyToProcess portfolio is a range of products designed to meet the biopharmaceutical industry's need for increased speed, simplicity and safety in all areas of bioprocessing--from cell culture and fermentation to final purification. In addition, GE Healthcare Life Sciences offers a very unique product called Biacore, which has niche applications in the areas of protein-protein interaction, binding affinity and kinetics. According to the company's officials, Biacore equipment is available in several models, and a large number of leading research institutions in India has been procuring this equipment from GE and this equipment is finding increased applications with BioPharma and Biotech customers as well. ]]> <![CDATA[Performance unrivaled]]> https://biospectrumindia.com/news/95/1560/performance-unrivaled.html https://biospectrumindia.com/news/95/1560/performance-unrivaled.html Tue, 05 Aug 2008 16:32:00 +0530 New Page 1 Rank 11 Performance unrivaled Imperial Life-Sciences, with a diverse portfolio of products and solutions, has outperformed rivals on growth. Established in 1992, Imperial Life-Sciences Pvt Ltd (ILS), is in the business of instrumentation, reagents, software and other consumables, providing complete solutions for laboratories working in genomics, proteomics, drug discovery and bio-production process. It is the exclusive representative for several leading global players in India like Agilent Technologies, Invitrogen Corporation (Gibco, Molecular Probes, Dynal, Caltag, Biosource, Zymed), Caliper Life Sciences, Xenogen, Biotage, IDT, CBS Scientific, Amresco, Fitzgerald and various others companies. The company registered nearly 126 percent growth in its revenue, clocking Rs 88.73 crore in FY2007-08 as against Rs 39.25 crore in 2006-07. It was the fastest growing Top 20 BioSupplier in 2007-08. The company was able to place 50-60 bioanalyzer systems from Agilent in major research institutes and has aggressive plans to place these systems in the Indian market in the coming months. The company sold four systems from Xenogen to major research institutes like IICB, Kolkata and Indian Institute of Science Bangalore. The company has sold six in vivo imaging systems from Caliper last year and plans to sell 10-12 in the coming financial year. The company grew strongly in QPCR and custom oligos and also in the Nucleic acid Purification and isolation business. Molecular biology segment from Invitrogen and custom media and services also contributed significantly to the growth. Liquid handling systems from Caliper were a new product segment and it sold five of them in 2007-08. The company, according Neeraj Gupta, managing director, ILS also became the top supplier of foetal bovine serum in India. The company sold 12 microarray systems in the last financial year and was able to successfully introduce the concept of Genome wide work stations. ILS also set up ILS-USA cooperation to provide product support in January last year. It doubled its sales force and technical support manpower during the year. The company is looking forward to setting up bigger facilities in Calcutta and Pune. It will be consolidating its product portfolio too, as some its key principals like Invitrogen have announced major acquisitions in 2007-08. The company is also looking at setting up a Bioservices division to train people in high end technical instruments for the industry. ]]> <![CDATA[Aiding science turn into business]]> https://biospectrumindia.com/news/95/1477/aiding-science-turn-into-business.html https://biospectrumindia.com/news/95/1477/aiding-science-turn-into-business.html Tue, 05 Aug 2008 16:29:00 +0530 New Page 1 Rank 10 Aiding science turn into business Offering a wide range of laboratory and process products, Sartorius India has grown its life sciences business to Rs 95.60 crore in 2007-08. Sartorius India Pvt Ltd, which delivers a comprehensive set of tools and services right from the concept stage of a project through design, engineering, manufacture, commissioning and validation support to training of personnel and after sales service, has clocked Rs 95.60 crore in sales from life science industry solutions in 2007-08. The company's this business registered a growth of over 23 percent. The success of Sartorius India mainly comes on account of its ability to efficiently translate and imbibe customers' needs and evolve solutions. "Fostering strong and reliable partnerships with bio-suppliers with a global base and reach allows the scientists access to developments and changing technologies rather than re-inventing the wheel themselves all the time. By offering its process expertise in chosen technology areas, Sartorius collaborates with biotech companies in their product and process development at a very early stage to help them to improve the yields and reduce process complexity. Rooted in the philosophy of turning science into solution, Sartorius has also been actively helping the biotech R&D in optimizing processes using both the existing and new technologies and offering customized training programs to its customers," said Amit Chatterjee, managing director, Sartorius India. On another front, Sartorius has been developing its product portfolio to offer comprehensive process support through internal developments and strategic alliances, such as building up a complete disposable concept including disposable sensors for biopharmaceutical processes to reduce CAPEX, validation costs and time to market. Sartorius India plays a key role within Sartorius Group as one among four system manufacturing facilities for Sartorius worldwide (the other three are located in the US, Germany and Italy). Sartorius offers an extensive portfolio of products, technologies and services for fermentation and cell culture in upstream processing of biopharmaceuticals; membrane chromatography designed for removal of contaminants, such as DNA, host cell proteins, endotoxins and viruses; disposables, filter cartridges, housings and filter holders for particle-removing and sterilizing grade filtration of liquids and gases; micro- and ultrafilter crossflow systems to the pharma and biotech companies. Almost 40 percent of its revenues came from filtration systems, while the general laboratory instruments accounted for 28 percent of the total business. ]]> <![CDATA[Success by providing access]]> https://biospectrumindia.com/news/95/2549/success-by-providing-access.html https://biospectrumindia.com/news/95/2549/success-by-providing-access.html Tue, 05 Aug 2008 16:23:00 +0530 New Page 1 Rank 9 Success by providing access Focusing on personalized support and customized solutions, Shimadzu Analytical India grew its life sciences business to Rs 128 crore in 2007-08. Shimadzu Analytical (India) Pvt Ltd (SAIP) is a subsidiary of Shimadzu Corporation, Japan, a pioneer of several leading technologies in the areas of analytical, scientific and process control instrumentation, environmental monitoring systems, and industrial machinery. Shimadzu Analytical (India) was set up in 2006 to step up its commitment to India. Nonetheless, Shimadzu Analytical is not a new entrant to the Indian life sciences industry. It has more than four decades of presence in India through four partners--Spinco Biotech, Toshvin Analytical Pvt Ltd, Swan Environmental Pvt Ltd and Amkette Analytics Ltd. And its direct entry to India was a step towards extending that long-lasting relationship with enhanced personalized support, diverse product portfolio, and customized solutions. SAIP's business in India continues to grow on that fundamental strategy of stronger relationships and personalized support. In 2007-08, its total revenues in India stood at Rs 185 crore, with its life sciences division alone contributing Rs 128 crore and registering over 16.4 percent growth compared to the previous fiscal's life sciences business of Rs 110 crore. This growth has come despite the currency fluctuation in India. "India offers tremendous opportunities for SAIP. We have plans to take full advantage of this dynamic market situation. We have distributors in India who are with us for more than 40 years. SAIP's approach is to support customers with innovative solutions to their growing needs," said Senya Imamichi, managing director, Shimadzu Analytical India. As part of its strategy of being closer to the customer, SAIP set up a customer support center in Mumbai in 2006-07 to provide training on different instruments to the customers, besides helping the customer on method development. In 2007-08, it opened a new customer support center in New Delhi to strengthen its technical and application support to the customers and upgraded its Mumbai center. In its efforts to provide personalized solutions, SAIP signed an agreement with Waters and launched Empower connectivity, which facilitates the Empower software to seamlessly connect and control with Shimadzu HPLC. "This has been a request from many customers in India and by this connectivity, we are confident of gaining more space in Laboratory," added Imamichi. SAIP is a leading vendor of HPLC systems and targets the pharmaceutical market, which has highest market requirement. Its fully-automated HPLC system, LC-2010HT, has been well received by almost all major life science companies in India and has over 2,000 installations. Prominence, launched about two years back, has specs and performance that are a benchmark in the industry. Prominence has over 1,000 installations in the country. The company recently launched five new products in India, namely UV-1800 (Spectrophotometer), IRAffinity-1 (FTIR), MultiNA (Micro Capillary Electrophoresis System), UFLC-XR (Ultra Fast LC system) and the Nano HPLC. And SAIP will concentrate on the promotion of these products this year through seminars and by participating in major trade shows. ]]> <![CDATA[Advancing life sciences research]]> https://biospectrumindia.com/news/95/2331/advancing-life-sciences-research.html https://biospectrumindia.com/news/95/2331/advancing-life-sciences-research.html Tue, 05 Aug 2008 16:08:00 +0530 New Page 1 Rank 8 Advancing life sciences research With a broad range of life science tools, technologies, and services today in its portfolio, Millipore India has made significant impact in the country. Millipore India is one of the leading providers of cutting-edge technologies, tools, and services for bioscience research and biopharmaceutical manufacturing. From research to development to production, the company's scientific expertise and solutions are aimed at helping the customers tackle complex problems and achieve their goals. Millipore India is a JV with Millipore Corporation, an S&P 500 company with more than 30,000 products and 6,100 employees in 47 countries worldwide. Millipore India's revenue for the year 2007-08 stood at Rs 173.19 crore as compared to Rs 136.07 crore in FY 2006-07, registering close to 27 percent growth. Millipore India today provides the manufacturers of biopharmaceuticals in India its entire range of solutions from upstream to downstream processing of biologics, including cell and media supplements, advanced manufacturing solutions, process monitoring tools, filtration purification and chromatography solutions plus validation and process development services and training from the bioprocess division. The bioscience division, in addition to the highly successful range of water purification systems and solutions for general filtration, protein research, genomics and drug discovery, extended it range to include gold standard reagents, media, cell lines and antibodies from Chemicon, Upstate and Linco. With this, Millipore offers solutions in research areas such as cardiovascular and infectious diseases, oncology, matrix biology, cytokines, neuroscience, metabolic disorders and signal transduction. The lab water purification range continues to make more breakthroughs, both in market dominance and in new innovations, according to Sudhir Kant, president, Millipore. The Milli-Q Integral with Q-Pod and E-Pod is a new breakthrough in water delivery systems. To support its customers better, Millipore India has launched a centralized customer support package, Safari. Millipore's bioprocess validation and process development facility has established its Extractable Lab while completing the maximum number of filter validation studies in India. ''Quality solutions, cost containment, and speed to market are the key attributes in the industry today. And Biosuppliers like Millipore have led the way in making all this possible in the research, development and manufacture of biologic based medicines through world-class infrastructure, the introduction of the latest technologies, and an approach that focuses on solution selling rather than pushing products. Advanced solutions in protein engineering--monoclonal antibodies, recombinants including the award winning UCOE ( Ubiquitous Chromatin Opening Element) platform that revolutionalizes the speed by which protein therapeutics can be produced in mammalian cells, faster than any existing means, are but a few examples of innovations by biosuppliers like Millipore,'' added Sudhir Kant. ]]> <![CDATA[Enhancing therapies]]> https://biospectrumindia.com/news/95/2894/enhancing-therapies.html https://biospectrumindia.com/news/95/2894/enhancing-therapies.html Tue, 05 Aug 2008 15:47:00 +0530 New Page 1 Rank 7 Enhancing therapies BD is not only working to improve access to tuberculosis (TB) and HIV/AIDS monitoring in India, but has also come up with breakthrough technology for stem cell research. Becton Dickinson (BD) operates in India through a wholly-owned subsidiary, BD India Pvt Ltd. BD is focused on improving drug therapy, enhancing the quality and speed of diagnosing infectious diseases, and advancing research and discovery of new drugs and vaccines. BD operations consist of three key segments--BD Medical, BD Diagnostics and BD Biosciences. BD's biosciences segment is focused on providing integrated systems, products and services for a variety of applications in life sciences. Some of its major products include flow cytometry systems for cell analysis, monoclonal antibodies for biomedical research, molecular biology reagents for the study of genes, cell growth and screening products and labware products. BD India recorded Rs 178.63 crore in revenues from the life sciences business in FY 2007-08, recording a growth of approximately 34 percent over the previous year's revenues of Rs 133 crore. Almost 50 percent of its total revenues come for the cell analysis products. The company's range of instrumentation products--FACSCanto II and FACSAria II--launched last year has contributed significantly to its sales. While FACSCanto II deals in multicolor analysis flowcytometry technology where scientists can get more information per cell per experiment, FACSAria II System with solid state UV laser aids studies on stem cell therapy and sorting. Its Gentest product range, which enables biotech companies to do ADMETox studies on new and old molecules, with new process aiding in their drug discovery process, has also been well received in the market. The product is targeted at the CROs and pharma R&D and is growing by 100 percent every year. Recently BD acquired US-based Cytopia, which deals in a product called Influx that finds its application in experimental stem cell therapy, a new concept in the field of stem cell research. BD plans to launch the product soon. It has been a good year for BD's standing on the corporate social responsibility front too. It was recently recognized by the Global Business Coalition on HIV/AIDS, Tuberculosis and Malaria (GBC) for its efforts to improve access to tuberculosis (TB) diagnostic equipment in developing countries. The GBC is a coalition of more than 220 companies united to keep the fight against HIV/AIDS, TB and malaria a global priority. The company is also setting up a center of excellence for flowcytometry in collaboration with National Center for Biological Sciences, Bangalore, that will help provide training and support to scientists. It is also plans to launch a product called CD4 percentage later this year for AIDS monitoring. The company has been at the forefront of conducting GLP programs in the country, covering 73 sites and has also won the TERI corporate award for the same recently. ]]> <![CDATA[Offering right choices]]> https://biospectrumindia.com/news/95/6628/offering-right-choices.html https://biospectrumindia.com/news/95/6628/offering-right-choices.html Tue, 05 Aug 2008 15:36:00 +0530 New Page 1 Rank 6 Offering right choices With an estimated turnover of Rs 180 crore, HiMedia Laboratories is a leading player in culture media and peptones market in India. HiMedia Laboratories, established in 1976 as Hindustan Dehydrated Media and as a company to provide ready-to-use culture media to scientists, researchers and small companies, who used to prepare their own media from purchased ingredients, has come a long way. HiMedia, today, has developed its own technology for manufacture of culture media and is an ISO 9000 company. HiMedia clocked a total turnover of Rs 180 crore in fiscal 2007-08, registering 20 percent growth from the previous year's total sales of Rs 150 crore. The company's sales turnover in 2005-06 was Rs 120 crore. Today, HiMedia exports its products to over 100 countries and has a strong foothold in the BRIC countries like Russia and Brazil. It is also actively tapping the US market. "If we do well here then the rest of the world will be easier," commented Dr Vishal Warke, director, R&D, cell culture, HiMedia Laboratories. In order to fulfill the demand for culture media products, the company is beefing up its production facilities. It is coming up with facility at Ambarnath to produce protein hydrolysis products. Dr Vishal Warke said, "The facility will help in bridging the supply shortage gap. We have been dealing with many reputed companies in India and realized that we have been falling short of protein hydrolysis in India. Globally too there is a demand for such products." The company is also looking at a US FDA certification and GMP compliance. This facility, which will be an entirely vegetable facility, will provide ultra-filtered hydrolysis and ultra-filtered vegetable peptones. "Our facility provides around 20 vegetable-based peptones and we are making around 1,000 culture media. The estimated investment for this facility alone is around Rs 35-50 crore," added Dr Warke. HiMedia is also looking at setting up manufacturing operations in the US. VWR, a US-based distribution company, has tied up with HiMedia for vegetable-based media and vegetable-based peptone and these would be included in their catalogues. "VWR is selling HiMedia products as a joint label and this partnership is really important to us as it can change the face of HiMedia and contribute significantly to our growth in the next few years." HiMedia earlier had a tie-up with Sigma. But its products were marketed under the Sigma label. HiMedia is also coming out with kits for detection of MRSA and also VRSA in collaboration with the scientists from Yale University, which has given exclusive rights to HiMedia to manufacture these kits for global use and at an affordable cost. HiMedia will soon be offering Serum free media too. Another area where the company has plans to enter is the stem cell culture and primary cell culture. ]]> <![CDATA[Exceeds expectations]]> https://biospectrumindia.com/news/95/2632/exceeds-expectations.html https://biospectrumindia.com/news/95/2632/exceeds-expectations.html Tue, 05 Aug 2008 15:30:00 +0530 New Page 1 Rank 5 Exceeds expectations With over 27 years of successful service and proven track record, Spinco Biotech's life sciences business in 2007-08 crossed the Rs 200 crore mark. Chennai-based Spinco Biotech is another successful home-grown Indian company that has consolidated its position as a top life sciences supplier in the country with total life sciences revenues of Rs 210.27 crore. Its revenues increased by almost 35 percent compared to the previous year's figure of Rs 156.17 crore. A substantial portion this revenue came from its chromatography business unit. The company's life science and lab products divisions grew much higher than industry average, thus contributing to its overall growth. Spinco expects the growth to be lower this fiscal owing to the difficult macro economic conditions, high inflationary trends, and uncertainties in exchange rates. Commenting on the company's impressive growth, S Thyagarajan, chairman, Spinco Biotech said, "We had a good growth of over 30 percent during fiscal 2007-08. This has been a good performance considering the highly competitive market we operate in and the fluctuating economic situations. We concentrated on introducing the latest technologies and best-in-class instrumentation products and working closely with the customers to develop new applications and addressing their evolving needs with support from principals." Even though the number of global leaders setting up their subsidiaries in India is on the rise, Spinco has managed to be on the top for several years now because of its successful and proven track record of delivering solutions and quality services. Its approach has been to complement the strategies of the principals. Spinco's partnership with Shimadzu for over 25 years reiterates the point. Some of the major developments at Spinco included inauguration of two new office premises--a new office and warehouse at Chennai for its chemistry and consumable products business unit and an office and demo lab in Ahmedabad. It also bagged a major order for Affymetrix gene chip technology for the Avesthagenome project. Spinco's Lyo and Lab Products (LLP) commissioned its largest lyophilizer capacity project in India with fully automated loading and unloading facility. On the partnerships front, Spinco renewed its agreement with Molecular Devices, now part of MDS Technologies, besides signing up with Fuji Lifesciences, Japan, for imaging solutions which would complete Spinco's proteomics offering. It also signed a strategic agreement with Kinematica, Switzerland, a global leader for 50 years in dispersion and mixing technology. Spinco now plans to establish a world-class life sciences application and training lab with advanced instrumentation facilities for genomics. "This lab will be run by experienced scientists who will closely work with the customers. It will also be a training centre for customers and field staff in emerging areas of genomics," added Thyagarajan. Outlining the future strategies, Thyagarajan recounted, "Spinco will continue to seek more strategic partnerships with companies which have newer technologies and would like to leverage our network and skill sets to promote their products in India." ]]> <![CDATA[Making high impact through innovation]]> https://biospectrumindia.com/news/95/2604/making-high-impact-through-innovation.html https://biospectrumindia.com/news/95/2604/making-high-impact-through-innovation.html Tue, 05 Aug 2008 15:03:00 +0530 New Page 1 Rank 4 Making high impact through innovation Waters India has scripted a success story by creating business advantages for laboratory-dependent organizations through its solutions. Waters India, the wholly-owned subsidiary of Waters Corporation and a leader in chromatography systems, has maintained its high double digit growth and increased its revenues from the life sciences business to Rs 264 crore in 2007-08 as against Rs 213.20 crore in 2006-07, registering a growth of over 23 percent. Waters has been a pioneer in bringing advanced technologies in the separation science, laboratory information management, and mass spectrometry to India and backs it up with efficient and prompt service and applications support. In 2007, India accounted for 5 percent share of the total global business of Waters. "We want to grow every year and contribute significantly to Waters Corporation," said KV Venugopalan, president, Waters India. The strategy of the company is to stay focused in the areas in which its customer base has the highest degree of challenge. The passing year has been a very exciting one for Waters in that direction. In the mass spectrometry range, it introduced a new Tandem Quadrupole device (TQD) and a new hybrid quadrupole-time of flight technology system, the Synapt HDMS. The Synapt HDMS system, a high definition mass spectrophotometer, integrates ion mobility technology within a Q-Tof geometry instrument configuration and allows researchers to glean molecular shape information. Waters had introduced Acquity UPLC a couple of years back and this product with more than 6,200 installations worldwide has become one of its fast growing products. And Waters during 2007-08 introduced several variations of Acquity and one of them being PATROL UPLC Process Analyzer, a real-time Process Analytical Technology (PAT) System that can detect and quantify complex multiple component manufacturing samples and final product on the production floor. "UPLC's increased peak concentrations with reduced chromatographic dispersion result in increased source efficiencies and vast improvements in MS sensitivity and spectral quality. With sharper peaks and improved chromatographic resolution, UPLC enhances the performance and productivity of any LC/MS or LC/MS/MS experiment," explained Venugopalan. Apart from introducing products, Waters signed a joint cooperative agreement with the Indian CRO Lambda Therapeutic Research to provide analytical laboratory equipment designed to enhance research quality service and business solutions for Lambda and its clients. In another major development, Jubilant Organosys recently selected Waters India as outstanding sourcing partner for the year 2008 from among 300 vendors in the category of machinery and equipment. "All Waters' products are successful and all the products are very well accepted in the market. Alliance and the basic HPLC systems continue to be the largest selling products in the country. We sell more than 700 Alliance systems every year," shared Venugopalan. ]]> <![CDATA[Realizing opportunities]]> https://biospectrumindia.com/news/95/2690/realizing-opportunities.html https://biospectrumindia.com/news/95/2690/realizing-opportunities.html Tue, 05 Aug 2008 14:47:00 +0530 New Page 1 Rank 3 Realizing opportunities Labindia has continued to maintain its strong hold in the real time PCR and PCR segment to record Rs 274.5 crore in revenues in 2007-08. Labindia, which is engaged in the marketing and manufacturing of various analytical instruments, accessories and other products that are used by the chemical, pharmaceutical, petrochemicals and biotechnology industries as well as for basic research in academic and government laboratories, is the leading Indian life sciences supplier company with revenues of Rs 274.5 crore in 2007-08. The company registered 26.7 percent growth in its life sciences business riding the wave of growing demand for PCR and Real Time PCRs besides its strategic initiative for reagents sales. The biggest product launch for Labindia last year was SOLiD from Applied Biosystems. This is a next generation sequencing technology that can sequence complete genomes in a matter of weeks rather than years as in past. "With the funding from the government being less, as it is the last year of the Tenth Five Year Plan, the DNA sequencers business grew in lower double digit, while Mass Spectrometry (MS) business grew in single digit. However, the Real Time PCR and PCR business grew by 31 percent over last year," said VS Upadhye, managing director, Labindia Life Sciences. Labindia's Technical Center in Gurgaon is a well-equipped laboratory with the latest Applied Biosystems genomic and proteomic instruments, UV spectrophotometers, centrifuges, hybridization ovens and cold-storage equipment. The laboratory recently received accreditation from The National Accreditation Board for Testing and Calibration Laboratories (NABL) for carrying out tests in various areas of molecular biology. The company also introduced the Basmati Verifier Kit, claimed to be the world's first product for establishing the authenticity of Basmati rice samples. The kit is manufactured and marketed by Labindia and was developed by a group of scientists from the Centre for DNA Fingerprinting and Diagnostics (CDFD) in Hyderabad for use in conjunction with Applied Biosystems' Genetic Analyzer platforms. In February this year, Labindia and Applied Biosystems have donated DNA sequencing equipment (The 3730xl Genetic Analyzer) to the Genome Foundation to help the organization achieve its goal of reducing suffering from genetic diseases. In the future, the company wants to enter into applied research for the new products in the food testing and analysis area and is also working in the area of molecular diagnostics and forensic science while exploring partnerships in medical and biomedical fields. ]]> <![CDATA[Delivering high performance]]> https://biospectrumindia.com/news/95/2035/delivering-high-performance.html https://biospectrumindia.com/news/95/2035/delivering-high-performance.html Tue, 05 Aug 2008 13:16:00 +0530 New Page 1 Rank 2 Delivering high performance Agilent Technologies has consolidated its chromatography and mass spectrometry business to register a record business of Rs 277.77 crore. The life sciences sector has been one of the key growth areas for Agilent India. The growing awareness and requirements from the regulatory stand point, both in the pharma and non-pharma segments, have been the strong driving forces behind the company's rapid growth. The company's strong global presence and reliability as a solution provider have made an increasing number of Indian customers look upon Agilent as their reliable partners in the growth path. Agilent India's life sciences business, in 2007-08, stood at Rs 277.77 crore, registering 43 percent growth over that in the previous fiscal. "The pharma sector has been a large contributor to the total revenues of Agilent's Life Sciences and Chemical Analysis (LSCA) business, a major share of which came from the regulated pharma," said Sanjeev Dhar, country manager, LSCA group, Agilent Technologies. Agilent's core strength has been its chromatography business. Its industry-benchmarked 1200 series HPLC and 7890 GC have been its biggest revenue generators. According to Dhar, Agilent's Rapid Resolution LC (RRLC), a fast LC, has been a big success in the pharma segment. Agilent also launched 1120 Compact LC, a product for the mid range market segment and the product according to Dhar has received a positive feedback and the orders for the same are on the rise. During the year, Agilent's mass spectrometry (LCMS and GCMS) products also saw a big jump in revenues. Today Agilent is one of the few players, which has a total portfolio of mass spectrometry techniques that span the various application needs of the industry. With the instrumentation needs growing, its portfolio of lab informatics solutions, like the enterprise content management, OpenLAB and Electronic Lab Notebook, has also showed high double digit growths. The company announced its biggest sale to date of analytical instrumentation in India. The order was placed by Orchid Chemicals & Pharmaceuticals Ltd in December and it includes more than 50 instruments, mainly RRLC systems and gas chromatography systems and headspace samplers. In February this year, Agilent introduced the Rice Oligo DNA microarray 44K RAP-DB, a new microarray, which is based on the genome information compiled by the National Institute of Agrobiological Sciences (NIAS), Japan in its open database. The last fiscal has been rebound year for Agilent and it is clearly on its way to consolidate its position in the Indian market place. ]]> <![CDATA[Ahead with inorganic growth]]> https://biospectrumindia.com/news/95/2252/ahead-with-inorganic-growth.html https://biospectrumindia.com/news/95/2252/ahead-with-inorganic-growth.html Tue, 05 Aug 2008 13:08:00 +0530 New Page 1 Rank 1 Ahead with inorganic growth With estimated sales of Rs 395 crore, India is today a major hub for Thermo Fisher Scientific's global growth strategies. Thermo Fisher Scientific (TFS), earlier known in India as Thermo Electron LLS India, is a wholly owned subsidiary of the Massachusetts-based Thermo Fisher Scientific, a leader in serving science. It is a supplier of analytical instruments, scientific, laboratory instruments and consumables. It also offers integrated reagents to enable integrated laboratory workflow solutions. The entity is the result of the coming together of Thermo Electron and Fisher Scientific in 2006. TFS in India clocked total sales of Rs 394.6 crore from its life science focused business. In fiscal 2006-07, the company's estimated life science business was Rs 246 crore. The company attributes its success on account of both organic growth as well as the acquisitions that it made during the last few years. The company also has a new vice president and general manager in Koos Van Der Steuijt, who will be engaged in integrating the different businesses of the company including the clinical services business coming up in Ahmedabad. Last year, TFS announced the acquisition of Qualigens Fine Chemicals, a division of GlaxoSmithKline Pharmaceuticals Ltd (GSK India). With 150 employees across the country, the turnover from this business alone was approximately Rs 96 crore in 2006. "Thermo was also looking for a well equipped team. This acquisition will be of great help for our chemicals, diagnostics and glass ware," said Dr G Ramakrishnan, managing director, Thermo Electron LLS, India Ltd. TFS recently announced the acquisition of the analytical technologies and environment instrumentation divisions of Chemito Technologies Pvt Ltd headquartered in Mumbai. Chemito manufactures its own analytical instruments, including gas chromatography, atomic absorption and UV-Vis spectroscopy. These two divisions of Chemito have annual revenues of approximately Rs 40 crore and will be integrated into TFS' analytical technologies business. "Chemito gives us a manufacturing base in Nasik and thus strengthen our analytical instrument base in India," Ramakrishnan said. The laboratory products division too has made a lot of progress during the past fiscal. "We have achieved a very strong double digit growth in India. Some of the key factors that contributed to this growth were increase in our field sales and service teams and strengthening of our supply chain initiatives to enhance the customer experience," said Amit Chopra, managing director-India, laboratory products, TFS. The division is also implementing a new customer relationship management (CRM) package. "Several of our service engineers are being continuously trained in our sites in the US, Europe and Asia and we have launched several new high-end equipment and consumables for the bio-processing, pharmaceuticals and healthcare industries," added Chopra. TFS has also focused on providing integrated workflow solutions to areas in scientific research, such as stem cell research, IVF and cell culture. "It is our endeavor to continuously partner with our customers to improve their R&D productivity and effectiveness," summed up Chopra. ]]> <![CDATA[BioSuppliers register growth higher than the biotech industry]]> https://biospectrumindia.com/news/95/2835/biosuppliers-register-growth-higher-than-the-biotech-industry.html https://biospectrumindia.com/news/95/2835/biosuppliers-register-growth-higher-than-the-biotech-industry.html Tue, 05 Aug 2008 13:07:00 +0530 New Page 1 BioSuppliers register growth higher than the biotech industry The trend of consolidation and growth at the 30 percent levels continued in 2007-08 too. The industry clocked Rs 3,135 crore ($784 million) in revenues during 2007-08, despite the rupee appreciation against the US dollar. While Thermo Fisher Scientific retained its No. 1 position for the third year in a row, Agilent Technologies jumped five places from its 2006-07 position to become the second largest player in the industry with Rs 277.77 crore in revenues. The Top 3 players in this year's survey-Thermo Fisher, Agilent Technologies, and Labindia Life Sciences-alone accounted for 30 percent share of the total market with total revenues of Rs 947 crore. The Top 20 companies collectively accounted for close to 70 percent market share. Industry shows a compounded annual growth rate (CAGR) of 40 percent in the past five years. Industry projected to cross $1 billion mark by 2010. Expected to register $2.8 billion in revenues by 2015. Top 20 companies account for 85 percent share of the market. Five companies register revenues in excess of Rs 200 crore. Top 10 companies account for 70 percent share of the total market. Top 5 companies generate 45 percent of the total business. The Top 5 companies collectively generate business worth Rs 1,421 core. Top 3 companies inch towards the Rs 1,000 crore mark. Nine of the top 20 companies are home grown companies and these nine account for 32 percent share of the total market. The 11 top 20 MNC companies account for 54 percent share of the total market. The Northern region is the largest contributor to the industry with total business of Rs 1,104.21 crore and accounted for 35 percent share of the pie.   South with total revenues of Rs 1,063.68 crore accounted for 33.93 percent share West's contribution was Rs 967.32 crore. Agilent is the leading player from the North with close to 25 percent share and is followed by Labindia with a similar share of the total pie of Rs 1,104.21 crore. The Top 5 players in North accounted for 81 percent of the total business generated by the companies based in the North. Waters India is the largest player in South with Rs 264 crore in revenues. Spinco Biotech with close to 20 percent market share is the second largest player from the region. Thermo Fisher is the largest player in the west and accounted for close to 19 percent share of the contribution from players in the region. ]]> <![CDATA[Is it end of inhalable insulin?]]> https://biospectrumindia.com/news/95/5015/is-it-end-of-inhalable-insulin.html https://biospectrumindia.com/news/95/5015/is-it-end-of-inhalable-insulin.html Tue, 05 Aug 2008 12:56:00 +0530 New Page 1 Is it end of inhalable insulin? In October 2007, Pfizer, one of the largest global pharmaceutical companies, took the market by surprise by announcing its decision to discontinue the production of Exubera [rDNA origin], the inhalable powder formulation of insulin for the treatment of diabetes mellitus or hyperglycemia (high blood sugar). Pfizer explained that: too few patients were taking Exubera and since there are other medicines available that lower blood sugar, Pfizer will stop providing Exubera. Three months later, Novo Nordisk, a world major in insulin drugs, threw in the towel for its inhaled insulin product candidate, AERx. The company said: it decided the product, meant to deliver inhaled droplets of liquid insulin, did not have adequate commercial potential, given the recent failure to attract patients by Pfizer's inhaled insulin drug, called Exubera. Additionally, Novo Nordisk spokesperson Mr Christian Qvist Frandsen said, "in simply looking at the market and the convenience of our device, we decided it is not really there". More recently in March 2008, Eli Lilly & Company, the promoters of the first synthetic 'human' insulin using recombinant DNA technology in the early 80s, Humulin, terminated the development of its phase III AIR Insulin Program for the potential treatment for Type 1 and Type 2 diabetes, in partnership with Alkermes Inc. The company noted that: this decision is not a result of any observations during AIR Insulin trials relating to the safety of the product, but rather was a result of increasing uncertainties in the regulatory environment, and a thorough evaluation of the evolving commercial and clinical potential of the product compared to existing medical therapies. Regulatory environment Earlier in January 2006, the US Food and Drugs Administration (FDA) approved the first inhaled version of insulin, Exubera, from Pfizer's stable using the technology developed by Nektar Therapeutics of San Carlos, California. This inhalable form of insulin was seen as a major breakthrough after Insulin as an injectable agent was discovered by Banting and Best in 1921, offering an additional tool in the battle to fight diabetes. After 11 years of development, Pfizer, in May 2006 launched Exubera in Germany, Ireland, UK and the US for clinical use in non-smoking adults with Type I or Type II diabetes, without lung (pulmonary) disease. This offered a new hope to millions of diabetics over injectable insulin. The launch of Exubera represented a paradigm shift from the earlier insulin injectable delivery system, due to a major technical achievement involving stabilization of large Insulin molecule to make it in a dry powder form. The new formulation with a particle size between 1mm and 5mm in diameter differed in route of administration, dosing units, and patient eligibility, which call for periodic testing for safety. Due to main effect on lung function, FDA made it mandatory for all patients to undergo a pulmonary function assessment prior to initiating the therapy with Exubera. Strange enough, most physicians treating diabetes do not have lung function testing machines in their offices and they refer the patient either to a specialist (pulmonologist) or to a center with testing facilities. This not only created a major hurdle for a patient to start on the new drug, but also raised an alarm in the minds of physicians on the drug's safety. It is pertinent to note that the FDA delayed its permission on Exubera for nearly two years, demanding additional safety studies before giving the green signal. The treatment was also limited due to unavailability of eligible patient pool. Nearly one-third of diabetic Type 1 and 2 patients were excluded from Exubera therapy at the screening level, due to smoking history and spirometry. Another 40 percent of diabetics who wanted to use Exubera were excluded from the treatment because of chronic lung disease. What went wrong? Physicians are generally known for their apathy to new technology. They are not willing to take on something new unless someone else tries it first. This reflects the lack of enthusiasm in doctors to understand how the device works and then teach the patients its proper usage. Further, majority of the healthcare payors across major markets were not convinced about the product's reimbursement method, and they conducted a cost-benefit assessment. These included Germany's IQWiG, which published a report on Exubera titled "No evidence of an additional benefit". It was followed by National Institute for Clinical Excellence in UK, highlighting that inhaled insulin is not recommended for the routine treatment of Type 1 or Type 2 diabetes mellitus. They said Exubera is for those who have a marked and persistent fear of injections and those who have problems with injection site (consequence of lipohypertrophy) despite support with injection site rotation. Other barriers to Exubera treatment apart from negative impact of reimbursement and low eligible patient pool include significantly large size of the device, bigger than most inhaled products; some patients found it embarrassing to use it in public as it resembled a bong for smoking marijuana. Additionally, Pfizer did not impart proper training of the inhaler device to the nurses and the certified diabetic patient educators who play an anchoring role in the diabetic patient management than physicians in deciding who to be put on insulin. Above all, the marketing of the product lacked the drive and enthusiasm as the company thought Exubera would sell by itself. Disasters followed: initial marketing of Exubera, like television advertisements, were late; samples were limited; and at the time of launch in the June 2006 session of American Diabetic Association meeting, the packaging facility in Terre Haut was not ready, resulting in a failure to ship the product in time. Cost vs Revenue In short, Exubera cost Pfizer a hefty $2.8 billion in pre-tax charges, while revenues were under $12 million. The company appeared to have been fighting a lost battle from the beginning. In a complete failure to win over prescribers, Pfizer went one step ahead. It not only stopped marketing Exubera, but also stopped manufacturing it, curtailing the hopes of thousands of patients who saw this product as a lifesaver, as well as those diabetic patients who were postponing insulin therapy to avoid injections. Thus the market for inhaled insulin products evolved and passed in the wink of time. After this decision to phase out Exubera, the company will be redeploying its dedicated Exubera workforce to other more profitable projects, and may have to phase out its Exubera manufacturing sites in the US and Germany, along with their employees. Consort Medical, a UK-based firm, had earlier won a contract to manufacture the Exubera device and the decision to drop the product will impact the company's profits by around $4 million next year. Pfizer also resolved its row with Exubera device and technology partner Nektar with a one time settlement of $135 million payment and returned all rights related to the product so that the device maker can hunt for a new partner. Exubera is the second disappointment suffered by Pfizer after the development of torcetrapib (drug to reduce cholesterol) was halted in December 2006 when phase III studies showed excessive mortality in the treatment group receiving a combination of atorvastatin and the study drug. Both these drugs were intended to contribute to Pfizer's top line and act as a possible shield to help buffer Lipitor losses (sales of over $13.5 billion) when it goes off patent in 2010, maintaining its lead position among the pharmaceutical conglomerates. Insulin as a class threatened? Other major companies like Novo Nordisk and Eli Lily have figured out that the FDA might apply the same restrictions as it did with Exubera and did not find it viable to go ahead. Interestingly Lily's press release mentioned two things: "Increasing uncertainties in the regulatory environment," and "Evaluation of the evolving commercial and clinical potential of the product compared to existing medical therapies". The statement highlights that insulin as a class of drugs could be threatened by the new class of drugs known as peptide analogs (incretin-based therapeutics). After all, the treatment landscape for Type 2 diabetes is set to change with the advent of a new class of drugs grouped under incretin-based (non-insulin based) therapeutics. In Type 2 diabetic patients, the insulin produced in the body is not sufficient to control blood sugar level. These patients are started with oral anti-diabetic drugs to maintain blood sugars along with lifestyle modifications. With the advancement of this disease, the high glucose level in the blood needs to be curbed with conventional insulin management. However, the new class of incretin-based therapeutics are likely to be used as intermediaries in whom oral anti-diabetic and insulin therapy are no longer effective. The novel incretin-based agents aim to close the existing treatment gap by removing the need to initiate insulin therapy early in Type 2 diabetic patients and hence are likely to eat into the insulin market. Further, these incretin-based therapies achieve a lasting reduction in HbA1c, and unlike insulin, do not cause low blood sugar (hypoglycemia), and are not associated with weight gain or weight loss. The emergence of this new group of anti-diabetics is likely to change the diabetes market by being a strong competitor to insulin treatment, which is efficacious even though complicated. Clinical efficacy: Exubera The efficacy of Exubera was studied in several clinical trials involving over 4,700 Type 1 and Type 2 diabetics and found to have similar efficacy as subcutaneous regular insulin or rapid acting insulin analogs in diabetics with Type 1 disease. In a study on inhaled insulin, a meta-analyses of six trials (three each of Type 1 and Type 2 diabetes) of inhaled versus rapidly-acting insulin injections concluded that glycemic control was equivalent. On the other hand, patient satisfaction and quality of life was better with inhaled insulin. Several studies have shown an overall improvement in quality of life, such as convenience in taking inhaled insulin many times a day, offering mealtime flexibility and no social stigma attached to its use in the society. Additionally, patients using inhaled regimen documented more positive perception of glycemic control and higher satisfaction rating, including physical and psychological wellbeing. It is pertinent to note that, if these results are translated into clinical practice then more diabetic patients may be willing to use inhaled insulin, resulting in better adherence with insulin therapy and overall improvement in glycemic control. Long term trials necessary Overall safety of this agent has been evaluated in over 2,500 adult Type 1 or Type 2 diabetic patients and around 2,000 patients were exposed to Exubera for more that six months and 800 patients for more than two years. Pulmonary Safety: All trials put together the incidence of respiratory adverse events less than two percent in any treatment group in controlled phase II and III clinical studies. Mild cough occurred within seconds to minutes of inhaled insulin and disappears over time and may be related to the delivery method including irritation from carrier of the active ingredient judged by its timing of occurrence. Around 1.2 percent of patients discontinued treatment due to cough studied in controlled clinical studies. Dyspnea (breathlessness) and other Respiratory Adverse Events were reported as mild or moderate. About 0.4 percent treated with Exubera discontinued treatment due to dyspnea and a small number of patients discontinued due to other Respiratory Adverse Events. In the lung function test, such as forced expiratory volume at one minute (FEV1), the carbon monoxide-diffusing capacity (DLco) seen in clinical studies declined slowly in the first several weeks of treatment but stabilized in studies of duration up to two years. Further in one study with Type 2 diabetic patients showed resolution in FEV1 six weeks after discontinuation of therapy. Long term studies including post-marketing surveillance trials are required to fully assess the effect of inhaled insulin on lung function. Malignancy: There have been reported six cases of new primary lung cancer (five cases in clinical trails and one case in post-marketing study) treated with Exubera when compared with one newly diagnosed case among comparator treated patients. There were too few cases to determine whether the emergence of these events is related to Exubera. Interestingly all patients who were diagnosed with lung cancer had a prior history of cigarette smoking. Due to the effect on lung function seen in short term trials, FDA made it mandatory that all patients should have pulmonary function assessed prior to initiating therapy and periodically with inhaled insulin, which includes spirometry (FEV1) and assessment of Dlco. MannKind, Abbott, Coremed-left in the fray The pharmaceutical industry since its evolution focuses to bridge the gap between current therapy and the unmet need by introducing novel drug with innovative technology in the from of devices aimed at different routes of administration. The development of inhalable insulin is intended to bridge the gap by providing convenience along with efficacy for diabetic patients who are postponing insulin therapy to avoid painful injections. Of all the insulin in the market, there are two key characteristics in insulin efficacy that are still unmet. Novel insulin need have a similar onset of action profile mimicking the internal (body's) insulin pattern both between meals (prandial) and during night (basal) to control blood glucose levels. A Type 2 diabetic patient cannot produce the first-phase insulin release spike in relation to meals, and end up releasing glucose from liver and absorb additional glucose from the food. Therefore an unmet clinical need is to mimic the internal first-phase insulin release spike closely as no insulin preparation on the market that mimic this spike. Likewise an ideal basal insulin preparation needs to have no peak in its metabolic effect and exhibits 24-hour activity to control blood sugar level in the body. Second challenge for an innovative product candidate is to address inter/intra-patient variability (unpredictability in the absorption of insulin formulations). California-based MannKind Corp, a small biopharmaceutical firm, with its Technosphere in late stage of development, is the only one left in the race to develop inhaled insulin after Novo Nordisk and Eli Lily dropped out. It is interesting to note that MannKind is developing this insulin system without a partner, and with no products on the market using its proprietary technology, its path to clinics may not be easy. Technosphere is likely to address one of the two unmet clinical need for insulin product development. According to the product profile available, it mimics the normal insulin secretion patterns and spike in the body response to meals effectively improving blood sugar level in a diabetic patient. Once this clinical benefit is proven during the phase III clinical trials, coupled with patient inhalation convenience, Technosphere might receive a reimbursement approval from the healthcare payors across the major markets after its expected launch in 2010. Insulin pipeline: Subcutaneous and Inhalable insulin top the list Currently, there are 12 candidates that are being developed in the insulin pipeline. These include, subcutaneous (3), topical-patch (2), oral (2), inhale (3), buccal/sublingual (1) and nasal (1) route of administration. Apart from Technosphere other late stage insulin pipeline candidates include VIAject (subcutaneous injectable formulation) and Oral-lyn (formulation, aerosol, buccal formulation), likely to be launched around 2010 to 2013. Among these two advanced insulin candidates, Oral-lyn, a buccal spray formulation, developed by Generex Biotechnology Corporation, using RapidMist immunomedicine platform, is currently in advance phase of development for the US and European market. However, it is available for sale in Ecuador for the treatment of patients with Type 1 and Type 2 diabetes and has received regulatory approval for sale in India. Generex has partnered with Shreya Life Sciences for marketing and distribution for Oral-lyn in the Indian market. Shreya is likely to launch the product in India in the second half of 2008. Weak outlook for inhalable insulin The outlook for innovative insulin products in the diabetes market, especially inhalable insulin, is not encouraging. Lack of physician enthusiasm about Exubera, reflected in the lower cost-benefit assessments by payors (Germany's IQWiG and the UK's NICE) has put the last nails in the coffin. In order to optimize the commercial potential of a novel mode of insulin application, the pharmaceutical companies need to focus on unmet needs, keeping in mind all key players: the physicians, patients and the payors. However, MannKind's Technosphere is likely to address the unmet need (mimic normal insulin secretion pattern) coupled with patient convenience; it may receive a partial reimbursement approval from the healthcare payors across the major markets after its expected launch in 2010. This could address some of the concerns regarding commercial viability of this product and convince all stakeholders to take Technosphere to clinics. (Dr Mir Khan has been tracking biotechnology and pharmaceutical industry since a decade now. He is an author of many industry white papers and reports on a number of companies from the US, European and Indian biopharmaceutical sector. From the last two years he is associated with the healthcare division of Datamonitor.) ]]> <![CDATA[Uttarakhand]]> https://biospectrumindia.com/news/95/1705/uttarakhand.html https://biospectrumindia.com/news/95/1705/uttarakhand.html Tue, 05 Aug 2008 12:29:00 +0530 New Page 1 BT Parks - North Uttarakhand Biotech Policy The State Government believes that the newly established state of Uttarakhand would benefit greatly from the direct intervention of biotechnological research, know how and associated tools for the sustainable development of the state and its economic upliftment in tandem with the preservation of its fragile but unique ecosystems, environment and the rich biodiversity. The areas which may be greatly (and positively) impacted by such applications/innovations and research are very wide ranging and may include diverse fields such as agriculture, floriculture and horticulture, medicinal & aromatic plants and forestry sector, soil fertility management, microbial products, traditional fermented foods and beverages, vaccine production, animal health including reproduction & nutrition, aquaculture, human health and welfare including balanced nutrition, as well as gene pool conservation and utilization, IPR related issues and the cleaner environment, to name a few.. Uttarakhand is a new state and has inherent strength in various fields of biotechnology and the objectives of the policy are to make Uttarakhand a front ranking State in the field of Biotechnology. To attain this overall goal, the objectives of the policy would be â€“ To map the rich Biodiversity of the state, including landraces and lesser known crops and create exhaustive/extensive data base to enable ex situ & in situ conservation, scientific management and prevent reckless exploitation. To intensify the R & D work in potential areas of Biotechnology and upgrade the infrastructure of R & D institutions to generate quality research and to foster industry linkages. To promote the human resource development in this field through upgradation of the existing as well as and setting up of new educational institutions. In the realm of plant biotechnology, leverage on the existing knowledge base to promote research, which meets the needs of Indian farmers becoming competitive and enable them to take advantage of what are today closely held technologies. To promote medicinal and aromatic plants/herbs of which abundance is found in Uttarakhand to enable their natural growth as well as scientific promotion of the pharmaceuticals, nutraceuticals and such other industries. To encourage the entire spectrum from low-end industries which are capable of going to the farmers field to the highest end. To spread awareness about the investment opportunities, in Biotechnology and allied sectors, in the state of Uttarakhand. To this end, proactively promote setting up of biotechnology industries in the State whether in a industrial Estate mode or dispersed in smaller pockets throughout the State, and to outline a set of incentives and concessions for the Bt industry to attract investment.. To provide a suitable institutional framework which is a mix of the best available talents, with proactive Governmental support and facilitation. The detailed road map In the pre-;launch allotment, 50 acres of land had been earmarked for this purpose. The remaining 450 acres of land in the Bio-IT Park was planned to be developed through a Developer. SIDCUL has finalized lease deed with the following 10 Biotech Units. A few companies have already started construction work in the B.T. Park. Applications of the following BT/IT companies are under consideration of SIDCUL for allotment of land in the BT/IT Park: Vaishnavi Biotech Venkteshwari Hatcheries Vedalife Anil Kumar Genetic Biotech Asia Shukla Infotech Biotech and Food Syste Sakuntala Software Pvt. Ltd. Construction of C.E.M.B.(Center of Excellence in Mountain Biology) Building ; its Laboratory Block, Seminar Hall and Library completed. The initial proposed work plan of CEMB is in four major areas, namely medicinal plants, DNA finger printing, plant tissue culture and fermented foods & beverages, both in terms of R & D as well as a service provider for the State of Uttarakhand. An updated version about the State Biotechnology Programme was loaded on the NIC server located in the Secretariat Building at Dehradun.   ]]> <![CDATA[Chhattisgarh]]> https://biospectrumindia.com/news/95/1454/chhattisgarh.html https://biospectrumindia.com/news/95/1454/chhattisgarh.html Tue, 05 Aug 2008 12:26:00 +0530 New Page 1 BT Parks - North Chhattisgarh Chhattisgarh has been making a constant effort for all round development of the state in the biotechnology. Chhattisgarh enjoys a unique position in the fields of agriculture, healthcare, and sericulture. The state houses an important part of India's biodiversity, approximately 44 per cent of the geographical area of the state is under forests cover. Biotechnology policy of Chhattisgarh was formulated in the year 2003. Since then, the Government of Chhattisgarh has been making constant effort for all round development of State in this arena. For Industrial development, state has prioritized the 'BT-Park' as the backbone of the concept. Tasks identified in these Bt Parks, besides providing employment to local residents, are value addition/consumption of local resources, develop infra-structure for industries, and develop system of local procurement. The major prioritized areas are- agriculture, nutraceuticals and pharmaceuticals. Time-lines After the constitution of Chhattisgarh infotech and biotech promotion society (Chips) in Chhattisgarh, need for a local BT Park was felt. BCIL New Delhi was given the task to propose a detailed project report (DPR) for this. Land of 50 Hectares is identified for the park and 2-3 companies are being tested on pre-identified norms, to be awarded as the anchor company. Time needed may be around 6 months. Investments required The budget of the park mentioned in DPR is approximately Rs. 38 crore. Private organizations will be encouraged to invest in the park. Companies will be invited in two ways: in the form of an anchor company, or a subsidiary company working in terms and conditions agreed upon with the anchor. Support in the form of subsidies, from different funding agencies and departments of Government of India will be initiated (wherever available/applicable) Equity will be decided by way of MOU/Agreements with the anchor company or the funding agency. Future plans It is planned that initially, the anchor company will invest, in form of purchasing and development of land, then will be free to resell it to BT companies (strictly). Government will facilitate for tax benefits, subsidy in infra-structure, confirming un-interrupted power supply, insuring broadband connectivity, increasing transport lines and intensity etc. Also, up to permissible levels, government will empanel companies of the park for government procurements of goods and services.   ]]> <![CDATA[Rajasthan]]> https://biospectrumindia.com/news/95/1922/rajasthan.html https://biospectrumindia.com/news/95/1922/rajasthan.html Tue, 05 Aug 2008 12:22:00 +0530 New Page 1 BT Parks - North Rajasthan The Bt park in Rajasthan will be the focal point of technological innovation for knowledge-based biotechnology enterprises. As part of the mandate of the Department of Science and Technology to implement the directives of Biotechnology Policy of Rajasthan, DST intends to establish a Biotechnology Park at Jaipur in a land piece of approximately 50 acres. This park will be established with the aim to promote biotech entrepreneurs and to bring biotech investment in Rajasthan by providing incubation facility at Park. Implementation Methodology: The park will provide built up space for biotechnology based any organization which is conducting research in life science, training, manufacturing including bioinformatics, pre clinical and clinical studies or any similar allied activities. The project will be implemented through selected vendor based on the report prepared by the Consultant on BOT/BOOM/PPP basis. Base work for establishment of Biotechnology Park through PPP model is being worked out, at higher level. The Biotechnology Park will have following objectives: To be the focal point of technological innovation for knowledge-based biotechnology enterprises and to provide sustainable linkages between the industry, research institutions and academia The park will be a biotech cluster being planned by the Rajasthan government. It would support biotech units with common infrastructure. It may comprise eight to nine biotech incubators in first phase, covering a total area of 50 acre. The cluster will involve an investment of around Rs50.00 crore. The infrastructure support would be comprehensive, right from advance computing facilities to treated water necessary for biotech research. The incumbents of park would pay for the infrastructure services. The probable areas of activities and incubation facilities may include: In initial phase incubation facilities may be provided for tissue culture, Bio-fertilizer, extraction and distillation units, vermicomposting units. Facilities enabling work in the areas of immuno-diagnostics, recombinant therapeutics, industrial enzymes, and basic facilities including laboratory benches, water, power and drainage. Genomics Unit: Aims to make high-end and sophisticated genetic marker-based screening tools accessible to everyone at an affordable price. More specifically, it may: (i) develop and commercialize low cost in situ synthesized custom microarrays (ii) conduct research to extend its portfolio of commercializable molecular biology techniques relevant for developing nations, (iii) develop and commercialize a hand-held point-of-care real-time PCR device (Gene Analyzer), (iv) provide services and products related to microbial diagnostic biochips, and (v) provide hands on training in emerging areas such as micro arrays, molecular biology, bio-informatics, and nanotechnology. Health Care center may be established for setting up a unit for testing and development of Diagnostic Kit A state of art facility may be developed for the production of plants by tissue culture method. Economically important plants of Rajasthan and floriculture may be developed through tissue culture techniques which make them most viable under drought conditions of Rajasthan. A GMP stem cell facility for cell based therapeutics. Incubation may be developed for manufacturing equipment and instruments for bio-processing business. Incubation facility may be developed for undertaking R&D, product development, process development, scale-up, pilot plant and production for commercialization of new biotech products for health use including therapeutics, diagnostics and vaccines. Biotech Services, may be setup for Human DNA Bank, and setting up of Umbilical Cord Blood Bank. The Biotechnology company at Biotech Park may focus on plant biotechnology proposes to produce biopharmaceuticals of non-therapeutic use. Future Plans State Government will lay main emphasis on establishment of biotech units like: Micro-propagation of tissue culture plant varieties which are economically viable for Rajasthan, drought and salinity resistant. R & D units of pharma industry and live stock base research. Human DNA bank centre for DNA based identification system. Vermicompost / bio-fertilizer units R & D units taking up Camel milk and Camel products, working on medicinal value of Camel milk.   ]]> <![CDATA[Himachal Pradesh: On the brass track]]> https://biospectrumindia.com/news/95/6250/himachal-pradesh-on-the-brass-track.html https://biospectrumindia.com/news/95/6250/himachal-pradesh-on-the-brass-track.html Tue, 05 Aug 2008 12:17:00 +0530 New Page 1 BT Parks - North Himachal Pradesh: On the brass track The biotechnology park in Himachal Pradesh was initially proposed on 134 acres of land at Kotla Barog on Solan-Rajgarh Highway, 22 km from Solan and 8 km from University of Horticulture and Forestry-Nauni, Solan. However, based on the feed-back from the interested investors, the Biotechnology Park/BT Industrial Cluster will now be established at Aduwal on Nalagarh-Swarghat National Highway (around 7 km from Nalagarh and 40 km from Pinjore, 60 km from Chandigarh). The state government. has decided to develop this area as a leading biotechnology hub which will house biotechnology-based industries only. To start with, out of around 400 acres, 35 acres of land will be made available immediately whereas the rest of land will be provided in due course of time. The state government. will provide basic infrastructure and other facilities like road, power, water and other amenities at the park site. The state government has also initiated efforts for providing basic facilities at the park site and the process of selection of private partner has also been initiated. DBT-GoI has allowed extension of the project until March, 2009 and the state government is committed to complete all required formalities so as to start working for establishment of the Park by the end of 2008. Collaborations The state government. has received offers from various investors from within India and abroad for collaborations for various projects. which are being examined at present. The state will soon come-up with open tender for selection of consultant and the private investors who may like to join hands with the government as primary promoter, collaborator, partner or a tenant in the park. Investments The state is expecting an investment of more than Rs 200 crore in the first phase of biotechnology park and as soon as the promoter is selected, the final details will be available. Besides above, several business houses have desired to invest in the Bt-related activities not only at BT Park site, but at other locations as well and the total investment will go quite high (approx. Rs 1000 crore). Thrust areas Biotechnology Incubation Centre (BTIC) The BTIC will be funded by DBT-GoI and the State Government., but the private promoter will be responsible for its operation. As per sanctioned activities the BTIC will have total financial outlay of Rs 38.66 crore. The following activities will be undertaken in the first phase: Tissue Culture and Hardening Facility Commercial Cultivation and Processing of Aromatic Plants Pilot cultivation of high value medicinal plants Biofresh Project and Technology aided Food Processing. Biotechnology Industrial Cluster The biotechnology industrial cluster will be supported by BTIC and will house the industrial units related to core biotechnology activities. Although, the promotion of bioresource-based industries will be the main mandate, however, following thrust areas have also been identified: Aromatic Oil, Medicinal Plant Formulations Biofertilizers, Biopesticides, Biofuels, Vermicompost Fermentation /Bioprocess derived products Nutraceuticals, Herbal Concentrates and other health care products Biopharmaceuticals, Biochemicals Bioresource Utilization (Temperate Fruits, Off- season vegetables, Microbes, Mush rooms and other plants and animals) Industrial Enzymes ]]> <![CDATA[Lucknow: The Catalyst For UP]]> https://biospectrumindia.com/news/95/1408/lucknow-the-catalyst-for-up.html https://biospectrumindia.com/news/95/1408/lucknow-the-catalyst-for-up.html Tue, 05 Aug 2008 12:16:00 +0530 New Page 1 BT Parks - North Lucknow: The Catalyst For UP The setting up of the Bt park in Lucknow has boosted the biotech activity in the State The Lucknow Biotech Park was jointly setup by the Department of Biotechnology, Government of India and Department of Science and Technology, Government of Uttar Pradesh in collaboration with the Council of Scientific and Industrial Research, New Delhi; Indian Institute of Technology, Kanpur; local universities and industries. It is a technology incubator plus model. The park buildings were completed in July 2006 and in a few months time all available constructed space and available land has allocated to entrepreneurs. While states like Andhra Pradesh, Karnataka, Maharashtra and Gujarat have taken a great lead in biotechnology, UP is comparatively new in their comparison. However, the setting up of the park has boosted the biotech activity in the state. The companies in the park are utilizing the common facilities as per their requirements. The park is playing a major role in providing them advisory and consultancy services. Nextgen- Biofertilizers and Aroma Products have expanded their activity outside the park in biofertilizer. Similarly the park has paved the way for launching of two new companies - Green Oil, New Delhi and U.P. Bioenergy Pvt. Ltd, Lucknow outside the park in the area of biofuel energy. The park plays an important role in the initial establishment of the startup companies by providing information about possible business avenues based on the facilities set up at the incubator center of park, sourcing of technologies and state of the art facilities available with various national R&D institutions, Universities and medical institutions, provides access to expertise available with renowned and accomplished scientists. It also provides them information about the facilities and incentives available under the Government of India and state government biotech policies, availability of special grants, schemes and loans as well as information about requirements for registration and obtaining IPR. Expansion Plans The future plans of park includes, constructing more ready to use laboratories keeping in view the high demand from new start up companies; setting up of a commercial solvent extraction plant for obtaining lead molecules in a public private partnership mode; setting up common facilities of safety evaluation and toxicity testing, analytical facility for food processing industries in public-private partnership; establishing new protocols for high yielding varieties of the Jatropha curcas plants and providing good planting material with particular emphasis on Jatropha and Banana; providing industrial biotechnology training in areas of molecular biology, bioinformatics, human DNA banking, agribiotechnology and providing Agri Biobusiness opportunities for rural development. Companies / Institutions utilizing the incubation facilities The limited constructed space of approximately 20,000 sqaurefeet. available with the park has been leased out to the following entrepreneurs for innovative research and services: AquaBioChip Genomics (India) Pvt. Ltd, Lucknow Aims to make high-end and sophisticated genetic marker-based screening tools accessible to everyone at an affordable price. Clintech Research India Pvt. Ltd., Lucknow A USA-based Clinical Research Organization (CRO) has set up their office in the Biobusiness Centre. Cognate Bioservices Inc., USA A GMP stem cell facility for cell based therapeutics. Plans for modification of two room to meet the GMP requirements are being prepared. ACS Bioinformatics, Lucknow The company undertakes R&D activities in the field of biotechnology services; and provides bioinformatics and patent filing services. HH Biotechnologies Pvt. Ltd, Agra A North India-based biotechnology company with a special focus on plant biotechnology proposes to produce biopharmaceuticals of non-therapeutic use. IQRA Biotech Services, Lucknow Has setup Human DNA Bank, first in this part of the country and proposes to setup an Umbilical Cord Blood Bank. Sheel Biotech Ltd., Manesar Plant Tissue Culture, R&D, Producing Banana, Bamboo, Gerbera and other plants. Software Technology Parks of India, Lucknow Provides lease link services, internet services and support for creation of central facility for computing. Sepragen India Pvt. Ltd., India A USA based company registered in India as Sepragen India Pvt. Ltd. will be manufacturing equipment and instruments for Sepragen's existing global bio-processing business.     Facilities being operated under Public-Private Partnership mode The following facilities are being run under Public-Private Partnership mode: Distillation and Vermicomposting Units Next Gen â€“ Biofertilizers & Aroma Products, Lucknow Biofertilizer Unit Next Gen â€“ Biofertilizers & Aroma Products, Lucknow Tissue Culture and Hardening Facility Sheel Biotech, Manesar, Haryana Entrepreneurs to whom developed plots have been provided The vacant land of about 3.25 acres available with the park after setting up the common facilities and technology incubator has been provided to the following entrepreneurs for innovative bio-business and services: Chandan Health Care Ltd., Lucknow The company will set up a unit for testing and development of diagnostic kit. Life Care Innovations Pvt. Ltd., Gurgaon The company shall undertake R&D, product development, process development, scale-up, pilot plant and production for commercialization of new biotech products for health use including therapeutics, diagnostics and vaccines. IQRA Biotech Services, Lucknow This company would be setting up a human cord blood bank.   ]]> <![CDATA[Goa's Biotech Dreams Washed Away]]> https://biospectrumindia.com/news/95/6682/goas-biotech-dreams-washed-away.html https://biospectrumindia.com/news/95/6682/goas-biotech-dreams-washed-away.html Tue, 05 Aug 2008 11:34:00 +0530 New Page 1 BT Parks - West Goa's Biotech Dreams Washed Away Lack of interest by the State Government coupled with agitations by local groups have slackened the development of Goa's biotech policy. The state of Goa had evolved an Industrial Policy in 2003 and has recently put in place an IT policy to provide the framework for accelerated growth of its knowledge based industries. Following which, talks were doing the rounds to implement a policy support to augment the growth of the biotech industry in Goa given the mammoth opportunities the state has to offer in terms of agriculture , pharmaceutical, food processing and marine biotechnology. However, there has been a huge gap between the formulation and the actual execution of policies from the state government's side, whereby now the wheels of progress for the biotechnology industry in the state has totally come to a standstill. As envisaged by the state government before, the biotechnology policy initiated would concentrate in areas of agriculture, healthcare, industrial biotechnology, environmental biotechnology, bioresources utilization, bioinformatics, bioservices, marine biotechnology . It has also been envisaged that private-public partnership would play a key role and that accordingly, appropriate allocation will be made in the state's budget. The state would develop mechanisms to work in close collaboration with the central covernment. The policy would also ensure that the state government would also offer special grants to set up or upgrade research and development facilities. It also aimed to focus on areas like human resources, infrastructure, giving incentives and financial support. The government also put forward to set up a high-powered coordination committee to ensure clearance of biotechnology projects. However, external circumstances or rather agitations from the local groups have pushed Goa's biotech dreams in the background. Says Dr Sangam Kurade, Vice President, Goa State Industries Association, "Goa State Industrial Association (GSIA) has time and again reminded the State Government to implement the Industrial Policy (2005) and Biotech Policy (2006) With the change in government, 14 months ago and frequent changes in the post of Director of Industries has had impact on micro, small and medium scale units setting up or expanding their base. Many of them dependent on large mother units existing in Goa. State Chief Minister having Industrial portfolio has not helped either." Lack of any development in the biotech industrial front has led to prospective investors backing out. Comments Dr Kurade, "Goa seems to have lost the charm to the investors and ceased to be an investor's friendly estate. Besides policy matters and government apathy, single most factor seems to be opposition to any and every developmental activity by newly formed committees, forums and NGO's/fronts. It has had its most severe impact on the industrial development of the state." The recent scrapping of SEZs by the State Government has also proven to be a major setback to biotechnology in Goa. ]]> <![CDATA[Gujarat: Going from Strength to Strength]]> https://biospectrumindia.com/news/95/1166/gujarat-going-from-strength-to-strength.html https://biospectrumindia.com/news/95/1166/gujarat-going-from-strength-to-strength.html Tue, 05 Aug 2008 11:28:00 +0530 New Page 1 BT Parks - West Gujarat: Going from Strength to Strength Gujarat is rapidly as far as its Bt parks is concerned. The aim is not just to attract big players to the park but also promote local companies. The Akruti Gujarat Biotech Park is a joint venture between the Gujarat government, The Chatterjee Group, and Akruti City Limited. For this park, the three entities came together to form the Gujarat Akruti TCG Biotech Ltd (GATBL). The state government has a 11 per cent of equity stake, Akruti the lead promoter holder is holding 66 per cent and TCG has a 23 per cent stake. Investment is to be done in three phases. Total investment by the Government of Gujarat, for Phase 1, was Rs 10 crore while for Phase 2, Akruti has committed to the government a total cost of Rs 200 crore. Spread across 714 acres of land, the park is located in Savli in Vadodara, which is around 20 km away from the airport and 8 km from the Ahmedabad â€“ Vadodara Express Highway,and is located amidst a cluster of biopharma companies(spread across a a periphery of 50 km). "Park components includes, incubation centre which will house modular wet labs , common equipment library , pilot plan , plant tissue culture facility, animal tissue culture facility and a green house. The guidelines strictly asserts that no manufacturing units will be permitted within the park," says Ajay Pawar, GM, Engineering, Akruti Gujarat, Biotech park. Development of the park is divided into three phases out of which phase one has already been completed by the Gujarat Government (development of basic infrastructure) and now Akruti has taken up the development of Phase 2. However, Akruti was also involved in Phase 1 developments along with the state government, which was for purely marketing purposes. Says Akshay Kumar Saxena, mission director, GSBTM, "There are 16 companies who have applied , of these 6-7 are new ones and 3 are local companies. We also want local players to come to this park so that they can enter the biotech space. There are also1-2 MNC companies in the loop." Also 15 per cent of the land has been allotted for commercial development. For phase two, Akruti will now be developing around 131 acres of land. The master planning of the park was drafted by Australian-based agency HBO+ EMTB (who also designed the Dubai park) and has been submitted to the Government . This park has a SEZ portion and a non-SEZ zone. "The non-SEZ zone is close to 32 acres out of which 26 acres is occupied by the 2 companies one of the two being a MNC," adds Saxena. There have been major hiccups over the last one year, as far as the SEZ issue is concerned which has led to a delay in further developments. The Government of Gujarat is also developing an incubation center. For this centre again, they have taken the help of Akruti who have taken up the task of designing the facility and a Rs 4 crore facility is likely to come up by the end of the year. " The complete design is finalized, we have selected the consultants. It has all the components like microbiology , biochemistry lab and lab cell culture," adds Saxena. Akruti and the Gujarat government has mapped a route of marketing the Bt park which will be done not just by attending conferences(domestic and international), but also wooing NRI entrepreneurs who have been showing interest in investing in Gujarat lately and also keeping a close tab on the major international developments in the biotech industry. "We have also appointed an Italian delegate to promote our park in Italy. This is with the intention to ensure international firms setting up bases in the Bt park. Two MNC giants have already have discussions and with the government," adds Pawar. Gujarat is now on the move towards setting up an agri-biotech park. "We have identified 3-4 locations and carried out the feasibility studies We are coming up with 4 small agri-biotech parks. The state governments approval is awaiting, then we will think whether to go to state agencies or go to DBT for funds," comments Saxena.   ]]> <![CDATA[Maharashtra : Need for Acceleration]]> https://biospectrumindia.com/news/95/3691/maharashtra-need-for-acceleration.html https://biospectrumindia.com/news/95/3691/maharashtra-need-for-acceleration.html Tue, 05 Aug 2008 11:04:00 +0530 New Page 1 BT Parks - West Maharashtra : Need for Acceleration Unlike its neighbouring state, Gujarat, developments of Maharashtra's Bt parks has been moving at a slower pace Setting up of Biotechnology Parks which comes under the Maharashtra Biotechnology policy 2001 is an attempt by the state government to develop adequate infrastructural facilities to augment the biotechnology industry within the state (The biotech policy of the state is in the process of getting revised). The idea again is not just to set up infrastructural facilities but also to attract more players- domestic as well as international companies to the state. Maharahstra has set up two large scale Bt Parks namely the International Biotech Park at Hinjawadi, Pune and the Agri-Biotechnology Park at Jalna. International Biotech Park, Hinjawadi, Pune The park is a joint venture between Maharashtra Industrial Development Corporation (MIDC) and The TCG real estate. TCG has an 88 per cent stake in this park while MIDC holds the remaining 12 per cent. It is spread over 136 acres of land and located on the Mumbai-Pune Highway which is 5 kms from Pune. At present, land in this park has been allotted to Emcure Pharmaceuticals, Centaur Pharma, Phyto Actives Pvt Ltd, Hikal Pharma, Novartis(India) Ltd, Hikal Technologies, Chembiotek Research, Kard Scientific and Advantium (Research service organisation). Venketeshwar Hacteries Ltd and Shreya Biotech presently have their units under construction while production has already kickstarted for Emcure Biotech and Emcure Pharmaceuticals . This park will have an incubation centre,multi tenant campus , built to suit facilities, bioinformatics, education and training, clinical research. Investment for this park is slated to take place in three phases and as of now TCG has completed one phase in terms of infrastructure development and access to basic amenities. Says a TCG source, " The main advantage of this park is that it is close to the Mumbai-Pune express highway, it is located in a the knowledge capita of Pune,where we have a lot of IT companies located within that area, there is institutional connectivity both academic and industry and lastly physical infrastructure." The park offers to allot plots for research centers, pilot plants as per the requirements of the tenants. "Here there is no manufacturing facilities to be allowed. The government has allotted strict guidelines as to the activities that are to be followed by the tenants for which they have appointed two agencies. Companies applying and their activities will have to go through those agents and once these agencies give the green signal we can lease out land to them," says Prasanta Biswal, CEO, International Biotech Park, and TCG. The total cost of investment was initially estimated to be Rs 215 crore. "We thought that companies coming in would put in their own investments but then we saw that demand for space goes up and at the same time small companies cannot put in all their investment in a building since they have to invest in equipment which is equally important. So now we have already Rs 100 crore now. We are at the fag end of phase one and we are thinking of innovative ways of financing and building facilities," adds Biswal.   Absolute Confirguration for the park includes: Plotted Development - Land Genesis Square â€“ multi tenant campus for bio-science labs Chrysalis Enclave â€“ built to suit campus for research labs from "bench to the bed side" Bio Resource Centre â€“ shared facilities, incubation with business assistance(not yet operational) Social Infrastructure and Services   There is also an incubation center which is coming up. each laboratories of 1000 sqaure feet. "Since 32 acres of this portion of the park is awaiting for notification, there was a delay. We have an MoU with different clients and once we have the notification we can go ahead with the building of labs and multi tenant buildings," adds Biswal. Agri Biotechnology Park, Jalna The Agri Biotechnology Park is another initiative of MIDC to boast up the Bio-agricultureindustry in Maharashtra. Located at Jalna (near Aurangabad), the seed capital of Maharashtra, the total land earmarked initially was around 153 acres now it is 124 acres. Work for this park commenced in 2003-2004. The park will be declared as an industrial township and the major thrust areas of the park will be gene discovery, bioremediation, fermentation technology, post harvest technology, bioinformatics and diagnostics. Major units in the park includes names in the industry like Mahyco Research Foundation(Research), Balaji Bio-Fertilizer (Bt Cotton Seeds, Bt Grain Seeds), Nirmal Seeds (Seed processing), Krishidhan Seeds Ltd, (Hybrid Seeds), Sharda Biotech (Hybrid Seeds, Bio-degradable fertilizers), Mohodaya Hybrid Seeds (Seed processing), Jindal Agri Tech Company (Research production of hybrid seeds) and Desigen Diagnostics (Biotech equipments). An MoU has been signed with Mahyco Research Foundation (MRF) to design and conceptualize the park. MRF will also develop its research facility within the park. The MIDC has given a number of incentives and benefits which includes 100 per cent stamp study exemption, agricultural biotechnology companies will be given power at an agricultural rate , exempted from paying electricity duty, captive power generation will be permitted, capital subsidy for small scale Bt units, refund of Octroi and similar levies, twice the admissible FSI for BT units. However unlike its counterpart in Pune, this park has not picking up in the way it was planned by the institutional authorities. "A lot of people have purchased the land but have not developed it," says a source. Moreover industry experts also point out that unlike purely biotech industries, agriculture is not a promising growth area. In fact a leading promoter confides, "We were approached by MIDC to be involved in this agri-biotech park, But it is too much of a risk to undertake."   ]]> <![CDATA[Tamil Nadu: Small but successful]]> https://biospectrumindia.com/news/95/2451/tamil-nadu-small-but-successful.html https://biospectrumindia.com/news/95/2451/tamil-nadu-small-but-successful.html Tue, 05 Aug 2008 10:55:00 +0530 New Page 1 BT Parks - South Tamil Nadu: Small but successful The State Government of Tamil Nadu is realizing the immense potential of biotechnology for innovative technological development and employment opportunities TICEL Bio Park Tamil Nadu is the first state in India to bring an exclusive biotech policy in September, 2000 for the economic development of the state integrating the bioresources and the technical capabilities available within the state. List Of Clients at Ticel Bio-park 1. Central Leather Research Institute (CLRI) 2. SGS India Pvt Ltd. 3. TTK-LIG Pvt Ltd. 4. Operon Biotech Pvt Ltd. 5. ABL Biotechnologies Ltd. 6. Frontier Tissue Line Pvt Ltd. 7. Huclin Research Ltd. 8. Retailwave Technologies Pvt Ltd. 9. Sanmar Speciality Chemicals Ltd. 10. Histogenetics. 11. Hydrolina Biotech Private Limited. 12. Actavis Pharma Development Centre (P) Ltd., Realizing the immense potential of biotechnology for innovative technological development and employment opportunities, Tamil Nadu came up with the TICEL Bio Park established in Chennai, and is in operation since November, 2004. Support / financial assistance (equity / term loan) was provided by TIDCO, TIDEL, Indian Bank, Karur Vysya Bank and Bharat Overseas Bank. TICEL acts as a focal hub for Biotech R&D industry in major domains of biotechnology such as medical biotechnology, nutraceuticals, agricultural biotechnology and bioinformatics. Infrastructure TICEL Bio Park offers world class infrastructure for biotech R&D, implemented in 5 acres of land in Chennai at a capital outlay of Rs.625 million (US$ 12.5 million) has now achieved 100 per cent occupancy with National and International clients. The Bio Park has proposed a Bio Resource Centre to offer facilities for wet labs for fermentation & microbiology, downstream processing, molecular biology, plant tissue culture, animal tissue culture and analysis. Tenancy Area The tenancy area has 74 modules of 1525 square feet each, available for clients to develop their own customized R&D labs of BSL2 standards, upgradeable to BSL3, in accordance with GLP standards. The park also allows its clients to install their facilities appropriate to perform their independent research and development activities. ]]> <![CDATA[Andhra Pradesh: On Fast Track]]> https://biospectrumindia.com/news/95/2586/andhra-pradesh-on-fast-track.html https://biospectrumindia.com/news/95/2586/andhra-pradesh-on-fast-track.html Tue, 05 Aug 2008 10:42:00 +0530 New Page 1 BT Parks - South Andhra Pradesh: On Fast Track The State is one of the first in the country to kickstart the BT parks strategy. Capital city, Hyderabad provides a unique ecosystem for biotechnology research and manufacturing by being home to some of India's premier scientific and research establishments, bulk drugs manufacturing units, biotech companies, hospitals, and healthcare networks. Shapoorji Pallonji Biotech Park Given the state's bountiful bio-resources, the Andhra Pradesh government envisioned the development of India's first state-of-the-art Biotech Park which is now spread over an area of roughly 300 acres. The objective of the park is to be the nerve center of technological innovation for knowledge-based biotechnology enterprises and to provide sustainable linkages among industry, research institutes and academia. Phase - I Clients List Albany Molecular Research Centre Pvt. Ltd Avesthagen Ltd Biogenex Life Sciences Biomax Life Sciences Ltd Dr. N R K Bio-Tech Pvt. Ltd Genotex Intl (India) Pvt. Ltd. Indigen Healthcare Pvt Ltd (formerly Indigen Biotech Pvt. Ltd.) Issar Pharmaceuticals Pvt. Ltd KCP Biotech Ltd Pasura Life Sciences Pvt. Ltd. Sami Labs Ltd Shakti Bio Systems TATA Chemicals Ltd Vimta Labs Ltd Vimta Specialities Ltd Phase - II Clients List Biological E. Ltd Issar Biopharma Issar Zemogens & Nutraceuticals Pochiraju Industries Ltd Saamya Biotech (India) Ltd Sandor Proteomics Pvt Ltd Unique Biotech Ltd Uni-Sankyo Ltd Wet Labs - Clients Laxai Avanti Life Sciences Pvt. Ltd Symphony Pharma Life Sciences Pvt Ltd The park is being developed in two phases, which totally cover an area of 300 acres. Besides freehold developed plots for establishing manufacturing or research facilities, the park offers wet labs and also houses a state of art technology incubation center with a pilot plant and analytical equipment, which would be available for clients on rental basis. Thirty companies, including five US based research units, as well as leading biopharma and contract research organizations have already booked space in the park, which now enjoys full occupancy. The state government has initiated measures for allotting an additional 100 acres of land for the third phase of the project. A clear advantage for the park tenants is that the state government has set up an administrative mechanism to facilitate single window clearance of proposals. Industries in the park would also enjoy certain fiscal benefits such as nominal sales tax of 1 per cent for the next seven years and waiver of stamp duty and registration charges for their land and building transfers. Besides, for financial support to such units, the state government has set up the biotechnology development fund and is also financially supporting the APIDC Venture Capital Fund. In order to provide networking opportunities to its clients, the park has forged alliance with leading research institutions in India as well as biotech organizations abroad. The park is a member of International Association of Science Parks as well as Biotechnology Industry Organization, USA and has agreements for mutual collaboration with the Research Triangle Park, USA, Technologie Park Heidelberg, West Germany and the Biotechnologie Park Luckenwalde, New Berlin. Discussions are also underway with Imperial College London, the Indian School of Business and the University of Hyderabad for collaborative programs in entrepreneurship as well as for providing mentoring and business support service to companies incubated in the Park. ICICI Knowledge Park Launched by ICICI Bank Ltd, in partnership with the Government of Andhra Pradesh, the ICICI Knowledge Park is committed to facilitating business-driven Research & Development. The park has a Knowledge Network, aimed at facilitating collaborative research and knowledge sharing with key academic and research institutions in the country. This enables the resident companies to take advantage of existing competencies in these organizations thereby reducing time and cost of research. A key component of the knowledge network is a virtual information centre that provides a database of network members, their library catalogs and online access to international and national databases. The park co-ordinates service delivery from the network institutions to park tenants. Currently there are 19 companies doing R&D in various areas of the pharmaceutical value chain. 1 Aptuit Laurus 2 Daicel Chemicals 3 E.I.Dupont India 4 EPR Pharmaceuticals 5 Indigene Pharmaceuticals 6 JK Agri-Genetics 7 Matrix Laboratories 8 Nektar Therapeutics 9 CJ Cheiljedang Corporation 10 Onan Biotech 11 Ortin Biotech 12 Regain Biotechnology 13 Vrinda Life Sciences 14 GVK Biosciences 15 Helvetica Industries 16 LAXAI AVANTI Life Sciences 17 Mithros Chemicals 18 Sai Advantium 19 United States Pharmacopeia (USP) India The park is a member of the International Association of Science Parks (IASP), head-quartered in Spain and also a member of the Indian Science & Technology Entrepreneurs Parks and Business Incubators Association (ISBA). It is associated with Society for Technology Management (STEM) which provides facilitative environment for smooth technology transfers and technology management. The park also has a tie-up with the Apollo Hospitals Group, , to support companies engaged in clinical research. ICICI Knowledge Park has also set up a Life Science Incubator (LSI) with an incubation space of around 3,200 sq.ft. for eight incubatees to encourage and nurture startup companies and spin offs in pharmaceutical and biotechnology related areas with the support of National Science and Technology Entrepreneurship Development Board (NSTEDB) of Dept. of Science and Technology (DST) Government of India. ICICI Knowledge park leases ready-to-use labs for renewable short period (3years - renewable). The park encourages companies to graduate from the park to their own facility or to set up their own facility. So far 11 companies have graduated from park. Optiwave Photonics is the first company to graduate from the park in 2003 and are now developing products at their own facility.     The Park has had 30 companies so far of which 11 have graduated. 1. Anu's Laboratories Ltd 2. Biogenex Laboratories India Pvt. Ltd 3. Biomax Life Sciences 4. Bioserve Biotechnologies (India) Pvt. Ltd 5. IICT 6. Krebs Biochemicals & Industries Ltd 7. Medikon GalenicalsLtd 8. Nagarjuna Fertilizers & Chemicals Ltd 9. Optiwave Photonics Ltd 10. Premium Phytoceuticals 11. Albany Molecular Research Centre ]]> <![CDATA[Bangalore is top biotech city]]> https://biospectrumindia.com/news/95/1392/bangalore-is-top-biotech-city.html https://biospectrumindia.com/news/95/1392/bangalore-is-top-biotech-city.html Tue, 05 Aug 2008 10:09:00 +0530 New Page 1 Bangalore is top biotech city Biotech companies from the bioclusters in West and South generated revenues in excess of $1 billion in 2007-08. Maharashtra emerged as the leading state with $900 million in revenues, while Bangalore was the top biotech city contributing $550 million in sales during 2007-08. The biotech players in India are well spread across the country. And for the past few years, it has been observed that no single cluster has a monopoly on the revenues generated by companies headquartered in their respective regions. This trend was observed in 2007-08 too. TOP CLUSTER The biotech companies in the Western Cluster, comprising the states of Maharashtra, Gujarat and Goa, generated Rs 4,452.37 crore in revenues. The West biocluster led the market in terms of revenues generated by the companies in its region. Out of the total revenues of Rs 10,274 crore generated by the biotech companies in India in 2007-08, the West's share was 43.3 percent. It was closely followed by South at 42.2 percent. The Southern biocluster covering Andhra Pradesh, Karnataka, and Tamil Nadu was close behind West with biotech revenues of Rs 4,368.63 crore. Nine of the Top 20 biotech companies have their base in the South. The Northern cluster accounted for 14 percent share of the total biotech revenues of Rs 10,274 crore generated in 2007-08. The west region's contribution was led by Serum Institute of India, the No. 1 biotech company in the country, which accounted for over 22 percent share of the total revenues of Rs 4,452.37 crore clocked by the companies in the west. India's largest biotech group, Biocon accounted for over 25 percent share of the total contribution of Rs 4,369 crore from the Southern biocluster. TOP STATE Among the states, Maharashtra topped the contribution with 35 percent share generating Rs 3615 crore. Karnataka was second with 21.6 percent share (Rs 2220 crore) and Andhra Pradesh followed it with Rs 1,830 crore in value terms and with a 17.82 percent share. Almost three-fourths of the total biotech business in the country was contributed by the companies in these three states. TOP CITY Bangalore was the No.1 biotech city generating revenues of Rs 2,220 crore and 21.6 percent share. Mumbai was second with revenues of Rs 1,975 crore and Hyderabad was next with Rs 1,830 crore in biotech revenues. The NCR region accounted for 14 percent share (Rs 1,453 crore) and was followed by Pune with 12 percent share and revenues of Rs 1,254 crore. MAJOR PLAYERS Panacea Biotech was the largest player in the North contributing more than 46 percent of the total biotech revenues from the NCR cluster. Serum was the largest contributor to the West with 27.3 percent share While Biocon led the Karnataka regions fortunes, Nuziveedu Seeds, the country's largest bioagri company, with revenues of Rs 303 crore, was the largest contributor to the business from Andhra Pradesh with close to 17 percent share. The Top 3 companies in West accounted for 29 percent share of the region. The Top 3 companies in North generated 67 percent of the total revenues of the region. The Top 3 companies in South contributed 35 percent of the revenues of the region. The Top 3 companies in Maharashtra accounted for 35 percent share in the region. The Top 3 companies in Gujarat generated 30 percent of the total revenues in Gujarat. The Top 3 companies in Karnataka contributed 63 percent of the total revenues. The Top 3 companies' share in Andhra Pradesh was 35.46 percent.   ]]> <![CDATA[A subdued year]]> https://biospectrumindia.com/news/95/2797/a-subdued-year.html https://biospectrumindia.com/news/95/2797/a-subdued-year.html Fri, 11 Jul 2008 16:38:00 +0530 New Page 1 A subdued year The expected has happened. After five straight years of frenetic growth exceeding 30 percent, India's fledgling biotech industry has slowed down slightly in the last 12 months. The 6th BioSpectrum-ABLE Biotech Industry Survey indicates that the industry's revenue grew only by 20 percent in the fiscal year that ended on March 31, 2008. In Rupee terms, the industry collectively registered revenues of Rs 10,273 or $2.57 billion (based on the average exchange rate of 1$=INR 40) during 2007-08. The industry had recorded Rs 8,541 crore or $2.01 billion in 2006-07. Nearly two-thirds of the industry revenue comes from exports. The appreciation of Rupee against the US Dollar for most parts of the 2007-08, by 10 to 12 percent, is one of most important reason for the clipping of the biotech sector's growth rate by over 10 percent. But for the appreciation in the Dollar value, most industry leaders feel that the segment would have continued its 30 percent growth rate. The biopharma sector accounts for nearly two-thirds of the industry, and its 16 percent growth rate is the main reason for pulling down the collective industry revenues. Also, the bioagri sector which took off in 2005 and 2006 is also witnessing some slow down. The main product, the Bt cotton seed, marketed by two dozen companies, had faced tremendous pricing pressures in major markets due to government directives. The vociferous protests from anti-GM activists had forced many state governments to ask Bt cotton producers to slash the license fee drastically. However, the increasing popularity of the transgenic cotton seed variety led significant hike in cropping area. This has somewhat saved the industry and help register a 30 percent growth to clock revenues of Rs 1,200 crore. The bioagri sector will look forward to more product approvals and entry of other GM (genetically modified) products in the coming years to shore up its revenues. The star performer last year was the contract research services sector which showed 43 percent growth to overtake the bioagri segment to the No.2 slot segment-wise. In the BioSpectrum-ABLE Top 20 Club, there are some surprises. Hyderabad-based Nuziveedu Seeds has crossed Salem-based Rasi Seeds to emerge as the country's No.1 bioagri company with revenues of Rs 303 crore. Nuziveedu occupies the No.4 rank in the Top 20 biotech company list, just behind Panacea Biotec, Biocon and Serum Institute. Interestingly, Pune-based vaccine major, Serum Institute has scored a hat-trick of being the No.1 biotech company in the BioSpectrum-ABLE ranking for the third year in a year. Though No, 2, Biocon as a group has continued to perform well with its CRO arm, Syngene International firmed up a good position in the Top 20 ranking with an impressive revenue tally of Rs 160 crore. Delhi-based Jubilant group is a close second with revenues for their research services estimated at Rs 158 crore. Three biotech warhorses from Hyderabad, Shantha Biotechnics, Bharat Biotech and Indian Immunologicals have turned in super performance to boost their revenues in 2007-08. We analyzed the revenue growth of the industry in the last 5 years and it is revealing that the sector has shown a compounded annual growth rate (CAGR) of 34 percent. The BioServices showed the highest CAGR of 63 percent and bioagri sector 61 percent. Based on these growth rates, we estimate that the industry will record revenues of nearly Rs 65,000 crore by the year 2015. In dollar terms, this could be between $13 to $15 billion. Of course, the revenues could grow dramatically if regulators approve some of the innovative products currently in the pipeline. And this may help many more companies scale up their revenue potential in the next 5 to 7 years. <sureshn@cybermedia.co.in>   ]]> <![CDATA[Overview of the Top 20]]> https://biospectrumindia.com/news/95/7099/overview-of-the-top-20.html https://biospectrumindia.com/news/95/7099/overview-of-the-top-20.html Fri, 11 Jul 2008 15:51:00 +0530 New Page 1 Overview of the Top 20 ]]> <![CDATA[Rank 21-40 Companies]]> https://biospectrumindia.com/news/95/3000/rank-21-40-companies.html https://biospectrumindia.com/news/95/3000/rank-21-40-companies.html Fri, 11 Jul 2008 15:06:00 +0530 New Page 1 Nagpur-based Ankur Seeds registered a marginal growth of 5 percent in Bt cotton seeds sales for 2007-2008. The company touched a total sales revenue of Rs 75 crore in Bt cotton as against Rs 69.5 crore in 2006-2007. MG Shembekar, CEO, Ankur Seeds, said, "The financial year ending March 2008 was not very good for the seed industry as the PIL on GM testing in the Supreme Court affected the regulatory process and release of new Bt hybrids. Ankur's sales of Bt cotton were also affected as by the time new potential hybrids were released, the season in the north zone was over and central zone season was halfway." The number of packets of Bt cotton sold was more than 10 lakh plus packets priced at Rs 750 per packet, compared to last fiscal where around 9 lakh packets were sold. Last year, Ankur introduced high hybrids considering the needs of the farmers of good boll size, plant structure and good fiber characters. Major hybrids given during the year were Ankur 2226 Bt for the north zone and Akka Bt and Jai Bt for the central and south zones. All these hybrids meet the requirements of the current cotton market. Ankur Seeds will be introducing BG-II hybrids in the coming years. Though the rate of conversion to BG-II hybrids is slow owing to reduction in prices, there will be an increasing trend in the acceptance of BG II technology. The pace of acceptance will be faster in states like Punjab, Gujarat, parts of Maharashtra and Andhra Pradesh. Akka BG-II, a promising cotton hybrid, has been already launched in the central zone and will be getting approval in the south as well. The development of good hybrids is continuous process. Scientists and breeders are working over it and are fully confident of meeting future needs of the farmers. In 2009, Ankur Seeds will be having sizeable number of cotton hybrids in BG I as well as in BG II category that will cater needs of different regions of the country. In 2007-2008, Advanced Enzymes Technologies Ltd (AETL) clocked a sales of Rs 69.30 crore, registering a marginal growth of 2 percent. Within this, animal health had shown a growth while the company had incurred considerable amount of loss of revenue in its pharmaceutical business due to the ban by the Drug Controller on the use of combination drugs on textiles. Exports for AETL maintained status quo in the fiscal. CL Rathi, managing director, AETL, said, "Our export remained down last year. Before that, for two years we touched around Rs 6-8 crore from exports which was consistent. We had invested around Rs 17 crore in our SEZ factory with the hope of accelerating exports. But the plant started only in March or early April this year. So it was a loss of Rs 2 crore in exports." AETL also faced a crunch in exports due to the appreciation of the dollar with major loses in China. Also AETL could not push much to the US due to the disparity in prices. The key achievements for AETL in 2007-2008 included expansion of their R&D center. Many initiatives have been taken in the areas of food processing, pharmaceuticals, textiles labs for brewing and distilling. In 2007, AETL had spent around Rs 5.71 lakh for this set up and the investment in this facility is an ongoing process. "This year we intend to spend around Rs 8-9 crore more for our R&D," adds Rathi. Apart from R&D, AETL's core business includes marketing and manufacturing of enzymes and probiotics to different industries in India. This includes leather processing, pharmaceuticals, agriculture, animal healthcare and nutrition, textiles and tea processing. AETL recently set up a marketing office at Dacca in Bangladesh and China. The company has also identified areas in Pakistan, Nepal and Sri Lanka. Ocimum Biosolutions is an integrated life-sciences R&D enabling company providing focused solutions for different steps of the genomics process chain. After joining hands with Gene Logic, the company offers a strong bioresearch portfolio including knowledge bases in genomics and solutions in toxicogenomics, pharmacogenomics and clinical genomics. Through the BioIT division, it provides expertly trained lab information management solutions for life sciences, niche bioinformatics services and products for genomic research such as gene expression analysis, advanced statistical analysis, gene function analysis, genome annotation, sequence comparison and EST analysis. The BioMolecules division produces microarrays and oligonucleotides. The microarray Division has been acquired from MWG Biotech (Germany) and produces catalog OciChip arrays, custom OciChip arrays and offers microarray hybridization services. The oligonucleotides division, which has been acquired by Isogen Lifescience (The Netherlands), makes standard and modified DNA, RNA oligonucleotides. Ocimum delivers end to end genomic products and services out of three strategic locations worldwide, Gaithersburg MD, Indianapolis IN (United States), IJsselstien (The Netherlands) and Hyderabad (India). Ocimum, has recently launched the Genowiz 4.0, a comprehensive solution for gene expression analysis. The latest version makes the process of microarray data analysis simpler with a host of features such as AutoGuide to execute automated work flows for analyzing data, addition of organisms/genomes, automatic update of annotations, PLIER algorithm, data export in different formats, box plots and enhanced scatter plots. Ocimum aims to be the number one genomics outsourcing partner in the world. Nath Biogene undertakes seed production in Andhra Pradesh, Gujarat, Karnataka, Maharashtra, Rajasthan and Tamil Nadu. The company has elaborate seed processing facilities at Aurangabad, Coimbatore, Medchel (AP) and Munipally (AP) for ginning, delinting, processing, treating, packing and storage of seeds. The company also has processing arrangements in Gujarat, Karnataka, Madhya Pradesh and Rajasthan on custom basis. It also licenses its technology to eight companies in India. In the previous fiscal (2007-08), Nath's Bt cotton seeds under the brand name of Fusion covered around 8,00,000 acres of land (which amounts to 8,00,000 packets of Bt cotton seeds). In the previous fiscal (2007-08), its Bt cotton seeds under the brand name of Fusion covered around 8,00,000 acres of land (which amounts to 8,00,000 packets of Bt cotton seeds). It already has released four new hybrid seeds for Bt cotton -- one for the north zone, two for central zone and one for the southern zone. Nath biogene is presently working on stacked genes. It is also working on drought resistant seeds and herbicide resistant seeds. The company allots 10 percent of their revenue in R&D. For R&D, it is associated with companies in Israel and the US and four institutions in China like the Institute of Chinese of Academy of Agricultural Sciences. With an employee force of 350 personnel, Nath Biogene is presently working on stacked genes which is the incorporation of additional genes into Bt cotton. This will fight against multiple pests. It is also working on drought resistant seeds and herbicide resistant seeds. The company is also working on rice and brinjal which will cause the next gene revolution in India. For this it has tie-ups with Chinese companies This year, Nath Biogene along with its licensees and technology partners is looking at covering 2 million acres of land. For marketing, Nath is also looking at neighboring countries. The company is looking at a growth figure of 40 percent for the current fiscal. Concord Biotech is an R&D based biotechnology company having state-of-the-art fermentation facility. Acquired from DSM, a Dutch MNC, it started operations in the year 2000 with the manufacturing of Penicillin-G Amidase immobilized enzyme using its own polymer matrix. Using its expertise in the field of biotechnology and chemistry, the company is concentrating on the fermentation-based products. Concord has diversified in the field of active pharmaceutical ingredients namely Lovastatin, Pravastatin, Simvastatin and Tacrolimus. In 2005, Matrix Laboratories announced that it had acquired a controlling stake in Concord Biotech. As per the term sheet executed, Matrix would acquire 55 percent stake in Concord Biotech through a combination of purchasing of existing equity shares from the promoters and other shareholders of the company and subscribing to the new equity shares to be issued by Concord Biotech on preferential basis. Concord has provided number of technologies on biotech products to many companies in Europe and India. It has received USFDA approval for its Lovastafin facilities and striving to go for EDMF shortly. Concord is equipped with state-of-the-art facility not only for the fermentation but also for the recovery and the powder processing areas. It has the largest shake flask capacity in India, where the wild strains can be manipulated by conventional mutation programs by a team of trained scientists. Rank 21-40 Companies New Page 2 Intas Biopharmaceuticals Ltd clocked total sales revenue of Rs 50 crore with a profit of about Rs 8-10 crore for fiscal 2007â€“2008 as compared to Rs 24 crore in 2006â€“2007. Their target growth for 2008â€“09 is Rs 100 crore with profit of Rs 20 crore. Intas Biopharmaceuticals was set up in year 2000, as an independent biotechnology division of Intas Pharmaceuticals Ltd. The biotechnology division was demerged as an independent company, Intas Biopharmaceuticals Ltd, in September 2006. One of the key achievements in 2007 was the initiation of clinical trials for Neukine. The GCSF/Filgrastim trials were initiated by Intas Biopharmaceuticals in Europe last year. The manufacturing facility, based at Moraiya, near Ahmedabad, was also audited and approved by European Medicines Agency (EMEA). The company launched its product Neupeg, PEG-GCSF. The company commenced its cloning lab, which was operational in November 2007, and has already churned out two cloning molecules. There was a drastic increase in its scientific pool which is more than 100 now. Again, as far as the total employee strength is concerned, Intas Biopharmaceuticals has total employee strength of around 400. The company has acquired US-based biotechnology corporation, Biologics Process Development Incorporated (BPD Inc.), based in Poway, California, recently. Both companies are actively pursuing plans to work closely towards fulfilment of common business objectives in the area of Contract Research and Manufacturing Services (CRAMS). Intas Biopharmaceuticals has also signed a supply and distribution agreement with a Canadaâ€“based company which will market its G-CSF product (Neukine) in North America and Europe. It is a $30 million contract with a time frame of 3-4 years. For the next three years, Intas has plans to invest another Rs 300 crore, out of which Rs 200 crore would mainly be to double its manufacturing and R&D facility. JK Agri Genetics Ltd (JKAL), an erstwhile division of JK Tyre & Industries Ltd, was established in 1989 with its headquarters at Hyderabad. The division is concentrating on research and development, production, processing and marketing of hybrid seeds of sorghum, pearl millet, maize, cotton, rice, sunflower, tomato, okra and hot pepper. The company has been driven by continuous innovation in its field of activity like management, research, production, processing, quality and marketing. This has resulted in the establishment of a strong trust and brand equity of JK seeds amongst the consumers, channel members, suppliers, government officials and others. JKAL has invested extensively in biotechnology programs. It has collaborations with several national and international research institutions and agricultutal universities to harness biotechnology for crop improvement. There are many hybrids marketed by the company. But fast moving hybrids are JK 99, JK DURGA, JK 666, JK INDRA, JK Varun (555), JK Chamundi. Also in H x B we have Chamundi / JKCHB 34 / JKCHB 229. The company has developed a range of superior hybrids with Bt gene and other novel genes that will fulfil farmer's aspirations. A team of 15 committed scientists are currently working on the application of DNA markers such as RFLP, AFLP, SSR and ISSR, agrobacterium and biolistic mediated transformation technology in various crops using novel genes and application of in vitro culture of regeneration of transformed plants. JKAL has a 'participatory plant breeding process' in which the customers and channel members interact with breeders and help in the setting up the breeding objectives and also select the hybrids best suited to their environs on parameters like performance, quality of produce, pest tolerance and end uses. Some of its hybrids of grain sorghum, pearl millet and maize have been recommended for release by national apex agricultural research body - ICAR and further notified by Government of India for cultivation in India in different agro-climatic zones. JKAL is planning to diversify into research on medicinal and aromatic plants with core activities including cultivation, contract farming, varietal development, quality extract production and chemical and DNA fingerprinting. Krishidhan Seeds Ltd (KSL) clocked a total turnover of Rs 185 crore registering a 50 percent growth in revenue compared to 2006-2007, out of which the biotech revenues were close to Rs 40 crore. The year saw an investment of Rs 5 crore in the company's R&D department. The development strengthened with an additional building for biotechnology and recruitment of 44 eminent scientists/breeders from public and private sectors. The year also saw tie-ups and collaborations with more than a dozen national and international institutions for biotech research and product development in major field and vegetable crops with 6 crop specific farms developed with modern facility. A sum of Rs 2.5 crore was invested on processing seed packaging through fully automated plants for cotton and vegetable seeds. Several products were introduced in different zones as well as listed in regulatory trial which got permission for commercialization in 2008. The north zone saw the approval of 9810 (BGI) and 441 (BGII). The central zone saw 9810, 9821, 786 (BGI) and 621 (BGII), 9632 (BGII) and lastly the southern zone saw 9810, 407 BGI) and 621 (BGII) getting approved. Having a workforce of 900 people, KSL also entered into tie-ups and partnerships with Gujarat State Seeds Company Ltd (GSSCL), which has been given exclusive rights to market company's Bt cotton in Gujarat. Rank 21-40 Companies New Page 3 Indovax is engaged in the production of quality poultry biologicals since 1991. The company's turnover in the year 2007-08 was just over Rs 35 crore as compared to Rs 30 crore in 2006-2007. Its product portfolio consists of viral vaccines, inactivated vaccines and bacterins. Some of them are Newcastle vaccine (Ranikhet vaccine), Gumboro vaccine (IBD), Marek's vccine, infectious bronchitis vaccine, fowl pox vaccine, fowl cholera vaccine and infectious coryza vaccine. It has a modern state-of-the-art facility spread over 14 acres in a completely poultry-free zone. According to Deepak Kapur, "The year 2008-09 will start to see new products from Indovax. Our R&D pipeline is now filling up and the industry will benefit with the release of these innovative. Our objective is to introduce a new product every six months." The total revenue of Dr Reddy's Laboratories has grown to Rs 50 billion ($1,250 million) in FY08 as against Rs 65 billion ($1,627 million) in FY07. The revenues in India for finished dosage have crossed $200 million in FY08. Revenues in India increased by 16 percent to Rs 8.1 billion in FY08 from Rs 7 billion in FY07. Growth was primarily driven by key brands of Omez, Razo, Stamlo Beta and Reditux. Revenues from Reditux launched in April 2007 fetched in Rs 154 million in FY08. Twenty new products were launched during the year, contributing Rs 309 million in revenues. Dr Reddy's is currently dedicated to the development of biosimilars, while its long term vision is to also develop New Biological Entities (NBEs) in niche therapeutic areas Hester Biosciences (formerly Hester Pharmaceuticals) is a GMP and ISO 9001:2000 certified company, manufacturing poultry vaccines. Located near Ahmedabad in Gujarat, Hester has a state-of-the-art facility to produce live and killed (inactivated) veterinary vaccines. Through its seromonitoring services, Hester helps producers evaluate the immune response to administered vaccines and/or to obtain evidence of flock exposure to field strains. The turnover of Hester Biosciences is Rs 32.24 crore for 2007-2008 as compared to Rs 21.83 crore in 2006-2007. The company registered a growth of 37 percent in net profit and 92 percent in cash profit on a 50 percent growth in sales over last year. The company has recommended a 25 percent dividend for the year 2007-2008. Nicholas Piramal India Ltd (NPIL), which was ranked fourth by ORG IMS(2007) is now looking at making its presence felt in the biotech space. It generated sales of Rs 22.42 crore from marketing of biotech products in therapeutic segment in 2007-2008. In 2008 it was announced that subject to shareholders' and Central government's approval, NPIL will be known as Piramal Healthcare Ltd, while the group companies NPIL Laboratories and Diagnostics will be known as Piramal Diagnostic Services. NPIL Research & Development was recently renamed Piramal Life Sciences Ltd (PLSL). PLSL has a number of molecules in its research pipeline. It also has a comprehensive library of plant extracts and microbial strains. NPIL signed a second drug development agreement with Eli Lilly whereby both parties will carry out independent clinical trials on a certain candidate. ABL Biotechnologies Ltd (ABL), based in Chennai is a pioneer in harnessing the biodiversity of the Indian marine environment. The company generated sales of Rs 20.03 crore in 2007-08. ABL has been working on identification and commercial extraction of biochemicals, predominantly from microbes, that have far reaching applications as nutritional, cosmetic, pharmaceutical and industrial intermediates. ABL has been conducting research on polysaccharides, essential fatty acids, natural pigments, tracers and tags with considerable success. Its present focus includes work on pharmaceuticals like anti-bacterials and anti-virals, enzymes, bio-molecular materials, bio-monitors and diagnostics, bio-pesticides, bioremediation and aquaculture. The company has recently received two of its projects supported under the SBIRI scheme. Zytex (India), engaged in marketing of a broad range of biotechnological products, has increased its sales turnover to Rs 20 crore in 2007-08 from previous year's sales of Rs 15 crore. Zytex offers products such as probiotics, enzymes for baking, food, animal feed, nutraceuticals, fructo-oligo saccharideand textile garments processing chemicals. Zytex has a world-class R&D research lab and application support lab, which is approved by the Department of Science and Industrial Research (DSIR). In 2007, the company made a strategic technical collaboration with Giovanni Bozzetto, Italy, the leading European textile auxiliaries' manufacturer since 1919. Zytex research is based on fermentation technology and with prime focus on nutraceuticals and cosmoceuticals. The company has also established a new manufacturing facility at Savli Biotech Park, Baroda. Strand Life Sciences is a premier in silico technologies innovation company focused on developing technologies for drug discovery and development. Strand leverages its core strengths in data mining, predictive modeling, computational chemistry, software engineering and research biology to develop technologies and offer various products for research biology, chemistry and drug discovery. Strand also offers custom solutions based on its technologies. Strand has three streams of business spanning early target discovery through pre-clinical development. Strand's software products are built on the award winning avadis platform technology. Over 500 users worldwide use these products and several significant publications reference the avadisTM-based products. Note: Zytex and Strand Life Sciences share the 35th Rank. Rank 21-40 Companies New Page 4 Hyderabad-based Celestial Labs has been providing customized IT solutions for pharma, biopharma, biotech and manufacturing and sale of biological products like enzymes, nutraceuticals. The company's revenue from its products and services for the year 2007-08 stood at Rs 19.91. Celestial labs have been offering a comprehensive range of products and services on a long-term basis, across the world. Celestial Labs is setting up a biotechnology facility in Genome Valley at Hyderabad to manufacture its own drug molecules, industrial enzymes and to contract research activities. The business plan of Celestial Labs is essentially based on the production and supply of the biotechnological products which have very significant industrial implications, especially in both pharma and biopharmaceutical sectors.   Varda Biotech offers integrated services in biotechnology and pharmaceuticals. It has introduced educational biotechnology kits for schools, colleges, universities and educational institutes, under the brand name Bio-knowledge Kit, which help perform basic techniques in molecular biology and immunology with minimum available equipments, even in a remote facility. It also offers a list of enzymes such as an ultra pure and highly thermostable recombinant Taq DNa polymerase, Hotstrat Taq and Klintaq. The list of industrial enzymes includes cellulase, xylanese, serratiopeptidase, co-enzyme Q-10 and poultry enzymes such as phytase. The company also has strategic alliances for product association and representations, in various parts of the world like the US, Europe, Latin America, Middle East and Asia.   In 2007-2008, Bangalore-based Multiplex Biotech clocked revenues of Rs 15 crore through sales from its biotech products, registering 61 percent growth in its biotech revenues compared to that in 2006-07. Multiplex Group was established in 1974 by Dr GP Shetty, an eminent plant physiologist with years of experience. Multiplex Group is focused on research and development of bioagri products that help the farmers to increase their crop productivity by harnessing the fertility of the soil. Multiplex has state of the art R&D facility and a team, comprising of several scientists, that is continuously striving towards improvising and innovating newer products. The company offers all types of micronutrient products, seeds, bio activators, bio pesticides, formulation of pesticides to name a few.   Zenotech increased its biotechnology turnover to Rs 10.41 crore in 2007-08. The company develops new biological entities in the areas of cancer and neurology. The company has initiated target identification and validation programs using gene and protein based technologies. Zenotech utilizes validated targets for generating new therapeutic entites. The company plans to adopt a comprehensive approach to therapeutic monoclonal antibody generation by bringing together skills in the areas of recombinant DNA technology, protein purification and characterization in the development of new antigen and antibody-based therapeutics for clinical studies. Zenotech also develops and manufactures generic biopharmaceuticals and markets them to people with unmet medical needs around the world.   Excel Industries manufactures quality chemicals relevant to the needs of industry and agriculture. It has three business divisionsâ€“agri, chemical and environment and biotech. The environment and biotech division has developed biodynamic products and processes to manage municipal solid waste, putrescible wastes from the agriculture, horticulture and aquaculture industries, sewage sludges, industrial waste streams and contamination of soils and waters by hydrocarbons and other organic compounds. This division has two product categories - agricultural biotech products and environment biotech products. The agricultural biotech products make extensive use of naturally occurring microbes such as bacteria and fungi. The products are classified under the categories of soil enrichers and biopesticides. ]]> <![CDATA[GSK Pharmaceuticals]]> https://biospectrumindia.com/news/95/5786/gsk-pharmaceuticals.html https://biospectrumindia.com/news/95/5786/gsk-pharmaceuticals.html Fri, 11 Jul 2008 15:05:00 +0530 New Page 1 Rank 20 GSK Pharmaceuticals The great Indian dream GSK has consolidated its position in India by strengthening its position in the vaccine market. It has already made India a hotbed for its operations. GlaxoSmithKline Pharmaceuticals (GSK) recorded a total biotech sales of Rs 80.40 crore against last year's sales of Rs 79 crore. The growth in sales for the company's continuing business, after excluding the financials of the agrivet farm care and the Qualigens Fine Chemicals business, which has been sold, was 14 percent. Profits before tax and exceptional items grew by 25 percent on a comparable basis. For the full year, sales of the continuing business have grown by 7.8 percent and profits before tax and exceptional items grew by 13.8 percent. GlaxoSmithKline in India is an affiliate of GlaxoSmithKline Biologicals, one of the world's leading vaccine manufacturers, headquartered in Rixensart, Belgium. In India, the division leads the represented vaccine market with a 51 percent market share. India today is a hot spot for GSK Biologicals. GSK Biologicals, will make India a global hub for clinical research and development. It is going to conduct clinical R&D process in India for its hi-tech vaccines for AIDS, dengue, malaria and TB. The company is now planning to conduct trials in India for nearly every product in the global research pipeline. It has already identified 6 centers for oncology to conduct early phase trials in India. Fiscal 2007-08 saw a couple of product launches by the company. Till date vaccines has been a key growth area for GSK in the Indian market. As of now GSK markets 12 types of vaccines in the Indian market. Some of the top brands include Engerix B, Varilrix, Havrix. Vaccines registered a growth of 24 percent with sales clocking at $165 million. In January 2008, it announced the launch of two new innovative Diphtheria, Tetanus and acellular Pertussis (DTP) vaccines-- Boostrix and Infanrix. GSK's Boostrix is USFDA approved and well accepted in 58 countries. American Academy of Pediatrics (AAP) recommends Boostrix at 10 years of age. Commenting on the launch of the two vaccines, Dr Hasit Joshipura, managing director, GlaxoSmithKline Pharmaceuticals, said, "GSK India remains committed to providing the latest and most effective preventive care particularly for children. The launch of Infanrix and Boostrix will be a step forward in this mission." In 2007, GSK forayed into the cardio-vascular segment with the launch of its product Carzec (carvedilol), a beta-blocker indicated in patients with heart failure and for the management of hypertension. GSK India which has also been focusing on its pharmaceutical business also had some significant launches in this segment during this fiscal. Some of the launches included were Inflapen, Arixtra, and Zemetril. GSK has two manufacturing units in India, located at Nashik and Thane, as well as a clinical development center in Bangalore. The state-of-the-art plant at Nashik makes formulations while bulk drugs are manufactured at Thane. GSK has a target of achieving a growth target of 20 percent in biopharmaceuticals by 2015.   ]]> <![CDATA[Haffkine Bio-Pharmaceutical Corporation]]> https://biospectrumindia.com/news/95/5582/haffkine-bio-pharmaceutical-corporation.html https://biospectrumindia.com/news/95/5582/haffkine-bio-pharmaceutical-corporation.html Fri, 11 Jul 2008 15:00:00 +0530 New Page 1 Rank 18 Haffkine Bio-Pharmaceutical Corporation Oral polio vaccine pioneer Haffkine Bio-Pharmaceutical Corporation is credited for developing the first indigenous oral polio vaccine (OPV). Haffkine Bio-Pharmaceutical Corporation, a fully owned company of the Maharashtra government, is involved in the development and production of a wide range of bacterial and viral vaccines for diphtheria, tetanus, whooping cough, plague, poliomyelitis and rabies. This is one of the few companies which has been successful in the public sector. It is credited for developing the first indigenous oral polio vaccine (OPV). Today the corporation is in a sound position as result of strategic planning and sustained efforts resulting in appreciable increase in productivity levels and cost reduction. With continued zeal and confidence of its 600 plus employees and support from the Central government as well as the Maharashtra government, Haffkine has been increasing its profits since 1997-98. Haffkine has a strong historical background. Dr Waldemar Mordecai Haffkine, the man behind Haffkine, was a Russian and an illustrious disciple of Dr Aleck Metchnikoff and Dr Louis Pasteur. Dr Haffkine came down to Calcutta in 1892 with a mission to tackle the problem of a cholera epidemic. He arranged for clinical trials of his vaccine and successfully helped to combat the dreadful disease from spreading further. It was in 1896 when plague broke out in Mumbai, he was invited to set up a Plague Research Laboratory in the city. The plague vaccine introduced by Dr Haffkine proved to be so effective that it was said that he single handedly conquered the 'Black Death.' Since then the institution he founded has gone from strength to strength with Dr Haffkine continuing to provide the inspiration. The Plague Research Laboratory was later renamed Haffkine Institute in 1925. In order to expand the production activities and to meet the growing demand for medicines and life saving drugs, Haffkine Institute was bifurcated by the state government in 1975 and the production activities were entrusted to Haffkine Bio-Pharmaceutical Corporation. Haffkine also established a subsidiary company in 1977, viz. Haffkine Ajintha Pharmaceuticals at Jalgaon, in collaboration with Western Maharashtra Development Corporation. This subsidiary company produces tablets, capsules, powders and ointments. The subsidiary also has its manufacturing plant with modern facilities, located at Jalgaon and is engaged in the manufacture of tablets, capsules, ointments, powders and liquids, which are mainly supplied to hospitals/government institutions. In 2002 it obtained WHO-GMP certification for production facility at Pimpri near Pune. Here antitoxins and sera for snake and scorpion venom, tetanus and diphtheria toxins are produced. It also formulates pharmaceutical products, disinfectants, ointments, injectables, syrups and mixtures at its unit at Mumbai. The company has a well-equipped animal house in Mumbai for breeding laboratory animals.   ]]> <![CDATA[Bharat Biotech]]> https://biospectrumindia.com/news/95/1254/bharat-biotech.html https://biospectrumindia.com/news/95/1254/bharat-biotech.html Fri, 11 Jul 2008 14:51:00 +0530 New Page 1 Rank 15 Bharat Biotech Innovative R&D Bharat Biotech has many products in the stage of clinical trials like malaria vaccine candidates, PvrII, rotavirus vaccine candidates, chikungunya vaccine and pandemic influenza vaccine. Bharat Biotech International Ltd (BBIL) has achieved an annual turnover of Rs 126 crore and the company is expecting to touch Rs 300 crore in the year ahead. Established in the year 1996 by Dr Krishna M Ella and Suchitra K Ella, Bharat Biotech is engaged in developing next-generation vaccines and biotherapeutics through innovative and collaborative research. It recently announced the encouraging results from a recent Phase I/II clinical trial of a live, natural reassortant, oral rotavirus vaccine 116E (ORV 116E), conducted in New Delhi, India. Bharat Biotech has set new benchmarks in innovation and quality that epitomizes the tremendous progress of Indian biotechnology in the global arena. "We invest almost Rs 30-35 crore in a year in R&D. For the malaria vaccine and rotavirus program, we are supposed to be investing almost Rs 25 crore," said Dr Krishna M Ella, managing director, BBIL. Bharat Biotech augmented the development of vaccines in the mid 1990s. The discovery and development of Revac-B, the world's first cesium chloride free recombinant hepatitis-B vaccine in 1998, offered Bharat Biotech's young business the opportunity to foster significant revenue potential in an area of high unmet need. The brand found instant acceptance in the country and is today one of the leading brands in its product category. Bharat Biotech advanced its expertise further with the development of its second key product Biogit, India's first indigenously manufactured probiotic yeast. Biogit scored over other probiotics and existing Lactobacillus products with its own set of unique strengths. Bharat Biotech launched its second key vaccine - Typbar, a new generation typhoid vaccine in 2003 and then added another first to its growing list by introducing Zelect â€“ Zinc with oral rehydration salts based on WHO approved formula. All these products experienced rapid uptake among the medical community and opened a new era of financial stability for Bharat Biotech. The company became the first to develop and launch Indikinase in 2003-India's first recombinant streptokinase, the firstline therapy for myocardial infarction. Indikinase is poised to offer substantial market expansion opportunities for the mature recombinant streptokinase brand. In 2005, Bharat Biotech became the country's first biotechnology company to launch recombinant human Epidermal Growth Factor (rhEGF)-Regen-D. The company introduced Regen-D in two strengths; Regen-D 150 for diabetic foot ulcers and Regen-D 60 for I & II degree burns and conditions arising from donor site skin grafts. Bharat Biotech has many products currently in the stage of clinical trials like malaria vaccine candidates, PvrII, rotavirus vaccine candidates, ORV116E, combination vaccine (Hepatitis-B+DPT+Hib), bioantibiotics, combination probiotics, chikungunya vaccine and pandemic influenza vaccine.   ]]> <![CDATA[Eli Lilly]]> https://biospectrumindia.com/news/95/1041/eli-lilly.html https://biospectrumindia.com/news/95/1041/eli-lilly.html Fri, 11 Jul 2008 14:48:00 +0530 New Page 1 Rank 14 Eli Lilly Formidable presence Eli Lilly launched Byetta, a new class of drug for Type B diabetics and has plans to launch new products in the coming years. Eli Lilly and Company (India) is a 100 percent subsidiary of the US pharmaceutical major, Eli Lilly and Company. The company first came to India in 1993 as a JV with Ranbaxy. It became a wholly owned subsidiary in 2001 when Lilly bought the 50 percent stake held by Ranbaxy and since then the company has established a formidable presence in cardiology, diabetes and oncology amongst other therapeutic segments. Lilly India has five products from the biotechnology stable. All injectibles, they are human insulin (including human insulin analogs), human growth hormone, Teriparatide (Forteo), Drotrecogin Alfa (Xigris) and Exenatide (Byetta). Overall, diabetes care product range contributes roughly 60 percent of the Lilly India revenue. In the biotech category, the company grew an impressive 20 percent in 2007 clocking revenue of Rs 137 crore compared to Rs 114 crore in 2006. The company's recent product launches include Byetta that was introduced in October 2007. The drug belongs to a new category called "incretin mimetics" and is a unique treatment option for Type 2 diabetics, more specifically for patients who have maxed out on the OHA's (oral hypoglycemic agents). According to Sandeep Gupta, CMD, Lilly, "Byetta is a first-in-class product. These are early days, however within 3-4 months from its launch, nearly 1000 patients have been put on the therapy across India." Forteo, Lilly's novel therapy that 'rebuilds' bones and is used for treating women with osteoporosis, registered a whopping growth of almost 100 percent in 2007 as compared to the previous year. Lilly India recently tied up with an Ahmedabad-based Contract Sales Organization (CSO), PharmaLink, to further enhance its reach in large towns while maintaining adequate coverage in smaller markets. The company also divested its premium antibiotic brand, Distaclor. This was done with a view to augment company focus on its range of new products. Also in a global deal, the company entered into a unique drug development agreement with Mumbai-based Nicholas Piramal India Ltd (NPIL) in 2007. Under this partnership, Lilly has outlicensed a molecule for 'metabolic disorder' to NPIL with an arrangement to do research till phase III and if the product is found to show the desired potential, Lilly has the "call-back" option after making a payment to Nicholas for the same. On the CSR front, the company recently announced an additional $15 million to the "Lilly-MDR-TB Partnership" making the company's global financial commitment to this partnership reach an astounding $135 million. The partnership was first announced in 2003 to confront multi drug-resistant tuberculosis and has mobilized 18 global partners on five continents till now. Commenting on Lilly India's future plans, Gupta said, "We plan to launch 5-6 new products over the next four-five years. We would look at products in the area of diabetes care and oncology and would be open to exploring other therapeutic areas as well. Ultimately, it would depend on what products come through the Lilly pipeline that has relevance to the affiliate strategy." ]]> <![CDATA[Jubilant]]> https://biospectrumindia.com/news/95/6600/jubilant.html https://biospectrumindia.com/news/95/6600/jubilant.html Fri, 11 Jul 2008 14:38:00 +0530 New Page 1 Rank 11 Jubilant On an acquisition spree With three acquisitions over the past year and new contracts in the fray Jubilant Organosys is going great guns. Jubilant Organosys, an integrated pharmaceutical industry player, is one of the largest custom research and manufacturing services (CRAMS) and drug discovery and development services companies out of India. The company has a presence across the pharmaceutical value chain for products and services such as exclusive synthesis, contract manufacturing, proprietary products, active pharmaceutical ingredients (APIs), generic dosage forms, drug discovery services, drug development services, chemistry services, clinical research services, steriles (injectables including lyophilized products, creams and liquids), non-steriles (tablets, lotions, ointments) and radiopharmaceuticals. The company's drug discovery and development business in 2007-08 was estimated to be about Rs 159 crore. In June 2007, Jubilant announced the largest overseas acquisition in contract manufacturing by an Indian company, through its purchase of Hollister-Stier Laboratories (Hollister). Contract manufacturing of sterile injectables at Hollister has strengthened Jubilant's pharmaceuticals and life science products segment. In December 2007, Jubilant entered into a collaboration agreement with US-based Forest Laboratories Holdings to discover small molecule drug candidates for a novel metabolic disorders target. Jubilant Biosys will conduct the drug discovery work and Forest will have responsibility for the subsequent pre-clinical and clinical development. Under the terms of the collaboration, Forest will pay Jubilant undisclosed amounts towards research funding, development and commercialization milestones. In May this year, Jubilant also acquired Speciality Molecules, a niche manufacturer of specialty intermediates with manufacturing facilities located in Ambarnath (near Mumbai) in India. The company had also announced new contracts worth $92 million for its proprietary products and exclusive synthesis segment under CRAMS business for the present calendar year (CY 2008). The increase in size is 50 percent as compared to last year. The new contracts have been signed with prominent international pharma and other life science companies. Only recently the company completed the transaction effective May 28 to acquire Canada-based Draxis Speciality Pharmaceuticals (Draxis) for approximately US$ 255 million. "Jubilant has performed exceptionally well" -Shyam Bhartia, CMD, Jubilant Jubilant has performed exceptionally well in 2007-08 with our pharma and life science products and services businesses segment contributing over 61.5 percent of our revenue annually. Our focus has been in optimizing our servicing capability in CRAMS and drug discovery and development services. Jubilant continues its thrust in life science business with special emphasis on outsourcing, focused on CRAMS, DDDS and international business.   ]]> <![CDATA[Syngene International]]> https://biospectrumindia.com/news/95/2625/syngene-international.html https://biospectrumindia.com/news/95/2625/syngene-international.html Fri, 11 Jul 2008 14:34:00 +0530 New Page 1 Rank 10 Syngene International Customized services From early stage discovery and process development through to cGMP manufacturing, Syngene provides customized R&D services to pharmaceutical and biotechnology companies on a strong platform of confidentiality and intellectual property protection. Syngene International (Syngene), a subsidiary of the biopharma major, Biocon is an internationally reputed custom research company with multi-disciplinary skills in synthetic chemistry and molecular biology. The company clocked revenues of Rs 160 crore in 2007-2008. It conducts high value R&D in early stage drug discovery and development for a diverse global clientele. From early stage discovery and process development through to cGMP manufacturing, Syngene provides customized R&D services to pharmaceutical and biotechnology companies on a strong platform of confidentiality and intellectual property protection. Established in 1994, Syngene was India's first custom research organization to receive special export status by the Government of India. "We are among India's foremost integrated custom research service providers. Our considerable scientific talent pool and state-of-the-art R&D and production facilities enable us to enhance productivity and accelerate delivery of all projects with the highest degree of professionalism. Proprietary technologies and superior knowledge-driven concepts propel our reputation as a 'full-service research hub'. Leveraging India's powerful value advantage while continuing to deliver high levels of innovation, we remain compelling collaborators for advanced, cost-effective custom research services," said Goutam Das, COO, Syngene. Biocon plans to list Syngene International in the next two years, post demerger. "The listing will not be immediate but over a period of time in the next two years. The company has to grow first. We are yet to take a call on this. Post the listing in India, we might look at an overseas listing," informed Dr Kiran Mazumdar Shaw, CMD, Biocon. The company has developed skills in synthetic chemistry and molecular biology, process chemistry and cell line services. The company is also leveraging the convergence of IT and biotech. In early 2007, the company entered into a research partnership with Bristol-Myers Squibb (BMS). Through this partnership, the company is to provide R&D services for discovery and early drug development to BMS. Under the terms of the agreement, Syngene partners with BMS through a dedicated research facility at Biocon Park in Bangalore. The facility is to house 400 scientists to help advance BMS' discovery and early drug development and also significantly increase the scope of its existing relationship with Syngene to further develop integrated capabilities in India. Dr Kiran Mazumdar-Shaw added, "Our research services business have grown by 29 percent to Rs176 crore from Rs136 crore and this of course contributes to about 16 percent of our overall revenues. Albeit at a profit level, I think we have seen this take a little bit of a hit in terms of Syngene's profitability. This is largely because of the impact of the depreciation in the US Dollar and the expenses that we have had to incur for ramping up our Syngene capabilities in anticipation of some big contracts that we have seen coming in, especially the BMS contract".   ]]> <![CDATA[Novozymes South Asia]]> https://biospectrumindia.com/news/95/2844/novozymes-south-asia.html https://biospectrumindia.com/news/95/2844/novozymes-south-asia.html Fri, 11 Jul 2008 14:17:00 +0530 New Page 1 Rank 7 Novozymes South Asia Catalyzing success Novozymes acquired Biocon's enzyme business for an agreed purchase price equivalent to DKK 551 million. With this acquisition, Novozymes aims to strengthen its position in India. With the acquisition of Biocon's enzyme business, 2007-2008 proved to be a good year for Novozymes with high sales of Rs 225 crore. The company presently holds close to 65 percent share in the industrial enzymes market and plans to take this figure to 70 percent in the year ahead. In textiles it holds a 90 percent share followed by a number of formulators in the country and in starch again it has a 90 percent share. Headquartered in Denmark, Novozymes is a group company of Novo Nordisk. In India, the company is represented by Novozymes South Asia, located in Bangalore. Through its wide network of sales and marketing professionals, Novozymes South Asia is exploring the Indian market for the product range offered by the company. Novozymes last year acquired the Biocon's enzyme business for an agreed purchase price equivalent to DKK 551 million ($115m or â‚¬83.4m). With this acquisition Novozymes aims to strengthen its position in India. Commenting on the acquisition, GS Krishnan said, "After the acquisition we have become very much visible now. It has given us a leadership position in the market. Even before the acquisition we were in a leadership position, but now after the acquisition, we hold more than 65 percent of the market share. However, we are looking at a target of 70 percent." Novozymes is building up new laboratory, repacking and office facilities in Bangalore which are expected to be ready in another one and a half years' time. Thereby, Novozymes establishes R&D operations in India in a big way for the first time. The R&D unit in India will initially focus on optimizing enzyme properties, and application development. Novozymes spends about 13 percent of its turnover on R&D. And around one tenth of its expenditure on R&D is used in new areas, in line with its strategy of building up new business areas beyond enzymes and microorganisms. By 2010 the company aims to produce second-generation bioethanol that converts waste and agricultural residues into energy. This will be a radical development in the search for new renewable energy sources. Sharing the company's future plans, GS Krishnan said, "We will be looking more into the Indian enzyme market, specific local applications, specific products to the Indian market and also get into some of the areas which are still going slow. Our long term plan is to get closer to some of the research institutes in developing certain applications relevant to the local market. We are watching biofuels and biodiesel areas very closely to see how we can contribute through our experience and our expertise. We want to bring Novozymes India on the map of Denmark." ]]> <![CDATA[Panacea Biotec]]> https://biospectrumindia.com/news/95/1497/panacea-biotec.html https://biospectrumindia.com/news/95/1497/panacea-biotec.html Fri, 11 Jul 2008 13:58:00 +0530 New Page 1 Rank 3 Panacea Biotec Powering immunization Panacea Biotec forayed into oncology with seven products at the same time championing the cause of global immunization along with a drug discovery pact with Punjab University. Panacea Biotech registered net turnover of Rs 830.44 crore during 2007-08 as compared to Rs 831.55 crore for the previous financial year. The formulations turnover grew by 17.6 percent at Rs 152.10 crore during the financial year 2007-08 against Rs 129.64 crore during the previous financial year. Income from vaccine business was better by $10 million due to marginal improvement in demand of the vaccines. The total biotech turnover (including vaccines) was Rs 677. 9 crore during the financial year 2007-08 as compared to Rs 701.13 crore during the previous financial year. The PBT for the financial year 2007-08 was Rs 190.47 crore as compared to Rs 209.1 crore during previous financial year. The company filed 143 patent applications internationally this year, taking the tally to 828 patent applications so far. The company currently is a market leader in the private Indian combination vaccine market, with a 45 percent market share. The formulations segment of the company registered 18 percent growth in 07-08 which is higher than industry growth of 14 percent as per ORG IMS. The previous year also saw Panacea Biotec foray into oncology segment to provide treatment for breast cancer, brain tumor, ovarian cancer, pancreatic cancer, prostrate cancer and colorectal cancer with its seven anti- cancer products. The drugs were manufactured by a Mumbai-based company and sold under the brand name of Panacea Biotec. A new strategic business unit SBU, Oncotrust with a strength of 50 sales specialists on oncology was set up to market the drugs with an aim to register sales volumes of Rs15-20 crore in oncology chemotherapy segment in the next three years. Panacea Biotec has been playing an imperative role in immunization through its novel and innovative, world's first fully liquid vaccine with brands such as, Easy Four and Easy Five, for over three years. It has partnered with the WHO and UNICEF with a mission of supporting the cause of maximizing coverage of vaccines under the Expanded Program on Immunization (EPI) for more than a decade. In continuation to the same, it entered into a Memorandum of Agreement (MoA) with Family Vaccines, Philippines last year to provide access to value added combination vaccines under the umbrella of Easy Vaccines manufactured by Panacea Biotec, to the people in Philippines through a chain of 50 immunization clinics, run by Family Vaccines. The company also inaugurated its ultra modern, Greenfield construction, vaccine production plant at Baddi, Himachal Pradesh with over Rs 100 crore (approximately $25 million) investment in September 2007, having capacity of more than one billion doses per annum, to cater to domestic and global markets. In January 2008, the company received pre-qualification by WHO for two of its innovative combination vaccine for pediatric immunization â€“ Ecovac-4 (DTP+ Hep.B) and Easy Four (DTP+ Hib). Panacea Biotec is already a pre-qualified supplier of OPV and Hepatitis-B vaccines to UN agencies. The combined demand for all combination vaccines globally is estimated at $600 million and is expected to grow up to $1.6 billion by 2012. The company also entered into a Memorandum of Understanding (MoU) with Punjab University, Chandigarh, for a drug discovery project. Under the MoU, Drug Discovery Research, an SBU of Panacea Biotec located at Mohali (Punjab) and Punjab University will collaborate to identify a lead molecule with an aim to bring a drug superior to existing marketed products in the therapeutic area of psychiatric disorders. As per the agreement, the university would transfer chemical and biological information on molecules to Panacea Biotec to develop as drugs. In recognition of the company's achievements, the joint managing director, Rajesh Jain was ranked 40th in the list of 40 global, most influential persons to determine the course of pharmaceutical industry by World Pharmaceutical Frontiers and published in SPG Media, London. Looking forward, the company feels that it would be able to launch novel drug delivery based anti-cancer drug in the next 2-3 years. "We plan to develop novel and innovative drug delivery systems (NDDS) of the existing anti-cancer molecule. The new research based drug development will take 2-3 years as we need to develop an effective distribution chain and occupy a significant market share in oncology drugs," Jain said. "We aim to up the ante on innovation" -Rajesh Jain, joint managing director, Panacea Biotec What are the different products that Panacea has introduced? Many new brand extensions in the Diacar SBU were launched, which offer a better therapeutic profile to doctors to manage the relevant disease more effectively. An innovative Inactivated Polio Vaccine (IPV), Polprotec, has been launched in June 2008. Another novel vaccine, Novohib (Hemophillus Influenza Conjugate), is expected to be launched in this quarter (July-September 2008).   What were the challenges in the last fiscal? Rupee's appreciation against the US Dollar was the greatest challenge. The company minimized the impact of this challenge through a mix strategy by hedging, price revision and volume growth. Also, competition in pharma and vaccines market in India due to generic players through value added products and marketing strategies was another challenge. With India being a price-sensitive market, one needs to balance affordability with the cost of marketing and R&D and I think we have been reasonably successful in doing so.   What has been the R&D spend in the last one year? It has been close to Rs 54 crore for 2007-08. Our fifth, state-of-the-art, world class R&D center -- Global Research & Development (GRAND) at Navi Mumbai was inaugurated in February this year. GRAND has been set up with a vision to be a global leader in the delivery of conventional and biotech-based drugs for unmet therapeutic needs of safety, efficacy and compliance involving world class science. The research at GRAND will be an intersection of biological, clinical, pharmaceutical sciences and engineering/design to develop Novel Drug Delivery Systems (NDDS) based products leading to generation of intellectual property and know-how. Built on truly international standards, GRAND will reflect Panacea Biotec's leadership in R&D in the field of cancer, GI, CNS and CVS diseases.   How has Oncotrust fared since its launch last year? Oncotrust is fairly on course. We started with five products and then added one more product to our oncology basket. Despite a few initial hiccups, we have had a reasonable market share. Market for oncology products is highly competitive, yet we have been able to garner sales of around Rs 50 lakh every month. Our target is to achieve a sales of around Rs 12 crore by the financial yearend.   What is the future strategy of the company? We are looking at consolidating on our anti-cancer segment in the next few years. I think we shall be looking at nurturing new opportunities at the same time consolidating our position in the existing segments. Going forward, the key strategy will be to maximize the shareholders wealth by increasing the company's top and bottom line through successful implementation of key projects within stipulated times.   You have recently been ranked one among the influential people to determine the course of the Indian pharma industry. How do you see the way forward for the Indian biotech industry? India has for long been a cost effective hub, be it for software, pharma, telecom or automobiles. But with the rising per capita income, there is going to be an increase in the per capita expenditure as well. Thus, innovation is going to be the key for every industry including the biotech industry. Panacea Biotec as a company has its foundation in a symbiotic and synergistic interaction of several small units within the company, which is a unique business model. We aim to up the ante on innovation as we continue to grow in size. ]]> <![CDATA[Biocon]]> https://biospectrumindia.com/news/95/2691/biocon.html https://biospectrumindia.com/news/95/2691/biocon.html Fri, 11 Jul 2008 13:54:00 +0530 New Page 1 Rank 2 Biocon Strategic moves Biocon has increased its capital expenditure to support business expansion. The company has a strong balance sheet, which it plans to use for strategic acquisitions and investments. The total revenues of Biocon, one of India's premier biotechnology companies, for fiscal 2007-08 increased 19 percent to Rs l,090 crore, up from Rs 990 crore in the previous year, and net profit increased by 3 percent to Rs 225 crore. The consolidated revenue (excluding enzymes) increased by 19 percent from Rs 881 to Rs 1,044 crore this fiscal. Impressive growth in research services helped Biocon post a fourth quarter profit of Rs 62.03 crore, a growth of 31.16 percent from Rs 47.29 crore in the same quarter last year. The company's net sales in the quarter that ended March 31, however, declined 5.92 percent to Rs 219.75 crore and total income fell by 1.09 percent to Rs 236.71 crore. Biocon's profit growth has been maintained at the consolidated level despite the divestment of the enzymes business, currency appreciation and increased depreciation. The company has a strong balance sheet with high reserves and Rs 193 crore in net cash. Commenting on the results, Kiran Mazumdar Shaw, chairman and managing director, Biocon, said, "We are pleased with our overall performance and have delivered the highest profits to date. We have increased our capital expenditure to support the business expansion that we anticipate across the group. We expect the year ahead to realize a good return on these investments, especially at Syngene and Clinigene. We have a strong balance sheet which we will use for strategic acquisitions and investments. Established in 1978, Biocon and its two subsidiary companies, Syngene International and Clinigene International form a fully integrated biotechnology enterprise, specializing in biopharmaceuticals, custom research and clinical research. With successful initiatives in clinical development, bioprocessing and global marketing, Biocon delivers products and solutions to partners and customers across the globe. Many of these products have USFDA and EMEA acceptance. Biocon launched the world's first recombinant human insulin, Insugen in November 2004 using Pichia expression and India's first indigenously produced monoclonal antibody BIOMAb-EGFR. Biocon last year acquired 70 percent controlling stake in German Pharma company, AxiCorp Gmbh, for a consideration of â‚¬30 million. This acquisition is expected to enable Biocon the marketing and distribution of a range of pharmaceuticals including generics, biosimilars, biologics and innovative pharmaceutical products in Germany and Europe. Biocon has commenced the phase IIa clinical trials for IN105. An open label, multi-centric, placebo controlled, single ascending dose study designed to evaluate safety, tolerability, pharmacokinetics and pharmacodynamics of IN105 under fed conditions in type II diabetic patients currently on Metformin therapy has been commenced at five investigation sites. The study is expected to be completed in August 2008 and will provide the data necessary to commence phase IIb clinical trials. In another major development, Biocon has commenced phase IIb trials for T1h for rheumatoid arthritis (RA) and psoriasis. A randomized, open label, four arms parallel phase II clinical study to evaluate the safety and efficacy of anti-CD6 monoclonal antibody (T1h mAb) in combination with Methotrexate in patients with active rheumatoid arthritis has been initiated at 7 investigation sites. Another phase II clinical trial to evaluate the safety, efficacy and pharmacokinetics of anti-CD6 monoclonal antibody (T1h mAb) in patients with active psoriasis is also due to commence at five investigation sites. This has been designed as a single blind, randomized, multiple dose, multiple schedule, multi-centric, parallel study in patients with active moderate to severe psoriasis, with independent blinded disease activity assessment, and quality of life metrics assessment. These clinical trials will enable Biocon establish proof of concept for T1h and will add tremendous value to its licensing potential. Biocon also commenced phase IIb trials for Glioma and NSCLC for BIOMAb EGFR. An open label, prospective, multi-centric study to evaluate the safety and efficacy of BIOMAb-EGFR (Nimotuzumab) as induction and maintenance therapy in combination with radiotherapy plus Temozolomide (concomitant and adjuvant) in Indian patients with Glioblastoma Multiforme is ongoing at eight investigational sites across the country. Another clinical trial designed as an open-label, randomized, comparative, multi-centric study to assess safety and efficacy of BIOMAb-EGFR and Nimotuzumab and in combination with chemotherapy versus chemotherapy alone in the treatment of patients with stage IIIB / IV Non Small Cell Lung Cancer (NSCLC) is also being initiated at 11 sites. These clinical trials will enable Biocon's oncotherapeutics division to expand its market share through label extensions. Biocon has decided to split up its cardio-diabetes group by launching a stand-alone cardiology division. This new division is being launched to focus on brand building for its flagship statin-based product Statix as well as other products viz. Telmisat, Eptifibatide and its recombinant streptokinase product Myokinase. This division is envisaged to have an all-India presence through a 250+ strong field force. Realizing the increasing demand in the market segment of pre-filled syringe systems over the past ten years, Biocon recently launched a safety device in the form of pre-filled syringes for two of its life saving products, GCSF (granulocyte-colony stimulating factor) and EPO (Erythropoietin). This innovative product has been launched in collaboration with Safety Syringes and is being introduced for the first time in India. ERYPRO Safe and NUFIL Safe will be the first two drugs that will be marketed using this novel device with other injectable products to follow in the future. Biocon's pre-filled syringe device incorporates features that provide for simple and safe handing, a discrete appearance of the injector and a retractable needle that reduces the chances of injuries during injection. Commenting on the launch of the pre-filled syringes, Kiran Mazumdar-Shaw explained, "The pharmaceutical industry has registered an increasing demand in the market segment of pre-filled syringe systems over the past ten years. These systems have the endorsement of healthcare professionals worldwide. There is a growing trend of injectable drugs moving into the pre-fill syringe as a presentation format. Worldwide, pre-filled syringe volumes have reached more than two billion units. The opportunity for Indian biotech companies in pre-filled syringes is immense as India is being viewed as a low-cost, high-quality manufacturing base. It has the largest number of USFDA approved plants outside the US." "Biocon stands committed to building big brands of products" -Dr Kiran Mazumdar-Shaw, CMD, Biocon The biopharmaceuticals business still accounts for 75 percent share of your total business. Going forward, how do you see the growth from this line of business? We are gearing up to increase our top line performance in biopharma. So the year ahead should see us delivering a better growth in terms of biopharma. We have grown by more than 100 percent in branded formulations sales compared to the previous year. We expect the growth to continue at this rate because the base is small. Biocon stands committed to build big brands of products like Insugen, BIOMAb-EGFR, and Statix.   What is the share of your statins business in your overall sales? The share of statins right now is about 33-34 percent of the biopharmaceutical revenue. Our dependence on statins is reducing and growth is coming from other areas as well.   What is the broad classification of your biopharmaceutical products and their respective contribution to your biopharma sales? I think statins is about a third of our business, immuno-suppressants and insulin account for another 25 percent, and then the rest are all miscellaneous products, including our branded formulations.   How much was the licensing income in the current year? It was about Rs 45 crore and is added in the biopharmaceutical business.   What is Biocon's licensing strategy? We have many programs to license. These are across the biosimilar and new drug molecule space. IN-105 is making good progress. We are in the process of conducting phase IIa trials and we will be entering into phase IIb trials, which is proof-of-concept trials. This is going to take another one year before we can really start aggressively licensing this molecule. As for T1h or anti-CD6, this is at the moment entering phase IIb trials, which are proof-of-concept trials that we need to evaluate in order to again make it ready for licensing. So, we believe that both these molecules will be available for licensing over the next 12-18 months and they are expected to deliver huge upsides. In addition, we have a pipeline of biosimilar molecules which we will continue to license as and when they complete some levels of clinical development. We already have quite a few products that are undergoing phase III clinical trials, like glargine and a few other products and once this happens, we will continuously look at licensing these out.   You have expanded to the Middle East... We have set up a marketing company called Neo-Biocon in the Middle-East. This is a joint venture between us and Dr Shetty's Research Laboratories, called Neopharma and we are right now in the process of registering our products in that territory. We established this company about 8-10 months back and by the end of this year, we will have all approvals in place. We will be starting our marketing activities in that territory by end of this year or beginning of next fiscal. ]]> <![CDATA["We're keen on entering into CRO or CMO segment"]]> https://biospectrumindia.com/news/95/6793/were-keen-on-entering-into-cro-or-cmo-segment.html https://biospectrumindia.com/news/95/6793/were-keen-on-entering-into-cro-or-cmo-segment.html Fri, 11 Jul 2008 13:33:00 +0530 New Page 1 "We're keen on entering into CRO or CMO segment" -Dr In-Chull Kim, president and CEO, LG Life Sciences LG Life Sciences (LGLS), an LG affiliate, is an R&D based biopharmaceutical company headquartered in Seoul, Korea. The company discovers, develops and commercializes new medicines in anti-infectives, cancer, diabetes and other chronic diseases. It is also engaged in animal health products, and specialty chemicals in South Korea. In an interview with BioSpectrum, Dr In-Chull Kim, president and CEO, LG Life Sciences shares his envisioned growth path for LGLS. Some excerpts: LG is a prominent player in electronics and chemicals industries. How did this diversification in biopharmaceuticals happen? LG has always been interested in investing in future technologies. Even at the government level, 10 technologies were selected as future growth of the country. One among them was biotechnology including biopharmaceuticals. And our involvement in pharmaceuticals dates back to 1981, when we began genetic engineering research as a division of LG Chemical. We started first with research and development rather than doing business. We focused on the development of synthetic and bioengineered drugs. Over a period of time, we have developed and commercialized an array of biopharmaceutical products for the first time in Korea, and later extended to other countries. These include interferon, hepatitis B vaccine, human growth hormone, degenerative arthritis treatment, recombinant human follicle stimulating hormone and sustained releasehuman growth hormone. Then we launched new chemical entities program-called new drug discovery during mid 1990. We were successful in getting approvals from USFDA. We got FDA approval, in 2003, for our next-generation quinolone antibiotic. The accomplishment has happened for the first time in Asia (excluding Japan). Since then we have been working on developing original drugs and filing applications at EMEA, a European agency and USFDA. We became the second company after Sandoz to get approval for biogeneric for human growth hormone from USFDA. We have to adapt our approach and our style of functioning to compete with the companies in the western world. And, we believe that meeting the global standards is key to our success. Do you have any collaboration with other companies or research organizations? Yes, we do have a number of collaborations with many organizations, both local and multinationals. We have collaborations with GSK, Pfizer, and now with Gilead Sciences, a successful biopharmaceutical company from the US. To be a successful company, we have to adapt a right strategy. For example, in India the successful companies besides being into research and development are also doing clinical services. We are also planning to launch such initiatives in Korea. Are you saying you are also looking at entering into services space? Yes, we are keen on entering into services space like CRO or CMO. In future, the revenue will come from products as well from services area. Overall, you can describe our business as a healthcare business instead of a pharmaceutical or biopharmaceutical business. Is there a timeline to start services activities? We will be starting services activities in the near future. Currently, we are focusing on launching the products. We have a number of products in pipeline. We are very competitive in the Korean market in terms of sales and marketing. Now, we have plans to set up our business in the US. We have the experience of setting up a research and development center in the US. We are thinking of setting up business operation to support our marketing initiatives like filing for product approvals with FDA and launching and utilizing direct sales capabilities in the US. The US is a very important market for any pharmaceutical company because of its market share. Do you foresee a future for LG Life Sciences in generics or biosimilars segment? We have some interests in generics. We believe, whatever we do should be a value-add in terms of intellectual property. Instead of commodity generics, we are interested in branded generics. It means through formulations, through some modifications to original product i.e., incremental modification, we can get the patents. Patent is the key. And our primary target is the US, followed by Japan and Europe. What is your take on the shrinking pharma market in Japan? You are right. The pharma market is shrinking with the rise of generics in Japan. In the last five years, the government of Japan has taken initiatives to minimize drug prices because of the burden on the healthcare expenditure. Generics is picking up in Japan and Korea. How generics will help the company increase its revenue? Everyone, now, is talking about the healthcare insurance. Some drugs are covered under government health insurance scheme while some are not. The current focus is on aging population in the developed countries. Those are the potential new areas for the pharma companies to target at. So, we are focusing on these niche areas, which might be prescription-based or OTC products, even at the R&D level. We are focusing on biological drugs and also on programs on monoclonal antibodies. At the same time, we are utilizing interesting materials to develop the new products that are not covered under government healthcare insurance like ointments. Even at the research level, we have adopted a hybrid strategy. Anyway we have to show profits. What are your thoughts on inorganic growth? Now, we are thinking about M&A. We are looking at many smaller companies instead of just one big company. We learnt a lot from the big pharma companies in the last 10 years. We have to follow our own styles or models or business approaches. In order to be a successful company, we have to change our perspectives and thinking process. That is what I have been emphasizing to my people in the organization. We have to change our old habits and adapt to the new habits. We have look at the things based on the perspective of the customers and not on the views of the scientist and the businessman. Customers' perspective is most important factor for any company. Considering the potential of Asian markets, do you have any plans of setting up subsidiaries in the region? As I said earlier, our first priority will be the US. However, we are preparing to register in China as well. We already have presence in India. We will continue to maximize our capabilities in the region. How do you look at Korea as a market for the range of products you have? Korea is a mature market, but the distribution system in Korea is very complex. The Korean government is discussing a free trade agreement with the US government. Both the governments have agreed upon the agreement. And this year, it will be placed before the parliament of respective governments. Once it is ratified, it will open the doors for everyone in Korea. We have an open competitive system in Korea. In the next five years, there will be a lot changes in Korea. How does the future for biotechnology industry in Korea look to you? There is a good scope for biotechnology. The government has been driving the industry. Annually, it has been increasing the budget for R&D for not only academia but also for the industry sector. However, in my view, the government should provide R&D funds for the not only for Korean companies but also for the multinational companies in the form of tax incentives. I personally feel it will bring in more investments into the country and generate employment opportunities. Narayan Kulkarni in Singapore ]]> <![CDATA[India & China can complement each other in pharma space]]> https://biospectrumindia.com/news/95/2932/india-china-can-complement-each-other-in-pharma-space.html https://biospectrumindia.com/news/95/2932/india-china-can-complement-each-other-in-pharma-space.html Fri, 11 Jul 2008 12:23:00 +0530 New Page 1 India & China can complement each other in pharma space There lie huge opportunities for India and China to make most of the global outsourcing pie in the entire pharmaceutical value chain. It depends on the way the two nations create new competencies and leverage existing competencies globally. Shivani Shukla Raval, industry manager, healthcare practice, Frost & Sullivan It all began in China, when the whole world looked in awe as the Chinese economy began to take off in the 1980s as the country positioned itself as a global economic power. China leveraged its immense domestic savings to develop infrastructure and invested large amounts of foreign money to build large scale manufacturing capabilities. India started its journey towards economic transformation about a decade after China but has proven itself more than a match for the larger country by creating world renowned knowledge based industries like software, IT services and pharmaceuticals. In fact, India is lately grabbing a lot of attention due to a robust financial system and liberal government policies. Today, these two developing economies are slowly accumulating power, weight and dynamism to transform the 21st-century global economy. The world is now witnessing a simultaneous, sustained and synergistic takeoffs of two giants that together account for one-third of the world's population. What makes these two countries especially powerful is that they complement each other's strengths. An accelerating trend is that technical and managerial skills in both China and India are becoming more important than cheap assembly labor. Hence, China is dominant in mass manufacturing, and is one of the few nations building multibillion-dollar electronics and heavy industrial plants, while India is a rising power in software, design, services, and precision industry. Given their own unique strengths, both the countries are set to be amongst the top three economies in the world in the coming decades. Pharmaceutical industry dynamics between India & China India and China have benefited a lot from the attention of the global pharma industry both in terms of the vast domestic opportunities provided by these two countries as well as the outsourcing boom Indian pharmaceutical industry: The pharmaceutical industry in India is one of the fastest growing sectors. The industry has achieved global recognition as a producer of generic products and low-cost high-quality bulk drugs and formulations. Majority of the leading companies have established market presence in more than 200 countries, which also includes the US and major European countries. The year 2005 saw India entering the product patent regime. During the transition phase, domestic pharmaceutical companies, which grew by reverse engineering, started focusing on innovative drug development. Top domestic pharmaceutical firms are investing 10 to 12 percent of their revenues in R&D. At the other end, as India has TRIPS compatible IPR norms, multinational pharmaceutical companies are gradually entering India either directly or through alliances. The advent of the product patent regime, has also led to an increasing number of innovator drugs being launched in India Apart from growth in the domestic market, to take advantage of the global generic opportunity, and to assert their global competitiveness in terms of cost competitiveness and availability of skilled manpower, Indian companies are on an aggressive ANDA filing spree and getting their manufacturing facilities certified by International regulatory authorities. Currently, India has the highest number of USFDA approved facilities outside the US, which in turn serve as global low cost, outsourced, drug manufacturing hubs for international companies. Global MNCs are also looking to outsource their research and product development needs to India. Multinational companies have established their subsidiaries in India with an endeavor to market drugs and conduct low cost clinical trials. Indian pharmaceutical research, manufacturing, and outsourcing have thus received an impetus, thereby, creating an image of an immensely potential healthcare market and a land of opportunities in pharmaceuticals.   Macroeconomic dynamics between China and India Parameters China India GDP (PPP), 2006 US $10.0 Trillion US $4.042 Trillion GDP per capita (2006, PPP) US $7,593 US $3,700 GDP by sector (2005 estimate) Agriculture:12.6% Industry:47.28% Services: 40.26% Agriculture: 19.9% Industry: 19.3% Services: 60.7% GDP Growth Rate 10.7% 9.2% Population 1.3 billion people 1.095 billion people Labor force by occupation (2006 estimate) Agriculture: 45% Industry: 24% Services: 31% Agriculture: 53% Industry:14% Services:33% Labor force (2006 estimate) 798.1 million 509.3 million Inflation rate (2005) 2.8% 5.3% Source: Frost & Sullivan   Currently, Indian companies are spending less than 7-10 percent of their revenues in R&D, while this percent is as high as 18.0 percent for multinational pharmaceutical majors. However, the increasing realization of potentials in pharma R&D is moving Indian pharmaceutical industry to a more research-driven business strategy. Companies such as Dr Reddy's Laboratories and Nicholas Piramal are successfully setting the standards for other Indian companies. There is also an increase in collaborative outsourcing to India. The number of international pharmaceutical firms with a research presence in India have increased significantly during the past five years. Chinese pharmaceutical industry: Today, the Chinese pharmaceutical market is growing with impressive double digit pace. A rising activity in the Chinese life sciences arena has been reported with the increasing high-level support from the government. The thriving generic and bulk active drugs market continue to be the mainstay for the Chinese domestic drug industry with an estimated 90 percent of the drugs in the market being generics. The Chinese pharmaceutical market is highly fragmented with thousands of small pharmaceutical companies involved in manufacturing one or two generic drugs. Quality control concerns and cost concerns are also present among the manufacturers in China. These led to increased supervision from the government to maintain the quality of the pharmaceutical products. Also, with the increased interference from the government, a gradual shift from generic to innovation led to the development of contract research markets, which resulted in increased partnership with multinational pharmaceutical companies and other bodies. The inherent limiting conditions prevalent in this country have curbed the Western firms from full capitalization on R&D potentials. Chinese pharmaceutical companies are now striving to adopt a research-oriented business model. The market for traditional Chinese medicines (TCM) is huge in China with over 1,000 companies competing for the market share. The technological developments and also the drying output from Western R&D have fueled the development of Western medicines based on TCM principle. Although there are burgeoning efforts from Chinese pharmaceutical companies to innovate and sustain in the competitive environment, a further increase in R&D investment is required for the active innovative Chinese industry. Major pharmaceutical companies such as Hoffmann La Roche, GlaxoSmithKline, Eli Lilly and Pfizer have established joint ventures and wholly owned subsidiaries in China. However, sales in China for these companies account for a small portion of their global sales. It is not only the pharmaceutical companies that are trying to establish R&D and manufacturing operations, but a number of international CROs are also trying to establish offices in China. It is reported that clinical research expenses in China can be as low as one-tenth than those in Western countries. However, the legal challenges for drug approval are the most limiting factors for pharmaceutical companies. CROs are capitalizing on this issue by providing local expertise for pharmaceutical companies to steer through the complex Chinese legal system. Reasons for the increasing outsourcing boom Today, a growing list of pharmaceutical companies is examining the opportunities in low-cost Asian countries such as India and China. Over the years, India and China have been the subject of many debates, and comparisons. Both the countries have their own set of strengths and weaknesses, some shared and some unshared. Seen from a competitive angle, India and China are the biggest rivals. But from a collaboration perspective, these two emerging economic giants have much to offer each other. There lie huge opportunities for India and China to make most of the global outsourcing pie in the entire pharmaceutical value chain. It depends on the way the two nations create new competencies and leverage existing competencies globally.   ]]> <![CDATA[Indian biopharma industry coming of age]]> https://biospectrumindia.com/news/95/1384/indian-biopharma-industry-coming-of-age.html https://biospectrumindia.com/news/95/1384/indian-biopharma-industry-coming-of-age.html Fri, 11 Jul 2008 12:11:00 +0530 New Page 1 Indian biopharma industry coming of age It is important to understand the evolution of biomanufacturing in India in the context of the evolution of the pharmaceutical industry in India and the driving forces that led India to become an important player in the world-wide pharmaceutical manufacturing and supply business Shrikumar Suryanarayan, director general, Association of Biotechnology Led Enterprises India (ABLE) At least one out every two children in the world is vaccinated with a vaccine produced in India and that was achieved more than five years ago. This astonishing feat of Pune-based Serum Institute of India and possibly the world's largest vaccine manufacturer of measles and DTP vaccines, is an eloquent testimony to India's biopharmaceutical manufacturing capabilities. Further down south in Bangalore, Biocon, a company led by Dr Kiran Mazumdar-Shaw, sometimes referred to as the richest woman in India, has a sprawling manufacturing campus spread over two locations, totalling over a 130 acres with state-of-the-art biologicals manufacturing. Biocon is the largest manufacturer of Insulin in Asia, which incidentally is also home to the world's largest number of diabetics. Biocon is also India's largest manufacturer of recombinant monoclonal antibodies with a proprietary new product BioMab, a humanized anti-EGFR monoclonal antibody which represents a generational improvement over Erbitux. North of Bangalore, in Hyderabad is Shanta Biotechnics who developed and launched a recombinant Hepatitis B vaccine against stiff competition from big pharma and ultimately succeeded in making Heb-B vaccination highly affordable in India. India produces a large number of its own vaccines and recombinant biopharmaceuticals. It is important to understand the evolution of biomanufacturing in India in the context of the evolution of the pharmaceutical industry in India and the driving forces that led India to become an important player in the world-wide pharmaceutical manufacturing and supply business. In 1995, India signed the GATT agreement and became a signatory to the products patents regime with a 10-year holiday period. This meant that from 2005 onwards, pharmaceutical products that were discovered and patented after 1995 could no longer be produced in India without violating the rights of the patent holder. Prior to that, India only used to recognize "process patents" which meant that companies in India could freely produce a pharmaceutical molecule sold under patent elsewhere in the world, provided that they did not infringe upon the innovators manufacturing process. In other words the "process patent" regime forced Indian companies to innovate in manufacturing process since they could not copy the innovator's process. Another aspect of the ecosystem that impacted these developments was the fact that India had no nationwide system of health insurance for the public. Individuals had to pay for their own medicines and medical treatment and this put an enormous pressure on the drug manufacturers to develop processes that were efficient and cost-effective. As a result of this, drug prices in India are among the lowest in the world. However, this is also a fact that there is practically no new medicine in widespread use in India which was discovered and developed in India. Some of the biopharmaceuticals manufactured in India Companies Products Serum Institute of India (www.seruminstitute.com) Viral and bacterial vaccines against measles, rabies, DPT, BCG Biocon (www.biocon.com) Insulin, erythropoetin, monoclonal antibodies, GCSF, streptokinase Shantha Biotechnics (www.shanthabiotech.com)   Vaccines - Hepatititis-B, DPT, erythropoetin, Interferon alpha   Dr Reddy's Laboratories (www.drreddys.com/innovations/bio_mproducts.htm) GCSF, monoclonal antibodies Wockhardt (www.wockhardt.com/biopharmaceuticals.html)   Erythropoetin, insulin, Hepatitis B vaccine   Panacea Biotech (www.panacea-biotec.com/Vaccines_product.html) Vaccines â€“ Hepatitis B, DPT, Poliomycetes   Bharath Biotech (www.bharatbiotech.com/products.htm) Vaccines- Hepatitis, polio, typhoid , tetanus, rotavirus vaccine, streptokinase Intas Pharmaceuticals (www.intasbiopharma.co.in/biotech.html) Peg-GCSF, GCSF, erythropoetin, Interferon alfa 2b. The opportunity to innovate on process development led to the development of a large pool of extremely skilled "process chemists" which has also led to the fact that India is now a preferred destination for outsourcing process development and chemistry research. As an example, very recently Bristol Myers Squibb signed a major contract with Syngene International, a Bangalore-based company, to set up an R&D unit housing more than 400 chemists on an exclusive basis for them. The need for cost-effective biopharmaceuticals has similarly impacted the development of generic biopharmaceuticals in India. Of course, it is clear that biopharmaceuticals are far more difficult to produce than chemical molecules and establishing equivalence is not a trivial task and may require clinical trials to be carried out. However this is not a show-stopper in many cases since India's large population and patient availability and thereby faster patient recruitment makes the time and cost of doing a clinical trial in India far more affordable than elsewhere. Incidentally, given its preponderance of doctors trained in western systems of medicine and its familiarity with English languageâ€“India is also a preferred destination for clinical trials and attracts an increasing percentage of worldwide clinical trial business. With the advent of the product patent regime since 2005, a slow but significant shift has been occurring in the pharmaceutical companies in India. With the number of products that can be "copied" declining, Indian companies have begun to invest heavily in discovery and development of novel products. This is a very slow and tedious process and it is unclear at the moment whether the knowledge base to do this exists in India. However, just as it happened in the software arena, India is blessed with a large diaspora who emigrated several years ago to the US and to Europe and who have achieved leadership positions in the pharmaceutical and biopharmaceutical industries. As the Indian economy expands and becomes robust, more and more of the Indian diaspora is being attracted back to work here by a combination of opportunity and economic incentives. In recent years many of the large Indian pharmaceutical companies have employed several such "returnees" in senior management positions in their R&D divisions. Such people bring back a wealth of experience with them to "inject" into the system. With the cost of drug development in India still being significantly lower than in the west and thereby leading to an "affordable cost of failure" it is entirely possible that in the near future there will be more and more companies willing to take on the risk of drug development. Biocon and Shanta Biotechnics are examples of companies that have already taken the lead to develop novel biotherapeutics. In the small molecule space several other companies like Dr Reddy's and Glenmark Pharmaceuticals have already made their mark. To conclude, India is currently a prominent supplier of "generic" drugs and biopharmaceutical products. In the future it is entirely possible that novel and affordable drugs will be developed in India and marketed worldwide. About the author Shrikumar Suryanarayan is the director general of the Association of Biotechnology Led Enterprises (ABLE), headquartered in Bangalore. He is also an Adjunct Professor in the Department of Biotechnology at the Indian Institute of Technology, Madras as well as a visiting faculty at the Department of Molecular Medicine at the Karolinska Institute. Prior to this, Shrikumar was the president of R&D at Biocon and has more than 23 years of biotechnology industry experience.   ]]> <![CDATA[On Einstein's tracks: Dependent patents & selection inventions]]> https://biospectrumindia.com/news/95/2626/on-einsteins-tracks-dependent-patents-selection-inventions.html https://biospectrumindia.com/news/95/2626/on-einsteins-tracks-dependent-patents-selection-inventions.html Fri, 11 Jul 2008 11:56:00 +0530 New Page 1 On Einstein's tracks: Dependent patents & selection inventions Dr Thomas Westphal and Dr Ralf D Kirsch A lot of findings that come up in R&D may be patentable in Europe, even if they fall into a broader range of a pre-existing "ruling" patent. Patents, which cannot be used without falling into the scope of another "ruling" patent, are so-called "dependent patents". The comments of Albert Einstein on "dependent patents" concerning a patent case in the year 1919 are still valid today. Dependent patents in the biotech field are often based on a "selection invention", where a selection of a narrow region having surprising effects is made within a broader, known region (e.g. certain dose ranges of a pharmaceutical formulation, enzymes etc.). Selection inventions are usually patentable and this works particularly well as a European patent. Unfortunately, one exception is Germany, where the national case law on selection inventions is more restrictive. Thoughts of Albert Einstein on dependent patents Did you know that Albert Einstein, the famous physician, was employed as a patent examiner at the Swiss Patent Office? If not, you will be even more surprised to learn that he was also a much valued expert in patent infringement proceedings, e.g. in the case, Anschuetz & Co. contra. Kreiselbau-Gesellschaft mbH., which was on the infringement of a patent granted in 1917 for an airplane part. The Einstein expert opinion on this has been published (The Collected Papers of Albert Einstein, Volume 7, The Berlin Years: Writings, 1918-1921, Doc.21, Court Expert Opinion in the Matter of AnschÃ¼tz & Co. contra Kreiselbau-Gesellschaft mbH., Princeton University Press 2002) and it is of particular interest with regard to selection inventions as biotech or pharmaceutical patents. After Einstein had commented on the questions raised in the infringement proceedings in his expert opinion, he explained his model on a "dependent invention". The dilemma of an inventor who owns a "dependent invention" is that he cannot work his invention (independent of whether it is patented or not). This is because the dependent invention falls into the scope of the ruling patent, the owner of which has a prohibitive right that is granted by the patent. This is in line with one fundamental rule of patent law, i.e. to exclude others from using the invention. Thus, it is not surprising that disputes as in the infringement proceedings mentioned above, in which Einstein gave his infringement opinion, as well as during licensing negotiations do occur. Here, the owner of the dependent invention is dependent on the goodwill of the owner of the ruling patent, which is usually accomplished in return for services such as the payment of licensing fees. The owner of the dependent patent (e.g. on a "selection invention") can strengthen his position vis-Ã -vis the owner of the ruling patent by filing a patent application for his dependent invention himself, which could be effectively used in the negotiations. Still, the owner of the ruling patent would have a prohibitive right also for the dependent patent. That means that without the approval of the ruling patent's owner, it is not possible for the owner of the dependent patent to "work" the invention. The way out of this dilemma is usually by exchanging licences ("cross licensing") by which both of the parties allow each other to commercially use the respective invention against the payment of a licence fee. If the licensing negotiations are not successful the dependent patent (e.g. on a "selection invention") can often only be commercially exploited after the ruling patent has lapsed. This, however, is usually too late for a return on investment. The additional possibility of a "compulsory license" on a ruling patent is not further discussed here. Einstein speak "... To each invention described in a patent belongs a certain region G of options on how to realize the patented invention. Let us think of said region G as a certain, limited area of a plane of all possibilities ... Subject-matter that is part of the invention can be thought of as a point (black circle) within said region G. Would the inventor of the patent that is protecting the region G have complete knowledge of all the possible embodiments of the invention, he would indeed be without any doubt the intellectual owner of all possible embodiments of his invention. In real life, however, the inventor never has a complete overview on all the possible embodiments of his invention. In a way, he does not know about all of the points in his region G, but only about a certain limited number of points of this region. However, there can be embodiments of the invention of which the inventor himself had not thought of, and which bring about novel, characteristic technical advantages (the finding of valuable points P or subregions of the region G, which had not previously been seen). In such a case, one can speak of a "dependent invention". The question of whether to assign an inventor of a "dependent invention" any rights is not to be discussed by myself; this is up to the attorneys ...". Selection inventions are important in biotech What is now exciting about all this is that "selection inventions" are particularly important in the biotech and pharmaceutical area. As an example, let us assume that there is a ruling patent of a company A that protects an organic or biological compound X for the treatment of a disease Y (unlike in India, medical use claims are possible in Europe). The upper limit of the daily dose is given in the patent as 20 mg, and the examples in the patent disclose daily doses of 15, 18 and 20 mg. However, the R&D of a competitor, company B, has found to their big surprise that compound X is at least 100 times more effective when it is administered to the patient in a daily dose of only 1-3 mg (let us disregard the molecular mechanism that may be the basis for this). First, this subregion of 1-3 mg is narrow in comparison to the known, patented region (up to 20 mg). Second, it is distant from the examples of the known, patented region (15, 18 and 20 mg) and third, it is not a randomly chosen subregion â€“ instead it is a purposive selection of a region, since it could be shown that the surprisingly high effectiveness can only be seen in that particular subregion of 1-3 mg (in contrast to an arbitrary selection). Such a "selection invention" is patentable in Europe, as has been laid down in one of the hallmark decisions of the Technical Boards of Appeal of the EPO (T 198/94, Hoechst/Thiochloroformates, OJ EPO, 1985, p.209). These three criteria for a selection invention have been the basis for more recent decisions of the EPO. Obviously, a lot of variations of this example could be envisaged, e.g. selection of other doses (units of enzyme, doses of particular factors or other parameters). What this means for a biotech or pharmaceutical company in India is that a lot of findings that come up in R&D may be patentable in Europe, even if they fall into a broader range of a pre-existing "ruling" patent. A German problem - no patents for selection inventions in Germany Although the option of a selection invention is open for European Patents, there is a problem: the German part of this European patent is unlikely to last very long, since German case law has not accepted the principle of a "selection invention" (i.e. the German part is open to attack by a nullity suit in Germany). In short, German courts have taken the view that e.g. 1-3 mg is comprised in "up to 20 mg" and therefore an invention on that subregion a priori cannot be novel. Other countries in Europe, e.g. the UK, do have a practice of granting patents for selection inventions that is similar to the EPO practice. One can only hope that German case law will slowly come closer to the EPO practice of granting patents for selection inventions. Inventors all over the world who have made tremendous efforts in R&D deserve it. About the authors Dr Ralf D Kirsch studied biology in Konstanz, Germany, and went into research in molecular biology and cellular and molecular immunology at the University of Cambridge, UK, where he did his PhD. After his science period in Cambridge, he did a postdoc at the Max-Delbrueck-Centre for Molecular Medicine in Berlin, Germany, also in the field of cellular and molecular immunology (kirsch@glawe.de). Dr Thomas Westphal studied biology in Moscow and spent years in research in genetics, molecular biology and biochemistry at the Lomonossow University in Moscow as well as at the Martin Luther University in Halle, Germany. He is active in the field of patents and trademarks. Claus Becker has been working with GLAWE DELFS MOLL since 2007. He studied aerospace engineering at the University of Stuttgart, Germany. Claus Becker is working on intellectual property cases in the fields of medical engineering and laboratory technology.     ]]> <![CDATA[India an emerging player in bioinformatics]]> https://biospectrumindia.com/news/95/3823/india-an-emerging-player-in-bioinformatics.html https://biospectrumindia.com/news/95/3823/india-an-emerging-player-in-bioinformatics.html Fri, 11 Jul 2008 11:44:00 +0530 New Page 1 India an emerging player in bioinformatics The Indian bioinformatics sector is now growing rapidly, gathering nourishment from the software and life sciences industries in the country. Dr Vijay Chandru, Chairman and CEO, Strand Life Sciences, Bangalore. The bioinformatics industry in the country has so far progressed like any normal new sector: initial rush, many mistakes, some closures, new births, difficult periods, and a few happy moments. The industry everybody imagined in the year 2000 was never born. But the Indian bioinformatics industry is now growing rapidly, gathering nourishment from the software and life sciences industries in the country. India is not a force in global bioinformatics in any sense, but several Indian companies are building healthy businesses that could sustain themselves without hand-holding, and one day help the country's drug discovery programs. There are three distinct kinds of bioinformatics companies in India now. The large IT companies are now diversifying into bioinformatics, and some of them have large divisions devoted to life sciences. A second group consists of companies that began as start-ups a few years ago, and have now retained their original nature or have acquired other related businesses on the way. The third is captive bioinformatics groups within large pharmaceutical and biotechnology companies that use some bioinformatics for their research. To these we could add a fourth academic sector, the national laboratories and universities. Almost all the large IT services companies in India have been looking at bioinformatics with interest from as early as the year 2001. Indian majors like Wipro, HCL, TCS and Infosys all have large life sciences divisions. The substantive engagements are structured around data warehousing and integration (particularly in regulated sectors like clinical and manufacturing) as well as applications support (with large on-site presence). Cognizant also has a strong play in informatics for marketing related activities after the acquisition of MarketRx. In terms of overall size, some estimates run close to $1 billion in business that this sector generates for the IT services companies, although the actual bioinformatics content of what many of these companies do is difficult to measure. There is clearly gradual progress in the life sciences domain expertise in the services offering of the IT majors. Some early bioinformatics companies like GVK Sciences, Jubilant Biosys, Ocimum Biosolutions, and Chembiotek have turned into broader contract research organizations and their bioinformatics business is a minor part of their strategy. Newer agile start-ups doing informatics driven discovery include Connexios and V-Life. Molecular Connections is one pure play content company that remains in the fray as does Strand Life Sciences which has a mixed products and consulting business model. Return of Bioinformatics Bioinformatics has had a long history and its early beginnings can be traced to the needs of structural biology and crystallography. The 1990s was an important decade for the computational sciences for two major reasons. The Internet was growing at an exponential speed and technologies of storage, retrieval and search were rapidly evolving to meet this challenge. In parallel, the human genome project was on and was leading the pack of biology transducers (the digitization of biology) that promised to affect almost every frontier of computer science. The world has become hugely influenced by clever marketing and these two great innovations, Internet and Genomics, both had their share of hype leading to a bubble (unreal and poor investments) and then a burst (reality check). In India, the dotcom bubble burst did not have a large effect since our fortunes were tied more closely to outsourcing of software services from more traditional sectors of the Western economies. The genomics burst, very evident from 2002 through 2004, caused a general shutdown in the funding of bioinformatics companies, both in the West and in India. The role of the public institutions and educational institutions in keeping the bioinformatics flame burning became very critical. The good news today in 2008 is that there is a general revival of fortunes in the genomics business. Genomics has now some proven value propositions unlike the hype at the turn of the millennium. Just like the Internet companies whose fortunes turned around when Google proved the Internet had value, the genomics business is looking for a pivot. Where will this pivot come from? One possibility is that genomics will revive around the new biomarkers, diagnostics and patient profiling emerging from the efforts of high throughput experimental work on the genetics of disease carried out in the last 5-10 years. An example of commercial success in this mode is the company Genomic Health, based in SiliconValley (USA), that has a diagnostic for prediction of risk associated with breast cancer recurrence which leads to guidelines for chemotherapy regimes. This diagnostic is in use today and insurance companies like Aetna have agreed to pay for the diagnostic. At last count this company was generating about $100 million in revenue at a market capital valuation of $550 million. The buzz around "Next Generation Sequencing" which has brought the cost of human genome sequencing to the sub-million $ mark and is raising the prospect of "consumer genomics" paid for by insurance to within reach in a couple of years. Google and MicroSoft are electrifying the space with investments and actions that depict the seriousness of their intentions. This bodes well for the "Return of Bioinformatics". What will be India's share of this cake?   ]]> <![CDATA[Industry growth slides to 20 percent]]> https://biospectrumindia.com/news/95/2777/industry-growth-slides-to-20-percent.html https://biospectrumindia.com/news/95/2777/industry-growth-slides-to-20-percent.html Fri, 11 Jul 2008 11:06:00 +0530 New Page 1 Industry growth slides to 20 percent The Indian biotech industry notches $2.5 billion in revenues, recording 20 percent growth, the lowest annual increase in the last five years. The industry was growing at a CAGR of 34 percent since 2003 and the 20 percent growth this year appears to be the pause before the next level of growth happens. BioSpectrum called FY2006-07 as the year of GMP-Globalization, Maturity, and Products. And this year's survey clearly reflects the continuation of that trend. First, the Indian biotech industry recorded $2.5 billion in revenues and the 30 percent growth rate that was being witnessed for the past five years has slumped to 20 percent and is more congruous with the global line. The global biotech industry in 2007 grew at about 8 percent, while the Asia-Pacific region registered a growth of 21 percent. This is an indication that the biotech sector is consolidating and the spurt in growth will happen when the industry moves to the next level of change. The signs of the change are visible. The most important sign of this change is increase in activities related to localization of global companies and globalization of Indian companies. This is an important development as in the past one talked about attracting investments to India--only global companies coming to India. However, this trend has reversed and now it is a two-way thoroughfare and in equal proportions. This will spike up the growth. The indication of this change is in the deals like Ranbaxy-Daiichi Sankyo (Japan), RFCL-Bremer Pharma (Germany), Manipal AcuNova-Ecron (Germany), Jubilant Biosys-Forest Laboratories (US), and Intas Biopharmaceuticals-Biologics Process Development (US). Almost a dozen deals must have been signed during January-June 2008 alone. These are cross-border deals as well as deals within the companies in India. An important development that one cannot ignore is the Ranbaxy-Daiichi Sankyo deal. So far Asian pharma and biotech companies were involved in dozens of cross-borders merger deals, mainly in Europe and the US markets in recent years. Now the attention is turned to the region itself. The acquisition of India's second largest drug maker, the S1.05 billion Ranbaxy by Japan's $9.6 billion Daiichi Sankyo is a landmark step. For it is set to change the way Asia's strong and vibrant pharma companies are going to play the game hereafter. The industry in 2007-08 clocked $2.5 billion (Rs 10,273.7 crore) in revenues, registering 30.98 percent growth, over the previous year's figure of $2.08 billion (Rs 8,541 core). The biopharma segment continues as the largest contributor to the biotech industry revenues. During 2007-08, it recorded sales in excess of $1.72 billion (Rs 6,899 crore) and accounted for 67 percent of the total industry revenues, registering 16 percent growth. The biotech exports grew to Rs 5,733.7 crore. The share of exports in the total biotech pie is close to 56 percent. Exports from biopharma alone accounted for over 70 percent of the total industry, while the bioservices sector had 26 percent share in exports (Rs 1,502 crore). The bioservices sector registered 53 percent growth. The bioagri sector grew by 30 percent to Rs 1,202 crore, the bioindustrial sector by 4 percent to Rs 410, and the bioinformatics sector by 31 percent to clock Rs 190 crore in revenues. In 2007-08, the investments touched Rs 2,750 crore, up by over 21 percent compared to the previous fiscal. Based on the current trends and the new progressive biotech policy in place, the forecast for 2015 is that the Indian biotech industry would be about $13-16 billion revenue. ]]> <![CDATA[Open source drug discovery]]> https://biospectrumindia.com/news/95/5026/open-source-drug-discovery.html https://biospectrumindia.com/news/95/5026/open-source-drug-discovery.html Thu, 05 Jun 2008 09:30:00 +0530 New Page 1 Open source drug discovery Use of non-proprietary computer software through what are called "Open Source" platforms has been popular for more than a decade. And thousands of communities of software programmers around the world have spent their time and energy to enhance the use of such software to increase the use of reliable free software. Now, India's leading public network of laboratories under the Council of Scientific and Industrial Research (CSIR) has formulated a similar program to enhance the prohibitively expensive drug discovery process. The $38 million (Rs 160 crore) plan, called Open Source Drug Discovery (OSDD), unveiled by the CSIR chief, Dr Samir Brahmachari, is an innovative attempt to lower the cost of drug discovery from over $1.2 billion and 12-15 years to reasonable levels. OSDD aims to ensure free sharing of information about the drug discovery process using an Internet-enabled platform, The drug discovery process will be broken up into small and simpler tasks and scientists, researchers and students will be able to contribute their own solutions. All information related to any drug developed under the program will be made available in the public domain to ensure universal access. There will be no intellectual property rights on any component of the process and every individual or company with capabilities will be able commercially exploit the subsequent product. This is a commendable effort to take the mystery out of the drug discovery process. And those entrepreneurs who plan to serve the humanity by taking up these discoveries by turning them into medicines will have help from another government agency, the Department of Biotechnology (DBT). The Small Business Innovation Research Initiative (SBIRI), an offshoot of the National Biotechnology Policy, has been trying its best to help such entrepreneurs. So far, the DBT has given over Rs 155 crore to 37 such projects, most of them in the drug discovery area, to 32 companies. According to the latest data from the DBT, over three-fourths of the 398 fund request proposals have been for early stage drug discovery research and another 20 percent were for scale-up and late stage development of research programs. This is a heartening development which will go a long way in sustaining the growth of the biotechnology segment. While Indian companies are getting into the drug discovery process with gusto, foreign companies have also started to introduce their latest products in the Indian market. The wait for one of the recent blockbuster drug, Gardasil, the cervical cancer vaccine, marketed by Merck around the world, will be available in India soon. Merck will start the clinical trials of this drug, developed by Australia's top pharma company, CSL. It will be a boon to the millions of young women in the country who could be saved from this dreaded disease with the use of Gardasil. Merck has promised to make it available to the needy Indian patients at affordable rates. The publishing industry is going through a ferment. Even the most popular television channels have started using content from the viewers, through Citizen Journalist. Some foreign publications have come out with predominantly user generated content (UGC). For over five years now, BioSpectrum has tried to reflect the issues that are of the greatest concern to the biotech community. To take this forward further, the September issue of BioSpectrum will be 100 percent dedicated to User Generated Content. That is every piece of information in it will be what the reader wants and what they provide. So don't wait. Go ahead and flood us with what you would like to see in the September issue. The BioSpectrum team will be involved only to edit the copy and tailor it to the format of the magazine. Happy writing! <sureshn@cybermedia.co.in> ]]> <![CDATA["Our growth has primarily been through acquisitions"]]> https://biospectrumindia.com/news/95/5021/our-growth-has-primarily-been-through-acquisitions.html https://biospectrumindia.com/news/95/5021/our-growth-has-primarily-been-through-acquisitions.html Thu, 05 Jun 2008 09:23:00 +0530 New Page 1 "Our growth has primarily been through acquisitions" -Ann O'Hara, GM, life sciences services, GE Healthcare The UK-based GE Healthcare is a $17-billion unit of General Electric and is a leader in providing expertise in medical diagnostics, patient monitoring systems, disease research, drug discovery, biopharmaceutical manufacturing technologies and purification products. In an interview, Ann O'Hara, general manager, life sciences services, GE Healthcare, shares her thoughts about the market opportunities for the company in the Asia Pacific region. Excerpts: What is the company's approach and strategy? Our approach is to help the healthcare and the life sciences industry. Our three main focus areas are diagnostics that comprise most of our business in terms of revenue, then life sciences and lastly the IT component. Our growth in life sciences and IT have primarily been through acquisitions. Getting into developing a bigger vision, we acquired Amersham four years ago and getting in to IT, we acquired several companies in the last 10 years. In the Amersham acquisition this component we call life sciences is primarily made up of products and services that help scientists to research and develop therapies, unlock nature's secrets and also produce therapies for the patients. What we want to provide in this arena are leading technologies that help customers save time, money and save costs. We have leading expertise in proteins and we are also developing products in genomics. Which are the products that have fetched in good revenue for the company? We have a range of products having the name AKTA, the laboratory brand for purifying biomolecules. Every lab that purifies proteins utilizes this product. So that is the biggest product. We cover a broad range of products but the absolute areas where we are leading are purification of biomolecules and characterization of biomolecules. The technologies are originally coming from Pharmacia, Amersham, Biacore, GE and the other companies that GE has acquired. For expanding its portfolio of products, GE has acquired companies like Wave, which is into cell culture for growing mammalian cells and then acquired Biacore, another company which we bought a year ago is into the analyzing interaction between molecules. The most recent one is Whatman. It develops and manufactures filtration technologies and devices used in biomedical research, quality control testing, clinical diagnostics and medical equipment. So far, we are very successful with our protein purification products. It would not be wrong to say that 95 percent of the monoclonal antibodies that are used in therapy are purified using GE life sciences products and what we are trying to do now is to make those technologies and products more efficient, lean and better. We also have one of our global research centers in Bangalore. We have one in the US, one in China and one in Munich. How is molecular imaging doing in the market? Our molecular imaging is at a nascent stage now. However, the molecular imaging program is quite inspiring because we have a lot of expertise in multiple different functions and different industries and also because we have a number of partnerships with universities. What are the market opportunities in the Asia-Pacific region? Asia is an incredible untapped market in terms of its potential and is a very large region. The development of the pharmaceutical and biopharmaceutical industry has just begun. So there's an amazing amount of progress to be made with patients, from vaccines to various therapies, cancer, diabetes etc. So what we see following behind that is also a rapid development happening in the scientific expertise. Asia as a region respects education. There is a huge number of scientists and engineers graduating in Asia every year. We as a company see a tremendous asset of talent here. We have been in this region in terms of gaining expertise and access to population of scientists. Our customers here are not just making products for the local market but also for exports. So we want to be along their side and help them in serving better globally. In terms of our business, India has a fantastic opportunity. India has the communication advantage over China. And in the next few years we will certainly be developing products, which are more suitable for India and at an Indian market price. What differentiates GE from its competitors? First of all, it starts with the strong history of technology and GE's portfolio of acquisitions. Each of the acquisitions has an enormous history, whether it is Pharmacia, Amersham, Biacore or Wave Biotech. These companies had significant presence and now we are trying to be good shepherds of those technologies. GE has a lot to offer in terms of its progress in a couple of areas. One is business operations that are focused on delivering exceptional service and exceptional value to customers and focusing on helping customers become more lean. If you look at our significant presence through the last 20 years, we were one of the first companies to be in India and that way science will benefit from that because we are being pushed not by our competitors but our businesses. If you look at, for instance, our new ECG, the MAC 400, that product was developed in India and now is being produced by the Indian product managers in a facility that is of global standard. We provide world class quality and reliability wherever we operate. How much competition does the company face from other big multinational players in this space? I think I am highly biased with that. We always have our customers in focus and we try to be effective. We have many competitors, most of them are from the US or Europe and some from Japan too. How much does the Indian GE business contributes to the global business? GE Healthcare India is approximately $500million of the global $17 billion. We expect this $500 million to be $800 million in another two years time. What are the other Asia Pacific markets you are looking at? Singapore is an interesting market. There is a lot of government support, a lot of customers are setting up there and it is also given a few tax advantages. The government there is supporting biotech in a big way. GSK, Genentech, Novartis and many other pharma and biopharma companies have a big base there. Australia offers a good market for plasma purification. Our approach for China is to build knowledge services there. Each market is different for us and therefore we serve each one of them in a different way and obviously we are looking at expanding our business in these regions. GE has made a significant number of acquisitions in the last few years for strengthening its base. Are you looking at more acquisitions in the coming years? There is a continuous search for companies. In a few days we will close the Whatman acquisition, which is very significant. We will see what the future holds, but acquisitions are always a possibility. How significant is the Whatman acquisition to the company? Whatman fits within our portfolio and also offers us the ability to move beyond where we are. It is a research and application, filtration company and also spreads beyond life sciences. The company is also into forensics and so it is also pushing us to see other industries. So the future is to push the portfolio of our products to other industries and our ability to strengthen its significance in life sciences. Jahanara Parveen   ]]> <![CDATA[Automation for bird flu testing]]> https://biospectrumindia.com/news/95/7731/automation-for-bird-flu-testing.html https://biospectrumindia.com/news/95/7731/automation-for-bird-flu-testing.html Thu, 05 Jun 2008 09:17:00 +0530 New Page 1 Automation for bird flu testing BioTek Instruments, a leader in microplate instrumentation technology, conducted a case study of a poultry lab in the US. This particular lab, receives a very high volume of poultry samples to be tested for avian influenza and, with BioTek's help, switched to an automated system. BioSpectrum details the process, the lab's problems, and the solution that they're now very happy with. Avian Influenza (AI, also known as "bird flu") Type A virus is classified into two forms â€“ low pathogenic and highly pathogenic. The low pathogenic form manifests with mild symptoms, but there is a risk that the virus can mutate into the highly pathogenic form. This highly pathogenic form of AI Type A, whether introduced from an outside source or mutated from the low pathogenic version, can spread rapidly through poultry flocks, with mortality rates close to 100 percent within two days of exposure. And although many media reports focus on the potential for this virus to cross the species barrier and infect humans on a pandemic scale, a more immediate threat remains for the livelihood of the poultry industry itself. If even one bird in a flock tests positive, the entire flock of 10,000 to 20,000 birds must be destroyed, resulting in thousands and even millions of dollars of lost revenue. Prior to the large-scale Asian outbreaks starting in 1997, routine testing for Avian Influenza (AI) virus by many US livestock serology laboratories was limited to baby chicks and fertile hatching eggs destined for export outside of the US. Currently, AI testing is now mandatory for exported meat, eggs and chicks, and although not required by the United States Department of Agriculture (USDA) or the federal-state-industry cooperation program NPIP (National Poultry Improvement Plan), many poultry farms now choose to test their domestic poultry flocks. Testing is based on a 95 percent confidence interval for each flock. The impact on local government-controlled livestock serology laboratories has been immediate. One of the top poultry-producing states in the US saw a four-fold increase in samples at its peak, with up to 20,000 samples per month sent to their government-run livestock and poultry serology laboratory. Although the lab requested to remain confidential, it currently averages 10,000 AI poultry samples per month according to serology supervisor, Dr Linda Nagin (name changed on request); equivalent to 75 percent of the overall animal testing performed in the serology laboratory. Several AI virus test methods are available including ELISA, PCR, and a highly sensitive but time-consuming agar gel immunodiffusion test. In Dr Nagin's serology lab, poultry serum samples are tested by certified laboratory personnel using a USDA-approved ELISA test method from IDEXX Laboratories. Previously, this test method was performed manually using multi-channel pipettes, with approximately 2 hours to completion for each microplate. To keep up with the increased throughput, Dr Nagin acknowledged that she needed an automated system. "With limited personnel resources, a small laboratory, and potential changes to government criteria, we needed to organize our tests instead of reacting to them," noted Dr Nagin. "We needed new equipment with true multi-tasking abilities." With the decision to move into automated and robotic systems, Dr Nagin's requirements were very specific. Flexibility was the highest priority. The landscape of livestock and general animal disease threats is ever-changing, and to best react to these changes, the system needed to be easily retooled for future tests. As a result, Dr Nagin only considered component systems and excluded all-inclusive systems. The second requirement was that of space. The crowded laboratory of approximately 800 sft housed large equipment, desks and workbenches along with four full-time and two part-time technicians. Space was at a premium, so she wanted to get the most functionality from the system in the smallest amount of space possible. Cost was the final requirement. Many of the robotic systems that Dr Nagin considered lacked the price-to-feature ratio that she was looking for, and when looking at automated non-robotic systems, no one had the whole package. With her selection criteria in mind, Dr Nagin contacted BioTek Instruments for more information on their products. According to Dr Nagin, "While meeting with the BioTek representative, we were able to map out the complete system on our dry-erase board. At every step in our process, BioTek had the tools to meet our needs." The complete system included one Precision XS microplate sample processor, one ELx405 washer, three MicroFill dispensers, one PowerWave spectrophotometer, one BioStack Twister II microplate handler and one LPX44 microplate hotel from LiCONic. Satisfied with the cost, space requirements, modularity and versatility, the BioTek system was approved by Dr Nagin as well as the laboratory director, chief financial officer and agency director; and purchased using a federal grant from the USDA. BioTek worked closely with a third party to create specialized tables for the microplate system with the smallest footprint possible while still retaining the best functionality for specific processes and flexibility to use the components individually. After complete assembly and an initial round of testing at the factory, the entire system was installed at the state-run livestock and poultry serology lab, and adjustments were made to further customize the automation setup. All assay and scheduling parameters were programmed into the system's software according to Dr Nagin's AI test protocol. As the test parameters did not change, the time to completion was not reduced, but active labor time was dramatically shortened so that operators could prepare buffers or run other non-AI assays on other equipment. After adjustments and rigorous testing, including installation qualification, operational qualification and performance qualification, reliability studies were conducted to ensure that the test results would be identical to those achieved via the previous manual methods. Dr Nagin commented, "We expected adjustments and tweaking in the initial testing stages, and BioTek's people provided excellent service and responsiveness." Citing high marks on both service and product quality, the livestock and poultry serology lab has purchased additional equipment from BioTek. Looking to the future, this government laboratory is in the process of becoming a National Animal Health Laboratory Network (NAHLN) laboratory, which encompasses a number of other highly contagious diseases in animals, and they see the BioTek system being utilized further. "The point is, rather than buying a predesigned system and modifying our tests to fit, BioTek created a custom system specific for our needs that can be retasked in the future," noted Dr Nagin several months into use of the BioTek system. "It's like having an extra pair of hands in the lab â€“ it's allowed us to schedule our workload better and frees us to attend to other tasks while the system is running. We're happy to continue our relationship with BioTek."   ]]> <![CDATA[Open source innovation]]> https://biospectrumindia.com/news/95/1984/open-source-innovation.html https://biospectrumindia.com/news/95/1984/open-source-innovation.html Thu, 05 Jun 2008 09:16:00 +0530 New Page 1 Open source innovation CSIR's Open Source Drug Discovery program will harness the collective minds of Indian scientists to be a part of discovery of therapeutics for infectious diseases. Indian drug discovery firms might be attracting a lot of attention for their NCE pipelines and though they might have enjoyed the monopoly in this field, that is soon going to change with the country's foremost research institution, CSIR's new Open Source Drug Discovery project. The project, that is all set to revolutionize the way drugs are discovered, is still at a nascent stage. It aims to throw open the challenges in drug discovery to scientists, researchers and even students in the country's premier educational institutes and research institutions to harness their collective intellectual capital to bring about the country's first drug for tuberculosis as a part of its first phase. This would be followed by other infectious diseases such as malaria and others once the first project has attained success. The project is the brainchild of Dr Samir Brahmachari, director general, CSIR, and has been sanctioned $38 million by the planning commission. Drug discovery, a lengthy process Traditionally drug discovery takes place behind closed doors, veiled and shrouded in secrecy, thus terminating any participation from the academia. Not only is it time-consuming and expensive, but also a high-risk proposition. It begins with basic research, which expands the fundamental understanding of disease pathways and identifies and characterizes new drug candidates. This is followed by developmental research, where researchers test the safety and efficacy of a new drug candidate and determine its metabolism and interaction with the body and with other drugs. Only a fraction of drug candidates proceed beyond basic research and preclinical development to clinical trials - a process that takes many years. Roughly out of 10,000 compounds in basic research, on an average only five enter clinical testing and just one makes it to the market. The open source model Wikipedia defines open source as a development methodology which offers practical accessibility to a product's source (goods and knowledge). The open source model of operation and decision-making allows concurrent input of different agendas, approaches and priorities, and differs from the more closed, centralized models of development. The principles and practices are commonly applied to the development of source code for software that is made available for public collaboration, and it is usually released as open-source software. The human genome project and Linux are other examples where the open source model has found its application. What the Open Source Drug Discovery project is aiming at is more free sharing of information. Optimizing on the popularity and the ease of the Internet, the project aims to have a web-enabled platform that will list the design challenges involved in developing a drug. The various steps involved in the development of the drug shall be broken up into smaller and simpler tasks and scientists, researchers and students would be open to contribute solutions for the same. This might involve information about a new drug target or an algorithm to make a protein bind to a particular site on a cell. After the drug has been developed, the formulation as well as the process of development will be in public domain, accessible by everyone and not just to people who contributed to the development of the drug. Patents will not be given to those solving a particular part of the drug discovery process, hence anyone who has the capability to make the drug can now manufacture it. However, companies who want to reap monetary benefits by modifying the drug and then selling them at exorbitant prices won't be able to do so Collaboration is the key The innovative concept will see global IT firms (Sun Microsystems), researchers, undergraduate students and companies working in tandem. Sun Microsystems is setting up the architecture since they have experience with open source, so they are interacting with the scientists to put up a system in place. Researchers attached to foreign institutions such as The royal Society of UK, Imperial college of London, Medicine Sans frontiers institute will also be involved along with Several CSIR institutes including IGIB (Institute of Genomic and Integrative biology), CDRI, IMTECH Chandigarh, National Institute of Immunology. Many institutes and pharma companies are also showing interest. TCG life sciences and AstraZeneca are a few companies who have expressed interest in the project. To encourage contributors to come up with innovative ideas, there are rewards and incentives as well. For instance, scientists and researchers would be upgraded to gold and platinum memberships from a silver one on the website based on their contributions and the number of credits they accumulate. There will be monetary rewards for students as well for their contributions. The advantage The model has a long term goal of making health affordable to all by reducing the cost of patented drugs especially for chronic diseases requiring long term treatment low. This along with putting up a web enabled open source platform both computational and experimental would further reduce costs. Discovering and bringing one new drug to the market typically costs a pharmaceutical or biotechnology company nearly $900 million and takes an average of 10 to 12 years wherein 5,000-10,000 compounds are screened before a new drug reaches the market. The project also hopes to mitigate the high failure rates that plague drug discovery and development. With open sharing of information, the time taken to find a possible drug for a disease can be reduced to 4-5 years as opposed to a period of 10-12 years. Shalini Gupta   ]]> <![CDATA[Turning CFOs into strategic partners]]> https://biospectrumindia.com/news/95/1433/turning-cfos-into-strategic-partners.html https://biospectrumindia.com/news/95/1433/turning-cfos-into-strategic-partners.html Thu, 05 Jun 2008 08:57:00 +0530 New Page 1 Turning CFOs into strategic partners Paul Bierbusse, business advisory services, global pharmaceutical industry, Ernst & Young Global As a support function, finance has typically been one of the last places within a company targeted for cost reduction efforts. In pharmaceutical companies, finance chiefs have had even more breathing room, thanks to low operating costs and hefty profit margins. But now, owing to price pressures from insurers and government regulators, efficacy issues related to their drugs, and depleted new product pipelines, pharmaceutical chief financial officers (CFOs) are being pushed to reduce the overall cost of their finance organizations while improving the efficiency and effectiveness of their businesses. The trouble is that many of these finance leaders aren't equipped to go beyond a typical review of their cost structure. They know they want expenses to drop as a percentage of revenue, and they are guided by the goal of hitting industry benchmarks. A certain comfort level develops when companies stack themselves up against others in their trade. But if all pharmaceutical companies are equally inefficient, what good are these benchmarks? Many companies still rely on instant-gratification cost-cutting campaigns that help them hit their desired cost reduction target. They opt for the easy course, moving transaction processes such as expense reporting, payments, and other basic accounting procedures to in-house shared services operations or outside the firm to third-party vendors. Since this approach does little to reduce work, this strategy is like squeezing a balloon; no wonder CFOs are surprised to find they have merely pushed costs somewhere else in their business. CFOs in the pharmaceutical industry are discovering that their departments' costs can't be managed in isolation from value. Differentiating services from both a cost and value perspective has helped them identify those tasks that are strategically distinctive to their enterprise versus those that are simply operationally effective. That meaningful vetting has enabled some of them to transition from being their companies' scorekeepers to helping shape the play as business partners with seats at the strategy table. Prioritizing responsibilities Transaction processing is the least valuable task in terms of return on effort, followed by financial stewardship and compliance. Reporting and analysis sit on a higher value stage, topped only by strategic insight. A brief examination of each level of value helps to frame the existing opportunities. For example, in transaction processing, the quick hits have come from outsourcing basic accounting tasks such as payroll or setting up standardized practices across the company to handle billing and procurement. Forward-thinking companies are now taking the next step: trying to redeploy more difficult tasks that involve customers, like order-to-cash (the process that drives the steps of a transaction from the time the order is placed to when the account receivable is collected). For example, while businesses wish to retain the customer interface afforded through direct salesperson contact, the accounting activities related to invoicing generation and presentation, as well as cash collection, can easily be standardized and centralized into a shared service center. This shift can achieve significant efficiencies and, often, improve the effectiveness and quality of the underlying process. In stewardship and compliance, US-listed firms have built up massive organizations in recent years to meet Sarbanes- Oxley and other regulatory requirements. But by adding layers of employees who serve only to make sure the company doesn't do anything wrong, they have effectively handcuffed their business. As one CFO puts it, "We've got checkers checking the checkers' checkers." Therefore, the CFO is challenged to create a controls environment focused on cost-effective management of risk. Tools to tame data Finance chiefs are right to be worried about the legal and reputational cost of noncompliance, but they aren't taking advantage of statistical modeling tools that could help them establish more cost-effective controls. Organizations that have recently deployed standardized business systems could install enhancements that can screen for red flags, obviating the need for manually reviewing each transaction and significantly lowering the cost of compliance. When it comes to reporting and analysis, it's clear that many companies don't understand the cost or efficiency of information. A supervisor may ask an employee a question about the profitability of a product in a certain market, and the employee sets off on a lengthy mission to procure the data, build a report, and conduct the analysis required to come up with the answer. The supervisor might have been satisfied with just a degree-of- magnitude answer yet receives a report specific to the fourth decimal place and supported by over 50 slides. Finance operations tend to build large infrastructures to obtain information that may not always be needed or that may overwhelm decision-makers. As a result, hundreds of employees might be dedicated to reconciling and verifying information contained in disparate systems. Often, the same analysis is also being conducted by one or two separate divisions. Finance transformation is successful when it puts in place systems that produce this information in a timely, accurate, and relevant manner. When these answers are readily available, finance organizations can focus on value-added analysis. Functions with the highest value within finance organizations are those that provide strategic insight and transform the image of the CFO from that of a bean counter to that of a stakeholder in the company's future. If you look at what CFOs are engaged in at the world's leading-edge companies, they're elbow-to-elbow with their chief operating officers, figuring out what companies to buy, what new products to develop, and how they want to communicate with their investors. It's one thing to set and maintain a budget for the marketing unit, for instance, and quite another to bring the rigor of finance to the operation, devising ways to measure the worth of marketing investments and make them more efficient. Sadly, few CFOs spend a significant part of their day concentrating on these crucial topics. In fact, in a recent Ernst & Young survey, conducted by the Economist Intelligence Unit, 56 percent of pharmaceutical executives felt that CFOs spent the least amount of time acting as business partners, occupied instead with lower-value activities. Think back to that pyramid. The first three tasks -transaction processing, stewardship and compliance, reporting and analysis - all tell you what happened in the past. Strategic insight is about helping the company achieve what it wants for the future. Outlook Finance leaders in the pharmaceutical industry would do well to think to the future and start focusing on strategic cost savings that increase the value of the CFO function. Last year, there were a record 2,302 job changes by CFOs, according to CFO.com. The reasons for such job turnover, according to most of those surveyed, were regulatory reporting burdens and an increase in board and stakeholder demands. Those challenges are unlikely to change. The only way to overcome them is by prioritizing your goals and aligning your cost structures to match.     ]]> <![CDATA[The changing paradigm]]> https://biospectrumindia.com/news/95/2758/the-changing-paradigm.html https://biospectrumindia.com/news/95/2758/the-changing-paradigm.html Wed, 04 Jun 2008 13:37:00 +0530 New Page 1 The changing paradigm The pharma industry is changing from its traditional ways of investing in research and conducting business. Diminishing returns on R&D investments is a growing concern for the global pharmaceutical industry. As an illustration of this point, the combined spending on drug discovery-research for the major North American pharmaceutical firms rose from slightly over $15 billion in 1995 to just under $45 billion in 2006; however, the new drug approvals every year fell from over 50 to just over 20 in the same period. This trend is forcing the industry to change from its traditional ways of investing in research and conducting business. First, placing big bets on a few small molecules, in the hope that these would become blockbuster drugs that would be the primary prop for the company, would no longer be a sustainable model. It is becoming increasingly clear that "big" drugs like say, Lipitor, the cholesterol drug made by Pfizer, which has been selling annually for well over $10 billion, are becoming almost impossible to discover. An analysis of recent drug launches suggest that the pipeline is shifting towards targeted therapies, though drugs for the general management of chronic diseases like high blood pressure and diabetes may still be important. Another notable shift in focus is from treatment to prevention. According to a WHO report, only 3 percent of healthcare spending in wealthy countries is used for prevention, even though 80 percent of heart diseases, stroke and diabetes and 40 percent of cancer could be prevented. Preventive medicine offers the next growth area for pharma companies with vase opportunities in the realms of health management, wellness programs, compliance monitoring, vaccination and other value-added services. The market for just pure vaccines and combination vaccines is estimated to grow as much as $42 billion by 2015. Indian companies, which have proven strengths in this area, are well placed to capitalize on this opportunity. Technology will be the other big driver of change in pharmaceutical innovation. The unraveling of the human genome sequence has opened up new opportunities for molecular science in health care and novel approaches in identifying drug targets. The promise of gene-based diagnostics for several physiological and pathological conditions is getting increasingly realized. Personalized medicine will become the order of the day. The big pharma companies can no longer bank on the "cash-cows" in their product portfolios for sustaining their top and bottom lines. Drugs are fast going out of patents, and new innovations are not keeping pace for keeping the value of the company's Intellectual property from diminishing. It has been estimated that since 2001, the average annual value erosion to pharmaceutical firms, through expiry of patents, is over $15 billion. We are now in a phase of particularly accelerated intellectual property attrition; in the next 4 years, over $150 billion of global drug sales will stand exposed to generic competition. This could be a windfall for the Indian drug manufacturers, who have already emerged as leaders in the generic drug business. In recent years, cutting costs for new drug development has been the primary focus in the R&D strategies for pharma companies. Rapidly emerging diseases like the avian flu also necessitate the need for shortening the drug development life cycle. Both these objectives can be eminently addressed by discovering new uses for existing drugs. As approved drugs have known pharmacokinetics and safety profiles, any newly identified use can be rapidly evaluated in phase II clinical trials, thus bypassing almost 40 percent of the overall drug development cost and saving considerable time in bringing the drug (for a new use) to the market. According to a recent commentary in Nature, there are approximately 9,990 drugs known to clinical medicine. Of these, 8850 are unique and are worth screening for novel therapeutic uses. However, the availability of a comprehensive collection of these molecules and existing patent restrictions could be challenges to this approach. Another means of reducing drug development costs is through outsourcing of discovery research to low-cost destinations like India. A study by Technomark, a UK-based organization that tracks the global market for research outsourcing, the pharmaceutical contract research market, which is currently just under $15 billion is growing at 15 percent per annum, twice the rate at which the pharma business is growing. India is today an attractive destination primarily because of the lower people cost; however, this situation is fast changing with rising salary levels for qualified scientists. The way things are developing, it appears that the window for cost arbitrage would remain open only for the next 10 years or less. We would do well to take full advantage of this short-term opportunity by improving the intellectual property protection regime and implementing some quick-fix approaches to generate more quality man power for technology management. The latter could be achieved through short-term specialized courses like a finishing school for graduates and post-graduates in the country. Attracting the well-trained Indian talent from abroad is another option; the looming economic recession in the US could be a spur for this "home-coming". Indian firms should open-up and provide the right working conditions for this to happen at an accelerated pace. The global pharma market is predicted to be more than double in value at $1.3 trillion by 2020, according to a recent Pricewaterhouse Coopers study. India and China together, which will have almost 40 percent of the world's population by then, would also account for a major chunk of this market. The Indian pharmaceutical industry is well placed to capitalize on the changing paradigm in drug discovery and could well spearhead the transformation in the global health care business. Dr KK Narayanan   ]]> <![CDATA[Malaria revisited]]> https://biospectrumindia.com/news/95/1997/malaria-revisited.html https://biospectrumindia.com/news/95/1997/malaria-revisited.html Wed, 04 Jun 2008 13:33:00 +0530 New Page 1 Malaria revisited New tools for vector control will be essential to combat an old disease like malaria. The United Nations has designated the 25th of April of every year as the day for the entire world to focus attention on malaria, a disease that is reputed to kill about a million people all over the world every year. The theme of this year's Malaria Day was "Malaria: a disease without borders". The day was celebrated with much fanfare, but with a feeling of guilt among global health leaders. Major health bodies like the World Health Organization (WHO) and the Global Fund to Fight AIDS, Tuberculosis and Malaria are now joined by the Roll Back Malaria (RBM), McKinsey and the Boston Consulting Group, Bill and Melinda Gates Foundation and others to lament for all the missed opportunities to tackle the disease and eradicate it. President Bush, despite his poor record in Iraq, has pledged $1.2 billion in a high-profile summit on malaria eradication attended by Exxon Mobil and other corporate people. Each year as many as 500 million people catch malaria and more than a million die. Sri Lanka, which once eradicated malaria, now has over 10,000 deaths due to malaria every year. In India there are no authentic records to show the mortality trends due to malaria. This is one public health disease, which has simple solution but complex management problems of recurring costs and emerging contradictory research findings from time to time. Despite Bill Gates Foundation's generous monetary aid to fight malaria and other diseases to the tune of $8 billion, it has created "ego" problems to people like Dr Arata Kochi, head of malaria program in WHO, who said that "Gates Foundation has negative influence on research into killer diseases like malaria". Dr Kochi feels the Bill Gates Foundation bets too much on a particular treatment such as artemisinin derivative-based combination therapy (ACT). Although ACT does work better than older therapies, there are signs that drug-resistant strains of the disease are emerging and in the words of Dr Kochi, "what happens if under the Gates influence, malaria researchers put all the eggs in that one basket?" (The Economist, February 23, 2008). But there are some like Dr Yamada of Gates Foundation who feel that the Gates Foundation is open to all new research ideas and although ACT therapies are supported by Gates Foundation, they also support the use of bed nets and vaccines. But the world's premier health body, the WHO, is worried about the new "power centers" in healthcare like the Bill Gates Foundation, which may reduce the relevance and authority of the WHO. This is the trouble with UN bureaucracy and they should support any intervention which is affordable and manageable. Recently the Gates Foundation has given $100 million to the University of Washington to evaluate health treatments and monitor national health systems â€“ jobs supposed to be done by the UN agency like the WHO. Luckily for the good of the world's malaria community, particularly in the African sub-continent, a clear consensus is emerging which supports treatment strategy involving bed nets impregnated with long lasting insecticides, indoor spraying of insecticides and pills using ACT therapies . Half a century ago, the WHO led a campaign for the total eradication of malaria. Many countries made great progress in reducing deaths due to malaria. But the recurring costs are high in the malaria eradication program. Mckinsey has now calculated that once the five-year spending plan for malaria eradication is complete, the recurring expenditure has to be in the range of $1.8 billion a year for an indefinite period. Which African country can afford this huge budget? Hence a vaccine against malaria has to be discovered soon so that like small pox, it can be eradicated once and for all. Dr Manu N Kulkarni Professor Emeritus, Siddaganga Institute of Technology, Tumkur & Member, National Population Commission manukulkarni@yahoo.com   ]]> <![CDATA["We intend to be a global player in early clinical development space"]]> https://biospectrumindia.com/news/95/2746/we-intend-to-be-a-global-player-in-early-clinical-development-space.html https://biospectrumindia.com/news/95/2746/we-intend-to-be-a-global-player-in-early-clinical-development-space.html Wed, 04 Jun 2008 13:29:00 +0530 New Page 1 "We intend to be a global player in early clinical development space" -Binoy Gardi, co-group managing director and co-founder and Apurva Shah, co-group managing director and founder, Veeda Clinical Research Ahmedabad-based Veeda Clinical Research has made four acquisitions in the last two years and continues to follow the idea of acquisitions to strengthen and build its capabilities and enhance its global presence. In an interview with BioSpectrum, Binoy Gardi, co-group managing director and co-founder and Apurva Shah, co-group managing director and founder of Veeda Clinical Research spell out Veeda's strategy, vision and plans. Excerpts: How have the European acquisitions helped Veeda CR in its positioning? We were the first ones to acquire a phase1 unit outside India. This again was a bold step for a company who had only been in a business in India for three months. Once again this highlights our commitment and belief in our vision and our plan. Buying companies is sometimes easy, but integrating companies in terms of SOPs (standard operating procedures) and cultures has not been an easy exercise. Indian companies who decide to follow this acquisition strategy will need to focus on this aspect if they want to avoid failing. Any successful business is not about just having world class infrastructure, you also need world class people. At Veeda we have managed to attract truly a world class management team comprising both Indians and Westerners. What are the various challenges that you face in the CRO industry? With this high-paced growth, there are several challenges facing us. The biggest challenge is the lack of availability of qualified people to meet the demands of growth. As a result of this scarcity of people, companies are constantly trying to poach one another's staff resulting in people constantly jumping from job to job and demanding higher salaries and higher positions. Therefore, attracting and retaining staff is probably the biggest problem faced in today's Indian CRO market. The industry attrition rate averages 30 percent. Having such a large attrition rate is not looked upon favorably by sponsors, especially international sponsors. At Veeda we have managed to keep our attrition rate at about four percent and this has been one the biggest factors which has allowed us to grow at such a fast pace. What is Veeda's current global positioning and strategy? We do not want to compete with Quintiles and Covance as they are a full service CRO. We are very much focused on early clinical development only. We intend to be a global player in the early clinical development space. At present we have 225 beds and in the next 12 months this number will be more than double. Together with our strategic alliance with Advinus, we can offer many biotechs and small to mid-sized pharmaceutical companies an option to take their molecule from pre-clinical all the way to proof-of-concept by leveraging the advantages of India without compromising on quality. Considering the opportunities in India, the company has taken up several initiatives. What are the activities you are undertaking in other regions? In order to complete our model we will be acquiring another phase 1 unit in the US within the next 12 months. It is only after having a physical presence in the US can we say that we are truly global. We are building a new facility in Ahmedabad and we intend to have a number of more phase 1 units in other parts of the country. We are already the first CRO in the country to open a unit at the Muljibhai Patel Renal Hospital in Nadiad. What has been your investment so far in India and other regions? It has been over Rs 100 crore. What are the new markets you are looking at? As mentioned earlier, we are looking at acquiring another phase I unit in the US within the next 12 months. Jahanara Parveen   ]]> <![CDATA[Veeda Clinical Research on an acquisition spree]]> https://biospectrumindia.com/news/95/5663/veeda-clinical-research-on-an-acquisition-spree.html https://biospectrumindia.com/news/95/5663/veeda-clinical-research-on-an-acquisition-spree.html Wed, 04 Jun 2008 13:13:00 +0530 New Page 1 Veeda Clinical Research on an acquisition spree Veeda has been growing at a rate of 70 percent and it aims to achieve a turnover of Rs 325 crore in the next three years. For this, the company is on a mission of strengthening its global presence and expanding its operations through acquisitions. Ahmedabad-based Veeda Clinical Research, with presence in Europe, India and the US, is set to expand its operations further by acquiring two overseas companies in the next few months. The company is in the process of finalizing the acquisitions and is therefore reluctant to divulge names. In the last two years, Veeda has acquired four CROs in Europe and also set up an office in the US. The planned acquisitions are part of company's global expansion strategy through organic and inorganic ways to conduct clinical trials across geographical locations. Veeda last year completed the take-over of a phase 1 clinical research unit in Gorlitz, Germany. The addition of the unit, Veeda's second acquisition in Europe, is added to the existing units in Plymouth, the UK and Brussels and gives Veeda a broad base for early clinical development in Europe. Earlier in 2007, Veeda had completed the acquisition of DICE, a CRO based in Belgium. The acquisition of DICE, a highly specialized CRO with 15 years of experience in data management, biostatistics, statistical analysis and medical writing for clinical trials, enabled Veeda to offer the biopharmaceutical market a greater depth of scientific expertise, delivered from sites in the UK, mainland Europe and the Indian sub continent. With the acquisition of DICE, Veeda CR is now well placed to deliver cost-effective, timely research solutions to the pharmaceutical and biotechnology industries worldwide. With state-of-the-art phase I facilities in Plymouth, Ahmedabad and Gorlitz, fully accredited GLP laboratories, an established biometrics team in Belgium and Mumbai and a respected pre-clinical partner, Veeda CR is capable of handling all types of phase I and BA/BE studies from technically complex trials to the more routine PK studies. Veeda CR's primary focus is to offer clients an integrated, cost-effective early clinical development service delivered with commitment to quality. Having collectively conducted well over 500 phase I studies, from first-in-man to large scale bioequivalence/bioavailability comparator studies, Veeda CR works in partnership with several national and multinational pharma majors. Veeda CR has dedicated clinical pathology, bioanalysis, biomarker and immunogenicity laboratory services which are GLP accredited and has access to an extensive database of volunteers. Veeda CR can locate the right trial in the right place, with the UK unit offering specialized, highly demanding studies and the Indian unit offering vast populations, excellent turnaround times and considerable economies. The company has its strong presence in leading therapeutic areas such as dialectological, anesthetics, cardiovascular and central nervous system (CNS). About 20-25 phase I studies for various therapeutic areas are going on and results are expected very soon. The company offers its services to 20-30 pharmaceutical companies, including 10-12 are multinational giants. Strategy Acquisitions have been Veeda's key growth strategy to expand its presence and accelerate growth both in India and other regions. The company has made four overseas acquisitions in the last three years. These acquisitions indicate that Veeda is focusing on Europe in a very big way and the company aims to bring many global projects. It also plans to increase the head count in India and other regions in the near future. The aggressive growth strategy, involving global acquisitions, helps Veeda in terms of proximity to its clients and provides access to their preclinical and pharmaceutical development capabilities and a world-class development team. "We are very much focused on early clinical development only. We intend to be a global player in this space. Together with our strategic alliance with Advinus, we can offer many biotech and small to mid-sized pharmaceutical companies an option to take their molecule from preclinical all the way to proof-of-concept by leveraging the advantages of India without compromising on the quality", said Binoy Gardi, co-group managing director, Veeda CR. Other major developments A series of developments have taken place in Veeda since its inception. The company recently launched a global oncology CRO to provide oncology clinical research services internationally for the pharmaceutical and biotech industries. Apurva Shah, co-group managing director, Veeda CR, commented, "A key strategy that we are implementing will be our access to the oncology patient population through our unique exclusive relationships with oncology hospitals in India as well as unique relationships with oncology hospitals in Eastern Europe. In addition, our US organization has worked with virtually every major oncology investigational site. With these relationships and the rapid ability to open sites, we will be able to meet the critical accrual requirements that our sponsors are establishing to accelerate the rate of drug development". In another recent development, Veeda Oncology completed the acquisition of Biologie et Industrie (B&I), an oncology CRO founded in 1984, based in Paris, France. The acquisition of B&I, with over 20 years of oncology CRO experience, significantly compliments Veeda Oncology's capability within mainland Europe. Commenting on the acquisition, Binoy Gardi said, "The acquisition of B&I is one significant pillar that we are adding to our global oncology presence within the oncology CRO marketplace". Earlier this year Veeda had opened its new clinical pharmacology unit at Muljibhai Patel Urological Hospital (MPUH), Nadiad, Gujarat, a premier institution providing health services in urology and nephrology including kidney transplantation. Veeda will conduct phase I /II clinical studies in renal impaired patients at the unit. With the establishment of this unit, Veeda CR now has access to the experienced manpower of the hospital as well as the facilities available like kidney dialysis machines, pathology laboratory, X-rays and CT scan. Ongoing projects Veeda Clinical Research has also formally commenced a number of initiatives resulting in the formation of an experimental medicine group within the infrastructure of the CRO. Traditionally, Indian phase I units have concentrated on bioequivalence and bioavailability work and most recently, Veeda has led the way in establishing first-into-man facilities and formal phase I and human clinical pharmacology across the group and especially in India. As a result of plans formed with a number of multi-national pharma companies, Veeda established within the phase I group, a small multi-functional team working on experimental medicine studies. Recently the group working in Plymouth completed a very sophisticated first-into-man study of a novel intravenous anesthetic. At the same time, in India, the team developed methods for the study of the microcirculation in the leg muscles of diabetics and normal subjects in advance of a new drug being developed by a major Indian pharmaceutical company for whom the Veeda Group is conducting all the early clinical development studies from first-into-man onwards. The studies are being conducted across the group sites, utilizing the best facilities irrespective of the geography. In addition, the company's biomarker facility in the Oxford Science Park has set new standards for its ability to set up specific methods for new markers of disease and explore their significance. At the moment, the teams are just preparing to conduct some studies in diabetology, which takes the established method of glucose clamping to a new level, and clamping other metabolic compounds such as lactate and pyruvate. Apart from this, plans within the group are afoot to open a pharmacogenetics laboratory at the Ahmedabad facility in collaboration with the University of Singapore. In a quite different area, the Ahmedabad teams are preparing to work with a US-based team to examine some basic science relating to Alzheimer's disease and models of this condition, which can be simulated in normal individuals. Commenting on these initiatives, Apurva Shah said, "The recent developments in Veeda move the company to a quite different plane from the level of the normal CRO. For staff, the excitement of ground-breaking work will provide much more stimulation and job satisfaction than the day-to-day grind of the process-driven CRO environment". Growth plans Veeda is continuing to expand its capabilities and will be doubling the bed space capacity in the next 12 months in India. Currently, the company has a capacity of 225 beds in four temperature-controlled clinical investigation areas in the country. Veeda aims to double this capacity in the next 12 months. Veeda, with state-of-the-art phase I facilities in the UK, India and Germany, is planning to invest over Rs 100 crore to achieve organic and inorganic growth in the next 12 months. The company is building a new facility in Ahmedabad and also intends to have a number of more phase 1 units in other parts of the country. Jahanara Parveen   ]]> <![CDATA["VLife pursues a hybrid approach to growth"]]> https://biospectrumindia.com/news/95/1126/vlife-pursues-a-hybrid-approach-to-growth.html https://biospectrumindia.com/news/95/1126/vlife-pursues-a-hybrid-approach-to-growth.html Wed, 04 Jun 2008 13:00:00 +0530 New Page 1 "VLife pursues a hybrid approach to growth" -Supreet Deshpande, CEO, VLife Technologies In a freewheeling interview, Supreet Deshpande, CEO of VLife Technologies, spells out his company's business strategies, its global plans, the challenges and apprehensions in entering these markets. Excerpts: Your company has adopted both organic and inorganic growth models? How have these models helped the company? The organic model definitely creates a solid foundation for a company without which it is impossible to pursue inorganic growth model. With this model alone, the rate of growth however is relatively slower, especially if the domestic market is yet to mature. Our focus on the domestic market so far has resulted in better awareness of cutting edge technologies and benefits thereof, opening up a market which has significant potential. In tandem, the company requires to develop new markets for which local presence is critical, especially for the domain we are in. Creating local presence, building a sales organization, creating brand awareness are time consuming efforts. For such markets, the inorganic growth model helps cut down time for achieving entry and rapid consolidation. It is for this reason that VLife pursues a hybrid approach to growth. As part of its growth strategy, VLife Sciences has gone into acquisitions in the US and the European Union? What were the reasons for the acquisitions and what have been the benefits? The US and Europe constitute a significant share of the market for the technologies and products like ours. These markets are sizeable, mature, more informed and consistent over the years. Entry into the US and Europe is significantly resource and time consuming for a new company like VLife in spite of having significant competitive edge, because these are brand-driven markets. To overcome these challenges in these markets, VLife has short-listed three acquisition opportunities. We expect to complete and streamline at least one acquisition during the current fiscal. This acquisition will significantly enhance the market reach for VLife's technologies whose competitive edge is well established. What were the challenges and apprehensions while entering such markets considering that they are matured and regulated? Regulated markets have no bearing on the licensing of software technologies and product like the way it impacts the licensing of pharmaceutical pipeline candidates. These markets due to their maturity bring both opportunity and challenges. The challenges come from the fact that all our competitors are mostly local with well entrenched brands and decades of presence. On the other hand, significant opportunity exists because these markets are better positioned to appreciate the cutting edge technologies due to their long history of using such technologies. Your business model is basically that of leveraging and licensing? How sustainable is it for your company? VLife has developed cutting edge platform technology for drug and molecular design, visualization. While almost all companies need technologies like ours, their needs differ. The companies, who have elaborate research programs, require these technologies for a long period and hence prefer licensing. While the others require them either for short period or lack specialized resources to use technology in-house. To such companies, we leverage technologies in-house to provide special purpose research services. This model is perfectly sustainable because it is driven by market requirements, which are logical and realistic. Why has there been a licensing of software products on an aggressive basis just in the US and EU while there are other markets which are more lucrative? The US and EU have a long history of successfully building IP based businesses, which essentially require sustainable in-house research programs. Hence, there is both entrepreneurial and investor confidence in pursuing businesses which are research driven. Hence, licensing of technologies in these markets is more aggressive. Will we be seeing a few more niche technologies for biotech? Definitely from VLife's stable as we have matured three critical technologies over the last 16 months that are being converted into product form. These technologies have been assiduously benchmarked against existing technologies for the purpose and found to be distinctly favorable both in terms of accuracy of prediction and time required for their application like SCOPE and GRIP. We believe that these technologies will significantly change the way scientists have been doing their research so far. Nayantara Som   ]]> <![CDATA[Human antibody to dominate next wave of approvals]]> https://biospectrumindia.com/news/95/2276/human-antibody-to-dominate-next-wave-of-approvals.html https://biospectrumindia.com/news/95/2276/human-antibody-to-dominate-next-wave-of-approvals.html Wed, 04 Jun 2008 12:13:00 +0530 New Page 1 Human antibody to dominate next wave of approvals The current mAbs market is about $20 billion and will witness a two-fold increase in the next four-five years. The successful launch of Genentech's Rituxan in 1997 has not only opened up the market for monoclonal antibodies (mAbs), but also inspired many players (both big pharmas and small biotech companies) to make this profitable, low risk investment. Since 2001, the mAb-based therapies have been posting the fastest growth within the protein therapeutics market. The mAbs market now classified as one of the most lucrative sectors of the pharmaceutical industry, registered a 37 percent growth during 2001-02 touching $5.4 billion. The market continued to witness an upward trend with an exceptional 48.1 percent growth between 2003-2004 and was estimated at $10.3 billion in 2004. The antibodies market, in 2005, was valued at about $14 billion, accounting for over 24 percent of the total protein therapeutics market. This share increased substantially since 2001, when it barely surpassed 13 percent. According to the industry estimates, the current mAbs market is about $20 billion and will witness a two-fold increase in the next four-five years. This growth will continue in the coming years, boosted by a number of new mAbs on the market, new indications for successful medications, and their ability to treat conditions and diseases. It has the potential to increase in value over the years and reach $30 billion in 2010, driven by technological evolution. It is forecasted that mAbs will act as the key growth segment of the prescription pharmaceutical market. According to a Datamonitor report, the mAb revenues are projected to grow at a compound annual growth rate of 14.2 percent over the period 2006-12, versus 2.2 percent for the overall market over the period 2006-12. Companies stake a claim Genentech, Biogen Idec, MedImmune, Johnson & Johnson and Abbott hold a major share in the global mAb market. Datamonitor report says the number of companies with direct sales of monoclonal antibodies is expected to increase from 17 in 2004 to 36 by 2010, as new products and companies flood the market. It also forecasts that by 2012 a number of additional players will have significantly enhanced their presence in the mAb segment, with four companies-Biogen Idec, Amgen, Novartis and UCB Pharma each generating mAb sales in excess of $1 billion. Over 150 companies are currently working on more than 400 antibody-based drugs that are in development for the treatment of cancer (solid tumors, non-Hodgkin's lymphoma), immune and inflammatory diseases, transplant rejection, rheumatoid arthritis, Crohn's disease, psoriasis, lupus, multiple sclerosis, asthma, age-related macular degeneration, HIV and Alzheimer's disease. When asked how many companies are working on monoclonal antibodies, Dr David R Buckler, director, Alliance Research and Discovery Research, Dyax Corporation, US, said, "Many companies that are involved in drug discovery are working on monoclonal antibodies. Even the big pharmas that have traditionally been the small molecule companies seemed to be either acquiring or developing own internal capabilities to encompass biologics as well. Monoclonals are probably one of the biggest and interesting subcategory of biologics". APAC region follows the mAb trend Leveraging on the strengths and opportunities, about 40 companies in the Asia Pacific region are focusing on product development from mAbs. Companies in Australia, Japan, Korea, India and China, doing research and development, are entering into deals with major pharma companies to catch up the pace of development and for the early entry into the market. In some cases it may be other way also. One such example is the merger between Peptech and Evogenix from Australia. This has created one of the leading companies in antibody development in the Asia Pacific region and certainly the largest antibody/ protein engineering facility in the southern hemisphere. The new entity is named Arana Therapeutics. The industry, in the last couple of years, saw as many as 24 deals (both technology and product) related to mAbs. In 2007, the region had some five-six deals. Japan's Astellas has forged a deal to buy Santa Monica, CA-based Agensys for $387 million plus up to $150 million more in milestones. The deal gives Astellas new antibody technology for combating cancer. Agensys has a phase Ib trial underway for one antibody plus several more preclinical candidates. Japanese drug maker Daiichi Sankyo received exclusive rights from the US biotechnology company Amgen to develop and commercialize an antibody to treat osteoporosis and other bone diseases in Japan. Amgen has also entered an exclusive licensing agreement to develop and commercialize Kyowa Hakko Kogyo's humanized monoclonal antibody KW-0761 worldwide, except in Japan, Korea, China and Taiwan, where Kyowa Hakko will retain development and commercialization rights. On technology front, Protagen AG, a leading provider of products, services and software solutions for protein research announced its partnership with the Center for Applied Proteomics (ZAP), Dortmund, Schunde Kangdi Antibody Biotech, Foshan, China and the Beijing Proteome Research Center (Beijing PRC) to develop antibodies against liver proteins. "The Asia Pacific region offers many advantages for the development of antibodies. The antibody development is driven by large corporations, leveraging available revenues to make foray in the antibody space. The lower development costs in the region on the clinical side allow for cheaper access to the same billion dollar markets", said Dr John Chiplin, CEO, Arana Therapeutics, Australia. Move to humanized antibody Beginning with murine anitbody in 1986 (Johnson& Johnson's product Muromonabâ€“CD3), the companies are focusing more towards humanized and human antibody. The approvals, so far, were moreso of chimeric and humanized. However, human antibody products will dominate the next wave of approvals. As of 2007, there were 22, the US FDA has approved therapeutic mAbs, comprising four different types, three murine, five chimeric, 11 humanized and three human. The development focus of the industry is moving away from murine and chimeric antibodies, to humanized and, in particular, fully human technologies. The market is expected to continue to evolve as antibody engineering capabilities advance further, including more efficient manufacturing and alternative delivery methods, broadening the commercial viability of antibodies treatments in a wider range of diseases. A wave of fully human products is expected to launch from 2007 onwards, accounting for 12 of the 20 launches between 2007 and 2010, says a report from BioSeeker. Sharing his views on the number of mAbs that will hit the market in next one or two years, Dr Michael Steward, senior scientist, Biopharm CEDD, Domantis, Cambridge, US, said "It is very difficult to say. The attrition rate for monoclonals is not as high as small molecules drugs. I expect to see probably doubling of monoclonals in the market by the middle of next decade. I would expect to see an annual approval rate of may be half-a-dozen a year". The industry has the potential to double the number of approved mAbs, and also double the size of global mAbs market, as antibodies currently face no prospect of generic competition. To achieve this, the industry needs to continue to develop with technology integration and market expansion. The market success will depend on strategies targeting shorter development times, higher success rates, innovative molecular engineering, robust intellectual property protection and the development of cost-effective manufacturing.   Narayan Kulkarni   ]]> <![CDATA[SBIRI-funded companies taking wings]]> https://biospectrumindia.com/news/95/2274/sbiri-funded-companies-taking-wings.html https://biospectrumindia.com/news/95/2274/sbiri-funded-companies-taking-wings.html Wed, 04 Jun 2008 12:05:00 +0530 New Page 1 SBIRI-funded companies taking wings The Small Business Innovation Research Initiative (SBIRI) was launched by the DBT two years ago and the success is very much evident from the fact that today it has 37 projects up and running under its umbrella. BioSpectrum takes a look at few companies boosted by the SBIRI scheme. Indian biotech companies may well be on their way to becoming the next global leaders in biotechnology, but if the spirit of innovation has to be fostered in the country, it is not only large companies, but small business units as well that have to be given a technological thrust. It was with these objectives in mind that the department of biotechnology (DBT) launched the Small Business Innovation Research Initiative (SBIRI) scheme in 2005. The main aim of the scheme is to strengthen existing private industrial units whose product development is based on in-house innovative R&D, encourage other smaller businesses to increase their R&D capabilities and capacity and cultivate the entrepreneurial spirit by creating opportunities for starting new technology-based or knowledge-based businesses by science entrepreneurs. The scheme started with a vision to promote early stage funding to private industries for high risk innovative and commercializable product proposals. The scheme, which has been advertised seven times, has received a total of 398 proposals from around 250 companies till date out of which nearly 75 percent are for early stage research (phase I) and around 20 percent are for scale-up and late development of research leads in phase II category while a few (5 percent) are a combination of the two. Out of this, 155 are collaborative proposals i.e with institutions/universities. The excitement and enthusiasm of the companies to the scheme can be gauged from the fact that within the first two months of advertising the scheme, the DBT received 71 full proposals and 17 concept proposals. So far, 37 projects have been sanctioned to a total of 32 companies, which are worth Rs 155 crore. The private sector has committed an investment of around 48 percent of the total while the rest would be from SBIRI funds of the government. A sum of Rs 45 crore has been released to companies till date out of which 16 projects are in the health sector, nine for industrial product and process development and eight in agriculture and allied areas. So far the biotech industry in the southern region has shown the maximum interest with Karnataka being the topmost state to submit proposals followed by Maharashtra, Andhra Pradesh, Tamil Nadu and Delhi. Actis Biologics Project: Sustained delivery of MSP36 Mumbai-headquartered Actis Biologics (ABPL), founded in December 2005, is an emerging biopharmaceutical company developing new therapies for life-threatening diseases. It has a strong focus in the areas of cancer and cardiovascular disease. The company is building a strong pipeline of clinical stage products (some of which are already in human trials) through in-licensing and internal research. ABPL has in-licensed technology platforms in these areas -- ribozymes, gene therapy, vaccines and recombinant protein technologies, all of which have shown promise in either human (phase I and phase II molecules) or in animal models (preclinical molecules). The company submitted a project titled "Delivery of MSP36 with Lenti Viral Vector" to the DBT in December 2005 that was approved for funding in 2006 with the loan sanctioned in April 2007 and funds dispersed in May 2007. The project is working on providing a cure for breast cancer through recombinant gene therapy. The gene in question is MSP36, whose inexpression represents a critical step in breast cancer progression and its replacement provides a key regulatory agent to inhibit breast cancer growth and metastasis at several levels; arrest the growth of the tumor cells, inhibit cell migration and metastasis, and down-regulate tumor neovascularization. The gene also targets a key growth factor than current therapies. Actis is taking the HIV virus and removing its inside guts to make it a safe virus which has no harmful effect. This is called a viral vector and in this case, the tamed form of HIV virus is referred to as the lenti virus vector. The code/sequence needed to produce MSP36 is added into the lenti viral vector before it is delivered into the body where it is integrated with the body cells. MSP36 is delivered into our cells and the body starts to produce the FGF protein and kill the cancer cells. The cancer treatment in this case is being brought in the form of a gene being delivered into the body, so that a corrected gene is used to produce the protein inside the body. This gene normally exists in the body and continuously produces the FGF protein, but for some reason has malfunctioned. The protein when present in the body stops the formation of blood vessels, which are needed to supply nutrition into the cells for them to grow and divide. By delivering the gene, the body reproduces the protein so that the blood vessel formation is stopped and MMP9 production is inhibited. MMP9 is a key protein that triggers metastasis. Yashraj Biotechnology Project: Development of highly specific immunoassays for prostrate and breast cancer through molecular characterization of existing markers and establishment of novel markers Established in 1999, Yashraj Biotechnology is focused on molecular diagnostics. The company's major activities are in the field of isolation, purification and bulk production of native antigenic proteins; customized formulations of native antigens in accordance with their intended use; contract manufacturing of existing products; contract manufacturing of antigens either through joint R&D venture or exclusive technology transfer for buyback; development of customized monoclonal as well as polyclonal antibodies; and cell-derived antigens. The company's project under the SBIRI scheme aims to characterize existing tumor markers applied in prostate and breast cancers and to search for new markers in order to enhance specificity of diagnostic assays. Speaking about the project, Dr Chander Puri, CEO, Yashraj Biotech, said, "This project is conceptualized on exploitable heterogeneity in molecules of prostate specific antigen (PSA) and breast cancer antigen (CA 15-3) and anticipates that extensive characterization of these molecules can lead to development of monoclonal antibodies having higher specificity and affinity. The characterized antigens and novel antibodies will be used to set novel assays for PSA and CA 15-3 cancer markers, which will help clinicians in differentiating prostate cancer from benign prostate hyperplasia as well as early stage specific diagnosis of breast cancer. The lack of specificity of PSA in PCa and BPH had lead to unwanted biopsies/misdiagnosis globally and has also has affected selection of therapeutics". Accordingly a time line has been set for each activity from sample collection, purification and characterization of markers, antibody development, assay set up, laboratory and clinical validation and up-scaling of processes. Yashraj Biotechnology has established the facilities targeted in the project for experimental work to progress, and the project monitoring committee of the DBT has appreciated the progress in achieving the objectives. The DBT has reviewed positively that the success of this project will have higher impact towards establishment of specificity for better clinical diagnosis of PCa, BPH and BCa, generation of patentable proprietary monoclonal antibodies, exploitation of novel cancer markers for the early diagnosis of BCa and indigenous manufacturing setup for continuous availability of various components for the benefit of Indian patients. This project, likely to be completed during the next three years, would thus have both technical and cost advantages, thereby making healthcare within the reach of resource constraint population. USV Project: Development of a vaccine capable of eliciting immunological memory for the prevention of typhoid USV is a leading healthcare company with a focus in branded generics, Active Pharmaceutical Ingredients (APIs) and biosimilars. In the area of biotechnology research, the company offers rDNA proteins and peptides backed by validated bioassays, clinical trials and intellectual property rights. In India, by Rx (prescription), the company ranks No. 1 in diabetes and cardiovascular disease segments. The company also has an active in-licensing program to enhance its product portfolio with a strategy to introduce innovative specialized products while retaining a focus on brand building. The company's project got sanctioned in 2007 and is designed keeping in mind that typhoid strikes children below five years of age and there aren't any approved existing vaccines for the same. Elaborating on the same, Dr KG Rajendran, head, knowledge cell, USV, said, "The present vaccine, which is a polysaccharide-protein conjugate vaccine, is expected to be effective in younger children below five years of age requiring less frequent dosing regimen. The incidence of typhoid fever is highest in this age group and there aren't any approved existing vaccines in this category. Typhoid fever remains a common and serious disease in many parts of the world, more prevalent in developing countries like India. There are a number of polysaccharide (Vi-Virulence factor) based vaccines currently available in the market for typhoid fever. However, the usefulness of these Vi vaccines is limited by its age-related immunogenicity and its T-cell independent properties; i.e., it does not elicit protective levels of antibodies in infants and young children, and reinjection at any age does not induce a booster effect". Navya Biologicals Project: Development of a platform for production of complex peptides and proteins Navya Biologicals was formed in June 2006 by two enterprising individuals, Dr KR Rajyashri, a molecular biologist, and Vinay Konaje, a chemical engineer. The company is into cloning of genes and expression of proteins (by which the information in a gene is translated into a protein). Navya Biologicals is working on the development of a novel technology platform for expression of complex proteins (of therapeutic and industrial value) that today cannot be expressed in sufficient quantities due to inherent issues associated with existing expression systems. The project got sanctioned in June/July 2007 and was initiated in August 2007. Speaking on the progress of the project, Vinay Konaje, one of the founders, said, "This is a 'phase I' program of 18 months, which is progressing on schedule presently. We hope to begin validation of the platform in the next 3-4 months. The technology platform would enable complex proteins to be mass-produced. It is either technically unviable to produce these proteins today (despite their therapeutic potential) or is commercially unviable with the available technologies. A couple of high value but complex therapeutic molecules have been chosen to validate the platform". Navya is expecting to address a potential global market of approximately $10 billion on successful completion of this program and has already identified proteins of commercial/therapeutic value that can be produced economically using this platform. It hopes to complete the project by March 2009. SBIRI, a boon There is more to come in the next few years if we go by the response and the momentum that the scheme has gained in the first few years. It would only enable the translation of technological concepts from the laboratories into commercially viable products by providing companies the skills and financial capital. Dr KG Rajendran, head, knowledge cell, USV, commented, "SBIRI as a scheme has not only offered financial assistance to support the R&D, but also extended timely expertise as and when required. Besides it also helped us to get access to scientific resources leading to advancement of the project work". Dr Sanjeev Saxena, CEO, Actis Biologics, said that though the entire process, from getting an approval for the proposal to getting the funds, is lengthy, it has its advantages. "Although it took us time from the time the funds were approved to the time they were disbursed, the process as a whole is very effective. It showed that the government had appointed people who were judicious in their approach and very committed and willing to do a thorough due diligence on all companies including ours to make sure only deserving candidate companies got the funds". Dr Chander Puri, CEO, Yashraj Biotech, further validates the merits of the SBIRI scheme, "Our partnership with the DBT for this project under SBIRI program has helped in critical review and approval of the project concept by SBIRI core committee; availability of research grant and soft loan eliminating financial limitations; bringing accountability due to public money involvement and project monitoring system; and a feeling of the feather in the cap with in such a short time of existence". It is also felt that with the reluctance on the part of venture capitalists to fund such projects, SBIRI is a boon for upcoming companies to realize their potential to be at the forefront of cutting edge research. Vinay Konaje, one of the founders of Navya Biologicals, is of the same opinion. "R&D projects of the kind that Navya Biologicals is today executing would be perceived as high risk by conventional lenders/banks/VCs who do not understand the dynamics of the biotech sector and are loathe to investing in high risk-high return projects these days". He added, "The Indian biotech industry cannot progress beyond a particular point by simply reverse engineering existing molecules. Hence initiatives such as SBIRI as absolutely required for upcoming companies like Navya Biologicals who are keen on putting India at the forefront in areas like biotechnology and want to make a difference to the healthcare sector, but do not have enough financial resources of their own to do so". Dr Sanjeev Saxena added, "Generally venture capital (VC) companies throughout the world are reluctant to fund gene therapy companies as they perceive a high risk due to past failures of gene therapy companies, but SBIRI allows us to fund such projects". He is optimistic though that once the project starts showing promise, the PEs and VCs will take a step forward and will be willing to bet and take a chance and risk their investment. Shalini Gupta with inputs from Nayantara Som & Jahanara Parveen     ]]> <![CDATA['Biomanufacturing solutions will drive the business']]> https://biospectrumindia.com/news/95/2533/biomanufacturing-solutions-will-drive-the-business.html https://biospectrumindia.com/news/95/2533/biomanufacturing-solutions-will-drive-the-business.html Wed, 07 May 2008 13:07:00 +0530 New Page 1 'Biomanufacturing solutions will drive the business' -Dr Martin D Madaus, chairman, president & CEO, Millipore Corporation Millipore Corporation is a life science leader providing cutting-edge technologies, tools, and services for bioscience research and biopharmaceutical manufacturing. As a strategic partner, it collaborates with customers to confront the challenging human health issues. From research to development to production, its scientific expertise and innovative solutions help customers tackle their most complex problems and achieve their goals. Millipore announced the opening of a new state-of-the-art applications and training facility in Singapore to meet the growing needs of its biotech customers who have operations in Asia. In an interview with BioSpectrum Dr Martin D Madaus, chairman, president and CEO of Millipore Corporation shared his thoughts about the opportunities for the company in Asia Pacific region and the shift in the company's strategy. Excerpts: Considering the market potential in Asia Pacific, how much growth Millipore can foresee coming from the region, in the next five years? Currently, Asia Pacific contributes about 17 percent to the total sales of Millipore. And from our perspective, I see the portion of the Asian business will get bigger with every passing year. This 17 percent will be 20 percent in the near future. So many research activities are taking place spanning from clinical research, drug development to production in the region. The fact is: this is not just because some international companies are moving into the region. This is, because of the home-grown companies. For example in India and China, the pharmaceutical companies are very strong. That is a good sign. In think in about 10 years, these markets will become very large. We will be close to 20 percent in five years and probably a quarter of our sales at least in next 10 years will come from the region. Of course, we don't want other regions to go down to make it faster. So, it all depends on relative scenario. You know, the US biotech business is still very strong. When you look at biotech, 57 percent of our biotech business is from US. But within 10 years, we will see a meaningful difference. What could be the driving factors for the growth of the region? The driving factors for the region include demographics, increasing prosperity and GDP growth. There is a need for a very large portion of middle class prosperous Asians to have world-class treatment. Which countries in Asia Pacific region are emerging as major players for the range of products and services Millipore is offering? We are currently focusing on Japan, India, China, Singapore and Korea. In near future there will be more countries on the list. How about the market opportunities in India and China? India already has an established pharmaceutical industry with over 80 FDA approved plants now. This established industry focuses mainly on small molecules. The biotech business too is growing there. And most of this is homegrown. That is why we focus on India and we are very successful there. We have similar opportunity in China, where more emphasis is on research side and general laboratory market. The pharmaceutical industry in China is more focused on research and development and less on production side. Do you feel that the current recession in US will have any impact on life sciences industry in general and Millipore in particular? The life sciences industry has historically been very little affected by recessions. I wouldn't say life sciences industry is recession proof, but there will be some general impact. There will be other factors that will impact the life sciences industry. However, in spite of great uncertainty in stock market I feel good about the future. There are some clouds on horizon for the classical pharmaceutical, but biotech looks strong. We are benefiting here from the shift; for example, India and China are doing more of the work that used to be done in the US or Europe. I think there will be some impact, but it will be limited. And it will not affect the growth of the company in a meaningful way. Millipore was known as filtration and separation company. From the last year, focus of the company has changed to include entire life sciences. What brought about this change of focus? The industry, our business and our competitors are going through a phase of consolidation. Also, strategically, we need to make sure that we grow faster than the market, so that we are not marginalized. And we can do so with acquisitions only. It meets our need to grow dramatically faster. Besides, it also helps if you want to get into the new fields such as antibodies. What are the different divisions that are driving the growth of the company? The first driver will be the drug discovery division. It is doing very well. It is relatively small in our portfolio but has a huge growth potential. The other one is lab water. It continues to go stronger. Stem cells will be another driver for us. The separation technology and bio production will be combined with the disposal manufacturing, the combination that we call biomanufacturing solutions will help us drive a lot of business. Right now, we see a lot of growth there. Narayan Kulkarni   ]]> <![CDATA[The echo of partnering]]> https://biospectrumindia.com/news/95/2528/the-echo-of-partnering.html https://biospectrumindia.com/news/95/2528/the-echo-of-partnering.html Wed, 07 May 2008 13:06:00 +0530 New Page 1 Bangalore Bio 2008 The echo of partnering The three-day Bangalore Bio 2008 event successfully concluded on April 26, 2008. It saw the participation of over 85 international and national speakers, over 700 delegates from the industry, R&D, policy makers and academia, and 150 leading global and Indian exhibitors. This was the eighth edition of Bangalore Bio 2008 and the event attracted the largest gathering of international biotech fraternity. There were more than 100 delegates from 14 countries like the US, Australia, France, UK, Germany, Italy, Holland, Japan, and Malaysia participating in this event. Merck & Co. Inc, one of the world's biggest biopharma companies, was the global partner. Victoria State, Australia was the country partner with 16 companies and delegation of 40 professionals. They had conducted over 100 B2B meetings with the Indian companies during the three days. They also had a meeting with the Department of IT&BT, Government of Karnataka. France participated as the international partner with 15 companies from health sciences and biotech sector and delegation of 45 biotech experts. The French companies had over 150 B2B meetings with the Indian companies. In tune with the core theme of global partnering, the international conference featured four successful case studies of cross border partnering with Indian enterprises addressed by Advinus, Nicholas Piramal, Connexios Life Sciences, Rheoscience and Avesthagen. Highlights of the event Nobel Laureate Prof. Sidney Altman delivered the inaugural keynote address at the Bangalore Bio 2008 and called for investing more on basic research. Over 35 papers were presented by young scientists and innovators in the poster session. Bangalore Bio 2008 facilitated over 500 one-to-one business meetings for potential collaborations, partnerships and alliances. Many young researchers and scientists from leading Indian and international research laboratories like CSIR, ICAR, DAE, DBT, and DST participated in Bangalore Bio 2008. Department of Biotechnology shared its vision and plans for setting up the National Biotech Regulatory Authority. CSIR director general, Dr Samir Brahmachari, in his vision talk, impressed the gathering by sharing the success story of the country's largest gene decoding study. Novozymes, Syngene, Serum Institute and Rasi Seeds bagged the first BIO Excellence Awards at the Bangalore Bio 2008.   ]]> <![CDATA[Glimpses into the new biotech regulatory set-up]]> https://biospectrumindia.com/news/95/6027/glimpses-into-the-new-biotech-regulatory-set-up.html https://biospectrumindia.com/news/95/6027/glimpses-into-the-new-biotech-regulatory-set-up.html Wed, 07 May 2008 12:50:00 +0530 New Page 1 Glimpses into the new biotech regulatory set-up After having sewn up the National Biotechnology Policy in November, 2007, the Department of Biotechnology (DBT) has shifted gears to give a concrete shape to the highly-contentious issue of setting up a National Biotechnology Regulatory Authority (NBRA) which will handle all biotech related regulatory affairs. DBT has prepared a draft National Biotechnology Regulatory Act, which will be placed before the Parliament after September 2008. Sharing the contours of the new biotechnology regulatory authority with industry leaders during the Bangalore Bio 2008 meeting in Bangalore on April 26, Dr S R Rao, advisor, DBT, announced that the inputs and suggestions from the industry and other biotech stakeholders will be gathered in the next three to four months. "NBRA will take into account all the concerns of the industry and try to eliminate overlapping of the areas of other similar authorities in order to act as a true catalyst for the industry. It will not hesitate to take expertise and suggestions from any person or institution of any country," Rao said. He said the Act could cover the manufacture, production, commercial release and import of all genetically modified organisms (GMOs). The Act will confer relevant powers on NBRA to function as a safety net that ensures all biotech products are subjected regulations related to safety. To avoid conflicts with existing legislation that overlap with some aspect of GMOs, specific categories of GM products which are currently regulated by other ministries/regulators will be kept out of the purview of NBRA. Essentially this means that GM foods and recombinant drugs will not be covered by NBRA but by existing regulatory guidelines of ministries of food and health. There will be however be some coordination mechanism within NBRA to deal with other regulators. DBT team has already held extensive consultations with regulators handling biotech segment in the US and Canada in recent months. Rao said consultations with 10-12 biotech regulators from other countries are also going to be done to learn from their best practices. Similar consultations will be done with regulators of other economic activities in India too to learn from their experiences and avoid the mistakes made by them.For the purpose of this Act, "modern biotechnology" means the application of in vitro nucleic acid techniques, including recombinant deoxyribonucleic acid (DNA) and direct injection of nucleic acid into cells or organelles, or fusion of cells beyond the taxonomic family, that overcome natural physiological reproductive or recombination barriers and that are not techniques used in traditional breeding and selection. It specifically excludes: in vitro fertilization; natural processes such as conjugation, transduction, transformation; polyploidy induction; and accelerated mutagenesis. The draft plans of the legislation will be available on the DBT website and suggestions on it could be emailed to nbra.dbt@nic.in from May 1, 2008. Regulatory Branches The NBRA will be headed by an eminent biotechnologist and the Authority will be supported by two advisory bodies--Inter-Ministerial Advisory Board (IMAB) and a National Biotechnology Advisory Council (NBAC). The Act envisages the IMAB to promote and ensure inter-ministerial and departmental coordination as regards to the implementation of the regulatory system. The Board will have high level representatives from key line ministries and selected state governments. Similarly, the NBAC will address overarching policy-related issues that may affect the regulation of the country's biotech activities. The council members will include representatives from the scientific community, private sector and the civil society. Both these advisory bodies, however, will not be involved in product-specific reviews or decision making. The draft legislation has suggested that the NBRA function through three major branches to deals separately with agriculture and fisheries, human and animal health, and industrial and environment applications. So the agriculture, forest and fisheries branch (AFFB) of NBRA will regulate GM plants, animals and micro-organisms used in agriculture, forestry or fisheries, including aquaculture. The human and animal health branch (HAHB) will regulate all GMs with applications in human and veterinary health, such as assessing the potential environmental risks and benefits associated with the application of GMOs in pharmaceutical development or recombinant livestock vaccine production. The industrial and environmental applications branch (IEAB) will regulate GMOs used in industrial manufacturing and in environmental applications, such as the use of GMOs for bioremediation of contaminated sites or oil spills. Further, each branch will be headed by an eminent scientist who is an expert in that segment and will be designated as the Chief Regulatory Officer (CRO). NBRA will provide each branch with a Regulatory Policy Unit (RPU) and a Risk Assessment Unit (RAU). The RPUs will develop and implement branch specific policies, write the rules and provide guidance to the users. The RAU will handle the tasks of taking up science-based regulatory assessments on a regular basis. In addition, each branch will be provided with Scientific Advisory Panels (SAPs) to gather expert inputs. Another innovative decision is the plan to set up six cross-sectoral offices that provide inputs to the entire NRBA set up. These include: National and international policy coordination unit Communications and outreach unit Legal unit Economic analysis unit Monitoring, compliance and accreditation unit State level offices Legislative Impact For NRBA to function effectively, some amendments will be required in the existing regulatory Acts and Rules. These include: Rules for the manufacture, use, import, export and storage of hazardous microorganisms or genetically engineered organisms or cells, 1989, issued under the Environment Protection Act, 1986. Drugs and Cosmetic Rules (8th amendment), 1988. Plant Quarantine (Regulation for import into India Order 2003) The New Seed Bill, 2004 The Food Safety and Standards Act, 2006 Biotech products relate to many areas and there are bound to be many conflicts between regulatory authorities. To nip such problems in the initial stage itself, the NBRA legislation would provide for regulatory exemptions for processes related to the production of GMOs and or products derived from GMOs that are regulated under other acts that address environmental protection and human health safety in a manner equivalent to the NBRA Act. For example, NBRA could recognize that the Food Safety and Standards Authority (FSSA) and DCGI (Drug Controller General of India ) are the competent authorities for development and commercialization of GM foods and recombinant drugs. Similarly, GM foods and pharmaceuticals, which have traditionally been regulated by health ministries worldwide, providing public confidence in decision making. For example, FSSA could refer the regulatory packages it receives for GM food approvals to the NBRA's Research Advisory Unit. This unit could function as the scientific panel on GM foods as defined in the FSSA. Also, the NBRA could take up the safety assessment on behalf of FSSA. Industry Views After Dr Rao announced the contents of the proposed regulatory set up, there was a lively discussion on the topic during the Bangalore Bio event. The president of the Banglaore-based Association of Biotechnology-Led Enterprises (ABLE), Dr KK Narayanan said: "As there are several branches under biotechnology, constituting just three branches under NBRA will not be enough and there is a need for many other branches to be included such as agriculture, fisheries etc separately instead of clubbing them all." Other panelists and the delegates expressed concern over the opposition to GM crops by the state governments of Kerala and West Bengal. They suggested that what is good for India should be decided by the pure scientific merits only, but not by the partisan attitudes, panelists opined. Panelists suggested a need for setting up a think tank to give suggestions to NBRA on a continuous basis. Narayanan Suresh in Bangalore   ]]> <![CDATA[Another acquisition for Dr Reddy's]]> https://biospectrumindia.com/news/95/5903/another-acquisition-for-dr-reddys.html https://biospectrumindia.com/news/95/5903/another-acquisition-for-dr-reddys.html Wed, 07 May 2008 12:35:00 +0530 New Page 1 DRL captures numero uno position in generic market Another acquisition for Dr Reddy's Dr Reddy's Laboratories has signed a definitive agreement to acquire Dowpharma Small Molecules business associated with Dow's Mirfield and Cambridge, UK sites. Dr Reddy's Laboratories (DRL) is in news once again. Towards the beginning of April, the $1.2-billion Indian pharma major, and one of the world's leading generics players, announced that it had entered into a definitive agreement with the US- based Dow Chemical Company to acquire a portion of Dowpharma Small Molecules business associated with its UK sites of Mirfield and Cambridge. The financial terms and conditions of this deal is undisclosed for the time being. The transaction is scheduled to close on April 30, 2008 pending regulatory approval. "We will start consolidating the acquisition from Q1 FY09," confirmed a DRL source. The month of April has seen two significant acquisitions for DRL. Just three days following the Dowpharma agreement, DRL also announced the acquisition of Jet Generici Srl, a company engaged in the sale of generic finished dosages in Italy, completed via Dr Reddy's Italian subsidiary, Reddy Pharma Italia SpA. Company insights The Cambridge site of Dowpharma was primarily used for R&D while the Mirfield site was used for manufacturing purposes. The two sites of the business employs around 80 personnel. Dowpharma offers contract manufacturing services, serves the pharmaceutical and biopharmaceutical industries with services in technology, products and services for clients in drug discovery, development and manufacturing. Parent company, Dow Chemical's annual sales clocked $54 billion with an employee strength of 46,000 worldwide and has a broad range of services. Dowpharma has also has an active manufacturing site in Midland, Michigan and a biopharmaceutical site in San Diego. In fact, DRL is not the first Indian company. Dowpharma has had a transaction, confirmed Michael Altmann, global communications manager, Dowpharma, "In 2007, the Serum Institute of India, licensed the Dowpharma Pfēnex Expression Technology, for the development and production of low-cost vaccines." Pfēnex Expression Technology is a Pseudomonas-based system, enables customers to express their recombinant protein or peptide reliably and cost-effectively. This technology can increase protein expression, secrete proteins to the periplasmic space, maintain solubility, increase downstream yield, scale up easily, address protease issues, and improve activity characteristics, lower cost of goods. In developing Pfēnex Expression Technology, Dowpharma continues to invest a significant amount of research and development in identifying high-performing strains of Pseudomonas fluorescens and further improving them through the application of sophisticated genomics tools. At the 2007 CPhI Annual Conference in Milan, Italy, Dowpharma won the bronze innovation award for the use of Pfenex Expression Technology for the development of biocatalysts. For DRL, despite the reported financials reflecting a 20 percent decline in revenues and the Mexico business recording a decline of 31 percent , there was an upward growth in other areas as per the Q3 FY08 results announced this January. DRL had declared that "in the Custom Pharmaceuticals Service (CPS) business, the organic business is in a high growth mode and continued its growth momentum in this quarter as well." In the same quarterly results, DRL registered an overall growth margin of 49 percent in Q3 FY08 as against 44 percent in Q3FY07, gross margin in APIs was at 32 percent compared to 39 percent in the third quarter of last year. Gross margin in the generics segment, which includes the US as well as Europe, was at 45 percent in this quarter as against 36 percent in Q3FY07. Benefits from the deal The Dowpharma acquisition is sure to give a boost to DRL's R&D and manufacturing capabilities, especially for its CPS business which is a high growth area for the company The acquisition is also a sure sign of DRL's attempt to penetrate other key markets in Europe. "We will execute towards building a sustainable and profitable presence in the key markets of Europe over the next few years," confirmed GV Prasad, CEO, DRL. From its commercial partnerships in the past, DRL had established a strong presence in North America, Europe and the BRIC nations out of which Germany was and still is an important market for the company. Dr Reddy's will also have a non-exclusive license to Dow's Pfēnex Expression Technology for biocatalysis development. Satish Reddy, managing director and chief operating officer, Dr Reddy's Laboratories, said, "The proprietary chiral and biocatalysis technology at the Cambridge site and the scale up capability in the Mirfield site will add significant value to the company. This acquisition will also bring strengths in industrial synthesis of complex prostaglandins and carbohydrate chemistry. These newer capabilities will add to our existing R&D and commercial infrastructure to position Dr Reddy's as a leading provider of custom pharmaceutical services globally." DRL sources also confirmed that "The acquisition would give us access to technology that we may not have within. It also allows us to offer technology-advantaged services to our customers, ultimately leading to very high quality services to our customers." Also, for the Hyderabad-based company, the acquistion will also include the relevant business, customer contracts, associated products, process technology, intellectual property, trademarks as well as the transfer of the facilities at Mirfield and Cambridge in the UK. On the other hand, for Dowpharma the agreement is a strategy to reconfigure its portfolio to ensure sustained growth. "We are preferentially investing in the high-return performance product businesses that allow us to better compete in downstream markets. The divestiture of Dowpharma frees the resources that we will use to further strengthen our performance plastics and chemicals offerings," added Altmann. However, the agreement only covers the Dowpharma assets in the UK at Cambridge and Mirfield and Dow's US sites will remain untouched. Altmann clarified, "Dr Reddy's will have complete control of the Cambridge and Mirfield assets upon closing of the agreement. These assets will become part of Dr Reddy's and will no longer be connected to Dowpharma. The Dowpharma sites and businesses in the US as well as the Pfēnex Expression Technology remain with Dow and are not part of the transaction." What next? Post the DRL-Dowpharma agreement, commenting on future plans, Altman asserted, "It is public knowledge that Dow has been seeking outside funding to support and expand the biopharmaceutical portion of the business. I cannot comment on other plans." DRL is now all geared up to dominate the biosimilars market and launch its first biosimilar product in Europe by 2010. Nayantara Som   ]]> <![CDATA[Rethinking R&D]]> https://biospectrumindia.com/news/95/2889/rethinking-rd.html https://biospectrumindia.com/news/95/2889/rethinking-rd.html Wed, 07 May 2008 12:26:00 +0530 New Page 1 Rethinking R&D R&D in Indian biotech is poised for a big leap. With more and more companies shifting focus from generics to new drug discovery research, innovation seems to be the buzz word driving the industry, with key players hiving off their R&D units to further research. Sun Pharma, Nicholas Piramal and Ranbaxy belong to a new league of companies, who have spun off their R&D units into separate entities, thus setting the trend for others to follow suit. However, Hyderabad-based Dr Reddy's Laboratories recognized the need for new drug discovery and development over the next decade as early as 2005. It established Perlecan Pharma, India's first integrated drug development company along with Citigroup Venture and ICICI Venture. Glenmark demerges generics business into a separate entity With companies hiving off their R&D arms, Glenmark Pharmaceuticals Ltd (Glenmark), recently implemented the reorganisation of its business into speciality and generics, thus transferring its generics and Active Pharmaceutical Ingredients (API) businesses to its subsidiary, Glenmark Generics Limited (GGL). The reorganization process had begun in Q3 FY 2007-08. GGL will handle the development, manufacture and distribution of generic formulation and API businesses. The parent company Glenmark Pharmaceuticals Ltd will continue to directly manage the novel R&D, biologics and branded formulation businesses of the Glenmark group including India, Brazil, Rest of Latin America (excluding Argentina), Russia/CIS, Africa and Asia. Why hive off? Dr Reddy's - Advancement of NCE assets For Dr Reddy's, one of the earliest companies to recognize the importance of research, the formation of Perlecan Pharma was an innovative financial agreement, primarily a derisking strategy given the unpredictability of novel research and the large financial commitments involved therein. "Being the first Indian pharma company to bet big on NCE research, Dr Reddy's has always believed in the success of NCE research to establish a sustainable, growth oriented business. Perlecan Pharma provided Dr Reddy's drug discovery program, a model to rapidly advance its existing as well as future NCE assets through phase II trials and seek out-licensing, co-development or joint commercialization opportunities thereby enhancing the value of the pipeline," a spokesperson from Dr Reddy's was quoted as saying. Sun Pharma - Promote growth of both generics and drug discovery by separation Mumbai-based Sun Pharmaceutical Industries soon followed suit by demerging its R&D operations, including new drug delivery systems, into a new company called Sun Pharma Advanced Research Company (SPARC). The demerger was approved by the board in February 2006 while the transfer of business happened from March 1, 2007. The difference between genetic reverse engineering and innovative R&D in terms of risk profile, longer timeframes and considerably large resource requirements in the future was the principal reason for the demerger. "The rationale for the demerger was to completely separate out the innovative and generic businesses, because they have inherently different characteristics. Drug discovery, both new molecules and drug delivery systems, is a high risk-high return proposition, and the challenges-resources, uncertain time to market and likelihood of a product ever coming to market are very different from those for a generic business," Dilip Shanghvi, CMD, Sun Pharma, said. "The generic business has a defined timeframe, uses known and well demonstrated skill sets and has certainty of reaching market. The idea was to offer both the businesses the kind of environment that would be most conducive to growth," he added. Nicholas Piramal - Strengthen research on NCEs In August 2007, the board of directors of Nicholas Piramal India Limited (NPIL) approved the proposal to demerge its New Chemical Entity (NCE) research unit into a separate company. This was done in order to strengthen research on the NCE front on which it started work since 2002. The company which expected to have eight compounds in clinical trials by end of its 07-08 financial year, also wanted to minimize the increased spend as clinical development costs constitute about 2/3rd of the total R&D cost of a drug. Hence, it wanted to complete development up to proof-of-concept (end of phase II) for all its pipeline compounds and bring to market certain niche compounds on its own. The company expects to list the demerged entity by May-June 2008. Wockhardt - Focus on R&D business In January this year, pharma major Wockhardt spun off its innovative R&D business into a separate company. The new company is expected to be involved in new drug discovery program and the innovative new technologies being developed by the R&D team. The company will be a listed company and is scheduled to come into effect from January 1, 2009. Commenting on the development, Wockhardt chairman, Habil Khorakiwala, said, "The R&D business has great potential and needs to be a focused entity for carrying out unrelenting research activities for the future. At Wockhardt, we recognise this fundamental need and are re-structuring our R&D business to unlock true value for all our stakeholders. This will ease the company to invite strategic investors interested in the R&D business." Ranbaxy - To create an independent pathway for NDDR Ranbaxy cleared a scheme of demerger of the company's New Drug Discovery Research (NDDR) unit into a subsidiary, Ranbaxy Life Science Research Ltd (RLSRL) in February 2008. The move was cited to help create an independent pathway for NDDR with dedicated resources and an enhanced focus for long-term growth. The new R&D unit is expected to help leverage the company's state-of-the-art research infrastructure and a highly skilled scientific talent pool by aligning assets with priorities to accelerate the company's drug discovery programs. "The demerger of our NDDR unit into a separate entity establishes a robust structure to carry out path breaking research at the cutting edge of modern medicine. It will also enable RLSRL to create intellectual property at a faster pace while positioning it for the future," Malvinder Mohan Singh, CEO and MD, Ranbaxy Laboratories said. The proposed R&D arm is expected to be listed in the middle of this year. Analysts speak An increased focus on NCEs seems to be one of the principal reasons for companies to hive off their R&D units, but the underlying reason runs deep. According to Hitesh Gajaria, executive director, KPMG India, "Generics have always been the mainstay of Indian pharma companies and their entry in the NCE/NDDS discovery and development segment is relatively new. In the last few years, a number of leading Indian companies have entered this space and successfully scaled up their R&D operations. However, they have traditionally relied on their generics business to fund their discovery operations." He explains that as a company moves up the discovery value chain, funding becomes a serious issue. And in the light of the global generics market under severe pricing pressure, relying on this funding channel solely can restrict the ability of Indian pharma companies to further their R&D efforts. "This is where hiving off their R&D units into separate entities helps companies explore innovative long-term funding channels including attracting strategic investors to advance their discovery initiatives. Such a strategy improves focus on the NCE business and also enhances the scope for collaborations (out-licensing, in-licensing and joint development and commercialization) with other experienced players and facilitates easier expansion of discovery initiatives with increased flexibility. Further, this helps maintain focus on the traditional generics business segment," he added. Utkarsh Palnitkar, partner, transaction advisory services and national sector leader, health sciences, Ernst & Young India, added in the same breath, "Creation of a separate company is an innovative way to mitigate the risks involved in the drug discovery business where, despite years of expensive research, the success ratio is still small." "In most cases, the concerned companies have restricted the hive off to new chemical entities (NCEs) only. However, the drug delivery system, clinical and the generic part will remain intact with the parent. The rationale is that the generic business and innovation are two totally different businesses, with different time frames, certainty profiles and investments. The demerger thus provides greater flexibility and impetus to the drug discovery research program while unlocking significant value for the company and its shareholders," he adds. NCEs in the pipeline According to Gajaria, Indian players will spend $500 million in 2010 on NCE research and $1.2 billion by 2015. In the coming years, Indian companies will have gained significant expertise in this space and will certainly have some of its molecules launched globally. Dr Reddy's currently has four molecules in its NCE pipeline out of which only one is being co-developed along with Perlecan Pharma. The drug candidate DRL16536, currently in phase I trials and aimed at treating diabetes was one of the four new chemical entities that the company started with in 2005 with the formation of Perlecan Pharma. DRF-2593 co-developed along with Rheoscience, UK, is currently in phase III trials, DRF-1042, an anticancer target being co-developed along with Clintec International, UK, is in phase I clinical trials and DRF-2546 that addresses COPD is in pre-clinical stages. Sun Pharma, which had demerged both its drug discovery and drug delivery units, has four NCEs in the pipeline with one of them soon to undergo phase III trials. Nicholas Piramal is developing 13 new chemical entities (NCEs) and expects to launch its first patented drug by 2010. Its lead molecule P-276 has recently been approved by the USFDA and clinical trials will soon commence for multiple myeloma â€“ a devastating type of cancer, in collaboration with Harvard Medical School and Dana Faber Cancer Centre, USA The company has two drug candidates in inflammation, one undergoing pre-clinical development and the second an oral herbal product, whose safety and efficacy is being evaluated in two phase II clinical trials in India. In the field of infectious diseases, an anti-fungal herbal product is currently in phase II clinical trials in India. A highly potent antibiotic drug candidate- active against methicillin resistant Staphylococcus aureus (MRSA) and vancomycin resistant Enterococcus (VRE) is in late pre-clinical development. Wockhardt has two new chemical entities (NCEs) under clinical development. WCK 771, in phase II of clinical trials and is targeted at diverse staphylococcal infections like MRSA (Methicillin-Resistant Staphylococcus Aureus) - infections caused by a type of bacteria that is resistant to certain antibiotics - and VISA (Vancomycin Intermediate Staphylococcus Aureus). WCK 1152, is targeted at respiratory tract infections, including hospital-acquired infections, and is undergoing phase I clinical trials, to assess its safety. Ranbaxy has around 10 programs comprising one molecule undergoing phase IIb trials (anti-malarial RBx 11160), another has completed phase I (RBx 9841 for urology), four are in pre-clinical development and rest in early stages of development. The company feels that if all goes well, its anti-malaria molecule may become the first NCE to come out of an Indian lab. RBx-14255, the anti-bacterial molecule belonging to the Ketolide class, has completed exploratory toxicity studies. The IND enabling studies will be initiated in Q2 2008. As per the agreement with GSK in the COPD segment, the identified compound for this therapeutic category has been scaled up and IND directed toxicology and safety pharamacology studies have been initiated. In the anti-bacterial therapeutic segment several compounds that show much improved developability have been identified and are currently being profiled in order to identify a pre-clinical candidate. The future of R&D Though R&D requires huge investments, it does not guarantee new drugs. According to Hitesh Gajaria, sector head, pharma, KPMG India, "At present a few Indian pharma companies spend as much as 7-9 percent of their revenues on NCE and NDDS research, while the global average is over 14 percent. If an Indian player can successfully manage the R&D spin-off, this trend can significantly boost their investments in discovery research. So is spinning off R&D a bubble waiting to burst? Would R&D units continue to attract investors? According to Hitesh Gajaria, executive director, pharma, KPMG India, "The ability of the Indian pharma companies to attract private equity investors would depend on parameters such as the breadth and depth of their NCE pipelines and the development status (phase, I /II/III etc.), target therapeutic indications and their market potential, the company's track record in developing molecules for similar therapeutic category, risk profile and potential in-license/out-license opportunities." Rajesh Jain, JMD, Panacea Biotec, is equally buoyant about this trend. "In view of the steady performance of Indian companies in domestic and international markets in the last decade, R&D would become a favorite domain for investments by private equity players as well as VCs, he said. Gajaria though adds a cautionary note. "However, given the high-risk nature of this business, in our view, private equity investors that have a longer-term investment horizon of 8-12 years may be better funding channels as compared to the capital markets." Shalini Gupta with inputs from Nayantara Som and Jahanara Parveen "We typically invest 8-10% of turnover on R&D" New Page 2 "We typically invest 8-10% of turnover on R&D" -Dilip Shanghvi, CMD, Sun Pharmaceuticals What percentage of the company's revenues is spent on R&D? At Sun Pharma Advanced Research Company (SPARC), the revenues will begin only once it licenses out a product or a technology, or has a product in the market. It has a burn rate of about $20-25 million annually, and no revenues. It will need $65-70 million to take projects ahead in the next few years. At Sun Pharma, which is a generic pharma company, we typically invest 8-10 percent of our turnover on R&D. How much money do you plan to invest in the R&D unit(s) in the next few years and how much has been invested till date? SPARC is likely invest $65-70 million in the next few years. Has the unit(s) generated any revenues so far? How many people does it employ? This year it had a small income related to technology transfer. SPARC employs 180 scientists across two research centers in Baroda and Mumbai. What is the business model of the company after the hive off? The revenue model is that of any R&D company, it creates intellectual property and seeks to maximize the returns on this asst. It will bring products and technologies to market across different markets, either on its own or with partners. What is the vision for the R&D unit in the next few years? Are you looking at any acquisitions? Broadly speaking, while maximizing the opportunity for each product, SPARC will also attempt to experience and internalize the basics of the new drug development lifecycle by carrying a drug candidate on its own, as long as possible. For SPARC, acquisitions are not a priority. How much equity does the parent company hold in the R&D unit and how much will be held by the shareholders (percentage wise)? In the way we have demerged our R&D, there is no parent company. No equity is held by Sun Pharma in SPARC. I own about 65 percent in Sun Pharma and as well as in SPARC, and the rest is with the public. All shareholders of Sun Pharma received the same number of shares in the R&D company (SPARC) as they had in Sun Pharma. Sun Pharma Advanced Research Company (SPARC) is listed on the stock exchange. What are the benefits to the investor of getting listed? The benefit to the investor is that depending on their own risk profile and the investing horizon, an investor can invest either in a generic company with predictable returns (Sun Pharma), or a research company with uncertain timeframe but a different magnitude of upside should a product clear all the phases of research and reach market (SPARC). Nayantara Som   ]]> <![CDATA[Claris now targets biogenerics]]> https://biospectrumindia.com/news/95/2939/claris-now-targets-biogenerics.html https://biospectrumindia.com/news/95/2939/claris-now-targets-biogenerics.html Wed, 07 May 2008 12:08:00 +0530 New Page 1 Claris now targets biogenerics Having consolidated its plans in the hospital critical care market, Claris Lifesciences now intends to emulate the same in the biotechnology space. A long with its globalization ventures and consolidation plans in the Indian critical care segment, Ahmedabad- based Claris Lifesciences, having a CAGR of 40 percent for the last five years, has now forayed into the biotechnology arena. Claris Biosciences, which was initiated in 2007, is an extension of the company's overall strategy to target niche markets and biotech was an obvious answer to this business model. Commenting on this venture, Aditya Handa, CFO, Claris Lifesciences, explained, "Basically we did not want to get into the traditional areas as they are highly over-competitive in nature. Our strategy is to focus on our existing strengths in niche areas and at the same time give in our best to focus on those. This will eventually lead to a strong base building in knowledge, which is done by investing in manpower, training them, setting up robust capabilities and then approaching the need for innovation. This is the first phase of our business strategy and will prove to be a major differentiator for us in the market in addition to our strong distribution network." While focusing on key therapy segments namely oncology and nephrology, the company went on retrospection on its major strengths and the opportunities that these key strengths had to offer. "We chalked out on various options and there was the obvious temptation to get into areas like lifestyle diseases, but we have tried our very best to stay from them. We came to the conclusion that Claris has a strong hold in the hospital critical care segment and institutional customers, developing and manufacturing injectables. Biotechnology then came as an obvious answer," Handa added. "Claris is a major player in the injectable domain and half of the injectables in the market are all biotech products. A number of these high-value biotech products are going off patent and this itself provides a huge opportunity for any company who has the capability to tap this space. Moreover in biotech, the obvious capabilities that are required are both from the technical and marketing side and both these areas have a direct link with the trend followed at Claris Lifesciences. This results straight in synergy in competency in the manufacturing front which has been our forte," stated Handa. Products With the venture kicking off, biogenerics is one of the main targets for Claris. The company's mammoth expansion ventures across the globe in the past has been an impetus for channelizing its plans towards biogenerics. "The first step would be going into biogenerics because that will be the next big thing," Handa disclosed. Collaborating with research institutes both in India and abroad will be one such strategy. Claris already has a strong global presence in the European, Central and South American, Asian, Korean and Pacific markets. This, Handa believes will take them way forward in the biogenerics market. Here, apart from entering the regulated markets of the US and Europe, Claris is also eyeing emerging markets, which it believes will eventually give the company a strong footing in biogenerics. "We have a strong base in emerging markets like Brazil, Russia, Indonesia and Mexico. Biogenerics has an interesting proposition in these regions as they are semi-regulated markets and has no immediate barriers there," Handa pointed out. While Handa believes that making a presence in the US markets might not be a cakewalk for them, finding a pathway there still remains on the cards. "The US is a potential market but we want to wait and watch how the US regulatory markets open up," Handa said. The European market is restricted only to a few companies and it is a very expensive process. The company also intends to export erythropoietin to these countries. "We are basically targeting emerging markets and then as and when the regulatory markets ease out, we will then take a call on how to penetrate the regulated markets of the US and Europe independently or partnering with somebody," he informed. In addition to being a critical care company, therapeutic areas has always been a favorite exploration ground for Claris with its special focus on oncology and nephrology. "We have a strong base in nephrology and we recently entered oncology, which is considered the sunrise industry. We are using these two platforms to foray into biotechnology and launch our biotech products. These may be further stretched to launch other innovative products," confirmed Handa. The company also intends to foray into biopharmaceuticals as they believe that EPO and GCCF products are similar to critical care and oncology business of Claris. Apart from this, the company also has plans up it sleeves to make its presence felt in the Rs 3,053-crore ($745 million) vaccine market. The vaccine business alone registered 30.41 percent growth last year. Though not officially announced, the company claims that it sees a world of opportunities in this niche market, which accounts for 51 percent share of the total biopharma market. "Vaccine market is a lucrative space and going into this market will be beneficial for us as it is in line with our strength, that is the injectables market. Here we have the expertise, which means development, manufacturing, registration and also selling to large institutions," added Handa. However, even in this market, it does not want to get into avenues already explored and try other non- traditional areas. "One should also keep in mind that there are other areas in vaccines which is developing very fast. We want to get into a something which is technologically complex and hence very lucrative as a business proposition," Handa said. Investments and plans The company was reluctant to quantify the total monetary investments in its biotech venture. "Monetary investments is something which is intangible for us now. Four-six percent of our revenues goes to R&D and a significant part of that has been going to biotech," revealed Handa. Investments for Claris Biosciences has been in the form of manpower and infrastructure. "Biotech investments is not just about the financial aspect but also on the acquiring the knowledge base. We have initiated the biotech activity more than one and a half years ago, fortunate to get a very good team and now we are at a phase where there will be ample lab facilities up and running so the plan keeps expanding," added Handa. Currently, the investment for Claris has been more on the time spent to understand the market in knowledge applications namely positioning an experienced team, setting up a the building to commence the biotech facilities. Starting with the short-term objectives of buying of the shelf technology wherever available, in-licensing technologies, developing non-infringing process technology, and a focus on drug molecules coming off patent, as well as product development in collaboration with other partners, in the long run Claris Biosciences intends to get into a discovery and research led growth strategy. As far as long term plans are concerned, biotechnology will be used as a platform to foray into other related areas like vaccines â€“ plans for which are still in its preliminary stages. Similarly, in oncology there would be an innovative platform as such combining biotech with other niche areas. "We are evaluating those platforms. However, since we do not have a global strategy, we have not declared the model though we have started work on some of them," Handa disclosed. The company has divided its investment plans into three phases. The first is the setting up of the lab facilities and getting the product level and the next phase would be setting up the manufacturing front and the third phase would be commercially producing the biotech product. Stage two, which is product manufacturing would again be divided into two phases. The first phase being the GcMP pilot plan and the next phase, which would be a much later stage would be to set up a full-fledged plant. Eventually the ultimate target of the company would be investing in the R&D space. "That would be the logical step for any company getting into the biotech space. However, as of now, we are aware of our limitations since we have just got into this space," added Handa. The company is being realistic and focusing their plans and thought processes on their first phase of the investment. As far as investing in human resources is concerned, Claris Biosciences is tapping young talent. At present the employee strength is 20 but the target is to recruit another 20-25 personnel in the coming year. "We take in freshers, train them in reputed institutes depending on the kind of training that they need and fit them into our own strategy. We also train our own people and that is the best way to retain them," said Dr Gita Sharma, head-biotech, Claris Lifesciences. Targets in the coming year Monetary targets are not Claris has on its cards as it believes it is not the right approach. "We strongly believe that we are in the investment phase currently and this investment phase is a good 3-5 years. So we want to build a solid base in terms of building the capability of the company. We depend strongly on our development programs and do not happen to keep our eyes on numbers. That will happen in due course of time the focus is now on development programs and keep investing in our building capabilities," Handa said. As of now the main focus is on the initial products that they have taken, register them as soon as possible and begin sales in emerging markets by 2009-2010. Handa does not rule out the possibility of alliances in this venture though at this stage he is tightlipped about the issue. "It is a strong possibility. Biotech is a knowledge intensive space and it does not make sense to build a knowledge base on your own if you have to spend that amount of time There should be an alliance in the near future," he added. Lab facilities In line with its vision for this segment, Claris has invested in a state-of-the-art biotech laboratory, equipped for development of biosimilars, development of novel biologics, facilitation for technology transfer, biotherapeutic protein drug testing and characterization as per the US, European and British Pharmacopoeia and co-development for biotherapeutics. The company's biosciences manufacturing facility is being designed to include facilities for API manufacturing using both microbial and mammalian cell lines, for products such as Erythropoietin, G-CSF, Interferon and others, along with formulation and filling facility for finished biotherapeutic protein drugs, both in vials and PFS. "We can do all tests under our roof. We have a state-of-the-art molecular biology laboratory, a stem culture lab, a small GMP lab and everything connected to R&D. We are also putting up a state-of-the-art animal facility, we have the facilities for protein batch release, characterization and identification," added Dr Sharma. With these myriad targets in the biotech space and having had a decent share in the Indian market, Claris Biosciences intends to amalgamate its current strengths and therefore find success in their biotech venture. Nayantara Som   ]]> <![CDATA["Indian seed industry is well placed to serve both domestic and international markets"]]> https://biospectrumindia.com/news/95/2288/indian-seed-industry-is-well-placed-to-serve-both-domestic-and-international-markets.html https://biospectrumindia.com/news/95/2288/indian-seed-industry-is-well-placed-to-serve-both-domestic-and-international-markets.html Wed, 07 May 2008 11:57:00 +0530 New Page 1 "Indian seed industry is well placed to serve both domestic and international markets" -Dr MK Sharma, managing director, Mahyco Monsanto What are your views about the future of the seed industry? How do you expect to grow vis-Ã -vis the industry? The seed industry in India has been making great strides since Independence. The impetus to this was also provided by the changes that have taken place in the economic and agriculture scenario of the country and also the international environment. Globalization and economic reforms have opened new opportunities with many challenges. The Indian seed industry is well placed to serve both domestic and international markets. The seed industry is now in a position to meet the demand of diverse agro-climatic conditions and intensive cropping systems. The ever-increasing demand for agriculture products can only be met by sustained increase in production and productivity to which new and improved variety of quality seeds contribute to a greater extent. The Indian seed industry is now in a better position to face such challenges by investing more in research and development programs, use of biotechnology, acquisitions, mergers and collaborations with like-minded research companies to bring synergy, addition of new range of crops, products and technologies and also value-addition to the existing crops by traditional methods. From here biotechnology will play an important role in agriculture development through transgenic seeds. It holds great promise in developing crop varieties with higher level of tolerance to biotic and abiotic stresses and nutritional enhancement. Bollgard (Bt) cotton the first and presently the only Indian transgenic crop is one of the best example to prove such claims. For the growth of seed industry, what are key levers, critical issues and blockers? For smooth growth of the seed industry, it is a must to remove road blocks like: Equal treatment for public and private sector in matters like subsidy on seed Protection through regulation to technologies developed by private sector from unauthorized use. There should be a science-based and less time consuming regulatory system for the release of transgenic crops. Also commercial decisions like price and packing should be the prerogative of the inventor only. The seed industry should be treated at par with other similar agro-based industry in all taxation matters including income tax. How is the whole process of seed production, processing and quality control monitored? The monitoring of seed quality is a long drawn continuous process which starts from breeder seed, foundation seed to hybrid/varietal seed production and continues through seed processing and finally packing and its storage. At every step, strict monitoring is done by technically qualified seed production and quality control supervisors, by visiting the seed production field at specific stages of seed crop to ensure that there is no contaminant in the field or in required isolation area. Seed from only those production fields, which meet the required field standards during the crop season is accepted for processing. Prior to and after processing the samples are drawn for various tests namely genetic purity, germination, vigor and physical purity. In case of transgenic crop, test for the presence of trait is also carried out. Seed lots declared pass in all above referred tests are finally packed and dispatched for distribution. Lots which fail to meet the required standard in any one or more tests are declared as unfit for use as seed. Seed processing is carried out at the company's own seed processing plant located in various states, in close proximity to seed production areas. The processing plants are well equipped with imported, efficient and high capacity seed processing machines How is the company able to withstand the competition from other players? Mahyco strives to provide quality seeds. Since its inception it has been engaged in plant genetic research and production of quality seeds. Currently it is engaged in developing genetically enhanced crops with the use of gene transfer technology. Mahyco is the first company to commercially grow and market the transgenic Bollgard (Bt) cotton â€“ India's first transgenic crop in 2002. Presently Mahyco scientists are busy in genetically modifying cereal and vegetable crops to infuse them with novel traits such as resistance to drought, herbicide, sucking pest and nutritional enhancement. Nayantara Som   ]]> <![CDATA[The politics of GM food]]> https://biospectrumindia.com/news/95/2891/the-politics-of-gm-food.html https://biospectrumindia.com/news/95/2891/the-politics-of-gm-food.html Wed, 07 May 2008 11:07:00 +0530 New Page 1 The politics of GM food Kirit S Javali, advocates@jafajavali.com Law Offices of Jafa & Javali is a full fledged corporate law firm with niche expertise in IPR & Biotech law, with offices in New Delhi, Bangalore and Mumbai Genetically modified crops have been at the center of controversy for quite some time now, both nationally and internationally. Despite a fair amount of debate and discussions, no consensus appears to be in sight. Understanding agricultural history is a good starting point in allievating people's unease about GM foods. Humans have been modifying crops for thousands of years, and without human care many of today's crops would cease to exist. Globally, the US and Canada are all for genetically modified crops, while the European Union is not. In India, it is still early to say whether genetically modified food would be fully accepted. The process of introduction of genetically modified food involves a series of field trials before it is released for commercial use. GM food generally raises the concerns of environmental issues, right to information, and biosafety regulations Environmental issues One major concern is that genetically modified seeds, which have been engineered to insecticide or herbicide resistance, may escape into the wild and therefore, may endanger biodiversity. Proponents of transgenic crops argue that these crops requires much less herbicides and insecticides and are therefore, more environment-friendly. Nevertheless, scientific research aimed at risk analysis, prediction and prevention, combined with adequate monitoring and stewardship, must continue so that negative ecological impact from GM crops will be kept to a minimum. Most problems raised by science can be solved by science itself. Right to Information Societal acceptance is essential to the continued development and application of biotechnology in food and agriculture. The issue for consideration is whether GM food can endanger health and whether the consumer should have the right to have detailed information through proper labeling so that they can decide rationally whether they should buy such GM foods. The purpose of labels is two-fold: they contain the nutrition information and they warn against presence of allergens. The EU and Japan are both in favor of giving GMO related information on product labels on a mandatory basis. The EU had introduced a Regulation (EC) 258/1997 and Regulation (EC) 50/2000 of the European Parliament, which makes the labeling of foods containing GM additives and flavorings mandatory. The US and Canada are opposed to mandatory GMO labeling, due to any possible adverse public reaction to their GMO-based product exports. Bio-safety regulations In the US, three government agencies namely the Environmental Protection Agency, United States Department of Agriculture, and the Federal Drug Administration are responsible for commercializing GM foods. In the European Union, the approval for commercialization of GM foods consists of a process outlined by Directive 90/220/EEC on the release of GMOs into the environment. In India, the planting of GM crops is a regulated item. These crops can be planted only in the open fields with the prior permission from the Department of Biotechnology (DBT), which is under the Ministry of Science and Technology. A number of committees are involved in the regulation of GM crops. The Indian government first issued rules and procedures for handling GM organisms in December 1989 by way of The Hazardous Micro-Organisms and Genetically Modified Organisms Rules, 1989 under the Environment Protection Act, 1986 (EPA). Guidelines for Safety in Biotechnology were laid down by the DBT in 1994 which describe the bio-safety measures that must be undertaken in India both for contained research activities and also for large-scale open environmental release of genetically altered agricultural and pharmaceutical materials. A subsequent 1998 revision of the guidelines elaborated procedures for screening transgenic plants and seeds for toxicity and allergenicity. India's crop biosafety guidelines were written to require a screening of GM crop technologies for scientifically demonstrated risks. The guidelines create two separate review committees: a Review Committee on Genetic Manipulation (RCGM), which is empowered to approve (or not approve) applications for all small-scale research activities in India designed to generate information on transgenic organisms, and a Genetic Engineering Approval Committee (GEAC) empowered to approve (or not) large scale research activities, plus actual industrial use or environmental release of all GM organisms. The GEAC is thus India's most powerful biosafety policy gatekeeper. It is the lead inter-ministerial body empowered to shape by consensus - the government's final disposition toward large-scale use and environmental release of GM organisms. The GEAC is empowered to authorize or prohibit, conditionally or unconditionally, the import, export, transport, manufacture, processing, use, or sale of any GM organism. Therefore, the GEAC requires that in the area of GM plants, basic information must be provided through lab, growth chamber, greenhouse and field trials and evaluations must be generated by applicants regarding toxicity and pathogenicity, possibility and extent of transgenic pollen escape and transfer to wild relatives, and consequences for both the environment and human and animal health. Viewpoint As mentioned above, the Genetic Engineering Approval Committee (GEAC) is a body appointed by the Ministry of Environment and Forests and is the regulatory body assigned to monitor the manufacture, use, import, export and storage of hazardous micro-organism and genetically engineered organism and cells. It is also responsible for granting commercial approval of proposals relating to the release of genetically engineered organisms and products into the environment, including experimental field trials. An important point for consideration which has arisen in recent times, in relation to the field trials which have been conducted by companies is whether the field trials conducted by the companies and data collected by the authorities in respect of Bt cotton or in respect of proposed genetically modified food products such as okra and brinjal should be released under the Right to Information (RTI) Act or should the commercial interests of the companies be protected or for reasons of public health, whether the information should be released remains a matter to be decided. It is argued that companies involved in research and development (R&D) spend a considerable amount of time and money on innovation of new products. It is further added that the disclosure of the biosafety information of transgenic crops will affect the commercial interests of the company. For, biosafety data falls under the protected confidential information covered by the Trade Related Aspects of Intellectual Property Rights (TRIPS) regime and is to be considered an intellectual property of the company. In any event protection available under Intellectual Property laws requires them to disclose the information publicly and later grants them exclusivity for a very limited period of time. Welfare groups have been seeking details of the safety test conducted by the companies who have been granted commercial approval and to bring the data in the public domain from the concerned authorities. It is argued that the data being sought is not for commercial purposes but to ascertain the risks that transgenic crops pose, particularly when open air field trials are being conducted in several places across the country. It can be argued that once the authorities have granted the regulatory clearance for conducting trials and commercial license has been granted after proper scrutiny then in such an event genetically modified products pose no threat to health hazards. The Act permits the government to refuse disclosure of data, which exempts from disclosure information, including commercial confidence, trade secrets or intellectual property, the disclosure of which would harm the competitive position of a third party. (Section 8 (1)(d) of Act) The object of the Act is to provide for setting out the practical regime for citizens to secure access to information under the control of public authorities, in order to promote transparency and accountability in the working of every public authority. It can be argued that public health should not be compromised at any cost, however, if information has been submitted to respective committees which are designated by the government of India for appropriate review and analysis under the appropriate rules and regulations prescribed, then the company's data should not be released unless a company has bypassed or concealed any vital information which may have bearing on public health or the products prove to be otherwise, then in that event, data should be released and the matter must be investigated to its logical end. Disclosure of information has to be balanced with preservation of confidentiality of sensitive information and protecting the interest of the public. How this can be achieved remains to be seen since the facts and circumstances in every case is different.   ]]> <![CDATA[An enforceable international compact for infectious diseases]]> https://biospectrumindia.com/news/95/1465/an-enforceable-international-compact-for-infectious-diseases.html https://biospectrumindia.com/news/95/1465/an-enforceable-international-compact-for-infectious-diseases.html Wed, 07 May 2008 10:51:00 +0530 New Page 1 An enforceable international compact for infectious diseases Prof. Harvey Rubin is a professor of medicine, microbiology and computer science, and the director, University of Pennsylvania Institute for Strategic Threat Analysis and Response. (rubinh@mail.med.upenn.edu) Prof. C Kameswara Rao is the executive secretary of the Foundation for Biotechnology Awareness and Education (FBAE), Bangalore and a member of the Committees of the US National Academies of Science and the WHO on dual use life science technologies related to global health security. (chaakaaraav@yahoo.com) Human beings have raced with pathogens but always lagged a few steps behind in combating them. In the 21st century, it is an arms race, not between states, but between the global community and naturally occurring pathogens. A very potential new threat emanates from dual use of life science technologies, involving nefariously disseminated pathogens. Endemic, epidemic and pandemic infectious diseases now threaten global health and international security, and this requires global responses to track, detect, prevent and treat infectious diseases. The reports of the US National Intelligence Council (2000) and of the US Institute of Medicine (2003) brought into focus the threat to global health security from microbial agents. A document of the US Central Intelligence Agency (CIA) (2003) analyzed "The Darker Bioweapons Future" and concluded that "the effects of engineered biological agents could be worse than any disease known to man". The US National Security Strategy cautions that "public health challenges like pandemics (HIV/AIDS, avian influenza) recognize no borders" (2006). The risks to social order are so great that "traditional public health approaches are inadequate, necessitating new strategies and responses." The Infectious Diseases Society of America observed that "in a growing and frightening number of cases, the pathogenic bacteria are resistant to many approved drugs, and patients have to be treated with new, investigational compounds or older, toxic alternatives." A report of the Woodrow Wilson School of Public and International Affairs (Princeton University) warns that "new diseases and antibiotic-resistant strains of old ones are on the rise". Deliberate misuse of emerging technologies The deliberate spread of infectious diseases misusing otherwise beneficial life science technologies has emerged as an attractive option for bioterrorists which is now a major global security concern. The issue of dual use of beneficial research and technologies has been discussed in depth, by such international Committees and Working Groups as the two Committees of the US National Academies, one on "Biotechnology Research in the Age of Terrorism" (2002-2003) and the other on "Advances in Technology and the Prevention of their Application to Next Generation Biowarfare Threats" (2004-2005), World Health Organization's (WHO) Special Working Group on Life Science Research and Global Health Security, that has been meeting at different places since October 2006, the US National Institutes of Health and WHO's International Round Table on Dual Use Life Sciences Research (February 2007), the Organization for Economic Co-operation and Development's (OECD) High Level Forum on Medicines for Neglected and Emerging Infectious Diseases (June 2007) and the 2nd International forum on Biosecurity (March 2008). Socio-economic impact of infectious diseases The predominance of infectious diseases has an undeniable moral significance and highlights our collective failure to give this problem, with implications for the economic well-being of both the developed and developing world, the attention it deserves. The significant role infectious diseases play in the perpetuation of poverty in the developing world is well recognized. They destroy family structures, and limit economic and educational opportunities affecting the economic security of all nations. While the social disintegration that follows an epidemic is known to sections of general public, the consequent economic disruption is far less known. A few weeks after the identification of the Severe Acute Respiratory Syndrome (SARS), the disease had already cost nearly $30 billion, an amount sufficient to prevent eight million deaths from infectious disease worldwide. A potential H5N1 pandemic costs much more, with economic losses approaching $600 billion in the US alone, depending on the virulence strain. The spread of pathogenic bacteria that are becoming increasingly resistant to the existing antibiotics imposes a persistent cost in terms of both health and currency. Lessons from the past Over the past 25 years, there have been several successful efforts at resolving complex and sometimes overlooked international issues, from the perspectives of both implementation and end-stage achievements. Six NGOs who met in October of 1992 in New York founded the International Campaign to Ban Landmines (ICBL). Five years later, the international "Convention on the Prohibition of the Use, Stockpiling, Production and Transfer or Anti-Personnel Mines and on Their Destruction" came into force and the ICBL was awarded the Nobel Peace Prize "as a model for similar processes in the future". The essential issues surrounding infectious diseases possess similar normative force, which hopefully indicates a similar potential for progress. The efforts of the Consultative Group on International Agricultural Research (CGIAR) resulted in a massive increase in cereal yield in the second half of the 20th century, averting a global food crisis. CGIAR is an important antecedent combining North/South representation with innovative research and a truly lasting impact in some of the poorest regions in the world. The magnitude of the threat of infectious diseases similarly necessitates a major global, investigative effort. The lasting positive impacts of international research centers are many, including fostering long-term relationships between scientists, establishing a culture of research responsibility and serving as the nucleus for safe applications of interdisciplinary sciences globally. The key to any progress against infectious diseases is a structure that brings together diverse interests in a lasting manner. Without such a structure, the commitment to reducing the impact of infectious diseases on our national, economic and personal security will be subject to the political vagaries of the moment, leaving us unprepared for any health crisis. The daunting realities Each year 300 million cases of malaria kill two million people; An estimated three percent of the world's population are chronically infected with hepatitis C virus, with about four million newly infected each year, 80 percent of whom will progress to a chronic infection associated with cirrhosis (about 20 percent) and liver cancer (about five percent); Of about two billion people infected with hepatitis B virus, some 400 million are chronically infected and one million people die each year from hepatitis B and its complications; One third of the world is infected with tuberculosis with 10 million new cases every year accounting for two million deaths; Approximately 50 million people worldwide are infected with HIV, which killed 3.9 million in 2005; and Despite the attention given to diseases like HIV/AIDS and avian influenza, some outbreaks are still relatively unknown to the general public yet represent a serious burden on global health. Cholera, for example, still causes about 120,000 deaths per year. International compact for infectious diseases Considering the general threat scenario of natural and deliberate spread of infectious diseases and the international consensus on preparing to face the threats, Prof. Harvey Rubin has developed, with intellectual inputs from over a score of active microbiologists and pathologists mostly from North America and Europe, the "International Compact for Infectious Diseases", with a four-point strategy for handling threats from infectious diseases: Compact core mission I: Establish, maintain and monitor a shared international data and knowledge base for infectious diseases, including but not limited to biosurveillance information, relevant pharmaceutical data and suites of services and skills. Compact core mission II: Establish, maintain and monitor a network of international basic science research centers that will support fundamental investigations into the pathophysiology of certain microbial threats to global health. Compact core mission III: Expand capabilities for the production of vaccines and therapeutics expressly for emerging and re-emerging infections. Compact core mission IV: Establish, maintain and monitor international standards for best laboratory and regulatory practices. IT Architecture The Information Technology Architecture proposed for the Infectious Disease Compact will seamlessly integrate most of the existing databases, make them user friendly, yet provide the necessary security and add new data as recommended by the wide user community. Though the challenges here are formidable, they are hardly insurmountable. The greatest obstacle is the need for trust between signatory nations and a willingness to share data. There are technical challenges as well. Any attempt to create a common architecture for information systems would require common ontologies. New algorithms and models of disease spread have to be developed and validated. Lastly, the language of the compact has to address the issue of member states, which do not report, or significantly under-report, the incidence of communicable diseases. Anticipated benefits The compact is expected to afford the following benefits to signatory nations from both the developed and developing worlds: Provide access to cheaper, more highly standardized specific therapeutics and vaccines that are relevant to the signatories; Ensure better quality control of vaccines, therapeutics and diagnostics in the developing world, leading to fewer expired or counterfeit agents; Provide access to and participation in high-level research; Provide developing and developed states with a voice in the direction of R&D Distribute the costs and risks of research and development across a number of countries; Provide more complete datasets on emerging infections and potential pandemics; Create a more competitive market for vaccine and therapeutic development targeting diseases of relevance to signatory nations; and Enhance and enable human health and well-being, economic development, and basic biological research. For these benefits, it is urgent to make accelerated efforts to draft, debate, refine and implement the first International Compact for Infectious Diseases. Treaties, conventions and comprehensive compacts There is no comprehensive program for infectious diseases and the Biological Weapons Convention (BWC) is inadequate. While international treaties and conventions have some advantages like providing for an international legal basis for enforcement, creating a body of durable "hard law" around an issue and drawing on the power of governments to regulate and license within their jurisdiction, the drawbacks are that ratification is slow and may limit action on urgent issues and the states may perceive enforcement clauses as an unacceptable burden, or even as a threat to their sovereignty. While compacts have the benefits of being effective governance structures that are quick to set up and provide a framework for action, bring together a broad coalition of partners around a central issue and promote voluntary compliance of laboratories, companies, etc., they suffer from such drawbacks as that enforcement relies on soft power and voluntary compliance, which may prove ineffective during a health crisis. The answer is a "Comprehensive International Compact for Infectious Diseases", a two-pronged approach with the states as the eligible parties and ratification as the method of participation. Treaty and compact are complementary systems that provide for parallel frameworks for different parties, the overall project will, over time, achieve the benefits of each. Domestic partners who are signatories to the compact can pressure states to comply with the treaty. Several compact-like international agreements exist in such areas as human rights, environment, arms control and disarmament, and trade and finance. Legitimacy and understanding of the overall system will be promoted through involvement of both the state and non-state actors. Implementation of the four core missions of the compact will minimize the impact of infectious diseases on global health, social and economic development and international security. The compact drives innovation and progress in four core areas: information and knowledge sharing, basic science, drug and vaccine development and best laboratory and regulatory practices. These missions are interconnected. Without a strong foundation of basic science, the drug and vaccine pipelines dry up. Similarly, in the absence of effective biosurveillance, it becomes difficult to project which strain of an emerging disease represents the most significant threat, which in turn hampers our ability to create countermeasures. Information technology and knowledge sharing will drive new science, which in turn can modify and inform regulatory initiatives. Standardized regulatory regimes enable new drugs and vaccines that will change global epidemiological patterns and these patterns must be reintegrated into a central database, beginning the cycle again. Addressing the problem as a whole creates powerful incentives for stakeholders to participate. For example, in order to access a central database containing information on current clinical trials, epidemiological data and new compounds and targets, participants would pledge to implement best laboratory and regulatory practices. By bringing together government, the private sector and academia, the compact allows each group to institutionalize their relations with the others. Pharmaceutical companies and public-private development partnerships can find partners to help take promising leads through to development. With the inclusion of post marketing/post distribution clinical trial data in the database, philanthropic organizations and governments will be able to understand the effects their investments are having throughout the world. Academics will acquire additional funding streams for their research as well as input from their colleagues all over the world. Finally, all parties will work together to harmonize regulatory processes across the board, reducing barriers to market entry for much needed therapeutics and ensuring their wider distribution. International biosurveillance and reporting International biosurveillance and reporting faces certain challenges, particularly at the level of sophistication envisioned in the compact, which include: Integrating current initiatives into a national health IT strategy and federal architecture to reduce the risk of duplicative efforts; Developing and adopting consistent interoperability standards; Creating an open architecture that maximizes the use of off-the-shelf tools; Creating enough flexibility to bring together disparate underlying IT languages and technologies to provide a common operating picture; Generating the ability to accept multiple data formats used by agencies that provide the biosurveillance information; Generating the ability to feed information back to the originating agencies providing biosurveillance information in a format each agency can accept; Identifying data flows that will evolve during the developmental process; Allowing the methods of analysis to evolve and adapt as new data become available or existing data sets are improved; and Knowing and evaluating the effectiveness of the current underlying algorithms, methods, and structures for biosurveillance data analysis. Organization and governance In order to accommodate the various interested parties and work within the limits of international law, the compact will embrace a two-pronged approach, working with states in the form of a treaty and with other interested parties (NGOs, academic institutions and the private sector) as a softer, pledge-based agreement. By providing parallel frameworks for different parties, the overall project will achieve the benefits of each. Domestic groups that pledge their membership can apply pressure to their home states, hopefully speeding ratification of the treaty framework. By bringing together both state and non-state actors, the overall aims of the compact will be debated from a variety of different viewpoints, thereby enhancing the legitimacy of the project and promoting a thorough understanding of its goals.   ]]> <![CDATA[Valuation of patents: science or magic?]]> https://biospectrumindia.com/news/95/1764/valuation-of-patents-science-or-magic.html https://biospectrumindia.com/news/95/1764/valuation-of-patents-science-or-magic.html Wed, 07 May 2008 10:29:00 +0530 New Page 1 Valuation of patents: science or magic? Dr Ralf D Kirsch, Dr Christof Keussen and Dr Thomas Westphal are patent attorneys and partners in the IP law firm GLAWE DELFS MOLL in Germany (Hamburg, Munich, www.glawe.de). atents are rights, which allow the patentee to exclude competitors from the commercial use of the patented technology or to allow this use only in exchange for the payment of a license fee. No doubt patents have a value. But what value is that? The answer to this question is becoming increasingly important in knowledge-based economies and sectors, such as the biotech sector in India. The value of companies is more and more shifting from material towards so-called immaterial assets to which also patents belong. However, there simply is no commonly accepted method available yet to determine the value of a patent. The absence of such common methods to determine the value of a patent is making it more difficult for small and medium-sized innovative biotech companies in the founding and growth phase to get the funding they need in order to continue to grow. The value of such companies is often based to a considerable extent on the Intellectual Property (IP), and therefore also on patents and patent applications of the company or its founders. Negotiations with potential investors or other capital providers would certainly be easier if such company could assign a defined value to its patents that has been determined by a commonly accepted method. In addition, valuation of a portfolio of patents and patent applications can also be important in the M&A business, e.g. if one biotech company wants to acquire another company that has an existing portfolio, which is also to be acquired. No market price for patents The value of an economic asset in a free economy is determined by free price generation in the market. If there is a liquid market for a given economical good the determination of its price is continuously happening, which allows participants of the market to determine the value of their own comparable assets. The direct comparability between the corresponding assets is, however, of vital importance for the determination of the value according to market prices that have actually been paid. Such comparability is there for commodities or other mass goods of the daily need. Here, liquid markets exist with a daily price determination, which allow for a rapid determination of the value. The lower the comparability of the goods and the lower the liquidity of the market, the more difficult is the price determination. Even when offering daily goods such as cars or property, one can have the painful experience that the own view of the price cannot find much interest in the market. It is obvious that patents are unique-even more so than e.g. property. A comparability is hardly there. The market is less liquid and, at the foremost, less transparent. Selling and licensing of patents is happening, but the information on prices actually paid usually stays behind closed doors. Therefore, a determination of the value of a patent by actually paid market prices is usually not possible, or at least very difficult. Plans for standards At least in Germany, the valuation of patents is going to be subjected to defined standards. In February 2007, the German Industry Norm DIN PAS1070 "basics of proper patent valuation" has been published. In November 2007, a DIN board was formed to work on the basics and standards for patent valuation. In Germany, patent valuation has therefore made quite a bit of the way from magic to science. A modernization of the German balance law, that is about to take place, is surely going to speed up the further development towards commonly accepted standards for valuating patents. For Indian biotech companies it is important to remember that patents can be looked at as an important commercial asset, the value of which can be determined. In takeovers or mergers of biotech companies the value of a given patent portfolio somehow needs to be valuated. At least in Germany, the standards for determining the value of patents â€“ be it a German national patent or the German part of a European patent (Europe direct or PCT) â€“ are developing in a promising way. Different approaches for valuation Since reliable market prices as an important indicator for the value of a patent are missing, the daily practice has formed other approaches for the valuation of patents. Cost approach: The cost approach is based on the idea that the costs for the development, the filing and the maintenance of a patent reflect its value. The cost approach comprises direct costs for obtaining the patent as well as indirect costs, such as the R&D costs, which can be quite substantial in the biotech and pharmaceutical sectors. However, the costs for creating the patent are usually not related to its potential future economic benefit that can be gained with the patent. Unfortunately, huge efforts in R&D and patenting do not necessarily guarantee obtaining patents of high commercial value. Market approach: The market approach tries to make an analogy to known transactions of comparable patents that have already been made in the past. The valuation is made according to assumed adequate market prices that have been achieved in transactions of comparable patents between third parties in the market. The market approach is vitally dependent on the reliability of the data on which the comparison is based on. Since there is no active and transparent market for patents, such comparable data can hardly be obtained. An additional problem is that there is simply no general comparability of patents, patent transactions and companies involved in that. In practice, there are attempts to create an almost complete comparability by so-called "indicator models". Here, patent transactions that have been published by the parties are analyzed and various data on the patent that can be looked at statistically are determined, such as the number of the claims and the number of inventors. Subsequently, a correlation is made between these patent indicators and the price that has been paid in the comparable transaction. It is assumed that, in practice, a given patent with similar indicators can achieve a similar price in the market. However, there is no model yet that can be looked at and examined by everybody. In as far as models exist they are simply not published by the developers. Profit approach: The profit approach tries to forecast the future economic benefit of the patent over an adequate period of time and to discount the interest of the thereby generated future cash flows on the current value in cash (Discounted Cash Flow Method). When determining the profit a patent can usually not be looked at in an isolated way. In a first approach, a patent is only a right to exclude third parties from using a protected technology. In order to create from this right a commercial benefit, complementary goods are needed, such as production means, access to a market etc. A potentially valuable patent can have a low profit if it is in the hands of a company that has no or insufficient means to actually use the patent. The so-called "Value in Use" is determined based on the assumption that the patent to be evaluated is kept and used and commercialized by its current proprietor. The existing complementary goods of this proprietor are known. The "Value in Use" determined in this way can be an important indicator for a potential investor that wants to invest e.g. in a start-up company. The so-called "Transfer Value" of a patent assumes that the patent is sold and, as the case may be, used by a third party. It can be substantially lower than the "Value in Use" and can be important especially if a patent is to be used as a security for a loan. One advantage of the profit approach is its transparency and its traceability. Moreover, in practice, there is quite a body of experience with the profit approach, such as the determination of damages in a patent litigation trial or the determination of an adequate compensation for an employed inventor. About the authors Dr Ralf D Kirsch studied biology in Konstanz, Germany, and went into research in molecular biology and cellular and molecular immunology at the University of Cambridge, UK, where he did his PhD. After his science period in Cambridge, he did a postdoc at the Max-Delbrueck-Centre for Molecular Medicine in Berlin, Germany, also in the field of cellular and molecular immunology (kirsch@glawe.de). Dr Christof Keussen studied chemistry at the University of Kiel and did his PhD there in the field of chemical physics. He is predominantly active in the field of patent law, where the representation before the EPO as well as in patent litigation and nullity suits are the major focus. He is a member of the Board of the German Chamber of Patent Attorneys as well as in the DIN board for patent valuation (keussen@glawe.de). Dr Thomas Westphal studied biology in Moscow and spent years in research in genetics, molecular biology and biochemistry at the Lomonossow University in Moscow as well as at the Martin Luther University in Halle, Germany. He is active in the field of patents and trademarks.   ]]> <![CDATA["Indian science in genomics has been able to place itself on the global map"]]> https://biospectrumindia.com/news/95/2799/indian-science-in-genomics-has-been-able-to-place-itself-on-the-global-map.html https://biospectrumindia.com/news/95/2799/indian-science-in-genomics-has-been-able-to-place-itself-on-the-global-map.html Wed, 07 May 2008 10:23:00 +0530 New Page 1 "Indian science in genomics has been able to place itself on the global map" -Dr Samir K Brahmachari, Director General, CSIR, Delhi These are exciting times for Indian science. India is all set to play host to the 13th human genome meeting in September this year. The excitement is already palpable since it not only happens to be the 20th anniversary of the Human Genome Organization (HUGO), but it is for the first time that the Human Genome Meeting is being held in India. India has also submitted data on the Indian genome variation that has been published in the Journal of Genetics, (Vol.87, No.1, April 08) . In a chat with Dr Samir K Brahmachari, Director General, CSIR, BioSpectrum finds out more about HUGO and the buzz about the human genome meeting in India. Incidentally, Dr Samir Brahmachari will be delivering the special address during the CEO conclave at Bangalore Bio 2008 on this topic. Excerpts: What is the objective of HUGO and when was it formed? The Human Genome Organization was formed at the very beginning of the human genome project with an idea that this will be the forum where information will be shared across the world without any restriction of geographical boundaries. This is an organization by the scientists, for the scientists all across the world, in order to disseminate the human genome information to the world, to make available the human genome sequence in the public domain so that everyone has equal access to it. HUGO has played a very important role in not only making the human genome sequence open source and publicly available, but also making the knowledge available and also addressing the ethical, social and legal issues that would concern the society. As per its policy, five percent of its fund utilized for research is used to address ethical, legal and social implications of the human genome sequencing that were understood as early as the 1990s. The human genome project was initiated in the late 1980s under the funding of the Department of Atomic Energy (DAE). HUGO was formed as an organization in Switzerland wherein HUGO US and Moscow were associated members. In 1990, I was the one of the early members elected to HUGO along with Prof. Notani of BARC from India with 100 odd scientists. The original objective of HUGO was to coordinate the mapping of the genome. So the human genome mapping workshop was initiated. And it was only in the late 1990s when the mapping was completed, that the Human Genome Meeting was actually started . So in this series, we shall be hosting the 13th Human Genome Meeting in India in Hyderabad from September 27-30, 2008. Please elaborate on the Human Genome Meeting (HGM) being held for the first time in India. In the beginning HGM was held for a year in Europe and then in the US. It was only in 2002 that the HGM came to China for the first time. This was because China participated from the developing world in the human genome sequencing project from 1999-2001. Japan has been a major player along with the US and Europe and hence recognizing this, the meeting came back to Asia again, in 2005 in Japan. This is the third time the meeting is coming to Asia and this time it is India. We have chosen Hyderabad for the meeting, since it has one of the best convention centers in the country where a meeting of such a global stature can be held. How do you see the significance of the meeting coming to India? This signifies the contribution that India has made in genomics by developing the Indian genome variation landscape. This is something unique because this is the first time that 55 populations across a country have been mapped for various gene risk alleles. This signifies that Indian science in genomics has been able to place itself on the global map. Accepting to hold the meeting in India and directing me to chair is the recognition of this. What are the key features of the meeting? We are expecting a participation of 500 students in the meeting. We are organizing special satellite meetings, a "Know your Genome" meeting for students to make them aware of the human genome, and a clinical genomic workshop for clinicians amongst others. The meeting also aims to address the ethical and legal issues associated with the human genome. We are also thinking of a session on the business of genomics and new biology for young entrepreneurs. There will be an exhibition of new instruments and technologies as well as many presentations on technological aspects as well. It will be a platform to showcase the Indian industry to the world. Besides, people will get to see and listen to the who's who of genomics, such as Craig Venter. What are your expectations from the meeting? When I was young and molecular biology had just come, we hardly had any resources, capabilities or access to information. Today this new biology is bringing to the fore the champions working at the frontiers. I want to expose Indian scientists to them and make them realize that things are not difficult for us and that India is no longer behind. This would enable them to think bigger. The Indian genome variation study uses disease markers instead of neutral markers. Kindly elaborate. Certain areas of the genome are neutral under natural selection, so if one wants to know who is related to whom and how are different populations related, neutral markers would provide the requisite information. But we realized that our objective was to find how various disease gene risk alleles are distributed in the population, which is why we used disease markers. What are the advantages of using disease markers in the study? This helps us get background control information so that we know what is the general variability across the population, if a disease is high risk or low risk and thus helps us address the stratification problem. Second, it also helps us understand how the drug responds across different populations, to see how some drugs which may not be working in the Japanese population may not be working in the North-East region but might work in the southern region of India. Thereby India can have a low cost drug in the market using pharmacogenomic principles. What it demonstrates is that irrespective of using markers, which are disease linked markers, we are able to cluster the Indian population into four major clusters. It has further been revalidated. It is interesting to note that both the neutral marker and the disease markers could reasonably segregate the population. The study also found that despite linguistic variability, there is enormous genetic heterogeneity across the Indian population. Shalini Gupta   ]]> <![CDATA[Indian gene decoded]]> https://biospectrumindia.com/news/95/2364/indian-gene-decoded.html https://biospectrumindia.com/news/95/2364/indian-gene-decoded.html Wed, 07 May 2008 10:10:00 +0530 New Page 1 Indian gene decoded The largest ever study to understand the genetic diversity of India's one billion people by a team of top genetic experts has thrown up some interesting data and concludes that India has one of the most genetically diverse populations in the world. BioSpectrum analyzes the highlights of the study, which has been published in the April issue of the prestigious Journal of Genetics, published by the Bangalore-based Indian Academy of Sciences. The world's second largest country in terms of population, teeming with over 1.1 billion people, next only to China's 1.4 billion, was treated as a genetically homogenous place, and referred simply as the "Indian" population. A rigorous scientific study has indicated that it is not so. "Our study reveals a high degree of genetic differentiation among Indian ethnic groups and suggests that pooling of endogamous populations without regard to enthno-linguistic factor will result in false inferences in association studies," said Dr Samir K Brahmachari, one of India's leading geneticists who led the study under the aegis of the Indian Genome Variation Consortium. Dr Brahmachari is also the director-general of the Council of Scientific and Industrial Research (CSIR), which runs a chain of 38 publicly funded research institutions in India. The study, conceptualized by Dr Brahmachari and Dr Lalji Singh, who heads the Center for Cellular and Molecular Biology (CCMB), Hyderabad, included 32 large populations of sizes above 10 million people and 23 isolated tribal populations. Together, these groups represented the vast ethnic, linguistic and geographical diversity of India. Unveiling the findings of a study titled, "Genetic Landscape of People of India: A Canvas for Disease Gene Exploration", Kapil Sibal, India's minister for science and technology and earth sciences, said that the study led by Dr Brahmachari, was the largest scientific endeavor in the field of biology after green revolution. "The objective was to create a basal data for disease profile and not to map genetic diversity. This is the first time anywhere in the world that a single country has been mapped to this extent", added Dr Brahmachari. The Indian Genome Variation Consortium, a CSIR network project was started independently in 2003 after it was decided that 45 samples cannot represent the total diversity of India to build the next generation map of human genome initiated by the International HapMap Consortium. "India represents a global genetic mosaic in its population," said Sibal. "The Indian population forms a continuum of genetic spectrum that not only bridges the Caucasians and Oriental Asians and also includes indigenous populations derived mostly from Austroasiatic and Dravidian speaking population." he added. "This means that now clinical trials to test the efficacy of drugs on all major populations can be conducted in India itself given such a spectrum. The results will be used to take up further scientific studies to generate data on the nature and extent of variations related to a large number of genes and identify genomic regions related to susceptibility to specific diseases and response to drugs. The study, largest of its kind done on Indian population, included 1871 people from diverse groups, with 1,240 men and 631 women. It has been found that there were no clear geographical groupings of people in India. However, ethnicity or being tribal or non-tribal and languages seems to be the major defining factors of genetic affinities between the populations in the country. This assumption, earlier concluded by other scientific studies analyzing blood group, serum protein and enzyme loci, has been validated by the genomic study. India's vast population has evolved historically with different evolutionary histories and with multiple cultures. The earliest humans were estimated to have reached the north-western part of the Indian sub-continent nearly 70,000 years ago and then moved southward towards Sri Lanka in the next 20,000 years. There were further migrations into eastern India from Myanmar some 4,500 to 11,000 years ago. Broadly Indians belong to four major language-speaking groups: Austro-Asiatic (AA), Tibeto-Burman (TB), Indo-European (IE) and Dravidian (DR). Over 80 percent of the practice the distinct Hindu religion and 8 percent of the nation's population comprise ethnic tribals or indigenous people, spread across the country. Almost all the major regions of the world such as Islam, Christianity, Buddhism, Jewism, Zoroastrianism are followed by the people. As a result of the intermingling of people belonging to these diverse religious, over centuries, several distinct endogamous groups have been formed. In fact, studies conclude that Indian population now consists of 4693 communities with several thousands of endogamous groups, 325 functioning languages and 25 scripts. Another factor leading to the genetic diversity is the caste (socio-cultural) system followed by the Hindus, which sub-divides them into four distinct communities which initially evolved on the basis of occupations. Scientists have concluded that linguistic, geographical, socio-cultural distinctions have prevented free gene flow between the populations and led the formation of thousands of endogamous groups in India. The four major morphological types -Caucasoid, Mongoloid, Australoid and Negrito, are present in the Indian population. The Caucasoid and Mongoloid populations are mainly concentrated in the north and northeastern parts of the country. The Australoids are mostly confined to the central, western and southern India, while the Negritos are restricted only to the Andaman Islands The Austro-Asiatic speakers are exclusively tribals and are dispersed mostly in the central and eastern parts of the country. Molecular diversity studies have revealed that the Austro-Asiatic speakers are likely to have been the most ancient inhabitants of India. The current genome study has revealed that at the pan-India level, there were significant genetic variations between the tribal and caste populations. Further, in a geographical region too, tribes and caste people sub-classified on the basis of languages, exhibited genetic diversity. For instance, the isolated populations in the Himalayan belt in the North India, were genetically closer to the Chinese and Japanese populations than the people in the rest of the country. So far, the global genomic studies had classified Indian populations as part of the Asian group which mainly included the Chinese and Japanese people. The Indian study has demonstrated that two major populations segments-those speaking the Dravidian (DR) and Austro-Asiatic (AA) languages who are mainly the tribals -living in the central and southern regions were entirely different from the Asian populations used in the HapMap populations. Look for a person for my medicine ... The first dollar for human genome sequencing came in the 1990s. In fact, this June, it's the 10th year since the completion of the DNA sequence for the last of the 24 human chromosomes. More than two human genomes have been sequenced-Craig Venter and James Watson. A Chinese genome has also been sequenced recently and the Panda genome sequence will be completed by August. Besides, almost 1,000 human genomes will be sequenced in the next year. The pace of the sequence has accelerated but the question is, have we conquered the cures? One has been talking of personalized medicine, but Dr Brahmachari and his team are taking a different approach-they are talking about finding the right person person for my medicine. Recognizing India's unique strengths, CBT/IGIB launched two major initiatives in 1998. Scientists started analyzing genomes and correlating it with disease-based information available from hospitals. In the process, they also developed novel computing techniques--bioinformatics tools--that would help in the analysis of genomes. On that strength, Prof. Brahmachari and his team undertook the study of the Indian Genome Variation Consortium, a CSIR network project started independently in 2003 after it was decided that 45 samples cannot represent the total diversity of India to build the next generation map of human genome initiated by the International HapMap Consortium. "The objective was to create a basal data for disease profile and not to map genetic diversity. This is the first time anywhere in the world that a single country has been mapped to this extent," pointed out Dr Brahmachari. The Indian Genome Variation Consortium (IGVdb) database provides a genetic map of relatedness of 55 contrasting Indian populations for drug response and risk with respect to cardiovascular disorder, metabolic syndrome, diabetes, infectious disorders, high altitude disorders, asthma, and susceptibility to malaria and tuberculosis. While the information for the infectious disease will come free, that for all drugs in the market will come at a price. It is a monumental study on genetic profile of the country's population and the largest ever by Indian organizations. The Indian Genome Variation Consortium is a network of six institutes of the Council of Scientific and Industrial Research (CSIR), Centre for Genomic Applications, Indian Statistical Institute and anthropologists from various institutes, which undertook the study and generated information on over 4,000 genetic markers from over 1,000 biomedically important and pharmacogenetically relevant genes in 15,000 individuals encompassing the diversity of population across the country. Over 100 scientists are presently working on this project. Six CSIR institutes which are associated with the Indian Genome Variation Consortium are Institute of Genomics and Integrative Biology (IGIB),Dehi, Indian Institute of Chemical Biology (IICB), Kolkata, Centre for Cellular and Molecular Biology (CCMB), Hyderabad,Central Drug Research Institute (CDRI), Lucknow, Industrial Toxicology Research Centre (ITRC),Lucknow and the Institute of Microbial Technology (IMT), Chandigarh. This project is claimed to be a major success over the International HapMap Consortium project initiated in 2002 with a fund of $100 million. The global project, he said, covered only 45 Chinese, 45 Japanese, 90 Caucasians and 90 Africans. Fully realizing that 45 samples cannot represent the total diversity of India, the Indian Genome Variation Consortium was set up to conduct the study in the country. The results of the first phase of the study â€“ "Genetic Landscape of the People of India: A Canvas for Disease Gene Exploration" -- was published in the Journal of Genetics in April 20, 2008 as other reputed scientific journals were not having references to review the mammoth task done by the consortium. The Rs 25-crore study was taken up in 2003 and was funded by CSIR, the Department of Science & Technology (DST) and The Chatterjee Group, which set up a highly specialized laboratory for this purpose in IGIB. Genetic affinities The study found that genetically Indian populations could be classified into various clusters. The first cluster primarily comprised of tribal communities and Dravidians. The second cluster included Tibetan-Burmese populations irrespective of their geographical regions of habitat. This implies that these people living in different parts of India were genetically similarly. Some of the populations living in isolated Himalayan regions also belonged to this category genetically, though many of them were speakers of Indo-European language family. An interesting revelation is that the native populations of southern India, who spoke four or five distinct languages, formed a separate cluster together based on their genetic compostion. This essentially means that the social barriers erected by the caste system has no genetic base as it was believed to be. Most indigenous people in south India belonged to the same cluster. "The HapMap does not capture the entire diversity of the Indian subcontinent. Thus, it may be difficult to directly use the HapMap data to design genetic epidemiological studies for the entire population of India," the authors wrote in their Journal of Genetics paper. Another interesting revelation is that the populations in the southern parts of the country were genetically more prone to infections like the HIV than their counterparts in the north. The Aryan invasion theory Earlier studies had hypothesized that the Dravidian language speakers (Tamil, Telugu, Kannada and Malayalam), now geographically confined to the southern parts of the country, were spread across the country before the arrival of the Indo-European speakers. And the Dravidian speakers, considered to be the original inhabitants of India, were forced to retreat to only the southern parts after their interaction with the " invaders". Dr Brahmachari's study of genetic heterogeneity among the Dravidian speakers validates the above hypothesis. This hypothesis was also supported by the mitochondrial DNA analysis done by other researchers. The study indicates that the Indo-European speakers too exhibit genetic variations between various groups. However, and surprisingly, these two groups showed high levels of genetic differentiations between them despite centuries of inter-mingling. Essentially, the studies indicate that the north and south Indian populations, who have been culturally very different, were distinct genetically too. Such conclusions are likely to spark another round of intense debate within India as the distinctions are further accentuated by the vastly different economic profiles of the regions. Practical applications Citing that the study clearly elucidates the genetic profile of India, Sibal said, "The study finds the absence of a known genetic marker against HIV-1 in India, which has enormous implications in terms of finding what populations are susceptible to what diseases and help us not only predict the diseases as well as the effectiveness of drugs for these diseases." The study indicates a strong association between the genetic and linguistic profiles in India and also significant genetic differences in the association of disease associated genetic markers. The study has enormous practical implications. The data is expected to help in the construction of specific drug response maps to aid policy level decision making for drug dosage interventions and disease risk management for complex as well as infectious diseases. Scientists had tested the response of people to various drug molecules available in the Indian market. Preliminary results indicate that people in some parts of the country do not require some of the common vaccinations because they are genetically-equipped to respond to the infections. Public health agencies may be able use this data to make right and relevant purchases of essential vaccines and divert scarce resources to regions which need them the most. Pharma companies will also be able to tailor their distribution and marketing plans and ensure supply of appropriate medicines only to different regions. The details of the drug response mechanisms will be available to pharma companies. For instance the study reveals that Indians are susceptible to HIV and diabetes. Hence knowing which populations stand the risk of a particular disease, management of that disease would be easier. "A large number of projects have been undertaken in the data for predictive marker discovery and XIth plan aimed at utilizing this basal pharmacogenomics," Sibal said. He added, "The project will show the world how we go forward managing risk and discovering drugs." Narayanan Suresh in Bangalore and Shalini Gupta in Delhi   ]]> <![CDATA[Biotech losing steam?]]> https://biospectrumindia.com/news/95/1430/biotech-losing-steam.html https://biospectrumindia.com/news/95/1430/biotech-losing-steam.html Fri, 04 Apr 2008 11:50:00 +0530 New Page 1 Biotech losing steam? Things are not going too well for the biotechnology industry which is dependent on cutting edge innovation to develop new, more effective cures than the chemistry-based pharma sector, against several unconquered diseases. The product pipeline from the biotech industry seems to be shrinking if one considers the approval status biotech products by the US government regulatory, the Food and Drugs Administration (FDA). The US is the world's largest pharma market and hence the FDA approvals are watched with avid interest around the world. Particularly, the last two years, 2006 and 2007, have been very bad for the biotech industry with just 10 and 11 biopharma products approved by the FDA. According to a comprehensive study done by Dr Ronald A Rader, president of Maryland-based Biotechnology Information Institute, the situation will become alarming for the biotech industry if the FDA approval trend continues. From an average annual approval rate of 16.6 products, with a peak of 23 in 1997, it has been a downhill for the industry in recent years. Many analysts blame the FDA for its over-cautious approach as a result of recent spate of drug withdrawals from the market. Dr Rader, however, indicates that this may not be the case. Almost every product which did not get the FDA approval had some issues related to safety or efficacy. Majority of the products which got the FDA approval in 2007 were in the me-too categories. Few of them were original, innovative products. Three most hyped segments-recombinant proteins, monoclonal antibodies (mAbs) and indications against cancer-did not get any approvals from the FDA. In the last 10 years, these three segments were the most talked about parts of biotech and over 350 products were under development in these areas from the year 2000. Over half the products under development are treatments against cancer. Not one mAb or recombinant protein got approved in 2007 in the US. One promising drug, from Roche, Mircera, a pegylated recombinant erythropoietin (PEG-EPO) which got approved in 2007 may not reach the market soon due to issues related to patent infringement. A lot of drugs are obviously failing during the Phase III stage. This implies that the developers did not fully understand the strengths of the product or the regulators are asking too many questions for which the scientific community has no answers now. Nearly 25 products which had sought FDA approval in 2007 are still pending with the FDA. An equal number of products from biotech companies are likely to seek FDA approval in 2008. The approval trends of FDA will be watched closely this year and in 2009. Whether the biotech industry will continue to be a trendsetter or face economic decline will depend on the FDA approval trends in 2008 and 2009. Every one in the industry is keeping his/her finger crossed. While the established biotech companies are struggling to increase their product pipeline, a lot of action is taking place on the ground in Asia. Singapore is becoming a big hub for the life sciences industry. India is making every effort to ensure that the country becomes a major destination for contract research and manufacturing services (CRAMS). The national budget for 2008-09 has slashed excise duty on manufactured pharma products by half to 8 percent and decreased the federal value added tax by another 2 percent. The immediate beneficiaries will be the foreign companies who have manufacturing plants for pharma and biologicals in various parts of the country. Many biotech companies who have manufacturing units in Bangalore, Hyderabad, Pune and Mumbai will also benefits. Most Indian pharma companies have shifted their manufacturing plans to tax-free states of Himachal, Uttaranchal and Jammu and Kashmir in recent years. Such units can eventually hope to attract more orders outsourced from pharma companies due to the competitive rates. Industry leaders will be gathering in Bangalore for the 8th edition of the Bangalore Bio event and hopefully will get some time to discuss the future growth strategy for the domestic industry. <sureshn@cybermedia.co.in>   ]]> <![CDATA["Lab India enjoys a formidable share in the mass spectrometry business,"]]> https://biospectrumindia.com/news/95/6504/lab-india-enjoys-a-formidable-share-in-the-mass-spectrometry-business.html https://biospectrumindia.com/news/95/6504/lab-india-enjoys-a-formidable-share-in-the-mass-spectrometry-business.html Fri, 04 Apr 2008 11:46:00 +0530 New Page 1 "Lab India enjoys a formidable share in the mass spectrometry business," -Umesh Pawa, VP, PSM division, Labindia Instruments Pvt Ltd Gurgaon-based Lab India's PSM division has completed a decade of operations and has been a consistent performer ever since it sold its first mass spectrometer to Ranbaxy. Umesh Pawa, VP, PSM division, Labindia Instruments Pvt Ltd, speaks to BioSpectrum about the company's new products and trends in the mass spectrometry. How has the mass spectrometry (MS) market grown over the years? We started in 1996 and till 1998 there were no sales. The technology was not very well accepted in India and we were proving the technology to our very first buyer, Ranbaxy. After they saw the value they got another system, which was followed by few more buyers and at the same time, the CRO business started in India. We started seeing a steady growth of 25-30 percent from 2000. In 2004, the market saw a sudden growth of 100 percent in the mass spectrometry segment and we are the clear leader. Since then, the growth has been very uniform. The MS market is now growing at a steady rate of 20-25 percent. How is the PSM division performing? The MS market was estimated at $40 million between July 2006 and June 2007 and Lab India enjoys a formidable share. Our MS business stood at $29 million during that period. This includes sales and service. The reason for this dominance in the market is a good after sales service and support for these high tech instruments. Being high cost instruments our customers can't afford downtime on these instruments. We have put together a support infrastructure in terms of service, application support, and initiatives for providing spare parts. What have been some of the recent developments in the division? Some of the developments have been in the area of therapeutic drug monitoring wherein one needs to monitor the concentration of the immunosuppresants that are given to a patient to avoid the body's resistance during an organ transplant. Traditional techniques like immunoassays give a very high false negative and positive rate and the variability in results is very high. Of late mass spectrometry has been found to be very precise and accurate in measuring the results. In India, hospitals haven't yet employed this technology. This technology is widely used in the US and Europe. In forensics, mass spectrometry is used to precisely measure the concentration of banned drugs of abuse taken by athletes in their sweat, blood, and urine. We have launched a new system, developed by Applied Biosystems, called Cliquid, for forensics recently. In one shot, a 20 minute run, it can check for 1200 drugs of abuse, screen for all these compounds and tell if they are present. This is not yet in practice in any of the labs, but we are in discussion with some of them. What are some of the new products that you introduced? Cliquid is a software platform rather a series of software that gives a black box kind of a result, even a non expert user in mass spectrometry can easily operate it because it gives readymade methods. The latest launch is Cliquid for forensics. Before this we launched two more variants, one was Cliquid for food analysis that gives ready made method for testing adulterants (Sudan dye in red chili), pesticides and antibiotics residues. Cliquid for quant software was the earliest version (skeleton version) that helped to run methods for a particular molecule. Several companies today focus on drug discovery (NCEs) wherein several compounds are synthesized everyday and screened to see if they suit the pharmacokinetic profile that is intended. MS is being used for these analyses but in order to automate this process we launched the Discovery quant station for early ADME studies. The software automatically optimizes the conditions for each one of the several compounds and runs a PK profile on a short subset of each of these samples. This process is different from the bioequivalence, bioavailability studies in case of clinical trials because there we have a large number of samples and few molecules. So the focus here was to do a quick screening method and run the samples quickly. Shalini Gupta   ]]> <![CDATA["Thermo Fisher Scientific continues to invest substantially in R&D spending globally,"]]> https://biospectrumindia.com/news/95/4079/thermo-fisher-scientific-continues-to-invest-substantially-in-rd-spending-globally.html https://biospectrumindia.com/news/95/4079/thermo-fisher-scientific-continues-to-invest-substantially-in-rd-spending-globally.html Fri, 04 Apr 2008 11:30:00 +0530 New Page 1 "Thermo Fisher Scientific continues to invest substantially in R&D spending globally," -Amit Chopra, MD, Laboratory Products for Thermo Fisher. Thermo Fisher Scientific clocked a record year in 2007, with 10 percent growth in sales over 2006 to nearly $10 billion. The Laboratory Products business of Thermo Fisher Scientific provides a combination of products and services that allow scientists to engage in functions of research, development, manufacturing, clinical diagnosis and drug discovery more accurately, rapidly and cost effectively. Amit Chopra, managing director, Laboratory Products for Thermo Fisher reveals about the company's contribution to biotech R&D. What is Thermo Fisher's contribution to the Indian R&D segment over the last one year? Thermo Fisher Scientific is a partner to scientists and laboratories advancing "personalized medicine" and pioneering "protein-based" drugs through biomarker discovery. We're focused on providing innovative essential lab equipment, analytical instruments, supplies and bio-tools for researchers working in the fields of immunology, cell biology, molecular biology, drug discovery, genomics, proteomics, systems biology and stem cell biology. We are a major supplier to vaccine manufacturing industry with our NUNC branded cell factories and roller bottles. We also have advanced solutions for high throughput screening and robotics for drug discovery. We are setting up a new $17 million facility in Ahmedabad to support the growing demand for biopharma services. This facility will focus on packaging, global distribution and logistics management of tightly regulated pharmaceutical samples to patients participating in clinical trials across the globe. How does Thermo Fisher bring about innovation in all its products? Thermo Fisher Scientific continues to invest substantially in R&D spending globally, to bring new products to market. These products include instruments, reagents and consumables used in areas such as pharmaceutical research, clinical diagnostics, environmental and food safety applications throughout the world. What are the new products that will be launched in the near future? We have launched a complete range of plastic disposable products that include the patented ART tips, Micro centrifuge tubes, PCR consumables and Arrayscan VTi, an HCS (High Content Screening) system sold under the Thermo Scientific brand. In addition to this, we are also launching new high-end equipment, advanced centrifuges, biological safety cabinets, Microplate Instruments, Lab Automation and several innovative cold storage products and advanced laboratory water purification systems. What is the current market scenario for the Biosupplier segment? The Indian Biotechnology industry is annually growing at the rate of 30 percent and is likely to grow $5 billion by the end of 2010. India will emerge as a key destination for clinical trials, contract research and stem cell research. Thermo Fisher Scientific is solution provider for all these applications. For example, we provide Thermo Scientific incubators, centrifuges, biosafety cabinets, magnetic particle separators, microplate readers, liquid handling, and plastic consumables as part of total workflow solutions for these applications. We also offer a wide range of products for specific segments in biotech, e.g. our initiative for "Stem Cell Excellence". How do you think Biosuppliers have augmented the progress of the Biotech industry? Explain in context of Thermo Fisher Scientifics' role? We introduce new technologies and solutions to meet the challenges faced by researchers in their day to day work. This not only eases the research process but also reduces the time taken to convert an idea into a product or a solution. At Thermo Fisher Scientific, we have been successfully serving the needs of the healthcare industry for generating life saving drugs and vaccines. We provide systems for culturing and nursing cells used in production of drugs and other bio active compounds as well as virus cell populations and vaccines. Also, through our NUNC brand we have provided large scale cell culture system to various leading bio production vaccine manufacturing companies in India. The services of Thermo Fisher Scientifics range from pre-procurement to after-sales-support, meeting the various accreditation standards and norms. Nayantara Som   ]]> <![CDATA[IR, UV-VIS instruments in India]]> https://biospectrumindia.com/news/95/7779/ir-uv-vis-instruments-in-india.html https://biospectrumindia.com/news/95/7779/ir-uv-vis-instruments-in-india.html Fri, 04 Apr 2008 11:13:00 +0530 New Page 1 IR, UV-VIS instruments in India The combined UV/VIS market in India is $16 million. The history of modern instrumentation for optical spectrometry especially for Infra-Red (IR ) and UV-VIS can be traced back to the 1940s. This started with the development of instrumentation for the testing of materials, such as petroleum products and polymers, to be used in the manufacture of military goods and equipment for use in World War II. Commercial Infra-Red Instrumentation Early instrument manufacturers included Beckman (USA), Perkin-Elmer (USA, UK and Germany), Pye-Unicam, Hilger, Grubb-Parsons (UK), Zeiss (Germany), in the Western markets and JASCO (Nippon Kogaku Company), Hitachi and Shimadzu in Japan. Essentially all of these instruments were based on dispersive monochromator designs, with most in a double beam configuration. It would be generally inappropriate to single out individual manufacturers or models--there were many different instrument designed and marketed during this 20 year period. However, it is historically important to mention the original Perkin-Elmer model 12 and the Beckman models IR-1 and IR-2. Design concepts from these instruments existed for at least 20 to 25 years in various derivative products. Anil Nimkar is working in Perkin Elmer (India) Pvt Ltd and is a Line Leader in Molecular Spectroscopy (FTIR/NIR, PUF) for developing business in West Asia. He is working for Perkin Elmer products for last 20 years and he was involved in marketing and handling of other analytical techniques like Chromatography, Real-time Measurement and also Life Science Products.   The first commercially available Spectrometer Model 12 IR was manufactured by PerkinElmer. First commercial FTIR was Model FTS-14 Spectrometer. The First affordable high performance FTIR Model 5 MX was made available to a wider community of researchers. The most significant development in 1970s was the introduction of FTS-14 by Block Engineering, a fully functional, mid-infrared FTIR instrument. This spectrometer, which became the start of a line of products under the Digilab company, providing a fast Fourier Transform calculation, as well the main ones being Nicolet, Perkin-Elmer, Digilab, Mattson Instruments, Bruker (in USA certain Bruker instruments were originally marketed by IBM), Analect, Bomem and JEOL. From the mid-1980s, the period is best described as a time of enabling technologies, specialized application and dedicated instrumentation. One of the benefits gained by the move to FTIR instrument technology was the overall improvement in optical throughput, in part achieved by superior detector technology. As a result, over the past 15 years there has been a rapid expansion in the availability of novel sampling accessories that provide opportunities to handle almost any type of sample, and to be able to acquire a useful spectrum within 1 or 2 minutes. With a high sensitivity detector, it is no longer a problem if the energy losses due to the sampling accessory limit the light throughput to a few percent. The major FTIR companies--Bio-Rad-Digilab, Nicolet (including Spectra-Tech), PerkinElmer;Jasco Bruker, Bomem and Shimadzu--offer systems and packages for these new applications from high-end to low-end. An evolution has taken place in terms of the format of infrared instrumentation and in most cases, this has been market/application driven. With the exception of the high-end research instruments, these can be characterized as: The multi-faceted analytical system Compact, flexible routine systems Customized analyzers Modern NIR instrumentation falls almost exclusively into the category of customized instrumentation. However, the form of the instrumentation can be very different, depends on the applic ation. The most traditional instruments can be classified in two ways; laboratory-based instruments for method development and plant-based instruments, including environmentally hardened instruments for on-line measurements. These tend to feature common technology for both forms of instrument â€“ simplifying the task of data and calibration transfer. FT-NIR instruments (optimized for near-infrared measurements) have gained popularity and these systems are now offered by many of the traditional vendors, including Bomem, Analect, Nicolet, Bruker and Perkin Elmer. IR market growth in India is around 12 â€“ 15% per annum. Number of Vendors by Price Point Many of the newer NIR systems are custom designed for specific areas of application. The two most significant directions have been for small field portable instruments and on-line analyzers. The small field portable systems, features a range of technologies, including lED or diode laser sources, fixed optical filters (including integrated filter/detector combinations), or photodiode arrays. They are typically used for pilot plant studies (chemicals and fine chemicals) and raw materials QC/QA, as well as food, pharmaceutical and petroleum product manufacturing applications. Recent interest has focused on biomedical and clinical applications, with special attention to the measurement of blood glucose level for diabetics. FTIR market and the products available in India FTIR and NIR markets are very diverse in terms of its utilization hence they are sold in the specific applications that the instrumentation performs. These can be classified as routine or non-routine instruments. Routine: The instruments are used for day-to-day performance with a fixed task, identification, quantification, in process or final materials, in academics teaching etc. Non-routine: The instruments which are used for trouble shooting and research and development purpose, spectroscopic evaluations, product development where the utility of FTIR or NIR will vary as per the purpose. The FT-NIR analyzers market has several vendors and specific technologies. The market in India has been growing for last few years and around 250 units ($9 million) of IR and NIR products have been sold. Infra-red market is growing in India. FTIR is well established and Near-IR is getting accepted in the Process Analytical Technology (PAT). However, Indian market is price sensitive. There are plenty of opportunities in routine as well as non-routine market with the involvement of hyphenated techniques such as IR-Microscopy Imaging, TG-IR, Optical measurements and Chemometrics. Commercial UV-VIS Insutrumentation The earlier UV/VIS instrument manufacturers included Beckman, PerkinElmer, Pie-Unicam, Varian, Hitachi, Shimadzu, Jasco, Bausch & Lomb etc. Initially the instrumentation was filter based, then single beam spectrometer which is followed by double beam spectrometers which got well established in the Vibrational Spectroscopy. The Beckman Model DU Spectrometer was the first commercial UV/VIS Spectrometer marketed in 1941. Then there were series of instruments from Beckman, PE, Varian establishing their various brands like; Beckman DU series, PerkinElmer Lambda series & Varian Cary series. These were also competed by the various instruments from Hitachi, Shimadzu as well as Jasco. The UV/VIS spectrometers currently offered by number of vendors can be segregated with a price point. Double beam UV/VIS Spectrometer includes the most advanced instruments in the UV/VIS market today. They allow more rapid and simplified UV/VIS analysis for the users. In the medium range spectrometers, there are more than 22 vendors. However the vendors active in the Indian market include: PerkinElmer, Shimadzu, Varian, Thermo, Hitachi, Jasco, GBC etc. Various instrumentation such as single beam, split-beam, dual beam and double beam spectrometers are available in the market. However, double beam UV/VIS spectrometer includes the most advanced instruments. They allow more speedy and simplified UV/VIS analysis for the users. The double beam UV/VIS instrument is dominated by the major diversified analytical manufacturers such as Perkin-Elmer, Shimadzu, Varian, Hitachi, Thermo, Jasco and others. The basic double beam instruments remain same, however the high performance instrumentation got established especially from UV/VIS and UV/VIS-NIR for the diverse group of industrial end market including material, glass & non-optical, coating & paints, pharmaceuticals, life science, semi-conductors and textiles. These industries which were initially established in the North America & Europe and growing fast in the emerging markets such as PACRIM including China & India. The high-end products are mainly manufactured by PE, Varian, Hitachi etc. The various measurements were carried out by this technology and many reflectance accessories were used such as Integrating Spheres, Relative and Absolute Specular Reflectance accessories. These accessories were developed for many applications and customized which were followed in the commercial market. The combined UV/VIS-NIR market in India is around $16 million which is growing at 10â€“12 percent annually. This is mainly because of the growth and the industrial development in various sectors such as material, glass & non-optical, coating & paints, pharmaceuticals, life science, semi-conductors and textiles. The IR & UV-VIS Instrumentation is establishing in the growing Indian market in various areas for day-to-day utilization as well as for the demanding applications of material characterization. The meaningful accessories like integrating spheres, various reflectance accessories and microscopy imaging techniques are having opportunities to increase the quality of life. Reference : Analytical Instrumentation Handbook by Galen Wood Ewing.   ]]> <![CDATA["Fluorescents are replacing traditional dyes in protein detection assays,"]]> https://biospectrumindia.com/news/95/7263/fluorescents-are-replacing-traditional-dyes-in-protein-detection-assays.html https://biospectrumindia.com/news/95/7263/fluorescents-are-replacing-traditional-dyes-in-protein-detection-assays.html Fri, 04 Apr 2008 11:12:00 +0530 New Page 1 "Fluorescents are replacing traditional dyes in protein detection assays," -Dr Duncan Veal, CEO, Flourotechnics Sydney-based biotechnology company, Fluorotechnics develops and manufactures fluorescent compounds and fluorescence-based kits for the global biotechnology industry. Fluorotechnics aims to build a portfolio of intellectual property in the area of fluorometrics that will be licensed to diverse sections of the biotechnology industry. The company owns the intellectual property to a new family of structurally related fluorescent molecules-the epicocconone family of fluorophores. These molecules have low molecular weight and long stokes' shifts. Fluorotechnics also owns IP governing the application of these and other fluorophores for various assays. In an interview with BioSpectrum Dr Duncan Veal, CEO Flourotechnics, shares the company's products and strategies. Some excerpts: Can you elaborate on the bio-fluorescent industry as such and where is Fluorotechnics positioned in the industry? Fluorescence is becoming increasingly important as a method of detection and quantification and is replacing traditional technologies based on colored dyes and radioactive isotopes in the life sciences, in areas ranging from research through to process and quality control. The market for fluorescent labels used for life-science research alone has grown rapidly over the past 10 years to about half-a-billion dollars. Many if not most of the latest diagnostic techniques are also based on fluorescence and the market for in vitro fluorescent diagnostics has grown in excess of $2 billion. I think we can expect to see: the market for fluorescent diagnostics continue to grow as fluorescence-based research tools transition into diagnostics and as the installed-base of fluorescence-based instrumentation increases. At this point in time, Fluorotechnics mainly supplies to the life science research tools market but increasingly our customers are applying our technology and products in areas such as diagnostics and quality control. I envisage that products in our current pipeline will expand our footprint outside of our current focus market of research tools. How far has Fluorotechnics come since it came into existence in 2001? Fluorotechnics, a spin-off from Macquarie University in Sydney, was founded in order to commercialize a new family of non-toxic fluorescent molecules derived from a filamentous fungus. The University had patented chemical structures of the fluorophores and this patent was transferred to the company. Fluorotechnics rapidly developed a number of products, based on the IP. These are used for fluorescently staining proteins and peptides in electrophoresis gels and on blots. In addition, we developed fluorescence-based products for protein and peptide quantification and for live cell imaging. We are the only company worldwide that produces fluorophores from filamentous fungi. Australia is a small market and as a start-up company our approach was to appoint global distributors such as Amersham Biosciences (subsequently acquired by GE-Healthcare), Sigma-Aldrich and Active Motif as sales and distribution channels to our market. In North America and Europe we are currently establishing our own sales and marketing team to focus on our products and increasingly we are selling products directly via our website (www.fluorotechnics.com). We have developed a new technology for measuring enzyme activity and the first product for measuring protease activity-LavaDigest-was launched last year. Recently, we also launched a very rapid and simple to use fluorescent protein gel stain â€“ LavaBlue â€“ that is suitable for use on widely available gel documentation systems. LavaBlue enables labs that do not have access to expansive gel imaging systems to move into the world of fluorescence. Fluorescence is becoming an increasingly popular detection and quantification technique in the area of proteomics and most of our fluorescence-based kits are used by scientists involved in this field, especially in the area of gel electrophoresis. Last year, we acquired a German electrophoresis company, Elektrophorese-Technik (ETC) (www.etcelpho.com) that specializes in the development and manufacture of high-end electrophoresis consumables for research, quality control and diagnostics applications. What is Fluorotechnics USP vis-a-vis your competitors? We offer a unique technology, based on a fluorophore called epicocconone, that enables the ultra-sensitive detection and quantification of proteins against a zero fluorescent background and yet still leave the proteins unmodified for down-stream processing. This is particularly important in proteomics where it is essential not to modify proteins to enable subsequent identification using techniques such as mass spectrometry. Epicocconone has the unique property of becoming fluorescent on reversible conjugation to proteins and peptides. Although it is a relatively simple molecule it remained unknown to scientists, as it is very difficult to chemically synthesize. The most convenient source is from our filamentous fungus. Epicocconone is a non-toxic, readily biodegradable molecule in contrast to many competitor fluorophores in the proteomics market that are toxic and/or based on heavy metals. In your current product portfolio, what would you classify as "star products"? Undoubtedly our protein stain LavaPurple is a star product. It is the best protein stain in terms of sensitivity, quantification, and mass spec compatibility. It is versatile and can be used for both gel and blot staining and unlike most competitors is non-toxic making it safe to use and environmentally friendly. We have formulated LavaPurple into a kit that contains all the buffers and fixatives required for staining making it a very simple and convenient product to use. Are you looking at expanding your product portfolio? Yes, of course. The major markets for our protein electrophoresis product portfolio is dominated by a few big players and in reality there have not been a lot of new products in this area in recent times. We see significant opportunities to be identified as the innovative company in protein electrophoresis and to bring new products and technologies to this market. We are particularly interested in those products that facilitate the transition from traditional visualization techniques such as Coomassie and Silver staining to fluorescence. What is Fluorotechnics outlook for the next five years? Fluorotechnics is focused on bringing to market a number of new products and applications and continuing to improve and expand its sales and distribution channels. Thus the company will grow organically at a fast rate. We are seeing substantial benefits from the last year's acquisition of German Company, Elektrophorese-Technik (ETC) who make complementary products, and have identified that there is a major opportunity to 'roll-up' a number of companies in the research-tools field and we will be concentrating on this. Do you have an Asia Pacific strategy? What kind of growth do you expect from these markets? What are the countries you are looking at? Asia Pacific is a very large and diverse market and one single strategy to cover this market is probably not appropriate. However, many countries in the region have had a tradition of being very strong in life sciences at a tertiary level and this is now being translated into a dynamic biotechnology sector and these markets are certainly experiencing double-digit growth. We have recently appointed distributors to cover Korea, China, Singapore, Thailand and Malaysia and will be focusing the appointment of distributors to cover Taiwan and India over the next month or so. Ajeesh Anand   ]]> <![CDATA["We've plans to open Thailand and Malaysia chapters"]]> https://biospectrumindia.com/news/95/2389/weve-plans-to-open-thailand-and-malaysia-chapters.html https://biospectrumindia.com/news/95/2389/weve-plans-to-open-thailand-and-malaysia-chapters.html Fri, 04 Apr 2008 11:07:00 +0530 New Page 1 "We've plans to open Thailand and Malaysia chapters" -Thomas Adams, President & CEO, Association of Clinical Research Professionals (ACRP) Thomas Adams was named CEO of the Association of Clinical Research Professionals (ACRP) in 2002. In 2005, he was given additional title of the President of ACRP. Active in a number of associations Adams has served as an officer and director of the American Association of Medical Society Executives and has held a number of appointed positions including US Department of Health and Human Services Secretary's Advisory Committee on Human Research Protections, the Hawaii Convention and Visitors Bureau Advisory Committee, Chairman of the Governor's (WI) Advisory Committee on Health Insurance for Uninsured (SACHRP). During the launch of ACRP Singapore Chapter, in an interview with BioSpectrum, he shares the objectives and benefits of the Association. Some excerpts: Why is ACRP keen on opening a chapter in South East Asia in general and Singapore in particular? According to market analysts, by 2008, up to 30 percent of global clinical trials will take place outside of US and Europe. India and South East Asia are the favored places for those trials to take place. Even the pharma companies have increasingly been outsourcing their clinical trials to other parts of the world and no other region gets as much of it as Asia. Even in a recent report by PricewaterhouseCoopers that surveyed pharma executives in nine Asian countries 58 percent of the respondents expect Asia to lead the global pharmaceutical market shift. At the same time professionals joining ACRP, from countries other than US represent the fastest growing segment of our membership, and has already crossed over 3,000. Keeping in view the demand, we began to look for a partner to open chapter for Asia Pacific region back in 2004. Singapore has been emerging as a hub for early stage clinical trials. The implications for employment in the region are significant especially as the country has established itself as a center for clinical trial oversight in Asia. The job market looks promising in this space. Through the development of a chapter we wish to participate in Singapore achieving its share of this goal. At the same time, in near future, we have plans to open chapters in Thailand and Malaysia as well. What is ACRP? The Association of Clinical Research Professionals (ACRP), a voluntary organization, is a primary resource for clinical research professionals in the pharmaceutical, biotechnology and medical device industries, as those in hospital, academic medical centers and physician office settings. ACRP was founded in 1976 to address the educational and networking needs of research nurses and others who supported the work of clinical investigations. Now, it is a global association of 21,000 individuals who are engaged in the performance of clinical trials on human beings. The ACRP is responsible for interaction and management of over 50 of its global chapters and forums to provide assistance and service to the chairs and their members and assist with the development of new chapters and forums. It organizes and host chapter officers' workshop and forum educational and networking programs at the annual global conference and exhibition. It is responsible for managing all ACRP business relationships with current and potential global business partners and collaborators. It recently started its Singapore chapter in association with Bilcare Research. What kind of activities ACRP undertakes for the benefit of its members? The association conducts examination for certification for the clinical researchers. Besides certification, the association monitors the evolving field of clinical research, identifies knowledge requirements of the clinical professionals worldwide and develops educational programs to support the field. The programs include opportunities for learning in the classroom through seminars, workshop, conferences, and good clinical practices (GCP) courses, learning through online clinical and leadership courses, participating in webinars with expert instructors and so on. What are the benefits of doing ACRP certification program? A certification is the formal recognition of clinical research professionals who have met professional eligibility requirements and demonstrated a baseline level of job-related knowledge and skills. We believe certification can benefit the public through ensuring the development and preservation of the highest quality and standards in clinical research. The other intangible benefits of taking up the certification by a professional is that there will be fewer errors, lower costs, rapid turnaround and greater safety while conducting the trials. Even the feedback from the pharmaceutical companies has been the same on the certification. We believe it is through ACRP certification that global standards of knowledge of clinical trials can be demonstrated. As of now how many professionals hold ACRP certification? Since 1992, ACRP has been a leading certifier of clinical research professionals. More than 18,000 professionals hold a designation such as: ACRP certified clinical research coordinator, clinical research associate, physician investigator, or non-physician investigator. To help the candidates prepare for the FDA, ICH and European certification exam, ACRP offers classroom-based Certification Exam Review courses, as well as online practice exams and prep packages.   ]]> <![CDATA[Satyam steps up focus on life sciences]]> https://biospectrumindia.com/news/95/2310/satyam-steps-up-focus-on-life-sciences.html https://biospectrumindia.com/news/95/2310/satyam-steps-up-focus-on-life-sciences.html Fri, 04 Apr 2008 10:56:00 +0530 New Page 1 Satyam steps up focus on life sciences Satyam's recent foray into the life sciences segment can prove to be a significant differentiator for it in the market. Global business giant and information technology services company, Satyam, announced in the latter half of February, the setting up of its life sciences Center of Excellence (CoE). The facility in Hyderabad was inaugurated by Satyam's founder and chairman, B Ramalinga Raju on the sidelines of RxCellence, the Life Science's conclave. Satyam is not the first IT company, which has pushed its envelope into the life sciences segment. IT bigwigs like Wipro, HCL, and TCS have already created a strong foothold in the life sciences, a good enough testimony of the growing importance of this sector. Satyam's life sciences CoE will house solutions cutting across the value chain, addressing a number of industry pain points. "Customers have moved away from the traditional services model. They are now looking at us, the service providers, to help identify tomorrow's business challenges and collaborate proactively in building solutions and frameworks which deliver faster and better Return on Investments (ROI)," said Ram Mynampati, president, commercial and healthcare business, Satyam Computer Services Ltd. The life sciences CoE will addresses industry needs in the areas of clinical drug accountability, drug counterfeiting, cell line management systems, high throughput analytics, clinical development, bioinformatics, supply chain, CRM, key opinion leader portals. Strategy behind CoEs Setting up CoEs has been a key business strategy model for Satyam. A de-risking strategy. In the past, the US market constituted around 85 percent of their business today it has come down to 60 percent. "We looked at various dimensions and identify various strategies for de risking. The fact that we are operating in nine different markets today is a testimony to the success," said Mynampati. Satyam had set up a number of CoEs before in different market segments like retail, customer products, health insurance and financial services. The primary strategy was to align themselves with the particular market, demonstrate the convergence of the technological expertise with the business developments of the market into something more tangible. Moreover Satyam wanted to shift from a volume-based industry to a value based business, from a general IT services and solutions provider to an industry oriented business based solutions. "Customers want to know as to how much understanding we have of the businesses of their industry, what are the investments we have made and not just the monetary part but also the investments we have made in terms of effort and competencies and convert that understanding into tangible solutions and leverage it where ever they want," added Kishore Rachapudi, global head, life sciences, Satyam Computer Services Ltd. "We needed to identify those few things which we could focus on, which would be a differentiator for us. For us the purpose of setting up a CoE was how do we integrate these different market segments so that we would be operating at an aggregated level to create a solution which cuts across all CoEs and to create a holistic service solution in the healthcare market," added Mynampati. Venturing into life sciences can prove to be a major differentiator for Satyam. The company sees a world of opportunity in the major hiccups of the industry, which includes a number of drugs going off patent which in the past churned out huge amount of revenues for major pharma companies. Plus, there is a dire need for innovation in such a scenario. "The industry is now looking for partners like us who will help them not just to improve the pipeline but also bring in drugs faster into the market while doing this there should not be any risk as such to the patients," added Rachapudi Foray into the life sciences Industry Life sciences is a domain which is not really new for Satyam. In fact, there are four organizations dedicated primarily for the healthcare industry which also includes the emergency medical service (the 108 service in Andhra Pradesh) and Health Management Research Institute. Satyam had gained expertise in consulting and providing IT solutions to the life sciences industry with a clientele base spanning across US, Europe and Asia Pacific. "We had been providing IT services to global pharma, biotech and medical devices companies and now have a dedicated focus to cater to our life sciences customers' needs," comments Rachapudi. This was the base foundation for Satyam. The CoE is but a superstructure from where Satyam will intend to consolidate its position in life sciences like it has done in other healthcare verticals. Three-four years ago Satyam's customers were typically in the manufacturing space, but in the last two years Satyam has been pouring in a lot of investments in the research sector "We have embarked on the initiative of creating CoEs because life sciences has been the biggest and fastest growing market for us. It accounts for 6 percent of our revenues," added Rachapudi Speaking at the life sciences conclave, Satyam's founder, Ramalinga Raju, emphasized on Satyam's keen interest in strategizing ways and means to change the healthcare industry and hence its gradual foray into the life sciences industry. "The life sciences industry and the IT sector have a lot of commonalities. The most important being that the life sciences industry, like the IT industry, in a way deals with information sciences. That is when the two segments can be integrated together," he added. Priority focus Satyam's Life sciences CoE will maximize ROI by focusing on the following two areas: Business pain points are the areas where visible or invisible investment leakages happen. The solution concepts are positioned to arrest such leakages thus ensuring faster ROI. Usually the IT solutions are costly and time consuming. This implies a lot of investments are unrealized till the implementations start fully functioning. Satyam's reusable CoE components and domain expertise reduce time to fetch benefits from such solution implementations, thus ensuring faster ROI. Services provided The objective of the life sciences CoE is to create an umbrella to include Proof of Concepts (PoC) for different areas in the pharma value chain. Under the CoE, the PoCs includes within its purview important components namely R&D, manufacturing, supply chain management and sales and marketing. "The CoE is being lead by four leaders, who have worked in life sciences industry with cumulative experience of over 50 years across R&D, manufacturing, supply chain management and sales and marketing. The collaborative strengths that can be drawn for development of solutions is huge. The team is growing year-on-year as per the growing needs," added Rachapudi. Satyam today deals with around 26 customers in the life sciences space with a man force of around 1300 plus personnel. Said Mynampati, "We are working with six of the top 10 pharma companies, besides some of the biotech majors. We are also looking at other customers from the value chain." As far as workforce is concerned, the CoE at present is focusing on three different kinds of competencies, one is technology competency which is the life blood of Satyam; the domain competency, where people from the industry are involved like physicians, the academia who are involved in research activities; and the third category will include experts who study the needs of the market and the process needed. "These three kinds of expertise come together and will create what we call as a competency driven CoE," added Mynampati. Non-linear growth Though tight-lipped about the investments made and the target revenues in the coming years for this initiative, Satyam officials indicate that they will be following a non-liner growth model (where the income generated is non-linearly proportional to the people employed) as they had enforced in other segment. "The market today is going from a linear to non-linear growth model. And our investments have been on the non linear path," informed Mynampati. This Satyam believes will be a more sustainable model and the opportunity will be much greater in the assets that are created rather than the head counts. In such a situation thus, to grow 10 percent it does not matter that you have to grow 10 percent in head count. "The only way is to create retainable assets, continue to look at creating efficiencies in resources so that the revenue per employee goes up and maximize the return on investments. Non linear investments are a direct consequence of the investments we make in enhancing the quality of the business not quantity," added Mynampati. Integration of IT with life sciences Both the sectors have been conceived as being extreme sides of the pole; however the initiation of this life-sciences CoE refutes this point. "The Indian IT industry has the capabilities and experience to understand the pain areas of the life sciences customers and provides effective and efficient IT solutions to not only speed up the processes but also to streamline and integrate the processes. IT companies like Satyam have developed frameworks and best practices to allow better functioning of areas in the life sciences value chain like R&D, manufacturing, sales and marketing and corporate governance. Outsourcing the IT support and development to IT companies like Satyam will allow life sciences customers to focus on their core activities of drug discovery, research, manufacturing and selling and improve bottom lines through cost arbitrage and leveraging economies of scale," added Rachapudi. Satyam now venturing into the aerospace and defense areas is a good enough proof that IT solutions alone can bring about smarter solutions for innovation. The same can be applicable to the life sciences division. Nayantara Som in Hyderabad   ]]> <![CDATA["We are trying to emerge as an Indian MNC CRO"]]> https://biospectrumindia.com/news/95/2596/we-are-trying-to-emerge-as-an-indian-mnc-cro.html https://biospectrumindia.com/news/95/2596/we-are-trying-to-emerge-as-an-indian-mnc-cro.html Fri, 04 Apr 2008 10:41:00 +0530 New Page 2 "We are trying to emerge as an Indian MNC CRO" -Dr Chetan Tamhankar, COO, Siro Clinpharm Pvt Ltd Siro Clinpharm had recently announced its implementation of the Oracle Life Sciences Applications to improve operational efficiencies in clinical development. This IT framework will be a catalyst in commencing Siro's globalization plans. While DBMS Consulting will implement Sun Microsystems infrastructure, Oracle Life Sciences Applications will optimize Siro's clinical trials and clinical data management operations. Dr Chetan Tamhankar, chief operating officer of Siro Clinpharm Pvt Ltd shares more insights. Can you elaborate on the IT framework which Siro Clinpharm has initiated in association with Oracle Life sciences and Sun Microsystems? It is Oracle Life Sciences, which covers the system for managing the clinical trials globally, a system for doing data management, electronic data capturing and internal business systems. We hope to build efficiency in our work here in India. As our thrust now is on globalization, it will become critical that our monitors stationed in Europe and Asia access the system and get the reports on time. Oracle is in a good position to help us achieve continued growth and support. When did Siro realize that such a framework had to be implemented? We have been in this business for the last 12 years and know how to deliver in India. But the question was what's next? We needed to look beyond the normal route to maintain our growth rates. We needed to address some limitations on the supply side be it manpower or trained doctors in India. This framework was also needed with our plans to go to non-traditional geographies like Central and Eastern Europe, other parts of Asia like Philippines Singapore, China, Korea, Thailand and Malaysia. We are trying to emerge as an Indian MNC CRO. To have this global desirability we need to have seamless operations between different geographies. That's when we believed that what we were doing till now was only good for our operations in India. The new IT framework can help us achieve our global plans. How will this help in Siro's globalization plans? It will increase our efficiency in R&D and allow for seamless operations across the globe. This will fall now within the purview of Sun Microsystems. So tomorrow if we set up a data management base in Europe, interaction between experts sitting in different databases across the globe, say Europe and India, will be smooth sailing. So the IT system will help people to be connected everywhere and it will greatly help us in making work efficient and faster. What are some of your growth strategies? The goal is to come up with delivery strategies in this region, look for customers and tap markets, and create business development and sales availability in geographies like North America, Western Europe, and Japan. If we need 500 patients to be taken in, we will get a manager from Germany, recruit in Romania, Hungary, Philippines and India and thus get the 500 patients. All these years we have been talking about a smaller pie of the larger global clinical trials but now we want to position ourselves for a bigger share through our European and Asian capabilities and this IT framework will help us achieve this goal and we will also be able to cater to global demands. Are you considering any M&As? While global CROs are coming to India, Indian companies wish to become global players through presence in other countries, building their credibility and capabilities. That will definitely happen in the near future and Siro at the moment is targeting countries within Europe from that perspective. Acquisitions within the domestic market will cost us much more. We are pretty close to signing an agreement in Europe. Nayantara Som     ]]> <![CDATA["We are the only Indian company to have banking facilities abroad,"]]> https://biospectrumindia.com/news/95/1402/we-are-the-only-indian-company-to-have-banking-facilities-abroad.html https://biospectrumindia.com/news/95/1402/we-are-the-only-indian-company-to-have-banking-facilities-abroad.html Thu, 03 Apr 2008 17:06:00 +0530 New Page 1 "We are the only Indian company to have banking facilities abroad," -Dr. C V Nerikar, CEO, Cryobank International India How do view the competition in this space? Here the competition is not with the competitors but the competition is with ignorance. In a country like India where 26 million people give birth, last year the combined banking was not more than 10,000. So I don't think we should be talking about competition. This is the time when the industry should join hands and spread the concern rather than thinking of competition What are some of your diversification plans? Our biggest strength is that we are a very financially sound organization. It is an organization which already has multiple diversified interests and is not completely depending on this business to sustain. Our chairman has plans to invest in hospitals. We have plans of opening up hospitals in some parts of northern and western India. These are the immediate plans in healthcare. We are also looking at a lot of collaborations around research and forward integration of our businesses. We are mainly looking at collaborations around the hospital industry. What has been the quantum of your investments so far? The investments have been somewhere close to Rs 35 crore in our Gurgaon facility and Rs 25 crore in Thailand. We intend to invest almost Rs 500 crore around this business. This would include the facilities and therapy centers. Do you have centers in other countries too? We have one facility in Greece (Athens) and we do about 600 units per month which is pretty good considering Greece is very small. We just started in Thailand and the response is stupendous, we got over 80 clients banking with us and India has been fantastic. But it could have been much better had there been more awareness. We have been catering to Nepal and Sri Lanka and are waiting for our approvals in Dubai and we are looking for a place in Indonesia and Malaysia too. What are your immediate expansion plans? We plan to increase the number of clients from 1,500 to 6,000 this year. We are also in a position to start our new banking facility in Bangkok. We are the only Indian company to have banking facilities abroad. The idea is that if we are able to get as many stem cells from different races, then the probability of matching improves. We are descendents of different ethnicities and races so if you require a particular type of an HLA match then the probability improves the moment you have lots of races, ethnicities and numbers. We are looking at setting up at least 10 such centers in the coming 5-7 years across Asia. We are also planning to set up therapy centers. Our first therapy center should be operational either by the end of this year or by early next year. We are looking at collaborating with a lot of hospitals for taking stem cell research forward. In this direction, we have already signed up certain agreements with few hospitals in some metros. So few hospitals have joined hand with us to start stem cell research project. These would rather be aimed towards cardiac, diabetes and in few cases we are collaborating with doctors working on orthopedic and neurological disorders. We are providing them our expertise in harvesting stem cells and in these cases we are using bone marrow stem cells. We are providing the hospitals with proper technology and they are doing the clinical part of it. We are also now in a position to offer banking of adult stem cells. Jahanara Parveen   ]]> <![CDATA["We would be getting into public banking shortly,"]]> https://biospectrumindia.com/news/95/1572/we-would-be-getting-into-public-banking-shortly.html https://biospectrumindia.com/news/95/1572/we-would-be-getting-into-public-banking-shortly.html Thu, 03 Apr 2008 17:02:00 +0530 New Page 1 "We would be getting into public banking shortly," -Abhaya Kumar, Vice-Chairman LifeCell What are the factors shaping up the stem cell banking industry in India? Stem cell banking is universally an innovative concept which is fast catching the public opinion. The series of success in research in many medical therapeutic applications has given rise to increasing awareness of stem cell banking. Media in all avenues has been playing a vital role in educating the public on the developments on stem cells. What is the size of stem cell banking in India? The current market value of stem cell banking is estimated at Rs 50 crore with active participation from SEC A segment of clients. The growing awareness and the success of applications will certainly make this service affordable and attract other segments within the next five years. We expect this market to touch Rs 500 crore by then. What are some of the challenges confronting this industry? Creating public awareness is one of the major challenges. The concept is well backed by science, technology and research. In India such concepts are thoroughly studied, understood, analyzed and then decided by the public which is a good practice. This may take its time and we don't want people to make impulsive decisions. To facilitate this process, we need to share scientific and clinical information on this subject with the common man which is a major challenge for us. Moreover in certain segments of society health probably takes a back seat over others. But nevertheless, we observe that the priorities are changing with the younger generation and this concept is now catching up fast. We are sure to get an active participation from the public who will be able to decide to bank their child's cord blood on their own in the near future. What is your share of the market pie? The banking sector is currently estimated at Rs 50 crore where LifeCell has more than 60 percent market share with over 10,000 client samples stored and the number is doubling every year. Our uniqueness is that we are an integrated stem cell solutions provider offering storage, research, clinical trials and therapy solutions. What are some of the recent developments at LifeCell? What are your future plans? Launched in November 2004, LifeCell is India's first and largest umbilical cord blood stem cell banking and stem solutions provider to bring the revolutionary medical breakthrough of umbilical cord blood stem cell banking to the country. We have a state-of-the-art stem cell processing and banking facility in Chennai. We have a technology tie-up with CRYO-CELL International (CCI) USA, which has mastered the technology of stem cell banking over the last 18 years. LifeCell is one of the pioneers and leading cord blood stem cell banks in India with a wide network of over 30 sales and collection centers. Moreover in term of international accreditation, LifeCell is India's first stem cell banking company to possess AABB Accreditation (American Association of Blood Banks) for following stringent standards as per international norms in handling, processing, storing, maintaining and retrieval of stem cells and related functions. We have also been recognized by DSIR, Government of India for our research activities. LifeCell is also an Institution that offers therapy solutions through TriCell, an exclusive stem cell center set up in joint venture with Sri Ramachandra University, Chennai. Regarding our future plans at LifeCell, we wish to bring the latest technologies in stem cells through collaborative programs with well established reputed research institutions and biotechnology companies with advanced technology and intellectual property rights. We would be getting into public banking shortly. Umbilical cord lining and adult stem cells are other areas which we are in process of finalisation which should be launched by mid-2008. Jahanara Parveen ]]> <![CDATA[Umbilical cord stem cell banking bandwagon swells]]> https://biospectrumindia.com/news/95/1699/umbilical-cord-stem-cell-banking-bandwagon-swells.html https://biospectrumindia.com/news/95/1699/umbilical-cord-stem-cell-banking-bandwagon-swells.html Thu, 03 Apr 2008 16:34:00 +0530 New Page 1 Umbilical cord stem cell banking bandwagon swells With over 26 million births being registered every year in India, the number of Stem cell banking companies in India is on the rise. Enterprises ranging from India's largest corporate player like Reliance Life Sciences to local non-government organizations (NGOs) are making early investments in setting up stemcell and umbilical cord blood banks across the country. While Cryobanks International, LifeCell, and Reliance have already established themselves in the cord blood and stem cell banking space, regional players are seeing this as a futuristic business option. This year alone has witnessed the setting up of two companies. The Reliance Life Sciences offers stem cell banking services under the "Reli Cord" brand and is known to have direct presence in more than 30 locations. Cryobanks has established its facility in Gurgaon with an investment of Rs 35 crore. The company operates in over 25 cities and hopes to harvest about 6,000 units during 2008. "We plan to increase the number of offices from 25 to 50 by March 2008 and the client base from 1,500 to 6,000 this year," said Dr C V Nerikar, CEO, Cryobanks International India. "We plan to set up about four banks across India in the next three to four years. One would be in Delhi, one in Calcutta, one in Mumbai or Pune and one in South or whichever place suits," he added. LifeCell, in collaboration with Cryo-Cell International, USA facilitates the cryogenic preservation of stem cells at its unique facility in Chennai. LifeCell has set up a 21,000 sq ft laboratory at the cost of Rs 14 crore in the outskirts of Chennai and has more than 30 centers. The company has centers in Dubai and Sri Lanka and plans to open centers in other countries as well. LifeCell has recently inaugurated its area office and collection centre in Indore and by 2009, the company plans to have more than 50 centers to cater to the growing Indian market for stem cell banking. The facility has a capacity to store over 1 lakh samples and conforms to the standards of American Association of Blood Banks and US FDA. The other players operating in this space include Cord Life Biotech, Cryo Stem Cell, and Karnataka Stem Cell. Chennai-based Jeevan Blood Bank is also setting up Jeevan Stem Cell Bank. The main source of stem cells will be umbilical cord blood. IQRA Biotech Services, claimed to be the first human DNA banking company based in Lucknow, UP, also proposes to setup an umbilical cord blood bank by 2008-09. Stem Cell Banks in India Reliance Life Sciences, Mumbai LifeCell, Chennai Cryobanks International, Gurgaon Jeevan Stem Cell Bank, Chennai Karnataka Stem Cell, Bangalore Cryo Stemcell, Bangalore Cord Life Biotech, Pune Apollo Hospital, Hyderabad Advanced Cell Therapeutics, Mumbai IQRA Biotech Services, Lucknow Histostem Inc. USA has signed MoUs with the governments of Maharashtra and Andhra Pradesh. The Potential Based on Frost & Sullivan's findings, the global stem cell banking market size for 2005 was estimated to be $1.02 billion and it is projected that this number would triple to $3.2 billion in 2010, at a compounded annual growth rate (CAGR) of 25.8 percent. Stem cell preservation is a huge business opportunity in the international market and as per estimates the global stem cell market is expected to become $10 billion opportunity over next few years. India, having a very high birth rate, presents a lucrative opportunity for stem cell banking business. With more than 26 million births a year, India is poised to be the largest source for umbilical cord blood in the world. Leading cell banking companies are keenly eyeing India for the potential it carries in this segment and are contemplating to enter the Indian market preferably via joint ventures with local companies. According to industry observers, India has all the essential ingredients to emerge as a key repository of cord blood for companies across the globe. Leveraging the well developed logistics infrastructure, leading companies can create huge storage capacities for their global and Asia-Pacific operations in India, they said. Trends Most of the cord-cell banking companies are increasingly looking at fostering links with medical institutes, hospitals, research institutions and biotechnology companies to aid in stem sell research. "We are looking at collaborating with lot of hospitals for taking stem cell research forward. In this direction, we have already signed up certain agreements with few hospitals in some of the metros," said Dr Nerikar. Many of the stem-cell banking companies have also been focusing on stem cell therapy centers. TRICell is an affiliate of LifeCell and has a therapeutics facility to provide clinical applications under stem cell therapy. It has been set in association with Sri Ramachandra University, Chennai. Cyrobanks is also in the process of establishing a therapy center by the end of this year. At present, lack of awareness among the common people about the huge potential to be gained from the storage of cord blood stem cells and highly technical nature of the process is the key reason for a small customer base in the country. However, the market has tremendous potential that could be tapped by initiating an awareness campaign and a customized marketing plan say players in the industry. Applications Cord blood stem cell transplantation has moved over the last few years from being an experimental procedure to an accepted treatment for a number of hematological diseases and genetic disorders. Researchers suggest that some cord blood cells, present in extremely low frequency, may have the capacity to develop into many different lineages including cartilage, fat cells, hepatic and cardiac cells. Originally stored for the treatment of hematological disorders, these stem cells have now been found to be more versatile, even pluripotent, with potential for use in the treatment of a broader range of disorders and diseases and may be particularly valuable in cell therapy and regenerative medicine.   Potential Indian Patient Population for Stem Cell-Based Therapies Condition Number of Patients Cardiovascular Diseases 58 million Autoimmune Diseases 30 million Diabetes 32 million Osteoporosis 10 million Cancers 8.2 million Alzheimers disease 5.5 million Parkinson's Disease 5.5 million Burns (Severe) 0.3 million Spinal-cord Injuries 0.25 million Birth Defects 0.15 million/year Source: Dr. Vasantha Muthuswamy, Senior Deputy Director General, ICMR ]]> <![CDATA[FDA approvals for biotechs decline]]> https://biospectrumindia.com/news/95/1398/fda-approvals-for-biotechs-decline.html https://biospectrumindia.com/news/95/1398/fda-approvals-for-biotechs-decline.html Thu, 03 Apr 2008 16:26:00 +0530 New Page 1 FDA approvals for biotechs decline The US FDA approvals for biopharma products plunged in 2007. Is the biotechnology running out of steam after many years of great growth in terms of new product development? This is the question on every analyst's mind after a just released study on the approvals of biopharmaceuticals in the last decade, done by Dr Ronald A Rader. For an industry used to getting approvals for close to two-dozen products every year, the year 2007 was dismal with the US government's Federal Drug Authority (FDA) approving only 11 biopharmaceutial products for marketing in the last 12 months. It followed a dismal 2006 when only 10 biopharma products got the FDA approval. Biopharmaceuticals represent a class of pharma products that include recombinant proteins, monoclonal antibodies (mAbs) and some indications of existing drugs to treat various types of cancers. BioPharma product approvals take a dip in the US FDA approvals of biopharmaceutical products have decreased in recent years. This includes recombinant proteins and monoclonal antibodies and cancer therapeutics. In the decade 1996-2005, there were an average of 16.6 approvals per year, while there were only 12 and 11 approvals in 2006 and 2007, respectively. 2007 was a particularly unproductive year. Besides a low level of novelty (with many products similar to prior products), all of the 2007 approvals combined are projected to have less than blockbuster ($1 billion per year) sales (not counting Mircera, which is barred from marketing due to patents), and none will significantly improve healthcare for a large number of patients. Only two recombinant proteins were approved in 2007, a level more typical of the 1980s. The low numbers of approvals in recent years are of particular concern, because a large number of products have been in the development pipeline. It is unclear why approvals have decreased and who, if anyone (FDA and/or industry), deserves the blame for this. Filings for a number of products are pending or expected. So, major increases in approvals are likely in 2008 and 2009. If biopharmaceutical approvals, their novelty and healthcare and economic impact remain at recent and, particularly, 2007 levels, the industry is headed for serious problems, potentially even economic collapse. (Source: Dr Ronald A Rader, author of Biopharmaceutical Products in the US and European Markets. The author is President, Biotechnology Information Institute, Rockville, Maryland, US. More details available at www.biopharma.com) A comprehensive study on biopharmaceutical products in the US and European markets, analyzing the regulatory trends between 1995 and 2007 by Dr Rader, has appeared in the March 15, 2008 issue of Genetic Engineering and Biotechnology News (GEN). Some analysts have blamed the cautious approach adopted by FDA in the wake of recent controversies leading to the withdrawal of several pharmaceutical products from the market after the discovery of unintended side-effects and even dozens of deaths. However, Dr Rader notes that relatively few filings for biopharmaceuticals have been arbitrarily delayed, put on long-term hold or denied. Rather, it appears that fewer products are successfully making it through pivotal phase III trials. Dr Rader reasons that FDA may well be slowing down and shifting its approval criteria to be more restrictive, but most of the biopharmaceuticals affected by FDA delays or denials had problems, usually not attaining their preset primary endpoints in pivotal trials or otherwise having problems with safety or efficacy. The industry will be watching with bated breath the fate of nearly two dozen filings for regulatory approvals from the industry which are currently pending with the FDA. An equal number of filings are expected in 2008 too. Dr Rader's study showed that the FDA approved an average of 16.6 products in the years between 1996 and 2005. The year 1997 was the best ever period for the biotech industry with FDA approvals for a record 23 products, which included 12 recombinant proteins and mAbs. Most of the 11 approvals in 2007 were incremental advances, me-too products, and those with rather specialized indications. Besides a low level of novelty (with many products and their indications similar to those of prior products), none of the 2007 products are expected to significantly improve healthcare for large numbers of patients, emphasized Dr Rader. The 2007 approval with by far the most potential impact, Mircera (pegylated recombinant erythropoietin--PEG-EPO), from Roche, will probably not be sold in the US for at least several years due to patent infringement issues. Without Mircera, a likely blockbuster, the projected market for all products approved in 2007 does not even attain blockbuster level (>$1 billion per year revenue). The low number of recombinant protein or mAb approvals in 2007 (only two) is more typical of the 1980s. And other than a formal approval for Epicel (cell cultured skin patches) from Genzyme, a product already marketed for 20 years, no established or mainstream US biotechnology company received an approval, with approvals primarily granted to large foreign and small, new entrant, US biotech companies. Hardly any mAbs or cancer therapeutics was approved in recent years, despite seemingly endless hype about large numbers in development. No biopharmaceuticals were approved for cancer indications in 2007, only one was approved in 2006, and only one mAb received approval in both 2006 and 2007. New Page 2 BioPharma products approved by FDA in 2008, 2007, and 2006 Product Brand Approval (DD-MM-YY) Company Indication 2008         Fibrin Sealant Artiss 19/03/08 Baxter Healthcare For use in attaching skin grafts onto burn patients Interleukin-1 trap Arcalyst 27/02/08 Regeneron Pharmaceuticals For long term treatment of CAPS disorders Antihemophilic factor Xyntha 21/02/08 Wyeth For hemophilia A Somatropin Accretropin 24/01/08 Cangene Corp. For treatment of pediatric growth failure or short stature Thrombin Recothrom 17/01/08 ZymoGenetics Halt bleeding from small blood vessels after surgery. 2007         EPO, PEG Mircera*, CERA 14/11/07 Hoffmann-La Roche Treatment of anemia associated with chronic renal failure Cultured epidermal autograft Epicel 19/10/07 Genzyme Treatment of wounds resulting from severe burns. Influenza virus vaccine AFLURIA 28/09/07 CSL Prophylaxis against influenza Smallpox vaccine ACAM200 31/08/07 Acambis Prophylaxis against smallpox Thrombin Evithrom 27/08/07 Omrix Biopharma Control of bleeding Fibrin Sealant CryoSeal 26/07/07 Thermogenesis Control of bleeding during liver surgery Immune globulin IGIV, Privigen 26/07/07 CSL BioPlasma Treatment of primary immunodeficiency Influenza vaccine H5N1 17/04/07 Sanofi Pasteur Active immunization against H5N1 influenza virus Somatropin Valtropin 19/04/07 Parexel For treatment of growth Protein C, plasma-derived Ceprotin 27/03/07 Baxter Healthcare Treatment of severe congenital Protein C deficiency Complement C5 mAb Soliris 06/03/07 Alexion Pharma Treatment of paroxysmal nocturnal hemoglobinuria Poly-4-hydroxybutyrate TephaFLEX 12/02/07 Tepha For use as surgical sutures 2006         Albumin (Human)   17/10/06 Octapharma Pharma Restoration and maintenance of blood volume Influenza vaccine FluLaval 05/10/06 GSK (ID Biomedical) Active immunization against influenza EGF receptor mAb Vectibix 27/09/06 Amgen For treatment of metastatic colorectal cancer Iduronate-2-sulfatase Elaprase 24/07/06 Shire (Transkaryotic) For treatment of Hunter syndrome VEGF mAb fAb Lucentis 30/06/06 Genentech For treatment of age-related macular degeneration HPV vaccine Gardasil 08/06/06 Merck Prophylaxis against cervical cancer Somatropin Omnitrope 30/05/06 Sandoz For treatment of growth hormone deficiency Varicella virus vaccine Zostavax 25/05/06 Merck Prophylaxis against herpes zoster (shingles) Glucosidase Myozyme 28/04/06 Genzyme For treatment of Pompe disease Rotavirus vaccine RotaTeq 03/02/06 Merck Prophylaxis against rotavirus Hepatitis B immune globulin HepaGam B 27/01/06 Cangene Post-exposure prophylaxis against hepatitis B virus Insulin Exubera 27/01/06 Pfizer For the treatment of type 1 and type 2 diabetes Immune globulin subcutaneous Vivaglobin 09/01/06 ZLB Behring For treatment of primary immunodeficiency Note: Product may never be launched in the US due to infringement of patents held by Amgen (related lawsuit not yet fully resolved). Compiled by Dr Ronald A Rader from FDA filings Biopharmaceuticals are defined as pharmaceuticals inherently biological in nature manufactured using biotechnology (live organisms). This does not include small molecule or other drugs, but includes biopharmaceuticals irrespective of their regulation as biologics, drugs or medical devices. Narayanan Suresh ]]> <![CDATA[The Nobel Prize in Biology, 1982-2007]]> https://biospectrumindia.com/news/95/1219/the-nobel-prize-in-biology-1982-2007.html https://biospectrumindia.com/news/95/1219/the-nobel-prize-in-biology-1982-2007.html Thu, 03 Apr 2008 15:45:00 +0530 New Page 1 The Nobel Prize in Biology, 1982-2007 During the period 1901-2000, a total of about 190 scientists were awarded the Nobel Prize in Physiology and Medicine. And 58 of them received the Prize between 1982 and 2007. Their discoveries range from basic to clinical research. The following is a compilation the scientists who were awarded Nobel Prizes during the last 25 years and their brief discoveries. 2007: Mario Capecchi, Martin Evans, Oliver Smithies: the technique behind gene targeting and knockout mice. 2006: Andrew Z. Fire, Craig C. Mello: RNA interference â€“ gene silencing by double-stranded RNA 2005: Barry J. Marshall, J. Robin Warren: the bacterium Helicobacter pylori and its role in gastritis and peptic ulcer disease 2004: Richard Axel, Linda B. Buck: odorant receptors and the organization of the olfactory system 2003: Paul C. Lauterbur, Peter Mansfield: magnetic resonance imaging 2002: Sydney Brenner, H. Robert Horvitz, John E. Sulston: genetic regulation of organ development and programmed cell death 2001: Leland H. Hartwell, Tim Hunt, Sir Paul Nurse: key regulators of the cell cycle 2000: Arvid Carlsson, Paul Greengard, Eric R. Kandel: signal transduction in the nervous system 1999: GÃ¼nter Blobel: the discovery that proteins have intrinsic signals that govern their transport and localisation in the cell 1998: Robert F. Furchgott, Louis J. Ignarro, Ferid Murad: nitric oxide as a signalling molecule in the cardiovascular system 1997: Stanley B. Prusiner: Prions, a new principle of infection 1996: Peter C. Doherty, Rolf M. Zinkernagel: cell mediated immunity 1995: Edward B. Lewis, Christiane NÃ¼sslein-Volhard, Eric F. Wieschaus: discoveries concerning the genetic control of early embryonic development 1994: Alfred G. Gilman, Martin Rodbell: G-proteins and their role in signal transduction in cells 1993: Richard J. Roberts, Phillip A. Sharp: split genes 1992: Edmond H. Fischer, Edwin G. Krebs: reversible protein phosphorylation as a biological regulatory mechanism 1991: Erwin Neher, Bert Sakmann: function of single ion channels 1990: Joseph E. Murray, E. Donnall Thomas: development of cell and organ transplantation. 1989: J. Michael Bishop, Harold E. Varmus: retroviral oncogenes 1988: James W. Black, Gertrude B. Elion, George H. Hitchings: important principles for drug treatment 1987: Susumu Tonegawa: genetics of antibody formation 1986: Stanley Cohen, Rita Levi-Montalcini: growth factors 1985: Michael S. Brown, Joseph L. Goldstein: regulation of cholesterol metabolism 1984: Niels K. Jerne, Georges J.F. KÃ¶hler, CÃ©sar Milstein: control of the immune system and monoclonal antibodies 1983: Barbara McClintock: mobile genetic elements 1982: Sune K. BergstrÃ¶m, Bengt I. Samuelsson, John R. Vane: prostaglandins and related biologically active substances Note: Compiled from www.nobelprizes.org and various other internet sites on Nobel Prizes.   ]]> <![CDATA[Cross-border investments, a win-win proposition]]> https://biospectrumindia.com/news/95/2881/cross-border-investments-a-win-win-proposition.html https://biospectrumindia.com/news/95/2881/cross-border-investments-a-win-win-proposition.html Thu, 03 Apr 2008 15:39:00 +0530 New Page 1 Cross-border investments, a win-win proposition (You can get in touch with Mark Ravera at: mravera@strategicpharma.com) Mark Ravera is principal at US-based Strategic Pharma Consulting Group, which provides advisory services to both emerging market and western biopharmaceutical companies. This work makes him a frequent visitor to Asia. Few things in life are constant. But one can guarantee that regardless of the broad economic conditions, CEOs of small biotechnology companies will be stressed about their company's financial situation. However, it appears that the current situation is much worse than usual. I have met with the CEOs of several US and Canadian biotechs over the past few weeks, and they are all trying to deal with a difficult financing environment. The IPO window has been closed for years. As a result, the only exit option for investors is via the company being acquired. And those buy-out deals are much more likely to happen when the biotechnology company has a clinical-stage pipeline. As a result, venture capital has grown scarce for early-stage companies, even for those that have scientifically interesting programs with clear commercial potential. For many of these companies, "scarce" equals to "nonexistent". This should be seen as an opportunity for Asian biotechnology interests to access cutting-edge innovative research programs for a relatively low cost. Every Asian country is looking to develop its own biotechnology industry, but eventual commercial success requires many components, not the least of which is the development of an experience base in high-risk and high-reward drug discovery efforts. These are still relatively early days for biotechnology discovery in Asia. Well-chosen investments in western biotechnology companies, perhaps, could accelerate the process. In North America and Europe, the biotechnology discovery experience base is both broad and deep. Many of these companies have people who bring a track record of being in a well-established biotechnology industry. This experience can be found in management, boards of directors, investors and outside advisors. What is missing, and what Asian interests can bring to the table, is cash, along with a strong interest in learning how to build their own successful domestic biotechnology industries. Many of these western companies are looking for relatively small investments to move their programs into early clinical trials. As part of the investment agreement, Asian companies could obtain regional commercialization rights and also global supply agreements, adding highly innovative products to their portfolios. Of course, managing investments that are geographically distant can be complicated. When I speak with western investors about investing in Asian life science companies, the main objection is one of distance: "How can I keep a close watch on my investment when I am in New York and the company is in India, China, Korea, or Malaysia?" For investments flowing from East to West, that question remains valid. Geographic distance, language and culture are all challenges of such cross-border investments. But while these challenges exist, they are not insurmountable. Some companies have set up corporate venture groups very far from home. Eli Lilly, like essentially all of the global pharmaceutical companies, has a venture-funding group that is tasked with identifying investment opportunities on a global basis. Lilly has gone one step further and established a separate group, Lilly Asian Ventures, which is based in Asia and is focused on opportunities in South-East Asia. Another example of reaching out (geographically) is MP Healthcare Venture Management, which is a joint venture between Mitsubishi Tanabe Pharmaceuticals and Mitsubishi Chemical Corporation. With offices in Boston and San Diego, this fund, like the Lilly Asian Ventures group, is able to stay close to its investments and be more closely involved with its portfolio companies. So while not easy, it is possible to invest far from home, yet stay close to those investments. There will be those who believe that Asian funds looking to invest in biotechnology should invest in Asian companies and not in western companies. But this is not an "either/or" situation. The basic premise of managing an investment portfolio is management of risk through diversification. While investing 100 percent of funds in the home country may be patriotic (and politically expedient), it is not necessarily the best financial strategy. Though the investments may be small by the US biotechnology standards, it would mean significant amounts of money for most Asian healthcare companies. Therefore, investing in western biotechnology companies brings disproportionate risk and will negatively impact a company's internal development efforts. But there are ways to share risk and reward, as many Indian pharmaceutical companies are now doing by spinning out their own R&D divisions. Asian companies interested in making these western investments could partner with banks or sovereign funds, both of which might have room for biotechnology in their portfolios. Imagine Asian-owned funds based in Boston, San Francisco, San Diego and other biotechnology clusters in the US-funds that are partnerships between healthcare companies and banks or government funds; funds that actively invest $2-10 million in the US biotechnology companies that are at or near a value inflection point in their development programs. While the majority of such investments will not be successful (this is, after all, the biotechnology industry!), imagine those that are successful: New therapies, revitalized US biotechnology companies, strong financial returns, technical and commercial boosts for the corporate partner, and access to the latest medicines for the fund's home country (or perhaps the entire Asian region). It sounds like a win-win situation, doesn't it? Mark Ravera is principal at US-based Strategic Pharma Consulting Group, which provides advisory services to both emerging market and western biopharmaceutical companies. This work makes him a frequent visitor to Asia. His industry experience of more than 20 years includes large pharmaceutical R&D, biotechnology start-ups, and Wall Street investment analysis.   ]]> <![CDATA[Contribute to the future of humanity]]> https://biospectrumindia.com/news/95/7774/contribute-to-the-future-of-humanity.html https://biospectrumindia.com/news/95/7774/contribute-to-the-future-of-humanity.html Thu, 03 Apr 2008 15:31:00 +0530 New Page 1 Contribute to the future of humanity (You can e-mail Dr Edison Liu at: liue@gis.a-star.edu.sg) Executive Director of the Genome Institute of Singapore, Dr Edison T Liu, is a physician-scientist who trained with Nobel Laureate, J Michael Bishop. Dr Liu has authored over 220 papers, reviews and book chapters. I have never been more excited about the future of biomedicine given all we know, especially about the genome. At the same time, I have never been more concerned about the survivability of the human species. We have populated the earth so that no frontiers are left; our energy supplies are dwindling, and climate change is challenging our security on all fronts. From now on, humanity will need shift from being exploiters to stewards of our resources. Fundamental to managing our future is harnessing genomic capabilities. We are at an inflection point of discovery in genomics and in human genetics. The confluence of knowledge of the human genome sequence, the breathtaking advances in genomic technologies, comparable increases in computational capabilities, and a maturing knowledge base in systems biology are all making genome-based medicine a reality. But equally stunning are the advances in genomic applications for agriculture and veterinary medicine towards optimizing food stocks; and now synthetic biology towards generating renewable energy. Genomic technologies are becoming the prime tools in solving these problems. Genomic technologies informed by genetic sciences have become the core approach to genetic engineering, systems biology, and synthetic biology. When we consider the medical challenges facing the whole of humanity, they will primarily be in the prevention and treatment of infectious diseases, and in sustaining human performance as our populations grow older. In the future, the challenges of AIDS, emerging pandemics, and drug resistant microorganisms will have a significant impact on the economy and the health of a nation. Just as our forbearers found a solution to the starvation cycles afflicting hunter gatherers through agriculture and mastering storage and preservation strategies, we will need to develop direct solutions to emerging infectious disease and to secure our food sources with limited arable land in order to survive. Similarly, all common afflictions of affluent societies such as type 2 diabetes, cardiovascular disease, cancer, and dementia are ailments of aging. Thus, for humanity to advance, we must find solutions to maintain our productivity in the later years of our life. Improvements in food crop and livestock production will be needed to feed the progressively enlarging masses. We have witnessed this dramatic rise in demand as Chinese and Indians raise their standard of living. Certainly, there are concerns about genetically introducing novel genes into the bio-environment. But this can be bypassed by marker-assisted-breeding where standard breeding is accelerated by using precise chromosomal markers in edible plant species. In the emerging field of synthetic biology, the introduction of entire biochemical and synthetic pathways can generate microbial reactors that can convert cellulose into fuel or algae into biodiesel feedstock. All these possibilities can be realized by genomic strategies and advances in genomic technologies: in genome-wide genotyping and ultra-high throughput sequencing, all accessible at a low cost. When compared to standards of 1990, when the human genome sequencing effort began, the total cost of sequencing has fallen by six orders of magnitude with a proportionate increase in speed. Our ability to assess single nucleotide polymorphisms used to map disease genes are now into the one million SNP per sample range. Taken together, these changes in speed, cost, and comprehensiveness will dramatically change our ability to do genetic-based medicine and plant biology. In the twentieth century, most of the innovation and scientific activity occurred in the west and in Japan. However, in the last 15 years, we have all observed a dramatic change in the global economic and scientific landscape. The emerging economies of India, China, South Africa, South America, Eastern Europe and the Middle East have risen in economic clout and are putting these resources into nurturing scientific talent and in building biomedical research infrastructure. Many governments have the desire to exploit genomic technologies for public health benefits, for capacity building in biomedical investigations, in environmental remediation, and in agricultural advancement. I believe this is a correct strategy. Modularly deployed and cost effective, high throughput sequencing and genotyping approaches can be readily established, and informatics capabilities are accessible and expandable. The technologies can easily be directed to other non-medical applications such as in agricultural development, in animal-live stock management, and in environmental remediation. This was indeed well exploited by Brazilian scientists in Sao Paulo in year 2000 when they leapfrogged into world prominence by sequencing an agricultural pathogen (the genome sequence of the plant pathogen Xylella fastidiosa). So, genomic approaches are cost effective means to raise the scientific profile of a new entrant into competitive biology and to help solve national challenges (Simpson AJ. Genome sequencing networks. Nat Rev Genet. 2001 Dec; 2(12): 979-83). With this real and projected increase in genomic research activity, the need for a global organization that can act as a platform for sharing information and for debate has never been greater. In many ways, like nuclear energy, the possibilities for good are significant, but the dangers the technologies hold can also be fearsome. For this reason, the role of organizations such as the Human Genome Organization (HUGO) is more relevant and important than ever before (http://www.hugo-international.org/). Formed in 1991, HUGO was established by an international community of scientists to advise governments in the sequencing of the human genome and to discuss the social consequences of this knowledge. Now in its 17th year of existence, HUGO is refocusing on two exciting directions--genomic medicine (that extends beyond human disease to environmental remediation and food sustainability) and the emerging economies of the world. As I have argued in this essay, human sustainability will be our paramount challenge and genomic technologies will be a key to this sustainability. Thus the time for Genome Medicine has arrived and the need for HUGO, as a thoughtful and international arbiter, has never been greater. HUGO's second focus on supporting the growth of genomic capabilities in the emerging and developing countries in Latin America, Eastern Europe, Asia, and Africa is timely. The dramatic economic development in most of these emerging economies now is permitting governments to reinvest into science and technology. There is a need for a global organization to help all societies craft the most mature application of genomics in medicine and public policy. Therefore, I invite all my readers to join HUGO and to contribute to the global discussion on genomics and the future of humanity (http://www.hugo-international.org/). ]]> <![CDATA[The drying pipeline]]> https://biospectrumindia.com/news/95/7512/the-drying-pipeline.html https://biospectrumindia.com/news/95/7512/the-drying-pipeline.html Thu, 03 Apr 2008 14:43:00 +0530 New Page 1 The drying pipeline History shows that infusion of new technologies has helped increase farm outputs. It is now time to find the successor to Bt Cotton. Dr KK Narayanan is managing director of Metahelix Life Sciences and President, ABLE, the Association of Biotechnology Led Enterprises. The views expressed here are his own. Ever since the presentation of the Union Budget by our Finance Minister, agriculture has been in the headlines, almost every day. The waiver of farm loans, which would cost the exchequer over Rs 60,000 crore, is the single most significant pronouncement we heard in his speech. The merits of this measure continue to be fiercely debated, especially with a backdrop of a looming general election. The widening gap between the growth in agriculture and the other sectors of the economy, the primary reason for the inequities between the urban and rural India, is under a spotlight. The urgency to bridge this gap is only accentuated by the daily commentaries on the issue by opinion leaders in the media, and the frantic measures being proposed, both by the Central and the State governments, to revive agriculture. But sadly, what is getting lost in this medley of opinions, suggestions and proposed corrective measures, is the role of technology in raising agricultural productivity and consequently, the farm incomes. Recent history underlines the importance of technology in boosting agricultural growth. It was the High Yielding Dwarf Varieties (HYVs) in wheat and rice, a product of genetics and plant breeding research, which ushered in the Green Revolution of the early 70s. From a "ship to mouth" existence, we became self sufficient in food grains. From around 2.5 percent growth rate in the pre-Green Revolution years, crops and livestock production grew annually at an average rate of 3.7 percent, overtaking the growth rate of the population and significantly contributing to the total economy. However, by the 90s, the easy gains through HYVs were already harvested and increases in food production started to slump again, reaching an average annual growth rate of around 1.2 percent from 1990 to 2007, lower than the annual growth of population, which averaged 1.9 percent, in the same period. As a consequence, the per capita availability of cereals and pulses has declined sharply in this period. The situation calls for a second wave of technology infusion in agriculture. Studies in plant biology are opening up new ways of improving crops through novel means of genetic manipulation. Techniques have been refined to develop genetically modified (GM) crops that could effectively address some of the pressing problems in agriculture faced by the country. Huge investments have been made in the public research institutions on transgenic crop research. The private seed industry, though initially apathetic to this promising technology, was quick to catch up. Bt cotton field trials were initiated in the mid 90s through a partnership between a leading Indian seed company and the global leader in plant GM technologies. However, these efforts were severely hampered by the strident opposition to GM crops by activists, who invariably drew their inspiration, and may I add resources, from their friends in Europe. The buffer stock of food grains, which was in the news for being wasted through inefficient storage and handling, was projected as a measure of surpluses, that was never really there, in order to reject the need to increase productivity using GM technologies. A discerning observer however, would have easily seen the impending shortages, resulting in our country actually importing wheat last year to meet its food demand. In spite of all the opposition, Bt cotton got finally approved for commercial cultivation in 2002 after much delay, and an interesting twist of events, which neither the regulatory authorities nor the activists could foresee nor could have any control on. The story of Bt cotton since then, is one of the realization of the promise of GM technologies in reviving Indian agriculture. Importance of technology High Yielding Dwarf Varieties (HYVs) in wheat and rice, a product of genetics and plant breeding research, ushered in the Green Revolution of the early 70s. From around 2.5 percent growth rate in the pre-Green Revolution years, crops and livestock production grew annually at an average rate of 3.7 percent, overtaking the growth rate of the population and significantly contributing to the total economy. By the 90s, food production started to slump, reaching an average annual growth rate of around 1.2 percent from 1990 to 2007, lower than the annual growth of population, which averaged 1.9 percent, in the same period. From a little under 30,000 ha in 2002, Bt cotton area in the country has grown to over 6 million ha, which is almost 90 percent of the total area under hybrid cotton in the country. The cotton production in the country has touched almost 3 million bales (of 170 kg) from 1.4 million bales in 2002. Cotton productivity, which was under 300 kg per ha in 2002 and is now close to 500 kg per ha. India has overtaken the US to become the second largest global producer of cotton! From being an importer of cotton till 2003-04, we are today a net exporter. From a little under 30,000 ha in the rainy season of 2002, Bt cotton area in the country has grown to over 6 million ha, which is almost 90 percent of the total area under hybrid cotton in the country. While the total area under cotton has remained unchanged, the cotton production in the country has touched almost 3 million bales (of 170 kg) from 1.4 million bales in 2002. The productivity, which was under 300 kg per ha in 2002 and is close to 500 kg per ha, now. We have overtaken the US to become the second largest global producer of cotton! From being an importer of cotton till 2003-04, we are today a net exporter. A number of independent studies, including one by the ICAR have shown that the farmer is earning at least Rs 3,000 more per acre by adopting Bt cotton technology, through increased production and savings in pesticide sprays. Pesticide usage in cotton, which used to account for a staggering 54 percent of all pesticides used in country, has seen a drastic fall, not to mention the attending environmental benefits. The most recent economic survey (2007-2008) shows that the production of almost all the food crops slowed down to less than 1.5 percent in the period 2002-2007, way below the projected targets. The only notable exception to this trend was cotton whose production in the same period grew at close to 20 percent per annum, exceeding the targets by a substantial measure. The spectacular success of Bt cotton should have the paved the way for such technologies in other crops. But, this is not happening! There are GM technologies in several other crops that are at least as safe as what is being grown today and with significantly added value to make farming a more lucrative enterprise. However, no one is sure when these would actually be deployed to benefit our farmers. The one question that dwells in ones mind is what's next after Bt cotton? The regulatory approval system, instead of becoming simpler and streamlined with the Bt cotton experience, has actually become uncertain and complicated. The shifting positions and the new and mostly unreasonable testing requirements have not only delayed the release of competing Bt cotton technologies but is holding up valuable technologies in other crops as well. The technology pipeline is right now chocked, and if something drastic does not happen, it may dry up altogether. There are several pending issues that need to be sorted out through reasoned debate and clear positions arrived at. It may be convenient to blame the recent court intervention for this morass, but that does not take away from the responsibility to be clear-headed in laying down the principles of implementing the regulatory system. It should be based on reasoned scientific principles and a common sense approach. Common sense, I am painfully discovering, is not all that common!   ]]> <![CDATA["MNCs will outsource more pharma production to India"]]> https://biospectrumindia.com/news/95/5808/mncs-will-outsource-more-pharma-production-to-india.html https://biospectrumindia.com/news/95/5808/mncs-will-outsource-more-pharma-production-to-india.html Thu, 03 Apr 2008 14:41:00 +0530 New Page 1 "MNCs will outsource more pharma production to India" -Rajesh Jain, Joint Managing Director, Panacea Biotec. Panacea Biotec, based in New Delhi is India's 3rd largest biotech company, and a major player in pharma generics and vaccines. Joint Managing Director Rajesh Jain outlines how some of the recent government measures like 50 percent reduction in excise duty on manufactured pharma goods will spur the growth of the pharma outsourcing industry in India. Excerpts: Will the reduction in excise duty on all pharmaceutical products accelerate or slow down the growth of biotech drugs in the overall pharma pool? I am sure there exists adequate competition in the market, which would ensure that these cuts get passed on to the consumer. I don't think individually any company would benefit. This will lead to more consumption at the consumer level. It is not likely to have any significant impact on the growth of biotech or pharma industry. Is the excise reduction and hence price reduction the main enabler for export growth? Or are there other factors as well that Indian manufacturers have to contend with? Excise reduction is not the main enabler for export growth. From the industry's perspective, there are two clear challenges that lie ahead. One is the foreign exchange management with respect to the risk, keeping in mind the fact that majority of our foreign exchange earnings are on account of exports. Declining export growth and steady appreciation of rupee have been badly hitting the pharmaceutical exporters for more than a year now. We want to grow exports but there is no risk coverage for it. We need freedom or protection from the risk of Foreign Currency Fluctuation. The Government should either allow us to undertake Margin Currency trading from EEFC Account in a foreign bank or protect the rupee rate with foreign currency as being done by Malaysia and UAE. On the other hand, we have a need for new product introduction, especially in a time zone where patent law is fully implemented in India. There is a strong need for new product introduction in the domestic and international markets. India has become fully compliant to the patent law. 'Made in India' label has gained reputation all over the world. What would happen to the manufacturing sector in India when competition from smaller economies like Bangladesh, Sri Lanka, and Taiwan will offer competitive prices against Indian prices? It has now to move quickly in Value Chain from Manufacturing to Innovation. India has to leapfrog from its current image of low-cost manufacturing base to a quality-oriented innovation. Innovation in New Product Development takes a long time of 7-10 years and requires huge investment. This is where the government must come out with some innovative fiscal schemes. For example, we could be given bonds for 10-15 years with a payable period at US LIBOR rates, equivalent to the money spent on R&D by a company for them to plough it back for Research & Development (R&D) of innovative products. Panacea Biotec is now fully determined to change its course from "Imitation to Innovation". Which are the major export markets for Indian companies? They are mainly the developing countries, EU, and ROW countries. Will the budget measures boost the CRAMS sector in India? The CM/CRAMS industry is already booming. Weighted deduction of 125 percent on payments made for outsourcing research services is a welcome offering for the industry as the emphasis on R&D has increased. Due to high quality and low cost advantage, Indian companies are poised to benefit from contract research business.The CRAMS industry has a very bright future, as more and more big pharmaceutical companies, especially MNCs are outsourcing production and research strategically. However, there is a tremendous scope and potential in pre-clinical research and bioinformatics. Will MNCs set up manufacturing facilities in India for re-export? It would be more profitable for them to outsource their production to Indian companies, which are compliant to international regulating agencies like USFDA, UKMHRA, ANVISA, and MCCSA. Were products from India non-competitive in price earlier? Products from India had always been competitive in price. In fact, due to this competition, the prices of drugs are one of the lowest in the world. However, India also needs to come out with Innovative products, but it involves a huge investment, time and risk. Without the willingness and support of the Government, it would be a very difficult task to achieve. Shalini Gupta     ]]> <![CDATA[India boosts CRAMS sector]]> https://biospectrumindia.com/news/95/2210/india-boosts-crams-sector.html https://biospectrumindia.com/news/95/2210/india-boosts-crams-sector.html Thu, 03 Apr 2008 14:26:00 +0530 New Page 1 India boosts CRAMS sector In a significant move, the government of India has slashed the tax levied on pharma products manufactured in the country by 50 percent, reduced the federal value added tax by two percent and extended tax concessions to the pharma and biotech research companies which take up outsourced research works. Some of these measures are likely to spur the growth of the Contract Research and Manufacturing Services (CRAMS) sector in India. Baddi-A Pharma Manufacturing Hot Spot in India For most tourists driving to the Northern Indian hill station of Shimla, 350 km north of Delhi and the former summer capital of India's British rule, Baddi used to be a pit stop at the foothills of the Shivalik mountains before the arduous 40 km winding mountain roads started. A decade ago, the federal government of India gave a special status to the tiny hill state of Himachal Pradesh which allowed tax exemption to manufacturing units set up in the state. The state government quickly set up the industrial infrastructure at Baddi, on the border with the states of Haryana and Punjab and just 40 km from their joint capital city, Chandigarh. Baddi has never looked back since then. Companies in various sectors moved in swiftly and it became a big manufacturing hub. Pharma companies too moved in a big way and there are over 500 manufacturing units of who's who of India's pharma sector. But in one sweep, the current Finance Minister, P Chidambaram, seems to have chipped away at Baddi's advantage by halving the excise duty on pharma goods from 16 to 8 percent all over the country. Analysts feel that this move may make many pharma manufacturers relook at further expansion of production facilities in Baddi. In the past, with profits showing the downward slope and with the steep excise duty, close to 500 drug units from Maharashtra, Gujarat and Andhra Pradesh (their traditional base) moved their production units, catering to the domestic market, to the tax-free zones in Himachal Pradesh, Uttaranchal and Jammu & Kashmir. Industry analysts estimate that 200-odd large and medium units from these states have already moved to Baddi in Himachal Pradesh since 2004. Another 300 units in Uttaranchal and Jammu & Kashmir, making these locations account for over 65 per cent the country's $11.3 billion pharma production. The major attractions for investors included 100 percent outright excise duty exemption for a period of 10 years from the date of commencement of commercial production (the past budget stipulated it to industries starting on or before March 31, 2007), 100 percent income tax exemption for an initial period of five years and thereafter 30 percent for companies for a further period of five years, capital investment subsidy of 15 percent on plant and machinery, applicable also to existing units. Baddi, according to an investment review by the Himachal Pradesh industry ministry, had received an investment of over $250 million in the pharma sector. Another $225 million is being invested by 20 leading Indian pharmaceutical companies. Amendments in the value added tax (VAT) collection rules in Maharashtra has worsened the scene for the drug units based there. Mumbai-based major companies led by Wockhardt, Cipla, Lupin, Sun Pharma, Alkem, Aristo, Nicholas Piramal and a few others have already set up their plants at Baddi. In Gujarat, the scenario was even worse. Cadila Healthcare (Zydus), Torrent, Alembic, Intas and a few others are in the process of moving to the northern states. Major players from Andhra Pradesh--Dr Reddy's, Natco Pharma, Aurobindo and several others--have moved to the new location. With the new budget measures, companies now might look out for newer avenues and this in the long run does not spell good news for Baddi. The unveiling of the federal government's budget for the forthcoming financial year, on the last day of February has been a century-old tradition in India. For it provides the Finance Minister an opportunity to play to the galleries and favor the industries he likes and punish those whom he hates by his taxation measures. Many of the country's path- breaking changes that impact the economy have been unveiled during this exercise which is a big media spectacle too. So the show was on air on February 29, 2008 and India's Finance Minister, P Chidambaram opened his goodies bag at 11 a.m. And one of the beneficiaries of the government's kind attention this year has been the pharma and biotechnology sectors.Especially for the industry which was crippling under the obsolete price regime, increasing competition and rising cost in raw materials. India's emerging role as being the preferred destination for drug development coupled with an increasing need to bring down drug prices have been the key factors in this year's budget sops. "The sops have come as a pleasant but welcome surprise and have more than met industry expectations," commented Dr Kiran Mazumdar-Shaw, CMD of Bangalore-based Biocon Ltd, India's No. 2 biotech company. Most importantly industry experts, looking in hindsight predict that the budget will have a major impact on the manufacturing segment of the industry with reduction in excise duties, federal sales tax, and reduction of customs duty on life saving drugs. "This is a very unique budget that shows fiscal responsibility and gives the right impetus for manufacturing, research and development and also expands the scope of Public-Private-Partnership. I give a 10 out of 10 to this budget," opined Habil Khorakiwala, chairman, Wockhardt Pharma, Mumbai. It is a good signal that the biotechnology and pharmaceutical industry does occupy an important space in the Government's yearly budget agenda. The booming manufacturing industry The manufacturing sector has always had an important bearing on the overall growth of the Indian biotechnology industry. This is exactly what the Finance Minister has taken into consideration in this year's budget. Indian companies like Biocon, Bharat Biotech, Biological E, Serum Institute and Shantha Biotechnics have world-class facilities for biopharmaceutical manufacturing. Earlier there was some reluctance to award contracts to Asian biopharma manufacturers because of concerns of IP and regulatory compliance. But now some of the Asian countries are changing and becoming very competitive in biopharma manufacturing. "Indian firms are expanding and scaling up manufacturing capacities to become global players and the West is increasingly becoming comfortable with the IP, quality, regulatory filings and the infrastructure here," said Gautam Das, COO, Syngene, the Bangalore-based Biocon Group's CRAMS unit . Shasun Chemicals, Suven Life Sciences, Strides Arcolabs, Jubilant Organosys, Orchid Pharmaceuticals and many other large Indian companies have started undertaking contract manufacturing of APIs as part of their additional revenue stream. Top MNCs like Pfizer, Merck, GSK, Sanofi Aventis, and Novartis are dependent on Indian companies for many of their APIs and intermediates. Take the instance of some of the top-manufacturing units. Serum Institute of India, Pune, is widely recognized as a world-class contract manufacturer and is able to deliver a wide range of products and clinical assistance to companies on a competitive basis. In particular, Serum Institute has developed the complete process of fermentation, purification and manufacture of polysialic acid for Lipoxen PLC, a UK-based biopharmaceutical company specializing in the development of differentiated biologicals, vaccines and anti-cancer therapeutics drugs, which entered into a Development and Manufacturing Agreement (DMA) with the Serum Institute of India. Pursuant to the DMA, Serum Institute develops the technology for the manufacture of polysialic acid and its derivatives, complying with USFDA standards on a commercial scale to meet the demands of the company's collaborative partners and for pre-clinical and clinical trials purposes. Oncological products for the US and EU markets are also expected to be manufactured at the new facility. Similarly, Wockhardt has a contract-manufacturing relationship with Amylin and many other leading pharmaceutical companies, such as Aventis and AstraZeneca. It has manufacturing plants in India and the UK, which are certified by the USFDA and the UK's MHRA. Jubilant Organosys, the largest player in pyridines worldwide, has signed a multi-million dollar long-term agreement with Syngenta for the supply of pyridines. The new contract will begin from early 2008 and it will cover an extension period of up to five years, during which Jubilant will continue supplying the products to Syngenta. Recently Jubilant expanded its production capacity for pyridines and picolines to 42,000 TPA and this contract with Syngenta would significantly improve the use of the additional capacity. Against this background, the measures will be a big boost for these manufacturing units growing at an astounding pace. "All in all the pharmaceutical companies irrespective of size, scale and geography will largely benefit from these measures," said Utkarsh Palnitkar, Partner & Industry Leader, Health Sciences Practice, Ernst & Young, Hyderabad. A report prepared by a leading investment bank mentions that the positive impact will be seen on stocks of companies like Panacea, GSK, Ranbaxy, Sun Pharma, Biocon, Cipla and Matrix. The report further states that increase in budget allocation for polio elimination program $250 million and for AIDS control program $240 million could be positive for companies like Panacea Biotec, Matrix, Ranbaxy, and Cipla. With the excise duty on all goods produced in the pharmaceutical sector reduced from 16 percent to 8 percent, pharma manufacturing units are sure to witness a positive impact in their productivity. "Reduction of excise duty to 8 percent on all drugs and custom duty on life saving drugs to 5 percent should result in reduction of manufacturing costs and affordability of drugs. This may in turn spike the demand and may lead to higher growth for whole sector," added Hitesh Sharma, Partner, Health sciences Practice, Ernst & Young. The announcement of allocation of funds for the polio eradication and control of HIV/AIDS is a positive sign for companies like Cipla (which has a strong presence in the manufacture of anti-AIDS drugs) and Panacea Biotec. In fact, AIDS has always been on the priority list for the governments in the past. For two consecutive years between 2003 and 2005, the government had introduced exemption of excise duties on anti-AIDS drugs along with other life saving drugs. The Union Budget has a number of positives for the pharma biotech industry, mainly the reduction of Cenvat to 8.24 percent, the 125 percent weighted deduction to outsourced research, reduction in customs duty on raw materials for ELISA kits to 18.72 percent and select vaccines and select bio-therapeutics to 9.36 percent. "The Life Sciences sector particularly has a lot to benefit across the spectrum. These measures will provide a great impetus to the industry. The decrease in excise duty was a long standing demand which has been met. The withdrawal of excise duty on life saving drugs and reduction of customs duty to 5 percent on these drugs was eagerly sought and this is another demand of the pharmaceutical sector that has been addressed by the Finance minister," added Ernst & Young's Palnitkar Biotech industry association, ABLE sees many positive outcomes for the biotech industry. It stresses that the 15 percent increase in the allocation for the health sector should be a good boost for the pharmaceutical sector of the biotech industry which should result in increased usage of biotechnological products like vaccines. Several reliefs provided in the taxation proposals are also seen as generally positive. The reduction in the CENVAT rates will provide a boost to all manufacturing activities, including those in this sector. Commenting on the budget Dr KK Narayanan, President of ABLE and the Managing Director of Metahelix said, "The weighed average deduction of 150 percent on R&D that has been extended to seed production activities will provide relief to the seed companies of the bioagri sector of the industry" Diagnostic manufacturers hit Manufacturers in the biotech space will be hit slightly. Take the instance of Tulip Diagnostics which had recorded sales of $42 million in 2006-07. About 55-60 percent of the company's revenues come from international markets. "We have two key issues. With the dollar weakening against the rupee, we have lost about 10-12 percent in revenues in terms of the dollar value. There is nothing in the budget which looks into the fall of the dollar. China is able to do it inspite of current aggregate surplus demand and dollar surplus but India with only 1/7th of dollar surplus is still letting the rupee fall," said DG Tripathi, MD, Tulip Diagnostics. TransAsia BioMedicals, whose sales stood at $38 million last year, was also at the losing end. "The exchange rate is very high and in the last 18 months we lost about 20 percent of the business on competitiveness. Further, the shooting salaries because of shortage of trained manpower have put us in a tight spot," said TransAsia's MD, Suresh Vazirani. India-China: The Past and the Present The uncompetitive nature of the Indian pricing structure had given its Chinese counterpart the upper hand. China was and still continues to be the first preference of choice for global companies. "China rules the roost and continues to be the kitchen for the US market," observed an expert. A Mckinsey Quarterly clearly mentions, that post 1980, China grew at a lightning speedy and pushed forward its GDP growth on the basis of its manufacturing industry. GDP growth had increased to 9 percent in 2003 from 8 percent in 2002. It used its domestic savings to build its infrastructure and attracted foreign investment to build factories and the expertise. Chinese biotech industry has a strong back up with companies in the US. Added to this, there are a lot of Chinese scientists settled in the US and they are taking back a lot of investments into China and further linking the Chinese low manufacturing units to high revenue markets in the US. India never enjoyed this advantage. Hence as far as pricing issues are concerned, China always had the edge over India. Said Tripathi, "In China, all the biotech companies are given a subsidy of 25 percent. So a vendor is assured of a 25 percent subsidy. In India, there is nothing like that. We are penalized for everything. We are taxed heavily. Almost 61 percent of our revenues go into taxation." "Until China came into the scene, we were quite competitive in the scenario. The competition was from the US and Europe. With China coming into the scene, we have become less competitive and not as strong as before," added Vazirani. The government's role has a major influence on development in both the countries. The Chinese government takes a keen role in deciding on the course that the companies should take, funds the industry, and is open to foreign investments. China has a strong manufacturing base today only because the government strongly supported it actively. In India, companies have emerged either because they were family owned or from the sheer spirits of entrepreneurship without much government support. In India, there is an urgent need for public-Private Investments (PPI). Moreover, till recently India has also been at a major disadvantage due to the appreciation of the rupee vis-vis the dollar rate which is a big blow for companies majorly into exports. This is one point again which the budget should have taken into account.   Narayanan Suresh with inputs from Shalini Gupta (New Delhi), Jahanara Parveen (Banglaore) and Nayantara Som (Mumbai)   ]]> <![CDATA[Knowledge Nation Is Here]]> https://biospectrumindia.com/news/95/1301/knowledge-nation-is-here.html https://biospectrumindia.com/news/95/1301/knowledge-nation-is-here.html Tue, 11 Mar 2008 15:57:00 +0530 New Page 1 Knowledge Nation Is Here The $1 trillion Indian economy is on the threshold of a major transition. The transformation from an agrarian to a knowledge economy, by and large sidestepping the intermediate stage of full scale industrialization, is taking place at a quick pace. Nothing illustrates this better than the budget proposals, unveiled with great flourish, by Finance Minister Palaniappan Chidambaram on February 29, 2008. The government plans to set up 16 centrally-funded universities, more than double the number that exists today after over 60 years of the nation's independent existence. Three more Indian Institutes of Technology (IITs) will join the network which has won global acclaim in recent years for providing the key human resources fuelling the global technology boom. Also on the anvil are two more clones of the Bangalore-based IISc, called Indian Institutes for Science Education and Research. Quality education is the foundation on which the emerging knowledge economy will be built. The Manmohan Singh government, helped by the overflowing coffers filled up by tax payers, has finally opened up the nation's treasure chest to further fuel the growing economy. The 20 percent higher allocations for the education sector will go someway in addressing the growing industry's cry for human talent. Biotech industry will be a major beneficiary of the government's new found enthusiasm for the higher education sector. For, the central universities such as JNU, universities of Delhi and Hyderabad, the IISc and other centers of higher learning have provided the key talent required by the biotech industry. The 16 new central universities will add to the skilled talent pool needed by the emerging knowledge industry. Another heartening development is the decision to invest Rs 100 crore to set up a National Knowledge Network to link all the top educational institutions using high speed, broadband internet connections. Such a network will lead to an explosion in the creation, sharing and dissemination of knowledge between these institutions. Learners across the country will have access to the best practices and innovations are only bound to increase with the breaking up of geographical barriers between knowledge centers. Chidambaram has helped the life sciences sector in other ways too. He has announced a 50 percent reduction in the excise duty on all pharmaceutical products. It will bring down the prices of essential drugs and increase access to the needy patients. Despite the presence of a globally-watched generics pharma industry, access to quality health care has been a major issue in the country so far. The decision to provide five-year tax exemption to health care centers which will be set up in tier-2 and tier-3 cities aims to further improve access to quality healthcare in the new growth centers joining the nation's economic mainstream. In the last decade, top life science companies have started making major investments in new drug development, instead of relying only on generics. The long gestation periods involved in drug development have not enthused the investors and many of the listed companies had announced their intention to hive off their R&D units in 2007. The doubts about whether these R&D units could enjoy the tax concessions offered to in-house research units have been clarified. The budget proposal to extend 125 percent weighted tax deduction to outsourced research activities will accelerate the trend of setting up pure play R&D centers in the life sciences sector. Five years ago, BioSpectrum started in a small way, and it has been an enjoyable journey so far. The magazine has carried forward the tradition set by CyberMedia (publishers of BioSpectrum) 25 years ago to play a key role in building a knowledge nation in India. Five years ago, the magazine had a long wishlist to the finance minister. Five years later, the list itself is very small. After February 29, 2008, the wishlist will be even smaller. One of the long-pending demands is tax exemption for international patent filing costs. This means that the nation has responded to the needs of the emerging knowledge industry in recent years very well. India as a knowledge nation will soon be a reality.   <sureshn@cybermedia.co.in> ]]> <![CDATA[CMOs: A robust growth trend]]> https://biospectrumindia.com/news/95/2355/cmos-a-robust-growth-trend.html https://biospectrumindia.com/news/95/2355/cmos-a-robust-growth-trend.html Tue, 11 Mar 2008 15:52:00 +0530 New Page 1 CMOs: A robust growth trend The extent to which outsourcing can be done is quite extensive, so much so that there have been propositions of a virtual company where the company will be in the sole possession of intellectual property and run by a handful of people. This actually is not a farfetched idea, in a few years it maybe a reality. For now, CMOs in Asia are on a rollicking growth path The pressure to reduce or maintain costs, while increasing productivity, has been the driving force in outsourcing in the life sciences sector. Outsourcing is happening across the whole spectrum- in the pharmaceuticals and biotechnology sector right from drug discovery research, preclinical studies, clinical trials, manufacturing, packaging, distribution to even sales and marketing. In the medical devices area outsourcing is happening in design, component manufacturing, device assembly, (from individual components) and supply chain management (in the form of packaging, warehousing, sterilization). The contract manufacturing outsourcing (CMO) market growth continues to be driven by its attractiveness to the small and emerging biopharmaceutical companies, which do not have the resources to invest in manufacturing capacity. Global biopharmaceutical contract manufacturing is poised to grow from $2.45 billion in 2007 at a CAGR of 14.9 percent between 2007 and 2014, according to market analyst firm Frost & Sullivan. North America continues to remain the primary demand driver for contract manufacturing. Europe and Asia are emerging as strong contenders, with significant new capacity being added in Asia, states Amit Ghosh, pharmaceutical consultant at Frost & Sullivan. Asia Pacific offers a significant cost advantage with outsourced research or manufacturing savings that can range from 50 to 80 percent. This is likely to boost the volume of outsourced work to this region. Ghosh forecasts a definite growth in the CMO for all sectors primarily generics, biopharmaceuticals and medical devices. Asia will continue to hold its lure with low production costs; increasing reliant manpower; local governments' incentives to lure CMOs in their respective countries; implementing stronger IP laws to assure companies of the viability of producing /outsourcing to their countries; and expanding healthcare markets in the growing economies. In the ensuing pages BioSpectrum brings you an overview of some of the key countries in Asia Pacific region where the companies engage to outsource and do contract manufacturing. Coming to specific outsourcing areas, both pharmaceutical and medical devices companies outsource heavily in the manufacturing, packaging and distribution but areas like R&D, sales and marketing-activities which are considered to be their core competencies-are kept under close control. In fact, most of the big pharma companies find that offshore outsourcing in some areas like manufacturing or packaging, distribution or clinical research has a synergistic effect in their overall vision of entering newer markets faster with minimal investments. The extent to which outsourcing can be done is quite extensive, so much so that there have been propositions of a virtual company where the company will be in the sole possession of intellectual property and run by a handful of people. This actually is not a far fetched idea, in a few years that level of sophistication maybe a reality. Systemic catalysts for growth of outsourcing in Asia are stable government regimes, rising healthcare funding by the governments, better IP protection being promised and implemented by the governments. China In the last decade, China has begun undergoing a series of changes with which, healthcare provision must keep-up in order to ensure that the patient population needs' are satisfied. The Chinese population is aging; hence there is an increase in the number of patients solely dependent on government healthcare funding. The Chinese government is attempting to invest in the state-of-art medical devices and pharmaceuticals. The biggest issue for companies outsourcing manufacturing to China is intellectual property protection, which the Chinese government seeks to address through implementing tighter controls when introducing better IP laws. China's move to join WTO encourages a positive perception of the country among the foreign companies. The CMO sector in China is set to increase by leaps and bounds in the coming years, showing a very rapid increase in the number of players. It could pose a serious challenge to India in the coming years. The Chinese government has begun to support and encourage this sector, through implementation of a solid regulatory framework to instill confidence among outsiders. Generics Chinese bulk drugs and API producers are among the largest in the world and are known for their lower prices, but in terms of generics they are still quite far behind India. This is because India started quite early in the generics production scenario, whereas the Chinese drug manufacturers concentrated on APIs. In this sector of CMOs for generics, China though a late bloomer is poised for a rapid growth in the next 10 years, serious enough to pose a challenge to India. Zhejiang Huahai Pharmaceutical was the first Chinese company to get FDA approval in 2007 and will be exporting its finished drug to the US by 2012-when the patent held by Boehringer Ingelheim GmbH for the AIDS drug nevirapine expires. By charting its development, we can safely say that it will take a long time before China can catch-up with India, which is about 10 times bigger in terms of exporting generics. But given China's expertise as the world's largest producer of raw materials for drugs and manufacturing, this is surely a stepping stone for the country to make waves in generics outsourcing. Also, looking at the fact that about 40 percent of the existing production capacity of pharmaceutical producers remains unutilized at the moment, it can be said that the capacity to become an outsourcing powerhouse for generics does exist in China. Biopharmaceuticals At present about 40 percent of the production capacity of pharmaceutical producers with China is lying idle. These companies need newer sources of revenue to expand and remain viable, which can be used for biopharmaceuticals manufacturing. The demand for biopharmaceuticals is growing within China and elsewhere in the world. So, the venture into biopharmaceutical production is an option being considered by many of these producers now. Though the output of biopharmaceuticals from China is insignificant at the moment, the potential market in the near future is expected to be large. While considering exports to western countries, the primary challenge faced by the Chinese companies right now is the stringent quality norm requirements of western companies and governments. They have to modify their facilities and train their staff to meet the requirements of the western companies and agencies, including the FDA cGMP or EU COS certification. As of now, very few Chinese contract manufacturers have managed to get this kind of certification. The Chinese government and the industry is pushing for these standards, which will lead the players to quickly capture the growing segment, not just in China, but worldwide as contract manufacturing of other companies looking to produce cheaply in China. Some of the companies at the forefront of the biopharmaceutical uptake are Beijing BaiAo Pharmaceutical, Beijing WanTai Biological Pharmacy Enterprise, National Vaccine & Serum Institute, Shanghai CITIC GuoJian Pharmaceutical, and Shenzhen Neptunus Interlong Biotechnology. Medical devices China is one of the fastest growing areas for medical devices; both in terms of domestic and foreign sales into China and production from within China for export purposes. China became the eleventh largest market globally for medical devices in 2004, accounting for approximately $3.5 billion. The medical devices industry is mainly located in the eastern cities of China. These include Beijing, Guangzhou, Shanghai and Tianjin. High levels of demand in these areas further promote the industry. It is thought that over 250 medical devices companies have operations in China, yet are headquartered remotely across the globe. The Chinese government has set up Special Economic Zones (SEZs), which encourage establishment of businesses by foreign companies by offering tax reductions. The CMO sector for medical devices in China is also set to increase in the near future, with companies adopting and understanding the high levels of sophistication required for production of medical devices The CMO sector for medical devices in China is also set to increase in the near future, with companies adopting and understanding the high levels of sophistication required for production of medical devices. There are a good number of companies already doing contract manufacturing for exports, but the exact figures are difficult to come by. The problems faced by the western companies are similar to pharmaceutical producers of west, such as the issue of IP protection, and quality issues, however, as costs take precedence the rise of contract manufacturing in China is inevitable. Also, lowering profit margins of other machineries and toy manufacturers is forcing these players to look at medical devices as a future source of revenues.   Malaysia Malaysia has one of the highest government expenditure on healthcare, which is about three percent of the GDP. Its healthcare industry is considered to be one of the best in the region and attracts a substantial number of medical tourists. Country's 90 percent of the expenditure on public healthcare is funded by the government, clearly presuming that generics in Malaysia is also on the rise. This doesn't seem to be the picture in reality though. Both prescriptive drugs and generics don't seem to illustrate growth due to lack of regulations and enforcements. Generics sold in pharmacies in Malaysia are quite regularly found to be counterfeits, causing a great deal of concern within the government. In order to regulate and control the use of pharmaceuticals the government has come out with standards and guidelines such as the use of particular holograms for drugs approved by the government. There is also encouragement to the companies with "standard of practice" and incentives to set up base in Malaysia, some of which are: Income tax exemption of 70% or 100% on the statutory income for five years, or Investment Tax Allowance of 60% or 100% on the qualifying capital expenditure for five years, or Reinvestment Allowance of 60% on the qualifying capital expenditure for 15 years Some other General Incentives Industrial Building Allowance Infrastructure Allowance Import duty exemption for: raw materials/components; and equipment and machinery. Generics & biopharmaceuticals Currently, CMO for biopharmaceuticals is minimal in Malaysia as most drugs (both branded and generics) are mostly imported, even with the presence of some mid-sized pharmaceutical producers in the country. In February 2006, Malaysia got its first biopharmaceutical plant with current Good Manufacturing Practice approval. The company Inno Biologics Sdn Bhd was a turnkey project from Malaysia, a plant built in Germany with assembly done in Malaysia. Contract manufacturing to other pharmaceutical companies is one of the many services offered here. The future of CMOs is likely to improve in Malaysia, as the government is encouraging the use of generics in its healthcare system. The expected outcome in the coming years will be contract manufacturing mostly for local consumption in Malaysia, and export to a few neighboring countries, because most pharmaceutical companies will find it prudent to outsource to countries like India or China, because of costs. Medical devices Malaysia is a well-known name in the medical devices sector, with current revenues estimated at $1.4 billion, and is expected to grow at eight percent for some years to come. It happens to be the highest exporter of surgical gloves and catheters. Medical device companies use Malaysia as their global base for developing, manufacturing and marketing a wide range of products and services-from single use products, equipment and diagnostics to packaging and sterilization. Malaysia offers the lower end spectrum of medical devices, using rubber and plastic components in the majority of the manufacturing done here, although being a net importer of high-end medical devices. There are about 170 medical devices companies in Malaysia, with a handful of them carrying out contract manufacturing for export purposes. The CMO sector for these products is set to rise in Malaysia with a decent procurement from global players. Also another parallel trend seen in the devices manufacturing in Malaysia is the setting up of wholly owned manufacturing units by global manufacturers like Braun, 3M, Ansell and others. Thus Malaysia is poised to offer a bright future for both company owned manufacturing and CMOs in the years to come. Singapore Regionally, Singapore offers the best benefits to companies willing to outsource in terms of experience, track record, IP protection, regulatory compliance and strong incentives. On the manpower front, Singapore excels in the region and this can be gauged from the country's serious focus on managing skilled talent pool, comprising researchers, scientists, engineers and technicians. This makes up about 93 full-time equivalent researchers per 10,000 labor force, which is on par with many developed countries like Sweden, Japan and the US. Singapore has attracted numerous leading medtech companies to its economy and has encouraged them to establish commercial operations, R&D centers and manufacturing facilities. Some of the notable names in the Singapore contract manufacturing scenario are CEI Contract Manufacturing Limited, Encus International, Eng Tic Lee Achieve, Forefront Medical Technology, Interplex Singapore, Inzign, John While Springs, Nano Technology Manufacturing, Racer Technology and Rayco Technologies. Generics Generics form 10 percent of the pharmaceutical industry in Singapore. Due to its small population, the consumption of generics as a whole is quite insignificant. With the progression of aging population and decrease in government funding being two crystal clear incentives to develop more generic drugs, nevertheless overall uptake of generics is not very lucrative for most companies in the country. Existing companies are facing tight competition in margins. The contract manufacturing sector for generics is not poised for a growth in Singapore, since it will be for the local market. Biopharmaceuticals Singapore has some of the big names in contract manufacturing like A-Bio and Lonza, manufacturing for the likes of GSK, Genentech, and Novo Nordisk. Some pharma giants like Schering Plough and GSK are pretty convinced by the investment incentives in Singapore, and they have moved forward to set up their own manufacturing base here. Singapore already has a reputation as a trusted site for bulk drugs and secondary products, and the country now aims to become the outsourcing hub for biologics. And its basics serve Singapore well on its path to achieve that status. Many outsourcing majors in developed countries will unhesitatingly come to Singapore as compared to India or China as they are convinced with Singapore's IP protection laws. The CMO scene for biopharmaceuticals in Singapore is set to grow with the recent government initiatives and also the growing confidence of manufacturing companies in the technical capability of its skilled manpower. Companies will also be sold on the strong IP protection provided and the close proximity to ASEAN countries. Medical devices Singapore always had a very advanced electronic manufacturing base. This has augured well in its becoming a center for medical device manufacturing. With increasing sophistication in medical devices, in the form of small electronics components being introduced into every kind of medical device, Singapore was well positioned to take up the challenge in its stride. As contract manufacturers from Singapore have been very aggressive in promoting their services abroad, medical devices' CMOs may find that Singapore fits their requirements for producing highend devices. However, high cost of production in Singapore is a cause of concern for people looking to outsource. Most medical devices companies have their regional offices and distribution centers in Singapore, also proximity to big markets in the ASEAN region was very well suited as a base for exports into these countries. But, the trend for medical devices' CMOs in Singapore is not towards growth, the growth expectations can at best be described as modest. Singapore government's own agenda of becoming a big player in the medical tourism market will lead to Singapore being a vibrant market for medical devices, but how much of that will lead to contract manufacturing in Singapore remains a big question. It is quite likely, that the CMO sector for medical devices in Singapore will remain confined to hi-end devices requiring a good degree of technical manpower.   Australia ustralia is one of the richest healthcare markets in the Asia Pacific region and ranks as the 11th largest in the world. Per capita spending is on a par with European markets such as Germany and the Netherlands. Local manufacturing is high tech, but tends to be fragmented and small-scale. A few multinationals, such as GSK, have major facilities in the country. Much of the market, however, is supplied by imports. The contract manufacturing outsourcing in Australia is not a major force in Australia, primarily because of the small size of the market and its lack of appeal of being an export hub, vis-Ã -vis, the Asian CMO scene. Biopharmaceuticals and generics The Australian government has supported and encouraged the development of contract manufacturing; Australia is not a big market for generics, though the generics are priced very competitively. The cost of branded drugs in Australia is not very high, so it is an impediment for the generics market. There are a few big local players in the generics market in Australia, so the trend of CMO for generics is very low growth. For biopharmaceuticals the government wants to encourage the local production of biological drugs. In 2006, the government granted $10 million for the establishment of mammalian cell production facility, where local companies can produce their small batches of complex biological material for clinical and pre-clinical studies. Prior to that, these used to be done in Singapore or even the UK and the US. So, the trend for CMO, in Australia is for local consumption, instead of exports. Medical devices The medical devices sector in Australia, comprises local small-to-medium sized enterprises (which often possess a niche product), including both domestic initiatives and subsidiaries of global companies, importers and distributors, the players are not very active in CMO, whatever manufacturing is done, is for the local consumption in Australia.   Amit Ghosh (Amit Ghosh is Frost & Sullivan's pharmaceutical consultant for Pharmaceuticals and Biotechnology in South East Asia. Amit has managed about 15 healthcare projects in South East Asia with a focus on studying for several prestigious clients like Novartis, Sanofi-Aventis, MSD, BMS and Pfizer. His area of focus is best practices and competitive intelligence in the pharmaceutical field.) ]]> <![CDATA["India and China show tremendous economic prospects and increasingly we are seeing greater interdependence"]]> https://biospectrumindia.com/news/95/1489/india-and-china-show-tremendous-economic-prospects-and-increasingly-we-are-seeing-greater-interdependence.html https://biospectrumindia.com/news/95/1489/india-and-china-show-tremendous-economic-prospects-and-increasingly-we-are-seeing-greater-interdependence.html Tue, 11 Mar 2008 14:31:00 +0530 New Page 1 "India and China show tremendous economic prospects and increasingly we are seeing greater interdependence" -Hu Kun Ping, vice-president, Reed Sinopharm Exhibitions, China Reed Sinopharm Exhibitions (Reed Sinopharm) is a joint venture between Sinopharm, the largest state-owned pharmaceutical group in China, and Reed Exhibitions. Reed Sinopharm covers the entire supply chain and is dedicated to the medical, pharmaceutical and healthcare industry sectors. Excerpts of an interview with Hu Kun Ping. Presently what are the market dynamics in the pharmaceutical sector in China? According to industry publication, Medicine Economic News, China is the hotspot for the global bulk pharmaceutical market with 22 percent world market share, a growth rate exceeding 15 percent with annual sales of approximately $70 billion, and export turnover of USD 600 million. It is the second largest market for active pharmaceutical ingredients (API). The rising middle class and living standards in China have resulted in an enormous demand for pharmaceutical products. The Economist Intelligence Unit reports that China's total pharmaceutical sales will be doubled to $28.3 billion by 2010. Surging global demand for better quality yet cost-effective pharmaceutical solutions is making foreign direct investors eager to tap into China's extensive labor market and profit from this bullish economy. According to the latest report released by the China Pharmaceutical Industry Association (CPIA), almost half of the top 100 drug-manufacturing enterprises (based on sales figures) are foreign-invested entities or Chinese-foreign joint venture organizations. Of the top 10, seven companies are foreign-invested enterprises while only three are domestic manufacturers. This clearly demonstrates the fact that international players are taking up a bigger piece of the Chinese pharmaceutical market pie. What are the plus points of the Chinese pharmaceutical market? China offers international pharmaceutical conglomerates a rich plethora of cost-effective and quality raw materials, and an opportunity to leverage the country's rapidly growing biotechnology, natural ingredients, CRO (Clinical Research Organization), and outsourcing sectors. Because China boasts strong manufacturing capabilities and a highly-skilled workforce, an increasing number of multinationals are setting up research and development centers in the region. In addition, the market outlook for formulations exports is positive and will be one of the major trends shaping this industry. Please share what you feel about India and China's emerging pharmaceutical markets. Both India and China show tremendous economic prospects and increasingly, we are seeing greater interdependence. CPIA reports that India is the largest importer of Chinese pharmaceutical products. Demand from India continues to grow rapidly, up by 61.2 percent in the first three quarters of 2007. Chinese exports to India have exceeded those of the US (which is ranked second) by more than $100 million. To strengthen bilateral exchanges, Reed Sinopharm for example, has held two editions of the Sino-Indian Pharmaceutical Co-operation Forum at API China. Hot topics addressed at the conference included collaborative efforts between the two regions for meeting global API demand, and creating successful business models for foreign exporters. Can you throw some light on the pharmaceutical R&D scenario in China? Can lack of regulatory rules and IPR pose a major problem? The growth of multinationals has helped fuel China's economy and raised the bar for manufacturing quality. The Chinese government has taken active steps to calibrate domestic research and development capabilities with world-class standards. Starting 1, July 2004, China's State Food and Drug Administration (SFDA) imposed a regulation for all pharmaceutical manufacturers to observe Good Manufacturing Practices (GMPs). As a result, companies that could not meet these criteria were eliminated, while reputable large organizations saw their production capacity increase dramatically. In addition, three national laws were passed to protect intellectual property rights in China, and the country has strengthened its legal framework to be consistent with the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). The State Council of the People's Republic of China announced in their 11th Five-Year plans that they will be devoting significant amount of resources into developing frontier technologies, particularly in sectors such as biology and advanced manufacturing technology. By 2020, investments in research and development are expected to be 2.5 percent of the country's GDP. Nayantara Som   ]]> <![CDATA[Dragon or the Tiger?]]> https://biospectrumindia.com/news/95/3485/dragon-or-the-tiger.html https://biospectrumindia.com/news/95/3485/dragon-or-the-tiger.html Tue, 11 Mar 2008 14:30:00 +0530 New Page 1 Dragon or the Tiger? With their phenomenal growth and economic success, India and China are racing to become lucrative pharmaceutical markets for global players Though there was a difference of a decade when their economic transformations took place and despite their different approaches to economic growth, Asian giants, China and India are now standing shoulder-to-shoulder with each other, have identified and cashed on to their strengths and now emerged to become conducive markets for big-wig pharmaceutical MNCs. Much of it arose from economic transformations in the respective nations. While China rose as a powerhouse only after it opened its economy to the world in 1980, economic liberalization ushered into India only after 1990 when the then Finance minister, Dr Manmohan Singh threw away the shackles of the License Raj and opened up the economy to investments and growth. While China cashed on to its state-of-the-art manufacturing facilities and huge reservoir of manpower, India cashed on to its huge amount of investments pouring into the IT and knowledge-based industries and made use of its huge pool of skilled, knowledgeable and English-speaking human resources. A Mckinsey Quarterly clearly mentions, that post 1980, China grew at a lightning speed and pushed forward its GDP growth on the basis of its manufacturing industry. GDP growth had increased to 9 percent in 2003 from 8 percent in 2002. It used its domestic savings to build its infrastructure and attracted foreign investment to build factories and the expertise. The Indian story is all the more phenomenal. On the basis of its world-class knowledge-based industries GDP growth leaped from 4 percent in 2002 to 8.3 in 2003. This had its ripple effects on the pharmaceutical sector. In the pharmaceutical sector, China is big as far as APIs are concerned while Indian companies are cashing on to its service sectors. However, while the world looks at these two Asian countries as cut throat competitors, the strengths of these countries also complement each other and both these countries can work in completion as well as collaboration. They can contribute a lot in changing the market dynamics of the global economy, predict analysts. Market dynamics The differences and common factors together have contributed in placing these nations as the emerging pharma markets. There a lot of commonalities as far as their growth history are concerned. Around one-third of the world's population comes from India and China alone. In China, the figure touched 1,292.27 million at the end of 2003, according to the "Statistical CommuniquÃ© on National Economic and Social Development in 2003" published by the National Bureau of Statistics and reached 1.3 billion in 2006 according to Frost & Sullivan report. The same report states that India, on the other hand touched a figure of 1.095 billion in 2006 up from 1.064 million in 2003. This burgeoning population coupled with a rise in the middle class (along with a rise in disposable income) in both the countries have led to a demand in healthcare facilities and access. Both the countries have witnessed a sharp rise in lifestyle diseases with India becoming the diabetic capital, leading to demand for low-cost and quality products. Both the countries have realised that the solution lay in generic products thus emerging as top generic markets in the world. As far as the total GDP growth is concerned both have witnessed a consistent growth rate of 8 per cent and in the pharmaceutical sector alone they have witnessed a growth rate of 12-13 percent. In addition to this, an increasing cost for research and trials in the west has led to a shift in investments in the east. A KPMG report further states that developing an innovative new drug, from discovery to worldwide marketing, now involves investments of around $1 billion, and the global pharma industry's profitability is under constant attack as costs continue to rise and prices come under pressure. It is primarily for this reason that China and India today have over the years have become the epicenter for outsourcing and R&D activities from big pharma companies. But an important point to bear in mind is that both these nations have churned out not just cheap labour but high skilled technical manpower for which they attracted foreign investments in drones. Domestic pharma market of both nations have been increasing at a rapid pace. The Chinese market in particular, has a strong local market. API manufacturing, DMF and ANDA filings are on the rise here. Both Chinese and Indian companies have had a US and EU API presence. International trade statistics of both these countries show that the US has been their favourite destination for exports. Differences The stark differences in both the markets have culminated in both these nations posing as arch rivals in the pharma market. China has the maximum number of API developments while India's forte has been DMF and ANDA filings (with the exception of Ranbaxy which has a strong API presence). The world today looks at China for low cost APIs plus there have been greater foreign approval for APIs. For instance, Chinese pharma company, Zhejiang Hisun had exported 80 percent of its APIs in 2006. The company also has a strong API presence in statins and anti-cancers. "China is into API because they have a huge manpower base and an excellent manufacturing base," said Shivani Shukla Raval, industry manager, healthcare practice, Frost & Sullivan, South Asia and Middle East. A comparative study revealed that between the year 2003-2005, India had the edge as far as the DMF trends were concerned. In 2003 compared to China, India had a little less than 150 but by 2005 it crossed 250. China's figure was somewhere less than 50 in 2003 and went a little over 50 by 2005. Ranbaxy in 2006 had around 50 ANDA filings; Aurobindo filed approximately 40 in the same year. Increased government role has a major influence in recent developments in both the countries. The Chinese government takes a keen role in deciding on the course that companies should take, the funds and is open to foreign investments. China has a strong manufacturing base today only because the government strongly supports it takes an active role. In India, companies have emerged either because they were family owned or from the sheer spirits of entrepreneurship without much government support. In India, there is an urgent need for Public-Private Investments (PPI). The biotechnology industries in both the countries are coming up in a big way. However, experts opine that China has the edge over India with the Chinese vaccine market bigger than India. China is the largest vaccine manufacturing country in the world today. It attributes its fast growth to the outbreak of SARS in 2003, Avian flu and the spread of Hepatitis B in China. Currently China has more than 30 vaccine manufacturers who have the ability to make 41 vaccines to prevent 26 viral diseases and is producing eight of the world's top ten genetically engineered drugs or vaccines. Chinese companies active in this space include many of those involved in biogenerics such as Sinovac Biotech; Beijing Tiantan Biological Products Co Ltd ; Shenzhen Neptunus Interlong Biotech; and others such as Changchun BCHT Pharma; Anhui Biochem Pharma and Changchun Changsheng Life Sciences. The biotech industry in India is at a very nascent stage and was estimated to be $1.45 billion in 2006. It has registered a growth of 37.42 percent in 2006. The biopharmaceuticals sector in India is valued at just over $1 billion. The biotech industry in India is expected to grow to $5.0 billion in 2010. The industry comprises mainly pure biotechnology companies and big pharma companies who have ventured in biotech. Exports accounted for 51 percent of the total sales of the Indian biotech industry in 2006. India pharma rules the roost with as long as the services is concerned. "We are now outsourcing manufacturing, have become service providers for MNCs and are tying up with them for CRAMS. As a result, profitability of these MNCs has increased with their saving going up their margins so much that they are now setting up manufacturing bases in India. Their thought process is that if the service segment in India is that great why not set up our own manufacturing centers and manufacture products at a cheap cost and the under-utilized segment can be used it for contact manufacture," added Shukla. China on the other hand, needs to improve on the management and services side. China has also taken steps in Intellectual property (IP) rights. Utkarsh Palnitkar, partner, Ernst & Young, elaborated, "China has taken a series of steps in 2006 toward boosting the confidence of foreign multinationals in the country's commitment to IP security, including, establishment of the Judicial Court of Intellectual Property, the stated intent of China's State Intellectual Property Office (SIPO) to complete a National IP strategy by 2007. Again in March 2006, the Chinese government announced the establishment of a new civil court, which will handle piracy on a national level. The judicial court of Intellectual Property, which will operate under the auspices of China's Supreme Court, will hear IP lawsuits filed by local and foreign multinational companies." This has but been a catalyst for MNCs coming into the country. India has a different story to tell. "The industry has turned a new leaf with the adoption of a globally harmonized patent regime in 2005. The domestic industry has evolved substantially and transformed itself from a reverse-engineering led industry; focused on the domestic market, to a research driven, export oriented industry with a global presence," added Palnitkar. While Indian companies have appeared in news headlines for their aggressive foray in regulated markets and emerging economies, the past five years have seen a lull in deals struck by Chinese companies. While China has been facing tougher environmental and regulatory standards within the country, companies here has also been facing difficulties are far as meeting of global regulatory standards are concerned. They need the experience and expertise in this arena. Experts also opine that Chinese companies look into short term, rather than long term profits, which gives India the upper hand. Their inadequate implementation of IP regulations also weakens their relationship with western companies. Collaboration However, both the nations can come together and work in collaboration. Future years will see the US generic markets becoming more competitive leading to lower returns, focus on niche products and consolidation. India and China can work together to meet these demands. Basic research is one area where both the countries can collaborate and work since foreign companies are off shoring their research activities. Human capital has been a strong asset for both the nations. Both the nations have an enormous scientific pool. India tops the list as far as outsourcing is concerned and China is slowly catching up. "China is looking into investing in services and looking at outsourcing opportunity areas. So the gap is slowly being reduced. We have Chinese executives going to English speaking classes and hence globally they now acceptable both in terms of language, skill and culturally," added Shukla. China on the other hand, has benefited from a large number of qualified US and Chinese chemists. A collaboration between the nations can lead to an exchange of knowledge skills and cross exchange of this huge pool of scientists. Generics being the forte for both countries, India and China will bring in a host of low cost generics. With India's strength being formulations and China's being APIs, a collaboration between the nations can gear them up to compete with other nations. Reports also suggest that nexus between both the nations will also see a strengthening in APIs and formulations. Biogenerics is another area where both nations can contribute big time with a number of blockbuster biotech products due to go of patent. China is number one in the area of vaccine development. Today China is the world's largest producer of vaccines. China also has expertise in gene therapy and stem cell research. A system of collaborative R&D between the two countries in these areas will be of mutual benefit. China has established a large number of profit oriented research and development institutions, which are today independent of government funding in contrast to institutions in India, which are mostly dependent on government funding. This is an area where India can collaborate with and learn from China. Also, faced with opposition in many countries, western pharma companies are shifting pre-clinical testing to China in a big way. Animal testing is not a political issue unlike in the US, Europe or India. China is the world's largest supplier of monkeys and canines. Plus India has a booming contract research market. Keeping this in perspective, both the countries can get maximum advantage in clinical trials. India has a strong base as far as marketing their brands and products are concerned, which China can learn. With the focus gradually shifting to these two Asian markets, the coming few decades definitely belongs to India and China in the pharma sector. Nayantara Som   ]]> <![CDATA[The emerging CROs]]> https://biospectrumindia.com/news/95/7931/the-emerging-cros.html https://biospectrumindia.com/news/95/7931/the-emerging-cros.html Tue, 11 Mar 2008 14:20:00 +0530 New Page 1 The emerging CROs The Indian CRO sector registered 70 percent growth in 2006-07 over the previous year's revenues of Rs 425 crore with exports dominating the sector. Datamonitor's R&D Strategies 2007 report points out that the drug developers have become increasingly dependent on CROs, which themselves have become increasingly globalized. This is being driven by both the rise in the number of CROs in emerging markets and the increasing internationalization of western CROs. Most global CROs are present in India or have formed alliances there: seven out of the top 10 CROs have local offices in India with leading companies such as Quintiles, Chiltern, ICON Clinical Research building up a significant India presence. Meanwhile, local CROs are picking up pace, and there is likely to be a period of consolidation in this sector. The Indian CRO sector is growing at nearly 70 percent over the previous year's revenues of Rs 425 crore with exports dominating the sector. There are over 40 companies active in this space. Most of these are actively involved in doing bioavailability/bioequivalence (BA/BE) studies with a handful of them into clinical trials (Phase Iâ€“IV). Considering the potential of doing business in India, many leading CROs of the world who are looking at both India and China as potential markets of investments, are entering India. Given the two countries' low cost base and huge potential patient populations, both the countries are offering services in abundance. Considering the advantages India has and its offerings to the sponsors, McKinsey has estimated that the size of the clinical research market in India will be close to $1.5 billion by 2010. At present the market is just $160 million. As of today, India has witnessed different types of players venturing into the clinical trial data management business, some of them are full fledged CROs starting separate data management units, some of them are IT and ITES companies diversifying to data management business and some are pharmaceutical companies setting up biometrics and data management operations solely on their own or through partnership. Dr Chetan Tamhankar, chief operating officer, SIRO Clinpharm In India there are two aspects -- companies are on the move to develop new molecules and they have been needing services from CRO providers for helping them deliver both within India as well as other geographies. Moreover, there is a lot of pressure now on the supply side of aspects like getting enough CRAs, doctors and putting data management systems in place will be a challenge for the industry for at least the next 3-4 years. India's story is very credible. It may not support on a shorter term a really larger growth - like globalization for instance, if we need to become global players, it is imperative that when we go to a customer, we do our studies in India and other countries and that is also one reason why Indian CROs are expanding to other geographies. To have this global delivery, we at SIRO are trying to emerge as a multinational CRO by extending to non-traditional countries like Central and Eastern Europe and other parts of Asia like Philippine, Singapore, China, Korea, Thailand and Malaysia. To have this global desirability, we need to have seamless operations In fact the main demand for Indian CRO industry is that that it should not be foreign CROs coming to India but Indians on the basis of their credibility going to other countries as a global MNC. That will happen in the near future and SIRO at the moment is targeting countries with Europe from that perspective and in the domestic market we are going to tier 2 and tier 3 cities and tying up with Centers of Excellence (CoEs) for clinical research Nilesh Nayak, senior executive, business and development, Rubicon Research, Mumbai CROs have been the backbone of the Indian biotech industry. The biotech industry is resource-intensive and has a high gestation period for any biotech product to come out. CROs in India have augmented their progress because they have taken off or shared the burden of innovation by providing the requisite infrastructure and with increasing cost, they have also shared the cost with these companies for these trials. CROs in India Cintec International, the global CRO have been successful in entering into a co-development with Dr. Reddy's Laboratories some time back and is also looking in the area of biotechnology particularly developing new cancer drugs. Quintiles in Bangalore is expanding the data management team by moving work to India and has hired 187 people in data management. SIRO Clinpharm has a full fledged data management unit and is also working with Pfizer on a retained FTE model providing contract staffing operations. ICON Clinical Research has acquired a Chennai-based data management company, Biomines Research Solutions which will focus on data management and biometrics services. Mumbai-based Wellquest CRO, the clinical outsourcing division of India pharmaceutical company Nicholas Piramal, opened a 30,000 square foot research facility in Hyderabad and has conducted about 100 pivotal trials and 40 pilot studies. Bangalore based Acunova, an offshoot of Manipal group of hospitals has expertise in bioinformatics and medical software and offers clinical data management and biostatistics services to Pharma companies, besides the site management and contract research capabilities. Synchron, a local CRO offers complete clinical data management services for data processing, analysis and management from their Bangalore facilities. Besides these many clinical trial CROs including Covance, Parexel, Chiltern, PRA International, MDS, Lambda, etc. are exploring the possibility of setting up clinical trial data management and biostatistics in India. IT-biopharma ventures There has also been the involvement of IT companies like Wipro, Intel, Satyam, Cognizant, IBM, Oracle and TCS in their bio-IT initiatives in India. While some of them have actively started the clinical data management initiatives, others are planning to venture into IT solutions. Satyam Computers has recently launched the Satyam LifeSciences Center of Excellence. The LS CoE is a hub for knowledge proliferation, cross leverage of customer experience, domain competence and virtually demonstrable solutions.  In-house IT solutions have been developed in the area of drug accountability, drug counterfeiting, cell line management systems, high throughput analyzers, clinical development, bioinformatics, and sales and marketing solutions in CRM, Key Opinion Leader portals etc. Although there has been a number of local and multinational players in this segment but the ones meeting the industry expectations, with high global standards, regulatory compliances and the pressures of cost and cycle time reductions in drug development, with an efficient data management system will survive.   ]]> <![CDATA[The Year for Pharmerging Markets]]> https://biospectrumindia.com/news/95/2014/the-year-for-pharmerging-markets.html https://biospectrumindia.com/news/95/2014/the-year-for-pharmerging-markets.html Tue, 11 Mar 2008 14:12:00 +0530 New Page 1 The Year for Pharmerging Markets Shailesh Gadre, Managing director, ORG IMS The pharmaceutical sector will witness a shift in growth from the top seven markets to emerging markets. In a year of transition, global pharmaceutical sales will grow 5-6 percent to over $735 billion in 2008, compared to 6-7 percent in 2007, driven by the declining costs of drug treatment in major therapy areas, increased uncertainty over safety, pricing and market access, and intellectual property issues. There will also be a shift in growth from the top seven markets to emerging markets, and from primary care-driven to specialty care-driven drugs. Pharmaceutical players will be required to change their game plan in line with these evolving dynamics in order to stay ahead. This is according to the latest IMS Health Global Pharmaceutical Market and Therapy Forecast. Record low growth for the US In the US and Europe's top five markets, the expected growth in 2008 will be 4-5 percent--an all time low for the US--while Japan will see an even smaller increase of 1-2 percent. Among the factors driving this anticipated performance in these markets are a leveling-off of growth from the introduction of the Medicare Part D prescription drug benefit in the US; patent expiration of branded products, and an associated increase in the use of lower-cost generics; intensified payer pressure to control costs and limited access to certain treatments; and heightened safety scrutiny and healthcare legislation that is slowing, and in some cases halting, the introduction of new medicines. Increased contribution from emerging markets By contrast, the seven "pharmerging" markets of China, Brazil, Mexico, South Korea, India, Turkey and Russia will experience growth of 12-13 percent to reach $85-90 billion, driven by greater access to generic and innovative new medicines, as primary care improves and becomes more available in rural areas, and as more people take private health insurance. For the first time, the seven largest markets will contribute just half of overall pharmaceutical growth, while seven emerging markets will contribute nearly 25 percent of growth worldwide. Generics continue to grow The growth of generic medicines, at 14-15 percent, will be a key market dynamic in 2008 as payers continue to encourage their use through various means, including requirements for pharmacists, substitution check boxes on prescriptions, no-pay and co-pay provisions and budget limits. In Europe, greater use of generics will be driven by new government contracting initiatives in Germany, and educational programs in Spain and Italy. In the US, generics are expected to account for more than two-thirds of all prescriptions written. These factors, combined with loss of market exclusivity for leading products such as Risperdal, Fosamax, Topamax, Lamictal and Depakote, in one or more major markets around the world, will see generics grow to more than $70 billion in 2008. Innovative specialty products on the rise As the impact of established pharmaceuticals losing patent protection accelerates, there will be a decline in the size of the $370-380 billion audited market for primary care-driven drugs. Value growth will be limited to areas of unmet need, with most growth in specialist-driven classes (such as oncology and biotech), that are not as constrained by cost pressures. Overall, the specialist-driven market is forecast to register 14-15 percent growth to record $295-305 billion in revenues. In the coming year, biopharmaceutical and generics companies will more aggressively adjust their business models to manage through these inflections, capturing new opportunities in this challenging market environment. In 2008, up to 29 innovative new medicines will be launched, 80 percent of which will be primarily prescribed by specialists. These include new oncology drugs for treating melanoma and acute myeloid leukemia. Sales of products used in the treatment of oncology are expected to exceed $45 billion in value in 2008, contributing nearly 17 percent of the audited market growth. IMS anticipates an increased willingness by payers and drug manufacturers in this area to enter into "payment for results" arrangements. This comes on the back of an expected rise in the use of evidence to support the value of medicines which will see pharmaceutical companies, governments and other payers implement more sophisticated economic analyses to understand the impact of pharmacotherapies on healthcare budgets worldwide. Greater uncertainty around safety issues Throughout 2008, IMS expects that independent bodies will conduct more meta-analyses of broadly used drugs and that risk will be assessed not only on scientific evidence, but also according to the views of legislators and juries. At this point, the FDA and the European Medicines Agency (EMEA) are both focusing on glitazones, ADHD and erythropoietin. The FDA is also investigating proton pump inhibitors, bisphosphonates for osteoporosis and related disorders, and non-prescription cough and cold medicines. IMS anticipates more limited claims for newly approved medicines, the application of more "black box" warnings on labels, calls for more clinical evidence by regulators, and slower approvals. Overall, this raises the level of uncertainty that companies face in making products available to patients. IP rights challenged on multiple fronts Intellectual property issues under review in 2008 could potentially have significant long-term effects on patent-holders. The issue of compulsory licensing by nations, court rulings on composition of matter and process patents, granting of patents in India, enforcement of intellectual property rights in China, and the reform of patent laws in the US and Europe will all play out to some extent over the course of the following year. Each of these areas adds uncertainty to the fundamental model underpinning the R&D-based pharmaceutical industry.     ]]> <![CDATA[Time to ask "Quo vadis"?]]> https://biospectrumindia.com/news/95/1793/time-to-ask-quo-vadis.html https://biospectrumindia.com/news/95/1793/time-to-ask-quo-vadis.html Tue, 11 Mar 2008 14:07:00 +0530 New Page 1 Time to ask "Quo vadis"? Ranjit Shahani, Vice Chairman & Managing Director, Novartis India Ltd If Indian pharmaceutical companies are distracted with trying to reinvent the wheel, we will lose precious resources that could be focused on incremental innovation. Often seen as an industry that is needed by all but liked by few, if at all, the pharmaceutical industry is going through testing times. It is under growing pressure to keep delivering blockbuster products so as to keep investors happy while at the same time ensure that prices are down. According to sources, $100 billion worth of drugs will be going off patent by 2010. At the same time, clinical development time has doubled since 1982 to an average high of 68 months. With mounting pressure on all fronts, pharmaceutical companies have to rely on their innate skills to deliver products that meet today's medical needs and medical needs of the future while at the same time look at avenues to partner with others so as to deliver newer products at lower costs. With the introduction of product patents in 2005, India took the first big step towards becoming the country of choice for research and development as well as for clinical trials. Both these areas present big opportunities for not just global pharmaceutical companies but also for national pharmaceutical companies out to make a mark for themselves. However, these opportunities will remain on the distant horizon until such time as the patent law continues in its current form and data protection remains a pipe dream. The value of incremental innovation in contributing to medical progress must be recognized. Breakthrough innovations in all fields are few and far between. The invention of the wheel was a breakthrough innovation in transportation. The inventor of the bicycle simply combined two wheels with pedals and gears and revolutionized land travel by eliminating the need for a horse. Steam engines were added to the wheels and gears after their invention, offering an alternative power source for transportation. Once a suitable gas-powered engine was perfected, this innovation replaced the earlier steam engine, creating the first automobile and revolutionizing personal transportation. At no time, in this process of invention did an innovator return to the drawing board to reinvent the wheel. Each used prior research and experimentation as a foundation, building on existing knowledge with additional creative thinking, research and trials. One base technology, the wheel, has been continuously modified to allow transportation to become what it is today. Not recognizing incremental innovation in the pharmaceutical industry is like asking medical researchers to reinvent the wheel. Innovation by steps is essential to pharmaceutical development of new and improved medicines and to public health "Breakthrough" innovations are rare in research and incremental innovation builds on the body of current knowledge, resulting in new, innovative medicines for patients. Currently, it takes 8-10 years to bring a compound from an idea to a usable medicine. During that time span, pharmaceutical companies spend up to $1-1.7 billion researching, developing and testing to create a single drug. If drug discovery was forced back to the beginning each time a new medicine was needed, time and monetary investments would increase exponentially and significantly delay the delivery of medicines to patients. As a global pandemic becomes a reality, biological weapons become a threat, and preventable diseases continue to take lives, we should work to shorten the amount of time it takes to bring a product to market, not unnecessarily lengthen it. From improving a medicine's safety and side effect profile to increasing a country's productivity, incremental innovation provides exceptional value for patients and society. Over 70 percent of medicines on the market today were developed through incremental improvements on a base compound or existing medicine. Given the central role of incremental innovation in medical progress, the value that these types of advancements bring is exceptional. Without these building-block improvements, healthcare would not have progressed to where it is today. Allowing patents for incremental innovations is a crucial way India can improve domestic public health and bring better medicines to Indian patients. An important piece of the research and development process is gathering data on the safety and effectiveness of medications. Protection for research-based organizations' core investment, data, is non-negotiable. Data protection is one of the incentives for companies to bring new and better medicines to market, and is necessary for medicine to progress so as to meet unmet medical needs for today and for the future. Data protection, along with good patent laws, give the research-based pharmaceutical industry the confidence to launch innovative medicines, ensuring patients in India have access to newer therapies. Government's failure to implement these protections will reduce patient access to new medicines--now and in the future. There is an unfounded fear that data protection will lead to higher drug prices. However, experience in other countries that have introduced data protection shows that there is no connection between data protection and drug pricing. Limitations of purchasing power and competition within therapeutic classes keep prices down. Indian pharmaceutical companies are on the cusp of a great opportunity--the opportunity to make a positive change in global health by creating novel medicines through radical and incremental innovation. All we need to do is tap into the wealth of creative and scientific resources at our fingertips. If Indian pharmaceutical companies are distracted with trying to reinvent the wheel, we will lose precious resources that could be focused on incremental innovation--innovation that will bring real value to patients. So let us get on with the job without having to stop to ask the pharmaceutical industry "Quo vadis"? ]]> <![CDATA[Adopting newer diagnostics]]> https://biospectrumindia.com/news/95/1585/adopting-newer-diagnostics.html https://biospectrumindia.com/news/95/1585/adopting-newer-diagnostics.html Tue, 11 Mar 2008 14:06:00 +0530 New Page 1 Adopting newer diagnostics Local diagnostic companies too are launching newer diagnostic products. The Indian diagnostics market is growing at 15-20 percent annually. And newer products are being introduced not only by global players but also by Indian companies. Bangalore-based XCyton Diagnostics has developed the DNA chip for simultaneous identification of 15 different pathogens causing eye infections. Xcytoscreen Keratoconjuctivitus, Uveitis, Retinitis and Endophthalmitis, the specific and sensitive dignostic kits for the detection of 15 microrganisms responsible for infection to both eyes and brain have been developed for the first time in the country and is based on Nucleic Acid Amplification technology and Macro-chip. "About 2,00,000 people suffer from eye infections in India every year and a million globally. The Xcyto-Screen kit has the advantage of being able to detect a series of the eye infecting microorganisms," said Dr Ravikumar, managing director, XCyton Diagnostics, at the product launch event. Navi Mumbai-based Yashraj Biotechnology Ltd (YBL) is one of the few Indian biotech companies focused on molecular diagnostics.YBL uses the proteins purified from human biomedical waste as reagents for the development of indigenous kits. Efforts are on to forge public-private partnership in development of diagnostics on the principles of immunology, DNA detection system, and instrumentation. The focus to develop diagnostics for cancers, acute lower respiratory infection, HIV, diarrhoea, malaria, tuberculosis, and sexually transmitted infections is on the rise. These diseases result in a significant loss of human life. The National Biotechnology Development Strategy of the Department of Biotechnology, Government of India, has talked about the diagnostics for emerging medical paradigm in the sectoral road map and also suggested some strategic actions for the sector. The strategic actions include establishing a cell for diagnostic biotechnology to encourage and support studies in the clinical application of pharmacogenomics. This cell should be well positioned to overcome barriers in its work to bring pharmacogenomics to the clinical setting; encourage research involving investigators with both clinical practice and pharmacology/ pharmacokinetics expertise while at the same time keeping the overall goal of clinical application/utility in focus; provide incentives for this group of clinician-researchers to bring these scientific advances to the patient bedside; support education programs to providers of the importance of this field and its utility; encourage biopharmaceutical companies to include pharmacogenomic data in their drug submissions. Asia outlook With the presence of rich pool of innovation and intellectual property, manufacturing capacity, emerging industry players and maturing market-Asia is beginning to experience the surge in IVD market. At present, Asia Pacific accounts for only two percent of the IVD global sale. Over the past few years, the Asian IVD market has been the only region experiencing close to a double-digit growth rate. While an ageing population and widening health insurance penetration are advancing growth opportunities in this high potential market, divergent country-specific social, economic, political and healthcare issues threaten to impede overall market development. The Kalorama Information report predicts that emerging markets, such as South America and Southeast Asia, where rising standards of living have sparked the growing demands for quality medical care, will experience 10-20 percent annual growth. While Japan, EU, and the US markets, comprising 85 percent of the IVD market, will begin to lose market share, with their portion of the market decreasing to 80 percent by 2010. Asia's ageing population is expected to double by 2025, increasing the number of people likely to require medical treatment. Rising average life expectancies coupled with more affluence are expected to boost expenditure on healthcare treatments, including IVD. For instance, Japan-with the world's third largest aged population-accounts for 90 percent of IVD market revenues in Asia. In other countries, governments are being confronted with the dilemma of reducing healthcare outlays even while expanding healthcare coverage to all. However, the growing realization of their tremendous financial and therapeutic benefits is furthering the popularity of IVD tests. From being under-utilized and undervalued, IVD tests are now increasingly being regarded as key to improving overall cost efficiency and patient outcomes. ]]> <![CDATA["We are niche players"]]> https://biospectrumindia.com/news/95/7502/we-are-niche-players.html https://biospectrumindia.com/news/95/7502/we-are-niche-players.html Tue, 11 Mar 2008 14:03:00 +0530 New Page 1 "We are niche players" -Dhiren Wagle, country manager, Bio-Rad Bio-Rad is a leading player in the diagnostics space with formidable presence in the life sciences and the clinical diagnostics business. While the life sciences sector caters to the academics like universities and government funded research institutes like NII, CCMB and IISc, the clinical diagnostics group basically caters to blood banks, cell pathology labs and stand alone pathology labs that are there in the market. Dhiren Wagle, country manager, Bio-Rad, shares with BioSpectrum the current and future trends in the diagnostics market and how the company is geared to face it. How has the diagnostics market changed in the last 10 years? How has Bio-Rad as a company adapted to the changing market? With the economic liberalization, healthcare has become a priority. With India emerging as a major hub for clinical trials, the labs also have to prove that they are using international standards. So the diagnostics market has been growing steadily at the rate of 15-20 percent. We have products starting from basic products that any lab would require like electrophoresis, ELISA systems. At the same time, we have also introduced new technologies from time to time. In the last 2-3 years, we have come up with products that have helped scientists in biomarker discovery. In biopharmaceuticals also we have products that will help the scientist from protein separation at the lab level to the production level. What are the emerging new areas in life sciences and diagnostics? Life sciences is going to be more of biopharmaceuticals since a lot of investment is going into it. At the same time clinical testing and contract research labs are also being set up. That means a lot of validation and accreditation requirements are also going to come up. New drug discovery is another area where we see the market growing in the next five years. In clinical diagnostics, the focus is now on quality. Though not regulated, the government is taking the right steps. It is putting together a plan for the labs to be accredited along with the National Accreditation Board (NABL). Quality will be the future as far as clinical diagnostics is concerned. What distinguishes Bio Rad from its competitors? We are niche players. We don't play in the run of the mill market like metallurgy analysis where most of the players exist. We have taken a lot of technology from our life sciences group to develop products for our clinical diagnostics division. In diabetes, we do HBa1c, a new way of managing diabetes. We have very little competition in these products. We have quality control products, which help labs manage their quality and also do statistical analysis. We are into genetic screening. The only area where we compete is in infectious diseases testing wherein there are a lot of competitors, but even here we have positioned ourselves in the upper segment. We have introduced a state-of-the-art antigen antibody screening. Typically all the ELISA kits are used for HIV and HCV testing that used to test antibodies. What we are doing now is testing for both antigen and antibodies that reduce the window period. Last year we had a kit for dengue as well. In the life sciences, we have electrophoresis and gene transfer equipment, protein chromatography, and new drug discovery. There are competitors but they are in niche areas like expression proteomics and imaging for instance. They can't give as wide a range as we have. What were some of the new products that Bio-Rad has introduced? We introduced SELDI, which is a tool for biomarker discovery. We also introduced a product for protein interaction called Proteome. These were the two major tools introduced in the lab division. We have some kits coming in for protein extraction. We have kits coming in for protein sample preparation. We have some new standards for measuring the expression of the protein coming in. Can you elaborate on your investments in infrastructure? We have come up with a toll free tech support. All the customer needs to do is call us and we have the trained people to answer the questions on the phone itself. We are in a position to give them the solution on the same day. We have also reorganized our life sciences group in an application oriented way. For example, we have a team of product managers, which specializes in expression proteomics and another on chromatography so that they are experts in their field. Shalini Gupta   ]]> <![CDATA["Roche steps up APAC focus"]]> https://biospectrumindia.com/news/95/2190/roche-steps-up-apac-focus.html https://biospectrumindia.com/news/95/2190/roche-steps-up-apac-focus.html Tue, 11 Mar 2008 13:57:00 +0530 New Page 1 "Roche steps up APAC focus" -Dr Manfred Baier, CEO, Roche Diagnostics Roche Diagnostics, the worldwide No. 1 supplier to diagnostics manufacturers in clinical chemistry, immunology, and molecular diagnostics, has its industrial business organized under Roche Applied Science (RAS). This division has been supplying the diagnostics industry, the life science research industry, and the pharma/ biotech Industry with high quality biochemicals from the last 20 years. Dr Manfred Baier, CEO, Roche Diagnostics, in an interview with BioSpectrum talks about the company's increased focus in the Asia Pacific region. He elaborates on why the company has increased its headcount in APAC by a factor of five, and is currently involved in setting up of dedicated key account managers in the APAC region. Some excerpts: How is the Asia Pacific market shaping up for Roche's products aimed at the research sector and the raw material supplies? For more than 20 years now, the "industrial business" of Roche Applied Science supplies the diagnostics industry, the life science research industry, and the pharma/ biotech industry with high quality bioreagents. Today, APAC is the most emerging market we are working on. Our industrial business grew by more than 20 percent per annum over the last two years, so did research business. In the industrial business one reason for success is that more and more APAC companies are becoming global players or aiming to become one. They are our key customers, because they have to fulfill the highest quality standards and therefore rely on high quality raw materials and customized solutions. Other important customers are Western companies producing in APAC; their number is dynamically growing. Which countries in the Asia Pacific region are emerging as big players in the research areas of pharma and biotech and pure and applied research, which are capable of absorbing Roche products? Most importantly, China and India. A couple of other countries are following. Has the amalgamation process of 454 Life Sciences and NimbleGen been completed? How has this enhanced Roche portfolio of supplier products in the genomics area? The integration of these new members of Roche has been completed last year. In genomics, we are now able to offer complete workflow solutions for all application fields. Genomics, proteomics and now nanotech and nanobiotech are some areas that may see more research investments in the Asian region. What share of this pie Roche is eyeing now? We already have a very good position in genomics and proteomics and should be able to enlarge it further. What are your plans to enhance the presence of Roche in supplying key raw materials to the industry with regional presence? As part of Hoffmann La Roche we know the demands of pharmaceuticals and diagnostics production. This knowledge made us the worldwide No. 1 supplier to diagnostics manufacturers in clinical chemistry, immunology, and molecular diagnostics. Our customers receive the same ingredients that Roche use in our own pharma and diagnostics production. Strictest confidentiality by a dedicated information system is guaranteed. Besides our established product line we offer custom manufacturing and contract production. During the last few years, we have increased our headcount in APAC by factor five, and we are still growing. Currently, we are setting up a team of key account manager for the industrial business in the APAC region. Our investments fulfil our expectations, in the last two years, we experienced tremendous growth rates. Our Penzberg facility near Munich in Germany is one of the world's largest bioengineering and production sites for biochemicals, diagnostics, and pharmaceuticals. Here is where we produce for our own in-house purposes as well as for our commercially operating customers. The multi-purpose plant incorporates state-of-the-art technologies for genetic engineering, fermentation, and downstream processing-a large number and variety of industrial production processes involve over 200 different microorganisms. The facility is licensed to handle recombinant microorganisms that may require a safety stage one license. Where required, products are manufactured to GMP and GLP standards and can satisfy FDA, USDA, and BGA requirements, and the facility is ISO 9001 certified. How soon can one get to see the availability of personalized medicines in Asian countries? How will this translate into a big opportunity for Roche? Personalized medicine will come, and it will come worldwide. The reasons are obvious-treatment has to become more effective, side effects should be minimized, treatment costs have to go down. Roche is the leader in personalized medicine because we have both pharma and diagnostics and know about how to take benefits out of this. Is affordability a key factor for start-up companies and new research-based companies who are in the start-up and early stage of product development? If so, how is Roche preparing to reap the benefits of this growth market with long term potential? Research-based start-ups in APAC face the same global competition as start-ups in other parts of the world and need the same high value skills and tools. To participate in the global research market, the RAS research business has to be always at the edge of technology and provide the most efficient technology to the customers. Are there any issues related to infringement of patents in the industrial and raw material category of products, in the Asian markets? As far as Roche Applied Science is concerned, there are no ongoing issues. Do you visualize the emergence of some of the Asian countries as the new hubs of research in life sciences? Certainly, there is a strong correlation between our research business development in certain APAC countries and development of life science research in these countries. We are strengthening our technology scouting activities in Asia and expect an increasing number of cooperation partners here in future. Do you have any plans to enhance your product and service offering in the region? If so, which are the new products and which markets are you looking at? We will introduce new research products regularly. Regarding the industrial business, we will continue to talk to potential customers, to provide them with high quality reagents according to their specific needs, and to build up long-term relationships. Narayanan Suresh & Ch Srinivas Rao   ]]> <![CDATA[IVD Market Scenario in India]]> https://biospectrumindia.com/news/95/2100/ivd-market-scenario-in-india.html https://biospectrumindia.com/news/95/2100/ivd-market-scenario-in-india.html Tue, 11 Mar 2008 13:38:00 +0530 New Page 1 IVD Market Scenario in India Suresh Vazirani, CMD, Transasia Bio-Medicals Today the total Indian healthcare sector, which is currently valued at $34 billion, is projected to grow to nearly $40 billion by 2012. The diagnostic and pathology market is around 2 percent of the overall healthcare market. The diagnostic market has been growing at 15-20 percent and by all indications shall continue to grow for another 10 years at this rate. At present one major driving force in this respect is the basic demographic change in India, the migration to urban cities, with more and more people having access to modern healthcare. The impetus is provided by the increasing investments in hospitals and clinical laboratories. But this scenario is all set for a change with the medical fraternity looking towards development of the rural sector as well. The IVD market accounts for about 38 percent of the total global medical devices and diagnostic market. The Indian IVD market is estimated to be $330 million as of 2008-09. The IVD market scenario in India has seen substantial developments in the last 4-5 years and these changes shall continue for decades to come. In a very short time, India is poised to catch up with the global IVD market. IVD includes tests which are used either for the analysis of patient body fluids or tissue samples. Tests performed on samples, for example blood, tissues or urine taken from the body are a source of objective information about the body and how it functions. This information is vitally important for clinical decision-making. IVD tests are essential to the practice of health care worldwide. An estimated 60-70 percent of medical decisions involve a diagnostic test. Routine test segments-chemistry/immunoassay, hematology, and routine microbiology-currently make up about 70 percent of the market test-wise. Completely integrated fully automated systems have gained impetus across all segments of the industry for the different types of end users ranging from small labs to multi-specialty hospitals. Utilization of smaller volumes of reagents and samples while simultaneously maintenance of feasibility of testing and quality of results across all product ranges is a must. The IVD market can be divided into the below mentioned segments. The largest slices of the pie include biochemistry and immunology. IVD market in India For the coming year (2008-09), the total market size for clinical chemistry is estimated at Rs 490 crore. Instruments market is estimated at Rs 185 crore while the reagents market is at Rs 305 crore. The reagent market is further divided into closed Systems (Rs 85 crore) and the actual served open market (Rs 220 crore). The leading player in this segment is Transasia Bio-medicals which is ISO 9001:2000 and ISO 13485:2003 certified, has also been rated as India's largest in vitro diagnostics company (2006) by McEvoy & Farmer, USA (International experts on IVD markets). The other major players in this group are Roche Diagnostics, J Mitra, Johnson & Johnson, Beckman Coulter, Trivitron, Accurex, Tulip/Crest, Bayer-Siemens, Agappe, Randox, Span, Wipro Biomed, Merck, Ranbaxy, NPIL-DiaSyS. Apart from these, there are 30 other smaller players operating in this market segment. Emerging technologies in the IVD industry As lab automation continues to evolve, the drive or thrust for smaller, faster, and more-accessible devices is increasing. Emerging markets have different needs with respect to the test menus, technologies used and operating procedures. Thus, made to order solutions need to be developed for these markets. Lab automation has also taken on a new level of importance in the ability to actually get instruments interfaced to various laboratory information systems. Information technology has taken a giant leap in the IVD industry thereby reducing the dependence on a technically qualified individual to be present at all times during the analytical procedure without compromising on established levels of care. Delivering the right data in a timely and cost effective manner while improving the sensitivity and specificity of the test is the need of the hour and the industry needs to gear up for single workstations that can carry multiple workloads. Emerging business opportunity The emerging industry structure is headed towards providing healthcare services as an integrated comprehensive package rather than the traditional concept of providing healthcare infrastructure and reactive medical care. Growing health consciousness among middle and high-income families in India is heralding a new business opportunity -- preventive healthcare. This has shifted focus from in-patient treatment to a regular preventive health check. Corporate companies offer annual health check for their employees; insurance companies conduct pre-insurance policy check; and self paid health checks also give out a potential business opportunity. India as a major bio-industry and IVD manufacturer needs to invest in dedicated research and development to boost the delivery of increasingly sophisticated equipments. Giant steps need to be taken to cross the current chasm to fulfill responsibilities to doctors and patients in meeting and exceeding their needs for reliable, affordable and innovative medical diagnostic systems.   ]]> <![CDATA["We have plenty of opportunities to in-license latest drugs and work on them,"]]> https://biospectrumindia.com/news/95/1681/we-have-plenty-of-opportunities-to-in-license-latest-drugs-and-work-on-them.html https://biospectrumindia.com/news/95/1681/we-have-plenty-of-opportunities-to-in-license-latest-drugs-and-work-on-them.html Tue, 11 Mar 2008 13:34:00 +0530 New Page 1 "We have plenty of opportunities to in-license latest drugs and work on them," Dr Harish Iyer, Head, R&D, Biocon What is state of R&D for oncology in India? My view is that the business models to get these drugs in the market are going to be different in the future. It is a global world now so it is not necessary to spend a lot of money in fundamental research here and come up with all new products yourself. There are a lot of labs around the world working on cancer therapies which cannot manufacture or do the trials or commercialize it. So we have plenty of opportunities to in-license latest drugs and work on them. However, we have to be up-to-date in our knowledge so that we can recognize the value in the opportunities when we see them. Can you tell us something about the features of BIOMAb EGFR? BIOMAb EGFR is a humanized antibody, a complex molecule approximately 150,000 Dalton in molecular weight. It targets a molecule called Epidermal Growth Factor Receptor (EGFR) that is present on epithelial cells. EGFR is present at particularly high levels on tumorous epithelial cells. When the BIOMAb EGFR binds this receptor, it helps to kill the tumor. Our clinical trials have indicated patients respond extremely well to BIOMAb EGFR given in combination with traditional chemotherapy and radiotherapy. These antibodies have complex secondary and tertiary structure that enable them to specifically target cancer cells as opposed to all cells; therefore the systemic toxicity is often very minimal. So you can almost get into a specialist clinic, get an infusion in an outpatient setting and walk away. This is not like typically chemotherapy where you have systemic toxicity because the drug targets specific receptors or signals in the body that cause the disease. We have been working on this product for several years now. It is a novel molecule, which makes it very interesting. In the entire world, there are very few monoclonal antibodies that have been approved, the majority being from the US. Monoclonal antibodies are very complex large molecules, not like aspirin. One needs a lot of scientific expertise to manufacture, characterize and even apply them in a clinical setting. These are not the kind of drugs that you go to the pharmacy and pick up. Typically, they are applied in tertiary care settings where you go to a specialist clinician who then prescribes this drug. We are very fortunate that we have a molecule that got approved in India and is available for the Indian patients ahead of the patients in the rest of the world. This drug is also in clinical trials in Europe. They have very promising results in a very deadly form of brain cancer, called Pontine Glioma, in children. Many other trials are going around the world. There is a global meeting that occurs every once in a while where the investigators meet. Here clinicians came from all over the world, including our clinicians, to share their experience about how this drug has worked. Which are the other companies in this space? There are very few companies in this segment as it is a complex and expensive business. In India, we have Dr Reddy's, and most other companies are global MNCs like Genentech, Roche, Bristol Myers, Amgen, and J&. How successful is BIOMab compared with the existing drugs in the market? I would say it is very successful compared with the conventional treatment. Survival in the BIOMAb along with chemotherapy and radiotherapy is significantly higher than chemotherapy and radiotherapy alone. -Jahanara Parveen ]]> <![CDATA[Anticancer focus on the rise]]> https://biospectrumindia.com/news/95/3380/anticancer-focus-on-the-rise.html https://biospectrumindia.com/news/95/3380/anticancer-focus-on-the-rise.html Tue, 11 Mar 2008 13:28:00 +0530 New Page 1 Anticancer focus on the rise Anti-cancer drugs sales recorded $34.6 billion in sales in 2006 globally with close to 95 products in late-stage trials. In 2006, at least 31 new drug molecules were launched in the world's key markets. Amongst these, some of the prominent releases were in the area of cancer treatment. These include, Gardasil, the first vaccine to prevent cervical cancer and Sutent for renal cancer. Out of the several drugs that were in Phase III clinical trials or are reaching the pre-approval stage, 95 of them are anti-cancer products. Anti-cancer drugs recorded $34.6 billion in sales in 2006. The growth rate was 20.5 percent, which was the highest among the top 10 therapeutic classes. It was fuelled by the demand for innovative anti-cancer therapies. The innovation was at its highest in the oncology segment with over 380 compounds in development. Nearly half the oncology products in late-stage development are targeted therapies. "Targeted therapies have revolutionized the way cancer is being treated-opening up the possibility that many forms of the disease can be fought through long-term maintenance therapy," said Titus Platter, vice president, IMS Oncology. These therapies are helping to win individual battles against cancer, enabling us to think of it as a chronic illness, rather than a life-ending one. With the industry's innovation and ongoing scientific advances, growth in targeted therapies will continue to be very strong and the outcomes even more impressive, he added. Indian Companies With the incidence of cancer cases rising in India, companies have realized the potentialities that this segment has to offer. Bangalore-based Biocon launched BIOMAb EGFR, a therapeutic monoclonal antibody-based drug for treating solid tumors of epithelial origin, such as head and neck cancers, in 2006. The drug is the first of its kind to be clinically developed in India and is the first anti-EGFR humanized monoclonal antibody for cancer to be made available anywhere in the world. This drug is engineered to specifically target and block the epidermal growth factor receptor (EGFR) responsible for the proliferation of cancer cells. "BIOMab EGFR is competitively priced, making cancer treatment more affordable. We aspire to become a key player in this segment," said Biocon chairman and managing director, Kiran Mazumdar-Shaw. The product has shown consistent response in clinical trials initiated both in India and globally and is produced at its manufacturing facility in India. In January 2007, Dabur Pharma launched Nanoxel, a new version of an existing anti-cancer drug Paclitaxel, which is a nanoparticle-based formulation. The new drug can be delivered in higher doses while reducing side effects associated with chemotherapy. The generic anti-cancer drug Paclitaxel is not usually soluble in water or blood, and so must be administered to patients in a castor oil-based solvent called cremophor that itself can cause dangerous side effects. Dabur has a strong focus on developing cancer vaccine, redevelopment of anti-cancer drugs using nanoparticle/nanocell technology, etc. Panacea Biotec forayed into the oncology segment in June 2007 to provide treatment for breast cancer, brain tumor, ovarian cancer, pancreatic cancer, prostrate cancer andcolorectal cancer. For this purpose Oncotrust was established as the new Strategic Business Unit (SBU) of Panacea Biotec with 50 sales specialists. The company aims to garner Rs 15-20 crore in sales from the oncology chemotherapy segment in the next three years. It launched five cancer drugs namely Paclitrust, Docetrust, Gemtrust, Zoletrust, and Temotrust in 2007. It is also expected to launch some novel drug delivery based anti-cancer drug in next 2-3 years. "We plan to develop novel and innovative drug delivery systems (NDDS) of the existing anti-cancer molecule. The new research based drug development will take 2-3 years as we need to develop an effective distribution chain and occupy a significant market share in oncology drugs," said Rajesh Jain, joint managing director, Panacea Biotec. Dr Reddy's Laboratories Ltd in May 2007 launched Redituxa, its brand of rituximab, a monoclonal antibody (MAb) used in the treatment of Non-Hodgkin's Lymphoma (NHL). The company has also launched a social initiative, Sparsh, an assistance program for cancer patients undergoing treatment. The needy patients identified by the doctors through Sparsh would be provided Redituxa free of cost. In an effort to strengthen its oncology business, the Hyderabad-based Dr Reddy's Laboratories has launched its fourth anti-cancer product, named Cantop, a lyophilized form of topotecan hydrochloride. Dr Reddy's currently markets three anti-cancer products -Mitotax (paclitaxel), Dacotin (oxaliplatin), and Docetere (docetaxel). Mitotax is indicated for ovarian and breast cancer after the failure of first line therapy. Dacotin is for colorectal cancer, while Docetere is for lung and breast cancer. Pune-based Serum Institute of India signed a licensing agreement with London-based Lipoxen Technologies in 2005, for a major product development program. The agreement involved eight new product candidates, including protein drugs such as GCSF and EPO, anti-cancer drugs and vaccines. Serum Institute of India would provide the active ingredients and Lipoxen enhanced delivery systems. The agreement combines Lipoxen's strengths in intellectual property and innovation in the drug delivery field. In fact, Serum Institute has started focusing on anti-cancer drugs many of which have gone off patent in the US and Europe. In September 2007, Ranbaxy Laboratories Ltd signed an exclusive in-licensing agreement with Sirtex Medical Pvt Ltd (Sirtex), Australia, to promote and market Sirtex's product, SIR-Spheres. The product, approved by the US Food and Drug Authority, is used for the treatment of patients with inoperable tumors from primary colorectal cancer that have spread to the liver (Unresectable Metastatic Liver Tumors from Primary Colorectal Cancer). SIR-Spheres have been used to treat many hundreds of patients with liver cancer in Australia, New Zealand, Asia, Europe and the US in a variety of clinical trials and general practice. In October 2007, Ranbaxy Laboratories and Zenotech Laboratories Ltd announced the signing of definitive agreement, where by Ranbaxy increased its equity stake to 45 percent from 7 percent. Zenotech has received approvals for sale of three of its products in the oncology and biopharmaceuticals areas. These include GCSF (Granulocyte Colony Stimulating Factor), GM-CSF (Granulocyte Macrophage Colony Stimulating Factor) and IL-2 (Interleukin-2). For the latter two, Zenotech is the first to receive approvals in India, and has a pipeline of further seven biopharmaceutical products in different stages, all developed in-house. It has state-of-the-art manufacturing facilities in Hyderabad, and its R&D facilities are in Hyderabad and New Jersey, USA. Looking the potential of this market, Manipal Acunova, promoted by the Manipal Group, is investing $10 million to position itself as a biotech and clinical research company. In the clinical research space, the company has tie ups with Biocon India, Pfizer, and AstraZeneca for cancer drug trials. As a contract research organization, Manipal Acunova will focus on drug discovery work for the bio-pharma companies using basic biology and chemistry route. Cancer and diabetes are its focused areas. Other players Roche Scientific Company in April 2006 launched its anti-cancer drug Tarceva (erlotinib), which prolongs and improves quality of life of patients, suffering from lung cancer. Tarceva is a novel therapy for patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) after failure of at least one prior chemotherapy regiment. It is an oral tablet taken once a day and had the potential to treat many types of solid tumors In Sep 2006, Merck Specialities, the Indian subsidiary of Merck KGaA, has announced the introduction of ERBITUX, a new gold standard targeted therapy for the treatment of Colorectal Cancer (CRC) in India. ERBITUX works by targeting the Epidermal Growth Factor Receptor (EGFR) which is found on the surface of cells and is involved in the stimulation of cellular growth, replication and/or differentiation when stimulated by growth factors. EGFR has been shown to be involved in the development and progression of many common types of cancers. These are just a few examples of the major happenings in this sector. -Jahanara Parveen   ]]> <![CDATA[Growing M&As]]> https://biospectrumindia.com/news/95/2078/growing-mas.html https://biospectrumindia.com/news/95/2078/growing-mas.html Tue, 11 Mar 2008 13:04:00 +0530 New Page 2 Growing M&As Indian companies are increasingly establishing their presence in the US or European markets via acquisitions and consolidating presence in Asian markets inorganically through mergers or acquisitions. The industry in the past few years has witnessed a lot of action on globalization, alliances and investments. The biotech industry has recorded $1.2 billion (Rs 4,937 crore) revenues in exports. Exports accounted for almost 58 percent of the total revenues generated by the biotech industry. This reiterates the fact that India-based companies have concentrated on going global. Further, global alliances and merger and acquisition (M&A) efforts have taken centerstage. For example, Merieux Alliance has strengthened its presence in Asia by acquiring a majority stake in Shantha Biotechnics, which is focused on vaccines, therapeutic proteins and monoclonal antibodies. Another major development has been the acquisition of Biocon's enzyme business by Novozymes in July 2007. Biocon had sold its enzymes activity to Novozymes, for a total consideration of $115 million (approximately Rs 470 crore). The purchase price has been agreed to $102 million, of which $97 million will be paid upfront, and $5 million when certain business targets have been met. In addition, $13 million is related to committed service fees and lease payments to be paid over a period of up to ten years. Last year RFCL has announced that it has signed a definitive agreement to acquire Wipro BioMed, a leading provider of biomedical solutions. Wipro has reached an understanding with RFCL to transfer its biomed business which includes employees, assets, liabilities, operations, customers and partnerships. The acquisition of Wipro BioMed is a part of RFCL's multi-pronged inorganic growth strategy to emerge as a globally respected company in the field of life sciences solutions. The business operations of Wipro BioMed will be integrated with RFCL's diagnostics division Diagnova. Wipro BioMed has 20 alliance partners in diagnostics, life sciences and medical systems businesses either as an original equipment manufacturer (OEM) or as a distributor. Bangalore-based Avesthagen has also announced its acquisition of 100 percent of the US dietary supplement company, Renaissance Herbs Inc. (RHI). RHI is a fully integrated supplier of proprietary nutritional products that are marketed on a global basis through multiple sales channels. The company sources its raw materials in India and South East Asia for processing in its facilities outside of Bangalore. The acquisition supports Avesthagen's bio-nutritional business strategy through vertical integration and access to key markets. Panacea Biotec, the second largest vaccine producer of India, signed an agreement with PT Bio Farma, Indonesia, to manufacture and market the measles vaccine. As per the terms of agreement, Panacea Biotec will procure the bulk vaccine from PT Bio Farma and formulate it into a finished product. This collaboration will help boost Panacea Biotec's revenues and profits besides widening the product range. Reliance Life Sciences (RLS), a flagship company of Mukesh Ambani's Reliance Group, will invest to the tune of Rs 279 crore in GeneMedix, a UK-based biopharmaceutical company, to take the latter's biosimilars through to launch in the EU and the US. Following the trend, Serum Institute of India, the largest manufacturer of vaccines in India, also picked up a 14 percent stake in the UK-based Lipoxen, a biopharmaceutical company specializing in the development of differentiated biologicals, vaccines and oncology drugs. Lipoxen has raised £2.6 million in new funds from the Serum Institute of India through a subscription agreement and associated warrant agreement. Serum also entered into an agreement with Akorn of the US for definitive development and exclusive distribution rights for rabies monoclonal antibody. As part of the agreement, Serum has agreed to appoint Akorn as the exclusive distributor for rabies monoclonal antibody. In exchange for Akorn receiving the exclusive marketing and distribution rights to North, Central, and South America, Akorn has agreed to help fund product development through milestone payments. Biocon's Syngene entered into a research partnership with Bristol-Myers Squibb to provide R&D services for discovery and early drug development. Bristol-Myers Squibb will also increase the scope of its existing relationship with Syngene to further develop integrated capabilities in India in medicinal chemistry, biology, drug metabolism, and pharmaceutical development. Recently Biocon also announced that it has reached an agreement to acquire a 70 percent stake in German pharmaceutical company, AxiCorp GmbH for a consideration of â‚¬30 million. This will enable the marketing and distribution of a range of pharmaceutical products in Germany and Europe. Wockhardt has signed an in-licensing agreement with US-based Advanced Biotechnologies to market Kelocote, a patent protected product to treat scars. Alembic, a pharmaceutical major in India, has entered into a licensing agreement with Brussels-based UCB for its novel drug delivery platform, Keppra XR (Levetiracetam Extended Release Tablets). UCB is a leading global biopharmaceutical company in the area of central nervous system (CNS) disorders, respiratory diseases, immune and inflammatory disorders and oncology. Intas Biopharmaceuticals has entered into a strategic R&D agreement with the US-based Virionics Corporation for development of Human Papilloma Virus (HPV-16 & HPV-18) therapeutic vaccine, useful for treatment of cervical cancer. It has also signed a MoU with Viropro Inc. to jointly explore the possibilities of production of an undisclosed molecule. Intas Biopharmaceutcials has also entered into a joint venture with Progenetics LLC, a US-based company that has created transgenic animals producing Factor-IX (a drug used for treatment of Hemophilia-B), in milk. As per the agreement, Intas Biopharmaceuticals would develop drugs from such transgenic animals, carry out clinical trials and launch the drugs in India and in overseas markets. Nicholas Piramal India Ltd (NPIL) and Eli Lilly and Company have signed a landmark new drug development agreement to develop and, in certain regions, commercialize a select group of Lilly's clinical drug candidates that span multiple therapeutic areas. The NPIL-Lilly alliance seeks to increase productivity in drug development by synergizing the unique strengths of both companies and equitably sharing risk and reward. Avestha Biotherapeutic and Research Pvt Ltd (ABRPL), a joint venture between Avesthagen and Meditab Specialities Ltd of Cipla group, signed an MoU with Malaysian Biotechnology Corporation to enhance the infrastructure needs with an objective to accelerate its 11 biosimilar product development programs. This is just a partial list of alliances. The trend in the industry is clearly to consolidate core businesses and grow and one is likely to see more deals during the year. Tracking India pharma deals India is a key outsourcing destination for global pharma companies. Indian contract manufacturing and contract/clinical research organizations are expanding capacities and building capabilities through greenfield expansions or mergers and acquisitions, or both, to cater to the increased CRAMS business coming to India. Similarly, even integrated Indian pharma companies with global aspirations are expanding geographical reach and R&D strengths through the organic as well as inorganic growth route to make their mark in the global market. Here is a roundup of pharma deals by Indian players for the period of November 2007 to January 2008. M&As Among the drivers for consolidation in the Indian pharma industry are, gaining proximity to clients, developing a niche in a therapeutic area, accessing technologies and expanding geographic presence with the objective of providing a one-stop-shop to clients. Key M&A deals during the period November 2007-January 2008 include Manipal AcuNova's acquisition of German Ecron. This acquisition will enable Manipal to provide services in phase I-IV clinical trials. Acquirer Target Deal Size and Date Arch Pharmalabs Avon Organics (Hyderabad, India) Not disclosed yet/ Nov-07 Manipal AcuNova Ecron (Frankfurt, Germany) Undisclosed, Nov-07 Plethico Pharmaceuticals Natrol Inc (California, US) $80 million, Nov-07 Reckitt Benckiser Adams Respiratory (Chester New Jersey, US) $2.3 billion, Dec-07 Biocon Syngene (Bangalore, India) Jan-08 Nicholas Piramal Healthline Pvt. Ltd (HLPL) (Bangalore, India) $3.8 million/ Jan-08 IPCA Laboratories Tonira Pharma (Gujarat, India) Jan-08 Expansions Players are expanding capacities to cater to the increasing number of contract deals coming to India. Key expansions during the period November 2007 to January 2008 include the $50.5 million investment by Advinus Therapeutics to set up a new development center and corporate office in Bangalore. Shasun is setting up a process development facility in North America to cater to its clients there. Company Location Date Details Ajanta Pharma to upgrade its manufacturing and R&D facilities Ajanta Pharma Paithan, Maharashtra, India Nov-07 Ajanta Pharma is investing $8.8 million in expanding its manufacturing facility and $6.3 million in upgrading its R&D facility. After the planned expansion, the tablet manufacturing capacity will increase from six million in a single shift to 13 million. Actis Biologics to set up new manufacturing facility in Mumbai Actis Biologics Mumbai, Maharashtra, India Nov-07 Actis Biologics is investing $4-5 million for setting up a new manufacturing unit, which is expected to get completed in one year. The new manufacturing facility will work towards medical device, diagnostic, gene therapy and protein therapy. Plethico to upgrade its two facilities Plethico Pharmaceuticals Indore, Madhya Pradesh, India An investment of $2.5 million will be made to upgrade its two facilities to be in accordance to the US FDA norms. Advinus opens a new development center Advinus Therapeutics Bangalore, Karnataka, India Nov-07 An investment of $50.5 million is made to build up a new corporate office and a development center. The facility is spread over an area of eight acres and has 210,000 sft of built-up area. The facility will provide pre-clinical development capabilities including agro chemical development. Sanofi-Aventis to set up pharmaceutical development center Sanofi-Aventis Goa, India Dec-07 The development center will provide facility for development of pharmaceutical and analytical formulation and will be spread over an area of 2600 sqm. It will have the capacity to develop up to 12 pharmaceutical compounds each year. Bilcare to set up clinical research facility in Wales Bilcare South Wales, United Kingdom Dec-07 Bilcare will invest $22.6 million in setting up a clinical research facility in South Wales. This investment will enable Bilcare to expand its presence in Wales. Veeda CR to set up new clinical research facility Veeda CR Ahmedabad, Gujarat, India Dec-07 An investment of $25.2 million will be made towards setting up of new clinical research facility. Company is looking for three more locations to expand its research activities Medicamen Biotech to set up a second unit Medicamen Biotech Uttaranchal, India Dec-07 The company is setting up its second unit and is looking out for a partner to market its products in the domestic market. Siro Clinpharm to expand overseas Siro Clinpharm Mumbai, Maharashtra, India Dec-07 An investment of $25.3 million will be made for setting up its new oncology API manufacturing facility and R&D center. The company has 21 acres of land in Raichur Industrial Growth Center and plans to start commercial operations by mid 2008. Venus Remedies sets up new R&D centre at Baddi Venus Remedies Baddi, Solan District, Himachal Pradesh, India Jan-08 The company is at the last stage of expansion of its $63.4 million R&D facility spread over 40,000 sft. It will have a team of 50 people including 25 scientists and other R&D staff. The R&D center has seven pilot plants for trial production of injections in super specialty segments and eight labs for testing in-house. Shasun Chemicals to set up a development facility Shasun Chemicals & Drugs Piscataway, New Jersey, USA Jan-08 The company is setting up a process development unit to provide development services in Active Pharmaceutical Ingredients directly in North America. The facility will provide services in the pre-clinical and clinical stages and will also provide backend services to Shasun's CRAM service partners in North America. Growing M&As New Page 3 CRAMS Deals Deals involving sharing of intellectual property and licensing of technologies are increasing in number with not only large global companies, but even mid-sized companies resorting to outsourcing. However, these deals are smaller in size. Key deals during November 2007 to January 2008 period, include the contract research deals between Nicholas Piramal and Merck, and Jubilant Biosys and Forest Laboratories. Primary Company Deal Partner Deal Date Deal Details Ajanta Pharma Arrow Pharma (Canada) Nov-07 Agreement to market Nimesulide in Brazil Nicholas Piramal Merck (New Jersey, US) Nov-07 R&D deal for new drugs for two selected categories. Nicholas Piramal will be responsible for developing, pre-clinical trials, clinical trials phase I and II. It will receive milestone payment of $175 million per target and also royalty payment on sale. of any of these developed products. Strides Arcolab Aspen Pharmacare (Durban, South Africa) Nov-07 Both the companies have entered into four transactions: A 50% joint venture to develop, manufacture and commercialize on a global basis a range of oncology products. Strides' acquisition of a 51% interest in Aspen's UK based subsidiary Co-pharma Limited. Strides' acquisition of 80% interest in Formula Naturelle (Pty) Ltd which will, in turn own a group of nutraceutical products currently marketed by Aspen Aspen's acquisition of 50% interest in Strides Latin American operations Dr. Reddy's Laboratories Sygnis Pharma AG (Heidelberg, Germany) Nov-07 Agreement to supply Active Pharmaceutical Ingredient AX200 to Sygnis for developing treatment of neurodegenerative disorders.The agreement also includes marketing of AX200. Jubilant Biosys Forest Laboratories (New York, US) Dec-07 Agreement to discover small molecule drug candidates for a novel metabolic disorder target. Jubilant Biosys will be responsible for drug discovery work and Forest Lab for pro-clinical development. Forest Lab will own the drug discovered and will have worldwide commercialization rights. Strides Arcolab Sagent Pharmaceuticals (Illinois, US) Dec-07 Both the companies have entered into an agreement to develop, market and supply injectable products in US.The agreement will initially cover 25 products. As per the agreement, Strides will develop and supply the injectable products, which Sagent will market in the US. Biocon IATRICa (based in Baltimore, Maryland, US) Jan-08 The two companies have entered into a partnership to co-develop immunoconjugates for targeted immunotherapy of cancers and infectious diseases. Both the companies will co-develop products based on IATRICa's technology and Biocon's expertise in clinical research, drug discovery and biologics manufacturing. Cadila Healthcare Prolong Pharmaceuticals Inc., (New Jersey, US) Jan-08 The two companies have entered into a collaboration to develop PEG-EPO, a therapeutic protein for the treatment of anemia. ]]> <![CDATA[Global biotech industry is on mission transformation]]> https://biospectrumindia.com/news/95/5649/global-biotech-industry-is-on-mission-transformation.html https://biospectrumindia.com/news/95/5649/global-biotech-industry-is-on-mission-transformation.html Tue, 11 Mar 2008 12:45:00 +0530 New Page 1 India presence of global biosuppliers increases The biosuppliers industry is witnessing a 30 percent growth every year In the last few years, Asia, and more so India, is a high growth market for the global life science suppliers. Almost all the global majors like Agilent Technologies, Bio-Rad, GE Healthcare, Invitrogen, Millipore, Pall, Perkin Elmer, Shimadzu, Thermo Electron, and Waters Corporation have strengthened their presence and market hold in India. These global majors are consolidating their presence in India, adding on their own sales representatives as well as distributors, besides executing a number of other initiatives like setting up various Centers of Excellence (CoEs). Today, for several of the global vendors, the Asia-Pacific region accounts for almost 15-20 percent of their world-wide sales revenues, and their India business contributes almost 8-10 percent of the Asia-Pacific sales. For example, 16 percent of Millipore's total 2006 global business of $1.2 billion was generated in Asia. The life sciences business of Pall Corporation represents about 40 percent of its global sales of $2.01 billion in 2006 and Asia accounts for 14 percent share of its total life science business of $796.3 million. Bio-Rad's pacific rim sales accounted for 16 percent share of the total business of $1.27 billion in 2006. Dr Kreuzburg, CEO of Sartorius Stedim Biotech, said, "The business in India is growing at a fast rate, making it very appealing. It is certainly appealing for Stedim, which plans to open a new campus in Bangalore by mid 2008." These global companies are consolidating their presence in India for two prime reasons. One, India is a very attractive and growing market. The other reason is to leverage the skilled manpower in India. Regulatory changes in testing and the growing bioscience and life sciences industry have been some of the major drivers for the growth of the biosuppliers. The demand for all the products-separation, instrumentation, mass spectrometry, surface sciences, lab automation, or general lab equipment-is on the rise. And the demand is coming from the generic drug manufacturers and contract research organizations. "With all the opportunities prevalent in India, there can be no doubt that India is positioned to become a global player in the biotech Industry by the year 2010. India has built a strong market with the growth of biopharmaceutical companies, CROs and biogenerics" said Gregory Summe, chairman and CEO, PerkinElmer. The Indian biotech industry in 2006-07 surpassed $2 billion revenues in 2006-07, registering 31 percent growth. And the biosuppliers business too followed the same path of growth of the biotech industry to register total revenues of Rs 2,420 crore ($590 million) in 2006-07, compared to the previous year's revised estimates of Rs 1,831 crore ($407 million). Thermo Electron was the leading life sciences supplier in the country with sales of Rs 246 crore. The top three companies of this year's survey--Thermo Electron, Labindia Instruments, and Waters India--have crossed the $50 million (Rs 200 crore) mark. Interestingly, the Top 10 companies this year have revenues in excess of $25 million (Rs 100 crore). In 2005-06, only seven companies were able to do $25 million in sales, and none had reached the $50 million figure. Further, Indian grown companies, which represent several global principals in India, have scaled themselves from being a distributor to offering quality services and solutions. This is one of the reason why we see almost eight Indian companies in the Top 20 BioSuppliers list and the top five Indian companies-Labindia, Spinco Biotech, HiMedia Laboratories, DSS Imagetech, and Genetix Biotech Asia-accounted for close to 26 percent share of the total market of Rs 2,420 crore. Today, almost 85 percent of the total biotech suppliers business is generated by the Top 20 biotech suppliers. According to Art Caputo, president, Waters Division, Waters Corp., "India has built a strong market with the growth of biopharmaceutical companies and food safety and environmental concerns are few of the upcoming trends." Another important aspect of this business is that no single region accounts for a majority share of the business generated by companies headquartered in that region. This is clearly representative of the fact that the biotech industry is scattered across the country. The industry hopes to register 30 percent growth in 2007-08 too. Global biotechs transform The global biotech industry is predicted to touch $100 billion by 2010. According to G Steven Burrill, CEO, Burrill & Company, a San Francisco-based global company, in life sciences whose principal activities are in venture capital, merchant banking and media, the global biotech industry is "transforming". The industry is moving away from chemistry to biochemistry; from one size fits all drugs to personalized medicine; from aging (just happens) to aging is optional; therapeutics, diagnostics, and devices becoming "theranostics"; the focus is shifting from treating sickness to preventing sickness; and it's no more food for survival, but food for health. According to Ernst & Young's 2007 Global Biotechnology Report, the biotech industry made historic progress with strong product pipelines and product successes, record-breaking financing totals, unprecedented deal activity and impressive financial results. The global biotech revenues of the public listed companies in 2006 grew to $73.5 billion recording a 14 percent growth over that in 2005 ($64 billion). Further, according to the report, all the leading regions in the world recorded a strong double digit growth, with the US and Europe recording 13 percent growth each and Canada registering 22 percent growth. "The industry in the US has never been stronger and we're seeing its success story spreading to other parts of the world-particularly Europe," said Glen Giovannetti, Ernst & Young's Global Biotechnology Leader. "Time will determine whether these trends will be sustained, but there's reason for optimism. Innovation is being rewarded with record revenues and unprecedented premiums in M&A transactions." "The industry is over 30 years old and is generating over $85 billion in revenues. There are 5,000 companies worldwide, 600 of which are public companies. The life sciences sector has a strong performance record, even in difficult economic and political times and has outperformed Dow and NASDAQ. There are over 100 products on the market (many of them are $1 billion drugs). Further, 350 biotech drugs are in late stage clinical trials (strong pipeline). Agbio products are now grown on 200 million acres world wide and it is growing at 20 percent per year. The market cap is going in the right direction with the figure touching $550 billion," said Burrill. The global transformation is underway not just in technology but also in the industry. With over 5,000 companies, biotech is a global industry now. According to Burrill even the smallest biotech is a global player from Day One. "The global transformation that is a central theme in our book, Biotech 2007, does not just refer to geography. It is occurring pan-industry and across technology and having an impact on the innovation that results," observed Burrill. "We have begun to understand disease 'globally' i.e., from a systems point of view, from gene or SNP to protein to networks to disease. In parallel, and conversely, the notion of 'one size fits all' is being replaced by medicine targeting the individual and the central tenet on which a huge biopharmaceutical industry has been built has to adjust to a new and evolving personalized medicine world." In fact, the global biotechnology industry showed robust growth in all respects in 2006 according to Ernst & Young report. Deal values soared with alliances involving US companies totaling $23 billion-an all-time record-while high premiums (the difference between the price per share paid by a buyer and the company's share price before the deal was announced) drove the value of mergers and acquisitions (M&A) to the second-highest level in the industry's history. Capital raised by the world's biotechnology companies grew by a massive 42 percent, to $27.9 billion. Venture capital (VC) reached $5.4 billion, an all-time high. Net losses of publicly traded companies fell by 37 percent in Europe and 43 percent in Canada, creating momentum toward profitability. While the US sector saw increased net losses, this was primarily due to large transaction-related charges in a year of unprecedented deal activity; in the absence of these, the US industry would have been profitable in aggregate for the first time, and the global industry would have had its lowest net-loss ever. The US product approvals increased from 33 in 2005 to 36 in 2006. New drug application (NDA) and biologic license application (BLA) approvals grew from 21 to 25. In Europe, product pipelines of public companies grew significantly. The US The US. had another strong year for product approvals with 36, including 25 NDAs and BLAs in 2006. This compares favorably with 2005, when the industry secured 33 approvals, including 21 NDAs and BLAs. Capital raised increased by 38 percent, fueled by some of the largest financings in industry history. The US revenue grew by 13 percent among public and private biotech companies to $59 billion, and the industry made a truly historic move toward profitability. In the absence of over $4 billion in acquired in-process R&D charges related to the year's unprecedented deal activity, the US publicly-traded sector would have shown an aggregate net profit, for the first time in its history. Notably, the largest revenue growth companies in the US included "mid-tier" firms with recent product launches and rapidly growing sales. "We predicted profitability in the US industry before the end of the decade," said Mike Hildreth, Americas Biotechnology Leader, Ernst & Young. "Only a strong deal year with high charges for in-process research and development kept the industry from reaching that goal this year." Europe The European biotech sector sustained the recovery it had begun in 2005, with revenue growth of 13 percent-more then twice the 2005 growth rate of six percent-contributing to revenues (for public and private biotech companies) of $16.6 billion. The year 2006 marks a four-year turnaround, from the 12 percent revenue decline recorded in 2003. Financing increased by a robust 45 percent to reach $5.9 billion. VC financings reached an all-time high of $1.9 billion. The pipelines of publicly traded companies grew an impressive 30 percent, bringing the overall pipeline to almost 700 compounds, plus 27 in registration and awaiting regulatory approval. In addition, Europe's privately held biotechs have nearly 800 compounds in their pipelines, and 12 compounds in registration. "There was cautious optimism in the European biotech industry-as the sector emerged from a prolonged period of restructuring in 2006," said Siegfried Bialojan, Germany Biotechnology Leader, Ernst & Young. "This year double-digit revenue growth and sustained success across multiple measures prove Europe's biotech sector has bounced back." Asia-Pacific In Asia-Pacific, governments and companies are moving aggressively to make the transition from competing on cost to developing homegrown innovative pipelines. Businesses are adopting creative models to overcome capital constraints and other hurdles. Firms are reinvesting revenues from services to develop innovative pipelines, and are entering deals to accelerate commercialization efforts, drive economies of scale and increase global competitiveness. Conglomerates are entering the fray, making investments in the growing sector. "Asian biotechnology companies face critical challenges in their efforts to accelerate the transition to become enterprises driven by research and development," said Utkarsh Palnitkar, India Biotechnology Leader, Ernst & Young. "Companies are leveraging the Asian advantage in bio-manufacturing and contract services arena and utilizing them to drive the growth story in drug discovery and research." Coming to the predictions for 2008, Burrill pointed out that there would be heated debate on the healthcare. Further sales of products will continue to increase. The industry will continue to live in the world of stricter regulations, but the products will come. The big pharma and big biotechs will fight to accelerate products. While newer business models will continue to evolve, 30 IPOs were expected during 2007. And geographic clusters will be less important as clusters will be as per diseases.     ]]> <![CDATA[Dr Reddy's aims to be a Biosimilar leader]]> https://biospectrumindia.com/news/95/6260/dr-reddys-aims-to-be-a-biosimilar-leader.html https://biospectrumindia.com/news/95/6260/dr-reddys-aims-to-be-a-biosimilar-leader.html Tue, 11 Mar 2008 12:44:00 +0530 New Page 1 Dr Reddy's aims to be a Biosimilar leader GV Prasad, vice chairman and CEO, DRL with Satish Reddy, COO, DRL Hyderabad-based, Dr Reddy's Laboratories, the $1.2 billion Indian pharma major, and one of the world's leading generics players, is making determined efforts to increase its portfolio of biosimilar products and become a global leader in the next decade in this space. A special report from the company's Hyderabad campus. After conquering the pharma generics space, as one of the world's Top 10 players, Dr Reddy's Laboratories (DRL), has turned its attention to repeat the success story in the biologicals arena. "We want to be the world's No.1 biosimilar company. And we would like to introduce one new product every year and we are looking at a portfolio of 15 to 20 products," summed up DRL's Vice Chairman and CEO, GV Prasad, while interacting with a select group of journalists at the company's corporate headquarters in Hyderabad recently. It is a tough task but the company is going ahead with its customary zeal to enhance its presence in the biotech arena. A biotech expert, Cartikeya Reddy, Vice President, is spearheading the biologicals thrust with a scientific team exceeding 100 members and new facilities and capacity expansions are going on at a furious pace in the company's manufacturing complex on the outskirts of Hyderabad. The company has invested over $30 million in its biologicals facility so far. DRL has so far launched two biological products, Grafeel (a Filigrastim) and Reditux (biosimilar version of Rituximab) which is the world's first monoclonal anti-body based anti-cancer drug. Prasad is aware of the challenges in the biosimilar area, where the regulatory rules in the two most important markets of the world--US and Europe--are not yet clear. "It is a big game. It will cost at least $20 million to take a biosimilar drug to the European market. It takes only a small fraction of that amount for a conventional generics pharma product," Prasad explained. The company is looking at introducing these products in the European markets in the next three-four years, buoyed by the guidelines on biosimilars announced by the regulatory agency there. DRL is planning to generate clinical trial data in Europe soon. DRL is planning to increase its portfolio of biosimilars. It is eyeing some of the eight biotech drugs which have not been patented in India. Focus areas At the strategy level, DRL is increasing its focus on innovation and has identified four major areas. Its drug discovery and research efforts, Prasad said, are concentrated in oncology, metabolic disorders such as diabetes, cardiovascular diseases and infectious diseases. Prasad said the company will redouble the efforts to meet its mission to provide affordable healthcare through alternatives to expensive, branded pharma products. Innovation to meet the unmet medical needs will be the thrust area for the company. DRL's COO Satish Reddy said the company was trying its best to increase its presence in new geographies. Market exploration was going on in Japan and its presence may be increased in the Australian and New Zealand markets. The company is also increasing its focus on Mexico and many tender-based markets. "If you want to be a global generics player, you have to take these chances," Reddy said. DRL has got the approval to set up a 250-acre Special Economic Zone focused on pharma products in Hyderabad. The SEZ will specialize in the manufacture of bulk drugs and formulations. DRL has been elated by the recent visit of the US Health Minister (Secretary for Health and Human Services), Michael Levitt, and inspection of its manufacturing facilities in Hyderabad. DRL has one of the largest Active Pharmaceutical Ingredient (API) manufacturing facilities in the Asia-Pacific region. By N Suresh in Hyderabad   ]]> <![CDATA[Indian biotech industry matures]]> https://biospectrumindia.com/news/95/2193/indian-biotech-industry-matures.html https://biospectrumindia.com/news/95/2193/indian-biotech-industry-matures.html Tue, 11 Mar 2008 12:40:00 +0530 New Page 1 Indian biotech industry matures BioSpectrum and ABLE have been tracking the biotech industry in India for the last five years. The industry has clearly matured and a new breed of entrepreneurs too has come up. The biotech industry in 2006-07 crossed the $2 billion (Rs 8,541 core) mark. Exports alone were in excess of $1.2 billion. The industry has recorded a CAGR of 30 percent during FY 2002-2007. And at that rate the industry in FY 2015-16 is predicted to touch Rs 30000 crore ($8 billion) in revenues. In the last two years, there has been a lot of action in the industry. The trend is towards globalization, alliances, investments, and product launches. The biotech industry in India, comprising of five distinct segments--biopharma, bioagriculture, bioinformatics, bioindustrial and bioservices-has over 350 companies now. Nearly 40 percent of the companies operate in the biopharma sector, followed by the bioservices (21 percent), the bioagri (19 percent), bioinformatics (14 percent) and lastly the bioindustrial sector (5 percent). The industry has been sustaining a 30 percent growth continuously for the last five years. Though one can argue that the base is small, the industry is confidant that it would continue to grow at this rate for the next five years. All this has happened when the investments were not forthcoming, there was no policy support, and there was lack of clarity on the regulatory issues. However, with the new National Biotech Development Strategy in place and with the government focusing on encouraging R&D and innovation, things are expected to change for the better. The biopharma segment is the largest contributor to the industry figures. It accounts for over two-thirds of the industry. This segment alone recorded sales in excess of $1.45 billion (Rs 5,973 crore and also continues to register a growth in excess of 25 percent. Exports account for over 55 percent share of the total biotech revenues. The biopharma sector generated over 60 percent of its revenues through exports, while the bioservices contributed to a fifth of the exports (Rs 1,102 crore). The bioservices sector registered 53 percent growth. The bioagri sector too continues to boom. It is closer to the Rs 1000 crore mark now. The three top companies Rasi Seeds, Nuziveedu Seeds, and Mahyco Monsanto account for 80 percent share of this market. The bioindustrial has crossed Rs 400 crore in sales. The investments (both in R&D and infrastructure) in the biotech industry has risen at a CAGR of 29 percent in the last five years and touched Rs 2,270 crore in 2006-07 (close to $500 million). The biotech industry employs over 20,000 scientists and is concentrated in six major clusters in Bangalore, Hyderabad, Chennai, Pune-Mumbai, Delhi and Ahmedabad-Vadodara. Based on the current trends, the industry is estimated to have over 400 companies by 2010, of which nearly 10-15 biotech companies will go public, with about 100 biotech (domestic and imported) products in the market and have 50,000 scientists working in the biotech labs. Another important aspect of the Indian biotech industry is that the Top 30 home grown companies account for $1.05 billion in revenues. This is a good sign as the industry is on the path to become larger. Three home grown companies--Serum, Biocon, and Panacea--have crossed the Rs 500 crore mark and are close to the Rs 1,000 crore mark. The top 30 home grown companies have a healthy mix of pharma and bioagri. In fact, Venkateshwara Hatcheries and Indian Immunologicals are two of the leading players in the poultry and animal health care area respectively. The list also contains industrial biotech companies, Advanced Enzyme Technologies and Rossari Biotech. While the biopharma, including animal health care companies, and bioagri companies, have crossed the Rs 100 crore mark, the bioindustrial and bioindustrial companies will also breach this figure soon.   ]]> <![CDATA[DBT team taps industry for project plans]]> https://biospectrumindia.com/news/95/1502/dbt-team-taps-industry-for-project-plans.html https://biospectrumindia.com/news/95/1502/dbt-team-taps-industry-for-project-plans.html Tue, 11 Mar 2008 12:24:00 +0530 New Page 1 Implementing NBDS It was in the March 2003 inaugural issue of BioSpectrum that the need to formulate a national biotech policy was highlighted. Dr MK Bhan, secretary, DBT, and the union minister for science and technology, Kapil Sibal, who took charge in 2004, recognized the importance of biotechnology in India and took the onus of developing an industry-friendly policy. On October 21, 2004, when Sibal met biotech CEOs in Bangalore, who came together under the Association of Biotechnology-Led Entrepreneurs (ABLE), he said that a national biotech policy would be in place by January 2005 that would comply with the global regime on intellectual property rights and be a quadrilateral agreement between the academia, industry, laboratories and the state, addressing the procedural issues. Though, the Indian government approved the National Biotech Policy (National Biotechnology Development Strategy) in late 2007, the streamlining of various regulatory issues started much before. Policy highlights BIPP (Biotechnology Industry Partnership Program) Fuelling innovation and entering new territories to build IPR The program caters the need to generate IPR in advanced technology areas. Early product development is not expected in these areas because these will be radically new fields like stem cell therapy and nanoscience. "The idea is to enter the advanced technology area when its potential is uncertain rather than when the potential is established'" explained Dr Bhan. BIRAC Funding innovation Promotion of R&D is another priority under the strategy for which the government is investing in a new organization, BIRAC. According to Dr Bhan, "The Biotechnology Industry Research Assistance council (BIRAC) will manage SBIRI and BIPP. In addition to that it will provide patenting services, technology transfer services and in turn fund innovation. This is just like every country has a science organization and an innovation organization where the latter funds the former to generate interesting innovation projects. Hence BIRAC will serve as the funding agency for the industry and charge some royalty for the investment." BIRAC as an organization will be available to service the industry with analysis, technology forecasting, IPR generation. Exploring shared facilities Creating joint research chairs This will help the DBT to explore the space of shared facilities more so in the area of expensive shared facilities-toxicology centers, animal facilities, transgenics, jointly managed technology incubators amongst others. "We have been working on a scheme for joint chairs, where such not for profit research foundations can take more risks and we would fund them as if they were public sector. However, the research foundation and the industry should have a relationship wherein if the foundation produces some technology which is transferred to the main company, some royalty is also given to the foundation to mobilize its research goal," added Dr Bhan. Public-private partnership Need to come up with novel ideas to work upon BIRAC aims at creating more novel and interesting public private partnership models. The DBT has joined hands with FICCI on the lines of the European technology program called the industry partnership platform as a part of it commitment to public-private partnership, which according to the policy would attract an investment of 30 percent of the DBT's budget. Dr Bhan believes that for this to be a successful industry, it will have to come up with novel ideas on the areas where they need help to be able to do more innovation. Nurturing human capital Increase in the density of scientist pool 1. Reversing brain drain In light of the small pool of scientists in India as compared to the country's population, the policy takes into account the expansion of PhDs by the introduction of a new partnership scheme with Wellcome Trust under the NBDS. 2. Fillip to university life science departments The policy aims to give grants to life sciences departments of key universities to scale up their capacity in terms of faculty size, labs, representation in disciplines to run a hugely expanded PhD program. The scheme will select 20 best universities in the country and give a major lift to their life sciences department. 3.Setting up of new universities Eight DBT institutes are to come up that will produce a faculty of 400, that in turn will produce four times the number of Phds, i.e. 1,600. These institutes will not be pure biology institutes but inter-disciplinary units and will have strong translation potential while preserving basic science capacity. 4.Multidisciplinary novel education programs It proposes to start integrated programs in drug discovery science, bioengineering, etc. As many as 13 such novel education programs are expected to start this year. 5.Star colleges and centers of excellence Every city will have a star life sciences college. Facilities for training technicians and teachers will also be created through 50 centers of excellence (CoEs) to enable people to upgrade their skills and understanding. DBT team taps industry for project plans On February 19, 2008, the key team from the Department of Biotechnology (DBT), Government of India, met the industry leaders from all over the country in Bangalore, to seek ideas to implement the National Biotech Development Strategy. This one-day event was organized by BioSpectrum in association with the DBT and ABLE. Dr MK Bhan, secretary, DBT, Dr S Natesh, senior advisor, and KP Pandian, joint secretary and financial adviser, DBT, spent the whole day with over 70 key personnel from the industry and academia. Dr Shrikumar Suryanarayan, director general, ABLE, BioSpectrum Group Editor, N Suresh, moderated the day-long proceedings. Over 70 people from Bangalore, Mumbai, Delhi, Trivandrum, Hyderabad, Chennai and Ahmedabad shared their views on catalyzing the growth of the biotech industry. Some ideas that popped up during the discussion include: 6-8 players can come together and work for GMP training and utilize the pilot plants. Incentive for Indian companies and institutes to make it affordable to make the existing facilities accessible Creating 4-5 shared and accredited facilities which can be supported by the DBT under the BIRAC mecnism. The idea is to identify the gaps in the technology process and Centers of Excellence (CoEs) be set up in the areas of protein characterization and production, bioanalytical /biologicals, and carbohydrate analysis. Invest in scientists with the help of the DBT. Industry should take the lead in partnering. Explore public-private partnerships in medicinal plants and create documents/dossiers. Build a pool of people in toxicology studies, incubation centers for animal biotech, food policy research, etc. Training for teachers ]]> <![CDATA["Become entrepreneurs, don't fear failure"]]> https://biospectrumindia.com/news/95/2321/become-entrepreneurs-dont-fear-failure.html https://biospectrumindia.com/news/95/2321/become-entrepreneurs-dont-fear-failure.html Tue, 11 Mar 2008 12:17:00 +0530 New Page 1 "Become entrepreneurs, don't fear failure" Biocon CMD Kiran Mazumdar-Shaw's advice to thousands of students pursuing their biotech courses in the country. In a free-wheeling interview with Janani Ravindar, Raashi Sreenivasan, Ramesh Krishnan K and Vishal R Patel, all third year Industrial Biotechnology students at Anna University, Chennai, for their magazine, Verve, the Biocon chief outlined the shape of things to come in Indian biotechnology. Excerpts: The media gives a green picture of biotechnology. But what is the ground reality with respect to generating employment and where do you think the thrust of the biotech boom lies? The way I look at biotech and life sciences, I feel India is well positioned in terms of global leadership in this sector. This is a huge segment encompassing agricultural biotech, industrial biotech and pharmaceutical biotech. The kind of opportunities and the growth projections in this sector are huge and, therefore, the dependence and the need for a large number of people to get into this sector are also large. It is a big picture. It is all the more relevant today as companies are expanding and assuming a global scale. Biocon Group itself has several companies like Biocon, Syngene and Clinigene. Syngene is a contract research company that is expanding hugely in terms of scientific manpower. Clinigene is a clinical research organization which is also expanding in a big way. Contract research companies are growing by leaps and bounds. The reason being, the global pharmaceutical patterns are changing and the pharmaceutical companies clearly realize and recognize the act that they have to increase their bandwidth and bring the cost down. The only way they can do it is by outsourcing services to companies in countries like India. So the number of scientists, we will need to support such a sector, will increase exponentially in time. In the clinical development of drugs, companies have to bring down the cost. This can be done by doing a large part of the drug development in India. So we need a large number of clinical research assistants, who can oversee clinical trials, a large number of investigators who can conduct such trials, and bioanalytical scientists, who can conduct the trials, get back to labs and measure the effects analytically. Coming to the different fields in the sector where the thrust lies today, we are aware of the climate changes and environmental considerations. One of the biggest factors that will have a positive role to play here would be industrial biotechnology and enzyme biotechnology. Biofuels, in terms of alternate fuels, is going to be important. Diagnostics is going to play an important role. So there are a lot of opportunities for scientists and technologists. Here, we also need to address the fact that these scientists and technologists should be in tune with the opportunities available. We need to have specialized academic education which provides employable workforce. Anna University is certainly an institute that is outstanding in terms of the quality of education that is imparted. People need to be trained in some form of a specialization to make optimum use of the plethora of opportunities available, which unfortunately is not happening today in many institutions. What would be your suggestions for the academia that could charter a progressive path for biotechnology in India? When it comes to academia, it has more to do with the approach students have. Take genomics for example. Everyone would know that it is the study of genes and chromosomes, but what many are not looking at, is how it can be applied in businesses. Today genomics is a powerful tool to develop new drugs and to look at diagnosing new diseases. People should expand their minds. In the industry, we expect people to think radically to add value to the company. How are we going to educate people in learning the new sciences? That is what we should be looking at. I would also like to see the government doing a lot more for our teachers because they need to be supported. They are the ones imparting the knowledge and they need to be compensated adequately. It is not only in terms of the pay. They should also be allowed to run consultancies and take sabbaticals. They are doing such a fantastic job for the country and its future. So they should be rewarded. Has the Indian biopharmaceutical industry made a mark in the world? Why is it that we still need a multinational collaboration to release a drug? The Indian biopharmaceutical industry has certainly made its presence felt in the world. As for the collaboration with other MNCs in the world, it is because we in India have been used to generic drug development. The whole concept of novel drug development is very new to us. Since we are used to taking the abbreviated path of generic drug development, we do not understand the risks involved in new drug development. We do not need to go through the whole regulatory process in the former. But we (Biocon) have decided to go in for new molecules. We partnered with a Cuban research institute, which had developed some new antibodies. We decided to take the risk of bringing those antibodies here and taking it through the regulatory path. We had no surety of its success or failure. We just knew that the probability of success was high. The clinical trials took a long time-about two-and-a-half years--and if they had not been successful, we could not have entered the market. Fortunately for us, the outcome was positive. The indications we launched it was for a certain head and neck cancer. So now we need to do clinical trials to make it work for other cancers. Most of the companies are hesitant to spend so much time and money. That is why we have so many companies following the generic path. Also, we do not have many funding mechanisms to fund such long-term plans. We are used to the IT model nowadays. But that is a services model. Because of the fear of failure in research, we are not getting many investments. The capital market in the country is risk averse. The whole mentality right from share holders to the financial investors is not to take risk. As long as we have a fear of failure and are averse to taking risks, we can never develop drugs without a partner. How do we ensure the accessibility and affordability of drugs for the common man, especially in the developing world? That could be done if the drugs are developed indigenously and that is what we are doing. We have developed the cancer drug in India to make it accessible to the common man. For instance, we at Biocon adhere to the strategy that we may license the product to others but we will not give away certain territories like drug development. We have what is called the "India strategy", where we develop drugs in India to bring down the costs. Even as I say this, I will add that we also have to be realistic about it. We cannot be too judgmental because the companies have to take decisions that are good for their shareholders too, and that may not be always good for the public. Do you think this wave of entrepreneurship is India is only a temporary phase or is it here to stay? What are the hurdles an entrepreneur would face today? Tell us about the setting up of Biocon and the challenges that came with it. Entrepreneurship is a very exciting field. It allows you to create and build things with your own hand. But it is not an easy business. Certainly in the early years, it is very tough. For instance, I started my company in a garage literally. It is not an exaggeration that very often I did not have money to fill petrol in my car. I used to travel by train to reach places across the country. Those were tough times but when you are building something on your own, it is very exciting. I do not look at my early years as times of hardship. I was willing to do anything and everything to make it work then. That sense of purpose and challenge is what entrepreneurship is all about. I would say this to any young entrepreneur, to go about it with a spirit of challenge and purpose. Every time you overcome a challenge, you have a sense of fulfillment and achievement. Today it is just getting bigger for me, but when I achieved something initially, that was very exciting and rewarding. So, entrepreneurship is not any easier now than it was way back then. Those days the challenges were different. Those days it was about being a pioneer. That path involved a lot of risks and experimentation. Today we have a lot of companies to look at, learn from and emulate, but it is also competitive today. This has become a fiercely competitive segment now. One has to constantly think of differentiating herself or himself from the rest. So, each time brings with it a new set of challenges. What is your message to the student community? First and foremost, the fear of failure should be erased from our minds. In India, we have inherently been raised with this fear. But in the western world, people take that as a learning experience and that should be emulated here too. Take my case. My own life has been a series of failures. I failed to get into medicine. So I took up brewery. I failed to become a brew master. So I set up my own company. I also failed to get finance initially and after I got that, my technology did not work the first time. So we need to learn from failure, pick up from there and move ahead. We need to obliterate this fear of failure in us. We should not get disillusioned by failures. We can always rise above that and move on. Another observation is that, many students pursue science at an academic level but not as a career. I would like to see more students pursuing a career in science and see that they do not get delinked from it. Today, science also pays well. It is a very exciting sector. Not everybody had the ability to pursue science. But those who pursue science should keep in touch with it. It teaches us a lot.   ]]> <![CDATA[Budget 2008-09 satisfactory, says industry]]> https://biospectrumindia.com/news/95/8097/budget-2008-09-satisfactory-says-industry.html https://biospectrumindia.com/news/95/8097/budget-2008-09-satisfactory-says-industry.html Tue, 11 Mar 2008 12:14:00 +0530 New Page 1 Budget 2008-09 satisfactory, says industry Union Budget 2008-09 has been positive for healthcare on the macro level, given brownie points to the pharmaceutical industry, agriculture and banking sector in particular, which can have a ripple effect on the biotechnology industry. The who's who from the biotech industry voice their thoughts on Finance Minister (FM) Mr P Chidambaram's populist budget and its repercussions in the coming financial year Kiran Mazumdar-Shaw, CMD, Biocon, Bangalore The healthcare sector is a major beneficiary of Budget 2008. India's emerging role as being the preferred destination for drug development coupled with an increasing need to bring down drug prices have been the key factors in this year's budget sops. The sops have come as a pleasant but welcome surprise and have more than met the industry's expectations. An 8 percent reduction in export duties along with export duty exemption for indigenous life saving drugs and 5 percent customs duty reduction for imported LSDs will certainly reduce drug prices. This is a better way to address healthcare costs rather than drug price control. Perhaps the most important tax benefit announced for the sector is the 125 percent weighted average tax deduction on outsourced R&D, which sends a strong signal of the potential that discovery research holds for the Indian pharma and biotech industry. Talent and skill building has also received due attention. INSPIRE is a good initiative which if implemented well will have a significant value add to our talent creation efforts. Finally the concept of gender budgeting is a welcome initiative, which will have positive societal impact Dr Cyrus S Poonawalla, Chairman, Serum Institute, Pune I feel the budget could have been much better for the biotechnology industry. The finance minister has brought out a budget which has done precious little for this industry. While concentrating on other sectors he could have also focused more and allocated more to this industry. Supreet Deshpande, CEO, VLife Sciences Technologies, Pune From the perspective of biotechnology sector, the one major positive I am seeing in this budget is a risk capital fund under SIDBI planned for 2008-09. This is critical for the biotech sector given the inherent risk in the discovery process. We will have to read the fine print once available to understand practicality in this endeavor but it certainly is a good starting point. If the fine print does not deter SIDBI investing in longer 'Investment to Return' business model, this initiative can go a long way in helping the Indian biotech sector in optimally commercializing their intellectual property (discoveries) through licensing after completing 'higher value inflection' milestone." Absence of industry-ready scientific research workforce is one of the major constraints in the growth of biotech sector in India, in spite of large number of graduates and postgraduates who are academically qualified. An initiative like Institutes of Biotechnology on the lines of IITs, focused on practically ready workforce could have been a great resource. K V Balasubramaniam, MD, Indian Immunologicals, Hyderabad The Union Budget has a number of positives for the pharma biotech industry, mainly the reduction of Cenvat to 8.24 percent, the 125 percent weighted deduction to outsourced research, reduction in customs duty on raw materials for ELISA kits to 18.72 percent and select vaccines and select bio-therapeutics to 9.36 percent. It has not done much on the service tax side, especially for export related services and on the Fringe Benefit Tax. We were expecting some relief on the corporate tax due to buoyancy in tax collections, but were disappointed. Nevertheless, it is a positive budget for the pharma biotech industry. Dr GSK Velu, MD, Trivitron Group, Mumbai It seems like the government has again failed to recognize medical technology as an industry, which is reeling under unprecedented tax burden (36 percent ). There was no special mention made for the industry and no reduction in custom duties for the Import of medical equipments/ devices. The government has not given any incentives like capital grants and subsidies for local manufacturing of medical devices as well. The Finance Minster has proposed to increase its healthcare allocation by 21.9 percent and has extended a 5 year tax holiday for setting up hospitals in non- urban cities, but this however will not reduce the cost of healthcare in the country, until the cost of medical equipments are reduced. Health of the common man has been neglected and so has been the government's attitude to the Indian medical equipment manufacturer. Habil Khorakiwala, Chairman, Wockhardt, Mumbai This year the FM has very generously accepted a little more from our wish list. With a tax holiday for the next 5 years for setting up hospitals in tier II cities and rural India, the improvement of healthcare services in the country will get a major boost with the active participation from the private sector. V S Upadhye, Director, Labindia, Gurgaon This is certainly a historic budget. I am sure the health care sector and pharmaceutical sector will be greatly benefited. I am not sure exactly what is in it for biotechnology, but in general the corporates will be happy even though the structure for direct corporate taxes is not altered.   Dr Krishna M Ella, chairman, FICCI's National Biotechnology Committee and CMD, Bharat Biotech, Hyderabad We rate the budget very highly since it deals four pillars of our society and human kind. The following points can be highlighted. Higher Education was emphasized in the budget. 16 central universities and 3 IISc are going to be set up which will be good sign for human resource development. Innovation fund as fellowship was created for fuelling new ideas for young people to explore their ideas. Thus for the first time, the budget has recognized innovation. The budget increase for Polio Eradication program will also help some vaccine companies. Customs duty for raw materials used to manufacture of ELISA kits reduced to 5 percent. Custom duty on following drugs/ kits used for treatment of cancer, diabetes, asthma, Hepatitis B, etc, and bulk drugs for their manufacture, reduced to 5 percent including CVD for these products made zero. Final import duty will be less than 10 percent which is good sign for diagnostic companies in the country. Many vaccine companies will also benefit due to reduction in custom duty. This will benefit many MNC who are importing the various combination vaccines into the country. In case of all drugs (formulations), excise duty rate has been reduced to 8 percent. This is good for biopharmaceutical manufacturers in the country. In general, the budget is a very good sign. Ranjit Shahani, VC & MD, Novartis India, Mumbai Overall, Budget 2008 for the healthcare and education sectors is positive. The increase in healthcare allocation by 15 percent to Rs 16,354 crore is a welcome move. Further, the increased focus on the healthcare sector with a five-year tax holiday being granted for setting up hospitals in non-urban areas is good for the economy. This will ensure healthcare reaches those who have no access for even minor ailments. The allocation of Rs 992 crore for the National AIDS programme is a step in the right direction. Reduction in excise duty on all pharmaceutical products from 16 percent to 8 percent is welcome as is the proposed reduction in customs duty on life-saving drugs. We hope that customs duty on these drugs will soon be down to zero levels. All these efforts together with the reduction in Central Sales Tax from 3 percent to 2 percent should help bring down drug prices. Industry wishes that more was done for R&D. We had hoped for a 10 year holiday of 200 percent weighted tax deduction for both in-house and outsourced R&D. This would have provided a boost to local R&D and help companies active in this space move up the value chain. In the near future, we hope the Finance Minister pays heed to the long standing request of industry to do away with FBT on physician samples and also tones down the penalties on transfer pricing adjustments. Ashwin Thacker, CMD, Flamingo Pharmaceuticals,Mumbai The budget is good for pharma industry as such due to reduction of excise duty from 16 to 8 percent and nil for anti AIDS drugs. Also on bulk drugs the custom duty has decreased from 10 percent to 5 percent . Interstate purchase of goods will be cheaper due to reduced cost. The increased focus on the health sector is welcome. Shailesh Gadre, MD, ORG IMS This is a very positive budget for healthcare, hospitals and pharma, with new tax exemptions for hospitals, pharma excise duty reduced, Anti-AIDS drugs exempted from excise duty and life saving drugs custom duty reduced to zero. Finance Minister has also proposed to allocate Rs 16,534 crore to healthcare sector, which contributes to 6.05 percent of GDP, for FY09. Its indeed a good step,Government contributes only 0.52 percent of GDP for the healthcare sector, whereas most established economies spend 7-10 percent of GDP on healthcare like forexample, US spending on the healthcare is over 14 percent of GDP. The Indian healthcare delivery market is estimated at USD 18.7 billion. Nearly 65 percent of the healthcare services market has been captured by the private sector. The industry is growing at about 13 percent annually and is expected to grow at 15 percent over the next four to five years. Tapan Ray, Director General, OPPI The Finance Minister has rightly focused in improving the healthcare infrastructure building: by increasing healthcare allocation by 15 percent to Rs 16,354 crore; by extending the 5-year tax holiday for setting up hospitals in tier-2 and tier-3 regions for providing healthcare in rural areas from April 1, 2008; and by proposing new Indian Institutes of Science Education and Research at Bhopal and Thiruvanthapuram to provide additional scientific talent required by the industry. The pharma industry also thanks the finance minister for reducing the transaction costs of medicines by reducing the excise duty pharmaceuticals from 16 percent to 8 percent; by reducing Central Sales Tax from 3 percent to 2 percent and for reducing customs duty on specified Life Saving Drugs from 10 percent to 5 percent.   ]]> <![CDATA["Biotechnology is a tool in the toolbox of technology to increase productivity"]]> https://biospectrumindia.com/news/95/2594/biotechnology-is-a-tool-in-the-toolbox-of-technology-to-increase-productivity.html https://biospectrumindia.com/news/95/2594/biotechnology-is-a-tool-in-the-toolbox-of-technology-to-increase-productivity.html Tue, 11 Mar 2008 12:12:00 +0530 New Page 2 "Biotechnology is a tool in the toolbox of technology to increase productivity" -Clive James, chairman, ISAAA The International Service for the Acquisition of Agri-biotech Applications (ISAAA) announced the global status of commercialized biotech/GM crops for the year 2007 in Delhi recently. The new report released by ISAAA indicates that during 2002-2007, there was a 125-fold increase in Bt cotton in India, which is four times the 67-fold increase for global biotech crops during the 12-year period from 1996-2007. Not only are farmers planting more biotech hectares, but also adopting varieties with more than one biotech trait. Developing countries (12) surpassed the industrialized countries (11) and the growth rate in the developing world (21 percent) was more than three times of the industrialized nations (9 percent). Speaking on the occasion, Clive James, chairman ISAAA said, "2007 has been the year of 12 for GM crops-GM crops are in their 12th year of commercialization, biotech crop area has increased by approximately 2 million hectares in the past five years, 12 million farmers have planted GM crops in 2007 and 12 developing countries using the technology." In an interview, Clive James shares his views on the future of GM crops. Excerpts: How do you see biotech crops addressing the needs for sustainable development? Quoting Norman Borlaug, the father of green revolution, 'I have only bought you time, you need to invest in technology', whenever we talk of biotech, we need to find out how it is related to the feed of the world. Today we see three out of four people in the world dependent on agriculture. The last few years have not only seen an increase in commodity prices, but also an increase in the world population and it is estimated that in the next 50 years, the global population will consume as much food as it has consumed since the start of agriculture. It is the most formidable challenge in front of us in the light of the increasing world population. Conventional crops will not allow one to double food production, neither will biotech crops. Biotech is not a panacea. We need to select the best of biotech and the best of conventional for this so that we can optimize on both and move forward with a radical approach. This would far better be able to address the need of the consumer who needs quality product at reduced prices. GM crops have already contributed to the alleviation of poverty in India, China, Thailand and the Philippines. Biotechnology is not a panacea, it is a tool in the toolbox of technology to increase productivity. What traits do you see in the next breed of GM crops? Right now the genes in the crops are more for agronomic usage, but in the coming years we can have genes with quality, genes for proteins, amino acids. By 2010, we will see crops GM crops having stacked genes, say a set of 8 genes in a genome, like a cassette. We have to understand the need of the farmers in terms of GM crops. Not only does the crop need to be disease resistant, pest resistant, but also tolerant to drugs. Hence multiple genes is the need of the farmer. In the US, 30 percent of all crops have stacked genes, which is what the need of the farmer is. What are some of the GM crops to be available commercially in the next few years? By 2011 golden rice would be available in all countries.We also see biotechnology playing a role in biofuels that would further help reduce costs. Countries like Africa, Egypt and Burkina Faso will also soon be taking up biotechnology and GM crops in a big way. We see crops like rice and brinjal in Asia and India. We see wheat following rice. Biotech wheat was developed about 3-4 years ago, but it was decided that it was unfit for human consumption. However, its position is now being reexamined. A trait related to a microtoxin, fuminocin is being looked into. Biotech wheat will lower the concentration of this toxin. We would also see a move from fiber crops to feed crops like wheat and rice. Not all countries are proponents of GM crops, some are fierce rejectors as well, such as the EU. Your comments EU might be one of the fierce rejectors of GM crops but it has registered a 77 percent growth with 10,000 hectares. Developing countries have registered a higher growth than industrial countries. Out of 27 countries in the EU, 8 are using GM technology, France banned GM a week back. Russia is close to an approval of GM potato. Romania is the only country in the world where we can increase the production of Bt crops by 3 times. ISAAA believes that people who can have organic food should have it, people who want to have conventional food should have it, and those who want to have biotech food should have it. It's only people who should have the power to make objective decisions. GM crops have faced a few hurdles as far as their acceptance is concerned. How do you see this change in the future? If we look at pasteurized mik or irradiated foods, they faced the same acceptance issues as biotech crops. We see an increase in the no of countries to 40 from 23 and in the no of farmers to 100 million from 23 million. Rice would be the second decade of commercialized GM crops. Golden rice being developed in China and then be commercialized in India and will be the crop of the poor. Multilocational trials have been completed in India. Bt rice leads to an increase in the yield of 4-5 percent on 30 million hectares of land. There is an 80 percent decrease in the insecticide spray on food crops as well. Economically it will lead to an increase of 4 million dollars per year for an average farmer. -Shalini Gupta     ]]> <![CDATA[Public-private partnership]]> https://biospectrumindia.com/news/95/4568/public-private-partnership.html https://biospectrumindia.com/news/95/4568/public-private-partnership.html Tue, 11 Mar 2008 11:15:00 +0530 New Page 2 Public-private partnership Networking and meaningful collaborations between the public and private institutions must be encouraged to develop research competence Dr KK Narayanan, managing director, Metahelix Life Sciences Our country can boast of having many public institutions and university labs that have the research competence to develop biotech products. However, examples of successful product development and commercialization by these centers are few and far between. It does not in any way justify the public resources spent over the years, both on the physical infrastructure as well as on the scientific talent. Often times, it has been the lack of product-focus that leads to the wasteful dissipation of the limited resources. Such a situation can be condoned if we are making path breaking discoveries that will give us a leadership position in the scientific world. The stark fact, however, is that our scientific output in the life sciences area, if measured in terms of the number and quality of peer reviewed publications, is not commensurate with the public money spent on these centers. While it is true that there are several instances of subcritical infrastructure and sub-optimal project funding, resulting in all the resources and time being wasted, that is not always the case. The real value of biotechnology is in products, especially in the context of a country like India. While there is a further need for creating research facilities and capacity building for life science research, there must be an immediate review of the projects to bring about a focus on products or solutions to specific problems This can be brought about by encouraging networking and meaningful collaborations between the public and private institutions. One of the first scientific leaders of our country to recognize this fact is Dr Joseph Thomas, who after a distinguished stint as a scientist at the biological sciences division of the Bhabha Atomic Research Centre (BARC) went on to become a founding member and head of the biotechnology division of the SPIC Science Foundation, a fine research center established under the aegis of Southern Petrochemical Industries Corporation, one of the leading corporations in South India, in the late '80s. He then went on to help in establishing a biotechnology department in the Indian Institute of Technology, Chennai. In the numerous committees of the government and the research advisory councils of public institutions that he served with distinction, he stressed on bringing the public and private sectors together in a binding partnership for product development. At 73, when he was still very active as a thought leader and a much sought after speaker, he suddenly passed away just a few weeks ago. He will surely be remembered, not just as a very good scientist, but as one of the early driving forces behind the now growing momentum towards forging public-private partnerships in the Indian biotech sector. In recent years, there is a growing incentive for the private sector to make investments into life sciences research and development. Such investments are beginning to bear fruits. However, resource constraints, and the high risk perception, especially of regulation and value capture for biotech products, have made the private sector take a rather cautious approach towards research. Innovative ideas, which are usually attended by a high risk of failure, are often not pursued. Government support directly to the private sector can mitigate the risk of such research projects so that the capacity and experience of the private sector is leveraged appropriately for development of novel products that can have value in addressing the health and agricultural problems of our country. The new biotechnology policy unequivocally recognizes the importance of the private sector participation in biotech innovation. In the 11th plan it sets aside 30 percent of the budget of Department of Biotechnology, which is indicated to be around Rs 6,500 crore, for Public-Private Partnership Programs. Some quarters have expressed concern on whether our establishments and systems can absorb such an investment to produce the desired outcomes. I believe that given the size and needs of our country and the promise that biotechnology holds in addressing our problems, this public investment in research and development cannot at all be seen as excessive. However, it calls for prudence and efficiency in spending if the full value of this investment has to be realized in the next five years. In the hurry to spend the allotted budget, as we have seen often happening in government, if we have a situation where "money chases the projects", we will see this investment squandered on dud projects. On the other hand, if done wisely, this investment can prepare India to take its rightful place among the global biotech industry.   ]]> <![CDATA[Avesthagen's Testy Toast]]> https://biospectrumindia.com/news/95/2012/avesthagens-testy-toast.html https://biospectrumindia.com/news/95/2012/avesthagens-testy-toast.html Thu, 07 Feb 2008 15:18:00 +0530 New Page 1 Avesthagen's Testy Toast Innovation is the key to success in the biotech industry and having one's own intellectual property rights (IPR) will determine the progress of companies in this emerging segment. Dozens of entrepreneurs, who have entered the segment in the last six-seven years, are investing considerable time and energy to remain competitive through innovation. This spirit is best exemplified by Bangalore-based Avesthagen, founded by Dr Villoo Morawala-Patell. Starting from a small lab inside the National Center for Biological Sciences (NCBS), in Bangalore, Avesthagen has been on a patent filing spree in the last few years. By the latest count, Villoo's Avesthagen has filed over 160 patent applications and many more are in the works. The company is now poised to reap the benefits of the IPR it created so far and some two dozen products are expected to come out of the Avesthagen stable in the next two-three years. When she pulls off, what she has been talking about so far, it is certainly going to make many of her peers to sit up and take more than a cursory notice. It is the Budget time in the country and the biotech industry too has a set of demands to be addressed by the Finance Minister. The industry has been regularly seeking tax exemption for the expenses incurred in filing international patents. One hopes Mr P Chidambaram will fulfill this long pending demand of the IPR-driven biotech industry. There are a few other demands such as providing 150 percent weighted tax deduction to all research based companies registered with relevant government agencies, service tax exemption to all research-based companies and those involved in pre-clinical studies of drugs, "priority sector" tag for lending by banks to biotech companies, exemption from withholding tax for technology licensing by biotech companies, and removal of customs duty on import of key raw materials required to manufacture diagnostic kits to detect various infectious diseases. Another major demand relates to setting up a Biotech Innovation fund. Finance Minister should consider this seriously. BioSpectrum has calculated that the nation's bulging foreign exchange reserve, which exceeds $270 billion, could be invested efficiently and could easily fetch annual interest amounts exceeding $10 billion. The government can consider allocating at least $1 billion to set up an Innovation Fund in order to support the industry to take up high-risk research efforts. As indicated in January, the results of the second part of the 4th BioSpectrum Top 20 BT Schools survey are appearing in this issue. In the private category, the relatively new Sastra University, based in Thanjavur in Tamil Nadu has emerged as the No.1 institution, relegating the leaders of recent surveys to lower ranks. The No.2 slot too has been taken up by another institution from the state, the SRM University, based in Chennai. Both these institutions have benefited from significant investments made in recent years in upgrading their research infrastructure through various research projects. Almost all the other institutions that figure in the Top 20 list have made large scale investments in boosting their infrastructure, laboratory facilities and linking up with the biotech industry in a big way. They are all reaping the benefits of these investments now. The National Biotech Policy is now moving into the implementation stage. BioSpectrum is planning to organize a day-long interaction between the industry and the DBT-team led by Dr MK Bhan in Bangalore on February 19, 2008 to discuss the way forward. Other details will be conveyed to you in early February. <sureshn@cybermedia.co.in> ]]> <![CDATA[Time for developing swadeshi kits]]> https://biospectrumindia.com/news/95/1266/time-for-developing-swadeshi-kits.html https://biospectrumindia.com/news/95/1266/time-for-developing-swadeshi-kits.html Thu, 07 Feb 2008 15:05:00 +0530 New Page 1 Time for developing swadeshi kits Dr MK Bhan, secretary, Department of Biotechnology, Government of India, addressing the delegates during the workshop on "Opportunities and Limitations in Developing Diagnostics: Road Map for the Swadeshi Kits", organized by Yashraj Biotechnology, Navi Mumbai. The biggest driver for molecular diagnostic technologies is the promise of better preventive and therapeutic drugs India has, in recent years, emerged as a very strong global player in the area of biotechnology. Availability of intellectual capital, skilled manpower, developed infrastructure and the biodiversity in terms of human gene pool are some of the major strengths of the Indian biotechnology industry. It is anticipated that the consumption of biotech products in India will grow to approximately $4.3 billion in another three years. Revenues to the tune of $5 billion are expected to be generated by the biotechnology sector and one million skilled jobs will be created through products and services in the next few years. In wake of this, it is natural that venture capitalists are eyeing biotechnology as one of the thrust areas of investment opportunity. As Dr MK Bhan, secretary, Department of Biotechnology (DBT) said, "the field of biotechnology is not only good business, but it also produces wonderful solutions for our health care, our agriculture, our environment and indeed for creating more environmentally friendly manufacturing technologies". The DBT has invested over Rs 1,000 crore in public research institutions alone since its inception in 1986. There exists several opportunities for venture capitalists in biotechnology such as biopesticides, biofertilizers and diagnostics. Molecular diagnostics Diagnosis by employing modern day technological tools is of paramount importance in the clinical management of patients. Over the years, a variety of diagnostic assays have been developed, the availability of which has shown immense potential in therapy. Within the broad umbrella of diagnostics, the traditional methods often become of clinical use after the onset of disease or after the appearance of clinical or subclinical symptoms. On the other hand, with molecular diagnostic tools, it is feasible to detect pathogens even before they manifest their action on body functions, as well as identify the individuals who are at risk of developing a specific disease in their life span. It is also now possible to predict the course of some diseases, evaluate the efficacy of drugs in the form of patient's genome and prescribe alternative and efficacious drugs using gene or non-gene based diagnostic platforms. It is in view of this potential that the biggest driver for molecular diagnostic technologies is the promise of better preventive and therapeutic drugs. The discovery of the human genome and the subsequent expansion of proteomics research combined with other emerging technologies are facilitating the development of need-based personalized technologies as well as therapies. Another major advantage of most molecular diagnostic testing is that these tests can be performed on very small amounts of tissue and other biological materials obtained using different types of procedures, including small biopsies, fine needle aspirates and also archived material. One of the major areas where molecular diagnostic testing can be of great benefit is oncology. It is now possible to detect small numbers of malignant cells in cytological preparations or biopsies through the clinically validated use of clinical markers. Molecular signatures can help in the detection of minimal residual or recurrent disease and can help distinguish a metastasis from a second primary tumor. Genotyping can effectively detect minimal residual disease and classify lymphoma subtypes. Now it is also possible to detect somatic genetic alterations of solid tumors in clinical settings. Tools are available to provide a molecular fingerprint of tumors that are predictive of the response to specific therapies. It is anticipated that application of molecular pathology and molecular diagnostics will further revolutionize the drug discovery and development process, customize the selection, dosing and route of administration of existing and new therapeutic agents, and truly personalize medical care. Double-digit growth It is widely anticipated that during the next five years the molecular diagnostic industry will continue to grow at double-digit pace to meet increasing demand for rising incidence of infectious and vector-borne diseases which account for over 325 million disability-adjusted lost years per year. In addition, India is also becoming a hub for diabetes, cardiovascular diseases and a variety of cancers. Above all an increasing educated public will demand more information about their predisposition for serious diseases and how these potential illnesses can be detected in an early stage when they can be arrested or cured with new therapies custom-designed for their individual clinical status. To respond to this demand, the pharmaceutical companies will have to develop more efficient and less toxic integrated personalized medicine drug and test products. The global molecular diagnostic industry which was about $3 billion two years back is expected to expand to $12 billion in 2010 and $35 billion in 2015. The in vitro diagnostic market in India is about Rs 800 crore accounting for less than one percent share of the global market. The Indian market is growing by almost 15-20 percent annually. In India most of the molecular diagnostic tests are carried out through kits, which are imported and expensive. For example, the cost of PCR-based assays for different pathogens in India is in the range of Rs 1,300-2,000 per assay, which is beyond the affordability of a common man without any health insurance. These costs can be drastically reduced by developing indigenous assays. Availability of affordable, sensitive and specific diagnostic methods is expected to change the face of medical care in our country. It is therefore essential to focus on technological advances such as in vitro diagnostics, noninvasive diagnostics and point of care diagnostics, which could lead to major improvements in the accurate detection, characterization and diagnosis of human diseases, as well as keep the costs low. Navi Mumbai-based Yashraj Biotechnology Ltd (YBL) is one of the Indian biotech companies that is focused on molecular diagnostics. YBL uses the proteins purified from human biomedical waste as reagents for the development of indigenous kits. Thrust on swadeshi kits In an endeavor to develop cost effective diagnostic kits and indigenize the technologies, YBL and the DBT had recently organized a workshop entitled "Opportunities and Limitations in Developing Diagnostics: Road Map for the "Swadeshi" kits. The meeting identified the unmet needs in the area of diagnostics in the country, debated on whether these technologies be bed-side or laboratory-based, the potential target users of such technologies, and the need for public-private partnership in such ventures. Development of diagnostics on the principles of immunology, DNA detection system and instrumentation were debated at the workshop. Another area of diagnostics of potential future application considered was the use of nano-diagnostics and miniaturization technologies which have been recognized as promising solutions to provide low-cost microchips for diagnostics. The meeting identified areas pertaining to infectious and vector borne diseases, where development of appropriate diagnostic tools could possibly have a major impact on the global human health. The discussion focused around development of diagnostics for cancers, acute lower respiratory infection, HIV, diarrhoea, malaria, tuberculosis, and sexually transmitted infections. These diseases result in a significant loss of human life. Indigenization of such technologies will have to factor in several aspects like affordability, wide range of ambient temperature in the country, and availability of minimal essential infrastructure support including water and electricity. The challenge therefore lies not only on the technical front but also on development of an appropriate user interface. This initiative of YBL and the DBT to bring the industry and the academia together will pave the way for speedier development of diagnostic and therapeutic products. The workshop therefore raised hopes and opportunities to develop "Swadeshi kits" for diagnosis of various diseases. Consortium approach of bringing academic institutions and industry on the same platform, which is mutually beneficial, is essential. While the academic institutions would generate new knowledge and intellectual property, the industry would ensure that the research done is useful, relevant and applicable in real life. In addition, the industry can also augment the meager resources generally available to the academic institutions through government agencies. In fact a tripartite agreement between the three institutions at the conceptual stage of a project would see more dreams turning into reality. To accelerate the development of molecular diagnostics, it is also essential to establish dedicated centers for research, development and evaluation of novel molecular diagnostics and their constituents. The vision of these centers should also be to ensure that the diagnostics are affordable and easily available to the common man.   Chander P Puri, CEO Yashraj Biotechnology Ltd, e-mail: vichin@vsnl.com   ]]> <![CDATA[GMOs in Supreme Court: A colossal waste of judiciary's time!]]> https://biospectrumindia.com/news/95/5398/gmos-in-supreme-court-a-colossal-waste-of-judiciarys-time.html https://biospectrumindia.com/news/95/5398/gmos-in-supreme-court-a-colossal-waste-of-judiciarys-time.html Thu, 07 Feb 2008 14:54:00 +0530 New Page 1 GMOs in Supreme Court: A colossal waste of judiciary's time! Dr Shanthu Shantharam President, Biologistics International, Maryland, USA (sshantharam@biologistics.us) The current GMO cases pending in the Supreme Court is nothing more than an issue of governance and administration and has nothing to do with public safety. In a country where courts are clogged with pending cases that would take another decade or more just to clear the backlog, there is a bunch of urban NGOs wallowing in urban luxuries filing public interest litigations---ostensibly to save the public from the dangers of hapless GM crops. It is unconscionable that some of these NGOs waste so much of court's time on GMO non-issues just to keep themselves in the news, and show their paymasters that they are doing something to rid India of GMOs. This is nothing but a travesty of scientific truths and a public farce. The current GMO cases pending in India's Supreme Court only shows the frustration of the activist groups who have not succeeded much in stopping this technology deployment in the country. It is literally, much hullabaloo about nothing. This has only increased the resolve of the authorities to press ahead with the implementation of the GMO technology. Just recently, the Indian Council of Agricultural Research (ICAR) strongly recommended the use of herbicide tolerant GM crops, and simply dismissed the concerns of the activists stating: there is no scientific basis to be worried about the so-called "super weeds". Well done, ICAR! If one sticks to facts of science and the empirical evidence, then there is no case for opposing GM crops. Now, if only the scientific bodies of the country would come forward and submit their briefs, there is no doubt the honorable court will dismiss all these frivolous cases. Unfortunately, it is the inaction of the scientific bodies of the country and the lack of proactive stance of the government that has left civil society with no other option but to approach the courts, be it the case of GMOs or many other life and death issues of the citizenry. Let us examine the points of one of the farcical cases in which it is charged that releasing GMOs threaten the country side and the environment; leads to the contamination of food chain, and affect biodiversity in an irreversible manner; that inadequate tests are conducted before permitting commercialization of GMOs; the concept of "substantial equivalence" and "generally regarded as safe (GRAS)" have been used erroneously to determine the safety of GM foods; that the "transfection" event used to generate GMOs cause unpredictable changes in gene expression, and are different from those produced by conventional breeding; that they want GEAC to be restrained from allowing the importation of any commodity or product until it is labeled GM free; they accuse GEAC of filibustering with irrelevant technical data, and the rant goes on... You get the drift. One wonders who really is bamboozling the courts with all that unadulterated scientific nonsense! Now, these petitioners quote scientific experts like Prof. Seralini whose recent research interpretation of the MON 810 data was completely rejected by a new scientific panel of the European Food Safety Authority (EFSA). Prof. Seralini is paid piper giving out interpretations according to his paymaster, the Greenpeace. It is amazing that the petitioners don't seem to have even the high school knowledge of how cotton-seed oil is made, and what it contains. The world over, it has been established that extracted oils are completely free of proteins and nucleic acids, and completely inert. The world-renowned scientist who the petitioners consider independent and stands to gain nothing in offering his expert opinion is Dr Arpad Pusztai who was fired for his inept scientific findings of the effect of GM potatoes on rats. UK's Royal Society's panel completely repudiated his findings and he stands aggrieved today that his long scientific career was brought to an abrupt halt. He has an axe to grind against the scientific establishment, and the industry for his stymied career and disrepute. Prof. Dave Schubert has no standing in the field of crop biotechnology at all, and whose ranting is not paid any attention by any respectable group of scientists in the world. Likewise, many scientists quoted in support of their case like Kiran Shakkari, Abdul Qayoom , Gurian Sherman, Paul Foster, Jeremy Smith, Irina Ermakova and many more are well-known GMO baiters, and are on the list of who's who in the anti-GMO circles. Kiran Shakkari and Abdul Qayoom hardly qualify as scientists who are paid employees of one of the petitioners in the case. They have never published anything credible in the mainstream peer reviewed journals. For those who may not be aware of the kind of circus the anti-GM lobby is playing around the world, there is not a day when they don't find an utterance or an opinion against GM crops in some remote publication, and broadcast it through their networks, and the Indian anti-GM lobby picks them up and bandies it as the ultimate scientific truth. Almost all anti-GM scare stories have been completely discredited by mainstream scientific establishments, competent regulatory authorities, and numerous scientific panels, committees, and thousands of peer reviewed publications that have clearly established the safety and superiority of GM crops which is why their acreage is growing by leaps and bounds around the world. The only GM crop commercialized in India, Bt cotton's acreage even beat that of China which started commercialization years before. These petitioners are really disingenuous in presenting only one side of the story. They have never bothered to read more than 4,000 scientific papers about the safety of GM crops from around the world and opinions of the scientific bodies like the US National Science Academy, the UK's Royal Society, Canadian Royal Society, Brazilian Science Academy, New Zealand Scientific Authority, Australian Academy of Sciences, and not to speak of India's own National Academy of Sciences. Suppressing information that is not supportive of their beliefs is wanton mischief, and a deliberate attempt to mislead the courts. The entire case of petitioners running to some one hundred pages is full of innuendos, scientifically baseless charges, quoting discredited scientific information and scientists to deliberately mislead the court. Their level of understanding of modern biotechnology is best exemplified in their use of the term "transfection" to mean "transformation". This may sound like nit picking of a scientific jargon, but it underscores how scientific ignoramuses keep harping on biosafety and environmental impacts of GMOs about which they know next to nothing. You can now figure out how little even their attorney understands. The entire petition reeks of terse prose of unreadable English and Indian legalese. The petitioners have wantonly suppressed or ignored the thousands of peer reviewed scientific publications about the safety of GM crops to humans, animals, and the environment, and most certainly ignored the views and opinions of prestigious scientific bodies from around the world. If a smart lawyer for the respondents were to be equipped with all the pertinent scientific data and information that is freely available, this case could have been dismissed out of hand. There is sufficient and credible information to blow away the entire case into smithereens. It is amazing that such a case has been festering in the court for so long. Unfortunately, there is not much evidence that the respondent lawyer was given all the information needed to blow away this baseless case. With respect to GEAC permitting importation of processed food items, and food derivatives like oil and fats from GM crops, it is a perfectly scientific decision as all of them are inert and none of them contain a shred of nucleic acids (genes) and are incapable of reproduction. It is scientifically ridiculous to suggest they endanger public health, as there is no evidence for it. It is time to educate the judiciary and the bar about the latest developments in the fast developing world of modern science and technologies as they will be arbitrating more and more on such cases in the emerging world of modern technologies. I wonder if someone can file a case against people who wantonly mislead courts in India, and perjure themselves. What is playing around the world in the global debate on GMOs is what is now being described as "contested knowledge"-where the mainstream science is being challenged by some maverick scientists who bear some kind of grudge or animosity against the establishment around the world. There is such a group of biosafety experts of GMOs in India as well, created by the "GMO-Free India" campaign. Almost all of them are retired scientists and seem to be clueless about modern biotechnology, for such a thing did not even exist when they were "active" in science. Modern biotechnology is such a happening field of science that even for practitioners, on a daily basis, if they miss reading a new issue of a journal they would find it difficult to catch up after that. It is really sad that the anti-GM lobbies in India made up of urban NGOs keep propagating the common urban myths about biotechnology, and prevent ushering scientific and technological development, which is the crying need of agriculture in India. The scientific community and the scientific bodies of India must come out of their shell and bust all these myths about modern biotechnology, and assist the authorities in bringing about technological revolution in India's development. They must intervene for a good cause. Ignorance and lack of understanding or lack of proper and credible information never stopped the anti-GM lobby from getting involved to become a public nuisance, but somehow Indian scientists and the scientific establishment shy away from doing what is right for the nation. The Indian scientific establishment must become active and reach out to the media and the public to create awareness and educate them.   ]]> <![CDATA[Catching them young]]> https://biospectrumindia.com/news/95/2217/catching-them-young.html https://biospectrumindia.com/news/95/2217/catching-them-young.html Thu, 07 Feb 2008 14:45:00 +0530 New Page 1 Catching them young Dr KK Narayanan is managing director of Metahelix Life Sciences and President, ABLE, the Association of Biotechnology Led Enterprises. The views expressed here are his own. The interest in life sciences needs to be revived so that more and more young minds take it up as a career option An understandable concern among parents of students undergoing biotech courses is whether their wards will be able to get suitable jobs. While there is no dearth of graduating students, the common refrain from the industry is that they are unable to find enough talent to fill in the growing number of scientific positions in their organizations. It is not the lack of employment, but the employability of the candidates that is often cited as a reason for this striking paradox. There is something amiss in our biotech education system that needs to be immediately addressed if the lack of human resources should not become a stumbling block in the future growth of this sector. The biotechnology industry in India is growing at a healthy clip of around 40 percent year-on-year in revenue terms. From the current size of over $2 billion (over Rs 8,000 crore), the industry should be doubling in size at least every three years to reach the projected size of over $25 billion by 2020. The present growth rate will not be sustainable as the base becomes bigger, unless there is significant boost to innovation and product development. Today, India is seen as an attractive destination for contract research, primarily because of the cost advantage. For the same reason, the cost of failure, a risk which is inherent in any innovative research project, would be less if it is done in India. India has an unquestionable lead in the area of generic drugs. But these are all the low hanging fruits and would serve us well only for the next few years. The real value of biotechnology is in novel products that can address the growing needs of mankind. And in our country, with over one-sixth of the global population, no one can complain about lack of demand! It is estimated that the global pharmaceutical industry, which is over $600 billion dollars (in sales) would double in the next 15 years and 20 percent of that would be between two countries, India and China. The Indian biotech industry therefore has no option but to make investments in the necessary infrastructure and scientific manpower to promote innovation and product development. The physical infrastructure can be created provided you have the financial resources. Training of skilled human resources, however, is a different ball game and need the revamp of the current biology education system through short and long-term measures that are initiated right away. There has been an unrestrained proliferation of institutions offering biotechnology courses in the country in the last few years. Somewhere along the way it was also forgotten that biotechnology is not a stand-alone science, but is the application of basic sciences, primarily the life sciences-microbiology, botany and zoology, complemented by principles of chemistry and physics. It also draws from the developments in many of the other engineering and technology disciplines like chemical engineering, information technology and material science. While it may be more fanciful to flaunt a degree in "biotechnology" as against one in one of the basic sciences, such a "specialization", that too prematurely, runs the risk of producing candidates who do not have a rounded understanding of the fundamentals of basic sciences. Such candidates, even from good institutes, of which sadly there are too few, will not be able to meaningfully contribute as part of a multi-specialty team, to a project that a dresses a specific biological problem. At best they could be glorified technicians. To add to this, the methods of training in most colleges do not impart the spirit of enquiry nor the necessary experimental and analytical skills which are the basic requirements to be an innovator in an industrial environment. Companies often have to spend many months, if not years, in training before a new recruit becomes a productive member of their team. In these early growth stages of the biotechnology sector in this country, there are not enough companies, which are large enough, that can afford to spend the time or the resources. The creation of an independent national accreditation agency that can ensure minimum standards in biotech education has been mooted by various experts. Continuous faculty improvement programs for existing teaching staff in the departments offering biotech courses is another valid suggestion. In addition, "finishing schools" where students can enroll for a short-term course after their degree programs to gain some of the skills that the industry would be looking for, would be useful. However, these are all at best, ancillary and short-term measures. The real change can happen only if the interest in life sciences, which has been on a decline for the last several years, is revived and more and more young minds take it up as a career option. This effort therefore, has to necessarily begin in schools, particularly the senior classes where the student is at the threshold of making a career choice. There has to be a serious effort to revamp the biology curriculum in schools so that the excitement and the immense promise that this field holds, are not lost on the young minds. Programs that kindle the intellectual curiosity-learning through inquiry and through "problem-solving"- have to be developed. Sadly, this is the one glaring omission in the recently released National Biotechnology Policy,-while there are several measures outlined to improve the undergraduate, masters and doctoral programs, there is nothing in it to catch them young!   ]]> <![CDATA[The flip side of NBT]]> https://biospectrumindia.com/news/95/2055/the-flip-side-of-nbt.html https://biospectrumindia.com/news/95/2055/the-flip-side-of-nbt.html Thu, 07 Feb 2008 13:00:00 +0530 New Page 1 The flip side of NBT Dr Pushpa M Bhargava Former director, CCMB, Hyderabad We all need to work hard within a framework of concern, commitment, objectivity and lack of bias keeping the interests of our people and the country above everything else to reach where the policy wants us to reach There is no question that whatever has been stated in the National Biotechnology Policy needs to be done -just as we need to bring secularism back on the rails, remove poverty and realize equity in regard to development, and so on, in the country. The question is, how? In this connection, I would like to offer my comments on the biotech policy. We do not have an updated science and technology (S&T) policy. The best we have had is the Scientific Policy Statement of 1958 and the Technology Policy Statement of 1982, both of which need to be redone. Biotechnology is closely related to many other areas of science and technology. In the absence of a national S&T policy, any sectoral policy in an area of science is bound to have serious limitations. We have given our view of the components of an appropriate science and technology policy on Pages 134 to 138 of our book, The Saga of Indian Science Since Independence (Universities Press, 2003). As regards the National Biotechnology Regulatory Authority (NBRA), it is not mentioned as to whom it would report. Would it be like the Atomic Energy Regulatory Board (AERB)? If so, its stated autonomy would be nominal; we should surely learn from the experience of AERB over the years. There is no mention of the structure of the Board, from which Department will the salary of the Board Members and the staff of Board come from? Will it be from the DBT or directly from the Planning Commission? There is no mention of the terms of reference of the Board. Then, the success of the NBRA would depend on the quality of the people who man it, and its leadership. We need people on it with high level of professional knowledge, social concern, public credibility, courage, and lack of bias. Past experience shows that unless it is set up directly by the Prime Minister's office, its members are unlikely to meet the above criteria. The same would be true of the DNA Profiling Board. We must recognize, without any aspersion on the quality of work done by the Centre for DNA Fingerprinting and Diagnostics (CDFD, a constituent lab of the DBT), that the objectives of this lab today are basically different from what they were meant to be when it was set up. It is, as of today, just another laboratory in the area of modern biology rather than being a commercial center for DNA fingerprinting, serving both private and public sector, as it was meant to be. (I had a role in setting it up, and was the chairman of its scientific advisory committee and of its building committee, and a member of its governing board.) Ideally, given the circumstances in the country, we need a properly empowered and credible Biotechnology Commission, reporting directly to the Prime Minister or the Cabinet and not to be headed by secretary, DBT. It is this commission that should set up the NBRA and the DNA Profiling Board. As regards to promoting biotech industry, expanding SBIRI, setting up BIRAC to nurture industry R&D, much would depend on who does it and how it is done. We make far too many wonderful policy statements but end up doing things that contravene the good intentions behind the policy statements. This is a national malice and one would like to have seen some kind of a mechanism stated in the biotech policy which would ensure insulation against this malice. "Building world-class human capital" should not be the responsibility of or a part of the biotech policy. This should be a part of our education policy. For example, with the school system in the country in shambles and devoid of any equity, with more than 80 percent of our children deprived of a reasonable school education, and with the dominating sea of mediocrity, the educational sector is a drag on development of excellence and can we dream of producing a cadre of world-class scientists? I should also add that when I was a member of the scientific advisory committee of the DBT, I had asked for an analysis of the number of people who were trained in the biotechnology departments in various universities set up and supported by the DBT, and those who joined the Indian biotech industry. The position in this regard turned out to be dismal. Surely, the present biotech policy should have called for an updated study in this regard to assess the value of the DBT's support to biotechnology education from the point of view of the biotech industry in the country. In fact, the courses in the various departments of biotechnology supported by the DBT across the country, are no different from the courses in modern biology, sometimes in the same university, and the people who come out of these departments of biotechnology are no better suited to be employed in the industry than people who come out from other departments of modern biology, say biochemistry or molecular biology. In fact, what we need are biotechnology technicians, and I would have liked to see a set of courses in various techniques used in biotechnology, leading to a one or two year diploma (or even degree) after intermediate or BSc. Examples of such areas would be genetic engineering, tissue culture, enzyme and protein-based technologies, immunotechnologies, rational drug design, nanobiotechnology, marine biotechnology, peptide synthesis, and DNA technologies such as DNA fingerprinting. As an analogy, the country today needs far more electricians than electrical engineers. As regards to attracting scientists from abroad, we must recognize that good scientists working abroad are not looking for money alone in India. They are looking for facilities and an appropriate institutional culture and environment which is sadly lacking in the country - except in a handful of research institutions, most of which are outside of the ambit of DBT. Shouldn't there have been a clause in the biotech policy, emphasizing the need for identifying the elements of - and creating - the above culture and environment? Centers of Excellence (CoEs) are not established by just wishing them to be there. I have some experience in this regard, both in government and in industry. Shouldn't the biotech policy have explained the need to identify the criteria that a Center of Excellence would need to satisfy and the steps that would need to be taken to satisfy these criteria? The same would be true of the proposed clusters, and the program of beefing up biotechnology infrastructure. Instead of merely putting together a wish list, the policy should have stated what it would involve to translate such a wish list into reality: what sub policies, what kind of people, what order of funds and so on. In our above-mentioned book, we have stated what an ideal biotechnology park in the country should have. None of our biotech parks satisfy these criteria. We have learnt no lessons from successful parks elsewhere: be they in Leipzig, Lund or Stockholm. There is a prime need in the country of a seed testing laboratory using DNA fingerprinting, to ensure that farmers have the seeds they are supposed to have. There is no mention of such a laboratory. The policy does not take into account what has already been done or is in the process of being done, both in the private and the public sector. For example, there is a superb P-4 facility in the High Security Animal Laboratory of the ICAR in Bhopal. Why can't that be used more extensively? There is already an approval of funds for another P-4 facility as well as a Translation Research Laboratory to be set up in Hyderabad. One would have liked to see the biotech policy making a visionary statement: for example, in regard to what the nature of medical and health care would be, say, in 2047 (the centenary of Indian Independence), and how the policy intends to contribute to the compulsions of the new scenario that is bound to emerge. Agriculture used to contribute over 40 percent of India's GDP. This contribution today is less than 18 percent. What steps should we take to have biotechnology increase this contribution? An analysis of major national problems where biotechnology can be of help should have been done in the policy. Agriculture security would surely be one of them. It is an important item on the agenda of major national bodies concerned with our security. Shouldn't our biotechnology policy have stated as to how it envisages to ensure our agriculture security? It is easy to say that we are going to set up many new institutions. But have we made any effort to define as to what goes into setting up a first-rate institution? The DBT's record in setting up new institutions is not enviable (NII was not set up by the DBT). Shouldn't the national biotechnology policy have had a statement which would call for assessment of the performance of the DBT in the last 21 years - DBT being the apex biotechnology organization in the country - against the objectives with which it was set up. I had the privilege of drafting the original note that led to the setting up of, first, the NBTB (National Biotechnology Board) and then the DBT, and I have reasons to believe that the objectives with which the DBT was set up have not been met. We need to identify objectively both the successes and the deficiencies of the DBT, so that we may build on its successes and also work out mechanisms to take care of the deficiencies. I do not for a moment doubt the good intentions of those who are responsible for the National Biotechnology Policy and, as a wish list, it looks impressive with the few outstanding omissions I have mentioned above. However, there is nothing to convince me that it is better than any of the government's (central or state) promises to people at the time of elections. What happens to these promises after the elections is well known. We all would need to work hard within a framework of concern, commitment, objectivity and lack of bias keeping the interests of our people and the country above everything else to reach where the policy wants us to reach. How do we achieve this, is the question that the biotech policy does not answer.   ]]> <![CDATA[Developments in life science instrumentation and market scenario]]> https://biospectrumindia.com/news/95/2099/developments-in-life-science-instrumentation-and-market-scenario.html https://biospectrumindia.com/news/95/2099/developments-in-life-science-instrumentation-and-market-scenario.html Thu, 07 Feb 2008 12:53:00 +0530 New Page 1 Developments in life science instrumentation and market scenario Sanjiv P Karandhikar, vice president, molecular and cellular biology division, Labindia, with inputs from Subramanian Dharmaraj, senior marketing manager, Labindia Life science research in India has been the driving force propelling growth in the analytical instrument market. This has resulted in the development of new products and applications as well as the opening up of new markets Biotechnology has been practiced for hundreds of years all over the world for developing crops and cattle with desirable traits. However, modern biotechnology is less than 50 years old. In the last decade especially, a number of important milestones have been crossed in the area of life science research; the sequencing of the human and other model organism genomes being just one of these discoveries. With the development of these new approaches, not only are life science research laboratories experiencing significant gains in productivity, but biotechnology companies are developing products that would have been inconceivable even a few years ago. Genomic, proteomic and drug discovery applications focus on complex biological systems and exploit molecular processes for furthering basic scientific knowledge, developing new diagnostic tools, and increasing the efficiency of drug development. The key platforms employed for these applications include: DNA sequencers and synthesizers, PCR and Real-time PCR machines, microarray platforms, systems for in vitro and in vivo cell analysis including imaging systems as well as sample preparations instruments. DNA sequencing The Human Genome Project (HGP) has had a major impact on the life sciences, resulting in the development of new applications and tools used across many areas of basic and applied life science research. This has also led to the entry of a number of new players into the DNA sequencing market which has fragmented this market significantly. With a number of new applications and workflows now made possible, a variety of platforms are available from different vendors. Over the last decade significant improvements have been made to DNA sequencing technology. Some of these landmark improvements include shifting from radioactively labeled nucleotides to more safe fluorescent dye labels as well as the move from slab gels to capillary electrophoresis (CE) based analysis. Even entry-level DNA sequencing platforms currently available in the market completely automate all the sequencing tasks that were time-consuming and laborious. Filling the capillary with gel (polymer), sample injection, electrophoresis, real-time detection of labeled DNA strands and converting raw data into analyzed data are all steps that are now automated. This allows researchers to focus on discovery instead of spending time on the technique itself and downstream data analysis. Further advancements include increased throughput, widely accepted standards for internationally acceptable data and significant reduction in "per sample" cost. This has resulted in the development of increasingly versatile applications,genotyping, SSCP and methylation studies to name a few. The development of more efficient and easy-to-use consumables and efficient sample prep kits are now a focus area for all the major players in the market. In India, DNA sequencing technology per se is well-adopted and employed in almost all the areas of life science research. Being the inventor of the first automated DNA Sequencer, Applied Biosystems (AB) dominates the Indian market with its market share thought to exceed 90 percent followed by other players like GE Amersham, Beckman and Licor. Next generation DNA sequencers Predictably, the entry of next generation sequencers will have a significant impact in the market. However, the ability of these platforms to enable novel sequencing applications apart from "de novo sequencing" remains to be seen. Therefore at least for the next few years, market dynamics in the context of technology development is much less predictable. Though it would appear that AB's traditional Sanger-based CE products will maintain their own in the DNA sequencing market at least for a few more years to come. It would be reasonable to expect further fragmentation of the market, with ultra high-throughput technologies competing to become the de facto sequencing standard. Roche/454's Pyrosequencing based GS 20, AB's much awaited solid platform based on sequencing by Oligos ligation and detection technique and Illumina/Solexa's Illumina genome analyzer platform are the three most highly anticipated products in this space in India. Additionally, the Indian scientific community has already expressed great interest in these technologies. Especially in the Indian context, these capital-intensive products would demand high quality informatics capabilities as well as application and service support and that would ultimately differentiate the true leader from others. Thermal cyclers (PCR) The Polymerase Chain Reaction (PCR) was invented in 1983 by Dr Kary Mullis. PCR is now the single most widely used method in the molecular biology space. PCR exponentially amplifies DNA via enzymatic replication, capable of producing billions of copies of a DNA fragment from just a few copies, in less than two hours. There exists a large repertoire of modified PCR-based techniques that is used to perform a wide variety of genetic manipulations. Market dynamics in India The life science research in India has been a driving force propelling growth in the analytical instrument market. For automated DNA sequencer, Applied Biosystems dominates with more than 90 percent market share. Applied Biosystems, Eppendorf, Bio-Rad, Stratagene, Techne, Corbett and Cephied are the major players in PCR market. For Real Time PCR, the focus has gradually changed from hardware to "complete end-to-end workflow based solution". The major commercial players in the microarray space are Affymetrix, Perkin Elmer and Applied Biosystems.   PCR is used in medical and biological research labs for a variety of applications including basic gene sequencing, diagnosis of hereditary diseases, the identification of genetic fingerprints (used in forensics and paternity testing), the detection and diagnosis of infectious diseases, and the creation of transgenic organisms. At the core of the PCR technique, as it is practiced currently, lies the concept of repetitive thermal cycling. This required the development of a very accurate and highly reproducible automated temperature cycling system, known as the thermal cycler. Perkin-Elmer introduced the first commercially available thermal cycler. This platform was based on compressor driven refrigeration technology. Perkin-Elmer dominated the PCR market for almost a decade with their highly well-engineered and reliable products. Gradually, other players also started penetrating the market by introducing more user-friendly and flexible products. The introduction of Peltier-based temperature controlled blocks brought about a landmark change in the PCR market. This was followed by the introduction of interchangeable blocks, multiple blocks, low reaction volume blocks, blocks with high ramping rates all of which were also well received in the Indian market. The introduction of temperature gradient blocks was another key development in the thermal cycler market. The use of molecular techniques in all segments of the clinical, diagnostic and testing markets has been growing by leaps and bounds over the last few years. This is the primary driver for the growth in the PCR market at present. Major players in PCR market in India include Applied Biosystems, Eppendorf, Bio-Rad, Stratagene, Techne, Corbett and Cepheid. Real-Time PCR In the post-human genome project era, the wealth of information now available to the scientific community has spurred widespread use of complementary technologies such as real-time PCR, microarrays analysis. The real-time PCR market in itself has come a long way, since the introduction of the first commercial real-time PCR platform by Applied Biosystems. The focus has gradually changed from hardware to "complete end-to-end workflow-based solution". During the developmental stage of this product line, real-time PCR was perceived merely as an optical upgrade of conventional PCR. But as more sophisticated applications were enabled by the real-time PCR technique, instrument manufacturers also realized that the technique offered great potential and the need for rapid improvements in their platforms. As a result, hardware features including the light source, the detection systems etc. were rapidly upgraded to keep pace with the application development without diluting the cost to performance ratio. Innovative approaches such as virtual filters were also implemented to deconvolute complex fluorescent dye spectra thus achieving better signal to noise ratios. But soon the technology reached its peak and the chemistry became the bottleneck . Even though, there are various real-time PCR chemistries available, two chemistries are widely used by the scientists all over the world. These are FRET-based TaqMan technology and SYBR Green chemistry which is dependent on SYBR Green's ability to bind any double-stranded nucleic acid molecule. TaqMan chemistry is extremely accurate and highly specific and considered to be the gold standard for real-time PCR experiments. However, with proper optimization SYBR green based methods can also work well. Having sensed the need for speed and reliability, technology providers started offering "readymade off-the-shelf" assays, "customized" assays and optimized reagents enabling sample preparation from a wide range of specimens. As of today, the entire focus has shifted to provide complete "workflow solutions" to researchers. This has allowed scientists to focus on the science and discovery rather than the technique. This strategy has largely been successful as witnessed by the wide acceptance of AB's TaqMan assays-on-demand and similar products from other vendors. The most recent and novel innovation in this area has been the adoption of the microarray format for running real-time PCR experiments. This format allows researchers to interrogate the expression level of hundreds of genes simultaneously. With increasing number of scientists wanting a bird's eye view of gene expression at the pathway and individual biological process level, which typically involves a few hundred genes, these real-time PCR based low density arrays have already become a very popular tool. These arrays are also becoming an incredibly powerful tool to analyze global gene expression changes in the entire miRNA gene set. Another significant advantage for scientists is the simple workflow and significantly lower dependence on bioinformatics. Globally more than a dozen companies operate in this space in the Indian market, Applied Biosystems has the highest share of the market with Bio-Rad, Stratagene, Eppendorf and Roche being the other major stake holders in the basic research market. Additionally, Corbett, Cepheid and Techne are also trying to make inroads into this market. As further innovation in instrument technology has been slowing down over the last few years, one can expect that further growth in this market will be mainly driven by innovative reagents and consumables at least for the next few years. Globally there are three major players in the regulated clinical and in vitro diagnostics market-Roche, Abbott and Corbett. This critical market is growing by leaps and bounds but "per sample" cost is the major concern for most end users. Microarray Over the last few years, based on end-user specific application needs, the microarray market has been fragmented into multiple segments such as SNPs, alternative splicing, microRNA, whole transcriptome, ChIP-on-Chip etc. Microarrays are also being offered with increasing amounts of content on a single array. With all these developments taking place and even more in the pipeline, microarray technology in India still remains largely underutilized. The primary reason for this is the lack of sequence information for many of the plant and microorganism species, which are worked on in India. A microarray with appropriate content for these species is not available commercially. Further compounding this problem is the lack of proper training and experienced personnel and especially the lack of strong bioinformatics support. The latter is the major bottleneck for sub-optimal microarray usage in India even in laboratories which work on standard model organisms such as human, rat and mouse. The microarray market can be divided either via end-user requirement into whole genome arrays and smaller customized arrays. It can also be segmented into pre-spotted arrays and custom-spotted arrays. Another way to segment the market is as closed system arrays and open system mix & match type arrays. With the multitude of different platforms and product offerings available, it has become a real challenge to the Indian scientists to choose the right technology for their projects. By and large, Affymetrix is seen as the market leader in this market space in the world for expression arrays and Illumina for genotyping/SNP arrays. As far as Indian market is concerned, flexibility to work with a wide range of species and a wide range of spots per array at a reasonable price are the major selection criterion. Thus, "mix & match" types of open platforms are most preferred in India. The major commercial players in the microarray space in India are Affymetrix, Perkin-Elmer and Applied Biosystems. Bioinformatics Bioinformatics is an interdisciplinary field, which addresses biological problems using computational techniques, and makes the rapid organization and analysis of biological data possible. Bioinformatics plays a key role in various areas, such as functional genomics, structural genomics, and proteomics, and forms a key component in the biotechnology and pharmaceutical sectors.   ]]> <![CDATA[Go bananas!]]> https://biospectrumindia.com/news/95/2468/go-bananas.html https://biospectrumindia.com/news/95/2468/go-bananas.html Thu, 07 Feb 2008 12:32:00 +0530 New Page 1 Go bananas! Low-calorie biscuits from banana peels are soon to hit your local supermarket and be a part of the new generation of health foods, if the invention of Rucha, a 20 year-old college student from Kolhapur is anything to go by It might have been the idea of extracting the best from waste that set Rucha Joshi on a quest to make biscuits from banana peels, something that most of us regard as waste. Rucha, who represented India in the US and Japan, has a patent filed for the CSIR. Rucha's light-bulb moment came in the middle of a banana market (Itawara) in Nanded where she was struck by the sight of wastage of edible banana peels and a few days later a recipe for cooking vegetable out of ripened banana peels further fuelled the idea. This set her off on a project to use banana peel in biscuits, explore the effect of peel addition on nutritive values of these biscuits, and find acceptance of these biscuits by the society. The project She prepared normal biscuits without peel and biscuits containing 10 percent and 20 percent peel pulp. The dough was made by grinding edible vegetable oil, icing sugar, milk powder, custard powder, butter and weight of wheat flour in a mixer to which known weight of banana peel pulp was added and mixed again. It was then molded into desired shape of biscuits and baked in an oven for 30 minutes at 150°C. The advantages It was found that with increasing peel in biscuits, there is a drop in calories/100 g and fat percentage but increase in carbohydrate percentage respectively. Also the fiber content increased with increasing peel pulp in biscuit, which is beneficial for bowel movement and reduction in cholesterol. It was also noticed that there was no change in proteins, moisture and ash content. Thus, with the increase in peel content of biscuits, calories are reduced in the form of fats, which may prove a boon to the calorie conscious people, especially to the diabetic and obese patients. The increase in fiber percentage with increasing peel content in the biscuits indicates its usefulness in preventing constipation and atherosclerosis. The biscuits prepared before 110 days were tested for fungi and none of them showed the presence of fungi during the incubation period of 72 hours indicating that addition of peel pulp does not make the biscuits prone to fungi growth. It was also found out that the aroma of biscuits containing 10 percent peel pulp has been accepted equally by people along with that of normal biscuits without peel. Rucha has found out that the use of banana peels in biscuits is also cost-effective. The peels available from the various industries using banana pulp are required to be processed to convert them into pulp, which is a suitable form for addition in dough. This cost of conversion in the form of labor charges, power consumption, plant cost, etc., may require about 2.5 percent of the cost of dough. Hence, due to 10 percent and 20 percent peel addition, cost will reduce by 7.5 percent and 17.5 percent respectively. Rucha's invention has way to go, if the new generation of health foods hitting supermarkets in India is anything to go by. A case in point is Avestha Good Earth that is developing nutritious alternatives for breakfast, daily snacks, and functional food. She thinks it would be wonderful to come up with a novel product useful to the society, by taking help from companies who are interested to market the product. Meanwhile, she aspires to work in R&D field of biotechnology, particularly genetic engineering. Shalini Gupta   ]]> <![CDATA["We also have a biotech initiative"]]> https://biospectrumindia.com/news/95/1519/we-also-have-a-biotech-initiative.html https://biospectrumindia.com/news/95/1519/we-also-have-a-biotech-initiative.html Thu, 07 Feb 2008 12:23:00 +0530 New Page 1 "We also have a biotech initiative" -Dr Rabinder Buttar, president and CEO, Clintec International Clintec International, the UK based Contract Reseach Organization (CRO), is all set to foray into drug development and has announced plans to expand its Indian outfit in a major way. Located at Bangalore, the Indian arm of Clintec International will be developed into an important global center and serve as Asia's hub for its international operations. The company is focusing on India in a very big way and aims to bring many global projects to India. It plans to increase the head count in India from the existing 25 to about 100 employees in the near future. ClinTec India contributes about 25-30 percent of Clintec International's global revenues. The Bangalore arm of ClinTec will support and drive the work at ClinTec International's newly opened global clinical research Center of Excellence in Munich, Germany. Dr Rabinder Buttar, president and founder, Clintec International, shares the details. What is Clintec's current global positioning? We are just not a global CRO but we also have some biotech initiatives and an American biotechnology division within the company and unlike other CROs we cover many of the emerging companies of the world where no other global CRO is present. We cover the Middle East, North Africa, Central Africa and India as well. The difference with Clintec is that we also have a biotech division, which will split off into a biotech company. The function of that part of the company is going into partnerships, taking drugs and New Chemical Entities (NCEs) to the global market place and also bring products from other countries like the US and Europe to the global market. We have already been successful in entering into a co-development with Dr Reddy's Laboratories some time back. What are your contract services offerings? We offer full services in clinical research. We can do the complete development, right from preclinical stage to clinical development. We advise and guide our clients through the whole development pathway. We guide them with the correct strategy, the trials and the regulatory hurdles. So we offer full consultancy and also do the actual projects, right from writing the pre-development plans to writing the protocols till the clinical trials anything from phase I to phase IV and clinical monitoring and clinical research in more than 35 countries. We have close links with hospitals in more than 35 countries so that we can work with precision. We put the right protocols together and then our CROs across the globe do the actual clinical trials. We usually start of with the feasibility study and start the work. We also do all the regulatory applications and act on behalf of the pharma companies. How challenging is the CRO business? What is Clintec doing to meet those challenges? The CRO business is quite challenging and everyone has to do something different and Clintec has always been different. Clintec is an international organization which is much more flexible. We can do the whole project and we can even guide through any stage of the project when our clients gets stuck. Our flexibility is the key to our success. We can work on the whole development program. We can work on medical writing to data mangement. Also, the organization is privately owned by myself and there are very few such organizations. In January 1997, we incorporated the company in the UK and we are one of the first clinical organizations in India, Romania, Bulgaria, Eastern and Central Europe and we are the leaders in the Middle East. One of the most challenging jobs in the CRO is retaining the best staff. Clinical research needs very good researchers. We are facing a major hurdle in that area in India as the attrition rates have been very high. There is a dearth of good researchers. So we are also actively involved in training and have been doing corporate programs. As a result the attrition in Clintec globally is very very low and in India it is close to zero over the last year and that is quite amazing. How large is Asia-Pacific business for Clintec? At the moment it is not very large for us but I can see huge potential in Asia Pacific in the coming years. In fact with one of our major client, we have relocated our staff to that part of the world because they want to build a bigger base in Asia Pacific. Though at the moment, our interest is high in India, we are looking at being one of the pioneers in China. We are actively seeking partnerships and we have been evaluating and talking with some partners to become a very strong force in Asia. We are considering to tap the Japanese market. We have a large pool of talent who too has worked with Japanese companies. They are very much well versed with the Japanese management. So if there is a Japanese company which requires an European CRO for its clinical trials, we will support it. Can you elaborate on Clintec's investments in Asia Pacific? Investments are still going on as we have expanded our operations and we are yet to get major returns on that. We have been spending a lot on training. The training comes from from organizations like ICR, ICRP and European Medical Writing Association which costs us more than an annual salary of an employee. We have substantially increased our training and development budget. What are some of your future plans? Apart from the Munich global clinical center of excellence, which focuses on clinical research, we have another new center in Glasgow in Scotland, which focuses on corporate functions and the third controlling center is in Bangalore, India. The Scottish government has been backing us. We have received a £1.534 million grant from the Scottish government to create 230 jobs by the next year. I have also been awarded the Entrepreneur of the Year on November 29, 2007 by the Scottish Deputy Minister and the Minister of Health. So we are really prepared for a strong growth ahead. Apart from CRO business, are you also looking at diversifying into other areas? We are looking at biotechnology particularly developing new cancer drugs. You may also be aware of our partnership with Dr Reddy's in developing New Chemical Entities (NCEs). We are also in discussions with several other companies for bringing those to our biotech venture that will also be launched later this year. We are actively developing our biotechnology portfolio and we expect to be a major player in future. In three to five years we may also be looking for an IPO. Jahanara Parveen ]]> <![CDATA["We hope to contribute to the growth and development of India"]]> https://biospectrumindia.com/news/95/2653/we-hope-to-contribute-to-the-growth-and-development-of-india.html https://biospectrumindia.com/news/95/2653/we-hope-to-contribute-to-the-growth-and-development-of-india.html Thu, 07 Feb 2008 12:21:00 +0530 New Page 1 "We hope to contribute to the growth and development of India" -Dr Alpna Seth, managing director, Biogen Idec India is fast emerging as a hot destination for biotech and the proof of the pudding lies in the fact that international companies are opening up their offices here to tap the market. The last year saw US-based biotech company, Biogen Idec, headquartered in Cambridge, Massachusetts, USA, establish its wholly-owned Indian subsidiary in Gurgaon, Haryana. The company which specializes in drugs for neurological disorders, autoimmune disorders and cancer, officially inaugurated its Gurgaon office in October 2007. Biogen Idec already has tie-ups with Roche and Nicholas Piramal for marketing its drugs MabThera and Avonex respectively. The company intends to continue with these partnerships and strengthen them further through its on-ground presence. The Indian entity is headed by Dr Alpna Seth, a long-time veteran of the industry, who has been with Biogen in the US for the past nine years in various leadership roles spanning R&D to commercial. Biogen Idec has already made multi-million dollar investments in India and will continue to make significant investments in the country in the coming years as well along with expanding its operations over the next five years as the company identifies new opportunities, says Dr Seth. BioSpectrum finds out more in a chat with her. What prompted you to open an office in India? What are the advantages that a market like India offers to a US-based company like Biogen Idec? More so, in the context of several big biotech firms setting up shop in India. There are a number of reasons for us to open an office here. One of the prominent ones being that India is one of the most populous and fastest growing world economies with GDP growing at 8-9 percent per annum. With a shift in disease patterns from communicable to non-communicable diseases coupled with the company's strength in discovering, developing and marketing therapeutics for serious non-communicable diseases such as cancer, it is imperative that Biogen better understands and eventually caters to the needs of Indian patients through its presence in India Adding to this, India also provides a large pool of English speaking talent especially in terms of qualified scientists and professionals and we believe that inclusion of Indian sites and investigators in Biogen Idec's global clinical development plans will provide earlier access of our novel drugs in development to Indian patients and allows the company to better understand their needs. What would be the focus of the company in India? Will it be on the same lines as its US counterpart or are you looking at tailoring it to the needs of the Indian market? As a pioneering biotechnology company Biogen Idec is keen to participate in and contribute to building India as a global biotech player and towards this end we are attempting to gain a pragmatic understanding of Indian market needs and dynamics by integrating India into our global clinical development plans, particularly for disease areas of high unmet needs and patient numbers. We are also looking at broadening access of innovative drugs in development to Indian patients and investigators while facilitating the speed of development. The focus shall also be on strengthening of the existing relationships with partners, regulators and service providers and establishing new ones besides exploring R&D partnerships and collaborations with companies, investigators and academic institutions. Overall through an on-ground presence, Biogen Idec hopes to better understand and eventually cater to the needs of the Indian market and Indian patients, which may be very different from the needs of patients in the US or elsewhere in the world. Besides drugs in the areas of oncology, neurology, immunology and cardiology, what are the other areas you're looking at? These four areas remain the key areas of focus for Biogen Idec and within these, we are developing drugs for several serious diseases such as Non Hodgkin's lymphoma, chronic lymphocytic leukemia, solid tumors, multiple sclerosis, Parkinson's disease, Crohn's Disease, heart failure, pulmonary arterial hypertension, Hemophilia B, rheumatoid arthritis and neuropathic pain. Most of the drugs by the company are biotech drugs. Are you also looking at New Chemical Entities (NCEs)? Yes, in addition to a large biologic portfolio of drug candidates, Biogen Idec is also developing several New Chemical Entities. In order to further strengthen your base in India, what are some of the partnerships and collaborations that you are looking forward to? Biogen Idec is interested in exploring partnerships in R&D with Indian drug companies, academic institutions as well as service providers, across the value chain ranging from discovery to development. Several Indian companies have developed strong capabilities, particularly when it comes to chemistry-based drugs, which would be of special interest to us since our core competencies are more in the arena of biologics. On the clinical development front, Biogen Idec is already working with several CROs and service providers in India. What is your vision for the company in the next two years? We will continue to help patients with our current products and through ongoing clinical trials and new products in development and also gain a more pragmatic and deeper understanding of unmet needs of Indian patients and India market dynamics. We also hope to contribute to the growth and development of India as a global biotechnology player. Shalini Gupta   ]]> <![CDATA[Two decades of PG teaching in biotechnology in India]]> https://biospectrumindia.com/news/95/5902/two-decades-of-pg-teaching-in-biotechnology-in-india.html https://biospectrumindia.com/news/95/5902/two-decades-of-pg-teaching-in-biotechnology-in-india.html Thu, 07 Feb 2008 11:52:00 +0530 New Page 1 Two decades of PG teaching in biotechnology in India Keeping in mind the demand for trained manpower in specific areas, the DBT has extended its programs to over 61 universities in general, medical, agricultural, marine, veterinary, industrial and pharmaceutical biotechnology. Realizing the tremendous potential of biotechnology in improving human and animal health, increasing agricultural productivity and providing safe and clean environment, the Indian government started a multi agency, the National Biotechnology Board comprising the University Grants Commission (UGC), Indian Council of Medical Research (ICMR), Council of Scientific & Industrial Research (CSIR) and Department of Science & Technology (DST) way back in 1982. This was subsequently upgraded to a full-fledged Department in 1986 to give much desired impetus to this area. Schedule for admission Issue of application forms and submission of completed forms March Entrance examination May Declaration of results July Whom to contact Dr S Chandrasekaran, co-ordinator (evaluation) Academic, Administrative Building, JNU, New Delhi-110067 OR respective course coordinators. Preference by students JNU, BHU and MKU are the first three choices of students for MSc general biotech course at the time of admission. Similarly, TNAU and GBPUAT are preferred choices of candidates for MSc Ag Biotech. Timely interventions of the Department of Biotechnology (DBT) in creating talent pool, infrastructure for R&D and incentives for industry have led to an unprecedented 35 percent annual growth of biotech industry in last four years. This boom is expected to continue and newer opportunities will be created in the area of clinical research and manufacturing, field testing of GM crops, regulatory affairs such as IPR and biosafety, consultancy for business planning and global collaborations. Well-trained manpower in multi disciplinary and rapidly advancing area of biotechnology is a pre-requisite for meaningful R&D and production. India can take pride in being one of the first few countries in the world to initiate an integrated program of human resource development in biotechnology comprising post graduate teaching programs, short-term training courses for upgrading skills of mid-career scientists, faculty involved in undergraduate and postgraduate teaching, training in leading overseas laboratories in gap areas where expertise does not exist in the country. The DBT took a conscious decision to start only postgraduate teaching programs in biotechnology as it is a highly specialized, laboratory intensive course. Specialization at undergraduate level narrows down future options and laboratory facilities and expertise is often lacking in undergraduate institutions. The postgraduate courses were supported initially in 1985 in six universities jointly with UGC, Indian Council of Agricultural Research (ICAR) and the then Department of Ocean Development as collaborative, inter-departmental and inter-institutional programs. Institutions are selected based on existing expertise, infrastructural facilities such as laboratories, lecture halls, library, R&D grants on competitive funding and nearby institutions engaged in biotechnology R&D. India is a vast country and keeping in mind the demand for trained manpower in specific areas and regional aspirations, these programs have been expanded in over 61 universities in general, medical, agricultural, marine, veterinary, industrial, pharmaceutical biotechnology. New programs in food and nutrition, clinical pharmacology and product development, bioinstruments and biomedical standards, bioenterprise management and financing and regulatory affairs are being contemplated. Grants for specialized infrastructural facilities, laboratory equipment, maintenance grant for equipment and recurring grant for consumables, studentship, books and journals, visiting faculty, travel, contingency, and thesis are provided on the basis of actual number of students admitted. These programs are periodically reviewed by in-house advisory committees, annual meetings of course coordinators of all participating universities as well as joint DBTâ€“UGC HRD task force. As a result of two decades of intensive support by the DBT, the standard of teaching and research in biotechnology and allied areas of life sciences has improved considerably. The success of teaching programs can be judged by expertise of faculty, quality of students admitted, curriculum and placement of students. Selection of students To provide allâ€“India representation, maintain uniformity and ensure selection of quality students, students for MSc general and marine biotechnology in 29 universities, MSc Ag. in eight universities, MVSc. biotechnology in three universities and MTech in two universities are admitted through Common Entrance Test (CET) conducted by JNU at 53 centers all over the country and two overseas centers. Admission to other universities or IITs is made through a joint entrance test conducted by IIT or tests conducted by the respective universities. The courses are very popular and admission procedure is highly stringent as 22,365 students competed for 560 seats of MSc and MTech through JNU CET in 2006-07. Students from all parts of the country appear in CET and selected candidates also reflect true all India representation. Who can apply? Candidates with a Bachelor's degree under 10+2+3 pattern of education in physical, biological, agricultural, veterinary and fishery sciences, pharmacy, engineering/technology, four years BSc (physician assistant course); or medicine (MBBS) or BDS with 55 percent marks can apply. Only those candidates who have passed the qualifying examination in 2006-07 and those who will appear in 2008 will be eligible for JNU CET for admission to MSc/MTech biotechnology in 2008. Students who have passed the qualifying examination prior to 2006 will not be eligible for JNU CET. Admission test Question paper for CET comprises of two parts with multiple choice questions. Part A has questions at 10+2 level from physics, chemistry, mathematics and biology. Each question carries one mark and negative marking of half mark. Part B has questions at bachelor's level requiring thinking and analysis. There are 40 questions from physics, mathematics and biology and 20 from chemistry. The candidates are required to attempt 60 questions of three marks each and one mark is deducted for wrong answer. The question papers are jointly set and evaluated by course coordinators of participating universities Curriculum Model course curricula have been developed by the Department of Biotechnology through a consultative process to maintain uniformity and ensure minimum standard of education. The curriculum revision exercise is undertaken periodically to incorporate latest developments. In the ongoing curriculum revision exercise, a lot of disparity has been noticed in total credits allotted to different courses as well as number of hours per week for each credit by different universities. Credits allotted to a course range from 64 to 166. Time and credits for theory differ from 12-20 hours per week and 39-88. Similar breakup for practicals is 6-24 hours per week and 17-78. The time and credits allotted to project work varies from six months to one year and 5-26. Efforts are being made to rationalize these disparities. Addition of courses in new areas like nanobiotechnology, stem cell, IPR, genomics and proteomics and optional course on communication skills is being contemplated in the ongoing curriculum revision exercise. Intellectual capital Intellectual capital in the form of faculty resources is the most important input in an academic program. The number and educational background of faculty is a major indicator. Support to teaching programs has helped in creation of extremely talented 350 faculty members. The details of permanent core faculty and their area of specialization can be accessed at www.dbtindia.nic.in. In the universities conducting postgraduate teaching programs supported by the DBT, the number of core faculty ranges from 1-25. Most of the teaching programs also draw faculty from other departments within the university and nearby institutes. The number of associate faculty varies from 2-21. In many universities, a number of faculty positions are lying vacant. There is provision for inviting visiting faculty to supplement teaching in gap areas. Faculty upgradation programs are conducted in leading national laboratories to keep abreast with latest developments. The faculty has received a large amount of extramural grants on competitive funding basis. During the last five years, the faculty associated with the teaching program from 34 universities have published 1,719 papers in high impact journals. The impact factor of scientific journals 2001 can be accessed from www.genebee.msu.su/journals/1/01/01.html. Details of impact factor are available for 1,151 publications. In addition to faculty from universities who have received sustained financial support for 10-20 years like the IITs (Delhi, Kanpur and Mumbai), All India Institute of Medical Sciences, Madurai Kamraj University, Banaras Hindu University, Aligarh Muslim University, and Devi Ahilya Vishwavidyalaya, some of the new entrants like Jiwaji University, Gwalior, National Brain Research Centre (NBRC), Manesar, Tezpur University and University of Kashmir have also published papers in high impact journals. The faculty have contributed edited books, chapters in books, patents and technologies. As many as 570 students have been awarded PhD degrees in biotechnology related areas under the supervision of faculty members from 50 universities and 567 students are enrolled for PhD at present. Placement analysis The placement of students passing out is an important indicator of success of teaching program. A large number of students coming out of these programs qualify in CSIR-UGC National Entrance Test (NET) for Junior Research Fellowship (JRF), DBT Biotechnology eligibility test (BET) for JRF. Students are pursuing research in leading national and international laboratories e.g. Tata Institute of Fundamental Research, Mumbai, Bhabha Atomic Research Centre, Mumbai, Indian Institute of Science, Bangalore, National Institute of Immunology, New Delhi, Centre for Cellular and Molecular Biology, Hyderabad, JNU, NBRC, International Centre for Genetic Engineering and Biotechnology, New Delhi, National Centre for Cell Science, Pune, National Centre for Biological Sciences, Bangalore, University of Cambridge, UK, National University of Singapore, Singapore, University of Sydney, Australia, John Hopkins University, University of Texas, Purdue University, Carnegie Mellon University, University of Utah, University of Iowa, Michigan State University, Washington State University, USA, Hanover Medical Institute, Dortmund University and Ruhr University, Germany. Several students find placement in companies such as Biocon, Dr Reddy's Laboratories, Shantha Biotech, Panacea, Advanced Enzyme Technology, Bharat Serum, Intas Pharmaceuticals, Serum Institute, US Vitamins, Wockhardt and Zydus Cadila Pharmaceuticals. The analysis of first placement of about 1,000 students passed out during 1985-1995 showed only 12 percent students opted for industry while similar analysis of 2,000 students passed out during 2000-05 indicates a healthy trend of 17 percent students opting for industry. As expected, MSc students opt for PhD and MTech students take up jobs in industries. Due to liberal grants for creation of infrastructural facilities and recurring grants for consumables, thesis, library, studentship and visiting faculty, the programs supported by the DBT offer intensive hands-on training. However, mushrooming of self financing courses without proper expertise and infrastructure has led to large number of disillusioned students unable to find proper placements. In a recent exercise undertaken for assisting postgraduate biotechnology students in finding placement in industry, proposed salaries to be offered ranged from Rs 5,000 to Rs 15,000 per month, which is not commensurate with industry in other sectors for the same level of qualification. Bridging skill gaps The growth in the Indian biotech industry is bound to create requirement for well-trained manpower. However, the industry experts feel that the students produced by Indian universities lack practical skills and the ability to think critically. To reduce the gap between skill sets of students produced by universities and that required by the industry, the DBT is facilitating industrial training of postgraduate students in biotech industries for six months. All students are given a stipend and a bench fee of Rs 50,000 per student is provided to industry to attract them to accommodate more students for training. This training refines the academic knowledge base of students by complementing with practical skills to match the needs and expectations of industry. Industrial training helps over 30 percent students in finding permanent placement. It may be good idea to undertake thesis/dissertation (as part of MSc degree) in industry which could enhance their acceptability by industry. Need to diversify With years of continued support for teaching programs, a number of students with basic biotechnology specialization have been produced in the country. However, there is a need to initiate diversified models of hybrid education such as master of bioscience degree combining business and science in a team based, project focused curriculum to produce flexible, mature and experienced pool of talented students. A number of universities in the US, UK and Australia are running such innovative courses on Masters in Bioscience enterprise. In India, Pune University, Panjab University and Amity University have initiated MBA Biotechnology. These programs are expected to produce students with intensive practical training along with strong background in business, finance, management as well as in-depth understanding of bioscience industry. Dr Suman Govil, adviser & Shubhlata Sharma, senior scientific officer, Department of Biotechnology, Ministry of Science & Technology, New Delhi. The authors express heartfelt thanks to the course coordinators of participating universities for providing details of faculty, student admission and placement. The data covered in the article is illustrative and not exhaustive. Note: The views expressed in this article are those of the authors and not necessarily of the organization to which they belong.     ]]> <![CDATA[BioSpectrum Biotech Schools Survey 2008 (Part-2)]]> https://biospectrumindia.com/news/95/2134/biospectrum-biotech-schools-survey-2008-part-2.html https://biospectrumindia.com/news/95/2134/biospectrum-biotech-schools-survey-2008-part-2.html Thu, 07 Feb 2008 11:24:00 +0530 New Page 1 Sastra University, Tamil Nadu, emerges as the top ranked private biotech institution in the country for the 2006-07 academic year. It is followed by SRM University, Chennai, Jaypee University of Information Technology, Solan, Jaypee Instiute of Information Technology, Noida, and Amity Institute of Biotechnology, Amity University, Noida. Sastra University which participated for the first time in the survey has been the top scorer on the infrastructure score. BioSpectrum Biotech Schools Survey 2008 (Part-2) New Page 2 Methodology The fourth BioSpectrum Top Biotech Schools study includes information pertaining to BTech, Masters and PhD courses but not of BSc courses. This study was conducted during November-December 2007. To maintain objectivity and avoid biases in ranking the institutes, BioSpectrum based its methodology on measurable and quantifiable data. As a result, the research team did not seek perceptions and opinions of stakeholders such as students or industry to rank the institutes. The BioSpectrum team sent questionnaires to over 200 public and private institutes and followed up with them. We received over 30 questionnaires from the private institutes and an equal number from the private institutes. Step - I: Identification of parameters for ranking of the institutes Like the previous years' studies, the parameters suitable for ranking of the institutes were identified in consultation with experts from the industry, education and R&D. Suitability of a parameter was decided after telephonic discussion with 15 experts. From the discussion it emerged that faculty, industry interface, infrastructure and placements were the most important parameters on which the institutes should be ranked. These parameters have been used for ranking of the institutes this year as well. Step - II: Importance ranking of the parameters A structured questionnaire was used to take the opinion of 15 experts on relative importance of the four parameters prior to the study. Their opinion was taken into consideration to decide on weights to be assigned to each parameter. The following means emerged based on data received from experts: Faculty and infrastructure emerged as the two most important parameters ahead of placement and industry interaction. These two parameters get nearly two third importance in the overall ranking. In the present study also these weights have been applied to parameter scores of an institute to arrive at the final score. Step - III: Data collection, analysis and ranking of the institutes A pre-tested structured questionnaire was sent to directors/principals/deans of biotech institutes by the BioSpectrum team. BioSpectrum scrutinized and validated the responses given by the institutes for accuracy, consistency and sufficiency of the data, data entry, analysis of the data and ranking of the institutes. The research team spent considerable amount of time accurately analyzing the filled in data for each institute. For each institute, a score was arrived at for each parameter. For a particular parameter, the score was a composition of each of the sub-parameters. Faculty score of an institute would be composed of faculty per student, qualification of faculty members, research articles published, contribution of the faculty to national and international journals, patents filed and granted. Infrastructure score would be similarly composed of capital expenditure on lab equipment and consumables, expenditure on books and journals, and availability of dedicated and shared PCs per student. Similar scores were arrived at for industry interaction and placement using sub-parameters. Appropriate and largely consistent weights were used for sub-parameters wherever necessary. To give an example, faculty members with PhDs and above were given a higher weight than non-PhDs to arrive at the qualification score. Similarly, publications in international journals were given a higher weight than publications in national journals. More recent publishing of papers, or more recent patents filed/ granted have been given higher weights during analysis. Sub-parameter scores were indexed with hundred points being granted to the institute with highest score for a particular sub-parameter. Indexed scores were than added up for each institute to arrive at the total score for a particular parameter. Scores were then averaged on hundred. Each of the parameters (faculty, infrastructure, industry interaction, and placements) was further weighed as per weights provided by experts to arrive at the total score of an institute. The institutes were then ranked as per this score on an overall basis. The ranking was done separately for public and private institutes. School of Chemical and Biotechnology, Sastra University, Thanjavur, which is the top ranked institute in the list of private BT schools in 2008, was established in 1994. It offers undergraduate programs in bioengineering, bioinformatics, biotechnology and chemical engineering and postgraduate programs in bioinformatics, chemical engineering and industrial biotechnology, besides PhD programs. The institute has also started medical and nanotechnology programs. The department has a total of 91 faculty members and on an average has 39 publications in national journals and 115 publications in international journals between 2003-07. "The excellent infrastructure coupled with an industry-oriented curriculum and expert faculty is reflected in the research output in the form of patents and publications and success rates of the students" says Dr Swaminathan. The placement record of the students is greater than 90 percent and many students are pursuing research in premier research institutions across the world. The department has externally funded research projects worth Rs 1,212.12 lakh from the government in various areas of biotechnology and industry sponsored projects worth Rs 75 lakh. The department of biotechnology, SRM University, Chennai, has fared very high on the industry interaction score (Rank 2). The school offers BTech biotechnology, PG in biotechnology and PhD programs. The full time faculty strength of the department is 76 and 28 faculty members have over five years of experience and are PhDs. The institute had a total cash inflow of Rs 1.82 lakh from royalties for the year 2006-07. The department has 17 independent laboratories, equipped with state-of-the-art equipment for microbiology and immunology, biochemistry, molecular biology, and genetic engineering, plant cell and tissue culture, animal cell culture, bioprocess technology and downstream processing. The Department works with other departments, national and international industries and R&D institutions to develop expertise in molecular biology, metabolic engineering, protein engineering, immunology, biotransformations, biodegradation, plant biotechnology, animal biotechnology, marine biotechnology, enzyme technology, bioseparations, biosensors, bioprocess engineering, pharmaceutical biotechnology and many other fields. The Department has a record of sorts when it comes to linking up with the industry; in terms of student projects and training with highly recognized institutes/industries like Biocon, Shantha Biotechnics, Reliance Life Sciences, Central Leather Research Institute, Cancer Research Institute, Tuberculosis Research Center, Dr Reddy's Lab and many others. The department of biotechnology and bioinformatics of Jaypee University of Information Technology, Solan, was established in 2002 and it has been offering UG and PG degrees such as BTech in biotechnology and in bioinformatics, MTech dual degree in biotechnology and PhD in biotechnology and bioinformatics. The institute figures within the top two ranks on the industry interaction (Rank 1) and infrastructure (Rank 2) scores. The department has six specialized laboratories--proteomics lab, genomic technologies lab, plant biotechnology, microbial biotechnology, animal cell culture, and environmental biotech lab. The faculty is guiding 15 SRFs/JRFs for PhD degrees in Biotechnology and Bioinformatics. The Department has externally funded research projects worth Rs 2 crore from the DST, DBT, and DRDO on various aspects of biotechnology and bioinformatics. The Department has organized two AICTE sponsored workshops for dissemination of biotechnological and bioinformatics skills to the students and researchers in India. Jaypee Institute of Information Technology, Noida, is the fourth-ranked institute based on this year's survey. The institute offers an undergraduate BTech program in biotechnology, BTech-MTech dual degree and PhD in biotechnology. The biotechnology laboratory designed by Canadian architect Arcorp has a laboratory space of 9,000 sft. The institute has labs for biochemistry, animal tissue culture, plant tissue culture, microbiology and instrumentation. The institute's Learning Resource Centre (LRC) has around 24,050 volumes of books and more than 4,000 e-journals. The LRC is a member of Indian National Digital Library in Engineering, Sciences and Technology and All India Council of Technical Education (INDEST- AICTE) and has been subscribing IEEE, ACM, Springer Link and LNCS digital libraries. The department has 15 full time faculty members and on an average has 41 national publications and 81 international publications. The department has three Indian patents to its credit. The department has made an investment of Rs 121 lakh on books, journals, lab equipment and consumables for the year 2006-07. It ranked third on the industry-interaction score too. The Amity Institute of Biotechnology (AIB), located in Noida, is the fifth-ranked institute. Established in August 2001, AIB provides a range of courses in the biotech arena like BTech Biotechnology, BTech Bioinformatics, Integrated MTech Biotechnology, Integrated MSc Biotechnology, PG Diploma in Bioinformatics, MBA Biotechnology, MSc Biotechnology and MSc Bioinformatics courses. AIB has good infrastructure in terms of laboratories for plant and animal tissue culture, microbiology, central instrumentation facility, computational biology, biochemical techniques and molecular biology. Its investment on books, journals, equipment and reagents is close to Rs 240 lakh for the year 2006-07 and AIB is the top institute on the faculty score. It has 103 faculty members.The institute also has a strategic collaboration in the area of business incubation with Embreonix at University of Abertay, Dundee, Scotland for contract research and subsequent commercialization activities in biotechnology. Bangalore-based The Oxford College of Science is ranked sixth in this year's survey of the private institutes. The department of biotechnology at Oxford is headed by Dr Vedamurthy and offers BSc, MSc and MPhil in biotechnology. The courses are affiliated to Bangalore University and recognized by the Government of Karnataka. The course provides comprehensive training in application of biotechnological skills to produce goods and services required by the society and industry. The department has 10 labs dedicated to the biotech students. It is top ranked institute on the placement score. "Out of 40 students, 37 have got placements. We spent close to Rs 82.25 lakh on lab equipment, consumables, and books in 2006-07," said Prof. Veda Murthy of the institute. The institute also figures among the top five (Rank 4) on the infrastructure score and the highest in placement. The department of biotechnology, RV College of Engineering, Bangalore, established in 2003 offers BE in biotechnology as an interdisciplinary course. The department moved into a new building in 2005. The department, which has faculty strength of nine, is headed by Prof. Pushpa Agrawal. RV College ranks second on the faculty score. Though the institute is not on the top in terms of the qualification and experience indices, RV College score high on the patents and publication matrix. Its infrastructure facilities are spread over an area of 2,044 sft and the institute has 12 labs dedicated to biotech students. The total intake for this course is 58. The department has a total value of Rs 18 lakh from industry sponsored projects and Rs 30 lakh from government sponsored projects. Shoolini Institute of Life Sciences and Business Management (SILB) has been established under the aegis of a non-profitable organization, Foundation for Life Sciences and Business Management, and affiliated to HP University, Shimla. The institute has one international patent to its credit. The faculty of the institute is internationally renowned with vast experience in formulating and handling biotechnology related national and international projects, under the overall guidance of Prof. PK Khosla, former vice chancellor, HPAU, Palampur and ex-advisor, biotechnology, Government of Himachal Pradesh. SILB has several collaborations with the industry and academics like the Seoul National University, South Korea, for promoting outsource of biotechnology related research and business. SILB has been accorded recognition as research organization by DSIRO. The department has Rs 30 lakh worth of sponsored projects from the industry and the government. Special emphasis is laid on the career development of the students and its students have found jobs in the industry, research and academics. Rajkot-based Shri M&N Virani Science College, through its department of biotechnology, has been offering biotechnology courses the UG level since 1999. It is believed to be the only college in Gujarat that has been awarded UGC assistance for MSc biotechnology under the Xth Innovative Teaching and Research Program scheme in interdisciplinary and emerging areas in June 2004. The department is run by Shri M&N Virani Science College and is managed by Sarvodaya Kelavani Samaj (SKS). The department has 27 full time faculty and 19 of them are PhDs. M&N Virani Science College has nine well-equipped labs. The departmental library expenditure is nearly Rs 3 lakh per annum. "The post graduate students of the department have found placements in companies like Cipla, Intas Pharmaceuticals, and Reliance Life Sciences," said Dr Shivani Patel, HOD. The institute ranks fourth on the placement score. PES Institute of Technology, Bangalore, started its BE in biotechnology course in 2002. The department of biotechnology at PES is headed by Dr Maulishree Agrahari and is in TechPark building of PESIT. "The faculty at the department are qualified and experienced with most of them having publications in both national and international journals" said Dr Maulishree Agrahari. It has 14 faculty members. The institute has government sponsored projects worth Rs 40 lakh in hand. It ranked second on the placement score and sixth on the industry interaction measure. "We at PES had set ourselves the target of being one of the top ten BT schools in India, a year ago. Knowing that we have achieved our target is a proud moment for us," commented Dr Maulishree Agrahari. ]]> <![CDATA[SBIRI supports 35 projects]]> https://biospectrumindia.com/news/95/5835/sbiri-supports-35-projects.html https://biospectrumindia.com/news/95/5835/sbiri-supports-35-projects.html Thu, 07 Feb 2008 11:20:00 +0530 New Page 1 SBIRI supports 35 projects The SBIRI opened new ways for early stage funding to private industries for high risk, innovative and commercializeable product proposals. This unique scheme, as it expands in scope and coverage will provide a boost for the biotech sector According to the latest Credit Suisse report, India is the latest entrant to the $1 trillion economy club of 12 nations. The Indian economy growing at close to 9 percent for the past four years has signified the growth of a number of sectors and biotechnology is one of them. The Department of Biotechnology (DBT) views its role as a general enabler in the development of biotechnology. The department is committed to support the fledgling Indian biotech industry to have well-structured enabling mechanisms put in place, promote innovation and ensure translation of knowledge to products and processes which can be effectively commercialized. Together, the industry, academia and the government will have to ensure the growth of the biotech industry. "Small Business Innovation Research Initiative (SBIRI)" is one of the steps towards supporting the Indian biotech industry. The launch of the SBIRI in September 2005 opened new ways for early stage funding to private industries for high risk, innovative and commercializeable product proposals. This unique scheme, as it expands in scope and coverage, will provide a boost for the biotech sector. The future challenge is to enable the Small and Medium Enterprises (SMEs) to generate new ideas, take more risks and support late-stage-development for whatever proof of principle has been generated. The scheme has taken off very well and DBT has received 71 full proposals and 17 concept proposals within the first two months itself. Core content of the scheme The SBIRI supports high risk, innovative pre-proof of concept research and early stage development (phase-I) projects as well as late stage development and commercialization as (phase-II) projects. The process of obtaining proposals and their review is summarized in Fig.1. The Technical Screening Committee (TSC) shortlists the proposals initially, followed by presentations by companies. Final recommendations on the proposals are made by the inter-ministerial high-powered Apex Committee of SBIRI (ACS). The department processes in two batches overlapping with each other in order to reduce the processing time considerably. The proposals can be made by an industry alone or jointly by an industry with public partner(s) or by a group of industries with or without public laboratories. To be eligible to seek funding under the scheme, an industry registered in India should be a small business unit having not more than 500 employees in R&D with at least 51 percent shares owned by Indians or independently operated. The R&D unit of the company should be recognized by DSIR or the company should own the patent rights on the work done which would be utilized in the proposed study. The outline of the funding structure for Phase-I and Phase-II type of projects is given in Fig. 2. Response of biotech industry The scheme has been advertised six times till the end of 2007. In the first two batches, the response from the industries was very encouraging. Thereafter, the inflow of proposals was somewhat lesser. The response of the industry during the sixth batch is substantially improved. In six batches, a total of 361 proposals have been received by the department (Fig.3). The distribution by sectors is as follows: health sector (36 percent), industrial product and process development (22 percent), agriculture and allied areas (20 percent), instrumentation and devices (11 percent), food biotechnology (4 percent), bioinformatics (4 percent) and environmental biotechnology (3 percent) (Fig. 4). Of the 361 proposals, 270 (75 percent) are for early stage research categorized as Phase-I study and 73 (20 percent) are for scale up and late development of research leads in Phase-II category. A few proposals (5 percent) are a combination of the two (Fig. 5). The trend indicates that the industry is seeking support under SBIRI mostly for early phase research, which is the main purpose of the scheme. Out of 361 proposals received by the department, 142 are collaborative proposals indicating that the process for generating ideas by bringing users and producers of technology together has been strengthened through SBIRI. A total of 237 companies have approached the department for SBIRI support. The companies from 18 states/union territories have shown interest in the scheme. Among them, Karnataka, Maharashtra, Andhra Pradesh, Tamil Nadu and Delhi are top five hubs for SBIRI applicants (Fig.6). The response from the industry in the southern region is predominant (Fig.7). City-wise analysis indicates that the research intensive biotech industry is currently concentrated in five major clusters -Bangalore-Mysore, Hyderabad-Secunderabad, Mumbai-Pune-Thane, Chennai and Delhi (Fig. 8). Status as on January 31, 2008 The scheme was launched in September 2005. Actual sanction of the projects started in the end of December 2006. In a short span of 13 months, 35 projects worth Rs 142 crore have been supported. The details are indicated in Fig.10. The private sector has committed investment of around 48 percent of the total. The remaining would be from SBIRI funds of the government. Out of the 35 approved projects, 15 are in the health sector, nine are for industrial products and process development, seven are in agriculture and allied areas and four are in the area of bioinstrumentation and devices. Twenty out of 35 are Phase I projects. The department has released a sum of Rs 39.47 crore to the respective companies so far for implementation of the projects. The Project Monitoring Committees (PMCs) have been constituted for each funded project separately. Processes for idea generation The government of India has supported research and development efforts in the country through national laboratories and other public funded scientific & industrial research organizations. But the conversion of knowledge to commercial products has not been adequate. Many technological concepts, solutions, techniques are languishing at the laboratory level without further development. Inventors get few opportunities of scaling them up for commercialization. The skills required for the translation and commercial product development are weak in the public sector. Technology transfers and IP skills in public sector need to be strengthened. More steps are needed to build up strong industry academia interface. New modalities need to be worked out to generate innovative ideas in different spheres of biotechnology. Venture Capital (VC) is the ideal approach to innovation. An enabling environment has to be created to attract VC. Biotechnology is a high risk area. Public support for innovation through schemes such as SBIRI, NMITLI and TDB for commercialization together covers the innovation chair. There are several future challenges for SBIRI. The DBT needs to further professionalize project evaluation and management and we are committed to do so. The density of scientists in biotech SMEs needs to be increased by having high quality people. SBIRI must create processes for idea generation and in this regard two initiatives are planned this year. First, industry partnership platform will be launched to define research agenda by private sector for public support, in collaboration with FICCI. Biotechnology Industry Research Assistance Council (BIRAC), a new organization will be established to manage public funded industry R&D. BIRAC will also organize science and technology meetings for SMEs. Since, SBIRI is limited to companies in small and medium sector, a new R&D scheme will be initiated by the DBT for large industry. Overall, the DBT's efforts to support innovation in biotech industry have commenced, and will be scaled during the next two years. The industry in turn must develop its R&D, and undertake high risk, high reward type projects. The DBT and industry have to work together to create world class management and evaluation process. We believe Indian biotechnology is headed for major increase in innovation activities. Suchita Ninawe Department of Biotechnology, Delhi   ]]> <![CDATA[IP to Market Place, Avesthagen Shows the Way]]> https://biospectrumindia.com/news/95/1912/ip-to-market-place-avesthagen-shows-the-way.html https://biospectrumindia.com/news/95/1912/ip-to-market-place-avesthagen-shows-the-way.html Thu, 07 Feb 2008 10:50:00 +0530 New Page 1 IP to Market Place, Avesthagen Shows the Way With a pipeline of over 160 patents in about seven years, Avesthagen is on the threshold of unleashing 15-20 products in the next two years. Over the past few months, Avesthagen has been making several major announcements. These announcements indicate that Avesthagen is bracing itself for its initial public offering (IPO). In January 2008 alone, there were two major announcements. One, Avestha Gengraine Technologies becomes Avesthagen Limited. The announcement that Avesthagen has become a limited company, following an approval from the Registrar of Companies, is a step towards broadening of its corporate legal status and bringing in stringent corporate governance. "It also brings transparency in all our operations and the opportunity for future public participation in wealth creation. A public limited status will also help us to rope in public and institutional investments for future expansion needs," said Dr Villoo Morawala-Patell, Founder & CMD, Avesthagen Limited, and the BioSpectrum Entrepreneur of the Year in 2006. The other announcement that Avesthagen made was that it has put into pipeline some of its key patents. This is a very significant achievement for a company, which began its formal business operation in 2001 as an innovation model. Though it is difficult to substantiate its achievement on a comparative ground, the gut feeling is that Avesthagen's achievements are not only unique but also an enviable feat. Patents journey The organization started on the basis of two patents. "I wanted to start an organization that was unique and would bridge academia and the industry. Initially, it was to be a Public-Private type of initiative. I wanted the organization to be anchored on an innovation platform and have a strong patent portfolio," Dr Villoo explained. So around mid-1998, she registered Avesthagen as a not-for-profit organization and Avestha Gengraine Technologies as a company for commercial purpose. The idea was to drive grants into 'Avesthagen' and then spin out technologies that could be commercialized into the private entity 'Avestha Gengraine'. At that time, the academia (public institutions) did not treat patents as a priority and the venture capitalists (private) were apprehensive about the public-private model. In other words, neither of the sides was ready to accept the other. Avesthagen was thus born in a conflicting environment. At that time, Dr Villoo was trying to get the rice genome project to India and though she could convince Japan to allocate the chromosome to India, she was not able to get the funding. She realized that this was not working out. This was in September 1999 and she decided to detach from this model and become a private company. Two agriculture technologies were the cornerstone patents to achieve this. One was from Dr Villoo's work from the Rockefeller fellowship which was basically to engineer rice for drought tolerance. The other used RNA editing to induce male sterility in plants to enable production of hybrids. "Then I filed for a third patent which was for millet transformation. These were provisional patents that cost about Rs 1,500 each" said Dr Villoo. She was working then between the campuses of NCBS and UAS in Bangalore and decided to work from a rented place in Sahakar Nagar in Bangalore. "From September 1999 to November 2000, we operated there and the business plan was based on these patents and my goal was to create an India-based global entity on the pillars of India's biodiversity, cutting edge science and convergence of food and pharma," said Dr Villoo. The mantra was "Seed for Food", "Food for Medicine", R&D services and partnering. Avestha Gengraine Technologies absorbed Avesthagen as a brand that is committed to socio-economic equality, according to Dr Villoo. Patent filing system and process at Avesthagen Intellectual property has gradually become a core component of the long-term strategy of the company. "Avesthagen is proactively pursuing patent protection for its innovations and is looking at building a large patent portfolio which provides sufficient coverage to practice a technology along with sufficient defense and a good offensive position regarding the product, in order to provide a competitive advantage in an environment where battle lines are readily drawn. The essence of Avesthagen's research and development philosophy lies in building and strengthening the patent portfolio," said Dr Villoo. Avesthagen addresses the limitations of the typical IP chain by treating IP as a manageable asset and by incorporating it into the business planning process, much like any other business process. The result is a fully integrated IP value chain that has succeeded in aiding the company in building a targeted portfolio of IP, which also supports its business objectives. A comprehensive business strategy has been evolved by Avesthagen that guides and directs the IP value chain. The patent portfolio of Avesthagen encompasses the four major strategic business units namely BioPharma, BioNutrition, BioAgriculture and Science & Innovation largely covering the inventions related to Metabolomics, Molecular Markers, Novel protein and Gene sequences, Biotherapeutics, Bioinformatics, Microbial Genetics, Novel protocols and Processes and formulations. The IP team is involved at every stage of the research and development process to enable the development of truly novel technologies for global markets and ensures that the R&D activities conducted in these business units are fully protected by means of patents. "By means of competitive IP intelligence, we assess the technology and patent landscape associated with the current and future products/technologies. The knowledge of this relevant patent landscape provides a sustainable competitive advantage for developing and executing core business strategies," said Dr Villoo. Hence, by studying the patent landscape Avesthagen avoids the pitfalls of forging into a heavily patented area, if it chooses to work in a competitive arena. In addition, the patent literature available provides insight into the priorities and strategies of competitors, and point to potential acquirers, licensors of technology and gaining an insight into the scientific trends and developments. After having established a competitive IP landscape, the next step is to develop an IP roadmap--a step-by-step plan that outlines the finer details of the IP strategy and directs decisions about IP investment. The map points to inventors to the areas where they should innovate and the legal team to what is patentable. The main step-by-step patenting process in Avesthagen includes conception, primary documentation, capture, initial review, formal documentation, formal review, legal documentation, and patent prosecution by a team specially constituted for the purpose. The team varies according to the nature of the invention. External support comes in the shape of law firms who handle the patent application on behalf of the company. "Inventors are intimately involved with the fine details of the technical steps leading to their invention, and hence they often find it difficult to discern between their inventions and prior art. The patent team in Avesthagen clears this hurdle by scrutinizing their laboratory books every week and then targets areas of potential interest," said Dr Villoo. IP to business The mantra was to create technologies and make deals. Avesthagen anchored the "Food for Medicine" strategy working in the area of Indian medicinal plants and developing systems and tools for analysis of medicinal plants. Following a systems biology approach, it developed AdePt, a comprehensive database of medicinal plants linked to disease conditions. The second was MetaGrid, which is an algorithm that links metabolites to efficacy at the cell assay level. "These were the cornerstones. They were patented and trademarked. We used these two technologies to partner with companies," said Dr Villoo. In agriculture, Avesthagen created a number of lines of rice amongst other things and entered into an alliance with Limagrain, France. Similarly, it did work on tuberculosis, which lead to the deal with Biomerieux. It signed a deal with Cipla based on its core expertise in recombinant DNA technologies. "In each of these cases, there was a core patent linked to a technology and fencing patent to protect the technology. Then there were certain interesting bits of patents filed for supporting the future opportunities," added Dr Villoo. "If you look at our entire patent portfolio, there would be around 25 core patents across all life sciences (food, pharma, agri, and diagnostics). The rest are in two categories--fencing patents and ideator patents." Patents to products Avesthagen spends a significant amount of its budget on R&D. Almost 60 percent of that would be on R&D cost and the remaining would be on partnering work. Avesthagen has raised about â‚¬45 million and most of the money has gone in building the R&D infrastructure. Several products that have been developed by Avesthagen are expected to hit the markets shortly. About 14 products will come out of its preventive healthcare portfolio. The seed is three years away from hitting the market. "We have entered into the manufacturing phase. In agriculture, we acquired two seed companies. We have the germplasm and the IP will be plugged in. In the case of bioactives, we have acquired an American company, which has world-class manufacturing in India. In pharma, we are building manufacturing capabilities through the joint venture with Cipla. In diagnostics, our TB diagnostics initiative is ready and we are finding the right partners to put the technology," explained Dr Villoo. The marker-selected seed will come out within a year or two. Avesthagen is not using the word GMO. It calls them Environment Adjusted Crops and that has also been trademarked by Avesthagen. Future Plans Avesthagen is now in the phase of product development and will continue to do so in the future too. "Avesthagen is a juggernaut of innovation that will never cease to churn out novels ideas and products," said Dr Villoo. The next phase of Avesthagen will address predictive, preventive, and personalized medicine in a more defined manner. It has launched four new projects in this direction. What started in 2001 (in about seven years) will result in about a portfolio of about 25 products (by 2008-09). "I realize that to remain at the forefront, we have to keep innovating so that we have a continuous stream of products making it to the market," emphasized Dr Villoo. The four projects-Avesthagenome, drug discovery, stem cell, and environment-adjusted crops-will help in release of newer products. The company is focused on partnering to achieve a broad spectrum play leading to convergence of food, pharma and population genetics across the life-science space. Avesthagen is moving towards achieving a "Predictive Preventive Personalized Healthcare" model through its four strategic business units--BioPharmaceuticals, BioNutrition, BioAgri and Science & Innovation. The company's partners include several top 10 global companies in each of its fields of research. Ch. Srinivas Rao   ]]> <![CDATA[Indian analytical instrument manufacturing industry on a high]]> https://biospectrumindia.com/news/95/3873/indian-analytical-instrument-manufacturing-industry-on-a-high.html https://biospectrumindia.com/news/95/3873/indian-analytical-instrument-manufacturing-industry-on-a-high.html Wed, 09 Jan 2008 11:29:00 +0530 New Page 1 Indian analytical instrument manufacturing industry on a high Ramesh Datla managing director, ELICO Limited, Hyderabad The Indian instrumentation market including consumables and spares is estimated around $1 billion, with an annual growth rate of above 10 percent The foundation for indigenous analytical instrument manufacturing industry was laid with the establishment of ELICO by DVS Raju in 1960 in Hyderabad. ELICO developed and introduced the first indigenous pH meter. Others companies such as Toshniwal Instruments (Chemito) by Arun Toshniwal in 1961, Systronics by Dr Vikram Sarabhai and AIMIL by HC Verma in 1965, ECIL a public sector enterprise by Dr AS Rao in 1967 followed suit and entered the arena of instrument manufacturing. The Seventies and Eighties witnessed the entry of CIC, Nucon, Netel, EI, Lab India, Transasia and Premier Color. A large number of small companies were started in late Eighties and Nineties producing low end products addressing regional markets. Eighties saw a major part of the instrument industry moved into trading and representing foreign manufacturers, except for a few. However, as Indian economy grew since the 1990s fueled by the economic liberation policies of the government, and rapid globalization of the Indian economy, the market opportunity became visible to the global players. Pharmaceuticals, life sciences, petroleum, mines and minerals, metals, and food and beverages were few of the distinct sectors that achieved global scales, and required to adopt best practices for research and quality. This resulted in a shift in strategy for the global players who had a reasonable representation of their products to establish their own subsidiaries for not only providing sales and support but to offer value add services like application support to the various verticals. Technology isolation in India In the 1960s, a lot of work went into the development of analytical instrumentation mainly in the Department of Atomic Energy (DAE) and Council of Scientific and Industrial Research (CSIR) labs that were funded by the government. This was because of the technology isolation faced by India after the Chinese war and the "self reliance" objective thus set by the government. Very few of the instrument technologies thus developed were ever commercialized. Later, dependence on foreign products grew because of non-availability of indigenous technologies. Most of the Indian instrument companies though initially started developing indigenous technologies, could not keep pace with technological advancements, as the support structure did not evolve. Hence they opted for technical tie-ups except for a couple of companies who continued to invest in in-house R&D. Products manufactured in India The products manufactured in India are in the following technology areas: Apart from these products, application specific products like clinical chemistry analyzers, color analyzers, micro plate readers, milk analyzers and consumables like chemicals, reagents, enzymes, chromatography columns are also manufactured. The technologies discussed have been indigenously developed and successfully compete with imports addressing the low and mid range markets. Some of these products are being exported worldwide. A couple of the Indian companies have moved into high end product development and are also working with global players in co-development and manufacturing. Deterrents for industry collaboration and innovation The instrument industry is technology intensive involving several disciplines of technology which include optics, fluidics, mechanics, precision engineering, materials, electronics (hardware and software), sensors, detectors, chemicals, product engineering and above all competent human resource. Backward and forward integration is very essential for any industry to grow and non-existence of this structure was a deterrent for the growth of Indian instrument industry. Comparatively in the western world the R&D has been extensively driven by defense and space programs initially and later supplemented by funding for agriculture and medicine. Preference was given for locally produced products for many years. Governments funded heavily on research programs that integrated government, academia and industrial research in a closed loop program under their respective national technology plans. This resulted in establishing centers of excellence and extensive generation of IPRs and the outcome was that the industries became globally competitive due to technological superiority. Similarly, India too has a well established science and technology infrastructure under the CSIR, DAE, DoS and DRDO institutions and world-class academic institutions like IIT and IISc. Though a lot of funding went into these institutions the drawback was the poor interface between the industry, research institutions and academia because of lack of an integrated national instrument development program for indigenous instrument development. Very few of the technologies ever developed had commercial relevance. However, the scenario is changing and we see an increased participation among the stakeholders. Market demographics For many years until liberalization in the 1990s, the government which included academia was the largest buyer and was driven more by budgets structured in the five year plans rather than a necessity. Market demographics post WTO In the 1990s with opening up of the economy, the country saw rapid economic growth coupled with freeing the market of all trade barriers. In 1998 India became the signatory to the WTO-IT agreement by which the duties on most of the analytical instruments had to come down to zero by 2005. The WTO regime opened up Indian market for all types of products. The Indian instrument industry started facing stiffer competition, particularly on technology and cost. With trade barriers coming down licensing of technology became tougher and IPR has become the key for survival and growth. Worldwide the analytical instrument industry is estimated at $32 billion with top 10 companies having 50 percent of the worldwide revenues and the top 50 accounting for 70 percent of the global revenue. Consumables, spares and maintenance also form a large share of these revenues and are the most profitable. The Indian analytical instrument market including consumables and spares is estimated around $1 billion, with an annual growth rate of above 10 percent. It is estimated that this growth rate will continue for the coming years. About 85 percent of the market is dominated by global players mainly from the US and Japan followed by European manufacturers and the rest by local players who are focused on low and mid end of the market. Trends The users perspective "Can we have an instrument or a group of instruments which can talk to each other and give the required result as fast as possible; and an instrument company which can provide an end to end solution?" Due to competitive pressures time and productivity are the biggest challenges in the laboratory today. A one stop shop which provides automation and networking of instruments leading to speed of analysis, meeting regulatory compliance and support has become the key for the customer. Instrument technologies are by and large driven by the life science industry which requires products and technologies that address their dynamic needs for new drug discovery and regulatory compliance. Opportunities for India Globally the largest segments are the separation science and spectroscopy techniques. This pattern is similar in India also. The highest growth rate has been in the life science sector, which includes pharma, bio, proteinomics, genomics and clinical research related instrumentation. In India the government and academia are still the largest buyer of analytical instruments, followed by the research and pharmaceutical industry. As the Indian GDP continues to grow at an average rate of 8 to 9 percent the demand for analytical instruments will continue to grow and eventually industry and research will become the largest buyers of analytical instruments. Increased security concerns in India are leading to huge investments in laboratory instrumentation for forensic and explosive detections. Stringent hygiene standards are leading to increased investments in instruments for food and beverages and water analysis. The instrument industry being multidisciplinary and driven by industry/application specific requirements requires manpower with technical skills. As India has a large pool of technical manpower it will give an edge for India-based industry. The rapid economic growth and the competitive environment thus created coupled with stringent government regulations are forcing Indian industry to have world-class laboratory infrastructure. This environment is creating a huge opportunity for the instrument industry. In the last few years a large number of foreign companies from various sectors have set up their R&D facilities in India with world-class laboratories. Growing opportunities in the Indian market space has made few large global instrument companies to look at establishing R&D and manufacturing base in India not only to cater to Indian market but also to the entire Asian markets which is now the highest growth market for analytical instrument industry. Partnership mantra The rapid economic growth in India has created a huge market coupled with a large pool of technically qualified human resource. This environment is making India an attractive base for R&D and manufacturing. Since the last decade a large number of foreign companies from various sectors have setup world-class R&D and manufacturing facilities in India for catering to the local as well as global requirements. This has created an ecosystem, which has enabled a competitive environment to flourish. The huge competitive market thus created is forcing Indian instrument industry to become world class by aligning with global standards in technology and applications. This requires investing heavily in R&D leading to innovation and IPR generation. In this scenario the growth for the instrument industry will be in offering application specific, highly sensitive, intelligently networked instruments producing fast and accurate results and meeting regulatory compliances. To achieve this M&A, partnerships with research institutions or other instrument companies has become the order of the day. In the coming years we will be seeing a new breed of IPR driven instrument companies emerging.   ]]> <![CDATA[Innovative vacuum solutions in pharma industry]]> https://biospectrumindia.com/news/95/2840/innovative-vacuum-solutions-in-pharma-industry.html https://biospectrumindia.com/news/95/2840/innovative-vacuum-solutions-in-pharma-industry.html Wed, 09 Jan 2008 11:11:00 +0530 New Page 1 Innovative vacuum solutions in pharma industry Vacuum pumps and systems are common across a tremendous range of industries. Once the essential principles are understood, the possibilities for application become apparent. In order to properly select a vacuum system, the principles of basic vacuum technology should be understood. Once the application is clearly defined, a solution can be found by applying these methods. Since we understand and can relate to atmospheric pressure, it is chosen as a reference point. Vacuum is simply a pressure that exists below atmospheric pressure. To create a vacuum in a vessel, a vacuum producing device needs to remove mass from it. The more mass that is removed, the lower the pressure that exists inside the vessel. This is why it is important to understand what vacuum is and how to select the right type of equipment. It is very important to size vacuum piping correctly to minimize pressure loss. The greater the pressure loss, the larger the vacuum equipment needs to be. The type, quantity of gas handled, and the operating pressure, normally defines what vacuum pump can be used. If the gas consists of mainly non-condensable, then most types of pumps can be used. If the gas consists of non-condensable and condensables, then the choices will be limited. Therefore a right solution considering the load of condensable and ultimate vacuum should be struck. System selection To select the best type of system for a particular application, several parameters need to be considered. They include operating cost, solvent recovery, effect on process, materials of construction, operating range, reliability, waste generation, pollution abatement, emission reduction, maintenance cost, ease of cleaning, serviceability and purchase price. After this the vacuum pump that best meets these criteria may be selected. Pharmaceutical industry The pharmaceutical industries use vacuum for distillation and drying. Various types of dryers are used to purify products under vacuum. The chemicals are precisely mixed and then heat is applied in the dryer to evaporate the excess chemicals. This is done under vacuum for purer end products; reduce the amount of heat energy required for drying, and also to recover any of the solvents evaporated off thereby not affecting thermally sensitive products. Pumps that are reliable and easy to service in the field are the most important for this industry. If an unreliable pump is tried and it fails in the middle of a drying cycle, then the product is not useable and profit is lost. A typical setup used for this application is combining mechanical roots blower along with oil lubricated vacuum pump. This kind of setup is used to minimize utility costs, drying cycle time and contamination. A properly designed process condenser between your vacuum process and vacuum producing system will yield significant advantages. A process vacuum condenser can significantly reduce the size of the vacuum producing system, recover for reuse valuable product carried from your process with non-condensable gases, reduce amount of wastes produced by the vacuum system, and lower the operating cost of your process. Matching a vacuum condenser with the vacuum producing equipment is the best way to meet the objectives of process. Toshniwal manufactures both the process condenser and the vacuum producing equipment. This single-source responsibility provides you with a unitized system matched to the process. Toshniwal Systems & Instruments, Chennai   ]]> <![CDATA["Asia is where the action is"]]> https://biospectrumindia.com/news/95/2619/asia-is-where-the-action-is.html https://biospectrumindia.com/news/95/2619/asia-is-where-the-action-is.html Wed, 09 Jan 2008 11:03:00 +0530 New Page 1 "Asia is where the action is" -Marc N Casper, executive vice-president, ThermoFisher Marc N Casper Dr G Ramakrishnan ThermoFisher Scientific, a company that was formed by the merger of Thermo Electron Corporation and Fisher Scientific International, has moved on from strength to strength and bolstered its Indian operations in an enterprising manner. Dr G Ramakrishnan, managing director of ThermoFisher India and Marc N Casper, executive vice president, ThermoFisher spoke to CyberMedia News weeks after the company celebrated its first anniversary on the November 9, 2007. Excerpts from the interview: You have just celebrated one year of operations. Could you give us the highlights of your journey so far? Marc N Casper: The company has just celebrated its first anniversary on November 9. Thermo Electron Corporation has a long history dating back over hundred years. Our focus as a new company has to become the world leader in serving science to our customers. We are very focused on innovation because we are going to help our customers with our set of products and innovative set of products and focused on bringing new products. What are the technological challenges that Indian markets offer to companies like ThermoFisher? Marc N Casper: From a technology point of view or even if you look at the CRO (Contract Research Organization) scenario point of view-Indian market wants to make sure that it has the best technology because there are global partners around the world-the technology needs to be the same. The challenge is how to get the same level of technology across all the geographies. The best of spectrometers are all present in India now. However, in the coming years the technology that would heavily be utilized would in the infrastructure of laboratory level that is at the basic level where it is still not that high as in other markets. ThermoFisher acquired Qualigens Fine Chemicals which is a division of GlaxoSmithKline Pharmaceuticals Limited in 2007. How strategic was this move from your company's standpoint in the Indian markets? Marc N Casper: The acquisition of Qualigens gives us a very strong presence in India. Because of the importance of having a strong distribution in India, we acquired the company and its 140 employees gives us a much better footprint in the Indian markets. Could you give us instances both from the Indian standpoint and from the global point where your solutions have benefited your patrons? Dr Ramakrishnan: We acquired Massachusetts-based Cohesive Technologies that is a leader in producing liquid chromatography products and advanced sample extraction. That acquisition strengthened our in-line sampling preparation capabilities that could be coupled with mass spectrometric technology to build a stronger workflow solutions for organic molecule and other drug analyses. Marc N Casper: From the global standpoint I would use the mass spectrometry example. We have constantly innovated ourselves in this domain be it with our LTQ XL Linear Ion Trap Mass Spectrometer with ETD (Electron Transfer Dissociation) for proteomics, Accela(TM) High Speed Chromatography System, patented FAIMS Technology for high sensitivity LC/MS/MS quantitation and the TSQ Quantum(TM) Access Triple Quadrupole Mass Spectrometer. These products are employing cutting edge technology and our focus to understand the customers have always made us stand apart. Going forward, where would ThermoFisher concentrate in the coming quarters? Marc Casper: Concentration is firmly on geographically-Asia is clearly where the action is. It's where the innovation is and this is where large customers are present--continuous focus on this market. Prasad Ramasubramanian, CyberMedia News   ]]> <![CDATA[Bigger role for smaller firms]]> https://biospectrumindia.com/news/95/1474/bigger-role-for-smaller-firms.html https://biospectrumindia.com/news/95/1474/bigger-role-for-smaller-firms.html Tue, 08 Jan 2008 16:06:00 +0530 New Page 1 Bigger role for smaller firms Nitin Naik (Nitin Naik is director of healthcare technologies and life sciences consulting practice, Asia Pacific at Frost & Sullivan, Singapore) Small companies will have a greater role to play to bridge the gap in discovery process by reducing time and cost in product development. The global life sciences industry has transitioned to a growth phase, and has started to deliver results. In the second and third quarter of 2007, the life science companies have registered a healthy growth. Business confidence is on the rise amongst life science companies as they have developed a strong product pipeline, which have very good market potential. The industry, it seems, has drawn a long-term strategy to make these products more user-friendly, develop combination therapies to enhance their effectiveness. In the changing scenario, the small companies have a greater role to play to bridge the gap in the discovery process by reducing time and cost in product development. There is a clear indication of growing partnership in terms of mergers and acquisitions across the globe between the big and small companies. The scenario is changing in Asia as well. With the growing economy in the Asian countries, the opportunities are opening up. At the same time the costs and wages are also increasing for skilled and talented work force in a high technology industry such as life sciences. Companies in the west are looking at smaller emerging and developing markets like Malaysia and Thailand for outsourcing activities. These developing markets will take an active participation in the knowledge-intensive life sciences industry. The challenges Factors like long gestation period and no quick returns on investments are still coming in the way of venture capitalists to invest in life sciences companies. The companies need to showcase their unique and niche position with emphasis on product application and commercialization aspects. Trends for pharma industry in 2008 Outsourcing & off-shoring to continue Global licensing Layoffs and lean operations Growing importance and dominance of generic companies Challenging times for wholesalers M&A / consolidation Eliminating hospital infections Prevention of medical errors Emergence of new global players Additional pressure, limelight and scrutiny of US Pharma industry due to elections Source: www.pharmanewsanalysis.com   Technologies that will make a difference During 2008-2010, biologics serving treatment of autoimmune diseases, infectious diseases, and neurological disorders will be in focus. However, this will be possible only through a series of incremental advances, such as the development of targeted therapies that match pharmaceuticals to genetically appropriate patients. ]]> <![CDATA[The year that was!]]> https://biospectrumindia.com/news/95/1156/the-year-that-was.html https://biospectrumindia.com/news/95/1156/the-year-that-was.html Tue, 08 Jan 2008 15:41:00 +0530 New Page 1 The year that was! Year 2007 can easily be classified as the turning point for the life sciences industry. It saw the completion of the second phase of HapMap Project-created to identify and catalog genetic similarities and differences among populations around the world. Scientists from six countries worked on it. The first phase, completed in 2005, provided data that has led to the development of techniques used in the search for genes associated with common diseases. It has also helped in the identification of 50 such disease-associated genes. However, the biggest feat is the "designer genome" brought into existence by famed scientist Dr Craig Venter. Using lab-made chemicals, Dr Venter's team stitched together a chromosome that is 381 genes long and contains 580,000 base pairs of genetic code. This has made artificial life a not-so-distant possibility. Worldwide there were a number of breakthroughs ranging across segments of pharma, biotech and medical technology and a good measure of work happened in APAC countries. While Australian drug discovery company Phylogica focused on finding new Phylomer drugs, the Japanese scientists developed molecular scissors that open and close in response to light and make for a great invention with applications in manipulating genes and other molecules. In Malaysia, scientists developed herbal drug for dengue and scientists in Thailand discovered oral AIDS vaccine while Indian life sciences industry saw the launch of a number of vaccines. In the ensuing pages BioSpectrum brings to you a recap of some of the breakthroughs, technologies, products and people who made news in 2007.   Drug-resistant TB genome sequenced, a small win A breakthrough that will help fight the deadly disease of tuberculosis has been achieved in South Africa. The genome of one strain of an extensively drug-resistant tuberculosis (XDR-TB) has been sequenced there, using technology developed in the United States. "We consider this a breakthrough because it will provide for more analysis of MDR (multi drug-resistant TB) and XDR-TB (extensively drug-resistant TB), and to understand the differences between them," said Dr Carl Montague of LifeLab, a biotechnology project funded by the South African government. Elsewhere in the world, researchers are on way to develop two highly potent shorter-term tuberculosis drugs. Two anti-TB drugs (Moxifloxacin and PA-824) have reached the advanced stages of clinical trial and could be available worldwide by 2012-2014, raising hopes for shorter-duration treatment and fighting the bacterium that has become immune to the present drugs. Developed by TB Alliance, Moxifloxacin has reached the phase III stage of clinical trial and 900 patients were given the drug in the three phase II studies conducted on it. While the second drug, PA-824, has entered the phase II trials and will be now given to TB patients to study its short-term potency.   A big leap for Indian enterprises Year 2007 saw Bharat Biotech International launch BioHib, the first indigenously developed and manufactured Haemophilus Influenza type b (Hib) vaccine in India. It also launched its tetravalent combination vaccine, Comvac4-HB containing Diphtheria, Pertussis, Tetanus and Hepatitis B in one vaccine. These two new vaccines BioHib and Comvac4-HB, enable the deployment of a combination pentavalent vaccine in a single injection. Serum Institute of India launched its indigenously manufactured low-cost Haemophilus influenza type b conjugate vaccine under the brand name of HibPRO in India. HibPRO has been priced at $9 (Rs 360) for a monodose vial. Dr Reddy's Laboratories has launched Reditux, the Dr Reddy's brand of rituximab, a monoclonal antibody (MAb) used in the treatment of Non-Hodgkin's Lymphoma. Talking about monoclonal antibody-based drugs, Biocon's BIOMAb EGFR for treating solid tumors of epithelial origin has extended applications. BIOMAb-EGFR that was launched in September 2006, has in 2007 seen an increase in the total number of registered patients to almost 1,000 in the country. The drug indicated for head and neck cancer is also being studied in global clinical trials for colorectal, lung cancer, glioma (brain cancer), and pancreatic cancers.   Minicells for cancer drug delivery discovered Sydney-based biotechnology company, EnGeneIC, has successfully created the world's first nano-sized particle aimed at providing more effective and efficient drug delivery to cancer cells. The new, patented delivery technology is derived from minicells of bacterial origin and is called EnGeneIC Delivery Vehicles (EDVs). EnGeneIC has achieved results in reducing tumors without toxic side effects in pre-clinical animal models of cancer. The drug delivery technology is applicable for a wide spectrum of cancer types. Two senior Australian scientists, Dr Jennifer MacDiarmid and Dr Himanshu Brahmbhatt, have led the EngeneIC research team. They founded the program in 2001 and are joint managing directors of the company. The researchers claim that for the first time it has been proved that this technology could lead to the use of multi-drug combinations and could eventually help in the development of custom-made therapies for cancer patients.   Bharat Biotech launches thimerosal-free vaccines Bharat Biotech has launched Revac-Bmcf, a thimerosal-free Hepatitis B vaccine. With it, Bharat Biotech joins this elite club of vaccine manufacturers in developing, manufacturing and commercializing thimerosal-free vaccines. Biocon, Abraxis BioScience announce approval of Abraxane Biocon and Abraxis BioScience, an integrated, global biopharmaceutical company, have announced the approval to market Abraxane for Injectable Suspension--paclitaxel protein-bound particles for injectable suspension (albumin-bound)--in India for the treatment of breast cancer. Commercial introduction of Abraxane in the Indian market is expected in 2008 following the completion of the appropriate importation certifications. Eli Lilly launches Byetta Eli Lilly and Company India has launched Byetta (exenatide injection) in India. Byetta is used to improve blood sugar control in patients with Type 2 diabetes. The drug is indicated in combination with metformin and/or sulphonylureas, two common oral diabetes medications. Studies with Byetta found that it not only improved blood sugar control but also resulted in a reduction in body weight. Indian Immunologicals launches nutraceuticals for animals Indian Immunologicals, a wholly owned subsidiary of the National Dairy Development Board (NDDB), has made its foray into the animal feeds segment by launching a range of dairy nutrition products. The products include: Calsagar (an animal feed supplement in pellet form, containing calcium, phosphorus and vitamin D3), for improved milk production, improved fat and SNF content in milk; Garbhamin Bolus (contains essential trace minerals in chelated form and coated vitamins) for superior reproductive performance, and Goumix, the first customized mineral supplement in the country for livestock based on regional mineral mapping carried out by NDDB. Panacea Biotec launched oncology drugs Panacea launched a suite of products in the oncology sector like Paclitrust, Docetrust, Gemtrust, Zoletrust and Temotrust. It also inaugurated its Vaccine Formulation plant (VFP) in Baddi, Himachal Pradesh and entered into an agreement with Family Vaccines of the Philippines to provide access to value added combination vaccines under the umbrella of "Easy Vaccines" manufactured by Panacea Biotec, to the people in Philippines through a chain of 50 immunization clinics, run by Family Vaccines. TERI develops biopesticide against cotton bollworm Scientists at The Energy and Resources Institute (TERI) have developed a biopesticide against cotton bollworm. The product is expected to hit the market this year. Taking up the challenge for developing a biopesticide to tackle the problem of H. armigera infestation, TERI scientists began research in this area during the late 1990s with support from the DBT. The pesticide affects the growth of the bollworm larva resulting in reduction of larval weight up to 88 percent, hence restricting the larvae population, resulting in ultimate death of the larva itself, apart from its mild anti-feedancy thereby preventing the crop damage. Xcyton launches "Xcyto-Screen" diagnostic kit Xcyton Diagnostics, the Bangalore based molecular diagnostics company, announced Xcyto-Screen series of products--Xcytoscreen Keratoconjuctivitus, Uveitis, Retinitis and Endophthalmitis. This category of products detect up to 15 key microorganisms that infect both eyes and brain. Based on nucleic acid amplification technology and a macro-chip, this platform has been developed for the first time in the country and as a public-private initiative.   Government approves national biotech policy Government of India approved the much-awaited National Biotechnology Development Strategy. The strategy is an outcome of a two-year-long nationwide consultation process with multiple stakeholders including ministries concerned, universities, research institutes, private sector, civil society, consumer groups, non-government and voluntary organizations and international bodies. The strategy addresses the formation a National Biotechnology Regulatory Authority to provide a single window mechanism for biosafety clearance of genetically modified products and a high-powered Inter-ministerial Committee to effectively coordinate the development of the sector by addressing cross cutting issues. The policy also focuses on public-private partnership programs, Biotechnology Industry Partnership Programme (BIPP) for Advanced Technology. Approval has also been accorded for the expansion of SBIRI during the 11th Plan.   Nano science initiatives take off The Bangalore Nano 2007 Convention, a two-day event on nanoscience and technology and the first major event of its kind in the country was held on December 6-7, 2007, organised by the Department of Science and Technology in association with Jawaharlal Nehru Centre for Advanced Scientific Research (JNCASR). The government has made a budgetary provision of Rs 1,000 crore to promote the sector. The Nano Science and Technology Initiative (NSTI) has funded around 100 basic science projects worth Rs 60 crore.   A Nobel Prize for gene targeting Dr Mario R Capecchi, Dr Martin J Evans and Dr Oliver Smithies were honoured with this year's Nobel Prize for medicine for their discoveries of "principles for introducing specific gene modifications in mice by the use of embryonic stem cells". These Nobel Laureates have made a series of ground-breaking discoveries concerning embryonic stem cells and DNA recombination in mammals. Their discoveries led to the creation of an immensely powerful technology referred to as gene targeting in mice. It is now being applied to virtually all areas of biomedicine-from basic research to the development of new therapies. Gene targeting is often used to inactivate single genes. Such gene "knockout" experiments have elucidated the roles of numerous genes in embryonic development, adult physiology, aging and disease. To date, more than 10,000 mouse genes (approximately half of the genes in the mammalian genome) have been knocked out. Ongoing international efforts will make "knockout mice" for all genes available within the near future. With gene targeting it is now possible to produce almost any type of DNA modification in the mouse genome, allowing scientists to establish the roles of individual genes in health and disease. Gene targeting has already produced more than five hundred different mouse models of human disorders, including cardiovascular and neuro-degenerative diseases, diabetes and cancer. Dr Mario R Capecch: Born in 1937 in Italy, he didn't know how to read and write until he was 9. Later he continued to do his PhD in biophysics in 1967 from Harvard University, Cambridge, MA, USA. Currently he is Howard Hughes Medical Institute Investigator and Distinguished Professor of Human Genetics and Biology at the University of Utah, Salt Lake City, UT, USA.   Dr Oliver Smithies: Born in 1925 in Great Britain he did his PhD in Biochemistry 1951, Oxford University, UK. Currently he is Excellence Professor of Pathology and Laboratory Medicine, University of North Carolina at Chapel Hill, NC, USA.   Dr Sir Martin J Evans: Born in 1941 in Great Britain he did his PhD in Anatomy and Embryology 1969, University College, London, UK. Currently he is Director of the School of Biosciences and Professor of Mammalian Genetics, Cardiff University, UK.     Top Invention Prize for Dr Sidhu Indian-Australian stem cell scientist, Dr Kuldip Sidhu has won the 2007 Top Invention Prize for his pioneering work in stem cells. Dr Sidhu, an Associate Professor at University of New South Wales, was acknowledged for the work on the derivation of a new human embryonic stem cell line, Endeavour-1. The prize is awarded by BioMed North Limited, a not-for-profit agency for the management and commercialization of intellectual property generated within the state of New South Wales (NSW). Dr Sidhu has produced a human embryonic stem cell line without the use of any animal product. This breakthrough eliminates the risk of animal-to-human contamination in potential stem cell therapy treatments. Dr Sidhu's work could eventually lead to safer treatments for conditions such as diabetes, Parkinson's disease, spinal cord injury and even breast cancer.   Novozymes acquires Biocon's enzyme business Biocon Ltd sold its enzymes activity to Novozymes, for a total consideration of $115 million. The acquisition of Biocon's enzyme activities provides an important step for Novozymes in strengthening its position in the Indian market. RFCL acquires Wipro BioMed RFCL signed a definitive agreement to acquire Wipro BioMed, a leading provider of biomedical solutions. The acquisition of Wipro BioMed is a part of RFCL's multi-pronged inorganic growth strategy to emerge as a globally respected company in the field of life sciences solutions. The business operations of Wipro BioMed will be integrated with RFCL's diagnostics division--Diagnova. Avesthagen acquires Renaissance Herbs Avesthagen acquired Renaissance Herbs Inc., a fully-integrated supplier of proprietary nutritional products. The acquisition supports Avesthagen's bio-nutritional business strategy through vertical integration and access to key markets.   Malaysian scientists develop herbal drug for dengue A group of Malaysian scientists have discovered a breakthrough antiviral drug from an herbal extract for the treatment of dengue. This could be the world's first dengue antiviral drug based on herbal extracts. Dengue is an acute infectious, eruptive, febrile disease caused by four antigenically related but distinct serotypes of the Dengue virus. It is transmitted by the bite of infected Aedes mosquitoes, especially A. aegypti. Scientists at the Medical Department of Universiti Malaya and the Universiti Malaya Medical Centre have developed the antiviral drug, known as Dengimm2, from extracts of Artemisia and eight other local herbs. Dengimm2 was proved safe when tested on infected cells and in mice.     ]]> <![CDATA[Hyderabad varsity hosts drug discovery meet]]> https://biospectrumindia.com/news/95/7074/hyderabad-varsity-hosts-drug-discovery-meet.html https://biospectrumindia.com/news/95/7074/hyderabad-varsity-hosts-drug-discovery-meet.html Tue, 08 Jan 2008 14:57:00 +0530 New Page 1 Hyderabad varsity hosts drug discovery meet D Purandeswari, union minister of state for HRD, Government of India, inaugurating BioConvene 2007 in Hyderabad. BioConvene 2007, an instructional workshop in bioinformatics and drug discovery was inaugurated by Dr T Ramasami, secretary, DST, at the University of Hyderabad. In his inaugural speech Dr T Ramasami spoke about the importance and promotion of innovation among the students, starting from school level. He also stressed on the need for cross border interactions for the promotion of science and technology leading to drug discovery. He congratulated the center for biotechnology at the University of Hyderabad and CR Rao Institute of mathematics, statistics and computer sciences for undertaking the task of instructional workshop. Prof. K Anandkumar, organizing secretary of the workshop, explained that the objective of instructional workshop was to impart training in application of statistical methods, mathematical algorithm and biocomputing in bioinformatics. The areas of training included sequence analysis, pharmacogenomics, immunoinformatics, structure prediction, molecular modeling, docking and drug design. The participants were trained on the softwares like CLLTOX, V-life, MOE, GROMACS and Guassian with the involvement of company representatives and experts drawn from various countries. This training helped them to familiarize in analysis of genome, proteome, metabolic pathways and three dimensional structure predication and drug design. More than 80 members from universities, institutes and industries participated in the four-day workshop, which was held from December 16-19, 2007. It was organized by the Centre for Biotechnology, School of Life Sciences, University of Hyderabad under the convenership of Prof. P Reddanna, co-ordinator, Centre For Biotechnology and CR Rao Advanced Institute for Mathematics, Statistics and Computer Sciences and Penn State University, USA in collaboration with Kasyap Technologies, and Centre for DNA fingerprinting and Diagnostics. An international conference on bioinformatics and drug discovery was also conducted on December 19-22, 2007. It was inaugurated by D Purandeswari, union minister of state for HRD, Government of India, at the DST auditorium, University of Hyderabad. The inaugural session was presided by Dr Seyed E Hasnain, vice-chancellor, University of Hyderabad. Dr CR Rao, Emeritus Professor and Dr C Channa Reddy from Penn State University were the guests of honor. Speaking on the occasion, Purandeswari emphasized that in the era of globalization, the country's economy and developments are linked to the developments that are taking place in the world. She expressed the need for greater collaboration between international community and Indian scientists to promote bioinformatics as a useful tool in solving the problems in both agriculture and human health. Prof. Reddanna, co-ordinator, Centre for Biotechnology and convener of the conference explained that drug discovery is a multistage process, involving many scientific disciplines, including biology, chemistry and bioinformatics. He pointed that the conference is multidisciplinary involving fields like mathematics, statistics, computers, chemistry and biology. About 300 participants and 50 eminent speakers from India and abroad participated in this conference. As many as 100 poster presentations covering various areas of bioinformatics and drug discovery were displayed and discussed. The highlight of the conference was the talk on the use of CADD methods for discovery of clinical candidates for Type II diabetes given by Dr M Rami Reddy of Metabasis Therapeutics, USA. He explained the intelligent use of quantum mechanics, molecular mechanics and free energy perturbation methods in identifying novel lead molecules, talking Type II diabetes as a case study. A special feature of the conference was the importance of statistical methods in clinical research and clinical trials. The various methods that are required to be employed in clinical research and clinical trials were discussed. Further integration of bioinformatic tools in clinical research and design of clinical trials was emphasized. Discussions included biomarker selection using a systems biology approach, designing proof-of-concept studies, experimental design in early clinical development and bioinformatics tools studying gene-environment interaction, a sequential design for phase I trials, a statistician's perspective for planning clinical trials in India, were discussed. On the concluding day of the conference, an international symposium on forensic technology was also organized, which covered various aspects in advanced technology of human DNA forensics; microbial forensics, emerging forensic technologies and DNA profiling. Prof. K Anand Kumar announced total cash prizes worth of Rs 30,000 for six best posters, which included the CR and Bhargavi Rao prize, two Schrodinger prizes and three given by the organizers.   ]]> <![CDATA[Nanotechnology will throw open a global opportunity of $1 trillion by 2015]]> https://biospectrumindia.com/news/95/4150/nanotechnology-will-throw-open-a-global-opportunity-of-1-trillion-by-2015.html https://biospectrumindia.com/news/95/4150/nanotechnology-will-throw-open-a-global-opportunity-of-1-trillion-by-2015.html Tue, 08 Jan 2008 14:49:00 +0530 New Page 1 Indian Institute of Nanoscience and Technology to come up in Bangalore Nanotechnology will throw open a global opportunity of $1 trillion by 2015 Rameshwar Thakur, governor of Karnataka, inaugurating Bangalore Nano 2007. MN Vidyashankar, secretary, Department of IT, BT & Science & Technology, Government of Karnataka, (second from right) Prof. CNR Rao, chairman, science advisory council to the prime minister and president, JNCASR, and (extreme right) Jagdish Patankar of MM Activ, look on. The first edition of Bangalore Nano organized by the Department of IT, BT and Science & Technology, Government of Karnataka, Jawaharlal Nehru Centre for Advanced Scientific Research (JNCASR) and MM Activ, provided a platform for all stakeholders in the field of nanotechnology to congregate and discuss and share their ideas and to envision a roadmap for India in nanotechnology. Experts equivocally said that nanotechnology cuts across all industries like automotive, IT, food, health, steel, textiles, energy, paints, cosmetics and defense and it would provide a global opportunity of $1 trillion by the year 2015. Prof. CNR Rao, chairman, Science Advisory Council to the Prime Minister and president, JNCASR, said, "India has made a beginning in nanotechnology and Bangalore Nano is the first large scale nanotechnology event in India. The applications of nanotechnology extends from sensors, displays, transistors, data storage, storage of hydrogen for fuel cells, photovoltaic cells for harnessing solar energy, water purification to steel and rocket propellants. Ideally, India should get into the manufacturing of sensors in a big way as it is a knowledge based industry." Prof. Rao added, "Indian researchers can make any nanomaterials at any form required but the biggest challenge lies in assembling of these nanomaterials. We are still looking at technologies to assemble these nanomaterials to make final commercial products. There is a huge demand for nanomaterials globally. India should be ideally catering to this global demand in the years to come." MN Vidyashankar, secretary, Department of IT, BT & Science & Technology, Government of Karnataka, informed, "The Karnataka government has identified a 14-acre plot to set up Indian Institute of Nanoscience and Technology in Bangalore. The institute has already received a funding of Rs 100 crore from the Central government." Dr Patrice Millet, program officer, European Commission, which participated in the event as a country partner, said, "Public funding in Europe has become the largest investor in the world into nanoscience and nanotechnology. International co-operation is increasing in this field for the development of nanotechnology worldwide. The funding from the European Commission is also going to increase for the research and development in the field of nanosciences and nanotechnology." Dr Faruq Marikar, MD, Nanobiz, USA said, "As India is gaining entry into the global top tier in numerous industry sectors, Innovation should come in naturally. Indians have proven that they can innovate in disciplined ways, here, there and everywhere. The necessary and sufficient conditions for innovation are trained scientists and engineers, tools and equipment and creative talent. A lot of learning is necessary to get there; and help is available if you ask for it, and pay for it." Dr Pradip, Tata R&D Design Centre, Pune, felt, "Process engineering and scale up issues are critical in nanotechnology. To meet application needs of the common man, an innovative use of existing technology and new business models are needed." Speaking on venture capital in materials science and nanotechnology, Prof. Anthony K Cheetham, Department of Materials Science and Metallurgy, University of Cambridge, said, "It is easy to spot the commercial potential of a research finding in nanotechnology, but the time to market is very long. It is illustrated by lack of commercial success of many start-ups in the nanotechnology area." Illustrating on various applications of nanotechnology, Prof. Cheetham said, "Nanomaterials can be made into nanoparticles, nanotubes, nanowires, nanorods and nanosheets. Nanotubes can substitute steel as they are 10 times stronger than steel and six times lighter. Nanocrystals of aluminum could be used for rocket propellants." He added, "Earlier emphasis of venture capitals was on investments in the nanomaterials and nanotechnology area. In last 2-3 years, emphasis shifted towards cleantech area, with applications in solar energy, water treatment, energy storage, fuel cells and emission controls. There are also some unanswered questions concerning toxicology issues as well as societal concerns." Bhuvaneashwar Subramanian, senior research analyst-technical insights (healthcare), Frost and Sullivan, opined, "It would take a fair while before nanobiotechnology gets widely accepted amongst the masses and probably a bit longer before nanobiotechnology based products flood the market. With increasing research across several labs in the world, the future of nanobiotechnology lies across the areas of diagnostics, prosthetics and therapeutics. One can expect to see a buzz of activity in these areas owing to the increasing need in society for alternative solutions that would enable people live comfortable. The future thus for nanobiotechnology is to spearhead the concept of convenience healthcare through increased applications in non invasive healing and thereby augment the existing methodologies of treatment and offering patients the freedom to choose the most convenient option." The challenges for commercialization of nanobiotechnology in India do not belong to India alone but are commonly faced global challenges and they include: competition from developed technologies, lack of adequate infrastructure, toxicity issues of nanomaterials and lack of process standardization, he pointed out. Dr G Sundararajan, director, ARCI, Hyderabad, noted, "The three challenges we face in commercialization of Nanomaterial technologies are bridging research and industry gap, skilled human resource and health, safety and regulation issues." Funding A consensus evolved that the economic results of nanotechnology look more certain compared to Information Technology and thus there is no dearth of funding by private and government. The US federal funding for nanotechnology is $800 million per annum. The Japanese government also funds the same amount. Europe has a funding of $1.2 billion per annum. In China funds of $150 million are available from both private and government per annum while India has an outlay of $100 million per annum. The funding toward nanotechnology applications is largely from DST, DSIR and DBT. The total funding by these funding agencies amounted to $20 million until 2003-04 out of an annual R&D expenditure of $3.03 billion. The government has allocated Rs 1,000 crore ($250 million) through the NSTI for nanotechnology research from 2007. During the last five years the total investment in nanotechnology has been $50 million While the funding for nanobiotechnology in India is not very high compared to funding in countries such as the US, the funding efforts need to be appreciated. The proposed increase in funding is a good start and is bound to increase over a period with more innovations being developed with the course of time in the Indian terra firma. Namratha Jagtap   ]]> <![CDATA[APAC Biotech Policy Highlights]]> https://biospectrumindia.com/news/95/6848/apac-biotech-policy-highlights.html https://biospectrumindia.com/news/95/6848/apac-biotech-policy-highlights.html Tue, 08 Jan 2008 12:22:00 +0530 New Page 1 APAC Biotech Policy Highlights Japan   The Japanese government issued a strategic plan in 2002 to focus research and commercial efforts based on emerging bio-based technologies. The goal was to stimulate the economy while addressing two pressing concerns: an aging population and a depletion of natural resources. The plan concentrates on four areas of research capitalizing on Japan's strengths in genomics research and technological proficiencies: â€¢ Pharmaceuticals â€¢ Medical supplies & equipment â€¢ Microbial and Bioprocess Engineering â€¢ Functional foods New Zealand   Released in May 2003, the New Zealand Biotech Strategy is based on three key objectives â€“ promoting community understanding & connection, growth and effective regulation. As far as implementation goes, the Bioethics Council provides independent advice to the Government on biotechnological issues that have significant cultural, ethical and spiritual dimensions. Amendments to the Hazardous Substances and New Organisms Act (HSNO) strengthened the provisions for consideration of cultural, ethical and spiritual matters. The ministerial call-in powers have been extended to include these matters. Also, amendments to reflect better the Treaty of Waitangi include adding knowledge and experience of the Treaty and tikanga Maori to the knowledge and experience that the Minister for the Environment considers when appointing members of the Environmental Risk Management Authority (ERMA) Board. China   In early 2006, China adopted a 15-year "Medium-to Long-Term Plan for the Development of Science and Technology" (MLP) with an aim to become an "innovation-oriented society" by the year 2020, and a world leader in science and technology (S&T) by 2050. The MLP is built around developing indigenous innovation capabilities in the new science-intensive industries. According to the plan, China will invest 2.5 percent of its increasing gross domestic product in R&D by 2020, up from 1.34 percent in 2005; raise the contributions to economic growth from technological advance to more than 60 percent; and limit its dependence on i mported technology to no more than 30 percent. Korea   "In 1999 the ""Long-range Science and Technology Development Vision Toward 2025"" was established, with a goal of promoting science and technology competitiveness to the G7 level by 2025. In 2001 the Science and Technology Basic Law was enacted. The Science and Technology Principle Plan (2002 - 2006) was enacted in conjunction with a five-year plan on science and technology reform that was already underway. In 2004, the headquarters of Science and Technology Innovation was established under the Ministry of Science and Technology. In 2006, Korea outlined its Bio-Vision 2016 Plan. In this plan the Ministry of Science and Technology of Korea proposed to invest $14.3 billion in biotechnology research and industrialization over the next 10 years to create a $60 billion market by 2016. This investment will drive Korean biotechnology industry to capture the seventh position in the world from its current position 14." Australia   In 1999 the Government established Biotechnology Australia and the Commonwealth Biotechnology Ministerial Council to coordinate government biotechnology activity and to develop a national biotechnology strategy. The Government also established the Biotechnology Consultative Group (BIOCOG), a panel of experts from industry and the industry and the scientific research community, to provide independent advice to government. The National Biotechnology Strategy addresses the six key themes: Biotechnology in the community; Ensuring effective regulation; biotechnology in the economy; Australian biotechnology in the global market; resources for biotechnology; and maintaining momentum and coordination. Australia has put in place excellent regulatory infrastructure including the Office of the Gene Control Regulator (OGTR) to smoothen GMO approvals. Singapore   The Singapore Biomedical Sciences (BMS) initiative was launched in June 2000 to develop the Biomedical Sciences cluster as one of the key pillars of Singapore's economy, alongside Electronics, Engineering and Chemicals. To achieve its aim, the BMS initiative is led and coordinated both by a Steering Committee on Life Sciences, comprising the Ministers for Trade & Industry, Health and Education, and the BMS Executive Committee. The first phase of development (2000-2005) of the Biomedical Sciences (BMS) initiative was focused on establishing a firm foundation of basic biomedical research in Singapore. In the second phase (2006-2010), the focus is on deepening our basic research capabilities and strengthening translational and clinical research (TCR) to help realize the full potential of our investments in the BMS initiative with the translation of laboratory discoveries to clinically useful and commercially viable applications. The country's biomedical policy came under heavy criticism by World Bank in early 2007 for resources being spread too thinly. However, the Government's Agency for Science, Technology and Research (A*STAR) stated that there is no rethink or a change at the broad policy level while the debate still continues on what is the most gainful deployment of resources. Thailand   Thailand finalized the National Biotechnology Policy framework in 2005. The key strategies include: 1) To construct/develop infrastructure such as a biotechnology park to attract both domestic and overseas investment, as well as using services in research and development. 2) To set forth clear policy or management to settle some highly controversial issues, such as issuance of law on protection of bioresources and policy on the development of safe GMOs products. 3) To create an environment and incentives for venture capital to be invested in biotechnology, which needs a longer period than other industrial technologies for the return of the investment. These include taxation privileges, in particular import duties, corporate tax and co-ownership of the rights to utilize bioresources where Thailand has a particular advantage. 4) To promote investment in research, development and innovation, as well as cultivate capability for biotechnology research following the concept of cluster research, skill-based technology and innovation approaches 5) To support the listing of biotechnology companies on the Stock Exchange of Thailand. Malaysia   "Malaysia's National Biotechnology Policy unveiled in 2005 encompasses nine thrusts that underline its commitment to the sector: · To transform and enhance value creation of the agricultural sector through biotechnology. · To capitalize on the strengths of biodiversity to commercialize discoveries in health-related natural products and bio-generic drugs. · To leverage our strong manufacturing sector by increasing opportunities in bio-processing and biomanufacturing. · To establish biotechnology centres of excellence in the country, where we bring together multi-disciplinary research teams in coordinated initiatives. · To build the nation's human capital in biotechnology via education and training. · To develop financial infrastructure to support biotechnology. · To improve the country's innovation system by reviewing the country's legal and regulatory framework. · To build international recognition for Malaysian biotechnology. · To establish a dedicated and professional agency to spearhead the development of Malaysia's biotechnology sector." Taiwan   The Promotion Plan for the Biotechnology Industry, a road map defining national industry goals and clearly detailing the corresponding action steps required to get there, was first written and released by the Executive Yuan branch of the government in 1995, and has been revised biannually ever since. A major aspect of the Promotion Plan is that it has identified specific areas in need of attention to upgrade not only the local biotech industry but also to enhance the investment attraction of Taiwan to the overseas life science community. These five areas of attention are: â€¢ Related laws and regulations â€¢ R&D and application â€¢ Technology transfer and commercialization â€¢ Investment promotion and cooperation â€¢ Marketing information and services. ]]> <![CDATA[Innovative regulator]]> https://biospectrumindia.com/news/95/2421/innovative-regulator.html https://biospectrumindia.com/news/95/2421/innovative-regulator.html Tue, 08 Jan 2008 12:12:00 +0530 New Page 1 Innovative regulator The mission of the Health Sciences Authority of Singapore is to wisely regulate health products, serve the administration of justice and secure the nation's blood supply Talking about government regulatory agencies is as interesting as watching grass grow. On face value, the topic is considered by most rational human beings as bland. So, when I say that one of the most important institutions in Singapore's advance in biomedicine is in the organization that regulates its blood supply and the availability and safety of drugs here, I expect eyes to roll with the exhaled sighs of disbelief. But indeed, this is true. Dr Edison T Liu Executive director of the Genome Institute of Singapore, Dr Edison T Liu, is a physician-scientist who trained with Nobel Laureate, J Michael Bishop. He is also the executive director for the Singapore Cancer Syndicate - a funding agency, the Singapore Tissue Network - the national tissue repository, and is chairman of the Health Sciences Authority of Singapore, the country's FDA equivalent. The institute I will be discussing, and for which I am the Chairman of Board, is the Health Sciences Authority (HSA)-the statutory board of Singapore's Ministry of Health formed in April 2001 that manages a collection of important health regulatory roles (http://www.hsa.gov.sg/publish/hsaportal/en/home.html). The HSA is charged with regulating which drugs and devices are allowed to be sold in Singapore (health product regulation), it runs the national blood bank and transfusion medicine services for the country, and it is the expert center for analyzing biological samples at crime scenes (forensic or national crime laboratory). So, HSA houses under one roof the equivalents of what are normally several agencies in other countries. In the US, the HSA would be equivalent to the Food & Drug Administration agency (FDA), the Red Cross (blood banking), and the Crime Scene Investigations (CSI) or the FBI crime laboratories. The mission of the HSA is to wisely regulate health products, serve the administration of justice and secure the nation's blood supply, all towards the fundamental aim of safeguarding public health. So why is this agency such a lynchpin for good public health and of biomedical innovation? A related question is why are quality regulatory agencies essential for the public good and national wealth? The answer is easily found in the economic sector where the regulation of the monetary and financial system is essential for advanced and competitive economies. The critical role of the Monetary Authority of Singapore, the Bank of China, the Federal Bank and the Securities Exchange Commission of the US to national prosperity and economic growth is uncontested. A more dire example is the recently reported disasters involving the Chinese drug regulatory agency the SFDA whose corrupt practices jeopardized the health of Chinese citizens and caused global product recalls costing billions of dollars. Some would say, equally problematic is over-regulation as has been seen in the Japanese Ministry of Health's ban on birth control pills until 1999. Over-regulation blocks access to key drugs, sometimes life saving medicines. Any process involving human transactions needs a fair set of rules and good referees. The alternative is distrust and chaos: progress stops. Challenges of regulation To be a government regulator is one of the most difficult jobs because there is no clear metric to determine success. Unlike business where positive cash flow is a simple single measure of success, or academia where the publication record is paramount, no one can specify simple performance targets for a regulator. How many products approved or rejected, or measuring the number of recalls are clearly inappropriate measures of goodness. Instead, a good regulator should be judged by three characteristics: efficiency, transparency or clarity, and righteousness. The first characteristic can easily be measured: what is the turn-around time for products to receive a decision (not time to be approved). Transparency can be measured by: how clear a regulator's guidances are and the brevity of the rules book (the shorter the better). Righteousness is the hardest to measure, but is found in the respect of one's own governmental peers in the regulatory institution. For example, the US Supreme Court receives very high ratings from other governmental agencies. In this fast moving environment spurred by heightened expectations by Singapore's citizens and government, the HSA has recognized that it cannot function in a business-as-usual or traditional mode. The challenge for the HSA is how to regulate the same number of products that another sovereign nation like the US regulates but with 1/100th the human resources of the US FDA. So, what are some of the solutions? First, one must regulate with intelligence. This means that whenever possible, for drugs already examined carefully in key index regulatory agencies (like the US FDA, the Australian TGA, and the European Union's EMEA) HSA will expedite its review and not reinvent the wheel. The HSA concentrates on those drugs that have no regulatory history, and those with unique properties such as medicines with significantly different effects across ethnic groups. Though these may be difficult aims to achieve given that HSA is and will always be a small agency when compared to large agencies like the US FDA. But these can be achieved if there is (a) clarity about HSA's regulatory philosophy and operations, (b) international networking and benchmarking to add value in fundamental regulatory activities, (c) organizational innovation with a focus on efficiency, and (d) intelligent and appropriate resourcing in manpower and financing. Regulatory innovation While HSA must adhere to international regulatory standards, it cannot simply follow the operational and organizational plans used in larger countries. Instead, HSA seeks to take advantage of the compactness of Singapore and the presence of mature networking systems to enhance its surveillance and enforcement capabilities. The Singapore government has given the HSA a major legislative tool recently in the new Health Products Act (http://statutes.agc.gov.sg/non_version/cgi-bin/cgi_legdisp.pl?actno=2007-ACT-15-N&doctitle=HEALTH%20PRODUCTS%20ACT%202007%0A&date=latest&method=part&sl=1). The Act's modular approach and mechanism to activate relevant clauses means that instead of a one-size-fits-all approach, the regulatory requirements can be tailored according to the degree of risk. At the same time, the Act provides the necessary flexibility making it simpler to fine-tune the regulatory regime for different products over time. This is important in order to accommodate new discoveries that will come into the market in future. In another on-going example, the National Healthcare Group (NHG) which covers almost one-half of the country's public health care delivery has a system that automatically prompts physicians to input information on unusual side effects of drugs (or commonly called adverse drug effects), but then passes this information to HSA's Pharmacovigilance Unit. This effectively means that HSA is able to receive 100 percent of adverse event records from NHG institutions in a secure manner. In this manner, HSA can pick up key adverse events more efficiently and effectively than its developed country counterparts. At the end of the day, there is no perfect model for a health regulator to adopt. But the HSA aims to be innovative and flexible, always acting with integrity and continually seeking efficiency. In so doing, it has a high likelihood of making a positive impact not only on the health and safety of Singaporeans but also, as a model of an effective regulator, on world public health.   ]]> <![CDATA["The objective is to identify and manage the risk"]]> https://biospectrumindia.com/news/95/1752/the-objective-is-to-identify-and-manage-the-risk.html https://biospectrumindia.com/news/95/1752/the-objective-is-to-identify-and-manage-the-risk.html Tue, 08 Jan 2008 12:05:00 +0530 New Page 1 "The objective is to identify and manage the risk" -Dr Sue Meek, gene technology regulator, Australia Australia is a trendsetter in setting up the unified regulatory structure for GMOs with its Gene Technology Act 2000, which is in force since June 2001. Managing the complexity of enforcing the regulation is the Office of Gene Technology Regulator (OGTR) headed by Dr Sue Meek, who is an independent statutory office holder responsible for administering and enforcing the national regulatory system for the development and use of gene technology. With 25 years of experience behind her, Australia's scientist-turned gene technology regulator is in charge since December 2001. Holding the office of the country's first gene regulator is a complex, tough task. Dr Meek shares with BioSpectrum how OGTR handles the complexity of the task. Can you give a brief outline of the background of the Gene Technology Act 2000? What factors let to the formation of this Act and how has this helped the industry and public health initiative in Australia? The use of gene technology in Australia was previously governed by a voluntary system overseen by the Genetic Manipulation Advisory Committee. It was decided that a national scheme for regulating gene technology was necessary as the range of applications for gene technology was changing very rapidly and legally enforceable ways to audit or monitor the use of gene technology and penalise breaches were needed. The development of the Gene Technology Bill 2000 (the Bill) involved extensive consultation with all Australian jurisdictions and was conducted in four stages: In 1998, a paper entitled "Regulation of Gene Technology" was circulated for limited public consultation, after which, a set of policy principles was agreed by the Commonwealth State Consultative Group on Gene Technology. In 1999, the discussion paper "Proposed national regulatory scheme for genetically modified organisms â€“ How should it work?" was released for public consultation and invitations to attend targeted consultations were sent to approximately 1,000 individuals and organizations across Australia. A consultation draft of the Bill was prepared by the Commonwealth Office of Parliamentary Counsel. The draft Bill was released for public comment. Calls for submissions and invitations to public forums were published in newspapers in all jurisdictions and mailed directly to over 2,500 interested stakeholders. In 2000, the Bill was referred to a Senate Committee Inquiry and subjected to extensive debate in the Australian Parliament. It was passed into law in December 2000 and commenced operation on June 21, 2001. The Gene Technology Act 2000 (the Act) is the Australian Government's component of the nationally consistent regulatory scheme for gene technology. Under the Gene Technology Agreement 2001, all States and Territories have committed to maintaining corresponding legislation. The object of the Act is to protect the health and safety of people, and to protect the environment, by identifying risks posed by or as a result of gene technology, and by managing those risks through regulating certain dealings with genetically modified organisms (GMOs). The Act regulates both intentional release of GMOs into the environment and research in contained laboratory facilities. In drafting the gene technology legislation, Australian governments decided to confine the Regulator's powers to the consideration of risks to human health, safety and the environment. This was due in part to feedback received during the consultation process which identified strong community concerns that a requirement to consider economic issues, such as the marketability of GM crops, could compromise the regulatory system's focus upon the protection of people and the environment. How often do the various committees meet? And what is the coordination process you follow while liaising with other agencies such as TGA? The Act established three advisory Committees: the Gene Technology Technical Advisory Committee (GTTAC), the Gene Technology Ethics Committee (GTEC) and the Gene Technology Community Consultative Committee (GTCCC). From January 1, 2008, GTEC and GTCCC will be replaced by the Gene Technology Ethics and Community Consultative Committee (GTECCC). The establishment of GTECCC was among a number of changes to the Act made by the Gene Technology Amendment Act 2007 that was passed in June 2007. GTTAC meets three-to-four times a year on average, and is also consulted out-of-session. It is anticipated that GTECCC will meet two-to-three times per year. The Act requires extensive consultation with key stakeholders and the public on applications to release GMOs into the Australian environment. The methods of communication used by the Regulator include sending letters or emails directly to relevant stakeholders and posting advertisements on the OGTR website and in national, state and regional newspapers. The Regulator is required to seek advice and comment on the Risk Assessment and Risk Management Plans (RARMPs) prepared for each of these applications from a wide range of experts, agencies and authorities. Those consulted include the State and Territory Governments, the Australian Government Environment Minister, other Australian Government regulators prescribed in the legislation (Food Standards Australia New Zealand (FSANZ), the Australian Pesticides and Veterinary Medicines Authority (APVMA), the Therapeutic Goods Administration, the National Industrial Chemical Notification and Assessment Scheme and the Australian Quarantine and Inspection Service), GTTAC, and relevant local councils. The Act also requires the Regulator to invite submissions on the RARMP from members of the public. The Act forms part of the integrated regulatory framework for the development and use of GMOs in Australia. All Australian Government regulators, mentioned above are also required to consult the Gene Technology Regulator when considering GM products (i.e., not live and viable). The regulation of GM (and non-GM) food is the responsibility of FSANZ. The regulation of agricultural chemicals, including the use of herbicides on herbicide tolerant (GM or non-GM) crops, is principally the responsibility of the APVMA. How many applications come to your office every year and how many get cleared? What is the time frame that an application takes from filing to clearing? In 2006â€“07 the OGTR received 1474 applications and notifications as defined under the Act. Fluctuations in the timing and volume of application lodgement can be influenced by factors such as research grant funding cycles and seasonal agricultural factors. Licences for DIRs issued in 2006â€“07 ranged from limited and controlled releases (field trials) to Australia-wide commercial releases of GMOs. Ten decisions on applications for DIR licences were made during the reporting period. All were made within the statutory 170 working day timeframe. Approvals do not necessarily occur in the same year as applications are received. India is planning to emulate Australia's unified regulatory structure. What would be your advice to India and other Asian countries that are looking at outlining a similar regulatory structure and implementing it? The object of the Act, which underpins the regulatory system, is to protect the health and safety of people and the environment. This is achieved by focusing on risk and ensuring that any risks to the health and safety of people and the environment posed by, or as a result of, gene technology are identified and managed. The recent Review of the Act found that this object is being achieved and that Australia's regulatory framework is appropriate and being applied effectively. Learning from the Australian experience, what are the implementation bottlenecks of putting in place such as structure that other countries can be forewarned about and thus be better prepared to handle it? The most time consuming aspect of developing the national regulatory framework for GMOs was the extensive public consultation conducted. However, this process was necessary to ensure a clear understanding of the differing positions of all interested parties, and to provide information to interested parties to improve understanding of the issues involved. The development and implementation of the Act included transitional arrangements for approvals made under the former voluntary system. Nandita Singh   ]]> <![CDATA[State Biotech Policies]]> https://biospectrumindia.com/news/95/2601/state-biotech-policies.html https://biospectrumindia.com/news/95/2601/state-biotech-policies.html Tue, 08 Jan 2008 11:34:00 +0530 New Page 1 State Biotech Policies Many of the state governments have been very proactive in formulating specific policies to promote biotech in their states. Here is a snapshot of some of the prominent states.   ]]> <![CDATA[Biotech for a billion people ...]]> https://biospectrumindia.com/news/95/5118/biotech-for-a-billion-people-.html https://biospectrumindia.com/news/95/5118/biotech-for-a-billion-people-.html Tue, 08 Jan 2008 11:29:00 +0530 New Page 1 Biotech for a billion people ... The biotechnology industry is slowly but surely coming into its own. Biotechnology is no longer just a "buzz-word"; its impact has started touching the lives of ordinary people of our country. Medicines and vaccines for human and animal health, produced through recombinant DNA technology, are now increasingly available here. Almost two-thirds of all the cotton grown here is Bt-cotton, the transgenic variety that has the ability to resist damage from the most serious group of cotton-pests, the boll worms. There are a large number of institutions, both in the public and the private sector, involved in research and development in this sunrise sector. The nascent biotechnology industry is slowly but surely coming into its own; the annual turnover from this sector in 2006-07 touched over Rs 8,300 crore, clocking an annual growth rate of close to 32 percent. As our nation comes out of its throes of poverty and underdevelopment, fuelled by a double digit growth of its economy, affordability, equity or inclusiveness, and sustainability have to be the watch words. A biotechnology-led growth (which I must emphasize is not to undermine the importance of any of the other sectors) easily satisfies these conditions. The developments in the area of vaccine production in this country in the last decade have made recombinant vaccines within easy reach of the common man. The prices of say, the Hepatitis B vaccine, have fallen by over 10 times with the emergence of local competition in its manufacture. Biotechnology now offers options to develop vaccines for diseases that are scourges, particularly for the tropical and developing countries. This would be an important approach for countries like ours, seeking cost-effective solutions in health care through prevention rather than cure. The major complaint we hear today is about the present economic boom bypassing the rural hinterlands of the country. Obviously, a service-sector led growth has to be focused around urban infrastructure. This is true to some extend for the manufacturing sector as well. However, biotechnology, through its impact on crop productivity and quality can directly improve farm incomes thus bettering the lives of over two-thirds of our population, who happen to be in rural areas. The last five years have seen a remarkable success story in Bt-cotton. From nothing in 2001, today, the Bt-cotton is grown in over 5.5 million ha, the largest in the world! The total cotton production in the country has grown from a little over 14 million bales (of 170 kg) in 2002 to almost 30 million bales, while the area has remained almost constant. We have overtaken the US in total production and in the last two years, India has become a net exporter of cotton--we even export to China, which is the only country that produces more cotton than us! The country will export 7-8 million bales of cotton in 2007-08. The bottomline in all this is the tangible monetary benefits accruing to the cotton farmers who have adopted this technology at an unprecedented rate. Biotechnology based solutions are environment friendly and often, resource and scale neutral. The transgenic crops that ward off the insect pests have resulted in a significant reduction in the consumption of environmentally harmful agricultural chemicals. The resource inputs needed in this sector are usually renewable and the end products environmentally degradable. Take bio-energy for instance. With the depleting scenario of petroleum resources, large, growing economy like ours, which are energy deficient but are blessed with large tracts of land and year-round crop growing seasons, have much to gain by investing in this area. In short, biotechnology offers potent solutions to the many problems that we face in the areas of health, food and nutritional security and environmental protection; all extremely important for the sustainable development of our country. Though we have made some significant, first steps in this direction, there is still a long way to go. Uninformed opposition and needless controversies only result in unnecessary delays in utilizing this technology for the welfare of citizens and growth of India, which we can ill afford at this moment. In fact, given our natural resources and the latent talent pool, we could be significant global players in this sector, serving humanity much beyond our borders. The National Biotechnology Policy was announced a few weeks ago, after a rather long gestation period of wide-ranging consultations and some avoidable dithering. In the end, it makes all the right statements and lays out an unambiguous action plan considering the priorities for India. The success of this policy, however, would depend on its diligent implementation. It's time therefore to "walk the talk". Note: Starting this issue, Dr Narayanan will write a regular column on biotech policy, industry and other related areas and respond to issues raised by the readers of BioSpectrum.   ]]> <![CDATA[The Pharma story]]> https://biospectrumindia.com/news/95/5863/the-pharma-story.html https://biospectrumindia.com/news/95/5863/the-pharma-story.html Tue, 08 Jan 2008 11:18:00 +0530 New Page 1 The Pharma story India's first pharmaceutical company, Bengal Chemicals and Pharmaceutical Works, came up in Kolkata in 1930. But bulk of the drugs were imported. The pharma industry came into existence in the 1970s, thanks to a government policy initiative. A decision to amend the Indian Patents Act, 1970 in 1971, which disallowed product patents in pharma and agrochemicals and instead grant five-year patents to processes spurred Indian entrepreneurship in the pharma sector. The rest is history. In 35 years, India's pharma industry has scaled several heights. India is today the fourth largest in the world in pharma product volumes. And is ranked thirteenth globally in terms of sales revenues. This ranking is low mainly because the generics-based industry earns roughly one-fortieth of the price of a similar product in the developed market. A series of government policy interventions spurred entrepreneurship in the pharma sector. The National Drug Policy of 1986 provided a coherent policy framework to encourage the evolution of a domestic pharma industry to make available affordable medicines the citizens. Subsequently, the policy was revised in 1994, after the economic liberalization started in 1991. This followed the recommendations of the Prime Minister's Advisory Council on Trade and Industry to treat pharma as a knowledge-based industry in which India has a comparative advantage. The economic liberalization process also initiated some major changes that helped the industry. These were: Abolition of industrial licensing to manufacture all drugs and pharmaceuticals except for bulk drugs produced using the recombinant DNA technology, bulk drugs requiring in-vivo use of nucleic acids and specific cell/tissue targeted formulations. Private sector allowed to manufacture five bulk drugs from 1999 which were earlier reserved only for the public sector pharma units Automatic approval for foreign direct investment (FDI) increased to 100 percent Automatic approval for technology imports for all bulk drugs, intermediaries and formulations, except biotech drugs Promotion of R&D by increasing weighted deduction of 150 percent in income tax for R&D investments by companies. As Indian pharma companies began to establish their presence in the global markets to emerge as key generics manufacturers, policy makers stepped in once again to tweak the policy regime to further boost the industry. In 1965-66 India exported pharma products worth Rs 3.05 crore. India's pharma exports in 2005-06 was a whopping Rs 21,000 crore Number of companies in 1970: 200; Number of companies in 2007: 10,000 with nearly 700 medium-size companies and 200 of them focusing on high quality research. The others are formulators. Market share of MNCs in 1970: 70 percent: Market share of MNCs in 2007: 30 percent Investments in pharma in 2970: Rs 250 crore; Investments in 2007: Rs 8,000 crore Annual industry growth rate in 1970s: 3 percent; Growth rate in 2007: 9 percent Today India has the second largest USFDA-approved pharma manufacturing plants outside the US. The last count: 84 in November 2007 India drug prices are among the lowest in the world Indian companies like Serum supply more that half the annual global requirements of pediatric vaccines India was expected to switch to the product patent regime when the World Trade Organization (WTO) was set up in 1995. Indian government fought hard to get a 10-year 'grace period' to introduce the product patent regime under the TRIPS (Trade Related Intellectual Property Services) guidelines, mainly to prepare the Indian pharma industry for this. The product patent regime came into force in January 2005 after suitable amendments to the Indian Patent Act, 1970. Here too, the incremental innovation definitions adopted by India favors domestic pharma industry. National Pharma Policy 2002 In 2002, the pharma policy was further revised to make it more industry-friendly. One of the key initiative was to set up a Pharmaceutical Research and Development Committee, chaired by the Director-General of CSIR. Subsequently, a Drug Development Promotion Fund (DDPF) and a Pharmaceutical Research & Development Support Fund (PRDSF) were set up. These funds get over Rs 200 crore every year from the R&D cess levied on technology imports which are now used to promote drug research and development by companies. A revised National Pharma Policy which will aim to make available life saving drugs at affordable rates is also in the works now.   ]]> <![CDATA[India advantage]]> https://biospectrumindia.com/news/95/2141/india-advantage.html https://biospectrumindia.com/news/95/2141/india-advantage.html Tue, 08 Jan 2008 11:04:00 +0530 New Page 1 India advantage Kapil Sibal, Science & Technology Minister, India If global companies have to move forward, they must have an India strategy A few days after announcing the new biotechnology policy, India's Science & Technology Minister, Kapil Sibal, dwelt at length on India's advantages in R&D and innovation, at an event organized by the Federation of Indian Chamber of Commerce and Industry (FICCI) in New Delhi. Excerpts from interventions during the event: What are India's advantages in the global economic landscape? One of India's advantages is that it is a living and working democracy. It is perhaps because of this foundation that India's economy is growing at eight-nine percent in recent years that has given the opportunities for entrepreneurs and ordinary people to move ahead. How is it translating into promoting innovation? When I think of innovation and India advantage, there are two factors that come to my mind. The first advantage is that India today has a middle class population that is 300-million strong and the economic opportunities created by this segment are huge. The middle class lives in a relatively highly networked space and interconnects with the rest of the world very easily. So what you see in India now is the connectivity that is happening on the ground with companies, multinationals coming to India and connecting with the 300 million people and become the driver of products and process in India. That's advantage India. That explains why 200 of the Fortune 500 companies are in India. These companies have some of their largest R&D bases in India. If global companies have to move forward, they must have an India strategy. That India strategy involves sourcing not just talent from India but sourcing the market in India to exploit the world market. What are India's advantages in the life sciences sector? If we look at the pharma sector, most of the big pharma MNCs have come to India. They have made investments and this is not only for doing contract research but some of them are involved in innovation with Indian companies. Indian pharma companies are now sharing the intellectual property rights with big multinationals. It's no longer feasible for MNCs to invest $3-4 billion to develop a new drug outside of India when the cost of manufacturing the drug is much lower in India. The innovation costs, HR costs and economic costs are much lower than elsewhere. Our pharma companies are now acquiring companies in Europe and the US. It's very difficult for a mid-sized pharma company to survive in the US because the costs are high and there is stiff competition. Indian companies are buying these companies along with their IP rights and then manufacturing the same drug in India at much lower cost making them competitive in the world market. Shalini Gupta   ]]> <![CDATA[Walk the Talk on Policy]]> https://biospectrumindia.com/news/95/2167/walk-the-talk-on-policy.html https://biospectrumindia.com/news/95/2167/walk-the-talk-on-policy.html Tue, 08 Jan 2008 11:03:00 +0530 New Page 1 Walk the Talk on Policy On the occasion of BioSpectrum Awards Nite on December 21, 2007, BioSpectrum organized a panel discussion to gauge the mood of the industry and understand the implications of the National Biotechnology Development Strategy. Prof. Samir K Brahmachari, the new chief of Council of Scientific and Industrial Research (CSIR); Dr Cyrus Poonawalla, chairman, Serum Institute, Pune; Dr Kiran Mazumdar-Shaw, CMD, Biocon; Dr KK Narayanan, managing director, Metahelix Life Sciences Private Ltd and president, Association of Biotech-Led Enterprises (ABLE); and Dr S Natesh, senior advisor, Department of Biotechnology, Government of India participated in the discussion moderated by N Suresh, Group Editor of BioSpectrum (India and Asia). Biotechnology has been seen as an extension of the knowledge sector after the success of IT and telecom. "That's how biotech came into prominence as an emerging industry. The government opened the IT sector with a policy in 1986, which actually led to the emergence of the software services industry. Further the National IT Task Force recommendations in 1999 paved the way for the opening up of the telecom sector and the creation of the BPO industry. Similarly, the National Telecom Policy 1994 has created the booking mobile telephone industry, which has become the world's second largest in size in just a decade. The biotech sector today is at a similar juncture. So we would like to know what are the similar things that can happen to the biotech industry with the new policy?" said N Suresh, inviting the panelists to share their observations, concerns, and key challenges. Suresh also asked the panelists whether they foresee the emergence of a totally new industry segment within biotech, which is not there now but in 5-10 years due to the impact of the Biotech Policy. Excerpts from the panel discussion on the Biotech Policy. Dr Kiran Mazumdar-Shaw: I was very much involved in the process of developing this strategy documentation. One of the very important aspects of this policy framework is the participation of the all the key stakeholders in creation of this document. Because of this, several features concerning the development of India's biotech industry have been very effectively portrayed in this document. The focus has been on addressing the regulatory issues. The goal was how to create a national biotech regulatory authority that will actually help regulate the sector and evolve a regulatory framework that would be very conducive for developing biotech products and bringing them into the market place, complying with the safety, efficacy and other norms of the regulators and with a strong focus on timelines. The aim is to see quick introduction of biotech products and at affordable prices. The second aspect was about giving fillip to innovation and nurturing innovation across the board. The third aspect was related to encouraging entrepreneurship and growing the biotech business. The focus is on how we bring in the investments into the sector and on developing spin-offs. Another important feature is about global partnering and about really making sure that we make the whole environment very conducive to global clinical services and research. You know that we are trying to make India the preferred hub for clinical development and for R&D. So the emphasis is on creating the right infrastructure and academic excellence. It also talks about creating a strong bond between the industry and the academia. We require researchers, investigators, and scientists and this whole exercise is about employment, talent creation and talent management. I believe it is very well thought out document. Dr Cyrus S Poonawalla: A single window clearance mechanism is proposed to be put in place. We have been hearing about this for years, but this is yet to become a reality. This is the most important aspect, which should be first emphasized. It takes months, may be some times years, to get a product through to the market. It is very disheartening when things are getting delayed. It's even more disappointing for the small entrepreneurs as their capital is blocked and they cannot even move on to the next project. I think the regulator has to keep this reality in mind and see to that the clearance mechanism is made very effective. I believe there is also a fund that has been created for biotechnology. This should be rationalized and distributed to smaller entrepreneurs promptly, as they need the funds to stand up. They should not get stuck in procedural issues. The funding should be timely. So I think these are the two things of the policy, which are very welcome, but their implementation will really be the keynote for the policy to succeed.   Prof. Samir K Brahmachari: One single element of the whole policy I insist on is 50 colleges. I have been talking to Dr Bhan identifying colleges and empowering them and I am glad to see that it has come true. I grew up in Bangalore in an academic environment and I realize that our weakness is in our ability to take the government funds and optimally utilize it. The funds can be 100 percent utilized in collaboration with the private sector. I was one among the first few people to have created a private-public partnership model and have seen the outcome of such a model. The private-public partnership has been very well documented. The government can put in a lot of money but the energy of the private sector and the small amount of flexibility the private sector brings in is very important. We don't have enough capacity to absorb the money that the government has given. Further, people should be empowered to innovate. The challenge is how do we empower and listen to young people when they are saying something absurd and out of the box. If we cannot hear them and implement their suggestions, then, however good a policy it may be, it would remain frozen. So if we have to target any innovative space, we have to be ready to take the risk and face recognized failures. The policy framework should allow people to fail and acknowledge failure. The policy has all the elements, but the challenge will be in implementing it. Dr KK Narayanan: It has been five years of consultation before this policy got approved. A lot of people have worked together and Dr Bhan and his colleagues have put together a good policy and we are not disappointed. Dr Brahmachari has unambiguously underlined the importance of private sectors as partners in nation building. The policy not only talks about public-private partnership but also makes a very clean statement that 30 percent of the total research grants from the DBT will go to public-private partnership projects. Further the policy underlines the importance of development of human resources. There are a number of initiatives that have been listed which actually focus on improving the quantity and quality of the human resource. There are several other wonderful things in this policy. The telecom or the IT policy succeeded in growing the sector because people put their money where there mouth was and that's coming back to what Dr Poonawalla just now said--we need to walk the talk, we need to put the money where the mouth is and that's going to be the key. Another important and encouraging factor in this policy statement which needs to be commended is the paragraph that talks about key performance indicator. It means that the people who drafted this policy and who have passed it have taken upon themselves the responsibility to make the policy succeed. We need to see so many more companies coming into this country and being profitable and prosperous. These are all key performance indicators. We are used to these terms only in the private sector. It is so refreshing to see it in a government policy and I don't know any other policy or document, which takes on this responsibility. If that does not happen, we at least we know what we should be doing differently to make it a success. So these are some of the very positive things about this policy. Now the important thing is to walk the talk. Dr S Natesh: The major issue was bringing in the synergy to the sector by combining the variegated potential of different groups together. Towards this end, we have tried to take a whole lot of measures that went into making this policy. What we have done through this policy is that we have made our intent very clear. Therefore we look forward to creative ideas from the industry as to how should we spend that money. We would want the industry to come up with suggestions. One of the things that we would do is work closely with the industry and establish some more finishing schools for post graduate students and get them exposed to the industry. We are trying to attract world class scientists from abroad. We are also looking at mobility of scientists between academia and industry where we would support the salary of the scientists when they work for the industry and also may pay for the services of the substitute he or she is having when he goes to the industry and works there. These are the measures that should go a long way. We have also thought of joint chairs between industry and DBT where 50 percent of the money will be spent for industry work. Then we propose a new program--a shared cost partnership with the industry. The purity of this would be that irrespective of science, industry can partner with them and the money thus given by the public sector would be utilized for two purposes. One is that industry is not investing too much on advanced technologies so we would help the industries in investing in the technologies. The second thing would be to meet the unmet needs of the country for national emergencies such as diseases, droughts and natural calamities where there is a social impact. We strongly recommend that industry set up R&D foundations so that DBT can invest in those foundations. And treat these foundations like any public sector partner. These R&D foundations should become a source to train skilled workforce for the industry as well provide future leadership. To promote and manage all these, we proposed setting up a Biotechnology Industry Research Assistance Transcript which will work as a watch dog. These are all suggestions to promote further discussions. We are serious about all these and we hope that the industry will also look at it very seriously. Do not see this as a banking assistance program. We keep the window open for the next three months and it would be best if BioSpectrum could manage to convey the suggestions from the industry to us.   ]]> <![CDATA[Novel Antibody, Several Firsts]]> https://biospectrumindia.com/news/95/1706/novel-antibody-several-firsts.html https://biospectrumindia.com/news/95/1706/novel-antibody-several-firsts.html Thu, 13 Dec 2007 16:19:00 +0530 Novel Antibody Novel Antibody, Several Firsts BIOMAb-EGFR, a therapeutic monoclonal antibody-based drug for treating solid tumors of epithelial origin such as head and neck cancers, clinically developed in India is the first by an Indian company. And patients in India are believed to be the first in the world to have access to a novel product. Rohit (name changed), a Bangalorean, was recently detected with an initial stage of neck cancer. He was then prescribed BIOMAb, a made-in-India product, which costs around Rs 40,000. He is being administered the drug every once in a week with 30 minutes infusion since the last two months. Rohit has not been getting any severe form of side effects as it is associated with other therapies and hopes to recover soon. BIOMAb is a new class therapy from Biocon for treating head and neck cancer and promises a lot of hope for the patients in India. Rohit and several other patients now have access to BIOMAb, which is cost-effective and affordable. Globally there are very few monoclonal antibodies that have been approved and a majority of those are from companies in the US. Monoclonal antibodies, which are very complex large molecules, unlike aspirin, need a lot of scientific expertise to manufacture, characterize and even apply them in a clinical setting. These are not the kind of drugs that one goes to the pharmacy and picks up. Typically, they are applied in tertiary care settings where one goes to a specialist clinician who then prescribes this drug. It is fortunate that we have a molecule--BIOMAb EGFR from Biocon--that has been approved for use in India and is available for the Indian patients ahead of the patients in the rest of the world for managing head and neck cancer. BIOMAb EGFR is a humanized antibody, a complex molecule approximately 1.5 lakh dalton in molecular weight. It targets a molecule called Epidermal Growth Factor Receptor (EGFR) that is present on epithelial cells. EGFR is present at particularly high levels on tumorous epithelial cells. When the BIOMAb EGFR binds this receptor, it helps to kill the tumor. According to Biocon, the clinical trials have indicated that patients respond extremely well to BIOMAb EGFR given in combination with traditional chemotherapy and radiotherapy. These antibodies have complex secondary and tertiary structure that enable them to specifically target cancer cells as opposed to all cells; therefore the systemic toxicity is often very minimal. So one can almost get into a specialist clinic, get an infusion in an outpatient setting and walk away. This is not like typical chemotherapy where one has systemic toxicity because the drug targets specific receptors or signals in the body that causes the disease. "This drug is also in clinical trials in Europe. They have very promising results in a very deadly form of brain cancer called pontine glioma in children. Many other trials are going around the world. There is a global meeting that occurs every once in a while where investigators meet. Here clinicians came from all over the world, including our clinicians, to share their experience about how this drug has worked," explained Dr Harish Iyer, head, R&D, Biocon. BioMAb EGFR Nimotuzumab The last few years have witnessed the approval of a number of chemotherapeutics and immunotherapeutics including various antibody based products for the clinical management of diverse cancers. The first MAb approved for cancer was rituximab, a chimaeric IgG1 kappa MAb, indicated for the treatment of lowgrade or follicular CD20+ non-Hodgkin's lymphoma (NHL) and is sold as MabThera/Rituxan by Biogen Idec, Genentech and Roche. The other monoclonal antibody from the same class is Cituximab from Merck which is also being widely prescribed for cancer patients in India. The number of cancer cases is alarmingly high in India, about 100 per lakh, and the highest rates of head and neck cancers are reported in South Asian countries, The Indian sub-continent accounts for one-third of the world burden of head and neck cancers. BioMAb-EGFR is available in a pack with a unit carton of four 10 ml vials each containing 50 mg. Development of BIOMAb was a joint venture between Biocon and the Centre of Molecular Immunology (CIM), Cuba. CIM did the molecule research for the drug and also provided the initial human data. The drug is the first of its kind to be clinically developed in India and is the first anti-EGFR humanised monoclonal antibody for cancer and would be made available commercially anywhere in the world. Kiran Mazumdar Shaw, chairman and managing director, Biocon, said, "It was interesting to bring the first true proprietary immunotherapeutics to the Indian market. Biomab-EGFR is competitively priced, making cancer treatment more affordable. It has the potential of be a billion-dollar product. Importantly, in terms of affordability and quality we score much higher than the multinationals and our mission is to bring innovative drug at an affordable price." "We are today the largest selling monoclonal antibody in the country and we aim to be the leader in cancer care. The product has already been launched in Pakistan and Sri Lanka a couple of months back" -Rakesh Bamzai, head, marketing, Biocon She added, "The company made an investment of approximately Rs 150 crore on BIOMAb EGFR including the clinical development programs and the manufacturing facility. The investment in the clinical development program is still in progress for other cancers and each clinical trial is costing around Rs 15-20 crore." The product has shown consistent response in clinical trials initiated both in India and globally and is produced at its manufacturing facility at Biocon Park. BioMAb-EGFR is indicated for use in combination with radiation therapy or chemotherapy. The pathbreaking monoclonal antibody, BioMAb EGFR was granted regulatory marketing and manufacturing approval and was launched in India in September 2006. The company is expecting it to get approved in Europe by next year. Commenting on BIOMAb EGFR's success, Rakesh Bamzai, head, marketing, Biocon, said, "We are today the largest selling monoclonal antibody in the country and we aim to be the leader in cancer care. The product has already been launched in Pakistan and Sri Lanka a couple of months back." "Our manufacturing rights are more compared to our marketing rights. We have at present the marketing rights for almost 25 countries and we will be marketing the product across these markets based on the regulatory approvals. We are looking at marketing the drug to these markets through alliance partners and distribution channels," he added. The total number of registered patients for BIOMAb is almost 1,000 in India which is much higher than any other similar product from the multinational companies, according to Bamzai. The drug indicated for head and neck cancer is also being studied in global clinical trials for colorectal, lung cancer, glioma (brain cancer) and pancreatic cancers. "My main objective was to see how to get into innovation and new drugs. The question then was how to develop the products as developing new products or medicines involved a very high risk component. Further, as there was little access to new drug development in India then, we had to look outside of India for any kind of innovation. Antibodies were a new class of therapies and Cuba was doing R&D and innovation in this area. Since we needed to be innovative, we took the risk of partnering with CIM as we believed in the cutting edge work being done there and they had human data. We joined hands for developing the product, invested in the clinical development, invested in the technology for antibody production and finally brought it to the Indian market at a very affordable price. Cancer is a very challenging area. Most of the cancer drugs are not billion-dollar drugs. Because not all drugs work for all cancers, there are a fewer number of patients. Therefore, it is a high-price low-volume segment". -Kiran Mazumdar Shaw, chairman and managing director, Biocon "When we have any new drug or any molecule to be used for patients the first thing we need to look at is the safety issue and then the efficacy. BioMAb EGFR from Biocon is a humanized molecule that belongs to the category of Nimotuzimab. Now every drug has some side effects but the degree of side effect varies. So, any treatment that we prescribe to the patients should not be worse than what they are suffering from. The most common forms of side effects, which occur with this category of drugs, are skin rashes and diarrhoea. With this drug, this side effect has been found to be less than 2 percent in patients. It doesn't need any extra treatment and is very safe". -Dr K Govind Babu, medical oncologist, Curie Centre of Oncology "The major challenge was that nobody had done it before in India" -Dr Harish Iyer, head, R&D, Biocon Biocon's BIOMAb EGFR is a novel molecule that has been developed for the first time in India. Dr Harish Iyer, head, R&D, Biocon, shares with BioSpectrum the trials and tribulations that Biocon underwent in developing this product. How did you come up with the idea for developing BIOMAb EGFR? During one of her visits to Cuba, Kiran Mazumdar-Shaw found scientists at the Centre of Molecular Immunology (CIM) doing very interesting work with antibodies. Kiran always focuses on being at the cutting edge of technology. And since they had some human data available, we took the decision to make the connection and that got us started on this project. This was also an opportunity to make very advanced therapies available to patients in India. This is one of my personal motivations to undertake this work and I believe many of our employees feel this way as well. Before BIOMAb EGFR, all antibodies in the Indian market were imported. So they are very expensive. Now that India is developing strong indigenous capabilities, you can think about how to make it available to the patients at a more affordable price. Which are the other companies in this space? There are very few companies in this segment as it is a complex and expensive business. In India, we have Dr Reddy's, but most other companies are global players like Amgen, Bristol-Myers Squibb, Genentech, Johnson & Johnson, and Roche. What are the advantages and disadvantages of the product? There are lots of advantages including a significant survival benefit. It is a very good drug. The side effects are very minimal as it is a highly targeted immunotherapy. The systemic toxicity is minimal with no serious incidence of rashes. I cannot really think of any disadvantages. What were the challenges that you faced in the development process? The major challenge was that nobody had done it before in India. We were blazing a new trail at every step-on process development, characterization, manufacturing, clinical development. Nobody in India has done trials in a novel antibody, while there was very little experience outside. We had Indian doctors using the therapy for the first time and not having done it elsewhere. We had developed a lot of methods internally to characterize the molecule and understand its mechanism of action. How many years did it take to develop BIOMAb EGFR? When we started we had some preliminary data from Cuba. Once we set up the joint venture, it took us about five years (the product was approved in 2006) to finally come out with it. Now, we manufacture the product in Bangalore and market it in India and other countries. BIOMAb EGFR is also being developed in other countries including Canada, China, Germany, and Japan. Can you briefly tell us about your team that developed the product here? I was a part of the team that helped with the process and analytical development and absorbing the technologies from CIM. We had a manufacturing, quality and regulatory team headed by Srinivasan Raman, Tara Jayaram and Sriram Akundi. The clinical trials were done by Arvind Atignal and his team from Clinigene. Rakesh Bamzai was looking after the business development and marketing. Of course, we had consultations with our partners in Cuba and the two of the key people from Cuban side were Dr Patricia Sierra and Dr Joaquin Villan who are both stationed here in Bangalore. After the success of this drug, what is the next step forward? We have a pipeline of very exciting products. Our next antibody in clinical trials is T-cell inhibitor that we are testing in RA and is showing promise in other autoimmune disease. We also have an antibody that blocks TNF-alpha and another that target lymphomas by depleting B-cells (by targeting CD20). So, it is a very rich pipeline that has the potential to change the pharmaceutical landscape within India for many serious diseases. Jahanara Parveen ]]> <![CDATA[Architect of Modern Biology]]> https://biospectrumindia.com/news/95/1809/architect-of-modern-biology.html https://biospectrumindia.com/news/95/1809/architect-of-modern-biology.html Thu, 13 Dec 2007 16:10:00 +0530 Architect of Modern Biology Architect of Modern Biology He is widely regarded as the architect of modern biology and biotechnology in India. Educated at Varanasi and Lucknow, he is one of the youngest to have obtained a PhD at the age of 21 and produced four books and has over 125 major scientific publications and over 400 articles and other write-ups in reputed publications all over the world. He has been advisor to several well-known pharmaceutical and other industries, chairman of three companies and member of the Board of many others. He has been a member or chairman of over 125 major national and international standing committees and has been connected with numerous scientific, social and cultural organizations. He has been the man behind setting up the world class Centre for Cellular and Molecular Biology (CCMB), Hyderabad. A recipient of over 100 national and international honors and awards including the Padma Bhushan, the Legion d'Honneur and the National Citizens Award (India), Dr Bhargava, who has turned 80, is being conferred the BioSpectrum Life Time Achievement for his over four decades of untiring contributions to biotech development in India. Dr Pushpa M Bhargava Founder Director of the Centre for Cellular and Molecular Biology (CCMB) and former vice chairman of the National Knowledge Commission Started his own private consultancy Anveshna, after retirement from CCMB PM Bhargava is chairman of The Medically Aware and Responsible Citizens of Hyderabad, the Sambhavna Trust, Bhopal, and the Basic Research, Education and Development Society (BREAD), New Delhi Recipient of over 100 national and international honours and awards including the Padma Bhushan and the Legion d'Honneur. Dr PM Bhargava is currently the chairman of The Medically Aware and Responsible Citizens of Hyderabad, the Sambhavna Trust, Bhopal, and the Basic Research, Education and Development Society (BREAD), New Delhi Dr Pushpa Mittra Bhargava in the 1960s was proud of being called a biochemist. After biochemistry came molecular biology and cell biology. So when he was asked to set up a biotech center of excellence, he gave it the name Centre of Cellular and Molecular Biology. Today, he hates being called either as everything according to Bhargava is integrated. He prefers the term biologist. He is in fact one of the early champions of biotech in the country. His first encounter of sort with the idea of biotechnology intellectually was when he wrote the review of one of the most scientifically renowned papers on the uptake of non viral nucleic acids by plant and animal cells. That was what genetic engineering was about. This was written in 1971. It was a long review published in the Academic Press Book. He was also among the first few people to have coined the word Genetic Engineering. In 1973, he wrote a syndicated article in which he used this term. "The reason why I didn't remember this was because the article was unfortunately published in Motherland, a RSS journal. It was a syndicated one, so I had no control over it. The word was actually used six months before my article. There was another person who used the same term," remembers Dr Bhargava. So they were the first two to use the term genetic engineering in 1973. Dr Bhargava is one of the few scientists, who has had the chance to have a ringside view of the developments in modern biology. He had fought two battles for the biotech industry in India. One was initiating the setting up of a separate department for biotechnology in the ministry of science and technology. And the other being setting up a world class center-of-excellence-Centre of Cellular and Molecular Biology (CCMB)-in Hyderabad. Incidentally, he is also believed to be the first person to use the word biotechnology in public. In 1978-79, he suggested the setting up of a separate department for biotechnology. An apex body came first and then finally the Department of Biotechnology (DBT) was set up in 1986. He had wanted DBT to focus on developing the biotech industry in the country and encourage commercialization of publicly funded research work. But DBT in the initial years focused on academic research much to his disappointment. He is happy that DBT is now very industry friendly. The other major contribution of Dr Bhargava is CCMB, which is today not only India's best laboratories, but a world class institute. Everyday was a challenge for Dr Bhargava while setting up the institute. He created a world class infrastructure, recruited quality people, and set up best practices and a very conducive environment. All these were unheard then and he fought against all the established norms to create such an institute. And more so it was built at a cost of Rs 12.5 crore against an estimate of Rs 67 crore. He is an upright and outspoken person. He does not even have a house of his own. He still lives in a rented house. "We have three very valuable items. One is our documents, almost quarter of million letters. In fact some of our letters people ask if they can put it in public display. The second is the collection of gifted books and the third gifted paintings." He is probably one among the only few people in the world to have letters written to him by leading scientists from the globe. All of his documents, gifted books and paintings have been given to a foundation. Though a scientist, Dr Bhargava is found of art and reading. He believes in making a correlation and learning everyday. He loved maths. But went on to do PhD in chemistry and then biology. He has learnt business planning, how to read a balance sheet and can write a business plan today. He has been on the board of several companies and has also advised many start-ups. Even at the age of 80, he is always on the move. In the last six years, he has been out of Hyderabad for minimum of 130-160 days in a year and these trips combined several things-the lectures that he deliver has been 76 in 2000, 78 in 2001, 76 in 2002, 63 in 2003, 51 in 2004 and 57 in 2005 and 55 in 2006. And he sees all this as a gain by being around with people. Though he is a little disappointed that large corporate houses have not entered biotech businesses as they should have he is very hopeful that the private sector would make significant strides in the biotech development. A modern biologist "I was born in a middle class family. My father was a medical doctor. I never went to school. My parents said they tried to get me into a school but no school was ready to take me. When I was 10 years old, my family shifted to Varanasi. My grandfather took me to the Krishnamurti Foundation India school there to get me admitted to sixth standard. But the school admitted me to the ninth class. At 18 years, I did my MSc and at the age of 21 I did my PhD and my first scientific paper was published when I was 19. I decided to do MSc in chemistry which I disliked most. Mathematics was my first love and I did all the university mathematics except for integral calculus at the age of 13 or 14 on my own. Yet I was not excited as we were taught mathematics as a set of operations. My next favorite subject was physics, but I didn't take that too. So I thought I would do my masters degree in chemistry and then decide what to do. I did enjoy doing my PhD in chemistry and also set a record of doing PhD at the age of 21 in 1949. I had 14 major papers at the age of 23. However in 1953, I decided to leave chemistry as I used to read a lot of books on anthropology, sociology, political science and that was fantastic. While doing so I saw connections between chemistry and biology and was very excited. But I had never studied biology in school. So I decided to make this paradigm shift by going abroad. The shift to biology was intellectually very exhaustive. Twenty five of my personal friends have won Nobel prizes and I am probably the only one who has had a ringside view of every biotechnology development". "The greatest excitement in life is to seek new correlations" -Dr Pushpa M Bhargava What are your comments on evolution of biotech agenda in the country? I was probably the first person to use the term biotechnology in public. In 1978-79 my suggestion was that we must set up a separate department for biotechnology. A high power meeting was called by the former Union minister of state for science and technology and scientific adviser to the former prime minster Rajiv Gandhi, MGK Menon, to discuss what to do. The decision was to set up an apex body for biotechnology. My idea was that we should invest in genetic engineering for microbes, enzyme tech, immunoltechnology, tissue culture, increasing photosynthesis, alcohol production from natural resources, energy plantation. So there were eight areas that I suggested. A few days after this meeting, the scientific advisory committee put the recommendation before Prof. MS Swaminathan, who was chairing it. The committee decided to set up a national biotechnology board (NBTB) as Prof. Swaminathan left for IARI. I was disappointed as I was pushing for a separate department. The NBTB was set up and the question was who will take charge of it? I suggested Dr S Ramachandran's name. NBTB was to be serviced by the DST. It was given a budget of somewhere around Rs 3-4 crore. The idea was that all the other agencies like ICMR, ICAR, and CSIR would contribute. I should also tell you that the science policy is a very dirty policy. I actually had no support from the scientific community. I wanted a department not for myself but for the country. In 1985, I wrote a letter to prime minister Rajiv Gandhi and that did the trick. In February 1986, the department was announced, and my dream came true. The DBT was to be set up to be involved in commercialization. I wanted a department of biotechnology and not biology. I wanted the government to set up the department in public-private partnership structure. I was very disappointed as no action was taken. I put my bet on the private sector and I must say that it has been very satisfying for me. The Indian private sector has grown, thanks to people like Varaprasad Reddy and Kiran Mazumdar-Shaw. What was your experience with Sun Pharma? In 1991, Dilip Shanghvi invited me to his campus. I talked to him about R&D and he talked to me about business and how business is run. Finally Dilip said we have an R&D group and we want to bring it to Baroda. Then he showed us a place. Next day he called up and said he was planning to buy one floor of 5,000 sft. I advised him to buy the whole building and he did that, despite not having the budget. Then we designed the entire center and today Sun Pharma is a Rs 2,000-crore company. I learnt a lot from him. He was a commerce graduate, but he took the trouble to understand science. My trouble to understand other areas is far less significant than his trouble to understand science. So I could speak to him as a professional and it was a wonderful experience. Once one's mind is spoken and one's interest is strived by self interest, there is so much that one can gain. My problem with many people is that their minds are closed. They just don't look outside. Are the scientists-turned-entrepreneurs more courageous in the Indian environment? There are a very few scientists-turned-entrepreneurs. But the march is good. Kiran is one and we have a few small ones here at Hyderabad. What excites you? The greatest excitement in life is to seek new correlations. That's where the fun is. And I have always enjoyed finding the meaning of other people's work that they couldn't find and that's what a good scientist does. He sees a problem which nobody else has seen. In fact when I look at the international scientific community I had certainly the great privilege of being a part of it. This is the great fun in the sense that where you are not constantly talking about your work but talking about others' work. Being a good scientist you prefer to listen to other scientists rather than talk about your work and that becomes a battle. Do you find time to read now? That's a very interesting question. I have taught myself rapid reading. I can scan through a write-up in 10 seconds. N Suresh & Ch. Srinivas Rao     ]]> <![CDATA[Patents in Europe are going to become less expensive]]> https://biospectrumindia.com/news/95/2146/patents-in-europe-are-going-to-become-less-expensive.html https://biospectrumindia.com/news/95/2146/patents-in-europe-are-going-to-become-less-expensive.html Thu, 13 Dec 2007 15:28:00 +0530 New Page 1 Patents in Europe are going to become less expensive The authors are spotted with their team members. After ratification by France, one of the three key states for the Agreement's entry into force, the London Agreement can now come into effect as early as the first half of 2008 The London Agreement will be a major step towards cheaper European patents as patent holders will be spared the high costs relating to the translation of European patents One of the major considerations for any biotech or pharmaceutical company building up a position in Europe are the costs of validating the European patent in the various contracting states of the European Patent Convention (EPC). While the costs of prosecution, i.e. handling the European patent application and pushing it through to grant at the European Patent Office (EPO) are acceptable, the costs for the subsequent validation phase can be considerably higher, mainly due to the enormous costs for doing translations. After grant, a European patent is only in effect in those states in which it has been validated. Most of the EPC contracting states require that for validating the patent in their territory, the patent needs to be translated in the respective official language of that particular state (e.g. Italian, Spanish, German, English, Greek etc.). For validating the patent in all 32 EPC contracting states, a translation in 22 official languages is still necessary, which can cause costs of several 10000 Euros. In order to reduce these high translation costs, the "London Agreement" was made in the year 2000. According to this agreement, each EPC contracting state, which has one of the official languages of the EPO (German, English, French) as its own official language waives the translation requirement altogether. That means that if the patent is written in English, it does not have to be translated into German and French in states that have German or French as their official language. Any EPC contracting state which is a party to the "London Agreement" and has neither German, nor French, nor English as its official language, has to select one of these languages and accept a translation in this selected language, rather than requiring a full translation in its own national language. However, such states can still require to have a translation of the patent claims made in the national language. As an example, if Sweden selects English and the patent was written in English, no translation of the specification is required anymore; only the claims need to be translated in the Swedish language. All states which are a party of the London Agreement still retain the right to request a complete translation of the patent in case a legal dispute arises, e.g. national infringement proceedings etc. The London Agreement has not entered into force yet, because France had not ratified the agreement. However, on October 9, 2007, the French senate has ratified the London Agreement, so that the ratification document can now be deposited with the German government in Berlin, as required by Article 3 of the Agreement. One can expect that this formal act is being done very soon. According to Article 6 of the London Agreement, the Agreement enters into force on the first day of the fourth month after deposition of the last ratification document. At the time of writing this article, this date can still not exactly be given, but it can be expected that the Agreement will probably enter into force in the course of 2008. Obviously, this will have an enormous impact on reducing the costs of a European patent, since the costs for translations are cut down to a large extent. For companies active in rapidly evolving and highly competitive fields of technology, such as the life sciences sector and especially biotech, this should be a real incentive to think about having more patent applications in Europe. We have described the various options on how to do that in the October 2007 issue of BioSpectrum. The Agreement will be applicable to all European patents, which will be granted after the Agreement has entered into force. In our law firm, we have taken steps to delay the prosecution of European patent applications that are close to grant, so that they will fall under the London Agreement in 2008. Dr Ralf D Kirsch & Dr Thomas Westphal Patent Attorneys and Attorney at Law Hamburg, Germany Dr Ralf D Kirsch and Dr Thomas Westphal are both patent attorneys and partners in the IP law firm GLAWE DELFS MOLL in Germany (Hamburg, Munich, www.glawe.de). Dr Ralf D Kirsch studied biology and went into research in molecular biology, immunology and biochemistry at the University of Cambridge, UK, and at the Max-Delbrueck-Centre for Molecular Medicine in Berlin, Germany (kirsch@glawe.de). Dr Thomas Westphal studied biology and spent years in research in genetics, molecular biology and biochemistry at the Lomonossow University in Moscow and at the Martin Luther University in Halle, Germany.   ]]> <![CDATA[Bangalore Bio 2008 to focus on global partnerships]]> https://biospectrumindia.com/news/95/7436/bangalore-bio-2008-to-focus-on-global-partnerships.html https://biospectrumindia.com/news/95/7436/bangalore-bio-2008-to-focus-on-global-partnerships.html Thu, 13 Dec 2007 15:23:00 +0530 New Page 1 Bangalore Bio 2008 to focus on global partnerships From left to right: Jagdish Patankar, exhibition manager, MM Activ, MN Vidyashankar, secretary, IT & BT, government of Karnataka, Kiran Mazumdar-Shaw, chairperson of Karnataka Vision Group on Biotechnology, and Dr KK Narayanan, president, ABLE, releasing the brochure of Bangalore Bio 2008 at the curtain raiser of the event in Bangalore. The eighth edition of Bangalore Bio, the flagship event promoted by the Government of Karnataka and Karnataka Vision Group on Biotechnology, will take place on April 24-26, 2008 at the Bangalore International Exhibition Center, Bangalore. Set to be a bigger event this time with "Global Partnership" as its theme, Bangalore Bio 2008 will be a unique platform for bringing together national and international participants from the biotechnology, pharmaceutical, educational and financial sectors to interact, network, showcase innovations in products and services, to transform concepts into markets, explore investments and business opportunities through its trade show, technical sessions, international conference, business forum, CEO conclave, poster session and the newly added biopartnering forum. This year bioexcellence awards have been instituted to recognize the contribution of eminent Padma awardees from the field of science and technology and outstanding achievers. Awards for the best stalls will also be presented to the exhibitors for innovative stall designs and creative display of products and services. Speaking at the curtain raiser event of Bangalore Bio 2008, Dr Kiran Mazumdar-Shaw, chairperson of Karnataka Vision Group on Biotechnology, and CMD, Biocon, said, "The biotech sector worldwide is about partnering. In a dynamic business environment, the biotechnology industry recognizes the importance of international partnerships and their vital role in competing, growing and creating value on a global scale. India has attracted a lot of global attention for the potential it has and the year 2008 will again demonstrate our leadership in biotechnology. Bangalore Bio will bring together the stakeholders of the industry to drive growth, develop innovative pipelines to enter deals for commercialization, overcome capital constraints and capitalize on core strengths for achieving global competitiveness." MN Vidyashankar, secretary, IT, BT, Science and Technology, Government of Karnataka, said, "The success of biotechnology is vital for the future of our state and country. We started off well and we plan to build rapidly on our successes. A lot of research and innovation is being done by small and mid-sized biotech firms in the country. Bangalore Bio 2008 will provide a platform for emerging technologies and companies to showcase their research and explore global tie-ups." This year Australia is all set to play an important role in Bangalore Bio 2008 as a partner country with a large delegation. With focus on innovation, the main conference session at Bangalore Bio 2008 will attract some of the leading scientists and industry stalwarts from across the globe. A technical papers section would be introduced this time to encourage and showcase tremendous research and development activities happening across academia, R&D institutes and emerging biotech companies. For the third time in row, April 26 has been dedicated as Agribiotech Day at Bangalore Bio 2008 to showcase India's experience and progress in agribiotechnology. The day will focus on current trends of agribiotechnology. The CEO conclave will witness a high power meeting point of various professionals with a key industry stalwart delivering the "Vision Talk" at the conclave. This year too, Bangalore Bio will host the poster session in conjunction with the international conference. Industry visits will also be organized for interested delegates on first-come first serve basis. The delegates will be taken to two core biotechnology â€“ biopharma and bioagri. The industry visit would include company presentation, management (general and specific techniques), innovation, business processes, good manufacturing practices, health and safety.   ]]> <![CDATA[analytica Anacon India 2007 scores well in all disciplines]]> https://biospectrumindia.com/news/95/1867/analytica-anacon-india-2007-scores-well-in-all-disciplines.html https://biospectrumindia.com/news/95/1867/analytica-anacon-india-2007-scores-well-in-all-disciplines.html Thu, 13 Dec 2007 13:53:00 +0530 New Page 1 analytica Anacon India 2007 scores well in all disciplines Senior members of the IAIA with chief guest, Dr P Rama Rao, a keynote speaker, Dr Venkateshwaralu, at the inaugural function. analytica Anacon India 2007 closed its gates in Hyderabad on November 2, 2007 with some outstanding results: More than 3,000 decision-makers and users, especially from Indian laboratories, came to the two halls at the modern Hitex Center to gather information about the latest equipment, applications and products in the sectors for instrumental analysis, laboratory technology and biotechnology. That is a 17 percent increase over last year. The 142 exhibitors from 14 countries â€“an increase of nearly ten percent â€“ gave the fair top marks for its choice of location, for the trade fair center and for the quality of the visitors. analytica Anacon India 2007 surpassed the expectations of its organizer â€“ Munich Trade Fairs International Group â€“ in all exhibition-related disciplines with increases in the number of exhibitors and the amount of exhibition space, a larger number of visitors, a significant improvement in visitor quality, and the right choice of location. "We were surprised by this outstanding event, and we are very satisfied with the results," said Toshiaki Matsuda, vice chairman of the global marketing committee of JAIMA. "Holding the exhibition at the Hitex Center in Hyderabad â€“ the capital of Andhra Pradesh and fifth largest city in India and the surrounding area already have major centers for the pharmaceuticals industry, fine chemistry and biotechnology sectors, and more are planned â€“ satisfied two of our exhibitors' most important criteria. Add to that IT companies that play a key role in laboratory automation and optimization. The modern trade fair center meets western quality standards, so it satisfies our needs. It has a business atmosphere that was praised by the exhibitors and Indian trade visitors, and it also attracts the international analysis industry to India," summarized Hans-Joachim Heusler, managing director at Munich International Trade Fairs. The majority of the exhibitors at this year's analytica Anacon India, which was held in Hyderabad for the first time ever and just one year after the last exhibition, were of the same opinion. As many as 142 companies from 14 countries â€“ Canada, China, Columbia, France, Germany, India, Italy, Japan, Korea, Spain, Sweden, Switzerland, the US and UAE â€“ had exhibits at analytica Anacon India 2007 (2006: 130 exhibitors from eleven countries â€“ a 9.2 percent increase). Decision-makers from top management analytica Anacon India 2007 was a popular attraction among top managers from Indian laboratories. Exhibitors praised the excellent quality of the visitors who attended the fair, who included a large number of managing directors, upper management and laboratory directors, especially from the pharmaceuticals, fine chemistry and biotechnology sectors. According to Futagami Hiroaki, chief representative of Singapore Representative Office of Eyela, a Japanese manufacturer, the majority of the visitors at his stand were decision-makers and executives from laboratories in the pharma industry as well as a number of representatives from companies that do contract research for international pharma groups. And according to Senya Imamichi, deputy managing director at Shimadzu, upper-level managers with concrete intentions to invest came to Hyderabad from every part of India to see the latest laboratory solutions. Many exhibitors are expecting post-fair business to be good. The 3,037 registered visitors who attended the fair (analytica Anacon India 2006: 2,592 visitors, a 17 percent increase) included decision-makers from throughout India and from industrial centers such as Mumbai, Chennai and Bangalore as well as several international guests from the Arabic and Asian regions. Sumeet Pathare, manager, key accounts at Merck Specialities, said that 80 percent of the visitors at his stand were decision-makers from Hyderabad, and 20 percent were from outside that region. Hyderabad a cluster for user industries All exhibitors agree about the growing importance of the Indian market for instrumental analysis, laboratory technology and biotechnology solutions. And there is no doubt that Hyderabad is already one of the largest clusters for this sector in India. The enormous amount of potential it has to offer becomes apparent when visiting the technology centers located in the greater Hyderabad region. Prior to the fair, Dr Stefan Lamotte, manager, columns and stationary phases at Bischoff Analysentechnik, visited pharmaceuticals companies in and around Hyderabad, all of which had laboratories with state-of-the-art high-tech equipment. Hyderabad â€“ which is also called Pharmabad â€“ is currently establishing itself as a hub for the pharmaceuticals, fine chemistry and biotechnology sectors. It has outstanding prospects for future growth, which means rapidly growing demand for efficient high-tech laboratory technology. The IT sector, which is also important to modern laboratories, and international financial institutions have now relocated to Hyderabad, where they are rapidly expanding. "The opening of the new international airport, which is located near Hitex Center and is scheduled for March 2008, completion of the ring highway and construction of the Metro, which will provide service to the trade fair center, will improve national and international connections as well as the regional traffic infrastructure. These measures will help to get even more exhibitors and visitors into the halls and help more companies move to the area," predicts Hans-Joachim Heusler, commenting on future growth. Indian analysis sector's "Hall of Fame": IAIA celebrates tenth anniversary The vice president of the Indian Analytical Instruments Association (IAIA), S Thyagarajan, was very enthusiastic about the course of the fair and the success of the analytica Anacon Conference: "analytica Anacon India 2007 was perfectly organized, and the Hitex Center in Hyderabad is a world-class venue." The international analytica Anacon Conference accompanied the three-day exhibition and featured 25 lectures on the latest innovations in pharmaceutical analysis, material research, chromatography and mass spectroscopy. A separate lecture panel focused on the latest equipment trends and analysis techniques related to the life science disciplines. Speakers from the US, Europe, Germany, Japan and Singapore followed the invitation of the IAIA and Munich International Trade Fairs to appear in Hyderabad. Keynote addresses were booked to capacity with up to 120 audience members, and the IAIA reported a total of more than 450 conference participants. For the next analytica Anacon Conference, S Thyagarajan is planning to increase the number of events to approximately 40 presentations that will take place in simultaneous panels. According to the vice president of the IAIA, Hyderabad is the preferred location because the exhibition and conference center meets western standards and features the amenities that international businesspeople, key players and the industry's leading speakers expect. The IAIA used this year's analytica Anacon India to celebrate its tenth anniversary on the first evening of the fair. It held a large gala where ten members of the IAIA were honored for their commitment and for their achievements benefiting the analysis industry in India and inducted into the "2007 Hall of Fame". Members were honored in three categories, i.e. for developing and manufacturing high-tech analysis equipment such as modern gas chromatographs, for establishing distribution channels for the sale and service of analysis equipment in India and for their commitment to paving the way for the distribution and use of state-of-the-art analysis techniques in Indian laboratories. The next analytica Anacon India will take place in the autumn of 2009.   ]]> <![CDATA["UFLC will be one of the HPLC market growth facilitators"]]> https://biospectrumindia.com/news/95/1354/uflc-will-be-one-of-the-hplc-market-growth-facilitators.html https://biospectrumindia.com/news/95/1354/uflc-will-be-one-of-the-hplc-market-growth-facilitators.html Thu, 13 Dec 2007 13:50:00 +0530 New Page 1 "UFLC will be one of the HPLC market growth facilitators" Senya Imamichi joined Shimadzu in 1984 as a R&D chemist for HPLC product line and then gradually shouldered responsibilities of product manager at Shimadzu Singapore, marketing manager in Japan and so on from where there has been no looking back. Today as the deputy managing director of Shimadzu Analytical (India), Imamichi San is based at Mumbai and takes care of the analytical instruments business in India. Imamichi San shares with BioSpectrum some of the key focus areas of Shimadzu in India. You became the deputy managing director of Shimadzu India about six months back. What do you think of the Indian market? India offers tremendous opportunities for Shimadzu. We have plans to take full advantage of this dynamic market situation. We have distributors in India who are with us for more than 25 years. Shimadzu's approach is to support customers with innovative solutions to their growing needs. Shimadzu set up a customer support center last year. How has this helped the customers? Shimadzu has set up a customer support center in Mumbai to show Shimadzu's commitment to the customer and to provide additional support to our distributors. The customer support center will provide training on different instruments to the customers. We conduct regular training program on different instruments. In the last one year, a number of customers have attended these training programs. We have already brought out the 2008 training calendar. As per this, we plan to offer a number of courses next year. We are also helping the customer for method development. For instance, we have analyzed a number of samples of the customer with our Prominence UFLC and shown the advantage Shimadzu Prominence UFLC offers over the conventional HPLC. Shimadzu Prominence HPLC could be easily upgraded on site to UFLC by customers. Many of these customers whose samples we have analyzed are satisfied with our approach and have ordered UFLC system from us. Do you think that the market for UFLC will improve growth of HPLC market? The instrument companies are continuously finding solution to meet the customer's productivity. UFLC is one such approach. This can be achieved with an elevated temperature or increased pressure. Today customers are encouraging both the approaches. Anyhow, UFLC will be one of the HPLC market growth facilitator. Which segment of customers does Shimadzu target for its HPLCs? Like every other vendors of HPLC, Shimadzu has to target the pharmaceutical market, which has highest market requirement with continued growth for this segment only. We have brought out an integrated fully automated HPLC system called LC-2010HT. This model was well received by almost all major pharmaceuticals companies in India today. We have close to 1,800 installations. What about the other models you have like Prominence? Prominence was launched two years back, which has specs and performance that have created a benchmark in the industry. Prominence was well received in the market. We have already crossed 1,000 installations Is it true that Shimadzu is covering low-end market? I was surprised with this statement. I have seen references to this in your magazine. I have never seen the market classification as high-end, middle-end or low-end. Indian customers are very intelligent customers and they are competing against the global market. They would like to have instruments with state-of-the-art design and performance. I do not think Indian customers will expect any downgraded versions. Does it mean that Shimadzu will not bring out a more economical version? No, not at all. We are looking at a different market segment. For instance, our latest strategy is to tie up with Waters on Empower connectivity with our Prominence system. Can you tell us something more about the Empower connectivity? Shimadzu and Waters have signed an agreement couple of months back that facilitates Empower software to seamlessly connect and control with Shimadzu HPLC. This has been a request from many customers in India and by this connectivity, we are confident of gaining more space in laboratory. What are your immediate plans for the pharmaceutical industry? Shimadzu is arranging Asia Pharma Summit 2007 at Singapore on December 6, 2007. About 30 professionals are invited from India to join this conference and 30 more will join from other Asian countries. This Pharma Summit will be attended by Shigehiko Hattori san, CEO and president of Shimadzu Corporation, Japan. Dr MD Nair, pharma consultant in India, will deliver the keynote address. There are speakers from the US, Europe and Japan.   ]]> <![CDATA[HPLC market in India growing]]> https://biospectrumindia.com/news/95/2472/hplc-market-in-india-growing.html https://biospectrumindia.com/news/95/2472/hplc-market-in-india-growing.html Thu, 13 Dec 2007 13:41:00 +0530 New Page 1 HPLC market in India growing The total HPLC market of India is expected to touch $250 million by the year 2010 S Thyagarajan Chairman, Spinco Biotech and vice president, Indian Analytical Instruments Association It was in 1983 from IIT Chennai, Spinco got the first order for Shimadzu HPLC in India. It took 13 years for Spinco to reach an installation base of 1,000 HPLC systems and four more years to reach the landmark of 2,000 systems by the year 2000. The buoyancy in the market fuelled the HPLC business and in the next seven years 4,000 plus systems were added. In quick succession in two years now, Spinco celebrated 1,000 sets of LC 2010 High Throughput Integrated HPLC and 1,000 sets of modular Prominence HPLC. From the first installation in 1983, Shimadzu has come a long way to cross 6,500+ installations today. This is not just the story of Shimadzu HPLC, in fact, this is the history of the evolution of HPLC market in India over the last 25 years. HPLC, which was once a privileged instrument has transformed today to an indispensable tool for routine applications in every laboratory and in every industry .The change was catalyzed by the liberalization of government policy, growth in the pharmaceutical industry and propelled now by the major advances in instrumentation and column technology. HPLC Chromatography is a process whereby a mixture of materials is separated by forcing it to pass through a medium, which selectively interacts with the different components. As the mixture is carried along through the medium, this selective interaction causes the different components to travel at different rates and thus get separated. Chromatographic techniques are generally identified by the phase of the carrier material used â€“ liquid chromatography, gas chromatography and supercritical fluid chromatography. The origin of liquid chromatography was the studies of Mikhail S Tswett in early 1900 on the separation of leaf pigments using solvents. Although liquid chromatography was the first chromatographic technique developed, it did not become highly useful until the development of HPLC in the seventies. The name HPLC originally referred to the fact that high pressure was needed to generate the flow of solvent in packed columns. However, with continued advances in instrumentation and development of packing materials, the name was changed to high performance liquid chromatography that improved separation, identification, purification and quantification far above the previously known techniques. Computers and automation made HPLC more popular. HPLC in analytical instrument industry The worldwide market for analytical and life science instrumentation for 2006 was estimated to be around $33 billion. The HPLC market including supply of accessories, columns and consumables was the largest segment totaling to $3.2 billion. The compounded annual growth for HPLC is forecasted at 6 percent per year for the next few years bringing estimated revenues to nearly $4 billion by the year 2010. Despite the absence of published data, the Indian market for analytical and life science instrumentation may be estimated to be close to $1000 million for the fiscal year 2006 â€“ 07 in which the share of HPLC and its accessories was $125 million. The market is witnessing strong growth opportunities of 20-25 percent for HPLC in the coming few years and by fiscal year 2010 the total HPLC market of India is expected to grow to $250 million. HPLC product categories HPLC is one of the most dynamic markets in the analytical instrument industry. The market can be segmented into four broad categories - analytical HPLC accounting for 80 percent of the market. Ion chromatography, preparative HPLC and LC MS are the other three segments. Ion chromatography is an off-shoot of general liquid chromatography in which the detector used is conductivity. Ion chromatography was originally developed to analyze inorganic anions and cations, catering initially to the environmental laboratories. However, today it finds wide applications in pharmaceutical and biotechnology laboratories also. The two leading players in this segment are Dionex and Metrohm. Preparative HPLC systems are ideally used for impurity profiling, drug discovery applications, high throughput screening and purification. Besides the three HPLC majors - Agilent, Shimadzu and Waters, preparative HPLC is also offered by Varian, Gilson and Knauer LC MS is the fastest growing technique, thanks to the explosive growth in clinical trials, pharmacokinetics and drug metabolism studies. There are also dedicated systems like gel permeation chromatograph/size exclusion chromatograph for molecular weight distribution studies, amino acid analysis system, 2D HPLC for proteomics research, nano HPLC for LC MS applications. These systems have limited requirements but have a fast growth dynamics today. Fast LC â€“ An upcoming trend Fast LC is indeed the growth engine today contributing to the enhanced growth of analytical HPLC. This technique is gaining wide popularity with a growth rate of 20 percent as per market study. Fast LC applications can be accomplished with either elevated temperatures or increased pressure. It is difficult to say which approach has the technological edge. In 2004, Waters introduced Acquity UPLC â€“ Ultra Performance Liquid Chromatograph using columns packed with particle sizes of 1.7 micron and advances in instrumentation designed to deliver 15,000 psi. Quickly following Waters other vendors have also brought out Fast LCs with similar objective but having compatibility with standard HPLC equipment. Agilent offers RRLC - Rapid Resolution Liquid Chromatograph mentioning that the method dev eloped on a conventional HPLC can be transferred seamlessly to a RRLC. Shimadzu has launched UFLC â€“ Ultra Fast Liquid Chromatograph offering high throughput but without high pressure. Dionex achieves Fast LC with Acclaim Fast column with UltiMate 3000 Intelligent LC. Thermo has launched Accela High Speed LC that has been designed to optimize performance of subâ€“two micron particle columns and upto 15000 psi. The issues to be settled for Fast LC are : sample integrity, sample throughput, sensitivity, method development(optimization) and initial investment and maintenance cost. Market players - HPLC systems The competitive landscape has changed significantly over the years from the Eighties when there were very few players. Today, from Agilent Technologies to Zirchrom Separations, there are close to 100 companies offering HPLC related instrumentation and services. However, the leading three brands in India are Agilent, Shimadzu and Waters. The huge demand for HPLCs and various selection criteria enable robust growth for all players. There has been a paradigm shift in the distribution channels over the last decade. The increased market potential has seen many global players setting up either a direct subsidiary or a joint venture with their erstwhile distributors. Those who have established subsidiaries are: Agilent, Biorad, Beckman â€“ Coulter, GE Healthcare, Perkin Elmer, Sigma Aldrich, Thermo Fisher, Waters and Varian. Dionex and Metrohm have joint ventures. Chemito has OEM arrangement with Knauer. Shimadzu, on the other hand reinforced its successful distribution strategy by establishing customer support centers in India. The other manufacturers who have distributors are: Jasco, Hitachi and Gilson. Market dynamics in India The present Indian market for HPLC and its accessories is $125 million with an estimated growth rate of 20-25 percent per annum. By fiscal year 2010, HPLC business is expected to grow to $250 million. Among the estimated 2000 plus HPLC units supplied every year now, the pharmaceutical market accounts for around 70 percent. Fast LC is expected to have a growth rate of 20 percent. Following Waters other vendors have also brought out Fast LC now. The HPLC columns sold in India will be around 60,000 numbers in 2007, valuing around $15 million. Market players - HPLC detectors Detectors form a major part of the HPLC aftermarket. The detectors equipped with flow through cell were a major breakthrough in the development of modern liquid chromatography. Since sample compounds have differing characteristics several different types of detectors are currently available for HPLC. The detectors are chosen based on the type of analytical information required. The current LC detectors have wide dynamic range normally allowing both analytical and preparative scale runs on the same instrument. They have high sensitivities to detect nanograms of material. The popular detectors are UV-VIS, photo diode array, refractive index, fluorescence, evaporative light scattering, electro chemical, radioactive and MALLS. Diode array detectors can measure the eluate at several different wavelengths simultaneously in addition to the ratio between two extinctions. Using multiple detectors in series such as a UV or ELSD detector in combination with a mass spectrometer is a powerful approach to gain maximum information. Single quad mass spectrometer as a detector for HPLC is gaining popularity. Of late LC-NMR is also being used to get excellent spectra allowing structural elucidation. Indian HPLC market â€“ Past scenario In late Seventies, there were just three vendors for HPLC â€“ Waters represented by Material Research Instruments, DuPont promoted by IR Tech and LDC Milton Roy, distributed by Marsap. Early Eighties brought a few more â€“ Spectra Physics (Toshniwal Instruments), LKB ( SICO ) and Micromeritics (Scientific Aids). In 1983, Shimadzu appointed Spinco as their distributor for HPLC. In the pre-liberalization era the import restrictions were high. A 'Not Manufactured in India' certificate and a 'Duty Exemption Certificate' were mandatory for import â€“ the process for ordering a HPLC was more than a one-year project. With the government liberalizing import in 1991, more industries started ordering HPLCs. The liberalization was followed with gradual reduction in customs duty year after year. It is interesting to look back nearly 25 years later today that other than Shimadzu and Waters, none of the other brands of Eighties exist in the market now. In the case of Waters, the distributors were changed to Salesworth in 1980s and Waters became a direct subsidiary in mid Nineties. Indian HPLC market â€“ Present scenario The Indian pharmaceutical industry with annual sales of over $9 billion, ranks thirteenth in terms of value and fourth in terms of volume globally. It is expanding at a compounded annual growth rate of over 10 percent. This resulted in tremendous increase in the number of quality control, method development, research and drug discovery laboratories. This is the driving force for the HPLC market. The demand is further fuelled by the rise in contract research and bioequivalence business opportunities. The surge in demand for LC MS MS in the Indian market is also a factor for the growth in the HPLC market. The technological advancements with advent of systems for faster analysis have also opened up newer opportunities of growth. Among the estimated 2,000 plus HPLC units supplied every year now, the pharma market accounts for around 70 percent. Proteomics and other life science applications have propelled the growth in academia and biotech industries, accounting for about 10 percent. National Laboratories and other government institutes are also a major segment for HPLC with equal share. There are host of other non-pharma industries like chemical, pesticide, food and beverage, etc who also use HPLC extensively. The demand from independent testing labs is increasing due to continued outsourcing from pharmaceutical industries. These segments will account for the remaining 10 percent share of the market While all the major HPLC manufacturers offer generic detectors like UV-VIS, diode array, refractive index and fluorescence, there are specialized vendors for application specific detectors such as IN-US for radioactive detector; Alltech, Polymer Labs (now Varian) and Sedex for evaporative light scattering; Antec Leyden, BAS & ESA for electro chemical detector, Wyatt for MALLS. Application specific systems built on such special detectors are also offered such as high temperature GPC by Polymer Labs and Viscotek, Alexys LC-EC system by Antec, dynamic light scattering systems by Wyatt. Market players - HPLC columns Columns are the largest segment of HPLC aftermarket, which is rapidly growing, thanks to the continued development of new column technology and applications. Newer stationary phase technology like monoliths, hybrid particles, sub 2-micron particles and extended temperature and pH columns are adding new dimensions. Validation and productivity demands of modern laboratories is the major growth driver. The estimated number of HPLC columns sold in India will be around 60,000 for the year 2007 valuing around $15 million with a growth rate of 25 percent per annum. The major suppliers for columns are: Waters, Thermo, Merck, Agilent, GL Sciences, Phenomenex, Daicel, YMC, Sigma Aldrich, Machery Nagel and Whatman. One of the companies â€“ Flexit Laboratories, Pune (now acquired by Grace Discovery Sciences) is locally manufacturing HPLC columns. In view of the increased demand for chiral columns, Daicel Chemical Industries has recently set up a technical support laboratory at Hyderabad. Strategic corporate developments As it happens in other trades - mergers, acquisitions and strategic co-operation are the order of the day in HPLC business also. For instance, just in the month of October, Thermo Fisher acquired La-Pha-Pack, a company specializing in HPLC vials and also there was a change in ownership at Antec Leyden, a Netherlands based electrochemical systems manufacturer. Another significant development is a collaborative effort between the two major HPLC vendors - Waters and Shimadzu wherein the Empower software will seamlessly control Prominence HPLC. Looking 2007 and beyond To sum up, the present favorable market dynamics in India coupled with the technological advancements in instrumentation will undoubtedly make HPLC the fast growing technique amongst other analytical instruments.   ]]> <![CDATA[Government approves national biotech policy]]> https://biospectrumindia.com/news/95/1903/government-approves-national-biotech-policy.html https://biospectrumindia.com/news/95/1903/government-approves-national-biotech-policy.html Thu, 13 Dec 2007 13:33:00 +0530 New Page 1 Government approves national biotech policy The Union minister for science and technology and earth sciences, Kapil Sibal and Dr MK Bhan, secretary, DBT, announcing the national biotech policy. The much-awaited National Biotechnology Development Strategy has been approved by the Government of India. The strategy is an outcome of a two-year-long nationwide consultation process with multiple stakeholders including ministries concerned, universities, research institutes, private sector, civil society, consumer groups, non-government and voluntary organizations and international bodies. The draft strategy, which was posted on the web, received over 300 comments from all sections of the society. Announcing this, the Union minister for science and technology and earth sciences, Kapil Sibal, said, "Biotechnology is a sunrise sector which requires focused attention and the government has accorded approval for the broad framework of this strategy and the sectors proposed therein. The strategy, while enabling the full utilization of currently available opportunities in manufacturing and services, will lay a strong foundation for discovery and innovation, effectively utilizing novel technology platforms with potential to contribute to long term benefits in agriculture, animal productivity, human health, environmental security and sustainable industrial growth." The key elements of strategy include: A National Biotechnology Regulatory Authority would be set up as an independent, autonomous and professionally led body to provide a single window mechanism for biosafety clearance of genetically modified products and processes. A high-powered Inter-ministerial Committee is to be set up under the chairmanship of secretary, DBT, to effectively coordinate the development of the sector by addressing cross cutting issues. 30 percent of DBT's Budget to be spent on public-private partnership programs. A Biotechnology Industry Partnership Programme (BIPP) for Advanced Technology would be launched The existing Small Business Innovation Research Industry (SBIRI) scheme to promote innovation in SMEs has been a success. Approval has been accorded for the expansion of SBIRI during the 11th Plan. A Biotechnology Industry Research Assistance Council (BIRAC) is to be launched to act as an interface between academic and private sector, particularly SMEs and startups; nurture and catalyze R&D and innovation in biotechnology in the private sector and promote public-private partnerships. In its vision to build world class human capital, the strategy has focused on: Improved and expanded PhD and post-doctoral programs in order to reach the best levels in the Asian region Enhanced quality of masters level and undergraduate level education Promotion of life sciences and biotechnology at undergraduate and masters levels Creation of a translational workforce of high quality to meet short- and mid-term requirements of the country Promoting support to institutions for undergraduate education to achieve 'Star College' status. A new role visualized for autonomous institutions of DBT to promote excellence in R&D. Selected institutions will be financially empowered for promoting excellence in and translational R&D by supporting 'Research Resource Units' in universities and sister institutions through extramural funding. UNESO Regional Centre for Science, Education and Innovation in Biotechnology being established at Faridabad, Haryana, by DBT as part of a Health Science and Technology Cluster. Innovative re-entry packages in terms of fellowships and R&D support will be offered to young and senior scientists of Indian origin to return to Indian laboratories and pursue research on national priorities. In order to create and strengthen world class institutional research capacity in biotechnology, 50 Centers of Excellence (CoEs) to be established during the 11th plan Keeping in view the requirements for translating scientific leads into useful products and processes, a new national initiative will be taken up to build capacity in technology transfer and intellectual property rights. Cluster development is a key strategy to promote innovation and accelerated technology and product development. This new approach has been given the green signal by the government. Four technology clusters are at an advanced stage of planning. Grand challenges of national relevance in the area of agriculture, health, energy and environment will be identified through national and international consultations. Programs will then be launched through multidisciplinary teams, involving public-private partnerships. DBT's proposal to establish new institutional structures, especially in areas very vital to India's progress but in which current strengths are suboptimal has been approved in principle by the government. The institutions, representing a new breed, will be designed with a strong bias for integrating science and translation, and for producing skilled personnel driven towards entrepreneurship. New Legislations A draft bill entitled 'Public Funded R&D (Protection, Utilization and Regulation of Intellectual Property) Bill, 2007' has been prepared through inter-ministerial consultation for promotion of innovation, and would be introduced in the Parliament after obtaining cabinet approval. DNA Profiling Bill to Augment and Transform Forensic Investigation and Criminal Justice Delivery System to be introduced in the Parliament after obtaining Cabinet approval New Translational Initiatives for mass use technologies -- DBT will give special emphasis on translational initiatives to promote mass use technologies. Leveraging international partnerships to achieve global best practices in our S&T efforts for joint IP generation, harmonization of regulatory processes, smooth trans-boundary movement of biological materials, and to access global markets for our products and processes. Note: The details of the strategy are available on Department of Biotechnology's website http://dbtindia.nic.in. ]]> <![CDATA[Scientific community must not yield to Luddites this time]]> https://biospectrumindia.com/news/95/5458/scientific-community-must-not-yield-to-luddites-this-time.html https://biospectrumindia.com/news/95/5458/scientific-community-must-not-yield-to-luddites-this-time.html Thu, 13 Dec 2007 13:28:00 +0530 New Page 1 Scientific community must not yield to Luddites this time Nano biotechnology and synthetic biology can solve many of the intransigent problems of our society. Science and technology development should not be stopped because of political demagogues "DNA neither cares nor knows. DNA just is. And, we dance to its music." -Richard Dawkins It seems it is always the anti-technology activists who are first to cast their stone at any new technology, and scientists come later. Ottawa-based ETC has fired the first salvo demanding stringent regulatory restrictions on the development of nanobiotechnology and synthetic biology. Undoing PR damage is always a hopeless effort afterwards as we have learnt from the GM crops example. As the anti-GMO campaign rages on in India and around the world, the same Luddites are starting to open a new battlefront to stop newer technologies like nanobiotechnolgy and synthetic biology. In fact, it is not in their best interest to learn facts and truth about science and biotechnology. They are just waiting for their masters in Europe to give them a call. It would not be too long before they start their "Free India of Synthetic Biology and Nanobiotechnology" campaign. Right now, they are too busily entrenched in the anti-GMO warfare. They just want to keep the pot stirred by making loudest noise possible so that authorities start clamping down on them, and choke them to death. Pseudo solutions Slogans against nanobiotechnology and synthetic biology are still the same old worn out and clichÃ©d that they were against GMOs â€“ scientists do not know what they are doing; they have no idea about the long-term consequences of these technologies; these technologies will not help the poor, lots of imaginary ethical concerns, and worse private corporations will make usurious profits by hoisting new technology products on the unsuspecting public when we really do not need all these techno-fixes for problems in our society. They want all scientists and companies to become philanthropic, and share their knowledge and skills for the greater good of the humanity without returns. Sounds like socialistic Utopia. You got it right. Remember all these NGOs are fully paid members of the World Social Forum (WSF), the anti-thesis of World Economic Forum (WEF) and the World Trade Organization (WTO). The scientific community around the world was caught napping when the anti-GMO movement started. When some of us woke them up from the slumber, they simply waved their hands, and said "Oh! Do not worry. All this fussers will go away." However, the antis did not as we can see today. They are all well heeled, deeply entrenched, organized, and will fight to the bitter end. They are now a multi-million dollar, multi-national protest industry, no different from a multi-national corporation. The European Luddites have done everything possible to drive the biotech industry out of Europe whereas North America merrily went on to innovate and created a multi-billion dollar biotechnology industry creating job opportunities, economic growth, and become a world leader. The Indian Luddites drawing inspiration from their European brethren are doing everything possible to kill biotech development and take the country backwards to organic agriculture, systems rice intensification (SRI), and natural farming, whatever these mean to them. One of the Luddites in India said that Indian agriculture needs be "re-ruralized," meaning going back to pre-green revolution days. Why do anti-technology activists hate modern science and technology? Their motto is very simple. If it is made in the US, and if it is good for America, then it must be bad for us and bad for our poor people. Therefore, throw the baby along with the bath water. The Indian Luddites are so desperate that they are willing cut their nose to spite their face. For them, even an indigenously developed GM crop is no good. See, they have to come across as objective. Indian Luddites have not still caught on to nanotechnology and synthetic biology bandwagon, perhaps because they just do not know what these two new beasts are. Not that it has bothered them before just because they do not understand science. I hope this article does not give them ideas. Nevertheless, again the lack of any understanding of science and technology has not stopped them before. They must be waiting for a European sponsor to hand them the relay baton to start crying hoarse here. The scientific community should not lose the opportunity this time to take the lead and to educate politicians, policy makers about nanotechnology and synthetic biology to see that these new disciplines are brought to bear on India's development. There are some select centers in India doing excellent basic research in nanobiotechnolgy and synthetic biology, and they should be encouraged. At the same time, Indian academies of science must start producing white papers on these technologies to inform the public, government, and media about the risks and benefits of these new technologies, and create a favorable public opinion for the development of these newer technologies. Potential of newer technologies Synthetic biology is a pioneering field of new biology in which sub-cellular components and molecules can be assembled to create designer life forms for useful purposes. In one sense, synthetic biology is as old as synthetic chemistry. In fact, chemists who started understanding the structure and function of biomolecules started synthetic biology. Dr Hargobind Khorana got his Nobel Prize precisely for synthesizing polynucleotides (DNA) in a test tube, which paved the way for a flourishing nucleic acid synthesis industry. Scientists have been synthesizing or semi-synthesizing many macromolecules like proteins, carbohydrates and antibiotics for along, and these processes have helped enormously to bring down the costs of chemicals and drugs. Synthetic biology promises to do the same. Dr Craig Venter, a pioneer in this field recently appeared on several TV talk shows in the US and "Hard Talk" on BBC explaining synthetic biology and its potential uses. Smart TV talk show hosts grilled him with questions about environmental, public health impacts, and ethical concerns of synthetic biology and he gave convincing answers to lay those concerns to rest. His new book, "A life Decoded; My Genome; My Life" is a wonderful read for all interested in future of modern biology. Craig Venter is not just interested in understanding how life works, but he is trying to make it work for human beings. To a criticism that scientists are playing God, Dr Venter said a brilliant thing. He said he would like to excel God in playing God as the benevolent God we all know has made some horrible mistakes in creating life forms, and he would like to correct them. Asking hard-nosed questions about the safety, utility, risks, benefits, and being concerned about socio-economic impacts are all normal, and everyone should collaborate in such an exercise, and find appropriate grounds for benefiting from this technology. However, demanding total stoppage of the technological development is clearly out of place. The more sinister thing is to scare the public without any basic understanding of the technology just to kill technological development on some political agenda as if techno-imperialism is a crime against humanity. Science and technology waits for none. If India is held back because of anti-technology activism, it is only the Indians who are going to suffer, but not the urban Luddites who have carved out a nice life for them anyways. Nanobiotechnology and synthetic biology have so much of potential benefits to offer, and can solve many of the intransigent problems of our society. It is not unimaginable to synthesize organisms that can remove excess carbon dioxide from the atmosphere, clean up pollutants in soil and water much more efficiently than hitherto before. The biggest hope for synthetic biology is to design organisms for bioenergy production in a cost effective and efficient manner. These may sound like dreams, but remember GMO was also a dream not too long ago. Science and technology development should not be stopped because of political demagogues. Need for initiatives by scientists Nanotechnology is once again not a brand new science that has not been seen before. It is just a new fancy name for methods and processes that are carried out at sub-micron level. It goes further than that and can get very sophisticated. Application of nanotechnology can be endless. Nanotechnology combines physics, mathematics, chemistry, and biology to find applications in medicine and agriculture and environmental protection. Dr Anita Goel, a 34-year-old MIT scientist of Indian origin is making headlines in the US in the field of nanobiotechnolgy and it is wonderful to see such brilliant young minds achieve such laurels, and they can all be helpful to India's growth in modern technologies. She is already helping Himachal Pradesh to set up a biotech park in Solan. India needs to create and nurture such young minds in a creative atmosphere for the benefit of its people. May her tribe flourish. UK's Royal Society has taken the lead by releasing a report on nanotechnology in which it asked for a science based assessment, which is the right thing to do. Every stakeholder must take part in a comprehensive assessment, and then decide priorities for proper technological development. No one technology is a panacea for all our problems, but there is no doubt that all of them when used appropriately can benefit the society. If the scientific community in developing countries does not take this matter seriously, the Luddites will have a free reign again, and there is no telling where this will all end up. Whenever scientists have spoken in strong terms, the controversies have subsided quite fast. The best example of that in India was when a paper by Kranti et al in Current Science on differential expression of Bt gene in Bt cotton was erroneously bandied about as the best scientific evidence for alleged Bt cotton failures in the country. Mercifully, the scientist Kranti took effective steps by writing in The Hindu to put an end the scientific nonsense that the Luddites were propagating. It is another thing that Bt cotton is a hands down winner in India, and has overtaken China in GM cotton area. However, the shameless Luddites will concede an inch on this score. The Indian scientific community must develop a stake in India's science and technology development, and never let scientific ignoramuses, and wanton "mischief makers" with scientific credentials to hijack the science and technology agenda. India needs all the science and technology it can muster for its development and more, and not endless controversies, and debates by the Luddites. Scientists must take the initiative to reach out to the public through media and build confidence in science and technology. Even though, nanotechnology and synthetic biology are seemingly young and promising, they should not be allowed to become a victim of the Luddite shenanigans. India has so many scientific academies and scientific associations and societies. They all have to come out with a white paper on all emerging technologies, scientific pursuit, and advise the government, courts, and the media to place the proper facts before the public. Otherwise, who knows how many more cattle, sheep, donkeys, pigs, and chickens will die because of nanotechnology and synthetic biology? If only the Agricultural Sciences Academy of India or the Indian National Science Academy had filed a friend of the court brief against all the nonsensical court cases against GM crops, those cases could have been dismissed out of hand.   ]]> <![CDATA["We are looking at competency in molecular biology"]]> https://biospectrumindia.com/news/95/7521/we-are-looking-at-competency-in-molecular-biology.html https://biospectrumindia.com/news/95/7521/we-are-looking-at-competency-in-molecular-biology.html Thu, 13 Dec 2007 13:24:00 +0530 New Page 1 "We are looking at competency in molecular biology" -Dr Rama Mukerjee, founder, Ara Healthcare, Gurgaon Dr Rama Mukerjee has been the brain behind Dabur Research for quite a few years where she headed the R&D unit and came up with new and innovative products. She is now all set to synergize her scientific capabilities coupled with entrepreneurial spirit as she takes on the mantle of heading her own company, Ara Healthcare, an innovation driven organization that would focus on the commercialization of research. The company based in Gurgaon will soon be operational. Dr Mukerjee has got together a team of six scientists from Dabur and recruitment is on to ensure that Ara is 30-people strong by this year-end. They already have three molecules from Dabur (for cancer) for further development out of which two are NMEs and the third is a biological entity. The company will also focus on developing leads for autoimmune diseases, diabetes and obesity, infectious diseases and genetic disorders. In an exclusive interview with BioSpectrum, Dr Rama Mukerjee talks about her vision for the company and much more. Some excerpts: What was the vision behind coming up with a new company? The company has been in existence for the last four years. We did a couple of projects and I carried out a survey on Indian R&D and we realized that there isn't innovative R&D in India. That really stimulated me to get into innovative R&D. I thought we could be somewhere in the global map for developing significant number of novel products. I could not develop them alone, but I could develop some of them and that was the motivation. Also in the post genomic era, we are yet to utilize genomic applications in our drugs, therapy or diagnostic applications. Also, if you see all large molecules in the market, the blockbusters, somebody picked them up and built on them and then outlicensed them to large pharma. I found this very attractive, exciting and challenging. What will be the core competency of Ara Healthcare? We are looking at competency in molecular biology, i.e. developing NMEs (new molecular entities), recombinant proteins, humanized antibodies and the like. It will be partly drug discovery, but a lot on product development in terms of preclinical and phase I development of the product. We would like to take the leads from universities and research institutes at a very early stage, then do further discovery to find out at what stage is it, is it a hit or at a very early lead stage. Then we would optimize and look up and build the lead and then take it forward for preclinical and phase I. Optimization may also involve coming up with a better molecule. Basically we would like to see the early discovery with universities and research institutions where we will have very close tie-ups. How would you describe the business model of the company? There are three things that we are looking at. In order to generate revenue for the first few years, we will provide molecular diagnostic services like real time PCR, sequencing technology and chromosomal analysis. We hope to become a strong reference lab people would refer to where we can provide testing for infectious disease, cancer and genetic disorders. This would not only be our revenue earner for the first few years but would also provide us valuable information that we could utilize for our R&D program. About 25 percent of our activity would be on contract research. We would be willing to do protein formulation and protein product development as that would further add to our skill set and capability. Basically we want to develop the expertise around developing the product along preclinical and phase I and outlicense it. How different would Ara Healthcare be from other biotech companies? What would be its USP? One is the company's focus on NMEs i.e. biotherapeutics and humanized antibodies along with molecular diagnostics which is something unique to our company. Second, we are not a CRO. Majority of the companies in India are doing that. This is how we differentiate ourselves from other companies. We are looking at building our own products and so building our own value-added capabilities. If someone comes to us with an observation to get a product made on these lines, we would be ready to work on it. We would proactively go and get products from universities and research institutions, evaluate them, bring them and work. We hope that big pharma and financial institutions will come to take equity and support us. Shalini Gupta   ]]> <![CDATA[India gets a biotech policy finally]]> https://biospectrumindia.com/news/95/2329/india-gets-a-biotech-policy-finally.html https://biospectrumindia.com/news/95/2329/india-gets-a-biotech-policy-finally.html Thu, 13 Dec 2007 13:16:00 +0530 New Page 1 India gets a biotech policy finally After grappling with the unprecedented growth of biotechnology for over three decades, India has finally got a national policy on this segment in place. The National Biotechnology Policy, officially called the National Biotechnology Development Strategy, was unveiled by Union Minister for Science and Technology Kapil Sibal in November. Sibal and the DBT Secretary Dr MK Bhan deserve full kudos for piloting the comprehensive policy through the choppy waters of India's complex government policy-making process after extensive consultations with all the stakeholders. Even while the policy was awaiting the final approval from the Union Cabinet, DBT had implemented most of the important decisions and paved the way for the growth of the sector in recent years. Now these measures have got the official approval. Of course, the final policy has added a few more path-breaking initiatives to encourage public-private partnership, fund advanced technology research and build up human resources. One of the boldest initiatives is the commitment to spend 30 percent of DBT's annual funds on private-public projects. Few government ministries have made such a public commitment so far. The SBIRI scheme will encourage entrepreneurship and meet some of the demands for early stage funding to handle risky parts of biotech product developments. However, the much awaited single window clearance facility, which should have come through the proposed setting up of the National Biotechnology Regulatory Authority (NBRA), has yet to become a reality. It may see the light of the day only if Prime Minister Dr Manmohan Singh intervenes to settle the turf war between the ministries of health, agriculture, science and technology and environment over gaining administrative control of the proposed regulatory agency. Not many nations have succeeded in ensuring this, except Australia, which has an omnibus regulatory legislation and authority to handle all biotech related matters. Policy makers have more or less delivered on their promises made to the biotech industry in the last three years. It is now upto the industry to unleash the entrepreneurial spirit to take this forward, ignoring the few continuing procedural issues in dealing with government agencies. December is the time for the annual BioSpectrum Awards. The 5th edition of BioSpectrum Awards is another tribute to the pioneers of the biotech segment. Each and every awardee this year is a true representative of the pioneering spirit in this sector. The BioSpectrum Life Time Achievement Award goes to Dr PM Bhargava who has a long list of pioneering acts in the biotech sector. He visualized the beneficial effects of biotechnology, used this word for the first time in the country and also coined the term "genetic engineering" for the first time in the 1970s. He championed the growth of the biotech industry, set up India's best research lab, CCMB and developed the highly useful DNA fingerprinting technology. Dr Bhargava is a true scientist who speaks eloquently and fearlessly about issues that concern him. He richly deserves the honor. Varaprasad Reddy, the BioSpectrum Person of the year, is the industry pioneer who set up Shantha Biotechnics to develop the country's first recombinant product--Hepatitis B vaccine. He has followed it up with a cervical cancer vaccine in 2007. The Entrepreneur of the year, Dr Vijay Chandru, is one of the first leaders in this industry to successfully cross the bridge between academics and industry. His Strand Life Sciences is a model for all budding entrepreneurs. BIOMAb EGFR, the BioProduct of the year from Biocon, is a pioneering monoclonal antibody-based product. Various states have been trying to attract biotech investors and Gujarat, under Chief Minister Narendra Modi has been highly successful in the last two years in this area. No wonder the jury has chosen Gujarat as the BioState of the year 2007. The awards will be presented in Bangalore on December 21, 2007. See you all there. <sureshn@cybermedia.co.in> ]]> <![CDATA[Vibrant Gujarat]]> https://biospectrumindia.com/news/95/5234/vibrant-gujarat.html https://biospectrumindia.com/news/95/5234/vibrant-gujarat.html Thu, 13 Dec 2007 12:22:00 +0530 New Page 1 Vibrant Gujarat India's leading industrialized state, Gujarat, may be a late entrant to join the biotech bandwagon. But in the last two-three years it has transitioned to be an attractive destination for biotech investments. Driven by new enterprises and innovation in recent years, the biotech sector in Gujarat is witnessing accelerated growth in all directions. A strong base of various industries like the pharmaceutical, chemicals, and food and beverages sector provides the ideal ecosystem for Gujarat to succeed in the biotech arena. Gujarat's potential The biotech sector is Gujarat consists of 40 core biotech and 66 allied organizations. The biotechnology stakeholder profile of Gujarat consists of corporate (67 percent), academic institutes (20 percent), research institutes (11 percent) and NGOs (2 percent). There are two biotechnology clusters in the state-the Ahmedabad biotech cluster and Vadodara biotech cluster. These clusters have the potential to attract investments and provide employment opportunities as they have a good mix of all the stakeholders. In terms of type of biotech companies in the state, around 48 percent companies are involved in manufacturing activities, 34 percent in R&D activities and 18 percent in services. Interestingly 62 percent of the biotech companies are diversified units of established businesses like Torrent Gujarat Biotech (Torrent group), Indus Bio-therapeutics (Intas Pharmaceuticals), Synbiotics (Ambalal Sarabhai), and Bio-Arc solutions (Alembic Grop). Pure Play organizations account for 19 percent share of the total number of biotech companies--Maps Enzymes, Concord Biotech, Chiron Behrings and Span Diagnostics. Service organizations like Quintiles, Synchron, Clinisearch, Lambda therapeutics, RCC, and Simbec account for another 19 percent share. The industry has evolved around few sub-sectors like healthcare (60 percent), bioagri (20 percent), industrial biotech (6 percent), environmental biotech (6 percent), and others (8 percent), which include contract research services suppliers, foods and nutraceuticals and marine. Several companies figure in the list of top biotech companies and they cut across sectors. For example, Quintiles Spectral with revenues of over Rs 62.55 crore, Cadila Healthcare with revenues of Rs 55 crore and Span Diagnostics with revenues of over Rs 35.62 crore figure amongst the top biotechnology companies in the country. Maps (India) from Gujarat is also a leading bioindustrial company. Intas from Gujarat, has launched three recombinant products in last three years. Investments According to Akshay K Saxena, mission director, Gujarat State Biotechnology Mission (GSBTM), Department of Science & Technology, Government of Gujarat, while investments in the biotech sector in Gujarat in the last 10 years has been to the tune of Rs 300-350 crore, the annual turnover in biotechnology in Gujarat has been around Rs 500-600 crore. During 2003-07 alone, the investments were worth Rs 200 crore and was being done purely as expansion by existing players like Chiron Vaccines, RPG life sciences, Americoes, SPAN diagnostics, Concord, Cadilla Pharma, and Clinsearch. GSBTM is encouraging new entrepreneurs to diversify into biotech and is taking steps to attract investments into Gujarat from within the state, out the state and from global players. Aumgene Biotech, Augene Biotech, Enzymes Ltd, MaXEEma Biotech, CiPPY Bio International, Italia Biotech, Shalley Biotech, SUN Agri-genetics, and DIMA Diagnostics are some of the new start-up companies that has started operations in the state. Acton Biotech was incubated in NIRMA labs and has established its unit in Pune. The proposed investment has increased several folds during its "Vibrant Gujarat" industrial summit 2007, which was held early this year. The summit has seen investment initiatives of Rs 1,500 crore in biotechnology. These investments will be unleashed within the next three years. The summit also witnessed signing of 19 Memorandum of Understandings (MoUs) between the state biotech players and the industrialists from abroad and outside Gujarat. These projects will also provide with around 8,000 new employment opportunities. Some of the players who have expressed interest to invest in Gujarat during the Vibrant Gujarat include MJ Bio-pharma, Anhox, Oxygen Healthcare, Zytex, BDR Pharmaceuticals, MABS International, and Total Potential and land has been purchased by them. A commitment of approximately Rs 700 crore has been made by above companies, including the BT Park developer- Akruti Nirman. This apart the various existing units are investing in biotechnology by virtue of expansion of their facilities. These include Hester Pharma, Chiron Vaccine, Concord Biotech, Intas Biopharma, and various others who have committed nearly Rs 155 crore. Pharma giant like Zydus Cadilla have also entered the biotech sector in big way in Gujarat, with committed investment of around Rs 100 crore. Global companies like US-based Stemcyte Corporation is also starting its operation in Ahmedabad, with committed investment of Rs 100 crore. US-based Alexandria has also committed investment which is under due diligence by company. Hyderabad-based NUSUN has finalized its plans for Rs 40 crore investment in the state and has procured land near Ahmedabad. IKF Technologies is committing Rs 100 crore investment and is in advanced stage of land procurement. Vaishnavi Biotech, a subsidiary of Hyderabad-based Pratistha Group, has already procured land at Bhavnagar and is procuring equipment, as part of its Rs 90-95 crore investment in Gujarat for a bio-pesticide project. US-based AMNEAL Pharma is investing around Rs 50 crore for its preclinical facilities at Ahmedabad. The company plans to develop its own SEZ near Ahmedabad. Anil Product has made investment of nearly Rs 100 crore in its existing facilities. The Institute of Clinical research has started its operation from Ahmedabad. HIRAK Biotech is investing Rs 10 crore in developing an R&D center. Sterling Biotech also has made an investment of nearly Rs 150 crore in its recently acquired facility at Vadodara for gelatin production, and today has the largest production center in Asia. The company has started production of satins and therapeutics. Government initiatives The government has taken the approach of developing the biotech sector in Gujarat in a holistic way, by creating not only a conducive environment, but also a good support structure. As part of that strategy, the Gujarat State Biotechnology Mission (GSBTM), an autonomous body under the Department of Science and Technology, Government of Gujarat, is facilitating the growth of this industry. The governing body of GSBTM is headed by chief secretary of Gujarat and has representation of policy planners of various departments, industries and academia. Gujarat Biotech Venture Fund (GBVF) is an initiative of GSBTM to enhance the investment in the state's biotechnology sector. Managed by Gujarat Venture Funds Ltd, GBVF is a 12-year close-ended fund with an initial corpus of Rs 50 crore. The amount would be invested in the biotechnology companies of Gujarat. The state is developing a biotechnology park at Savli in Vadodara in three phases, in an area of 700 acres. The Park is being developed under public- private partnership. The park has two components--Innovation arcade and Industry arcade. While the industry arcade is to be developed by private developer and innovation arcade is being developed by the state government. The private partner has been selected and a portion of the park has also been given the SEZ status while the second portion of SEZ, planned by private partner is under scrutiny. The entire park is in advance stage of receiving environmental clearance, as per EPA, 2006. The state is also gearing up for an agro-biotech park. The government land for the park has been identified and the process for its reservation and the selection of the private partner is under the way. The process for developing a marine-biotech park in Gujarat has also been initiated. The government land for the park has been identified too. In addition to the land availability, the state government also proposes to facilitate development of other sector specific infrastructure such as centers of excellence, incubation, accreditation, testing, and validation in the respective zones.   "Gujarat plans to build a world class biotech cluster" - Narendra Modi, chief minister, Gujarat Excerpts from an interview with the CM taken in March 2007 You have coined the term BT+BT = BT (Bharat Today + Biotechnology =Bharat Tomorrow). Considering this, what could be the contribution of Gujarat one can expect in Bharat Tomorrow? Gujarat has been the one of biggest contributors to Bharat Tomorrow. The lead entrepreneurs in biotechnology from Gujarat, have been making their mark nationally and internationally. Gujarat has been amongst the first few to adopt the agro-biotechnology and emerge as a major cotton producer. In the coming times, the emphasis would be on producing life saving biotech drugs for which patents have already expired. Gujarat has a history of producing drugs at affordable prices and in consonance with this tradition Gujarat would take lead in this area. Gujarat, with its favorable geographic location, diverse climatic conditions, rich marine and microbial biodiversity, would like to make drugs and therapeutic products for the country and human society at affordable prices. Better yielding groundnut, value added products from castor, biotechnology based vaccine, both for human as well as animal healthcare, higher availability of dairy based products, trendsetting technologies and practices in medical and solid waste treatment, are few of the areas in which Gujarat expects to contribute to Bharat Tomorrow. What proactive role do you envisage for biotechnology to be an early gainer in the next decade? The state has taken definite pro-active actions on organizational, planning and implementation front. The Gujarat State Biotechnology Mission (GSBTM) takes care of the organizational part. Developments of long-term vision, biotechnology development strategy, sector specific strategic road maps, are crucial actions from the planning angle. Development of infrastructure, developing skilled human resources, supporting biotechnology research, encouraging biotech entrepreneurship and business are the main priorities from the implementation perspective. Sector specific BT Parks, agro-BT park, marine BT park, specific facilities like marine resources center, dedicated value addition training programs, both in universities and in collaboration with industries, focus on teachers' training, modern infrastructure for biotech research in universities, establishment of biotechnology venture fund, are few of the pro-active actions of the state government. In coming five years, the state government plans to allocate nearly Rs 200 crore to biotechnology. Gujarat being one of the leading pharmaceutical bases of the country is now losing investments to other north Indian states because of their offerings to the entrepreneurs. How do you wish to address this issue? The key parameters for industrial development and industrial investments are urban, social and industrial infrastructure. Gujarat has been providing it since long and that is why it has been in forefront of industrial development. However, the entire country and all its states offer options and choice. Gujarat, while welcoming the pro-active role of different states, stands committed to provide the facilities, which are key for sustained operations and business in the long term. Gujarat with its industrial infrastructure, power availability, labor and employment, investor-friendly business environment, would continue to attract industries. Better infrastructure base, assured power supply, social infrastructure would continue to be the state's offering for future and prospective BT investors. And in this respect, the state's government vision of developing a mega city is one such initiative to attract investors from different parts of the world. How does the government intend to promote research-based biotech initiatives in the state? The state is already providing funding support to biotech research. The state has developed a dedicated action plan for promoting biotech research. It has identified sector-specific facilities, and institution-specific facilities, which would be developed alone or through collaborative funding. The state plans to make universities and educational institutes into a hub of biotech research, develop modern biotech research and incubation facilities in different universities, encourage researchers and faculties to undertake collaborative projects. Active research by existing teaching faculty is one of the priorities. The state plans to take stock of the present research scenario and would work out the priorities. N Suresh   ]]> <![CDATA["We are setting up a flow cytometer center of excellence in India"]]> https://biospectrumindia.com/news/95/8134/we-are-setting-up-a-flow-cytometer-center-of-excellence-in-india.html https://biospectrumindia.com/news/95/8134/we-are-setting-up-a-flow-cytometer-center-of-excellence-in-india.html Tue, 06 Nov 2007 14:32:00 +0530 New Page 1 "We are setting up a flow cytometer center of excellence in India" -Sunit Trivedi, general manager, Biosciences, BD India BD India has principally been manufacturing a broad range of medical supplies, devices and diagnostics products and is also looking at strengthening its biosciences segment along with foraying into yet other new areas. BioSpectrum met Sunit Trivedi, General Manager, Biosciences, BD India, to find out the company's future areas of focus as it moves ahead. Excerpts from an interview: What have been the revenue grossing products under the different business segments of BD India? The medical business is a topline generator for us. There are devices, injections, needles and thus it is a big market. Under this, Venflon is one product that can be termed as a flagship brand. Also prefilled syringes are another potential segment looking at how pharma companies are looking at marketing their products. Diagnostics is growing at 15-20 percent. Under this segment, we have a product called vacutaner, which is for blood collection that has been extensively used by us for HIV-AIDS monitoring. In India only 3 percent of it happens through vacutaners as compared to 99.9 percent in the US. So it is a huge market for us to tap. Bactec, a product for blood and TB culture and to find out septicaemia is another on the list. Biosciences-Flow Cytometer (FACS), FALCON (labware product used in in vitro fertility clinics), PHARMIGEN (most used cell biology antibody on flowcytometer or no flow cytometer based assays)-is another key segment for us. What have been the new products introduced this year? Gentest is one of our new introductions. It is a product range focused on solubility and toxicology testing of drugs and is targeted mainly at pharma companies. Although it has been with BD for the last two years, it is only recently that it has been taken up by BD India. The product reduces the life cycle in terms of introducing a new drug. Once they come up with the drug they need to conduct these tests. Again a few pharma companies are using this product but we are looking at growing the customer base. We are also looking at CROs who have been operating in western countries and want to outsource this kind of testing in India. These are high value systems in the range of Rs 1-2 crore and we are in talks with few pharma companies and CSIR institutes. We expect some business this year itself.   FACSARIA is a high end sorter in the range of Rs 1.5-2 crore per system. This year we have been able to sell 11 systems to research institutions.   FACS CANTO II is a product for cancer diagnosis. It offers six color differentiation which leads to better lymphoma and leukemia diagnosis and monitoring. We are trying to set this trend in India. We have also conducted training programs for the same. We have sold six systems in the first year.   Any new products to be introduced next year? We are into public-private partnership with Clinton Foundation and NACO for HIV AIDS under which BD helps in CD4 monitoring. To help this, we are going to introduce a product by January next year that will help predict the percentage of CD4 that is required to monitor pediatric range. It is to be used on a system called FACS count (that cannot do percentage) that can be upgraded and can help NACO sites to do percentage.   What would be the focus areas for BD India in the next few years? Bionutrients business: A lot of companies are making forays into the vaccines business and they are not only Indian companies like Serum and Shantha Biotec, but also international companies which are setting up shop here. We have a certain product range called Bionutrients which has a very long gestation period since one has to get the right kind of FDA approval. This is something that has been on the backburner but we are going to take it up on a very massive scale for vaccine manufacturers such as Biocon. Although these are early days, we foresee that they could be big growth drivers for us in the future. Stem cell research: A lot of basic and clinical research is happening in this area. However, stem cell therapy, the way it is done in India is subject to a question mark. The stem cells injected into the patients have to be highly pure. What is currently available is three percent purity, but what is required is above 95 percent purity. BD sees this as a research opportunity. We have high end flow cytometers, so we can sort these cells and then put it for clinical use. But we will be promoting it as a research tool, not as a clinical tool. And the basic customers as we see would be DBT, ICMR and CSIR institutes.   Cord blood banking: We have some tools in the range of flow cytometers through which we think we can address this market in the future. It is an emerging market, though nascent right now with two or three set-ups.   Live cell imaging: BD recently acquired US-based Atto biosciences and with this we think we are better equipped to address the growing market of high-content high speed live imaging. Through this we can address the needs of pharma companies and academic institutions doing cell biology based research, wherein they can scan hundreds of live images in a few minutes thus reducing time. Are you looking at any investments in training? We are setting up a Center of Excellence in India for flow cytometer along with an institute by the end of this year. BD will do the entire training for customers for high end flow cytometers. We also conduct training within the organization in our training center. We sell, but it is our responsibility to educate the customers and this is one reason why we feel customers buy from us. This initiative will only take that vision a step further. Shalini Gupta   ]]> <![CDATA[Valve innovations assist biopharmaceutical processes to achieve cost reduction and cGMP]]> https://biospectrumindia.com/news/95/7855/valve-innovations-assist-biopharmaceutical-processes-to-achieve-cost-reduction-and-cgmp.html https://biospectrumindia.com/news/95/7855/valve-innovations-assist-biopharmaceutical-processes-to-achieve-cost-reduction-and-cgmp.html Tue, 06 Nov 2007 14:31:00 +0530 New Page 1 Valve innovations assist biopharmaceutical processes to achieve cost reduction and cGMP The biopharmaceutical industry is under constant pressure to increase quality, efficiency and speed time to the market while reducing production costs. To meet these heavy demands, companies are increasingly using new technologies while adapting and innovating faster than ever. Bioprocessing is widely believed to be the future of drug discovery and manufacturing. One of the most critical factors in the production of drugs today is the ability to clean and validate the drug production process. At the risk of oversimplification, cGMPs require that processing equipment be designed to be drainable, cleanable and sterilizable to minimize the potential for contamination, and therefore help assure the purity of the end drug product. Hygienic valves, particularly diaphragm valves, have become the most important control element of process piping systems utilized in the Bioprocessing industry today. The weir style diaphragm valve has become the standard due to the unique ability to provide a drainable valve with minimized product entrapment areas. As can be seen in Figure 1, the unique internal geometry of a diaphragm valve creates a flow path that minimizes hold-up volumes and optimizes process piping drain-ability. Utilizing the unique characteristics of the weir style diaphragm valve, valve manufacturers have helped develop many process fabrications to reduce product contact surfaces, reduce hold-up volumes, and minimize piping dead-legs. The theory is that as contact surfaces are minimized and hold-up volume is reduced in a process piping system, product yields and product purity will improve. In the not so distant past, typical process fabrications were produced by welding standard forged valve bodies in configurations designed specifically for certain applications and orientations. Figure 2 shows a process fabrication known as a Sterile Access port. Sterile Access fabrications are utilized for product sampling and/or a condensate drain. This fabrication has served the industry well, but has limitations. In some instances, where the main horizontal valve is large relative to the sample valve, the dead-leg between the two valves can fall outside FDA expectations. Figure 4 shows an old technology fabricated zero static use point. This technology has been replaced by integral block technologies in Figure 5. The FDA Guide to Inspections of High Purity Water Systems has defined dead-legs as "not having an unused portion greater in length than six diameters of the unused pipe, measured from the axis of the pipe in use. It should be pointed out that this was developed for hot (75-80º C) circulating systems. With colder systems (68-75º C) any drop or unused portion of any length of piping should be eliminated if possible, or have special sanitizing procedures." In cases where process piping falls outside of FDA expectations, as noted from the Guide to Inspections of High Purity Water Systems reference above, the owner of the system is expected to have special sanitizing procedures. These special sanitizing procedures can be expensive in terms of production time and processing cost and should be avoided whenever possible. As mentioned previously, the Bioprocessing industry has a critical need for a system that can be cleaned and sterilized and is able to minimize product contact surfaces and hold-up volumes. Until relatively recently however, there has not been a true guidance document to assist the Bioprocessing industry to achieve these higher levels of performance. Realizing the need for guidance the American Society of Mechanical Engineers (ASME) in 1987 began assembling a committee devoted to the development of a standard for the Bioprocessing industry. Almost ten years later a standard was released called the "ASME Bioprocessing Equipment Standard" (ASME BPE). This standard takes the issues of dead-legs in process piping to an even higher level. The BPE has created a new definition for the allowable dead-leg within a Bioprocessing piping system. The ASME BPE 2005 states "for high-purity water and clean steam systems, an L/D ratio of 2:1 is attainable with today's manufacturing and design technology... In many cases the old technology of welding standard valves into process fabrications will no longer meet this higher requirement described by the ASME. Also, per the definition of the cGMPs regulations, drug manufacturers are required to keep up with the latest trends in standards and technology. This is where the trend to migrate to integrally machined block valve bodies has begun. Integral Block Body & 3D CAD Modeling For many years hygienic diaphragm valve manufacturers have utilized CNC machining to create the complex weir geometry in forged valve bodies. It was not until the introduction of 3D parametric CAD systems that truly innovative process valve designs could be realized. Now with the common use of these 3D modeling programs, valve manufacturers are capable of creating an amazing array of valve designs to not only meet, but exceed the expectations of the Bioprocessing industry. Figure 3 illustrates this point. While Figure 3 serves the same functionality as Figure 2 instead of two separate valves welded together, both valves are machined from a integral block of 316L Stainless Steel. Not only does this greatly reduce hold-up volume and the length of dead-leg, it eliminates a manual weld. The presented example is a simple combination of valve and 3D CAD technology. An endless array of process configurations, to satisfy almost any application need can now be designed and manufactured. With only modest effort, Figure 6 and 7 illustrate a variety of multi-port divert valves. These valves can be combined in many ways to simplify and condense intermediate drug manufacturing processes. An excellent example is the use of numerous multi-port divert valves in a chromatography skid (Figure 8). A patented valve especial designed for chromatography columns has helped the industry optimize the chromatography process (Figure 9). There is endless potential for valve manufacturers and process piping designers to work together to provide innovative and cost effective valve and process system designs. Innovative designs can drastically reduce dead-leg, minimize hold-up volume, minimize product contact surface areas, improve drain ability, and contribute to product recovery from process piping and systems. All these factors help the Pharmaceutical and Bioprocessing industries improve their product purity and yield, while reducing overall costs. Paul McClune, ITT Corporation, USA   ]]> <![CDATA[Interviews of 2007 Shanti Swarup Bhatnagar Prizes winners]]> https://biospectrumindia.com/news/95/2171/interviews-of-2007-shanti-swarup-bhatnagar-prizes-winners.html https://biospectrumindia.com/news/95/2171/interviews-of-2007-shanti-swarup-bhatnagar-prizes-winners.html Tue, 06 Nov 2007 13:39:00 +0530 New Page 1 Interviews of 2007 Shanti Swarup Bhatnagar Prizes winners Eleven scientists have been selected for 2007 Shanti Swarup Bhatnagar Prize for science and technology. The Shanti Swarup Bhatnagar (SSB) Prizes are awarded annually by the Council of Scientific & Industrial Research (CSIR) for notable and outstanding research, applied or fundamental, in biological, chemical, earth, atmosphere, ocean and planetary, engineering, mathematical, medical and physical sciences. The purpose of the prize is to recognize outstanding Indian work in science and technology. Any citizen of India engaged in research in any field of science and technology up to the age of 45 years is eligible for the Prize. The Prize is awarded on the basis of contributions made through work done primarily in India during the five years preceding the year of the Prize. The SSB Prize comprising a citation, a plaque and a cash award of Rs 200,000. BioSpectrum caught up with three prize winners in the following categories: Medical Sciences: Dr Pundi Narasimhan Rangarajan, Indian Institute of Science, Bangalore Biological Sciences: Dr Upinder Singh Bhalla , National Centre for Biological Sciences, Bangalore and Dr Narayanaswamy Srinivasan , Indian Institute of Science, Bangalore Excerpts of the interviews in the ensuing pages:   Eukaryotic gene expression researcher Dr Pundi Narasimhan Rangarajan, IISc, Bangalore What has been the focus area of your research? The main focus of my research has been eukaryotic gene expression and infectious diseases. I was the first to initiate research on DNA vaccines in India as well as virogenomics and my research has spanned the development of DNA vaccines against Japanese encephalitis virus (JEV) and rabies virus as well as study of host gene expression during virus infection. My research on virus-inducible gene expression changes in mouse brain has led to identification of several novel genes. These include: A novel Virus Inducible Non Coding RNA (VINC) which was recently shown to be associated with SC35 nuclear speckles (Hutchinson et al., BMC Genomics 2007, 8: 39); GARG39/IFIT2, a novel microtubule-associated protein enriched in the mitotic spindle of actively dividing normal and cancer cells. The JEV-repressible murine Ca2+/calmodulin kinase II inhibitor (CaMKIIN) which was localized for the first time in the post synaptic density (PSD) of mouse brain. I developed a novel strategy of enhancing the potency of rabies DNA vaccine which was granted patents in Europe, South Africa, India, Canada and China. The preclinical toxicity studies of this novel combination rabies DNA vaccine has been completed and the vaccine is likely to be introduced in the market as DINARAB by Indian Immunologicals Ltd (IIL), Hyderabad after obtaining regulatory approvals. What are your current research areas? I am currently heading a new research program on the study of biology of non-conventional yeasts at IISc, funded by the Department of Biotechnology. Realizing the importance of microbial expression systems in biotechnology and the lack of knowledge on basic mechanisms of gene regulation, I had initiated a new research program on the biology of Pichia pastoris, a methylotrophic yeast widely used for recombinant protein expression. Such studies have led to several interesting findings including the isolation of yeast homologue of vertebrate lens-specific zeta crystallin (ZTA1) and its identification as a single stranded DNA binding protein. Using the Pichia recombinant protein expression system, we developed recombinant yeast strains expressing high levels of Hepatitis B surface antigen. These strains were transferred to two companies in Hyderabad, one of which (Biological E) produced the recombinant hepatitis B vaccine and launched it as BEVAC on December 22, 2004 while the other company (Indian Immunologicals Ltd) launched it as ELOVAC-B on September 26, 2006. What have been your contributions to collaborative research? My ongoing collaboration with Prof. G Padmanabhan at IISc on malaria has led to the identification of a novel heme biosynthetic pathway in the malarial parasite as well as discovery of antimalarial activity of curcumin, a component of widely used Indian spice turmeric. Based on this research, human clinical trials of artemisinin-curcumin combination therapy for malaria have been initiated recently.   Computational biology expert Prof. N Srinivasan, Molecular Biophysics Unit, IISc, Bangalore What has been the focus area of your research? I would like to mention that the award this time is also a special recognition for computational biology which is emerging as an important branch of modern biology. My area of research interest is evolution of structure, function and interactions of proteins. We develop and use computational biology approaches to address fundamental questions in this area. World-wide genome sequencing projects of human, model organisms and pathogens results in the availability of amino acid sequences of all the proteins encoded in the organisms. However, information on functions and biological roles of many of these proteins is yet unknown. Unless we have a reasonable understanding of the functions of these proteins, we cannot hope to use the genome information in an effective way. For example, understanding of functions of proteins encoded in the genome of a pathogen contributes profoundly in the understanding of associated disease process and hence in the design of inhibitors which may emerge as drugs. We employ computational tools, developed by us as well as by others, in recognizing functions and other properties of proteins encoded in genomes of hundreds of organisms. We recognized functions of many proteins in various organisms; particularly those involved in cellular signal transduction. Often we provided three-dimensional viewpoint of proteins using computational approaches that enabled appreciation of molecular basis of protein function. Our analysis of interaction between proteins provided new insights influencing our understanding of choice of protein-protein partnerships.   Computational neuroscientist Prof. Upinder Bhalla, NCBS, Bangalore What is the area of research that you are specifically focused upon? The major focus of my research has been computational neuroscience of memory and olfaction. My scientific contributions, as I see it, are in the analysis of information flow and memory storage at the synapse, which is a structure that communicates between nerve cells and secondly studying information processing in the sense of smell. In two major papers early in my career we showed how such information processing could occur, first through simulations (Bhalla and Iyengar Science 1999), then through combined experiments and models (Bhalla, Ram and Iyengar, Science 2002). At the macro level we use parallel electrical recordings to study detection and signal encoding (receptors, olfactory bulb) right through to the storage of olfactory memories (piriform cortex, hippocampus). We train animals on odor memory tasks to put these recordings into a functional context. At the micro level, we use microscopy and detailed computer simulations to explore the networks of signaling chemicals that operate in olfactory neurons. A key finding of our work is that inside cells, beyond the slow 'calculations" of DNA, the signaling system itself has sufficient complexity to operate as an independent, rapid computing system that can process and store olfactory information. We have also experimentally identified molecular circuits capable of another fundamental type of neural computation, time measurement. Having also demonstrated several time-related behaviors of the olfactory system as a whole, we are now well-positioned to compare the functional contributions of what are possibly the two most complex systems known-the circuitry of the brain, and its microcosmic equivalent, the circuitry of the cell. What are your other achievements? Our group has developed a database of signaling network models, doqcs.ncbs.res.in, which was one of the first such resources. We have also been developing simulation software for biochemical and neuronal modeling for many years. This was earlier part of the GENESIS project and is now a new initiative called MOOSE (http://moose.ncbs.res.in)   ]]> <![CDATA[From lab to boardroom]]> https://biospectrumindia.com/news/95/7877/from-lab-to-boardroom.html https://biospectrumindia.com/news/95/7877/from-lab-to-boardroom.html Tue, 06 Nov 2007 13:38:00 +0530 New Page 1 From lab to boardroom There has for long been a gap between research being done in our laboratories and its translation into innovative techniques and products that could be commercialized for the greater good of mankind. It is this gap that the biotechnology Young Entrepreneurs Scheme (YES) aims to fulfil and give wings to the ideas of young scientists. BioSpectrum spoke to the aspiring entrepreneurs. Excerpts: YES competition The Biotechnology Young Entrepreneurs Scheme (YES) is a UK-based competition opened for the first time for Indian students this year. It is an innovative academic business plan competition that raises awareness of the commercialization of ideas from young bioscientists. It was launched jointly by the British High Commission, UK Trade and Investment, University of Nottingham Institute for Enterprise and Innovation (UNIEI), Biotechnology and Biological Sciences Research Council, UK and the Ministry for Science and Technology and Ocean Development, India. Inaugurating the session, British Council Director, Rod Pryde said, "The UK's future is increasingly staked on successful innovation, and on building ever-stronger links between innovative research and the marketplace. We are delighted to offer young Indian entrepreneurs this opportunity to engage with their UK counterparts." Fourteen teams presented their ideas to an eminent panel comprising senior academicians, venture capitalists (VCs), experts from the Department of Biotechnology (DBT) and an industry representative. Of the 14, four teams were shortlisted to attend a three-day workshop in the UK, the last leg of which will be in December in London. During the workshop, the teams will attend sessions by leading British biotechnology experts on all aspects of commercialization of bioscience ideas. A novel treatment for diabetes Indian Institute of Technology (IIT) Bombay, School of Biosciences and Bioengineering Team members (pursuing PhD in Biomedical engineering): Ayesha Chaudhary (team leader) Swati M Deepti Dyondi Anubhav Kaviratna Rahul Dev Jayant What is your business plan? Ours is a therapeutic business plan for the treatment of diabetes using a combination of biotechnology and nanotechnology. Our product would be a replacement to the administration of daily insulin injections, which is quite a tedious job for the patients. It is a closed loop system, which provides a stimulus controlled long lasting delivery of insulin to the patients and would be better than the insulin pumps that need to be manually adjusted every time before use. Why did you choose this particular subject? Diabetes is a global health issue which needs to be tackled at the earliest. It is estimated that there would be 380 million diabetics by 2025 worldwide (www.biomarketgroup.com) and 79.4 million diabetics in India by 2030 (WHO). All this, gave us the thought of working towards diabetes therapy. An interaction with a diabetic patient was also a driving force. How feasible is your plan? What is the USP of your plan? We have developed a sterile, painless, long lasting and in vivo stimulus controlled insulin injection. The system works on the basic principles of nanotechnology and biotechnology. The USP of our plan is the long term release of insulin, and decreased risk of hypoglycemia. In addition to this, the product is also biocompatible and a cost-effective treatment. All the team members have hands-on experience on the various techniques and skills required for the product development and hence we are confident of the technical feasibility of the plan. In fact 25 percent of the average family income of an Indian goes into diabetes treatment. Thus, our product would be designed to be highly economical and easily affordable to the common man. In addition it would also be patient compliant. What is your view on the state of R&D in India as compared to other countries? And what do you think is needed to improve the current state? India is doing well in R&D especially in areas of healthcare. The research activities is commendable in few Indian universities, premier research institutions like IITs and some pharmaceutical companies compared to other countries. However, there can be a rapid improvement in R&D if the collaboration between the industry and the academia increases. There should be more scholarships from industries, application oriented-research and hands-on experience on industry problems. Indo-UK Biotechnology YES 2007 has been an excellent opportunity for us as it gave us an opportunity to think beyond what is to be explored. Innovative monoclonal antibody production Institute of Microbial Technology (IMTECH), Chandigarh Team members: Kamlesh Kumar Bisht Amin-ul Mannan Ashu Shah Sneh Lata Lomary Singh What is your business plan? Monoclonal antibody production: using a novel B-cell immortalization technique Why did you choose this particular subject? Monoclonal antibodies (MAbs) are real "magic bullets" used for the purpose of research, diagnostics and therapy. The worldwide market for therapeutic and diagnostic MAbs was $5.4 billion in 2002 and is expected to reach $26 billion by 2010. The development of hybridoma technology has opened the doors to the reproducible and large scale production of MAbs and this development was considered so significant, that it fetched Kohler and Milstein their Nobel Prize in 1986. But human monoclonal antibody technology has generally been hampered by various obstacles like lack of a suitable immune B cell source, poor direct B lymphocyte immortalization techniques and lack of suitable fusion partners. Several of these problems have been approached by designing humanized or transgenic antibodies, phage display technology and eukaryotic antibody expression system. Still, the preferred technique is the direct immortalization of individual human B cells, which is mainly achieved by Epstein-Barr virus (EBV) transformation. However, this approach has several drawbacks like the EBV-specific cytotoxic lymphocytes may attack and kill freshly EBV-transformed B cells in cultures; moreover, the EBV transformed B-cells are genetically unstable and are low antibody secretors as well. How feasible is your plan? What is the USP of your plan? We are proposing a novel idea in which the need of myeloma counterpart or EBV transformation will be completely eliminated for human MAbs production. We are suggesting a unique way through which a B-cell can be immortalized by exploiting its own genetic information. This will be achieved simply by converting the B-cell's own proto-oncogene into an oncogenic form, just by introducing a novel DNA construct into the cell using an easy lipofection protocol. The successful integration and expression of the designed construct inside the cell will lead to malignant transformation of the B cell. This fact makes it particularly useful to combine this immortalization approach with in vitro immunization schedules. Moreover, this approach will provide a monoclonal antibody that is entirely of human origin and is free of any heterologous sequences unlike the humanized antibodies. So far, on the basis of available literature we are strongly claiming that no such attempt has been made in this field till date. Advantages of proposed idea: Totally human antibody, free of any undesired immunogenic sequences. EBV transformation is not needed therefore, special safety laboratories not required. No need of human fusion partners (myelomas) which are rarely available. Economical, time saving and safe technique. What is your view on the state of R&D in India as compared to other countries? And what do you think is needed to improve the current state? Students in foreign countries are privileged with more liberty in research field. They can talk to their mentors in a very informal way regarding their ideas and research activities. Abroad, one can get a PhD degree only in three years while in India sometimes it takes more than five years. This kills all the enthusiasm to carry on research further. We need to have an examination system by which one can go into higher scientific positions without going through the hierarchical system of PhD, PDF, scientist and so on. In this way talented students can carry their research in more independent way. The future of vaccine delivery Institute of Chemical Technology (Formerly UDCT), Matunga, Mumbai Team members: Pirthi Pal Singh PS (team leader) Ratnesh Jain Prajakta P Dandekar Aditya Pattani Abhijit Date What is your business plan? Our business plan is based on the development of nanotechnology oriented oral vaccine delivery platform Why did you choose this particular subject or topic on which to base it? Most of the current vaccine products are injectable formulations which require skilled medical personnel for administration and result in a painful delivery. Furthermore, most of the vaccines contain ALUM as an adjuvant which by itself has long-term untoward toxic effects. These drawbacks and poor patient acceptability and reachability of injectable vaccine products have been a motivation for the development of oral vaccine platform. Also the colossal and renewing vaccine market has been one of the motivating factors for developing an oral vaccine product. How feasible is your plan? What is the USP of your plan? The market need for vaccine products is immense. About 25 million babies need to be vaccinated every year only in India. The unique selling features of the product include providing an oral vaccine delivery system at an affordable price. What is your view on the state of R&D in India as compared to other countries? And what do you think is needed to improve the current state? The R&D scenario in India has shown a continuous development and growth due to the various incentives and programs initiated by the government. There is still a need for entrepreneurship workshops and programs to give an insight to students with technical background. In this regard, the Biotechnology YES program comes as an excellent platform established by the UK government, which has now been made open to the Indian students through collaboration with the DBT. More efforts in this direction will definitely bring out more young entrepreneurs from amongst Indian students. ]]> <![CDATA[Ecology for success in the biomedical sector]]> https://biospectrumindia.com/news/95/1321/ecology-for-success-in-the-biomedical-sector.html https://biospectrumindia.com/news/95/1321/ecology-for-success-in-the-biomedical-sector.html Tue, 06 Nov 2007 13:19:00 +0530 New Page 1 Ecology for success in the biomedical sector Dr T Edison Liu Executive director of the Genome Institute of Singapore, Dr Edison T Liu, is a physician-scientist who trained with Nobel Laureate, J Michael Bishop. Dr Liu has authored over 220 papers, reviews and book chapters. He sits on a number of scientific boards for biotechnology and pharmaceutical entities and is also the executive director for the Singapore Cancer Syndicate - a funding agency, the Singapore Tissue Network - the national tissue repository, and is chairman of the Health Sciences Authority of Singapore, the country's FDA equivalent. The recent spectacular growth in biomedicine in Asia, from biotechnology and drug manufacturing to medical tourism, is a consequence of powerful social and economic forces driving global development. Many countries are seeking a cut of the action by setting up bioscience parks. Consultants are called in to advise governments on how they can establish a biotechnology industry. Some of this advice, however, is from a narrow business point-of-view focused on physical infrastructure and investment capital. In reality the development of a biomedical sector requires a broader developmental framework than any other industry, one that is more rooted in the local societal fabric than others and one that requires a unique participation of governments and a favorable legal system. Whereas a high tech chip manufacturing plant can be imported design and all, and the local workers trained in production, the establishment of a good hospital system requires excellent medical schools, advanced medical informatics, a blood banking system that is reliable and safe, and skilled ancillary personnel such as nurses and medical technologists educated in established vocational schools. Certainly, there are examples of high quality hospitals catering to medical tourists as the Apollo group in India and Bumrungrat in Bangkok, but these are occurring in countries with established talent pools that have been previously exported to western countries. It is this returning talent pool that is driving the quality of the systems. In biotechnology, biomedical research, and pharmaceutical development, the availability of a talent pool that embraces quality control, a professional culture that is steeped in competitive biomedical research, and an ethically-based legal system that not only cares for intellectual property but issues such as patient rights are essential for sustainable development in these sectors. So, cheap land and cheap labor that can attract inward investment for car manufacturing will not be the primary drivers for the success of a biomedical industry. The local and national social ecology becomes a decisive factor. Critics will point to the rise of advanced Indian pharmaceuticals and Thai medical services and the current plans to develop medical services in Dubai and UAE as exceptions. Indeed, these successes are spectacular but are primarily driven by simpler chemical processes (generics) or established to support a paying medical tourism market, which we believe, is a limited pool of patients. Both models are not sustainable in the long run without advancing into higher and more integrated forms. So what is needed? Here is where governments must be a major player. School systems should be structured to support the needs of this industry, which includes not only the training of research PhDs and MDs but also nurses and technicians. This requires the development and continuous upgrading of research-enabled universities that are adequately funded to conduct competitive research. Moreover, this funding must be based on competitive quality of work and not as a right of seniority. When talent cannot be sourced internally, then they must be attracted from the outside. Indeed, this is true for the US where a third of all biomedically-oriented PhD workers are foreign born. In addition, much of the success of China and India can be attributed to the repatriation of nationals who have succeeded elsewhere. Unlike manufacturing, where managerial talent can be imported, the importation of medical personnel often must deal with the protectionist practices of local medical societies. Therefore, the intervention of governments to open the medical markets and to allow immigration of foreign workers is essential to launch a biomedical industry. Finally, the most important factor is to root these developments to internal demand. Thus, biotech and pharmaceutical entities will need to show that their products benefit the local markets, and the advanced medical systems catering to foreign tourists must be made available to local citizens. A purely export mindset, which may work for textiles, will backfire in biomedicine because human lives and human dignity are at stake. This will ultimately require governments to spend more money in health care. The good thing, though, is that everyone will benefit from the virtuous cycles that follow.   ]]> <![CDATA[How to assure safety of GM foods?]]> https://biospectrumindia.com/news/95/2823/how-to-assure-safety-of-gm-foods.html https://biospectrumindia.com/news/95/2823/how-to-assure-safety-of-gm-foods.html Tue, 06 Nov 2007 13:15:00 +0530 New Page 1 How to assure safety of GM foods? India has two statutes that should be sufficient to bring GM foods under their ambit, but it needs scientifically sound regulations to test for GM food safety Dr Shanthu Shantharam, President, Biologistics International, Maryland, USA, (sshantharam@biologistics.us) Bt brinjal, Bt cabbage, Bt rice, and a series of GM food crops are making their way to Indian markets via a tortuous regulatory route. If everything goes well, Indians will be eating them safely in a couple of years. But, given all the brouhaha about their safety, the simple question is, are GM foods safe for consumers in the long run? It is an important question indeed, and one that must be asked by anyone with common sense. There are many answers. First, GM crops and foods are the most rigorously tested of all foods in the market, and second, the GM foods are being consumed in North America by over 350 million people since 1996 without a single verifiable ill effect on people or animals. The answer is "the proof of the pudding is in the eating!" Eventually, some people in India will have to eat and live to tell whether it is safe or not, but only if the government will allow. But, allow on what basis? Does the Government of India have a food safety policy and is that adequate to assure the safety of GM food? The answer is "yes" to both. India has two statutes -The Prevention of Food Adulteration Act of 1954, and The Food Safety and Standards Act of 2006 - that should be sufficient to bring GM foods under their ambit. There is really no need for another law. What India needs is scientifically sound regulations to test GM food for safety. The Indian Council of Medical Research (ICMR) has come out with a draft code of regulations to test for GM food safety in 2006 that is being debated in different forums. The draft codes of regulations contain the best elements of North American and European Union based on the non-voluntary Codex Alimentarius guidelines that are under development. The ICMR GM food safety guidelines adopt the principles of "substantial equivalence" and "precautionary principle" to make sure certain universal standardized tests for allergenicity, toxicity, chemical and nutritional composition is carried out. The purveyors of Bt brinjal have submitted the food safety data as required by the ICMR guidelines and have been reviewed by a group of competent experts appointed by GEAC, and have come to the conclusion that Bt brinjal shows no significant differences from a non-Bt brinjal. Some of the tests that have been conducted on Bt brinjal include toxicological studies by an accredited private lab in Pune, INTOX Pvt Ltd, using Sprague Dawley rats; allergenicity studies conducted by Bangalore-based Rallis India Ltd, by acute cutaneous anaphylaxis in Brown Norway rats; primary skin irritation test in rabbits at INTOX, Pune; and mucous membrane irritation test in female rabbit at the same INTOX labs. Major alkaloid content comparisons were carried out at the Indian Institute of Chemical Technology, Hyderabad that showed no differences between the GM and non-GM brinjal. Similarly, nutritional analyses on Bt and non-Bt brinjal were carried out to demonstrate that both are substantially equivalent in terms of major nutrients and minerals. In addition, wholesomeness of the feed from Bt brinjal has been demonstrated using fish, chicken, cow, goat and rabbit feeding studies. The rabbit study was conducted by Bangalore-based Advinus Therapeutics, the fish studies were done at the Central Fisheries and Education, Mumbai, chicken feeding studies at the Central Avian Research Institute, Izatnagar, goat feeding and cow feeding studies were carried out by Advinus, and GB Pant University of Agricultural Sciences, respectively. Clearly, by all universal standards, the GEAC has made sure that Bt brinjal is at least as safe and as nutritious as its non-Bt counterpart before commercialization. With all these tests, should something deleterious happen with Bt brinjal, there should be post-market surveillance mechanisms for the authorities to call it back. This shows that GEAC has taken due precautions before approving this Bt brinjal on the consumers. All due-diligence care has been taken. "GM-free India" agenda Anti-GM activists have gone to court to see the raw safety data which should be made available by GEAC without much fuss. These kinds of safety data should not be treated as confidential business information. The safety data cannot and must not be treated as confidential business information as there is no justification for the same. The reason the anti's want to see the raw data is to get it reviewed by their own committee of "experts" who in their opinion are independent, and perhaps, even send it to some outside anti-GM experts who will find one thing or another wrong with it and will say how this or another set of tests have not been done, and then go to town crying hoarse that GEAC is not doing its job properly and therefore, stop this GM crop or better, ban it. One can go on doing tests after tests till no end, or do some careful and diligent standardized tests to move the technology forward, and be prepared to take action if something goes wrong. But, that is not what the anti's want. What they want is to apply the "precautionary principle" sensu stricto just so that until and unless all exhaustive tests are conducted including the so-called "long term" health effect studies, no GM food should be commercialized. This makes scientifically no sense and should be dismissed with contempt. Competent scientific experts must advise courts not to heed to this kind of scientific nonsense, and dismiss such frivolous cases out of hand. All these delaying tactics of anti-tech activists is to force developers of GM technology to quit in frustration which would fulfil their "GM-free India" agenda, whatever that means. Segregation and labeling of GM foods Anti-tech activists are ready to launch another protest regarding segregation and labeling which is much contested around the world. Once again, the idea is simple. India's food chain and marketing system is chaotic and unorganized, tracing and tracking is impossible and there will be mixing of GM foods other commodities, and India's regulatory system cannot enforce clear cut separation, and therefore, labeling will be impossible. Because, India cannot segregate and labeling GM foods will be meaningless, ban GM the foods completely. Last month, GEAC did a fine job of allowing importation of inert (non-reproducible) foods derived from GM materials without labeling. A commendable and meaningful decision, indeed. First of all, no one labels commodities, and labeling takes place only in processed and packaged foods to disclose chemical and nutritional composition, and any contra-indications of safety. Segregation and labeling are an additional cost burden that has nothing to do with safety as safety has been assured already by elaborate food safety testing. Moreover, threshold levels of adventitious presence of GM foods or their ingredients are highly contested at the global level. Given that most rules and regulations cannot be enforced in India because of various social, cultural and political reasons, the authorities must be careful not to impose impractical and unenforceable and unnecessary regulations that will not be complied with anyway. For the same reasons, there cannot be any liability laws as it will be very difficult to fix a point source for liability under India's conditions. Moreover, if there is a case to be made against GM foods regarding liability, first damage to the public health or the environment must be demonstrated unequivocally, and that burden of proof is very high. The existing tort law can handle such contingencies very well and there are many case laws where liability has been fixed and penalties and redressal have been awarded in consumer courts in agriculture. In any case, issues of segregation, labeling and liability are all being discussed and debated at various international forum, and India can wait for some modicum of international consensus on these issues before moving in on national regulations. Safe food system Public health through a safe food system is what every nation must strive for. India's food safety system is far from satisfactory with untold number of food adulteration and food poisoning cases. The best way to achieve general food safety is enforce the existing food safety standards and take caution against violators through existing laws. The organic foods and foods produced through chemical and radiation mutagenesis are not evaluated for safety at all. Unlike GM foods, organic foods are notorious for bacterial and fungal contamination and other nutritional problems, but they are not tested for safety by any legal authority, and no one is bothered. Irradiation is well known to scramble the entire genomes and no one can understand what kind of changes take place in fruits, vegetables and food crops that are on the market produced out of this technique. But, when it comes to the most precise recombinant DNA techniques, all anti-tech activists go up in arms, in spite of their proven safety record and preciseness of the technology when compared to organic cultivation and radiation mutagenesis. This clearly shows that the anti-biotech activists have a different political agenda, and they are not really bothered about safety. But, anti-technology activists will argue that precisely because of these reasons, India cannot handle the GM technology, and therefore, ban it. That is like throwing the baby along with the bath water. Indian agriculture and consumers need and deserve all technologies that can benefit them, and all these unscientific reasoning must not be allowed to dictate GM food policy. One thing for sure, regulatory authorities must strive for a greater degree of transparency to usher a new era of increased public confidence in the regulatory system.   ]]> <![CDATA[Bridging the qualitative talent gap]]> https://biospectrumindia.com/news/95/5837/bridging-the-qualitative-talent-gap.html https://biospectrumindia.com/news/95/5837/bridging-the-qualitative-talent-gap.html Tue, 06 Nov 2007 12:16:00 +0530 New Page 1 Bridging the qualitative talent gap Leader Prospects India Pvt Ltd (formerly Nobby Nazareth Associates), is a premier HR consulting firm, with key focus on life sciences and the healthcare industry in India. Leader Prospects since 2001 has been adding value to the industry by constantly studying and analyzing current industry thinking, trends and norms. This year, it conducted a study called the Industry Integration Program (IIP 2007) to find out the ways of bridging the industry-academia gap in the Indian life sciences sector. Leader Prospects' study observed that besides the quantitative growth of campus talent, academia will have to focus on qualitative development of students in terms of the hands-on technical knowledge, adequate industry interface and soft skills training focused on personality development. This will be critical in accelerating campus hiring and thereby addressing a huge human resource challenge in the biotechnology sector. Excerpts of the IIP 2007 study: Leader Prospects India conducted an annual orientation program that was focused on: Technical insight-Getting students acquainted beyond theoretical and syllabi-based intelligence Industry interface-Acclimatizing students to corporate India through adequate industry interaction opportunities and visits Soft skills development-Developing areas of personal development keeping the specific industry requirements in mind. For this study, Leader Prospects identified students to be in three performance categories-above average, average and below average In the experience of Leader Prospects, approximately 70 percent of students fall in the "average" category given the results of their respective university exams. The IIP was aimed at taking this "average" student and moving him/her up the value chain. The results of program is considered exceptional keeping in mind the impact it can have on developing biotech talent in India which is highly scarce.   Composition of IIP Between June 2006 and May 2007, all of the above was incorporated and offered through the Industry Integration Program (IIP) structured as follows: 250 hours of technical training 150 hours of hands on hands-on laboratory training 75 hours of soft skills orientation Exclusive and regular participation of four life science organizations (MNC and Indian) Technical seminars, industrial visits, live projects and subject matter presentations Based on the infrastructure, laboratory facilities and management interest and commitment, Garden City Group of Institutions was chosen for the IIP for the academic year 2006-2007. From various MSc specializations within the college (microbiology, biotechnology, biochemistry and applied genetics), 25 out of 250 students in the above mentioned specializations were identified as the relevant sample size and type. About 25 students under the average category score (40-60%) were selected through group discussions and personal interviews. Out of 25 students, five dropped out during the program on account of personal reasons and hence all graphical representations will show a sample size of 20. The selection process was by and large similar to that followed in the industry in India, with an exception that Leader Prospects identified the students those who came under the "average" score category. The objective of doing this was to understand the impact of the IIP on an "average" performing student. Technical tests: These were designed to assess the basic and fundamental knowledge of science, keeping in mind the general requirements of the biotech industry at the entry level (Duration: 90 minutes and Score: 100 marks). The tests were conducted in two stages: the first test conducted was the preliminary test which was also one of the parameters for selection of students and the second test was conducted at the end of the program, for final assessment. Leader Prospects retained a specialized training firm, Aristogene Biosciences in Bangalore, to work with students to train them on hands-on methods of learning on relevant laboratory equipment. Soft skill tests: SHL, a globally recognized firm in the assessment of soft skills, was retained to do the assessment of the 25 students in two stages: first on selection and next at the stage of final assessment. This test has been recognized as a global standard for assessment, focused on pre-employment. Essential competencies of soft skill test-Communication, teamwork and interpersonal skills, logical reasoning, creating and innovating, planning and organizing Desirable competencies of soft skill test-Presenting and communicating information, writing and reporting, analyzing, adapting and responding to change, and coping with pressure and setbacks Having put together the primary structure to the program, Leader Prospects designed the following process of execution: Technical training: Students were offered orientation in basic sciences that were very fundamental to working on any research. Topics of relevance which are normally taught at the formative years of sciences were a part of this program.   Technical lectures and discussions: Through the program, more than 25 industry/domain expertise professionals from different specializations of science and companies were invited to interact with students. Student presentation: The students were divided into groups and given selected topics like stem cell, gene therapy, biosensor, cancer cells, peptic ulcer. The presentation required the students to extensively research and present facts on the subject matter, current research, application, setbacks, ethical issues, patents and related industry information. The study was focused on taking students beyond the subject matter into more relevant industry issues. Scientists from the industry specializing in research topics were invited to preside over the presentations, comment and judge the students on the same. Hands-on laboratory training: Aristogene Biosciences offered students hands-on experience in the common laboratory techniques. The techniques included basic microbiology and recombinant DNA techniques, advance recombinant DNA technology and PCR, immuno techniques, and techniques in protein purification and analysis Each student performed experiments and worked on each equipment related to the techniques. The objective of this was to familiarise students with laboratory equipment, processes and lab situations. Industry partnership and interface: Leader Prospects retained four biotech firms and invited more than 25 industry experts to interact with the selected students during the year. The four biotech firms were identified and invited based on their status and size, while additional care was taken to identify them from cross-industry specializations, i.e bioagri, bioinformatics, biotechnology and diagnostics. These firms allowed the students to visit their facility to understand not only the research done in the company but also topics like safety measure, corporate ethics and standards. Soft skill support and development: Professional assistance from a qualified student counselor and trainer was retained in doing regular programs during the year with students. These programs were designed at assisting students through group as well as individuated efforts. The IIP focused on building those attributes of the personality which were highly pertinent to an industry environment. About 10 critical areas of development (essential and desirable) were identified with key thrust on communication skills, team work, logical reasoning and quality orientation. Regular programs at the campus included presentations, group work, discussion modules and simulation exercises in the form of personality trait identification, listening, observation, influence of experience, personal style of operating, self esteem and brand identity, team work, goal setting, self involvement and self exploration, aligning vision with reality, choices and changes, and group dynamics Final outcome of IIP Given the efficacy of the IIP conducted through the year, the students who otherwise are categorized into the 'average' category, showed exemplary results. About 50 percent of the students moved up into the 'above average' category (60 percent+) , though the other students also showed increase in their individual score. It is observed that campus trainees below the industry acceptable standards are highly trainable and moldable. Assumption that students below the 60 percent category are not employable may not be entirely right. While the industry may not necessarily need to lower the standards of campus recruiting, the academia has a very large role in moving students in this category up the value chain. It is observed that through the IIP the students influenced their technical score from a 10 percent increase to 50 percent. This percentage of increase is significantly impressive considering the score that qualifies students for selection and employment. It is also possible that by this approach the availability of potentially good candidates can outrun the demand in the industry thus having a direct impact on the hiring cost, thereby retaining the competitive cost advantage of India globally. Industry in India broadly identifies students from the campus at three levels: first, on the percentage score obtained at the university exams, second on the basis on technical assessments designed by individual companies and finally at the stage of personal interviews where students are identified on personal attributes. The IIP increased the score of technical skills in 85 percent of the students and likewise in 60 percent of the students in the soft skills area; increasing the students chances of securing "above average" score in the technical tests of individual companies thereby improving their chances of a gainful employment. Almost 50 percent of the students who were below the 50 percent marks category showed an improvement of 23-50 percent in the technical test performance through this program. Students who were identified in the "bottom of the pyramid" category of the "average" students showed significant improvement to move up into the 60+ percent category. It is estimated that about 30 percent of the students post graduating during an academic year in India would fall into this category. Enhancements in the overall performance of such students through such IIPs could increase the overall scenario of bio talent in India. The soft skills showed very significant increase in students' performance. 16 out of 20 students showed an increase of 23- 31 percent in positive personality changes. Such enhancements in personalities help students in their overall performance, besides helping them at the stages of interviews and at the work place, especially when it comes to interpersonal skills, teamwork and communication. Ironically it was also noticed that there was a decline in scores in the case of four students. It is believed that such self-help programs are aimed to work on the premise of "Help you help yourself" approach. Given the external environment in which the student is operating, a direct influence is created on the personality (positive or negative) and thereby impacting the overall rating of the individual. On retrospection of personal assessment of these students, it was observed that students welcoming the need for change were found to have produced better results in the soft skills test. However, in the final analysis, the program showing positive impact on more than 80 percent of the students was considered noteworthy. Out of 20 students identified for the program, 10 scored over the industry acceptable mark of 60 percent in both technical skills and soft skills. The two attributes that are largely expected from campus recruits at the hiring stages. IPP demonstrates that given the right orientation of technical knowledge, industry interface and soft skills, nearly 50 percent of the students in the "average" category and 35 percent in the overall campus landscape, can be made industry-ready. Considering that India churns out 1,50,000 post graduates annually, the IIP or an equivalent of such programs can significantly increase the percentages of hirable students at the campus level in India. Going by the scale of improvement in students, it is estimated that more than 50 percent of students in the 'average' category can be made industry ready through such programs.   Sabita Rebecca General Managerâ€“Life Sciences Leader Prospects India Pvt Ltd   ]]> <![CDATA[Bridging skills gap in biotech industry]]> https://biospectrumindia.com/news/95/5735/bridging-skills-gap-in-biotech-industry.html https://biospectrumindia.com/news/95/5735/bridging-skills-gap-in-biotech-industry.html Tue, 06 Nov 2007 12:06:00 +0530 New Page 1 Bridging skills gap in biotech industry BioSpectrum presents a study conducted by IIM Bangalore on quantifying the shortage of quality manpower in Indian biotech and recommendations for an actionable agenda. The Indian biotechnology industry recently breached the $2 billion revenue mark and is projected to touch the $5 billion mark by 2010 and $25 billion by 2015. India is poised to become a major player in the international biotechnology industry and biotech could well become the next big Indian success story globally after IT. India's competitive advantage in this sector stems from strong bio-manufacturing skills and the availability of skilled manpower at relatively low costs. The phenomenal growth in Indian biotech has meant that the need for quality trained manpower has also gone up and industry leaders are now complaining about facing a talent crunch. The study aimed at firstly quantifying the shortage of quality manpower in Indian biotech and subsequently recommending an actionable agenda for development of adequate quality human resources with the appropriate skills to ensure that the Indian biotech industry can capitalize on the opportunities before it. Demand and supply of manpower In India, over 250 colleges produce an output of over 10,000 students every year at the various undergraduate, postgraduate and doctoral levels. Over the past five years, capacity addition in the form of new colleges being opened and increased intake in existing universities has been occurring at the rate of about 20 percent year on year and the trend is expected to continue for the years to come. However, the supply levels indicated are those that are intended to serve the Indian biotech industry and not the actual levels. A detailed survey of 46 institutes offering biotechnology courses was undertaken by the authors with the help of BioSpectrum. A significant finding of the survey was that on an average, 42 percent of all students passing out of these institutes opted for higher studies. The survey included institutes from both the publicly and privately funded domains and also covered over 80 percent of the institutes considered to be among the Top 20 in the country (both in the publicly and privately funded domains) by BioSpectrum. About 15 percent of the students were estimated to be permanently lost to the Indian industry as they pursued higher studies abroad and joined the workforce in the West. However, another important factor yet to be considered in all these calculations is the subject of employability of the output. For instance, for every 100 students applying for a job in the industry at the various levels, how many students are considered employable by the industry, both immediately or after some minor orientation and training programs. Through interviews with various CEOs and HR executives in biotech companies, it was concluded that the average employability of graduating students in the country for the Indian biotech sector was about 25 percent only. There were many CEOs who lamented the fact that they had to conduct 100 interviews on an average to select a single candidate and there were also some who felt that the employability estimates were close to 40-50 percent. These significant differences in opinion can be explained by the inherent level of complexity of the business being run and the consequent complementary skill sets being sought by these CEOs in recruits. Thus while the intended supply of manpower is higher than the incremental demand for manpower every year, there exists a huge manpower gap in the Indian biotech sector on account of 42 percent pursuing higher studies and employability being about 25 percent. By 2010, it is expected to be as high as about 14,450 professionals. Reasons for talent crunch Let us first consider the reasons for the low participation rates of graduating output in the biotech sector. The nature of the biotech sector by itself is a major reason for this. The biotech sector being a knowledge intensive sector requires highly skilled manpower and the value for highly skilled manpower is at a premium. It is for this reason that graduating students feel the need to acquire higher degrees and acquire a specialization, as just a basic undergraduate or a postgraduate degree is not valued at all by the industry. This can be derived from the fact that the percentage of students at the undergraduate level being employed is just 28 while at the postgraduate level it is significantly higher at 71 percent. A number of students not opting for higher studies join other industries like IT as the compensation levels are way higher, at times even 3-4 times what is being offered to them by top notch biotech companies. It was observed that most of the students in the country opted for engineering or medicine as a career and it was only those students who couldn't secure admission to these courses who opted for a course in biotechnology. Thus, as the input by itself was not on par with the best talent available, the quality of output was considered average. The content being taught at the various institutes was also found to be obsolete and not in sync with industry needs. There was no national task force focusing on constant upgradation of the curriculum to meet industry needs. In addition to the fact that many students lacked knowledge of the basics, another problem expressed was that even at the MSc level, students did not have specialized knowledge about a particular stream of biotechnology and possessed general biotech knowledge which was essentially an extension of what they learnt at the BSc level. When quizzed about this, some professors admitted that while this may be the case, it was because at the MSc level, even students with a basic degree in BSc Physics or Chemistry were admitted in addition to those admitted through the BSc Biotechnology route. Hence it became imperative that the same concepts taught at the BSc level were reiterated for the benefit of the students who had not studied these topics at the undergraduate level. Also, given the fact that different sectors within biotechnology are considerably different from each other, it is impossible to satisfy the needs of all the companies in terms of tailoring the curriculum to suit the field of work in which they specialize. Faculty-student ratio While the ratio of faculty to students (1:7) as well as the ratio of qualified faculty to students (1:10) are good compared to any other field of knowledge, the key parameters to note here are international publications per year per faculty (0.59) and patents developed per year by the university (2.02). This clearly points to the fact that even though the number of PhDs in the institute is more than half the total faculty, the quality of work being undertaken is not up to the mark. This can be attributed to the fact that the faculty has been unable to constantly stay abreast of industry happenings and practices. One of the biggest problems faced by both the industry and academicians alike is the fact that the equipment or infrastructure required in the biotech sector is extremely costly. The problem is that most institutes in the country today do not possess basic equipment for students to work on and practically understand the various techniques being followed in the industry. The contribution of the government in terms of aid to institutions was found to be an average of Rs 4.90 crore per public institution while the annual contribution of the industry was found to be about Rs 0.24 crore per institution. Thus, the private institutions which faced maximum difficulty in providing quality infrastructure to students neither had funding from the government nor did the industry adequately support them. The institute-industry linkage was found to be poor, barring a few cases. An interesting problem faced by certain students who were technically sound was their inability to communicate well, both in terms of spoken and written language. This also inhibited them from actively participating in team activities to the best of their potential. A major problem expressed by the industry is also the absence of a regulatory scheme laid out by an accrediting body that helps certify the quality of institutes as well as the quality of students which would serve as an indicator for them in terms of recruiting for talent from the best institutes. The mushrooming of many new institutes since 2002 has only added to the confusion. Finishing schools have been envisaged by the Vision Group in Karnataka. The students trained would be MSc and BSc graduates. In the first such initiative, soon be launched with PES in Karnataka, around 100 students would be trained to make them industry ready within a period of one year. The concept is a stellar example of industry-institute collaboration, where the institutes provide the infrastructural support, while the industry provides expertise on latest techniques and more or less ensures absorption of these students in to the workforce. It is highly effective as it ensures that people are immediately employed. This model should be replicated in other places also so that at any given time, a strong pool of quality manpower is readily available, which is readily deployable. Recommendations A basic five-step framework is proposed where the key steps would be to attract, educate, certify, deploy and retrain human resource to b ridge the gap. Various measures that need to be taken are as follows: The Association of Biotechnology Led Enterprises (ABLE) must set up a "Biotech Awareness Fund" with industry support and help increase awareness among the younger people. Women should especially be encouraged to take up careers in biotechnology. Attracting expatriate talent is one of the possible means of developing high-end R&D talent in the biotech sector. Specific tax incentives and resettlement concessions would help make this shift more attractive to target professionals. The number of postdoctoral fellowships offered by the department of biotechnology (DBT) should be increased. Grants for encouraging outstanding talent in biotechnology should be enhanced. Salary support, research grants, lab facilities and opportunities to attend international conferences should be made available. The DBT must promote creation of inter-disciplinary Centers of Excellence (CoEs) with world class infrastructure in key areas. These CoEs must be used to run key advanced programs. A five-year integrated program must be offered that enables students to acquire BSc and MSc degrees in five years. This integrated course should be launched so that an individual can develop domain expertise in a particular biotech area. Also, along the same lines, an MSc degree in applied biotechnology should be offered aimed at specialization in a particular biotech area with total industry focus. Entrance exams for MSc testing basic biotech knowledge are essential for implementing the above and ensuring that the MSc program is a vehicle for specialization, as people from varied backgrounds enroll in such courses. Course curriculum should be reviewed by a body (National Task Force) consisting of members of the UGC, AICTE and DBT in consultation with industry and research establishments. Standard e-learning modules should be developed for specific skill areas such as IPR and regulations. The curriculum should also be updated every two years with specific inputs from the industry on the kind of skills, practices and tools used. Hands-on exposure to MSc biotechnology students should be enhanced through industry internships as well as placements at CSIR and other national institutes. A national task force should be instituted to formulate undergraduate and postgraduate curriculum keeping in view the future needs. This body would also be in-charge of performance testing of students and certification of their performances and accreditation of institutes based on some stringent criteria. It would be the prerogative of this national body to strengthen regulatory mechanisms (legal) and strongly communicate the same to the various institutes and stakeholders. This central body should accredit the institutions based on parameters such as faculty quality, relevance of curriculum and infrastructure. It would also be the prerogative of this body to evolve tests for the graduating students at the postgraduate level so as to certify their capability and maintain a database of their performances which can be shared with the industry helping them pick the deserving candidates. Two levels of testing are recommended. At the first level, common testing for all the graduating students is done to test them on fundamentals and general biotech subjects. At the second level, the test is used to measure competence in the field of specialization. At this stage, various firms can tailor the test according to their needs. This kind of central testing would help save recruitment and training costs for all the companies and reduce their search costs by tapping into the central database of students who have been evaluated. Funding for R&D should shift from plan-based funding and utilization monitoring to project-based funding based on pre-selection of projects. This essentially means that the funding from the government should be a mix of a fixed funding component and a variable one. The basic funding provided by the government to many public institutions should be continued. In addition, an output linked fund must be evolved to encourage those institutes that are producing excellent quality of output. Institutional finance for infrastructure creation should be provided by the government at differential interest rates to private institutions. The option of a person working and pursuing a PhD at the same time should be worked out. Masters degree level professionals in industry should be encouraged to undertake PhD programs while retaining their jobs through industry university tie-ups. Industry sponsored chairs should be created in partnership with the DBT. Scientists and faculty working at universities should be allowed to work in the industry for commercialization of their research efforts. This could be in the form of consultancy projects undertaken in the industry or through the sabbatical route. They should be allowed to hold positions for some time in which their salary is contributed both by the industry and the academic institution. It could be such that a certain number of hours of teaching at the institute are made obligatory. Industry associations in biotech should play a role like what NASSCOM has done for the IT sector. They need to work with the national task force and advise the government on policy. Gautham Krishnan and Rishabh Goel, IIM Bangalore Note: All views expressed are solely those of the authors and do not represent the views of any other person or institution.   ]]> <![CDATA[Indian companies board Lead Optimization bus]]> https://biospectrumindia.com/news/95/2639/indian-companies-board-lead-optimization-bus.html https://biospectrumindia.com/news/95/2639/indian-companies-board-lead-optimization-bus.html Tue, 06 Nov 2007 11:53:00 +0530 New Page 1 Indian companies board Lead Optimization bus The growth of lead optimization outsourcing continues to be fueled by the need for drug developers to bring down costs and speed products to market The drug discovery and development process is getting longer and more expensive. The industry suffers from the same clinical attrition and safety-related market withdrawal rates today as it did 20 years ago. Industrialization of drug discovery from target selection through lead optimization scrutinizes these problems in detail, contrasting the promise of technology and industrialization with the challenges of using the tools available to their best advantage. Global companies in lead optimization AMRI ArQule Argenta Discovery Evotec OAI AG Graffinity Pharmaceutical Design AG Libraria Pharmacopeia Predix Pharmaceuticals Speedel Experimenta AG TransForm Pharmaceuticals Tripos "Lead optimization refers to the structural and functional optimization of drug-like molecules having the potential to be developed as therapeutic agents. This requires the bidirectional collaboration and information transfer between wet lab and dry lab for a productive output. Largely known as computer aided drug design (CADD), a multitude of structural analysis domains interact in this area of research," said MN Manoj, CEO, Jigsaw BioSolutions Ltd, a Bangalore-based start-up. Docking, virtual screening, QSAR, molecular dynamics and real time molecular dynamics (hybridized with quantum mechanics) are some of the latest advancements in the field of structural bioinformatics and to the most they directly or indirectly participate in realm of drug discovery. The pressure is on to get better lead compounds faster and at less cost. The amount of money wasted on leads that fail is very high. And the attrition rate to get a lead is huge. One estimate is that for every 100,000 compounds screened, about 100 hits are identified. Of these 100 hits, only one makes it to the lead compound stage. Between 40 percent and 60 percent of these lead compounds fail ADMET testing. Only 10 percent of IND submissions get approved. Over 72 percent of the costs for drug development are wasted on failures. Company initiatives Major multinationals have established subsidiaries in India. The US and European companies are collaborating with Indian firms to develop new drugs and vaccines, to conduct clinical trials and toxicity studies, to perform molecular modeling and lead optimization, to provide computer services such as bioinformatics, and to develop industrial production processes for new drug ingredients. Similarly, venture capitalists from the US and Singapore are helping to fund start-up biotechnology companies in India. Companies like TCS, Jalaja Technologies, Ocimum Biosolutions, Molecular Connections and Helix Genomics have been providing tools and other services for drug discovery to the biopharmaceutical companies in India and abroad. Strand Life Sciences, a premier in silico technologies innovation company focused on developing technologies for drug discovery and development have launched its SAR modelling and deployment platform-Sarchitect this year. Sarchitect addresses the challenge of taking the model building prowess of computational chemists through to decision support in medicinal chemistry. Two editions of the Sarchitect product have been launched-Designer - for use by computational scientists, and Miner- for in silico lead optimization by medicinal chemists. Strand life sciences also offer high-end custom solutions and technology-based consulting in predictive modeling for lead optimization. Accelrys, a leading provider of scientific business intelligence solutions, has launched Discovery Studio 2.0, an advanced modeling and simulation software environment for drug discovery. The new release features a fully integrated work environment for life science researchers allowing them to go from project conception to lead optimization using a diverse set of sophisticated software applications in a single, easy-to-use environment. Albany Molecular Research (AMRI) which provides extensive resources for drug discovery and lead optimization helps customers identify and optimize lead compounds. Its diverse natural product-based and synthetic chemical libraries which include hundreds of thousands of diverse compounds provide an excellent starting point for a drug discovery program. "We complement our medicinal chemistry lead optimization expertise with technologies in metabolism and biotransformation, including our proprietary combinatorial biocatalysis technology. Our in vitro biology capabilities enable us to identify biologically active compounds from our extensive collections efficiently and rapidly," said Dr Mark Sawicki, director, business development, AMRI. AMRI has a three-year natural products research collaboration focused on screening and lead identification with Eli Lilly and Company. The goal of the collaboration is to discover and develop potential therapeutic agents for diseases of interest to both companies. AMRI has also entered into a two-year natural products-based drug discovery collaboration with Bristol-Myers Squibb Company. AMRI may provide follow-up medicinal chemistry hit-to-lead optimization, biocatalysis or chemical synthesis support on compounds of interest to Bristol-Myers Squibb. AMRI has also recently set up its subsidiary in Hyderabad. Tata Consultancy Services (TCS), a leading global technology services company, assists drug discovery processes from target identification to lead optimization. It addresses four major functional areas-genomics, protein modeling and structural analysis, simulation and drug design, helping researchers with sequence analysis, genome analysis, comparative genomics, 3D modeling, 3D structure manipulations, structural analysis and simulations. In August 2005, Tata Consultancy Services entered into an agreement with Congenia, a biotechnology start-up promoted by Italy's Genextra SpA group, to provide advanced lead optimization solutions for drug discovery. The agreement marked the first of its kind for an IT services company. The Life Sciences R&D Division of TCS works on "P66", a target protein identified by Congenia as a key protein involved in several age-related diseases and will develop optimized drug leads based on the protein. TCS is using modules of its own product, "TCS Bio-Suite," to work on the target protein. Jubilant Chemsys has been offering chemistry based drug discovery and development services ranging from early stage lead discovery and optimization to the identification of viable synthetic routes required to manufacture kilogram quantities of NCE for pre-clinical and clinical studies. Jubilant's services integrate the expertise of its scientists in the areas of drug discovery, drug development and analytical chemistry. Jigsaw Bio Solutions (JBS), a Bangalore based new enterprise, is focused on providing quality end-to-end solutions in bioinformatics domain, including custom software and high performance computing hardware, bundled with professional training. JBS is also exploring the possibility of tapping the contract research projects in various bioinformatics domains including lead optimization. Novel approaches Lead optimization could create a time saving of 18 percent during the drug discovery process, representing significant cuts in R&D expenditure, according to several reports. The key to successful lead optimization lies in adhering to stringent selection criteria during hit generation whilst embracing new technologies that can lead to improvements in screening. Many efforts are underway to make lead optimization less time-consuming and more linear, as well as to bring down the cost of drug discovery and development. The major trend in lead optimization is the different strategies to accelerate the process, such as in silico and high-throughput in vitro approaches. Computational methods can be applied to chemical structures to predict ADMET properties even before the compound is synthesized so that only favorable compounds need be synthesized for screening. Whole cells are also increasingly being used in high-content screening mode to provide selectivity information along with other valuable data concerning the effects of compounds on cell function. New approaches for predicting cytotoxicity, blood brain barrier permeability and active transports in the early stages of drug discovery have also been developed. Technological advances in the development of nanotechnology, miniaturization and systems biology are driving improvements in the refinement of the lead optimization process and cost-effectiveness of drug development. There are more than 25 companies that provide high quality services to the pharma industry helping to improve the lead optimization process. The increasing availability of cheap lead optimization services will benefit pharma companies, enabling more new targets to be investigated without significantly increasing R&D budgets. The formation of strategic alliances will continue to aid drug and technology development as smaller companies license out drugs to bring in revenue. Equally, in-licensing will enable larger companies to sustain and improve profitability but there will be an increasingly high price attached to these projects. In the race to market, companies that provide technologies that go beyond simple data generation to providing knowledge that drives informed decisions will be the most successful. "AMRI is flexible in addressing clients' specific discovery needs" -Dr Michael Trova,Senior Vice President,AMRI -Dr Mark Sawicki, Director, Business Development,AMRI What is the global scenario in lead optimization activity? Lead optimization is a global market. Lead optimization services are coming from the US, EU, Japan and increasingly coming from parts of Asia. The market is spreading across the globe. It has grown successfully over the last 10 to 12 years that we have been associated with this business. The growth in Asia in particular is increasing significantly and this is probably why we have established operations in Asia over the past few years. Lead optimization is a discipline whereby medicinal chemists synthesize one molecule at a time to address specific biological issues, bioavailability, toxicology, absorbtion and distribution. In order to address these biological objectives, medicinal chemists conduct lead optimization process. We need to have experience in addressing such issues and experience is something that AMRI has tremendous in amount. How is AMRI positioned to serve this sector? The real major know-how in experienced lead optimization is something that AMRI has uniquely set up as a service provider to provide something different from its competitors. What we have done to address the global market needs is seen in some of our expansions and growth of our business over the last few years. We had growth in the US but probably not explosive growth as we had 10 years ago. We had significant growth in the lead optimization business and other parts of our business in Asia and Europe as well. AMRI established a subsidiary in Singapore in 2005 and now have around 50 people employed there. The subsidiary in Singapore is focused on lead optimization activity for its customers around the world including the US, Europe and Asia. We also established a subsidiary in Hyderabad in 2005, which has a similar size today and has similar and subsequent growth opportunity and plans. The Indian subsidiary mainly focuses on medicinal chemistry support, intermediate synthesis and also scale-up and chemical development activities. Just last year AMRI bought a company, formerly known as ComGenex, in Budapest, Hungary in Central Europe. It specializes on compound libraries for the lead optimization activity. We incorporated a new location in Budapest as well to assist our global discovery services and activities. Today we have discovery services and activities being operated out of the US, Budapest, Singapore and to some extent India as well. Is there any market figure which you can quantify for this kind of services? Drug discovery and development is a growing market. In particular most of the large pharma are re-evaluating what they exactly want to do internally versus what they want to outsource and that trend has been continuing since the late 1990s. In many cases, a lot of these organizations including large pharma and biotech companies have entered sites and virtual sites they want independently to support all their outsourcing efforts to decide what is their physical sites and outsourcing budget level. The pharmaceutical industry is continuing to grow and they are making decisions to what additional resources they can outsource to give more flexibility to their budgets. The figure at a physical level is very difficult to quantify, but yes, there is a tremendous market. Elaborate on the products that AMRI has been offering for lead optimization? Lead optimization as a discipline is intellectual property driven. The tools used in lead optimization today in many cases are very similar to lead optimization tools we used 5-10 years ago. They include parallel synthesis, ability to make huge number of compounds, new techniques in microfluidics, new tools in computational chemistry as well. All these tools help in selecting targets and validating clinical selection, but the tools in the synthesis side are very largely intellectual based and experimental based. AMRI helps contribute to place dozens of compounds into preclinical and clinical denominants for pharmaceutical partners. For confidential reasons, we cannot disclose who we work for. We cannot disclose what specific targets we work on. That would be violation of their confidentiality. What are the current trends and how do you foresee the future of this industry? The industry will continue to grow with globalization of these types of services and capabilities That is also something we focus on. Now you even see some of our competitors in India are doing the same. They are purchasing facilities in the US and Europe to give themselves a more global presence. As the Asian pharmaceuticals market matures over the coming years, it is going to be more critical to have a global presence. Jahanara Parveen ]]> <![CDATA["Our aim is to identify and develop antiviral drugs against dengue, hepatitis C, West Nile, and yellow fever viruses"]]> https://biospectrumindia.com/news/95/2231/our-aim-is-to-identify-and-develop-antiviral-drugs-against-dengue-hepatitis-c-west-nile-and-yellow-fever-viruses.html https://biospectrumindia.com/news/95/2231/our-aim-is-to-identify-and-develop-antiviral-drugs-against-dengue-hepatitis-c-west-nile-and-yellow-fever-viruses.html Tue, 06 Nov 2007 11:36:00 +0530 New Page 1 "Our aim is to identify and develop antiviral drugs against dengue, hepatitis C, West Nile, and yellow fever viruses" -Dr Daniel Dias, Director, IBM Indian Research Laboratory In an interview with BioSpectrum, Dr Daniel Dias, Director, IBM Indian Research Laboratory, gives an insight into the Discovering Dengue Drugs â€“ Together project, IBM's initiatives towards healthcare and the World Community Grid. When was the project Discovering Dengue Drugs â€“ Together launched? Phase 1 of the project began in August 2007 and will finish in early 2008. Phase 2 will start Fall 2007 and complete by the end of 2008. How does it work? '"Discovering Dengue' project" is distributed using the BOINC client, which is available for download on the IBM site for computers with Windows, Macintosh, or Linux operating systems. The calculations done on World Community Grid will predict which small molecule compounds, out of the millions contained in our library database, will inhibit the flavivirus protease. Phase 1 of this project will predict how each small molecule might bind to the active site of the viral protease. This phase also produces preliminary "energies" that coarsely rank the strength of the intermolecular interactions between the compound and viral protease. Phase 2 will accurately predict free energies of binding between each compound and the viral protease. This calculation utilizes the binding orientations calculated in phase 1. Due to computation time required for each free energy of binding calculation, only compounds with "good" scores from phase1 will be selected for Phase 2 calculations. How far has the vast computational research power been successful in identifying drug molecules for HIV and AIDS? Thanks to the volunteer power of World Community Grid, researchers completed five years of research for the FightAIDS@Home project in just six months, and IBM was able to send the best anti-HIV protease drug compounds to synthetic chemists so they could incorporate them into the design of even better inhibitors than the clinically-approved drugs. This work required quadrillions of computations of 270 protease mutants against a set of 2,000 chemicals that the National Cancer Institute has identified as a "diversity sample," e.g. representing the full variety of chemicals. The initial results from FightAIDS@Home were published in the ACS Journal of Chemical Information and Modeling in a paper is entitled "Analysis of HIV wild-type and mutant structures via in silico docking against diverse ligand libraries." Two additional scientific papers are also in preparation. This project was launched in November 2005 and is expected to run through 2008. How has the World Community Grid impacted research? World Community Grid has a significant impact on research because it can help hasten the progress of projects into further phases of development. For example, on this project, researchers estimate that they would need 50,000 years of compute time on traditional computing devices. Using World Community Grid, research will only take approximately a year. Researchers on the Dengue Fever project credit World Community Grid with allowing them to do more correct science because they don't have to make as many assumptions to conduct the calculations in a reasonable timeframe. As a result, they will have less "false positive" results, be able to study a smaller group of drug molecules that have a better odds of actually working, and thus speed drug development. How does IBM see the future of healthcare and what are some of the initiatives that the company has taken to address the issue? IBM recently announced that it has made available an advanced software technology that can help predict the transmission of diseases across countries and around the globe to the open source co mmunity. The tool will aid scientists and public health officials in understanding and planning more efficient responses to health crises, ultimately providing new tools for protecting population health. The software, known as Spatio-Temporal Epidemiological Modeler (STEM), is now available for use through the Eclipse Open Healthcare Framework Project (OHF), hosted at the Eclipse Foundation, the non-profit foundation that guides the Eclipse open source community. Shalini Gupta   ]]> <![CDATA[IBM helps fight against Dengue]]> https://biospectrumindia.com/news/95/1352/ibm-helps-fight-against-dengue.html https://biospectrumindia.com/news/95/1352/ibm-helps-fight-against-dengue.html Tue, 06 Nov 2007 11:29:00 +0530 New Page 1 IBM helps fight against Dengue The World Community Grid is the world's largest public computing grid to tackle scientific research projects that benefit humanity Finding drugs to treat diseases such as dengue hemorrhagic fever, hepatitis C, West Nile encephalitis, and yellow fever has been a perennial challenge for scientists. Till date there have been no effective drugs to treat these diseases. Consequently, the supportive care necessary to treat these infections and minimize mortality severely strains the already burdened health facilities throughout the world. With this in mind, IBM, along with representatives of the world's leading science, education and philanthropic organizations, launched World Community Grid in November 2004. It is a multimillion dollar investment by IBM to create the world's largest public computing grid to manage scientific research projects that benefit humanity. IBM donated the hardware, software, technical services and expertise to build the infrastructure for World Community Grid. IBM also provides free hosting, maintenance and support. The World Community Grid Harnessing power Millions of personal computers sit idly on desks and in homes worldwide. By 2008, analysts estimate PCs to reach 1 billion. The World Community Grid is a global humanitarian effort that hopes to harness the collective power of millions of individual PCs and business computers so that complex computations can be completed in a fraction of the time typically required. Projects A total of seven projects have been run on the community grid. Five projects are now completed: They are Help Defeat Cancer project, Genome Comparison project, Help Cure Muscular Dystrophy, and the first phase of the Human Proteome Folding project. The two active projects now on the Grid are: Human Proteome Folding project in the second phase and Fight AIDS@ Home. Collaborations IBM has enlisted an advisory board consisting of senior members from IBM, key foundations, academia (with the University of Texas Medical branch and the University of Chicago) and public agencies to review projects submitted via the RFP. The goal is to assure that World Community Grid resources are focused on research that has the greatest impact and support work that might otherwise be bypassed in favor of more commercial projects. Discovering Dengue Drugs - Together The University of Texas Medical Branch and the University of Chicago have joined hands with World Community Grid researchers to combat some of the most widespread viral diseases under the project "Discovering Dengue Drugs-Together." This project will discover promising both broad-spectrum and specific antiviral drugs that stop the replication of viruses within the Flaviviridae family responsible for dengue hemorrhagic fever, hepatitis C, West Nile encephalitis, and yellow fever. The approach These viruses can be combated from causing diseases by developing drugs that inhibit the viral NS3 protease. The NS3 protease is an enzyme critical for virus replication, and its amino acid sequence and atomic structure are very similar among the different diseaseâ€“causing flaviviruses. Since the atomic structure of the NS3 protease is known, advanced structureâ€“based computational drug discovery methods can be used to identify small molecule protease inhibitors. Dr Stan Watowich and his research team at the University of Texas Medical Branch (Galveston, Texas, USA) have made significant progress in this direction, having discovered compounds that inhibit dengue and West Nile virus proteases and prevent virus replication in cell culture. However, additional drug candidates need to be discovered to improve the likelihood of converting drug leads into approved drugs for treating flavivirus infections. How it works Using the megacomputing power of World Community Grid, researchers at the University of Texas Medical Branch will complete extensive drug discovery calculations that will accurately predict binding free energies (a measure of how strongly molecules interact) between small drug-like molecules and different flavivirus NS3 proteases. In Phase 1 of this project, AutoDock will fit over six million small molecules to each of the flavivirus NS3 proteases, so optimal binding orientations can be identified. AutoDock, developed by Dr Arthur Olson of The Scripps Research Institute (San Diego, California, USA) can predict how small molecules might fit into a binding "pocket" on a protein of known atomic structure. These docking calculations will provide orientations for each small molecule-protease complex and a preliminary metric to discriminate between possible protease inhibitors and non-binding molecules. In Phase 2 of this project, potential protease inhibitors predicted by Autodock will be organized into a concise database for detailed analysis with CHARMM, a molecular dynamics program developed by Prof. Martin Karplus and his colleagues at Harvard University (Cambridge, Massachusetts, USA). Accurate CHARMM-based mean field binding free energy calculations will be applied to all potential protease inhibitors. The post-processing of the initial fitting results with binding free energy calculations will significantly reduce false-positive rates, thus speeding discovery of potent protease inhibitors. Novel compounds predicted to be high-affinity inhibitors of flavivirus proteases will be tested in laboratory assays for antiviral activity. Running these complex drug discovery calculations on World Community Grid will dramatically reduce the time required to complete this computationally intensive project. Dengue virus (DENV) infects 50 million (WHO) to 100 million (NIH) people annually. Forty percent of the world's population, predominately in the tropics and sub-tropics, is at risk for contracting dengue virus. Dengue fever is a severe, fluâ€“like illness typically accompanied by very high fever and severe joint pain. Dengue hemorrhagic fever is a frequent complication of dengue virus infection, characterized by intense fever, internal bleeding, and circulatory failure; death occurs in 5 percent of patients. In India specifically, Dengue fever has affected more than 46,000 children and adults between 2001 and 2006 of which almost 700 were fatal. Delhi and Rajasthan alone accounted for 43 percent of the cases Shalini Gupta ]]> <![CDATA["We cater to specialized doctor segments"]]> https://biospectrumindia.com/news/95/1930/we-cater-to-specialized-doctor-segments.html https://biospectrumindia.com/news/95/1930/we-cater-to-specialized-doctor-segments.html Tue, 06 Nov 2007 10:57:00 +0530 New Page 1 "We cater to specialized doctor segments" -Sandeep Gupta, Chairman and Managing Director, Eli Lilly & Company India Eli Lilly & Company India clocked sales of around $40 million over the last year and grew at a rate of around 20 percent. The company recently came up with a new drug for the treatment of type 2 diabetes that is one of its kind. BioSpectrum caught up with Sandeep Gupta, medical director, Eli Lilly & Company India. Excerpts from the interview: What is the product portfolio of Eli Lilly in India? Our basic model in India is that of being present in the specialty product segment. In other words we do not have many products which we could call mass products. It also means that we cater to the specialized doctor segments and not general practitioners. We are basically into four broad areas as under. First and foremost is our diabetes care business that comprises 60-65 percent of our entire sales turnover. Under this category we have a whole range of products including human insulin (cartridges and vials) and human insulin analogs. We have just launched Byetta (exenatide) for type 2 diabetes. We are also into oncology segment wherein we have two products. There are two products also in the critical care business: one aimed at improving outcomes after coronary angioplasty (heart) and the other used in treatment of severe sepsis. In the area of women's health we have a drug for the treatment of severe osteoporosis. What have been the major product launches in the last one year? We have had three product launches over the last one year. The first one was the launch of Humalog (insulin lispro) disposable pen, which is an advanced disposable device that offers convenience to patients. It is a prefilled injection. Next in line, we launched Alimta (pemetrexed), which is for the second line treatment of NSCLC (non small cell lung cancer). Very recently we launched Byetta (exenatide). How is the company focusing on R&D? Lilly is at the forefront in terms of its strong focus on R&D. Almost 20 percent of our revenue globally is ploughed back in R&D. As a company we have decided to focus on four therapeutic areas-endocrinology, oncology and cardiovascular and CNS. What are your future plans in India? In line with our global strategy, we have plans to introduce more products in the area of diabetes, oncology, cardiovascular and women's health segments. Depending on the regulatory approval timelines, we may be launching 6-7 products over the next five years. Our growth will be mainly driven by the introduction of these new products. At the rate at which we are growing currently, we should be double than what we are today in the next 4-5 years. What differentiates Lilly from its competitors? Our biggest differentiator is in the kind of people that work for Lilly. We take pride in the people that we select for our company after a long drawn selection process. The training that we give our employees is not a one-time activity; instead a considerable effort is put in up-gradation of skill sets on an ongoing basis. Because of our significant focus on the continual training and development of our employees, we enjoy a very strong image amongst the different customer segments. We also take pride in conducting our business in very ethical manner. In fact, we set very high standards for ourselves and have set an example before the industry in terms of ethical product promotion. Another aspect that probably sets us apart is our relentless focus on product safety eventually leading to patient safety. As a company we are constantly striving to take these practices to the next level. How is Byetta different from other products that you have in your diabetes treatment portfolio? Byetta (exenatide) is an absolutely new class of therapy. The product belongs to a new category called, Incretin mimetics. Secondly, Byetta is not insulin, even though it is injectible. The product is a unique treatment option for type 2 diabetics specifically for those patients who are on OHA's (oral hypoglycemic agents) like metformin or a sulphonylurea or a combination of both and not adequately well controlled. Byetta also reduces appetite and slows down the passage of food through the stomach and intestine and as a result, the absorption of food gets delayed. As we commonly know, weight control plays an important role in the management of type 2 diabetes. In this context, this drug offers dual benefits to the patient. Not only does it help in controlling blood glucose, it also helps a patient lose weight. However, I would like to stress that this is not a weight loss drug. Moreover, Byetta comes in two strengths-5mcg and 10mcg. We recommend putting a new patient on Byetta at the lower dose of 5mcg and subsequently migrating this patient to 10mcg after about a month or so depending on clinical assessment of the treating physician. In this context, unlike insulin therapy, that may require significant dose titration, Byetta offers another unique benefit of a fixed dose. Where all has Byetta been launched in the world? India is the fourth major country in which Byetta has been launched after its launch in US, UK and Germany. What about the pricing? The price of a 10 mcg pen is Rs 7,900 that lasts for a month. Byetta comes in a pre-filled injection that is very easy and convenient to use. How Byetta works In type 2 diabetes, there is a deficiency of insulin because the body is not able to produce enough insulin. One of the reasons why this happens is because one of the naturally occurring hormones in the gut called GLP (Glucagon like peptide) also becomes deficient in this state. GLP normally stimulates the pancreas to produce insulin in a glucose dependent fashion: insulin is released with glucose level go up and insulin release stops once glucose level returns to normal so that chances of hypoglycemia get minimized. In patients with type 2 diabetes, Byetta (exenatide) mimics the action of this naturally occurring hormone, GLP. What about the marketing strategy for the product? As Byetta belongs to a new class of compound, we are being extremely cautious in our promotion. Specifically, we are confining the promotion of this product to doctors who specialize in the treatment of diabetes. We also strongly recommend that only the right patient should be selected for this therapy. This may effectively mean restricting our market but that is a conscious decision that we have taken. Any target that you have set for the drug? It will be difficult to estimate with certainty the market size of this compound because as I mentioned before, this belongs to an entirely new class of agents. However, there are approximately 40 million diabetics in India out of which 95 percent are type 2 diabetics. Out of that there is a large patient population that are overweight and are not responding adequately to OHAs. Such patients would benefit most from this new drug. Shalini Gupta ]]> <![CDATA['Melbourne aims to be among the top five biotech hubs in the world']]> https://biospectrumindia.com/news/95/3473/melbourne-aims-to-be-among-the-top-five-biotech-hubs-in-the-world.html https://biospectrumindia.com/news/95/3473/melbourne-aims-to-be-among-the-top-five-biotech-hubs-in-the-world.html Tue, 06 Nov 2007 10:50:00 +0530 New Page 1 'Melbourne aims to be among the top five biotech hubs in the world' -Gavin Jennings, Minister for Innovation, Victoria Government, Australia The state of Victoria released a 2007 Biotechnology Strategic Development Plan, at AusBiotech 2007. Through this plan, the Victorian government will take action to drive growth across biotechnology sectors. Gavin Jennings, Minister for Innovation, Government of Victoria, Australia, who released the 2007 Biotechnology Strategic Development Plan, aims to take Melbourne to the top position in the biotechnology world. Some excerpts from the interview: What is the strategy you are deploying to make Melbourne one of the top five biotech clusters in the region? Melbourne aims to be one among the top biotechnology hubs in the region. To achieve this, we are banking on building infrastructure, research capacities and intellectual capital, and make partnering connection between researchers and people who take up research beyond early innovation stage to the clinical trial and commercialization stage. We want to continue to build up that infrastructure as much as we can. We have evidence to show that there is an increase in area of research and innovation. There is an increase of 66 percent in terms of investments critical to mass of people who operate from Melbourne. Our biotechnology industry is valued at over A$21 billion. How much investment Victoria government has made to develop the growing biotechnology industry? The government of Victoria has invested A$2 billion in the last six years in the innovation space, which is combination of medical device and biotechnology space including the infrastructure development. AusBio 2008 Melbourne to host AusBiotech 2008 Melbourne is capital of Victoria. Victoria is home to 141 biotech companies, 15 major medical research institutes, seven teaching hospitals and nine universities Melbourne has joined London and Boston as one of the only three cities in the world with two universities in the global top 20 rankings. Novotech invests $7 m to set up India office Novotech, Australia's largest Contract Research Organization (CRO) will set up operations in Mumbai, India with an investment of about $7.2 million. The Mumbai office will be the first Asian operations for Novotech to be operational by the end of this year.  Alek Safarian, CEO, Novotech said, "Many of our US clients are looking at entering Asia, and so offering a seamless operation serves a growing client base from the Australian and American regions. Novotech is highly regarded in the US and the EU for managing the Australasia/Asia Pacific component of global trials, and a stronger presence in Asia would further guarantee the Novotech stamp of excellence in high standard, speed, efficiency, and reasonable cost trials." Narayan Kulkarni in Brisbane, Australia   ]]> <![CDATA[Brisbane attracts top biotechs]]> https://biospectrumindia.com/news/95/1549/brisbane-attracts-top-biotechs.html https://biospectrumindia.com/news/95/1549/brisbane-attracts-top-biotechs.html Tue, 06 Nov 2007 10:38:00 +0530 New Page 1 Brisbane attracts top biotechs The sixth edition of Australia's largest annual biotech event "AusBiotech 2007" in Brisbane attracted over 1,300 visitors from across academia, government agencies and private sector. Brisbane, the capital of Queensland, is a hub for the biotechnology and pharmaceutical industry in Australia. Brisbane boasts of world-class hospitals and medical and research institutes offering a highly competitive cost of research and development, clinical trials and manufacturing. Phylogica takes burns drug into human trials Australian drug discovery and development company Phylogica has said that its underdevelopment burns drug, PYC35B will progress to human trials in 2008. Phylogica CEO Dr Stewart Washer said the company had received good results from the latest pre-clinical study conducted independently by Fiona Wood's McComb Foundation. "The dose response study using the Phylomer peptide D-PYC35B in a mouse wound repair model found that at a low concentration (3 micromolar) there was a significant improvement in both the rate of wound healing as well as a significant reduction in the size of scar formation," Dr Washer said. Welcoming the delegates and exhibitors to the four-day national biotech conference and exhibition themed "Smart Targeting Into Global Markets", Desley Boyle, Minister for Tourism, Regional Development and Industry for Queensland, said "We are proud that last year, the world's first cervical cancer vaccine, Gardasil was launched following a discovery by Queensland scientist Prof. Ian Frazer. Queensland scientists are now working on projects like painkillers from a marine shellfish; cancer treatments from kangaroo bacteria; unmanned aerial vehicles with robotics inspired by bees; using algae to produce hydrogen as a fuel; DNA testing to find the most tender beef cattle; organ, bone and tissue regeneration; growing your own replacement arteries; a skin patch that delivers vaccines and a new drug that inhibits fat cells." Queensland companies have 23 lead candidates in drug development, with a good number of these going to phase III clinical trials. Dr Anna Lavelle, CEO of the biotechnology industry umbrella group, AusBiotech informed that at this event there were about 400 international visitors and over 87 international speakers. "The event is now on the radar of big pharmas looking for partnering and investment opportunities," Dr Lavelle said. At the event, the top 12 pharmas were present as were the top five biotech companies. Over 130 exhibitors from India, Italy, Korea, Malaysia, Japan, Taiwan, New Zealand, China, United Kingdom and Canada participated in this mega biotechnology event of Australia. The next AusBiotech will be held from October 26-29, 2008, in Melbourne. Capital of the state of Victoria, Melbourne is home to CSL and Sigma Pharmaceuticals-Australia's two largest listed companies. Narayan Kulkarni in Brisbane, Australia   ]]> <![CDATA[Italy beckons Asian biotechs]]> https://biospectrumindia.com/news/95/3839/italy-beckons-asian-biotechs.html https://biospectrumindia.com/news/95/3839/italy-beckons-asian-biotechs.html Tue, 06 Nov 2007 10:32:00 +0530 New Page 1 Italy beckons Asian biotechs Italy is known for its fashion, design and engineering industries, besides the mouth-watering pizzas, pastas and olive oil. The country also has a vibrant biotech sector, with 222 companies and annual revenues of $6 billion and annual investments to the tune of $2 billion. To take it to the next stage, Italy's biotech sector, mainly made up of small and medium-sized companies, is on the lookout for global partners. A special report on Italy's outreach efforts. There is no doubt Italy's industrial sector is aggressively wooing Asian companies. In fact, various chambers of commerce in the country, along with industry organizations, wooed Indian industrialists by organizing a "Namaste India 2007" (Welcome India) event in the last week of September to showcase Italy's capabilities in different segments. Pharma and biotech had a prominent share in the showcase. "Despite our different historical and economic backgrounds, there are many similarities and complementarities between Indian and Italian economies. Namaste India 2007 is an attempt to focus on the sectors in which one country's know how and expertise can bring a more evident 'added value' to the other: from infrastructure development to environment and food processing to ICT and biotech," said Italian ambassador to India, Antonio Armellini. Canavese: A unique bioindustry park There are over 100 bioscience parks around the world and many more are under development. Among them, the BioIndustry Park, at Canavese, just 50 km outside Turin, nestling in the foothills of the picturesque Alps mountain range, stands out for its uniqueness. Developed in 1998, the Park is an example of public private partnership with a number of regional institutions involved in its founding. Its uniqueness comes from the facilities it provides to entrepreneurs. "A potential entrepreneur has to just walk with a good business idea. Everything else required to make it a commercial success is provided by the park," said Kevin Roman, a technology transfer manager of the Park. In fact, what is on offer is a lot more than the conventional incubator. The researcher can straightaway get into the well-equipped lab, and start working. Just incorporate the company and the park's venture fund will take care of finances. The Park will also take care of all the administrative and other logistics of the company. The Park also assists in the spin-off and growth of innovative companies. Over 35 organizations and research centers are hosted in the park. The prominent ones are Bracco (Italian R&D center), Creabilis Therapeutics, Merck-Serono's preclinical facility, Eporgen Venture (Italy's first seed capitalist specializing in biotech), LIMA (a lab hosting scientists from various universities) and eight new drug discovery startups. So far it has supported 40 organizations and 18 startups. More than 500 scientists are working in 1 sq km area, making the Park the venue of the biggest concentration of biotech professionals in northern Italy. Eporgen, the Park's VC company, has supported seven startups so far. " It is a big opportunity for India's biotech researchers to start their entrepreneurial ventures from here," invited Simone Zanole, a business development manager at the park. Biotech powerhouse The 222 Italian biotech companies employ over 14,000 people with a strong emphasis on research and development (R&D). According a report by the Italian Chamber of Commerce, over 35 percent of biotech sector employees in small companies are researchers. Nearly 80 percent of the industry's $6 billion revenues come from a few large companies like Roche, Novartis and Syngenta. The Lombardy region has the highest concentration of R&D activities, relying primarily on innovation. "This region leads Italy in scientific research and ranks 11th amongst 25 European locations for R&D expenditure," said Lionella Bertazzo, a senior official at the Milan Chamber of Commerce. Milan is in the Lombardy province. "Attracting investments is becoming more and more important. Nearly 43 percent of the exports from the region are in high-tech areas," she added. Accounting for 45 percent of Italy's biotech industry market cap, Lombardy has a fast growing presence of science and technology parks such as "Parco Technologicco Padano", which has companies in the green biotech, bioinformatics and bioagri sectors. The Park Science Raf specializes in biomedical research. Milan accounted for 23.58 percent of European patents filed from Italy in 2005 and 12 percent of the national patent applications filed in the chemical and biotech sectors. Some of the promising companies located in the Milan region are Nerviano Medical Sciences, a spin-off from Pfizer and working on anti-cancer drugs, TOP (Transgenic Operative Products), a spin-off company of University of Milan working on novel animal models, LEABiotech, another University of Milan spin-off, specializing in genomic technologies; and Dialectica, which is developing neural stem cell-based systems and assays for neurogenerative diseases. Biotech in Tuscany Tuscany region, which has the prominent city of Florence, is another biotech powerhouse accounting for 10 percent of the country's biotech investments with 23 well known companies. Companies such as Abogen Pharma and Menarini are located here. Officials at the Chamber of Commerce in Florence said scientific parks such as the Toscana Life Sciences and TIs Science Park, which has over 350 researchers and a modern biotech incubator to house eight companies is strong point of the region. The University of Florence, several clinical research institutes and institutional investors were also great supporters of biotech industry. Said Prof. Claudio Luchinat, scientific advisor to a biotech hothouse start-up Protera, "Earlier, there the academic culture was not very supportive of the transfer of scientific developments to the industry. Things have started to change rapidly in the last 10 years. Though investment-friendly laws were not there to translate academic research into successful products, things are changing very fast." Prof. Claudio's company was promoted with strong support from the Chamber of Commerce of Florence, University of Florence, some local banks and the researchers at the Magentic Resonance Center (CERM) of the University of Florence. Incubated at CERM, Protera intends to build aggressively on its technological platform and to apply it to selected protein targets. Turin: Not just aerospace The Pieomonte region, which includes Turin, is known for the aerospace and automobile (FIAT is based here) industries. Biotech too has strong roots in this northern Italian state bordering the Swiss Alps. "Piemont accounts for 14 percent of the country's biotech companies and six percent of researchers," said the Turin Chamber of Commerce and Industry Secretary General, Guido Bolatto. The University of Torino, founded in 1404, is an active supporter of biotech research. A Molecular Biology Center was set up in 2006 to integrate all the research efforts in the biomedical field within the university. The Piemonte region has around 150 life science companies and another 350 are engaged in the biomedical sector. More than 800 students graduate in life sciences in the region annually and investments top the $100 million mark every year. This is just the beginning of the exploratory process for partnerships with companies and institutions outside the region. Sergio Sgambato, Secretary General of the Indo-Italian Chamber of Commerce, based in Mumbai, India, said a big biotech industry delegation may visit the country during the Bangalore Bio event in April 2008 to take forward the discussions between the business leaders of both the countries. Narayanan Suresh in Florence, Turin & Milan   ]]> <![CDATA[25years of Humulin, the first genetically engineered drug approved by the FDA]]> https://biospectrumindia.com/news/95/8441/25years-of-humulin-the-first-genetically-engineered-drug-approved-by-the-fda.html https://biospectrumindia.com/news/95/8441/25years-of-humulin-the-first-genetically-engineered-drug-approved-by-the-fda.html Tue, 06 Nov 2007 10:26:00 +0530 New Page 1 25years of Humulin, the first genetically engineered drug approved by the FDA Till date, insulin therapy is the only effective treatment for Type 1 diabetes and is also generally required for the treatment of Type 2 diabetes as the disease progresses. Insulin was isolated for the first time in 1921 from animal sources and commercialized within 12 months. Decades later, it took just four years for developers to move from expressing recombinant insulin in bacteria to launching the world's first biotechnology drug product. Composition Insulin consists of a 21-amino acid A chain and a 30-amino acid B chain, linked by two disulfide bonds. It can be produced either by generating the chains separately and chemically combining them or by creating a single-chain precursor, human proinsulin, and cleaving out a 35-amino acid connecting peptide. For manufacturing the drug, the proinsulin route is favored because it requires a single fermentation and isolation step. A breakthrough In 1978, the US-based biotech company Genentech and City of Hope National Medical Center, jointly produced human insulin in the laboratory using recombinant DNA (rDNA) technology. City of Hope scientists had synthesized the genes for the protein's two chains before inserting them into Escherichia coli.With its expertise in purifying and handling insulin and the desire to remain a leader in the field, Lilly, a US-based pharmaceutical company, immediately licensed recombinant insulin from Genentech and set about developing it. Fortunately, Lilly also had experience isolating antibiotics from fermentation processes. Because rDNA guidelines at the time allowed the expression of only inactive protein products, Lilly had to use the two-chain method. Clinical studies began in 1980. In 1982, Lilly's Humulin became the first genetically engineered drug approved by the US Food and Drug Administration. The US approval came just one month after British regulatory authorities allowed its introduction in the UK. Although the development of Humulin took just four years, it was a major undertaking for both the developers and regulators, breaking new ground. Humulin was the first drug produced by genetic engineering techniques to gain the FDA approval for human use. It was made by inserting human genes responsible for insulin production into E. Coli bacteria, thus stimulating the bacteria to synthesize insulin. Because this technique could produce large quantities of insulin, the artificial insulin was expected to help alleviate a shortage of animal insulins predicted to occur within the next decade. Humulin had proved to be safe and effective in FDA clinical trials involving more than 400 patients. It is used by more than 4 million people with diabetes around the world everyday. Today Humulin is available in both a vial and a disposable prefilled pen and this helps in choosing a convenient way of taking Humulin. The pioneer Today Genentech is a purely biotechnology company that discovers, develops, manufactures and markets human pharmaceuticals produced by recombinant DNA technology for significant unmet medical needs. More recently, producers have used genetic engineering to create insulin analogs that differ in a few amino acids as a way to control their onset and duration of activity. Technological developments DNA technology has led to the ability to synthesize insulin analogs. To date, more than 300 insulin analogs have been produced. The purity of insulin has increased and the needle size for injections has decreased, thus reducing the discomfort associated with subcutaneous insulin injections. Traditionally, diabetics who use insulin have to inject themselves via a syringe. However, alternative approaches for insulin delivery, including nasal and oral methods, are being studied. Biocon Ltd, India's premier biotechnology company, has recently presented the results of Phase I studies on the oral insulin product-IN-105, a novel analog of insulin at the European Association for Study of Diabetes (EASD) meeting held at Amsterdam. The product has special properties that make it feasible for delivery of insulin in tablet form. Alternatives to syringe injections may help ensure patient compliance to insulin therapy by making insulin delivery easier and more convenient. New technologies are also under development to provide automatically controlled insulin delivery. One such device uses a glucose sensor implanted into the patient. The production of human insulin through recombinant DNA technology represented an important advance in the treatment of patients with diabetes. The increased incidence of diabetes, coupled with the introduction of alternative delivery methods that rely on higher doses, is expected to result in a substantial escalation in the demand for affordable insulin in the future. ]]> <![CDATA[Biotech manufacturing in India on a roll]]> https://biospectrumindia.com/news/95/2126/biotech-manufacturing-in-india-on-a-roll.html https://biospectrumindia.com/news/95/2126/biotech-manufacturing-in-india-on-a-roll.html Tue, 06 Nov 2007 10:25:00 +0530 New Page 1 Biotech manufacturing in India on a roll India is fast emerging as a favored destination for biopharma manufacturing Indian companies like Biocon, Bharat Biotech, Biological E, Serum Institute and Shantha Biotechnics have world-class facilities for biopharmaceutical manufacturing. Earlier there was some reluctance to award contracts to Asian biopharma manufacturers because of concerns of IP and regulatory compliance. But now some of the Asian countries are changing and becoming very competitive in biopharma manufacturing. "Indian firms are expanding and scaling up manufacturing capacities to become global players and the West is increasingly becoming comfortable with the IP, quality, regulatory filings and the infrastructure here," said Gautam Das, COO, Syngene. Shasun Chemicals, Suven Life Sciences, Strides Arcolabs, Jubilant Organosys, Orchid Pharmaceuticals and many other large Indian companies have started undertaking contract manufacturing of APIs as part of their additional revenue stream. Top MNCs like Pfizer, Merck, GSK, Sanofi Aventis, and Novartis are dependent on Indian companies for many of their APIs and intermediates. Today Indian pharma companies have upgraded their existing plants or built new plants which are not only GMP compliant but also approved by international drug authorities. Many mid to large-sized ones have achieved GMP approval of highly regulated markets such as the US, Europe, Australia, Latin America and Canada. The most stringent, the USFDA approval is distributed between large and mid size companies. India triumphs in having maximum number of USFDA approved plants after the US. India has over 80 USFDA approved plants and all comply with WHO GMP. India is expected to have 30 percent more USFDA plants by 2008. The large portion of this increase will be shared by mid size pharma companies. Most of the companies are upgrading and building new facilities as per USFDA standards. Apart from Andhra Pradesh and Gujarat, Himachal Pradesh is the next favored state for setting up manufacturing plants. India comes fifth in terms of API manufacturing. It has established itself as low cost and high quality API production country. With product patent regime in its second year and several products expected to go off patent in the next 2-3 years, India is well positioned to capture the outsourcing opportunity. With India emerging as a cost competitive outsourcing base for global majors, Jubilant Organosys, an integrated pharmaceutical and custom research and manufacturing services company, intends to be the preferred partner for custom research and manufacturing to global leaders in the pharmaceuticals and agrochemicals industry. Jubilant Organosys recently signed a multi-million dollar long-term agreement with Syngenta for the supply of pyridines. The new contract will begin from early 2008 and it will cover an extension period of up to five years, during which Jubilant will continue supplying the products to Syngenta. Recently Jubilant expanded its production capacity for pyridines and picolines to 42,000 TPA and this contract with Syngenta would significantly improve the use of the additional capacity. With this multi-year contract and increased capacities, Jubilant emerges as the largest player in pyridines worldwide. Jubilant Organosys have also acquired US-based Hollisterâ€“Stier Laboratories LLC for $122.5 million. This is said to be the largest overseas acquisition in contract manufacturing sector by an Indian company. The acquisition significantly strengthens Jubilant's global CRAMS business via entry into the high barrier injectables segment. Hollister is an excellent strategic fit for Jubilant, as it augments the company's growth in the CRAMS business globally. This acquisition provides Jubilant with a platform within the fast growing injectables contract manufacturing segment. The company had signed annual contracts worth $60 million. The contracts form part of the company's order book for the calendar year 2007. The contracts have been finalized with some of the leading global life sciences companies in the US and Europe. In addition to these annual contracts, the company as part of its normal business also executes half yearly, quarterly and monthly contracts and spot sales. The company will also focus on twin strategies of investments in innovation and world-class manufacturing facilities. Currently, Jubilant is in advanced talks with other global life sciences companies and is confident of signing several other contracts for CRAMS over the next few months. Over the last two years, Jubilant Organosys has invested close to $45 million on augmenting its manufacturing capabilities and strengthening its R&D backbone in customs research and manufacturing business. Hyderabad-based Suven Life Sciences, a pioneer in Contract Research and Manufacturing Services (CRAMS), received NABL (National Accreditation Board for Testing and Calibration Laboratories) certificate by the Department of Science and Technology (DST) last year, for its biopharmaceutical research lab facility at Hyderabad with the standard ISO/IEC/17025:2005 (general requirements for the competence of testing and calibration laboratories). With this NABL certification, Suven is in a position to offer value added services within the business segment of CRAMS, Drug Discovery and Development Support Services (DDDSS) and Collaborative Research Partner (CRP). Suven Life Sciences recently underwent USFDA inspection at its facility in Hyderabad for the manufacture and supply of Active Pharmaceutical Ingredients (APIs) under cGMP. Based on the inspection and the review thereafter, the USFDA classified Suven's facility at Pashamylaram as acceptable for manufacture and supply of APIs. So far Suven Life Sciences has filed 8 Drug Master Files (DMFs) from this facility, which is now USFDA compliant under cGMP. With partner ANDA approvals Suven can supply the APIs in future thus generating new revenues in due course of time. Last year, Kemwell, a Bangalore-based contract manufacturing and development services company, acquired Pfizer's manufacturing plant in Uppsala, Sweden. The facility produces salazopyrine known as the first designer drug used to treat arthritis and irritable bowel syndrome (IBS). This is not the only acquisition made by Indian life sciences companies and will neither be the last. Nicholas Piramal has done an acquisition in the UK and Dr Reddy's Labs has bought a Roche facility in Mexico. However, the acquisition by Kemwell is a good indicator that medium-sized Indian companies also have the opportunity to be global players. According to Anurag Bagaria, vice president of Kemwell, the acquisition enabled the company to gain the vital European footprint for its contract manufacturing ambitions. Being close to the customer is a mantra being heard increasingly in the life sciences sector. The Kemwell acquisition of the Pfizer plant, which is approved by the USFDA, the European EMEA and the Japanese regulator, is also believed to have been driven by this mantra. "We service 80 countries from our Uppsala facility and this acquisition has helped in increasing our credibility in the international market," said Bagaria. Though the contract with Pfizer is a long term one, Kemwell is in a position to manufacture other drugs as well in this facility. "We will use this facility to do the lab tests for medicines manufactured in India and to be sold in EU. We continue to look for more acquisitions in Europe and the rest of the world," added Bagaria. At present over 80 Indian pharmaceutical formulation plants have received USFDA approvals. Companies such as Lupin, Biocon, JK Pharma, and Ranbaxy got the USFDA approvals for manufacturing few of their fermentation products. Also global majors like GSK and Aventis are setting up manufacturing bases here. Serum Institute of India is widely recognised as a world-class contract manufacturer and is able to deliver a wide range of products and clinical assistance to companies on a market competitive basis. In particular, Serum Institute has developed a complete process of fermentation, purification and manufacture of polysialic acid and the Development and Manufacturing Agreement (DMA) provides the framework for this process to be taken forward to enable production on a competitive commercial basis. Lipoxen PLC, a UK-based biopharmaceutical company specialising in the development of differentiated biologicals, vaccines and anti-cancer therapeutics drugs, entered into a Development and Manufacturing Agreement with the Serum Institute of India. Pursuant to the DMA, Serum Institute develops the technology for the manufacture of polysialic acid and its derivatives to the USFDA standards on a commercial scale to meet the demands of the company's collaborative partners and for pre-clinical and clinical trials purposes. Serum Institute of India is setting up a biotech Special Economic Zone (SEZ) at Pune with an investment of $265 million. About one billion doses of various vaccines are expected to be produced on an annual basis from this SEZ. Oncological products for the US and EU markets are also expected to be manufactured at the new facility. The premises has been pre-qualified by the WHO. Bharat Biotech, Dr Reddy's Labs, Intas Pharmaceuticals, Panacea Biotec, Shantha Biotechnics, and Wockhardt are some of the other companies that are manufacturing rDNA products in India. Others like Glenmark Labs are serious about setting up manufacturing facilities for recombinant biotech products. Haffkine Bio-Pharmaceuticals, Hindustan Antibiotics, Shreya Life Sciences, and US Vitamins have been into formulation business so as to produce for mass consumption. Biological E, which is looking at increasing its revenue from the biotech area, is increasing its capacity and setting up a modern vaccine facility in Hyderabad. Indian Immunologicals Ltd (IIL), a major player in animal vaccines manufacturing, has been making investments in infrastructure development in the last few years. Pune-based Venkateshwara Hatcheries, a leading poultry vaccine manufacturer is entering manufacturing human vaccines. Venkateshwara Hatcheries is investing about $40 million in phases. Biocon leverages its India cost-base together with its extensive expertise and technology platforms to offer competitive, high quality, custom manufacturing services to a global clientele. Its full set of manufacturing capabilities, include mammalian cell culture fermentation, microbial cell culture fermentation, synthetic chemistry, formulation development for solid dosage (tablets and capsules) for immediate and modified release, injectables (vials, cartridges, lyophilized and pre filled syringes) and a fill finish facility. "Inspected by the USFDA on more than one occasion, the facilities are internationally benchmarked making it partner of choice for companies seeking innovative solutions for their medication delivery needs," remarked Dr Gautam Das, COO, Syngene. Last year Biocon inaugurated a multi-product biologics facility in Bangalore. The facility is designed to manufacture a broad range of novel and biosimilar therapeutic products through large scale cell-culture fermentation for the treatment of cancer, auto-immune and metabolic diseases. "We are focusing on our contract manufacturing business and it is also the growth driver for Syngene," said Kiran Mazumdar Shaw, CMD, Biocon. Biocon had set up a multi-product biologics facility at Biocon Park, Bangalore. Biocon established Biocon Biopharmaceuticals Private Limited (BBPL) in collaboration with CIMAB, representing the Centre of Molecular Immunology, Cuba. The state-of-the-art cGMP compliant facility is designed to manufacture a broad range of novel and bio-similar therapeutic products through large scale cell-culture fermentation for the treatment of cancer, auto-immune and metabolic diseases. The facility is also designed to cater to contract manufacturing needs of international biopharmaceutical companies. The l.2 lakh-sft building spread over three floors comprises process, laboratory and technical support areas. The new facility represents a significant advancement in terms of technical sophistication over Biocon's existing facilities and comprises three distinct modules--cell culture module for monoclonal antibodies and other cell culture products; aseptic formulation and filling module for sterile products in vials, cartridges, lyophils and syringes; and quality control module. Wockhardt has a contract-manufacturing relationship with Amylin and many other leading pharmaceutical companies, such as Aventis and AstraZeneca. It has manufacturing plants in India and the UK, which are certified by the USFDA and the UK's MHRA. Bharat Biotech has state-of-the-art manufacturing plants meeting stringent standards laid down by internationally recognised institutions such as USFDA, UKMCA and WHO. And its production capabilities extend to vaccines and biotherapeutics. Bharat Biotech had set a precedent in this emerging area with the manufacture of HibTITER (Haemophilus Influenzae b Conjugate Vaccine) for Wyeth Lederle. This was the first time that a vaccine was moved out of the US for manufacturing in India. BBIL is also manufacturing a cancer therapeutic for US-based Agenix. Shantha Biotechnics also offers high quality contract manufacturing services well supported by its experience in QC, QA and R&D. It has state-of-the-art facility conforming to cGMP for manufacturing biopharmaceuticals and quality control facility to cater to the in-process and finished product testing. From the very beginning Shantha has invested in building manufacturing capabilities and infrastructure to meet the most stringent regulatory requirements for manufacturing of biologicals. Reliance Life Sciences (RLS) has started contract manufacturing and contract research of biopharmaceuticals. RLS currently offers a complete range of contract manufacturing and contract research services to address the products discovery and development needs of the customers in the biotechnology industry. Its contract manufacturing services ranges from bioassay development, process development, analytical testing to clinical lot and commercial batch manufacture. Asia is, no doubt a major center for manufacturing chemical-based pharmaceuticals. It is a favored destination for contract manufacturing. But the biopharma manufacturing is small. According to a recent report published by HighTech Business Decisions, "Biopharmaceutical Contract Manufacturing: Best Practices Pricing Study 2006", between 2002 and 2006, the size of the biopharmaceutical contract manufacturing market has doubled, reaching more than $2 billion in 2006.   Some of the major biotech manufacturing facilities in India Biocon Biocon had set up a multi-product biologics facility at Biocon Park in Bangalore. The state-of-the-art cGMP compliant facility is designed to manufacture a broad range of novel and biosimilar therapeutic products through large scale cell-culture fermentation for the treatment of cancer, auto-immune and metabolic diseases. The l,20,000-sft building spread over three floors comprises process, laboratory and technical support areas. The new facility represents a significant advancement in terms of technical sophistication over Biocon's existing facilities and comprises three distinct modules -- cell culture module for monoclonal antibodies and other cell culture products, aseptic formulation and filling module for sterile products in vials, cartridges, lyophils and syringes, and quality control module. Inspected by the USFDA on more than one occasion, the facilities are internationally benchmarked. Biological E Biological E has three manufacturing facilities in Azamabad, Hyderabad. The state-of-the-art facilities are designed to manufacture a broad range of products under each of its therapeutic segments like solid dosage forms, vaccines and sera, bulk actives, injectables, liquid orals in different locations which are WHO cGMP certified. The units have the production capacity of 2 lakh samples per day. Serum Institute of India Serum Institute of India is setting up a biotech Special Economic Zone (SEZ) at Pune with an investment of $265 million. About one billion doses of various vaccines are expected to be produced on an annual basis from this SEZ. Oncological products for the US and EU markets are also expected to be manufactured at the new facility. The premises has been pre-qualified by the WHO. Serum Institute develops the technology for the manufacture of polysialic acid and its derivatives to the US Food and Drug Administration standards. Bharat Biotech Bharat Biotech has state-of-the-art manufacturing plants meeting stringent standards laid down by internationally recognized institutions such as the USFDA, UKMCA and WHO. Its production capabilities include vaccines and biotherapeutics. Bharat Biotech had set a precedent in this emerging area with the manufacture of HibTITER (Haemophilus Influenzae b Conjugate Vaccine) for Wyeth Lederle Ltd. Panacea Biotec The new Greenfield construction Vaccine Formulation Plant (VFP) has been introduced in Baddi, Himachal Pradesh. The plant has been commissioned with several filling lines for bacterial and viral vaccines complying with WHO, cGMP norms for liquid vaccines in pre-filled syringes, liquid and lyophilized vaccines in vials. The total production capacity of this facility is one billion doses per annum. The three-story production block is spread over approximately 30,140 sft construction area at each floor. The plant also has a two-story block of warehouse-cum-cold storage facility admeasuring approximately 26,910 sft on each floor. It also has a 50,000-sft vaccines formulation facility in New Delhi, a WHO cGMP approved facility with WHO pre-qualification for oral polio and recombinant Hepatitis B vaccines. With a built-up area of more than 50,000 sft, it has three vial filling lines -- two lines dedicated to oral polio vaccines both trivalent and monovalent and one line dedicated to Hepatitis B and combination vaccines. Provision has also been made for a separate filling line for pre-filled injection devices. Also any injectable preparation can be filled in vials. The injectable vaccine facility is also expected to be WHO pre-qualified for combination vaccines during the current fiscal. Wockhardt Ltd Wockhardt has set up a global-scale biopharmaceuticals manufacturing powerhouse, the Wockhardt Biotech Park in Aurangabad. This state-of-the-art complex comprises six dedicated, manufacturing facilities, and is designed according to the USFDA and EMEA standards. It has eleven world-class manufacturing plants in India, the UK and Ireland. The new SEZ is spread over 107 hectares of land. The SEZ house manufacturing facilities for Active Pharmaceutical Ingredients (APIs), biopharmaceuticals, and a research and development center. Shantha Biotechnics Shantha Biotechnics has a facility at Medchal near Hyderabad where it manufactures products like Shanvac-B (Hepatitis B vaccine), Shanferon (Interferon Alpha-2b) and also Shankinase (Streptokinase drug). It has state-of-the-art facility conforming to cGMP for manufacturing biopharmaceuticals and the quality control facility to cater to the in-process and finished product testing. Indian Immunologicals Ltd The total area of the Indian Immunologicals Ltd (IIL) complex at Hyderabad is 213 acres. The veterinary vaccine plant is one of the largest plants in the world with the state-of-the-art technology, WHO-GMP and ISO-9002 certified. The modern plant at Hyderabad has an installed production capacity of 25 million quadrivalent doses of FMD vaccine, which is the largest in Asia and the facility at Ooty manufactures rabies vaccine. Jubilant Organosys Jubilant Organosys has state-of-the-art pilot and commercial scale multi-purpose pharmaceutical manufacturing plants conforming to cGMP guidelines and approved by various regulatory authorities such as the USFDA and TGA. It has 6 large-scale commercial multipurpose plants at Gajraula (100 km from Delhi) and 4 at Nanjangud (near Mysore in Karnataka), which operate on DCS systems. The Nanjangud facility has USFDA approval. Both these facilities put together have 135 reactors ranging from 1 KL to 12 KL. Total reactor volume is 600 KL. Jahanara Parveen with Shalini Gupta in New Delhi   ]]> <![CDATA[25 years of Applied Biosystems' Model 470A Protein Sequencer]]> https://biospectrumindia.com/news/95/2843/25-years-of-applied-biosystems-model-470a-protein-sequencer.html https://biospectrumindia.com/news/95/2843/25-years-of-applied-biosystems-model-470a-protein-sequencer.html Fri, 05 Oct 2007 12:54:00 +0530 New Page 1 25 years of Applied Biosystems' Model 470A Protein Sequencer A 470A Protein Sequencer at Chiron Corporation in Emeryville, California Applied Biosystems is celebrating the 25th year of introducing its first product-the protein sequencing machine that revolutionized the life sciences research. Applied Biosystems released its first commercial product, the Model 470A Protein Sequencer in August 1982 for identifying the amino acid sequence within a purified protein for which the company reported the first-time revenue of $402,000. Using a Model 470A Protein Sequencer, researchers can, for example, determine the sequence of one of the coat proteins of a disease-causing virus. Today the company manufactures and markets more than 25 different automated instruments, over 400 liquid chromatography columns and components, and approximately 320 chemicals, biochemicals, and consumables for the synthesis, purification, and analysis of DNA, proteins, and other biological molecules and the company posts sales of over $132 million and employs almost 1,000 workers in eight countries. Protein sequencing provides a means of obtaining information about the primary structure of polypeptides and protein sequencing technology is critical to mapping the human genome and bringing humanity closer to understanding the molecular mechanisms that drive life itself. Protein sequencing has remained central to modern molecular research. Rather than sequencing the entire proteins today's requirements are generally more to supplement and compliment other approaches. For instance, protein sequence information is a prerequisite for DNA cloning, providing the information for making oligonucleotide probes and polymerase chain reaction chain primers. It allows the synthesis of peptides for antibody production, provides identification of proteins of interest and helps in the characterization of recombinant products. A major use of protein sequencing is in the study of post-translational modification. 25 years later the general methodology has changed relatively little since the introduction of the first protein sequencer. However, the use of automated equipment to perform multiple cycles have greatly improved the efficacy of sequencing. Automated protein sequencing as a recent advance has been a major significance in the field of biotechnology. Optimization has allowed the determination of extended sequences of very low abundance proteins. Much effort in recent years has been devoted to improving the sensitivity of protein sequencers by using new, highly sensitive methods for identifying amino acids. A large number for upgraded, automated and sensitive DNA sequencing machines continue to enter the market at a much cheaper cost. With the advances in protein sequencing technology the vast amount of protein sequence data now available, together with accumulating experimental knowledge of protein function, enables modeling of protein sequence and function evolution to model evolutionary sequenceâ€“function relationships on a large scale. It is important to mention that the results delivered so far are mostly descriptive and give the essential basis for further investigations which will need to be carried out in order to make the best use of this linear sequence of information. Data from protein sequencing experiments have provided scientists with a wealth of information establishing the basis for the investigation of cellular processes. Towards the end of their research and development efforts, pharmaceutical companies seek to deliver safe and efficient molecules. With the tremendous technological developments happening in protein and DNA sequencing, pharmacogenomic approaches will profit from the availability of the human protein sequence providing clues to describe genetic networks and may ultimately initiate new ways of developing compounds. The availability of the human protein sequence together with the pharmacogenomic and pharmacogenetic approaches should contribute to a better selection together with a faster development of safer and more effective drugs. The availability of the human protein sequence shall contribute to reach this goal.   ]]> <![CDATA[Unraveling of complete human genome sequence: hope or hype?]]> https://biospectrumindia.com/news/95/8116/unraveling-of-complete-human-genome-sequence-hope-or-hype.html https://biospectrumindia.com/news/95/8116/unraveling-of-complete-human-genome-sequence-hope-or-hype.html Fri, 05 Oct 2007 12:43:00 +0530 New Page 1 Unraveling of complete human genome sequence: hope or hype? Dr Craig Venter The deciphering of genomes will be invaluable in revealing the detailed mechanism of the immune response and would provide new targets for drugs, as well as the basis for designing new vaccines. Gene discoveries and understanding the human genome have resulted in improved understanding of the genetic basis of disease and created new opportunities for diagnosis, treatment, and prevention of disease. Since the completion of the Human Genome Project in 2003, research efforts have been aimed at analyzing the functions of various sequences in the genome, using both experimental and computational strategies. Biologist J Craig Venter is back with the decoding of his own genome. He and his team recently announced that they had finished the first mapping of a full, or diploid, genome, made up of DNA inherited from both parents. This new genome sequence is considered by many scientists to be of much higher quality and contains much more detail than the genome completed by the Human Genome Project consortium. Published in the online open access journal PloS Biology, the 2.8 billion contiguous bits of genetic code will also hasten advances in preventive medicine. The findings overturn what had in a few short years become genetic gospel: that all human beings are, genetically 99.9 identical. This set of 23 paired chromosomes, made up of six billion chemical units in total, is the first full human genome ever decoded for an individual. Dr Venter has spent the last five years and an extra $10 million of his institute's money in improving the draft genome he prepared at Celera. That genome was based mostly on his own DNA, and the new diploid version is entirely so. Like James Watson, the co-discoverer of DNA, whose genome is also being decoded, Dr Venter has made individual DNA sequences public to advance knowledge and hasten the era of personalized genomic medicine. Dr Venter has also been in the news recently for seeking to patent the world's first man-made species referred to as Mycoplasma laboratorium, a synthetic microbe that could be used to produce fuel. It is part of an effort to create designer bugs to manufacture hydrogen and biofuels, as well as absorb carbon dioxide and other harmful greenhouse gases. In 1998, Dr Venter founded Celera Genomics to sequence the human genome using the whole genome shotgun technique, new mathematical algorithms, and new automated DNA sequencing machines. The successful completion of this research culminated with the publication of the human genome in February 2001 in Science. In addition to the human genome, Dr Venter and his team at Celera sequenced the fruit fly, mouse, and rat genomes. A less complete version has been reported in 2001 by the Human Genome Project, a consortium of academic centers supported largely by the National Institutes of Health and the Wellcome Trust, a medical philanthropy in London. The first two maps of the human genome were based on a patchwork of DNA from several donors. Both versions were also half maps, decoding only one set of the 23 chromosomes on the assumption that the two sets would hardly differ. Both sides have achieved remarkable success with their chosen approaches. Celera's whole genome shotgun approach has proved faster, but both with its fruit fly and the human genome, Celera has made use of data obtained by the consortium's clone-by-clone approach. If Celera's version of the human genome proves as good as its fruit fly genome, scientists may judge it to have chosen the better path. Nonetheless, both sides can fairly claim credit for the final result. The two groups even differ on the size of the gene-coding part of the genome. Celera says it is 3.12 billion letters of DNA; the public consortium claims that it is 3.15 billion units, a letter difference of 30 million. Neither side can yet describe the genome's full size or determine the number of human genes. Both versions of the human genome meet the important goal of allowing scientists to search them for desired genes, the genetic instructions encoded in the DNA. Such speedy gene sequencing would represent a technology breakthrough for medical research. With this type of knowledge now in hand and a better understanding, the human genome is expected to revolutionize the practice of medicine where genome sequence information becomes a critical reference to assist with health-related decisions. Biologists expect to develop an array of diagnostics and treatments based on it and tailor it to individual patients, some of which will exploit the body's own mechanisms of self-repair. Genes can give useful information about increased risk for disease, but in most cases they do not determine the actual cause of the disease, or the actual incidence of somebody getting it. Most biology will come from the complex interactions from all the proteins and cells working with environmental factors, not driven directly by the genetic code. But by knowing before a disease develops what one is susceptible to, one can try to prevent it, thus lowering the healthcare costs. Preventive medicine is expected to be the future. For example, if a disease is detected early, because a person knew he had a genetic risk and was being frequently examined, the surgery would be relatively inexpensive and average survival is far greater than 10 years. The most extreme suggested use for the human genome data is editing the DNA inheritance bequeathed from one generation to the next. This involves identifying an abnormal gene and then correcting it in the cells, which are used to pass genetic information to offspring - eggs and sperm. Therefore no subsequent generation would then be afflicted by their ancestors' gene defect. The era of personal genomics is yet to begin. Next generation genomics technologies are breathing new life into the market, and are expected to contribute to the robust growth of the US genomics market and other continents between 2005 and 2012, according to several industry experts. Top US industry participants are successfully developing specific applications for each evolutionary stage of the genomics research process, and are likely to maintain revenue streams, while strategically positioning themselves to penetrate the future markets for clinical applications of genomic technologies. New analysis from Frost & Sullivan, strategic analysis of the US genomics markets, reveals that revenues in this market totaled $1.85 billion in 2006, and is likely to reach $3.69 billion in 2012. That doubling in revenue will occur along with a huge increase in the amount of DNA sequence produced per dollar spent. It is also expected that sequencing costs will drop by three times perhaps in the next five years from now. The cost of sequencing DNA has been dropping by half every two years. The market for DNA-sequencing machines and chemicals is expected to increase between 4 percent and 5 percent per year. Scientists are doing most of the DNA sequencing for their own research purposes today. But at some point in the next 5-10 years, the desire to learn one's own personal genome sequences will become the biggest source of demand for DNA sequencing services. Also demand will grow for surreptitious DNA sequencing services so that people can learn the DNA sequences of prospective employees, celebrities, and business competitors. Science is expected to turn up all sorts of practical uses of DNA sequence information and the genetic privacy will become very hard to protect. While DNA patents create a wide variety of possible benefits and harms for science and technology, the evidence at this point in time supports the conclusion that it will probably promote rather than hamper scientific discovery and innovation. However, since DNA patenting is a relatively recent phenomena and the biotechnology industry is in its infancy, efforts would be to gather evidence about the effects of DNA patenting on scientific innovation and discovery as well the economic, social, and legal conditions relating to intellectual property in biotechnology. The markets, the courts, researchers, and patent offices should be given a chance to settle issues related to innovation and discovery, before we seek legislative remedies are sought, since new laws proposed at this point would lack adequate foresight and could do more harm than good. However, one should be open to new laws or regulations on DNA patents if they are required to in order to deal with some of the biases and limitations of the free market. It will be a while before one will be able to garner a full understanding of how genes influence our lives. Within five years, faster and cheaper sequencing techniques could produce complete genomes for 10,000 people, laying the foundation for an era of individualized genomics. Quick and affordable decoding of many people's DNA will accelerate the effort to understand the links between genes and diseases and people may one day plug their genetic information into Internet search engines to download the latest information on their genetic strengths and susceptibilities. It is going to be the best way to get information about lifestyle choices. Biology has progressed from near total ignorance of the hereditary material to possession of the entire human genome within 50 years and is testament to a hectic pace of discovery. There is little doubt that the revelation of the human genome will benefit healthcare in the short and long term. Jahanara Parveen   ]]> <![CDATA[Celebrating product developments]]> https://biospectrumindia.com/news/95/5950/celebrating-product-developments.html https://biospectrumindia.com/news/95/5950/celebrating-product-developments.html Fri, 05 Oct 2007 12:26:00 +0530 New Page 1 Celebrating product developments With each passing day the Indian biotech industry is getting all the more exciting. In fact, the last two months alone have witnessed several product launches. India's leading biotech company, Serum Institute of India has launched Haemophilus influenza type b conjugate vaccine-HibPRO-in India. Hyderbad-based Bharat Biotech International (BBIL) followed suit with its version, Haemophilus Influenza Type b (Hib)-BioHib-vaccine. It also introduced Comvac 4-HB, a tetravalent combination vaccine. These vaccines are not only affordable alternatives to the existing vaccines, but have also been developed indigenously. Though this is just an indicator of the things to come, what is more important is that vaccine manufacturers in India are working overtime to develop and launch several vaccines like pentavalent vaccines, injectable polio vaccines, and rotavirus vaccines. Another major development has been the launch of macro diagnostic chips by Bangalore-based Xcyton Diagnostics. Xcyton, no doubt, has taken the lead in pioneering the development of DNA macro-chips in the country. This chip, according to the scientists involved in the development, will allow simultaneous investigation of multiple infections instead of sequentially diagnosing infections and is a platform combining the nucleic acid amplification and genomics-based DNA macro-array. A very important feature of this development is that this platform has been the outcome of public-private institution partnership. The company developed a Vision chip in collaboration with institutes like AIIMS, Sankara Netralaya, LV Prasad Eye Institute, and Center for Cellular and Molecular Biology (CCMB). Its HPV chip was developed in association with Rajiv Gandhi Center for Biotechnology (RGCB), ACTREC, Kidwai Memorial Institute of Oncology, and CCMB. The product was under the aegis of CSIR initiated New Millennium Indian Technology Leadership Initiative (NMITLI). While the products being developed by Indian companies are on the rise, so is the commitment of global companies in India. Again this month one saw some major announcements being made by the top executives of global majors. PerkinElmer announced that it is strengthening its India presence and Waters Corporation has inked a unique pact. There is an underlying message besides these companies seeing India as a high growth market. The message is to bring out innovative products. For instance, PerkinElmer has announced a project with the Indian government (Indian Council for Medical Research) for genetic screening. Waters Corporation has tied up with Lambda Therapeutic Research, an Indian CRO company to understand the challenges of the CRO companies and come up with solutions like they did in getting their market leading Ultra Performance Liquid Chromatography (UPLC) technology a few years back. Recently, GE Healthcare, a healthcare and life sciences solutions unit of GE, organized a summit to champion the cause of "early health" in India. It discussed the medical and economic benefits of evolving medicine and patient care from treating symptomatic "late-stage" disease to a focus on early pre-symptomatic detection and intervention. It is a revelation that GE has developed several products and is collaborating with many organizations to bring about a paradigm shift in the way healthcare is managed in India. All these developments call for celebrations of scientific development and awareness.   <sureshn@cybermedia.co.in>   ]]> <![CDATA[Innovate India 2007]]> https://biospectrumindia.com/news/95/2424/innovate-india-2007.html https://biospectrumindia.com/news/95/2424/innovate-india-2007.html Fri, 05 Oct 2007 12:19:00 +0530 New Page 1 Innovate India 2007 The conference aims to bring the knowledge creator and the knowledge seeker on a common platform to inspire technology management and new product development. Innovation is closely linked with increased productivity and economic growth. However, in order to build a strong innovative environment in the country, there is a need to gain a better understanding of the role of technology and innovation. This is possible only when exchange of expertise is allowed to flow freely across borders. A growing number of business gurus are recognizing that innovation realized is the revenue generated and innovation must be embedded into the very fabric of institutions. It is to address this that the National Research Development Cooperation (NRDC) is planning to organize Innovate India, a conference on "Leveraging innovations and inventions" on October 15-16, 2007 at the India Habitat Centre, New Delhi. The conference aims to bring the knowledge creator and the knowledge seeker on a common platform to inspire technology management and new product development. It will further address the role of people, how they spread the use of management practices, to improve goods and services and analyse how human skills are developed and deployed in new markets or business models. The two-day conference will see researchers and professors from around 244 Indian universities and national/public research institutes present their thought-provoking ideas and brainstorm with each ot her. Budding scientists, research scholars, young inventors and academicians will exchange their ideas and explore emerging directions both in innovation and R&D management. Conference objectives The conference aims at inducing, targeting and stimulating the innovation and technology development in India and provide guidance and advice to individuals and companies involved in R&D. It will also help in networking with research institutions and entrepreneurs in the field of inventions and technology transfer and arrange technology transfer through buyer-seller meet. Some of the key thrust areas during the conference will be: nurturing inventions and innovations; role of universities and R&D; organization; IP assets in knowledge economy; key actors in innovation cycle; strategic innovations driving business In a nutshell, the event hopes to provide a better understanding of the innovation cycle to improve upon the national invention system specially in three areas of particular relevance, i.e. the linkages to regional actors, regional institutions and the importance of regional markets for innovation activity. Nurturing new ideas The event is organized by NRDC, which aims to capture, protect, develop, commercialize and nurture the invention and innovations and put these into the marketplace for the benefit of individuals, R&D institutions, universities under its Invention Promotion Programme.   ISCGT India 2007 The two-day conference will feature noted speakers representing areas including gene therapy and stem cell therapeutics A conference on cell and gene therapy will be organized by the International Society for Cell and Gene Therapy for Cancer, (ISCGT), hosted by Actis Biologics. The conference, which will be held in Mumbai from November 16-18, 2007, was previously held in the US, Japan, China, Singapore, Germany and UK. DBT has extended its support to this conference. India has reaped rich dividends for more than a decade of biological and biotech research and development. Laboratory-developed technologies have been field proven. Biotechnology research has a new direction with innovations being patented and technologies being transferred to, and shared with, industry. India's biotech firms are emerging as major, global healthcare-market players, with the expertise and means to produce new and generic drugs and vaccines for significantly less than the giant Western firms. Dr Farzin Farzaneh, president of ISCGT, said the conference will have noted speakers representing areas including oncolytic viral therapy, immunotherapy, gene therapy, clinical trials and stem cell therapeutics. In addition, this will represent a rare and intriguing opportunity to hear top international and Indian researchers from academia, the emerging Indian biotech industry, providing first hand information on the extensive clinical trials being conducted in India on oncolytic virotherapy, gene therapy, and cellular therapy for cancer, and to interact with counterparts across the world in these fields. Sanjeev Saxena, founder and CEO of Actis Biologics, said the need to support this conference will help working with leading scientists throughout the world and entrepreneurs to set up life science ventures in Asia. The conference will have close to 40 speakers from nine countries and close to 500 scientists, researchers, academia, clinicians, research fellows and students from India and abroad are expected to attend. Renowned scientists such as Dr Nori Kasahara, David Geffen School of Medicine, Dr Savio Woo, Mount Sinai School of Medicine, Dr Kumaravel Somasunderam. IISc, Dr Girish Vyas, UCSF, Dr R Ramesh, MD Anderson Cancer Centre, Dr Rita Mulherkar, ACTREC, Dr Albert Deisseroth, Sidney Kimmel Cancer Centre, Dr David Curiel, University of Alabama will deliver lectures, hold Q&A sessions and conduct workshops. Posters and abstracts sessions have been planned to promote young investigators and the ISCGT Innovation Awards will be instituted at this conference to reward those scientists, researchers and clinicians who have made noteworthy contribution in their respective fields. ISCGT is a non-profit UK-based association with affiliations in America, Japan and Europe. ISCGT's principal goal is to foster camaraderie and collaboration between scientists and clinicians, around the globe, in their quest for cell and gene therapy for cancer treatment. ]]> <![CDATA["The growth of analytical business in India is more than 15 percent annually"]]> https://biospectrumindia.com/news/95/1479/the-growth-of-analytical-business-in-india-is-more-than-15-percent-annually.html https://biospectrumindia.com/news/95/1479/the-growth-of-analytical-business-in-india-is-more-than-15-percent-annually.html Fri, 05 Oct 2007 12:12:00 +0530 New Page 1 "The growth of analytical business in India is more than 15 percent annually" -Dr G Ramakrishnan, president, IAIA and managing director, Thermo Electron LLS India When was the Indian Analytical Instruments Association (IAIA) set up and what is its mandate? The IAIA was set up in 1996 by a few leading members of the analytical instruments industry in India with an idea of creating an organization which is a non-profit body to take care of the general interests of the members of the organization in taking up some of the issues related to doing business with the government bodies such as ernest money deposit, bank guarantee and other stringent formalities. The organization also wants to bring up with the government the issues regarding the customs duty of the analytical instruments. What are some of the key things that IAIA is doing to promote the industry? One of the main activities has been bringing the analytical instrument exhibition to various cities in India and also a scientific conference on analytical instruments. The initial few exhibitions and conference were held in Mumbai and later on for the last three exhibitions and conference IAIA collaborated with Messe Munchen to bring in the internationally reputed Analytica exhibition in the name of analytica Anacon. This year the fourth such trade show and scientific conference will be held from October 31-November 2, 2007 at the Hitex exhibition center in Hyderabad. What is the current size of the analytical instruments business in India and worldwide? How do you see the analytics instruments growing in India? A rough estimate of the global figure would be $20 billion worldwide and my estimate of the Indian market can be close to $1 billion. The point to note is that the growth of the analytical business in India is more than 15 percent annually. Several global companies are strengthening their businesses in India and how does IAIA support them? It is true that several companies are expanding their activities in India, especially establishing direct operations and expanding their existing direct operations. The companies that do not have any representation in India are always on the lookout for the right partners and IAIA will be happy to introduce to such companies to the members of IAIA including providing them the contact details. Global companies are also welcome to take part in the activities of IAIA such as the trade shows and scientific conferences. What are your top priorities in making India a hub for analytical instruments in Asia? IAIA along with Messe Munchen has been bringing the major trade show and symposia to India and this is heavily advertised in the neighboring countries and we are expecting some of their scientists and chemists to visit these trade shows in India. I understand that some of our member companies are engaging in providing the regional support for maintenance of instruments to neighboring countries and also the application and training support. The association has not yet put any special effort in making India as a hub, but it is worth looking into how this can be done by knowing the expectations of the neighboring countries. How many members does IAIA currently have and what are its future plans? IAIA has more than 60 members and we are looking forward to enrolling more members during the forthcoming analytica Anacon India 2007 in Hyderabad. Can you please throw more light on the forthcoming event? We are placing major focus on the Hyderabad analytica Anacon India 2007 event. More than 2,000 sqm space has been sold out and we have all the major instruments companies, both foreign and Indian, taking part in the same. We expect that the exhibition will be attended by more than 3000 important visitors in the three-day trade show. We are also having a three-day scientific conference, around 20 lectures by leading personalities from abroad, from instrument manufacturers and from leading universities. The registration for the trade show and the conference is free and we are adding a great value to all our valued customers. We are also planning to recognize and confer Life Time Achievement award for 10 personalities from the analytical industry in India, who have helped in serving the industry in more than one way for several decades. Jahanara Parveen   ]]> <![CDATA[There is not too much of difference between India and the US market]]> https://biospectrumindia.com/news/95/2411/there-is-not-too-much-of-difference-between-india-and-the-us-market.html https://biospectrumindia.com/news/95/2411/there-is-not-too-much-of-difference-between-india-and-the-us-market.html Fri, 05 Oct 2007 11:54:00 +0530 New Page 1 There is not too much of difference between India and the US market PerkinElmer India, a wholly owned subsidiary of US-based $1.55 billion PerkinElmer, a global technology leader in health sciences and photonics, is in the process of expanding its base in India to help scientists advance the pace and precision of research and testing in a wide range of markets. The company has tied up with the Indian Council for Medical Research (ICMR), whereby research on genetic screening of newborns will be conducted at five centers spanning Kolkata, Chennai, Delhi, Mumbai and Hyderabad. Dr Lapo Paladini, vice president, global sales and marketing and president, Asia for PerkinElmer life and analytical sciences and Jai Shankar, president, PerkinElmer India, share the company's India specific plans with BioSpectrum. Excerpts of the interview: Dr Lapo Paladini Jai Shankar How do you see the difference between the Indian and the US market? There is not too much of difference between India and the US market. And the reason is that India is not an emerging country. There are a lot of well-established multinational companies in this country. Clearly we know that there is a factor of labor cost that has encouraged investment from manufacturing companies in the past, shifting capabilities from western companies into India. So you may find little difference of applications and customer needs, but the expectations of the customer, which for us is an important factor, is exactly the same. Our standards in terms of quality of service and products is exactly the same. What is the strategy behind operations in the Indian market? We wanted to make massive investments here to take advantage of this market's potential. And to do that we distinguish often between an opportunistic approach, i.e. a one value selected approach so that we enjoy the revenue as they come or you play personal in that market place and you have to learn from and about the market that ways. Considering that, here you have an easy access to very highly skilled people for all types of profiles that we need within our business and operations. So we need to bring in expertise and practice from outside, not people. Our customers here can have access to world class practices like in the western countries. We have set up India as the next supplier of best practice. The marketing strategy for us is very simple. First of all we want to list all the marketing segments that we want to address with our products. One of the major competitive advantages that we have versus our competitors is that none of them is a competitor on the lines that we have because only a few of them have the same range of portfolio that we have. This provides us an opportunity of knowing different market segments and sometimes also being a little selective in segments that we want to focus on. Also we want to know what the requirements are to succeed with those customers, to serve them in a way that is according to their expectations. We elaborate on the customer's requirements making sure that we can offer both in terms of technical and application support. We want to be recognized as a solution provider rather than an instrument seller. We also identify what is the best channel to deliver customer's expectations versus our commitment. We are planning to develop all the channels that operate in the West such as the E-channel, giving customers fast access to the consumables business and planning to have a huge coverage across the entire country leveraging the nine offices that we have. How do you differentiate yourself from your competitors? Competitiveness is one of the areas why this company is stronger than the others. It is difficult to make a comparison because it may range by application, by geography. In a country, there are different competitive positions, north versus south for instance. Our objective to be competitive goes around three main concepts: Products: We try to select products from the premium suppliers, the top three major players in any market we play. For a company, with our brand reputation this requires us to be very conscious to be innovative enough to stay ahead in the game. People: This is one of the reasons we decided to take ownership of an important country like India, shifting from a more opportunistic approach to a more planning and management kind of approach. Then you get in control of your people. Then you can export here to the benefit of the local market and then as a competitor have an advantage versus other competitors having the best practices and values that characterize our company. Processes: Processes are important because they translate into an easier way of doing business with us. Any country has its own challenges like logistics, distribution or geography. This can be solved by knowing the local situation, how we can serve those customers and meet their expectations and deliver our commitment. So a combination of high quality products, world class people and processes is what makes us competitive in the marketplace. What is the USP of PerkinElmer? One of the stark features of our organization is that we have a wide portfolio that cuts across various segments including pharmaceuticals, polymer and packaging. We have products across a wide range. If you look at other organizations and the products that they have, you can see that they are not planned out. So, one of the key strengths that we see is a product that cuts across 30 segments. PerkinElmer India has entered into a project with the Indian government for genetic screening. Kindly elaborate on this. The incidence of genetic disorders in India is not fully tabulated as yet. We have the database of the incidence and occurrence of genetic disorders. So our first endeavor is to have statistical data within India as well. We made a presentation to the government. We talked to the ICMR with whom we have a tie-up whereby in the next two years we will get 1 lakh babies tested in terms of incidence of occurrence of various genetic disorders. With this, we will present a white paper to the government to institutionalize genetic screening in India. Most of the countries have mandatory screening processes and in India we still have to work on it. What are the other plans for India since the operations were started recently? There is a huge amount of potential here. We have opportunities in each of the segments that we have. With the proliferation of drug research and CRO companies, we are going to see further growth for our company. We are executing plans for our genetic screening business, which is again a huge opportunity for us to tap. Shalini Gupta   ]]> <![CDATA["We believe in doing well by doing good"]]> https://biospectrumindia.com/news/95/3659/we-believe-in-doing-well-by-doing-good.html https://biospectrumindia.com/news/95/3659/we-believe-in-doing-well-by-doing-good.html Fri, 05 Oct 2007 11:45:00 +0530 New Page 1 "We believe in doing well by doing good" -Gregory L Summe, chairman and CEO, PerkinElmer PerkinElmer India recently unveiled its latest generation of products as part of its expansion plan for the fast growing Indian life sciences and instrumentation market. In an exclusive interview with BioSpectrum, Gregory L Summe, chairman and CEO, PerkinElmer, who was recently in India, highlighted the company's India specific business plans. Excerpts: What is the contribution of the Asia Pacific market to the global sales of PerkinElmer? Asia Pacific makes for about 20 percent of our revenue and about 40 percent of our people are based in the Asia Pacific region. We have more of our manufacturing activities over here. The percentage of people will grow because we are investing ahead of the demand, and this area is growing faster than the rest of the world. So it is extremely important for us to continue our investments here. How has the growth been in the Asia Pacific region? Asia Pacific has been growing double digit for us and we expect this trend to continue. It has a higher growth rate than Europe or the Americas and so it is climbing as a percent. India has been a strong perfomer within the Asia Pacific region, more than 20 percent a year for us. How do you look at India as a market? We are looking at India as a developing marketplace. India is a growing resource, a business offsite. We have been in the market for about 25 years and we continue to step up our investments. We originally started as a group of distributors and then we had a joint venture structure. We now have a wholly owned subsidiary and we have invested millions of dollars. That was from a point of view to move faster and quicker. Today we have nine major offices in India. What are your major businesses in India? Today we are looking at three major businesses in India. One is environmental and health sciences that includes air and water, food safety, quality, biofuels and pharma QA QC. The second one is our life sciences business, which is a tool of discovery. This is helping identify targets in evaluating compounds against cells, like for example biochemical screening. The third is genetic screening and we are the world's leading provider of testing for newborns for inborn errors of metabolism How successful have you been in tapping these three areas in India? I think these are still early days. In all cases these markets are just at the beginning because the economic growth here is phenomenal and is continuously growing with an equal measurement of growth in terms of analytical scientists. The pharma industry is continuing to develop and become more sophisticated. Twenty percent of the world's babies are born in India, but there is almost no genetic screening as compared to the US where there is 100 percent screening on 29 conditions on every baby. So we have some early efforts with public and private people towards this end. I think these markets will continue to grow owing to globalization and industrialization. India is industrializing and this is being done through globalization. The case in point is the development of Indian multinationals that are reaching out and establishing themselves in the world market. We are in such early days. In a decade, this will continue to grow. PerkinElmer acquired the remaining minority interest in PerkinElmer India making the Indian arm a wholly owned subsidiary. What was the strategy behind it? I think it is about speeding capability. If you have to be successful in the Indian market, you have to be an Indian company. This means knowing the country's culture and customs so that you're quick to respond to the customer's needs and develop exactly what they need. Otherwise, you are just an exporter, a visitor to the market and we don't want to be a visitor to the market. We want to be a part of the market . You have said "our products will help Indians improve their quality of life". Kindly elaborate. Absolutely, and we are very proud of that. It's a mission for all our employees. It is not just that point. We have said in over a thousand countries including India and Australia, that these are the conditions that you pick up in the UK and treat them with medicines and diet and if you don't they resolve in severe handicaps. That's an example I think of the quality of life. We believe in doing well by doing good. They go hand in hand. It also creates demand for the product. If you are delivering clear benefits to the society, you can have sustainable demand in the market. So, it is rewarding for people to work. Are you looking at any partnerships? We are certainly in discussions with people to partner and develop valu-end of the instrument market. And we have also got some partners on the business processing side. The company went on a buying spree in 2006 and acquired six companies? Are you looking forward to any more acquisitions? We continue to be active in the acquisition marketplace. We have a robust pipeline of deals and we will continue to do that. What we are looking for is specialty companies with high growth rate with technology that fits across our various business lines. What are the new markets you're looking at? I think India, Eastern Europe and China are growing markets that we are looking at. Shalini Gupta   ]]> <![CDATA["Keen understanding, innovation and business impact is our key strategy"]]> https://biospectrumindia.com/news/95/6044/keen-understanding-innovation-and-business-impact-is-our-key-strategy.html https://biospectrumindia.com/news/95/6044/keen-understanding-innovation-and-business-impact-is-our-key-strategy.html Thu, 04 Oct 2007 14:26:00 +0530 New Page 1 "Keen understanding, innovation and business impact is our key strategy" -Art Caputo, president, Waters Division, Waters Corp. and Dr Rohit Khanna, vice president, worldwide marketing, Waters Corp. In an exclusive interview to BioSpectrum, Waters' top global executives share the company's plans and expectations from its India operations. KV Venugopalan, president, Waters India, Art Caputo, president, Waters Division, and Dr AK Dasgupta, director, Lambda Therapeutics Research, announce the pact. What is Waters Corporation's strategy as a global corporation? Our global strategy can be summed up in five words-keen understanding, innovation, and business impact. Our focus is on understanding the customer's challenges and creating advantages for them by delivering practical and sustainable scientific innovation and help customers make faster discoveries, optimize lab operations, and ensure regulatory compliance. You have announced an agreement with Lambda. What are your expectations? We were here to set up a collaboration with Lambda Therapeutic Research. Lambda Therapeutic Research is an internationally known expert in clinical research. And the agreement will enable Lambda to meet its international business goals by fulfilling its needs for innovative laboratory equipment. Additionally, Waters will share its keen understanding of scientific and laboratory management through dedicated training opportunities. This is not a commercial agreement. Partnering with such leaders would make us know the future challenges, meet those challenges and dominate the market. This is part of our globalization process. A case in point is our Ultra Performance Liquid Chromatography (UPLC) system. This technology was introduced in March 2004 and was the outcome of a similar agreement with a customer. UPLC technology utilizes a packing material with small, uniform diameter particles and a specialized instrument (ACQUITY) to accommodate the increased pressure and narrow chromatographic bands that are generated by these small particles. By using the ACQUITY UPLC, researchers and analysts are able to achieve more comprehensive chemical separations and faster analysis times in comparison with many analyses performed by HPLC. During 2005 and 2006, Waters experienced growth in the instrument systems product line primarily from the sales of the ACQUITY UPLC. We are the clear leaders. We brought UPLC three years back and till now no one has come up with the technology to build UPLC systems. We now expect to come up innovative products now in the CRO space and take the lead. Is this the first such agreement in India? This is the first such collaboration from a company in India. We would be looking at having more such collaborations. What are the focus areas of Waters Division? If we look at what is happening in technology, we focus very much in the areas in which our customer base has the highest degree of challenge. So separation, mass-spectrometry, and informatics-all these are key areas of challenge. Our approach is to stay focused in the areas in which the customers are facing difficulties, for instance informatics. UPLC is still at infancy but tremendous developments are taking place in these areas. UPLC is the most ideal technology and growing very quickly. It is an ideal tool for method development. HDMS is again a new technology, which has been launched this year. We introduced a new Tandem Quadrupole device (TQD) and a new hybrid quadrupole-time of flight technology system, the Synapt HDMS. The Synapt HDMS system integrates ion mobility technology within a Q-Tof geometry instrument configuration and allows researchers to glean molecular shape information, a novel capability for a mass spectrometry instrument. The introduction of these new products has augmented the recent growth of the MS instrument systems. We continue to drive the old technologies while putting more effort towards developing new technologies. Innovation and performance is what have been driving us. What will your India technology center cater to? India's business for Waters is one of the fastest growing. In 1997, we made a decision to form a company which was a $2-3.5million and now in 2007, it has grown to a $60-million company. We have inaugurated a technology center in Bangalore for which we have made large investments. It has been set up for multiple purposes-to provide support to the customers and train the customers and the staff as well. We will also bring experts from outside Waters. At present it is a 27,000-sft facility and we have made substantial investment in the center. The investment on the equipment alone is Rs 6 crore and much more has been spent on the manpower and infrastructure. We see India as a very important market to make good investment and India will represent one of the important opportunities. How do you operate globally? We have operation in all corners of the globe and we operate directly. In Asia, we have direct operations in India, China, Singapore, Japan, Australia and Taiwan but in places like Indonesia, Philippines and Thailand, we operate through dealers. Customer support and customer success is most critical. Most companies in our industry invest a lot on sales and little on service and support. We spend almost two-thirds of our efforts on service support and the rest in sales. Where do you do your R&D and manufacturing? Application support, labs and chemists are the most of the important segments for us. We have primarily four manufacturing centers--Milford, US; Manchester, UK; Wexford, Ireland and Singapore. UPLC is manufactured in the US and some of our mature products like HPLCs are manufactured in Singapore. In India, we manufacture equipment specifically required by the Indian market, for example the S-10 pumps. How big is the analytical market? It is a $20-billion market worldwide and the liquid chromatography and mass spectrometry account for $5 billion. We have 25 percent share in the worldwide business. Our share of business in Asia is 25-30 percent. The Asia business is getting very close to the Europe market and the US. The Asian market is growing at a very fast speed and we have probably made more investments in the Asia Pacific region than the US and Europe. What are the trends in Asia? We invested in Asia many years ago and we have the luxury of direct operation. Japan is a very mature market. The two big drivers are India and China and the next driving market is Korea. All the three markets are totally different and the only thing common is the growth market. India has built a strong market with the growth of biopharmaceutical industry, CROs and biogenerics. Food safety and environmental concerns are few of the upcoming trends, and hence we are planning to increase our interest in these sectors. So an analytical company like ours has tremendous opportunity. The market is very diverse today. In China we have two big application centers and we have already started with food, environmental and water quality testing there. Jahanara Parveen   ]]> <![CDATA[South Korea, the new Bio-IT convergence hub]]> https://biospectrumindia.com/news/95/1186/south-korea-the-new-bio-it-convergence-hub.html https://biospectrumindia.com/news/95/1186/south-korea-the-new-bio-it-convergence-hub.html Thu, 04 Oct 2007 12:46:00 +0530 New Page 1 South Korea, the new Bio-IT convergence hub Korea gets ready to ride the next big wave. South Korea is making an all-out attempt to power its economy with the IT-BT convergence. Leveraging on its superior Information Technology (IT), the country is looking at creating synergistic combination of biotechnology, IT and nanotechnology. In the Incheon Free Economic Zone, the country's two best universities, Seoul National University (SNU) and Korea Advanced Institute of Science & Technology (KAIST) have mapped out an ambitious $1 billion project called the Emile Project, in the Cheongna District. Also, referred to as the BIT Port, the five-year project (2008-2012) aims to create infrastructure for the next generation scientific R&D by building a BIT complex. This will include a biotechnology complex, IT complex, common facility complex, education and business complex along with a BIT test bed residence and a research-oriented international hospital. The aim is to develop new technology and products through international cooperation model between university, laboratory and the industrial world at home and abroad. Led by KAIST and SNU, this project will take the country among top 10 globally in the field of Bio-IT convergence technologies and products. Just to give you some idea on how big is this Bio-IT convergence industry. According to Korea IT Times, the medical gadget and electronics medical gadgets that comprise most of Bio-IT industry in the existing market is said to be about 10 percent of the medical gadget market and is estimated to be worth $16 billion annually. While bioinformatics and biochip market is said to be $20 billion and $5 billion respectively. In the future, diagnosis and medical treatment will be possible in real time through cutting edge IT technology-based medical gadgets. And Korea is working towards strengthening its position in that future. At the recently concluded, Korean bio-industry showcase event, BioKorea 2007, there was a prototype to the effect on show at the Korea Research Institute of Bioscience and Biotechnology (KRIBB) booth. An enterprising scientist Dr Bong Hyun Chung has gone ahead and integrated the glucose-monitoring device with the mobile phone, which in real time via Internet can transmit the data to the physician. Given that diabetes is acquiring epidemic proportions across Asia the device could be a runaway hit, provided a healthcare infrastructure that supports it is in place. While this prototype awaits commercialization a number of such innovative applications are said to be in development in various labs across the country. Mobile life care and ubiquitous healthcare are the buzzwords in Seoul social circles. According to Korea National Statistical Office, of the country's estimated 50 million population about 16 percent are over the age of 65, and by 2050 this figure will rise to close to 40 percent of the total population. As an ageing society, the country needs huge investments in healthcare infrastructure to meet the needs of such a society. Korea's U-Healthcare System is an effort to address the healthcare challenges of the ageing society. The country's bio-industry is also rising to meet the challenge. In the following pages, BioSpectrum brings you some snapshots from BioKorea 2007, held in Seoul from September 12-14, 2007. The event in its second edition has scaled up in participation and showcases the work that is happening in the industry.   BHM gives Korea its first cGMP certified facility Just a day before the country's largest biotech show-BioKorea 2007-kicked off, on September 11, 2007, BioHeart Manufacturing (BHM) inaugurated its cGMP certified cell culture facility in Seoul. This is South Korea's first such facility. How does MyoCell work? Step 1: A five to 10 gram muscle biopsy from the patient's thigh is performed under local anesthesia, placed in transport media, and shipped to a BioHeart controlled cell culturing facility. Step 2: In the following two-three weeks. The satellite cells are enzymatically dissociated and pure myoblasts are expanded in vitro. After a few passages, myoblast cells are then transferred to increase production. Step 3: Final product MyoCell is then packaged in sterile bags and then shipped to the transplantation site. MyoCell has a shelf life of approximately four days. Step 4: In a surgical cell transplantation procedure lasting 30 minutes Bioheart SR-200 catheter is inserted intravascularly and the cells are injected to the damaged portion of the heart. Result: The damaged heart muscle is partially regenerated with healthy tissue. The implanted myoblast cells proliferate in a controlled manner, contained in the infracted area. The cells are inherently resistant to ischemia and thrive in the oxygen-deprived environment. Jong Weon Choi, CEO & President, BHK Built at an investment of $22 million, the BHM facility is a joint venture between Seoul-headquartered BHK Inc and US-based aBioHeart Inc, with BioHeart holding 18 percent stake in the venture. The facility will primarily manufacture MyoCell, BHK's human adult stem cell medicine. Currently, MyoCell is in phase II clinical trials for NDA. "The trials are on at three sites in Korea and 40 sites in the US," informed Jong Weon Choi, CEO and President, BHK. Keeping in view the fact that it will easily take 6-8 months before MyoCell gets registered in various countries and the manufacturing can begin, Mr Choi has already rolled in motion a plan to utilize the capacities by operating the BHM facility until then as a contract manufacturing organization (CMO) for other products-be it for regulatory approvals or for the market. Talking about the future outlook, Choi elaborated that the goal at BHK is to become a leader in the bio artificial organ industry by consolidating cell therapy, artificial organ technology and digital technology. The company already has artificial heart, lung machine, artificial kidney and liver in the market. Of these, the first two apart from Korea are also being marketed in China, Europe and Netherlands. Recently, BHK tied-up with Getz Medical to distribute its products in the Asian markets and the regulatory approvals in various countries for the purpose are in process.   Mobile to revolutionize healthcare in Korea Dr Bong Hyun Chung Korea's ubiquitous healthcare system has the potential to provide cheaper and smarter ways to manage and care for patients suffering from age-related chronic diseases. In the ubiquitous healthcare system (U-Healthcare System), sensor devices for measuring a bio signal or environment information communicate with the mobile system for collecting bio signals and environment information by wireless personal area network. A number of applications are under development since the announcement of Korea "U-Healthcare System". This national project promising anytime, anywhere healthcare has caught the imagination of the Korean bio-industry. As the mobile healthcare system gets commercialized we will get to see more applications like the one in the picture here. The one shown in the picture is a prototype of a mobile phone, which has a glucose monitoring function via a protein chip integrated into the device. It has the capability to transmit the data to the physician via Internet.   Korea's biotech show scales up South Korea's largest biotech-show BioKorea 2007 in its second edition, this year, recorded over 3,000 participants from across the globe. Close to 150 speakers shared their knowledge and experience with the local industry in the conference session organized in parallel tracks on subjects ranging from contract manufacturing, drug discovery, bioinformatics to technology transfer in Asia. Of these speakers, close to 50 percent were from overseas. This apart, 108 companies participated in the one-to-one business forum partnering meetings. The conference and trade show area packed with industry leaders and students from the many Korean universities showcased the excitement and optimism that is running through the biotechnology industry at this point of time. The government in South Korea has identified biotechnology as the key growth engine for the country. Most recently, the "biomedicine and organ project" has been included among the 10 next generation growth engines, for which the government support and funding has been stepped up. To strengthen South Korea's R&D and infrastructure, the government has made an annual commitment of over $60 billion spread across segments. The country's biotechnology industry comprises 600-odd companies, spread across four regional bio-clusters and 25 centers. Of these, 71 percent companies are working in the area of biomedicine followed by bio-processing and equipment. The plenary session of the conference saw an encouraging announcement. The next edition of BioKorea would be held in October 2008 at Osong Bio-Technopolis located in Chungbuk, Korea. Osong complex is the country's first bioengineering cluster. Launched in 2003, the project is scheduled to finish and be ready for occupation by December 2007. About 22 companies, including CJ Corp., and Jeil Pharm have signed contracts to move into the complex. This cluster, part of a long-term development plan to help the country join the ranks of the world's top 10 bio-science powerhouses by 2010, will also house the nation's four largest state-run health and medical bodies-the Korean Food and Drug Administration, the National Institute for Toxicological Research, the Korea Center for Disease Control and Prevention (KCDC) and the Korean Health Industry Development Institute (KHIDI). Nandita Singh in Seoul, Korea   ]]> <![CDATA[Sweden beckons]]> https://biospectrumindia.com/news/95/1917/sweden-beckons.html https://biospectrumindia.com/news/95/1917/sweden-beckons.html Thu, 04 Oct 2007 12:28:00 +0530 New Page 1 Sweden beckons The Swedish life sciences industry sees a potential for Indian companies for development services and this is an opportunity for India Inc. to foray into Europe With almost a century old tradition in drug development, Sweden has a lot going for it in the life sciences sector. Most of this started with the work done by Astra and Pharmacia which are now known as AstraZeneca and Pfizer respectively. Building on the foundation provided by these two companies, Sweden has now built a vibrant biotech and pharmaceutical industry. The overall story is not very different from other life sciences clusters in the world. A robust healthcare system, innovative biotech sector, large pharma and medical devices manufacturers, industry-academia collaboration, clinical trials hotbed, life sciences clusters etc, Sweden has it all. To facilitate further growth, the country is looking for partnerships and investments from all over the world including Asia and India. The difference seems to be in the opportunities that could be harnessed between Asian/Indian and Swedish life sciences sector working together. To Swedish companies, India represents a potential market with a large number of diabetes patients and other metabolic diseases. India also offers large manufacturing facilities and an easy access to many markets in Asia. The Swedish companies also see a potential for Indian companies to do the development part in R&D. On the flip side, Indian companies could get its Swedish partners to do additional research. Firms from India could also use Sweden as the entry point to the lucrative EU market. Apart from that, the lab facilities in Sweden could be used for the mandatory testing required for drugs manufactured outside the EU. Another aspect that is yet to be explored in a big way is the acquisition of manufacturing facilities in Sweden and other EU countries for contract manufacturing. The Invest in Sweden Agency, the nodal agency responsible for attracting investments into Sweden, has already approached over a dozen leading life sciences companies in India exploring various opportunities. Kemwell: Bucking the trend Contract Research and Manufacturing Services (CRAMS) is seen as a high potential market in Asia. The case is no different in India. According to the Frost and Sullivan report, the CRAMS market in India was valued at $895 million in 2006. While the manufacturing part continues to be the major source of revenues, the other segment of contract drug discovery research are slated to show an annual growth rate of 25 percent. Several multinational companies like GSK and Bristol-Myers Squibb have tied up with Indian companies for both drug development and manufacturing services. Come to India, come to Asia. The trend is loud and clear. So one looks in askance at an Indian company investing in contract manufacturing in Sweden. Last year, Kemwell a Bangalore-based contract manufacturing and development services company acquired Pfizer's manufacturing plant in Uppsala, Sweden. The facility produces salazopyrine known as the first designer drug used to treat arthritis and irritable bowel syndrome (IBS). This is not the only acquisition made by Indian life sciences companies and will neither be the last. Nicholas Piramal has done an acquisition in the UK and Dr Reddy's Lab has bought a Roche facility in Mexico. However, the acquisition by Kemwell is a good indicator that medium size Indian companies also have the opportunity to be global players. According to Anurag Bagaria, vice president of Kemwell, the acquisition enabled the company to gain the vital European footprint for its contract manufacturing ambitions. Being close to the customer is a mantra being heard increasingly in the life sciences sector. The Kemwell acquisition of the Pfizer plant which is approved by the USFDA, the European EMEA and the Japanese regulator is also believed to have been driven by this mantra. "We service 80 countries from our Uppsala facility and this acquisition has helped in increasing our credibility in the international market," said Bagaria. Though the contract with Pfizer is a long term one, Kemwell is in a position to manufacture other drugs as well in this facility. "We will use this facility to do the lab tests for medicines manufactured in India and to be sold in EU. We continue to look for more acquisitions in Europe and the rest of the world," added Bagaria. Kemwell was also able to retain all the employees in the Uppsala facility and in fact encourages interaction with its staff in Bangalore for process and system improvements. Being in the Uppsala BIO region (see box) has also helped as Kemwell looks to building links with the Uppsala University. Biotech pipeline and clinical trials There are around 220 biotech companies in Sweden and almost 80 percent of them are into drug development. Most of these companies are small in size and not many of them are profitable either. What augurs well for the industry is that almost all the companies have some work being done in collaboration with the Swedish universities. The interesting aspect of this collaboration is that the intellectual property developed at the university lies with the researcher and hence the very high rate of academiaâ€“industry partnership. There are currently 110 projects at various stages of development in the biotech companies in Sweden. Almost 40 percent of the projects are in clinical trials phase II and III while 60 percent are in phase I or late pre-clinical phase. AstraZeneca itself accounts for 59 of the 110 projects that are currently in various stages of development. Not surprising as 40 percent of the company's global R&D workforce is based in Sweden. Clinical trials are another area for which Sweden is well known. The use of a 11 digit personal identification number and the existence of population, health, drug and disease specific registers are a big source of help for clinical trials. The personal identity number that has been in use since 1947, enables linkage of exposure and outcome data dating back several decades. Several biobanks have also been built up, both during routine heath checks as well as during specific research projects. This means epidemiological registers can be used for genetic studies. "The Swedish society has a positive attitude towards biotech and the people are more willing to participate in clinical trials," said Yiva Williams, director- life sciences of the Invest in Sweden Agency. The index of optimism for biotech in Sweden is only second to Spain in Europe according to a study conducted a couple of years back by the London School of Economics. There are apparently close to 50 life sciences projects currently in Sweden that have not yet partnered with pharma companies. That represents an opportunity for Asian companies to invest in Sweden and gain the European footprint. Invest and benefit is the Swedish call. Detta representerar en mÃ¶jlighet fÃ¶r asiatiska fÃ¶retag att investera i Sverige och skaffa sig ett europeiskt fotfÃ¤ste. Investera och ta vara pÃ¥ fÃ¶rdelarna Ã¤r det svenska erbjudandet. E Abraham Mathew   ]]> <![CDATA[Biotech patents in Europe]]> https://biospectrumindia.com/news/95/2744/biotech-patents-in-europe.html https://biospectrumindia.com/news/95/2744/biotech-patents-in-europe.html Thu, 04 Oct 2007 11:56:00 +0530 New Page 1 Biotech patents in Europe This article by Dr Ralph D Kirsch and Dr Thomas Westphal explores various options for Indian life sciences companies for filing and obtaining patents in Europe. Ralf D Kirsch & Dr Thomas Westphal Patent Attorneys and Attorney at Law Hamburg, Germany   Before starting to think about getting a patent in Europe, we have to mention that there are certain national requirements in India, such as the compulsory filing of a national patent application in India first and the "foreign filing license", on which you should consult Indian patent attorneys. A biotech company can get patent protection for their inventions in Europe by three routes. The PCT route as the way of choice Filing national patent applications separately in selected European states is obviously complicated and expensive. One easier option is to file a European patent application at the European Patent Office (EPO) in Munich. However, the way of choice for Indian biotech companies is an international patent application under the Patent Cooperation Treaty (PCT) to which India is a party since December 7, 1998. The PCT route is subdivided in two phases, a first "international phase" and a second "regional phase". Initially, the PCT application is filed at a Receiving Office (RO), which can be, e.g. the head office of the Indian Patent Office in Calcutta or the International Bureau of the World Intellectual Property Organisation (WIPO) in Geneva. This starts the international phase, which is relatively cheap and usually takes 30 or 31 months time, during which the applicant can decide on what to do with his patent application (e.g. find a licensee or continue by himself). After those 30 or 31 months, respectively, the applicant can chose in which regions/countries he wants to continue with his application, e.g. he can choose to start the regional phase in Japan, India, the US and/or Europe and enter the European regional phase via the EPO. Entering Europe: the new EPC2000 Once having started the European regional phase via the EPO, the application is handled under European Patent law, i.e. the European Patent Convention (EPC). By December 13, 2007 at the latest, the new EPC2000 will come into force, which will revise and replace the older EPC of 1973. One of the few changes in material patent law of high relevance for biotech companies is the "purpose-related product protection" for any further medical uses of products. That means that the applicant can get protection for any further specific medical use of a compound, e.g. "formulation A for use in the treatment of disease Y", even if a first medical use of this formulation was already known for the treatment of disease X. At the moment, applicants still need to use the rather complicated "second medical use claim format" to get claims aimed at such medical uses, but the new EPC2000 will replace this with the easier wording shown above. This should be a real incentive for biotech companies all over the world to have a closer look at protecting the medical uses of their formulations. For Indian pharmaceutical companies this should be of particular interest, since the patenting of new uses of known substances is not allowed in India under the Patents Act of 1970 (amended 2005). While such new medical uses of known substances are not protectable in India, they surely are in Europe, and this needs to be considered already at the stage of drafting the PCT application before the international filing date. Adding passages to the description that describe this new medical use of a known compound or formulation at a later stage after the international filing date is not possible and will not be accepted by the EPO. That means that Indian biotech companies need to consider very carefully what to put in their international patent application before filing if they plan to enter the European regional phase later on. The European patent as a valuable asset One thing to consider for e.g. a small Indian biotech company is that a European patent application as well as the granted European patent can be seen as a valuable "asset". That means that it is by no means necessary that the applicant has got to fight the patent through to grant in Europe by himself. There is also the possibility to find a licensee for the patent application, who will be willing to carry the somewhat more substantial costs in prosecuting the application to grant. Of course, there is also the option to sell the patent application or the patent. Irrespectively of whether the Indian biotech company wants to actually enter the European market itself, a European patent can be a valuable asset in an important market that can be sold or licensed to another company or used by the applicant himself to protect his position in Europe. Dr Ralf D Kirsch and Dr Thomas Westphal are both patent attorneys and partners in the IP law firm GLAWE DELFS MOLL in Germany (Hamburg, Munich, www.glawe.de). Dr Ralf D Kirsch studied biology and went into research in molecular biology, immunology and biochemistry at the University of Cambridge, UK, and at the Max-Delbrueck-Centre for Molecular Medicine in Berlin, Germany (kirsch@glawe.de). Dr Thomas Westphal studied biology and spent years in research in genetics, molecular biology and biochemistry at the Lomonossow University in Moscow and at the Martin Luther University in Halle, Germany.   ]]> <![CDATA[Nanobiotech gets increased attention]]> https://biospectrumindia.com/news/95/1543/nanobiotech-gets-increased-attention.html https://biospectrumindia.com/news/95/1543/nanobiotech-gets-increased-attention.html Thu, 04 Oct 2007 11:26:00 +0530 New Page 1 Nanobiotech gets increased attention Nanobiotech is slowly gaining momentum in India. ASSOCHAM recently organized a forum on nanotechnology in Delhi and Karnataka has announced a nano event, Nano 2007, that will be held in December. The signs are promising. In January this year, Dabur Pharma launched a novel nanotechnology-based drug delivery system, Nanoxel, for the anti-cancer drug paclitaxel. This nanoscale drug delivery system is India's first indigenously developed nanotechnology based chemotherapy agent. The anti-cancer drug Nanoxel, based on the principles of nanotechnology, is a cremophor-free water soluble formulation and is indicated as an effective and safe therapy for advanced breast, non-small-cell lung, and ovarian cancinomas. Dr Anand Burman, chairman, Dabur Pharma, at the launch said, "We are very excited to launch the first nanoparticle drug delivery system outside of the US." The company has two patents for the drug delivery system and formulation and started the nano-based research in 1997 and now has about 10 molecules in the pipeline according to Dr Rama Mukherjee, president, R&D, Dabur Research Foundation. Dr Burman did not wish to speculate on the revenues the product would generate but said that the new product was superior and would take over conventional formulations, although the company was not considering phasing out its own existing paclitaxel products. This is one of the first cases of nanotech-based products coming out of India. Global nanobiotech market Experts project a $3 billion worldwide market by 2008, with an annual growth rate of 28 percent. The US market will generate 65 percent of global demand for nanobiotech products, market research experts predict. Nanotech is estimated to be a $1-trillion global market by 2015. Diagnosing and treating cancer is a major focus of many nanobiotechnology researchers. Cancer clinics already use nanotechnology such as liposomes that deliver treatment to specific tumor sites and DNA chips that make it easier to read large numbers of genes at a time for key diagnostic information. A tremendous value of nanotechnology applications to cancer treatment is development of the ability to dramatically reduce or to eliminate side effects by precisely targeting treatment to only diseased cells and leaving healthy cells alone. Nanotechnology has still a long way to go. The main reason for such a big hype over nanobiotechnology is the benefits it can bring to medical advancement, at least in theory. When one talks about nanobiotechnology and nanomedicine, one means enhanced drug solubility--the ability of particles to cross biological lipid membranes to enter cells and cross the blood brain barrier. However, this comes at a price as the quantum dots in the nanoparticles pose potential health risks for humans. For example, it has been reported that water-soluble fullerene molecules (nanomaterials) can cause brain damage in largemouth bass. Similarly, dendrimers (another nanomaterial) have been shown to cause osmotic damage, activate the clotting and complement systems and rip off membranes. Moreover, nano particles composed of metals such as selenium, lead and cadmium can be toxic to organisms if these metals manage to leak out of the particles. In addition, one school of thought believes that nanoscale materials neither act like particles nor like chemicals. The properties they possess could be anywhere in between (intermediate) or they could be totally unique. Swapan Bhattacharya, managing director, TCG Life Sciences said that India has for long been fighting diseases like malaria, polio and cholera with blockbuster drugs from the West. But these drugs are not effective in majority of the population and also with more challenging diseases such as cardiovascular diseases and diabetes, the mission is to discover new and more effective drugs. But the drug manufacturers today are facing challenges like high cost of research, decreasing productivity and failure of drugs during clinical process and during marketing. In order to meet the needs of the customer, the application of science has to change, and this is where personalized medicine, also referred to as translational medicine comes into play. We need to take information from clinic and patients to the drug discovery level. "India is not at par when it comes to drug discovery because of lack of right regulatory environment and infrastructure facilities, but at the same time, we do have the right scientific talent. India has 27 new entities in different stages of clinical trials and given the genetic biodiversity that we have there is a lot of potential yet to be explored." He further stressed that nano and biotechnology, physics and chemistry should converge to serve the purpose of advance science. Talking about the application of nanotechnology in the future and the synergy between biotechnology and nanotechnolgy, he concluded, "Nanotechnology is a tool whereas drug discovery is a process, the synergy can be achieved with nanotechnology helping in effective and targeted drug delivery that is something that we can look towards in the future." The sheer breadth of nanobiotechnology and the expense of researching it requires strong collaboration between research institutions. In Texas, for example, nanobiotechnology research and development is conducted through a state-aided alliance of 15 universities in which all institutions contribute to the alliance and all share in the returns. Initiatives in India The New Millennium Indian Technology Leadership Initiative program of the Council of Scientific and Industrial Research (CSIR) is also promoting two public-private collaborative ventures for developing nanotechnologies that target drugs to exactly where they are needed in the human body. In April 2004, former President Dr Kalam organized a meeting of nanoscience experts to devise a national mission plan. The experts recommended that $200 million be spent on nanotechnology over a five-year period. India's finance ministry has now cleared these funds for use in 2006-2011. From later this year, the new national mission will oversee activities currently under the Nano Science and Technology Initiative (NSTI). The government has made a budgetary provision of Rs 1,000 crore to promote the sector. The Nano Science and Technology Initiative (NSTI) has funded about 100 basic science projects worth Rs 60 crore. This would also support establishing centres for nano science at several institutions such as the Indian Institute of Science, Bangalore, and different IITs. The Amirta Center for Nanosciences was established in May 2006 as one of the seven nanotechnology centers funded by the Goverment of India under the Nanoscience and Nanotechnology initiative and is the only one in the biomedical area. Sabeer Bhatia of "Hotmail" fame is investing $10 billion into the setting up of a "NanoCity" an environmentally sustainable development. It was unveiled in April 2006 by entrepreneur Bhatia and the Haryana state government. Modeled after Silicon Valley, Nano City will feature R&D and educational centers and corporate offices for technology, biosciences and other knowledge industries. Nanotech implications The rise of nanotechnology is viewed to be a potent phenomenon in the biotechnology market and the positive trends can be marked on the stock market. High-level scientific research in the field has been bolstered by heavy capital investments pouring in on account of the great potential. It has also opened new avenues. Nanobiotechnology applications are predominantly in the research and development phase. Over $3 billion in public funding was available worldwide for nanotechnology research in 2003, with around 8 percent dedicated to the nanobiotechnology sector according to some market reports. Public and private investment are sponsoring research projects in academia and facilitating the establishment of start-up and spin-off companies with the purpose of commercializing nanobiotechnology applications. It is now the responsibility of the market participants to incorporate the technology in commercially viable products. Funding has been used to set up sound infrastructure, particularly in the US and Europe, for small companies to network and collaborate; but in India everything is still at very initial stages. It is essential for industry participants to be aware of what funding sources are available and where, as this indicates hot spots for business opportunities. An increasing use of nanobiotechnology by the pharmaceutical and biotechnology industries is anticipated. Nanotechnology will be applied at all stages of drug development--from formulations for optimal delivery to diagnostic applications in clinical trials. Many of the assays based on nanobiotechnology will enable high-throughput screening. Some of nanostructures such as fullerenes are themselves drug candidates as they allow precise grafting of active chemical groups in three-dimensional orientations. The most important pharmaceutical applications are in drug delivery. Apart from offering a solution to solubility problems, nanobiotechnology provides intracellular delivery possibilities. Skin penetration is improved in transdermal drug delivery. A particularly effective application is as nonviral gene therapy vectors. Nanotechnology has the potential to provide controlled release devices with autonomous operation guided by the needs. Nanomedicine is now within the realm of reality starting with nanodiagnostics and drug delivery facilitated by nanobiotechnology. Miniature devices such as nanorobots could carry out integrated diagnosis and therapy by refined and minimally invasive procedures, nanosurgery, as an alternative to crude surgery. Nanotechnology will markedly improve the implants and tissue engineering approaches as well. Public expenditure for nanotechnology development in India stays around $7 million per annum as against $395.5 million of Germany, $301.1 million of France, $180 million in the UK, $ 233.5 million in South Korea and even $102.4 million Taiwan, according to The Associated Chambers of Commerce and Industry of India (ASSOCHAM). Amazingly, India also fares relatively lower in funding of nanotechnology projects by the private sector. While the contributions of the private sector to the total funding vary from more than 50 percent in the US, 60-70 percent in Japan, and 36 percent across emerging Asian countries, that in India is close to 22 percent. Europe leads the global nanotech based scientific publications by a share of almost 41 percent followed by the US and Canada with 24 percent, Japan 13 percent and rest of Asia Pacific with 14 percent. In India, the percentage is as meager as that of 8 percent according to ASSOCHAM. Despite all this, India's growth in nanotechnology is measured in double digit. The UK has joined hands with India to establish a joint Nanotechnology Working Group to speed up the development of new technologies. The group will be officially launched within the next two months as part of the government's drive to promote the UK's nanotechnology sector on the international stage. The nanotechnology initiative between India and the UK will help create an environment that sparks co-operation. The EuroIndiaNet FP6 funded project aims to promote stronger collaboration between EU and Indian scientists and industrialists in the areas of the nanosciences and nanotechnologies. The project aims to promote stronger collaboration between EU and Indian scientists and industrialists in the areas of the nanosciences and nanotechnologies through a comprehensive description of current policies, funding strategies, training programmes and support structures for nanotechnology R&D in both India and the EU. Nanobiotech companies A number of nanobiotechnology companies have emerged recently, that are looking at therapeutic benefits of nanomaterials. Nano Cutting Edge Technology-Nanocet, a R&D nanobiotechnology company, is pioneering the development of uniquely advanced biostabilized nanoparticles technology in the areas of cancer hyperthermia, targeted drug delivery, diagnostics, antimicrobial agents and treatment of pollutants. Qtech Nanosystems is a nanotechnology company, developing nanotechnology products for various applications, with the aim to propel innovation in Nanotechnology. Qtech Nanosystems aims to emerge as a premier collaborative research and new product development and launch center in nanotechnology achieving breakthroughs in technology, cross-functional collaboration and bringing best-of-class practices and knowledge to the forefront. Qtech Nanosystems is not directly working on nanobiotech products as off now. It is basically working on products related to nanodynamics (precise control of "objects" in sub-nanometer scale), which in fact has applications in nanobiotechnology. Qtech is suspending its Indian operations and have shifted its corporate office to Singapore and shifting of R&D is in course. Bangalore-based Velbionanotech is designing drugs for various diseases such as heart, kidney stones, AIDS, cancer, and cosmetic generic products using a short fragment of DNA as a new type of drugs. These drugs are assembled in nanochips and as nano particles for delivering in human body, which are affective in curing the sick/diseased and healing the injured. VBN is working in new gene therapy procedures, DNA-based sensors, and other medical applications by using a new method developed to initiate and control chemical reactions on DNA strands. On the other hand silicon-based nanochips with itching and self-assembling techniques used to deliver drugs on the diseased molecules. Although the benefits of nanobiotechnology are huge, there are certainly many hurdles ahead. Nanobiotechnology presents unique opportunities and challenges on the intellectual property front as well. Faced with many disappointments in the past, the main question still remains-will nanobiotechnology deliver the promises of biotechnology? Jahanara Parveen   ]]> <![CDATA["Kendle plans to increase its clinical development activities within India"]]> https://biospectrumindia.com/news/95/2269/kendle-plans-to-increase-its-clinical-development-activities-within-india.html https://biospectrumindia.com/news/95/2269/kendle-plans-to-increase-its-clinical-development-activities-within-india.html Thu, 04 Oct 2007 11:21:00 +0530 New Page 1 "Kendle plans to increase its clinical development activities within India" -Bharat Doshi, Country Manager, Kendle India Kendle India was incorporated in December 2004. With a staff of 18 clinical research professionals, Kendle India is a global clinical research organization (CRO) that provides phase I-IV clinical development, regulatory affairs, biometrics and late phase services to help the world's biopharmaceutical companies maximize product life cycles and grow market share. Kendle's team in India possesses clinical research and project management experience, plus broad therapeutic expertise. Bharat Doshi, Country Manager, Kendle India, shares with BioSpectrum the company's India plans and achievements. What have been your key achievements in 2006-07? Kendle India grew at more than 100 percent in terms of head-count and revenue. We increased our exposure to research sites by approximately 200 percent. And we have started covering neighboring countries, such as Sri Lanka, Pakistan, Bangladesh and have placed a contract CRA in Thailand. What are the different services that have been introduced? Kendle competes and has competitive advantages in the following core competencies: Global clinical development, which provides Phase I-III clinical research services to biopharmaceutical companies across a broad spectrum of therapeutic areas Regulatory affairs, which provides consulting and submissions and pharmacovigilance/safety services to help guide customers through the regulatory maze to avoid pitfalls, obtain approvals faster and maintain compliance Biometrics, which provides clinical data management, biostatistics and scientific programming services that expedite the clinical development process Late Phase, which provides proactive and innovative designs for Phase IIIB/IV studies and value-added pre- and post-launch services to leverage study result What were the company's revenues? Kendle reports revenue by geographic area. Net service revenues for the first quarter of 2007 were $95.4 million, of which 50 percent were in North America, 43 percent in Europe, 4 percent in Latin America and 3 percent in the Asia Pacific region. What are the new partnerships and alliances that the company entered into in the previous year? Worldwide, Kendle International acquired the Phase II-IV business of Charles River Laboratories last year. Locally, Kendle India increased its usage of research sites (hospitals) by 200 percent more than the previous year. This included all big sites such as All India Institute of Medical Sciences, Post Graduate Institute of Medical Education and Research, Christian Medical College and King Edward Memorial Hospital. We trained five new sites last year on ICH-GCP standards and gave them an opportunity to participate in international clinical research. What are the investments in terms of infrastructure, new plans and projects and the studies undertaken? Kendle has expanded the capacity of its office based in Gurgaon from 12 to 50 associates. From this office, Kendle plans to increase its clinical development activities within India and also in the region. This will mean more clinical studies being done in India. Simultaneously, we will expand our headcount at this new office and when it approaches capacity, we plan to move to another office location within India. We will consider offering other services also from the same office. In terms of more number of clinical trials, we intend to work with more sites and train more new resources for clinical research activities. What are the key challenges? And how do you plan to overcome them? Attracting appropriate talent is a challenge, and it is complicated by the fact that many employees change jobs quite often. We are overcoming these challenges by offering an aggressive compensation and benefits package and by providing an environment that strikes a work-life balance. In addition, we try to "grow our talent" by encouraging associates to gain additional knowledge and skills, leading to additional career options within Kendle. A key to this is Kendle College, our proprietary, industry-leading training and educational organization that provides a wide variety of interactive learning opportunities including self-paced courses and live collaborative experiences. Shalini Gupta   ]]> <![CDATA['Collaboration with local CROs is a good strategy']]> https://biospectrumindia.com/news/95/1466/collaboration-with-local-cros-is-a-good-strategy.html https://biospectrumindia.com/news/95/1466/collaboration-with-local-cros-is-a-good-strategy.html Thu, 04 Oct 2007 11:17:00 +0530 New Page 1 'Collaboration with local CROs is a good strategy' -Pey Ni Chan, Executive Director, Global Business Development, EPS Ever Progressing System (EPS) International, a leading Japanese CRO is primarily involved in activities like clinical research, site management and pre-clinical businesses. EPS provides staffing service, pharmaceutical- and medical-information system development, as well as software development and CRO services in China, SouthEast Asia, and Oceania. Recently, the company started operations in Taiwan. With growing market trends, EPS has established a structure which can provide a full range of services from pre-clinical study to post-marketing study. It offers long-term and large-scale studies in the areas of cancer and circulatory diseases, which are among the top three causes of death in Japan. Moreover, it has developed a reputation for high quality data management because of its involvement in software development relating to the pre-clinical study stages prior to entering the CRO business. Pey Ni Chan, Executive Director, Global Business Development, EPS International, shares her views with BioSpectrum about opportunities for CROs in the Asia Pacific region. Excerpts of the interview: What is the current CRO market scenario in Asia Pacific region? There has been a rapid increase in the outsourcing of clinical trials in the Asia Pacific region especially in key Asian emerging countries. The main drivers for this increase are cost, speed, regulatory infrastructure and commercial value involved in the CRO market. In addition, the acceptance of the clinical trial data by the US FDA for pivotal studies from Asian countries has been encouraging. What advantages do the key Asian countries have for conducting clinical trials? The key advantages for conducting clinical trials in the region include regulatory support, capacities and capabilities and finally low operating costs. The operating costs include fees for IRB and regulatory purposes, site professional fees, patient study cost, site start up costs, logistic costs and so on. In terms of capacities, the key Asian countries have most experienced investigators who are trained in the US and Europe and have actively participated in the international clinical research and publications. These countries have good clinical research centers that provide dedicated research coordinators to support all trial activities. Besides, they also have the presence of major global, regional and local CROs, central laboratories and clinical suppliers. In terms of capabilities, these countries have good patient compliance, availability of standard treatment modalities and availability of diverse patient groups and also follow international medical practices. What are the challenges that the CROs are facing in the region? Different regions are facing different issues. It is not necessary that all countries in the region should have the same issue. The key challenges, in Japan, Korea, and Taiwan include English language, differences in local and cultural practices and accessibility of regulatory and IRB information. In addition to these, Japan has other issues such as patient recruitment and obtaining informed consent from the patients. However, this is not a major area of concern in Singapore and Hong Kong. Availability of patient pool is a key challenge as far as Singapore is considered. According to you, what strategies can help CROs overcome these challenges? It is necessary to have strong local clinical operations team with bilingual ability. Second strategy could be entering into collaboration or working with the local CROs who have good track record. And the third could be conducting comprehensive feasibility studies to meet the global clinical development strategy and timeline. Narayan Kulkarni     ]]> <![CDATA['We've the best outlook for China']]> https://biospectrumindia.com/news/95/8485/weve-the-best-outlook-for-china.html https://biospectrumindia.com/news/95/8485/weve-the-best-outlook-for-china.html Thu, 04 Oct 2007 11:12:00 +0530 New Page 1 'We've the best outlook for China' -Albert Liou, Chairman & CEO, Apex International Earlier this year, Apex was listed on the Emerging Stock Market in Taiwan. The company headed by Albert Liou assists more than 150 pharmaceutical, biotech and medical device companies worldwide. In an interview with BioSpectrum, Albert Liou, Chairman and CEO, Apex International Clinical Research, elaborates on how the company is meeting the key challenges in the CRO business. Apex assists more than 150 pharmaceutical, biotech and medical device companies worldwide. How does the company handle all the clients? Just within Apex, we cover 12 countries with 350 employees, and this means that within this region there are more than 10 different official languages and more than 50 different dialects spoken within the Apex team. Apex in itself is very appreciative of culture diversity, culture recognition, and understanding of different perspectives. Therefore, as we serve all our clients worldwide, we apply the same attitude. There is always a common goal between the client and us, i.e., the timeliness, quality, and cost-effectiveness of clinical research. As we keep these three priorities in mind, we are able to satisfy our client's needs. In addition, even though we appreciate the cultural differences, we do keep a very standard set of operating procedures in place. For example, for project management, we keep 16 plans in place to allow our project managers to maintain everything in place and on time. Plus, we focus on planning and strategy setting. We can take IND submission as an example, for every specific project, we would develop a unique regulatory strategy and planning to ensure we can smoothly implement the trial in Asia Pacific. Furthermore, we also proactively provide solutions to our clients based on our local know-how, experience, and expertise in this region. Lastly, it is truly important to remain in close communication with our clients, and the information must be transparent and easy to understand. By sticking to the above points, we can definitely offer good quality services to any clients worldwide. What according to Apex is the most competitive location for conducting clinical trials in APAC? Each country has its strengths and limitations in conducting clinical trials, and it definitely requires extensive knowledge of the requirements from the product development side and what the country can offer. For example, not all countries share the same standard medical practice or national medical insurance policies; these factors may well impact the selection of countries to participate in a global trial. Having said that, we still have the best outlook for China. According to IMS, China will become one of the top five pharmaceutical markets in the world due to its forecast pharmaceutical growth in the next three to four years. Therefore, many pharmaceutical companies will aim for that market and continue to develop products there. How challenging is the CRO business and what is Apex doing to meet those challenges? The key challenge for any CRO is primarily the resources issue. It is essential to have the expertise and professionals within the organization to deliver excellent service to our clients. Apex deploys many different strategies in building the team. For example, since 2006, Apex established a CRA training academy. For each tier, Apex selects from over 300 resumes to pick out the most suitable candidates, based on their related background trainings. We require them to go through English proficiency test, intense interviews, and orientations to ensure we pick the best ones in the group. We then train them with three-week in-class training with assessment examinations and then take the trainees to go through a mentoring program for another three months before they can formally graduate from the academy. Basically, it is the first and only program, which provides solid training for the CRAs. We have many requests from pharmaceutical companies asking us to train their staff for them. This is only one of the few programs, which we establish within Apex to overcome the challenges we face. Hasthana Rajappa   ]]> <![CDATA['We will go global with high-end research service offerings']]> https://biospectrumindia.com/news/95/1373/we-will-go-global-with-high-end-research-service-offerings.html https://biospectrumindia.com/news/95/1373/we-will-go-global-with-high-end-research-service-offerings.html Thu, 04 Oct 2007 11:07:00 +0530 New Page 1 'We will go global with high-end research service offerings' -Dr Shiv Prakash, CEO, Synchron Research India-based Synchron Research started as a one-room kitchen in 1998 and since its inception the company has grown 100 percent every year. In 2006, global CRO Parexel invested in Synchron as a strategic investor, and the company also started its Bangkok operations. In 2007, Synchron acquired Ahmedabad-based start-up CRO Innovance. In an interview with BioSpectrum, Synchron Research CEO, Dr Shiv Prakash outlines the growth trajectory for the next five years. What is the USP for the company and how is it positioned vis-a-vis competition in the market? Synchron has always been a unique company in many ways. First of all, the promoters are professionals and experts in the area of clinical research. Most of the CROs in India are supported by pharmaceutical or other industries. They have the capability to invest money and scale up operations. Synchron has withstood such competition and has grown on its own in all these years and will continue to grow independently. What kind of competition do you face while pitching for business? Quality is the most important parameter. Cost is another consideration as far as competition goes. Indian prices are already competitive because of CRO business growth. However, it has grown like wild fire without any proper direction. Everybody wants to milk the opportunity without any firm plans. This is not a good sign for us. This is creating uncertainty in business development. What is your vision for the company for the next five years and how does your recent expansion to Thailand fit in the scheme of things? I had the vision that CRO business will be a mainstay in India way back in 1998 when I started the operations of Synchron in Ahmedabad in a one-room kitchen. The Synchron business plan has been on my mind since 1994. My vision is to make Synchon a drug discovery partner for pharmaceutical companies. Synchron will not be just a BA/BE company for long. The company will go global with high-end research service offerings. We will introduce high throughput screening for new molecules, biomarker facility for global trials, central labs only for clinical trials and dermatology research. I have identified Thailand as a potential country in SouthEast Asia for our growth. Like in India, we are also the first CRO to start operations in Thailand to cater to the virgin SouthEast Asian market. We would find ways to expand our global footprint in Asia into other countries and also we will explore the possibilities to cover Europe, this year. The goal is to make Synchron the largest high-level research service provider in India. I would take pride in building the most scientifically oriented company rather than a mere commercial venture. I believe that good science eventually will make lots of money in the long run. Please elaborate on the regulations in India that you think can be improved upon and in what way? Regulatory scenario in India has improved tremendously. The Indian regulatory guidelines are much better compared to other Asian countries. There is more awareness of regulatory aspects in India and the regulators are scientifically aware. By allowing phase I trials in India, one more hurdle has been removed. If the regulatory authorities can bring different aspects of permission like import of drugs, grant of export permission for biological samples, clinical trial permission under one umbrella under one authority many more problems and delays will be removed. This will further improve the clinical trial business in India. Nandita Singh   ]]> <![CDATA['The industry needs to maintain its focus on developing human resource']]> https://biospectrumindia.com/news/95/2376/the-industry-needs-to-maintain-its-focus-on-developing-human-resource.html https://biospectrumindia.com/news/95/2376/the-industry-needs-to-maintain-its-focus-on-developing-human-resource.html Thu, 04 Oct 2007 10:58:00 +0530 New Page 1 'The industry needs to maintain its focus on developing human resource' -Yutaka DeSilva, Director, Global Sales, Quintiles-APAC Everyone has an eye on Asia in terms of both market and R&D potential. As the market becomes increasingly competitive, being able to provide consistent delivery and innovative solutions will be the key to global success. In an interview with BioSpectrum, Yutaka DeSilva, director, global sales, Quintiles-Asia Pacific talks about the key challenges for the CROs in the Asia Pacific region. Some excerpts: What are challenges that CROs like Quintiles are facing in the Asia Pacific region? When looking at the overall clinical development landscape in Asia, there are essentially two key challenges that the industry, including Quintiles, will face in the coming years. First is a remarkable high growth on a relatively small base and second is the execution and delivery in an increasingly competitive market. The CRO industry globally is growing at a healthy 10-15 percent. In Asia, the industry is looking at three-four times of that. Considering 30-40 percent year-on-year growth on a relatively small pool of professionals and infrastructure, there is a high demand for staff and talent across the board. The entire industry needs to maintain its focus on developing human resources and offering rewarding, long term careers. Quintiles has invested a great deal in setting up the systems to identify, develop, and retain talented professionals and these strategies are meticulously planned, communicated, executed, and measured. Of course, the end goal of these efforts is ultimate consistent delivery with the highest quality. In pharmaceutical development, gaps in patient safety, regulatory compliance or data quality is not an option and global consistency is key to the success of any development program. For that, there needs to be execution of process. Upfront planning, critical assessment of risk factors, and adherence to global standards for every project are paramount for consistent delivery. Everyone has an eye on Asia in terms of both market and R&D potential. As the market becomes increasingly competitive, being able to provide consistent delivery and innovative solutions will be the key to global success. How do you see competition in the CROs space in Asia Pacific? Looking at cost and development pressures on pharmaceutical and biotechnology companies, I believe the CRO market both globally and especially in Asia will remain bullish for some time to come. We're also seeing growth coming from all directions including the expansion of traditional global development, alternative partnership models, the maturation of Asia-based biotech and pharmaceutical companies with compounds in the clinic, and innovative development strategies like the inclusion of Asian patient data into marketing applications in Japan. In this environment, companies with a global footprint will advance in the market as they can promise access to patients around the world. Many of the international players are gaining momentum in Asia including PPD, Covance, Icon and Omnicare. Parexel is also looking to take a significant strategic position in Asia. We are, however, at least twice as large in terms of number of staff and geographic footprint and plan to continue leveraging this, and our local expertise in the region to maintain our market share. Which country in Asia Pacific, according to you, is the preferred CRO destination and why? Asia is a truly diverse region with many opportunities. Each country has its own unique clinical development environment and the key is to understand the intricacies of each market such that optimal solutions are developed to meet the unique objectives of each client. Narayan Kulkarni     ]]> <![CDATA[IVD market on fast track]]> https://biospectrumindia.com/news/95/2618/ivd-market-on-fast-track.html https://biospectrumindia.com/news/95/2618/ivd-market-on-fast-track.html Thu, 04 Oct 2007 10:46:00 +0530 New Page 1 IVD market on fast track Fuelled by strong double-digit growth rates of segments such as molecular diagnostics and diabetes care, the in vitro diagnostic segment is set to take off in a big way, with worldwide sales expected to surpass $44.5 billion by 2010. Advances in human genomics, bioinformatics, miniaturization, and microelectonics-often blended with information technology and computer technology-have led to a growth spurt in the market for in vitro diagnostic (IVD) tests, with worldwide sales expected to surpass $44.5 billion by 2010, according to a 2006 study from Kalorama Information. The global market for IVD, in 2004, stood at $28.5 billion. It is witnessing a good growth fuelled by strong double-digit growth rates of segments such as molecular diagnostics and diabetes care. The molecular diagnostic segment is expected to grow at over 15 percent in the next five years much higher than other sectors. The IVD market accounts for about 38 percent of the total global medical devices and diagnostic market. The other two segments include diagnostic imaging equipment market with a share of 41 percent and the rest accounts for electro-medical devices, according to InteLab Corporation. Routine test segments-chemistry/immunoassay workstations, hematology, and routine microbiology-currently make up about 70 percent of the market test-wise. But intensive price pressure and automation continuously erode the market value of these segments and more expensive nucleic acid, pharmacogenomic tests and immunoassays for cancer, cardiovascular diseases and infectious diseases will begin to overshadow these mature segments by 2010. According to a report from Business Insights, the global IVD market is dominated by a handful of large players with several hundred smaller players competing for market share. Further consolidation within the sector can be expected as pharmaceutical companies seek acquisitions in the diagnostic field to complement their drug development programs in the emerging personalized medicine era. Leading IVD companies Roche and Abbott illustrate the synergies between diagnostics and pharmaceuticals. Both companies have development projects for new biomarkers in the fields of oncology and infectious diseases. Underlining the growing significance of molecular technologies, leading medical technology company Becton Dickinson has increased its participation in the molecular diagnostics sector with the acquisition of GeneOhm, which specializes in healthcare-associated infections, such as MRSA. Companies specializing in diagnostics, such as Gen-Probe, Inverness Medical Innovations and Tm Bioscience, are targeting niche markets. While small companies remain vulnerable to competition from larger players, they have established their market presence through differentiated technology. The innovative technology companies represent a valuable source for larger companies and laboratories. Affymetrix' GeneChip technology is licensed to several top players, including Roche and Johnson & Johnson. Nanogen's NanoChip electronic microarray platform and PCR reagents enable laboratories to develop multiple assays with universal parameters. Consolidation of the IVD industry is highlighted by the dominance of the leading 15 companies, which account for almost 90 percent of the global IVD market. Roche is the major player with a 20 percent market share. The other leading companies include LifeScan of Johnson & Johnson, Bayer, Beckman Coulter, Dade Behring, BD, bioMerieux and Bio-Rad. The acquisition of one of largest IVD companies, Diagnostic Product Corporation (DPC), by Siemens Medical Solutions heralds a trend towards the emergence of new players in the market as in vivo and in vitro diagnostic technologies converge. With the acquisition of DPC, Siemens holds the unique position of being the first company to bring in vitro diagnostics, in vivo diagnostics and healthcare IT under one roof, but faces constant competitive threats from other companies looking to enter the market. However, according to market analysts at Frost & Sullivan, the IVD market holds enough potential to continue attracting such companies to participate and invest either through partnerships or acquisitions. Opportunities to enhance diagnostic management are ample and such alliances and collaborations are beneficial to both companies and patients. Recent acquisitions have also set off a new trend to combine early diagnosis with information technology to create a new "early health" model of care focused on swift diagnosis, pre-symptomatic disease detection and prevention. Asia outlook With the presence of rich pool of innovation and intellectual property, manufacturing capacity, emerging industry players and maturing market-Asia is beginning to experience the surge in IVD market. At present, Asia Pacific accounts for only two percent of the IVD global sales. Over the past few years, the Asian IVD market has been the only region experiencing close to a double-digit growth rate. While an ageing population and widening health insurance penetration are advancing growth opportunities in this high potential market, divergent country-specific social, economic, political and healthcare issues threaten to impede overall market development. The Kalorama Information report predicts that emerging markets, such as South America and Southeast Asia, where rising standards of living have sparked the growing demands for quality medical care, will experience 10-20 percent annual growth. While Japan, EU, and the US markets, accounting for 85 percent of the total IVD market, will begin to lose market share, with their portion of the market decreasing to 80 percent by 2010. Asia's ageing population is expected to double by 2025, increasing the number of people likely to require medical treatment. Rising average life expectancies coupled with more affluence are expected to boost expenditure on healthcare treatments, including IVD. For instance, Japan-with the world's third largest aged population-accounts for 90 percent of IVD market revenues in Asia. In other countries, governments are being confronted with the dilemma of reducing healthcare outlays even while expanding healthcare coverage to all. However, the growing realization of their tremendous financial and therapeutic benefits is furthering the popularity of IVD tests. From being under-utilized and undervalued, IVD tests are now increasingly being regarded as key to improving overall cost efficiency and patient outcomes. Lack of proper health insurance and constrained personal finances has resulted in low levels of consumer spending. In the absence of a strong medical insurance sector, most of the healthcare expenditure is borne by the individuals themselves. It is estimated that 82 percent and 63 percent of total healthcare spending in India and China, two major countries is the region respectively, is "out-of-pocket." This is expected to slowly change with private insurance companies increasing their penetration and introducing some kind of healthcare coverage. According to Frost & Sullivan, clinical chemistry (38 percent) and immunoassay (29 percent) followed by haematology and microbiology are driving the growth of the IVD market in Asia. The fastest growth was, however, recorded by the molecular biology segment followed by coagulation and point of care (POC). Increased adoption of nucleic acid testing (NAT) based infectious diseases and viral assays (molecular diagnostics), blood glucose testing (POC), cardiac markers and glucose (clinical chemistry), coagulation self-monitoring and bacteriology culture (microbiology) is set to support a compound annual growth rate of almost nine percent for the overall IVD market between 2003 and 2010. A prominent trend has been that of cancer overtaking infectious diseases as the leading killer in Asia. This has increased the potential for premium-priced tests for cancer detection. Although the region has traditionally been more of a follower rather than leader in developing and adapting to newer tests, novel, premium-priced assays are poised to replace more conventional testing options. Therefore Asian countries offer a great market potential for IVDs, considering that they account for a small percentage of total healthcare costs. In particular, the development of molecular diagnostic assays used to test newly identified disease targets is fueling excitement over the promise of personalized medicine and theranostics. Global IVD market evolves From being primarily driven by bench top instruments with innovative assays, the global IVD market has continuously evolved over the last decade and is now more focused on larger systems that are integrated with different software and automation components and on developing screening and disease confirmation tests. Innovative technologies are expanding the capabilities of diagnostics, particularly molecular diagnostics which enable earlier and more precise diagnosis. Molecular diagnostic tools are enabling personalized healthcare through patient selection for specific treatment and monitoring of disease progression. Although realizing the potential of new technologies will depend on overcoming challenges such as regulatory and reimbursement hurdles, new diagnostic opportunities will expand the IVD market to over $40 billion by 2010. There are several changes taking place in healthcare provision that are influencing the market for diagnostic products and the dynamics of industry as a whole. IVD companies' abilities to anticipate and react in a timely manner to these changes will, to a great extent, determine the success or failure of new technologies. The fact that patients are taking greater responsibility for their healthcare decisions, and have wider access to information on new technologies, has empowered consumers who are playing a key role in driving demand. Healthcare demand is also fuelled by a rapidly ageing population and the availability of new and advanced technologies. Combined, these factors are placing considerable pressure on healthcare budgets. Faced with rising healthcare costs, private and public payers will require compelling evidence in the form of cost-benefit analysis to support the reimbursement of diagnostic and therapeutic products. In this regard, the development of technologies that enable pre-symptomatic screening and individual patient risk profiles are likely to make a difference by establishing closer links between diagnostics and therapeutics. The resulting "theranostics" will bring more value to diagnostic tests, which are undervalued by healthcare payers and providers. Faced with demands for multiplexing, rapid turn-around time, sensitivity and specificity, while still remaining cost-effective, the challenge for IVD manufacturers will be to strike a balance between the various components of diagnostics systems - chemistry, detection instrumentation technology and software. As technical breakthroughs continue to drive the IVD market, the healthcare industry is becoming aware of their increasingly important impact on the way medicine is practiced. By focusing on predicting patient outcomes, targeted medicine, earlier disease detection and more advanced automation, diagnostics has secured considerable market growth potential. This promises to contribute to significant healthcare cost savings in the near future. The IVD industry is rapidly evolving and is presently more dynamic than in over a decade. Diagnostics currently possess tremendous potential for growth, but harnessing this opportunity requires that market-participants concentrate on efforts to raise awareness regarding the importance and benefits of optimizing patient diagnosis. Understanding individual markets and clinical needs is becoming increasingly important to overcoming obstacles and promoting the adoption of new technologies. Despite several challenges, the IVD market expects to see a great deal of growth, especially as a result of developments in molecular diagnostics and point of care testing. As systems are becoming smaller, more integrated, and increasingly automated, the industry is also beginning to see a shift in priorities toward enhanced customer service efforts and more optimal data management solutions. For a long time, the IVD industry has been fairly stagnant however, recent discoveries have ignited a great deal of excitement over potential medical applications. Consequently, many companies have been boosting investments in research and development, focusing on pharmacogenomics and theranostics. In the near future, innovative technologies will enable physicians to identify disease, choose the ideal treatment, and monitor the patient's response to therapy. This concept of personalized medicine is still in its infancy but is expected to create great opportunities for both the pharmaceutical and diagnostic industries. Narayan Kulkarni   ]]> <![CDATA["We are looking at consolidating our business"]]> https://biospectrumindia.com/news/95/1846/we-are-looking-at-consolidating-our-business.html https://biospectrumindia.com/news/95/1846/we-are-looking-at-consolidating-our-business.html Thu, 04 Oct 2007 10:45:00 +0530 New Page 1 "We are looking at consolidating our business" -Neeraj Gupta, managing director, Imperial Life Sciences Imperial Life Sciences has been on a growth curve ever since it closed three major deals in the last one year with Agilent in November 2006, Invitrogen (January 2007 and Caliper (April 2007). In an interview with BioSpectrum, Neeraj Gupta, managing director, ILS, spells out the future plans of the company. What products have been the revenue grosser for Imperial this year? We have different classifications. In the instrumentation division, we have seen a huge success with our platform for bioanalyzer from Agilent and another platform will be microarray systems, complete workstation. With Caliper we have seen huge success with kinase profiling. These are the three product classifications which have done very well for us in the last six months. We have done a lot of work in stem cell research but the leading one would be cell culture business where we have seen huge growth in our turnover. A large part of it came from bioproduction because the cell culture is used in the vaccination industry, which is growing very rapidly in India. Molecular biology reagents have also seen a growth. They comprise chlorine kits and PCR enzymes. Imaging business has also done well. We are looking to double our turnover from the last financial year. Almost 100 percent growth has already been achieved in the first six months of this year (2007). We are planning to close this financial year with a 30-40 percent growth over our last year's performance. A month back we have collaborated with Xenogen. They are partners worldwide in live in vivo imaging. Live in vivo imaging is a very important technology for drug discovery for pharma companies because here we do studies on live animal models, we infect them with a specific disease and then give them therapeutics. This is a more advanced technology and we are entering into it in a big way How do you differentiate yourself from your competitors? We have divided our business into two divisions-instruments and reagents and consumables. These have separate teams of people but they work in tandem with each other and this is what gives us an edge over any other competitor we have. For example, an instrumentation company in India will just have an instrumentation portfolio and they will have a relationship with the customer only at the time when the need is there. On the contrary, we being a reagent supplier as well, have a relationship with each and every customer in some or the other way and hence come to know about those needs much earlier than our competitors and hence we can do a satisfactory customer relationship. So this complete blend of instruments and reagents business gives us a definite advantage. They complement each other. We count this as the biggest strength of ILS. What are the new innovative methods being adopted at ILS? ILS is bringing ILS-Invitrogen Day and ILS-Agilent Day into the market which is something that we started as recent as last week. But it has been so successful that we are thinking of replicating the model in the coming months in rest of the country. We had a technical team of 10-12 people from Invitrogen and a sales team of 4-5 people from ILS spend the whole day at a couple of institutions in Bangalore and Hyderabad doing a lot of demonstrations and technical interactions with different customers and positioning products. This was extremely appreciated by top leading scientists at these institutions and also got us a lot of good prospects. Can you elaborate on the marketing strategy of ILS? It is a three-pronged strategy that includes: Sales team: We have a very strong network of sales team and a few distributors working for ILS. They are basically technical people with scientific and research background who have been trained about the products. They are in the frontline and interact on regular basis with our customers. Product management: This division has application scientists and product specialists. Application scientists work in close proximity of the customer at his/her location. So they have a focused account and can understand the needs of the customer better. This is an innovative marketing strategy. Bioservices: The customer comes to our facility to get the sampling done and brings a lot of business for us and we can position a lot of different products to the customer. The company entered into many deals last year. Are you looking at any more deals this year? We are looking at consolidating our business because Invitrogen itself brings with it 9-10 companies which they acquired last year. So we are in the process of consolidation. We are trying to strengthen our product segments which are complementary so that we are able to reach our common goal which is to become a one-stop shop. Our partnerships have helped us achieve this to some extent and we are in the process of strengthening our partnership with other vendors with the same vision. Are you looking at other markets as well? We are purely concentrating on business in India. There are some parts in Sri Lanka, Bangladesh and Nepal. We will be expanding our business segments in the Asian subcontinent, in the SAARC countries particularly. What is the vision of ILS and how have you been working to achieve it? The vision of ILS is to be partners in research module. We don't just want to be a supplier of products but also sell the customer the technology to use it. We do a lot of workshops related to our products. We have PhDs, a project management group that helps in several promotional activities as well. They technically support us in terms of the application of the products. Since the last six months we have been working on our application support and logistics group, invested heavily in it, streamlining the process and working on a roadmap to be able to deliver the product to the customer in the shortest possible timeframe. We also are looking at providing training modules to our customers and providing bioservices to our customers who want to get more friendly with the technology using our platform. Majority of our instrumentation has already been arrived at and they have already started doing services for some of the sub components like real time PCR, bioanalyzer and we looking forward to providing microarray services in November. Shalini Gupta   ]]> <![CDATA["TERI-DBT Bollcure should be commercially released by 2008"]]> https://biospectrumindia.com/news/95/4243/teri-dbt-bollcure-should-be-commercially-released-by-2008.html https://biospectrumindia.com/news/95/4243/teri-dbt-bollcure-should-be-commercially-released-by-2008.html Thu, 04 Oct 2007 10:25:00 +0530 New Page 1 "TERI-DBT Bollcure should be commercially released by 2008" -Dr Nutan Kaushik, Fellow and Area Convenor, Plant Biotechnology Division, TERI Scientists at The Energy and Resources Institute (TERI), have developed a biopesticide against cotton bollworm in a breakthrough research after a period of almost 10 years. The product is expected to hit the market by next year. In conversation with Dr Nutan Kaushik, Fellow and Area Convenor, Plant Biotechnology (Environmental and Industrial Biotechnology Division) at TERI who led the efforts, BioSpectrum finds out more. How did you come up with the idea of developing a biopesticide against cotton? Cotton bollworm (Helicoverpa armigera) being polyphagous in nature is the major insect pest of many crop species. It attacks many economically important crops such as cotton, pigeonpea, chickpea, tomato and sunflower. It has a host range of more than 181 plant species. Currently, it is the most difficult species to control because it has developed resistance to most of the commercially available insecticides. Taking up the challenge for developing a biopesticide to tackle the problem of H. armigera infestation, TERI scientists began research in this area during the late 1990s with support from the DBT. Do you think biopesticides are more effective as compared to chemical pesticides? If yes, why? I would not say that the biopesticides are more effective as compared to chemical pesticides. With the problem of resistance, residue and resurgence with the injudicious use of chemical pesticides, we are now looking forward to the pest management strategies, which are less dependent on chemical insecticides and/or less conducive to the development of resistance to present chemical control measures. Biopesticides are an integral part of such pest management strategies. How does the pesticide work at destroying bollworm? How different is it from other chemical pesticides in the market against bollworm? It affects the growth of the bollworm larva resulting in reduction of larval weight up to 88 percent, hence restricting the larvae population, resulting in ultimate death of the larva itself, apart from its mild anti-feedancy thereby, preventing the crop damage. Since it is a plant extract of Eucalyptus, it is 100 percent environment friendly, suitable for conventional, organic, Bt cotton and integrated pest management crop practices. The product controls the bollworm complex of cotton. It is also effective against jassids, white fly, and spodoptera. How did you zero upon eucalyptus plant extract? After screening numerous plant species we found eucalyptus extract more effective than the other plant extracts tested for their effectiveness against cotton bollworm. What are the standards on which the pesticide has proved itself? What was the increase in crop yield in field trials after using the biopesticide? Chickpea results Drastic decrease in the population of H.armigera Mean number of larvae of Helicoverpa armigera decreased by 85.68 percent, 6 days after Bollcure application and 93.82 percent after 10 days as compared to the untreated chickpea crop. Tremendous decrease in the percent pod damage Bollcure treatment in the organic mode decreased the percent pod damage at maturity by 69.91 percent in comparison to the untreated chickpea crop. Tremendous increase in the crop yield Application of Bollcure increased the crop yield by 205.81 percent as compared to the untreated chickpea crop. Cotton results Drastic decrease in the percent incidence of Bollworm Bollcure application in the IPM mode decreased 40.13 percent incidence of bollworm in shed reproductives, 70.33 percent incidence in green bolls and 55.70 percent in open balls in the cotton crop. Tremendous increase in the total yield of the seed cotton Bollcure application in the IPM mode resulted in 132.72 percent increase in the yield of the cotton crop as compared to the untreated control crop. When is it set to be commercially released in the market? We have filed process and the product patent and have initiated the process for its registration. We are quite optimistic that TERI-DBT-Bollcure should be commercially released in the market by 2008.   Shalini Gupta   ]]> <![CDATA[Vaccine launches on the rise]]> https://biospectrumindia.com/news/95/2866/vaccine-launches-on-the-rise.html https://biospectrumindia.com/news/95/2866/vaccine-launches-on-the-rise.html Thu, 04 Oct 2007 10:24:00 +0530 New Page 1 Vaccine launches on the rise Indian companies have stepped up the introduction of indigenously developed vaccines. Advances in immunology and vaccinology have increased the hope that new vaccines will target other diseases such as cancers, immune system disorders, allergies and autoimmune diseases. A large number of vaccines under development prove to make the vaccines market an interesting and dynamic one over the next five years. There are currently more than 1,000 vaccines in research and development stage worldwide, and in the future, they are expected to be a cost-effective alternative to conventional treatment. Developing countries such as India, China, and Brazil with their significant innovative scientific capabilities and resources are likely to play a major role in contributing to the global R&D efforts in developing novel vaccines. Though most of the technologies are currently in the initial stages of development, they are excitingly close to reality. The development of new therapeutic vaccines targeting cancer and other life-threatening diseases is also sharpening the focus on this area of medicine, while driving greater investment in more advanced processing techniques. Dominant players in India include Shantha Biotechnics, Serum Institute of India, Bharat Biotech, Bharat Serums and Vaccines, Biological E, Indian Immunologicals and Panacea Biotec. Indian companies are looking at penetrating the European and American markets in the future and are producing products that adhere to international standards of good manufacturing and clinical standards. In August-September this year alone several major announcements have been made. Serum Institute of India Ltd, India's largest vaccine manufacturer, launched its indigenously manufactured low-cost Haemophilus influenza type b conjugate vaccine under the brand name of HibPRO in India. HibPRO has been priced at MRP Rs 375 for a monodose vial. HibPRO is considered to be a vaccine with clinically proven efficacy and safety at an affordable price. HibPRO has undergone a series of clinical trials to prove its efficacy and safety in comparison with commercially available Hib conjugate vaccines. With the launch of HibPRO, Serum can extend the benefits of pentavalent or quadravalent vaccines at a very affordable price. The benefits are mainly fewer numbers of injections, lesser pain to the child and protection against multiple diseases such as H. influenza type b, Hepatitis-B, Diphtheria, Pertussis and Tetanus in one injection. Serum Institute had launched Q-Vac, combination vaccine, and Td-Vac, tetanus and diptheria vaccine, in the year 2005-06. Serum Institute of India is one of the largest manufacturer of measles vaccine and DTP group of vaccines in the world. Panacea Biotec, the number three-ranked company, is the top oral polio vaccine supplier in the country. Biotechnology firm Bharat Biotech International (BBIL) has also launched BioHib, Haemophilus Influenza Type b (Hib) vaccine in India, and Comvac 4-HB, a tetravalent combination vaccine. Comvac4-HB and BioHib enable the deployment of a combination pentavalent vaccine in a single injection. BioHib too is a safe and affordable vaccine that offers complete protection against Hib Infection. BioHib is a conjugate vaccine that has proven its safety and efficacy in multi-centric clinical trials. According to Bharat Biotech officials, while other Indian manufacturers had imported conjugation and manufacturing technologies from Europe and the US, the scientific manufacturing and product development teams at Bharat Biotech have developed all processes required to manufacture BioHib in-house. The company had made huge investments in the last four years into its R&D capabilities and its manufacturing facilities to develop and manufacture BioHib vaccine. Haemophilus influenza type b (Hib) bacterium causes serious disease, often life-threatening illnesses in young children. Hib can cause meningitis and severe pneumonia, leading to about 3 million cases of serious illness and 4,00,000 deaths each year in children below five years of age. Hib is difficult to treat in the developing world, with infected children in developing countries several times worse than those in industrialized countries. Invasive disease can be treated with antibiotics but lack of access to adequate medical facilities and increasing levels of antibiotic resistance lead to a high mortality rate: 20 percent of children in developing countries with Hib meningitis will die (rising to an even higher percentage in Africa and Asia). About 15- 35 percent of children suffering from Hib meningitis will go on to develop life long disabilities such as mental retardation or hearing loss. Panacea Biotec, one of the largest vaccine producers in India, will rollout a Foot and Mouth Disease (FMD) vaccine in the coming 18-24 months. The company has collaborated with National Research Development Corporation (NRDC) for in-licensing of technology to produce and market the Foot and Mouth Disease (FMD) vaccine developed by Indian Veterinary Research Institute (IVRI). Panacea's entry into the animal vaccine segment will give additional width to its product portfolio. In fact, most of the companies in the vaccine arena do have a veterinary arm as an offshoot to the human vaccine segment. The FMD vaccine will be one of the products at Panacea's multi vaccine facility. Panacea Biotec recently inaugurated its greenfield construction vaccine formulation plant (VFP) at Baddi in Himachal Pradesh. The plant has been commissioned with several filling lines for bacterial and viral vaccines complying with WHO, cGMP norms for liquid vaccines in pre-filled syringes, liquid and lyophilized vaccines in vials. The total production capacity of this facility is one billion doses per annum. Panacea Biotec had entered joint ventures for vaccine manufacturing with Chiron Vaccines (Emeryville, CA) and thermostable vaccine production with Cambridge Biostability (Cambridge, UK). Panacea Biotec is also negotiating a collaboration with ApoLife (Detroit), for using ApoLife's yeast-based technology for the production of therapeutic humanized antibodies. Hyderabad-based biotech company, Shantha Biotechnics, in collaboration with the global nonprofit health organization PATH, is developing a multivalent vaccine against rotavirus. The technology has been licensed from the US National Institutes of Health (NIH). Shantha and PATH are working in partnership to accelerate the development of this new vaccine. There are two licensed vaccines for rotavirus, Merck's RotaTeq and GSK's Rotatrix, and both these vaccines are currently not available in India. Shantha carries the credit of developing and commercializing India's first recombinant Hepatitis-B vaccine and other combination vaccines with the DTP platform. Shantha's vaccines (Shanvac-B and Shantetra, DTP-Hepatitis B) are WHO pre-qualified and are supplied in various countries in Asia-Pacific, Africa, CIS and Latin America by the international agencies like UNICEF and PAHO. Biological E will be launching the Hib vaccine and the DPT + Hepatitis b combination vaccine in the next few weeks. It will be followed by the injectable polio vaccine and the pentavalent combination vaccine, Hib + DPT+ Hepatitis b which is under development. The company has also set up a new vaccine division - Origyne in the biotech park which would take care of the marketing. In addition, Biological E has recently signed an agreement with Merck under which Merck will be manufacturing its vaccines in the Shameerpet unit. A major portion of global research efforts is being directed towards developing DNA vaccines. While DNA vaccines for humans are still in preclinical development or in the early-stage clinical trials, they show immense potential for effectively targeting HIV, herpes, malaria, and influenza, meningitis and various types of cancer. Moreover, DNA vaccines have the ability to stimulate potent immune responses without the drawbacks of conventional vaccines. The greatest advantage is that they are noninfectious and can be used for producing vaccines against diseases such as HIV, where inoculation with a dead or attenuated virus is too risky. In addition, DNA vaccines are inherently stable and do not require constant refrigeration. These vaccines are expected to be particularly popular in developing countries since it is feasible to produce and purify large amounts using simple and inexpensive procedures. Rapid advances in biotechnology and immunology have been a constant driving force behind the development of vaccines. While a detailed understanding of immune responses has been applied to different stages of vaccine development, advances in biotechnology based on genomics, DNA platforms, and delivery systems offer significant opportunities for developing new vaccines and expanding the number of target diseases. Researchers are looking at proteins from genetically engineered plants to create edible vaccines. Although its commercial viability is yet to be proven, oral vaccination provides a cost-effective and convenient alternative to conventional vaccines. Moreover, an oral vaccine not only elicits a good immune response, it is also likely to eliminate the geographic limitations inherent in most vaccination programs. Therapeutic vaccines development is seeing an increasing trend towards the use of multiple antigens and adjuvants, to attack cancers or HIV from multiple angles. Combinations of therapies, and novel approaches such as prime-boost regimens are expected to yield exciting results. Partnerships will therefore become much more important. Therapeutic vaccine development is currently heavily weighted towards cancer vaccines, which account for 60.6 percent of all pipeline projects. However, the early-stage pipeline is starting to show greater interest in other therapeutic areas, from HIV and infectious disease, CNS and cardiovascular diseases. Challenges Policy challenges at the national level contribute to the delay in making new vaccines accessible to people. In India, the public health research is overburdened, underfunded, and poorly coordinated. Some of the key factors responsible for the current state of affairs include the absence of a directional consistency and lack of coordinated planning, limited infrastructure, inadequate funding, and insufficient interaction and collaboration with industry. Inadequate public funding to support R&D has a negative impact on both public and private sector efforts. In addition, venture capital funding is quite limited for health-related R&D. Vaccine R&D poses a number of risks to companies, which choose what they perceive as the best business opportunities. The vaccine business is expensive, risky and with a smaller market than pharmaceuticals. Marketing vaccines can be uncertain with significant risk. Demand for certain vaccines can be variable and unpredictable. Uncertain demand for vaccine is one obstacle, especially since much of the anticipated market is in developing countries, where the ability to pay for a vaccine is limited so the companies fear that they will not be able to charge commercially feasible prices. Indian biotech and pharmaceutical firms have strong product development capabilities but increasingly focus on export markets. Most leading Indian pharmaceutical and biotechnology firms earn more than half of their revenues from export markets. The many layers of regulatory approvals and inadequate funding result in inordinate delays and, ultimately, slow down the innovation process. Indian players perceive that any potential product would be country/region specific; given the different strains of virus across countries and regions, they are concerned that a vaccine developed in India would not be exportable to other countries and regions. However, India's high population makes it an important player in this industry and several domestic players are competing in this market. In India about 15 companies are involved in the marketing of over 50 different brands for 15 different vaccines. Clearly, there is a high competition on the price front and companies are launching newer vaccines into the market to increase their revenue. The largest markets for vaccines in India are for Tetanus Toxoid, polio, DPT, Typhoid, BCG, measles and Hepatitis B. Indian and international research organizations and agencies are developing vaccines for anthrax, HPV, HIV, typhoid, Japanese encephalitis, malaria, cholera, rotavirus, colitis, HIB meningitis and other diseases. It is becoming clear, however, that to make more significant progress in the future, some changes need to be implemented to the strategies applied in the past for vaccine development, safety checks, global distribution, and disease monitoring. The heterogeneous needs of different world areas, the emerging of specific problems in certain countries, the shifts in the world economic equilibrium, as well as several other factors all have to be taken into account to sustain as a leader in the vaccine business.   Jahanara Parveen with inputs from Shalini Gupta in New Delhi   ]]> <![CDATA[Thriving biotech entrepreneurs]]> https://biospectrumindia.com/news/95/2922/thriving-biotech-entrepreneurs.html https://biospectrumindia.com/news/95/2922/thriving-biotech-entrepreneurs.html Wed, 05 Sep 2007 10:56:00 +0530 New Page 1   Thriving biotech entrepreneurs Exactly a year ago, BioSpectrum highlighted the second wave of biotech entrepreneurship taking place in the country by profiling 20 of the most prominent new companies in two parts. A year later, it is time to do a reality check. That is what the BioSpectrum editorial team did in the last few weeks. The news is heartening. Most of the companies profiled in 2006 have made significant progress since then, some even charting out new pathways in their quest to find a place among the country's new crop of wealth creators. Each of them have tried to create their own niche. Some have focused on global opportunities, others have formed alliances, many have stuck to their targets and went after it with single-minded obsession. Some companies are scouting for acquisitions. Just a few examples. Navya Biologicals has moved to Dharwad from expensive Bangalore. RFCL has done a massive reorganization exercise to become a nimble institution. Biovel has set up an office in Atlanta and inked a licensing agreement with US-based Dowpharma to produce Human Growth Hormone (HGH) using Pfenex Expression Technology. Advinus Therapeutics is forging alliances with Veeda, Merck, Samaritan Pharma. Premas has achieved its revenue targets. Even more heartening is the trend that more entrepreneurship is taking place in the Indian biotech sector now. A few top global companies have set up operations in recent months. Few examples: R&D centers of DuPont, AMRI. One of the world's top biotech company, Biogen Idec has moved in quietly and is testing its waters out of an office based in Gurgaon, a New Delhi suburb. Over 15 new biotech start-ups which will make significant contributions to the industry in the next 4-5 years have been profiled in the September issue. Another issue that has been hanging fire for some time is the final version of the National Biotech Policy. More than 90 percent of the objectives set out in the draft policy have been implemented, according to Dr M K Bhan, who piloted the policy. Only the contours of the new regulatory mechanisms have to be charted out and the proposal is going through micro-evaluation at the Union cabinet level. An update on the major decisions implemented from the policy is available in this issue. An example of the policy haze lifting of the biotech sector is the regulatory approval given to the first-ever field trial of a genetically modified (GM) food crop, in this case a Bt brinjal from Monsanto Mahyco, in August. This will open the floodgates for the approval of trials of many more GM food products in the next few months. Policy makers have finally overcome the fear psychosis induced by a large group of vocal NGOs over the food safety issue. Over a dozen GM food crops developed in various publicly funded laboratories in the country are ready to seek regulatory approval. However, the major hurdle in their path is lack of resources to comply with the elaborate processes required by the regulator, the Genetic Engineering Approval Committee (GEAC) in the Ministry of Environment. It will cost approximately Rs 2 crore to complete the trials required for each product. As part of its mandate to promote biotechnology, the Department of Biotechnology (DBT) could consider financially assisting these research institutions to seek regulatory approvals. It would certainly enhance overall customer choice in GM products. August was a happening month for Indian biotech. The country's No.1 publicly funded biotech institution, the Rajiv Gandhi Center for Biotechnology (RGCB) in Thiruvananthapuram, has crossed a major hurdle in claiming its National Institution status. The Kerala government handed it over to the Union government in early August. RGCB director, Dr Radhakrishna Pillai has chalked out a major plan to make it one of the country's top biotech institution using the enhanced resources which will be available due to the new status.   <sureshn@cybermedia.co.in> ]]> <![CDATA["I see RGCB as a national research institute with a difference"]]> https://biospectrumindia.com/news/95/6679/i-see-rgcb-as-a-national-research-institute-with-a-difference.html https://biospectrumindia.com/news/95/6679/i-see-rgcb-as-a-national-research-institute-with-a-difference.html Tue, 04 Sep 2007 17:11:00 +0530 New Page 1 "I see RGCB as a national research institute with a difference" -Dr M Radhakrishna Pillai, director, RGCB The Rajiv Gandhi Center for Biotechnology (RGCB), Thiruvananthapuram, will now be a national autonomous center under the administrative control of the Department of Biotechnology (DBT), Government of India. This announcement came in the last week of July. It may be recalled, that following the Budget announcement in 2006, DBT had asked the state government (Kerala) to sign an MoU transferring the institute to it. However, with a new state government assuming office, it preferred to review the entire process. This unfortunately took 10 months. The matter was then placed before the state cabinet that passed formal orders in February 2007 to transfer the institute to Government of India. Following this, the Central government also decided to take a full Union Cabinet approval. This was done on July 26, 2007, with the effective takeover date as April 1, 2007. With this, the takeover decision is now fully implemented. The institute will now be a national autonomous center under the administrative control of the DBT. Kapil Sibal, the union minister for science and technology and earth sciences, will be the president of the institution. And a governing council headed by the secretary, DBT will oversee the administration of the institute. A scientific advisory committee will monitor and advice on research and development. RGCB is a state-of-the-art biotechnology institute, which is the only one in the country to focus on translational research. It is working on novel and highly potent drug leads and nutraceuticals and identification of genes and disease variants of significance to pharmacogenomics and molecular medicine as well to plant biodiversity and crop improvement. According to BioSpectrum's Top 20 Schools survey, published in January 2007, RGCB was the No.1 ranked biotech institute in India. With the current development, the institute now has the mandate to be one of the best biotech research centers in the world. In an exclusive interview to BioSpectrum, Dr M Radhakrishna Pillai, director, RGCB, explains the merits of this development and the plans of the institute. What would it mean for RGCB being accorded the status of an autonomous institute under the administrative control of DBT? The union minister for science and technology and earth sciences, Kapil Sibal, very aptly summarized the implications of RGCB becoming a national institute. Speaking to the media after formally announcing the Union Cabinet's decision of taking over RGCB by Government of India, he said, "RGCB is an institute that has been doing very well nationally. We will now take this center to international levels." I confess to being a dreamer. I came to RGCB in March 2005 with a dream of converting it to a national center. Showcasing our institute and its potential to the Department of Biotechnology, minister of science and technology and the prime minister, we accomplished this achievement in less than a year. The Union Budget 2006 announced RGCB being made a national autonomous research institution. The calculations of the Indian government were proved correct when BioSpectrum after a national survey ranked RGCB as India's best biotechnology school. I now have no limits to the dreams and plans for RGCB. I would like it to be different from other similar institutions. Our strength is in the wealth of knowledge bases that we have in biological and chemical sciences. Kerala is best known for its excellent knowledge wealth, but has been unable to translate this into commercial rewards. What we would like to do is to really bridge this gap by really doing what we do best--translating our biotech knowledge into health care requirements and better quality medicinal plants, nutraceuticals and spices. What is your vision for RGCB? I envision RGCB as an institute with two components as part of the 2020 strategy. One, a state-of-the-art research center nestled close to India's greatest biodiversity resources in the Western Ghats and located in the center of an ecologically balanced biotech park. Here we will translate our drug development program in close association with biotech and bio-pharma units located around the research center. We will use our genetic engineering and molecular medicine knowledge to transform and improve medicinal plants, nutraceuticals and spices, all so prevalent in this biodiversity zone. The other component would be to convert our present campus into a unique teaching and training center in applied biotechnology. I foresee state-of-the-art academic courses and programs specifically catering to the new industries of healthcare, hospitals, CROs, biotech and biopharma companies. These would include Master's level courses in clinical biotechnology, molecular medicine and systems biology as well as management degrees in biotechnology. In addition, we see ourselves as a major training center for the huge number of BTech and MSc Biotechnology graduates who come out every year with poor foundations in molecular and clinical biology. What would be the mandate for RGCB now? Our mandate is to conduct interdisciplinary collaborative research with industry and clinical centers in translational research aimed at the rapid translation of scientific discoveries from our lab to the benefit of society. RGCB's expertise in the areas of cancer research, pharmocogenetics, protein engineering, molecular reproduction, infectious diseases, neuro and stem cell biology and plant genetic engineering biology will be integrated for achievement of this main goal. This achievement is also expected to promote the growth of biotech industries in Kerala. We have as our major objective a National Drug Development Center working based on the extensive traditional Indian medicine practice and the extensive biodiversity resources available in Kerala. We will use these two sources in combination with modern biology, bioprospecting with a matrix of systems and computational biology to develop this unique drug development program. Our research to date has given us sound models for analyzing bioactive compounds including transgenic cell lines, in vitro models for neuron damage, tumor stem cells and hepatitis C besides numerous targets in cancer and tuberculosis. These will be the base on which we will take our drug development to high throughput automated levels. Our expertise in genetic engineering has brought us enquiries on taking up joint ventures in plant biotechnology. We have been approached by NABARD for improving the output of biofuel from jatropha and from Kannan Devan Tea Plantations for genetically improved varieties of tea. In addition, we are providing a master plan to the commerce ministry for a comprehensive program on disease resistant ginger and pepper, two of Kerala's primary cash crops. We have already begun efforts to express major recombinant human therapeutic proteins in plants with a view of mass production at low costs. In addition we see a social relevance in this--both by bringing down costs of these expensive proteins and rehabilitating the tobacco farmer in view of strong national and international pressures on the tobacco industry. These programs in genetic engineering will be a major function of RGCB in the months to come. We will also promote high quality biotechnology education at postgraduate, doctoral and postdoctoral level and act as a nodal contract research centre for carrying forward research leads in bioprospecting and drug screening from pharmaceutical industries and R& D centers. What are some of the key developments you foresee at RGCB now that it is placed as a national institution? At present there are six national biotechnology institutes in India. RGCB will be the seventh and the first in Kerala. The annual core budget will rise from the present Rs 8 crore per year to at least Rs 20-25 crore per year. We can attract direct participation of national and international agencies in research and development programs. And this will also allow clusters of biotechnology industries around RGCB. History shows that this is the only way to attract and develop biotechnology-based industry. The Centre in Union Budget 2006 announced to grant RGCB the autonomous institute. Did you receive any grants from the Center following that announcement? Will a budget of Rs 100 crore be sufficient? Since the effective take over date is from April 1, 2007, funds will be released by DBT from that date. We therefore underwent tremendous hardship in 2006-07 with only a lifeline support from the state. With the large extramural support and savings (income) the institute got from training students and providing DNA fingerprinting services to judicial and crime investigating agencies and molecular diagnostic services, we managed to break even. It's a process that I hope the institute will never have to go through again. I fully realize that the Rs 100 crore allocated for us in this five-year plan is not going to get us any of these dreams. But I am fully confident of convincing the right financial sources--government, private and venture capital that we have this knack of delivering on what we promise. Two years ago, we were a little known state institute located in a southern corner of the country. We are today the most talked about institute. I have full faith in our primary assets--the scientists, technical personnel and students. We will deliver. What are the major achievements of RGCB till date? Investigators at the Regional Cancer Centre and Rajiv Gandhi Centre for Biotechnology in Thiruvananthapuram have developed an anti-inflammatory and anti-microbial mouthwash consisting of three commonly used medicinal herbs for controlling radiation associated mucositis (painful swelling of the gums and cheek) in patients being treated with radiation therapy for oral cancer. We have made significant progress in the area of bioprospecting, target identification and assay development in the drug discovery process against infectious diseases, reproductive disorders, cancer and neurological ailments. We has also developed diagnostic techniques for infectious diseases such as dengue fever, Chikungunya, HCV, cholera and Mycobacterium tuberculosis, DNA fingerprinting based diagnostics including HLA typing. Further, protocols for value addition to medicinal plants like Baccopa monniera (Brahmi) and Andrographis paniculata have also been developed successfully. We also established facilities for molecular diagnostics and DNA finger printing to cater to social and criminal justice systems as well as diagnostic and health needs of the society as a spin-off of the research activities of RGCB, besides developing novel cell based assays for screening compounds s for anticancer, antiviral and neuroprotective activities. What are some of the breakthroughs that you expect in the future? Some of them would include: Marketable, ultra sensitive diagnostic kits for Dengue fever, Chikungunya and Tuberculosis. High-throughput cell-based screening assays for target based drug screening for cancer, viral diseases and neurological diseases. Stem cell-based therapy for chronic diseases and tumor stem cell based screening systems for anti-cancer drug design. Identification of novel biomarkers for disease predisposition, stress tolerance, drug sensitivity, etc. in humans and plants. What is the current staff and student strength? We have 28 full time staff scientists, 14 well-trained technical officers, five bioinstrumentation/electrical engineers, 10 skilled technical assistants, a small compact and efficient administration of 12 and remaining 13 support staff. Our student strength currently exceeds 100, including PhD students, project fellows, and research assistants. This is really the "mind and body; heart and soul" of RGCB (with due acknowledgement to VISA for lifting their slogan) Can you briefly tell us about the infrastructure and other facilities available at RGCB? We currently have over 1,50,000 sft of prime laboratory space. The institute has all state-of-the-art equipment for modern biology research including flow cytometers, real time PCRs, MALDI TOF, Protein sequencer and synthesizer, 46 capillary DNA sequencer, electron microscope, confocal microscope, HPLCs, GC-MS, Pulse field gel systems besides all routine molecular biology equipment. The institute also has a start-up animal research facility and transgenic green house. RGCB has an excellent on campus accommodation for its students and a state of the art convention center seating 300. How closely do you work with the industry and how many products or technologies are seeing commercialization? RGCB has been the attraction of several industries for the validation and evaluation of their products both from India and abroad. We are in negotiation as to the further development and processing of our unique mouthwash described earlier. Currently several bioactive compounds are undergoing their functional evaluation at various laboratories of RGCB. These include Mediscien (bioactive peptide development and evaluation); Strides-Arco (human growth hormone functional evaluation); and Treeland (monoclonal antibody production). A major long-term initiative with Hindustan Latex Limited for vaccines and diagnostics is being jointly prepared. Discussions are on to transfer some of the patented technologies from RGCB for commercial applications. An incubation facility will be established at RGCB to cater to the needs of biotechnology industries. Infrastructural and technical expertise of RGCB will be made available to both established and small or start-up industries to enable them to become more competitive in the generation of biotechnology based products and process. How would you rate RGCB on the international scale? BioSpectrum ranked RGCB as India's top biotech institute this year. How different are you compared to other universities or institutes like IISc or JNU in India or globally? In addition to the vision plans I have answered in the previous questions, I see RGCB as a national research institute with a difference. This is why we are so highly regarded. We have a number of leading advantages that may not still be known to researchers, prospective collaborators, career seeking students, postdoctoral trainees, pharma companies and biotech industry. To put it into a nutshell, RGCB has a vibrant research atmosphere, loyal, dedicated and talented personnel, energetic and excellent infrastructure, efficient corporate culture in R&D administration, encourages industry partnerships, excellent track record in project implementation and obtaining extramural funding, well sought after and comprehensive PhD program in biotechnology, and leadership in contract research, among other things. Ch.Srinivas Rao   ]]> <![CDATA[Taiwan broadens its biotech horizon]]> https://biospectrumindia.com/news/95/2372/taiwan-broadens-its-biotech-horizon.html https://biospectrumindia.com/news/95/2372/taiwan-broadens-its-biotech-horizon.html Tue, 04 Sep 2007 17:07:00 +0530 New Page 1 Taiwan broadens its biotech horizon July is Taiwan's biotech month. The consensus on the statement is the result of efforts of Taiwan Bio Industry Organization, which has been successfully organizing BioTaiwan for the last four years. The four-day international exhibition attracted business visitors from India, Malaysia, Australia, Japan, China and US among other countries Continuing the tradition of hosting "the biotech exhibition in the Asia Pacific region" and showcasing the developments in Taiwanese biotechnology industry, Taiwan Bio Industry Organization organized the fifth edition of the event BioTaiwan 2007 at Taipei World Trade Center. Government organizations and institutions like Science & Technology Advisory Group, Industrial Development Bureau, Ministry of Economic Affairs, Biotechnology and Pharmaceutical Industries Program Office, Ministry of Economic Affairs, Industrial Technology Research Institute, have joined hands with the associations like Kaohsiung Biotechnology Association, Chingâ€“Kang Foundation for Pharmacy Promotion to support Taiwan Bio Industry Organization in organizing BioTaiwan 2007. This four-day international exhibition attracted business visitors from India, Malaysia, Australia, Japan, China, USA and other countries. The idea behind organizing Bio Taiwan-an annual event held during July-is to increase public awareness and interest in biotechnology, build biotech concepts in younger generation, and encourage them to get involved in biotechnology. At the same time, it introduces local biotech industry to overseas state-of-the-art biotech R&D projects and venture capital firms and helps foster co-operation between countries. Though the exhibition divided into various segments does not attract many of Taiwan's significant 'real' biotechnology companies a good number of healthcare, nutritional, cosmetic and herbal medicine companies were spotted at the event. The universities from Taiwan having biotechnology and life sciences divisions, and incubation centers were seen showcasing the courses on offer. The exhibition attracted students, consumers and professionals. According to organizers, the 2007 edition has attracted tens and thousands of visitors to over 800 booths. Talking about the exhibition, Mr Andy Ladwig, Managing Director, E2joy, an equipment solutions provider for laboratories, life sciences and pharmaceutical companies in Taiwan said, "Taiwan is witnessing lot of activities in biotechnology, basic research, and CRO space. This exhibition provides a platform to share and exhibit the latest developments happening in Taiwan." The event had parallel sessions on different topics including symposium on multinational trials in the Asia Pacific region, innovation & regulations for pharmaceutical combination products, biotech investment opportunities, niche market and scientific research of phytomedicine and supplements, cutting edge biomedical technologies in anti-aging and aesthetic medicine, theory of GTP labs construction and maintenance. The symposiums were more in local languages so that the local industry could benefit. Narayan Kulkarni in Taipei   ]]> <![CDATA[Taiwan to develop $900 mn biotech park]]> https://biospectrumindia.com/news/95/1362/taiwan-to-develop-900-mn-biotech-park.html https://biospectrumindia.com/news/95/1362/taiwan-to-develop-900-mn-biotech-park.html Tue, 04 Sep 2007 17:03:00 +0530 New Page 1 Taiwan to develop $900 mn biotech park The government in Taiwan is keen to establish biotech parks with unique features. "Our vision is to create a National Biotechnology Park with a total investment up to $900 million in the building of the park. The Ministry of National Defense will make 25 hectares of its property at the Military 202 Armament Factory in Nankang available for the establishment of a biotech science park," said Mr Chen Shui-bian, President of Taiwan. Delivering the key note address at the two-day "BioBusiness Asia 2007" summit at Taipei, the President said, "The National Science Council will invest $400 million to plan the layout for the park's biomedical compound, and will be in charge of the construction of the park's basic infrastructure and education center. At the same time, the Academia Sinica, on its part, will invest around $500 million to build the park's research and development center and clinical laboratories, and introduce research on new pharmaceuticals and special biotech disciplines, such as translational medicine and genomic medicine." Urging the international community to support Taiwan's efforts to participate in the World Health Organization (WHO), the President further pointed out that besides the National Biotechnology Park, "We are planning to build two more communities of leading biotech enterprises. One of these will be located in the Hsinchu Biomedical Science Park, and will aim to attract major biotech companies, vaccine manufacturers, pharmaceutical companies, electronic and telecommunications-based medical equipment manufacturers, and animal laboratories to open operations there. The other community will be located in the Kaohsiung Science Park, which is part of the Southern Taiwan Science Park. It will focus on attracting manufacturers of dental and orthopedic equipment, scalpels, and microelectromechanical systems. We believe that only with these three communities of biotech enterprises in place can we lay a solid foundation for the development of Taiwan's biotech sector, so that Taiwan can become a visible player in the global biotech industry." He also observed, that the government and private sector's efforts in promoting the biotech sector have led investment in the biopharmaceutical industry to increase from less than $300 million-a-year to nearly $700 million-per-year over the past five years. By the end of last year, the number of biotech and biomedical companies in Taiwan exceeded 1,100. These companies had a total business turnover of $6 billion last year and enjoyed an average annual growth rate of 13 percent over the past five years. Development in this sector is indeed gathering speed.   ]]> <![CDATA[Harnessing desiccant tech for inhalation therapies]]> https://biospectrumindia.com/news/95/1725/harnessing-desiccant-tech-for-inhalation-therapies.html https://biospectrumindia.com/news/95/1725/harnessing-desiccant-tech-for-inhalation-therapies.html Tue, 04 Sep 2007 16:59:00 +0530 New Page 1 Harnessing desiccant tech for inhalation therapies Active packaging components are today a critical consideration for creating a successful dry powder inhaler system. Exubera-the first inhaled form of insulin for treatment of diabetes-made headlines when it received FDA approval earlier this year because it promises to free diabetics from the discomfort and intrusiveness of mealtime injections. This new drug joins a growing suite of pharmaceuticals that are being packaged in fine powder form for use in inhalation devices. For clinicians and patients, respiratory drug delivery offers several advantages over conventional delivery methods, including precise dosing, speed of action, and convenience. To succeed in the emerging market for inhalation therapies, pharmaceutical manufacturers need to understand the design and production challenges unique to this form of drug delivery. Active packaging components are a critical consideration for creating a successful dry powder inhaler (DPI) system, especially the role of sorbents for regulating moisture levels inside a DPI. Sorbents facilitate the smooth flow of drug particles and ensure that the device works, accurately, throughout its life cycle. The choice of sorbents, however, and their incorporation into a package or delivery device requires careful consideration to ensure effectiveness. Understanding the market The demand for inhalation therapies is fuelled by several factors, including new clinical applications and the growth of chronic conditions. Delivering drugs through the lungs is faster than oral delivery and can offer more controlled dosing, thus avoiding or minimizing most systemic side effects. Inhalation therapies are commonly used for treatment of asthma or chronic obstructive pulmonary disease-the world's fourth-greatest cause of death. However, inhalation therapies have begun to be used with biologics, which have typically been administered intravenously or through injection. Inhalation therapies are also being deployed for pain management, in which speed and ease of delivery are paramount. Because inhalation therapies offer a relatively painless, convenient mode of drug delivery, industry experts note that they could increase patient compliance with recommended treatment-a particularly important consideration for management of chronic conditions. By improving compliance and providing more accurate dosing, DPIs have the potential to increase the efficacy and cost-effectiveness of drug treatments Going with the flow New inhalation therapies are made possible through the creation of novel delivery systems. There are a variety of DPI models, which manufacturers often customize to meet the needs of a particular product or patient population. Some DPIs include pre-measured doses of medicine in blisters, capsules, or other cavities that are inserted into the device before use. Once a patient uses all the doses, they discard the device. By contrast, "reservoir" devices offer continued use from a drug reservoir until the reservoir is depleted. They include an internal supply of a drug, which is measured and dispensed in the device itself. Sorbent technologies are an important component of any DPI system. Not only do sorbents preserve the potency and stability of drug formulations, but they also maintain air flow dispersion, ensuring accurate dosing. Like other pharmaceuticals, powdered drugs are subject to physical and chemical degradation. If moisture builds up inside a device, drug particles tend to agglomerate-making them too large to be inhaled or leaving some amount stuck to the device walls. Drug particle agglomeration can reduce the ability of the dry powder to flow through the system and affect the accuracy of dosage. In addition, excess moisture can cause changes in the potency or stability of powdered drugs by increasing their molecular mobility and fostering chemical degradation. Advantage of new desiccant technology Because proper desiccation is an integral part of DPI device functioning, the choice of sorbent is crucial. Today's sorbents are often described as "active packaging components" because they respond to changes in the headspace of packaging relative to outside conditions. In this way, they regulate humidity levels within a DPI device without making contact with the dry powder and optimize conditions for drug delivery. A new generation of desiccants-coated solid format (CSF) sorbents-is particularly well suited for DPI applications because they significantly increase the level of functional desiccation per unit volume. Through condensed density technology, CSF sorbents are able to deliver twice the moisture protection in the same dimensional space as a typical loose-fill desiccant. CSF sorbents can be made from silica gel, activated carbon, or a combination of both. To facilitate ease of use, manufacturers are designing inhaler devices in discreet forms, along the lines of lipstick cases or eyeglass holders. CSF sorbents can easily integrate into DPI designs because they can be manufactured into a variety of shapes and sizes. If there is an available cavity inside a particular DPI device, a CSF sorbent can be customized to fit inside of it, creating an "onboard" solution for pharmaceutical preservation. If there is no available space within the inhalation device itself, CSF sorbents can be produced in strip format and packaged alongside a DPI. Fine-tuning the desiccation process Finding the right level of desiccation for powdered drugs, however, can be tricky. While excess moisture can degrade drugs, over-desiccating can change electrical charges, generating static electricity that interferes with the dispersion of drug particles or denaturing biologically active molecules. Determining the correct desiccation formula should be part of an overall DPI design, in which, user-control, air-flow, static-electricity, and moisture play interdependent roles. When evaluating the desiccation requirements for inhalation devices, pharmaceutical manufacturers should consider the interactions between drug formulation, de vice, and packaging. They must also consider all of the sources of moisture, including the plastic from which a device is manufactured and any inserts or other components of the package. Sorbent producers should be able to provide expert advice to manufacturers during the design, production, and approval processes. Finding the right solution Respiratory drug delivery is a significant new trend, offering clinical benefits, dosage control, and patient convenience. Integrating sorbent technologies into dry powder inhalation devices will preserve the quality and safety of pharmaceutical formulations and ensure that the device functions accurately and effectively each time it is used. Adrian Possumato is global manager-pharmaceutical market, Multisorb Technologies (Buffalo, NY), North America's largest producer of packaged and fabricated sorbents and the world leader in active packaging components. He works closely with drug innovators and generic pharmaceutical manufacturers in their R&D, quality, regulatory, engineering, and manufacturing departments to determine the best selection of packaged sorbents to stabilize pharmaceutical formulations. He has over 15 years of experience in the pharmaceutical and chemical industries.   ]]> <![CDATA["We have become a one-stop shop for life sciences researchers"]]> https://biospectrumindia.com/news/95/2769/we-have-become-a-one-stop-shop-for-life-sciences-researchers.html https://biospectrumindia.com/news/95/2769/we-have-become-a-one-stop-shop-for-life-sciences-researchers.html Tue, 04 Sep 2007 16:52:00 +0530 New Page 1 "We have become a one-stop shop for life sciences researchers" â€“Sudhir Kant, president, Millipore India In January 2005, Dr Martin Madaus joined Millipore as its new global chairman, CEO and president. With him came a new leadership, a new strategy, and direction. The question in Dr Madaus' mind was how to make Millipore a $2 billion company by 2010. This thought ignited a quiet, but a major shift in strategy and transformation of Millipore. Prior to his taking over as the new CEO, for several decades, Millipore was mostly focused on filtration technology. Further, it used to hive off its business units as soon as it neared the $1- billion mark. In 1994, Millipore divested its Waters Chromatography division and focused on its membrane business. It hived off its microelectronics business (Mykrolis) in 2001 and refocused exclusively on its biosciences business. Millipore is now a changed company, focused on the life science markets. Its strategy is to acquire or create innovative new technologies that help improve customers' productivity in laboratory research and in biopharmaceutical manufacturing. During the next few years, Millipore expects to substantially increase its revenues by broadening its product offering through internal R&D, acquisitions and alliances. In 2005, it kick started this strategy by acquiring Swedish company NovAseptic AB and MicroSafe BV. In 2006, Millipore acquired Newport Biosystems and Serologicals. While its new direction emphasizes on revenue growth, it has taken decisive steps to streamline its manufacturing plants and improve the efficiency of its global supply chain. It reorganized the R&D organizations in both its bioscience and bioprocess divisions, brought in new leadership, and established a technology scouting group. In July 2006, Millipore bought Serologicals, which was a $300 million company, as part of its strategy to focus in the life sciences market. Millipore was about $950 million prior to that acquisition. It has become a $1.3 billion company in 2006. The mindset of Millipore is changing, not just globally, but also in India. Sudhir Kant, president, Millipore India, tells BioSpectrum, the progress of Millipore in India following the global change. How is your current business organized? We started earlier with two divisions--BioProcess and Bioscience. And today we have created strategic business units under these two main divisions. Till the Serologicals acquisition, the Bioscience division was providing filtration products. The Serologicals transaction has widened our capabilities and is making our Bioscience division more competitive. Serologicals was a combination of various companies with several technologies. The group comprised companies like Upstate, Chemicon, LINCO, and Celliance. It was acquired for $1.4 billion. And this gave us 6,000 licenses and almost a product is being released every week. The Bioscience division has now been structured around four key business units, providing total solutions. The Laboratory Water unit caters to a complete range of point-of-use laboratory water purification systems that remove contaminants and ensure water purity for laboratory researchers. The Biotools unit is focused on a broad range of high-quality products that separate, isolate, and purify biological samples in order to ensure the integrity of scientific experiments. The Research Reagents unit supports the life science researchers by providing antibodies and reagents that help identify and measure cellular interactions and functions. The Drug Discovery unit offers products and services that enable biotechnology and pharmaceutical companies to evaluate drug candidates. We have the largest facility worldwide for polyclonal antibodies--production, testing purification and conjugation. In fact, seven out of 10 monoclonal antibody manufacturers depend on Millipore. What are the current products and services that you are offering? The biggest advantage that we have is that Chemicon and Upstate brands are very well known in the industry. And with Millipore's international presence it made a perfect synergy with this acquisition. We have over 15,000 products and over 6,100 employees globally. This is one of the strongest portfolios in the area of life sciences. Our expertise is in areas of neurosciences, oncology, metabolic diseases, stem cells, and signal transitions. A lot of research is happening for reference testimony. We have a variety of cell culture products, including highly purified proteins and tissue culture media components, used primarily by biopharmaceutical and biotechnology companies as nutrient additives in cell culture media. Through Chemicon, we offer specialty reagents, kits, antibodies and molecular biology tools. It is a leading supplier of monoclonal antibodies, conjugates, antibody blends and molecular and cell biology-based detection kits for use in diagnostic laboratories. We have a drug discovery services division that functions like a contract research organization, besides selling a broad range of research products, including specialty reagents, kits, antibodies and molecular biology tools. This division is focused in areas like kinases, GPCRs, and ion- channels. This portfolio mainly came from Upstate, which is one of the leading providers of drug discovery services targeting kinase biology-based drugs. We also offer ion-channel drug screening services, which is an important tool for detecting potentially toxic side effects in therapeutic compounds. We also have a regulatory compliant lab for people interested in doing work on biomarkers and circulating proteins. This strength comes from LINCO, which is a leading developer of immunoassays for simultaneous multi-analyte detection and for identification of proteins. The company also sells kits that include cytokine/chemokine panels (human, rat and mouse) and endocrine panels (human, rat and mouse) that target metabolic diseases, such as diabetes, obesity and cardiac diseases. We provide bioanalytical, clinical trials and custom assay development services. On the Chemicon side, we also provide custom antibody development and production for both polyclones and monoclones. We have the gold standard reagents. We are already making the lab water, filtration tools etc. and with the new line of products we have become a one-stop shop for the life sciences researchers. In India, we are also doing the validation part under the BioProcess division, which has four key business units--filtration and chromatography; advanced manufacturing solutions like disposable manufacturing components; process monitoring tools; and bioproducts and technologies. How big is your Serologicals team and business in India? It is al most a new business in India. We have spent about nine months in training and setting up the infrastructure. And we would be increasing the business by differentiating through training the customer, understanding the customers and their applications, and handholding. We have four technical service people, four PhDs, one in sales and marketing and application specialists. However, the total bioscience team would be close to 80 personnel. We are the largest team across the industry in India. Researchers in India will benefit from the large services team that we have in six offices across the country. We have an application team and a technology team. We have also spaced the technology team across the cities to be close to the customers, which mostly comprises of PhD holders. The biggest change that customers will see today with Millipore's approach is application guides. That will help the customer get what he wants. We have already test marketed two guides, one for immunodetection and the other for cell biology and this has helped the researchers. Our website is also oriented towards encouraging scientists understand the applications. This is very different from a catalogue approach. Ch. Srinivas Rao   ]]> <![CDATA["3M plans to launch application development and filter validation services in India"]]> https://biospectrumindia.com/news/95/4455/3m-plans-to-launch-application-development-and-filter-validation-services-in-india.html https://biospectrumindia.com/news/95/4455/3m-plans-to-launch-application-development-and-filter-validation-services-in-india.html Tue, 04 Sep 2007 16:48:00 +0530 New Page 1 "3M plans to launch application development and filter validation services in India" -Cyril M D'Souza, general manager, Cuno Filtration Business, 3M Electro & Communication India Pvt Ltd On August 1, 2005, 3M acquired Cuno, a leader in filtration products for the separation, clarification, and purification of fluids and gasses. This acquisition was to leverage the strength of 3M in advanced materials innovation with Cuno's strengths on separation and filtration. Post acquisition, 3M-Cuno has strengthened its leadership position in the market by extensive market coverage and new product launches. 3M-Cuno is associated with most of the vaccine, therapeutic, and monoclonal antibody manufacturers in the country. Cyril M D'Souza, who is responsible for the Cuno Business in India, and has over 15 years of experience in the filtration business, played a pivotal role in the smooth integration of Cuno India business with 3M India. Under his leadership, the Cuno division has adopted the Six Sigma methodology, which is followed by 3M, and launched several new products. 3M is also setting up a state-of- the art process development and filter validation services laboratory to cater the process development and validation services requirement from the biopharmaceutical customers. Cyril D'Souza shares with BioSpectrum the divisions plans and goals. 3M is a global technology company. What are its key business units in India and how are the businesses structured here? 3M is fundamentally a technology-driven company. We produce thousands of imaginative products, and we are a leader in several market segments--from health care and highway safety to office products and optical films for LCD displays. Our success begins with our ability to apply our technologies, often in combination, to an endless array of real-world customer needs. Of course, the people of 3M and their singular commitment to make life easier and better for people around the world make all of this possible. 3M India has manufacturing facilities in Bangalore, Pondicherry and Ahmedabad and employs over 700 people. In 2006, 3M India had a turnover of Rs 510.3 crore with profits of over Rs 50.42 crore. Over the past years, 3M India has built an exhaustive list of satisfied customers and a reputation for unmatched quality with over 2,000 diverse products serving a number of markets like industrial, transportation, electro and communications, healthcare, display, graphics and safety, protection, security and construction, consumer and office, and fluid purification. 3M acquired Cuno, a leading player in the separation and filtration business, in 2005. How has this acquisition transformed 3M? 3M and Cuno expect to take advantage of Cuno's expertise in liquid filtration and 3M's complementary capabilities in air filtration, along with its broad presence in markets where demand for filtration solutions is growing, to serve customers around the world more effectively. 3M has strengthened its core technology of filtration, separation and purification, by acquiring Cuno. Cuno can leverage the traditional 3M sales and distribution network in the biopharmaceutical industry for promoting Cuno products and vice versa. What are 3M's focus areas in the life sciences and healthcare sectors--specifically in Asia and India? "Filtration, separation and purification" is one of 3M's core technology, apart from its medical and dental technology related to life sciences and healthcare. Cuno is a world leader in the design, manufacture, and marketing of a comprehensive line of filtration products for the separation, clarification, and purification of liquids and gases. 3M with its wide range of filtration products is closely working with the biotechnology, pharmaceutical and food and beverage customers catering to their filtration requirements. In India, Cuno is geared up to consolidate its leadership position in filtration by various programs like new product launches, building healthcare organization, customer prioritization programs with Six Sigma methodology, extensive promotional campaigns and by offering customized services to its customers. What are 3M's India plans in the healthcare and life sciences side? 3M conducted a comprehensive portfolio-planning workshop for Cuno business with its senior India and APAC leadership team last year. The team identified opportunities where Cuno can serve its customers better in India. The leadership team is excited about the opportunities in the growing biopharmaceutical market in India and wants the team to take new opportunities and challenges in this segment. As part of the plan Cuno shall enhance its operation by means of investments in manufacturing, services and strengthen the Cuno organization. What are some of the key products that 3M has introduced in India for the life sciences and biotech companies? What do you estimate the size of your products in India to be and how do you see competition in India? Zeta Plus range of positively charged depth filters is traditionally being used by the major vaccine manufacturers India. The new Zeta Plus EXT Maximiser with ZA media is excellent for cell clarification application for biotherapeutic products and can easily replace tangential flow filtration (TFF) systems for clarification applications. Cuno BioASSURE PES sterilizing grade membrane filters have shown better performance in terms of filter life and quality of filtrate compared to any other competitor's product. The superior performance is attributed to Cuno's patented technology of Advanced Pleat Technology (APT). The pleats are designed in a way that the effective filtration area is increased and region near the core of the filter is more open compared to the conventional pleat design. The customer's benefit from this technology includes longer service life of filter due to increased area and less pressure drop, which eventually boils down to effective cost of filtration. What are some of the new products that you plan to introduce for the biotech sector in India and when are they likely to be launched? We plan to launch Zeta Plus EXT Maximiser with SP media, "Generation 2" housings and high-end hardware systems for the biopharmaceutical manufacturing applications immediately. The other major launches include the application development service and filter validation services and large-scale disposable capsule filters (Biocaps) with Zeta Plus media in the near future. What are your distribution, sales, and technology support strategy in India? We have well-established sales team in all regions with local distributors in specific regions. Microfilt India Pvt Ltd (MIPL) is our channel partner in western India. Cuno has a full-fledged technical wing called the Scientific Application and Support Services (SASS) which works with our customers to optimize their processes. Currently the SASS personnel conduct feasibility and process development trials. Ch. Srinivas Rao   ]]> <![CDATA[DBT makes headway with biotech policy]]> https://biospectrumindia.com/news/95/5249/dbt-makes-headway-with-biotech-policy.html https://biospectrumindia.com/news/95/5249/dbt-makes-headway-with-biotech-policy.html Tue, 04 Sep 2007 16:39:00 +0530 New Page 1 DBT makes headway with biotech policy Though India does not have a National Biotech Policy in place, several concerns have been addressed and things are being streamlined. National BT Policy: Some implementations DBT is supporting seven centers of excellence. To promote quality human resource, Star colleges are being established and teaching training program has been initiated. The Small Business Innovation Research Initiative (SBIRI), which is aimed to support R&D innovation, has supported 16 proposals. To promote large partnerships, DBT has supported a major initiative between UDSC and Mahyco. The stem cell strategy mission program has also been initiated. The National Biotech Regulatory Authority proposal has also been proposed for the cabinet approval.   The National Biotechnology Development Strategy was formulated after extensive national and global consultations. But the policy is not yet there. The strategy document, which received over 300 comments from the NGOs, industry, and various other stakeholders, is now with the cabinet and awaiting the cabinet's approval. Though the document is waiting for the cabinet clearance, the Department of Biotechnology (DBT) has implemented several of the key recommendations. Prof. C Kameswara Rao, founder, Foundation for Biotechnology Awareness and Education (FBAE), who was on some of the committees, discussing the policy observed, "A policy should be promoting, controlling and unrestrictive. A policy cannot be closed even for a moment. You don't expect a final policy. It has to be reviewed, changed periodically and continuously updated." DBT has made a policy document almost two years ago, posted that on its website and asked for comments. "There were two task committees, one headed by Prof. MS Swaminathan for agricultural products and the other by Dr Mashelkar for pharma products. There are five different ministries involved here and they have conflicting trust. The major issue now is the biotechnology regulatory authority. There was one committee that was formed and some propositions were made. The person who was in-charge went on leave for sometime. So things are going slow. When you get around all the ministries, we will have a massive biotechnology regulatory authority, which is supposed to be a statutory and autonomous, not attached to any ministry," added Prof. Rao. There are some parts of the national biotech policy that are already in the process of implementation. However, Prof. Rao is eagerly waiting for the national council for biotech education and training, which is supposed to function like the military council, dental council, or Bar Council. Four centers have been identified--one in Bangalore, one in TERI, New Delhi and one is in Baroda, and the fourth one will possibly be in Kolkata. These four centers are expected to be upgraded to the levels of institutes at the international level. Dr Shama Bhat, Bhat Biotech, Bangalore highlighted that something still has to be done on the Duties. "You can import an HIV kit (diagnostic) today from China, Korea or USA without paying duty, but if you want to import raw materials, you have to pay duty. The government is discouraging Indian companies by putting duty on raw materials whereas they are encouraging the importing of diagnostic kits from places like China or Korea. The government should allow us to import raw materials without duty so that we will be able to compete with these Chinese or other countries from where kits are imported," observed Dr Bhat. Naveen Kulkarni, CEO, Polyclone said, "The whole biotech industry, including the government, academia and the companies themselves, are in a growth phase. That means it is a learning curve. We are learning a lot of things. For example, DSIR broke the ice for the first time giving the R&D company recognition for a company like us. If you know traditionally it has been giving R&D recognition for companies with a huge manufacturing facility and I put forth my argument that if a company has to do product development, then one is literally forcing the company to take the technology from somebody else and make profits. If innovation has to happen, this has to happen in the beginning. And that's when it matters the most." GEAC Approvals The 79th meeting of the Genetically Engineering Approval Committee (GEAC) was held on August 8, 2007 under the chairmanship of BS Parsheera, additional aecretary, MoEF and chairman, GEAC. The decisions taken on transgenic crops in the 79th GEAC meeting include: The Member-Secretary GEAC informed the Committee that the RCGM in its meetings held on June 28, 2007 and July 24, 2007 has recommended one proposal for multi location field trials (MLRT) with transgenic brinjal, five proposals for pollen flow/ biosafety studies with Bt brinjal, transgenic cotton, Bt okra, Bt rice and Bt tomato and four proposals for Strip trials with transgenic rice, transgenic groundnut, Bt cotton and Bt brinjal expressing new gene event. RCGM has also recommended 52 proposals for MLRT and SAU trials, eight proposals for strip trials and 31 proposals for experimental seed production with Bt cotton expressing approved gene events. The Committee noted that the following recommendations/decisions taken by RCGM in the meeting held on June 1, 2007 have been endorsed by the GEAC in the meeting held on June 22, 2007. 1. MLRT for new events should not be conducted in the farmers' field. MLRT should be undertaken by the Companies/Institutions either in their own premises, research farms, long-leased land or at the SAU/ICAR institutions. 2. In accordance with the Supreme Court direction an isolation distance of 200 m should be maintained. 3. Strip trials, for new events should be undertaken by the Company in their own premises/ research farms. An isolation distance of 200 m should be maintained as per Supreme Court direction. 4. Applicant should generate complete biosafety data along with MLRT. 5. The applicant should submit a validated event specific test protocol before undertaking the trials. 6. For all new events applicants to include plant parts, such as leaves/shoot/ bolls in addition to seeds in the animal feeding studies for biosafety evalua- tion in the wake of certain reports indicating adverse effects of the leaves/ shoot/bolls on animals. 7. MLRT may be conducted in minimum 1 location and maximum at 2 locations in each State. One of the expert members opined that condition No. 4 above may not be made mandatory during the MLRT as many of the research institutions developing transgenic crops are in the process of selecting the best gene event during the MLRT. Therefore, it may not be practical to conduct the biosafety data in respect of all new gene events. The Committee while agreeing with the above suggestion also reiterated that complete biosafety data should be submitted before the proposal is considered for large scale field trials. Therefore it is up to the institution to decide for which gene event biosafety studies should be initiated and at what stage. The Committee was also of the view that in case of crops where the isolation distance prescribed under the Seed Certification Standard is higher than the 200 m prescribed by the Supreme Court, the isolation distance prescribed by the Seed Certification Standard shall be made applicable. Permission to conduct MLRT of four transgenic Bt brinjal namely Co2-Bt, MDU1-Bt, KKM1-Bt and PLR1-Bt containing cry1Ac gene (EE1 event) at five locations i.e. Horticultural College and Research Institute, Coimbatore, Horticultural College and Research Institute, Periyakilam, Agricultural College and Research Institute, Madurai, Agricultural College and Research Institute, Killikulam and Vegetable Research Station, Palur during June-September 2007 and January-April 2008 to evaluate their Agronomic performance and efficacy in controlling fruit and shoot borer and the effect on beneficial insects. by Tamil Nadu Agricultural University (TNAU), Coimbatore. Some of the recommendations in the biotech policy are already being implemented. Centers of Excellence: DBT today is supporting seven Centers of Excellence (CoEs). The DBT initiated a novel scheme for creation of CoEs, which are around people who have been outstanding and can mentor the young faculty, along with the scheme of creating CoEs in the required areas. For example, the Stem Cell Centre at CMC Vellore with a funding of Rs 19 crore. DBT earmarked about Rs 60 crore for both the CoE schemes and aims to support 30-50 CoEs in the next five years. Star colleges: To promote quality human resource, Star colleges are being established and teaching training program has been initiated. The Small Business Innovation Research Initiative (SBIRI): DBT launched the SBIRI scheme to provide early stage funding to scientists in private industries for high risk, innovative or commercializable product proposals. DBT received 70 proposals within the first month itself and DBT has supported 16 proposals. There are plans to scale up the funding under this scheme to about Rs 100 crore or so per year. To promote large partnerships, DBT has supported a major initiative between the University of Delhi South Campus (UDSC) and Mahyco. Stem cell strategy: The stem cell strategy mission program has also been initiated. DBT has evolved a strategy for stem cell research for the country. Research will be promoted for therapeutic applications using adult and embryonic stem cells as well as other more readily available sources such as bone marrow, peripheral blood and umbilical cord blood cells; focus will be on basic research and study of factors that generate stem cells and how stem cells can be stopped from proliferation; study of stem cell biology will also form an important aspect; emphasis will also be on the study of expansion of haematopoietic stem cells without differentiation and gene transduction, gene regulation and plasticity of stem cells. The Guidelines categorize stem cell studies into three main groups: permissive, restrictive and prohibitive research along with suggesting a provision for a two-tier evaluation and monitoring mechanism--one at the institutional level for permissive research and the other at the national level for restrictive research. NBRA: The National Biotech Regulatory Authority (NBRA) proposal has also been proposed for the cabinet approval. The Ministry of Agriculture, Department of Agriculture & Cooperation had submitted a Note for the cabinet for setting up of National Biotechnology Regulatory Authority (NBRA) and has resubmitted revised Note for the cabinet after the proposal was considered by the Committee of Secretaries (COS). The Government department to serve as a nodal Ministry will be decided by the Union Cabinet. If the proposal is approved by the cabinet, the Department of Agriculture and Cooperation would send the whole report to the identified Department for setting up of NBRA and taking follow up action. Besides these, the Mashelkar Committee report on recombinant pharma products has also come into effect from April 1, 2006. According to the Task Force Report, LMOs (Living Modified Organisms) are defined as only those organisms modified by r-DNA techniques through human interventions where the end product is living modified organism. The Report has rationalized the regulatory procedure for five categories of LMOs. The report also specifies the timelines for various approvals by the regulatory committees--RCGM approval for pre-clinical animal studies: 45 days; DCGI approval for Human Clinical Trials protocol: 45 days; DCGI examination of clinical trial data and response: 90 days; and Concurrent DCGI and GEAC decisions: 45 days. Another important highlight of the report is that it has recommended the Constitution of a Standing Technical Advisory Committee on Biotechnology Regulation under the chairmanship of an eminent scientist to redress and look into various regulatory aspects and make issue-based recommendations on case-by-case basis prior to any deviation from the regulatory mechanism. The National Biotechnology Strategy is awaiting the final nod of the cabinet and the industry's expectation is that the policy will offer many fiscal and non-fiscal benefits.   ]]> <![CDATA["Invitrogen is the No.1 brand for scientists in every other country in the world and we have to do that in India as well"]]> https://biospectrumindia.com/news/95/6790/invitrogen-is-the-no-1-brand-for-scientists-in-every-other-country-in-the-world-and-we-have-to-do-that-in-india-as-well.html https://biospectrumindia.com/news/95/6790/invitrogen-is-the-no-1-brand-for-scientists-in-every-other-country-in-the-world-and-we-have-to-do-that-in-india-as-well.html Tue, 04 Sep 2007 16:35:00 +0530 New Page 1 "Invitrogen is the No.1 brand for scientists in every other country in the world and we have to do that in India as well" -Gregory T Lucier, chairman and chief executive officer, Invitrogen. Invitrogen will have global sales of about $1.3 billion this year. With about 4,500 employees and headquartered in San Diego, California, Invitrogen is the largest life science consumable company in the world, primarily focused on biological experimentation tools. It has sales presence in over 75 countries and about 50 percent of its employees live outside of the US. A truly global company, Invitrogen has a strong product portfolio and i ts focus now is on expansion and shoring up of its infrastructure. Gregory T Lucier, chairman and chief executive officer of Invitrogen, who was in India this August, shares with BioSpectrum, some of the company's global and India plans. What are your some of your global plans? As part of our global ambitions, our goal is to continue to further expand our presence in the 75 countries that we are already there in and extend the footprint to even more countries, where we are not present. For example, we have little presence in South East Asia and we would like to have deeper local presence there. We have minimal presence in Africa and we think we have more opportunity there. We also recognize that in order to be a great global company, you have to have the ability to be more local. So over the last few years, we have started to move a lot of our R&D efforts to outside of the US, primarily to India and Scotland and now to Norway. What is the focus of Invitrogen in India? India for us, until recently, was a market that was relegated to distributors. But in the last 18 months, we have taken a much aggressive stance to build our own infrastructure. And that effort is now accelerated. We have opened our R&D center in Bangalore to start doing projects for the rest of Invitrogen. We have built up a very strong staff in stem cell research, bioinformatics, and proteomics. We have grown to a point where a lot more projects are coming to Invitrogen's operations in India. We are also setting up an ambitious plan to enable scientists in India to get reagents much quicker than they get today, at more competitive prices, and providing world-class technical support for reagents. Unfortunately, today, the researcher has to wait too long to get the reagents from whether it is Invitrogen or through any of our other peer companies in the industry. We are trying to change this through our relationship with Imperial Life Sciences, which is our distributor in India. We are also supporting them with infrastructure to improve the supply chain and technical support. Where do you see Invitrogen five years down the line? We will probably triple the number of R&D people in five years. We will have the ability to have scientists to order reagents and get them within 24 hours at very competitive prices. Invitrogen is the No.1 brand for scientists in every other country in the world and we have to do that in India as well. How is Invitrogen structured globally and what is your R&D size? Invitrogen has about 30,000 different products that we sell. This is a very complex set of offerings. In order to deal best with that complexity, we have established a number of business units around the world. For example, we have a cell analysis business unit, a molecular biology business unit, etc. We have about seven such business units. Each one of them has its own dedicated R&D effort, as well as manufacturing. We believe that the R&D, manufacturing, and marketing need to be co-located as much as possible to get the optimum product and technology to the customers. We have about 600 scientists and we will spend about $115 million on R&D in 2007. What is the positioning of Invitrogen today and how do you see it evolving? Four years ago, Invitrogen was primarily a genomics company. We were one of the major vendors for the human genome project in the US and most of our portfolio was centered around DNA. In 2003, we under took a strategic planning effort and we felt that science would be centered around cell and cell biology and understanding the mechanism of life in the context of the cell. So in the last four years, we acquired about 15 different companies to build up overall technology base in cell biology. Today, Invitrogen is not only a world-class genomics company but also a proteomics, cell analysis and culture company. We have deep strengths in a number of different areas where science is based today. We are engaged in virtually all aspects of cell biology. This was quite purposeful, as we wanted the ability to participate in some of the most exciting areas where science was moving-stem cell research, advanced production methods for biologics, cell therapy and molecular imaging, to name a few. An important area of focus for the company is our systems. Historically, Invitrogen "productized" science. Our kits made steps in the experimentation process faster, easier and better. We made important strides in our quest to move into more complete systems with platforms, like iBlot, released in 2006. These are a combination of bench-top devices and proprietary consumables that provide even more efficiency. In the case of iBlot, the sales in the first six months of the market launch were double our expectations. We plan to release many more experimentation systems in the coming years. We remain committed to leadership in analyzing genetic function. Scientists are just now beginning to understand that the 99 percent of DNA once considered "junk" might actually be treasure. We are already supporting this next phase of human genome research with a deep understanding of all cellular nucleic acid species, epigenetics, state-of-the-art bioinformatics, and the ability to label just about any molecule using our fluorescence and nanocrystal technologies. Our goal is to provide nothing less than a complete toolbox for this important work. Our product positioning has been a move from a genomics company to a "genomics and a cell biology" company. How different is your positioning compared to other companies? In the area of scientific reagents, the industry is structured where each participant has its own particular focus and strategy. For example, a company like Sigma-Aldrich is a fine chemicals company. Qiagen is focused more around nucleic acid purification. Our strategy is to be not only the broadest in terms of technologies but also the deepest in those technologies that we operate. Our goal is to be really a one-stop shop for molecular and cell biologists. How did the repositioning help your market capitalization? Four year's ago, our market capital was $1.4 billion. Right now, we are about a $4 billion market capital company. And our goal is to be a $10 billion market cap company by 2010. We have doubled the size of the company in the last four years. Our strategy of repositioning the company around cell biology and acquisitions has spurred the growth to a great extent in the last four years. Will there be more acquisitions? There will be more acquisitions. In fact, this year, we acquired Cascade Biologics, which is centered around cell lines and specialized media for those cell lines and some tools for cell therapy. We are a big believer that cell therapy is going to be one important therapeutics areas of the future and you will see Invitrogen making more acquisitions in the area of cell therapy tools. Asia-Pacific is one of the fastest growth areas, but what is its contribution in terms of value to Invitrogen's overall revenues? Asia-Pacific accounts for about 25 percent of our overall business. It is not the biggest, but it is certainly the fastest growing. It represents the largest incremental opportunity we have in the company. More than that, we see the future of life sciences shifting ever more into Asia-Pacific. How is the Asian market different from others and what are some of the major business challenges that one sees in the region? The first area I would like to comment on is how it is not different. In the area of scientific tools, every day is exciting, and it is one business, where a product, when launched, is done globally. It is because science is practiced the same everywhere. It is standard and the tools and techniques that people use are common around the world. In terms of Asia-Pacific, where the challenges lie are that there a lot of countries and there is a lot of space and distance between them and each country has a very particular government regulations regulating the inflow of scientific tools. And that makes it a very difficult supply chain challenge. So our biggest focus is on supply-chain excellence-warehouse, logistics of moving the products, ordering of technology and technical support, etc. Ch. Srinivas Rao   ]]> <![CDATA['We've begun Panflu phase II trials']]> https://biospectrumindia.com/news/95/6172/weve-begun-panflu-phase-ii-trials.html https://biospectrumindia.com/news/95/6172/weve-begun-panflu-phase-ii-trials.html Tue, 04 Sep 2007 16:21:00 +0530 New Page 1 'We've begun Panflu phase II trials' -Weidong Yin, President & CEO, Sinovac China's leading emerging biotech company, Sinovac Biotech (also known in China as Beijing Kexing Bioproducts) specializes in the research, development, commercialization, and sales of human vaccines for infectious illnesses such as Hepatitis A and Hepatitis B, influenza and SARS. Working closely with Chinese public health officials, Sinovac focuses on manufacturing and marketing human-use vaccines and related products, and currently markets its vaccine for Hepatitis A. Sinovac is the first and currently, the only company in the world to have been granted permission to begin clinical trials for a vaccine to prevent SARS. In an e-mail interview with BioSpectrum, Mr Weidong Yin, President and CEO, Sinovac, elaborates on the success the company has had with its various products. How well are Sinovac products (Healive, Bilive and Anflu) doing? Which one is the best seller? There are three products on the market, Healive: the first Inactivated Hepatitis A vaccine in China, Bilive: Hepatitis A &B combined vaccine and Anflu: the Split Influenza vaccine. Healive was launched in 2002. In the past, most inactivated Hepatitis A vaccines in China were imported from other countries. Through the National Ninth Five-year Scientific and Technological Project on medicines, we successfully developed the first proprietary inactivated Hepatitis A vaccine in China and commercialized the vaccine. The clinical research data shows the seroconversive rate of the subjects inoculated with the vaccines for full vaccination schedule is 100 percent and the safety, immunogenicity, the clinical result and the quality of the vaccine is comparable to the imported inactivated Hepatitis A vaccines. Currently, Healive is being sold in 27 provinces in China and is the most widely used inactivated Hepatitis A vaccine in the country. In 2006, 2.6 million doses were sold in China, which generated the sales revenue of RMB 100 million. Bilive was launched into market in 2005, which is used to enhance the immunogenicity. As the supplement of Hepatitis A vaccine and Hepatitis B vaccine, the demand is not very large. Anflu was launched in the autumn of 2006 and the key purpose is to introduce the new product to our customers. Who are your main customers for each of these products? In China, the disease control system includes provincial CDC, municipal CDC, county CDC and inoculation clinic. Sinovac's vaccines are distributed through different CDC systems in China. Based on the principle of disease control, companies provide the high-quality vaccines to the disease control system. Sinovac sells all its vaccine products only to provincial, municipal, and county CDCs. The provincial CDCs and municipal CDCs are responsible for purchasing the vaccines and then distributing it to subordinate CDC and inoculation clinic, which regulate the execution of vaccination program. Currently, what kind of method is Sinovac using for vaccine production? Cell culture or eggs? Sinovac has used and established several technology platforms during the production process, which involves all aspects in vaccine production. We use different platforms according to the types of vaccines. For example, we use egg-culture to produce influenza vaccines and cell-based technology to produce Hep A antigens. What are your views on DNA vaccine? Will it be workable? When? DNA vaccine is a new development in vaccine technology. The technology can be used as foundation for the development of future vaccines and speed up the R&D process of vaccines. Compared with traditional vaccines, DNA molecule is more stable, making it easy for transportation and storage, but some issues need further research. Those are whether DNA vaccine, as an exogenous DNA, could intergrade or interrupt the normal function of DNA in host, whether these exogenous DNA could induce immunifaction. With the development of technology and research, DNA vaccine will bring huge benefit for human beings. What other products are in the pipeline? Our product pipeline includes pandemic influenza vaccine Panflu, Japanese Encephalitis vaccine and SARS vaccine. Panflu is being co-developed by Sinovac and China CDC, and its phase II trials commenced in May 2007. For the Japanese Encephalitis Vaccine, we are getting ready with the application for phase I clinical trial. For SARS vaccine, phase I clinical trial has been completed. However, the entire three phases of clinical trials cannot be completed without outbreaks. Currently, as there are no more cases, the project is suspended. We intend to resume the process required to obtain regulatory approvals if the virus re-emerges. Can you please elaborate on the avian flu vaccine that Sinovac is working on? At what stage of development it is now? The China State Food and Drug Administration (SFDA) recently granted Sinovac approval to commence the phase II clinical trial of Panflu, a human use vaccine against the H5N1 strain of pandemic influenza virus. Two types of the H5N1 vaccine were approved by the SFDA to commence clinical trials. The first type is the H5N1 whole viron inactivated vaccine for which the phase I clinical trial was completed in 2006. The phase Ib and II clinical trials for the H5N1 whole viron inactivated vaccine will be conducted to further test the tolerance, safety, and immunogenicity and to determine the dosage and inoculation schedule. During the phase Ib and II trials, the age-groups of the participants will be enlarged by adding youths and the elderly. The second type of vaccine is the H5N1 split viron vaccine, for which the phase I and II clinical trials will be conducted continuously. The trials will focus on the vaccine's tolerance, safety, and immunogenicity. It is anticipated that the phase II clinical trials will commence simultaneously for the two types of vaccines in order to determine the vaccination dosage and inoculation schedule for drafting the registration standards and specifications for the vaccine. Sinovac commenced development of Panflu in February 2004 as part of the global united battle to fight against pandemic influenza. In June 2006, the results of phase I clinical trial were unblinded and showed good immunogenicity and safety. On September 7, 2006, the results were published in The Lancet, a global renowned medical periodical, that provided worldwide recognition for the phase I clinical trial results of the pandemic influenza vaccine (H5N1) developed by Chinese scientists. Sinovac has received invitation from WHO to participate into the campaign to solve the issue with access to pandemic flu vaccine by developing countries. We are willing and capable to help our country and many other countries for this public health issue. Has Sinovac turned the corner financially? In 2006, Sinovac incurred a loss, but net loss decreased by 86.4 percent to $696,000 in 2006 from $5,111,000 in 2005. Nandita Singh ]]> <![CDATA['More new drugs will be discovered, developed in Asia']]> https://biospectrumindia.com/news/95/1841/more-new-drugs-will-be-discovered-developed-in-asia.html https://biospectrumindia.com/news/95/1841/more-new-drugs-will-be-discovered-developed-in-asia.html Tue, 04 Sep 2007 16:11:00 +0530 New Page 1 'More new drugs will be discovered, developed in Asia' -Dr Thomas E D'Ambra, CEO & President, AMRI Founded in 1991, Albany Molecular Research (AMRI) provides scientific services, products and technologies focused on improving the quality of life. AMRI works on projects for many of the world's leading pharmaceutical and biotech companies. AMRI just completed acquisition of two pharmaceutical manufacturing sites, along with additional land for expansion, in Aurangabad and Navi Mumbai, India for approximately $11 million in cash. Also, the company recently entered into a natural products-based drug discovery collaboration with Achaogen. With locations in the US, Europe, and Asia AMRI provides customers with a wide range of services, technologies and cost models. In an interview with BioSpectrum, Dr Thomas E D'Ambra, Chairman, CEO and President of AMRI elaborates on the opportunities in the Asia Pacific region. Excerpts. What were the reasons that motivated AMRI to invest in R&D and expansion of its businesses in the Asia Pacific region? Post September 11, 2001, the dynamics of the industry changed. There was an economic recession in the US and budgetary cuts by big pharma occurred. Small biotech or emerging pharma companies had difficulty getting funding because capital markets were tight. At the same time, many of the large pharma companies had gotten comfortable with the concept of outsourcing. They desired to continue and even expand their outsourcing, even if they couldn't afford the level of outsourcing spending of the past. It became increasingly clear that these companies were willing to look at offshore outsourcing as a means to increase productivity-and many new outsourcing companies, particularly in Asia, were eager for this business. In our minds, the world was changing. So, four years ago we started looking at globalization of our business. We considered Eastern Europe, Russia, India, China, Singapore and other countries. At the conclusion of our process, we decided to focus initially on expanding into India and Singapore. Singapore was attractive partly because of government support for establishing and growing the biotechnology research industry here. Singapore also has Western standards when it comes to treatment of intellectual property and conducting cutting edge research. Subsequent to our initiatives begun in Singapore and India, we also purchased a facility in Budapest, Hungary, which gave us a presence in Europe. The globalization of our business was not only to offer offshore outsourcing opportunities to our customers in the West but, more importantly, to globalize our customer base. Historically, we have worked predominantly for North American and European customers. Drug discovery and development is increasingly a global business opportunity. Being close to an expanding customer base in part prompted us to look at establishing a presence in the Asia Pacific region. How do you see the opportunity now in the Asia Pacific region as compared to two years ago? The biotechnology and healthcare research industries are evolving in the region across the board, yet each country is different. For example, Japan's economy has been performing well over the last couple of years. The drug industry in Japan is very different from the other countries. Many Japanese conglomerates have pharma brands and new drug R&D in Japan. Since the economy is relatively healthy, it would appear that more investment is going into budgets for pharmaceutical research and development in Japan. Mergers and acquisitions are beginning to occur on a significant scale in Japan, creating larger, healthcare focused companies. More recently, small biotech companies have been gaining traction in Japan as well. We believe that the Japanese market represents significant opportunity for AMRI to provide services. In a different way, Australia is also becoming more significant in the healthcare research industry. Singapore is on the way to reaching critical mass. Potential customers in other countries, including Korea, Taiwan and even China represent business opportunities for us. With globalization, cutting edge drug discovery and development activities are taking place in this region. Historically, outside of Japan, the Asia Pacific region was dependent on other parts of the world for the development of new medicines. That is changing. One can expect, in the long term, more new drugs will be discovered and developed in the Asia Pacific region. Recently, AMRI completed two acquisitions in India for manufacturing purposes. What were the reasons for choosing India over other countries like China and Japan? As mentioned previously, we conducted a lengthy process in which we looked at several countries and regions for potential expansion. We have a sales and marketing presence in Japan. We evaluated Korea and China. Both have their advantages. However, for a variety of reasons, we felt initially we should focus on expanding into India instead of China, partly because of India's longer history of manufacturing APIs to GMP standards. As a result, there is an infrastructure of training in chemical synthesis, analysis and the regulatory infrastructure to support our expansion. Other reasons for choosing India initially are a growing economy, deep talent pool, a presumed more stable currency and long term horizon, a more western friendly government and the ability to communicate in a common language at multiple levels in our organizations there. What will be your future plan of action for the Asia Pacific region, where a lot of activities are taking place in the life sciences industry? We have recently acquired two manufacturing facilities in India. This autumn we will be opening a newly built lab facility in Hyderabad, India with custom synthesis and kilo scale capabilities. We are also expecting to significantly increase our scientific head count at our Singapore center and add in vitro biology. Over the last several years AMRI has made significant investment in the region. We plan to focus on these investments, grow them and help them to deliver significant value to the many customers we are working with. Over time, one has to continue to look at other markets, particularly China. We believe that China cannot be ignored, yet at the same time it is not clear as to how its future will come to be. Many US big pharmas are establishing significant relationships with Chinese partners-and several have begun to establish their own research facilities there. We have experience with how fickle these companies can be. At some point one can expect a global recession. Times of great difficulty are also times of opportunity. We are continuing to monitor the marketplace and gaining experience operating across different cultures. If the right opportunity presents itself, we will have to seriously evaluate expanding into China. This may or may not happen. For now, however, we have our hands full focused on the several initiatives we have already put into place. Narayan Kulkarni   ]]> <![CDATA["Sartorius Stedim Biotech is one of the leading companies in bioprocessing technology"]]> https://biospectrumindia.com/news/95/2913/sartorius-stedim-biotech-is-one-of-the-leading-companies-in-bioprocessing-technology.html https://biospectrumindia.com/news/95/2913/sartorius-stedim-biotech-is-one-of-the-leading-companies-in-bioprocessing-technology.html Tue, 04 Sep 2007 16:01:00 +0530 New Page 1 "Sartorius Stedim Biotech is one of the leading companies in bioprocessing technology" -Dr Joachim Kreuzburg, CEO, Sartorius Stedim Biotech Laboratory and process technology provider Sartorius acquired a majority stake in France-based biotechnology supplier Stedim Biosystems and combined its biotechnology division with Stedim carving out a new entity Sartorius Stedim Biotech. With the integration of these two now declared complete, the new entity Sartorius Stedim is set to close year 2007 with about $550 million in revenue and is focused on the biotech niche According to CEO, Dr Joachim Kreuzburg, this strategic move will allow the company to offer fully integrated solutions for next generation biopharmaceutical manufacturing. He stated that given the strong double-digit growth rates in the biopharmaceutical markets and the market shift to disposable solutions this is just the right move in the right direction. Excerpts from an interview with Dr Kreuzburg: What decided the case in favor of Stedim acquisition? After we had sold single-use bags for several years through a model of cooperation, both the technological and economic reasons spoke in favor of including this technology in our own portfolio of expertise. Aseptic bag technology is becoming a platform technology for further single-use products, such as disposable bioreactors or single-use aseptic transfer systems. Even completely new applications are conceivable, for instance, in the laboratory area. We assume that the development of this market is just beginning and are therefore aspiring to become the global market leader in the field of single-use products for biotechnological applications. The fact that Stedim offered us the special chance to acquire the market leader in single-use bag technology was, naturally, too good an opportunity to pass up. Stedim not only contributes its technological expertise and market share to our group, but also has outstanding production facilities in France, Tunisia and the US, which is important for our customers, from reliable delivery service aspects. After the integration how is Sartorius Stedim Biotech positioned? In this merger, Sartorius brought value with its technologies in the areas of fermentation, filtration, purification and laboratory applications while the sector of fluid management came from Stedim. Sartorius Stedim Biotech is one of the leading companies in bioprocessing technology, globally. We are also a leading supplier in fermentation, bioprocess filtration and various purification technologies, such as membrane chromatography, which are all core technologies from Sartorius. None of our competitors have such a broad range of products. We provide total solutions and will continue to follow our approach of supplying our customers' needs for technologies and products all along their bioprocessing chain. What makes India a favorite? "Compared to the US and Europe markets, Asian scenario is very interesting. There is a huge growth potential, however, countries in Asia are not only characterized at different growth rates but also have different levels of technology penetration and different development levels. The business in India is growing at a fast rate making it very appealing. Biotech market in India is interesting and not only because of its sheer volume, India is also ideally suited for our product and technology portfolio. For our growth, in the next five years there is a strategic role-play attributed to India. We are consolidating our operations in India in one campus. For us, a local facility to run process trials, validations and to develop new processes together with our clients is crucial for our local business development. It will enable us to stay in line with the customer support that is expected from us in view of the growing business. From this facility we will also support our global customers. India has a well-established manufacturing base and skilled human resource pool, which puts it ahead of other countries in Asia in terms of growth potential. Sartorius Stedim's value proposition is the whole package that we bring to the life sciences industry in India. I believe our base in the biotech industry in India is well-covered. Now, we will build on the strengths that we have created in this market." What are the synergies between Stedim and Sartorius product portfolios? The synergy is in single-use bags and sterilizing-grade filters, because the two are used in tandem as a rule. Currently, approximately 10 percent of our sterilizing-grade filters are channelled into applications with single-use bags, and we estimate that this proportion will increase in the next few years to around 30 percent. Here, we assume that the market for applications with single-use bags will grow faster than the remaining market-and thus become the growth engine for our filter business. And, naturally, by focussing on this segment, we will be securing our sales market for sterilizing-grade filters. Nandita Singh Sartorius strengthens biotech business -Dr Joerg Lindenblatt, Vice President, Sales-Asia, Sartorius Stedim Biotech Sartorius has got it right on a number of counts. The strategic focus on biotech, a product portfolio spanning from lab-to-pilot-to-full scale production, the focus on growing markets such as India, and now the acquisition of Stedim-the global market leader in disposable technology. In tune with the trend in US & Europe, the dispoables uptake in the industry is growing at a fast rate in Asia as well. In India, though the absolute numbers are not particularly inspiring by themselves, in the next five years the situation will clearly change for better, believes Dr Joerg Lindenblatt. Based out of Goettingen in Germany, Lindenblatt spearheads the company's Asia market initiatives. And, these days, India is his favorite country. It pays to take a position in the market, early. "Early stage business pitch is much easier. Being a consultant to customers and helping them achieve their objective is what we focus on," says Lindenblatt. According to him, given the way Indian biotech segment is growing, the untapped potential is high. It is this untapped potential that is making him spend every fourth week of his life as the "India week". Sartorius is focused on leveraging its strong established base in India. The company has made a beginning in the direction by consolidating its operations in the country. By mid-2008 Sartorius will start operating from its new campus in Bangalore. "In our five-year planning India plays a major role, not just sales-wise but resource-wise as well," informs Lindenblatt. According to him, the integrated campus is a necessity to stay in line with the support that Sartorius Stedim customers need. The facility will have validation labs and process development facilities, which will serve local and global customers. The company has three other such labs in the US, Europe and Japan respectively. The facility in India will also work as backup and support for these labs.\ Nandita Singh ]]> <![CDATA[CRO market becoming increasingly globalized]]> https://biospectrumindia.com/news/95/2093/cro-market-becoming-increasingly-globalized.html https://biospectrumindia.com/news/95/2093/cro-market-becoming-increasingly-globalized.html Tue, 04 Sep 2007 15:49:00 +0530 New Page 1 CRO market becoming increasingly globalized India is becoming the most popular destination for outsourcing CRO activity. According to Datamonitor's recently published report "R&D Strategies 2007", the drug development industry is facing a number of serious challenges, making it vital that companies implement an R&D strategy that can power strong future innovation. R&D productivity depends on accelerating and boosting the output of drug discovery and development, and there are a range of strategies to do this, including optimizing the R&D model and improving the R&D process. Datamonitor has identified twelve strategies that can boost R&D productivity. Datamonitor's R&D Strategies 2007 report points out that the CRO market is becoming increasingly globalized. An Economist Intelligence Unit 2004 White Paper indicated that 70 percent of companies surveyed had overseas R&D functions, with more than half of those questioned indicating that their investment in overseas operations would increase over the next three years. Big Pharma has expanded its research presence overseas substantially in the last decade, and many western multinationals have an R&D presence in emerging markets. Additionally, drug developers have become increasingly dependent on CROs, which themselves have become increasingly globalized. This is being driven by both the rise in the number of CROs in emerging markets and the increasing internationalization of western CROs. Most global CROs are present in India or have formed alliances there: seven out of the top 10 CROs have local offices in India ("Clinical Grant Budgeting & Negotiation in India and China", CHI presentation, Februaryâ€“March 2007), with leading companies such as Quintiles, Chiltern, ICON Clinical Research building up a significant India presence. Meanwhile, local CROs are picking up pace, and there is likely to be a period of consolidation in this sector. The report points out that India and China are the most popular emerging countries for outsourcing CRO activity. Of the four BRIC countries, India and China have proved the most popular for emerging market CRO activity. There are a number of similarities between the two countries. Both are enjoying strong GDP growth, yet their infrastructure is struggling to support such growth. Both have strengths in basic research and a willingness to approve innovative drugs. For example, China approved the first gene therapy-SiBiono's Gendicine-in November 2003. Additionally, both have the potential to develop into leading drug markets, which is helping to increase CRO activity there. Indian CROs: Advantages and disadvantages According to Datamonitor, India's huge patient and specialist pool, together with its enthusiasm, are the strongest benefits of working here. The principal benefits associated with working in India include: High level of patient consent: 70 percent of patients return with informed consent. This represents a large number of patients, although caution should be taken in accepting this on face value, due to concerns relating to the fact that many patients providing informed consent have low literacy levels ("Translational Medicine-Why India", CHI presentation, Februaryâ€“March 2007); Chemistry expertise: Innovative reverse engineering by generics companies and experience as a key chemistry outsourcing target have created a strong chemistry knowledge base. Talent pool of high quality and enthusiastic medical staff, researchers and investigators with strong work ethics: India has the second-largest pool of qualified medical doctors globally, after the US ("Clinical Research in India-Opportunities & Challenges", CHI presentation, Februaryâ€“March 2007). These researchers are English-speaking and many leading specialists have been trained in Western countries. Additionally, there is a large pool of Indian doctors practicing in the Western markets, helping to boost the profile and reputation of scientists from these countries. There are around 200 formally-trained investigators of Good Clinical Practice (GCP) in India ("Clinical Research in India-Opportunities & Challenges", CHI presentation, Februaryâ€“March 2007). Finally, there are strong patient-physician relationships, leading to a high level of patient retention. Government initiatives: In addition, a range of government initiatives have improved the environment and reduced the risks associated with carrying out research in India. The government's removal of the limit on foreign direct investment in the pharmaceutical, industry, allowing 100 percent foreign ownership of enterprises (April 2002) is an example. IP legislation to enforce product patents, including pharmaceuticals, was strengthened in January 2005 with the "Composition of Matter" IP protection, which allows the recognition of product patents ("Translational Medicine-Why India", CHI presentation, Februaryâ€“March 2007). This builds on the introduction of a bill to bring India's IP protection in line with the WTO (December 2002); amendments to Schedule Y in 2004 allowed proof-of-concept studies to be carried out in India. Previously, trials had to lag work done in other countries by a phase of development. Now, Phase II and III trials can be run at the same as other global trials. Although Phase I must still be conducted elsewhere, drugs partnered with Indian firms may qualify as domestic, allowing these trials to be carried out in India ("Translational Medicine-Why India", CHI presentation, Februaryâ€“March 2007). India has now mandated International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use GCP guidelines for all clinical research in India, and companies, hospitals and clinics are beginning to comply with GCP guidelines; the government has removed customs duty on materials imported for clinical trials (customs duty had been as high as 55 percent in the past) and will provide 10-year tax breaks to companies making R&D investments in the country. Regulatory and IP protection remain an issue, as does the level of biological expertise. Chinese CROs' advantages and disadvantages The workforce is the principal benefit associated with outsourcing to China The key benefits of working in China include: Increasingly strong IP protection-the country joined WTO and TRIPS in 2001; Availability of non-human primates for preclinical trials; Increasingly harmonized regulatory process: the State Food and Drug Administration (SFDA) is modernizing to harmonize with the EMEA (European Medicines Agency) and FDA; High numbers of professionals-China has 18,000 hospitals, over 1.5 million physicians, and >1.6 million well trained registered nurses ("Clinical Grant Budgeting & Negotiation in India and China", CHI presentation, Februaryâ€“March 2007). Challenges The challenges associated with working in India include: Given the increasing importance of biomarkers, there are questions over whether scientific advancement in this and related "omics" fields is at a comparatively early stage in India compared with the major Western markets. Specifically, it is questionable whether CROs will be able to provide validated assays and handle samples; Compliance and service levels vary widely; Cultural issues-bad news is rarely effectively communicated and there is often a lack of transparency over it, and there have been problems over keeping to timelines; The regulatory approval process needs to be more streamlined and predictable; Contract regulations are convoluted-it takes 56 steps and 1,420 days to enforce a contract in India, compared with 22 steps and 351 days in the OECD (World Bank Group 2006 data reported in "Opportunities and Pitfalls of Establishing a R&D Service Organization in India,", CHI presentation, Februaryâ€“March 2007); Government initiatives are required to strengthen ethics committee approval process; Historically weak IP protection; Corruption remains a problem; Salaries of highly skilled workers are rising rapidly; Quality manufacturing and R&D capacity are beginning to reach their limits. Key findings of Datamonitor R&Dstrategies report In the course of its research and analysis for the Datamonitor report: R&D Strategies: Incremental improvements and paradigm shifts in strategy are both necessary to boost productivity, Datamonitor identified the following key conclusions: Based on continuing reductions in the number of innovative drug approvals and further rises in the average cost of drug development, many industry commentators have suggested that the drug development industry is facing an R&D productivity crisis. However, some commentators have suggested that it is too soon to state that the industry is in crisis, as a result of the ultra-slow nature of the industry. Together with further evidence showing that the number of drugs entering clinical trials is rising, this makes it difficult to determine how much in crisis the industry is. However, irrespective of whether this is taking place or not, there are a number of factors that are changing the R&D environment and making drug developers increase their focus on improving productivity and be more responsive so they are better placed to capitalize on opportunities. As a result, optimizing R&D strategies has become vital in ensuring survival and continued profitability; Datamonitor analysis of MedTRACK databases has revealed a number of trends. Firstly, early-stage companies are the most active deal makers both as source and partner company. This is likely to result from the fact that they are playing an increasin gly prominent role in supplying novel drugs and technologies to the market, yet they lack the full integration of Big Pharma players, therefore conduct multiple deals to source specific functionalities and to gain the backing of a bigger player. As a result, co-development and licensing deals remain the most popular deal types. Additionally, oncology remains the dominant deal target, and the most popular therapeutic focus for drugs currently in clinical development, however its dominance of the pipeline does vary slightly by phase; Datamonitor has identified a range of recommendations to improve R&D strategy. These can be themed around two areas. Firstly, drug developers can implement improvements to the R&D model. Such measures include building stronger interaction with internal and external functionalities, including introducing more effective interaction with regulators. Additionally, drug developers should look to optimize R&D processes, both from a preclinical perspective (e.g. by optimizing the way that clinical trials are designed and carried out) and from a clinical perspective (e.g. improving interaction with KOLs, regulators, patients and P&R teams). Cancer is the most popular therapeutic deal focus across deals of all clinical phases, however it is considerably more popular in early-phase than in late-phase. This suggests that later-stage promising cancer indications have all been snapped up by Phase III and that drug licensors are having to look at earlier-stage to identify promising deals. This article has been written by Datamonitor analysts.     ]]> <![CDATA[Biotech industry too hit by Dollar depreciation]]> https://biospectrumindia.com/news/95/2075/biotech-industry-too-hit-by-dollar-depreciation.html https://biospectrumindia.com/news/95/2075/biotech-industry-too-hit-by-dollar-depreciation.html Tue, 04 Sep 2007 15:46:00 +0530 New Page 1 Biotech industry too hit by Dollar depreciation With exports contributing for over 55 percent of share of the total sale revenues of the Indian biotech industry, it cannot remain immune to the rising rupee value. Announcing the unaudited financial results for the quarter ended June 30, 2007, Rajesh Jain, joint managing director, Panacea Biotec observed, "The current financial year is full of challenges for all those companies which are deriving major revenues in foreign currencies particularly in US Dollar, as the domestic currency has appreciated significantly against the US Dollar. Panacea Biotec has registered growth in its forex earnings as well as domestic business both pharma and vaccines, however the impact of growth was nullified by around 10 percent appreciation in the Rupee against the US Dollar during the quarter under review as compared to corresponding quarter of previous year." Panacea Biotech registered a net turnover of Rs 233.4 crore during the quarter ending June 30, 2007 compared to Rs 233.4 crore for the corresponding quarter of previous financial year. Its revenues from pharma (formulations) segment grew by 27 percent at Rs 49.8 crore, with the domestic turnover registering 26 percent growth and export turnover growing by 36 percent. The vaccine business registered turnover of Rs 183.7 crore during Q1 2008 compared to Rs 194 crore during the Q1 2006. Biotech major Biocon's sales in Q1, 2008 grew by 28 percent to Rs 227.4 crore and operating profits by 40 percent. Commenting on the results, Kiran Mazumdar-Shaw, CMD, Biocon Ltd, said, "I am pleased that we have delivered robust and growing profits at a time when we are challenged with increased RD investments, strengthening currency and rising operating costs. This has been possible due to expanded markets for our biotherapeutics as well as significant licensing income from our R&D programs." Shaw acknowledges that there has been some impact due to the dollar depreciation. Responding to the analysts conference call on the sort of impact Biocon saw both on its revenues and on the treasury income, Shaw said, "This has impacted some of our earnings, because you know that we have a high dollar denominated revenue income, and some of this we have hedged because they are on a contractual basis, but there is a lot of this business that cannot be hedged because of the fact that some of the businesses are really on spot purchases. So we have tried to do as much as we can to safeguard the impact of this." The extent of impact is not yet clear, but the impact is being felt by both small and big companies say industry executives. Dr Shama Bhat, managing director, Bhat Biotech, said, "The rupee has become so strong it is very difficult to export today. We are a very small company but we are exporting more than 50 percent of our products into several countries, majority of them are going to South Africa where for the last 15 years we got some government orders which we are able to supply. We are exporting Parikshak HIV at 52 cents. Two years ago we got this tender. At that time, the rupee value was Rs 48. That translates into about Rs 25 per test. Today the same 52 cents at Rs 40 will be around Rs 22.80. We lost about Rs 4.20 just because of that." Would it mean there would be benefit because most of the raw materials are imported? "We can import raw materials at the depreciated rate. But unfortunately what happens is our input is less than 5-10 percent of the raw materials wherein we may be saving about Re 1 per test. That means net loss of about Rs 3.20, i.e, about 15 percent loss in our margins. Because of global competition, we cannot mark up the prices so high and the margins are very slim. Companies like us are really struggling and we are losing money. Because of the tenders and government supplies, we will not be able to raise the price. The government has promising to do something. However, it is almost three-four months but nothing has been done. This is one area where they have to act fast so that companies will be able to compete with others and survive." To give relief to exporters hit hard by rupee appreciation against dollar, the Centre announced a Rs 1,400-crore fund, including increased rates of duty drawback with effect from April 1. Besides, the Centre has asked the banks to extend cheaper credit to exporters at an interest rate not exceeding BPLR minus 4.5 per cent on pre-shipment credit up to 180 days and post-shipment credit up to 90 days on the outstanding amount for period between April 1 and December 31 this year. Further, the ministry of finance has accorded relaxation from monthly and quarterly ceilings of expenditure for deemed export benefits to enable the commerce ministry to meet the pending reimbursement claims, which are estimated to be in the order of Rs 600 crore. Though the industry has welcomed the announcements, many feel this is short of expectations. Will the biotech industry ask for some share of the Rs 1,400 crore package? Dr KK Narayanan, president ABLE said that the association is planning to ask for it. "The center has announced that it will do something about the interest rate even though it would directly not be able to tinker with the exchange rate. I do not know how far this will have impact. This is affecting other sectors too. Even software companies and others are finding it difficult to service their customers. It is a wider issue. There will be many more people fighting this issue." Indian biotech companies are trying to import a lot of instruments and this may work in the industry's favor say some executives. Almost about $1.5-2 billion worth of instruments will be imported in the next two years, which may be good news for the biosuppliers. There is another section of the industry which feels dollar depreciation will work in its favor if it is scouting for mergers and acquisitions, considering that many of the Indian companies are looking at acquisitions. In the past few months one has seen an increase in the M&A activity. Irrespective of what the impact is, companies in India are bracing up to tackle the changing environment. Ch.Srinivas Rao with Namratha Jagtap   ]]> <![CDATA[Academia and industry should work more closely]]> https://biospectrumindia.com/news/95/2279/academia-and-industry-should-work-more-closely.html https://biospectrumindia.com/news/95/2279/academia-and-industry-should-work-more-closely.html Tue, 04 Sep 2007 15:44:00 +0530 New Page 1 Academia and industry should work more closely The BioSpectrum CEOs Summit 2007 in Bangalore discussed ways to bridge the existing gap between the industry and academia. The third BioSpectrum CEOs Summit kicked off with its Bangalore leg on August 17, 2007 at The Grand Ashok, Bangalore. Addressing a gathering of industry leaders and representatives from the academia, Narayanan Suresh, Editor, BioSpectrum, who moderated a discussion on bridging the industry-academia gap, said there are about 300 institutions in the country offering biotechnology courses and these institutions have been churning out as many as 30,000 students every year for the last few years, but as per the BioSpectrum-ABLE survey, the industry today employs about 20,000-25,000 personnel in the technical and scientific categories. "This set us thinking as to what could be the reason for this kind of mismatch and this is something which we wanted to explore. Hence we thought apart from the industry people, the other stakeholders (academia) of the industry should be equally present here at this forum and we should give them an opportunity to interact with the industry captains who keep complaining about talent crunch in the industry. This platform should help come up with solutions which will ensure smooth flow of talent from the academia to the industry," Narayanan Suresh stated. Pointing out to a recent report in New York Times that India is introducing very contemporary issues in school and college curriculum including latest political trends, Narayanan Suresh said, "We would like to explore if the same has been happening in biotech institutions. Are the students being taught what's current in the industry?" The discussion panel comprised Dr Vijay Chandru, chairman, Strand Life Sciences, Dr Jagadish Mittur, director, Monsanto Research Centre, Prof. HN Nagendra of the Visvesvaraya Institute of Technology (VIT), Dr Geeta Bali of the Bangalore University, and Dr PS Rao of the Dayanand Sagar Institutions. Describing himself as an "intellectual poacher", Dr Vijay Chandru said he was trained in electrical engineering and computer science and "somehow found my way into the life sciences." When asked about the challenges he faced while recruiting people, he said, "The primary challenge in terms of recruitment has been essentially the challenge of finding highly skilled computer scientists. It is very difficult as essentially we are competing with the Googles and Yahoos (IT majors) of the world. We need to find out the underlying interests potential candidates have in the life sciences and then rope them in. Purely trying to attract them with big salaries would be very hard." Mooting the concept of tele-education in the country, he said the government should think of implementing PG diplomas in specialized courses, take steps to enhance the quality of education and also introduce refresher courses. Dr Jagadish Mittur agreed it was not easy to find competent computational biologists. "Here we are competing with the Intels, IBMs, Wipros and Infosys and also pharmaceutical companies. It is easier to attract them into a pharmaceutical company as opposed to an agricultural company because agriculture seems to be somewhat more controversial than a pharmaceutical company...people never ask questions when it comes to taking a drug but people will have questions when they have a choice of food. So it is that much more difficult to attract people of high caliber into an agri company. Nevertheless Monsanto has been very successful in research. Here in Bangalore, we are about 60 people in the area of biotechnology and we also house an IT group of about 40 people and I know the IT leads in an agri company like ours face a lot of challenges to keep them going. My passion is to really interact with the academicians and students to build a sense of passion towards agriculture because India is an agricultural country. If we do not solve problems we have in agriculture, I don't think India will progress to the extent that the government and the leaders are trying to dream of," Mittur said. "Although Monsanto is a life sciences company, it is only one-third of the strength that is actually life sciences oriented. We need other people to support the industry and that includes finance people, lawyers, patent scientists, and HR experts. Getting a degree in life sciences these days is not really enough or is not the end of the road. There are many lateral ways of growing a career in life sciences, but what is important is to develop a passion towards the field that you are in like for instance agbiotech or a passion for developing drugs or vaccines for the community or for animals or finding new sources of energy. If we don't have that ingrown, heartfelt passion, it is very difficult to survive," he opined. Dr Geeta Bali of the Department of Microbiology, Bangalore University, said, "There is total agreement that the students who come out of academic institutions should match the needs of the industry. The disagreement only comes in judging the quality of the students." She said about 10-15 percent of the talented students, whom the industry would really love to have, are the ones who do not wish to join the industry. They go aboard for higher studies or join premier institutes to do their PhDs and in the process we lose them. Is there any way to attract them? Educational programs should be integrated in such a way so as to facilitate awarding PhDs to students while they are working and this will definitely attract the best of the students to the industry, she felt. Stating that the Bangalore University had taken steps to introduce subjects like nanobiotechnology, medical biotechnology and IPR issues and bioethics in the syllabus over the last few years, Dr Geeta Bali said the syllabus had to be modified every year as there were more and more students coming from diverse backgrounds. Dr PS Rao felt there was an urgent need to tailor the current biotech syllabus to suit the needs of the industry. "These days biotech graduates are not qualified enough to effectively take up job responsibilities in the industry as they lack practical skills. Therefore we need to have experimental protocols and take steps to restructure and upgrade the syllabus," he said. Lamenting over the dearth of quality faculty in biotech institutions, he said other factors such as lack of infrastructure and improper basic education had only added to the worsening education scenario. "I would highly recommend refresher courses for the faculty. The quality of education is totally unresponsive to the biotech industry," he pointed out. He felt that the Bangalore University, which had taken out the project work from the syllabus, had to reintroduce it in the curriculum. Stressing on the dire need for establishing biotech finishing schools in the country, Dr Rao said students require at least a six-month hands-on training program and six months internship in the industry before they can think of shaping up their career in biotechnology. Sharing similar views, Prof. Nagendra of VIT said the first and foremost important thing was to ensure that educational institutions produced quality biotech engineers who would be competent in the industry. He felt BE (biotech) graduates have an edge over the conventional BSc/MSc students as they come from a mathematical background and possess better analytical skills. "These days the industry people need to interview several candidates before they can find the right one. They need to support and identify talent pool through capacity building exercises. Biotech institutions should cease to become mere degree churning organizations and public funding initiatives is the need of the hour to nurture talent," he emphasized. There were several other suggestions from the industry as well academia. Naveen Kulkarni, CEO of Polyclone Bioservices pointed out that the major concern is not how current the syllabus is, but hands-on training. It is a very simple thing that academic institutions have to do...we study something but we don't do that in the practice and this is much more prevalent in India. "About 10 years back, I went to Australia for my PG, I had to take one UG subject and genetics was the subject. In theory I scored well, but when it came to practicals, I just could not even gas the drosophila and the experiment continued for a week until we saw the difference in the eye color and so on. I lost it in my first lab. That was a major issue," explained Kulkarni. Genetics being a basic subject, we do not have relevant practicals in our education. Rather than talking about nanotechnology and whatever else that's coming in current trends, the industry should focus on simple things, i.e., what you read is what you do. Together the learning comes in. I think we are missing that point. Prof. C Kameswara Rao, executive secretary, Foundation for Biotechnology Awareness and Education (FBAE), said, "The top courses in universities are never there to provide for the industry. Biotechnology probably is the first one. The industry does not require students with a very high academic background. It requires people who have competence in thinking, planning a product, a few great managers and the rest of the employees are worker bees. It requires a biotechnologist, a biochemist and so many other people put together. The industry captains have nowhere made it clear the kind of candidates they require and the qualifications they looking for. Let the industry come up with a white paper stating their requirements. We can modify a part of the curriculum to meet these requirements. Unless there is a serious dialogue between the industry and universities, we cannot improve the situation of talent crunch in the industry. Sudhir Kant, President, Millipore India, said, "The quality of teachers should be increased so that knowledge can be imparted effectively. But how many people really want to get into teaching these days? We are allowing too many biotech colleges to come up...quantity is increasing, but quality is lacking." Raghu MR, director, Best Biotek Research Labs, said: "We focus on practical hands-on oriented programs. What we have seen in the last five years is that the industry doesn't really expect very high-end things from the students. They want a very strong practical foundation and we are focusing on only that. Two major highlights of the discussion 1. Relevance of the curriculum 2. Current needs of the industry What are the things academia must do to ensure smooth flow of talent to the industry? Dr Jagadish Mittur, director, Monsanto Research Center: It is one versus team. Do we want one person who can handle everything as opposed to a team of lets say 10 individuals? Each one of these 10 will have extreme amount of in-depth knowledge in many of the subjects. I don't think one person can give us what we want. We look for a team of experts. It is good to have people who have had a little bit of exposure to other aspects of technology. They can bring in lateral thinking. We look for someone with a fundamental grounding. Fundamental aspects of the technology. We want someone who is able to communicate well what she/he knows. This is extremely important. It is very difficult for us to hire one person over the other. If this person has the capabilities, confidence will ooze out of the person. And we will not take much time in trying to scrutinize that person. Another thing is that this person has to have a long-term goal. We come across all kinds of students. They really have no idea as to what they want to become in life. I would rather listen to a student who has a long-term vision and who wants to contribute to solve the problems facing the country. And we do get people like that. That's what we would want. How do we meaningfully employ students? Dr Vijay Chandru, chairman, Strand Life Sciences: I am trying to understand the crisis better. I should not talk from the perspective of Strand Life Sciences. I don't think it generalizes well. If someone is trained both in theory and practice, you would actually get a much better product and we can go into several aspects of what the industry requires. And this is a challenge because we clearly need to modernize places like the IISc. I was appalled that there was no good microarray facility there. When we had to get scientists who understood these experimental techniques, we had to get scientists who were post doctoral people abroad and they have been our application scientists. There is no doubt it is very critical to have scientists with hands-on experience. Geeta Bali, Bangalore University: Ultimately it is practical training which will help the industry. What are the needs of the industry? We are yet to analyze this as the industry is diverse in nature. Can we tailor a program which is offered for 2 years and cut down to practically 8 months with the semester scheme. Within 8 months, can we train students and see to it that they are good in each of the subjects...it is difficult. The industry demands are growing at an enormous rate and practical training is lacking in most institutions as they have to deal with a large number of students and it is an expensive affair. I feel a closer interaction is required where BioSpectrum could help identify the industries and tell us what they requires in terms of theoretical and practical knowledge in students. We can try to incorporate the same as much as possible in the syllabus. It is impossible to train students in every branch of biotechnology. So let us at least focus on industries which are likely to recruit our students. We can improve the syllabus. We are always open for suggestions and we require inputs from the industry as to what can be incorporated in the syllabus. Dr PS Rao, Dayanand Sagar Institutions: The bottomline is to have a strong interaction between academia and industry. We need to know what the industry needs. Practical skills are lacking in biotech graduates passing out in huge numbers these days. Namratha Jagtap   ]]> <![CDATA[Promising Enterprises]]> https://biospectrumindia.com/news/95/1828/promising-enterprises.html https://biospectrumindia.com/news/95/1828/promising-enterprises.html Tue, 04 Sep 2007 15:29:00 +0530 New Page 1 Promising Enterprises BioSpectrum puts together a set of companies that have established their presence in the last one year or so. These companies have just started operations and are expected to make significant contributions to the biotech sector in the coming years. Actis Biologics Sanjeev Saxena, CEO California-based Actis Biologics Inc.'s Indian arm, Actis Biologics Pvt Ltd, a joint venture with entrepreneurs in India, is focused on target discovery of new molecules through collaborations and/or internal research or to in-license promising targets, then add value to the targets by accelerating the progression through the biopharmaceutical product life cycle while reducing costs by a significant margin. The Indian arm will be its hub for clinical research and development activities. Actis Biologics Pvt Ltd has incorporated under it ventures like Kohinoor Biotech to focus on a Ribozyme tech platform; Aum Life Sciences to focus on development of various Recombinant proteins and MABs; Mercury Biotech for development of genetherapy-based products; and Deep Biotech for the development of various immunotherapies using a novel Cytokine. Actis Biologics Inc., which was founded by Sanjay Saxena, an NRI, and Dave Toman, a molecular biologist and former scientist of Aventis as well as MD Anderson, has over 40 patents to its name. (AMRI) Dr Prasad S Raje, MD Albany Molecular Research Inc. (AMRI) is a chemistry-based drug discovery, development and manufacturing company, focusing on small molecule prescription drugs. AMRI recently announced the signing of a definitive agreement to acquire from the Runwal Group the assets of Ariane Orgachem Pvt Ltd in Aurangabad and Ferico Laboratories Ltd in Navi Mumbai. AMRI also obtained additional land in Aurangabad and plans to invest approximately $15 million to expand and upgrade its manufacturing capabilities over the next three years. AMRI's research center, Albany Molecular Research Hyderabad Research Centre Pvt Ltd. (AMRHRC), is located in Hyderabad and provides custom synthesis of scaffolds and building blocks, besides preparation of reference standards. A second laboratory for preparing larger amounts of pharmaceutical intermediates, starting materials and other compounds is also operational. EI DuPont India Balvinder Singh Kalsi, President and CEO DuPont will locate its first plant biotech research center outside the US at the DuPont Knowledge Center, in Hyderabad, India. Twenty DuPont crop genetics scientists have already begun working out of leased facilities near the site where the new Rs 100 crore DuPont Knowledge Center is to be built. By year-end, DuPont expects the number of crop genetics scientists on site to grow to nearly 100 as part of its $100 million reinvestment plan to increase its speed-to-market for new seed products. The plan includes adding more than 400 positions, mainly in research and development, at Pioneer. The new DuPont R&D center, the DuPont Knowledge Center, will be set up on 15 acres of land in the ICICI Knowledge Park in Hyderabad and is expected to accommodate more than 300 scientists and other employees. The Center is expected to be built and operational in less than 15 months. Aptuit Laurus Dr Satyanarayana Chaba, CEO Aptuit Inc. and Laurus Labs Ltd announced the formation of a new contract drug development company, Aptuit Laurus, in June this year. The JV will combine Aptuit's global offerings in drug development with Laurus' R&D and manufacturing expertise and newly built state-of-the-art facilities. The combined company will provide integrated services, technologies and manufacturing capabilities that span the entire drug development continuum. The new entity, Aptuit Laurus Private Limited, is based in Hyderabad with additional facilities in Visakhapatnam and Bangalore. Aptuit Laurus will initially provide services in early-stage drug discovery, medicinal chemistry, lead optimization, process development, scale-up and process optimization, safety and hazard assessment, formulation development and analytical chemistry. Aptuit has committed to invest approximately $100 million over the next four years to build upon Aptuit Laurus' development, manufacturing and informatics capabilities. BioCin Sanaa Ansari, CEO BioCin is a new Hyderabad-based company engaged in the manufacture of a range of high quality PCR reagents and tools for molecular biology research. BioCin's products are claimed to offer high throughput, speed, better sensitivity and yield offering a complete solution to PCR optimization. The company plans to develop a range of recombinant bio-pharmaceuticals through proprietary rDNA technology that will make a revolutionary impact in the area of human healthcare by enabling production of safe, pure and effective rDNA expression products. Evotec-RSIL Irfan Bandukwalla, Director Evotec-RSIL Ltd is a joint venture between Evotec AG and Research Support International Ltd (RSIL), a subsidiary of DIL Ltd for the design, synthesis and management of compound libraries. The joint venture combines Evotec's expertise in library design, synthesis, analysis, purification and project management with RSIL's science expertise. Evotec-RSIL Ltd has its facilities located in Thane. It has core expertise in high throughput synthesis of lead finding libraries, parallel synthesis of focused libraries, profiling of virtual libraries using proprietary software to select compounds for synthesis, in silico ADMET tools for compound selection and high throughput analysis of customer libraries. "Both RSIL and Evotec have an excellent and well established understanding and track record of providing services to the global pharmaceutical industry. Through our complimentary skills our customers will derive added values," said RSIL director, Irfan Bandukwalla. Frontier Tissueline Dr KM Cherian Frontier Tissueline is the bioscience unit of Frontier Lifeline Hospitals, Chennai, which was set up at TICEL Bio Park, Taramani, Chennai in July 2006. This unit undertakes advanced research in tissue engineering and biological cardiovascular implants. It also focuses on research and applications in stem cell, the making of viable scaffolds of autografts and umbilical cord blood storage. It also has capabilities in bioinformatics and computational biology. Frontier Tissueline has rare capabilities for the assessment of cardiac arrhythmias and electrophysiological studies and clinical application of stem cells for failing hearts in infants and adults. The research is funded by the Department of Science and Technology and Department of Biotechnology which suggested the entire idea of tissue engineering. Green Signal Bio Pharma P Sundaraparipooranan, director GSBPL is the vaccines manufacturing arm of Chennai-based Green Signal. Established in 2005, GSBPL, besides manufacturing, has also set up a R&D laboratory at TICEL Park, Chennai for carrying out clinical trials and pilot projects in seed development, vaccine manufacturing etc. The company plans manufacturing all kinds of vaccines, namely, Tetanus Toxoid, BCG, measles, DPT, and rabies. It also offers consultation on the growth and purification of proteins, lipids and carbohydrates; and on the drug susceptibility testing on bacteria and virus used for vaccine manufacture. The Wistar Institute licensed rubella seed stock developed at Wistar to two companies for commercialization and distribution of rubella vaccine in developing countries and Green Signal Bio Pharma Ltd is one them which will develop the vaccine for India. Huclin Research Ltd Dr Mahalingam Vasudevan, Executive Director Huclin Research Ltd (HRL) is a newly formed independent contract research organization (CRO) located in TICEL Biopark, Chennai. HRL provides a full array of clinical and analytical research services. Huclin has invested over Rs 7 crore for the bio-analytical and clinical beds at Ticel Bio-Park, the infrastructure facility for biotechnology R&D companies. Huclin also has plans to invest Rs 15 crore to develop trial centers across the country. The company has facilities to conduct clinical trial services, including design and conduct of Phase I to IV studies, protocol design and development, optimizing clinical trial design and patient population, designing case record form and development of patient information leaflets and quality of life forms, the release said. It will also provide project management services such as pharmacovigilance, safety reporting, post-marketing surveillance, site management activities, and statistical analysis. i3 Research i3 Research is a full-service CRO focused on oncology, central nervous system, and respiratory and infectious diseases. i3 Research provides specialized CRO services in all phases of research, all over the world, and has recently entered India. In India, i3 provides clinical research and data services offerings for India-specific and global trials. In addition to project management, monitoring, regulatory and quality assurance services, its data services offerings include data entry and programming, data management, biostatistics and statistical programming. INC GVK BIO Hyderabad-based INC GVK BIO is a joint venture between North Carolina based INC Research ), a therapeutically focused contract research organization with a trusted process for delivering reliable results and operating in 23 locations worldwide and GVK Biosciences (GVK BIO), a premier contract research organization, providing an integrated platform of research services across the pharma R&D value chain. The joint venture gives INC Research the capability to run full service, Phase I-IV clinical trials in India for its pharma and biotech customers, utilizing clinical research resources at GVK that are fully dedicated to INC GVK Bio India projects. The joint venture provided an opportunity for GVK BIO to gain access to INC Research's global reach while leveraging on its India-based clinical research capabilities. Operon Bio-Tech Ilanahai S, MD Operon Bio-Tech Pvt Ltd, a group company of Cetex Petrochemicals Ltd, is focused on biotech R&D and manufacturing. Cetex is the largest manufacturer of Methyl Ethyl Ketone (MEK) and Secondary Butyl Alcohol (SBA) in India. The company proposes to grow significantly into specialty and fine chemicals with strategic tie-ups with leading players. It's embarking on newer areas of research providing testing service to biotech, biopharmaceutical, food and other agricultural products. Its R&D division has very eminent scientist and expertise to discover and develop new innovative technology. Its diagnostic division has the capabilities to developed new molecular based diagnostic kits and reagents for human and veterinary diseases. It also planning for PCR and ELISA based diagnostics. LAXAI AVANTI Life Sciences Vamsi Maddipatla, CEO Integrated R&D outsourcing platform is a unique offering from LAXAI to enable BioPharma companies to establish, realize and scale their R&D efforts in India with close to zero capital investment. The company was incorporated in 2006. LAXAI AVANTI Life Sciences Pvt, Ltd. in India provides integrated drug R&D outsourcing platform with capabilities ranging from discovery to regulatory submissions backed by data management. LAXAI AVANTI Life Sciences is promoted by the LAXAI and the AVANTI group, one of India's reputed publicly listed corporations. Its presence in USA, Europe and India has helped to enhance the productivity and efficiency of BioPharma R&D programs globally to unprecedented levels of cost-effectiveness and quality by bringing together global expertise with the talent and the India advantage. The company is currently servicing its customers from its labs in ICICI Knowledge Park at Genome Valley. The data management and biostatistics centers are in Ameerpet and Somajiguda which is about a 100 seater center. It also has a training program in place to create talent required to service our customers. Premium Phytoceuticals Dr G Prakash, Director Premium Phytoceuticals Private Ltd is a contract research and manufacturing organization specializing in the field of natural products. Promoted by Dr G Prakash with over three decades of academic and industrial experience in R&D and manufacturing aspects in the broad field of phytoceuticals comprising of the high value APIs in the field of anticancers, antimalarials, dietary supplements includes standardized extracts , nutraceuticals, food ingredients , food colorants, spice oleoresins, essential oils and flavor ingredients. The company also undertakes preparation of reference standards, working standards, markers, process development and analytical method development. Premium Phytoceuticals is also involved in contract manufacturing services, regulatory support, marketing support and knowledge process outsourcing. Rheoscience â€“ India Dr. Swaminathan Subramaniam, Head, India Operations and Director, Business Development Rheoscience develops innovative therapeutics for diabetes, obesity and other serious metabolic disorders. Built around a selected group of leading metabolic diseases researchers from Novo Nordisk, the University of Copenhagen and the Center for Clinical and Basic Research (CCBR), Rheoscience is targeting areas of significant unmet medical needs. Rheoscience's lead product is the oral anti-diabetic drug Balaglitazone, which is in Phase III clinical trials for the treatment of type 2 diabetes, a disease that affects approximately 6 percent of the global adult population aged 20-79 years. Balaglitazone is being co-developed with Dr Reddy's Laboratories in India. "Our Indian presence will not only enable us to tap into Indian strengths in innovation, but will also allow us to use the capabilities of Indian contract research organizations for conducting effective R&D programs on behalf of biopharmaceutical companies that wish to take advantage of these resources but do not have the reach to do so effectively," said Dr Philip Just Larsen, CEO.   ]]> <![CDATA[RFCL leads change innovatively]]> https://biospectrumindia.com/news/95/7650/rfcl-leads-change-innovatively.html https://biospectrumindia.com/news/95/7650/rfcl-leads-change-innovatively.html Tue, 04 Sep 2007 15:24:00 +0530 New Page 1 RFCL leads change innovatively Inspiring Leadership: Core Team at RFCL Bottom Row (L-R): Rajaram Manjrekar, Subrata Mukherjee, Veena Kohli, Vijay Kumar Second Row (L-R): Vikram Sengar,Sushil Mehta, Maneesh K Gupta, Anand Sonbhadra Third Row (L-R): Ashok Jain, Nandlal Chaudhary, Top Row (L-R): Rajeev Gautam,V R Miranda,R Govindan CICI Venture's 100 percent leveraged buyout of the allied businesses of Ranbaxy Laboratories Ltd, now called RFCL, has in over a year made phenomenal progress. It reached an understanding with Wipro to transfer its BioMed business which includes employees, assets, liabilities, operations, customers and partnerships. The company's growth is almost double of the market growth rate. It has achieved all this by tackling its greatest challenge post-MBO--management of its human resources. Through out-of-box re-organization, re-structuring and re-strategizing efforts, RFCL today has evolved from a 16 plus layered organization into a flatter and transparent entity with only three management bands--Leadership, Operations and Execution. RFCL is present in three different markets through four SBUs--Rankem, Vetnex, Diagnova and Neosynth. While Rankem offers laboratory solutions to the research and scientific community, Vetnex products and services reach out to the animal health industry. Diagnova offers products and services for in vitro and in vivo diagnosis for improving human health care. Neosynth is an R&D outfit at RFCL which is building development and research capabilities for both Vetnex and Rankem businesses so as to make the businesses "holistic" and globally competitive. Sushil Mehta, managing director, RFCL, shares with BioSpectrum the company's future plans. How has the Wipro BioMed acquisition proved beneficial to you? While organic growth has been our mainstay during the last one year, RFCL is now poised to leap into a new growth phase, through inorganic growth. With mergers and acquisitions happening globally in the biomedical industry and with direct entry of many international players into India, the business requires game changers. We believe it is best for Wipro BioMed to team up with RFCL, a committed organization in the field of life sciences and laboratory solutions. Wipro BioMed brings to the table key principal relationships like Fujinon, Mindray, Promega, ICPBio, Vital Diagnostics, and Partec through its in vitro diagnostics, life sciences and medical endoscopy portfolio. The complementing of customer mix and product offering is almost 100 percent, with practically no overlap. Through this acquisition, Diagnova (the diagnostics SBU of RFCL) improves its market position from double digit level to high end single digit level in the $375 million market which is growing at 15 percent per annually. Diagnova is aiming for leadership position in the domestic market in next three-four years. Is this the first ever such deal in India? For RFCL it is the first inorganic growth initiative. In the industry, to the best of our knowledge it could probably be the first. What are your future plans? The future plans will be to accelerate our journey to be a globally respected company in the field of life sciences and laboratory solutions, providing quality products and services and creating winning relationships. Through organic growth for all our businesses we are looking at "Double the Market Growth" in domestic market to attain leadership position in next 3 to 4 years. To achieve this we have invested in people development and through empowerment created the best teams in respective industry domains. Expanding business relationships with niche principal partners will ensure that basket of offering is bigger day by day. Two years ago we were a company with three-four research/development scientists. Today this team has grown to 30 as of now. This team constitutes Neosynth which is the R&D platform for RFCL. This will drive our development capability, especially, for veterinary products beyond soft and semi-regulated markets. Exports will have to be accelerated to become a global player. We doubled our exports last year and will again double this year. However, honestly even this will not take us far as our export initiatives have begun only in the last two years and there is a huge and diverse market to be catered. Acquisitions in key international markets will drive the acceleration in building up a global life sciences and laboratory solutions outfit at RFCL. RFCL has made a good beginning, with Wipro BioMed acquisition, to its inorganic journey and is targeting more strategic acquisitions in the months ahead.   ]]> <![CDATA[Biotech's New Wave of Entrepreneurs A YEAR LATER]]> https://biospectrumindia.com/news/95/8375/biotechs-new-wave-of-entrepreneurs-a-year-later.html https://biospectrumindia.com/news/95/8375/biotechs-new-wave-of-entrepreneurs-a-year-later.html Tue, 04 Sep 2007 15:23:00 +0530 New Page 1 Biotech's New Wave of Entrepreneurs A YEAR LATER BioSpectrum, in August-September 2006, featured biotech's next wave of entrepreneurs. They were entrepreneurs who left cushy jobs to create a new path. When we featured them last year, they were confident, bullish, and thinking differently to establish themselves. A year later when we review them, it is heartening to note that almost all of them have made significant breakthroughs. RFCL is now poised to leap into a new growth phase, through inorganic growth by acquiring Wipro BioMed. Advinus has struck multi-million dollar drug-discovery deals. Biovel Life Sciences and PREMAS Biotech have launched their commercial operations. Navya Biologicals and Polyclone have got DSIR recognition. These are a few examples to illustrate the flavor. In the ensuing pages, BioSpectrum highlights the progress made by the entrepreneurs listed in 2006. Advinus Therapeutics Dr Rashmi Barbhaiya, CEO and MD It was a year ago in August 2006 that the drug discovery facility of Advinus Therapeutics in Pune was inaugurated by Tata Group chairman, Ratan Tata. An R&D driven company, promoted by the Tatas and Dr Rashmi Barbhaiya, Advinus Therapeutics has come a long way. The company has made significant stride since then. In November, Advinus and Veeda CR forged a strategic alliance to create an integrated drug discovery through Phase II platform. Advinus and Merck signed a drug-discovery collaboration in the area of metabolic diseases for discovery and development of novel therapies for two targets. Under the agreement, Advinus will get success based milestones of up to $74.5 million per target and royalties. In March 2007, Samaritan Pharma, a US-based company, entered into a services agreement with Advinus Therapeutics to advance its promising Alzheimer's compound through IND enabling studies. Its facilities expansion and renovation of the drug development center (220,000 sq. ft) in Bangalore have been completed and its cGMP kilo scale lab became operational. "Other than these specific milestones, Advinus Therapeutics has been able to increase its contract research business 3.5 folds (YOY) and over the last one year, it has entered into services agreement with various other biotech and pharma companies for doing IND enabling studies," said Dr Rashmi Barbhaiya, CEO and MD of Advinus Therapeutics.   Biovel Life Sciences P Sudhakera Naidu, MD and CEO, Biovel Life Sciences "Our company's state-of-the-art facility will provide the much-needed quality standards, economies of scale and timeline deliveries. Going by our infrastructure compliance and personnel capability, we are ready for CRAMS in the regulated markets," said P Sudhakera Naidu, MD and CEO, Biovel Life Sciences Biovel Life Sciences announced the commencement of its commercial operations. It inked a licensing agreement with US-based Dowpharma to produce Human Growth Hormone (HGH) using Pfenex Expression Technology, for the first time globally. Biovel Life Sciences is now ready to foray into contract research and manufacturing service (CRAMS). "We will provide expertise in basic research and manufacture biogenerics and biopharmaceuticals, besides fill-finish of vial/syringes," Naidu said. The company is also eyeing a small-sized European pharma plant for a possible acquisition. In order to be associated with the global pharma majors, Biovel opened an office at Atlanta. It has already bagged the global rights for manufacture and marketing of endocrinology products from a US major.   BiOZEEN Cherian Philip, Chairman BiOZEEN is an integrated engineering solution provider for engineering consultancy, training, research, design, and building of process equipment for biopharmaceuticals and biologics industries. As a consultant, Biozeen offers the entire gamut of engineering consulting services--from conceptualization to the commercialization of plant. Biozeen specialize in the design, delivery and validation of facilities providing turnkey solutions. It also offers practical training in the filed of industrial biotechnology among professionals and students. Biozeen has built extensive experience in design and manufacture of high end bioprocess equipment with exhaustive validation and documentation as per ASME and CFR compliance.       Kan Healthcare Vinod Wahi, president and CEO "As per our corporate philosophy, we believe in picking up aggressive targets for ourselves, in whatever we do, and go all out to beat the same," said Vinod Wahi, president and CEO. Kan Healthcare since its inception in 2006 has been a consistent performer. The company ended the year with a turnover of $1 million as against their planned figure of $0.5 million. This has been possible due to the company's unique concept of "scientific marketing" and excellent relationship and high level of trust among their foreign associates like The Binding Site, UK; IBL, Germany and Alfa Wassermann, Netherlands. The year also saw the company enter into two strategic tie-ups. It tied up with the Associates of Cape Cod (ACC), USA to offer LAL reagents for testing Endotoxin in the QC department of pharmaceutical companies. ACC is the first company to have received US FDA clearance for Gel Clot methodology, in addition to Chromogenic and Turbidimetric method which produces the highest sensitivity of 0.001 EU/ml. ACC has also passed on their other range of products in Glycobiology and Glycoanalysis as well as Fungitell for Invasive Fungal Infection The company shall also take over the marketing, sales and servicing of the entire range of Bender MedSystems, on exclusive basis, effective January 1, 2008. Bender MedSystems, Vienna is dedicated to cytokines for research purpose. In the current fiscal year, the company plans to achieve a target of $1.7 million with an even higher target of $3 million by the third year. "Our aim is to consolidate our existing business activities because there are enormous opportunities to excel in the market. We are simultaneously in touch with other world class organizations for a meaningful tie-up next year," Mr Vinod and Anuj Wahi added. Lifecare Innovations Dr Jitendra N Verma, managing director Lifecare Innovations is a company that has carved a niche for itself in the antifungal market with its portfolio of products that are world leaders in their own right. Ever since the launch of the Fungisome-Liposomal Amphotericin B (fungisome IV) in 2003, the product has been the company's star performer. "We have been achieving a consistent growth that is almost double that of the previous year, every year. We have been able to sustain that 100 percent growth this year too. That is why we call it Fungisome--the new gold standard," said Dr Jitendra N Verma, managing director, Lifecare Innovations (P) Ltd. It has a success rate of 90 percent and a toxicity of near zero owing to its unique suspension medium and lipid composition. Commenting on the success of products in the company's portfolio, Dr Verma said, "We haven't done aggressive marketing for our products, yet we have been getting good enquires for our products from everywhere in the world. We are the only country in the world to have a basket of liposomal products. To meet this international demand we are now developing a state-of-the-art manufacturing facility in Biotech Park, Lucknow." The company also has several awards to its credit. It was honoured by DBT for its Psorisome gel and fungisome gel in 2006 alongwith a national award by DSIR (Department of Science & Industrial Research, Ministry of Science & Technology, Government of India) National Award 2006 for R&D efforts in industry for fungisome IV. "The company is now planning to come up with dermatology and oncology-based products too," added Dr Verma. The company is 70 people strong. The company also signed an agreement with a CSIR South Africa led consortium to do concurrent clinical trials for TB. The company is already working with PGI Chandigarh for the sustained release of anti TB drugs. Navya Biologicals Dr KR Rajyashri and Vinay Konaje, founders Navya Biologicals has shifted its operations from Bangalore to Dharwad. This strategic shift is owing to what it terms as "inclusive capitalism"--taking cutting edge biotechnology research to B and C class cities of India and nurturing talent there. The company is looking to close the ongoing financial year with revenues of approximately Rs 2.5 crore. It is looking to aggressively expand its operations beyond the technology incubator that it has leased at the UAS-Dharwad. The company is setting up its own research and process development facility in Dharwad and has acquired land for the purpose. Construction of the new facility is slated to begin in October this year and the facility should go on stream by April 2008, according to the promoters. It has also recently attracted SBIRI funding for development of novel technologies/product and hopes to file five-six PCTs through this program over the next 18 months.   Polyclone Bioservices Naveen Kulkarni, CEO Bangalore-based Polyclone Bioservices, which provides bioservices in genomics and drug discovery to the life sciences industry, has made progressive strides in the last one year, the DSIR recognition as an R&D company being the major highlight. The company's other achievements include setting up a Nucleic Acid Testing (NAT) facility. Enhanced analytical specificity and sensitivity are the major advantages to nucleic acid testing. Polyclone with its expertise in molecular biology, intends to provide services to professional diagnostics outfits, thereby adding value to their current portfolio. In May 2007, Polyclone announced the launch of its first product Eprime. Eprime is a software application to design primers for qualitative real time PCR studies. It designs PCR primers and probes for SYBR green, Taqman and Molecular Beacon studies and assays. "In the first year, Polyclone is looking to install about 50-100 licenses in India and is jointly working out the pricing models with Eppendorf--both for domestic and global markets," said Naveen Kulkarni, CEO, Polyclone Bioservices. Eprime is sold by Eppendorf along with the latter's PCR systems. In May 2007, Polyclone Biosciences bagged the DSIR (Department of Scientific and Industrial Research ) certification for its laboratory located within the Dharward University.   PREMAS Biotech Rajeev Soni, President and COO PREMAS Biotech was incorporated in November 2005 and, subsequently, it took nearly 16 months to set up the laboratories in Manesar, one of the most structured and well managed industrial towns of Haryana. Some of the key achievements include setting up state-of-the-art laboratories for research in molecular biology and biotechnology with requisite support facilities; filing of provisional patents for applied research technologies such as diagnostic technology for infectious diseases and proprietary vectors for protein expression in bacterial, yeast and mammalian cells; hiring of scientific personnel and securing contracts from companies of national and international repute. The company has started its commercial operations in March 2007, and currently it is in the process of serving four customers for drug discovery services and products. The facility for the manufacture of these specialized enzymes for research purposes would be fully operational by December 2007. It has the capabilities to produce enzymes and proteins up to the scale of 1500 liters for research purposes only. The facility would be available for contract manufacturing for companies interested to produce proteins required for drug discovery research. The company has important project, Applied Research for Technology Transfer (ARTT), in the pipeline focused on several areas of molecular diagnostics, proprietary vectors and novel bio-therapeutics.                     ]]> <![CDATA[BIOPRODUCT]]> https://biospectrumindia.com/news/95/2027/bioproduct.html https://biospectrumindia.com/news/95/2027/bioproduct.html Mon, 06 Aug 2007 15:26:00 +0530 New Page 1 Sartorius launches BioWelder, BioSealer Sartorius has launched BioWelder and BioSealer, the new products for connecting or disconnecting of thermoplastic tubing in biopharmaceutical manufacturing processes. The introduction of BioWelder and BioSealer is a further milestone in the company's implementation of innovative and efficient disposable process solutions for the industry. Both devices incorporate proven technology provided by Wave Biotech Switzerland who recently formed a strategic alliance with Sartorius. Featuring the ability of handling a broad range of tubing diameters from 1/4" OD to ¾" OD in various thermoplastic tubing types, BioWelder and BioSealer allow flexible implementation into disposable manufacturing processes. Fully automated operation combined with short cycle times enables users of disposable bag assemblies to handle the interfaces between the process steps conveniently, without compromising process sterility. The thermal welds and seals produced by BioWelder and BioSealer ensure an extraordinary level of stability and guarantee sterility. BioWelder and BioSealer will be integrated in Sartorius' Gammasart BioSystems line of disposable sterile fluid handling products. For details, contact: biju.jacob@sartorius.com   BioTek unveils multi-detection microplate reader BioTek Instruments has unveiled the world's first true multi-detection system capable of performing an unlimited number of microplate-based assays â€“ the new patent-pending Synergy 4 multi-detection microplate reader. The Synergy 4 is the first multi-mode reader that combines both filter-based and quadruple monochromator-based fluorescence detection technology. In addition, Synergy 4 includes fluorescence intensity, luminescence, fluorescence polarization, time-resolved fluorescence, and UV-visible absorbance for endless flexibility in current and future microplate-based assay choice. Filter-based fluorescence technology provides optimal light filtering and purification for the best sensitivity. The inherent design of filter systems also provides fast wavelength switching and higher read speeds. On the other hand, the quadruple monochromator-based fluorescence technology offers flexible wavelength selection, true spectral scanning, reduced background noise and increased convenience. The combination of the filter and monochromator systems in one unit means that microplate assay choice is no longer restricted by the technology of the microplate reader. For details, contact: amourettix@biotek.com   Bio-Rad debuts Mini-PROTEAN Tetra Cell Bio-Rad's new Mini-PROTEAN Tetra cell is the next-generation mini cell for 1-D vertical electrophoresis. With patented clamping frame, the Tetra Cell 1-D provides its user with two running modules, accommodating one to four handcast or precast gels allowing it to run mini gels in less than an hour or 2D gels in less than a day. The system is also equipped with patented sample loading guides that allow the Tetra Cell 1-D to prevent skipping or repeated loading of lanes. For details, call 91-124-4029300   Invitrogen introduces Qubit The Qubit Quantitation Platform is the most sophisticated quantitation assay for benchtop experiments. The quantitation system is a combination of sophisticated, accurate and highly sensitive fluorescence-based quantitation assays and the user-friendly fluorometer. The Qubit fluorometer is designed to work seamlessly with the Quant-iT assays for DNA, RNA and protein quantitation. It features state-of-the-art optical components, sophisticated data analysis and an intuitive user interface. The result is an easy method to obtain much more accurate and sensitive quantitation than can be obtained with UV absorbance assays, increasing the reseachers' confidence in taking sample to downstream applications. Quant-iT Assay Kits use advanced fluorophores that become fluorescent upon binding to DNA, RNA, or protein. This specificity results in more accurate assays than with UV absorbance readings, because Quant-iT Assay Kits only report the concentration of the molecule of interest (not contaminants). They are routinely used for sequencing genomic DNA samples, cloning experiments, microarray experiments, real-time PCR samples and northern and western blots. For details, visit www.invitrogen.com ]]> <![CDATA['Agilent's India campus is one of the largest']]> https://biospectrumindia.com/news/95/2413/agilents-india-campus-is-one-of-the-largest.html https://biospectrumindia.com/news/95/2413/agilents-india-campus-is-one-of-the-largest.html Mon, 06 Aug 2007 15:22:00 +0530 New Page 1 'Agilent's India campus is one of the largest' - Venkatesh Valluri, President & Country GM, Agilent India Agilent Technologies is on the leading edge in bio-analytical measurement business providing application-focused solutions that include instruments, software, consumables and services enabling customers to identify, quantify and analyze the physical and biological properties of substances and products. Agilent caters to the industry with microarrays, microfluidics, gas chromatography, liquid chromatography, mass spectrometry, software and informatics, and consumables and services. Venkatesh Valluri, President and Country General Manager of Agilent India, elaborates on Agilent's presence in India and the initiatives to strengthen the company's presence in the country. Can you give an overview of the uptake of Agilent products in the life sciences segment in India? The mission of our LSCA business is to contribute to the quality of life by providing measurement solutions to the life sciences and chemical analysis industries. Agilent's LSCA Division is a leading supplier of instruments, software, supplies and services to the life science and chemical analysis markets. These products enable customers to identify, quantify, analyze and test the atomic, molecular, physical and biological properties of thousands of substances and products. Customers in the chemical, environmental, pharmaceutical, biotech, academic and government sectors use these products extensively. Today, Agilent has a leadership position in the market for these products and solutions. It continues to bring in the latest technologies that are helping the Indian industry compete globally. How do you intend to strengthen Agilent's life sciences division in India? Agilent is extremely committed to India and the announcement of setting up an R&D center in Bangalore in the recent past is the testimony to our commitment. This decision to initiate R&D activities in the country reflects our confidence in the talent pool and growth opportunities here. We will continue to focus on providing cutting-edge technology services to our customers and partners. The Bangalore center will complement other global Agilent development teams and will work towards innovations that are applicable to both India and global markets. Will there be any specific product launches for the Indian life science market this year? Agilent will continue to bring in state-of-the-art technology into India. Our recent launches in the Mass spectrometry area which included QQQ (triple Quad) and QTOF LS/MS systems are a demonstration of this focus. We will continue to bring in new technologies and products that would enable the growth of the Indian industry. How do you plan to increase your customer support services in India? India is one of the fastest growing markets for Agilent and we will be taking all steps to strengthen its leadership position in the Indian market. Our recent investment to set up a world class Center of Excellence (CoE) in Bangalore is a testimony to this fact. Today, we have presence in all major metros of India. We will continue to expand our presence in the next tier cities where the biotech, pharma and the chemical analysis industries are present. Our expansion plans are essentially geared towards providing world-class service and support to our customers. We will continue to demonstrate the new technologies that are being worked upon by Agilent to our customers and partners. Recently, Agilent opened its China headquarter campus. Are there any similar plans for India? Agilent in India is in the process of building a campus near Manesar in Haryana. Spread over 10 acres, this will be one of Agilent's largest campuses worldwide. With operations in India now having reached a critical mass, investing in a state-of-the-art campus was the next logical step. In keeping with our strong commitment to India, the campus will house employees involved in research and development, engineering support and financial services for Agilent entities worldwide. How do you plan to increase the distribution of your products and services in India? Agilent is a high technology company providing high-end solutions to our customers. It is important that the products we sell are well supported. Our attempt to expand and serve the large Indian market depends on qualified personnel and a robust service and support structure. Our strategy for expansion is based on the simple premise that we continue to provide world-class technology and support. To do this we will continue to invest in training our workforce, channels and customers. The geographical reach is also important and therefore we would expand our presence to the next tier cities in the coming months. Hasthana Rajappa   ]]> <![CDATA['The demand for our product is growing']]> https://biospectrumindia.com/news/95/2838/the-demand-for-our-product-is-growing.html https://biospectrumindia.com/news/95/2838/the-demand-for-our-product-is-growing.html Mon, 06 Aug 2007 15:21:00 +0530 New Page 1 'The demand for our product is growing' - Ron Van Dijk MD, West Pharmaceutical Services-APAC NYSE-listed West Pharmaceutical Services (WPS) provides standard-setting systems and device components for parenterally administered medicines. WPS applies proprietary materials science, formulation research and manufacturing innovation to advance the quality, therapeutic value, development speed and rapid market availability of pharmaceuticals, biologics, vaccines and consumer healthcare products. The company has shifted focus to provide greater support to its Asia Pacific customers. Some excerpts from an interview with Ron van Dijk, Managing Director and Vice President, WPC, for the Asia Pacific region. How would you describe the demand of your products in Asia Pacific? Asia Pacific is home to about half of the world's population and there is an increasing local demand for pharmaceuticals. As far as injectable pharmaceutical manufacturing goes, global manufacturers are setting up facilities in Asia, local manufacturers are increasingly becoming cGMP compliant and all seek the support of a reliable supplier of quality pharmaceutical closures. WPS is a partner to these manufacturers and supports the pharmaceutical growth in Asia Pacific. The demand for our products is growing significantly in Asia Pacific and our challenge is to continue to support customers with our expertise built over many years in achieving their local and global goals. Who are your big clients? WPS is servicing a wide spectrum of customers, ranging from new domestic manufacturers to multinationals. Some of the major manufacturers served in the Asia Pacific region are Serum Institute of India, Ranbaxy Laboratories, Biocon, Dr Reddy's Laboratories, Sino-Swede Pharmaceutical Corporation, GE Healthcare, B Braun, Becton Dickinson, Baxter Healthcare, PT Biofarma, LG Lifesciences and Mayne Pharma (now being part of Hospira). What is the capacity of the product facility in Singapore? The production capacity is very much dependent on the product range. We manufacture a wide range of product in different designs and sizes, and the product range changes yearly (up to a few billion units per annum). What are your plans for the Singapore operations? I am pleased with the existing infrastructure in Singapore. The WPS Singapore operation will initially service as a hub to expand our initiatives throughout the Asia Pacific region. We also plan to further develop the WPS Singapore facility to produce more value added products to assist manufacturers in this region in meeting the regulations internationally. We are therefore starting an expansion program for the WPS Singapore facility in which the production capacity will be increased. We are investing into a plant extension, new equipment and are recruiting additional employees to support the growth we experience. All these initiatives will enable us to play a major role in supporting the pharmaceutical industry in Asia Pacific. Which markets do you address from your Singapore plant? Our WPS Singapore facility supplies most of the products to the Asia Pacific region. Although we supply some products to the US and Europe, the percentage is decreasing as WPS Singapore is focusing to support customers in the Asia Pacific markets. Do you have any expansion plans anywhere else in Asia? Yes, last year the WPS Corporation announced an investment of $80 million to establish two manufacturing facilities in China, which will be completed by 2011. We will continue to review appropriate investment initiatives in other countries in the future in order to support the growing demand for pharmaceutical closures in this region. Nandita Singh   ]]> <![CDATA['China, India are our new markets']]> https://biospectrumindia.com/news/95/2233/china-india-are-our-new-markets.html https://biospectrumindia.com/news/95/2233/china-india-are-our-new-markets.html Mon, 06 Aug 2007 15:11:00 +0530 New Page 1 'China, India are our new markets' - Duncan Ross, CEO, Atcor Medical Sydney-headquartered AtCor Medical develops products for clinical use that can non-invasively assess the physiological status and the functioning of the cardiovascular system in humans. "Significant opportunity lies in the Asia Pacific region," informs Duncan Ross, CEO, AtCor Medical, in an interview with BioSpectrum. Some excerpts. Can you elaborate on Sphy gmoCor's unique technology? How is it different from other similar diagnostic systems? AtCor Medical manufactures and markets the SphygmoCor Cardiovascular Management System products and services for the early detection and management of cardiovascular disease. The key attribute of the SphygmoCor system is that it measures central aortic blood pressure or blood pressure at the heart, and provides information regarding the physical status and function of the cardiovascular system through a relatively simple non-invasive test that can be conducted in a doctor's office. Prior to SphygmoCor's development, central blood pressure and other key heart function parameters could only be obtained through more risky, expensive and time consuming invasive methods with significant inconvenience and discomfort to the patient. SphygmoCor is FDA cleared for measuring central blood pressure non-invasively. Two major cardiovascular outcome studies - the CAFE study and USA National Institute of Health-funded Strong Heart Study - established the importance of central blood pressure in assessing cardiovascular risk and the effects of pharmacologic therapy on clinical outcomes. Both studies showed central blood pressure to be superior in predicting outcomes to the standard brachial/arm cuff pressure measurement method. Can you give a brief outline of the company's present product portfolio and its product line-up for the future? The SphygmoCor system assesses the central blood pressure effects of changes in arterial stiffness, which is a primary driver of general cardiovascular risk such as heart attacks, strokes and heart failure. The key heart function parameters that SphygmoCor provides are blood pressure at the heart, timing of the heart pumping cycle, and measures of arterial stiffness. It has a comprehensive database of population 'normals' to enable physicians to assess cardiovascular status. We provide clinical, technical and data management support for the pharma and biotech industries. The ability to assess cardiovascular risk and disease in patients, both cost effectively and painlessly, has significant benefits for clinical practice and for patients' health. A major factor that will contribute to AtCor Medical maintaining its innovation and leadership position in the non-invasive cardiac measurement market is the Australian government's recent $1.6 million grant to AtCor through its Commercial Ready Program. The grant will fund, on a dollar for dollar basis, development of SphygmoCor to enhance adoption in the clinical practice market. AtCor's objectives include developing new non-invasive cardiovascular parameters, expanding the range of systems, and simplifying use for medical practitioners. What are the company's growth prospects in the next five years? We expect substantial growth over the next five years. AtCor has a solid base of over 1,000 systems installed globally serving researchers, clinical specialists and drug developers. In the US alone, AtCor is resident in 14 of the top 20 hospitals as noted by US News and World Report. In the near-to-mid-term, economic, socio-political and clinical factors will drive at an increasing rate SphygmoCor's adoption in the drug development space. Unlike other device companies that rely solely on basic research sales prior to moving into full clinical adoption, AtCor has developed a rapidly growing biotech pharma and biotech trials business. This will generate significant cash over the short to mid term and help fund AtCor's development of the clinical market. To insure proper infrastructure to execute and implement our plans, AtCor in the 19 months since our IPO has assembled talented and highly motivated commercial teams in the US, Europe and Asia. We expect substantial growth from the infrastructure currently in place. We have appointed a number of new distributors in key European and Asian markets that will further leverage our current commercial investment. What is the prevalence of cardiovascular diseases and in what way are you positioning the company to tackle the cardiovascular diseases? Cardiovascular disease is the leading cause of death in the developed world. Its frequency is increasing due to obesity and ageing. The US alone has over 70 million people with some form of cardiovascular disease, which is the cause of approximately one million deaths per year. Cardiovascular disease is also the major cause of death in patients suffering diabetes and renal disease. With a $2 billion potential global market ($1 billion potential US market) and the only FDA cleared device for measuring central blood pressure non-invasively AtCor Medical's SphygmoCor has the opportunity to transform the assessment and management of cardiovascular disease. From which countries do you see a surging demand for your products? We see this as a global growth play in all major markets. Currently, we are only scratching the surface of the global $2 billion potential for our products. With our well established market presence in the US and Europe, the Asia Pacific region with its ever increasing incidence of cardiovascular disease and less than 10 percent of our installed base represents a significant market development opportunity for us. China has undergone a health transition in line with its economy, with cardiovascular disease and stroke supplanting infectious diseases as major causes of death. According to the American Heart Association, there are 50-60 million high blood pressure patients in China, and coronary heart disease is the leading cause of death in urban areas. In India, surveys indicate about 950,000 annual deaths from cardiovascular diseases, but the actual figure may be at least twice as large. China and India are effectively new markets for AtCor. Together, these countries have approximately 40 per cent of the world's population. Increasing affluence has led to a demand for higher standards of health management and greater focus on preventative medical care. Do you see India as an important market? If yes, why? India is the world's second most populous country, and has the world's highest incidence of diabetes and an increasing incidence of hypertension. So, yes, India represents a largely untapped market opportunity for AtCor Medical. With the recent signing of a sales distribution agreement with Vaso-Meditech, which is headquartered in Chennai, we have high expectations of increased sales in India. Hasthana Rajappa   ]]> <![CDATA[Best Biotek plans to establish a biotech finishing school]]> https://biospectrumindia.com/news/95/5445/best-biotek-plans-to-establish-a-biotech-finishing-school.html https://biospectrumindia.com/news/95/5445/best-biotek-plans-to-establish-a-biotech-finishing-school.html Mon, 06 Aug 2007 15:04:00 +0530 New Page 1 Best Biotek plans to establish a biotech finishing school Since its inception, Best Biotek has successfully trained over 3000 graduates, postgraduates and has guided a number of MPhil and PhD candidates in their research projects in various streams of biotechnology. Today it has emerged as a major corporate training center for the biotech industry. Best Biotek Research Labs is an ISO 9001-2000 certified biotech training and research center. It was established in 2001 with an aim to meet the growing demands and needs of the biotech industry for professionally trained candidates. Over the years, Best Biotek has grown and has become a one-stop center for learning hands-on skills in biotech, bioinformatics and clinical research. It also offers placement assistance and counseling for careers including self employment and advanced studies in life sciences. Another salient feature of Best Biotek is that it provides customized corporate training covering all relevant topics from product development to commercialization, including statutory documentation for setting up biotech firms. The institute also conducts workshops, seminars and short-term programs in contemporary areas of biotechnology for corporate and academic participants. Fee structure The fee structure and the duration of the various programs are as follows Course Duration Fee PhD Research Program 3 years Rs 6,00,000 PG Diploma in Biotech Business Management 1 year Rs 1,75,000 PG Diploma in Biotechnology 1 year Rs 75,000 Advanced Diploma in Biotechnology 210 days Rs 40,000 Advanced Diploma in Pharmaceutical Biotechnology 210 days Rs 40,000 Advanced Diploma in Clinical Research (weekends) 6 months Rs 60,000 Programs Best Biotek's programs are categorized into basic level, diploma level, advanced diploma level and research programs. It also offers on-job training programs, proficiency programs and PhD and M.Phil programs in biotechnology and environmental sciences. The disciplines of training include clinical research, industrial microbiology, enzymology and protein purification, immunotechnology, molecular biology and genetic engineering, fermentation and down stream process, general biotechnology, plant tissue culture, DNA fingerprinting, agricultural biotechnology, higher end training RAPD analysis and HPLC and GLC training and agro bacterium mediated gene transfer. The duration of proficiency courses is 10-15 days and the fees ranges from Rs 4,500-Rs 6,000. The fees for 15-day on-job training courses is Rs 3,000. The fees for courses in Applied Techniques (7-21 days) is in the range of Rs 7,000-Rs 18,000. The duration of Bioinformatics courses is anywhere between 30 days and a year, the fees for which can be anything between Rs 7,500-Rs 60,000. SAS Programming courses are offered at Rs 20,000 and Rs 35,000 for course durations of 30 days and 60 days respectively. Best Biotek has an independent R&D, which has developed many products. Its consultancy profile includes product identification and development, protocol development, production and supply of kits for educational institutions, market research and feasibility reports and consultancy for setting up biotech labs, research institutes and colleges. Best Biotek currently has two centers in Hyderabad and one in Nagpur. It plans to expand its network to 10 centers in India by the end of this year. Best Biotek will soon be relocating from its current 2,500 sft facility in Jayanagar in Bangalore to a 10,000 sft facility in Nagarbhavi, Bangalore. Best Biotek has an ambitious plan of establishing a biotech finishing school in the future. Namratha Jagtap ]]> <![CDATA["The CT industry is expected to touch $1.2 billion by 2010"]]> https://biospectrumindia.com/news/95/1748/the-ct-industry-is-expected-to-touch-1-2-billion-by-2010.html https://biospectrumindia.com/news/95/1748/the-ct-industry-is-expected-to-touch-1-2-billion-by-2010.html Mon, 06 Aug 2007 14:57:00 +0530 New Page 1 "The CT industry is expected to touch $1.2 billion by 2010" -Prof SK Gupta, Dean, ICRI, New Delhi How did you come up with the idea of such an institute? India is recognized as a hub but trained professionals are not there. There are institutes like ICR (UK) or ACRP (US), but nothing as such in India. The clinical trial industry is expected to touch $1.2 billion by 2010. There have been a lot of national and international reports in which it has been mentioned that we will need around 20,000 -50,00 clinical research professionals. So the need for professionals was felt and that's how the institute came into existence. How do you foresee growth in clinical research in a country like India? India is on a rise as far as clinical trials are considered. There are around 264 clinical trials registered (Indian as well as global) and many more are being conducted. India its developing its own molecules so those clinical trials are done, but apart from this there are several multinational companies conducting clinical trials. Looking at the statistics, five years back there were 10 CROs. Today there are more than 150. Here is a vertical growth. What kind of students does the institute take up? There are broadly three categories of students- MBBS and pharmacy graduates, life science graduates, graduates from alternative system of medicine like Ayurveda, dentists. The students should have a life science background to understand how a drug works, how is it developed and absorbed in the body and its adverse effects in the body. Give us an overview of the selection procedure. An interview and written test through which candidates are selected. Batch size varies from plakhe to plakhe. In Mumbai the pharmaceutical industry is much more developed and awareness level is very high and therefore we expect around 200 students there. Under the prog we also give them a PG diploma in Pharmaceutical management simultaneously to give them enough insight to conduct clinical trials, how to manage, how to do the financial bidding, how to monitor them. Are you looking at any collaborations? We are looking at collaborations with the DBT (Department of Biotechnology), Gujarat government, but it is not easy to bridge the gap between the mindset of the government and the industry. Why do you think India is experiencing a rise in clinical research? It is mainly because of a diverse patient population and fast track registration. So the drug development has a life span of 12 years in the US. It is almost half here, thereby cutting down on the cost. Students speak BioSpectrum spoke to Himanshu Tandon and Priyanka Chamoli, both of whom passed out from the first batch of MSc (CR) + MBA (Marketing) Course at ICRI in 2006 and are working in the field. Where are you working currently? HT: I am working as a clinical data programmer with i3 statprobe. PC: I work in Panacea Biotec as research associate (quality assurance) - clinical research department.   What was your educational qualification when you took up this course? HT: I was a life science graduate, B.Sc (General). PC: When I joined ICRI in year 2004, I was a fresh graduate in science with physics chemistry and maths as my subjects in graduation.   Were you aware of clinical research as a career before you took up the course? What other courses were you considering before you took admission? HT: At that point of time I was having an idea about this career through some magazines like Business World and Business Today. At that time I was considering an MBA course for my future. Now I feel I took a better decision. PC: I was planning to go for MBA or MCA. Then I got to know about ICRI's course in clinical research. Frankly, I didn't know much about it but after I visited ICRI, I found the course very interesting and challenging. Today I realize that my decision was right.   Now that you are a clinical research professional, how relevant do you think the training in this field has been for you? How has it helped you get that extra edge? HT: Being a clinical research professional I can say that training and course contents provided by ICRI were really useful and relevant. The professionals already in the industry had learnt through their experience but we got all those things from books and training. With this knowledge and some experience, ICRI students are very competitive and successful in the industry. PC: While working in the clinical research industry the training and guidance i got in this field through ICRI helped me a lot. Despite being a fresher, I know many things that even a person in the industry is not confident about. I started my career not by starting learning things like others, I started my career directly by applying my knowledge.   How good do you think is the career in terms of growth and pay package? HT: In terms of growth, this is a fantastic career because there is demand supply gap. The growth rate is very high when compared to other careers because of lakhs of educated and trained candidates. The starting pay packages in this field are between Rs 1.8 to 3.5 lakh per annum. PC: There is enormous growth in this field. The only requirement is dedicated and hard working professionals and if you have good experience, money is never an issue.   Now that you are in the industry, do you think that more such professionals are needed to meet the growing demand and how do you see its future? PC: The future is very bright because this field is not yet saturated. The clinical research industry is growing and the number of experienced professionals in not adequate to meet the requirements. The industry is searching for more and more professionals. The coming years will bring a boom in this industry as all the MNCs are entering India for clinical research. So it is the right time in my opinion to choose clinical research as your career. Shalini Gupta     ]]> <![CDATA[Clinical research is the buzzword]]> https://biospectrumindia.com/news/95/3859/clinical-research-is-the-buzzword.html https://biospectrumindia.com/news/95/3859/clinical-research-is-the-buzzword.html Mon, 06 Aug 2007 14:53:00 +0530 New Page 1 Clinical research is the buzzword If you are a life science graduate looking for a challenging and rewarding career, one in the field of clinical research should be your first choice. We tell you why... India is increasingly being recognized as a quality player and a preferred partner for global clinical trials. This can be further attributed to a large and diverse patients' pool, availability of medical, pharmacy and science graduates, excellent infrastructure facilities, comparative cost advantage and changes in the regulatory framework. A promising industry According to McKinsey Report, the global clinical trial outsourcing to India in the pharmaceutical industry is estimated to reach around Rs 5,000 crore by the year 2010, and there will be requirement of approximately 50,000 clinical research professionals. Analysts are already projecting that the total clinical research spending in India will increase by more than 30 percent annually through 2010. A study by Ernst & Young indicates that the total market value of clinical research activitie s performed in India is expected to grow to around $1.5-2 billion. Many pharmaceutical and clinical research organizations have already come forward to unlock the vast potential that India has, and are conducting clinical trials in India. Thus, there is expected to be a huge demand for qualified and trained clinical research professionals. Courses for student The Institute of Clinical Research (India), ICRI offers various programs in clinical research. This includes a two-year MSc in clinical research program in Mumbai, Delhi , Ahmedabad and Bangalore. The course with its exhaustive syllabus elaborates on the essential aspects of clinical research. Students can choose to complete their course at the Cranfield University, UK A Postgraduate Diploma in Pharmaceutical Management (PGDPM) is integrated into the program that provides strong functional skills and the ability to integrate and apply them in different management settings. The degree is awarded by Cranfield University UK and is not recognized by AICTE/UGC or any other State Act. Besides this, the institute also conducts 1 year part time PG diploma courses in clinical data management and clinical research. Career prospects There are various stages in the making of a clinical trial and hence one can look forward to a range of careers in the field. One might work as a project manager, a data manager, an investigator or oversee the business development in major pharmaceutical companies, hospitals, CROs and biotech companies. ICRI students have had almost 100 percent plakhements in most of the renowned pharmaceutical companies including Siro-Clinpharm, Cipla, Cognizant, Pfizer, IRL-Synexus, Clinirx, iGATE, Quintiles and Ranbaxy to name a few. Remuneration As in any other career, salary packages are based on individual merit, a student's academic background and a rising learning curve. Salaries start at Rs 1.5 lakh per annum to over Rs 15 lakh per annum for professionals with less than five years experience. Clinical Research, therefore, promises to be an interesting career option in India. At ICRI, the average salaries have been Rs 1,80,000 pa and it is anticipated that this year's average will be double based on the demand-supply gap existing in the industry.   ]]> <![CDATA[Bridging skill gaps for BT industry]]> https://biospectrumindia.com/news/95/3850/bridging-skill-gaps-for-bt-industry.html https://biospectrumindia.com/news/95/3850/bridging-skill-gaps-for-bt-industry.html Mon, 06 Aug 2007 14:40:00 +0530 New Page 1 Bridging skill gaps for BT industry Shubhlata Sharma, Senior Scientific Officer (shubhlata@dbt.nic.in) & Dr Suman Govil, advisor (suman@dbt.nic.in), DBT, Ministry of Science & Technology. The DBT has taken initiatives to ensure that the biotech industry gets quality manpower. The Indian biotech industry is expected to reach $5 billion by 2010 from $2 billion in 2006 (Assocham and BioSpectrum) and $25 billion by 2015. The industry and policy makers are ambitious to clock $40 billion by 2015. At present, half of biotech industry's revenue comes from exports and there is scope for expansion of domestic market. India offers competitive edge due to large domestic market, availability of skilled manpower at relatively low cost and strong biomanufacturing skills. Owing to its strengths in computing software and services in data management, India is the preferred hub for clinical data management. The growing pressure on pharma industries to reduce the cost of new products has created new opportunities for contract research, manufacturing and clinical trials in countries such as India and China. Although India's share is less than two percent of the $50 billion global pharma market, it is still the preferred destination for contract manufacturing due to the presence of 800 GMP compliant manufacturing units in the country. At present, the domestic contract research sector is around Rs 480 crore and is expected to grow at 80 percent, according to industry estimates. Indian clinical research organizations (CROs) are currently growing at a rate of 40-50 percent and are shifting their thrust from bioavailability and bioequivalence studies to phase I â€“ IV clinical trials and data management. Life science analytical instruments account for 26 percent share of the global market of $31 billion, which is approximately $8 billion. The Indian analytical instrument business is growing at a growth rate of 20 percent and there is tremendous scope for growth provided we match international standards. For the first time, India grew more Bt cotton (3.8 million hectares) than China (3.5 million hectares) and moved up the world ranking by two places to number five in the world of biotech crops, overtaking both China and Paraguay (Global status of commercialized Biotech/GM Crops: 2006 by Clive James ). Biotech based business being knowledge intensive, there is bound to be a spurt in consultancy organizations, which could provide services such as technology evaluation, transfer and commercialization, business planning, work force training, identifying opportunities for global collaboration, merger or acquisition, working of innovative terms of payment etc. to the existing and aspiring investors and entrepreneurs. The growth in the sector is bound to create requirement for skilled human resource. BioSpectrum in association with ABLE conducted a survey of top 20 biotech industries regarding manpower availability, requirement of manpower as well as quality. The industries from various sectors were selected to understand the mood and sentiments of the industry. The analysis has shown that demand is high and supply is low. Currently, the industry employs 23,000 scientific personnel and the requirement is estimated to be 60,000 in 2009-10. Prominent indus try leaders and HR experts feel that it is difficult to find the right candidates as the skill sets of manpower produced by academic institutions often do not match the requirements of the ever competitive biotechnology industry. Finding the right people for the job is the immediate challenge faced by the industry, as industry finds it difficult to invest in in-service training of hired candidates. Realizing the need of trained manpower in biotechnology, the Department of Biotechnology (DBT) conceived an integrated approach for human resource development comprising of postgraduate teaching programs, training of faculty and mid-career scientists in national and overseas laboratories for upgradation of skills, participation in seminars and symposia. Initially, postgraduate teaching programs were started in six universities in 1985-86 and keeping in mind, the demand for trained manpower in specific areas as well as regional aspirations, these programs have been expanded in over 61 universities in general, medical, agricultural, marine, veterinary, industrial, pharmaceutical biotechnology (Figure 1). On an average, about 800 students are passing out each year (Figure 2). The programs have been conceived as collaborative, inter-departmental and inter-institutional programs and started on the basis of core strength of faculty, existing infrastructural facilities, R&D grants on competitive funding basis, nearby institutions engaged in biotechnology R&D etc. The catalytic role played by these has inspired many other institutes to initiate such programs on their own. Liberal grants are provided for establishment of specialized laboratory infrastructure, equipment, recurring grants for consumables, studentship, books and journals, travel, visiting faculty and contingency. These programs have not only improved quality of teaching and research in biotechnology but also the allied life science fields. In order to maintain uniformity and minimum standards of education, model course curricula have been developed and adopted by all with minor institutional variations based on in-house faculty strength. The curricula revision exercise is undertaken periodically to incorporate the latest developments. Faculty upgradation programs with emphasis on practical training have been initiated for faculty involved in undergraduate and postgraduate teaching to keep pace with the rapid advances in the area. Selection of students is made on all India basis through Common Entrance Test (CET) conducted by Jawaharlal Nehru University (JNU) for 42 universities, joint entrance test conducted by IIT or tests conducted by respective universities. The students coming out of these programs qualify in UGC-CSIR National Entrance Test (NET) for Junior Research Fellowship (JRF), DBT Biotechnology eligibility test (BET) for JRF and are pursuing research in leading laboratories in the country e.g. TIFR, BARC, IISc, NII, CCMB and JNU. A number of students find placement in leading industries such as Biocon, Dr Reddy's Laboratories, Shantha Biotech, Panacea, Advanced Enzyme Technology, Bharat Serum, Intas Pharmaceuti cals, Serum Institute, US Vitamins, Wockhardt, Zydus Cadila Pharmaceuticals. Employability of M.Tech students in industry is much better as compared to MSc General Biotechnology students, which is evident from Fig. 3 and 4. Considering the estimated growth in different sectors of biotechnology and taking stock of existing teaching programs, the Department has decided to initiate new programs in food and nutrition, clinical pharmacology and product development, bio-instruments and biomedical standards, bioenterprise management and financing and regulatory affairs. Taking note of industry requirements for candidates with practical skills, the Department started a program way back in 1992 for providing industrial exposure to biotechnology postgraduates for a period of six months in industry. It is intended to bridge the gap between the skill sets of students produced by universities and requirements of industry. This program is mutually beneficial as industrial exposure orients students to needs of industry increasing their acceptability for placement and an opportunity to the companies to assess the performance of trainees. Selection is very stringent and only 20 percent of eligible applicants are finally offered training. This training has become increasingly popular among students and industries as is evident from increase in the number of applicants, selected candidates and industries offering this training (Fig. 5, 6 and 7). During the last three years, 422 students have availed this training and as expected, MSc General Biotechnology students are the major beneficiaries of this program. During 2006-07, students have been offered training in R&D, production, marketing and analytical activities, quality assurance and control, regulatory affairs. Specific training has been offered in areas like animal health, transgenic plants, molecular marker assisted breeding, ecofriendly technologies such as biofertilizers, biopesticides, biofuels, micropropagation , vaccines and diagnostics, bioinformatics, purification and synthesis of industrial enzymes and proteins, clinical trials, awareness programs about deadly diseases such as AIDS. Approximately, 25 percent trained students find permanent placement in industry. Some of the industries which have absorbed trainees are Biocon, Dr Reddy's Laboratories, Shantha Biotech, Panacea, Advanced Enzyme Technology, Bharat Serum, Intas Pharmaceuticals, Serum Institute, US Vitamins, Wockhardt, Zydus Cadila Pharmaceuticals, Lifecare Innovations, Unique Biotech, Century Seeds, Sangene Biotech, Shanta Biotechnics, Dabur, Jubilant Biosys, Gangagen Biotechnologies, Monsanto, Avesthagen, Invitrogen, Ranbaxy, Bangalore Genei, United Breweries and Tata Tea. This training helps in refining the academic knowledge base of students by complementing with practical skills. It also reduces cost for in-service training and saves time resulting in enhanced quality and productivity. Going by the current and predicted growth rate of biotech industry in various sectors and corresponding e nhanced need for trained manpower, the DBT is considering to substantially increase the number of students to be trained every year in this program.   A list of leading biotechnology companies state-wise where the students have availed training in 2006-07: Karnataka (24): Bangalore - Avtar Diagnostics, Best Biotek Research Labs, Bhat Biotech, Biovet, Connexios Life Science, EID Parry (India), Gangagen Biotechnologies, Indo American Hybrid Seeds, Jubilant Biosys, Keragen Technologies, Metahelix Life Sciences, Monsanto Research Center, Multiplex Biotech, MWG Biotech, Natural Remedies, Rishi Herbal Technologies, Sigma Aldrich Chemicals, Sri Raghavendra Biotechnologies, Vittal Mallaya Scientific Research Foundation, Xpression Biotek, Indfrag, VB Medicare, Labland Biotech (Mysore), Labland Neobiotics. Andhra Pradesh (16): Hyderabad - AG Bioteck Laboratories (India), Bharat Biotech International, Biological E, Bioseed Research, Dr Reddy's Laboratories, Excel Matrix Biological, JK Agri Genetics, KN Biosciences, Shantha Biotechnics, Sreeven Pharma, Sri Biotech, Vimta Labs, Virchow Biotech, Zenotech Laboratories, Prathista Industries, Hi-Tech Pharmaceuticals. Maharashtra (10): Pune - Ajay Bio-Tech (India), Gennova Biopharmaceuticals, Indo Bioactive Labs, Jalna -Bejo Sheetal Seeds, Maharashtra Hybrid Seeds Co., Mumbai - Nicholas Piramal India Ltd, Roche Diagnostics, SRL Ranbaxy, Aurangabad - Nath BioGene, Nagpur - Maharashtra State Seeds Corporation. Delhi (7): Auroprobe Laboratories, J Mitra Co., LakshmiKumaran & Sridharan, NACO- National AIDS Control, Panacea Biotech, TechnoConcept (India), The Energy and Resources Institute. Tamil Nadu (5): Chennai - ABL Biotechnologies, Kevincare, Malladi Drugs & Pharmaceuticals, Orchid Chemicals & Pharmaceuticals, Shasun Chemicals and Drugs. Orissa (4): Bhubaneswar - Imgenex India, Kalinga Plant Resource Centre, Tectona Biotech Resource Centre, Utkal Biotech. Haryana (3): Gurgaon - Lifecare Innovations, Ranbaxy Research Laboratories, Thar Biotech. Uttar Pradesh (3): Ghaziabad - Biomed, Dabur Research Foundation, Noida - Jubilant Clinsys. Gujarat (2): Ahmedabad - Intas Biopharmaceuticals, Surat - Span Diagnostics. West Bengal (2): Siliguri - Peak Chemical Industries, Kolkata -East India Pharmaceutical Works. Pondicherry (1): Romvijay Biotech ]]> <![CDATA["Indian professionals will match or exceed abilities of US professionals"]]> https://biospectrumindia.com/news/95/7610/indian-professionals-will-match-or-exceed-abilities-of-us-professionals.html https://biospectrumindia.com/news/95/7610/indian-professionals-will-match-or-exceed-abilities-of-us-professionals.html Mon, 06 Aug 2007 14:40:00 +0530 New Page 1 "Indian professionals will match or exceed abilities of US professionals" Dr Kailash Joshi, former IBM executive and co-founder of The Indus Entrepreneurs (TiE), heads the core management team of the Global Institute of Intellectual Property (GIIP), New Delhi, as its chairman and mentor. In an interview with BioSpectrum, Dr Joshi throws light on the institute's approach to produce quality IP professionals. Excerpts: GIIP has been set up to cater to the growing global patent and IP services business? What is the present estimated size globally and what is the expected growth? How much of this market share do you think India can capture? The global data today adds up to a few million patents filed world-wide each year. In addition, there is the task of patent maintenance, management, litigation etc. that requires highly skilled technical and legal minds and entails several tens of billion dollars of business. Even if India captures 10 percent of this market, it will amount to several thousand high quality jobs and many multiple of secondary jobs. The revenues from patents royalties and licensing will become a measurable part of India's GDP as well. How is the industry in the US as compared to India where it is still nascent? The IP industry in the US is decidedly the most mature and extensive in the world. On a scale of 1 to 10, if the US is 8, then I would place India at around 2, but going up fast. How would you compare students taking up a career in IP and patents in India with those in the US? Where will India now take off with the course being offered by GIIP? I think there is a gap which we are trying to fill. In the US, the law schools teach some IP and then both law and technical graduates informally do on the job training. Since we have a chance to do it more comprehensively in India, we are pulling together both the academic and practical aspects of the IP knowledge in a formal diploma curriculum. We believe this approach will produce high quality professionals with serious knowledge of both the Indian and US systems. We do expect that the Indian professionals will match or exceed the abilities of the US professionals in this area. What do you think are the reasons why work in this field would be outsourced to India? Just like in IT and other KPOs, India has two advantages that will remain for quite some time. These are availability of skilled English speaking manpower and their competitive cost. Will the introduction of such a course change the view on patents and IP and more people take it as a career? Yes, IP and its economic impacts can be very significant. As India becomes more sophisticated, it will create huge IP of its own and also protect the IP of other nations. Both these will bear fruits in terms of prosperity in India and around the globe. What about plans to set up overseas centers of GIIP? First and foremost, we want to make the Delhi center very successful in terms of quality of training and students. Then we will expand to other Indian cities, other Asian countries where English is a language of IP (South Asia, Malaysia, Singapore etc) and then possibly to Europe and the US. Are you looking forward to any exchange programs with foreign universities? Yes, we are in discussions with a few US universities and will soon offer joint certification programs in India and also get some of our course participants to visit and work with the faculty and experts available at these universities. Do you plan to have any partnerships and collaborations besides the current exclusive partnership with Silicon Valley Seminars (SVS), USA? In the US, we are keen to associate with one or two leading universities for joint programs. In India, we have done a co-operative 6-week course with IIT Delhi recently. We would like to repeat it and also do similar programs with other educational institutions of repute. We are also actively building strong relationships with KPOs, law firms, as well as MNCs who will all benefit from our training programs and our IP expertise. Shalini Gupta   ]]> <![CDATA["We were in the process of setting up a legal process outsourcing institute"]]> https://biospectrumindia.com/news/95/7490/we-were-in-the-process-of-setting-up-a-legal-process-outsourcing-institute.html https://biospectrumindia.com/news/95/7490/we-were-in-the-process-of-setting-up-a-legal-process-outsourcing-institute.html Mon, 06 Aug 2007 12:42:00 +0530 New Page 1 "We were in the process of setting up a legal process outsourcing institute" Atulya Nath (AN) Girija Verma (GV) In an interview with Shalini Gupta of BioSpectrum, Atulya Nath (AN), CEO of GIIP, New Delhi, and Girija Verma (GV), senior advisor and curriculum co-chair, elaborate on what this new one-of-its kind institute has to offer to prospective students. Excerpts: How did you zero upon on the idea of coming up with such an institute with a novel concept? AN: We were in the process of setting up a legal process outsourcing institute and the focus was on intellectual property. We realized that there was a huge dearth of professionals in this area. Availability of good people trained on the US patents was almost negligible. We did a lot of research, talked to a lot of professionals, studied what was happening in the US and the kind of people getting into it as professionals. We realized that we could devise such a program that will be a jigsaw between theory and practical. It would be delivered on a full time basis because people who are looking to build careers in this will have to put in lot of efforts. GV: There are two more reasons why we came up with this program. First, there have been changes in the Indian legislation. The patent law has changed and I think that is going to show a lot of activity in the area of transaction in patents. India will see not only the filing of patents but also a lot of litigation. Also, a lot of Indian companies are going internationally. We have a far developed pharmaceutical industry and so far it is dependent on the generic market, but as it continues to expand, we are going to see a growth in the market. So, it is a growing market both ways: not only outsourcing of patents to India, but also Indian companies going international. What kind of students are you expecting to train? GV: Mainly we are trying to get people from a technical background for our full time 9-month diploma course, i.e people from science and technical backgrounds, MTech and PhDs, lawyers with relevant experience and BTech with good amount of experience. Fresh graduates can also be taken but they shall have to go through our selection process. Only those with a keen interest on the subject shall be taken. The soon to be started corporate program would be for working professionals who are doing research in corporates and require industry specific knowledge to move up the value chain. What career opportunities can one look forward to? AN: The career opportunities range from patent drafting to patent valuation, licensing and litigation support services. Job opportunities will be global, they would not be restricted to people working in the Indian patent law. They can be employed by anyone who is working in the international framework. One can work in Knowledge Process Outsourcing (KPO) firms, Legal Process Outsourcing (LPO) firms, IP departments of Indian corporations, MNCs, government and R&D institutions, or law firms. How are you looking at placing students after completion of the course? AN: We have been in talks with corporates, certain legal process outsourcing companies and in fact some have also issued us a letter of interest saying that they would come to our campus for recruitment. They have gone through our course syllabus and we have been having interactions with them wherein they are impressed and have been asking us for corporate training programs which we are holding off till September. IP and patent industry Program offered Initially GIIP will offer Post graduate Diploma in International Patents & Intellectual Property Services, a 9-month full time program, across three semesters. The curriculum comprises up-to-date education in the US and Indian patent laws and IP practices and has been designed by patent agents/professionals from the US and India. These include conducting international patent searches, drafting patent claims and patent applications. Course methodology The 9-month training program includes six months of practical training with international trainers and experts mentoring individual students in the last 3 months. The whole 600 hours of this program will include 60 percent of it delivered by the trainers trained under practitioners in the US and 40 percent by them directly. It includes: Classroom lectures delivered through video conferencing by experienced instructors and IP practitioners Online e-learning modules Mentoring sessions: Individual guidance from IP practitioners and experts, specific to the technical field of the participant Illustrations and case study methods Interactive sessions with both instructors and peer group Faculty A core team with considerable teaching experience trained by the core group in the US. Also academicians from reputed institutions like IIT, IIM, Law Schools, R&D labs, PFC (TIFAC), etc. Professionals from the World Intellectual Property Organization (WIPO), International Organizations, Government institutions and KPO & LPO firms involved in IP offerings.   Is the course recognized by any government institution? AN: We are looking at an association with government agencies but nothing in terms of an approval is there as far as AICTE is concerned. Are you looking forward to any exchange programs as well? AN: We are talks with some of the universities in the US and we are looking at joint certification programs with them. Students could go there and get some exposure. We are working towards it. What are your future plans? AN: In the second year, we are planning to bring a portion of this course online. We are also planning to have centers in different cities in India. There will be local trainers to deliver the course. The entire course cannot be online. Contact classes will be required. We are also planning a lecture series every two months where there will be one international speaker on a specific subject. We are also planning paid workshops every quarter wherein corporates will be invited and carry them to multiple cities. We have been receiving invites from institutes for whom we would like to devise programs. In short, we want to create awareness in this field so that we can commercialize our research and have more professionals in this field.   ]]> <![CDATA[GIIP announces post graduate diploma program in patents and IP services]]> https://biospectrumindia.com/news/95/1895/giip-announces-post-graduate-diploma-program-in-patents-and-ip-services.html https://biospectrumindia.com/news/95/1895/giip-announces-post-graduate-diploma-program-in-patents-and-ip-services.html Mon, 06 Aug 2007 12:34:00 +0530 New Page 1 GIIP announces post graduate diploma program in patents and IP services Global Institute of Intellectual Property (GIIP), co-headquartered in New Delhi and San Jose, USA, announced the launch of Post Graduate Diploma Program in Patents and Intellectual Property (IP) services. GIIP's full-time nine-month (tri-semester) post graduate diploma program will commence from August 2007 and is designed for graduates and post-graduates in engineering, biotech, pharma and other technical fields. The GIIP program is claimed to be the first of its kind in the world to train professionals for the rapidly growing global patent and IP services business. GIIP, in collaboration with Indian Institute of Technology (IIT) Delhi, also completed a six-week certificate course on patents and IP services successfully. "We believe that GIIP will prepare the students for attractive career opportunities in patent drafting, prosecution and IP, as some of the best IP practitioners and experts trained in the US will be conducting the courses" said senior advisor to GIIP, Dr VS Ramamurthy, former secretary of the Department of Science and Technology, India. The GIIP team consists of successful IP practitioners, entrepreneurs, US attorneys, and technical trainers who are guided by senior experts. Chairman and mentor of GIIP, Dr Kailash Joshi, former IBM executive and co-founder of The Indus Entrepreneurs (www.tie.org) said, "We are pleased that we have architected a very strong training program for India that will be conducted by distinguished IP professionals and trainers. Our vision is to expand the program to several cities in India and other countries, including the US."   ]]> <![CDATA[Jubilant Organosys Q1 net up three-fold]]> https://biospectrumindia.com/news/95/5621/jubilant-organosys-q1-net-up-three-fold.html https://biospectrumindia.com/news/95/5621/jubilant-organosys-q1-net-up-three-fold.html Mon, 06 Aug 2007 12:27:00 +0530 New Page 1 Jubilant Organosys Q1 net up three-fold Jubilant Organosys has announced its financial results for Q1 FY2008. The company reported a three-fold jump in its net profit for the first quarter ended June 30, 2007 at Rs 142.9 crore as against Rs 46.1 crore in the corresponding quarter previous fiscal. The company's net sales during the quarter grew 31.3 per cent to Rs 540 crore from Rs 411.2 crore in the same quarter a year ago. Commenting on the company's performance, Shyam S Bhartia, CMD and Hari S Bhartia, co-chairman and MD, Jubilant Organosys, said: "Jubilant's strategy of going to market as a full-suite, integrated, outsourcing partner is paying richly at a time when global pharma is increasingly looking eastward to meet production and research needs. At our end we leverage resources in a bid to realize the gains from outsourcing opportunities. Our objective remains to steer the company into progressively better margin trajectories, evaluating continuously options for realizing organic and inorganic growth within the pharma and life sciences landscape and particularly in CRAMS and drug discovery and development services space. We have seen direct increments to revenues and earnings on account of Hollister-Stier acquisition during the quarter and also recorded incremental benefits from the operational improvements across the other segments. In our industrial and performance products businesses, we are witnessing resurgence in earnings due to overall improvements in its operations" Jubilant's overseas business grew 57.9 per cent in the quarter to Rs 278.9 crore compared to Rs 176.6 crore in the same quarter last year. Exports contributed 51.6 per cent to the company's overall revenues.   Ranbaxy Q2 global sales up by 25 percent Ranbaxy Laboratories has announced consolidated global results for the quarter (Q2) and half year (H1) ended June 30, 2007. For Q2, Ranbaxy has achieved sales of $395 million, recording a growth of 12 percent. Profit before finance cost, depreciation, tax and amortization was $55 million, reflecting an EBITDA margin of 14 percent to sales. Profit after tax was at $65 million, recording an increase of 118 percent. For H1, the company recorded sales of $750 million, registering a growth of 17 percent. Profit before finance cost, depreciation, tax and amortization was $98 million, reflecting an EBITDA margin of 13 percent to sales. Profit before tax stood at $120 million, an increase of 109 percent. Commenting on the financial results, Malvinder Mohan Singh, CEO and MD, Ranbaxy, said, "The results reaffirm our faith in our underlying strategy and gives us the confidence that the ensuing quarters will be progressively better." For Q2, global sales registered an increase of 25 percent to $395 million. India, Russia, Ukraine, Romania and South Africa continued to be the primary drivers of performance in the emerging markets, while Europe contributed significantly to the growth in the developed markets. For H1, global sales were at $750 million, recording a growth of 24 percent. The US clocked sales of $95 million, a growth of 7 percent for the quarter. For H1 sales stood at $180 million, a marginal increase of 2 percent. Excluding the impact of the products launched with a 180 days marketing exclusivity in the current and corresponding previous period, the sales in the US grew 37 percent, reflecting the encouraging performance in the company's base business portfolio.   Nicholas Piramal reports Q1 FY2008 results Nicholas Piramal India Ltd (NPIL) reported the first quarter (Q1) results for FY2008. Consolidated revenues for the quarter ended 30 June 2007 increased by 16.4 percent to Rs 610 crore over the first quarter of FY2007. Operating profit was lower by 4.2 percent to Rs 84 crore. On the domestic market front, NPIL's branded formulations sales grew by 0.5 percent during the quarter to Rs 290 crore. This was primarily because of lower sales of Codeine-based formulations. Codeine is a raw material controlled by the Government of India. The Government is taking steps to improve availability of this raw material. NPIL's international sales were up by 36.8 percent to Rs 240 crore. Sales from contract from India assets were Rs 27.4 crore as compared to Rs 20.38 crore for Q1FY07. The sales from Pathlabs increased 79.5 percent to Rs 25.19 crore. On the R&D front, NPIL has recently announced that its IND application for P276-00 has been approved by USFDA. P276-00 is NPIL's lead cancer compound, which is currently undergoing Phase I clinical trials in India and Canada. With this approval, NPIL will commence Phase I clinical trials in USA for treatment of Multiple Myeloma.   Suven files NCE SUVN-502 IND application in India Suven Life Sciences has submitted its first application to the Drug Controller General of India. The company is seeking permission to undertake Phase I clinical trials of its Investigational New Drug (IND) SUVN-502. SUVN-502 is a novel, potent, safe, highly selective and orally active antagonist at a central nervous system serotonin receptor site 5-HT6, intended for the treatment of cognitive disorders such as Alzheimer's and schizophrenia. Suven is committed to neuroscience research and for development of new treatments for neurological disorders. Suven's discovery research focuses on Central Nervous System (CNS) disorders through novel mechanisms using small-molecule medicinal chemistry approaches. Suven's CNS drug discovery scientists at Hyderabad, India are pursuing innovative ways to develop treatments for a variety of CNS disorders like Alzheimer's, schizophrenia, depression, cognitive disorders and neurodegeneration.   Lupin's herbal psoriasis drug enters Phase III trials Lupin has received approval from the Drugs Controller General of India (DCGI) to conduct a combined Phase IIb/III clinical trials for its herbal anti-psoriasis compound LLL-3348 (Desoris). The botanical drug product LLL-3348 is a once-daily oral formulation for treatment of chronic stable plaque type psoriasis. The approval comes after the company successfully completed an initial Phase II clinical trial in which it evaluated the oral drug product in different lower doses. The study was a multicentric, placebo-controlled, randomized, double blind, parallel group study. Lupin chairman, Dr DB Gupta, said, "We are delighted with the approval and look forward to taking LLL-3348 through Phase III clinical trials now and bring it to the market. This is a very important product for a highly unmet need and we look forward to addressing it effectively and safely." The company intends to immediately begin a combined Phase IIb/ III clinical trial with higher doses in close to 10 centers across the nation. The total market for psoriasis is estimated to be more than $ 2 billion. The company also has three other New Chemical Entities (NCEs) in various stages of clinical trials.   AstraZeneca in siRNA partnership with Silence London-based Silence Therapeutics has entered into a R&D collaboration with AstraZeneca primarily in the respiratory field. Silence Therapeutics will receive initial access fees, clinical development and commercial milestone payments of up to $400 million plus royalties on product sales. The three-year collaboration is designed to discover and develop proprietary siRNA molecules against up to five specific targets provided by AstraZeneca. Silence Therapeutics and AstraZeneca will jointly collaborate in the early phase of identification and optimization of novel siRNA molecules. AstraZeneca will retain full responsibility for the clinical development and commercialization. The agreement is primarily in the respiratory field but includes an option to allow for targets that extend the collaboration into other disease areas of interest to AstraZeneca. Silence will provide AstraZeneca with a license to its proprietary siRNA technology in return for an initial access fee of $15 million, comprising a payment of $5 million, plus an equity investment of $10 million. As a result of this agreement, AstraZeneca will hold 2.94 percent of the total voting rights of Silence Therapeutics.   Granules in pact with Heritage Granules India has entered into an alliance with US-based Heritage Pharmaceuticals to develop, supply and market generic pharmaceutical products for the US prescription drug market. Granules will develop and register selected products for US ANDA submission and Heritage will retain exclusive sales and marketing rights to such products. Granules will receive up front and milestone payments and the parties will share net profits from the product sales. "This is in line with our overall strategy for partnering with prescription product marketers on a development and manufacturing agreement. We are confident that Heritage will deliver the required market share to make it a mutually profitable business model," said C. Krishna Prasad, managing director, Granules India. "Our partnership with Granules represents another important milestone in Heritage's business model of utilizing strategic outsourcing for the development and manufacturing of quality generic products. Granules PFI (Pharmaceutical Formulation Intermediates) technology represents a significant cost advantage for high load- high volume generic products and will provide us with unprecedented economies of scale for the products under our Agreement," said Jeffrey Glazer, President and CEO, Heritage Pharmaceuticals. Heritage owns 15 US ANDAs to be launched under the Heritage label over the next fiscal year.   Flamingo Pharma to manufacture Zolpidem for Teva Flamingo Pharmaceuticals Ltd announced that it has bagged the order from Teva Group to manufacture Zolpidem tartrate tablets for Netherlands market. Flamingo is currently working on 12 CRAMS projects for global pharma majors and would be starting operations on 10 new projects by end of 2007. Flamingo's CRAM business currently contributes about Rs 60 crore to its Rs 160 crore turnover. Zolpidem is the sixth product manufactured by the company for the Teva Group.   RSIL, Evotec announce formation of Evotec-RSIL Research Support International Limited (RSIL), a subsidiary of DIL, and Evotec AG have announced the formation of a joint venture in India, Evotec-RSIL, to design, synthesize and manage compound libraries as a service. The joint venture will combine Evotec's expertise in library design, synthesis, analysis, purification and project management with RSIL's first class scientists coupled with a low cost structure in India to provide a high quality, cost efficient solution for the provision and management of compound libraries to the pharmaceutical industry. The joint venture will be located in Thane, near Mumbai, and will use newly constructed, state-of-the-art laboratories. Evotec-RSIL Ltd will design compound libraries of low hundreds to thousands of compounds per scaffold by accessing chemistries already validated at Evotec and/or RSIL. As well as being able to design and synthesise compound libraries the joint venture will also offer library management services in which it will be able to analyze and purify large screening libraries in a cost efficient manner. "Evotec has enjoyed an enviable reputation in the synthesis of large screening and focused libraries for many years. Through this joint venture we are able to team up with the excellent scientists and management at RSIL to continue to provide this invaluable service at competitive prices for our customers. We are very pleased to collaborate with RSIL, one of India's premier chemistry services business", commented Dr Mario Polywka, COO of Evotec. "With the formation of this joint venture through a contribution in kind of Evotec's library business, Evotec is making another significant step in its strategy to focus its core business in Europe on high value solutions and products for the pharmaceutical industry."   Glenmark purchases rights to two therapeutic antibodies from Chromos Glenmark Pharmaceuticals SA, the wholly-owned Swiss subsidiary of Glenmark Pharmaceuticals Ltd, has announced that it has completed the purchase of two New Biological Entities (NBEs), CHR-1103 and CHR-1201, from Chromos Molecular Systems Inc. of British Columbia, Canada. The two NBE's are humanized monoclonal therapeutic antibodies. Under the terms of the transaction agreements, Glenmark has purchased all rights to the two products as well as rights to use Chromos' proprietary ACE System technology for cell line development for use with respect to CHR-1103 and CHR-1201. Glenmark holds the worldwide rights for further development, registration and commercialization of these products. CHR-1103 and CHR-1201 are part of a validated class of drugs known as SAMIs (selective adhesion molecule inhibitors) that includes drugs such as ReoPro (Centocor/Lilly), Raptiva (Genentech/Xoma) and Tysabri (Biogen/Elan). CHR-1103 is a broad anti inflammatory agent with a novel mechanism of action, being developed initially to treat acute multiple sclerosis, for which there is no treatment approved at present. Glenmark plans to initiate Phase I clinical trials in 2008 and complete Phase I on CHR-1103 by March 2009. CHR-1201 is an anti-thrombolytic humanized monoclonal antibody, which Glenmark plans to develop initially to treat acute stroke. Glenmark plans to start Phase I on CHR-1201 by March 2009. Glenn Saldanha, managing director and CEO, Glenmark Pharmaceuticals Ltd, said, "This is a very important addition to our pipeline of Novel Biological Entities. These two NBEs would help accelerate our pipeline in the biologics space." ]]> <![CDATA[Stem cell research still at modest levels]]> https://biospectrumindia.com/news/95/6349/stem-cell-research-still-at-modest-levels.html https://biospectrumindia.com/news/95/6349/stem-cell-research-still-at-modest-levels.html Mon, 06 Aug 2007 11:55:00 +0530 New Page 1 Stem cell research still at modest levels There is a lot of talk about stem cells in India, yet the research here is at modest levels. In May this year, Bangalore-based Manipal Hospital announced a major breakthrough in the treatment of Parkinson's disease using stem cell therapy. It presented the case of Andrew Kisana, a US national. The doctors at the hospital said that the patient's bone marrow was harvested at the regenerative medicine department and the mesenchymal stem cells were injected into the part of the brain, which was affected because of Parkinson's disease. Kisana had received three injections. This was the first time such a major effort was attempted in India for treatment of Parkinson's disease. Kisana was suffering from the degenerating disorder for 15 years. After undergoing intensive drug therapy, lesion and deep brain stimulation (DBS), he had come to Manipal Hospital. "The successful recovery of the patient would give hope to scores of Parkinson's cases which affects one percent of the population. The condition largely manifests in cases above 50 years, but there are younger people being affected. Stem cell therapy now gives such patients a new hope. However, we need to observe the long term clinical effects in larger number of patients to decide whether it is primary or secondary or supplementary treatment option for degenerative disorders," said Dr NK Venkataramana, director, Manipal Institute of Neurological Disorders. The hospital's regenerative medicine department is currently carrying out clinical trials in stem cell therapy in 15 spinal cord injury patients besides researching in the use of stem cells in patients of heart attack and leg ischemia, said Satish Totey, chief scientific officer of Stempeutics Research (the regenerative medicine research arm of the hospital). Ramesh, a patient with spinal cord injury, was treated with stem cell injection. "After the treatment I am able to pass urine and can move my hands. My sensations have also come back," he said. Stem cells provide deeper insights into embryonic development and can be magic bullets to cure such debilitating diseases such as Parkinson's and Alzheimer's or and they can aid pharma companies in early stage screening of drugs, thus cutting on costs and bringing life-saving drugs to the market faster. So the question is, where do we stand now on stem cell research? Specifically, what is the status of the ethics and policy debate? What can we hope to be accomplished on stem cell research and in regenerative medicine? What is the capacity for the researchers to make reproducible and meaningful clinical progress? And what is a sensible government policy that can take into account both the ethical considerations as well as the hopes for medical progress? The unanimous feeling is that India is well positioned to emerge as a significant player in the global stem cell research area. India is particularly interested in the clinical application of stem cells in ophthalmology, cardiology, diabetes, and spinal cord repair. There is also keen interest from big biotech companies in the US, Canada and the UK, in joint venture projects with Indian researchers. The Indian Council for Medical Research allows the use of fetal cells up to 14 weeks of pregnancy. The big question, however, is how will these cells be put to use a few years down the line, and how well will the stem cell banks that are coming up maintain them, in the absence of specific guidelines. The CCMB has a collaboration arrangement with the Deccan Medical College (DMC) for liver stem cell research. The DMC and the Japanese Nichi-in Centre for Regenerative Medicine, which has developed a gel that preserves stem cells, are ready to undertake human trials using stem cells in end-stage liver failure patients. The CCMB has also done work with the LV Prasad Eye Institute in growing corneal limbal cells, which help in repairing the damaged corneal tissue and restoring vision. Doctors have successfully performed more than 200 such procedures. CCMB is also working with Biological E on the use of cord blood cells and is venturing into newer areas. It has simultaneously built up facilities that can aid industry and other research institutes. For example, its Nuclear Magnetic Resonance (NMR) imaging facility being set up with the help of the Department of Science and Technology (DST), would allow imaging of cells and enable an insight into the effects of drug molecules at the cellular level. This would obviate the need to sacrifice animals for scientific experiments. It has also developed transgenic gene models of mice, for conducting drug trials. Overall, research efforts by the scientific community or industry are still at modest levels, though a few major groups are working in specific areas. The LV Prasad Eye Institute, Hyderabad has been putting research in adult stem cells to good use. Here doctors take about one millimetre limbal tissue from the healthy eye of the patient, culture them on an appropriate surface and graft it on the diseased eye. Such limbal stem cell treatment is available in only two other countries- the US and Taiwan. AIIMS has claimed reasonable progress in therapeutic stem cell research work. Using bone marrow mononuclear cells, it has initiated clinical trials on about 40 patients. The focus is on treating muscular dystrophy, spinal cord injury, cerebral dysplasia, heart tissue damage, diabetes and motor neuron disease. AIIMS has marked a global first in pioneering stem cell medicine by the "injection method", for reviving heart muscles, placing the institute right at the top of the world's medicine map. LifeCell, a stem cell banking and research company in India, has enrolled 3,000 expectant women for stem cell banking in just 20 months of operations, thereby creating a landmark in the stem cell industry. LifeCell has 18 stem cell collection centers across the country, which have collected 3,600 samples so far. And it plans to increase the number to 31 by March 2009. Mumbai-based Reliance Life Sciences and Bangalore-based National Centre for Biological Sciences (NCBS) for being among the ten elite research institutions in the world invited by America's National Institute of Health (NIH) to take part in the federally funded research on embryonic stem cells. While the Reliance Life Sciences has isolated stem cells which are in various stages of development, the NCBS was in possession of potential stem cell lines which are yet to be characterized. At NCBS, Dr Mitradas Panicker is working on embryonic stem cells and neurostem cells forming neurons. On the other hand, Reliance Life Sciences is committed to spending another $200 million over the next five years to reap the benefits of stem cell research. Reliance Life Sciences has characterized 10 stem cell lines including two neural SC lines, dopamine producing neurons and neurons for stroke patients. Dr Balkrishna Matapurkar, a surgeon at New Delhi's Maulana Azad Medical College, has pioneered a stem cell based technique for the regeneration of tissues and organs. He already holds a patent for this innovative technique. "Although India is ahead of most countries in stem cell research, the work here is still in its infancy. Indian players are building expertise in the field of stem cell research and at the same time the DBT is playing a significant role in encouraging the researchers and is trying hard to fund people in the field" said Dr Mitradas Panicker. Indian scientists worked on stem cells successfully, using corneal stem cells to treat retinal damage and goat stem cells to address liver ailments, studying stem cells from mouse embryos and using umbilical cord blood stem cells to treat genetic blood disorders. So far, government spending on stem cell research has been limited; about $200,000 was budgeted for such programs last year. Futuristic experiments, officials said, are a low priority in a country in which millions of people have no access to basic health care. Even as scientists and laypersons alike remain divided on the hype, hope and ethical issues surrounding stem cells and cloning, countries have evolved their own policies, ranging from permissive to restrictive. For example, the US and Germany have restrictive policies on stem cell research and funding owing to ethical issues. In contrast, the UK, Singapore, Japan, South Korea, Belgium and Israel are more liberal. Taking the middle ground are countries such as Australia, Canada and Spain. To protect its own interests, India needs to urgently put in place a carefully-thought-out policy in this area. Jahanara Parveen       "India should encourage adult stem cell usage for various life threatening diseases" -Dr Ramananda S Nadig, former COO, Stempeutics Research What are the bottlenecks in commercialization of stem cells? As of now the bottleneck for commercialization of stem cells in this country is the lack of clear guidelines either from the DCGI or the ICMR. While everyone is going gaga about stem cells, there is no clear appreciation of stem cells as a new biological entity, clarity on pre-clinical animal testing requirement, need for a phase I study in humans and a blue print on how to get them to the market. Adult stem cells are being used in bone marrow transplants without a clear OKAY for various indications. What are the latest developments in stem cell research? The latest developments in stem cell research is the fact that the US FDA has accorded a fast track approval for Osiris, a US-based company, to conduct a phase III study of the use of mesenchymal stem cells in graft versus host disease. Based on the results of this study, there is every likelihood that Osiris would be permitted to market these MSCs. The fact that the US FDA has accorded this status to MSCs is significant and will probably pave the way for many other drug authorities to consider permitting such trials. What according to you is the most significant breakthrough in stem cell research and application? The most significant breakthrough in stem cell research as of now is the fact that we have understood the phenomenal potential of adult mesenchymal stem cell use in various indications. The initial response is very encouraging and the subjective improvements seen in our patients will have to stand the scientific scrutiny of well planned proof of concept studies before stem cells are accepted by physicians practicing evidence based medicine. What's your view on the stem cell research legislation in India? We in India seem to be waiting for either for the US FDA or the European authorities to lead and formulate stem cell guidelines before we have our own plans. While the recommendatory efforts of the ICMR and DBT are laudable, we still do not have concrete guidelines on clinical trials with these new biological entities. The time is ripe for us to get our act together and have an interim plan that will permit organizations like Stempeutics go ahead with the Phase II proof of concept studies, analyze the results and strategize our regulations. I strongly feel that we in India should encourage adult stem cell usage for various life threatening diseases for which we have as of now no clear cure and regenerate hope amongst those suffering. Hasthana Rajappa   Stem cell policy, guidelines being discussed India is rapidly emerging as a hub for stem cell research with the market for stem cell research in India estimated to be about $540 million by 2010. However, we are yet to have a policy on the same lines, but it may soon become a reality. Draft guidelines for stem cell research were formulated jointly in 2006 by the Indian Council for Medical Research (ICMR) and the department of biotechnology (DBT) under the ministry of science, New Delhi. These guidelines address both ethical and scientific concerns such as destruction of human embryos to create human embryonic stem (hES) cell lines, potential for introducing commodification in human tissues and organs and possible use of technology for germline engineering and reproductive cloning.   Principles The guidelines state that any research on human beings, including human embryos, as subjects of medical or scientific research or experimentation, should adhere to the general principles outlined in the "Ethical guidelines for Biomedical research on Human Participants issued by the ICMR in 2006. The principles include essentiality of research with potential health benefits, respect for human dignity and rights, individual autonomy with respect to informed consent and privacy of the individual concerned. It also takes into account beneficence with regard to improvement of health of individuals and non-maleficience with the aim of minimization of risk and maximization of benefit.   Monitoring mechanism All institutions and investigators carrying out research on human stem cells should be registered with the National Apex Committee for Stem Cell Research and Therapy (NAC-SCRT) through Institutional Committee for Stem Cell Research and Therapy (IC-SCRT). All clinical trials with any stem cell will also need to have prior approval of IC-SCRT and the Drug Controller General of India (DCGI) for marketable product and shall be registered with NAC-SCRT. Any International collaboration shall also have prior approval of NAC-SCRT or a respective funding agency as per its procedure or the health ministry's screening committee.   Categorization of stem cell research The research on human stem cells is categorized in three areas depending on the source of stem cells and the nature of experiments. Permissible: It includes in vitro studies on established cell lines from any type of stem cell and in vivo studies with established cell lines from any type of stem cell. In vivo studies can be carried out on experimental animals (other than primates) using fetal/adult somatic stem cells from bone marrow etc provided appropriate consent of the donor is obtained. Establishment of new human embryonic stem (hESC) from spare supernumerary embryos is also allowed with appropriate consent from the donor. All the above studies need the prior approval of IC-SCRT. Once a cell line is established it needs to be registered with the IC-SCRT and NAC-SCRT. Restricted: This includes the creation of a human zygote by IVF, CNT or any other method with the aim of deriving a hESC line. A specific justification stating that the creation of the zygote is critical and essential for the research would be required and only then would it be approved by the NAC-SCRT through IC-SCRT. It also includes clinical trials sponsored by MNCs involving stem cell products imported from abroad, studies on chimeras where stem cells from two or more species are mixed and introduced into animals including primates at any stage of development. Further research involving introduction of human embryo stem/germ/somatic cells into animals at embryonic or fetal stage of development for studies on pattern of differentiation and integration of human cells into non-human animal tissues is also restricted. Only when there is a strong scientific justification would such a research be approved. Prohibited: It includes transfer of blastocysts/human embryos generated by SCNT/parthenogenetic to a human or non-human uterus; research involving the directed non-autologous donation of stem cell lines to an individual; research in which any cells of a pluripotent nature are combined/grafted with a human or non human embryo/ foetus. Also embryonic stem cell research involving in vitro culture of any intact human embryo for longer than 14 days is not permitted nor is research involving introduction of embryonic cell into human or non-human primate blastocyst.   Cord blood stem cell banking The guidelines allow for clinical use of cord blood stem cells. All cord blood banks have to be registered with the DGCI as per the guidelines of the blood banks. Purpose of banking should be explained to couples interested in storing cord blood. For this, standard operative procedures for collection, transportation, processing, storage, preservation and clinical use of umbilical cord blood should be laid down with approval of the IC-SCRT along with a detailed protocol of isolation and characterization of stem cells. Several other points need to be taken into consideration as per the ethical guidelines of ICMR.   Approval for derivation of a new hESC line When approving proposals for derivation of a new hESC line whether from spare embryos or embryos created for the purpose, only those proposals shall be approved that show that they would help develop methods to detect abnormalities in embryos before implantation, will increase knowledge about serious diseases, develop methods of therapy for diseased or damaged tissues or organs. The research teams for the same should have appropriate expertise and training in derivation, characterization and culture of ES cells.   Procurement of gametes, blastocysts or somatic cells The IC-SCRT should review the process of procurement of gametes, blastocysts or somatic cells for the purpose of generating new hES cell lines. In this respect, consent for donation of supernumerary embryos should be obtained from each donor at least 24 hours in advance. Blastocysts made through IVF specially for research purposes and gametes and somatic cells donated for development of hESC lines derived through SCNT or by parthenogenesis or androgenesis should also have approval of IC-SCRT.   Banking and distribution of hES cell lines The draft guidelines adhere to key ethical principles that focus on the need for consent of donors and a system for monitoring adherence to ethical, legal and scientific requirements. It is necessary to ensure that the hESC were obtained ethically and with informed consent of donors, were well characterized and screened for safety and the conditions under which they were stored meet the current standards of good lab practices (GLP), good manufacturing practice (GMP) and good tissue practice (GTP). Also institutions planning to bank hESCs should establish uniform guidelines to ensure that donors of material give informed consent through a process approved by the IC-SCRT.   Use of stem cells for therapeutic purposes There is no approved indication for stem cell therapy as a part of routine medical practice, other than Bone Marrow transplantation (BMT). Hence all stem cell therapy other than BMT shall be treated as experimental. It should be conducted only as clinical trial after approval of the IC-SCRT/IEC and DGCI (marketable products). All experimental trials shall be registered with NAC-SCRT. Also the centers carrying out stem cell clinical trials and the agency/source providing such cells for the trial should be registered with NAC-SCRT through IC-SCRT/IEC.   Draft guidelines Draft guidelines were discussed on November 7, 2006, jointly by both the committees of the DBT and ICMR in a meeting organized by the DBT, when it was decided that there should be an Annexure on "Laboratory standards for cell collection and processing for research and therapy. The DBT then organized a meeting of the joint committee of ICMR and DBT on July 16, 2007 at Bangalore to discuss the Annexure on "Laboratory standards for cell collection and processing for clinical use." The document is being circulated amongst the members of the joint committee and based on the comments received by the members, it will be finalized. The draft guidelines will then be hosted on the ICMR/DBT website inviting comments from the general public. Shalini Gupta   ]]> <![CDATA['We help businesses into Australia']]> https://biospectrumindia.com/news/95/6588/we-help-businesses-into-australia.html https://biospectrumindia.com/news/95/6588/we-help-businesses-into-australia.html Mon, 06 Aug 2007 11:45:00 +0530 New Page 1 'We help businesses into Australia' - Kerry Rooney General Manager-Technology and Manufacturing Industries, Invest Australia Australia is aggressively attracting investments. Invest Australia, the country's official agency for inward investment promotion, helps global companies establish their businesses in Australia. In an interview with BioSpectrum, Kerry Rooney, General Manager of Technology and Manufacturing Industries, Invest Australia, elaborates on how the agency mediates foreign investment in the life science sector. Rooney and her team were in Hyderabad, earlier this year, for exploring collaboration opportunities in the sectors of biotechnology, pharmaceuticals, advanced manufacturing and nanotechnology. What is Invest Australia's role in the life science sector? Invest Australia is the government agency responsible for attracting investments in Australia. We play the role of a facilitator by bringing companies working on the similar expertise together. It is Invest Australia's duty to identify companies nationally and internationally that work in similar functional areas. Once we identify such companies, we bring them together for an effective partnership. Foreign companies can then leverage on Australia's expertise. Invest Australia is geared towards lifting Australia's profile as an investment destination. Why is Australia looking out for partners and collaborators in the life sciences arena? Australia has a very strong life science research base. The country contributes to about 2.5 percent of the world's research in the medical field. A number of such researches have resulted in key product development. However, I must admit that in Australia we hardly witness king-size capital investments. Australian firms lack financial depth and appropriate market expertise to take a product from innovation to the market. We need to partner to get the necessary capital so that we can take products from laboratory to market faster. Many early stage discoveries are not exploited because of lack of funds. Invest Australia's goal is to improve commercialization and ensure returns on funding in R&D. Is this why CSL collaborated with Merck? Yes. In 1995, Merck entered into a license agreement and collaboration with CSL for the technology used in Gardasil, the cervical cancer vaccine. The vaccine came into the market after 10 years of research by Dr Ian Frazer and his team at the University of Queensland. The technology was first licensed to Australia-based biomedical company CSL. The size of the capital investment required to take Gardasil to the market was very large. Even a big company like CSL had to collaborate with Merck to bring the vaccine to market. The launch of the vaccine in global markets would not have been possible without this alliance. What are Australia's strengths in the areas of biotechnology, pharmaceuticals and medical technology? Australia has developed world-class strengths in life sciences. Innovative R&D has paved way for major breakthroughs. Apart from the discovery of the cancer vaccine Gardasil, the country is associated with the discovery of antibiotic penicillin, Relenza for flu, Aridol for asthma, cochlear implant, bionic ear and omega 3 fatty acids. Moreover, Australians are proud to be associated with a Nobel Prize-winning discovery of bacteria called Helicobacter pyroli that causes stomach ulcers. In addition, Sydney- based company, ResMed, has designed an innovative lightweight palm-sized sleep apnea treatment device to alleviate common breathing and snoring problems. Our researchers have abundant expertise in oncology, cardiovascular diseases, metabolic diseases and vaccine technology. Hasthana Rajappa   ]]> <![CDATA['JE, EV71 vaccine in clinic by 2008']]> https://biospectrumindia.com/news/95/1428/je-ev71-vaccine-in-clinic-by-2008.html https://biospectrumindia.com/news/95/1428/je-ev71-vaccine-in-clinic-by-2008.html Mon, 06 Aug 2007 11:39:00 +0530 New Page 1 'JE, EV71 vaccine in clinic by 2008' - Douglas Thomson, CEO, SingVax Singapore's first vaccine development company, SingVax, focuses on developing prophylactic vaccines for infectious diseases of relevance to the Asia Pacific region and aims to be the partner of choice for vaccine companies seeking to access the Asia Pacific vaccine market. Led by its CEO, Douglas Thomson, SingVax has two products under development â€“ a Japanese Encephalitis (JE) vaccine and an Enterovirus 71 (EV71) vaccine. The company has adopted a product-focused approach and is looking out for partners to help commercialize the products. In an interview with BioSpectrum, Thomson outlines how far SingVax has come since its launch in 2005 and the road ahead. What prompted you to set up SingVax? SingVax's other founder, Joseph Santangelo and myself saw the market need for vaccines for infectious diseases prevalent in the Asia Pacific region, and this was the main driver for setting up SingVax. How far has SingVax come since its launch in 2005? SingVax has made significant accomplishments since its launch. These include: Establishing of world-class biologics development capabilities. Appointing a Board of Directors, led by John Brown (director on CAT, Ardana, Protherics and Onyvax among others) and a Scientific Advisory Board, led by Prof David Rowlands. Establishing SingVax as an authority in the region for vaccines. SingVax staff gets regularly invited to speak on panels concerning Asia, including this year's Phacilitate Vaccine Forum in Munich and the World Vaccine Congress in Singapore. Setting up a facility in the Biopolis, Helios. It has over 4,300 sft of laboratory and office space. Forging partnerships with Crucell to licence its PER.C6 technology used in the JE vaccine development and OctoPlus to co-develop a single-shot JE vaccine. What is your product development and commercialization strategy? SingVax currently has two products in development; a JE vaccine targeted at the endemic and travel markets and an EV71 vaccine, to fight Hand Foot and Mouth Disease (HFMD), which is targeted at children before they enter childcare centers. SingVax is actively looking at in-licensing, in order to build up the company's product pipeline. The company's commercialization strategy is to seek development partners for its products and its key development capabilities. How do you intend to build upon your reach in the Asia Pacific region? To think of "reach" in terms of sales and distribution within the Asia Pacific is a bit early, as we are still in the product development stage. However, SingVax is looking to do clinical development within Asia, and we are currently exploring different countries to run such studies. As mentioned earlier, we are also looking at in-licensing and partnerships, so potential partners from the Asia Pacific are welcome. How much investment has gone into SingVax so far? Are you looking at scaling it up? How? Till date, including equity investment and grant support, we have received over $13 million. This has been funding the business. We obviously will need to continue to fund the business, in order to sustain our level of activities. So, we are considering a number of options, including Series B financing, M&A deals and new collaborations. What kind of market response do you expect to be there for JE and EV71 vaccines? The current JE vaccine market is estimated at $250 million. SingVax's JE vaccine is based on the inactivated whole JE virus particles, and the company aims to develop a single-shot vaccine. As such, SingVax's vaccine will have numerous advantages in terms of safety and compliance. EV 71 is the main causative virus of HFMD. There is currently no HFMD vaccine available, and the market opportunity for an EV 71 vaccine is estimated at $150 million. We target to have both our JE vaccine and EV71 vaccine within the clinic in 2008. Nandita Singh   ]]> <![CDATA["Our facility for manufacturing specialized enzymes and proteins, used in research, would be fully operational by December 2007"]]> https://biospectrumindia.com/news/95/2920/our-facility-for-manufacturing-specialized-enzymes-and-proteins-used-in-research-would-be-fully-operational-by-december-2007.html https://biospectrumindia.com/news/95/2920/our-facility-for-manufacturing-specialized-enzymes-and-proteins-used-in-research-would-be-fully-operational-by-december-2007.html Mon, 06 Aug 2007 11:34:00 +0530 New Page 1 "Our facility for manufacturing specialized enzymes and proteins, used in research, would be fully operational by December 2007" -Rajeev Soni, president and COO, PREMAS Biotech Pvt Ltd Dr Rajeev Soni, who has over 15 years of varied and in-depth experience in the biotechnology sector, has been instrumental in setting up several laboratories in the US, UK and India including the molecular biology facility at Naval Research Lab in Washington DC. Dr Soni is now on a mission to make PREMAS Biotech a leading integrated drug-discovery solutions company. He shares with BioSpectrum some of the plans of PREMAS. PREMAS Biotech was set up in November 2005 to provide integrated drug discovery solutions to the pharma and biotech organizations? In the past 20 months, how has PREMAS evolved and what are some of its key achievements? PREMAS Biotech was incorporated in November 2005 and, subsequently, it took nearly 16 months to set up the laboratories in Manesar, one of the most structured and well managed industrial towns of Haryana. The laboratories became ready for operation in March 2007. Some of the key achievements include setting up state-of-the-art laboratories for research in molecular biology and biotechnology with requisite support facilities; filing of provisional patents for applied research technologies such as diagnostic technology for infectious diseases and proprietary vectors for protein expression in bacterial, yeast and mammalian cells; hiring of scientific personnel and securing contracts from companies of national and international repute. What are some of your future plans? The plan is to be a partner of choice in providing drug discovery solutions to pharma companies, biotech companies, universities and research institutes. PREMAS Biotech's focus area is to become the leader in providing customized and innovative high quality research services and products. You also have plans to manufacture specialized proteins and enzymes. How is PREMAS Biotech progressing on this front? The facility for the manufacture of these specialized enzymes for research purposes would be fully operational by December 2007. We will have the capabilities to produce enzymes and proteins up to the scale of 1500 liters for research purposes only. The facility would be available for contract manufacturing for companies interested to produce proteins required for drug discovery research. You have also another important project, Applied Research for Technology Transfer (ARTT), in the pipeline. Could you share with us some of the developments on this project? ARTT is focused on several areas: Molecular diagnostics: Provisional patent has been filed and proof of concept demonstrated for the technology. Currently, we are performing experiments to increase the scope of the technology. Proprietary vectors: With the increasing emphasis on the development of novel bio-therapeutics in the global biotech industry, there is a need for the availability of multi-functional/multi-cassette vectors for rapid and directed cloning, integration, expression of proteins and assay development in various systems such as bacterial, yeast and mammalian cells. We have identified this as a focus area and are in the process of developing in excess of 60 such vectors for the above mentioned activities. Novel Bio-therapeutics: The goal here is to identify, validate and provide proof of concept for novel bio-therapeutics from bio-resources and then transfer the technology to a pharma/biotech company who can take this forward and develop the required drug. Currently, we are in the process of identifying potential bio-resources to isolate proteins that can act as therapeutics. The areas of interest entirely depends upon the requirements of our partnering pharma/biotech company to provide this technology transfer. We do not intend to have a conflict of interest with our customers by coming out with our own drug, be it a small molecule or a protein. What is the quantum of investments that have gone into the company so far and how did you raise your funds? Do you intend to raise further funds and how do you plan to raise the funds? We have already invested to a tune of $6 million. The funding is from a UK-based investment firm and is adequate at the moment. What have been your revenues in 2006-07 and what is your expectation by2010? Is it the services or products that account for the largest share of your income? As I mentioned earlier that we have started the operation in the month of March 2007, we are currently in the process of serving four customers for drug discovery services and products. We have a robust growth plan for both services and products and intend to reach significant revenues by 2010. Could you tell us more about your product development and manufacturing strategies? The product development is in the area on innovative research solutions as mentioned above. The manufacturing strategy is for the production of specialized enzymes and membrane proteins. In addition, the facility would be available to our customers for contract manufacturing of research products for drug discovery. Today, every biotech company starts as a global organization. What are your global plans and expansion strategy? Being an internationally funded company with strong international networking, and being one of India's EOU's for both manufacturing and services, we have a mandate to focus on the global biotech industry. How many people does PREMAS Biotech have today? And how difficult is it to find people and train the workforce? We currently have 25 people on board with most of them having both national and international experience. It has been challenging to find the personnel with appropriate expertise and risk taking ability to join a start up organization. We have been fortunate to have a talented group of scientists on board who have decided to walk the path with us on this exciting journey. The learning and experience has been extraordinary and fascinating. What are the current challenges that are effecting your growth and what are some of the steps that the government or industry can collectively take to address these challenges? One of the challenges is the talent gap that exists to deliver innovative, highly demanding research solutions. The government is already doing an astonishing job in encouraging industry-academia collaborations.   ]]> <![CDATA["I don't see any reason why India cannot emerge as a major center for clinical trials"]]> https://biospectrumindia.com/news/95/2189/i-dont-see-any-reason-why-india-cannot-emerge-as-a-major-center-for-clinical-trials.html https://biospectrumindia.com/news/95/2189/i-dont-see-any-reason-why-india-cannot-emerge-as-a-major-center-for-clinical-trials.html Mon, 06 Aug 2007 11:28:00 +0530 New Page 1 "I don't see any reason why India cannot emerge as a major center for clinical trials" -Thomas L Adams, president and CEO of ACRP Thomas L Adams, president and CEO of ACRP (Association of Clinical Research Professionals), was recently in India for the launch of the Bilcare Research Academy set up in partnership with Association of Clinical Research Professionals (ACRP). ACRP, an international association with more than 20,000 members, is headquartered in Alexandria, Virginia with a European office in Windsor, UK, and starting its Indian chapter in Pune. Pratima Harigunani from CyberMedia News caught up with Adams in this interview about whether the Clinical Trials syringe has hit the right vein here or not? Excerpts: If you were to take a stock of factors like regulatory environment, medical infrastructure, certifications, gene pool, disease pool, pharma industry, degree of specializations, patient consent system and costs, how would you rate the overall attractiveness of clinical trials in India? I don't see any reason why India cannot emerge as a major center for clinical trials. You have a well respected medical establishment and a pharmaceutical industry that is all ready recognized as a major player in the generic marketplace. Many of the diseases in the general population are the same as in the rest of the world and while certification is not currently prevalent in the country with appropriate education and training it can be. I believe certification is the yardstick by which India can assure that trials conducted here meet the same stringent standards that occur in the US and EU. How practical and fertile is the outsourcing concept for the CT industry? How does the Indian environment for CTs stand in comparison to countries like China, Vietnam and Thailand? The movement of CTs to an outsourced model by pharma is underway. It will be the preferred model in about five years if not sooner. Because the medical establishment is so highly regarded, growth in CTs will progress faster than in the other countries you mention. Additionally that English is universally used is a huge jump-start compared to other countries that you mentioned. Are the enrolment numbers and mix of volunteers satisfactory so far? Less than one percent of CTs are currently conducted in India. There is room for substantial growth. What made you come to India and where are you heading next in the subcontinent? What's your set of criteria about a country's selection? India and China were high on ACRP's list for expansion due to the reasons above and our belief that India is in an important place due to the art of medicine, strong experience with generics and reliance on English as a primary language. The main criteria that we use in determining when to enter a new market is our comfort level with finding a partner to oversee our affairs in the new country. Bilcare's commitment to ethical training and education made them a logical partner for us. We believe that together we will grow quickly here and in Southeast Asia. Other countries on the map include China and the Bilcare Academy expansion countries. Is the industry successfully tackling the issues of placebos, role of sponsors in CTs, futility terminations, registration and reporting of CTs to medical journals, CT registry, etc? How serious are these issues? The entire issue of CT registries and what they should contain are up in the air. ACRP has been on record as supporting a centralized registry for all clinical trials. The interest is there on the part of FDA and others but no one has stepped forward to design and pay for one and its maintenance. Perhaps with India's strong IT community this is something that could be undertaken here and exported over time. Any observations on the implications of human genome project? It opened the door for designer drugs. Now how do we afford them and what should the priorities be, is the next point. What is the latest hot spot in CTs in view of ethical debates across the globe? The two areas I'm asked about most often are: How do you insure informed consent when large portions of a potential population do not read or write? How do you insure global standards for CTs are met? So, what's the biggest challenge that you and your peers are currently dealing with? The need for education and certification exceeding our ability to provide it. What are the challenges, in particular, from the perspective of CR Professionals in the US and globally? Education and certification. If I sound like a broken record on this subject, it is intentional. Those are the only two methods to insure that people who are doing the trials know what they are doing and insure that patients have the protections they need and deserve.   ]]> <![CDATA[Animal-human chimera, the mixing and matching]]> https://biospectrumindia.com/news/95/2007/animal-human-chimera-the-mixing-and-matching.html https://biospectrumindia.com/news/95/2007/animal-human-chimera-the-mixing-and-matching.html Mon, 06 Aug 2007 11:21:00 +0530 New Page 1 Animal-human chimera, the mixing and matching Scientists believe creation of part-human part-animal creatures can help to study disease, advance areas such as fertility, and boost understanding of our basic biology. The mixing up and merging of species is not new to science. A multitude of creatures straddling the line between animal and human already exist in laboratories around the world. Technology allowed inserting one or two genes at a time into the germ line or genetic inheritance. More recently, artificial chromosome technology has allowed insertion of hundreds of genes at a time. Both techniques create what is called a "transgenic". For 20 years now, transgenic mice containing human genes in their genetic inheritance have been scurrying about in laboratory cages. Scientists believe that the creation of part-human part-animal creatures can help to study disease, advance areas such as fertility, and boost understanding of our basic biology. These creatures are called chimeras, and are defined as organisms that contain at least two genetically different groups of cells originating from different organisms. Different from hybrids, which are formed when one species' egg is fertilized with another species' sperm, such as the horse-donkey-cross mule, chimeras can occur between the same species or between different species and exist in nature or be created in the laboratory. Although fairly rare, chimeras made of two humans do exist, most commonly formed when non-identical twins fuse in the womb to create a single person. If a male embryo fuses with a female embryo, this can result in hermaphroditism, where a person has a mixture of male and female sexual organs. But, if the embryos are of the same sex, then there may be no obvious differences apparent at all. Interspecies chimeras It is the chimeras made from different species that are currently proving of most interest to scientists. Irving Weissman of Stanford University and his colleagues pioneered these chimera experiments in 1988 when they created mice with fully human immune systems for the study of AIDS. Later, the Stanford group and StemCells Inc., which Weissman co-founded, also transplanted human stem cells into the brains of newborn mice as preliminary models for neural research. And working with foetal sheep, Esmail Zanjani of the University of Nevada at Reno has created adult animals with human cells integrated throughout their body. Chinese scientists at the Shanghai Second Medical University in 2003 successfully fused human cells with rabbit eggs. The embryos were reportedly the first human-animal chimeras successfully created. They were allowed to develop for several days in a laboratory dish before the scientists destroyed the embryos to harvest their stem cells. The creation of the oddly named Geep in 1984, a creature formed by merging the embryos of a sheep and goat, opened the floodgates into an unprecedented area of research. And these interspecies chimeras can be created in a variety of ways. In the proposed stem cell research, although the animal egg has been emptied of its nuclei, tiny amounts of mitochondrial DNA would mix with the human nuclei and the resulting stems cells would be about 99.9 percent human and 0.1 percent animal--on the cusp of being chimeric. Other methods for creating chimeras include: Fusing embryos of different species together; Transplanted genes, cells, tissues or organs from one species into another; Or injecting stem cells from one species into a developing embryo or an adult of another species. Scientists say these interspecies creatures could help science in a number of ways--from making human stem cells and improving animal models to study disease, to one day, perhaps, creating organ or tissue factories for transplants into humans. And using chimeras also helps scientists to carry out experiments, such as those using developing embryos, which would be ethically difficult to perform on human beings. For 20 years, transgenic mice containing human genes in their genomes have been scurrying about in laboratory cages. These human genes were placed into the mouse genome and passed on to subsequent mice generations. However, several technical obstacles have limited the amount of human genes that are expressed in a mouse. Only a few human genes could be successfully inserted into the mouse genome at a time without interrupting essential mouse gene functions or creating a fatal combination. This may not be the end of the story, though, as the wedding of human embryonic stem cell biology and mouse developmental biology may allow for the creation of even more fascinating--and more mixed--human-mouse chimeras. Human stem cells could potentially be placed in a mouse embryo with the result that human genetic material alone would drive developing "human" tissues and organs in a mouse. Major research works In China, there are 29 goats running around on a farm with human cells coursing through their organs, a result of scientists dropping human blood cells into goat embryos. In Boston, US, scientists have transplanted human breast tissue onto mice to study the development of breast cancer. Esmail Zanjani at the University of Nevada, Reno is trying to grow a wide range of other tissues, such as insulin-producing islet cells for treating diabetes. St Kitts, Yale University researchers are injecting millions of human brain cells into the heads of monkeys afflicted with Parkinson's disease. While another American team recently showed it was able to grow immature human testicular tissue in mice. The researchers wanted to see if it would be possible to harvest sperm, for example from boys who had contracted cancer in childhood, from this tissue which could then be frozen and stored for later use. And whole organ research is also underway. Researchers have shown that it is possible to create a mouse with 95 percent of human liver cells, and other teams have created a mouse with a human immune system--both groups hope they can use the animal-human models to better understand the origins of disease. One of the latest chimeras to hit the headlines was created by scientists in Korea. They sparked controversy when they injected human embryonic stem cells into developing mouse embryos. The finding that these the cells were then distributed throughout the mouse's body, including the brain, caused public outrage, and the scientists later abandoned the experiments as the protests increased. New trends Until recently, most of these animals were created by inserting just one or two genes from one species into an animal of another species. However, the current trend is to insert more and more human DNA into an animal of another species. Newer techniques using yeast artificial chromosomes (YACs) and bacterial artificial chromosomes (BACs) allow insertions of up to 1/3 of a chromosome to create a transgenic animal. This YAC transgenic technology is currently being employed to create transgenic pigs for the purpose of developing organs for human transplantation (a technique known as "xenotransplantation"). If perfected, the technique could overcome some of the big stumbling blocks facing researchers who want to make tissues and organs for implants. It might yield significant quantities of just about any kind of cell or tissue, for instance, with no need to fiddle about with different culture conditions or growth factors. Instead, the host animal's own developmental program guides the injected human stem cells into their final roles. It would also allow doctors to obtain immune-compatible cells without having to create human embryos by therapeutic cloning. Human cells could be separated from the animal ones simply by modifying existing cell-sorting machines. Providing the method really does produce normal human cells, they would not be rejected. And any stray animal cells would be killed off by the recipient's immune system. The chimeric models would allow the effects of various factors on a gene's function to be tested in a whole animal rather than merely in a test tube or cell. By inserting human DNA into an animal such as a mouse, medical researchers are provided with important information, which may help them in their efforts to conquer human disease. The formation of these hybrids is a relatively recent phenomenon with some scientists say the more humanlike the animal, the better research model for testing drugs or possibly growing "spare parts," such as livers, to transplant into humans. Watching how human cells mature and interact in a living creature may also lead to the discoveries of new medical treatments. The successful application of these techniques has raised important ethical questions. For example, should there be a limit to the amount of human DNA inserted into an animal? Should such limits be enforced for transgenic research, which has great therapeutic benefit for human beings? How would such "therapeutic benefit" be determined? Jahanara Parveen   ]]> <![CDATA[Focus on treating TB steps up]]> https://biospectrumindia.com/news/95/4903/focus-on-treating-tb-steps-up.html https://biospectrumindia.com/news/95/4903/focus-on-treating-tb-steps-up.html Mon, 06 Aug 2007 10:22:00 +0530 New Page 1 Focus on treating TB steps up Over the past few years, several factors have emerged, which are contributing to increased R&D activity in Tuberculosis (TB) therapy. No new drug class has been introduced for over 30 years and the current market is dominated by generic products. There are only a few companies that market TB therapies. Eli Lilly, AstraZeneca, Sanofi-Aventis, Pfizer and Sandoz (Novartis's generics division) are some the global companies that have a focus on TB therapies. But in the past 10â€“15 years, R&D activity in TB therapy has increased for several reasons. TB Alliance Portfolio Discovery (Organization) Nitroimidazole Analogs (University of Auckland and University of Illinois at Chicago) Quinolones (KRICT/Yonsei University) Multi-Functional Molecules (Cumbre) Bacterial Topoisomerase Inhibitors (GlaxoSmithKline) InhA Inhibitors (GlaxoSmithKline) Pleuromutilins (GlaxoSmithKline} Focused Screening - 2 projects (GlaxoSmithKline) Riminophenazines (Institute of Materia Medica/BTTTRI) Screening and Target Identification (AstraZeneca) Malate Synthase Inhibitors (GlaxoSmithKline/Rockefeller Texas University, A&M) New Targets (University of Pennsylvania) Protease Inhibitors (Queen Mary, University of London) Proteasome Inhibitors (Cornell University) Protein Synthesis Inhibitor (Pharma) Clinical Development (Organization) Moxifloxacin (ethambutol sub.) (Bayer) Moxifloxacin (isoniazid sub.) (Bayer) Nitroimidazole PA-824 (Chiron/Novartis) The economic impact of TB is huge. More than 75 percent of TB deaths affect the population aged between 15â€“54 years, the most economically active segment. TB is estimated to cause lost productivity of 4â€“7 percent of GDP and to deplete the economies of developing countries by a total of $12 billion per year. The burden of TB in India is indeed staggering by any measure according to TB India 2007 Report. More than 80 percent of the burden of TB is due to premature death, as measured in terms of disability adjusted life years (DALYs) lost. About 17 crore workdays are lost due to the disease. And the annual economic cost of TB to the Indian economy is at least $3 billion (more than Rs 13,000 crore). Multi-drug resistance is another major problem. Cases of extremely drug resistant TB (XDR-TB) that cannot be effectively treated with first- or second-line therapies have been reported worldwide, including in the US. WHO-led global control programs aim to halt the rise in TB incidence by 2015 and to halve the 1990 prevalence and morbidity rates globally. The costs of reaching these targets will be around $56 billion over 10 years and WHO anticipates that funding of only around 45 percent of this total will be available. TB drugs The current gold-standard treatment for active TB is a six-month regimen with rifampicin and isoniazid, supplemented in the initial two months with pyrazinamide and either ethambutol or streptomycin. This combination has the three properties required for effective TB management: antibacterial activity, capacity to inhibit the development of resistance and efficacy against persisting organisms. According to some estimates, the sales of generic rifampicin in the US is $15-16 million. The WHO established a Global Drug Facility (GDF) in 2001 to procure and supply TB drugs to low-income countries. Svizera Europe, Lupin Pharmaceuticals, Cadila, and Strides-Sandoz are the designated preferred suppliers. The WHO GDF alone supplied $28 million worth of TB drugs to 55 countries in the last one to two years. Lupin Pharmaceuticals manufactures and markets several branded generic TB treatments in high-burden markets and is also involved in the development of new therapies. Its lead molecule, LL-3858 is in Phase I trials. A report by the TB Alliance estimated that in 2000 the market was worth between $412-470 million per year. This figure includes an estimated $275â€“318 million worldwide private TB market (based on IMS Health sales data for anti-TB drugs), an estimated $125â€“140 million tender market and an estimated $12.5 million for drugs to treat MDR-TB. It is estimated that the global TB market would grow to between $612â€“630 million by 2010. The increased R&D activity now simmers hope that a number of new drugs for TB treatment would be found by 2015. There are some hopeful signs. AstraZeneca has a TB research facility in Bangalore focused on finding new therapies for TB. Novartis has a facility in Singapore for research in TB. Lilly MDR-TB Partnership is a comprehensive public-private initiative led by Lilly to address the expanding crisis of multidrug-resistant tuberculosis (MDR-TB). It aims to transfer Lilly technology for the production of two key MDR-TB drugs (cycloserine and capreomycin) to four partner companies in high-burden MDR-TB countries. Lilly's total contribution to the MDR-TB partnership so far is around $135 million. In July this year, the TB Alliance announced an innovative approach to accelerating the identification and development of new, optimized, combination drug regimens for TB. In active TB, all therapies must involve multiple drugs to prevent the development of resistance. The new, aggressive strategy will survey potential TB drug combinations in preclinical models, well before clinical evaluation, an approach that has never been employed previously in TB drug development. This new plan has the potential to significantly decrease the time it will take to develop novel optimized, combination therapies for TB. The conventional approach to TB drug development evaluates potential compounds sequentially, substituting them individually into the existing regimen. Each alteration is studied in clinical trials, which take at least six years to complete Phase IIB and III. All told, a regimen consisting of completely new drugs would require more than 24 years of clinical development - too long to wait. To jump start this new, aggressive approach, the TB Alliance is preparing to move PA-824--its first novel TB drug candidate--into TB patients for the first time later this year, while also working with its partners to advance moxifloxacin, another new TB treatment option with the potential to shorten treatment time--into large scale, Phase III clinical trials. PA-824 is a nitroimidazole, a novel class of anti-bacterial agents for the treatment of TB. As a potential TB drug, it has many attractive characteristics - most notably its novel mechanism of action, its activity in vitro against all tested drug-resistant clinical isolates, and its activity as both a potent bactericidal and sterilizing agent in mice. With the completion of several Phase I trials in healthy volunteers, PA-824 will enter a Phase II Early Bactericidal Activity study in TB patients in South Africa. Moxifloxacin is a fluoroquinolone, a subset of the quinolone class of antibiotics. Developed by Bayer HealthCare AG, moxifloxacin has demonstrated efficacy for the treatment of acute respiratory and some skin infections. It also has an excellent safety record, having been used more than 60 million times, in 104 countries. Moxifloxacin's mechanism of action differs from those of the first-line drugs currently used to treat tuberculosis, and it has demonstrated activity against TB in both in vitro and in vivo studies. The REMoxTB Phase III clinical trial will be led by investigators at the University College London and the British Medical Research Council as part of a global clinical trial program coordinated by the TB Alliance and Bayer Healthcare AG. To advance this new paradigm of drug combination development, the TB Alliance has initiated discussions with regulatory agencies including, but not limited to, the US Food and Drug Administration, the European Medicines Agency and the South African Medicines Control Council. The TB Alliance's "Open Forums on Key Regulatory Issues in TB Drug Development" will also continue in support of these discussions, and other issues related to accelerating TB drug development and approval. "India accounts for 30% of the total global TB burden" -Dr PR Narayanan, Director, TRC, Chennai Tuberculosis Research Centre (TRC), Chennai, is one of the International Centers for Excellence in research, funded by National Institute of Allergy and Infectious Diseases (NIAID) and National Institutes of Health (NIH), USA and completed 50 years in 2006. Dr PR Narayanan, director, TRC, Chennai, shares his thoughts with BioSpectrum on the TB cases in India. What is the status of tuberculosis (TB) in India? The estimated number of bacillary cases was 3.8 million, the number of abacillary cases was estimated to be 3.9 million and that for extra-pulmonary cases was 0.8 million giving a total burden of 8.5 million. India, at present, accounts for 30 percent of the total global TB burden. What is the percentage of XDR and MDR-TB cases prevalent in India and which are the drugs successful against these? The MDR prevalence in Indian settings, based on our studies, is as follows. It is 1-3 percent in new cases, among treated cases 12-14 percent and among CATII failures 33-40 percent. The exact prevalence of XDR-TB is not known but it is assumed to be 2-4 percent of MDR-TB cases. The drugs that are used in the treatment of MDR-TB are quinolones, aminoglycosides, thiomides, cycloserine, PAS, thiacetazone, pyrazinamide and ethambutol. XDR management is not yet defined. Drugs like PAS, thiacetazone, pyrazinamide and ethambutol may be of use. To what extent are the presently available drugs combating TB? Currently available anti-TB drugs are considered to be 100 percent regimens (establishing cure among all patients harboring sensitive organisms) under trial conditions and currently the program is able to cure about 85 percent of new patients and 50-70 percent of already treated patients. The program also helps the patients by providing Directly Observed Therapy within two kilometers of their residence. These drugs are freely available and the drug logistics of the program are good in all parts of our country. What are some of the recent projects going on at TRC and which are the newer drugs in the pipeline? The ongoing project of TRC is efficacy and safety of immunomodulator (Mycobacterium W) as an adjunct therapy in category II pulmonary tuberculosis. Newer quinolones ( Moxifloxacin ) and compounds from Lupin and Tibotec are some of the new products. How successful has India been with the anti-TB approach? The Revised National Tuberculosis Control Program (RNTCP), based on the Directly Observed Therapy Strategy (DOTS), began as a pilot in 1993 and was launched as a national program in 1997. Rapid RNTCP expansion began in late 1998 and the entire country was covered under DOTS by March 24, 2006. This can be considered as the first major achievement. As of 25 July 2007, a total of 7,321,357 patients were treated and 1,317,844 lives were saved. Every day in India, under the RNTCP, more than 15,000 suspects are being examined for TB, free of charge. The diagnosis of these patients and the follow-up of patients on treatment are achieved through the examination of more than 50,000 laboratory specimens. As a result of these examinations, each day, about 3,500 patients are started on treatment, stopping the spread of TB in the community. In order to achieve this, more than 600,000 health care workers have been trained and more than 11,500 designated laboratory Microscopy Centers have been upgraded and supplied with binocular microscopes since the inception of the RNTCP. As a result of rapid expansion in diagnostic facilities, the proportion of sputum- positive cases confirmed in the laboratory is double that of the previous program and is on par with international standards. Despite the rapid expansion, overall performance remains good and in many areas is excellent. Treatment success rates have tripled from 25 percent in the earlier program to 86 percent in RNTCP The operational feasibility of DOTS in the Indian context has been demonstrated, with 8 out of 10 patients treated in the program being cured, as compared with approximately 3 out of 10 in the previous program. Jahanara Parveen     "Lilly wants to empower communities battling with MDR-TB" Lilly's philanthropic contribution to the global cause of multidrug-resistant tuberculosis (MDR-TB) management touched a whopping $135 million in 2007. In an interview, Sunita Prasad, consultant (MDR-TB & CSR), Eli Lilly, talks about Lilly's continued efforts in this direction. Excerpts: How many people are affected by MDR-TB in India every year? The data on the number of patients is more anecdotal and less reliable. However, the WHO report of global TB control indicates that there are approximately 44,600 MDR-TB patients in India every year. Some other figures say it is slightly higher than this. Globally India and China are responsible for about 50 percent of the MDR-TB cases. China leads in the number of MDR-TB cases with India following closely and Russia and South Africa being other high burden countries. India accounts for 20 to 22 percent of the global pie. The MDR-TB initiative is in its fifth year now since its inception in 2003. Please elaborate on this commitment. In 2003, we started with work on transfer of technology which was to ensure drug supply at concessionary prices, and then various efforts were made to establish Centers of Excellence (CoEs) in research and training and developing the training tools required for healthcare professionals for treatment, surveillance and infection control. Towards this, we have partners such as International Council of Nurses (ICN), International Federation of Red Cross and Red Crescent Societies (IFRC), International Hospital Federation (IHF), Harvard Medical School and Partners in Health (PIH), Purdue University (USA), TB Alert & TB Survival Project, Center for Disease Control (CDC), World Economic Forum (WEF), World Health Organization (WHO) and World Medical Association (WMA). What is Lilly's contribution to drug development for TB treatments? Lilly has announced a public-private partnership that would conduct early phase discovery research for new medicines including emerging resistant strains. The partnership will be a not for profit, drug research organization based in Seattle, USA and would draw on the resources of Lilly as well as leading researchers and organizations. Lilly would open its library of more than 5,00,000 medicinal compounds to researchers, who will test and screen them for possible TB treatments. Other partners contributing to the effort include Afya World Medicines, Infectious Disease Research Institute, Jubilant Biosys, Merck & Company, the Seattle Biomedical Research Institute, and the University of Washington, Department of Global Health. What are the challenges in combating MDR-TB in a country like India? Treating MDR-TB is a challenge in itself, as the treatment duration is long. The drugs have severe adverse reactions and adherence and compliance can become an issue. Treatment for normal TB takes 6-12 months, whereas for MDR-TB it is more than 24 months. As soon as the person feels slightly better, he/she stops taking the drugs. So this non-adherence or non-compliance may lead to development of further resistance. What is Lilly's approach to tackle MDR-TB? In India, we have a very robust national tuberculosis program known as RNTCP II . The RNTCP Phase II program looks at MDR-TB as a standard of care issue, that is to say that they emphasize that the best prevention of a growing problem of MDR-TB would be to have a strong and well performing Directly Observed Therapy Strategy (DOTS)â€“with high detection and cure rates. We are trying to support the GoI's initiative in various ways, which is again based on what we are doing globally. This includes transfer of technology, increasing the availability and supply of drugs, training healthcare workers and surveillance of programs for community support. Globally we have four focus countries -- China, South Africa, Russia and India. In each of these we have technology transfer partners to produce cycloserine and capreomycin, Lilly's two legacy drugs. The partners are Aspen Pharmacare in South Africa, Hisun Pharmaceutical in China, Shasun Chemicals and Drugs in India, and SIA International in Russia. Lilly wants to empower communities battling with the disease and it believes in the Chinese proverb, "If you give a man a fish, you feed him for a day, but if you teach a man to fish, you feed him for a lifetime." Who are your partners in the battle against MDR-TB? We are working with the government, institutions and some media partnerships are on the way. We are going to partner with IMA (Indian Medical Association) in taking forward the guidelines to private practitioners. Private practitioners are very crucial stakeholders in TB treatment because in India 50 percent of the population goes to private practitioners who don't follow the approved regimen. If wrong prescriptions are given and non-adherence resistance develops, a patient might develop MDR-TB. We would also be working with the government at the Central and state level. We would be working with media for greater communication to reduce the stigma attached to the issue. Also we would be working with country-based organizations and an international organization, TB Alert to take this forward in community-based settings. Shalini Gupta ]]> <![CDATA[A Lifeline for Life Sciences]]> https://biospectrumindia.com/news/95/7327/a-lifeline-for-life-sciences.html https://biospectrumindia.com/news/95/7327/a-lifeline-for-life-sciences.html Sat, 07 Jul 2007 15:26:00 +0530 New Page 1 A Lifeline for Life Sciences The biotech industry is gaining size. The $2 billion revenue in the last fiscal year, with exports crossing the $1.2 billion mark is a clear sign of this. India's pharma industry too has done well with nearly $8 billion in revenues. So the life sciences sector is emerging as a key industrial segment in the national economy. There is all round optimism that the life sciences industry could bring more laurels to the country in the coming decades. While a few big players will dominate the sectors, as is the trend elsewhere, the real innovation will take place in small companies, set up by first-time entrepreneurs. This is happening in India too and hundreds of scientists have stepped out of the labs in recent years to start their own companies. Such entrepreneurs, around the world, face a shortage of funding to support the early stages of development. It is no different in India. Responding to request from the life sciences industry, Finance Minister Palaniappan Chidambaram has redirected tax concession to VC funds to investments in high risk sectors like biotech, pharma, nanotech etc in a few months. During the June Bangalore Bio event, Chidambaram has promised to look at mechanisms to set up a separate Life Sciences Fund, if the earlier measures don't work towards channelizing VC funds to life sciences. Governments around the world have tried different methods to achieve the same objective. One of the most successful example is that of Japan. The Japanese government announced special funding schemes in 2003 to spur innovation in life sciences and encourage its researchers to spin out companies based on technologies developed in publicly-funded institutions. This scheme was a phenomenal success. The government's target of spinning out 1,000 companies in three years was overachieved in two years itself and more than 1,500 life science companies have been set up between 2003-06. According to Japan's leading VC investor, JAFCO, over a dozen companies have even gone public in the last three years through this scheme. In fact now JASDAQ is planning to set up a separate market for life science companies similar to the Mother's Stocks run for innovative companies by the Tokyo Stock Exchange. The Manmohan Singh government which has adopted some of the progressive tax laws from Australia in recent years could look at the Japanese model for Indian life science companies. Studies by BioSpectrum reveal that the country requires about Rs 200-300 crore overall about 100 biotech companies through the early stages of their development. Each company requires Rs 2-3 crore to cross the first hurdle to become attractive for venture capitalists. Meanwhile, mirroring the 31 percent growth of the biotech industry, the key segment of BioSuppliers has grown by an identical percentage in 2006-07. The BioSpectrum-ABLE Top 20 BioSuppliers is list is available in this issue. Biotech companies have had many strategic partnerships and mergers and acquisitions in recent years. A special study by the Indian Institute of Management (IIM), Bangalore, has looked at the impact of these alliances on the industry. The preliminary results of the IIM survey, done as part of the 5th BioSpectrum-ABLE Biotech Industry Survey is also presented in this issue. Other highlights in this issue include the coverage of three major biotech events, which have taken place around the world in recent weeks-BIO Boston, Bangalore Bio and BioJapan. With over 20,000 business visitors, BioJapan, in its 6th edition has clearly emerged as Asia's largest biotech events. Indian biotech industry has a lot of catching up to do on this count and probably the only way to match this is to have a India Bio event, rotated between the major biotech clusters to give the Indian industry a much higher international profile than it gets now through 4-5 smaller events. Are the industry leaders listening? <sureshn@cybermedia.co.in> ]]> <![CDATA[Biotech Partner]]> https://biospectrumindia.com/news/95/2723/biotech-partner.html https://biospectrumindia.com/news/95/2723/biotech-partner.html Sat, 07 Jul 2007 15:14:00 +0530 New Page 1 Biotech Partner Medi Spec India is virtually a ISO certified biotechnology partner, offering products such as microplate instrumentation, gel documentation, DNA synthesizers, lab equipments, water baths, and microbial contamination detection systems. CEO: Vipul Chhatbar (MD) Revenue: Rs 23 crore Address: Unit 223, Link Way Estate, New Link Road, Malad (West), Mumbai - 400 064 Tel.: +91-22-2873 9944 / 2873 4567 Fax: +91-22-2875 9944 Website: www.miil.in Medi Spec India Ltd (MIL) is involved in offering products for life sciences organizations. Its products include microplate instrumentation, gel documentation, DNA synthesizers, lab equipments, water baths, and microbial contamination detection systems. Its sales turnover has increased to Rs 23 crore in 2006-07. The figure includes Rs 22.2 crore from trading activities and Rs 80 lakh from the sales of its own products. It has registered growth of over 52 percent in 2006-07 compared to last year. Its sales turnover from instrumentation and supplying reagents for the year 2005-06 stood at Rs 15.10 crore against the previous year's sale of Rs 11.5 crore. The sales turnover of MIL is expected to touch Rs 30 crore for 2007-08. MIL has recently been appointed exclusive manufacturers' representative by NUAIRE INC, USA. Nuaire is one of the leading supplier and manufacturer of CO2 incubators, biosafety cabinets and deep freezers. Its major achievement has been paving way for US-based BioTek to directly enter India as BioTek Instruments India. BioTek is one of the top suppliers of microplate Instrumentation product line, which include readers, washers, fluorescence and luminescence and liquid handling products. Other companies represented in India include UVP â€“ Ultra Violet Products for gel documentation/molecular biology product line, CELSIS for microbial contamination detection systems, Fisher Scientific UK (now Thermo Fisher), a one-stop shop for all laboratory supplies, Nickel Electro, well known for Clifton brand of water baths. MIL provides application and technical support to all its customers in the market segment that include biotechnology, genomics, pharmaceuticals - quality control, R&D and drug discovery laboratories, bioresearch institutions, government research institutes, universities and private sector research organizations, agricultural institutes, defense establishments, veterinary and poultry institutes, clinical and medical research labs. MIL operates out of all major cities like Chennai, Delhi, Kolkata, Bangalore, Hyderabad, Pune, Chandigarh, Ahmedabad and Lucknow and its head office is in Mumbai. This ensures close proximity to all its customers. MIL also offers sales, technical and application support to neighboring countries like Nepal and Bhutan. ]]> <![CDATA[Think Globally, Act Locally]]> https://biospectrumindia.com/news/95/6103/think-globally-act-locally.html https://biospectrumindia.com/news/95/6103/think-globally-act-locally.html Sat, 07 Jul 2007 15:11:00 +0530 New Page 1 Think Globally, Act Locally Eppendorf believes in two fundamental strategies: concentration on lab products and systems with a focus on biotechnology; transformation from a regionally oriented enterprise into a globally operating group. CEO: V Sankaranarayanan Revenue: Rs 29 crore Start-up Year: 2003 Address: Doshi Towers, 4th Floor, 156 Poonamallee High Road, Kilpauk, Chennai â€“ 600 010 Tel.: 91-44-42111314/42111341 Fax: 91-44-42187405 Website: www.eppendorf.co.in Eppendorf is a biotech company which develops, produces and distributes systems for use in life sciences research laboratories worldwide. Its product range includes pipettes, dispensers and centrifuges as well as consumables such as micro test tubes and pipette tips. In addition, Eppendorf provides instruments and systems for cell manipulation, automated devices for liquid handling, complete equipment for DNA amplification and biochips. Eppendorf India, with its headquarters in Chennai is the Indian arm of Eppendorf AG, Germany. Eppendorf facilities include an applications lab and a training center apart from sales and marketing offices. Eppendorf India trains customers on specific high-tech topics such as realtime PCR and liquid handling automation. The lab also serves for demonstration purposes as a continuing exhibition of state-of-the-art research tools. In March 2007, Eppendorf India launches ep Dualfilter TIPS. The new Eppendorf ep Dualfilter TIPS are the first filtertips with a two phase filter for contamination protection. The tips are manufactured to the highest possible quality from pure, non-recycled materials under cleanroom conditions. They are characterized by defined flow dynamics, low wettability and high thermal stability. They are certified pyrogen free and PCR clean (free from human DNA, DNase, RNase and PCR-inhibiting substances). ep Dualfilter TIPS contains well-defined different pore sizes within the two filter layers. The white layer which faces the sample retains drops, splashes and aerosols. The blue layer above it forms a highly-effective double barrier, that reliably binds even biomolecules. ep Dualfilter TIPS are not yet available in all countries. In a novel venture, in association with Millipore India and Metrohm, Eppendorf India has launched Science Trek, a state-of-the-art laboratory on wheels for students. Science trek will visit colleges and other educational institutes all over the country. The mission of science trek is to showcase and demonstrate the latest lab equipment to students. Apart from this, Eppendorf India offers various seminars and hands-on training courses for student to help them keep their knowledge up to date on PCR, Realtime PCR and Liquid handling. Keeping in mind the increasing demand from research, medicine and industry, the Eppendorf India Training Center offers a wide range of courses and seminars. ]]> <![CDATA[Flow Tech Leader]]> https://biospectrumindia.com/news/95/1951/flow-tech-leader.html https://biospectrumindia.com/news/95/1951/flow-tech-leader.html Sat, 07 Jul 2007 15:08:00 +0530 New Page 1 Flow Tech Leader Alpha Laval manufactures and supplies a wide range of key components and systems in separation, heat transfer and flow technology. CEO: Nish Patel (MD) Revenue: Rs 30 crore Start-up Year: 1937 Address: Mumbai Pune Road, Dapodi, Pune â€“ 411 012 Tel.: 91- 20- 24116100, 27107100 Fax: 91-20-7147711 Website: www.alfalaval.co.in Alfa Laval India is a supplier of plate and spiral exchangers, centrifugal separators and decanters, flow equipment and complete projects and systems. There has been no change in the sales turnover of Alfa Laval from its life sciences division during 2006-07 as it remained Rs 30 crore. In 2005-06, its sales from life sciences division dropped to Rs 30 crore over the previous year's turnover of Rs 42 crore. In 2004-05, it got a major order from Biocon that increased its life sciences sales turnover to Rs 46 crore. Its total sales turnover stood at Rs 593.48 crore (year ending December 2006). The company officials feel that the rapid increase in capacity additions witnessed in the past in biotechnology will not continue for sometime though the business in biotechnology is expected to grow at a lower rate. Alfa Laval India was awarded GMU (Group Manufacturing Unit) status by Alfa Laval, Sweden, to manufacture centrifugal separators and decanter centrifuges for exports to Alfa Laval Sweden, Japan, Spain and Denmark. Alfa Laval India received ISO 900:2000 certification from Lloyds Register Quality Assurance - LRQA (UK) for its manufacturing units and after-sales services. Alfa Laval offers customized and comprehensive process systems /solutions such as cell culture reactors, clean in place, formulation, separation and filtration, high purity water, media and buffer prep and waste in activation to the biotech industry. During 2006, Alfa Laval India had an order intake of SEK 900 million and approximately 1,000 employees. In the recent years, Alfa Laval also has established a wholly owned engineering company in India that supports the Group. In May 2007, Alfa Laval AB increased its share of ownership in the Indian company from approximately 64 percent to approximately 77 percent. The financial investors hold the remaining total shares. Alfa Laval India is the first company to bring in single fermenter technology to India in the late 1980s. It has entered into a tie-up with US-based Katzen International to bring vapor phase molecular sieve technology. Its fuel ethanol program has been gaining prominence in Asia and South East Asia. Including India, it had installations in Vietnam, Thailand and Indonesia. ]]> <![CDATA[Instrumental Advances]]> https://biospectrumindia.com/news/95/2467/instrumental-advances.html https://biospectrumindia.com/news/95/2467/instrumental-advances.html Sat, 07 Jul 2007 14:59:00 +0530 New Page 1 Instrumental Advances Owing to various collaborations, during 2006-07, the revenues of Imperial Life Sciences were Rs 39. 25 crore, high from an expected Rs 35 crore. CEO: Suresh Kumar Gupta Revenue: Rs 39.25 crore Start-up Year: 1992 Address: Plot No. 463, Sector 37-II, Pace City II, Gurgaon Tel.: 91-124-4559800-99 Website: www.imperialls.com E stablished in 1992, Imperial Life Sciences (ILS) is in the business of instrumentation, reagents, software and other consumables, providing complete solutions for laboratories working in genomics, proteomics, drug discovery and bio-production process. It is the exclusive representative for around 48 global players in India like Agilent Technologies, Invitrogen Corporation (Gibco, Molecular Probes, Dynal, Caltag, Biosource, Zymed), IDT, CBS Scientific, Amresco, Fitzgerald and various others. During 2006-07, the company's revenues were Rs 39.25 crore, high from an expected Rs 35 crore, owing to various collaborations. Last year it had registered revenues worth Rs 26.88 crore. So the year has been good in terms of growth. This was basically due to the closing of deals with Agilent Technologies (November 2006), Invitrogen (January 2007) and Caliper, each to the tune of around Rs 1.5 crore. In terms of segmentwise break-up, cell culture registered the maximum growth reaching revenues worth Rs 785 lakh in 2006-07, up from Rs 198 lakh in 2005-06. Revenues from instrumention and lab equipment almost doubled from Rs 695 lakh (2006-07) to Rs 845 lakhs. The company is a life sciences provider with a wide range of products, more so with its association with Invitrogen that itself has acquired seven companies. The new product segments that have been added include bioproduction (raw material for vaccines), high end instrumentation (automated liquid handling systems), thus lending specialized products. Hence the company can take a project from the first phase of genomics research to the last phase of data integration. Imperial Life Sciences has four product segments - bioproduction, genomics, molecular biology and immunology and clinical site. It has recently started custom services in the field of genomics, proteomics and cell biology mainly Q-PCR for Real time analysis of PCR, Bioanalyzer for analysis of DNA, RNA, proteins and cells, Speed Cycler, the fastest thermal cycler in the world, iBlot for Protein transfer in just 7 minutes, automated DNA sequencer, automated DNA workstation, liquid handling systems and bioinformatics. ILS will soon be introducing custom services for microarrays. The company has seen some major deals including one with Reliance Life Sciences for around Rs 3 crore for bioproduction, University of Hyderabad for their genomics segment, a cancer project with MAHE-Manipal and CCMB, Genova, Serum Institute of India. ILS also wants to position itself in application support in order to acquaint people with technology by doing contract research services and training workshops and camps for students and teachers to have hands-on experience with these technologies. ILS plans to become a total solution provider and a one stop-shop to the Indian scientific community. n ]]> <![CDATA[Molecular Networking]]> https://biospectrumindia.com/news/95/2395/molecular-networking.html https://biospectrumindia.com/news/95/2395/molecular-networking.html Sat, 07 Jul 2007 14:52:00 +0530 New Page 1 Molecular Networking Genetix represents world leaders for supply of kits, reagents, laboratory plasticware and filterware. It has the largest distribution network of branch offices and over 30 distributors across India and in South East Asia. CEO: Arun Prakash Revenue: Rs 51 crore Start-up Year: 1991 Address: 71/1, Shivaji Marg, New Delhi-110 015 Tel.: 91-11-41427031 Fax: 91-11-25419631 Website: www.genetixbiotech.com Genetix Biotech Asia provides some of the global brands for molecular cell biology kits, reagents, tissue and cell culture serum/media, plasticware, chromatography media/columns, and sophisticated instruments. It initially started as an indenting company for marketing and providing technical support to Indian customers for all the products in its portfolio. In 1996, Genetix took advantage of growing market in private sector and reduction in custom tariffs to import, for 'stock and sell', products from Nalgene, Nunc, Clontech, Qiagen, Hyclone, Pierce, Amresco, SantaCruz and others. The company registered an approximate growth of 30 percent in the FY 2006-2007 up from Rs 40.1 crore last year to close at Rs 51 crore this year. The main growth drivers were work on several international projects, the prestigious one being with Oxford University, UK on genotypic studies. The company services two key segments of the market, the research segment and the industry, specifically the biopharma industry, both for R&D and production. It is also one of the key suppliers to almost all vaccine and recombinant protein manufacturing companies which have been responsible for most of the sales this year. Genetix Biotech stocks and sells over 15,000 lines of products for some of the best manufacturers such as Qiagen GmbH, Fermentas Life Sciences, Ambion, Operon Biotechnologies GmbH, Amaxa GmbH, Whatman Biometra GmbH, Nalge Nunc International,, Nunc A/s, Tosoh Bioscience GmbH, Santacruz Biotechnolgies and many others. It recently set up a full-fledged molecular biology and cell culture laboratory for in-house training, customer demonstration/training and quality control backup. This facility in future is to be utilized for running PCR courses for private diagnostic laboratories, develop molecular diagnostic products for infectious diseases and take up contract research. The company plans to launch a whole range of bioseparation products which includes filtration, chromatography, ultrafiltration under the Genetix brand, rather than other company products. It is also looking at functioning of the contract research laboratory for clinical research. ]]> <![CDATA[Image Icon]]> https://biospectrumindia.com/news/95/1070/image-icon.html https://biospectrumindia.com/news/95/1070/image-icon.html Sat, 07 Jul 2007 14:49:00 +0530 New Page 1 Image Icon DSS Imagetech extends the horizon of traditional microscopy and provides complete imaging solutions for microscope users. Its vision is to extend itself to a precision optimal manufacturing company. CEO: Arvinder Dhingra Revenue: Rs 53.99 crore Start-up Year: 1965 Address: A-5, Mohan Cooperative Industrial Area, New Delhi-110044 Tel.: 91-11-26950325 Fax: 91-171-26959382 Website: www.dssimage.com The DSS Group of Companies includes Olympus India and DSS Imagetech. It is a 45-year-old company with a turnover of approximately $13 million. The company's revenues are growing by 30 percent every year. It has registered an impressive growth of Rs 53.99 crore in FY 06-07 as compared to Rs 41.29 crore in its overall revenues segment last year. The life sciences division grew by 50 percent and the microscopy division grew by 31 percent. It has grown from Rs 20 crore to Rs 50 crore in the last two years and plans to grow to Rs 100 crore in the next three years. It attributes the growth to a good product portfolio, good services and the application in terms of training people in new technologies. It is only company that is facilitating the transition of molecular biology from research to diagnostics primarily because of the association of three major companies â€“ Olympus (microscopy), Genomic Solutions (microaaray), Abbott and Dako (flowcytometer) The total number of microarray installations were 28-32 in the last three years. In the last two years, DSS Imagetech and Genomic Solutions were rated as having the largest market share in the microarray segment. During the last one year, DSS has focused on being identified as a manufacturing company first and then a supplier. The company came up with a 50,000 sft manufacturing facility at Noida in the beginning of 2007 that was inaugurated by the CEO of Olympus worldwide. DSS Imagetech has a market share of 35-40 percent in the Pre MALDI segment. The company has a 70 percent market share in the open microarray system. DSS Imagetech now has also come up with training services in the field of molecular diagnostics, which include training on IHC and FISH as of now, with plans to expand into other biotechnological fields. DSS Imagetech wants to extend itself to a precision optimal manufacturing company in terms of it vision. It wants to bring molecular biology close to the common person's life by applying it to the molecular diagnostics area as a part of its future plans. ]]> <![CDATA[Healthy Venture]]> https://biospectrumindia.com/news/95/2486/healthy-venture.html https://biospectrumindia.com/news/95/2486/healthy-venture.html Sat, 07 Jul 2007 14:45:00 +0530 New Page 1 Healthy Venture GE Healthcare's broad range of products and services enable healthcare providers to better diagnose and treat cancer, heart disease, neurological diseases, and other conditions earlier. CEO: T Ravindar (CMD) Revenue: Rs 61.50 crore Start-up Year: 1994 Address: FF3, First Floor, Palani Centre, 32, Venkatnarayana Road, T Nagar, Chennai 600 017 Tel.: 91-44-434 0747 Fax: 91-44-432 3770 Website: www.gehealthcare.com GE Healthcare provides transformational medical technologies and services that are shaping a new age of patient care. Its expertise in medical imaging and information technologies, medical diagnostics, patient monitoring systems, performance improvement, drug discovery, and biopharmaceutical manufacturing technologies is helping clinicians around the world re-imagine new ways to predict, diagnose, inform, treat and monitor disease, so patients can live their lives to the fullest. GE Healthcare's broad range of products and services enable healthcare providers to better diagnose and treat cancer, heart disease, neurological diseases and other conditions earlier. Our vision for the future is to enable a new "early health" model of care focused on earlier diagnosis, pre-symptomatic disease detection and disease prevention. Headquartered in the UK, GE Healthcare is a $17 billion unit of General Electric Company. Worldwide, GE Healthcare employs more than 46,000 people committed to serving healthcare professionals and their patients in more than 100 countries. In India, the life sciences division of GE Healthcare is headquartered in Chennai with offices in all major cities and employs 45 specialized staff in sales, service and application support. Recently, a life sciences research and training laboratory was set up in Bangalore. GE Healthcare supplies chromatography media and equipment for all commonly used separation techniques. These include Capto - for high productivity capture; MabSelect for purification of monoclonal antibodies; Sepharose Fast Flow- for all general purpose separations; Columns - from prepacked, lab-scale; HiTrap columns, to production-scale Chromaflow columns; Ã„KTAdesign systems - from lab bench to production hall; and UNICORN software â€“ for control of all systems. In membrane separations, GE Healthcare provides Hollow fiber cartridges and Kvick cassettes; Ã„KTAcrossflow - the first fully automated pilot-scale system for development, optimization and scale-up; and UniFlux large-scale systems. The company supplies the latest technology equipment, reagents and kits for proteomics, cellular and genomics work. These include InCell: cellular and subcellular imaging system; Typhoon: variable mode multi color imagers; CyDye DIGE Fluors: patented DIGE technology in protein analysis; Biacore: label free protein interaction analysis; and Illustra: range of nucleic acid purification kits. GE Healthcare is all set launch a new India-specific, India-made 1.5-kg portable ECG, MAC 400, targeted at physicians and rural practitioners. Two more diagnostic imaging products would be introduced this year. The company now sources nearly 15 percent of its products from India, compared to half of this five years back. It has invested more than $100 million in India. ]]> <![CDATA[Money Spinner]]> https://biospectrumindia.com/news/95/5612/money-spinner.html https://biospectrumindia.com/news/95/5612/money-spinner.html Sat, 07 Jul 2007 14:42:00 +0530 New Page 1 Money Spinner Shimadzu Analytical (India) has close to 30 percent market share in the Rs 500-crore analytical and scientific instrumentation market in India. It is looking at achieving revenues to the tune of Rs 300-400 crore in the next five years. CEO: Tsuguo Kishida (MD) Revenue: Rs 110 crore Start-up Year: 2006 Address: 1 A/B, Rushabh Chambers, Makawana Road, Marol, Andheri (E), Mumbai -400 059 Tel.: 91-22 -29204741 Fax: 91-22-29201678 Website: http://www.shimadzu.com Shimadzu Analytical (India), a wholly owned subsidiary of Shimadzu Corporation, Japan has been offering technologies in the field of analytical and scientific instrumentation, and process control instrumentation, environmental monitoring to different industries including life sciences and biotechnology. Its total sales turnover for the year 2006-07 stood at Rs 166 crore against last year's total sales turnover of Rs 150 crore. Its sales turnover from the life science/biotech sector for the year 2006-07 stood at Rs 110 crore against last year's sales revenue of Rs 82 crore, registering a growth of 33 percent. It hopes to grow at an even better pace in the current year. Shimadzu has been in the Indian market for the last 40 years providing solutions through supply of high quality instruments in quality control and R&D laboratories all over India through its established network of distributors. Shimadzu has close to 30 percent market share in the analytical and scientific instrumentation market in India that is estimated to be about Rs 500 crore. It is looking at achieving a target of Rs 300-400 crore in the next five years. Headquartered in Mumbai, it has branch offices at New Delhi and Chennai. It has increased its staff strength to 35 employees from last year's strength of 20. It is expected to further increase it to 40 very soon. The company would strengthen its activities and support facilities at its customer support center (established in April 2006) in Mumbai and is in the midst of taking up the Delhi office expansion. The customer support center is established to serve the customers and industry better by means of demonstration, application support and training programs as well as training programs for its distribution network. For this it has invested about Rs 4 crore (100 million Yen). In addition to overseeing the activities of the customer support center, it also provides the marketing support to its distributors. Shimadzu's product offerings include mass spectrometry integrated with enabling technology for high throughput analysis (MALDI, LC/MS, automated systems for analyzing gels with mass spectrometry) and specific solutions for DNA analysis (ranging from UV spectroscopy to chip-based electrophoresis) among a range of other offerings. ]]> <![CDATA[Biotech Engineer]]> https://biospectrumindia.com/news/95/2026/biotech-engineer.html https://biospectrumindia.com/news/95/2026/biotech-engineer.html Sat, 07 Jul 2007 14:28:00 +0530 New Page 1 Biotech Engineer Sartorius India's core engineering competence is in design, production, installation, commissioning, automation, integration, validation of fermentors and peripheral systems. CEO: Amit Chatterjee (MD) Revenue: Rs 112.03 crore Start-up Year: 1991 Address: 10, 6th Main, 3rd Phase, Peenya, KIADB Industrial Area, Bangalore -560 058 Tel.: 91-80-28391963/0461 Fax: 91-80-2839 8262 Website: www.sartorius.com The Sartorius Group is a world-leading laboratory and process technology supplier covering the segments of biotechnology and mechatronics. Headquartered in the university town of Goettingen, Germany, Sartorius was founded in 1870. The company has the distinction of pioneering several developments and innovations, especially in laboratory weighing and separation technologies. Since 1996, Sartorius has not only expanded its operations globally spearheaded by seven group brands, but has also successfully positioned itself in three technologies of the 21st century â€“ biotechnology, mechatronics and environmental technology. The company's customers are in the US, Germany, Australia, China, Cuba, Hong Kong, Indonesia, Israel, Malaysia, Korea, New Zealand, Taiwan, Thailand, Italy and UAE. Sartorius India, the biotech subsidiary, plays a key role within Sartorius Group as one among four system manufacturing facilities for Sartorius worldwide (the other three are located in the US, Germany and Italy). Sartorius India's core engineering competence is in design, production, installation, commissioning, automation, integration, validation of fermentors and peripheral systems. In India, Sartorius operates eight branches in key metro cities addressing customer's process chain in the pharma, biotech, laboratories, and food and beverage industries. Sartorius India is planning to set up a dedicated campus in Bangalore at an investment of Rs 25 crore. The company intends to shift its entire operations from Peenya Industrial Area to its new location by Q3 in 2007. Among the investments in 2006-07, the company has set aside Rs one crore each for its SAP implementation network project and an application lab in the present premises. While the SAP application gets live next year, the lab which is a customer training center in cell culture and down stream purification technologies, will be commissioned in September this year. The mechatronics division of Sartorius India, Sartorius Mechatronics, encapsulates the consolidation of Sartorius technology and knowledge acquired from years of expertise from the other group companies such as Global Weighing and Boekels on one common platform. It enjoys the status of a global leader in weighing applications, precision, analytical weighing applications and industrial weighing with cutting edge technology in industrial loadcells, electronics, system engineering and process weighing solutions. ]]> <![CDATA[Purification Leader]]> https://biospectrumindia.com/news/95/1812/purification-leader.html https://biospectrumindia.com/news/95/1812/purification-leader.html Sat, 07 Jul 2007 14:20:00 +0530 New Page 1 Purification Leader Millipore's EOU produces sophisticated chromatography systems and columns for world markets as part of Millipore Corporation's global supply chain initiative and contributes to the company's growth. CEO: Sudhir Kant (President) Revenue: Rs 136.07 crore Start-up Year: 1988 Address: 50 A, II Stage, Peenya Industrial Area, Bangalore â€“ 560 068 Tel.: 91-80-28396320, 28394657 Fax: 91-80-28396345 Website: www.millipore.com Millipore India, an ISO 9001:2000 company with a turnover of over Rs 136 crore in FY 2006-07, offers Indian manufacturers of biopharmaceuticals the entire range of solutions from upstream to downstream processing of biologics- including cell/media supplements, advanced manufacturing solutions, process monitoring tools, filtration purification and chromatography solutions plus validation and process development services and training. These solutions come from the bioprocess division of the company. The bioscience division in addition to a range of water purification systems and solutions for general filtration, protein research, genomics and drug discovery, extends its range to include gold standard reagents, media, cell lines and antibodies from Chemicon, Upstate and Linco. These are very popular in the areas of cell biology, immunodetection and drug discovery. With this, Millipore India has entered new research areas in life sciences research in cardiovascular and infectious diseases, oncology, matrix biology, cytokines, neuroscience, metabolic disorders and signal transduction. These are supported by a group of PhDs at Millipore's technology support group. The lab water purification range continues to make more breakthroughs- both in market dominance and in new innovations. The Advantage Milli-Q A10 with Q-Pod was a new breakthrough in water delivery systems. Millipore remains the only company to offer qualification services for both large and small systems. The first bioprocess validation and process development facility in the country has established its extractables lab while completing the maximum number of filter validation studies in India. Millipore's predominant position in processing monoclonal antibodies with its unique expertise has been consolidated further. More than 400 pharma professionals have undergone training at Millipore's Filtration Schools. The manufacturing operations at Millipore's EOU produces sophisticated chromatography systems and columns for world markets as part of Millipore Corporation's global supply chain initiative and contributes to the company's growth. The most significant strategic step forward for the benefit of customers has been the spate of new acquisitions by Millipore Corporation. Serologicals- with its group companies Celliance, Chemicon, Upstate, Linco and NovAseptic, NovAseptum, Newport and Microsafe plus an alliance with Genprobe has transformed Millipore from a filtration and purification leader to a $1.5-billion science company with perhaps the widest offering of products, services, tools and technologies.     ]]> <![CDATA[Cultured Practices]]> https://biospectrumindia.com/news/95/4202/cultured-practices.html https://biospectrumindia.com/news/95/4202/cultured-practices.html Sat, 07 Jul 2007 14:16:00 +0530 New Page 1 Cultured Practices ISO 9000-certified HiMedia is rapidly emerging as a plant tissue culture, animal and insect cell culture, molecular biology and immunodiagnostics company. CEO: Dr GM Warke Revenue: Rs 150 crore Start-up Year: 1973 Address: A 406, Bhaveshwar Plaza, LBS Marg, Mumbai â€“ 400086 Tel.: 91-22-2500 3747/0970 Fax: 91-22-2500 5764 Website: www.himedialabs.com HiMedia Laboratories started as an import substitution company for bacteriological culture media in mid 1970s by a small team of researchers headed by Dr GM Warke. It has grown to such an extent that now it is a Rs 150-crore company (for the year 2006-07), marketing its products across the world. It registered a growth of 25 percent in 2006-07 over the previous year's sales turnover of Rs 120 crore. In 2004-05, its sales turnover stood at Rs 100 crore, registering a growth rate of 20 percent. Today HiMedia, an ISO 9000 company, is rapidly emerging as a plant tissue culture, animal and insect cell culture, molecular biology and immunodiagnostics company. HiMedia has been exporting its range of products over 2,000 in number in dehydrated culture media, bulk raw materials for fermentation, laboratory chemicals, antibiotic sensitivity products and laboratory consumables to over 80 countries and at the same time reaching the Indian customers through a network of 2000 distributors. It offers its range of products to customers in clinical, industrial, research and academic laboratories around the world. With state-of-the-art facilities and all necessary certification and accreditations in place, HiMedia today is leading global player in microbiological culture media. It has established its leadership as the only company with a complete range of 750 animal free media used in every industry. HiMedia Laboratories has launched a line of 14 vegetable based peptones matching the performances of all the traditional animal/bovine based peptones in North America through an alliance with VWR International, a pure play global distributor. The company has also ventured into genomics by launching rapid diagnostic kits. These kits facilitate the isolation and purification of DNA. It is a recipient of the Rajiv Gandhi National Quality Award for the year 2006 in the Small Scale Manufacturing Industry category given by the Ministry of Agriculture, Consumer Affairs, Food and Public Distribution. The award was given annually by the Bureau of Indian Standards, instituted in 1991 on the lines of Malcolm Baldrige National Quality Award in the US. ]]> <![CDATA[The Facilitator]]> https://biospectrumindia.com/news/95/1004/the-facilitator.html https://biospectrumindia.com/news/95/1004/the-facilitator.html Sat, 07 Jul 2007 14:12:00 +0530 New Page 1 The Facilitator In the last two decades, Spinco Biotech has enabled many pharmaceutical and R&D labs establish and operate world-class chromatography instrumentation. CEO: C Ravindranath (MD) Revenue: Rs 156.17 crore Start-up Year: 1981 Address: PB No. 6114, No. 4, Vaidyaram Street, T Nagar, Chennai - 600 017 Tel.: 91-44-2434 0174 Fax: 91-44-2434 0761 Website: www.spincotech.com Spinco Biotech has been a biosupplier to analytical and life science laboratories across India, with a network of 22 offices and 220 plus professionals. Started in 1981, Spinco Biotech celebrated its silver jubilee year in 2006. The company has to its credit over 6,500 Shimadzu HPLC installations. It has four Strategic Business Units (SBUs) focusing on chromatography, life sciences, general laboratory (freeze dryers) and chemistry products. The chromatography SBU exclusively represents global leaders in HPLC instrumentation including Shimadzu (HPLC/LCMS); Polymer Laboratories (ELSD); AntecLeyden (electrochemical detector/systems); IN/US (radio chromatography detectors); and Wyatt (MALLA detector). Shimadzu's flagship HPLC Prominence is a performance system, which captured 1000 installations in India within two years. The Prominence UFLC delivers ultra-fast capability with flexibility to use as regular HPLC. The LC2010HT high throughput integrated system with an installed base of over 1,500 systems is used by many QC and GLP laboratories. The life science SBU is the growth engine for Spinco. It is focused to offer comprehensive solutions to genomics, proteomics and drug discovery segments. Spinco's genomics range includes Affymetrix GeneChip systems/array/reagents, which is the Gold Standard Microarray technology for gene expression, genotyping and resequencing applications. The proteomics range includes Kratos Analytical MALDI TOF/TOF analyzers, Shimadzu Biotech RD LC/Xcise 3-in-1 gel processor/Accuspot/chemical inkjet printer ChIP/protein sequencer/DeNova Ultra HT 384 capillary DNA sequencer. Wyatt Technology Dynapro protein characterization instruments, AAPPTEC Peptide/Organic Synthesizers, Wako Pure reagents are also supplied under Spinco Biotech's Life Science program. The general laboratory SBU focuses on the entire SP Industries, USA, range of products including VirTis/FTS Lab/Pilot/Production freeze dryers, Hull cGMP Production Lyos, Hotpack Sterilizers/Glassware washers; Wilmad NMR tubes. The other products include Foss NIR Systems, Peak Scientific Gas Generators; Omni, USA Homogenizers; ACS, USA Animal Care Systems. The chemistry SBU promotes HPLC/GC columns from Phenomenex, USA and Chiral columns from Daicel, Japan. Columns and consumables/spares are delivered ex-stock in Indian Rupees through ISO 9001 certified Spincotech warehouse at Chennai. Spinchrom Life Sciences is the customs bonded warehouse facility of Spinco Biotech focusing on columns, consumables and reagent supplies. ]]> <![CDATA[Measurable Growth]]> https://biospectrumindia.com/news/95/1057/measurable-growth.html https://biospectrumindia.com/news/95/1057/measurable-growth.html Sat, 07 Jul 2007 14:12:00 +0530 New Page 1 Measurable Growth Agilent's life sciences revenue touched Rs 180 crore for FY06-07, up from Rs 104 crore in FY 05-06. The company's double-digit growth is mostly fuelled by the biotechnology industry. CEO: Sanjeev Dhar Revenue: Rs 180 crore Start-up Year: 1989 Address: Chandiwala Estate, Maa Anandmai Marg, Kalkaji, New Delhi-110019 Tel.: 91-11-51496607 Fax: 91-11-26826068 Website: www.agilent.com Agilent is the world's premier measurement company, providing core bio-analytical and electronic measurement solutions to the communications, electronics, life sciences and chemical analysis industries. The company's 19,000 employees serve customers in more than 110 countries. Agilent had net revenue of $5.0 billion globally in the fiscal year 2006 up from $1.5 billion in 2005. Agilent India focuses on the entire life sciences value chain with backward and forward integration. Agilent LSCA India recorded revenue of Rs 180 crore for FY06-07 up from Rs 104 crore in FY 05-06. The company's double digit growth is mostly fuelled by the biotechnology industry with the main contributors being the LCMS (HPLC & RRLC) and lab informatics product range. The company introduced the Agilent 7890A gas chromatograph (GC) platform that features a 5th generation electronic pneumatics control (EPC) and digital electronics that set a new benchmark for retention time precision, while contributing to the platform's superior reliability. It is the first GC to regulate pressure to 0.001 psi. for the industry's most consistent retention times. In addition to this, the company also launched the 5975C that performs full-scan and selected ion monitoring (SIM) analyses simultaneously, with software that automatically creates a SIM method from a scan method. The platform also permits the exchange of methods electronically across multiple, far-flung labs. Agilent also introduced a microarray-based assay for microRNA (miRNA) expression profiling, delivering new levels of sensitivity and specificity while incorporating simple protocols for labeling and detection. The assay allows for very small amounts of sample (100 ng of total RNA) making it well-suited for miRNA expression profiling in cancer tissues from formalin-fixed paraffin-embedded samples. Agilent also shipped the 1,000th Rapid Resolution Liquid Chromatography System (worldwide) in February 2007. Agilent announced the definitive agreement to acquire Stratagene on April 6, 2007. Stratagene is a worldwide leader in developing innovative products and technologies for the growing life science research market. Agilent believes the total addressable life science market to be $14 billion, with an estimated compounded annual growth rate of 7 to 9 percent over the next three years. The Stratagene acquisition is expected to strengthen Agilent's life science offerings in genomics and proteomics, particularly in academia and government where Stratagene products and market leadership are well recognized. ]]> <![CDATA[Analytic Mechanist]]> https://biospectrumindia.com/news/95/2241/analytic-mechanist.html https://biospectrumindia.com/news/95/2241/analytic-mechanist.html Sat, 07 Jul 2007 13:10:00 +0530 New Page 1 Analytic Mechanist Waters India offers a comprehensive range of analytical systems and nearly 70 percent of its revenue is derived from the life sciences market. CEO: KV Venugopalan (President) Revenue: Rs 213.20 crore Start-up Year: January 1988 Address: No. 36A, II Phase, Peenya Industrial Area, Bangalore - 560 058 Tel.: 91-80-28371900-04 Fax: 91 80 28392157 Website: www.waters.com Waters India is a 100 percent subsidiary of the US-based Waters Corporation. It started operation in 1988. In 1997, it became a subsidiary of Waters Corporation. Waters India offers a comprehensive range of analytical systems across four critical areas: instruments, column chemistries, software and support services. Nearly 70 percent of the company's revenue is derived from the life science market. The total Waters business in India in 2006 stood at Rs 213.20 crore. Waters India has achieved the distinction of best performing subsidiary of Waters Corporation in 2005. Its customers in India are major biotech, pharmaceutical companies, major testing centers. Key customers include Ranbaxy, DRL, Biocon and Cipla. Its products and services help the pharmaceutical companies analyze their products to develop new molecules, to determine physico-chemical properties, conduct clinical trials and meet quality requirements for release of manufactured product. Most major prescription drugs are analyzed on Waters instruments. With addition of informatics solutions range, Waters can provide comprehensive end-to-end solution for labs, from sample preparation, to data handling to report generations for submissions. Waters Corporation is a leader in liquid chromatography and mass spectrometry products world over and Waters India is a leader in this market in India. Globally, the year 2006 marked Waters Corporation's 48th year of analytical instrument industry innovation. While the company offers a broad array of technologies, it still maintains platform products in four key areas: instruments, chemistries, software, and services. Its best known brands are ACQUITY UPLC Systems, ACQUITY UPLC BEH, XBridge, Sunfire, Symmetry, Atlantis and XTerra columns for analytical- to preparative-scale chromatography; Oasis solid phase extraction (SPE) products; Alliance HPLC and HPLC/MS Systems; Empower, MassLynx, NuGenesis SDMS, eLab Notebook Software, the premier line of mass spectrometers, and Waters global services and support programs: AssetCARE asset management service, relocation services and Connections INSIGHT programs. Waters Corporation in association with Northeastern University, has opened a new lab for protein research within the renowned Barnett Institute of Chemical and Biological Analysis at the university. The new laboratory is dedicated to studying protein shapes and characteristics to provide pharmaceutical and biotechnology innovators with the tools necessary to develop new treatment options for some of the world's deadiest diseases, like AIDS and cancer. ]]> <![CDATA[Consolidated Efforts]]> https://biospectrumindia.com/news/95/6999/consolidated-efforts.html https://biospectrumindia.com/news/95/6999/consolidated-efforts.html Sat, 07 Jul 2007 13:01:00 +0530 New Page 1 Consolidated Efforts Thermo Electron LLS India has grown mainly because of its spate of acquisitions. The company hopes to further consolidate its position in the life sciences market in India. CEO: Dr G Ramakrishnan (MD) Revenue: Rs 246 crore Start-up Year: 1998 Address: 102, 104, Delphi 'C' Wing, Hiranandani Business Park, Powai, Mumbai - 400 076 Tel.: 91-22-67429494 Fax: 91-22-67429495 Website: www.thermo.com Thermo Electron Life and Laboratory Sciences (LLS) India, a wholly owned subsidiary of US-based Thermo Fisher Scientific, is a key supplier of advanced analytical technologies, scientific and laboratory equipments and laboratory consumables to help scientists and clinicians to discover new drugs, understand its genetic makeup and diagnose illnesses and diseases. The total sales turnover of Thermo Fisher Scientific in India for the year 2006 stood at Rs 246 crore ($60 million), registering a growth of 42.66 percent over the previous year. The figure includes sales from Kendro, Fischer Scientific and Thermo Electron in India. In 2005, Thermo Electron's sales revenue stood at $38.32 million (Rs 172.44 crore). It includes the sales from the life and lab sciences division and scientific instrumentation divisions. Its sales in 2004 stood at $20 million (about Rs 86.4 crore) as against previous year's sales of $15.76 million (about Rs 70.92 crore). Dr G Ramakrishnan, managing director, Thermo Electron LLS India, said, "The growth of the company was mainly because of the acquisition of different companies by Thermo Electron. Consolidation of the company is taking place in India and it will be over by the end of this year. At present we have about 195 personnel working for Thermo Electron across the country. Considering the opportunity and market potential, we hope to further consolidate our position in the life sciences market in India." Thermo Fisher Scientific provides analytical instruments, equipments, reagents, consumables, laboratory supplies, software and services for research, analysis, discovery and diagnostics. Its growing product portfolio includes innovative technologies for mass spectrometry, elemental analysis, molecular spectroscopy, sample preparation, informatics, fine and high purity chemistry production, cell culture, RNA interference analysis, immuno diagnostic testing as well as air and water quality monitoring and process control. Its customers include companies from pharmaceutical, biotechnology industry, research institutions, government agencies, universities, clinical research organizations, and environmental and industrial process control settings. Thermo Electron LLS India has a manufacturing unit at Navi Mumbai that produces a range of finnpipette for ELISA readers and washers both for home and export consumption. ]]> <![CDATA[Industry scouts for partners and innovation]]> https://biospectrumindia.com/news/95/1458/industry-scouts-for-partners-and-innovation.html https://biospectrumindia.com/news/95/1458/industry-scouts-for-partners-and-innovation.html Sat, 07 Jul 2007 12:17:00 +0530 New Page 1 Industry scouts for partners and innovation The seventh edition of India's premier biotech show, Bangalore BIO 2007 was held in Bangalore during June 7-9, 2007. This year's event with the theme "Think Big Think Innovation", the event this year scaled up and has attracted over 600 delegates from across 15 countries. The three-day event attracted over 81 national and 33 international speakers, 625 conference delegates, 30,000 visitors (12,000 business and 15,000 student and general interest group), 152 exhibitors, and from over 12 countries, according to Vidyashankar, secretary, Department of IT and BT, Government of Karnataka. Vidyashankar added, "The seventh edition of Bangalore BIO has indeed had a successful run. True to the theme of innovation and growth, the event created a platform to forge ahead on various issues of R&D, life sciences informatics, ethics in clinical trials to name a few and build partnerships. The venue of BIEC provided the ideal environment for B2B interaction, and the exhibition and conference being held at the same venue allowed the participants to be present at the both locations in a seamless manner. Bangalore Bio also had a focused Agri Biotech day. This year's discussion brought to the forefront critical agri-biotech issues such as food productivity for India." Unveiling of the special supplement on Bangalore's biotech cluster brought out by BioSpectrum. BioSpectrum published a special report on the UK Bioscience sector, which was released at the inaugural session of Bangalore BIO 2007. Union Finance Minister P Chidambaram inaugurated the event on June 7, 2007. The government is aware that the sector is grappling with the issue of "early stage funding" and this has been addressed to a large extent by amending the tax law, giving concessions to the VCs to encourage them to make high risk business investments. He promised to help the industry if it still continues to face funding challenges. His statement came in response to the suggestion made to this effect by the chairperson of the Vision Group of Biotechnology (Karnataka), Kiran Mazumdar Shaw, who said the biotech companies were facing funding problems in their early stages. He also took note of the concern expressed by the biotech entrepreneurs that venture capital was not flowing to biotech innovation projects. "The industry is in the throes of a positive change," stated Dr Kiran Mazumdar-Shaw, chairperson of the Vision Group on Biotechnology and CMD, Biocon Ltd. She delineated the findings of the fifth annual BioSpectrum-ABLE Survey of the biotech industry in India. The growth is being led by the biopharma segment, which makes up for the $1.4 billion in the total turnover. According to Dr Shaw, the challenge for India now lies in enabling companies to move from innovation to pre-clinical stage and getting VCs to back innovation, apart from developing specialized human resource. Dr Shaw proposed that an Indian Institute of Biotechnology modeled after the country's famed IITs be established. At the inaugural function, the Government of Karnataka in collaboration with the Deakin University of Australia announced an Indian Research Institute to help build high-end skill for the biotechnology sector. Chidambaram stressed the need for utilizing biotechnology as an effective tool for providing a boost to agricultural development. He said the Union government was concerned over the slow growth rate of agricultural sector, though the country's overall economy was growing at a rapid pace. Dr Shaw also made a case for Software Technology Parks of India (STPIs) model to be implemented in the biotech sector. She exhorted Chidambaram to look into the proposal. The highlight of the Bangalore BIO 2007 show was the Australian delegation from the State of Victoria. The delegation on its first visit to India explored the partnership possibilities with Indian companies in various therapeutic areas. Attending Bangalore BIO conference for the third time in succession, with a strong UK business delegation, Sir Michael Arthur, British High Commissioner in India, said, "We see big potential for the business and science partnership on biotechnology between India and Britain. For Indian biotech companies, the UK must be the No.1 destination in Europe. Over 50 percent of Europe's publicly listed bioscience companies are based in the UK. The UK provides an excellent business environment with low corporate taxes; flexible and skilled workforce; the strongest capital market in Europe. Britain has a strong business research culture-1 spin off business for every $27,000,000 of research funding, compared to 1 for $80,000,000 in America." Australia, India partners-in-biotech At the India's premier biotech show Bangalore BIO 2007, two "cricket-crazy" nations came together to partner in the arena of life sciences. Prof. David de Krester, Governor of the State of Victoria led the Australian delegation, on its first exploratory visit to Bangalore, the biotech hub of India. Dr KK Narayanan, president, ABLE; Dr SA Patil, director, IARI; Bandeppa Kashempur, minister for agriculture, Karnataka, at the inaugural session of the Agribiotech Day. Speaking at the inaugural, Prof. Krester elaborated on the opportunities that both countries can collaborate on. "There are opportunities in agriculture, biotech, healthcare and stem cell research," he said adding that a revolution in the biotech industry is in the making and this is the time to partner and forge ahead. The high-powered delegation from Australia also had AusBiotech CEO, Anna Lavelle and Dr Amanda Caples, spearheading the cause of biotech industry, in the capacity of Director-Biotechnology for the State of Victoria. In Australia, the State of Victoria is a leader in the biotech industry, with 140 of the country's biotech companies headquartered there. In fact, out of the total research grant given by the federal government in Australia 43 percent goes to Victoria. The State is also home to Australia's top two universities. Dr Kiran Mazumdar-Shaw, CMD, Biocon; Anna Lavelle, CEO, Aus Biotech, Dr Nezih Cereb, MD, Histogenetics, and Dr Bala S Manian, founding CEO, ReaMetrix, sharing their insights at the CEO Conclave. One of the highlights of the Bangalore BIO 2007 was the effort to address two critical issues staring the industry in the face - early stage venture funding and the right kind of talent pool. As a step ahead, Biocon and Deakin University from the State of Victoria, signed an MoU for joint multi-disciplinary research focused on biotechnology and biosciences. Under the MoU, Deakin Research Institute will be established in Bangalore. Deakin University and Biocon will also work together for the development of $50 million the mammalian cell bio-processing facility at Geelong in Victoria. Deakin will also undertake research on metabolic diseases at its facility, on behalf of Biocon. Alexandria to build Bangalore Biotech Park Alexandria Real Estate Equities, based in Pasadena, California, will build the second and third phases of Bangalore's upcoming Biotech Park at a cost of approximately $140 million to cover 7,50,000 sft of lab space for life science and biotech companies. The long-delayed phase 1 of the Bangalore Helix, in the state of Karnataka being built by India-based National Building Construction Corporation (NBCC) with technical support from Singapore's JTC Corp, is likely to be completed in July 2007. Karnataka's IT and BT secretary, MN Vidyashankar said Alexandria was chosen from a list of 32 global bidders who offered take up the expansion work of Bangalore Helix. The memorandum of understanding (MoU) between the Karnataka government and Alexandria was signed on the inaugural day of the Bangalore Bio 2007. Alexandria is one of North America's leading builder and operator to life science park and this NYSE-listed company manages nearly 150 such parks covering 11 million sft of built up facilities such as the Technology Square at MIT in Cambridge, Massachusetts. Alexandria ventured out of the US for the first time in May 2007 when it was chosen to develop the re-branded Edinburgh BioQuarter, in Scotland. Bangalore Helix will be the second project being taken by Alexandria. The company is now developing nearly 6 million sft of life science parks including Mission Bay in San Francisco, and East River Science Park in New York. Vidyashankar and Karnataka's Biotech Vision Group Chairperson, Kiran Mazumdar-Shaw said the expansion of the Bangalore Helix will be based on public-private partnership model. When completed in 2009, Bangalore Helix will have an array facilities required by biotech companies, including wet labs, green house, animal house, incubators and other specialty infrastructure. The first phase of Bangalore Helix is likely to be opened in early July 2007 and two Bangalore-based institutions, the Institute of Bioinformatics and Applied Biology (IBAB) and Center for Human Genetics will move into it. The facility for these two institutions has been built at a cost of nearly $ 2.4 million. Several country partnership initiatives took place between Indian companies and research institutes through a series of meetings with delegations from the UK, France, Holland, Germany, US and Australia. The event saw active participation from 12 countries. Bangalore-based Avesthagen announced the signing of a pact with the Government of Andhra Pradesh, India for an additional 50 acres of land in the State's Biotech Park. The company is planning to set-up two manufacturing units in Hyderabad - Avestha Biotherapeutics & Research, which will manufacture biosimilar products and Avestha Good Earth, which will manufacture bionutraceuticals. Agri-Biotech Day at Bangalore BIO 2007 A day was dedicated to exclusively focus on agribiotech during Bangalore Bio. Bandeppa Kashempur, minister for agriculture, Government of Karnataka, who was chief guest, said, "We are taking ample measures to propose changes in the agricultural policy. We have a vision of achieving 4.5 percent growth with the available land in spite of increasing land conversion for industrial and residential purposes." He noted that Karnataka has scientific resources to boost the agricultural sector. Underlining the need to increase productivity, he invited entrepreneurs and scientists to join the taskforce. Highlights of Bangalore BIO 2007 Several country partnerships were initiated through a series of meetings with delegations from Australia, France, Germany, Holland, the UK, and the US. Avesthagen signed a pact with the Andhra Pradesh government for an additional 50 acres of land in the state's Biotech park. The company is planning two manufacturing units in Hyderabad. One is Avestha Biotherapeutics & Research to manufacture bio similar products. The other is Avestha Good Earth, which will manufacture bionutraceuticals. Biocon signed a MoU with Deakin University, Victoria, Australia, for joint multi-disciplinary research focused on biotechnology and biosciences. Deakin University announced that it would set up Deakin Research Institute in Bangalore. One of the highlights of this year's event was the Poster Session, where over 35 papers were presented by young scientists and innovators. Biotalent zone hosted career interactive session in an innovative way. Elaborating on the need for private-public partnerships to boost agri-biotechnology sector, Dr SA Patil, director, Indian Agricultural Research Institute, New Delhi, stated, "Partnership mode of private and public sectors will give miraculous results. The need of the hour is to set up a fund by Karnataka to promote agribiotech. Highlighting the challenges of the agriculture industry, Dr KK Narayanan, president, ABLE and managing director, Metahelix Life Sciences, stated, "India has a large extent of agricultural land (100 million hector) which is second only to the US. Though India is the largest producer of rice with 44 million hectares of land, productivity levels are low." He pointed out the IT services sector showed a growth rate of 13 percent, manufacturing 12 percent, while the agriculture grew only by 2 percent. Though 2/3rd of the population is engaged in farming, only one-fourth contribute to the GDP, which amounts to less than one-fifth of the total GDP. He appealed for a sustainable model for growth in this sector. Bangalore BIO 2008 will be held on 24 -26, April 2008 Bangalore BIO 2009 will be held on 15 -17, April 2009 Bangalore BIO 2010 will be held on 02 -04, June 2010   Ch. Srinivas Rao ]]> <![CDATA[ES Cell offers hES tech to ReproCELL]]> https://biospectrumindia.com/news/95/1397/es-cell-offers-hes-tech-to-reprocell.html https://biospectrumindia.com/news/95/1397/es-cell-offers-hes-tech-to-reprocell.html Sat, 07 Jul 2007 12:12:00 +0530 New Page 1 ES Cell offers hES tech to ReproCELL ES Cell International, the Singapore-based stem cell company, has agreed to transfer its key stem cell technology to Tokyo-based ReproCELL, a Kyoton and Tokyo University spin out company, to kick start some exciting practical uses in drug discovery testing and research efforts. Smart pills, virus chips on the way Smart pills that know exactly to which part of the human body it should go to deliver the right amount of medicine, a virus chip that carries the information about every virus that exists in the world, a method to diagnose cancer using just blood samples, and manufacturing with microbes are among the latest things under advance stages of development in some of the world's best biotech laboratories. "The smart pill can contain up to three drugs and will be able to deliver them to the right part," said Dr Regis Telly, director, QB3 and professor at University of California San Francisco (UCSF), while talking about industry-academia collaborations during the 6th Bio Forum and Bio Expo in Tokyo. The smart pill and other such major scientific breakthroughs are going on in three University of California campuses at Berkeley, San Francisco and Southern California. These three universities have come together to pool their resources under a government program to integrate all their technological resources with over $150 million in research grants. Other major research centers in the region such as California Institute for Quantitative Biomedical Research, California Nanosystems Institute and Institute for Telecommunications and Information Technology, etc., are all part of the innovative program. "California government decided that it won't put its money into private companies but spend it in university labs to develop cutting edge technological tools," said Dr Kelly. The efforts have been worth it considering the wide range of futuristic products and services under development with additional investments totaling just $200 million. The two companies signed an agreement to this effect during the 6th International BioForum and BioExpo Japan. ES Cell, started in Singapore by Dr Alan Colman, one of the co-developer of the world's first cloned sheep, Dolly, will transfer its techniques to make cardiac muscle cell prepared from embryonic stem cells. Dr Colman's company is currently developing a cardiac muscle, called, cardiomyocytes, made from human embryonic stem cells (hES). "The technology transfer will enable ReproCELL to use the technique in practical applications and lower the cost of pharma R&D and speed up the drug development process," said a Dr Norio Nakatsuji, a key scientist behind ReproCELL and professor at the Institute for Frontier Medical Sciences, Kyoto University, Kyoto, Japan. Dr Colman told BioSpectrum, that his company, set up with majority venture funding from Singapore government's investment companies six years ago, was concentrating on developing the cardiac muscle and hence offered the technique for other practical applications. This would also open a new revenue stream for ES Cell. ReproCELL will use the cardio muscle technology to develop models to conduct safety and toxicity studies for various pharmaceutical products under development. The Japanese company has successfully developed stem cell lines from rhesus monkey, which have the same blood group as humans. The Japanese company, set up by Kyoto and Tokyo University researchers, has been actively looking out for business and technology partners in the Asian region. While the regenerative treatment methods under development at stem cell research companies will take many more years to demonstrate their efficacy, the drug testing models will offer new revenue opportunities for such start up in the biotechnology sector. Dr Colman said his company was trying to speed up the development process of its cell therapy technique and it may be able to do its first clinical trials on human volunteers only in 2009.   Narayanan Suresh recently in Tokyo   ]]> <![CDATA[Japan facilitates VC inflow in life sciences]]> https://biospectrumindia.com/news/95/2762/japan-facilitates-vc-inflow-in-life-sciences.html https://biospectrumindia.com/news/95/2762/japan-facilitates-vc-inflow-in-life-sciences.html Sat, 07 Jul 2007 12:09:00 +0530 New Page 1 Japan facilitates VC inflow in life sciences The Japan government's strategic decision to promote- innovative companies in the knowledge sector, including biotechnology, in a special three-year program has succeeded handsomely. Over 1,500 companies were spun out of academic institutions between 2003 and 2006, according to Japan's leading VC investor, JAFCO. "The government set a spinout target of 1,000 companies in two years when the program started in 2003. We achieved the target in the first two years itself, and by 2006 we had over 1,500 spinouts. Nearly 38 percent of these are in biotechnology and related areas," said Nobuo Fukudo, Director of JAFCO's Life Science Investment unit. The number of biotech companies is growing in Japan, and a lot of entrepreneurs have come into this field. Moreover, the pharma industry has also got into the act and the key players are making strategic investments and buying up failed-startups that have good technology development platforms and promising product lines, which could be revived, Fukudo said. "There are some 1.5 million companies in all sectors in Japan and VCs have channelized seven percent of their funds into the life sciences sector," said the industry's leading VC investor. Of course, JAFCO is looking at the Asian market itself and is keen to identify promising small and medium enterprises in this field in the region. He estimates that VCs have invested $50-100 million in drug discovery companies so far. Fukudo said like his counterparts everywhere, JAFCO looks at promising companies for investments at a very early stage and looks for an exit route within three-four years. JAFCO exits when the company goes public and six of the 11 companies in which it invested have gone public in the last three years. They look for a return of around 40 percent in three-four years of investment time. Most of the companies that were floated recently have an average market cap of $270 million, he pointed out. In the last 10 years, nearly 42 percent of the startup companies across various sectors in Japan have gone public. The share of life sciences was only three percent, Fukudo said. Japan's stock exchange for knowledge industry, JASDAQ is planning to set up a separate market for life science companies, on the lines of the Mother's Stocks on the Tokyo Stock Exchange. Keeping in mind the high level of initial investment, the new JASDAQ market will allow life science companies with minimal revenues to list on it. "The only criteria will be that the company should be making some revenues. Any revenue will be acceptable," Fukudo said. He advised the new wave of Japanese investors in the life sciences sector to shed their conservative approach towards intellectual property rights (IPR). The companies are really closed and do not disclose the potential of their IPR for fear of being misused. This was leading to very low market cap for the companies. "The companies should be more open, have more linkages with the rest of the world and look at the regional and global markets more aggressively," Fukudo advised. Too much emphasis on NDAs (non disclosure agreements) is slowing down the sector, he said.   ]]> <![CDATA[Japan Rising]]> https://biospectrumindia.com/news/95/1085/japan-rising.html https://biospectrumindia.com/news/95/1085/japan-rising.html Sat, 07 Jul 2007 11:58:00 +0530 New Page 1 Japan Rising BioSpectrum captures the undercurrent of changes that are running through the Japanese life sciences industry. A special report from Bio Expo held at the Tokyo Big Sight. Electronic giant, Sony, digital camera leader Canon and automobile giant, Toyota - Japan has some of the world's best-recognized brand names, known for their reliability and quality. And these giants hold their own against the US, and Europe-based competitors. In the life sciences sector, Japan has the world's second largest pharma, biotech and medical instruments market. But its largest pharma company, Takeda Pharmaceuticals ranks only 15th in the global list of pharma giants and is not very well known outside the country. This is something that has been agitating the country's policy makers and business leaders alike for sometime. The government has opened up the sector with a slew of regulatory reforms, attractive incentives to venture capitalists to invest in life science companies and selling its success story to the world in every possible way. These efforts seem to be paying off. The 6th International Bio Forum and BioJapan in Tokyo from June 20-22, 2007 held at the Tokyo Big Sight in the sprawling eastern part of the capital city was an attempt to showcase the best of Japan in life sciences. Organized by Reeds Exhibitions Japan, the show combined the InterPhex, API and Pharma Machinery Expo together. The BioJapan show stole the thunder with an array of international speakers for the conference and over 650 exhibitors. With nearly 20,000 visitors from the biotech community participating in the event, BioJapan has certainly emerged as the largest event in the industry in the Asia Pacific region. Almost every speaker in the special conference sessions spoke about the need to raise the profile of the country's biotech industry. It doesn't pay to be insular. Go to the world, just like their counterparts from the other industrial sectors have, was the underlying theme of the event. The industry itself was made up of a few big players till a decade. A systematic approach has now led to the unleashing of the entrepreneurial energy in the country. Japan is also loosening its stringent regulatory systems to facilitate introduction of tried and tested products from abroad with minimum hassles.   ]]> <![CDATA[The political saga of GM crops in India]]> https://biospectrumindia.com/news/95/2901/the-political-saga-of-gm-crops-in-india.html https://biospectrumindia.com/news/95/2901/the-political-saga-of-gm-crops-in-india.html Sat, 07 Jul 2007 11:53:00 +0530 New Page 1 The political saga of GM crops in India Biotech experts Dr Shanthu Shantharam and Dr CS Prakash share their take on the trials and tribulations of Bt cotton in India. This year the fifth anniversary of Bt cotton commercializa- tion in India, and a look back at the road it has traversed; it can be best described as a success with serious public relations deficit. If one were to believe all the ghastly stories of how Bt cotton has brought doom to the lives of poor farmers in India, then one might as well blame all natural disasters in India on this "dreadful" Bt cotton. Certainly, the anti-GM lobby in India does everything possible, on a daily basis to discredit and disparage agricultural biotechnology, and get lots of traction in the media that does not care to verify facts. In fact, a journalist of a major daily said that "facts" are not news, sensation is. So far, the hapless Bt cotton has been dubbed genocidal and even homicidal. Going by the anti-GM lobby reports, it has killed sheep and goats in thousands, peacocks and cattle in hundreds. Next, it will be the turn of children who labor in the hybrid cotton seed production fields. Bt cotton is supposed to have made women sterile and made young girls attain early puberty; no news about what happened with boys so far. There are sporadic reports of Bt cotton field workers having developed allergic reactions. Thank heavens, no news of blood poisoning so far! A rooky farmer leader was brazen to declare that biotechnology is dangerous than nuclear technology, obviously betraying ignorance of both. Unwarranted allegations There has been an unfortunate spate of farmer suicides in the country in the last three to four years. Everybody has an opinion on why farmers are committing suicide, and so does the anti-GM lobby. According to them, Bt cotton is singularly responsible for suicides among cotton farmers in Vidharbha and Warangal. Ask for evidence, there is none. It is all based on God knows what kind of surveys, opinions and ad-hoc conclusions. The media laps it up merrily and never bothers to verify facts. The government agencies also don't care. But, for the first time ICAR has put out an official report on the performance of Bt cotton, which is on a positive note. No doubt, the anti-GM lobby will not buy this. Good news about Bt cotton is bad news for the anti-GM lobby. If the same ICAR scientists allude anything even remotely negative about Bt cotton, then it is taken as authentic, but if the same ICAR says anything positive about biotechnology or GM crops, then it not kosher for the anti-biotech forces. It is really impossible to verify all these claims and counter claims. The proof pudding is in eating. This year, India has surpassed China is Bt cotton acreage. Does this satisfy the anti-lobby? When one of us visited Warangal last November, there was no evidence of Bt cotton failure. We could not locate a single shepherd whose sheep had died and no farmer had heard of it. We could confirm from the State Department of Agriculture officials that 90-95 percent of cotton grown in Warangal is Bt cotton that was confirmed by educated farmers and pesticide dealers in town. Yet, the anti-GM lobby does not accept these facts, and continues to spread lies and canards about everything imaginary about Bt cotton. Politicized issue The big question is why do all NGOs (we know of only one NGO that supports modern biotechnology and science) are 'such die-hard' opponents of biotechnology and GM crops that is based on some of the best science in the world. The politicization of GM crops technology was complete when Pattali Makkal Katchi (PMK), a partner in the ruling coalition in Tamil Nadu and the former lady chief minister of the same state have taken a stand against GM crops at the goading of the anti-GM lobby. Otherwise, it is hard to believe that these politicians would have any idea about these modern day cutting edge technologies. This is just the beginning, and should the anti-GM lobby persist in their efforts, they can get more converts among the political parties whose understanding of science and technology is worse than that of NGOs. A ham handed intervention by the agricultural minister of Andhra Pradesh to slash the price of Bt cotton by more than 50 percent, only to be followed by other states smacks of rank political populism to garner farmers votes. This is another brazen political intervention by the political mighty. In this instance, the role of NGOs in misleading the agriculture minister must not be understated. The state government reports on the failures of Bt cotton are bereft of any scientific or empirical evidence, and appear pitiable. Lopsided views All these oppositions from the NGO community are coming from ideological opposition to globalization, multi-national corporations, and free market capitalism, all sentiments liberally borrowed from the European greens and socialists. The idea of "re-ruralization" of India by taking back Indian farmers to old fashioned, pre-independence agriculture is a clear indication of technical bankruptcy of what these NGOs would like to accomplish, if they had their way. That is to keep poor Indian farmers poor by adhering to the backward and non-productive agricultural systems. The anti-GM lobby draws lots of inspiration and resources from the European greens, the organic lobby, and anti-globalization lobbies (world social forum) to sustain their activities. Another constant refrain one hears is that Indian GM crops policies are being implemented without proper stakeholder or public consultations. Not withstanding hundreds of consultations that have been held, the NGOs are not happy because these consultations have not resulted in banning the GM technology. No amount of public consultations will satisfy these NGOs until they get their wish. The latest series of activism against GM crops is unraveling at the grassroots level where the anti-GM NGOs are going from village to village swearing villages to declare themselves GMO-free villages. No one knows what will come out of this GMO-free village campaign, but is an indication how motivated these forces are. Regarding GM food safety, some NGOs wish that they be tested for next 50 years until they can prove to be safe beyond reasonable doubt. This way, they know that they can tie up the product forever and nothing will come to the market place. All these kinds of scientifically unreasonable demands by NGOs are a clear indication of what they want, and that is to see that the technology is killed in its infancy. Clearly an anti-biotech political agenda. Who will bell the cat? What is regrettable is the deafening silence of the great Indian scientific community. Even a scientist headed committee to reform the Indian regulatory system has recommended that GM rice must not be introduced into areas that are known to be centers of origin and diversity, a patently nonsensical idea. This was done just to appease the anti-GM lobby. The quarantining of areas will never work and GM rice will find its way to every nook and corner of the country. The point here is that since such a deployment strategy will not work, then push for total ban on GM rice, and the war cry has already started. There are four academies of sciences in India, and scores of individual science associations, but none dares to take on this anti-GM lobby to inform the public or the media. These academies could have submitted an amicus curiae brief against the case in the Supreme Court of India filed by half a dozen anti-GM activists. But, these academies have gone on AWOL (Absent WithOut Leave) on the issue. The science establishment is totally apathetic about this raging anti-biotech and anti-GM controversy, the anti's have a field day, and the media has nowhere to go to verify facts. This is a political battle, and must be fought at the political level by the combined activism of scientists and technologists. Otherwise, not only the technology deployment will be delayed, but many future products that are in the pipeline may never see the light of the day. Indian agriculture badly needs all the modern technology to upgrade itself and compete at the global level, and these ideological opponents must not be allowed to hijack the agriculture development of the country, and dictate terms to the nation. Opportunity costs are too high of not deploying modern science and technology for India's agricultural development.   ]]> <![CDATA[BioIndustrial sector touches Rs 395 cr, registers 5.33% growth]]> https://biospectrumindia.com/news/95/2059/bioindustrial-sector-touches-rs-395-cr-registers-5-33-growth.html https://biospectrumindia.com/news/95/2059/bioindustrial-sector-touches-rs-395-cr-registers-5-33-growth.html Sat, 07 Jul 2007 11:50:00 +0530 New Page 1 BioIndustrial sector touches Rs 395 cr, registers 5.33% growth The BioIndustrial sector is estimated to have touched Rs 395 crore with a growth rate of just 5.33 percent for the year 2006-07 as against the previous year's growth rate of 17 percent. Though the growth rate is negligible, it has been good in terms of volume. The applications of industrial enzymes have been on the rise in India since various industries have been using enzymes. Revenues from the top five companies accounted for 87 percent of the total market size while the rest of the companies contributed the remaining. Novozymes and Biocon continued to dominate the industrial enzymes market in India with contributions close to 50 percent of the total enzymes revenues. Novozymes is leading the Indian enzymes sector with Rs 100 crore (2006-07) followed by Biocon. The other leading companies in this sector include Advanced Enzymes Technologies, Rossari Biotech, Zytex, Maps India, Lumis Biotech and Textan Chemicals. Novozymes, Advanced Enzymes Technologies and Zytex have registered over 20 percent growth in 2006-07 against the previous year. Rossari registered over 60 percent growth while Biocon registered 12 percent growth over the previous year's sales revenue. Considering the huge market potential in India, Novozymes is setting up a new laboratory in Bangalore, thereby establishing R&D operations in India for the first time. The new facility will initially focus on optimizing enzyme properties. It is expected to be fully operational from mid 2008. Similarly Advanced Enzymes Technologies has taken many initiatives, the most crucial one being setting up a manufacturing facility at Indore at an investment of Rs 15 crore. The company has set aside another Rs 35 crore for its expansion. To create awareness about the benefits of enzymes in different industries, Advanced Enzymes has been participating in seminars and conferences, both in India and abroad. It also has been organizing conferences at different places. This will help in increasing the market potential for enzymes in the country. There are about 15 companies involved in enzymes business with few into manufacturing. The rest are into the marketing business. Although the sector has been on a growth trajectory with no regulatory issues, it is yet to grab the attention of entrepreneurs. The sector has not seen any new companies during the year. This is because of high initial cost involved in setting up the facility and also lack of skilled people with technical know-how. Only a handful of companies like Biocon, Advanced Enzymes, Lumis Biotech, Maps India, Textan Chemicals, Rossari Biotech, Fermenta Biotech and Concord Biotech have established manufacturing facilities in India. Biocon, the first enzyme company globally received the ISO 9001 accreditation. The rest are involved in formulation and trading activities. Indian companies are manufacturing microbial enzymes but still looking at importing glandular enzymes. The companies have been importing enzymes from the US, Canada and China. The companies are now looking at newer areas like food processing, agriculture, animal nutrition, dairy, aquaculture and marine besides the conventional areas such as pharmaceuticals, textiles, breweries, chemicals and tannery. A few other companies like Biocon, Advanced Enzymes, Rossari and Lumis are involved in exporting enzymes to various countries. The government of India has also been considerate to the sector, as it has been funding projects related to industrial enzymes. This will help the industry grow, launch new products and compete with global players.   ]]> <![CDATA[BioInformatics records Rs 145 crore]]> https://biospectrumindia.com/news/95/2303/bioinformatics-records-rs-145-crore.html https://biospectrumindia.com/news/95/2303/bioinformatics-records-rs-145-crore.html Sat, 07 Jul 2007 11:47:00 +0530 New Page 1 BioInformatics records Rs 145 crore The Bioinformatics sector in India is estimated to have grown to Rs 145 crore in 2006-07 as against the previous year's figure of Rs 120 crore. Though the figure may not be big, the industry in 2006-07 witnessed many activities in terms of launching new tools, opening an overseas subsidiary, acquisitions, getting funds from financial institutions. Strand Life Sciences announced the launch of its SAR modelling and deployment platform - Sarchitect. Gilead Sciences has signed on as the first customer of Sarchitect. In addition to launching the platform tool, Strand Life Sciences entered into collaboration with Pharmidex, a key global player in assessing the ability of compounds to cross the blood-brain barrier (BBB). With this, now both companies focus on providing solutions to facilitate the discovery and development of new medicines. It has also integrated ChemAxon's JChem suite of software with admetis, its tool for modeling and predicting drug-relevant properties of molecules in silico. The integrated offering was launched in early 2006. The developmental toxicology laboratory of Dr Dhawan of the Industrial Toxicology Research Center (ITRC) at Lucknow has selected VLifeMDS software developed by Pune-based VLife Sciences as its mainstream software for their computational research. Switzerland-based PharmaBase too entered into a strategic initiative in the pharmaceutical space with VLife to develop new candidates for anti-arthritic application. The good news for the bioinformatics sector was positive initiatives taken up by the financial institutes during the year. Kotak Mahindra Bank, one of the premier private banks in India announced investments in VLife subscribing singularly to the entire series A round of funding solicited by VLife. Ocimum Biosolutions announced that International Finance Corporation (IFC), the private sector arm of the World Bank Group, will invest $6.5 million of equity, for a minority stake, and debt in the company. Ocimum said the funds raised from this transaction would be used for financing both organic as well as inorganic growth of the company. Strand Life Sciences and Ocimum Biosolutions have announced that they have joined the BioIT Alliance formed by Microsoft. The alliance is a cross-industry group working to further integrate science and technology as a first step towards making personalized medicine a reality. This alliance will help the companies to address the growing need for intelligent informatics solutions in the global life-sciences sector. Formed in 2006, the BioIT Alliance is a cross-industry group working together to improve biomedical information technology on the Microsoft platform. Founding members include Affymetrix, Accelrys Software, Amylin Pharmaceuticals, Applied Biosystems, The BioTeam, Digipede Technologies LLC, Discovery Biosciences Corporation, Geospiza, Hewlett-Packard Development Company, LP, InterKnowlogy, Microsoft Corporation, Sun Microsystems, VizX Labs LLC and other key companies in the pharmaceutical, biotech, hardware and software industries. Meanwhile, Ocimum Biosolutions has acquired the biomolecules synthesis business of Isogen Life Science based in The Netherlands. And it has also set up its German subsidiary in Ebersberg in order to expand its presence in the European market. This is a key milestone for Ocimum after its successful acquisition of the Microarrays division of MWG Biotech AG. The German subsidiary, Ocimum Germany GmbH, aims to tap the huge genomics market in Europe and provide quality R&D enabling solutions to universities, research institutes, biotech and pharma companies in Europe. During the year, Tata Consultancy Services (TCS) has won a multi-million dollar contract spread over 12-months from the US-based life sciences firm Sequenom to develop software solutions. The software solutions will provide a framework of validated components that will allow Sequenom to rapidly develop and deploy software products to empower its clients. The genomics module from the Bio-Suite software suite, developed by TCS, is also being licensed to the firm on a non-exclusive basis. Life sciences and healthcare contribute 4 percent to TCS' revenues. So 2006-07 was a happening year for the bioinformatics sector. Though the sector could not register much growth in terms of revenue, activities like funding, launching new products and tools, setting up of subsidiary during the year will definitely help the companies to increase the revenue in the coming years. Government initiatives and government supported R&D activities have given a boost to the sector, which is expected to see more activities in the coming months. ]]> <![CDATA[Rasi, Nuziveedu push BioAgri sales]]> https://biospectrumindia.com/news/95/2943/rasi-nuziveedu-push-bioagri-sales.html https://biospectrumindia.com/news/95/2943/rasi-nuziveedu-push-bioagri-sales.html Sat, 07 Jul 2007 11:38:00 +0530 New Page 1 Rasi, Nuziveedu push BioAgri sales BioAgri sector records Rs 926 crore in sales, registers 54.85% growth The BioAgri sector, primarily driven by Bt cotton, was the third largest contributor to the total biotech business of Rs 8,541 crore, accounting for 10.84 percent share of the pie. The sector grew by 54 .85 percent. Rasi Seeds, Nuziveedu Seeds and Mahyco have been the prime contributors to this sector with revenues of Rs 333.33 crore, Rs 226.42 crore, and Rs 110.69 crore respectively. These three accounted for 72.34 percent share of the total BioAgri market. The Bt cotton seeds market alone is estimated at Rs 835 crore. During the year, India overtook China in terms of total area under Bt cotton cultivation. This is a significant achievement considering the fact that Bt cotton was introduced for commercial cultivation in the country in 2002. According to The International Service for the Acquisition of Agri-biotech Applications (ISAAA), the area under Bt cotton tripled to 3.8 million hectares. India surpassed China, which had 3.5 million hectares of Bt cotton under cultivation. A total of 62 Bt cotton hybrids were approved for planting in 2006 compared with 20 in 2005 and four in 2004. The major states growing Bt cotton in 2006, listed in order of hectarage, are Maharashtra (1,840 million hectares representing almost half, 48 percent of all Bt cotton in India in 2006) followed by Andhra Pradesh (8,30,000 hectares or 22 percent), Gujarat (4,70,000 hectares or 12 percent), Madhya Pradesh (3,10,000 hectares or 8 percent), and 2,15,000 hectares (6 percent) in the northern zone and the remainder in Karnataka and Tamil Nadu and other states. In 2006, three new events were approved for incorporation, taking the total events to four. The first event known as Bollgard-I (BG-1), featuring the cry1Ac gene was developed by Maharashtra Hybrid Seed Company (Mahyco), sourced from Monsanto, and approved for sale for the sixth consecutive year in a total of 48 hybrids for use in the different regions (north, central and south) in the country. The second event, Bollgard-II (BG-II with event MON 15985) also developed by Mahyco and sourced by Monsanto, which featured the stacked genes cry1Ac and cry2Ab, was approved for sale for the first time in a total of seven hybrids for use in the central and south regions. The third event, known as Event 1 was developed by JK Seeds featuring the cry1 Ac gene, sourced from IIT Kharagpur, India and approved for sale for the first time in a total of four hybrids for use in the north, central and south regions. The fourth and the last event, the GFM event, was developed by Nath Seeds, sourced from China, featured the fused genes cry1Ab and cry1Ac and approved for sale for the first time in a total of three hybrids, one in each of the three regions of the country. By May 2007, 111 Bt cotton hybrids have been approved for commercial cultivation. Out of these 83 hybrids are based on Bollgard-I, 15 on Bollgard-II, six on Event-I, and six on GFM Event. Though hybrids based on the existing events are being given clearances by the Genetic Engineering Approval Committee (GEAC), it has blocked large scale trials (LST) of new events. Metahelix had sought LST and seed production approval for three Bt cotton hybrids (5174, 3134 and 5125) incorporating its own in-house synthetic cry1c gene construct, which is a completely different gene with a different mode of action from cry1Ac or cry1Ab. It is a single gene with a broad spectrum of activity, producing toxic proteins against both bollworms and armyworm. Bt cotton cultivation is on the rise and India in 2006 became a net exporter of cotton from being an importer. These developments clearly favor for introduction of newer technologies. This can happen only if there are lesser incidents of interference from the regulators or legislators. The industry is already grappling with the issue of pricing of the Bt cotton seeds sales. Last year the seed companies were pressurized to fix the prices for Bollgard-I at Rs 750 per packet. However, recently New Delhi based representative of 15 seed companies, The All-India Crop Biotechnology Association (AICBA) announced that the various state governments and the seed industry have agreed in principle to an MRP (minimum retail prices) of Rs 925 per 450 gm packet against Rs 750 for Bollgard I cotton seeds. The industry's contention is that the pricing should be as per the market dynamics. This is the only way by which quality can be ensured and that the companies are not in red. The biopesticide and the biofertilizers market is estimated to be around Rs 80 crore. Biotech International, Excel, and Multiplex are some of the leading players in this area.         The players Mahyco (MECH and MRC) Rasi (RCH) Ankur Seeds (Ankur) Nuziveedu Seed (NSC) JK Seeds (JKCH) Nath Seeds (NCEH) Ganga Kaveri Seeds (GK) Tulsi Seeds (Tulsi) Ajeet Seeds (ACH) Emergent Genetics (Brahma) Vikki Agrotech (VCH) Pravardhan Seeds (PRCH) Krishidhan (KDCHH) Prabhat (PCH and NPH) Vikram Seeds (VICH) ]]> <![CDATA[BioServices records over 50% growth]]> https://biospectrumindia.com/news/95/1231/bioservices-records-over-50-growth.html https://biospectrumindia.com/news/95/1231/bioservices-records-over-50-growth.html Sat, 07 Jul 2007 11:34:00 +0530 New Page 1 BioServices records over 50% growth The BioServices business today accounts for 13 percent share of the total biotech industry. The BioServices sector is one of the fastest growing segments in the industry. With total revenues of Rs 1,102 crore, it was the second largest contributor to the total biotech industry after the BioPharma sector and the second fastest growing industry after the BioAgri sector. The BioServices sector registered 53.06 percent growth over that in 2005-06. The BioServices sector comprises clinical research and contract research organizations (CROs) and to some extent custom manufacturing. There are over 70 companies in India offering services in areas like data management, clinical trials, site management, bioequivalence and bioavailability studies toxicology studies, knowledge process outsourcing for pharma industry. According to industry sources, Hyderabad-based GVK Bio is the largest CRO in the country with revenues of Rs 198 crore in 2006-07. However, as per the confirmed figures, taken for the ranking purpose, Biocon subsidiary Syngene is the leading player with revenues of Rs 158 crore. Syngene registered over 71 percent growth compared to the previous year's revenues of Rs 98 crore. Quintiles registered close to 65 percent growth to record Rs 146.26 crore in revenues from India operations. Outsourcing of drug discovery research to India is on the rise. The pharma outsourcing business in India will grow to around $7 billion (Rs 28,700 crore) by 2013, according to research firm Frost & Sullivan. Another report, by Pune-based research firm Value Notes, forecasts a growth of 23.6 annually for the industry up to 2010. Today India is a very attractive destination for outsourcing services. The trend is visible. GlaxoSmithKline (GSK) signed a multi-million dollar contract with Tata Consultancy Services to establish a global drug development support center in Mumbai to help meet the demands of the growing GSK pipeline. Bristol-Myers Squibb and Biocon's Syngene have signed a research collaboration agreement. Further, many Indian companies are also forming alliances or acquiring companies to enhance their capabilities and service offerings. Manipal AcuNova's AcuNova Life Sciences formed a strategic regional alliance with Kiecana Clinical Research (KCR), based in Warsaw, Poland, for leveraging operations in South Asia, Europe and Latin America. GVK Biosciences signed a major long-term agreement with UK-based Drug Development Solutions for providing clinical data management services pertaining to clinical studies. GVK Biosciences may receive payments in excess of $2 million over a three-year period for clinical data management services. GVK Biosciences also announced a 50:50 joint venture (JV) with INC Research (INC) to form INC GVK Bio Pvt Ltd. The JV will establish a dedicated resource capability to offer Phase I-IV clinical development programs in India for INC's global clients. i3 Research, a therapeutically specialized CRO, which is part of the Ingenix, which is a global major provides integrated scientific strategies and solutions throughout the pharmaceutical product lifecycle, announced that it is expanding into India with a full-service office in Delhi. In India, i3 will provide clinical research and data services offerings for India-specific and global trials. These examples clearly suggest that outsourcing business is growing rapidly and there would be a lot of action in 2007-08.   ]]> <![CDATA[BioPharma records $1.45 billion in revenues]]> https://biospectrumindia.com/news/95/1976/biopharma-records-1-45-billion-in-revenues.html https://biospectrumindia.com/news/95/1976/biopharma-records-1-45-billion-in-revenues.html Sat, 07 Jul 2007 11:20:00 +0530 New Page 1 BioPharma records $1.45 billion in revenues The BioPharma sector registered 26.87 percent growth to record sales of Rs 5,973 crore in 2006-07. The BioPharma sector, primarily comprising vaccines, thera peutic drugs, animal biologicals, statins and diagnostics, in 2006-07, is estimated to have generated Rs 5,973 crore in revenues, recording 26.87 percent growth over the 2005-06 figure of Rs 4,708 crore. This sector still accounts for 71 percent share of the total biotech segment. The growth for this sector has mainly come from the vaccines business and other products like statins. The vaccines business alone stood at Rs 3,053 crore ($745 million) and registered 30.41 percent growth. The vaccines business, human and animal health care taken together, accounted for 51 percent share of the total BioPharma market. The diagnostics market registered a marginal growth of 5 percent. This is on account of strong competition in the Indian market place. Diagnostics business stood at Rs 950 crore. The therapeutics segment grew from Rs 640 crore in 2005-06 to Rs 725 crore in 2006-07. The human insulin market was the most significant contributor with revenues of Rs 360 crore. Novo Nordisk continues to be the leader in the human insulin business with total estimated revenues of Rs 222 crore. The BioPharma sector excluding the diagnostics sector was Rs 5,043 crore and the top 20 BioPharma companies excluding the diagnostics players accounted for 32 percent share of that figure. The top BioPharma company in the country was Serum Institute of India with total revenues of Rs 950.95 crore. It was followed by Biocon and Panacea Biotec with revenues of Rs 728 crore and over Rs 600 crore respectively. Out of the Top 10 BioPharma companies (excluding diagnostics), seven of them - Serum Institute of India, Panacea Biotec, Venkateshwara Hatcheries, Indian Immunologicals, GlaxoSmithKline, Aventis Pharma, and Shantha Biotechnics are primarily into vaccines business. The Top 5 companies accounted for 45 percent share of the total BioPharma sector and together generated in excess of $650 million in revenues. The Indian biopharma sector is export-driven. Over 61 percent of the total BioPharma revenues were from exports. The diagnostics sector in 2006-07 accounted for about 16 percent of the total biopharma sector. The market is witnessing increased competition. The diagnostic sector today has over 25 manufacturers besides over 30 players including the multinationals who are doing diagnostic business in the country. Transasia Biomedicals, Roche Diagnostics and Tulip Group of Companies are the key players in the Indian diagnostic sector. Other global vendors like Abott Healthcare, Bayer Diagnostics, and Randox Labs have also consolidated their business in India. Tulip recorded sales of Rs 165 crore in 2006-07, while TransAsia BioMedicals' sales stood at Rs 151.37 crore. According to industry estimates, Roche would also be in excess of Rs 150 crore in revenues. While the top companies have consolidated their market presence and are growing by 15-20 percent, the smaller players are facing strong competition.             ]]> <![CDATA[Alliances for Innovation]]> https://biospectrumindia.com/news/95/1552/alliances-for-innovation.html https://biospectrumindia.com/news/95/1552/alliances-for-innovation.html Sat, 07 Jul 2007 10:44:00 +0530 New Page 1 Alliances for Innovation The BioSpectrum-ABLE & IIM Bangalore Survey 2007 attempts to bring to the forefront the strategies that the Indian biotech companies can adopt in mushrooming their alliances. As companies face the pressure from increased competition, shortening product life cycles and growing product complexities, many are finding they need to change the way they develop new technologies, products and services. As companies realize they can no longer afford to rely solely on their own R&D and need to acquire ideas from others, there has been a trend in many sectors away from a mostly closed to a more open model of innovation. The innovative competence of the firm has traditionally been linked to intra-organizational factors such as R&D investments and gifted inventors (Ruttan, 2001; Schumpeter, 1955; Shane and Venkataraman, 2000). The literature review and recent research (Burt, 1992; Van de Ven et al., 1999) however, provide evidence that inter-organizational alliances play a central role in determining a firm's innovative capability by demonstrating that innovation occurs in alliances of organizations across multiple contexts Over the last two decades there has been unprecedented growth in the number of inter-organizational alliances (Hagedoorn, 2002). There has been a surge in the number of strategic alliances within the technology-intensive industries. The examples are semiconductors, computers, software, and commercial aircraft. The focus of these studies is joint R&D, product development, and higher levels of knowledge exchange and technology transfer (Mowery, Oxley and Silverman, 1996). The theoretical model that predominantly has been applied to the analysis of alliances is the resource-based view of the firm (Barney, 1991; Penrose, 1959; Wernerfelt, 1984). The central point of the resource-based view is the assumption that firms achieve and sustain a competitive advantage through heterogeneity of resources located within the firm. Preliminary results Hypothesis 1 predicts that lesser the organizing cost for the alliance, the more will be the firm's ability to internalize partner knowledge and reduce partner dependency. The coefficient for internalization in our model is coming positive, thus supporting alternate of Hypothesis 1. Hypothesis 2a predicts that lesser the organicity in the alliance structure, higher will be the internalization of knowledge. The coefficient in our model is negative but not significant, thus partially supporting the arguments. Hypothesis 2b predicts that higher the organicity in the firm's organizational structure, higher will be the recombination and application of knowledge from the said firm. The coefficient in our model is positive and significant, thus supporting Hypothesis 2b and past findings reported in the literature. Hypothesis 3a predicts that higher the openness in communication within the alliance structure, higher will be the internalization of knowledge by the said firm. The coefficient in our model is negative and not significant, thus not supporting Hypothesis 3a. Hypothesis 3b predicts that higher the openness in communication within the firm's organizational structure, higher will be the recombination and application of knowledge from the said firm. The coefficient in our model is positive and significant, thus supporting Hypothesis 3a. Also this study points out the following: Considering the smaller size of the Indian Biotech industry, the growth can be effectively managed by pooling resources (Research facilities, technological competence, manpower requirements, risk taking ability etc) and passing the knowledge between firms more quickly and effectively to catch up with the industry in the west. The latest technologies in the information and communication field could be used to achieve the same. Also the knowledge spillover can be effectively used for the industry by managing the clusters effectively. Alliances have become very popular on account of the desire by most companies to achieve higher returns in their R&D as well as operations. Innovations have become the key to survival and growth in this highly growing technological era. Owing to the limitations of knowledge resources to generate greater innovative capabilities, companies have taken the route of collaboration. Alliances provide access to complementary skills and capabilities and also bring economies of scale and scope. Chesbrough (2003) argues that the older view of successful innovation requires control which he terms as closed innovation paradigm is to be replaced with open innovation paradigm where rules are just opposite. The fundamental arguments and differences are in creating value through business models in both paradigms. The factors which fundamentally question the assumptions of the closed innovation paradigm are growing mobility of experienced people, faster time to market and the growing presence of private venture capital fund. To learn through an alliance, a firm must have access to partner knowledge and must work closely with its partner. As a result, both collaborative process and firm specific perspectives must be understood (Inkpen, 2002). While a lot of work has been grounded in the R&D innovations internally, not much work has been done to understand the model of appropriating technology from the partner and use the same in the said firm's innovative efforts. Innovation is taken as an iterative process by which a knowledge base is developed by an organization to devise and design tools and procedures for their use which decreases the uncertainty for meeting a set of needs or problems. Study of learning appropriate technology from the partner and combining it with one's own competence and diffusing it is not happened. So this research focuses on those firms with the intent to build competencies by appropriating skills, technology and other strategic capabilities from the partner. The learning alliances in the Indian biotechnology industry are chosen as the context for this study, since those alliances are predominantly for the purpose of innovation. Since our main aim is to understand alliances as causation for innovation and to find out what kind of organizational mechanism optimizes this causation. The moderating factors such as absorptive capacity, characteristic of knowledge, trust, age, size, and R&D spending are discussed. We strongly feel the learning dimension may have a significant impact on the resulting innovation from alliances. The way alliances are organized may pose either positive or negative consequences in its learning ability. Top management puts together strategic alliances and sets the legal parameters for exchange. But what actually gets traded is determined by day-to-day interactions of engineers, marketers, and product developers: who says what to whom, who gets access to what facility, who sits on what joint committees. Limited unintended transfers ultimately depend on employee loyalty and self discipline. So when we try to realize the innovative outcomes through alliances, the alliance management issues become a key in the transfer, recombination and application of knowledge from one partner to the other. The firm specific factors may also determine this outcome. The data was collected through a survey of top management with prior alliance experience. A strategic alliance involves at least two partner firms that: Remain legally independent after the alliance is formed Share benefits and managerial control over the performance of assigned tasks and Make continuing contributions in one or more strategic areas, such as technology or products (Yoshino and Rangan, 1995). The questionnaires were designed and the survey implemented according to Dillman's (2000) tailored design method. We used management doctoral students to assess whether the content of the items tapped the conceptual domain of the focal construct (DeVellis, 1991). This yielded a set of fine-tuned questionnaire items that we used in survey with CEOs of Indian biotechnology firms involved in strategic alliances. Dependent variables We measured knowledge transfer and innovation using a three-item Likert scale reflecting (1) the extent to which the firm has learned about the technology/ process know-how held by its partner, (2) the extent to which the firm has greatly reduced its initial technological reliance or dependence upon the partner since the beginning of the alliance, (3) the extent to which the technology/process know-how held by the firm's partner has been assimilated by the firm and has contributed to other projects developed With a Cronbach's alpha of 0.81, the performance scale demonstrated high reliability (DeVellis, 1991; Nunally, 1978). Independent variables We measured governing cost using a three-item Likert scale reflecting the extent to which the firm has committed time and resources for planning, monitoring and managing the alliance activities. With a Cronbach's alpha of 0.89, the performance scale demonstrated high reliability. We measured organicity and mode of communication using a six point and one point item Likert scale developed by Khandwalla (1976/1977). The Cronbach's alpha of 0.91 demonstrated a high reliability for the organicity construct. Discussion and future research Our research provides significant insights about how the alliance management issues affect the extent of internalization of knowledge, skills and competencies and the application and recombination of internalized knowledge in the firm's innovativeness when it takes an alliance route to innovation. Specifically, the study points out the need to look more intensely into the structure and management of alliances if your need is to learn for innovation. Researchers and managers ought to take into account the type of governance and structure to understand the potential for learning. In our study, the alliance, governance cost, flexibility in the structure of alliance and the mode of communication came as significant factors in the context of learning for innovation. We hope that our study will encourage future studies that will look in more detail the effect of alliance management issues in the context of learning for innovation.   Thomas Joseph Doctoral Candidate, Corporate Strategy and Policy Area Indian Institute of Management Bangalore E-mail: thomasj03@iimb.ernet.in   Note: Detailed results will be published in the future issues of BioSpectrum. ]]> <![CDATA[West Region Companies Generate $1B in Revenues]]> https://biospectrumindia.com/news/95/1475/west-region-companies-generate-1b-in-revenues.html https://biospectrumindia.com/news/95/1475/west-region-companies-generate-1b-in-revenues.html Sat, 07 Jul 2007 10:34:00 +0530 New Page 1 West Region Companies Generate $1B in Revenues Though the southern cluster is the largest in terms of number of companies headquartered in the region, it is the West, which accounts for 48 percent share of the total biotech business generated in 2006-07 by the companies incorporated in the cluster. The biotech industry in 2006-07 stood at Rs 8,541 crore in revenues, registering 30.98 percent growth, over the previous year's figure of Rs 6,521 crore. It was the year of globalization, product launches, and the industry moving through the maturity curve. The biotech industry recorded $1.2 billion (Rs 4,937 crore) revenues in exports. Exports accounted for almost 58 percent of the total revenues generated by the biotech industry. The biopharma segment recorded sales in excess of $1.45 billion (Rs 5,973 crore), accounting for 71 percent of the total industry revenues. Further, the biotech companies based in the western region of the country also generated $1 billion in revenues. The biggest biocluster in terms of number of companies headquartered in a region is the South. It accounts for 46 percent share of the total number of companies in the country. Out of the total of 330 companies profiled by BioSpectrum, the western region accounted for 41 percent share of the total base. However, the western region accounted for almost half of the total biotech revenues generated in the country by the companies based in the cluster during 2006-07 (48 percent). This biocluster has generated such high revenues mainly because it is home to almost all the top diagnostics companies. The companies based in the western region alone generate about 95 percent of the total diagnostics business in the country. South based companies generate almost 55 percent of the total CRO business in the country. Further, the top companies from each of the regions constitute the top three companies in the country. West-based Serum Institute of India is the top ranked company in India with total revenues of Rs 950.95 crore. It is followed by Biocon, which is headquartered in Bangalore with Rs 823 crore in revenues. The third ranked biotech company in the country, Panacea Biotec, is based in the North. All the regions in the country today aim to be the hub for biotech activity and are pushing up the investments through setting up new infrastructure facilities and establishing funding mechanisms. The race for dominance is expected to step up further in the forthcoming years. ]]> <![CDATA[GVK Biosciences appoints Manni Kantipudi as President]]> https://biospectrumindia.com/news/95/1064/gvk-biosciences-appoints-manni-kantipudi-as-president.html https://biospectrumindia.com/news/95/1064/gvk-biosciences-appoints-manni-kantipudi-as-president.html Thu, 14 Jun 2007 17:02:00 +0530 New Page 1 GVK Biosciences appoints Manni Kantipudi as President GVK Biosciences (GVK BIO) has appointed Manni Kantipudi as president. Manni will be responsible for operations and help GVK BIO grow as a cutting edge service provider to global pharmaceutical and biotechnology companies. Manni Kantipudi comes to GVK BIO with over 15 years of experience in the IT industry where he held several leadership positions. He was with Intel Corporation since 1992 and was the first Director of Intel India from 2000-2003 where he was responsible for strategic and operational aspects of starting, growing and sustaining its R&D development center in Bangalore. From 2003-2004, he was Asia CIO (Chief Information Officer) responsible for all internal IT for the Greater Asia region including Japan, China, Malaysia, Singapore, Taiwan, Philippines and South Asia. Most recently, he was based in the US as Director of Software and Validation for Intel's core WiFi technology Centrino laptop product line where he managed a global team of engineers and was responsible for innovative product designs and bringing key Intel products to market. Kantipudi has done his Bachelors in Computer Engineering and Masters in Computer Science.   Dr Ganesh M Kishore joins Burrill & Company Dr Ganesh M Kishore has joined Burrill & Company as its managing director. Dr Kishore joins the company to focus on Burrill's activities in Malaysia, India, and the AgBio, health and wellness, industrial biotech and biofuels sectors, in addition to Burrill & Company's general life science focus. "We are delighted to have Kish on board. His exceptional experience in the agricultural, industrial biotech, biofuels and life sciences industry particularly at the leading edge of research will be invaluable for our Venture Group at Burrill," said G Steven Burrill, CEO of Burrill & Company,. Prior to joining Burrill, Dr Kishore served as vice president, science and technology and chief biotechnology officer of DuPont. Prior to this he was the vice president, technology, for DuPont agriculture and nutrition. He joined DuPont in June 2003 and was focusing on R&D efforts related to biotechnology within the company. Dr Kishore earlier served as co-president, nutrition and consumer sector and as assistant chief scientist for Monsanto, which he joined in 1980. Dr Kishore is a founder of the plant biotech and informatics company, Metahelix Life Sciences. Dr Kishore also serves as the chairperson for the St. Louis RCGA's Bioenergy group.   ]]> <![CDATA[Metahelix Life Sciences]]> https://biospectrumindia.com/news/95/1046/metahelix-life-sciences.html https://biospectrumindia.com/news/95/1046/metahelix-life-sciences.html Thu, 14 Jun 2007 16:56:00 +0530 New Page 1 Metahelix Life Sciences Business: Agricultural biotechnology CEO: Dr KK Narayanan Biotech Revenue: Rs 7.50 crore Start-up Year: 2001 Address: Plot No. 3, KIADB 4th Phase, Bommasandra Industrial Area, Bangalore - 562 158 Tel.: 91-80-27836086 Fax: 91-80-27836084 Website: www.meta-helix.com Metahelix Life Sciences is focused on developing technologies for crop improvement. The company is dedicated to the research, production and marketing of high quality hybrid seeds. It offers services and partners with agribiotech and seed companies in the areas of functional genomics, plant genetic transformation, trait development and marker assisted crop improvement. Metahelix has produced two hybrid qualities of rice: DRH 748 & DRH 775 which have been listed among the top 3 rice varieties in India. By 2008, it plans to launch the insect protectant cotton seed variety which is presently going trough large scale trials. Its annual turnover during 2006-07 is over Rs 19 crore of which Rs 7.50 crore is from its biotech services. Its genomics division offers plant transformation and trait development, functional genomics, genetic purity testing and marker development. In the area of computational biology, the services include protein informatics, protein structure modeling and simulation of cellular processes. Apart from its Bangalore facility, Metahelix has set up a world-class seed conditioning plant and a field research station in Hyderabad. With over 190 employees and world class research center, it has become a key player in the field of agri-biotechnology and aims to become a Rs 100 crore company by 2009-10.   ]]> <![CDATA[Intas BioPharmaceuticals]]> https://biospectrumindia.com/news/95/1679/intas-biopharmaceuticals.html https://biospectrumindia.com/news/95/1679/intas-biopharmaceuticals.html Thu, 14 Jun 2007 16:52:00 +0530 New Page 1 Intas BioPharmaceuticals Business: R&D, manufacturing and marketing of biotech products Biotech Revenue: Rs 7.64 crore CEO: Dr Urmish Chudgar (MD) Start-up Year: 2001 Address: Plot No. 423 / P / A/ GIDC, Sarkhej - Bavla Highway, Moraiya 382 210, Taluka â€“ Sanand, Ahmedabad, Gujarat Tel.: +91-2717 - 660100 Fax: +91- 2717 - 251189 Website: www.intasbiopharma.co.in Intas BioPharmaceuticals Ltd (IBPL) is one of the fastest growing biopharmaceutical companies in India (CAGR 25 percent). Its sales revenue has increased to Rs 7.64 crore in 2006-07 from the previous year's sales revenue of Rs 5.19 crore with major contribution from GCSF. IBPL has a 100 percent R&D subsidiary, Indus Biotherapeutics, which has a vibrant and expert team of scientists and technical professionals. The ultra modern R&D facility is well established for microbial and cell culture based upstream processing, downstream processing and protein purity-impurity profile analysis. Its manufacturing facility includes sophisticated and modernized cGMP plant approved to manufacture microbiological and cell culture derived bulk drugs and finished product in pre-filled syringes and vials (lyophilized). It has launched three biogeneric products in the market: Neukine (rHu G-CSF), Erykine and Epofit (rHu EPO) and Intalfa (rHu IFN Alfa-2b). Its R&D team is now working on PEG G-CSF, other cytokines and hormones. IBPL's products in pipeline include recombinant products, monoclonal antibodies, introducing novel technology platforms, molecular biology, novel drug delivery systems, advanced analytical techniques and efficient manufacturing processes. Currently IBPL is executing contract research and manufacturing agreements with a European client for development, scale-up and commercial supply of a novel biotherapeutic protein.   ]]> <![CDATA[VARDA Biotech]]> https://biospectrumindia.com/news/95/1054/varda-biotech.html https://biospectrumindia.com/news/95/1054/varda-biotech.html Thu, 14 Jun 2007 16:47:00 +0530 New Page 1 VARDA Biotech Business: Integrated products and services in the field of pharmaceuticals and biotechnology Biotech Revenue: Rs 9.80 crore CEO: Vinod Bomman (MD) Start-up Year: 2001 Address: 209, Kartik Complex, New Link Road, Andheri (W), Mumbai -400 053 Tel.: 91-22-6693 5686 / 2673 0141 Fax: 91-22-66935687 Website: www.vardabiotech.com VARDA Biotech is a technology and knowledge based enterprise, offering integrated services in biotechnology and pharmaceuticals. It provides the higher end collaboration for the products and services that enhance the capability and productivity performances of its customers and business associates. Its sales revenue has increased to Rs 9.8 crore in 2006-07 against last year's sales revenue of Rs 8.7 crore. VARDA offers an ultra pure and highly thermostable recombinant Taq DNA Polymerase that has been isolated from recombinant E.coli. The same is supplied with 10X PCR buffer and an extra 100 mM Magnesium sulphate solution for condition optimization with divalent ion. It also offers Hotstart Taq and KlinTaq. Besides it offers industrial enzymes like cellulase, xylanese, serratiopeptidase, co-enzyme Q-10 (Ubidecarenone) and poultry enzymes like phytase. VARDA produces antibodies to key molecules involved in some of the thrust areas of cell biology namely, apoptosis (cancer research), NF-kB transcription factors, cell signaling pathways including DNA methylation and repair, inflammation and heat shock proteins, phosphorylated proteins, neurological disorders and toll like receptors and for infectious diseases. VARDA is a recipient of the ISO 9001:2000 certificate. It provides and delivers antibodies for the life sciences research community. It has launched educational biotechnology kits under the brand "Bio-Knowledge Kit". It has alliances with global players for product association and representation in India.   ]]> <![CDATA[Excel Industries]]> https://biospectrumindia.com/news/95/6461/excel-industries.html https://biospectrumindia.com/news/95/6461/excel-industries.html Thu, 14 Jun 2007 16:42:00 +0530 New Page 1 Excel Industries Business: Production and marketing of biopesticides and bioproducts Biotech Revenue: Rs 12.50 crore CEO: AC Shroff (CMD) Start-up Year: 1941 Address: 184/87, SV Road, Jogeshwari (W), Mumbai - 400 102 Tel.: 91-22-56464200 Fax: 91-22-26783657 Website: www.excelind.co.in Excel Industries primarily manufactures quality chemicals relevant to the needs of industry and agriculture. Excel has three business divisions â€“ agri, chemical and environment and biotech. The revenue from the agribiotech division for the year 2006-07 stood at Rs 12.50 crore as against the previous year's sales revenue of Rs 22 crore. In 2004-05, its biotech sales revenue stood at Rs 19.11 crore. The drop in the sales was mainly due to restructuring in the organization. This has affected the sales of agribiotech products. Excel Industries witnessed organizational restructuring in the last quarter of 2006-07. Under that the company has spilt into two and the agribiotech activities have moved to the other firm namely Excel Crop Care Ltd with effect from April 2007. Excel has biodynamic products and processes for dealing with environment and biotech problems encompassing municipal solid waste, putrescible wastes from the agriculture, horticulture and aquaculture industries, sewage sludge, industrial waste streams and contamination of soils and waters by hydrocarbons and other organic compounds. Its activities include sanitization, bioconversion, bio-remediation and bio-augmentation. Excel has an ongoing R&D program to develop a range of products that involves extensive use of biotechnology. The agricultural biotech products make extensive use of naturally occurring microbes such as bacteria and fungi. They are then formulated to help the farmer in nutrient management, organic matter, enrichment of the soil, biological control of fungal and bacterial diseases, soil borne diseases, protection from all soft bodied sucking insect pests and termites. The products are sold under broadly classified categories such as soil enrichers and biopesticides.   ]]> <![CDATA[Zytex (India)]]> https://biospectrumindia.com/news/95/2708/zytex-india.html https://biospectrumindia.com/news/95/2708/zytex-india.html Thu, 14 Jun 2007 16:39:00 +0530 New Page 1 Zytex (India) Business: Manufacturing and marketing of enzymes Biotech Revenue: Rs 15 crore CEO: Rashesh Doshi (MD) Start-up Year: 1947 Address: 33, New Islam Mill Compound, Mahadev Palav Marg, Currey Road (E), Mumbai - 400 012. Tel.: +91-22-2470 3231 Fax: +91-22-2470 4874 Website: www.zytex.net Zytex (India), engaged in marketing of a broad range of biotechnological products, has increased its sales turnover to Rs 15 crore in 2006-07 from previous year's sales of Rs 12 crore. Zytex offers products such as probiotics, enzymes for baking, food, animal feed and textile and garment processing chemicals. Zytex believes that product research should be backed by application development. Hence it set up an application lab in 1997 to support the customers and also to develop products from the bench scale to the customer rapidly. The application lab was further expanded to support its full-fledged formulation facility. In 2003, Zytex started its innovation start-up lab in a small way and from then on it has moved to its new state-of-the-art innovation center in January 2006. Based on research conducted at its center, it is now in the process of setting up a new production facility for a range of therapeutic enzymes and proteins. Its research laboratory is well equipped and manned with qualified professionals. It has also set up an ISO 9001:2000 certified manufacturing unit. Zytex has a strong distribution network in India and also in Asia/South East Asia. Its marketing personnel include chemists, food technologists, microbiologists and chemical engineers.   ]]> <![CDATA[Nicholas Piramal India Ltd (NPIL)]]> https://biospectrumindia.com/news/95/3523/nicholas-piramal-india-ltd-npil.html https://biospectrumindia.com/news/95/3523/nicholas-piramal-india-ltd-npil.html Thu, 14 Jun 2007 16:34:00 +0530 New Page 1 Nicholas Piramal India Ltd (NPIL) Business: R&D and marketing of biotech products Biotech Revenue: Rs 16.60 crore CEO: Ajay Piramal (Chairman) Start-up Year: 1988 Address: Nicholas Piramal Tower, Ganpatrao Kadam Marg, Lower Parel, Mumbai -400 013 Tel.: 91-22-3046 6666 Fax: 91-22-24908834 Website: www.nicholaspiramal.com Nicholas Piramal India Ltd (NPIL), one of India's largest pharmaceutical companies keen on making its presence in biotechnology space, has generated sales of Rs 16.61 crore from the sale of biotech products in 2006-07 against last year's sales of Rs 13.65 crore, registering a marginal growth. The rise in the biotech sales was because of its inlicensing agreements with companies like Biogen IDEC and Genzyme Corporation. It also increased its diagnostic sales turnover to Rs 18 crore in 2006-07 against last year's sales of Rs 16.02 crore. NPIL has made investments of 17 percent equity in Canadian biotech company Biosyntech, which has signed a scientific collaboration with NPIL. This collaboration will involve clinical studies for BST-InPod, which is being developed to alleviate the chronic pain associated with foot fat pads. The NPIL R&D product pipeline has expanded significantly with two of its phyto pharmaceutical molecules are in Phase II trials. Its lead oncology molecule P276-00 is in Phase II trials. It has signed an innovative drug development agreement with Eli Lilly, wherein Eli Lilly has given it a novel patented pre-clinical drug candidate for development in the metabolic disorder segment. NPIL has set up a proteomics facility at its R&D facility, which can accommodate about 400 scientists. The facility will help to make use of revolutionary new technologies in mass spectrometry such as SELDI TOF and MALDI TOF. This new biomarker pattern approach leads to possible identification of new biomarkers further leading to identification of new drug targets. This is a biotech approach to discover new proteins used for making new drugs.   ]]> <![CDATA[Krishidhan Seeds]]> https://biospectrumindia.com/news/95/2839/krishidhan-seeds.html https://biospectrumindia.com/news/95/2839/krishidhan-seeds.html Thu, 14 Jun 2007 16:33:00 +0530 New Page 1 Krishidhan Seeds Business: Provides high yielding healthy seeds solutions to the farming community Biotech Revenue: Rs 18 crore CEO: Sushil J Karwa (MD) Start-up Year: 1990 Address: "Krishidhan Bhavan", D3 to D6, Addln.MIDC, Aurangabad Road, JALNA â€“ 431 203, Maharashtra, Tel.: 91-2482- 230521, 230809, 234428 Fax: 91-2482-232328 Website: www.krishidhanseeds.com Krishidhan Seeds Ltd, a group company of Karwa Group of Industries has received the approval from GEAC to market its Bt cotton hybrids in 2006. It sold about 1.5 lakh packets of Bt cotton seeds during last kharif season in north and central India. Its total sales revenue for the year 2006-07 stood at Rs 18 crore from the sales of Bt cotton packets. This year it is expected to sell 16 lakh packets. Krishidhan Seeds has a team of scientists working in a well-equipped biotechnology laboratory. Its R&D spend is about 12 percent of its total sales covering both the basic and applied research in agri biotechnology. Now it is in the process of establishing state-of-the-art biotechnology laboratories in Special Economic Zones (Sezs). The research team is continuously working towards further improvement and advancement of the available technology. Although it decided to enter into GM Crops in 2001, the regulatory approval and procedures took time to launch its products only in 2006. Krishidhan Seeds is using the Monsanto technology and it was one of the three companies to launch Bollgard II, which is more effective than Bollgard I, during 2006-07. Company officials said that Krishidhan would continue to use Monsanto technology. Meanwhile, it is also in the process of looking at other technologies that would control bollworm complex and other pests. Currently, it is mainly focusing on promoting Bollgard II technology with desired tolerance to sucking pest complex in its elite hybrid.   ]]> <![CDATA[Hester Pharmaceuticals]]> https://biospectrumindia.com/news/95/1081/hester-pharmaceuticals.html https://biospectrumindia.com/news/95/1081/hester-pharmaceuticals.html Thu, 14 Jun 2007 16:24:00 +0530 New Page 1 Hester Pharmaceuticals Business: Production and marketing of poultry vaccines Biotech Revenue: Rs 22 crore CEO: Rajiv Gandhi (MD) Start-up Year: 1985 Address: 16/10, Devendra Society, Naranpura, Ahmedabad - 380 013 Tel.: 91-79- 27680476 /2250 Fax: 91 79-27681231 Website: www.hesterpharma.com Hester Pharmaceuticals registered a marginal growth in 2006-07 with its sales touching Rs 22 crore against the previous year's turnover of Rs 20.17 crore. This ISO 9001:2000 certified company is into manufacturing, marketing and distribution of veterinary medicines mainly the live and killed (inactivated) vaccines. Hester markets Synbiotics ELISA kits and also offers seromonitoring services through which it helps producers to evaluate the immune response to administered vaccines. From 1985 it was involved in the marketing and distribution of veterinary medicines. Having established the manufacturing facility in 1997, Hester has been licensed to produce 11 types of live poultry vaccines and 28 types of killed (Inactivated) poultry vaccines. Production procedures for poultry vaccines based on in-house advanced capabilities are being followed in the areas of virus propagation in specific pathogen-free embryos, tissue culture, batch fermentation of bacteria, lyophilization, emulsion preparation and strict adherence to Good Manufacturing Practices (GMP). Hester Pharmaceuticals is keen on importing avian influenza vaccines for poultry from Merial, France and the US and also FLU DETECT antigen capture test strip from Synbiotics, USA. It has been expanding its production capacity from 1.2 billion doses of poultry vaccines to 4.8 billion doses so that it can manufacture avian influenza vaccine for the poultry.   ]]> <![CDATA[Preventive Medicine Pioneer]]> https://biospectrumindia.com/news/95/1767/preventive-medicine-pioneer.html https://biospectrumindia.com/news/95/1767/preventive-medicine-pioneer.html Thu, 14 Jun 2007 16:16:00 +0530 New Page 1 Preventive Medicine Pioneer Biological E supplies most of the essential and life saving drugs to Central and state government hospitals, PSUs, the Indian armed forces and the domestic retail market. Biological E Business: Manufacturer of vaccines, formulations and APIs CEO: Dr Vijay Kumar Datla Biotech Revenue: Rs 28.23 crore Start-up Year: 1953 Address: 18/3, Azamabad, Hyderabad â€“ 500 020 Tel.: 91-40-27617835, 27615134 Fax: 91-40-27615309 Website: www.biologicale.com Biological E (BE) was established over 50 years ago. It is the first private sector biological products company in India and the first pharmaceuticals company in South India. BE is also the pioneer in preventive medicine. Biological E supplies most of the essential and life saving drugs to Central and state government hospitals, public sector undertakings, the Indian armed forces and the domestic retail market. Its international division provides global-access to high quality innovative products and caters to the health and well being of people worldwide. Biological E has structured its business into three major areas â€“ biologics, pharma and public markets. The company exports many of its products to Asia, the CIS countries, the US and Latin American countries. Beparine and Neo-Hepatex have proved to be blockbuster molecules for the company and it also produces paediatric vaccines like DPT, TT and ATS. Biological E is investing approximately $ 50 million towards the development and expansion of infrastructure. State-of-the-art equipment is being installed in all locations that will meet the US FDA and European MEA standards in manufacturing, quality control and pre-clinical activities. As per the regulatory requirements it has specialized suites for different manufacturing activities. Dedicated laboratories have also been provided to carry out testing of the quality control setup. Several projects are underway to strengthen and expand Biological E's drive to internationalize its business. One of these is the compact and well-maintained production facility to manufacture APIs in Pattancheru, which has ample scope for future expansion. Another project underway is the modern biotech facility, with an investment of Rs 100 crore, in the Genome Valley, Andhra Pradesh. It has taken up this state-of-the-art technology project to produce a new generation of vaccines, focused on reaching out to international markets. This project complies strictly with the WHO and US FDA GMP guidelines. BE features a broad range of promising projects in various stages of development. Some of these are the Haemophilus type B conjugate vaccine and DTwP-HBV-HIB combination. The DTwP-HBV combination are currently undergoing Phase-III human clinical trials and the meningitis vaccine is under research and development in which polysaccharides developed from serotypes A, C, W & Y will be mixed to formulate the vaccine. Already serotype A and C polysaccharides have been standardized. ]]> <![CDATA[Concord Biotech]]> https://biospectrumindia.com/news/95/8156/concord-biotech.html https://biospectrumindia.com/news/95/8156/concord-biotech.html Thu, 14 Jun 2007 16:12:00 +0530 New Page 1 Concord Biotech Business: Producer and exporter of enzymes, statins Biotech Revenue: Rs 45 crore CEO: Sudhir Vaid (MD) Address: 302-Sakar III, Opposite Old Gujarat High Court, Ahmedabad -380014 Tel.: 91-79-27544998, 27543557 Fax: 91-79-27540802 Website: www.concordbiotech.com Concord Biotech Ltd (CBL), an R&D based biotechnology company, having state-of-the-art fermentation facility, is one of the major players in the statins and immunosuppressants market in India. Its revenue in 2006-07 touched Rs 45 crore against last year's sales revenue of Rs 18 crore. It is expected to cross Rs 100 crore mark by this financial year, as it has commissioned a Vancomycin plant in March this year. Besides antibiotics, immunosuppressants and statins contribute a major chunk to its revenues. About 40 percent of the revenue is from exports. CBL is the largest producer of Penicillin-G Amidase enzyme. It has been exporting this enzyme to a number of companies in China, Europe and the US besides having a 90 percent market share in India. CBL also produces and exports Lovastatin and Tacrolimus to Europe and other countries. It will shortly start the production of Simvastatin and Pravastatin at its newly USFDA approved facility. CBL also undertakes custom synthesis projects in biotechnology. CBL has been adding on two new manufacturing blocks. At present it has seven dedicated blocks for enzyme, statins and immunosuppressants covering a built up area of 12-13 acres from just one and a half acres in 2000. Then it started producing Tacrolimus, Mycophenolate Mofetil, Mycophenolate Sodium. Later on, it added Pravastatin, Sirolimus to its product basket. It has dedicated plants for all these different products and has been supplying all these products to the US and most of the other regulated markets. CBL is the only company in the world, which is making all the immunosuppressants. It has taken all the necessary steps to maintain the balance of ecosystem by setting up a sophisticated facility for the treatment of the effluents generated from the process.   ]]> <![CDATA[Forward Thinking]]> https://biospectrumindia.com/news/95/1587/forward-thinking.html https://biospectrumindia.com/news/95/1587/forward-thinking.html Thu, 14 Jun 2007 16:08:00 +0530 New Page 1 Forward Thinking Wockhardt is at the forefront of developing new generation products. Wockhardt Ltd Business: Manufacturing and marketing of recombinant biopharmaceuticals CEO: Habil Khorakiwala (Chairman) Biotech Revenue: Rs 64 crore Start-up Year: Mid 1960s Address: Wockhardt Towers, Bandra Kurla Complex, Bandra (East), Mumbai - 400 051 Tel.: 91-22-2653 4444 Fax: 91-22-2653 4242 Website: www.wockhardt.com Wockhardt's biotechnology business, which has been carved out into a separate strategic business unit, has increased its revenue to Rs 64 crore during 2006-07, registering a growth of 42 percent over the previous year's biotech turnover of Rs 45 crore. Despite its efforts, it has not been able to touch its projected mark of Rs 100 crore for the year. Its biotech products â€“ Wepox (erythropoietin) and Wosulin (recombinant insulin) continued to perform well in the domestic market while Biovac-B (hepatitis B vaccine) is still facing competition to make its presence felt in the market. Considering the opportunity and market potential Wockhardt has undertaken a three-fold expansion of its biotech facility at Aurangabad in recombinant insulin capacity. The new process is automated and incorporates a series of equivalent modifications that improves quality and yield. It also got approval from ANVISA, Brazil for its biotech park. Wockhardt has about over 35 registrations for its biotech products and it already has presence in 10 markets. It received registration for Wosulin pen and cartridges for Sri Lanka and Brazil. Wockhardt has other products like G-CSF, Interferon alpha 2B and Glargine but these products are yet to gain a strong foothold in the market. Wockhardt's new drug discovery program has yielded several promising new molecules, one of which is now in Phase II human clinical trials. Wockhardt has signed an in licensing agreement with US-based Advanced Biotechnologies to market Kelocote, a patent protected product to treat scars. The clinical trials on Indian patients are in progress and clinical data from various countries has already proven its efficacy and cost-effectiveness. Wockhardt plans to launch Kelocote in India in the third quarter of 2007. This will give Wockhardt an entry into the high potential anti-scar market. Wockhardt has also entered into a marketing agreement with Bharat Biotech. In September 2006, Wockhardt signed a Memorandum of Understanding (MoU) with the Maharashtra Industrial Development Corporation (MIDC) to establish an SEZ in Aurangabad. The SEZ will be spread over 107 hectares of land leased by the MIDC at Shendra. The Wockhardt Group will establish a state-of-the-art pharmaceutical and biopharmaceutical manufacturing and research facility at the SEZ. It will provide employment to an estimated 2,000 people. Its expertise in biopharmaceuticals is backed by robust manufacturing, regulatory and marketing infrastructure, offering huge opportunities for outsourcing and potential alliances with biotechnology leaders in the US and the European Union. Further investments in biotechnology at the proposed SEZ will accelerate Wockhardt's expanding global reach.   ]]> <![CDATA[Haffkine Bio-Pharmaceutical Corporation Ltd]]> https://biospectrumindia.com/news/95/8481/haffkine-bio-pharmaceutical-corporation-ltd.html https://biospectrumindia.com/news/95/8481/haffkine-bio-pharmaceutical-corporation-ltd.html Thu, 14 Jun 2007 16:05:00 +0530 New Page 1 Haffkine Bio-Pharmaceutical Corporation Ltd Business: Supply of biopharmaceuticals to agencies/government organizations Biotech Revenue: Rs 65.69 crore CEO: Leena Mehendale (MD) Start-up Year: 1975 Address: Acharya Donde Marg, Parel, Mumbai - 400012 Tel.: 91- 22- 2412 9320 Fax: 91-22-2416 8578 Website: www.vaccinehaffkine.org Haffkine Bio-Pharmaceutical Corporation Ltd, a public sector undertaking of the Maharashtra government, bounced back in 2006-07 with its biotech turnover touching Rs 65.69 crore against the previous year's turnover of Rs 36.6 crore. It was mainly because of the United Nation's accreditation for the oral polio vaccine, which meets the desired international standards. In 2002-03, its biotech revenue had reached the peak with sales touching Rs 77.6 crore. During the year 2003-04, UNICEF had stipulated a pre-qualification consisting of very high international standards for eligibility to participate in OPV tenders. After two years of sustained efforts, including two vigorous inspections by the WHO and a team of international experts, Haffkine became the first state public sector undertaking in India to achieve such a distinction in 2006. Haffkine, which has a capacity to manufacture 600 million doses of OPV per year, achieved a sustained growth by entering into business alliances aimed at the manufacture of new vaccines of social relevance. Haffkine Bio-Pharmaceutical Corporation has slowly increased its sales from biologicals after making regular investments in upgrading its facility to meet the international standards. In 2005-06, its sales increased to Rs 36.6 crore from Rs 33.5 crore from vaccines over the previous year. It has already got the WHO contract for 2007-08 for trivalent OPV, monovalent OPV Type 1 for $5,886,000. Haffkine is involved in the development and production of a wide range of bacterial and viral vaccines for diphtheria, tetanus, whooping cough, plague, poliomyelitis and rabies. It has been importing the OPV from Indonesia, blending it and mass-producing it in its Mumbai facility for the benefit of the general public. It makes vaccines for polio and rabies, besides serums and essential pharma products. It has been supplying vaccines to government agencies and UNICEF. Haffkine has a farm and laboratory at Pimpri near Pune where antitoxins and sera for snake and scorpion venom, tetanus and diphtheria toxins are produced.   ]]> <![CDATA[The Catalyst]]> https://biospectrumindia.com/news/95/5191/the-catalyst.html https://biospectrumindia.com/news/95/5191/the-catalyst.html Thu, 14 Jun 2007 15:49:00 +0530 New Page 1 The Catalyst Advanced Enzyme Technologies produces enzymes and probiotics worth over $20 million annually and it is the largest manufacturer of serratiopeptidase. Advanced Enzyme Technologies Business: R&D, manufacturing and marketing of enzymes for different industries CEO: Chandrakant L Rathi (MD) Biotech Revenue: Rs 69.30 crore Start-up Year: 1958 Address: 5th Floor 'A' Wing Sun Magnetica, Galaxy Accolade, Next to LIC Building, Service Road, Louis Wadi, Near Teen Hath Naka, Thane - (W) 400 604 Tel.: 91-22-2583 8350 Fax: 91-22-2583 5159 Website: www.enzymeindia.com Advanced Enzyme Technologies Ltd (AETL), a leading indus- trial enzyme manufacturer in India, has registered 23.8 percent growth in 2006-07 with sales revenue touching Rs 69.30 crore. In the previous year AETL registered a growth of 41 percent with its sales revenue standing at Rs 56 crore. Besides focusing on India, AETL has been exporting its products to other countries. It has been exporting enzymes consistently since its inception. Its exports touched Rs 15 crore during 2006-07 and are expected to grow to over Rs 40 crore by next year. AETL has taken many initiatives during 2006-07 such as setting up a manufacturing facility in Indore at an investment of Rs 15 crore. It has received a process patent for leather manufacturing after two years of R&D. AETL has also forayed into the area of polyenzyme formulations. It is also keen to enter the pharmaceutical and nutraceuticals space in a bigger way. AETL's Indore plant, which is built as per the US FDA requirements, will assist in the recovery and formulation of enzymes providing ecosafe solutions for pharma and non-pharma industries. The fermentation capacity stands at 250 metric cube and will cater to the company's export market. It has invested about Rs 15 crore and another Rs 35 crore has been set aside for its expansion. The plant covers 38400 sqm of land and has the potential of employing 100 people. CL Rathi, managing director, AETL, said, "With the plant being put in place, we expect an increase in turnover by Rs 30 crore this year and Rs 90 crore in the next two years. The new facility will help us cater to various industries by providing customized solutions. We are working towards achieving sales of over Rs 200 crore of exports from AETL by 2010 and also establishing a few international manufacturing companies." Catering to a worldwide market in geographies like Europe, America, China including India, AETL specializes in providing customized, eco-safe solutions across various industries. Some of its focus areas are healthcare, animal healthcare, textiles, leather and foodgrains. An R&D focused company with 10 percent of earnings being ploughed back into research and development activities, it is poised to file for 40 patents this year as opposed to only 20 last year and 7 prior to that. Today with an investment of over $10 million, AETL's production facilities produces enzymes and probiotics worth over $20 million annually. It is also the largest manufacturer of serratiopeptidase, having perfected the art of manufacturing the enzyme over the last 15 years. AETL's multi-disciplinary R&D team comprises microbiologists, biochemists, chemical engineers, food technologists, and biotechnologists with several years of experience with enzyme technology. The R&D team at AETL has been working on disease management to health management or prevention therapy so as to provide unique non-toxic solutions through natural products such as enzymes and probiotic supplements for several lifestyle as well as communicable diseases such as obesity, cancer, and cardiovascular health, tuberculosis and leprosy. Advanced Enzyme Technologies has received a process patent for leather manufacturing. Far superior to the conventional procedure used to process hides, this process will now allow for better quality of leather in terms of its grain structure. The patented leather process is termed Eco-Friendly WET Blue Manufacturing and comes as a relief to the leather industry as there has been a major cause of concern, resulting in a clampdown on many units by the Pollution Control Board (PCB). The value of the patented process is over $200 million and is purely based on the developed technology. It took two years to develop this process and technology including the transfer to the plant scale. This process will provide a boost for the company in the leather markets and AETL plans to take its success to the American and European countries as well. CL Rathi said, "The global market for leather is valued at $98 billion and India has close to 2.5 percent share in the world market which amounts to around $2.25 billion. However, the Indian leather market is expected to double by the year 2010 to $4.5-5 billion. This is because leather technology in India is rapidly evolving to produce high quality leather using eco-friendly processes and AETL is proud to be contributing to this technology." AETL is currently the only player in the area of polyenzyme formulations, the concept of which is not new to the European and American markets. They are available across the counter under the brand names Wobenzyme and Disperzyme developed by Mucos Pharma in Germany. The sister concern of AETL, Specialty Enzymes and Biochemicals based in Chino, CA has also been manufacturing and marketing SEB kinase and EXCLzyme EN which are polyenzyme formulations. They are well accepted in these markets and are tried and tested products serving as a replacement to conventional medicines. Some of these supplements are also available in the Indian markets, but the concept of polyenzyme formulations is yet to take roots in India. Currently, AETL is striving hard not only to just introduce these novel polyenzyme products into the Indian markets and generate awareness about their manifold utilities but also to manufacture them as nutraceuticals which have no side effects and which are completely natural products. To bring awareness about the benefits of enzymes in different industries, AETL has been participating in seminars and conference not only in India but also in other countries as well. In India it had organized a seminar on biotechnology and its applications in animal nutrition and healthcare in New Delhi which saw the participation of veterinarians. Around the world, Advanced Enzyme Technologies' team of 180 people are working in pursuit of delivering excellence to its customers through quality products and unparalleled customer service.   ]]> <![CDATA[Healthcare Specialist]]> https://biospectrumindia.com/news/95/2506/healthcare-specialist.html https://biospectrumindia.com/news/95/2506/healthcare-specialist.html Thu, 14 Jun 2007 15:41:00 +0530 New Page 1 Healthcare Specialist Bharat Biotech was established in 1996 with the objective of manufacturing unique vaccines and biotherapeutics. Bharat Biotech International Business: Manufacturer of human vaccines and biopharmaceuticals CEO: Dr Krishna M Ella Biotech Revenue: Rs 70.27 crore Start-up Year: 1996 New initiatives: Manufacture of human rabies vaccines, formulation of various vaccines and biopharmaceuticals. Address: Road No. 65 Jubilee Hills, Hyderabad Tel.: 91-40-23480567/55510150 Fax: 91-40-23480560 Website: www.bharatbiotech.com Hyderabad-based Bharat Biotech International Ltd (BBIL) is a multidimensional biotechnology company specializing in product-oriented research, development and manufacturing of vaccines and biotherapeutics through innovative and collaborative research. Bharat Biotech has set a precedent in this emerging area with the manufacture of HibTITER (Haemophilus Influenzae b Conjugate Vaccine) for Wyeth Lederle Ltd. This was the first time that a vaccine was moved out of the US for manufacturing in India. BBIL is also manufacturing a cancer therapeutic for US-based Agennix. Bharat Biotech International has a strategic alliance with Novavax to pursue the rapid development of pandemic influenza vaccine for India and other ASEAN markets. Under the terms of the agreement, Bharat Biotech will fund all pre-clinical and clinical development, work with Novavaxon optimal manufacturing processes, and be responsible for the commercialization of the vaccine. In return Novavax will receive unrestricted access to all pre-clinical and clinical data, and a royalty on all sales. BBIL has also signed a license agreement with ThromboGenics NV for manufac-turing, clinical development and commercialization of THR-100, a novel variant of recombinant staphylokinase, in developing countries and certain industrialized countries. THR-100 is a thrombolytic agent developed for treatment of acute myocardial infarction (AMI or heart attack) and other vascular diseases based on its ability to dissolve blood clots. In return for granting this license, ThromboGenics will earn double digit royalties on net sales. Bharat Biotech will assume responsibility for all future costs. THR-100 has completed Phase II clinical trials in Europe for treat-ment of AMI in over 140 patients. Bharat Biotech, with its core vaccine competence, has indigenously developed and introduced for the first time as one of its kind, chromatographically purified vero cell vaccine, INDIRAB in December 2006. INDIRAB can be used for both for prophylactic vaccine (pre-bite) and therapeutic (post-bite) treatments. Recently, UK-based Acambis announced the launch of clinical trials of its new, single-dose Japanese Encephalitis (JE) vaccine in children in India in collaboration with Bharat Biotech. Once approved, the vaccine will be marketed and distributed in India and neighboring countries by Bharat Biotech.   ]]> <![CDATA[The Veterinarian]]> https://biospectrumindia.com/news/95/1634/the-veterinarian.html https://biospectrumindia.com/news/95/1634/the-veterinarian.html Thu, 14 Jun 2007 15:38:00 +0530 New Page 1 The Veterinarian Intervet India is one of the largest MNCs in India dedicated to animal health. It offers a range of products consisting of biologicals, therapeutics and productive hormones. Intervet India Business: R&D and manufacturing of veterinary biologicals CEO: Dr Lino Componovo (MD) Biotech Revenue: Rs 80.58 crore Start-up Year: 1997 Address: Intervet House, 33, Pune-Nagar Road, (Behind Eden Gardens), Pune - 411 014 Tel.: +91-20-66050400-01 Fax: +91-20-66050410 Website: www.intervet.co.in Intervet India's sales from biotech stood at Rs 80.58 crore for 2006-07 against last year's turnover of Rs 65.52 crore. Intervet India offers a range of products consisting of biologicals (live stock, companion, poultry live and inactivated), therapeutics (antiprotozoan, antibiotic, ectoparaciticides, endoparaciticides, suppotives), productive hormones to the farming community in the country. Intervet India, a 100 percent subsidiary of Intervet International with its headquarters at Boxmeer, The Netherlands. Functioning from the 1970s, Intervet India is one of the largest MNCs in India dedicated to animal health. It is the result of autonomous growth and subsequent mergers of well known and leading companies like Hoechst Roussel Vet, Intercare and BAIF's animal health division, with a strong focus on the market and its customers. Intervet India was established in 1997 in Hyderabad with poultry vaccines, canine products and fertility hormones. In 1999, the International merger between HRVet and Intervet International resulted in the merger between HRVet India and Intervet India in the year 2000. In 2004, it shifted its base to Pune and extended its production and supporting operations for the biological segments. Intervet India has a state-of-the-art factory producing biologicals, specially FMD vaccine located at Wagholi near Pune. Intervet India's facility complies with Indian and International standards such as WHO GMP, ISO 9001, etc. The distribution of Intervet's products takes place through a network of agents ensuring cold chain maintenance and subsequent distribution through 900 distributors. It also exports its products to other countries in Asia, Europe, Latin America and Africa. It has become a partner in governmental livestock improvement programs e.g. FMD eradication. It has more than 100 technically well-trained field employees, supporting the farmers and veterinarians in disease prevention and livestock improvement. It has set up an R&D site in Pune for FMD, other veterinary biologicals and pharmaceuticals. Intervet India's operations in Pune are part of Intervet International's network and hence having access to the latest technology and know-how. Intervet India has entered into a partnership with an NGO, BAIF Development Research Foundation to improve disease management and productivity at rural level, as well as promoting livestock healthcare awareness. The partnership also offers self-employed farmers in remote villages to access to vital veterinary products at a fair price. Intervet has received 2000-01 AIBA award in the category of biotech industry units, in recognition of the R&D achievements in the promotion of biotechnology in the country. In 2005, Intervet India signed an in licensing agreement with the National Research Development Corporation, under the Department of Scientific & Industrial Research to commercialize the know-how for the process for Peste des petits ruminants (PPR) vaccine developed by the Indian Veterinary Research Institute. The agreement between NRDC and Intervet will check the PPR disease and prevent large-scale losses.   ]]> <![CDATA[TB Fighter]]> https://biospectrumindia.com/news/95/1773/tb-fighter.html https://biospectrumindia.com/news/95/1773/tb-fighter.html Thu, 14 Jun 2007 15:23:00 +0530 New Page 1 TB Fighter Eli Lilly India has committed $50 million to fight Multi-Drug Resistant Tuberculosis (MDR-TB). Eli Lilly & Company (India) Business: Marketing of pharmaceutical products CEO: Sandeep Gupta (MD) Biotech Revenue: Rs 112 crore Start-up Year: 1993 Address: Plot No. 92, Sector 32, Institutional Area, Gurgaon - 122 001 Tel.: 91-124-2823000 Fax: 91-124-2823012 Website: www.lillyindia.co.in Eli Lilly India is among the fastest growing pharmaceutical companies in India and is present in diabetes, oncology, bone health and growth and critical care drug segments and derives 60 percent of its Indian revenues from the insulin segment. This year Eli Lilly launched HumaCare Junior, a new drug for juvenile diabetics. The company intends to deliver this drug free of cost to deserving children who suffer from Type I diabetes. Under the Peaks and Valley Complications Check (PVCC) program, the company targets to provide free medical treatment to 50,000 high-risk diabetics in the next three years. Late last year, it had launched Alimta, used in treating a rare type of cancer. It also has an approved second line of treatment for non small-cell lung cancer. Earlier this year, the company acquired Hypnion, a neuroscience drug research company. Eli Lilly also entered into a pre-clinical drug development agreement with Mumbai-based Nicholas Piramal to develop and commercialize a select group of its pre-clinical drugs of multiple therapeutic areas. Under the deal, Eli Lilly would make milestone payments of up to $100 million and royalties on sales upon successful launch of the drugs. In August 2006, Hyderabad-based Suven Life Sciences signed an agreement with Eli Lilly to collaborate on the pre-clinical research of molecules in the therapeutic area of central nervous system (CNS) disorders. Scientists from both companies would work together with the goal of identifying potent oral compounds that selectively modulate the specified "G- Protein Coupled Receptor" for the target CNS disease. For its R&D, Eli Lilly has identified Asia as an important destination and the company invested $150 million in its Singapore research center. In November 2006, it outsourced a range of clinical data management services to Tata Consultancy Services (TCS), which has built a facility near New Delhi dedicated to Eli Lilly work. The company also committed $50 million to fight Multi-Drug Resistant Tuberculosis (MDR-TB). The campaign is carried out in an international partnership with 14 public and private organizations around the world, and takes the company's global financial commitment to the cause to $120 million since 2003. Eli Lilly does not sell any TB drugs in India but provides WHO-approved programs with its two MDR-TB drugs at subsidised rates. Eli Lilly is in the process of submitting documents to the Drug-Controller General of India on Byetta, an injectible medicine for people with type II diabetes. Byetta was recently launched in parts of Europe.   ]]> <![CDATA[The Trend Setter]]> https://biospectrumindia.com/news/95/1198/the-trend-setter.html https://biospectrumindia.com/news/95/1198/the-trend-setter.html Thu, 14 Jun 2007 15:18:00 +0530 New Page 1 The Trend Setter As the first Indian company to launch an r-DNA vaccine in 1997, Shantha heralded a new beginning for biotechnology in India. Shantha Biotechnics Business: Research, development, manufacture and marketing of biotechnology-based human health care products CEO: KI Varaprasad Reddy Biotech Revenue: Rs 115 crore Start-up Year: 1993 Address: Serene Chambers, 3rd Floor, Banjara Hills, Road No. 7, Hyderabad - 500 034 Tel.: 91-40-23548507 Fax: 91-40-23548476 Website: www.shanthabiotech.com Shantha is the pioneer in India for modern biotech products for human healthcare. Its r-DNA Hepatitis B vaccine, Shanvac-B and Shantetra (combination of DPT and hep B) are pre-qualified by WHO, Geneva for supplying to UN agencies. Shanvac-B is the first Indian hepatitis B vaccine to be pre-qualified by WHO. Shantha caters to major international markets including Asia-Pacific, Africa, CIS and Latin America in addition to supra nations like UNICEF and PAHO. Shantha aims to expand its current vaccines portfolio by launching combination vaccines and new generation vaccines produced indigenously at its WHO cGMP plant near Hyderabad. Shanvac-B is exported to more than 50 countries. Other novel products developed by Shantha include Shanferon (r-DNA Human Interferon Alpha 2b) and Shanpoietin (recombinant human Erythropoietin). Shantha Biotechnics and Merieux Alliance announced a strategic alliance to create a global R&D hub for prophylactic vaccine research in India. In association with Shantha Biotechnics, the European company, which has a strong presence in preventive medicine, aims to develop a global strategy for managing the infectious diseases segment. Shantha is conducting exploratory research in the fields of oncology, infectious diseases and platform technologies. It has also filed an IND for monoclonal antibodies in the US at the end of last year. By early 2007, the company has initiated trials on monoclonal antibodies and is working on four monoclonal antibodies mainly focusing on cancer and genetic disorders. Most of these would be ready by the end of 2007. Shantha is also planning to develop a single dose Hepatitis B vaccine, which will not only reduce the pain but also ensure that the subjects do not miss the doses, as it happens with the currently available vaccines. It may take another 2-3 years to launch this vaccine. It is also working on typhoid conjugate, pneumococcal, cellular pertusis and serum free vaccines for DPT. Rotavirus vaccine will also be an important part of the company's portfolio, which is likely to take four years for development. The company is also planning to develop JE vaccine, vaccine for varicella-zoster and heat stable vaccines. Shantha has tied up with Cambridge Biostability, which is a university spin-off company. The company hopes to be in a position to launch heat stable vaccines in another 2-3 years. Shantha has expanded its current facilities at Hyderabad by adding three new blocks including facilities for mammalian cell culture, viral vaccines and warehouses to stock vaccines. It has opened its new cGMP compliant state-of-the-art high speed vaccine vial filling sft facility, which will have a capacity to fill and finish 3,00,000 vials a day. Set up at a cost of Rs 25 crore, this 80,000 sft is part of Shantha Biotechnics' strategic expansion plans focused on servicing existing and growing market demands for its range of vaccines. Apart from hepatitis B, DPT-Hep B and tetanus toxoid, the vaccines under development like Human Pappiloma Virus (HPV) and Rotavirus and the soon to be launched pentavalent vaccine will be formulated and blended in this new facility.   ]]> <![CDATA[Anti-rabies Vaccine Leader]]> https://biospectrumindia.com/news/95/1357/anti-rabies-vaccine-leader.html https://biospectrumindia.com/news/95/1357/anti-rabies-vaccine-leader.html Thu, 14 Jun 2007 15:15:00 +0530 New Page 1 Anti-rabies Vaccine Leader Aventis Pharma leads the anti-rabies vaccine market in India, having a market share of 60 percent. Aventis Pharma Business: Marketing of biotechnology products CEO: Dr Shailesh Ayyangar (MD) Biotech Revenue: Rs 119.65 crore Address: Aventis House, 54/A, Sir Mathuradas Vasanji Road, Andheri (East), Mumbai - 400 093 Tel.: 91-22â€“28278000 Fax: 91- 22-28370939 Website: www.aventispharmaindia.com Although there was a drop of 8 percent in its market share, Aventis Pharma continued to lead the anti-rabies vaccine market in India having a market share of 60 percent. This drop was mainly because of competition in the market with competitors increasing their presence in the market. Aventis Pharma markets the rabies vaccines under the brand Rabipur. Besides vaccines, it is also into insulin glargine business with its product Lantus. Its overall biotech sales for the year 2006-07 reached Rs 119.64 crore. In 2005-06, its biotech turnover stood at Rs 114.5 crore against the previous year's sales of Rs 84.3 crore. Besides Rabipur, Aventis sells other vaccines such as Vaxem HIB and Imovax Polio. Lantus, the world's first long active Insulin glargine is a star in its portfolio for diabetes treatment in India. To bring awareness about the diabetes management, Aventis has launched a unique patient education program Sath 7 that has a dedicated team of five counselors, who work in close cooperation with doctors to educate patients on insulin use, diet, exercise, and other issues related to diabetes management. It has given successful results in terms of sales too. Lantus is gaining acceptance as the preferred way to treat patients of diabetes. It is now the fourth largest insulin brand in the country. Although Aventis Pharma does not conduct any basic research, it has carried out process development and clinical trials for existing and future products. A large-scale practice survey of diabetes management across the country was completed in over 100 centers covering 1,300 patients. The second wave of the study will be conducted during the year in another 8 diabetic centers. Another clinical survey in patients of gastric cancer was completed in over 300 cases in four cancer hospitals in India. Another study was carried out in over 500 diabetic patients who failed to respond to oral treatment to observe the effects of insulin treatments including Lantus. A study of Lantus in fasting patients of diabetes demonstrated its safety and the results were presented in an international conference held in Morocco. Aventis has two manufacturing facilities at Ankleshwar and Goa. Its Ankleshwar site is shared with Chiron Behring Vaccines Pvt Ltd (CBVPL) and Aventis CropScience. The CBVPL is a JV company in which Aventis holds 49 percent stake. CBVPL will manufacture anti rabies vaccines for Aventis upto April 2008.   ]]> <![CDATA[Novel Concepts]]> https://biospectrumindia.com/news/95/1394/novel-concepts.html https://biospectrumindia.com/news/95/1394/novel-concepts.html Thu, 14 Jun 2007 15:11:00 +0530 New Page 1 Novel Concepts With growing competition from the local low-priced products, GSK has initiated novel concepts to bring awareness on the use of vaccines in the country. GlaxoSmithkline Pharmaceuticals Business: Engaged in the sale of vaccines CEO: Dr Hasit B Joshipura (MD) Biotech Revenue: Rs 120 crore Start-up Year: 2001 Address: GSK House, Dr Annie Besant Road, Worli, Mumbai - 400030 Tel.: 91-22-24959595 Fax: 91-22-24935358 Website: www.gsk-india.com GlaxoSmithKline Pharmaceu- ticals (GSK) continues to lead the Indian representative vaccines market by registering a growth of over 27 percent with its biotech sales reaching Rs 120 crore for the year 2006-07 against the last's sales revenue of Rs 94 crore. GSK had registered sales of Rs 77.8 crore for the year ending March 31, 2005 with growth rate of about 27 percent over the previous year. A slight rise in its growth rate is due to its awareness initiatives taken by the company during the previous year. In India it markets 13 types of vaccines and leads in vericella, haemophilus conjugate, hepatitis A, diphtheria and typhoid vaccines space. With growing competition from the local low priced products, GSK has initiated novel concepts to bring awareness on the use of vaccines in the country. GlaxoSmithKline in India, an affiliate of GSK Biologicals, has set up a state-of-the-art vaccines filling facility at Nasik conforming to cGMP norms. GSK is set to launch Carvedilol, a cardiovascular drug from Swiss drug maker Roche. It is also in discussions with Japanese and American companies for similar deals. GSK India has divested the agrivet farm care business to Virbac Animal Health India, a 100 percent subsidiary of France-based Virbac in July 2006 for a consideration of Rs 207.1 crore. Over the last few years, GSK's strategy has been focused on growing the pharmaceuticals business by concentrating on the organic growth of its key assets in the priority range, including Augmentin and vaccines and on the introduction of New Chemical Entities (NCEs)/in-licensed products to improve its market presence, particularly in the chronic segment. GSK Biologicals has identified India as a major center for clinical research across a number of disease areas, which are relevant to India such as cancer, psychiatric disorders and infectious diseases. GSK India has made excellent progress in the last couple years and has proven itself for its quality, speed and cost effectiveness. It has identified 6 oncology centers to conduct early phase studies in India, which are being developed with the expertise of the Institute of Cancer Medicine, University of Oxford. In 2006, GSK India participated in more than 15 global clinical studies spanning across six therapy areas involving 200 patients. It has tied up with TCS for a data management deal, where GSK Plc's worldwide clinical trial data would be managed by TCS.   ]]> <![CDATA[Poultry Passion]]> https://biospectrumindia.com/news/95/2298/poultry-passion.html https://biospectrumindia.com/news/95/2298/poultry-passion.html Thu, 14 Jun 2007 14:59:00 +0530 New Page 1 Poultry Passion Venkateshwara Hatcheries dominates the Indian poultry vaccines market with a share of over 60 percent. Venkateshwara Hatcheries Business: Engaged in R&D, production and export of vaccines and diagnostics kits CEO: Anuradha Desai (Chairperson) Biotech Revenue: Rs 190.50 crore Start-up Year: 1971 Address: Venkateshwara House, SN 114/A/2, Pune - Sinhgad Road, Pune - 411030 Tel.: 91-20- 24251530-40 Fax: 91-20-24251077/ 24251060 Website: www.venkys.com Venkateshwara Hatcheries Pvt Ltd (VHL), a group company of the VH Group, continued to dominate the Indian poultry vaccine market with a market share of over 60 percent. "The biotech sales revenue for the year 2006-07 stood at Rs 410 crore, against the previous year's sales of Rs 280 crore. In 2004-2005, the biotech sales turnover stood at Rs 188 crore. During the last financial year, its biologicals sales revenue touched Rs 296 crore and this includes exports, internal use and selling in the domestic market. The rest was from the sales of Specific Pathogen Free (SPF) eggs, which are used in the production of vaccines," said OP Singh, CEO, Venkateshwara Hatcheries Group. However, industry officials say that the current poultry vaccine market is about Rs 130 crore, with Venkateshwara Hatcheries leading the market followed by Indovax and Hester Pharmaceuticals with some imports. The Rs 3,185-crore VH Group is the largest fully integrated poultry group in Asia. It has many divisions and subsidiary companies, which are working on developing biotech products. Looking ahead, it plans expansion into the related upstreaming and downstreaming areas to cater to the increasing demand for all animal and human vaccines. In 2006-07, the company increased its investments in R&D from 17 percent to 22.8 percent of its total sales revenue so as to develop future products. Besides being into poultry vaccines business and livestock management and healthcare, VHL is now working on launching vaccines for large animals and human beings and also diagnostic kits. Hence it has set up separate division called BV Biologicals. BV Biologicals, specialized in livestock management and healthcare, has set up India's largest biocontainment plant at the Rajiv Gandhi Biotech Park, Hinjewadi, Pune. It is a BSL-3 Category Biosafety level plant with state-of-the-art containment processes and has closed operating systems with carefully monitored functional procedures that make it one of the safest bio-containment facilities. The plant will accelerate important scientific work to develop vaccines for Foot and Mouth Disease (FMD) as per WHO and cGMP norms. It will have a highly controlled environment in which vaccine production and testing can be carried out using state-of-the-art technology to respond more effectively to events such as an animal disease outbreak and food safety concerns. OP Singh said, "Our aim is to explore the challenges posed by bioterrorism and other emerging infectious diseases in the country. Biosecurity and biocontainment strategies will help us reduce the risk of disease and ensure that microorganisms don't thrive and proliferate to the community or environment." In addition, the facility also has a potential to provide containment for any kind of virus that is identified as a threat to the nation. Diseases such as anthrax, SARS, avian influenza, can be quickly and safely controlled through this facility by means of respective vaccine development. The plant has high-end utility systems, autoclaves, sanitizable surface, special biosafety cabinets, and contingency plans to take care of any eventuality. BV Biologicals will manufacture and market biotech products engineered to suit the large animal health sector, mainly cattle, sheep and goat. It has entered into a joint venture with DeLaval for marketing mastitis prevention products. Under the MoU, DeLaval will provide technical support to BV Biologicals for products such as Dipal, Dip Cup, California Mastitis Test Kit and California Mastitis Test Reagent. BV Biologicals will operate and supply the products to all customer segments in India. VHL has also entered into a tie-up with a US-based company for biodiagnostics and biogeneric products. The aim of this tie-up is to bring in certain new molecules for diseases such as cancer. "We will roll out three diagnostic kits for HIV, ovulation and cancer markers in the next six months time," said OP Singh. VHL is also investing in new vaccines and biotherapeutics for child and adult immunization. There are plans to enter the protein drug sector as well. The team at BV Biologicals is working on human vaccines for ailments that afflict a majority of the common populace. VH Group exports its products to SAARC countries, South Asia, Middle East, Japan, Europe and Africa. It sells poultry vaccines from Ventri Biologicals and vitamin premixes, therapeutic products, growth promoters and dewormers from its animal health products division for the poultry industry ensuring better health and enhancing performance in breeders as well as commercial layers and broilers. Ventri Biologicals, the vaccine division of the VH Group is a leader in poultry vaccines business in India. Started in 1980, the division produces vaccines for Marek's disease and Newcastles's disease. The plant was built in collaboration with US-based Tri Bio Laboratories, a world leader in vaccine technology and research. Its vaccine plant is acknowledged as one of the most modern plants and is capable of meeting the demands of the projected growth of the Indian poultry industry. Backed by extensive and modern research and development facilities, Ventri Biologicals is constantly engaged in developing new generation vaccines, to combat emerging bacterial and viral diseases. It produces vaccines conforming to British Pharmacopeia and other international standards. About 180 employees are working in this division. The division works in close association with the Poultry Diagnostic and Research Center (PDRC) that provides the technical service and carries out disease surveillance across the country. VHL has set up 87 service centers and seven research stations across the length and breadth of the country. This helps in understanding the customer needs and relating new developments to fulfill these needs. It produces live and inactivated viral vaccines using complex cell culture and egg adapted technology with highly immunogenic vaccine virus strains in sterile atmosphere, using Specific Pathogen Free (SPF) eggs. For bacterial inactivated vaccines, it has adopted the most advanced programmed biofermentation technology. Ventri Biologicals provides a wide range of poultry vaccines, some of which have been introduced for the first time as solutions to the ongoing problems of the Indian poultry industry. Its Venkys (India) Ltd has entered into a technical collaboration with US-based Spafas for the production of Specific Pathogen Free (SPF) eggs. It is the second largest SPF egg producer in the world and the only one in Asia to manufacture Specific Pathogen Free eggs which have wide application in the production of variety of embryo based and cell culture derived viral vaccines, cell line development and research work in the area of biomedical and biosciences. It produces over 10 million such SPF eggs per annum.   ]]> <![CDATA[Insulin Leader]]> https://biospectrumindia.com/news/95/8120/insulin-leader.html https://biospectrumindia.com/news/95/8120/insulin-leader.html Thu, 14 Jun 2007 14:55:00 +0530 New Page 1 Insulin Leader Novo Nordisk India enjoys a lion's share in the Indian insulin market.   Novo Nordisk India CEO: Melvin Oscar D'Souza (MD) Biotech Revenue: Rs 222 crore Business: Diabetes care products, human growth hormone and haemostasis management. Start-up Year: 1990 Address: 8th Floor, Raheja Towers, East Wing, 26/27, MG Road, Bangalore- 560 001 Tel.:  91-80-25327447 Fax : 91-80-25594409 Website: www.novonordisk.co.in Novo Nordisk India is the Indian subsidiary of Novo Nordisk, a focused healthcare company and a world leader in diabetes care. In May 2006, it launched Levemir, a basal insulin analogue that works on the mechanism of prolonging action. The insulin is delivered to the patient through a pen like mechanism. Novo Nordisk India's Levemir FlexPen is priced at Rs 930 for a 300 IU pen, on par with other analogues in the market. Novo Nordisk India has increased its sales force that cover 30,000 doctors manning diabetic clinics in India to recommend the use of Levemir. It imports Levemir from Denmark. The company expects to capture one-fourth of India's basal insulin market this year. Novo Nordisk India has an exclusive agreement with Torrent Pharma for the manufacture of insulin formulations. Torrent Pharma has been manufacturing insulin for Novo Nordisk's India requirement for more than 15 years now. Its site for insulin production is dedicated for Novo Nordisk products, and complies with global norms. On numerous occasions, Torrent has won awards for Best Maintained Manufacturing Site of Novo Nordisk worldwide. The facility has state-of-the-art technology in formulation, filling, inspection and packaging of Novo Nordisk India insulin formulations. This plant will meet Novo Nordisk India's estimated requirements in the future. Besides marketing a portfolio of therapeutics products like NovoPen 3, Novolet and Flexpen, it has its basket products like NovoMix 30 (premixed insulin analogue) and NovoRapid (rapid acting insulin analogue). It has a distributorship alliance with Abbot India. Novo Nordisk India has an agreement with TCS for offshore clinical operations service. TCS provides a suite of data management services, which include designing, capturing, and coding of trial data gathered from clinical trials that are run by Novo Nordisk across the world, out of its modern BPO facility in Mumbai. The genesis of Novo Nordisk India dates back to 1990 when a liaison office of Novo Nordisk A/S, was set up in Mumbai. Prior to this, Novo Nordisk A/S products were marketed in India through various other companies. Even then, Novo Nordisk was involved in creating awareness on diabetes care with the help of healthcare professionals in India. On April 1, 1994, Novo Nordisk (I) Pvt Ltd was set up with its headquarters in Bangalore with 26 employees. It has now been rechristened as Novo Nordisk India Pvt Ltd. In 1998, recognizing the intense need to provide awareness and education in healthcare in India, the Novo Nordisk Education Foundation (NNEF) was founded. NNEF is a non-profit organization, with a mission of â€œEnhancing healthcare through awareness and educationâ€?. Novo Nordisk India's therapeutic product and services portfolio comprises diabetes products, human growth hormone and haemostasis management.     ]]> <![CDATA[Transgene Developer]]> https://biospectrumindia.com/news/95/2513/transgene-developer.html https://biospectrumindia.com/news/95/2513/transgene-developer.html Thu, 14 Jun 2007 14:50:00 +0530 New Page 1 Transgene Developer Nuziveedu Seeds is working on its own indigenous transgene to combat bollworms and these technologies are expected to be commercialized soon. Business: Manufacturer of hybrid cotton seeds CEO: M Prabhakar Rao Biotech Revenue: Rs 226.42 crore Start-up Year: 1973 Address: 7C, Surya Towers, 105 SP Road, Secunderabad â€“ 500 003 Tel.: 91â€“40-27898008/55334300 Website: www.nuziveeduseeds.co.in   Secunderabad-based Nuziveedu Seeds Ltd (NSL) had the commercial release of two Bt hybrid cotton varieties following the approval from the Genetic Engineering Approval Committee (GEAC). The two Bt hybrid cotton varieties, Bt Bunny and Bt Mallika, is being sold in Maharashtra, Gujarat, Madhya Pradesh, Andhra Pradesh, Karnataka and Tamil Nadu. The economic benefits to the farmer is in the region of Rs 30,000 per hectare under irrigated conditions. Nuziveedu has sourced the technology from Monsanto-Mahyco to give superior bollworm-resistant cotton hybrids. It is also working on its own indigenous transgene to combat bollworms. These technologies are expected to be commercialized in one to two years resulting in healthy competition and price reduction. The company has produced five lakh packets of these Bt hybrid seeds for cultivation during kharif. Nearly 1.2-1.5 lakh packets was sold in Andhra Pradesh. The cost per packet works out to Rs 1,818 of which Rs 1,250 went to Monsanto, owner of the technology. The nature of the contract with Monsanto-Mahyco was in perpetuity even as Nuziveedu works on its own technology to develop similar varieties. Nuziveedu also has a 15-strong cotton hybrid pipeline, two of which are undergoing last trials. Besides, it is also looking at Bt varieties in the crops of rice and brinjal. To serve effectively a client base of 65 lakh farmers, NSL has a strong marketing network comprising 1,395 distributors and dealers and over 20000 sub-dealers spread across 12 states of the country. Keeping pace with the ever-growing demand for NSL products, NSL has set-up regional offices at Secunderabad, Delhi, Akola, Ahmedabad, Guntur, Davangere assisted by C&F Agents at Indore, Trichy, Bhatinda, Hissar and Patna. Nuziveedu Seeds has recently signed a Memorandum of Understanding (MoU) with the Tamil Nadu Industrial Development Corporation (TIDCO) to establish an IT/ITeS special economic zone at Shollinganallur, on Chennai's IT corridor, at an investment of Rs 1,500 crore (Rs 15 billion). The SEZ, which is to come up on a 66-acre site, will offer space for IT and ITeS services and biotech companies also. The approval for setting up the SEZ has already been obtained from the Center. NSL has also made an entry into sugar industry. The SCM sugar project in Karnataka is of 3,500 TCD cane crushing capacity with a state of the art 26 MW cogeneration power plant to meet captive power requirements of the sugar plant and exports power to state grid. ]]> <![CDATA[Bt Cotton Maker]]> https://biospectrumindia.com/news/95/2648/bt-cotton-maker.html https://biospectrumindia.com/news/95/2648/bt-cotton-maker.html Thu, 14 Jun 2007 14:43:00 +0530 New Page 1 Bt Cotton Maker Rasi Seeds accounted for 29 percent of the total Bt cotton seeds sold in India in the year 2006. Business: Producing and marketing agri-biotechnology products CEO: M Ramasami (MD) Biotech Revenue: Rs 333.33 crore Start-up Year: 1973 Address: 273, Kamarajanar Road, Attur, Salem - 636 102, Tamil Nadu Tel.: 91-4282-241007/242007 Fax: 91-4282-242558 Website: www.rasiseeds.com Rasi Seeds has achieved a total turnover of over Rs 340 crore during the year 2006-07. It is a leading seed company located at Attur near Salem in Tamil Nadu. The company is committed to serve the needs of farmers across India by supplying quality seeds of various crops. M Ramasami, the founder and promoter of Rasi Seeds, is a graduate in agriculture and has 30 years of experience in the seed industry. Rasi Seeds was started as partnership firm in 1973 and transformed into a privately held company in 1986. Its R&D center has been recognized by the Department of Scientific and Industrial Research (DSIR), Ministry of Science and Technology, Government of India. Rasi's product coverage measures an impressive figure of more than 10 million acres in the past decade. The company has undertaken limited field trials and large scale trials of several Bt cotton hybrids since kharif 2002. The GEAC has approved RCH 2 Bt cotton hybrid during 2004 for commercial cultivation. A total of 16 Bt cotton hybrids have been approved for commercial cultivation during the last four years. Thus, Rasi has emerged as a leader in Bt cotton seed distribution in India. M Ramasami has been conferred with Velanmai Chemmal Award from the Tamil Nadu Agricultural University for his outstanding contribution to the seed industry. He was also chosen the BioSpectrum Person of the Year 2006. The company ranked fifth in the BioSpectrumâ€“ABLE Industry Survey 2006 last year. It has been conferred with the National Award 2005 for "Successful commercialization of Bt cotton technology" during November 2005, by the Department of Scientific and Industrial Research, Ministry of Science and Technology. Apart from cotton, the company is concentrating its research efforts in other crops and has also released promising hybrids in maize, sunflower, bhendi, bottle gourd, ribbed gourd, bitter gourd, tomato and chilli for the benefit of the farming community. Currently the company is focusing its research efforts for crop improvement through Recombinant DNA technology (Genetic Engineering), in vitro plant tissue culture, molecular biology, molecular breeding in crops like bhendi, rice, tapioca, tomato and brinjal to address hitherto unsolved problems in these crops. Rasi Seeds accounted for 29 percent of the total Bt cottonseeds sold in India during the year 2006. Rasi Seeds has a state-of â€“the-art biotechnology laboratory at Attur with facilities for research on DNA fingerprinting, DNA-based genetic purity test, and tissue culture and transformation of different crops. The company has a total staff strength of 420 personnel including PhD, MSc (Ag), BSc (Ag), and diploma holders both in R&D and production sections. The company has a strength of over 12,000 growers for the production of cotton, rice, bajra, maize, vegetables and other crops over an an area of 10,000 acres. Its other facilities include a well maintained research farm of 150 acres, a greenhouse of approximately 55,000 sft, dehumidified and air-conditioned storage for preserving germplasm of breeder seeds, modern high throughput biotech facility for molecular breeding of transgenic crop production. The company has an excellent marketing network all over in India with branches in Andhra Pradesh, Maharashtra, Madhya Pradesh, Punjab, Karnataka Gujarat and Tamil Nadu. It has two production centers, one at Attur and another at Kallakuruchi. The company has latest and sophisticated processing and packing machinery and a research wing to guide and produce high quality seeds. The company has entered contract farming with an ELS cotton hybrid with the objective of "breeding to branding", a new concept developed for the first time in the world. "Bt cotton will continue to be in great demand" - M Ramasami, MD, Rasi Seeds When did you launch Bt cottonseeds in India? And why and when did you enter the Bt cotton area? We launched Bt cottonseeds in India in 2004. RCH 2 Bt is our first Bt cotton hybrid. I decided to enter the area of transgenic Bt cotton during 1997 after I realized that it is beneficial to the Indian farmers in view of reduced pesticide use and ensured yield by way of good protection from cotton bollworm attack. I was confident that environmental pollution could be substantially reduced since cotton is a crop that consumes maximum percentage of pesticides used for agricultural crops. What were the challenges you faced during the launch of the Bt cottonseeds in India? And under which brand name (product name) do you market Bt cottonseeds in India? When it was first introduced, there were mixed feelings among the farmers, as the technology was new to India. Further, there were many apprehensions. We had to do a lot of field demonstrations in all the cotton-growing regions of India to instill confidence among the farmers on the benefits of this wonderful technology. Our first Bt cotton hybrid was RCH 2 Bt. Currently we have 14 Bt cotton hybrids approved by the Government of India for commercial cultivation. What is your current reach and how has the sales been? We have reached 30 percent share on the total sale of Bt cotton during 2006 and our sale is 27 lakh packets of 450 grams each. Which technology do you use? Are you looking at other technologies? We have been using the Bollgard technology developed by Monsanto. Currently I'm taking the initiative to outsource technologies, especially for drought, improving fertilizer use efficiency for viruses like yellow vein mosaic in bhendi, leaf curl virus in cotton and tomato etc. from promising technology providers around the world. How do you see the future for Bt cottonseeds in India and other Bt food and feed crops? Bt cotton will continue to be in great demand in view of the substantial benefits realized by the farmers. The efforts on increasing food production by conventional breeding has reached a plateau and to meet the growing demand for food, production efforts has to go up. The quick possible way is to reduce the loss due to insect pests. I am confident Bt food crops will help us to meet this challenge. I have no idea on the feed crops. Do you see price war in this space with more agribiotech firms (with different technologies) entering the Bt cotton space? Prices are decided by the value the consumer gets out of the technology. Better technology, germplasm and high net return will always fetch higher price. What are the measures taken by your company regarding the availability of legal seeds and to put a check on illegal sale of spurious Bt cottonseeds in the market? We are continuously creating communication to farmers about the benefits of Bt technology under superior germplasm background. We strongly believe that the menace of illegal seeds can be contained only by: Instilling confidence on the quality of seed and adequate supply at reasonable price; And making the farmers to realize that only legal seed suppliers are accountable and reliable. Which are the other GM crops areas that you contemplate to enter? We would be interested in insect resistant rice, brinjal, tomato, bhendi, virus resistant bhendi, tomato and cassava What is the status of your R&D facility for GM crops? Work is in progress to create the facility, sourcing technology, recruiting technical manpower. Do you feel the government should allow GM crops in India? Yes. This is in view of the substantial benefit to the farmers and consumers. ]]> <![CDATA[Collective Expertise]]> https://biospectrumindia.com/news/95/1382/collective-expertise.html https://biospectrumindia.com/news/95/1382/collective-expertise.html Thu, 14 Jun 2007 14:31:00 +0530 New Page 1 Collective Expertise Biocon's integrated business approach coupled with its collective expertise has enabled it to establish a significant presence in the global biopharmaceutical market. Business: Biopharmaceuticals and industrial enzymes CEO: Kiran Mazumdar-Shaw Biotech Revenue: Rs 823 crore Start-up Year: 1978 Address: 20th KM Hosur Road, Electronic City, Bangalore â€“ 560100 Tel.: 91-80-28082808 Fax: 91-80-28523423 Website: www.biocon.com Biocon has reported a total sales of Rs 823 crore for the year ending March 2007 from the sale of biopharmaceuticals and enzymes. As a group, the company ended the year at Rs 990 crore. Revenues from the biopharmaceuticals and enzymes business grew 20 percent to Rs 823 crore from Rs 688 crore contributing 83 percent to operating revenues in FY 2007. Revenues from research services and licensing grew 63 percent to Rs 163 crore from Rs 100 crore, contributing 17 percent to operating revenues in FY 2007. Biocon is today a biopharmaceutical company with strong capabilities in statins, immunosuppressants, recombinant insulin and a wide product range across key therapeutic segments including diabetology, cardiology and oncology. Biocon's R&D initiative began in 1984 with a focus on fermentation-derived microbial enzymes. Subsequently, it extended its research to new domains of knowledge, spanning bioprocess development, gene expression technologies, secondary metabolites, bioconversions and proteomics. Today, it leverages its multiple expertise to leading-edge recombinant biopharmaceuticals and human therapeutics. The invention of the PlaFractor and through it, the ability to pioneer novel production processes for therapeutic molecules, is testimony to Biocon's path-breaking R&D capabilities and exceptional engineering skills. Biocon's subsidiary, Syngene, has entered into research partnership with Bristol Myers Squibb. The new Bristol-Myers Squibb and Syngene research facility is underway. Spread over approximately 150,000 sft, the facility is planned to ultimately house more than 400 scientists to help advance Bristol-Myers Squibb's discovery and early drug development in India. This is expected to significantly increase the scope of Bristol Myers Squibb's existing relationship with Syngene to further develop integrated capabilities in medicinal chemistry, biology, drug metabolism and pharmaceutical development. Through this symbiotic global partnership, Biocon's Syngene will provide research and development services for discovery and early drug development. Biocon is developing Nasulin, an intra-nasal insulin spray with Bentley Pharmaceuticals. The Drugs controller general of India has cleared Nasulin for phase 2 trials on type-2 diabetic patients, a company release said. Biocon's subsidiary, Clinigene International, will conduct and complete clinical trials by the end of the year. Bentley has completed pharmacokinetic clinical studies with Nasulin in India and expects to close a significant portion of the US phase 2 studies by the end of 2007. Nasulin is the second non-injectable insulin that Biocon is working on, besides the oral tablet-form insulin IN 105, which is almost on a parallel track at phase 1C. Both the drugs may be 3-4 years from commercial stage. Biocon and Abu Dhabi's NMC Group signed an MoU to establish a JV to manufacture and market a range of biopharmaceuticals for the GCC region (Gulf Cooperation Council). This landmark agreement between the two companies heralds the region's first foray to develop and market life-saving biopharmaceutical products and will expand Neopharma's (NMC Group) existing portfolio with a range of Biocon's therapeutic products. These products will be in the cardiovascular, diabetes and oncology segments, which represent the fastest growing class of drugs in the $ 5 billion GCC pharmaceutical market. This JV is a key milestone for Biocon's marketing foray in the Gulf. Biocon launched BIOMAb-EGFR, a therapeutic monoclonal antibody-based drug for treating solid tumors of epithelial origin, such as head and neck cancers. The drug is the first of its kind to be clinically developed in India and is the first anti-EGFR humanized monoclonal antibody for cancer to be made available commercially anywhere in the world. The product has shown consistent positive outcome in clinical trials initiated both in India and globally and is being studied in global clinical trials for Colorectal, Lung Cancer, Glioma and Pancreatic cancers. BIOMAb-EGFR is produced at Biocon's state-of-the-art manufacturing facility-Biocon Park. Biocon has also granted an exclusive license to Ferozsons Laboratories for marketing BIOMAb-EGFR in Pakistan. Ferozsons Laboratories is a leading oncology company. Biocon has a pipeline of 12 molecules that could be out-licensed over a period of 12 to 24 months. The company is in an advanced stage of discussion on three molecules. It is keen to out license an oral insulin molecule called IN105 for type II diabetes and potential drug for congestive heart failure. The others range from a monoclonal antibody from a monoclonal antibody for rheumatoid arthritis to a squamous cell antibody for non-Hodgkin's lymphoma. Biocon launched a comprehensive portfolio of renal therapy products which are priced 35 percent lesser than those available in the market. Biocon's nephrology division is committed to finding solutions to kidney disorders using the highest standards of biotherapeutics and will simultaneously strive towards reducing the risks of the disease in the future, through progressive research and innovative therapies. The new immunosuppressant drugs for renal therapy include Ranodapt, Tacrograf, Cyclophil ME, Rapacan and Erypro. Immonusuppressants are medicines that inhibit or prevent the activity of the body's immune system. Its newly carved out nephrology division expects to release more drugs in the market which include certain aspects of kidney related eases. To achieve this end, Biocon will continue to increase investments in the R&D division. Biocon expects to double its R&D spend in 2007-08. "Biocon truly believes that non-injectable insulins will drive the future of diabetes therapy the world over. The company wants to play a big role in the insulin market, currently valued at nearly Rs 300 crore in the country," said Rakesh Bamzai, president, marketing, Biocon. Biocon's new product pipeline includes therapeutic biomolecules ranging from small molecules (e.g., statins, immunosuppressants) to recombinant proteins (human insulin and monoclonal antibodies) derived from microbial and mammalian cell culture based fermentation technologies. ]]> <![CDATA[Vaccine King]]> https://biospectrumindia.com/news/95/1888/vaccine-king.html https://biospectrumindia.com/news/95/1888/vaccine-king.html Thu, 14 Jun 2007 13:19:00 +0530 New Page 1 Vaccine King With a record sales of Rs 950.95 crore in 2006-07, Serum Institute of India continues to be a leader in the vaccines market.   Business: Manufacturing and marketing of vaccines and immuno-biologicals CEO: Dr C S Poonawalla (CMD) Biotech Revenue: Rs 950.95 crore Start-up Year: 1966 Address: 212/2, Hadapsar, Off Soli Poonawalla Road, Pune- 411 028 Tel: 91-20-2699 3900 Fax: 91-20-2699 3921 Website: www.seruminstitute.com   Amidst stiff competition in vaccines market, Serum In- stitute of India Ltd continued its leadership position in the vaccines business with a record sales of Rs 950.95 crore in 2006-07 registering a growth of 35 percent over the previous year's sales revenue of 703 crore. Over 80 percent of its sales are from overseas market with little from the Indian market. Serum Institute supplies vaccines to more than 130 countries across the world and it leads in MMR and Hep B vaccines in India. Its subsidiary company, Serum International, generated Rs 42 crore in 2006-07 against the previous year's sales of Rs 36 crore, registering a growth of over 16 percent. With this, the group turnover of Serum Institute has touched Rs 992.95 crore for 2006-07. During 2005-06, Serum Institute registered a growth of 39.21 percent against the previous year's meager growth of 2.85 percent. The exports turnover in 2005-06 was Rs 550 crore. During 2004-05, Serum Institute of India's sales touched Rs 505 crore as against last year's sales of Rs 491 crore. Serum Institute of India has taken many initiatives during 2006-07. It launched its indigenously developed HIB vaccine. It has a capacity to produce over 100 million doses of the vaccine. Serum Institute will supply this new age vaccine to GAVI (Global Alliance for Vaccines and Immunization), PAHO (Pan American Health Organization) and UNICEF. Dr Cyrus Poonawalla, chairman and managing director, Serum Institute of India, said, "With HIB vaccine, Serum Institute achieves one more milestone in its quest for providing high quality vaccines at affordable prices. Serum Institute is the only indigenous manufacturer of HIB vaccine in India today unlike other vaccine manufacturers who import the bulk. HIB vaccine is fully manufactured in India. Serum Institute has invested significantly in R&D and these efforts are yielding results." Serum Institute will supply the HIB vaccine at a low price compared to the MNC prices. It has established its credentials by providing quality vaccines to global healthcare agencies, thereby reducing mortality rates due to diseases like measles. The vaccine will also be available as SiiHIB Pro. Besides launching HIB vaccine, it picked up a 14 percent stake in Lipoxen PLC, a biopharmaceutical company specializing in the development of differentiated biologicals, vaccines and oncology drugs. Lipoxen has raised $5 million in new funds from the Serum Institute of India through a subscription agreement and associated warrant agreement. "We are excited about our strategic investment in Lipoxen and feel their technology is a key component to our strategy to create high value differentiated biologics and vaccines. Our investment and increased strategic collaboration was prompted by Serum's desire to become a large contributor in the biopharmaceutical world and by the very positive preliminary scientific data," Dr Poonawalla said. Serum Institute has entered into another agreement with Akorn of USA for definitive development and exclusive distribution rights for rabies monoclonal antibody. The term of the agreement is ten years following the first commercial sale of products. As part of the agreement, Serum has agreed to appoint Akorn as the exclusive distributor for rabies monoclonal antibody. In exchange for Akorn receiving exclusive marketing and distribution rights to North, Central, and South America, Akorn has agreed to help fund product development through milestone payments. These milestone payments include the successful completion of Phase I, Phase II, and Phase III clinical trials leading to eventual receipt of CBER approval for a BLA license. BLA approval is targeted to occur in 2012 and Akorn expects to fund these milestone payments with cash flow provided from operations. Serum also granted Akorn the first option right to obtain exclusive marketing rights in North, Central, and South America for a second monoclonal antibody product, Anti-D human monoclonal antibody. Additionally, Serum has granted Akorn the first option right to expand the territory to include Europe in exchange for annual product sales requirements in Europe. Serum Institute is also involved in supporting the development of vaccine critically needed in poorest countries like Africa. It was involved in the Meningitis Vaccine Project (MVP), a partnership between the World Health Organization (WHO) and Seattle-based non-profit, PATH, and has completed the Phase I clinical trial of a new conjugate vaccine against serogroup. The Serum Institute and MVP will now proceed to test the vaccine in Africa where the new vaccine will become part of the public health arsenal. Since the vaccine will be licensed in India, it could also be used in this country, where small outbreaks of serogroup A meningococcal disease occur sporadically. The underlying technology for the new conjugate vaccine was developed by the Centre for Biologics Evaluation and Research of the USFDA. Dr Cyrus Poonawalla said, "We believe in health for all and in reaching out to the poorest countries in the remotest places." Since its inception, Serum Institute has placed great reliance on its R&D function. The generous investment in men, machines and materials yielded rich returns. A distinctly separate autonomous body, Serum Institute of India Research Foundation, was instituted in 1977 with a focus on research in the fields of medical sciences and in natural and applied sciences. The success story of the Foundation includes the pilot production of measles vaccine on human diploid cells; industrial column chromatography and affinity chromatography for separation of immunoglobulins; monitoring of quality of vaccines in the field. Now its endeavor is to improve the health of world's children by preventing diseases through immunization. In this regard it has under taken many R&D initiatives such as development of better adjuvants, heat stable vaccines, DNA rabies vaccines, conjugate vaccines. Besides it has other products in the pipeline like tetravalent DTP- Hib combination vaccine, pentavalent combination vaccine (DTP-HB-Hib) which is the most sought after by GAVI, UNICEF, WHO and World Bank, Lyophilized HDC vaccine, meningococcal A conjugate vaccine and percutaneous BCG vaccine for superficial bladder cancer. Serum Institute has set up the country's first biotech SEZ under the name Serum Bio Pharma Park in Pune during early 2006. The entire project will be completed in phases by 2010 at an estimated cost of Rs 1,200 crore. In the Phase I, it will invest a minimum of Rs 500 crore. About one billion doses of various vaccines are expected to be produced on an annual basis from this SEZ. ]]> <![CDATA[The generics boom]]> https://biospectrumindia.com/news/95/1840/the-generics-boom.html https://biospectrumindia.com/news/95/1840/the-generics-boom.html Thu, 14 Jun 2007 13:13:00 +0530 New Page 1 The generics boom Drugs worth more than $76 billion in sales are set to go "off patent" in the next few years. This amounts to an explosion in the generic drug market size. According to research firm, Research and Markets, the global generic drug market has grown at a rate of 20 percent in 2005; which is four times that of patented drugs and over three times that of pharmaceutical market. It is estimated to grow at a CAGR of 13.62 percent during the five-year period 2006-10.A 2006 report released by Datamonitor, estimated that $160 billion market currently served by blockbuster drugs will open up for the generics players between now and the year 2015. This has opened up enormous opportunities for the generics players in Asia. They are all gearing up to tap the new markets through mergers, acquisitions, and alliances even with their competitors. BioSpectrum brings to you an overview of the generics boom. The rise of generics The deal activity has increased tremendously in the last 12 months as the generics majors prepare to put their best foot forward into the emerging generics market. In early 2006, Indian pharma major, Dr Reddy's Laboratories outbid the world's largest generics company, Teva, to acquire Germany's fourth largest company, Betapharm, for a sum of $570 million. Soon after followed Ranbaxy's acquisition of Romania's largest generics pharma company, Terapia, for a consideration of $324 million. In fact, India-headquartered Ranbaxy, in 2006, executed a record number of eight acquisitions spanning across geographies. Success stories from China include Zhejiang Huahai, a company that makes blood pressure drug Irbesartan, a generic version of Avapro (Bristol Myers Squibb) Harbin Pharma that makes Penicillin and Cephalosporin, and Hisun Pharma that makes Atorvastatin, a generic version of Pfizer's cholesterol lowering drug Lipitor. Consider this. At the Generics Congress held recently in Singapore, Dr Jia-Li Lou, Chairman and CEO of Hisun Pharma said that the Chinese pharma sector is growing at almost 20 percent and is valued at $65 billion. Even Japan, the world's second largest pharma market is ready to embrace the generics players. Teva and Sandoz and Indian players like Biocon have already reached Japan. India's Lupin is looking for acquisitions to expand its presence in the $80 billion Japanese market. Japanese generics companies are also preparing themselves for the sales surge as the government is changing policies and taking up awareness campaigns to boost generics. The Japanese govern ment is working to bring legislative changes to allow foreign investors with an aim to bring down the cost of drugs in the country. China aims for center stage China's biogenerics industry has experienced rapid expansion and will continue to have steady growth in future years. Analysts who are tracking China are confident of its potential as a generics powerhouse. Ms Eliza Yibing Zhou, project director for research programs in China and India for Rockville, Marylandâ€“based business consultancy BioPlan Associates says China is a country with a large market potential and solid foundation to produce biogenerics and it will play an important role in the world's biogenerics market in the future. Statistics show that generic drugs dominate the Chinese pharmaceutical market; 95 percent of Chinese pharmaceutical products are generic The market share of innovative drugs (including proprietary drugs) has shown an increase: rising from 17 percent in 1997 to 20 percent in 2003. The North China Pharmaceutical group is one of the first companies in China that started research on modern biotechnology and formed the system for developing generic drug involving new products R&D, pilot production and commercial production. It produces over 430 kinds of antibiotics, semi-synthetic antibiotics, and pharma intermediates. Some other success stories from China are Zhejiang Huahai, a company that makes blood pressure drug Irbesartan, a generic version of Avapro (Bristol Myers Squibb) Harbin Pharma that makes Penicillin and Cephalosporin, and Hisun Pharma that makes Atorvastatin, a generic version of Pfizer's cholesterol lowering drug Lipitor. At the Generics Congress held recently in Singapore, Dr Jia-Li Lou, Chairman and CEO of Hisun Pharma said that the Chinese pharma sector is growing at almost 20 percent and is valued at $65 billion. "The state and local governments are making sustained efforts to encourage the expansion of the biogenerics industry and enhance IP protection for both domestic and foreign biologics," Dr Lou said. With governments and public opinion on their side, this is just the right time for Asian players to consolidate their presence in the major markets and meet the unmet needs of the millions of patients around the world. Industry estimates emphasize that in the next 10 years the complexion of this market segment is going to change dramatically. There will be consolidation in the industry, stronger players will emerge, and by 2015 it is likely that you will see a couple of Asian companies break into the top 10 list of global generic players. For now, from Asia, Ranbaxy rules the roost. The frontrunner from Asia The only Asian MNC to be counted in the top 10-list of generic drug makers, India-headquartered Ranbaxy is headed by its young CEO, Mr Malvinder Mohan Singh. Better-known as MMS to his friends and colleagues, Singh has been instrumental in turning around Ranbaxy after its pitiable performance in FY 2004-05. That was the time the company was facing intense pricing pressures in the US market, which also happened to be its largest market. That was just about the time Singh took over reins of the company. According to Singh, for Ranbaxy the journey from the very start, in the early 70s, has been ambitious. "Ranbaxy was the first Indian company to go global and that was way before 'Indian Inc' as such came into existence," he recounted. The story of Ranbaxy is that of a very old company keeping pace with times and reinventing itself time and again as it went along. Today, Ranbaxy boasts of manufacturing facilities in nine countries and ground presence in 49 countries. Its products are being sold in over 125 countries. Gunning for a spot among top five, it is aiming at $5 billion in revenues by 2012. In 2006, the company successfully closed eight acquisition deals across geographies spanning US, Europe, Africa and Asia. For acquisitions, Ranbaxy works within a very well defined financial framework, which is why the company backed out of acquiring Merck's generic drug business, informed Singh. "Along with being a good strategic fit the acquisition target should also add to the economic value," he elaborated emphasizing that Ranbaxy will actively pursue both organic and inorganic growth to reach its target revenue of $5 billion. In the year that went by, the company turned its attention to focus on emerging markets. In 2006, Ranbaxy strengthened its ground presence in Europe market. The blueprint included an equity stake in Terapia. As for the high selling products-in-the-making at Ranbaxy, there is a huge list but Singh is banking heavy on Ranbaxy's Atorvastatin launch in the US scheduled for 2010. He expects the huge financial returns from there will help him take Ranbaxy to another level of growth. Ranbaxy is set to close 2007 with $2 billion in revenues and Singh sees it happening as per plan. He is keeping the pace, striving to move his company up the value chain with a two-pronged agenda: One, attaining & retaining strong leadership in the generic space and two, leveraging IP that Ranbaxy is creating via innovation and commercializing it. The company is actively expanding in new drug discovery and novel drug discovery systems. The list of Indian companies riding the generics wave runs long. Led by Ranbaxy the list includes Cipla, Dr Reddy's Laboratories, Sun pharmaceuticals, Nicholas Piramal, Zydus Cadila, Glenmark, Orchid Chemicals and Wockhardt among others. Each of these companies are well-entrenched in their respective segments. For instance, Cipla supplies its cheap anti-AIDS drug to more than 35 countries, mainly in Africa. According to industry estimates Indian drug-makers are expected to acquire a 33 percent share of the global generic market in the next two years as against the current four percent market share.   ]]> <![CDATA[Aging Will Be Controlled by 2030]]> https://biospectrumindia.com/news/95/2875/aging-will-be-controlled-by-2030.html https://biospectrumindia.com/news/95/2875/aging-will-be-controlled-by-2030.html Thu, 14 Jun 2007 12:54:00 +0530 New Page 1 Aging Will Be Controlled by 2030 Experts at BIO point out that aging will be controlled by 2030 and the cost of making products will become faster and less expensive. The final keynote session at BIO International Convention was on "A Hopeful Future: Gaining the Edge with Biotechnology." The session moderated by BIO chief Greenwood featured a high power panel of Robert S Langer of the Massachusetts Institute of Technology (MIT), Craig C Mello, of the University of Massachusetts Medical School, author Virginia Postrel and Dr Phillip A Sharp of MIT. The panelists discussed their visions of the biotechnology industry over the next 10 to 20 years. They concluded that in the future the drug discovery will become faster and less expensive than what it is today. Clinical testing prior to commercialization, however, is likely to remain expensive. Sharp advised that the United States has no monopoly on biotech. "There is science in Europe, Asia and elsewhere. I see US having increasing competition. Biotech is something we have to keep competing at," he said. Mello and Postrel agreed that the cost of not treating disease has to be examined, perhaps as closely as the costs of treatment are examined today. Drug development costs, they said, should be viewed relative to the economic benefit of a healthy society. Here are some of the responses by the panel to a few important questions posed by Greenwood. Has biotech arrived? We are there. We are seeing the introduction of the first type of drugs. A decade ago, we did not know the role of RNAi. Now one is seeing nanotechnology used for newer applications. Bioindustrial applications are gaining momentum. Biotechnology is a fabulous and heartwarming industry. We need to treat the sick, feed people, and create alternative energy. Our heart and soul are the fragile start ups. Our success will depend on holding each other by strong ethics and through innovations. It is a social obligation to the society. But the society in return should live up to the contract. Both parties need to work hand in hand and in a balanced way. We have to step up our efforts to meet the challenges. One should remember that the future is uneven and distributed. Any predications on health care in 2030? We can control ageing. The newest breakthrough is in controlling ageing. David Sinclair's team at Harvard Medical School is focused on finding small molecules and genes that can delay or prevent diseases caused by aging. His lab is one of the few in the world that studies a variety of different organisms--baker's yeast, nematode worms, fruit flies and mice--to understand aging. In 1997, Sinclair's research at MIT identified the discovery of the cause of aging in yeast, a first for any species. In May 2003, Sinclair's laboratory reported the discovery of a conserved "master regulatory gene" for aging in yeast that was published in the journal Nature. Toilets will be monitoring metabolites combined with genomics. As our knowledge of the human genome increases several genes with variants which affect drug metabolism will be found. Gene therapy, somatic cell therapy, and tissue engineering are expected to have a major impact on public health. The idea would be to create new skin, bladder, pancreas, and so on. Human genetics is going to be very fantastic. Will the cost of making products reduce? Every disease has a cost to it. And the any technology that is developed will focus on reducing the cost of treatment. One of the reasons that God made engineers is to reduce cost. We have to innovate. That is why RNAi is such a good development. Costs will decrease and bring benefit to the society. We need to focus on collaborative work and see the cost from a holistic system. How do you see the biotech being developed globally? We (USA) do not have a monopoly of any aspect of biotech and bioscience. We are leading but we have to be competing. The reverse brain drain is happening in China. Mexico is training more engineers than the US. This is a major challenge in the US. What are some of the things that people do not know? The studies of the brain are increasing. The info on 3D interaction of DNA-RNA-protein. This info can be generated from one generation to the next.   ]]> <![CDATA[Not Terrorism, but Finding Cures Is the Top National Issue]]> https://biospectrumindia.com/news/95/6701/not-terrorism-but-finding-cures-is-the-top-national-issue.html https://biospectrumindia.com/news/95/6701/not-terrorism-but-finding-cures-is-the-top-national-issue.html Thu, 14 Jun 2007 12:27:00 +0530 New Page 1 Not Terrorism, but Finding Cures Is the Top National Issue Say American voters in a survey conducted by nationally recognized Republican and Democratic strategy firms-Public Opinion Strategies and Peter D Hart Research Associates The Americans rate the importance of finding cures to diseases as top national issue, much ahead of popularly known issues like fighting terrorism or dealing with illegal immigration according to the surveys conducted by Public Opinion Strategies and Peter D Hart Research Associates in the US on the outlook of the biotechnology, which was announced during the opening day of 2007 BIO International Convention in Boston. Key Highlights of the Surveys Industry Leader's Outlook on the Biotechnology Industry Industry leaders are strongly optimistic about the future of the biotech industry and will continue to develop new therapeutics and products (79%). The pace of discovery in the next 5-10 years will be faster in the next decade than that is today (56%) Industry leaders perceive "regulatory burdens" and "political interference" as the most difficult challenges facing them in the next 5-10 years. Say the federal government has had a negative impact on the biotechnology industry (56%). Industry leaders believe avoiding price controls is the most helpful action the government could take (71%) Public's Outlook on the Biotechnology Industry The image of the biotech companies is strong and stable (86%) Patient access for new biotech treatment in public healthcare is a overwhelmingly viewed as positive development (80%) Almost three-quarters of voters agree the growth of alternative fuels is a positive development (73%). By a margin of two-to-one, voters believe embryonic stem cell research is a positive development (63%). Voters were split on how they perceived the development of GM crops Biotech Goals Industry leaders and voters were asked to review seven goals the biotech industry is trying to reach in the next 10-15 years. Industry leaders were asked to rate each on how likely the biotech industry would accomplish the goal and voters were asked to prioritize the importance of each goal. Industry leaders and voters agree on the likelihood and importance of three of these goals. Finding cures to the serious diseases Clean technologies to reduce pollution Green drug factories This is the most important revelation that bestows a higher level of expectation from the consumers, policy makers and the industry alike. Further, the Americans expressed majority support for full patient access to new biotech treatments, development of alternative fuels, and embryonic stem cell research as positive developments in the biotech industry. The surveys were conducted during the third and fourth week of April this year. The surveys not only took into account the opinion of the industry leaders but also the general public. Further, the two surveys were conducted jointly by the nationally recognized Republican and Democratic strategy firms Public Opinion Strategies and Peter D Hart Research Associates, which compared the views of nationwide voters and senior-level biotechnology industry executives on a number of issues, including health care, the environment, alternative fuels and stem cell research. While a national telephone survey of 800 registered voters was conducted during April 17-19, 2007 to seek the responses from the voters, a national Internet survey of 252 biotechnology industry leaders was conducted during April 11-24, 2007 to get the feedback from the industry leaders. Commenting on the findings of the surveys, Jim Greenwood, president and CEO, BIO, said, "There is a lot for all of us to learn. I am heartened by the enormous public support for the current direction of the biotechnology industry. The results of this poll show strong public support for our industry and provide a helpful context as we work throughout the year to ensure a positive policy environment and a familiarity among the general public that allows us to continue to move towards our vision of a better future." Top 10 Issues for the American Voters 1. Finding cures to help patients suffering from serious diseases (78%) 2. Improving the quality of public education (78%) 3. Improving the economy and creating good paying jobs (77%) 4. Combating terrorism in the US and overseas (71%) 5. Developing alternative energy (71%) 6. Securing borders and addressing illegal immigration (68%) 7. Protecting the environment from pollution and global warming (61%) 8. Reducing taxes (51%) 9. Increasing food production and enhancing nutritional value (48%) 10. Improving the nation's roads and highways (37%) Note: Figures in brackets are percentage of voters The survey findings clearly demonstrate that the voters and the biotechnology industry share a similar optimistic vision of the future--a vision of a world with cures and treatments for the most devastating diseases, a green, renewable supply of alternative fuels, and a cleaner environment. The groups of respondents-industry and general public--were optimistic that cures to major diseases will be found within the next 10-15 years. According to the survey results, industry leaders and voters share high levels of optimism about the potential for finding cures for serious diseases and have similar perspectives on the likelihood and importance of finding cures, developing clean technologies to reduce pollution, and creating "green drug factories." In fact the voters are more optimistic on the energy independence deliverables than the industry itself. Only 47 percent of the voters thought GM crops are a "positive development" because they have dramatically increased food production and enhanced its nutritional value, alleviating the problem of hunger and malnutrition in the poorest countries of the world and these crops have reduced the reliance on chemical pesticides. Almost 43 percent of the voters felt GM crops are a "troubling development" as there have not been enough tests to confirm the risks and overall safety. ]]> <![CDATA[Global Biotech $70 Billion and Counting]]> https://biospectrumindia.com/news/95/2438/global-biotech-70-billion-and-counting.html https://biospectrumindia.com/news/95/2438/global-biotech-70-billion-and-counting.html Thu, 14 Jun 2007 12:09:00 +0530 New Page 1 Global Biotech $70 Billion and Counting Industry all set to cross $100 billion in revenues by 2010, forecasts Ernst & Young According to Ernst & Young's 2007 Global Biotechnology Report, released at BIO 2007 in Boston, the biotech industry made historic progress with strong product pipelines and product successes, record-breaking financing totals, unprecedented deal activity and impressive financial results. This trend is reflected in the strong financial performance of the global biotech industry. The global biotech revenues of public listed companies in 2006 grew to $73.5 billion, recording a 14 percent growth over that in 2005 ($64 billion). Further, according to the report, all the leading regions of the world recorded double-digit growth. The US and Europe recorded 13 percent growth each and Canada registered 22 percent. "The industry in the US has never been stronger and we're seeing its success story spreading to other parts of the world-particularly Europe," said Glen Giovannetti, Ernst & Young's Global Biotechnology Leader. "Time will determine whether these trends will be sustained, but there's reason for optimism. Innovation is being rewarded with record revenues and unprecedented premiums in M&A transactions." Success on Most Parameters The global biotechnology industry showed robust growth in all respects in 2006. Deal values soared with alliances involving US companies totaling $23 billion-an all-time record-while high premiums (the difference between the price per share paid by a buyer and the company's share price before the deal was announced) drove the value of mergers and acquisitions (M&A) to the second-highest level in the industry's history. Capital raised by the world's biotechnology companies grew by a massive 42 percent, to $27.9 billion. Venture capital (VC) reached $5.4 billion, an all-time high. Net losses of publicly traded companies fell by 37 percent in Europe and 43 percent in Canada, creating momentum toward profitability. While the US sector saw increased net losses, this was primarily due to large transaction-related charges in a year of unprecedented deal activity; in the absence of these, the US industry would have been profitable in aggregate for the first time, and the global industry would have had its lowest net-loss ever. The US product approvals increased from 33 in 2005 to 36 in 2006. New drug application (NDA) and biologic license application (BLA) approvals grew from 21 to 25. In Europe, product pipelines of public companies grew significantly. The Year of the Deal Intense competition, particularly among pharmaceutical buyers, created a robust deal environment in 2006. The average premium in M&A transactions with values over $500 million increased to 60 percent in 2006, more than twice the average M&A premium from 2003 to 2005. Several companies in the US were acquired for premiums in the 50 percent range, with some crossing the 100 percent threshold. In a reversal of recent trends, pharmaceutical buyers gravitated towards early-stage platforms and technologies. "In many ways, 2006 was the year of the deal; this is all the more remarkable because there was no one deal of the year," said Giovannetti. "In prior years, high deal-value totals were typically driven by a single mega deal, but in 2006, we now have widespread recognition among buyers of the potential value in biotech's platforms and pipelines. That's remarkable, and a testament to the tremendous innovation of the global drug development industry." Data were generally derived from year-end information (31 December). 2006 data are estimates based on January-September quarterly filings and preliminary annual financial performance data for some companies. 2006 employee data are obtained from SEC filings at time of publishing, and include a combination employee data of 2005 and 2006. The 2005 estimates have been revised for compatibility with 2006 data. Numbers may appear inconsistent because of rounding US Approaches Profitability The US had another strong year for product approvals with 36, including 25 NDAs and BLAs. This compares favorably with 2005, when the industry secured 33 approvals, including 21 NDAs and BLAs. Raised capital increased by 38 percent, fueled by some of the largest financings in industry history. Revenue grew by 13 percent among public and private biotech companies to $59 billion, and the industry made a truly historic move toward profitability. In the absence of over $4 billion in acquired in-process R&D charges related to the year's unprecedented deal activity, the US publicly-traded sector would have shown an aggregate net profit, for the first time in its history. Notably, the largest revenue growth companies in the US included "mid-tier" firms with recent product launches and rapidly growing sales. "We predicted profitability in the US industry before the end of the decade," said Mike Hildreth, Americas Biotechnology Leader, Ernst & Young. "Only a strong deal year with high charges for in-process research and development kept the industry from reaching that goal this year." Sustained Progress in European Recovery The European biotech sector sustained the recovery it had begun in 2005, with revenue growth of 13 percent-more than twice the 2005 growth rate of six percent-contributing to revenues (for public and private biotech companies) of $16.6 billion. The year 2006 marks a four-year turnaround, from the 12 percent revenue decline recorded in 2003. Financing increased by a robust 45 percent to reach $5.9 billion. VC financings reached an all-time high of $1.9 billion. The pipelines of publicly traded companies grew by an impressive 30 percent, bringing the overall pipeline to almost 700 compounds, plus 27 in registration and awaiting regulatory approval. In addition, Europe's privately held biotech companies have nearly 800 compounds in their pipelines, and 12 compounds in registration. "Last year, there was cautious optimism in the European biotech industry-as the sector emerged from a prolonged period of restructuring," said Siegfried Bialojan, Germany Biotechnology Leader, Ernst & Young. "This year double-digit revenue growth and sustained success across multiple measures prove Europe's biotech sector has bounced back." Emerging Asia-Pacific In Asia-Pacific, governments and companies are moving aggressively to make the transition from competing on cost to developing homegrown innovative pipelines. Businesses are adopting creative models to overcome capital constraints and other hurdles. Firms are reinvesting revenues from services to develop innovative pipelines, and are entering deals to accelerate commercialization efforts, drive economies of scale and increase global competitiveness. Conglomerates are entering the fray, making investments in the growing sector. "Asian biotechnology companies face critical challenges in their efforts to accelerate the transition to become enterprises driven by research and development," said Utkarsh Palnitkar, India Biotechnology Leader, Ernst & Young. "Companies are leveraging the Asian advantage in bio-manufacturing and the contract services arena and utilizing them to drive the growth story in drug discovery and research." Global CEO Insights With the biotech industry maturing in more regions, an increasing number of companies will have to deal with the challenges of success. This year's report features results of an Ernst & Young survey of over 400 biotechnology CEOs, at small, mid-sized and large biotech companies. According to the report, some of the fastest growing challenges facing their companies are issues facing maturing companies: ensuring regulatory compliance for sales forces, dealing with pricing pressures, expanding globally, and managing global operations. Survey respondents also were resoundingly optimistic. Ninety-four percent of respondents indicated they plan to hire new talent in the next two years, and 68 percent indicated plans to introduce new products within two years. These challenges of success will drive even more deal activity in the years ahead, according to survey respondents: Ninety-nine percent of American CEOs and 87 percent of European CEOs plan to enter into deals in the next two years, with "sales and marketing assistance" being the most popular reason for alliances; and Fifty-two percent of CEOs plan to partner to bring new products to market, up from 29 percent of products that are currently marketed with the help of partners Despite these challenges, the biotechnology sector still holds great promise for innovative companies and is comfortably on track to become a $100-billion revenue industry before the end of the decade, predicts the report. New Page 2 2006 data were converted to US$ using an exchange rate of 1.13 (Canadian per US$), except market capitalization, which was converted using an exchange rate of 1.17. Data for 2005 were converted to US$ using an exchange rate of 1.21, except market capitalization, which was converted using an exchange rate of 1.17. When stated in Canadian dollars, revenues grew by 15%, and net loss fell by 47%. 2005 numbers have been restated to reflect full-year results, since estimates in Beyond Borders 2006 included some estimation of fourth quarter results. 2005 net income is affected by QLT's large fourth-quarter loss due to a $410.5 million non-cash charge for impairment of goodwill and other intangible assets resulting from its acquisition of Atrix Laboratories. Numbers may appear inconsistent because of rounding   The 2006 public data are estimates, mostly based on January-September 2006 quarterly filings and preliminary 2006 annual financial performance data for some companies. The 2005 estimates have been revised for compatibility with 2006 data. Numbers may appear inconsistent because of rounding   ]]> <![CDATA[Big Pharma and Big Biotech Will Fight To Accelerate Products]]> https://biospectrumindia.com/news/95/2852/big-pharma-and-big-biotech-will-fight-to-accelerate-products.html https://biospectrumindia.com/news/95/2852/big-pharma-and-big-biotech-will-fight-to-accelerate-products.html Thu, 14 Jun 2007 11:51:00 +0530 New Page 1 Big Pharma and Big Biotech Will Fight To Accelerate Products Predicts the biotechnology industry's leading expert and visionary, G Steven Burrill, CEO, Burrill & Company In his keynote speech at BIO 2007, in Boston, Massachusetts on May 7, 2007, G Steven Burrill, CEO, Burrill & Company, described how biotechnology is transforming into a massive global enterprise. He touched upon the events that occurred during the past 12 months and presented data on the financial performance of the industry. Burrill pointed out that the global biotech industry is "transforming". It's moving away from chemistry to biochemistry; from one-size-fits-all drugs to personalized medicine; from "aging just happens" to "aging is optional". Therapeutics, diagnostics, and devices are becoming "theranostics"; the focus is shifting from treating sickness to preventing sickness; and it's no more food for survival, but food for health. While all this is happening on the technology front, a global transformation is underway in the industry too. With over 5,000 companies, biotech today is truly a global industry. Despite changes in the industry leadership, the major companies of 20 years ago are still important. According to Burrill, even the smallest biotech company is a global player from Day One. "The global transformation that is a central theme in our book, Biotech 2007, does not just refer to geography. It is occurring pan-industry and across technology and having an impact on the innovation that results," observed Burrill. "We have begun to understand disease 'globally', that is, from a systems point of view, from gene or SNP to protein to networks to disease. In parallel, and conversely, the notion of 'one size fits all' is being replaced by medicine targeting the individual. The central tenet on which a huge biopharmaceutical industry has been built has to adjust to a new and evolving personalized medicine world." "The industry is over 30 years old and is generating over $85 billion in revenues. There are 5,000 companies worldwide, 600 of which are public companies. The life sciences have a strong performance record, even in difficult economic and political times and have outperformed Dow and NASDAQ. There are over 100 products on the market (many of them are $1 billion drugs). Further, 350 biotech drugs are in late-stage clinical trials (strong pipeline). Agbio products are now grown on 200 million acres worldwide and it is growing at 20 percent per year. The market cap is going in the right direction with the figure touching $550 billion," said Burrill, giving the current status of the biotech sector.       Building on these statistics, he provided predictions for the rest of the year and his visions for the future. Some of the key transformations that he identified included: From waiting for disease to occur to developing predictive models From treating sickness to preventing disease From "one size fits all" drugs to targeted therapies and personalized medicine From regulatory barriers to harmonization From patents to "barriers to entry" From concern about GMOs to substantial increases in global acreage From crops for food to crops for fuel From dwindling fossil fuels to renewable bio-energy From expensive unavailable capital locally to global arbitrage From local companies to global companies Burrill predicted heated debates on healthcare in 2007. He also predicted a continued increase in sales of products. While the industry would continue to live in a world of stricter regulations, according to Burrill, the products will come. He foresaw that big pharma and big biotechs would fight to accelerate products.   ]]> <![CDATA[Public Support For Biotech on the Rise]]> https://biospectrumindia.com/news/95/1192/public-support-for-biotech-on-the-rise.html https://biospectrumindia.com/news/95/1192/public-support-for-biotech-on-the-rise.html Thu, 14 Jun 2007 11:46:00 +0530 New Page 1 Public Support For Biotech on the Rise BIO 2007 International Convention reflects stable and stronger image for biotech This year's annual BIO International Convention, held during May 6-9, 2007, surpassed all the records. The BIO International Convention, produced by the Biotechnology Industry Organization (BIO), drew a record 22,366 attendees. With representatives from 48 states and 64 countries, the number of attendees saw almost a 15 percent increase compared to that during the previous year's BIO in Chicago. One-third of attendees came from outside the United States. This year's theme was "New Ideas, Bold Ventures, Global Benefits". This perspective was symbolized by a large globe, about 20-25 feet in diameter, at the entrance of the conference center to highlight biotech efforts in areas around the world. "The host cities generally desire to be recognized as major biotech hubs. But this conference has taken a much broader view, since Boston doesn't really need anything to prove," said BIO president and CEO Jim Greenwood. Boston area is home to two of the world's largest biotechs--Genzyme and Biogen Idec. "The 2007 BIO International Convention was a phenomenal success. With nearly 30 percent of our attendees coming from outside of the United States and pavilions from 39 countries or geographic regions, it truly was the global event for biotechnology," added Jim Greenwood. Further, the BIO Exhibition featured the largest gathering of biotech exhibitors in history, with more than 1,900 companies and 60 domestic, country and regional pavilions representing every aspect of the biotechnology industry. The BIO Business Forum also set records for attendance and partnering meetings. More than 6,000 attendees representing 1,503 companies participated in the Forum and held 12,103 partnering meetings. The event marked keynote addresses from Michael J Fox, founder of the Michael J Fox Foundation for Parkinson's Research, and Her Majesty Queen Noor of Jordan. Fox called the biotechnology industry to continue to innovate and accelerate the translation of basic science into improved therapies for patients. Queen Noor discussed the opportunities presented by biotechnology to address global health and poverty issues. The final keynote session focused on "A Hopeful Future: Gaining the Edge with Biotechnology." Greenwood moderated a panel featuring Robert S Langer of the Massachusetts Institute of Technology (MIT), Craig C Mello, PhD, of the University of Massachusetts Medical School, author Virginia Postrel and Dr Phillip A Sharp of MIT. The panelists discussed their visions of the biotechnology industry over the next 10 to 20 years. BioSpectrum presents some of the trends that were discussed at BIO 2007 in the next few pages. Ch. Srinivas Rao in Boston ]]> <![CDATA[Biotech Rumblings]]> https://biospectrumindia.com/news/95/2658/biotech-rumblings.html https://biospectrumindia.com/news/95/2658/biotech-rumblings.html Mon, 07 May 2007 15:18:00 +0530 New Page 1 Biotech Rumblings By every yardstick, the Indian biotech industry is growing at a healthy phase. There is no doubt about this. To support this growing industry, many related sectors have emerged in recent years. Biotech education is one such sector which has expanded its size and scope phenomenally in the last five years. However, the biotech education sector is developing a love-hate relationship with the fledgling biotech industry. Almost every week, I am in different corners of the country interacting with biotech educators, students and teachers. Whether it is Patiala in Punjab in the northern part of the country or at Sathyamangalam in Tamil Nadu's southwestern corner, the industry-academia debate is conducted on predicted lines. All the students want a job in biotech companies and also demand why they don't get the phenomenal salary packages their friends in information technology courses grab without any sweat. On the other hand, industry leaders are dismayed by the quality of the talent pools that come out of the 300 plus institutions providing B.Tech and other related biotech courses. The CEO of a hotshot company lamented to me that his team had to check out over 100 candidates recently just to hire one. Most other CEOs too have similar experiences. The nation seems to be on the verge of producing far too many biotech graduates than required at least in the short run. This is happening because every third engineering college in the country has started a B.Tech (biotech) course and these courses are approved by various agencies which are not really in touch with the movers and shakers of the biotech industry. The industry leaders themselves are struggling to establish their business braving a variety of adverse conditions, including business risk. The academic community is not fully in sync with the demands of this fledgling industry which is trying to establish itself in a very short time and hence their expectations of top class collaborations with companies is not taking place. What is the solution? BioSpectrum has taken the lead to provide the neutral platform for different stakeholders of biotech to come together to meet and understand each other's requirements find a common way out of the mess. The dialogue has to go on at different levels and at multiple locations. Industry will surely require a lot of human resources in the near future and so we should look at the educational entrepreneurs and the students who have placed their bets on biotechnology sympathetically and help them in many ways. Otherwise, a talent crunch will slow down the growth of the industry when it is ready to take off. Meanwhile, the nation has honored Geneticist MS Swaminathan by making him a Member of Parliament. The presence of people like Swaminathan whose tireless contributions in the public domain for the last 50 years will actually enhance the status of the upper house of Parliament (Rajya Sabha). It is indeed an honor to the biotech community that President Kalam chose to nominate Swaminathan in the special category reserved for experts like him. We are all proud of the fact that the First BioSpectrum Life Time Achievement Awardee will add yet another cap to his illustrious career to further the cause of Indian farmers and the biotechnology sector. Now only two other honors await him: a Bharat Ratna and selection as the President of India. The 5th BioSpectrum-ABLE Survey process has started and the questionnaire would reach you all before you get this copy of the magazine. This year, the Indian Institute of Management, Bangalore (IIM-B) too has joined to the survey process to assess the impact of strategic alliances, and mergers and acquisitions on the industry. We look forward to an overwhelming response to the survey this time too. <sureshn@cybermedia.co.in>     ]]> <![CDATA["Finance professionals, process engineers and marketing experts are in demand"]]> https://biospectrumindia.com/news/95/2696/finance-professionals-process-engineers-and-marketing-experts-are-in-demand.html https://biospectrumindia.com/news/95/2696/finance-professionals-process-engineers-and-marketing-experts-are-in-demand.html Mon, 07 May 2007 15:12:00 +0530 New Page 1 "Finance professionals, process engineers and marketing experts are in demand" Syngenta Crop Protection AG is a large global agribusiness which markets seeds and crop protection products. Involved in biotechnology and genomic research, the company is a leader in crop protection, and ranks third in total sales in the commercial agricultural seeds market. During his recent visit to Switzerland, E Abraham Mathew, Chief Editor of BioSpectrum, had a chat with Dr Sasank S Mohanty, head of GISS Process Improvement-/Program Management Office, Syngenta Crop Protection AG. Some excerpts: What prompted you to pursue your college education in Switzerland (University of Zurich)? It was my aim to study medicine in Switzerland. Swiss universities hold a good reputation in the field of medicine apart from which education is more affordable. Ample funding for research and state-of-the-art infrastructure were other criteria which attracted me to come to Zurich. Was it difficult to adjust to the culture, language, climate etc.? For me personally, it was not so difficult to adjust as I was young and quite flexible to change besides being open to different ways of thinking. However, I picked up the German language in three months and I prefer cold weather to extremely hot temperatures. Last but not least, I instantly fell in love with the Swiss mountains. After college, what made you decide to work in Switzerland? I had decided to study medicine in Switzerland and return to my home country. As I didn't get a chance to study medicine (due to a change in the university policy which barred foreign students from entering medicine), I studied chemistry. After doing my doctorate, I did not see much possibility of doing research in India. Simultaneously, I got good offers in the Swiss pharmaceutical industry and decided to take up one of those. In which areas within the life sciences industry, are the chances of employment the brightest for an Indian professional or student? Switzerland is known for its pharmaceutical research and industries. Currently, the main hot areas are nanotechnology, bioinformatics and system biology. Besides finance professionals, process engineers and marketing experts are also in demand. What are the pre-requisites for an Indian to gain employment in the life sciences sector in Switzerland? Solid theoretical and technical education; ability to adjust to a new culture; and language skills (English and German or French). The Indian community in Switzerland is relatively small (over 7,000). Is there ample opportunity to socialize with other Indians and celebrate festivals etc.? There are several Indian associations like in Zurich, Basel, Bern, Geneva etc. and one should look for opportunities of networking with other Indians. Recently a few Hindu temples have been established around big cities by Sri Lankan Tamil communities. What would be your advice for young aspiring Indians who want to move to Switzerland or places in Europe? There are a lot of opportunities here. Qualified people are always sought after. Learning German or French would be advisable in order to assimilate into the society.   Here are some important links for the readers: http://www.swissbiotech.org and https://www.eurobiojobs.org E Abraham Mathew   ]]> <![CDATA[BIO expresses concerns regarding new patent reform legislation]]> https://biospectrumindia.com/news/95/1312/bio-expresses-concerns-regarding-new-patent-reform-legislation.html https://biospectrumindia.com/news/95/1312/bio-expresses-concerns-regarding-new-patent-reform-legislation.html Mon, 07 May 2007 15:00:00 +0530 New Page 1 BIO expresses concerns regarding new patent reform legislation Biotechnology Industry Organization (BIO) welcoming the efforts by Senators Leahy and Hatch and Congressmen Berman and Smith to make improvements to the US patent system noted, " Unfortunately, the 'Patent Reform Act of 2007,' as introduced on April 18, 2007, also contains provisions that will weaken the enforceability of validly issued patents, and fails to include necessary reforms to make the patent system more objective and efficient. " In a statement, Jim Greenwood, president, BIO said, "The Bill threatens the ability of biotechnology companies and researchers to find and develop innovative treatments for some of the world's most deadly diseases, such as cancer, heart disease, Alzheimer's, Parkinson's and HIV/AIDS, as well as new solutions to address critical agricultural and environmental challenges facing the global community. He further said, "The Patent Reform Act of 2007 would create a new post-grant opposition system, under which a patent is given no presumption of validity and could be broadly challenged administratively throughout its term -even years after the patentee and the public have come to rely on it, and years after biotech companies have invested hundreds of millions of dollars to bring a patented invention through clinical trials and regulatory approval. Under such a scheme, patents will have less value and investment predicated upon them will diminish." Source: www.bio.org   BIO's key principles on follow-on biologics Jim Greenwood "In order to ensure that new pioneer biotechnology products continue to reach patients and physicians, any statutory pathway for the approval of follow-on biologics must protect patient safety and preserve incentives to innovate," said Jim Greenwood, president and CEO, Biotechnology Industry Organization (BIO). Hence BIO has come out with key principles for legislators. The principles include: ensure patient safety, recognize scientific differences between drugs and biologics, maintain the physician-patient relationship, preserve incentives for innovation, ensure transparent statutory and regulatory processes and continue to prioritize FDA review and approval of new therapies and cures. Greenwood reiterated that the need for Congress to consider a pathway for approving follow-on biologics independent of the legislation reauthorizing the Prescription Drug User Fee Act (PDUFA). "Before a framework for follow-on biologics can be established, Congress must carefully consider and resolve complex scientific, legal, and economic issues. Meanwhile, it is important that Congress complete the PDUFA reauthorization in a timely manner. We believe that attaching follow-on biologics legislation to PDUFA would jeopardize reauthorization of the user fee program to the detriment of patients waiting for new therapies, FDA's internal scientific capabilities, and biomedical innovation," said Greenwood. Source: www.bio.org   Innovative therapies will have minimal impact on healthcare costs: study The widening use of new, innovative biopharmaceutical treatments for diseases such as cancer, multiple sclerosis and heart disease, will have a limited impact on healthcare costs for private healthcare payers over the next several years, according to an independent study released by the Biotechnology Industry Organization (BIO). The study, prepared by the international actuarial firm Milliman, Inc. and titled Realizing the Value of FDA-Approved Therapies, found new innovative therapies, including both new drugs and biologics, will add one percent to the healthcare costs covered by private commercial payers such as insurance companies and employer-sponsored health plans. This increase translates to an additional claims cost to private payers of about $5 per member per month. Moreover, the study found that private payers can make minor changes in their benefit plans to assure the affordability of innovative therapies for their members. The Milliman study reports that the costs of innovative therapies will generally not create a large cost burden relative to other costs for private healthcare payers by 2011. The total cost for all innovative therapies (existing and new) approved by the US Food and Drug Administration (FDA) is estimated to be about 6 percent of total private commercial payer costs by 2011. This compares to about five percent for 2006. The study points out that innovative therapies may actually bring down healthcare costs in some cases. The report notes that new and improved medical treatment does not necessarily cost more than traditional treatment "The largest healthcare expense borne by payers is not prescription drug and biologic costs but hospital and other non-drug costs," stated Bruce Pyenson, principal and consulting actuary, Milliman, and author of the report. "While prescription drug costs account for about 14 percent, non-drug costs account for 86 percent of expense borne by payers, according to Milliman's 2006 Group Health Insurance Survey of HMOs." Source: www.bio.org   Europe loses as trialogue talks fail on proposed Advanced Therapies Regulation EuropaBio, the European Association for Bioindustries, has expressed its disappointment over the breakdown in the informal talks between the Parliament, Council and Commission which were looking to reach an early agreement on badly needed advanced therapies regulation, but instead ended without any concrete outcome. The informal trialogue meeting talks broke down when the Rapporteur insisted on including two amendments in the agreement package that would exclude certain advanced therapy medicinal products from the scope of the regulation. To include these amendments would cause certain products and technologies to remain unregulated, posing potential health hazards to European patients and disadvantaging Europe's emerging Advanced Therapies sector. EuropaBio calls upon the Rapporteur to continue with the approach that had been originally agreed. Insisting on a short-term push to include these amendments into the compromise package creates the risk of losing out on the long awaited objective to have advanced therapies regulated at European level for Europe's patients, clinicians, researchers and industry. Holding up the adoption of the Regulation in this way is not serving Europe's science base and the progress in medicines for the benefit of European citizens and patients. Following the rejection of the rapporteurs' report on the Advanced Therapies Regulation by the ENVI committee in September of 2006 for this very reason, the European Commission and the Council had proposed, instead, to let Member States take decisions on this sensitive issue based on the principle of subsidiarity rather than compromise on safety standards. Europe has been waiting for this legislation for a long time. This delay will cause serious problems for innovative companies and could affect the future of the life science sector. Ultimately though, it is the patients who lose out as they wait in vain for treatments that could make their lives better. Source: www.europabio.org   BioImpact.org relaunched On the occasion of Biovision, the World Life Sciences Forum in Lyon, France Biotech, (the French Biotechnology Industry Association), BIA (the UK BioIndustry Association), EuropaBio (the European Bioindustry Federation), Leem (Les Entreprises du MÃ©dicament- the French Pharmaceutical Industry Association), and LIR (Laboratoires Internationaux de Recherche) launched the new version of www.bioimpact.org and new findings about the impact of biotechnology on the treatment of diseases heavily affecting millions of patients: breast cancer, cardio-vascular diseases, inflammatory bowel diseases and chronic inflammatory joint diseases in particular. With a renewed website, BioImpact.org provides the visitor with patient testimonials and science based information, presented in simple and accessible fact sheets, videos and detailed reports including all scientific references, for those who are willing to learn more about the pathologies, the biotechnology treatments and how they save lives, help patients and serve our society. With more than 250 medicines and vaccines already available and more than 400 therapeutic products under development in 2006, the socio-economic impact of biotechnology is highly significant. The earlier edition of BioImpact.org showed the value of medicines discovered and developed by biotechnology and pharmaceutical companies; improved product safety, reduced side effects, new therapeutic strategies addressing unmet medical needs, or technologies improving public health coverage. The latest 2007 version of BioImpact.org includes additional information such as extensive European epidemiologic data (incidence, prevalence and mortality), quality of life data and economic data (economic costs of the disease, cost of biotherapy, cost/efficiency, target populations). It helps to understand how biotechnology is contributing to therapeutic progress and to public health and what is its real added value for our society, in terms of public health and in economic terms. Source: www.europabio.org   BIA hails S&T Committee Report on regulation of hybrid, chimera embryos Aisling Burnand The BioIndustry Association (BIA) of the UK has welcomed the House of Commons Science and Technology Committee report, which concluded that the creation of hybrid embryos should be permitted for research purposes. The committee also found that the proposals in a current government White Paper to prohibit the creation of hybrid embryos for research to be unacceptable and potentially harmful to the UK science. In a release, BIA noted that it believes the research using hybrid embryos could be a powerful tool that will help scientists to learn more about the differences between diseased and normal cells. Currently this work is stifled by a shortage of human eggs available for research. The research will be used to develop the techniques required for the production of stem cells, which could prove to be the source of treatments for diseases such as muscular dystrophy, Parkinson's and motor neurone disease. Aisling Burnand, chief executive of the BIA, said, "It is essential that this research is permitted so that many thousands of patients can benefit from new therapies in the future. It is important to safeguard the UK's position as a world-leading environment for cutting-edge research in bioscience as recognized in the committee's report. We look forward to contributing to the HFEA consultation on this issue later this year and hope it will take into account the views of the Science and Technology Committee." Source: www.bioindustry.org   ]]> <![CDATA[Agribiotech meet stresses on partnerships]]> https://biospectrumindia.com/news/95/1440/agribiotech-meet-stresses-on-partnerships.html https://biospectrumindia.com/news/95/1440/agribiotech-meet-stresses-on-partnerships.html Mon, 07 May 2007 14:59:00 +0530 New Page 1 Agribiotech meet stresses on partnerships Release of Dr TM Manjunath's book Q&A on Bt-Cotton in India The Association of Biotechnology Led Enterprises (ABLE) organized an agribiotechnology conference on April 12-13, 2007. The aim of the conference was to bring together the public and private institutes in the sector to jointly address the larger issues of propagation of modern technology to increase productivity, yield, and nutritional value of agriculture. And the living conditions of the farmers. In tune with the theme of the conference, public-private partnership in promoting agribiotechnology in India, the conference was held at the campus of the Tamil Nadu Agricultural University in Coimbatore, the country's premier agricultural university. Prof. MS Swaminathan, chairman, MSSRF and Dr MK Bhan, secretary, department of biotechnology (DBT), delivered the keynote address during the two-day conference. Prof. MS Swaminathan called for partnerships, synergy, and symbiosis. "We need partnerships and not partisionship. While universities were doing science (research), the private sector was doing technology (development). These two need to converge," said Prof. Swaminathan. The inaugural session included talks by Prof. C Ramasamy (vice chancellor, TNAU), Dr KK Narayanan (president, ABLE), Dr N Mahalingam, chairman, Sakthi Group of Companies, and M Ramasamy, managing director, Rasi Seeds. The inaugural session was followed by panel discussions on several subjects. Dr P Ananda Kumar, principal scientist, NRC for Plant Biotechnology, IARI and Prof. Balasubramanian, director, CPMB, TNAU, chaired the discussion on "Agribiotechnology Innovations: Stock taking and Finding Synergies", which included speakers like Dr Richard Broglie, director, R&D, DuPont, Dr Bharat Char, principal scientist, biotech R&D, MAHYCO, Dr KS Mohan, function lead, biotech product support and product launch liaison, Monsanto Research Center, and Dr Vai Ramanathan, head, genomics, Metahelix Life Sciences. This session was followed by a public lecture, "Does India Need Transgenic Crops?" by Dr KK Narayanan and then by a panel discussion on "Public-Private Partnerships in Promoting Agribiotechnology in India". The discussion was moderated by Dr Gautham Nadig, director, Metahelix Life Sciences. The panel comprised Dr P Ananda Kumar, Dr Jagadish Mittur, director, Monsanto Research Center, Deepanwita Chattopadhyay, CEO, ICICI Knowledge Park, Dr Sudeep Kumar, technology networking and business development, CSIR. The second day of the event began with a session on "Commercialization of Crop Biotechnology-Creating a Facilitating Environment". This was chaired by Dr MK Bhan and co-chaired by Dr Jagadish Mittur. The speakers included Dr Malathi Lakshmikumaran, consultant, Lakshmikumaran and Sridharan, Dr George John, advisor, DBT, and Dr Sudeep Kumar. During the conference, the ABLE Award for Excellence in Agricultural Sciences was conferred on Dr R Krishnamurthy, director, research, Rasi Seeds, in recognition of his outstanding contribution in the field of cotton hybrids. Note: The complete details of the deliberations of the panel discussions will be available on www.biospectrumindia.com.   ]]> <![CDATA[Stage set for Bangalore Bio 2007]]> https://biospectrumindia.com/news/95/1708/stage-set-for-bangalore-bio-2007.html https://biospectrumindia.com/news/95/1708/stage-set-for-bangalore-bio-2007.html Mon, 07 May 2007 14:37:00 +0530 New Page 1 Stage set for Bangalore Bio 2007 Bangalore Bio 2007, the country's flagship biotech event promoted by the Karnataka government and organized by the Karnataka Vision Group on Biotechnology, will be held from June 7-9, 2007 at the Bangalore International Exhibition Center (BIEC). The Karnataka government IT, BT, science and technology secretary, MN Vidyashankar remarked, "This flagship biotech event effectively positions Karnataka on the global map. We are now in the 7th year of the event and we are glad to announce that the success ratio of the event shoots up year on year. The state government's vision of the biotech park will materialize soon and Karnataka will be efficiently poised to take advantage of global opportunities" Bangalore Bio has emerged as a unique platform for the biotech fraternity to come together. The focal theme for this year is "Think BIG-Think Biotechnology, Think Innovation, Think Growth". Dr Villoo Morawala Patell, founder and CEO, Avestha Gengraine Technologies, said, "The face of competition today is global, and the Bangalore Bio platform allows lasting contributions to advancing our global competitiveness, economic prosperity, and quality of life. This year we will see countries like Australia, Germany, France participating in the coveted event. This global recognition will pave way for the growth of Indian biotech companies and contribute to the vast knowledge exchange at this platform". Dr Kiran Mazumdar-Shaw, chairperson of the Karnataka Vision Group on Biotechnology and CMD, Biocon, said, "In keeping with our BIG vision, Bangalore Bio 2007 has been planned on a grand scale with a strong focus on investment through partnering. The increasing pressure on western biotechnology companies to address affordable drug development and research in general has launched India into prominence as a preferred international research partner. India today provides both human capital and cost effective value addition to research efforts across the globe. Bio-manufacturing and clinical development are proving to be India's key strengths. The aim is to combine these with high value innovation through international partnerships in a win-win manner. Bangalore Bio 2007 therefore has an appropriate byline: Think Biotechnology, Think Innovation, Think Growth-it is about thinking BIG for the biotech sector in Bangalore, in India and across the world." "The most exciting and up-to-date global technologies and business solutions will be the exceptional line-up at Bangalore Bio 2007. This event will present a 360 degree view of the biotechnology industry to help attendees fully understand today's global marketplace and build winning partnerships to benefit from the fast emerging opportunities. It will be an ideal forum for all the stake holders in the industry to meet and network," said Dr KK Narayanan, president, ABLE, and managing director, Metahelix. The event this year includes a strong international participation from Australia, Holland, France, the UK, Spain, Germany, Japan, Belgium, Bavaria, Pennsylvania, and Singapore. Domestic participation from various state governments including Himachal Pradesh, Rajasthan, Chattisgarh, Uttar Pradesh, Maharashtra and Andhra Pradesh has been confirmed so far. Bangalore Bio 2007 International conference The conference promises to be a convening of many of the field's leading thinkers and doers for a series of lively panel discussion, interviews, talks and informal events that will help understand where things as headed and to join the path of growth. On a very special visit will be Prof. Sir David Lane, who is one of the world's most important cancer research scientists following his discovery of a critical tumor suppressor gene named p53. David Lane is the second most highly cited scientist in the UK over the last decade, reflecting his extraordinary impact on cancer research internationally. Agri Biotech Day The Agri Biotech Day on June 9 will showcase India's experience and progress in agribiotechnology. CEO conclave The CEO conclave is an exclusive industry get-together. This year will see a panel discussion on public health with the likes of Rajat Gupta, Rohini Nilekani, Dr Bala S Manian being part of the panel. Poster session This year too, Bangalore Bio will host the poster session in conjunction with the international conference. Industry visits In conjunction with the conference, industry visits are being organized for the interested delegates on first-come first serve basis. Trade show The trade show cover over 4,500 sm of air-conditioned state-of-the-art facility and is expected to attract over 20,000 visitors. Career forum Bangalore Bio 2007 will focus on addressing the issues related to the talent requirement in the industry and opportunities available in the various fields of biotechnology. Bio Awards Nite The Bio Awards Nite recognizes the contribution of eminent Padma Awardees for their outstanding achievements in the field of Science & Technology. ]]> <![CDATA[Biotech's long march]]> https://biospectrumindia.com/news/95/1714/biotechs-long-march.html https://biospectrumindia.com/news/95/1714/biotechs-long-march.html Mon, 07 May 2007 14:19:00 +0530 New Page 1 Biotech's long march According to the Chinese Academy of Sciences, China is likely to become one of the top five countries in the world in terms of scale of biotechnology industry by 2020 Ivy Teh is the Healthcare and Life Science Global Head at Clearstate in Singapore. She has advised international biotech companies on market entry strategies, acquisitions, R&D outsourcing, competitive benchmarking and marketing strategies. The Chinese biotechnology industry offers immense potential for global companies due to its vast market place, low-cost pool of professional talents and extensive research and development infrastructure. In 2003, the Chinese biotech market was valued at $3 billion and is projected to reach $9 billion by 2010, growing at a CAGR of about 17 percent. The industry is one of the key areas for China's high-tech competitiveness and is expected to account for around seven-eight percent of GDP by 2020. According to the Chinese Academy of Sciences (CAS), China is likely to become one of the top five countries in the world in terms of scale of biotechnology industry by 2020. The biotechnology market in China consists of agricultural biotechnology, biopharmaceutical, industrial biotechnology, biological resources technology, and environmental biotechnology â€“ with agricultural and biopharmaceutical segments being the prime drivers of growth. Biopharma & agribiotech lead growth The biopharmaceutical industry, aided by strong government support, active efforts of biopharmaceutical companies, and a growing demand for prescription drugs, is a key contributor to the overall development of China's biotech industry. In 2004-05, the Chinese biopharmaceutical market grew by 30.2 percent, accounting for 7.5 percent to the total pharmaceutical sales in the country and seven percent of total global sales. Even though, China's biopharmaceutical industry is still considered rather small in global scale, its rapid growth is poised to continue. Currently, China is home to more than 400 biopharmaceutical companies and is fast becoming one of the key outsourcing hubs for the sector in the world. Agricultural biotechnology is the other key growth segment. China is second after the US in terms of investment in agricultural biotechnology and is continually increasing its investment in research and development in this sector. Currently, agricultural biotechnology accounts for nearly 42 percent of the total government spend on biotechnology and about 37 percent of the total biotechnology market value. Growth in agricultural biotechnology will be fuelled by the increased need for food grains, with China expected to increase grain yield per hectare by 50-60 percent to cater to an increasing population. Rice, wheat, corn, cotton, soybean and canola crops are the main commodities expected to be genetically-modified by 2010. Government backs domestic players China has been aggressively investing in biotechnology. Over the period 2001-05, the annual government investments increased significantly by 400 percent (CAGR of 200 percent) from $100 million in 2001 to $1.2 billion by 2005. This figure is expected to reach $8.8 billion in 2010 as the government intends to transform China into one of the leading biotechnology player in the world. According to the 2006-2020 National Medium and Long-term S&T Development Plan, the government is expected to invest $111.8 billion or 2.5 percent of expected GDP, into overall research and development (all sectors) by 2020, with the development of biotechnology being considered the top priority over other industries. China currently has around 2,500 modern biotechnology companies, more than 20 biotechnology parks located in Beijing, Shanghai and Guangzhou, and major research and development centers in Beijing, Shanghai, Xi'an, Tianjin and Nanjing. In addition, favorable policies related to taxes, finance and human resource have also created a favorable environment for the industry stakeholders as well as potential investors. In the future, the government is expected to encourage biotech companies to increase their capabilities for original innovations. China's biotech companies are still largely generic manufacturers. However, this situation is changing as companies are becoming more active in innovating to compete in the global arena. The government is expected to strongly encourage this trend by taking serious measures to address IP shortcomings in accordance to TRIPS (Trade-related Aspects of Intellectual Property Rights) and to undergo various regulatory reforms in its healthcare system, product approval, pricing and taxation policies. Cost arbitrage attracts foreign investors China is a highly attractive market for international biotech companies keen to leverage on its low cost set up for manufacturing units and R&D, its large pool of low cost professionals, and a relaxed regulatory environment. International companies (such as DuPont, Invitrogen Corp., Dragon Pharmaceuticals Inc. and GeneMedix plc) typically enter this market through joint ventures with local firms, setting up manufacturing bases in China, or outsourcing R&D to local firms. Till the end of 2005, China had about 750 R&D centers supported by foreign capital in the form of joint ventures. Bridge Pharmaceutical Inc., which opened a research centre in 2006 employing 200 people, cited that its drug development cost is around 80 percent lower in China as compared to the US. Large international pharmaceutical companies like Novartis and Pfizer have also established research facilities in China primarily because of its low-cost research talent pool, with the cost of research scientists estimated to be five-10 times lower than in the US. However, the scope for outsourcing business in the biotech sector to China is still huge with global firms outsourcing less than five percent of their total requirement to China. Is China trailing India? While China is expected to dominate the global markets in the future, it is expected to face challenges from other Asian countries such as Singapore, Taiwan, Korea and India. Amongst these, India with its highly qualified researchers and vast market is expected to give China a run for its money. India offers a huge market for biotech products and has advantages of low-cost technology (for clinical trials, R&D, molecule synthesis), reasonable cost scientists and researchers, a network of bioscience centres and a strong IT infrastructure. The biotech work outsourced to India is in the form of contract research, clinical research, and research process outsourcing, which started in 2004. As China has focused on agriculture biotech products (BT cotton, rice crops), biotech protein drugs, and traditional Chinese medicine, India has achieved success in areas of enzymes, vaccines (recombinant Hepatitis B), diagnostics and veterinary products (animal health products). Both the Indian and Chinese governments are determined to build this sector and have put in place various investment-friendly measures to encourage growth. While the Indian government offers 150 percent weighted average tax deduction of R&D expenditure for recognized R&D facilities, the Chinese government provides biotech firms with around two-year tax exemptions on profitability. This is followed by a 50 percent rebate on enterprise tax for the next three years, which is usually extended for another three years. However, both countries are considered to be handicapped by poor IP laws -while India is perceived to have started improving its IP laws, China still lags behind. The Indian government has recently shifted its patent regime from a process based patent regime to a product based patent regime.   ]]> <![CDATA["We believe in sharing the success with our distributors"]]> https://biospectrumindia.com/news/95/2264/we-believe-in-sharing-the-success-with-our-distributors.html https://biospectrumindia.com/news/95/2264/we-believe-in-sharing-the-success-with-our-distributors.html Mon, 07 May 2007 13:59:00 +0530 New Page 1 "We believe in sharing the success with our distributors" -Wataru Tajima, deputy managing director, Shimadzu Analytical (India) Shimadzu Analytical India Pvt Ltd, a group company of Shimadzu Corporation, Japan, has been in the Indian market for the last 40 years providing solutions for quality control and to the R&D labs. Seeing an increase in demand for new and sophisticated instrumentation solutions, Shimadzu set up its customer support center in India during the first half of 2006. Wataru Tajima, deputy managing director, Shimadzu Analytical (India) Pvt Ltd, spoke to BioSpectrum about Shimadzu's plans for India. Excerpts of the interview: What are some of the reasons for Shimadzu to step up its investments in India? Indian companies earlier were involved in reverse engineering of the processes. But now they are following the methods of the US and European pharmacopoeia. At present, Indian companies are developing new methods and tools to cut short the drug development process. It is a slow process and takes time. Things are however changing. Five years ago, when our customers were buying the instruments, they had to be made aware of the use of instruments. We, as instrument manufacturers', try to give them advice on how to make their research activities easier and overcome the challenges in reducing the development cycle. This is what we have in mind and are trying to do this in India. The customers will value this kind of advice. How has Shimadzu India's business grown in the last one year? In April 2006, we set up our customer support center. We are serious to serve the customers and the industry better and to train the new sales force that has joined our distributors. It has brought a lot of confidence among our customers and also among the sales and services team of the distributors. We grew nearly by 33 percent during the last year through our distributors. Our philosophy is doing business through distributors. What is the differentiation that you offer to the Indian customer? We were earlier not able to deliver to our fullest extent. So in 2006, we focused on upgradation of the skills of the younger generation. We basically helped customers to evaluate the systems, machines, or instruments. We also provided training to the people who bought our systems. By doing this, we have taken care of the training needs of the customers as well as the sales force on how to use and operate our systems. Do you have any plans to enter the market directly in India? We work with the distributors and we are not thinking of entering the market directly. We have been successful using the distributors approach. We are not thinking of breaking the rule and starting new things. We will give the benefit to a distributor and continue to support the distributors in the life sciences space. This is our long-term strategy to be a successful player in the life science space. We believe in sharing the success with the distributors. Are you considering to add new distributor? No. There are about 200 people working with the four distributors that we have who are focusing exclusively on Shimadzu products. We wish to reduce the distributors burden by providing training and updating their staff on the latest instruments and its applications. It is time consuming and investment intensive. We will try to address such issues by offering them training programs so that they can cover larger geographical areas. We continue to educate the staff of our distributors. What are your immediate plans? We have upgraded our laboratories and introduced seven instruments. We have already completed two batches of training in India. It is a competitive world. This year our focus will be on using our sales force (small in size) on the fields and on services side. This is for the sophisticated instruments. It does not really have a big market in India. Second, we want a change a bit and move forward. With the growing demand, we continue to do training programs on applications for the sales force of our distributors. How do you see India as an opportunity compared to China? India is our potential market. China definitely will saturate soon. The life sciences and the education market in China is nearing saturation point. However, the market base is very broad in China. It depends on the politics in a nation. We hope that it would stabilize soon. Narayan Kulkarni   ]]> <![CDATA[Automation in life sciences gains muscle]]> https://biospectrumindia.com/news/95/2936/automation-in-life-sciences-gains-muscle.html https://biospectrumindia.com/news/95/2936/automation-in-life-sciences-gains-muscle.html Mon, 07 May 2007 13:50:00 +0530 New Page 1 Automation in life sciences gains muscle In the era of industrialization and globalization, automation is a step beyond mechanization. The Indian biotechnology and pharmaceuticals sectors are expected to grow to $5 billion and $25 billion in revenues by 2010, with bulk of these revenues coming from exports. While the biotechnology industry has been growing at over 35 percent, the pharma industry has been registering a growth of 10 percent. Today, India has the largest number of FDA approved sites outside the US. Companies like Bharat Biotech, Biocon, Dr Reddy's Labs, Nicholas Piramal, Ranbaxy, Reliance Life Sciences, Sun, Serum Institute of India, Shantha Biotechnics, and Wockhardt are vying for a major share in the global markets. "The Indian pharmaceutical companies, keeping abreast with the global developments and adopting new technologies with relative ease, have created GMP complaint facilities to produce and formulate drugs," said Raja Bahadur V Arcot, director, South and South East Asian Operations, ARC Advisory Group. The industry's main forte continues to be generic drug market, though some of them have adopted the drug discovery path too. "With generics pipeline worth around $30-40 billion, the Indian pharmaceutical companies have ample growth opportunities and some of them have taken the route of growing through mergers and acquisitions. While these companies are expanding their reach beyond the Indian market, it is time for them to evaluate how well they are leveraging automation technologies to achieve agility, supply chain efficiencies and productivity improvement across globally-extended and networked enterprises." According to Harshavardhan Chitale, vice president, strategy and global marketing, Honeywell Process Solutions, companies will have to invest in automation as a business enabler and not as a technology enabler to become more agile, gain visibility across the extended supply chain and synchronize their production and business decisions. Emerging industry Automation is finding acceptance not just in large integrated manufacturing industries but also in medium and small units. The size of the total automation industry in India is about Rs 4,000 crore and is expected to grow at 20-25 percent per annum according to the Automation Industry Association of India. Pankaj Joshi, general manager, marketing, Rockwell Automation India, said, "The market for automation in the life sciences sector is worth Rs 130 crore in India and is growing at a rate of 20 percent. Although there are not many players in this space, there is competition in the low value market wherein the solutions have been offered to the OEM players for as low as Rs 1 lakh." Globally the automation market in life sciences space is about $1 billion. Automation Solutions Automation plays an increasingly important role in the global economy as engineers have been able to combine automated devices with mathematical and organizational tools to create complex systems for a rapidly expanding range of applications and human activities. There are several different types of automation tools tools. Artificial Neural Network (ANN) Batch Management System (BMS), Manufacturing Execution System (MES) Distributed Control System (DCS) Human Machine Interface (HMI) Laboratory Information Management System (LIMS) Programmable Automation Controller (PAC) Programmable Logic Controller (PLC) Simulation Supervisory Control and Data Acquisition (SCADA) "At present the share of life sciences in the Indian automation industry is in the range of Rs 100â€“150 crore growing at a rate of 12-15 percent," stated JP Singh, president of Automation Industry Association (AIA). The contribution of the life sciences industry to the overall revenues of the automation industry is very small because the pharma and biopharma plants are not as big as those in the oil and gas or power generation and distribution sectors. "It would increase in the near future as most of the companies in the life sciences industry are going global and want to be very competitive at the global levels," said Singh. According to Jeffrey Sladecek, business manager, Rockwell Software, Asia-Pacific, FDA regulatory compliances, in-patent production ramp-ups, and quality through corrective and preventative action are driving the pharmaceutical and biotechnology industries to look at automation. "Automation will help the companies to take care of their functional needs like document management, product tracking, and electronic signature or batch records." Life sciences sector, an important focus area ABB, Emerson Process, Honeywell, Invensys, Rockwell, and Siemens are some of the major players in the Distributed Control System (DCS) in India. Besides these, there are other technology providers, system integrators and information technology integrators who have been active in automation systems in India. Emerson Process is a leading player in the DCS space in India and has close to 40-50 percent share of the total DCS market. The other major players in this segment are Honeywell and Siemens. Currently this market is growing at nearly 20 percent year on year. Besides sheer growth, there is also a qualitative shift in terms of market characteristics. Sunil Khanna, managing director, Emerson Process Management India, said, "Over 100 life sciences companies have made investments on automation. But they are yet to automate their entire facilities or plants. Emerson has over 60 installations in the life sciences space, 17 of which were done in the last one year." Gerhard Klement, president and CEO, biopharmaceuticals, Reliance Life Sciences, said, "We have been making investments on automation systems so as to integrate our systems and enhance the networking activities." Sunil Khanna added, "Earlier the life sciences companies' annual spending on automation was about Rs 2 crore, but this figure now is going up to Rs 25 crore." Ravi Uppal, vice chairman and managing director, ABB Ltd, noted, "In the present competitive market, every company, including that in the life sciences industry, wants to outdo the other and provide the best to the customer. It's a healthy sign for the growth of the automation industry. However, the lack of awareness and knowledge about automation is a big impediment. It needs to be addressed immediately." "To bring in awareness about the benefits of automation, AIA has been conducting programs in association with the sector-specific industry bodies and government. We haven't yet conducted any such program for the life sciences sector. AIA is keen on organizing such awareness programs in life sciences too," reiterated JP Singh. Companies are now no longer looking at automation as an infrastructure, but as an enabler of productivity, quality and safety. "Pharma companies today are buying advanced applications such as MES, tracking and supply chain solutions as the experience of last few years has established the high ROI potential of such solutions. Process control solutions are no longer a luxury that only large chemical plants would implement. Even smaller enterprises in industries such as dairy and specialty chemicals have started reaping the benefits of automation. Companies have started realizing that the true value comes not from 'hardware' but from applications and engineering and the propensity of Indian customers to pay for the same has gone up significantly," added Harshavardhan Chitale. The life sciences companies, clearly, are beginning to leverage automation and information technologies to achieve global competitiveness. They are beginning to install automation systems and enterprise solutions extensively to benefit from the global growth opportunities by enhancing productivity, ensuring better deployment of resources and gaining time to market advantages. Narayan Kulkarni   ]]> <![CDATA[Bannari Amman Group starts Tamil Nadu's first biodiesel plant]]> https://biospectrumindia.com/news/95/8146/bannari-amman-group-starts-tamil-nadus-first-biodiesel-plant.html https://biospectrumindia.com/news/95/8146/bannari-amman-group-starts-tamil-nadus-first-biodiesel-plant.html Mon, 07 May 2007 13:08:00 +0530 New Page 1 Bannari Amman Group starts Tamil Nadu's first biodiesel plant Union minister of state for rural development, Chandra Sekhar Sahu (third from right), unveiling the plaque to inaugurate the biodiesel plant. Tamil Nadu's first and the world's 141st biodiesel manufacturing plant, set up by the Bannari Amman Group, has started functioning at Sathyamangalam, nearly 60 km from Coimbatore. The plant, which produced 3,000 liters of biodiesel from jatropha and pongamia seeds, was inaugurated by the minister of state of rural development, Chandra Sekhar Sahu, on April 7. "This is part of our group's mission to recognize the importance of environment and safeguard the economic future of the country," said Bannari Amman Group chairman, SV Balasubramaniam. The only other biodiesel plant in south India is in Andhra Pradesh. Most of the biodiesel plants abroad use sunflower, rapeseed or soyabean as the feed stock. The Bannari Group has chosen jatropha as the country cannot afford to use edible oil bearing plants as raw materials while the nation is importing edible oils. Subramaniam said studies have shown that jatropha, which grows well in wastelands, provides one of the highest oil yield among tree-borne oil seeds. India has nearly 33 million hectares of wastelands which could be used for cultivation of such oil-bearing plants. The government has allowed blending of 5 percent of biodiesel with conventional diesel. India's national policy on biofuels aims to permit a maximum blend of up to 20 percent, which will not require any modification to automobile engines. The company has trained farmers to grow jatropha and have educated the reluctant farmers about the usefulness of growing biodiesel bearing plants. Over 1,700 acres of jatropha plantations has been done by the company in the adjoining areas of Sathyamangalam, nestling in the foothills of the Nilgiri mountains. Subramaniam said the company has arranged soft loans at 7.5 percent to the farmers to take up jatropha plantations and has also signed buy-back arrangements at prevailing market price. Studies have shown that biodiesel blend reduces carbon emissions by 78 percent compared to conventional diesel. Leading oil marketing companies are buying biodiesel from the producers at Rs 25 per liter. Subramaniam requested the government to increase the procurement price of diesel to compensate for the increased input costs. More importantly, he wanted the government to announce a National Biodiesel Policy. Minister Sahu said the policy was under formulation and would be announced soon. The industry has also demanded exemption from customs and excise duty to capital goods and machinery used in biodiesel production. The industry wants the waiver of 3 percent central sales tax on methanol. N Suresh   ]]> <![CDATA[Merge, acquire or expire]]> https://biospectrumindia.com/news/95/2313/merge-acquire-or-expire.html https://biospectrumindia.com/news/95/2313/merge-acquire-or-expire.html Mon, 07 May 2007 12:39:00 +0530 Merge Merge, acquire or expire This is the survival mantra for life sciences companies, globally, more so across the Asia Pacific region, and especially in the biopharma segment. There is a distinct trend of Asian companies expanding footprint, building ground presence, in short going global through the acquisition route. In fact, there are two distinct trends. One, MNCs gaining foothold in Asian markets via acquiring a majority stake of businesses in high-potential markets like India and China and two, Asian companies establishing presence in the US or European markets via acquisitions and consolidating presence in Asian markets inorganically through mergers or acquisitions. And it is the latter trend, which is emerging to be stronger of the two showing signs of picking up further. Dominant trends For the next five years consolidation will be the primary theme in the life sciences sector in Asia. Also, the consolidation trend is strongest in the generics space. And most of this merger & acquisition (M&A) activity is taking place in China & India. Bundeep Singh Rangar, Chairman of the UK-based IndusView Advisors, in his recently published report states that the Indian pharma sector accounted for nearly $2.5 billion worth of M&A deals in 2006 compared with just $364 million the previous year. According to the Ernst & Young's 2006 Global Biotechnology Report, most of the deals in the Asia Pacific region are driven by the need to increase access to these large and growing drug markets, and by the need to lower the costs of drug development. While patent expirations are fuelling the increased deals in the generics segment, the number of deals in vaccines was energized by concerns around the avian flu, SARS, and biodefense products. According to Research and Markets, China is witnessing a major merger and reorganization among biotech companies and large-scale pharmaceutical enterprises. Some recent examples include Taiji Industry acquiring Chongqing Traditional Chinese Medicine, Shanghai Pharmaceutical's buy-out of Shandong Xinhua Pharmaceutical and Topsun Group's acquisition of Hubei Qianjiang Pharmaceutical. While the Asian companies have sensed the big opportunity and are moving in to make gains the big pharma is making its moves to retain leadership. A key factor that is forcing big pharma to allocate substantial resources for strategic transactions with biotechnology companies is, of course, the fact that a considerable number of blockbuster drugs will soon lose patent protection. Patent expirations are in turn fueling the demand for innovative technologies and products to fill big pharma's thinning product pipelines. This is driving an extraordinary push to in-license biological products or to acquire biotechnology companies that are rich in promising drug candidates. During Q2, 2006, pharma companies spent over $2 billion in acquisitions. The big ones of course were Merck's acquisition of GlycoFi and Abmaxis and Pfizer's acquisition of Rinat. In each of these acquisitions, a big pharma company and the smaller biotech company had earlier entered into a strategic alliance. While Merck has collaborated with biotech companies in the past - 16 deals since 2000 â€“ its May 2006 acquisitions mark the company's first strategic, long term commitment to building an infrastructure for the development and manufacture of biological products. Following the Merck example, many other pharmaceutical companies have been snapping up companies with biologics, especially antibodies, the hottest class of molecules in development today. Both big pharma and small biotechs have become more flexible in exploring deal terms that help both entities achieve financial and strategic business objectives. Biotech deals follow the buck According to the Burrill Biotech figures for Q4, 2006, this was a big year for biotech/ life sciences fund raising. Financings and partnering deals brought in a record $47 billion for US companies with over $27 billion through financings and $20 billion in partnering capital." In total biotech raised $6.2 billion in Q4, 2006, picking up the pace again after Q3 06, which saw only $2.4 billion collectively raised by the industry. "But what is driving the hectic pace of activity in the biotech space is rising drug development costs, tougher regulatory approval processes and unexpected clinical trial results, companies are looking at safe survival tactics," explained Sergio Garcia, co-chair of the life sciences group of the UK-based consultancy, Fenwick and West. Biotechnology company executives also must contend with the uncertainty of going public. The cost and burden of compliance with Sarbanes-Oxley requirements makes being a public company more expensive than ever-130 percent more expensive according to a recent Goldman Sachs estimate. Overview of Mergers & Acquisitions in the Asia Pacific Region in 2006-07 Country M&A deal Segment India Dr Reddy's Lab buys Germany's betapharm for $570 million Pharma India Ranbaxy acquires Terapia for $324 million Pharma India Zydus Cadila acquires Liva Healthcare Pharma India Nicholas Piramal acquires Pfizer's UK facility Biotech Germany Bayer AG acquires OTC drug maker Jiangsu Qidong Gaitianli Pharma Australia Peptech acquires Promics Biotech Japan Eisai acquires California-based Ligand oncology portfolio Pharma China American Oriental Engineering acquires Heilongjiang Qitai pharmaceutical Pharma Hong Kong CK Life Sciences buys 80 percent stake in Vitaquest for $166 m Biotech China Beijing Med-Pharm Corporation acquires majority interest in Shanghai Rongheng Pharmaceutical Pharma Malaysia Welch Allyn acquires Malaysian medical products distributor MediAids Medtech Singapore CyGenics boosts Malaysian presence, acquires 20 percent stake in DNAPro Pharma India Orchid acquires 100 percent of Bexel discovery entity pharma Australia Australia's biotech major CSL acquires Zenyth Therapeutics Limited Pharma Australia Hospira acquires Mayne Pharma for $2 billion Pharma India Ranbaxy acquires GSK's unbranded generic business in Italy Pharma India Strides Arcolab acquires Singapore generics manufacturer for $12.52 mn Pharma Australia Mayne Pharma acquires SuperGen oncology products Pharma China Inverness Medical acquires ACON laboratories China facility Medtech   In addition, companies that would once have pursued an IPO are finding that the IPO bar is set much higher than in the past-with IPO investors demanding to see a path to revenue and profitability. Biotechnology companies are finding that partnering continues to be a viable strategy to mitigate market and regulatory risk, and to maximize the probability of success for their development programs. Smaller biotechs follow exit strategies For small biotech firms, mergers essentially serve as exit strategies as most of them have touched a financial dead-end due to soaring R&D expenses. Since these companies do not have the wherewithal to market and commercialize their products, they prefer merger with larger pharma companies who have deep pockets and excellent marketing, mass-production and distribution resources. By merging with a big pharma company, smaller biotechs can focus on specific drug applications and develop them until they are ready for market. Mergers also help smaller companies get access to research and intellectual property. Merging gives an opportunity to re-examine existing alliances and eliminate unwanted associations. An alternative to merging is to form alliances with service companies that specialize in everything from research to clinical trials. This solution may allow a small company to maintain its autonomy and grow large enough to demand a higher price in an eventual merger. From the big pharma perspective, most large pharma giants may find themselves competing with numerous small, specialized companies that can each outperform them at individual tasks. By acquiring smaller drug developing companies, they can increase the product pipeline without sacrificing efficiency or long-term growth. The general trend According to PricewaterhouseCoopers, during 2005 M&A activity in the pharma and healthcare sector remained buoyant with a total of 2048 deals worth $152 billion. Other stats by Ernst and Young that track pharma and biotech note that in 2006, the M&A activity continued to dominate the market, only this time the activity grew by 60 percent with average premium in M&A transactions valued at $500 million. Glen Giovannetti, Ernst & Young's Global Biotechnology Leader, elaborated that in many ways, 2006 was the year of the deal - but this is all the more remarkable because there was no one deal of the year. "In prior years high deal-value totals were typically driven by a single mega deal, but in 2006 we now have widespread recognition among buyers of the potential value in biotech's platforms and pipelines. That's remarkable, and a testament to the tremendous innovation of the global drug development industry," he said. Utkarsh Palnitkar, Head, Health Sciences Practice, Ernst & Young, throws light on the Asian scene. He elaborated, "Asian biotechnology companies face critical challenges in their efforts to accelerate the transition to become enterprises driven by research and development. Companies are leveraging the Asian advantage in bio-manufacturing and contract services arena and utilizing them to drive the growth story in drug discovery and research." In Asia Pacific, governments and companies are moving aggressively to make the transition from competing on cost to developing homegrown innovative pipelines. More companies are looking to reinvest revenues from services to develop innovative pipelines, and are mulling M&As to accelerate commercialization efforts. A case in point is Japan's active market, which saw big deals in the last two years. Among the notable ones are the $7.7 billion Sankyo merger with Daiichi Pharmaceuticals, Dainippon Pharmaceuticals $2.12 billion consolidation with Sumitomo Pharmaceuticals and Astella's Pharma's acquisition of North Carolina-based Dynogen Pharmaceuticals. Creating generics success through acquisitions Jonas Tryggvason, executive vice president of Iceland-headquartered Actavis Group for Central-Eastern Europe and Asia sales tells BioSpectrum how his company became one of the world's leading players in high-quality generic pharmaceuticals. Actavis owes its phenomenal growth to successful integration of a number of acquisitions of promising companies across the world. Excerpts from the interview: Tell us about your growth strategy? We follow a very aggressive growth strategy that is driven by acquisitions. In the last five years, we have made strategic acquisitions that allowed us to expand on a global scale, enhance our product pipeline, and strengthen our employee base throughout the entire group. As a global pharmaceutical company, we realized the potential of the US market, and aggressively expanded our capabilities to deliver there. The acquisitions of Amide Pharmaceuticals (2005), Alpharma Human Generics (2005) and Abrika Pharmaceuticals (Dec 2006) have allowed us to strengthen our foothold in this geography. The US division portfolio now comprises more than 185 projects in a wide range of dosage forms including tablets, liquids, ointments and growing presence in the controlled-release market. Our acquisition of Lotus Labs (Feb 05), an Indian CRO has bolstered our API production by providing access to lower cost CRO capabilities in India. How has the company fared in the last fiscal year? Following our strategy of acquiring newer product pipelines and entering into newer markets, we have garnered revenues of $1.8 billion (1.4 billion euros) at a growth rate of 168 percent in FY 2006. This year, we are still looking to acquire more companies and further expand our portfolio. Currently, we have 650 products in the market spread across 60 countries. We filed 30 ANDAs in the US market in 2006 and hope to increase that number in 2007. What is the key criteria you use when you acquire companies? Our first criterion is to see how well the new company fits with our existing organization; whether it can add value to us or vice versa. Secondly, the company we want to acquire also should have a unique product pipeline or a capability that we do not possess. Finally, we also acquire companies that give us a competitive edge and access to new geographies. What are your focus markets in Asia? We have active presence in India, China, Singapore and Vietnam and are mulling to enter Indonesia; currently we are charting a production plan for that region. India plays a very critical role for us, we have established our global centre for clinical research operations through the acquisition of Lotus Laboratories. In addition to this India also plays a key role in supply chain as we work with many API manufacturers and CRO companies in this country. Krishna Vilasini Bharadwaj   ]]> <![CDATA[VCs still shying away from early stage funding]]> https://biospectrumindia.com/news/95/2504/vcs-still-shying-away-from-early-stage-funding.html https://biospectrumindia.com/news/95/2504/vcs-still-shying-away-from-early-stage-funding.html Mon, 07 May 2007 12:31:00 +0530 New Page 1 VCs still shying away from early stage funding The biotechnology industry has been garnering attention from one quarter or the other in the last couple of years. It received the much-needed support from venture capitalists/private equity players in 2005-06. This year, the finance minister, P Chidambaram has batted in its favor, but the industry failed to retain the level of interest among the VCs in 2006-07. Data from the US-IVCA/Venture Intelligence study reveals that venture capitalists (VCs) have made four investments worth $16 million in the healthcare and life sciences industry during 2006. Of these, three investments were in the CRO space in companies like Ocimum Bio ($5 million from IFC), Accutest Research ($4 million from Aureos India) and Siro Clinpharm (undisclosed amount from Baring PE). The other investment was in the pharma space, according to Arun Natarajan, founder and CEO, Venture Intelligence. If one looks back at the previous year, there was a lot of enthusiasm among the VCs with regards to the biotechnology sector. On the VC front, the funding activity showed significant momentum during the year with the VCs getting more excited with the changed but more sustainable business models. Venture and corporate funding support to young biotech companies increased across various segments of biotechnology like bioinformatics (Ocimum and Molecular Connections), vaccines (Bharat Biotech), drug discovery (VLife Science Technologies, Advinus and Perlecan Pharma), clinical research (Manipal Acunova, SIRO, Metropolis), biopharmaceuticals (Zenotech), agbio (Metahelix), preventive healthcare (Avesthagen) and diagnostics (ReaMetrix). On the whole the sector attracted over $125 million funding, a 150 percent growth over the previous year. Observing this trend last year, Nitin Deshmukh, head, private equity, Kotak Mahindra Bank, noted that overall, India's biotech engine was revving louder, fuelled by increased venture capital funding and government support for sustainable business models and successful commercialization of biotech products. However, the same positive trend was not there in the second half of last year. Concerted efforts made by associations and organizations like ABLE to provide a platform for the VCs and the biotechnology companies to interact and meet each other's requirements, did not yield results in immediate terms. "There are assurances and promises. And it is surprising to note that not much has happened in biotechnology from venture capitalists/private equity players after a very good year in 2005-06," noted Nitin Deshmukh, who is also the honorary director of ABLE, the biotech industry association. He added, "VCs and PEs are quite happy in investing in mid-sized companies that are doing pretty well. They are still reluctant to take the initial risk by investing in early stage funding in biotech companies. However, we at Kotak are proactively keen on making investments in early stage biotechnology companies. By March 2008, there will be good number of investments from Kotak in early stage funding for the biotech companies." Contrary to the fact, GVFL Ltd has announced its first investment from the Biotech Fund in Ahmedabad-based Celestial Biologicals Ltd, an Intas Group company venturing into plasma fractionation and marketing of plasma derived proteins. "GVFL is providing early stage funding of Rs 2 crore to aid Celestial's expansion. We see immense potential and continuous growth for this innovative venture in the fast growing Indian plasma therapeutics market," said Vishnu Varshney, CEO of GVFL Ltd, while announcing the investments. Government look-out As usual the Central government has been making continuous efforts to support the niche biotechnology industry in all respects. "The department of biotechnology (DBT) has launched the Small Business Innovative Research Initiative (SBIRI) aiming at public-private partnership and forging effective links between academia and industry in upscaling and validation of laboratory research to commercialization. The overwhelming response from small and medium industries resulted in 200 applications and 34 proposals have been supported in areas of product development in agriculture, healthcare, aquaculture and animal sconces," said Dr MK Bhan, secretary, DBT, at the 21st biotech foundation day on February 26, 2007. Even the Maharastra government is proactive in providing timely and adequate credits and other financial needs to entrepreneurs for setting up biotech projects in the state. The state government has signed three MoUs on March 23, 2007 with three leading banks- State Bank of India (SBI), Punjab National Bank (PNB) and Yes Bank. Ashok Chavan, minister of industries, Maharastra government, said, "These MoUs are expected to ease out the key concern of getting adequate and timely credit to biotechnology entrepreneurs in the state, especially to the small entrepreneurs for biotechnology projects." "Investments in life sciences doubled last year with more deals in late stage" -Sarath Naru, managing director, APIDC Venture Capital Ltd   What have been the investments of the APIDC Venture Capital Ltd's Biotechnology Venture Fund in the life sciences sector during the last year? Ventureast, the only early stage VC has invested $16.9 million into 12 life sciences companies with a median deal size of $1.41 million Vs the industry average of $16-17 million per deal. The figure indicates our early stage focus in the life sciences space. The deals comprise both cross border and India opportunities in drug discovery, diagnostics, medical devices, research services and alternative energy. Early stage drug discovery ($5.47 million): We have invested in 3 companies: Evolva, Marillion and Melior. The first is a Swiss company with operations in India that has a proprietary genetic chemistry platform using natural chemistry to make safer drugs. Marillion and Melior are US-based companies collaborating with Indian companies to discover new drugs for cancer and diabetes. Diagnostics ($2.27 million): Elbit is India's pioneering medical diagnostics chain with outlets in Hyderabad, Chennai and Bangalore. The company is foraying into tier-two towns to provide high-end diagnostic services in collaboration with local hospitals. Over the next three years, the services will be extended to semi-rural areas as well. Elbit is enhancing diagnostic services in these areas by joining forces with existing hospital networks Medical devices ($1.24 million): We have invested in two medical device companies. The first one, Neurosynaptics, a Bangalore-based company, is enhancing primary healthcare delivery in rural settings. The company has developed a proprietary gadget that monitors cardiac performance in line with global standards but at a fraction of the cost of MNC equipment such as ECG machines. The second, Mardil (US-based) is developing the first cardiac device that addresses mitral valve problems with a minimally invasive surgical technique. Research services ($4.4 million): With three investments, Ventureast is leveraging the cost arbitrage Indian operations provide to service growing needs of the healthcare industry globally. Bioserve is a US-India cross-border company that provides pharmacogenomics services to make drug discovery geographically relevant. By identifying racially specific disease genes, the company is providing services to large pharma to enhance safety and efficacy profiles for genetically diverse populations. Cecilia's US-India team is building the first IT platform to design appropriate business models for health insurance in India. The third company, IMedX has built a proprietary web-based technology that combines unique technology and Indian cost arbitrage to service needs for small medical group practices and one-off hospitals in the US. These together comprise the largest part of the healthcare provider sector in the US. Alternative energy ($2.73 million): Our portfolio company, Naturol, is the first bio-diesel manufacturer in the country and one of the few in the world that has can use multiple raw materials. Most other technologies rely on jatropha plants or palm oil. Names of the VC/PE firms involved in the deals: Ventureast, Volrado Ventures, Temasek, Holdings, Newbridge, Capital, Spandana, Foundation, Blackstone, Actis, Quantum Fund, Blue Ridge, Sabre Capital, Spinnaker Capital, Deutsche Bank, Future Capital, ICICI Venture, IDFC PE, Carlyle Group, Sequoia Capital, Clearwater, New Vernon, Nomura and IFC. Do you feel there has been a change in the mindset of VC community during the last year? How do the VC/PE firms now look at biotechnology as area of investments? Though the amount invested in life sciences has doubled ($515 million Vs $269 million) in the last year, deals are late stage with Ventureast, the only company investing in early stage. With $515 million invested in 29 companies, the VC/PE community has almost doubled its interest since 2005 ($269 million in 16 companies). The average deal size remains about the same at $17.7 million Vs $16.8. However, the bulk of the deals (77.5 percent) were into growth, late stage companies or PIPE deals. Moreover, the deals reflect a preference towards manufacturing and services in pharmaceuticals and healthcare sectors. Ventureast is the only VC that has consistently over the last two years invested in early stage drug discovery and biotechnology companies with a product/IP focus.   What are your views on the government initiatives on research funds like DBT's Small Business Innovation Research Initiative (SBIRI), DST's Pharma R&D fund and their present status? The government has shown growing interest in life sciences, evident from funding initiatives for R&D. These include grants, low interest loans and indirect equity investments through VC funds. In addition to assisting existing companies, these schemes are now beginning to focus on early stage companies for indigenous drug development in academiaâ€“industry collaborations. Funds available through SBIRI, DST's Pharma Fund, NIMITLI and TDB have provided soft loans and grants to several companies to fuel innovation. But there are ways to improve this to bring in global competitiveness. Lately the TDB has begun partnering with VC funds to provide funding through equity investments. Ventureast is the first VC fund to attract TDB co-investment for life sciences funding. An approach that could further enhance fund usage would be for the government to partner with experienced investors more extensively. Publicâ€“private partnerships for investment have led to success stories overseas. Key advantages enabled by the partnering approach are: Critical access to additional rounds of funding due to longer incubation cycles Global exposure through investor networks to top-10 US pharma companies for early partnering Business and marketing hand-holding for technocrats Meanwhile, there are a few issues that might push back the flow of funds to the biotechnology industry. The Budget proposal to tax the venture capital funds by taking away the pass-through benefit in respect of non-specified areas is one such issue. Reacting to this, Nitin Deshmukh said, "Clearly, this is a severe restriction on the growth of VC/PE industry in India that is just about taking prominence on the back of a robust economy. The size of our VC/PE industry is minuscule by global standards and this unfair taxation and differentiation between sectors will hamper the growth of this industry. This would also adversely impact the availability of venture capital for companies seeking start-up or early stage capital in sectors outside those specified in this list. For example, any investment in other emerging sectors such as medical devices, diagnostic services, hospitals, tourism, food businesses, education and training, new financial services, specialty chemicals and consumables will not qualify for tax benefits under this notification and one wonders what is being achieved by having such a restrictive and limited list of 'Knowledge intensive sectors'. It would have been prudent for someone to analyze the size of these sectors vis-Ã -vis other developed countries before coming to any such conclusions on 'knowledge intensive sectors'. He added, "There will be absolutely no level playing field for Indian funds raising money from Indian investors as this gives a very unfair advantage to global funds which have the flexibility to route their investors money through tax-friendly countries which provide tax efficient structures. How can we encourage Indian investors such as banks, life insurance companies, pension funds, corporates and High Net Worth Individuals (HNWIs) participating in Indian VC/ PE Funds with such unfair restrictions vis-Ã -vis their counterparts in other regions of the globe?" On the other hand, the proposed service tax exemption to technology business incubators (life sciences and IT) and incubatees whose turnover is less than Rs 50 lakh would set to promote funding in initial stages to address the seed capital paucity, says Utkarsh Palnitkar, leader, business advisory services, Ernst &Young Pvt. Ltd. He noted that promoting entrepreneurship is the key rationale behind this initiative. In India, private equity or developmental capital is available in plenty. Besides benefiting from the government initiatives, it is now time for the big Indian biotechnology/pharmaceutical companies to support the small and upcoming biotechnology companies by taking stake and making strategic investments in the companies. In addition to working with MNCs, getting research contracts from MNCs, Indian players should look at smaller ones to growth mutually. It is time for the leading players to act like big brothers for upcoming small and medium sized biotech companies. This move will boost the growth of the SME sector and help in cluster development in India resulting in economic growth of the country. Narayan Kulkarni   ]]> <![CDATA[Diagnostics shifts focus]]> https://biospectrumindia.com/news/95/5385/diagnostics-shifts-focus.html https://biospectrumindia.com/news/95/5385/diagnostics-shifts-focus.html Mon, 07 May 2007 12:14:00 +0530 Diagnostics shifts focus Diagnostics shifts focus Molecular diagnostics addressing the pharmacogenetics testing segment will make up the lion's share of market growth. The global outlook for medical diagnostics is very promising for the current decade. Growing at a double-digit rate annually, it is set to be one of the most profitable sectors in the life sciences industry. The multi-billion dollar industry includes in vitro diagnostics (IVD), in vivo diagnostics and medical imaging. The $10 billion medical imaging segment primarily falls in the monitoring and detection realm as its offers hardware or the physical equipment/devices in diagnostics. Companies that dominate this space are GE, Siemens Medical, Philips and Kodak Healthcare. As a whole, medical diagnostics has played a crucial role in diagnosing cancer, cardiovascular disease (CVD), infectious diseases, diabetes and age-related neurodegenerative diseases such as Alzheimer's and Parkinson's. The big names in this industry are Roche, Abbott, Bayer, Dade Behring and Beckman Coulter. In 2004, the worldwide IVD market was pegged at $28.5 billion with Asia Pacific region and Japan contributing nearly 12 percent. Currently, Asia contributes a miniscule percentage to the whole. However, with big companies such as Roche, Bayer and Beckton Dickinson investing in Asia, the region is set to experience a boom in the field of IVD, particularly in the molecular and immuno-based diagnostics solutions segment. The shifts-in-progess Medical imaging to aid diagnosis: Imaging will remain a dominant method to diagnose and treat diseases. The outcomes will be more crucial as they form the basis for many clinical decisions to be taken. Pharmacogenomics to rule the roost: Molecular diagnostics addressing the pharmacogenetics testing segment will make up the lion's share of market growth. Currently, the second largest market sector after diagnostics for infectious diseases, the pharmacogenomics sector is projected to take-off from its current $3 plus billion in revenues to more than $60 billion in 2016. Companies shift focus: Pharma companies such as Roche and Novartis turn to personalized medicine to help improve the drug development process and speed the approval of new drugs. Cost and safety: Modern diagnostics from now on will address two key healthcare challenges - cost and safety. "Asia has a great potential for diagnostics - it's not just about its market size or high growth rate of sales. Owing to the increasing demand for improved medical products and safer, more effective healthcare services, Asian governments are increasing budgets for achieving higher healthcare standards," said Lucy Lu, vice president, Roche Diagnostics, while making a point, at a diagnostic event in Singapore, in 2006. IVD in cancer and cardiovascular disease In vitro diagnostics, which essentially mean testing in a lab or in a controlled environment, has led to many breakthroughs in disease detection and treatment. Its greatest contribution however, has been in the field of cancer detection. The innovations in IVD led to the development of new testing technologies in areas of cancer risk assessment, screening, prognosis and treatment monitoring. Global research firm, Frost and Sullivan valued the US cancer in-vitro diagnostics market at $881.5 million in 2005 and predicts it will touch $2.3 billion by 2012. According to Nobel Laureate and President of the Fred Hutchinson Cancer Research Center in Seattle, Dr Lee Hartwell, IVD and molecular diagnostics can pave the way for effective cancer management. In 2001, Dr Hartwell received the prestigious Nobel Prize in Physiology for his groundbreaking discovery of the universal mechanism that controls cell division in all nucleated organisms, from yeast to frogs to humans. He used yeast as a model organism to harness the tools of genetics to study how cells function and determined which genes cause cells to divide. He provided important clues to cancer as his discovery gave a new point of departure for many scientists worldwide to explore ways to stop abnormal cells from dividing." Cancer is a unique disease because mutations can distinguish cancer cells from other somatic cells. Today, DNA changes in cancer cells are being used to diagnose the risk of the disease, early detection, prognosis, therapeutic response and disease recurrence. Protein biomarkers combined with the advances in functional imaging can vastly improve the cancer management," Dr Hartford said. How medical imaging helped cancer detection over decades 1950s Nuclear medicine was introduced to treat cancer of the thyroid and diagnose thyroid. X-ray angiography introduced to understand at what stage the cancer is. Evolution of ultrasound that used high frequency sound waves to show internal tissues and organs. 1960s Nuclear medicine gains more importance as it helped to identify cancer hot spots and blood flow to the lungs. 1970s Mammography introduced to detect breast cancer. This used x-rays to detect pre-cancerous tumours. 1980s PET (Positron emission tomography) scanning introduced in 1985 helped in managing cancer better by indicating metabolic changes in tumors. Interventional radiology was introduced. This used various imaging technologies to help catheters and miniature tolls through blood vessels to deliver treatment directly to cancer site. During this decade medical imaging became an essential cancer therapy. More and more clinicians used imaging to detect tumors and manage cancers. 1990s Image guided breast biopsy and digital spot-view mammography developed. n Use of MRI and brachytheraphy for cancer gains momentum. 3-D imaging was introduced to map the tumors more effectively. 2000s Clinicians started using intensity-modulated radiation therapy that uses 3-D images from CT scans to map the cancer precisely. Computer aided diagnostics (CAD) became a reality. Clinicians started using computer algorithms to verify scans. CAD systems increase cancer detection rate by 33 percent.   After cancer, the next health concern globally is cardiovascular disease. As heart attack and stroke still remain the leading causes of morbidity and mortality worldwide, there is a huge demand for in vitro diagnostic tests that can address issues such as early diagnosis and detection of predisposing factors. Analysts predict a surge in demand for such tests in the future. Currently, this market has seen a steady growth of 12 percent, from $14 billion in 2001 to $2.2 billion in 2006. Medical imaging A key market segment of medical diagnostics that has helped tremendously in detection and treatment of cancer and CVD is medical imaging. It involves activities such as X-ray and radiography, mammography, magnetic resonance imaging (MRI), ultrasound, computed tomography (CT) scans and positron emission tomography (PET) scans. In cardiovascular diseases, imaging technologies such as ultrasound and MRI, provide high-resolution images of arteries, the vascular system, and the brain to identify blockages or the thickening of the artery lining. CT scans, diffusion-weighted imaging, and PET help physicians in assessing whether surgery to clear clogged arteries that supply blood to the brain is needed. Imaging tests also provide rapid information about the nature and location of stroke, and the extent of brain injury, thereby allowing physicians to make judgments rapidly about which treatment approach is best. The Human Genome Project and what it meant for diagnostics The Human Genome Project, the mapping of our 30,000-50,000 genes and the sequencing of all of our DNA, has a major impact on biomedical research and the whole of therapeutic and preventive health care. The tracing of genetic diseases to their molecular causes is rapidly expanding diagnostic and preventive options. Since most common diseases have been shown to be influenced by inherited variations in our genes, completion of the Human Genome Project and mapping of the human genome single-nucleotide polymorphisms will have a tremendous impact on our approach to medicine. New developments in genotyping techniques and bioinformatics, enabling detection of single-nucleotide polymorphisms, already provide physicians and scientists with tools that change our understanding of human biology. In the near future, studies will relate genetic polymorphisms to features of critical illnesses, increased susceptibility to common diseases, and altered response to therapy. Source: American Cancer Society Krishna Vilasini Bharadwaj   ]]> <![CDATA["We will be in top five, globally by 2012"]]> https://biospectrumindia.com/news/95/1877/we-will-be-in-top-five-globally-by-2012.html https://biospectrumindia.com/news/95/1877/we-will-be-in-top-five-globally-by-2012.html Mon, 07 May 2007 11:59:00 +0530 New Page 1 "We will be in top five, globally by 2012" -Malvinder Mohan Singh, CEO, Ranbaxy Led by its young CEO Malvinder Mohan Singh, Ranbaxy is in step with the changes globalization is bringing about. A blockbuster year 2006 with $1.3 billion in revenues, with international business contributing around 80 percent of the revenues, manufacturing operations in nine countries and ground operations in 49 countries have positioned the company to take advantage of the opportunities that are abound. However, ahead are challenges that involve surviving and flourishing in the highly competitive generics market. To retain the leadership, the company needs to make drug discovery and drug delivery platforms a part of the expansion agenda. All that and much more is happening at Ranbaxy, confirms CEO Malvinder Mohan Singh, in an exclusive interview with BioSpectrum. Some excerpts: What is Ranbaxy aiming at in the year 2007? With blockbuster drugs worth more than $76 billion going off patent in the next few years, the opportunity is huge. As a consequence, a large number of products will enter the market intensifying competition. The dynamics of increased life expectancy, especially in the developed countries, is further expanding the market size. Also, the governments in most markets currently have a huge healthcare deficit, which they are trying to address by restructuring healthcare expenditure, policies and infrastructure. This also adds to the market size expansion. The market for generics is very large and will continue to grow over the next 10 years. In the next few years, in the generics space, you will see consolidation on the global basis. Ranbaxy is well positioned to take advantage of this opportunity. We continue to strengthen ourselves, continuously looking at acquisitions. We will be expanding both organically and inorganically. In 2006, we closed a total of eight acquisitions across geographies including the US, Europe, Africa and India. The net profit grew by 97 percent. In 2007, we are looking ahead at having another great year. What is the company's acquisition strategy like? We work on a very well defined financial framework. For an acquisition we aim at a matrix of a good strategic fit plus the economic value the acquisition brings. No matter how good the strategic fit, it is very important for us to get a good economic value from an acquisition. We are very conscious of the fact that every acquisition is good at a certain price and becomes unviable beyond it. In 2006, we did eight good deals. Each one is in line with the objective we set out with. Today there is a greater balance between the developed markets and the emerging markets. The Terapia acquisition in Romania has given us more than a foothold in the European markets. We are investing another $20 million in Terapia Ranbaxy. A major portion of the investment will be used for boosting manufacturing and R&D capabilities in Romania. This is our strategic hub from where we will serve European and Commonwealth of Independent States countries. The story of Ranbaxy is that of a very old company keeping pace with times. Today, it is the only Asian MNC to be counted in the top 10 generics players, globally. The company was the first Indian company to have an ambition to become a global company - long before "India Inc" came into existence. However, to get any further or even to retain its leadership position, investments in R&D is a must. CEO, Malvinder Mohan Singh is well aware that R&D will be the key driver for the company in the future. Today, Ranbaxy has in place a total of three modern state-of-the-art multidisciplinary research facilities in its Gurgaon campus. While the two centers focus on the development of generics and novel drug delivery systems research, the third one is focused on the new drug discovery research. In addition to our strong organic growth, we will continue on the acquisition route to acquire capabilities that will help us reach our target of becoming a $5 billion company by 2012. To get there, we need to maintain a growth rate of 20 percent plus and we are on course as per plan. In an evolving market, to survive and flourish you need to keep pace with it and Ranbaxy is very much there. Today, we are there in top 10, globally. By 2012 we will be in top five, globally. How is your product strategy attuned to take you in top five, globally? Today, we are in a position to leverage vertical integration. Our products are available in 125 countries and we have ground presence in 49 countries. Ten years from today, Ranbaxy as a company will continue to be a strong leader in the generics space but at the same time we will also be leveraging IP that we have created by commercializing it. We are working at optimizing growth, keeping short and medium term priorities in view. We have already created a strong infrastructure boosting our manufacturing and R&D capabilities. Every year we are investing $100 million in R&D. Today, more money is going in generics than true innovation but we are working on it. The ratio of generics to true innovation investment will balance out over time. Our product strategy revolves around this. We already have a large product portfolio and we continue to expand it. We are working towards maximizing the product flow to optimize the infrastructure that we have built. We have a series of alliances through which we partner with the technical skill set needed for the purpose. We have a large number of products in various therapeutic areas, in various development stages in our product pipeline. We have high expectations from our product pipeline. Also, the financial returns from the Atovastatin launch in the US, scheduled for 2010, will help us take Ranbaxy to another level of growth. How will the generics market evolve by 2012? Drastically. Given the kind of consolidation that is happening in the space, the companies that will move up the value chain by acquiring the required competencies will emerge as leaders. In the market, currently there is expansion wherein the market has become much bigger and continues to grow yet at the same time there is consolidation as well. A number of stronger players will emerge from where we are today. There could be a number of surprises in the making. Nandita Singh   ]]> <![CDATA["We do things we are good at"]]> https://biospectrumindia.com/news/95/1754/we-do-things-we-are-good-at.html https://biospectrumindia.com/news/95/1754/we-do-things-we-are-good-at.html Mon, 07 May 2007 11:50:00 +0530 New Page 1 "We do things we are good at" -Dr Dennis Gillings, chairman and CEO, Quintiles Transnational Corp Quintiles Transnational Corp is powering the next generation of healthcare, providing a broad range of professional services in drug development, financial partnering and commercialization for the biotechnology and healthcare industries. Set up in 1982 with 10 employees by Dr Dennis Gillings, a professor of bio statistics at the University of North Carolina at Chapel Hill, it now has 18,000 employees and offices in more than 50 countries with revenues of $2 billion. With nearly 30 years of experience in drug development applications and theory, Dr Gillings has been a consultant for a number of companies and health organizations including the National Cancer Institute, the National Institute for Dental Research and the Institute of Medicine. A recipient of the Commander of the British Empire (CBE), Dr Gillings began providing statistical consulting and data management services to pharmaceutical clients in 1974 during his tenure as professor. Dr Dennis Gillings, who was in India to dedicate the Quintiles' new central lab in Mumbai, spoke to BioSpectrum about the organization and trends in the CRO sector. Excerpts of the interview: What are the factors that has made Quintiles a global leader? About 7-8 years back, I had difficulty in putting together a management team in place for a new global and larger company. In the last three to four years, I believe I have assembled an excellent management team by bringing people from other industries and this was a difficult task. We have done it and it is now paying dividends. So I am pleased with that. We make sure that we don't make things where we are not good in. We do things we are good at. Are you looking for inorganic growth? Not really because we have presence in all countries. When you do acquisition, you have to integrate with them. And this can be disruptive to services organizations. We being in a good position, do not need to go through the difficult steps because we are present in all the countries. How do you see your position in the third world or developing countries like India where leading companies are now making a beeline to set up CROs? We are the leaders in our business in almost all the developing countries. So we would probably do acquisition if people overtook us. Now there is no room for us to look at that when we are a leader and in a comfortable position. We don't have to do so many acquisitions. If two of our big competitors combine, then we could think about it. That could be actually good for us because they have to go through the integration processes. It's harder to integrate services business than the product business. Why did you look at India in 1997? It was an obvious choice. India is going to be major economy. And it is not just because of this. When a country has over $1000 on a person of the GNP and spends it on healthcare by buying pharmaceuticals, it builds the pharmaceuticals industry. And at the same time, the General Agreement on Tariffs and Trade (GATT) talks were going on. India signed the TRIPS agreement. I got the sense that India is the best bet to participate in CRO sector. And also post 1990, India changed from being the internal focused economy to more externally focused economy. These things made me to stay well with one sixth of world population in India.. You have presence in both India and China. Which country do you feel gives better RoI? India has been much better for us. The business in India is much bigger than in China. It is easy to do business in India because of the English-speaking people, which makes communication easy and strong leadership in India. What made you look at China despite many drawbacks? China also has large population. We want to be where our customers want us to be. To be honest, we went to China because of the customer demand and came to India because I thought it is a good idea. And no customer demand encouraged us to come to India. I felt India could be very good for our business. What is India's contribution to Quintiles total sales of $2 billion? At the moment India's contribution is about 3 percent. But it is very large. It is growing at over 30 percent CAGR. So I expect India will get about 5 or 6 percent in the next five years or so. What are the issues that need government attention? I think it could be good if there could a parallel process of getting the clinical trials established in India and at the same time in America. The regulatory group at the ministry of health is very receptive. However, the local experts will be able to give a clear picture on starting a site in India at same time as in New York. My understanding is that it has to be started in New York before we could make applications here in India. Narayan Kulkarni   ]]> <![CDATA["Clients are more at ease with CROs which have multi-region presence"]]> https://biospectrumindia.com/news/95/2088/clients-are-more-at-ease-with-cros-which-have-multi-region-presence.html https://biospectrumindia.com/news/95/2088/clients-are-more-at-ease-with-cros-which-have-multi-region-presence.html Mon, 07 May 2007 11:30:00 +0530 New Page 1 "Clients are more at ease with CROs which have multi-region presence" -DA Prasanna, vice chairman and MD, AcuNova Life Sciences AcuNova Life Sciences, a subsidiary of Bangalore-based Manipal AcuNova Ltd, has entered into a strategic collaboration with Kiecana Clinical Research (KCR), based in Warsaw, Poland, for leveraging operations in South Asia, Europe and Latin America. This alliance has resulted in the formation of a regional expert CRO aimed at quality clinical trials conducted on time, at competitive costs. The alliance will focus on therapeutic areas like oncology, cardio-vascular, endocrinology and neurology. This is an innovative alliance. DA Prasanna shares his view points on the benefits that accrue through such collaborations. What is the scope of this alliance? A team of over 250 professionals including 39 MDs and 12 PhDs will bring their insight into disease prevalence and standards of care and building quality for clients. The alliance will focus on phase I-IV trials, combining the geographic knowledge of sites and investigators with therapeutic expertise. India, East Europe and Latin America today have become key destinations for speedy recruitment into trials at competitive cost. And AcuNova-KCR alliance will deliver quality, speed and cost advantage across the three most exciting regions. India has emerged as the leader in generics and software. The alliance will offer clients high quality data management and biostatistics service, as well as conduct of PK/PD studies What are the benefits of forming a regional expert CRO? This global alliance aims at increasing patient recruitment in newer regions like East Europe for AcuNova clients and South Asia and Latin America for KCR clients. Further, while AcuNova would get access to the patient population in Central and Eastern Europe (470 million) and Latin America (200 million), KCR would get access to India (1.2 billion), enabling both companies to maintain the highest standards and comply with global mandates. Besides, AcuNova will get FDA submission expertise and KCR will gain from the CDM and biostatistics capabilities. The collaboration will add value to clients who wish to expand their trials and to newer markets, thereby increasing speed and reducing risks. How will AcuNova gain from the alliance globally and in India? International clients are more at ease with CROs that have multi region presence and offer end-to-end service. We are able to address this need, with KCR, a highly reputed CRO in Central and East Europe. KCR's regional expertise combined with its strength in FDA submissions is a new form of alliance for our industry and we are excited about this. What is India's advantage through such collaboration? This alliance will establish the beginning of a new form of alliance-the formation of a regional expert CRO.   Ch.Srinivas Rao SIRO Clinpharm bags award The Partner of Choice Awards 2007 instituted by Frost & Sullivan, recognizes the best Indian research and manufacturing services capability in life sciences and assesses its global competitiveness. "The facilities that were commended as award recipients are those who have achieved and sustained excellence in their industry value chain component with the diligence, perseverance, foresight and dedication required to develop a successful organization and sustain continuous learning to be the true Partners of Choice" said Mahesh Sawant, program manager, biotechnology and life sciences, healthcare practice, Frost & Sullivan. The award recipients include: Partner of Choice in Contract Research-Chemistry Based Services: Research Support International Ltd Partner of Choice in Contract Research-Collaborative Drug Discovery: Orchid Research Laboratories Ltd Partner of Choice in Contract Research-Preclinical Safety Assessment: Jai Research Foundation Partner of Choice in Clinical Research-Phase I Studies: Veeda Clinical Research Private Ltd Partner of Choice in Clinical Research-Phase II to IV Studies: SIRO Clinpharm Pvt Ltd Partner of Choice in Clinical Research-Data Management Services: Cognizant Technology Solutions Partner of Choice in Clinical Research-Data Central Laboratory Services: SRL Ranbaxy Partner of Choice in Bioavailability/Bioequivalence Studies: Manipal AcuNova Partner of Choice in Contract Manufacturing-Oral Solid Dosage forms: Nicholas Piramal India Limited Partner of Choice in Contract Manufacturing-Sterile Dosage forms: Nicholas Piramal India Limited "This is a proud moment for all of us at SIRO. I hope we continue to achieve more and more awards and success in future. We believe our clients are in a race to bring the best possible cures to diseases afflicting mankind. It shall be our constant endeavor to support and facilitate them to win the race in the shortest time, best ethics and highest safety," said Chetan Tamhankar, chief operating officer, SIRO Clinpharm Pvt Ltd.   ]]> <![CDATA[Indian CROs eyeing a lion's share]]> https://biospectrumindia.com/news/95/7177/indian-cros-eyeing-a-lions-share.html https://biospectrumindia.com/news/95/7177/indian-cros-eyeing-a-lions-share.html Mon, 07 May 2007 11:19:00 +0530 Indian CROs eyeing a lion Indian CROs eyeing a lion's share With increasing outsourcing activities, opening up of the market and government initiatives, Indian Clinical Research Organizations (CROs) are making efforts to strengthen their base and to have a bigger share of the pie in the big and growing CRO market. Over a period of 14 years, as many as 70 independent players including healthcare, information technology and pharma companies started offering services and solutions in clinical research and trials space to MNCs. The top Indian CROs have the backing of the leading pharma companies that supported them during the initial period. And those who are offering data management services include Indian IT giants like HCL, Cognizant, TCS, Satyam and Infosys. The competition has increased with too many players in the space. To have an edge over the others and to meet the requirements of the sponsors, the CROs have been applying for certifications and accreditations. There are many agencies that audit the organizations and provide them with accreditations/certifications. Most the leading names in the CRO space already had many certifications and accreditations from agencies like UK-MHRA, Brazil-Anvisa and Israel-MOH. In the recent past, many other CROs too received certification. Manipal AcuNova, the first Indian CRO to be ISO 9001 certified, has received NABL accreditation to its central reference laboratory at Bangalore. The ISO 15189:2003 accreditation has been given by the department of science and technology (DST) for diagnostic testing. In one year, Manipal AcuNova has completed the certification process for two of its laboratories. Manipal AcuNova's central reference laboratory specializes in patient testing, advanced molecular diagnostics and clinical trial testing. Similarly Glenmark Pharmaceuticals, a leading pharma company that has a clinical research division, has got regulatory approval from the Brazilian authorities ANVISA (AgÃªncia Nacional de VigilÃ¢ncia SanitÃ¡ria) to conduct bioavailability and bioequivalence studies in human volunteers. Its clinical research unit is located at Turbhe, Navi Mumbai and accommodates about 72 volunteers. It also has developed a phase I unit equipped with eight beds to conduct phase I human volunteer studies. Regulatory submissions have also been made to the US and the European Union from this facility. Another CRO, Lambda Therapeutic, with 160-bed phase-I units (increasing it to 260 beds) and own central reference lab for clinical and bioanalytical evaluations, has became the country's first level National Glycosylation Standardisation Program (NGSP) certified lab for glycosylated hemoglobin (HbA1C). NGSP standardizes HbA1C test results so that lab results are comparable to those reported in Diabetes Control and Complications Trial (DCCT) where relationships to mean blood glucose and risk for vascular complications have been established. About five Indian organizations (three CROs-Clinigene, Lambda and IGate Clinical Research and two pathology labs-Dr Lal Pathlabs and SRL Ranbaxy) have received the CAP (College of American Pathologists) accreditation. Clinigene is the first to get this in the CRO space while SRL Ranbaxy became the first pathology laboratory to be accredited by the College of American Pathologists. New initiatives Considering the growing market in CRO space the healthcare companies are making inroads into CRO business. Fortis Healthcare group, a flagship firm from Ranbaxy has started its own clinical research services company under the banner Fortis Clinical Research Ltd (FCRL). It has a state-of-the-art facility located within the Sunflag Hospital & Research Centre in Faridabad near Delhi. The infrastructure consists of a 78-bed ward and sophisticated bioanalytical labs with LC/MS machines spread over 19,000 sq ft area and manned by 50 professionals. The current services include bioequivalence studies, clinical pharmacokinetics, bioanalytics, and CAP-accredited central laboratory support for Phase I-III clinical trials. The facility is GCP compliant and approved by DCGI (India) and ANVISA (Brazil). Dr Lal PathLabs, a leading medical diagnostics company with turnover of Rs 100 crore, too has launched its clinical research services by opening a dedicated state-of-the-art clinical trial laboratory (central lab). It has set up the 4,000-sft facility at Gurgaon exclusively for clinical trial operations. And it is also setting up a mega 65,000 sft laboratory at Rohini in North Delhi, which is expected to be in place by 2008. On the other side, Synchron Research Services has expanded its operation in India by acquiring Innovance, a local start-up CRO having a world-class clinical research facility in Ahmedabad. This acquisition provides Synchron an additional facility which offers internationally accepted clinical research services. The new clinical facility has totally 200 beds across Asia. This makes Synchron one of the largest Asian CROs. In addition to this, Synchron is building a 32,000 sft facility exclusively for bio-analytics and data management, which would be ready by August. It has also entered into a tie-up with HCL Technologies for clinical trial solutions. This initiative from HCL will become end-to-end solution provider to clinical trials and data management companies. It also partnered with Parexel, a leading International CRO in 2006. ICRI Research (P) Ltd (IRL), an associate company of the Institute of Clinical Research India (ICRI) the clinical research institute offering courses in clinical research, has entered into a collaboration with UK-based Synexus Clinical Research plc, a patient recruitment SMO (Site Management Organization) to establish a chain of dedicated, GCP-compliant clinical research centers in India. IRL-Synexus will offer dedicated investigator sites (clinical research centers) for phase IIâ€“Phase IV clinical trials. Looking at the potential and opportunity in the CRO space, WellQuest, a division of Nicholas Piramal India Ltd (NPIL), is doubling its present capacities and expanding its activities to Hyderabad. Similarly, Mumbai-based ClinWorld, the clinical research arm of the Sami Labs, will be investing Rs 30 crore in the next three years to strengthen the existing facilities in Mumbai and Bangalore. Even Reliance Clinical Research Services, a subsidiary of Reliance Life Sciences that has set up its US entity, will be adding more staff. By end of 2007, it is expected to touch 500 personnel in Mumbai and Bangalore in addition to the functional leaders located in the US and EU. Investments from VCs The Indian CRO segment has been growing in the terms of number of companies. The segment will get a boost because of more outsourcing activities. India has witnessed new entrants from local players to global CRO giants. To offer better services and to deliver within timelines, which is a key parameter for a good CRO, the organizations have to expand their operations in all parameters like headcount, services and infrastructure. To fulfil such many other requirements, the CROs need funding. Venture capitalists, institutional bankers and the private equity partners are eager to fund these growing CROs considering the low risks and high growth potential. A few such investments from the VC community have happened in the recent past. Acording to an US-IVCA/Venture Intelligence study, VCs have made four investments worth $16 million in the healthcare and life sciences industry during 2006 of which which three are in the CRO space. Barings Private Equity Partners has bought a stake in Siro ClinPharm for an undisclosed sum. The stake is estimated to be less than 30 percent. ICICI Venture Fund has picked up minority equity in diagnostics-chain Metropolis Health Services for Rs 35 crore. IL&FS Investment Managers has invested Rs 45 crore by picking up a minority stake in Manipal AcuNova. Aureos India has invested about Rs 18 crore in Accutest Research. Government support According to the BCG report, the CRO market growth is expected to be double digit in the next five years. India has a record of conducting clinical data management and biostatistics work for MNCs. It is expected to get major share of such work in near the future too. At present India conducts about 1.5 percent of the global clinical trials. This could rise to five percent by 2008 and 15 percent by 2011. And that is the percentage of a global total that itself is increasing by 10 percent every year. To support this growing service sector, in its recent Budget, the Central government announced exemption of service tax for CROs. The industry welcoming the initiative, noted that it will bring more customers to India and also more companies would start operations in this area. The government has also committed $1 million fund to upscale the capacities and competence of the country's clinical research organizations. The DBT and the Indian Council of Medical Research are supporting this fund. Besides the financial support, the ministry of health and family welfare has constituted the National Council for Clinical Establishments under the directorate of health services with a view to determine minimum standards for clinical establishments and to maintain and update a national register of clinical establishments in the country. The director general of health service, ministry of health and family welfare, will head the council as chairman. The functions of the National Council for Clinical Establishments shall be to determine the standards for clinical establishments; classify the clinical establishment into different categories; develop the minimum standards and their periodic review; compile, maintain and update a national register of clinical establishments; perform any other function determined by the Central government from time to time. Future ahead The Indian CRO market is expected to undergo a composition change in the coming few years. Bioavailability and bioequivalence studies that occupied a major share in the clinical research market pie, are likely to lose to other areas such as clinical trials (phase I-IV) and data management. The cost advantage will no longer be the prime-attracting factor for the Indian players. The importance would shift to factors such as quality, timeliness, and value added services that are being offered by the Indian CROs. However, data security, manpower and public infrastructure still act as roadblock or a potential drawback for the growth of the industry. And also the issue of the lag for phase I trials in India. But Frost & Sullivan noted that the nascent markets like phase I and pre-clinical toxicology will see growth due to the pressure from the industry on government and the industry's need to become a one-stop solution for its clients. Once that is in place, Indian CROs can increase their share in the global CRO market. Investments in CROs Barings Private Equity Partners bought a stake in Siro ClinPharm ICICI Venture Fund picked up equity in Metropolis Health Services IL&FS Investment Managers invests in Manipal Acunova Aureos India invests in Accutest Research   Trends in CROs The full services CROs are seeing a downward shift in preference by the big players who are now focusing on functional experts to leverage the cost ad vantage further. The growth rate of this market is on an upward trend BA/BE studies occupy a major chunk of the market. However, it is forecasted that this segment of clinical research would slowly decrease in terms of total contribution to the market pie over the forecast period (2006-13), as conse quence of growth in other segments of clinical research. Most of the participants in these segments offer a gamut of services and are moving towards becoming a one-stop solution for their sponsors China, India, Vietnam and Thailand are emerging as preferred destinations Source: Frost & Sullivan CRAMS report 2007   CROs having strong support of parent group IGATE Clinical Research International is backed by IGATE Solutions Integrated Clinical Research Sciences is backed by Wadia Group Reliance Clinical Research Services is backed by Reliance Industries Jubilant Clinsys is backed by Jubilant Organosys Lambda Therapeutic Research is backed by Intas Pharma Manipal Acunova is backed by Manipal Group SIRO ClinPharm is backed by Bharat Serums and Vaccines Fortis Clinical Research is backed by Ranbaxy and Fortis Healthcare Clinigene International is backed by Biocon India Lotus Labs is backed by Actavis WellQuest is backed by Nicholas Piramal India Ltd (NPIL) Ace Biomed is backed by Geochem group of companies BioArc Research Solutions is backed by Alembic Ltd Neeman Medical International is backed by Max India Ltd   Opportunity areas Central labs, Clinical services, Clinical trials supply management Biomarkers identification and validation Source: Frost & Sullivan   Destination India Quality: conformance to ICH & GCP quality guidance Speed: patient enrollment rates for a phase III study could be up to 6 times higher in India than in the US/Europe Technology: advantage of India's IT strengths for data management Disease profile: high incidence of infectious and lifestyle diseases Investigators: excellent pool of qualified and trained doctors and physicians Genetic diversity: highly heterogeneous population Ethics: efficient patient consent system           Source: IBEF report on biotechnology   India: a favorable environment - medical infrastructure Hospitals: 14,000 Doctors: 5,00,000 Hospital beds: 7,00,000 (85 percent urban) Medical colleges: 162 Medical graduates: 17,000 every year Source: Burrill India Life Sciences Newsletter October 2006   India patient population estimates 40 million asthmatic patients Approx 34 million diabetic patients 8-10 million people HIV positive 8 million epileptic patients 3 million cancer patients >2 million cardiac related deaths 1.5 million patients with Alzheimer disease 15 percent population is hypertensive 1 percent of population suffers from schizophrenia Source: Burrill India Life Sciences Newsletter October 2006     ]]> <![CDATA[India, a rising star in contract and clinical research]]> https://biospectrumindia.com/news/95/7445/india-a-rising-star-in-contract-and-clinical-research.html https://biospectrumindia.com/news/95/7445/india-a-rising-star-in-contract-and-clinical-research.html Mon, 07 May 2007 11:17:00 +0530 New Page 1 India, a rising star in contract and clinical research The outsourcing of drug discovery research to India is on the rise. The pharma outsourcing business in India will grow to around $7 billion (Rs 28,700 crore) by 2013, according to research firm Frost & Sullivan. Another report by Pune-based research firm Value Notes, forecasts a growth of 23.6 percent annually for the industry up to 2010. This is not a hype or hope, but a reality as global firms seek to leverage the advantages related to cost and quality that Indian companies offer in this field. According to the Frost & Sullivan study, the Indian Contract Research and Manufacturing Services (CRAMS) market in India was valued at $895 million in 2006. Though manufacturing (Active Pharma Ingredients or APIs) and oral solid formulations (tablets and capsules) continue to be the major sources of revenue for India's contract manufacturing industry, other segments in contract research, outsourcing of drug discovery research are slated to show the highest growth of 26 percent a year, according to the Value Notes report, Contract Research Opportunity for the Indian Pharmaceuticals Industry. The signs of this trend are clearly visible with several multinational companies such as GSK and Bristol-Myers Squibb Co. tying up with Indian companies for both drug development and manufacturing services. GlaxoSmithKline (GSK) signed a multi-million dollar contract with Tata Consultancy Services (TCS) to establish a global drug development support center in Mumbai to help meet the demands of the growing GSK pipeline. Bristol Bristol-Myers Squibb Co. and Biocon's Syngene have signed a research collaboration agreement. Further, several Indian companies are also forming alliances or acquiring companies outside the country to enhance their capabilities and service offerings. For example, Manipal AcuNova's AcuNova Life Sciences has formed a strategic regional alliance with Kiecana Clinical Research (KCR), based in Warsaw, Poland, for leveraging operations in South Asia, Europe and Latin America. The objective of being globally competitive and seeking a symbiotic relationship is to facilitate their respective clients to bring out quality products in a short time. BioSpectrum brings to you the story of the rise of the CROs in the ensuing pages.   ]]> <![CDATA[United Front at BIO Boston]]> https://biospectrumindia.com/news/95/5563/united-front-at-bio-boston.html https://biospectrumindia.com/news/95/5563/united-front-at-bio-boston.html Tue, 10 Apr 2007 13:12:00 +0530 New Page 1 United Front at BIO Boston It is heartening to note that the Indian biotech industry is going to present a united front at the forthcoming BIO event in Boston in early May. Industry leaders from different segments of biotech have welcomed the effort of DBT in organizing what may probably be the largest ever biotech business delegation to the world's largest biotechnology event. Many of the suggestions from industry leaders highlighted by BioSpectrum after the last event have been incorporated into this year's planning for BIO. Other friends of the country, like the Indo-US Chamber of Commerce too have pitched in by organizing a high-profile event on May 7 at Boston to bring policy makers and CEOs from both the countries face-to-face to understand and promote biotechnology. Over 40 companies and research organizations and trade promotion agencies will participate in the India Pavilion at BIO this time. There is still time to expand the participation by providing opportunities to some of the new entrepreneurs to use this platform to showcase their skills and catch the attention of global biotech leaders. The global biotech industry had turned its focus to biofuels in the last 12-18 months, sensing the opportunity offered by the rising prices of petroleum-based products. In fact, this was the theme at BIO Chicago in 2006 and since then considerable progress has been made in tapping alternate sources of fuel using biotechnology to keep the global economy chug along the growth path without "oil shocks." At the same time, biofuels such as ethanol, produced from agricultural products like corn have come under increasing opposition from environmentalists. There has been a decrease in global foodgrain stocks and prices have been soaring across the board. Environmentalists have been blaming the surging demand for alternate fuels based on agricultural products for the looming shortage of foodgrains around the world. Countries like India have avoided getting into this trap and as a special report in this issue indicates, Indian companies are extracting biodiesel from made-to-order crops like jatropha and pongamia in vast stretches of wastelands. India has mandated a five percent blend of biodiesel with the conventional diesel and the industry will need some fiscal and other incentives to achieve this goal by 2010. Shortage of raw materials is a major concern. Though more fuel-bearing crops can be grown, the absence of sufficient processing plants in these areas seems to be hampering the growth of this sector. This should give some food for thought to the policy makers. Meanwhile, the country's biotech teaching institution (ranked by the BioSpectrum Top 20 BT Schools Survey), the Rajiv Gandhi Center for Biotechnology in Thiruvananthapuram , is in the throes of an administrative crisis. The transfer of this Kerala-government promoted center to the Central government to be bestowed the status of a National Institution to avail the Rs 50-crore special grants announced in February 2006, has been stalled due to a political row within the Kerala government. There are also allegations that a section of the state bureaucracy has undermined the efforts of the state chief minister's decision to transfer the institution to the Central government's control. It will be in the industry's and nation's interest to resolve this issue at the earliest so that this excellent institution can continue with its futuristic mandate, undeterred by administrative issues. <sureshn@cybermedia.co.in> ]]> <![CDATA[Awards galore at DBT Foundation Day]]> https://biospectrumindia.com/news/95/2240/awards-galore-at-dbt-foundation-day.html https://biospectrumindia.com/news/95/2240/awards-galore-at-dbt-foundation-day.html Tue, 10 Apr 2007 13:08:00 +0530 New Page 1 Awards galore at DBT Foundation Day On March 12, 2007, a series of awards were announced to honor researchers, scientists working in the sciences arena. The Distinguished Biotechnologist Award for the year 2006 has been conferred on Prof. TP Singh for his outstanding contributions in structural biology. Prof. TP Singh headed the Biophysics Department at the All India Institute of Medical Sciences, New Delhi during 1986â€“August 2006. He obtained his PhD from the Indian Institute of Science, Bangalore in 1975 on structureâ€“function studies of analgesic/anti-inflammatory agents. He has made original and novel contributions to the structural studies of proteins and implemented a strong program on structure-based rational drug design. Significantly, Prof. TP Singh has developed a new program on Clinical Proteomics at AIIMS in collaboration with other faculty members to characterize all the proteins that are expressed during various patho/physiological conditions. His group has already determined more than 50 structures of proteins and their complexes under this program. Dr Manju Sharma, former secretary, DBT, has been honored with the National Award for Senior Woman Bioscientist for the year 2006 in recognition of her vision and incessant efforts in shaping and steering research in biotechnology and new biology and for applying research results for the benefit of the society in the country. The National Award for Young Women Bioscientists for the year 2006 was conferred on Dr Gagandeep Kang, CMC, Vellore and Dr Ramanathan Sowdhamini, NCBS, Bangalore. Dr Gagandeep Kang has been honored for her significant contributions on rotaviral diarrhoeal diseases in children particularly on molecular epidemiology. She is presently working as Professor of Microbiology in the Department of Gastrointestinal Sciences, Christian Medical College, Vellore. Dr Ramanathan Sowdhamini is presently working as Associate Professor at National Centre for Biological Sciences (TIFR), Bangalore. She received the award for her significant contribution for the development of sensitive tools for accurate structure and function of proteins The National Bioscience Award for Career Development for the year 2006 has been also awarded to several young scientists working in basic and applied research covering all the areas of biosciences and biotechnology. These include: Dr Sanjeev Galande for his significant findings on dynamic changes in higher order chromatin assembly which governs gene expression in a spatial and temporal manner. Dr Galande is presently working as Scientist D at the National Centre for Cell Science, Pune. Dr Kumaravel Somasundaram for his significant contributions in the field of eukaryotic cell transformation and for understanding the pathways for regulating cell growth and death in normal and cancer cells. Dr Somasundaram is presently working as Associate Professor in the Department of Microbiology and Cell Biology, Indian Institute of Science, Bangalore Dr Javed Agrewala for his outstanding contributions in understanding the co-stimulation of T and B lymphocytes and for establishing a novel and simple vaccination strategy utilizing infected macrophages. Dr Agrewala is presently working as scientist E I at the Institute of Microbial Technology, Chandigarh. Dr G Taru Sharma for her significant contributions in functional genomics of the pre-implantation buffalo embryos. Dr. Sharma is presently working as Senior Scientist at the Indian Veterinary Research Institute, Izatnagar. Dr Pramod P Wangikar for developing a strategy for modeling, optimization and monitoring of fermentation and for selecting the strains of industrial importance. Dr. Wangikar is presently working as Associate Professor at Department of Chemical Engineering, Indian Institute of Technology, Bombay, Mumbai. Dr Ajay Parida for his outstanding contributions in the area of characterization of genetic resources and enhancement of coastal ecosystems using modern biotechnological tools. Dr Parida is presently working as Program Director (Biotechnology) at the MS Swaminathan Research Foundation, Chennai. Dr Pradeep Kumar for his significant contributions in the area of sperm-oocyte interaction and gene expression in testis. Dr Kumar is currently working as a Scientist-F at Rajiv Gandhi Centre for Biotechnology, Thiruvananthapuram. 12 scientists were given away Innovative Young Biotechnologist Awards on the occasion. They include: Dr Yamuna Krishnan, NCBS, Bangalore; Dr Sneh Lata Singla-Pareek, ICGEB, New Delhi; Dr Mrinalini Jayant Puranik, NCBS, Bangalore; Dr Madhusudan R Nandineni, CDFD, Hyderabad; Dr TR Santhosh Kumar, RGCBT, Thiruvananthapuram; Dr Mukesh Jain, University of Delhi (South Campus), New Delhi; Dr Madhulika Dixit, Madras Diabetes Research Foundation (MDRF), Chennai; Dr Rupinder Kaur, CDFD, Hyderabad; Dr V Sriram, NCBS, Bangalore; Dr Samudrala Gourinath, JNU, New Delhi; Dr Manjula Kalia, NCBS, Bangalore; and Dr S Swaminathan, SASTRA, Thanjavur.   ]]> <![CDATA[Mixed-mode sorbents provide options for protein purification]]> https://biospectrumindia.com/news/95/2097/mixed-mode-sorbents-provide-options-for-protein-purification.html https://biospectrumindia.com/news/95/2097/mixed-mode-sorbents-provide-options-for-protein-purification.html Tue, 10 Apr 2007 13:00:00 +0530 New Page 1 Chromatography Advisor # 6 Mixed-mode sorbents provide options for protein purification New environmentally friendly, mixed-mode chromatography sorbents from Pall Corporation improve efficiency and economics of drug manufacturing. Drug manufacturers have made improvements to upstream protein production, but the greater yields have created challenges for downstream purification processes. To avoid bottlenecks, the choice of chromatography method is critical. This advisor takes a look at new "mixed mode" chromatography sorbents that combine hydrophobic and ionic components, making them useful for a range of approaches to protein purification. Unlike many sorbents used in hydrophobic interaction chromatography, they do not need to be used with significant quantities of salt additives-potentially increasing the efficiency of purification processes while reducing costs and the environmental impact of salt disposal. To meet the growing demand for protein-based therapies, drug manufacturers have adopted technologies that have improved upstream biopharmaceutical production. But the resulting increase in yields has created challenges for downstream purification processes: more biomass means that there is more product, often at higher concentrations, that needs to be purified. Chromatography is one of the biopharmaceutical industry's most efficient and versatile methods for production-scale separation and purification. Recently some new tools have been added to help manufacturers select the optimum separation conditions to capture a target protein or resolve impurities. New, mixed-mode chromatography sorbents offer unique advantages to drug manufacturers by adding new chromatography selectivities that simplify the process of protein purification. Phenylpropylamino (PPA) and Hexylamino (HEA) HyperCel mixed-mode sorbents can be used in a range of approaches to purification since they combine hydrophobic and ionic components. Unlike conventional hydrophobic interaction chromatography (HIC), these sorbents do not require salt additives. Based on a proven bead matrix currently used in production of clinical material for late-stage clinical trials, these new sorbents bring versatility to purification processes. Though they are new to the market, research shows that they have the potential to increase protein yield by preserving protein purity. And, because they eliminate the need to use salts, they may help to reduce costs and ameliorate environmental concerns related to recycling and disposal. Versatility of mixed-mode sorbents Proteins vary enormously in their properties, making it essential for drug makers to have a range of tools at their disposal to exploit these differences in separation and purification processes. PPA and HEA sorbents each combine the characteristics of HIC and some ion exchange features, providing a novel mechanism of mixed-mode separation that can work for a range of processing applications where conventional methods are not effective. HIC, commonly used for large-scale purification of biopharmaceutical products, is a technique for purifying and separating molecules based on differences in their surface hydrophobicity, or the physical property of molecules that are repelled by water. In an HIC process, the removal of water molecules during binding and elution is effected by adding lyotropic salts, such as ammonium sulphate or sodium sulphate, often in concentrations up to 2M. With such high concentrations of salt, the solubility of the proteins drops sharply, and the proteins precipitate out of the solvent. FIGURE 1: PPA and HEA HyperCel - Effect of temperature on protein binding Protein binding capacity increases with increasing temperature. This indicates a hydrophobic interaction adsorptive process even in the absence of lyotropes. But utilizing this much salt introduces challenges. In addition to purchasing significant quantities of reagent salts, processors are required to follow regulations for their disposal after the adsorption and wash stages. In large-scale production, this recycling can add significant costs and have a negative environmental impact. High concentrations of salt also create issues related to the chromatography equipment and columns. In an IEX process, proteins are isolated based on their charge at a certain pH. This is a useful technique in the final stages of a purification process-sometimes referred to as the "polishing" of the product-as well as in the capture and intermediate stages. Combining dominant "low-salt" hydrophobic binding mechansism with some ion exchange properties the new chromatography sorbents can be "fine-tuned" to capture proteins or discriminate between impurities based on differences in relative hydrophobicity and isoelectric points. The purified proteins can be recovered in dilute buffer, or buffer of moderate conductivity. This mechanism applies to a broad range of proteins, including monoclonal antibodies (MAbs), enzymes, vaccines, recombinants, and plasma fractions. Because the sorbents are based on a mechanically and chemically stable matrix, they can be easily packed and unpacked in columns and operated at flow rates up to 1,000 cm per hour. The sorbent can also withstand repeated harsh alkaline treatments (1 M NaOH during 200 cycles) for effective sanitization and cleaning in place. Used in a resin screening process, PPA & HEA HyperCel sorbents offer an addition to the process chromatography purification toolbox: an alternative or orthogonal option to well-known methods such as ion exchange. Effectiveness, without salt additives A recent study evaluated the binding and elution properties of PPA and HEA sorbents with a variety of proteins. It compared the properties of these mixed-mode sorbents with those of anion exchange, HIC, and hydrophobic charge induction chromatography (HCIC) sorbents. Tests have demonstrated a distinct selectivity of the new sorbents compared with the other methods. Data show that the new sorbents have superior binding capacity in physiological (0.14 M NaCl) buffers like PBS, compared with conventional HIC sorbents. For example, they demonstrated a binding capacity of about 50mg/ml for BSA, compared to less than 2 mg/ml for conventional HIC resins under similar low-salt conditions. The sorbents also proved capable of interacting with a range of proteins. Typically, protein binding is simply achieved in PBS at pH 7.4, without addition of salt, and elution is obtained by pH decrease, in a gradient or a step-elution mode (i.e. pH 7.4 to pH 3.0). The study found that the process binding capacity increased as temperature increased (Figure 1), indicating that a hydrophobic interaction adsorptive process was taking place, without the addition of lyotropic salts. This research shows that, under certain conditions, these new sorbents can provide a greater yield and recovery of protein products. Their effectiveness and versatility can help streamline the purification stages of drug processing, potentially reducing the costs of downstream production. They offer an additional process purification tool by bringing distinct selectivities to capture protein or resolve impurities. As an alternative approach to conventional HIC, this "no-salt/low-salt" capture option minimizes the risk of protein aggregation and recovery loss, and it provides an environmentally-friendly method that can contribute to the overall reduction of purification costs, with no waste recycling. Ian Sellick, Marketing Director, Pall Corporation/BioPharmaceuticals Note: This article has earlier appeared in Bioprocess International   ]]> <![CDATA[Bio Suppliers News]]> https://biospectrumindia.com/news/95/1328/bio-suppliers-news.html https://biospectrumindia.com/news/95/1328/bio-suppliers-news.html Tue, 10 Apr 2007 12:53:00 +0530 New Page 1 Fidelity buys 5% stake in Ess Dee Aluminium Fidelity International has picked up five percent equity in Ess Dee Aluminium, one of India's leading provider of pharma packaging solutions. The fund has invested close to Rs 40 crore in the company's stock that pegs its enterprise value at around Rs 800 crore. Confirming the development, Sudip Dutta, CMD, Ess Dee Aluminium, said, "It is a reflection of the confidence that global financial institutions are showing in the company," he said adding that other funds, including Blackstone, have evinced interest to be a part of Ess Dee. "ICICI and Marc Faber, the famous Asian financial commentator, already hold around 3.5 percent and 4 percent equity, respectively, in Ess Dee," he said. The other investors include Nimesh Kampani and Jagdish Master of Enam. The Rs 130-crore Ess Dee Aluminium has an ambitious growth agenda. The company is planning to invest $40-45 million to set up a plant in Dubai and also looking to acquire a company in South Africa. Ess Dee has recently set up a plant in Sikkim, which is offering tax benefits and now, company is looking at expanding overseas. Overseas expansion will be funded partly through internal accruals and if need be, the company may consider FCCB route. Enthused by a fast-growing pharma and the FMCG packaging market, Ess Dee has been on a capacity ramp up mode during the past one year. Ess Dee Aluminium has already invested over Rs 100 crore in setting up a thermo forming films plant for the pharmaceutical industry in Daman. The new plant will also offer cost-effective aluminium foil-based laminates to food and FMCG sectors. Many products that Ess Dee intends to make are import substitutes and will facilitate expansion of usage. The company faces a situation where demand for packaging products outstrips supply. Fresh capacities are needed to wipe out the backlog.   Praj bags Rs 65 crore contract from Belgian firm Praj Industries has bagged the second phase contract for the wheat and beet based bio-ethanol plant for Biowanze SA, a subsidiary of CropEnergies AG (a Sudzucker Group Company), through De Smet SA Engineers & Contractors, EPC contractor engaged by Biowanze for the project. The contract value is close to Rs 65 crore (â‚¬11.502 million). The second phase involves supply of equipment for the core bio-ethanol process plant comprising liquefaction, fermentation, multi-pressure distillation, dehydration and vinasse evaporation. The â‚¬5.4-billion Sudzucker Group, with 44 sugar factories spread across Europe, is the largest sugar producer in Europe. CropEnergies AG is also one of the leading producers of bio-ethanol in Europe. The contract in the first phase included license, basic engineering and other services for their proposed 300,000 cubic meters bio-ethanol complex at Wanze in Belgium. The first phase of the order value was â‚¬2 million (approximately Rs 11 crore), a press release said. Anil Deshpande, president, European operations, Praj Industries, said, "Europe is experiencing growth in ethanol plant installation. Praj has already made headway in the European ethanol Industry with orders from British Sugar and Suedzucker Group in Western Europe as well as from companies in Eastern Europe for technology and critical equipment. Going forward, we see a lot of potential, particularly in light of the recent endorsement of the Biofuels Policy by the European Council."   Shimadzu to expand its India operations Considering the proposed rise in budget allocation for the public sector R&D in the country, Shimadzu Corporation, a leading global supplier of high quality instruments in quality control and research and development laboratories is keen on expanding its operations in India. Speaking to BioSpectrum, Wataru Tajima, deputy managing director, Shimadzu Analytical (India) Ltd, said, "We are now in the midst of expanding our Delhi office. We wish to build the Delhi office as an information hub to disseminate information i.e. about government funding that will help the organization in future." He further said, "The government's Budget for science and technology in 2005-06 was about $6.8 billion. And the projected Budget for 2010- 2011 would be about $ 48 billion. This will support the growth of the government sector, upgrading of education facilities and basic sciences. We do not want to miss this huge opportunity in the life sciences space, a booming sector in India."   Sartorius takes stake in Stedim Biosystems Sartorius AG, a global provider of laboratory and process equipment, has signed a binding agreement with the biopharmaceutical supplier, Stedim Biosystems SA, a company listed on the Paris stock exchange. Under the terms of the agreement, Sartorius acquires a substantial stake in Stedim and combined its biotechnology division with Stedim's business. Sartorius will pay â‚¬43 per share. Upon completion of this transaction, Sartorius will become Stedim's majority owner controlling the combined company. Through the combination of the Sartorius and Stedim biotech businesses, Sartorius is substantially strengthening its position as a technology provider to the fast growing biopharmaceutical market. Stedim's board supports this deal. The overall transaction, which is subject to approval by Stedim's shareholders and to regulatory clearance, is expected to be completed in summer 2007. The combined company will be named "Sartorius Stedim Biotech S.A." French-based Stedim is the pioneer for disposable bag systems for biopharmaceutical applications. Besides being a market leader in this segment, Stedim also has a product segment consisting of door systems for aseptic transfer technology and a unique proprietary freeze-thaw technology. Both of these technologies offer significant growth potential in the biopharmaceutical industry.   Waters' Synapt System wins Pittcon Editors Gold Award For the second time in three years, Waters Corporation has won the 2007 Pittcon Editors Gold Award for the best new product at the Pittsburgh Conference on Analytical Chemistry and Applied Spectroscopy (Pittcon). In 2004, the Waters ACQUITY UPLC System took home the gold and this year it was the Waters Synapt High Definition MS (HDMS) system that won the top prize at the 58th annual conference held in Chicago. The instrument made its debut in front of more than 20,000 analytical scientists and corporate executives attending Pittcon, the largest annual exposition on lab science. Used in small molecule research, protein characterization, metabolite identification and bio-pharmaceutical applications, the Synapt HDMS system is the first mass spectrometer of its kind to combine high efficiency, ion mobility based, measurements and separations with high performance quadrupole, time-of-flight mass spectrometry, a press release noted. "Synapt is designed to create new possibilities for scientists and researchers who want to take their research to the next level," said Dr Rohit Khanna, vice president, worldwide marketing, Waters Corporation.   BD, FIND expand collaboration to improve diagnosis of TB globally BD (Becton, Dickinson and Company), and FIND (Foundation for Innovative New Diagnostics) have expanded collaboration towards improving the diagnosis of tuberculosis (TB). Building on their two-year relationship to improve access to diagnostics in the developing world, BD and FIND formed this new collaboration in response to the emergence in many countries of extensively drug-resistant tuberculosis (XDR-TB). In September 2006, the World Health Organization issued an alert about the threat of XDR-TB and called for the strengthening of TB control worldwide. Rapid, accurate diagnosis of TB will reduce the time spent on inappropriate and ineffective patient treatment, which can lead to further drug resistance. Through cash and product donations, BD will support FIND's TB program to help strengthen laboratory services in developing countries. BD's commitment includes a cash donation of $100,000 and an in-kind product, training and service donation of approximately $200,000 market value.   Dr Phadke's Lab opts for Millipore's Elix water system Dr Phadke's Lab, a subsidiary of the Nicholas Piramal India Ltd (NPIL), which specializes in infertility, immunological, histopathology, genetic and microbiology tests and works closely with IVF centers all over the country, has employed Millipore's Elix water systems in conjunction with their Randox analyzers. The Randox system used by Dr Phadke and his colleagues allows for on-board sample dilution and includes an on-board cuvette washing system. Pure water is key for both of those applications to avoid introducing impurities that may result in false readings. In a clinical setting such as this, a false reading could lead directly to a false diagnosis that would negatively impact a patient's health. Because Wellspring's mission stresses the need for quality patient care, Dr Phadke's lab requires the consistently high quality pure water that can be provided by an Elix system. The water produced by Elix systems meets the highest standards and ensures consistent quality. Millipore's Elix water systems are fed directly with potable tap water and combine complementary purification technologies to produce water that meets or exceeds Type II water quality (corresponding to analytical-grade water) as defined by CAP, NCCLS/CLSI and ISO 3696/BS 3997. While water passing through the Elix module is purified, ion exchange resins are continuously regenerated via an electrical current applied within the module itself.   Pall expands line of instant aseptic connection devices Pall Corporation has expanded its line of Kleenpak Aseptic Connectors with two new sizes, 1/4- and 3/8-inch. The new sizes enable vaccine manufacturers to apply the safety and efficiency benefits of instant aseptic connections throughout more of their disposable operations to help speed time to market and comply with good manufacturing practices. Pall has revolutionized the aseptic connection process by shortening the time needed for connection from 15 minutes to seconds when it introduced its 1/2-inch Kleenpak Connector. The addition of the two new Kleenpak Connector sizes increases flexibility to implement aseptic connections in more applications to improve disposable processing efficiency. This is especially important to complex vaccine production, which often requires a greater number of connection steps, a press release says. Dr Helene Pora, marketing director, Pall Life Sciences, said, "Advances in aseptic connection are making disposable processing a more viable and profitable option for vaccine manufacturers. Pall has championed single-use technologies and will continue to expand its product offering so that more manufacturers can reap the benefits of disposable processing in even more applications." Rockwell, E+H alliance provides total process automation solutions Rockwell Automation and Endress+Hauser demonstrated the progress in their strategic alliance designed to deliver process-manufacturing solutions and develop next-generation process control technologies, at the 11th annual ARC Forum in Orlando recently. Formed in December 2004, the alliance aims to provide comprehensive solutions for plant engineering, operations and management to customers with a mix of process and discrete automation tasks, using Endress+Hauser's measurement devices and the Rockwell Automation integrated control and information architecture. The collaboration has focused on three key strategic initiatives: technology innovation, integrated asset management and coordinated engineering services. The two have been promoting field device tool/device type manager (FDT/DTM) technology that provides a single interface to devices residing on multiple field and control networks. They also support a range of standard bus technologies and have several board level positions, including the HART Communication Foundation, Fieldbus Foundation, FDT Group and ODVA. ]]> <![CDATA["The level of compliance is increasing"]]> https://biospectrumindia.com/news/95/5378/the-level-of-compliance-is-increasing.html https://biospectrumindia.com/news/95/5378/the-level-of-compliance-is-increasing.html Tue, 10 Apr 2007 12:48:00 +0530 New Page 1 "The level of compliance is increasing" -Dr Ludwig Huber, Compliance Fellow, Agilent Technologies, LSCA Dr Ludwig Huber, a Compliance Fellow at Agilent Technologies, has published more than 70 papers on validation and compliance and 21 CFR Part 11 and has been visiting India since the 1990s to participate in seminars on validation and compliance and to meet customers. Besides authoring books on the topic, Dr Huber has been a review member of PDA's task forces on "21 CFR Part 11" and "Validation of Laboratory Data Acquisition Systems", and of the GAMP special interest group on Laboratory Equipment. Currently, Dr Huber is on the scientific advisory board of the European Compliance Academy and a member of IVT's task force on network infrastructure qualification. Dr Huber spoke to BioSpectrum on issues related to validation and compliance during his visit to India. Excerpts of the interview: What were the missing links during the early 1990s related to compliance? There was very little emphasis on compliance then. It's knowledge space. They didn't know how to do it. And they couldn't afford to hire consultants from the US and Europe. Then there was very little expertise here in India on compliance. Things have changed now. There are a lot of books available in India from local authors and also from abroad. Journals and articles too are available on compliance and validation. There is now a high level education on these issues. What are your observations on validation and compliance in the early 1990s and now? The level of compliance and expectations is much more increasing. Earlier there was a lot of demand about information, but it is strange to know that not much implementation has taken place. The level of compliance now is on higher side if we look at Indian multinationals like Ranbaxy, Wockhardt, Cipla and Sun Pharma and subsidiaries of global companies like Johnson & Johnson, Sanofi Aventis. Now I don't find in anyway a significant difference between European countries and India. And it can't be because of as long as the companies look at exports, they have to comply with the regulations of the countries to which they are going to export. What was the driving force for the companies to look for compliance? The driving force was to be the ability to export to the US, Australia and European countries. The companies have recognized that those who are not satisfying the compliant issue of high standards will not be successful. They realized that they cannot sell APIs, intermediaries, finished products in the regulated markets and also cannot do research activities. Compliance and marketing go hand in hand. Even regulatory issue is a driving factor for companies to have compliance systems in place. How many Indian companies do you think are in compliance with validation and compliance systems? It's very difficult to answer this. I can't give the exact number. However, I feel at least 200 companies have complied with. And there will be many more. All I can say is that every company exporting to the US and Europe have no other choice. They are doing it actively. Do you feel Indian companies still have gaps in compliance? I think the gap is more so in electronic recording. This is the most recent revelation. The Indian customers are keen to have more information on it during my visit to India. How is the outlook for validation and compliance in India? Not only in terms of compliance and validation, the overall outlook is excellent. If you look at the market in India, initially the industry started manufacturing APIs, generic drugs. Now the market is penetrating into the research and development space and also in the area of contract research, clinical research and manufacturing. The whole market is expanding from manufacturing to early chain of value development. In terms of compliance and validation, there is big difference between the international and local companies, i.e. companies focusing on the local market and companies that are exporting to the US, Europe, Australia and Japan. I don't expect much from the companies targeting the Indian market as the compliance level with these companies is quite low and they don't have the necessary instrumentation to keep up this requirement. However, there is an initiative from the Indian government called Schedule M, which is a mandate that everyone selling in India or exporting has to comply with this regulation. Narayan Kulkarni   ]]> <![CDATA[Indigenous rapid filarial diagnostic kit launched in India]]> https://biospectrumindia.com/news/95/8157/indigenous-rapid-filarial-diagnostic-kit-launched-in-india.html https://biospectrumindia.com/news/95/8157/indigenous-rapid-filarial-diagnostic-kit-launched-in-india.html Tue, 10 Apr 2007 12:39:00 +0530 New Page 1 Indigenous rapid filarial diagnostic kit launched in India The diagnostic kit has passed through the stability testing as per European Pharmacopoeia and has also undergone both national and global surveillance studies Filariasis conjures up images of elephantiasis in the minds of the patients and the tedious process of midnight blood sampling in the case of doctors. Now both of them will become history with the launch of a rapid, antibody-based diagnostic kit "Signal-MF" aimed at the early detection of filariasis. Developed by Prof. P Kaliraj, Centre of Biotechnology, Anna University and his team in collaboration with Gujarat-based Span Diagnostics, this kit can be used to test blood samples anytime of the day and can detect the presence of infection in three minutes flat. In earlier detection methods, for microscopic observation, the blood samples had to be taken at midnight when the microfilaria parasite becomes active, which is not only inconvenient but also laborious and time consuming, thus not practically feasible under field conditions. Another alternative were the imported test kits, but they can detect only Wuchereria bancrofti, one of the filarial parasites causing the disease, besides being expensive. "The imported kits available in the market today are ELISA based and detect the antigenic protein. This detection methodology is not only expensive in terms of infrastructure required, but it also requires expertise and considerable time (about 4-5 hours). Hence this is not suitable for mass surveillance in countries like India. Moreover, these kits are not able to detect the infection caused by Brugia malayi, another filarial parasite which is incidentally endemic in parts of India," said Prof P Kaliraj, lead scientist of the study. Signal-MF is probably the world's first rapid antibody detection kit for simultaneous detection of Wuchereria bancrofti and Brugia malayi. Elaborating about the efficacy of the kit, Prof Kaliraj said, "The US-based Centre for Disease Control has carried out multicentric efficacy tests across five countries in different climatic conditions and the results revealed 90 percent sensitivity and 100 percent specificity." "This test kit will enable the early detection of the infection even in the case of children (below 10 years of age) which was generally missed out by the other kit in the market currently," he added. Launching the product on the occasion of the Foundation Day celebrations of the Department of Biotechnology in New Delhi, the Union minister for science and technology and earth sciences, Kapil Sibal said that such products would increase life expectancy and help achieve health for all. The technology transfer from Anna University, Chennai to Surat-based Span Diagnostics was facilitated by the Department of Biotechnology (DBT) for commercialization. The kit uses the anti-filarial antibody detection method, which is considered to be the most sensitive and accurate way of diagnosis of filariasis. The detection process provides evidence of the ongoing exposure to filarial infection long before the development of microfilaria, where detectable level of antigen is low due to slow growing nature of the disease. Even the WHO policy for global surveillance, monitoring and elimination of the disease recommends the antibody kit for the field application to monitor the exposure to disease in children and travelers. The diagnostic kit has passed through the stability testing as per European Pharmacopoeia and has also undergone both national and global surveillance studies, therefore recommended for use in India and other countries. Signal-MF has been developed as a part of the Filarial Genome Project of the World Health Organization, in which the Centre for Biotechnology, Anna University was involved in the process of sequencing the Brugia malayi genome. As the post genomic approach, Kaliraj's team had identified more than 20 targets of diagnostic and prophylactic importance from the cDNA libraries of Brugia malayi and Wuchereria bancrofti, the filaria causing parasitic worms. When asked about the challenges encountered during the development of the kit, Prof Kaliraj reminisced, "Filariasis being one of the neglected diseases, there are very few funding agencies which came forward to support the commercialization of the lead developed. We faced this problem after we had completed the sequencing efforts and had identified the candidate molecules. It was then that Span Diagnostics come forward and P Desai, chairman, Span Diagnostics, being a research oriented person, supported us. My earlier research experience in the industry also held me in good stead and the technology business incubator at the Anna University facilitated in taking the lead molecule forward." Upbeat about the recent commercial launch of the kit, he added, "A positive fallout of the our experience has been that realizing the challenges involved in the "bench to market route". The DBT has sanctioned a Rs 4.2-crore grant to develop a "Productization Platform" at the Anna University. Once developed, its facilities can be availed by any scientist in the country to take their leads forward." Sharing his views about the pricing of the product, he said, "Currently the price of the kit has been pegged at Rs 40 which can further come down once the demand for the kit picks up." "Beyond India, the kit has a market in South East Asia and some African countries where the disease is endemic. The initiatives and the required efforts to take the kit beyond India shall be taken by Span Diagnostics in the near future," he said. Dr Kaliraj's laboratory has also successfully developed a multiple antigen vaccine against the disease. Their filarial vaccine initiative had started about 10 years back and recently the research team has found 80 percent positive results in animal models with their vaccine. The Phase I clinical trials of the vaccine are likely to start soon after procuring the required approvals from the regulatory authorities. This project is being supported by the DBT and the Indian Council of Medical Research (ICMR). Prof Kaliraj is hopeful that if all goes well, in about two years time the vaccine will be in the market. Currently, human lymphatic filariasis affects more than 1.2 billion of the global population and is endemic in tropical regions of Asia, Africa, Central and South America. Significantly over one third of the endemic population is in India. The most common symptom of lymphatic filariasis is elephantiasis that involves thickening of the skin and underlying tissues. Elephantiasis is caused when the parasites lodge in the lymphatic system and it affects mainly lower extremities of the body. Rolly Dureha Molecular scale nanoscissor developed Researchers in Japan have developed a pair of molecular-scale scissors that open and close in response to light. The tiny scissors are the first example of a molecular machine capable of mechanically manipulating molecules by using light, the scientists say. The scissors measure just three nanometers in length, small enough to deliver drugs into cells or manipulate genes and other biological molecules, said principal investigator Takuzo Aida,, professor of chemistry and biotechnology at the University of Tokyo. "Chemists and biochemists may also use the scissors to precisely control the activity of proteins," Aida says. He presented details of the new technique today at the 233rd national meeting of the American Chemical society, the world's largest scientific society. Scientists have long been looking for ways to develop molecular-scale tools that operate in response to specific stimuli, such as sound or light. Biologists, in particular, are enthusiastic about development of such techniques because it would provide them with a simple way to manipulate genes and other molecules. "It is known, for example, that near-infrared light can reach deep parts of the body," said Kazushi Kinbara, associate professor of chemistry and biotechnology at the University of Tokyo and co-investigator of the study. "Thus, by using a multi-photon excitation technique, the scissors can be manipulated in the body for medicinal applications such as gene delivery." The scissors-like molecular machine uses a photo-responsive chemical group that extends or folds when light of different wavelengths falls upon it. Just like "real" scissors, the molecular scissors consist of a pivot, blades and handles. The pivot part of the scissors is a double-decker structure made of chiral ferrocene, with a spherical iron (II) atom sandwiched between two carbon plates. The three-piece unit creates a shaft that allows the scissors to rotate and swivel. Driving the motion are two handles strapped with photo-responsive molecules called azobenzene, which not only has the ability to absorb light, but comes in two isomeric forms: a long-form and short-form. Upon exposure to UV light, the long-form of azobenzene is converted into the short-form. Exposure to visible light transforms the short-form into the long-form. When UV and visible light are used interchangeably, the length of the azobenzene decreases and increases, which drives the handles in an open-close motion. The movement activates the pivot, followed by an opening-closing motion of the blades. Attached to the scissors' blades are organometallic units called "zinc porphyrin." When the zinc atom in the zinc porphyrin binds with a nitrogen-containing molecule, such as DNA, the zinc and nitrogen act like magnets, securing a firm grip on the molecule. "As the blades open and close, the guest molecules remain attached to the zinc porphyrin, and as a result, they are twisted back and forth," Kinbara said. In a recent study, the scientists demonstrated how the light-driven scissors could be used to grasp and twist molecules. The group is now working to develop a larger scissors system that can be manipulated remotely. Practical applications still remain five to 10 years away, the scientists said.   Small molecule to act as cancer therapeutic A small molecule derived from the spacer domain of the tumor-suppressor gene Rb2/p130 has demonstrated the ability to inhibit tumor growth in vivo and could be developed into an anti-cancer therapeutic, according to researchers at Temple University's Sbarro Institute for Cancer Research and Molecular Medicine. The researchers reported their findings, "A small molecule based on the pRb2/p130 spacer domain leads to inhibition of cdk2 activity, cell cycle arrest and tumor growth reduction in vivo," in the March 22 issue of the journal Oncogene. Rb2/p130 was discovered in the early 1990s by Antonio Giordano, director of the Sbarro Institute and the Center for Biotechnology in Temple's College of Science and Technology, who headed the study. The researchers discovered that within Rb2/p130's spacer domain-a sequence of 212 amino acids located in the pocket or middle section of the gene-was a small portion that resembled an amino-acidic sequence contained in the protein p21, which acts as a cdk (cyclin dependent kinase) inhibitor. Cdks play a critical role in cell cycle regulation. "What we tested was the ability of the Rb2/p130 spacer region to inhibit the kinase activity of cdk2, which is the same kinase p21 inhibits," said Giordano, one of the study's lead authors. "And to our surprise, it happened." The researchers then set about trying to reduce the spacer domain's 212 amino acids down to the smallest sequence that would still produce the same functionality as p21, explained Giordano. "We thought we could narrow down the spacer region that contains the protein-like motif to a small portion that could be delivered as a small molecule or peptide," Giordano said. They discovered a 39 amino-acid-long sequence, which they named Spa310. The molecule that was synthetically produced in the laboratory was introduced into mice that had been injected with tumor cells. "Tumor growth was inhibited and the tumors began to reduce in size until they disappeared," Giordano said. Giordano said because of the intrinsic nature of the compound, it can be easily reproduced as a biological drug in large quantities and does not require potentially dangerous means of delivery like viruses, as do most gene therapies; therefore Spa310 has a good chance to succeed as an anti-cancer therapy. For these reasons, he believes it may be easier to get approval for clinical trials. "Fifteen years after discovering Rb2/p130, our research and hard work has led us to the discovery of this small molecule, which is a step forward in cancer research and a big step toward a cancer treatment," he said.   ]]> <![CDATA['India favored for global studies']]> https://biospectrumindia.com/news/95/2458/india-favored-for-global-studies.html https://biospectrumindia.com/news/95/2458/india-favored-for-global-studies.html Tue, 10 Apr 2007 12:34:00 +0530 New Page 1 'India favored for global studies' -Dr Dan Weng, President ICON Clinical Research A Provider of outsourced development services to the pharmaceutical, biotechnology and medical devices industry, ICON Clinical Plc., specializes in the strategic development, management and analysis of programs that support clinical development - from compound selection to phase I-IV clinical studies. The global CRO operates across 30 countries and has a wide presence in Asia Pacific. In an interview with BioSpectrum, Dr Dan Weng, President ICON Clinical Research elaborates on the company's plan to increase its presence in the Asia Pacific countries. Give us an overview on ICON Clinical and its activities in the Asia Pacific region? We are primarily a global CRO, providing services to speed up clinical development, to pharma, biotech and medical device companies. We specialize in the strategic development, management and analysis of programs that support clinical development - from compound selection to phase I-IV clinical studies. The core team at ICON comes from a very strong clinical research background. In Asia Pacific, we have an extensive presence across countries and are growing. In fact, in terms of our current positioning with regard to our competitors, we are one of the largest global CRO in the Asia Pacific region. We cover all countries including Korea, China, Taiwan, Hong Kong, Thailand, Philippines, Singapore, Malaysia, Indonesia, Australia, New Zealand, India, China and Japan as well. Cost of the clinical trials in all of the Asian countries is lower than the US and Western Europe. In India, in the next two years, we are looking at doubling our size from the current 150 people. Companies are willing to shift the trials to Asia Pacific. Industry and sponsor requirements will determine our growth rate in Asia Pacific. What are the challenges that ICON faces in keeping up with the market requirement? Given that our business in growing, recruiting talented people is a major challenge. We need people with experience in global studies. In India, we want to double the size and we will be doing it by recruiting both the experienced people as well as fresh graduates, whom we will train. Hiring is a challenge in all geographies including Singapore and Korea as well. There are people with local and regional experience but not that many with global studies experience. Currently, we have 200 people on board for clinical research in Asia Pacific, excluding Japan and data management services. At ICON we are looking more at organic growth though we are not closed to acquisitions as such. Our India operation is growing faster than China. Regulatory approvals in China take at least nine to 10 months. Even though both the countries make for competitive locations, for global studies, companies prefer India rather than China on account of regulatory issues, ease of language and so on. Huge patient pool in India and China is an advantage. In Singapore or Hong Kong since the population size is small, even though the process is faster, we need to extend the trials, which adds to the cost. Any improvements that you would suggest India should look at, in the regulatory process or policy? Pharma companies across the globe are convinced that India is a great market. The support structures in India are very good. The government in India is very active on this front and is continuously making improvements. If it keeps up the same pace that is very good. However, to pick one area that impacts us - the country can work more on documentation simplification. The audit trail clarity is not there. It can be streamlined further. Nandita Singh   ]]> <![CDATA['DiabeCell will go to market in 2012']]> https://biospectrumindia.com/news/95/2127/diabecell-will-go-to-market-in-2012.html https://biospectrumindia.com/news/95/2127/diabecell-will-go-to-market-in-2012.html Tue, 10 Apr 2007 12:30:00 +0530 New Page 1 'DiabeCell will go to market in 2012' -Dr Paul Tan, CEO of Living Cell Technologies ASX-listed Living Cell Technologies Ltd develops live cell therapy products to treat life threatening human diseases. The vertically integrated company focuses on developing treatments where healthy living cells are injected into patients to replace or repair damaged tissue, without requiring the use of toxic drugs to prevent rejection. The company's product portfolio focuses on treatments for people with insulin-dependent diabetes and neurological disorders. The company owns a specialized biocertified pig herd for a safe, reliable source of cells for treatment. In an interview with BioSpectrum, Dr Paul Tan, the newly appointed CEO of Living Cell Technologies (LCT) outlined the company's expertise and future plans. What kind of presence do you have in the Asia Pacific countries? LCT's corporate head office and scientific panel are based in Melbourne, Australia. The company has also entered into collaborations with the Howard Florey Institute and the Bionic Ear Institute, both located in Melbourne. Its research and technology unit is in Auckland, New Zealand and hosts the world's most advanced porcine herd for therapeutic transplantation. Focused on research and the manufacture of product for pre-clinical and clinical studies, LCT has one of the southern hemisphere's only GMP clean room production facilities for encapsulated cell products. The in-house virology department has set the standard for porcine cell characterization around the world. The experienced and dedicated team, some with over 15 years of experience, supports the specific pathogen-free breeding facilities, clean rooms and research laboratories that interface seamlessly with the worldwide operations of LCT. The company has also conducted some pre-clinical research in Singapore. What is on LCT's horizon for the next five years? The focus of the company's operations continues to be advancing its lead products along the clinical trial pathway. The completion of the pre-clinical testing for the DiabeCell means that LCT is ideally placed to achieve its goal of two DiabeCell clinical trials â€“ one in Russia, the other in New Zealand. These phase I trials will be followed by a phase II clinical trial in the US under the guidance of the FDA. The product will be ready for commercialization within five years, with an expected market entry date of 2012 and perhaps earlier in jurisdictions where a market for animal cell therapeutics exist. LCT is looking at opportunities to market its pig tissue products in other fields and this may become a potentially lucrative revenue stream in the future. We are planning to build additional disease-free pig facilities that will help us grow and extract cells and tissues for clinical trials and eventually the manufacture of other medical products. Could you elaborate on your products and their applications? LCT's Biocapsules is a proprietary encapsulation technology that provides a significant delivery platform for its cell therapy products and enables licensing opportunities for a range of cell types. DiabeCell is a porcine pancreatic cell product for the treatment of insulin-dependent diabetes. LCT's Nt-Cell treatment implants choroid plexus cells into the brainand Fac8Cell product uses pathogen-free human liver associated cells (hepatocytes) to produce factor 8 required for blood clotting. Apart from the present applications, what are the new applications the company is researching on? LCT has a collaborative agreement with the Bionic Ear Institute to improve the hearing outcomes for cochlear implant patients through rehabilitation of the auditory nerve. LCT has the option to acquire an exclusive licence to commercialize the results. LCT also has an agreement with the Howard Florey Institute to investigate the effects of the company's proprietary NtCell capsules in nervous system diseases including Huntington's disease. Hasthana Rajappa   ]]> <![CDATA['We're on to small oncomolecules']]> https://biospectrumindia.com/news/95/1133/were-on-to-small-oncomolecules.html https://biospectrumindia.com/news/95/1133/were-on-to-small-oncomolecules.html Tue, 10 Apr 2007 11:22:00 +0530 New Page 1 'We're on to small oncomolecules' -Jan-Anders Karlsson, CEO of S*Bio S*Bio is Singapore's first fully integrated drug discovery company. Last year, it became the first homegrown company to develop a cancer compound. In January 2007, it opened a subsidiary in California to globalize its clinical development programs. The company counts Genome Institute of Singapore, Institute of Cell and Molecular Biology and Karolinska Institutet among its key research partners. BioSpectrum met up with Jan-Anders Karlsson, CEO of S*Bio for a one-on-one interview. Some excerpts: Could you tell us about the history of S*Bio? S*Bio is a JV between Singapore's Economic Development Board and Chiron Corporation. As Novartis bought over Chiron last year, they have become our second shareholders. We started as a drug discoveryand target validation genomics company. Over a period of five years, we beefed up our research capabilities and established ourselves as a strong research-focused company. From 2005, we expanded our focus from pure play drug discovery to development zeroing in on small molecule oncology. Our ambition is to become a fully-integrated biotech company in Asia. Currently, we are working on targeted therapies, oncology and developing new drugs. What are the focus areas of research for S*Bio? Our key focus areas are kinases and HDAC (Histone Deacetylases), epigenetic control of cell functions or proliferations. Our expertise is in understanding the biology of different kinase pathways and in understanding the importance of epigenomic regulation of HDAC enzymes. We developed our first preclinical development candidate, a HDAC inhibitor, SB939 in 2005. SB939 is Singapore's first homegrown clinical candidate to be developed as a novel targeted cancer therapy. It belongs to a novel series of targeted small molecule based anti-cancer agents that inhibit HDAC, enzymes that are important regulators of pro-apoptotic factors and proteins involved in cell cycle progression and differentiation. We have filed for an IND-equivalent in Singapore and are awaiting approval to start clinical trials. We are hoping to initiate the multiple phase I trials to begin in Singapore and North America later this year. Do you have any regional presence? Currently, we work out of Singapore. We do not have any regional offices in Asia. However, we have working relationships with chemistry outsourcing companies in China and India. Tell us about your new subsidiary in the US? We started the US operations to internationalize our clinical development capabilities. We wanted to be in close proximity with regulatory bodies such as FDA. Through our new office in California, we would like to expand our clinical development capabilities and competencies. This will also give us a platform to further develop our operations and presence in the US market. Currently, our US team is working on two compounds-JAK 2 for cancer and myloproliferative disorders and CDK/FLT 3, another type of kinase for blood tumors. Who are your collaboration partners? In Singapore, we work with Genome Institute of Singapore (GIS) for biomarker discovery and diagnostics and Institute of Cell and Molecular Biology (IMCB) to discover and develop multiple compounds for cancer treatment. Outside of Singapore, we have signed a research collaboration with Karolinska Institutet, a prominent Swedish medical university, for its histone deacetylase (HDAC) program. This agreement has provided an exciting opportunity to evaluate our novel and proprietary HDAC inhibitors in the treatment of colorectal cancers and to investigate the underlying mechanisms of the development of gastrointestinal polyps and tumors. What are your plans for the company? Over the next few years, we would like to be a public company, as that would give us resources to grow pipeline and become a significant player in oncology. Krishna Vilasini Bharadwaj   ]]> <![CDATA[India gears up to dominate with a huge presence at BIO 2007]]> https://biospectrumindia.com/news/95/2260/india-gears-up-to-dominate-with-a-huge-presence-at-bio-2007.html https://biospectrumindia.com/news/95/2260/india-gears-up-to-dominate-with-a-huge-presence-at-bio-2007.html Tue, 10 Apr 2007 11:07:00 +0530 New Page 1 India gears up to dominate with a huge presence at BIO 2007 The stage is set for the biggest global biotechnology show of the year, 2007 BIO International Convention of the Biotechnology Industry Association, USA (BIO), which will be held from May 6-9, 2007 in Boston, Massachusetts and India is participating in a big way this year. The Indian participation at 2007 BIO International Convention (BIO 2007) will be consolidated, and on a bigger and grander scale. Both the public and the private biotech sector organizations are confident of a good show at the event. This year the Confederation of Indian Industry (CII) is coordinating the India Pavilion at BIO 2007 in partnership with the department of biotechnology (DBT) and the Association of Biotechnology Led Enterprises (ABLE), which is a sectoral partner. The Indian participation has the full backing and support of the government. This is reflected by the optimistic thoughts of Kapil Sibal, the union minister for science and technology, about the biotech sector. "India will be at the center stage of the biotech industry in the world. India's biotech industry posted revenues of $1.5 billion in 2005 and is expected to top $2 billion this year. I am confident that the Indian biotech industry can reach $40 billion in revenues by 2015." "India's participation at BIO 2007 should be consolidated and on a bigger scale. We need to connect with the delegations of other countries more proactively and with quality. So we are using our influence in the different knowledge circles to come up with our best effort. We are also linking with the international programs of the science ministry. The idea is to connect the efforts of the Council of Scientific and Industrial Research (CSIR), the department of science and technology (DST) and the DBT with that of the industry organizations like the CII, ABLE, and FICCI so that there is more cohesion on an international platform," said Dr MK Bhan, secretary, DBT. Arun Prakash, CEO, Genetix Biotech Asia, New Delhi, said, "India's participation is much larger in 2007 as compared to 2006. India is the best possible biotech destination and a strong base for R&D, production or bioinformatics. India offers a bright pool of intellectual resources, attractive government incentive and modern infrastructure for the science industry." The DBT has also given a definite thrust to the participation of the Small and Medium size companies (SMEs) and entrepreneurs at BIO by partnering with CII so that the participation cost is subsidized for this sector. "There is a concerted effort to promote and encourage more medium sized companies and SMEs to participate at BIO. We are working with them to be there in a sizeable number," said Dr Bhan. Dr Rama Mukherjee, president, R&D, Dabur Research Foundation, Ghaziabad, stated, "The DBT has given a huge support to the participating companies, which is very encouraging." Another notable feature of the India Pavilion this year is that it is spread. The CII has secured about 4,400 sft prime location for the pavilion which is nearly four times the space as compared to the previous year. This will put the India pavilion at par with that of the many other participating countries. Supporting this view, Dr LMS Palni, senior scientific advisor, biotechnology, and project director, Uttranchal, said, "This year the DBT is supporting the Indian participation in a big way. A whole lot of space has been taken for the India pavilion and focused presentations will be made by different trade companies under one roof." A number of states like Uttrakhand, Himachal Pradesh, Maharashtra, and Karnataka are participating in the event. JP Negi, principal secretary (biotechnology), department of biotechnology, government of Himachal Pradesh and a member of the CII delegation, said, "At present, the Indian biotech sector is not mature enough and the vast exposure at BIO 2007 will have a multiplier effect in the proper direction in a big way. Biotechnology is an emerging area in an emerging market and we are gradually graduating but still not mature enough to capitalize on the strengths of India's diversity." Dr Palni elaborated about his earlier experience at BIO, "I had earlier attended the BIO 2005 which was held in Philadelphia and during that year there was a lot of talk and thrust on clinical trials. Two years down the line, we see that India is making big strides in this area and has become a favorable destination for certain clinical trials. Another topic which was discussed in great depth at BIO 2005 was the Bayh Dole Act and now India is in the process of enacting it for the country," he said. "I see these two key developments in the country as 'learnings' that we have taken forward from our exposure to an earlier BIO event." The private sector is equally optimistic about the Indian presence at BIO. Dr Rama Mukherjee, who has been a regular participant at the event, said, "There has also been a shift in the perspective of the participating Indian companies. Earlier the companies went to BIO to simply be a part of the biggest international annual biotech show, whereas now there is a concerted effort towards building business, networking, etc." Speaking about the benefits of attending the global meet, she observed, "India should gain immensely from this event. With the relaxation in the government rules and regulations (towards the life sciences industry) and the encouragement of the Indian government, all the companies should benefit a great deal. The BIO convention is the largest gathering of biotechnology leaders in the world, attracting more than 18,000 participants, featuring over 190 sessions, almost 1000 speakers, 17,6000 sft area, 60 pavilions and over 1700 exhibitors. New Page 1 "We will project a unified image of Indian biotech industry" -Dr MK Bhan, secretary, DBT What are your expectations from BIO Boston and how do you think India could benefit from the event? The Indian biotech industry holds a strong position in the Asia-Pacific region and constitutes around 2 percent of the global biotechnology market. The world has woken up to the fact that India is a country that cannot be ignored while plotting the landscape of the biotechnology industry of the future. BIO being the largest gathering of the global biotech fraternity, it is a platform to learn the latest know-how in the global industry and also to showcase the strength of the Indian biotech industry. It also provides unique networking and partnership opportunities for us to forge R&D collaborations and business development with other countries. What will be India's strategy at the event? In BIO 2007, India's objective is to showcase the strength of the Indian biotech industry by providing a platform to the Indian companies to showcase their products and technologies. It will also provide opportunities for forging new partnerships and networking with the global biotech community. With this view, several steps have been initiated: Biotech mission to the US (May 3-6, 2007): Mission members include government officials and industry leaders. A number of meetings have been scheduled with leading research institutions and industry in and around Boston. Exhibition: In BIO 2007, the India Pavilion is spread on massive area of 4400 sft at a very prime location. This would be the largest ever pavilion of India at the BIO. The Pavilion has participation from both the government and industry. International seminars: Two international seminars on "Indian Agri Biotechnology: The Growth Potential" and "India: Leveraging opportunities in Biotechnology" have been organized. Both the seminars have eminent speakers from the Indian government and industry. Networking opportunities: A seminar on "Indo-US Business opportunities: Biotechnology" is scheduled on May 4, 2007. The Indian biotech industry is growing at the rate of 37 percent and constitutes 2 percent of the global industry. The US is the largest market and world's leading biotechnology companies are located in Boston. There are immense opportunities that could be explored between the US and India for further development of biotechnology. In what way do you think BIO 2007 will be different from the previous BIO events? As mentioned earlier, the India Pavilion at BIO 2007 is located at a prime location and spread in area of 4,400 sft. This is the biggest pavilion India ever had in BIO. The India pavilion has participation from not only the industry but also the state governments. This will project a unified image of the Indian biotech industry. To provide the networking and partnership opportunities to Indian companies, we are organizing the mission and various international seminars.   US, India biotech leaders to hold summit at Boston A galaxy of leaders from the US biotech industry and venture capital segment will interact with the Indian biotech delegation at BIO Boston. The USA-India Chamber of Commerce has put together an exciting evening to bring face-to-face the industry leaders to take the Destination India story in biotech forward. Among the leading participants at the May 7 evening function at Boston's Omni Park Hotel  are Dr Helmut M SchÃ¼hsler, managing partner at TVM Capital, John Littlechild, managing director at Healthcare Ventures, George Bickerstaff, managing director at CRT Capital Group, Ed Mascioli, executive partner at MPM Capital, Stephen Knight, managing partner, Fidelity Biosciences, David U'Prichard, Partner at Care Capital. Prominent biotech company participants are Dr Alan Smith, chief scientific officer at Genzyme, Dr Peter Muller, chief scientific officer at Vertex Pharmaceuticals, Dr Francis Cuss, senior vice president, Pharmaceutical Research Institute- Bristol-Myers Squibb, Abbie Celniker, head of the program office at the Novartis Institutes for BioMedical Research. Union minister for S&T, Kapil Sibal, DBT chief MK Bhan and Biocon's Kiran Mazumdar-Shaw will participate as speakers. The US assistant secretary of commerce, Isreal Hernandez will be the most prominent US government delegate at the interactive session. India's trade and commerce minister, Kamal Nath said, â€œ The US-India Biotech Summit can further help in creating Centers of Excellence (CoEs) in biotechnology in the country. We seek to increasingly co-operate with the US in this area and exploit the synergy that exists in this field. The confidence of foreign investors in India is reflected in the highest ever inflow of Foreign Direct Investment (FDI) in the last two years. We are seeking investment into India because we believe investment to be a key factor in our economic transformation. USA-India Chamber of Commerce has played a significant contribution in the development of business ties between India and the US.â€? Why is Indian biotech hot? Reasoned James C Mullen, chairman, Biotechnology Industry Organization (BIO) and CEO and Biogen Idec: â€œIn India, the biotechnology industry has made important strides. The Indian biotech industry today comprises over 280 companies. India enjoys several benefits as a center for biotechnology including a large, well-educated base of professionals, ranging from biologists and geneticists to medical practitioners and statisticians. The country also includes diverse disease populations for clinical trials and drug development. Finally, India's unique and diverse plant, animal and microbial bio-diversity provides exciting research opportunities. This summit is part of an ongoing dialogue, said Karun Rishi, president of the USA-India Chamber of Commerce. The summit will have two panel discussions. One on discovery, development, IP & regulatory issues and the second on investment opportunities, crossborder investment and M&A trends in the life sciences industry.   ABLE to push for investments in biotech ABLE member companies participating at BIO Boston 2007 are: Advinus Therapeutics; Aurigene; Avestha Gengraine Technologies; Bhat Biotech; Biocon India; BioSpectrum; Biovel Life Sciences; Commexios Life Sciences; Leader Prospects India; Nadathur Holdings; Ocimum Biosolutions; Polyclone; Strand Life Sciences; Tata Consultancy Services; And Yes Bank. The Association of Biotechnology Led Enterprises (ABLE), the apex Indian biotech association, has partnered with CII for BIO Boston 2007 and played a major role in planning and promoting the India Pavilion and Mission for the event. ABLE, with about 20 of its members, would be participating in the India mission. ABLE has also partnered with USAIC (USA-India Chambers of Commerce) to promote the India-US biotech summit, which is a high powered networking session intended to accelerate the trade and investments between the US and India. ABLE members attending this summit will leverage this platform to interact with delegates from many leading US biotech and investment companies. The summit will have two panel discussions. One on discovery, development, IP and regulatory issues and the second on investment opportunities, cross border investment and M&A trends in the life sciences industry. Kapil Sibal, the union minister of science and technology, and Dr MK Bhan, secretary, DBT, are expected to be keynote speakers. Senior partners of prominent life sciences companies, venture funds, and academic institutes will be participating in the summit. "Many of our member companies are ready to license their technologies and partner with the big pharma companies. Indian companies are also actively looking for acquisitions, mergers and tie-ups. We therefore plan to promote both inward and outward investments at this forum," said Nandita Chandavarkar, director, operations, ABLE. BIO being one of the largest platforms to network with biotech and allied companies across all geographies, ABLE plans to promote two of its forthcoming flagship biotech events-BIOINVEST 2007, which will be held on November 1-2, 2007 in Mumbai, and BIOPARTNERING 2008, which will be held in Hyderabad in January 2008. ABLE will also enter into a strategic tie-up with BIO to work closely in the Asia region. Indian Mission Program May 3, 2007 Visit and Interaction with Whitehead Institute Meeting with Chilean Delegation to BIO 2007 Visit Millennium Pharmaceuticals May 4, 2007 Visit to Biogen Idec Visit to Genzyme Visit to Novartis Institute CII Conference on Indo-US Business Opportunities in Biotechnology Visit to the Massachusetts Institute of Technology (MIT) Visit and meeting at Boston University Networking with International and Massachusetts Bio and Research Organizations by MOITI** May 7, 2007 Inauguration of India Pavilion India Conference â€“ "Indian Agri Biotechnology: The Growth Potential" Brief media on Indian biotechnology India Conference â€“ "India: Leveraging Opportunities in Biotechnology" Canadian Networking reception ** May 8, 2007 Thought leader Plenary Session: "Market transitions: Forging ahead in Asia" ** Tentative program   The exhibitors at India Pavilion are: ABLE; Advinus Therapeutics; Avestha Gengraine Technologies; Biocon; CII; CSIR; Dabur Research Foundation; DBT, Government of India; Department of Biotechnology, Govt. of Andhra Pradesh; Department of Biotechnology, Govt. of Gujarat; Department of Biotechnology, Govt. of Himachal Pradesh; Department of Biotechnology, Govt. of Rajasthan*; Department of Biotechnology, Govt. of Tamil Nadu*; Department of Biotechnology, Govt. of Uttarakhand; Genetix Biotech Asia; Jubilant Biosys; Karnataka Biotechnology & Information Technology Services (KBITS); Maharashtra Industrial Development Corporation (MIDC); Reliance Clinical Research Services; Sandor Proteomics; Tata Consultancy Services; And Veeda CR * to be confirmed     ]]> <![CDATA["It is easy for Indians to integrate in our region"]]> https://biospectrumindia.com/news/95/2278/it-is-easy-for-indians-to-integrate-in-our-region.html https://biospectrumindia.com/news/95/2278/it-is-easy-for-indians-to-integrate-in-our-region.html Mon, 09 Apr 2007 18:38:00 +0530 New Page 1 "It is easy for Indians to integrate in our region" -Hans Marti, head, economic promotion, Department of Economic Affairs, Canton of Zug You are a strong believer in the promise that India holds. Can you share a few specific details as to why you think so? India is a fast growing market and has an excellent and well-educated workforce. Due to the fact that India is a democracy and entrepreneurs are thinking in a very business-oriented manner, there will be a huge expansion potential for innovative companies. Due to the fact that labor costs in India are much lower than in Europe, manufacturing companies have a great chance to export their products to Europe. We assume that in the future, the sales and distribution activities will be organized by subsidiaries of Indian companies in Switzerland. Can you briefly share three main reasons as to why the Canton of Zug would be an attractive investment destination for Indian companies? Zug offers a lot of well-known advantages. That's why many international companies have chosen Zug as a hub for their activities in Europe. Most companies consider the low taxes for companies and individuals as the most important factor. The availability of well-trained and international experienced managers, a central and good reachable location and an extremely high quality of life are also very important reasons for companies to move here. While economic considerations seem strong enough, one of the inhibitors for Indian companies to set up operations in Switzerland comes from a social issue and that is a lack of sufficiently large Indian community in Switzerland (8000 Indians is a small number). What are the specific steps that you would recommend in that direction? This is a fact which cannot be changed immediately. More and more companies hire Indian experts and there is also a growing population of expatriates from other countries. But we will never get an Indian community as it exists in New York or London. Because it is so easy for Indians to integrate in our region, it seems that an economic driven company can easily overcome this obstacle. What were the main benefits from the two conferences held in Bangalore and Hyderabad recently? We could establish some very interesting contacts and have in total three concrete prospects. In addition we got some other interesting leads from a seminar, which the Canton of Zug has held in Mumbai in cooperation with the CII. We are in further discussions and I assume that a few firms will establish here in Zug soon. It was important to show Indian entrepreneurs specific business cases, so that the Indian companies could learn about their possibilities of doing business in Switzerland and specifically in Zug. Do you get the impression that the Indian life sciences sector would be interested in investment in Switzerland? Or is the potential more in some of the other sectors and if so, which one? There are already some very interesting companies in Zug. As an example we can mention Wockhardt, which has just recently set up their European headquarter in Canton. We are in contact with other very promising companies. The life sciences sector is growing very rapidly in the areas such as sales organizations, intellectual property companies and finance structures etc. We see also a huge potential in the medical device industry and in trading activities. The Canton of Zug belongs to the top three or four locations worldwide for commodity trading (metals, oil and coffee). Over the next decade, what is the trend that you are able to visualize in terms of association between Swiss and Indian companies? Many Swiss companies already have subsidiaries in India. This number will grow over the next decade. But we assume also that more and more Indian companies, which are successful now in India, will expand internationally to Europe. And for those companies, Switzerland is an ideal hub for starting business in Europe. So the number of Indian companies investing in Switzerland will definitely increase over the next decade. E Abraham Mathew   ]]> <![CDATA[Swiss woo Asian Biotechs]]> https://biospectrumindia.com/news/95/2567/swiss-woo-asian-biotechs.html https://biospectrumindia.com/news/95/2567/swiss-woo-asian-biotechs.html Mon, 09 Apr 2007 17:18:00 +0530 New Page 1 Swiss woo Asian Biotechs Switzerland is making a strong pitch to life science companies in the Asian region to relocate to the country and grow their businesses the Swiss way Switzerland generally conjures images of snow-laden Alps and gourmet Swiss chocolates but that is just one side of the story. The country also has an excellent research and development infrastructure, particularly in the area of biotechnology. It is among the top 10 countries worldwide having the largest number of biotech companies. Switzerland's mature and stable biotechnology base comprises about 229 biotech companies. Nearly 60 percent of these are the "Core Biotechs" --innovation-oriented and research-based Small and Medium Enterprises (SMEs). While the other 40 percent function as "enablers", providing support by way of instruments, services and consulting etc. The biotech industry employs about 14,400 people. Importantly, R&D in Switzerland is multi-and trans-cultural, with more than 50 percent of the PhD students and post doctorates being of non-Swiss origin. According to the Swiss Biotech Report 2006, out of a total of 523 biotech products under development in Europe by publicly listed companies, 109 are from Swiss companies. Switzerland stands second in the European ranking in innovative capabilities. What makes Switzerland a good location for biotechs? "In a technology friendly environment, Switzerland has a qualified and highly motivated workforce. Stable political and social conditions, a flexible job market as well as an effective infrastructure and attractive tax framework make the country a rewarding choice for any innovative company," said Switzerland's Minister for Economic Affairs, Joseph Deiss. The country has seen a spurt in entrepreneurship during the last 10 years as the number of companies has doubled from 111 in 1995 to 229 in 2005. The annual turnover of the biotech industry in 2005 was approximately 6 billion CHF. And during the same year about CHF 295 million of venture capital found its way into the Swiss biotech firms, which makes Switzerland the third largest in Europe in terms of venture capital influx into the country. Switzerland has a major thrust on "Red Biotech", the pharmaceutical research and development. Nearly half of the core biotech companies have a strong focus on therapeutics, while the rest concentrate on drug discovery technologies and services, genomics, proteomics and enabling technologies, drug delivery, tissue engineering and diagnostics. In terms of pharmaceutical product pipelines of public companies, Switzerland ranks second after the UK in Europe. Optimal co-operation and co-ordination between the important stakeholders like the Universities, Federal Institutes of Technology, the biotech industry and the various government organizations has been the key to the exciting and rapid development of Swiss biotech sector during the past decade. The country has a strong R&D funding and support system. The main state funded biotech R&D and structural support comes from the Swiss National Science Foundation and the Swiss Agency for Innovation Promotion. The Swiss National Science Foundation fully funds many basic research programs in the public sector, while the Swiss Innovation Promotion Agency (KTI/CTI) provides support to the start- up companies, and also funds applied research in the universities, federal institutes of technology and the universities of applied sciences. Money matters The Switzerland Stock Exchange (SWX) is a leading European exchange for life science companies to raise capital. It has two sector-specific index family that include SXI Life Sciences and SXI BIO+MEDTECH which increases both visibility and liquidity for domestic and foreign biotech companies. There are also over 40 venture capital firms and private equity funds, various science parks and incubators to support innovative biotech companies. For example, Speedel, a biotech company based in Basel raised nearly $200 million in private risk capital through several rounds of financing. It listed on SWX in September 2005 with a valuation of $700 million. Among the leading companies listed on SWX are Actelion, Novartis, Roche and Serono, which SWX officials say create a global environment for entrepreneurs. Promising companies In recent years, many Swiss biotech companies have come up to do cutting edge research. Molecular Partners, founded by Prof. Andreas Pluckthun at the University of Zurich is a well-known start up working on antibodies. His research team works on a new class of molecules similar to antibodies and are based on repeat proteins. With the designed repeat protein (DRP) technology, it is now possible to produce designed ankyrin repeat proteins (DARPins) to combat any given cell structure. "They behave just like antibodies but are much more stable and easier to produce than conventional antibodies," said Christian Zahnd, a company official. "An additional factor is that the DRP technology enables us to open doors that have long been closed to us in the antibody field where patents are so hard to come by." DARPins can be used as reagents in the research market, in diagnostics or therapeutic applications. Apoxis, a spinout from the University of Lausanne, is another notable company. Founded by two university professors, Lars E French and Jurg Tschopp, in 2002, along with serial entrepreneur, Jean-Pierre Rosat, Apoxis is working on developing therapeutic products using the principle of apoptosis or programmed cell death. The company has already discovered two new molecules in the tumor necrosis factor (TNF) family which have been out-licensed to the US company, Biogen. One of these molecules has shown promising results in hard-to-treat cancers. With excellent environment and infrastructure and the access to the vast European market, Switzerland is making a strong pitch to life science companies in the Asian region to relocate to the country and grow their businesses the Swiss way. Swiss delegations have been visiting India and other Asian countries to woo Asian entrepreneurs in a big way and one can expect more such visits from the land of Alps. E Abraham Mathew recently in Switzerland & Rolly Dureha   ]]> <![CDATA[Biodiesel industry still in infancy]]> https://biospectrumindia.com/news/95/4810/biodiesel-industry-still-in-infancy.html https://biospectrumindia.com/news/95/4810/biodiesel-industry-still-in-infancy.html Mon, 09 Apr 2007 17:08:00 +0530 New Page 1 Biodiesel industry still in infancy Biofuels are gaining acceptance worldwide as good substitutes for oil in the transportation sector. In India, the demand for diesel is five times higher than the demand for petrol, but the biodiesel industry is still in its infancy. BioDiesel production is rapidly growing in Europe and the US. Current estimates show production of 2.2 MT/year in Europe, with Germany (1.1 MT per year), France (0.5MT per year) and Italy (0.4MT per year) being the leading producers. The Biodiesel production is about 2,45,000 tons per year in the US. The European Union mandated that its members derive at least two percent of their fuel consumption from biofuels by 2005 and 5.75 percent by 2010. Recently, the European Council endorsed the policy proposal of the European Commission that there should be at least a 10 percent share of biofuels in all road transport fuel by 2020 in all EU member states. The Indian government formulated an ambitious National Biodiesel Mission to meet 20 percent of the country's diesel requirements by 2011-2012. India's current biodiesel technology of choice is the transesterification of vegetable oil. Since the demand for edible vegetable oil exceeds supply, the government has decided to use non-edible oil from Jatropha curcas seeds as biodiesel feedstock. ICRISAT promotes pro-poor biofuels initiative The International Crops Research Institute for the Semi-Arid Tropics (ICRISAT) is linking the poor and marginal farmers of the drylands of the developing countries with the global biofuels revolution without compromising on food security. "We call this our pro-poor biofuels initiative for the dryland farmers where food security is not compromised," said Dr William Dar, director general, ICRISAT. "With the fuel prices increasing globally, there is a demand for ethanol from sweet sorghum and biodiesel from pongamia and jatropha. We believe that this provides a wonderful opportunity for dryland farmers to get more money from their farms and wastelands." Ethanol from sweet sorghum ICRISAT scientists have bred sorghum varieties and hybrids in partnership with national agricultural research partners that yield higher amount of sugar-rich juice. Conventionally ethanol is produced from sugarcane. Sweet sorghum scores over sugarcane as it is a crop of the drylands, and thus its cultivation can benefit the poor and marginal farmers of the drylands. Even though the ethanol yield per unit weight of feedstock is lower for sweet sorghum, the much lower production cost for this crop more than compensates for this loss, and sweet sorghum has a competitive cost advantage. It costs Rs 12.79 to produce one liter of ethanol from sweet sorghum, while it costs Rs 14.55 to produce ethanol from sugarcane. "Sweet sorghum's benefit is three-fold," said Dr Belum VS Reddy, ICRISAT's principal sorghum breeder. "It provides the dryland farmer with grain, fodder for the cattle and an additional source of income through bioethanol. Sweet sorghum requires only one seventh of the water that is used up by sugarcane". Sweet sorghum has advantage over other biofuel crops that it yields grain as well as ethanol. Rather than replacing land grown to food, the cultivation can stimulate increased yield of grain and stalk, and also fodder from bagasse. Normal grain sorghum is already grown on 11.7 million hectares in dryland Asia and 23.4 million hectares in Africa. "From an acre of sweet sorghum, we can get a minimum of 15 tons of cane," says Rami Reddy, a farmer who has planted sweet sorghum. "Rusni buys this from us at Rs 500 per ton. So a farmer makes a good income from his sweet sorghum field, which is in addition to the 200 to 400 kg of grain that he harvests." ICRISAT has linked the lab, industry, farmer and the market through the public-private partnership initiative of its Agri-Business Incubator. The research to develop improved varieties was linked with the technology package that entrepreneur AR Palaniswamy, managing director, Rusni Distilleries, has developed. "By partnering with ICRISAT through its Agri-Business Incubator, our distillery at Mohammed Shahpur village, Medak district of Andhra Pradesh, has become the world's first plant to commercially produce ethanol from sweet sorghum," said Palaniswamy. "We have linked with farmers, to whom we are supplying seeds of sweet sorghum varieties, and buying back their produce." According to calculations made by Rusni Distilleries, a 40 kiloliter-per-day ethanol from sweet sorghum plant in India can benefit 5,000 farmers and provide 40,000 man-days of labor per year. By planting sweet sorghum instead of grain sorghum, dryland farmers can get an additional income of Rs 1,763 per hectare per crop. This is the benefit they get in addition to the existing benefit from the grain. In addition to the Rusni project in India, ICRISAT has signed agreements with five private companies in the Philippines to form a sweet sorghum for ethanol consortium. Further, ICRISAT and Rusni are in the initial stages of exploring such consortia in Uganda, Nigeria, Mozambique and South Africa. Biofuel from pongamia and jatropha ICRISAT's initiative to produce biofuels is not limited to bioethanol alone. ICRISAT is promoting the cultivation of pongamia and jatropha crops, from which biodiesel can be extracted. "We have partnered with the Andhra Pradesh Government to permit poor villagers, especially women's groups, to grow pongamia and jatropha on wastelands and collect the fruits," said Dr SP Wani, regional theme leader on watershed development, ICRISAT. In partnership with GTZ, the German development cooperation organization, ICRSAT is working with Southern Online Biotechnologies, which has already established a 40 kiloliter-per-day biodiesel plant in Nalgonda district of Andhra Pradesh. Biodiesel yields even greater reductions in air pollution than ethanol, since fossil fuel diesel is polluting considering the popularly used diesel technologies in the developing countries. Compared to fossil fuel-derived diesel, biodiesel reduces unburnt hydrocarbons by 30 percent, carbon monoxide by 20 percent and particulate matter by 25 percent. The planting of biodiesel crops also helps sequester atmospheric carbon into tree biomass. The World Bank bought 147 tons of carbon credit from Powerguda village to neutralize the emissions of air travel by participants of an international conference held in Washington DC, USA, in October 2003. The National Biodiesel Mission is being implemented in two stages: n A demonstration project carried out over the period 2003-2007 aimed at cultivating 4 lakh hectares of jatropha to yield about 3.75 tons of oilseed per hectare annually. The project will also demonstrate the viability of other aspects like seed collection and oil extraction. The expected annual biodiesel production from the project is 1.2 tons per hectare per year for a total of 4 lakh tons per annum. In addition, the government will build a transesterification plant with a biodiesel production capacity of 80,000 tons per year as part of the demonstration project. n A commercialization period during 2007-2012 will continue Jatropha cultivation and install more transesterification plants which will position India to meet 20 percent of its diesel needs through biodiesel. Currently, India has taken the initial steps towards commercial production of biodiesel. The work accomplished so far includes developing high-yielding varieties of jatropha, initiating jatropha nurseries, setting up pilot plants for biodiesel manufacture and testing biodiesel in public transport locomotives and buses. Phase 1 of the National BioDiesel Mission seeks to demonstrate the viability of all aspects of successful biodiesel manufacturing enterprise. The amount of land available for jatropha cultivation is estimated to 13.4 million hectares, which could potentially yield 15 MT per year of jatropha oil. Experts suggest that while new infrastructure for seed collection, oil extraction, transesterification, biodiesel storage blending with diesel and marketing are needed in the country, more importantly, large scale cultivation of jatropha must be established before biodiesel production can meet even a five percent blending requirement nationally. The main problem in getting the biodiesel program rolling has been the difficulty in initiating the large-scale cultivation of jatropha because farmers do not consider jatropha cultivation rewarding enough. The other main issue is the lack of seed collection and oil extraction infrastructure as with the available oil seeds, it is difficult to persuade entrepreneurs to instal transesterification plants. Commercial biodiesel production At present, Southern Online Biotechnologies is among the first companies that has commenced the commercial production of biodiesel in the private space with an investment of Rs 21 crore in the project. Its biodiesel manufacturing plant at Samsthan Narayanpur, Nalgonda district, Andhra Pradesh has a production capacity of 30 tons per day or 9,000 tons per year. Elaborating on the plant, N Satish Kumar, MD, Southern Online, said, "We have been producing biodiesel since the past four months at the capacity of 40,000 litre/day capacity. Our plant is multi-feed stock based and is the first domestic biodiesel unit in India and amongst the first in the Asian region as well." The project implementation was done by Chemical Construction International Ltd (CCIL), a New Delhi-based engineering and technology company, which has an exclusive technical collaboration with Lurgi Sciences, Germany, a leader in fatty acids, glycerol and biodiesel technologies. And in this way Lurgi's biodiesel technology has come to India via CCIL. Southern Online conducted trial runs on APSRTC (Andhra Pradesh State Road Transport Corporation) buses jointly in coordination with APSRTC and APPCB (Andhra Pradesh Pollution Control Board) from June 2005 to March 2006. After the trial runs as per the report of the APPCB, the product registered excellent reduction in pollution. With the successful completion of the trial runs, the company again ran a few more APSRTC city buses from June 2006 to September 2006 on biodiesel on various blends, i.e. B5, B10, and B20 (means biodiesel 5, 10 and 20 percent and regular conventional diesel 95, 90 and 80 percent respectively) in coordination with APSRTC to observe mileage of the vehicle with these blends. During the trials, the biodiesel registered higher mileage when compared with regular diesel and a 40 percent reduction in the pollution levels. Following its first venture, the company has decided to establish one more biodiesel unit as a 100 percent Export Oriented Unit (EOU) in Visakhapatnam for which it is planning to raise around Rs 175 crore through a rights issue and from the overseas market. Commenting on the recent Budget announcement of full exemption of excise duty, Satish Kumar said, "Biodiesel consists of 89.5 percent vegetable oil and 10.5 percent methanol, thus it comes under the vegetable oil segment by default. In Andhra Pradesh, vegetable oils are already exempt from the excise tax and just attract 4 percent VAT duty. In order to encourage the sector, the government should be give concessions like power subsidy, investment subsidy and custom duty exemption for raw material imports in the biodiesel sector." In addition the government should relook into the biodiesel purchase policy by evaluating the present price of the seeds/seed oil, processing expenses and other industry expenditure." The Ministry of Petroleum and Natural Gas notified a Bio-diesel purchase policy which provided for purchase of biodiesel by oil marketing companies at the rate of Rs 25 per litre (inclusive of taxes/duties/transportation cost) with effect from January 1, 2006 at about 20 purchase centers in 12 states. The industry experts in this segment are of the view that the seed (jatropha, pongamia) procurement price from the farmers is about Rs 6 and the cost of extracted oil (jatropha, pongamia) is itself about Rs 25-26 and when the cost of technology conversion to biodiesel is added to it, the price becomes Rs 33-34. So it is not feasible to sell biodiesel at the price of Rs 25 in the country. In comparison, the EOUs are selling biodiesel to international buyers at the rate of Rs 37.50. "The biodiesel industry needs active government support to flourish in the country. Even though we are currently producing biodiesel commercially, there are not many takers for it within the government sector. So, at present, we are selling it to domestic direct customers like the private transport fleet owners, truck and bus owners, who are happy with the performance of our biodiesel," said Satish Kumar. "We have also opened our retail shop on the national highway and our next expansion step will be setting of an EOU. At the same time, with the help of ICRISAT we are also encouraging farmers to plant jatropha on wastelands and have assured them a buyback price of Rs 6 for the seeds." Another company on the verge of commercial production of biodiesel is Naturol Bioenergy Ltd, which is again based in Andhra Pradesh. Their biodiesel plant is based in the port town of Kakinada, which is a 100 percent export oriented unit. The envisaged capacity of the plant is 100,000 tons per year. In 2006, Naturol Bioenergy inked a strategic technology partnership with De Smet Ballestra Group of Belgium for implementing its Rs 140 crore integrated biodiesel plant at Kakinada. Jaganath, CFO, Naturol Bioenergy, stated, "The commercial production from the plant will start by June this year and the plant is more than 80 percent ready. Right now we are in the advanced stage of tapping the European and US markets and signing contracts with some companies in the US and the Europe." Naturol's bio-diesel plant designed on multiple feedstock ranging from palm oil and jatropha to soya bean, will produce 300 tons per day of biodiesel and employ 200 workers. The project, claimed to be one of its kind in Asia, had a debt to equity ratio of 1.5:1. APIDC Venture Capital, which was the first to support the project from the concept stage, helped it raise further funds from other equity investors such as UTI Venture Funds and SIDBI Venture Capital. Under the project, about 1.20 lakh acre of dry wastelands can be taken up for cultivation based on vegetable oil seed plantations. In addition, Naturol is planning to set up additional biodiesel plants at Visakhapatnam in Andhra Pradesh and in various South Asian countries. It had already initiated discussions with potential partners in Thailand, Indonesia and Sri Lanka and for the next three years the company has planned production on imported feedstock from Malaysia. It expects to get jatropha from 1.5 lakh acres in Andhra Pradesh to supplement its stock. The company has also been talking to various tissue culture laboratories in India to enable multiplication of the right germplasm, which would be provided to the participating farmers to meet the escalating demand for jatropha seedlings. "The biggest challenge for the industry is the availability of raw material in the country, as India is a large importer of vegetable oil. In the absence of the availability of raw material within the country (the thrust on jatropha plantation has been on since the past few years and so the required volume of seeds will be available only after 2-3 years) the companies will have to import it from abroad initially," said Jaganath. Concurring with the demands of the other industry leaders for government support, he opined, "The industry is still awaiting the National Biodiesel policy from the government, which will hopefully support the sector." Welcoming the recent Budget announcements, he said that this is a nascent industry and requires all possible support. "Currently in India the appetite for usage of biodiesel is still not very visible. So the market is not large. This has to change and parallely the biodiesel industry has to also develop so as to cater to their needs," he added. TNT India starts biofuel efforts Environmental concern is a top global priority for TNT Express, one of the world's leading business-to-business express delivery company. And "Driving Clean" is a global initiative for TNT in addressing the environmental concern by using alternatives like biofuels. As part of this initiative, kick-started after a senior managers' meeting in January 2007 in the Netherlands, TNT India too has launched a pilot biofuel project in early March this year. Abhik Mitra, managing director, TNT India Pvt Ltd, informed, "The Driving Clean initiative is a global action plan to improve the environmental performance of our fleet. We have started the pilot on three trucks on the Pune-Nasik-Bangalore route. We will test the biofuel and ecodriving performance." TNT runs over 1,000 trucks every day and the success of this pilot project would decide its future course of action. Though it was too early for Mitra to comment on the transit time, cost economics, sourcing of fuels etc., TNT is hopeful that it can take the biofuels up to 20 percent levels in diesel in the future and expand this project to its entire fleet. Each of the biodiesel truck covers about 45,000 km per month and the project aims to reduce carbon emissions by up to 337 tons per year per vehicle. TNT is one of the first express organizations in India to contribute to the biofuels strategy and is optimistic about the future of clean driving. Other Trial Runs using 5% biodiesel blends Railways used biodiesel on some regularly scheduled train journeys Tractors tested by Mahindra &Mahindra Mercedes cars tested by Daimler Chrysler Public transport buses tested by Haryana Roadways, Bombay Electric Supply and Transport, among others In addition trials marketing of 5 percent diesel blends through some retail outlets have been conducted by the oil company Bharat petroleum Corporation Limited (BPCL) National Biodiesel Mission Key aspects of Phase I Demonstration Project (2003-2007) Plantation area coverage Nurseries development Seed collection and oil extraction centres Blending and marketing and Financial requirement Phase II (2007-2012) Aim: Produce sufficient vegetable oil-based biodiesel to achieve 20 percent blending Strategy: Accelerate the momentum achieved in the demonstration project Convert plantation into a mass movement all over the country Duration: Will begin in 2007 and completed during the XI plan (2007-2012) The success of the demonstration project is expected to galvanize all the stakeholders and participants to mobilize resources with the government as the facilitator. Rolly Dureha   ]]> <![CDATA[Indian CROs have an edge over Chinese]]> https://biospectrumindia.com/news/95/2713/indian-cros-have-an-edge-over-chinese.html https://biospectrumindia.com/news/95/2713/indian-cros-have-an-edge-over-chinese.html Mon, 09 Apr 2007 17:03:00 +0530 New Page 1 Indian CROs have an edge over Chinese Finance Minister P Chidambaram has proposed the exemption of service tax for clinical research organizations (CROs) in the recent Budget. And this move is expected to add strength to the existing advantages India offers to the sponsors. The Indian clinical research organizations (CROs) sector is growing at nearly 70 percent over the previous year's revenues of Rs 425 crore with exports dominating the sector. There are over 70 companies active in this space. Most of these are actively involved in doing bioavailability/bioequivalence (BA/BE) studies with a handful of them into clinical trials (Phase Iâ€“IV). Considering the potential of doing business in India, many leading CROs of the world who are looking at both India and China as potential markets of investments, are entering India. Given the two countries' low cost base and huge potential patient populations, both the countries are offering services in abundance. According to a report on "Looking Eastward" from the Boston Consulting Group, almost all the top multinational pharmaceutical companies have already offshored some clinical trial work to India and many have offshored to China as well. The surge has been extraordinary. Considering the advantages India has and its offerings to the sponsors, McKinsey has estimated that the size of the clinical research market in India will be close to $1.5 billion by 2010. At present the market is just $160 million. But will the ambitious $1.5 billion number become a reality? The government has been making all efforts to make this dream come true. Some of the issues concerning the CROs have been addressed in the Union Budget 2007 like doing away with the service taxes. At the cost of losses Service tax was imposed on clinical trials for testing of drugs and formulations last year. Accordingly, fees charged for clinical trial services in India had attracted service tax at the rate of 12.24 percent (including education cess) under the category "technical testing and analysis services" in the hands of the Indian CROs. Further, service tax would also to be liable on pass through costs of the Indian CROs (such as investigator fees, transportation etc). It may thus be seen that service tax would be an additional high impact cost to the nascent Indian clinical trials industry and a huge deterrent, especially at a stage where India is facing increased cost competitiveness from countries in Latin America, Eastern Europe and China. The main reason till date for the growth of the clinical trials industry has been India's superior cost arbitrage, which has negated factors such as infrastructure challenges and the fact that India is not 'near shore' vis-Ã -vis the global players. For instance for the fees charged, if the US has a price base of 100, India and China run neck to neck with a price base of around 66, with the Latin American countries following closely at 75 and Eastern Europe at 80. Accordingly, China and Latin American countries are extremely close to India in terms of "price for clinical trials". In such a scenario, Indian CROs would completely lose out on their price/cost advantage and international competitiveness if service tax at 12.24 percent is added to their fees charged as well as the pass through costs. It is therefore suggested that the CRO industry be exempted from the levy of service tax on all its activities including clinical trials to encourage it. Since it is a nascent industry as also to enable to retain its internationally competitiveness. Post the recent Budget announcements, Indian CROs are on a high, as now the testing and analysis service provided by the CROs in relation to testing and analysis of newly developed drugs on human participants to ascertain the safety and efficacy of such drugs is fully exempted from levy of service tax with effect from March 1, 2007. This will result in an estimated revenue loss of Rs 50 crore for a full year to the government. Welcoming the initiative, Dr Kiran Marthak, director, Veeda Clinical Research, Ahmedabad, said, "The government has recommended waiver of service tax of 12.5 percent for the new drugs that will include new chemical entities, new formulation, new mode of admin and sustained release/extended release formulation etc. Thus it will not only help in conducting various phases of clinical trials but will also aid bioequivalence clinical trial study for newly developed formulation for better compliance." Dr Arun Bhatt, president, ClinInvent Research, New Delhi, said, "The removal of service tax on clinical research will allow us to give competitive pricing to our sponsors. This will also save valuable time and efforts of our project and finance team, which has been earlier lost in explaining to our foreign clients the concept of service tax and in complying with the requirements of filing returns." Sharing his thoughts, Prashant Tewari, managing director, USV Ltd, Mumbai, said, "Clinical research is being encouraged as part of the budget provisions and is also expected to gain momentum due to the impetus provided." Similar views were echoed by Vimal Kumar, whole time director, Shasun Chemicals & Drugs Ltd, Chennai. He said, "The move to exempt service tax on clinical trials and the cut in duty for pharma research equipment will be beneficial for the overall safety and efficacy trials in the industry." Dr Surinder Kher, CEO, Jubilant Clinsys, New Delhi, said, "Certainly this is a positive step. This notification will translate into the Indian companies offering a 12.36 percent saving to the sponsors of clinical studies. Any saving is definitely an advantage but decision-making on outsourcing, besides being based on the cost advantage is also based on a few other factors which are equally critical like the quality of work, the confidence of working in a particular geographic territory, knowledge of English language among others. So this step will give a positive impetus to the industry but at the same time, I do not see this decision having an immediate impact on the volume of studies coming to India, especially from the US or UK." Reacting to the Budget proposals, Dr Rajeev Soni, COO, Premas Biotech, New Delhi, said, "These will certainly provide the boost to Indian CRO industry and will lead to a huge expansion in not too distant future. The only question and/or concern is that is this benefit extended to contract research organizations as well." He added, "The budget proposals would give a leading edge to Indian CROs in terms of cost competitiveness, bagging more projects in the global market. And it might help to a certain extent for next five years or so as the costs of operating in India are going up. Ultimately, it will be quality combined with cost rather than cost alone that will attract global giants towards India. The move by the finance minister will certainly benefit the sector and more companies would start operations in this area thereby inducing competitiveness." "Exemption from service tax of companies involved in clinical trials or NCE development work, reflects the growing incentivization of basic R&D. The point to note is that there are few companies involved in clinical trials. The way forward to meet the objectives of boosting R&D would be to extend the benefits across the spectrum of clinical trials," said Utkarsh Palnitkar, leader, business advisory services, Ernst & Young Pvt Ltd, Hyderabad. Voicing his views, Dr Shivprakash, managing director, Synchron Research Services, Ahmedabad, said, "The finance minister has provided the much needed cost advantage to our international and domestic clients to make India a favorable destination for clinical trials. The finance minister must also look into the possibility of bringing the CRO industry on par with the IT industry in terms of tax structure, which will help CROs build international standard R&D facilities for clients." "CROs spend quite a sum on rent. This is high in case of CROs with BA/BE. Service tax on rent affects adversely. Removal of service tax benefits sponsors and improves cost position for India. Changes in ESOP make it expensive to reward and retain top quality professionals," said DA Prasanna, managing director, Manipal AcuNova, Bangalore. Nitin Deshmukh, private equity group, Kotak Mahindra Bank Ltd, said, "Service tax exemption for the companies engaged in drug testing and clinical trials of drugs is a positive outcome of this Budget. I am however very disappointed with ESOPs being brought under FBT. This will be very adverse for the development of biotech industry in India. ESOPs are an integral part of the growth process of any biotech company as well as the industry. Unlike IT, the biotech industry is highly capital intensive, high risk and not cash flow positive or enjoys low profitability for long initial years. While the IT industry is probably mature in the Indian context, the biotech industry is yet to take any critical mass by global standards. Therefore ESOPs under the ambit of FBT is very damaging for the biotech industry. This measure has probably being taken with focus on the more profitable IT industry without understanding the collateral damage to other fledgling sectors such as biotech. "As such India as well as China are considered the preferred economic countries for conduct of clinical trials. With the waiver of service tax, India will attract more clinical trial activities as it would now become cheaper by 12.5 percent and will also help Indian pharma R&D companies in exploring various phases of clinical trials within the country. On the whole, the waiver of service tax will bring more customers to contract research organizations, said Dr Kiran Marthak. The government cannot fulfil all needs of the industry at a time. But it can take up the issues one after the other. The government is keen support the sector so that it can compete in the global market. Narayan Kulkarni with inputs from Rolly Dureha & Namratha Jagtap   ]]> <![CDATA["We focus on producing high-value products"]]> https://biospectrumindia.com/news/95/1342/we-focus-on-producing-high-value-products.html https://biospectrumindia.com/news/95/1342/we-focus-on-producing-high-value-products.html Mon, 09 Apr 2007 16:51:00 +0530 New Page 1 "We focus on producing high-value products" Dholka is a small village about 50 km from Ahmedabad. This dusty village is a base for one of the new emerging biotech companies, Concord Biotech Ltd, that is producing amidase enzyme, statins and immunosuppressants. For the last six years, it is believed to be the largest producer of amidase enzyme by capturing 80 percent market share. It also claims to be the only company to produce all the immunosuppressants in the world. The man who made all this possible is Sudhir Vaid, a hardcore biotechnologist, who believes in the future of biotechnology. The story behind the acquisition of Concord Biotech by Sudhir Vaid from DSM, a Dutch multinational company, is quite interesting. Vaid learnt about DSM having 27 acres of land near Ahmedabad and also the fact that DSM was using only 1.5 acres of the land. Acting quickly, he funded the acquisition of DSM, which was lying idle and had a very clean balance sheet, through his savings. The entire property was purchased at over Rs 3 crore. The finance person and the maintenance man who were earlier part of the DSM team joined him. He drove down with two young chemists from Delhi to Dholka in a Maruti 800 to start the operations in 2000. In about three months, he started the production of amidase enzyme at the facility, for which he used equipment bought from DSM at one-tenth of the cost from their other facility where it used to produce pencilin G. He has transformed this chemical facility into a biotechnology facility by producing immobilized enzyme through recombinant strain and named it Concord Biotech Ltd. It is now the largest producer of this enzyme with production touching 11 tons. In 2004, the commercial production of Lovastatin was started. Alongside, the company started development of immunosuppressants. In May 2005, Concord Biotech became the youngest company to get the USFDA approval in India. Every year Concord has been adding on two new manufacturing blocks. At present it has seven dedicated blocks for enzymes, statins, and immunisuppressants covering a built-up area of 12-13 acres. Then it started producing Tacrolimus, Mycophenolate Mofetil, and Mycophenolate Sodium. Later on, it has added Pravastatin and Sirolimus. It is now going to start production of Vancomycin HCl. It has dedicated plants for all these different products and has been supplying all these products to the US and most of the other regulated markets. With the growth of the organization, there has been an increase in manpower too. In a period of five years, the number of employees has risen from three in 2000 to 320 in 2006. However, in December 2005, Hyderabad-based Matrix Labs, now Mylan (also a customer of Concord), acquired 55 percent equity in Concord. As per the agreement with Matrix, Sudhir Vaid is the managing director for a period of five years and he still has four more years to go. During this period, he plans to make Concord a leading global R&D-based biotechnology company and is confident of realizing his dream faster. In an exclusive interview to BioSpectrum, Sudhir Vaid spells out his company's plans for the future.   What was the driving force for Concord to move from amidase enzyme to statins and immunosuppressants? Initially we focused on the production of amidase enzyme and became the largest producer of enzymes. We now enjoy 80 percent of the market share. In 2003, we decided to diversify into statins and immunosuppressants. Since the beginning, my target was to look at a niche and focused markets for high-value low-volume products. Why did you sell your equity stake to Matrix Labs? When I got finances from UTI, our competitors went for IPO. And were growing very fast. In order to grow faster, I had to look at other alternatives. I got one private equity stakeholder and he is also our USFDA agent. Impressed with the facility, he invested about 8-10 percent in the company in 2004 end. Rakesh Junjhunwala, a Mumbai-based investor and stockbroker, showed interest in the company and invested about 15 percent. They valued the company at Rs 30 crore in 2004. However, I felt I should grow faster. And that is how Matrix Labs came into the picture. It valued Concord at around Rs 105 crore in 2005 when our sales were Rs 18 crore. I personally feel that the company might be currently valued at Rs 500 crore at present as our sales are about Rs 45 crore. At present I hold around 33 percent stake, Matrix holds 52 percent and Rakesh Junjhunwala and the rest (includes Glopac, a Canadian company and Concord employees) hold about 15 percent. Earlier Rakesh Junjhunwala and Glopac diluted their stakes when Matrix Labs, now Mylan, acquired stakes in Concord in December 2005. How are you coping with pricing pressures in the statins market? We are present mostly in the regulated market, produce high quality products and are very competitive. We are the people who have given the technologies to most of the companies like Teva, Lupin, Krebs, and Biocon. We know how to compete in the market. Our technologies are much superior. Our team has been continuously working on strain improvements. It's a continuous and ongoing process. For instance, in enzymes, China has been selling at $190â€“200 per kg while Concord Biotech has been selling in China at $120 per kg. We know how to give a tough fight to China. We are exporting to China and I feel we can do much better than China. Even in India, statins used to be sold at Rs 1 lakh per kg. When we entered the market, we sold it at Rs 20,000 a kg and people didn't digest this. At that time Fermenta was the only company. They waited for a year. But by that time, we had captured the entire market. When it brought down the price to Rs 20,000, we reduced it to Rs 10,000 per kg. Again it took six months for them to bring down the prices. They came down to Rs 6,000 and we reduced it to Rs 7,000 a kg. And now we have been selling at Rs 6,000 per kg. So we have brought down the price from Rs l lakh to Rs 6,000. This competition helped the bÃªtalactamine industry as well. It was almost a revolution. What are your current revenues? The revenues are expected to touch around Rs 45 crore for the year ending March 2007. We are now looking at a target of Rs 100 crore for the next year as we will be commissioning a Vancomycin plant from this March. Immunosuppressants and statins contribute a major chunk of our revenues. And of course now antibiotics will be there. About 40 percent of our revenues come from exports. The sales in the unregulated market are quite low. So we mostly cater to the space that is interested in the regulated market. How strong is your R&D activity? There are about 20 personnel working in our biotech R&D division and 10 in the chemical synthesis division. After fermentation, we need to do chemical synthesis. And there's a separate lab for that. The team at Concord is working hard in developing non-infringing processes for the existing and new products and till date Concord has filed eight process patents and many more are in the pipeline. We are now working on how to go about getting into the recombinant products or biosimilars segment. And our aim is to enter biosimilars. We are not looking at the EPO, insulin, GCSF and likewise biosimilars as that is already a crowded segment. We want to go into a better market. If you look at our products under development, we have Taicoplanin (anti bacterial), Caspofungin (anti fungal), Everolimus and Pimecrolimus (immunosuppressants), Eplerenone-corticosteriod (cardiac arrest) and Drosperinone-corticosteriod (contraceptive). We plan to enter the niche markets only. We have already identified some of the markets. We believe in producing high-value, low-volume products. To survive in this competitive market, one should be on the toes and need to commercialize new molecules faster than the competitors. How do you look at the domestic market for immunosuppressants and statins? It is good market for immunosuppressants. There are only two major players. However, there are many players in the statin space and this has really killed the market. The prices have come down drastically. So it is difficult to compete in the local market following the USFDA guidelines. People who are not following the USFDA guidelines can do what they want. The quantity will increase and the prices will further go down. A lot of the developments are going on in the technologies, like for example enzymatic conversations are going to come in. So the pressure will be on the higher side. Those having the fermentation facility and adapting to the technologies, are going to be the winners. As of now everyone is into chemical synthesis. When it comes to fermentation, you need to have the facility. So biotechnology is the future. However, there is confusion in the market. Some people feel that if you want to make Simvastatin, you need to have Lovastatin of DMF grade material, if you want to sell in the US. A few others feel you can go with non-DMF grade Lovastatin and sell in the US. But I feel one needs to have critical raw material required to have a DMF grade. But there is no clarity on this. Narayan Kulkarni   ]]> <![CDATA["The regulatory scene for phage products is becoming more favorable"]]> https://biospectrumindia.com/news/95/2582/the-regulatory-scene-for-phage-products-is-becoming-more-favorable.html https://biospectrumindia.com/news/95/2582/the-regulatory-scene-for-phage-products-is-becoming-more-favorable.html Mon, 09 Apr 2007 15:35:00 +0530 New Page 1 "The regulatory scene for phage products is becoming more favorable" -Dr J Ramachandran, president & CEO, GangaGen Biotechnologies, Bangalore Patents are an integral part of development of any biotech company. GangaGen Biotechnologies has always focused on developing strong intellectual property rights (IPR). "We now have three major broad patents issued in the US and one of them is also now issued in the European Union and we have about another nine patents pending," said Dr J Ramachandran, president & CEO, GangaGen Biotechnologies. GangaGen is actually now much closer to the market than it was two years ago. In the veterinary business domain, its products are directed at fighting E. Coli infection in pre-slaughter cattle (that causes hamburger disease in humans), dairy cattle and salmonella-prone poultry and will be in the form of feed additives. On the human safety side, its first product is for controlling Staphylococcus aureus bacteria, which causes hospital infections and is spreading into the community. GangaGen is now gearing up to be in Phase I clinical trials with this product early next year. The second human product GangaGen is working on is against another major pathogen called Pseudomonas aeruginosa. Pseudomonas causes infection in burns and wounds and this is a major issue in India. This problem exists even in the US. In the US and other western countries, Pseudomonas is also known to cause cystic fibrosis, a condition where there is congestion in the lungs. And GangaGen's phage product can also be helpful there. However, it is developing this mainly to address the burns and wounds market. "If the western pharma companies evince interest in this product to tackle cystic fibrosis, we would be more than willing to partner with them," added Dr Ramachandran. In an exclusive interview to BioSpectrum, Dr Ramachandran shares the company's plans and initiatives. Since GangaGen is purely an R&D company, how do you plan to market your products and peg revenues? ELANCO, the animal health division of pharma major Eli Lilly, entered into an agreement with GangaGen in August 2005. As per the agreement, ELANCO will market our phage product directed against E.Coli and we are expecting to submit for approval at the end of this year. Hopefully the product will be in the market early in 2008. The company has already brought in some revenues in terms of the technology access fee, milestone payments and the project now is fully funded by ELANCO. We have already done four field trials and we will do a major trial in spring this year, which we will be finishing in summer. Regulatory agencies like the US FDA and the agencies in Canada and Europe have become much more aware of the potential of phages and are getting proactive. Now this is a major change compared to what the scene was like two years ago. Phage is being viewed as an ally in the fight, especially against antibiotic resistant infection. So we foresee less regulatory hurdles for the phage products that we are developing. We are also now being approached by other big US and European companies as well as a few Indian companies for phage products in food safety and animal health. Also we have started talking to some pharma companies as well for human therapeutics and we are reasonably optimistic about the outcome. We will conclude at least one agreement by the end of this year or may be even two, which will add to the revenue stream and more importantly, add to the validation of our technology and the value of the company. Will GangaGen be going in for another round of funding? We have turned a corner for a variety of reasons. The funding was difficult in the initial stages but we have been very fortunate to have investors who are primarily individual investors mainly from the US and a few from India and they have had strong faith in our technology. In fact we completed a major round in November last year which was primarily initiated by one of the existing investors. The round started in September last and by the end of November, we closed with $4.5 million. This provided us enough resources coupled with the fact that we have been getting revenues from ELANCO already and we are in a reasonably comfortable situation. Additional revenues will come in with other agreements. We will probably need more funds next year to accelerate a few projects and go into clinical trials in human therapeutics. The existing investors are very supportive and if things go on track, I anticipate that they will step forward to lead the next round of funding. Are you looking at mergers and acquisitions (M&As)? We would like to add value to the company and make more progress. We would want to advance our products to a later stage before we look at M&As. But the nature of our business is such that there are many opportunities. We have our food safety and veterinary businesses progressing well. If there is a separate possibility for M&As, we would certainly consider it, provided the terms are very attractive and we will retain the human therapeutics for ourselves until a later stage. What are your expansion plans? We are expanding as we are taking up new projects. The primary expansion will be in Bangalore. There would some expansion in our Canada setup as well. As we conclude other agreements, we will dedicate people to these projects. In Bangalore we are now 30 of us and we will probably grow to 40-45 in the next 18-24 months. And in Canada, the number may grow to 15-20. This is the anticipated growth. What are your other plans? As I mentioned earlier, the regulatory scene for phage products is now becoming more favorable because phage is really nature's solution and phages have kept bacteria in check for nearly 3.5 billion years now. By taking this ancient cure and developing modern medicines, we can address a large number of heath-related issues in the developing world. Diarrhoeal diseases which cause infant mortality in the developing world and diseases like TB, cholera can be controlled very effectively with affordable phage products. It is my dream to make these products available in the developing world. Namratha Jagtap     ]]> <![CDATA[Human Resource Support]]> https://biospectrumindia.com/news/95/1313/human-resource-support.html https://biospectrumindia.com/news/95/1313/human-resource-support.html Mon, 09 Apr 2007 14:54:00 +0530 New Page 1 Human Resource Support The number of public and privately funded institutions offering biotechnology and related courses has been growing in the country and there are at least 300 quality institutions in the country. These will be a key driver to fuel the growth of the biotech sector in the country. India is one of the first few countries in the world to initiate an integrated program of human resource development in biotechnology comprising of post graduate teaching programs, short-term training courses for upgrading skills of mid-career scientists, faculty involved in undergraduate and post graduate teaching, training in leading overseas laboratories, in gap areas where expertise does not exist in the country. Currently, the department of biotechnology (DBT) which is the nodal agency for overseeing the development of this niche sector in India, is supporting post graduate biotech educational programs in about 74 universities across the country, which nurtures about 935 post graduate professionals annually in the biotech arena. In addition, there are an increasing number of private institutes venturing into biotech education with a variety of undergraduate and post-graduate programs. The DBT supported post-graduate courses were initiated way back in 1985 in six universities in close collaboration with the University Grants Commission, ICAR and the department of ocean development. The programs were conceived as collaborative, inter-departmental and inter-institutional programs. Later, these were expanded in the areas of general, medical, agricultural, marine, veterinary, industrial and pharmaceutical biotechnology. These programs served a catalytic role and many other institutes later initiated these programs.   Number of institutes running DBT supported PG Programs (area-wise) Course Specialization Number of Universities Annual intake of students General Biotechnology 41 530 Agricultural Biotechnology 9 110 Medical Biotechnology 1 10 Marine Biotechnology 2 30 Neurosciences 3 25 Industrial Biotechnology 1 10 M Tech Biotechnology 9 140 MVSc 2 15 Post MD/MS Certificate 2 9 PG Diploma 4 56 Total 74 935 DBT's HRD Support Ph.D. (JRF): 43 (Each year w.e.f 2004-05) Post Doctoral Fellows: 150 Overseas fellowship: 25 Bioinformatics Centers of Excellence: 05 Distributed Information Centers: 11 Sub-Distributed Information Centers: 49   The DBT has set up seven autonomous institutes in modern biology. These are: National Institute of Immunology (NII), New Delhi National Centre for Cell Science (NCCS), Pune Centre for DNA Fingerprinting and Diagnostics (CDFD), Hyderabad National Brain Research Centre (NBRC), New Delhi National Center for Plant Genome Research (NCPGR), New Delhi Institute of Bioresources and Sustainable Development (IBSD), Imphal Institute of Life Sciences (ILS), Bhubaneswar   The DBT supports 25 biotech facilities and centers of excellence. DBT Program Support for promotion of excellence Indian Institute of Science, Bangalore Bangalore University, Bangalore Rajiv Gandhi Centre for Biotechnology, Thiruvananthapuram     ]]> <![CDATA[Favorable Policies]]> https://biospectrumindia.com/news/95/8166/favorable-policies.html https://biospectrumindia.com/news/95/8166/favorable-policies.html Mon, 09 Apr 2007 14:53:00 +0530 New Page 1 Favorable Policies Government support has given a significant boost to the fledg-ling Indian biotech sector. In recent times, the Indian government has formulated a few new policies and made amendments to the existing ones, which support the biotech segment. Many of these policies, like the Foreign Trade Policy, SEZ Act, Seed Policy, Pharma Policy and stem cell research guidelines are essentially roadmaps for the respective sectors and aim at unshackling of controls, creating an atmosphere of trust and transparency, simplifying procedures, along with offering attractive incentives where possible. Put together, they create a vibrant atmosphere for the holistic growth of the life sciences/biotechnology sector. A snapshot of the important policies. Foreign Trade Policy The Indian Foreign Trade Policy is essentially a roadmap for the development of India's foreign trade. Identifying and nurturing different special focus areas to facilitate development of India as a global hub for manufacturing, trading and services is one of the key strategies highlighted in the Policy to increase the country's foreign trade. According to the Policy, Bio-Technology Parks (BTPs) will be granted all facilities of 100 percent Export Oriented Units (EOUs). The BTPs would be notified by the Director General of Foreign Trade (DGFT) on the recommendations of the Department of Biotechnology. In case of units in the BTP, necessary approval/permission under relevant provisions will be granted by the designated officer of the Department of Biotechnology. The Policy will extend the following benefits to the Bio-technology Parks (BTPs): EOUs shall be exempted from Service Tax in proportion to their exported goods and services EOUs shall be permitted to retain 100 percent export earnings in EEFC accounts Income tax benefits on plant and machinery shall be extended to DTA units which convert to EOUs. Import of capital goods shall be on self certification basis for EOUs Exemption from payment of income tax as per the provisions of section 10A and 10B of the Income Tax Act. 100 percent FDI investment permitted through Automatic Route similar to SEZ units.   SEZ Act The Special Economic Zone (SEZ) scheme is an extension of the existing Export Oriented Unit (EOU)/Software Technology Park (STP)/ Hardware Technology Park (HTP) schemes. With an idea to boost exports, rope in investments, development of infrastructure and generate employment, the government introduced the concept of SEZs in the year 2000. The SEZ Act came into force in India on February 10, 2006. Incentives and benefits Under the provisions of Sections 26 to 30 of the SEZ Act, 2005, every developer or an entrepreneur setting up a unit in an SEZ, qualifies for exemption from duties of customs, excise, income tax and all other levies of the state or the Centre in terms of sales tax or VAT and the supplies made by domestic vendors qualify for benefits extended to physical exports. The specific incentives offered to developers, co-developers and investors include: 100 percent FDI allowed for: townships with residential, educational and recreational facilities on a case-to-case basis, franchise for basic telephone service in SEZ Income Tax benefit under (80IA) to developers for any block of 10 years in 15 years Duty free import/domestic procurement of goods for development, operation and maintenance of SEZs Exemption from Service Tax/CST Income of infrastructure capital fund/Co. from investment in SEZ exempt from Income Tax Investment made by individuals etc in a SEZ co also eligible for exemption u/s 88 of IT Act Developer permitted to transfer infrastructure facility for operation and maintenance Generation, transmission and distribution of power in SEZs allowed Full freedom in allocation of space and built up area to approved SEZ units on commercial basis Authorized to provide and maintain service like water, electricity, security, restaurants and recreation centers on commercial lines   National guidelines for stem cell research and therapy The Indian Council of Medical Research (ICMR) jointly with the Department of Biotechnology has recently expanded the draft guidelines for stem cell research, incorporating the technical issues involved in embryo research. The guidelines categorize stem cell studies into three main groups: permissive, restrictive and prohibitive research along with suggesting a provision for a two-tier evaluation and monitoring mechanism-one at the institutional level for permissive research and the other at the national level for restrictive research. While reproductive cloning, in vitro culture or manipulation of human embryo beyond 14 days post fertilization, germ line gene therapy fall in the prohibitive category, in vitro studies on established human embryonic stem cells (hES) or adult somatic stem (hSS) cells to understand processes of development and differentiation is in the permissive category. The guidelines also stipulate the norms for establishing human embryonic stem cell lines clearly. While hES cell lines from spare embryos have been put in the permissive category provided the spare embryos are obtained in an ethically acceptable manner, the hES cell lines from embryos specifically made for this purpose has been kept in the restrictive category. These measures are in place to check the unnecessary creation of embryos just for the sake of establishment of a hES cell line. The guidelines will not only address the safety issue concerned with therapeutic treatment but will also ensure that the stem cell lines generated fulfil the basic Good Manufacturing Practices (GMP) requirements for clinical use. Hence, on one hand the guidelines will provide impetus to stem cell research in the right direction while on the other they have a provision for continuous updation of the three categories (permissive, restrictive and prohibitive) depending on the scientific progress made in the field. Although these guidelines are self regulatory now, an Act would soon be passed in this regard. The law, which is at a drafting stage, is aimed at curbing misuse and allaying fears among the public about using them as 'guinea pigs' through human trials.   Recombinant pharma guidelines The Mashelkar Committee report on recombinant pharma products streamlines the regulatory process for the approval of all recombinant DNA products. The recommendations of the report came into effect from April 1, 2006. According to the Task Force Report, LMOs (Living Modified Organisms) are defined as only those organisms modified by r-DNA techniques through human interventions where the end product is a living modified organism. The report has rationalized the regulatory procedure for five categories of LMOs: Indigenous product development, manufacture and marketing of pharmaceutical products derived from LMOs but the end product is not a LMO Indigenous product development, manufacture and marketing of pharmaceutical products where the end product is a LMO Import and marketing of LMOs as drugs/pharmaceuticals in finished formulations where the end product is a LMO Import and marketing of LMOs as drugs/pharmaceuticals in bulk for making finished formulation where the end product is a LMO Import and marketing of products derived from LMOs as drugs/pharmaceuticals in bulk and/or finished formulations where the end product is not a LMO The report also specifies the timelines for various approvals by the regulatory committees-RCGM approval for pre-clinical animal studies: 45 days; DCGI approval for human clinical trials protocol: 45 days; DCGI examination of clinical trial data and response: 90 days; and concurrent DCGI and GEAC decisions: 45 days. Another important highlight of the report is that it has recommended the constitution of a Standing Technical Advisory Committee on Biotechnology Regulation under the chairmanship of an eminent scientist to redress and look into various regulatory aspects and make issue-based recommendations on case-by-case basis prior to any deviation from the regulatory mechanism.   National Seed Policy The National Seed Policy acknowledges the role of biotechnology in agricultural development in the coming decades. The main objectives of the National Seed Policy are the creation of an appropriate climate for the seed industry to utilize available and prospective opportunities, safeguarding the interests of the Indian farmers and the conservation of the agro-biodiversity. In the context of application of modern technologies to agriculture, it aims at providing a conducive atmosphere for application of frontier sciences in varietal development and enhanced investments in R&D. The Policy has laid down the following rules/guidelines regarding the transgenic plant varieties: All genetically engineered crops/varieties will be tested for environment and bio-safety before their commercial release, as per the regulations and guidelines of the Environment Protection Act (EPA), 1986. The EPA, 1986, read with the rules, 1989 would adequately address the safety aspects of transgenic seeds/planting materials. A list will be generated from Indian experience of transgenic cultivars that could be rated as environmentally safe. Seeds of transgenic plant varieties for research purposes will be imported only through the National Bureau of Plant Genetic Resources (NBPGR) as per the EPA, 1986. Transgenic crops/varieties will be tested to determine their agronomic value for at least two seasons under the All India coordinated project trials of ICAR, in coordination with the tests for environment and biosafety clearance as per the EPA before any variety is commercially released in the market. After the transgenic plant variety is commercially released, its seed will be registered and marketed in the country as per the provisions of the Seeds Act. After commercial release of a transgenic plant variety, its performance in the field will be monitored for at least three-five years by the ministry of agriculture and the state departments of agriculture. Transgenic varieties can be protected under the Plant Varieties & Farmers' Rights Protection (PVP) Legislation in the same manner as non-transgenic varieties after their release for commercial cultivation. All seeds imported into the country will be required to be accompanied by a certificate from the competent Authority of the exporting country regarding their transgenic character or otherwise. If the seed or planting material is a product of transgenic manipulation, it will be allowed to be imported only with the approval of the Genetic Engineering Approval Committee (GEAC), set up under the EPA, 1986. Packages containing transgenic seeds/planting materials, if and when placed on sale, will carry a label indicating their transgenic nature. The specific characteristics including the agronomic/yield benefits, names of the transgenes and any relevant information shall also be indicated on the label. Emphasis will be placed on the development of infrastructure for the testing, identification and evaluation of transgenic planting materials in the country.   Pharmaceutical Policy The Pharmaceutical Policy has laid emphasis on indigenous research and development in the pharma sector. To provide encouragement, the policy has led to the establishment of the Pharmaceutical Research and Development Support Fund (PRDSF) under the Department of Science and Technology (DST). The DST has also constituted a Drug Development Promotion Board (DDPB) on the lines of the Technology Development Board to administer the utilization of the PRDSF. To encourage R&D, the Pharma Policy provides the following benefits to drug manufacturers: A manufacturer producing a new drug patented under the Indian Patent Act, 1970, and not produced elsewhere, if developed through indigenous R&D, would be eligible for exemption from price control in respect of that drug till the expiry of the patent from the date of the commencement of its commercial production in the country. A manufacturer producing a drug in the country by a process developed through indigenous R&D and patented under the Indian Patent Act 1970, would be eligible for exemption from price control in respect of that drug till the expiry of the patent from the date of the commencement of its commercial production in the country by the new patented process. A formulation involving a new delivery system developed through indigenous R&D and patented under the Indian Patents Act, 1970, for process patent for formulation involving new delivery system would be eligible for exemption from price control in favor of the patent holder formulator from the date of the commencement of its commercial production in the country till the expiry of the patent. To promote pharma education and training, the National Institute of Pharmaceutical education and Research (NIPER) has been set up by the Central government as an institute of "National Importance" to achieve excellence in pharmaceutical sciences and technologies, education and training. Through this institute, the government's endeavor will be to upgrade the standards of pharmacy education and R&D. Besides tackling problems of human resources development for academia and the indigenous pharmaceutical industry, the institute will make efforts to maximize collaborative research with the industry and other technical institutes in the area of drug discovery and pharma technology development.   National Biotechnology Strategy The National Biotechnology Strategy, which is awaiting the final nod of the Cabinet, is a big enabler for the biotechnology industry. Providing many fiscal and non-fiscal benefits to the industry, it is a road map for the next ten years in this sector. Some of its highlights are: 100 percent FDI approved in biotech units, which implies that there will be no restriction on the quantum foreign direct investment (FDI) in biotech companies and there may not be the need for FIBP (Foreign Investment Promotion Board) approval for equity investment in biotech companies; Gets a priority sector lending tag; International patent costs to get R&D weightage; DBT to set up 10 biotech parks with SEZ status among many others.   Patents Act With the third amendment to the Patents Act 1970 in 2005, India entered the product-patent regime and became TRIPS-compliant. The salient feature of the amended Act is that it provides for product patents unless otherwise excluded. Interpreted in the context of life sciences/biotechnology, plants, animals, seeds including essential biological processes used for propagating plants and animals are not patentable. Microorganisms, however, are patentable. Synthetic genes (as distinct from naturally occurring gene segments) and genetic interventions would now be the subject matter of patentability. Genetic interventions will include SNP (single nucleotide polymorphism), vectors, recombinant products such as vaccines, enzymes, hormones, etc. In order to get a patent, the Act requires the deposit of biological material with the International Depository Authority (IDA). IMT, Chandigarh is the IDA in India for some of the biological materials such as bacteria and plasmids. Apart from the above mentioned policies/acts, the Environment Protection Act, Industrial Policy, Science and Technology Policy and Recombinant safety guidelines are some of the other policy documents which support, facilitate and lay down a clear road map for the future development of the life sciences/biotech sector.   Rolly Dureha ]]> <![CDATA["We are in India to access the research talent"]]> https://biospectrumindia.com/news/95/1702/we-are-in-india-to-access-the-research-talent.html https://biospectrumindia.com/news/95/1702/we-are-in-india-to-access-the-research-talent.html Mon, 09 Apr 2007 14:25:00 +0530 New Page 1 "We are in India to access the research talent" Jan Lundberg has been heading the global research activities of the $26.5-billion AstraZeneca as the executive vice president (discovery research). A medical doctor and an accomplished researcher with over 500 scientific articles to his name, Lundberg was in Bangalore to inaugurate the new process R&D center of the company. He took time off to discuss with BioSpectrum Editor Narayanan Suresh, the importance of India in the company's research strategy which now focuses on "molecules in need" globally. AstraZeneca already has research centers in Europe and the US. Why are you doing more research work out of Asian centers like that in Bangalore and Shanghai? The company has made some strategic shifts in the research areas to concentrate on developing molecules in need widely around the world for major patient populations. So we have chosen to focus on tuberculosis (TB) at the center in Bangalore and cancer translational research in China. We have to be here to gain access to the talent available in these countries to do a large part of the drug discovery research. The Bangalore center has more than 100 researchers and the numbers will grow to nearly 200 in a short time. The Shanghai center is small right now with about 70 researchers. What is the difference a center, such as the one in India, will bring to the table? We could have done a lot of this work in Europe. But from India, we will be able access the talent, reach out to a range of key partners required in developing a drug against TB like academia, researchers and patients. We were highly impressed by the work done by the team in India in the early years and so we set up the process R&D center here itself. This kind of work requires a high level of passion and we find that in plenty along with talent in India. Since we are focused on developing a drug to cure a disease widely prevalent here, the motivational levels of the team involved is very high. With the recent advances in information technology, it is easier to connect teams working across the world faster, share their skill sets and leverage our technology platforms. This requires people with lots of skills in bioinformatics and that is available in plenty in India. How is the research work on TB progressing? The last major drug against TB was developed in the 1960s. Tuberculosis is different from many other bacterial infections. We are trying to understand the behavior of the organism better to be able to predict the onset of the disease. We are hopeful of good news in 2-3 years. ]]> <![CDATA[India Inc. attracting biotech investments]]> https://biospectrumindia.com/news/95/1146/india-inc-attracting-biotech-investments.html https://biospectrumindia.com/news/95/1146/india-inc-attracting-biotech-investments.html Mon, 09 Apr 2007 14:22:00 +0530 New Page 1 India Inc. attracting biotech investments Over the last few years, India has become a favored destination for global companies to set up their biotech facilities and expand their presence. Just in the last three months, several announcements have been made by global companies in the life sciences as a whole. For example, Syngene International, a subsidiary company of Biocon, has entered into a research partnership with Bristol-Myers Squibb to provide R&D services for discovery and early drug development. They will have a dedicated research facility at Biocon Park in Bangalore for this. This is one of the largest collaborations of its kind for Bristol-Myers Squibb. Nicholas Piramal India Ltd (NPIL) and Eli Lilly and Company (Lilly) signed a new drug development agreement to develop and, in certain regions, commercialize a select group of Lilly's clinical drug candidates that span multiple therapeutic areas. NPIL will be responsible for the design and execution of the global clinical development program, including IND-enabling non-clinical studies and human clinical trials up to Phase III. NPIL would receive a call-back payment, and potential milestone payments of up to $100 million, plus royalties on sales upon successful launch of the first compound. AstraZeneca inaugurated a $15-million state-of-the-art global process research and development laboratory (PR&D Lab) in Bangalore on March 21, 2007. This is the company's fourth PR&D facility and the only one outside of Europe. It was declared operational by AstraZeneca CEO, David Brennan. GlaxoSmithKline (GSK) and India-based IT major Tata Consultancy Services have signed an agreement to establish a global drug development support center in Mumbai, to help meet the demands of the growing GSK pipeline. Under a multi-year multi-million dollar contract, TCS will provide a variety of services in clinical research, including clinical data management and clinical submissions support. These are just a few examples to illustrate the growing confidence of global companies in Indian partners and in India. The reasons are obvious. India today has strong patent regime, governments supporting the industry, favorable policies, good infrastructure, and talent, among many things. Dr Francis Cuss, senior vice president, Pharmaceutical Research Institute, Bristol Myers Squibb, who laid the foundation stone for the facility at Biocon, said, "The company has mainly collaborated with Syngene to access the abundant talent that is available in India. This collaboration will also help us to sustain and boost our product pipeline." Commenting on the reasons for partnering with TCS, GSK's Dr Amber Salzman, senior vice president, development operations, said, "The strategic partnership with TCS represents a significant step towards GSK's vision of leveraging key talent globally to develop innovative medicines and GSK has chosen TCS because of its strong record in knowledge process outsourcing, underpinned by operational excellence. I am confident our collaboration will benefit both partners and, most important, help to deliver new medicines to patients." The engagements with global companies are a clear endorsement of the strategy of Indian firms to focus on services supporting the drug development processes and being global players. And the governments are supportive to the investments through infrastructure support and hassle-free clearances. For example, a "Knowledge City", which will house over 7,50,000 people engaged in cutting edge research in high tech areas and life sciences will come up in the suburbs of India's Silicon City Bangalore within 18 months. Another "Knowledge City" is being planned at Mohali spread over an area of 350 acres, which will comprise the National Institute of Nanotechnology, Indian Institute of Science Education and Research as well as an agri-food cluster. The DBT is involved in planning the agri-food cluster. The DBT will also support creation of incubators in biotech parks promoted by a private industry or through public-private partnership in the form of grant up to 30 percent of the total cost or up to 49 percent in the form of equity. A central body, Biotechnology Parks Society of India (BPSI), is also proposed to be set up for the promotion of biotechnology parks in the country. India already offers a good infrastructure. ICICI Knowledge Park and Shapoorji Pallonji Biotech Park are located in Genome Valley, Hyderabad and spread over 500 acres of land. The Andhra Pradesh government has also set up a marine biotech park on a 218-acre site near Visakhapatnam. Then, there is 200-acre Agri Biotech Park in the campus of the International Crops Research Institute for the Semi-Arid Tropics (ICRISAT). This park boasts of an Agri Business Incubator. Even Karnataka is setting up a biotech park located in the outskirts of Bangalore city. The first phase is on 90 acres of land and the second phase will have 106-acres. Further down south, there is Ticel Bio Park near Chennai, the capital city of Tamil Nadu. With 88 percent occupancy, the Park is looking at expanding capacity. In the coastal state of Kerala, the Kerala Industrial Infrastructure Development Corporation (KINFRA) is bullish on biotech infrastructure creation. Its biotech park near Kochi is a combination of Technology Incubation Centre and a Business Enterprise Zone. Moving up, in the west, there is a 110-acre International Biotech Park near Pune. This $55 million investment is a joint venture project between the Maharashtra Industrial Development Corporation (MIDC) and TCG Urban Infrastructure Holding Ltd (TCGUIH), a Chatterjee Group Company. Akruti Nirman and the TCG Group will develop a 700-acre biotech park at Savli near Vadodara in Gujarat. A special purpose vehicle (SPV) will also include the Gujarat government as a minority stakeholder and Akruti Nirman is expected to bring in Rs 200 crore as investment. In north India, Uttar Pradesh has made its move with the Lucknow Biotech Park. There is activity in Uttaranchal as well. This state is known for its rich biodiversity and is looking ahead at cashing it. In line with the Draft National Biotech Strategy other Indian states including Haryana, Himachal Pradesh, Madhya Pradesh, Gujarat, Rajasthan, Punjab, Orissa, West Bengal, Chattisgarh-all have definite plans and are forging ahead, creating infrastructure to leverage on the emerging biotech industry dynamics. The thrust today is on public-private partnerships.   ]]> <![CDATA[Finance Minister turns biotech-friendly again]]> https://biospectrumindia.com/news/95/1803/finance-minister-turns-biotech-friendly-again.html https://biospectrumindia.com/news/95/1803/finance-minister-turns-biotech-friendly-again.html Fri, 09 Mar 2007 11:58:00 +0530 New Page 1 Finance Minister turns biotech-friendly again The good news has come after some time, as this special 4th anniversary issue of BioSpectrum was going to print, from Finance Minister Palaniappan Chidambaram. He has chosen biotech among the few industrial sectors to give full attention in his Budget speech this time. And he listened to the voices from the industry after giving them a cold shoulder in 2006. So Chidambaram has given a thumbs up to many of the major demands of the industry in 2007. Biotech industry should count itself lucky this time as the finance minister has not listened to the demands of most of the other industrial sector this time. So the 150 percent weighted tax deduction for R&D expenses will continue till 2012. Of course, many were expecting him to raise the limit to 200 percent, which did not happen. The clinical trials sector gets exemption from the service tax. Biofuels will be fully exempt from excise duty, which will attract more investments into the sector and also make them more competitive vis-Ã -vis conventional fuels. Overall, the finance minister has listened to the industry's cries to be heard and seek recognition for its investments in innovation. So technology incubators will get service tax exemptions spurring the growth of specialized service providers. There is a whole list of other goodies and the industry's reactions too are captured in the current issue. Full credits for making the FM listen should go to S&T Minister Kapil Sibal and DBT Secretary M K Bhan for their tireless background efforts. Biotech industry can take comfort by the presence of many other well-wishers in the government. The current head of GEAC (Genetic Engineering Approval Committee), BS Parsheera, the IAS officer in the Ministry of Environment and Forests, has shed the bureaucratic shyness, and boldly outlined the regulator's position in probably the first ever media interview, given to BioSpectrum, to mark the 4th anniversary issue which is chronicling the five years of Bt cotton in the country. The GEAC chief deserves fulsome praise for demystifying the process of the regulation of transgenic products in the country, as well as for his clarity in the regulatory aspects of handling a controversial technology. There are many other firsts in this special issue, dedicated to the completion of the first five years of Bt cotton in the country. The first Bt cotton hybrid was approved for commercial cultivation on March 25, 2002. Almost all the key players in the Bt cotton saga, the companies and technologies who developed and marketed it, the regulators who approved the first transgenic product, the first farmers who switched over to the expensive but beneficial technology unmindful of the financial risks and the die-hard opponent of Bt cotton who has been calling for moderation, have been featured in this special issue. Bt cotton is indeed a remarkable success story in India despite various controversies as Indian farmers have overtaken the Chinese in planting these seeds last year. Chinese farmers are far ahead of technology adoption in almost every crop variety, except in Bt cotton. I would like to highlight three other firsts in the 4th anniversary issue. The richest Indian and head of the country's largest industrial enterprise, Mukesh Ambani, chairman of Reliance Industries, has exclusively shared his vision on the potential of biotechnology for India in a guest column. Ambani is highly optimistic about the opportunities offered by biotechnology and is confident that Reliance Life Sciences as well other biotech entrepreneurs will make it happen for the country in this sector. Second, Gujarat's Chief Minister Narendra Modi has outlined his government's innovative initiatives to extend the state's industrial dominance in other sectors to the technology of the future and explained the reasons for his coining the term BT +BT =BT (Bharat Today+ Biotechnology = Bharat Tomorrow) in yet another BioSpectrum exclusive. Lastly, the country's most well known and richest woman entrepreneur, Kiran Mazumdar-Shaw, turned a reporter for BioSpectrum to give a ringside view of the happenings at the high profile World Economic Forum meeting in Davos, Switzerland, in late January. With your continued encouragement and support, BioSpectrum will strive to achieve many more firsts in the forthcoming issues too.   <sureshn@cybermedia.co.in> ]]> <![CDATA["India is an important market for us"]]> https://biospectrumindia.com/news/95/2065/india-is-an-important-market-for-us.html https://biospectrumindia.com/news/95/2065/india-is-an-important-market-for-us.html Wed, 07 Mar 2007 15:51:00 +0530 New Page 1 "India is an important market for us" -Dr Ben Hwang, senior director, Asia Pacific, Invitrogen Corporation. Dr Hwang visited India in February to announce a marketing and distribution agreement with Imperial Life-Sciences (P) Ltd, Gurgaon (ILS). Dr Hwang shares with BioSpectrum, Invitrogen's plans and strategies. What do you intend to achieve in India through the tie-up with Imperial Life-Sciences? Invitrogen started in the US in 1987. Its purpose has always been to provide the technologies and products to allow the researchers to do research much faster and with greater efficiencies. This supports our company's quest-to provide best quality products and services to help improve human conditions. We believe in the quest and actually participate in work that saves life and improves people's quality of life. In 20 years, Invitrogen has grown to $1.3 billion in revenues and to 70 countries and provides a broad array of products and services. We have been on the top in terms of products, quality of service, innovation of business processes and technologies. The overall strategy has developed in such a way that Invitrogen wants to lead the industry in providing world class suite products that helps scientists do their jobs much more faster, efficiently, and effectively. They are not one off products. The essence of the strategy is to provide the scientific solution to a problem. We have a broad array of products from genome exploration to protein analysis, and to all the discovery stages in-between. With the acquisition of major industry players like Biosource, Caltag, Dynal Biotech, Gibco, Molecular Probes, and Zymed, Invitrogen serves the scientists around the globe to advance their discoveries. Though Invitrogen is a global market leader, it did not serve the Indian market. We wish to do that and this partnership is a step in that direction. Imperial Life Sciences, formerly known as Imperial Bio-Medics, is one of the fastest growing biosupplier companies in India and has been successfully serving the Indian scientific community for the past 17 years. Imperial Life Sciences' (ILS) ambition is to provide world class support and services and be the most preferred and leading supplier in India. How important are Asia-Pacific and India markets for Invitrogen? In order to deliver value to shareholders, Asia Pacific becomes very strategically important region for Invitrogen. This is because of the simple fact that a lot of scientific endeavors today, both in terms of biopharma outsourcing and academic research, are done in the region. The talent that countries like China, India, and Japan is unparallel. Second, Asia Pacific has the distinction of having the fastest growing markets ever anywhere in the world. Further, there are several public health concerns in the region that are being taken up very actively. This is why Asia Pacific is exciting for us as a company and critical for our success. India, in particular, is hugely critical for Invitrogen for several reasons. One, we have not done our part in serving the Indian market in the last couple of years. This is the reason why we have taken this big step with ILS. The Indian market is growing and exploding for three reasons-talent, cost, and patent protection. If you look at the trend of bioproduction, a lot of the bioprocessing is migrating to India. It is driven by the generic drug manufacturing tren ds. Further, as technology advances, India now has the ability to develop connoisseurs of therapeutics that are not chemical bases but biologics. That manufacturing process needs a lot of life sciences reagents like media, cell lines, sera, and vectors. That is being done hugely in India and the pharma companies are putting their emphasis on it. Further, India has tremendous traction in the worldwide scientific community. Indian scientists are populating around the globe and that talent would not be underutilized in the India market. All those factors drive a tremendous confidence in us that India is a market that will explode. And we want to participate in the market. Why did you select ILS as a partner? We did a lot of due diligence to find partners in India and we found ILS most suitable. Since our goal is not only to support the scientific community and actually be able to achieve our quest, but also to lead in a conversation around technology and how to solve a scientific problem and that requires a very special go-to-market model. It requires a partner that not only can understand the market and business transaction process but also has the ability to have the conversations on our behalf. ILS is very strong in that area. Second, ILS has a very strong logistics, infrastructure support and sub-dealer network. I am confident that ILS can fulfil the customers' expectations. Third, ILS brings a history of relationships in India. This partnership is more around my vision for India that Invitrogen products, technologies, and services are viewed as a critical scientific partner to the scientists the way scientists think. And the only way to accomplish that is to elevate the conversations to some of the most important leaders in the scientific community in India. Lastly, we feel Invitrogen is the market leader and what we do is to invest in the people so that they become better professionals to serve the scientific community. And Invitrogen and ILS are very much aligned in that regard. And if we executive well, which I am confidant about, then our dream in India will be realized and that vision is that the entire scientific community be proud off of us. Ch.Srinivas Rao   ]]> <![CDATA[MNCs dominate analytical balances market]]> https://biospectrumindia.com/news/95/8091/mncs-dominate-analytical-balances-market.html https://biospectrumindia.com/news/95/8091/mncs-dominate-analytical-balances-market.html Wed, 07 Mar 2007 15:43:00 +0530 New Page 1 MNCs dominate analytical balances market Major multinational players offering high-end analytical balances in India include Shimadzu, Mettler Toledo, Precisa Instruments, Ohaus Corporation and Sartorius. Besides these multinationals, there are about 10 local players who have been in the business of analytical balances for quite sometime. The major local players include Contech Instruments, Citizen Scales and Afcoset. The other players in this space include Suntech Analytical, Milton Instruments, Shambhavi Impex and Sensortron. Some of these local players have entered into tie-ups with multinationals for technology in developing analytical balances. For example, Afcoset, a Wadia group company has been in this business since 1988 by collaborating with A&D Co.Ltd of Japan. Similarly Citizen Scale has entered into an exclusive tie-up with a German company to market their balances under its brand name in India. Multinationals such as Mettler Toledo, Ohaus Corporation entered the Indian market through the dealership route. Now these companies have their direct operations in India. Precisa Instruments and Shimadzu continue to sell their range of analytical balances through distributors like Niulab Equipment and Amkette Analytics, a group company of ANM Alliance respectively. Sharing his views on the analytical balances market in India, Rakesh Valeja, product manager, Niulab Equipment Company, which has joined hands with Precisa Instruments AG, a Swiss company, in March last year, said, "The multinationals dominate the market share with over 75 percent of the analytical balances space while the rest belongs to the local players. This is mainly because of the accuracy and high quality that matter a lot in biopharmaceutical space." He continued, "The market for analytical balances has been on the rise and growing at 15-20 percent. About 2,000-3,000 units of analytical balances are sold every year. Half of these are in the high-end range while the rest are from medium to low-end range of products. In the high-end range, these balances are available at a price band of Rs 50,000-Rs 1.7 lakh and the medium range balances are available in the range of Rs 40,000- Rs 75,000 per unit." Features of analytical balances Self calibration system with respect to time and temperature Intelligent calibration mode Vacuum fluorescent display Density software User-friendly Source: Niulab Equipment Echoing similar views, Rajendra Parkar, product specialist at Amkette Analytics, which represents Shimadzu Analytical for whole range of balances in India, said, " The market for analytical balances is huge and growing at 22-25 percent. About 2,000 units are sold every year in a price range of Rs 80,000- Rs 1.5 lakh per unit." As noted earlier, these analytical balances are available in different segments such as premium, standard and budget. Premium segment balances fulfil the highest requirements with regard to measuring accuracy, standard features and use in quality systems: Standard Segment balances meet all the demands for practical performance of all weighing applications in the laboratory. And budget segment balances are rugged, easy-to-use balances that are ideal as school balances for the educational market, for use as a second balance, and for portable use in the field without line current. Analytical balances from Indian companies more or less are sold in the medium to low budget range as these balances are still not meeting the industry requirements. To overcome this barrier, they have to invest in R&D activities. At the same time the government should also encourage these companies by offering incentives to take up more R&D activities so as to build competency and to face the competition in the globalization era. There are hundreds of equipment manufacturers in India of which a few companies have already invested in R&D activities. The need of the hour is more incentives from the governments to enable these equipment manufacturers take up R&D activities.   ]]> <![CDATA[Biotech scholarships]]> https://biospectrumindia.com/news/95/5690/biotech-scholarships.html https://biospectrumindia.com/news/95/5690/biotech-scholarships.html Wed, 07 Mar 2007 15:37:00 +0530 Biotech scholarships Biotech scholarships The department of biotechnology (DBT) has several programs for scholarships/fellowships at the post-graduate, doctorate and the post doctorate level. DBT-JRF program The DBT has started a novel "DBT-Junior Research Fellowship" for pursuing PhD in any university/institute. It has launched "BET" or "Biotechnology Eligibility Test" on the lines of the National Eligibility Test (NET) for pursuing research in frontier areas of biotechnology and applied biology. The selected candidates can avail the DBT-Junior Research Fellowship. The Fellowship will be initially for a period of three years extendable for two more years based on performance. The Fellowship as JRF/ SRF will be in the range of Rs 8,000-9,000 per month and a research contingency of Rs 30,000 per year. The BET will be a written admission test, which will be conducted in April at centers in Chennai, Kolkata, New Delhi, Pune, Hyderabad and Jorhat (Assam). The students should have cleared the MSc/MTech/MVSc. (in biotechnology/bioinformatics) from any university approved by AICTE/UGC, MSc in Molecular Human Genetics. (BHU), Neuroscience (Jiwaji University) in order to be eligible to appear for this exam. Post-doctoral fellowship program The restructured DBT post-doctoral fellowship program is being implemented through the Indian Institute of Science, Bangalore, since April 2001. The selected fellows can opt to work in universities and R&D institutions of their choice. Under this program, post-doctoral fellowship of Rs 11,000 per PDF per month in the first year and Rs 11, 500 per month in the second year and a contingency grant of Rs 50,000 per PDF per annum is provided for the two-year period. Biotechnology Overseas Associateship The DBT has been pursuing the Biotechnology Overseas Associateship program to facilitate the availability of skilled scientists in adequate number. The program provides an opportunity to scientists for conducting advanced research or undergoing specialized research training in overseas research institutions/ laboratories in the priority areas of Biotechnology. The Overseas Associateship is awarded under two categories: long-term (for a period of one year) and short-term (for a period of three-six months). Biology scholarships The DBT provides biology scholarships to the top students in biology at the CBSE 10+2 level examination. Each scholarship award comprises a cash award of Rs 15,000, a gold plated medal and a certificate of merit. Every year 25 scholarships are awarded. Selection of the 25 students is made from the merit list provided by CBSE who are pursuing higher education in biology or related subjects after 10+2. Junior Research Fellowships Besides the scholarships offered by the DBT, the Council for Scientific and Industrial Research holds national level joint CSIR-UGC Examination (NET) normally twice every year, one in June and another in December. This examination determines the eligibility of Indian nationals for the award of Junior Research Fellowships (JRF) in science including biotechnology. Many of the state universities also offer scholarships/assistantship to students in this area of study. Innovative Young Biotechnologist Award The award has been instituted by the DBT as an attractive, career-orientation scheme to identify and nurture outstanding young scientists with innovative ideas and desire to pursue research in frontier areas of biotechnology. The award will consist of financial support for a project of three years duration besides a component of cash award/fellowship for the awardees. In addition, during the DBT Foundation day celebrations held in March 2006, Kapil Sibal, the Union minister for science and technology and earth sciences, announced a series of initiatives to enthuse students for higher studies in life sciences. This package includes assistance of Rs 50-60 lakh to select undergraduate colleges in life sciences. The ministry plans to support 20 undergraduate colleges across the country, one per state, for high quality teaching in life sciences. There is also a proposal to award 1000 undergraduate scholarships of Rs 500 per month for meritorious students from economically weaker sections to pursue career in life sciences. In addition, there will be a fellowship of up to $2,000 per month for post doctoral students wanting to do research in the high tech areas of stem cell technology and nanobiotechnology. There will be about 25 such special overseas fellowships. List of PG Colleges New Page 1 List of PG Colleges ]]> <![CDATA["LCRA will impart advanced knowledge on clinical research"]]> https://biospectrumindia.com/news/95/1939/lcra-will-impart-advanced-knowledge-on-clinical-research.html https://biospectrumindia.com/news/95/1939/lcra-will-impart-advanced-knowledge-on-clinical-research.html Wed, 07 Mar 2007 15:30:00 +0530 New Page 1 "LCRA will impart advanced knowledge on clinical research" -Sudhir Pai, managing director, Lotus Clinical Research Academy (LCRA) The number of biotech institutions is growing in India. The number of people passing out of the institutes is high. Yet, the industry is not able to find the right candidates. The most common reason cited is that the students passing out are not having industry orientation. The problem gets compounded further due to the diverse nature of the industry. The industry cuts across various sectors like the biopharma, bioagri, bioinformatics, bioindustrial and the bioservices, which call for different skill sets. To bridge this prevailing chaos and the gap between the demand and supply, several people from the industry have started academic institutions. BioZeen is a case in point, where top executives from Sartorius quit to start academic programs to train candidates who can be fit into the industry. Now we have Lotus Clinical Research Academy that has been set up as a joint venture between one of India's leading Clinical Research Organization (CRO), Lotus Labs and India's leading biosupplier Labindia, which will address the clinical research industry's requirements. Sudhir Pai, managing director, Lotus Clinical Research Academy Pvt Ltd (LCRA), shares with BioSpectrum about the programs that the institute has launched. When did you set up LCRA and who are the people behind the institute? LCRA was set up on January 15, 2007. The institute is a joint venture between Lotus Labs Pvt Ltd, Bangalore, Labindia Instruments Pvt Ltd, and a group of professionals with vast experience in the clinical research industry. The courses will commence from March. While Lotus Labs Pvt Ltd, which is wholly owned by Actavis hf, Iceland, one of the largest generic pharmaceutical companies in the world, would take care of the analysis part of the courses like biostudies, Labindia, an ISO 9001:2000 company, which represents leading global suppliers like Perkin Elmer, Applied Biosystems, and Leica in India, will take care of the lab part of training. What are the facilities in the institute and where is it located? The institute has been set up in Bangalore (Koramangala) and has the state-of-the-art laboratory equipped with sophisticated instruments like High Performance Liquid Chromatography (HPLC), liquid chromatography coupled with mass spectrometry (LCMS-MS) to provide hands-on-training in the modern techniques used by the clinical research and pharmaceutical industry. LCRA has a good library with the latest collection of national and international journals, besides the ambience of an actual CRO set up. What are the courses that you have launched? The courses have been designed in such a way that they suit the requirements of the industry and help the trainees to master the complex procedures in the area of clinical research. Currently we have three courses. One, a certificate course in Bio Analytical Techniques (BAT). Two, a certificate course for Clinical Investigators (CI). Three, a certificate course for Clinical Research Associates (CRA). What are the criteria for admission and is there an entrance test? There is no entrance test for the courses. It is on first come, first serve basis. The focus of our teaching is a 50:50 mix of theory and hands-on-training in all the courses. The duration of each of the courses and the qualification required to join them are different. We will not be taking more than 10 students per batch. BAT is a four-month fulltime course (five days a week). There will be practical assignment for the students along with the theory. The trainees will be training on HPLCs and LCMS and will be asked to develop methods and do validations. CI is a weekend course spread over three months (eight hours per week). It will help the medical professionals with practical exposure to designing protocols, studies, monitoring, and conducting clinical trials. CRA is a three-month fulltime course to train people to become successful clinical research associates. As mentioned earlier, we will not be recruiting more than 10 people per batch. The BAT course will see 60 students graduating every year. The batch starts after every two months. The CI and CRA batches start once in three months and 40 students will be passing out in each course every year. Would you facilitate placements? For the BAT program we have tied up with four companies for campus recruitment, which is done after two months of the progress of the course. The course fee for this program is Rs 1.75 lakh excluding the service tax. The student has to initially pay Rs 1 lakh plus taxes. And in case, the trainees get through the campus recruitment process, they would not have to pay the balance Rs 75,000. The recruiter pays the balance 75,000 to LCRA. In case, the trainee gets selected by Lotus Labs Pvt Ltd, the entire fee would be refunded, but the person has to work for two years.   ]]> <![CDATA[A global view]]> https://biospectrumindia.com/news/95/1511/a-global-view.html https://biospectrumindia.com/news/95/1511/a-global-view.html Wed, 07 Mar 2007 15:05:00 +0530 New Page 1 A global view Globally, the acreage of biotech cotton has been showing an increase year on year and has reached significant hectarage. The International Service for the Acquisition of Agri-Biotech Applications (ISAAA) brings out a status report on the global status of commercialized biotech/GM crops. Some excerpts from this report which give an overview of the world wide biotech cotton scenario. Of the 40 countries that grow cotton, a majority of area (75%) is occupied by six countries i.e. US, China, India, Pakistan, Brazil and Uzbekistan. Four countries US (37.5), Australia (7.2), Uzbekistan (10.3) and Brazil (5.2) occupy TWO-THIRD share of global export of cotton. Rest is shared by 34 countries. Nine major producer and exporter of cotton have adopted GM Cotton in 2006 (see map). The area planted to Bt cotton globally in 2006 was up 3.6 million hectares, equivalent to a 37 percent growth over 2006, the highest of all biotech crops, reaching 13.4 million hectares globally and equivalent to 38 percent of all the global area of 35 million hectares in 2006. Most (70 percent) of the 3.6 million hectare growth was in India (2.5 million hectares) followed distantly by the US (6,75,000 hectares), Argentina (285,000), and China (200,000) hectares. The significant growth overshadowed the biotech cotton decreases of 80,000 hectares in Mexico, due to seed import constraints, and 90,000 hectares in Australia, in line with substantial reductions of total plantings of cotton due to drought. Approximately 1,20,000 hectares of Bt cotton was grown in Brazil for the first time and this is expected to be a steep adoption curve similar to that witnessed in India and China to-date. The details about how biotech cotton is faring in some of the different countries that have adopted it is as follows: USA The US is one of the six "founder biotech crop countries" having commercialized biotech cotton, maize, soybean and potato in 1996, the first year of global commercialization of biotech crops. The total plantings of upland cotton at 6.0 million hectares in 2006 (the fourth highest in 30 years) were up seven percent on last year's 5.63 million hectares with growers increasing their hectarage of cotton in Mississippi, New Mexico, Arizona and California. The increase in biotech cotton was 675,000 hectares equivalent to a 15 percent increase and now occupies 88 percent of upland cotton in the US. The total plantings of biotech cotton in the US in 2006 at 5.3 million hectares are a record high in hectarage and adoption (88 percent). RR Flex cotton was introduced in the US and Australia for the first time in 2006 by Monsanto. It was marketed as a single gene and also as a stacked product with insect resistance in Bollgard II. RR Flex herbicide tolerant cotton was launched in 2006 on over 800,000 hectares. RR Flex cotton was planted as a single trait and as a stacked product with Bt, with the latter occupying the majority of the hectarage. The plantings were principally in the US with a smaller hectarage in Australia. The first ever biotech variety of American Pima Cotton, PHY 810 R, resistant to the herbicide RoundUp was planted in the US in 2006. The product was introduced by Phytogen, a joint venture between Mycogen Corporation and an affiliate DowAgroSciences LLC, and JG Boswell. It is estimated that PHY 810 R occupied approximately 5 percent of the American Pima cotton hectarage in the US in 2006. Argentina Argentina is also one of the six "founder biotech crop countries" having commercialized RR Soybean and Bt cotton in 1996. Argentina increased its reported area of biotech cotton in 2006 significantly to approximately 3, 60,000 hectares of which over 2, 70,000 hectares was Bt cotton and 90,000 hectares was herbicide tolerant cotton. Brazil The approval in 2005 of one biotech cotton event (BCE 531) in the variety DP9B allowed cotton growers in Brazil to legally plant Bt cotton for the first time in the 2006/07 season. This variety underwent field-testing in Brazil prior to the events that delayed registration due to legal considerations. In July 2006, another Bt cotton variety NuOpal was registered, thus two varieties were available in 2006. Input costs on cotton production in Brazil are very high with insecticides comprising up to 40 percent of the total production costs and involving up to 14 sprays per season. Brazil is expected to grow approx 1.2 million hectares of cotton in 2006 making it the sixth largest grower of cotton by area in the world after India, the US, China, Pakistan, and Uzbekistan. The adoption of biotech cotton in Brazil in 2006/07 was rapid and expected to reach high adoption rates in the near term as more adopted varieties become available and are approved for registration. China Like the US, Argentina and Canada, China is a member of the group of six "founder biotech crop countries" having commercialized Bt cotton in 1996, the first year of global commercialization of biotech crops. The national area planted to cotton in china increased from 5.1 million hectares in 2005 to 5.3 million hectares in 2006. This increase of 5 percent in total plantings resulted in a parallel increase in area of Bt cotton from 3.3 million hectares in 2005 to 3.5 million hectares in 2006, with percentage adoption of Bt at 66 percent, the same as in 2005. In 2005 approval was granted to grow one of the new hybrids, Yinmian 2 on about 700 hectares in the yellow river region in 2006. Notably the public sector in China has invested significantly in crop biotechnology and has developed Bt cotton varieties that share the market with varieties developed by the international private sector. The simultaneous marketing of biotech crops from the public and private sector is unique to China at this time but is expected to also become more prevalent in India as biotech crops are developed by government supported public sector institutions. South Africa Total cotton planting in 2006 were estimated at 22,000 hectares, similar to last year, of which 20,000 hectares or 92 percent were biotech cotton. Of the 20,000 hectares of biotech cotton, 13,000 hectares (65 percent of biotech cotton hectares) had stacked traits of both Bt and herbicide tolerance, 5,000 hectares (25 percent of biotech cotton hectares) were the single Bt and 2,000 hectares (10 percent of biotech cotton hectares) were herbicide tolerant , used mostly as refugia in Bt fields. Australia Australia is the fifth member of the six "founder biotech crop countries" having commercialized Bt cotton in 1996. Australia is expected to plant only 200,000 hectares of cotton in 2006 because of continuing severe droughts. It is projected that in 2006 about 66 percent of all cotton in Australia will feature the stacked genes for herbicide tolerance and insect resistance (the dual RR and BT gene Bollgard II-this will include a small area of RR flex; 17 percent with the dual Bt gene on its own, compared with 10 percent in 2005; 8 percent with a single gene for herbicide tolerance including some of the newly introduced RR flex cotton and the remaining 8 percent in conventional cotton compared with 10 percent in 2005. Australia has achieved the complete substitution of the single Bt gene product (Bollgard I) with the dual Bt gene varieties (Bollgard II) in only two years 2002/03. Mexico Mexico is the last of the six "founder biotech crop countries" having grown biotech Bt cotton in 1996. After a large increase in 2005 to 120,000 hectares biotech cotton hectarage in 2006 decreased to approx 55,000 because of regulatory delays that precluded the importation of biotech cotton seed for the early planting in Mexico. In 2006, biotech cotton in Mexico comprised Bt cotton (about 25,000 hectares), herbicide tolerant (HT) cotton (1,000 hectares) and the stacked traits of Bt /HT (30,000 hectares). Mexico is one of the four countries to deploy the Bt/HT stacked cotton, the other countries are the US, Australia and South Africa. Columbia Colombia introduced Bt cotton in 2002 on approx 2,000 hectares and in the interim this has increased consistently each year in 2003, 2004 and 2005 to reach 30,000 hectares in 2006, equivalent to almost 40 percent of the national cotton crop of 72,000 hectares in 2006. In 2006 Columbia also grew its first crop of herbicide tolerant cotton on approx 1,000 hectares. Chronology of Bt cotton in India New Page 1 Chronology of Bt cotton in India March 10, 1995: Department of Biotechnology (DBT) of the Government of India permits import of 100 gm of transgenic Cocker-312 variety of cottonseed cultivated in the US by Mahyco. This variety contained the Cry1Ac gene from the bacterium Bacillus thuringiensis.   April 1998: Monsanto-Mahyco tie up. Monsanto given permission for small trials of Bt cotton 100 g per trial by the Department of Biotechnology (DBT).   July 13,1998: LOI (Letter of Intent) by the DBT without involving GEAC. MAHYCO agrees to LOI.   July 27, 1998: Impunged permission by the DBT for trials at 15 locations, in August another 15 locations approved   November 16, 1998: News breaks of trials being carried out by Monsanto on Bt cotton without the permission of regional governments and without the consent of local communities.   November 28, 1998: Thousands of farmers occupied and burned down Bt cotton trial fields in Karnataka as part of Operation Cremation Monsanto.   December 2, 1998: About 200 farmers of Andhra Pradesh set fire to the experimental field of the "Bollgard" cotton crop raised by Monsanto in Urugonda village of Warangal district. The Andhra Pradesh government asks Mahyco Monsanto Biotech (I) Private Limited to stop forthwith the field trials of Bollgard gene seeds of cotton going on in seven districts in the state.   December 16, 1998: The "Monsanto, Quit India" campaign by various groups. Monsanto sues the Andhra Pradesh Raitha Sangha (Federation of all the farmer organisations of Andhra Pradesh) through its president, Malla Reddy.   January 6, 1999: Vandana Shiva's Research Foundation for Science, Technology and Ecology goes to the Supreme Court challenging the "illegality" of the field trials authorized by the DBT.   January 8, 1999: RCGM expresses satisfaction over the trial results at 40 locations and on April 12th directs MAHYCO to submit applications for trials at 10 locations before MEC.   May 25, 1999: Revised proposal top RCGM submitted to Mahyco   Juneâ€“November, 1999: Permission granted for different field trials. Oct-Nov: Shiva's group undertakes field visits.   May 2000: Mahyco writes to GEAC seeking approval for 'release for large scale commercial field trials and hybrid seed production of indigenously developed Bt cotton hybrids'.   July 2000: GEAC clears for large scale field trials on 85 hectares and seed production on 150 hecatares. Mahyco allowed to conduct large-scale field trials including seed production at 40 sites in six states. The permission was granted based on the "totally confidential" data from the small trials that allowed regulators to infer that Bt cotton was "safe." The DBT sets up committee to "independently" monitor and evaluate large scale field trials.   October 2000: RFSTE files application to amend petition challenging fresh clearance. Geeta Bharathan writes in Current Science on the controversy that evokes responses from scientists and Mahyco in subsequent issues.   Jan 5, 2001: A 10-member delegation comprising US judges and scientists meet Supreme Court Chief Justice AS Anand to educate him and other members of the judiciary on biotechnology.   June 18, 2001: An open dialogue held between Monsanto and Greenpeace to discuss Bt cotton with scientists, Ministry of Environment representatives and farmers. No data on field trials are presented, though farmers vociferously demand Bt cotton be commercialized. Technical questions and concerns raised by Greenpeace remain unanswered.   June 2001: PAN AP and others take urgent action at the request of activists both within India and abroad in protesting Mahyco/ Monsanto's aggressive attempt to fast-track governmental approval for Bt cotton commercialization. Some 300 emails were received from all over the world by the Indian government.   June 19, 2001: Genetic Engineering Approval Committee (GEAC) extends field trials of Bt cotton by another year. Mahyco conducts large-scale trials on 100 hectares in seven states.   October 2001: Mahyco discovers commercial Bt cotton farming over several thousand hectares in Gujarat. Source of the cotton is traced back to Navbharat Seeds Pvt Ltd.   October 2001: GEAC orders Bt cotton fields to be burnt in Gujarat. No action taken after farmers' protest order.   November 20, 2001: Gene Campaign files a case in the Delhi High Court charging the government with negligence in allowing large-scale field trials to be conducted without appropriate monitoring, regulation and safety precautions.   December 12, 2001: Sharma writes an open letter to the PM warning of the potentially devastating impact GE cotton seeds could have on farmers in India and the scientific fraud involved in the way the research trials have been conducted and monitored "the biggest scientific scam" to have ever hit India.   January 23, 2002: Dr Manju Sharma, secretary of DBT, declares that the latest round of Bt cotton trials were satisfactory and that it is up to the GEAC and the Ministry of Environment to decide on a date of commercial release.   February 20, 2002: The Indian Council of Agricultural Research (ICAR) submits a positive report to the Ministry of Environment on the field trials of Bt cotton. It is now expected that the Genetic Engineering and Approval Committee (GEAC) of the environment ministry will approve commerical use of Bt cotton within a month.   March 25, 2002: Approval given to Bt cotton by GEAC   May 2002: Piyush Patel of Navbharat seeds finally arrested. Monsanto ready to release another Bt-gene Cry2x also known as Cry2Ab for pest resistance in cotton. Expects clearance in India in three years. Rasi Seeds gets nod to conduct Bt cotton trials.   June 2002: Chinese environmental protection agency â€“ Greenpeace report showing fall in diversity index in Bt cotton fields, other pests increased. Several groups in India ask for ban on Bt cotton as a result through press release in Bangalore   August 8, 2002: Suman Sahai of Gene Campaign demands release of Bt cotton data   August 9, 2002: Government bans sale of Bt cotton seeds temporarily   August 24, 2002: First reports from Khargone of 100 percent failure of Bt crops (Shah and Banerjee)   April 2004: GEAC approves large-scale field trials and seed production of 12 varieties of Bt cotton hybrids developed by Rasi Seeds, Ankur Seeds and Mahyco.   April 2005: For the first time, six Bt cotton hybrids approved for cultivation in the North region. A total of 20 Bt cotton hybrids approved for cultivation in different regions of the country.   2006: GEAC approves 42 new Bt cotton hybrids for commercial cultivation taking the total to 62 Bt cotton hybrids approved for planting in the country. Of the 62 Bt cotton hybrids approved for commercial cultivation, 14 hybrids featuring three events were sold by six companies in the northern region, 36 hybrids featuring four events were sold by 15 companies in the Central zone and 31 hybrids featuring four events were sold by 13 companies in the Southern zone. Source: www.greenpeace.org/india and GEAC ]]> <![CDATA[Bt cotton is better, feel Dharwad farmers]]> https://biospectrumindia.com/news/95/7035/bt-cotton-is-better-feel-dharwad-farmers.html https://biospectrumindia.com/news/95/7035/bt-cotton-is-better-feel-dharwad-farmers.html Wed, 07 Mar 2007 15:00:00 +0530 New Page 1 Bt cotton is better, feel Dharwad farmers (L-R) Rudrappa Hulagannavar, Channabasappa Neeralakatti, Mahadevappa Andi, Gurupadappa Solagad, Basappa Barki, Shankargouda Badiyavar and Kutubshah Betageri of Hangarki village near Dharwad. The launch of Bt cottonseeds in 2002 has brought some cheer among farmers of Garag, Lokur and Hangarki, small villages close to Dharwad in Karnataka. They are again looking at cotton cultivation after having reduced the acreage under cotton because of high cultivation costs with no margins. Here is what they had to say. In the ensuing pages, we also bring reactions from farmers hailing from other states as well. Basappa Barki is a small farmer in a village called Hangarki, about 20 km from Dharwad in Karnataka, owning 2.5 acres of land. He has been cultivating cotton for years but in the 1990s due to low returns on investment. However, he restarted cultivating cotton in 2002, not with regular hybrids but with the newly launched Bt cottonseeds. "I came to know about this new Bt cotton seeds from an advertisement in a local newspaper in 2002. Since then I have been cultivating Bt cotton. Due to the drought during 2003 and 2004, we could not get a good crop. Otherwise I used to get 10-12 quintals of cotton as against only five quintals during drought, noted Basappa Barki. On the contrary, Ashok Desai, a businessman who owns 100 acres of farmland in the same village, has different views. He said, "I was cultivating non-Bt cotton (DCH variety) in about 40 acres during mid 1990s. Not satisfied with its performance (fall in the yields) over the years and other problems such as labor, I looked at other cash crops, mainly sugarcane during the early 2000 by reducing the acreage to cotton. When I came to know about the new Bt cottonseeds in 2002, I tried it the same year." He added, "I came to know about the launch of new Bt cotton seeds through Internet and tried with Mahyco Bt variety on three acres. The yield was good with about 8-9 quintals per acre. As the Bt cotton has short staple, the price for this was on the lower side. It fetched Rs 2,000 per quintal, comparatively lesser than the non Bt variety." Ashok Desai continued, "Though the yield was good, I could not continue with Bt cotton from 2003 as it was not cost effective. The failure of monsoon and regular labor problems encouraged me to look at other cash crops like sugarcane in the irrigated land." The same is not true in case of Sankappa Shigihalli, who has 150 acres of dry agriculture land in Garag village, where Monsanto has a 150-acre field trial facility. Sankappa has started sowing Bt cotton only in 2006 kharif after recommendations from his neighbor Bhimappa Tigadi who has been using Paras Brahma since 2004 kharif season. Incidentally Garag has had the history of being the sole producer of the National Flag and the hand-woven khadi for the manufacture of National Flag since 1956. Sankappa Shigihalli said, We purchased only three packets of Paras Brahma Bt cotton, that too at the fag end of the sowing season i.e. during July 2006. He happily adds, "We are getting good yields with good returns too." On asking about the yields, Sankappa noted, 25 quintals for three acres. "This year the rates for cotton are on lower side and we got Rs 2,250 per quintal." Shigihalli has been cultivating soya, maize, groundnut, onion, potato and sugarcane along with cotton (non-Bt variety) in about five-six acres in his dry agricultural land. To get good returns on investment, he has been spraying pesticide 10 times. For each spray, he has been spending Rs 500 per acre per spray. Now with the Brahma Bt, he said, "We just spray for two times during the entire crop season. Happy about adapting to this new Bt cotton, he said, "We have so far not come across any side effects of Bt cotton on animals as we have allowed small animals for grazing in our fields. This year we will increase the acreage for cotton to 5-6 acres. Manjunath Shigihalli, the youngest brother of Sankappa, a teacher at a primary school in the same village, said, "The children have a lesson on the basics of biotechnology and its application. They are keen to know more about it and also DNA etc. Sharing his views on the Bt cottonseeds, Bhimappa Tigadi said, "I was one among few farmers of Garag to get free Bt cottonseeds along with two other non-Bt varieties in 2004-05 for trials in ¼ acre (10 guntas). After realizing the merits of this Bt cotton (Brahma) for two years, I decided to buy the Bt cottonseeds at Rs 750 per packet in 2006. Now most of the farmers in our village are using this new Brahma Bt variety. Bhimappa Tigadi said, "During the last kharif season, I had cultivated Brahma in four acres and one acre with DCH variety. The yield for the Brahma variety was good with 12-quintals/acre while for DCH variety, I got just five quintals/acre. The rate for Brahma is comparatively less against the non-Bt variety, which has long staple. In spite of this, I will go for more of Bt cotton this season due to less number of sprays and more yield. Similarly Channabasappa Neeralakatti, a school teacher and also having a small agriculture land of five acres at Hangarki village has been sowing Bt cotton since 2005. He said, I purchased two packets of Bunny Bt for Rs 1800/packet in 2005 and thanks to the Supreme Court's intervention as we got the Bt seed packet at Rs 750/packet in 2006. He further said, "It started with just three-four farmers in 2002. Now 90 percent of the farmers in our village are using Bt cotton seeds like RCH-2, Mallika, Brahma, Bunny Bt, Mahyco â€“Bt etc." The situation is the same in Lokur village, a familiar name that came to limelight when the BBC crew members visited this small village to feature the Narasingannavaras, the largest joint family in India. The farmers in Lokur are now turning to Bt cotton. It was Veerabhadragouda Patil, a progressive farmer with over 100 acres of agriculture land who brought cotton to this village for the first time in 1975 and also tried with Bt cotton in his fields in 1998 at a time when the Karnataka Rajya Raitha Sangha (KRRS) activists had burnt the Bt cotton trial fields in Bellary, as part of Operation Cremation Monsanto. Mallangouda Patil, a son of Veerabhadragouda Patil, said, "My father was the first to introduce cotton to our village way back in 1975. Thereafter we were covering cotton in about 40-50 acres out of 100 acres of dry farmland. We used to get good returns initially. Gradually with fall in yields, increase in costs of cultivation and continuous drought-like situation pushed us to look at other crops like groundnut, potato, green dal etc. In 1998, our father also bought a packet of Bt cottonseeds when trials were going on and tried with new Bt variety without bringing it to notice of the other farmers. "Again in 2005 we tried with Rasi's RCH â€“2 in one acre and the yield was satisfactory with 6-quintals/ acre. We increased the acreage in 2006 kharif by buying 12 packets of Mahyco's Bt cotton by paying at Rs 1,450 per packet. Drop in the price of Bt cotton supported us to buy few more packets of the same variety that we distributed to other farmers in the village. We are happy with the performance of Mahyco's Bt (8-9 quintals per acre). The rate for this cotton was also good as we got Rs 2,200 per quintal." Shivangouda, Mallangouda's brother, said, "This year we are not getting a good rate for cotton. Earlier the rates had crossed the Rs 4,000 mark. However, less number of spraying (twice per season) and good yields support us to look at this new Bt cotton." Considering the positive results of Bt cotton, Mallangouda said, "Bt cotton is better over the non-Bt variety. And we are looking at covering about 20 acres with Bt during the coming kharif season." Mahesh Kittur, a small farmer from Hangarki with 10 acres of dry agriculture land, wishes to shift to Bt cotton and he's not an exception. Kittur, who used one packet of Bunny Bt last year by buying it at Rs 750, said, "In the coming kharif season, I will buy two packets of Mallika and increase the area under cotton." Besides Basappa Barki, Kittur and Neeralakatti, other small farmers with land holdings of 5-10 acres such as Rudrappa Hulagannavar, Gurupadappa Solagad, Shankargouda Badiyavar have expressed happiness over the performance of Bt cotton and are looking forward to increasing the acreage under cotton in the coming years. On the other hand, Mahadevappa Andi, a small farmer with 14 acres of land at Hangarki, who also does 'Lavani' (cultivating other' lands for rents or share cropping for specific period) was a bit unhappy with the way the seed companies treat the farmers. He cultivated cotton in about 5-6 acres with Bunny Bt in 2006. An agitated Mahadevappa Andi said, "In 2005, Nuziveedu Seeds had organized 'Kshretrotsava' (a regional agricultural fair) on the fields of Channabasappa Neeralakatti, inviting farmers from the neighboring districts. It was a gathering of over 1,500 farmers. During that year they had regular field visits and regular plot supervision was done. As a result, more and more farmers bought packets of Bt cottonseeds the following year. In 2006 we came across uneven growth of the plant and also the size of the bud. In spite of our please to the companies, not a single representative turned up to help us." Sharing his views on the issue, Channabasappa Neeralakatti said, "We were able to bring an agri scientist from the University of Agricultural Sciences, Dharwad, to our fields, who on observation told us that it might be due to mixture of different varieties of Bt cotton seeds taken from different fields/ plots. Mahadevappa was not very convinced with the answer. He said, "I strongly feel about the possibility of mixing of spurious seeds with genuine Bt cotton seeds. He even questioned the seed firms for not making efforts in making the farmers aware of the situation and helping them in identifying the genuine Bt cotton seeds. The above views from farmers clearly indicate that they are ready to accept the change and adapt the new technologies as long as they are benefited. They too have to move with the changing situations in a global village to lead a better living. Keeping this in mind, the companies, the governments and other related agencies should make sincere efforts in bringing about awareness on the latest technologies available for farmers who undoubtedly form the "backbone of our society. Narayan Kulkarni in Dharwad Punjab's Bt cotton cultivators are optimistic Bt cotton was approved for commercial sale in the Northern part of India in 2005. With the widespread success of Bt cotton in the state of Punjab, it became a big election campaign tool in the recent assembly elections to mobilize mass farmer support for Capt Amarinder Singh, Chief Minister of Punjab. As the polls neared, Bt cotton was touted as the reason for the rising prosperity in the Malwa region (north-western Punjab). Here is a direct feedback from a Punjab farmer who has been growing Bt cotton in her fields for two seasons. Suman Taneja is a 45 year-old educated farmer hailing from Kandwala Amarkot village, about 8-9 km from Abhore at the Punjab-Haryana border, in district Firozpur, Punjab. In addition to managing her 20-acre field, this political science postgraduate with a bachelor in education (BEd), also teaches English to primary students in a nearby-recognized private school. She is a seasoned cotton farmer, growing cotton in the kharif season and wheat in the Rabi season along with some fodder crops. Suman's family has been growing cotton in their farm since Independence and she was among the first few farmers in her village to adopt Bt cotton in 2005, the year it was approved for commercialization in Punjab. "One of my cousin brothers is a research officer at the Punjab Agricultural University, Ludhiana. He was the one who had initially advised me to plant Bt cotton in 2005", she said. "That year, I experimented with Bt cotton (Rasi Seeds-RCH-134) in 5 acres. Though the seeds were expensive, about Rs 1,749 a packet, the yield was good. The plants achieved good height, demanded less water, and just one or two rounds of insecticide spray as compared to eight-10 round of sprays on the other regular varieties. The cotton balls were also bigger and softer. Even the workers doing the picking were happy as they managed to pick more cotton in a day." When asked about how do the Bt cotton varieties compare with the non-Bt varieties, she clarified, "I was earlier planting hybrid cotton varieties. These also gave good yields but were quite susceptible to pests, in particular to the American Bollworm complex. Encouraged and enthused by the results that she saw in 2005, the following year she decided to increase the acreage of Bt cotton in her fields. In 2006, Suman planted Bt cotton (RCH-134, MRC-6301 and MRC-6025) on eight acres of land. She also tried an unapproved Bt cotton variety from Gujarat on 3.5 acres and the regular hybrid variety (from Rasi Seeds) on five acres. Once again, she was not disappointed with the yield from Bt cotton, although the weather turned bad with heavy rains and hailstorm at the time of the cotton-picking leading to a lot of ball dropping and wastage. "The yield was about 12 quintals/acre and if the weather had been good, it would have touched about 16 quintals/acre", she said. According to her, even the illegal variety gave good results, but it required a lot of water as compared to the Rasi Bt cotton variety. Comparing and contrasting the upbeat mood of the farmers in Punjab today with that ten years ago, she commented, "Ten years ago, the cotton farmers were facing a grave problem due to the various pests, which used to damage the standing crop very badly. And they were not being controlled by any mechanism. Those were uncertain and trying times for us. The situation has vastly improved since the last four-five years with better hybrids, effective pesticides and now the Bt cotton." "The main advantage with Bt cotton is that I can manage my fields better with significantly lesser sprays. There is less pest infestation leading to a good yield. Now I can be more relaxed, there is less tension and uncertainty and I can spend more time with my family." But Suman strongly feels that the cost of the Bt cottonseeds should come down. "On an average, the hybrid seeds are available for Rs 400 per packet, whereas I had bought the Bt cotton seeds for Rs 1,700-1,750 in 2005 and Rs 1,140 in 2006 per packet. And it takes two packets to sow one acre of land. At the time of sowing, it becomes difficult to arrange money to buy Bt seeds in bulk. Also, many a times it rains just after sowing and in such cases we have to prepare the fields again and do re-sowing. The cost of the seeds should be less so that even the small farmers can purchase these seeds easily", she said emphatically. Another issue that she points is the availability of Bt cotton seeds at the time of sowing. "Due to the high demand for seeds in the sowing season, many a times they go out of stock. There should be a proper distribution system in place to ensure a reliable steady supply of seeds," she said. The Bt cotton has fetched her a price in the band of Rs 2,100-2,400 per quintal in 2006 and although she has not been able to make any substantial savings till now, she is optimistic about the good income generation in the future. In the coming season, a confident Suman plans to increase the acreage of Bt cotton in her fields and would advice the farmers to try Bt cotton. Rolly Dureha Tamil Nadu farmers give thumbs up to Bt cotton New Page 1 Tamil Nadu farmers give thumbs up to Bt cotton The area under cotton is increasing as most of the farmers who have opted out of cotton cultivation due to the pest incidence are now coming forward to cultivate Bt cotton. Here are some cases of farmers from Tamil Nadu reflecting their faith in Bt cotton. VKV Ravichandran, Nallamangudi, Nanilam, Tiruvarur district "I have been cultivating variety and hybrid cotton since 1995 in the rice fallow, as irrigated cotton. When the Bt cotton was introduced in 2002, I was apprehensive about it. On February 21, 2004, I happened to attend a seminar organized by SICA at Coimbatore, and listen to the lecture presentation by Dr TM Manjunath, the then director of Monsanto Research Center. And that year I took up sowing of Bt cotton in about one acre. On seeing the Bt cotton free from bollworm menace, I decided to take up Bt cotton in more area. Since then, I have been taking up Bt cotton in about 12 acres every year. In 2005 and 2006, I raised RCH2, RCH20 and MRC 6918 BT hybrids. I experienced a quantum jump in yield, profitability and quality by taking up Bt cotton. I achieved a maximum yield of 16 quintal per acre of RCH 2 BT, 14 quintals of RCH20, and 12 quintals of MRC 6918 ELS Bt cotton. Until I started cultivating Bt cotton, I could not achieve the potential yield of any variety despite my sincere efforts. Boll shedding is the major cause for the yield loss. Though the squares and bolls shed due to several factors, bollworm attack is a major reason for the reduced yield, accounting for nearly 50 percent of the boll shedding. The Bt cotton does not guarantee direct increase in yield level, but the near absence of ball shedding due to bollworm helps us to realize the potential yield. Further, I spent lesser on sprays to control bollworm. I could save about Rs 1,200 per acre. It is our fond hope that GM crop researches should evolve. Balachandran, Okkarai, Tiruchirapalli district Balachandran cultivates on about 16 acres, with six acres under irrigation and 10 acres under rainfed. This farmer had been cultivating Cotton Suvin, LRA 5166 and RCH 2 in the past and because of the severe incidence of pink bollworm he stopped the cultivation of cotton. After introduction of Bt cotton, in the year 2004 he cultivated RCH 2 Bt cotton and obtained an average yield of 13 quintals per acre. The net profit per acre was Rs 13,600. "I got the information about the release of Bt cotton through All India Radio and a newspaper. I contacted the company representative and obtained seeds for four acres. The crop came up very well and I did not spray any plant protection chemical for the control of bollworms. I used to spray not less than 10 times previously for non Bt cotton. The bolls burst in full with good white colour and it gave me Rs 100 more for the good quality. From then on, I am regularly cultivating Bt cotton like RCH 20 Bt and RCH B 708 Bt. Because of me many farmers in my village have switched over to Bt cotton. Bt cotton gives me peace of mind and more money since the bollworm attack is eliminated". Last year this farmer obtained 19 quintals of yield with RCH B 708 Bt cotton in one acre and was given a prize by Rasi Seeds for the excellent results. Balachandran was happy that the labourers did not complain about the problems associated with the harvest like pest affected bolls, unopened bolls etc. and this allowed them to collect more kapas thereby getting more money. V Kumaresan, Oduvankuruchi, Rasipuram "I have been cultivating cotton for the past 10 years. I suffered very much because of the plant protection problem. Every week the crop had to be sprayed. I stopped cultivating cotton at one stage. But during last year, we got 16 quintals per acre from RCH 2 Bt. We were getting only four quintals per acre previously and with Bt technology now the yield has gone upto 16 quintals per acre. Bt cotton is profitable. There is good boll setting and there is uniform bursting from the bottom to top. There is no pest attacked boll. So a good price is obtained. We cannot differentiate between Bt and non Bt plants both look alike. But in Bt plants, the bolls are set uniformly and there are no drops. About 90 percent of the bolls in Bt cotton come to bursting. Since Bt cotton is not affected by the bollworms we are able to get 10 quintals per acre compared to non Bt cotton where one got five-six quintals per acre. In the past, if I grew five acres of cotton, I would spend Rs 50,000 for pesticides and Rs 20,000 for fertilizers and I would receive Rs 1 lakh from it. The other expenses would come to Rs 30,000 and there was no profit. Now I spend very less for plant protection that it self is profit to me. I spray only thrice. There is total peace of mind for me now and I am recommending Bt cotton to my neighbors."   Farmers like Bt cotton Tamil Nadu Lakshmipathi Somanahalli Palacode is a 40 year-old farmer in Dharmapuri, Tamil Nadu. He is also a diploma holder in Civil Engineering and is currently serving as the secretary of Abhiyaman Procession Farming Association, Dharmapuri. Lakshmipathi has been cultivating Bt cotton for the past four years using the Mahyco Trial Cotton and RCHB 708 hybrids. The maximum yield of his crop from these hybrids has been 10 quintals leading to Rs 23,000 as profit in account. VKV Ravichandran Nannilam is a 48 year-old farmer in Nannilam, Tamil Nadu. He is also a graduate in Maths and has also completed a certificate course in cotton cultivation. Ravichandran is currently serving as the secretary of the sugarcane forum, Nannilam and is also a member of Paddy, Sugarcane, and Cotton Lions Club. He has been cultivating Bt cotton for the past three years using the RCH 2, RCH 20 and MRCH 6918 hybrids. The maximum yield of his crop from these hybrids has been 16 quintals leading to Rs 21,000 as his profit in account. Maharashtra Dr Dilip Adhar Patil is a 47 year-old farmer from Dangari, Jalgaon. He is a qualified Doctor of Homeopathic Medicine and Science (DHMS). Dr Patil has been cultivating 125 acres of irrigated land for the past 22 years and he has been using Bt technology for the past five years. Bhagwan Nathu Patil is a 32 year-old farmer from Malpimpri, Jalgaon. He has been educated till ninth standard and is also the sarpanch of Malpimpri. Patil has been cultivating eight acres of irrigated land for the last 15 years and has been using Bt technology for the last three years. Bhagwan Shankar Patil is a 30 year-old farmer from Pimpale Sim, Jalgaon. He has been educated till higher secondary (12th Standard). Patil has been cultivating 70 acres of irrigated land for the last seven years and has been using Bt technology for the last three years. Vijay Tukaram Patil is a 44 year-old farmer from Tonde, Dhule. He has been educated till tenth standard. Patil has been cultivating 46 acres of irrigated land for the last 17 years and has been using Bt technology for the last four years. Sureshbhai Sakharambhai Patel is a 37 year-old farmer from Phes, Nandurbar. He is a qualified MCM. Patel has been cultivating 52 acres of irrigated land for the last 22 years and has been using Bt technology for the last five years. Andhra Pradesh Veeraswamy is from Penagunda village, K Samudram village, K Samudram Mandal, Warangal district. "I have planted both Bt and non-Bt varieties last year. Pest incidence is low in Bt cotton compared to non-Bt cotton. Bt cotton plants had around 300 flowers per plant which lead to good yield and income. Adhi Reddy belongs to Sitammapet village, Atmakur mandal. Warangal district. He hails from a family of farmers where several successive generations have been tilling the land. Reddy has himself been farming for the past 17 years and has been using Bt cotton for the past few years. He has had a positive experience with Bt cotton. "I am cultivating Bt cotton for the last three years. I have almost stopped spraying pesticides because Bt varieties are resistant to Bollworm. As I have stopped spraying insecticides, the population of useful insects has increased in my field. I save Rs 4,000 per acre by this practice." V Venkateshwar Reddy hails from Upparapalli Village, K Samudram Mandal. Warangal district. He has over 15 years of experience in cotton farming and is cultivating 10 acres of land with Bt cotton. His experience with Bt cotton has been good especially in the past few years where he has seen increased yield. "Reduction of seed prices to Rs 750 per packet is more useful for farmers. We have to grow Bt cotton only". Lakakula Satyanarayana is another Bt cotton farmer from K Samudram village, K Samudram Mandal, Warangal district. "I cultivated Bt cotton last year. Other farmers sprayed more pesticides for their non-Bt crop which led to huge losses. I did not spray insecticides to my Bt crop which helped me in realizing high income." Kaki Rami Reddy, K Samudram village, K Samudram Mandal, Warangal district, too favors Bt cotton. "I got 30 quintals of lint from one acre of Bt. I sprayed insecticide only once. I have decided to grow only Bt cotton this year and not to spray insecticides." Source: Federation of Farmers Associations Meet in Warangal, AP. ]]> <![CDATA[India beats China in Bt cotton cultivation]]> https://biospectrumindia.com/news/95/1621/india-beats-china-in-bt-cotton-cultivation.html https://biospectrumindia.com/news/95/1621/india-beats-china-in-bt-cotton-cultivation.html Wed, 07 Mar 2007 13:38:00 +0530 New Page 1 India beats China in Bt cotton cultivation For the first time, India grew more Bt cotton (3.8 million hectares) than China (3.5 million hectares) and moved up the world ranking by two places to number five in the world of biotech crops, overtaking both China and Paraguay. Cotton cultivation in India covers an area of approximately 9 million hectares, representing about one quarter of the global area of 35 hectares under cotton. Cotton is cultivated by four million small farmers and involves many more in the processing, textile manufacture and trade. However, the average yield of cotton, 440 kg/ha, is far below the world average of 677 kg/ha and the production is only about 16 percent (4.13 million tons) of the world production of 26.19 million tons. The main losses in cotton production are due to its susceptibility to about 162 species of insect pests and a number of diseases. Among the insects, cotton bollworms are the most serious pests of cotton in India causing annual losses of at least $300 million. It is estimated that insecticides worth $660 million are used annually on all crops in India of which more than half are used on cotton. For example, in 2001, the cost of 21,500 metric tons of insecticides used on cotton was worth $340 million. Further, among the cotton bollworm complex, the American Bollworm or the Helicoverpa armigera is the most destructive pest and has developed resistance against most of the recommended insecticides. This has forced the farmers to apply as many as 10-16 insecticide sprays on the crop. Organizations working on Bt cotton (under development & field trials) Organization Transgene Ankur Seeds P Ltd, Nagpur cry1Ac; cry1Ac & cry2Ab Ajeet Seeds, Aurangabad cry1Ac; cry1Ac & cry2Ab Ltd, Hyderabad cry1Ac; cry1Ac & cry2Ab Emergent Genetics Ltd, Hyderabad cry1Ac; cry1Ac & cry2Ab Ganga Kaveri Pvt. Ltd, Hyderabad cry1Ac JK Agri Genetics, Hyderabad cry1Ac Krishidhan Seeds, Jalna cry1Ac; cry1Ac & cry2Ab Mahyco, Mumbai cry1Ac; cry1Ac & cry2Ab Metahelix, Bangalore cry1Ac Nandhi Seeds Ltd, Hyderabad cry1Ac Nath Seeds, Aurangabad GFM cry1Aa Nuziveedu Seeds, Hyderabad cry1Ac; cry1Ac & cry2Ab Namdari Seeds Ltd, Bangalore GFM cry1Aa Pravardhan Seeds, Hyderabad cry1Ac Prabhat Agri Biotech Ltd, Hyd. cry1Ac; cry1Ac & cry2Ab Rasi Seeds Ltd, Attur cry1Ac; cry1Ac & cry2Ab Safal Seeds Ltd, Jalna GFM cry1Aa Syngenta India Ltd, Pune Vip-3a Tulsi Seeds, Guntur cry1Ac; cry1Ac & cry2Ab Univ. Agri. Sciences, Dharwad cry1Ab Vibha Seeds Ltd, Hyderabad cr1Ac Vikki's Agrotech, Hyderabad cry1Ac Vikram Seeds Ltd, Ahmedabad cry1Ac Zuari Agrotech Ltd, Bangalore , GFM cry1Aa The Genesis In this scenario, incorporating insect resistance has been an important objective in the cotton improvement efforts. In 2002, after extensive testing, Bt cotton was introduced for commercial cultivation in the country for a period of three years, till March 2005. Bt cotton is a variety of cotton genetically modified to contain a gene (cry1Ac) of Bacillus thuringiensis (Bt), which is foreign to its genome and is a naturally occurring soil bacterium used to control Lepidopteran insects because of a toxin it produces. Splicing this gene within the genetic structure of cotton makes the cotton plant poisonous to the boll weevil, the notorious cotton pest. The US-registered multinational corporation, Monsanto, first developed Bt cotton and three genetically modified cotton hybrids (Bt Mech 12, Bt Mech 162 and Bt Mech 184) developed by Monsanto in collaboration with its Indian partner Mahyco were released for commercial cultivation in central and southern India in 2002. India approximately grew 50,000 hectares of officially approved Bt cotton hybrids for the first time in 2002, and doubled its Bt cotton area to approximately 1,00,000 hectares in 2003. During April 2004, the Genetic Engineering Approval Committee (GEAC), the regulatory authority for transgenic crops in India, approved RCH 2 Bt developed by Rasi Seeds for commercial cultivation in central and southern parts of India. With this, RCH 2 Bt became the fourth transgenic cotton crop to be approved for commercial cultivation. This resulted in an increase of the total Bt cotton area in the country by fourfold in 2004 to reach half a million hectares. In addition, during 2004, GEAC approved 12 Bt cotton varieties in the country for large-scale field trials and seed production: RCH 118 Bt and RCH 559 Bt in central India, RCH 368 Bt in south India and RCH 317 Bt in north India by Rasi seed; Ankur 651 Bt and Ankur 2534 Bt in north India, Ankur 651 Bt and Ankur 09 Bt in central India by Ankur seeds; and MRC 6301 Bt, MRC 6160 Bt in central India and MRC 6301 Bt and MRC 6322 Bt in South India by Mahyco. The players Presently the 62 approved hybrids are being marketed by the following seed companies from India: Mahyco (MECH and MRC) Rasi (RCH) Ankur Seeds (Ankur) Nuziveedu Seed (NSC) JK Seeds (JKCH) Nath Seeds (NCEH) Ganga Kaveri Seeds (GK) Tulasi Seeds (Tulsi) Ajeet Seeds (ACH) Emergent Genetics (Brahma) Vikki Agrotech (VCH) Pravardhan Seeds (PRCH) Krishidhan (KDCHH) Prabhat (PCH and NPH) Vikram Seeds (VICH) All the Bt cotton hybrids developed by these three companies contained Bt cry 1 Ac gene developed by the US seed multinational, Monsanto. While Mahyco has been Monsanto's partner in India, Rasi Seeds and Ankur Seeds are sub-licensees of Monsanto. Increasing the spread In April 2005, the GEAC approved six new Bt cotton hybrids for commercial cultivation in northern India. In May 2005, post reviewing the performance of the three Bt cotton hybrids commercialized by Mahyco Monsanto Biotech (MMB) during the period 2002-2005, the GEAC renewed permission for MMB to market MECH-12 Bt, MECH-162 Bt and MECH-184 Bt in the central zone (Madhya Pradesh, Gujarat and Maharashtra) for another two years. It approved cultivation of MECH-162 Bt and MECH-184 Bt in Tamil Nadu and Andhra Pradesh, but not of MECH-12 Bt. In addition, for central India, five new hybrids were approved for commercial cultivation - RCH-144 Bt and RCH-118 (of Rasi Seeds), MRC-6301 Bt (Mahyco) and Ankur-681 and Ankur-09 (Ankur Seeds). For the south, Mahyco's MRC-6322 Bt and MRC-6918 Bt and Raasi's RCH-20 Bt and RCH-368 Bt were approved. In 2005, the area under Bt cotton in India continued to climb reaching 1.3 million hectares, an increase of 160 percent over 2004. The GEAC also approved 20 large-scale field trials for different types of Bt cotton in south and central India. Significantly these trials included the testing of three different "events" via the JKCH-1947 of JK Agri Seeds (Containing cry1Ac event 1 developed by the Indian Institute of Technology Kharagpur), NECH-6R Bt of Nath Seeds (containing fusion genes cry1Ab/cry1Ac from China) and 02-50 VIP of Syngenta Seeds in north India. Current scenario According to latest survey findings of The International Service for the Acquisition of Agri-biotech Applications (ISAAA), in 2006, the record increase in adoption continued with almost a tripling of area of Bt cotton to 3.8 million hectares. In 2006, this tripling in area was the highest year-on-year growth for any country in the world. Notably, India's Bt cotton area in 2006 (3.8 million hectares) exceeded for the first time with that of China (3.5 million hectares), the third largest cotton producer in the world. Of the 6.3 million hectares of hybrid cotton in India in 2006, which represented 70 percent of all the cotton area in India, 60 percent or 3.8 million hectares was Bt cotton-a remarkably high proportion in a fairly short period of five years. Of the 3.8 million hectares of hybrid Bt cotton grown in India in 2006, 34 percent was under irrigation and the 66 percent rainfed. A total of 62 Bt cotton hybrids were approved for planting in 2006 compared with 20 in 2005 and four in 2004. The major states growing Bt cotton in 2006, listed in order of hectarage, are Mashrashtra (1.840 million hectares representing almost half, 48 percent of all Bt cotton in India in 2006) followed by Andhra Pradesh (830,000 hectares or 22 percent), Gujarat (4,70,000 hectares or 12 percent), Madhya Pradesh (3,10,000 hectares or 8 percent), and 2,15,000 hectares (6 percent) in the northern zone and the balance in Karnataka and Tamil Nadu and other states. Events and Bt cotton hybrids The number of events as well as the number of Bt cotton hybrids and companies marketing approved hybrids increased from one event and 20 hybrids in 2005 to four events and 62 hybrids in 2006. This has provided a wider choice to the farmers in the different regions of the country. In 2006, a total of four events, of which three were new in 2006, were approved for incorporation in a total of 62 hybrids offered for sale. The first event known as Bollgard-I (BG-1), featuring the cry1Ac gene was developed by Maharashtra Hybrid Seed Company (Mahyco), sourced from Monsanto, and approved for sale for the sixth consecutive year in a total of 48 hybrids for use in the different regions (north, central and south) in the country. The second event, Bollgard-II (BG-II with event MON 15985) also developed by Mahyco and sourced by Monsanto, which featured the stacked genes cry1Ac and cry2Ab, was approved for sale for the first time in a total of seven hybrids for use in the central and south regions. The third event, known as Event 1 was developed by JK Seeds featuring the cry1 Ac gene, sourced from IIT Kharagpur, India and approved for sale for the first time in a total of four hybrids for use in the north, central and south regions. The fourth and the last event, the GFM event, was developed by Nath Seeds, sourced from China, featured the fused genes cry1Ab and cry1Ac and approved for sale for the first time in a total of three hybrids, one in each of the three regions of the country. Rolly Dureha with inputs from Ch. Srinivas Rao and Narayan Kulkarni New Page 1 The technology involved The core genetic engineering experiments, which culminated in the development of insect-pest resistant cotton (Bt cotton) were conducted by Monsanto, USA and comprised isolation of gene from Bacillus thuringiensis and its further development to ensure its expression in the fully-grown plant. The plasmid construct comprised: The cry1Ac gene, which encodes for an insecticidal protein, cry1 Ac. The 35 S promoter from cauliflower mosaic virus that drives expression of the cry1Ac gene in all parts of the plant leading to the production of the Bt protein. The nptII gene, the selectable marker, which encodes the enzyme neomycin phosphotransferase II (NPT II), is used to select transformed cells/plants on media containing the antibiotic kanamycin. The aad gene which encodes the bacterial selectable marker enzyme 3"(9)-O-aminoglycoside adenyltransferase (AAD) and allows selection of bacteria containing the cry1Ac plasmid on a medium containing the spectinomysin or streptomycin. Cotton tissue cultures (variety Cocker-312) were infected with the soil bacterium, Agrobacterium tumefaciens containing the plasmid with the above sequences. The transformed cotton lines were screened to identify those with desirable insect control and agronomic performance. Latest Bt cotton statistics According to the latest ISAAA findings, it is estimated that approximately 2.3 million small farmers planted on an average 1.65 hectares of Bt cotton in 2006. The number of farmers growing Bt cotton hybrids has increased from 3,00,000 small farmers in 2004 to one million in 2005, with over a two-fold increase in 2006, to 2.3 million farmers. Coincidental with the steep increased adoption of Bt cotton between 2002 and 2005, the average yield of cotton in India, which has one of the lowest yields in the world, increased from 308 kg per hectare in 2001-02 to 450 kg per hectare in 2005-06, with most of the increase in yield of up to 50 percent or more, attributed to Bt cotton. As per the minutes of the third meeting of the Cotton Advisory Board for the cotton year 2005-06 held in November 2006, at a national level, the introduction of Bt cotton has been a major factor in higher cotton production increasing from 15.8 million bales in 2001-02 to 24.4 million bales in 2005-06, which has been a record cotton crop for India. According to the paper "Economic impact of genetically modified cotton in India" published by Bennett et al in Agbioforum the principal gain from Bt cotton in India is the significant yield gains estimated at 45 percent in 2002 and 63 percent in 2001 for an average of 54 percent over the two years. Taking into account the decrease in application of insecticides for bollworm control, which translates into a saving of 2.5 sprays and the increased cost of Bt cotton seed, Brookes and Barfoot estimate that the net economic benefits for Bt cotton farmers in India were $139 per hectare in 2002, $324 per hectare in 2003, $171 per hectare in 2004 and $260 per hectare in 2005, for a four year average of approximately $225 per hectare. The benefits at the farmer level translated to a national gain of $339 million in 2005 and accumulatively $463 million for the period 2002 to 2005. Other studies report results in the same range, acknowledging that benefits will vary from year to year due to varying levels of bollworm infestations. The recent study in 2006 by V Gandhi and NV Namboodiri of IIM Ahmedabad on "The Adoption and economics of Bt cotton in India: Preliminary results from a study", report a yield gain of 31 percent, a significant reduction in the number of pesticide sprays by 39 percent and an 88 percent increase in profit or an increase of $250 per hectare for the 2004 cotton growing season. The Indian biotech cotton initiative The Nagpur-based Central Institute for Cotton Research (CICR) has been working on the development of Bt cotton varieties since the early 1990s. Now the institute is close to launching the sole Bt cotton variety in the country. The institute has been able to introduce the Cry1 Ac gene in an Indian cotton variety. The CICR Bt will be an independent variety, which the farmers will not have to buy every year from the market like the Bt hybrids available currently, as the primary transgenic is the original variety of the seed which can be preserved and used by the farmer in successive years. Hybrid seeds have to be bought anew every year. Elaborating further, Dr BM Khadi, director, CICR, said, "We have been working on this project for the last five to six years. The cotton system is a very tough to transform from a biotechnological point of view. Now we have been able to develop a special protocol for developing a transgenic Bt cotton variety. At present the variety will contain Cry1Ac gene. Cry 1Aa3 gene will also be introduced later. Both these genes are directed towards the bollworms." Currently the variety is under the RCGM trials. It is expected that it would take another one or two years to commercialize this variety, as the bio-safety and the all India level coordinated trials have to be yet conducted. CICR along with its test centers at the National Research Centre on Plant Biotechnology (NRCPB), Indian Council of Agricultural Reseach (ICAR) and the University of Agricultural Sciences (UAS) Dharwad have been working on this project and about Rs 6 crore has been spent on it. Cotton cultivation Approximately 65 percent of India's cotton is produced on dry land and 35 percent on irrigated lands. Hybrids occupy 70 percent (6.3 million hectares) of the cotton area and 30 percent (2.7 million hectares) are varieties. The percentage devoted to hybrids has increased significantly over the last few years, a trend that has been accentuated by the introduction of Bt cotton hybrids in 2002. Cotton is the major cash crop of India and accounts for 75 percent of the fiber used in the textile industry, which has 1,063 spinning mills and accounts for four percent of the GDP. Cotton impacts the lives of an estimated 60 million people in India, including farmers who cultivate the crop, and a legion of workers involved in the cotton industry from processing to trading. IMRB survey reveals high degree of farmer satisfaction with Bt cotton New Page 1 IMRB survey reveals high degree of farmer satisfaction with Bt cotton The IMRB survey on Bt cotton cultivation in India, one of the first of its kind aimed at understanding the awareness, perception and acceptability of Bt cottonseeds among cotton growing farmers in India, shows that low minimum support price and high input costs were some of the key reasons for the financial distress amongst farmers in the cotton growing regions of India. With respect to farmers' experience with Bt cotton,, the survey revealed that farmers using certified Bt cottonseeds showed significantly higher levels of satisfaction than farmers using non-hybrid as well as hybrid non-Bt seeds and that farmers' productivity expectations with certified Bt cotton were higher productivity expectations with non-Bt hybrid and non-hybrid seeds. The survey also revealed that a large percentage of farmers using certified Bt cottonseeds are likely to recommend Bt cotton as well as Bt fruits and vegetables to other farmers The study conducted in 23 districts across the five key cotton growing states of Maharashtra, Gujarat, Madhya Pradesh, Andhra Pradesh and the Tamil Nadu and Karnataka, revealed significantly higher levels of satisfaction amongst farmers using certified Bt cottonseeds as opposed to farmers using non-hybrid seeds as well as hybrid non-Bt seeds. Across all the five clusters, mean satisfaction levels of farmers using certified Bt cottonseeds were 4.36 (on a scale of 5) as opposed to scores of 4.14 and 3.96 recorded by farmers using ordinary cotton and hybrid non Bt cotton. Higher yields, good quality cotton production, higher pest resistance and higher return on investment were some of the key reasons for higher satisfaction levels with certified Bt cottonseeds.   ]]> <![CDATA["The government should allow GM crops after thorough analysis of the bio-safety and environmental safety issues"]]> https://biospectrumindia.com/news/95/4019/the-government-should-allow-gm-crops-after-thorough-analysis-of-the-bio-safety-and-environmental-safety-issues.html https://biospectrumindia.com/news/95/4019/the-government-should-allow-gm-crops-after-thorough-analysis-of-the-bio-safety-and-environmental-safety-issues.html Wed, 07 Mar 2007 13:33:00 +0530 New Page 1 "The government should allow GM crops after thorough analysis of the bio-safety and environmental safety issues" -PS Dravid, president, JK Agri Gentics Ltd Please tell us about your Btcotton seeds journey in India? We launched Bt cottonseeds during the 2006 kharif season with four hybrids in different zones, these being JKCH 1947Bt for the north zone, JK VarunBt for the central zone and JK DurgaBt and JKCH 99Bt for the south zone. We decided to enter the Bt cotton area during 1999-2000 by establishing a biotechnology research and development laboratory. We are primarily concentrating on crop improvement programs in various mandate crops. Biotechnology is being used as a tool (including GM crops) in this effort. Our focus is on developing transgenic crops, marker assisted selection and breeding, and DNA fingerprinting and analysis. Since genetically modified cotton was getting a lot of attention at that point of time and as also Bt cotton technology was being successfully cultivated in the US, we entered into the Bt cotton area to start with. What were some of the challenges that you faced while launching the Bt cotton seeds? We faced several challenges while launching Bt cotton seeds in India. Some of the challenges are : Technology sourcing was a difficult task as multinational companies were charging a very high price and trait value fee for access to their technology. Understanding the regulatory procedures and conduction of extensive trials to ensure bio-safety compliance of the event and to prove the superiority of products in different agro-climatic zones. High degree of coordination and follow-up were required in getting the clearances. Delay in the launch of the product resulted in substantial loss of the market share in non-Bt segment. We had to make fresh efforts to re-launch our seeds after getting the approvals. How has the sales of Bt cottonseeds been? During the 2006 kharif season, we sold around 2.5 lakh packets as we had received permission for seed production to the extent of only 100 hectares for each hybrid. We will be scaling up the sales volumes manifolds during 2007-08. Are you looking at other technologies? We have developed the technology in collaboration with IIT Kharagpur by giving sponsored research project to them for incorporating Cry 1Ac gene in our lines. At this stage, we are also looking at stacking a second gene obtained from NBRI, Lucknow, over the Cry 1Ac to have the product suitable for wider pest control. What are the initiatives you have taken to promote Bt cottonseeds? We conducted large-scale trials as per GEAC guidelines during the 2005 kharif season to study the performance of our hybrid field conditions. We took this opportunity to showcase our products to the farmers and gave them the know-how for cultivation of Bt cotton in their respective areas. What are the current promotional activities? Have farmers accepted Bt cotton? And what are the challenges now? We are focusing chiefly on educating farmers through field days and field visits. A large number of farmer meetings are conducted in the villages to create awareness. The X- gene brand will be further strengthened through various dealer conferences across the cotton-growing areas of the country. We will be utilizing various advertising media like the Press, TV channels, leaflets, posters for branding the X-gene further. We will be conducting technical trainings for our employees and the field staff to upgrade their technical skills. To a large extent, farmers have accepted Bt cotton technology and in a year or two they would also learn to harvest more and better kapas in different segments of cotton in various parts of the country. The challenges now appear to be in the change of cultivation practices where the farmer is required to have special focus on nutrient management of the crop from time-to-time. Since nutrient management becomes very difficult in rain-fed areas, it will be a major challenge to the farmers. The other challenges are managing drought, sucking pests and superior fiber quality. What are some of the measures that can be initiated to check the sale of spurious Bt cottonseeds? We have been requesting the government to give early clearances to alternate technology. This will bring about a healthy competition amongst the various players which would automatically put a check to the illegal sale of spurious cotton seeds in the market. The issue on price has brought most of the state governments under one umbrella to take on the corporate. Is this is a good move? It was a good step on the part of the state government to bring the companies together and ask them to bring down the prices. The reduction in price would definitely be an encouragement to the farmers to cultivate Bt cotton and put a check on the sale of illegal spurious cottonseeds. However, now that a large number of brands have come into the market, the government could allow the market forces to determine the price rather than regulating. Do you see a price war with more agri firms (with different technologies) entering the Bt cotton space? Owing to a very narrow time span window available for sale of cotton seed, price wars have become inevitable in the seed sector, more so because of un-differentiated products. Bt cotton can be an exception to the price. How do you see the future for Bt cottonseeds in India and other Bt food and feed crops? Bt cottonseed has come to stay. Acreage will steadily grow in the coming years. There could be a good scope for other genetically modified crops. If the government comes out with clear cut and transparent regulatory procedure for the approval of the food crops, more research could be taken up for the development of seeds carrying various Bt traits. Why has there been a mixed response to the success of Bt cotton in India? Bt cotton has received a mixed reaction primarily in the media. Looking to the large scale adoption that had taken place in Gujarat, Punjab and AP, there is no doubt about the success of Bt cotton in India. However, in some parts of the rain-fed areas in the country, Bt cotton was not successful as expected by the farmers, which was mainly due to other factors and had nothing to do with Bt cotton per se. Similarly, in the past few years, a lot of spurious and illegal seed has spread in major cotton growing tracts of the country. These could be the reasons for mixed reaction on Bt cottonseed in the media. What is the status of your R&D for the GM crops? We have a full-fledged biotechnology lab wherein we are working on several genes for various traits like biotic and abiotic strains. We would also be working on a number of other crops for developing salinity and drought tolerant hybrids. We are building up our R&D as well as marker assisted selection with novel traits with the help of biotechnology tools.   ]]> <![CDATA["Krishidhan is one of the first three companies to launch Bollgard-II"]]> https://biospectrumindia.com/news/95/2033/krishidhan-is-one-of-the-first-three-companies-to-launch-bollgard-ii.html https://biospectrumindia.com/news/95/2033/krishidhan-is-one-of-the-first-three-companies-to-launch-bollgard-ii.html Wed, 07 Mar 2007 13:27:00 +0530 New Page 1 "Krishidhan is one of the first three companies to launch Bollgard-II" Madhav Dhande, director-operations, Krishidhan Seeds Ltd Madhav Dhande has been associated with the agricultural sector for over three decades and is renowned for his analysis of operation planning and forecasting. He has been propelling Krishidhan's growth as a director- operations since the last five years. When did you launch Bt cottonseeds in India? And why and when did you enter the Bt cotton area? We launched Bt cotton in India during 2006. We decided to enter into GM crops in 2001 though the approval and regulatory procedure took a bit longer to launch the products. We entered the Bt cotton segment because of the continuous outbreak of bollworm complex, indiscriminate use of pesticides and drop in productivity, quality and profitability to a farmer. What were the challenges you faced during the launch of the Bt cottonseeds in India? Although we faced difficulty in conducting the trials on a very large number of farmers' fields as required by the regulatory process, the real bottleneck was when ICAR and SAU accepted only one genotype at a time. Delaying approvals to our other promising genotypes suited for different micro niches. What is your current reach and how has the sales been? During the first year of launch, we could sell Bt cotton only in the central zone and southern zone and we sold almost 1.5 lakh packets of Bt cotton. Based on the performance of our products in farmers' fields and enthusiasm, we anticipate a significant market share of 13-15 percent. Which technology do you use? Are you looking at other technologies? At present we are using Monsanto technology. Krishidhan is one of the first three companies to launch Bollgard-II, which is more effective than Bollgard-I and while we continue to use Monsanto technology, we are in the process of looking at other technologies that would let us control bollworms complex and other pests. We are also looking for virus, herbicide and drought resistant gene technology. What were the initiatives you took to promote Bt cottonseeds amongst the farming community across the country during the initial period of launch? Since the day one, i.e., before launch and during launch, we promoted Bt cotton technology as an "insurance" against Bollworm complex and introduced the concept of "Isase behtar kuch nahi". We highlighted the USP of BG-II as a "superior form of technology, superior protection, and maximum yield and profitability". We used this message to create awareness. In addition to this, we delivered and arranged more than 300 seminars on Bt cotton particularly in the central and south zones to educate farmers on a large scale. We also took initiatives in educating the farmers for Bt cultivation. Organizing such knowledge exchange programs has made Krishidhan's Bt cotton products as the most favorable and preferred choice of cotton for farmers in both the zones. What are the current promotional activities? Have farmers accepted Bt cotton? And what are the challenges now? The current set of promotional activities of Krishidhan is mainly focused on "BG-II technology with desired tolerance to sucking pest complex in our elite hybrid" and certainly the method of cultivation. Most of the farmers have happily accepted our Bt hybrids that promise good productivity and quality and our scientific teams and research center is continuously working towards further improvement and advancement of the available technology. Most of the big challenges faced by the industry in reaching Bt cotton to farmers in rural areas are partial control of different state governments on several issues like fixing realistic prices, packaging, and label claims, that too during the peak of the season. The other challenge is to deal with small players who respond to a cut-throat competition by resorting to illegal or sub-standard products. Is there a conflict of interest between the state governments and the seed companies? In our perception, it is not a fight between corporate and the state government where the primary aim of both the industry and the government is to protect the interest of the farmer. The industry's view is that if prices are made unprofitable, it will bounce back on farmers as he is involved in both seed and commercial production. If the industry fails to have organized seed production, the farmers will not get remunerative prices and lack of quality seeds will affect the income of farmers growing commercial crop. One has to understand that the higher prices of seeds are due to great value addition done by companies through the development of technology traits and improved germplasm. If companies do not get any incremental price for their superior germplasm, it will be a serious setback for R&D in private sectors. Hence, one expects government bodies to act with reason and restraint. How do you see the future for Bt cottonseeds in India and other Bt food and feed crops? The prospects of Bt cottonseed with value addition such as BG-II technology with herbicide resistance gene seem to be very promising. The prospect for Bt food also appears to be very good. We feel bringing insect resistance in other crops such as brinjal, redgram, cabbage, tomato and cauliflower will relatively decrease the amount of insecticides used which would lead to better human health and environment. With more companies entering the Bt cotton space, do you foresee a price war? Not really, more the merrier as the technology will be able to penetrate to all cotton farmers in different agri-eco zones. The company will win on quality but not on price, since the farmer has become discriminating and prefers to plant quality product even if the prices are higher. What are the reasons for the mixed reactions on the Bt cottonseeds in India? Though Bt cotton was launched about five years back, it has been surrounded by controversies. In a democratic country like India, nobody can be prevented from expressing their opinion. However, the reality is that Bt improves the environment and it has already reduced the pesticide consumption and also improved the income of farmers. The boogie of farmers' suicides or environmental detoriation due to Bt cotton looks more like a misinformation campaign. Which are the other GM crops areas that you contemplate to enter? We would like to extend our research on oil seeds, pulses and several vegetables. Our long-term goals are to reach out to poor farmers' needs and rain-fed conditions that includes maize, sorghum, bajra, pulses and many more. What is the status of your R&D for the GM crops? We have consciously decided to spend minimum 12 percent or more of our turnover in R&D covering both basic and applied research in agribiotech. We are in the process of establishing "state-of-the-art" biotechnology laboratories in Special Economic Zones (SEZs). Do you feel the government should allow more GM crops in India? Countries that have not compromised with the bio-safety but when convinced that a gene is bio-safe and have not hesitated in deregulating are the ones that have created maximum wealth in the agriculture sector.   ]]> <![CDATA["Bt cotton will continue to be in great demand"]]> https://biospectrumindia.com/news/95/7956/bt-cotton-will-continue-to-be-in-great-demand.html https://biospectrumindia.com/news/95/7956/bt-cotton-will-continue-to-be-in-great-demand.html Wed, 07 Mar 2007 13:13:00 +0530 New Page 1 "Bt cotton will continue to be in great demand" - M Ramasami, MD, Rasi Seeds When did you launch Bt cottonseeds in India? And why and when did you enter the Bt cotton area? We launched Bt cottonseeds in India in 2004. RCH 2 Bt is our first Bt cotton hybrid. I decided to enter the area of transgenic Bt cotton during 1997 after I realized that it is beneficial to the Indian farmers in view of reduced pesticide use and ensured yield by way of good protection from cotton bollworm attack. I was confident that environmental pollution could be substantially reduced since cotton is a crop that consumes maximum percentage of pesticides used for agricultural crops.   What were the challenges you faced during the launch of the Bt cottonseeds in India? And under which brand name (product name) do you market Bt cottonseeds in India? When it was first introduced, there were mixed feelings among the farmers, as the technology is new to India. Further, there were many apprehensions. We had to do a lot of field demonstrations in all the cotton-growing regions of India to instill confidence among the farmers on the benefits of this wonderful technology. Our first Bt cotton hybrid was RCH 2 Bt. Currently we have 14 Bt cotton hybrids approved by the Government of India for commercial cultivation.   What is your current reach and how has the sales been? We have reached 30 percent share on the total sale of Bt cotton during 2006 and our sale is 27 lakh packets of 450 grams each.   Which technology do you use? Are you looking at other technologies? We have been using the Bollgard technology developed by Monsanto. Currently I'm taking the initiative to outsource technologies, especially for drought, improving fertilizer use efficiency for viruses like yellow vein mosaic in bhendi, leaf curl virus in cotton and tomato etc. from promising technology providers around the world.   What were the initiatives you took to promote Bt cottonseeds among the farming community across the country during the initial period of launch? To promote the efficacy and usefulness of Bt technology for cotton, during the initial period, we conducted the following: 450 field demonstrations during 2003 in six states 640 trials in 2004 in nine states 740 field visit programs for farmers (2002-03) 6000 in-field training programs with 2.7 lakhs farmers during 2004 866 field visit programs for farmers with Bt and non-Bt hybrids 92,700 farmers visited the fields of Bt cotton hybrids In addition, to popularize the benefits we did the following: Press advertisement Contacts with scientists/government officials/ NGOs/media Demonstration boards in all demo sites Pest boards â€“ to create awareness on the different pests that attack cotton crop Hand bills â€“ with details of the product and its package of practices (in the vernacular language) Cards showing the cotton cultivation practices Pocket cards were given on the salient launch of the program Training on the right use of this technology Press/TV coverage of these events and media van campaign. What are the current promotional activities? Have farmers accepted Bt cotton? And what are the challenges now? We continue to work with the farmers in addition to distribution and supply of Bt cotton hybrid seeds. Our dedicated staffers visit farmers across India right from Tamil Nadu to Punjab and advice the farmers regarding the maintenance of the cotton crop and thus benefit them to the fullest. The farmers are convinced about the benefits of Bt cotton technology and are willing to grow Bt cotton continuously. Now the challenge to us is to prove how Rasi cotton hybrids with Bt technology is superior. We had to create better high-yielding germplasm continuously to keep the superiority and maximum coverage of Rasi Bt hybrids.   What are the measures taken by your company regarding the availability of legal seeds and to put a check on illegal sale of spurious Bt cottonseeds in the market? We are continuously creating communication to farmers about the benefits of Bt technology under superior germplasm background. We strongly believe that the menace of illegal seeds can be contained only by: Instilling confidence on the quality of seed and adequate supply at reasonable price; And making the farmers to realize that only legal seed suppliers are accountable and reliable.   The issue of pricing has brought most of the state governments under one umbrella to take on the corporate. What are your views on the same? The state governments are concerned about the distress of farmers. The perception on cost of seed as the main cause for farmers' distress is superficial. The state governments have realized that the distress of the farmers should be addressed quickly. Joining together and restricting the prices to the extent of damaging the health of the seed industry is the problem. The seed industry in India is comparatively of very recent origin. Except a few companies, most seed companies are small players. They do not have the strength to face heavy odds. The implementation of various laws on seed regulation is in the hands of state governments. All the biotechnology inventions have to be carried through seed only. The seed companies have to invest very heavily on R&D, create good infrastructure, hire a lot of technical manpower. Once this happens, the future of agriculture will be stable. There should not be any interference in the pricing decision. The market forces should be allowed to work. Only then better competition will prevail leading to better products for the benefit of farmers. The current trends definitely block the development of the seed industry and stymie flow of newer technologies continuously.   How do you see the future for Bt cottonseeds in India and other Bt food and feed crops? Bt cotton will continue to be in great demand in view of the substantial benefits realized by the farmers. The efforts on increasing food production by conventional breeding has reached a plateau and to meet the growing demand for food, production efforts has to go up. The quick possible way is to reduce the loss due to insect pests. I am confident Bt food crops will help us to meet this challenge. I have no idea on the feed crops.   Do you see price war in this space with more agri firms (with different technologies) entering the Bt cotton space? Prices are decided by the value the consumer gets out of the technology. Better technology, germplasm and high net return will always fetch higher price.   What are the reasons for the mixed reactions on the Bt cottonseeds in the last five years in India? Lack of understanding about the role of technology, high expectation on the farmers' side. Initial hybrids with good technology and poor germplasm has created mixed reactions. Now perfect understanding prevails on the benefits of technology and germplasm. The farmers' expectation has become very reasonable. The increased coverage of Bt cotton in India and huge demand for future sowings clearly shows that there are no mixed feelings now.   According to you, how many farmers who used Bt cottonseeds might have taken the extreme step of committing suicide in the last five years in different parts of the country? There cannot be any suicide death because of Bt cottonseeds. Bt cotton crop had always given the better benefit to the farmer than the non-Bt cotton crop. Bt cotton can never be a cause for suicide. People should understand the Bt technology has got a limited role on protecting the crop from the damage of bollworms. Suicide by farmers may be due to several socio-economic problems.   Which are the other GM crops areas that you contemplate to enter? We would be interested in insect resistant rice, brinjal, tomato, bhendi, virus resistant bhendi, tomato and cassava.   What is the status of your R&D facility for GM crops? Work is in progress to create the facility, sourcing technology, recruiting technical manpower.   Do you feel the government should allow more GM crops in India? Yes. This is in view of the substantial benefit to the farmers and consumers.   ]]> <![CDATA["India has a unique opportunity to exert global leadership by facilitating the timely approval and deployment of biotech fiber, feed, food and fuel crops."]]> https://biospectrumindia.com/news/95/6872/india-has-a-unique-opportunity-to-exert-global-leadership-by-facilitating-the-timely-approval-and-deployment-of-biotech-fiber-feed-food-and-fuel-crops-.html https://biospectrumindia.com/news/95/6872/india-has-a-unique-opportunity-to-exert-global-leadership-by-facilitating-the-timely-approval-and-deployment-of-biotech-fiber-feed-food-and-fuel-crops-.html Wed, 07 Mar 2007 13:05:00 +0530 New Page 1 "India has a unique opportunity to exert global leadership by facilitating the timely approval and deployment of biotech fiber, feed, food and fuel crops." -Dr Clive James Dr Clive James, an internationally renowned agricultural scientist founded ISAAA in 1990, which facilitates the acquisition and transfer of agricultural biotechnology applications from the industrial countries, for the benefit of resource poor farmers in the developing countries. On the occasion of the 5th anniversary of Bt cotton in India, he shares his thoughts on the way forward for India. India has the maximum acreage of Bt cotton in Asia (3.8 million hectares compared to China's 3.5 million) as per the latest ISAAA findings for 2006. What is the way forward for India now? Biotech crops offer India substantial benefits in the near term and provide the opportunity for the country to strengthen its world leadership in the adoption of biotech crops. This will ensure its competitive advantage globally in terms of crop production and coincidentally biotech crops can contribute to economic growth, a better environment and more importantly to the alleviation of poverty and hunger. The way forward for India is first to significantly increase its area of Bt cotton in the next few years so that the gains can be shared with even more Indian cotton farmers, cotton textile workers and consumers. Cotton impacts the lives of 60 million people in India and is a major export for the country. Future gains from Bt cotton can be substantially greater than those achieved in 2006, as more Indian farmers adopt the superior Bt cotton technology. The most recent public sector study on Bt cotton by Dr Gandhi et al confirms an average yield gain of 31 percent, a significant reduction of 39 percent in the number of pesticide sprays and an 88 percent increase in profit, equivalent to $250 per hectare for the 2004 growing season. Prior to the introduction of Bt cotton in India in 2002, Indian cotton yields were one of the lowest in the world. However, after the introduction of Bt in 2002 cotton yields increased from 308 kg per hectare in 2001-2002 to 450 kg per hectare in 2005-2006, a 46 percent increase in yield, with most of the increase attributed to Bt cotton. In turn, exports of raw cotton from India soared from 0.9 million bales in 2005 to 4.7 million bales in 2006, the highest ever. The number of companies in India selling Bt cotton increased from one in 2002 to 15 in 2006, giving farmers a broad choice of Bt cotton products to choose from. Bt cotton developed by the public sector in India is at an advanced stage of development and will give the farmer more choices of Bt cotton hybrids to select-those developed by either the public sector or the private sector. About 15 biotech crops are under development by both the public and private sector including mustard hybrids and nutritionally enhanced potatoes, which are at an advanced stage of development. Leading traits in new biotech crops include pest and disease resistance as well as delayed ripening in fruit and vegetables. Further, the development of golden rice as a contribution to remedy Vitamin A deficiency and longer-term programs with focus on salinity and drought resistance in rice, the most important food crop in India and more importantly the principal food crop of the poor, holds much promise. An advanced collaborative program between the private and public sector program features the development of both hybrid and open-pollinated Bt Brinjal (eggplant) resistant to fruit and shoot borer, which sometimes requires insecticides every other day. Brinjal is a very important vegetable crop that is grown on 5,00,000 hectares in India and supplies 25 percent of the calorie needs of resource-poor farmers, who cultivate on average 0.26 hectares of eggplant, which is also a major cash crop. Bt brinjal is expected to double yields, reduce pesticides by half, and deliver an increased income to small farmers equivalent to over $400 million per year at the national level and this will be a substantial contribution to the alleviation of their poverty. In summary, India has a unique opportunity at this time to exert leadership at the global level by facilitating the timely approval and deployment of a chronology of biotech fiber, feed, food and fuel crops that can coincidentally ensure that crop production in India is competitive in an increasingly globalized world; contribute to economic growth; a safer environment and contribute to food, feed, fiber and fuel; and most important contribute to the alleviation of poverty and hunger for its people. In spite of the significant success of Bt cotton, there are some who believe that this technology poses a risk to India. Based on the consistent body of evidence accumulated in India and 21 other countries by about 45 million farmers over an 11-year period, the evidence is clear that this technology offers substantial benefits to India. On the contrary, the greatest risk associated with this technology for India is not to use it. According to the ISAAA 2006 report, the global transgenic crop cultivation breached the 100 million hectare mark in 2006. However, there is reluctance in the acceptance of GM technology by the masses globally. Why is it so? One of our characteristics as people is that we do not handle change very well, and we are usually more comfortable with the status quo, which may be the least safe situation, but we are creatures of habit and resist change. Witness the resistance to pasteurized milk and irradiation of food when first introduced-in both cases it took time for society to change its view and embrace the new technologies, which offered significant advantages over the conventional technology being applied at that time. Biotech crops are no different and hence the sharing of knowledge to inform society about the new science is a top priority. A better-informed society will be able to engage in a transparent knowledge-based decision-making process, which will allow a more objective evaluation of the attributes of biotech crops and their potential contribution to society. Surveys confirm that the more knowledgeable society is about biotech crops the more acceptable biotech crops are to society. Recent surveys in the US, where 300 million people have consumed biotech food for more than 10 years without a single incident related to food safety, report that biotech crops were not even on the list of concerns about food, whereas concerns such as pesticide residues and allergies were significant issues to many people. In fact, survey results indicate that people would preferentially select biotech products if they contained omega 3 oils because of the substantial nutritional and health benefits they offer. Omega 3 biotech products are expected to be in the market in about five years, subject to timely regulatory approval. It is very important to recognize that 3.6 billion people living in 22 countries that planted officially approved biotech crops-which is more than half the world's population of 6.5 billion-consumed GM crop produce as food, feed and fiber in 2006. These crops generated significant benefits in terms of improved production, significant economic environmental as well as socioeconomic benefits; in developing countries biotech crops have contributed to the alleviation of poverty and hunger. The planting of 102 million hectares by over 10 million farmers in 2006 is clear evidence of the high level of acceptance of biotech crops and their products globally. Furthermore, another 29 countries have approved biotech crops for import for food/feed bringing the total number of countries that have already approved biotech crops to 51 countries representing 70 percent of the global population. This represents a high level of acceptance which has increased every single year for the last 11 years and is expected to continue to increase in the future, as more countries approve and adopt biotech crops. It is clear that the technology is here to stay. In fact, it has increased at an unprecedented rate by double digit growth every single year for the last 11 years, making it the fastest adopted crop technology in recent history. It is a vote of confidence of farmers who have made approximately 45 million independent decisions to increase their plantings of biotech crop every single year since commercialization began in 1996, a remarkable acceptance record, by any standard. Many GM products are mired in regulatory issues. How can the regulatory process be made simpler without compromising on the safety aspect? How feasible is it to evolve global regulatory guidelines along with global awareness programs? The complexity of the regulatory environment for biotech or GM crops results from two aspects of over-regulation-the data needs for applications and the long delays and unnecessary repetitiveness of regulatory review. Data requirements: The original data requirements for the general release are derived from "points to consider" produced between 1986 and 1992 in a technical working group of the Organisation for Economic Co-operation and Development (OECD). These data needs were further refined in national regulations around the world. The OECD guidelines deliberately took a comprehensive view of the matter, meaning that many questions are repetitive and unnecessarily detailed. A major precedent set in these guidelines was that the unit of regulatory review is the event, i.e., the specific combination of a particular new gene insert in a particular place in the plant genome. As a consequence, every new genetically modified line resulting from introducing the same gene into a plant has to be reviewed and treated as a completely new product. For example, there are several Bt maize events on the market, using the same or almost identical new gene, and all of these have had to produce a completely new biosafety assessment and regulatory application file. Experience, with these multiple events, shows that there is no good reason to maintain this overcomplicated requirement. A review to agree that the unit of regulation should be the phenotype and the gene inserted, not the event, would greatly reduce the amount of data needed without compromising safety in any way. Another major source of complexity and resource waste is the lack of MAD (mutual acceptance of data). There is a totally unnecessary requirement by many national bodies to reproduce data on safety through institutions in their own country. It ignores the fact that much greater national benefits can be drawn from the expeditious deployment of the biotech or GM crops to the farmers. Regulatory delays: Once a comprehensive biosafety file has been developed, and regulatory applications have been filed, the initiative moves from the applicant to the regulatory bodies. Regulations worldwide have legally agreed time limits for review and decision-making. While applicants are held to these, authorities almost without exception disregard these time limits, making it impossible for the applicants to make informed plans for the next steps in their activities. This is counter-productive in two ways. First, it delays applications unreasonably. This time loss represents a loss of benefits for farmers who are supposed to benefit from the products and also a loss of income for the applicant, including interests on capital invested. For public institutions, there is another damaging result: unreasonable delays of the regulators often result in public projects running out of funding, leading to many promising projects being abandoned simply because they run out of money. The current initiative in India to explore the streamlining of the evaluation process of biotech crops is welcome and could significantly benefit developers of biotech crops, farmers and consumers in India by eliminating the opportunity cost associated with regulatory delays. The Union Minister of Agriculture has encouraged the streamlining of the process for the same reasons cited above. Rolly Dureha   ]]> <![CDATA[Regulatory regime for GM products in India]]> https://biospectrumindia.com/news/95/2025/regulatory-regime-for-gm-products-in-india.html https://biospectrumindia.com/news/95/2025/regulatory-regime-for-gm-products-in-india.html Wed, 07 Mar 2007 13:00:00 +0530 New Page 1 Regulatory regime for GM products in India RK Sinha, Executive Director, All India Crop Biotechnology Association The regulatory systems developed indigenously have worked successfully till date, and have not been faulted so far by any credible scientific community The first green revolution saved us from the precarious situation of 'ship to mouth existence'. We attained self sufficiency in foodgrain production. The situation, however, is changing dramatically. From 170 million hectares of arable land, the availability may well be around 100 million ha by 2020 in view of the need for the increasing population as well as for greater afforestation and environmental preservation activities. The number of farmers available for agriculture will also reduce to less than 50 percent. Thus, in the backdrop of a declining per capita availability of arable land due to ever rising population, very low productivity levels, heavy losses due to biotic (pests, pathogens and weeds) and abiotic (drought and salinity) stresses, high storage and transportation losses, and large scale nutrient deficiencies in undernourished children and expectant mothers, we have to look around for measures to increase productivity in agricultural sector through research and newer production technologies. We have to produce more from less. Therefore, we, as a nation, must adopt appropriate technologies in Indian agriculture. And, in the matter of selection of appropriate technologies, we must go in for the technologies that enable us to achieve what we want without in any way harming the environment, the health of human beings and animals. It is in this context that agricultural biotechnology becomes very relevant. It is an important weapon for crop yield improvement, reduction in chemicals and pesticides usage, improving food and storage quality, in providing effective resistance to pests and pathogens, and has the potential for tolerance to drought and saline conditions. In effect, it is the panacea for the various adverse agricultural conditions present in India. There are, however, certain risks associated with this technology, as with any new technology. These risks, when handled in a cautious and scientific manner, can be either eliminated or minimized to levels that are not harmful. Hence the need for a regulatory regime. It is a tribute to the sagacity and wisdom of the government and its scientists that, much before the first testing for the GM products could be thought of, they put in position a regulatory mechanism by promulgating a set of rules governing hazardous Microorganisms/Genetically Engineered Organisms or Cells in 1989 (Rules 1989) under the EPA. In 1990, the Department of Biotechnology (DBT) came out with a set of guidelines as required under the Rules 1989. These were revised in 1994 and 1998. The 1998 guidelines on transgenic crops, provides a set of toxicity and allergenicity parameters for evaluation of safety of the transgenic seeds, vegetables, leaves etc for the health of human beings and animals. Some toxicity protocols were also added, which include, feeding studies on lactating cows, fish and chicken. The protocols provided in the guidelines, would comprehensively indicate whether the transgenic product have any toxic potential for human and animal health. The 1998 guidelines also added genetic data on comparative economic advantage of a modified plant. It thus made the regulatory framework not only environmentally safe but economically viable also. These guidelines are based on current scientific information and on experience gained in different countries across the world. The stringent regulatory systems put in place are science based and transparent. The guidelines cover all eventualities and the entire spectrum of activities including deliberate and unintended/accidental release into the environment of organisms, plants, animals and products derived from rDNA techniques. There are strict protocols for risk assessment and risk management in the event of a crisis. The two main principles involved in ensuring environment safety, 'the polluter must pay' and 'precautionary principle', are embedded in these guidelines and protocols. As a measure of abundant caution, even though a crop is commercially approved in another country, it must go through the rigorous trials and testing in India as per the established protocols before it is introduced into the environment. The impact of GMOs on the environment, soil, plant, animal and human life, have all been studied and will be studied in future in case of other events as per the existing protocols, before approving the introduction of a particular event into the environment. The systems developed indigenously have worked successfully till date, and have not been faulted so far by any credible scientific community. This is certainly a matter of utmost satisfaction for the Indian scientific community. The apex regulators for transgenics, GEAC and DBT, have also evolved with the rich experience that they have gained over the years. They are now more mature and confident of the subject matter, despite its uncertainties. Before any decision is taken, a rigorous cost-benefit analysis is always done to ensure that the decisions are in the overall interests of the Indian farmers, without harming the ecology and the health of human beings and animals. Various international agencies have also come out in favour of GM food/crop. OECD has said that the risks associated with biotechnology derived foods are not inherently different from the risks associated with conventional ones. WHO has echoed a similar sentiment by saying that it is not aware of scientifically documented cases in which the consumption of these foods has had negative human health effects. ENTRANSFOOD, a network of international experts, the Royal Society of London, and many other prestigious organizations have also made similar statements. The implementation of the regulations involves a number of players. These include the seed companies, the farmers on whose fields the trials are conducted, the Institutional Biosafety and the Monitoring and Evaluation Committees. The seed companies are rigorously implementing the protocols prescribed by the regulators, and have also built up in-house capabilities to tackle any emergency. Till date, there has not been any let up in their responsible use of the technology. Despite what the critics and activists have to say about the acceptance of this technology, the rigorous scientific protocols and studies conducted in India have amply demonstrated that GM products are safe for the environment, human beings and animals. The farmers have also given a thumbs-up to it, by itself enough to discredit the activists and critics. It is thus evident that the concerns that have been raised about potential risks to both food and environment safety in the case of transgenic crops using recombinant DNA techniques have not found favor with the other stakeholders, particularly the farmers, mainly due to the robust regulatory regime in place.     ]]> <![CDATA[Safety aspects and benefits of Bt cotton]]> https://biospectrumindia.com/news/95/7190/safety-aspects-and-benefits-of-bt-cotton.html https://biospectrumindia.com/news/95/7190/safety-aspects-and-benefits-of-bt-cotton.html Wed, 07 Mar 2007 12:53:00 +0530 New Page 1 Safety aspects and benefits of Bt cotton Dr TM Manjunath, Former director, Monsanto Research Center. Bt being a new technology, several technical aspects are not clear to many. This article makes an attempt to provide scientific information on Bt and Bt cotton. Bt cotton, developed by Mahyco-Monsanto, is the first agribiotech product approved by the Genetic Engineering Approval Committee of Govt of India in March 2002 for commercial cultivation in India. This approval was preceded by comprehensive biosafety studies and more than 500 field trials were carried out for six-seven years as per the direction of the regulatory authorities to demonstrate its safety and benefits. Even so, those who are opposed to this technology have raised several issues regarding its safety, creating doubts and confusion in the minds of farmers and the general public alike. Also, being a new technology, several technical aspects are not clear to many stake holders. What is Bt ? Bt is the popular abbreviation for Bacillus thuringiensis, a bacterium commonly found in soil with ubiquitous distribution. Its insecticidal property was discovered in Japan way back in 1901. More than 90 varieties or sub-species of B. thuringiensis have been described so far. A unique feature of Bt is that each variety possesses a distinct gene encoding an insecticidal protein that can affect only a narrow range of insects belonging to a particular group. Thus, there are Bt proteins that can affect certain larvae of only Lepidoptera (moths and butterflies), Coleoptera (beetles), Hemiptera (bugs), Diptera (flies) and so on. A particular Bt protein active on one group of insects generally does not affect other insects or other organisms. What are Bt crops? Depending upon the type of pests to be controlled, the relevant Bt gene is isolated, studied, modified to be more like a plant gene and introduced into the desired plant by genetic engineering. Such a gene becomes stably integrated in the plant genome and becomes an inheritable trait. The technology is made available to the farmers in the seeds itself and therefore no special skills are required to adopt it. Such transgenic crops containing the Bt genes are called Bt crops. How does Bt act? Bt-proteins require certain specific conditions for them to be active against the insect. In the first place, the Bt protein has to be ingested by the susceptible insects as it has no contact effects. In the case of Bt cotton, this happens when the larvae feed on plant tissues. The protein requires an alkaline gut with a suitable pH (9.5 and above) for its activation. There should be specific receptors in the insect mid-gut epithelial cells for protein-binding before it can kill the insect. All these conditions are available only in the susceptible insects and therefore they succumb when they feed on Bt plants. The mortality of bollworms that feed on Bt cotton is one such example. How are bollworms affected by Bt cotton? In the commercialized transgenic Bt cotton plants, the expression of Bt protein is constitutive i.e., the protein is expressed in all parts of the plant. When the newly hatched bollworm larvae feed on any part of the Bt cotton plant like leaves, squares, green bolls etc, they ingest Bt protein along with the plant tissues. As the bollworms are susceptible, the Bt protein gets activated in the mid-gut and the activated molecules bind themselves to certain receptors present on the gut membrane, very much like a specific key fitting into a lock. Such a specific interaction between the activated Bt protein and receptor results in 'pores' being formed in the insect intestine, causing destruction of the gut lining. The haemolymph (insect blood) carrying the ions and vital nutrients leak into the intestine. This leads to paralysis of the insect gut as a result the insect stops feeding. This sequence of events can take place within a few hours. The affected larvae may die after a day or two, but since it stops feeding, any further damage to plants is prevented (see figure). All the major cotton bollworms in India like the False American bollworm (Helicoverpa armigera), pink bollworm (Pectinophora gossypiella), spotted bollworm (Earias vittella) and spiny bollworm (Earias insulana) are susceptible in their early larval stages (first and second instars) to Bt proteins that are expressed within the Bt cotton plants. In other words, they possess all the specific conditions required for the activation and effectiveness of Bt protein and therefore they succumb. Thus, Bt cotton is helpful in controlling cotton bollworms. How safe is Bt cotton to non-target organisms? Comprehensive biosafety studies, as stipulated by the regulatory authorities, were carried out in India to ascertain the safety of Bt protein to animals and other non-target beneficial organisms. Feed-safety studies using the Bt cotton seed-meal were conducted on goats, buffaloes, cows, rabbits, birds and fish by competent scientists at various institutions like the Industrial Toxicological Research Centre, Lucknow; National Dairy Research Institute, Karnal; Central Institute of Fisheries Education, Mumbai; Central Avian Research Institute, Izatnagar; National Institute of Nutrition, Hyderabad; and GB Pant University of Agriculture and Technology, Pantnagar. The results revealed that the animals fed with unusually high dose of Bt protein via the seed-meal showed no ill-effects and were comparable to control animals in the various tests. In other words, Bt cotton seed-meal was substantially equivalent to its non-Bt counterpart. Based on such scientific data, the regulatory authorities have approved Bt cotton as safe. Does Bt cotton contain the 'terminator technology?' It was alleged by the activists of a few NGOs that Bt contains the so-called 'terminator gene' and that this gene would escape and cause 'gene pollution' and sterility in the surrounding plants. Monsanto reiterated that their Bt cotton does not contain the so-called 'terminator gene' but the activists went ahead and burnt a few RCGM-approved Bt cotton trial fields as a mark of protest. Following such incidences, the Department of Genetics, University of Delhi (South Campus), Delhi, on the advise of the regulatory authorities, carried out molecular detection tests on Mahyco's Bt cotton hybrids and found that there was absolutely no trace of any 'terminator gene' in them. These hybrids tested positive only for the Bt gene. Another 'common sense' test was carried out by a progressive farmer in Haveri and also by the University of Agricultural Sciences, Dharwad, Karnataka. They sowed the Bt cotton seeds of the F1 generation and demonstrated that these germinated like normal seeds. If it had terminator gene, the seeds would not have germinated as such. These experiments conclusively demonstrated the absence of 'terminator gene' in Bt cotton. Can bollworms develop resistance to Bt cotton? Pest resistance is a concern with any control measure and not peculiar to Bt cotton alone. In view of this, insect resistance management (IRM) strategies have been developed and are in place so as to prevent or delay the possible development of bollworm resistance to Bt cotton. These include the following: Insect Resistance Management (IRM) strategies Refuge crop: Planting non-Bt cotton as border rows to Bt cotton is currently recommended as one of the key elements of IRM. It is called 'refuge.' This is practiced in other countries like the US and Australia and has also been recommended by the GEAC in India. The 'refuge' crop could be 20 percent of the Bt cotton area with the intervention of plant protection measures when required or five percent of the area without providing any chemical protection. The refuge strategy is designed to ensure the availability of the Bt-susceptible pest population so as to mate with the Bt-resistant population, should they arise. It is expected that a great majority of bollworm larvae that feed on 'refuge' (i.e., non-Bt) crop, in the absence of adequate control measure, would complete their development and emerge as moths. These remain as susceptible strain (SS) and their number is generally large. On the other hand, almost the entire population of newly hatched larvae that feed on Bt plants would perish with only a very few developing into moths. These are the moths carrying the resistance gene (RS). Because of the overwhelming population of the susceptible (SS) moths in the vicinity, coming from the refuge crop, and a very scant population of the resistant (RS) moths, the possibility of SS mating with RS is far greater than RS with RS. Resistance in this case being recessive, the pairing of SS and RS would result in a susceptible progeny. Thus, the refuge helps in maintaining susceptible population which would succumb to Bt-protein when they feed on Bt cotton. Theoretically the refuge does not have to be cotton but could be any plant that supports Bt-susceptible bollworms. Studies have revealed that in India, a pest like Helicoverpa armigera has a large number of alternative host crops like pigeonpea, chickpea, tomato, sunflower, capsicum etc. These would further help in IRM and have the potential to replace structured 'Bt cotton' refuge. Other IRM strategies Besides 'refuge', several other IRM strategies have also been developed and practiced. These include the 'optimum dose' strategy wherein the plant is empowered to express Bt protein at a much higher dosage (>25 times) than normally required for larval mortality. The objective is to bring about maximum mortality of pest larvae, giving minimum chance for the potential resistant larvae to survive. Another IRM strategy is 'gene stacking' or 'gene pyramiding.' In this approach, more than one gene, each having a different mode of action and binding to a different receptor in the insect gut, is incorporated into the same plant against the same pests. The idea is that even if the pest develops resistance to one gene, it would succumb to the other as the possibility of it developing resistance to both the genes simultaneously is very remote. In the last five years of its large scale cultivation in India and for eleven continuous years in several other countries on millions of hectares, there is no indication that any of the bollworm species has developed field resistance to Bt cotton anywhere in the world. This shows that it is not easy for the pests to develop resistance to Bt protein expressed in planta and also that the present IRM strategies are working well. Nevertheless, resistance is a genuine concern and we should continue to be watchful. Bt cotton is safe Bt cotton is a thoroughly researched biotech product that has undergone all the tests pertaining to bio-safety and agronomic performances as prescribed by the concerned regulatory authorities in each country including India. Its safety to non-target organisms including animals and humans as also to environment has been demonstrated through comprehensive scientific studies. During all these years of its continuous cultivation on million of hectares, there is no proven scientific evidence that Bt cotton has caused any negative impact related bio-safety, cross pollination or pest resistance anywhere in the world. The major benefits from Bt cotton include effective control of bollworms leading to significant yield increase, drastic reduction in chemical sprays and substantial increase in net profit to farmers. Efforts should be made to sustain these social, economic and environmental benefits.   ]]> <![CDATA[Cotton economics in India is confused]]> https://biospectrumindia.com/news/95/6092/cotton-economics-in-india-is-confused.html https://biospectrumindia.com/news/95/6092/cotton-economics-in-india-is-confused.html Wed, 07 Mar 2007 12:46:00 +0530 New Page 1 Cotton economics in India is confused Dr Suman Sahai Convenor, Gene Campaign, New Delhi E-mail: genecamp@vsnl.com Website: www.genecampaign.org The Bt cotton example should teach us that the social, economic and political impact of this technology needs to be understood in order to better identify the path of technology adoption that developing countries should follow when expensive transgenic technologies are on offer. Bt cotton is so far the only genetically engineered crop to be given permission for commercial cultivation. It has been cultivated in India since the agriculture season of 2002- 2003 when three Bt cotton varieties owned by the company Mahyco-Monsanto Biotechnology were given approval for commercial cultivation. The three Mahyco-Monsanto Biotechnology (MMB) varieties, MECH 12, MECH 162 and MECH 184 were given provisional permission for three years for cultivation in six states, Andhra Pradesh, Tamil Nadu, Maharashtra, Gujarat, Madhya Pradesh and Karnataka. Of these, some are irrigated and others like Andhra Pradesh and Maharashtra are dry land areas. However, before the approval for the MMB varieties, for a period of at least three agriculture seasons, Navbharat Seed Company in Gujarat, had already sold Bt cotton seeds to farmers in the state. This Bt cotton did not go through the biosafety regulatory system and is therefore illegal, but it is a strong player in Bt cotton cultivation in the country. The regulatory system has failed to control the spread of illegal cotton nor taken a policy decision on it. Although a case has been filed against Navbharat, it is dragging in the courts, plagued with serious procedural lapses on the part of the government. No action has been taken yet, seven years after the illegal cotton was detected. The performance of the MMB varieties has been controversial, there being reports of failure of the cotton in many parts of the country, chiefly in the dry land states of Andhra Pradesh and Maharashtra. Data on Bt cotton performance has been collected by a number of agencies, which has included state agriculture departments, civil society organizations, academic institutions and media persons. The consensus appears to be that the MMB cotton has largely failed. The provisional permission granted to MMB in 2002 has not been renewed. Other Bt cotton varieties have done poorly in the dry land areas and better in the irrigated zones. There is no authoritative assessment of the performance of Bt cotton in India despite all the controversy surrounding it, yet the GEAC continues to approve Bt cotton varieties without pause and without review. Bt cotton technology adoption has been inconsistent in India and most farmers have not maintained the mandated insect management refuges needed to keep the technology effective. Pesticide sprayings have continued partly because of lack of awareness and partly because pest attacks have been heavy and have required large numbers of pesticide sprays, leading to insignificant savings on pesticide use, the main claim of the Bt technology package. In addition to this, Bt cotton was found to require far more water than its non-Bt counterpart. Bt cotton seeds are expensive, priced at approximately four times the cost of high performance non Bt cotton hybrids. This raises input costs for the farmers and if yield and pesticide savings are not substantial, the farmer gets into an unprofitable situation. Currently 62 varieties of Bt cotton have been approved for commercial cultivation. These are approved for the six original states as well as the new states of Punjab, Haryana and Rajasthan, which are the states in northern India, where cotton cultivation is in irrigated lands. As of today, Bt cotton varieties have been approved for all the cotton growing regions in India. The new Bt cotton varieties are from Indian seed companies but almost all incorporate the Cry 1Ac gene licensed from Monsanto. Only Nath Seeds has incorporated a Bt gene developed by the Chinese. No public sector institution has yet brought a Bt cotton variety to the market although several have been conducting research these past several years. Legal dispute over Bt cotton The controversy over the performance of the Mahyco Monsanto Bt cotton has escalated into a legal dispute with the company being charged with exorbitant pricing and establishing monopolies in the field of Bt cotton. Mahyco Monsanto had priced its Bt cotton at Rs 1,650 per bag of seeds, which they later raised to Rs 1,800 per bag. Of the Rs 1,650, Rs 1,250 went to Monsanto as license fee for use of the Bt technology. The license fee was increased when the price was hiked to Rs 1,800. This is the highest license fee charged by Monsanto anywhere in the world. They charge about one-tenth this rate in China and Brazil. MMB produces its Bt cotton in India as a hybrid, not as a true breeding variety. The other companies have followed this trend as well. This consolidates their monopoly. Farmers cannot save seed from hybrids and must buy fresh seed every season. In the case of true varieties, they can save seed from their harvest and plant the next crop. The financial burden on the farmer is lower. Besides, the Bt cotton strategy for pest control works better in a variety which contains two Bt genes, than a hybrid which contains only one Bt gene and is therefore only half as effective as the true variety. The Andhra Pradesh government had banned the sale of MMB Bt cotton in the state following the company's refusal to pay compensation to those farmers who had suffered losses because their Bt cotton had failed to perform as claimed. The Andhra Pradesh government subsequently asked MMB to reduce the exorbitant license fees they were charging to something more reasonable, so that the seed could be more affordable to farmers. The steep price of GM cottonseeds was recognized by the government's investigative agencies as a major reason why the economics of Bt cotton was not working for many farmers. When MMB refused to reduce their seed price, the Andhra Pradesh government and two farmer organizations moved the Monopolies and Restrictive Trade Practices Commission (MRTP C) against the company in January 2006 for charging "exorbitant" royalty for Bt Cotton. On the instruction of the Monopolies and Restrictive Trade Practices Commission, the matter was investigated by the Director General of Investigation and Registration (DGIR). The DGIR report stated that MMB had failed to provide any rationale for the exorbitant license fees it charged. As there was no competition, the company was in a position to charge for the technology arbitrarily and unreasonably, thus establishing a monopoly. In an interim ruling the MRTP Commission had directed Monsanto to reduce its technology fee in India to the rate it charges in China. Anticipating this MMB had unilaterally reduced its license fee to Rs 900 per bag but the MRTP Commission ruling could require Monsanto to cut down its license fee still further. Having been indicted by the MRTP Commission, MMB has moved the Supreme Court challenging the order of the MRTP Commission directing it to fix a reasonable price for Bt cotton. The matter is sub judice. In the meantime, the number of farmer suicides has been on the rise in cotton growing states, particularly Maharashtra and Andhra Pradesh. Indebtedness has been identified as the major cause for farmers taking their lives. Bt cotton is a very expensive technology, which has not worked in dry land areas, adding to the debt burden of farmers. Many believe it has made a bad situation worse, leading to the ultimate tragedy of suicides. The cotton economics in India is confused and the government's cotton policy is not clear. At the time of approving Bt cotton, GEAC had said this technology was not recommended for small farmers, yet it did nothing to enforce this requirement nor did it make any effort to generate awareness among farmers to explain why this expensive technology was too risky for them, particularly in the rainfed areas. Instead of protecting the small farmers' interests, the GEAC approved Bt cotton varieties for the entire cotton belt and allowed small farmers to suffer irreversible financial losses. The confusion on Bt cotton does not stop there. On the one hand the government is promoting cotton cultivation and on the other hand, it imports cheap cotton from China even as domestic stocks lie unsold. The social and economic impacts of Bt cotton in such a situation are many and need to be studied. The advent of Bt cotton technology in an agriculture situation where a large number of cotton farmers are small, resource poor farmers in dryland areas who have low literacy levels, needs to be examined systematically in order to assess the relevance of this technology to Indian agriculture and its small farmers. The Bt cotton example should teach us that the social, economic and political impact of this technology needs to be understood in order to better identify the path of technology adoption that developing countries should follow when expensive transgenic technologies are on offer.   ]]> <![CDATA[GM regulatory process, a multilateral experience]]> https://biospectrumindia.com/news/95/7379/gm-regulatory-process-a-multilateral-experience.html https://biospectrumindia.com/news/95/7379/gm-regulatory-process-a-multilateral-experience.html Wed, 07 Mar 2007 12:42:00 +0530 New Page 1 GM regulatory process, a multilateral experience Dr GK Garg, former advisor biotechnology, GB Pant University and now director (R&D) with Krishidhan Seeds Ltd, has seen introduction of GMOs from different positions-as part of regulatory system, as a biotechnologist in the university system and as an industry person. He shares his integrated perception on the past, present and future of the regulatory process. Ivividly remember that the possibility of introducing foreign gene or through invitro manipulation of DNA became a distinct possibility when both Paul Berg and Stanley Cohen presented their work in a workshop on plasmids organized in New Orleans in January 1974, which I attended with Dr IC Gunsalus, my mentor at University of Illinois. Scientists themselves felt that caution was needed to undertake these studies. This concern found expression in invitation to all scientists who were involved in relevant work to ASILMORE conference in 1975. Indian scientists led by Late Dr NK Notani from BARC took the initiative in developing a self regulatory process for recombinant DNA technology work in India. These scientific concerns in both the countries led to placement of well debated and discussed regulatory provisions in place. The process was accelerated with the establishment of a separate Department of Biotechnology (DBT) under the Ministry of Science in 1986. The first guidelines were made available in 1989, which led to proper legislation and establishment of formal regulatory system at all levels. Care was taken that all perceived risk, no matter, how improbable they seemed, were tackled. Procedures for various experiments for development of products as well as waste disposal were defined to ensure release of GMOs only after ensuring that there will be no threat to environment. There were always debates to counterweigh the possible benefits to health, agriculture and environment and perceived threats to the same. As soon as transgenics became a reality in the US, intense debates preceded on acquisition of Bt cotton technology from Monsanto. Curiously, the public sector money was used to fund an interinstitutional team to develop an indigenous Bt technology in cotton, which was felt necessary due to the spurt of suicides by AP farmers attributed to the failure of their cotton crops. At the same time, the import of Monsanto technology was also permitted, under the Mahyco-Monsanto tie-up. This being the first test case, it was indeed an experience to participate in monitoring of multilocation and large-scale trial. I vividly remember the extra cautious approach of members of our monitoring and the evaluation team, exasperation of MMB people, calm, composed perseverance of young Raju Barwale and more than this the mixed expression of curiosity and hope on the faces of farmers. The first permission for commercial release took almost seven years from the date import of gene was permitted. The introduction of Bt technology changed the whole cotton scenario. Three companies, which had dynamic leadership, immediately recognized the potential of this technology and swiftly tied up with MMB to introduce Bt genes with their own elite hybrids. Krishidhan Seeds Ltd introduced the concept of integrated R&D, production, marketing and extension, which facilitated the farmers to adopt new technologies confidently. I am thrilled that there is a renewed interest and enthusiasm in the farmers. This reflects the success of the technology. The entry of more than one gene from India-Dr Rakesh Tuli (NBRI) and Dr Sen (IIT)-as well as those from abroad in a large number of released hybrids and those in the pipeline has ensured the necessary diversity in genes and genetic base very often emphasized by eminent scientists like Dr MS Swaminathan. It is interesting to note that in this backdrop of success, we do hear clamor raising doubt on the real benefits of the technology and which are difficult to comprehend on sound scientific terms. I have felt amazed by emotions of some of the environmentalists to oppose a technology that uses only natural scientific process albeit with human intervention. For example, agrobacterium has been transferring genes across the species much before the scientists have even learned about its basic principles. Debates get emotionally charged without realizing that alternatives like biocontrol agents, botanical pesticides have limitations in efficacy and magnitude and Bt technology gives protection against excessive pesticide usage, which is known to have deleterious effect on human health and environment. During monitoring visits, it was not uncommon to hear the use of up to 30 sprays on crops causing health problems to the person who sprayed. Misplaced environmental concerns have led to excessive pressure on regulatory process. While on one hand, one would like to reach this technology to each of the micro niches of agri-eco zone which will require conversion of multiple genotypes, on the other even for de-notified multi-location and SAU (State Agricultural Universities) testing is required which puts enormous pressure on this system. The confederation of the Indian textile industry has projected requirement of 45 million bales by 2012 out of which at least 20 million bales will have to be ELS cotton. To meet these targets and so also not to compromise on food security, tremendous R&D efforts will be needed to enhance productivity and quality of all food and cash crops including vegetables and cotton. During my visit to Mexico and the US, it was interesting to learn that countries like the US have not compromised with bio-safety issues but have kept their regulatory systems dynamic. Once convinced that a technology is safe, they have not hesitated to deregulate it. There is a tremendous amount of transparency and interaction with the industry which permits thorough examination of issues across the table. The environment becomes very friendly for sectoral growth and wealth generation, which is much needed in the agriculture sector if the benefit of economic growth has to reach rural areas. It is heartening that India too has kept its system dynamic. Bt technology has been already partially deregulated. I feel the time has come for the government to concentrate only on bio-safety issues and not to get unduly concerned with the product suitability and quality, which the market can take care of. Our industry and farmers have become discriminating and quality conscious. Therefore, no substandard product can survive in the market. Farmers now do demand accountability and compensation from the industry if product fails to meet the claims. Setting of guidelines and random monitoring of compliance will be more effective than an elaborate process of involvement of third party in regulatory clearance. A hassle-free procedure is the best way to meet the requirement of growth and quality. I have every confidence that in face of the fact that GMOs so far have proven harmless we are only couple of years away from liberalization and reforms in regulatory processes to accelerate the envisaged growth of agriculture sector.   ]]> <![CDATA["Bt cotton experience has indicated that the technology has been beneficial to farmers"]]> https://biospectrumindia.com/news/95/2553/bt-cotton-experience-has-indicated-that-the-technology-has-been-beneficial-to-farmers.html https://biospectrumindia.com/news/95/2553/bt-cotton-experience-has-indicated-that-the-technology-has-been-beneficial-to-farmers.html Wed, 07 Mar 2007 12:36:00 +0530 New Page 1 "Bt cotton experience has indicated that the technology has been beneficial to farmers" -BS Parsheera, Chairman, GEAC The Genetic Engineering Approval Committee (GEAC) is the country's apex regulatory authority on the approval of genetically modified crops. In an exclusive interview, the first one by the head of GEAC in the last five years, BS Parsheera, Chairman, GEAC and Additional Secretary, Ministry of Environment & Forests, takes us through the trials and tribulations in the journey of India's first biotech crop-the Bt cotton. There is a lot of controversy regarding the merits of GM cotton even today, five years down the line. What is your view on this? The Bt cotton experience in India has been very positive and encouraging. Bt cotton containing cry 1 Ac gene (MON 531 event) of Monsanto was the first transgenic crop released in India in April 2002 with the approval of the Genetic Engineering Approval Committee (GEAC), constituted by this Ministry under Rules 1989 of Environment Protection Act (EPA). Subsequently, 62 new Bt cotton varieties have been released. In April 2006, the GEAC has released Bt cotton varieties containing three new gene events namely cry 1Ac gene (event-1) indigenously developed by JK Agrigenetics in collaboration with IIT Kharagpur, encoding fusion genes (cry 1Ab+Cry Ac) GFM, developed by Nath Seeds in collaboration with China and Bollgard-II developed by Mahyco. In addition, the GEAC has approved 124 Bt hybrids for large-scale trials with cry I Ac gene and new gene event. The Bt cotton experience has indicated that the technology has been beneficial to farmers. The total area under Bt cotton has exponentially increased from 72,682 acres in 2002 to 86,00,000 acres in 2006. The total estimated production during 2005-06 is about 25 million bales (of 170 kg each). Bt cotton has reduced pesticide usage by 2260 MT of pesticides. The state-wise productivity of cotton during pre and post Bt cotton (lint Kg/ha) is as follows: Except for a few pockets in dry areas like Warangal (Andhra Pradesh) and Vidarbha (Maharashtra), the response to Bt cotton has been positive. The Supreme Court has directed the GEAC not to give approvals to GM crops until further orders. What is the approach adopted by the GEAC regarding the case and how is the committee taking the case forward? We have taken a stand before the court that the introduction of GM crops in the country is being done after elaborate procedures for risk assessment and bio-safety issues based on case-to-case protocols. And only after fully satisfying ourselves on the bio-safety aspects, the release of the crop is approved. The entire process of assessment is done by an expert committee, which does not have any clash of interest, along with some of the representatives of the ministries concerned. It is done in an absolutely objective and transparent way. We also provide opportunity for NGOs and other interested formal groups to represent their case, if they have any, regarding any aspect of issue under consideration. We are expecting that the discussion would now start as we have already given our position in an affidavit to the court and so has the other party. We have also made an offer that if the Court so chooses, we are willing to make a detailed presentation of how exactly the procedure is followed, which is done by people who have expertise in the area and have a very objective view about the issues involved. Bir Singh Parsheera, Chairman, GEAC Bir Singh Parsheera hails from the Lahoul-Spiti District of Himachal Pradesh. Born in 1950, he completed his Bachelors degree from the Punjab University and earned a Masters degree (MSc) in National Development and Project Planning from Bradford University, UK. Presently he is the Additional Secretary in the Ministry of Environment & Forests, Govt of India and the Chairman, Genetic Engineering Approval Committee (GEAC). In 1973, during the initial stage of his career, he had joined the Indian Police Service but then moved to the Indian Administrative Service the next year. He has worked in various capacities in the States of Andhra Pradesh, Himachal Pradesh and in the Government of India. Some of the important posts held by him include Commissioner and Special Officer of Municipal Corporations of Vijayawada, Shimla and Hyderabad. He has worked in the department of Tourism, Health, among others, before moving to Government of India in the Ministry of Environment and Forests for a period of 5 years. On his repatriation, he worked as Managing Director of Sports Authority, Managing Director of APHC and Secretary (Co-operation & Marketing) in the State Government. Thereafter in January 1997 he went again on deputation to the Government of India and worked there in different capacities until November, 2003. After coming to the State he briefly worked as Direcotr-General of EPTRI & Agriculture Production Commissioner and Principal Secretary, Dept, of Horticulture & Sericulture, Govt. of Andhra Pradesh before moving to the present assignment. What were the hurdles the GEAC faced during the approval of the first GM cotton hybrids way back in 2002? Since it was the first GM crop, the regulatory agency was extremely overcautious leading to a period of seven years testing before it was approved. The emphasis at that point of time was to assess the efficacy of the technology and not much importance was given to the genetic background of the hybrids. The GEAC also had to face a lot of opposition from several quarters. However, international experience with Bt cotton and data available on the bio-safety studies did help the committee to take a final view. During its initial days, the GEAC faced a lot of flak regarding its functioning. How have the processes been streamlined now? In the beginning there were some problems in terms of transparency, etc. In the sense that the website was not ready. So there was room for some doubt. But recently now we have ensured that all our agenda notes for every meeting of the GEAC are put on the website and the minutes of the meeting are also put there along with our detailed reason as to why we have chosen a particular course of action. We also have been giving opportunity to the NGO representatives, whenever they come up with specific issues to make a presentation before the GEAC to give their reasons as to why something should be done or should not be done. As India's apex regulatory authority on the approval of GM crops, what is the role that GEAC envisions for itself in the years to come? As an apex body notified under the EPA, 1986, the GEAC will have to maintain a balance, that is, play a proactive role in the regulation of GM crops to facilitate approvals without compromising on the safety aspects. Measures would have to be taken to ensure continuous post release monitoring to ensure timely remedial measures (delay in insect resistant development etc.). The post release monitoring will also ensure improvement in the pre release bio-safety assessment. With the ongoing research on many biotech crops, how is the authority equipping/strengthening/innovating itself for the future? Can other government agencies play a role in facilitating the approval process? In India there has been a spurt of interest in GMOs with the granting of Bt cotton approval in March 2002. Further in view of the biotechnological advances, worldover there has been an increase in production, export and import of GM food and food products. With the Cartagena Biosafety Protocol (CBP) coming into force on July 11, 2003, globally there has also been a growing demand for the governments to make stringent laws for food safety assessment before market authorization is permitted. The CBP also stipulates certain procedures for decision-making and risk assessment. Various stakeholder ministries have initiated or are in the process of evolving a GM policy pertinent to their sector. Some initiatives which are under active consideration are listed below: Food Safety and Standard Act, 2006 by Ministry of Health National Biotech Regulatory Authority by DBT GMO Policy on Labeling by Ministry of Health Incorporation of the GMO policy in the foreign trade policy by DGFT/Ministry of Commerce. With the new initiatives coming into force, the administrative ministries would play a major role in facilitating ongoing research, monitoring and approval process for GM products. Has the government ensured adequate public awareness in the Bt crops arena? The need for public awareness and training has been adequately addressed by this ministry and the Department of Biotechnology (DBT) since 2002. While the emphasis for training was initially restricted to nine cotton-growing states, the training and awareness programs have been extended to other states only during 2006. Further, the Ministry of Environment and Forest (MoEF) is implementing a GEF-World Bank aided project on Capacity Building for bio-safety to address issues related to transboundary movements of Living Modified Organisms (LMOs). The Capacity Building Program also addresses the issue of improving and enhancing the Genetically Modified Organism (GMO) detection facilities at four national institutions. Recently, the Ministry of Agriculture has initiated a major program to increase awareness among the state and district level agencies to ensure effective pre and post release monitoring. Does India have a structured risk assessment system in place for valuating the Bt crops? Yes. India has a structured risk assessment system, which is well defined in the Biosafety guidelines of 1998. Further, on a case-to-case basis specific protocols are prescribed by the Review Committee on Genetic Modification (RCGM). Any company involved in the development of GM food crop has to undertake extensive bio-safety assessment, which includes environmental safety assessment as well as food and feed safety. The environmental safety assessment includes studies on pollen escape out-crossing, aggressiveness and weediness, effect of the gene on non-target organisms, presence of the protein in soil and its effect on soil micro-flora, confirmation of the absence of Terminator Gene, baseline susceptibility studies. The food and feed safety assessment studies include composition analysis, allergenicity and toxicological studies and feeding studies on fish, chicken, cows and buffaloes. In case the transgenic crop is found to be not suitable for human consumption, the product is rejected during the trial stage itself. The agronomic testing includes evaluation of the stability of the introduced trait, efficacy of the technology and the agronomic performance vis a vis its non-GM counterpart. What is your message to the companies working in the area of GM crops? The development of transgenic crops should be need-based and address the country's specific issues related to food and livelihood security. There should be no compromise on the bio-safety studies and the companies should be ready to face full accountability in case of any mishaps. Companies should play proactive role in enhancing the awareness of their products as well as be vigilant during the post release period. Would you like to say something to the NGOs running an aggressive anti-GM campaign in the field of agribiotech? The NGOs should be open to others' point of view and not impose their mandate of anti-GM policy on the country. They should play a proactive role to ensure that the government is vigilant and takes timely action where required. The arguments for a moratorium on GM products should be based on scientific facts and not on fictitious propaganda such as sheep death due to consumption of Bt cotton leaf, etc. The introduction of any new technology may have both beneficial and adverse impacts and requires careful evaluation of the long-term sustainable benefits. In the case of modern agricultural biotechnology, the benefits as well as risks would vary from crop to crop, region to region and technology to technology. Therefore, the moot point is to ensure that a cautious step-by-step approach is adopted and a comprehensive evaluation of risk versus societal benefits is ensured before taking a final view. Therefore, scientific assessment and not moratorium is the answer to address bio-safety concerns. In accordance with the precautionary approach, the government is following a policy of case by case approval for transgenic crops. After Bt cotton, which is the next crop likely to get the GEAC nod of approval? While there are several GM crops under various stages of testing, the next crop that is under consideration of the GEAC is Bt brinjal developed by Mahyco. Rolly Dureha ]]> <![CDATA[Chidambaram bats for biotech]]> https://biospectrumindia.com/news/95/8240/chidambaram-bats-for-biotech.html https://biospectrumindia.com/news/95/8240/chidambaram-bats-for-biotech.html Wed, 07 Mar 2007 10:43:00 +0530 Chidambaram bats for biotech Chidambaram bats for biotech ]]> <![CDATA[India can attain global leadership in biotechnology]]> https://biospectrumindia.com/news/95/1777/india-can-attain-global-leadership-in-biotechnology.html https://biospectrumindia.com/news/95/1777/india-can-attain-global-leadership-in-biotechnology.html Wed, 07 Mar 2007 10:42:00 +0530 India can attain global leadership in biotechnology India can attain global leadership in biotechnology Mukesh Ambani Chairman and MD Reliance Industries Limited We are on the verge of a new revolution. A revolution brought about by biotechnology. The twentieth century belonged to physics and chemistry. The twenty first century will belong to biology. Mukesh Ambani, Chairman and Managing Director, Reliance Industries Limited is convinced that the Indian industry is set to climb new peaks of innovation and creativity and is destined to attain global leadership in biotechnology. In an exclusive column to BioSpectrum, Mukesh Ambani outlines the key imperatives for success. History tells us that a transition from science to technology matures over decades before it starts to influence society in a fundamental way. We saw this in physics with the advent of the science of heat engines, electricity and computing. Humanity benefited immensely several decades later through technologies in transportation, electrical equipment, electronic devices and computers. We also saw this in chemistry with the advent of inorganic and organic chemical sciences. Mankind stood to gain enormously after several decades through technologies to manufacture pharmaceuticals, plastics and advanced materials. But when it comes to biology, we are seeing this transition only now. The 1960s and 1970s saw the emergence of genetic, protein and cell sciences. These biological sciences are now beginning to impact society through technologies in genetic engineering, recombinant proteins, monoclonal antibodies and tissue engineering. Physics and chemistry altered living. But biology will transform our very lives. Physics and chemistry led to discovery of elements in nature that led to the development of a whole range of new synthetic materials. But biology discovered the code of life, or genome, which will lead to transformation of life. Biotechnology will thus bear upon humanity at its very essence. It will fundamentally transform existence in three ways-the basis of life, the basics of living and the base of living systems. We are therefore talking of the opportunity in biotechnology that, by its very genetic constitution, is global. Biotechnology will touch every single life on this planet-from over six billion people to millions of plants, animals and aquatic species and microorganisms. This will happen in three ways-improving the quality of life, controlling the form of life, and extending the duration of life. Biotechnology, a much larger opportunity India has a unique opportunity to ride the biotechnology revolution. Biotechnology, to my mind, will be a much larger opportunity for India than information technology. This is because information technology is limited to the process of productivity and human living. On the contrary, biotechnology is expansive to the process of procreation and human life. India has several factors going for it to attain global leadership in biotechnology. We have varied agro climatic zones that bring to life every conceivable plant, animal and aquatic life. We have one of the largest professional resources trained in biology in the world. These include several centers of educational excellence in universities and national laboratories. We have several overseas Indians at the leading edge of biology research in universities in the US and Europe. We have a strong framework of public funded research institutions in biological sciences in medical and agricultural domains. Our tradition in plant research is commendable. We have a network of plant breeding and plant genetics laboratories. We have a fair number of modern tertiary care hospitals to facilitate clinical studies. Our patient population for fast track clinical trials is significant. We have a strong pharmaceutical industry. Above all, we have a market that makes up one-sixth of humanity. Imperative measures India's endowment in biotechnology is only one part of the story. It is not alone enough. India needs to ignite the potential and the promise of the biotechnology industry. This will call for several imperatives. Fire innovation: Foremost among these imperatives is to fire innovation in our research labs. Our research institutions must be geared to nurture innovation. They must be at the forefront of the technology envelope. To attain this, we must create a competitive and demanding research environment. We must take bold national initiatives in several frontier research areas of biotechnology, such as genomics, proteomics, pharmacogenomics, cell biology, tissue engineering, biopharmaceuticals and plant metabolic engineering. We must also get the private sector to give up its nonchalance towards research and development. Many innovations in the developed world have come out of the private sector. These have been facilitated by a climate of sizeable public funding, surpluses from traditional businesses of large corporations, protection for intellectual capital, vibrant venture capital participation, competitive market place and a demanding environment for academic researchers. India must work to create such a climate for innovation. Develop professional resources: The second imperative is in developing professional resources in biotechnology. Research-led higher education in biotechnology will be basis for innovation. India needs a large number of research-led institutions in biotechnology. Only this will lay the foundation for global leadership in this domain. Develop affordable BT solutions: The third imperative is to develop biotechnology solutions in an affordable manner. In the developed world, biotechnology has always come up with expensive solutions to problems in medical, plant and industrial biotechnology domains. This will not be acceptable in the Indian environment, given the socio-economic profile of the Indian consumer. It would also not help leverage the cost-volume tradeoff so typical of Indian markets. Therefore, it is imperative that cost economics are constantly on the radar screen of discovery and development efforts. Fortunately, we have the means to achieve aggressive cost positions in biotechnology. Our research costs are about a third of those of the western world. Our development costs are also in the same vein, given the shorter patient accrual periods for clinical trials and relatively lower health care costs. Create conducive environment: The final imperative for India is to create a conducive environment for the industry. Biotechnology, and for that matter other emerging technologies, are characterized by a large number of strategic alliances. This will call for research, clinical and market collaboration across borders. Barriers to these collaborations in the nature of government agency approvals and transfer of biological material must be done away with. Reliance is fully tuned to the potential of the biotechnology industry. Reliance Life sciences envisions bringing biotechnology to better life, living and living systems in a cost-effective and sustainable manner. Cost-effective from the point of affordability to millions of users, first in India and then in other parts of the world. Sustainability from the point of view of the enterprise set in a capital intensive, research driven mode. Unlike other biotechnology companies in the world, Reliance Life Sciences has embraced a wide span in the biotechnology domain. It is engaged in research-driven initiatives to understand science, technology, scale-up and cost economics issues. This will enable Reliance Life Sciences to configure a business based on what makes sense and what works best in an emerging technology area. Reliance Life Sciences envisions discovering and developing new therapies for intractable and incurable diseases through stem cell biology, tissue engineering, molecular biology, molecular genetics, therapeutic proteins and new drug molecules. On the industrial side, Reliance Life Sciences is engaged in developing biopolymers and biofuels to defend the global leadership position of Reliance in polymers, polyesters, processes and fuels. These initiatives will yield results in the clinical domain during the later part of this decade. Wheels of history turn periodically. We are witnessing a similar process before our eyes. I believe we can make the twenty-first century the India century. Biotechnology has the potential to significantly contribute to this aspiration. Empowering India All the essential ingredients to make India a great power in these areas are within our reach. A variety of favorable factors have arisen in the twentieth century to nurture these seeds and help them to grow into a mighty force. These include a critical mass of educated and skilled young men and women, strength of institutions of science and technology, a new sense of self-confidence amongst professionals, and last, but not the least, unleashing of the productive energies of the private sector. I am convinced that India is set to climb new peaks of innovation and creativity and is destined to attain global leadership in biotechnology. ]]> <![CDATA["Gujarat plans to build a world class biotech cluster"]]> https://biospectrumindia.com/news/95/4143/gujarat-plans-to-build-a-world-class-biotech-cluster.html https://biospectrumindia.com/news/95/4143/gujarat-plans-to-build-a-world-class-biotech-cluster.html Wed, 07 Mar 2007 10:28:00 +0530 New Page 1 "Gujarat plans to build a world class biotech cluster" - Narendra Modi, chief minister, Gujarat India's leading industrialized state, Gujarat, is also home to some of the country's leading pharmaceutical companies. However, the transition from core pharmaceuticals to biopharma and biotechnology has been somewhat slower than in other leading Indian states like Maharashtra, Karnataka and Andhra Pradesh. The state, under the visionary leadership of its charismatic chief minister, Narendra Modi, is now leaving no stone unturned to catch the biotechnology wave. Gujarat has set up a special agency, the Gujarat State Biotechnology Mission (GSBTM) to push the state into the frontiers of biotechnology in a systematic way. Modi has courted investors from around the world in various sectors to make Gujarat their home and particular attention was bestowed on biotech leaders last January. A number of innovative initiatives have been planned by the state to become a leader in biotechnology sector in a very short time. Industry leaders and technocrats speak highly of the chief minister's personal attention to the biotech sector. In between setting the agenda for his government at the ongoing Assembly session and wooing investors and criss-crossing the state preparing to seek yet another mandate from the people to rule the state for five more years, a relaxed Modi outlined his biotech vision for the state in an exclusive interview with BioSpectrum editors, Narayanan Suresh and Narayan Kulkarni. There was jubilation all around. The results of the Punjab and Uttarakhand elections had just come in with the CM's party, Bharatiya Janata Party (BJP), making stunning victories in these states. Sweets were being distributed to all visitors and there was an endless stream of visitors who had thronged his office in the Assembly building to celebrate the occasion. Instead of getting sidetracked by the jubilation around him, Modi spoke clearly about India's inherent strengths in acquiring and handling specialized knowledge, and how the state and the country will set an example to the world in utilizing the fruits of biotechnology for a greater common good and usher in a healthy society. Excerpts: You have coined the term BT+BT = BT (Bharat Today + Biotechnology =Bharat Tomorrow). Considering this, what could be the contribution of Gujarat one can expect in Bharat Tomorrow? Gujarat has been the one of biggest contributors to Bharat Tomorrow. The lead entrepreneurs in biotechnology from Gujarat, have been making their mark nationally and internationally. Gujarat has been amongst the first few to adopt the agro-biotechnology and emerge as a major cotton producer. The lead taken by Gujarat is being replicated by other states. The proven success of cotton in India owes a great deal to Gujarat. The biotechnology industry is going to make tremendous contribution towards better health care products, more nutritious food and cleaner environment. In the coming times, the emphasis would be on producing life saving biotech drugs for which patents have already expired. Such drugs are in abundance but are very costly. Gujarat has a history of producing drugs at affordable prices and in consonance with this tradition Gujarat would take lead in this area. Gujarat, with its favorable geographic location, diverse climatic conditions, rich marine and microbial biodiversity, would like to make drugs and therapeutic products for the country and human society at affordable prices. Better yielding groundnut, value added products from castor, biotechnology based vaccine, both for human as well as animal healthcare, higher availability of dairy based products, trendsetting technologies and practices in medical and solid waste treatment, are few of the areas in which Gujarat expects to contribute to Bharat Tomorrow. Gujarat has been a late starter in IT but is gaining momentum. How are you placed as far as biotechnology is concerned? There is cultural and traditional background for every economy and adaptation to change takes some time. Gujarat is certainly picking up momentum in IT. The recent IT summit, which evinced high interest is indicative of it. The commitment of investments to the tune of Rs 11, 000, crore in IT is an encouraging sign. As far as biotechnology is concerned, Gujarat has been in biotechnology for many years. Alembic was established here long back in early 1970s. The biggest diagnostic company of the country-SPAN, is in Gujarat. Think of the biggest vaccine producer and supplier, Chiron, it is located in Gujarat, think of upcoming company coming up with recombinant productsâ€“INTAS, it is here, think of company working in enzymes-Concord, it is here since the last six years. Probably with more than 45-50 BT companies and turnover of around Rs 450-500 crore, Gujarat would rank among top five states of the country. Gujarat is determined to build further from this base. What proactive role do you envisage for biotechnology to be an early gainer in the next decade? The state has taken definite pro-active actions on organizational, planning and implementation front. The Gujarat State Biotechnology Mission (GSBTM) takes care of the organizational part. Developments of long-term vision, biotechnology development strategy, sector specific strategic road maps, are crucial actions from the planning angle. Development of infrastructure, developing skilled human resources, supporting biotechnology research, encouraging biotech entrepreneurship and business are the main priorities from the implementation perspective. Sector specific BT Parks, agro-BT park, marine BT park, specific facilities like marine resources center, dedicated value addition training programs, both in universities and in collaboration with industries, focus on teachers' training, modern infrastructure for biotech research in universities, establishment of biotechnology venture fund, are few of the pro-active actions of the state government. In coming five years, the state government plans to allocate nearly Rs 200 crore to biotechnology. The Gujarat government has taken many initiatives in promoting biotechnology. Still most of the investments are coming mainly from the local (Gujarat-based) players for their expansions. What would be your strategy to attract new entrepreneurs to the state? The growth of entrepreneurship starts from a strong base and Gujarat has a very strong pharma base. It is also a pleasant co-incidence that almost 68 percent of biotechnology revenue comes from the pharma biotech or healthcare biotech. It is also a known phenomenon that existing companies diversify into new coming sectors. Therefore, Gujarat being the land of entrepreneurs and having distinct advantages, is bound to have biotech investments from local (Gujarat-based players). It is a positive development, an assured development. Just as the local pharma players made Gujarat a national and global strength, the same is bound to happen in biotechnology as well. This serves to provide a comfort level for global players who would look at it as an ideal playground. Nevertheless, in times of globalization, the state looks for global investment. While Gujarat has excellent industrial and social infrastructure in terms of roads, airport, connectivity, power availability, labor aspects etc, the strategy is to develop world class infrastructure in terms of BT clusters, BT Parks, research facilities, skilled manpower, required for a wide spectrum of the BT sector. Although Gujarat has reputed universities, shortage of skilled human resources in terms of quality manpower is a major concern to the biotech community. What will be your strategy to improve the situation? As I mentioned earlier, the overall tradition and culture of economy dictates the need, quantity and quality of human resources. MSU has been one of the oldest universities, running BT related courses and its alumni are scattered all over the globe. In recent years, other state universities are also coming forward with BT related educational programs. The state has taken stock of the existing scenario of BT education. As a first step, a blueprint of HRD development has been developed. Apart from skills improvement programs for students and the teaching faculty, establishing a few dedicated institutes like the Institute of Biotechnology Education, Institute of Marine Biotechnology, Institute of Clinical Excellence are on the anvil. The state would be establishing these institutes jointly with the Central government and private partners. The Bt cotton controversy appears to have given a setback to agro-biotech companies. How does Gujarat intend to invigorate the agro-biotechnology sector and the investments therein? There is always a time gap between understanding the technology and its implications. Bt cotton was one such example, which surfaced as a local high-end desire to achieve excellence through entrepreneurship. While having high regard for regulatory provisions, the state wants to provide a fair playing ground for agro-biotechnology. Gujarat with its specific regional strengths offers a large scope for agro-biotechnology. Being a leading producer of castor, groundnut, pigeon pea, chickpea, isabgol (psyllium seed husks), cumin, tomato, potato and mango, Gujarat offers a huge potential of investment and business through value addition. Incidentally these are also the crops in which biotechnology work is in the advanced stage. Due to the increased water availability through the Narmada canal system, there is vast scope for cultivation of value-added crops. The location cum feasibility study is being conducted for developing an agro-biotech park in the state. The state also plans to establish dedicated incubation facilities, research infrastructure in agri universities to provide support to prospective investors in agri-biotechnology. Gujarat has huge marine resources. For realizing the potential of marine biotechnology, what is the strategy for development in this field? The abundance of resources is one thing and having capabilities, technologies and its conversion into products and processes is something different. The marine resources sector is one such sector which has potential, but is in its nascent stages. While many European countries are going in a big way, India is also making a beginning and Gujarat, having the longest coast line, is also eyeing it with interest. However, it needs resource database, skilled manpower, dedicated research and above all- technologies for business. Gujarat is taking strategic initiatives like establishing a marine resources center, supporting dedicated PG programs in marine biotechnology, marine incubator, and its extension into a marine biotechnology park. The project of the marine resources center and incubator has been submitted to the Central government and is expected to be included in the 11th Five Year Plan. Though support from the Central government has been sought, the state would also take initiatives from its own resources. As the first step, the state government has supported the development of a Center of Excellence in Marine Biotechnology, which is focusing on seaweed cultivation, having backward linkages with industry. Gujarat being one of the leading pharmaceutical bases of the country is now losing investments to other north Indian states because of their offerings to the entrepreneurs. How do you wish to address this issue? The key parameters for industrial development and industrial investments are urban, social and industrial infrastructure. Gujarat has been providing it since long and that is why it has been in forefront of industrial development. However, the entire country and all its states offer options and choice. Gujarat, while welcoming the pro-active role of different states, stands committed to provide the facilities, which are key for sustained operations and business in the long term. Gujarat with its industrial infrastructure, power availability, labor and employment, investor-friendly business environment, would continue to attract industries. Better infrastructure base, assured power supply, social infrastructure would continue to be the state's offering for future and prospective BT investors. And in this respect, the state's government vision of developing a mega city is one such initiative to attract investors from different parts of the world. Gujarat has many biopharma companies with manufacturing facilities, but not as core R&D companies. How does the government intend to promote research-based biotech initiatives in the state? The state is already providing funding support to biotech research. The state has developed a dedicated action plan for promoting biotech research. It has identified sector-specific facilities, and institution-specific facilities, which would be developed alone or through collaborative funding. The state plans to make universities and educational institutes into a hub of biotech research, develop modern biotech research and incubation facilities in different universities, encourage researchers and faculties to undertake collaborative projects. Active research by existing teaching faculty is one of the priorities. The state plans to take stock of the present research scenario and would work out the priorities. Gujarat is the first amongst the first few states to witness the establishment of Clinical Research Organizations (CROs) in India in the late 1990s. But the current strength of CROs is not very impressive as would have been expected in the state. What would be your strategy to attract CROs to the state? In the last few years, new CROs have come to Gujarat. Paraxcel has collaborated with Gujarat-based Synchron. UK based VEEDA has landed in Gujarat through Gujarat-based Clinsearch. I have been told that Gujarat-based company JRF provides dedicated facilities for CROs. The existing units have undertaken expansion. This indicates that Gujarat still continues to attract CROs. The CROs need basic facilities for operation and the state government is committed to provide them. I am told that animal house is one such important facility. We shall be developing the same in the BT Park at Savli, as part of the BT Park plan. The state has developed Healthcare System Wide Area Network (HSWAN), which has linked the government hospitals virtually. The state government has developed a dedicated program for manpower development in CROs, which is under consideration by the Central government. The state would also take initiative from its own resources. As a visionary chief minister, what is your perception about biotechnology's role in building a healthy society? The role of modern technology should be to address certain aspects, which are otherwise not possible through existing technologies. Genetic disorders, blood related disorders are few of the serious diseases, which need specific tools, both for prevention as well as treatment. Thalassemia, sickle cell anaemia and other genetic disorders are serious diseases. Their diagnosis, treatment and prevention, are possible through a biotechnology-based approach. Diseases needing organ transplants are on the rise. The state government desires to see a healthy society free of such disorders and to be able provide affordable treatment options and facilities. Probably, facilities for genetic diagnosis, providing organ compatibility testing facilities, stem cell therapy, are few of the globally available options. The state government would focus on providing such facilities, which would address these aspects. ]]> <![CDATA[Dr Manju Sharma gets Padma Bhushan]]> https://biospectrumindia.com/news/95/6241/dr-manju-sharma-gets-padma-bhushan.html https://biospectrumindia.com/news/95/6241/dr-manju-sharma-gets-padma-bhushan.html Wed, 14 Feb 2007 11:07:00 +0530 New Page 1 Dr Manju Sharma gets Padma Bhushan Dr Manju Sharma, former DBT secretary, and Dr Ananda M Chakrabarty, the University of Illinois scientist who made history as the first holder of a patented gene in 1981, and Dr Vilayanur Ramachandran, the celebrated researcher on human brain based in San Diego, have been given India's top civilian honors. Dr Sharma, who played a key role in setting up the forerunner of the world's first biotechnology ministry at the government level, in the early 1980s and later headed it for six years till January 2004, was given the Padma Bhushan Award, India's third highest civilian award, on the occasion of India's Republic Day on January 26. Dr Sharma was the recipient of the second BioSpectrum Life Time Achievement Award in December 2004. BioSpectrum honors biotech industry leaders every year through these awards. After retiring from the Federal government, she is now an advisor on biotechnology to the government in the western Indian state of Gujarat. Home of India's generics pharma industry and the country's largest industrialized state, Gujarat is making itself an attractive destination for global biotechnology companies. "I am honored by the nation's recognition of my efforts to promote biotechnology," she told BioSpectrum. Dr Chakrabarty is the celebrated India-born scientist, now an American citizen, who fought a legal battle to win the right to patent a bacterium from the US Supreme Court in 1981. Dr Chakrabarty has also been advising India's DBT for over two decades on strategy. A strong supporter of the Bayh-Dole Act, Dr Chakrabarty's inputs have been vital to the formulation of similar legislation in India. Dr Chakrabarty has been given the Padma Shri Award, the fourth highest civilian honors given by the Indian government. Dr Vilayanoor Ramachandran, a well-know neuroscientist and researcher of the brain at the University of California, San Diego, has also been given the Padma Bhushan Award by the government. This Chennai-born scientist is the globally known author of the theory of "phantom limbs" and is said to be one of the global scientific leaders trying to unravel the complex working of the human brain by studying the neurons. The awards will be presented in March by the President of India, Dr A P J Abdul Kalam, in New Delhi. ]]> <![CDATA[Looming Talent Crunch]]> https://biospectrumindia.com/news/95/1364/looming-talent-crunch.html https://biospectrumindia.com/news/95/1364/looming-talent-crunch.html Thu, 08 Feb 2007 16:33:00 +0530 New Page 1 Looming Talent Crunch Industry leaders have been talking about the demand-supply mismatch in the availability of human resources for the growing biotech for some time now. The numbers are there but they do not match the specific requirements of the different segments of the industry. The last issue of BioSpectrum ranked the Top 20 private and publicly-funded institutions offering biotechnology and related courses in the country. Their numbers are growing and there are at least 300 top notch institutions. Then why is the industry still talking about the talent crunch? Biotechnology has always had a lot of emphasis on research. And the latest survey by BioSpectrum, using the data collected in the last six months clearly indicate that nearly two-thirds of the students coming out of these institutions head abroad for doctoral studies. So the industry has to depend on either Indian professionals working abroad to handle top research jobs. Or as many companies are doing, hire even foreign professionals to take up key positions in their organizations at the early stage of the evolution of the enterprises. Other knowledge industries are also facing a shortage of talent. So one is not sure whether biotechnology is part of the larger talent crunch facing an economy growing at over 8 percent consistently. As a nation, we have not prepared ourselves in many sectors to face such talent crunch. The national economy is making that transition to a high growth path, and like every other industrial sector, biotechnology too should be prepared to anticipate its needs much better. The recent issue of Outlook Business magazine highlighted the Indian industry's unlisted leaders. And Serum Institute of India, the No.1 biotech company according to the 4th BioSpectrum-ABLE Biotech Industry Survey 2006, found a prominent mention in the articles. The mainstream media too has started to give more attention to the biotech industry and this is a good sign. Biotechnology continues to hold considerable interest among the nation's top decision makers. And there is no better proof than the Padma Bhushan title, the nation's third highest civilian award conferred on Dr Manju Sharma, the former head of the Department of Biotechnology. BioSpectrum and the industry recognized her contributions in promoting the growth of this sector in the same year she retired from the government. The country has also recognized the efforts of Prof Ananda M Chakrabarty, the India-born, American citizen who got the world's first patent for a modified microorganism way back in 1981. The government while announcing these awards could do full justice to the awardees by publicizing the major contributions of the awardees. The bland announcements on the eve of the Republic Day every year does not do justice to the immense contributions made by many of the recipients. Also, the criteria used by the selection process and a greater transparency about the awards process will only enhance its appeal. Currently, the mass media highlights the names of a few popular awardees and it is left to many of the individuals or their organizations to indirectly blow the trumpet on these awardees. Meanwhile, India's biotech sector is getting ready to showcase its capabilities at the forthcoming BIO event in Boston in May. The DBT has taken the lead to bring all Indian participants under the single banner of India Pavilion, coordinated by the CII. More promising Indian companies and research institutions should participate in the Boston event. Countries like Singapore underwrite a major part of the promotional efforts to showcase the companies based in events like BIO Boston. The DBT and CII too should take steps to rope in more Indian companies by providing all necessary support in terms of infrastructure and financial resources. It will help the industry and the nation in the long run immensely. <sureshn@cybermedia.co.in> ]]> <![CDATA[BioSupliers News]]> https://biospectrumindia.com/news/95/1089/biosupliers-news.html https://biospectrumindia.com/news/95/1089/biosupliers-news.html Thu, 08 Feb 2007 16:30:00 +0530 Polystyrene plates for protein crystallization from Axygen Polystyrene plates for protein crystallization from Axygen For protein crystallization work, Axygen has introduced 24-,48- and 96-well flat bottom polystyrene plates, which can be used for hanging drop as well as sitting drop vapor diffusion crystallization experiments. AxyPearl, a high throughput hanging drop vapor diffusion crystallography lid is also available. In the hanging drop experiments, 96-well sitting drop plate can be used in combination with Axypearl. This combination enables 1 sitting and 2 hanging drop experiments to be conducted simultaneously for each of the 96 buffer well. For crystal recognition and imaging, specially designed softwares are available. They are first pattern recognition softwares, which can easily detect the difference between crystal and precipitate, even in difficult and ambiguous cases. For details, contact: axygen@vsnl.com Axygen Scientific introduces Axygen BioSciences Axygen Scientific, a known leader in plastic consumables, has ventured into the arena of genomics and proteomic-Axygen Biosciences, the life sciences division of Axygen. The primary goal of Axygen Biosciences is focused on addressing the requirements of the scientific communities throughout the world by providing innovative genomics, proteomics, drug discovery, and diagnostic tools and technologies. Its genomic range includes a wide variety of DNA isolation and purification kits, which covers plasmid DNA, genomic DNA, PCR clean up and gel extraction. Each kit includes all buffers, plasticware and instructions required to purify nucleic acids from starting materials. Kits are designed to meet or exceed the performance parameters of comparable products. Axygen Biosciences is a global leader in discovering protein structures. In proteomics, it offers a series of products and kits for the screening and purification of proteins and peptides. It creates platforms that limit and miniaturize the use of proteins while providing ultimate precision, accuracy, ease of use and integration, speed, and cost efficiencies. By developing unique consumables, reagents, software, and high throughput robotics, it has also addressed challenges faced in all protein crystallography laboratories. Thermo Fisher Scientific strengthens life sciences portfolio Thermo Fisher Scientific has acquired a Swiss company, SwissAnalytic Group AG, based in Basel that owns Spectronex AG and Flux Instruments AG, which had combined revenue of approximately $22 million in fiscal year 2006. Spectronex is a supplier of mass spectrometry, chromatography and surface science instrumentation in Switzerland, Austria, Slovakia and the Czech Republic. As Thermo Fisher Scientific expands its field sales presence in Europe, this acquisition will bring additional direct sales, demonstration capabilities and visibility to customers in these regions. Flux Instruments is a manufacturer of high performance liquid chromatography (HPLC) pumps and software. Flux brings new technology and design expertise to Thermo Fisher Scientific's current HPLC and LCMS business, which includes the new Thermo Scientific Accela UHPLC as well as advanced sample extraction and liquid chromatography products gained through the recent acquisition of Cohesive Technologies. Flux will enhance the company's product portfolio with complementary technologies and intellectual property for future product development. Marijn E Dekkers, president and chief executive officer of Thermo Fisher Scientific, said, "Flux Instruments is a strong complement to our expanding chromatography and life sciences mass spectrometry product lines. In addition, Spectronex enables Thermo Fisher to strengthen our footprint in Europe with direct sales channels and support, enhancing our ability to work closely with important customers in this area." Tulip Group diversifies into dehydrated culture media Goa-based Tulip Group of Companies, an in vitro diagnostics major, has forayed into the manufacturing of Accumix Dehydrated culture media, bases and high technology disinfectants through its division Microxpress and BioShields respectively. DG Tripathi, director, Tulip Group of Companies, said, "Intense research in both the product groups over the last two years has resulted in the development of world-class products whose quality is comparable to the best, internationally. In a technology segment where only few companies have conserved the know-how, is a breakthrough achievement for the group." He further said, "These two product ranges covering a gamut of over 300 products have a wide application in industrial, medical, hospitality and biotech industry. The products also have a huge export market. The products have already generated excellent review from the users." Commenting on the market opportunity, he said, "As against the global market size of about $1.2â€“1.4 billion, the Indian market is about Rs 150-175 crore, growing at a double digit figure." Gridlogics launches Patent Insight Pro Pune-based Gridlogics Technologies has launched Patent Insight Pro v2.8.5, an improved versions of its earlier product, with more features to the patent search, management and analytics product. Patent Insight Pro is a patent mining and analytics software product for desktop and enterprise users. According to a release, the software mines through patents to help researchers analyze technology and competitive trends. Patent Insight Pro helps organizations to identify most active competitors and understand their strategies, identify potential acquirers or licensing opportunities for your in-house IP, identify new application areas for existing IPs, identify patent/company acquisition opportunities, and strengthen current patent portfolio by filling up identified gaps. Manish Sinha, CTO of Gridlogics, said, "With the new release, we have made Patent Insight Pro blend into the way a patent researcher operates. We know that researchers will find it very easy to use and beginners too will immediately start functioning as professional patent researchers." Sartorius acquires Toha Plast Sartorius AG, a laboratory and process equipment provider, has acquired all shares in Toha Plast GmbH effective January 3, 2007. Toha Plast GmbH develops and manufactures plastic components for the medical and biotechnology branches and has been a long-term supplier and development partner to Sartorius in plastics technology including processing of thermoplastics and injection molding. The company has some 75 employees at its location in Goettingen and modern cleanroom production. The contractual parties of this acquisition have agreed to maintain the price of this transaction confidential. In July 2006, Sartorius had already purchased a relatively small Toha Plast production facility in Puerto Rico. By acquiring Toha Plast, the Sartorius biotechnology division is continuing to expand its technological expertise in the field of plastics. Injection-molded and thermoplastic components are integrated into all disposables supplied by this division, for instance, in filters, disposable bioreactors and disposable fluid handling bags for the pharmaceutical industry. The acquisition of Toha Plast is a further step for Sartorius in becoming the market leader in the rapidly growing market of disposables for biopharmaceutical production processes. Praj continues to receive orders from US firms Praj Industries, the global ethanol technology provider and renewable energy firm, continues to record significant order intake from the US. In the last quarter of 2006 (Oct-Dec), Praj contracted the second phase orders from Cilion for its Imperial County project as also from Missouri Valley Energy for its Meckling, South Dakota project. While the first phase (orders received earlier) involved supply of technology package, the second phase deals with supply of equipment. Additionally, Praj also received an order for US' first sugarcane-based ethanol project. The aggregate contract value of these orders is in excess of Rs 170 crore, a release said. The release noted that the Imperial County project is the third project of Praj for the Cilion Group. Cilion will produce 110 mgpy (400 mln litres per annum) ethanol from this facility. The order from Missouri Valley for a 55 mgpy ethanol plant heralds Praj's entry into Corn Farmer's Cooperative Sector in the mid-west of the US. In another major development, Praj got a breakthrough in the sugarcane belt of the US. Louisiana Green Fuels LLC has awarded a contract to Praj for an integrated 23 mgpy ethanol plant using sugarcane-based feedstocks. This plant will be located at Lacassine, Louisiana, adjacent to an exisiting cane syrup mill. "In the very first year of entry into the US, Praj has achieved sizeable business resulting into capacity addition in the region of 700 mgpy by way of Praj technology and equipment from many prestigious clients," said Shashank Inamdar, managing director, Praj. BioSuppliers News New Page 1 Agilent, Groton sign pact for pharma manufacturing solutions Agilent Technologies and Groton Biosystems LLC have announced an agreement to co-market solutions for the Process Analytical Technology (PAT) initiative for the pharmaceutical industry in the US and Canada. PAT is a system for designing, analyzing and controlling manufacturing by measuring critical quality and performance attributes of raw and in-process materials and processes, all with the goal of ensuring final product quality. The alliance is designed to benefit biopharmaceutical customers who perform in-process and final product testing in a wide range of production segments and who are looking for state-of-the-art online sampling with HPLC analysis for rapid quality-related decision-making. The agreement, expected to expand to Europe and Asia in the near future, brings together Agilent's world-class HPLC systems with Groton Biosystems' strong online sampling products and services. Groton Biosystems, based in Boxborough, Mass, specializes in providing biotechnology production companies with online and laboratory process monitoring solutions.   Bio-Rad, Axis-Shield sign pact for anti-CCP test Bio-Rad Laboratories, a manufacturer and distributor of life science research and clinical diagnostics products, and Axis-Shield, an in vitro diagnostics company, have signed an agreement that gives Bio-Rad access to Axis-Shield's test for the early detection of rheumatoid arthritis. The assay, which will run on Bio-Rad's BioPlex 2200 system, tests for anti-CCP (anti-cyclic citrullinated peptide antibodies). The anti-CCP assay is a significant recent development in the early diagnosis of rheumatoid arthritis, facilitating improved management of this widespread and debilitating condition. According to a press release, the BioPlex 2200 system is a fully automated, random access multiplex testing platform that can deliver up to 2200 results per hour. The system currently includes a panel of assays targeting autoimmune diagnostics. "The ability to incorporate an anti-CCP test as part of a rheumatoid arthritis panel will add significantly to our growing menu of autoimmune tests on the BioPlex 2200 system," said John Goetz, vice president and group manager of clinical diagnostics, Bio-Rad.   Waters releases control software Waters Corporation has released control software that now makes its ACQUITY UltraPerformance LC (UPLC) System compatible with Applied Biosystems/MDS SCIEX mass spectrometry products controlled by Analyst software. In conjunction with Applied Biosystems/MDS SCIEX's release of the latest update to Analyst V1.4.2 LC/MS control software, Waters will now supply and support additional software which provides full support for the ACQUITY UPLC Systems, including Waters nanoACQUITY UPLC System, on Applied Biosystems/MDS SCIEX's mass spectrometry platforms. The new software from Waters is designed to allow scientists to combine Waters UPLC and Applied Biosystems/MDS SCIEX MS technologies and operate them on a single data system. This new level of compatibility is expected to improve laboratory efficiency.   Niulab enters into marketing tie-up with French firm Niulab Equipment Company, a supplier of analytical and lab equipment to life sciences companies, has entered it an association with France-based Setaram Instrumentation, a manufacturer of advanced thermal analysis equipment and calorimeters, by signing an exclusive distribution agreement to market its products in the country. Setaram Instrumentation not only provides standard instruments, (DTA, DSC, TGA, TMA), advanced thermo-kinetics software AKTS and thermal conductivity mathis instruments, but also has designed specific technologies to open the field of application to a widest range of customer requirement. Setaram Instrumentation provides solutions in different field of applications like petrochemicals, pharmaceuticals, oil, biology, nuclear power, metallurgy, ceramics and polymers.   Simulsorb service Multisorb Technologies, an innovator in sorbent technology, introduced the new SimulSorb service to the Indian pharmaceutical packaging market at the Indian Pharmaceutical Congress 2006 held in Mumbai. The value-added service determines the exact amount of sorbent required protecting packaged pharmaceutical products from various pathways of chemical and physical degradation, helping to enhance drug stability. SimulSorb service is an important part of Multisorb's systems approach, which provides consultation to customers "from calculations through operations."   Alfa Laval divests engineering activity for biopharma industry Alfa Laval, a provider of heat transfer, centrifugal separation and fluid handling, has decided to divest its engineering and validation services for the biopharma industry. The company is divesting this activity through a purchase agreement with the management of this activity. The primary reason for divesting the engineering activity for the biopharm industry, which comprises the offering of engineering and validation services, is the limited connection to Alfa Laval's core business of process solutions and heat transfer, separation and fluid handling products. The divestment is not anticipated to have any negative impact on Alfa Laval's life science activity, a press release said. The release also noted that the turnover of the divested activity is slightly more than MSEK 100 and it employs approximately 110 people. The divestment will cause a non-recurring charge to the profit and loss statement in the fourth quarter 2006 of MSEK 120, of which MSEK 40 are direct costs connected with the divestment. The remaining part is a write-off of goodwill. ]]> <![CDATA[Chromatography Advisor # 4]]> https://biospectrumindia.com/news/95/2052/chromatography-advisor-4.html https://biospectrumindia.com/news/95/2052/chromatography-advisor-4.html Thu, 08 Feb 2007 16:09:00 +0530 New Page 1 Chromatography Advisor # 4 Economic benefits of Protein A alternatives Affinity-based chromatography using Protein A-type sorbents is the "industry standard" for purifying most antibody therapies today. There are several economic challenges with this approach; however Protein A is expensive, has low cleaning tolerances, and a limited lifetime compared to other sorbents. Additionally, elution steps often require highly acidic conditions that can result in substantial antibody aggregation. Several novel chromatography sorbents have proven to be efficient and more cost-effective alternatives to traditional Protein A, and they are giving drug manufacturers some new options to consider. Affinity chromatography on Protein A-based sorbents has been used for more than a generation by drug manufacturers to purify protein-based therapeutics. It is based on the ability of a protein or other biopolymer to bind with a natural or synthetic ligand, and when used in conjunction with other chromatography steps, it provides an effective way of isolating desired antibodies for downstream drug production. It's no secret, however, that Protein A-based sorbents are expensive, and this fact puts pressure on manufacturing to utilize these sorbents in the most efficient manner possible to keep overall production costs under control. The expense is compounded by other factors that limit the usefulness of Protein A-based sorbents. They have low cleaning tolerances compared to chemical-ligand (e.g., ion exchange) sorbents, and the leaching of Protein A fragments during antibody purification remains a significant problem despite attempts to improve engineering. Chemically stable IgG-selective sorbents A different purification approach using two novel sorbents is proving to be an effective alternative for some manufacturers. Both of these sorbents share structural and operational features, however they operate by different chromatographic modes. Carrying a mercaptoethyl-pyridine ligand, MEP HyperCel operates by hydrophobic charge induction chromatography (HCIC), and captures antibodies via a mild hydrophobic interaction and affinity interaction with the immunoglobulin-selective ligand. Carrying a mercaptobenzimidazole-sulfonic acid ligand, MBI HyperCel operates by a "mixed-mode" chromatography and captures antibodies through ionic interaction and molecular recognition on the immunoglobulin-selective ligand. In some applications, the two sorbents may be used effectively in tandem. MEP sorbent was introduced to the market in 1999 and issued a Drug Master File number in 2001. MBI sorbent was released commercially in 2004. Antibody desorption results from a charge repulsion induced by reduction (for MEP ligands) or elevation (for MBI ligands) in the eluant buffer pH. For MEP sorbents antibody binding is achieved with a neutral pH, and desorption is possible by decreasing the pH to a relatively mild 4.0 to 5.5, depending on the pI of the antibody. Because this pH is mild, it reduces aggregate formation and preserves antibody activity. MBI ligands have been engineered for higher pH values, which is useful for antibodies that are sensitive to acidic pH values below 5. The alternative ligand structure can also provide useful, alternative selectivity. In Figure One, the adsorption and desorption mechanisms are illustrated. Figure One Adsorption and Desorption. A neutral or mildly acidic pH at ionic strength typical of cell culture supernatant is used to capture antibodies with MEP and MBI sorbents. Desorption occurs by modulating the pH. In most applications, antibody binding with these ligands is independent of salt concentration, which suggests that typical feedstocks can be loaded onto MEP and MBI sorbents without extensive dilution or diafiltration. For non-antibody proteins, MEP HyperCel may serve as a useful alternative to traditional hydrophobic interaction chromatography (HIC). In such applications binding on MEP HyperCel is typically achieved at significantly lower salt concentrations than those required with traditional HIC sorbents. Increased service lifetime up to 500 percent By some estimates, MEP and MBI ligands offer three to five times longer service life compared to Protein A-based sorbents. The reason for this is the linkage chemistry of Protein A. When exposed to protease-containing feedstocks and to caustic cleaning agents, Protein A sorbents lose their stability. Cleaning validation protocols therefore need to be carefully adjusted to extend their service lifetime, and analytical tests need to be performed to monitor and quantify the levels of protein A fragments that are leached. These fragments must also be effectively removed. Similar to the ligands used for ion exchange sorbents, MEP and MBI sorbents are chemical ligands that remain stable at pH values up to 14, and they an be cleaned regularly with sodium hydroxide solutions at 1M concentrations. They are able to withstand biological feedstocks and the NaOH solutions typically used for Clean-in-Place (CIP) procedures. They also eliminate any danger of protein A leakage. These factors add up to considerable cost-savings and ease-of-use for antibody production. Broad use for a wide variety of biological sources MEP-based sorbents have also proven effective for purifying a wide range of biological streams. While they capture IgG directly from mammalian cell culture supernatants at 95 percent purity, they are also effective for more challenging feedstocks that contain higher levels of impurity proteins, including albumin. Unlike Protein A, they enable binding for IgG variants from different species. Human, rat, goat, sheep, and mouse and even murine IgG1 antibodies can be effectively purified with MEP-based sorbents. Figure Two provides examples of purification rates. When isolating antibody from albumin-containing feedstocks, the IgG fraction isolated on MEP HyperCel can be freed of residual albumin impurity (the principal impurity in examples below) by anion exchange chromatography on DEAE Ceramic HyperD. MBI-based sorbents are also effective in binding human IgG without salt, enabling them to be used at physiological iconic strength to achieve optimal binding with only a minor adjustment of pH. Because binding is possible in an alkaline solution for desorption, acidic-sensitive IgGs are able to preserve their biological activity. Viral clearance has also been studied with these sorbents, with results similar to Protein A. In one example, MEP sorbent was used with minute virus of mice (MVM) in the presence of IgG. A viral clearance reduction of ~ 4 log was reported, equivalent to that of the viral clearance performance of Protein A in the same test. When combined with other orthogonal steps, for example ion exchange, these sorbents can remove virus and host cell protein at levels similar to Protein A, compatible with the requirements for therapeutic-grade IgG purity. The introduction and use of MEP and MBI sorbents in the marketplace has clearly added new options for manufacturers seeking alternatives to Protein A. These products add to a growing list of options and strategies aimed at helping to keep drug processing costs in check. Ian Sellick, Marketing Director, Pall Corporation/BioPharmaceuticals Note: This article has earlier appeared in Bioprocess International.   ]]> <![CDATA["The next 10 years will see diagnostic companies moving towards a more regulated environment"]]> https://biospectrumindia.com/news/95/1786/the-next-10-years-will-see-diagnostic-companies-moving-towards-a-more-regulated-environment.html https://biospectrumindia.com/news/95/1786/the-next-10-years-will-see-diagnostic-companies-moving-towards-a-more-regulated-environment.html Thu, 08 Feb 2007 15:55:00 +0530 New Page 1 "The next 10 years will see diagnostic companies moving towards a more regulated environment" In an interview, Ram Sharma, MD, Becton Dickinson India Pvt Ltd (BD), shares the current focus and the future strategy of the company in the Asian region. What is the current strategy of BD in the life sciences segment for the South Asian region? We are trying to change from a product focus to address the real issues and challenges in the healthcare sector. Challenges such as safe immunization, which is very important for the safety of children, issues like HIV/AIDS diagnosis, care and support, and issues related to diseases like tuberculosis and malaria. Currently, these are the three big diseases, which affect the people all over the world. In terms of corporate philosophy, BD unlike a typical multinational company that caters only to the top level of the society, aims to help all people lead healthy lives. And to do that, we also need to reach to the bottom of the pyramid. In fact, we have some products that are sold exclusively in India, China and the developing regions. Since these products have no relevance in the US or Europe, they are not sold there. We try to make available products/solutions, which are relevant for use in the local markets. In the diagnostics vertical, what is the focus at BD, especially for the Asian markets? In the diagnostics vertical, we are now looking at rapid diagnostics. We would like to make diagnostic products, which are inexpensive, easy-to-use and point-to-point, meaning that they can be taken wherever required. So instead of bringing samples to large testing labs, which is the way it happens in the US and Europe, in India we are looking at an outreach program-instead of bringing the patient to us, can we go to the patient. To accomplish that, we need to have rapid testing, which is simple to use, requires no or minimal training and has no problem in terms of storage. We have actually got a new factory, which is coming up in China, near Shanghai, and it is dedicated for making rapid diagnostics for the developing world. This new facility will take about a year to come up. The advantage at that facility will be that we can make whatever the customer wants since it is a very flexible plant. Our initial focus will be on flu vaccines and diagnostics for a range of infectious diseases like dengue, malaria and HIV. Another area that we are looking at is cultures-liquid and solid cultures. Liquid cultures can be used, for example, in the better detection of tuberculosis and especially in cases of HIV TB co infection. BD is actually getting stronger in diagnostics. We are not only looking at rapid testing, that is just one end of the spectrum, we are also looking at molecular diagnostics which is the high end testing. We already have a presence in molecular diagnostics and now we are further strengthening it. How do you foresee the future of BD in this region? In the next 10 years, our presence will increase dramatically as companies and countries move towards a more regulated environment; Regulated not because there is a need for controlling people, but because therapeutic efficacy and patient safety have gained paramount importance. Soon accreditation like NABL certification will become critical for the company. At that time, our potential will grow tremendously as then we will be able to make our products relevant to everybody and our market share will go up multifold. What are the basic differences between the Western and the Asian diagnostic markets? If you look at the western market, it is largely highly automated. It is automated as there is a very large referral system there. There a lot of samples move into a central referral lab. In India and in South Asia, it is different. Here we have to go to the patient. So the challenge is how to build solutions that bring diagnosis closer to patients rather than the patient moving closer to the lab. The second challenge here is how to evolve an efficient sample transportation system, where the sample is not compromised during transportation. Another critical difference is that labs in the US have a very strong QA/QC system, while in India there is no validation or auditing of labs and there is no accountability. But this is changing now. Recently BD India and the Indian Academy of Pediatricians have signed a MoU for safe injection practices training program. Could you elaborate on this? The Indian Academy of Pediatricians (IAP) is a scientific association and works with companies and the health ministry to suggest better ways of child and mother health. Safe injections and immunization is very important and the IAP has been suggesting a lot of good things in the field of immunization. Since IAP has a large membership of private practitioners, we thought that they will be the ideal candidates to disseminate the message on safe injections and their importance. We are very excited to partner with IAP to promote safe injection practices in India. Rolly Dureha   ]]> <![CDATA[Bangalore Bio 2007 to focus on innovation and growth]]> https://biospectrumindia.com/news/95/2225/bangalore-bio-2007-to-focus-on-innovation-and-growth.html https://biospectrumindia.com/news/95/2225/bangalore-bio-2007-to-focus-on-innovation-and-growth.html Thu, 08 Feb 2007 15:54:00 +0530 New Page 1 Bangalore Bio 2007 to focus on innovation and growth Bangalore Bio 2007, the country's flagship biotech event promoted by the Karnataka government and organized by the Karnataka Vision Group on Biotechnology, will be held from June 7-9, 2007. This year the event is set to be larger than its predecessors, and the focal theme is "Think BIG â€“ Think Biotechnology, Think Innovation and Think Growth." Karnataka's IT and BT secretary, MN Vidyashankar said, "The biotech industry in India today seeks innovative strategies in every aspect of business to meet with the demands of a changing world and forge a place for itself in global market. That's why we have chosen the theme "Think BIG â€“ Think Biotechnology, Think Innovation and Think Growth." This we believe will attract larger participation from the international community. The seventh edition of the exposition would see the participation of over 150 national and international exhibitors. Bangalore Bio-2007 would be a unique platform to bring together experts from biotechnology, pharmaceutical, educational and financial sectors to interact, network, showcase innovations in products and services, he said. Biocon CMD, Kiran Mazumdar Shaw, who is also the chairperson of the Karnataka Vision Group on Biotechnology, said the conference would focus on cutting edge research and innovative product development, biotechnology applications for drug development, IPR issues, patentability of new inventions and regulatory issues and their impact on the industry growth, financing innovations and growth opportunities and bioinformatics and computer applications in biotechnology. Agribiotech Day Agribiotechnology, which had grown by 160 per cent during last year would be given major thrust with June 9 dedicated as Agribiotech Day to showcase India's experience and progress in agribiotechnology. The sessions will address various key issues like public perception of agribiotechnology, challenges of commercializing plant biotechnology products, workable, transparent and science-based regulations for agricultural biotechnology. CEO Conclave The CEO Conclave will witness a high power meeting point of various professionals with key industry stalwarts delivering the "Vision Talk" at the conclave. Poster session This year too, Bangalore Bio will host the poster session in conjunction with the international conference. The objective is to create an exclusive opportunity for young researchers, scientists and technocrats working in universities, R&D labs, various government departments or private sector to share their innovations and research projects, in the areas of biotechnology, agriculture, environment and healthcare and interact with industry top honchos and Indian and global venture capitalists. Posters will be selected based on originality, innovative approach, new ideas and commercial potential. Industry visits In conjunction with the conference, industry visits are being organized for the interested delegates on first-come first serve basis. The delegates will be taken to two core sectors of biotechnology-biopharma and agribio. The industry visit would include company presentation, management (general and specific techniques), innovation, business processes, cGMP, health and safety and more.   ]]> <![CDATA[DBT to shepherd India Pavilion at BOSTON BIO]]> https://biospectrumindia.com/news/95/6211/dbt-to-shepherd-india-pavilion-at-boston-bio.html https://biospectrumindia.com/news/95/6211/dbt-to-shepherd-india-pavilion-at-boston-bio.html Thu, 08 Feb 2007 15:49:00 +0530 New Page 1 DBT to shepherd India Pavilion at BOSTON BIO India is gearing up in a big way for the annual convention of BIO (Biotechnology Industry Association, USA) 2007, which will be held from May 6-9, 2007 in Boston, MA. The Confederation of Indian Industry (CII) in partnership with the department of biotechnology (DBT) and ABLE as a sectoral partner is organizing the India Pavilion at BIO 2007, the biggest biotech show of the year. Compared with the fragmented individual efforts made the various stakeholders last year, this time the convention will see a consolidated Indian presence. Concerted efforts have already started for showcasing the Indian life sciences strength and opportunities under one umbrella. Moreover, this year, the Indian pavilion will be bigger and better, at par with that of the many other participating countries. The CII has secured a 4,400 sft prime location, almost four times the space as compared to last year, for the pavilion this year. In addition, the India Pavilion will see an increased participation of the small and medium companies (SMEs) and entrepreneurs from the biotech and life sciences space in the country. In order to promote the SMEs at the convention, the DBT has partnered with CII so that the participation cost is subsidized for this sector. Commenting on the preparations for the event, Dr MK Bhan, secretary, DBT, said, "India's participation at BIO 2007 should be consolidated and on a bigger scale. We need to connect with the delegations of other countries more proactively and with quality. So we are using our influence in the different knowledge circles to come up with our best effort. We are also linking with the international programs of the Science Ministry. The idea is to connect the efforts of the Council of Scientific and Industrial Research (CSIR), Department of Science and Technology (DST) and DBT with that of the industry organizations like the CII, ABLE, and FICCI so that there is more cohesion on an international platform." Acknowledging the thrust on the small and medium companies this year, he added, "There is a concerted effort to promote and encourage more medium companies and SMEs to participate at BIO. We are working with them to be there in a sizable number." CII will also coordinate a Biotechnology Mission to the US to meet select companies on May 3 and 4, 2007 in Massachusetts and Washington DC. Kapil Sibal, Union minister of science and technology and earth sciences will be the chief mission patron, accompanied by Dr MK Bhan along with other senior industry and government delegates. The India Pavilion will provide an opportunity to generate business leads for companies and help India to promote itself as a biotechnology destination. Some important features at the pavilion will be the focus on the Indian life sciences industry and government's facilitating role; India focused International seminars; Bilateral and one to one meetings. The BIO convention is the largest gathering of biotechnology leaders in the world, attracting more than 18,000 participants, featuring over 190 sessions, almost 1000 speakers, 17,6,000 sft area, 60 pavilions and over 1,700 exhibitors. ]]> <![CDATA[Biotech education and career avenues]]> https://biospectrumindia.com/news/95/8358/biotech-education-and-career-avenues.html https://biospectrumindia.com/news/95/8358/biotech-education-and-career-avenues.html Thu, 08 Feb 2007 15:41:00 +0530 New Page 1 Biotech education and career avenues Dr Suman Govil and Shubhlata Sharma elaborate on the DBT's efforts in generating skilled manpower in the biotech arena along with the job openings and scope that the segment offers. The Government of India started a multi-agency National Biotechnology Board comprising the UGC, ICMR, CSIR and DST in 1982, which was upgraded to a full-fledged department in 1986 to give the much-desired impetus to this area. India can take pride in being one of the first few countries in the world to initiate an integrated program of human resource development in biotechnology comprising post graduate teaching programs, short-term training courses for upgrading skills of mid-career scientists, faculty involved in undergraduate and post graduate teaching, training in leading overseas laboratories, in gap areas where expertise does not exist in the country. The department took a well-informed decision not to start undergraduate teaching in biotechnology, as it is a highly specialized, laboratory-intensive course. The post graduate courses were initiated in 1985 in six universities in close collaboration with the University Grants Commission, ICAR and the Department of Ocean Development. These programs were conceived as collaborative, inter-departmental and inter-institutional programs and initiated on the basis of core strength in the area of faculty, existing infrastructural facilities, R&D grants on competitive funding basis and nearby institutions engaged in biotechnology R&D. India is a vast country and keeping in mind, the demand for trained manpower in specific areas and regional aspirations, these programs have been expanded in over 61 universities in general, medical, agricultural, marine, veterinary, industrial and pharmaceutical biotechnology. The department is considering initiating new programs in food and nutrition, clinical pharmacology and product development, bio-instruments and biomedical standards, bioenterprise management and financing and regulatory affairs. Curricula: To maintain uniformity and minimum standards of education, model course curricula have been developed by organizing brainstorming sessions. To keep abreast with the latest developments in the rapidly advancing area of biotechnology, faculty up gradation programs in leading national laboratories with emphasis on hands-on training have been developed for college teachers involved in undergraduate education and faculty associated with postgraduate teaching. There is a provision for training in overseas laboratories also. These teaching programs are continuously monitored by an in-house advisory committee with outside expert members from academia and industry and DBT representative, annual meeting of course coordinators and DBTâ€“UGC joint task force on HRD to ensure minimum and uniform teaching standards. Admission procedure: To compete in the global market for jobs, it is important to select bright and meritorious candidates and impart best training. The selection of students is made on an all India basis through Common Entrance Test (CET), joint entrance test conducted by IIT or tests conducted by respective universities. The courses are very popular and admission procedure is highly stringent which is evident from the fact that approximately 21,000 students competed for 428 seats of MSc General Biotechnology in the JNU Common Entrance Test during 2006-07. Placement analysis: The success of a teaching program is primarily judged by the quality of education imparted and placement of students passing out. These programs have flourished as students coming out of these programs qualify in UGC-CSIR National Entrance Test (NET) for Junior Research Fellowship (JRF), DBT Biotechnology eligibility test (BET) for JRF and are pursuing research in leading laboratories in the country like the TIFR, BARC, IISc, NII, CCMB and JNU. A number of students find placement in leading industries such as Biocon, Dr Reddy's Laboratories, Shantha Biotech, Panacea, Advanced Enzyme Technology, Bharat Serum, Intas Pharmaceuticals, Serum Institute, US Vitamins, Wockhardt and Zydus Cadila Pharmaceuticals. The analysis of the first placement of approximately 1000 students produced during 1985 -1995 shows 54 percent students opt for PhD within the country, almost ¼th students opt for jobs in research, teaching and industry. The analysis of 2000 students produced during the last five years depicts almost similar trend. However, percentage of students working in industry has increased from 12 to 17. As expected, MSc general, agricultural, medical, marine biotechnology students prefer PhD while MTech students (almost half) join industries. Industrial training: Prominent industry leaders and HR experts feel that it is difficult to find the right candidates as the skill sets of manpower produced by academic institutions often do not match the requirements of the ever competitive biotechnology industry. This could be due to a big gap between the knowledge imparted vis a vis knowledge required by the industry. Finding the right people for the job is the immediate challenge faced by the industry, as the industry finds it difficult to invest in in-service training of hired candidates. To bridge this gap, the Department of Biotechnology is facilitating practical exposure to biotechnology postgraduates for a period of six months in the industry. This program is mutually beneficial to the students and industry. Industrial exposure orients students to the needs of the industry increasing their acceptability and also provides an opportunity to the companies to assess their performance. This program has completed 15 years and has become increasingly popular among students and industries as is evident from increase in number of applicants and number of selected candidates. The number of industries offering this training has also steadily grown. Several leading biotechnology companies like Monsanto, Workhardt, Aurigene Discovery Technologies, Gangagen Biotech, Lifecare Innovations, Dabur, Dr Reddy's Lab, Panacea Biotech, JK Agrigenetics, Auroprobe Labs, Nicholas Piramal, Jubilant Biosys, Pepsi Foods, Pepsico Holdings, ABL Biotech Ltd and Mahyco have offered training to the students. This industrial training has facilitated in permanent placement of students in the industry with a success rate of approximately 25 percent. Some of the industries who have absorbed trainees are Lifecare Innovations, Unique Biotech Ltd, Century Seeds, Sangene Biotech and Shantha Biotechnics, Dabur, Jubilant Biosys, Gangagen Biotechnologies and Monsanto. Career opportunities: Biotechnology has applications in all spheres of human and animal life such as food and nutritional sufficiency, health, crime investigation and forensic science, environmentally sustainable development. Predictions of IT-BT led boom in the coming years resulted in hype with hope for creation of a number of jobs in the coming years. This has led to mushrooming of a large number of private and public sector institutions conducting self-financing degree courses in biotechnology both at undergraduate and postgraduate levels. This expansion has led to a general deterioration in quality of manpower, which is a major concern with producers, as well as employers of manpower. The need for accreditation of institutes offering teaching programs has never been felt so strongly before. Opportunities for biotechnology students exist in agri-based industries involved in production of transgenic plants, seed industries, tissue culture units, agri chemicals such as biofertilisers and biopesticides, environmental amelioration, pharma industries for diagnostics, vaccines, new drug molecules, clinical research organizations and bioinformatics industry. Opportunities exist in research and development, production and manufacturing, quality control and analysis, technology transfer and management knowledge-based marketing, setting up of new enterprises, consultancy organizations for preparation of techno economic feasibility reports, regulatory affairs such as toxicology, environment health and safety, biosafety, patent attorneys and examiners for IPR. The jobs for marketing are 20 times more in number as compared to R&D as well as more monetarily rewarding. With India becoming a signatory to GATT, a sudden spurt in filing of patents as well as dispute settlement cases has been witnessed resulting in the creation of tremendous opportunities for patent attorneys and examiners. In addition to the industry, opportunities for science management, teaching and R&D jobs exist in public and private sector teaching and R&D institutions.   Shubhlata Sharma is a senior scientific officer at DBT and Dr Suman Govil is advisor, DBT, Ministry of Science & Technology. Note: The views expressed in this article are those of the authors and not necessarily of the organization to which they belong. Note: This is a summary of the comprehensive article published in the January 2007 issue of BioSpectrum. The complete list of DBT programs is available online.   ]]> <![CDATA[Biotech IPOs in 2007]]> https://biospectrumindia.com/news/95/2941/biotech-ipos-in-2007.html https://biospectrumindia.com/news/95/2941/biotech-ipos-in-2007.html Thu, 08 Feb 2007 15:29:00 +0530 New Page 1 Biotech IPOs in 2007 The biotech industry in the last few years has been growing between 35 and 40 percent. However, there have been hardly any major IPOs after Biocon's listing in 2005. This year and the next one could see several players taking the IPO route. Hyderabad-based Celestial Labs and Bangalore-based Avesthagen have confirmed that they would be going for an IPO. Celestial Labs Limited, an ISO 9001 company, is based in Hyderabad and has been providing IT/bioinformatics services to the life science, pharma companies, hospitals and research institutions for the last nine years. It provides customized enterprise resource planning, database solutions and other bioservices. Dr AN Singh, managing director, Celestial Labs Ltd.           Dr Villoo Morawala-Patell, vice- chairperson and MD, Avesthagen Celestial, by leveraging the software and bioinformatics skills and domain expertise in biopharmaceuticals arena, has developed a Denovo drug design tool with the main objective of developing new drug molecules in three to five years in place of the normally 15 years taken by traditional methods. The development of this tool has been appraised and funded by DSIR (department of science and industrial research, ministry of science and technology, Government of India). Celestial has collaboration with prestigious CSIR Institute like IMTECH (Institute of Microbial Technology) Chandigarh and CCMB (Centre for Cellular and Microbial Biology), Hyderabad, where all its developmental activities are validated. Development work for vitiligo and anti-cancer drug molecules is under progress at CCMB Celestial has developed a commercial portal called www. Sanjivani.biz. The main objective is to transact business of about 100-plants based therapeutic products taken initially from all over India. Celestial has prepared a plant based formulation in capsule form for oral application to complement the vitiligo Bio drug molecule being developed for topical application. Celestial has selected the valuable medicinal plants which are on the verge of becoming extinct and will adopt tissue culture methods to preserve and prepare the quality raw material. Celestial has already filed applications for obtaining five Indian patents (Tools and New drugs). Celestial's overall project of Rs 40 crore has been apprised and term loan participation to the tune of Rs two crore from Punjab National Bank. Further there is appraisal and term loan participation from the DSIR and Technology Development Board, ministry of science and technology, to the tune of Rs 5.65 crore. The company plans to raise Rs 30 crore through an IPO. This to scale up its ERP services offerings and manpower and scale up its operation in the US and European countries. The IPO money will also be used to set up the manufacturing facilities for industrial biotech (enzymes) products like Alpha Amylase and Alkaline Protease which have a very huge market in India and market them in India and abroad. India still imports about 70 percent of these requirements. "We have a plan to infuse some enzyme for medicinal use which acts like a catalyst to enhance the activities. Celestial has already signed an agreement for technology transfer of enzymes with CSIR Institute, IMTECH Chandigarh and setting up the manufacturing facility at Genome Valley of Andhra Pradesh. The project has been apprised and being funded by the Technology Development Board, ministry of science and technology," said Dr AN Singh, managing director, Celestial Labs Ltd. The IPO proceedings will also be used to scale up the new drug development process. The company has already started screening new molecules. Drug molecule for treatment of Vitiligo has already been cloned and purified and will be formulating further three drugs for antiwrinkles, accelerated wound healing and also to provide natural tan in the body. Celestial is optimizing the processes and resources to integrate the bioinformatics and bio pharmaceuticals which offer huge potential. The company has made modest revenue of Rs 10.20 crore with a profit margin of Rs 3.28 crore from services offerings and is confident to make substantial jump in the coming years from enzymes and licensing dug molecules apart from increasing revenues in services. Celestial expects to reach a turnover of Rs 15 crore by March 2007. Celestial proposes to open the issue by March 2007. Avestha Gengraine Technologies Pvt Ltd, a fully integrated life sciences company, which recently announced the successful closure of its Series 'C' fundraise totaling Rs 145 crore in equity investments, has started preparations for its IPO which is scheduled to take place by mid 2008, around which time the commercial launch of the first products is expected for the bio-nutritional and bio-pharmaceutical product pipelines. The headcount of the company is anticipated to increase to over 600 within the next 18 months. The company's revenues in 2006-07 are expected to reach Rs 35-40 crore. Its turnover in 2005-06 was Rs 18 crore.   ]]> <![CDATA["We will be a diverse and integrated global life sciences company in five years"]]> https://biospectrumindia.com/news/95/1710/we-will-be-a-diverse-and-integrated-global-life-sciences-company-in-five-years.html https://biospectrumindia.com/news/95/1710/we-will-be-a-diverse-and-integrated-global-life-sciences-company-in-five-years.html Thu, 08 Feb 2007 15:14:00 +0530 New Page 1 "We will be a diverse and integrated global life sciences company in five years" -KV Subramaniam, president, Reliance Life Sciences KV Subramaniam, president and CEO of Reliance Life Sciences, a research-led, biotechnology driven initiative of the Reliance Group of Companies, has been instrumental in conceiving and developing the Reliance Life Sciences, which has several programs covering stem cells and tissue engineering, molecular diagnostics and genetics, therapeutic proteins, biopolymers, biofuels, biochemicals, plant biotechnology, clinical research and contract research. A chemical engineer from Madras University and a management graduate from the Indian Institute of Management, Ahmedabad, and also qualified to be a chartered financial analyst, Subramaniam started his career with Indian Petrochemicals Corporation, where he spent 14 years in several functions. Before taking up the responsibility of developing Reliance Life Sciences in 2001, he was with Reliance Industries Ltd from 1994 to lead the corporate business development function, where he was involved in several new initiatives of the organization in petrochemicals, power, infrastructure, agriculture and insurance. In an exclusive interview with BioSpectrum, KV Subramaniam spoke about how Reliance Life Sciences came into existence and the company's future plans. What made biotechnology an attractive venture for Reliance Industries to invest in 2001? Reliance Industries Limited (RIL) had attained a level of global position in its polyester, petrochemicals, and fuels businesses. Mukesh Ambani wanted an answer as to what would undermine the traditional position of Reliance in these businesses. The answer was in industrial biotechnology. When we did a detailed analysis, we realized that the opportunities in medical and plant biotechnology wee compelling. Thus, we decided to develop a broad-based life sciences initiative covering all these three areas. What were the hurdles Reliance Life Sciences faced during one initial phase? And what are the present hurdles (like HR issues, regulatory, sourcing raw materials etc) it is facing now? Our initial focus was on developing basic competencies and basic infrastructure. We decided to develop a broad-based initiative covering stem cells, tissue engineering, therapeutic proteins, molecular diagnostics and genetics, plant tissue culture, plant metabolic engineering, biopolymers, biofuels, biochemicals and clinical research. Acquiring and developing competencies in all these areas was the major challenge. Today competency development continues to be a challenge. We have made significant investments in competency development programs. As far as regulation is concerned, it is by and large conducive to the development of various biotechnology sectors. We recognize that life sciences, particularly on the medical biotechnology side, is highly regulated and it is an imperative to conform to international standards. Right from the beginning, our work has been consistent with international standards, GLP, GCP, GMP, GAMP etc. We are building facilities that are compliant with US FDA and EMEA standards. Unlike other biotechnology companies, Reliance Life Sciences (RLS) since its inception has been focusing on all areas of biotechnology like plant, medical, recombinant, clinical research, industrial biotech and biofuels. Of these, which is the focuse area for RLS, where it is pumping in more resources to reap maximum benefits? Of all the areas that we are engaged with, biopharmaceuticals is a dominant one, from the point of view of investments, people and product range. What is the present headcount of RLS including the R&D and sales/marketing? At present RLS has a workforce of more than 700 people. We will be growing to a strength of around 2,000 people in a couple of years. Of late, we have been adding resources in clinical research and business development areas. Since human capital is a key factor for growth in the knowledge intense industry like biotechnology, what strategy has the RLS taken to retain the best talents? Talent acquisition at Reliance Life Sciences is at two levels-having expats and developing competencies at entry levels. Globally there is a talent constraint in the biotechnology industry, and more so in India. We have hired some expat resources at senior levels and we are running a number of competency development programs for meeting our talent requirements. Attrition is an issue in the industry. Typically, clinical research has a higher rate of attrition. In case of R&D, the attrition rates are much less. RLS addresses attrition issues by providing people with more challenging opportunities. We also have a retention structure in our compensation policies. Original seed of thought "The rapid growth of biotechnology will also open up several avenues for creation of wealth. One indication of this is the estimate that the global biotechnology market will grow by about $100 billion in the next five years. Although this is small in comparison to the global GDP of $30 trillion, it signals that the race has started. I, for one, would envisage that biotechnology would grow into a trillion dollar industry in 10 to 15 years. Biotechnology would help open up a completely new segment of the geriatric market comprising people who are above the age of 60. Today, this market is very small, but in the future it would be substantial. People beyond the age of 60 would be productive income earners. The old mindset of retirement at the age of 58, as we have in India, would no longer be relevant. Biotechnology would also see the emergence of such domains as nutraceuticals, individualized medicine, regenerative medicine, and new classes of drugs. Each of these domains will represent large market opportunities, as they would touch the life of every person who inhabits the world. To sum up, biotechnology will substantially alter the quality of life, the form of life and the duration of life. It would promote new opportunities for creation of wealth." An excerpt from a speech delivered by Mukesh Ambani, chairman and managing director, Reliance Industries Ltd at the third S.S. Nadkarni Memorial Lecture on "Technology in a Changing World" held on May 16, 2001 which actually became the original seed of thought in setting up Reliance Life Sciences. At what rate is RLS growing? And what is its present financial status? What are the investments made in R&D activities in RLS? Being a private limited company, we do not talk about our financials. I can at best say that investments run into several hundred crores and revenues are growing at three digit rates. After signing a recent deal with GeneMedix for acquiring its 74 percent stake, what is your new strategy for growth? Are you looking at more acquisitions for the growth of the company? Reliance is substantially driven by the philosophy of building businesses from scratch. Once we build the business to some scale, only then do we look at acquisitions. This is because you need management depth and the right business perspectives to evaluate, acquire and integrate acquisition opportunities. Initially, we will be looking at small acquisitions. We will focus on doing them well and then look at larger acquisitions. RLS is expected to launch about eight new products this year in India. Can we expect the availability of these new products at an affordable price like the plasma proteins that were made available at 30-40 percent cheaper over the international price in India in 2005? RLS products will be available at affordable prices. Our prices are very competitive in comparison to international prices. However, in some of these products like stem cell therapy, there is no benchmark. Initially, we will have biosimilars, some stem cell therapies and plasma proteins. In 2-3 years time, we will have monoclonal antibodies, novel proteins, and siRNA molecules. How would RLS compensate the profit margins while offering its products at an affordable price? Across Reliance, a lot of emphasis is laid on being very competitive internationally. Our R&D, as well as discovery and development chain is highly competitive. We have, so far, developed all products in-house. Therefore, we have an inherent advantage. We also do a lot of clinical trials in-house. Our manufacturing plants are being created at much lower costs as compared to global biopharma manufacturing facilities. We will first focus on the Indian market and subsequently take our products to overseas markets. What business model has RLS adopted for its current growth in the life sciences space? There are essentially four businesses we are looking at. In our biopharmaceuticals business, we are taking an integrated global view. In terms of the biopharmaceuticals facility, we have a pilot scale facility in Central Mumbai for plasma proteins and recombinant proteins. At Dhirubhai Ambani Life Sciences Centre, we are building three commercial scale facilities for biopharmaceuticals manufacturing and these will be commissioned in a span of one year. In services, our approach is to become a global clinical research service provider, ranging from pre-clinical research, Phase 1, Phase 2, Phase 3, Phase 4, clinical data management, biostatistics and bio-availability/bio-equivalence. Our biofuels initiative is focused on developing products, which can be blended with transportation fuels and which are competitive with conventional hydrocarbon based fuels. Considering the growth of the biotechnology industry, where do you see RLS in the next five years? The first five years were devoted to developing programs, developing basic competencies and creating basic infrastructure. In the next five years, we will be building a substantial manufacturing base, getting a number of products to the marketplace and implementing a global business footprint. While in the last five years we were India-centric, in the next five years, we will be a diverse and integrated global life sciences company. n   ]]> <![CDATA[Biopartnering is Advinus mantra for success]]> https://biospectrumindia.com/news/95/1336/biopartnering-is-advinus-mantra-for-success.html https://biospectrumindia.com/news/95/1336/biopartnering-is-advinus-mantra-for-success.html Thu, 08 Feb 2007 14:54:00 +0530 New Page 1 Biopartnering is Advinus mantra for success Advinus Therapeutics is exploring opportunities in companies based in the US and Europe, which are looking at cost-effective, high-quality solutions for their R&D programs. Advinus Therapeutics was set up as a venture between the Tata Group and Dr Rashmi Barbhaiya, the former head of research at Ranbaxy. After his return to India following a long stint in the US as a researcher for drug maker Bristol-Myers Squibb and later at Ranbaxy's in New Delhi, Dr Barbhaiya was looking to run his own show when he found a backer in the Tatas, who were keen on developing businesses in the knowledge sector. They were looking for someone to turn a small agrochemical laboratory in Bangalore into a center for clinical research. Dr Barbhaiya agreed to run the Bangalore facility, but he also wanted funding for a modern drug discovery lab. The result was Advinus Therapeutics, a company whose new drug research is powered by Indian scientists returning from the US and other countries. The name Advinus is shorthand for "Advantage India US", says Dr Barbhaiya. Truly so it is. Focused on new drug discovery and development of pharmaceutical and agrochemical products, Advinus Therapeutics is promoted by the Tatas, with total revenues of more than $17 billion and a market capitalization of more than $31 billion. Dr Barbhaiya, who is a co-promoter with a smaller stake, is the CEO and managing director of the company. Advinus is uniquely focused on pharmaceutical R&D with no generics or API focus. The discovery arm of Advinus located in Pune, focuses on metabolic diseases, inflammation and neglected diseases. The unit is fully integrated from hit to preclinical candidate. "Our presence in India helps us enhance the productivity and efficiency of our agrochemical and pharmaceutical R&D programs to unprecedented levels of cost-effectiveness and quality by bringing together demonstrated world class expertise with the talent and economies of India," says Dr Barbhaiya. Advinus' development unit offers an integrated service platform for process chemistry, DMPK, clinical pharmacology, safety assessment, analytical R&D, bioanalytical and formulation development. Advinus Therapeutics is already being recognized at a global level. Last year, it was named as India's best emerging CRO in drug discovery services, according to a survey conducted by Proximare, a management consulting firm based in New Jersey that exclusively serves pharmaceutical and biotechnology companies with strategic issues. The company is exploring opportunities in companies based in the US and Europe which are looking at cost-effective, high-quality solutions for their R&D programs. One such collaboration occurred in November 2006. Advinus and Merck & Co., Inc. formed a drug discovery and clinical development collaboration in the area of metabolic disorders to work together to develop clinically validated drug candidates for metabolic disorders. In another initiative last November, Advinus forged an alliance with Ahmedabad-based Veeda CR to leverage each other's capabilities to create an integrated drug discovery through phase II platform. The alliance offered packages involving preclinical and early clinical development, animal and human safety pharmacology, preclinical toxicology and pharmacology, clinical pharmacology as also microdosing capabilities to pick drug candidates on the basis of human PK data. The alliance seeks to leverage Veeda's biomarkers capabilities for preclinical and clinical applications. This tie-up has set new precedence in the emerging drug discovery industry in the country and will attract companies looking for preclinical and clinical services in the European and American geographies. With the return of Dr Rashmi Barbhaiya with years of US experience in drug discovery and development, the Indian pharmaceuticals business has indeed received a shot in the arm. Namratha Jagtap   ]]> <![CDATA[Nanotech, biotech spur anti-cancer drugs]]> https://biospectrumindia.com/news/95/4873/nanotech-biotech-spur-anti-cancer-drugs.html https://biospectrumindia.com/news/95/4873/nanotech-biotech-spur-anti-cancer-drugs.html Thu, 08 Feb 2007 14:37:00 +0530 New Page 1 Nanotech, biotech spur anti-cancer drugs Each year more than 10 million people worldwide are diagnosed with cancer, another 24 million people live with cancer being diagnosed in the last five years and every year 6.7 million people worldwide die from cancer. These bleak statistics show an enormous demand for new anti-cancer therapeutics. And pharma companies are rising up to the challenge. The past few years have seen a spurt of activity in the oncology space globally and in India as well. Though generic drugs have been a ready cash generator till now, immense competition in the generic space has led to price erosion making the field less attractive. The future of the anti-cancer segment lies in new drug discovery. As a result, many pharma companies have realigned their priorities, forged partnerships, and initiated proprietary R&D. Within the country itself, a number of cancer and related drugs were launched during the past one year. There is a rush between the companies to capture a part of the over Rs 1,000-crore oncology market in India. Dabur, Biocon, Cadila, Nicholas, Merck and Lilly have been some of the front-runners in this segment. In the first week of January 2007, Dabur Pharma launched Nanoxel, a new version of an existing anti-cancer drug Paclitaxel, which is a nanoparticle-based formulation. The good news for patients is that the new drug can be delivered in higher doses while reducing side effects associated with chemotherapy. The generic anti-cancer drug paclitaxel is not usually soluble in water or blood, and so must be administered to patients in a castor oil-based solvent called cremophor that itself can cause dangerous side effects. To circumvent the problem, DRF (Dabur Research Foundation, which spearheads the R&D activity of the company) used nanotechnology to create Nanoxel, a water-soluble version of paclitaxel that can be absorbed into a patient's bloodstream without using toxic cremophor. According to Dr Anand Burman, chairman, Dabur Pharma, "This is the first commercial application of nanotechnology in the Indian market and the pharma sector outside the US". The only other comparable non-cremophor-based version of Paclitaxel is the more expensive Abraxane, made and marketed in the US. Paclitaxel belongs to a class of drugs called anti-neoplastics that interfere with the growth of cancerous tumors in certain kinds of breast, lung and ovarian cancers, as well as other forms of cancer. Dabur holds a global patent for this new drug delivery system. The company hopes to get permission to market the drug delivery system in both the US and European Union within 18 to 36 months, and is about to begin international trials. The market for the blockbuster drug Paclitaxel worldwide is estimated to be just under $1 billion making Dabur upbeat about not only the future of Nanoxel drug but the new drug delivery platform as well. "Within the country, the market size of Paclitaxel, in terms of amount required, is 8-11 kgs. We hope that Nanoxel will replace the conventional Paclitaxel slowly and in about 10 years the regular Paclitaxel will disappear," said Dr Burman. Dabur has always been a trailblazer in the oncology arena. Way back in 1994, it became one of only two companies worldwide to launch the anti-cancer drug Intaxel (Paclitaxel). It was the first company in the world to isolate the anticancer drug, Paclitaxel, from the leaves of Himalayan Yew Tree using a unique eco-friendly process, which facilitated manufacture of cheaper anti-cancer medicines. In 2001, with the setting up of Dabur Oncology's sterile cytotoxic facility, the company gained entry into the highly specialized area of cancer therapy. Currently, its new chemical entity DRF-7295, a peptide based anti-cancer drug is in Phase II clinical trials and has shown promising results. In addition to peptide molecules, the company is also working on small organic synthetic molecules, phytochemical molecules and potential cancer therapeutic vaccines. Besides Dabur, there are several other companies in the country, which are active in the oncology segment. According to oncologists, next to cardiology, cancer is responsible for the maximum mortality. Now with sophisticated research techniques available, most of the companies want to focus on anti-cancer therapies not only for India but the world over. They are keen to capture a share in the international market, which is expected to touch $64 billion by 2010. In September 2006, Biocon, another company with a long-term focus on cancer therapeutics, launched an anti-cancer drug, Biomab-EGFR, in the country. This marks the company's entry into proprietary immunotherapeutics. The drug is based on a therapeutic antibody and is the first of the eight MAb products being jointly developed by Biocon and its Cuban research partner, CIMAB. The antibody is rigged to target cancer of head and neck in which the sub-continent has 30 percent of the global incidence. Biocon would take up trials soon for other cancers such as lung, colorectal, breast among others. The company has set up a new oncotherapeutics division to handle its upcoming products. September 2006 also saw the partnership between ClinTec International, a full service global clinical research organization headquartered in the UK and Dr Reddy's Laboratories for the co-development of anti-cancer drug, DRF 1042. This drug belongs to the topoisomerase inhibitors class of compounds and has shown potential in the treatment of various types of cancer in patients. Dr Reddy's has successfully completed Phase I clinical trials for DRF 1042 in India. ClinTec International will lead the clinical development of DRF 1042 including undertaking all regulatory work with the aim of securing USFDA and EMEA approvals as fast as possible. Currently, the phase II clinical trials of the drug are being planned in Europe. Meanwhile, Cadila Pahrmaceuticals, a Rs 650-crore pharma company, has started the groundwork to launch its anti-cancer therapeutic vaccine, Immuvac, in the US. The move could make it the first Indian drug company to introduce an original Indian pharmaceutical product in the US. Till now, the drugs launched by Indian companies in the US and other countries have been generic versions of pharma products. The firm has got USFDA approval to begin trials there and plans to out-license the vaccine to a US firm. In the US, Cadila is looking at human clinical trials for cancer and tuberculosis. The company has submitted the investigational new drug requirements for Immuvac. The launch may come about only in late 2008 as the trials are expected to go on for at least 12 to 18 months. Immuvac was initially developed as an anti-leprosy vaccine by the National Institute of Immunology, New Delhi, and the technology was transferred to Cadila. The R&D team at Cadila carried out more research and found the vaccine to be efficacious against some types of cancers like non-small cell lung cancer, prostrate cancer, bladder cancer and melanoma as well as Tuberculosis. Marking the entry of Serum Institute of India in this sector was its tie-up with Chicago-based Akorn Inc last year. This is a 15-year tie-up for the development of anti-cancer and biological products. The manufacture of these products would begin at the new special economic zone of SIIL by end of December 2007. Initially, some generic products would be manufactured and would be available in the markets by end of 2009 and later the facility would also look at the production of specific products with intellectual property, which would happen in about five years. Earlier in October 2004, Akorn and Serum had entered into an exclusive drug development and distribution agreement for oncology and other injectible products. Another Indian pharmaceutical giant, Nicholas Piramal, has its prospective anti-cancer drug molecule in clinical studies being carried out in Canada and India. The prospective cancer drug molecule is the first in a series of compounds from the company's research centre to enter into clinical trials. It is an inhibitor of a key protein that is required by the cells to divide. Based on the initial laboratory data, P276-00 appears suitable as an agent to treat lung, breast and colon cancers. If all goes well, the company expects the cancer drug to hit the market by 2008. Subsequently, in late 2006, Nicholas has signed an agreement with Morvus Technology, a UK-based drug discovery company, encompassing a combination therapy for cancer, which utilizes a specific Cyclin Dependent Kinase inhibitor to enhance the effectiveness of known anti-cancer drugs. While, Merck Specialties, the Indian subsidiary of Merck KGaA, has announced the introduction of Erbitux, a new gold standard targeted therapy for the treatment of Colorectal Cancer (CRC) in India in August 2006. Erbitux, which has already obtained approval for the treatment of CRC in 53 countries works by targeting the Epidermal Growth Factor Receptor (EGFR) which is found on the surface of cells and is involved in the stimulation of cellular growth, replication and/or differentiation when stimulated by growth factors. EGFR has been shown to be involved in the development and progression of many common types of cancers. Subsequently Merck received approval from the Drug Controller General of India (DCGI) for a second indication-for the treatment of patients with locally advanced squamous cell carcinoma of the head and neck (SCCHN). Now Erbitux is also indicated for use in combination with radiation therapy for the treatment of locally or regionally advanced SCCHN. Close on the heels of the launch by Merck, Eli Lilly launched Alimta for the treatment of patients with malignant pleural mesothelioma (MPM)-a rare type of cancer that has strong correlation with exposure to asbestos. Alimta has also been approved as second line treatment for non small-cell lung cancer. Also vying for presence in the Rs 1000-crore oncology market is Zenotech Labs, which will start marketing one generic oncology drug each of Novartis and Amgen/Roche. AstraZeneca Pharma India also expects to be a dominant player in cancer therapeutics in the country by 2008. It has five of the parent's seven oncology brands and is conducting trials before bringing in some more. Earlier in 2002, Wockhardt introduced a 10,000 iu (international unit) per day version of recombinant erythropoietin, 'Wepox' in the oncology space. The other players in the erythropoietin market include Johnson & Johnson, Zydus Cadila, Nicholas Piramal, Hindustan Antibiotics, Emcure and LG of South Korea. According to Dr SK Advani, a well-known oncologist, "Next to cardiology, cancer is responsible for the most mortality. India has a high incidence of one million cancer cases a year. There is a need for more targeted treatment. All of us are trying to introduce relatively patient friendly drugs and change this area from an area of fear to that of hope." Rolly Dureha   ]]> <![CDATA["Gujarat has a strong network to support the growth of biotechnology"]]> https://biospectrumindia.com/news/95/2019/gujarat-has-a-strong-network-to-support-the-growth-of-biotechnology.html https://biospectrumindia.com/news/95/2019/gujarat-has-a-strong-network-to-support-the-growth-of-biotechnology.html Thu, 08 Feb 2007 14:35:00 +0530 New Page 1 "Gujarat has a strong network to support the growth of biotechnology" Dr Manju Sharma stresses on public-private partnership "Gujarat has a network of academic institutions, knowledge-based scientific support and also good administration, which will support the growth of the biotechnology industry in the state," said Dr Manju Sharma, principal advisor, biotechnology, Government of Gujarat and former secretary, department of biotechnology (DBT). She was speaking at the biotechnology session in Vibrant Gujarat 2007, a global investors summit organized by the Gujarat government on January 13, 2007 at Ahmedabad. Dr Manju Sharma said, "Biotechnology is a focused area for economic growth for any country. Like Information Technology, the government has given equal importance to bioinformatics and set up bioinformatics centers across the country. Besides, measures were taken in the last 15 years in developing human resources and setting up infrastructure for the same. However, still there are some concerns related to acceptance of GM technology, bio-safety guidelines, and regulatory procedures. To overcome the issues in biotechnology, we have to strengthen the public-private partnership by bringing all stakeholders-scientists, academicians and industry people on a single platform." Dr Ute Stolzle, vice president of Genezyme, sharing her thoughts on "Influence of biotechnology on public healthcare system in the coming future," said, "Genezyme is intended to work with the government of Gujarat in enzyme replacement therapy in Gaucher's Disease, which is the most prevalent lysosomal storage disease due to deficiency of glucocerebrosidase (GCR) activity with secondary accumulation of GCR within the lysosomes of macrophages." Dr KO Isaac, chairman and managing director, ABL Biotechnologies, elaborating on the opportunities in marine biotechnology, said, "Gujarat has a lot of potential to offer to the pharma industry because of the availability of huge marine resources at its coastline. Initiatives in research and development in marine biotechnology, government support will open up more opportunity to invest in marine biotechnology." At the same time, he also stressed on the conservation of the marine resources. Dr Dave Dickenson, chief marketing officer, Stemcyte Corp., USA, who signed an MoU with the government to set up stem cell research facility in the state, said, "More than 70 diseases have been successfully treated with stem cells. These include cancers (leukemias, lymphomas, myelomas), blood disorders (thalassemias, sickle cell anemia, Fanconi anemia), and immune deficiency diseases. More lives can be saved by providing high quality, safe and effective stem cell transplantation and therapy to all patients in need." Dr William Rutter, CEO of US-based Synergics Inc, and founder of pharma giant Chiron Inc, sharing his views on 'Strategies for biotechnology start-ups,' said: "Gujarat has core competency in pharma manufacturing. There are opportunities and challenges in the biopharmaceutical space. Opportunities are there in research, drug development and clinical services. Emphasis should be given more on early prevention, diagnosis and drug efficiency." Joel Marcus, CEO of Alexandria estate, USA, Dr Kakoli Ghosh, agriculture officer, plant production division, FAO, Rome, Sudhir Vaid, CMD, Concord Biotech and Dr CN Ramchand, director, Kemin Pharmaceuticals, Chennai, also spoke at the sessions. Around 500 professionals including researchers and faculty from Gujarat University, Nirma University, Sardar Patel University, North Gujarat University, Veer Narmad South Gujarat University, GCRI, PERD, CSMCRI, NRCMAP and professionals from the industry participated in the seminar. The purpose of the seminar was to provide a platform for experience sharing of professionals, industries and investors, from state, national and international levels and seek their inputs, views and perceptions of Gujarat as destination for future biotechnology investment. Anandiben Patel, minister for education, Government of Gujarat, graced the occasion.   ]]> <![CDATA[Vibrant Gujarat attracts Rs 1,554 cr investment commitments in BT]]> https://biospectrumindia.com/news/95/2339/vibrant-gujarat-attracts-rs-1554-cr-investment-commitments-in-bt.html https://biospectrumindia.com/news/95/2339/vibrant-gujarat-attracts-rs-1554-cr-investment-commitments-in-bt.html Thu, 08 Feb 2007 14:28:00 +0530 New Page 1 Vibrant Gujarat attracts Rs 1,554 cr investment commitments in BT (L-R) Prasanta Biswal, CEO, International Biotechnology Park Ltd and Ramakrishnan, CEO, Akruti Nirman Ltd with Narendra Modi, chief minister of Gujarat. Gujarat has attracted total investment commitments to the tune of Rs 1,554 crore in biotechnology during "Vibrant Gujarat 2007", a global investors meet held on January 12-13, 2007 at Ahmedabad. The investment is expected to generate employment to around 7,714 skilled personnel in the next threeâ€“five years. In this regard, 18 Memorandum of Understandings (MoUs) were signed in presence of Narendra Modi, chief minister, Government of Gujarat and Anandiben Patel, minister of education, Government of Gujarat. Of the 18 MoUs signed, nine companies are from outside Gujarat while the rest are Gujarat-based companies. Various companies investing in Gujarat, include, one each in animal biotechnology, therapeutic proteins, contract research, enzymes, bioinformatics, infrastructure development, two each in stem cell research, agri-biotechnology and knowledge partnership, and five in healthcare biotechnology. According to official sources, around Rs 580 crore of investment has come into biotechnology park at Savli in Vadodara cluster while an investment of Rs 371 crore has come to the Ahmedabad cluster and Rs 100 crore in Kutch. Of the 18 MoUs, the major ones are investments from Akruti-Nirman-TCG Group for developing the biotechnology park at Savli. The Group has committed an investment of Rs 200 crore with a probable employment of about 20 people. MJ Biopharm, one of the oldest pharma giant having strong operation in biotechnology across Europe and Asia is investing about Rs 160 crore in the biotechnology park at Savli and envisages employment of about 15 personnel. The Zydus Group, one of the leading pharma giants of the state, is creating an employment opportunity for about 100 personnel, by setting up a large manufacturing and scale-up facility for recombinant biological therapeutics near Ahmedabad/Gandhinagar with an investment of about Rs 100 crore. Intas Biopharmaceuticals is coming up with two projects inclusive of an innovative project on transgenic animals, with a tie-up with a US-based biotechnology group to materialize ventures with a total investment of Rs 120 crore and an employment generation of about 95 personnel. IKF Technologies Ltd, a company that recently signed an MoU with IOC, shall install a one lakh-ton capacity biodiesel extraction plant as a part of biodiesel plantation and extraction project near Bhuj, with an initial investment of about Rs 100 crore and employment to about 1,000 persons. Similarly Stemcyte, a US-based company into stem cell research and cord blood banking has envisaged an umbilical cord blood banking and stem cells research facility near Gandhinagar with an initial investment of about Rs 85 crore and creating employment opportunity for about 50 personnel. Besides these, Alexandria, one of the biggest companies of the US, has expressed its commitment for developing biotech parks and incubator facilities and venture financing in biotechnology in Gujarat. Singapore-based Progenics, which specializes in supercomputing in bioinformatics solutions, is also keen on entering into collaboration with the state universities. Genzyme, one of the world's largest biotechnology companies, is also keen on working with the government of Gujarat in the healthcare space. According to the sources, the state has attracted around Rs 300 crore investment in biotechnology till 2000 and another Rs 200 crore in the last six years i.e. from 2000- 2006. The investment commitment to the tune of Rs 1,554 crore, incoming in five to six years, announced by different companies during the Vibrant Gujarat 2007 represents a quantum jump in investments in the state's biotechnology space. The government of Gujarat, in conformity with national efforts, has been organizing Vibrant Gujarat: Global Investor Summit once every two years, for bringing to the fore the enormous investment potential in Gujarat and to accelerate the rate of FDI and domestic investment in Gujarat and thereby in India. It shows Gujarat with its very strong pharma and healthcare, agriculture, animal husbandry sector, offers ideal platform for this fast-growing economy. The vast application of biotechnology, in these sectors and potential applications in marine, environment sectors make it an exciting area for business and investment.   ]]> <![CDATA[Rapid diagnosis of non-tubercular TB on the cards]]> https://biospectrumindia.com/news/95/2103/rapid-diagnosis-of-non-tubercular-tb-on-the-cards.html https://biospectrumindia.com/news/95/2103/rapid-diagnosis-of-non-tubercular-tb-on-the-cards.html Thu, 08 Feb 2007 14:25:00 +0530 Rapid diagnosis of non Rapid diagnosis of non-tubercular TB on the cards AIIMS scientist develops a novel molecular method for the detection of non- tubercular mycobacterial infections. With the resurgence of tuberculosis, especially in HIV infected patients, there has been increased focus on accurate diagnosis and treatment of TB, which is still rampant in the developing countries. Currently there exists a reliable methodology to detect pulmonary tuberculosis caused by the dreaded Mycobacterium tuberculosis, but there is still a lacuna in the detection of non-tubercular mycobacterial infections. Now, Dr Sarman Singh, head, clinical microbiology division, department of laboratory medicine at the All India Institute of Medical Sciences (AIIMS) in New Delhi, along with his team has successfully developed novel multiplex PCR primers for the rapid and accurate diagnosis of infections caused by Non-Tubercular Mycobacteria (NTM). Although the Mycobacterium genus represents a complex phenotypic and genotypic diversity amongst the more than 100 odd species, the most important human pathogenic species remains Mycobacterium tuberculosis. But, now with the AIDS epidemic, the significance of Non-Tubercular Mycobacteria also known as Mycobacteria Other Than Tuberculosis (NTM or MOTT) has increased. Most of these infections do not respond to the conventional anti-tubercular treatment and are misdiagnosed as infection with multi-drug resistant strains of M. tuberculosis due to lack of species identification, particularly in developing countries. Conventionally, the identification of mycobacteria upto the species level is very slow, labor intensive, hazardous and not always reproducible in the labs. To overcome the shortcomings of conventional methods, Dr Singh, who has been focusing on intracellular pathogens, zeroed on molecular techniques that are being commonly used in recent times. "The advantage with molecular methods is that they are rapid, highly sensitive and specific and can be used on a large number of samples", he said. "We have been working on the rapid detection of the extra pulmonary tuberculosis infection in HIV patients. In this direction,16S rRNA gene analysis is the most promising molecular method. The 16S rRNA gene is conserved in all the species of the Mycobacterium genus. Therefore this gene can be amplified by PCR in all species of Mycobacterium and the species can be identified by species specific probes or PCR primers," explained Dr Singh. But rather than developing species specific primers for each non-tubercular species of mycobacteria, the researchers took advantage of the fact that a cluster of 5 genes (esat-6) is conserved only in the Mycobacterium tuberculosis (MTB) complex species but is deleted from most non-tubercular mycobacterial (NTM) species. This gene cluster codes for an early secreted antigen and has been used as a target for molecular diagnosis of TB by Dr Singh's team. In this way a novel method for differentiating MTB complex from NTM was developed, that uses a pair of PCR primers targeting 16S rRNA and esat-6 genes. These PCR primers have been patented. Dr Singh's group did a study based on this methodology at AIIMS (Published in the Japanese Journal of Infectious Diseases, Feb 2007) and found that the prevalence of non-tubercular mycobacteria was significantly high in the AIDS patients than in HIV negative cases (24 percent Vs 4.3 percent). "The rapid and accurate diagnosis of mycobacteriosis by this combination of genus specific PCR primers with novel esat-6 primer set gains significance in the light of the fact that most non-tubercular mycobateria are not susceptible to conventional anti-tubercular treatment, it becomes desirable to identify these isolates up to species level, particularly from AIDS and clinically unresponsive cases, which are often considered as drug resistant cases," stated Dr Singh. "By using this multiplex PCR directly on clinical samples, with the help of genus and species specific primers, the causative agent can be identified in a single run. The technique has already been standardized. The gel-based technology is ready for commercialization and for developing a rapid, non-gel based technique, it will take us another year or so. We ultimately want to have a strip or a dot kind of simple diagnostic test," he added. In addition, Dr Singh is also working with the National Physical Laboratory, New Delhi, on the concept of biosensors for TB diagnosis. Diagnostic kit for leishmaniasis Dr Sarman Singh had earlier developed a diagnostic system (Signal-KA), first of its kind in the world, for the early detection of visceral leishmaniasis. More than 90 percent of the world's cases of visceral leishmaniasis are found in India, Bangladesh, Nepal, Sudan, and Brazil. This is a parasitic disease spread by the bite of infected sand flies. Signal-KA diagnoses the deadly visceral leishmaniasis (VL), commonly known as Kala-azar (KA), with 100 percent sensitivity and specificity. It is based on a novel recombinant antigen indigenously developed by Dr Singh's group at the department of laboratory medicine, AIIMS, through DBT support. The test is based on detection of antibodies in the patient's blood, against a novel recombinant antigen cloned and expressed from a clinical isolate of Leishmania donovani. The process and the product have been internationally patented in 2003 and the technology has been transferred to Surat-based Span Diagnostics in 2005. The company then has developed an immunofiltration rapid test using this patented product and process, thereby reducing the test time to less than 10 minutes. This has made this rapid flow-through test field friendly that can be used in the remotest areas of the country without the requirement of refrigeration, electricity or any other paraphernalia. Priced at Rs 100, the test system produces results that can be seen with naked eyes. Span did the clinical and field trials in various Kala-azar endemic and non-endemic areas with highest possible accuracy and reproducibility. This kit was dedicated to the nation by the Union minister for science and technology and earth sciences, Kapil Sibal in February last. It is learnt that the kit has received good response and has made an impact on the sale of its competitive brands. In recognition of his efforts, the biotech product and process development and commercialization award 2006 was conferred on Dr Sarman Singh for the indigenous rapid test system. Now the kit is being exported for its evaluation in Sudan, Ethiopia, Kenya and other countries through WHO, Geneva. Early and rapid detection of the disease is extremely important to initiate specific treatment and curtail the transmission of this vector borne disease. The disease is fortunately treatable if diagnosed at an early stage. Therefore, this development is a landmark development in the direction of Kala-azar Elimination Program, which envisages elimination of this disease from India and Nepal by 2012. "With Signal KA already in the market, now we have further worked on the Post Kala-azar Dermal Leishmaniasis (PKDL) strains and conclusively proved that the strains causing PKDL and VL are genetically different strains. This negates the earlier premise that the strains causing PKDL are same as the VL causing strains," shared Dr Singh. His lab has already created PKDL specific recombinant antigen, which could form the basis of a two dot test for differentiating between the two kinds of leishmaniasis (VL and PKDL). Dr. Singh has also designed novel set of PCR primer to differentiate between VL and PKDL strains of leishmania. These primers have also been patented. "Now the privates sector has to come forward for commercializing this technology but since the number of PKDL patients are very few so the interest of the private parties has been lukewarm," he said. Hopefully, some private entrepreneur will soon take this technology also to the masses. Rolly Dureha     ]]> <![CDATA["The second decade of commercialization of GM crops will be in Asia"]]> https://biospectrumindia.com/news/95/2678/the-second-decade-of-commercialization-of-gm-crops-will-be-in-asia.html https://biospectrumindia.com/news/95/2678/the-second-decade-of-commercialization-of-gm-crops-will-be-in-asia.html Thu, 08 Feb 2007 14:19:00 +0530 New Page 1 "The second decade of commercialization of GM crops will be in Asia" Dr Clive James, chairman and founder, ISAAA, was in India recently to release the finding of the ISAAA Annual Report 2006. In an exclusive chat with BioSpectrum, Dr James shared the key highlights of the report, its impact, and the future prospects of the GM technology. How do you view the ISAAA activities in India? The ISAAA activities in India have been extremely successful. When we established the office here, the aim was to share knowledge with all segments of the Indian society. And if I can use an example from the 2005 release that we did from Sao Paulo, Brazil, we were able to reach 500 million people on a global basis. That is an incredible number; almost eight percent of the global population and 195 million of those people were in India. So we have been more successful in sharing knowledge in India than any country in the world. This is very good as it is through knowledge that people can make knowledge-based decisions about this technology. Our philosophy in terms of sharing is that we share the knowledge but we respect the independence of others to make decisions based on that knowledge. In this context, the investment in India has been very successful. We will continue to work at the different levels with different institutions to even excel on the 195 million people that we reached in 2005 and hopefully the target for 2006 will be 250 million or more. What are the highlights of the ISAAA Annual Report in 2006? The release in 2006 is probably one of the most powerful releases that we have made. And the reason for this is that it has reached three major breakthroughs. First, 2006 is the first year when we have breached the 100-million hectare mark, 102 million hectares were planted in 22 countries in 2006 with transgenic crops, a very important historical milestone. Second, the number of farmers reached over 10 millions for the first time, 10.3 million compared to 8.5 million in 2005 and amazingly 90 percent of those are resource-poor farmers. So we have 10.3 million farmers in 2006 that have benefited significantly from this technology. The third significant milestone is that if one looks at the period from 1996 to 2006, there has been double digit growth every single year, which tells something about the farmer's view about this technology. So over the 11-year period, we have actually planted more than half a billion hectare, 577 million hectares to be precise. Now from India's point of view, the most important development in 2006 has been that for the first time, India has planted more Bt cotton than China. India is now the leader in Asia in terms of acreage. In 2006, 3.8 million hectares, almost a tripling of area from 2005 when it was 1.3 million hectares, compares with China at 3.5 million hectare. And in terms of number of farmers there were 2.3 million farmers that benefited from Bt cotton in India in 2006. From Asia's perspective, what has been the progress made in agricultural biotechnology? If one looks at the first decade of commercialization, from 1996 to 2005, undoubtedly the first decade belonged to the Americas. But my sense is that the second decade of commercialization will be in Asia with the two most populous countries, China and India playing a major part in it. If we look at the figures in 2006, then the biggest absolute gain was still in the US at 4.8 million hectares. The US still has 53 percent of the global acreage but if one looks at the percentage in the developing countries, it has increased every single year, from 1996 until 2006. In 2006, 40 percent of the total global area was grown in developing countries. Now that is a trend that we see continuing. The technology may also be developed in the public sector, in public sector institutes in India, China and Brazil. So the landscape of who owns the technology will change and that is a big issue for many people. Once you get the technology coming out of the public sector, the critics of this technology will not be able to say that it is exploitation by the private sector; they will have to find another reason. What is your take on the detractors of this GM technology? I think Greenpeace is green with envy. Probably they would like to be in the driver's seat where they see decreasing acreage of GM crops, because of dissatisfaction, low acceptance but in fact the reverse is true. It is true that the adoption of GM technology is increasing at the rate of more than 10 percent per year, but what one sees is that in 2006, more than half of world's population lives in countries where biotech crops have been approved, have been used and are generating very significant benefits. So I think Greenpeace and Friends of the Earth must be feeling very frustrated that all their predictions are going the other way. It is a mystery to me that how Greenpeace and Friends of the Earth can say that this technology is not delivering any benefits when over the last six weeks, we have five reports: one from the National Council of Agriculture in Washington DC, another one from Switzerland-from independent public sector institutes looking at the environmental issues and coming up with positive comments; last week we had PG economics documenting the fact that in the first ten years farmer income went up by $27 billion; Reports from Argentina estimating that Argentina alone has benefited at the farm income level by about $20 billion. And if we look at the benefits for the rest of the world due to the fact that they are producing more soyabean and therefore the lower prices, it adds up to another $47 billion; so the total benefits are to the tune of $67 billion. We see a very rigorous analysis of the benefits in these studies. So finally, do we believe that all these five studies are wrong, while Greenpeace and Friends of the Earth that provide no data suggest it is the other way. I think that the public can decide. What is the future agenda and vision for ISAAA? We will continue to share knowledge and build up a database that is very significant. This will constitute a body of evidence, which will be very important in summarizing and documenting what actually happens at the field level. We will work with different groups at the farmer level, policy level, and government, both federal and state, level to make sure that they have the necessary information. The next decade will brings a whole new set of traits which will be very important for a country like India, in particular, golden rice which will be available for commercialization within 5 years from now. Next a drought gene will be released, probably in 2010-2011, in the US. It will be in corn but the gene will also be available in cotton, in soyabean, and in wheat. The gene is available from both in the public and private sector. We are looking at omega 3 soyabean becoming available in about five years. High lycine corn has been already approved in the US in 2005. The quality traits that people have been talking about for a long time are going to become available as well as the agronomy traits like the drought gene. The other factor that is going to have a huge influence on the whole adoption of biotech crops is biofuels- jatropha in India for biodiesel, ethanol from sugarcane. So biotechnology and GM technology in particular will play a very important part in making the biofuels competitive in terms of price. If we look today at Brazil, for instance, it is the biggest producer of sugarcane in the world and can produce ethanol at 18 cents a liter. That compares with 31 cents a liter in the US from corn. These are the exciting developments and my sense is that even though the rate of adoption in the first decade was unprecedented, we will see even steeper rates of adoption in the second decade and Asia will be the region where most of that will happen. Rolly Dureha   ]]> <![CDATA[Reaction from the BioPharma Sector]]> https://biospectrumindia.com/news/95/2973/reaction-from-the-biopharma-sector.html https://biospectrumindia.com/news/95/2973/reaction-from-the-biopharma-sector.html Thu, 08 Feb 2007 14:15:00 +0530 Reaction from the BioPharma Sector Reaction from the BioPharma Sector The HR heads and CEOs of some reputed BioPharma companies, Thomas Putti, head, HR and administration, Advinus Therapeutics, Dr BB Lohray, CEO, BHUVID Research Laboratory, Ahmedabad, Dr JN Verma, CEO, Lifecare Innovations, Dr SV Kapre, executive director, Serum Institute of India, share their views on the biotech HR supply and demand situation in the country. Is there a shortage of qualified workforce? How should it be overcome? Thomas Putti: Yes, there is an absolute shortage of qualified workforce. BT is seen as next wave on the way after IT and it is going to be huge. It is important for us to prepare for it. We need to have more effective academic programs around BT. Some of the universities have started offering these programs. We need to go a long way in making our curriculum more industry-specific. Further the institutes need to jointly come out with plans to orient postgraduate students on the laboratory working. Dr BB Lohray: Yes, to some extent. But there is also an increasing flux of talented scientists returning home from abroad, especially in biotechnology area, who are very well trained and can train others with required knowledge in this area. Our university education is still not at the cutting age and we are still teaching rudimentary and outdated syllabus. Universities also lack excellent teachers due to poor emoluments and poor laboratory set-up. I suggest that selected universities and government laboratories in each state may be directed to conduct practical laboratory work for 6 months (4th Semester) for all the students in that state and sufficient funds may be allocated to do this. Most of these laboratories and universities, which have research programs, could appoint a few associate professors additionally to impart this specific training to MSc students. This system is prevalent in Germany and many of the students get absorbed in industries even before they finish their fourth semester, since they are very well trained in research labs. Dr JN Verma: I have been on the interview committee of BCIL and over a period of time, I have realized that the focus of students is misplaced. All of them just want to do R&D, but most of them are either not aspiring or willing to obtain a PhD degree. This is not going to take them anywhere in research. With regards to the biotech/life sciences industry, the students are not even aware of the companies active in this space and their general awareness about the industry is very low. During my interaction with the students, I found that there is a total disconnect with the industry. Many a times I have found that even the PhDs are clueless about the industry. When they appear for the interview in a company, they are quite confused and come with the premise that the industry will pay more as compared to a research institute. Because of this attitude and the fact that the company has to invest their resources in training the candidate, the initial salaries are quite low. Dr SV Kapre: Yes. The reason is when we talk of a qualified person, we talk of someone well versed with technical handling. Since the biotech industry that was not big earlier has started growing, the technology and administrative capacity needed is in large numbers. The earlier courses were never tailored with this in mind, as focused needs did not exist. Now the teaching institutes should cleverly tailor their courses to the present requirements. What is the present supply and demand situation in India? Thomas Putti: There is an obvious shortage of requisite talent available in India. I am not able to put a figure on the exact gap in demand-supply at this point of time. The shortage ratio could be very high as we progress towards 2010. Dr BB Lohray: The question of demand and supply in this context is quality based. There is a good amount of human resource available, which has MSc in various branches of biotechnology, microbiology, molecular biology etc., with average knowledge of the subject with absolutely poor practical skills. Therefore, quality human resource is a crunch in biotechnology for want of reasons mentioned above. JN Verma: What we get we do not want and what we want, we do not get. I feel that the demand-supply ratio is very high, as what we want does not exist. Overall, there is a lot more manpower available than required and there is no need for establishing new institutes. What does your company look for in candidates during the hiring process? Thomas Putti: Advinus looks for qualities like institution and academic record, functional knowledge, personality traits such as being energetic, flexibility in approach, ability to think innovatively and ability to accept and take constructive comments, ability and aptitude for working in a team environment, ethics and integrity. Dr BB Lohray: As I mentioned, industries are always looking for candidates with aptitude, good knowledge in basic fundamental of biotechnology, with good understanding of upcoming science and with a good practical experience in basic of biological science. However, for routine work, good practical hands are important. JN Verma: Ideally the industry would like to take in candidates, who have the ability to think, plan, execute, compile, present and draw conclusions. Is the biotechnology industry too facing attrition? Thomas Putti: Yes, there is a huge challenge of retaining the trained and experienced people. We are successfully handling attrition, constantly addressing people issues such as providing an environment of learning and constantly developing their capabilities, revising their packages where necessary, looking at a fast track growth for merit employees to match their individual aspirations. Dr BB Lohray: Yes, but to a much lesser extent at this moment since biotechnology is still not fully developed like IT sector in India. However, the situation will worsen as the biotechnology industry grows and the talented scientists find many more lucrative offers with better work environment. What are your suggestions to bridge the demand-supply gap and increase the talent pool? Thomas Putti: More universities need to offer programs in the areas of medicinal chemistry, molecular and cell biology and pharmaceutical sciences. Constant institute-industry interface on making the curriculum more jobs specific. Premier training organizations like NIIT also can play a big role in creating talent pool to meet the short-term requirements. Dr JN Verma: I believe that at the Master's level the industry should be invited to the academic institutes to talk to them and this should be done at the beginning of the course/ program. Industry visits by students alone are not sufficient. During the Master's education, there should be some kind of introduction to the industry. There is a need for a biotechnology management course or a biobusiness management course, which should be a part of the regular Master's program (MSc or MTech Biotech) and not as a separate degree. What are the current salary packages at the entry level and for those with 3-4 years of experience? Thomas Putti: The salary in this industry space will be driven by market forces and additionally it will depend on various factors such as qualification, university, skill level etc. The skills that are found scarce will demand premium. Dr BB Lohray: In fact, pay package depends on two major factors, the need for the skills in industry and second, the number of candidates they have to choose from. Also it depends in which city the job is going to be located, cost of living etc. Nevertheless, at present a general pay package for big cities such as Mumbai, Bangalore, Chennai, Hyderabad and Delhi, where most of these biotechnology companies are located is ranging from Rs 1.5-2.0 lakh/pa (BSc); Rs 2.0-3.0 lakh/pa (MSc); Rs 6.0-8.0 lakh/pa (Ph.D) and similar for MSc with MBA for fresh candidates. Salaries may be little less in cities like Ahmedabad, Pune and Kolkata. Experienced candidates, especially PhD with post doc experience in good laboratories abroad are in high demand and salaries may range from Rs 12-20 lakh. These numbers should not be taken as fixed package but only as a guideline.   ]]> <![CDATA[Reactions from the Bioservices Sector]]> https://biospectrumindia.com/news/95/2113/reactions-from-the-bioservices-sector.html https://biospectrumindia.com/news/95/2113/reactions-from-the-bioservices-sector.html Thu, 08 Feb 2007 14:11:00 +0530 Reactions from the Bioservices Sector Reactions from the Bioservices Sector Polyclone BioServices, Clinsys, Arkus, ClininInvent Research Pvt Ltd, Lal Path Labs are some of the new players in the Bioservices sector. Naveen Kulkarni, CEO, Polyclone BioServices Pvt Ltd; Dr Surinder Kher, chief executive officer, Clinsys India Limited; Dr Anupama Ramkumar, director, Arkus Clinical Trial Support Solutions; Dr Arun Bhatt, president, ClininInvent Research Pvt Ltd; and the HR Head, Lal Path Labs share their reactions to the questionnaire. Is there a shortage of qualified workforce? How should it be overcome? Naveen Kulkarni: Most importantly, the academia has to work with the industry to understand what is required by the industry. This is possible by way of projects, collaborative research activities and to achieve this, the academia has to provide with all possible information about what is going on in the institute/college at the research level and allow students to interact with industry people and companies. Dr Anupama Ramkumar: There definitely is a shortage of trained and aware workforce in clinical research industry. I guess the industry grew so fast that it took everyone by surprise. Though there are various training institutes focusing on CR now, I feel efforts have to be made to integrate this training and research ethos at the college level. This has to be part of the curriculum in medical schools or pharmacy colleges. Dr Arun Bhatt: Yes. The problem is essentially at the level of middle management-clinical study manager/project manager. These positions require prior work experience of several years as CRA/clinical team leader. There is limited ready talent available as the industry itself is still in its infancy. Except two-three CROs, the rest of the CROs are in business since three years. There does not seem to be a solution for short-term except for the CRO to invest in talented manpower, identify their potential and provide an environment to develop them into effective managers. It is also necessary for the industry as a whole to consider whether current strategy of luring young candidates with little experience and offering ridiculously high emoluments will hinder development of managerial talent. What is the present supply and demand situation in India? Naveen Kulkarni: There is a lot of demand for human resource in the biotech industry in India and this will only grow. The present supply of students is very high but mostly the sheer volume of students produced by the academia is not qualitative. The industry requires skilled resources which is not a very high expectation but just that they need to be "hands-on" about what they know theoretically. Dr Surinder Kher: It is challenging. As a country, the demand for trained clinical research professionals certainly is on an increase, which is directly related to the increase in clinical research activities in the country. We also see a number of clinical research facilities growing both within the bio-pharmaceutical companies and the contract research organizations. Unfortunately the new entrants in this space do not put in enough effort to train people, but instead look for trained people around. By doing this, the demand supply problem has compounded within this industry and the attrition is on a rise. Dr Anupama Ramkumar: Theoretically speaking, the supply should exceed demand because there are a large number of graduates coming out of the various institutions in the country. But the ground reality is the opposite. What these qualified graduates learn in their years at college is absolutely not in line with what is required at work. The awareness too about career opportunities is poor. The training institutes too do not have a uniform standard or curriculum and therefore the output not really consistent or as desired. Till the government and the industry make a concerted effort to address this issue, this supplyâ€“demand gap is going to remain as is. Dr Arun Bhatt: There are no exact figures available. However, for entry level, the supply is much in excess of demand. In contrast, at middle manager level, the supply is much less than the demand. HR Head, Lal Path Labs: As far as we are concerned, we don't find any dearth of required talent in the market, though, at times, it become difficult to get trained manpower in the remote areas. In those scenarios, we try to place experienced hands from within the system. It is easier to fill up those positions rather than finding incumbents in those remote areas. What does your company look for in candidates during the hiring process? Naveen Kulkarni: We need "hands-on" students who have good exposure to the basics of molecular biology with cloning, PCR and related techniques. Dr Anupama Ramkumar: This is a personal opinion. I would be happy to find a person with an attitude to learn and good communication skills, especially in English. A lot of companies who are ready to invest time and effort into imparting customized training will feel this way. Dr Arun Bhatt: Our focus on candidates who have basic knowledge of clinical research, have initiative, are good communicators, are focused on learning and growing and are willing to put efforts in self-development. Dr Surinder Kher: We look for some basic educational requirements-a biosciences degree preferably a Masters. People who have knowledge of GCPs or have participated in multi-country studies would get a preference. But over and above this knowledge, we look at certain essential skills like integrity, attitude, willingness to learn, flexibility, customer orientation etc in these individuals. I strongly believe that these skills are important to any business but extremely critical for business like clinical research, which is purely peoples business. We also look at the cultural fitment for people we hire based on these human skills. As we know we do not have lot of available clinical research people in this country (nor do we expect this in the short to medium term) we have to train people in house. HR Head, Lal Path Labs: As we are extremely conscious about the quality of our reports and also due to the fact that we are bound by the various accreditation bodies like CAP and NABL etc., we generally look for working hands in each area who have the requisite qualification and at least five years of practical experience, especially in labs having automated systems. Accordingly, the candidates are generally inducted from the competition. Are you satisfied with the students coming out from the biotech institutes? Naveen Kulkarni: No, because to a large extent their knowledge is only theoretical and rarely we find a student with adequate skills to handle the job. Dr Surinder Kher: Not really. The clinical research students with degrees/diplomas that we have seen so far have not met the expectations. It is very simple. When we say that there is dearth of CR professionals, there is even higher scarcity of people who can teach clinical research. There is no teaching related to practical aspects of clinical research. There is no teaching regarding basic soft skills required in clinical research. So the teaching institutes will have to address this as they grow. The students we have seen so far are just like any other students of biosciences with some additional theoretical knowlege of clinical research. Dr Anupama Ramkumar: It is difficult to answer this question with a plain "yes" or "no". There are some really good candidates that one finds and it is quite often. And the problem is not with the students, it is with the curriculum. Dr Arun Bhatt: So far only around 5-10 percent of students pass through our stringent recruitment process. What are the current salary packages at the entry level and for those with 3-4 years of experience? Naveen Kulkarni: BSc, MSc 1.2-1.8lakh, MBA in biotechnology 1.8- 2.4 lakh/annum and PhD 3.6 - 4.8 lakh/annum). Dr Surinder Kher: The packages in the current environment of attrition are difficult to benchmark. Also the degrees really do not make a big difference compared to relevant experience. The ranges for a fresher with the above degrees would be Rs 2-4 lakh/annum while as the range for a 3-4 years relevant experience with similar degrees can be Rs 5-10 lakh/ annum. Dr Arun Bhatt: There is no set package as of now. The fresh CRAs could expect annual emoluments (CTC) in the range of Rs 2-2.5 lakh/per annum. The package for experienced candidates depends on their prior experience and prior salary.   ]]> <![CDATA[Talent Crunch]]> https://biospectrumindia.com/news/95/1038/talent-crunch.html https://biospectrumindia.com/news/95/1038/talent-crunch.html Thu, 08 Feb 2007 12:47:00 +0530 New Page 1 Talent Crunch The Indian biotech industry is all set to reach the $5-billion mark by 2010. It has been growing at a CAGR of 30 percent since 2003-04 and at this rate the industry will touch the $25 billion mark in 2015. However, the industry and policy makers are ambitious to clock $40 billion in revenues by 2015. Clearly this means a lot of human resource requirement. BioSpectrum spoke to several key people in the industry to find out the status of the current requirements of manpower, quality of manpower, and the expectations from the industry, cutting across various sectors to gauge the mood and sentiments of the industry. We used the data collected during our surveys-BioSpectrum Top 20 Industry Survey and BioSpectrum-ABLE Top 20 Biotech Schools-to substantiate the overall feeling. The news is not so good. Though the demand is high, the supply is low. There is a huge gap between the industry's expectations and availability of quality manpower. The ensuing pages will tell the story. Dr MK Bhan, secretary, department of biotechnology (DBT), sees creating people for science and technology as the most important concern. "We failed in creating the human resources. We are way down in numbers. I see that as the biggest challenge. We can build many centers but there must be institutional leadership. They should also be engaged. The institutes need a new kind of drive and excitement. The old system and structure is not sufficient," Dr Bhan said. Though India's science budget is growing at 30 percent, it can grow much faster if there is a demand by the new structure. The scientific community itself needs out to reach out more. The sentiment expressed by the industry too is same. Almost all the respondents to our questions have the same concern that there is an absolute shortage of qualified workforce and that our university education is still not at the cutting age. While the issue of quality of education can be debated, there is unanimity about the existing shortage. Our recent survey on India's Top 20 Biotech schools showed that 60 percent of the students from the Top Public Institutions prefer to go abroad and study further rather than take up a job. This clearly suggests that the creamy layer is not joining the industry. Further, it has been observed that a clear gap exists between the academia's assesment of their students as against the industry's requirements. According to a study done by Leader Prospects India (formerly Nobby Nazareth Associates), a leading HR consulting company, one of the largest gaps in the academia was the lack of innovation and entrepreneurship culture. Another major gap has been the isolated approach between the academia and the industry. There are hardly any research collaborations. And the study points out that symbiotic approach to education will be critical to achieve a holistic learning and development. The industry on its part has to look at academia as information warehouses and knowledge power houses and assist the academia in translating this knowledge into beneficial outcomes. While the industry says there is a shortage of manpower, it was not able to quantify the extent of shortage. BioSpectrum estimates that the industry would need about 60,000 scientific people by 2010. This is a conservative estimate considering the fact that the industry is now shifting its gears.   ]]> <![CDATA[BioSpectrum presents Biotech industry awards 2006]]> https://biospectrumindia.com/news/95/1753/biospectrum-presents-biotech-industry-awards-2006.html https://biospectrumindia.com/news/95/1753/biospectrum-presents-biotech-industry-awards-2006.html Wed, 10 Jan 2007 12:24:00 +0530 BioSpectrum presents Biotech industry awards 2006 BioSpectrum presents Biotech industry awards 2006 BioSpectrum announced the winners of the 4th edition of the much-awaited biotech industry awards, BioSpectrum Awards 2006 for various categories, on December 11, 2006. At a glittering function hosted by BioSpectrum in association with Bio-Rad Laboratories in Bangalore, the BioSpectrum Person of the Year Award was presented to M Ramasami, Chairman and Managing Director of Rasi Seeds, Attur, for his efforts in giving cotton farmers in the country, quality Bt hybrids that have resulted in higher yields and lesser consumption of pesticides. The Life Time Achievement Award was conferred upon Dr RA Mashelkar, Director General, CSIR, for excellence in biotechnology for over three decades. Dr Mashelkar has left his everlasting imprints in the Indian biotech sector, by advising, motivating, and by removing the various obstacles in the way of the biotech industry. Dr Villoo Morawala-Patell, Founder and CEO of Avesthagen, was presented the Entrepreneur of the Year Award, for driving Avesthagen, one of India's hottest biotech companies, through an innovative business model which combines both product development and services. The BioSpectrum Biotech Leadership Award was presented to Kapil Sibal, Union Minister for Science and Technology, as a recognition to the outstanding change he has brought to the thinking in the science and technology environs in general and biotechnology in particular. The Product of the Year Award went to Plasma Proteins category of products (AlbuRel, ImmunoRel, ReliSeal, HemoRel A and ReliPlasma) developed by Mumbai-based Reliance Life Sciences. Plasma Proteins are used in critical life saving conditions and situations. Plasma proteins were almost entirely imported to India till Reliance Life Sciences launched the Plasma category of products in 2005. The awards nite was graced by industry pioneers like Dr Cyrus Poonawalla, Chairman, Serum Institute of India, who was the chief guest on the occasion, Dr MK Bhan, secretary, Department of Biotechnology, and Chairman of the BioSpectrum Awards Jury along with other biotech industry leaders. Speaking on the occasion, N Suresh, Editor, BioSpectrum, said, "It gives us immense pleasure to crown the champions of Indian Biotech industry. BioSpectrum has always endeavored to promote talent in the area of biotech and shall continue doing so". The awards night began with a panel discussion on what should be the biotech vision for 2015 and how to traverse this path, where industry stalwarts discussed the rising significance of biotech industry. Other results Bangalore-based Biocon Ltd bagged the BioIndustrial Company of the Year Award, for clocking revenues to the tune of Rs 85 crore in sales. While Pune-based Serum Institute of India bagged the BioPharma Company of the Year Award, the BioServices Company of the Year Award went to Quintiles India. Dhiren Wagle, the Country Manager for Bio-Rad Laboratories, who presented the award for these categories, said, "It's a matter of privilege for Bio-Rad to be associated with BioSpectrum". He added, " The biotech industry is in a boom phase and holds a lot of promise for the future." Mahyco Monsanto Biotech Ltd, the technology licensing arm of Monsanto for the Bt cotton seed, bagged the BioAgri Company of the Year Award, while Thermo Fischer Scientific was presented the BioSupplier of the Year Award. Namratha Jagtap ]]> <![CDATA[Year of Hope]]> https://biospectrumindia.com/news/95/1750/year-of-hope.html https://biospectrumindia.com/news/95/1750/year-of-hope.html Wed, 10 Jan 2007 12:19:00 +0530 Year of Hope Year of Hope Another year has gone by and a New Year reckons us with promise, at least for the biotechnology sector. Optimism and confidence about the future were on full display when the country's largest gathering of biotech leaders took place in Bangalore on December 11 for the 4th BioSpectrum Awards Nite. With the who's who of the industry in attendance, the panelists were optimistic about the industry crossing the $25 billion mark from the present $2 billion revenues by 2015. But Minister Kapil Sibal was even more bullish that the industry would pull in at least $40 billion by then and the policy framework was being geared up to meet the industry's requirements to reach the coveted revenue target. Dr MK Bhan, secretary, DBT, and Sibal outlined the various government initiatives that will boost the industry's growth in the long run. The industry leaders on the panel too concurred with these views and used the occasion to list a few hurdles which were facing the industry currently. And the attention of national policy makers were drawn to these issues. Many of the demands relate to removal of anomalies in the taxation structure and redirecting of intended fiscal benefits in tune with the specific requirements of the biotech sector. The best example is the tax concessions given to the biotech sector for the expenses in filing patents within the country. As biotech is a global industry, there is a demand that it will be more useful if these benefits were extended to expenses related to filing patents in major foreign countries. There are many such demands and BioSpectrum has collated them with inputs from the four key industry associations-ABLE, AIBA, CII and FICCI-to make it easy for the finance ministry officials to give them a sympathetic consideration. Overall, 2006 had been a good year for the biotech sector. A slew of first-of-its kind products in the country such as Biocon's anti-cancer monoclonal antibody, plasma products from Reliance Life Sciences, an anti-rabies vaccine from Bharat Biotech, etc were launched in the last 12 months. Globally too, some significant product launches happened and one of the most relevant product for the country is the vaccine against cervical cancer, Gardasil, launched by Sanofi Aventis. The US, Canada and Australia have started to make it available to young women who will benefit the most from this preventive vaccine. In fact, Australia, where it was developed, has decided to include it in the national immunization program. The Indian government too should take a cue from these developments evaluate the benefits of proactive steps for young women in the age group of 12 to 25 who will benefit the most from this wonder medicine. The results of the 3rd Top 20 Biotech Schools Survey done by BioSpectrum are available in this issue. There are a few surprises with the Thiruvananthapuram-based Rajiv Gandhi Center for Biotechnology emerging as the No.1 publicly funded biotech institution, ahead of some of the established players. This was the institution which was elevated to a Center of National Excellence by the government in early 2006 and the infusion of resources seems to be doing wonders to it. The survey had received excellent response with over 100 of the nearly 250 institutions taking part in it. There are separate rankings for the institutions that are fully funded by the private sector, and ranking of institutions based on different key parameters. With the new wave of entrepreneurship and the first set of entrants to the biotech sector all set to leverage their strengths in the market place in the coming months, 2007 and beyond promises to be very exciting for Indian biotechnology. ]]> <![CDATA[Chromatography Advisor # 3]]> https://biospectrumindia.com/news/95/4610/chromatography-advisor-3.html https://biospectrumindia.com/news/95/4610/chromatography-advisor-3.html Wed, 10 Jan 2007 12:15:00 +0530 Chromatography Advisor Chromatography Advisor # 3 Capturing large biomolecules with membrane chromatography The manufacture of genetic therapies requires processing highly purified protein or plasmid preparations that are free of contaminating proteins, viruses, nucleic acids, enzymes, and enzyme inhibitors. In order to meet these needs, quick methods for separating and purifying large molecular weight proteins and genetic vector preparations are essential. Traditional chromatography presents a number of inefficiencies given the large size and weight of the target molecules and slow diffusional flow rates. This advisor takes a closer look at the enabling technology offered by ion-exchange membrane chromatography for purification. It offers the potential to significantly accelerate cycle times, and help manufacturers bring new therapies to market faster. Removal of virus from flow-through (log10) MuLV                >4.73 PRV                  >4.13 BVDV                 0.40 PPV                 >6.98 HAV                >3.84 Capacity limitations of resin-bead chromatography Column chromatography presents several roadblocks to fast purification that ultimately limit its efficacy. Purification flow rates depend on diffusion into the pores of resin-beads, and since the vast majority of a resin's ion exchange groups are located within these internal bead pores, biomolecules have a long and restrictive diffusion path. Beads have a limited accessible surface area that makes them inefficient for purifying large biomolecules (>200kb) such as plasmids and viruses. Binding of these larger molecules occurs only on the outside of resin-beads and not within pores, leading to fewer available binding sites and limited capacity. The height of a resin-bead column is in part determined by the residence time needed for diffusion into the beads' pores. The column for DNA and virus capture is usually sized by flow rate and not by capacity. Therefore, in order to process large batch volumes, resin-bead columns are often much larger than capacity alone would demand. In scale-up, new hardware is an expensive endeavor, and column packing can also be labor intensive and unreliable. Porous membranes speed flow rates Membrane chromatography is better able to purify large biomolecules because it offers a three-dimensional structure with open (0.8um) pores. The large pore size creates channels for the immediate availability of all active chemistry groups on the membrane surface, allowing high binding capacities of large particles such as plasmids, DNA, and viruses, with almost no diffusional limitations. Due to the multitude of large pores with high internal surface area, capacity can be 10 times greater and flow rates 100 times faster than diffusion-limiting resin-bead chromatography Figures A and B demonstrate the difference in surface areas for binding between packed columns and membrane ion exchange. In the packed column (Figure B, left) the white areas represent resin-beads and blue areas represent flow paths. On the membrane (Figure B, right), the blue area greatly exceeds the white, illustrating the greater availability of surface areas for binding, which translates into a much higher flow rate. One type of ion exchange membrane is made of microporous polyethersulfone (PES) that has been chemically modified with charged, hydrophilic polymers. These polymers are cross-linked to the internal and external membrane pore surfaces to produce either sulfonic acid ("S") or quaternary amine ("Q") surfaces. "S" surfaces have negatively charged ion exchange groups able to capture most proteins while allowing most DNA, most viruses, and endotoxin to flow through unimpeded. Using the same principal for oppositely charged binding, "Q" surfaces are positively charged and remove negatively charged DNA, most viruses, endotoxins, and host cell proteins. The open convective-pore structure of these microporous PES membranes enables high mass transfer and biomolecular binding to large surface areas by direct fluid convection. DNA, virus, endotoxin and large protein binding to membranes is not limited by long diffusion times as seen in resin-based chromatography because the flow follows directly through convective pores. The adsorption capability of membrane chromatography has been well documented. For example, Q chemistry membranes have demonstrated binding efficiencies of 1013 adenovirus particles per ml bed volume of membrane. As Figure C shows, membrane chromatography has demonstrated effective removal of model viruses such as porcine, parvovirus, hepatitis A virus, murine leukemia virus, and pseudorabies virus at removal efficiencies between 104 and 107. Model viruses range in size and complexity. If a manufacturer's data demonstrate removal of these model viruses, it is safe to assume that the same purification protocol will effectively purge other similar viruses. Linear scale-up In resin-bead chromatography, diffusional limitations cause the maintenance of proportional flow rate and column configuration during scale-up to be challenging and expensive. By contrast, scale-up in membrane chromatography is a straightforward linear procedure because capacity is directly proportional to the membrane surface area (volume) and hence to the size of the membrane unit, where the bed height or number of membrane layers is held constant. With a large or small membrane unit, there is a direct correlation between flux (flow rate/pressure) and size. This makes it easy to scale-up to batch sizes of 10,000-20,000 liters or more. Moreover, because the capture efficiency (dynamic capacity) is much greater with membrane chromatography, the thickness of a membrane's stack (i.e. its bed depth) is not as critical as with resin-bead chromatography. As a result, membrane stacks are much flatter beds and smaller volumetrically, making them flexible and more easily scaled-up, while still providing for dynamic binding capabilities. For example, a membrane stack of 16 layers (~1cm thick) can bind as many as 1013 Adeno-associated virus per milliliter of packed bed (i.e. 1ml of membrane volume). The ability of new membrane chromatography technologies to handle high binding capacities and increased flow rates for DNA, viral and endotoxin clearance is a major advantage for biopharmaceutical manufacturers previously hindered by the inefficiency of traditional chromatography in screening large biomolecules. As gene therapy and vaccine products become more common worldwide, the pressure for production is expected to dramatically increase. Membrane chromatography's dynamic capacity and high throughput make it an enabling processing tool that can streamline production and lower overall manufacturing costs.   Ian Sellick, Marketing Director, Pall Corporation/BioPharmaceuticals   Note: This article has earlier appeared in Bioprocess International.   ]]> <![CDATA[Market for Real-time PCRs soaring in India]]> https://biospectrumindia.com/news/95/6195/market-for-real-time-pcrs-soaring-in-india.html https://biospectrumindia.com/news/95/6195/market-for-real-time-pcrs-soaring-in-india.html Wed, 10 Jan 2007 12:13:00 +0530 Market for Real Market for Real-time PCRs soaring in India In India, Roche, Eppendorf, Applied Biosystems, Stratagene, Corbett and BioRad are a few companies offering real time PCRs to the researchers. Bio-Rad is a leader in the Real-time and PCR market. It has applications in biopharma companies and in CROs. Real time PCRs are available in the price range of $20,000-60,000 per unit. According to industry estimates, about 65-70 systems are sold per year in India and the market is growing at the rate of 20-25 percent. Advantages Traditional PCR is measured at End-Point (plateau), while Real-Time PCR collects data in the exponential growth phase An increase in Reporter fluorescent signal is directly proportional to the number of amplicons generated The cleaved probe provides a permanent record amplification of an Amplicon Increase dynamic range of detection No-post PCR processing Detection is capable down to a 2-fold change Source: www.appliedbiosystems.com Applications Real-Time PCR can be applied to traditional PCR applications as well as new applications that would have been less effective with traditional PCR. With the ability to collect data in the exponential growth phase, the power of PCR has been expanded into applications such as: viral quantitation; quantitation of gene expression; array verification; drug therapy efficacy; DNA damage measurement; quality control and assay validation; pathogen detection; and genotyping Source: www.appliedbiosystems.com Anthony Jai Kumar, assistant manager, marketing, Eppendorf India, said, "The present market for real time PCRs is about Rs 10 crore, growing at rate of 40-50 percent. And about 85-90 units of real time PCRs are sold per year in the country with 30 percent absorption in biopharma companies/institutes. These are available in the price range of Rs 10-30 lakh per unit." The growth of Indian biopharma sector will continue to support the growth of real time PCRs market as these units offer many advantages to the biopharma researchers. PCR technology The PCR (Polymerase Chain Reaction) technique is a vital tool in many areas of science. It has revolutionized molecular biology. PCR is a key technology in life science research in which a segment of DNA or RNA is copied or "amplified" so that it can be more readily analyzed. PCR has completely revolutionized the detection of RNA and DNA. Traditional PCR has advanced from detection at the end-point of the reaction to detection while the reaction is occurring. According to reports, real-time chemistries allow for the detection of PCR amplification during the early phases of the reaction. Measuring the kinetics of the reaction in the early phases of PCR provides a distinct advantage over traditional PCR detection. Traditional methods use Agarose gels for detection of PCR amplification at the final phase or end-point of the PCR reaction. Real-time chemistry provides fast, precise and accurate results. Real-Time PCR is designed to collect data as the reaction is proceeding, which is more accurate for DNA and RNA quantitation and does not require laborious post PCR methods. Hence Real-time PCR is a powerful and rapid technique for nucleic acid amplification. The accumulation of specific products in a reaction is monitored continuously during cycling. This is usually achieved by monitoring changes in fluorescence within the PCR tube. And real-time PCR enables the detection of amplified DNA during the process of amplification rather than at the end, providing greater accuracy in applications such as gene expression quantification and genotyping. According to Rajasri Chandra, marketing manager, molecular and cell biology, Labindia Instruments (Applied Biosystems Division), "Real-Time PCR system can be of use in carrying out drug development studies. Genes that code for drug metabolism enzymes are important targets for study in both drug development and clinical research, as they influence individual drug (or xenobiotic) response. Another use is in sterility testing. Pathogen detection is possible using TaqMan Pathogen detection kits in the environment, as well as all ingredients that are used in developing the product. Many pharmaceutical companies use biological products as their ingredient. It is very important to determine that the final product does not contain residual DNA. Acceptable amount of residual host cell DNA in biological product is 100 pg per dose." Narayan Kulkarni   ]]> <![CDATA["Market for culture media growing at over 20 percent"]]> https://biospectrumindia.com/news/95/2685/market-for-culture-media-growing-at-over-20-percent.html https://biospectrumindia.com/news/95/2685/market-for-culture-media-growing-at-over-20-percent.html Wed, 10 Jan 2007 12:12:00 +0530 New Page 1 "Market for culture media growing at over 20 percent" -Dr GM Warke, CEO, HiMedia Laboratories Started as an import substitution company, by a small team of researchers from Bombay University in the Mid 70s, for bacteriological culture media, HiMedia Laboratories rose to the occasion by catering to comprehensive needs of the laboratory sector. Today HiMedia, an ISO 9000 company, is rapidly emerging as a plant tissue culture, animal and insect cell culture, molecular biology and immunodiagnostics company. HiMedia, including the R&D staff of 25, has a total employee strength of 525. It has been exporting its range of products over 2,000 in number in dehydrated culture media, bulk raw materials for fermentation, laboratory chemicals, antibiotic sensitivity products and laboratory consumables to over 80 countries and at the same time reaching the Indian customers through a network of 2,000 distributors. Recently HiMedia has launched veg peptones that match the performances of all the traditional animal/bovine based peptones in North America and Australia, through an alliance with VWR International, a pure play global distributor. BioSpectrum spoke to Dr GM Warke, CEO, HiMedia Laboratories, about HiMedia and the market for culture media. Excerpts of the interview: With increasing use of culture media in biopharmaceutical companies, how do you see the market potential for culture media in India and world over? And at what rate is the market growing? One of the most critical and important raw materials for biopharma is culture media and is directly proportionate to the growth of the industry. The culture media (for both microbial and cell culture) is growing at over 20 percent. The present decade has shown tremendous growth and investment in the pharmaceutical sector in India as well as globally. The growth potential observed pertains mainly to regulated markets. Several Indian biopharma companies are at the sourcing end for these markets, and these are the ones that require quality assured, consistent and cost-effective raw material supplies with various quality systems and certification program. HiMedia is in a sound position to cater to this market. Apart from Indian manufacturers, many global biopharma players have identified HiMedia as a reliable raw material source for their production lines. In your view, what would be size of market for culture media in India and globally? According to our estimate, the size of culture media in India would be around Rs 150 crore. Globally the market for microbiology culture media is about $1 billion and for cell culture media it is about $3-4 billion. Who are global players in culture media and how do you see the competition in this market? Globally there are a handful of companies that deal in culture media. In microbiological culture media, we have BD, Merck, Oxoid and bioMerieux while in cell culture media, the players include Invitrogen, Sigma and Cambrex. Biopharma companies, which consume cell culture media, have overseas contractual arrangements with strings attached. Their commitment of importing raw materials at an exorbitant price may weaken in the face of convenient (time to come in) prices made available by the HiMedia. Today we are a leading global player in microbiological culture media and has established ourselves as a leader as an only company which has a complete range of 750 animal-free media used in every industry. Which are the other Indian companies operating in this space? There is no competition to match the quality and sweep of HiMedia product range. However, there are small players such as Titan Biotech who cater to clinical and pathological segments. Recently HiMedia launched veg peptones. What is the initial feedback you have received and when are you going to launch these products in India? The launch was successful and the top biopharmas are in the process of evaluating and validating the HiVeg line of products. What is the strategy/model you have adopted to reach out to global customers? World-class quality products at affordable prices have been the backbone philosophy of HiMedia for the last 30 years, which has been acknowledged by International competitors. With state-of-the-art facilities and all necessary certification and accreditations in place, HiMedia is at par with global competition. Narayan Kulkarni ]]> <![CDATA["Agronomic research along with extension machinery needs to be strengthened"]]> https://biospectrumindia.com/news/95/1353/agronomic-research-along-with-extension-machinery-needs-to-be-strengthened.html https://biospectrumindia.com/news/95/1353/agronomic-research-along-with-extension-machinery-needs-to-be-strengthened.html Wed, 10 Jan 2007 12:10:00 +0530 New Page 1 "Agronomic research along with extension machinery needs to be strengthened" Dr SA Patil, who took over as the director of the Indian Agricultural Research Institute (IARI) in September 2006, is a seasoned agricultural scientist with first hand knowledge of farmer's needs. In an exclusive interview with BioSpectrum, he outlines his vision for bringing about agricultural progress in the country. Excerpts: Given the current status of agricultural research in the country, what steps are needed to take it forward and usher in another green revolution? The national agriculture research system, that is, both what the Indian Council of Agricultural Research (ICAR) and the State Agricultural Universities (SAUs) are doing, has to be relooked into. Now the approach is through coordinated research projects, networked and innovative projects. The national agricultural research system has done a commendable job in research but the extension machinery to take this knowledge to the doors of farmers is weak. For example, now the variety release and notification is at the national level whereas many varieties are developed and recognized at the state level for location-specific areas. The cumbersome notification procedure does not allow these varieties to be put in the seed multiplication chain and therefore there has to be special permission for location specific varieties, farmer recognized varieties, and varieties with novel properties. Second, agronomic research and agricultural engineering research have not taken the roots for adoption. For example, soil and water conservation measures, rainwater harvesting, efficient water use systems, high income oriented cropping pattern and integrated farming system has not garnered adequate attention and always much of the focus is only on newer varieties and hybrids. There should be concerted effort to spread these technologies. And these can make the second green revolution equally or more successful than the first one. What is the relevance of modern techniques like molecular biology, recombinant technology in bringing about agricultural progress? These are very much essential. Man took thousands of years to domesticate wild weedy plants into crops which are currently feeding the human race. Otherwise, man would have still been hunting for his food. With the population increasing enormously and the land being limited, the human civilization has to constantly use newer and newer technologies to increase the yield per unit area along with the nutritional quality of the food. In the 20th century, with the tools available from traditional breeding methods through mutation and hybridization, he has been able to sustain the population. Now with the developments in physics, chemistry and biology, biotechnology has taken birth at the end of the 20th century and the whole 21st century will again be a biological scientist's century. There is nothing wrong in extending the principles of reproduction, which was otherwise limited to within species, to interspecific and intergeneric and even between animal and plant kingdom. The whole biological (both animal and plant) kingdom, both genera and species, can be looked as a single gene pool and the improvement what the breeders are doing within a species gene pool is now extended to the whole biological kingdom. For human welfare, gene from any organism is desirable and it can be put from one organism to another organism for the benefit of human kind. However, sufficient biosafety measures through systematic toxicology studies need to be undertaken before it is released for multiplication and general cultivation. In addition, the aspect of GM products should be seen in the perspective of ecology as well. I believe that any country adopting the biotechnological tools have sufficient regulatory measures put on the agenda before they are adopted for cultivation. This being the case, there is an urgent need to adopt molecular biology techniques for agricultural progress. What are your comments regarding the sustained opposition against GM crops. How can this be countered? I am from Karnataka, where there is considerably more anti-activism against GM crops. However, we could convince many of the so-called anti-activists regarding the gains from modern technology. We even held one-to-one discussions with a large number of farmers and anti-activists along with students and scientists of the university on one platform. Although the general populace was convinced about the benefits of GM crops, they had a notion that this (research on GM crops) is mostly done by multinationals and they are quite okay if the same is done by the national system. Like your BioSpectrum magazine, I think there is scope to have a one-page column in the daily newspapers to give the benefits of biotechnology through success stories achieved by farmers with facts and figures. In this way the effectiveness of modern technologies will enter the minds of even the common man. In addition, people opposing the new technologies can be brought on a common platform to discuss the merits and demerits of GM crops. What is your future vision for the India's agricultural community? And how can it be achieved? India is full of small and marginal farmers with a lot of illiteracy and poverty and they are unable to utilize the modern technologies. Therefore, the government has to come out with massive infrastructure and technology backup through product multiplication at village level and distribute it amongst the farmers with their full participation. For example, the service sector for land preparation, irrigation, land protection, and post harvest technology can reduce the expenditure at individual farmer level to about one third. Similarly, establishment of seed banks, fodder banks and food grain banks can avoid cost on administration, transport, etc, and these products will be available at the village level at half or even less than half the price. This requires strengthening and training of wise farmers and using them as leaders for transfer of technology. I feel that the microfinance model, which the Nobel Laureate Mohammad Yunus has shown at Bangladesh can be inducted into the country. An organized marketing system with credit facility at the village level will solve many problems related to the unscrupulous money lenders. Since taking over the reins of IARI, what are the important issues on your agenda? I am very happy and feel lucky that from a state organization (as vice chancellor of Dharwad University) I got a chance to serve at a national institute like IARI, which is the most premier institute of the country, both in academics and research. As everybody knows that the seeds of the green revolution were sown first at IARI, I feel that the seeds for the second green revolution also will go from this premier institute. I would like to put the institute at the international level in the modern basic and strategic sciences like biotechnology, nanotechnology, post harvest technology, high tech horticulture, organic farming and provide leadership to the entire country. On the other hand, I would like to establish a direct channel for progressive farmers in the country to visit to IARI and take the product and knowledge directly, and train SAU scientists in the modern technology so that they can quickly spread it to the different agro climatic regions of the country. Trained manpower is the biggest hurdle facing any knowledge-based sector today. How can India develop a pool of trained human resources in this sector? I feel that presently we are producing around 20,000 graduates and 7,500 post graduates which is not even equal to one state like Karnataka which produces 35,000 engineers annually. Although 70 percent of the population in India is dependent on agriculture, the meager member of graduates that we produce should be increased with skill, quality and entrepreneurship. There has to be cutting edge technology degree program with management backup so that agriculture also takes the status of an industry in the coming years. Every individual human wants to live more than a century with quality food today. And this can happen only if the poor farmers get the benefit of modern technology at an affordable rate. To bridge the gap between modern technology and 70 percent of the farming population, trained manpower is needed at the graduate and post graduate level and also there is need for intermediary and lower level skilled manpower in paramedical and para engineering segments today. Depending on the technology, process and systems, based on the potential of the agro climatic zones of India, the human resource development program should be planned accordingly, pooled and used. I am sure that a day will come when trained farmers will be required to take care of agriculture in other countries as well. I feel that the Indian population can take advantage of this factor, as already Africans and Canadians are demanding farmers from India. Rolly Dureha   ]]> <![CDATA[Sydney puts up a biotech show]]> https://biospectrumindia.com/news/95/2129/sydney-puts-up-a-biotech-show.html https://biospectrumindia.com/news/95/2129/sydney-puts-up-a-biotech-show.html Wed, 10 Jan 2007 12:07:00 +0530 Sydney puts up a biotech show Sydney puts up a biotech show It rained biotech Down Under for four days from November 19, 2006 at Australia's most happening city as it got ready to herald the summer. The largest gathering of biotech professionals in the region drew top minds from across the world to discuss the promising future of biotechnology. Biotech boom attracts huge VC funds It is boom time for biotech companies seeking funds. The industry globally is likely to attract investments of $26 billion in 2006 and has already got nearly three-fourths of it by September. "This is going to be second largest year for biotech investments, surpassing investments of $20.8 billion in 2004. The largest was in 2000 when the industry got $31 billion," said Michael McCully, director at US-based investment company, Recombinant Capital. McCully was delivering a keynote address at the AusBiotech 2006 Conference. The 30-year old biotech industry was reaching the stage of maturity and has had a significant number of blockbusters, which are attracting investor attention, McCully said. He said biotech had 23 blockbuster drugs, each exceeding sales of $1 billion last year and biotech drugs cornered sales of $43 billion in 2005. The world's largest selling biotech drug in 2005 was Enbrel from Amgen with sales of $3.6 billion, followed by Procrit ($3.4 bn), Procrit ($3.3 bn), Aransep ($3.27 bn), Rituxan ($3.154 and Epogen ($2.45). About the increasing investor attractiveness, McCully said the top-three biotech companies alone raised $7.45 billion in the first nine months of 2006. Amgen raised $5 billion, Gilead Sciences $1.3 billion and MedImmune another $1.15 billion debt. "This is a good sign for the biotech industry as trickle down effect will ensure that smaller entrepreneurs too get their funds," he added. The AMEX BTK index of Top 30 publicly-traded biotech companies had grown by over 30 percent, compared to 25 percent in 2005 and 11 percent in 2004. However, the overall Nasdaq index covering 231 companies had shown an average increase of only five percent this year. Michael said the financial markets were in awe of companies with drugs in the last stages of development and not many VCs were interested in companies having drugs in early stages of development. Further, most VCs were looking at late companies for acquisition for further sale to the Big Pharma companies. The Big Pharma, he said, had deep pockets but shrinking product pipelines and were on the look out for promising biotechs. New Zealand pitches for top biotech slot New Zealand is all set to lay the foundations for taking the top slot at the global biotech table but with a careful approach to suit its unique environment, said the country's Minister for Research, Science and Technology, Steve Maharey. "We want to become the biotech king, but with an industry that cares," Maharey told the delegates of the concluding day of the AusBiotech 2006 conference in Sydney. He pointed out that his country was no longer a bit player but has been forging regional alliances in this area to promote meaningful and sustainable biotech research in the region. Together with Australia, the region was the world's fifth largest biotech hub, he pointed out. Focused mainly on its bread and butter agri industry, biotech industry in New Zealand is quickly moving up the value chain. The minister said country's $811 million industry has collectively earned profits of $164 million last year. The industry employs 2,264 people of whom 14 percent were PhDs. Already 10 biotech companies were listed on the New Zealand Stock Exchange and another four on the Australian Stock Exchange.There are 126 biotech companies in the country with 87 of them in the private sector, 30 in the public sector and nine run by academic institutions.New investments were going into the healthcare biotech sector and the government had spent nearly $195 million for biotech research. This was one-fourth of all the government allocation for research, Maharey said. The country was focused on developing high value agricultural products and a large number of promising technologies and products were under development in the country. The focus area were clonal propagation, marker assisted breeding, biocontrol agents, enzymes and functional foods. New Zealand has also revamped and put in place an efficient, hassle-free regulatory system and provided a single-window mechanism to handle regulatory affairs. Prof. Gregory Winter, considered the father of monoclonal antibodies (MABs) from the MRC Laboratory of Molecular Biology, UK, and Prof Ian Fraser, selected the Australian of the Year 2006, were among the prominent names who shared their perspectives on the growth path biotechnology. "This is the largest gathering of biotechnologists in the country, with nearly 1,500 delegates," said the event organizer, AusBiotech's CEO, Dr Anna Lavelle. The 2005 edition in Perth, Western Australia, had about 1,100 delegates. Over 90 exhibitors displayed their wares at a huge exhibition hall at the Sydney convention center overlooking the happening part of Darling Harbor. Almost every one was optimistic about the future of the biotechnology sector globally, which turned 30 this year. Modern biotech industry's birth is counted from the date of the launch of Genentech, the $6 billion biotech major in San Francisco, in April 1976. At the same time, as the industry struggles to become profitable, weighed down by the huge costs of drug development, there were calls for continued support from the public with funds and enthusiasm to continue on the growth path. In fact, this was the theme of Dr Fraser's talk while narrating the difficult terrain traversed by him to develop the world's first vaccine against the Human Papilloma Virus (HPV). In his inimitable way, he narrated the long struggle to get financial support to conduct the arduous development process, clinical trials with the limited infrastructure which even a highly developed country like Australia had a decade ago. "In the US, where the biotech industry is most advanced, at least 44 percent of the average $198 million spent on developing a single biotech product comes from public sources, " Dr Fraser said quoting a recent study while delivering the key note address.After initial product development, it takes an average of $361 million to conduct clinical trials of a biotech product in eight years. In fact, the clinical phase consumes nearly three-thirds of the total product development cost. The risk was the highest at this stage and this cannot go on to become successful without government support, he said. "The governments have to continue to invest in biotech product development because this industry requires great product, excellent infrastructure and immense networking between organizations," Dr Fraser said. He gave an overview of the development of the HPV virus and pointed out the lack of advance infrastructure required to all the studies in Australia during the development phase. We need to choose a substitute business model for the biopharma industry to continue to maintain and grow its capacity and deliver great products," Dr Fraser emphasized. About HPV, he pointed out that recent studies indicated that the vaccine was preventing the onset of cervical cancer in 70 percent of the unscreened population. The vaccine, based on virus-like particles, was also showing encouraging signs in controlling genital warts. There were nearly 350 delegates from outside Australia and a large number of exhibitors from India, China, Taiwan, UK, US, Canada, South Korea, Japan, Singapore and New Zealand. Dr Reddy's from India made a strong presence. The trade development agencies of the UK, Philadelphia, many provinces of Canada, South Korea and Japan were present in a big way. The state of New South Wales where Sydney is located also made a strong pitch for investments. "This region has the largest collection of biotech and biomedical companies and has set up a $30 million fund to help research efforts," said NSW's director general for regional development, Loftus Harris. He also emphasized with the increasing number of people over 65 in the country, governments were keen to support the development of less costly medicines to keep the health budgets under control. A highlight of the event was the special award given to Australia's much-admired Gene Technology Regulator, Dr Sue D Meek. Australia enacted a widely admired exclusive Gene Technology Act early this decade and created the professional regulator for this sector. There was also a lot of buzz around the biotech drug Gardasil developed in Australia and licensed to Merck in 2006. The 2007 edition of AusBiotech will be held in Brisbane. Narayanan Suresh in Sydney   ]]> <![CDATA[Ontario looks at Asia]]> https://biospectrumindia.com/news/95/1689/ontario-looks-at-asia.html https://biospectrumindia.com/news/95/1689/ontario-looks-at-asia.html Wed, 10 Jan 2007 12:05:00 +0530 Ontario looks at Asia Ontario looks at Asia The Canadian province is working towards attracting investments from Asia Ontario, a Canadian province, has many discoveries to its credit such as Diphtheria Antitoxin (1914), Insulin (1921), Pablum (1930), Pacemaker (1951), Progenitor Blood Stem Cells (1961) Development of L-DOPA (1960s), T-cell receptor (1984) to name a few. Sir Frederick Banting and J J R Macleod won the Nobel Prize for their work with Charles Best for the discovery of the role of insulin in 1923. Medical devices 22,000 employees 600 companies Recorded revenues of $3.8 bn (CDN $5 bn) in 2004 Home to more than 60 percent of Canada's medical and assistive technologies (MAT) companies Includes global companies such as GE Medical Systems, Siemens and Johnson & Johnson Medical Products Biotech Canada's largest and North America's third-largest regional concentration of biotechnology firms Over 130 biotech companies and 60 research centers. 2,500 highly educated scientists, engineers and technicians Generates 53 percent of Canada's biotechnology revenue Revenues of $1.6 bn (CDN $2.2 bn) in 2003 Pharma 16,250 employees Recorded sales of approximately $5.5 bn (CDN $6.7 bn) in 2005 Has key operations by global pharmaceutical giants such as GlaxoSmithKline, AstraZeneca and Eli Lilly Pharmaceutical R&D expenditures in Ontario doubled in the last decade to nearly $480 mn in 2002 Home to over 50 percent of Canada's pharmaceutical companies The above discoveries were the outcomes of the initiatives taken at university labs and research institutes in the region. These historic discoveries made in Ontario are today helping in the fight against cystic fibrosis, epilepsy, breast cancer, and Alzheimer's disease. This spirit has imbued researchers with a vision that extends far beyond today. The research is not restricted to university labs. There are many spin- offs of the varsity departments. As Dr Tim McTiernan, Executive Director, Innovations, University of Toronto, with six Nobel Prizes to its credit, says, "With 3,000 employees the university has 103 spin-off companies. These enterprises are generating revenues up to $725 million. It generates $1.11 for every dollar of funding from the federal and provincial governments." The government has taken a number of initiatives to support the life sciences industry. Creation of a separate ministry for research and innovation in 2005 is an evidence of its deep commitment. Heading the newly formed ministry, the Premier (head of the provincial government) Dalton McGuinty has decided to strategically combine the province's different economic development activities to support the innovation in the region and also strengthen the economy. The positive approach to support innovation has led the provincial government to offer most attractive tax credits for research and development. Federal and provincial government incentives can reduce R&D costs of $100 to less than $41 after tax. Ontario government has invested and continues to invest in the faculty so that its scientists and research centers can continue to achieve cutting-edge results against stiff international competition. Over the next four years, $1.4 billion will be invested in R&D and commercialization efforts in Ontario. Besides supporting R&D initiatives, the government also funds Commercialization Centers, which house start-up companies that have evolved from universities, clinics, research facilities and industry. Essentially, there are three important projects. One, the new Ontario Research Fund (ORF) that will consolidate several Ontario research programs, right through 2009-10, a total of $634 million funds for ongoing and new research projects will be made available. Second, the new Cancer Research Program with the existing Ontario Cancer Research Network represents a $253 million investment until 2009-10 for coordinated and sustainable cancer research. Third, a new Research Council of Ontario will help co-ordinate public research and raise Ontario's profile as an international research center. The strong focus on commercialization opportunities in life sciences has been attracting many researchers to Ontario. Financial support enhances this orientation. Numerous government support initiatives reflect the strong commitment to commercialization. Provincially supported public-private partnerships have been developed, besides research parks, business centres and incubators. Full marks to the interest among the Ontarian investors community in the life sciences. Steve Kee, director, media and marketing, Toronto Stock Exchange (TSX) says, "The TSX is the third largest life sciences market in the world and has been supporting the life sciences companies at all the stages of development starting from pre-clinical stage. The TSX has 84 life sciences companies listed on its stock exchange and 53 venture capital companies were listed with total market capitalization of $20 billion." Ontario also offers an interdisciplinary teamwork-a cornerstone of the province's far-sighted development strategy-can be seen at work in the Toronto-based MaRS project. "MaRS is a convergence innovation center dedicated to accelerating the commercialization of new ideas and new technologies by fostering the coming together of capital, science and business. It is focused on helping Canadian innovators turn great ideas into great companies and supporting those companies as they become global market leaders," says Ross Wallace, director, corporate strategy, MaRS Discovery District. He added, "MaRS connects the international partners in three distinct ways as gateway (helping Canadian businesses, researchers and entrepreneurs to connect with global opportunities), facilitator (helping all three levels of government link to global partners) and collaborator (creating institutional alliances to open new communication channels and share best practices)." Sandra Pupatello, Minister, Economic Development and Trade adds, "The MaRS Discovery District is a North American hub where capital, science and business converge to turn the best Ontario ideas - medical treatments and cures, bio products and technologies - into reality." Besides research Fostering commercialization of research Government initiatives reflect commitment to commercialization. Provincially supported public/ private partnerships have been developed, besides research parks, business centres and incubators. The Ontario Innovation Corridor (OIC), which stretches from Canada's capital, Ottawa in the eastern part of the province, to Windsor in the southwest and into Northern Ontario, owes its genesis to provincial government support. Home to more than 60 research centers, several with global reputations such as the Ottawa Health Research Institute, the Hospital for Sick Children and the Samuel Lunenfeld Research Institute, and five bioscience incubators. Thunder Bay region in the province's northeast is among the most important life sciences clusters. OIC fostered by Regional Innovation Networks that promote the transfer of technology and help create partnerships with industry in each cluster area. Eleven regional life sciences clusters currently make up Ontario's innovation corridor. Ontario Centers of Excellence (OCE) Inc., foster cooperation on joint projects between universities and industry to move innovative products and technologies from the lab to the marketplace. A total of $171 million is being invested over five years in OCE. Commercialization Centers house start-up companies that have evolved from universities, clinics, research facilities and industry. Research activities in Ontario are focused mainly on cancer, cardiology, diabetes and neurosciences. The talented human capital matters a lot in research. Hence the provincial government has nurtured $6.2 billion of historical investments in post-secondary education to ensure that the students will be able to lead the businesses to prosperity for years to come. "A lot of these investments are geared towards giving Ontario's students the opportunity to master their trade of choice through hands-on apprenticeship programs," says Harinder Takhar, Minister of Small Business and Entrepreneurship. "More over Ontario, an economic engine of Canada, the nation's financial and manufacturing center, is a welcoming place where ideas, innovation and talented people thrive," says John Langley, Assistant Deputy Minister (Acting), Investment and Trade Division, Ministry of Economic Development and Trade. Ontario government is the first provincial government to introduce legislation to help internationally trained professionals work in their field. This is an advantage the province has, which allows Ontario's small and medium-sized businesses to get the best workers from around the worldâ€“and compete at a higher-level in the global economy. There are, in all about 340,000 small and medium-sized enterprises province-wide that make up 99 percent of the business in this province. Regional strengths North Bay â€“ Forestry Biotech & Biochemicals Ottawa â€“ Bioproducts & Pharma Kingston â€“ Biomedical Toronto â€“ Biomedical, Bioinformatics & Pharma Hamilton â€“ Biomedical & Clinical trials Mississauga â€“ Biomedical & Pharma Sarnia â€“ Biochemicals London â€“ Biomedical & Agribiotech Guelph/ Waterloo - Agribiotech & Bioinformatics Sault Ste Marie â€“ Forestry biotech Thunder Bay â€“ Forestry biotech Sudbury â€“ Biomining   Ontario also offers a 4.4 percent advantage over the US in pharma manufacturing, clinical trials 16 percent and biomedical R&D about 10.1 percent. The healthcare system reduces employer costs by up to 30 per cent compared to the US. The data generated from Ontario clinical trials is recognized by the US and EU authorities and the costs for phase II & III trials are lower than in the US. And also it has large multi- ethnic population. It has over 60 public and private institutions with over 10,000 researchers and well-established public and private CROs. Ontario offers whole a lot of opportunities for biotech companies for strategic alliances with R&D institutions and companies and listing in Toronto stock and venture exchanges. These facts attracted many leading global pharma and biotech players to settle in Ontario, Canada's economic powerhouse. It is testimony to its secure position as one of the key life sciences locations in North America. Among these companies are GlaxoSmithKline, Amgen, AstraZeneca, Bayer, Baxter Corporation, Biogen, Boehringer Ingelheim, Eli Lilly, Novartis, Novopharm, Pfizer, Sanofi Pasteur, Biovail Corporation, GE Medical Systems, and Johnson & Johnson Medical Products. Even Indian companies like Nicholas Piramal, GangaGen and Ranbaxy have their presence in Ontario. The secret behind the success of life sciences companies in Ontario is mainly due to interdisciplinary research, close contacts between universities and industry, and the ability to attract qualified workers and investors. Narayan Kulkarni in Toronto (The writer's visit to Canada was sponsored by Ontario government)   ]]> <![CDATA[Rabirix to tackle rabies in India]]> https://biospectrumindia.com/news/95/6511/rabirix-to-tackle-rabies-in-india.html https://biospectrumindia.com/news/95/6511/rabirix-to-tackle-rabies-in-india.html Wed, 10 Jan 2007 11:33:00 +0530 Rabirix to tackle rabies in India Rabirix to tackle rabies in India With the launch of Rabirix by Bharat Biotech, the acute shortage of rabies vaccine may soon be history Currently, the severe shortage of anti-rabies vaccine in the country results in nearly 80 deaths per day. The scenario should hopefully improve with the recent launch of a vero cell-based rabies vaccine-Rabirix by Bharat Biotech International Ltd (BBIL). Indigenously developed by BBIL, the vaccine is indicated for both prophylactic (pre-bite) and therapeutic (post-bite) treatments. Rabirix is a lyophilized vero cell-based rabies vaccine (PVRV), which is chromatographically purified to reduce cellular DNA content and foreign protein content. The vaccine has proven to be well tolerated with minimal or no side effects. Sharing details about project, Dr Krishna Ella, CMD, Bharat Biotech, said, "Presently, the rate of deaths occurring due to rabies is very high and these include a large number of children under the age of 15 years. Unfortunately most of these incidences are taking place in the urban slums or rural areas. Seeing their magnitude, I realized that the supply of the rabies vaccine is still a big problem in the country and decided to take the challenge head on." The problem with rabies is that there is no chemical drug to treat or save the patients unlike other diseases; hence death is certain without a vaccine. It is an acute viral encephalitis transmitted from an infected animal to human by exposure to saliva. Human infection with rabies is nearly always secondary to animal bite, with dog being the major reservoir for human rabies. Once clinical symptoms have occurred, the disease is almost invariably fatal. The project was launched four years back with an investment of Rs 27 crore. "For developing a vaccine, we first needed a good validated virus strain, and that is where the Centre for Disease Control (CDC) came to our help and assisted us in getting the required strain," informed Ella. The virus strain for developing the vaccine was obtained from the CDC in Atlanta, USA. Secondly, the company did not want to use roller bottles or an egg-based vaccine development strategy. Instead they decided to use a cell culture based approach. "The making of this vaccine has been an innovative process development exercise. There were many challenges, for instance, going for a cell culture based innovative formulation, stabilizing the protein, etc." The required vero cells, confirming to the necessary US FDA standards, for the vaccine development were procured from a US-based company. Post the vaccine formulation, the clinical trials were conducted. The immune sera samples from Phase III clinical trials were analyzed for the vaccine's efficacy at the National Institute of Virology in Pune. The trials showed that Rabirix is at par with the existing vaccines available in the market. Launching the vaccine at Hyderabad, Julie Gerberding, director, CDC Atlanta, said, "The development and commercialization of Rabirix in collaboration between the Centers for Disease Control and Prevention (CDC Atlanta) and Bharat Biotech is a great example of how public-private partnership entities in the US and India have joined forces to address public health concerns of the developing world." Currently, four million people are exposed to the rabies virus worldwide every year and 60,000 people fall victim to it. In India three million people undergo anti-rabies treatment and 30,000 deaths are reported annually, which accounts for 50 percent of mortality from rabies worldwide. "We have tried to look more from a social angle; our aim is to ensure that not a single child dies due to rabies in India." According to Ella, Rabirix would be 30 percent cheaper compared to the existing vaccines in India and the company is planning to adopt two different price strategies for the private and government sector. Currently imported vaccines dominate the market and their prices range between Rs 360 and Rs 380 per dose. At present, poor people cannot afford to buy vaccines, which cost around Rs 1,500 ($32) for a full course from private hospitals and chemists. The domestic market size for anti-rabies vaccine is estimated to be Rs 400 crore, while the export market is about Rs 1,500 crore. Although the vaccine has great export potential, Ella stressed that they would first look at the Indian requirement and demand. "Initially the focus of the vaccine will be on India, especially on the rural healthcare system. We need an innovative distribution mechanism to reach the masses," he said. Rolly Dureha   ]]> <![CDATA[The long wait for NBRA]]> https://biospectrumindia.com/news/95/1700/the-long-wait-for-nbra.html https://biospectrumindia.com/news/95/1700/the-long-wait-for-nbra.html Wed, 10 Jan 2007 11:26:00 +0530 The long wait for NBRA The long wait for NBRA With rapid growth in R&D efforts in biotechnology, a statutory and autonomous National Biotechnology Regulatory Authority (NBRA) is the need of the hour. The recommendations for the same had been made quite some time back but it remains to be seen how swiftly will it be formed. The Task Force on Application of Biotechnology in Agriculture, under the chairmanship of Dr MS Swaminathan, submitted its report in June 2004. One of the most important recommendations of the Task Force was on the setting up of a National Biotechnology Regulatory Authority (NBRA) for promotion and regulation of application of biotechnology in agriculture. According to the report, the NBRA should be an apex body, which would put an end to the multiplicity of overseers. The Authority would have a common chair but two separate wings-one dealing with food and agricultural biotechnology and the other with medical and pharma biotech, the report said. After the inter-ministerial consultations on the recommendations of the MS Swaminathan Task Force report, the Department of Agriculture and Cooperation had identified some areas for prioritized action and subsequently, the note for setting up the NBRA was mooted in the Cabinet by the Ministry of Agriculture. A meeting of the Committee of Secretaries (COS) was held in this regard in March this year. Even the Indian President, Dr APJ Abdul Kalam, reiterated the present government's commitment to the setting up of the NBRA. Addressing a joint session of the Parliament in February this year, he said, "My government is in the process of setting up of a National Biotechnology Regulatory Authority which will be the nodal authority for release, import and post-release monitoring of GM crops and seeds." Kalam noted that quality control is an important issue, and the National Biotechnology Regulatory Authority will boost and strengthen the GM seed testing laboratories. Later in August, this year, while replying to a question on the status of NBRA, in the Lok Sabha, Kapil Sibal, Union Minister for Science and Technology, confirmed that the government will set up a National Bio-technology Regulatory Authority. Updating the members on the situation, he stated "The Ministry of Agriculture, Department of Agriculture & Cooperation had submitted a Note for the Cabinet for setting up of National Biotechnology Regulatory Authority (NBRA) and has resubmitted revised Note for the Cabinet after the proposal was considered by the Committee of Secretaries (COS). The Government department to serve as a nodal Ministry will be decided by the Union Cabinet. If the proposal is approved by the Cabinet, the Department of Agriculture and Cooperation would send the whole report to the identified Department for setting up of NBRA and taking follow up action." "Thus no specific time frame (for setting up the NBRA) can be committed at this moment," he replied when asked about the time by which it is likely to come into existence. Making the case for NBRA stronger, the Department of Biotechnology has also made the recommendation for setting the Authority in the National Biotechnology Draft Strategy Report which is currently in the Cabinet for approval. According to Dr Bhan, "I believe that the NBRA proposal will be considered by the Cabinet in the near future." Giving the rationale behind the NBRA, Prof MS Swaminathan said, "In order to facilitate the Second Green Revolution, the Government should do what I recommended more than two years ago in my report on agricultural biotechnology. First, we must have a credible mechanism accepted by the public, by the media, a transparent, credible mechanism of risk benefit analysis-the social cost and the social benefit. Here the social cost includes the environment and the health. Hence I had recommended, like our election commission, an autonomous biotechnology regulatory authority, which will be run professionally by leading professionals, that is, a member recommended as chairperson who will be common for two wings-medical and pharmaceutical biotechnology and agricultural and veterinary biotechnology. There could be two vice-chairs. The overall chairman should be a leading authority on biosafety, bioethics and should not be appointed on an ad hoc basis." But unfortunately, the setting up of the NBRA has essentially become a turf war, as to who will control the Authority. "The idea of an autonomous body is that it should not be controlled," said Prof Swaminathan while expressing his disappointment at the enormous delay. The setting up of an autonomous and professionally-led regulator is essential for deriving the full benefits from this fast-growing area of science and the need of the hour is that the government should quickly act on it. Rolly Dureha   ]]> <![CDATA[Biotech products in the pipeline]]> https://biospectrumindia.com/news/95/1117/biotech-products-in-the-pipeline.html https://biospectrumindia.com/news/95/1117/biotech-products-in-the-pipeline.html Wed, 10 Jan 2007 11:23:00 +0530 Biotech products in the pipeline Biotech products in the pipeline Sweet potato that resists disease A new biotech sweet potato is being field tested in Kenya has built-in resistance to a devastating virus that consumes more than three-fourths of the annual harvest in Kenya. The new sweet potato could double yields, which could represent another step forward in the fight against global hunger. Rice that can withstand droughts A new variety of biotech rice developed by Cornell University researchers can withstand drought and thrive in marginal soil. Taking a clue from the hardy resurrection plant, a desert moss that can slow its activity down to near zero when water's scarce and then spring back to life with the arrival of water, the Cornell researchers took the genes that synthesize trehalose, a simple sugar that is produced naturally in a wide variety of organisms, including the resurrection plant and inserted it into rice. Citrus trees to help preserve citrus industry Biotech citrus trees now in development at Texas A & M University could help protect the Texas citrus industry from the brown citrus aphid that has already destroyed millions of citrus trees in Argentina, Brazil, Mexico and Venezuela. Currently Mirkov is carrying out field tests, authorized by the USDA, on about 100 citrus trees modified to resist CTV in different ways. Biotech papayas could aid subsistence farmers in Southeast Asia The technology that led to the creation of a new biotech papaya that is credited with saving Hawaii's industry is now being deployed to help papaya growers in many areas of the developing world, including Southeast Asia. Led by scientists from Cornell and the University of Hawaii, researchers inserted a gene that made the plants resistant to the ringspot virus similar to the way a vaccine makes people immune to disease. Tastier tomatoes to combat heart disease, cancer Researchers at the US Department of Agriculture (USDA) and the Boyce Thompson Institute for Plant Research (BTI) at Cornell University have discovered the gene one scientist calls the "Holy Grail" for understanding tomato ripening and taste. By shutting down the rin gene, USDA and BTI researchers have developed a way for tomatoes to stay on the vine longer so they develop more nutrients, color and taste. The longer a tomato stays on the vine, the more beneficial lycopene that is produced. Lycopene is an antioxidant that is believed to inhibit cancer and heart disease. In another research lab, scientists at Purdue University and the US Department of Agriculture have developed a biotech tomato that contains as much as three and a half times the level of lycopene as conventional tomatoes. New lettuce could help prevent heart disease A researcher at the National Institute of Education in Singapore has used plant biotechnology to develop a new type of lettuce that is fortified with resveratrol, the ingredient in red grapes and red wine that is believed to help prevent heart disease and cancer by increasing levels of good cholesterol and lowering levels of bad cholesterol. Scientists hope to genetically enhance other fruits and vegetables including spinach, tomatoes, cabbage, watermelons and strawberries. Healthier French fries with added starch Researchers are working to boost the starch content in potatoes so that less oil will be absorbed when they are cooked to make French fries, potato chips and other foods made from potatoes. By inserting a gene into potatoes that improves the conversion of sucrose into starch, the starch content of potatoes has been increased by between 30 and 60 percent. Heart-healthier soybean oil A new variety of soybean developed by a Nebraska researcher could make thousands of consumer products healthier, according to biotechnology experts. The enhanced soybeans have been improved so they contain more of the "good" monounsaturated fats and less polyunsaturated fats and "bad" saturated fats. Decaffeinated coffee bean plants Today, the decaf coffee you sip at your local coffee shop was decaffeinated using chemicals and solvents that strip the caffeine out of the bean. But researchers from the Research and Education Centre for Genetic Information in Nara, Japan, outlined their method for producing enhanced coffee plants that repress the caffeine-generating genes that produce caffeinated coffee beans. The enhanced beans have 70 percent less caffeine. The new beans aren't likely to make it into consumer's mugs for at least another three or four years. Plant-based vaccine to prevent cervical cancer Bananas and potatoes have been developed that contain a vaccine for Human Papillomavirus (HPV), one of the most prevalent sexually transmitted diseases and the cause of almost all cervical cancer in women. Researchers with the University of Rochester have tested varieties equipped wit h the vaccine and work is now entering the third stage of clinical evaluation. Vaccine in cherry tomatoes to fight RSV Cherry tomatoes could one day be used to deliver a vaccine to prevent Respiratory Syncytial Virus (RSV), a potentially deadly respiratory virus that often attacks children. Researchers at the University of Illinois at Urbana-Champaign, aided by some funding by the USDA, are working on a way to genetically enhance cherry tomatoes and eventually apples to administer a vaccine to prevent the disease. Source: www.whybiotech.com   ]]> <![CDATA[New Drugs]]> https://biospectrumindia.com/news/95/2857/new-drugs.html https://biospectrumindia.com/news/95/2857/new-drugs.html Wed, 10 Jan 2007 11:22:00 +0530 New Drugs New Drugs Alzhemed, Neurochem Developed by Canadian pharma major Neurochem, Alzhemed is investigational product candidate that can be used as a potential therapy for Alzheimer's. ALZHEMED acts by reducing the deposition of amyloids in the brain by binding to soluble AÃŸ peptide. In the phase I trials, Alzhemed had a dose-dependent inhibitory effect on both the deposition of cerebrovascular amyloids and on plasma concentration. Alzhemed is currently undergoing phase III trials in Europe. Gardasil, Sanofi Aventis Gardasil is being touted as the world's first vaccine against cervical cancer and other diseases caused by certain types (16, 18, 6 and 11) of the human papilloma virus (HPV). Marketed by Merck & Co., the vaccine is designed to prevent infection with HPV. Australia's government announced in late November last year that beginning 2007 they will provide this vaccination to all 12-13 year-old girls in the country. PI-88, Progen, Australia PI-88, anti-angiogenic therapeutic works against multiple cancers at an early stage. This drug attacks the growth of the original tumor and inhibits the establishment and spread of secondary tumours. Typically, anti-angiogenic therapy fights against cancerous tumors by stopping them from forming blood vessels that spread the cancer. In its phase II trials, Progen tested PI 88 for lung cancer, liver cancer, multiple myeloma and melanoma (for which PI-88 has received Orphan Drug status from the US FDA) and prostate cancer. SPP100/ Raslilez, Novartis SP 100 or Raslilez is touted as the first of a new class of renin inhibitor drugs. Renin is a circulating enzyme released in the kidney that brings about a series of biochemical events causing blood vessels to constrict. It is considered to be one of the crucial molecular triggers that lead to hypertension. Novartis has submitted Rasilez for its regulatory approval in the US in early 2006 and much recently in the European Union. MN-001, MediciNova MN-001 is a drug compound that has been shown to block a number of the inflammatory mechanisms activated by mast cell degranulation. It is also under development by MediciNova for the treatment of interstitial cystitis. The company hopes to get the final phase results by the beginning of 2007. Chantix, Pfizer Chantix is a smoking cessation product and is an alternative to bupropion (Zyban) and nicotine replacement therapy (NRT), such as nicotine patches. By acting similarly to nicotine on the brain it reduces user cravings for cigarettes and other tobacco products and may assist some patients in smoking cessation. Exubera, Pfizer & Nektar Therapeutics Exubera is the brand name of the first formulation of inhalable insulin to receive the US Food and Drug Administration (FDA) approval. It is manufactured by Pfizer in collaboration with Nektar Therapeutics and is licensed for use by both type 1 and type 2 diabetics. Exubera is considered short or rapid acting insulin.   ]]> <![CDATA[Biotech Products Launched in 2006]]> https://biospectrumindia.com/news/95/7886/biotech-products-launched-in-2006.html https://biospectrumindia.com/news/95/7886/biotech-products-launched-in-2006.html Wed, 10 Jan 2007 11:20:00 +0530 Biotech Products Launched in 2006 Biotech Products Launched in 2006 ]]> <![CDATA[BioSizzlers of 2006]]> https://biospectrumindia.com/news/95/6581/biosizzlers-of-2006.html https://biospectrumindia.com/news/95/6581/biosizzlers-of-2006.html Wed, 10 Jan 2007 11:19:00 +0530 BioSizzlers of 2006 BioSizzlers of 2006 In 2006 January, we presented a list of companies that we felt would make some significant announcements in 2006. We had not listed big and well-established companies like Biocon, Bharat Biotech, Serum Institute of India, Shantha Biotech, and Vimta Labs. These have all made headlines in 2006. The companies that we listed were those that would make a difference in the next level of India's biotech growth. Here, we present to you what has happened at the biosizzler companies. ]]> <![CDATA[Companies to watch in 2007]]> https://biospectrumindia.com/news/95/1660/companies-to-watch-in-2007.html https://biospectrumindia.com/news/95/1660/companies-to-watch-in-2007.html Wed, 10 Jan 2007 11:18:00 +0530 Companies to watch in 2007 Companies to watch in 2007 In August-September 2006, BioSpectrum carried a series of articles about the new biotech entrepreneurs. These companies have been adopting new business models and are the next set of enterprises to look out for. These are expected to bring new dynamism to the biotech industry and hence considered as companies to watch in 2007. These are some of the new establishments that we have considered. There are several established and new enterprises that are also going to do well in 2007. ]]> <![CDATA[Biotechnology industry's demands to the FM]]> https://biospectrumindia.com/news/95/1504/biotechnology-industrys-demands-to-the-fm.html https://biospectrumindia.com/news/95/1504/biotechnology-industrys-demands-to-the-fm.html Wed, 10 Jan 2007 10:42:00 +0530 Biotechnology industry Biotechnology industry's demands to the FM With the annual budget session round the corner, the biotech industry is geared up with its list for Finance Minister Chidambaram. The various industry associations like ABLE, AIBA, CII and FICCI have taken the feedback from their member companies and submitted their demands to the finance ministry. We are presenting here the comprehensive list of what the industry needs from the finance minister based on the collective recommendations made by the four industry associations (ABLE, AIBA, CII and FICCI). Duty exemption norms for imported life saving drugs and diagnostics to include components for indigenous manufacture of same There exists a serious anomaly with respect to imported and indigenous life saving drugs and diagnostics and wherein raw materials and components used by indigenous manufacturers for such products are levied customs duty and excise duty whereas the finished products are allowed to be imported duty-free. This is detrimental to indigenous manufacturing and instead encourages trading. Furthermore, it puts indigenous manufacturers at an unfair disadvantage to MNC competition. It is therefore recommended that components and raw materials used by indigenous manufacturers for the production of diagnostics and life saving drugs are exempt from Excise and Custom duty based on standard input/output norms certified by the Department of Biotechnology or alternatively duty paid on components and raw materials used in manufacture of life saving drugs be eligible for refund. Exemption on customs import duty on R&D equipment The biotechnology sector is capital intensive necessitating investment in expensive R&D infrastructure. Currently, R&D equipment as specified in List 27 A and List 28 (Custom Notification No: 26/2003 dated 01.03.2003 by DSIR recognized Research Laboratories) are exempt from customs duty. It is recommended that this list be expanded to cover some more additional essential equipment. In addition, due to the ever-changing requirement of new types of equipment, it is recommended that additional R&D equipment not covered in List 27A and List 28 be permitted to be imported duty free based on DSIR certification. Further, though customs duty levied on items falling under List 28 attract Nil basic Custom duty but are liable for payment of additional custom duty of 16 percent, Educational Cess 2 percent, Cumulative Educational Cess 2 percent (some equipment are exempt under Not. 69/04) and Additional Duty of 4 percent which totals to 21.47 percent on the CIF value of the equipment imported. The purpose of exemption of basic duty to equipment for research is to promote investment in basic research but the same is being nullified by subjecting it to additional duty of 16 percent. Second, there is exemption against the additional customs duty applicable to only Public Funded Research Organizations or Non Profit Research Organizations where they have to pay only five percent Custom Duty on Equipment for Research (under Not. No. 51/96). With a strong need to create equality, the customs duty exemption on capital goods and raw materials should be exempted to all biotechnology companies engaged in R&D, irrespective of the fact whether they are funded by the Government or private funded. New companies should be permitted to import R&D equipment at nil duty to the extent of Rs 25 crore, as certified by the DBT. The restriction of recognition by DSIR for new companies should be waived for a period of five years from the date of incorporation. Duty refund/drawback for R&D consumables The import of R&D consumables, reference standards and reference books are subject to the full incidence of import duties as no countervailing duty credit is available on R&D consumables. To encourage more companies to set up research labs, it is recommended that import of R&D consumables, reference standards and reference books be made eligible for refund/duty drawback or duty credit based on DSIR certification. The government may also consider providing relief to recognized biotech, pharmaceutical and clinical research companies by giving a blanket permission, of say up to Rs 1 crore per annum, for import of laboratory consumables, which can be certified as non-hazardous, if required. Additional items to be included in the list of capital goods under List 27 A and List 28 List of equipment used in biotech industry Production Animal Cell Culture Fermenter Automatic closing machine Automatic filling machine Automatic labeling machine Automatic vial washing machine Chromatography Columns Depyrogenation oven Explosion Proof Refrigerated Centrifuge Fermenter System including controls and automation High Pressure Homogeniser HPLC High Speed Centrifuges Homogeniser (Low pressure) Instrumentation like pH probe, DO2 probe, Mass Flow meter, Methanol sensor, pressure transmitters, temperature transmitters, etc. Isolators Lot printing machine Low Pressure Chromatography System Lyophilliser / Freeze Drier Mobile laminar flow cabinet Refrigerated Centrifuges Reverse Phase High Pressure Liquid Chromatography System Revision tables Sterile Cartridge filters Tangential Flow Filtration System (including Microfiltration, Ultrafiltration, Diafiltration) Tubular Centrifuge Laboratory Air Sampler Anaerobiosis Jar Beta Counter Cell Roll Colony Counter Double Door Class 100 oven Filter Integrity Test Equipment Automatic Gas Burner Flow Cytometer FPLC chromatography Gamma Counter Gas Chromatography system Bio-chemical Analyser High precision analytical balances HPLC Systems Hybridization Oven Image Analysis System Inverted Microscope Kjeldahl System Low temperature incubators (-20 deg.C. and below) Micro-Hematocrit centrifuge with reader Microtome Phastsystem and Phastimagen Platform Rocker Refractrometer TOC Analyser Tube Rotator Vacuum Concentrator Vascular Shaker Raw Materials used in the manufacture of life saving drugs for which duty exemption is sought Acetonitrile Dimethyl formamide Chromatography resin D- Biotin Ethanol Ethanol (Absolute alcohol) L -Threonine methyl ester HCL Cell Culture media Pluronic F68 Sarkosyl Sod bi carbonate Antifoam Trypsin Tween 80 Yeast extract Tax holiday The tax holiday scheme is nearing completion (10 year scheme expires on March 31, 2007) and the current provision for a 150 percent weighted tax deduction, u/s 35 (2AB) for R&D expenditure incurred by DSIR recognized research laboratories, has been a great boon to incremental R&D investment. With the new challenges imposed by the WTO-TRIPS regime, R&D investments will need to be augmented even further. The weighted deduction be increased to 200 percent and the scheme be extended for a further period of eight years i.e. up to March 31, 2015 to encourage a greater plough back into R&D. Alternatively, DSIR recognized Research Laboratories could be made eligible to deduct from Corporate Income Taxes an amount equivalent to 20 percent of Qualified Research Expenditure, similar to the practice followed in the US. Further, it is important to note that the provisions for weighted deduction u/s 35 (2AB) does not cover agribiotech companies. Given the increasing importance of research on agribiotechnology, it is recommended that the expenditure pertaining to this segment be also included in the ambit. The weighted deduction under section 35(2AB) should be extended to investment made in land and buildings for dedicated research facilities. Inclusion of international patent filing costs u/s 35(2AB) The development of capabilities for the effective management of Intellectual Property (IP) is an important element in securing the benefits of public and private sector research in biotechnology. In this context, filing of patents both in India and abroad is critical. The expenses for filing patents especially outside India are prohibitive and a major barrier to effective IP management in the country. Also whilst expenses incurred with filing of patents in India is eligible for weighted deduction, similar benefit is not provided for expenses incurred with regard to filing patents outside India. As IPR creation is a pre-requisite for exports to the regulated markets, it is recommended that expenditure incurred with regard to filing patents outside India be also eligible for weighted deduction U/S 35 (2AB). Recognition of anti-cancer drugs as life saving drugs The cost of cancer treatment in India is very high. Further, there are not many effective drugs available in the market. Anti-cancer drugs form a substantial cost of the treatment of cancer patients. The impact of customs duty at the rate of 12.5 percent, Excise/CVD at the rate of 16.32 percent, education cess at the rate of 2 percent and additional duty on Customs at the rate of 4 percent would result in a 36.74 percent increase in the price of the drugs, thereby increasing the cost of treatment substantially. It is requested that an exemption from customs duty on the import of anti-cancer drug and from excise duty on the manufacture of the drug, be granted by including such anti-cancer drugs under List No. 4 of item 83 of the Customs notification No 21/ 2002, and under list 3 of item No 54 of the Excise tariff Notification No. 4/2006. Exemption of withholding tax for technology transfer and licensing in biotech For the Indian biotech sector to flourish it is important that Indian companies enter into collaborative research programs and import/license platform technologies thereby permitting Indian companies to expand their existing skill base and shorten timelines from research to commercialization. The existing requirement for withholding tax for technology transfer results in increased cost of import of technology. To facilitate Indian companies to acquire more technology, the import of technology by the biotech sector be exempt from Withholding Tax for a period up to 2010. Excise duty on diagnostic kits for infectious diseases Presently, diagnostic kits used for detection of HIV antibodies are exempt from customs duty under List 4 and CVD/CED under the Central Excise Act. It is recommended that diagnostic kits for other infectious diseases such as hepatitis C, malaria, tuberculosis, etc. also exempt from customs duty and CVD/CED as it falls with the category of life saving drugs. Concessions to biotech companies located in biotech parks The changes in Foreign Trade Policy permits biotech companies located in state-sponsored biotech parks to avail: Duty free import of equipment, instruments and consumables; and Tax holiday under Section 10A/ 10B of the Income Tax Act. However, these benefits are only available to 100 percent Export Oriented Biotech Units and therefore similar to the benefits enjoyed by 100 percent EOUs in all other Industrial sectors. Since the biotech companies are in a nascent stage it is not possible for these companies to commit to export obligations. To facilitate the growth of the sector it is recommended that the requirement for export of products be waived and the concessions be also extended to companies supplying Biotech products to the domestic sector. Expansion of list of capital goods under List 27 A and 28 The existing schemes be amended to cover: Expansion of the List of Equipment provided in List 27A and List 28 to cover additional equipment required for manufacture of biotech products and new companies be permitted to import equipment at nil duty to the extent of 25 percent of the project cost, as certified by the DBT/Recognized Financial Institution. The restriction of 25 percent of FOB value of exports and recognition by DSIR should be waived for new companies for a period of 5 years from date of incorporation. Inclusion of clinical trials as "technical testing or analysis services" under the Export of Service Rules, 2004 Expenditure incurred on clinical trials by companies is currently not accepted as an expense to be included for weighted tax deduction at the rate of 150 percent under section 35 (2AB) of Income Tax Act, 1961. It is submitted that the tax benefit should also be extended to expenditure incurred on clinical trials for all companies. Since expenditure incurred on scientific research is allowed; there is no reason why it cannot be extended to clinical trials as well. Second, service tax was imposed on clinical trials for testing of drugs and formulations this year. Accordingly, fees charged for clinical trial services in India would now attract service tax at the rate of 12.24 percent (including education cess) under the category 'technical testing and analysis services' in the hands of the Indian Clinical Research Organization (CRO). Further, service tax would also to be liable on pass through costs of the Indian CRO (such as investigator fees, transportation etc). Thus the service tax would be an additional high impact cost to the nascent Indian clinical trial industry and a huge deterrent, especially at a stage where India is facing increased cost competitiveness from countries in Latin America, Easter Europe and China. It is therefore suggested that CRO industry be exempted from the levy of Service Tax on all its activities including clinical trials to encourage it. Waiver of requirement of filing form ER-5 & ER-6 under Cenvat Credit Rules 2004 The present requirement of submission of detailed returns on input-output norms for each product requires biotech companies to reveal sensitive information about inputs used in the manufacture of biotech products. As this information is confidential and will reveal proprietary information it is recommended that biotech companies be exempt from this requirement. Implementation of service tax rebate/refund notifications Currently, exporters of taxable services by the biotech industry are eligible for rebate/refunds of service tax and cess paid on input services used in providing taxable service exported. However, although the applications for the above rebates/refunds are piling up with the department, so far, no rebates/refunds have been granted to the export service providers. It is requested that the refund/rebate sanctioning authority be suitably instructed to adhere to the instructions contained in the circular 828/5/2006-CX, and grant the initial refunds/rebate within 15 days of filing the duly completed refund/rebate application. In general it is requested that the officers be instructed to process the refund/rebate claims within a reasonable period of time and to grant the refunds/rebates, on merits. Two year moratorium on obtaining price approval for products under price control It is recommended that biotech products manufactured in India be given a two-year moratorium from price control under NPPA (National Pharmaceutical Pricing Authority) to provide for sufficient time to scale up production and streamline costs. The present requirement for approval from NPPA prior to launch leads to substantial delay in launch of the product. It is also recommended that R&D expenditure incurred on biotech products be permitted for amortization in computing costs for the purposes of price fixation. Provision of a central fund of Rs 200 crore to compensate states that provide subsidy on approved transgenic seeds The deployment and growth of Bt cotton seeds in the last three years has unequivocally demonstrated the benefits of transgenic technology in Indian Agriculture. The transgenic seeds today are priced at about 3-4 times the price of the non-transgenic counterpart, due to the investments in developing/in licensing the technology and the high regulatory costs prior to its commercialization. Though the high seed cost is more than compensated by the tangible benefits that the technology provides, it makes the technology unaffordable, at least in the initial years to the small and subsistence farmers of this country. Subsidizing the seed cost, at least partially, will go a long way in the penetration of the technology among small farmers, who incidentally will stand to gain the most from such technologies. Further, subsidy for the approved varieties of transgenic seeds will also effectively curb the menace of unapproved and fake transgenic seeds, which is rampant in the country today. Priority sector lending for biotech Biotech entrepreneurs have great difficulty in obtaining bank financing as this sector has a high risk profile with long gestational time lines which are not conducive to lending. Currently, lending to the agri-business sector as well as to venture funds is categorized as priority sector lending. Whilst agribiotech can avail of such lending, the rest of the sector which is as risk prone is unable to access such finance. It is therefore recommended that lending to the biotechnology sector be categorized as priority sector lending. This step will surely spur the biotech business in the country. Budgetary allocation for setting up arbitration council or quasi judicial tribunals to address IPR disputes With India's commitment to TRIPS agreement under WTO and introduction of product patent regime from January 1, 2005 it has become imperative to enforce the same with the same spirit. However given the stress under which Indian judicial system operates and backlog of cases, industry feels that existing system would not be capable to handle the IPR related disputes efficiently. Additionally, the judges may not be fully versed with the technical details of IPR related issues and there is need to have specially trained judicial personnel and courts to showcase India as next hub for contract research, clinical trials and contract manufacturing in biotechnology space. Budgetary allocation for setting up an internationally accepted accreditation agency For India to take leap in the biotechnology space there is need to offer quality in both manufacturing as well as services domain. This requires setting up of an internationally accepted accreditation agency which can set standards, protocols and act as gatekeeper for producing world-quality products / services. The agency can also liaison with internationally bodies of repute such as USFDA, BP, TGA etc. for setting up guidelines for its functioning/operations. Customs duty exemption on biopesticides Industry also recommends that biopesticides and biocontrol agents should be exempted from levy of both the custom duty and excise duty in the next budget. Currently the excise duty rate being charged on them is 16 percent, which is the same as on hazardous chemicals. To promote the use of eco-friendly, non hazardous and biodegradable biopesticides the excise and custom duties should be withdrawn. In addition, the biopesticides and biocontrol agents should be exempted from levy of VAT (Value Added Tax). Concessions in the capital gains tax for investors in dedicated biotech venture capital funds In order to encourage setting up of dedicated biotech venture capital funds in the private sector, a modification in the current capital gains tax is needed. This will not only encourage investments by institutions into such venture funds but will also catalyze significant capital from high net worth individuals (HNIs) and pharmaceutical companies into the biotech sector. A capital gains tax of zero for investors in venture capital funds dedicated for investments in biotech companies is recommended. To qualify for this benefit such venture capital funds should be registered with SEBI. Removal of current restriction for Foreign Direct Investments in biotech sector Whilst pharma and most other companies are permitted 100 percent FDI under the automatic route, biotech companies manufacturing recombinant products require FIPB approval for any foreign direct investment (FDI). It is recommended that since there is a strong regulatory system in place evaluating/approving the manufacture of recombinant products, 100 percent FDI be also permitted in the biotech sector. Clarification in excise tariff in consonance with HSN It is requested that an appropriate note be incorporated in the Chapter 30 of Central Excise Tariff (CET) to avoid confusion/misinterpretation in regard to classification of "Diagnostic Kits" and remove the items "HIV Diagnostic Kits" and "Pregnancy Diagnostic Kits" from Chapter 38.22 of CET. Technical expertise at airports There is a lack of technical expertise at the airports and ports to handle the biological materials. Customs officials may be updated regularly with the new policies on issues related to handling of biological materials. The registry of chemicals / biochemical of the customs database at the ports /airports may be updated. Duty exemption for biofuel and ethanol production Bio-fuels may be used as an alternative environmentally friendly fuel in the future. The government may consider extending tax incentives like excise and import duty exemption to promote use of bio-diesel and ethanol in auto fuels in order to slash India's oil dependence. It is proposed that the investments made by corporates on jatropha plantations, maize and soybean plantation for ethanol production should be given tax holiday for a period of 10 years from the beginning of the oil/ethanol production. In addition, there should be no import duty on machinery and equipments used for esterification of Jatropha oil and for ethanol production from maize and soybean.   ]]> <![CDATA[Research a lucrative career option]]> https://biospectrumindia.com/news/95/1262/research-a-lucrative-career-option.html https://biospectrumindia.com/news/95/1262/research-a-lucrative-career-option.html Wed, 10 Jan 2007 10:41:00 +0530 Research a lucrative career option Research a lucrative career option Biotechnology is a research-oriented field and there is a demand for researchers, scientists and trained technicians with excellent lab skills. Research in the field of life science could eventually prove to be a lucrative and a challenging career option. At the post-graduate level scholarships are available to undertake post graduate course in biotechnology. An all India examination is conducted and the scholarships given to around 1200 qualifying students. Scholarships are available at the doctoral level too. Apart from the CSIR-UGC, the DBT also has a provision for 100 fellowships for PhD courses. Fellowships are also available at post-doctoral level by all the funding agencies. The working scientist can write research proposals and submit them to various agencies for funding. With the government budget on science and technology development increasing every year, the probability of getting a project funded through a central funding agency has increased. Younger scientists are encouraged to write research proposal. Researchers/scientists can then apply for associateship to undergo advanced training in the best research organization anywhere in the world. Under the Biotechnology Overseas Associateship Award sponsored by the Department of Biotechnology (details available on website dbtindia.nic.in), all expenses are paid by the government including the travel, stipend and a preparatory allowance The number of associateships are 100. Another possible avenue of getting associateship is under the specialized training in niche area program of the Department (details available on website dbtindia.nic.in) A scientist with innovative idea which could be taken forward and developed into a technology, can now collaborate with an industry and apply for loan/grants-in-aid from the Department of Biotechnology under its Small Business Innovative Research Initiative scheme (SBIRI) and under the CSIR New Millenium Indian Technology Leadership Initiative scheme (NMITLI) and other such schemes like Pharmaceutical Research and Development Support Fund (PRDSF) of DST, TDB and TIFAC. Under the Centre of Excellence scheme funded by the Department of Biotechnology, a scientist with a record of scientific excellence can build a team around himself and pursue his area of scientific focus towards excellence under this scheme. R&D within private companies As already mentioned, the biotech companies have an increasing demand for researchers in biotechnology. With the implementation of TRIPS, out sourcing of research or contract research to India is going to be the call of the day. The Indian industry and MNCs would increasingly be seeking the skilled scientific expertise of the country. Research in biotechnology and all related fields would be the career of the future and options are available with mutinationals, large public and private sector corporations, pharma majors, research institutions, laboratories and organizations both government and private in the country. Biotechnology business managers: The biotechnology industry is a complex industry requiring a strong scientific R&D base. It is time and money intensive. Even so the biotech industry has been a major success story. There are career possibilities to be tapped. Pune University and Amity Institute have introduced MBA in biotechnology. Technology transfer personnel: In the coming years, technology transfer expertise would be much sought after by the public institutions as well as the private industry. Not available within the country but a course abroad would make one most sought after within the country. Patent attorney: In a country where the number of patents filed are amongst the lowest in the world, the disposal time taken is the highest. The country needs biologists with knowledge of Intellectual Property Right (IPR) and patent laws for streamlining the patent process. Clinical researchers: Conducting clinical research in India costs 1/7th the cost in western countries and India is going to be the destination for carrying out clinical trials. Consequently expert clinical researchers would be a requirement. Bioinformatics: Bioinformatics would be able to take off only when we have skilled human resource in information technology with a sound knowledge of biological sciences. Social scientists: A major challenge of biotechnology is creating social awareness, be it for genetically modified organisms, transgenics, vaccine development, clinical research, bioethical issues or biosafety concerns. Social scientists would be required to fill this gap. Teaching opportunities: With private education aggressively entering market, especially in all areas of biotechnology, teaching would most likely emerge as the most well paid job in the near future. To meet the challenges of a growing industry, scientific research and development opportunities, it is crucial to provide impetus to education and training in science and technology. IT is essential to evolve an educational system, which is moulded to meet the challenges, allowing the pursuit of research and monitoring the esteem and position of science in society. There is a need for teaching organizations to diversify by introducing options, which allow students to choose and exploit the potential of a relatively new but fast expanding industry.   Dr Shailja Vaidya Gupta Joint Director, DBT e-mail: shailja@dbt.nic.in   ]]> <![CDATA[Biotechnology teaching and career opportunities]]> https://biospectrumindia.com/news/95/2561/biotechnology-teaching-and-career-opportunities.html https://biospectrumindia.com/news/95/2561/biotechnology-teaching-and-career-opportunities.html Wed, 10 Jan 2007 10:39:00 +0530 Biotechnology teaching and career opportunities Biotechnology teaching and career opportunities This article by Dr. Suman Govil and Shubhlata Sharma throws light on the various biotech courses, job openings and immense scope that this new sunrise industry has to offer. Biotechnology has tremendous potential in improving human and animal health, increasing agricultural productivity and providing a safe and clean environment. Realizing this, the Government of India started a multi-agency National Biotechnology Board comprising the UGC, ICMR, CSIR and DST in 1982, which was upgraded to a full-fledged department in 1986 to give the much-desired impetus to this area. Biotechnology is a multi-disciplinary and rapidly advancing area and well-trained manpower is a pre-requisite for meaningful R&D and production in biotechnology. India can take pride in being one of the first few countries in the world to initiate an integrated program of human resource development in biotechnology comprising post graduate teaching programs, short-term training courses for upgrading skills of mid-career scientists, faculty involved in undergraduate and post graduate teaching, training in leading overseas laboratories, in gap areas where expertise does not exist in the country. The department took a well-informed decision not to start undergraduate teaching in biotechnology as it is a highly specialized, laboratory-intensive course. The post graduate courses were initiated in 1985 in six universities in close collaboration with the University Grants Commission, ICAR and the Department of Ocean Development. These programs were conceived as collaborative, inter-departmental and inter-institutional programs and initiated on the basis of core strength in the area of faculty, existing infrastructural facilities, R&D grants on competitive funding basis and nearby institutions engaged in biotechnology R&D. These programs served a catalytic role and many other institutes initiated these programs. The department provided liberal grants for the establishment of specialized laboratory infrastructure, equipment, recurring grants for consumables, studentship, books and journals, travel, visiting faculty, contingency etc. India is a vast country and keeping in mind, the demand for trained manpower in specific areas and regional aspirations, these programs have been expanded in over 61 universities in general, medical, agricultural, marine, veterinary, industrial and pharmaceutical biotechnology. The department is considering initiating new programs in food and nutrition, clinical pharmacology and product development, bio-instruments and biomedical standards, bioenterprise management and financing and regulatory affairs. Curricula To maintain uniformity and minimum standards of education, model course curricula have been developed by organizing brainstorming sessions. These curricula are adopted by all teaching institutions with minor institutional variations based on in-house faculty strength in specific areas. The curricula revision exercise is undertaken periodically to keep pace with latest developments and to incorporate. To keep abreast with the latest developments in the rapidly advancing area of biotechnology, faculty upgradation programs in leading national laboratories with emphasis on hands-on training have been developed for college teachers involved in undergraduate education and faculty associated with postgraduate teaching. There is a provision for training in overseas laboratories also. These teaching programs are continuously monitored by an in-house advisory committee with outside expert members from academia and industry and DBT representative, annual meeting of course coordinators and DBTâ€“UGC joint task force on HRD to ensure minimum and uniform teaching standards. Admission criteria and procedure To compete in the global market for jobs, it is important to select bright and meritorious candidates and impart best training. The selection of students is made on an all India basis through Common Entrance Test (CET), joint entrance test conducted by IIT or tests conducted by respective universities. The courses are very popular and admission procedure is highly stringent which is evident from the fact that approximately 21,000 students competed for 428 seats of MSc General Biotechnology in the JNU Common Entrance Test during 2006-07. The candidates with bachelor's degree under 10+2+3 pattern of education in physical, biological, agricultural, veterinary and fishery sciences, pharmacy, engineering/technology, four years BS (Physician Assistant course) or MBBS or BDS are eligible. Curriculum outline Intensive theoretical and practical training is offered to all MSc/MTech students. The details of courses in different streams are given below: MSc (General) Biotechnology: Cell biology, bio-molecules, microbial physiology and genetics, computer applications and biostatistics, molecular biology, macromolecules and basic enzymology, biology of the immune system, biophysical chemistry, animal biotechnology, genetic engineering, plant biotechnology, bioprocess engineering and technology, genomics and functional genomics and project in third and fourth semester. MSc (Agriculture) Biotechnology Major courses: Molecular genetics and cell biology, techniques in cell biology, fundamentals of molecular biology, techniques in molecular biology, principles of genetic engineering, techniques in genetic engineering, techniques in plant tissue culture, biotechnology for crop improvement, biodiversity, IPR, biosafety and bioethics, plant metabolic engineering, MSc (Animal) Biotechnology Major courses: Molecular genetics and cell biology, techniques in cell biology, fundamentals of molecular biology, techniques in molecular biology, principles of genetic engineering, techniques in genetic engineering, techniques in animal tissue culture, biotechnology for animal improvement, biodiversity, IPR, biosafety and bioethics, Introduction to immunology and vaccinology. Minor courses viz. essentials in biochemistry, molecular biophysics, bioinformatics & statistics, microbiology are common to agriculture and animal biotechnology. MSc (Medical) Biotechnology: Biochemistry and cell biology, human physiology, quantitative methods, molecular biology, genetics and developmental biology, medical microbiology, genetic engineering, genomics and proteomics, human genetics and human genome, immunology, vaccines and transplantation technology, somatic and germline engineering, social, ethical and legal issues in medical biotechnology, diagnostics and communication skills as well as optional courses. In MTech courses, students from different background such as BTech biochemical engineering, chemical engineering and MSc Biotechnology are admitted. Students can opt for different courses in the first semester. Students with BTech biochemical engineering are offered courses in biochemistry, biophysics, enzyme catalyzed organic synthesis, analytical methods in biotechnology, carbohydrates and lipids in biotechnology, fluid solid systems, food science and engineering, thermodynamics of biological systems, multistage separations, biosensor technology, advanced bioprocess control. Students with BTech chemical engineering are offered biosensor technology, microbial biochemistry, lab techniques in microbial biochemistry, enzyme and microbial technology, recovery and purification of products, biochemical engineering fundamentals while MSc students are offered courses in bioprocess engineering enzyme and microbial technology, recovery and purification of products, biochemical engineering fundamentals, applied mathematics, process engineering principles. Courses on protein engineering, advance bioprocess engineering, animal and plant cell technology, bioinformatics methods and application, pharma biotechnology, combinatorial biotechnology, modeling and simulation of bioprocess, bioprocess plant design are offered in second and third semester along with major project in third and fourth semester. (Please visit the DBT website http://www.dbtindia.nic.in for curriculum details). Placement analysis The success of a teaching program is primarily judged by the quality of education imparted and placement of students passing out. These programs have flourished as students coming out of these programs qualify in UGC-CSIR National Entrance Test (NET) for Junior Research Fellowship (JRF), DBT Biotechnology eligibility test (BET) for JRF and are pursuing research in leading laboratories in the country like the TIFR, BARC, IISc, NII, CCMB and JNU. A number of students find placement in leading industries such as Biocon, Dr Reddy's Laboratories, Shantha Biotech, Panacea, Advanced Enzyme Technology, Bharat Serum, Intas Pharmaceuticals, Serum Institute, US Vitamins, Wockhardt and Zydus Cadila Pharmaceuticals. The analysis of the first placement of approximately 1000 students produced during 1985 -1995 shows 54 percent students opt for PhD within the country, almost ¼th students opt for jobs in research, teaching and industry. The analysis of 2000 students produced during the last five years depicts almost similar trend. However, percentage of students working in industry has increased from 12 to 17. As expected, MSc general, agricultural, medical, marine biotechnology students prefer PhD while MTech students (almost half) join industries. The Biotech Consortium India Ltd (BCIL) brings out a priced publication, "Directory of research institutions and industries in biotechnology in the country" with details of area of specialization and contact persons. Students willing to obtain a copy of the directory for details of industries may please contact: Dr Purnima Sharma, CEO and Executive Director, Biotech Consortium India Ltd, Anuvrat Bhavan, Deen Dayal Upadhyay Marg, New Delhi-110002 Industrial training Prominent industry leaders and HR experts feel that it is difficult to find the right candidates as the skillsets of manpower produced by academic institutions often do not match the requirements of the ever competitive biotechnology industry. This could be due to a big gap between the knowledge imparted vis a vis knowledge required by the industry. Finding the right people for the job is the immediate challenge faced by the industry, as the industry finds it difficult to invest in in-service training of hired candidates. To bridge this gap, the Department of Biotechnology is facilitating practical exposure to biotechnology postgraduates for a period of six months in the industry. This program is mutually beneficial to the students and industry. Industrial exposure orients students to the needs of the industry increasing their acceptability and also provides an opportunity to the companies to assess their performance. This program has completed 15 years and has become increasingly popular among students and industries as is evident from increase in number of applicants and number of selected candidates. The number of industries offering this training has also steadily grown. Several leading biotechnology companies like Monsanto, Workhardt, Aurigene Discovery Technologies, Gangagen Biotech, Lifecare Innovations, Dabur, Dr Reddy's Lab, Panacea Biotech, JK Agrigenetics, Auroprobe Labs, Nicholas Piramal, Jubilant Biosys, Pepsi Foods, Pepsico Holdings, ABL Biotech Ltd and Mahyco have offered training to the students. This industrial training has facilitated in permanent placement of students in the industry with a success rate of approximately 25 percent. Some of the industries who have absorbed trainees are Lifecare Innovations, Unique Biotech Ltd, Century Seeds, Sangene Biotech and Shantha Biotechnics, Dabur, Jubilant Biosys, Gangagen Biotechnologies and Monsanto. Career opportunities The biotechnology industry has recorded 37 percent growth and has touched the $1.5-billion mark with biopharma accounting for 72 percent share, bioagri sector being the fastest growing sector with 80 percent growth and bioservices growing at 69.3 percent and occupying 11 percent of the market share (industry overview, Biospectrum, July 2006). India is becoming one of the most important destinations for clinical trials of new drugs, field trials of genetically modified plants, contract research and contact manufacturing. On the venture capital front, the funding activity has shown significant momentum in India during 2005-06 by registering a growth of 150 percent over the last year (BioSpectrum, November 2006). Biotechnology has applications in all spheres of human and animal life such as food and nutritional sufficiency, health, crime investigation and forensic science, environmentally sustainable development. Predictions of IT-BT led boom in the coming years resulted in hype with hope for creation of a number of jobs in the coming years. This has led to mushrooming of a large number of private and public sector institutions conducting self financing degree courses in biotechnology both at undergraduate and postgraduate levels. This expansion has led to a general deterioration in quality of manpower which is a major concern with producers as well as employers of manpower. The need for accreditation of institutes offering teaching programs has never been felt so strongly before. Opportunities for biotechnology students exist in agri-based industries involved in production of transgenic plants, seed industries, tissue culture units, agri chemicals such as biofertilisers and biopesticides, environmental amelioration, pharma industries for diagnostics, vaccines, new drug molecules, clinical research organizations and bioinformatics industry. Opportunities exist in research and development, production and manufacturing, quality control and analysis, technology transfer and management knowledge-based marketing, setting up of new enterprises, consultancy organizations for preparation of techno economic feasibility reports, regulatory affairs such as toxicology, environment health and safety, biosafety, patent attorneys and examiners for IPR. The jobs for marketing are 20 times more in number as compared to R&D as well as more monetarily rewarding. With India becoming a signatory to GATT, a sudden spurt in filing of patents as well as dispute settlement cases has been witnessed resulting in the creation of tremendous opportunities for patent attorneys and examiners. In addition to the industry, opportunities for science management, teaching and R&D jobs exist in public and private sector teaching and R&D institutions. These teaching programs have improved teaching and research not only in biotechnology but also in allied life sciences areas such as botany, zoology, microbiology, biochemistry and genetics. This initiative has provided necessary skilled manpower resource vital for biotechnology manufacturing, production and services on a sustainable basis. According to Dr Kiran Mazumdar-Shaw, CMD, Biocon, biotechnology in India has the potential of generating revenues of about $5 billion and creating one million skilled jobs in the next five years through products and services. This is indeed good news for students and professionals in this area. Shubhlata Sharma, senior scientific officer, and Dr Suman Govil, advisor, DBT, Ministry of Science & Technology. Note: The views expressed in this article are those of the authors and not necessarily of the organization to which they belong. Note: The complete list of DBT programs will be made available online. ]]> <![CDATA[Top Public Institutes in India]]> https://biospectrumindia.com/news/95/2172/top-public-institutes-in-india.html https://biospectrumindia.com/news/95/2172/top-public-institutes-in-india.html Wed, 10 Jan 2007 10:36:00 +0530 Top Public Institutes in India Top Public Institutes in India Amongst all institutes and colleges, which are imparting education at the BTech, MTech M.Sc or PhD level in biotech, Rajiv Gandhi Center for Biotechnology (RGCB), Trivandrum, emerges as the best top-ranked institution in the country. It is followed by University of Hyderabad, Hyderabad in the second position, National Dairy Research Institute (NDRI), Karnal in the third position, Institute of Chemical Technology, Mumbai in the fourth and IIT, New Delhi in the fifth position. While University of Hyderabad, Institute of Chemical Technology, and IIT, New Delhi have been in the Top 5 ranks in the previous year's survey, RGCB and NDRI are new entrants. Rank 2 The School of Life Sciences at University of Hyderabad is a teaching and research institute with a multidisciplinary approach. Prof. P Reddanna, coordinator, School of Life Sciences, University of Hyderabad, said, "The teaching program at the School are designed in a such a manner to provide the basic chemical and physical aspects of life as well as to impart information about the new frontier areas of life sciences." The School offers courses in MSc Biotechnology; M Sc Animal Biotechnology; M Sc Plant Biotechnology; M Tech Medical Biotechnology and PG Diploma in Bioinformatics. "The total intake across various programs is around 60 students and with full time faculty strength of 29 and with 25 of them having over five years experience and are PhDs. The School spends about Rs 1.10 crore on infrastructure spend as defined by BioSpectrum," said Prof Reddanna. Rank 3 This year's third ranked institute is the National Dairy Research Institute (NDRI), Karnal. "NDRI is the country's premier research institute. Activities on animal biotechnology research at NDRI were initiated during the Mid Eighties under a UNDP 'Center of Excellence programme on Biotechnology'. Under this program, infrastructure facilities for research in Biotechnology were developed at different divisions of the Institute. A Masters education program in animal biotechnology was initiated at NDRI in 1987. During the same year, on recommendation of the National Task Force of the Department of Biotechnology (DBT), a National Project on Embryo Transfer Technology (ETT) was initiated at NDRI, which was also supported by ICAR/USAID bilateral co-operation in its initial stages. This formed the basis for the establishment of a state-of-the-art Embryo Biotechnology Centre at NDRI having specialized laboratories for conducting advanced research on various aspects of embryo biotechnologies. Very intensive research on conducting embryo biotechnology research at NDRI resulted into evolving and fine- tuning of several embryo related technologies aiming at multiplication of superior germplasm. Works have been carried out on cryopreservation protocol for oocytes and embryos, ovum pick-up technique in buffalo, designing in vitro fertility evaluation tests and immuno-nutralization of inhibin leading to fertility augmentation. The centre is involved in conducting research on areas of high-end embryo biotechniques like transgenesis, somatic cell cloning and embryonic stem cell production. The center is also included in the 'Buffalo Gene Mapping' initiative of DBT and niche area of research on buffalo production and reproduction genomics by ICAR. The department has 10 well-experienced faculty members, each of who has over five years of experience and we invest close to Rs 50 crore per year on the infrastructure. The ongoing research projects are being funded by ICAR and several other national and international funding agencies to a tune of Rs 4 crore," pointed Dr SL Goswami, joint director (research), NDRI, Karnal. Rank 4 Institute of Chemical Technology (ICT) Mumbai, the fourth ranked public institute, earlier known as Department of Foods & Drugs, offers MTech (Bioprocess Technology) as an interdisciplinary course. The total intake for this course, with DBT fellowship seats as well as industry sponsored seats, is 30. According to Prof. SS Lele, coordinator, bioprocess technology, ICT, "There are 19 fulltime faculty members and several distinguished persons from industry and other institutes visit it imparted training to its students. We started MSc (Biotechnology) and PhD (Sci) Biotechnology courses in 2006 with an intake of three and five students respectively. And our yearly investment is over Rs 1.1 crore on infrastructure and we have Rs 7 crore worth of government and industry sponsored projects in hand." The major research interests include carbohydrate chemistry and technology with focus on Indian traditional foods; fermentation technology with focus on enzymes, plant cell culture, nutraceuticals and GM foods and food microbiology related to quality, safety and application of new technology. Rank 5 IIT Delhi, the fifth ranked biotech institute, offers biochemical engineering & biotechnology (BEB) course through an integrated approach model of teaching and research and development of various bioprocesses. "The courses offered by the department are BTech and MTech in biochemical engineering and Biotechnology, MS (Research) in Biomedical Engineering and Biotechnology, and pre PhD courses. The BEB course has been running since 1989 and we have 17 fulltime faculty, 13 of whom have over five years of experience and all of them are PhDs. The Department also offers a summer training program in May/June every year to provide intensive practical training to post graduate students. IIT Delhi spends close to Rs 1 crore on infrastructure related to books, journals, lab equipment, and consumables every year and we have about Rs five crore worth of sponsored projects in hand," observed Dr AK Srivastava, professor and head, Department of Biochemical Engineering & Biotechnology, IIT Delhi. Rank 6 The School of Biotechnology at Guru Govind Singh Indraprastha University, established in 1999 at the Kashmere Gate Campus in Delhi, is the sixth ranked biotech institute. According to Prof. PC Sharma, dean, University School of Biotechnology, Guru Gobind Singh Indraprastha University, New Delhi, "The BTech program curriculum stresses on convergence in modern biology, engineering and technology, applied orientation, quantitative approach, practical training, awareness of the broader social, economic, environmental, ethical, legal and managerial issues in biotechnology. Its faculty strength is 12 and has quality laboratory infrastructure for teaching and research, individual projects and good library. The school spends about Rs 2 crore on this infrastructure and has Rs 8.55 crore of industry and government sponsored projects The school offers a 5½ year (11 semester) integrated BTech/MTech program in biotechnology through an All India entrance examination. The school has a strong research program and PhD is offered in various disciplines of biotechnology like agricultural, environmental, industrial, biomedical and pharmaceutical biotechnology. Rank 7 Jawaharlal Nehru University, Center for Biotechnology, Delhi is ranked number seven. But it undoubtedly runs one of the finest masters degree programs in biotechnology. The CBT was established in 1985 under joint sponsorship of the UGC and the Department of Biotechnology. And in the same year the Master of Science program in Biotechnology was started at the Center. According to Prof. Rakesh Bhatnagar, head of the center, "The Center has a very successful MSc biotech program, which selects the best of the students from the merit list prepared on the basis of an All India Entrance Test conducted by JNU. Most of the MSc students have gone to do research in different institutions in the country and abroad. The students have got selected in many of the top research universities across the world-Cambridge, Oxford and Stanford. About a third of JNU students go to the US, another one-third go to Europe and the rest get into the top Indian research institutes for their post doctorate degree. Very few students have taken up jobs in the industry." The spends close to Rs 3.8 crore on infrastructure every year and has also cash flows in the form of royalties worth Rs 25 lakh during 2005-06. Rank 8 MS University of Baroda's Department of Microbiology & Biotechnology Center, Vadodara, is the eighth ranked institute in this year's survey. In fact it is the top ranked institute on the placement score. About 10 companies participated in the campus recruitment and over 15 students were given job offers. According to Prof BB Chattoo, coordinator, biotechnology, the Department of Microbiology and Biotechnology Center at The Maharaja Sayajirao (MS) University of Baroda, "The department offers a two-year post graduate program leading to the Master of Science (MSc) in Biotechnology and we have a strong base in microbial technology and the main features of the program include genetics, molecular biology, industrial microbiology, biophysics, bioinformatics and immunology. The biotechnology center takes about 10 students and has research projects over Rs 3.8 crore at hand." Rank 9 Madras Veterinary College is one of the oldest institutes started in 1903. The Department of Animal Biotechnology, which was started at the Madras Veterinary College in 1989, is the ninth ranked institute. Dr P Ramadass, professor and head, Department of Animal Biotechnology, Madras Veterinary College, said, "The Indian Council of Agricultural Research (ICAR) recognized the center as a 'Centre of Excellence in Veterinary Biotechnology and Immunology' in 1999. This Department is the first Animal Biotechnology Department in India that has been awarded the ISO 2001:9000 for Quality Management Systems through the British Standards Institute, UK. It has been awarded a niche area scheme on 'Molecular diagnostics for emerging avian viral diseases and their immuno pathogenesis' with a budget overlay of Rs 2 crore for two years." Rank 10 University Institute of Engineering & Technology (UIET), Panjab University, Chandigarh is ranked tenth in this year's survey. According to Prof. BS Sohi, director, UIET, Panjab University, "The department is running the BE Biotechnology course since 2002 and we have a faculty strength of 12. The institute spends about Rs 50 lakh on infrastructure. Further about Rs 10 crore worth of equipment is available at central instrumentation facility at Panjab University for biotechnology students. The BT education in India has been in the public domain, though in the last few years the private institutes have invested money in higher education. Amity Institute of Biotechnology, Noida, Birla Institute of Technology, Jaypee Institute of Information Technology, Biotechnology, Noida, The Oxford College of Science, Bangalore, Seedling Aacademy of Design, Technology and Management, Jaipur, Shree Manibhai & Navalben Virani Science College, Rajkot, etc. are making significant inroads into imparting BT education. One big difference between the private and the public institutes is that the private players focused more on placing the students in the industry. As has been mentioned in the survey methodology earlier, four parameters have been used to arrive at the overall score or ranking-Faculty, Infrastructure, Industry interaction and Placements. Even within Top 10, ranking of institutes vary substantially on these four parameters throwing up gaps, which can be addressed by the respective institutions. To take some examples: RGCB occupies the top rank under Infrastructure, second rank under Faculty and fourth rank under and Industry Interaction but does not do well on Placement. On the last parameters, the University does not figure even in Top 20 institutes for the particular parameter. This is understandable considering the fact that it is a research institute. Perhaps, in the next few years one has to look at the number of incubations that the public institutions have as one of the ranking parameters. University of Hyderabad stands second an overall ranking and is top ranked on Faculty and Industry Interaction and eighth on infrastructure and tenth on placement. NDRI is ranked second on industry interaction, third on infrastructure, and fourth on faculty. Its placement ranking in not among the Top 20. The reason it is a research institute too. Institute of Chemical Technology, Mumbai figures in Top 10 on three parameters-Faculty, Industry Interaction, and Placements. Given its fifth overall ranking, IIT, New Delhi does well on Faculty, Infrastructure and Placement scores but it did not do well on Industry Interaction. One would observe that the rankings are contrary to public perception. The reason for this is that we have not ranked the institutes on the basis or courses but on the basis of institutes offering biotech education-be it BTech, MTech, MSc, PhD. It may also be pointed out that the data analysis has been done on the basis of the data provided to us by the institutes and we have not physically verified the same visiting the campuses. That is why one finds it different from the popular perception. Take for example the IIT Kharagpur. One of the students has informed us that it is missing from our surveys. "I think this is one of the best with its facilities and achievements by its undergrads. It is preferred over IIT D biotech. The facilities at IIT KGP's biotech department come in one to the best in India," said the undergraduate from IIT Kharagpur. However, we did not have the filled forms from IIT Mumbai and IIT Kharagpur, despite constant follow-ups. So our survey is based on the available written information and we have tried to be as objective and succinct as possible. ]]> <![CDATA[India]]> https://biospectrumindia.com/news/95/1065/india.html https://biospectrumindia.com/news/95/1065/india.html Wed, 10 Jan 2007 10:28:00 +0530 India India's Top BT Institutions Rajiv Gandhi Center for Biotechnology, Trivandrum, is India's leading biotech institution. Rajiv Gandhi Center for Biotechnology (RGCB), Trivandrum, emerging as India's top biotech institute in 2006 was a surprise to BioSpectrum too. The Center has turned out to be the dark horse. So far it has managed to thrive without much fanfare and publicity, in a relatively low-key atmosphere. Institutes like Jawaharlal Nehru University, Delhi; University of Hyderabad, Hyderabad; Institute of Chemical Technology, Mumbai; IIT, New Delhi; and Anna University, Chennai, are some of the well known institutes that enjoy top mind share in the biotech community . We all knew that the Rajiv Gandhi Center for Biotechnology was taking off in a big way focusing on research and development in a niche industrial area. The Centre was accorded the status of autonomous national institute. And the Finance Minister, P Chidambaram, presenting the 2005-06 Budget, proposed a Rs 521 crore outlay, an increase of Rs 76 crore over the previous year, to boost research in the biotech field. And the Rajiv Gandhi Center for Biotechnology was "upgraded" at the request of the Ministry of Science and Technology. (Until then, the institution was under the Kerala State Council for Science and Technology.) The Union Minister for Science and Technology and Ocean Development, Kapil Sibal, said the move was meant to allow the Center to undertake more research as well as train more young scientists. All these moves augured well for the Rajiv Gandhi Center for Biotechnology, which has 28 full-time scientists and doctoral students. Given the interest worldwide in employing biotechnology to improve human development, the Rajiv Gandhi Center for Biotechnology can be expected to do more. The facilities at the Rajiv Gandhi Centre would not only help the institution but also in projecting India as a potential destination for biotech research and business. In March, its proposal for a business incubator facility was cleared in principle by the State Biotechnology Commission. Prof. M Radkakrishna Pillai, Director of the Rajiv Gandhi Center for Biotechnology, told that the RGCB Incubator Facility (RIF) would function as a non-profit unit to help young scientists who have the technological and organisational capacity to design and develop biotech products and processes but lack the financial resources to start an enterprise. The RGCB has developed a drug based on a "one-time ayurvedic remedy" to fight the side effects of radiation. According to Prof. Pillai, the drug was the result of a collaborative research project involving a scientist, cancer physician and an ayurvedic medic using herbs, commonly available in the courtyards of homes in Kerala. This was the first time such a collaborative effort was being made. The final product of this effort should be available to those suffering from cancer for a mere 50 paise. A similar drug being sold in the US was priced at $200. "Delivering discovery for the nation is our mission," said Prof. Pillai. "There are many who share the idea that biotechnology will follow information technology to become a mainstream focal point in the generation of a knowledge-based economy. Indeed, progress in biotechnology will rely on information technology and computational biology allowing deeper understanding of the nature of biological processes. If translating biotechnology to economic and social gain is the critical requirement for India, then the country's investment in Rajiv Gandhi Centre for Biotechnology (RGCB) is wholly justified. The institute's moment of reckoning came in February 2006 when the Union Finance Minister in the National Budget announced the decision to accord RGCB the status of an autonomous national institute, thereby confirming its stature as a center of excellence in biotechnology." RGCB has adapted interdisciplinary mode of biotechnology research. The academic and research units at RGCB have clear objectives and goals. In medical biotechnology, RGCB scientists utilize information and techniques available in the post genome era to understand etiology, pathogenesis and disease course of acute and chronic diseases besides developing strategies for prevention and cure, including newer therapeutic molecules, vaccines and improved diagnostics. RGCB biotechnologists also work on the development of disease resistant pepper and ginger, two of the Kerala's important cash crops besides developing and characterizing medicinal plants and derivatives. The institute's PhD program is one of the most sought after in the country and a major provider of trained manpower to academia and industry. "I am confident that that RGCB will continue to lead the translation of biotechnology into nation building, providing leadership, scientific expertise and infrastructure for progress in biotechnology. My scientific, technical and administrative colleagues and I intend to apply our vision, passion, discipline and conscience to lead RGCB into a new horizon for biotechnology applications and development," concluded Prof Pillai. Methodology The BioSpectrum Top Biotech Schools 2006 study includes information pertaining to BTech, Masters and PhD courses but not of BSc. courses. This study, the third in our series, was conducted in November 2006. To maintain objectivity and avoid biases in ranking the institutes, BioSpectrum based its methodology on measurable and quantifiable data. As a result, the research team did not seek perceptions and opinions of stakeholders such as students or industry to rank the institutes. BioSpectrum team sent questionnaires to over 200 institutes and followed up with them. We received a total of 102 questionnaires. Step - I : Identification of Parameters for Ranking of the Institutes Like the previous year's studies, the parameters suitable for ranking of the institutes were identified in consultation with experts from the industry, education and R&D. Suitability of a parameter was decided after telephonic discussion with 15 experts. From the discussion it had emerged that Faculty, Industry Interface, Infrastructure and Placements were the most important parameters on which the institutes should be ranked. These parameters have been used for ranking of the institutes this year as well. Step - II : Importance Ranking of the Parameters Structured questionnaire was used to take opinion of 15 experts on relative importance of the four parameters prior to the study. Their opinion was taken in to consideration for deciding on weights to be assigned to each parameter. The following means emerged based on data received from experts: Faculty and infrastructure had emerged as the two most important parameters ahead of placement and industry interaction. These two parameters get nearly two third importance in the overall ranking. In the present study also these weights have been applied to parameter scores of an institute to arrive at the final score. Step - III : Data collection, Analysis and Ranking of the Institutes A pre-tested structured questionnaire was sent to Directors/ Principals of Biotech institutes by the BioSpectrum team. BioSpectrum received responses from 102 institutes, colleges or departments. BioSpectrum scrutinized and validated the responses given by these institutes for accuracy, consistency and sufficiency of the data, data entry, analysis of the data and ranking of the institutes. The research team spent considerable amount of time accurately analyzing the filled in data for each institute: For each institute, a score was arrived at for each parameter. For a particular parameter, the score was a composition of each of the sub-parameters. For example, Faculty score of an institute would be composed of faculty per student, qualification of faculty members, qualification of faculty members, research article contribution of the faculty to national and international journals, patents filed and granted. Infrastructure score would be similarly composed of capital expenditure on lab equipment and consumables, expenditure on books and journals, and availability of dedicated and shared PCs per student. Similar scores were arrived at for industry interaction and placement using sub-parameters. Appropriate and largely consistent weights were used for sub-parameters wherever necessary. To give an example, faculty members with PhDs and above were given a higher weight than non-PhDs to arrive at the qualification score. Similarly, publications in international journals were given a higher weight than publications in national journals. More recent publishing of papers, or more recent patents filed/ granted have been given higher weights during analysis. Sub-parameter scores were indexed with hundred points being granted to the institute with highest score for a particular sub-parameter. Indexed scores were than added up for each institute to arrive at the Total Score for a particular parameter. Scores were than averaged on hundred. Each of the parameters (faculty, infrastructure, industry interaction and placements) was further weighed as per weights provided by experts to arrive at the total score of an institute. The institutes were than ranked as per this score on an overall basis. The Ranking was done separately for the Public and Private Institutes. ]]> <![CDATA[BioClusters News]]> https://biospectrumindia.com/news/95/1209/bioclusters-news.html https://biospectrumindia.com/news/95/1209/bioclusters-news.html Thu, 14 Dec 2006 11:27:00 +0530 EU industry hails Parliament hearing on Green Biotech EU industry hails Parliament hearing on Green Biotech On the 10th anniversary of safe and sustainable farming with green biotechnology, EuropaBio, the European Association for Bioindustries, with 60 direct members operating worldwide and 25 national biotechnology associations representing some 1,500 small and medium sized enterprises has hailed the European Parliament's public hearing: Biotechnology: Prospects and Challenges for Agriculture in Europe. EuropaBio strongly supports fora such as the Parliamentary hearing that look to examine the arguments for and against GM farming in a methodical, sensible fashion, using science-based research to drive the discussion. GM crops approved following rigorous safety assessments have been grown around the world commercially for 10 years. They have been consumed for over 10 years with not one single recorded negative health incident. Currently, biotech crops are grown in five EU countries (Czech Rep, France, Germany, Portugal and Spain). The evidence is that European countries and public opinion are increasingly less negative and more open to biotech crops. Yet small minorities of member states are trying to block the growth in acceptance of biotech crops in Europe and deny European consumers and farmers the choice to use labeled, safe products. In an increasingly globalized and competitive world, EuropaBio believes it is important to encourage companies to bring innovative products to market for the benefit of both farmers and consumers. The future competitiveness of Europe's agricultural and food processing industries will depend on plant genomics, biotechnology and their smart application. Europe's position in this arena is declining as a consequence of the political inertia caused by the polarized and increasingly heated debate between opponents and advocates. Source: www.europabio.org   Malaysia's Biotech Council approves Biosafety Act Malaysia's National Biosafety-Biotechnology Council approved the Biosafety Act in a meeting chaired by the prime minister, Dato Seri Abdullah Ahmad Badawi, and attended by cabinet members who discussed the implications of the Act on the country's biotechnology industry. The Biosafety Act is expected to complete the National Biotechnology Policy, which aims to regulate the use of genetically modified organisms (GMOs). It is expected to be discussed in Parliament this November. In related developments, the proposal to set up a National Biosafety Board will also be tackled in Parliament next year. The Board will be responsible for approving the import and export of biological products. In addition, a Genetic Modification Advisory Committee comprising scientists will be formed to assist the Board in implementing policies. Source: www.bic.org.my   Industry calls for patient-centered healthcare system EuropaBio has strongly supported the far-reaching initiative taken by the EU Commission and the member states to address the competitiveness of the European-based bio-pharmaceutical industry that will benefit patients and society. Dr Andrea Rappagliosi, chairman of EuropaBio Healthcare Council, urged, "Timely access to innovative medicines should be granted within a framework of investment needed for adequate coverage. Not only is the future of more than 2000 young European small and medium life science companies at risk, but also the future development of their research projects that specifically address healthcare benefit to patients." EuropaBio calls for the creation of similar platforms in member states. This will support the debate fostered by the pharmaceutical forum that will develop specific proposals to ensure that patients across Europe benefit equally from European biotech innovation. The healthcare biotech industry not only contributes to the progress in medicine, but also to advancements in the knowledge and science underlying life-threatening diseases and their causes. Source: www.europabio.org   New Zealand's Ministry of Health issues guidelines on use of stem cells Guidelines on the use of cells from established human embryonic stem cell lines for research have been published by New Zealand's Ministry of Health. In November last year the ministry released a discussion document on the guidelines for public consultation. The deadline for written submissions closed on March 3, 2006 and the proposed guidelines were reviewed in light of submissions received. The guidelines will allow New Zealand researchers to use cells from established hESC lines in research with a number of restrictions, including mandatory ethical review of hESC research applications. The ministry noted that the guidelines will be reviewed following the outcome of the Advisory Committee on Assisted Reproductive Technology's consideration and public consultation on the research use of human embryos in New Zealand, including their use to derive stem cell lines, in the second half of 2006. Source: www.nzbio.org.nz   DTI indicates £7.5 million funding for bioscience, healthcare activities The Department of Trade and Industry (DTI), Government of United Kingdom, has indicated £7.5 million funding and the Biotechnology and Biological Sciences Research Council (BBSRC) £1 million funding, through the Collaborative R&D program for bioscience and healthcare, for technologies for development and manufacture of biopharmaceuticals. Development and manufacturing of biopharmaceuticals poses particular technical challenges and the expansion of the global market for biopharmaceuticals is creating a significant opportunity for the UK's expertise in bioprocessing. According to a release, proposals are sought for collaborative R&D projects which will develop novel technologies that would reduce the time to clinic or market of new biopharmaceuticals and/or lead to more cost efficient processes for the development and manufacture of protein therapeutics, monoclonal antibodies, vaccines and gene therapies. These may be: industry-oriented basic research; or applied R&D projects; or experimental development (technology validation) projects; and involve science-to-business (S2B) or business-to business (B2B) interactions. Commenting on the funding, Tony Bradshaw, director, bioProcessUK, managed as a stand-alone business unit of the BioIndustry Association (BIA) said, "This injection of funding will help to ensure that bioscience research discoveries become the innovative technologies to develop the biopharmaceutical medicines of the future. The Collaborative R&D funding complements the recent funding of academic research by the Bioprocessing Research Industry Club. The funding is an indication of the significant commitment to the importance of bioprocessing as part of the drug development process." Source: www.bioindustry.org   Over 20,000 people work in biotech industry in Germany In total, 480 enterprises in Germany are substantially or exclusively active in biotechnology, in accordance with the Organization for Economic Co-operation and Development (OECD) definition (dedicated biotech firms). For a further 59 companies, modern biotechnology is a field of activity or business existing alongside others (innovative biotech firms). Included in this group are, above all, pharma and chemical companies and/or seeds manufacturers. Fourteen of the 480 dedicated biotech firms, or 2.7 percent, were listed on the stock market in 2005, according to a survey conducted by biotechnologie.de. The biotechnologie.de is a portal commissioned by the Federal Ministry of Education and Research (BMBF) to carry out a biotechnology company survey within Germany, based on the OECD guidelines, making this the first reliable description of the German biotech industry that allows valid comparisons to be made with other countries. The survey shows that approximately 24,000 people are employed in the sector of commercial biotechnology. Of these, approximately 13,000 are working within the 480 dedicated biotech enterprises. Less than half of these employees (45 percent) have university-level qualifications. According to the survey the number of employees in individual companies shows that small companies make up the majority of the German biotech industry. A good 88 percent of the companies employ less than 50. Scarcely 48 percent have between 10 and 49 employees, with 40 percent having only 1 to 9 employees. Only 7 percent of all enterprises employ between 50 and 99. Just 4.5 percent of the 480 dedicated biotech enterprises have more than 100 employees and only one percent employ more than 249. Source: www.biotechnologie.de   Biofuel production may become an issue in 2006 election: BIO Survey Four in five US adults (80 percent) strongly or somewhat agree that national and state governments are not doing enough to promote production of biofuels-fuels made from agricultural crops or plant matter, according to a new survey released by the Biotechnology Industry Organization (BIO). The survey, conducted by Harris Interactive, also found that 82 percent of adults say national and state governments should provide financial incentives to biofuels producers to encourage the production and availability of biofuels. More than two out of three adults (69%) would use American-made biofuels even if these fuels cost slightly more than conventional gas. And more than eight of every 10 (84 percent) say they would be at least somewhat likely to support federal and state political candidates who favor providing incentives to promote increased production and availability of biofuels throughout the US. Jim Greenwood, president and CEO of BIO, said, "Developing domestic biofuels and ending our over-reliance on foreign oil appear to be top concerns among Americans in this election year, our survey finds. Reducing dependence on oil and lessening environmental impacts are important to our nation's future economic growth and competitiveness. A strong majority of Americans clearly support federal and state financial incentives to promote development of biofuels such as ethanol that can help end our addiction to oil. And they are ready to support political candidates who favor such incentives." He further said, "We see support for continuing and expanding existing tax credits and other biofuels production incentives. Next year, Congress will have the opportunity to fund advanced research and provide additional incentives that will help build a growing biofuel industry that will continue to enhance our national security and create new jobs going forward." Source: www.bio.org ]]> <![CDATA[The advancing science of chromatography column packing]]> https://biospectrumindia.com/news/95/2447/the-advancing-science-of-chromatography-column-packing.html https://biospectrumindia.com/news/95/2447/the-advancing-science-of-chromatography-column-packing.html Thu, 14 Dec 2006 11:20:00 +0530 Chromatography Advisor Chromatography Advisor # 2 The advancing science of chromatography column packing Chromatography is the most powerful purification method available to drug manufacturers for the downstream processing of biotherapeutics. The number of drugs in development and commercial production has grown rapidly, especially antibody-based drugs requiring large doses and long treatment periods. For chromatography operations, this has placed unprecedented demands on speeding processing and increasing throughput-all while keeping costs down. A critical aspect of chromatography is column packing, and advancing technologies have helped improve this important step for drug processing. This second in a series of chromatography "advisors" offers a brief examination of some of the innovations in packing methods that the marketplace has experienced, and a peak of some new trends on the horizon. The goal for any chromatographic operation is to ensure the most optimal flow distribution possible within a column. At the same time, for all quality controllers one key question is always top-of-mind: "Is my process reproducible?" A well-packed column bed should have a homogenous density throughout its surface area, and the space between particles-known as "interstitial volume"- should be controlled. As the liquid mobile phase enters the column the flow profile should ideally form a "plug-flow" pattern with minimal "band broadening"; broad bands during separation reflect poor resolution and performance, and it impacts on the purity of the target products being eluted. The resin media used varies depending on the operation, and some can be quite costly. Possible failures can include density inconsistencies or local voids in the bed, which can lead to flow aberrations and irregularities and even to bed instability. In the worst case scenarios beds can crack or form a moving void as feed is being processed, ruining batches in process. A skilled craft It is hard to conceive that just a few years ago packing chromatography columns was largely a manual process that required extensive skills and training akin to a practiced art. Traditional column packing employed a "dry packing" or "tap packing" method. Chromatography resins were supplied dry, columns were agitated to help particles settle, and the media would then be hydrated directly in the column. Eventually resins were supplied pre-hydrated, and "flow packing" became the new and improved procedure. Operators would pour media as a diluted slurry directly into columns from a container or conditioning tank, and the suspended media would then be stirred to ensure as much homogeneity as possible. The column's top end cell would be inserted and sealed, and liquid flow pressure applied to settle the resin particles. The end cell needed to be manipulated to remove any trapped air above the column bed, and the bed surface needed to remain undisturbed. Given the number of manual manipulations required, reproducing flow packing procedures in a cGMP environment was typically beyond the skills of even moderately experienced operators. Increasing automation In the mid-1990s an automated packing method called "pack-in-place" entered the market and has since changed the manufacturing paradigm for chromatography. Pack-in-place has transformed production-scale column packing from a skilled craft into a hard science, largely eliminating the "human factor" in production. Today, approximately 70 percent of all new process chromatography operations employ some type of pack-in-place automation, and new innovations have made monitoring and control of packing more accurate and reliable. This has improved packing reproducibility and process control, and has ensured more consistent packed bed performance. Pack-in-place procedures are selectively calibrated to reflect different chromatographic media and adjust for the ideal rate at which packing should be performed. In this way it yields the optimal media compression within a homogenous bed to maximize column performance. By eliminating operator handling, column packing automation removes the human variables so common with manual packing methods, and this has vastly reduced the chances of column failure. It has also improved manufacturing productivity significantly since column packing and unpacking can both take place with columns fully assembled. Fully contained system eliminates contamination Perhaps the greatest benefit of pack-in-place is the fact that packing operations take place in fully contained systems. Adjustable or fixed end cells are in place at ultimate bed heights, and operators form beds by pumping in slurry and simultaneously exhausting excess liquid. Since all procedures, including clean-in-place operations, take place without removing the top column assembly, this minimizes the risk of operator contact with potentially hazardous materials (for example in vaccine production), and it reduces exposure of drug products to external contamination. Overall, the procedure is more hygienic. A key feature of automated packing is a separate slurry packing system or station (SPS), which delivers media slurries to columns during packing and unpacking. An SPS system mixes and then pumps media into columns at a controlled rate and pressure. An adjustable end cell can be set at a desired packed bed height, and media is pumped into the column to form a bed, while excess buffer is exhausted simultaneously. Packing procedure Packing procedures vary depending on the type media used in an operation. There are three general categories of media used for processing biotherapies: carbohydrate-based matrices such as agarose, dextran, or cellulose; polymeric media, usually methacrylic or styrenic matrices; and rigid packings such as silica or controlled pore glass. Packing procedures are generally divided up into four categories to accommodate the most commonly used media: Variable and pressure packing, which is used for moderately compressible media. The column pressure and bed height are allowed to increase slowly, and packing is complete when hydraulic pressure within the bed drops noticeably. Constant pressure packing, which uses more rigid media, requires that packing pressure be continuously kept at three bar throughout the packing process until the bed meets the bed support. Flow-compression packing, during which the piston is set at a higher bed height as slurry is pumped in. The slurry is then flowed at three bar for 15 to 30 minutes, and the piston is then moved onto the top of the bed. Fixed media volume packing, which is useful for costly media such as Protein A, requires bed volumes to be completely settled before slurry can be pumped into columns. Exiting mobile phase can be recycled to wash the slurry tank back into the column. Looking ahead Column chromatography operations have clearly benefited from the advent of pack-in-place automation, and it has helped manufacturers meet cGMP requirements as throughput demands continue to increase. Looking ahead, a new technology is emerging to help monitor and control chromatography packing in real-time: ultrasound sensors. This new innovation, currently in beta-testing, holds great promise for optimizing packing and increasing operator control. Ian Sellick, Marketing Director, Pall Corporation/BioPharmaceuticals   ]]> <![CDATA[Growth of Indian biopharma provides opportunities for PAS]]> https://biospectrumindia.com/news/95/1590/growth-of-indian-biopharma-provides-opportunities-for-pas.html https://biospectrumindia.com/news/95/1590/growth-of-indian-biopharma-provides-opportunities-for-pas.html Thu, 14 Dec 2006 11:16:00 +0530 Growth of Indian biopharma provides opportunities for PAS Growth of Indian biopharma provides opportunities for PAS Honeywell Automation has been helping process industries like oil and gas, petrochemicals, life sciences and biopharmaceuticals, make their processes more efficient, more productive, profitable and safer. Recently, Honeywell came up with its latest Process Knowledge System (PKS), Experion R300 a unified system for process, business and asset management that helps industrial manufacturers to increase their profitability and productivity. In an e-mail interview, Harshavardhan Chitale, managing director, Honeywell Automation India, shared his thoughts with BioSpectrum about the benefits the automation systems can offer to the life sciences/biopharma companies. How will the automation systems benefit biopharmaceutical/life sciences companies? The life sciences and biopharmaceutical industry constantly face following challenges: repeating successes at research/pilot stages into commercial stages, time to market, maintaining consistency in product quality, achieving and ensuring regulatory compliances, security and protection of intellectual property, integrating the supply as well as value-chain, and staying competitive Traditionally, these were "managed" without much of automation and/or integration amongst various functional requirements including manufacturing processes but this was not an efficient way of succeeding in competitive world. Process Automation Systems provide the answer to meet these challenges. Honeywell's Automation System, Experion Process Knowledge System provides solutions that manages these challenges in the most efficient and integrated manner, that helps customers to reduce risks, to improve operational efficiency, helps in meeting regulatory compliances, besides reducing cost of such regulatory compliance, and to help manage lifecycle cost and to protect capital as well as intellectual investments. What is the kind of investment these companies have to make on automation systems? Investing into automation systems definitely is beneficial for any manufacturing industry including life sciences/biopharma. However, depending on the project size and scale, the levels of automation vary. There really is no ball-park figure regarding investments in automation systems as it is 'need' dependent rather than 'want' dependent. How do you see the market potential in terms of growth rate and present market size for process automation systems as far as the Indian biopharmaceutical/life sciences industry is concerned? India's pharma industry is currently undergoing a change from being process-patent centric to product patent centric. This change is leading the return of multinational organizations to India for setting up manufacturing facilities, due to India's traditional strength in low-cost contract manufacturing, attractive location for R&D and conduct of clinical trials. In addition, India's new affluent consumers who lead more western lifestyles, are demanding innovative drugs to treat chronic illness that these changing lifestyle may produce. Last but definitely not the least, India pharmaceutical companies are attaining global player status, since the existing market is expanding plus new ones are opening up, for high quality affordable generic drugs. The above factors indicate that the Indian life sciences/biopharmaceutical industry will maintain double-digit growth over next few years. This provides increased and sustained opportunities for process automation systems and associated services over next few years. The current market for process control solutions in India is growing rapidly at the rate of close to 20 percent y-o-y. Besides sheer growth, there is also a qualitative shift in terms of market characteristics. I would summarize them as: companies are no longer looking at automation as something, which is an 'infrastructure', but it is increasingly being viewed as an enabler of productivity, quality, safety, etc.; Increasing amount of advanced applications such as MES solutions; Tracking and supply chain solutions are being purchased by pharma companies as, experience of last few years has established the high ROI potential of such solutions; Process control solutions are no longer a luxury that only large chemical plants would implement. Even smaller enterprises in industries such as textiles, sugar, dairy, specialty chemicals have started reaping benefits of automation; Companies have started realizing that true value comes not from 'hardware' but from applications and engineering and the propensity of Indian customer's to pay for the same. Narayan Kulkarni   ]]> <![CDATA[Solar vaccine fridge developed]]> https://biospectrumindia.com/news/95/2938/solar-vaccine-fridge-developed.html https://biospectrumindia.com/news/95/2938/solar-vaccine-fridge-developed.html Thu, 14 Dec 2006 11:14:00 +0530 Solar vaccine fridge developed Solar vaccine fridge developed Dr APJ Abdul Kalam taking a look at SolarChill. India's President APJ Kalam has become the first customer for SolarChill, a new solar- powered, ozone-friendly vaccine refrigerator. Scientists have developed a vaccine refrigerator powered by solar energy. Called the SolarChill, the vaccine cooler will play a crucial role in delivering effective vaccines and refrigeration to remote areas in developing countries without electricity or with irregular electrical supply. Conceived and developed by an Indian scientist, Rajendra Shende, head of the UNEP's OzonAction unit, SolarChill boasts of an innovative and ozone-friendly technology. Realizing its merits and encouraging the adoption of this technology, the President, Dr APJ Abdul Kalam has bought the first two units of the SolarChill vaccine refrigerator. The units have been installed in the President's estate clinic. Elaborating on the breakthrough technology used, Shende said, "SolarChill combines environmentally sound refrigeration with solar energy. Its unique feature is that the energy of the sun is stored in ice instead of in batteries. The key to the technology is the use of a Direct Current (DC) compressor instead of the standard Alternating Current (AC) compressor used in normal refrigerators, or in other solar coolers. In addition, SolarChill incorporates environmentally friendly hydrocarbon refrigerants instead of the CFCs (Chloro fluorocarbons) and HFCs (Hydrofluorocarbons)." Significantly, the SolarChill technology is publicly owned. "Currently the SolarChill prototypes are being field tested in Senegal, Indonesia and Cuba. The WHO officials are happy with the incoming results. Once the field tests are completed and the technology is proven to be reliable and certified by the WHO, it will be freely available to entrepreneurs globally," Shende informed. Rolly Dureha   ]]> <![CDATA[Indian CROs chant consolidation mantra]]> https://biospectrumindia.com/news/95/2646/indian-cros-chant-consolidation-mantra.html https://biospectrumindia.com/news/95/2646/indian-cros-chant-consolidation-mantra.html Thu, 14 Dec 2006 11:12:00 +0530 Indian CROs chant consolidation mantra Indian CROs chant consolidation mantra Indian CROs are now moving towards consolidation to expand the existing operations, to enter newer areas and also become global players by opting different roots like tie- ups, acquisitions and partnerships India's entry into the patent regime in 2005 has brought in many MNCs, both the pharmas and CROs, to set up their offices or branches in India for their outsourcing activities. At the same time, mergers and acquisitions activity too has picked up pace in the Indian clinical research space, owing to lower costs and better infrastructure. Considering the India advantage factor and huge potential to do business from India, Amgen, the No.1 biotech company in the world, will be setting up its own CRO unit in the country to do its global studies. It is expected that Amgen will start its operations in January 2007. Other global CROs like PRA International and Parexel too have entered the Indian CRO space by using different approaches. In the recent past, the Indian CRO sector has witnessed many merger and acquisition deals. The latest one is the acquisition of Pune-based Sterling Synergy Systems by PRA International, a leading international CRO. On the other side, the US-based Parexel International has entered into an agreement with Synchron Research Services. The two have formed a joint venture called Parexel International Synchron, into which Synchron has transferred its clinical trial business. As a part of the same deal, Parexel has also acquired a minority stake in the clinical pharmacology business of Synchron Research in Ahmedabad. It is just not the MNCs looking at India. Indian companies too are looking at CROs outside the country to become global players. Last year, there was one such deal from Jubilant Organosys that has picked up 100 per cent stake in a US-based clinical research organisation (CRO), Target Research Associates, in a $33.5-million (Rs 145 crore) cash deal. This is the first acquisition of a US CRO by an Indian company, making it the largest Indian CRO with operations in India and the US. It will enable Jubilant to expand its CRO services globally. Moving towards consolidation Outsourcing will increase due to increased workload and larger studies without the internal staff to oversee the projects. As long as the trials keep getting larger and more complicated and R&D spend keeps going up, then outsourcing should climb steadily higher, according to a CRO industry update by William Blair & Company, USA. The outsourcing brings in a lot of opportunity for the Indian players. "India's entry into the patent regime in 2005 brought in more activities in the CRO space. It has increased faith and confidence among the sponsors and also among the global CROs who are now setting up base in the country," observed Dr Kiran Marthak, director, Veeda Clinical Research. India offers $1 billion opportunity in clinical research, according to reports. "It's going to be a big cake. Every one can have his/her share or pie in the big cake. Hence, firms are rooting for different options like acquiring stakes, having direct presence, mergers and acquisition to have their pie in the cake," said Dr Kiran Marthak. Recent trends Amgen to set up its own CRO unit in India PRA International acquires Sterling Synergy Systems, Pune Parexel International signs JV with Synchron Research Services, Ahmedabad Jubilant Organosys picks up 100 percent stake in Target Research Associates Barings Private Equity Partners buys stake in Siro ClinPharm ICICI Venture Fund picks up equity in Metropolis (Rs 35 crore). IL&FS Investment Managers invests Rs 45 crore in Manipal Acunova   Sharing his views, Dr Arun Bhatt, president, ClinInvent Research, said, "Mergers and acquisitions in the CRO space would keep happening in India. This is mainly because of three main factors-manpower, speedy trials to reduce time in conducting clinical research and also the quality of service. This would be beneficial to Indian CROs as it helps to enter new areas of operations, improve the image and offer quality services to the customers." "Inorganic growth is important for any business and a CRO is not an exception to it," noted Dr Rajesh Jain, senior manager, projects, Reliance Clinical Research Services. On consolidation of CROs, Dr Adeep Bagati, vice president, clinical research, Reliance Clinical Research Services, said, "It's a healthy sign. Consolidation of CROs will work better for sponsors as well as for Indian companies. In the next couple of years, we see more activities in alliances/ mergers or acquisitions. Consolidation helps the CROs that are into different areas of operations. It will work wonders for the companies that are into BA/BE studies by joining hands with companies which are into Phase I â€“IV clinical trials." "There are many areas that still need to be tapped like site identification, management, monitoring, training the manpower, issues related to ethic committees and identification of investigators. Opportunity exists for every one if they look at niche areas and also for consolidation to grow and to provide value added services to the customers," said Dr Anupama Ramkumar, director, Arkus Clinical Trail Support Solutions. The India advantage has pulled down the top global CROs like PPD, Quintiles, ICON, PRA, Parexel, Kendle, PharmaNet, Omnicare, Chiltern, and Covance to have a direct or indirect presence in the country. True to this, India witnessed the entry of many of these global CROs in the last couple of years. Commenting on the entry of global CROs, Priya Pawar, head, business development, SIRO ClinPharm, said, "They are under pressure from the sponsors to speed up the trial processes. They have no other way but to look at India as a destination for clinical research outsourcing activities. It will be beneficial for the Indian companies too to gain from their experience they had in doing trials globally." Dr Viral Shah, medical director, Global Spectrum Clinical Research, said, "The Indian CRO market has a very huge potential. Every one has an opportunity to set up his/her enterprise. The entry of global CROs like PRA International, Kendle, Parexel and Pliva will not affect the business for Indian CROs." Adding to this, Dr Chetan Tamhankar, chief operating officer, SIRO ClinPharm, said, "The Indian clinical research scene compares favorably with the best worldwide in terms of patient pool, cost efficiency, regulatory conditions, infrastructure and environment and relevant expertise. High quality, low cost, faster time, better local expertise, and additional expertise are actually favoring the contract clinical research activities in India." He further said, "The entry of MNCs shows that the Indian CRO sector is at a maturing stage. To be effective in the world market, the global CROs need to have strong foothold in India for their clinical research activities instead of having a loose arrangement. Just having an office in India with a handful of people will not work well as a good CRO should have at least have 40-50 skilled and trained personnel. The consolidation will continue for a while." Dr Kiran Marthak said, "Consolidation will increase the market size of Indian CRO segment. The entry of leading names in pharma and CROs in clinical research allows other small players to follow the giants. It is a good sign. Though the entry of global players in the CRO space will result in attrition of about 7-8 percent, it will bring in expertise and also skill sets to India. It also provides on-the-job training opportunity for local professionals. It will be a winâ€“win for both the Indian as well as global players." In addition to the CROs, global pharmas like Astra Zeneca, Eli Lilly, Johnson & Johnson, Pfizer, Sanofi Aventis, Novartis, Bayer, Merck and Wyeth, Novo Nordisk, Bristal Myers Squibb and Roche too have set up CRO units in India. These companies have been carrying out clinical trials as a part of global studies for data generation as well as for registration in the local market. "Faced with increasing R&D costs and diminishing pipeline output, these pharma companies are adopting a variety of strategies in an attempt to improve R&D productivity. Key strategies that are attracting industry attention at present include: M&A; Investing in R&D enabling technologies, such as high throughput screening, proteomics, combinatorial chemistry and genomics; eR&D, including eRecruitment, electronic data capture (eDC) and management, eNDA submissions and in silico research; adjusting corporate R&D structure and internal incentive mechanisms; outsourcing," noted Dr Kiran Marthak. Looking beyond India Indian CROs like SIRO ClinPharm, iGATE Clinical Research International, Lambda Therapeutics Research, ClinInvent are expanding their operations, increasing the headcounts and also making investments on infrastructure to make it more attractive for the sponsors. To fulfil such many other things, they do need funding. The venture capitalists, institutional bankers and the private equity partners are eager to fund these growing CROs, considering the low risks and high growth potential. There are few such investments from the VC community that have happened recently. Barings Private Equity Partners has bought a stake in Siro ClinPharm for an undisclosed sum. The stake is estimated to be less than 30 percent. ICICI Venture Fund has picked up minority equity in diagnostics-chain Metropolis Health Services for Rs 35 crore. IL&FS Investment Managers has invested Rs 45 crore by picking up a minority stake in Manipal Acunova. Commenting on this trend, Dr Kiran Marthak said, "In the next 2-3 years, Indian CROs might go for public issue for expansions and becoming global players. The Indian CROs are getting funds from venture capitalists/private equity." The Indian CRO segment has been growing in the terms of number of companies. The segment will get a boost because of more outsourcing activities. India witnessed not only the new entrants from the local players but also the global pharmas and CRO giants. The India advantage factor will push for consolidation of companies to offer better services and to leverage each other's expertise on their core strengths and to deliver within the timelines, a key parameter for a good CRO. Sponsors prefer CRO fragmentation Despite widespread views that the large drug companies are very cost conscious, cost was not among the top three attributes for defining a quality CRO. The key attributes are delivery within timelines, quality deliverables, flexibility, expertise and experience and then comes the cost. The other key factors include problem solving, responsiveness, customer service, and cooperation, efficiency, geography, consistency, intelligence, lack of staff turnover, minimal change orders, pro activeness. The CRO business is really about project management. A company that completes a study on time with clean data will usually have a happy client. This is according to the CRO industry update from William Blair & Company, USA that conducted a survey of pharma and biotech sponsors regarding their experience with the vendors in conjunction with Thomson CenterWatch. The global companies require global capabilities and prefer working with a single vendor rather than several, as it is favorable, easier access to patients, less expensive and better turnaround time. Many studies are international and moving outside the US, need to work where local affiliates are located, need to be present globally but act locally and companies without global expertise rely on the CROs for their global knowledge. Global CROs have an edge over the smaller, more narrowly focused peers as the trend of drug development is shifting beyond the US to better access patients and thus reduce time and cost. The CRO industry growth will come from the developing world. However, the CRO industry update reported that the consolidation of CROs would be bad for sponsors mainly because of factors such as costs would be less competitive, availability of CRO teams could diminish, too much control in too few entities, sponsors like going to different CROs for different services, CROs would lose focus and attention to detail, smaller and mid-tier CROs play a large role in the market and their service and quality would suffer if merged with large CROs. On the other hand, a few sponsors noted that consolidation would be good for them as CROs would spend less time and money on business development and the RFP process would be more standardized and consistent. The industry would focus more on quality and less on marketing and false promises. The CRO industry update by William Blair & Company, USA concluded that sponsors prefer CRO fragmentation and will probably not move quickly to a prime vendor model where one CRO gets virtually all the business. Sponsors also prefer the checks and balances of many CROs to the efficiencies that could be gained by more streamlined RFP/ bid defense process with fewer vendors. Narayan Kulkarni   ]]> <![CDATA[Plasma proteins matter a lot for India]]> https://biospectrumindia.com/news/95/8361/plasma-proteins-matter-a-lot-for-india.html https://biospectrumindia.com/news/95/8361/plasma-proteins-matter-a-lot-for-india.html Thu, 14 Dec 2006 10:39:00 +0530 Plasma proteins matter a lot for India Plasma proteins matter a lot for India AlbuRel is a Plasma Volume Expander (PVE) used to increase the circulating plasma volume in blood. Albumin is the most abundant protein in human plasma and is synthesized by the liver. Dialysis, burns, cerebral oedema, cirrhosis of the liver are some the many indications where Albumin preparations can be used. It is available in 20%, 5% concentrations in 100 ml and 50 ml pack sizes.   ImmunoRel is a solvent/detergent treated, sterile preparation of chromatographically purified immunoglobulin G (lgG) derived from pooled human plasma. The US Food and Drug Administration (USFDA) has approved IVIG for the use of primary immunodeficiences, Kawasaki disease, immunemediated thrombocytopenia, chronic B-cell lymphocytic leukemia, pediatric HIV Type 1 infection and haematopoietic stem cell transplantation in patients older than 20 years of age (Gamimune-N only). The normal immunoglobulin is meant for intravenous use. ImmunoRel is available in 5% concentrations in 100 ml and 50 ml pack sizes.   ReliSeal is a biological glue and hemostatic agent, which can be used in a variety of surgical procedures to arrest bleeding, seal tissues and as an adjunct to wound healing. A quick acting surgical fibrin sealant derived from human blood plasma, with hemostatic sealing and adhesive properties, ReliSeal mimics the final stage of the natural clotting mechanism. The kit is available in 1 ml pack size.   HemoRel A is a clotting factor VIII 250 I.U. preparation. It is indicated for replacement of Factor VIII in blood in patients in whom deficiency of Factor VIII activity is demonstrated i.e. patients diagnosed with Hemophilia A. Factor VIII replacement is the therapy of choice for clotting disorder in Hemophila A. The product pack is user-friendly and includes one 20 ml syringe, 2 needles, water for injection, syringe filter and spirit swab. It is administered by slow intravenous injection after reconstitution in 15 ml sterile water.   ReliPlasma is a pooled viral inactivated plasma for transfusion and is a safer substitute for fresh frozen plasma used for plasma protein replacement therapies. It is available in 100 ml bags in A, B, O and AB blood groups. ABO compatibility is a must for administration of ReliPlasma. It is safe due to the virus inactivation technology used in its production. It is the only brand of solvent detergent treated plasma in the country and does not require replacement donation.   As per a market research bureau survey, the glo- bal plasma sales for the year 2005 was estimated at $6.9 billion dominated mainly by five players-CSL Group, Baxter, Talecris, Grifols and Octapharma. These five account for over 60 percent of the global plasma sales. According to Arwind Sawant, Regional Manager (West), Hemophilia Federation (India), a self-help NGO run by persons with Hemophilia themselves, with help from medical fraternity, the prevalence of Hemophilia is the same all over the world, i.e. 1 person in a population of 10,000 suffers from Hemophilia. India having a population of more than 100 crore, it is estimated that 1,00,000 plus people are affected with Hemophilia. Unfortunately 25 percent of the world Hemophilia population lives in India. About 12,000 have been identified by us till now and registered with Hemophilia Federation (India). India needs about 9,00,000 liters of plasma proteins per year as per WHO estimates. India has been sourcing these proteins from MNCs like Baxter, one of the major suppliers of plasma proteins in the world. India has the market potential to look at manufacturing plasma proteins locally. But due to various factors no company has looked at this huge market until Reliance Life Sciences. "A team of four scientists worked for over three years on developing indigenously the plasma proteins. We have knowledge and experience in developing indigenously the plasma products by sourcing raw materials from the US, Europe and also using our own raw materials. On the technology front, we have the IP for these plasma proteins," said Dr Chandra Viswanathan, vice president (biologics), Reliance Life Sciences, who led the team in the development of plasma proteins. In 2005, Reliance Life Sciences successfully launched its indigenously developed first set of five plasma proteins-Albumin (AlbuRel); Immunoglobulin (ImmunoRel); Anti Hemophilic Factor VIII (HemoRel); Fibrin Sealant (ReliSeal) and Virus inactivated plasma (ReliPlasma), at 30-40 percent lesser cost compared to the imported ones. This will bring in some cheer among the Indian patients, as they will now be able to receive the blood proteins at competitive price. "Our objective is to be an integrated global biotechnology player and the first stop in this direction is the plasma proteins category of products," observed Mukesh Ambani, Chairman and Managing Director, Reliance Industries Ltd. He further said, "The plasma proteins range of products from Reliance Life Sciences will be followed by products in other categories, such as biogenerics, monoclonal antibodies, novel recombinant proteins and siRNA molecules, aimed at meeting unmet patient needs." Arwind Sawant noted, "Anti Hemophilic Factor is the lifeline of hemophilics and is not manufactured in India (Except for Factor VIII which is recently being manufactured by Reliance Life Sciences) and at present, we are importing from Baxter USA. We import factor VIII & IX. Since the cost is high, we are giving it at a subsidized rate of Rs 5.50 to Rs 6 to hemophilics. In the open market, Factor VIII is available at Rs 10 to 12. Factor IX is not available in the open market freely." On making the plasma proteins available at affordable prices, KV Subramaniam, president, Reliance Life Sciences, said, "These are indigenously developed proteins. There is no tech transfer involved. Even the scaling up has been done at our state-of-art facility. Moreover, it is our objective to offer the quality products at an affordable price to the patients." He continued, "At present our facility is equipped to produce 1,20,000 liters of plasma proteins per year. We are working on expanding the facility five-fold so that we can meet the unmet needs of the Indian patients and also patients from abroad." Sharing her views on the product reach, Medha Dhargalkar, vice president, business development, Reliance Life Sciences, said, "We were able to serve about 50,000 patients on an annual basis by reaching out to 10,000 doctors in India by offering the first set of five plasma proteins. We wish to reach out to five times of the present patient reach in the coming years." "The Award came as a surprise to us as we never expected this. However, compliments will encourage us to move ahead. We feel that it's beginning in the right direction," a delighted Dr Chandra Viswanathan said. Narayan Kulkarni "Plasma proteins are indigenously developed, leading to import substitution" How were the plasma proteins range of products conceived? Plasma proteins are used in critical life-saving conditions and situations such as Guillain Barre Syndrome, liver cirrhosis, burns, sepsis, traumas, major surgeries and clotting factor deficiencies. Until recently (till 2005), plasma proteins were almost entirely imported into India. Patients in dire need of plasma proteins faced several problems like nuncertainty in availability, short expiry of imported products and high price. In such a milieu, in the year 2001, Reliance Life Sciences (RLS) embarked on indigenous research and development of plasma proteins. RLS also built a pilot scale facility in Mumbai, compliant with Indian and international standards (WHO-GMP) for manufacturing these proteins indigenously. This is the only facility in India manufacturing these proteins. RLS introduced the first set of five plasma proteins from the year 2005 in the market place. These proteins are: Albumin (AlbuRel); Immunoglobulin (ImmunoRel); Anti Hemophilic Factor VIII (HemoRel); Fibrin Sealant (ReliSeal) and Virus inactivated plasma (ReliPlasma). What were the challenges you faced during the development phase of each of these products? All these products have been developed indigenously and the major challenge was in building the basic competencies and infrastructure. RLS pursued a number of developmental activities rights from identifying and getting on board the right set of competencies, instituting a rigorous quality assurance and quality control program, building a GMP compliant manufacturing facility, instituting appropriate molecular testing for viruses and incorporating viral inactivation technologies. Tell us about the team that developed these products. The team that RLS brought together under the leadership of Dr Chandra Viswanathan encompasses competencies in research, animal testing, manufacturing, quality assurance, quality control, validation, project management, product development and business development. The team was highly motivated with the mission of meeting unfulfilled patient needs and looks forward to developing many more products in this domain. How have these products made a difference to the country? These products are indigenously developed, leading to import substitution. Patients can get them at a short notice. Patients can be sure of the quality since it is coming from Reliance. Also, these products are 30-40 percent cheaper when compared with international price points for similar quality products. What are the USPs of these products and the market potential in India and abroad? The salient features of this indigenous research, development, commercial manufacture and clinical use are: Virus inactivated plasma introduced for the first time in India. This product, based on solvent detergent treatment process, developed by RLS, assures safety from transfusion transmitted infections such as HIV and Hepatitis B or C, which are critical issues in patient management. Fibrin Sealant introduced for the first time in India. Product safety with PCR screening at every major stage of production from raw materials to final product. Each and every batch of these products manufactured by RLS is released by the National Institute of Biologics (NIB), the governmental arm that is responsible for ensuring quality. At what competent price range are these available in the market in India against the existing products in the market? The product prices are typically 30 to 40 percent lower when compared to imported products from multinational companies. What are the future plans of Reliance Life Sciences in product development in the area of life sciences and biotechnology? RLS is now building a larger scale plasma protein manufacturing facility compliant with USFDA and EMEA standards. This facility would be operational in the second half of the year 2007. This facility would not only fully meet India's requirement, but would also cater to the needs of other geographies. RLS is also working on a range of specialty plasma proteins. When can we expect the next range of products from Reliance Life Sciences? Our scientists are working on recombinant therapeutic products, stem cell therapies, specialty plasma proteins, monoclonal antibodies, and also siRNA molecules. And we are hopeful of making them available to the patients by launching about eight products during the next financial year.   ]]> <![CDATA[Academic-driven Entrepreneur]]> https://biospectrumindia.com/news/95/2861/academic-driven-entrepreneur.html https://biospectrumindia.com/news/95/2861/academic-driven-entrepreneur.html Thu, 14 Dec 2006 10:37:00 +0530 Academic Academic-driven Entrepreneur Dr Villoo Morawala-Patell, founder and CEO, Avesthagen, is an academic-driven entrepreneur who has moved from high-powered academic research to the business world. Owing to her entrepreneurial capabilities, Avesthagen today has a steady revenue stream, a robust portfolio of technologies, services and products, as well as sophisticated collaborations with some of the most respected global business houses. This first generation-entrepreneur has been chosen the BioSpectrum Entrepreneur of the Year by the jury for all her accomplishments. No ingredient is more important to business success than innova tion, which is no long erregarded as the exclusive preserve of R&D, but rather as the best approach for managing the risk of today's uncertain business environment feels Dr Villoo Morawala-Patell, Founder and CEO of Bangalore-based Avesthagen. And truly so, it is this strong belief coupled with Dr Villoo's zeal for success that has nurtured the growth of Avesthagen from an R&D-based start-up to a well managed global company today. Dr Villoo Morawala-Patell began her professional career at the Hyderabad-based International Crops Research Institute for the Semi-Arid Tropics (ICRISAT) in 1978. She worked on projects on the biochemistry of nitrogen fixation in legumes, standardizing a screening technique for drought tolerance and on cytoplasmic male sterility in millet and sorghum, amongst other projects. After a ten-year stint at ICRISAT, at the age of 32, Dr Villoo decided to go for a PhD program in plant molecular biology at the University of Louis Pasteur, Strasbourg, France, after which she did a post-doctoral program at the University of Ghent, Belgium, at the labs of Prof. Marc van Montagu, who is one of the founding fathers of plant biotechnology. Incidentally, he is also on the scientific advisory board of Avesthagen. Moving back to India, she established herself as an independent scientist and principal investigator working from the National Center for Biological Sciences (NCBS) and subsequently at the University of Agricultural Sciences (UAS) in Bangalore. It was during this time that she received several prestigious grants from institutions like the Rockefeller Foundation, the Indo-French Center for the Promotion of Advanced Research (IFCPAR) and the UK Department for International Development (DFID). It was in 1998 that Dr Villoo founded Avestha Gengraine Technologies (Avesthagen) on the premise that the time was ripe in India to establish a research and discovery based biotechnology company, by making use of India's well educated workforce and abundant biodiversity at a time that large multinational life sciences companies had started eyeing the Indian market with increasing interest. "Avesthagen was one of the first and is still one of the few science and discovery driven life sciences companies in India, and has since matured through its seed and early stages into a rapidly growing and profit making operation," says Dr Villoo. Initially, the going was not easy. The company began from ground zero and obtaining finance was the biggest challenge. Fortunately, Dr Villoo's contacts in the scientific community around the world believed her venture had potential and chipped in to provide the initial funding. Subsequently, she approached venture capital firms (VCs) in India. Dr Villoo recollects, "Many VCs did not have a proper understanding of the biotech industry and dealing with them was a waste of time. However, I was able to locate suitable investors. The early investors came around 2000, who were mainly friends and family. It was in early 2001 that the company raised its first round of venture capital of $2 million." Avesthagen is backed by well-known investors such as ICICI Ventures, Oriental Bank of Commerce, Tata Industries, Godrej Industries, Cipla Ltd (all based in India) and bioMerieux, France. Currently, Avesthagen has 230 full time employees, most of whom are engaged in the R&D, product development and collaborative research programs. The company has diversified in the areas of life sciences research and product development, pursuing its vision to achieve convergence of food, pharma and population genetics leading to preventive personalized medicine. Thanks to Dr Villoo's entrepreneurial capabilities, Avesthagen today has a steady revenue stream, a robust portfolio of technologies, services and products, as well as sophisticated collaborations with some of the most respected global business houses. Namratha Jagtap Entrepreneur of the Year Dr Villoo Morawala-Patell Position: Founder and CEO, Avesthagen Age: 49 years Academics: Doctoral and post-doctoral qualifications in plant molecular biology from the University of Louis Pasteur (France) and University of Ghent (Belgium) respectively. Entrepreneurship: At the age of 45, Dr Villoo founded Avestha Gengraine Technologies (Avesthagen) with a mission to improve productivity in agriculture and develop agro-technologies that would lead to value addition in food and pharma products. Family: Her husband Zareer Patell is an icon on physical fitness (he's a nutritionist and a Black Belt in karate) and a jazz pianist. Her older daughter Farah is doing her Ph D at the Institute of Biotechnology, Cambridge University, UK, while the younger one, Sanaya, is doing her masters in neurobiology at the Boston University in Boston. Passions: Swimming, reading, writing, art and fashion. Other positions: Dr Villoo holds the position of Professor Emeritus, University of Agricultural Sciences (UAS), Bangalore. She was also the principal investigator and visiting scientist, NCBS at the Tata Institute for Fundamental Research (TIFR), Bangalore from April 1995. She is a member of Advisory Board for Biotechnology at Mysore University as well. Owing to her pioneering work in the field of molecular biology, Dr Villoo has long-standing professional relationships with individuals, institutions and corporates working in the domain of agri-biotechnology across the world. She is a member of the New York Academy of Sciences and also a key member of the Task Force and Vision group for Biotechnology, instituted by the Karnataka government. Awards and accolades: Recently, Avesthagen was declared a Red Herring Award winner for "disruptive innovation." The award recognizes that Avesthagen is an emerging star in Asia and follows a stringent evaluation of its business model, profitability forecasts, management team and technology. Owing to her pioneering work in the field of molecular biology, Dr Villoo has long-standing professional relationships with individuals, institutions and corporates working in the domain of agri-biotechnology across the world. Other hats: Dr Villoo has received several prestigious grants from institutions such as The Rockefeller Foundation, Indo-French Centre for the Promotion of Advanced Research (IFCPAR) and DFID. She has to her credit several joint patents in the field of gene discovery, gene functionality, gene transformation, bioinformatics and biotherapeutics. In the pipeline: A substantial pipeline of 11 biosimilar molecules is being developed in collaboration with Cipla Ltd for marketing by Cipla in India and aboard.   "We plan to go in for IPO in the latter half of 2008" What is Avesthagen all about? Avesthagen is about creativity. Avesthagen fosters collaborative and partner-embracing organizational culture in which innovation thrives. We believe in and are competent at bringing "new realities" into existence. Our systems biology approach to biotechnology is one such "new reality". Instead of starting with a molecule that might be therapeutic and hoping to find a disease target, a systems biology approach starts with a target or a disease phenotype and then logically develops a therapeutic. Avesthagen is a very conceptual and thought-provoking company with long-term intentions. We believe that rapid progress through our integrated systems biology programs will be instrumental in leading towards our goal of preventive, personalized medicine in the years ahead. While there will be drugs that do generate billion dollar sales, they will be the exception rather than the rule. Targeted therapies and personalized medicine is now the new mantra and biotech is at the forefront of a major shift in healthcare towards predictability-from drug discovery to the development of accurate molecular diagnostics and targeted treatments. With the healthcare industry maturing and expanding globally, changing market dynamics have provided both, challenges and opportunities for industry participants. At Avesthagen, we have built a robust portfolio of strategic partnerships, with market leaders across our different technology platforms as a means to address the challenges and capitalize on these opportunities. India is forging ahead in developing biosimilars, generic drugs, novel biopharmaceuticals, diagnostics and new seed. In addition, India has become a destination of choice for providing world-class research, clinical and manufacturing services to the global industry. Today, India is being touted as one of the key countries that will help drive the global adoption and acceptance of biotech crops in the future. Avesthagen is poised to lead this charge through its innovative "Seed for Food" and "Food for Medicine" programs thereby providing a multifaceted hedge against hunger, sickness and environmental degradation. You are aiming to become a global biotech company in the next few years. How do you plan to go about it? If you look at today's top 10 biotechs, they have revenues of $1-10 billion. So, Avesthagen has to fall somewhere in this range by the year 2015. The company has so far proved itself in delivering novel technologies and then finding global partners to allow these technologies to reach global heights. We clearly see our strengths on three counts in moving ahead: Established, cost-effective biologicals product development capabilities (laboratory as well as manufacturing base) Location-the largest emerging market is Asia Established network of collaborations with institutes and hospitals across the region to access new technology platforms and clinical studies Currently, we have about 230 employees and a substantial product pipeline of 11 biosimilar molecules (in cancer, autoimmune and cardiovascular disease segments) being developed in collaboration with Cipla Ltd. The first two products will be out in the end of 2008 and there after we will add on two products every year to our portfolio. This itself will take care of the $1 billion. The Indian biopharmaceutical business, presently estimated at $200 million, is expected to grow to about $3.3 billion by 2007-08, dominated by recombinant proteins, vaccines and monoclonal antibodies. The Avesthagen-Cipla tie-up hopes to capitalize on this opportunity as a base and catapult it into markets aboard. Avesthagen today has about 95 patents and is using its portfolio of patents to drive new deals. The patents cover a wide range of scientific technologies including transgenics, development of molecular markers, new methodologies, protocols, novel proteins and genes isolated from plants for therapeutic value. Each of these patents score high in terms of their scientific and technical merit and are certainly poised to provide maximum economic benefits. Two of our patents were recently globally evaluated and the valuation was pretty high. Avesthagen's value is not being ever linked to its revenues. And this is really one of the first such cases where revenue was secondary as compared to the reason why people pay the value to be associated with Avesthagen. So all this has added to what I want to call Avesthagen gravitas and we will definitely realize our dream of becoming a global biotech. What are your growth and expansion plans? In terms of management, in order to support and continue to effectively manage the rapid growth and development of the company, Avesthagen is in the process of strengthening its management structure substantially, both at the senior management level and the second line of management at the business unit level. In terms of infrastructure, Avesthagen in the last few years has grown to its present shape in its 11,500 sft headquarters and R&D facilities at the "Discoverer" building of the ITPL. In order to continue to cater to its rapid growth, and also provide for pilot scale manufacturing facilities for several of its product pipelines, the company has taken two additional facilities on lease. One is a facility comprising 12,000 sft of built up space about 2 km away from ITPL, where a cGMP facility for the pilot scale manufacturing of mammalian biotherapeutics is being established (as part of the JV with Cipla), as well as a pilot scale plant extraction facility for the FFM programs with Nestle and Avesta Nordic. At the same location, a new structure will be built to accommodate a biosafety level P3 laboratory for research on infectious pathogens in partnership with bioMerieux. As an interim measure to provide space to facilitate the growth of the company's activities, a second unit in ITPL has been taken up. Avesthagen has taken a 14,500 sft unit on the ground floor of the "Innovator" building. This unit will house the genomics, diagnostics and Seed for Food R&D and product development activities of the company, as well as some of the pharma related projects. In addition, the bio-informatics team and logistics, purchase and certain administrative activities will be relocated there. What are your other future plans? We plan to go in for an IPO. We will list in the latter half of 2008. Avesthagen needs big finance and it will go right down to the grassroots to raise its money. We will basically have quite a different style of IPO. It will be a knowledge and pipeline IPO. Who are your role models and what are the qualities you have imbibed? I would say the timelessness of Mahatma Gandhi, Nehru's vision of modern India, and JRD's implementation of that vision of a clean company with no compromises. So it is a mixture of the three. What they said... Dr Villoo Morawalla-Patell is one of the most resourceful biotech entrepreneurs I have known. She has built Avesthagen into a strong and innovation-led company and is a strong feature of India's growing biotech profile. I congratulate Villoo on this well deserved award and wish her continued success in the years ahead. Kiran Mazumdar-Shaw, CMD, Biocon Ltd It is indeed befitting that Dr Villoo has bagged this honor. She has been very successful in raising resources and building partnerships with global firms in creating a unique and multi-dimensional life sciences company. Her perseverance and indomitable spirit should set an example to any aspiring entrepreneur. Dr KK Narayanan, Managing Director, Metahelix Life Sciences A scientist of high caliber armed with excellent fundamental training in life sciences in India and abroad, Dr Villoo was one of the very few people in India at that time (over five years ago), to take on the challenge of entrepreneurship in life sciences.I congratulate her on winning the BioSpectrum Entrepreneur of the Year 2006 award. Dr Jagadish N Mittur, Director, Monsanto Research Center.     ]]> <![CDATA[Cotton King]]> https://biospectrumindia.com/news/95/2815/cotton-king.html https://biospectrumindia.com/news/95/2815/cotton-king.html Thu, 14 Dec 2006 10:35:00 +0530 Cotton King Cotton King Attur is a city and a municipality in Salem district in the state of Tamil Nadu, situated approximately 55 km to the east of Salem. Attur is the main shopping center for the surrounding countryside and is the capital of the "Attur Taluk" region, which is principally an agricultural area. Attur is also famous for tapioca (cassava roots), and there are several tapioca-based industries today which manufacture products like javvarisi (sago) for markets all over India. What is little known is that Attur is the third largest hybrid cotton seeds production center. This has been made possible by Muthu Gounder Ramasami, Founder and managing director, Rasi Seeds. What is even lesser known is the fact that the low-profile Ramasami is a champion of technology and disciplined farming. Ramasami is the BioSpectrum Person of the Year 2006, who is silently bringing about the next revolution in agriculture by taking the technology to the farmers. Rasi Seeds is a leading seed company in India with revenues in excess of Rs 300 crore. The second entrant to the most-watched Indian Bt cotton market, Rasi Seeds is credited for creating the demand for Bt cotton. In the 2004-05 cropping season, Rasi Seeds notched up sales of Rs 86.86 crore. And it more than tripled its sales in 2005-06 to Rs 309 crore. It has been the largest seller of Bt cotton seeds in India overtaking Mahyco. The success of Rasi has not come overnight. Muthu Gounder Ramasami founded the company in 1973. What is striking is the fact Ramasami does not hail from a business family. He hails from an agricultural family. He was born in Kallanatham village, near Attur town, completed schooling in Attur and went to do BSc Agriculture from Madras Agricultural College in Coimbatore. He completed his course in 1966 and joined the department of agriculture. The students of agriculture were very sought after during the 1960s and he got the job while at college itself. He worked with the department from 1966 to 1973. "That was the era when hybrids were introduced. Hybrid Bajra was a new crop and there was a high demand for it. I used to go to Bangalore and procure the seeds and gave it to the farmers. While doing so, I hit upon the idea to produce it. That is how I started producing the seeds, setting up Rasi as a partnership firm in 1973," said Ramasami. There was demand and he was enthused and passionate about doing something on his own. So he went on a long leave and started the seed production. Small quantities were produced and sold to farmers. But that was not sustainable as the margins were meager and the risks high. He then considered producing seeds for some big companies and broad based himself. He touched base with companies in Jalna. So he was organizing seed production from 19975- 80s. The cotton carrier started in 1975. "This is how I started," reminisced Ramasami. In 1973, when Ramasami decided to leave the department, his earning was Rs 450 per month. He left because of his passion for hybrids. "Hybrids were always attractive to me. I had the confidence that I could earn the amount equal to the salary that I was getting in the department through business. My parents, friends and relatives strongly opposed the move. But my wife realized that I was too passionate about it and supported me. She supported me all through the first 10 distressing years," recalled Ramasami. There were two bad phases during the initial few years, but he managed to sail over the bad phases because of his confidence. In the 1980s, the business stabilized and he was able to manage the family and educate the children. Why did Ramasami choose Rasi as the name for his company? Rasi, in Tamil, means a heap of fortune in the farming community. "It is also coincidental that the name has initials of my name and that of my wife's (Sivagami)." Also Ramasami's family did not belong to Attur. They migrated from Rasipuram. "Rasi as a name itself is a big component of my success," added Ramasami. Management in the field He started with a small retail outlet in 1969 (Attur Agro Service) with pocket money. But slowly developed it, pledging the jewels in the bank and rotating the money. "I never thought about how to grow it. I always focused on striking the right balance between earning and investing and be engaged in the activity. I did not have long-term plans. I never looked beyond two years of planning. However, today it warrants me to think and plan for a longer term of say five years," said Ramasami. His success has been owing to his confidence, say his colleagues Dr CP Thiagarajan, research manager, Dr S Ramanathan, vice president, crop research and Dr V Subramaniam, vice president, research. Ramasami always believed in intuition and took a logical approach in his endeavors. "I used to make a balance sheet of performance and prepare the next year's program. It was a logical approach. I learnt from my mistakes and quickly took the corrective measures." Ramasami's colleagues and staff confer that Ramasami is a man who loves to be in the research farms and see the hybrids growing. His strength lies in pooling the people and leverage on their strengths. He is gifted with the extreme ability to identify the strengths said Dr Thiagarajan. In fact, Ramasami is so passionate about visiting the fields that it is an important part of his daily routine. He visits his research farms every morning at 6 a.m in the morning and spends about an hour or so there when in Attur. Ramasami travels to Bt cotton fields across the country every month too. His management baptism has happened on the field. There is no single role model for Ramasami. He used to go about absorbing special qualities-timeliness (timely supply), quality parameters from some company, systems from some of the companies. Seed producing systems were taught by the Seeds Certification Agency. "These are some of the qualities that I have absorbed into my style of working." Belief in technology Rasi's big break came in 1992 when it released its first cotton hybrid. Till then it was producing hybrid cotton and hybrid jowar on a large scale and was organizer for companies like Mahyco. "All along, I never concentrated on the marketing activities up to 1990. I was an organizer to somebody. I felt that was not getting enough returns. So I wanted to release our own hybrids. I roped in director of research and scientist of repute, Dr R Krishna Murthy, who joined us in 1988. Dr Krishna Murthy, who developed LRA5166, promised to develop a good breeder seed. That was the starting point of our development. The first hybrid was introduced in 1992-93 and it performed very well and the volumes picked up by 1995-96. And by 1998 we were the top sellers of hybrid cotton. The marketing activity was also started in 1992 by my son, who joined me after his MBA. Now we have established links across nine states." Rasi has a massive R&D infrastructure. It R&D unit is recognized by the Department of Scientific and Industrial Research. The research farms are spread across 140 acres and the infrastructure includes 55,000 sft Green House, state-of-the art fiber testing lab (HVI), seed testing laboratory. Its cotton hybrids RCH2, RCH 20, RCH 134 and RCH 138 were among the top ranking hybrids in the All India Co-ordinated Cotton Improvement Project. And the infrastructure is being added on. He is spending Rs 6 crore on a new research facility and Rs 4 crore on processing unit. His scientists are also working on transgenic cassava, rice, brinjal, okra, tomatoes, etc. Ramasami is a strong believer of technology. This is reflected in all walks of his life not just hybrids and biotech. He is at ease using a mobile phone, laptop, a Sony digital camera, and many other gizmos. He is also diversifying and wants to make Rasi an integrated group. The outlined vision for Rasi is "Breeding to Branding". It aims to be across the entire value chain of breeding, contract farming, spinning, weaving, and garments. And he has the younger generation, his son and son-in-law, supporting him in accomplishing the dream. Ch. Srinivas Rao Person of the Year Muthu Gounder Ramasami Position: Founder and managing director, Rasi Seeds Date of Birth: September 12, 1944 Academics: Agricultural graduate from Madras Agricultural College, Coimbatore Family: Wife Sivagami supported Ramasami is all his entrepreneurial initiatives. Son R Rajendran, 35 years, is the executive director. Son-in-law, S Senthilnathan, 36 years, is now director, finance. The duo are all set to take Rasi to the next level. Daughter is a housewife. Other Hats: President of All India Crop Biotechnology Association; President of Tamil Nadu Seed Association; member of several associations like Association of Seed Industries, Seed Association of India, Seed Association of Madhya Pradesh, Seedsmen Association, Cotton Research and Development Association, Confederation of Indian Industry. Ramasami is also the chairman of Rasi Tex (In) Pvt Ltd, a textile mill.   "It was a tough decision, but it paid off" How did you enter the Bt cotton seed business? Bt cotton was commercialized in 1996 in the US and subsequently in Australia, South Africa etc. During the Asia Pacific Seed Association (APSA) meeting in Brisbane in 1997, there was a lot of talk on the Bt cotton. After the conference, Raju B Barwale of Maharashtra Hybrid Seeds Co. Ltd (Mahyco) came to our facility and asked us to consider Bt technology, as Rasi was a leader in the cotton seeds business at that point of time. I was very confused-the technology was new, the licensing itself needed upfront investment of Rs 50 lakh. But I made up my mind in favor of the technology after I attended the 1998 Athens meet of the World Cotton Research Conference. Scientists were highlighting the benefits of the technology. What really impressed me was the story of the South African farmers. The farmers used to travel for a distance of 2-3 km carrying water only to spray the cotton fields to protect from Bollworm attack. It is not an easy life for the farmers, more so for women farmers. By adopting the technology, the farmers in South Africa managed to increase the yield and reduce the pesticide consumption. It also made their life easier. After hearing about that case, I was fully convinced that I should enter into the agreement for Bt technology and at any cost. Yet, it took me about a year to complete the deal as Rasi was the first company that was entering a sublicense system. The terms and conditions of the agreement were new. The agreement was for trait value sharing in the ratio of 70:30 in favor of Monsanto and an upfront license fee of Rs 50 lakh. Whatever we collect from farmer as trait value is shared between the seed company, the technology partner and the marketing partner. In 1999, we paid an upfront fee and Rasi became the first company to vouch for Bt technology. We decided to transfer Bt gene to five of our hybrid cotton lines. And one of the prime reasons for Bt cotton's success has been the choice of the hybrids. What were the challenges that you had to overcome? It took over three months to get the Review Committee on Genetic Manipulation (RCGM) approval and by end of 1999, we got the initial seeds for conducting research on transfer of Bt gene for cotton bollworm resistance. That was the starting point of our Bt cotton entry. Monsanto provided us very good training and we established the lab at Attur. We had access to the St Louis headquarters of Monsanto and they helped us in transfer of technology to our hybrids. We got the permission for limited field trials in 2002 and the large scale field trials in 2003. Out of the five hybrids, only one hybrid, RCH 2 Bt cotton, was permitted for release in 2004. This was a very tense phase for me as I had bet all my money on Bt cotton and it took some time for me to reconcile. How did you manage it? I decided to be on the fields and focus all my attention on giving good guidance to the farmers. I always believed that farmers would come back to us only if they saw good returns. Further, there were a lot of dissenting notes with the first approval of Bt cotton in 2002. I realized the best way to address all this is through proper demos and by actively involving the farmers in every step, right from the selection of the hybrid. In 2003, we had gone for 475 trials in six states. We brought a large number of farmers to the field. We initiated the farmer visit program. All this created a good impression about the Bt cotton crop and the benefits. After the crop harvest, we started the farmers training program in a cluster of villages. Several lakhs of farmers participated in the six states. That is how we made ourselves ready for the market. Our RCH2 Bt cotton was approved in 2004. And in the first year, Bt cotton was grown in 4 lakh acres. We ensured that our field force worked in the field to see to it that the four lakh acres where Bt cotton was being cultivated gave success. In 2005, four more hybrids were approved, with the five products, 18 lakh acres could be covered. And with this, we really took off. In 2006, we had prepared 27-28 lakh packets. Were the farmers really ready for the technology? There was not much information available to the farmers. We had to understand the sentiments of the farmer before propagating Bt. Our field force was increased by four times to 400 for the promotion of Bt cotton. We forgot everything else and concentrated on creating the awareness. What really helped in our favor was that till 1998, we were leaders in cotton seed marketing. Rasi was a preferred brand and farmers knew about our RCH2 (especially those in Maharashtra, Gujarat, and Andhra Pradesh). It was highly popular and a high-yielding seed. So when the hybrid with Bt was introduced, there was no resistance even though each packet was priced at Rs 1,700 compared to the non-Bt one at Rs 400 as they had already seen the benefits during the field trials. Farmers have realized the value of the technology and hybrids and made an advanced payment for the seeds. Did you promote the technology on your own? All the programs were on our own. There was no joint promotion activity. We were very careful not to identify ourselves with any company. Monsanto was only the technology provider. One of the biggest challenges was in managing the expectation of the farmer. Our promos were aimed consciously at not increasing the expectations of the farmers. Our campaigns portrayed both the merits and demerits. How do you view the current pricing policy? The demand for Bt cotton has grown and the seeds command a premium price. Despite the fact that the prices were brought down from Rs 1,350 and fixed at Rs 750, dealers are not selling at MRP. Farmers buy it for Rs 1,000 per packet. It must be realized that the agro input delivery system is driven by dealers. The present pricing policy needs to be re-looked. Today, every seed company realizes that it cannot do business without Bt technology. Everyone is making an effort to get a very good germ plasm. It has created a very healthy competition. RCH2 was a benchmark. We are trying to scale up. I am working on improving on RCH2. To sustain this, there must be a change in the pricing policy in 2007. It should be value driven. For example, any company can sell the seeds at 75 percent germination (approved by the DBT). But companies are taking initiatives and are seeing to it that more value is added to the seed. This means a lot of additional efforts and more investments. So the pricing should be flexible and be based on quality. The technology provider can influence some discipline. This is the only way one can ensure a better technology to the farmer. ]]> <![CDATA[An Optimist and a Visionary]]> https://biospectrumindia.com/news/95/1434/an-optimist-and-a-visionary.html https://biospectrumindia.com/news/95/1434/an-optimist-and-a-visionary.html Thu, 14 Dec 2006 10:32:00 +0530 An Optimist and a Visionary An Optimist and a Visionary As the first "super star" of Indian science, Dr R A Mashelkar, has played a role much larger than the head of the massive CSIR network of laboratories. The biotech task force headed by him has charted out the course for a modern, efficient regulatory framework for biotechnology. And the dozen other high power committees headed by him in the last 15 years have propelled the country's amazing progress in different areas of high technology. An unabashed champion of liberalization and intellectual property rights(IPR), so crucial to the life sciences sector, this unassuming chemical engineer has left ever-lasting imprints in Indian biotechnology sector rapid progress to global glory by nudging, advising and of course clearing the various hurdles in its onward march. No wonder he was the unanimous choice of the BioSpectrum Jury for the Life Time Achievement Award as he hangs up his public administrator's role and takes up a mentor's role to inspire another generation of Indians. Dubbed as a 'dangerous optimist', Dr Raghunath Anant Mashelkar, Director General, CSIR, has the reputation of being someone who always sees the half full part of the glass and not the half empty. This attitude has been the key behind the saga of this extraordinary man who began his life in poverty, sometimes hungry and shoeless, but rose to become the Director General of the world's largest chain of publicly funded industrial research and development; the CSIR (Council of Scientific and Industrial Research) and the president of the Indian National Science Academy (INSA), which is the number one position for a scientist in the country. Humble beginnings Born in place called Mashel in Goa, he was the only child to his parents. Bereaved of his father at the tender age of six, young Mashelkar along with his mother came to Mumbai in search of a livelihood. "It was a tough childhood. I walked barefoot until I was twelve; studied under streetlights; getting two square meals a day was a problem," he recalled. In spite of all the hardships, he excelled in studies and made it a habit to top all through his academic career. "My mother did odd jobs, like stitching, to bring me up and to make sure that I got educated. The only way I could study was through scholarships, so standing first in the class became a necessity. What kept me going, however, was my mother's determination that I must study and achieve the greatest heights possible". His interest towards science was kindled early in life by his physics professor. "One day Principal Bhave, who taught us physics, took us outside the classroom to demonstrate how to find the focal length of a convex lens. He focused the sun's rays onto a piece of paper and told us that the distance between the paper and the lens was the focal length. Then he held the lens in place until the paper burned. That's when he turned towards me and said, 'Mashelkar, if you can focus your energies like this and not diffuse them, you can burn anything in the world!' I decided at that moment to become a scientist", shared the CSIR chief. Academic forays After earning a bachelor's degree in chemical engineering from Bombay University in 1966, Mashelkar pursued his studies towards a PhD at the University. He did post doctoral research at the University of Salford, UK, held a faculty position there and then had a brief stint in the US as a visiting professor. But in the mid 1970s, when attractive offers came his way for the faculty positions in top schools in the US and UK, he decided to return to India. In fact, the story of his return to India was very interesting. The late Dr Nayaduma, DG, CSIR during the mid Seventies, had gone to London to prospect bright Indian scientists working overseas at the behest of Mrs Indira Gandhi, the then Prime Minister of India. Mashelkar went to meet him at the Survey Hotel in London, spoke to him for about half hour and was filled with the dream of a new India. He accepted the offer on the spot and told his wife in the evening, "The nation is calling us, let us go back." Thus, returned the prodigal son of India and joined the National Chemical Laboratory, Pune at a salary of Rs 2,100. Bringing winds of change This internationally acclaimed chemical engineer took over as the Director of National Chemical Laboratory (NCL) in 1989. At 46, he was the youngest Director to take over the charge of this premier research laboratory. Dr Mashelkar brought in new concepts in research and technology management and moved NCL on the path of being a global R&D platform by offering its technologies and services worldwide. When Mashelkar took over as DG, CSIR, in 1995, he became the youngest Director General of CSIR at the age of 52. It was then that he single handedly revamped the organization and turned it into 'CSIR Inc': A public funded R&D institution with corporate style R&D and business plan. This initiative has transformed the organization into a user-focused, performance-driven and accountable organization. "We now have a very transparent and open working system. We see a new vibrant institution and more importantly, now CSIR has become Team CSIR: 38 labs working together," said the DG passionately. He has also been instrumental in propagating a culture of innovation and balanced Intellectual Property Rights (IPR) regime for over a decade. It was through his visionary campaign that growing awareness of IPR has dawned on Indian academics, researches and corporates. He spearheaded the successful challenge to the US patent on the use of turmeric for wound healing and also the patent on Basmati rice. These landmark cases have set up new paradigms in the protection of India's traditional knowledge base, besides leading to the setting up of India's first Traditional Knowledge Digital Library. In turn, at an international level, this has led to the initiation of the change of the International Patent Classification System to give traditional knowledge its rightful place. In post-liberalized India, Dr Mashelkar has played a critical role in shaping India's S&T policies. He was a member of the Scientific Advisory Council to the Prime Minister (1988-90) and also of the Scientific Advisory Committee to the Cabinet set up by successive governments. His dedicated and through style of working has won him over 40 awards and honors both in India and abroad. He is one of the eight Indians who have been elected as fellows of the America's National Academy of Sciences since 1863; Third Indian Engineer to have been elected as a Fellow of the Royal Society (FRS) in the twentieth century. The President of India honored Dr Mashelkar with Padmashri (1991) and with Padmabhushan (2000), two of the highest civilian honors in recognition to his contribution to nation building. In 2005 he received the Business Week (USA) award of 'Star of Asia' at the hands of George Bush (Sr), the former President of USA. Business India named him as being among the 50 path breakers in the post Independent India. Role models On being asked about his mentors, he replied, "I do not have a single role model. There are attributes that I like in different individuals. And I have tried to learn and imbibe from them. For example, Prof CNR Rao is one of the greatest scientists that this country has produced. I like his enthusiasm for science. He not only loves science but he lives science. Even at the age of 73 he puts in 18 hours a day. I have tried to imbibe his spirit. I look at my guru Prof MM Sharma, under whom I did my PhD. His memory is phenomenal and so is his value system-absolutely impeccable. I look at Prof R Kumar of IISc, Bangalore. I have rarely seen a more innovative and creative individual with greater incisive sense of analysis." "I look at Dr Ashok Ganguly, who was with me a member of the Science Advisory Council to the Prime Minister during Rajiv Gandhi's time. I love his optimism. He always saw the brighter side of the issue. He was always a part of a solution, not part of the problem. And finally my own mother, whose compassion for the poor, for the downtrodden is unbelievable. In short, I would say that I have tried to imbibe these three qualities of innovation, compassion and passion from these role models of mine." Summing his philosophy towards life and his achievements, Mashelkar said, "For everything that we do not have, we have to count what we have and make progress. I am also a great believer in thinking that the rest of our lives will be spent in the future and therefore, future is all that we should think about. My own personal life, the trials and tribulations through which I rose, has given me the confidence that anyone can reach this great height if one is at it." And this is also his message to the younger generation. The future Dr Mashelkar will be bidding adieu to CSIR on December 31 this year after a long and eventful stint but will remain active in the national and international science arena. In fact his 2007 calendar is fully booked. He will be taking up full time research at NCL as a CSIR Bhatnagar Fellow and will continue to be the President of INSA. He has also been elected the first President of Global Research Alliance (GRA), a forum of CSIR like institutions across the world, and will guide GRA to see how it can create a global knowledge pool for global good through massive global funding. Rolly Dureha   Fact File Dr RA Mashelkar Position: Director General, Council of Scientific and Industrial Research and Secretary, Department of Scientific & Industrial Research, Government of India Date of Birth: January 1, 1943 Academics: Bachelor's degree in chemical engineering from Bombay University (1966); PhD from Bombay University (1969); Leverhume Research Fellow, Department of Chemical Engineering, University of Salford, UK (1969-1970). Twenty five universities have honored him with honorary doctorates, which include Universities of London, Salford, Pretoria, Wisconsin and Delhi. Major Research Areas: Path-breaking contributions in transport phenomena in and thermodynamics of swelling, superswelling and shrinking polymers, modelling of polymerization reactors, and engineering analysis of non-Newtonian flows. Awards & Accolades: Dr Mashelkar has won over 40 awards and medals, which include SS Bhatnagar Prize (1982), Padma Shri (1991), Pandit Jawaharlal Nehru Technology Award (1991), GD Birla Scientific Research Award (1993), JRD Tata Corporate Leadership Award (1998), PadmaBhushan (2000), Material Scientist of Year Award (2000), IMC Juran Quality Medal (2002), HRD Excellence Award (2002), Lal Bahadur Shastri National Award for Excellence in Public Administration and Management Sciences (2002), World Federation of Engineering Organizations (WFEO) Medal of Engineering Excellence by WFEO, Paris (2003), Lifetime Achievement Award by Indian Science Congress (2004) and by Hi-Tech Pune-Maharashtra (2006), the Science medal by TWAS, the Academy of Science for the Developing World (2005), Asutosh Mookherjee Memorial Award by Indian Science Congress (2005). Other Hats: President of Indian National Science Academy; President, Global Research Alliance; President of the Institute of Chemical Engineers, UK; Fellow of Royal Society, London; Foreign Associate of National Academy of Science (USA); Foreign Fellow of US National Academy of Engineering; Fellow of Royal Academy of Engineering, UK; and Fellow of World Academy of Art and Science, USA. Papers and Publications: 236 papers in national and international journals; Written 19 books and has 28 patents to his name.   "21st century will belong to Asia and in turn to India" What has been the role of your family in your reaching iconic heights in this arena? The fact that I am sitting here in this office is because I was able to have higher education and do advanced research. You will be surprised to note that this would not have been possible but for the drive of my mother. When I finished my college, my mother insisted that I do engineering. When I finished engineering, she insisted I do my doctorate. When I got my doctorate, she had found out that there is something more: post doctorate. I had often wondered from where she got this kind of drive and vision to make me educated. And then, it came out during my 60th birthday. There was a symposium in Pune and a big facilitation. During the celebrations, a reporter from Marathi daily Sakaal interviewed my mother. Normally she never comes out and speaks publicly. But the tape recorder was on and my mother just opened up to this reporter. She told her a story which even I did not know. When she was young, she had gone to the Congress House in Bombay for a job. She stood in the queue for almost a day and when her turn came, she was rejected. That was because she did not have the minimum educational qualification and do you know what that was? It was passing the third standard exam. She could have easily lied. There are no certificates for the third standard exam. But she had never done that. That was one of the values she gave to me. While returning, she suddenly thought, 'Today, I am in this state mainly because I am not educated. I will make sure that my son gets the highest degree possible'. She did not know what that was but she wanted me to go as far as possible. That is how she has figured out about the post-doc. She was a remarkable lady, an unbelievable influence on my life. Unfortunately she passed away just a week ago in Pune, leaving a huge void in my life. What do you consider your most significant achievements during your tenure at CSIR? I would say it is the CSIR transformation brought about in the late Nineties. I am happy to see the warm applause CSIR transformation has received from across the board. Jayant Narlikar in his book The Scientific Edge (2003) lists the top ten achievements of the Indian science and technology in the 20th century and lists CSIR transformation as one of them. Soumantra Ghoshal, the Euro guru, who is no more, co-edited a book entitled World Class in India. He provided case studies of organizations which have managed the radical change, the best during 1991-2001. He covered CSIR transformation in a full chapter-along with Wipro, Infosys, etc. Business India has run a cover story on CSIR (July 1999) where they say-'CSIR labs have been transformed by the power of enterprise and proactive management'. We have received repeated accolades from the Prime Minister, Atal Behari Vajpayee, who had said in 1997-'...CSIR has regained its dynamism and prestige besides showing itself to be capable of standing up to the challenges of liberalization and globalization'. Similarly, Dr Manmohan Singh, our current Prime Minister said-'I would like to congratulate CSIR for the remarkable transformation into a performance driven and user focused organization. The entire CSIR team deserves to be complemented for achieving this feat. ....... I am happy that CSIR is flying higher and further'. Dr A Watkins of World Bank has said-'In my work in the ECA region, I have recommended CSIR as a model of how countries can harness their top quality scientific research institutions to the task of industrial technology development, innovation and global competitiveness'. What is your message to the scientific community? Let us realize that from the history of science we are moving to a new geography of science. There is a new atlas that is being drawn and in this atlas, India and China are going to be the dominant players in the 21st century. I believe that the 21st century will belong to Asia and, in turn, it will belong to India. In making this happen, Indian science will have a critical role to play. We must generate new science which can create new technologies and our aim should be to attempt creating a new paradigm of technology layer with 'Rapid Inclusive Growth'. Each of these is an important word. Growth is important, we are growing at eight percent and we can go beyond it. Inclusion is important from a sense that the benefits of science and technology must reach to all sections of the society. The word Rapid is important since the faster we move, sooner will we have people who are below the poverty line come above the poverty line. And all this can be done through technology which is based on new exciting science. What they said... I have interacted with Dr Mashelkar from very close quarters almost from the time he took charge as Director General, CSIR. He is a rare person who can peep in the future and could create a vision which has far-reaching consequences. His re-engineering of CSIR has also been exceptional and remarkable. He is a born optimist and essentially whatever he touches, flourishes. His great contributions in the areas of patents, population, development of drug industry in India as well as a common one window clearance for biotherapeutics. I have not seen many persons like him in my lifetime. He is a great mentor and supporter of not only within CSIR but other organizations and institutes. NK Ganguly, Director General, Indian Council of Medical Research   I have to say that Dr Mashelkar has served our country and the cause of science and technology with the greatest distinction. We all are proud of his achievements but I conclude by expressing the hope and prayer that perhaps we have not seen the best of him still-the best is yet to come. May his life and work continue to inspire generations of scientists and technologists in our country.          Prime Minister Dr Manmohan Singh     ]]> <![CDATA[BioSpectrum Awards 2006]]> https://biospectrumindia.com/news/95/2377/biospectrum-awards-2006.html https://biospectrumindia.com/news/95/2377/biospectrum-awards-2006.html Thu, 14 Dec 2006 10:29:00 +0530 BioSpectrum Awards 2006 BioSpectrum Awards 2006 The activity for the BioSpectrum Awards 2006, the fourth annual biotechnology industry awards, began in early October. An eminent jury panel comprising members representing the biotechnology industry, academia and the public sector was constituted in the first week of October. By virtue of being the Person of the Year in 2005, Dr MK Bhan, secretary, DBT, assumed the responsibility of heading the jury panel. Our practice has been that the winner of the Person of the Year award in the previous year, unanimously becomes the jury chairperson for the following year's awards. The jury The panel consisted of distinguished members like Nitin Deshmukh, head, private equity, Kotak Mahindra Bank, who has been working closely with this emerging industry for over a decade; Prof Samir Brahmachari, director, Institute of Genomics and Integrative Biology, brought in the academic perspective; Dr Krishna Ella, CMD, Bharat Biotech, represented the emerging private sector; and Dr KC Bansal, principal scientist, National Research Centre on Plant Biotechnology, IARI, brought the views of the research community to the fore. The two representatives from CyberMedia were Pradeep Gupta, publisher of BioSpectrum and CMD, CyberMedia and Abraham E Mathew, chief editor, BioSpectrum. The list of nominations along with the backgrounder of the nominees was sent to all the panelists via e-mail well in advance and the research support was provided by the editor of BioSpectrum, N Suresh along with Ch. Srinivas Rao, associate editor, BioSpectrum. With the stage set for choosing the biotech champions for the year 2006, the panel meeting was held at the DBT office in Delhi on October 30. The jury members had the onerous task of selecting the awardees for the Life Time Achievement, Person of the Year, Entrepreneur of the Year, and Product of the Year awards from a list of impressive nominations along with dwelling on the possibility of a Special Category Award. This award has been given only once in 2003, the year in which the BioSpectrum awards were instituted, to the State of Andhra Pradesh for its impressive forays in the biotech sector. During 2004 and 2005, the jury had decided against having any special category awards. Jury deliberations The jury panel was completely in sync with the selection of the award winners. Dr RA Mashelkar, director-general, CSIR, was the unanimous choice for the Life Time Achievement category. "Dr Mashelkar is the perfect example of a scientist and a policy maker who has reared and nurtured the biotech industry. He has been a prime mover in the biotechnology segment," said Dr Bhan. "This is the appropriate time to honor him as he is completing his term at CSIR this year," noted Pradeep Gupta. M Ramasami, managing director, Rasi seeds, which is currently India's largest Bt cotton seeds company, was chosen the Person of the Year. This was again a unanimous decision. "Ramasami's contributions to the Indian farming community have been invaluable. Besides supplying high quality hybrids in various crops, his company has put the Bt gene in a good background (cotton hybrid) which had greatly benefited the cotton farmers," opined Dr Bansal. In just two years Rasi has expanded its Bt cotton seed business to over Rs 300 crore. The jury members were in complete agreement with the selection of Dr Villoo Morawala-Patell, CEO, Avesthagen, as the Entrepreneur of the Year. She is a first generation scientist-turned-entrepreneur who founded Avestha Gengraine Technologies, which is focused on the novel concept of preventive personalized healthcare. "Dr Villoo has set up an impressive company with a sustainable business plan. She has been successfully forging alliances and coming up with products," said Nitin Deshmukh. Before the discussion on the fourth award category, the Product of the Year award, Dr Krishna Ella, stepped out of the discussion room as his company's product too figured in the list of nominations. This award was given collectively to five Reliance Life Sciences products, which the company recently released. These are AlbuRel, a plasma volume expander; ImmunoRel, purified immunoglobulin G; ReliSeal, a biological glue and hemostatic agent; ReliPlasma, inactivated plasma; and HemoRel A, which is the clotting factor VIII. Coming to the Special Category award, the jury members chose Kapil Sibal, minister for science and technology and ocean development, in consensus for the BioSpectrum Leadership Award in Biotechnology. All the jury members felt that the minister had gone beyond the call of his duty and given a stupendous boost to the life sciences sector since taking over as the minister in 2004. "Minister Sibal is the most articulate and global spokesperson for the Indian science and technology", said Prof Brahmachari. "He has promoted the Indian science and technology as a brand and positioned it on a special platform", added Dr Ella. In the next few pages, we have tried to capture the achievements of three remarkable individuals fired by their convictions and beliefs, a cabinet minister who had passionately championed the cause of Indian science and a team of scientists, whose dedication saw a number of excellent biotech products reaching the market in a very short time. Rolly Dureha   ]]> <![CDATA[#&naD:)!Tas]]> https://biospectrumindia.com/news/95/1075/nadtas.html https://biospectrumindia.com/news/95/1075/nadtas.html Thu, 09 Nov 2006 15:44:00 +0530 A case for Hepatitis B vaccine A case for Hepatitis B vaccine India's booming software exports are dramatically increasing the competitiveness of the world's leading companies and organization. The highly-export oriented industry finds few takers for its skills within the country and hence the Indian economy is under achieving its potential, despite the 8 percent annual growth. India's globally acclaimed vaccine manufacturers are in a situation similar to the software exporters. Take the case of Hepatitis B vaccine which can prevent the life-threatening infection at a fraction of the overall treatment costs if one gets that disease. Five Indian companies, Serum Institute, Bharat Biotech, Shantha Biotech, Biological E and Panacea Biotec, are among the world's most coveted suppliers of this vaccine. Their products are part of the Universal Immunization Programme in more than half the countries in the world. Together they have capacity to produce about 250 million doses of this vaccine every year. When Hepatitis B was introduced in the country's national immunization program on a pilot basis in 2002, the costs were high. Hence the government hesitated and there has been just about 7 million doses from these companies to vaccinate 2.3 million children every year. The prices of Hepatitis B vaccine has crashed so much due to high capacity build-up that it is sold at a throwaway price. So the government could easily include Hepatitis B vaccine to vaccinate all the 22 million children born in India every year. As a report in this issue, BioSpectrum points, the government and experts are unnecessarily worried about the cost of a basic vaccine like Hepatitis B at the cost of neglecting long-term adverse health conditions. Every new born child could get a shot of Hepatitis B along with other primary vaccines for less than Rs 100 crore annually. Indian companies can easily supply the entire Hepatitis B requirement and still meet their global commitments. Currently, only 2.8 percent of the Hepatitis B manufactured in the country is used within the national borders. While the whole world benefits from the Indian expertise, our own children are denied the benefits of this vaccine. Shantha Biotechnics pioneered the Hepatitis B manufacturing in the country and its founder Varaprasad Reddy has been crusading for providing the benefits of this wonderful vaccine to Indian children for nearly a decade. Bharat Biotech's Krishna Ella has repeatedly stressed the need to set up a National Vaccine Commission to formulate policies and ensure that India's young citizens reap the benefits of indigenous vaccines. Serum Institute's Cyrus Poonawalla has poured his heart out at many public functions about the callous attitude of Indian health establishment in neglecting the primary health of our nation's future citizens for want of imagination and compassion. It is not too late even at this stage. Under a World Health Organization (WHO) guideline, more than 150 of the 195 countries have included Hepatitis B in their universal child immunization programs. The product is available in plenty at highly affordable prices in the country. An affordable cold chain to ensure the supply of vaccine has also been developed by an Indian technologist, Rajendra Shende at the UN Environment Program in Paris. In fact, President Kalam has bought two of these "solar chill" plants and installed it at Rashtrapati Bhavan to demonstrate its effectiveness to the nation. The country has everything. For want of a few crore rupees in a booming economy, the future citizens of this country should not be made to suffer from a vaccine-preventable disease. <sureshn@cybermedia.co.in> ]]> <![CDATA[BioSuppliers Product]]> https://biospectrumindia.com/news/95/2044/biosuppliers-product.html https://biospectrumindia.com/news/95/2044/biosuppliers-product.html Thu, 09 Nov 2006 15:35:00 +0530 Bio Bio-Rad launches early dengue detection kit Bio-Rad India has launched a new test kit for dengue screening called the PLATELIA DENGUE NS1 Ag in the country. The PLATELIA DENGUE NS1 Ag detection kit, the first in the Indian market, is based on the specific detection of dengue virus NS1 antigen. While existing dengue tests identify the virus indirectly by detecting antibodies, which are produced only four to six days after the appearance of the first symptoms, the new test is able to detect the virus from the first day of symptoms. The kit has the ability to detect the presence of the NS1 antigen and this enables earlier detection of the infection compared to the conventional serological methods currently used. The time saving is at least six days for a primary infection. The test kit is registered in India and Bio-Rad has an import license to procure the kit to the Indian markets. The test performance has been confirmed through evaluations led by Bio-Rad teams as well as by reference laboratories of countries directly concerned by the disease, including India, Vietnam, Thailand, Singapore, Brazil and Guyana. For details, contact: sales.india@bio-rad.com   Honeywell releases Experion R300 Experion R300 is the latest release of Honeywell's Process Knowledge System (PKS), a unified system for process, business and asset management. Experion R300 is a reshaped and enhanced version of the field-proven automation and control platform hardware and software of the Experion PKS. This latest release is Honeywell's ongoing commitment to continuously innovate and provide solutions that protect customers' existing investments. R300 offers easy migration by allowing current customers to upgrade their systems without disrupting operations. The latest Experion PKS platform release provides a best-in-class redundant solution for the HART communication protocol, allowing plant operators and maintenance personnel full access to field device information directly through the Experion PKS platform. The HART solution improves system performance, increases process availability, safety, and throughput, while reducing life cycle costs for upgrading and maintaining smart field devices. For details, contact: deepu.tuli@honeywell.com   GE Healthcare introduces Ã„KTAxpress GE Healthcare has added Ã„KTAxpress, a new functionality that improves multidimensional purification of affinity-tagged proteins to its list of life sciences basket to meet growing demand from scientific community in life sciences space. Ã„KTAxpress is a solution for multidimensional purification of affinity-tagged proteins and antibodies. New functionality and updated software provides enhanced purification possibilities. The key factors of Ã„KTAxpress include Automated multistep purification which provides the highest possible protein purity. Multiple samples can be run simultaneously up to 48 samples in the twelve-module configuration and the new software makes it possible to purify proteins expressed at low levels and/or double tagged and off-column cleaved proteins. For details, contact: sachin.joshi@ge.com   Illumina releases new Genotyping BeadChip Illumina has launched two new BeadChips to its whole genome genotyping solutions- HumanHap300-Duo Genotyping BeadChip and HumanHap300-Duo+ Genotyping BeadChip. The HumanHap300-Duo Genotyping BeadChip is a multi-sample, whole-genome genotyping product that enables researchers to analyze two samples simultaneously using over 634,000 tag SNPs on a single BeadChip. The unique two-sample format makes this the ideal product for the analysis of matched (paired) samples from the same individual for both loss of heterozygosity (LOH) and comparative genomic hybridization (CGH) applications. While the HumanHap300-Duo+ Genotyping BeadChip is a multi-sample whole-genome genotyping product that enables researchers to add custom SNP content (60,800 SNPs per sample) and analyze two samples simultaneously using over 756,606 total SNPs on a single BeadChip (378,303 SNPs per sample). The HumanHap300-Duo+ BeadChip allows researchers to add virtually any SNP to the content of the HumanHap300 Genotyping BeadChip for either candidate-gene or population-specific research. In India, these products are being distributed by Haryana-based Premas Biotech. For details, contact: contact@premasbiotech.com   Additional Millicell offering from Millipore Millipore has introduced three products in Millicell range - 96 well plate, 24-well plate and new single-well hanging inserts for cell culture assays. These products are optimized to support suspension and adherent cell growth and differentiation. Additionally, the platform design enhances usability in a range of laboratory environments. The new hanging Millicell cell culture inserts are available in 6, 12 and 24-well sizes. Low throughput assays can be performed in the single-well unit. Design features include an off-center insert for easier media addition and removal. Standing inserts also are available. These inserts come with different pore sizes â€“ 0.4mm and 1.0mm; 4 different types of membranes â€“ MF, Isopore, PET and biopore. The 24-well plate is designed for maximum user convenience and includes features that maintain assay integrity. Additionally, the 24-well Millicell cell culture plate has twice the membrane surface area compared with other 24-well plates. This allows researchers to utilize greater cell mass, which more closely models cell behavior. The plates are automation compatible and reduce the risk of monolayer contamination with "footed" membrane plates that remain elevated when disassembled from the feeder tray and raised-well edges for better tape seating. Teardrop-shaped receiver wells eliminate air bubbles as plates are assembled. Both platforms incorporate track-etched thin film membranes for reliable monolayer formation, microscopically transparent membranes for easy cell visualization and fluorescent-compatible plastics and membranes. The 96-well Millicell plate is optimized to grow and sustain high integrity cell monolayers. Cells grown on Millicell plate membranes grow better than on plastic because the cells are nourished from both the apical and basolateral sides. Cell growth and function more closely mimics in vivo conditions. Millicell 96-well plates are designed for analysis as well as cell growth and can be used manually or with automated cell seeding, feeding and washing systems. For details, contact: rajiv_juneja@milliporeindia.com   ASTEC's CO2 incubator Symbiogen, a unit of Scigenics Biotech, has taken up the distribution rights of the Japanese company ASTEC for CO2 incubator and program temperature control system (for PCR applications) in India. Personal incubators from ASTEC are available in the capacity of 30L/50L. These water- jacketed incubators provide excellent temperature stability. High performance digital control system makes setting adjustments and calibration user-friendly. The automatic set up function automatically calibrates CO2 adjustment and then attains the set temperature and CO2 level. These incubators can be stacked 2 or 3 high to expand capacity, easily removable shelves, brackets, rounded chamber corners and HEPA filter ensures a contamination-free environment for the cell culture. A compact cooling unit can be installed for an extended temperature range of 10-50º C. The 50L incubator can house real time culture monitoring system. Standard accessories include door counter, automatic gas cylinder switch over system and two-phase gas regulator. For details, contact: info@symbiogeninc.com or visit www.symbiogeninc.com   Thermo develops advanced protein identification and quantitation software Thermo Electron Corporation has extended its protein identification and quantitation software package with the newly designed BioWorks 3.3. Featuring unique PepQuan capabilities, BioWorks 3.3 enables automated quantitative analysis of iTRAQ, SILAC and ICAT labeled samples, as well as label-free quantitation techniques. With new pre-search and post-search filters, BioWorks 3.3 removes unwanted spectra from the search resulting in faster search times, allowing users to focus only on the proteins of interest. Reporting and documenting results is also improved with the new software package. Spectra and tables can be quickly and easily transferred to Microsoft Office documents, while the new Protein Report feature enables printing of data directly from search results or the creation of PDF files. BioWorks 3.3 features the SEQUEST protein search algorithm, which automatically identifies proteins by comparing experimental tandem mass spectrometry (MS/MS) data with standard protein and DNA databases. It can analyze a single spectrum or an entire LC/MS/MS data set containing spectra from a mixture of proteins. The proprietary "cross-correlation" identification algorithm within SEQUEST extracts information and correctly identifies proteins even at low concentrations. Accurate mass capability is also incorporated in the new BioWorks 3.3 software package to enable SEQUEST searching on data acquired using Thermo's hybrid mass spectrometers. For details, contact: analyze@thermo.com or visit www.thermo.com/bioworks   ]]> <![CDATA[Chromatograpy Advisor]]> https://biospectrumindia.com/news/95/1451/chromatograpy-advisor.html https://biospectrumindia.com/news/95/1451/chromatograpy-advisor.html Thu, 09 Nov 2006 15:32:00 +0530 Chromatograpy Advisor Chromatograpy Advisor An industry overview Chromatography is one of the most powerful purification tools available to manufacturers, and its use can be seen across a wide array of industries. As a fundamental tool to detect, separate and purify substances, chromatography processes have been implemented into a number of manufacturing schemes. It is used to remove contaminants from foods and beverages, to separate unreactive complex hydrocarbons for petroleum applications, and to purify air and water. For the biopharmaceutical industry, advanced chromatography technologies are helping to solve some of the tremendous capacity challenges that face drug manufacturers. To meet the rising demand for biotherapeutics that are free of contaminating proteins, viruses, nucleic acids, enzymes, and enzyme inhibitors, processors need to be aware of the ever expanding capabilities of chromatography for drug purification. This article is the first in a series that examines some of the latest trends and technologies in process chromatography, particularly for biopharmaceutical manufacturers. This introduction provides a brief overview of some of the latest advances, and future columns will offer a more concentrated focus on specific areas of interest. Customizing chromatography There is a huge diversity of recombinant-based therapies that are being developed from different sources, from mammalian and non-mammalian animal cells, to transgenic milk, and from plant sources like corn and tobacco. This diversity requires customized chromatography processes in order to achieve the highest efficiency possible. In some cases a drug purification process can incorporate up to six separate chromatography steps. Fortunately, new innovations and advanced engineering can help manufacturers tailor the right solution for specific applications. For manufacturers of recombinant therapies, column chromatography is the most common-and most powerful-purification method for downstream processing. A variety of methods are employed, including affinity, ion exchange, hydrophobic interaction, and, to a lesser extent, immobilized metal affinity and gel filtration. As the number of drugs requiring high-doses and long-term administration continues to rise, there has been strong pressure to increase volume throughput at faster rates to meet demand. Column chromatography assemblies have become larger to handle increased capacity; currently the largest columns used in manufacturing are over two meters in diameter, and possibly even larger columns may be required at some manufacturing facilities. Column packing evolves into a science A number of innovations have taken place in column chromatography over the past ten years, particularly in the area of automation and process control. New precision controllers for mobile phase delivery and data acquisition, as well as advanced processing systems, have improved reliability and reproducibility. One area where automation has advanced the science of column chromatography has been in packing procedures. Packing media into chromatography columns was once considered a skilled, labor-intensive art that required extensive operator training to maintain consistency. However, even with the best-trained personnel, manual packing leads inevitably to variances that can compromise batch reproducibility. For the development of any regulated drug product, reproducibility is critical, and in cases where column packing is not up to par performance parameters such as product purity and yield are affected. In the worst case scenarios, batches can be ruined, resulting in huge cost overruns and production downtime. Column packing experienced a breakthrough with the introduction of pack-in-place automation in which a separate packing station suspends and then pumps media into fully-assembled columns. Pack-in-place promotes a homogeneous flow and packing of media into columns, and it leads to a better resolution of product from contaminants and recovery of eluted products in a more concentrated state. It also ensures that packed beds are more stable, improving consistency in batch-to-batch separations. Another benefit of pack-in-place automation has been to make processing more hygienic since operators utilize fully contained systems. All packing and Clean-in-Place (CIP) procedures take place without removing the top column assembly, eliminating the risks of contamination during the process, and in some cases preventing harm to operators when processing bio-hazardous materials. With the demands of higher throughputs, column repacking takes place more often, putting further pressure on operations to perform column packing more consistently. Today, over 70 percent of new column chromatography operations utilize pack-in-place systems. Improving process control and monitoring Recent innovations in hydraulic control of column packing procedures have helped improve consistency and reliability, especially for Flow Compression Packing procedures. Hydraulic linear actuators have been incorporated onto column systems to carefully regulate the compressive axial force that is applied to media beds. A pressure gauge monitors the hydraulic compression in a column, locking the column end cell in place when it has reached the level of the formed bed. Controlling the level of compression to be the same each time a column is packed helps ensure optimal bed density and maximizes the performance of media during packing procedures. It also improves batch-to-batch reproducibility. One of the most important developments in column chromatography is the use of ultrasound technology to monitor the density of packed media beds inside columns, which heretofore has been mostly guess work. Still in development, the use of ultrasound-aided column packing is poised to become commercialized, and it has the potential to offer operators an accurate diagnostic tool to measure how successfully a column has been packed, which has a direct correlation to its performance. Ultrasound detectors are sensitive to bed compression, mobile phase composition, and the presence of soluble components in the chromatography bed. Ultrasound can detect "real time" bed formation data that can be recorded and verified before a column is used. When used along with dynamic feedback control from a packing station, it can help ensure consistent and correct packing before a column is used. Membranes offer dynamic throughput Over the past several years there have been a number of developments in an alternative technology, ion exchange membrane chromatography. For many applications, membrane chromatography offers significant advantages in terms of speed and process economics. This technology utilizes microporous membranes with active chemistries on the membrane surfaces; this allows the active chemistry groups to be available for immediate binding. Membranes offer high dynamic throughputs because of their pore structure, which is chemically modified with charged, hydrophilic polymers on an open pore structure that provides much greater accessible surface areas for biomolecular binding than typical chromatography resins. Convective flow pores enable fast and efficient mass transfer as the fluid flows directly through the membrane pores, with no diffusional flow restrictions. Membranes have proven successful at process scale capture and removal of DNA, proteins, and viruses. A disposable, pre-packed membrane column can remove contaminants at 100 times the speed of resin-based column chromatography. In column chromatography, the surface area available for binding is mostly contained within the pore structure of the resin and is available only through diffusional forces. Large molecules and viruses cannot diffuse into these pores, and are limited to binding on the outer available surface area of the resin. Membranes, with no diffusional flow limitations, have a ten- to 100-fold higher capacity per unit volume than resins for DNA, viruses, plasmids, etc. Membranes also offer linear scalability, a critical consideration for manufacturers moving a product from laboratory to pilot and to production scale processing. Flexible disposable or reusable formats Membrane chromatography is available in disposable capsule or cartridge formats. Smaller laboratory scale devices are used for proof of concept studies, and for protocol optimization. For manufacturers this makes their use extremely flexible, since they can be added to existing process cycles, usually as a polishing step. Since membrane capsules are disposable, there is no cleaning or cleaning validation, which significantly speeds processing and reduces labor and buffer costs. Solution for gene vectors and viruses Membrane chromatography is much more efficient at capturing large molecules than column chromatography resins, and this is especially advantageous for large volume processing where a small mass of plasmid DNA or virus needs to be captured. Membranes are increasingly being seen as an enabling technology in the purification of genetic therapy vectors. Positively charged Q membranes efficiently bind plasmid DNA up to 23 kb in size, while the rapid processing times offered by membrane chromatography allow efficient purification of unstable large plasmids. Q chemistry membranes have demonstrated binding efficiencies of 1013 adenovirus particles per ml bed volume of membrane, with smaller results also being demonstrated in adeno-associated virus and lentivirus purification studies DNA and viral clearance breakthrough in manufacturing Membrane chromatography has also demonstrated effective removal of model viruses such as porcine parvovirus, hepatitis A virus, murine leukemia virus, and pseudorabies virus at removal efficiencies of 104 and 107. In one illustrative case where membrane chromatography has been implemented successfully as a post-purification polishing step, FDA and EMEA (the European Medicines Evaluation Agency) recently approved the incorporation of membrane chromatography to purify Aldurazyme® (larondiase), the enzyme replacement therapy manufactured by BioMarin Pharmaceuticals. When used in conjunction with a membrane-based size exclusion ultrafiltration process, membrane chromatography provides an orthogonal method of viral clearance, as stipulated by FDA and EMEA. This exempts BioMarin from DNA lot testing, marking a regulatory milestone in the production of protein-based drugs. In addition to saving an average of $2,000 per batch in processing, BioMarin has significantly reduced the possibility of a failed batch, which would be extremely costly, with human health implications. Wide-scale adoption of processes similar to this hold great promise for saving biopharmaceutical companies tens of millions of dollars in the manufacture of monoclonal antibodies and recombinant protein drugs. It is a unique yet telling example of how new chromatography technologies are helping manufacturers cope with processing and regulatory challenges. In future columns we will analyze in closer detail some of the new and improving innovations that chromatography is bringing to the marketplace.   Ian Sellick, Marketing Director, Pall Corporation/BioPharmaceuticals Note: This article has earlier appeared in Bioprocess International.   ]]> <![CDATA["Bio-Rad's dengue kit detects virus from the first day of infection"]]> https://biospectrumindia.com/news/95/1981/bio-rads-dengue-kit-detects-virus-from-the-first-day-of-infection.html https://biospectrumindia.com/news/95/1981/bio-rads-dengue-kit-detects-virus-from-the-first-day-of-infection.html Thu, 09 Nov 2006 15:30:00 +0530 New Page 1 "Bio-Rad's dengue kit detects virus from the first day of infection" -Dhiren Wagle, country manager, Bio-Rad India In an exclusive interview, Dhiren Wagle details about the recently launched dengue detection kit and the future plans of the company. Bio-Rad has recently released a dengue diagnostic kit. How different is it from the existing diagnostic methods and how is the market response to it? The existing dengue test kits available in the market identify the virus indirectly by detecting antibodies against the viral protein and confirm the presence of dengue. Thus tests with these diagnostic kits will show negative results till the fourth to sixth day of the infection. We have introduced the Bio-Rad Platelia Dengue NS1 Antigen kit which is very specific for dengue virus and detects it from the first day of the infection. The test, the first in the Indian market, is based on the specific detection of dengue virus NS1 antigen. So now the doctor has a tool via which he can detect the presence of the virus from the first to the fourth day of the infection, a very critical period, as the sooner the treatment starts, the faster is the patient recovery. The kit was developed by Bio-Rad in collaboration with the Pasteur Institute in France. The proprietary rights to the technology are with Pasteur institute but Bio-Rad is the sole licensee for this technology. We launched the kit in the early October and have got a lot of encouraging response. We are getting queries both from the government sector and also the private labs. What is the current focus of the diagnostic vertical at Bio-Rad? Within the diagnostics segment, we are currently focusing on four major areas: diabetes management via the HbA1c platform; thalassemia screening; quality control, where we offer products and quality assurance programs; and the blood banking sector. We will shortly launch products in the autoimmune segment. Of late, auto immunity incidents are increasing and there are not many diagnostic kits available to screen it. We have a complete panel and the automation, which will add value to this sector. Then, neonatal screening is another area which is picking up. There is a need for a lot of awareness in this segment as well. Even today these are seen in the country as esoteric tests, only for the elite and effluent. We have the test kits for galatosemia, congenital adrenal hyperplasia, and congenital hypothyroidism, among many others. These kits are based on the Elisa platform and are available from the bench level to the fully automated systems. These are disorders which can cause serious damage to the baby's health. Their early diagnosis will help the doctor to take a corrective step before the actual onset of the disease in babies prone to such disorders. Second, we are also creating awareness and education in these segments side by side as most of these areas are still state-of-the-art and a lot of labs are still using the earlier age, old home brew methods, as they call it. So we are trying to create awareness for physicians by running regular seminars/workshops for them in associations with the local medical bodies. Recently we tied up with the Quality Council of India (QCI), which is the apex body of accreditation. Along with them we have a joint program called the Bio-Rad QCI awareness program for quality control. We have done a lot of quality control programs in many cities like Lucknow, Chandigarh, Trivandrum, Pune and Kolkata. In the life sciences sector, what is the current strategy at Bio-Rad? We are focusing on a lot of growth in the new drug discovery segments like proteomics; biochromatography; and genomics especially on the amplification front. We have got a good response to the Bio-Plex product range, which has been the proven technology for identifying some of the key biomarkers for oncological research worldwide. We are about to launch the protein-protein interaction systems and will soon get into the area of protein identification, which would make our proteomics range complete. We are a total solution provider complementing and extending our earlier range of products in the gene expression, gene transfer, gene amplification space. We have also launched microarrays-slide printers, which is also doing well. Is Bio-Rad India expanding its presence in the country? We already have direct offices in Gurgoan, which is the headquarters, Mumbai, where we are expanding our office now, Chennai, Kolkata, Hyderabad, and Bangalore. Now we are expanding our infrastructure to serve the smaller towns better. We have sales and service teams in cities like Lucknow, Guwahati, Chandigarh, Trivandrum, Ahmedabad and Pune. We have also started a technical support hotline since some time. This is probably the first in the industry. It has a 1-800 number which is toll free and is managed by technically qualified personnel to trouble shoot any customer-related operational problems immediately. Rolly Dureha   ]]> <![CDATA[Multilevel counters slowly replacing beta counters]]> https://biospectrumindia.com/news/95/1920/multilevel-counters-slowly-replacing-beta-counters.html https://biospectrumindia.com/news/95/1920/multilevel-counters-slowly-replacing-beta-counters.html Thu, 09 Nov 2006 15:27:00 +0530 Multilevel counters slowly replacing beta counters Multilevel counters slowly replacing beta counters With increasing demand for multilevel platter counters, the sale of beta counters has taken a backseat. PerkinElmer and Beckman Coulter are the two major players in the beta counters segment in India. There are other smaller players too. "We are leading the market by selling about 30 units per year amounting to $1.5-1.6 million. We have a wide range of models from the basic to the automatic microplate-based units. The cost of each unit is ranges from $ 20,000 to 100,000 depending upon the model," said Yogeendra Dawalkar, sales manager-North, PerkinElmer Life & Analytical Sciences (Indian branch). Praveen Kulkarni, regional manager, PerkinElmer Life & Analytical Sciences, said, "PerkinElmer has 85 percent of the market share. The local indigenous players who are offering the beta counters at lesser price are meeting the rest of the market. The indigenously developed beta counters are available in the price range of Rs 1-1.5 lakh per unit. High quality and very sensitive beta counters from PerkinElmer are available in the price range of Rs 20â€“80 lakh per unit." Yogeendra Dawalkar said, "The market size for beta counters in India is about $2-3 million. It is more of a replacement market. This is not a very fast growing segment. Worldover, the research is moving away from use of radioactivity in studies due to the hazards involved although sensitivity-wise the studies are very good. In the global scenario, the growth curve of beta counters is flat while in India there is a slight increase in the sale of this instrument in the nuclear power sector." Echoing similar views, Praveen Kulkarni said, "There is a slowdown in the sale of these counters as the latest multilevel platter counters are in demand from the life sciences area because of their user-friendly and also their eco-friendly nature. These counters are available in the price range of $10,000â€“$40,000 per unit. There will be about 20 odd players such as Molecular Devices and BMG that are offering these multilevel counters in India." What is notable is that there are no repeat customers. This is mainly because of the disposal of radioactive substance in the solution although the measures are taken care of by the vendors. However, the companies have been using beta counters in the drug discovery research, to track the target in cellular studies in life sciences industry. In the interest of public health and safety, there is a growing need to quantitate the release of radioactivity into the environment. Alpha/beta liquid scintillation analysis (LSA) is a widely used method for the purpose of monitoring radioactivity from alpha and beta radionuclides. The alpha/beta LSA instruments from PerkinElmer deliver the advantages of high counting efficiency (~100 percent for alpha) and high thoroughput. Dissolving the sample in liquid scintillation cocktail completely eliminates the problem of attenuation. Besides disposal of radioactive substance, the other area of concern for the R&D institutes/biopharma companies is the high level of import duty levied on these counters. Praveen Kulkarni commented, "The volume of imports of beta counters are not much compared to other equipment used in the life sciences sector. At the same time, the number of users are also less. So I feel the government might not have thought of reducing the customs duty for beta counters. However, the industry should lobby for customs duty reduction for beta counters that play a key role in tracking the target in the discovery research space." Narayan Kulkarni ]]> <![CDATA["We expect golden rice to reach farmers in 2011-12"]]> https://biospectrumindia.com/news/95/1201/we-expect-golden-rice-to-reach-farmers-in-2011-12.html https://biospectrumindia.com/news/95/1201/we-expect-golden-rice-to-reach-farmers-in-2011-12.html Thu, 09 Nov 2006 15:26:00 +0530 New Page 1 "We expect golden rice to reach farmers in 2011-12" Prof. Ingo Potrykus is the co-creator of the famed golden rice. He is also the emeritus professor at the Institute of Plant Sciences, Swiss Federal Institute of Technology in Switzerland and is working for the deregulation of the golden rice. During a recent visit to India, Prof. Ingo Potrykus shared his views on the bio-fortification power of the golden rice and expressed concern over the delay in getting the regulatory approvals. Why has the golden rice not reached the ultimate end users as yet? I am deeply frustrated that the golden rice is still not in the hands of the farmers. It could take a long time to reach the people and the delay of every single year costs India alone between 5,500 and 39,700 lives. The key hurdle stalling the availability of golden rice is the regulation. Though the product (golden rice) is ready, it has still not been able to help save lives. It should be released as soon as possible. Why is there a delay in getting the regulatory approvals? According to me, the delay is hundred percent to be blamed on the regulatory system. Genetically Modified Organisms (GMOs) are regulated, although there is no scientific justification for this regulation. The argument for regulation is that the GMO technology leads to contradictory genome alterations. Although traditional breeding leads to massive contradictory genome alterations, it is not regulated and so the logic for the regulation of GMOs is beyond understanding. Since the regulation is firmly established around the world, from the moment we had the scientific breakthrough, which we wanted to give free of charge to the developing countries to help in improving nutrition, we had to do hundreds and hundreds of additional experiments to develop a product, which has a chance to pass through the regulatory process. To give you a few examples: Regulatory authorities do not accept materials that contain a selector marker gene. There is no scientific reason for this consideration. So we had to spend two years in breeding out the selector marker gene. The regulatory authorities have stipulated that there should be no unnecessary piece of DNA in the genome which means that the integration pattern has to be streamlined. So we had to produce thousands of events to screen for one event which has a streamlined integration and this took us another two years. And so on and so forth. There are numerous cases, where without any scientific justification the regulatory authorities have set a stage where years and years are lost for a product which could save lives. And that is why I am deeply frustrated. How soon do you think the golden rice can be made available? Assuming that the entire regulatory process will run on similar lines as with other GM systems, we expect the golden rice to reach the hands of the farmers in India, Bangladesh, Vietnam, Philippines, Indonesia and China in 2011-12. It will take so long because after investing six years into developing events that are amenable to the regulatory authorities, we can now start developing varieties. It did not make sense to have varieties until we had the right events to use as a basis for variety development. And then these varieties have to be deregulated. The variety development in India, Philippines, China and Bangladesh, Indonesia and Vietnam will take two to three more years. Then these varieties have to be taken through the full regulatory process. The technology was ready to be used in 1999 and if we would not have had the problem with the regulatory situation, plant breeders could have released the varieties in 2003 itself. So we are talking about eight years lost due to the regulatory process. If one relates the eight years to the fact that golden rice can save between 5,500 to 39,700 lives in India alone every year, one can see the consequences of regulations. I strongly feel that regulation does not protect people, rather regulation kills people. Since the last seven years, I have been trying to present this. I am not expecting anything in return. I just want to make the golden rice available as fast as possible for the developing world, which is proving to be very difficult. Many people have their apprehensions regarding the safety aspect of transgenic products. What are your comments? Why are people concerned about GMOs? It is because of the fact that GMOs are regulated. I am afraid that much of this concern in public, in retrospect, reflects that GMOs are heavily regulated. An unbiased citizen will automatically believe that if a government regulates a technology, as strictly as it regulates GMOs, there must be a reason for this. And scientifically speaking there is no reason. We have conducted extensive tests and now we have data from the first human feeding trials of the golden rice. From this data, we know that the bioavailability or the conversion to vitamin A is four times better than we expected. So now it is absolutely clear that even modest consumption of golden rice by children and lactating women will bring them out of the vitamin A deficiency status. The old Greenpeace argument said that the golden rice is not good because children have to eat far too much rice than they can consume is out. In fact, those children and women have to eat only part of what they normally eat in rice to have enough vitamin A to be protected. We have the results from three independent socio-economic studies done in the Philippines, Bangladesh and India. The study in India is the most extended one, which shows very clearly that the concept of bio-fortification for reducing weakness and malnutrition is very good. It is not only a biologically sensible approach, but it is probably the best available approach from the nutritional point of view and is by far the cheapest approach. The Indian study compared the cost for interventions against malnutrition and they arrived at surprising figures. The most effective intervention used in India so far is the free distribution of vitamin A capsules which is a sensible approach, but the cost of lives saved every year using this intervention is $168, which does not seem much, but if one uses golden rice, the cost is only $3. Golden rice is sustainable because it virtually costs nothing. The study also made clear that its potential in reducing vitamin A malnutrition in the Indian rice eating states is 99 percent. Where people eat rice it is enormously effective, if it has strong support from the government and is treated as a typical intervention. It should go into school meals and should be handed by the government by the other interventions also. It cannot be just left to the free market. It is critical on the whole, that the government uses its full capability of directing the product. At what stage of development is the golden rice now? We have transferred the trait to a series of carefully chosen argonomically successful Indica rice varieties in a number of different developing countries, and the trait is perfectly well expressed in all the different varieties. We have data from the initial field experiments done in the US, which shows specifically that the trait does not interfere with normal agronomic performances. So it is foreseeable that as soon as it passes through the regulatory procedure, golden rice will be successful. In order to encourage farmers to use golden rice, we are making sure that that this trait is combined with other valuable agronomic traits which are of interest to the farmer. Are you planning to introduce other traits as well into the golden rice? Golden rice has successfully demonstrated the power of bio-fortification. It has provided proof of concept that to improve the micronutrients content on a genetic basis, genetic engineering technologies are successful. So I think it is fair to say that the golden rice has got the concept of bio-fortification started and moving. We are now working on improving the golden rice by adding iron and zinc. I would like to see similar success with iron and zinc, as it is clear that these are even more burning deficiency problems. I am convinced that scientifically this would be possible and we are working on it. But it will not be deregulated easily. I have talked to numerous regulatory authorities about this concept and their reaction was identical.Under the present regulatory regime, it would not be possible to deregulate vitamin A, iron, zinc fortified in rice. Everyday nearly 24,000 people are dying due to various malnutritions. In five years from now, we will have rice with vitamin A, iron and zinc which could rescue many of those 24,000 people, but our GMO regulatory system will not allow this. What is your message to the scientific community working in the agriculture segment? The first message is that we have a deluge of molecular knowledge about plants, which is waiting to be used. I would love if some scientists had the interest to get them to work. It is far more convenient to work in the so-called "ivory tower" and most scientists are happy working there. My message to them is that they should take up some responsibility towards the society in addition to their academic work. My message to those few scientists who try to do something outside the "ivory tower" is that it is a very very tough job, far more difficult and demanding than research, leading to a pile of problems and frustrations. My message to the scientific community is that they should not only award scientists focused on academic research but also institute some awards for those who take care of humanitarian problems. In our academic environment, there is no mechanism and no funding for this type of work. And last, my message to the public sector is that the solution to humanitarian problems is your responsibility. It is not right to expect that the private sector will solve the humanitarian problems. The public sector should own its responsibility. Rolly Dureha   ]]> <![CDATA[Scientists developing new treatments for Alzheimer's]]> https://biospectrumindia.com/news/95/1349/scientists-developing-new-treatments-for-alzheimers.html https://biospectrumindia.com/news/95/1349/scientists-developing-new-treatments-for-alzheimers.html Thu, 09 Nov 2006 15:23:00 +0530 Scientists developing new treatments for Alzheimer Scientists developing new treatments for Alzheimer's British scientists have created a new chemical compound that could be developed into a drug treatment for Alzheimer's disease. UK researchers at the University of Liverpool have used a family of long chain sugars called Heparan Sulphates (HS), found on nearly every cell of the body, to produce a new compound that can prevent the formation of clumps of small proteins that form in the brain. The clumps disrupting the normal function of cells leading to progressive memory loss which is characteristic of Alzheimer's disease, are formed from a small protein fragment called Amyloid-beta (A-beta) peptide released from its "parent" protein â€“ amyloid precursor protein (APP), and the process requires the action of an enzyme called beta-secretase (BACE), critical in clipping up the APP to form the smaller A-beta fragments. The researchers have discovered that the HS sugars may play a key role in limiting the development of Alzheimer's disease. The sugars stick to the BACE enzyme and reduce its ability to "clip" the A-beta peptide, thus controlling the amount of A-beta peptide available to form damaging clumps in brain tissue. "We have developed a new class of compounds called 'engineered heparins' that could possibly be developed into drugs to stop A-beta peptides in the brain from forming and for the first time treat the underlying cause of Alzheimer's," leading researcher Prof. Jerry Turnbull was quoted as saying. The compound, based on the blood thinning drug, heparin, has modified chemical structures designed to optimize their desired activities and reduce potential side effects, and the compounds work by blocking the beta-secretase enzyme, responsible for snipping proteins into smaller fragments, he said, adding that despite its central importance to the disease, there are currently no drug treatments which target this enzyme because it has proved difficult to find inhibitors using traditional drug discovery approaches. The new compounds, based on the body's natural substances, may provide a novel route to effective treatments for Alzheimer's, the researchers said.   ]]> <![CDATA[The long-lasting tomato]]> https://biospectrumindia.com/news/95/2308/the-long-lasting-tomato.html https://biospectrumindia.com/news/95/2308/the-long-lasting-tomato.html Thu, 09 Nov 2006 15:21:00 +0530 The long The long-lasting tomato Using genetic engineering tools, Indian scientists have increased the shelf life of the tomato crop. Looking at the shooting prices of vegetables and fruits in the market, it is difficult to believe that India is the largest producer of fruits and the second largest producer of vegetables globally, after China. Annually the country produces 32 million MT of fruits and over 71 million MT of vegetables, which accounts for about 15 percent of the world's production of vegetables. However, it is estimated that about 30-40 percent of the total production of fruits and vegetables is lost due to spoilage at various post harvest stages. One way of reducing the post harvest losses is by increasing the shelf life of the fruits and vegetables. Worldover scientists have been adopting this approach to tackle the problem of post harvest losses. In India, Dr KC Bansal, principal scientist, National Research Centre on Plant Biotechnology, (NRCPB), IARI, along with his group has been working on extending the shelf life of tomatoes. He said, "Tomato is a very important crop for the country. It remains metabolically active even after harvest and under storage at room temperature leading to huge losses: spoilage due to over ripening, attack by bacterial and fungal pathogens. We cannot prevent this unless we have refrigerated storage facility, which India can ill afford at the moment. Instead, we can increase the shelf life of the tomatoes by using the biotechnology tools or delay the ripening process." Ethylene gas is the ripening hormone and is responsible for inducing ripening in most of these climacteric fruits including tomato. For ethylene biosynthesis, four enzymes are required and if the expression of one of these enzymes is knocked off, the pathway is broken and there is no ethylene production. So the global idea has been to curtail the production of ethylene by the antisense RNA technology where a gene responsible for one of the enzymes is put in the reverse/antisense orientation. Flavr-Savr tomato was the first product in the world based on this technology and the idea was to increase the shelf life. The Indian effort has been also on the same lines but with a significant difference. Elaborating on the technique used, Dr Bansal explained, "The idea in the Indian effort is to cut down the ethylene production not throughout the whole plant body but only in the fruit where ethylene is induced with the onset of ripening. If we use the CaMV 35S promoter, which most of the scientists have used, then the whole ethylene pathway is disturbed in different parts of the plant body as CaMV 35S is a constitutive promoter." So in order to curtail the amount of ethylene produced which starts picking up at breaker stage (the point at which 25 percent of the fruit begins to turn red) onwards, we used fruit-specific promoters. Also, when one uses a constitutive promoter, then the fruits will never ripen and in such cases farmers are advised to apply ethylene gas exogenously. But by using the fruit specific promoter, there is no need for any exogenous application of ethylene. Here the fruit will ripen automatically, but slowly, and will have extended shelf life." In the process, the scientists have been able to delay the shelf life by two or three weeks, which is a good time if the produce needs to be transported from one part of the country to the other and will not rot in the absence of refrigeration facility in rural households. Significantly, this is the first effort in the country to have successfully come up to this stage. Dr Bansal and his team have been working on this project since the last four to five years with the support from the ICAR and DBT. They initially cloned the necessary genes and promoters and made the required gene constructs to develop the transgenics based on the antisense RNA approach. Since the promoter is fruit specific, until the plant has gone to the fruiting stage, the gene construct behaves as a silent gene and is not expressed. Only when the fruit starts ripening, the gene construct becomes functional, acts in the fruit specific manner and there is no ethylene production. These findings were also studied by the scientists at the molecular level in the lab. Now they have successfully developed the transgenic in the elite cultivar of tomato of Pusa institute, known as "Pusa Ruby", which is ready for field trials after the necessary approvals are taken from the government. The trials at the Phytotron level have already been done which clearly show that there is a delay in ripening. The amount of loss that occurs annually due to the post harvest losses in fruits and vegetables runs into thousands of crores and with this technology we will be able to save losses worth Rs 1,000 crore annually in tomato alone. Besides, it will also help in diverting the surplus produce timely into the food processing industry" commented Dr Bansal. Sharing his larger vision for tomato project, Dr Bansal stated that his group may like to transfer this trait to some other tomato lines, which can be used in hybrid seed production. This will be undertaken with the help of tomato breeders within the Institute and the ICAR system and later they may also like to share this technology with the private sector to enter into a public private partnership. "We would like to spread the transgenic tomato throughout the country, with the help of breeders and the private sector." According to him, the product should be ready to hit the market in the next three to five years, if the regulatory approvals are obtained in time and the biosafety guidelines are not too stringent. Since there is no foreign gene, bacterial or otherwise, in this tomato, this timeline should not be difficult to achieve," he said. Another critical project on which Dr Bansal and his team are working is the nutritional quality improvement in tomato, which is also being supported by the DBT. The red color of tomato is imparted by "Lycopene", which is one of the best dietary natural antioxidants available. The lycopene content in Indian cultivars is much less as compared to its European or American counterparts and there is a lot of scope for improvement in the Indian cultivars. This project started about a year ago and is the only effort in the country to increase the lycopene content in tomatoes. Currently the scientists are studying all the 25 genes in the carotenoid biosynthetic pathway; lycopene is one of the products of this biosynthetic pathway. The aim is to understand the regulation of the gene expression in this pathway as the researchers want that there should be minimal or no disturbance to the whole pathway, except in the precise gene responsible for improved lycopene. Post this study, they will go for genetic engineering using the identified genes and promoters. "We have already identified a putative gene which is associated with increased lycopene content and have cloned that gene as well. Currently we are studying the regulation and interplay of all the genes involved," shared Dr Bansal. "Our final goal is to combine the increased lycopene content with extended shelf life, so that it is nutritionally enriched with better keeping quality. I hope that in a year or two, at the most, we would like to combine both the traits and in possibly three years time we will come up with another product that is having both the traits together," he added. This effort will go a long way in providing nutritional security along with affordability to the common man in India. Rolly Dureha   ]]> <![CDATA["Biotechnology is a key sector of New Zealand economy"]]> https://biospectrumindia.com/news/95/1461/biotechnology-is-a-key-sector-of-new-zealand-economy.html https://biospectrumindia.com/news/95/1461/biotechnology-is-a-key-sector-of-new-zealand-economy.html Thu, 09 Nov 2006 15:17:00 +0530 New Page 1 "Biotechnology is a key sector of New Zealand economy" - Brian Ward, CEO, New Zealand's Biotech Industry Organization (NZBio) Like in India, New Zealand's biotechnology sector is built on a century of world-class biological research. It has a long tradition of applying research to pastoral and arable farming, horticulture, forestry and human healthcare. New Zealand is now reaping the benefits of improvements in primary production, and from new high-value products. There are also a growing number of companies whose core business is biotechnology. These are high technology companies developing a range of novel products and services for global markets. The biotechnology sector will increasingly be seen as exciting, innovative and a distinctive New Zealand strength. New Zealand's Biotech Industry Organisation (NZBio) as the industry organization, has become an important force for developing industry policy and fostering regional, national and international networks and connections. In an e-mail interview with BioSpectrum, Brian Ward, CEO, NZBio, shared his views on the biotech industry scenario in New Zealand. Excerpts of the interview: What is the current biotechnology market scenario in New Zealand? The New Zealand biotechnology industry is developing quickly across a number of dimensions. New Zealand has always had a very strong research base and during the last five years we have seen an increase in momentum as a result of a much stronger focus on commercialization and greater critical mass. In 2005, $640 million was invested into biotech with more of this coming from private than public sources. During this time, 13 venture capital deals were completed and 11 companies raised money from initial or secondary offerings attracting $60 million of investment. Local venture capital funding has grown significantly in the last three years as has the interest from US-based venture funds. International collaborations and alliances are also on an upward trajectory. What are the focus areas in biotechnology? New Zealand has a traditional strength in agricultural biotechnology particularly in the areas of pastoral farming, horticulture, and forestry. Genetic and reproductive technologies are now being extensively used for improvement and selection. For example, in the dairy industry, Livestock Improvement Corporation is applying a range of genetic tests to improve milk yield and composition and in the sheep industry catapult is providing gene tests to improve muscling and fertility. While New Zealand will continue to place high importance on increasing farm productivity and reducing costs, there is a growing interest in using biotechnology to create new high value foods, ingredients and materials from primary products. Functional food ingredients derived from dairy and fruit are examples. The combination of an absence of many diseases and high trace ability standards means New Zealand is probably the world's most attractive place to produce high value therapeutics and biologicals from livestock. New Zealand is already a leader in the production of serum derived products and transgenic livestock for producing human therapeutics. In addition, in the human health area there are pockets of research excellence that have resulted in a number of world leading technologies and innovations. Particular strengths exist in carbohydrate based therapeutics (IRL), neuroscience (Neuren), asthma (Malaghan Institute), diabetes (Protemix) cancer (ProActa, Pacific Edge Biotechnology) and cell therapy (Living Cell Technologies). What are the incentives the government is offering to biotechnology companies and foreign investors? Biotechnology has been identified as a key sector of the New Zealand economy and the government is an active supporter of the industry. On top of being a stable cost competitive environment, improvements in the tax environment are underway including the implementation of a simple limited liability partnership model for investment. For companies, research and market development grants are available to assist in developing technologies that target high growth international markets. Government assistance is also available to assist in identifying partnering opportunities with New Zealand companies. Add to this an open culture that responds well to challenges and values high performance and you have a very good environment for biotechnology innovation. What advantages does New Zealand offer to biotechnology companies? New Zealand has a strong biological research tradition and we have been quick to apply molecular biology, gene discovery, functional genomics and proteomics to agriculture and human health research. Generally, New Zealand scientists are very resourceful and this continues to stimulate divergent thinking, which in many cases results in breakthrough solutions. The small size of the local industry has lead to a very well connected national network, which spans a wide range of disciplines and activities, and this has encouraged cross-pollination of ideas and provided very fertile ground for innovation. Within industry segments, New Zealand strengths in pastoral farming, horticulture and forestry are internationally acknowledged. There are emerging strengths developing in nutraceuticals/functional foods and biomaterials and pockets of excellence in human health. These strengths have led to a solid pipeline of novel technologies. What are the areas in which companies in New Zealand have an edge over the Indian biotechnology companies? I believe that there are opportunities to leverage New Zealand's discovery depth across the board and our agricultural strengths by establishing commercial partnerships with companies in Asia. These arrangements could take a range of forms and include development, manufacture and marketing. New Zealand companies are becoming increasingly global in their search for partners and Asia is firmly on their radar. There are definitely opportunities to create win-win situations for both sides. Are there any Indian biotechnology companies having presence in New Zealand or vice versa? To date the majority of New Zealand's biotechnology companies have looked towards North America for growth opportunities because these markets are the world's largest and most sophisticated. But this is changing as people realize that Asia is quickly emerging as a force in the industry and it is right in our neighborhood. At this stage there are a small number of companies with partnerships in Asia and I can see this accelerating and becoming increasingly common in the near future. For example, Pacific Edge Biotechnology has a development partnership with Medigen in Taiwan. What are the issues hampering the growth of biotechnology industry in New Zealand? A key issue for early stage companies is access to capital. While venture capital is developing in New Zealand, the industry is still very young. Similarly, New Zealand's public markets are risk averse and do not suit companies that are pre revenue. So this is a challenge, but also an opportunity for international investors into the New Zealand industry. It is also clear that in many cases New Zealand companies lack immediate channels to market for their products. To be successful they must pursue aggressive partnering strategies with major companies that have global reach to capitalize on the value of their technologies. International partnering is therefore an imperative. Narayan Kulkarni   ]]> <![CDATA["India has huge market potential for main and vegetable crops"]]> https://biospectrumindia.com/news/95/1437/india-has-huge-market-potential-for-main-and-vegetable-crops.html https://biospectrumindia.com/news/95/1437/india-has-huge-market-potential-for-main-and-vegetable-crops.html Thu, 09 Nov 2006 15:16:00 +0530 New Page 1 "India has huge market potential for main and vegetable crops" -Dr Yasheng Yang, president, Biocentury Transgene (China) Co. Ltd, China Biocentury Transgene (China) Co Ltd (BTCC) a public-private enterprise and enjoying the status of 'Jewel in the Crown' among agri-biotech companies in China was set up in 1998 as a Chinese company to promote Chinese Bt cotton technology. BTCC has emerged as the major technology provider of Bt cotton, as well as the main competitor to Monsanto. Last year BTCC emerged as the No.1 cottonseed company in China. In 2001, BTCC signed the first ever overseas agreement for technology transfer with an Indian seed company, Global Transgenes Limited (GTL), a sister concern of Aurangabad-based Nath Seeds, which launched its first Bt hybrids during the last kharif season in April -May 2006. Indeed, cross-border collaboration is gathering momentum. To oversee the progress of Bt hybrids in India, Dr Yasheng Yang was in India. He spoke to BioSpectrum about the agri biotech scenario and opportunities in China. Excerpts of the interview: If I am not wrong, at present Monsanto and BTCC are the only two leading Bt cottonseed companies in China... I would say mostly yes. We do have companies working on different kinds of Bt and insecticides. They get approval from the Chinese central government. But they are not so efficient. Monsanto is selling its Bt cottonseeds on its own in China. Last year, about 62 percent of the Bt cottonseeds sold in China were from BTCC. And Monsanto's sales were down by 30 percent. This year we are expecting it at 70 percent of the Bt cotton market. Our sales revenue from Bt cottonseeds for December ending 2005 touched 30 million RMB*. We are expecting the sales revenue at 70 million RMB this year. Besides private sector initiatives, we have institutes like the Chinese Academy of Agricultural Sciences working on agri biotechnology. Many institutes mostly in the public sector are working on developing genes against drought, pest, salt, cold resistance using Bt technology. Universities like Beijing University and China Agricultural University are actively involved in different crops, genes related to agri biotechnology. Agriculture and science and technology departments have been providing support to these public sector institutes in carrying out R&D activities. The funding for the research activities mainly comes from the Chinese central government and also from the provincial governments. Besides funding the projects, what other support is the Chinese government offering to agri biotech companies? In China we get two kinds of funding. The first is for R&D activities to develop technologies in the public sector. The funding for R&D activities comes mainly from the science and technology department of the central Chinese government. Every provisional government has science and technology department that funds mainly the R&D activities. The second fund is for commercialization. A lot of funds are available for commercialization purposes. There is no discrepancy between the private and public sector while disbursing the funds. Both will get the priority based on the merit of the projects. The central government has earmarked * $1.2 billion (10 billion RMB) for R&D for the next five years. The government has also been offering many tax benefits to the private sectors that are actively investing on R&D. For example, a company will get tax exemption if it invests 10 percent of its sales revenue in R&D. Affordability is a key factor when it comes to marketing of seeds to the farming community. What are your initiatives in this regard? The Chinese central government has laid emphasis on research activities and allocation of funds for biosafety studies and infrastructural preparedness related to commercialization of GM crops was not a constraint. This helped us to offer the Bt cottonseeds to the farmers at a much lower price. Our sales price for Bt seeds is very less compared to the competitors. Our high yielding Bt hybrid cottonseeds are sold at a retail price of 50-60 RMB (Rs 300-360) for a pack of 300-350 gm and the low cost Bt varieties are available at 25-30 RMB (Rs 150-180) per pack. This price is much lower than the Bt cotton available in India. The Chinese farmers are now saving about $270 per hectare by using our Bt hybrid cottonseeds. There is an increase of 5-10 percent in yields and reduction in the use of insecticides almost by to 2-3 times per season from the 14-16 times per season. The farmers are happy and we are also happy. What strategy has the BTCC adopted to take lead in the Bt cottonseeds sales in China? In addition to pricing, we are also supplying about 150 hybrids/varieties of Bt cottonseeds through an established chain of sub-licensees in the range of 40-50 companies across the country. Our competitor has only two varieties of Bt cottonseeds. And more companies are expected to join this chain in the coming years. Every year 50-60 hybrids/varieties of Bt cotton are added as sub-licensees of BTCC are launching newer varieties after getting the approval from the central government or the provincial government. Over two thirds of our sales is from Bt varieties while the rest is from Bt hybrids. Now farmers are being encouraged to go for hybrids, which are slightly on the higher side as compared to the varieties. What are your focused research initiatives at BTCC? We are mainly focusing on Bt cotton. Our other focus areas include Bt rice, cold resistant tree and grass. The second major Bt crop in China is rice. Why is rice the second priority? It is mainly grown in south of China where the climate is hot like here in India. The third area is cold resistant tree and grass. We are now working on large-scale field trials for Bt tree and grass. There is a very huge market potential for Bt tree and grass in China; mainly the demand will be from the government and also from the industry. Having an R&D team of 30, we are spending about 3 million RMB on R&D activities every year. Where do you see more opportunities in agri biotechnology after the successful joint initiatives between BTCC and GTL in the Bt cotton space? At present we are focusing on cotton and shown the technology on cotton. We have recently reviewed plans for the future. New insecticidal genes, other genes of interest and crops other than cotton are also on the agenda. We wish to work together in technology program breeding programs and also trials program with the GTL. We would be planning to set up several other programs to be in touch with Indian companies. What are your observations from your first visit to India? I visited three places in India - two locations in Hyderabad, three locations in Aurangabad and one location in Nagpur. During the field visits I came to know about spread of armyworm to cotton. We did not see much of armyworm in China. It seems to be a serious issue for cotton farmers in India. However, it is interesting to share this information that Biocentury's Bt cottonseeds are resistant to armyworm but I did not see that kind of resistance to armyworm from the competitor's Bt cottonseeds in the same location. What are your future plans for India? Well, India has very big area and is an agriculture country. Since both India and China have more population in common, more attention should be given on commercialization. It has huge market potential for main and vegetable crops. We do wish to have technologies with the Indian companies to get more market in future. We have a good partnership with GTL and wish to move forward. Narayan Kulkarni * Note: 1 RMB = about Rs 6 (to be precise - Rs 5.8) and US $1= 0.13 RMB   ]]> <![CDATA[Asia a global manufacturing hub]]> https://biospectrumindia.com/news/95/1325/asia-a-global-manufacturing-hub.html https://biospectrumindia.com/news/95/1325/asia-a-global-manufacturing-hub.html Thu, 09 Nov 2006 15:14:00 +0530 Asia a global manufacturing hub Asia a global manufacturing hub The Asia Pacific region has long served as a hub for low-cost manufacturing. With over 80 FDA approved manufacturing plants, India is only next to the US in terms of FDA approved facilities. Asia is, no doubt, a major center for manufacturng chemical based pharmaceuticals. It is a favored destination for contract manufacturing. But the biopharma manufacturing is small. According to a recent report published by HighTech Business Decisions, "Biopharmaceutical Contract Manufacturing: Best Practices Pricing Study 2006", between 2002 and 2006, the size of the biopharmaceutical contract manufacturing market is expected to double, reaching more than $2 billion in 2006, with revenues rising in tandem with contractors' new capacity coming online. To keep up with the increasing demand, which could reach a total level of one million liters of tank space required for contract manufacturing services, contractors are building, acquiring, and expanding capacity while making better use of existing capacity. Sandra Fox, president, HighTech Business Decisions, stated, "We spoke with 30 directors of biomanufacturing at pharmaceutical and biotechnology companies worldwide, and 16 biopharmaceutical contract manufacturers to document prices paid and prices charged in the industry. Of the total biopharma contract manufacturing market, only a small percentage of work will be conducted in Asian countries. Although small today, this percentage is expected to grow as pricing pressures in biotechnology markets increase and companies seek access to Asian markets. To meet this need, new mammalian cell culture facilities are being built in Asia and experienced biomanufacturing contractors are establishing operations in Asian regions." India and South Korea are emerging as the hot spots for biopharma contract manufacturing. Indian companies like Biocon, Bharat Biotech, Biological E, Serum Institute and Shantha Biotech have world-class facilities for biopharmaceutical contract manufacturing. Earlier there was some reluctance to contract to Asian biopharma manufacturers because of concerns of IP and regulatory compliance. But now some of the Asian countries are changing and becoming very competitive in biopharma manufacturing. According to Ernst & Young, Indian firms are expanding and scaling up manufacturing capacities to become global players. Companies like Biocon, Dr Reddy's Laboratories and Panacea Biotec are preparing generic versions of biotech drugs. In China too the case is similar. US FDA history Achieving GMP stamp approval from the US Food and Drug Administration (US FDA) is considered toughest in terms of its standards and efficiency. In 1963, the US FDA introduced GMP. It discovered contaminated large volume intravenous fluids manufactured by Abbott and McGaw Laboratories, which led to GMP revision in 1976. The 1976 revision remains unchanged until 2005. US FDA also ensures equivalence of Generic Drugs. The global pharmaceutical industry is an estimated $500 billion in 2005 divided into patented drugs, generic (off patent), prescription drugs and over-the-counter medicine. The industry is growing at seven percent to eight percent per annum. The US continues to be the leader while India's share is less than two percent of the global pharma market. An estimated 70 percent sales are made in the US and Europe. Since June 30, 2004, the State Food and Drug Administration (SFDA) has been closing down manufacturers that do not meet the new GMP standards. The Indian pharmaceutical industry ranks fourth in terms of volume and 13th in terms of value in the global pharma industry. China is the world's ninth drug market, and in 2008, it will become the eighth largest market. Manufacturing size The pharmaceutical manufacturing market is worth about $50 billion, out of which roughly 30 percent or $15 billion is outsourced. Active Pharmaceutical Ingredients (API) or bulk drugs outsourced market is worth $10 billion. One can classify API into three segments: branded prescription drugs, over-the-counter drugs and generic prescription drugs. With drugs worth over $50 billion going off patent in the next five years, the generic market will be the key driver of the global API market. It is expected that the overall outsourcing market will be about $30 billion by 2010. Currently India supplies API to about 50 countries worldwide. The demand for Indian APIs will increase year-by-year due to its quality and cost advantage. Indian manufacturers produced worth $1.5-$2 billion API in 2005. 70 percent of the total API manufactured is exported. Indian pharma tops The pharmaceutical manufacturing sector in India has come a long way in complying with the good manufacturing practice (GMP) set by World Health Organization (WHO) in 1968. July 2005 marks the beginning of new chapter in the Indian pharma industry. The GMP as per the Schedule M of the Drugs & Cosmetic Act became mandatory. Today, India has more than 800 GMP compliant manufacturing plants. There are more than 5,000 small manufacturing plants facing closure due to lack of expertise and capability. Today, Indian pharma companies have upgraded or building plants, which are not only GMP compliant but approved from international drug authorities. Many mid to large-sized ones have achieved GMP approval of highly regulated markets such as the US, Europe, Australia, Latin America and Canada. The most stringent, US FDA approval is distributed between large and midsize companies. India triumphs in having maximum number of US FDA approved plants after the US. India has 70 to 75 US FDA approved plants and all comply with WHO GMP. Out of this more than 50 percent are API manufacturing plants. Andhra Pradesh ranks first in having the most US FDA approved plants followed by Gujarat. Most of the plants got approvals without Form 483. The story does not end there. The number of US FDA approved pharma manufacturing plants is expected to increase by at least 30 percent in 2007, according to a study conducted by the BioSpectrum Advisory Services (BSAS). BSAS is a unit of BioSpectrum magazine. The large portion of the increase will be shared by mid size pharma companies. Most of the companies are upgrading and building new facilities as per US FDA standards. Apart from Andhra Pradesh and Gujarat, Himachal Pradesh is the next favored state for setting manufacturing plants. India comes fifth in terms of API manufacturing. It has established itself as low cost and high quality API production country. With product patent regime in second year and more than $80 billion generic expected to go off patent in two to three years, India is well positioned to capture the outsourcing opportunity. The US DMF filing has increased exponentially since 2003. Out of 4835 Type II active DMFs till Dec 05, India's share is 16 percent or 656. We expect DMFs filing for other countries to increase simultaneously along with the US. The ANDAs filing increased constantly from the year 2003 to 2005. We expect the trend to continue further. The ANDA filing is dominated by big pharma ones while midsize are too expected to increase the filing. BSAS research indicates an average of two DMFs and two ANDA filing per month with US FDA by most of the midsize ones, while big ones are expected to file more. Companies will also increase the filing to less regulated markets. In spite of having large number of US FDA plants and many others who are gearing up for inspection, there are a number of small companies who are yet to comply with GMP. Today, when GMP has become benchmark of quality, the smaller companies need to upgrade in order to survive and compete. The increasing number of US FDA plants will give Indian pharma an opportunity to tap the regulated (high and less) markets. On one side, Indian pharma companies are upgrading their facilities to meet the stringent US FDA stamp; we also see increase in patent filings and R&D investment. US FDA approved facilities comparison The number of US FDA approved facilities in India at the end of March 2006 stood between 71 and 75. India comes second in US FDA approved plants after the US. India has more than 800 WHO GMP compliant manufacturing facilities. US FDA facility growth in India BSAS expects India will have 30 percent more US FDA approved facility by the end of 2007 compared to March 2006. Most of the future US FDA approvals will be for midsize pharma companies.   ]]> <![CDATA[Bridging the industry-academia divide]]> https://biospectrumindia.com/news/95/2485/bridging-the-industry-academia-divide.html https://biospectrumindia.com/news/95/2485/bridging-the-industry-academia-divide.html Thu, 09 Nov 2006 15:13:00 +0530 Bridging the industry Bridging the industry-academia divide The DBT is making a move towards better technology management in life sciences in publicly funded research organizations in India. In order to boost the synergy between the industry and academia, the department of biotechnology (DBT) is currently working on the concept of technology management units to leverage the applied research and technologies developed by organizations/institutes in the public domain. This is indeed a welcome move. BioSpectrum spoke to some of the key players in the biotech industry and academia to seek their opinion and suggestions. The idea The technology management units will aim to fulfil the innovation gap in the country and act as a bridge between the industry and academia. It will boost commercialization opportunities to researchers, entrepreneurs, act as a resource centre for innovators and be focal point for the industry and researchers for further technology development. The USP of these units will be that they are solely focused on the life science technology management and will facilitate in commercialization of the technologies to the industry. The concept proposes to have a decentralized structure and will emphasize on local capacity building-strengthen technology transfer units in institutes where they exist and open such units in organizations/institutes where they are absent, driven by a HQ. The individual units will have a strong regional flavor to appreciate and capitalize on the strengths of the local institutes/research organizations and universities. It will create business opportunities for scientific innovation and would also help in spinning out new companies, in licensing of technology to existing companies or even facilitate in setting up new companies in case of stand-alone technologies. In addition to synergizing and enthusing the national biosciences scenario, the organization could also partner/tie-up with other global organizations engaged in similar activities. The unit will promote technology, its transfer and commercialization; IP facilitation and handling IP infringement; Developing technology evaluation mechanisms; Impart training and capacity building mechanisms; Organizing educational and workshops and seminars; Develop policies and mechanisms for technology transfer; provide a ready reckoner of available technologies available with the institutes and be in sync with the needs of the industry; create opportunities for entrepreneurs to network potential investors, partners, service providers, etc; facilitate interaction with VCs, law firms and corporations among others. A right step forward Lauding the initiative, Dr K VijayRaghavan, director, National Centre for Biological Sciences (NCBS), Bangalore, said, "Ten years ago, this would have been an interesting idea that could not be implemented. Five years ago, this would have been a good idea that only a few could implement. Today this is a great idea that no half-decent place can afford not to implement. The DBT will, I am sure, take this forward in an inclusive and implementable manner." Supporting the concept, Dr V Prakash, director, Central Food Technological Research Institute (CFTRI), said, "This is a good move and a big advantage to the public-private partnership model. We know this because the CFTRI does a lot of research in biotechnology, food science and life sciences and from experience we can tell that it is not actually easy for science to interface with the industry. That is why about 40 years ago, CFTRI established the technology transfer and business development department for building a bridge between the research being done at the institute and the industry requirements. This has been very successful in transferring a number of technologies to the industry and is a single technology-window from the institute to the outside world." According to Varaprasad Reddy, CEO, Shantha Biotechnics, "The idea of having technology management units within an organization/institute is excellent as it could function as an intermediary between the research organization and the industry. Such units would also be a one-stop unit for the industry to interact with, therefore would save on time. The National Institutes of Health in the USA has a technology transfer unit, which facilitates the transfer of technologies developed at NIH to different industries." However, he further added, "Although many of the academic organizations in India do have similar units already functioning, they seem to be more bureaucratic in nature. The industry would definitely love to work with such units if they function in a less bureaucratic way and ensure proper and complete flow of information to the industry." Concurring with Reddy's concern regarding the style of functioning of these units, another industry leader, Anuradha Acharya, CEO, of Hyderabad-based Ocimum Biosciences, said, "I think these units are a great idea as it will facilitate the differences between academia and industry. However, I have some doubts on the execution as there is currently a vast gap between the two. Nevertheless, this would be a great starting point to develop innovation in India and facilitate the fledgling Indian life sciences industry. The execution of these units could be run as a private sector initiative." Reddy also pointed out some essential criteria for the success of this venture. "In order to be effective, the technology management units in an organization should function: Independent of the institutional bureaucracy; Should ensure repeatability and the robustness in the technology; Should ensure technology to be free from IP infringement etc; Should ensure smooth transfer of technology to the industry; Should ensure regular trouble shooting during the process of technology transfer; and also after the complete transfer should work with the industry till the successful commercialization of the technology/product." Giving examples of such existing units in the Indian Institute of Science (IISc), Prof. G Padmanaban, distinguished biotechnologist, Department of Biochemistry, IISc, Bangalore, commented, "The concept of technology management units is welcome and overdue. Many Indian Institute of Technologies (IITs) and IISc do have such units. For example at IISc, we have two units, the Centre for Scientific and Industrial Consultancy (CSIC) and the Society for Innovation and Development (SID). In a broad sense, CSIC deals with short-term projects with industries, where as SID deals with long-term collaboration with industry. Most national labs would also have such units, although their contribution to promotion of locally developed technologies may vary. These need to be proactive in the sense of scouting for appropriate partner industries to leverage the technologies." Such units can improve their efficiency if they have a machinery to be fairly conversant with what is going on in the parent institution. As most often the existing units tend to become independent cells or departments and perform clerical functions. It would also help if these units could also provide help in identifying and evaluating potential discoveries for IPR protection and also take it further to generate documents for pat enting, pointed out Prof. Padmanaban. "Many universities in India may not have even rudimentary cells for technology management as conceived and they would benefit. The demands on such units would indicate that a wide-ranging expertise from science to financials needs to be available at these units and obviously most of it has to come from within the institution. If an appropriate structure for the units with a good, committed leader for each can be evolved, it would fill a long standing gap in the lab to land transfer," he added. Voicing the industry requirements, Dr Ashesh Kumar, general manager, biotechnology, of Mumbai-based M J Biopharm, said, "The academic research institutes may also ask industry of their immediate, mid term and long term technology needs and this may be considered by academic research to fine tune their applied research. In addition, the roles and responsibilities of these technology management units should be clearly defined and should include regular interaction with local/national biotech industry players." Citing the example of such existing units in other countries, he added, "Most of such units in Israel, Cuba, Europe and the US are termed as technology transfer group and many of the academic institution websites in these countries, which are successfully doing the tech transfer, make a regular update on what is available and what is coming and in what time-frame. This will be very important for the industry so that they plan their investments accordingly. Likewise the Indian institutes should also focus on regular and quick update on their websites." Good concept but not applicable However, some in the industry feel that though it is a good idea, this is not what the country needs at the moment. Naveen Kulkarni, CEO of Bangalore based Polyclone BioServices, commented, "The concept of technology management units is a very good idea, but this is relevant where there are ample technologies and discoveries available. In the current Indian life science industry most of the technology is either imported or adopted from an overseas collaborator. Before this unit can become relevant and have a role to play, we need technology development activities and this can happen only if there is enough basic research in the academia and applied research is encouraged in the industry. This trend is just beginning in India and is still less than a year. It requires at least another five years to assess the benefit of today's activities. There are many more hurdles to be cleared before we get there." Raising some tough but relevant queries, he asked, "What is the possibility of a company like Affymetrix or Illumina coming up in India? Do you think India can ever produce the Ciphergens, Sequenoms which have altered the course of global biotechnology industry. When was the last time India produced a technology that made a serious impact in the life science industry?" "My request is that let us focus on building the core competency and then we can think about managing that. Today we are talking about painting the wall without the wall," he added. Explaining his reservations about the success of such a venture, Dr JN Verma, CEO of Haryana-based Lifecare Innovations, said, "At present the Indian biotech industry can be divided into three groups-the start-ups, mid-size companies set up in the last five-10 years and the big companies. Now the big companies generally liaison with other multinational or foreign-based companies. The mid-size companies are very cagey in revealing their future plans and the start-ups do not know whom to contact, the required procedure, etc. Thus, this kind of venture will not benefit anyone in the industry. Another stumbling block in any government set-up (if this is set-up is under a government framework) is the bureaucratic system of functioning. This is big reason why the industry is hesitant about such partnerships." Instead proposing an alternate model, he suggested, "It will be more useful to have a consortium, in the life sciences segment where the Indian life sciences/biotech diaspora both in India and abroad can be the stakeholders. This can be linked to the institutional/academic sector as well which are a rich seat of libraries and instrumentation. In this way a public private partnership research centre can be developed which has the potential of getting a lot of business both from the Indian companies as well as from abroad. Hence a system can be evolved in which the scientific community/industry has not only interest but also a stake." Although there may be differences in the exact model to be adopted for better linking of the industry and the academia, it is noteworthy that a transparent, flexible and dynamic body will go a long way in synergizing and promoting both the pillars of the Indian life sciences sector. Rolly Dureha   ]]> <![CDATA[Immunization for all]]> https://biospectrumindia.com/news/95/2605/immunization-for-all.html https://biospectrumindia.com/news/95/2605/immunization-for-all.html Thu, 09 Nov 2006 15:12:00 +0530 Immunization for all Immunization for all The GIVS for 2006-2015 seeks to expand the reach of vaccination to every eligible person. Immunization is among the most successful and cost-effective public health interventions. In 2005, the WHO and UNICEF worked with partners to create a Global Immunization Vision and Strategy (GIVS) for 2006-2015. This strategy, which seeks to expand the reach of vaccination to every eligible person, is intended to be used as the basis for developing national comprehensive multiyear plans. GIVS articulates the WHO and UNICEF visions for global immunization in 2015 and is composed of four strategic areas: Protecting more persons in a changing world by improving routine immunization coverage, ensuring at least four immunization contacts per child, and expanding immunization programs to all ages; Introducing new vaccines and technologies; Integrating immunization, other linked health interventions, and surveillance in the health systems context and; Creating global partnerships to support and finance immunizations. Vaccination series Vaccines for measles, polio, diphtheria, pertussis, and tetanus have been part of the WHO recommended vaccination series since the inception of the Expanded Program on Immunization in 1974. In 1988, WHO recommended inclusion of yellow fever vaccine in routine infant immunization programs in countries with populations at risk for yellow fever. Hepatitis B vaccine was universally recommended for infants by WHO in 1992; in 1998, WHO recommended that Hib vaccine be included in routine infant immunization programs, where suited to national capacities and priorities. In January 2006, the WHO Immunization Strategic Advisory Group recommended global implementation of Hib vaccination unless robust evidence exists of low disease burden or overwhelming impediments to implementation exist. The WHO has not issued a universal recommendation for pneumococcal vaccine. The only licensed pneumococcal conjugate vaccine does not contain serotypes 1 and 5, which are responsible for a substantial proportion of severe disease in developing countries. Vaccines containing these and additional serotypes are under development. Estimated vaccination coverage By convention, the success of routine immunization programs in reaching children has been measured by the vaccination coverage achieved with the third dose of diphtheria-tetanus-pertussis vaccine (DTP3) among children aged 12-23 months. The WHO and UNICEF base estimates of routine vaccination coverage for all diseases (including DTP3) on review of administrative coverage data, surveys, national reports, and consultation with local and regional experts. Aggregated across member states, routine coverage with DTP3 ranged from 70 percent to 78 percent during 1990-2004. Substantial differences exist in DTP3 coverage among WHO regions. The European, Western Pacific, and American regions had DTP3 coverage of >90 percent in 2004, whereas coverage was 69 percent in the South East Asia region and 66 percent in the African region. Poor coverage in a region contributes to a high burden of disease and is reflected in the number of child deaths. Prevention of Hepatitis B virus infection is assessed by vaccination coverage with the third dose of Hepatitis B vaccine (HepB3) among children aged 12-23 months. As of 2004, a total of 153 (80 percent) of 192 WHO member states were using the vaccine. Of these 153 countries, 102 (67 percent) had HepB3 coverage of >80 percent, 36 (24 percent) had coverage of <80 percent, and 15 (10 percent) either had not reported coverage data or had not introduced the vaccine nationwide. Overall vaccination coverage with HepB3 is increasing and had reached 48 percent of WHO member states in 2004. Prevention of Hib infection also is assessed by vaccination coverage with the third dose of the vaccine (Hib3). Ninety-two (48 percent) of the WHO member states have introduced Hib vaccine since 1986; in 2004, a total of 78 (85 percent) reported Hib3 coverage of >80 percent among children aged 12-23 months. ]]> <![CDATA["India offers great potential for development of vaccines"]]> https://biospectrumindia.com/news/95/2644/india-offers-great-potential-for-development-of-vaccines.html https://biospectrumindia.com/news/95/2644/india-offers-great-potential-for-development-of-vaccines.html Thu, 09 Nov 2006 15:11:00 +0530 Hepatitis B vaccine will become an integral part of our immunization program Hepatitis B vaccine will become an integral part of our immunization program: PM "India offers great potential for development of vaccines" Vaccination is no longer seen as only an intervention to reduce infant and child mortality. It is also seen as a means to tackle diseases that occur in later life. The more common communicable diseases like malaria and rotavirus take a heavy toll on human lives. They also pose a serious challenge for developing countries and they emphasize the need for developing vaccines and for making them available at affordable prices. The Universal Immunization Program in India has had a major impact on all sections of society. With the introduction of this program, the disease burden due to vaccine preventable diseases has shown marked decline over time. Since 1975, there has been a 72 percent decline in the incidence of diphtheria, a 91 percent decline in the incidence of whooping cough, and a 61 percent decline in the incidence of measles. We are also close to interrupting the transmission of poliovirus in the country. But I would be the last one to argue that we can be satisfied with the status quo. No, we cannot be and we cannot rest on our laurels. We must do more. Even as we deal with old problems, new ones emerge. Japanese Encephalitis is pandemic in India and the Southeast Asian region, with high morbidity and unacceptable mortality. We face the growing challenge of HIV/AIDS. Here again, we need more investment in developing an AIDS vaccine. This is an important goal for medical research internationally, and for us in India as well. Given the continental dimensions of our country and the vast climatic and geographical variation, there are several constraints in the implementation of the Immunization Program. A top-down, over-centralized model does not work. A decentralized model is more effective. But there is scope for experimentation. And we must learn from the experience of all those countries where the programs have had a greater incidence of success. I do believe that we need to strengthen our public health systems, especially at the village level. We need also to place greater emphasis on preventive rather than curative solutions. Reaching 25 million infants and providing them the required vaccination in time remains the biggest challenge for our government. The immunization sector in India has been using glass syringes and needles. To improve the vaccine safety and safe injection practices in immunization and to bring about efficiency in the program, Auto Disable (AD) Syringes were introduced in 2005 with the support of the Global Alliance for Vaccines and Immunization (GAVI). The government is committed to continue the use of AD syringes. The immunization program was expanded to include Hepatitis B vaccine in the year 2002, in 33 districts and 15 large cities with support from GAVI, as a pilot project. In the year 2004, in the pilot project, 1.2 million children were vaccinated; with three doses of Hepatitis B. Very soon this will be expanded to 11 states, covering 11 million new-borns each year. We expect to make it universal and Hepatitis B vaccine will become an integral part of our immunization program. I do believe India offers great potential for the development of vaccines. We have some of the largest vaccine manufacturers in the world. India supplies more than 60 percent of world's requirement of basic vaccines, as procured by UNICEF. This is made possible due to our ability to produce quality vaccines at reasonable prices, affordable by many developing countries. Biotechnology is a rapidly developing sector in India. Our pharmaceutical companies have already helped in drastic reduction in prices of anti-retroviral drugs for the treatment of HIV patients. Production by Indian manufacturers was the key factor in reduction of price of Hepatitis B vaccine in the world about eight years back. This paved the way for rapid introduction of low-cost vaccines in most countries of the world. This story is being rewritten with the production of combination vaccines by Indian manufacturers from this year. India can become the hub of vaccine production for the developing world. Note: The above text has been extracted from the keynote address delivered by the Prime Minister, Dr Manmohan Singh at the Global Alliance for Vaccines and Immunisation (GAVI) Partners' Meeting in New Delhi on December 7, 2005. ]]> <![CDATA[India to eliminate polio by 2007]]> https://biospectrumindia.com/news/95/1873/india-to-eliminate-polio-by-2007.html https://biospectrumindia.com/news/95/1873/india-to-eliminate-polio-by-2007.html Thu, 09 Nov 2006 15:09:00 +0530 India to eliminate polio by 2007 India to eliminate polio by 2007 Since the initiatives to eradicate polio from India started in 1995, significant success has been achieved in reducing the number of polio cases in the country. As against 1,600 cases in 2002, 134 cases were detected in 2004. There has been 92 percent decline in Polio cases recorded between 2002 and 2004. The geographical spread has also declined from 159 districts in 2002 to 87 in 2003. By the year 2004, the virus could be restrained to only 43 districts mainly in Western UP and Bihar. During 2005-06 (upto February 28, 2006) only 66 cases were confirmed. Out of the 39 cases detected so far, 30 cases were detected from Bihar and 29 cases from Uttar Pradesh. The geographical spread has been limited to only 35 districts mainly in western UP and eastern Bihar. In view of predominance of Type 1 Polio virus, the government of India has revised the strategy for use of monovalent OPV 1 in the state of Uttar Pradesh, Bihar, Delhi and Mumbai, based on the advice of WHO and other experts. Monovalent OPV 1 vaccine was indigenously made available in a record time. In order to reach every eligible child during the pulse polio round, apart from the strategy of vaccinating children at fixed booths and house-to-house visit, efforts in vaccinating children in transit at railway stations, inside long distance trains, major bus stops, market places, religious congregations and major road crossings throughout the country have been intensified. Through these efforts, five million children in transit have been effectively administered polio drops from May 2005 immunization rounds. Strategy for polio eradication The government is keen to eradicate polio from the country and also decided to rehabilitate the polio-affected children. And it has formulated a strategy with more funds. The union minister for health and family welfare, Dr Anbumani Ramadoss said that the government intends to eliminate polio from the country by 2007. In this regard, the Cabinet committee on economic affairs, government of India on June 29, 2006, approved funds to the tune of Rs 1,039 crore for implementing the polio eradication strategies in the year 2006-07. The number of SNID rounds in high-risk states/areas and their coverage each year will depend upon the recommendations of Indian Expert Advisory Group (IEAG) made from time to time. Similarly, mop-up rounds could be recommended by IEAG in case of occurrence of polio cases in non-SNID states. In view of this, the Department of FW will be allowed to adjust and modify the strategy, including revising the number of SNID rounds and their coverage, converting NID into SNID or vice versa and also conduct mop-up rounds in non-SNID states in accordance with IEAG recommendations and implement the same within the overall outlay of Rs 1,039 crore. The Cabinet committee on economic affairs also gave its approval for corrective surgery and rehabilitation of the polio victims and to equip them to earn their livelihood and lead a dignified life in the community. For this activity, Rs 20 crore has been earmarked. As per the data available with the National Polio Surveillance Project (Joint Venture of WHO and government of India), it is estimated that there are about 20,000 such children in the country. Each child will get an average of Rs 10,000 for corrective surgery, fitment of prostheses, calipers/boots of good and light quality and residency and training of victim and attendant for treatment and physio-therapy period. Elimination of polio will improve the quality of lives of those otherwise affected by polio involving life-long disability, thus improving national productivity and eliminating wasteful expense on treatment and rehabilitation. ]]> <![CDATA[China immunizes 11.1 million children against Hep B]]> https://biospectrumindia.com/news/95/1936/china-immunizes-11-1-million-children-against-hep-b.html https://biospectrumindia.com/news/95/1936/china-immunizes-11-1-million-children-against-hep-b.html Thu, 09 Nov 2006 15:07:00 +0530 China immunizes 11 China immunizes 11.1 million children against Hep B Since 2002, China has immunized 11.1 million children in the country's poorest and most remote western and central provinces against hepatitis B, reducing their risk of developing a deadly and common liver cancer, according to an announcement made by the Chinese government and the GAVI Alliance. The boost in immunizations in China represents a 60 percent increase in hepatitis B vaccine doses delivered to children in target provinces. The children reached include newborns, who receive a â€œbirth doseâ€? of vaccine plus two more doses at one and six months of age, as well as previously unvaccinated children under five, who must also receive a full three-dose vaccine series, according to a release from GAVI. â€œOur goal is to protect all the babies at birth from this virus,â€? said the Chinese minister of health, Gao Qiang. â€œThe China-GAVI hepatitis B Immunization Project has propelled us forward on this path, covering one-third of all children born in China since the project began in 2002.â€? According to an estimate based on a 1992 national hepatitis epidemiological survey, 120 million people in China are chronically infected with hepatitis B (HepB). Those infected are at risk of liver cancer or failure, and can spread the disease to others. In the western provinces, the campaign, with technical guidance from the World Health Organization (WHO) and UNICEF, has reached almost 70 percent of newborns with a birth dose of vaccine in 2005, up from 47 percent in 2002. Newborns are a key target of the effort, since vaccination within the first 24 hours of life is the only way to protect an infant from transfer of virus from an infected mother. Since its inception, the campaign has averted over 200,000 future deaths due to the chronic consequences of hepatitis B, mainly from cancer of the liver and cirrhosis. Death typically comes decades after children are exposed to the virus during childbirth or in their first years of life. The breakthrough is the result of a five-year $76 million project, co-funded equally by the government of China and the GAVI Alliance (formerly the Global Alliance for Vaccines and Immunization). Known as the China Ministry of Health/GAVI hepatitis B Vaccination Project, the GAVI-supported campaign has targeted newborns and children under five across an area that encompasses 470 million people, including six million newborns every year. It has reached babies born in hospitals, as well as those born at home in mountain villages or in the tents of nomadic herders on the vast steppes. â€œThis breakthrough was 20 years in the making,â€? said Julian Lob-Levyt, executive secretary of the GAVI Alliance. â€œThat is how long children in the industrialized world have had a vaccine to fight this virus, but, until recently, progress in emerging countries and poor remote areas, such as western China, had been painfully slow. China's success is a model for other countries still struggling to stop the spread of the hepatitis B virus and other vaccine-preventable diseases.â€? According to preliminary data, provincial governments have added to the funds provided by GAVI and the central government, contributing more than $10 million in co-payments. Lob-Levyt noted as well that the support of the World Health Organization (WHO) and UNICEF has been critical. â€œWorldwide, GAVI's support has made it possible to immunize 90 million children against hepatitis B and avert an estimated 1.4 million deaths from this disease alone,â€? he added. Homegrown vaccine and dedicated partners Progress in China has been the result of national commitment to control this disease; strong partnerships; new national laws; and a homegrown vaccine industry able to supply the huge quantities of vaccine needed. The government of China and the GAVI Alliance embarked on the five-year project in 2002, with the goal of reaching 75 percent of newborns with a birth dose of vaccine and 85 percent of children under the age of 12 months with all three doses of Hep B vaccine necessary to prevent infection. GAVI financial support was used to purchase and distribute 55.39 million doses of hepatitis B vaccine and 145.6 million safe, auto-disable (AD) syringes. That financial support was also designed to catalyze national action and sustained commitment to Hep B vaccination in China. In 2002 the Chinese national government added hepatitis B to all routine childhood immunizations (known as EPI vaccines). Then, in March 2005, it passed a new regulation stating that all EPI vaccines be given at no cost to parents. The ministry of health also designated hepatitis B as one of four high priority diseases for national control and developed a national hepatitis B control plan for 2006-2010, with the goal of reducing to less than one percent the proportion of children under the age of five who are carriers of the hepatitis B surface antigen. The Chinese vaccine industry, which has produced Hep B vaccines since the 1980s and had a licensed vaccine since 1990, was also prepared to scale up. The GAVI-supported project used this vaccine, purchased through a national bid and tender process with international observers. Success has also been bolstered by China's Safe Motherhood Initiative, which urges mothers to give birth in hospitals. In addition, unprecedented cooperation between grassroots vaccination staff and child and maternal health staff in hospitals has fostered the approach of â€œwhoever delivers the infant should give the immunization.â€? As a result, today more than 90 percent of the babies in the project area hospitals receive their birth dose of hepatitis B vaccine on time-within 24 hours of delivery. The biggest challenges remain reaching babies born at home in the most remote rural areas. Efforts to scale-up immunization there include increased coordination between village doctors, vaccinators, midwives and mothers, as well as regular vaccine deliveries to remote areas. ]]> <![CDATA[A Cause for Concern]]> https://biospectrumindia.com/news/95/3013/a-cause-for-concern.html https://biospectrumindia.com/news/95/3013/a-cause-for-concern.html Thu, 09 Nov 2006 15:02:00 +0530 Hepatitis B vaccine in National Immunization Program Hepatitis B vaccine in National Immunization Program A Cause for Concern Four years after the launch of a pilot project for the introduction of Hepatitis B vaccine in the National Immunization Program in 2002, medical professionals have expressed concern over the inclusion of Hepatitis B due to lack of sufficient data and also the high cost outlay (Rs 500 crore each year) for universal immunization with Hepatitis B vaccine in India. The government of India launched a pilot project for the introduction of hepatitis-B vaccine in the National Immunization Program on June10, 2002. Under this project, hepatitis B vaccine is administered to infants along with the primary doses of DPT vaccine in the 6th, 10th and 14th week. The project is presently being implemented in 33 districts and 15 metropolitan cities. Soon the hepatitis B vaccination program is to be expanded to cover 11 states across the country. To begin with, monovalent hepatitis B vaccine has been used. Depending on the availability and cost of a combination vaccine, the government will evaluate and shift to the combo vaccine in future immunization programs. The vaccine and syringes are being made available by Global Alliance for Vaccine and Immunization (GAVI). Expenditure for IEC, training and monitoring budget is being incurred through the domestic funds. India received assistance to the tune of $ 4.1 million for a period of two years from the Global Alliance for Vaccines and Immunization (GAVI) and the Vaccine Fund, based on an application from the Indian government and partners. The funds have been awarded to support the introduction of the hepatitis B vaccine into India's immunization program, which does not currently include the vaccine hepatitis B is a significant public health concern in India. It is estimated that 60 percent of liver diseases are due to hepatitis B infection and 80 percent of liver cancer cases in India are due to hepatitis B. The challenge of hepatitis B, like AIDS, is that it is "hidden" and its debilitating impact takes a long time to emerge. The difference is that there is an effective vaccine for hepatitis B, according to GAVI. The project launched by the then prime minister, Atal Behari Vajpayee in 2002 is to be expanded in a phased manner during the Tenth Five-Year Plan, so that hepatitis B vaccination can be integrated into the routine immunization services and strengthens them. The implementation of the hepatitis B vaccination project has started in 14 cities. The city of Patna has completed the hepatitis B training for medical officers and vaccinators but vaccination has not started due to preoccupation with Pulse Polio Eradication Program. Overall, the coverage of infants in all cities as in 2004 is about 98 percent (44,8,388 children vaccinated for third dose of hepatitis B against target of 4,55,688). Overall, the coverage of infants in all districts as in 2004 is about 76 percent (7,68,251 children vaccinated for third dose of hepatitis B against target of 1,001,484). Concerns from medical professionals The government has to have an outlay of Rs 500 crore per year for the implementation of immunization program of Hepatitis B vaccine. However, issues related to introducing Hepatitis B immunization has been a cause for concern among medical professionals in the country. The national president of the Indian Medical Association (IMA) (2005-2006), Dr Sudipto Roy set up a sub-committee under the chairmanship of Prof SK Mittal with Dr Dharam Prakash as convenor, to look into the issues concerned with the following objectives: to assess the prevalence of Hepatitis B in the country, and collect available data on deaths from hepatocellular carcinoma, to evaluate what the immunization program will cost the country, to look for evidence of the success of the pilot project, and to collect evidence from worldwide literature on the results of Hepatitis-B vaccination starting in the sixth week. The committee first met on October 19, 2005. It was decided to hold a national-level consultation on May 14, 2006 to discuss the issues related to Hepatitis B immunization. Dr Jacob Puliyel, co-chairman, sub-committee prepared a draft position paper on Hepatitis B. A national consultation of experts was held on May 14, 2006, which was co-sponsored by Plan International (India). After discussions, the experts arrived at the following conclusions and made some recommendations on Hepatitis B vaccination in India. Conclusion 1: On meta-analysis, the true prevalence of Hepatitis B in India among non-tribals is 2.1 percent (95 percent CI 1.8-2.5). This is the meta analysis of the data of point prevalence, not carrier rate. It was pointed out that chronic carriers have to be positive on repeat testing in two tests at least six months apart. The carrier rate is approximately 80 percent of the point prevalence rate. This corresponds to a chronic carrier rate of 1.6 percent. Conclusion 2: Hepatocellular carcinoma constitutes only 1.6 percent of all cancers in India, hence is very rare. However, it is not clear how many of these are related to Hepatitis B. The estimated annual deaths attributable to hepatocellular carcinoma due to hepatitis B are only 5,000. A better marker of burden of Hepatitis B may be obtained by a registry counting cases of cirrhosis as about a third of cases of cirrhosis in adults is related to Hepatitis B. Reliable data on this is not available. Recommendation: In view of these estimates, the cost efficacy of universal immunization with Hepatitis B needs to be re-evaluated. Conclusion 3: Vertical transmission of infection from mother to child is an important mode of acquiring Hepatitis-B infection, especially in establishing chronic Hepatitis B carriers. The exact incidence of vertical transmission is not known in our country but it may be contributing between 30 and 40 percent of the pool of chronic Hepatitis B carriers. Recommendation: Before launching any national program, it would be vital to assess the contribution of vertical transmission to the overall Hepatitis B carrier pool. If universal Hepatitis-B vaccination is to be carried out, the currently available data, though inadequate, would strongly favor initiation of Hepatitis B vaccination starting at birth, to derive maximum benefit from the program. Conclusion 4: There is no scientific data from anywhere in the world that the schedule of 6, 10 and 14 weeks has been found to be effective in reducing the carrier rates of Hepatitis B. The pilot project carried out in Andhra Pradesh and Delhi with 6, 10 and 14 weeks has not been evaluated for its efficacy. We need to know the effect on carrier rates among the children who received the vaccine in the 6th, 10th and 14th weeks compared to the unvaccinated children. Recommendation: It will not be advisable to initiate a national/ sub-national immunization program without proper evaluation of the pilot project. Conclusion 5: The overall prevalence of chronic carrier rate among the tribal population is very high (19.4 percent (95 percent CI 15.3 â€“ 23.5) which is comparable to those living in the East Asian countries. Recommendation: A well-designed epidemiological study is needed in this population to study the natural history of the disease. If necessary, a vaccination program, with first dose being given at birth, could be considered in these population groups.   ]]> <![CDATA[Monsanto's Transgenic Cross]]> https://biospectrumindia.com/news/95/1317/monsantos-transgenic-cross.html https://biospectrumindia.com/news/95/1317/monsantos-transgenic-cross.html Fri, 20 Oct 2006 10:56:00 +0530 Monsanto Monsanto's Transgenic Cross India's Supreme Court has put a temporary halt to the march of transgenic crops in the country. In an interim order while hearing a public interest litigation(PIL) in late September, the Court has asked the regulator to put on hold all future approvals of genetically modified (GM) products till it gives a final order. The saving grace, however, has been that the Court has asked the regulator to continue the ongoing field trials of various GM products approved earlier. The strong anti-GM organizations which had filed the PIL are ecstatic that they got at least a partial victory. The BioAgri companies are disappointed but also happy that all existing approvals will stay till the final orders. The Court order has come as a surprise. Because in recent months India's top policy makers, including the Prime Minister, Minister for Agriculture, Minister for Science & Technology, have come out in full support of using more biotech in agriculture. And they have all highlighted the long list of GM products under development in private and public institutions in the country. Yet, a few committed anti-GM activists like Suman Sahai, Devinder Sharma, Vandana Shiva and Aruna Rodriguez and of course, Greenpeace, have dictated the agenda of the public discourse on GM products. Why has this happened? The BioAgri industry is yet to gather its wits on this issue and speak out collectively on this issue, even a week after the order. Barring a few agricultural scientists, the community of agriculture researchers have yet to come out in the public with their impartial views. Monsanto, whose subsidiary, Mahyco-Monsanto which is the principal player in the country's Bt cotton market too has not covered itself with glory. There is a strong feeling within the industry that Monsanto has preferred to let others bat for GM products and not come out fully to engage the public and opinion making sections of the Indian society. Monsanto has so far relied on the technological superiority of its products and refrained from carrying the various stakeholders of the industry with it. According to BioSpectrum estimates, Monsanto may have earned about Rs 800 crore in technology license fee from its Bt cotton seeds since its commercial introduction in March 2002 to September 2006. However, when anti-GM activists claim that Monsanto has earned over Rs 4,000 crore from technology fee, which is just one-fifth of the actual amount, these allegations strike a chord in the public and remains unchallenged. The industry has come together to discuss many such issues confronting it, during the BioSpectrum CEO Summit series in August-September. Dr M K Bhan, Dr R A Mashelkar and Dr Cyrus Poonwalla, ably assisted by Dr Rashmi Barbhaiya, Mr Nitin Deshmukh and Mr Hari Bhartia, helped the industry leaders to focus on the tasks ahead. Attended by nearly 200 industry leaders in Bangalore, Mumbai and New Delhi, the BioSpectrum event has prepared the blueprint for the next phase of the growth of the industry. There is a role for every one to play- government, biotech industry, researchers and students- agreed the CEOs. It's not that the industry and the government do not know what the issues are, but the challenge is taking the process of dialogue further forward. Though several things have changed in the past few years, the process of change is not commensurate with the changing dynamics of the industry. It is time for some radical thinking and action to bring about the desired changes in a much lesser time frame, for a more meaningful purpose and with a greater share of accountability. The snapshots of the discussions and suggestions are available in the following pages in an easy-to-read format. Many of the participants wanted the dialogue to continue on some other segments too. BioSpectrum would continue these efforts and of course, looks forward to generous support from the industry to make these happen more frequently. <sureshn@cybermedia.co.in> ]]> <![CDATA[Analytical instruments business in India on the rise]]> https://biospectrumindia.com/news/95/2177/analytical-instruments-business-in-india-on-the-rise.html https://biospectrumindia.com/news/95/2177/analytical-instruments-business-in-india-on-the-rise.html Wed, 18 Oct 2006 15:37:00 +0530 Analytical instruments business in India on the rise Analytical instruments business in India on the rise India is considered as one of the most important growth markets for analysis, laboratory-technology, diagnostics and biotechnology solutions in Asia. The most important sectors driving the growth in the Indian market include biotechnology, bioinformatics, contract research, diagnostics, pharmaceuticals and healthcare and the food industry. India is trying hard to combine the strengths of its software industry with modern biotechnology in order to compete in the market for bioinformatics, and it is aiming for a five percent share of the overall global market. The Indian commercial sector also sees lucrative growth opportunities when it comes to research and development services for internationally active corporations in the pharmaceutical and medical sectors as well as in the consumer-goods industry. According to the Confederation of Indian Industry (CII), 400 laboratory enterprises in India are specialized in research and development services for biotechnology and the life sciences alone. The pharmaceutical and food industries also continue to grow. The one thing that all of these branches of industry have in common is that they generate a great deal of demand for high-tech analysis, state-of-the-art laboratory technology and innovative diagnostic solutions. "The growth in biotechnology, bioinformatics, contract research, diagnostics, pharmaceuticals and healthcare and the food industry, modernization of universities and institutes are driving the growth of analytical instruments market in India," said Nitin Kabbin, managing director, Dionex India Pvt Ltd. The overall analytical and diagnostic products and laboratory equipment market in India has been on the rise since 1998 from â‚¬ 593.17 million (about Rs 3,558 crore) and reached â‚¬ 976.54 million euros (Rs 5,856 crore) in 2003-04 (according to M+V market development services). And India is an important destination. KV Venugopalan, president, Waters India, pointed out, "The worldwide market for analytical technology in 2005 was $31 billion and this is estimated to grow to $41 billion by 2010. While North America accounts for the largest share of the pie with 38 percent share, Europe accounts for 31 percent share. The Asia-Pacific region accounted for close to 22 percent of the share in 2005. In terms of growth forecast by technology, life science instrumentation, separations and surface sciences are the three big areas. The life science instrumentation alone accounted for 26 percent share of the $31 billion figure. The life sciences instrumentation market was estimated at $8 billion. Separations is the next dominant technology with $5 billion in revenues. Surface science's share was $3.8 billion." "Though the analytical and diagnostic products and laboratory equipment market in India is growing at rate of 20 percent, about 60-70 percent of the demand is met through imports," said Nitin Kabbin. Agreeing to the fact that the Indian analytical instruments market is growing at 20-25 percent, Rajendra Barabde, director, Chromline Equipment (I) Pvt Ltd said, "Most of the biotech projects are still on papers. It will take another two-three years to see more activities in biotechnology in the country. Government has taken a lot of initiatives to promote biotechnology across the country and also sponsored many projects." Rakesh Kumar Gupta, regional sales manager, IDEX Asia Pacific Group said, "The growth of biotechnology industry is one of the driving factors for the growth of analytical instruments market in India. The demand is more for the High Performance Liquid Chromatography, Liquid and Gas Chromatography, Mass Spectrometers." And more than 60 percent of all these high tech equipment and solutions still are imported. German manufacturers alone exported analysis equipment and laboratory technology products worth 68 million Euros (approximately Rs 408 crore) to India last year, registering an increase of nearly 27 percent over 2004. In addition to Germany, major companies from other countries like the US, Japan, France, and Sweden are present in India. Agilent Technologies, Alfa Laval, Bio-Rad Labs, Dionex, GE Healthcare, Millipore, Pall, PerkinElmer, Sartorius, Shimadzu, Thermo Electron Corporation, and Waters are a few examples. These companies have full fledged set-ups in India providing the necessary support and services to the Indian companies. Although local manufacturers are coming with quality products, they are not yet in a position to meet the requirements and international standards when it comes to high-end equipment like chromatography, HPLCs, and mass spectrometry. Nitin Kabbin observed, "There are many Indian players who are indigenously manufacturing analytical instruments. But a lot more is to be done on the design and development. It can be done by the motivated and dedicated entrepreneurs with a good support from the government." Narayan Kulkarni with Ch. Srinivas   ]]> <![CDATA["European and US expectations differ in validation of sterilization process"]]> https://biospectrumindia.com/news/95/1866/european-and-us-expectations-differ-in-validation-of-sterilization-process.html https://biospectrumindia.com/news/95/1866/european-and-us-expectations-differ-in-validation-of-sterilization-process.html Wed, 18 Oct 2006 15:31:00 +0530 New Page 1 "European and US expectations differ in validation of sterilization process" -James Agalloco, president of Agalloco & Associates James Agalloco has assisted more than 100 pharmaceutical, biotechnology, medical device, equipment manufacturers and bulk pharmaceutical firms in a range of validation, automation and compliance areas in the last 15 years. Jim, a past president of the Parenteral Drug Association, has over 33 years of industrial experience. He has served as chairman and member of numerous PDA committees and remains active on several committees. He was in India to share his perspective on sterilization processes and systems validation. What are the key areas companies should look at when talking about validation of sterilization process systems? I think the key areas that we have to address are the European and US expectations that differ from each other somewhat dramatically. In the EU, there is a great deal of emphasis on physical measurements and the requirements are very well defined. In US FDA, you have much broader perspective and the focus is more on microbiological issues and physical directives are much less important. There are many prescriptive requirements you find in Europe. As noted earlier, the regulators in the US require microbiological data. Sterilization is mainly to kill harmful microorganisms, which according to me, is core and that is what the sterilization process is all about. In the European sense, it is much more related to physical data and have a greater number of constraints on temperature measurements, pressure measurements and other measurements that we get from instrumentation as a proof of vital efficacy. There is a disconnect. So the emphasis should be on what we emphasize and how to approach. How will it effect the Indian companies as most of them export their range of products to European countries as well as to the US? It has its effect on everyone. In a global sense, you try to comply with differing expectations with different emphasis. You don't want to make different things, for the same purpose and the same thing in different ways, with different modules, in terms of lot of products and documentations. The documentation packages have to be addressed. For different needs, you don't want to prepare two reports, for the same thing. Is the US FDA looking at streamlining this process for the benefit of the industry? There is an idea going on for harmonization of the entire process. The one area, which has not been harmonized so far, is sterilization process systems. There is a little consensus on what we have to do on sterilization process. The European and US regulations are different. Further there is a major gap between what the firms do and what the inspectors require. We have different views on the same thing. Is there any agency active in harmonizing the processes related to sterilization systems? In the real sense, there is no organization or agency, which is actively working for harmonization of the entire process. The real harmonization should come from the industry. The industry should become the leader and rest will become followers. The harmonization will come out by doing more, rather than by doing what is correct. Harmonization is not what is acceptable to one or the other but it is doing things in an acceptable manner for all. At present, we don't see that. Where do Indian companies stand as far as validation of sterilization process is concerned? I don't think they lack much in any of areas at this point in time. I am quite impressed with the companies that I have interacted with. Certainly they know and are aware of the expectations and requirements of the regulatory agencies from the European Union and US FDA. However, it is hard to say where they are. Even the American companies do not know where they are. The game is harder to play every year. These products are critical. The FDA is changing the focus to these products and also raising the bar all the time. I feel Indian companies already have world-class facilities and are having the tougher job of meeting requirements of both the EU and the US. What are your suggestions for Indian companies that are looking at both the markets (the European Union and the US)? Simplify. Do things in a common way as much as possible. Take advantage of what is agreeable in common ground and participate as much as possible in shaping up issues on harmonization.   ]]> <![CDATA[Senate panel okays legislation to restore Grant Eligibility for SMEs]]> https://biospectrumindia.com/news/95/2402/senate-panel-okays-legislation-to-restore-grant-eligibility-for-smes.html https://biospectrumindia.com/news/95/2402/senate-panel-okays-legislation-to-restore-grant-eligibility-for-smes.html Wed, 18 Oct 2006 15:29:00 +0530 Senate panel okays legislation to restore Grant Eligibility for SMEs Senate panel okays legislation to restore Grant Eligibility for SMEs The US Senate committee on Small Business and Entrepreneurship has given its consent for the legislation to restore Small Business Innovation Research (SBIR) grant eligibility to small biotech companies that are majority backed by private investment. Praising members of the Senate Small Business and Entrepreneurship Committee for supporting legislation, Jim Greenwood, president and CEO of the Biotechnology Industry Organization (BIO), said "This amendment restores the original interpretation of eligibility by allowing more biotech and medical device companies to again compete for funding albeit limited to conduct research on innovative new medical therapies, providing promise and hope for millions of patients and their families. He further said, "For more than 20 years, small biotech and medical device companies qualified for SBIR grants. The arbitrary 2003 change in eligibility standards inequitably penalized biotech firms and has delayed, in some cases even prevented, life saving drugs and life-enhancing medical innovations from reaching patients and consumers. "Presently, companies that are 51 percent owned by a group of venture capital firms are not eligible for SBIR grants. Most small and emerging biotechnology companies, which are years away from revenue-generating products, must look to the venture capital community for investments to fund the very high-cost pre-clinical and clinical research. Prior to the new interpretation, these companies used SBIR grants to validate the potential of their research as they raised critical start-up investment funds. According to Biotechnology Industry Organization, over 325 million patients have been helped by one or more of the 200 biotech drugs and vaccines already in the market. Source: www.bio.org   Senate passes Stem Cell Research Enhancement Act The US Senate has passed HR 810, the Stem Cell Research Enhancement Act, by a vote of 63-37. This Act would expand the limited number of stem cell lines currently available for federally funded research. The US House of Representatives passed HR 810 by a vote of 238-194 on May 24, 2005. HR 810 would expand the limited number of stem cell lines currently available for federally funded research by allowing individuals to donate excess embryos from in vitro fertilization clinics which would otherwise be discarded as medical waste. Individuals who choose to donate these excess embryos would have to give written consent and would not receive any monetary compensation for the donation. Reacting to passage of the Act, Jim Greenwood, president and CEO of the Biotechnology Industry Organization (BIO), said, "The bipartisan passage of the Stem Cell Research Enhancement Act by both the House and Senate reflects the strong support of the vast majority of Americans for this very promising research." He further noted, "While embryonic stem cell research is still at an early stage, the nation's top scientists agree that this technology has the greatest potential to provide new, groundbreaking therapies for diabetes, heart disease, spinal cord injuries and a host of other disabling and deadly conditions. We must do all we can to accelerate the research and explore all avenues of therapeutic possibilities to their fullest. This bill allows important research to advance and creates an ethical framework that will ensure it is done appropriately." Source: www.bio.org ]]> <![CDATA["SA is the only country in Africa to commercialize Bt products"]]> https://biospectrumindia.com/news/95/1088/sa-is-the-only-country-in-africa-to-commercialize-bt-products.html https://biospectrumindia.com/news/95/1088/sa-is-the-only-country-in-africa-to-commercialize-bt-products.html Wed, 18 Oct 2006 15:24:00 +0530 New Page 1 "SA is the only country in Africa to commercialize Bt products" -Dr Idah Sithole-Niang, PBS-Regional Coordinator for Southern Africa The Program for Biosafety Systems (PBS) is supported by the United States Agency for International Development (USAID) to assist developing countries to enhance biosafety policy, research, and capacity. The PBS is run by a consortium of professionals and institutions with a high level of knowledge in biosafety program and policy development in developing countries. In a chat with BioSpectrum, Dr Idah Sithole-Niang elaborates on the strides made by the South African region in the biotech arena. What is the status of modern biotechnology in South Africa? How successful are the modern biotech crops? In South Africa, GM research started in 1982, and over 500 field trials have been conducted so far. Till date the country has commercialized five GM products-Bt cotton, Bt maize, Bt yellow and white maize, herbicide tolerant round up ready soyabean, and the latest in the series is round up ready bollgard. The round up ready bollgard, which has the stacked genes for resistance in cotton, was approved last year. All these products have been developed by large multinational companies in the US and now there are hybrid varieties with these traits locally available in the South African market. The country has developed biotechnology research innovation centers and research platforms, which are new efforts to coordinate biosafety to support biotech R&D. What are the issues and challenges facing the spread of biotechnology in the African region? Some of the important concerns in the region include: South Africa is the only country out of 53 countries in Africa to commercialize Bt products. Egypt has had four products ready since 2002, but there is perceived market pressure which persists. Time taken for commercialization is long and costs are high due to biosafety regulatory requirements. In the South African region, there is ambivalence towards genetically modified products, while the food security is still threatened. There is a need for creating awareness about biotechnology to the public, policy and decision-makers. There is a need for building national strategies, fostering sub-regional cooperation and public-private sector partnerships. In addition, there is a requirement for developing policies to guide and create an enabling environment for regulatory, institutional, legal and technology transfer issues. Capacity building and infrastructure; brain-drain, mobility and gain; limited funding and GM research on orphan crops are some of the other important challenges. From a policy perspective, how are the countries equipped to handle modern biotechnology in the African region? Of the 41 African countries, 29 have signed the Cartagena Protocol, while 24 have ratified it. The current status of biotechnology legislation in the region is as follows: In Namibia there is a biotechnology policy and they are finalizing their National Biosafety Framework. Along with Namibia, Cameroon, Kenya and Uganda are in the implementation phase as part of a group of eight countries worldwide. Zambia has a biotech strategy and it is now looking at a legal framework to implement. Zimbabwe and South Africa already have laws and are implementing them. Simultaneously both these countries are reviewing the existing biosafety frameworks. Malawi and Mauritius have the required legislation, although Malawi is now reviewing the Biosafety Act and developing a Biotech Policy. Lesotho is finalizing the draft policy and bill; the bill at Swaziland is in development; Moza through GIIBS are finalizing their draft bill. Tanzania has a draft interim biosafety framework. It is now finalizing its draft and getting ready for Bt cotton trials. Botswana has a Draft Biosafety Bill, which it is fine tuning and the case of Mozambique is also similar. How is your organization facilitating the Program for Biosafety Systems (PBS)? The Program for Biosafety Systems (PBS) is global. It is a consortium of biosafety experts and in Asia we work in Indonesia and the Philippines, while in Africa we work in three regions-West Africa, East Africa and the Southern Africa. In Southern Africa, the PBS is in Malawi assisting in fine-tuning their regulations and the policy development. We are at present assisting conduct of confined field trials for transgenic cassava resistant to African cassava mosaic virus. This component within PBS is run out of the International Food Policy Research Institute (IFPRI) in Washington and is funded by the USAID. The PBS has other components like the BBI-Biotechnology Biodiversity Interface, which is a competitive grant program that will run every year in the whole of Africa, Indonesia and the Philippines for risk assessment research. Concurrent to that, there is a component on biosafety/food safety training in which the Michigan State University, US is assisting. The university helps in training both in Asia and Africa. There is another component on the regulatory approval strategies. Rolly Dureha ]]> <![CDATA[Supreme Court says "no" to more transgenic crops]]> https://biospectrumindia.com/news/95/6861/supreme-court-says-no-to-more-transgenic-crops.html https://biospectrumindia.com/news/95/6861/supreme-court-says-no-to-more-transgenic-crops.html Wed, 18 Oct 2006 15:22:00 +0530 Supreme Court says Supreme Court says "no" to more transgenic crops Orders GEAC to keep approvals on hold. The Supreme Court of India (SCI) on September 22, 2006) directed the Genetic Engineering Approval Committee (GEAC) not to give approvals to genetically modified products until further orders. "This has perplexed the biotech community but exhilarated the anti-biotech lobby, which seems to read too much in this two-week restriction," said Prof. C Kameswara Rao, executive secretary, Foundation for Biotechnology Awareness and Education, Bangalore. The Supreme Court's directive was in consideration of a Public Interest Writ Petition (PIL) filed on May 1, 2006 in the matter of Aruna Rodrigues and Others regarding the Biosafety of Genetically Modified Organisms (GMOs), which are allowed to be released into the environment. The petition sought for issue of directions to stop all field trials for all genetically modified products anywhere and everywhere with immediate effect, besides certain other considerations. The Supreme Court's interim order stated that "we are not inclined to direct stoppage of all field trials at this stage without (considering) the stand of the respondents. At the same time, we deem it appropriate to direct GEAC to withhold the approvals till further directions are issued on hearing all the concerned". The next hearing on the Writ petition has been fixed for October 13, 2006. The Supreme Court's order would not apply to field trials of GM products, which were already approved by the GEAC. The Supreme Court also stated that the Government would also consider associating independent experts in GEAC. "The petitioners may give their suggestions to the learned counsel for the respondents in this regard within a period of one week from September 22." "The advice of the Court to the Government to 'consider associating independent experts in the field with the GEAC' is not an issue with the GEAC, as they had earlier involved other outside experts. The anti-tech activists too were given an opportunity to present their point of view before the GEAC," said Prof. Kameswara Rao. The next hearing of the Supreme Court is on October 13. The PIL and the key concerns The writ petition was filed in public interest by Aruna Rodrigues, an economist and marketing management consultant; Dr Devinder Sharma, a trained agricultural scientist and writer; PV Sateesh, cofounder and general secretary of the Deccan Development Society; and Rajeev Baruah, a management specialist and managing director, Maikaal bioRe. The petitioners pleaded for a stay against grant of fresh approvals and of all field trials on genetically modified crops, as they were concerned with the absence of proper scientific examination of Biosafety aspects. Dr Devinder Sharma, one of the petitioners, told BioSpectrum, "We are seeking a moratorium on GM crops as their biosafety aspects and their implications are not clear. The GEAC is just a rubber stamp for the industry. It kept on approving the Bt cotton varieties, while the cotton farmers were committing suicides. The past four GEAC heads should be held accountable for the current cotton crisis. How could they approve new Bt cotton varieties, while the cotton farmers were dying? Now that all claims of the Bt cotton seed suppliers have turned wrong why are they not being put behind bars? This is after all not a collateral damage but loss of human life which is a crime. Hence we have requested the Supreme Court to put clamp on the GEAC till there is clarity on the issue." "Currently, we are facing a terrible agricultural crisis. While at one end the farmers are committing suicides, on the other, the corporates are pushing the Bt technology. During the cotton crop season, from 2002 to 2005, Monsanto had earned a royalty (technology fee) of Rs 1,400 crore. And in 2006, their earnings are to the tune of Rs 4,000 crore. How can they justify such earnings when the farmers are continuously incurring losses? On its part, GEAC sat on all the crop failure results and kept on pushing newer varieties for approval. Until we are clear about the technology, it should not be pushed especially at the cost of the farmers' lives," added Sharma. The charges made by Dr Sharma are very strong. But according to the ISAAA spokesperson in India, under the Environment Protection Act there are bodies which have been assigned different functions involved in the GM crop trials. "All the activities and the bodies responsible for them are clearly defined. For example, the Institutional Biosafety Committee (IBSC) looks into whether the project has been properly established, etc; the Review Committee on Genetic Manipulation (RCGM) monitors the safety related aspects of the projects, while the Genetic Engineering Approval Committee (GEAC) looks into the environmental safety aspect and is responsible for the approval of proposals relating to the release of genetically modified crops. Since the past three-four months, all the large scale trials have been approved by the GEAC with the inputs of the RCGM as per the directive of the Supreme Court." "The fact is that there is a well-appreciated and robust multi-step mechanism for biosecurity evaluation of genetically engineered (GE) crops in the country," informed Prof. Kameswara Rao. Dr KC Bansal, Principal Scientist, National Research Centre on Plant Biotechnology, IARI, added, "All the crop varieties are released after extensive scientific testing and validation. We have an extremely rigorous biosafety mechanism in the nation, which we follow for every crop that is made available to the farmers." Another concern that the Petitioners have raised in their writ petition is that the "use of technology of genetic engineering and release of GM organisms into the environment would require application of precautionary principle, which mandated that every possible precaution must be taken to ensure that no harmful effects are caused to human and animal health and environment due to the use of new and unknown technologies and organisms". Prof. Kameswara Rao believes this is overstretching the import of the Precautionary Principle, which advises only a cautious approach, and was not intended to block deployment of GE products altogether on objections not supported by science. "Precautionary Principle was also not meant to be invoked ad infinitum and ad nauseam," said Rao. Further, the Petitioners state that GE, if allowed to proceed unchecked, would irrevocably change the molecular structure of the world's food supply and impact the biodiversity through unrecallable, self replicating organisms. The reason for this according to the petitioners is that "scientists do not understand the mechanisms of GE-induced changes in gene expression in sufficient detail and they do not know what to look for and these things are termed 'unintended effects'. And one of the most insidious 'unintended' effects of GE is Horizontal Gene Transfer (HGT) and this concern makes the technology of GE highly unpredictable and also extremely dangerous and puts in doubt the safety of GE process itself." This is a highly imaginative and misleading assumption to paint a scary scenario, which does not make any scientific sense, says Prof. Kameswara Rao. "The GEAC is composed of competent experienced agricultural scientists and other experts who know their responsibility and they have been doing their job as per the rule of law. What might have disturbed the anti-agribiotech lobby in India is that the present GEAC is more pro-active and does not dilly-dally, like its predecessor," added Prof. Rao. The petition also has other charges that GM companies are sabotaging regulatory regimes of third world countries, including bribing of government officials to get clearances; that the Indian farmers and consumers do not have the choice to better farming prospects and livelihood; that open field trials of Bt Okra, Bt Brinjal and Bt Rice are being conducted in various parts of the country on the basis of the safety tests conducted by the companies and without any independent verification of their safety claims about GM seeds. Several people in the industry argue that the farmers chose what was best for them and discarded thousands of varieties of crops that were in cultivation at the given time. The farmer will continue to exercise a similar choice and if there were no demand for GE varieties, the market forces will push them out. "Further the Indian public sector institutions have developed about 39 GE traits in 23 crops, much more than the private companies," said Rao. Throughout the world, the product developers provide the basic biosecurity data based on existing governmental guidelines. They are verified and supplemented by public institutions and/or accredited private establishments. In India there are no independent private institutions to conduct biosecurity evaluations. The Department of Biotechnology (DBT), Government of India, is now in the process of putting such a mechanism in place. Currently, the independent public sector research institutions of the Indian Council of Agricultural Research (ICAR) conduct biosecurity evaluations. While everyone will eagerly wait for the Supreme Court's decision, no one in the industry is denying the concerns of biosafety, but they believe that GM technology should not be rooted out. The evaluation should be on the basis of scientific evidence. Ch. Srinivas Rao with Rolly Dureha   ]]> <![CDATA[Marine biotech sector needs a shot in the arm]]> https://biospectrumindia.com/news/95/3080/marine-biotech-sector-needs-a-shot-in-the-arm.html https://biospectrumindia.com/news/95/3080/marine-biotech-sector-needs-a-shot-in-the-arm.html Wed, 18 Oct 2006 15:20:00 +0530 Marine biotech sector needs a shot in the arm Marine biotech sector needs a shot in the arm The applications of marine biotechnology are enormous and varied. With government backing, a lot of research activities have been going on in India, but the sector is yet to capture the attention of entrepreneurs. Biotechnology has played a key role in the economic growth of India, with its contribution mainly in the biopharmaceuticals and agriculture space. But still there are many areas like herbal medicine, biofuel and marine biotech where India needs to focus. Nevertheless the interest level in the marine sector among researchers has been increasing mainly because of its applications in various industries. Marine biotechnology is about the discovery and development of marine resources (like marine organisms) into a wide range of new products, e.g. food, food additives, healthcare, cosmetics, pharmaceuticals and medical applications. These organisms have been in the spotlight owing to their unique features, which part them from the rest of the terrestrial biodiversity. These organisms have been found to possess characteristics like alkalinity tolerance, thermo tolerance, baro tolerance and the ability to use unusual molecules. These attributes make marine organisms a useful resource for use in different industries, bioremediation and agriculture. Anasuya Lahiry, sector specialist, marine and environment (Class I), Gujarat State Biotechnology Mission, Department of Science & Technology, Government of Gujarat, said, "Many marine plants and animals stay anchored to the seabed and produce toxins to ward off preys like fishes. These toxins have been shown to be promising cures against many diseases. Also, many molecules found in marine organisms have totally different patterns of construction from the molecules of medicinal value found in terrestrial plants and animals." "More than 12,000 novel chemicals from marine plants, animals, and microbes are being worked on and a large number of pharmaceutical products, enzymes and biomaterials have been developed. Many marine organisms can be used in bioremediation, owing to their ability to produce antifouling agents which help ward off predators. These compounds with minor or no modification can serve as effective yet non-environment polluting antifouling agent." Referring to marine biotechnology as "Blue Biotechnology", Dr Shanta Achuthankutty of the National Institute of Oceanography, Goa, said, "Marine biotechnology is the use of marine biological systems or its derivatives to make or modify products or processes for use in food science, medicine and environment. The uniqueness lies in the fact that the marine environment constitutes a major share of the Earth's biological resources and organisms often possess unique structures, metabolic pathways, reproductive systems, and sensory and defense mechanisms. Traditional marine biotechnology has been in use for removing cuttlefish toxins, cleaning wounds with seawater and in other applications." With the development of molecular biology and advancement of instruments, marine biotechnology has been given a new perspective. Laborious and imperfect tools of marine microbiology such as culturing are being refined or replaced by the 21st century tools such as genomics and computational analysis. Evolutionary advances across science, notably the acceleration of progress in such fields as information technology and nanotechnology, coupled with the breathtaking progress in microbiology itself, has positioned marine biotechnology to enter a new realm of discovery. Yet the potential of this domain as the basis for new biotechnologies remains largely unexplored in India. Prof. Bhavanath Jha, head, department of marine algae and marine environment discipline, Central Salt & Marine Chemicals Research Institute, Bhavnagar, said, "Marine biotechnology is an emerging thrust area of biotechnology, which harnesses the enormous but uncharted gene pool and functional diversity of marine life towards finding new genes, organisms, biosensors, natural products and unusual biochemical processes of importance to agriculture, industry, nutrition, medicine and the environment." Market Globally, the marine biotechnology market is projected to exceed $3.2 billion by 2007 with the non-U S segment comprising the bulk of the market. This non-US segment comprises some of the Asian, Australian, African and European countries. Also, parts of North and South America would be amongst the major contributors. Indian coasts that extend to about 5,700 km on mainland and to about 7,500 km including two groups of islands (Lakshadweep and Andaman & Nicobar) have rich diversity of corals, fishes, important arthropods and molluscs. The Western coastline (covers states such as Gujarat, Karnataka, Maharashtra, Kerala and Goa) has a wide continental shelf having an area of about 0.31 million km, which is marked by backwaters and mud flats. The East coast consists of Tamil Nadu, Pondicherry, Andhra Pradesh, Orissa and West Bengal, which is flat and deltaic and rich in mangrove forests covering an area of about 1,430 km. Asia's largest brackish water lake Chilka, Andaman & Nicobar islands, Lakshadweep, Gulf of Kachchh and Khambat and Gulf of Mannar are also important for biodiversity studies. Sharing his knowledge about the sector, Dr T Charles John Bhaskar, scientist and managing director, GeoMarine Biotechnologies Research & Educational Institute, Chennai, said, "At present the marine biotech segment in India is a minor one. However, in my opinion in about five years, it should account for around 20 to 25 percent share in the total biotech industry. Marine biotechnology will play a major role in various sectors such as biopharma, bioagri, bioindustries and bioenergy." He continued, "Marine biotechnology is gearing up globally too. About 10,000 compounds are known from marine sources. Already many compounds are in the final testing stage for antiviral, anticancer, antihypertensive and anti parkinsonian activity. Many industrial enzymes could be obtained from marine organisms. In fact they can be much superior compared to those from terrestrial source. Vibrio alginolyticus, a marine bacterium produces a detergent resistant protease that can find application in detergent industries. What is interesting is since the bacterium lives in high salt concentration, the enzyme will act in low water activity situation such as those encountered in industries where organic solvents are used. For the same reason many halophilic bacteria can work better in bioremediation and effluent treatment." Although biotechnological research has progressed in the marine sector, the industrial base in India, for marine biotech lead industries are markedly less. The key ones in this space includes Cellgen Biologicals, Samudra Biopharma, GeoMarine Biotechnologies, Nurture Aqua Technology and ABL Biotechnologies. The companies operating purely in marine biotechnology are few. Since aquaculture and marine byproducts are also considered as marine biotechnology, there should be about 100 companies operating in this space. This figure does not include shrimp and fish hatcheries and marine food exporters. In the absence of split-up on marine biotechnology products and other products, it is difficult to determine the leader. ABL Biotechnologies, Mangalore Biotech and Parry Nutraceuticals are a few leading names. Research activities India has been working on drugs from the sea (bioactive compounds from mussels, sponges and microorganisms), enzymes that are salt and alkaline tolerant, natural products like pigments, glycerol, carotinoides, and antifouling products, aquatic cell line, transgenic fish and bioremediation (aquaculture farms and oil pollution). With a large coastline, India has made progress in marine research over a period of time. India has bagged patents in marine research from various institutes conducting research work in various aspects of marine biology. Some of the research areas are aquaculture, marine biotechnology, marine fisheries, systematic and ecology, molecular taxonomy, processing technology, shrimp and oyster hatchery management, endocrinology, marine bio-deterioration, microbiology, mangrove ecology, toxic algal blooms, biodegradation of oil spills, enzymes from marine systems, marine biodiversity. "Indian labs are concentrating on bioactive substances from marine animals such as horseshoe crab, green mussels, sponges and corals for characterization of novel molecules. Some of the novel molecules have been isolated and commercialized. The Department of Biotechnology (DBT) has been promoting marine biotechnology in India for the last one and half decades. Many R&D programs on marine biotechnology sponsored at different Indian Universities and Institutions and in collaborative mode are leading towards products and process development and development of viable technology for commercial production systems," said Dr AS Ninawe, director, DBT. Marine biotechnology also called marine bioprospecting in India, began in the early Nineties as the national project on development of potential drugs from the sea. The Central Drug Research Institute, Lucknow is the co-ordinating body together with several other collaborating institutes and universities. Organisms from both the long Indian coastline, particularly the mangroves of the Sundarbans and the Andaman & Nicobar Islands are identified, screened and specimens stored at the national repository at the National Institute of Oceanography, Goa. Prominent Indian institutes such as the Central Institute of Brackish Water Aquaculture, Central Institute of Fisheries Technology, Cochin, Central Marine Fisheries Research Institute, Central Salt and Marine Research Institute, National Bureau of Fish Genetic Resources, National Centre for Antarctic & Ocean Research, National Institute of Oceanography, National Research Centre on Coldwater Fisheries, and MS Swaminathan Research Foundation, Chennai have been working on projects related to the marine sector. Dr Shanta Achuthankutty said, "In India this science is really in its infancy except in the field of aquaculture. Certain universities have contributed to the field of marine biotechnology such as Cochin University of Science and Technology, Mangalore University and Bharthiyar University, Trichy. However, the work has been sporadic depending on the availability of grants and has not been the national thrust area. Although the DBT has a program in marine biotechnology and is conducting an MSc course, there are very few institutes/companies absorbing marine biotechnology candidates. So the students tend to move over to general biotechnology or quit for green pastures. Realizing the importance of marine resource, the CSIR has included marine microorganisms in its two networking projects. I think India should start an institute on marine biotechnology (R&D) wherein the charter should be on basic research on the functioning of marine organisms. It will be the answer for many metabolic disorders in our system, to develop sustainable energy, new assay methods for bioactive screening, enzymes in collaboration with the big players/industries." Government initiatives Along with the opportunities and vast potential for marine biotechnology, there are some hindrances that marine biology or biotechnology research encounters. The challenges include identifying new sources of marine bioproducts, developing novel screening technologies, providing a sustainable source of supply, optimizing production and recovery of the bioproducts, developing cultivation techniques for marine organisms, cloning of genes of interest, successful technology transfers for industrial growth and culturing marine organisms in the lab. The Indian government has been making all efforts to support research activities and initiatives in marine biotechnology and related areas under different programs. Spelling out the initiatives of the government, Dr A S Ninawe said, "The DBT has set up a task force on aquaculture and marine biotechnology, under which the projects are funded for utilizing marine resources for exploitation and products and processes from marine organisms utilizing biotechnology tools and techniques. Aquaculture is also part of marine biotechnology, which includes aquaculture biotechnology for the improvement of germ plasm, breeding techniques and genetic improvement. The DBT regularly organizes seminar symposia through HRD program through which marine biotechnology conferences are supported. One such good conference is going to be held in November in Cochin (organized by NIO, Goa). So far, the DBT has transferred five technologies under marine biotechnology. Most of the biotech companies are working on biopharmaceuticals. A few of them have just started concentrating on marine organisms for novel product and process development i.e. therapeutics of marine origin. Many states are coming forward for support of marine incubator facilities." Even states like Kerala, Tamil Nadu, Andhra Pradesh, Gujarat, Karnataka, Maharashtra, Orissa, and West Bengal are keen on promoting marine biotechnology in their respective states. Maharashtra's biotechnology policy includes efforts to exploit the marine organisms along its coastline; Karnataka biotech policy plans to set up a marine biotech park at Karwar to promote marine biotech. Marine bioprospecting is a major theme of Kerala's biotechnology policy. Kerala too plans to set up a biotechnology park at Cochin, which would have marine biotechnology as the thrust area. The Orissa draft biotechnology policy too has plans for a marine biotechnology park at Chilka Lake, one of the largest lagoons in India famous for its prawns. Chennai has become a hub for many marine biotechnology companies such as Cellgen Biologicals, Samudra Biopharma, GeoMarine Biotechnologies and ABL Biotechnologies. Hence the government of Tamil Nadu plans to set up a marine biotechnology park near Mandapam. Not behind is Andhra Pradesh. The state is pushing for marine biotech park spread over an area of 218 acres of land at Vishakhapatnam, where Celgen Biologicals, a wholly owned subsidiary of ABL Biotechnologies, is setting up India's first facility for the production of the essential fatty acid DHA. Biogenus, a US-based company has signed a MoU with the Andhra Pradesh government to invest $20 million for a marine biotech research station and bacterial culture and enzyme plant in the park. Gujarat too is active in promoting marine biotechnology. It has already set up a Center of Excellence (CoE) for marine biotechnology at CSMCRI, Bhavnagar. The state government has been organizing seminars on marine biotechnology to get the feedback from academicians, scientific community and industrialists, so as to prepare a road map for entrepreneurs. Akshay K Saxena, mission director, Gujarat State Biotechnology Mission, Department of Science & Technology, Government of Gujarat, said, "Gujarat has been making all efforts to promote marine biotechnology in the state. In this regard we had organized a day-long summit in January 2006, focusing on drawing out some conclusive bottomlines for promoting marine biotechnology in the state. The findings from this summit were aimed to aid, to device long term and short-term strategies, which would lead to fast track development of marine biotechnology in the state. Similarly in July 2006, we organized a summit to gather inputs for setting up an incubator for marine biotechnology in the state." Brighter outlook The possibility of obtaining drugs and food additives from marine plants and animals is just unveiling its huge economic potential worldwide. India is blessed with a long coastline with shallow tropical seas surrounding most part of the continent. The time is ripe for the Indian industry to dive into the oceans and reap the benefits, which this huge natural marine laboratory offers. There will be huge employment opportunities in these industries and it is necessary to create a reserve talent pool in this area. The DBT has taken up initiatives in creating human resources, which is the need of hour for marine biotechnology sector besides funding projects. "Marine biotechnology will provide us with more technological tools and application. Several marine based pharmaceuticals are under active commercial development, ecosystem health is high on the public's list of concerns, and aquaculture is providing an ever-greater proportion of the seafood in developed countries. Nevertheless, marine biotechnology has not yet caught the public's, or the investor's attention in India," felt Dr Shanta Achuthankutty. It is high time the successful marine biotechnology entrepreneurs brief venture capitalists at forthcoming conferences like BIOInvest and IVCJ conference scheduled in November 2006 in Mumbai, about their success stories. This might be interesting for VCs or private equity funds to make investments beyond biopharmaceuticals, bioservices, and bioinformatics sectors. Narayan Kulkarni ]]> <![CDATA[Gardasil to prevent cervical cancer]]> https://biospectrumindia.com/news/95/2341/gardasil-to-prevent-cervical-cancer.html https://biospectrumindia.com/news/95/2341/gardasil-to-prevent-cervical-cancer.html Wed, 18 Oct 2006 15:17:00 +0530 Gardasil to prevent cervical cancer Gardasil to prevent cervical cancer Within 10 days of its launch 10,000 doses of Gardasil were sold. In 2007, the world's first cancer vaccine is expected to contribute $40â€“$50 million in royalties from Merck, to whom CSL has licensed the technology. Many more such vaccines are on the way. Close on the heels is GSK's Cervarix, which is in the final stages of trials. World's first cervical cancer vaccine Merck's Gardasil has been approved as the first and only vaccine in the European Union for use in children and adolescents. Earlier, this year in June, the vaccine had received approval from US Food and Drug Administration as well. Gardasil can eliminate most new cases of cervical cancer worldwide. It blocks four strains of human papilloma virus (HPV), including two that give rise to nearly 75 percent of cervical cancer cases and two other strains that cause about 50 percent of genital warts. Set to become a blockbuster cancer therapeutic, Gardasil according to Australian analysts, will be one of the first Australian pharmaceutical successes. The technology for the world's first cervical cancer vaccine, result of 20 years of arduous research by Brisbane-based Professor Ian Frazer, was licensed by Australia's biotech major CSL to Merck and Co. Inc., which then led basic and clinical research programs leading to development of Gardasil. CSL markets Gardasil in New Zealand and Australia while Merck has marketing rights for the rest of the world. Within 10 days of Gardasil's launch, CSL had sold approximately 10,000 doses. Merck sales are also expected to soar in the fiscal 2007. In its recent financial statement, CSL stated that Gardasil is expected to contribute $40â€“ 50 million in royalties from Merck, the licensee, in 2007. According to estimates Merck's earnings per share will rise to $2.43 from $2.39 with an estimated $1 billion in US Gardasil sales, which are projected to reach $1.7 billion in 2010. However, Merck's Gardasil will soon face severe competition from GlaxoSmithKline's Cervarix, which is expected to hit market soon. Cervarix is another cervical cancer vaccine being tested for the prevention of Human Papillomavirus (HPV), and is in the final stage of clinical trials. Analysts predict that Merck's Gardasil will have global sales of $492 million by 2010, while GSK's Cervarix, expected to enter market in 2007, will have global sales of $345 million by 2010. There will be a head-on-head competition between Merck and GSK in treating this cervical cancer, which kills about 2,90,000 women worldwide each year. Merck has also taken full financial and administrative responsibility for Stimuvax, Canada-based Biomira's lead cancer vaccine. All future development, regulatory, commercialization and marketing costs for Stimuvax will be borne exclusively by Merck KGaA. Biomira will be responsible for commercialization and marketing costs related to Canada. Merck, currently, is looking at opportunities to get this product to market as quickly as possible. But Merck and GSK are not the only ones trying to capitalize on the cancer opportunity. Seattle-based Dendreon Corporation hopes to market its investigational immunotherapy for the treatment of advanced prostate cancer, Provenge, commercially in 2007. Dendreon is spending approximately $100 million per year for clinical trials of the vaccine. When it hits the market, it is sure to be a runaway hit for the company, doubling its investment capital. Analysts estimate it has a potential of $500 million in sales on its launch. Worldwide cancer vaccine revenues are estimated to reach approximately $6 billion by 2010. With over 75 companies actively pursuing research in cancer vaccines, it is estimated that over the next six years, by the end of 2011, 105 cancer vaccines would reach commercialization. It is also estimated that there are 18 vaccines being actively developed in Phase III. Just to name a few, Therion's Panvac-VF is entering a Phase III study for refractory pancreatic cancer and Prostvac-VF is in Phase II study for metastatic, androgen-independent prostate cancer. Therion is also working closely with the National Cancer Institute, Aventis Pasteur, and a network of leading clinical institutions to develop treatments for other major cancer indications. American biotechnology company, Antigenics also plans to launch its lead product candidate Oncophage (vitespen), a personalized cancer vaccine in Phase III trials and has been granted fast track and orphan drug designations by the US Food and Drug Administration for kidney cancer and melanoma. Melanoma has high development interest among vaccine developers, with 30 vaccines manufactured by various biopharmaceutical firms in various stages from preclinical to Phase III. Other targets for the vaccine developers include lung, prostate, breast and colorectal cancers, which have 23, 22, 21 and 20 vaccines in the development stage, respectively. According to the World Health Organization, more than 11 million people are diagnosed with cancer every year. It is estimated that there will be 16 million new cases every year by 2020. Cancer causes seven million deaths every year that is 12.5 percent of deaths worldwide. Cancer vaccines, in addition to offering a novel treatment option also have high market potential in terms of revenues. The traditional view on vaccines as a low-growth, low-price business has changed. The cancer vaccine pipeline is growing everyday, with focus on tackling organ specific tumors. However, the wait for a possible 'universal' cancer vaccine, for an immune response against cancer cells that originate from just-about-any-tissue, continues. Hasthana Rajappa ]]> <![CDATA[Imtech develops novel clot-buster for thrombolytic therapy]]> https://biospectrumindia.com/news/95/2666/imtech-develops-novel-clot-buster-for-thrombolytic-therapy.html https://biospectrumindia.com/news/95/2666/imtech-develops-novel-clot-buster-for-thrombolytic-therapy.html Wed, 18 Oct 2006 15:14:00 +0530 Imtech develops novel clot Imtech develops novel clot-buster for thrombolytic therapy Nostrum Pharmaceuticals will carry out clinical development of CSSK Coronary artery disease (CAD) is a rampant problem worldwide and the current rate of CAD-based deaths is increasing at a particularly alarming rate. Though clot-buster drugs such as tissue plasminogen activator (tPA) Urokinase (UK) and Streptokinase (SK) have revolutionized the treatment of myocardial infarction in recent years, the quest for an affordable, better clot-busters with fewer side effects and greater target specificity has remained a big challenge worldwide. The Institute of Microbial Technology (Imtech), Chandigarh, a constituent laboratory of the Council of Scientific & Industrial Research (CSIR), has been working in this direction and has developed a novel clot-buster for thrombolytic therapy. This Clot Specific Streptokinase (CSSK) is an engineered protein produced by recombinant DNA technology. The cDNA coding for Streptokinase has been fused with the cDNA of another naturally occurring human blood protein. The resulting hybrid protein is a product that has a very high affinity for the blood clot while it does not have any plasminogen lysis property. However, upon binding to the blood clot protein fibrin, the hybrid protein is lysed into its individual component proteins. As a result, streptokinase is released and is active only in the vicinity of the blood clot. Therefore, the common problem of blood thinning associated with Streptokinase due to general and widespread plasminogen lysis in the blood that can cause severe bleeding and hence death in some cases, will be avoided when CSSK is used. Imtech has already obtained a European patent for this molecule, and the Indian and US patents are pending. Now this therapeutic protein has been licensed to Nostrum Pharmaceutical, a privately held company based in Edison, New Jersey, USA, that develops and commercializes products using novel drug delivery systems for generic and branded pharmaceuticals in the US. Nostrum will develop this therapeutic protein in association with Symmetrix Pharmaceuticals, an affiliate of Nostrum Pharmaceuticals and carry out clinical development and commercialization of the novel clot-busting therapeutic protein. Symmetrix, was founded by Dr Yatindra Prashar, a renowned biotechnologist and scientific co-founder of Gene Logic, a Gaithersburg, Maryland based biotech company. Once developed, the CSSK will have a great potential both in the developing countries and the worldwide markets. Expressing happiness over this technology licensing tie-up, Kapil Sibal, Cabinet Minister for science and technology, opined that the research being carried out by many of the R&D institutions in India are now coming at par with those from globally recognized companies. Sibal was particularly happy to note that the tie-up represented a "brain gain" for India. Dr Nirmal Mulye, president and founder of Nostrum Pharmaceuticals, said, "The development of CSSK is the result of remarkably ingenious protein engineering research at Imtech and we are very excited about taking this therapeutic protein into clinical development since CSSK works in a highly clot-specific manner and hence overcomes the major problem of blood thinning that is otherwise associated with Streptokinase". Lauding Imtech for this achievement, Dr RA Mashelkar, director-general, CSIR, said, "This development represents a paradigm change in the working of government sector Indian R&D labs from primary basic research driven programs to the ones which can be commercially exciting as well. Dr Girish Sahni, director, Imtech said, "Nostrum, a technology-driven company has the focus and agility of a small company, and access to intellectual and financial resources to pursue clinical development of a molecule that has a huge commercial potential in the market worldwide". Sharing financial details of the technology licensing agreement, Dr Sahni said, "The agreement involves payment of $100,000 initially to Imtech, apart from several milestone payments and other royalties at different levels". Nostrum has plans to launch the product in India to start with. The product launch would take about three years, during which the required regulatory approvals would be obtained. Rolly Dureha Treating depression may raise anxiety levels Anovel research conducted by scientists at the National Center for Biological Sciences (NCBS) has shed new light on the recent clinical reports of patients who suffer from high levels of anxiety when they are subjected to anti-depressant treatment. A team of scientists led by Dr Sumantra Chattarji discovered that a molecule called brain-derived neurotrophic factor (BDNF), found naturally in the brain is responsible for neural changes associated with chronic stress. More specifically, it is a protein which has activity on certain neurons of the central nervous system and the peripheral nervous system; it helps to support the survival of existing neurons, and encourage the growth and differentiation of new neurons and synapses. In the brain, it is active in the hippocampus, cortex, and basal forebrainâ€“areas vital to learning, memory, and higher thinking. Animal studies and test tube (in vitro) models have shown that certain neurotrophic factors like BDNF are capable of making damaged nerve cells regrow and reduce depression. Because of this capability, these factors represent exciting possibilities for reversing a number of devastating brain disorders, including Alzheimer's disease, Parkinson's disease, Lou Gehrig's disease, and HD. Major depression and other chronic stress related disorders, like post traumatic stress disorder (PTSD), cause change in the physical structure of the brain. In order to survive and make connections, neurons require support from the BDNF molecule. Scientists observed that both physical and behavioral changes are attributed to the lack of support from this BDNF molecule. Scientists at the Yale University first suggested this neurotrophic hypothesis. To further test this neurotrophic hypothesis, Dr Sumantara Chattarji and colleagues investigated the role of BDNF molecule in depression using genetically engineered mice. In their test, the level of BDNF was increased in the mice and also they were subjected to a battery of behavioral and morphological analysis to determine their response to stress. The researchers found that BDNF acted as an antidepressant and also prevented damage in the hippocampus. However, the enhanced levels of BDNF molecule increased anxiety and also increased connections between neurons in the amygdala that plays an important role in processing emotional information. The researchers suggest that BDNF's action on different brain regions not only serve as a useful model to help explain the reason why some antidepressants increase anxiety but also opens up the possibility of discovering new effective drugs for countering the debilitating effects of stress disorders.   ]]> <![CDATA[We would try to match the students with appropriate colleges and universities in the US]]> https://biospectrumindia.com/news/95/1960/we-would-try-to-match-the-students-with-appropriate-colleges-and-universities-in-the-us.html https://biospectrumindia.com/news/95/1960/we-would-try-to-match-the-students-with-appropriate-colleges-and-universities-in-the-us.html Wed, 20 Sep 2006 11:50:00 +0530 New Page 1 "We would try to match the students with appropriate colleges and universities in the US" Jackson Blair Consultants (JBC) provides high level human resource consulting to executives, both individual and corporate, in the international arena. JBC, formerly known as Life Management, was founded by Dr Jackson Blair who holds BA and MBA degrees and a PhD awarded by UK-based Warnborough University honoris causa. In an interview, Dr Blair speaks about the services his company offers. How can JBC help Indian students seeking higher education in the biotech arena in the US? We do not specialize in biotech. That said, we would try to match the students with appropriate colleges and universities in the US. We would go about this by reviewing and analyzing their preparation and their stated career and educational goals. We would contact colleges and universities that seem best suited to these goals and determine the degree of interest in the student as an applicant. If encouraged, we would then work with the student to prepare the necessary papers for admission. Once admitted, we would help the students in making their travel plans to the US, securing accommodation (if not living on campus) and we would offer guardianship services if desired by the students. The guardianship services help students handle difficulties that arise with immigration, legal problems, medical problems, or disciplinary issues at the school. Essentially, we act as local guardians and help the student or the family handle emergencies and make decisions. There are fees for all of these services and the fee structure depends on the depth of involvement for JBC. Do you also help in placement of students? We use our executive coaching model in helping place students. We take an approach not dissimilar from that outlined in finding the right college or university when we look for the best "fit" for a career move. The first job is an important first step in any career and many students fail to properly structure and execute this process. Many students will receive excellent assistance from the Career Planning and Placement Office of their college or university. For those wanting that "extra advantage", we would consider assisting them in their identification and selection of a first job. We do not accept all students for this service. We would be most interested in an ongoing working and coaching relationship with the student as they progress through their career. Our organization was previously called Life Management. Essentially, that is the approach we take to career planning. Are you planning a similar initiative for other countries in the Asia Pacific region? Our clients are not country-specific. We work with individuals in the areas of private school, college or university placement. We then work with individuals as they build their careers. One of our senior consultants served as assistant dean and director of career planning and placement for the Fuqua School of Business at Duke University. He would be involved with our clients in this type of consulting. I was a member of the Professional Development Committee for the College Placement Council of the United States. I also offer consultation services in this area. Do you help students with financial assistance for their studies (life sciences segment) in the US? We would assist students in applying for financial aid at their chosen US college or university. Sometimes the paperwork is daunting. As part of our coaching effort, we would work through that with the student or the student's family. We can also arrange study trips for students so that the long vacation periods typical of private school, undergraduate and graduate schools in the US can be productive. These are individually arranged, and occasionally guided, tours throughout the US. We also offer a Global Adventure Program in partnership with Outward Bound South Africa which is a three-week outdoor experiential educational program that includes community service. Rolly Dureha   ]]> <![CDATA[Asian Institutes Increase Student Intake]]> https://biospectrumindia.com/news/95/2989/asian-institutes-increase-student-intake.html https://biospectrumindia.com/news/95/2989/asian-institutes-increase-student-intake.html Wed, 20 Sep 2006 11:45:00 +0530 Asian Institutes Increase Student Intake Asian Institutes Increase Student Intake Knowledge is not limited to national boundaries in today's cohesive world. The international migration of students for education is more of a norm than an exception now. The 1990s saw a tremendous increase in transborder movement of students for higher degrees. For Asian students, although the US tops the list of dream destinations, many Asian countries are attractive options as well. With science and technology becoming the key driver of development in Asia, scientific educational institutes with international standards have also come up. A number of countries in this region like Australia, Japan and Singapore have increased foreign student enrollment in recent years. In 2004, more than 84,000 foreign students, mainly from the Asian region, enrolled at the undergraduate and graduate levels in Japan, of which about 50,000 enrolled in science and engineering fields. Here is a snapshot of select Asian countries and institutes, which are bullish on life sciences education. Australia: A rich history in science and technology Australia is a leader in life sciences education and research. Australia is one of the top three destinations for international students. According to statistics, in 2004, it attracted over 3,22,000 international students from over 190 different nationalities. New life sciences course work gets implemented each year keeping the students, researchers and other personnel in the forefront of biological innovation. Life sciences education in Australian universities is supported by investment from the government and industry. The Australian government support includes various programs under Backing Australia's Ability-a five-year $3 billion innovation action plan launched in 2001. Further Australia's science and innovation performance will be boosted through a $5.3-billion package that strengthens the successful "Backing Australia's Ability" program. Together these packages constitute a 10-year, $8.3-billion funding commitment stretching from 2001 to 2011. Combined with other science and innovation programs, they take the Australian government's 10-year investment in this key area to around $52 billion. Universities and institutes Australia has about 37 government-funded universities and two private universities, as well as a number of specialist institutions providing approved courses at the higher education level. Most of the Australian universities offer courses in life sciences. They are the Melbourne University, Australian National University (ANU), University of New South Wales, Curtin University of Technology, Deakin University, Edith Cowan University, Flinders University and many others. Many universities have international collaborations as well. The faculty of ANU is internationally linked with universities such as Oxford and Cambridge, Singapore and Beijing, Osaka and Seoul, California and British Columbia. Similarly, the University of New South Wales (UNSW) has set up an Asian arm, UNSW Asia, which will open its doors in Singapore in March 2007 and shall offer a comprehensive range of undergraduate, postgraduate and research degrees in diverse arenas including science. A new research institute for molecular science and biotechnology, known as the Bio21, was set up recently at the Melbourne University. It is one of Australia's largest biomedical research centers and home to 230 researchers, including postgraduate students, from 12 different disciplines. Australian universities are increasingly providing unique specializations to ensure personnel and students stay abreast in life sciences as so many new fields have emerged (bioinformatics and proteomics) and each new technology leads to new capabilities and new issues (eg: bio-security, stem cell research). Most of the undergraduate life science courses last for three years and a majority of the courses start in February. Some of the courses also begin in July and October. Applications to study at Australian institutes can be sent directly to the institutes. Scholarships Most of the universities have a range of scholarship opportunities to offer. For example, the ANU offers international students from any country five full undergraduate tuition scholarships and four full undergraduate tuition scholarships for a student from each of Hong Kong, Malaysia, Singapore and Thailand. Likewise the UNSW provides many scholarships for international students. They include the Endeavour International Postgraduate Research Scholarships (EIPRS) and University International Postgraduate Award (UIPA). These scholarships are highly competitive. In addition, there are general as well as faculty specific scholarships for the undergraduate programs of study like the Alton and Neryda Fancourt Chapple Biological Science Scholarship; The Dean's Honours Year Scholarship; Children's Cancer Institute Australia (CCIA) Honours Scholarship amongst others for studies in the life sciences arena. China: A silent progressive revolution China China: A silent progressive revolution China has emerged as one of the fastest growing centers for education China has a long history of having students from foreign shores studying in its institutes and out of the 2000 plus universities and colleges, more than 300 have overseas students on their campuses. There are well over 1 lakh foreign students studying in China, who have flocked from more than 164 countries across the world, though a majority of them (nearly 70 percent) are from the Asian region. Universities and institutes Beijing Institute of Technology, China Agricultural University, Fudan University, Harbin Institute of Technology, University of Science and Technology of China, Nanjing University, Peking University are some of the prominent institutes offering courses in life sciences. Candidates aspiring for a Chinese degree have to go through a national examination and only those whose exam scores are up to the required standard can become registered students to study for a degree there. Most of China's institutions of higher learning operate on a centralized enrolment system in which admissions committees at the provincial level operate under the aegis of the Ministry of Education. The nationwide examinations are during the first half of July. The tests themselves, issued by the Ministry of Education, fall into two categories-the humanities, and the sciences and engineering. While candidates can appear for only one of the two, they can list the institutions and departments they wish to join in order of preference. Scholarships Scholarship programs are bilateral exchange programs, and those who want to apply to study in China on a Chinese scholarship have to go through their government. Private students can send their application directly to the university or college that they wish to study in. India: A center for learning India India: A center for learning India has one of the largest higher education programs. Higher education in India has gone through a big paradigm shift and become more international. With over 226 universities and thousands of colleges affiliated to them, about 428 engineering colleges and technological institutes, more than a 100 medical colleges, scores of agricultural institutes and many other specialized centers of learning and research cross cutting across disciplines, India can claim its position as one of the leading countries providing quality higher education. Universities and institutes There are three principle levels of qualifications within the higher education system in India. These are bachelor/undergraduate level, masters/post-graduate level and doctoral/pre-doctoral level Diploma courses are also available at the undergraduate and postgraduate level. The academic session is yearly and generally starts in July or August while admission starts in the month of May/June on the basis of written examination or interview. Some universities/institutes reserve a limited number of seats for foreign students/NRI students, which are given on the basis of the applicant's academic record. The Jawaharlal Nehru University, Indian Institutes of Technology and the Indian Institute of Science are some of the internationally acclaimed institutes for a higher degree in life sciences. Some of the important universities offering high technology courses in this arena are the University of Hyderabad, Anna University, Madurai Kamaraj University, Institute of Chemical Technology, Pune University and a few other universities. Scholarships Every year a few scholarships are offered to international students according to the terms and conditions of the cultural exchange program signed between the Indian government and the government of the respective country, for studying, training and research in various fields. There is a General Cultural Scholarship Scheme (GCSS), where scholarships are awarded annually to international students belonging to certain Asian, African and Latin American countries for the undergraduate, postgraduate degrees and for pursuing research at Indian universities. Other international scholarships available are Commonwealth Fellowships, Technical Cooperation scheme of the Colombo plan, Reciprocal Scholarship Scheme and the SAARC Scholarship scheme. Japan: Favorite destination for international students Japan Japan: Favorite destination for international students Science and technology is the driving force behind Japan's development. The greatest appeal of studying in Japan is its academic environment where one can study state-of-the-art technology and acquire the knowledge that enabled Japan's phenomenal postwar economic growth. Japan promotes the acceptance of foreign students from various nations around the world. This is evident from the fact that in 2004, more than 84,000 foreign students enrolled for undergraduate and graduate levels in Japan, of which about 50,000 enrolled for science and engineering disciplines. Significantly, about 90 percent of the international students who study in Japan come from other parts of Asia. Universities and institutes There are about 700 universities in Japan, including national, state and private universities. Foreign students can enroll for one of the five types of institutions of higher learning: universities (undergraduate courses), graduate schools, junior colleges, special training colleges (post-secondary courses) and colleges of technology. The duration of study in an undergraduate university is four years with the exception of medicine and veterinary science department, which require six years of study. The study duration in a graduate school depends on whether a student has enrolled for a masters or doctorate program. The duration of the masters program is two years, while that of the doctorate program is five years, including the first two years of the masters degree. Some important universities offering life sciences courses in Japan include Gakushuin University, Graduate University for Advanced Studies, Gunma University, Hiroshima Shudo University, Hokkaido Tokai University, Kyoto University, Nagasaki University, Osaka University, Science University of Tokyo, Tokyo University, Yokohama City University and many others. Scholarships There are several types of Japanese government-sponsored scholarships available: those for research students, undergraduate university students, college of technology students and special training students, besides a host of other schemes. Singapore: Leader in biomedical sciences Singapore Singapore: Leader in biomedical sciences The fourth pillar of Singapore's economy is the specialized arena of biomedical sciences. Singapore had been poised to launch a new direction in economic development post 2000. After the announcement of the first draft of human genome in June 2000, the Singapore government decided to launch biomedical sciences as the fourth pillar of industry. The focus on biomedical sciences has been due to some good reasons. As opposed to the existing chemical, electronics and engineering industries, which faced regional competition due to low labor cost, biomedical sciences has a "high barrier entry" as it is very capital intensive. It is a high-end industry and needs a lot of good, well-researched products. Moreover, the potential for the growth of the biomedical sciences is tremendous as against agriculture and non-medical devices. The global human therapeutic industry will be worth $27 billion by 2008 and human diagnostics will be a $4.3-billion industry. Universities and institutes There are three local universities in Singapore-The National University of Singapore (NUS), Nanyang Technological University (NTU) and the Singapore Management University (SMU). In addition, BioPolis, the biomedical research hub of Singapore, has 12 A*STAR (Agency for Science, Technology And Research), like the BioInformatics Institute (BII), the Bioprocessing Technology Institute (BTI), the Genome Institute of Singapore (GIS), the Institute of Molecular and Cell Biology (IMCB) and the Institute of Bioengineering & Nanotechnology (IBN) which conduct a variety of short and long-term training programs in association with the universities. In addition to local universities, leading international universities have increased the level and scope of tertiary education in Singapore. Some leading international universities, which have collaborated with local institutions to launch their presence in Singapore include Georgia Institute of Technology-The Logistics Institute, Asia Pacific, Johns Hopkins University-Johns Hopkins Singapore, Massachusetts Institute of Technology (MIT)-Singapore MIT Alliance, Shanghai Jiao Tong University, Stanford University-Singapore Stanford Partnership, Wharton School of the University of Pennsylvania-Wharton SMU Research Centre and the Technische Universitat Munchen-German Institute of Science and Technology. Scholarships The ASEAN* Undergraduate Scholarship (AUS) is awarded to freshmen who are citizens and permanent residents of a member country of ASEAN. SembCorp Industries Undergraduate Scholarship is another popular scholarship. South Korea: Highly competitive South Korea South Korea: Highly competitive South Korea has experienced a spectacular expansion of higher education. The Korean educational system has undergone a series of reforms and the Korean universities have expanded rapidly since 1970. In fact, the number of students and professors in four-year universities have increased 11 times and seven times between 1970 and 1999 respectively. Focusing on higher education, the Ministry of Education launched Brain Korea 21(BK21), a human resource development program, which targets seven important areas in science and technology necessary to enhance national competitiveness in the 21st century. Incidentally, biotechnology, which encompasses agriculture, medical science and environment, is the first target area selected for program implementation. The South Korean government has recently allocated the second round of funding for the 'Brain Korea' 21 (BK21) project, allocating $2 billion over seven years to strengthen further the country's post-graduate competitiveness. For 1.6 million students approximately 184 million dollars are presently being invested in the public and private four-year Korean universities. Universities and institutes The Seoul National University (SNU) is amongst the leaders of higher education in Korea and is known for its quality graduates. The founding of SNU in 1946 marked the opening of the first national university in modern Korean history. Besides SNU, some other premier universities and institutes offering life sciences courses in Korea include Korea Basic Science Institute, Korea Institute of Science and Technology, Korea Research Institute of Chemical Technology, Andong National University, Cheju National University, Chonnam National University, Korea Advanced Institute of Science and Technology , Kwangju Institute of Science and Technology, Phohang University of Science and Technology, Sunchon National University, Suwon University, University of Seoul, and Yonsei University. Scholarships International students have attractive chances of being awarded scholarships. The Ministry of Education offers a scholarship program for foreign students from countries that have concluded a bilateral cultural agreement with Korea. A few other outside scholarships include Korea Foundation Fellowship for Graduate Studies; Korea-Japan Cultural Association Scholarship; and the Overseas Korean Foundation Scholarship. Besides, most of the Korean universities also provide scholarships for international students. The Seoul National University offers SNU Tuition Scholarship in addition to a limited number of work scholarships by the individual departments or professors. There are two types of work scholarship opportunities available-Teaching Assistant (TA) and Research Assistantships (RA), where the students receive a partial tuition waiver as well as a monthly stipend. Rolly Dureha ]]> <![CDATA["We work with companies which give us unique propositions to build capabilities"]]> https://biospectrumindia.com/news/95/1449/we-work-with-companies-which-give-us-unique-propositions-to-build-capabilities.html https://biospectrumindia.com/news/95/1449/we-work-with-companies-which-give-us-unique-propositions-to-build-capabilities.html Mon, 11 Sep 2006 15:02:00 +0530 New Page 1 "We work with companies which give us unique propositions to build capabilities" Pradeep Nair, vice president, global life sciences practice, HCL HCL Technologies, which is part of $3-billion HCL Enterprise, is one of India's leading global IT service companies. It has been one of the early movers in the life sciences and healthcare areas. The life sciences practice started in July 2003 and within a short span of three years, it has emerged as the fastest growing vertical at HCL. In an exclusive interview, Pradep Nair speaks about the forays of the company in this niche space. What are the different focus areas at HCL Life Sciences? Essentially, we are in the services space and whatever we develop is for the customer. We are focusing on some frameworks, which are driven by regulatory compliance. We are the first company to develop the Structure Product Labeling (SPL) framework. We have developed a framework on Removal of Hazardous Substances for Medical Devices (ROHS), which is again driven by the EU regulatory bodies. Second, we are in the area of clinical data management, which has a huge potential market and is a big growth area for us. We have a number of customers and as of today, we are sitting on about seven-eight enquiries on how we can help and support in clinical trials and data management. The third growth area is definitely our device business-working on Class I, Class II and Class III devices and designing the products, while the fourth is the manufacturing of the devices itself. These focus areas are in addition to our traditional business of application support and management which has also seen continuous growth. We have expanded our offerings from pure IT to the sales and marketing division of our customers, supporting some of the applications there. In addition, we also offer support for their manufacturing and execution systems. Could you elaborate on the regulatory frameworks developed by HCL? Earlier any data or any information that was submitt ed to the FDA was either paper-based or could be in a Word or PDF format. Since it was becoming difficult for the FDA to analyze the entire data, from last November they wanted everything to be submitted in an XML format, which is an extended markup language and helps slice and dice the data as and when required. So now for any preexisting drug, the data needs to be converted to XML and for any new product that the drug companies are launching, the data has to be submitted to the FDA on XML format. HCL has developed a tool-Structure Product Labeling (SPL) which helps in this conversion. When we launched this product, we were surprised to find that 70 percent of the queries came from the Indian drug companies. In future, we see a lot of potential in this segment. Then there is a concept called Removal of Hazardous Substances (ROHS), based on which a big legislation is coming up in the Europe. According to this, for any device in the market, all European companies have to go through the ROHS by 2009. Each and every design of the device has to be looked into for any hazardous metals like lead or arsenic or any other components that are damaging to the environment. Such a component has to be taken out and replaced by some hardware or software that can take care of the functionality. This area is a huge opportunity for us. We have developed a framework on ROHS and are working with a couple of device companies currently. This legislation will also result in a lot of customers trying to reinvent their products and we are seeing that companies are moving from Class I to Class III devices. Can you explain about your biomedical devices foray? From the device perspective, we are seen as a cradle to grave concept company. We come up with a concept, and then we design it, develop it and manufacture it as well. The customer comes with a concept and asks us, for example, to develop a drug delivery system which can be implanted in the body. It is a total iteration process where three consultant engineers from each field do a lot of research, come up with a concept and get back to the customer, present a model which is then fine-tuned. Once the concept is okayed, we do the software design, and we embark on the embedded high level design. Then we do the detailed design and the hardware design of the product. Today, the customer has asked us to even manufacture it. At present, due to the ISO 13485, MQMS standards, the biomedical devices can be tested and implanted in the body for more than eight years of life. We have developed a device, which can be implanted in the spine for pain conditions, where the drug can be infused at the patient's behest. Here we have taken the best practices from avionics and automobiles and planted it into the medical devices practice. What is your offering in the clinical data management arena? Though there are a lot of clinical trial/clinical data management solutions available along with the home-grown applications, they are not able to provide end-to-end solutions to the customers. This is why we have started moving into the data management arena and have developed some tools which have a lot of inbuilt flexibility. Data management during the phase I, II, III, IV, and the pharmacokinetic trials entails a lot of market analysis. Clinical data management is a huge opportunity today and it comes along with supporting the application of a pharma company. For example, for any drug that comes out, one develops a protocol on it and tries to develop software around it. Once the drug compound is out in the market for trials, the process of data analysis itself is a huge opportunity. We have recently tied up with a large drug company to support the whole process of clinical data management. Moreover, this year we will also focus on the healthcare side where we have not done much till now, as hospital solution providers. We will focus on hospital management system and application based infrastructure. Will HCL venture into the drug discovery segment as well? In drug discovery there are two parts-target identification and target validation. Right now our focus is on target validation. We have developed algorithms which help to predict the gene protein structure. So we are trying to offer our consumers a complete basket of products which helps them validate the targets. The end result will be reduction in the time and expense to market to get the drugs, which is the biggest challenge. What are the growth plans for this vertical? We are the only practice that is growing 100 percent and we will again grow 100 percent next year and from then onwards we will start to grow at a 60-70 percent basis. To support that, we need infrastructure in terms of people. So we are hiring dedicated delivery managers just for life sciences, who will work with all other technologies within HCL. We have also created a business solutions group having a team of 15 domain consultants. These people have over 15 years experience in the industry and are physicians, hospital administrators, compliance people who have worked with drug companies. We are also ramping up the sales force in the US and Europe and most importantly we are making our frameworks more robust from the product or framework perspective. What is the core business strategy at HCL? Our business strategy is pretty simple. We want to work with certain focused customers. We want to pick our customers, which is a very bold statement to make. But that does not mean that we will work for only the Fortune 1000 companies. We will also work with small start-ups who are creating certain niche products or getting into the new areas. For example, we are working for a very small start-up company based out of Boston, which is developing solutions in the pharmacogenomics space, which we think is the next trend in the area. So we work with companies which give us unique propositions to build capabilities. We keep ahead of competition in the application support space by offering regulatory frameworks and in to the devices segment. Does the HCL Life Sciences vertical have a presence in the Asia Pacific region as well? How different is the life sciences industry in these regions? HCL has operations in the US, Europe and the Asian region. We are using our Singapore office to enter the Asian region. We have acquired a customer in Singapore-SingHealth. Our Malaysian office is working with a device company offering SAP application support work. These countries have much more regulated processes than India. Rolly Dureha   ]]> <![CDATA[Gel electrophoresis equipment business booms]]> https://biospectrumindia.com/news/95/2763/gel-electrophoresis-equipment-business-booms.html https://biospectrumindia.com/news/95/2763/gel-electrophoresis-equipment-business-booms.html Mon, 11 Sep 2006 14:59:00 +0530 Gel electrophoresis equipment business booms Gel electrophoresis equipment business booms Increased research activities, coupled with more and more educational institutions offering courses in biotechnology and related disciplines, have opened up the market for electrophoresis equipment in India. Gel electrophoresis is a method that separates macromolecules, either nucleic acids or proteins, on the basis of size, electric charge, and other physical properties. It is is one of the staple tools in molecular biology and is of critical value in many aspects of genetic manipulation and study. One use is the identification of particular DNA molecules by the band patterns they yield in gel electrophoresis after being cut with various restriction enzymes. Viral DNA, plasmid DNA, and particular segments of chromosomal DNA can all be identified in this way. Another use is the isolation and purification of individual fragments containing interesting genes, which can be recovered from the gel with full biological activity. Gel electrophoresis makes it possible to determine the genetic difference and the evolutionary relationship among species of plants and animals. Using this technology, it is possible to separate and identify protein molecules that differ by as little as a single amino acid. The protein molecules in a sample of fish muscle tissue and plant grain endosperm tissue can be separated according to their individual molecular mass and compared to samples that have been treated with a reducing agent, such as 2-ercaptoethanol. Complex proteins (composed of two or more polypeptide chains) can be broken down into their respective polypeptide fractions. A reducing agent breaks the disulfide bonds that hold the polypeptide together. There are many players supplying electrophoresis equipment to the research community. The key players include Bio-Rad Labs, Bangalore Genei, GE Healthcare (formerly Amersham Biosciences) and Thermo Electron Corporation. In India, there are about 10 local players who manufacture electrophoresis equipment. These companies are Pune-based Advanced Technologies Corporation and Ambala-based Popular Traders. The local players mostly produce low-end products, and cater to the needs of schools, colleges, and research laboratories. There are many others who are into the business of trading these products. Medi Spec Instruments India represents Galileo Bioscience of the US; JH Bio Innovations represents US-based eGene for its capillary electrophoresis systems; Lark Laboratories represents a US-based company; Axygen Scientific represents Labnet International; and Quantum Biologicals represents Italy-based Cellogel Electrophoresis for its clinical electrophoresis. Popular Traders has been manufacturing gel electrophoresis equipment for the last 25 years. Starting with three models, today it manufactures 20 types of electrophoresis equipment. Sharing his views, Ajay Gupta, partner, Popular Traders, said, "With the biotech boom, we are now receiving a lot of enquiries from colleges, research labs, schools, universities for our range of electrophoresis products. Our products are available in the range of Rs 3,000-7,000 per unit. The market is also growing rapidly with more players offering a range of electrophoresis products with additional features. In the last few years, the growth was about 25 percent. It is now growing at a rate of 100 percent." However, he expressed concerns on the availability of raw materials and lack of testing centers for testing these raw materials. The market has been growing at a rapid rate in the last few years. Rima Singh, product manager, Bio-Rad Laboratories (India), said, " Now more organizations, both private and public sector, are actively involved in research activities. The state funding for research activities too has increased in the last few years. So there is an increase in the need for electrophoresis products. Gel electrophoresis equipment are available in the range of $1000 to $12,000 per unit. Approximately 200-300 units of electrophoresis equipment are sold every year." Bimal Desai, manager, marketing and sales, Thermo Electron LLS India, said, "Gel electrophoresis is more popular compared to capillary electrophoresis among the research community. Electrophoresis equipment are available starting from Rs 10,000 to few thousand dollars." Sharing his thoughts about the market, M Kannan, marketing manager, Lark Laboratories, which is importing electrophoresis equipment from the US companies, said, "The market for electrophoresis equipment is growing and there is a good demand from researchers and institutions." The biotech boom is definitely boosting the demand for electrophoresis equipment. The market could grow at a higher rate if it gets some more support from the government in terms of incentives to local manufacturers or more funding to research organizations/institutions. Narayan Kulkarni Ess Dee Aluminium files for IPO Ess Dee Aluminium files for IPO Ess Dee Aluminium files for IPO Ess Dee Aluminium Ltd (EDAL), a flagship company of the Dutta Group of Industries, has filed its draft red herring prospectus with the Securities & Exchange Board of India (SEBI) to enter the capital market with its proposed initial public offering (IPO). EDAL proposes to offer 69,60,000 equity shares of Rs 10 each for cash at a premium to be decided through a 100 percent book-building process. Of this, 1,50,000 equity shares are reserved for allotment to eligible employees, thus the net offer to public stands reduced at 68,10, 000 equity shares. The offer to public will constitute 25.79 percent of the post issue fully diluted equity capital. Of the net offer to public, the company proposes to reserve 50 percent for allotment to qualified institutional bidders and of this, five percent will be allotted to mutual funds. Of the balance, 15 percent is to be reserved for allotment to non-institutional bidders and the balance 35 percent is being reserved for allotment to retail investors on a proportionate basis. Sudip Datta, chairman and managing Director, Ess Dee Aluminium, said, "The IPO is an important milestone in realizing our larger corporate vision as we propose to set up a new unit to manufacture aluminium foil based packaging products to enhance our product portfolio and industry reach. It would help strengthen our position in the pharmaceutical packaging business and tap future growth opportunities in aluminium foil-based pharmaceutical, FMCH and food packaging business." Imperial's new corporate headquarters inaugurated Imperial Life Sciences (formerly Imperial Bio-Medics) inaugurated its new corporate headquarters in Gurgaon, a 15,000-sft facility which houses all departments including customer support, technology support, massive warehouse, human resources department and an application support lab. The application support lab is a fully equipped life sciences research laboratory, which houses instruments like QPCR, automated nucleic acid sequencers, nucleic acid isolation systems, robotic liquid handling stations and various types of thermal cyclers including speed cyclers, dual block and DDPCRs. The company plans to create a full-fledged microarray facility shortly at its new office. "This new sophisticated set up equipped with modern communication gadgets will ensure smooth functioning of the entire system and the ease of functioning will in turn be transferred to all the clients with faster turnaround times and prompt support," said Neeraj Gupta, corporate vice president, Imperial Life Sciences. Zensar to offer pharma services As a part of the strategy to structure integrated capabilities to meet the growing demands from pharma and biotechnology sectors, Zensar Technologies, a software and BPO services provider, has launched pharma consulting practice focusing on efficient and cost-effective solutions for the pharmaceutical and biotech sectors. With this launch, Zensar will offer customers best practices in compliance, enterprise solutions and technology advisory services. Zensar has also formed an advisory board by roping in professionals from IT and healthcare industries to enhance the offering to the pharma market. The board comprises Pradipto Mohapatra, CEO, RPG Life Sciences, Dr Ganesh Natarajan, MD, Zensar Technologies, Pramod Lele, CEO, Hinduja Hospitals, Ramesh Kodali, CEO, Zensarâ€“OBT, Laura Sherman, vice president, submission and validation, Impact, USA and John Nidelcheff, president, Impact, USA. Giridhar Rao, associate vice president, SAP business, Zensar Technologies said, "Industry trends and predictions show promise for the pharma industry. Zensar is looking at leveraging its innovative technology frameworks to customers with best practice in compliances such as current Good Manufacturing Practice (cGMP), and Electronic Common Technical Documents (eCTD). We will also offer enterprise solutions, and technology advisory services to organizations in this space." Ocimum Biosolutions sets up its German subsidiary Ocimum Biosolutions has set up its German subsidiary in Ebersberg (Germany) in order to expand its presence in the European market. This is a milestone for Ocimum after its successful acquisition of the microarrays division of MWG Biotech AG. The German subsidiary, Ocimum Germany GmbH, aims to tap the huge genomics market in Europe and provide quality R&D enabling solutions to universities, research institutes, biotech and pharma companies in Europe. Anuradha Acharya, CEO, Ocimum Biosolutions, said, "Eupore is a big market for us. We chose to base our European operations in Germany as it is centrally located in Europe. We are also planning to expand further in the market through acquisitions." Ludwig Winzer, managing director of the Ocimum Germany GmbH, said, "This is one more consequent step in Ocimum's overall strategy and a clear commitment to our customers." Ocimum Biosolutions emerged as the winner of NASSCOM IT Innovation in India 2005 Award for its innovative ideas and products. Deloitte Technology Fast 50 India 2005 Program, which honours the fast-growing technology companies, ranked Ocimum fourth among the 50 fast-growing technology companies in India. Wipro Biomed inks pact with Ciphergen Biosystems Wipro Biomed has entered into a strategic alliance with Ciphergen Biosystems. As per the agreement, Wipro Biomed will market Ciphergen's patented protein chip technology products and services for translational proteomics and biomarker discovery and development for India, Sri Lanka, Bangladesh and Nepal market. Built on over 15 years of biomedical experience, Wipro Biomed with three businesses- life science group, diagnostics system group and medical systems group, has more than 2000 customers. It has developed expertise in consulting, deploying, servicing and back up of bio-medical equipment. Biotron inks marketing pact with CISBIO Biotron Healthcare (India), which is engaged in the distribution of products, technology and services, has tied up with a French company, CISBIO International to offer HTRF based assays in India. The HTRF is a proprietary technology of CISBIO for the detection of biomolecular interactions and is widely used by the pharmaceutical industry for the high throughput screening stage of drug development. Venkatesh Voleti, director, sales, Biotron Healthcare (India), said, "New drug discovery research in India has seen a rapid growth over the last few years. Realizing the potential at an early stage, we have positioned ourselves to be one of the preferred vendors of solutions, instruments, kits and assays. The tie-up with CISBIO is a step further in this direction so as to bring cost effective primary and secondary screening solutions." Waters exhibits first of its kind mass spectrometry system At the triennial International Mass Spectrometry Conference, from August 27, 2006 to September 1, in Prague, Waters presented a host of new products debuted earlier this year. Highlighting Waters 2006 product news is the launch of a first-of-its-kind mass spectrometry system, the Synapt High Definition MS (HDMS), and a new collaboration with Applied Biosystems. The Synapt HDMS System is for researchers working at the limits of conventional mass spectrometry (MS) and who need to further characterize and define their samples. Waters also announced a new partnership with Applied Biosystems to offer direct support of Waters ACQUITY Ultra Performance LC (UPLC) System within Applied Biosystems Analyst software. Applied Biosystems joins Thermo Electron and Bruker Daltonics among the ranks of mass spectrometry companies collaborating with Waters to provide scientists with greater operational integration and connectivity between Waters ACQUITY Ultra Performance LC System and mass spectrometers from Applied Biosystems, Thermo, and Bruker. "Scientists have seen the unique advantages of using UPLC with mass spectrometry to increase throughput and performance. We are pleased to work with Applied Biosystems/MDS SCIEX to offer UPLC as a fully-supported LC inlet to the Applied Biosystems/MDS SCIEX family of mass spectrometers," said Rohit Khanna, vice president, worldwide marketing, Waters Corporation. Bio-Rad to acquire LS business from Ciphergen Bio-Rad Laboratories has signed a definitive agreement to acquire Ciphergen Biosystems' ProteinChip Systems and worldwide technology rights to surface enhanced laser desorption/ionization (SELDI-TOF-MS) for approximately $20 million in cash. In addition, Bio-Rad will make a $3-million equity investment in Ciphergen. This will provide Bio-Rad with access to leading protein analysis technology for the life science market and represents a significant addition to the company's portfolio of products. The acquisition includes manufacturing, sales, intellectual property, and a significant customer base. As per the agreement, Ciphergen will retain rights to the diagnostics market. Through a separate supply agreement, Bio-Rad will supply instruments and reagents to Ciphergen. The transaction is expected to close in the fourth quarter 2006 and is subject to approval by Ciphergen's stockholders and other customary closing conditions. "The study of proteins continues to be a rapidly growing area in the life sciences. With the acquisition of Ciphergen products, Bio-Rad will be able to provide a broad range of proteomic tools from basic separations to full identification of proteins," said Norman Schwartz, president and CEO, Bio-Rad. PerkinElmer collaborates with UK varsity to address PTB challenge PerkinElmer has announced a multi-year license and research collaboration agreement with the University of Leicester (UK). As per the agreement, the two organizations will begin to lay the groundwork for the clinical investigation and discovery of biomarkers that Predict Preterm Birth (PTB). This collaboration will be financed by PerkinElmer. Currently there are no rapid or accurate tests that positively predict preterm labor. The collaboration between PerkinElmer and the University of Leicester, which is home to one of Europe's foremost research teams dedicated to the study and prediction of PTB, is designed to effectively address the need and eventually design and supply an effective preterm labor test predictor. The partnership will give PerkinElmer broader access within Prof. JC Konje's research group to clinical samples, methodology and clinical consultancy support in the field of maternal health. D-10 platform from Bio-Rad D D-10 platform from Bio-Rad Bio-Rad Laboratories has launched D-10 HbA1c testing system. Till date BioRad has done more than 60 installations in India. The D-10 system is based on the "Gold standard" HPLC Technology (high pressure liquid chromatography) and is targeted at the mid size lab segment which performs 200-800 HbA1c tests every month. Now the D-10 platform is available with additional features in rack loading. The D-10 system has got all the necessary certifications and approvals from regulating bodies like the National Glycohemoglobin Standardization Program (NGSP), the USFDA and CE certificate. Apart from the HbA1c values, the report obtained from this analyzer also gives a chromatogram of the complete hemoglobin fractions like the Adult Hemoglobin, Fetal Hemoglobin, Hemoglobin A2 as well as any abnormal hemoglobins. For details, visit: www.bio-rad.com   Eppendorf introduces FemtoJet express Eppendorf has added FemtoJet express microinjector to its cell technology family. It is used for the injection of liquid in the volume range from femtoliters to microliters. An external pressure supply guarantees the permanent availability of higher injection pressures. Programmable injection parameters ensure high reproducibility. The FemtoJet express was developed for the needs in the fields of developmental biology and functional genomics. And it is suited for microinjection into small organisms (e.g. fruit flies) or embryos in an early stage of development. The injection parameters (injection pressure, injection time and compensation pressure) can be set easily and quickly via control buttons directly on the device. The integrated "clean" function enables quick rinsing of blocked capillaries. The main functions can also be operated with the supplied hand key or an optional foot key. The device can easily be integrated into automation processes via an RS 232 interface. For details, contact: info@eppendorf.co.in   BioTek launches NanoQuot microplate dispenser BioTek Instruments has introduced the NanoQuot microplate dispenser, a low volume liquid dispensing solution for the life science research and drug discovery markets. Sub-microliter dispensing offers scientists increased assay throughput and lower reagent expenses. The NanoQuot dispenses these volumes down to 100 nl precisely and accurately. NanoQuot will help researchers transition into high density, low volume microplate formats with an incomparable price-to-performance ratio, while also maintaining backward compatibility with existing formats and volumes. In India, MediSpec Instruments India represents BioTek Instruments for its range of equipment. For details, contact: chhatbarv@biotek.in   Millipore's new Stericup filter cups Millipore has announced an enhanced design for its Stericup filter cups. The fast flowing, low protein-binding cups sterilize tissue culture media, buffers and other aqueous solutions. The new ergonomic design incorporates recessed finger grips on the receiver flask that make it easier to hold, minimize slippage, and facilitate lab procedures. The performance results and quality specifications of the Stericup filter cups remain the same. Volume markings on the side of the cup are accurate and consistent with standard products. The no-tip Stericup filter cups are stable, compact and stackable. The threads of the bottle attachment are slightly recessed for added protection against contamination. The redesigned Stericup filter cups are available to process in 150 mL, 250 mL, 500 mL, and 1L volumes. Stericup devices are part of a family of Millipore sterile filtration products. Filter units are available in syringe, pressure, vacuum or pump-driven versions. Millipore also offers a wide range of pore sizes, configurations and volume capacities. For details, contact: millipore@vsnl.com ]]> <![CDATA[Flourishing or languishing ?]]> https://biospectrumindia.com/news/95/1472/flourishing-or-languishing-.html https://biospectrumindia.com/news/95/1472/flourishing-or-languishing-.html Mon, 11 Sep 2006 14:55:00 +0530 Flourishing or languishing Flourishing or languishing ? An overview of Taiwan's life sciences industry. When it comes to Taiwan's life sciences, there is much debate within the island over whether the sector is succeeding or languishing. Some question the rate at which progress is being made, including journalists who also cover Taiwan's computer and IT industries with their breakneck development speed and make the inevitable comparisons. On the other hand, there are policy makers and industry promoters who cheer at the slightest milestone obtained, however early-stage. As such, it's hard to gauge the true state of the industry. It is not helped by the fact that in Taiwan the very definition of the industry incites confusion. The so-called "biotechnology industry" is defined by the government as including the pharmaceutical sector, the medical devices sector, as well as the "emerging" biotechnology sector. Chinese herbal medicine, nutraceuticals, and cosmetics are considered biotech as well. Another difficulty, at least from an overseas perspective, are the many (and overlapping) industry contact windows, industry promotion bodies, government and quasi-governmental agencies, many with seemingly similar roles and responsibilities. For local companies, it is difficult enough to understand who is responsible for what, but for overseas companies looking for information, collaboration advice or assistance, it can truly be daunting. But despite these hurdles, it appears the industry is making steady progress.   Pharma Taiwan's pharmaceutical sector can be divided into three sub-sectors: generic drug makers, API manufacturers and contract biopharmaceutical manufacturers. Unfortunately, the generic drug companies are firmly stuck in "sunset industry" mode. Too small and inefficient to compete on an international level with global generics giants like Teva or Dr Reddy's, and with their profits squeezed by powerful hospital purchasing departments, the many hundreds of generics manufacturers operating in Taiwan don't have much of a future. As it is, nine of the top 10 pharmaceutical firms by revenue in Taiwan last year were foreign. Even in a market dominated by generics, local companies find it hard to compete with Big Pharma and their well-drilled sales teams. Exports remain both small in real and total percentage terms; figures that would be smaller still if it weren't for Wyeth skewing the numbers with exports from its Taiwan-based logistics center to Southeast Asia and Australia. To remain competitive, some of the larger generics companies are diversifying: China Chemical and Pharmaceutical Corporation (CCPC) with its API subsidiary China Chemical Synthesis Biotech Company; Yung Shin Pharmaceutical with its subsidiary Yung Zip, also an API maker; and the drugmakers Standard Chemical and Sinphar Pharmaceutical, both making inroads into consumer health and nutraceuticals markets. For API manufacturers, the flagship for the sector and a model for government investment and support of local start-ups, is ScinoPharm Taiwan. According to its CEO, Dr Jo Shen, the company supplies API to many top 10 Big Pharma, and even manages to supply its product to Indian generic drugs giants-quite a feat considering the competitiveness and cost pressure of the industry in India. The emerging contract manufacturing sector, particularly in biopharmaceuticals, is dominated by the government-funded research institute and industry promotion unit, the Development Center for Biotechnology (DCB). With its new cGMP and FDA-approved facility boasting of bioreactors in its manufacturing plant of 100, 300 and 500 liters, the facility complements the DCB's existing biotech and pharmaceutical industry services, including a contract laboratory facility and ALAAC-certified toxicology center. Along with the DCB in this industry space is Mycenax Biotech, also boasting of FDA-approved biopharmaceutical manufacturing facilities, as well as UBI Asia, and Advanced Gene Technology, to name a few.   Medtech In medical devices and technology, Taiwan believes it has all the pieces in place to be a major global player in the sector. It is easy to understand when one looks at what first made Taiwan a global powerhouse in the IT sector-its expertise in precision manufacturing, miniaturization, electronic circuitry design and engineering, and efficiency and innovation in the manufacturing process itself-all are transferable to the medical technology industry, be it in innovation, design or manufacturing. The local medical devices industry has been growing in double-digits in recent years; $1.6 billion in revenues were posted in 2004, with revenues expected to reach $6 billion by 2011. In fact, the medical devices sector is already the best performing of Taiwan's life sciences sectors, far exceeding pharma and emerging biotech. For local venture capital firms used to quick returns from investment in the IT sector, the idea of investing in medical devices companies with their relatively short lab-to-market timelines makes more sense than a similar investment into drug discovery companies. And with the latest devices offering health solutions that in the past only surgery or pharmaceuticals could deliver, medical devices-particularly implantables-are changing the very landscape of medicine. And this isn't limited to cardiovascular disease, where drug-eluting stents are being almost mainstream; there are now devices solutions for strokes, diabetes, and epilepsy. While such high-end devices are still mainly being developed and manufactured in western countries, Taiwan (and to a growing extent, China) is playing an increasing role in the global supply chain for the industry. For the world hospital consumables market, there are a host of Taiwanese companies succeeding in the safety syringe, IV set, and protective gear product sectors. With the home diagnostics market booming worldwide due to the rising cost of hospital care, companies in this space are growing along with it. Such companies include Rossmax International, a leading provider of OEM blood pressure monitors; Apex Biotechnology, a blood glucose monitor manufacturer; and Microlife, producing digital thermometers. In addition, a new class of companies are developing novel products with cutting-edge technologies. These include DailyCare BioMedical with its pocket-sized ECG machine, and Formosa Biomedical, with a device to measure arterial hardness, a marker for cardiovascular health. With Taiwan's LCD display industry leading the world in sales and innovations, it was only a matter of time before medtech and display technologies got together. The first success from this convergence has been New Medical Co., with its Digital Direct Radiography (DDR)-in other words, film-less X-ray imaging systems for the detection of lung and breast cancers, systems that are both cost effective and efficient from a hospital management perspective. The driving force behind medical technologies in Taiwan is the Industrial Technology Research Institute (ITRI). ITRI is the island's premier applied research facility, with over 7,000 scientists stationed at its impressive facilities an hour south of Taipei. With its Biomedical Engineering Center (BMEC) split into two at the beginning of the year, ITRI now holds the Biomedical Engineering Research Laboratories (BEL), and the Medical Electronics and Device Technology Center (MED). BEL is a multidisciplinary R&D and commercialization unit drawing from fields such as biology, chemistry, optics and micromachining. MED on the other hand focuses solely on the development of homecare medical devices. Being pioneers in the company spin-off process (the world's largest contract computer chip manufacturer, Taiwan Semiconductor Manufacturing Company, or TSMC, was an early ITRI spin-off), ITRI spinoffs in the life sciences include Phalanx Biotechnology, a biochip manufacturer; and DailyCare BioMedical. ITRI also has a very successful business incubation center, where many companies not only in medical technology but high-tech as a whole have been nurtured from start-up into successful ventures.   Biotech So-called "emerging biotechnology" has been making steady progress, albeit slower than original government and industry expectations. With the amount of money already spent on infrastructure development-including biotech science parks, genomics research centers, so-called "National Research Programs" in biotechnology and pharmaceuticals, genomic medicine, and agricultural biotechnology, Taiwan is now expecting to begin to reap the benefits. Once again the pieces are all in place: around 8,000 graduates in biological sciences every year, the recent return in large numbers of previously overseas-based renowned scientists and successful biotech entrepreneurs, generous incentive programs including tax holidays, interest-free loans, and matching grants, an impressive range of world-class research facilities and university biotech laboratories, a vibrant venture capital community, and so on. However, be it in innovation or in license deals, the extent of success in drug discovery and development has been a little disappointing. Reasons: Most companies are too small, and have subsequent funding issues; management inexperience, with many companies still run by their founding scientists; language and cultural barriers; technology transfer and technology valuation inexperience, meaning innovations tend to stall rather than be taken up by a licensee; and immature and inexperienced local regulatory bodies, leading to bottlenecks in the development process. It could also be argued that the innovation that biotechnology success depends upon is not being nurtured or encouraged to the same extent as it would be in the West. Or it could just be a perception problem; the long development times, typical in biotechnology test the patience of a population (and the investment community) used to fast change and quick results. Subsequently, there has been a new focus on behalf of the government for Taiwan to develop its biotech service sector, pushing its advantages as a drug development center for Western biotech firms, a cost-effective bioproduct manufacturing location, and a clinical trials center for the Asian region. In the meantime, companies in the drug discovery industry space are quietly making progress, and in the last few years at least the efforts are increasingly bearing fruit. For example, last year AbGenomics licensed its AB168 antibody (for autoimmune diseases, MS, psoriasis, and rheumatoid arthritis) to German drugmaker Boehringer Ingelheim; and Panion & BF Biotech, licensed its drug Zerenex (end-stage renal disease treatment) to US-based Keryx Biopharmaceuticals. US FDA IND approval was given to Medigreen for its asthma drug 1217B, while the DCB had several drugs in early-stage clinical trials overseas. The challenge for drug discovery and development companies worldwide is solving inevitable cash flow problems, and in Taiwan many such companies have branched into the health food market as a solution. For example, cancer-drug developer PharmaEssentia has turned to manufacturing CoQ10, a food and cosmetics additive, becoming in the process the world's fourth largest manufacturer and the biggest outside Japan. As many of Taiwan's drug discovery companies use herbal medicine as the source of their drug candidates, naturally the health food and consumer-level herbal medicine business is an effective means to bring in cash in the short term. Such companies using this approach include SunTen Phytotech, Sagittarius Life Science, Golden Biotechnology, and Medigreen. Taiwan has a large number of biotech companies working outside drug development and discovery as well; for example, in agricultural biotechnology in areas such as animal cloning and genetic modification being world-class. Innovations have also been made in new drug delivery technologies, novel DNA applications, stem cell research and applications, and biomaterials. While biotechnology in Taiwan gotten off to a slow start, achievements are now coming and at a faster pace than ever before. With the exception of a languishing pharmaceutical sector, there are encouraging signs for the future.   David Silver, Taipei (David Silver edits BiotechEast.com, a life sciences portal focused on the industry in Taiwan.)   ]]> <![CDATA["The potential for biotechnology businesses in India is enormous"]]> https://biospectrumindia.com/news/95/2137/the-potential-for-biotechnology-businesses-in-india-is-enormous.html https://biospectrumindia.com/news/95/2137/the-potential-for-biotechnology-businesses-in-india-is-enormous.html Mon, 11 Sep 2006 14:37:00 +0530 New Page 1 "The potential for biotechnology businesses in India is enormous" Dr Chandra Mittal, Professor of Biotechnology and Associate Chair, Houston Community College, Houston Dr Chandra Mittal has spent about 22 years in the American biomedical academia. This NRI scientist has also been deeply associated with the Indian biomedical arena. Dr Mittal has recently set up a novel advisory service-Indus bioAlliance for Indian entrepreneurs and investors in the biotech field. This non-profit organization will provide consultation to the existing and aspiring biotechnology entrepreneurs in India. In an exclusive interview, he unveils his future plans. How did the idea of introducing a biotech service to the existing businesses and aspiring investors and entrepreneurs in India take shape? The idea of introducing a biotech service to existing businesses and aspiring investor and entrepreneur had been evolving over the years. After spending 22 years in American biomedical academia, I launched a transnational biotech business in 1996 in the area of diagnostic biotechnology. While technically this area was close to my previous professional experience, the business exposed me directly to the non-technical challenges of small businesses in the high-tech area. The business venture also brought me to India many times where I was regularly approached by aspiring entrepreneurs, potential investors, and businessmen wanting to get into biotech business. They all expressed their desire to know and understand biotechnology business. One time, I was even engaged by the well-known business house, Hero Honda Group, for the same purpose. This experience conveyed to me that there is a void in India, which is limiting the growth of biotech entrepreneurship. I am very motivated to help Indian bio-entrepreneurs and contribute towards the development of biotechnology businesses. This is further bolstered by my involvement with the Community College-based biotechnology program in the US, which has given me an intimate look into the integrated development of biotech businesses. This is highly pertinent and useful for India. How big is the potential in India in this sector? The potential for biotechnology businesses in India is enormous as published by government agencies and business organizations. Furthermore, with high-tech businesses going global and geographic barriers coming down, Indian entrepreneurs and small businesses can realize the potential worldwide. The key for success is to find the right "niche" for a service or the product in demand. Since biotechnology businesses fall under multiple sectors, there is good scope for innovativeness. Each discipline and each innovation represents a new business opportunity. Furthermore, there are many businesses with good cash reserves ready for investment in biotechnology-based businesses. How will these services be structured? Will these be only advisory in nature or also provide seed funding? The exact nature of services will vary depending on the needs of the entrepreneur. These will be structured along the lines of organizational functions such as business planning, workforce training, R&D, technical-problem solving as well as the management of the bio-enterprise. The services will be provided by a panel of established and internally recognized experts in the field. The service will not directly provide any seed funding to the entrepreneur/business but it will help them raise funds from national and international sources. The salient features of the biotech business services will be the customized nature as well as on-site and off-site availability. There will be complete confidentiality, timely delivery, commitment for sustained involvement till business take off, opportunities for global collaborations, and innovative terms of payment that do not burden the entrepreneur at the beginning of the business activity. What are the important sectors within the biotech arena that these service will address? The services proposed will be applicable to three principal sectors within the biotechnology arena, These are health, energy, and agriculture sectors. Because the goal of the services is to promote overall bio-entrepreneurship in India, these will focus on all aspects of biotech business. There are many aspiring investors in India with very high success rates in the traditional businesses. But they have no clue about the business models in life science technologies. One such successful person confessed to me that he did not know how to "put his hands around" a biotechnology-based business. How are biotechnology-based businesses different from the traditional businesses and what are the challenges to be met for the success and expansion of bio-businesses in India? Biotechnology-based businesses are highly knowledge-intensive with great deal of dynamism and intellectual contents. This aspect is understandably difficult for the entrepreneur but it requires an appreciation by the investors. Although India has implemented the WTO regime in 2005, because of the traditional practices many investors do not take this aspect seriously. But this is one of the major stumbling blocks in building new bio-businesses in India, especially with foreign collaborations. Many biotech companies are hesitant to get involved in India for the fear of Intellectual Property Right violations. Another unique feature of biotechnology-based businesses is the requirement of multi-specialty expertise, which no one individual can provide. This necessitates the constant engagement of various independent business entities (contractors) to work together in harmony, based on trust and ethic, and honor the commitments made to each other. Unfortunately, there are many examples of business collaborations in India where parties have not honored the terms of business agreements. The challenges of biotech businesses require strong and credible legal system that can respond to the needs of bio-entrepreneurs and protect the interests of the investors. When will the service be launched? Who will primarily constitute your target audience? Some of the services are available right now and can be availed by the entrepreneurs in the form of consultancy. However, the full spectrum of services is expected to be launched towards late 2006. The primary target audience for these services will include professional investors, ambitious young entrepreneurs, and businesses looking for diversification. What is your long-term vision in this area? At present, the biotechnology industry is in its infancy. With constant basic biological research and resultant technological innovations, the biotechnology industry will conceivably grow for a long time. Just as an example, with the sequencing of human genome about 30,000-40,000 new molecular targets have been identified for new drug discoveries and diagnostics. Furthermore, better understanding of proteomic interactions, and nanotechnology is leading the way for new cures for diseases, manufacturing of bio-molecules, and bio-defense. The proposed services would play a positive role for the development of bio-businesses in India. Since you are based in the US, how would you go about making this service available to the Indian customers? Proposed services will be provided by a non-profit organization, Indus bioAlliance (an entity under Herichson Foundation for Health & Education, India) with offices in Delhi and the US. The services will be in the form of either online consultations or on-site visits or a combination thereof. All the corporate workforce training and problem-solving consultations will be provided on-site in India. Hands-on workshops in specialized biotechnology segments will be organized in large metropolitan cities for the benefit of industry in the adjoining areas. Prospective entrepreneurs and investors can contact us at: Indus.bioalliance@yahoo.com. Rolly Dureha     ]]> <![CDATA["Our goal is to make TCGLS Asia's largest CRO"]]> https://biospectrumindia.com/news/95/6010/our-goal-is-to-make-tcgls-asias-largest-cro.html https://biospectrumindia.com/news/95/6010/our-goal-is-to-make-tcgls-asias-largest-cro.html Mon, 11 Sep 2006 14:36:00 +0530 New Page 1 "Our goal is to make TCGLS Asia's largest CRO" Swapan Bhattacharya, director and head, TCG Lifesciences Kolkata-based TCG Lifesciences (TCGLS) is a comprehensive R&D services provider to the pharma and biotech companies in the drug discovery and development domain. A project of the US-based investment entity, The Chatterjee Group (TCG), it has made four distinct forays into research services. In a freewheeling interview, Swapan Bhattacharya, director and head, TCG Lifesciences, talks about the various services offered by its business entities. What is the aim and focus of TCG Lifesciences? Our goal is to make TCG Lifesciences Asia's largest CRO with the best scientific minds and simultaneously create value for our shareholders, employees and the community. Keeping in line with this objective, we at TCG Lifesciences constantly focus on partnering with various pharma and biotech companies, with the aim to provide a wide range of services through our integrated service platform/engine. This in turn helps us build strong strategic partnerships and gives us a competitive advantage over the existing players in this domain. How successful has TCGLS been in its various forays-synthesis of new chemical entities (Chembiotek Research International), bioinformatics (SilicoGene Informatics) and clinical trials (ClinInvent Research) and genomic (TCGA)? The proof of our success lies in the fact that we have 15 of the top 20 global pharma companies as our clients to whom we provide a wide range of customized and high-end integrated services in clinical research, library synthesis, molecular modeling computational sciences and life sciences informatics. Chembiotek has been expanding at a fast pace and has achieved several milestones since its inception. The changing dynamics of the pharma and biotech industries and an expanding client base have given rise to a compelling need to enhance our scientific strength. To meet this need and to increase our footprint across the country, Chembiotek has commenced operations from our second state-of-the-art facility at the International Biotech Park at Pune. How is the partnership between TCGLS and the different national labs shaping up? We are aware that industry-wide collaborative efforts are needed to build the necessary research infrastructure in India by specifically addressing chokepoints in the discovery value chain. The Centre for Genomic Applications (TCGA) is one such initiative in this direction. TCGA , a collaboration between the Institute of Genomics and Integrative Biology (IGIB), Council of Scientific and Industrial Research (CSIR) research institute, and The Chatterjee Group (TCG) is anchored on the public-private partnerships model, with an aim to cut down the research time and cost in the area of genomics and proteomics. The core shared facility at TCGA provides sophisticated equipment, as well as the related essential technical services to the research community that individual companies and entrepreneurs might otherwise be unable to gain access. The cost savings from replacing operations distributed across multiple sites with a single, highly focused core shared facility are substantial. TCGA also offers the opportunity and the environment for investigators with varied backgrounds and interests to interface and develop collaborations based on their common use of a particular technology. So far, TCGA has undertaken projects from research institutes like IGIB, CDRI, CCMB and IMTECH. It is now evolving as a well-equipped facility for high-end biology research and is also offering its research facilities to all other R&D institutes on a fee-for-service basis. Along with the Indian Statistical Institute, Centre for Population Genomics, TCGA is also building genetic-epidemiological research capacity in India. Their research-training project focuses on genetic epidemiology and ethical conduct of human genetics research in India, with particular emphasis on statistical and computational and molecular genomics. TCGA is also working with the Institute of Human Behavior and Allied Sciences (IHBAS) on a pharmacogenomics project for anti-epileptic drugs. TCGA has not only enhanced optimization by centralizing resources but has also helped organizations and institutions in overcoming the infrastructure speed breakers, which are significant barriers to the creation of internal industrial-scale facilities. What is the USP of TCGLS? Some of the key distinguishing features of TCG Lifesciences include: Integrated services platform across discovery and development space: TCGLS has built capabilities across key segments of drug discovery and development cycle. The integrated platform of capabilities enables it to partner large pharma and biotech companies in their search for new drugs with an array of capabilities unmatched by other contract research organizations. All operations are managed by independent teams to ensure that capabilities in the specific domains are tested against the best in the market and are constantly upgraded.   Scientific skills remain the main strength: TCG Lifesciences has engaged teams of high caliber scientists and set up world-class infrastructure to participate in post genomic life sciences research. The number of PhD scientists, including those with experience in the US and Europe, employed by TCGLS is significantly higher than any comparable CRO in India. The scientific leadership team comprises professionals with excellent track record of leading successful research programs and collaborations at the highest level in their specific domains.   Strong advisory board: An Advisory Board, comprising eminent scientists, business strategists and investment experts internationally recognized in their fields of expertise, actively supports TCG Lifesciences. The advisory board members participate in providing strategic direction, syndicating contracts for TCG Lifesciences and in providing scientific and technology inputs to the scientists. The constitution of the board reflects: Expertise in drug discovery and development, which aligns with the group's service offerings Extensive network of relationships with leading pharma and biotech companies Eminent academic scientists, providing access to current and emerging technologies Relationships with venture capitalists and private equity investors that ensure constant updation of emerging investment trends and opportunities. How do you see the services sector in this arena growing? The markets for targeted, customized therapies promises to grow. In addition, some of these therapies might sidestep current medical silos to cut across disease categories and physician specialties. This shift will call for a new paradigm across the innovation chain-from development through clinical testing and commercialization. In the new landscape, nimble companies with diverse capabilities are likely to outdistance monolithic ones. In this scenario, outsourcing (services) companies in assisting the pharma industry will have to seek ways of adding value to pharmaceutical companies. In this arduous task, the value chain model will help the outsourcing and services companies in analyzing specific activities through which firms can maintain value and have competitive advantage. In view of the fact that every phase of the value chain model requires the development of specific skills, added value technology, expertise, regulatory knowledge and know-how, outsourcing services companies are evolving into different forms (Contract Distribution Organizations (CDOs), Contract Research Organizations (CROs) and Contract Manufacturing Organizations (CMOs) to efficiently supply the pharma industry and to differentiate themselves from the competition. The purpose of the service model will be to prove to be an indispensable partner through reliability and a comprehensive range of services. We have already begun to witness a paradigm shift with respect to partnering models, which are evolving, from the plain vanilla transactional relationships to more strategic partnerships. Rolly Dureha     ]]> <![CDATA["Cost-effectiveness is our biggest competitive advantage"]]> https://biospectrumindia.com/news/95/1308/cost-effectiveness-is-our-biggest-competitive-advantage.html https://biospectrumindia.com/news/95/1308/cost-effectiveness-is-our-biggest-competitive-advantage.html Mon, 11 Sep 2006 14:34:00 +0530 New Page 1 "Cost-effectiveness is our biggest competitive advantage" Vivek Trikha, head-Diagnostics, OncQuest How did OncQuest come into being? A division of Dabur Pharma had been operating as one of the specialized sections of one of the biggest cancer hospitals in Delhi. At one point in time, we decided to come out of it and start offering our technology to patients all over the country rather than be hospital-specific. This was the key driving force to move out and OncQuest began its operations in 2003. Why did you choose to operate in the oncology segment? From the onset, we were very clear about the space in which we wanted to offer our services. We decided to operate only in oncology diagnostics despite having equipment which can be used for infectious diseases and endocrine diseases. This decision was basically taken keeping in mind the needs of oncology issues which are very different from other disease-related issues. Patient management is a continuous process in oncology. There's a lot of inflow of information between the clinician and the pathology lab, which is where we wanted to make a niche for ourselves. We have received a lot of respect and acknowledgement for the kind of work that we've been doing in this field. Who are your customers and what are the services you offer? Our customers are primarily oncology hospitals, nursing homes and CROs and our tests are prescription based. We offer a wide variety of cancer testing services. Our laboratory tests can help the oncologists answer specific questions about a patient's cancer. The laboratory utilizes the experience and expertise of trained scientists and physicians to provide clinicians with an incisive diagnosis and prognosis (monitoring) to identify disease and provide monitoring solutions at the fine point of differentiation of a disease. Batteries of molecular tests are performed, that helps the oncologist answer specific questions such as: Is the tumour malignant? What is the type of cancer ? How aggressive is the cancer? Is it likely to recur? OncQuest has introduced a number of techniques to evaluate the structure of DNA, RNA or proteins in cells. The most common methods used in the clinical setting include Polymerase Chain Reaction (PCR), real time PCR, fluorescent in-situ- hybridization (FISH), cytogenetics, flow cytometry, immunohistochemistry and routine surgical pathology. A number of these different methodologies can be used to detect the same abnormality. The selection of one technique over another is often based on a variety of factors, such as sensitivity and specificity profiles, cost, turnaround time and availability of technologically advanced and competitively priced laboratory set up. Are you servicing hospitals abroad or are there any issues? There are no major issues as such. But there are issues with regards to country-specific licensing and accreditation, which we have to tide over. We have started working on it and we would certainly look at catering to international markets. We have introduced an exclusive molecular testing facility in the area of diagnostic oncology for the first time in South East Asia and we are looking at expanding our reach toward neighboring countries in the months to come. The specimens from neighboring countries should start coming within six months to one year. And we are expecting an accreditation from the National Accreditation Board for Testing and Calibration Laboratories (NABL) for our testing facility soon. What is your USP? The concept of oncology diagnostic lab is relatively new in India. And OncQuest is a trend-setter in this segment. We have a wing of Dabur Research Foundation working with us and the team is constantly in the endeavor of finding newer assays or more cost-effective assays than what is commercially available in the form of a kit. We have been able to indigenously make world class quality reagents to support being very cost-effective for the patients. So cost-effectiveness is our biggest competitive advantage. We must have carried out about 10,000 tests that have been prescribed by over 2,500 doctors and our charges ranges between Rs 200 and Rs 20,000, which are significantly cheaper than the fee charged by laboratories in the developed countries. What makes you different? We are a little different than the other diagnostic centers. In the sense that we are very city-specific. We work on a model by which we have our outsourced logistics agents, who do our logistics work, collect specimens either from the hospital or from the doctor's clinic or from the patient's house and send it across to us in Delhi. Our logistics company in Bangalore is Medybiz. All service-related nitty gritties are taken care of and we work clearly in terms of prescription generation unlike direct-to-patients, which happens in routine tests. We cover about 30 locations in India which include all the metros and also semi-urban towns like Ludhiana, Lucknow, Jaipur, Mangalore and Panaji. N Suresh with Namratha Jagtap ]]> <![CDATA[India eyes new generation vaccines]]> https://biospectrumindia.com/news/95/2660/india-eyes-new-generation-vaccines.html https://biospectrumindia.com/news/95/2660/india-eyes-new-generation-vaccines.html Mon, 11 Sep 2006 14:33:00 +0530 India eyes new generation vaccines India eyes new generation vaccines Indian manufacturers are now looking at newer vaccines to bolster their margins and revenues. The Indian vaccine industry struggling with market satu- ration, price erosions leading to shrinking profit margins in the recent years has witnessed a spurt with emergence of new vaccines like HIV, rotavirus, malaria, tuberculosis and human papilloma virus. This has been fueled with consistent and dedicated interests from the Government of India and erstwhile organizations like the WHO, GAVI (Global Alliance for Vaccines & Immunization), UNICEF, Indo-US Vaccine Action Program and others. These organizations have recognized players from India like the Serum Institute of India, Panacea Biotec, Shantha Biotechnics and Chiron as pre-qualified vaccine manufacturers and procure vaccines from them at competitive prices. Besides Bharat Biotech International, Biological E and Cadila Pharmaceuticals are doing research in developing new vaccines in collaboration with national and international organizations. However, Utkarsh Palnitkar, director, life sciences, Ernst & Young India has pointed out that unlike most of the biopharmaceutical markets, vaccines possess certain distinct facets which enhance India's competitiveness. These include the presence of large institutional buyers, the generics-driven nature of the market and relatively lesser interest from large multinational players, who are increasingly focusing on developing blockbuster drugs. Dr Jayashree Mapari, senior research analyst with healthcare team, Frost & Sullivan India, said, " In India new generation vaccines are being developed in close cooperation with premier research institutes like the National Institute of Cholera & Enteric Diseases, Kolkata, National Institute of Immunology, Jawaharlal Nehru University and All India Institute of Medical Sciences, all in New Delhi, Central Drug Research Institute, Lucknow, Institute of Microbial Technology, Chandigarh, Indian Institute of Science Bangalore, Center for DNA Fingerprinting & Diagnostics Hyderabad, National AIDS Research Institute, and National Institute of Virology, both at Pune." Bharat Biotech International Ltd has partnered with US-based Novavax to develop avian influenza vaccine for India and other developing countries from South East Asia. This initiative is in close conjunction with the Department of Biotechnology (DBT) and will therefore be a significant step in the public-private partnership development in public interest. Serum Institute of India Ltd supplies vaccines to over 137 countries across the world and has been partnering with Chiron for development of a meningitis vaccine. It also has a tie-up with Gates Foundation and PATH for accessing testing technology at international level for developing pneumococcal vaccine. In the case of aersol measles vaccine for improved vaccine delivery system, Serum Institute is working with ICMR and WHO. It has also entered into partnership with John Hopkins, ICMR for Hib vaccine development. Indian Immunologicals is collaborating with the Indian Institute of Science to develop a DNA vaccine for rabies. Shantha Biotechnics is developing a cholera and typhoid vaccines in cooperation with International Vaccine Institute of Korea, and rotavirus in conjunction with NIH. Shantha is also planning a vaccine for rotavirus and varicella zoster. R&D scenario Some institutes in India along with the industry are trying to develop vaccines against TB, HIV and rotaviral diarrhoea. These efforts are still in the initial stages. Dr PK Ghosh, president, Cadila Pharmaceuticals Ltd said, "The use of Mycobacterium w is being explored by us to find its utility in tuberculosis for reducing sputum conversion period substantially as a therapeutic vaccine, when this is used in conjunction with the regular anti-tubercular chemotherapy. This project holds great hope for success. We also have approaches for developing therapeutic HIV vaccine, but the efforts are still at the preliminary stages. Our company in collaboration with the government and certain other institutes, proposes to spend a substantial sum during the next one decade. I am not quite sure if we shall be able to see successful Indian developments in the form of marketed vaccines against malaria during the next decade." Speaking about the R&D efforts being carried out at Shantha Biotechnics, Varaprasad Reddy, managing director, Shantha Biotechnics, said, "Our investment into R&D is 25 percent of our annual turnover till date since our inception in 1993. We have spent Rs 87 crore in R&D. This is nearly 33 percent of cumulative turnover that we achieved in the last nine years of our commercial existence. Shantha's investments into R&D are probably the highest in the country as the national average in the country is 0.5 percent of its turnover. Among all the biotech companies, Shantha has the largest R&D facility of world class and around 103 people are working in the R&D lab." "We believe in doing research in the field of medical sciences and in natural and applied sciences. There is no need to reinvent the wheel. Developing a vaccine will cost anywhere around Rs 30â€“40 crore excluding the cost involved in doing the basic research. We have been investing about 7â€“10 percent of our total sales turnover. It includes training and upgrading of the infrastructure. There are about 70 scientists working at the Serum Institute including a few scientists who have worked in MNCs abroad. We are looking at increasing our scientific team," said Dr SV Kapre, executive director, Serum Institute of India Ltd. Sharing similar views, KV Balasubramaniam, managing director, Indian Immunologicals Ltd said, "Investments have to be made both in good facilities and in developing talents of our researchers. Indian Immunologicals has an independent R&D center set up with an initial investment of Rs 15 crore with about 40 scientists working on modern immuno-biology covering recombinant products, plant cell derived products and monoclonal antibodies. We spend 5 percent of our sales on research and this is expected to significantly rise in the coming years." He further said, "Indian companies are now in various stages of launching conventional or combined vaccines, which are biosimilar. Most of these companies will be working on new generation vaccines only in the second phase. There is more science involved in the new generation vaccines such as DNA vaccines, peptide vaccines and edible vaccines. It also involves negotiating the patent thickets and actively seeking out select know-how licensing under the new IPR regime. This needs investments in basic research and higher level of knowledge from a more competent band of researchers. In my opinion, it will take at least five years before a new truly generation vaccine discovered by an Indian company is successfully commercialized. We expect our DNA rabies vaccine and plant cell derived vaccines to be in this list." Road blocks Although the vaccine industry in India is currently flooded with many companies developing newer vaccines, it might still prove an uphill task for India to establish itself as an innovator of vaccines. There are many factors that are coming in the progress of innovation of new generation vaccines from Indian companies like: lack of sufficient funds to support the R&D initiatives; lesser interests from companies to invest into R&D in comparison to commercial development, lack of coordinated efforts from the medical fraternity to support clinical trials; absence of central record/proper health record facilities dampening the efforts of the research community; uncertainties clouding the interests of MNCs with manufacturing bases in India for technology transfer to India and development of newer vaccines and lack of sufficient skilled manpower to support R&D for vaccine development are acting as bottlenecks. Narayan Kulkarni   ]]> <![CDATA[Vaccine development gains momentum]]> https://biospectrumindia.com/news/95/4153/vaccine-development-gains-momentum.html https://biospectrumindia.com/news/95/4153/vaccine-development-gains-momentum.html Mon, 11 Sep 2006 14:28:00 +0530 Vaccine development gains momentum Vaccine development gains momentum An update on the vaccines being developed in India. Rotaviral Diarrhoea Rotaviral diarrhoea vaccine specific to India enters Phase II trials Rotavirus is the most common cause of severe dehydrating diarrhea in infants and young children. In India two candidate vaccines 116E and I321 were developed under the Indo-US Vaccine Action Program. 116E was developed by the collaborative efforts of Dr MK Bhan, Dr Pratima Ray of All India Institute of Medical Sciences, New Delhi; Dr Nita Bhandari of Society for Applied Sciences, New Delhi and Dr Roger I Glass, Centre for Disease Control and Prevention, Atlanta, USA, while candidate vaccine I321 was jointly developed by Dr C Durga Rao of the Indian Institute of Science, Bangalore and Dr Harry Greenberg of Stanford Unviersity, USA. The phase I clinical trials dealing with the safety and immunogenicity studies have been completed in adults, children and infants. The infant trials showed both vaccines to be well tolerated and safe. Vaccine take was reported in 74 percent of recipients of 116E vaccine candidate and 40 percent recipients of I321 vaccine. Further the results revealed that the 116E-based vaccine candidate is more promising and provides up to 70 percent protection with single dose in infants, which may increase to complete protection with 2-3 doses. Now the vaccine based on 116E has entered phase II trials. Hyderabad-based Bharat Biotech International has produced prototype vaccine 116E under cGMP conditions to ensure its sufficient stock for the phase II and III clinical trials. Although the commercialization of the Rotavirus vaccine is still a few years away, it provides hope to combat one of the most serious public health problems affecting infants and children. Cholera First indigenous r-oral cholera vaccine completes phase I and II clinical trials Now an indigenous recombinant oral cholera vaccine has been developed in the country, which is based on VA 1.3 strain of V. cholerae. The vaccine has been jointly developed by Dr Amit Ghosh, ex-director, Institute of Microbial Technology, Chandigarh and Dr SK Bhattacharya, National Institute of Cholera and Enteric Diseases, Kolkata. The phase I and II clinical trials have been conducted in adults by Dr D Mahalanobis of Society of Applied Sciences, Kolkata and Dr Rakesh Agarwal of Sanjay Gandhi Post Graduate Institute of Medical Sciences, Lucknow. The results revealed that the vaccine is safe and the vibriocidal antibody response is equal to the best candidate vaccine available in international market. Out of 270 volunteers with 147 vacinees and 123 placebos, 48 percent had a four-fold rise or more and 40 percent had a eight-fold rise or more in Kolkata. The rise as marker of protection is comparable to the level raised with CVD 103 HgR in cholera endemic countries. Currently the preparations for the Phase III clinical trials are on. A field site for Phase III trial is being prepared for which survey and demographic patterns of more than 30,000 slum population has been completed and another 20,000 population is underway. Efforts are being made to transfer the technology and get the clinical grade material prepared for conducting the phase III trials. Rabies Animal vaccine slated for launch during 2006 after regulatory clearances The first combined DNA-based rabies vaccine for the control of rabies in dogs has been jointly developed by Prof. G Padmanaban, Emeritus Professor and distinguished biotechnologist and Prof PN Rangarajan of the Indian Institute of Science (IISc), Bangalore in collaboration with Dr VA Srinivasan of Indian Immunologicals, Hyderabad. Last year, studies were conducted at the IISc to analyze the residual DNA present in the germline doses of the vaccine. The PCR results indicated that that plasmid DNA was not detectable in the germline tissue of any inoculated animals. These results were submitted to the RCGM and GEAC, which gave the clearance for animal trials. The industrial partner, Indian Immunologicals, has prepared a batch of the combination rabies vaccine which has passed all the mandatory tests and conforms to the standards laid down by the Indian Veterinary Pharmacopoeia. The formulated vaccine is currently undergoing trials in Kerala. In future, clinical trials are also planned in Chennai, Mumbai, Bhubaneshwar and Delhi. The results of the trials will be submitted to the regulatory authorities. The study so far conducted clearly indicates that the combined DNA rabies vaccine provides tremendous boost to the inoculated animals. The animal vaccine is slated for launch this year after the necessary regulatory clearances. Subsequently the human trials will be undertaken in 2007. Typhoid New Vi-conjugate developed and technology transferred to industry Dr Ramesh Kumar and Dr BL Jailkhani of AIIMS, New Delhi developed Vi polysaccharide conjugate typhoid vaccine using Salmonella typhi outer membrane protein from conjugation. This Vi conjugate has been shown to be immunogenic in mice. The Typhoid Vi Vaccine is presently undergoing trials in Kolkata. Recently the Biotech Consortium India Limited (BCIL) entered into a License Agreement with USV Limited, a Mumbai-based biopharmaceutical company, to upscale, manufacture and market the novel conjugate typhoid vaccine Japanese Encephalitis Tissue culture based, inactivated Japanese Encephalitis vaccine developed at NII A tissue culture based and inactivated Japanese Encephalitis vaccine was developed by the team of Dr Sudhanshu Vrati at the National Institute of Immunology, New Delhi. The scientists had grown an Indian strain of Japanese Encephalitis Virus (JEV) in Vero cells to high titers and formalin inactivated it. Inactivated virus produced high titers of JEV neutralizing antibodies and challenge experiments in mice indicated that the preparation provided 100 percent protection to the immunized mice against lethal dose of JEV given intra-cerebrally. Further the technologies for high density culture of Vero cells using micro carriers in a spinner flask; high titer culture of an Indian strain of JEV in Vero cells and its formalin inactivation were standardized and transferred to New Delhi-based Panacea Biotec. Meanwhile, Panacea has also obtained Vero cells from the WHO and standardized JEV cultures. Now the company will soon initiate the preclinical toxicity trials and is planning to start the Phase I clinical trials subsequently. In another approach to evaluate the immunogenicity of the DNA JEV vaccines, Dr Vrati has developed a candidate DNA-based JEV vaccine (replication-defective recombinant adenoviruses). Rhesus monkeys have been immunized with the JEV DNA vaccine candidates and immune response of these plasmids is being studied. Leprosy A leprosy vaccine called "Immuvac" was developed at the National Institute of Immunology, New Delhi and the technology transferred to Cadila Pharmaceuticals, Ahmedabad. The product is also recognized as an orphan drug, which is available in the market. In a notable development, Mycobacterium W has shown its potential as therapeutic agents by reducing the chemotherapy duration in leprosy patients. Based on the results, a multi-centric project is being supported using a uniform clinical protocol involving several centres to study the safety and efficacy of Mw immunomodulator as adjunct to ATT therapy in all categories of pulmonary tuberculosis patients. The centres involved are: AIIMS, New Delhi; LRS Institute of TB and respiratory diseases, New Delhi; Central JALNA Institute for Leprosy, Agra; SMS Medical College, Jaipur; NHL Municipal Medical College, Ahmedabad; RNT Medical college, Udaipur; National Tuberculosis Centre, Bangalore and Tuberculosis Research Centre, Chennai. The trials are currently in progress. Malaria The International Centre for Genetic Engineering and Biotechnology (ICGEB) has been working on understanding the biology of the malaria parasite and developing novel therapeutic strategies against it. Recently, Dr VS Chauhan and Dr Chetan Chitnis at ICGEB, New Delhi were able to produce the recombinant candidate antigens of P. falciparum and P vivax under GLP conditions. Now the method of producing the recombinant antigen has been scaled up in collaboration with industrial partner, Hyderabad-based Bharat Biotech International Ltd (BBIL). The company has successfully produced three consistent batches of clinical grade material at 10L scale for preclinical toxicology studies under cGMP conditions. Currently the safety and phase I clinical trial studies are being planned, while the toxicity trials have started. The malaria vaccine trial site has been developed at Sundergarh district of Orissa to evaluate the malaria candidate vaccinogens through collection of clinical, entomological and molecular epidemiological/immunological indicators from the study. Tuberculosis Efforts have been made to develop novel recombinant DNA-based candidate vaccine and recombinant BCG containing relevant antigens of Mycobacterium tuberculosis by Dr Anil K Tyagi of Delhi University (South Campus), New Delhi. For developing novel candidate vaccines, his group has expressed six antigens of M. tuberculosis using different vectors in E. coli expression system. All the DNA candidate antigen were found to elicit specific immune responses in experimental animals. Testing in aerosol challenge models is in progress to select the best candidate for human studies. The group has also initiated work on the DNA vaccine approach for the development of candidate TB vaccine by using three M. tuberculosis antigens. These proteins have been cloned and expressed in E. coli. Simultaneously efforts are being made to express these in eukaryotic system. Antibodies have been raised against these three recombinant proteins in rabbits and their immunoreactivity is being studied. Dengue The existence of multiple but distinct dengue virus serotypes is a major factor that has hindered dengue vaccine development efforts. Available evidence indicates that immunity against an infecting serotype is life-long, whereas cross-protection against other serotypes is transient. Protection against only one or two dengue viruses could actually increase the risk of potentially fatal dengue haemorrhagic fever and dengue shock syndrome. Therefore, a safe and effective dengue vaccine should ideally be "tetravalent" or capable of providing solid and long-lasting immunity to all four serotypes. Taking this approach further, Dr Navin Khanna and his group at ICGEB are developing a tetravalent dengue vaccine candidate. The strategy is to make non-replicating sub-unit vaccine based on a critical domain of the major dengue structural envelope protein that is involved in the host receptor reception and in the induction of robust protective immunity. Each subunit is being expressed using Pichia pastoris as the expression host. HIV/AIDS HIV/AIDS continues to ravage many parts of the world. A DNA/MVA based vaccine has been developed by Dr Pradeep Seth, ex-professor and head, Department of Microbiology, AIIMS, New Delhi for HIV-1, subtype 'C' prevalent in India. The indigenous recombinant DNA/MVA vaccine is constructed from select genetic sequences of HIV and is delivered with the help of a plasmid vector in the prime dose and a highly attenuated strain of Vaccinia virus-Modified Vaccinia Ankara (MVA)-as the vector in the boost dose. The vaccine is currently poised for GMP production and preclinical toxicology studies. After successful completion for the preclinical studies, the clinical trials in human volunteers will be initiated after mandatory approval by the regulatory agencies. Anthrax Anthrax is a zoonotic disease caused by gram-positive sporulating bacteria bacillus anthracis. The recombinant protective antigen (rPA) against anthrax was developed by Dr Rakesh Bhatnagar of Jawaharlal Nehru University (JNU), New Delhi and the technology was transferred to New Delhi-based Panacea Biotec. The efficacy and immunogenicity of recombinant vaccine was tested in New Zealand white rabbits and Rhesus monkey by pre exposure and post exposure prophylactic studies. The phase I and phase II A trials have been completed, while the company is geared up for the Phase II B and Phase III trials. In addition, a protocol for experimental trials of recombinant anthrax vaccine in animals has also been developed. Human Papiloma Virus The Department of Biotechnology (DBT) has generated an end-to-end mission project on the development of vaccine candidates for Human Papilloma Virus. The efforts include: identifying oncogenic strains prevalent in different geographical regions of India, validating self-collection methods using cervical swabs, assessing molecular variations if any and development of indigenous test systems. The groups are also expressing L1/L2 proteins of HPV 16/18 as Virus Like Particles (VLPs) and Capsomere Like Particles (CLPs) as possible prophylactic vaccine candidates. It is also envisaged making chimaeric proteins using various combinations of L1/L2 and E6/E67 proteins in order to make therapeutic candidates. The target population in Indian social conditions would be HPV infected women. Hence it is relevant to make efforts in the direction of therapeutic vaccine candidates. FMD Vaccine The FMD is a highly contagious viral disease of cloven-hoofed animals and causes serious production losses. Recently Panacea Biotec collaborated with the National Research Development Corporation (NRDC) for in-licensing of technology to produce and market the Foot and Mouth Disease (FMD) vaccine developed by the Indian Veterinary Research Institute (IVRI). The NRDC will facilitate the transfer of know-how for the process of FMD vaccine manufacturing incorporating a new adjuvant developed by the IVRI, while Panacea will manufacture and market it in the country. The latest technology of the vaccine can replace the Ultra Filtration Method of virus concentration with an alternate technology. It can also replace the imported oil adjuvant with the indigenously developed oil adjuvant. The vaccine has been tested for toxicity (standard tests) and found to be safe. The vaccine is expected to be rolled in the market in the coming 18-24 months. Others R&D efforts are being initiated for several other vaccines such as recombinant DNA based vaccines for filarial, pneumococcal, bovine tuberculosis, brucellosis and duck plague. Rolly Dureha   ]]> <![CDATA[Biofunds, Still Elusive]]> https://biospectrumindia.com/news/95/2337/biofunds-still-elusive.html https://biospectrumindia.com/news/95/2337/biofunds-still-elusive.html Mon, 11 Sep 2006 14:18:00 +0530 Biofunds Biofunds, Still Elusive Though the biotech and life sciences industry in India is on a maturing trail, the funding still remains elusive. The government and venture capitalists are looking at building this sector. With an understanding of the positions of all the players involved, the sector can attract more investments. In May 2003, just two months after BioSpectrum was launched, we carried a report on the biotech financing scenario in India. The need of the hour then was Rs 200 crore to help the industry blossom. But the concern was where would the funds come from-through the government or the venture capital funds or the private equity? Each of the players involved-the government, the financiers, and the entrepreneurs-had their own view points. There is no doubt that a great deal of progress has been made on this front, though the scenario has not changed drastically. For a biotech start-up, the only sources of funds then were the Technology Development Board (TDB) in the Department of Science & Technology (DST), the New Millennium Indian Technology Leadership Initiative (NMITLI) of CSIR, and the SPREAD program of the ICICI Bank. However, the pool from where biotechs can source funds has grown. Today, biotechs can go to SIDBI, APIDC-VCL, GVFL, Pharmaceutical Research and Development Support Fund (PRDSF), The Small Business Innovation Research Initiative (SBIRI), and a host of VC and private equity funds. However, this does not indicate that a lot has changed in terms of investments into biotechs. "Money is not an issue provided the projects are good. It can be mobilized. There are many investors who are eager to invest in the biotechnology industry. The government has been doing a lot. It has taken up the issue. There are many funding initiatives such as the TDB, NIMITLI PRDSF, and SBIR. These schemes would try to bridge the gap of supply and demand of funds needed for research activities," reiterated Alok Gupta, country head, life sciences & biotechnology, Yes Bank Ltd. However, the understanding about the investment opportunities is yet to spread. "There is a growing awareness of the investment opportunities in the Indian biotech sector. But what is needed now is to create a deeper understanding of what these opportunities are," said Dr Kiran Mazumdar-Shaw, founder president of ABLE, and CMD Biocon. In addition to the government, the private sector VC funding too has been growing. "The life sciences industry is currently generating enormous interest among Private Equity (PE) firms with many leading investors making significant investment bets on companies in this sector," said Arun Natarajan, founder and CEO of Venture Intelligence, a leading provider of research and networking services to the Private Equity and Venture Capital ecosystem in India. According to a study by Venture Intelligence, private equity firms invested about $109 million across 10 firms during the six months ended June 2006. This compares to $179 million across 12 companies in 2005. Newer funding models are emerging too. Established pharma and biotech companies and diversified business houses are experimenting to expand their technology basket following the footsteps of their more mature peers in the developed economics. For example, the Tata Group has invested in a start-up drug discovery company, Advinus Therapeutics. Biocon acquired stakes in two US-based research companies-Nobex and Vaccinex. Zydus Cadila has entered onto a joint venture with the US-based Onconova Therapeutics, a biopharmaceutical company specializing in the field of oncology. Dr Reddy's Laboratories entered into an innovative financing structure for its drug pipeline by forming an integrated drug development company called Perlecan Pharma with equity commitments of $52.5 million from Citigroup Venture Capital and ICICI Venture Funds. "These are all very interesting models and this would encourage the private equity support to the biotech," pointed out Dr Kiran Mazumdar-Shaw. There is venture and corporate funding support to young biotech companies cutting across the various segments of biotechnology like bioinformatics (Ocimum Biosolutions and Molecular Connections), vaccines (Bharat Biotech), drug discovery (VLife Sciences Technologies, Advinus Therapeutics, and Perlecan Pharma), clinical research (Manipal AcuNova, Metropolis, and SIRO), biopharmaceuticals (Zenotech), bioagri (Metahelix), preventive healthcare (Avesthagen) and diagnostics (ReaMetrix) . "On the whole, the sector attracted over $125 million funding, a 150 percent growth over the previous year. On the business model front, inorganic international growth seems to be the new trend and Indian biotech sector is pro-actively repackaging itself from low-end research and manufacturing base to a value-added partner in the global marketplace. Biotech companies in India are seen to be increasingly focusing on high-end technologies, drug discovery and scalable products," pointed out Nitin Deshmukh, honorary director, ABLE and head-private equity, Kotak Mahindra Bank. He added, "Smaller biopharmaceutical companies which initially emulated the services model, are moving towards innovative research and drug discovery realizing that it is imperative to move towards a product driven model to attract VC funding and scale up growth. A similar transformation is happening with India's champion bioinformatics companies who are fast incorporating wet labs for a sustainable growth." Clinical research companies were the new entrants on the biotech landscape in 2005 and were seen to be mushrooming across the country. The business models of many of these companies were far from market realism though and needed strong support of business acumen and knowledgeable partnerships. The movement for creating the platform for deeper understanding of the opportunities in the area has begun. Events are being organized to facilitate this dialog between the investing community and the biotechs. While ABLE is organizing BioInvest 2006 in Mumbai on November 17-18, IVCJ held a conference on Private Equity and Life sciences with Focus on Biotechnology, Pharmaceuticals and Healthcare in August. "These conferences will help the VC community to understand the biotechnology sector better and will also increase the probability of more investments in biotechnology in the near future," noted Alok Gupta. The Indian biotech industry posted a very strong overall growth in 2005-06. The topline grew by 37.42 percent to record $1.45 billion (Rs 6,521 crore) in revenues. BioPharma and BioAgri continued to be the critical drivers contributing to this growth rate. Importantly, it is not just the growth in revenues but also the growth in terms of number of companies, alliances, product launches and stronger product pipelines that give the preview of things to come. VC and Private Equity Investments The Indian biotech sector is moving ahead on its evolutionary path and entering the preliminary stages of a long-term growth cycle. As the generics market gets more competitive, more players are in pursuit of biotech opportunities, which have now become an integral part of the pharma scene in India. This sector is receiving strong government support and is being nurtured by ambitious entrepreneurs and technocrats. But there were only two VC and PE deals in 2005 in biotechnology which is not sufficient to give the required boost to the biotechnology industry in the country, risk funding being pivotal to the growth of this industry. As risk associated with investments in this industry is high, private equity and venture capital, as a class of funding, is crucial to escalate the development of the Indian biotech sector in the same vein as it served as a catalyst for the biotech industries in Europe and the US. Equally, existing and aspiring entrepreneurs and technocrats need to seriously consider the risk capital route and bring forward well thought-out business strategies to the table of private equity and venture capital players for consideration. With timely indications of more enthusiasm from Venture Capitalists and Private Equity players, the Indian biotech industry has the potential to scale into a force to reckon with over the medium to long term. The paucity of VC and PE deals taking shape for biotech projects signifies a structural flaw in the flow of this type of capital towards the biotech industry in India. Some factors plaguing this sector are: lack of qualified employees, lack of understanding of this sector in support industries like IT and banking, weak IP laws and lack of world-class infrastructure. VCs are still cautious in committing resources for the biotech sector and mostly skewed towards late stage private equity deals. With investments in start-ups being few and meager and hardly any benchmark deals to aspire towards, young Indian companies are exploring alternative forms of alliances to enlarge their growth potential. There is a new interest from international quarters to fill the major vacuum in the biotech space. HBM partners, one of the world's largest biotech VC has allocated $20 million for India. International financial organizations, especially those under the umbrella of the IMF or World Bank, are inclining towards a new trend to encourage start-ups and early stage ventures in India, in varied fields of biotech, software and other high tech areas. The International Finance Corporation (IFC), a private sector arm of the World Bank Group, committed $4 million in equity to APIDC Biotechnology Fund, targeting early stage companies in life sciences. The IFC has committed to the APIDC Biology Fund, which in turn will make equity and equity-related investments in early-stage life-science businesses. The APIDC Biotechnology Fund is the first fund in the country to focus exclusively on the life sciences sector. Technology Development Board Technology Development Board Technology Development Board The Technology Development Board is the first organization of its kind within the government framework with the sole objective of translating the fruits of indigenous research into commercial products and services. The Board plays a proactive role by encouraging commercial enterprises to take up technology-driven projects. It offers soft loans to the enterprises, for commercializing innovative indigenous technologies and/or adapting imported technologies to Indian conditions. Dr H Purushotham, Advisor, TDB, shares a few details. What are the new life sciences projects that have been financed during this year? About 7-8 life sciences projects have been financed during the year. The projects financed include Trichoderma and Rhizobium fermentation-Haryana Biotech; Purified antigen vaccine for FMD in animals-Bangalore-based BioVet; Production of recombinant Hepatitis C viral antigens-Hyderabad-based Sudarshan Biotech; Pentavalent Vaccine (DTP+Hib+HepB)-Hyderabad-based Shantha Biotech; Biotech based oncology and endocrinology drug-Hyderabad-based Genotech Laboratories; Commercialization of enzymes-Hyderabad-based Celestial Labs; and Trace analysis laboratories in genome valley for contract research-Vimta Labs. Till date, how many life sciences projects have been successfully completed? Since the establishment of the TDB in 1997, about 17-18 projects have been completed. What is the limit of funding to these projects? The Board finances 50 percent of the project cost. Till date, the minimum funding towards any project has been Rs 40 lakh, while the maximum funding has been to the tune of Rs 10-12 crore. How many proposals does the TDB receive from life sciences/biotech companies in a year? The TDB receives about 14-15 projects in a year out of which five to six projects may be finally considered for funding.   GVFL announces first investment from GBVF GVFL Ltd has announced its first investment under its biotech fund. It is providing an early stage funding of Rs 2 crore to Ahmedabad-based Celestial Biologicals Ltd, which is promoted by the Intas Group. It is understood to be the first Indian company to source local (Indian) plasma, get it fractionated and market the derived products Albumin (brand name: ALBUCEL) and Immunoglobulins (brand name: GLOBUCEL) in India. With these funds, Celestial Biologicals plans to set up a state-of-the-art fractionation facility at Ahmedabad, to ensure self reliance of plasma proteins for the Indian market. "It will not only bring down the cost of plasma protein but also ensure safety and quality of these products. Worldwide, one million lives are saved through plasma therapeutics-Albumin, Immunoglobulins, Factor VIII, and Factor IX. These are all invaluable in the treatment of circulatory ailments, clotting deficiencies, and immunodeficiency. But thousands of Indians lose out, as our people are dependent on imports that are expensive and not readily available. Celestial Biologicals Ltd seeks to alleviate this situation and we see immense potential in this industry and the company," said Vishnu Varshney, CEO, GVFL Ltd. The Gujarat Biotech Venture Fund (GBVF) is a 12-year close-end fund with a target corpus of Rs 50 crore. With fund commitments from the government of Gujarat and Zydus Cadila and eminent industry experts like Dr KK Tripathy (Advisor, DBT) and Dr Harish Padh (Director, Pharmaceutical Education and Research Development) on the investment board, GBVF would identify and invest in start-ups, early stage and existing companies in the areas of biotechnology having the potential to become leading players in India. GVFL Ltd, formerly known as Gujarat Venture Finance Ltd, is widely regarded as the pioneer of venture capital in India. Started by the Gujarat Industrial and Investment Corporation (GIIC) at the initiative of the World Bank in July 1990, GVFL Ltd has raised five venture capital funds with a combined corpus of Rs 175.6 crore.   SBIRI The Small Business Innovation Research Initiative (SBIRI) is the new scheme launched by the Department of Biotechnology (DBT) to boost public-private-partnership effort in the country in 2005. The distinctive feature of SBIRI is that it supports the high-risk pre-proof-of-concept research and late stage development in small and medium companies led by innovators with science backgrounds. Area coverage: The scheme covers all areas in biotechnology related to healthcare, agriculture, industrial processes and environmental biotechnology, and biomedical devices and instruments. Eligibility: The proposals can be made solely by in-house R&D unit(s) of industrial firms; or jointly by industry and national R&D institutions; or collaborative projects of common interest to the concerned sector/area proposed by a group of industries/users and national research organizations. Funding structure: The SBIRI scheme will operate in two phases, i.e., for establishment of pre-proof of concepts of innovations and for product and process development. In both the phases, the projects will be implemented at the industry site. Current status: The first set of companies being funded under the SIBRI scheme have been shortlisted and the final agreements are being worked upon between the stakeholders, while the proposals for the second round of funding have been received and are currently under evaluation.   PRDSF During January 2004, the Indian government established the Pharmaceutical Research and Development Support Fund (PRDSF) and Drug Development Promotion Board (DDPB) under the Department of Science and Technology with an initial corpus of Rs 150 crore. Interest accrued on corpus is also utilized for supporting R&D projects jointly proposed by industry and academic institutions/laboratories and extend soft loan for R&D. For collaborative R&D projects, this fund supports research in all systems of medicines including setting up of facilities. It supports joint research projects of industry and institution. Normally a collaborative project entails 50:50 sharing of financial requirements between industry and institution. While the research undertaken by the industry is funded 100 percent by the industry, the institution share is supported jointly by the government and industry. The fund also provides soft loan for pharma industrial R&D projects. The maximum loan amounts up to 70 percent of the project cost. The repayment of the loan is expected in 10 annual equal installments after the project period Significant achievements: Some significant achievements under this scheme are that a peptide based anti-cancer drug for the treatment of colorectal cancer by Dabur Research Foundation is under Phase II of clinical trial. Six product patent applications based on three projects have been filed, while 12 process patent applications based on four projects have been filed.   NMITLI The New Millennium Indian Technology Leadership Initiative (NMITLI) is the largest R&D program to proactively boost the Public-Private-Partnership (PPP) within the country. NMITLI supports two categories of projects-Nationally Evolved Projects (NEP) and Industry Originated Projects (IOP). Financial support: During the last few years, less than five percent of the projects got qualified for development under this scheme. The financial support to all the projects under NMITLI program is in the form of grant-in-aid to the institutional partners in public domain and as soft loan at three percent interest to the industrial partners. The scheme was initiated in 2000 and during the past six years of its existence, the program has evolved 42 R&D projects covering diverse areas. These projects involve 287 partners (222 in the public sector and 65 in the private sector) with an estimated outlay of Rs 300 crore. The R&D areas covered are biotechnology, drugs and pharmaceuticals, chemicals, materials, information technology, bioinformatics, leather technology, energy, weather forecasting, etc. In the area of life sciences, at present there are 26 ongoing projects with a total budgetary outlay of Rs 150 crore. Selection Process: The building up of NEPs begins with wide ranging consultation to elicit ideas. For IOPs, the process begins by soliciting proposals from Indian industry through press advertisements and personal letters from the DG, CSIR.   APIDC-VCL A PIDC Venture Capital's "The Biotechnology Venture Fund" is India's only biotech focused venture fund. APIDC Venture Capital is one of a handful of fund managers that focus on early stage VC in India and has been working closely with research and technology institutions in India. APIDC-VC is looking to build global leaders from scratch, by backing both Indian and overseas entrepreneurs or companies with big ideas that leverage. BioServe Biotechnologies and Silico Insights (now Nuvera Biosciences) are some of the companies where APIDC -VCL has invested $5,40,000 each. Both these companies are based in the US. A few months ago, it invested in Evolva Biotech SA (Allschwil, Switzerland). In connection to the financing, Evolva formed a subsidiary in Hyderabad, India and will be building a molecular biology research operation in India, to be based in Hyderabad or Goa. Recently, International Finance Corporation, the private sector window of the World Bank, proposed to invest $500 million in India, a 25 percent rise from its exposure of $400 million last fiscal (July 2005 to June 2006). "The exposure of IFC in the South Asia last fiscal stood at $506 million, of which over $400 million was invested in India alone," said IFC South Asia Portfolio Manager Colin J Warren. The key sectors which IFC is investing include pharmaceuticals, infrastructure, auto components, IT and biotechnology. IFC sees great potential for biotech and pharmaceutical sectors in India's economy. IFC has invested in APIDC Biology Fund, which in turn will make equity and equity-related investments in emerging life science businesses. IFC has also invested in Bharat Biotec India Ltd.   Bioinvestor Meets Over the past few months, focused investor meets are being organized to understand the opportunities and scope in funding. Burrill & Company organized "The India Life Science Partnering Meeting" in Chicago in April 2006. In addition to this, there are three more conferences, which are being organized to bring in the awareness about the biotech industry among the VC/PF community in India. Life Sciences Connect: Venture Intelligence, the leading provider of research and networking services to the Private Equity and Venture Capital ecosystem in India organized "Life Sciences Connect", a conference on Private Equity investing in the Life Sciences sector. The event was held on August 29, 2006 at the ITC Hotel Kakatiya Sheraton & Towers, Hyderabad. The key themes of discussion were Tapping PE to fund New Drug Development, Opportunities in the CRO Space, the Payoffs and Pitfalls of raising PE Financing and the Role of Mergers & Acquisitions in Life Sciences. The event was targeted at executives from the Private Equity industry looking for investment opportunities in the life sciences sector. BioInvest 2006: ABLE, The Association of Biotechnology Led Enterprises, a national forum that represents the Indian biotechnology sector, is holding BioInvest 2006-an interactive conference for life sciences and investment firms in Mumbai on the November 17-18, 2006 at the Grand Hyatt. The objective of the conference is to bring together on one platform life science companies, institutional investors and investment bankers to explore opportunities for investments and partnering. IVCJ Conference on Private Equity & Lifesciences: Dickenson Intellinetics Pvt Ltd's Indian Venture Capital Journal (IVCJ) too is organizing a conference on life sciences and biotechnology and pharmaceuticals. IVCJ forum is a two-day conference that would be held on November 14-15, 2006 at ITC Grand Maratha Sheraton, Mumbai, and is aimed to serve as a platform for investors and industry players alike to discuss and plan their strategies around a totally new risk and returns milieu. IVCJ aims to bring out an absolute picture of the VC&PE activity taking place in all the three sections of lifesciences, namely pharmaceuticals, biotechnology and healthcare. It also aims to bring key decision makers from the of VC&PE and lifesciences industries to facilitate discussion on key issues and create a conducive networking environment. Ch.Srinivas Rao, Rolly Dureha and Narayan Kulkarni       ]]> <![CDATA[Dr Lalji Singh gets JC Bose Fellowship]]> https://biospectrumindia.com/news/95/2750/dr-lalji-singh-gets-jc-bose-fellowship.html https://biospectrumindia.com/news/95/2750/dr-lalji-singh-gets-jc-bose-fellowship.html Wed, 09 Aug 2006 15:04:00 +0530 Dr Lalji Singh gets JC Bose Fellowship Dr Lalji Singh gets JC Bose Fellowship Dr Lalji Singh, director, Centre for Cellular and Molecular Biology (CCMB), Hyderabad has been selected for the prestigious JC Bose National Fellowship. The JC Bose Fellowship was instituted to give a boost to scientific research in the country. The fellowship constituted by the Department of Science and Technology (DST), Government of India, recognizes active, performing scientists and engineers below the age of 60 years in the country for their outstanding performance and contributions. Dr Kannan appointed Nagaland varsity VC Dr Krishnamurthy Kannan, professor and founder dean, School of Biotechnology, Guru Gobind Singh Indraprastha University, New Delhi has been appointed the vice-chancellor of Nagaland Central University. This appointment has taken him by surprise as he had not applied for the post. It is most likely that someone had recommended his name. Commenting on this development, Dr Kannan said, "I am feeling very happy and looking forward to this position in Nagaland which is blessed with an extremely rich biodiversity." Sharing his future plans for the university, he said, "I will set up an engineering and management department along with a biotechnology department. The government has already allocated 400 acres of land for the expansion and resources will not be a constraint." Dr Kannan, who is planning to join in early August, added, "I also want to create a biotechnology park for entrepreneurs, which will be different from the conventional park set-ups." Dr Kannan is a trained protein chemist. He completed his Bachelor's degree from Delhi University in 1973 and his Masters in Chemistry from the Indian Institute of Technology (IIT), Mumbai, two years later. From 1970-79, he was the recipient of the National Science Talent Search Scholarship. He went on to complete a doctorate degree in biochemistry from the Central Food Technological Research Institute (CFTRI), Mysore, in 1979. Subsequently he went for higher studies in the Department of Biochemistry, Imperial College of Science and Technology, London. The professor has earlier worked with premier public as well as private sector institutions like the Centre for Cellular and Molecular Biology (CCMB) at Hyderabad and Ranbaxy Ltd. Rupinder Singh joins Kerry Bio-Science Rupinder Singh has joined Kerry Bio-Science as country sales manager- pharma and is looking after the Greater India territory. Kerry Bio-Science is one of the leaders in innovation and application of bio-and pharma-ingredients, serving pharmaceutical, savory, bakery, beverage, dairy and confectionery markets worldwide. The company has leading global positions in bio- and pharma-ingredients, including protein hydrolysates, emulsifiers, yeast, enzymes, hydrocolloids, cultures and fermentation products. Prior to this, Rupinder was with BD BioSciences, leading their reagents team as business manager. A gold medalist from Punjab University Chandigarh, he spent his initial years with Lupin labs and gained about six years of research experience in molecular biology and immunology. ]]> <![CDATA[Harvesting marine biotechnology]]> https://biospectrumindia.com/news/95/2265/harvesting-marine-biotechnology.html https://biospectrumindia.com/news/95/2265/harvesting-marine-biotechnology.html Wed, 09 Aug 2006 14:59:00 +0530 Harvesting marine biotechnology Harvesting marine biotechnology The DBT is likely to address several developmental issues in the sector of aquaculture and marine biotechnology through supporting projects in priority areas. The interest in marine sector has been growing in recent years globally. It is reported that less than 1 percent of the extant marine and terrestrial bacteria have been isolated and studied. Research in aquaculture and marine biotechnology is leading towards development of new and improved products from the seas and ocean through fundamental understanding of the genetic, nutritional, and environmental factors that control the production of primary and secondary metabolites, identify bioactive compounds, determine mechanisms of action and function of natural production system and provide models for new lines of selectively active materials for application in medicine and source for chemical industry. The Indian sub-continent, having a coastline of above 7,500 km, offers potential for pursuing marine biotechnology research for discovering novel biologically active compounds that could be used in a large spectrum of human ailments and harvest bioresources for sustainable development. Indian labs are concentrating on bioactive substances from marine animals such as horseshoe crab, green mussels, sponges and corals etc. for characterization of novel molecules. Some of the novel molecules have been isolated and commercialized. The Department of Biotechnology (DBT) has been promoting marine biotechnology in India for last one and half decade. A large number of R&D programs sponsored on marine biotechnology are leading towards products and process development and development of viable technology for commercial production systems. Pharmaceuticals and bioprocessing Many bioactive substances from the marine environment have been isolated and characterized and several of them have shown great promise for the treatment of human diseases. Compound manoalide from Pacific sponges reported the development of more than 300 chemical analogs. A significant number of these are going for clinical trials as anti-inflammatory agents. Exploitation of natural agents from the sea has been a hindering problem with limited or sporadic distribution, production and development of selected metabolites. It suggested the need for exploring them either from whole organisms or in vitro cell or tissue cultures of plants and animals. It may help in developing large and complex molecules and synthesize them for standard production through fermentation process. Enzymes The ocean is the source for novel enzymes, produced by marine bacteria having range of unusual properties. Some are salt-resistant, a characteristic that is often advantageous in industrial processes. The extracellular proteases are of particular importance and it can be used in detergents and industrial cleaning applications in cleaning reverse-osmosis membranes. Vibrio species have been found to produce a variety of extracellular proteases. Species of Vibrio alginolyticus are reported to produce six proteases, including an unusual detergent-resistant, alkaline serine exoprotease. Researchers have developed methods to induce a marine alga to produce large amounts of the enzyme superoxide dismutase, which find enormous opportunity in medical, cosmetic, and food sectors. Thermostable DNA-modifying enzymes, such as polymerases, ligases, and restriction endonucleases, already have important research and industrial applications. It has provided the first archaeon (Thermus aquaticus) from which thermostable DNA polymerases were isolated. An unusual group of marine microorganisms is reported to be explored for novel enzymes, isolated of hyperthermophilic archaea, which can grow at temperatures over 100°C. Archaea typically are found in extreme environments, such as hot springs, animal guts, hydrothermal vents, sewage sludge digesters, and hypersaline habitats, including the Great Salt Lake. These novel enzymes became the basis for the polymerase chain reaction (PCR), a useful technique for studying genetic material. Biomolecular materials Recent research has demonstrated that marine biochemical processes can be exploited to produce new biomaterials through a mechanisms used by marine diatoms, coccolithophorids, molluscs and other marine invertebrates to generate elaborate mineralized structures on a nanometer scale. With the unusual and useful properties, research is underway on engineering of the processes for creating bioceramics useful in manufacturing of medical implants, automotive parts, electronic devices, protective coatings and other novel products. Tissue Engineering is another promising area having immense potential in biomedical sciences, useful in organ development, replacement and substitution of damaged tissues. Many marine plants and animals remain free of attached bacteria, either because they produce repelling compounds or because their surface structure neutralizes bacterial adhesives. A product reported to be made available by the seagrass Zostra marina (eelgrass), for example, is an effective agent for preventing fouling by bacteria, algal spores, and a variety of hard-fouling barnacles and tubeworms. Studies on molecular characterization of natural fouling resistance could provide new strategies for fouling control in industrial pipelines or heat exchangers, improved design of trickling filters or aquaculture circulation systems, and control of biofilm infections of medical implants and prosthetic devices. Biomonitors and biosensors Marine organisms can provide the basis for development of biosensors, bio-indicators, and diagnostic devices for medicine, aquaculture and environmental monitoring. Microbial diseases are recognized as a major factor limiting the future of the shrimp aquaculture industry in India, with lost productivity estimated at $6-8 billion per annum. Biomonitor gene probes can be used to identify organisms that pose health hazards or it may also be useful in research. Bioremediation Bioremediation shows great promise for addressing problems in marine environments and in aquaculture. These problems include catastrophic spills of oil in harbors and shipping lanes and around oil platforms; movement of toxic chemicals from land, through estuaries, into the coastal oceans; disposal of sewage sludge, bilge waste, and chemical process wastes; reclamation of minerals, such as manganese; and management of aquaculture and seafood processing waste. The full potential for marine organisms and processes to contribute new waste treatment and site remediation technologies can be realized by understanding of unique conditions in marine environments viz. oxidation- reduction (redox) states and its fluctuation in coastal and estuarine sediments. Biopesticides Natural marine products have the potential to replace chemical pesticides and other agents used to maximize crop yields and growth potential. Unique marine biopesticide in use today was developed from a bait worm's toxin known to ancient Japanese fishermen. This natural pesticide has demonstrated activity against larvae of the rice stem borer, the rice plant skipper, and the citrus leaf miner, among other pests. Novel biopesticides are required to be explored using marine species. Energy biomass It is estimated that approximately 40 percent of all primary energy production, or photosynthesis, occurs in the seas. In this process, oceanic plants viz. phytoplankton, seaweeds and sea grasses in uptake of carbon dioxide (CO2) and with light energy from the sun and convert it into organic carbon and oxygen. The oceans contain 50 times as much carbon dioxide as does the atmosphere and this abundant source of fuel for energy production has not been tapped commercially because it is not competitive with agricultural produce harvested, traditional sources of biomass and biomass is not competitive with other types of fuels. Marine microalgae are being genetically engineered to boost their lipid content, with the aim of providing a source of alternative fuels that is more economical than are conventional sources. Biotechnology is being used to convert biomass to ethanol and other alternative forms of energy and chemical feedstocks. Aquaculture Aquaculture, which long has been practiced in Asia and is increasingly popular in the US, Europe, and South America, will benefit tremendously from the use of new molecular tools and processes. With worldwide seafood demand projected to increase 70 percent in the next 35 years, and harvests from capture fisheries stable or declining, aquaculture will have to produce seven times as much as seafood generates now to supply global demand by 2025. The use of modern biotechnology to intervene in the rearing process and enhance production of aquatic species holds great potential not only to meet this demand, but also to improve competitiveness in aquaculture. Enhancing reproduction and early development Biotechnology can be applied to enhance reproduction and early development of cultivated aquatic organisms. The resulting benefits could include year-round production of gametes and fry of economically valuable species and creation of new markets for specialized, genetically improved broodstock. Similarly, aquaculture biotechnology may provide techniques for improving the reproductive success and survival of endangered species, thereby helping to preservation of the diversity of ecosystem. Improved technologies for cryopreservation of gametes and embryos and delivery systems for administration of natural and synthetic hormones, enhancing understanding of the pharmacokinetics of uptake and release of administered hormones need to be pursued. Improving quality and value Opportunities exist to apply biotechnology in improving seafood processing, for which dedicated research should be conducted to develop and improve technologies. Genetic resources and biodiversity conservation The preservation and enhancement of biodiversity in natural systems is an important priority for supporting programs to maintain and enhance biodiversity in aquatic systems through cultivation, stocking and enhancement. The tools of biotechnology can be used to identify and characterize important aquatic germplasm, including endangered species. The marine environment represents a particularly fertile source for new bacteria, as evidenced by the recent discovery of unusual "cold water" archaea 100-500 meters deep in the oceans. These archaea comprise a high percentage of the total bacterial ribosomal RNA present in seawater samples, yet they have not been isolated in pure culture. Viruses are another newly appreciated element of marine biological diversity. Specific viruses that infect species of marine phytoplankton have been cultured from coastal as well as open ocean sites. Viral infection of higher forms of marine life almost certainly affects global ocean processes, such as photosynthesis. Studies on marine viruses will provide new materials for development of genetic and biotechnological tools that can be used to study and manipulate marine organisms which can be used to genetically engineer higher forms of marine life. Molecular ecology and resource management Research on marine ecology can be conducted to benefit fisheries management. The need for development of understanding marine ecological systems must be developed in order to specify the "normal" baseline level of function and to monitor and predict potential changes and perturbations of systems due to physical, chemical, or biological impacts. The development of predictive models for analyzing potential global climate changes depends on the acquisition of fundamental information on molecular regulatory mechanisms of photosynthesis in the oceans. New molecular tools and techniques New molecular tools should be applied to gain insight into the basic molecular and cellular processes by which marine organisms adapt to extreme environments. These tools should be exploited to accelerate the discovery of unknown marine microorganisms and to expand understanding of known varieties. As new life forms and processes become known and as understanding of them grow, marine biotechnology will make significant contributions to the social and economic well-being. Enhancing biomedical models Marine organisms can provide unique models for research on biological and physiological processes, which could help in studies of developmental, cellular, and molecular aspects of marine organisms. The model systems can provide insights into the basis of disease mechanisms and pathogenesis in humans. Use of mammalian organisms as a basis for the development of some types of human disease models may be neither feasible nor cost effective, where aquaculture animals may be more suitable. Methods need to be developed for culturing tissues from marine organisms. Impact of seas on global environments Marine biotechnology may be useful in assessing the role of the oceans in affecting climate change and the global carbon cycle. Molecular techniques can facilitate and enhance the measurements of CO2 concentrations and total CO2 inventories being developed for global ocean models of carbon cycling. Scientists are required to build a fundamental understanding of marine organisms and their specific adaptations to and interactions with their environment for developing new applications for marine products and processes, analyzing global climate change and improving fisheries management. DBT initiatives The Department of Biotechnology is likely to address several developmental issues in the sector of aquaculture and marine biotechnology through supporting projects in priority areas. Projects have been launched and yielded valuable research leads. During the Eleventh Plan, apart from R&D funding support, major initiatives are likely to be taken up on supporting projects in gaps and priority areas. The possibility of establishment of an autonomous center for marine biotechnology is likely to be considered for discovering novel molecules of therapeutic and biological value. The institute can be dedicated for judicious utilization of marine bioresources using biotechnology tool and techniques. The serious constraint in manpower development in marine biotechnology could be overcome by introducing few M.Sc. / M.Tech. courses in Marine Biotechnology in the country. While understanding the unraveling ocean's hidden wealth and to gear up on scientific knowledge of marine life, establishment of oceanaria is essential as it would help in studying ocean biodiversity through awareness creation. Note: The views expressed are of the author and not necessarily those of the Department of Biotechnology, Ministry of Science & Technology, Govt of India. ]]> <![CDATA[Dr David Chiswell, Glyn Edwards awarded honors]]> https://biospectrumindia.com/news/95/2496/dr-david-chiswell-glyn-edwards-awarded-honors.html https://biospectrumindia.com/news/95/2496/dr-david-chiswell-glyn-edwards-awarded-honors.html Wed, 09 Aug 2006 14:58:00 +0530 Dr David Chiswell Dr David Chiswell, Glyn Edwards awarded honors Dr David Chiswell, former chairman of the BioIndustry Association (BIA), has been awarded an Order of the British Empire (OBE) for his services to the bioscience industry. Glyn Edwards, deputy chairman of the BIA since 2000 and chief executive of Antisoma PLC, has also been awarded a Member of the British Empire (MBE) for his services to the bioscience industry. Dr David Chiswell held the post of chairman of BIA from January 2003 to December 2005. Aisling Burnand, chief executive of the BIA, said, "In addition to their substantial work in ensuring the scientific and commercial success of the UK bioscience companies, both have given generously of their time to other initiatives of benefit for the sector as a whole, not least their roles on the Board of the BIA." Source: www.bioindustry.org EPAA announces 3Rs program to accelerate research in animal testing The European Partnership on Alternative Approaches to Animal Testing (EPAA) has announced details of its first action program, which aims to make significant progress in refining, reducing and replacing animal use (the '3Rs') in the areas of regulatory testing. The Partnership, an unprecedented collaboration between the European Commission and industry, has agreed upon 21 key activities that will be carried out over the next five years. These range from assimilating best research practice from across seven industry sectors, to the evaluation of the regulatory drivers for animal testing, and ultimately the validation and acceptance of alternative approaches to safety testing. The overall program will be co-ordinated by the Partnership's steering committee co-chaired by Georgette Lalis from the European Commission and Colin Humphris representing European industry. The action program is divided into the following five principal themes, which are interlinked and dependent upon one another: Evaluation of the regulatory drivers for animal use, map and evaluate past and current 3R activities, prioritize and implement research based on 3Rs, validate new and alternative test methods and strategies, and identify, disseminate and implement 3R best practice across the EU. The five areas will be managed in an integrated fashion to ensure consistency. According to a release, an annual report from the Partnership on the implementation and impact of the action program will be published for the public. The first report on implementation should be available by December 2006. The program will be reviewed on a regular basis. Source: www.europabio.org RIEC okays plans for 3 research sectors The Research, Innovation & Enterprise Council, Singapore (RIEC) has approved three strategic research programs: Biomedical Sciences Phase II; Environmental and Water Technologies; and Interactive and Digital Media. These three sectors target to provide a total of 86,000 jobs with value added of $30 billion by 2015. These programs would be implemented over the next five years (2006-2010). To build up a concentration of research talent to foster innovation and creativity, the RIEC also approved the concept to establish a Campus for Research Excellence and Technological Enterprise (CREATE), and the proposal to set up the Singapore-MIT Alliance for Research and Technology (SMART) Centre as the first centre within the Campus. Prime Minister Lee Hsien Loong, chairman of the RIEC, said, "Singapore is committed to invest in R&D as a driver for economic growth and as a foundation for our long-term competitiveness. Our priorities are firstly, to build up core R&D capabilities in selected strategic areas, and secondly, to attract and develop a significant concentration of talent to sustain a critical mass of advanced research activity into the long term. The abundance of career opportunities in R&D will encourage more to pursue advanced higher education." The RIEC approved the allocation of S$1.38 billion over the next five years to fund the development of the three strategic research program - Biomedical Sciences (BMS) Phase II - S$550 million, Environmental and Water Technologies (EWT) - S$330 million and Interactive and Digital Media (IDM) - S$500 million. The funds will be held in the National Research Fund administered by the National Research Foundation (NRF), which will oversee the implementation of programs approved by the RIEC. The RIEC and National Research Foundation will continue to explore other emerging areas beyond these three programs; and opportunities for synergy and cross-disciplinary research at the interfaces between the three research areas. Source: www.biomed-singapore.com "Industrial biotech plays key role for rural economic development" "Industrial biotechnology is the enabling technology that allows us to convert crops to fuels, renewable chemicals and bio-based products of all sorts. The US Department of Agriculture (USDA) is committed to seeing the industrial biotechnology sector used more and more widely throughout the manufacturing and energy sectors," said Thomas C Dorr, under secretary for rural development, US Department of Agriculture. Addressing the third annual World Congress on Industrial Biotechnology and Bioprocessing at Toronto, Thomas Dorr said, "The US government is interested in industrial biotechnology for rural economic development, since it will play an important role in rural agricultural economies. As the biotechnology revolution rests squarely on agricultural feedstocks, this is also an extraordinary opportunity for American agriculture and, more broadly, for investment, growth, and wealth creation not just in rural America, but also in rural areas all across this globe." Dorr further said, "From a rural development standpoint, sustainable development - investment, jobs, and wealth creation in rural communities - that is my goal. Biotechnology - in the form of biofuels and in the form of other bio-based products - offers rural America its largest new opportunity in history." Brent Erickson, executive vice president of the Biotechnology Industry Organization's (BIO) Industrial & Environmental Section, said, "Industrial biotechnology is being widely adopted throughout the US economy - in energy, chemicals, and manufacturing. In 2005 and 2006, it really came of age, driven by a 'perfect storm' of high energy prices, low energy security, developing market pull, and technological products reaching the market. These factors mean that industrial biotechnology has reached a tipping point and has become a mega-trend." Source: www.bio.org ]]> <![CDATA[Philippe Archinard is new chairman of France Biotech]]> https://biospectrumindia.com/news/95/2397/philippe-archinard-is-new-chairman-of-france-biotech.html https://biospectrumindia.com/news/95/2397/philippe-archinard-is-new-chairman-of-france-biotech.html Wed, 09 Aug 2006 14:57:00 +0530 Philippe Archinard is new chairman of France Biotech Philippe Archinard is new chairman of France Biotech During the annual general meeting of France Biotech, the French biotechnology industry association, in Paris, the members of the association, re-elected one fifth of its Board (three Board members), as stipulated by the association's statutes. The renewed Board elected Philippe Archinard as chairman. Philippe Archinard succeeds Philippe Pouletty, who held three terms since 2001, and chose not to seek for a further mandate. With this Philippe Pouletty becomes Honorary Chairman of France Biotech that currently has 150 members. It thus represents most of the French biotech industry's investments, product pipelines and employees. Philippe Archinard, 46, joined Euronext-listed Transgene as chief executive officer (CEO) in December 2004. Philippe Archinard has been able to raise 35 million in a public refinancing round, seven months after joining the company. During 2000-2004, he had set a new strategy for Innogenetics, a 600-employee, Euronext Brussels-listed Belgian company, by positioning it as a leader in high value-added diagnostics, focusing on infectious diseases, neurodegeneration, and genetic testing. Philippe had previously spent 15 years at BioMÃ©rieux, where he held a range of management positions (including as CEO of the company's US operations). Philippe Archinard holds a degree in chemical engineering and a PhD in Biochemistry from Lyon University, and has completed the Program for Management Development at Harvard Business School. Philippe Archinard said, "Our upcoming Action Plan features the need to free up the financing chain for innovative SMEs downstream in order to boost investment upstream and produce European champions; work closely with research institutes to better promote and enhance French academic research; extend France Biotech's activities and network to the entire life science industry; and continue promoting the social and ethical value, as well as the image of life science." Source: www.france-biotech.org Dhaka outlines biotech policy Bangladesh has adopted the National Policy Guidelines on Biotechnology to accelerate multidimensional research for food security, health and environment. Following a recommendation by the National Task Force that was formed in early 2004, the policy was framed after extensive research. The broad objectives of the policy aim at increasing production and preservation capacities of various crops, fish and medicinal items as well as restoring various useful species and ensuring safety of public health and environment. The National Task Force on Biotechnology chaired by the country's Prime Minister Khaleda Zia has delineated a 20-year-long roadmap on biotechnology "on priority basis" to utilize the potentialities and scope for development, research and application of biotechnology to alleviate poverty, increase food security and improve health, nutrition and livelihood of the people. McKinsey report predicts growth in industrial biotech sector McKinsey & Company has predicted that by 2010 industrial biotechnology will account for 10 percent of sales within the chemical industry, accounting for $125 billion in value. Jens Riese, a partner at McKinsey & Company, presenting the up-to-date data and projections for adoption of industrial biotechnology within the biofuels and chemicals industries, in a plenary titled "Industrial Biotechnology-Turning Potential into Profits," at the third annual World Congress on Industrial Biotechnology and Bioprocessing in Toronto, said that McKinsey & Company has 90 percent confidence in this projected growth, based on the current value of industrial biotechnology. Already as of 2005, industrial biotechnology - counting products made from biobased feedstocks or through fermentation or enzymatic conversion - accounts for 7 percent of sales and $77 billion in value within the chemical sector. Much of the projected growth in adoption of industrial biotechnology is attributable to biofuels - ethanol and biodiesel - as production is rapidly increasing to meet demand driven by government mandates. Other areas projected to grow rapidly include pharmaceutical ingredients, polymers, and enzymes. However, Riese stressed, to meet future demand and maintain growth, biofuel production will have to adopt biotechnology processes that make use of broader feedstocks, including cellulose biomass. "To meet demand just from mandated usage, we need to do something different. The key to expanding biofuel production is tapping into new agricultural feedstocks," Riese said. Source: www.bio.org ]]> <![CDATA[Japan can combine biotech with other advanced technologies]]> https://biospectrumindia.com/news/95/6527/japan-can-combine-biotech-with-other-advanced-technologies.html https://biospectrumindia.com/news/95/6527/japan-can-combine-biotech-with-other-advanced-technologies.html Wed, 09 Aug 2006 14:54:00 +0530 New Page 1 'Japan can combine biotech with other advanced technologies' - Seizo Sumida, MD, Japan Bioindustry Association Japan Bioindustry Association (JBA) traces its roots 50 years back to the Japanese Association of Industrial Fermentation, its predecessor organization. JBA is a non-profit organization dedicated to the promotion of bioscience, biotechnology and bioindustry in both Japan and the rest of the world. Established through the support and cooperation of industry, academia, and government, JBA functions as a think tank and platform for communication between scientists, technologists, policymakers and managers. In an e-mail interview with BioSpectrum, Seizo Sumida, managing director, JBA throws light on the state-of-affairs in the life sciences industry in Japan. What is the size of the Japanese biotechnology industry? The modern biotechnology-based market in Japan was worth approximately $17 billion in 2004. It has grown more than eight-fold over the past 16 years. Biopharmaceuticals account for 31 percent of the market, transgenic agro-foods for another 31 percent, chemicals (enzymes, diagnostics, etc.) for 26 percent, and others (analytical equipment, bioinformatics, etc) lay claim to the remaining 12 percent. We expect that the biotechnology market will continue to grow steadily in Japan. What are the areas of focus and how are those sectors growing? Pharmaceutical sector is one of the focused areas. Japanese pharmaceutical industry has been facing a number of challenges in recent years. First, the government has continued to lower official drug prices to slow the increase of the healthcare budgets. Second, the ICH guidelines that harmonize international pharmaceutical regulations have intensified competition within the Japanese market, because of intensified sales efforts by foreign multinationals. Third, the new good clinical practice guidelines have made it more complicated to conduct clinical trials in Japan. And fourth, pharmaceutical companies have had to increase their R&D expenditures dramatically since the advent of genomics. Japanese pharmaceutical companies have been coping with these challenges by strengthening their R&D and sales capabilities at home and abroad. Mergers and acquisitions have become more common in Japan these days. Functional foods sector is another focused area. Functional foods are items such as cooking oil that is not fattening, allergen-free foods, foods that activate the immune system, and foods that help prevent cancer. Functional foods are finding an increasing size of market in Japan, because Japanese consumers have been getting increasingly health conscious. Biotechnology can revolutionize food industry though its contribution to the development of functional foods. What are the incentives that are being offered to the biotech companies? The government created Biotechnology Strategy Council (BTSC) in 2002. Chaired by Prime Minister Koizumi, BTSC consists of cabinet members along with experts from academia and industry. BTSC addresses R&D, commercialization and public understanding of biotechnology. In December 2002, BTSC announced a comprehensive "National Strategy on Biotechnology" outline comprising 200 detailed action plans that cover a wide range of areas. Under the auspices of Japan's Parliamentarians Life Science Promotion Alliance, "Life Science Summit" meetings have been convened every year since 2000. Parliamentarians, government officials, academics and industry leaders have gathered together to discuss Japan's national strategy on biotechnology. Industry participants take this occasion to make sure that the BTSC's action plans are correctly implemented. What are the strengths that Japan has in biotechnology? Japan has shown her strengths in a number of areas of biotechnology, such as sequencing of human full-length cDNAs, glyco-chain technology and bioinformatics, in addition to fermentation technology, enzyme engineering and environment-friendly products. Japan also has strengths in combining biotechnology with other advanced technologies such as nanotechnology, robotics, and electronics to create a new generation of advanced technologies. There is sudden rise in the number of bio companies in the last seven-eight years in Japan (from 10 companies in 1998 to 450 in 2004). What prompted Japanese entrepreneurs to look at entering biotechnology, a niche market space? In 1990s, Japan was experiencing a prolonged economic recession. A number of reforms were tried to overcome the recession. To give you an example, legislation to corporatize all the national universities was one of them. The law took effect in April 2004. Today, faculty members can be involved in entrepreneurship. The creation of spin-off bioventures involving universities has been increasing nationwide. Their contribution to strengthening of R&D capability of Japanese bioindustry is likely to become more significant in the coming years. Narayan Kulkarni ]]> <![CDATA[Demand for freeze dryers to increase]]> https://biospectrumindia.com/news/95/1600/demand-for-freeze-dryers-to-increase.html https://biospectrumindia.com/news/95/1600/demand-for-freeze-dryers-to-increase.html Wed, 09 Aug 2006 14:52:00 +0530 Demand for freeze dryers to increase Demand for freeze dryers to increase The sale of freeze dryers to the biotech industry has seen a steady growth in the last few years. It is expected to pick up as companies like the Serum Institute of India are soon to launch lyophilized biotech products. Freeze-drying is a method of preserving products, ideal for preserving the properties of active ingredients (proteins, enzymes), microorganisms, chemical and natural products. In the bio industry, freeze dryers are used to preserve living cells, vaccines, whole blood and biological specimens. They find application in specimen preparation for scanning electron microscopy and transmission electron microscopy. Some of the global players who are manufacturing and supplying freeze dryers include Warwick Manufacturing & Eqipment Co, Niro, and LTE Scientific, BOC Edwards, Girovac, Labconco, Thermo Electron, Elliott Bay Laboratory, Angler Web Services, The Pump Works, Kinetics Thermal Systems, Cole-Parmer Instrument, Pharos Consultancy, VirTis, TGR, Hull Company, Global Medical Instrumentation, American Lyophilizer, Freeze Dry Co and Martin Christ. In India, both local and multinational players sell freeze dryers. Some of the key players in this space include Martin Christ, Lyophilization Systems, Thermo Electron, Labconco, VirTis, Operon and LTE Scientific. Most of the multinationals have distributors to offer a range of freeze dryers in the country. Biodigital India represents Martin Christ for its range of freeze dryers in the country and offers laboratory, pilot and also production scale dryers. Sunjay Technologies Pvt Ltd represents LTE Scientific UK, Raj International represents a Chinese company called Shanghai Tofflon Science & Technology Co Ltd; Care Biomedicals represents Labconco; JH Bio Innovations Pvt Ltd represents a Korean company Operon; and Spinco Biotech represents R&D freeze dryers from VirTis, USA. Other companies who are into the manufacture of production scale freeze dryers in India include Rattan Sales Corporation and Lyophilization Systems. Lyophilization Systems, a US-based multinational company is amongst the key manufacturers and suppliers of lyophilizer, freeze drying equipment and freeze dryers for the pharmaceutical, food and research industries. Freeze dryer machines are manufactured in India. Rattan Sales Corporation, a group company of Rattan Group of Industries, which is engaged in providing total solutions in lab equipment, has also been manufacturing freeze dryers for the last 10 years. It has been offering its freeze dryers under the brand name Spencers. Market scenario "The overall market for freeze dryers is growing at a rate of 20 percent. A major user of freeze dryers is the food processing industry. It is followed by pharma and biotechnology. Freeze dryers are available in the price range of Rs 10 lakh to Rs 2.5 crore. The high- cost dryers are mainly used in the production houses," said Narendar D, manager, Lyophilization Systems India Pvt Ltd. Manoj Shilotri, product manager, Care Biomedicals, which represents Labconco in India said, "There are two types of freeze dryers available. One for laboratory level and other one for the production level. We offer lab scale freeze dryers. There has been a steady growth for freeze dryers in the last three to four years. On an average about 100 units of lab scale freeze dryers are sold per year. In the lab scale category, freeze dryers are available from one liter to a maximum of 25 liters. Each unit will cost anywhere between $5,000 and $40,000. Although there are few local manufacturers, they find it difficult to match the imported units in terms of quality." Akshay Mehta, director, sales and marketing, Sunjay Technologies Pvt Ltd, that represents LTE Scientific said, "Freeze dryers have wider applications and are used in different sectors like food processing, fisheries, biotechnology and blood sampling. On an average about 20-30 units costing Rs 4-18 lakh are being sold to the companies and institutes involved in biotechnology. Since quality is the key factor in biotechnology, companies prefer imported products." Sharing his views, Pratul Kumar, manager, sales and technical services, Rattan Sales Corporation said, "The market for freeze dryers has been opening up in the biotechnology space in the last few years. We are receiving about 10-12 enquiries every month from pharma and biotech companies. The situation was not similar a few years back. In spite of this, it is difficult to predict the growth of the market for any equipment." Realizing the applications of freeze dryers, biotech companies like the Serum Institute of India are now working on lyophilized biotech products. Once this becomes a reality, the demand for freeze dryers will increase in the coming years. And in addition, if the companies who are supplying the freeze dryers get some kind of relief from the government in the form of duty reduction, there is every possibility that it will be passed on to the biotech industry. The market for freeze dryers is expected to grow in the coming years with the growth of biotech industry. Narayan Kulkarni ]]> <![CDATA[Mesoblast uses adult stem cells for fractur]]> https://biospectrumindia.com/news/95/3819/mesoblast-uses-adult-stem-cells-for-fractur.html https://biospectrumindia.com/news/95/3819/mesoblast-uses-adult-stem-cells-for-fractur.html Wed, 09 Aug 2006 14:48:00 +0530 Mesoblast uses adult stem cells for fractur Mesoblast uses adult stem cells for fractur For the first time an Australian company has successfully implanted adult stem cells in a patient for repair of a long bone fracture. Mesoblast Limited, an Australian biotechnology company focused on the development of novel treatments for orthopedic conditions, has implanted specialist adult stem cells in an orthopedic patient using its unique and proprietary technology. After the procedure, the patient was reported in a stable condition and was expected to be released from hospital shortly. The director of Orthopaedics at The Royal Melbourne Hospital, Richard de Steiger, where the implant took place, said, "The patient had sustained a major fracture of his femur some nine months ago, which had not healed. For this type of non-healing defect, we would typically consider a bone graft using a large amount of bone taken from the patient's own hip. However, this often results in long-term complications including pain and possible infection. The use of adult stem cells could result in the healing of the defect without the complications of a bone graft taken from a separate incision." Under the procedure, a needle is used to remove bone marrow from the pelvis and specific stem cells are extracted and multiplied for about six weeks. The cells are then surgically inserted into the patient to grow into blood vessels and tissue or into bone. "If successful, this procedure may significantly reduce or eliminate long-term patient complications, whilst decreasing hospital time and costs associated with the treatment of long bone fractures," de Steiger said. The pilot trial at the Royal Melbourne Hospital is an independent assessment of the safety of Mesoblast's specialist adult stem cell technology. This pilot trial will involve up to 10 patients suffering from non-union, long bone fractures. These fractures are usually a result of accidents and affect many thousands of people each year in Australia and as many as two million people in developed countries around the world. IBN's hydrogel could lead to safer disease treatments Scientists at the Institute of Bioengineering and Nanotechnology (IBN) in Singapore are on their way towards making a medical breakthrough in the area of targeted drug delivery and tissue engineering, by inventing an injectable hydrogel that can deliver drugs at specific locations or act as a scaffold in bone and cartilage repair. "My colleagues and I have been exploring the enzymatic polymerization of polyphenol compounds and evaluating their biological activities. We found that this enzymatic reaction is benign and suitable for manufacturing biomaterials that use biocomponents such as proteins and cells as these components do not lose their bioactivity nor cause tissue damage," said Dr Motoichi Kurisawa, who led this project. "From the findings, we developed an idea to apply the enzymatic reaction in an injectable hydrogel system, which excludes the need for toxic chemicals." According to the researchers, IBN's hydrogel has numerous advantageous. Firstly, it can be formed easily within the body through injections at the desired site. The hydrogel will form directly at the site, due to two types of solution-a fluid drug-loaded biodegradable polymer and an enzyme, which acts as the gelation catalyst. From here drugs or cells contained within the hydrogel can be released at a controlled rate. This means that unlike conventional hydrogels, no surgery is required to implant the hydrogel. Furthermore, due to its biodegradability, surgery is also not required to remove the hydrogel as it decomposes safely within the body. Secondly, composed from almost 90 percent water, the hydrogel is non-toxic. It is formed from hyaluronic acid-tyramine (HA-Tyr) conjugates with enzyme, which does not cause any tissue damage. The HA forms the main backbone polymer while the Tyr is the cross-link moiety. This chemically cross-linked hydrogel is superior as it is able to retain its stability for a longer time in the body and does not use any toxic chemical crosslinkers, which lead to inflammation and redundant reactions with bioactive agents in the body. The potential for medical applications for this hydrogel are tremendous and already the research team is in discussion with both companies and hospitals for taking the research further downstream through possible collaborations. ]]> <![CDATA[Vitamin A triggers meiosis]]> https://biospectrumindia.com/news/95/1181/vitamin-a-triggers-meiosis.html https://biospectrumindia.com/news/95/1181/vitamin-a-triggers-meiosis.html Wed, 09 Aug 2006 14:47:00 +0530 Vitamin A triggers meiosis Vitamin A triggers meiosis An Australian research team has solved one of biology's most fundamental questions â€“what triggers the germ cells to produce sperms in males and eggs in females. The finding is a breakthrough that could lead to improved infertility treatment, cancer therapy and pest management. The team, led by Dr Josephine Bowles and Prof. Peter Koopman from the Institute for Molecular Bioscience at The University of Queensland, has discovered that derivatives of Vitamin A trigger the beginning of egg and sperm production, a process known as meiosis. The cells that eventually turn into either eggs or sperm-known as germ cells-are identical in male and female embryos. According to Prof. Koopman, the timing of the reduction of cell division or meiosis determines whether the germ cell will develop into an egg or a sperm. In females, meiosis begins before birth and eggs are produced, whereas in males, meiosis begins after birth and the result is a sperm. Prof. Koopman and his team found that retinoic acid, a derivative of Vitamin A, causes germ cells in female embryos to begin meiosis, leading to the production of eggs. They also discovered an enzyme present in male embryos that wipes out retinoic acid and so suppresses meiosis until after birth, resulting in sperm production. Nobody had been able to figure this out till now. It is expected that this discovery will provide the basis for a number of practical applications. It may allow researchers to improve fertility, for example in the case of an infertile couple wanting a baby, or suppress it, in the case of pest management. Prof. Koopman has also suggested that an inappropriate retinoid signal might give the wrong instructions to germ cells, which could lead to the formation of germ cell tumors. Novel approach to tackle avian flu Chinese researchers have devised an innovative way to tackle the deadly avian flu. According to a pilot study conducted by Jiahai Lu of the School of Public Health at Sun Yat-sen University, Guangdong Province, China, passive immunotherapy is the best way to treat highly pathogenic avian influenza in humans. Passive immunotherapy uses antibodies from horses. Purified antibodies to the H5N1 strain of avian influenza derived from horses were used against mice and it proved effective in preventing the disease. The researchers reported their findings in the journal Respiratory Research. Passive immunotherapy is an alternative strategy used to treat H5N1 infection. The researchers reported two experiments, both using highly purified Fragment Antigen Binding (FAB) molecules derived from equine antibodies to the H5N1 hemagglutinin glycoprotein. In the first experiment, they showed that the equine (horse) antibodies prevented the infection of dog kidney cells. In the second one, the researchers showed that the equine antibodies prevented death from H5N1 flu in infected mice, which are known to be susceptible to the H5N1 flu. The mice were divided into four groups-each group containing 10 mice. The mice were infected with the H5N1 virus and after 24 hours three groups of mice were injected intraperitoneally with 50, 100, or 200 mcg of the antibody preparation. The fourth group, used as controls, received 200 mcg of normal horse sera. The H5N1 infection was fatal to all the control mice. But seven of the 10 mice which were given 50 mcg of the antibody preparation and the mice that were given higher dosages survived. Dr Lu and colleagues reported that this method can be used until an efficacious vaccine, specific anti-H5N1 agents, and effective epidemiologic control measures for H5N1 virus infection was discovered. Dr Lu and colleagues concluded that H5N1-specific passive immunotherapy can be used for the early treatment of avian influenza patients to reduce the severity of illness and the likelihood of H5N1 transmission to others. But they also said that there is a major disadvantage as in these procedure polyclonal antibodies derived from horses has the potential to cause a strong host immune response, which might inhibit its use in the clinic. ]]> <![CDATA[Vaccine against IPD launched in India]]> https://biospectrumindia.com/news/95/2267/vaccine-against-ipd-launched-in-india.html https://biospectrumindia.com/news/95/2267/vaccine-against-ipd-launched-in-india.html Wed, 09 Aug 2006 14:42:00 +0530 Vaccine against IPD launched in India Vaccine against IPD launched in India Prevenar, a pneumococcal conjugate vaccine against meningitis, pneumonia, and septicaemia has been launched in India. Pneumococcal disease is a group of illnesses caused by the bacteria Streptococcus pneumoniae, also known as "Pneumococcus". Infants and children are at greatest risk for invasive pneumococcal disease as 25-60 percent of them are carriers of pneumococci in their throats. The risks of meningitis and bacteremia are greatest during the first two years of a child's life. With the recent introduction of Prevenar, a protein-polysaccharide conjugate vaccine launched by Wyeth Ltd in India, a sharp decline in the incidence of Invasive Pneumococcal Disease (IPD) among infants is anticipated. Prevenar is the first and only pneumococcal conjugate vaccine for infants and toddlers that protects a child against pneumococcal diseases like meningitis, bacterial pneumonia, septicaemia and bacteraemia (bacteria in the blood). Dr Mark Fletcher, director, international scientific and clinical affairs, Wyeth Vaccine Research, Paris, France, said, "Globally invasive pneumococcal disease is responsible for more than one million child deaths every year according to the WHO. Research has shown that Streptococcus pneumoniae strains are now increasingly resistant to penicillin and other antibiotics and simultaneously the prevalence of these strains continues to rise worldwide. The focus accordingly needs to shift from treatment to prevention. Wyeth has therefore developed Prevenar, a seven-valent vaccine, which is used worldwide and is now part of the regular immunization schedule in many countries. Since the licensure of Prevenar globally in 2000, 30-40 million children have been protected against invasive pneumococcal disease." Ranga Iyer, director, Wyeth Ltd, said, "Prevenar will protect children from invasive pneumococcal disease that is responsible for many cases of childhood mortality and morbidity. We believe that this vaccine-the only one of its kind in the world-will not only protect children from critical diseases but also reduce the disease burden in India to a great extent." "Invasive pneumococcal disease staggers the imagination. It is a disease that takes 1 million innocent lives every year, all succumbing to IPD before their fifth birthday. Of those who survive, some grow up with permanent disabilities such as seizures, deafness, paralysis and mental retardation," Baldev Arora, area vice president, South Asia and South East Asia, Wyeth Ayerst, said. Dr Nitin Shah, president of the Indian Academy of Paediatrics, and consultant paediatrician, PD Hinduja National Hospital, Mumbai, said, "Invasive pneumococcal disease has become a cause for concern amongst infants and toddlers worldwide and in India. This can cause potentially life-threatening illnesses. In today's environment there is need for a vaccine that can provide this much-needed protection." Pneumococcus is commonly found in the nose and throat of healthy children and adults. Individuals who harbour pneumococcus in their nasopharynx can potentially infect others through close contact or airborne particles, such as those found in sneezes or coughs, though not all individuals exposed to infection will become ill. The colonization of pneumococci in young children is very common. Children are, therefore, both major carriers and victims of pneumococcal disease. Invasive pneumococcal disease (IPD) includes bacteraemia (bacterial infection of the blood), sepsis (an infection in the blood), meningitis (bacterial infection of the lining of the spinal cord and brain) and bacteraemic pneumonia (an infection of the lung). The spread of pneumococcus from the nasopharynx to the upper and lower respiratory tract can result in non-invasive pneumococcal disease, including bacterial pneumonia, acute otitis media (inflammation of the middle ear) and sinusitis (infection of the sinuses). In cases of untreated patients or treatment failure, pneumococcal disease can lead to hearing loss, paralysis and sometimes death. Prevenar is administered in three doses to children below the age of two years-6-10-14 weeks after birth and a booster dose at 12 to 15 months. It is already available in 75 countries, and is part of the national immunization schedule in six countries, including the US, Canada and Australia. Currently, Prevenar is also cleared for marketing in Argentina, Australia, Brazil, Chile, Colombia, Curacao, Malta, Peru, Mexico, Trinidad and Tobago, Switzerland and throughout the 15 member countries of the European Union. Prevenar is also available in South Korea, Singapore, Malaysia, Thailand, Philippines and Hong Kong. Namratha Jagtap ]]> <![CDATA[Profiles of Top BioSuppliers]]> https://biospectrumindia.com/news/95/5738/profiles-of-top-biosuppliers.html https://biospectrumindia.com/news/95/5738/profiles-of-top-biosuppliers.html Wed, 09 Aug 2006 14:39:00 +0530 Better Science Better Science Waters India is a leader in high performance liquid chromatography and mass spectrometry products. Waters Corporation's high performance liquid chromatography (HPLC), mass spectrometry (MS), and services are synonymous with quality and performance in analytical labs around the world. Waters is a publicly traded corporation (NYSE: WAT) headquartered in Milford, Massachusetts. It is a member of the Standard and Poors' 500 Index. The company has manufacturing facilities located in Milford, Massachusetts, Taunton, Massachusetts, Wexford, Ireland and Manchester, England. Waters sells direct in most of the countries its serves. Waters differentiates from the competition by providing best in class products backed up by best services in the analytical instrument industry in India. Waters sales and marketing personnel and the service engineers are highly trained and have great regard in the industry. Waters Corporation are the recipient of Omega Northface Scoreboard Award for excelling in customer service expectations. The study covers Technical support, field service, Sales Process, customer service and Product Quality. The "Acquity UPLC" through its "disruptive Technology" broke through the conventional performance barriers of speed,sensitivity and Resolution. Waters Acquity Systems sets new standards in terms of speed, throughputs and quality of LC and MS Analysis. Waters India started operation in 1988. In 1997, it became a subsidiary of Waters Corporation. Major areas of activities in India include: sales and marketing of LCs, MS, informatics solutions and the wide range of columns and chemistries supported by a wide network of Customer Support group. Customer support includes apart from installation and maintenance support of equipment, exhaustive efforts in the areas of application support,customer education programs and validation support. KV Venuguoplan has been president of Waters India since it became a subsidiary of Waters Corporation. Under his leadership, Waters India business has grown at a high double digit for the past five years. Waters India has achieved the distinction of best performing subsidiary of Waters Corporation in 2005. Waters India is headquartered in Bangalore with field offices in Mumbai, Hyderabad, New Delhi, Chandigarh, Ahmedabad and Kolkata. Waters customers in India are the major biotech, pharmaceutical companies and major testing centres. Its products and services help the pharmaceutical companies analyze their products to develop new molecules, to determine physico-chemical properties, conduct clinical trials and meet quality requirements for release of manufactured products. Most major prescription drugs are analyzed on Waters instruments. With addition of Informatics solutions range, Waters can provide comprehensive end-to-end solution for labs, from sample preparation, to data handling to report generations for submissions. Waters Corporation is a leader in liquid chromatography and mass spectrometry products world over and Waters India is leader in this market in India. Instrumented Sophistication Instrumented Sophistication Instrumented Sophistication Spinco Biotech has come a long way since its inception. Today it is a trusted name in the Indian instrumentation industry and represents some of the best principals in the world. S pinco Biotech celebrates its silver jubilee in 2006. Well known among the customers as distributors for Shimadzu HPLC, Spinco Biotech offers an array of instruments for Proteomic and Genomic research. With a network of fifteen offices and two hundred plus marketing, tech-support, application and customer relationship personnel, Spinco Biotech is one of the market leaders in analytical and life science instruments in India. The two important milestones in the history of Spinco Biotech are the gifting of the 2000th HPLC to Cancer Institute, Chennai on February 5, 2000 by the then Chairman of Shimadzu Corporation and the recent Customer Appreciation Banquet held in December 2005 celebrating the 1000th installation of LC-2010HT integrated HPLC. The company also distributes Shimadzu LCMS, Protein Sequencer, DNA Sequencer and GC, GC-MS for Andhra Pradesh, Eastern and North Eastern India. To complete the chromatography product line, Spinco Biotech is associated with various other manufacturers of detectors, columns and consumables. A few of them are: Wyatt Technology, USA (Molecular Size and Weight Detector), Polymer Laboratories, UK (Evaporative Light Scattering Detector), IN/US Systems, USA (Radio Chromatography Detector), PDR-Chiral, USA (Chiral Detectors) and Antec-Leyden, Netherlands (Electro Chemical Detector). Spinco Biotech promotes HPLC columns of Phenomenex, USA and Chiral Columns of Daicel Chemical Industries, Japan. The group company Spincotech keeps stock of huge inventory of chromatography consumables and spares to supply almost from stock. Spinco Biotech also has a strong portfolio of products under the Life Science Group. It is associated with Affymetrix Inc., USA (GeneChip System, the Gold Standard for Microarray), Kratos Analytical, UK (MALDI TOF-MS), Shimadzu-Biotech, Japan ('Xcise'-Automated Gel Processing, ChiP-for Peptide Mass Fingerprinting and Protein Macroarray Analysis, 2D Micro-HPLC for proteome analysis and AccuSpot for automatic LC micro-fractionation and spotting) and APPTEC, USA (Peptide and Organic Synthesizers) etc. It also distributes NIR systems for instantaneous measurement of raw material from Foss NIR, USA. Laboratory, R&D Freeze dryers from VirTis, USA and Production capacity freeze dryers from Hull, USA are the other products, the company is known for. Precision Mechanist Precision Mechanist Precision Mechanist India's growing economy and precise R&D activities will help Shimadzu Analytical (India) increase its growth rate. Shimadzu Analytical (India) Pvt Ltd, a wholly owned subsidiary of Shimadzu Corporation, Japan has been offering technologies in the field of analytical and scientific instrumentation, diagnostic medical imaging, and process control instrumentation, environmental monitoring to different industries including life sciences and biotechnology. It takes pride in the R&D in the areas of its specialization. Shimadzu has established its name in the R&D and QA labs in the country. In April 2006, it has opened its customer support center equipped with the state-of-the-art instruments in Mumbai. The center will focus on customer training and aid in analytical method development for its customers. Shimadzu Analytical (India) is investing about Rs 4 crore (100 million Yen) in India. With an initial staff strength of 20 personnel, it plans to increase it to 40 within a year. In addition to overseeing the activities of the customer support center, it will also provide marketing support to its distributors. With an annual turnover of Rs 150 crore, Shimadzu has been marketing its products through distributors namely Toshvin Analytical, Amkette Analytics, Swan Environmental, and Spinco Biotech for more than 35 years (since 1970). About 60 percent of its total sales were from the life sciences industry. Shimadzu has 30 percent market share in the analytical and scientific instrumentation market in India that is estimated to be about Rs 500 crore. Shimadzu is setting up a software development center to meet the Corporation's software needs. The center will also act as a support hub to the South Asia region. Shimadzu is looking at achieving a target of Rs 300-400 crore in the next five years. Shimadzu's biotech division is focused on providing integrated solutions for life science and drug development and accelerate the progress of biotechnology in research and development. Shimadzu Biotech represents a new way of thinking in the health and life science sectors by combining a core competence in instrument design and manufacture together with strategic partnerships to advance the development of knowledge in biotechnology. Product offerings include mass spectrometry integrated with enabling technology for high throughput analysis (MALDI, LC/MS, automated systems for analyzing gels with mass spectrometry) and specific solutions for DNA analysis (ranging from UV spectroscopy to chip-based electrophoresis) among a range of other offerings. One of its researchers, Dr Koichi Tanaka, shared 2002 Nobel Prize for chemistry for the development of Matrix Assisted Laser De sorption Ionization, a popular technique to ionize proteins, a useful tool in biotechnology research. Health Booster Health Booster Health Booster GE Healthcare's vision for the future is to enable a new 'early health' model of care focused on early diagnosis, pre-symptomatic disease detection and disease prevention. GE is a diversified company with each of its businesses managing their own staffing needs, including foreign assignments. GE Healthcare provides transformational medical technologies and its expertise in medical imaging and information technologies, medical diagnostics, patient monitoring systems, drug discovery, and biopharmaceutical manufacturing technologies is helping clinicians around the world re-imagine new ways to predict, diagnose, inform and treat disease. GE Healthcare's broad range of products and services enable healthcare providers to better diagnose and treat cancer, heart disease, neurological diseases, and other conditions. The company's vision for the future is to enable a new "early health" model of care focused on earlier diagnosis, pre-symptomatic disease detection and disease prevention. Headquartered in the UK, GE Healthcare is a $15 billion unit of General Electric Company (NYSE: GE). Worldwide, GE Healthcare employs more than 43,000 people committed to serving healthcare professionals and their patients in more than 100 countries. GE Healthcare is broadly divided into five areas of research, bioprocess, protein sciences, discovery sciences, genomic sciences and services. The company has equipment and reagents to target these four broad categories (plus services). Its India branch office is a direct marketing and sales office for the Global GEHC life sciences group. The products range from drug screening, cellular assays, cell processing, nucleotides, enzymes, biochemicals, radiochemicals, nucleic acid synthesis, amplification and purification, DNA sequencing, microarrays, proteomics, electrophoresis, spectrophotometry, blotting, imaging and analysis to protein purification. Recently GE announced a $250 million infrastructure investment in India, with projects targeted in infrastructure, healthcare and real estate. ''Our target is to create sales and assets worth $8 billion by 2010. We will focus on infrastructure, while increasing our footprint in financial services, technology and developing business with our local partners,'' GE chairman and CEO, Jeff Immelt said. GE will be a partner in Dr Naresh Trehan's Medicity project, a world-class integrated healthcare facility in New Delhi. Beyond financial investment, GE will also provide end-to-end early disease prediction, diagnosis and monitoring tools like advanced medical diagnostics, Cathlabs and anesthesia systems, and partner in clinical research and education programs. GE Healthcare is focusing on educating and implementing an early health model, while developing and introducing new products designed to meet specific Indian needs - delivering easier, earlier and more accurate care in locations with limited access to hospitals. It is setting up India's first radiopharmacy center in Delhi. The new radiopharmacy center will offer isotopes and radiopharmaceuticals in unit doses to various nuclear medicine hospitals and healthcare centers in and around Delhi. The company has planned additional radiopharmacy centers for Mumbai, Bangalore and Hyderabad. The center will be operational by the end of the year. GE Healthcare is looking at entering the real-time label-free protein interaction analysis market by acquiring Biacore AB for SEK330 per share, an offer that values the company at SEK3.2 billion ($435.9m) or about SEK2.9 billion net of Biacore's cash reserves. ]]> <![CDATA["There should a reciprocal flow of vaccines amongst the countries in the Asia-Pacific region,"]]> https://biospectrumindia.com/news/95/1733/there-should-a-reciprocal-flow-of-vaccines-amongst-the-countries-in-the-asia-pacific-region.html https://biospectrumindia.com/news/95/1733/there-should-a-reciprocal-flow-of-vaccines-amongst-the-countries-in-the-asia-pacific-region.html Wed, 09 Aug 2006 14:28:00 +0530 New Page 1 "There should a reciprocal flow of vaccines amongst the countries in the Asia-Pacific region," -Dr Cyrus S Poonawalla, chairman, Serum Institute of India. Pune-based Serum Institute of India topped the list of "Top 20 Biotech Companies" in the 4th BioSpectrum-ABLE Survey of the Biotech Industry 2005-06 with total revenues of Rs 703 crore, edging past Biocon, the leader for the last three years. In an exclusive interview to N Suresh and Narayan Kulkarni, Dr Cyrus S Poonawalla, chairman, Serum Institute of India, shares his feelings on this development and the company's future course of action. What was your first reaction when you learnt that Serum Institute of India topped the "BioSpectrum-ABLE Survey, 2005-06" as India's top biotech company? It was a pleasant surprise! I was expecting this to happen in 2006-07, but my immediate reaction was to play down the success and that is why we didn't make too much hype out of this very exciting news. Serum Institute has been in the business for over three decades, yet this is the first time that it has been recognized as India's numero uno biotech company in India through a comprehensive survey. How did your staff and stakeholders take this news? As the stakeholders are my family members, there is not much excitement for them. But for the staff members, it definitely is a major morale booster. I, suppose, this would also help us in attracting good, skilled, trained and committed scientists and retaining the best talents, which is a major problem in the biotechnology industry in India. How did your customers, who are spread across the world, react to this development? No, it doesn't make much difference to our customers. Most of the vaccines, which we are related to, are sold to the government agencies-be it in India or globally. These government bodies are not concerned about corporate rankings. The United Nations (UN) agencies have already regarded us as the largest manufacturer of vaccines globally, not just in India. Even they are not keen on the rankings, whether we are the top biotech company or not. However, from the general public perception, my personal standing in the society has naturally been enhanced because of this pleasant news and achievement. And, of course, it would be a major boost for us to hold on to this achievement, if we wished to go for an IPO in the near future-incidentally, we are not considering that at the moment. Serum Institute registered a growth of over 39 percent, as against a growth of 3 percent in 2004-05. What were the factors that contributed for this kind of growth? There are several reasons for this growth. To be honest with you, the growth was flat in 2004-05 because a lot of shipments were not executed owing to various reasons. So it is natural that a part of that-which should have gone in that year to sustain a growth of about 10-15 percent-has came into this year. So this is an abnormal growth. I don't want to take the credit by saying that we did a great job and that is why our growth is about 40 percent. This was one of the reasons. There were a lot of postponements of consignments by our purchasers, possibly due to rescheduling of the dates of their campaigns. And to some extent, even the product. We also had our own share of constraints in sending out the shipments. It is a combination of both these factors, which led to this. And obviously, we are trying to see that this doesn't happen again so that we have a steady growth line. A lot of efforts were put in this year to make sure that the shipments went out in time. So that is major motivating factor to recover the lost ground. The second reason, I think, was that Biocon didn't grow as much as it grew in the past few years. It registered about 6 percent growth. This drastically changed the balance in our favor. Beyond that, we had launched a couple of products during the year in India like Q-Vac, combination vaccine and Td vaccine. And we even stepped up the sales of rabies and a range of other vaccines in India. Which are the products that will give you more returns this year? The combination vaccine that we have launched last year in India, received the WHO pre-qualification only in the last week of July 2006. It is a major milestone for us as ours is the first Indian company to get pre-qualification for combination vaccine from WHO to supply to the UN agencies. We expect the UNICEF and other UN agencies to procure this from us, as this vaccine is in acute shortage worldwide. And only the big pharmas are offering it and at exorbitant prices. Why is there a shortage of availability of combination vaccines worldwide? There are so many global players who are into the manufacturing of DPT and Hepatitis B vaccines but they don't have the pre-qualification from the WHO. It also took us nearly a year to get the pre-qualification from WHO. It is very cautious in giving the pre-qualification certificate. We launched our indigenously developed combination vaccine in India in July 2005 after we completed a rigorous process of following the clinical trials and have supplied a couple of millions of doses of the combination vaccine in India. Why is the big pharma not eager to enter the combination vaccines race? While some of them have the vaccines, others don't. Nonetheless, I think, this product (combination vaccine) doesn't interest them because of the low price realization and they were already aware that the Serum Institute has come out with this product. The big pharma is concentrating on combination vaccine (i.e., pentavalent vaccine), which will give them the value in dollars and not in cents. That is the bottomline. What about the Chinese companies? The Chinese GMP is very poor and I am very much concerned about their biologicals. Only developing countries like India are allowing the products from China to enter their markets. China doesn't allow the Indian vaccines into their market. We are freely allowing their products (vaccines) to come into India and invade our market. This is not a fair and proper-level playing field. The Indian government should take serious note of this so that there should a reciprocal flow of vaccines between the countries in the Asia Pacific region. For example, China is not allowing shipment of Indian vaccines into its territory, though Hepatitis vaccine from China is allowed to be imported into India. And the Chinese are unreceptive on this and use the stick of regulatory issues, to keep Indian products out. The Serum Institute launched Q-Vac, combination vaccine, and Td-Vac, tetanus and diptheria vaccine, in 2005-06. Will Serum launch any new products during the current financial year 2006-07? We are expecting to launch two products this year. The first one will be hemophilia's influenza vaccine. It will be followed by pentavalent combination vaccine (DPT-Hib-HepatitisB) in early 2007. These two are going to be major growth drivers for us. We are also launching Percutaneous BCG vaccine for superficial bladder cancer. What is the potential for these products in the global market? For the pentavalent vaccine, we expect to capture a substantial market from the big pharma. We expect to launch the product at one-third of their price. You will be surprised to know that doctors are encouraging this product and they have indicated to us that we should launch our products just a little below the GSK's price, i.e., double the price of what we would like to launch, and that medical professionals and retail chemists should get huge margins from the manufacturer, a driving force for the product to be marketed. My objective is that my people should get our products at competitive prices and we expect to do better. My marketing people say that we have to sail with the tide. And we slash the prices for supplies to the Indian government. Let us see what best can be done. The sale of these combination vaccines in India and abroad is only going to be through these immunization agencies. The sales from other markets are going to be rather marginal. Should the industry take up with the medical community the pricing issue? I would love the industry to take up the issue. But I don't think they have got the will power to do it as I see, especially the multinationals, because it suits their philosophy. On one hand they cannot lower their prices and on the other, they are still the dominant players globally. The real growth of sale of these kind of products like combination vaccines can only be seen if the government of India includes these products in its national immunization program. It's a great pity and shame that the Indian government has not yet done this, while neighboring countries like Bangladesh, Nepal and Pakistan are introducing all the vaccines including the Hepatitis B vaccine in their national programs. The reason is best known to them. You have already invested Rs 200 crore to set up the Bio Pharma Park, the country's first private sector specific SEZ at Pune. What is the current status of the Serum Bio Pharma Park? On July 27, we got the nod from the government for the installation of the equipment at the SEZ. It will be fully operational from next year. We intend to invest another Rs 500 crore very easily next year on the expansion of the Biotech SEZ. However, there is no clarity on many of the policies, which is hampering the progress. The commerce ministry is right, but the finance ministry is unnecessarily coming in the way. Do you have any plans to have a separate division on clinical research within the Serum Institute to do clinical trials? No. We don't intend to have a separate division on clinical research. In fact, we would like to identify some clinical research organizations, which are dynamic and outsource the business to them. It would be a win-win situation for both of us, as they are more focused on it and give quicker results. What are your strategies in the next 5-10 years in order to become a global biotech player? I have been urged to now look at the US and European markets, as the same products on registration will fetch us a higher realization of 10-20 times the current price of the product. We have been putting in the place, especially in our new SEZ, the infrastructure, which will be of global standards. This is a new thrust area where we have to invest lot of money, time, and resources, as it would be very rewarding. We are also working on some of the products like pegylated version of EPO, a recombinant biotech product and anti-cancer drugs, which will give us an opportunity for diversification from the vaccines business. However, our focus at the Serum Institute will continue to be on the vaccines business. We have also been working on New Drug Delivery Systems (NDDS) in collaboration with the WHO for the last couple of years on measles vaccine through the aerosol route. It is in Phase-III trials in Mexico and India. But it is difficult to say when we will launch this in the market. ]]> <![CDATA["Aim to be among the Top 5 BioClusters"]]> https://biospectrumindia.com/news/95/6156/aim-to-be-among-the-top-5-bioclusters.html https://biospectrumindia.com/news/95/6156/aim-to-be-among-the-top-5-bioclusters.html Wed, 09 Aug 2006 14:17:00 +0530 New Page 1 "Aim to be among the Top 5 BioClusters" India is showing the way to the rest of the world. It is not the volume of business or growth. India is a land of ideas and Dr RA Mashelkar would also like to see those ideas translate into products and technology. Dr Mashelkar in his vision talk at Bangalore Bio 2006 spoke on several things that we can and should do. BioSpectrum publishes those as a ready-reckoner for the industry in first person. India has attracted much attention in the last two years. The interest in India is unbelievable. People are looking at tapping the opportunities in India. In fact, there are new terminologies that are coming up. One is familiar with the history of science but now people are talking about the geography of science, the changing geography of science. People look at creation of a new atlas where the center of gravity of research and innovation is shifting to the Asia Pacific. India and China figure prominently in the discussions. People are so tired of talking about India and China that they call it Chindia. It is obvious as to why this excitement. It was in March 1995 that I gave a Thappar Memorial lecture. It was presided by the then finance minister and now the Prime Minister, Dr Manmohan Singh. The title of the talk was "India's emergence as a global R&D platform: Challenges and opportunities". And I had a very simple premise that I had built in that paper. That was skill-based competition. The real competition is going to be on the basis of skills and that the product is merely going to be a transient. A product is going to be one where the company will derive value by selling it in the market. But how will a company keep the product together will be determined on how one gets the best skills in the cheapest possible way, the smartest possible way, and in the shortest possible time. And based on that I thought India could assume an important position. That was in 1995. There are now close to 200 companies that have set up R&D centers. When the Jack Welsh Center was inaugurated and when Jack Welsh was asked why the center was set up in India, his response was simple- the highest intellectual capital per dollar. He was not talking just about cost, but cost cum competence. He was talking about competence as reflected in intellectual capital and cost as reflected in dollar. For a long time, I wondered how could that be valid. I did a simple analysis a year ago. Suppose one is looking at Science Cited Index (SCI) papers that are peer reviewed. I made a list based on the SCI Papers produced per GDP per capita. For a five-year period, India topped the list with (31) and was followed by China (27) and the US (7). This list was about the maximum scientific output per dollar invested. Clearly, this shows where the investments will go. India is going to have good time in the future. There are 3 Ds, which are responsible for innovation, creative thinking etc-Democracy, Diversity, and Demography (the largest number of young people). These will continue to be our key strengths in the next two to three decades. This window is open to us for some time. Let me come to why one feels optimistic about India. There are many good reasons. India's future is IT (Indian Talent). The second thing is the growth of our economy. India is growing at over 8 percent and India can easily grow above 10 percent. If we are growing like that, we are expanding the internal markets. This is a big advantage with large countries. These are generic advantages. But when we come to biotechnology in particular, there are many things that have happened. The best thing that has happened is Kiran Mazumdar-Shaw. What she has done is transforming her organization from an enzyme producing company to an integrated company. What she demonstrated is that it is not by trade alone that one can grow. One can grow by technology and innovation. Her journey has fuelled aspirations and inspiration. Her role as a visionary has sent strong signals to a lot of young people. I have seen that states are investing in technology. Earlier, this was done mainly by the Centre. Many states are setting up technology parks. It is very encouraging. The industry today is very close to the $1.5 billion mark. The numbers are achievable. But there is a story more than the numbers. Though the numbers are small at the moment, still these mean much more. It is about lilies in pond. They double up everyday. So let us say the pond is full on the 30th day. It is half full on 29th. It is quarter full on 28th. It is 1/8th full on 27th; 1/16th full on 26th (means 6.25 percent full). In other words, it is 94 percent empty till 26th. One would feel skeptical that what can be done but what people fail to realize is that the lilies double. So the numbers will happen. But the question is, will these happen? What is the guarantee for growth? What are the factors that retard growth? We have come a long way. There is plenty of good news. What is important is the direction is right. What we require is direction and speed in making some of these things happen. We need movements. We need to move from Biohype to Biohope. That hope will not happen if careers, entrepreneurs, and jobs are not created and if biofunding does not happen or bioregulations do not progress. We need to move from bioactivism to biorationalism. The 21st Century is going to be the century of hope. Dr Mashelkar's Mantras Top 5 club membership: If India has to gain respectability in biotech, it has to become a member of the big club. Two years ago, India was not there in the list of 17 countries, but now we are making an entry. Our vision should be that we have to be among the top 5 clusters. Resourceful: In order to do that we need to understand that biotechnology is both knowledge-intensive and capital-intensive. Since it is knowledge-intensive, we have to create human capital, which is not only people who understand bioinformatics, cellular or molecular biology, but also those who understand IPR, bioentrepreneurship, clinical trials, etc. It is going to be a big issue. Because it is capital-intensive, I believe the government-institutional partnerships and innovation are going to be important. And in a country which is short of resources, one can move forward by being resourceful like Japan. That will mean smart-policy level initiative. Techno-entrepreneurship: We have two goddesses. The Goddesses of Knowledge and Wealth. Normally they are treated separately and kept together. But there is a route from the Goddess of Knowledge to the Goddess of Wealth. That was how Silicon Valley was created. Somehow we have not understood that. That is where we need to change. Take for example the UK. Prof. Robert May, the president of Royal Society, about 15 years ago in one of his speeches remarked that the UK is fantastic in science and in creating wealth through ideas-but not in the UK but elsewhere in the world. But look now, all that has changed. The temples of knowledge, Cambridge and Oxford, all have changed. About 10 percent of the European Unions' venture capital has been invested in Cambridge enterprise. And over 50,000 jobs have been created. Ten years ago, Oxford put up one start-up company in every four years. Now it spins out one start-up company every two months. In India, we have not got the dynamics of techno-entrepreneurship. There are a few examples like Dr Vijay Chandru of Strand Life Sciences or Dr Padmanabhan Babu of Bangalore (Sanmar) Genei or Dr Ashok Jhunjhunwala of Tenet. What we need to focus on is how do we promote that and how do you make it a rule. This is our biggest challenge. Indian diaspora advantage: India should make best use of the great strength that we have in the form of Indian diaspora. About 2 percent of Indians who are living outside India generate income that is almost equal to the GDP of India. We do not need remittance of the dollars, but what we need is remittance of knowledge. We need to put in place a mechanism that will help us leverage this. Inclusive strategy: It has to be recognized that BT is not an end. It's a means to end. The real end is for the welfare and wealth care. It is the welfare of everyone, by including the vast population. We require expansion of systems and maintaining highest quality and at the same time inclusion of the benefits to vast majority. I have been the vice chair of WHO's commission on IPR, innovation, and public health. Madame Dreifuss, former President of Switzerland, was the chairperson of the commission. We worked for two years together and recently submitted the report to the Assembly. We looked at the entire issue of making diagnostics, vaccines, and therapeutics available, affordable, and accessible to those who are deprived. And there I made an appeal and talked about creating a new global knowledge pool for global good, through global funding, and through new global understandings. New global understanding has to be on the basis of some principles, where we understand the interests of the inventor or the innovator and the interests of the society. That is where we are looking at new models. That is where one is looking at Public-Private-Partnerships (PPP). About 60 percent of the funding comes from the Bill Gates Foundation. It is where the participation of nations is important. That money should also be used for creating the knowledge. Broad Concerns Single window clearance, streamlined approval process A hassle-free and fast regulatory approval is the need of the hour. This could be achieved under a single regulatory authority with two units, one for health biotech products and another for agricultural products. Approval process needs to be streamlined in terms of both timelines and review. For example, a technical committee at the level of Drug Controller General of India (DCGI), for proper review of new products, is needed. This will actually decrease the time lag, which is now due to the referrals to ICMR. This is especially relevant to be considered in case of the novel products which are being worked on more in India now. Streamline the approval process to import and export of biologicals and the samples. A step in this direction has been initiated in the Mashelkar Committee recommendations, but it has to be further simplified in terms of many parallel clearances that the companies need to get. Sector thrust Clinical trials Change in regulations to authorize DCGI to grant permission to conduct Phase-I and Phase-0 studies. Facilitate animal trials: Undue delays and interference by CPCSEA nominees (who many a times are activists) are bottlenecks and roadblocks in generating pre clinical data in animals. The government has to take more positive steps to resolve this issue. Allow commercial export and import of non-clinical trial related biological samples like blood, serum, and plasma for R&D use. Priority clearances at customs for clinical trial medicines since most of the clinical trial supplies are temperature sensitive. Single window clearance for all required approvals to be established. A clear stand by the regulatory bodies on the data exclusivity is essential for the growth of the biotechnology industry. A discussion between officials and experts regulatory bodies pharma/biotech industry and pharma associations could settle this issue. BioAgri Now that the concerns of the BioPharma sector are more or less addressed, the focus should be on setting things right for the BioAgri sector. On one hand there is a requirement to address the GM crops policy and on the other support is needed for the biofertilizers and biopesticide manufacturers and tissue culture companies. The involvement of multiple agencies and multi-tier committees often leads to unnecessary delays and duplication of efforts. For e.g., the testing of agronomic performance both in the Large Scale Trials (LST) and in the Indian Council of Agricultural Research (ICAR) trials is unnecessary duplication of efforts. It can even be argued that the regulatory testing should be limited to assessing the bio-safety and efficacy of the transgenic product. With increasing choices, it should be left to the farmer's wisdom to choose the variety that best suits his/her growing conditions. The formation of the proposed National Biotechnology Regulatory Authority (NBRA) as envisaged in the National Biotechnology Development Strategy document prepared by the Department of Biotechnology could be a single window agency to clear the commercialization of transgenic crops. Further, the implementation of certain policy changes in the regulatory process like gene/event based approval instead of the present variety/hybrid based approval will go a long way in avoiding unnecessary costs and generally in hastening the dissemination of approved technologies. We have many public institutions that have the competence to develop genetically altered crop varieties using all the modern tools that plant biology has to offer. However, very few useful products have been commercialized by these institutes over the years. While project funding needs to be increased, there must be an immediate review of the projects to bring about a focus on products or solutions to specific agricultural problems. There should also be a thrust on networking and meaningful collaborations between the public and private institutions. The biofertilizers and biopesticide manufacturers need support in terms of recognition as an independent industry under National Industrial Classification (NIC) 2004. Be treated as preferential industry and concessions be given. Better infrastructure The government may consider setting up state-of-the-art animal house facility to make available experimental animals including non-human primates, specific transgenic animals, specific pathogen free animals etc. to the industry. cGMP/GLP pilot scale facilities for peptide and recombinant proteins would help to initiate faster pre clinical development of biotech products. These facilities should be made available to the industry, specially the start-ups. Facility for genomic and amino acid sequencing and facility for making available molecular biology reagents at an affordable cost would provide flip to the Indian biotech industry. These facilities could be set up in Biotech Parks. All these facilities could be made available to industry on payment basis. Facilitate clusters on the basis of strengths in a region. Availability of strains of pathogens/antibodies. It is difficult if not impossible to get strains of the pathogens that are available in the government supported research centers. It is even more difficult to obtain strains from "strain banks" established with the support of government funding. The appropriate mechanisms should be put in place where industry can get microbial strains from the "strain banks". The government may consider establishing such microbial strains banks and also reagents banks. Human talent Since Biotechnology is knowledge-based discipline, a clear-cut policy and friendly facilitating system along with incentives to industry and university may be put into place. There may be a need to change clauses in UGC Act so that universities may be permitted to participate in establishing facilities along with industries. This would encourage public and private partnership. Improvement in course curriculum for Masters degree program in Biotechnology so as to have trained manpower relating to molecular pharmacology, molecular biochemistry, molecular immunology, molecular medicine, bio-computational tool, genomic and biotechnologists with the global expertise on information technology and vice versa. Such manpower is essentially needed for the "modern biotechnology industry" and the essential for the growth of this sector. There is dire deficiency in the availability of biotechnologists who are well trained in using cutting edge technologies. Fiscal support Central and state governments may consider setting up venture funds for biotech industries. A dedicated fund by DBT or other agencies meant for establishing startup companies would usher in new biotech industry. The scientists located in the R&D units of the industry should be eligible to obtain research grant from government agencies in a fashion, similar to the scientists who are conducting R&D in government supported research centre(s). Most of the programs of NIH/PHS, USA are open both to industry and academia centre in identical fashion. A similar model could be adopted by funding agencies. Expenditure on R&D and filing of patent needs to be exempted from income tax. This would stimulate new patentable products/processes that are "must" for survival of biotechnology industry. The custom and excise duties on the import of biotech especially on life saving products have been slashed and a further reduction in duties would augment availabilities of biotech products for unmet needs. Similarly, customs and excise duties on the import of reagents required for molecular biology tools including recombinant technology, monoclonal antibodies, etc. need to be slashed at a level equal to import duties for the biotech finish products. There is a need to give more incentives like rebate on the cost of land, concession in stamp duty and in registration charges, exemptions on stamp duty for biotech incubators, and more friendly power tariffs. The incentives like exemptions on payments from entry tax on capital goods, purchase tax, sales tax and work contract tax and availability of uninterrupted power supply, more friendly labor laws and friendly Pollution control regulation are essential for creating good infrastructure for knowledge based industry. The funding agencies may consider devising appropriate mechanisms to safe guard the confidentiality of the innovative research programs submitted by industry for grant/soft loans. The non-existing confidentiality mechanism discourages many biopharma/biotech to apply for grant or for soft loan. ]]> <![CDATA[From BioHype to BioHope]]> https://biospectrumindia.com/news/95/2083/from-biohype-to-biohope.html https://biospectrumindia.com/news/95/2083/from-biohype-to-biohope.html Wed, 09 Aug 2006 14:13:00 +0530 From BioHype to BioHope From BioHype to BioHope In July 2003, BioSpectrum brought out a list of impediments that were coming in the way of biotech boom. Three years hence, a lot has been done to remove the hurdles. The team of Kapil Sibal, union minister for science and technology, Dr MK Bhan, secretary, Department of Biotechnology, Dr Pradipto Ghosh, secretary, Ministry of Environment & Forests (MoEF), Dr RA Mashelkar, director general, CSIR, and Dr NK Ganguly, director general, ICMR, and Prof. MS Swaminathan, UNESCO-Cousteau Professor in Ecotechnology and chairman, MS Swaminathan Research Foundation, have put in concerted efforts to give fillip to the biotech industry. India's stars are just right. India's President is a technologist, the Prime Minister is an economist, and the Science and Technology Minister, though a lawyer, has acquired a strong understanding of the power of science and technology. Now that we have the right constellation, BioSpectrum felt it's time to speak with the industry to find out the next set of priorities for the policy makers and benefit from the present constellation. The response that we got was that there has been a great progress and it is time for the industry to act and move ahead. And now that the industry will be putting its act together and rising, it's time to think big and grow. Think beyond the impediments and move from BioHype to BioHope, in the words of Dr Mashelkar. The industry in the past three years has been growing over 35 percent. People today are looking at India as a major biotech destination. Yet, according to Dr Mashelkar, there are questions he faces regularly like will this continue to happen? What is the guarantee for growth? What are the factors that retard growth? Most CEOs ask as to what can go wrong. Let's look at the ground realities, he told a large gathering of over 200 dignitaries from both India and outside of India, in his vision talk on the lines of Bangalore Bio in June 2006, and took up the list of 10 impediments brought out by BioSpectrum in July 2003 as a reference point. BioSpectrum listed in its July 2003 issue the following 10 impediments: 1. Multiple regulators 2. Wavering on IPR 3. Policy on GM crops 4. Inadequate government support 5. Lack of seed funds 6. No norms for animal trials 7. Lack of appropriate BT education 8. Irritants in clinical trials 9. Infrastructure constraints 10. Weak industry-institute linkages Let's go through each one of these to make a rational decision to find out if India is hot or cold, said Dr Mashelkar, and analyzed. Multiple Regulatory Issues: From April 1, 2006, many hurdles have been taken away. It has been hassle-free way in terms of regulation. As far as agri biotech is concerned, there are still problems. We need to solve them and focus our attention. Wavering on IPR: IPR is a critical. People never thought that India would have product patent laws and comply with TRIPS. But we surprised everyone by complying with it. IPR is no more an issue. Policy on GM products: We continue to struggle. Worldwide also there is a struggle. There are different positions being taken. There are countries, which are permissive. The other extreme is preventive. Both approaches are wrong. What we really require is a promotional but precautionary policy. And in order to achieve that promotional and precautionary approach, we need dialog. That dialog is happening across the world. Inadequate government support: Biotechnology started in the country not because of entrepreneurs but because of the government initiative in setting up what is called the Department of Biotechnology in 1986. Even before that, a National Advisory Board was set up in 1983. The government has created capacity in the last 20 years. Then came the entrepreneurs. But now the prime need is to help support the industry through funding, which is judiciously placed. One totally agrees. The industry wanted Rs 200 crore. But with the new initiatives like the Special Drug Development Promotion fund, which is Rs 150 crore; SBRI, which is set up by the DBT, the New Millennium Technology Leadership Initiative (NMTLI), through which a lot of biotech projects are supported, you will see some headway. Of course one can do more and try newer ways of support. That is a new problem. Lack of seed funds: Our major problem is that the venture capital is not adventure capital. They are so cautious. They are betting on safe products or projects. We need adventure capital. Basically early stage funding is a problem. The SBRI promises to address this issue partly-a type of financing which will make companies ready for venture capital. The government has taken the first few steps and we need to go beyond that. Animal tests are a problem: I do know that Dr P Ghosh, secretary, Ministry of Environment and Forests, is doing his best to make things move. Lack of appropriate BT education: I am concerned about quality. Today, BT has become a buzzword. Education is so valued in India that parents give up everything to send their children for higher education. So we need to see how we can create employable biotech people. We need to work to create quality educational institutions. Irritants in clinical trials: Data exclusivity has been an issue. There has been a divided opinion about making drugs available at the first possible opportunity versus unfair commercialization consideration. So some sort of balance is needed. Things are moving in such a way that we will be able to create that balance. There is the issue about regulator. Among the many Mashelkar committees, there was one on the spurious drugs and also on reforming and revitalizing our regulatory system, that is DGCI. I am very happy to say that the Drug Regulatory Authority of India, which was proposed in that report, is at a fairly advanced stage of discussion with the Cabinet. We have given a completely professional structure. Infrastructure constraints: One talks about access to facilities in national laboratories, universities, etc. This is about public-private initiatives. These are beginning to happen. For example, TCGA at the Institute of Genomics and Integrative Biology (IGIB), which has been formed by the TCG Group and IGIB. Weak industry-institute linkages: There has been a tremendous progress in this direction. For example, the NMTLI initiative. There are 65 companies and more than 200 institutes coming together. These new initiatives are beginning to show results. They are not isolated cases of Public-Private Partnerships (PPP). Actual products are coming out. For example BioSuite, a bioinformatics product, is the outcome of such an initiative between the TCS and institutes. TCS knew making products but had no idea of bioinformatics. There were 19 other institutions, which knew bioinformatics-the aspects and domains-but did not know how to make a product. They were brought together and an investment of $5 million was put in and BioSuite was developed. The key is to get them engaged. The beauty of such models is that these funds are positioning themselves for reasons, which are completely different. Indian industries have worked in the areas where technologies were certain and markets were certain. However, the NMTLI funds are moving into areas where technology is uncertain and markets are uncertain. We cannot do this if one is not prepared to fail and take risks. These funds are such that they can bear the risks. There are new ways of engaging the best of both worlds. Speed and Direction We have come a long way. There is a plenty of good news and what is important is the direction is right. Now the sector needs speed in making some of these things happen. Varaprasad Reddy, managing director, Shantha Biotechnics, observed, "The approval process needs to be streamlined in terms of both timelines and review." Reddy suggests streamlining of the approval process for import and export of biologicals and the samples. "A step in this direction has been initiated in the Mashelkar committee recommendations, but it has to be further simplified in terms of many parallel clearances we need to get," he added. A single window clearance would be the best approach. "I must say we are not really facing any hurdles as such. Growth is largely in our hands now," commented Dr Dhananjay B Patankar, head, biotechnology, Intas Pharmaceuticals. Dr Hemanth Nandigala, director, Virchow Biotech, conferred, "I think we have progressed quite a bit from earlier days. Biotech regulations today appear a lot easier than what they were before. Being a player in biogenerics, I feel proud that India actually leads the world in having defined a pathway for the introduction of biogenerics. If at all, there is a wish from my side, it would be to see them streamlined further and answerable to a single point regulatory authority." Rajesh Jain, joint managing director, Panacea Biotec, observed, "Biotechnology industry in India can became globally competent and can address global collaboration, provided challenges are properly addressed." Data exclusivity, single regulatory authority with two units-one for health biotech products and another for agricultural products, animal experiment approvals, public-private partnerships, and facilitation of start-ups, research, and innovation should be some the prime areas of focus, he said. There are regulatory uncertainties and delays in some areas, felt the bioservices sector. "The regulations are unclear in certain areas like devices, nuclear medicine and herbal. One has to still go through multiple referrals like GEAC and ICMR's multiple departments," said Dr Arun Bhatt, president, ClinInvent Research. "There has to be a change in regulations to authorize DCGI to grant permission to conduct Phase-I and Phase-0 studies," said Dr C Omprakash, manager, regulatory and data management, Clinigene International. Further, there are delays in ethics committees' approvals. Commercial export and import of non-clinical trial-related biological samples like blood, serum, and plasma for R&D use is not being provided at present. This is another area that can be taken up. "Single window clearance for all required approvals should be established," added Bhatt. Another major concern that the CRO sector faces is at the customs clearance. The delays at the DGFT custom clearance creates major issues. Omprakash reasoned, "Since most of the clinical trial supplies are temperature sensitive, priority clearances at customs for clinical trial medicines will be a great help." BioAgri is a sector, which still needs attention. According to Dr Devraj Arya, manager-regulatory affairs, Monsanto India, there is lack of awareness in public as well as in the scientific community and there is opposition from some NGOs with regards to safety. Dr KK Narayanan, president, ABLE and managing director, Metahelix, stated, "The promise of biotechnology in agriculture, especially for an agrarian economy like India, is now widely accepted. Though relatively late in adopting biotech crops, India has done well for a start. It is now important to sustain the momentum of this initial growth so that this technology quickly brings a better life to large sections of our society. Towards this goal, two initiatives are important: one, promote innovative research in the country and two, regulatory reforms." Dr SC Jain, senior vice president, International Panaacea, said, "The manufacture of biofertilizers and biopesticides is a sunrise biotech industry and is receiving the focused attention from the government. But the irony is that this industry has not found any place in the National Industrial Classification (NIC) 1998 and the Updated National Industrial Classification (NIC) (All Economic Activities) 2004, published by Central Statistical Organization, Ministry of Statistics and Programme Implementation, Government of India, New Delhi with the result this industry has been and is being denied the benefits that are otherwise allowed to its counterpart, the chemical industry for the manufacture of chemical pesticides and chemical fertilizers." Dr Rajeev Soni, president and COO, Premas Biotech, said, "Funding and financing, streamlining of clearances, incubator facilities and incentives for start-ups, better airport facilities for cold storage (-70oC and below) of biological perishable items and better infrastructure (continuous power, water and efficient road transport) for setting up biotech units in the country should be taken up on priority." Clearly, the biotech industry has come a long way and it's time now for streamlining processes and focusing on quick approvals. While these will continue to happen, the players in the industry feel they are in a situation today where they can concentrate on their businesses rather that policy issues. ]]> <![CDATA[Management Assists]]> https://biospectrumindia.com/news/95/2475/management-assists.html https://biospectrumindia.com/news/95/2475/management-assists.html Mon, 24 Jul 2006 12:58:00 +0530 Management Assists Skills like team building Management Assists Skills like team building, team working, leadership, decision-making and documentation can be developed through a rigorous management course. Prof. Aparna Rao Academic Co-ordinator Biotech Business Management SIES College of Management Studies, Navi Mumbai The IT bubble arrived, peaked, burst, peaked again and stayed on top. The results speak for them- selves. It's now the turn of biotechnology to follow suit. With its revolutionary findings in vaccine production, stem cell research, Bt cotton, clinical research and genetic engineering etc, biotechnology as a career option is set to scale newer heights. At a global level, companies like Pfizer, Amgen, Wockhardt and many more are taking keen interest in research and development and marketing of biotech products. Biotech companies like Biocon and Serum Institute too are making their mark on the global markets. There arises thus, a new need...the need for specialized biotech business managers. According to a definition, "Biotechnology is the manipulation of organisms to do practical things and to provide useful products." Biotechnology is a unique industry and has its own individual demands, causing exceptional needs for the industry. With a growth rate of almost 37 percent, there is a dearth of managers who understand the specialty and novelty of this field, people trained to tackle issues related to IPR, finance, marketing, personnel in this sector. This requirement of managers specialized in this field of study and management is only increasing. Curriculum Management traditionally known as "the art of conducting, directing" in the 20th century, was defined as "the art of getting things done through people." Today this definition still holds true but one must understand that to get things done from people, it is important for the people to trust the individual. This trust is developed when subordinates, peers and the industry realize that the individual has thorough knowledge about the uniqueness of the business and all its functioning and is a value addition to the industry. For this a candidate needs grooming in managerial skills like team building, team working, leadership, decision-making and documentation. These are skills generally developed through a rigorous course like biotech business management. It is generally found that students with a background in science are good at their work but lack confidence when it comes to dealing with people. Secondly, they are trained to follow instructions in a lab situation, but when it comes to independent decision-making, they're at a loss. A management course would provide something like a finishing school effect. Challenges A management course after graduation or post graduation, poses some challenges for students. Working their way through theory in new subjects like economics, finance, marketing, human resources (HR), organizational behavior, business communication and coping with pure biotech subjects and finding a balance is no cakewalk. And you have the additional responsibility of planning and organizing seminars, placements, student activities, paper presentations to top it all. Students are expected to keep to tough deadlines in external projects since management definitely is not a classroom learning process. However, all this bears fruit as the student emerges a confident young professional, ready to face the orporate world. Prospects Management is an art. A regular management course trains students in areas of functional management. However, some specialized sectors like hospitals, journalism, biotechnology and pharmacy have specific demands related to their industry. A regular HR manager may find it difficult to understand special requirements related to research and development and personnel in these areas. Managers who are from specialized courses like BBM would meet these requirements more professionally. Shamoni Mulay, one of our BBM students at SIESCOMS, who joined this course after her MSc. in Microbiology says: "We as students of PGDBBM, at SIESCOMS are well aware of the initial hurdles we may have to face due to lack of awareness, but we see bright prospects for the biotech sector, and along with it we are prepared to fill the upcoming need for the right kind of managers. We can feel the biotech boom coming our way swiftly. The time is now, the place is here, and this truly is the way to success." By Prof. Aparna Rao   ]]> <![CDATA[Bright Prospects]]> https://biospectrumindia.com/news/95/5839/bright-prospects.html https://biospectrumindia.com/news/95/5839/bright-prospects.html Mon, 24 Jul 2006 12:56:00 +0530 Bright Prospects Bioprocesses are widely used in several fields of commercial biotechnology and have applications in other areas too Bright Prospects Bioprocesses are widely used in several fields of commercial biotechnology and have applications in other areas too. Prof. Smita Lele Course Coordinator, Bioprocess Technology, Foods & Fermentation Technology Department, Institute of Chemical Technology (Autonomous), University of Mumbai Biotechnology encompasses several disciplines. Genomics, proteomics and bioinformatics are some exciting terms. In fact biotechnology is colorful - "red" (medical and pharmaceutical), "green" (agricultural), "blue" (marine) and "white" (industrial and environmental applications). Bioprocess technology mainly comprises two parts-upstream and downstream processing. The upstream processing is mainly related to pre-fermentation steps and production (fermentation, biotransformation or enzymatic reaction). Downstream processing is carried out for isolation and purification of the product. Typically, 50â€“70 percent of the total production cost in classical processes is due to downstream processing. In fermentation that employs recombinant DNA, cost of downstream processing can be as high as 80â€“90 percent. Thus, downstream processing has been identified as a major bottleneck in commercialization of bioprocesses. Recognizing the need for a specialized course in bioprocess technology (BPT), the Department of Biotechnology supported an MTech program at the Institute of Chemical Technology (formerly UDCT, now ICT), Mumbai, in 1993. This program has special emphasis on downstream processing. The program is focused on creating a pool of expert human resource in the field of BPT, suitable for the growing Indian biotech industry. ICT was ranked among the top biotech schools in India in a survey conducted by BioSpectrum in January this year. The analysis of this survey reveals that excellent faculty, exemplary industry relations and outstanding employment track record are our strengths. MTech. BPT course M.Tech (BPT) is a multi-disciplinary four-semester course: two semesters course work and two semesters research project with emphasis on downstream processing. The total seats offered for this course is 30. Students with a Bachelor's degree in chemical engineering/pharmacy/chemical technology with GATE are eligible to apply. The selection is based on GATE and ICT written test and interviews. Student's growth and prospects Biotech is a very broad field and bioprocess technology is a small part of this gigantic field. Because of the design of the course, hard work put in by teachers and students and the need for such trained students in industry, the students are immediately absorbed by the industry. A study has shown that typically 63 percent of the students join the biotech industry and remaining go for higher studies. What kind of jobs does the industry offer? A biotech industry has three basic sections: research and development (R&D), production and quality control (QC). Usually after an M.Tech in BPT, the students get absorbed in the R&D or production departments. A new emerging area is techno-marketing. It is not like the conventional marketing where one is expected to sell a product. Here there is transfer of technical knowledge or skills. For example, a company like Millipore needs a technically sound person who can go to various research institutes or industries to set up the machinery for certain processes and transfer the required operational knowledge to the concerned personnel in that institute/ industry. Higher studies Students who wish to pursue doctoral studies have an option of doing it from India or in some foreign countries. Many of our students are pursuing doctoral or post doctoral studies from renowned universities in America like University of Purdue, University of Rutgers, just to name a few. Besides this, some also join academic institutes as scientists/faculty. The boom in the biotech industry is not any hypothetical word going around, but it is and can be felt by everyone. By Prof. Smita Lele   ]]> <![CDATA[Rewarding Profession]]> https://biospectrumindia.com/news/95/1597/rewarding-profession.html https://biospectrumindia.com/news/95/1597/rewarding-profession.html Mon, 24 Jul 2006 12:55:00 +0530 Rewarding Profession With India becoming a signatory to TRIPS Rewarding Profession With India becoming a signatory to TRIPS, and clinical trials being mandatory to be conducted as per ICH GCP norms, new career opportunities are available for thousands in clinical research. Dr SK Gupta Director General and Dean Institute of Clinical Research (India), New Delhi Clinical research involves organized research conducted on human beings and is intended to provide adequate information on drug use â€“ its safety, efficacy and adverse effects, if any. It is a thrust area for development of new drugs, formulations, delivery systems, dosage regimens, therapies and more. With the advent of high throughput screening, drug discovery programs have speeded up, making clinical evaluation as the rate-limiting step towards final product development. Scope With India having committed to the WTO TRIPS (Trade Related Aspects of Intellectual Property Rights) agreement, the face of the Indian pharmaceutical industry is set to undergo a complete transformation. As per the current scenario in the next few years, many key patents will expire. With new patent laws having come into effect, it will no longer be feasible to replicate drugs from abroad. Hence, innovation will be the key. Major pharmaceutical companies are looking to bring in new pharmaceutical products off the laboratory bench and onto the pharmacy shelves. In order to accommodate this, the industry is all set to upgrade from mere pre-clinical research and development to clinical trials work. Also, every new drug needs evidence from clinical research to support its launch. Thus, whether it is a new chemical entity or an existing drug that is being marketed for new indication, clinical studies have to be conducted. Similarly, launch of new formulations, drug delivery systems or even new fixed dose combination requires clinical data before it can be marketed. Hence, it is obvious that the area of clinical research holds immense scope and promise, as without the supporting data, drug launches are not feasible. An in-depth analysis of the industry also shows that unless serious measures are taken, the clinical research sector will face major lack of professionals, which means clinical research is definitely the next big career as a rewarding profession. What's more, a job in clinical research offers the following incentives too: Excellent remuneration packages Fast-track career growth Breadth and depth of roles and job functions, enabling one to select the area that best matches one's skill sets and interests Opportunities to work overseas. Demand India possesses a significant potential to be the global hub for clinical research. It is also being increasingly recognized as a quality player and preferred partner for global clinical trials. India has several attributes for clinical trial development, such as: Large and diverse patients pool for conducting clinical trials. Availability of medical, pharmacy and science graduates. Excellent infrastructural facilities. Comparative cost advantage. Changes in the patent laws. According to McKinsey report, by 2010 more than 50,000 professionals will be required in the field of clinical research in India alone. Many pharmaceutical and clinical research organizations have already come forward to unlock the vast potential India has and, are conducting clinical trials in India. This means science, pharmacy and medicine graduates can look forward to exciting and rewarding career opportunities in clinical research. Careers in Clinical Research Clinical Research Associate Clinical Research Coordinator Clinical Research Investigator Study Coordinator Data Manager/Biostatistician Regulatory Affairs Manager Clinical Trials Auditor Clinical Project Manager Clinical Research Manager Business Development Manager Drug Safety Associate Medical Writer Trained clinical research professionals will also be in demand abroad. Today, there are more than 2,50,000 positions vacant worldwide. And salaries vary from a minimum of $40,000 per annum for a clinical research coordinator to almost $1,00,000 per annum for a business development manager. To keep pace with the global advances in the field of clinical research, one needs to join a training institute that can impart innovative and intellectually challenging education at the highest academic standards. By Dr SK Gupta   ]]> <![CDATA[Agri Studies in the US]]> https://biospectrumindia.com/news/95/6698/agri-studies-in-the-us.html https://biospectrumindia.com/news/95/6698/agri-studies-in-the-us.html Mon, 24 Jul 2006 12:54:00 +0530 Agri Studies in the US With the most varied study options Agri Studies in the US With the most varied study options, agricultural colleges in the US rank very high in world rankings. Dr (Ms) Vijaya Khandavilli Country Coordinator Educational Advising Services, US Educational Foundation in India (USEFI), New Delhi The study of agriculture traces a unique history in the US. By the middle of the 19th century, demands from public grew for agricultural and technical education. With the passage of Morrill Act in 1862, for the first time in the US, land-grant institutions were set up to teach agriculture, military tactics, and mechanical arts in addition to classical studies. Agricultural and mechanical universities thus set up received further boost through the Hatch and Smith-Lever Acts in 1887 and 1914 respectively. As a result of these Acts, today's land grant institutions have agricultural experiment stations for research purposes and cooperative extension services for dissemination of information gleaned from research. USP In a decentralized system as in the US, especially at the graduate level, eligibility requirements and course requirements can vary a great deal. But in a general sense, students with undergraduate preparation in biology are eligible for agricultural science programs offering specialization in all areas of biological sciences, biotechnology, food sciences, forestry, nutrition, ecology, and environmental sciences. A typical US undergraduate curriculum in agricultural science includes general courses in communications, mathematics, humanities, statistics, and hard sciences like physics, chemistry, and biology. In addition, based on the interest, students opt to study (agri) business, biotechnology, nutrition, human services, environment, food science and technology; (agro) economics, international agriculture, engineering, education, the list goes on. Types of degrees International students are often perplexed with the variety of degrees that are offered in US universities. Graduate programs lead to Master of Science, Doctor of Philosophy and a variety of professional degrees such as Master of Agriculture, Agricultural Education, Forestry, Food Science, Human Nutrition. Professional degree programs are suitable for students who desire an intensive education in the chosen specialization; who are already in a professional career, but desire to upgrade their skills and knowledge. Master's degrees usually are on both thesis and non-thesis bases and Doctor of Philosophy degrees require a thesis or a dissertation. Students who have doubts if PhD is a good option for them should apply to departments that can award terminal master's degrees on partial completion of a doctoral program. Degrees may be earned in departmental and interdepartmental programs within the college and in interdisciplinary programs with other colleges in the university (College of Agricultural Sciences, Penn State University). Interdisciplinary programs provide the student an excellent combination of educational programs and a broad range of experience. Students can take minors in interdisciplinary programs as well as in other departments of the same university. In land-grant institutions, the colleges of agriculture carry out research and extension education programs across the state on contemporary societal issues.   Specializations Agricultural Sciences Alabama Agricultural and Mechanical University, AL Colorado State University, CO Louisiana State University and Agricultural and Mechanical College, LA Agricultural Sciences - Agronomy and Soil Sciences Mississippi State University, MS North Carolina State University, NC Oklahoma State University, OK Utah State University, UT Agricultural Sciences - Animal Sciences Brigham Young University, UT Louisiana State University and Agricultural and Mechanical College, LA North Carolina State University, NC Southern Illinois University Carbondale, IL Texas A&M University, TX Utah State University, UT Agricultural Sciences - Environmental Policy & Resource Management National University, CA North Carolina State University, NC University of Missouri, St. Louis, MO Agricultural Sciences - Food science & Technology Cornell University, NY Drexel University, PA Illinois Institute of Technology, IL North Carolina State University, NC University of Nebraska â€“ Lincoln, NE Agricultural Sciences - Forestry Michigan Technological University, MI Oklahoma State University, OK Oregon State University, OR Agricultural Sciences - Horticulture Louisiana State University and Agricultural and Mechanical College, LA University of Florida, FL University of Wisconsin, WI Specializations galore A survey of graduate agricultural programs reveals a vast variety of sub-specializations. Some of them are: animal breeding, aquaculture, basic and clinical human nutrition, biochemistry, biological and agricultural engineering, biological statistics and computational biology, biomathematics, botany, crop science, crop and weed sciences, dairy science, ecology, entomology, environmental pollution control, fermentation, fisheries, food industries, food microbiology, food safety, food technology, forest resources, genetics, genomic sciences, horticulture, immunology, integrative bioscience, integrated pest management, landscape architecture, marine sciences, microbiology, molecular and cellular biology, natural resources, nutrition, pathobiology, plant breeding, plant pathology, plant physiology, poultry science, toxicology, tropical agriculture, vegetable crops, wildlife biology, wildlife ecology and conservation, and zoology. The list seems endless. Selection of an institute Availability of such a vast variety of programs often poses the "problem of plenty," to international students. The basic advice is to select the program that best meets one's academic and professional requirements and not merely go by the name of the university. Following are a few recommended criteria to consider while selecting programs: Professional accreditation: It is important to see if the program has professional accreditation (not all specializations, however, have professional accrediting bodies). Examples are: Forestry programs are accredited by the Society of American Foresters; nutrition and dietetics programs are accredited by Commission on Accreditation for Dietetics Education (CADE) of The American Dietetic Association ; Landscape architecture (Horticulture) programs are accredited by The Landscape Architectural Accreditation Board (LAAB). Faculty profile: Faculty with diverse academic backgrounds; international exposure; and in adjunct capacity from industry and research organizations are important criteria to consider. Such diverse faculty with a broad set of interests ensures students find appropriate mentors to guide them through their research programs; offer professional networks; and useful career advice. For example, biotechnology program at UC Davis , housed in the College of Agricultural and Environmental Sciences has faculty from Departments of Agronomy and Range Science; Animal Science, Environmental Horticulture; Food Science and Technology; Land, Air and Water Resources; Plant Pathology; Pomology; Vegetable Crops; Viticulture and Enology; and the Division of Biological Sciences. Diversity in the classroom: It is also important to choose programs that admit students from diverse academic backgrounds. Discussions with such diverse groups of students will help design challenging research activities that incorporate a variety of perspectives to the problems. Similarly it is important to choose programs that admit students from diverse geographical and cultural backgrounds. When combined with the international experiences of the faculty, this offers enhanced opportunities to enrich one's knowledge of other cultures and gain insights into the status of scientific inquiry at the international level. Professional activities and clubs: Going by the philosophy that learning is not limited to the classroom, graduate students should look for opportunities for fellowship and develop their organizational and leadership skills through participation in professional clubs such as Food Science Clubs / Food Product Development Team; Graduate Student Association and Leadership Development Seminars (ex: North Carolina State University and University of Nebraska â€“ Lincoln) Cross-registration: Ability to register for courses not only across various departments within a university but with different universities in the locality enhances the learning and professional exposure. For example, Biosystems engineering program of the College of Agriculture, Forestry, and Life Sciences at Clemson University is jointly administered with the College of Engineering and Science at Clemson University. For a full list of interdepartmental graduate programs, please visit http://www.clemson.edu/CAFLS/. Similarly, students of North Carolina State University can take courses at other universities of the research triangle such as Duke and University of North Carolina at Chapel Hill. Partner departments, agencies and associations: Donald Danforth Plant Science Center partners with The Missouri Botanical Garden with informatics capabilities in tropical and temperate plant research, Purdue University, West Lafayette, Indiana, The University of Illinois at Urbana-Champaign, The University of Missouri-Columbia â€“ three land grant universities, Washington University in St Louis with historical strengths in plant sciences, Monsanto Company, a leading global provider of agricultural products and integrated solutions for farmers. Boyce Thompson Institute for Plant Research at Cornell University partners with The Boyce Thompson Southwest Arboretum in Superior, Arizona, Cornell University, MicrobeWorld on their 90-second programs on air, The National Agricultural Biotechnology Council (NABC) and the United States Department of Agriculture (USDA). The Illinois-Missouri Biotechnology Alliance (IMBA) is a joint program of the University of Illinois and the University of Missouri and is funded by a Congressional Special Grant administered by the United States Department of Agriculture (USDA). The purpose of IMBA is to fund biotechnology research that is an integral part of a Research and Development (R&D) program directed at expanding the volume of profitable businesses in the United States (US) food and agricultural sector. Iowa State's biotechnology program links university and industry research through a biotechnology industrial liaison. The liaison, funded by the Office of Biotechnology, works with industry and faculty to build collaborations between the sectors and to bring Iowa State technologies to industry and local economic development groups. The Center for Crop Utilization Research (CCUR) and the Center for Designing Foods to Improve Nutrition (HNC) are affiliated with the Department of Food Science and Human Nutrition at Iowa State University . Rutgers University's program in Food Science has an industrial advisory board, which includes senior executives of major food companies, thus providing an additional dimension to the program activities. It also has the Center for Advanced Food Technology (CAFT), one of New Jersey's high-technology centers, providing a valuable complement to the graduate food science program. College of Agriculture and Life Sciences (CALS) at University of Florida participates in research programs of the Center for Tropical Agriculture, the Center for Latin American Studies, the Florida Water Resources Research Center, the Center for Biomass Energy Systems, and the Florida Sea Grant College Program. Programs in non-bioscience areas Programs in Home Economics; Human Sciences New Mexico State University, NM Texas A&M University, TX Prairie View A&M University, TX Tarleton State University, TX   Programs in International Agricultural development; rural development University of California, Davis, CA Cornell University, NY   Programs in Horticulture and Landscape Architecture Oklahoma State University, OK University of California, Davis, CA   Programs in Environmental Sciences; environmental resources and policy North Carolina Agricultural and Technical State University, NC Southern Illinois University, IL University of California, Santa Barbara, CA   Programs in Family and Consumer Sciences Southern University and Agricultural and Mechanical College, LA   Program in Agricultural leadership University of Georgia, GA University of Nebraska â€“ Lincoln, NE   Program in Community Development University of Vermont, VT The Ohio State University, OH   Program in Workforce education and development Southern Illinois University, IL Louisiana State University and Agricultural and Mechanical College, LA   Program in Agricultural business West Texas A&M University, TX Alabama Agricultural and Mechanical University, AL California Polytechnic State University, CA New Mexico State University, NM North Carolina Agricultural and Technical State University, NC South Carolina State University, SC   Employment Scope for employment for agriculture graduates is primarily with the government. This could be in research, teaching, standards and quality control and policy making. Rapid advances in biotechnology in the last couple of decades have opened up research opportunities in many areas of agricultural and food sciences in agricultural service companies, commercial R&D labs, pharmaceutical and energy sectors, seed producers, and food product companies. Dr (Ms) Vijaya Khandavilli Note: The aim of this article is to give students a general picture of agricultural study in the US and to discuss in detail agricultural programs that offer opportunities for biology and biotechnology students. The programs and institutions mentioned in the article are only for indicative purposes.   ]]> <![CDATA[Tool Makers]]> https://biospectrumindia.com/news/95/2636/tool-makers.html https://biospectrumindia.com/news/95/2636/tool-makers.html Mon, 24 Jul 2006 12:51:00 +0530 Tool Makers A practical course curriculum will help students take up challenging jobs successfully Tool Makers A practical course curriculum will help students take up challenging jobs successfully. Dr Arun Adsool Principal, Vidya Pratishthan's Art, Science and Commerce College, Baramati Dr Sushama Chaphalkar Director, Vidya Pratishthan's School of Biotechnology, Baramati. Training in biotechnology is a buzzword these days. Every academic institution would like to plunge into opening up doors for biotechnology training in India. Very often we face questions like: What will be the course curriculum? What kind of job prospects are in store for biotechnologists? And so on and so forth. We have started believing that learning is the fundamental requirement for earning. To put it more emphatically, higher the quality of learning, higher will be the earnings. The IT boom has successfully confirmed the hypothesis. In these circumstances, the awareness about biotechnology training and research, development and industry, social impacts and solutions is very very low. Biotechnology is the interdisciplinary approach towards learning life sciences along with physics, chemistry, computer science, maths and statistics. The crucial part is to convert this scientific knowledge into a viable technological base. Scope of biotechnology What is this technology we are referring to? Where is it required? Biotechnology is a very specialized segment of the life sciences industry. The pace of growth of this industry has definitely been accelerated in the 21st century. The growth of biotechnology in sectors, which touch the human requirements on food, health care and environment. This is so very self-explanatory that these three segments of life are the most vital areas of human civilization in the globe at this point of time. It would be rather difficult at this stage to define the scope of this subject in a confined sense. Innovation, value addition, validation, formulation and application - individually or cumulatively define the scope of biotechnology in the vital areas of medicine, agriculture and environment management. Having these as base line statements, we can definitely predict how the course curriculum and its successful implementation can put the man and machine in place to further the most challenging subject of 21st century. Essentially the course curriculum will train a meritorious and interested student, preferably with research acumen in the fundamental sciences with further application in biotechnology. The student would be then trained with practical aspects of modern biotechnology namely plant and animal tissue culture, fermentation and genetic engineering. Sounds good. However, there is a word of caution here: This collage of information from various disciplines of science should culminate into a strong knowledge based meaning biotechnology. To make these work rigorous hands on training in the fundamental techniques is absolutely essential at the graduation level. This exercise is a definite upgradation of the otherwise compartmentalized and repetitive science education at college level. Usually higher education till graduation does not encourage creativity in the present circumstances. Biotechnology definitely would prosper with creativity as one of the main anchors. Independent project handling at the last year of graduation definitely helps the students to be more organized in designing the experiments, logically interpret them and find out what was the most worthwhile activity in the whole series of experiments termed as projects. The students with these ideas would definitely contribute as tool makers in industries harboring new technologies related to Genomics. The Genomic industry can be categorized into five groups: Tool makers: Companies which supply the necessary equipments for gene discovery. Gene cataloguers: Companies which use these tools to build databases and sell them eventually. Target screening: Companies that use these tools to perform target screening. Companies using data bases and developing potential drug compounds as well are known as functional genomics companies. Companies involved in data mining, genotyping, DNA sequencing are using bioinformatics to a large extent. All these developments are signals that the existing major pharmaceutical companies would soon evolve as part pharma, part biotech companies and this forms a biggest chunk of job opportunities for biotechnology-trained graduates, post-graduates and researchers in that order. It is true that the industry would require one PhD and ten bench workers. Hope we can make deliberate effort to maintain this ratio. Farm sector The agriculture sector all said and done needs to metamorphosized into a more scientific and knowledge based industry than a weather dependent, unskilled livelihood. Working with Vidya Pratishthan in rural background has made us realize the need to create awareness amongst relevant target population, actual successful implementation of modern biotechnology at grassroot levels (farmer) and strengthening research based for future needs of agriculture is of utmost importance for a stable and progressive Indian economy. Trained manpower in biotechnology can change this scenario positively. There are other areas of environment management where user-friendly biotechnology can be put to test. It would be wrong to assume that only molecular level studies mean biotechnology. Any positive modification in biological sample further exploited for betterment of human life in any aspect can be deduced as the real meaning of biotechnology at least in the Indian context. India has a unique advantage in its large and diversified genetic resource to lead the world in biotechnology. Trained manpower is required in patent regime as well. This would mean a very interesting scope with a combination of science and law. Talent pool In this era of biogenerics, contract manufacturing, contract research, clinical trials, diagnostics, bioinformatics and agri biotech skilled manpower in these niche areas of biotechnology would have tremendous demand. The potential of growth would depend on pace of innovative mind and the caliber of the manpower entering into this field. Other crucial success factors like infrastructure, patent regime, collaborations with research and development, finances and regulatory support, if fall in chain, India would be undoubtedly at the top in the near future. By Dr Arun Adsool and Dr Sushama Chaphalkar   ]]> <![CDATA[Government ups support]]> https://biospectrumindia.com/news/95/1627/government-ups-support.html https://biospectrumindia.com/news/95/1627/government-ups-support.html Mon, 24 Jul 2006 12:43:00 +0530 Government ups support Government ups support "This year we have evolved the system for medical professionals and now we are working on the other areas. This requires a lot of consultation with the user department. The core of the strategy is to create a pool of jobs." -Dr MK Bhan, secretary, DBT The DBT Foundation Day celebrations, held in March this year, brought happy tidings for the student community. The union minister for science and technology, Kapil Sibal, took the occasion to announce a series of initiatives to enthuse students for higher studies in life sciences. The package announced by the minister included assistance of Rs 50-Rs 60 lakh to select undergraduate colleges in life sciences. The ministry plans to support 20 undergraduate colleges across the country, one per state, for high quality teaching in life sciences. There is also a proposal to award 1,000 undergraduate scholarships of Rs 500 per month for meritorious students from economically weaker sections to pursue career in life sciences. In addition, there will be a fellowship of upto $2,000 per month for post doctoral students wanting to do research in the high tech areas of stem cell technology and nanobiotechnology. There will be about 25 such special overseas fellowships. DBT Fellowship Within the country, the Department of Biotechnology has started a novel "DBT-Junior Research Fellowship" for pursuing PhD in any university/institute. It has launched "BET" or "Biotechnology Eligibility Test" on the lines of the National Eligibility Test (NET) for pursuing research in frontier areas of biotechnology and applied biology. The selected candidates can avail of the DBT-Junior Research Fellowship. The fellowship as JRF/ SRF will be in the range of Rs 8,000-9,000 per month and a research contingency of Rs 30,000 per year. The BET will be a written admission test, which will be conducted in April every year at five different centers, namely Anna University (Chennai), Sri Venkateshwara College (New Delhi), West Bengal University of Technology (Kolkata), Hyderabad Universore and University of Pune (Pune). Summer projects To provide a flavor of research to young students, the DBT aims to extend summer project support in diverse fields (medicine, life science) on a very large scale. The department is planning to promote the summer projects in a big way, irrespective of disciplines, under a mentor. The students will be able to take a 2-3 month project during their summer vacation and some of these may extend and continue beyond this time frame. Giving the rationale behind this move, Dr MK Bhan, DBT secretary, said, "This is based on the feedback from a lot of scientists that early exposure to research thinking is of profound importance in the formative years. Eventually great scientists are not the ones with the greatest grades but they are people who have experience in pursuing intellectual curiosity and if they are temperamentally driven to it then they will be hooked to research. This can be done only in the formative years." New courses Starting from 2007, the DBT will support some new courses which include a Masters program in health sciences, PhD in health sciences and a Masters program in clinical sciences. These courses are aimed to groom physician researchers. "This year we have evolved the system for medical professionals and now we are working on the other areas. This requires a lot of consultation with the user department. The core of the strategy is to create a pool of jobs as there is no point of creating people in an area if the institutional career structure does not exist", elaborated Dr Bhan about the new courses on the anvil. Another noteworthy initiative mooted by the department for strengthening the educational institutions is the beginning of "Institutional Innovation Grants Scheme", whereby the DBT will consider proposals for innovation grants managed by the institutes themselves for students at all levels. These measures will definitely help students aspiring to pursue biobased sciences. Rolly Dureha ]]> <![CDATA[Suppliers' Business continues to boom]]> https://biospectrumindia.com/news/95/2004/suppliers-business-continues-to-boom.html https://biospectrumindia.com/news/95/2004/suppliers-business-continues-to-boom.html Wed, 19 Jul 2006 13:05:00 +0530 Suppliers Suppliers' Business continues to boom Indian life science suppliers business grows by 40 percent. With the Indian pharma and biotech companies focusing on increasing their R&D spend and expanding their manufacturing capacities, the life sciences suppliers industry is growing in line with the biotech industry. India has been one of the fastest growing regions for several leading global suppliers. Global majors like Agilent, Waters, Sartorius, Shimadzu, Millipore, and Pall are growing their bases here and are also expanding. Some are even setting up their R&D facilities in India The total business of the suppliers to the Indian life sciences industry in 2005-06 is estimated at Rs 1725 crore, up by 40 percent compared to the 2004-05 total of Rs 1,230 crore. In 2004-05 four companies for the first time crossed the Rs 100 crore mark. In 2005-06, six companies-Thermo Electron, Lab India, Waters India, Spinco Biotech, Becton Dickinson India, and Agilent Technologies have achieved this feat. In 2006-07, 10 companies are expected to reach this mark. Thermo Electrom with total sales of Rs 172.44 crore tops the life sciences suppliers business recording close to 71 percent growth. Previous year's leader Lab India ranks second with total sales of Rs 163 crore to the life sciences sector. Waters India with estimated revenues of Rs 160 crore from sales to the Indian life sciences companies and institutions is ranked third. Spinco Biotech is in the fourth position with revenues of Rs 138.80 crore. Becton Dickinson India with revenues of Rs 113.9 crore and Agilent Technologies with revenues of Rs 104 crore are ranked five and six respectively. Among the Top Five players, three-Thermo Electron, Waters, and Becton Dickinson are major global vendors, with direct operations in India. In fact eight of the top 10 suppliers are global majors. Only two Indian distributors fall in the list of Top 10. With over 800 products being supplied to the industry, it is difficult to analyze the market for each product category. Here, we attempt to present some of the key segments in the suppliers business. HPLC business The High Pressure Liquid Chromatography (HPLC) market in India is growing at 10-12 percent. Today's HPLCs suit many applications including separation, identification, purification, and quantification of various compounds. In India, Agilent Technologies, Shimadzu, Thermo Electron Corporation, and Waters are the major suppliers of HPLCs. This is a high value business. While MNC HPLC systems cost between Rs 10-18 lakh depending on the configuration and customization, HPLCs manufactured locally are available for Rs 7-8 lakh. This is clearly the reason for the MNC companies to be among the top 10 life sciences suppliers in India. Spinco Biotech, a Chennai-based company, is the major distributor of Shimadzu HPLCs. Over the years, Spinco has established an installation base of more than 4000 Shimadzu HPLC systems. It is estimated that over 1500 HPLC units have been sold. The HPLCs market is estimated at about Rs 270 crore in India.The industry expects HPLCs business to grow more than 35 percent in the next 3â€“4 years. Fermentors The fermentors business is growing at 20 percent. Alfa Laval, Sartorius, Scigenics India, Chemito Technologies, New Labs and Bioengineering are some of the key suppliers of fermentors in India. Scigenics India, a Chennai-based company, which designs and manufactures fermentors and related equipment has one of the largest installed base of fermentors in the country. Scigenics has got the recognition of Ministry of Science and Technology for its research and development unit. Among the global majors, Sartorius has a strong presence in India with its BIOSTATer, a compact autoclavable laboratory fermentor/ bioreactor system. Alfa Laval is another leading name in the fermentors bsuiness. Cell culture Alfa Laval, Cambrex, Corning Life Sciences, HiMedia Labs, HyClone, Invitrogen, and Sigma Aldrich are some of the major global players offering a range of products and services in cell culture space in India. It includes vessels, media, fermentation equipments, reactors, lines etc. Most of them have direct presence in the country. Sigmaâ€“Aldrich offers animal component-free media (for CHO, hybridoma, HEK 293 cells, stem cells) for protein or antibody expression, gene therapy and tissue engineering applications. HyClone is a global supplier of cell culture and bioprocessing systems for application in research and production. Mumbai-based HiMedia Laboratories has developed its own technology for manufacture of the cell culture media. It manufactures and supplies cell culture media, sensitivity discs and allied products. Pune-based Alfa Laval India offers a range of solutions to cell culture-processing needs. Corning Life Sciences offers a range of products in cell culture space like dishes, flasks, microplates, transwell permeable supports, and cryogenic vials. The market for cell culture media in India is about Rs 20 crore. Centrifuges There are more than 20 companies that are into manufacturing and supplying centrifuges. Jainsons (India), Zenith Glasswares and Instruments, Pawan Brothers, Chemo Fab Industries, PK Chemicals and Scientific Co. REMI Instruments, and Sterling Manufacturing Co are some of the companies involved in the production of different types of laboratory scale centrifuges. Automed Systems, Axygen Scientific, Biocon Technologies, Biotech India, Genetix Biotech India, Imperial Biomedics, JH Bio Innovations, and Medi Spec Instruments India are some of the leading supplirs of centrifuges in India. The market for centrifuges has been growing at around 35 percent. The market for small laboratory centrifuges is about Rs 100 crore with over 20 players. Distributors have a major market share. Alfa Laval, Sartorius, Thermo Electron, and Westfalia Separator are major global names with direct presence in India. Informatics The market for Laboratory Information Management Systems (LIMS), software tools that help automate the collection and management of the data generated in a laboratory, too is too is opening up. While Kolkata-based LabVantge, Ocimum Biosolutions, Persistent Systems and Chennai-based Agaram Industries are some of the Indian players offering LIMS products, large multinational companies like Agilent, BioRad, Perkin-Elmer, Thermo Electron Corporation, and Waters are also offering informatic products. In fact most of these big players are now focusing on providing end-to-end solutions for labs. The informatics market according to industry estimates is growing at about 30 percent. Hybridization ovens Hybridization ovens are fast becoming the preferred method of hybridization technique in today's laboratory. Though a few companies in India manufacture hybridization ovens, most of the requirement is met by multinationals. Neolab Instruments, Nu Tek Instruments, and Shambhavi Impex are a few local manufacturers. Other major players include Affymetrix, Amrex, Centurion, GE Healthcare, Techny, and Thermo Electron. MediSpec and Spinco Biotech are the major distributors. ]]> <![CDATA[Connexios outsources literature curation to Molecular Connections]]> https://biospectrumindia.com/news/95/2111/connexios-outsources-literature-curation-to-molecular-connections.html https://biospectrumindia.com/news/95/2111/connexios-outsources-literature-curation-to-molecular-connections.html Sat, 15 Jul 2006 10:51:00 +0530 Connexios outsources literature curation to Molecular Connections Molecular Connections will be carrying out scientific literature Connexios outsources literature curation to Molecular Connections Molecular Connections will be carrying out scientific literature mining for Connexios to assist the latter in its high throughput experiment validation and target discovery purposes. As a part of the agreement, the existing literature mining team at Connexios would be taken over by Molecular Connections. Molecular Connections, would use its proprietary workflows and technologies and its long standing experience in manual curation of biomedical literature to create customized pathway information for Connexios. This would also allow Connexios to focus on its vision of being a discovery led life-sciences company. Connexios also possesses a state of the art wet lab with cell-based assay design and high throughput target identification facility, and a knowledge-driven systems biology platform which would not be a part of the deal. Jignesh Bhate, CEO, Molecular Connections said, "Molecular Connections has come out as a clear leader in the field of high quality curation for protein interactions and pathway biology. The collaborations with Connexios is sure to open new frontiers in establishing technology partnerships across both the companies." Dr Venkatachalam Suri, CEO of Connexios said, "We evaluated many literature curation vendors and found Molecular Connections a quality conscious company with a strong technology platform, a proven track record and high ethics." GEAC rubbishes claims linking Bt cotton to sheep death During its recent meeting, the Genetic Engineering Approval Committee (GEAC) studied and discussed the mortality in sheep flocks after grazing on Bt cotton fields and strongly refuted the association of sheep deaths with the planted Bt cotton, as claimed by the Center for Sustainable Agriculture (CSA), an Andhra Pradesh-based organization. According to the CSA report, in three random villages surveyed at Warangal in Andhra Pradesh, "It was found that animals fed continuously on Bt cotton for up to a week became listless with erosive lesions in the mouth, nasal discharge and blackish diarrhoea." However, after reviewing the case and the available data, the GEAC officials opined that the report appears highly exaggerated and is based more on hearsay than on scientific facts. The committee stated that the Bt cotton released for commercial cultivation has been approved after evaluation of biosafety data, which includes feeding studies. The 90-day animal feed studies conducted at the Industrial Toxicology Research Center, Lucknow, feeding studies conducted at the GB Pant University of Agriculture, Pantnagar on lactating cows and on fish at Avian Research Institute, Izatnagar indicated no toxic effect. Now the regulators have recommended that DBT, the nodal biotech agency, may sponsor a study to assess the problem at Warangal district with the help of the local veterinary hospital. To incorporate further safeguards, in future, leaf toxicity studies will to be included as part of the biosafety studies, the committee stated. It has further decided to refer the matter to the state department of agriculture for a factual report on the allegation made by the NGOs and the findings of the post-mortem report. According to the the acute oral toxicity study of Bt protein in mice conducted at Agriculture Group/ Environmental Health laboratory, USA, there was no treatment-related adverse finding in any of the groups administered B.t.k. HD-73 protein (Bt protein) by oral gavage at dosages up to 4200 mg/kg. The oral LD50 for B.t.k HD-73 (Bt protein) protein in mice is greater than 4200 mg/kg and the no-observed effect level is 4200 mg/kg. Further mice gavage studies have shown that an intake of 4300 mg Cry1Ac / Kg body weight had no ill effect on the mice. Assuming a similar upper safe limit for goats, in order to have an intake of 4300 mg. of Cry1Ac/Kg of body wt., the sheep should eat (assuming the sheep weighs 15 kg) 24,339 kg of leaf/50,300 kg of boll rind, which is not practically feasible. New groundnut variety a boon to farmers The chief minister of Andhra Pradesh, Dr YS Rajasekhara Reddy, presented the groundnut variety ICGV 91114 developed by the International Crops Research Institute for the Semi-Arid Tropics (ICRISAT) to the farmers of Anantapur district at a function organized at the Patancheru campus of ICRISAT recently. Congratulating ICRISAT for developing ICGV 91114, Dr Reddy said that the new variety would help the Anantapur farmers obtain a higher groundnut yield even while withstanding a longer drought. The new variety will improve the income of the farmers of the district, while protecting them from drought risk. Dr William Dar, director general of ICRISAT, said, "It is a strong example of science with a human face, where the farmer of the semi-arid tropics decides what research product he wants from us." Trials conducted by ICRISAT scientists with farmers' participation show that ICGV 91114 yields on an average around 10 percent (range 5 â€“26 percent) more than TMV 2, the variety currently popular in Anantapur. Under good management conditions in the rabi season, ICGV 91114 can yield 2.5 to 3.0 tons per hectare. ICGV 91114 matures early, is tolerant of mid-season and end-of-season droughts, has an average shelling turnover of 75 percent, has an average oil content of 48 percent, and has better digestibility for livestock. The groundnut breeding team from the Institute worked with the farmers to select the most suitable varieties, and together they selected ICGV 91114. The other partners in the project were the Acharya NG Ranga Agricultural Research University and the Rural Development Trust, an NGO. To strengthen the delivery mechanism for ICGV 91114, the Agri-Business Incubator (ABI) at ICRISAT is partnering with Aakruthi Agricultural Associates of India (AAI) - a group of entrepreneurs operating agri clinics - and the Andhra Pradesh State Seed Development Corporation (APSSDC), the state government institution mandated to reach seeds to farmers. Kalam dedicates new cancer drug The President of India, Dr APJ Abdul Kalam recently dedicated to the nation, India's first indigenously developed monoclonal antibody, BIOMab TM EGFR (Epidermal Growth Factor Receptor), developed by Biocon Ltd. The monoclonal antibody assumes great significance from the point of view of its cost-effectiveness. The company joins the exclusive league of monoclonal antibody developers worldwide and aims to be a key player in this segment in the coming years. Biocon's new cancer drug will also be effective in several other cancers that express EGFR, including colorectal, pancreatic, metastatic breast, non small cell lung and brain cancers. BIOMAb EGFR is indicated for use in combination with radiation therapy / chemotherapy in patients with positive expression of EGFR in squamous cell carcinoma of head and neck cancer. Dr Kalam also inaugurated Biocon Park, India's largest integrated biotech hub. Biocon Park comprises of an integrated cluster of research laboratories and manufacturing facilities laid out on a 90-acre expanse in KIADB (Karnataka Industrial Areas Development Board) industrial estate in Bommasandra Industrial Area - Phase IV. Built with a total investment of Rs 650 crore, with further investments to follow, Biocon Park is the single largest capital investment made by the company in its 27-year history. Biocon Park is focused on exports of both bio-pharmaceutical products and research services. Kiran Mazumdar-Shaw said, "Biocon Park, India's largest integrated bio-tech hub is a manifestation of a vision we once had. It is indeed an honor for us at Biocon to have the none other than the President dedicate our cancer drug the nation." India, UK sign agreements of intent on IPR and science India and the UK have signed a joint statement of intent to create and implement an intellectual property rights program between the two countries. The statement was signed by Commerce and Industry minister, Kamal Nath on behalf of India and the UK Science Minister, Lord Sainsbury during the India-UK Business Leaders Forum meeting at London recently. Delivering his keynote address at the meeting, Nath said both India and the UK have become partners of choice in science, technology and innovation because both recognize their importance in prosperity and quality of life. Intellectual property rights is one of the key areas identified by the UK-India joint economic and trade committee as providing potential for increased trade and investment in future. Both the countries have also set up a new Indo-UK science and technology innovation council to promote collaboration in innovation, Science and Technology Minister, Kapil Sibal said. He said that focus of the council would be on strategic areas of next generation communication technologies, biotechnology and stem cell research and advanced materials and nanotechnology. "The council will also work on key initiatives including new energy and weather systems, and climate change, thus looking at developing and delivering new products to the market," Sibal added. He said three leading scientists each from India and the UK would work on a road map to further Indo-UK partnership through these strategic and bilateral initiatives. From the Indian side, the names of noted scientist Dr CN Rao, CSIR director general, Dr R A Mashelkar and DST secretary, Dr Ramaswamy have been proposed. Sibal announced that the best of Indian and the UK scientists and institutions will collaborate with a funding of £8 million pounds which could go up to £12 million pounds with a matching grant from India. The Joint Economic Trade Committee (JETCO) will also be linked with the science and technology innovation council, he informed. Praj net profits rise to Rs 32 cr The Board of Directors of Praj, the global ethanol technology company, took on record the audited financial results for the FY 2005-06. Praj recorded sales of Rs 267 crore (Rs 235 crore) with a PBT of Rs 32 crore (Rs 28 crore). The company has improved performance in terms of EBIDTA margins which are at 13 percent as compared to 12 percent in the previous fiscal. "We plan to improve the EBIDTA margins further. This will happen with more business from international markets wherein Praj will leverage its technology and engineering expertise With all the five plants having been handed over in Colombia, South America, recognition for Praj's technology and execution has been clearly established. Our entry into the UK with the first fuel ethanol plant being set up for British Sugar is another milestone", said Pramod Chaudhari, chairman, Praj. The next stop for Praj will be the US where Praj is actively pursuing leads and is confident of concluding some contracts in the coming three to six months. Apart from series of new orders in domestic market, the company has also started getting repeat orders from international customers in Latin America and South East Asia. As on date, Praj has orders on hand worth over Rs 450 crore. The Board has approved investment of funds received through preferential allotment to expand R&D center and other resources. The new R&D center will further take on biotechnology oriented projects in areas beyond alcohol/ethanol technology. The proposal to acquire facilities in the US/Europe, to enhance the global delivery model, has also received a nod from the Board. This facility will augment Praj's existing resources and enable the company to move into newer markets without losing focus on existing markets and current commitments. "The objective is to grow newer geographies while capitalizing on the good will in the existing market. Hence, we have devised a strategy wherein our existing clients will not be disturbed by our global ambitions," said Pramod Chaudhari. NPIL to acquire Pfizer plant NPIL to acquire Pfizer plant NPIL to acquire Pfizer plant Nicholas Piramal India Ltd (NPIL) is set to acquire Pfizer's manufacturing plant in Britain. "The Morpeth site is one of Pfizer Global Pharmaceuticals' largest high-quality, integrated facilities," a Nicholas Piramal statement said. According to an official statement to the BSE, Nicholas Piramal said that the acquisition would expand the company's global footprint, particularly in the finished API, contained finished dosage, packaging and supply chain areas. The Indian pharmaceutical company has signed a deal to acquire the Morpeth manufacturing facility on an asset purchase basis. This facility has potential outsourcing revenues exceeding $350 million. The transaction is on a liability and cash free basis. With this acquisition, Nicholas Piramal would emerge as one of the world's top 10 pharmaceuticals outsourcing companies. India to host InCoB 2006 India is hosting the fifth annual international conference of the Asia Pacific Bio-informatics Network (APBioNet), InCoB 2006. This conference provides an international forum that presents cutting-edge computational biology applications and findings on interdisciplinary research such as molecular evolution, health, agriculture, sequence and structure analysis, etc. InCoB 2006 will be held at Hotel Ashok in New Delhi on December 18-20, 2006. This event will bring together global scientists and practitioners from a wide range of disciplines, including molecular biology, medicine, computer science, mathematics and statistics. It will provide a common platform for both academia and industry to come together to enrich themselves with current developments and future trends in the field of computational biology and for developing products and services. Wockhardt in-licenses dermatology drug from LSI Wockhardt has signed an in-licensing agreement with Life Sciences Investments, a UK-based company specializing in dermatology, to market Vitix, a patented product for the treatment of vitiligo, a pigmentation disorder. "This agreement is part of Wockhardt's initiative to bring new advances in medicine to India," said Wockhardt chairman, Habil Khorakiwala. "We plan to expand our portfolio in cardiology, diabetology and dermatology by introducing new products that have proved their effectiveness in other parts of the world," he added. Vitix, a gel for topical application, will be manufactured by Wockhardt in India from active pharmaceutical ingredients (API) imported from LSI. Vitix is expected to be launched in India in the last quarter of 2006. Indian pharma industry worth $6 billion The Indian pharmaceutical industry seems set to emerge from the confines of the generics market in which it has largely positioned itself and could soon become a major player on the global scene. A report launched by KPMG International suggests that India now has the potential to become the region's hub for R&D, manufacturing and exporting. Much of the impetus behind India's fresh challenge for a greater share of the global industry is driven by last year's introduction of product patents. Commenting on the report's findings, John Morris, Global Head of KPMG's Pharmaceuticals practice, said: "The Indian pharma industry is currently worth $6 billion â€“ in a global industry worth $650 billion â€“ but is growing at ten percent, compared to the global industry rate of seven percent. The generics business remains at the heart of everything India does well and so it should, considering that India accounts for 22 percent of the global generics market. Bearing in mind that $65 billion of prescription medicines in Europe and the US are to lose their patents in 2007-08, India is ideally positioned to sweep up much of that new business. However, the opportunity now exists for India to become so much more than just a generics player." GE Healthcare's first IDC opens in Bangalore GE Heathcare has announced the opening of its first Integrated Development Center (IDC) at Manipal Hospital in Bangalore. The IDC in Bangalore is expected to conduct around 1,000 scans annually as part of the planned clinical trials and will be part of a series of global multi-country clinical studies in the US, the European Union and several other countries. Over time, GE Healthcare will establish more IDCs in key strategic locations globally. The first studies will focus on Visipaque (iodixanol), an isomolar contrast agent that was launched globally by GE Healthcare in 1996. Under the terms of the collaboration, physicians at Manipal Hospital will act as study investigators and provide clinical and imaging services and administration in the hospital. The IDC in Bangalore will play a crucial role in GE Healthcare's ongoing global clinical research program and support its vision of "Early Health" by helping to bring new diagnostic imaging agents to market and working to address serious unmet medical needs in oncology, neurology and cardiology. The collaboration between GE Healthcare and Manipal Hospital will benefit local patients in a number of ways. Particularly, the investment in imaging infrastructure will increase access to the most advanced medical diagnostic technology available. Panacea enters FMD vaccine segment Panacea Biotec will rollout a Foot and Mouth Disease (FMD) vaccine in the coming 18-24 months. It has collaborated with National Research Development Corporation (NRDC) for in-licensing of technology to produce and market the Foot and Mouth Disease (FMD) vaccine developed by Indian Veterinary Research Institute (IVRI). Elaborating on the tie-up, Rajesh Jain, joint managing director, Panacea Biotec, said, "This collaboration will significantly enhance Panacea Biotec's position in the biotechnology arena. We felt that there is an urgent need of introduction of the FMD vaccine in the country, as its eradication is essential. The product has a high potential and after the successful introduction of the vaccine in India, we will move towards supplying it to the rest of the world. " Fielding queries regarding Panacea's entry into the animal vaccine segment, Jain clarified, "There is no conscious shift per se. The FMD vaccine will give additional width to our product portfolio. Most of the companies in the vaccine arena do have a veterinary arm as an offshoot to the human vaccine segment. The FMD vaccine will be one of the products at our multi vaccine facility and we are aiming at a 25-30 percent capacity growth every year. According to the agreement, NRDC will facilitate the transfer of know-how for the process of FMD vaccine manufacturing incorporating a new adjuvant developed by the IVRI, while Panacea will manufacture and market it in the country. Without disclosing the financial details, Jain stated that part down payment has been made to NRDC, while the rest of it will be made post the technology transfer. He added, "Within the next 18-24 months, the vaccine would be ready for launch, post the technology transfer, up scaling exercise and regulatory clearances." Nandan Biomatrix opens facility at Agri-Science Park Nandan Biomatrix Limited has opened an R&D, process and formulation, and biodiesel facility at the Agri-Science Park (ASP) of International Crops Research Institute for the Semi-Arid Tropics (ICRISAT) in Hyderabad. Agri-Science Park, which brings together the expertise of ICRISAT, the state government and private sector companies, helps technology commercialization to aid farmers in the semi-arid tropics. Nandan Biomatrix's biofuel unit at the park will be able to use multiple feedstocks such as Jatropha, Pongamia etc. The facility is also expected to standardize herbal extracts, produce standardized bulk extracts and develop specialty formulations. Bollgard farmers are being charged a fair price: Monsanto India chief Bollgard farmers are being charged a fair price Bollgard farmers are being charged a fair price: Monsanto India chief Bollgard cotton provides tremendous economic benefits to farmers, as evidenced by its rapid adoption rate in India. According to the research firm IMRB, Bollgard generated Rs 2,100 crore in additional profits for the more than one million Indian farmers who planted it last year. IMRB found that for every Re 1 in technology fees spent by farmers for Bollgard, they receive Rs 5.8 in value from reduced insecticide costs and increased yields over conventional cotton. Speaking to mediapersons on the sidelines of Bangalore Bio 2006, Felipe Osorio, managing director, Mahyco Monsanto Biotech (India) Ltd (MMB) said, "While the benefits of this technology to Indian farmers are clear, it is similarly clear that Monsanto charges a fair and reasonable price in India at Rs 900, which is in fact, a lesser price on average when compared to prices in China, where agricultural practices are distinctly different." In China, farmers are primarily planting varietal cotton seeds as opposed to high-yielding hybrid cotton seeds preferred by Indian growers, and Chinese growers plant more seed per acre than their counterparts in India. The technology fee charged by Monsanto in China based on its contractual agreement for Bollgard seeds, calculated on a per-acre basis, averages between Rs 1100 and 1200 per acre, he informed. Nevertheless, MMB has informed its partners that effective from June 10, 2006, it will temporarily decrease the technology fee for its popular Bollgard cotton technology to Rs 880 per 450 gm bag. MMB is taking this action in order to comply with an interim order from the Monopolies and Restrictive Trade Practices (MRTP) Commission requiring MMB to change its technology fee of Rs. 900 so that it would be "reasonable" and similar to the price Monsanto charged in neighboring countries like China. MMB's request for a stay of the MRTP ruling is scheduled to be heard by the Supreme Court during the first week of July, with the merits of the appeal to be heard beginning the last week of August 2006. The final selling price for Bollgard cotton to farmers is set by MMB's seed company partners, and this technology fee reduction may or may not have any impact on the market at this point in the season, in light of actions by others to set Bt cotton seed prices. "This entire episode has been very unfortunate for the future growth of agriculture in India. Efforts to arbitrarily set prices take away the ability of seed companies and technology providers to meet farmer needs today and in the future, and will ultimately result in fewer choices for farmers who wish to be on the cutting edge in using leading technologies," Felipe Osario added. MMB is still hopeful that the situation will be resolved satisfactorily. "It's my strong hope," said Osorio, "that when we set the technology fee for the next growing season, it will once again be based on the value our technology creates for farmers, and that will serve as evidence of India's ongoing commitment to a free market economy." Agri ministers' meeting In a major development, a meeting of agriculture ministers of seven cotton growing states chaired by Andhra Pradesh chief minister, YS Rajasekhara Reddy, in Hyderabad on June 9, 2006 unanimously decided to jointly fight a legal battle against MMB to ensure sale of Bt cotton seeds at Rs 750 per 450-gram packet as ordered by the Monopolies and Restrictive Trade Practices Commission (MRTPC). Ministers representing Gujarat, Karnataka, West Bengal, Tamil Nadu, Madhya Pradesh, Maharashtra and also Andhra Pradesh have signed a common MoU to the effect that they would all implead as parties before the MRTP Commission and the Supreme Court in the case and invite other states as well. By another resolution, the meeting appealed to the Centre too to implead itself before the Supreme Court. It wanted the Centre to introduce legislation on seeds on the lines of the one proposed by the Andhra Pradesh government. New varieties Meanwhile, Monsanto is all set to introduce two more genetically modified crops, Bollgard 2 and new corn seed in India. The company has got approval for the latest Bollgard technology and commercializing of the seed is expected to start during this season which will enhance the quality of the seed. Both the new genetically modified varieties will undergo field trials at 14 places in the country and right now the company is in process of deciding best states where actual tests can be performed. BS Bureau   ]]> <![CDATA[http://biospectrumindia.com/images/content/2006/jul/]]> https://biospectrumindia.com/news/95/5997/http-biospectrumindia-com-images-content-2006-jul-.html https://biospectrumindia.com/news/95/5997/http-biospectrumindia-com-images-content-2006-jul-.html Sat, 15 Jul 2006 10:38:00 +0530 Suppliers Suppliers' Business continues to boom Indian life science suppliers business grows by 40 percent. With the Indian pharma and biotech companies focusing on increasing their R&D spend and expanding their manufacturing capacities, the life sciences suppliers industry is growing in line with the biotech industry. India has been one of the fastest growing regions for several leading global suppliers. Global majors like Agilent, Waters, Sartorius, Shimadzu, Millipore, and Pall are growing their bases here and are also expanding. Some are even setting up their R&D facilities in India The total business of the suppliers to the Indian life sciences industry in 2005-06 is estimated at Rs 1725 crore, up by 40 percent compared to the 2004-05 total of Rs 1,230 crore. In 2004-05 four companies for the first time crossed the Rs 100 crore mark. In 2005-06, six companies-Thermo Electron, Lab India, Waters India, Spinco Biotech, Becton Dickinson India, and Agilent Technologies have achieved this feat. In 2006-07, 10 companies are expected to reach this mark. Thermo Electrom with total sales of Rs 172.44 crore tops the life sciences suppliers business recording close to 71 percent growth. Previous year's leader Lab India ranks second with total sales of Rs 163 crore to the life sciences sector. Waters India with estimated revenues of Rs 160 crore from sales to the Indian life sciences companies and institutions is ranked third. Spinco Biotech is in the fourth position with revenues of Rs 138.80 crore. Becton Dickinson India with revenues of Rs 113.9 crore and Agilent Technologies with revenues of Rs 104 crore are ranked five and six respectively. Among the Top Five players, three-Thermo Electron, Waters, and Becton Dickinson are major global vendors, with direct operations in India. In fact eight of the top 10 suppliers are global majors. Only two Indian distributors fall in the list of Top 10. With over 800 products being supplied to the industry, it is difficult to analyze the market for each product category. Here, we attempt to present some of the key segments in the suppliers business. HPLC business The High Pressure Liquid Chromatography (HPLC) market in India is growing at 10-12 percent. Today's HPLCs suit many applications including separation, identification, purification, and quantification of various compounds. In India, Agilent Technologies, Shimadzu, Thermo Electron Corporation, and Waters are the major suppliers of HPLCs. This is a high value business. While MNC HPLC systems cost between Rs 10-18 lakh depending on the configuration and customization, HPLCs manufactured locally are available for Rs 7-8 lakh. This is clearly the reason for the MNC companies to be among the top 10 life sciences suppliers in India. Spinco Biotech, a Chennai-based company, is the major distributor of Shimadzu HPLCs. Over the years, Spinco has established an installation base of more than 4000 Shimadzu HPLC systems. It is estimated that over 1500 HPLC units have been sold. The HPLCs market is estimated at about Rs 270 crore in India.The industry expects HPLCs business to grow more than 35 percent in the next 3â€“4 years. Fermentors The fermentors business is growing at 20 percent. Alfa Laval, Sartorius, Scigenics India, Chemito Technologies, New Labs and Bioengineering are some of the key suppliers of fermentors in India. Scigenics India, a Chennai-based company, which designs and manufactures fermentors and related equipment has one of the largest installed base of fermentors in the country. Scigenics has got the recognition of Ministry of Science and Technology for its research and development unit. Among the global majors, Sartorius has a strong presence in India with its BIOSTATer, a compact autoclavable laboratory fermentor/ bioreactor system. Alfa Laval is another leading name in the fermentors bsuiness. Cell culture Alfa Laval, Cambrex, Corning Life Sciences, HiMedia Labs, HyClone, Invitrogen, and Sigma Aldrich are some of the major global players offering a range of products and services in cell culture space in India. It includes vessels, media, fermentation equipments, reactors, lines etc. Most of them have direct presence in the country. Sigmaâ€“Aldrich offers animal component-free media (for CHO, hybridoma, HEK 293 cells, stem cells) for protein or antibody expression, gene therapy and tissue engineering applications. HyClone is a global supplier of cell culture and bioprocessing systems for application in research and production. Mumbai-based HiMedia Laboratories has developed its own technology for manufacture of the cell culture media. It manufactures and supplies cell culture media, sensitivity discs and allied products. Pune-based Alfa Laval India offers a range of solutions to cell culture-processing needs. Corning Life Sciences offers a range of products in cell culture space like dishes, flasks, microplates, transwell permeable supports, and cryogenic vials. The market for cell culture media in India is about Rs 20 crore. Centrifuges There are more than 20 companies that are into manufacturing and supplying centrifuges. Jainsons (India), Zenith Glasswares and Instruments, Pawan Brothers, Chemo Fab Industries, PK Chemicals and Scientific Co. REMI Instruments, and Sterling Manufacturing Co are some of the companies involved in the production of different types of laboratory scale centrifuges. Automed Systems, Axygen Scientific, Biocon Technologies, Biotech India, Genetix Biotech India, Imperial Biomedics, JH Bio Innovations, and Medi Spec Instruments India are some of the leading supplirs of centrifuges in India. The market for centrifuges has been growing at around 35 percent. The market for small laboratory centrifuges is about Rs 100 crore with over 20 players. Distributors have a major market share. Alfa Laval, Sartorius, Thermo Electron, and Westfalia Separator are major global names with direct presence in India. Informatics The market for Laboratory Information Management Systems (LIMS), software tools that help automate the collection and management of the data generated in a laboratory, too is too is opening up. While Kolkata-based LabVantge, Ocimum Biosolutions, Persistent Systems and Chennai-based Agaram Industries are some of the Indian players offering LIMS products, large multinational companies like Agilent, BioRad, Perkin-Elmer, Thermo Electron Corporation, and Waters are also offering informatic products. In fact most of these big players are now focusing on providing end-to-end solutions for labs. The informatics market according to industry estimates is growing at about 30 percent. Hybridization ovens Hybridization ovens are fast becoming the preferred method of hybridization technique in today's laboratory. Though a few companies in India manufacture hybridization ovens, most of the requirement is met by multinationals. Neolab Instruments, Nu Tek Instruments, and Shambhavi Impex are a few local manufacturers. Other major players include Affymetrix, Amrex, Centurion, GE Healthcare, Techny, and Thermo Electron. MediSpec and Spinco Biotech are the major distributors. ]]> <![CDATA[Photonic Marksman]]> https://biospectrumindia.com/news/95/2156/photonic-marksman.html https://biospectrumindia.com/news/95/2156/photonic-marksman.html Fri, 14 Jul 2006 16:01:00 +0530 Photonic Marksman PerkinElmer provides products and services in photonics and health sciences markets that require innovation Photonic Marksman PerkinElmer provides products and services in photonics and health sciences markets that require innovation, precision and reliability. PerkinElmer India is a JV company between Labindia Instruments Pvt Ltd and Perkin Elmer Singapore Pte Ltd. Established in 2004, it operates as the exclusive distributor in India for entire range of Life and Analytical Science (LAS) products of PerkinElmer. In the second year of its operations, Perkin Elmer India has grown its biotech revenue to Rs 18 crore, recording over 40 percent growth in its biotech business. The company has recorded a significant growth in its microarray business and radioactive counters business during the year. It has about 20 array systems installed in the country till date. By the next year, Perkin Elmer India aims to do Rs 27 crore worth biotech business. By 2008, the company plans to touch the $50 million mark in this segment. During the year it has introduced several new product lines like Gel Imaging, from basic to high ended models, liquid protein array, image chemiluminance, liquid handling models. Currently with an employee strength of 170 individuals, it has 10 sales offices and service centers spread across India. To cater to the increased volumes of business, by the next year the company is planning to increase its workforce to about 200 personnel. The parent company PerkinElmer Inc., focuses on providing solutions, which integrate technology and applications. It is focused in the business areas of life and analytical sciences and optoelectronics and is a leading provider of scientific instruments, consumables, and services to the pharmaceutical, biomedical, environmental testing and general industrial markets. The company designs manufactures, markets and services products and systems within its two business units. The LAS division of PerkinElmer Inc. provides drug discovery, genetic screening and chemical analysis tools. It also provides instruments, reagents and services for scientific research and clinical applications. Its product portfolio includes assay platforms, plate readers, genetic screening/diagnostics, high through put screening, DNA and protein microarray, live cell imaging, proteomics, maldi-o-tof, radioactive counters, liquid handling systems, research reagents among others. Its product brands include Delfia research and genetic screening solutions from Wallac, MultiProbe automated liquid handling systems, Clarus family of gas chromatographs, LabWorks LIMS/enterprise software solutions, Envision and Victor multilabel plate readers, TotalChrom Chromatography Data Handling software, among others. The manufacturing facilities of PerkinElmer are in the US, Italy and Singapore. Overall PerkinElmer Inc. has reported revenues of $1.5 billion in 2005 and has 8,000 employees serving customers in more than 125 countries. ]]> <![CDATA[Bio Marketer]]> https://biospectrumindia.com/news/95/1405/bio-marketer.html https://biospectrumindia.com/news/95/1405/bio-marketer.html Fri, 14 Jul 2006 15:59:00 +0530 Bio Marketer Labmate Bio Marketer Labmate's customer base encompasses leading research establishments, major hospitals and new biopharma companies involved in recombinant vaccines and drug discovery. Labmate was founded as a partnership company in 1989 with the objective to be the comprehensive partner in India, for the manufacturers worldwide in the field of biotechnology. Later it was incorporated as a private limited company in 1992. The company has four divisions-Instruments, Biologicals, Drug Discovery and Frontier Tech. The Instruments Division offers products such as benchtop fermenters, robotic liquid handling workstation, gel documentation system and electroporation / cell fusion. The range of products from the Biologicals division includes restriction and modifying enzymes, protein tools, polymerases, antibodies for cell signaling pathways and magnetically activated cell sorters. The drug discovery division offers products in the fields of cellomics, genomics, proteomics, electro physiology, in-vivo and molecular imaging. The company represent principals like Carl Zeiss, Scigenics, Xiril, New England Biolabs, Finnzymes, Genetix, Bruker Daltonics, Biospace France, in India. Today, Labmate represents the interests of several world leaders in their respective fields. The customer base now encompasses almost all the leading research establishments in life sciences of ICAR, ICMR, CSIR labs, universities and major hospitals with research facilities, the recent market segment being the new biopharmaceutical companies involved in recombinant vaccines and drug discovery. Recently the UK-based robotics manufacturer Genetix appointed Labmate as their marketing partner for micro-arrays and microarray scanners in India. Hi-tech instruments of the company, to be available in India would deliver high throughput gene expression analysis aimed at genomics labs and research and drug discovery firms across India. Labmate now is a team of over 65 professionals and provide service all over the country with headquarters in Madras and branches in Delhi, Mumbai, Hyderabad, Bangalore, Lucknow, Chandigarh and Kolkata. ]]> <![CDATA[Consistent Growth]]> https://biospectrumindia.com/news/95/2300/consistent-growth.html https://biospectrumindia.com/news/95/2300/consistent-growth.html Fri, 14 Jul 2006 15:58:00 +0530 Consistent Growth Imperial has grown by leaps and bounds since inception in 1992 and the growth has been consistent and well defined Consistent Growth Imperial has grown by leaps and bounds since inception in 1992 and the growth has been consistent and well defined through these years. Imperial Life-Sciences (P) Ltd, formerly known as Imperial Bio-Medics (P) Ltd, markets a wide range of biological research products. This includes sophisticated genomics platforms, molecular biology reagents, kits, biochemicals, immunological reagents, clinical diagnostic kits, laboratory consumable products among others. During 2005-06, the company's revenue was Rs 26.88 crore, up from Rs 19.38 crore in the previous year, registering a healthy 38.7 percent growth. Earlier operating from Chandigarh, Imperial Life-Sciences shifted base to its new 15,000 sft facility in Gurgaon in December last. Its new set-up is equipped with latest communication equipment and storage facilities. The company has also set up a well-equipped and full-fledged "Application Support Laboratory" at this facility. The lab has latest technologies such as Fast PCR, Real Time QPCR, Automated DNA Sequencer and other laboratory equipment and plans to add micro array scanner and spotter to this facility soon. Imperial has been doing good business. The company received the "Best Distributor of the Year" award consecutively in 2004 and 2005 from Stratagene Inc., one of its key principals. Presently, it has a marketing alliance with about 45 international companies including Stratagene, Matrix, Analytic Jena, Fisher Scientific, Ameresco among many others. To streamline and efficiently reach its customers, the company has established two separate divisions- Instrumentation and Bioinformatics; Specialty Reagents and Consumables. Supply of bioinformatics software and tools is a new segment which it has added to its portfolio. Currently it represents Iobion Labs, a division of Stratagene and Premier Biosoft, Inc, USA. During the FY 2006, the company did business worth Rs 1.45 crore in this segment. The company provides complete solutions for Real Time QPCR techniques, microarray products from spotters to scanners, micro array consumables, custom assays and reagents, automated liquid handling systems, protein crystallography systems, electrophoresis equipment and supplies, complete range of PCR consumable, enzymes, biochemicals, custom probes and primer services, molecular biology kits, antibodies, cell biology products, tissue culture products, liquid handling systems, filtration and dialysis products, scientific equipment and a wide range of laboratory disposable plasticware products. At its recently set up application support laboratory in Gurgaon, Imperial provides complete technical training and application support to its customers in designing and optimization of various QPCR assays, product validations and trouble shooting for researchers working on QPCR, microarray and other techniques. In order to provide the best possible products and services to its customers in India, Imperial Life Sciences has built a complete distribution network from the ground up, with subdivisions, branch offices, and sales executives in all major cities and regions. It covers the entire market of India through an established network of its own stock, sales and service centers in cities of India such as Mumbai, Bangalore, Hyderabad, Chandigarh, Lucknow and Kolkata. The company has over 10,000 satisfied customers in research institutes, biotech, biopharma companies, universities, hospitals and diagnostic centers. Its key customers include companies in the biopharma, biotech, agriculture, veterinary sciences segment along with universities, medical colleges, drug discovery labs, clinical trial and contract research facilities and research institutes. ]]> <![CDATA[Single Fermenter Tech Pioneer]]> https://biospectrumindia.com/news/95/1795/single-fermenter-tech-pioneer.html https://biospectrumindia.com/news/95/1795/single-fermenter-tech-pioneer.html Fri, 14 Jul 2006 15:56:00 +0530 Single Fermenter Tech Pioneer Alfa Laval India was the first company to bring in single fermenter technology to India in the late Single Fermenter Tech Pioneer Alfa Laval India was the first company to bring in single fermenter technology to India in the late 1980s. Alfa Laval India has its presence in India since 1937 as a sales company for Alfa Laval Group. It manufactures and supplies a wide range of key components and systems in separation, heat transfer and flow technology to life sciences companies. In 1987, it became Alfa Laval India Ltd. Subsequently in 1993, Alfa Laval India became a holding company of Alfa Laval AB Corporates, Sweden with which it has a technical collaboration. It manufactures and supplies a wide range of key components and systems for food, chemical, biotechnology and pharmaceutical industries at its plant at Pune. Alfa Laval India started its business in life sciences with Biocon India as its first client. It has established itself as a supplier of fabricated and separation products in the biopharma applications. Alfa Laval India is supplier of plate and spiral exchangers, centrifugal separators and decanters, flow equipment and complete projects and systems. Alfa Laval India was awarded GMU (Group Manufacturing Unit) status by Alfa Laval, Sweden, to manufacture centrifugal separators and decanter centrifuges for exports to Alfa Laval Sweden, Japan, Spain and Denmark. Alfa Laval India received ISO 900:2000 certification from Lloyds Register Quality Assurance - LRQA (UK) for its manufacturing units and after sales services. Alfa Laval offers customized and comprehensive process systems/solutions such as cell culture reactors, clean in place, formulation, separation and filtration, high purity water, media and buffer prep and waste in activation to the biotech industry. Alfa Laval India is the first company to bring in single fermenter technology to India in late Eighties. It has entered into a tie-up with Katzen International Inc. US, to bring vapor phase molecular sieve technology. Its fuel ethanol program has been gaining prominence in Asia and South East Asia. It has installations in Vietnam, Thailand and Indonesia and India. For the year 2005-06, its total sales from two of its business segments, which it considers as the primary segment such as equipment, process technology and other divisions, stood at Rs 591.54 crore. Its sales from life sciences division have dropped to Rs 30 crore during the year. However, its sales from life sciences division in 2004-05 touched Rs 46 crore as it received a major order from Biocon India during the year. The company feels that the rapid increase in capacity additions witnessed in the past in biotechnology will not continue for sometime though the business in biotechnology is expected to grow at a lower rate. ]]> <![CDATA[Versatile Player]]> https://biospectrumindia.com/news/95/2432/versatile-player.html https://biospectrumindia.com/news/95/2432/versatile-player.html Fri, 14 Jul 2006 15:55:00 +0530 Versatile Player Wipro BioMed is India Versatile Player Wipro BioMed is India's only biomedical, health and life science service provider offering integrated products, services and solutions. Wipro BioMed is the healthcare and life sciences focused business division of Wipro Ltd. It is India's only industry player which addresses both healthcare and life sciences customers offering integrated products, services and solutions focused on the domestic market. Built on over 17 years of industry experience, Wipro BioMed has more than 2000 customers in diagnostics, life sciences and medical systems. Its customer profile spans hospitals, life sciences labs, CROs and diagnostics chains. Wipro BioMed has five businesses â€“ life science group, diagnostics system group and medical systems group, professional services group and specialty products group. The company has developed expertise in consulting, deploying, servicing and backup of diagnostics, life sciences and medical devices. It has strong partnerships with leading technology providers and a number of alliances. Some of its best of breed, alliances include Vital Scientific, Instrumentation Laboratory, Partec, Promega, Fujinon, Adaltis, and Alfawasermann TTP LabTech, Ciphergen, Alpha Innotech, Fluidign, Hamilton)among others. A significant strategy Wipro BioMed adopted this year was to launch its own brand LabLife, with a range of diagnostic equipments and reagents. Products launched thus far include reagents and equipments, an automated haematology analyzer, ELISA washer and reader, equal performance reagents and open platform reagents in biochemistry and haematology. The philosophy of Wipro LabLife is to provide clinical labs and hospitals with cost efficient solutions that lower the cost of patient care. LabLife has Wipro BioMed's quality assurance, LifeQ, value addition through quality assurance with a laboratory that has facilities for testing each and every batch of reagent before it reaches the customer. In life sciences, Wipro BioMed has adopted solutions based approach to life sciences business with focus on proteomics and genomics products. The categories include fluorescence imaging, micro array scanner for proteomics and genomics, flow cytometer, protein crystallography, high content screening, detection systems and high through screening systems. In medical business, it partners with Fujinon to market cutting edge technology range of flexible endoscopes like Double Balloon technology. So far, there are 8 installations of Double Balloon. It currently has four fully working Fujinon service centers with ability to resolve technical issues on all Fuji scopes. In services, Wipro BioMed offers complete lab management services under the brand name LifeServe that includes product support services, customer service outsourcing, facilities management, manage labs and project consultancy. The services business accounted for 6.02 percent of the company's revenues for the year 2004-05 that went upto 6.58 percent in 2005-06. Wipro BioMed has over 2000 customers and more than 150 distributors across the country. These distributors are managed through a unique initiative called DistinctLife. An innovative remote support operation, D-RoC for distributor contact, support and delivery based out of Bangalore supports the DistinctLife program. It has more than 400 active service contracts and a highly skills service and support team. Wipro BioMed is also one of the few companies in this industry to have a central IT enabled call center that works as the nerve center for customer interactions. ]]> <![CDATA[Technical Supporter]]> https://biospectrumindia.com/news/95/6666/technical-supporter.html https://biospectrumindia.com/news/95/6666/technical-supporter.html Fri, 14 Jul 2006 15:54:00 +0530 Technical Supporter Genetix provides marketing and technical support to some of the world leaders in life science products for Technical Supporter Genetix provides marketing and technical support to some of the world leaders in life science products for research. Genetix Biotech Asia is headquartered in New Delhi for over 15 years and provides some of the global brands for molecular cell biology kits, reagents, tissue and cell culture serum/media, plasticware, chromatography media/columns, and sophisticated instruments. It was founded in 1991 with the representation of Stratagene and was previously named Chem-Tech India. In 2002, Genetix Biotech Asia was incorporated from a proprietary firm into a private limited company. Today it has been credited with establishing brands in India for some of the leading companies such as Strategene, BioRad, Clonetech, Invitrogen, Qiagen and others. It is marketing and providing technical support for some of the world leaders in biotechnology, life sciences, molecular biology, biochemistry, protein chemistry, immunology cell and tissue culture and chromatography product companies in India. During 2005-06, the company has grossed a turnover of about Rs 40.1 crore, up from Rs 32 crore during the previous fiscal, registering over 25 percent increase in its business. During the next fiscal, the company aims to increase its revenue by about 40 percent. Presently, Genetix stocks and sells over 5000 lines of products for some of the best manufacturers such as Qiagen GmbH, Fermentas Life Sciences, Ambion Inc., Operon Biotechnologies GmbH, Amaxa GmbH, Whatman Biometra GmbH, Nalge Nunc International,, Nunc A/s, Tosoh Bioscience GmbH, Santacruz Biotechnolgies and many others. Along with the kits, reagents, media, the company provides laboratory equipment for molecular biology labs such as thermal cyclers, gel doc systems with transilluminator, hybridization ovens, sequencing and electrophoresis apparatus with power supplies, liquid handling robotic systems, etc. Now Genetix is looking beyond supplying products, it is embarking upon manufacturing molecular biology kits and reagents both for local and the export markets. The company has total workforce of 80 individuals which includes a strong marketing team of 40 sales personnel. Genetix has a highly competent technical support team of qualified specialists for serving the needs of the biotech industry. The company has a good warehousing facility for perishable reagents like biological enzymes and serums and has developed in-house software to manage its huge stocks. It has the expertise, a good network, logistics support to service the needs of the pharmaceutical and biopharma companies for their R&D, pilot scale to production needs. It has offices in Chennai, Bangalore, Hyderabad, Mumbai and Pune in India along with a well-established dealer network across the country. In addition to its Indian offices, Genetix has also established offices in Bangladesh and Sri Lanka. ]]> <![CDATA[WFI Specialist]]> https://biospectrumindia.com/news/95/2705/wfi-specialist.html https://biospectrumindia.com/news/95/2705/wfi-specialist.html Fri, 14 Jul 2006 15:53:00 +0530 WFI Specialist Pharmalab offers a range of Water for Injection WFI Specialist Pharmalab offers a range of Water for Injection (WFI) Systems, sterilization, filtration, process, and packaging solutions which meet international standards. Pharmalab India Pvt Ltd is an ISO 9001 and DNV registered firm and offers a range of Water for Injection (WFI) Systems, sterilization, filtration, process, and packaging solutions for the pharmaceutical and biotechnology industry. These solutions are result of its four decades of R&D technology upgradation, reengineering and customization and conform to the international standards. To cater to the increased quality demands of the customers and to conform with cGMP standards, it has set up five state-of-the-art manufacturing facilities, two at Mumbai, two at Ahmedabad and one at Thane to manufacture WFIs, sterilizers, storage and reactor vessels, filtration and packaging equipment. Its manufacturing facilities are focused on narrow concentration for product standard and improvement backed by the R&D department. In the field of filtration, it has achieved technological advances through its earlier joint venture with Pall Corporation. Since 1962, Pharmalab has been manufacturing quality equipment for the pharmaceutical and biotechnology industry. Filtech Pharmalab Pvt Ltd and Pharmalab Engineering India Ltd, the subsidiaries of Pharmalab merged with Pharmalab India Pvt Ltd in March 2006. Leading biotech and pharmaceutical companies have been utilizing its range of products from WFI systems, filtrations and sterilizers. Besides catering to the needs of the local market, Pharmalab has been exporting its products to countries like Bangladesh, Egypt, The Netherlands, Vietnam, Nigeria, Ukraine, Syria, the US, Thailand, Malaysia, Indonesia, Singapore, Russia and Iran. Pharmalab's WFI system comprises multicolumn distillation plant, WFI storage system, WFI distribution loop system and pure steam generator. Based on raw water analysis, it designs the pre-treatment system to provide water suitable for distillation and pure steam production in Pharmalab's water still and pure steam generator. The pre-treatment system comprises pressure filters, activated carbon filters, DM plant or reverse osmosis system (with softener), ultra-filtration system, UV sterilizer, storage and distribution loop system. Its sterilization systems such as dry heat sterilizers, bung processor-cum-steam sterilizer, super heated water spray sterilizers, steam sterilizers comply with CGMP. Starting with the pharmaceuticals, its filtration solutions are offered to a variety of other industries like chemicals, foods, beverages, breweries, distilleries, cosmetics. It has the distinction of being a good fabricator as well as knowing the technology of filtration through a variety of applications handled. Its filters are known for savings in the cost of filtration. Its total sales turnover for the year ending March 2006 stood at Rs 73 crore against the previous year's total sales of Rs 46 crore. And 90 percent of its sales were from life sciences and biotechnology divisions that total to Rs 65.7 crore. ]]> <![CDATA[Health Booster]]> https://biospectrumindia.com/news/95/1299/health-booster.html https://biospectrumindia.com/news/95/1299/health-booster.html Fri, 14 Jul 2006 15:52:00 +0530 Health Booster GE Healthcare Health Booster GE Healthcare's vision for the future is to enable a new 'early health' model of care focused on early diagnosis, pre-symptomatic disease detection and disease prevention. GE is a diversified company with each of its businesses managing their own staffing needs, including foreign assignments. GE Healthcare provides transformational medical technologies and its expertise in medical imaging and information technologies, medical diagnostics, patient monitoring systems, drug discovery, and biopharmaceutical manufacturing technologies is helping clinicians around the world re-imagine new ways to predict, diagnose, inform and treat disease. GE Healthcare's broad range of products and services enable healthcare providers to better diagnose and treat cancer, heart disease, neurological diseases, and other conditions earlier. The company's vision for the future is to enable a new "early health" model of care focused on earlier diagnosis, pre-symptomatic disease detection and disease prevention. Headquartered in the UK, GE Healthcare is a $15 billion unit of General Electric Company (NYSE: GE). Worldwide, GE Healthcare employs more than 43,000 people committed to serving healthcare professionals and their patients in more than 100 countries. GE Healthcare is broadly divided into five areas of research, bioprocess, protein sciences, discovery sciences, genomic sciences and services. The company has equipment and reagents to target these four broad categories (plus services). Its India branch office is a direct marketing and sales office for the Global GEHC life sciences group. The products range from drug screening, cellular assays, cell processing, nucleotides, enzymes, biochemicals, radiochemicals, nucleic acid synthesis, amplification and purification, DNA sequencing, microarrays, proteomics, electrophoresis, spectrophotometry, blotting, imaging and analysis and protein purification. Recently GE announced a $250 million infrastructure investment in India, with projects targeted in infrastructure, healthcare and real estate. ''Our target is to create sales and assets worth $8 billion by 2010. We will focus on infrastructure, while increasing our footprint in financial services, technology and developing business with our local partners,'' GE chairman and CEO, Jeff Immelt said. GE will be a partner in Dr Naresh Trehan's Medicity project, a world-class integrated healthcare facility in New Delhi. Beyond financial investment, GE will also provide end-to-end early disease prediction, diagnosis and monitoring tools like advanced medical diagnostics, Cathlabs and anesthesia systems, and partner in clinical research and education programs. GE Healthcare is focusing on educating and implementing an early health model, while developing and introducing new products designed to meet specific Indian needs - delivering easier, earlier and more accurate care in locations with limited access to hospitals. It is setting up India's first radiopharmacy center in Delhi. The new radiopharmacy center will offer isotopes and radiopharmaceuticals in unit doses to various nuclear medicine hospitals and healthcare centers in and around Delhi. The company has planned additional radiopharmacy centers for Mumbai, Bangalore and Hyderabad. The center will be operational by the end of the year. GE Healthcare is looking at entering the real-time label-free protein interaction analysis market by acquiring Biacore AB for SEK330 per share, an offer that values the company at SEK3.2 billion ($435.9m) or about SEK2.9 billion net of Biacore's cash reserves. ]]> <![CDATA[High-tech Plumber]]> https://biospectrumindia.com/news/95/7237/high-tech-plumber.html https://biospectrumindia.com/news/95/7237/high-tech-plumber.html Fri, 14 Jul 2006 15:51:00 +0530 High High-tech Plumber Sartorius India has positioned itself as a total solutions provider in biotech engineering and bioprocessing. The Sartorius Group is a worldleading laboratory and process technology supplier covering the segments of biotechnology and mechatronics. Headquartered in the university town of Goettingen, Germany, Sartorius was founded in 1870. The company has the distinction of pioneering several developments and innovations, especially inlaboratory weighing and separation technologies. Since 1996, Sartorius has not only expanded its operations globally spearheaded by seven group brands, but has also successfully positioned itself in three technologies of the 21st century â€“ biotechnology, mechatronics and environmental technology. Sartorius has production facilities in Europe, Asia and America as well as sales subsidiaries and local commercial agencies in more than 110 countries. Currently it employs a workforce of nearly 3,750. Sartorius supplies an extensive range of products and solutions, which form the backbone of quality processes in organizations that rely on an extremely high degree of precision and accuracy. The biotechnology division focuses on filtration and separation products, bioreactors and proteomics that find applications such as liquid and air filtration, cell culture, ultra pure water systems, fermentation and process validation among others. The mechatronics division manufactures equipment and systems, which feature weighing, measurement and automation technology for laboratory and industrial applications, as well as hydrodynamic bearings. Sartorius mechatronics applications range from heavy-duty weighbridges and tank and silo weighing equipment to high precision instruments like laboratory balances, moisture analyzers and laboratory automation equipment. Sartorius' key customers are from the pharmaceutical, chemical and food and beverage industries and from numerous research and educational institutes. Sartorius has developed an unparalleled culture of innovation and engineering, which has resulted in the development of several path-breaking technologies in mechatronics. Some of the company's stellar innovations include the development of the Sartorius nanogram balance, which holds the world record for the most precise weighing and creation of the world's first ultra-microbalance with a weighing capacity featuring a resolution of 21 million digits. Sartorius India offers customers across the country the company's global range of quality engineering products and services. The company operates one of only four system manufacturing facilities of the Sartorius Group, in Bangalore. Sartorius India has built itself a strong base of customers as it has effectively translated and imbibed customer requirements and evolved innovative solutions with the gamut of regulatory requirements. Sartorius India group a Rs.100 crore entity, has also developed a strong export market for its biotech engineering systems and has served clients in USA, Germany, Australia, China, Cuba, Hong Kong, Indonesia, Israel, Malaysia, Korea, New Zealand, Taiwan, Thailand and UAE. ]]> <![CDATA[Aqua Purifier]]> https://biospectrumindia.com/news/95/2160/aqua-purifier.html https://biospectrumindia.com/news/95/2160/aqua-purifier.html Fri, 14 Jul 2006 15:50:00 +0530 Aqua Purifier Millipore India has made its mark as a leader in water purification systems Aqua Purifier Millipore India has made its mark as a leader in water purification systems. Millipore is a leading bioprocess and bioscience products and services company offering solutions that optimize development and manufacturing of biologics. Millipore also provides high performance products and application insights that improve laboratory productivity. In India Millipore also offers effective filtration solutions for various industrial filtration requirements through its MID Division. For over 50 years, Millipore has been the market leader in the purification and filtration business. Millipore has its world headquarters at Billerica, Massachusetts. Millipore recently received antitrust clearance from the Federal Trade Commission to buy Serologicals Corp. (SERO) for $31.55 per share in cash. The agency granted early termination of the waiting period required under the Hart-Scott-Rodino Antitrust Improvements Act. The strategic combination of Millipore and Serologicals will significantly strengthen Millipore's Bioscience Division by giving it leading positions in a broad range of high growth segments such as drug discovery products and services, antibodies, cell biology reagents, and stem cell research. Millipore expects to increase sales of Serologicals' products in international markets such as Europe, Asia and Japan, where Millipore has a significant presence. Millipore India was founded in 1987 and is a joint venture with Millipore Corporation. With revenues of Rs 690 million in 2004-2005 and 225 qualified scientists, engineers, pharmacists and other staff, the company has consolidated its position as a leading bioscience service provider. To provide world-class services and support to its customers, the company has invested in cutting edge infrastructure at its corporate office and facilities at Bangalore. These include state-of-the-art manufacturing facility, high technology consulting lab offering validation and process development services, R&D center, software development center and training center. Millipore India has three business divisions. The Bioprocess division offers solutions that optimize development and manufacturing of biologics. The Bioscience division provides high performance products and application insights that improve laboratory productivity. The Millipore Industrial Division (MID) addresses the filtration requirements of the micro-electronics industry such as manufacturers of ICs, optical discs, optical fibres and color picture tubes, as also magnetic tapes, automobile components, inks, latex products, emulsions, lacquers and coatings. MID products are also used in oil-hydraulic applications and by the aeronautical and automotive industries. The division markets filters, purifiers and fluid delivery systems for Mykrolis Corporation (earlier the Millipore industrial division) and Entegris. The Bioprocess division provides fast, efficient solutions and processes for higher purity and yields. Innovations include solutions for aseptic processing, viral clearance, normal/TFF filtration, chromatography systems, media, microbial testing and many more. A world-class Access lab delivers high-tech, end-to-end consulting expertise in validation and process development. Millipore provides total pure water solutions from tap water to ultrapure water. Plus validation and service support. The company partners researchers in protein research, genomics and drug discovery and small volume filtration applications. Its solutions in PCR and sequencing cleanup, plasmid prep and blotting are very popular. ]]> <![CDATA[Precision Mechanist]]> https://biospectrumindia.com/news/95/1711/precision-mechanist.html https://biospectrumindia.com/news/95/1711/precision-mechanist.html Fri, 14 Jul 2006 15:49:00 +0530 Precision Mechanist India Precision Mechanist India's growing economy and precise R&D activities will help Shimadzu Analytical (India) increase its growth rate. Shimadzu Analytical (India) Pvt Ltd, a wholly owned subsidiary of Shimadzu Corporation, Japan has been offering technologies in the field of analytical and scientific instrumentation, diagnostic medical imaging, and process control instrumentation, environmental monitoring to different industries including life sciences and biotechnology. It boasts of well-developed R&D in the areas of its specialization. Shimadzu has established its name in the R&D and QA labs in the country. In April 2006 it has opened its customer support center equipped with the state-of-the-art instruments in Mumbai. The center will focus on customer training and aid in analytical method development for its customers. Shimadzu Analytical (India) is investing about Rs 4 crore (100 million Yen) in India. With an initial staff strength of 20 personnel, it plans to increase it to 40 within a year. In addition to overseeing the activities of the customer support center, it will also provide marketing support to its distributors. With an annual turnover of Rs 150 crore, Shimadzu has been marketing its products through distributors namely Toshvin Analytical, Amkette Analytics, Swan Environmental, and Spinco Biotech for more than 35 years (since 1970). About 60 percent of its total sales (i.e. Rs 90 crore) were from the life sciences industry. Shimadzu has 30 percent market share in the analytical and scientific instrumentation market in India that is estimated to be about Rs 500 crore. Shimadzu is setting up a software development center to meet the Corporation's software needs. The center will also act as a support hub to the South Asia region. Shimadzu is looking at achieving a target of Rs 300-400 crore in the next five years. Shimadzu's Biotech division is focused on providing integrated solutions for life science and drug development to accelerate the progress of biotechnology in research and development. Shimadzu Biotech represents a new way of thinking in the health and life science sectors by combining a core competence in instrument design and manufacture together with strategic partnerships to advance the development of knowledge in biotechnology. Product offerings include mass spectrometry integrated with enabling technology for high throughput analysis (MALDI, LC/MS, automated systems for analyzing gels with mass spectrometry) and specific solutions for DNA analysis (ranging from UV spectroscopy to chip-based electrophoresis) among a range of other offerings. One of its researchers, Dr Koichi Tanaka, shared 2002 Nobel Prize for chemistry for the development of Matrix Assisted Laser De sorption Ionization, a popular technique to ionize proteins, a useful tool in biotechnology research. ]]> <![CDATA[Tech Innovator]]> https://biospectrumindia.com/news/95/6680/tech-innovator.html https://biospectrumindia.com/news/95/6680/tech-innovator.html Fri, 14 Jul 2006 15:47:00 +0530 Tech Innovator Agilent LSCA India offers new and futuristic technology solutions as well as next Tech Innovator Agilent LSCA India offers new and futuristic technology solutions as well as next-generation products for its customers. Agilent Technologies is a global technology leader, delivering innovative tech nologies in communications, electronics and life sciences. One of its core businesses, the Life Sciences and Chemical Analysis (LSCA) group is a world-leading provider of instruments, supplies, software and services to life science and chemical analysis markets. Agilent India focuses on the entire life sciences value chain with backward and forward integration with cutting edge technologies. During 2005-06, Agilent LSCA India has shown an overall growth of 37 percent, with its total revenue increasing from Rs 102 crore in FY 2005 to Rs 140 crore in FY 2006. According to industry estimates, the life sciences revenue stream accounts for nearly 75 percent of the total LSCA turnover-about Rs 104 crore. Hence its life sciences business has recorded about 45 percent growth over the last year. Globally the revenue of Agilent LSCA is $1.5 billion in 2005. During the year, Agilent continued to be a dominant player in the liquid chromatography and mass spectroscopy market and holds a significant market share in this segment. Till date the company has installed nearly 2000 LS/MS systems in the country. Its HPLC systems continue to be a key growth driver due to its compliance, credibility and reliability in the industry. The laboratory informatics systems offered by the company is also finding an increasing market. In this year, Agilent has been able to procure orders from the top CROs, clinical research, and contract research and manufacturing organizations. In the future, this customer segment is going to be a major focus for the company. Agilent launched a couple of new sophisticated products during the year, 1200 series LC and 6000 series LCMS which have received a phenomenal response from the leading biopharma players in the country. The group has been offering new and futuristic technology solutions and its ability to integrate core technologies in molecular biology, nanotechnology and semiconductors with information sciences software and genetic engineering, biotechnology has led to significant innovations. For instance, the company had launched the first "printed" DNA microarray using inkjet technology to deposit DNA on small glass slides, first "Lab-on-a-chip" system, a postage stamp-sized sample analysis system that can be used to study DNA, proteins or whole cells; and first liquid chromatography chip (HPLC-Chip), a miniaturized device that facilitate the rapid analysis of proteins. In addition, Agilent LSCA offers a broad range of instruments, laboratory supplies/consumables including microarray scanners, software and bioinformatics, reagents, microfluidic-based sample analysis systems, LC systems, columns and components, capillary electrophoresis systems, purification systems, protein identification systems, mass-spectrometry systems including ICP-MS, GC/MS and LC/MS; automated sample-preparation systems, laboratory-computing and data networking systems. For pharmaceutical companies, Agilent LSCA also offers multi-vendor compliance services. Even as Agilent LSCA India strives to provide more innovative solutions for its customers, it will continue to introduce new technologies for biotechnology research as well as next-generation products that address automating the entire scientific workflow to improve productivity and efficiency. Agilent India is LSCA's fourth largest country of business in Asia and this year the India office has also received the best country award in the Asia Pacific region. ]]> <![CDATA[Biomedical Model]]> https://biospectrumindia.com/news/95/1517/biomedical-model.html https://biospectrumindia.com/news/95/1517/biomedical-model.html Fri, 14 Jul 2006 15:46:00 +0530 Biomedical Model BD India provides a host of products and services for the life sciences market Biomedical Model BD India provides a host of products and services for the life sciences market, accelerating biomedical discovery. Becton Dickinson India, a wholly owned subsidiary of the US-based Becton Dickinson and Company (BD), provides laboratory equipment, medical supplies, devices, diagnostics and solutions for biotechnology research to the Indian industry. During 2005-06, the total turnover of BD India was Rs 218.5 crore, while the biotech business turnover for the same fiscal was Rs 113.9 crore. The company is a prominent player in the immunology and cell analysis sector. Its Immunocytometry systems provide flow cytometry solutions for research and clinical use with applications for immune function, vaccine research, infectious disease, and oncology. During the year, the company's flow cytometer and cell analysis reagents segment has grown considerably. Till date, in India, BD has supplied about 250 flow cytometers and has captured nearly 90 percent of the market. Increased stem cell research, stem cell sorting and AIDS (CD4) monitoring have been the key drivers behind the increased life sciences revenue of BD in the country. Generous research allocations both in the private and public sector, clinical research organizations, biopharma companies has helped in fueling the life sciences business of the company. With better acceptance of technology in the industry, BD's products are finding an increasing market. The company is also considering a long term partner of choice for AIDS monitoring and cancer management in the country. This year, once again, nearly 100 percent of AIDS monitoring was done by the National AIDS Control Organization (NACO) on BD systems. In fact, The Clinton Foundation, spearheading a global drive against AIDS, has tied up with BD for AIDS monitoring in India, Cambodia, South Africa, Malaysia among other countries. The AIDS monitoring in India has been one of the success stories of this alliance. The worldover, BD's operations consist of three segments: BD Biosciences, BD Medical and BD Diagnostics. The biosciences segment provides integrated systems, products and services for a variety of applications in life sciences. The major products are flow cytometry systems for cell analysis, monoclonal antibodies for biomedical research, molecular biology reagents for the study of genes, cell growth and screening products and labware products, while the major products in the diagnostics segment are clinical and industrial microbiology products, sample collection products, specimen management systems, hematology instruments and other diagnostic systems, including immunodiagnostic test kits. This segment also includes consulting services and customized and automated bar-code systems. The company's medical segment provides hypodermic products, specially designed devices for diabetes care, prefillable drug delivery systems, infusion therapy products, elastic support products and thermometers. This segment also includes disposable scrubs, specialty needles and surgical products. The company has a manufacturing facility in the country, a highly automated plant at Bawal, Haryana. This facility produces disposable needles, syringes and catheters. BD India has an efficient support staff consisting of scientific advisors, application scientists and engineers for value added services to its customers. It has offices in Bangalore, Calcutta, Mumbai, Delhi and Gurgoan. In the future, BD India will have a major focus in the stem cell, clinical diagnostics/tools market and AIDS monitoring segment. ]]> <![CDATA[Water World]]> https://biospectrumindia.com/news/95/2299/water-world.html https://biospectrumindia.com/news/95/2299/water-world.html Fri, 14 Jul 2006 15:44:00 +0530 Water World Waters India is a leader in high performance liquid chromatography and mass spectrometry products Water World Waters India is a leader in high performance liquid chromatography and mass spectrometry products. Waters Corporation's high performance liquid chromatography (HPLC), mass spectrometry (MS), and services are synonymous with quality and performance in analytical labs around the world. Waters is a publicly traded corporation (NYSE: WAT) headquartered in Milford, Massachusetts. It is a member of the Standard and Poors' 500 Index. The company has manufacturing facilities located in Milford, Massachusetts, Taunton, Massachusetts, Wexford, Ireland and Manchester, England. Waters sells direct in most of the countries its serves. Waters differentiates from the competition by providing best in class products backed up by best services in the Analytical Instrument industry in India. Waters sales and marketing personnel and the service engineers are highly trained and have great regard in the industry. Waters Corporation are the recipient of Omega Northface Scoreboard Award for excelling in customer service expectations. The study covers Technical support, field service, Sales Process, customer service and Product Quality. The "Acuity UPLC" through its "disruptive Technology" broke through the conventional performance barriers of speed,sensitivity and Resolution. Waters Aquity Systems sets new standards in terms of speed, throughputs and quality of LC and MS Analysis. Waters India started operation in 1988. In 1997, it became a subsidiary of Waters Corporation. Major areas of activities in India are: sales and marketing of LCs,MS, informatics solutions and the wide range of columns and chemistries supported bya wide network of Customer Support group. Customer support includes apart from installation and maintainace support of equipment, exhaustive efforts in the areas of application support,customer education programs and validation support. KV Venuguoplan has been president of Waters India since it became a subsidiary of Waters Corporation. Under his leadership, Waters India business has grown in high double digit growth rate for the past five years. Waters India has achieved the distinction of best performing subsidiary of Waters Corporation in 2005. Waters India is headquartered in Bangalore with field offices in Mumbai, Hyderabad, New Delhi, Chandigarh, Ahmedabad and Kolkata. Waters customers in India are the major biotech, pharmaceutical companies, major testing centres. Its products and services help the pharmaceutical companies analyze their products to develop new molecules, to determine physico-chemical properties, conduct clinical trials and meet quality requirements for release of manufactured product. Most major prescription drugs are analyzed on Waters instruments. With addition of Informatics solutions range, Waters can provide comprehensive end-to-end solution for labs, from sample preparation, to data handling to report generations for submissions. Waters Corporation is a leader in liquid chromatography and mass spectrometry products world over and Waters India is leader in this market in India. Recently Waters Corporation announced that it is the recipient of its fifth consecutive Omega Northface ScoreboardSM Award for exceeding customer expectations in service and satisfaction during the prior calendar year. The award is administered by the Omega Management Group, a leader in implementing customer satisfaction and retention programs. ]]> <![CDATA[Lab Leader]]> https://biospectrumindia.com/news/95/2440/lab-leader.html https://biospectrumindia.com/news/95/2440/lab-leader.html Fri, 14 Jul 2006 13:59:00 +0530 Lab Leader Thermo Electron Lab Leader Thermo Electron's merger with Fisher Scientific has created the largest one-stop-shop in laboratory products and services in the life, laboratory and health sciences industry. Thermo Electron Life and Laboratory Sciences (LLS) India Pvt Ltd, a wholly owned subsidiary of the US-based Thermo Electron Corporation, is a key supplier of advanced analytical technologies, scientific and laboratory equipment and laboratory consumables. It has a manufacturing unit at Navi Mumbai that produces a range of finnpipette for ELISA readers and washers, both for home and export consumption. Its clients base include most of the government-sponsored research institutions and private sector research organizations, biological institutions, hospitals, R&D wings of the pharmaceutical companies. Thermo Electron has been serving the customers from the Middle East, South Asia and Africa region. But since last year, its focus has been on South Asian countries like Nepal Bangladesh, Sri Lanka with more emphasis on the growing Indian market. Considering this, Thermo Electron opened a new customer demonstration laboratory in Mumbai in 2005, to serve local customers. The new center is equipped with state-of-the-art customer demonstration and training facilities. The new facility offers customers with hands-on experience with Thermo's laboratory and manufacturing process solutions. It has doubled its head count, which is over 100 now. The demonstration center has a house laboratory and life sciences solutions, including ion trap and triple quadrupole mass spectrometers, centrifuges, incubators and microplate instruments, along with several process instruments. On May 9, 2005, Thermo formerly announced the completion of acquisition of Kendro Laboratory products. This acquisition has further strengthened Thermo's market position in the world and has made Thermo Electron one of the largest companies in the biotechnology and scientific instruments field in India. In May 2006, Thermo Electron Corporation and Fisher Scientific International Inc. announced that both companies have unanimously approved a definitive agreement to combine the two companies to become new company named as Thermo Fisher Scientific Inc. and is expected to have 2007 revenues of more than $9 billion. Thermo and Fisher have complementary technology leadership in instrumentation, life science consumables, software and services. The total sales of Thermo Electron in India for 2005 stood at $38.32million (Rs 172.44 crore). It includes the sales from the life and lab sciences division and scientific instrumentation division. Over 80 percent of its sales revenue was from the local market. The company is now looking at a growth of 28-30 percent. Its sales in 2004 stood at $20 million (about Rs 86.4 crore) as against previous year's sales of $15.76 million (about Rs 70.92 crore). ]]> <![CDATA[A booster shot for biotech]]> https://biospectrumindia.com/news/95/2490/a-booster-shot-for-biotech.html https://biospectrumindia.com/news/95/2490/a-booster-shot-for-biotech.html Fri, 14 Jul 2006 13:58:00 +0530 A booster shot for biotech A booster shot for biotech Is India's biotechnology sector mirroring its software industry cousin? This question comes up regularly whenever a comparison is made between these two sectors. Like software, biotech too has been consistently growing at over 35 percent for the last three consecutive years. More than half of biotech industry's revenue comes from exports, similar to software. Like software, first time entrepreneurs are rewriting the rules of the game and keeping the industry flag flying high. From a small activity, biotech exports is gradually reaching the big league. Last year's exports of $750 million (approx Rs 3,357 crore) makes it a big player in the exports market. By the end of this year, biotech exports may cross the $1 billion mark. Not many industries contribute $1 billion or more to the national exports kitty in a year. When I pointed out this to India's minister of state for commerce, Mr Jairam Ramesh during the launch of the 4th BioSpectrum-ABLE Industry Survey in Bangalore on June 9, he was appreciative of the fact. But he was also apprehensive that biotech industry may ask for various concessions. The industry leaders present on the occasions did not ask for any export subsidy to help biotech exports. That is the way it should be. But there are many ways in which Indian government can help the industry to reach even greater heights. Many of the country's other export-led sectors were created as part of the nation's strategic policy thrust on "import substitution." No such compulsion exists for the biotech sector. Exports have happened because the biotech products are highly competitive in the international markets. Many of India's biotech exporters have world class manufacturing facilities and their strong business models are based on high quality exports, as it should be in an industry, which touches human lives in many ways. If more than 150 countries buy products from India's top biotech company like Serum Institute of India, what is the status within the our country. Not very encouraging. Does it mean that India's own citizens are not benefiting much from the biotech revolution underway in the country? The domestic market for BioPharma products is very small. The government has a role and responsibility to encourage the growth of the domestic market for biotechnology products. The successful Pulse Polio Immunization programme should be extended to offer cover to people against many other diseases. Hepatitis B gives an excellent opportunity to benefit millions of our needy citizens with affordable preventive steps. Vaccines are under development for various other diseases, which are more prevalent in our own country. The government should include these in an expanded immunization program, create awareness and demand for preventive vaccination and remove regulatory and procedural hurdles in their path. A strong domestic market for vaccines and therapeutics is a vital requirement. Increased volumes from the domestic market will further increase the efficiency of our production centers and improve the affordability of these key products, to the less fortunate citizens around the world. This is what the world's richest man, Bill Gates is planning to do with the billions of dollars at his disposal through the Bill and Melinda Gates Foundation, which also saw an eye-popping $37 billion endowment from his friend, Warren Buffet. The Gates foundations and global vaccine alliance have done more to reach out affordable drugs to the people in extreme need. Indian biotech companies are playing a key role in stretching the philanthropic billions a lot more than what it would have been otherwise. They need the national encouragement in this noble mission. This is what they want and not export subsidies. ]]> <![CDATA[Asia]]> https://biospectrumindia.com/news/95/2555/asia.html https://biospectrumindia.com/news/95/2555/asia.html Fri, 14 Jul 2006 13:50:00 +0530 Asia Asia's biotech poised for innovative growth The 20th annual biotechnology report of Ernst & Young, Beyond Borders, released during the BIO convention in Chicago, predicts that with strong government encouragements, the biotechnology industry in Asia Pacific is poised to embrace innovation in a big way. The author of the Asia Pacific part of the report, Mr Utkarsh Palnitkar, Leader of Health Sciences, in Ernst & Young. Extracts from the analysis on Asia-Pacific. Utkarsh Palnitkar, Director, Life Sciences, Ernst & Young Biotechnology continues to grow rapidly in the Asia-Pacific, as companies and governments across the region focus on this emerging sector. The Asian sector's topline revenues increased by an estimated 46 percent compared to 2004. However, as in other parts of the world, growth stemmed largely from the success of a few big companies. In Australia, strong performance by CSL, the sector's second largest company, boosted the country's biotech revenues by an astounding 64 percent, and allowed Australian and Asian biotech to reach a remarkable milestone - aggregating profitability. In other countries, leading starts continued to show strong growth. But for many smaller companies in the region challenges abound - the lack of experienced venture capital (VC) and increasing competition from new patent protections and foreign companies. Asian governments are making biotechnology a top priority, recognizing the industry's tremendous growth potential and strategic importance. For Asian countries, the focus on biotech stems from several underlying trends. The first of these is the economic liberalization. In the 1980 and 1990, China and India started to liberalize their massive economies, enacting policies to encourage deregulation, privatization and international trade. As they opened their borders, both countries have had to boost intellectual property (IP) protections. Inevitability, these measures increased competition for domestic industries, and countries are looking for areas where they might have a competitive advantage. India's prior patent laws had spawned a thriving generics industry, and these firms are now scrambling to find a competitive toehold under the new rules. Japan, an economy that has sometimes been accused of using regulations as "non tariff barriers" to shield its domestic economy, now is enacting regulatory reform to expose its sleepy drug industry to foreign competition. Asian governments also see biotech as a natural fit because it is a technology-based industry with tremendous growth potential. Over several decades, several East Asian economies, including Japan, Taiwan, Singapore and South Korea, experienced rapid growth by developing competitive strengths in high technology industries. But in recent years, many of these sectors have seen shrinking margins due to commoditization and intense price competition. Biotechnology is viewed as the next big thing - an industry with tremendous growth potential in the decades ahead. While the strategy is risky - developing biotech products is a long, expensive proposition with no guarantee of success - the industry has much higher profit potential and create high-education, high-wage jobs. The ingredients for a thriving biotechnology industry are no secret. Successful locations in the West have prospered from a combination of strong university research, experienced VC management, a highly educated labor force, physical infrastructure such as specialized real estate, and laws that support technology transfer. To varying degrees, Asian governments' strategic plans aim to replicate these success factors. But while biotech in the West took three decades to come of age, companies in the Asia-Pacific face the all-too-real prospect of looming foreign competition in the near term. They will need to accelerate development, creating unique solutions that reflect their own particular strengths and challenges. In an increasingly competitive environment, executives and policy makers are looking for focused strategies and competitive niches. Competitive niches Today's biotechnology industry is extraordinarily diverse, encompassing numerous technologies, platforms and industry segments and Asian countries are well placed to be competitive in several key areas. Contract research/ manufacturing: Research and manufacturing services are a growth sector that many Asian countries are targeting. Western drug development companies face tremendous pricing pressure in their home markets and need ways to reduce costs and increase returns for their investors and shareholders. The Asia Pacific region has long served as a hub for low-cost manufacturing, with countries such as Taiwan, Hong Kong and Korea producing everything from toys to semiconductors. More recently, China and India are transforming Western industries through outsourcing manufacturing and services. The same labor costs that facilitated each of those transitions are at place in the biotech sector - savings from outsourcing research or manufacturing to Asia can range from 50 to 80 percent. Biotech, however, has a key difference from most other industries. It is one of the most heavily regulated industries in the world, and companies must meet stringent requirements at every phase, from designing and conducting clinical trials to manufacturing finished products. To compete in this arena, Asian countries will have to raise their regulatory regimes to global standards. For instance, China has been actively boosting its enforcement of regulations covering good manufacturing practices (GMP), good selling practices (GSP) and good laboratory practices (GLP). Vaccines: Asian countries are creating competitive niches in the vaccine space by developing vaccines at more affordable prices. Using pioneering technologies and efficient production methods, companies such as China's Sinovac Biotech and India's Bharat Biotech have successfully developed vaccines for diseases such as Hepatitis A and B at a fraction of Western prices. Western companies are already recognizing that the region will play an increasingly important role in the global vaccine market and are making investments and forming alliances with Asian companies. Generics: Generics is a rapidly growing segment. Several blockbusters are scheduled to go off patent soon, and 2005 was pharma's biggest patent-expiration year ever with an estimated $23 billion worth of products losing protection. As some early biotech products go off patent, the prospect of generic biologics is equally tantalizing. Regulatory pathways are not well defined in the West, but as these issues are resolved in the years ahead, follow-on biologic products could be a lucrative growth segment. Some Asian countries are well positioned to take advantage of these changes. India, for instance, has long had a thriving generics industry because of the permissive IP laws, and Indian firms already are gearing up for the coming boom in generics. Leveraging growth There is good reason to think that Asia's biotechnology companies would follow the successful path of their manufacturing counterparts in moving up the value chain quickly. While outsourced manufacturing and research represent cash cows in the near future, many companies will inevitably seek to move from the fee-for-service model to the more lucrative, though more risky, innovation model. Foreign competition and patent protections are pushing Asian companies to become more innovative. It follows that they will seek to maximize their revenues from new drugs by pursuing sales in other markets. Ultimately, a booming Asia-Pacific biotechnology industry will raise living standards in the region, creating bigger markets for Western drugs. And more innovative companies in Asia will mean greater supply of life-saving medicines for patients around the world. ]]> <![CDATA[Opportunity beckons]]> https://biospectrumindia.com/news/95/2918/opportunity-beckons.html https://biospectrumindia.com/news/95/2918/opportunity-beckons.html Fri, 14 Jul 2006 13:46:00 +0530 Opportunity beckons Opportunity beckons Alok Gupta, Hon. Regional Director (West) ABLE & Head-Life Sciences,YES BANK The Indian biotechnology in dustry is at a nascent yet exciting stage of growth and today offers the prospect of becoming a key global outsourcing hub for the industry. However, a key stumbling block for growth of this knowledge intensive industry has been early stage risk capital. The sector has not been able to attract significant early stage investments due to a multitude of factors including risk perception, infrastructure, business models, human resources, sectoral understanding etc. However, over the last few years, due to increased interest levels from government, industry and investors alike, there have been some interesting developments in the industry. Early stage financiers, M&A, corporate partnering, governmental support, debt funding are all being availed of as sources of financing for the industry. Financing strategies differ from company to company based on their business models. For example, a large number of biotech companies in India are service providers and hence it is conceptually easier for them to raise financing as their revenue models are more predictable. For a classic biotech product company, there is a requirement for pre-seed and early stage finance during the "Funding Pit" life cycle phase. In India, this market is very limited in an organized form. While the government is attempting to provide systematic intervention through various innovative schemes such as SBIRI, NMITLI and agencies such as TDB, there remains a lot to be done from the private sector. A pioneering initiative in this regard has been started by the Department of Biotechnology (DBT), which launched the "Small Business Innovation Research Initiative" (SBIRI) to promote growth of biotechnology industry in India throughpublic-private-partnership mechanisms. SBIRI targets supporting relatively high-risk proof-of-concept research and development in small and medium companies led by technocrats. The Department of Biotechnology has established a committee of scientists and industry personnel (including YES BANK) to evaluate projects for their technical/financial and management suitability. Models like Small Business Innovation Research Initiative (SBIRI) can help in creating an investment pipeline for later stage investors with relatively limited risk appetite. A healthy venture capital industry is crucial for deep and sustainable growth of the biotech sector in India, as it provides the impetus to the entire financial chain and future capital sources such as follow on financings, bank lending, capital markets etc. Over the years, corporate venture capital has also been emerging as a funding alternative for early stage companies. Some of the private sector Venture Capital funding is emerging from established pharma/biotech companies and diversified business houses experimenting to expand their technology basket following the foot-steps of their more mature peers in developed economies. In order to attract investors and reach its full potential, there are certain key issues that need to be addressed including human resource development, instilling a patent culture, infrastructure development and financing models. The recent infrastructure developments in the form of biotech parks and incubators are very positive and should be progressed through public-private partnerships and government support as relevant. There is a need to develop innovative funding models such as PPP models between government and private sector and technology transfer cells at leading institutions. There also needs to be a focus on encouraging early stage investing in the sector through various fiscal incentives. Additionally, better regulatory support and deeper penetration of very innovative government schemes launched in recent past needs to be undertaken and implemented. With the right support and focus, the Indian biotech sector can emerge as a key outsourcing hub for the global life sciences and biotechnology industry. ]]> <![CDATA[VC funds for biotech gaining momentum in India]]> https://biospectrumindia.com/news/95/2354/vc-funds-for-biotech-gaining-momentum-in-india.html https://biospectrumindia.com/news/95/2354/vc-funds-for-biotech-gaining-momentum-in-india.html Fri, 14 Jul 2006 13:45:00 +0530 VC funds for biotech gaining momentum in India VC funds for biotech gaining momentum in India Nitin Deshmukh, Director, ABLE & Head â€“ Private Equity, Kotak Mahindra Bank The Indian biotech industry posted a very strong overall growth in 2005-06. Top line grew by 37.42 percent to record $1.45 b (Rs 6,521 crore) in revenues. BioPharma and BioAgri continued to be the critical drivers contributing to this growth rate. The good news was not just the growth in revenues but also growth in terms of number of companies, higher number of alliances, several product launches and stronger product pipelines. On the business model front, inorganic international growth seems to be the new trend and the Indian biotech sector is pro-actively repackaging itself from low-end research and manufacturing base to a value-added partner in the global marketplace. Biotech companies in India are seen to be increasingly focusing on high-end technologies, drug discovery and scalable products. Smaller biopharmaceutical companies which initially emulated the services model are moving towards innovative research and drug discovery realizing that it is imperative to move towards a product driven model to attract VC funding and scale up growth. A similar transformation is happening with India's champion bioinformatics companies who are fast incorporating wet labs for a sustainable growth. Clinical research companies were the new kids on the biotech landscape last year and were seen to be mushrooming in clusters across the country. The business models of many of theses were far from market realism though and needed strong support of business acumen and knowledgeable partnerships. While the seed companies dominated the tonnage growth of Bt cotton, a small breed of agbio companies were seen quietly making an impact globally through global partnerships in the transgenic space. On the venture capital front, the funding activity showed significant momentum during 2005-06 with the VCs getting more excited with the changed but more sustainable business models. Venture and corporate funding support to young biotech companies increased across various segments of biotechnology like bioinformatics (Ocimum and Molecular Connections), vaccines (Bharat Biotech), drug discovery (VLife Science Technologies, Advinus and Perlecan Pharma), clinical research (Manipal Acunova, SIRO, Metropolis), biopharmaceuticals (Zenotech), Agbio (Metahelix), preventive healthcare (Avesthagen) and diagnostics ( ReaMetrix). On the whole the sector attracted over $125 m funding, a 150 percent growth over the previous year. On the overall, India's biotech engine is revving louder, fuelled by increased venture capital funding and government support for sustainable business models and successful commercialization of biotech products. ]]> <![CDATA[Bioinformatics a niche sector]]> https://biospectrumindia.com/news/95/1374/bioinformatics-a-niche-sector.html https://biospectrumindia.com/news/95/1374/bioinformatics-a-niche-sector.html Fri, 14 Jul 2006 13:43:00 +0530 Bioinformatics a niche sector The challenge for Indian bioinformatics companies is to create proprietary products that will generate Bioinformatics a niche sector The challenge for Indian bioinformatics companies is to create proprietary products that will generate high-margin revenues. Biotech researchers need computational horsepower as well as superior algorithms to do prediction and hypothesize information. Biotech's sub-industry, bioinformatics which caters to this, could exceed $19 billion in revenues in 2006 globally. Roughly 10 percent of the biotech industry spending is for informatics hardware, systems, software and services. Considering the global biotech industry growth at roughly 25 percent, a substantial amount would be spent on bioinformatics by all biotech companies. Hence, bioinformatics would be a niche sector in the biotech industry. Outsourcing of bioinformatics has benefited Indian bioinformatics companies. Most of the work has happened in core sectors of bioinformatics services such as data analysis, gene annotation, database creation and algorithm and software development. Though there has been considerable success of the biotech markets globally, India still has a small opportunity in the bioinformatics space. There is a huge potential for this to grow. With revenues of around $20 million during the year ending 2005, the Indian companies are marching ahead for a larger share in the marketplace. The expectation for the year 2006 would be around $50 to 60 million overall According to other published reports, there are about 45 companies in the bionformatics space, based mostly in Bangalore, Chennai and Hyderabad with a few in Delhi and Pune. Multinationals also have shown their presence in India recently, and most of them are established players in the biotech sector and some in bioinformatics too. It would be difficult for new entrants in this space in India as the sector requires managing trained resources effectively and not seeking benefits in costs and pricing. However, the challenge for Indian bioinformatics companies is to create proprietary products that will generate high-margin revenues and focus less on low-margin service work attracting cost conscious foreign companies.   ]]> <![CDATA[Poor funding crippling R&D]]> https://biospectrumindia.com/news/95/2836/poor-funding-crippling-rd.html https://biospectrumindia.com/news/95/2836/poor-funding-crippling-rd.html Fri, 14 Jul 2006 13:37:00 +0530 Poor funding crippling R Poor funding crippling R&D Getting into the development of new generation vaccines has to be in a mission mode. Varaprasad Reddy MD, Shantha Biotechnics Ltd It took about 10 years for India to emerge as a vaccineâ€“manufacturing hub for modern recombinant vaccines. Of course, earlier to this there have been Indian manufacturers who were well established in manufacturing traditional vaccines like DTP group of vaccines. Given the complexity in identifying and developing a vaccine candidate, ten years is not a very long time when compared to the history of global leaders in recombinant vaccine development and manufacture. This can be amply illustrated from the history of development of two of the vaccines, which are currently attracting a lot of attention. First example is that of Human Papilloma Virus (HPV) vaccine for prevention of cervical cancer in women. Early basic research in several institutions worldwide, over a span of 10 years (1982-1992) had established that self assembled virus like particles (VLPs) of recombinant HPV L1 protein are the most appropriate candidates for a HPV vaccine. Subsequently the pre-clinical to clinical translation process for HPV vaccines by two leading companies, which began around 1993, took about 9 years to reach fruition. Same is perhaps the case with the development of the other vaccine, namely Rotavirus vaccine, for which again proof of concept information was available by as early as 1993 and further product and manufacturing process development followed by clinical testing have lead to the vaccine commercialization. It goes beyond saying that most of the crucial information for making both these vaccines was already patented or was being patented simultaneously. Vaccine development The history of development of vaccine for malaria or tuberculosis is long drawn, proven to be very tough and elusive. For a successful malaria vaccine, it is felt that inclusion of several antigens is required. The malaria vaccine initiative (MVI, a non-profit initiative at PATH), envisages evaluating dozens of vaccine candidates that have been identified and patented over the past decades by a variety of investigators. Further, a good adjuvant also may be needed. Therefore the MVI aims at forging in several partnerships and alliance to bring together different antigens, adjuvants and platforms together for bringing in a successful vaccine. Obviously, resolving patent issues will also be a major task. The issues with the development of an efficacious TB vaccine are also going to be similar and Aeras Global TB Vaccine Foundation is very active in this vaccine development. Therefore the complexities that have to be faced by Indian companies for the development of any of the new generation vaccines including a TB or malaria vaccine are going to be much more. First, one has to steer clear of IPRs. Second, there doesn't seem to be substantial basic research to fall back on. Third, these being major public health issues, the support from government in terms of action plans and policies is not very forthright. Finally, getting into the development of these vaccines has to be in a mission mode and is investment intensive for a small to medium size company to sustain. Other players Besides our company in India, the other companies seriously working on vaccines are Serum Institute of India at Pune, Bharat Biotech International Ltd, Biological Evans and Indian Immunologicals Ltd at Hyderabad. All these companies are engaged in developing new vaccines like rotavirus, rabies, and malaria. To my knowledge, no initiative has taken place for development of vaccine against TB. Research funding There is an immense gap for research funding. Our venture capitalists in the country are not matured enough to invest into R&D on acceptable terms. Government support for R&D is very meager and the quantum of money they disburse to any company for R&D purpose is not exceeding $1â€“1.5 m. You will appreciate that any R&D for a new or even generic product will be in the range of $25â€“30 m. Apart from this, one of the options would be to get involved in any of the global initiatives for new generation vaccines, if it ultimately leads to bringing in cost effective efficacious vaccine into our country. This would also need support and mediation of the government. Finally, in addition to the above-mentioned issues, lack of talented pool in some of the key areas is also a major concern. There is a dearth of quality and number of technically competent personnel available to the industry. ]]> <![CDATA[AP, Chhattisgarh, UK and France win Pavillion awards]]> https://biospectrumindia.com/news/95/2104/ap-chhattisgarh-uk-and-france-win-pavillion-awards.html https://biospectrumindia.com/news/95/2104/ap-chhattisgarh-uk-and-france-win-pavillion-awards.html Fri, 14 Jul 2006 13:28:00 +0530 AP AP, Chhattisgarh, UK and France win Pavillion awards Padma awardees Dr Madhav Gadgil and D Chinnaiah (sitting) pose with UP minister for Information Technology, Rajendra Singh Rana, Karnataka deputy chief minister, BS Yediyurappa and Karnataka's IT and Biotechnology secretary, Dr Anup Pujari (standing from left to right). On Day 2 of Bangalore Bio 2006, awards were given to participants under various categories for their design, ingenuity and feedback from delegates. Karnataka Deputy Chief Minister, BS Yediyurappa along with Rajendra Singh Rana and Chattisgarh Culture andTourism Minister,Brij Mohan Agarwal gave away awards and felicitated Padma Bhushan Madhav Gadgil and Padma Shri D Chinnaiah. Delivering his keynote address, Yediyurappa said, "Karnataka's success in IT and BT was due to the availability of highly qualified skilled workers and technical resources. Our scientists and PhDs have given a lead in the biotech sector and we must improve and progress from here on." In his special address at the Bangalore Bio 2006 Awards Nite, the UP Minister for Information Technology, Rajendra Singh Rana invited entrepreneurs from Karnataka to come and invest in his state. He also requested them to have a look at what UP has to offer. To replicate the success of Karnataka in the biotech sector, the Uttar Pradesh government has sought Karnataka's help. A team of state government officials will be visiting UP in the next few weeks to access the situation and to lend a helping hand. The poster session, a new section in Bangalore Bio 2006, received many creative and sensible posters from upcoming innovators and scientists. Sonu Bhaskar, Rucha Vinay Joshi, Sana Ansari and Satyalakshmi won the top honors. Aninda Sen, national sales manager, BioSpectrum, receiving the Best Small Pavillion award from UP minister for Information Technology, Rajendra Singh Rana. The States of India Pavillion awards went to the Government of Andhra Pradesh and the Government of Chattisgarh. The Research Institute awards were given away to ICAR, CSIR and the Department of Atomic Energy (DAE) while BioSpectrum, Varda Biotech and YES Bank bagged awards in the Small Pavillion category. The Medium Pavillion awards were presented to Pall Life Sciences, Strand Life Sciences and Metahelix Life Sciences while Biozeen, Alfa Laval and Sartorius clinched the Pavillion awards. The International Pavillion awards went to France and the UK. On the occasion, a special award was presented to Avesthagen, the event sponsor. Biotech fraternity speaks on soft aspect of drug development Biotech fraternity speaks on soft aspect of drug development Biotech fraternity speaks on soft aspect of drug development Dr BV Ravi Kumar, MD, XCyton Diagnostics An interdisciplinary session ontranslational research explored the way forward for drug discovery and elaborated on the major theme of soft aspect of drug development. Chairing the session, Dr BV Ravi Kumar, managing director, XCyton Diagnostics, reflected that the major challenge in the realm for drug designing is the "ability to resurrect dying products". Dr Gustaaf Van Reet, Board member and scientific advisor â€“ Janssen Pharmaceutica NV, Belgium and Viziphar Biosciences, observed that despite the dramatic reduction in the mortality rate over the past few decades and the coexistence of a plethora of needs and an equal number of opportunities, successful endeavors are still a rarity owing to the current knowledge gaps, technical gaps, reliability, liability, cost and affordability issues. He also suggested prognosis and prevention and individually targeted therapies as the emerging trends and strategies for the future. Stating the mammoth scope of the biomedicine space, Dr DK Srivastava, professor, Department of Chemistry, Biochemistry and Molecular Biology, North Dakota State University, USA, said that there were many opportunities for young researchers in the space of identification of enzymes as potential drug targets. He also added that currently there are 14,000 proteins and 75 enzymes identifies as potential drug targets. Dr John Watson, director, Pharmaâ€“Biotech, Promega Corporation highlighted India's potential contribution in the drug discovery space. He opined that chemical genomics, movement from genetics to drug discovery R&D, hunting for transitional opportunities and partnering with western companies as the next best step for the emerging Indian biotech fraternity. Multi skills a must for biotech entry Multi skills a must for biotech entry Multi skills a must for biotech entry Dr Anil Paul Kariath, president, training and consulting, Biozeen Nobby Nazareth, CEO, Leader Prospects India Pvt Ltd If young aspirants plan to make it big in the biotech industry, then they have to build soft skills along with technical capabilities and express themselves as a team player in recruitment interviews. Participating in a conference on "HRD: Shaping India's talent pool through specialization," prominent industry leaders and HR experts felt that it was difficult to find the right candidates if they are not able to tap their hidden potential. It remains a challenge to identify the right candidates. Technical quality and people skills are the key criteria for hiring and training was the next biggest challenge. Nobby Nazareth, CEO, Leader Prospects India Pvt Ltd said, "Most of the time, the candidates are not able to manage simple interviews, which is an opportunity lost for the student and the company as well. To bridge this gap, the industry and academia should work in close collaboration, build and focus beyond syllabi." Gautham Nadig, director, Metahelix Lifesciences, said that science education needs to be looked afresh as good infrastructure alone will not guarantee great scientists. It is critical to focus on a course content and faculty. "It is difficult to get PhDs and specialized skilled persons. However, what motivates these scientists to join small firms is that their ability to solve difficult scientific problems or due to ownership of enterprise, networking, money and responsibility," he said. Dr Anil Paul Kariath, president, training and consulting, Biozeen, called for a closer interaction between industry and academia to assess the right type of manpower. "Only then can we solve the problem of quality manpower with quantity manpower. The incorrect assessment of the situation has led to academia drifting from need, students not able to choose career path and hampering growth in the long run," he opined. Dr Jagadish Mittur, director, Monsanto Research Center, chaired the conference. Redefining life through stem cells Redefining life through stem cells Redefining life through stem cells Technology and biology are converging fast. The result will transform everything from engineering to art and redefine life. This enveloping theme for the session on "Frontier technology: Sowing the seeds for tomorrow" explored several opportunities around stem cells. Dr Vishwanath R Lingappa, chief technology officer, Prosetta Corporation, addressed the reason for elusiveness of bioinformatics and also highlighted the limitation of high resolution structured biology. A quick mention of Prosetta's ambitious plans for India covered the inception of the animal facility center in Mysore and extension of conformer specific monoclonal antibodies. S Abhayakumar, chairman, Lifecell, India, reflected on what and why is whipping up so much hope in the vast arena of stem cells. He also observed that the percentage research on stem cells is 85 whereas the application stands negligible (of the order of 0-1 percent) and India being host to maximum number of diseases is amongst the few countries to realize the potential of this concept. He also urged public-private partnership in the scope of research for stem cells. Abhayakumar added that he is confident that in five years "we will have cure for one or two near fatal diseases." Dr Alok Srivastava, professor, Christian Medical College, also noted on the hope and reality around stem cells. Dr Franck Molina, scientist with the Centre for Pharmacology and Health Biotechnology, France, analysed biodata integration problems and emphasized that systems biology should challenge ways of selection and development of new therapeutics and diagnostics. The other speakers at the session were Dr Anupama Gaur, application support manager, Labindia Instruments, Umesh Pawa, national manager, Applied Biosystems, who spoke on Microseq microbila Identification system and Mass Spectrometry and iTRAQ reagent respectively. EU's offerings for Indian researchers EU EU's offerings for Indian researchers Dr Andrew Sors, Minister Counsellor, Head of Science and Technology, European Commission Delegation to India, Bhutan and Nepal As the international partner in this year's Bangalore Bio 2006, the European Union (EU) announced exciting new opportunities for the research community in India, in particular with the 7th EU Research Framework Program, 2007â€“2013. This cooperation will build upon and further extend Indian participation in the current 6th EU Research Framework Program (2002 â€“ 2006). Here, more than 50 collaborative research projects include almost 75 participants in India. A few examples of institutions which are included are the Indian Institute of Science (Bangalore), the Indian Institutes of Technology in Mumbai, New Delhi, and Roorkee, the All India Institute of Medical Sciences (New Delhi) and many others. FP7 will be the largest international research and development program in the world. It is likely to have a budget in the region of 55 billion Euros (about $70 billion) during the period 2007â€“2013. It includes a wide range of activities, including collaborative research, investigator-driven research and research fellowships. Addressing a press conference, Dr Andrew Sors, Minister Counsellor, Head of Science and Technology, European Commission Delegation to India, Bhutan and Nepal, underlined the great mutual advantages both for India and the EU. "India and the EU share the proud tradition of scientific excellence as well as a strong commitment to the crucial growth of science and technology for economic growth as well as for society needs. The EU is pleased to be closely and actively associated with Bangalore Bio 2006, which is seen as a major opportunity to strengthen links and partnerships across academia and enterprise in these fields of science and technology," he added. The European Union greatly welcomes participation by Indian researchers and research institutions in FP7, in collaboration with scientists and institutions in Europe. The EU may fund successful applications based on independent peer review of proposals for joint research projects or for fellowships, he said. Science Trek draws huge crowds Science Trek draws huge crowds Science Trek draws huge crowds The centre of attraction at this year's Bangalore Bio 2006 was Science Trek, a state-of-the-art, world class laboratory on wheels dedicated to biotech, pharmacology and other science students in India. The lab on wheels is an initiative by Millipore India, Eppendorf India and Micro Devices Metrohm. It is for the first time ever that three majors have come together and invested in an initiative for students. The mission of Science Trek is to showcase and demonstrate the latest lab equipment for applications ranging from PCR, membrane filtration, ion analysis and tissue culture to sample preparation for HPLC, LCMS among others. The mobile lab will visit educational/research institutions all over the country providing a opportunity for students to see the latest lab equipment in use, get practical insights, ask questions and widen their scientific horizons. Additionally, the mobile lab will bridge the gap between the privileged, urban centers of learning in metros and the relatively unequipped labs in semi-urban and rural colleges. "Students in rural schools and colleges are at a major disadvantage, very often even basic lab equipment is not accessible to them. Science Trek will do its bit by making biotech lab related education more accessible," said Sudhir Kant, president, Millipore India. "Everyone should and will get a chance to see, touch, feel the latest in lab equipment. Our people will be at hand to explain and answer questions, clarify concepts. It is for this that all three companies have invested nearly Rs 25 lakhs in the van and the equipment," he added. Among the many Millipore products on display in the lab is Direct Q 3 - the water purification system specially designed for educational institutions. The other products from Millipore include sample preparation kits and devices, sterile and non sterile filtration units, centrifugals, general filtration accessories, ion analysis instruments from Metrohm and Cell manipulation and DNA amplification devices from Eppendorf India. The lab was inaugurated by Dr Goverdhan Mehta, former director of IISc, Bangalore. Subhash Bagaria, chairman, Millipore India and teams from Eppendorf and Metrohm were present. To begin with, Science Trek will cover educational institutions in the four states of South India. With success, the concept will be extended to other states as well. Namratha Jagtap ]]> <![CDATA[India must occupy prominent slot in global biotech arena: Dr Mashelkar]]> https://biospectrumindia.com/news/95/6813/india-must-occupy-prominent-slot-in-global-biotech-arena-dr-mashelkar.html https://biospectrumindia.com/news/95/6813/india-must-occupy-prominent-slot-in-global-biotech-arena-dr-mashelkar.html Fri, 14 Jul 2006 13:25:00 +0530 India must occupy prominent slot in global biotech arena India must occupy prominent slot in global biotech arena: Dr Mashelkar Dr RA Mashelkar makes a point during his "Vision Talk" at the CEO Conclave. If India has to get some respect ability in the global biotech region, it has to occupy one of the top five slots of the big club. With this kind of 37 percent growth year-on-year basis, we hope that India can achieve it without any problem," said Dr RA Mashelkar, director general, CSIR. Delivering the keynote "Vision Talk" at the CEO Conclave of Bangalore Bio 2006 on June 7, 2006, he urged scientists to convert the present bio-hype into bio-hope for the benefit of common man so that they can reap the benefits. "Biotech is not an end. It is a means to an end. It is to be used for the welfare of the common man and for wealth creation. A lot has been said about biotech. It is not a hype. We have to act fast to convert this hype into bio-hope," he said. Dr Mashelkar said that with three great personalities occupying the highest offices in the country, the President (a scientist), Prime Minister (an economist) and Union Minister of Science and Technology, Kabil Sibal, "it is the right time to act fast, otherwise, it will be too late." He also called on the Indian diaspora to help the Indian biotech sector move up to the next level. "The returning Indians have already added to the Indian resource pool. There are around two percent of Indian diaspora working in the Silicon Valley and earns equivalent to India's GDP. We are more interested in their knowledge base rather than the investment they could bring." "We need to create some movement for transforming bio-hype into bio-hope and bio-activism into bio-rationalism through bio-enterprise, bio-wealth, bio-financing, bio-regulation and bio-education," he said. In the Asia-Pacific region, Australia occupies the first slot followed by India and China. He also called upon venture capitalists to take some risks, instead of treading on the beaten path. "They have to be adventure capitalists. If the venture capitalists can take some more risks, these entrepreneurs can definitely make a difference and take Indian biotechnology to a new level. The windows of opportunity is open and it will be open for only a short time." After IT and BT, Bangalore will be the place for Nano Biotechnology. (NBT) However, Dr Mashelkar coined a new acronym saying NBT should refer to Next Best Technology or New Biotechnology. "India's strength lies in IT, not information technology but Indian Talent. Bangalore has lot of abundance and we should cash on it." ]]> <![CDATA[BioSpectrum launches industry reports]]> https://biospectrumindia.com/news/95/1918/biospectrum-launches-industry-reports.html https://biospectrumindia.com/news/95/1918/biospectrum-launches-industry-reports.html Fri, 14 Jul 2006 13:21:00 +0530 BioSpectrum launches industry reports BioSpectrum launches industry reports Karnataka chief minister, HD Kumaraswamy and Union minister for science and technology, Kapil Sibal, pose after the former released Bangalore Bio 2006, a special supplement brought out by BioSpectrum for the event. Karnataka chief minister, HD Kumaraswamy released BioSpectrum's Bangalore Bio 2006 supple- ment at the inaugural function of the event. The Bangalore Bio Cluster report points out that Bangalore is India's largest biotech cluster in the country with total annual sales revenues of Rs 1,400 crore. There are 175 companies in Bangalore's ecosystem, comprising biopharma, bioagri, bioinformatics, bioindustrial, biosuppliers, bioservices, and nutraceutical and herbal products companies. Bangalore is undoubtedly the most heterogeneous life scienc-es cluster in the country. It is one of the biggest life sciences clusters in the country and companies here are working in diverse areas of biotechnology like pharma, agriculture, informatics, research, and industrial applications. Bangalore's life sciences cluster has close to 175 companies. The companies are spread across all areas like clinical trials, R&D services, agri biotech, pharma biotech, Bio-IT, bioindustrial, tissue culture labs, and suppliers. In his speech, Karnataka's IT and Biotechnology secretary, Dr Anup Pujari said there was a lot of demand for clinical data generated in India. Stating that there were inadequacies in the regulatory system in India, he stressed on the need to beef up the patent infrastructure in the country. Kiran Mazumdar-Shaw, chairperson, Vision Group on Biotechnology and CMD of Biocon said, "India is changing fast in life science with the increase in availability of skilled and quality workforce. The number of returning scientists has been adding to skill base, thereby improving the standards of biomanufacturing. The clinical data research is receiving more recognition. India's drug development path is improving by rapid strides." British High Commissioner to India, Sir Michael Arthur, said Britain was the third biggest inward investor in India and India was eighth in its league table of inward investors to the UK, the biotech market value of which was over $8 billion. Most of the investors were from the hi-tech sectors like IT, biotech and pharmaceuticals, he added. Union minister of state for commerce, Jairam Ramesh, poses with Chhatisgarh Minister of forest, revenue and tourism, Brij Mohan Agarwal and chairperson of the the Karnataka Vision Group on Biotechnology and Biocon CMD, Kiran Mazumdar-Shaw, after releasing the annual issue of BioSpectrum that unveiled the 4th BioSpectrum-ABLE Biotech Industry Survey. The others chief guests at the inaugural session included Dr Villoo Morawala-Patell, CEO, Avesthagen, EF Ch. Niehe, Ambassador, Royal Netherlands Embassy, Dominique Girard, Ambassador of France to India, Embassy of France and Inga Eriksson Fogh, Ambassador of Sweden to India, The Swedish Embassy. On the occasion of Agri Biotech Day, Union minister of state for commerce, Jairam Ramesh released the annual issue of BioSpectrum that unveiled 4th BioSpectrum-ABLE Biotech Industry Survey conducted in April-May 2006. The survey shows that the industry has attained the critical momentum and is bullish. For the third year in a row, the industry has clocked growth in excess of 35 percent. In 2005-06, the industry grew by 37.42 percent to record $1.45 billion (Rs 6,521 crore) in revenue. The industry recorded 36.5 percent growth to cross the $1 billion in 2004-05. The BioPharma sector alone crossed the $1 billion (Rs 4,475 crore) mark, propelled by exports at Rs 2495.24 crore. "The BioAgri sector has recorded the highest growth, buoyed by the overwhelming response to Mahyco-Monsanto's Bollgard Bt cotton seeds. With 81 percent growth rate, the industry has shown that the 2004-05 performance was not just a flash in the pan. In fact, the popularity of Bt cotton has helped the BioAgri sector to nearly double its size to Rs 598 crore from Rs 330 crore and brought four seed companies into the BioSpectrum Top 20 rank for the first time," informed Dr KK Narayanan, president, ABLE and managing director, Metahelix Lifesciences. This year there are some surprises in the Top 20 Rankings. Pune-based Serum Institute of India, led by Dr Cyrus Poonawalla, has overtaken Biocon Ltd, the leader for the last three years, to be the No.1 biotech company in the country. Serum which sells vaccines in nearly 150 countries notched up Rs 703 crore in sales, ahead of Biocon Ltd's Rs 688 crore by Rs 15 crore. "The Top 20 list has begun to reflect the churnings and growth in the industry with all the major segments, BioPharma, BioAgri, BioIndustrial companies finding good representation at the head table of the biotech industry," said Narayanan Suresh, Editor, BioSpectrum. Namratha Jagtap ]]> <![CDATA[Industrial Enzymes]]> https://biospectrumindia.com/news/95/2915/industrial-enzymes.html https://biospectrumindia.com/news/95/2915/industrial-enzymes.html Fri, 14 Jul 2006 12:44:00 +0530 Industrial Enzymes Industrial Enzymes Industrial enzymes business has been growing in India. It was estimated to have touched Rs 375 crore with growth rate of 17 percent for the year 2005-06. Novozymes and Biocon contribute over 50 percent of the total enzymes revenue. Biocon is leading the Indian enzymes sector with Rs 85 crore (2005-06) followed by Novozymes. The other leading companies in this sector include Advanced Enzymes Technologies, Rossari Biotech, Maps India, Zytex India, Lumis Biotech and Textan Chemicals. There are about 15 companies involved in enzymes business with few into manufacturing. The rest are into the marketing business. Although the sector has been on growth trajectory, with no regulatory issues it is still to get the attention of the entrepreneurs. The sector saw no new companies during the year. It is because of high initial cost involved in setting up the facility and also lack of skilled people with technical know how. Only handful of companies like Biocon, Advanced Enzymes, Lumis Biotech, Maps India, Textan Chemicals, Rossari Biotech have established manufacturing facilities in India. The rest are involved in the formulation and trading activities. Indian companies are manufacturing microbial enzymes but still look at importing glandular enzymes. The companies have been importing enzymes from USA, Canada and China. The companies are now looking for newer areas like food processing, agriculture, animal nutrition, dairy, aquaculture and marine besides the conventional areas such as pharmaceuticals, textiles, breweries, chemicals, and tannery etc. Despite the sector witnessing a growth of 17 percent, Biocon's sales from enzymes have registered a decline of 5.3 percent during the year due to capacity constraints. The increased capacity consequent to the setting up of the new facility at Biocon Park is expected to contribute to the growth of enzymes in the coming years. Biocon develops and markets a mix of specialty and industrial enzymes for a broad range of industries. Biocon, the first enzyme company globally to receive the ISO 9001 accreditation, and India's largest producer, supplies enzymes to over 50 countries across a wide range of industry segments including healthcare, beverage, brewing, baking, fruit juice, starch & alcohol, sugar, animal health, paper & pulp, leather and detergent. Novozymes, a multinational involved in marketing of enzymes through its distributors in India, has successfully introduced the enzymatic degumming of rice bran oil. The leading rice bran oil refining companies in India have been using the enzymatic degumming process that minimizes losses of oil, produces consistent degumming results, reduces water consumption, and is more environmentally sound. Novozymes's baking enzymes Fungamyl, Pentopan, Lipopan, Gluzyme and Novamyl used to improve western-style bread have received good response from the customers. Similarly Lumis Biotech, a flagship company of Rs 160 crore Kgenix group has launched its indigenously developed peroxide killer used for removing residual peroxide from the bleach. Advanced Enzyme Technologies (formerly Advanced Biochemicals), another leading enzyme manufacturer, has consolidated its position during the year by increasing its sales revenue registering a growth rate of 41 percent. It is expected to increase its growth rate during the year since two of its new manufacturing facilities, one at Indore in Madhya Pradesh and other at Thane in Maharashtra, would be operational during the current financial year. Advanced has invested Rs 45 crore in these two facilities besides setting up an R&D facility. For Advanced Enzyme, last year was a year of development. It focused on product and process developments. It successfully complied for the SKAL International Audit for Organic Certification. With this, it joined the SKAL International Program for Organic Certification for its agriculture product AgroSEB, an organic bio enzyme. Rossari Biotech, an ISO 9001: 2000 company and manufacturer of enzymes for textile processing, has started new concept of enzymatic bio-scouring. To meet the growing demand, it imports enzymes from the US and supplies the formulations to the Indian companies. It has increased its number of customers too during 2005-06. During 2005, Lumis Biotech received approval from GEAC to import Denimax 399S, Denimax 16000 L, Denimax Acid XCL and Aquazyme Ultra 1200 L from Novozymes, Denmark with couple of conditions for value addition and export purpose. Considering the potential and opportunity in enzymes, few companies are expanding their manufacturing facilities so that they can also export their range of products. The government of India has also been considerate to the sector, as it has been funding many projects related to industrial enzymes. This will help the industry to growth and compete with the global players by launching new products in near future.   ]]> <![CDATA[Bio Pharma crosses $1 billion in sales]]> https://biospectrumindia.com/news/95/1853/bio-pharma-crosses-1-billion-in-sales.html https://biospectrumindia.com/news/95/1853/bio-pharma-crosses-1-billion-in-sales.html Fri, 14 Jul 2006 12:21:00 +0530 Bio Pharma crosses Bio Pharma crosses $1 billion in sales The BioPharma sector comprising mainly of vaccines, therapeutic drugs, animal biologicals, statins and diagnostics registered record sales of Rs 4,708 crore in 2005-06, recording 31.88 percent growth over that in the previous fiscal. And on its own, this sector alone has surpassed the $1 billion mark in 2005-06. This sector, like elsewhere in the world, is the single largest contributor to the biotech industry's size. It accounted for over 72 percent to the total Indian biotech industry's revenues of Rs 6,521 crore during 2005-06. Interestingly, the Indian biopharma sector is export driven. Exports accounted for 53 percent of the total income. Clearly, Indian biopharma companies are thinking global and global companies in India are thinking local. The mantra of Indian companies has been affordability at international quality. A quick glance at the Top 20 companies in the BioPharma business (excluding the diagnostics sector) shows that only six are multinationals, while the rest 14 are home grown companies. The diagnostics sector however has a strong MNC representation. Despite stiff competition in the international markets, the exports of biopharma products have increased from 41 percent to 53 percent. This is mainly on account of exports of vaccines and statins. The leading vaccines manufacturer, Serum Institute of India, which was India's top biotech company by revenues in 2005-06, saw 80 percent of its sales coming from exports. Similarly Biocon, the second largest company in the biopharma business, despite the pricing pressure in the global statins market, clocked Rs 603 crore in revenues. With an eye on capturing the global market, Indian companies are strengthening their manufacturing capacities and R&D focus. Take for example the two leading Indian companies in the BioPharma sector, Serum Institute of India and Biocon Group. These two companies have been granted the Special Economic Zone (SEZ) status and have been making huge investments upwards of Rs 1,000 crore on developing the infrastructure for the same at Pune and Bangalore respectively. Similarly other biotech companies like Biological E and Jubilant Organosys have submitted proposals to Board of Approval of Ministry of Commerce for setting up biotech sector SEZ at Ranga Reddy in Andhra Pradesh and at Mysore in Karnataka respectively. The Maharashtra Industrial Development Corporation too is keen on setting up such a zone at Aurangabad in Maharashtra in an area of 107 hectares to support the industry. India is now emerging as a major player in the vaccines business. The income from sale of vaccines (human health) accounted for over 38 percent share of the total BioPharma sector of Rs 4,708 crore. The vaccines business in 2005-06 is estimated at Rs 1,800 crore. Diagnostics was the next big sector with over 19 percent market share. While therapeutics and animal biologicals respectively accounted for 13.6 percent and 11.5 percent share of the BioPharma sector, the rest which includes statins and others drugs generated Rs 822 crore in revenues. Vaccines Vaccines Vaccines It was a good year for the vaccines sector in 2005-06. The business of the companies in this sector registered over 38 percent growth to notch Rs 1,800 crore in revenues. Of the Top 10 companies in BioPharma business (excluding diagnostics), five of them Serum Institute of India, Panacea Biotec, Aventis Pharma, GlaxoSmithKline, and Shantha Biotechnics are primarily into vaccines business. Both Indian as well as multinational companies are playing a key role in meeting the requirements of the huge Indian population. In India about 17 companies are involved in the marketing of over 50 different brands for 15 different vaccines. Rabies vaccine has highest sales in India from company's direct sales followed by HIB vaccine. While the vaccines business in India accounts for about 35 percent of the market, exports accounted for 65 percent of the business. Clearly, there is a stiff competition on the price front and companies are launching newer vaccines into the market to increase their revenue pie. Further, there has been an increased effort in 2005-06 on awareness campaign to expand the domestic vaccines business. Companies like GlaxoSmithKline have launched awareness program with a nationwide initiative to educate children and family members. Similarly others too have joined the fray to promote the sales. During the year, several new products were introduced in the local market. Serum Institute and Shantha Biotech have launched quadravelent vaccines, which received the best BioSpectrum Product of Year Award 2005. Wockhardt launched Hep A vaccine in India. GlaxoSmithKline announced the launch of its vaccine, Boostrix, comprising Acellular Pertussis reduced, Diphtheria Toxoid reduced and Tetanus Toxoid (dTpa) in India. Another important development has been expansion of the manufacturing facilities. GlaxoSmithKline has been setting up its production facility at Nasik, which is expected to start its operations in the second half of 2006. Biological E too is expanding its vaccine manufacturing facility at Hyderabad by investing Rs 90 crore. Further, large animal vaccines like Venkateshwara Hatcheries and Indian Immunologicals are also all set to launch their own new vaccines for human beings. Established Indian vaccine players such as Bharat Biotech International, Serum Institute of India, Indian Immunologicals, Shantha Biotechnics, Panacea Biotec, Cadila Pharmaceuticals and Biological E are working in close collaboration with both Indian and international research organizations and agencies in developing vaccines for anthrax, HPV, HIV, typhoid, Japanese encephalitis, malaria, cholera, rotavirus, HIB meningitis and other diseases. In India these are being developed in close cooperation with premier research institutes like the National Institute of Cholera & Enteric Diseases, Kolkata, National Institute of Immunology, Jawaharlal Nehru University and All India Institute of Medical Sciences, all in New Delhi, Central Drug Research Institute, Lucknow, Institute of Microbial Technology, Chandigarh, Indian Institute of Science, Bangalore, Center for DNA Fingerprinting & Diagnostics, Hyderabad, National AIDS Research Institute, and National Institute of Virology, both in Pune. Bharat Biotech International Ltd, for example, has partnered with US-based Novavax to develop avian influenza vaccine for India and other developing countries from South East Asia. This is a significant step in the public-private partnership development in public interest. These are a few examples to illustrate that Indian companies now are now looking at newer markets and newer areas. Diagnostics Diagnostics Diagnostics Diagnostics is a second major contributor to the total biopharma revenues. It accounted for about 19 percent to the total biopharma sector. The sales of diagnostics kits have been on the rise in the recent years in India with increase in per capita income, changing life style and urbanization. The revenue of diagnostics kits has gone up from Rs 601 crore in 2004-05 to Rs 905.33 crore in 2005-06. The market is witnessing both rapid growth and increased competition. With only two companies in 1976, now the diagnostic sector has about 25 manufacturers besides over 30 players including the multinationals who are doing diagnostic business in the country. Transasia Biomedicals, Roche Diagnostics and Tulip Group of Companies dominate the Indian diagnostic sector with each contributing over Rs 100 crore. Further, companies like Eisai Pharmaceuticals India, Nicholas Piramal India, Bharat Serums & Vaccines, VH Bhagat & Co, Claris Lifesciences Ltd, Arun & Co, Ruchi Corporation, Qualigens Fine Chemicals, a division of GlaxoSmithKline Pharmaceuticals, Abbott Healthcare, and Ortho Clinical Diagnostics, a division of Johnson & Johnson have been importing diagnostics kits for marketing in India along with a few other companies. In addition to these, the Indian market has been flooded with imported low cost Korean and Chinese kits. Multinationals like Abott Healthcare, Bayer Diagnostics, and Randox Labs have also been doing well in this space. However, big Indian pharmaceutical companies are shifting their focus to their core strengths from this low margin business. Ranbaxy had divested its part of diagnostic businesses during the year to ICICI Venture Funds Private Ltd. Ranbaxy Fine Chemicals Limited (RFCL), till recently a 100 percent subsidiary of Indian pharma major, is now owned by ICICI Venture Capital Fund and has four special business units. Its business unit Diagnova operates in in vitro diagnostics. Another major trend has been more and more BioSuppliers distributing diagnostic products. For example, BioRad has a strong clinical diagnostics focus and has announced several new products. Wipro Biomed has a diagnostics system group and a significant strategy that it adopted this year was to launch its own brand LabLife, with a range of diagnostic equipment and reagents. Some of the products it launched include reagents, automated haematology analyzer, ELISA washer and reader, etc. Take another example. Millipore has entered into a partnership with ReaMetrix Corp., which launched Accuford TriTStat assay, a critical diagnostic for managing HIV patients. The product will be marketed by Millipore India. Several new diagnostics businesses got established during the year. Companies like Anamol Laboratories, a new venture from M J Dashora, former Managing Director of Accurex Biomedicals, Excel Diagnostics, Aspen Labs, Genetics Specialties, Kan Healthcare, IMMCO Diagnostics, Dade Behring, and ReaMetrix have started their diagnostics businesses last year. Reliance Life Sciences too has a diagnostic division and has been marketing many molecular diagnostic kits. The Indian government too is keen on encouraging companies to invest in the diagnostic sector. The Department of Biotechnology (DBT) has been facilitating the transfer of many technologies for diagnostic kits to the industry developed at the CSIR labs. It has also been funding many projects on developing new diagnostic kits. During 2005-06, Span Diagnostics, one of the leading Indian diagnostic companies, launched SIGNAL-KA, an indigenous rapid test system for the early diagnosis of kala azar. This is a technology developed by AIIMS with the financial aid from DBT. The government has supported many such projects in the past and later transferred for commercial applications. Many companies are seeking technology transfers of foreign and in-house developed technologies for diagnostic manufacturing in India too.Existing manufacturers are upgrading their manufacturing facilities and are increasing their product portfolios.Clearly,the diagnostic market is growing at a healthy rate companies are continuing to see India as major diagnostics market and are keen to invest here. Therapeutics Therapeutics Therapeutics The recombinant therapeutics business too has shown consistent growth during the past few years. During 2005-06, the therapeutics business registered 28 percent growth with the overall recombinant biotech market business standing at Rs 640 crore. Human insulin has been the single largest contributor to this figure. About 40 companies both Indian and multinationals are involved in one of the many activities such as R&D, importing, manufacturing and marketing of recombinant biotech products. At present 14 therapeutic drugs are available in India under about 50 brands. In 2005-06, the human insulin business was estimated at Rs 330 crore. Novo Nordisk, a Bangalore based multinational company, continued to be the leader in the human insulin business with total estimated revenues of Rs 175 crore. The other major players in this segment include Eli Lilly, Aventis Pharma, Wockhardt, and Biocon. The Erythropoietin (EPO) market for the year 2005-06 was estimated at about Rs 120 crore. Johnson & Johnson is the market leader in the EPO and is followed by Wockhardt, Emcure and LG Life Sciences etc. The streptokinase market was estimated at Rs 70 crore growing at a rate of 25 percent. Shantha Biotechnics and Bharat Biotech are the two home grown companies in this space. Roche Scientific and Full Ford are the leading names in the interferon market estimated at Rs 35 crore. It is growing at rate of 30 percent. Zydus Cadila, Glenmark Labs, Nicholas Piramal, Shantha Biotechnics, and LG Life Sciences are the other major players in this segment. The market for Human Growth Hormone (HGH) and Follicle Stimulating Hormone (FSH) was estimated at Rs 20 crore and Rs 30 crore respectively. FSH market is growing at rate of 20 percent. The market for G CSF for the year 2005-06 was estimated at Rs 35 crore and is growing at a rate of 25-30 percent. Emcure, Dr Reddy's Labs and Intas Pharma are the major players in this space. Unlike the vaccines market, the therapeutics business is primarily dominated by global names. However, home grown players like Bharat Biotech, Biocon, Dr Reddy's Labs, Intas Pharma, Shantha Biotechnics, and Wockhardt have developed biotech drugs indigenously and launched their own products in areas such as streptokinase, human insulin, G CSF, erythropoietin, HGH and interferon alpha 2b. Indian companies are now investing more on R&D of these products in addition to the support these are getting from the government agencies. Biocon now sees oncology and diabetes as the two major areas for growth. Biocon has filed 266 patent applications globally and has been granted 37 patents, including eight in the US. Further, very recently, Biocon announced the availability of its monoclonal antibody, BioMAb EGFR. BioMAb EGFR, developed with the technology transferred to Biocon from Cuban Institute of Monoclonal Antibody (CIMAB), is used for the treatment of head and neck cancers. Also companies such as Cadila, Emcure Biotech, Reliance Life Sciences, Serum Institute of India, Shashun Chemicals and Drugs, Virchow Biotech, and Zenotech are working on r-DNA drugs like recombinant insulin, interferon alpha 2a, 2b, and pegylated, interferon gamma 1b, G â€“CSF, G â€“CSF (pegylated), G â€“CSF (pegylated methionyl), GM-CSF, EPO, PEG- EPO, Growth Hormone, streptokinase, TNK-TPA, and monoclonal antibodies. About 16 companies both Indian and multinational have been involved in marketing of these products. A few companies like Sun Pharmaceuticals and Torrent Pharmaceuticals are into contract manufacturing of recombinant products for multinationals like Eli Lilly and Novo Nordisk respectively. During 2005-06, while on one hand MNC companies like LG Life Sciences, Novo Nordisk and Eli Lilly got the GEAC approval to import and market recombinant biotech products, on the other hand some of the Indian companies received GEAC's nod to start production of rDNA drugs and also to scale up fermentors for R&D work. Wockhardt received approval for manufacture and marketing of r-human interferon alpha (r-DNA Origin). Intas Pharmaceuticals started manufacturing of finished formulation of r-human Erythropoietin (r-h-EPO) after receiving approval from GEAC for the same. Bharat Biotech got the permission to manufacture and market r-human epidermal growth factor. Wockhardt and Dr Reddy's Labs have got approvals to scale up to 300 L fermenter for R&D work. Novo Nordisk received approval for importing and marketing of human insulin Determir. LG Chemical got approval for import and marketing of 16 IU LG Eutropin (HGH). Wockhardt has received permission to import Erythropoietin (EPREX- with HAS, EPREX-without HAS and Neorecormon) for Test Analysis. Serum Institute of India received approval for import and marketing of r-human interferon beta 1 a from Industria Farmaceutica, Serono, SPA Italy. Eli Lilly Company (India got the permission for import and marketing of Humlog (Human Insulin Lispro â€“r-DNA). LG Life Sciences India will continue to import and market LG Espogen (r-Human Erythropoietin) and r-Interferon Injection) in India as it received permission do so for period of two more years. Going forward, the industry expects this market to one which will fetch them higher returns. Animal Biotech Animal Biotech Animal Biotech According to USFDA animal biotech products include bacte- rins and bacterial extracts, antibody products, vaccines with bacterins/bacterial extracts/toxoids, diagnostic products, antitoxins and bacterin-toxoids. But in India, we find more of fundamental or basic vaccines for poultry and large animals such as FMD vaccines, Gumboro vaccine-IBD, new castle disease vaccine, mareks vaccine, rabies vaccine and canine multi component vaccine and not other biologicals including the diagnostic kits. Therapeutic and diagnostic products are almost non-existent in India. The animal biotech market in India during 2005-06 was estimated at Rs 541 crore with vaccines contributing to Rs 354 crore growing at rate of 20 percent. There are about 30 companies in animal biologicals both in public and the private sector and are mainly into business of poultry vaccine, cattle (FMD vaccine) and vaccine for companion animals. The public sector that consists of cooperatives and state owned institutes too contribute their might to this sector. These institutes supply animal biologicals mainly basic vaccines for large animals like sheep, goat and cattle at very nominal price or free to farmers. Hence industry people say it is difficult to calculate the exact size of the animal biologicals market. Venkateshwara Hatcheries is leading the poultry vaccines space followed by Indovax, Hester Pharmaceuticals, Intervet, Zydus Sarabhai and American Home Products. Venkateswara Hatcheries, in addition to supplying to the local market, has also been exporting about 18 percent of its biotech sales to countries like SAARC countries, South Asia, Middle East, Japan, Europe, and Africa. Besides key vaccines, it also supplies influenza vaccines, diagnostic kits in small quantity and other biotech products. Indovax and Hester Pharmaceuticals have facilities for manufacturing poultry vaccines. Others are importing and marketing a range of vaccines in the country. Indian Immunologicals is leading the large animal vaccines business followed by Intervet, IVRI, and Brilliant Industries. In the companion sector, the leading names include Intervet, Serum Institute, GlaxoSmithKline, Brilliant Industries and Zydus Sarabhai. Most of the vaccines for pets are imported and supplied through distributors. The market is small compared to the other segments. But it is picking up and growing at the rate of 10-12 percent. India has a handful full of manufacturing companies in this sector. There is manifold increase in the demand for vaccines after the Indian government launched a nationwide vaccination program and FMD control program to make "disease-free zones". The government institutes are not a position to fulfill this growing demand. To meet the growing requirements India needs to look at imports. India has imported 445 kg of anti serum in 2004-05 and exported 71.9 kg in 2004-05. Similarly the country imported 1200 vials of insulin in 2004-05. In 2004-05, India imported vaccines to the tune of 68,70,000 /700 (vials/unit/doses) and also exported 3,30,950 vials/unit/doses. (These figures are up to October 31, 2004). The opportunity is opening up further. The government has been making efforts to bridge the gap between supply and demand. Considering the market opportunity companies like Bharat Biotech, one of the leading names in human biologics, Brilliant Industries, mainly into pet vaccines, Venkateshwara Hatcheries and Hester Pharmaceuticals which are mainly into poultry vaccines are entering the large animal vaccines. Other areas of animal biotech products include feed enzymes and probiotics. Recent entrants in this space include Advanced Biochemicals and Lumis Biotech who are into feed enzymes. There are many formulators and leading among them is Vetcare. Wockhardt and Dabur are also vet product formulators. Future products would include hormones (GMO), DNA vaccines and transgenic products from animal sources. The government departments including the Department of Biotechnology (DBT) have taken initiatives to strengthen the productivity and animal health related areas and aspects. Initiatives were taken from DBT to generate some close-ended projects and programs in the area of animal nutrition and developing vaccines for various diseases. During 2005-06, the DBT has funded 18 projects on vaccines, diagnostics, transgenics and cloning, poultry, animal byproducts, animal nutrition, buffalo genomics etc. There is also a proposal to set up an autonomous institution for animal biotechnology. This indicates government's keenness to support the animal farming community with the latest biotechnologies. Statins Statins Statins Statins are cholesterol-lowering agents used to treat and prevent coronary diseases and are amongst the largest selling drugs worldwide. The statins market in India is presently estimated at about Rs 300 crore (it doesn't include export figures) against last year's sales of Rs 227 crore. Biocon, India's largest and USFDA qualified producer and exporter of statins, is the market leader. Besides Biocon the other names in this market include Ranbaxy, Lupin, Themis Medicare, RPG Life Sciences, Claris Lifesciences, Intas Pharma, Medley, Sun Pharma, USV, Concord Biotech, Emcure, Zydus Cadila, Torrent, Cadila Pharma, Carsyon, a division of Micro Labs, Cipla etc. But only few companies are into manufacturing of statins such as Lovastatin, Simvastatin, Atorvastatin, Pravastatin and Rosuvastatin. The Indian statin manufacturers like Biocon, Ranbaxy, Themis Medicare and Zydus Cadila have strong exports focus. In regulated market the statins are priced at over $950 per kg while in non- regulated it is priced at $450-500 per kg. On the contrary statins are priced in the range of Rs 1,650-1,700 per kg in India. In spite of the pricing pressure in Europe and rise in material costs, the Indian companies have been looking at exports for better price realizations. Matrix Laboratories, one of the leading pharma companies, has acquired a 45 percent stake in Concord Biotech that has received USFDA approval for its Lovastatin facilities and also for manufacturing Pravastatin and Simvastatin. Biocon has seen the successful in development and commercialization of Lovastatin, Simvastatin, Atorvastatin and Pravastatin. Biocon is currently exporting Simvastatin to Europe, Japan and Canada, Lovastatin to the US and Pravastatin to the European markets. Over 60 percent of its biopharmaceutical sales of Rs 603 crore comes on account of sale of statins, largely through exports. The statin sales were affected during 2005-06 despite sharp volume growth and increased market share, due to significant pricing pressure in European markets. Sales were also affected due to delayed launch of Pravastatin and Simvastatin in the US consequent to the grant of six months exclusivity to the generic players. However, the opening up of the US market in the later half of FY 2007 is likely to see a surge in sale of statins. During first half of 2005, Zydus Cadila launched a novel statin, Pitavastatin under the brand Pitava, which is the latest addition to its family of statins. Zydus Cadila has received tentative approval from the USFDA to market Pravastatin Sodium Tablets in the US market. Ranbaxy, another leading name in statin business has been marketing all four statins-Storvas (Atorvastatins), Simvotin (Simvastatin), Pravator (Pravastatin) and Rovacor (Lovastatin). In 2005, Ranbaxy received USFDA approval to manufacture and market Simvastatin Tablets in the US. Themis Medicare last year signed an agreement with Darou Pakhsh Pharma Chem, (DPPC) of Iran, a government company manufacturing pharmaceutical preparations. As per the agreement, the company will supply DPPC with the technology for producing various biotechnological products, mainly statins and DPPC will make milestone payments to the company. Artemis Biotech, a division of Themis Medicare, is a major producer of Lovastatin and some its major customers in India include Alembic Chemicals, Dr Reddy's Laboratories, RPG Life Sciences, Sun Pharma, Unichem Laboratories, and Wockhardt. ]]> <![CDATA[Biotech industry grows 37.42%]]> https://biospectrumindia.com/news/95/2420/biotech-industry-grows-37-42.html https://biospectrumindia.com/news/95/2420/biotech-industry-grows-37-42.html Fri, 14 Jul 2006 12:17:00 +0530 Biotech industry grows 37 Biotech industry grows 37.42% ]]> <![CDATA[Industry on a roll]]> https://biospectrumindia.com/news/95/1541/industry-on-a-roll.html https://biospectrumindia.com/news/95/1541/industry-on-a-roll.html Fri, 16 Jun 2006 14:40:00 +0530 Industry on a roll Industry on a roll The 4th BioSpectrum-ABLE Biotech Industry Survey clearly indicates that the industry has attained the critical momentum and is on a roll. For the third year in a row, the industry has clocked growth in excess of 35 percent. In 2004-06, the industry grew by 37.42 percent to record $1.45 billion (Rs 6,521 crore) in revenue. In the previous year, the industry recorded 36.5 percent growth to cross the $1-billion threshold for the first time ever. What is heartening is that despite pricing pressures faced by some of the industry leaders, other players, particularly the BioAgri sector with galloping sales of Bt cotton seeds and the BioServices sector have registered handsome growth to the keep the growth momentum upwards. Another remarkable development is the BioPharma segment, which accounts for over two-thirds of the industry, on its own has recorded sales in excess of $1 billion ( $1.04 billion or Rs 4,708 crore to be precise) and has emerged a strong player in the overall pharma market which clocked sales of approximately $8 billion in 2005-06. The BioAgri sector, buoyed by the overwhelming response to Mahyco-Monsanto's Bollgard Bt cotton seeds had shown the world what it could do in the previous year itself. Last year, with 81 percent growth rate, the industry has shown that the 2004-05 performance was not just a flash in the pan. In fact, the popularity of Bt cotton has helped the BioAgri sector to nearly double its size to Rs 598 crore from Rs 330 crore and brought four seed companies into the BioSpectrum Top 20 rank for the first time. Coming to the BioSpectrum Top 20 table, there are some surprises. Pune-based Serum Institute, led by Dr Cyrus Poonawalla, has edged past Biocon, the leader for the last three years, to be the No.1 biotech company in the country. The many vaccines it sells in nearly 150 countries has given Serum the booster shot to notch up Rs 703 crore sales, ahead of Biocon's Rs 688 crore by Rs 15 crore. The Top 20 list has begun to reflect the churnings and growth in the industry with all the major segments, BioPharma, BioAgri, BioIndustrial companies finding good representation at the head table of the biotech industry. The fledgling biotech industry, which started to gain size in the 21st century, is still dependent on exports to get over half its revenue. In fact, the share of exports has increased marginally last year from 48.5 percent to 51.5 percent in 2005-06, accounting for Rs 3,357.17 crore (or $756 million). In many ways, biotech is mirroring the software industry. In fact, the BioServices sector, including clinical research and clinical trials, is predominantly dependent on foreign clients who account for 95 percent of the industry revenues of Rs 720 crore. It also indicates that the introduction of the product patent regime has prompted big pharma to move a lot of clinical trials to take advantage of India's competitiveness. That the biotech industry is research intensive is well known. This has been revalidated by the increasing investment levels (Rs 1,650 crore against Rs 1,215 crore in the previous year). The industry is investing 25.3 percent of its revenues into research and building infrastructure. The southern region as a whole continues to be second accounting for 36 percent of the industry revenues, while the West is the topper for the fourth year in a row with companies from the region totaling Rs 3,234.42 crore or 49.6 percent of the national biotech share. Overall, the industry and the BioSpectrum-ABLE Survey are breaking new grounds and the survey results will be available for the first time in two volumes with the June and July issues. Happy number crunching! ]]> <![CDATA[Government committed to revitalizing Indian agricultural research system, says PM]]> https://biospectrumindia.com/news/95/2531/government-committed-to-revitalizing-indian-agricultural-research-system-says-pm.html https://biospectrumindia.com/news/95/2531/government-committed-to-revitalizing-indian-agricultural-research-system-says-pm.html Thu, 15 Jun 2006 16:51:00 +0530 Government committed to revitalizing Indian agricultural research system Government committed to revitalizing Indian agricultural research system, says PM Delivering the valedictory address at the International Conference on Agriculture for Food, Nutritional Security and Rural Growth organized by The Energy and Resources Institute (TERI), the Prime Minister, Dr. Manmohan Singh, expressed the Government's commitment to revitalize the Indian agricultural research system, so that the world's largest agricultural research system could maintain its sense of innovation, creativity and a sense of purpose. Excerpts from his speech "No group of intellectuals or workers in the post independence India has made such a phenomenal contribution to the removal of poverty and the promotion of sustainable development than our agriculture scientists. We are very fortunate that the doyen of that group of scientists, Prof. M.S. Swaminathan is here in our midst. His life and works constitute like the life and work of Prof. B.P.Pal, a source of great inspiration and I dare say that will be so for many generations to come. Dr Pal was a great scientist and researcher, a visionary institution builder, a committed nationalist and patriot, and, above all, a fine human being. Our nation at its Independence, was blessed by a generation of great intellectuals who were also institution builders and nation builders. The great institutions of research that we are today all proud of were built by men like Dr Pal. They were men and women of great courage, foresight, and vision. Nowhere in the developing world at that time were there scientists of such global stature. Dr Saha, Dr Bhabha, Dr Pal, and so many others, built institutions of excellence like the Indian Institute of Science, the Tata Institute of Fundamental Research, the National Physical Laboratories, and this great conference of the Indian Agricultural Research Institute. The challenge before us is to preserve these institutions and build upon their achievements. I have often said that the acid test for the good health of any system is its capacity to reproduce itself and therefore, our institutions must acquire a caliber to breed excellent as well as social commitments social relevance as an integral part of their growth process. We owe this to our people and our nation. We must of course ensure that the benefits of modern education and science do reach all sections of our society. Equally we owe it to our posterity that we build and preserve institutions of great excellence and world standing. India cannot be satisfied with anything but the very best. We must have the ambition to get away from this attitude of 'Chalta hai'(anything goes). We must imbibe the inspiration, we must have the courage to think big, to think out of the box that's the only way we can use human knowledge as a major source of India's prosperity, India's growth and enabling India to acquire its rightful place in the comity of nations. It is scientists like Dr Pal and Dr Swaminathan who laid the foundations of our Green Revolution. If today India is substantially self-sufficient in food, it is to a great extent because of their dedicated work in increasing yields and incomes. The application of scientific knowledge was the essence of the Green Revolution. New seeds, new fertilizers, new ways of farming and providing extension services were all examples of the application of scientific and technological knowledge. Apart from contributing to food security, the Green Revolution also increased the incomes of farmers in many parts of the country. It has contributed to agrarian change and rural development. I salute the great scientists and our farmers for their contribution to this vital aspect of our nation building process. The Green Revolution was not just about yields and incomes. It was also about empowerment. By increasing the value of knowledge in improving the lives of our farmers, it empowered them. It enhanced the country's food security. However, we have yet to ensure the nutritional security of all our people particularly our children and women. We must ensure that the benefits of food security translate into the nutritional security of the poorest of the poor - that's the challenge. It looks formidable, but I do believe that our nation has resources and the willpower to meet this challenge. What we need today is a practical, viable strategy to reach to the poorest section of our population. Resources are not that binding a constraint today because our Government stands committed to enlarge very substantially those segments of our development program, which will help to improve the nutritional status of our women and children. I have been told our extension system is in dire need of restructuring and betterment. I do not see here any new, big ideas on how we can extend the benefits of modern science and technology in an effective manner to our farmers. All over the country I find bureaucratic hurdles have put a stop to revitalizing our extension services. I hope our scientists and technologists and the Ministry of Food & Agriculture will look into how we can find new pathways to revitalize our extension services. In the way our agricultural universities and research institutions work, we are committed to revitalizing the Indian agricultural research system. There are hurdles, there are true efforts, but you have to give us the guidance and show us the way forward, how this massive, the world's largest agricultural research system can maintain its sense of innovation, sense of creativity and a sense of purpose. We have to think fresh in the way we extend credit to our farmers and I say so for more than one reason. As our agriculture becomes commercialized, there will be more reliance on commercialized inputs. Farmers will need therefore, more credit. If you are operating a system in which more and more innovations also are the by-product of the functioning of not the public sector system, but of private enterprise and that's the reality. The first generation of agricultural research was a by-product of functioning of public sector system. In our own country, as well as abroad, now for greater reason, the science and technology is also being increasingly privatized. What are the implications of transforming our agriculture in this new era of increasingly privatized science and technology. This is also an issue over which we must ponder. If we don't pay adequate attention to this aspect of sustaining our agricultural growth in this new era, public-private partnerships can be voluntary, but very often the public-private partnership is nothing more than a buzzword. We have to convert it into a viable development strategy and I seek your talent, and your guidance as to how to cope with this buzzword. I do believe that in each of these areas the application of knowledge is crucial. As I told the Indian Science Congress earlier this year, our vision of rural India is of a modern agrarian, industrial and services economy, co-existing side by side, where people can live in well-equipped villages and commute easily to work, be it on the farm, or in the non-farm economy. There is much that modern science and technology can do to realize this vision. I do believe that knowledge can contribute a great deal to this gigantic national effort. Our scientists therefore have an exceedingly important role to play in this realm. Many of you have been preoccupied with the problem of agricultural production and productivity having hit a growth plateau. Dr Swaminathan has repeatedly alerted us to the need to give a new boost to agricultural research. I do recognize the need to increase the efficiency of utilization of inputs, the need to improve farm management practices, the need to reduce post-harvest losses through better post-harvest management technologies in storage, transportation and processing. These can increase both yields and contribute to higher income for the farmer through better value addition. We do need a lot more attention to be paid to the management of our agricultural research and technology system. We must also ponder why is that Bihar which was chosen to be the original location of the Indian Institute of Agricultural Research, why it has failed to catch up with the rest of the country? Bihar, in 1950 was described as the second best governed State in the very famous Paul Appleby Report. From that point, from that benchmark where Bihar is today in terms of its absorptive capacity? This is worthy of exploration, why a state like Bihar has not been able to catch up with the rest of the world? We must also ponder - we have Indian Rice Research Institute located in Cuttack, yet Orissa remains by and large still a mono-crop economy. There is something wrong with our ways we manage our agricultural research and technology systems and I say so with all humility. I don't know the answers but I do feel that these are issues, which need in-depth analysis. I also do believe there is a need for increased application of science and modern technology to forest conservation and management, environmental protection, management of our animal husbandry resources, water conservation and utilization of herbs and plants. We need a harmonious blend of advanced science and technology, appropriate technology and local knowledge to ensure an equitable distribution of the benefits of new knowledge. These are the objectives of what I have often called the Second Green Revolution. Dr Swaminathan and the National Commission on Farmers have suggested a "programme of renewal" that would be its starting point. To the five components suggested by Dr Swaminathan, I had added two more, when I addressed the Science Congress at Ahmedabad. The Seven components identified are: soil health enhancement through concurrent attention to the physics, chemistry and microbiology of the soils; water harvesting, water conservation and sustainable and equitable use of water; access to affordable credit and to crop and life insurance reform; development and dissemination of appropriate technologies and, improved opportunities, infrastructure and regulations for marketing of produce, the application of science and biotechnology to the improvement of seeds and utilization of herbal and other plants; the application of science to animal husbandry to improve the productivity of our livestock and poultry. We must recognize that there has been a paradigm shift in our perspectives with respect to agricultural development and research. The focus of our agriculture has also shifted from staple crops to high value crops. Apart from government funded research and extension work, we now have privately funded R&D and extension services, like e-chaupal. As I said earlier, the recent privatization of science and technology, there is also an implication on the future of our agricultural growth. How do we manage this technological revolution that does not hurt our farmers but it enables us to reach the new frontiers of production that is something I do believe require some fresh thinking. Our scientists must work with Government and non-government organizations, local bodies and corporates, to take knowledge to its user. The revolution in information technology has opened up new opportunities. It has made it easier for us to take knowledge to its user. However, the market for knowledge has not yet fully developed in rural areas. It is the responsibility of Government, of non-governmental organizations, of farmers' organizations and of the suppliers of such knowledge-based services to create such a market. Your conference has also discussed new developments in bio-technology and new materials and their contribution to agricultural development. Here again, we have been fortunate to have created a strong foundation for further development. Our track record in these areas has been impressive and holds promise of more development. Perhaps a much sharper focus is required on strategic research in plant technology. If the pattern of energy consumption and utilization in Indian agriculture can be altered, made more environment friendly and less dependent on fossil fuels, it could have far-reaching consequences for our growth process, our environment and the well-being of our people. Indian agriculture certainly needs new investments. It needs new productivity enhancing measures. It needs a new wave of entrepreneurship. The agricultural credit system must respond to the felt needs of the farmers. And so should our scientists and managers. Greater public-private partnership is required, but it must not remain a mere buzzword. It can contribute to a revitalization of public institutions and programs and for this we must use all our knowledge, wisdom and experience â€“ both in the public and private sectors".   ]]> <![CDATA[BioAgri gets a new look]]> https://biospectrumindia.com/news/95/4132/bioagri-gets-a-new-look.html https://biospectrumindia.com/news/95/4132/bioagri-gets-a-new-look.html Thu, 15 Jun 2006 16:49:00 +0530 BioAgri gets a new look BioAgri gets a new look The days of huge foodgrain mountains are long gone. From foodgrain exporter in the last years of 20th century, India's mounting agriculture crisis has forced it to float global tenders to import 3 million tons of wheat. Poor productivity levels and inadequate investments in infrastructure in the last two decades were masked by the huge surpluses, caused partly by low foodgrain buying capacity and change in lifestyle patterns shifting food patterns. But these problems cannot be wished away anymore. So the nation's top policy makers gathered in the Capital under the aegis of TERI to chalk out a comprehensive plan to revitalize Indian agriculture using the latest available technology tools, including biotechnology. Here is a BioSpectrum special report on the outcome of the meeting. The three-day scientific delibera tions at the conference on "Agriculture for Food, Nutritional Security and Rural Growth", focused in a big way on the use of modern technologies to fight the odds in agriculture. Presently Indian agriculture appears to have reached a plateau and policymakers, to right from the Prime Minister to agriculture officials in various states, have been emphasizing the need for new initiatives to boost agricultural outputs. This would not only be essential for ensuring healthy economic growth in the country but also for improving the livelihoods of the poor in rural India. This formed the focal theme of the international conference, which was organized by The Energy and Resource Institute (TERI) in New Delhi on the occasion of the birth centenary of Dr BP Pal, the first Director-General of the Indian Council of Agricultural Research and a great visionary who initiated the Green Revolution during the 1960s. During the event, scientists, economists as well as policymakers pinned their hopes on technology driven knowledge to boost agricultural production. Particularly, research advances in biotechnology were seen as a major tool of ushering in the second green revolution in the country. The presence of Dr Manmohan Singh, Prime Minister of India, at the valedictory session reiterated the commitment of the government towards agriculture and rural development. Prime Minister Dr Manmohan Singh releasing a book co-authored by Prof MS Swaminathan and Dr KL Chadha, titled Environment and Agriculture. In addition to the Prime Minister, the conference attracted a host of luminaries like Dr Montek Singh Ahluwalia, Deputy Chairman, Planning Commission; Kapil Sibal, Hon'ble Minister of Science and Technology and Ocean Development; Prof. M S Swaminathan, Chairman, MSSRF; Dr Prodipto Ghosh, Secretary, Ministry of Environment & Forest; Dr Idah Sithole-Niag, PBS Coordinator Southern Africa, Biochemistry Department, University of Zimbabwe; Dr Jose Maria FJ da Silveria, University of Campinas, Brazil, Dr William Dar, Director-General ICRISAT, Dr Thomas A Lumpkin, Director-General, AVRDC, The world Vegetable Centre, Prof Ingo Potrykus, professor, Swiss Federal Institute of Technology, Dr Derek Russell, University of Melbourne, among others. Addressing the inaugural session, Dr Ahluwalia, stressed on the need for a total revamp of the agriculture sector. He said "During the 10th five year plan the growth rate in agriculture has been less than two percent, which is a grave matter of concern. The present economic environment is not supportive of agriculture and there needs to be a systematic reorientation right from the policies, institutional credit, agri marketing to the extension services so that we have an agricultural system which is more sustainable, less water dependent." For boosting the agricultural research system, Ahluwalia assured that steps towards the implementation of the two committee reports-one headed by Dr RA Mashelkar, and another by Dr MS Swaminathan will be taken in the 11th plan. These reports elaborately address the maladies in agriculture and agri research. Overcoming Salinity Prof. Swaminathan, elaborated on the concept of ever green revolution, he said, "What land hungry, but population rich countries need is the enhancement of productivity in perpetuity, without associated ecological or social harm. The green revolution should become an ever-green revolution rooted in the principles of ecology, economics and social and gender equity." Highlighting the vagaries of Indian agriculture, he said, "Though Punjab agriculture has progressed, but farmers have become poor. The production of wheat, rice and cotton in Punjab has plateaued, become input-intensive and the water table has gone down considerably. He went on to enumerate several instances of how biotechnology is helping to perpetuate the evergreen revolution. Like Prosopis juliflora, which has wide adaptation to water stress and drought conditions, is being used as source material for drought tolerant genes or rice plants with a gene from mangrove species for salinity tolerance which is currently under trials. Emphasizing on the need for partnerships, he opined, "There have been considerable talks about public-private partnership, but private-private partnership is most important in the Indian context. As in India, agriculture is the largest private venture. Leading private companies should come together with small private farmers." Kapil Sibal, Union Minister for Science & Technology and Ocean Development, in his presidential address stated, "Yields in India are significantly lower than in most other nations and the current production growth rate will have to triple if India is to feed its growing population. The solution is in the form of biotechnology and gene revolution. Biotechnology is needed to combat challenges facing India's farmers, and could spur another Green Revolution or more appropriately ever-green revolution." However, cautioning against a hasty approach, he said "We can't close our eyes to biotechnology for agriculture but at the same time we must ensure sustainable development in terms of environment and the basic interest of the farmer and consumer safety. To strike a balance, our approach should be a case-by-case basis. We have to be very careful about safety standards and ensure that the regulatory procedures are such that we don't damage our biodiversity." Genes to the rescue Elaborating on the rapid strides made by Indian agri biotech sector, he shared, "The development of several GM food crops is on the anvil to catapult India towards an evergreen revolution. India has been producing genetically modified cotton for three years now and 13 other crops - including rice, chick peas, potatoes, cauliflower and eggplants â€“ may be approved in the near-term. Biotechnology, besides creating engineered crops for stress tolerance, pest resistance and better yields, has also spilled its benefits to pharmaceuticals and energy sector. The triumph of the Indian pharmaceutical industry is exemplary. Modern biotechnology has enabled production of 99 percent of the drugs that the country needs and exports 40 percent of its production in a highly competitive global scenario. Bringing the concept of biopharmaceuticals into practice would further boost this sector". A discussion on "Green revolution to Gene revolution" kick started the technical rounds, where the contribution of traditional breeding practices in solving issues related to food security and the need for new technological inputs was analyzed. Dr CR Bhatia, former secretary, Department of Biotechnology, emphasized on the fact that all genetic improvements have been aimed at the above ground parts of the plant. The hidden half or the root has been neglected, which needs more intensive research. He said, "Genetic engineering could be used to modify plant root exudates. There is a need to emphasize on soil biotechnology, high through put DNA sequencing of soil DNA, etc. There is an urgent need for gene revolution for the areas bypassed by the green revolution like the drylands". Dr Abha Agnihotri, Fellow, TERI, shared the developments in the nutritional improvement program in Rapeseed-Mustard and genetic improvement program in soybean at the institute. Many speakers stressed the need for a public private partnership especially in the area of agricultural biotechnology. Dr Sanjay Saxena, Fellow, TERI, outlined the urgent need for this kind of partnership due to increasing stakes of private sector in agriculture /horticulture sector due to patent protection and higher returns as well as limited infrastructure, finances and trained manpower resources. Dr Thomas A Lumpkin, DG, The World Vegetable Centre elaborated on an efficient public-private partnership model in the case of vegetables and fruits-Owning to proprietary research, the private sector can provide high quality seeds, which the public sector delivery system could supply to the farmers for bringing about higher and more efficient production of fruits and vegetables. Dr Jose Maria Fj da Silveira, University of Campinas, Brazil, spoke about the agricultural public private partnership corporation-"Embrapa" and how genetic engineering has provided benefits through virus resistant papaya and common beans as well as herbicide resistant soya bean. While Dr Kiran K Sharma spoke about the private-public partnerships at ICRISAT. Taking the case study of the Agri-Science Park there, he said, "The Agri-Science park at ICRISAT is a convergence of agricultural partnerships, innovations and products for the poor. The park enhances the development, promotion and utilization of technologies from the institute and its research partners. Its components, agri-biotech park, agri-business incubator, bio-pesticides research consortium and a hybrid seed research consortia are creating synergies for the farmers and entrepreneurs through its partnerships. Utilization of current technologies, including modern biotechnology, to achieve high productivity in a sustainable manner coupled with promoting complementation of traditional technologies with modern day tools saw active participation from both the public and private sector. Dr SC Bose from Syngenta India spoke about marker assisted trait selection for accelerated breeding in crop plants. Dr Ananda Kumar, principal scientist at Plant Biotechnology Cnetre in IARI said, "Globally the area of transgenic crops in 2005 was 90 million hectares in 21 countries. Tolerance to drought and salinity, improvement of protein quality, vitamins and micronutrients, post-harvest traits, metabolic manipulation, therapeutics, edible vaccines, apomixis, and phytoremediation are some of the traits which can be worked upon in the future". Animated sessions on: Agriculture extension mechanism scenario by 2020, problem of rural migration into cities and how appropriate extension activity can reverse this trend; Case studies wherein spin-off technologies from modern agricultural research have been efficiently adopted by various end users; Balanced promotion of biotechnology through integration of scientific knowledge with proper regulatory mechanisms, impact of GMOs on the environment and human health; and Status of future crops and future needs of agricultural research were held. New Roadmap The conference served as a forum in which a road map for food and nutritional security based on sustainable agricultural practices was discussed and debated. Over 40 eminent speakers from government/various research institutions and the corporate sector shared their experiences and nearly 350 participants including postgraduate and doctoral students, and young scientists from India and overseas deliberated on important issues related to food and nutritional security. Overall the conference saw well rounded discussions in all areas touching agriculture, adoption of modern technologies for better yield, nutritional security and rural growth. TERI, which facilitates policy development both at the local and global level apart from conducting research in the energy, environment and sustainable development segment, would soon bring forward the recommendations emerging from the wide ranging discussions. Looking at the success of the event, TERI has proposed to make this an annual conference. While summing up the proceedings of the conference Dr RK Pachauri, Director General, TERI, stated, "The new paradigm for agricultural development in India has to be the sustainability of natural resources and emphasis on bringing about a revolution in rainfed agriculture. We need much greater research and experimentation, for which the upgradation of science is essential. Efficient use of groundwater, crop diversification and enhancing the seed replacement rate are necessary and overdue. Overall, the efficient use of inputs including energy, water, nutrients and pesticides should form the major objectives of innovation in agriculture. Fruit and vegetable cultivation needs to be expanded by providing the right infrastructure and incentives to farmers." He added, "Agriculture in this century has to be driven by science and knowledge. This would require enhancing various forms of infrastructure in rural areas. TERI itself has been involved in promoting a program called INSTEP Integration of New and Sustainable Technologies for Elimination of Poverty. For instance cold chains, ICT based education and knowledge dissemination and improved management of water and other natural resources would require large scale harnessing of decentralized energy resources through the use of renewable energy technologies. This would require dissemination of knowledge and empowerment of local communities, for which the NGO sector as well as private enterprises could be harnessed effectively." At the valedictory function, The Prime Minister, Dr Manmohan Singh presented the BP Pal Centenary Award to Prof MS Swaminathan to commemorate the BP Pal Centenary celebrations. He also released a book co-authored by Prof MS Swaminathan and Dr. KL Chadha titled â€“ "Environment and Agriculture" on the occasion.   ]]> <![CDATA[BT is not the culprit]]> https://biospectrumindia.com/news/95/2980/bt-is-not-the-culprit.html https://biospectrumindia.com/news/95/2980/bt-is-not-the-culprit.html Thu, 15 Jun 2006 16:48:00 +0530 BT is not the culprit BT is not the culprit Tests carried out by scientists in India and abroad on sheep, goats, buffalos, cows, rabbits, birds and fish have confirmed the safety of Bt protein There is a sensational headline grab bing lots of media attention lately: sheep are dying in India by eating Bt cotton leaves! Bt protein such as in the genetically modified (GM) cotton in India has been extensively tested in feeding trials and consumed in hundreds of millions of meals by not only livestock but also humans. There has not been a single problem ever, much less a fatality. This suggests one might want to look for a more likely culprit. In this case, as soon as one does that, the culprit seems to leap out-conventional pesticide poisoning. Or even the natural toxins that are abundant in cotton leaves. The sheep-death-by Bt Cotton-story is the latest scandalous report from the Center for Sustainable Agriculture (CSA) of Secunderabad, a "dyed-in-the-wool" group of activists who are hell bent on stopping Indian agriculture on its track to progress. They claim that hundreds of sheep died after eating leaves of Bt cotton, a crop that has been genetically modified (GM) to protect against insect attack. A close examination of the issue reveals that pesticide poisoning or the natural toxins in the cotton leaves rather than the Bt protein are the likely culprits here. The CSA report does not offer any scientific evidence to suggest the culpability of the engineered insecticidal protein in the cotton plants in the sheep mortality. While CSA calls its report preliminary, they have no compunction to blow it all out of proportions in an orchestrated effort to scare the public. Media and Internet discussion groups are abuzz with this story convicting Bt cotton of sheep death even without a trial. It is clearly a mischievous and cheap attempt to denigrate and discredit the Bt technology by anti-GM groups to fulfill their avowed goal of making India "GM-free" and rid of modern biotechnology that promises so much for our farmers and consumers. Dr. Shanthu Shantharam is the president of Biologistcs International (USA) www.biologistics.us) and an independent biotechnology consultant with expertise on the safety of biotech crops. Dr CS Prakash is a professor at Tuskegee University (USA) and president of AgBioWorld Foundation (http://www.agbioworld.org)  Indeed, it is refreshing that the state government veterinarian who conducted post-mortem on four to five sheep came to a scientifically reasonable conclusion that the sheep deaths may be due to insecticide poisoning. The autopsy reports show tell-tale signs of pesticide poisoning and the treatment prescribed by the veterinary doctor are atropine and prednisolone, a standard treatment for pesticide-poisoning from organophosphorous and carbamate insecticides. Dr Richard Roush, an internationally recognized scientist on Bt crops at the University of California (Davis), concurs that poisoning from pesticides or natural plant toxins is the likely cause of sheep death in India, and adds "These anti-GM activists, for their own ideological aims, are taking advantage of local ignorance to try to scare people off from crops that have significant health and environmental benefits. There is least effort to find the real causes." Dr Sonny Ramaswamy, an entomologist and Director of Agricultural Research Programs at Purdue University (USA), also suspects that natural plant toxins such as gossypol or other alkaloids found in cotton leaves or foliar-applied pesticides may have contributed to the sheep fatality. There are many other troubling questions here: why are these claims coming from only the anti-GM activists? Why weren't objective animal scientists engaged? Why is the "situation" limited to Andhra Pradesh? Why hasn't this happened anywhere else? Why do published animal feeding studies with Bt crops not show any harmful effects? While the actual case of sheep mortality in India must be investigated thoroughly, one can easily exonerate the Bt protein as blameless. Bt protein is present in miniscule amounts in cotton leaves whose action is so specific that it does not even damage other insects than its target, the cotton bollworm. Dozens of toxicology and biosafety studies show that Bt protein in GM crops is extremely safe. Mammals (higher animals and humans) do not have receptors for the Bt toxin unlike target lepidopetrans like bollworm. Tests carried out by scientists in India and abroad on sheep, goats, buffalos, cows, rabbits, birds and fish have confirmed the safety of Bt protein beyond doubt. Bt crops have been grown in dozens of countries across the world in the past ten years over hundreds of millions of hectares. There has never been a single credible report of damage to human or animal health or the environment from approved GM crops or the foods derived from them. Unlike conventional crops, biotech-derived crops are subjected to extremely rigorous safety-testing, and are continuously monitored after their commercialization. Bt protein in cotton leaves thus is not the culprit of sheep demise. There is nothing in the report of CSA to suggest a direct cause and effect relationship between Bt protein and the death of sheep. Yet, they have made scandalous headlines just to mislead the public. This needless sensationalization to disparage a highly effective and successful pest-control technology is nothing but political propaganda to scare Indian farmers from using it. Bt cotton technology is a proven technology that is helping farmers around the world including India to grow more crops in an environmentally-friendly manner by reducing millions of kilograms of pesticide. While the opponents of GM technology cannot produce any scientific or credible evidence that these crops are unsafe, they would not miss any chance to indict the technology with contrived fears. It is easy to dismiss such impish and irrational propaganda but unfortunately the anti-GM activists know too well that the fear-sensation is easy to sell to the gullible public and policy makers. Every toxicologist knows that "dose makes a poison", a dictum conveniently ignored by groups opposed to biotechnology. Just last year, the anti-GM zealots in India went to town crying hoarse and waving a scientific paper published by Keshav Kranthi of the Central Institute of Cotton Research in Nagpur (Current Science, June 2005) that these same varieties of Bt cotton did not produce sufficient quantities of Bt toxin to control cotton bollworm. Now, these same activists are suggesting that harvested leaves of Bt cotton (where Bt toxin should have suffered sufficient degradation) have so much toxin in them to kill a huge animal like sheep when compared to the tiny cotton bollworm. This just shows that 'die-hard' opponents of modern biotechnology will go to any length to weave whatever story to suit their political agenda. They are doing a great disservice to the farmers of India by preaching falsehoods and preventing them from using modern technologies that they so badly need and deserve. ]]> <![CDATA[Maps (India)]]> https://biospectrumindia.com/news/95/2837/maps-india.html https://biospectrumindia.com/news/95/2837/maps-india.html Thu, 15 Jun 2006 15:16:00 +0530 Maps India is a producer and exporter of industrial enzymes Maps India is a producer and exporter of industrial enzymes. With over 150 employees, a sophisticated production plant and a dedicated R&D center, it has become a key player in enzymes and microorganisms. A team of 30 scientists is involved in research and development activities at Maps India. It produces a broad range of enzymes and microorganisms at production plant spread across 57,000 smt. Maps enzymes include amylases, proteases, cellulases, xylanase, glucoamylase, pectinase, catalase and phytase, which are used in versatile industries like textile, leather, baking, alcohol, brewing, detergent, starch and animal feed. And its microorganism products are used in various applications for effluent treatment, cleaning and odor control, waste degradation, bioaugmentation and bioremediation and aquaculture. The company's production plant has solid state fermentation and submerge culture fermentation facilities along with downstream processing and formulation facilities. Maps India has invested about Rs 10 crore in Gujarat for expanding its operations and has signed a MoU with the Gujarat state government in this regard. The company is exploring opportunities in Pakistan for the export of enzymes.In 2005-06, it had sales revenue of Rs 15 crore. ]]> <![CDATA[International Panaacea]]> https://biospectrumindia.com/news/95/2606/international-panaacea.html https://biospectrumindia.com/news/95/2606/international-panaacea.html Thu, 15 Jun 2006 15:13:00 +0530 International Panaacea Ltd International Panaacea Ltd (IPL) provides new solutions in agribiotechnology through microbe based liquid biofertilizers and fungi based biopesticides. Its annual turnover during 2005-06 is Rs 21.5 crore, which has shown about 25 percent increase over its previous year's revenue of Rs 17.21 crore. Premium Azospi, Premium Phosphofix, Premium Azotoplus, Premium Rhizo are some of its important biofertilizers while Sanjeevni, Daman and Kalichakra form its biopesticide range. The company has its own R&D unit and a pilot plant where scale-up trials on strain selection and improvement, pilot scale fermentation, optimization and downstream processing are conducted. It has technical collaboration with IIT Delhi and University of Delhi, South Campus to develop enzymes for use in animal feeds both for poultry as well as ruminants. The clinical dose trials of the developed enzymes are being conducted in veterinary institutions. IPL is also setting up a referral lab for testing biofertilizers and biopesticides at its R&D center in Delhi. Within the country, International Panaacea has marketing/business alliance with Hindustan Insecticides Ltd. ]]> <![CDATA[Nicholas Piramal]]> https://biospectrumindia.com/news/95/1284/nicholas-piramal.html https://biospectrumindia.com/news/95/1284/nicholas-piramal.html Thu, 15 Jun 2006 15:10:00 +0530 Nicholas Piramal India Limited Nicholas Piramal India Limited (NPIL) is one of India's largest pharmaceutical companies with strong brand management and sales capabilities, a FDA site-approved plant for on-and-off patent APIs and Intermediates. It has R&D capabilities in basic research, process innovation, custom chemical synthesis, formulations R&D, NDDS, and also has a world-class accredited clinical research organization. It has set up an R&D center in Mumbai which can accommodate about 400 scientists. NPIL has invested 17 percent equity in Canadian biotech research company - Biosyntech, Inc. The company's revenue from the biotech division dropped from Rs 65.06 crore in 2002-03 to Rs 50.8 crore in 2003-04. It further dropped to Rs 11.5 crore in 2004-05. This is mainly because of ceasure of the agreement with F Hoffman - La Roche. Meanwhile, it has entered in licensing agreements with companies like Biogen IDEC and Genzyme Corporation. In 2005-06, its biotech sales revenue slightly increased to Rs 13.65 crore and its diagnostic sales stood at Rs 16.02 crore. ]]> <![CDATA[Dr Reddy's Labs]]> https://biospectrumindia.com/news/95/1859/dr-reddys-labs.html https://biospectrumindia.com/news/95/1859/dr-reddys-labs.html Thu, 15 Jun 2006 15:05:00 +0530 One of India One of India's leading pharma companies, Dr Reddy's ($546 million) primarily manufactures and markets API (Bulk Actives), finished dosages and biologics globally, with a focus on the US, Europe, India and Russia. In the recent past, the company stepped up its biotechnology focus. Its biologics business division focuses on developing recombinant technology. It has developed an in-house biogeneric, GRASTIM, in India. This is human Granulocyte Colony Stimulating Factor (hG-CSF), a recombinant protein used in chemotherapy-induced neutropenia and in bone marrow transplantation. The recombinant proteins technology platform is its core competency. The company's 2005-06 revenues in the critical care and biotechnology segment stood at Rs 69.1 crore, an increase of 31 percent. The increase is mainly on account of growth in its critical care division by Rs 11 crore driven by growth in revenues from exports by Rs 6.9 crore as well as growth in revenues from India by Rs 4.1 crore. The biotech portion is estimated to be close to Rs 40 crore. ]]> <![CDATA[Biological E]]> https://biospectrumindia.com/news/95/2587/biological-e.html https://biospectrumindia.com/news/95/2587/biological-e.html Thu, 15 Jun 2006 15:02:00 +0530 Though Biological E has been in operations for 53 years Though Biological E has been in operations for 53 years, it has stepped up its biotechnology focus only in recent years. It is a major player in the DPT, TT vaccines and in 2004 it commenced manufacturing of its recombinant hepatitis B vaccine, Bevac. In its first year of operation, Bevac grossed Rs 1.33 crore in sales and is estimated to have done Rs 5.25 crore of business in 2005-06. Clearly, Biological E is consolidating its vaccine business. It registered a 46.5 percent growth in 2004-05, recording Rs 28.19 crore in sales. For 2005-06, this business is estimated to be Rs 33.25 crore. A major portion of its revenues comes from the sale of DPT, TT vaccines. This business is estimated to be Rs 25.5 crore in 2005-06. Biological E is expanding its vaccines facilities. A new vaccines facility, a modern 200,000 sft building, is coming up at Shapoorji Pallonji Biotech Park at Shamirpet near Hyderabas. It has spent close to Rs 90 crore in building its facilities in the past three to four years. It is expanding its vaccines portfolio too. Besides DPT, TT and Hepatitis B, it sees an opportunity in Japanese Encephalitis (JE) vaccines. It entered into an agreement with Intercell AG, a US-based biotechnology company, for the development, manufacture and sale of its new Japanese Encephalitis vaccine in Asia. Biological E will manufacture the product in India for the Asian endemic market, while Intercell AG would market the product in the US, Europe and Australia. It is looking at Hib vaccines for influenza too. ]]> <![CDATA[Bharat Biotech International]]> https://biospectrumindia.com/news/95/2817/bharat-biotech-international.html https://biospectrumindia.com/news/95/2817/bharat-biotech-international.html Thu, 15 Jun 2006 15:00:00 +0530 Throughout the year 2005 Throughout the year 2005-06, one saw Hyderabad-based Bharat Biotech International (BBIL) announce new initiatives. It launched products like REGEN-D, a specialized therapeutic for diabetic foot ulcers, burns and skin grafts. It established a manufacturing and marketing agreement with Acambis Plc, relating to Acambis' ChimeriVax-JE investigational vaccine against Japanese Encephalitis. Novavax Inc. and BBIL announced a strategic alliance to pursue the rapid development of pandemic influenza vaccine. Under the terms of the agreement, Bharat Biotech will fund all preclinical and clinical development, work with Novavax on optimal manufacturing processes, and be responsible for the commercialization of the vaccine. In return Novavax will receive unrestricted access to all preclinical and clinical data, and a royalty on all sales. Also it proposed to set up an overseas plant in Perak, Malaysia to produce vaccines for typhoid and Hepatitis B, besides other recombinant products. Dr Krishna M Ella, chairman and managing director, said it would be investing about RM50 million in the new plant's manufacturing, and research and development divisions. Bharat Biotech signed a memorandum of agreement with Remco Engineering and Consultancy Sdn Bhd and Perak Development Corporation (PDC) towards this. These developments will take some time to fructify. These actions have been in line with its focus-work on novel products, tap contract manufacturing and research opportunities and produce biogenerics. As part of that strategy, BBIL has an internal marketing team with all India presence and has export activities through partners. BBIL has ongoing marketing alliances with companies like Intas, Lupin, Nicholas Piramal, Wockhardt, and VHB. BBIL in 2005 did a total biotech business of Rs 48.1 crore, a growth of over 26 percent over that in 2004-06. It is a leading player in the vaccines for prevention against Hepatitis B and typhoid. It has a strong contract manufacturing focus too. It is the first company in the country to be approved by Korean FDA for manufacture of biologicals. It manufactures HibTITER for Wyeth too. BBIL expects to witness over 40 percent growth during 2006-07. ]]> <![CDATA[Wockhardt]]> https://biospectrumindia.com/news/95/1789/wockhardt.html https://biospectrumindia.com/news/95/1789/wockhardt.html Thu, 15 Jun 2006 14:56:00 +0530 Resolute Preparedness Resolute Preparedness Despite its biotech revenues falling short of expectation, Wockhardt hopes to get close to the Rs 100-crore projection at least this year. Wockhardt's biotechnology business, carved out into a separate strategic business unit in 2005, crossed the Rs 45 crore ($10 million) mark in sales for year ending December 2005 registering a growth of 54 percent. And for year 2005-06, its biotech sales touched Rs 49.75 crore, belying its projection of Rs 100 crore. The Mumbai-based drug maker hopes to get close to the Rs 100-crore projection at least this year, with Wockhardt top-management expecting to clock $20 million (about Rs 92 crore) as revenues in the biotech segment for 2006. According to Habil Khorakiwala, Wockhardt chairman, the biotech performance for the year at $10 million, was "below the expectation". The company's biotech products â€“ Wosulin and Wepox are doing well in the market. Wepox became the No.1 prescribed brand during the year while Wosulin was the highest prescribed amongst the new prescriptions with a market share of over 40 percent. During 2005, Wockhardt launched in India a new generation Hepatitis A vaccine under the brand name Biovac-A in collaboration with Zhejiang Pukang Biotechnology Company Ltd of China. The vaccine has been priced at Rs 1,100 per dose. Wockhardt is looking at capturing 20-25 per cent of this Hepatitis A vaccine market in India over a period of 12 months. Besides marketing in India, Wockhardt is reported to be marketing Biovac A, in Bangladesh, Pakistan and Vietnam for Zhejiang Pukang, the innovator company. In addition to launching Biovac A, Wockhardt launched India's first automatic insulin delivery device (Wosulin pen and cartridge) in early 2005. Close on the heels of introducing Biovac A vaccines, Wockhardt is contemplating on a strategy of licensing with global vaccine companies for introducing other vaccines into India. It is working on a host of new vaccines for infectious diseases, which are expected to be launched in 2008. Wockhardt's biopharmaceutical business in the global markets commenced during 2005. The focused approach through creation of separate SBU has had an all-round impact on all aspects of biopharmaceutical business. These markets offer huge opportunities for Wockhardt as several high-value biotech medicines are due to come off patent in the next few years, offering opportunities to launch cost-effective versions with the potential of reaching more needy patients across the world. It has also commenced filing for registration of its insulin cartridges in unregulated markets. Wockhardt also became the first Indian company to be registered for doing business with Gulf Cooperation Council (GCC) countries. Wockhardt's biotech products have received 30 overseas registrations spread over 18 countries. Meanwhile Wockhardt UK has launched natural insulins in Canada after its approval by Health Canada authorities. Wockhardt has launched Wosulin in three countries. It is received the first overseas approval for Wosulin cartridges. Wockhardt invested Rs 104 crore, amounting to 7.4 percent of the turnover, in R&D during the year. Its new drug discovery program has yielded several promising new molecules. ]]> <![CDATA[Advanced Enzyme Technologies]]> https://biospectrumindia.com/news/95/2551/advanced-enzyme-technologies.html https://biospectrumindia.com/news/95/2551/advanced-enzyme-technologies.html Thu, 15 Jun 2006 14:55:00 +0530 Catalytic Mover Catalytic Mover Advanced Enzyme Technologies has in its basket hundreds of unique enzyme solutions derived from natural origins. Advanced Enzyme Techno- logies Ltd (formerly A vanced Biochemicals Ltd) has consolidated its position by registering a growth of 41.59 percent over last year. Last year it witnessed a growth of 31.4 percent. Its sales have increased to Rs 56 crore during 2005-06 against previous year's sales of Rs 39.55 crore. Still, for Advanced Enzyme Technologies, last year was a year of development. It focused on product and process developments. The team at Advanced Enzyme Technologies worked on the program for the Organic Certification, detailed the documentation and process parameters and successfully complied for the SKAL International Audit for Organic Certification and received the organic certificate for its agriculture bioproduct AgroSEB â€“ an organic bio enzyme. It also received SKAL certification for its EnviroSEB product being certifying it to be an organic product. With this, Advanced Enzyme Technologies has joined the SKAL International Program for Organic Certification for its agriculture product AgroSEB (Unique Biological Yield and Quality Enhancer) that originates from organic cultivate and are processed using organic methods. As one of the key players in biotech industry, Advanced Enzyme Technologies has been making efforts to keep its operations upgraded and keep up with the ever-increasing standards by elevating the strength of its human resource. Its operations are widely spread in different segments of industries such as food, leather, textile, animal nutrition, nutraceuticals and pharma. Advanced Enzyme Technologies has acquired a breakthrough in prevention therapy in course of nutraceuticals research. Its nutraceuticals range of products are capable of finding solutions for preventing diseases like TB, leprosy, obesity, cancer and cardiovascular disease. With an objective to constantly develop new enzymes-based customized products for industry without any side effects, it has set up new R&D facility at Thane at an investment of Rs 7 crore. It has increased its R&D investments from five percent to nine percent of its total sales. Its multi-disciplinary R& D team consists of microbiologists, biochemists, chemical engineers, food technologists, and biotechnologists with several years of experience with enzyme technology. Through continuous R&D, it is developing a rapidly expanding range of products and services. Its extensive biotech experience has led to the development of hundreds of unique enzyme solutions addressing the needs of customers in 25 industries i.e. from health care to starch processing and breweries and distilleries to textiles and over 30 countries. Advanced Enzyme Technologies products have been analyzed and screened by competent regulatory organizations and have answered required qualitative tests. One of its products used for coffee effluent treatment was tested through Karnataka Pollution Control Board, the results of which were very promising. A product for sewage treatment has also been successfully developed and commercialized through the Delhi Jal Board. It has come up a new product for leather segment that helps in reducing the pollution as it reduces the usage of lime, sulphide and solvent. Advanced Enzyme Technologies, which entered the markets of China, Bangladesh and Turkey in 2004-05, is now exploring the European market too. Considering the market potential and growth of the market, it is expanding its production capacity by setting up two more new plants, one in Madhya Pradesh and second one in Maharashtra with total additional investments of Rs 45 crore. ]]> <![CDATA[Intervet India]]> https://biospectrumindia.com/news/95/1534/intervet-india.html https://biospectrumindia.com/news/95/1534/intervet-india.html Thu, 15 Jun 2006 14:51:00 +0530 Animal Health Promoter Animal Health Promoter With an extensive range of high value-added products for farmers and veterinarians, Intervet India is a leader in the animal health market Intervet India's biotech sales stood at Rs 65.52 crore of the total sales of Rs 84 crore for the calendar year 2005. Intervet India' offers a range of products comprising biologicals (livestock, companion, poultry live and inactivated), therapeutics (antiprotozoan, antibiotic, ectoparaciticides, endoparaciticides, suppotives), productive hormones and feed additives, covering dogs, cats, pigs, camels, poultry, cattle, sheep, goats and horses. Intervet India is the largest multinational in India dedicated to animal healthcare. Intervet India is the result of autonomous growth and subsequent mergers of well-known and leading companies like Hoechst RousselVet (HRVet), Intercare and BAIF's Animal Health Division. Intervet India Pvt Ltd was established in 1997 in Hyderabad with poultry vaccines, canine products and fertility hormones. In 1999, the International merger between HRVet and Intervet International resulted in the merger between HRVet India and Intervet India in the year 2000. In 2004, it shifted base to Pune and extended its production and supporting operations for the biological segments. Intervet India has a manufacturing and R&D site in Pune for FMD, other veterinary biologicals, pharmaceuticals and feed additives. Its operations in Pune are part of Intervet International's network and hence the company has access to the latest technology. Intervet India complies with Indian and International standards like WHO and GMP and is ISO 9001 certified. Distribution of Intervet's products takes place through a network of 20 agents ensuring cold chain maintenance and subsequent distribution through 900 distributors. It also exports its products to other countries in Asia, Europe, Latin America and Africa. It has become a partner in government livestock improvement programs like FMD Eradication. It has over a 100 technically well-trained field employees supporting farmers and veterinarians in disease prevention and livestock improvement. Intervet India responded to an urgent plea for help from the government of India after an outbreak of foot and mouth disease threatened to devastate livelihoods on the tsunami-ravaged Andaman Islands. In December 2005 Intervet signed a memorandum of understanding (MoU) to exclusively supply veterinary products and to set up a livestock disease diagnostic and healthcare center for a special project in India to support rural families. The company has entered into a partnership with Indian NGO, BAIF Development Research Foundation, where in Intervet India will provide products to BAIF, which will make them available to small-scale farmers via their extensive network of dairy cattle breeding centers (CBC). A number of livestock disease diagnostic centers will also be established. BAIF and Intervet India (part of Intervet International) will work together to improve disease management and productivity at the rural level and promote livestock healthcare awareness. The partnership will offer self-employed farmers in remote villages access to vital veterinary products at a fair price. The agreement with BAIF will begin with a three-month trial in Gujarat and Karnataka, where around 2,50,000 families will have access to Intervet India's livestock range, including vaccines and anti-infectives. Once the trial is over, an evaluation and fine-tuning will take place. The project will then be extended nationwide to cover all the CBCs. Considering the initiatives taken by Intervet India in the welfare of the local community, The Netherlands-based Akzo Nobel, its parent company has awarded it with its inaugural Corporate Social Responsibility Award in recognition of its involvement and dedication to the local community in 2005. Intervet India was lauded for the diversity and sheer scale of its involvement in the local community which included free FMD vaccination for 8,000 animals around Intervet's premises, the donation of computers and furniture to local schools, recycling water to overcome water shortages and the children's helmet project to encourage parents make their children use helmets while riding pillion. ]]> <![CDATA[Bharat Serums and Vaccines]]> https://biospectrumindia.com/news/95/4410/bharat-serums-and-vaccines.html https://biospectrumindia.com/news/95/4410/bharat-serums-and-vaccines.html Thu, 15 Jun 2006 14:49:00 +0530 Plasma Maker Plasma Maker Bharat Serums and Vaccines holds a formidable market share in India for plasma derivatives and is constantly expanding its range of products. It was a strategic decision at Bharat Serums and Vaccines Ltd (BSV) to expand its existing biological facility considering a double-digit growth for biologicals in the coming years, following which its biological unit was partially shut down. Its effect can be seen on its sales that have seen a negative growth of 3.64 percent with its biotech sales for 2005-06 recording Rs 78.05 crore against last year's sales of Rs 81 crore. During 2004-05, Bharat Serums and Vaccines registered a marginal growth of 1.66 percent over the previous year's sales of Rs 79.68 crore. Bharat Serums and Vaccines, a flagship company floated by Dr Vinod G Daftary, received a total sum of Rs 10.48 crore for two of its projects costing Rs 7.07 crore and Rs 3.41 crore from Department of Science and Technology, Government of India, as loan for research and development work pertaining to medicines. Besides this, BSV is investing about seven percent of its total revenue in R&D infrastructure including high quality laboratory facilities, experienced research scientists and personnel. The R&D activities have been granted recognition by the Department of Scientific and Industrial Research. BSV has distinct R&D divisions working extensively on New Drug Discovery System (NDDS) and biotechnology. It has developed its competency in the areas of NDDS and in development and purification of equine-based therapeutic products. On the biotechnology front, the team has been working on developing new generation recombinant therapeutics that replace the traditional plasma products which are in short supply worldwide due to the dependence on human donors, and runs the risk of viral infections like HIV etc. It has an in-house expertise to conduct genetic engineering, process development and scale-up activities in the biotechnology space. Bharat Serums and Vaccines has set up a joint venture company with Cadila Healthcare Ltd to produce a NDDS for an approved anti-cancer product for the global markets. The 50:50 joint venture company will develop, manufacture and market a non-infringing and proprietary NDDS. As per the agreement, both companies will undertake a core development program and are initiating clinical trials for product registration in leading pharmaceutical markets for potential treatment of multiple types of cancer. Cadila Healthcare and Bharat Serums have also evolved a global development program to maximize the commercial potential of the product. During 2005, Bharat Serums and Vaccines received a US patent for one its novel formulation, Amphotericin B Emulsion. All the excipeints used for this formulation are US FDA approved for injectable formulations. BSV has already received the marketing permission for this drug in India for Visceral Leishmaniasis and is in process of conducting clinical trials for obtaining the permission in treatment of fungal infections. BSV has also conducted a Pre IND meeting with the US FDA for the clinical path and is in process of filing the IND by Quarter I 2006. BSV expects that a safer Amphotericin formulation would be in a position to capture a substantial share of the global anti-fungal market. Bharat Serums and Vaccines that imports blood products from Human Serums Production & Medicine Mfg. Co. Ltd. Hungary, Hardis Spa., Italy , Hematalog Ltd., Russia and Grifols, USA, commissioned a new state-of-the-art injectibles manufacturing plant at Ambernath in 2002. The plant has been constructed as per the guidelines of the UK-MCA to enable access to European markets. The design and the engineering of the facility has been developed to enable the manufacture of the products in accordance with the best international GMP. It has also been accorded the WHO-GMP certification. Its plants have got the approval and accreditations from WHO and DGCI to manufacture pharmaceutical products. A marketing team of 20 individuals at BSV supports the sales team of over 300 managers, executives and medical representatives who cover the length and breadth of the country. BSV is able to cater to over 100,000 retail outlets and hospitals all over the country. It has also appointed distributors in over 30 countries for various products to enable continuous availability of its products in these countries. ]]> <![CDATA[Shantha Biotechnics]]> https://biospectrumindia.com/news/95/1255/shantha-biotechnics.html https://biospectrumindia.com/news/95/1255/shantha-biotechnics.html Thu, 15 Jun 2006 14:48:00 +0530 Pioneering Spirit Pioneering Spirit The ride on Hep B continues. Hyderabad-based Shantha Biotechnics had yet another impressive year. The company recorded 23.85 percent growth to register Rs 82.26 crore in biotech revenues. The bulk of its business came from sale of Hepatitis B vaccine. The Hepatitis B vaccines sales in 2005-06 stood at Rs 79.52 crore, up from the previous year's business of Rs 61.80 crore. It sold about 658 lakh PDS of Hepatitis B vaccine during the year. The sale of therapeutics including erythropoietin, interferon, streptokinase and growth factors stood at Rs 2.7 crore during FY 2005-06. The company had launched its erythropoietin, Shanpoietin, and streptokinase, Shankinase in 2004-05. It also launched some traded products in the oncology segment like Epirubicin injections. A major reason for its growth has been increase in export orders and increase in the utilization of the facility. During FY06, its exports accounted for 87 percent of the total business, while the exports in 2004-05 accounted for 69 percent of its revenue and stood at Rs 46 crore. It mainly exports its Hepatitis B vaccines. It supplies these vaccines in international markets including Asia-Pacific, Africa, CIS and Latin America in addition to supplies to global organizations like UNICEF and PAHO. The company has built up a strong network of business partners in many key markets. One of the major developments during year has been the launch of its four-in-one vaccine, Shantetra, in August 2005. This product was also jointly awarded the BioSpectrum Product of the Year 2005 in December. An indigenously developed and produced vaccine, it protects children against four life-threatening infections-Diphtheria, Tetanus, Pertussis and Hepatitis B and has to be given to children from six weeks of age onwards. It set up a DPT plant in September 2004, investing Rs 34-35 crore on it. It can manufacture 215 million doses of DPT annually and 150 million doses of the combined vaccines. This vaccine has been competitively priced in the market at 30 percent less than the leading MNC brand. For a single dose presentation, it costs about Rs 80. It will be coming out with the Hib quadravalent (DTP-Hib) and Hib pentavalent (DTP-Hepatitis B-Hib) by second half of 2006. Shantha is conducting phase III clinical trials of r-DTwPHb-Hib Pentavalent Combination Vaccine. Shantha Biotechnics received the green signal from the Genetic Engineering Approval Committee (GEAC) at its meeting held on November 23, 2005. Pentavalent Combination Vaccine is for paediatric use in immunization program. Pentavalent vaccine contains Diphtheria (D) and Tetanus toxoids (T) and the purified major surface antigen of the hepatitis B virus (HBV), Hib polysaccharide adsorbed on aluminum salts and mixed with inactivated whole cell pertussis (P). The Review Committee on Genetic manipulation (RCGM), which has examined the pre-clinical animal toxicity studies, noted that the product is found to be safe. It plans to come out with an anti- RHD and viral vaccine in 2007, and launch therapeutic monoclonals in 2008. Shantha has a strong R&D focus. Out of the total staff strength of about 700, there are 115 employees working on the research side. It invested close to 10 percent of its revenues in R&D activities. Its R&D center is spread over an area of 40,000 sft and its R&D efforts are mainly focused on therapeutic products for oncology and on vaccines. Shantha also has a subsidiary, Shantha West Inc. in San Diego, USA, which is engaged in basic research in monoclonal antibodies for therapeutic applications in the oncology segment. ]]> <![CDATA[Eli Lilly And Company (India)]]> https://biospectrumindia.com/news/95/1946/eli-lilly-and-company-india.html https://biospectrumindia.com/news/95/1946/eli-lilly-and-company-india.html Thu, 15 Jun 2006 14:44:00 +0530 Effective Innovator Effective Innovator Lilly's innovative products have been an answer to the needs of the people suffering from various diseases. Eli Lilly introduced the world's first genetically en- gineered biotech product for treatment of diabetes-recombinant human insulin or "Huminsulin". Today, this has become the flagship brand of Eli Lilly in the country. A major chunk of Lilly India's revenue is attributed to its human insulin product portfolio, which includes Huminsulin, currently available in a wide range of formulations: Humalog (Injection Insulin Lisprol), a fast acting insulin analog useful for diabetics with a hectic lifestyle, Humaject, a use and throw disposable insulin delivery device and HumaPen Ergo, a virtually painless way of injecting insulin. The company's other products in the biotech domain are Humatrope (Injection Somatropin-growth hormone) for growth hormone deficiency syndrome, which is currently available as HumatropePen and Forteo (Injection Teriparatide) for severe osteoporosis. According to industry estimates, Lilly India has done business worth of about Rs 85 crore in 2005-06 in the biotech segment. With a motto to provide "Answers That Matter", Lilly focuses its internal research efforts primarily on six core therapeutic areas: neuroscience, endocrine disorders, cancer, infectious diseases, cardiovascular diseases and gene regulation, bone and inflammation. In the last decade, Lilly has introduced new important drugs for the treatment of cancer, schizophrenia, osteoporosis, diabetes, cardiovascular complications and most recently, severe sepsis. These include Xigris (Injection Drotrecogin Alfa), the only treatment available for the reduction of mortality in adult patients with severe sepsis, Gemcite (Injection Gemcitabine) for the treatment of non-small-cell lung, pancreatic, bladder and breast cancer, Distaclor (tablet Cefaclor), a broad-spectrum antibiotic to treat tough infections and ReoPro (Injection Abciximab), a supportive therapy used during interventional cardio vascular procedures. In India, the company operates through a team of 550 individuals, which is based across the country and provides products and services to medical practitioners and hospitals. Lilly is presently conducting about a dozen trials of its different products, which are in the various stages of development in India and more than 20 of its professionals are engaged in clinical research. Its annual investment in clinical research accounts for more than 8 percent of the sales turnover. Recently there have been top level management changes at Lilly India. Rajeev Gulati, the erstwhile CMD of Lilly India, has moved to the US pharma major's corporate office in Indianapolis for an international assignment while Sandeep Gupta, operating from Lilly's Philippines office, has moved to Delhi to take charge of the Indian operations. At present, the company is working on an expansion strategy to build its presence in the country. It is believed that Lilly will be conducting the phase III clinical trials of its new pulmonary insulin molecule in India, which will be part of some select regions worldwide, including the US. The company is also planning to introduce some more products in India in the near future. Initially, Eli Lilly and Company was set up as a 50:50 joint venture between Eli Lilly and the Indian partner Ranbaxy Laboratories. After its inception in 1993, the Indian operation achieved a quick break-even in 1996. In August 2001, Eli Lilly and Company acquired the 50 percent stake from Ranbaxy Laboratories to create a 100 percent Lilly subsidiary, Eli Lilly and Company (India) Pvt. Ltd. ]]> <![CDATA[GlaxoSmithKline Pharma]]> https://biospectrumindia.com/news/95/1727/glaxosmithkline-pharma.html https://biospectrumindia.com/news/95/1727/glaxosmithkline-pharma.html Thu, 15 Jun 2006 14:43:00 +0530 Jaundice Slayer Jaundice Slayer GSK embarks on disease awareness campaign to capture the market. GlaxoSmithKline (GSK) Vaccines continued to lead the Indian vaccines market by registering a growth of 20.79 percent with its sales reaching Rs 94.00 crore for the year 2005-06. GSK had registered sales of Rs 77.8 crore for the year ending March 31, 2005, up by about 27 percent on 2004-05. In India, GSK leads the represented vaccine market with a 51 percent market share. GlaxoSmithKline in India, an affiliate of GlaxoSmithKline Biologicals (GSK Biologicals), is setting up a state-of-the-art vaccines filling facility at Nasik conforming to international current Good Manufacturing Practices (cGMP) norms. The foundation for this plant was laid in February 2005 and is expected to be fully operational during 2006. This facility will be GSK's first manufacturing site to co-house a pharmaceutical and vaccine manufacturing. The plant is being built to cater to the Indian market needs, which could be expanded to meet the requirements of neighboring countries. The creation of this plant demonstrates GSK's commitment to India. To address the growing competition from local players, GSK Vaccines has initiated novel concepts to spread awareness on the use of vaccines in the country. For example, 'Famili Vaccines' is an immunization awareness initiative launched last year. 'Koi Hai' is an education program on Hepatitis A. These programs aim at creating awareness and educating the public on the disease, thereby enabling people to protect themselves against it. This program entails social interventions at the workplace, in schools and in clinics that reach out to the various segments of audiences. Continuing with its initiatives in bringing awareness on vaccinations, GlaxoSmithKline has introduced HEPPOs, a public awareness initiative to combat the incidence of jaundice (hepatitis)-Jaundice ke dushman and liver ke dost. These lively, adorable characters provide vital information to help people protect their liver, their life and their loved ones from two of the most prevalent causes of jaundice. Through the HEPPOs, GlaxoSmithKline reintroduces its bouquet of hepatitis vaccines-for Hepatitis A, Hepatitis B and a combination vaccine for Hepatitis A&B, namely, Havrix, Engerix-B and Twinrix. GlaxoSmithKline has introduced the second phase of Suraksha Kavach program with a nationwide initiative to educate school children on chickenpox, a highly infectious disease, caused by the Varicella zoster virus, which results in a blister-like rash, itching, tiredness and fever. GlaxoSmithKline 's initiative aims to improve disease awareness, highlight prevention method and dispel myths that still persist about chickenpox. Suraksha Kavach will drive awareness about protection against disease and wellness for individuals, families and society at large. During early 2006, GlaxoSmithKline announced the forthcoming launch of the vaccine Boostrix comprising Acellular Pertussis reduced, Diphtheria Toxoid reduced and Tetanus Toxoid (dTpa) in India. Boostrix has been registered for use in children over the age of four years, who have already received their primary DTP doses in the first and second year of life. Currently Boostrix is the only globally approved acellular pertussis boosting vaccine for all age groups. GSK Biologicals has identified India as a major center for clinical research across a number of disease areas. GSK India has been supporting GSK Biologicals in its vaccines development process through its clinical data management center based in Bangalore for the last 10 years. ]]> <![CDATA[Indian Immunologicals]]> https://biospectrumindia.com/news/95/1555/indian-immunologicals.html https://biospectrumindia.com/news/95/1555/indian-immunologicals.html Thu, 15 Jun 2006 14:42:00 +0530 Bovine Expert Bovine Expert Established by the NDDB in 1983 to provide affordable FMD vaccines, IIL today operates the world's largest plant for veterinary vaccines. Indian Immunologicals Ltd (IIL) is one of India's leading players in the animal health care business. Not just that, today it has expanded beyond being an animal healthcare company by adding human vaccines too. It is one of the major suppliers of rabies vaccines. Now, one of its arms, Human Biological Immunological, announced that it would manufacture and market r Hepatitis B vaccines in India subject to DCGI clearance. Human Biological Immunological has completed the conduct of phase III clinical trials in accordance with the approvals granted by the Genetic Engineering Approval Committee (GEAC) and DCGI. The committee concluded that the containment facilities at the R&D and production premises of Human Biological Immunological are adequate to meet the environmental safety regulation for production of r-Hepatitis B vaccine. Clearly, it is now one of the top vaccines makers in the country. The company reported a total business of Rs 102 crore in 2005-06, recording 41.85 percent growth compared to the previous year's sales of Rs 83 crore. While its animal healthcare business accounted for Rs 75.67 crore in 2005-06, the same for human health care vaccines was Rs 27 crore. Indian Immunologicals is a wholly owned subsidiary of the National Dairy Development Board (NDDB) and was set up in 1983, under the "Operation Flood" program to meet the growing demand for Foot and Mouth Disease (FMD) vaccine in India. And it is the first veterinary biological unit in India to obtain both ISO 9002 and Good Manufacturing Practices (GMP) certification as per World Health Organization (WHO) GMP guidelines. IIL manufactures a wide range of animal health products and is a world leader in Foot and Mouth Disease (FMD) vaccines. It has an installed production capacity of 25 million quadrivalent doses of FMD vaccine, which is the largest in Asia and the second largest in the world. Its FMD flagship is called Raksha. The technical know-how for the production of "Raksha" Foot and Mouth Disease Vaccine was obtained from the Wellcome Foundation Ltd. It also has a strong research focus. As a result of this focus, IIL has brought out several preventive veterinary products like theileriosis vaccine, rabies tissue culture vaccine, oil adjuvant FMD vaccine and combined canine vaccines. IIL today exports its products, especially vaccines, to several countries in Asia, the Middle East, Africa and Cyprus in Europe. In 2005-06, IIL's exports stood at Rs 8 crore. The company spends close to 5 percent of its revenues on R&D. It has filed for three patents in 2005-06 of which one has been for a new non-steroid anti-inflammatory drug and a novel combination DNA rabies vaccine. The success of the company is on account of it innovative reach and services. For example, IIL entered into an agreement with Cooperative Resources International (CRI), the US-based largest cooperative breeding company, to provide advisory services aimed at improving the Indian livestock economy. The joint venture company, IndiaGen, is considered the first such venture. It aims to provide farmers with genetics and advisory services to optimize productivity and help reduce cost of milk production. IIL has three strategic business units: Institution (government, co-operatives/milk-unions), Livestock and Petlife. IIL has distribution points at 16 locations in India. ]]> <![CDATA[Aventis Pharma]]> https://biospectrumindia.com/news/95/1507/aventis-pharma.html https://biospectrumindia.com/news/95/1507/aventis-pharma.html Thu, 15 Jun 2006 14:40:00 +0530 Rabid Terminator Rabid Terminator Rabipur drives Aventis' biotech aspirations. Aventis Pharma Ltd continued to lead the anti-rabies vaccine market in India registering a growth of 15 percent over the previous year. Aventis Pharma markets the rabies vaccines under the brand Rabipur. It continues to be the market leader with a market share of 69 percent. Rabipur crossed the figure of Rs 100 crore in November 2005 (for the calendar year 2005) becoming the first brand to achieve this milestone. Besides vaccines, it is also into insulin business with its product Lantus. Its overall biotech sales for year 2005-06 reached Rs 114.5 crore against last year's sales of Rs 84.3 crore. Besides Rabipur, Aventis sells other vaccines such as Vaxem HIB, Morupar and Typhoral. Lantus is a star in its portfolio for diabetes treatment in India. It was introduced in the last quarter of 2003. Lantus is the first 24-hour basal (long acting) insulin in India for both Type 1 and Type 2 diabetes. Lantus, the world's first long active Insulin glargine, achieved excellent acceptance by diabetologists and patients. It continues to drive the growth of basal insulin in the country. Lantus is growing faster than the human insulin market (18.7 percent) and the basal insulin market (48.6 percemt). Campaigns for patient acquisition through the year have helped in getting new patients on Lantus thereby ensuring better diabetes control. Though it is not actively involved in R&D of its own in India, it has access to the Group's global research initiatives and has an impressive line-up of blockbusters in the pipeline. Although Aventis Pharma does not conduct any basic research, it has carried out process development and clinical trials for existing and future products. And has earned a total revenue of Rs 334 lakh. It has conducted the first wave of a large-scale practice survey of diabetes management across the country. This survey will help identify the various methods of diabetes management being practiced in the country to help provide better healthcare in the management of diabetes. An observational study of gastric cancer treatment regimes was also initiated in 2005 with some of the leading oncologists. This study will continue in 2006 aiming to study the treatment options used in this type of cancer. Aventis Pharma is managing two studies with its product Clexane to assess its effect in preventing formation of clots in immobilized patients. It has also conducted an interesting study on use of the 'once a day' basal insulin Lantus in fasting patients to demonstrate its safety. Throughout the year, large number of Continuous Medical Education programs were held in different therapeutic categories to disseminate latest scientific advancements. Aventis Pharma has six regional offices and two state-of-the-art manufacturing sites at Ankleshwar (active pharmaceutical ingredients and formulations) and Goa (formulations). Incorporating the latest designs and processes in manufacturing, both sites have been identified as potential global sourcing units. Its Ankleshwar site is shared with Chiron Behring Vaccines Pvt Ltd (CBVPL) and Aventis CropScience. The CBVPL is a joint venture company in which Aventis is holding 49 percent stake. As per the agreement, CBVPL will manufacture Rabipur, anti-rabies vaccines for Aventis Pharma upto April 2008. Four of its products including LANTUS and INSUMAN continue to be fully exempted from customs duty as they are in the exemption list of life saving medicines. There will also be no special countervailing duty on these products. These would help the company to increase its sales in insulin market space in the country. ]]> <![CDATA[Mahyco Hybrid Seeds Company]]> https://biospectrumindia.com/news/95/3829/mahyco-hybrid-seeds-company.html https://biospectrumindia.com/news/95/3829/mahyco-hybrid-seeds-company.html Thu, 15 Jun 2006 14:35:00 +0530 The Introducer The Introducer The market dynamics catch on Mahyco. Despite an uproar in Andhra Pradesh over sale of its Bt cotton seeds, Mahyco Hybrid Seeds Company Ltd (Mahyco) managed to sell 9.2 lakh packets of Bt cotton hybrids in the 2005 Kharif season in India. This is slightly less than its 2004-05 sales of 10.36 lakh Bt cotton packets. However, its revenues from the sale of Bt cotton hybrids for 2005â€“06 showed a 29 percent drop. It recorded Rs 117.76 crore through Bt cotton sales. The drop in sales revenue is not just because of drop is number of packets but also due to 25 percent reduction in the price for its Bt hybrid packets to Rs 1,280 per packet in 2005 Kharif season. Mahyco, the first Indian company to commercially grow and market transgenic Bollgard cotton, continued to focus on R&D in agribiotechnology. This helped it to receive a green signal from the Genetic Engineering Approval Committee (GEAC) for commercial cultivation of two of its hybrids-MRC-6025 and MRC-6029 containing Cry 1Ac gene Mon 531 event in the North zone for a period of three years starting from 2006 Kharif season. With this, it has added two more Bt hybrids seeds to its list of seven Bt cotton hybrids, which got approval till 2005 Kharif season. So far the farmers in north zone of the country were cultivating MRC 6304 and MRC 6301 hybrids and in central zone Mech 12, Mech 162 and Mech 184 and in south Mech 162*, Mech 184*, MRC 6322 and MRC 6918 (* not approved for commercial cultivation in Andhra Pradesh). Besides, it has also received approval from the GEAC for large-scale trials and seed production of transgenic cotton hybrids for MRC 7347 BGII and MRC-7351 BGII containing stacked genes Cry1 Ac and Cry 2Ab (event MON 15985) in the central zone during Kharif 2006. Mahyco has developed a fruit and shoot borer resistant eggplant under a public private partnership program, Agriculture Biotechnology Support Project II (ABSPII) in part supported by USAID, ICAR, DBT, partner institutions and coordinated by Cornell University. The project includes East West Seeds Ltd of Bangladesh, Bangladesh Agricultural Research Institute and Institute of Plant Breeding, College of Agriculture, University of Philippines as the other partners. As part of the MoU, it has been agreed to provide the Bt brinjal technology for development of pro-poor varieties of brinjal to Bangladesh and Philippines. And Mahyco has also received the GEAC approval to export transgenic eggplant seeds to the Institute of Plant Breeding, College of Agriculture, University of Philippines and Bangladesh Agriculture Research Institute, Bangladesh, provided these germplasm were initially brought from these countries only. Mahyco has many firsts to its credit. It is the first private enterprise in the country to produce and market hybrids of cotton, sorghum, pearl millet, sunflower and wheat. It is also engaged in the research, production, processing and marketing of about 115 products in 30 crop species including cereals, oilseeds, fibre and vegetables. Mahyco is also developing genetically enhanced crops with the use of gene transfer technology. Mahyco has a national presence with its network across the country. Mahyco established a new research facility, the Mahyco Research Center, near Jalna-Aurangabad, Maharashtra in 1998, to conduct cutting-edge biotechnology research in a number of areas relevant to crop improvement and productivity, while still remaining close to its roots in rural agriculture and seeds research. Major research areas include crop transformation, molecular virology, molecular microbiology, gene discovery and molecular markers, entomology and diagnostics. To monitor the trait protein content in genetically modified (GM) crops, it has established DesiGen Diagnostics that provides diagnostics solutions for GM crop testing. ]]> <![CDATA[Novo Nordisk India]]> https://biospectrumindia.com/news/95/2677/novo-nordisk-india.html https://biospectrumindia.com/news/95/2677/novo-nordisk-india.html Thu, 15 Jun 2006 14:34:00 +0530 Diabetes Defeater Diabetes Defeater Novo Nordisk has the broadest diabetes product portfolio in the industry, including the most advanced products within the area of insulin delivery systems. A midst competition from the local companies and selling at competitive price, Novo Nordisk India Pvt Ltd continued to lead the Indian human insulin market with a share of over 65 percent. Its sales revenue during 2005-06 registered a growth of over 44 percent to Rs 195 crore against last year's sale of Rs 135 crore, which is higher than the growth of the insulin market in India. The company says that the growth is mainly because of the competition in the local market, which has brought about increased awareness among diabetics on the use of therapeutic products. In May 2006, Novo Nordisk India launched its long-acting insulin Levemir in India to aid glycaemic control for people with Type 1 and Type 2 diabetes cases in the country. The insulin is delivered to the patient through a pen-like mechanism. Novo Nordisk's FlexPen is priced at Rs 930 for a 300 ml pen, on par with other analogues in the market. Levemir is a novel predictable basal insulin analogue with a unique mechanism of prolonging action. A fatty acid attached to the insulin molecule enables Levemir to bind the albumin that helps maintain the blood glucose levels in a predictable range. As part of the launch efforts, Novo Nordisk has increased its sales force that will cover over 30,000 doctors manning diabetic clinics in the country to recommend the use of the new basal insulin over traditional therapies. Novo Nordisk India will import Levemir from Denmark. The company expects to capture one-fourth of India's basal insulin market in the year 2007. Besides marketing a portfolio of therapeutics products like NovoPen 3, Novolet and Flexpen, Novo Nordisk is set to conduct three global clinical trials during 2006 in India on future products. The company has two ongoing trials and is looking at conducting three more trials during 2006. The clinical studies would be phase III trials for GLP-1 analog products, used in the treatment of diabetes. It will be conducted on close to 200 patients at sites across the country. Novo Nordisk India has entered into an agreement with TCS, for the implementation of an offshore clinical operations service. TCS will provide a suite of data management services, which include designing, capturing, and coding of trial data gathered from clinical trials that are run by Novo Nordisk across the world, out of its modern BPO facility in Mumbai. Novo Nordisk is actively working on its outsourcing strategy and already has a number of agreements in place in India. Novo Nordisk India also signed an agreement with Torrent Pharma in August 2005 to establish a new and dedicated formulation and packaging facility for Insulin, exclusively for Novo Nordisk. The facility will cater to the increased demand for Novo Nordisk Insulin products in India and will incorporate state-of-the-art technology in formulation, filling, inspection and packaging of Novo Nordisk insulin formulations. The new plant would meet Novo Nordisk India's estimated requirements in the future. All of NN vial formulations for the Indian market are expected to be manufactured at Torrent's facility. Torrent is the sole manufacturer of Insulin Formulations for Novo Nordisk in India. The domestic formulation at Torrent Pharma will be done with the same state-of-the-art technology and quality standards as practiced across the world by Novo Nordisk. Novo Nordisk India along with Torrent was one of the first companies in the country to initiate formulation of Human Insulin. ]]> <![CDATA[Venkateshwara Hatcheries]]> https://biospectrumindia.com/news/95/6820/venkateshwara-hatcheries.html https://biospectrumindia.com/news/95/6820/venkateshwara-hatcheries.html Thu, 15 Jun 2006 14:32:00 +0530 Fowl Player Fowl Player The VH Group is committed to bring about positive improvements in the poultry industry. Venkateshwara Hatcheries Pvt Ltd (VHL) continued to lead the Indian poultry vaccine market with the market share of over 60 percent. The biologicals sales revenue of VHL crossed its targeted mark of Rs 250 crore for the year 2005-06 to reach Rs 280 crore. According to OP Singh, CEO, VHL, the figure includes sales of diagnostics, avian influenza vaccines,18 percent of exports, small amount of internal sales and sales of biological products from animal health products division. The animal health products division has products which include vitamin premixes, therapeutic products, growth promoters and dewormers for the poultry industry ensuring better health and enhancing performance in breeders as well as commercial layers and broilers. The VH Group regularly exports its products to SAARC countries, South Asia, Middle East, Japan, Europe, and Africa. VHL registered a three-digit growth in 2004-05 with sales of Rs 188 crore against previous year's sales of Rs 88 crore. This figure includes sales from vaccines, 15 percent exports, internal sales and AHP. However, industry reports say that the total animal biologicals market including the poultry is about Rs 250 crore and VHL is leading the poultry vaccines sector with market share of over 60 percent. To emerge as a multiple country operation in vaccines, VHL is now looking at establishing manufacturing facilities in South Africa and South East Asia. In this regard it is in discussion with many players but nothing concrete has emerged so far. Besides poultry vaccines business, VHL has also entered the human vaccines space and has set up separate division called BV Biologicals. The team at BV Biologicals is working on human vaccines for ailments that afflict a majority of the common populace. This unit at Hinjewadi Biotech Park near Pune is nearing completion, in which VHL has invested Rs 60 crore and another investment of Rs 120 crore will follow. Soon it is expected to launch its human biologicals products. VHL has also entered into a tie-up with a US-based company for biodiagnostics and biogeneric products. The aim of this tie-up is to bring in certain new molecules for diseases such as cancer. It is also investing in new vaccines and biotherapeutics for child and adult immunization. There are plans to enter the protein drug sector as well. VHL is also looking at taking a majority stake in state-owned Haffkine Bio-Pharmaceuticals and has already submitted proposal to the government of Maharashtra. But the government is yet take any decision on this matter. Ventri Biologicals, a vaccine division of the VH group, is a leader in poultry vaccines business in India. Started in 1980, the division produces vaccines for Marek's disease and Newcastles's disease. The plant was built in collaboration with Tri Bio Laboratories Inc. of USA, a world leader in vaccine technology and research. Its vaccine plant is acknowledged as one of the most modern plants and is capable of meeting the demands of the projected growth of the Indian poultry industry. Backed by extensive and modern research and development facilities, Ventri Biologicals is constantly engaged in developing new generation vaccines, to combat emerging bacterial and viral diseases. It produces vaccines conforming to British Pharmacopeia and other international standards. The division works in close association with PDRC, Poultry Diagnostic and Research Center that provides the technical service and carries out disease surveillance across the country. Ventri Biologicals provides a wide range of 32 poultry vaccines, some of which have been introduced for the first time. ]]> <![CDATA[Mahyco Monsanto Biotech]]> https://biospectrumindia.com/news/95/4867/mahyco-monsanto-biotech.html https://biospectrumindia.com/news/95/4867/mahyco-monsanto-biotech.html Thu, 15 Jun 2006 14:30:00 +0530 The Enlightener The Enlightener MMB is ready for the market pull. Mahyco Monsanto Biotech (India) Ltd (MMB), a 50:50 joint venture between Maharashtra Hybrid Seeds Corporation (Mahyco) and Monsanto India Ltd, reported a turnover of Rs 391.25 crore in 2005-06. It registered a growth of over 140 percent. All this comes as technology transfer fee from the companies that are taking Monsanto's Bollgard (genetically modified cotton) technology. This growth has been on account of increase in the demand for Bt cotton in India. Bt cotton in India was introduced in 2002. From 72,000 packets (with three approved Bollgard hybrids from Mahyco) sold in 2002, the market grew to 13 lakh packets in 2004 (with four hybrids) and to 31 lakh packets in 2005 (with 20 hybrids). In 2005, 20 hybrids of Bollgard including three approved hybrids of Ankur Seeds and two hybrids of Nuziveedu Seeds were planted across all nine cotton-growing states. Besides, the companies involved in large-scale field trials for bollgard hybrids have also multiplied. Despite the high seed cost, farmers are demanding Bt cotton seeds, thanks to MMB and its efforts to create the awareness amongst the farmers across rural India. MMB has launched "the Bollgard Kisan Vigyan Jyoti program" in April 2005 to enlighten the farmers. It roped in popular cine star Nana Patekar, to tour the Maharashtra countryside and spread the word about benefits of biotechnology, with the rural audiences. The number of players too is on the rise. The Genetic Engineering and Approval Committee (GEAC), which met in May 2006, granted regulatory clearance to 16 new Bollgard cotton hybrids for cultivation in north and central India. With this approval, the total number of Bollgard cotton hybrids has increased to 36 in the 2006-planting season. With this, the number of Bollgard hybrids available in the north and central zone has risen to 12 (from 6) and 22 (from 12) respectively. The approval was given to seven new seed companies-Ganga Kaveri Seeds, Ajeet Seeds, Tulasi Seeds, Vikram Seeds, Vikki's Agrotech, Emergent Genetics India, and Pravardhan Seeds. Maharashta Hybrid Seeds Co., Nuziveedu Seeds, Ankur Seeds and Rasi Seeds already have the licenses for developing the Bt cotton hybrids using Bollgard technology from MMB. IMRB International conducted a survey on the outcome of Bollgard technology. The survey reports that farmers have recognized the value of Bollgard, and that it has gained widespread acceptance in the nine states where it is being sold. In order to ensure this value is shared broadly, Monsanto's Bollgard technology has been licensed to 21 different Indian cottonseed companies who have incorporated the trait into their best hybrid seeds and also reduced the technology fees to the seed companies. MMB has also announced a 30 percent cut in the technology fee charged to seed companies for use of its insect-protected cotton technology from the current season. This has been reduced to Rs 900 per 450gm packet of Bollgard cottonseed. This will give MMB's seed company licensees an opportunity to pass along new savings to farmers if they choose. The government of Andhra Pradesh has approached the Monopolies and Restrictive Trade Practices Commission (MRTPC) in early January 2006 on pricing of Bt cottonseed by MMB and has been asking for compensation to the farmers from the seed company, Mahyco. The Supreme Court will hear an application on June 5, 2006 to stay the order recently issued by the Andhra Pradesh (AP) Agriculture Commissioner specifying a fixed price for Bt hybrid cottonseeds. ]]> <![CDATA[Biocon Ltd]]> https://biospectrumindia.com/news/95/1722/biocon-ltd.html https://biospectrumindia.com/news/95/1722/biocon-ltd.html Thu, 15 Jun 2006 14:27:00 +0530 Stunted Growth Stunted Growth Biocon Ltd's biotech business records 6.44 percent growth. Biocon has been the No. 1 company for the past three surveys. However, in this year's survey, Biocon loses its top position to Serum Institute of India by Rs 15 crore. Biocon reported a total sales of Rs 688 crore for the year ending March 2006 from the sale of biopharmaceuticals and enzymes. This figure does not include the business of its other arms Syngene International, Clinigene and Biocon Biopharmaceuticals. As a group, the company ended the year at Rs 793 crore. Biocon, an integrated biotechnology enterprise, reported a single digit growth in FY 2005-06. This has been challenging year due to pricing pressure on the statins market. The company's total sales from the biopharmaceuticals business was Rs 603 crore compared to the previous year's business of Rs 557 crore, up by 8 percent. Its enzymes business came down from Rs 90 crore in 2004-05 to Rs 85 crore in 2005-06. This was due to the capacity constraints it had because its new facilities were not up and this had, in a way, eaten into its enzymes capacity in order to deliver on its pharmaceutical products. But going forward, it expects to see better growth as a new biologics facility has been commissioned. Its new biologics facility in its 100-acre Biocon Park will manufacture a range of products encompassing monoclonal antibodies and other recombinant therapeutics. This facility, Biocon hopes, will put it in a strong position in the biomanufacturing and bioprocessing area. It aims to be a large-scale producer of antibodies and other cell culture products in India, and using all these capabilities, Biocon hopes to see itself as being an extremely attractive alliance partner for new molecule development. The company's focus has increased on innovation-led molecules as well as on biogenerics like insulin. A clear signal has been the acquisition of Nobex's technology platforms for $5 million. It intends to leverage this platform through co-development, outlicensing, and its own development. It entered into an MoU with the prestigious Karolinska Institute, Sweden to collaborate on joint research programs among other things. According to Kiran Mazumdar-Shaw, chairman and managing director, Biocon, the company is embarking on a very strong innovation discovery led pathway, which entails a lot of R&D investment. The R&D investment has gone up by 76 percent to Rs 76 crore. Newer segments like the insulin, branded formulations, and research services business have shown strong growth. These segments registered a 52 percent growth to touch Rs 100 crore from Rs 66 crore, the previous year. Oncology is another very important segment for Biocon. Its first molecule, the anti-EGFR antibody is expected to at least get into the Indian market in this fiscal. Biocon has a strategic partnership with Rochester-based biotechnology company Vaccinex Inc. for antibodies. Vaccinex's human antibody platform provides a strong IP protection for its discovery programs. Its Vaccinex and Nobex investments as of March 2006 were about Rs 52 crore. Its insulin, INSUGEN, launched in 2004, is being marketed in about 16 states across India with a strength of around 150 people. And it plans to double this strength by the end of this year, with the objective of making INSUGEN one of the top brands. It believes it has close to 10 percent share of the insulin business in the country. During the next fiscal, Biocon is hopeful of achieving healthy sales growth, despite the pricing pressure on its statins business. The company is on track in its efforts to transition itself from a generics to an innovation-led business. ]]> <![CDATA[A Good Year Again]]> https://biospectrumindia.com/news/95/8209/a-good-year-again.html https://biospectrumindia.com/news/95/8209/a-good-year-again.html Wed, 14 Jun 2006 16:59:00 +0530 A Good Year Again BioPharma sector alone crosses A Good Year Again BioPharma sector alone crosses $1 billion (Rs 1,046 crore) in revenues, but the industry falls short of the $1.5 billion mark by $50 million. Repeating the previous year's growth rates, India's biotechnology industry has notched up another good year in 2005-06 with sales growth of 37.42 percent to reach Rs 6,521 crore ($1.45 billion) in revenues. The industry narrowly missed the $1.5 billion mark by just $50 million (Rs 225 crore). All sectors witnessed growth Last year has followed another landmark year of 2004-05 when it crossed the $1 billion (Rs 4,745 crore) mark. What is remarkable is that the BioPharma sector, comprising vaccines, therapeutics and diagnostics has recorded $1.05 billion in revenues (Rs 4,708 crore). The sector recorded 31.88 percent growth. It was the single largest sector and accounted for 72.20 percent share of the Rs 6,520 crore biotech industry. BioAgri sector continued to be the fastest growing sector for the second year in a row. It posted 81 percent growth clocking Rs 598 crore in sales. However, the BioAgri sector remained the third largest contributor to the industry. BioAgri's share of the industry was 9.17 percent. BioServices with 11.03 percent share of the industry garnered Rs 719.5 crore in sales and registered 69.29 percent growth on the previous year's figure. BioIndustrial and Bioinformatics grew by 17.19 percent and 20 percent respectively to Rs 375 crore and Rs 120 crore in 2005-06. Exports soar The total biotech exports in 2005-06 were at Rs 3,357.17 crore, while the domestic business reported Rs 3,163.83 crore in sales. The exports accounted for 51.48 percent share of the total industry. BioPharma exports accounted for 74.33 percent of the total exports of Rs 3,357.17 crore, clocking Rs 2,495.24 crore in revenues. BioAgri's share of exports was the lowest at 1.07 percent and exports from this segment stood at Rs 35.88 crore. BioServices overseas revenues were Rs 684 crore. BioIndustrial and Bioinformatics sector accounted for 1.23 percent and 3 percent share of the total exports respectively. BioPharma again accounted for the largest share of the domestic business. Its business in India accrued to Rs 2,212.76 crore and accounted for 69.94 percent share of the total domestic market of Rs 3,163.83 crore. BioAgri was the next big contributor to the domestic biotech business. The revenues from this sector in India was Rs 562.12 crore. NOTE This year BioSpectrum-ABLE Survey is being reported in two issues-June 2006 and July 2006. While this issue focuses on the Top 20 Ranking and directory of biotech companies, the second issue (July 2006) will cover in detail the analysis of each of the major segments, human resource aspects, and BioSuppliers among other things. Serum Institute of India, the No. 1 biotech company Pune-based Serum Institute of India tops the industry rankings with total sales of Rs 703 crore, moving ahead of Biocon Ltd, which occupied the top slot in the previous three surveys. Biocon closed the year with total sales of Rs 688 crore from its biopharmaceutical and enzymes businesses. While Biocon registered 6.44 percent growth, Serum Institute of India grew by 39.21 percent in FY06. The Top 20 and Next 21-35 Companies Tables clearly point out that the industry is not only growing, but is also maturing as an all-inclusive industry. The Top 20 list includes BioAgri companies, BioPharma companies-both animal and human health as well as BioIndustrial companies. The Top three companies are primarily in the BioPharma sector and accounted for a total business of Rs 1,829 crore. Panacea Biotec is the third largest company with biotech revenues of Rs 437.82 crore. The fourth, fifth and eighth ranked companies are focused on the BioAgri segment. Mahyco Monsanto Biotech ranks fourth with Rs 391 crore, while Rasi Seeds is fifth with Rs 309 crore and Mahyco stands at Rs 117.76 crore. The three account for Rs 817.76 crore in revenues. The sixth and tenth places are occupied by companies primarily focused on animal health segment. Venkateshwara Hatcheries is ranked sixth at Rs 280 crore and Indian Immunologicals with Rs 102.67 crore in revenues is ranked tenth. These two account for Rs 382.67 crore. Further, it may be observed that the difference between MNC versus indigenous is thinning down. The MNCs are positioning themselves as local companies, home-grown companies. There are many MNCs too in the Top 20 ranks-Novo Nordisk and Aventis. This is a clear sign of the heterogeneous nature of the biotech businesses. Further the change in the rankings reflect that companies are doing businesses in sync with the industry trends. It has to be pointed out that the Top 20 Rankings do not include the diagnostics and bioservices companies, a conscious decision taken to evolve true list of biotech companies as is the global practice. Top 20 Home Grown Companies We have drawn a list of Top 20 Homegrown companies to track the progress being made by India-grown biotech companies. While the Top 20 companies of the "Top 20 Biotech" list have recorded total sales of Rs 4036.59, the "Top 20 Homegrown" companies registered total sales of Rs 3,419.57 crore. The Top 20 Biotech companies in 2005-06 accounted for close to 61.9 percent of the total biotech market of Rs 6,521 crore. Compared to that figure, the Homegrown companies contributed 48.45 percent of the total biotech business in 2005-06. The top five companies in the list of "Top Homegrown" companies and "Top 20 Biotech" are the same. The homegrown companies are maturing and consolidating their global positions too. For example, Serum is a global leader in MMR vaccines and Indian Immunologicals is one of the largest producers of Foot and Mouth Disease (FMD) vaccines. The next five in the homegrown list were Venkateshwara Hatcheries, Mahyco, Indian Immunologicals, Shantha Biotechnics and Bharat Serums. This list also reflects the diverse nature of the sector. The top five companies accounted for 38.79 percent of the total market of Rs 6,521 crore in both categories. While the Top 10 homegrown companies accounted for 46.47 percent of the market share, the Top 20 biotech companies in the country accounted for 50.9 percent of the total biotech business. Top Groups Biocon and Serum are the two largest biotech groups in the country. Biocon Group's total sales during 2005-06 were Rs 793 crore. It is an integrated biotechnology enterprise focused on biopharmaceuticals, enzymes, and research services. Biocon Group consists of Biocon Ltd, focused on biopharmaceuticals business, which includes statins and immunosuppressants, and enzymes, and it reported total sales of Rs 688 crore for the year ending March 2006 from these businesses. The Group's other companies include Syngene International, Clinigene and Biocon Biopharmaceuticals. Syngene and Clinigene are focused on custom research and clinical research respectively, while Biocon Biopharmaceuticals is focused on new molecule developments. The research services business of Biocon, mostly comprising that of Syngene, has grown by 52 percent to Rs 100 crore from Rs 66 crore and contributed to 13 percent of the group's operating revenues in FY 2006. Serum Group, on the other hand, has Serum Institute of India and Serum International as the two major companies. Serum Institute of India is the top biotech company in the country with record sales of Rs 703 crore in 2005-06, registering 39.21 percent growth. Serum Institute of India leads the industry with a range of vaccines-Rubella, BCG Vaccine, Measles, MMR and HepB. Serum International Ltd is its marketing arm to sell research-based products of Serono, Switzerland, and this recorded sales of Rs 39 crore compared to 2004-05 sales of Rs 60 crore. The reason for the drop is mainly because the management wants to now focus on launching its own indigenous products. Now Serum Group is also setting up Serum Bio Pharma Park at Pune, India's first biotech SEZ. The Park is located in Hadapsar, adjoining Serum Institute's existing manufacturing unit and it proposes to invest about Rs 1,200 crore to develop the park. The entire project will be completed in phases by 2010. New Page 1 New Page 1     ]]> <![CDATA[Niulab represents Precisa Instruments in India]]> https://biospectrumindia.com/news/95/2028/niulab-represents-precisa-instruments-in-india.html https://biospectrumindia.com/news/95/2028/niulab-represents-precisa-instruments-in-india.html Fri, 12 May 2006 12:01:00 +0530 Niulab represents Precisa Instruments in India Niulab represents Precisa Instruments in India Niulab Equipment, a supplier of analytical and laboratory equipment to life sciences and biotechnology companies, has joined hands with a Swiss company Precisa Instruments AG. "Niulab is proud to be associated with some of the worlds' most innovative, and technologically sound manufacturers of analytical instruments used in the pharmaceutical, biotechnology, food and petrochemical industry. Each manufacturer is a proven leader in our industry. They have been carefully selected to partner with Niulab to provide a complete solution to our customers looking for analytical instruments requirements for their laboratory for the compliance of FDA or other governmental regulations," said Ashok Kotwani, founder of Niulab Equipment. Established in 1982, the company provides the tools necessary to help with the quality control and research in various fields. Niulab Equipment is the authorized sales and service distributor for a many international instrument manufacturers including Thermo Optics, Thermo Electron Corporation for their chromatography, mass spectroscopy and liquid elemental range of products, Bruker GmbH, Germany, CEM Corporation, USA, LI-COR Biosciences, USA, Veolia Water (ELGA Lab Water), UK, Tekmar Dohrmann, USA, New Brunswick Scientific,UK, Protein Technologies, USA, Eltra GmbH, Germany, Netzsch GmbH, Germany and Petrotest GmbH, Germany.   Invensys launches new enterprise control system Invensys Process Systems, a global player in the industrial asset performance management, has announced the launch of world's first enterprise control system called InFusion. The new InFusion enterprise control system combines industry capabilities from across Invensys with advanced enterprise information and integration technologies from both Microsoft and SAP to dramatically reduce integration costs. Speaking to mediapersons in Mumbai, Chris Lyden, corporate marketing, vice president, Invensys Process Systems said, "With InFusion technology, the most existing plant floor and enterprise systems can now be cost-effectively integrated into a common system. In conjunction with a suite of new performance services, the InFusion system will help industrial enterprises more effectively align plant operations and maintenance departments with the business to optimize overall asset performance management."   Shimadzu opens customer center in India Shimadzu Analytical (India), a wholly owned subsidiary of Shimadzu Corporation, Japan has opened its customer support center equipped with the state-of-art instruments. The center will focus on customer training and aid in analytical method development for its customers. Speaking to mediapersons, Shigenori Nada, managing director, Shimadzu Analytical (India) said, "We are investing about Rs 4 crore (100 million Yen) in setting up the company in India. With staff strength of 20 personnel at the initial stage, we will increase it to 40 within a year's time. In addition to overseeing the activities of the customer support center, we will also provide the marketing support to our distributors." Sharing the details about the Indian operation, he said, "We are also setting up a software development center to meet the Corporation's software needs. The center will also act as a support hub to the South Asia region. We are looking at achieving a target of Rs 300-400 crore in the next five years."   Nicholas Piramal implements LabVantage's Sapphire LIMS Nicholas Piramal India Ltd (NPIL) has announced the implementation of LabVantage's Sapphire TM, laboratory information management solution (LIMS) at the Nicholas Piramal Research Center (NPRC) in Goregaon, India. Harish Chawla, CIO, NPIL said, "We selected LabVantage's Sapphire after evaluating many Indian and international LIMS packages and visiting a number of installations." Anil Kastuar, president of LabVantage's operations in the Asia-Pacific said, "LabVantage has successfully implemented Sapphire at NPRC in just six months. With our in-depth domain knowledge of pharmaceutical R&D and quality processes, and the insight of the regulatory provisions including 21 CFR Part 11 and GxP standards, we offered NPRC an exceptional solution with measurable gains."   Proteomics International ties up with TechnoConcept Australia-based Proteomics International has concluded a deal with New Delhi, India-based TechnoConcept, whereby the Indian company would become the exclusive supplier of Proteomics' cutting-edge protein analysis services. Dr Richard Lipscombe, MD, Proteomics stated that the deal would increase the capabilities of both the Western Australian Institute for Medical Research (WAIMR) and Proteomics, as well as adding to the overall capacity of the state to deliver biotechnology-related services.   RSA Security to open development centre in Bangalore RSA Security, a global player in protecting online identities and digital assets, announced its plans to open its first development centre in Bangalore. The centre will operate in tandem with RSA Security's other development centres located in Brisbane, Australia; Bedford, USA; Herzelia, Israel; and Chennai, India, at HCL Technologies, Inc. Outlining the plans for the development centre, Stan Swiniarski, vice president of Engineering (identity and access management) at RSA Security, said, "The Bangalore development centre will oversee the company's award-winning identity and access management software products and will also play a key role in building mission-critical consumer solutions for authentication and extending our current fraud protection offerings." ]]> <![CDATA[Biocon's new biologics facility inaugurated]]> https://biospectrumindia.com/news/95/5325/biocons-new-biologics-facility-inaugurated.html https://biospectrumindia.com/news/95/5325/biocons-new-biologics-facility-inaugurated.html Fri, 12 May 2006 11:57:00 +0530 Biocon Biocon's new biologics facility inaugurated Finance minister, P Chidambaram recently inaugurated Biocon Biopharmaceuticals, claimed to be India's largest multi-product biologics facility at Biocon Park, Bommasandra Industrial Area - Phase IV. Biocon established Biocon Biopharmaceuticals Private Limited (BBPL) in collaboration with CIMAB, representing the Centre of Molecular Immunology, Cuba. The state-of-the-art cGMP compliant facility is designed to manufacture a broad range of novel and bio-similar therapeutic products through large scale cell-culture fermentation for the treatment of cancer, auto-immune and metabolic diseases. Kiran Mazumdar-Shaw, chairman and managing director, Biocon, said, "The facility is also designed to cater to contract manufacturing needs of international biopharmaceutical companies. Biocon's multi-disciplinary technological capabilities and growing expertise in clinical development has enabled rapid advances in the field of protein therapeutics. Biocon believes that such novel products of biotechnology will provide quantum growth drivers for the future." The l,20,000 sft building spread over three floors comprises process, laboratory and technical support areas. The new facility represents a significant advancement in terms of technical sophistication over Biocon's existing facilities and comprises three distinct modules - cell culture module for monoclonal antibodies and other cell culture products; aseptic formulation and filling module for sterile products in vials, cartridges, lyophils and syringes; and quality control module. Dr Arun Chandavarkar, president, operations, said, "The new facility is benchmarked to the highest regulatory standards and will position Biocon and Biocon BioPharmaceuticals as a key global player in the field of cell culture fermentation technology. The plant is designed with an in-built 4-fold expansion capacity keeping in mind Biocon Biopharmaceuticals' research pipeline and global market trends. This new facility will provide immediate job opportunities to over a hundred scientific and technical personnel." IMRB survey reconfirms benefits of Bt cotton As against the general notion about the failure of the cotton crop, IMRB International (a part of the WPP's Kantar Group of Companies) with over three decades of market research experience in India has found that farmers who planted Bollgard cotton earned an additional Rs 2,100 crore in income based on 3.125 million acreage penetration for the 2005 crop. According to Nikhil Rawal, senior vice president and executive director, IMRB International, "This second IMRB survey of Bollgard has reconfirmed for us the earlier findings that farmers stand to benefit from the usage of this technology. A total of 31 districts were covered as part of the research out of the 80 cotton districts across cotton growing states in India. Better yields and less pesticide usage have been the key triggers for farmers choosing Bollgard over conventional cotton." The IMRB International survey estimated that there has been a 64 percent or 4.16 quintals per acre increase in Bollgard yields when compared with conventional cotton. The net profit increase for farmers using Bollgard is Rs 6,727 per acre or over 118 percent. It also observed that there is a reduction of an average 2.4 pesticide sprays against bollworm that translates to a 25 percent reduction in total pesticides spend. IMRB International interviewed 4799 farmers across 31 cotton-growing districts in Punjab, Haryana, Rajasthan, Andhra Pradesh, Karnataka, Tamil Nadu, Madhya Pradesh, Maharashtra and Gujarat. This survey reconfirms that for the fourth successive year, the benefits of Bollgard cotton to Indian farmers included better yields, reduced pesticide use and higher profits. ICRI partners with Cranfield University To drive an international perspective to clinical research education in India and to deliver on India's growing demand for skilled clinical research professionals, Mumbai-based Institute of Clinical Research (India) has entered into an academic alliance with Europe's research led institution, Cranfield University, the UK. This alliance would further the cause of ICRI in India in grooming professionals in clinical research to face exciting challenges posed by the pharmaceutical sector and also pave the way for new career opportunities in this field. An agreement to this effect was signed between the two collaborating organizations in the presence of Vicky Treadell, the deputy high commissioner, British High Commission. Commenting on the alliance, Dr SK Gupta, dean, Institute of Clinical Research (India) said, "The association with Cranfield University would help the ICRI to impart innovative education through an international exchange of knowledge dissemination in clinical research, which would further help deliver on the growing demand for highly skilled clinical research professionals in India." Speaking on the occasion, Prof. Clifford Friend, deputy vice chancellor, Cranfield University said, "This alliance gives us an opportunity to address the growing demand for clinical research professionals in India. The perfect combination of ICRI's networking with the Indian pharmaceutical sector and their current course orientation and Cranfield University's distinctive competences in biomedical sciences and clinical research data studies bring immense potential to furthering the cause of clinical research in India." Cranfield University would undertake responsibility for the quality academic orientation in clinical research and training methodologies, evaluative studies, project assessment, knowledge exchange and final certification of Cranfield-ICRI's two-year full time Masters program in clinical research. Shasun to launch its first rDNA product in 2007 Recognising the role of biopharmaceuticals in the future of global pharmaceutical industry in enhancing therapeutic effectiveness, improving lifestyle quality and strengthening corporate profitability, Chennai-based Shasun Chemicals and Drugs Ltd, a premier service provider to the pharmaceutical industry has been engaged in developing technologies for recombinant biogenerics using the microbial expression platform. And it will launch its first biotech product r-Streptokinase in 2007. Speaking to mediapersons in Mumbai, Govindarajan, CEO, Shasun Chemicals and Drugs Ltd said, "One of our product under development has successfully cleared animal toxicity studies and is under clinical testing. Meanwhile, we have developed capabilities in the area of biotechnology services like upstream and downstream processing, analytical and quality assurance. And the cGMP production facility for biopharmaceutical proteins is nearing completion. We are looking for tie-ups with suitable co-marketing partners to launch these products in the Indian market.?h Shasun offers services in research, development and manufacturing (including Contract Research and Manufacturing Services- CRAMS) and set up its biotech R&D facility in 2002. Currently it has a team of 22 scientists. It is also looking for tech transfer and discussions are on with a couple of companies for the same, Govindarajan said. Shasun reported a significant growth in the business of CRAMS as its revenue grew to Rs 38 crore in 2005-06 from Rs 24.5 crore (2004-05). The company recently acquired the pharmaceutical custom synthesis business of the Rhodia Group, the UK and is targeting to close FY07 with a Rs 750â€“800 crore and FY08 with Rs 1000 crore. Indian groups oppose patenting of AIDS drug The Indian Network of People Living with HIV/AIDS (INP+), the Manipur Network of Positive People (MNP+), represented by the Lawyers' Collective HIV/AIDS Unit officially submitted their opposition to a patent application filed in the Kolkata patent office by GlaxoSmithKline (GSK) for Combivir, a fixed-dose combination of two essential AIDS drugs zidovudine/lamivudine. The opposition is based on technical and health grounds. "We are objecting to the patenting of Combivir because it is not a new invention but simply the combination of two existing drugs. More importantly, the granting of such a patent risks increasing the cost of anti-retroviral treatment for many people living with HIV/AIDS, thereby further increasing the burden on developing countries already struggling to treat patients," said KK Abraham, president of INP+. Combivir is a widely used fixed dose combination and is used extensively in projects run by international aid organization Medecins Sans Frontieres (MSF). Almost all the Combivir used by MSF is generic. India, Burkina Faso, Mongolia, Central African Republic, Malawi, Peru, the Republic of Kyrgizstan, Cambodia, Ukraine and Swaziland are other countries also identified by the Global Fund as using generic Combivir, the release said. Mascon files its first patent in bioinformatics Mascon Life Sciences has filed its first patent, which is also probably India's first patent as well, in the bioinformatics arena. This invention is in the field of theoretical biology. Here the DNA is converted into a unique signal, which is further processed in order to extract the needed biological features. The authors for the invention are Vivek Kumar Singh, Vivek Gangadhar Mahale and Dr Avinash Purusottam Agnihotry. "This patent is in the basic sciences area and is going to revolutionize the entire bioinformatics research", commented Vivek Mahale. "We have developed different mathematical models and functions for different biological features. The theory of decoding the DNA sequence into a unique signal is of very basic in nature and has produced remarkable results when applied to extract the features from a genome", said the Vivek duo. According to Vivek Singh, "This work is in true essence the genius of mathematics applied to biology". He further added, "We have efficiently tackled problems like gene finding, promoter prediction, splice site detection, alternate splicing codon degeneracy and phylogenetic cluster analysis. The proposed algorithm was found far more efficient and accurate than even presently available ab-initio methods for coding region identification." "This is a fantastic job. This is the very first patent we have ever acquired as a group and a great accomplishment", said Gowri R Shanker, director, operations, Mascon Global Ltd. The patent has been filed as Indian Patent vide Patent Application No. 953/DEL/2005, and the US patent has been applied for. The patent is titled "Method for conversion of DNA sequence to a number string and application therefore in accelerated drug design". Panacea Biotec opens pharmaceutical formulation plant at Baddi Panacea Biotec has commenced production in its new pharmaceutical formulation plant at Baddi, Himachal Pradesh with an investment of around Rs 45 crore. This plant is in compliance with global standards including US FDA and UK MHRA, SA MCC and WHO cGMP. Situated amidst picturesque surroundings in the state of Himachal Pradesh, Panacea Biotec's facility in Baddi is spread over 70,000 sm and will cater to the manufacturing of oral and topical pharmaceutical finished dosage forms. The facility is equipped with modern equipment and machinery to meet the regulatory standards of the US, European and South African markets. The Baddi facility with high capacities and scope for future expansion is designed to produce various formulations viz. tablets, capsules, ointments and liquids. The facility has an installed capacity of 900 million tablets, 120 million capsules, 12 million ointment/gel tubes and 1.2 million litres liquid orals per annum. Inaugurating the plant, Rajesh Jain, joint managing director, said, "Our Baddi facility is a showcase of the latest in modern technology and is equipped with ultra modern and sophisticated machines and integrated packaging lines. The plant will produce high quality healthcare products accessible and affordable for all. This facility will give a competitive edge to the company as we continue to innovate and step up our growth strategy. This new manufacturing facility will support our future growth and facilitate rapid rollout of new products". ]]> <![CDATA[New Regulatory Era]]> https://biospectrumindia.com/news/95/2829/new-regulatory-era.html https://biospectrumindia.com/news/95/2829/new-regulatory-era.html Fri, 12 May 2006 11:55:00 +0530 New Regulatory Era New Regulatory Era The announcement of the implementation of most of the key recommendations of the Mashelkar Task Force on recombinant pharma products is good news. The exemption of LMOs from the purview of GEAC approval itself will take nearly 90 percent of the forthcoming biopharma products from the purview of the laborious regulatory approval process. S&T Minister Kapil Sibal and DBT Secretary MK Bhan have used almost every public platform to reiterate that the government was working on other suggestions to set up a single-window regulatory structure. Their immense commitment to the biotech sector and the path-breaking changes introduced in the past 20 months gives the industry the hope that they will deliver on the promises at the earliest. In the meanwhile, India also had another success with the biotech leaders at the BIO meeting in Chicago in early April. Sibal was in the forefront of selling the Indian story and he made big pitch to the global leaders to consider India as a destination to move the drug development process to make the new drugs affordable to more people around the world, leveraging the lower developmental costs. The biotechnology industry celebrated its 30th anniversary. The modern biotech industry traces its origin to the founding of Genentech, now a $6.2-billion giant, in April 1976. The BIO convention started in a small way in 1991 and has emerged as the world's most preferred biotech meeting with over 19,000 participants at the 14th edition in Chicago from 62 countries. The trade show has become really big almost all the major companies and most of the states in the US and European countries using the platform to attract biotech entrepreneurs. Asian countries have managed to attract attention in the last few with single pavilion which are getting bigger and bigger with each passing year under the country banner. Japan, China, Australia, Korea, Singapore, Taiwan and Malaysia have managed to get good attention using this route. India has been doing this for the past few year. But unfortunately, Indian efforts were scattered under two banners-CII and ABLE- and two other major companies participating separately. The $1 billion and growing industry is still small by global standards and the time has come for industry leaders to present a united front to the world at BIO. Industry leaders are unanimous that DBT should take up the leadership on this front too at least for the next edition of BIO scheduled for May 2007 in Boston and facilitate participation of India's most promising biotech companies under the country's banner. Collective resources of the country should be used intelligently and smartly, like our other Asian neighbors. While India and China continues to attract the attention of global policy makers and industry leaders in the life sciences sector, the industry is looking at the big picture for the next decade. Clearly, two new segments are emerging as the next big things in biotechnology: Biofuels and industrial biotechnology. Recent breakthroughs in enzyme technology have dramatically increased the yield and reduced the production cost of ethanol from agricultural waste. US President George Bush was quick to grasp the importance of this to lower America's dependence on imported petroleum products and shift to biofuels. Major policy changes have been made to boost the country's energy independence and now almost every influential American leader, including former President Bill Clinton, has become a champion of biofuels. Industrial biotechnology is the beneficiary of the advances in enzyme technologies and is in fact being referred to as the biotech industry's third wave. India has some headstart in these two emerging areas and we should build on these strengths and grab the emerging opportunities. ]]> <![CDATA[Information Management Technology]]> https://biospectrumindia.com/news/95/1835/information-management-technology.html https://biospectrumindia.com/news/95/1835/information-management-technology.html Fri, 12 May 2006 11:53:00 +0530 Information Management Technology Information Management Technology Laboratory informatics has a much broader application area-scientific research from drug discovery to production. Information science or "informatics" is the science of information. It is often studied as a branch of computer science and information technology and is related to database, ontology and software engineering. Informatics is primarily concerned with: Creating and structuring data Management, storage and retrieval of data Distribution and transfer of information Informatics is about the transformation of information by computation or communication; by machines or people. It is the intersection of artificial intelligence, cognitive science, computing science and related fields. Informatics focuses on understanding business or scientific research challenges and applying information technology as the solution-tackling the problem first rather than technology first. It combines software applications, search technology, database storage and tools for digitally-enabled collaboration. Laboratory informatics Laboratory informatics is the specialized application of information technology to maximize laboratory operations, particularly in analytical, production and research and development. Laboratory informatics encompasses data acquisition, data processing, data analysis and long-term archiving, electronic laboratory notebooks, laboratory information management, laboratory automation, scientific data management, document authorship, review and approval. What are common areas of informatics? Bioinformatics-Informatics in biology, especially genomics Cheminformatics-Informatics in chemistry and drug discovery Ecoinformatics-Informatics in ecology and environmental science Legal informatics-Informatics in the legal field Library and information science-Informatics in libraries Medical informatics-Informatics in medicine and healthcare Knowledge management-Informatics and knowledge Laboratory informatics-Informatics in the laboratory environment Is there a difference between bioinformatics, cheminformatics and laboratory informatics? Bioinformatics and cheminformatics are terms that describe specific areas of information management. While bioinformatics refers to the use of computing methods to create, organize, retrieve and analyze databases of biological information, such as the nucleic acid sequence data contained within a genomic database. Cheminformatics focuses on the collection, storage and analysis of chemical structures and syntheses, pharmacological studies and combinatorial chemistry to facilitate drug discovery and development. These areas of informatics are called vertical informatics domains since they deal just with a subset of applications. Laboratory informatics has a much broader application area; it touches all areas of scientific research from drug discovery to production. Therefore it is called a horizontal domain. Horizontal informatics solutions A horizontal informatics solution provides more benefits to an organization, because it addresses broad-scale issues such as compliance, data archiving, collaboration and sharing information, and capturing knowledge. Horizontal applications are generic by nature. Laboratory informatics solutions can be implemented in a lab, in a department or throughout an enterprise-as well as in the vertical domains of bioinformatics, cheminformatics or other scientific environments. Companies derive the most value from intellectual property rather than physical assets. To derive the most value from a company's intellectual assets, knowledge must be shared among a company's strategic decision-makers, though leaders, scientists, and other research team members, serving as the foundation for collaboration. There is no universal definition of knowledge management (KM). A simple definition: knowledge management is the process through which organizations generate value from their intellectual and knowledge-based assets. Generating value from such assets involves sharing them among employees, departments and even with other companies in an effort to devise best practices. But what constitutes intellectual or knowledge-based assets? There are two categories, explicit (tangible) and tacit (intangible). The examples of explicit knowledge include patents, raw data, reports, results, pictures, drawings, publications, and ideas. The explicit knowledge consists of anything that can be documented, archived, and codified. Tacit knowledge- or know-how-is contained in people's heads. The challenge inherent in tacit knowledge is figuring out how to recognize, generate, share and manage it. Even simply identifying tacit knowledge is a major hurdle for most organizations. How can laboratory informatics help to manage knowledge in labs? Each laboratory has basic needs it must manage such as furniture, supplies, waters, gas, power and glassware. Scientists can easily identify these requirements if you ask them, but what about information? Do they have to sift through numerous paper archives, databases and applications to find information? Are you they able to work in a consistent application environment? Are they concerned about the company's ability to manage data compliance and intellectual property on a global scale? All laboratories share a basic need to capture both explicit and tacit knowledge. And there are solutions available like for instance Waters offers powerful solutions for capturing and managing both explicit and tacit knowledge through Waters NuGenesis Scientific Data Management System (SDMS), eLab Notebook Software. Extract from "A Guide to Information Management Technology" of Waters Laboratory Informatics.   ]]> <![CDATA[HP's supercomputer will greatly aid research at IGIB]]> https://biospectrumindia.com/news/95/1757/hps-supercomputer-will-greatly-aid-research-at-igib.html https://biospectrumindia.com/news/95/1757/hps-supercomputer-will-greatly-aid-research-at-igib.html Fri, 12 May 2006 11:51:00 +0530 HP HP's supercomputer will greatly aid research at IGIB "HP's Cluster Platform provides a scalable architecture that allows us to complete large simulation experiments such as molecular interactions and dynamics of protein folding much more quickly. This technology combined with HP's experience and expertise in life sciences helps IGIB speedy access to information, knowledge and new levels of efficiency." Dr Samir Brahmachari, director, IGIB The facility at IGIB has put India in the Top 500 global computational list Life sciences companies and those institutions involved at the cutting-edge of life science research face fierce competition and rising R&D costs as they work amidst various challenges to bring a breakthrough drug to market. Technology, especially in Informatics and Computational Sciences has an important role to play in helping further research in life sciences. The IT infrastructure must align with constantly changing business and research requirements. Many companies are implementing low-cost, high-technology IT infrastructures that can integrate with current environments, adapt quickly, and accelerate business and research processes with minimal or no disruption to operations. Life science research advances beyond the area of genomics is the next great challenge. This deals with life systems delving in genes to proteins, biotechnology to pharmaceuticals and to personalized medicine. The computational demands increase exponentially, necessitated by identifying and understanding all proteins and how their complexes in living beings interact with drug molecules. To meet these challenges, the Institute of Genomics and Integrative Biology (IGIB) was looking to acquire the computational power for research in complex molecular dynamics simulations, protein structure, interaction experiments and in-silico toxicity studies. Mapping complex requirements To realize these huge, complex computational challenges with very large data sizes will lead to the generation of complete physiological simulations that integrative system biology experiments will demand, necessitating the setting up of ultra scalable systems that reach to 4Teraflops and beyond. The IGIB has taken its first step with its 4+ TFlops supercomputer joining the world's leading supercomputing centers adopting life science supercomputing solutions. The IGIB 4 TFlops facility is built from open standard systems and platforms that deliver top efficiency. This allows the IGIB to quickly develop complex bioinformatics algorithms on the platform that facilitates easy sharing, painless adoption and joint collaboration with the best tier institutions around the world. The new Hewlett-Packard supercomputer will be used to meet the increasingly complex needs of life sciences research that has advanced beyond genomics. "HP's Cluster Platform provides a scalable architecture that allows us to complete large simulation experiments such as molecular interactions and dynamics of protein folding much more quickly," says Dr Samir Brahmachari, director, IGIB. "This technology combined with HP's experience and expertise in life sciences helps IGIB speedy access to information, knowledge and new levels of efficiency, which we hope will ultimately culminate in the discovery of new drug targets and predictive medicine for complex disorders. Using the HP supercomputer, in a short time we have been able to scan entire viral genome database to discover human miRNAs that can target crucial genes in HIV-1 and H5N1 bird flu influenza virus. The IGIB High Performance Computing Facility (HPC) is a 288-node Cluster Platform 3000 based on Intel Xeon HP ProLiant servers running the Linux operating system. The high-speed InfiniBand 10Gbps cluster interconnect is used and HP's XC System Software provides cluster management capability. In addition, this center will also have a 24-node, high-performance HP ProLiant cluster running Linux, a powerful HP Itanium based server that will be used for experimental projects by the students/developer community. The systems are supported by 12 Terabytes of HP StorageWorks Enterprise Virtual Array 5000 (EVA5000) storage and a MSL6060 tape library. The facility will also host a powerful scalable Integrity Superdome, an SMP server and 12 Terabyte storage capacity. To help customers manage and visualise the large volumes of data created by computational analysis, HP's Unified Cluster Portfolio, which includes entry-level HP Integrity and ProLiant servers and an enhanced HP StorageWorks Scalable File Share, provide a common implementation across Linux and servers based on industry-standard processors (Intel Xeon , Itanium 2 and AMD Opteron). Furthering the cause of medical issues "Partnering with HP will help to further advancements in research and speed progress in the discovery of new drug target and predictive medicines for complex disorders", adds Dr Brahmachari. "This will enable us to attract the best young minds of the country through attractive fellowships and world-class supercomputing environment. This partnership will ensure that the hassle of such a large and complex computing environment will be managed by professionals from HP." HP's most powerful supercomputer in Asia will be based out of IGIB's new facility and will be a national facility available to all researchers, scientists, companies and other organizations who need high end computational systems to address and contribute to help find solutions to critical medical issues. HP, under the partnership, will facilitate the investigation of collaborative research projects with its partners, institutions, other COEs and scientific communities (e.g. EPFL, SIB and Partners) in bioscience research. Ensuring maximum value creation This supercomputing facility at IGIB has put India in the Top 500 global computational list and as a leading center globally in the life sciences domain, while fostering excellence for research in life sciences. This infrastructure has helped IGIB join the Top 500 club, the HP Supercomputer being one of only a handful in India to make the list. Due to the seamless integration of IT into business operations, early identification of promising compounds will be possible, leading to a faster time-to-market and giving a higher return on investment. Large simulation experiments such as molecular interactions/dynamics, protein folding, virtual drug screening, discovering RNA therapeutics, etc. will be completed with faster turnaround times. This will not only accelerate discovery of new drugs and targets with minimum side effects but also enable solving fundamental problems of gene regulatory network and host pathogen specificity. Computational life science algorithms need both capability and capacity computational models. These involve multiple tasks that may demand simultaneous throughput. The IGIB can use intelligent resource management, provided as inbuilt in to the HP supercomputing cluster. The IGIB parallel algorithms require a highly scalable SMP server like HP's Integity Superdome SMP server. These highly scalable, parallelized applications pose the ultimate test to inherent scalability and parallel efficiency of a well- tuned HPC cluster. With HPC, IGIB can now accelerate the pace of innovation while driving greater cost savings, productivity and responding quickly to new opportunities and change, with complete, supported, highly scalable cluster solutions. Further, HP's leadership position in health systems innovation will help life sciences researchers and product developers at IGIB to speedily access new discoveries and aid in developing new therapeutics.   ]]> <![CDATA[Life Sciences IT Spend on the Rise]]> https://biospectrumindia.com/news/95/2872/life-sciences-it-spend-on-the-rise.html https://biospectrumindia.com/news/95/2872/life-sciences-it-spend-on-the-rise.html Fri, 12 May 2006 11:38:00 +0530 Life Sciences IT Spend on the Rise Life Sciences IT Spend on the Rise Life sciences companies today have realized the importance of Information Technology (IT) in their organization to increase productivity and optimize costs. The pharmaceutical market place today is marked by fierce competition. New products are being launched frequently and face shorter periods of market exclusivity. These need to be supported by well-coordinated organizational efforts. Significant "time-to-market" pressures faced by the pharmaceutical companies, coupled with regulatory compliance needs, have made the life sciences companies to adopt extensive enterprise-wide collaboration for discovering, developing and introducing new products into the market. These are some of the reasons for the life sciences companies in India to adopt technology to sustain growth and competition pressures. This cuts across the industry-be it the CROs or the product companies. iGATE Clinical Research International, a company focused on clinical research, for example, has been investing on IT and IT-enabled services to boost its process efficiency and productivity. Dr Vasudeo Ginde, founder and managing director, iGATE Clinical Research International, observed, "Started in 1997, we today have combinations of processes, software and other systems and solutions like ERP, CRF, MIS for labs, clinical data management, biostatistics, training, and project management tailor-made for clinical research and our needs." Looking at the emerging growth of business opportunities in clinical research, Ginde said that there must be a common platform for easy access of metrics and information from across the company i.e., bottom-to-top. The information includes operations, quality metric, costs, timelines, quality improvement, MIS, supply chain, inventory management, document management etc. Integration of this information has become the need of the hour. "We today have combinations of processes, software and other systems and solutions like ERP, CRF and MIS for labs." Dr Vasudeo Ginde, founder and managing director, iGATE Clinical Research International. "As the company is growing in size, getting into new business areas and spreading its footprints across the globe, IT becomes more of a necessity to integrate all functions of the company through a common platform and the need to communicate at a greater efficiency, with greater accuracy becomes indispensable." Hari Bhartia, co-chairman and managing director, Jubilant Organosys. "We plan to implement business intelligence and statistical analysis tools and looking at IT infrastructure enhancement and project management solutions." Rajesh Jain, joint managing director, Panacea Biotec. "We use discrete independent systems for our various needs." Dr Hemanth Nandigala, director, Virchow Biotech (P) Ltd. "The IT systems form the base for decision support system and improving the process efficiency at Indian Immunologicals." M Prabhakar Rao, GM-commercial, Indian Immunologicals. In fact, 18 months ago, iGATE Clinical Research International started developing a system called 360-degree Super Script under which every functional head in the company can access all kinds of relevant information at his fingertips. The reason: in the clinical research sector most of the sponsors are from the US or Europe. And there must be comprehensive tools that help the customer to access the information. "Now we have a system in place through which our customers can access this information on a real time basis. This helps the customers know the ground realities. We have started this with one client as a pilot project. With the success of this pilot project, we will extend this to other customers too," informed Ginde. According to Dr Hemanth Nandigala, director, Virchow Biotech (P) Ltd, several IT solutions are being used these days. For example, "For regular accounting, we use an accounting package. This is the same one that helps us align our systems and processes with that of our group concerns. For our R&D, we use a LIMS package-Biotracker from Ocimum Biosolutions. This not only helps us share information across the organization but also helps our managers to monitor the progress and make informed decisions. For our sales and distribution network, we use a billing and tracking software that is installed at remote locations across India. Regular IT needs like e-mail and website hosting are currently being handled by an independent third party. So we use discrete independent systems for our various needs," said Dr Nandigala. Take the case of Indian Immunologicals, a leading vaccines manufacturer. In its endeavor to provide affordable immunity, Indian Immunologicals constantly pursues measures that improve the efficiency and quality of its products. "IT is one such tool, which we use effectively to improve the process efficiency. We have started our IT initiatives about a decade ago and we have taken the benefits of the best technology available during that time. We have seamlessly integrated information systems, which give us online information pertaining to all the commercial activities. All our IT systems are designed with a premise to capture the data at the source either by way of software or data acquisition systems. Thus, by capturing the data at source, automating the process, and providing the necessary information, the IT systems form the base for decision support system and improving the process efficiency at Indian Immunologicals," informed M Prabhakar Rao, general manager-commercial, who also heads IT deployments. With companies today focusing on global presence, IT deployment is becoming a vital phenomenon. Look at Jubilant Organosys. "As the company is growing in size, getting into new business areas and spreading its footprints across the globe, IT becomes more of a necessity to integrate all functions of the company through a common platform and the need to communicate at a greater efficiency, with greater accuracy becomes indispensable," said Hari Bhartia, co-chairman and managing director, Jubilant Organosys. Jubilant Organosys, as a part of the information technology initiative, has introduced BaaN, an ERP (Enterprise Resource Planning) system, which enables it to plan online across the globe. "Forecasting forms a vital part of planning and BaaN enables us to forecast to a greater and better extent through availability of all the information on a click of button. For example, this system enables us to get a product wise costing sheets, so when the prices of raw materials increase or decrease we automatically come to know our cost of production and accordingly price our products," added Bhartia. It has also introduced tools such as Internal Control Mapping, which helps in process efficiency. With this all manually handled functions are getting transformed into IT driven applications and Jubilant is moving towards an automated and much more flawless and error free working atmosphere. Rajesh Jain, joint managing director, Panacea Biotec, felt the same. The company is increasingly using IT for its integration strategies relating to people, business processes and technology to gain operational excellence and competitive advantage. "Today regulatory compliance is an integrated part of the business process. We focus on scalability and flexibility of systems to support our growing business needs. We are exploiting the strategic opportunities created by bioinformatics," said Jain. The company's IT expenditure has a positive correlation and alignment with the organization's vision and priorities. Its expenditure for IT projects was around 1 percent of the net sales in 2005-06. Panacea has invested intensively in some of these areas. Infrastructure and connectivity: All its locations and sales depots are connected through VPN/VSAT, which is getting extended to the new locations. Enterprise Resource Planning: SAP ALL-IN _ONE solution for pharmaceutical vertical has been implemented. SAP's HRMS implementation is starting in near future. Communication and collaboration: Company is upgrading its communication and collaboration capabilities by implementing standardized "Microsoft Exchange and Share Point Portal Solution" throughout the organization. Clinical Trial: Oracle Clinical Trial is already being implemented. R&D: Laboratory Information Management System and research tools are at various stages of implementation and up gradation. And it plans to increase it technology expenditure further. "We plan to implement business intelligence and statistical analysis tools like BIW and SAS for statistical analysis. We are also looking at IT infrastructure enhancement and project management solution," said Jain. Certain aspects of IT implementation in a big pharma are more or less similar to the applications in any other vertical. Where as, certain aspects are compounded as the Pharma and healthcare industry has the added responsibility towards the health of people. IT plays a major role in ensuring that the Standard Operating Practices (SOPs) and policies are in place and is being adhered to-like the GXP (GMP, GCP, GPP, GLP) standards. From a compliance perspective, it helps in having proper application processes, controls and ensuring that the processes are being followed. According to the IT head of a leading global pharma company in India, "The role of IT can be divided into four parts in a clinical trial. First is the complete planning of a trial as the trials are carried on multiple sites and many a times in different countries simultaneously. Then comes the actual execution of a trial followed by data capturing and processing. And finally doing a complete analysis of the trial from a quality and compliance perspective. The complete analysis also helps in improving the overall management of the trials including tracking and management of the inventory of products." Normally, 1-1.5 percent of the annual sales revenue is spent on IT implementation in a pharma firm. "IT has to be very dynamic and aligned with the business needs. The IT implementations are increasing and the emphasis is on how to increase the efficiency and output by inventing into technology and keeping a constant headcount," said the official. E business is the latest means of leveraging technology by way of webcasting and web conferencing. Clearly companies are considering investing in IT to boost their efficiencies in product development and services. Ch. Srinivas Rao with Rolly Dureha in Delhi and Narayan Kulkarni in Mumbai   ]]> <![CDATA[Pall magnifies focus on Asia]]> https://biospectrumindia.com/news/95/2491/pall-magnifies-focus-on-asia.html https://biospectrumindia.com/news/95/2491/pall-magnifies-focus-on-asia.html Fri, 12 May 2006 11:36:00 +0530 Pall magnifies focus on Asia Pall magnifies focus on Asia Holly Haughney, vice-president Vinay Joban, general manager Pall Corporation recently announced key initiatives to increase its commitment to the life sciences market in Asia. It has added leading industry experts and key executives to its regional team as part of the company's global initiative of aligning with customers worldwide. These initiatives include building a strong Pall infrastructure throughout the region and furthering the company's focus on India, China and Southeast Asia. Pall's biopharma business in Asia grew by 14 percent over the last fiscal year largely because of the solid foundation of expertise and technological capabilities built throughout the region. Pall will continue to look for ways to bring its industry-leading filtration, separation and purification products closer to customers and these newest initiatives reinforce its commitment to grow in Asia. Holly Haughney, vice-president, Pall BioPharmaceuticals Marketing Asia and Vinay Joban, general manager, Pall Life Sciences India, share their thoughts on Pall's renewed focus and interest in Asia and India. Holly Haughney, who has relocated to Bangalore, and in her new role, would manage the biopharmaceuticals marketing teams throughout Asia, including China, India, Korea, Southeast Asia, Australia, New Zealand, and Taiwan. She will coordinate and foster communications within these areas and across the region working with product managers, application managers and the R&D teams. She is also responsible for developing relationships with key universities, regulatory authorities and industry groups in Asia. Vinay Joban will be responsible for expanding Pall Life Sciences' Indian operations. How are you strengthening your India presence? To meet technical and training needs, Pall is opening a new center of excellence in Bangalore this year. The versatile center will provide India's pharmaceutical, biotechnology and discovery marketplace with a full range of total fluid management solutions. It will include a state-of-the-art process proteomics lab designed specifically to help customers speed the discovery process, a training facility and a validation laboratory to meet the growing need for support as Indian companies enter the highly regulated drug export market. What is your China focus? In China, where Pall is already recognized as an industry leader with offices in Beijing, Guangzhou, Chengdu, Changchun and Shanghai, Dr Joe Gu joins as vice president, Pall Life Sciences China. Dr Gu is charged with leveraging the many opportunities afforded by the region, specifically in the economically fertile East China market. With plans to build a center of excellence in Shanghai this year, Pall will play an even larger role in advancing the market. By broadening its offerings and capabilities throughout China, the company can work closely with local customers to help them optimize operations, expedite process validation and participate in the transition to disposable processing. The emerging opportunities in China are however not limited to the Yangtze region. Anticipating increases in demand, Pall is emphasizing both internal and customer training throughout China. The company's Storm program, for instance, offers technical seminars in all key biopharmaceutical production locations in China on a variety of topics ranging from sterilizing filtration to enhancing API production. What are your initiatives in Southeast Asia and beyond? Recent Pall initiatives in China and India further augment an infrastructure that includes offices throughout the Asia Pacific region, including Australia, Indonesia, Japan, Korea, Malaysia, New Zealand, Philippines, Singapore, Taiwan, Thailand and Vietnam. Pall began operations in Southeast Asia in 1984, with the opening of an office in Singapore. Today, it continues to build on its strength in the region. In 2003, for example, a larger office was opened in Singapore, and last year we established a presence in Indonesia. Hans-Peter Mueller, who is the regional manager, Pall BioPharmaceuticals Southeast Asia, moved to Singapore from Pall Germany in late 2004. More recently, that office added Hazelle Lam, a specialist in protein purification and chromatography, to serve as regional marketing manager, Pall BioPharmaceuticals Southeast Asia. Singapore has a very strong base of multinational API manufacturers and is quickly developing into an R&D and manufacturing hub for MAbs (monoclonal antibodies) and recombinant vaccines. Strong government support in the life sciences area in general also has been instrumental in furthering the market. How do you see the opportunities in India and China? Market growth in India and China, which are leading the charge in the emerging Asian pharmaceutical industry, was a major impetus behind several of the Pall programs. The Indian Pharmaceutical and Healthcare Market Annual Review (2005) reports that the Indian pharmaceutical industry is growing at the rate of nearly 9 percent annually. According to a report from The Golden Triangle Organization Inc., China's more than $20 billion pharmaceutical market will continue to experience double-digit growth rates till 2010. ]]> <![CDATA["Packaging industry has a great scope for entrepreneurship and marketing"]]> https://biospectrumindia.com/news/95/8459/packaging-industry-has-a-great-scope-for-entrepreneurship-and-marketing.html https://biospectrumindia.com/news/95/8459/packaging-industry-has-a-great-scope-for-entrepreneurship-and-marketing.html Fri, 12 May 2006 11:34:00 +0530 New Page 1 "Packaging industry has a great scope for entrepreneurship and marketing" Sudip Dutta, MD, Dutta Group of Companies What is the present scenario of the packaging industry for the pharmaceutical/biotechnology industry in India? The packaging industry for the pharmaceutical/biotechnology industry has undergone a sea change in the past decade, coming out with a number of innovations and solutions that are consumer-friendly besides being safe and aesthetic. It is no surprise that the packaging for the pharmaceutical/biotechnology industry in India is considered a sunrise industry, worth about Rs 25,000 crore and growing at a rate of 12-14 percent annually. The Indian packaging industry for the pharmaceutical/biotechnology industry is extremely competitive and is now bringing this competitiveness to the world market in many forms. The competitive advantage that will make all the difference is its competitive edge in R&D, which costs one fifth to one seventh of what it does in the US and EU. The domestic packaging industry for the pharmaceutical/biotechnology industry is offering the products in a cost effective manner by meeting the international standards. The Indian pharmaceutical/biotechnology industry is leaping towards global effectiveness and joining hands with the research based packaging industry so as to use their expertise and experience in application of the novel viable alternatives developed by them. Effective partnering and not reinventing the wheel, will be the only viable way of entering the global arena and maintaining a position of repute amongst the global players. How do you see the future of packaging industry for the pharmaceutical/biotechnology industry in India? The packaging for the pharmaceutical/biotechnology industry is one of the fastest growing sectors. As noted earlier, it is a sunrise industry with a great scope for entrepreneurship and marketing. The packaging industry is in a heterogenous phase. The total packaging industry is worth about Rs 65,000 crore and growing at a rate of 15 percent annually, which is almost double to the growth of the global packaging industry. What kind of support is the government offering to companies in the packaging industry? The government has given due importance to the packaging industry in this Budget in comparison with the last Budget through concessions announced for major bulk plastics like PVC, LDPE and PP- the duty reduction from 10 percent to 5 percent, duty removal on naptha for plastics and reduction of duty on packaging machines from 15 percent to 5 percent. The government has also implemented measures in conjunction with drug manufacturers to enhance educational programs aimed at physicians, pharmacists and other health care professionals about their role in identifying, minimizing exposure to and reporting counterfeit drugs. Such incentives in the form of tax concession, tax rebates, common toll and octrai would encourage the companies in the packaging industry to meet global challenges. Considering the opportunity and growth of the packaging industry, what are your future plans? We are mainly into the businesses of printing, coating and packaging for the pharmaceuticals/biotechnology industry. Fully dedicated to the healthcare sector, the group has printing, PVC film, aluminum foil rolling mills, packaging and PVDC coating units in four locations in the country. This is a very exciting time at Dutta Group of Companies with a drive towards both consolidation and major expansion. To meet growing international and domestic demand, we are expanding our capacity to over three times, with the foil plant in Daman, Vasai and Goa adding 500 tons capacity being set up to meet growing capacity and expansion plans. We are expanding our business horizons in the area of flexible packaging and other foil related products. We are investing about Rs 100-120 crore over the next two years for setting up an additional PVDC coating unit in Goa, second aluminum foil rolling mill in Daman, new printing unit in Baddi, Himachal Pradesh, upgrading all existing units in line with current good manufacturing practices (cGMP) standards, green fields converting unit in Daman in line with the US FDA standards and castor and aluminum sheet rolling unit. As a part of our overseas plan, we have shortlisted three companies in Latin America for acquisition. The move is aimed at strengthening our supply channel in these markets. We have similar plans for the US and European markets as well. Our alliance with GARMCO of Bahrain will support us for uninterrupted procurement of foil stock for our aluminum foil rolling mill. For the proposed expansion, we are planning to raise funds of about Rs 150-200 crore from capital market through the initial public offering (IPO) that is planned by July this year. The funding will help us reach the set target of Rs 500 crore by 2008 from the current turnover of Rs 125 crore from the three flag ship companies Ess Dee Aluminum, Flex Art Foils and Atlanta Vinyl. Narayan Kulkarni ]]> <![CDATA["Opportunities are aplenty with India being in global focus"]]> https://biospectrumindia.com/news/95/1713/opportunities-are-aplenty-with-india-being-in-global-focus.html https://biospectrumindia.com/news/95/1713/opportunities-are-aplenty-with-india-being-in-global-focus.html Fri, 12 May 2006 11:31:00 +0530 New Page 1 "Opportunities are aplenty with India being in global focus" S Gopal, MD, Scigenics Biotech Pvt Ltd As a manufacturer of equipment, where do you find the opportunities in the life sciences and biotechnology industry in India? We find requirements in every area of life sciences and biotechnology i.e. agriculture, basic research, production of various biotech-based products thus providing ample opportunities and width for us to grow. What kind of support is the government providing to supplier companies like Scigenics Biotech? In our opinion, the government has not yet looked at bioequipment manufacture close enough to encourage its growth though several hundred crores of rupees worth of equipment are imported into the country. Our request is that taking note of the fact that our country almost missed the bus to be along with other countries in semi conducer/computer hardware manufacture, we should ensure in the field of biotechnology, we as Indians should be at the forefront in both hardware/software. In both the areas, India has the necessary skills and it needs to be nurtured on a mission mode. How are the domestic biosuppliers placed in the competitive market? Even established domestic biosuppliers are currently facing the heat both from the east and west. One has to admit that conservatism exists among domestic manufacturers as far as addressing the specifications of the equipment is concerned. While most of us manufacture equipment addressing the essential requirement, the overseas products are able to address the additional features better. Besides, the cost of equipment from the east, particularly Korea and China are comparable if not cheaper to domestically manufactured products. Customers also realize the disadvantage of importing products due to fly-by-night nature of some of the manufacturers/distributors. Entrepreneurs prefer on taking up dealership instead of setting up their own manufacturing units in India. Why is it so? Entrepreneurs prefer dealership to manufacture base, owing to severe hardships faced on account of statutory laws and other strictures. Valuable time and resources have to be spent on adhering /deciphering statutes like excise duty, sales tax, labour laws, infrastructure inadequacy among other things, forcing energetic people to seek easier way to sustenance i.e distributorship. This is a very serious issue, which in long term will be ruinous to the economy of the country. In what way is the government encouraging entrepreneurs to invest in the manufacturing of equipment necessary for life sciences/ biotechnology industry? It is time the government looked at this industry as sunrise sector and clearly envisage policies for organized growth, and not repeat mistakes in semiconductor/hardware industries. The government should encourage small scale industries (SSI) in this sector to perform through liberal banking assistance. Waiver of exorbitant tender fee, EMD and providing incentives similar to exports will support the SSIs. Though SSIs are exempted as per government rules from payment of EMD/security deposit etc., government institutes like the CSIR/ ICAR/ICMR and universities do not accept and choose to ignore, which result in heavy blockage of working capital. How you see the growth of global life sciences/biotechnology industry in general and the Indian industry in particular in the next 5 years? The opportunities are going to be aplenty with India being in global focus. Biotechnology is going to address every walk of life. Our human resources are going to be the biggest contributor. Our biotech industry is going to grow by leaps and bounds catering to both domestic and international needs and with that biosuppliers are going to have their hands full. What are your future plans for Scigenics Biotech? SCIGENICS Biotech has been an entrepreneurial venture since its inception in 1997 in manufacturing of ORBITEK range of Shakers, specifically addressed to the field of life sciences and biotechnology. The ORBITEK product range has been expanded to include hybridization chamber, growth chamber, incubators, roller culture apparatus etc. With close to 1500 installations in leading companies, research and education institutes coupled with consistent repeat orders, stand testimony to our customer satisfaction and trust. Our R&D unit has an approximate floor area of 600 sft and the factory has an approximate floor area of 6000 sft. With 8 offices including distributors, we have employed 40 people. The annual turnover for the last year 2005-06 was Rs 203 lakh. Narayan Kulkarni ]]> <![CDATA[Comprehensive stem cell policy soon]]> https://biospectrumindia.com/news/95/1791/comprehensive-stem-cell-policy-soon.html https://biospectrumindia.com/news/95/1791/comprehensive-stem-cell-policy-soon.html Fri, 12 May 2006 11:26:00 +0530 Mashelkar Committee Report in force Comprehensive stem cell policy soon National guidelines on stem cell research and therapy are on the anvil The Indian Council of Medical Research (ICMR) and the Department of Biotechnology (DBT) are jointly finalizing the draft national guidelines on stem cell research. The draft guidelines are expected anytime based on which the final policy will evolve. Recently the final meeting of the expert committee in charge of framing the national regulatory guidelines for stem cell therapy was held and it invited comments from all stakeholders on the draft before finalizing the regulatory norms. These views have been received and are being incorporated. The draft guidelines will be hosted on the ICMR/DBT website inviting comments from the general public. It is believed that the document will be available in the public domain for about three months, post which the comments will be collated, analyzed and incorporated, if required, in the final document. These guidelines essentially provide a framework and practical guide for researchers after taking into account the scientific, ethical and legal aspects for derivation, propagation, banking and use of stem cells for research and therapy. It comprehensively addresses the entire gamut of issues related to not only the ethically sensitive embryonic stem cell arena but also the adult stem cells and the cord cells. The national guidelines will reaffirm India's current stand in this arena that stem cell research should be promoted in the country with appropriate safeguards. They will be of a 'regulatory nature' and are aimed at giving a direction and thrust to stem cell research in the country, in view of its potential clinical use. In the case of embryonic stem cell, the guidelines provide a complete oversight process that will ensure that the research is conducted in a responsible and ethically sensitive manner and complies with all the regulatory requirements pertaining to biomedical research in general and stem cell research in particular. They cover all derivations of human embryonic stem cell lines and research that uses such cells. A salient feature of the guidelines is setting up a of a high level committee which will clear any research proposal involving previously derived human embryonic stem cell lines; all proposals will have to be submitted to the committee which will review them speedily. Besides elaborating on what areas of research are permitted, it also outlines, "what should not be done" or is not permissible. For example, embryonic stem cell research involving in vitro culture of any intact human embryo for longer than 14 days is not permitted nor is research involving introduction of embryonic cell into human or non-human primate blastocyst. The guidelines also ensure that only surplus embryos will be used for research after obtaining permission from the couple and generating embryos for the sole purpose of obtaining stem cells is strictly banned. Some other prohibited research areas include transfer of blastocysts/human embryos generated by SCNT/parthogenetic to a human or non-human uterus; research involving the directed non-autologous donation of stem cell lines to an individual; research in which any cells of a pluripotent nature are combined/grafted with a human or non human embryo/foetus. The document also outlines the criteria for derivation and study of human somatic stem cell lines from the umbilical cord and placenta or human somatic tissue; Research on anonymized human embryonic stem (ES) cell lines, embryonic gamete (EG) cell lines or somatic stem (SS) cell lines; Research involving the grafting of human ES, EC or SS cells into non human adults or legally competent humans. In addition, the guidelines elaborate on the related technical issues like the banking and distribution of human ES cell lines, the critical informed consent process, protecting the anonymity and privacy of the donor, etc. Once the final guidelines take shape, it will be imperative to pass them as legislation so that the stipulated norms can be strictly enforced. The deterrent of punitive action will go a long way in preventing unethical and fraudulent research as was recently seen in the Korean stem cell researcher, Hwang Woo Suk's case. The national guidelines should thus become the Holy Grail of any future research foray in the stem cell arena. Rolly Dureha ]]> <![CDATA[Mashelkar Committee Report in force]]> https://biospectrumindia.com/news/95/2877/mashelkar-committee-report-in-force.html https://biospectrumindia.com/news/95/2877/mashelkar-committee-report-in-force.html Fri, 12 May 2006 11:20:00 +0530 Mashelkar Committee Report in force Mashelkar Committee Report in force "This will give a tremendous spurt to the r-pharma industry which has been asking for a hassle free environment." -Dr RA Mashelkar, director general, CSIR The report on recombinant pharma will give a huge boost to the biotechnology industry. The Ministry of Environment and Forests (MoEF) has adopt- ed the recommendations made by the Mashelkar Committee (Task Force on r-Pharma) to streamline the regulatory process for the approval of all recombinant DNA products. The recommendations were approved with minor amendments by an inter-ministerial meeting convened by the MoEF under the chairmanship of Dr Prodipto Ghosh, secretary, Environment and Forests, in the last week of March 2006. The recommendations have been notified with effect from April 1, 2006. The industry is particularly pleased that the government has committed to certain timelines for approvals at different stages as the same practice was being followed by regulatory bodies in developed countries. Hailing the report, Mukund Ranade, president - business development, Emcure Pharma, a Hyderabad-based biotech and healthcare company, said, " This is a welcome move, actually a historic development for the industry. This report will fulfil the long-standing demands of the industry." Dr Vinod Mattoo, CSO, Eli Lilly India opined, "I am delighted. This is a welcome step forward in rationalizing the regulatory environment related to biotech products. The report is well thought of and is a big step forward in streamlining processes. The only caution would be to see the implementation of these recommendations, especially relating to establishment of a team for inspection purposes and the level of training and skill development which will be put in to develop this team." Almost two years back, the Department of Biotechnology (DBT) along with the MoEF had formed a Task Force committee under the chair of Dr RA Mashelkar, director general, Council of Scientific and Industrial Research (CSIR), to review the current framework for recombinant pharma and make suggestions to streamline the regulatory approval process. The National Task Force was set up in April 2004 and its recommendations were made on a consultative approach involving a large number of stakeholders spanning diverse interests. The draft report of the task force was submitted to the MoEF for further action in August 2005, and now the final report is ready for implementation. "I must congratulate the government on the implementation of the report. There have been 11 Mashelkar committee reports so far-on higher education, drug and pharma R&D, spurious drugs, etc and the implementation of this report has been the fastest among all the committees that I have chaired. This will give a tremendous spurt to the r-pharma industry which has been asking for a hassle free environment", said Dr Mashelkar, the architect of the report. "The implementation will considerably rationalize and simplify the regulatory approval procedure without diluting the stringency of scrutiny of the safety and efficacy data as well as environmental safety considerations." -Confederation of Indian Industries (CII) "This is a welcome step forward in rationalizing the regulatory environment related to biotech products." -Dr Vinod Mattoo, CSO, Eli Lilly India "This is a historic development for the industry. This report will fulfil the long-standing demands of the industry." -Mukund Ranade, president - business development, Emcure Pharma According to the Task Force Report, LMOs (Living Modified Organisms) are defined as only those organisms modified by r-DNA techniques through human interventions where the end product is a living modified organism. The report has rationalized the regulatory procedure for five categories of LMOs and they are as follows: Indigenous product development, manufacture and marketing of pharmaceutical products derived from LMOs but the end product is not a LMO This category has been further divided into two parts namely (i) organisms falling under Risk Group I and II and (ii) Risk Group III and above. The approval of the Genetic Engineering Approval Committee (GEAC), which under the MoEF has been acting as the key biotech regulator providing environmental clearance to all products using genetically modified organisms, is required only for organisms falling under Risk Group III and IV. While no approval of GEAC is required for Phase III clinical trials under this category, the Drug Controller General of India (DCGI) will approve the human clinical trials based on the recommendation of the Review Committee on Genetic Manipulation (RCGM) and product approval based on the results of the clinical studies. Indigenous product development, manufacture and marketing of pharmaceutical products where the end product is a LMO In this category, since the end product is a LMO, the probability of risk due to accidental release is higher and therefore the GEAC will be responsible to evaluate the environmental impact caused by handling and large-scale use/release of LMOs. Accordingly the GEAC should consider and approve Phase III human clinical trials. The GEAC should approve environmental release based on the environmental risks Vs. benefits analysis, which takes into consideration the recommendation of RCGM and results of the clinical trials. The DCGI should examine the data on the toxicity, allergenicity and QC tests and recommendation of RCGM before approving human clinical trials. The DCGI should also take into consideration the views of the GEAC on the safety of the product for conduct of human clinical trials from environmental angle. The DCGI should be responsible for evaluation of product efficacy and safety based on the data generated during human clinical studies prior to market authorization. Import and marketing of LMOs as drugs/pharmaceuticals in finished formulations where the end product is a LMO Since this scenario pertains to import of LMOs, the only activity envisaged within the country prior to issue of market authorization is the conduct of human clinical trials and therefore the approval of the GEAC for conduct of Phase III clinical trials as outlined in Protocol would be applicable Import and marketing of LMOs as drugs/pharmaceuticals in bulk for making finished formulation where the end product is a LMO This scenario involves setting up of facilities for formulations and conduct of clinical trials within the country before market authorization. The end product being an LMO approval of RGCM, GEAC and DCGI as outlined for the second category would be applicable. Import and marketing of products derived from LMOs as drugs/pharmaceuticals in bulk and/or finished formulations where the end product is not a LMO Approval of the GEAC is not required for this category. This scenario in terms of environmental risk falls under the least risk category since there is no exposure to LMOs within the country. Therefore approval under Rules 1989 of EPA would not be required. The report also specifies the timelines for various approvals by the regulatory committees-RCGM approval for pre-clinical animal studies: 45 days; DCGI approval for human clinical trials protocol: 45 days; DCGI examination of clinical trial data and response: 90 days; and concurrent DCGI and GEAC decisions: 45 days. Another important highlight of the report is that it has recommended the constitution of a Standing Technical Advisory Committee on Biotechnology Regulation under the chairmanship of an eminent scientist to redress and look into the various regulatory aspects and make issue-based recommendations on case-by-case basis prior to any deviation from the regulatory mechanism. Hailing the report, the Confederation of Indian Industries (CII) in a press release stated, "The implementation will considerably rationalize and simplify the regulatory approval procedure without diluting the stringency of scrutiny of the safety and efficacy data as well as environmental safety considerations. It is laudable that the government has taken serious note of the long standing concerns of the industry and decided to implement the recommendations of the task force that included several industry nominees in addition to representatives and heads of different government bodies". The CII release further added, "The proposed new system clearly separates different scenarios based on their risk potential and creates a graded system of scrutiny with a more detailed assessment for product categories where the risk concern is higher. The earlier system had caused a lot of overlapping responsibilities among different bodies, and duplication of work. The new system will allow each body to focus on its core area of evaluation (biological safety, environmental safety, drug efficacy, etc.) and also reduce the burden of by removing unnecessary workload of these bodies". The clarity on regulation for emerging areas like contract research and manufacturing was also hailed by the CII. Rolly Dureha Comprehensive stem cell policy soon National guidelines on stem cell research and therapy are on the anvil The Indian Council of Medical Research (ICMR) and the Department of Biotechnology (DBT) are jointly finalizing the draft national guidelines on stem cell research. The draft guidelines are expected anytime based on which the final policy will evolve. Recently the final meeting of the expert committee in charge of framing the national regulatory guidelines for stem cell therapy was held and it invited comments from all stakeholders on the draft before finalizing the regulatory norms. These views have been received and are being incorporated. The draft guidelines will be hosted on the ICMR/DBT website inviting comments from the general public. It is believed that the document will be available in the public domain for about three months, post which the comments will be collated, analyzed and incorporated, if required, in the final document. These guidelines essentially provide a framework and practical guide for researchers after taking into account the scientific, ethical and legal aspects for derivation, propagation, banking and use of stem cells for research and therapy. It comprehensively addresses the entire gamut of issues related to not only the ethically sensitive embryonic stem cell arena but also the adult stem cells and the cord cells. The national guidelines will reaffirm India's current stand in this arena that stem cell research should be promoted in the country with appropriate safeguards. They will be of a 'regulatory nature' and are aimed at giving a direction and thrust to stem cell research in the country, in view of its potential clinical use. In the case of embryonic stem cell, the guidelines provide a complete oversight process that will ensure that the research is conducted in a responsible and ethically sensitive manner and complies with all the regulatory requirements pertaining to biomedical research in general and stem cell research in particular. They cover all derivations of human embryonic stem cell lines and research that uses such cells. A salient feature of the guidelines is setting up a of a high level committee which will clear any research proposal involving previously derived human embryonic stem cell lines; all proposals will have to be submitted to the committee which will review them speedily. Besides elaborating on what areas of research are permitted, it also outlines, "what should not be done" or is not permissible. For example, embryonic stem cell research involving in vitro culture of any intact human embryo for longer than 14 days is not permitted nor is research involving introduction of embryonic cell into human or non-human primate blastocyst. The guidelines also ensure that only surplus embryos will be used for research after obtaining permission from the couple and generating embryos for the sole purpose of obtaining stem cells is strictly banned. Some other prohibited research areas include transfer of blastocysts/human embryos generated by SCNT/parthogenetic to a human or non-human uterus; research involving the directed non-autologous donation of stem cell lines to an individual; research in which any cells of a pluripotent nature are combined/grafted with a human or non human embryo/foetus. The document also outlines the criteria for derivation and study of human somatic stem cell lines from the umbilical cord and placenta or human somatic tissue; Research on anonymized human embryonic stem (ES) cell lines, embryonic gamete (EG) cell lines or somatic stem (SS) cell lines; Research involving the grafting of human ES, EC or SS cells into non human adults or legally competent humans. In addition, the guidelines elaborate on the related technical issues like the banking and distribution of human ES cell lines, the critical informed consent process, protecting the anonymity and privacy of the donor, etc. Once the final guidelines take shape, it will be imperative to pass them as legislation so that the stipulated norms can be strictly enforced. The deterrent of punitive action will go a long way in preventing unethical and fraudulent research as was recently seen in the Korean stem cell researcher, Hwang Woo Suk's case. The national guidelines should thus become the Holy Grail of any future research foray in the stem cell arena. Rolly Dureha ]]> <![CDATA[Bangalore Bio 2006 gains momentum]]> https://biospectrumindia.com/news/95/1103/bangalore-bio-2006-gains-momentum.html https://biospectrumindia.com/news/95/1103/bangalore-bio-2006-gains-momentum.html Fri, 12 May 2006 11:17:00 +0530 Bangalore Bio 2006 gains momentum Bangalore Bio 2006 gains momentum The biggest biotech show in the Asia-Pacific is all set to create a new record in June. Over 60 national and international speakers, 350 conference delegates, 120 exhibitors, 20,000 business visitors from over 15 countries, and various states of India are expected to convene at the premier annual event for the biotechnology industry, Bangalore Bio 2006. The biggest biotech show in the Asia-Pac region, now in its sixth year, which features conferences, business forums and trade exhibition, will be held during June 7-9, 2006 at the Palace Grounds in Bangalore. This flagship biotech event is promoted by the Government of Karnataka and organized by the Vision Group on Biotechnology. Bangalore Bio today is a unique platform for the biotech fraternity to leverage partnering opportunities and forge new alliances in the biotech industry globally. This forum presents a platform to showcase products, services, and transform concepts into markets and explore investment. The focal theme for Bangalore Bio 2006 is DNA-Discover, Nurture, Accelerate. The event this year includes a strong international participation from the European Union, Holland, France, the UK, Germany, Japan, Belgium, Bavaria, Pennsylvania, and Singapore. There is also a very strong domestic participation. Various state governments like Himachal Pradesh, Rajasthan, Chattisgarh, Uttar Pradesh, Maharashtra and Andhra Pradesh have already confirmed their presence. Bangalore Bio today has emerged as the premier event in the country not only because of the preeminent position of Bangalore, but also because Bangalore has one of the most exciting biotech ecosystems. The industry and the state government are keen to promote biotech in the state. Kiran Mazumdar Shaw, chairperson, Vision Group on biotechnology and CMD, Biocon Ltd, informed, "Bangalore is evolving as an interesting ecosystem for biotechnology. Other states are also taking the initiative to follow the Bangalore model of success. To create a biocluster, one needs a mindset of entrepreneurship and Bangalore has paved the way in this regard. For instance, to accelerate entrepreneurship, companies such as Biozeen have set up training programs for bioprocessing. The institute of clinical research has been set up and will help to enhance clinical development in the country. We need to expand infrastructure, not just roads and airports but also patent infrastructure and service infrastructure. The government should take the lead for special initiatives on biofuel and bioagri technology." Bio Awards Nite The Bio Awards Nite recognizes the contribution of eminent Padma Awardees for their outstanding achievements in the field of Science & Technology. Awards for best stalls will be presented to the exhibitors for innovative stall designs and creative display of products. This year the best entries in Poster Session will also be awarded. The Awards Nite will conclude with a gala celebration, entertainment and dinner.   CEO Conclave The CEO Conclave is an exclusive industry get-together of CEOs, R&D heads, policy makers, VCs, investment bankers, etc. On this occasion, "Vision talk" will be delivered by India's top scientist, Dr RA Mashelkar, director general, CSIR and secretary, DSIR. The evening will conclude with an industry networking dinner. Commenting on the initiatives and progress done by Karnataka, MK Shankaralinge Gowda, secretary, Department of IT, Biotechnology and Science & Technology, Government of Karnataka, said, "The 100-acre biotech park in Bangalore will be operational by the end of 2006 near Electronic City. This project has been awarded to the National Building Construction Company. Karnataka supports investments from biofuel companies. Citing the example of the Indian Railways, biofuel farming, where-in 90,000 hectares of land have been allocated for this purpose. About two new biotech companies are being set up every month. Karnataka has attracted the highest VC fund in Asia (to the tune of $100 million). Outsourcing of R&D has immense potential, 20 of the 70 commercial labs are in Karnataka. We look forward to making Bangalore and India Knowledge Process Outsourcing hub. Further, Karnataka will support stem cell banks and other new areas of biotechnology." And Bangalore Bio serves as the perfect platform to promote and nurture the growth of biotech. Sixth Bangalore Bio highlights International Conference India's biotech revolution-be it in biopharma or bioagri or clinical research or bioinformatics-is at an important juncture. It is one of the top emerging biotech destinations today. To highlight these achievements and comprehend further development, there is a focused multi-track conference. These sessions are expected to be addressed by experts like Dr Nermeen Varawala (vice president, business Development, PRA International, UK); Dr DK Srivastava (professor, department of chemistry, biochemistry and molecular biology, North Dakota State University, US); Dr KK Tripathi (advisor, Department of Biotechnology, Government of India); Dr Lakshmi Kumaran (Consultant, Lakshmi Kumaran and Sridharan); Dr Anil Paul Kariath (president, training consulting, founder director Biozeen, Bangalore Biotech Labs Pvt Ltd); Dr Naveen Rao (medical director, MSD Pharmaceuticals); Dr Mohammed Alavijeh (co-founder and managing director, Pharmidex, UK); S Abhaya Kumar (chairman, Life Cell India); Dr Franck Molina (Center for Pharmacology and health biotechnology, France); and Simon Best (Chairman, Biotech Industry association, UK).   Agri Biotech Day Another important feature of Bangalore Bio 2006 is a focused session on BioAgri on the third day. India, undoubtedly, is making rapid strides in agri biotechnology and several knowledge-sharing initiatives have been launched. This session is aimed at showcasing India's experience and progress in agri biotechnology. "And the Agri-biotech Day at Bangalore Bio 2006 has been conceptualized to strengthen transnational partnerships and throw light on recent advances made in molecular genetics, informatics, and genomics," informed Dr KK Narayanan, president, ABLE and managing director, Metahelix. The sessions will cover bioagri issues related to transgenic crops, functional foods and nutraceuticals, bioenergy and biofuels, biofertilizers and pesticides, etc.   Build Your Business (BYB) Forum Build Your Business (BYB) forum is another important aspect of Bangalore Bio 2006 and will be organized at the palace grounds, Bangalore. According to the event organizers, MM Activ, this year's Bangalore Bio has received overwhelming response from the international participants. For the first time, over 50 companies from various countries are participating. Delegations from France, the UK, the Netherlands, etc. have confirmed their participation to explore the various opportunities in India. Build Your Business forum is a networking platform for buyers-sellers of various organizations. The Build your Business Forum is aimed at bringing together people across the industry on a single platform. Trade show participants, business visitors and conference delegates can use the facilities to hold meetings and explore collaboration, investment, marketing, and trade opportunities. Facilities offered at BYB include corporate presentation slots, discussion booths, business center and conferencing facilities. This B2B session will be an exclusive inter corporate interaction point and will be held at the exhibition site. Interested companies and individuals can book their space online for the meet.   Poster sessions This year Bangalore Bio is adding one more exclusive feature, the "Poster Session for Leader Prospects" in conjunction with the international conference. About 50 path-breaking ideas will be presented by young researchers covering a wide gamut of topics in health biotechnology, cell biology, bioagri and bioinformatics. "The research papers (posters) are chosen from hundreds of abstracts received from young researchers, scientists and technocrats working in universities, R&D labs, various government departments or in the private sector," informed Jagdish Patankar, managing director, MM Activ. "This platform gives unique opportunity to the emerging talent to share their innovation and research aimed at solving unmet problems in the area of biotechnology. It is also a great opportunity for the biotech industry to explore future commercial and business opportunities," he added. The poster session will be held at the National Science Seminar Complex, Indian Institute of Science (IISC) Bangalore. An eminent panel of judges comprising of leading industry professionals and the Department of Biotechnology will be adjudging the abstracts for their prospective commercial potential and viability. The best three abstracts will be felicitated at the "Bio Awards Nite".   Trade show The trade show at the premier event is designed as a platform to showcase technologies, products, research and services. The exhibition is expected to attract over 20,000 business visitors. Over 140 companies and research institutes from India, France, the Netherlands, the UK, Pennsylvania, Belgium, Japan, and Singapore are participating in this exhibition. The exhibitors space has been designed to accommodate separate pavilions like BioNations and BioStates; BioInfrastructure; Process Engineering and Equipment; R&D; Bioinformatics; Clinical Research; BioAgri; Education and careers; BioPharma; Institutional Investors and VC Funds; Consulting and Allied Services; Diagnostics and Instrumentation. BioSpectrum Report   ]]> <![CDATA[Biotechnology meets fashion]]> https://biospectrumindia.com/news/95/2937/biotechnology-meets-fashion.html https://biospectrumindia.com/news/95/2937/biotechnology-meets-fashion.html Fri, 12 May 2006 11:14:00 +0530 Biotechnology meets fashion Biotechnology meets fashion BIO 2006 was used as a platform to display apparels, gowns and other dresses made from polyactic acid (PLA), a polyester derived completely from corn rather than petroleum. A tall Chinese model sashayed down the aisle in a cream hemp/silk gown and another Korean supermodel did the same in a beige patterned gown during the BIO convention in Chicago. Fashion and biotech. What is the connection? Lots. The models were wearing the gowns which had the overlay made with Ingeo, a fiber made using biotechnology tools. And these clothes were designed by some of the top designers like Oscar de la Renta, Halston and Elisa Jimenez. And there were other models and even some BIO staffers who did the catwalk at a special session in a variety of biotech-based clothes: a racerback tank dress, Korean crew cream jacket, short sleeve shirt with floral accents and a sheer Ingeo gown with wings. Ingeo is one of the world's first commercially available family of fibers made entirely from renewable resources. Developed by NatureWorks, a subsidiary of Cargill, the fiber is produced from natural plant sugars and corn using a patented technology. The polylactive polymer is branded as Ingeo and is biodegradable. Biotech fashion show is gradually becoming mainstream. The first show was held as the FutureFashion Runway show in February 2005 during the New York Fashion Week by a group of designers under the aegis of Earth Pledge. The New York Times declared the elegant evening gown designed by de la Rent for the show which had ethereal layers of corn fiber and an ivory hemp/silk blend to be a "new collectible." And that began a rush for these fashion garments. The show had other garments spun with fibers from bamboo, cotton and other such materials. Experts predict that fashion garments and clothings and home furnishings made from these new class of biodegradable, environment-friendly products could become a $15 billion business in a few years, emulating the success of organic food and beauty products. Bio-based textiles is the new rage. Not just fibers, biotech is providing environment-friendly textile manufacturing processes. Take the case of stonewash jean. Earlier, the jeans were washed with acid and pumice stones which were extracted from strip machines using heavy machinery. This energy intensive process has been replaced by enzymes. The enzyme-based "stonewash" process requires much less energy and it does not damage the jeans fabric. Similarly, enzymes are increasingly used to soften fabrics for making khakis and other clothing. Enzymes are used to treat and degrease leather instead of petroleum-based solvents. Bio-based fabrics is all set to swamp the shelves around the world in a few years. Syngenta, DuPont pact broadens product offers Two seed industry leaders, the $ 8.1-billion Syngenta and the $ 26.6-billion DuPont have formed the seed industry's first ever joint venture to provide their proprietary corn and soybean seeds, genetics and biotechnology traits to farmers in North America and expand the joint offering worldwide soon. The joint venture, GreenLeaf Genetics, will have equal shareholding by the Swiss company Syngetna and the US-based Pioneer Hi-Bred International, a subsidiary of DuPont. The two companies have decided to cross license certain corn and soybean traits so that each company will market independently under their own seed brands. The agreement includes rights for Syngenta to market the new Optimum herbicide tolerant train developed by DuPont. The announcement was made at BIO 2006 Chicago. "This is outstanding news for growers and the seed industry because it will make available a new and unique pool of corn and soybean traits and genetics from both companies' research efforts. As a result, North American growers will have access to broader product choices and technologies," said Mijke Mack, COO of Syngenta Seeds. "The joint venture and the licensing arrangements bring together the strength of two industry leaders to deliver new technologies to the market more quickly," said Dean Oestreich, president of Pioneer and a vice president at DuPont. Through the cross-licensing agreements, Syngenta will receive a global license to the Optimum trait, a DuPont proprietary glyphosate and ALS chemistry tolerant trait for both soybeans and corn to be marketed in conjunction with its Agrisure brand of traits. DuPont will receive the global license to Syngenta's insect resistance technology for European corn borer, corn rootworm and broad lepidopteran control as it develops the next generation of insect traits. Narayanan Suresh ]]> <![CDATA["We need to move to a biofuel future"]]> https://biospectrumindia.com/news/95/4571/we-need-to-move-to-a-biofuel-future.html https://biospectrumindia.com/news/95/4571/we-need-to-move-to-a-biofuel-future.html Fri, 12 May 2006 11:07:00 +0530 New Page 1 "We need to move to a biofuel future" Bill Clinton was a strong supporter of biotechnology during his eight years as the President of the US. In fact, he was instrumental in bringing warring scientific groups together to quickly unveil the Human Genome Map in June 2000 from the White House. Six years out of office, Clinton continues to use the tools of biotech and his charm to bring relief to AIDS patients in Africa and other developing countries through a foundation headed by him. Clinton was at the BIO 2006 in Chicago to charm the biotech industry once again and goad it to deliver more to the cause of humanity. Extracts from his wide-ranging remarks at a Special Plenary session of the BIO convention on April 12, 2006 in Chicago. I think the use of agricultural technology, which usesless fertilizer, takes better care of the soil, increases productivity and could be transferred at low cost through seeds to poor farmers in developing countries is a good thing. We need more people to be able to grow their own food and feed themselves. I think the most important thing; however, you (biotechnologists) can do is to give us a different energy future. The US is contributing 25 percent of the world's greenhouse gases; that's oil and coal. We have to go to clean coal technology, which is somebody else's job. But we also need to recognize that 70 percent of our oil consumption is in transportation. If you look at America's greenhouse gas consumption, it's basically about a third in transportation, a third in manufacturing and electricity generation and a third in buildings: homes and office buildings, structures of all kinds, and there's a lot to be done in conservation. But in the fuel area, clearly, we need to go to biofuels. We need to move to a biofuel future. And in my opinion, we need to move to a biofuel future based more on cellulistic fuels than corn, which is a principal contributor to ethanol now. Why? Because the conversion ratio is better. If the goal is not only to have clean fuels but to reduce the use of greenhouse gases, then you want stuff that's lying around anyway, that you didn't have to burn oil to produce in the first place. And there's all kinds of agricultural waste that can be used. There's wood waste that's lying around. I could have fueled every shrimp boat in the Gulf with the fallen trees and shrubs and other greenery that was all over the ground from Alabama to New Orleans if we'd had the plants available and the distribution mechanisms available. And at $65 oil, biodiesel for those shrimpers is $3.00 a gallon (approx. 4.5 liters). With the tax subsidy available in the law now, we could sell them biofuels for about $1.80. And if you're in the shrimp boat business, the difference between spending 18 percent of your revenues on fuel and 33 percent is the difference between making a living and going broke. The thing that's important to me about this, is that if we made a serious decision to go to a clean energy future, we would reverse the declining wages problem. Why? Because if we want America to stay in a global economy, where more and more of our jobs are in competition with others, in every single decade and maybe every 5 to 6 years, we have to keep finding a source of new jobs, that are good jobs, that pay well and create strong consumers. In the next decade, I think biotechnology can replace energy as the main source of new jobs because it'll take us about a decade to reach the full implications of the sequencing of the human genome, so that we will be able to apply it to all kinds of diseases and conditions, develop vaccines, develop preventive strategies, be producing all kinds of products and services that we never even dreamed of before. But first we've got to get the energy thing right, and then in the next decade, if I'm around, I'll be talking to somebody like this about all the things we should be doing to generate all the applications that our understanding of the human genome will make possible. And in terms of the people who have genuine questions about this, I don't think there's anything inconsistent with beef or organic farming and supporting genetic developments. When I was Governor of Arkansas, we grew 40 percent of America's rice crops and we did a lot of experimental rice development. At our experiments stations, we had over 200 different varieties of rice. Now every time we bred a new variety, it was genetically modified. And in America, as we're becoming more of an immigrant nation, we're genetically modified. One of the things that we learned when we sequenced the human genome is that all human beings are 99.9 percent the same, all the wars, all the fights, all the hatred between people of different races and ethnic groups was all over one-tenth of one percent of our genetic structure. It makes you see just how silly it is when we think our differences are more important than our common humanity. I believe that the 21st century will be the most exciting period in human history. I do not believe, that even with the threat of terror and the looming threat of these weapons of mass destructions, I think it is unlikely that as many people will be murdered by crazy politicians as were murdered in the 20th century. Keep in mind, we had two World Wars; two horrible purges in the former Soviet Union; a horrible purge in China, 2,000,000 people killed in Southeast Asia in the slaughter in Cambodia; and a lot of horrible problems elsewhere. In the 90s, 10 percent of Rwanda disappeared in 90 days. I think we've got a chance to avoid that, but we have to deal with climate change. We have to deal with the security threats. We have to deal with the prospect of global diseases because of globalization; and we have to get the half of the people that aren't part of this group deal into the mix, which is why I was glad to see all the farmers here from developing countries today. In all these areas, biotechnology is going to be critical and all the people like me or Bill Gates or everybody who wants to contribute to the non-governmental sector, everything we hope to do to build a world that will be fit for our children and grandchildren, will depend upon continued advances in biotechnology. Let's not be defensive. Let's not hide the evidence. Let's invite people always to find evidence that something that we're doing, whether it's you, me or anybody else is wrong. But let's stick with the evidence and look to the future. I think, on balance, it looks pretty good. ]]> <![CDATA[Global biotech crosses $60-billion mark]]> https://biospectrumindia.com/news/95/1911/global-biotech-crosses-60-billion-mark.html https://biospectrumindia.com/news/95/1911/global-biotech-crosses-60-billion-mark.html Fri, 12 May 2006 10:59:00 +0530 Global biotech crosses Global biotech crosses $60-billion mark Revenues of publicly traded biotech companies worldwide grew 18 percent in 2005 to $63.1 billion, an all-time high in the sector's 30-year history. E&Y counts public companies grew in double digits to cross industry revenues of $60 b Asia-Pacific becomes first region to achieve aggregate profitability in biotech India, China continue to attract attention and partnership deals in 2005 Aggressive Indian investments in stem cell research, bioinformatics, vaccine delivery systems- The global biotechnology represented by publicly listed biotech companies, has crossed the $60 billion industry revenue mark in 2005, according to the 20th anniversary edition of Beyond Borders: The Global Biotechnology Report 2006 by leading professional serv ices firm Ernst & Young. The report was released at a special session of the BIO Annual Convention 2006 in Chicago. The releasing of the 20th annual report also saw the rechristening of the E&Y division which produced this report, as the Global Biotechnology Center. "When we released the first report, there were many skeptics. Now the industry has proved that it is here to stay. And we also know know that sky is the limit for biotechnology," remarked Donn Szaro, E&Y global leader on biotechnology while unveiling the report at a crowded session. The session coincided with the plenary speech by former US President Bill Clinton. Strong performance and growth globally By every performance indicator, the global biotechnology industry showed robust growth in 2005. "Since our first report 20 years ago, we've seen historic scientific advances and dramatic changes in market conditions combine to produce a rapidly maturing industry," added Szaro. "The global biotechnology industry's revenues are growing at strong rates; product approvals are bringing innovative drugs to market, and the long-elusive goal of profitability is quickly approaching," said Donn Szaro. Key highlights: Revenues of the world's publicly-traded biotech companies grew 18 percent in 2005, reaching an all-time high of $63.1 billion. As revenues increased, the industry's net loss decreased by a dramatic 30 percent, to $4.3 billion. The United States, Canada, and the Asia-Pacific region collectively improved their bottom line by about $3 billion. In 2005, strong product sales boosted sector revenues in the US biotechnology sector by about 16 percent. The industry secured 32 new product approvals in the United States, including 17 first-time approvals. For the first time ever, European biotech sector raised more than the U.S. sector through IPOs; with number of IPOs at 23, compared to 8 in 2004. The European sector emerges from a lengthy restructuring period and revenues increased by 17 percent in 2005, compared to a 5 percent decrease in 2004. On the financing front, 2005 was the best year ever for the European biotech sector, excluding the genomics bubble of 2000. The global biotech industry raised $19.7 billion in capital in 2005, its second highest total since the bubble of 2000. Major pharmaceutical companies made several large acquisitions as they faced their biggest patent-expiration year ever, with an estimated $23 billion worth of pharmaceutical products losing protection. While outsourced manufacturing and research represents cash cows in the near future, Asian companies will move from the fee-for-service model to the more lucrative, though more risky, innovation model, says the report. According to the report, the biotechnology sector's growth in the Asia-Pacific region outpaces its performance in other parts of the world with a scorching 46 percent increase in revenues. In 2005, Asia-Pacific has become the first region to reach aggregate profitability in biotech. Asian governments see biotech as a natural fit and the next big thing because it is a technology-based industry with tremendous growth potential in the decades ahead. Asian biotechnology executives and policymakers are focusing strategies toward strategic niches in their efforts to remain competitive. Biogenerics segment Outlining the highlights of the Asian biotech sector, Utkarsh Palnitkar, industry leader - health sciences, Ernst & Young India said "India's generics firms are positioning themselves to play a big role in the evolving biogenerics market. With our advantage in information technology and access to well-trained and relatively less expensive human capital, India is also well poised to become a hub for processing and managing clinical data. Further, stem cell research will also help India create a niche" Deals were a key driver in Asia-Pacific, where companies formed partnerships to position themselves in an environment characterized by brisk growth, increasing competition and sweeping regulatory changes. China and India continued to attract attention and deals, motivated by the desire to increase access to these large and growing drug markets, and by the need to lower the costs of drug development. According to the report, number of deals in vaccines was energized by concerns around the avian flu, SARS, and biodefense products, while looming patent expirations led to increased deals in the generics segment. India: Increasing confidence With India becoming a signatory to the Patents Law, the rule of the game has changed for the Indian companies and they are repositioning themselves for increased competition and new niches. With the patent regime coming into force, domestic and international companies, most of who have set up their base in the country, are eagerly conducting research and development activities in India. According to the report, partnering has also evolved from manufacturing and research agreements to active participation in global initiatives in front-end technologies. India was among the 10 nations that co-operated in a project to sequence the rice genome, successfully completed in 2005, it says. The proposal to create the National Biotechnology Regulatory Authority (NBRA) will encourage efficient and professional regulation. The draft National Biotechnology Development Strategy released recently has proposals to give an impetus to the industry. The Indian biotech sector has not only attracted funds from international organizations like the World Bank, but now companies are successfully tapping investors for cash, with some hedge funds also joining the momentum. All this reflects growing investor confidence in the sector. However, the high risk factor has deterred active flow of venture capital into the sector. The report says that finding suitable valuation benchmarks in the Indian biotech sector is often a challenge, and a changing regulatory and policy structure adds to the complexity of valuing companies. "Seed capital to fund startups will be critical for the growth of India's biotech sector and government incentives or initiatives to spur seed capital hold the key to investments in this sector," said Palnitkar. The foreign companies are increasingly recognizing the latent Indian biotech potential resulting in many outsourcing partnerships evolving into equity investments. Similarly, Indian companies are expanding and scaling up manufacturing capacity to become global players. India is rapidly moving from label extension support center to include global pivotal studies and the growing generics industry is boosting the flow of pharmacokinetic studies to the country. Indian companies are identifying areas of comparative advantage and leveraging them to compete globally. Stem cell research While stem cell research has raised some debate in the west, huge investments have been flowing to India in this field, says the report. Similarly, the strategic emphasis in India has now shifted to developing new vaccine delivery systems instead of just manufacturing vaccines in bulk to maintain the cost competitiveness. Changes are also occurring upstream through enhanced capabilities in conducting discovery research, and downstream, primarily in the capacity to manufacture biopharmaceuticals. Cross border services in molecular diagnostics and genetics are expected to grow, given India's strong value proposition in this space, points the report. However, expanding India's highly skilled labor pool will be critical to industry growth. A comprehensive strategy is needed for boosting education in all aspects of biotechnology to provide a clear mapping between education and industry opportunities. Product theme The next big step for India anchors on product theme, as most current research programs bear fruit by end of the decade. The range could be impressive, including biogenerics, novel therapeutics, vaccines, biochemicals, nutraceuticals and cosmeceuticals. This would finally progress to the stage where Indian biotech expands globally. According to the report this will be driven by domestic innovation, competitive cost, availability of valid data, and viable business models that have already been tested in India. Narayanan Suresh in Chicago ]]> <![CDATA[India leads Asian charge for global attention at BIO]]> https://biospectrumindia.com/news/95/1510/india-leads-asian-charge-for-global-attention-at-bio.html https://biospectrumindia.com/news/95/1510/india-leads-asian-charge-for-global-attention-at-bio.html Fri, 12 May 2006 10:56:00 +0530 India leads Asian charge for global attention at BIO India leads Asian charge for global attention at BIO Minister for science and technology, Kapil Sibal and CII Task Force on IPR chairman Ramesh Adige at the GWU Law School. Asian countries, led by China, India, Taiwan and Malaysia made a determined attempt to catch the attention of biotech leaders from around the world during the 14th annual gathering of the industry in April 2006. 'We are a Sleeping Giant in biotech. But don't hesitate to cooperate with a Sleeping Giant," appealed Wang Hongguang, director-general of China National Center for Biotechnology Development. " We have set up a world class regulatory regime and we have a growing $1 billion market. A biotech drug can be developed for $300-400 million in India which will open up a huge market in Asia and other developing countries and also make it affordable for the middle class Americans," emphasized India's minister for science and technology, Kapil Sibal, at the inaugural international ministerial conference which started the annual Biotechnology Industry Organization convention at the McCormik Convention Center in Chicago. Together India and China offered the world the carrot of a combined market of 2.4 billion people who will all need various medicines and health care solutions. The message: Ignore this market only at your own peril. Highlighting the introduction of the advanced intellectual property rights (IPR) regime which allows product patents in pharmaceuticals since 2005, Sibal said the measure has led to a 3-fold rise in filing of patents in India from 4,800 in 2004 to 18,000 in 2005. India was also beefing up the IPR infrastructure with the addition of 200 patent examiners and 13 trade mark experts to the network. China too made a similar pitch. IPR is hot in China, said the senior official. There were some 476,264 patent application filed in the country last year and 214,003 patents were granted in 2005. And nearly a fifth of these were filed by foreign companies and individual, showing a 18 percent jump over the previous year. This was to dispel the impression that China was not very serious about patents. "The Supreme Court of China has increased the risk for those involved in patent infringement," he emphasized. Other Chinese officials presented the strong national support given to the biotech sector. "You can save 70 percent of your research costs, 80 percent of your clinical trials expenses and 30 percent of the manufacturing costs if you do all the drug discovery in China," said another senior Chinese official. Taiwan's minister of state for S&T, Feng Chin Lin, stressed that Taiwan's $5-billion life sciences industry was making rapid strides and the country was becoming a major global hub for clinical trials. Over 13,000 publications on clinical trials were published in the country last year and Taiwan was harmonizing all its regulations to be compliant with global requirements. "It will cost less than 50 percent of the expenses to do clinical trials in Taiwan than in the US or Europe. And we have reduced the average processing time to 43 days compared to 30 days by the US FDA and 60 days by European regulators," the minister, himself a molecular biologist who had studied in Canada told the global biotech industry leaders. Some 357 large, multi-centric clinical trials were being done in Taiwan currently. Bhan makes an impact While Minister Sibal led the Indian charge at BIO with his impassioned speech at the inaugural session, DBT secretary Dr M K Bhan sustained the attention of industry leaders at a special session on India in the afternoon. During the 60-minute session, Dr Bhan gave an overview of India's biotech strengths, the new strategy being put in place to use biotech tools to promote health, increase agriculture yields and promote sustainable economic growth. Dr Bhan highlighted the major features of the new regulatory regime which had been introduced to cut down procedural delays involved in the approval of biotechnology products. Four stakeholders from the sector, Dr M Vidyasagar of TCS, Dr PK Seth, CEO of Lucknow Biotech Park, patent expert Dr Malathi Lakshmikumaran and Yes Bank's life sciences head, Alok Gupta, enlightened the vast gathering about various aspects of India's growing biotechnology industry. Biocon CMD Kiran Mazumdar-Shaw was one of the three panelists at the panel discussion that followed the release of the 20th annual Global Biotechnology Report, Beyond Borders by Ernst & Young. Feng highlighted the fact that the government was very keen on promoting biotech as the engine of growth and has invested over $ 805 million to support the industry recently and has plans to attract $5 billion in private investments in the next five years and $2.2 billion in biopharma R&D by 2010. Not to be left behind, Malaysia's minister for S&T and innovation, Dr Jamaludin Jarjis called for a pan-Asian cooperation and collaboration to take up joint research and development efforts among the Asian countries. "Let us hold an Asian edition of BIO in India first, Malaysia and Taiwan," he appealed as his counterparts from India and Taiwan nodded in agreement. Malaysia was giving the greatest importance to biotechnology as the new engine of economic growth has formulated a policy that will combine the country's strengths in information technology and engineering to use the bioscience tools for national development, the minister said. Taiwan's minister pointed out that the country was producing over 8,000 graduates in biosciences annually to feed the growing biotech industry. "We are ready to engage the world to make this industry a happening one in our country," Feng said. Trade show India had a much bigger participation in the trade show with the India Pavillion organized by the Confederation of Indian Industry having stalls by Jubilant Biosys, Lucknow Biotech Park and Dabur Foundation. The Department of Biotechnology (DBT) also had a big stall to display the country's biotech strengths. TCS and International Biotech Park, Pune had separate big stalls. The Association of Biotechnology Led Enterprises (ABLE) too organized another big pavilion with the participation of Biocon, Bangalore Bio and Government of Karnataka, ReaMetrix, Strand Life Sciences, Aurigene, Metahelix, Advinus Therapeutics and Avesthagen. ABLE and BiOTECCanada also signed a MOU to strive for closer cooperation in the biotech sector between the two countries. The agreement was signed at BIOTECanada's booth at BIO 2006 in Chicago on April 10 by Dr KK Narayanan, MD, Metahelix Life Sciences and president of ABLE and Peter Brenders, president of BIOTECanada. ABLE also organized a special India nite along with Burrill & Co. which was attended by over 300 people who were keen to learn more about Indian biotech and increase collaborations with the industry. India Biotechnology Handbook 2006 brought out specially for the occasion by BioSpectrum in collaboration with the DBT, CII and ABLE was circulated widely to the BIO participants. The handbook provided a ready-reference to the capabilities of India in biotechnology. The Sleeping Giant Chinese officials reeled out an impressive array of statistics to stress the point that it was indeed a major biotech resource for the world. Total sales of China pharmaceutical industry reached $ 44 billion, including $ 31 billion from biomedicines which also covers traditional Chinese medicines. The annual growth of the biomedicine industry is more than 20 percent. More than 30 biomedicines and vaccines are in the Chinese market. Over 150 biotechnology products are in clinical trials. The first gene therapy drug in the world, Recombinant Adenovirus-P53, anti-cancer injection , was developed in China in 2003. The annual output of Chinese fermentation industry stands at $20 billion. China produces 400,000 tons of industrial enzymes annually. China is the world's largest producer of antibiotics, glumatic acid, citric acid, vitamin C and beer. China is one of the few countries in the world that is mastering the techniques for adult somatic cell cloning of large animals. Earlier, the CII took the 5th Indian Biotech delegation to the US. Led by Dr Swati Piramal of Nicholas Piramal, the delegation had Dr Bhan and Sibal, along with industry leaders as members. The delegation went to Washington DC prior to BIO and visited many institutions including the National Institute of Health (NIH), George Washington University Law School, the US Patent Office, and the Center for Innovative Technology-Commonwealth of Virginia. A CII spokesperson said the visits were organized primarily to understand the best practices of these organizations and explore the possibilities of partnership and joint ventures between Indian companies and the US. Overall, it was yet another fruitful year for Indian biotech leader. The delegation also attended the dinner hosted by PAN IIT and CII Indian American Council. The mission was very well received in the US which reflects the growing visibility of India on the global biotech scene and also shows that the companies from across the world are keen to do business and research with India, considering its strength, added the CII official. Narayanan Suresh in Chicago ]]> <![CDATA[Vishnu Varshney bags APVCA 2006 Inaugural Award]]> https://biospectrumindia.com/news/95/2120/vishnu-varshney-bags-apvca-2006-inaugural-award.html https://biospectrumindia.com/news/95/2120/vishnu-varshney-bags-apvca-2006-inaugural-award.html Tue, 11 Apr 2006 17:35:00 +0530 Vishnu Varshney bags APVCA 2006 Inaugural Award Vishnu Varshney bags APVCA 2006 Inaugural Award The Asia Pacific Venture Capital & Private Equity Association, an alliance of Asia-Pacific Venture Capital associations (APVCA) has honored Vishnu Varshney, CEO, Gujarat Venture Finance Limited (GVFL) with the APVCA 2006 Inaugural Award in recognition of his outstanding contribution to the venture capital and private equity industry in Asia and his longstanding service to GVFL. He is the first recipient of the award and the only venture capitalist in India to receive this honor. "Vishnu has been one of the earliest VCs in the country when the term was less known and has done a tremendous amount to encourage small entrepreneurs and industry. The industry was barely $100 million when Vishnu became a VC and today it is over $ 2 billion, " said Saurabh Srivastava, chairman, IVCA. "After a lull, the venture capital industry in India is seeing a resurgence, with about $2.3 billion being invested in Indian companies across 147 deals during 2005. New age entrepreneurs are getting opportunities to work in innovative and niche areas with immense potential. The APVCA award is an acknowledgement of the work and results that GVFL has achieved in nurturing enterprises across India, " said Vishnu Varshney, CEO, GVFL Ltd. Kiran Mazumdar-Shaw voted "most influential" in Bio-Business Dr Kiran Mazumdar-Shaw, chairman and managing director, Biocon was voted as "most influential" in Bio-Business (outside the US and Europe) in a poll conducted by the international journal Nature Biotechnology. "I consider this international acknowledgement as recognition of the potential and promise that Biotechnology holds for our country and I accept this on behalf of the entire Indian biotech community," Kiran Mazumdar-Shaw said. Last year Dr Shaw made it to the Fortune's list of the 50 most powerful women in international business. A recent survey by a leading Indian business magazine declared her as one of the most powerful women in Indian business. Nature Biotechnology noted, "Curiously, the winner of the 'Bio-business in the rest of the world' category, Biocon's CEO Kiran Mazumdar-Shaw, seems to be more popular on the global scene than she actually is at home." In January, Nature Biotechnology's e-mail registrant list and website visitors were asked to vote for the people they viewed as most influential in eight different categories of biotech. The poll, posted online from January 12 to 31, 2006, included 291 nominees, short-listed by the editors of Nature Biotechnology. Dr Kaiser Jamil elected President of TWOWS Dr (Smt.) Kaiser Jamil, emeritus scientist and head, genetics department, Bhagvan Mahavir Medical Research Centre, Hyderabad has been elected president of Third World Organization for Women in Science, Italy. She has also been given the additional responsibility of heading the research division of Indo-American Cancer Hospital and Research Centre. A recipient of many awards, Dr Jamil was formerly an active scientist at the Indian Institute of Chemical Technology (IICT), Hyderabad. Melvin Oscar D'Souza is new MD of Novo Nordisk India Melvin Oscar D'Souza has been appointed as the managing director of Novo Nordisk India. Prior to this, he held the post of Sales and Marketing Manager, Novo Nordisk Pharma Gulf FZ-LLC, International operations, Regions of North Africa and Gulf, Saudi Arabia and Gulf. Dr Asha A Juwarkar bags Pitambar Pant National Environmental Fellowship Award Dr Asha A Juwarkar, deputy director, environmental biotechnology division, bagged the prestigious Pitambar Pant National Environmental Fellowship for 2003, of the Ministry of Environment and Forests (MoEF), Government of India. The award is in recognition of her contribution to the field of environmental biotechnology and for undertaking research on "Phytoremediation and Bioutilization of Industrial wastes". Awards galore at DBT Foundation Day function The foundation day function of the Department of Biotechnology (DBT) was held on March 13, 2006. On the occasion, awards in various categories were given to recognize the outstanding contribution of scientists in the field of biology and biotechnology. The National Award for Senior Women BioScientist for the year 2005 was conferred on Dr A Radha Rama Devi of the Centre for DNA Fingerprinting and Diagnostics (CDFD), Hyderabad, for her lifetime contributions and excellent research on in-born errors of metabolism and genetics. She has established the genetic diagnostic center at CDFD and has devised a cost effective validated method to test for mental retardation and disability in India. The award carries Rs one lakh along with a citation and a gold medal. The National Award for Women BioScientist under the young category for the year 2005 was conferred on Dr Suparna Sengupta, at the Rajiv Gandhi Centre for Biotechnology, Thiruvananthapuram and Dr Kusum Arunachalam at the North Eastern Regional Institute of Science and Technology, Nirjuli. The award carries Rs 50,000 along with a citation and a gold medal. Dr Sengupta has made important contributions in the area of anti-cancer agents while Dr Arunachalam has worked extensively on characterization of ecosystem dynamics of wetlands, forest and agricultural systems. To recognize the efforts of the young scientists in basic and applied research covering all the areas of biosciences and biotechnology, the National BioScience Awards for Career Development had been instituted by the Department. Each award carries a cash prize of Rs one lakh, a research grant of Rs three lakh per year for a period of three years and a citation. During 2005-06, six awards were given in this category. The awardees are: Dr Apurva Sarin, reader, National Centre for Biological Sciences, Bangalore for her outstanding contribution in unraveling the mechanism of apoptosis in T lymphocytes of mammalian origin Dr Dulal Panda, associate professor, School of Biosciences and Bioengineering at IIT, Mumbai for his pioneering work in understanding the molecular mechanism of regulation of microtubule assembly dynamics and mechanism of action of microtubule targeted anticancer drugs Dr GPS Raghav, scientist, Institute of Microbial Technology (IMTECH) Chandigarh for his significant contribution in the area of bioinformatics and computational biology Dr Rajinder Prasad Roy, National Institute of Immunology, New Delhi for his excellent research towards understanding the basic mechanism of protease mediated peptide ligation, which is potentially useful in synthetic design strategies Dr Saumitra Das, assistant professor at the Indian Institute of Science, Bangalore for successfully demonstrating that the ribosome assembly on hepatitis C virus RNA can be effectively targeted on two different steps by using either a small RNA or a synthetic peptide which can be tried in combination as a multi drug approach Dr Sundip Chattopadhyay, scientist, National Centre for Genome Research, New Delhi, for his significant contribution in unraveling the role of transcription factors in light mediated signal transduction pathways controlling seedling development in plants. The DBT had instituted the Innovative Young Biotechnologist Award in 2005 to identify and nurture young exceptional scientists with innovative ideas who are desirous of pursuing research in frontier areas of biotechnology. The awardees include Dr Amita Gupta, University of Delhi (South Campus), New Delhi; Dr Samir V Sawant, NBRI, Lucknow; Dr D Sundar, Pondicherry University, Pondicherry and Dr Gitanjali Yadav, NII, New Delhi. In order to encourage students for higher studies in life sciences, the Department awarded 25 biology scholarships to top students in biology at CBSE 10+2 level examination. Each scholarship carries a cash amount of Rs 15,000, a gold plated medal and a certificate of merit. Shri Aravindhan receives ISCA Young Scientist Award-2006 for Environmental Sciences Shri Aravindhan, SRF at the Central Leather Research Institute (CLRI), Chennai, has been awarded the Indian Science Congress Association Young Scientist Award 2006 for his outstanding contributions to the area of Environmental Sciences at the 93rd Indian Science Congress held at Hyderabad. Shri Arvindham, M Tech in Leather Technology, is presently working towards his PhD which deals with removal of dyes and chromium from tannery waste water using low cost absorbents. He has been conferred this award for his work on removal of dyes from waste water using a novel zeolite-based catalyst. NEERI-GVAK research paper bags first prize in biotech cancer A research paper jointly submitted by the National Environmental Engineering Research Institute (NEERI) Nagpur and Go-Vigyan Anusandhan Kendra on the effectiveness of Gomutra in cancer treatment bagged first prize in biotech cancer, an event organized by Hislap College of Biotechnology. The paper discusses in detail how Gomutra acts as a catalyst in triggering destruction of the cancerous cells through Apoptosis. A patent application has been filed for international patent for the treatment method. ]]> <![CDATA[Ocimum Biosolutions wins IT Innovation in India 2005 Award]]> https://biospectrumindia.com/news/95/1779/ocimum-biosolutions-wins-it-innovation-in-india-2005-award.html https://biospectrumindia.com/news/95/1779/ocimum-biosolutions-wins-it-innovation-in-india-2005-award.html Tue, 11 Apr 2006 17:31:00 +0530 Ocimum Biosolutions wins IT Innovation in India 2005 Award Ocimum Biosolutions wins IT Innovation in India 2005 Award Ocimum Biosolutions, a Hyderabad-based life sciences R&D enabling company has won the NASSCOM IT Innovation in India 2005 Award. This award aims at encouraging and fostering a culture of creativity and innovation in the Indian IT industry. Ocimum Biosolutions was shortlisted from among 150 companies across India. Anuradha Acharya, founder and CEO of Ocimum Biosolutions, received the award from the President of India, Dr APJ Abdul Kalam at the NASSCOM 2006 - India Leadership Forum held in Mumbai recently. The IT Innovation in India award is a premier honor for Indian IT companies which have infused innovation into their existing know-how and have come up with new ideas, products, processes or technologies to enable the business achieve higher margins, and thus, profits, to re-invest in the business. On winning this award, Anuradha Acharya said, "Ocimum Biosolutions has been a pioneer in creating an environment for innovation in the field of genomics and bioinformatics. This recognition by NASSCOM means a lot to us and will help us create more enthusiasm to build innovative products out of India."   BV Biologicals, DeLaval to market mastitis prevention products BV Biologicals, a group company of Venkateshwara Hatcheries specialized in the manufacture and marketing of biotech products engineered to suit the large animal health sector mainly cattle, sheep and goat has entered into a joint venture with DeLaval for marketing mastitis prevention products. A memorandum of understanding (MOU) was signed by OP Singh, CEO, Venkateshwara Group and Hemant Ogale, managing director of DeLaval. Mastitis is a dreaded disease affecting dairy animals. It is responsible for colossal economic losses (Rs 6,053 crore annually) to the dairy industry, since it drastically alters the physical and chemical characteristics of milk, there by rendering it poorer in quality. BV Biologicals will operate and supply the products to all customer segments in India across territories with direct and indirect sales approaches. DeLaval will provide technical support to BV Biologicals for products such as Dipal, Dip Cup, California Mastitis Test Kit and California Mastitis Test Reagent. Commenting on the joint venture, OP Singh said, "We believe the JV with DeLaval will help our companies to expand our services and facilitate dairy farmers get more business through the production of quality and clean milk." Hemant Ogale, managing director, DeLaval India, said, "Our mission is to drive progress in milk production. Together with our partners, we would like to strengthen our presence in the market and cater to the needs of milk producers and to make clean milk production a way of life."   Indian Immunologicals pitches into Pakistan market Indian Immunologicals Limited (IIL), a leading vaccine manufacturer in India having good presence in international market, has entered the Pakistan market with its human and animal vaccines by signing a Memorandum of Understanding (MoU) with Cirin Pharmaceuticals (CPPL), Rawalpindi and AIMS Traders, Lahore. As per the agreement CPPL will market human vaccines and AIMS Traders will market animal vaccines in Pakistan. IIL, the first company in India having state-of-the-art facilities for the manufacture of human and animal vaccines, shortlisted CPPL and AIMS, Pakistan companies with well-established marketing network to market its products in Pakistan during BioAsia 2005 held at Hyderabad. Commenting on the agreements, K V Balasubramaniam, managing director, Indian Immunologicals Limited said, " While providing 'quality vaccines at affordable prices' to the Indian consumers, now we are looking forward to Pakistani market and confident that Pakistani consumers would also benefit immensely with these agreements." AIMS Traders is hopeful to get the registration of IIL's FMD vaccine, Raksha-Ovac in Pakistan and initiate marketing activity by mid-2006.   Claris to set up manufacturing facility for EPO Claris Lifesciences, an Ahmedabad-based pharmaceutical company will set up its own manufacturing facility to produce erythropoietin, a rDNA product by end of this year. Currently Claris is importing erythropoietin and marketing in India under the brand name Epotin. Speaking to mediapersons in Mumbai, Sushil Handa, chairman, Claris Lifesciences, said, "Although the market for EPO in India is small, it is growing at a good rate. We are now in third position in EPO market in the country. Besides focusing on local market, we are also looking at exporting biotechnology products. We have identified the markets in the developing world. Once the manufacturing facility at Ahmedabad is in place, we will submit registrations in the developing countries where we have a strong marketing network for our pharmaceutical products." Considering the market potential of biotechnology products in India, Sushil Handa said, "Claris will soon enter the biotech market with other products like G-CSF and interferons." Claris Lifesciences is also committed to research and is manifested through its Claris Research Foundation (CRF). The Foundation with a team of 190 scientists has been focusing in the area of development of innovative products and new drug delivery systems (NDDS) for management of critical illnesses. The Foundation has initiated its research program in the field of biotechnology with focus on R&D of monoclonal antibodies and recombinant technology.   3P is key to drive demand in global vaccines markets: report There is a huge unmet need in emerging markets, which can been catered to only with a focused approach, driven by support from the leading vaccine manufacturers and increased role of private-public partnerships (3P). New analysis from Frost & Sullivan on Global Vaccines Markets reveals that vaccines markets earned revenue of $ 9,925.5 million in 2005 and estimates to reach $20,019.1 million in 2012. "There is a huge shortfall in manufacturing capacity of vaccine manufacturers largely because of the deadlock between governments and vaccine manufacturers. Significant addition to manufacturing capacity is urgently needed to continue immunization programs, especially with new and better vaccines expected to be launched," noted Barath Shankar, research analyst, Frost & Sullivan. The launch of new vaccines against rotavirus and HPV expects to support the next phase of accelerated growth of the vaccines in developed markets. However, the success of these products in rest of world markets would determine the long-term growth of the vaccines market. The lack of basic healthcare infrastructure in emerging economies is a major challenge that is receiving increased attention from government and aid agencies. The emergence of private-public partnerships is expected to overcome the hurdles posed by these shortcomings. "The top five vaccine manufacturers account for 85.3 percent of vaccine revenues globally in 2005. This is due to the large share of revenues from developed markets that account for 79.5 percent of the global vaccine revenues. The emerging markets have a large untapped potential that is assisted aid agencies and public-private partnerships," said Barath Shankar.   Ranbaxy acquires Romania's largest generics company India's pharma major Ranbaxy Laboratories Limited has acquired leading Romanian pharma company Terapia for $324 million. This new entity, the largest generic company in Romania, will help Ranbaxy leverage its presence across the European Union and the CIS markets. Coming barely days after Ranbaxy's acquisition of the unbranded generic business of Allen S.p.A (a division of GlaxoSmithKline (GSK), in Italy acquired through Ranbaxy's Italian subsidiary, Ranbaxy Italia S.p.A) the deal is of significance in fast tracking Ranbaxy growth plans giving it access to another of the fast growing markets. Scheduled to join the European Union from January 1, 2007, Romania is the fastest growing pharmaceutical market in the Central & Eastern European (CEE) region recording an approximate annual growth of 34 percent from 2002 to 2005. Besides, Terapia also has a presence outside of Romania with 30 percent of its product portfolio registered in over 15 countries including the high growth generic markets of Russia, Ukraine and Poland. According to Peter Burema, president, Ranbaxy, Europe, CIS, Africa & Latin America, the latest acquisition of Ranbaxy gives the company a platform to further leverage its primary care presence across the European Union and the CIS markets. "The product portfolio of the two companies is highly complementary," he said. Slated to be on path to become one of the top five global generics company, currently Ranbaxy is among the top 10 generic pharmaceutical companies in the world and is rapidly consolidating its presence in Europe. The Terapia acquisition has created multiple synergies of product development, product flow, low cost manufacturing and proximity and access to high growth markets for the company. "Terapia represents exceptional value for our stakeholders," stated Malvinder Mohan Singh, CEO and Managing Director, Ranbaxy Laboratories Limited.   Ranbaxy enters LATAM, Russia markets with oncology products Ranbaxy Laboratories Limited (Ranbaxy), India, has entered into a strategic alliance with Zenotech Laboratories Limited (Zenotech), India. Under the semi-exclusive agreement, Ranbaxy will market Zenotech's oncology cytotoxic injectible products under the Ranbaxy label, leveraging its global marketing and distribution network, in the key markets of Latin America (LATAM), including Brazil and Mexico, Russia and other CIS markets. Ranbaxy is also exploring to expand this collaboration to other markets. Zenotech will develop and manufacture these oncology products at its dedicated facilities located in India. Commenting on the development, Peter Burema, president, Europe, Africa, CIS and Latin America, Ranbaxy, said, "We welcome this opportunity to join hands with Zenotech towards establishing a relationship that will complement each other's strengths. The alliance facilitates Ranbaxy's entry into this new therapeutic segment in these key markets. Ranbaxy will continue to strengthen its product portfolio and provide novel products for the benefit of the patients." Dr Jayaram Chigurupati, CEO, Zenotech Laboratories said, "Zenotech is very excited about the collaboration with Ranbaxy. This collaboration will enable us to expand market reach of our speciality injectables portfolio to cancer patients in several emerging markets around the world. The alliance will positively impact Zenotech in speeding up its own biogenerics development program." Zenotech is a specialty generic injectables company with a biotech core. Zenotech's predominantly high value injectables product portfolios serve niche therapy areas like oncology, anesthesiology, gynecology, and neurology. Zenotech has direct marketing presence in India and in Vietnam and has subsidiaries in Brazil and Nigeria. Zenotech's generic biologicals, GM-CSF and G-CSF have completed clinical trials in India and are awaiting regulatory approvals for market launch. Zenotech has full-fledged research and development facilities in India and in the US. Its oncology and biologics manufacturing facilities are located in India.   Cadila Healthcare gets DCGI's nod to conduct Phase II clinical trials on ZYH1 Ahmedabad-based Cadila Healthcare has received permission from the Drug Controller General of India (DCGI) to conduct Phase II clinical trials on its new molecular entity - ZYH1, after successfully completing Phase I clinical trials. The Phase II studies will focus on evaluating the efficacy of ZYH1. This novel agent for treatment of metabolic disorders has been designed and developed by Zydus Research Centre, the research wing of the company. "ZYH1 is expected to address the issue related to patients suffering from dyslipidemia in both diabetic and non-diabetic condition," said Dr BB Lohray, president, Zydus Research Centre. The drug is expected to improve lipid profile, leading to decrease in cardiovascular risk in diabetic patients, as well as other diabetes related complications. In Phase I clinical studies, the molecule showed favorable pharmacokinetics and good oral bioavailability. The drug is expected to have a once daily dosing leading to better compliance.   GlaxoSmithKline launches second phase of Suraksha Kavach program GlaxoSmithKline (GSK), India's leading vaccine company introduced the second phase of its recently launched Suraksha Kavach program with a nationwide initiative to educate school children on chickenpox. The school campaign is the second phase of the campaign that will roll out in ten cities - Delhi, Mumbai, Kolkata, Hyderabad, Bangalore, Chennai, Ahmedabad, Pune, Jaipur and Ludhiana. Interactive communication modules will help children and adolescents understand the disease, how it spreads and ways to prevent chickenpox. GSK launched the Suraksha Kavach programme on the eve of India's 57th Republic Day, and to drive awareness about protection against disease and wellness for individuals, families and society at large. Chickenpox is a highly infectious disease, caused by the Varicella zoster virus, which results in a blister-like rash, itching, tiredness and fever. GSK's initiative aims to improve disease awareness, highlight prevention method and dispel myths that still persist about chickenpox. Vaccination is the most effective, practical and convenient way of preventing chicken pox. Indian Academy of Pediatrics (IAP) immunization guidelines recommend that the chickenpox vaccine can be given at any time after one year of age.   MMB (India) reduces Bt tech fee to Rs 900 per 450gm Mahyco Monsanto Biotech (India) Ltd (MMB) has reduced the technology fee by 30 percent from Rs 1,250 per 450gm packet of Bollgard cottonseed charged to seed companies for use of its insect-protected cotton technology in order to best meet current market conditions. According to Sarita Bahl, senior manager, public affairs, Monsanto, "In the coming season, the technology fee will be Rs. 900 per 450gm packet of Bollgard cottonseed, approximately 30 percent less than last year's technology fee. This change in the technology fee will give MMB's seed company licensees an opportunity to pass along new savings to farmers if they choose. If seed companies do choose to lower their final seed prices, we believe that this will encourage more farmers to choose genuine Bollgard technology because of its clear benefits." It may be recalled that during last January the government of Andhra Pradesh has approached the Monopolies & Restrictive Trade Practices Commission (MRTPC) on high pricing of Bt cottonseed by MMB India Ltd, a 50:50 marketing JV between Mahyco and Monsanto Holdings.   Advanced Enzyme receives SKAL certification Advanced Enzyme Technologies has received SKAL certification for its EnviroSEB product being certifying it to be an organic product. With this, Advanced Enzyme Technologies has joined the SKAL International Program for Organic Certification for its agriculture product AgroSEB (Unique Biological Yield and Quality Enhancer) that originates from organic cultivate and are processed using organic methods. The team at Advanced Enzyme Technologies worked on the program for the Organic Certification, detailed the documentation and process parameters and successfully complied for the SKAL International Audit for Organic Certification and received the organic certificate for its agriculture bioproduct AgroSEB â€“ an organic bio enzyme. SKAL International is an independent, internationally operating organization that carries out inspections and issues certificate for sustainable organic production methods by supervising, testing, inspecting, assessing and certifying the organic products.   ICRISAT's ABI bags best tech incubator 2005 award The Agri-Business Incubator (ABI) at the International Crops Research Institute for the Semi-Arid Tropics (ICRISAT) has been selected by the central government to receive the National Award for the Best Technology Incubator for the year 2005. A formal announcement regarding the award is expected on May 11. The ABI has been selected on the basis of its work done in promoting technology-based ventures in the agri-biotechnology sector. "It has been proved that a strong and dynamic agri-business substantially contributes to growth in agricultural production and employment," said Dr William Dar, director general of ICRISAT. The selection of ABI at ICRISAT for the Best Technology Award is a testimonial to the institute's success in attracting public-private sector partnerships for developing agricultural technologies into successful agri-business ventures, added Dar. The ABI was established with financial support from NSTEDB. Through the ABI, the institute is promoting several technologies ranging from farm-based to advanced biotechnologies. Some of the agri-business products and technologies incubated through ABI are: sweet sorghum for ethanol production; Helicoverpa-resistant transgenic cotton and drought-resistant groundnut. ]]> <![CDATA[Safe Clinical Trials]]> https://biospectrumindia.com/news/95/2191/safe-clinical-trials.html https://biospectrumindia.com/news/95/2191/safe-clinical-trials.html Tue, 11 Apr 2006 17:29:00 +0530 Safe Clinical Trials Safe Clinical Trials Six healthy volunteers participating in the clinical trials of a bio-tech drug, developed by a German company, TeGenero in the UK last fortnight has focused global attention on the business of clinical trials. For long, these trials were done in the US and European countries. Now it is global in nature, illustrated best by these trials of the drug developed by the German company, conducted in the UK by Parexel with many of the volunteers being Asian. Somehow, clinical trials evoke strong reactions around the world. The "adverse event" that happened when the experimental molecule TGN1412 caused unexpected reaction in healthy volunteers has baffled the medical community. In due course there will be better understanding of what went wrong and corrective measures will be in place soon. Because, the pharma and health care industry has to live with clinical trials which are now an integrated part of the drug development process. Clinical data from drugs under development is a must with most of the world's regulatory agencies and an elaborate set of guidelines governing the process. Most countries where clinical trials are conducted have their own codes aligned with the international guidelines. As drug development becomes costlier by the year (the current estimate is $1 billion), clinical trials are moving to Asian countries. India and many Asian countries are making determined attempts to attract clinical trials to their boundaries as it would benefit the health care industry to learn from these experiences. Pharma companies spent nearly $40 billion in drug development in 2005 and approximately a fourth of it ($10 billion) was accounted for by the costs of conducting clinical trials. A number of third party clinical trial service providers have come into existence and the global clinical trials market is growing by an average of 13 per cent annually. According to global consultancy, IMS Health, some 2,300 drugs are undergoing trials on human volunteers around the world now. At least 212 of them are related to cancer treatments, arthritis, viral infections and cardio vascular diseases and are in advances stages of trials and would reach the patients in the next few years. India has been promoting itself as the "clinical trials hub" of the world. Almost all the major companies providing clinical trials have moved into the country and over 250 trials are now on in the country. The value of the clinical trials done in the country is estimated at $100 million and the industry estimates the figure to cross the $ 1 billion by 2010. India follows the international guidelines and all the stakeholders are working towards making the process stringent to avoid earning a bad name. Over 80 hospitals are currently equipped to conduct the trials according to global standards. A heated debate is likely to occur in many Asian countries which are opening up their markets for clinical trials over the adverse events in the UK. The debate should be welcome and the pharma industry too should treat this as an opportunity to stress the importance of clinical trials and the widespread benefits that accrue to the global community. This opportunity should also be used by the participating countries to evolve mechanisms to tighten any loopholes in the process that may let offending agencies off the hook. Countries should also evolve guidelines to clear some grey areas in the current process that allows the drug developer the discretion to make available the final product to the volunteers in the trials. Moral pressure should be strengthened with legal mechanism that the volunteers too become the first beneficiaries of any successful product launch for which they had played a key role. ]]> <![CDATA[Thermo unveils new proteomics capabilities]]> https://biospectrumindia.com/news/95/2340/thermo-unveils-new-proteomics-capabilities.html https://biospectrumindia.com/news/95/2340/thermo-unveils-new-proteomics-capabilities.html Tue, 11 Apr 2006 17:21:00 +0530 Thermo unveils new proteomics capabilities Thermo unveils new proteomics capabilities Thermo Electron Corporation unveiled several new additions to its Proteomicsn suite of solutions. These include Thermo's novel LTQ Orbitrap hybrid mass spectrometer, new techniques for peptide fragmentation and software for data interpretation, all which enhance and expand the potential for protein identification and quantification. Thermo's Proteomicsn solutions are designed to leverage the performance, speed, sensitivity and accuracy of their market-leading ion trap mass spectrometers for definitive quantitation of protein mixtures. Some of these new solutions include the LTQ Orbitrap, the first commercial mass analyzer based on an entirely new detection principle to be introduced to the market in over 20 years. This hybrid instrument improves protein characterization, accelerates protein database searches and reduces false identification rates. Thermo has also introduced new approaches to protein quantitation, such as Pulsed-Q Dissociation (PQD), a new fragmentation technique that eliminates the low mass cut-off for ion traps and allows quantitation with iTRAQ labeling reagents. iTRAQ is a stable isotope method for relative protein quantitation using mass spectrometry. For more details contact: shashin.shah@thermo.com Cambrex's Poietics Normal Peripheral Blood Leukopaks Cambrex Bio Science Walkersville has announced the availability of Poietics Normal Peripheral Blood Leukopaks. Leukopaks are bags of fresh human blood cells collected from normal peripheral blood by automated apheresis in ACD-A anticoagulant and density gradient centrifugation. Each leukopak contains a mixture of monocytes, lymphocytes, platelets, plasma and red cells. Leukopaks are useful in research for the isolation of specific cell types, the application of novel isolation methods, the comparison of different blood cell types from a single donor and other applications associated with immune and blood cell research. Each leukopak contains large quantities of cells from a single donor and is monocyte-enriched with a guaranteed minimum volume of 100 ml and a standard cell count of approximately 60 million/ml. All donors are screened for general health and test negative for HIV-1 and hepatitis B and C. Leukopaks with custom volumes or special donor characteristics can also be provided including: tetanus-boosted, cytomegalovirus-negative, diabetic, and Epstein-Barr virus donors. Mobilized peripheral blood and polymorphonuclear cells-enriched leukopaks are also available upon request. Poietics Normal Peripheral Blood Leukopaks are for research use only. For details, contact: biosales@cambrexindia.com Enertech launches dry baths Enertech Electronics, a Mumbai-based manufacturer of pumps and ultrasonic cleaning and welding machines, has launched dry baths in India. These baths are manufactured exclusively for Indian companies. It is a molecular biological tool for any lab. It is a 3-in-1 dry bath unit with mixing (shaking), chilling (freezing) and heating facility in the same unit. It uses the latest energy efficient Peltier Design. The technology ensures efficient and economical consumption of power, reliable performance, rugged system design and uniformity of temperature along with longevity of system. Dry baths also ensure that the system can be use for continuous duty, operations for long hours without any problems. It offers a very broad temperature range from 10 O C to 150 O C. Now users can mix, chill, freeze or heat and run unattended temperature. Users can choose blocks for various types of micro centrifuge tubes, PCR plates/ strips, flat bottom and various types of test tubes. Solid blocks are available for machining. All the above blocks are interchangeable blocks. The systems have RS 232/ RS 485 interface for computer connectivity. It also has 30-day countdown timer with alarm and auto/ off. It has inbuilt memory to store various programs for precisely timed and repeatable routines. This is available at economical prices. For details, contact: info@enertechindia.com or dhanesh_537@rediffmail.com Waters introduces ACQUITY SQD Waters Corporation has introduced a new ultra performance liquid chromatography/mass spectrometry (UPLC/MS) system called ACQUITY SQD. It gives scientists more information about the identity of pharmaceutical, biological, industrial and environmental compounds than conventional UV/Vis-based detector systems. LC/MS systems equipped with single quadrupole mass detectors have become increasingly popular for high-throughput LC/MS work in drug discovery and development laboratories due to the capability, affordability, usability and small footprint of the mass detector. This UPLC/MS system features the new Waters SQ Detector - a benchtop, ultra-compact, single-quadrupole, atmospheric pressure ionization (API) mass detector designed for routine UPLC/MS analyses. With first-of-its-kind IntelliStart Diagnostic Software, the ACQUITY SQD tunes and calibrates the mass detector and conducts system performance checks allowing chromatographers to confidently acquire UPLC/MS data in routine analytical and open access applications. Waters ACQUITY SQD applications include peak purity/impurity profiling, synthesis confirmation, product deformulation, and enhanced methods development through the use of molecular weight-based peak tracking. For details, contact: Padmini_Satish@waters.com or Water_India@waters.com ]]> <![CDATA[Dengue-resistant mosquito developed]]> https://biospectrumindia.com/news/95/1292/dengue-resistant-mosquito-developed.html https://biospectrumindia.com/news/95/1292/dengue-resistant-mosquito-developed.html Tue, 11 Apr 2006 17:17:00 +0530 Dengue Dengue-resistant mosquito developed Researchers have successfully created a genetically engineered mosquito that shows a high level of resistance against the most prevalent type of dengue fever virus, providing a powerful weapon against a disease that infects 50 million people each year. Anthony James, a University of California Irvine vector biologist, is one of a team of researchers who injected DNA into mosquito embryos, creating the first stable transgenic mosquito resistant to Type 2 dengue fever virus, the most prevalent strain of the disease. The mosquitoes that survived the procedure also remained fertile and were able to reproduce, a key factor for any future strategies that may involve replacing mosquito populations with their genetically modified counterparts. In the study, the researchers exploited a vulnerability of the dengue virus to make the mosquitoes resistant to infection. This vulnerability occurs when the virus replicates and its single strand of RNA â€“ a chemical cousin of DNA â€“ briefly becomes doubleâ€“stranded. At this point, the virus is vulnerable because of a naturally occurring protein called dicer-2. This protein initially has no effect on a single strand of RNA, but acts like scissors on the double strand, chopping it up and rendering its genetic material useless. Once this process is started, the single-stranded RNA also becomes vulnerable to dicer-2 and is cut up, thereby preventing further virus replication. On its own, this process of self-destruction happens only after the virus has already replicated and been transmitted; however, the researchers found a way to control and speed up the process. They accomplished this by cloning a section of the virus' RNA and injected two inverse copies of it into mosquito embryos. The copies formed a double-stranded RNA, which, as expected, bound with dicer-2 and was chopped up. The virus never had the opportunity to replicate. As a result, they could "inoculate" mosquitoes with a form of the virus that would essentially be benign. James and his colleagues performed tests on a family of mosquitoes descended from one of the original embryos that survived the procedure. They found that the vast majority of that family was highly resistant to dengue infection. They also were able to detect the engineered RNA in the mosquitoes, a sign that the genetic alteration had been successful and passed down through reproduction. Furthermore, when that genetic modification was reversed, the mosquitoes were as susceptible to the virus as they had been before the procedure. Dengue fever is endemic in more than 100 countries in Africa, the Americas, the Eastern Mediterranean, Southeast Asia and the Western Pacific. The virus is transmitted to people by mosquitoes of the species Aedes aegypti. The WHO estimates 50 million cases of dengue infection each year. Approximately 20,000 people die annually from the disease. According to James, the next step of this research will be to explore population replacement strategies using the genetically modified mosquitoes. He stressed that no genetically altered mosquitoes will be released at any time during these studies. Source: University of California - Irvine   ]]> <![CDATA["Pharmaceutical industry in Asia Pacific region is booming"]]> https://biospectrumindia.com/news/95/7608/pharmaceutical-industry-in-asia-pacific-region-is-booming.html https://biospectrumindia.com/news/95/7608/pharmaceutical-industry-in-asia-pacific-region-is-booming.html Tue, 11 Apr 2006 17:06:00 +0530 New Page 1 "Pharmaceutical industry in Asia Pacific region is booming" Robert Solazzo, business/sales development manager, pharmaceutical solutions, Asia Pacific Life Sciences and Chemical Analysis group, Agilent Technologies How do you see the pharmaceutical solutions arena developing/evolving in the coming years? What are the current trends? The pharmaceutical industry is currently under significant pressure to reduce overall costs as well as to ensure regulatory compliance and drug safety. This trend is worldwide. They are looking at increased productivity from the laboratory and to this end, reduced cost per analysis while still maintaining compliance with regulatory requirements. What kind of growth/market do you currently see in this segment in different countries/regions? How is India in particular and the Asia Pacific region in general placed? The pharmaceutical industry in the Asia Pacific region is booming, especially in China and India. There is significant investment from foreign pharmaceutical companies throughout the region and domestic manufacturers are also going through an expansion phase to keep pace with increased demand. India is well positioned to take advantage of increased demand in affordable medicines and the growth in the domestic industry is already very well documented. India has a strong core competency in producing high quality and affordable medicines as well as active pharmaceutical ingredients to supply overseas markets. How do the new Liquid Chromatography series (1200 and 6000) further facilitate analysis? What are some of their salient features? The 1200 Series LC and 6000 Series LCMS are designed for reliability, robust operation and low cost of ownership while maximizing overall performance for confidence in the data generated by these platforms. The 1200 LC builds on the performance of the 1100 Series that sold over 60000 systems worldwide. The 1200 is fully compatible with the 1100 while offering superior performance in terms of speed and resolution. The new 1200 Series Rapid Resolution System provides up to 20 times faster analysis and 60 percent higher resolution than conventional LC, making it twice as fast and three times as precise as the competition's best systems. The system can also still run any traditional LC method, making it the most flexible LC on the market. Further, a special high-throughput configuration of the 1200 Rapid Resolution system allows sequential execution of more than 2,000 samples per day on a single system - without giving up data quality or method flexibility. The Push for Help function is unique in the industry. With a click of a mouse, instrument configuration details, recent logbook, and user contact information are accurately transmitted over a secure connection to an Agilent customer support center for immediate attention. The system is designed for maximum sample throughput, highest possible uptime and best performance while still being able to maintain regulatory compliance. The LCMS platform has been designed for usability and performance, making it accessible to a wider range of potential users. This is achieved with the follow key, three design features: Agilent's proprietary autotunetechnology Agilent's autotune technology automatically calibrates the instrument with the click of the mouse, optimizing for sensitivity and mass accuracy. It has the potential to repeatedly save customers hours of tedious work or delay. Compatibility with Agilent's multimode source and HPLC-Chiptechnology All Agilent 6000 Series mass spectrometers will be compatible with the Agilent multi-mode ion source, the first and only technology capable of simultaneously operating electrospray ionization (ESI) and atmospheric pressure chemical ionization (APCI), saving repetition of experiments; and the Agilent HPLC-Chip/MS system, which replaces traditional columns with a credit-card-sized chip that eliminates 50 percent of the fittings and connections typically required in an LC/MS system, significantly simplifying workflow and increasing sensitivity and reliability. There is integrated LC and MS software for instrument control and data analysis. Each instrument comes with integrated LC and MS software for a single point of instrument control and data analysis. In conjunction with these products, Agilent is introducing a range of application-specific software programs that allow researchers to quickly get answers to the real problems they are trying to solve. All use the most modern, industry-standard development tools and a new ".Net"-based MS data processing environment. Rolly Dureha ]]> <![CDATA["India ahead of China in regulatory aspects"]]> https://biospectrumindia.com/news/95/1298/india-ahead-of-china-in-regulatory-aspects.html https://biospectrumindia.com/news/95/1298/india-ahead-of-china-in-regulatory-aspects.html Tue, 11 Apr 2006 17:04:00 +0530 New Page 1 "India ahead of China in regulatory aspects" Robert A Honor, vice president - life sciences, Rockwell Automation Which is an emerging market in the Asia Pacific region for your range of products? In the Asia Pacific region, India and China are clearly putting in a lot of efforts in pharmaceuticals and biotechnology sectors. They are definitely the driving markets for life sciences. As the population becomes more economically variable, health care in general is going to become a greater part of the economy. So the demand for drugs and medicines will continue to grow and India and China will lead the way. We are investing in Singapore and recently invested in Australia. We continue to see opportunity in Japan, although it is a matured market. So we see a lot of opportunities in the Asia Pacific region. However, I put India a little ahead of China mainly because of regulatory aspects, for having more US FDA audited facilities outside the US in the world. How you see the opportunity in India where the pharma, biotech and life sciences industries are growing at a faster rate? We see great opportunity for our range of products in India owing to a couple of factors. First, the growth of the industry by itself will provide a great opportunity. Second, the export nature. India has the most FDA audited manufacturing plants outside the US in the world. A lot of our products and services will build Indian capabilities to meet the process requirements of the global standards so as to go to the international market. The regulatory aspect is one factor and then the overall growth of the industry and investments that is the need of the industry itself makes us to look at India. Of your many products like Process Analytical Technology, RFID, manufacturing execution system (MES), computer system validation, Original Equipment Manufacturer (OEM) compliance program, which do you feel has more market potential as far as India is concerned? In India our focus is on two areas. The first one is OEMs. It provides great development environment, automate and improve their individual skills. The second one for drug manufacturers or process control capabilities for MES, again built on the same platform of integrated architecture but our abilities is to control processes and improve processes to meet the regulatory promises. We feel these are the two biggest opportunities in India. I don't want to exclude several other areas that we find very attractive and these include automation, facilities control, providing utilities like clean water, steam, power from motors and motion controls, special packaging and material handling, mixing and blending. But we tend to focus on OEMs and MES. IT companies are focusing on Radio Frequency Identification (RFID). Since Rockwell too has products in this space, how do you look at market opportunity for RFID? Globally, we see a lot of ideas and great potential for almost all the manufacturing businesses in the world. The pharma and biotech sectors in particular have unique requirements as have they to comply with the regulatory aspects. And BioIT can ease the requirements in terms of meeting the regulatory aspects specified by variousgovernments. Hence, we see great opportunity for RFID. We also see opportunity into the whole supply chain. This can be best extended to what has already been done in manufacturing in terms of better control, optimized control and extend that throughout to complete the supply chain for all manufacturers. We have been working with IT for more than 20 years now and have a lot of experience in applying IT technologies. And this a great opportunity for pharmaceutical and biotech sectors. Do you see any competition from IT companies as far as RFID is concerned? We see them as complementary to each other (the IT companies). We do know what is going on in factory floor. We provide great links. For factory floor information, using our IT technologies into the business systems where the IT companies have a role to play. We feel they are our partners. The IT companies can improve and implement business systems. We can improve and implement with the real time control systems. We have the advantage of being able to tie real time data into business systems through our integrated architecture. We have many specific tie-ups with Indian IT companies but they are our customers. Narayan Kulkarni ]]> <![CDATA[BIO favors cellulosic ethanol production to end US addiction to oil]]> https://biospectrumindia.com/news/95/2826/bio-favors-cellulosic-ethanol-production-to-end-us-addiction-to-oil.html https://biospectrumindia.com/news/95/2826/bio-favors-cellulosic-ethanol-production-to-end-us-addiction-to-oil.html Tue, 11 Apr 2006 17:01:00 +0530 BIO favors cellulosic ethanol production to end US addiction to oil BIO favors cellulosic ethanol production to end US addiction to oil "Industrial biotechnology is causing a dramatic paradigm shift in transportation fuels that will end our national addiction to oil. We need to rapidly move forward commercializing these technologies for cellulosic ethanol production, which will strengthen our energy and national security. Congress can improve our energy independence by acting decisively to provide the funding and loan guarantees authorized in last year's energy bill, speeding up the delivery of this vital fuel to the pumps so consumers can begin using it," said Jim Greenwood, president and CEO, Biotechnology Industry Organization (BIO). Greenwood made his remarks at a panel of experts and industry representatives convened at Washington on March 13, 2006. This panel described the industrial biotechnology processes that make possible large-scale, inexpensive production of cellulosic ethanol from crop waste and switch grass. BIO released a letter to Congressional appropriators requesting full funding for programs authorized in the Energy Policy Act of 2005 that would support research and development into advanced cellulosic ethanol production, support private investment in modern biorefinery construction, and provide loan guarantees and market incentives for rapid adoption of cellulosic ethanol motor fuel. Cellulosic ethanol could replace much of the imported oil in America's domestic transportation fuel supply. President Bush has announced his intention to make this new kind of ethanol practical and competitive. Source: www.bio.org NZBio honors biotechnologists with awards New Zealand's biotech community has recognized two of its high achievers, Robert Webster and Adrian Cookson by awarding with the 2006 NZBio Distinguished and Emerging Biotechnologist of the Year Award respectively. Robert Webster has received the Award, for his work in virology and particularly avian influenza (bird flu). Currently working for St Jude's Children's Research Hospital in Tennessee, USA, Dr Webster was born in New Zealand and obtained his degree in microbiology from Otago University. He is considered the world leader in avian influenza virus research. Dr Webster's most significant work was the discovery that all influenza viruses originated in aquatic birds, and he has been involved in studying recent bird flu outbreaks on chicken farms in Hong Kong and their spread to humans. He is also the head of the World Health Organisation (WHO) collaborating laboratory on animal influenza. Adrian Cookson, the winner of the 2006 NZBio Emerging Biotechnologist of the Year Award is now based at AgResearch's Grasslands Research Centre in Palmerston North. Born in Surrey, he received an Honours Degree in Microbiology from the University of Manchester. At Grasslands, Dr Cookson leads the Alternative Antimicrobial program, which aims to discover novel molecules that are effective in treating animal or human disease. Source: www.nzbio.org.nz Novo Nordisk opens facility in China Denmark-based pharma major Novo Nordisk inaugurated a major expansion of its production facilities in Tianjin, China. The Tianjin plant has been designated Novo Nordisk's primary production base in the Asia Pacific region and will supply both China and export markets. The expansion includes a new assembly plant for Novo Nordisk's NovoPen 3 insulin pen as well as an expansion of current packaging facilities for Penfill insulin cartridges and FlexPen prefilled insulin pens. "Our expansion in China reflects the internationalisation of our production base and our commitment to the Chinese market. The new plant is yet another example of the increasingly important role China is playing in Novo Nordisk's global operations, and we will continue to build the Tianjin plant into a world-class insulin production base," says KÃ¥re Schultz, Chief Operating Officer of Novo Nordisk. To celebrate the completion of the new plant, Novo Nordisk held a grand opening ceremony with representatives from among others the Chinese Ministry of Health, officials from Tianjin Municipal Government, the Danish embassy in China and leading diabetologists from China. "The new plant will create more than 100 new jobs in China, and will help meet the increasing demand for Novo Nordisk's insulin products in Asia and other countries. With the new plant and our R&D centre in Beijing, Novo Nordisk now has a strong platform for future growth in China," says Ronald Frank Christie, president of Novo Nordisk China. Novo Nordisk's first plant in Tianjin was built in 2002, and the new plant has been built on the existing 40,000 square metre site. With the opening of the new plant, the production of NovoPen 3 in Denmark will be phased out. The Danish plant has been re-equipped, and employees are being transferred to the production of NovoPen 4, the latest version of Novo Nordisk's durable insulin pen system. Today, almost three and a half million people worldwide use a NovoPen system for their daily insulin injections, and NovoPen 3, which was launched in 1992, is the highest-selling insulin pen in the world.   ]]> <![CDATA[India can become significant global player by 2010]]> https://biospectrumindia.com/news/95/1243/india-can-become-significant-global-player-by-2010.html https://biospectrumindia.com/news/95/1243/india-can-become-significant-global-player-by-2010.html Tue, 11 Apr 2006 16:52:00 +0530 India can become significant global player by 2010 India can become significant global player by 2010 India can be counted as a leader in cutting edge research in genetic engineering, immunological techniques, cell culture methods, stem cells and hybridoma technology. Utkarsh Palnitkar, Director, Life Sciences Ernst & Young India The global biotechnology industry is pegged at $54 billion and is growing currently at 17 percent annually. This is a clear indicator of the huge potential which the industry promises. In contrast, India's biotechnology industry is worth only $1.1 billion which constitutes around 2 percent of the global revenues. However, the encouraging factor is that the Indian biotechnology market is growing at a scorching pace of 36.5 percent per annum which is one of the highest in the world today. India would be considered a significant player on the global arena should it capture at least 10 percent of the market by 2010. India, which ranks among the top 10 biotech hubs of the world, would join the elite club of top 5 biotech hubs, should it achieve the $5 billion mark by 2010. Emerging segments The global bio-pharma industry is witnessing maximum growth in segments such as targeted therapy (antibodies, vaccines), theranostics (molecular/gene based diagnostics that determine therapies) and clinical development services (Phase I-IV human trials). India is already in a pivotal position to secure a significant share in important segments such as vaccines, diagnostics and clinical trials. For instance, it is considered that India already has the largest vaccine production capacity in the world. By 2010, India could open new frontiers by developing the globally fast growing segments facilitated by the capabilities developed indigenously. India would be in an enviable position globally if it were to meet expectations of becoming the clinical trials hub of the world. Even if 15 percent of all clinical trials were to be outsourced in the next 3 years and predictions made by BCC Research come true, $4 billion worth of clinical trials will be conducted in developing countries. (Source: Economic Times, Nov 2004) and a large part of this opportunity can be secured by the Indian biotech industry. It is estimated that India can secure around $250-300 million of the global clinical trials market by 2010. (Source: Center Watch, Aug 2003). Innovative products India can become a global leader by 2010 by leveraging on its established pharmaceutical industry and developing innovative biopharma products. This is further encouraged by India's commitment to the product patent regime which is now aligned with the global IPR system. This eventually can be possible should India enable biotech innovation in areas such as diagnostics, recombinant biotherapeutics, stem cell biology, bioinformatics, proteomics and genomics. Considering the growth rate to be constant at around 30 percent, the biopharma segment has the potential to reach an estimated value of $3 billion by 2010. (Source: Ernst & Young) Time to market In the biotechnology business, time is of more essence than the cost in which case should India be able to minimize the go-to-market time for products it will have attained a sustainable competitive advantage globally. Regulatory issues Till 2005 India only recognized process patents. However, in 2005 India committed to the product patents regime aligning its IPR system to global standards. Although this is a major step in a direction to achieve recognition of its IPR system globally, large MNCs continue to be apprehensive about the IP protection in India. Hence the industry is primarily led by entrepreneurial leadership (Biocon), fragmented research and government support. If India needs to attract foreign investment and in the larger scope become a center of cutting edge technology and product development, a strong product patent regime and its implementation is imperative. Seed funding Due to a lack of valuation benchmarks available in the biotech industry, the venture capitalists are deterred from investing in seed capital. In fact it is lack of awareness amongst financial institutions and VCs and not so much the risk involved that keeps the seed funding for biotech companies at bay. Synergy between stakeholders Most of the quality research which takes place in India in the biotech sector is conducted in government institutions such as CSIR, ICAR and ICMR. Some of the most successful products (vaccines) launched in India have been the result of successful collaboration between private players and the government. In addition there exists a clear gap between the industry and academia. The educational curriculum currently lacks in terms of industry-oriented research while the resource skill differ from those required by the industry. Attractiveness of Indian market The large global biotech MNCs such as Genentech, Amgen do not find the Indian market feasible in terms of value. The prime reason for this is that the innovative drug costs are too expensive for local consumption since the patient in India mostly pays from his own pocket and does not receive support from reimbursements by the government. Strategy to surmount challenges India would evolve the growing partnership between the pharmaceutical and biotechnology industries to create complimentary capabilities in terms of research, products, marketing and manufacturing. The government support in terms of financial and resource incentives can facilitate implementation of this strategy. Such optimal alliances will allow the pharmaceutical companies to enhance their drying pipelines and the biotech companies to secure financial muscle to sustain efforts towards developing innovative products. Further, this will also enable companies to reduce time to markets via the established foothold of our pharmaceutical companies across the globe. This is likely to become Indian biotech industry's successful business model going ahead. The second most important strategy is to nurture the industry in terms of attracting investments, promoting research and supporting entrepreneurship in the emerging areas. The large MNCs can be attracted by strengthening India's patents regime and ensuring enforcement of the same to send a clear signal to the world of India's commitment to honoring global standards of IP. India has already formulated its first National Biotechnology Development Strategy which outlines the importance of industry oriented research. The skilled human resources must be developed in accordance with the requirements of the industry and hence the educational curriculum needs to be amended accordingly. Further, entrepreneurs should be supported by establishing funds, incubators and biotech parks so that innovative ideas are not lost due to a lack of resources. Cutting edge research in globally emerging segments (such as contract bio-manufacturing services, clinical development services etc) and developing in-house capability to manufacture innovative biopharma products for these segments, will provide India with a sustainable competitive advantage for a long time to come. India can be counted as a leader in cutting edge research in areas such as genetic engineering, immunological techniques, cell culture methods, stem cells and hybridoma technology. Each of these areas will open up new frontiers in terms of developing more effective products more efficiently and hence has the potential to make India the center of excellence for research and product development. Great potential In context of the size and growth of the current Indian biotechnology market vis-Ã -vis the Asian and global markets, it is clear that India promises great potential to become one of the most significant players on the global arena by 2010. However, the various challenges need to be surmounted to achieve the vision 2010 and this can be made possible by implementing the broad strategies at the earliest. With a steadily growing prominence in the global biotechnology market, India will be all set to transform into a global leader by 2010 should it continue to unravel opportunities in the right segments and develop long term capabilities to harness the same. FDA blueprint for modernizing medical product development FDA has released Critical Path Opportunities List, an initial list of priority research projects that could advance innovation in medical products. The announcement of this List signals the next major step in FDA's Critical Path Initiative, aimed at modernizing medical product development to bring new medical discoveries to patients at a lower cost. The Opportunities List outlines an initial 76 projects to bridge the gap between the quick pace of new biomedical discoveries and the slower pace at which those discoveries are currently developed into therapies. The release of the list marks a starting point in identifying priorities to be accomplished under the Critical Path Initiative. Government, industry and academic experts estimate that, if accomplished, the new tests and tools developed under the Critical Path Initiative will modernize the drug development process by 2010 and help to get new medical discoveries to patients faster and at a lower cost. The Critical Path Opportunities List, the first specific blueprint for this nationwide modernization initiative, was developed based on feedback to the agency's 2004 Critical Path Report. The report diagnosed a slowdown in the development of innovative medical therapies, and proposed an FDA-sponsored long-term initiative to address the problem. The research projects in the Opportunities List, designed to deliver smarter tools to evaluate candidate medical products, were identified through numerous sources.The Critical Path Opportunities Report is organized into six broad topic areas: development of biomarkers, clinical trial designs, bioinformatics, manufacturing, public health needs and pediatrics. ]]> <![CDATA["Govt should encourage VCs for seed capital investments"]]> https://biospectrumindia.com/news/95/2006/govt-should-encourage-vcs-for-seed-capital-investments.html https://biospectrumindia.com/news/95/2006/govt-should-encourage-vcs-for-seed-capital-investments.html Tue, 11 Apr 2006 16:50:00 +0530 New Page 1 "Govt should encourage VCs for seed capital investments" Vishnu Varshney, CEO, GVFL The Gujarat Venture Finance Ltd (GVFL) received the initial funding of Rs 5 crore in January 2006 from the Gujarat government for a 12-year close-ended Rs 50-crore fund to boost biotech in Gujarat and also received a fund commitment from Zydus Cadila. Vishnu Varshney, CEO, GVFL and ex-chairman of India Venture Capital Association (IVCA), who recently bagged the Asia Pacific Venture Capital Association 2006 inaugural award for his contribution to the venture capital and private equity industry in Asia, spoke to BioSpectrum about GVFL's biotech fund and investments. The Gujarat government had announced the setting up of a biotech fund in 2005 itself but it became operational only in January 2006. Why the delay? GVFL had announced the setting up of the Rs 50-crore biotech fund subject to the receipt of initial seed capital of Rs 5 crore from the government of Gujarat. Now that we have received the fund from the government and have also got commitments from private corporates and banks, we looking forward to making investments in biotech companies and consolidate our fund-raising efforts. During the previous interview with BioSpectrum in April last, you had mentioned that GVFL had already received 5-6 good proposals. What is the present status of these proposals? As per the regulations, the fund is required to have a minimum corpus of Rs 5 crore before starting any venture capital activity. GVFL had received a few good proposals since the announcement of the biotech fund but we were waiting for the initial commitment from the government to conduct due diligence on the proposals. Currently there are about 7 proposals in the pipeline which we are reviewing and would soon be announcing investments under the biotech fund. How many new proposals has the GVFL received in general and from Gujarat in particular for funds? GVFL has received more than 10 proposals mostly from Gujarat-based companies. What are the processes involved in finalizing a proposal? How much time will the GVFL take to clear/defer a proposal? It takes at least 2 months to make an investment. An in-house team evaluates the proposal looking at the current and future industry trends and how the company would be able to take best advantage of the same. A detailed due diligence is then conducted for promoters, market, scalability and more importantly, exit to GVFL. You also noted that although you receive 2-3 proposals a week, they don't fit into your criteria. What are the criteria you look for in a proposal? We look at various things such as management, strong ideas that can sell, qualification and a minimum of 10 years experience of an individual and also the background of a person. Besides we look for companies operating in biopharma, industrial biotech, agri-biotech and contract research and manufacturing sectors, which are in a growth stage. Besides Zydus Cadila, who else is the GVFL discussing with to raise the biotech fund? Why will corporate banks invest in biotech fund? And when will GVFL make its first investment? As you are aware, Zydus Cadila has already made commitments to the fund and the size of the investment also may go up in the future. We have approached a few other corporates and banks and the response is positive. We are planning an initial closure of Rs 10 crore by this March end. How do you look at biotech investments in Asia Pacific countries? The governments in Hong Kong, Malaysia, Singapore, and Taiwan are making good investments in biotech. The biotech investments in these countries have increased as compared with investments in India. The government should encourage VCs who are providing seed capital to entrepreneurs by taking initial risks by funding the biotech companies at the grass root level. What are your recommendations to the India Venture Capital Association? The Indian economy is vibrant now. Funds are moving towards private equity. The VCs are looking at biotechnology as an area of investment. The India Venture Capital Association should try to lobby with the government for more seed capital so as to make investments in upcoming biotechnology companies. Narayan Kulkarni ]]> <![CDATA[India to witness more pharma/biotech SEZs]]> https://biospectrumindia.com/news/95/2868/india-to-witness-more-pharma-biotech-sezs.html https://biospectrumindia.com/news/95/2868/india-to-witness-more-pharma-biotech-sezs.html Tue, 11 Apr 2006 16:46:00 +0530 India to witness more pharma India to witness more pharma/biotech SEZs The benefits offered by the government to the developer and the unit-holders through exemptions from all types of taxes and levies have proved to be most conducive and are the force behind private developers to set up and develop SEZs. The Special Economic Zones (SEZs) Act came into force in India on February 10, 2006. Although the Indian government conceptualized SEZs way back in 2000, the absence of a SEZ Act was acting as a deterrent to the flow of private investments into the zones. The philosophy behind SEZs globally is to attract more capital to enhance economic activity in the location and step up exports. Tax sops offered make it a profitable proposition to invest in such ventures. SEZs defined as "specifically delineated duty-free enclave and shall be deemed to be foreign territory for the purposes of trade operations and duties and tariffs," act as engines for export led economic growth in India. The Board of Approval (BoA), Department of Commerce comprising officials from various ministries, cleared 148 of 166 proposals. The proposals cleared contained 75 that had already received approval in principle. The BoA, which met for the first time on March 17, 2006 after the notification of the SEZ rules in February, also set in motion a system of single-window clearance for setting up these SEZs. These SEZs are spread over 15 states and two union territories. The government is expecting that the SEZs would attract Rs 1,000 billion investment and generate 500,000 jobs in the next three years. The investments will convert over 40,000 hectares of the country's land into SEZs. Among major SEZs given final clearance include Biocon's Rs 200-crore biotech project in Bangalore, two proposals by Jubilant Organosys for SEZs in Gujarat and Mysore. Hemant Rajurkar, assistant engineer, Office of the Joint CEO (IT), Maharashtra Industrial Development Corporation, (MIDC), which received approval from BoA to set up Pharma/ biotech SEZs in Jalna, Aurangabad and Nanded said, "MIDC has been working on modalities on setting up the SEZs in pharma/ biotech areas. It is still at the drawing boards. So far the areas for these SEZs have been finalized." Private/sector specific SEZs As on March 31, 2006, there are 811 units in operation in the 8 functional SEZs in India. Investments by the units in these Zones are of the order of Rs 18,309 million. The SEZ units have provided employment to about 1,00,650 people. Internationally, free zones have been "publicly" funded. In India, fiscal constraints are coming in way for the public funding for SEZs. The government has been encouraging participation of private players by offering regulatory and fiscal incentives in setting up SEZs. These SEZs also act as a center for establishing close global contact and thus bringing in fast globalization. The unit holders by remaining in contact with markets globally, add to the globalization growth. "Now that the SEZ rules have been officially notified, it remains to be seen if the FDI trickle turns into a flood. For the same reason the likely perception of some industries is that sector-specific SEZs may in fact facilitate securing a significant increase in FDI. Further, the company involved in the setup of a SEZ may be able to better negotiate incentives from the government and hence enable the units within the SEZ to increase sector-specific trade with a clear focus. Many of the proposals floated for the biopharma industry have been submitted by large biotech and pharmaceutical companies such as Biocon and Ranbaxy. These companies are symbolic of the respective sectors in India and hence enhance credibility of the SEZ as well. The setting up of a sector specific SEZ may turn out to be an important component in the long-term strategy of the parent company," said Utkarsh Palnitkar, director, Health Sciences, Ernst & Young India. He further said, "The existing generic SEZs are required to have a minimum continuous land size. However, such a requirement restricts the establishment of such SEZs to the outskirts of cities. Therefore it makes more sense for companies to create sector-specific SEZs, which are smaller and can be set up in the business districts. This not only optimizes operational costs such as logistics and transportation but also reduces related manpower costs. The sector-specific SEZs may offer infrastructure required by the biotech and pharmaceutical companies such as R&D facilities (wet labs), space for agro-biotech and relevant international linkages with biotech institutions and companies. Further the parent company will have enhanced control on admission of companies into the SEZs." Sharing similar views, Prasant Biswal, CEO, International Biotech Park, Pune said, "The companies will now have a choice to select a location, whereas earlier they were bound to use the shared facilities with other companies. It will be an advantage for the companies to set up SEZ within their existing premises by which they can utilize their R&D and other facilities. By investing in sector specific SEZs, the private players can also reap the benefits of regulatory and fiscal incentives both as developers and as unit holders. It might emerge as a cluster as other companies can also utilize the resources for mutual benefits." Expressing concern over realizing the objective of attracting more capital to enhance economic activity in the location through SEZs, Prasant Biswal said, "The sector-specific SEZs will mushroom in the coming years with more participation from private players so as to reap the benefits of both as developers and unit holders." Echoing a similar opinion, Utkarsh Palnitkar said, "We may witness emergence of more sector-specific SEZs that are mutually beneficial to the state governments and the mentor company." Narayan Kulkarni Australian life science industry shining The market for Australian life science companies has grown significantly over the past five years, according to PricewaterhouseCoopers. At the beginning of CY01, 60 companies were listed on the Australian Sock Exchange (ASX) in the medical device, biotechnology and pharmaceutical development sectors. Now there are 111 companies with diverse technologies, ranging from the developers of antibacterial coatings derived from Australian seaweed to cardiac pump devices for patients with congestive heart failure. The market capitalization of these companies at the end of CY05 was more than $20 billion compared with about $11 billion five years ago. Over the past five years life science companies (excluding the majors Cochlear, CSL and ResMed) have performed well, though their share prices have been volatile. During the five years from 2001 to 2005, the sector's value (excluding majors) increased by 58 per cent. The All Ordinaries performed strongly over the same period, gaining 49 percent. The sector rallied strongly in early CY03 and there were 15 initial public offerings in the second half, but at year's end only nine companies were valued at more than $100 million. The out performance of a small number of stocks in CY03 contributed to the sector's subsequent volatility. In CY05 there was an increase in the number of listed companies and the capitalization of individual companies became more dispersed, according to PricewaterhouseCoopers. In the first half there were more negative than positive performers, which pulled the sector down, while in the second half new companies emerged as strong performers. Pharmaxis, Mesoblast, Peplin and Biota made strong contributions in the second half. At the year's end, 15 companies were valued at more than $100 million. PricewaterhouseCoopers views the change in the market over CY05 as a positive for investors, with more companies being rewarded for pushing towards the realization of their technology's potential. Medical device companies Vs biotechnology and pharmaceutical developers The number of listed medical device companies tripled over the period 2001 to 2005, from 10 to 30, while the number of pharmaceutical and biotechnology developers doubled to 79 during the same period. Although both markets have increased considerably, the average capitalization for companies in the medical device sector (ex majors) has declined by 47 per cent while the average value of biotechnology and pharmaceutical developers has increased marginally, by7 percent. Many medical device companies have come to market reliant on the commercialization of a single product. Typically medical devices require a shorter time to develop and commercialize than biotechnology and pharmaceutical research. Keeping legal work local Adelaide patent attorney firm Madderns has set up a life sciences team to attract work from South Australian biotechnology firms and laboratories. After poaching biotech specialist Mark O'Donnell from Melbourne, the firm also hired doctors of science and legal experts for its seven-member team to compete with interstate and other Adelaide patent offices such as Phillips Ormonde Fitzpatrick. About five patent attornies are based in Adelaide. O'Donnell is an honours graduate in biochemistry from the University of Adelaide and has worked in the patent industry for almost 20 years. Madderns senior partner Richard Catt said the aim was to work for clients who previously had looked interstate. "A lot of the work's been going across the border," he said. O'Donnell said some publicly listed companies and research centres were unaware of those elements of their work that could be legally protected, particularly with the different laws that apply in the US and in Europe. Those markets were important for patent approval because they were home to the world's largest pharmaceutical companies. "It's not uncommon for good intellectual property not to be fully appreciated by the innovator, or they might come to the conclusion that it's not protectable," O'Donnell said. Areas such as stem-cell biology immunology, bioinformatics or databases of biological information such as genome sequencing, and nanotechnology were all important areas needing patent expertise, he said. Patents have become the lifeblood of listed companies such as Adelaide's Bionomics which has patents and patent applications relating to more than 600 genes in the diagnosis and treatment of central nervous system disorders such as epilepsy and anxiety. Sydney company Biota is suing its marketing partner, GlaxoSmithKline, over intellectual property of its flu drug, Relenza, which Biota developed and is entitled to royalties on sales. The company is claiming damages of up to $430 million. Source: www.theadvertiser.news.com.au ]]> <![CDATA[Nanotechnology is the buzzword]]> https://biospectrumindia.com/news/95/5265/nanotechnology-is-the-buzzword.html https://biospectrumindia.com/news/95/5265/nanotechnology-is-the-buzzword.html Tue, 11 Apr 2006 16:44:00 +0530 Nanotechnology is the buzzword Nanotechnology is the buzzword India has a huge potential to market nanotech products. Careful and select investments in nanotechnology can catalyze the country's economic development and stability and pave way for its transformation into a developed nation by 2020. The convergence of nanotechnology and biotechnology has created an opportunity for the innovative development of medical advances spanning the continuum of drug discovery and development. Nanotechnology offers cheaper and faster medical diagnosis, new therapeutics and novel methods of drug delivery with many of these technologies currently in preclinical or clinical development. Because of the creation of nanotechnology tools, we are finally on the verge of taking biotech to the nanoscale-and the view is breathtaking. Convergence of nanotechnology, a functional engineering on an extremely small scale with biotechnology will not only produce high tech products at low cost but will also prolong life via preventing illness and improved health. India cannot afford to miss the revolution in nanotechnology and must make investments in the area carefully. "We cannot do that again in the area of nanotechnology which may become big in the next five-six years," noted eminent nano scientist CNR Rao. It was important to select areas to make investments in nanotechnology. Only in the next 10-15 years, the effects of nanotechnology would start becoming visible. Research in nanotechnology is being carried out in about 20 academic and scientific institutions like University of Delhi, IIT (Mumbai, Kharagpur, Delhi), DRDE (Gwalior), IISc (Bangalore), NCL (Pune), NIPER (Chandigarh) and CCMB (Hyderabad). The Department of Science and Technology has allocated Rs 100 crore for R&D under scheme 'Nano sciences and Nanotechnology Initiative'. This is very small in comparison to the investments made in other countries like the US, the UK, Germany, and Japan. There is a need to increase funding in nanotechnology. Prof Jayesh Bellare, head, projects Nano biosciences, IIT Bombay said, "The industry is also exploring the opportunities in nanotechnology. There are about 100 odd pharmaceutical/ biotechnology and biomedical companies in India are working on nano-based technologies. As of now the major funding for nanotech R&D is happening from government agencies. The private sector too is spending on nanotech but it is very small in size." Organizations Considering the huge market potential for nanoparticles in India, companies from China, Japan and Iran are entering the domestic market through tie-ups. An Iranian company called Tide Waters has entered into a tie-up with Mumbai-based SSB Technology to market its range of products under the brand Nanocid in India. Sharing his views about the Indian market potential for nano materials/particles, M Karagarfard, a nano biotechnology expert and engineer in chief at Tide Waters said, "We know that our Indian friends know their responsibility towards the society much better. The more the population the more the problems. We would like to solve the problems though our range of products. We are also planning to set up a manufacturing plant in India so as to export to other neighboring countries like Bangladesh, Pakistan from India. At present we are producing 50 metric tons of nanoparticles at Iran to meet the demand from customers based in Canada, Turkey, Ankar and Italy." Besides public sector R&D institutions, there are companies in India that are working/doing research on nanotechnology. They are Cranes Software International Limited, Monad Nanotech, Velbionanotech, Innovations Unified Technologies, Qtech Nanosystems and Naga Nanotech India. According to Anurag Gupta, CEO, Yash Nanotech, business information and consulting arm of Yash Management & Satellite Ltd, specialized in nanotechnology, "There are a handful of companies involved in the business of nanotechnology in the country. The government funding in nanotechnology R&D will be about Rs 100 crore in the next five years. Leading companies like Reliance, Tata Group and Mahindra and Mahindra are also making investments in this upcoming space. There is very good scope of growth in biomedical and diagnosis space." Cranes Software International Limited has research set up for MEMS and Nanotechnology at India's leading institutions like the IISc, Bangalore. Velbionanotech, ranked ASIA's Top 100 Bio Nanotechnology companies by Red Herring in 2005, is designing drugs for various diseases such as heart disease, kidney stones, AIDS, cancer, cosmetic generic products using a short fragment of DNA as a new type of drugs. These drugs are assembled in nanochips and as nano particles for delivering in human body, which are affective in curing the sick/diseased and healing the injured. Velbionanotech product and technology are focused for molecular level. BioNano products are diverged as Biochip and Nanomedicine. VBN's bionanotechnology products are categorized as bionanochip, nano medicine, nano material, Microdoctor, nano sensors and herbal medicine. Monad Nanotech is another company producing carbon nano materials (CNM) commercially using low cost production technology developed by Prof Maheswar Sharon's group at IIT Mumbai, who has two patents and 38 research publications to his credit on carbon nano materials. The team has been working on not only synthesis of carbon nano material; but also on their futuristic applications. Monad Nanotech has been supplying many nano materials - MWCNT1-3 Nano beads 1-2, nano fibers 1-4, fibrous carbon nano size metals and porous carbon gas diffusion fuel cell electrodes- to the research organizations in India. Dr Madhuri Sharon, managing director, Monad Nanotech, feels the market for nanotech particle is very huge and growing very fast. Besides doing research and development and producing nano materials, Monad Nanotech has taken up the agency of Shenzhen Nanotech Port Co. Ltd., (NTP) China for sales rights in India and Canada. Similarly Monad has taken the agency of Meijo Nano Carbon, Nagoya, Japan for world marketing rights for its products excluding Japan. Innovations Unified Technologies conceptualized by a group of IIT Bombay alumnus, having specialization in nanotechnology, working on to supply small and bulk quantities of MWNT/SWNT produced by its pilot plant in three different grades. Qtech Nanosystems is a "technology incubation enterprise" focused on making products based on nanotechnology. It is currently engaged in product development and commercialization for Nanopositioning stages for nanotechnology and other varied precision applications. In addition to these we find companies that are supporting these companies with tools and analytical equipment. According to NanoIndian.com, FEI Company, Veeco Asia, Nanosolar, Sigma Aldrich, Nanoprobes, Quantum Sphere, Nanonics Immaging, an Israeli company represented by Labindia Instruments, VWR, Icon Analytical Equipment and Forevision Instruments are active in selling nanotechnology tools to the Indian companies. There are non-government organizations working to act as bridge between academy and industry in nanotechnology. The Nanotechnology Research and Innovation Foundation (IndiaNano) is one such non-profit organization supported by academic and industry experts aimed at developing a platform for real-time strategic collaboration between diverse groups in order to harness the benefits of progress in advanced technologies, including nanotechnology. This initiative is seed funded by IndiaCo, a private equity investment holding company that invests in hi-tech companies that can access global markets and supported by National Chemical Laboratory, Girvan Institute of Technology and The Centre for Materials for Electronics Technology. The IndiaNano has "Innovation Acceleration Network (IAN) designed to bridge the gap between invention and commercial reality, by providing pragmatic support for technology entrepreneurs in the areas of Operations, Intellectual Property Management, Business development and Technology Transfer so as to create ventures that could compete in global markets. In January 2006 the Nanotechnology Research and Innovation Foundation and the Regional Research Laboratory, Trivandrum (RRL-T) have forged a strategic partnership that will allow the pooling of their respective expertise and thereby facilitate the commercialization of technologies within RRL to the industries in India and across the globe. The Nano Science and Technology Consortium is another organization that works to create a platform conducive for the growth, promotion and partnering in the field of Nano Science and Technology taking together industries, academics and government through consultative, advisory and educative processes which will provide growth platform for organizations, academics and governments for harnessing the nano potential at global level. It is a non-governmental, industry-managed and promoted organization with a role of facilitator for nano developmental processes. Opportunities The world for nanomaterials in electronic, magnetic and opto-electronic applications is supposed to increase from $333 million in 2000 to $667 million in 2005 at the world level. This shows that there is a strong economic incentive to develop this new specialty area. This is also reflected in the launching of National Nanotechnology Initiative (NNI) in July 2000 in the US and Nanomaterials Science and Technology Initiative (NSTI) in 2003 in India. Considering the potential, in 2005 Cientifica announced the launch of a joint venture with India's YashNanotech to outsource nanotechnology R&D. Cientifica will serve as the public international face of the venture, while Yash will manage the Indian operation. Anurag Gupta of YashNanotech said, "The company is already in advanced talks with a number of world-class Indian research institutes, and is planning to set up a number of manufacturing units and facilities designed to take advantage of the new materials and markets enabled by nanotechnologies. "Veeco Instruments opened a nanoscience center in Bangalore in partnership with the Jawaharlal Nehru Center for Advanced Scientific Research. Veeco, which makes atomic force microscopes and other nanotechnology research equipment. The company sees not just a new R&D outsource location but also a burgeoning market for its products. Dr Murali Sastry, chief scientist, Tata Chemicals, said "India has huge potential in nanotechnology. Unlike services, it is knowledge-based industry with long gestation period just like biotechnology. Hence India needs a paradigm shift. With strong public private partnership and no government interference, the nanotechnology industry will reach new heights in the coming years." Dr Ramgopal Rao, head, center for research in nanotechnology and science, Indian Institute of Technology, Mumbai said, "The WHO has predicted exponential rise in cardiac problems among Indians by 2020. This is mainly because of changing in eating habits and other health related issues. Even there is demand from the medical fraternity for biochips, markers, and sensors so that they can identify and diagnose the disease at early stage. So diagnosis has emerged as a key area of research for Indian scientists to work using nanotechnology." Sharing his thoughts, Prof Jayesh Bellare, head, project Nano biosciences, IIT Bombay said, "There are vast opportunities for nanotechnology in biotechnology in the field of biomedical, pharmaceutical and diagnosis space. Although the market is not so big but it has good potential to grow big." He also stressed on the need for strong relation between industry academia in nanotechnology. Dr Rajah Kumar, CEO, Center for Advance Research & Development said, "Early diagnosis, drug delivery system, biomarkers are areas where nanotechnology has applications that will have a big impact on the quality of human life in India and have greater impact on Indian healthcare economy." Commenting on the opportunities for India, Tim Harper, CEO, Cientifica Ltd said, " In three key areas - primary industries, local solutions, world class niches-India has a lot of potential which includes medical and pharmaceutical industry. Increase in better life style and early diagnosis, prevention of many diseases, reduce cost on healthcare would drive the growth of nanotechnology in India. Large companies like Reliance, Tatas are looking at nanotechnology to produce home grown technologies to meet the local demands/ requirements. Although China has about 1000 start-ups in nanotechnology, India has an edge over China because of its skilled and talented human resources." Dr GU Kulkarni, nanomaterial group member at Jawaharlal Nehru Center for Advanced Scientific Research, said, "There is enthusiasm among the people about nanotechnology and they want to participate in this sector. But there are issues like policy, monitoring, implantation, which need immediate attention." Besides, the other key bottleneck facing the development of nanotechnology in India is the venture capital funds necessary for further growth of the companies. Hence KL Chugh, chairman, ASSOCHAM Knowledge Millennium Council sought creation of mega fund which should run in crores of rupees and encourage research and detailed knowledge in nano and bio technologies and also create a climate so that youngsters are motivated to study physics, chemistry and biology as these sciences would always have a potential to generate research that will create abundance in wealth. Government initiatives Realizing the huge potential of this technology, the Government of India has started supporting various research and commercialization activities related to nanotechnology. The Department of Science and Technology through its Nano Science and Technology Initiative (NSTI) supports R&D by individual scientists. It has been instrumental in the establishment of research facilities and setting up core groups and awareness programs through seminars and conferences. Even the Department of Biotechnology has been funding many projects on nano biotechnology. The Department of Industrial Policy and Promotion under the Ministry of Commerce and Industry has also prepared a program on applications of nanotechnology in the manufacturing sector to be submitted to the Planning Commission for the 10th Plan. The President of India, Dr APJ Abdul Kalam has also been promoting nanotechnology as the vehicle for increasing wealth and improving the quality of life in the impoverished nation of more than a billion people. He emphasis is on the technology's role as a catalyst for economic development and stability. His goal is to 'transform India into a developed nation by 2020'. Dr Kalam said, "Nanotechnology is knocking at our doors". It is the field of the future. India has to utilize this opportunity as it has tremendous application potential in the areas of medicine, electronics and material science. This technology is still in its infancy in the country. Scientists are trying to establish interdisciplinary centers for nanotechnology research. There is lack of understanding about nanotechnology between bureaucracy and polity and other wings of policy making in India. They are yet to understand the significance of convergence between nano and biotechnologies and other fundamental sciences as a result of which India is far behind in their integration from economies of scale. Admitting this, Kapil Sibal, Cabinet minister for science and technology said, "Until a coordinated and pro-active approach was adopted towards integration of advance sciences, the best of inventions undertaken by our scientists will fail to get project coordination work that will evade us investments and higher yield in areas of agriculture, horticulture, food products and even in manufacturing." He therefore sought a paradigm shift in the current behaviour and thinking pattern of Indian polity, its bureaucracy towards generating alliance and integration of advance sciences like nano and bio technologies to keep India ahead of all developing economies that are either its neighbor or in the far east region. The current prototype approach of policy makers towards scientific developments needed to be reversed to move India forward so that it can rise and increase its outputs through adoption of integration of nano and bio technologies that will bring about revolution in the field of Indian agriculture and even manufacturing. The minister also felt that India needs to launch an intensive and aggressive political movement that can bring about the required alliance and convergence between bio and nano technologies to make it a leader in harnessing its natural wealth in sectors like agriculture, horticulture and manufacturing. Dr Kalam has proposed the establishment of "World Knowledge Platform" which will combine the core competence of the partners in the area of convergence of technologies in bio-info-nano technologies for the design, development and product realization. "I am confident that the Indian nano technology initiatives are maturing into marketable products for worldwide applications. Industries from abroad and India are keen to take our technologies and to commercialize. Indian industries should now take the lead and become a partner in the nano science and technology ventures to capture the international market," Kalam added. Global scenario According to researchers at the University of North Carolina, nanoparticles might enable a more targeted and effective delivery of anti-cancer drugs than current treatments and have the potential to reduce side effects associated with chemotherapy. The nanoparticles are designed at the molecular level to attack specific kinds of cancer without harming healthy cells, This is one example for the application of nanotechnology. They are many more that can change the life of human beings. As per reports, approximately $65 billion in drug revenues every year are accounted for by pharmaceuticals with poor bio-availability which far too often results in higher patient costs and inefficient treatment and more importantly, increased risks of toxicity or even death. Because nanotechnology focuses on the very small, it is uniquely suited to creating systems that can better deliver drugs to tiny areas within the body. Nano-enabled drug delivery also makes it possible for drugs to permeate through cell walls, which is of critical importance to the expected growth of genetic medicine over the next few years. Considering the applications of nanotechnology in the various fields, the next ten years will see nanotechnology playing the most dominant role in the global business environment and is expected to go beyond the billion dollar estimates and cross the figure of $1 trillion. The market share for nanotechnology products such as nanomaterials will be about $340 billion, electronics and semi conductors will be $300 billion, pharmaceutical will be around $ 180 billion and aerospace and chemical plants and tools will be around $ 200 billion. In BRICS countries, the market for nanotechnology is expected to be about $1 billion. The governments and corporates the world over are investing a lot on nanotech R&D activities. The worldwide nanotechnology R&D investment reported by government organizations has increased approximately five times in the last five years between 1997 and 2002. At least 30 countries have initiated national activities in this field. Scientists have opened a broad net of discoveries that does not leave any major research area untouched in physical, biological, and engineering sciences. The industry has gained confidence that nanotechnology will bring competitive advantages. The worldwide annual industrial production in the nanotech sectors is estimated to exceed $1 trillion in 10-15 years from now, which would require about two million nanotechnology workers, according to MC Roco, senior advisor for nanotechnology, National Science Foundation. The US has lead the way by allocating $800million in funds to the 2004 National Nanotechnology Initiative (NNI). The House of Representatives has also approved a Bill that plans to allocate $2.36 billion to nanotechnology programs over the next three years, not to mention the substantial state funding programs. Japan is next up, with almost $750millon in funding in 2002 and the European Union is assigning nanotechnology special status in the new Sixth Framework Programme. Tim Harper, CEO, Cientifica Ltd, a London-based global nanotechnology business intelligence and strategic consulting services company, said, "About $12 billion is being pumped into R&D activities across the world on nanotechnology R&D. It includes both private and public funding." Narayan Kulkarni ]]> <![CDATA[Creating awareness to curb sale of fake Bt seeds]]> https://biospectrumindia.com/news/95/2779/creating-awareness-to-curb-sale-of-fake-bt-seeds.html https://biospectrumindia.com/news/95/2779/creating-awareness-to-curb-sale-of-fake-bt-seeds.html Tue, 11 Apr 2006 16:39:00 +0530 Creating awareness to curb sale of fake Bt seeds Creating awareness to curb sale of fake Bt seeds Year after year there has been an increase in the sale of Bt cotton seeds but at the same time one can also see proliferation of spurious Bt seeds in the country. This is mainly due to lack of awareness on the advantages of legal Bt cottonseeds and strict monitoring by the implementing agencies. Since the commercialization of the first GM crop i.e. Bt cotton in April 2002, several efforts have been made by various government agencies as well as industry bodies to spread education and awareness among the stakeholders associated with genetically modified (GM) crops. In February 2006, the All India Crop Biotechnology Association (AICBA) organized a workshop in Ahmedabad on technical and legal issues related to transgenic/GM crops in India for the district agriculture officials from Gujarat. The workshop assumes significance in view of the large-scale spread of unapproved Bt cotton cultivation across cotton-growing states. AICBA believes that education and awareness amongst agricultural officials, traders, dealers, industry associations and growers is the need of the hour and plans to hold similar programs in other cotton growing states. Increase in sale of Bt cotton In the last four years, the number of Bt cotton hybrids has increased from three (with only one company â€“ Mahyco Monsanto Biotech India in 2002) to 20 hybrids in 2005 with four companies selling Bt cotton seeds in nine states except the eastern zone of the country. In 2005, India had by far the largest year-on-year proportional increase, with an almost three-fold increase, from five lakh hectares in 2004 to 13 lakh hectares, exclusively in just one GM crop-cotton. Bt cotton. This has brought down the sale of non-Bt cotton seeds from 15 lakh packets last year to five lakh. In the last cropping season, Bt cottonseeds were sold to the farmers at Rs 1,850 for a 450-gm pack, of which a major share of Rs 1,250 was paid as royalty to Mahyco Monsanto Biotech (India) Ltd (MMB), a 50:50 marketing joint venture between Mahyco and Monsanto Holdings Private Limited for transfer of the 'trait value' into the seed. The NGOs representing the farmers group alleged that the technology developer, Monsanto was collecting higher royalty from Indian farmers by collecting Rs 1,200 as against Rs 34 in China and Rs 108 in America as royalties for its patent rights. The high cost of Bt-cotton seeds, which promises protection from the bollworm menace, has led to proliferation of spurious seeds resulting in crop failures and distress to some farmers leading to even suicide. Sale of illegal Bt cottonseeds According to Afsar H Jafri of Research Foundation for Science, Technology and Ecology (RFSTE), the sale of illegal Bt cottonseeds is a matter of grave concern. Proliferation of these illegal varieties include Azadi, Anmol, Best, Maha Anmol, Sudarshan, Aiklav, Bahadur, Gold, Maha Gujarat, Sema, Sartaj, Kamander, Balwan, Mold, Om-1, 2 & 3, Rakshak, Patidar-8, Navbharat 55, 151, & 11, Parth, Sarthi, Paramarsh 10, Surakksha, Anand-41, Jai Ratan, Navratan, Varsha, A1- Homeguard, Bullet-707, Manmold and Sona. A study conducted by another NGO, Gene Campaign has showed that illegal Bt cotton varieties like Bunny Bt, Super Bunny, H-8 and Om-3 were sown in 2004 season. The illegal sale of unapproved Bt cotton has spread to Punjab, Haryana and Rajasthan. There is a big market of spurious and illegal Bt cotton seeds in these states as it is made available at a relatively low price to farmers by those engaged in this business. According to reports, agents in Punjab and Haryana procure the illegal and spurious seed at a rate varying between Rs 250 and Rs 500 per packet weighing 450 gram and they further sell it for Rs 900 per packet, which is much lower than the market price of the legal Bt cotton seeds. Coming under heavy pressure from the governments, MMB has finally reduced the technology fee charged to seed companies for use of its insect-protected cotton technology in order to best meet current market conditions. ?In the coming season, the technology fee would be Rs 900 per 450 gm packet of Bollgard cotton seed, approximately 30 percent less than last year's technology fee of Rs 1,250 per packet. "This change in the technology fee will give MMB's seed company licensees an opportunity to pass along new savings to farmers if they choose. ? If seed companies do choose to lower their final seed prices, we believe that this will encourage more farmers to choose genuine Bollgard technology, because of its clear benefits," said Sarita Bahl, senior manager â€“ public affairs, Monsanto Holdings Private Limited. This will support the seed companies to offer the legal Bt cottonseeds to the farmers at an affordable price. Government initiatives In addition to the industry's intiatives the state governments have been advised to constitute special flying squads to check the sale of illegal Bt cotton seeds and undertake massive campaigns to educate farmers on the subject. The Union Ministry of Agriculture ministry, on being aware of the illegal sale of unapproved Bt cotton seeds, has directed the state governments concerned to strictly enforce the provisions of Seeds Control Order 1983, to deal with the situation. The environment ministry has constituted a committee to institute a monitoring verification mechanism to assess the performance of approved Bt cotton seeds. The Union Ministry of Agriculture recently convened a meeting to discuss various issues related to Bt cotton. It has requested the state governments to deal strictly with elements engaged in the sale of spurious and illegal Bt cotton seeds. Even states like Punjab, Haryana and Maharashtra have joined hands to stop the sale of illegal Bt cotton seeds as also the sale of spurious Bt cotton seeds from Gujarat. But the agriculture officials are caught up because of lack of a forceful legislation. According to the provisions of the Seeds Act, no action can be taken if the seeds are sold loose (without being packed and sealed). The sale of unpacked seeds does not attract penal action, thus paving the way for irregularities. Though the state governments have been taking several measures to check illegal sale of Bt cotton seeds, the seeds have been reaching farmers either through traders or farmers retaining the seeds of the previous year. Dr RA Sherasia, director of Agriculture Department, Government of Gujarat, said, "Our department is committed to educating the farmers to ensure that the farmers purchase Bt cotton seeds from recognized sources only. We also aim to provide the agronomical know-how regarding cultivation of Bt cotton and critical points to look after it through mass media and preventing sale of F2, unauthorized and other spurious seeds that are currently being sold under the guise of genuine Bt seeds." Along with strict monitoring and implementation of the laws of the land, the government should also look into the other issues like giving approvals to newer varieties so that the farmers sow only the approved varieties. Throwing light on the legal framework applicable to transgenic crops in India, Kirit Javali of Jafa & Javali Advocates said, "There is a misconception and confusion prevailing that action can be brought only under the Seeds Act, 1966. However, the 1989 Rules under the Environment (Protection) Act (EPA), 1986, it is specifically provided that no products containing genetically modified micro-organisms in relation to Bt cotton can be sold without the mandatory approval of GEAC and further that penalty provisions are stipulated under Section 15 of the EPA where action can be initiated." He further said, "The Government of India has brought out the new Seeds Bill, 2004 through the Agricultural Ministry and is trying to remove the distinction between notified and other varieties. All types of seeds must now be registered under the proposed Seeds Bill, 2004. The Bill is presently before the Standing Committee of Parliament on Agriculture for consideration." Keeping in mind the significance in view of the large scale spread of unapproved Bt cotton cultivation across cotton growing states, AICBA felt it became necessary to educate and create awareness amongst the agricultural inspectors, traders, dealers, and industry on the prevailing laws. AICBA plans to hold similar programs in other cotton growing states to curb the menace of illegal Bt cotton. This will go along way is helping the industry to grow by offering quality seeds to the farming community at an affordable price. Narayan Kulkarni   ]]> <![CDATA[Biotech crops reduce pesticide use, green house emissions: Global study]]> https://biospectrumindia.com/news/95/2800/biotech-crops-reduce-pesticide-use-green-house-emissions-global-study.html https://biospectrumindia.com/news/95/2800/biotech-crops-reduce-pesticide-use-green-house-emissions-global-study.html Tue, 11 Apr 2006 16:38:00 +0530 Biotech crops reduce pesticide use Biotech crops reduce pesticide use, green house emissions: Global study An eminent agricultural economist, Graham Brookes, specializes in examining the impact of policy, trade agreements and technology change or agricultural and related sectors. He also has been providing research and consultancy in the farm sector for a wide range of clients in both public and private sectors. During his recent visit to India, he shared the findings of his study "GM Crops: The global socio-economic and environmental impact-the first nine years 1996-2004". Excerpts from the report in the Indian context: After almost a decade of commercialization, biotech crops have made a significant impact on the global economy and environment, decreasing the reliance on pesticides and reducing the environmental footprint associated with pesticide use by 14 percent, according to a global study on the socio-economic and environmental impact of biotech crops. "Since 1996, adoption of biotech crops has contributed to reducing greenhouse gas emissions from agriculture and decreased pesticide spraying," said Graham Brookes, director of UK-based consulting firm PG Economics and one of the authors who conducted the study. Sharing the findings of his study, he said, "While greatly enhancing, the way farmers in 18 countries produce food, feed and fiber, biotech crops have reduced the environmental footprint associated with agricultural practices. This study offers the first quantifiable global look at the impact of biotech crop production." The study, "GM Crops: the global socio-economic and environmental impact-the first nine years 1996-2004," reported that biotech crops contributed to significantly reduced greenhouse gas emissions from agricultural practices. This reduction results from decreased fuel use, about 475 million gallons in the past nine years and additional soil carbon sequestration because of reduced ploughing or improved conservation tillage associated with biotech crops. In 2004, this reduction was equivalent to eliminating more than 22 billion pounds of carbon dioxide from the atmosphere or removing 5 million cars-10 percent of cars registered in India-from road for one year. Globally insect resistant cotton has increased farm income by $ 5.7 billion since commercialization. GM insect resistant Bt cotton has been planted commercially in India since 2002. According to the study, in India the adoption of insect-resistant cotton has increased its farm income by Rs 558 crore. Since the authors of the study were not able to identify relevant insecticide usage data by active ingredient for conventional and GM insect resistant cotton in India, the insecticide usage data from Australia and China was used as they are the nearest countries using the technology in terms of the climate. The respective differences for pesticide active ingredient use and field Environmental Impact Quotient (EIQ) values for GM and conventional cotton used as the basis for the analysis in India were: Conventional cotton-average volume of insecticide used was 8.5 kg/ha and a field EIQ/ha value of 256/ha; GM Cotton-average volume of insecticide used was 2.82 kg/ha and a field EIQ/ha value of 60/ha. Based on these values the level of insecticide active ingredient use and the total EIQ load, in India in 2004 was respectively 4.2 percent (2.84 million kg) and 4.3 percent (98 million EIQ/ha units) lower than would have been expected if the total crop had been conventional non-GM cotton. Cumulatively, since 2002, the insecticide active ingredient use was 1.8 percent lower (3.66 million kg) and the total EIQ load 2 percent lower. The study found that globally biotech crops have reduced the volume of pesticide spraying by 6 percent since 1996, a decrease of 380 million pounds according to the study. That is equivalent to eliminating 1,514 rail cars of pesticides' active ingredient. The largest environmental gains from changes in pesticide spraying have been from biotech soybeans and cotton, which have reduced the associated environmental footprint by 19 and 17 percent, respectively. According to the report, the industrialized nations of the United States and Canada, as well as the developing nations of China, South Africa and Argentina, experienced the greatest reductions in the environmental impact of crop production. "As the world is increasingly focused on the need to reduce greenhouse gas emissions, it is clear biotech crops are already making an important positive contribution to achieving this goal," Brookes added. In addition to environmental gains from the biotech crops, substantial net economic benefits at the farm level have been realized. Since 1996, global farm income has increased by a cumulative total of $27 billion derived from a combination of enhanced productivity and efficiency gains. This increase in farm income is equivalent to adding 3-4 percent to the value of global production of the four main biotech crops. Herbicide-tolerant soybeans have generated the greatest gains at more than $17 billion in increased income, while biotech cotton farmers improved their income by $6.5 billion in the past nine years. In addition to the significant measurable benefits, valuable indirect benefits that are more difficult to quantify can be credited to biotech crop adoption. These include increased management flexibility, facilitating reduced tillage practices, reduced production risk and improved crop quality. The report stated that more than 8.25 million farmers in 18 countries around the world have adopted biotech crops, and 90 percent of those are resource-poor producers located in developing countries. ]]> <![CDATA[Reviving the virus of 1918 flu]]> https://biospectrumindia.com/news/95/1505/reviving-the-virus-of-1918-flu.html https://biospectrumindia.com/news/95/1505/reviving-the-virus-of-1918-flu.html Tue, 11 Apr 2006 16:35:00 +0530 Reviving the virus of 1918 flu Reviving the virus of 1918 flu In an attempt to understand the nature of influenza pandemics, scientists have revived the virus that caused the flu of 1918, raising many questions. "It is simply a struggle for air until they suffocate" (Grist, 1979) - a physician who treated influenza patients during the 1918 flu pandemic. The 1918 flu was the worst pandemic to hit mankind in recorded history, a scourge that killed more than 20 million (some reports put the number at 50 million) people worldwide. More people died of influenza in a single year than the four years of Black Death Bubonic Plague from 1347 to 1351. Yet has a disease of such mammoth proportions that occurred in recent history been largely forgotten? Not really, if recent reports are any indication, especially since experts have warned the possibility of another devastating pandemic and the need to be prepared for it. And in the quest for that preparedness, scientists have brought back the 1918 influenza virus to life! A team of scientists headed by Terrence Tumpey, a research scientist at Centers for Disease Control and Prevention (CDC) in Atlanta, USA announced the reconstruction of the virus that caused the deadly 1918-19 pandemic. The work was done in collaboration with Mount Sinai School of Medicine, Armed Forces Institute of Pathology and Southeast Poultry Research. The findings were published in the October 7 issue of Science. The landmark research has identified genes and characteristics, which were responsible for making the 1918 virus so virulent. It is expected to help in understanding the mechanism for generation of pandemic strains. It will help in the development of new therapies and vaccines to protect against another such pandemic. Says Professor Garcia-Sastre chief investigator of the project at Mount Sinai Hospital, "The significance of the reconstruction of the 1918 flu virus is to understand the genesis of a pandemic. Now will the H5N1 become pandemic? Nobody knows. People say that mutation from avian to human is inevitable, I don't know where people get that information. But if we know what makes a virus pandemic we can optimize surveillance for emerging strains and be on the alert when we see pandemic-like quality appear in the virus." Scientists are hopeful that the study will throw light on how a virus, which normally remains stable in birds, develops into such a deadly strain in humans. Influenza pandemics occur when a new strain emerges to which people have little or no immunity. There have been four influenza pandemics in the recorded history: 1890, 1918,1957 and 1968. Most experts fear the outbreak of another pandemic but nobody is sure about the timing, type of strain or the severity of such a calamity. Mapping the reconstruction efforts This real possibility of a pandemic spurred the scientific community to launch the drive for preparedness. For this, scientisists had to find out the mechanisms by which the virus becomes deadly and spreads from human to human. The eight genes which made up the interior of the 1918 influenza viral particle or its genetic sequence had to be deciphered. Initially scientist thought that the virus could be recovered from the frozen lungs of dead victims of 1918 pandemic buried in Alaska. However, they found that the virus was too fragile to remain intact and hence that attempt failed. A more prudent approach was to find the genetic code which will reveal the secret of its virulence. This time the source was the frozen lung specimen of a soldier who died in September 16, 1918, that was stored in the tissue repository of the Armed Forces Institute of Pathology (AFIP). Using a technique called Polymerase Chain reaction (PCR), scientists at AFIP were able to extract influenza RNA fragments from the lung tissue. They reported the initial results of genetic characterization of the 1918 Spanish influenza virus in the March 1997 issue of Science. The group from AFIP reported on the details of the final three genes in 2005, October issue of Nature, thus characterizing the complete genetic sequence (Genome) of the 1918 virus. Jeffery Taubenberger was the lead author of the sequencing study. According to their analysis, the 1918 virus was derived from the avian influenza virus. The virus causing the 1957 and the 1968 epidemics acquired their pathogenecity by reassortment of the genes between an avian influenza strain and the then circulating human strain. Reassortment occurs when two different influenza strains infect a cell and a hybrid virus gets generated that contains genetic materials from both viruses. The 1918 virus, however, was not generated by reassortment but was wholly derived from virus that originally infected birds. Simply stated it was a bird virus, which acquired the capability of infecting humans and spreading from one person to another. The current avian flu viruses have also infected humans but the potential to spread among humans is low. Scientists fear that in due course the virus may adapt and acquire such an ability leading to another 1918 like pandemic. Scientists at Mount Sinai hospital in New York worked to transform the code into genes by using Taubenberger's blueprint. The reconstruction of the virus was done using a molecular technique called "reverse genetics". This technique was developed and patented by Drs Adolfo Garcia- Sastre and Peter Palese that creates viruses from DNA and is widely used in laboratories that work on influenza. Reverse genetic enable researchers to quickly build custom viruses. The final reconstruction of the viable virus and tests on the mice for its pathogenecity were done at the laboratory in Centers for Disease Control and Prevention (CDC). In reconstructing the virus, the team of researchers headed by Dr Terrence M Tumpey, a senior microbiologist at CDC, experimented on various combinations of genes. In this process they found out the genes which made the virus so deadly. The reconstructed virus was used to infect the mice and after just 4 days it replicated to produce thousands of virus particles. The mice lungs were flooded by the virus particles and all the mice died within 6 days of infection with the reconstructed 1918 virus. To do or not to do: the ethical question The paper raised a lot of debate in media. The need to resurrect a lethal virus, which could potentially escape and play havoc, was questioned by media and experts alike. Whether the benefits outweighed the risks of this recreation was hotly debated. So what are the risks? The 1918 flu virus was extremely virulent, perversely affecting the young and healthy population between the ages of 15-34. Flu is a seasonal disease and during such seasonal outbreaks, complications and death occur in the very young and the very old. Skeptics fear two issues: what if the virus escapes from the laboratory? Firstly the chance of virus escaping is very low. The work has been done in laboratories with Animal Biosafety Level 3 practices with special enhancements. Biosafety level 3 practices include a combination of stringent containment measures and procedures for protection of personnel, environment and the community. Well, theoretically, the virus, if it escapes, can lead to a disaster. "But in reality it wouldn't have the same consequences as the 1918 pandemic. There is some residual immunity to the 1918 virus present in a portion of human population. Moreover current anti-virals and vaccines are effective against the 1918 virus," says Garcia-Sastre. In fact the research staff at the CDC took prophylactic antiviral medications to protect them. The second concern relates to the issue of bioterrorism. What if terrorists use is as a tool with the availability of the blueprint for this virus. This concern is also widely ruled out as a pandemic will strike indiscriminately affecting all nationalities as it spreads across the globe. Some experts are skeptical about the utility of such an exercise. They say that a systematic risk-benefit analysis has not been done. According to them the statements about the benefits are too general and do not provide a concrete evidence of the benefits. The research is more about basic understanding of the virus than any direct health benefits. According to them, the added value of one additional strain of influenza virus is very limited. Most experts feel that the next pandemic strain will emerge from an avian influenza strain. The article in Science also validates this theory. The results of this research, skeptics not withstanding, will immensely help in the ongoing efforts at the preparedness for the next pandemic. Not surprisingly, the paper about the reconstruction of the 1918 Spanish flu, "Characterization of the reconstructed 1918 Spanish Influenza Pandemic virus" published in the October issue of Science and "Characterization of the 1918 influenza virus polymerase genes" published in the Nature were awarded as the Paper of the year, 2005 by The Lancet. Balaka Aggarwal in New York ]]> <![CDATA[CyberMedia launches Asia edition of BioSpectrum from Singapore]]> https://biospectrumindia.com/news/95/5271/cybermedia-launches-asia-edition-of-biospectrum-from-singapore.html https://biospectrumindia.com/news/95/5271/cybermedia-launches-asia-edition-of-biospectrum-from-singapore.html Tue, 11 Apr 2006 16:13:00 +0530 CyberMedia launches Asia edition of BioSpectrum from Singapore CyberMedia launches Asia edition of BioSpectrum from Singapore CyberMedia, South Asia's first and largest speciality media house launched its newest title BioSpectrum Asia in Singapore during the BioSingapore Forum Annual General Meeting, Singapore's leading Life Sciences industry event, on March 23, 2006. Leading personalities from the academia, and life sciences industry attended the launch event. His Excellency, High Commissioner of India, Alok Prasad was the guest of honor for the evening. Among the special guests were Dr Foo Fatt Kah, Venture Partner of Aravis Maida Vale, Michael Schroter, managing director of Lily Systems Biology Pte Ltd, and key industry representatives from logistics, pharma and biotech companies in Singapore. The magazine was launched jointly by the Indian High Commisioner, Alok Prasad, Steven Fang, CEO of Cygenics and chairman of BioSingapore, Roland Lim, executive director of BioSingapore, Pradeep Gupta, chairman, CyberMedia, and BioSpectrum Asia editor, N Suresh. Speaking at the launch of BioSpectrum Asia, Alok Prasad, High Commissioner of India in Singapore said, "I am happy that CyberMedia has chosen Singapore as the venue to launch its first global venture in life sciences. Singapore has been positioning itself as a regional life sciences hub, and it serves an ideal launch pad for BioSpectrum Asia to reach out to an international audience." Stressing on the importance of life sciences, he said Asia is playing a crucial role in shaping the international order, and life sciences is a key sector that can give it a competitive edge. "Both Singapore and India share synergies in the areas of popular culture, media and science and technology. The launch of BioSpectrum Asia in Singapore has not only established this fact but also has reinforced the Comprehensive Economic Cooperation Agreement that was signed last year opening up more opportunities for Indian companies to set up shop in Singapore," Prasad added. Pradeep Gupta, chairman and managing director of CyberMedia (India) Ltd, the publisher of BioSpectrum said, "Through this magazine, BioSpectrum, India's first and only exclusive biotechnology business magazine has extended its footprint to cover the path breaking happenings in the Asia-Pacific region. We decided to launch the magazine in Singapore as it gives us a unique platform to address a cosmopolitan audience in the Life Sciences arena. The launch of BioSpectrum Asia, earmarks another of CyberMedia's ongoing global expansion initiatives." As the world's economic fulcrum gradually shifts towards Asia, there is an increased focus on the exciting happenings in different industrial sectors. In the 21st century, life sciences has emerged as one of the most promising segments in terms of growth as well as providing benefits to a vast number of people in the world. "In addition to the bi-monthly print magazine, the exciting developments in the life sciences sector in the world's fastest growing region is already being delivered to industry leaders in all the Asia Pacific countries through a fortnightly digital magazine and a news-based website (www.BioSpectrumAsia.com), under the BioSpectrum brand name from Singapore," said Shyam Malhotra, Editor-in-Chief, BioSpectrum. BioSpectrum Asia will provide useful insights into the exciting areas of pharmaceuticals, biotechnology, medical devices, and research highlights and policy announcements from around the world, which will be of use to the life sciences business leaders in the region. Life sciences is the term used to refer to pharmaceuticals, biotechnology, medical devices and healthcare services. While Japan has always had a major presence in life sciences, including the world's second largest pharma industry, in recent years, China, India, Taiwan, Korea, Australia and Singapore have emerged as significant players in this arena. The global life sciences industry is estimated to be worth about $2 trillion. The Asia-Pacific region accounts for nearly 20 percent of the sector even though it is home to nearly 60 percent of the world's population. But this region is fast catching up with double-digit growth rates. If healthcare services are excluded, the life sciences sector will be approximately $1 trillion. And the Asia-Pacific region has nearly quarter of the share of life sciences excluding healthcare. Krishna Vilasini Bharadwaj in Singapore ]]> <![CDATA["DBT is an enabler of technology while supporting science"]]> https://biospectrumindia.com/news/95/1595/dbt-is-an-enabler-of-technology-while-supporting-science.html https://biospectrumindia.com/news/95/1595/dbt-is-an-enabler-of-technology-while-supporting-science.html Tue, 11 Apr 2006 16:11:00 +0530 New Page 1 "DBT is an enabler of technology while supporting science" Dr MK Bhan, DBT secretary, speaks about the year gone by, the Department's future role and new initiatives/challenges in the coming year, in an exclusive interview with Rolly Dureha of BioSpectrum. How does the DBT envisage its role in the future? The DBT views its role as a general enabler in the development of biotechnology. We already know how to function like a science agency. The question is how do we become a technology-developing agency. Since there are no preset norms, we have to be realistic. Our agenda will be: one, to enhance the ability of public sector institutions so that they make a more effective contribution to the technology development; and second to recognize that the larger possibility of technology development must come from the small and medium industry. We have to work on both fronts and try to converge them. The DBT will always support basic biology. It will support curiosity driven research because without that solid base, the thrust in innovation is not possible, important discoveries are not possible and someday we have to learn to do that. Now the question is that how do we go about supporting innovation, translation and product development? For this we need to increase the chances of the public sector institutions to do translation, without destroying their science base. This is the first challenge. The next challenge is to enable the Small and Medium Enterprises (SMEs) as a whole-encourage the small and medium industry to take more risks, pursue more challenging ideas and support them to do more late stage development for whatever proof of principle has been generated. How is the Department going to support the large, medium and small-scale industry? The SMEs need risk taking capital and early stage research support. Now with the Small Business Innovation Research Initiative (SBIRI) scheme already in place, we have funded about 12 companies this week. From now onwards we will expand the scale of this program. In the next plan we are hoping to scale up the funding to about Rs 100 crore or so per year, so that it will become a major source of support. The SBIRI is a very unique scheme where we are funding the industry directly. We intend helping out the large industry in a different way. We shall offer support by way of regulations, bringing scientific scrutiny of research, for example, Reliance Life Sciences, Mumbai is working on cancer vaccines and DBT will partner with them very strongly by bringing good scientific review for their work, problem solving help, contacts with world class people within this arena so that the scientists are not working in isolation but are surrounded by a wealth of experience and mentorship. Secondly when the industry is dealing with an outstanding technology, a real innovation, then the DBT is going to help in late stage development, wherever the public sector institutes are concerned. For example, if for a vaccine, a trial in a public sector institute is required than we will be happy to facilitate that and make some kind of contribution. So our philosophy for the large companies is to provide them with scientific support, science meetings, clinical validation and training. And most importantly surround the innovative and challenging industry projects with science and technology expertise and bring mentors closer to them. Then in the case of technology transfer projects, where the technology transfer involves international companies/scientists, the DBT will step in as a third party, as an enabler. Thirdly we are now bringing the industry as a regular participant in all our science meetings. For example in the new science collaborations with the UK, Finland, Denmark, Norway, we took the industry with us as part of the delegations, which has facilitated their striking agreements right away. This will be the enabling support from our end. In addition, we want to institutionalize this whole partnership by creating an industry research support cell-a research cell that is purely focused on the R&D of small and medium companies as a total support structure. This structure will also partner with Association of Industry Led Enterprises (ABLE) and make ABLE stronger. The same cell will now streamline India's participation in biotech fairs abroad, in making contact with industry leaders abroad, which means, building total relationship. I think one of the biggest challenges for us is to build relationships with the global industry. The research cell and ABLE will work on this front. We shall shortly start different types of fellowships to support people who are working in the industry. There will soon be 20-30 different schemes in the offing, which will basically ensure that the SMEs will not feel isolated but always feel supported by the government in its endeavor for innovation. So what is emerging is a wholesome industry package, which is larger than money. It is important to see the totality of the concept because the DBT realizes that it must be an enabler of technology while supporting science. It cannot do stand-alone technology development. How is the DBT planning to strengthen the institutional sector? As an enabler of translational research in the public sector institutions, we will expand our existing support for science education and training. And since many of the existing institutional structures are not adequate for translation, we will support creation of innovation centers, which are structured to suit needs of translation and translational research. For this we will offer support to universities, IITs and the research institutions. Currently we are in a major dialogue with the IITs. One of the most important things that the DBT can do is to increase effective contact and engagement between engineers, physicians, chemists, biologists through special granting schemes, interdisciplinary centers of excellence-virtual, in single institutes or across institutions. An example of this is the grant that has been given to CMC Vellore. This year we propose to give at least 5-6 more grants of this nature. Some of the priority areas for such grants are: virus research, embryonic stem cell research, nano agriculture and nano medicine, rational drug discovery, human and animal vaccine, future diagnostics, marine and seri biotechnology, agri biotechnology and industry processing. So we will form innovation centers on a competitive basis in a number of areas. Our Centers of Excellence (CoE) scheme will be revised now and will be of two types: One where it is purely a creation of CoE around people who have been outstanding and are still young enough; And the other in areas where we believe that CoE are required and must be pushed down in a top down manner. Both the schemes will coexist and will run every year. We plan to allocate about Rs 60 to 100 crore per year for the CoEs scheme. This year we have earmarked about Rs 60 crore for the scheme but will increase the budget for the next plan. We will provide building support, new faculty, the whole range of support system and all this will be outside the department structure so that the ambiance is more suited to translation. We hope that in the next 5 years, we will create about 30-50 CoEs in the country. In fact, for translation we now have two tracks of overseas fellowship. One where we simply send the best people abroad and they pursue the area that they want. The second is what we call a "niche area oversees training scheme" via which we create a critical mass of people in new areas like stem cell research, animal health, animal nutrition, medical genetics and so on. So wherever there is lack of human resource, we will start a scheme there. Notably, here merit will not be the only criteria, for example, suppose we have funded a center of excellence somewhere, then we will preferentially send their people for training. It will be a case of marrying the infrastructure with competent people. We have also been giving large infrastructure grants to the institutes. The other scheme that we have started in the area of translational research is giving grants for five years instead of three, wherever appropriate. This is because translation requires several related projects to be done and takes a longer time. So such research projects will be funded for a duration that is appropriate for the project rather than by a rigid predetermined period. Quality human resource is a concern for the industry. How is the DBT planning to strengthen this area? Starting from 2007, the DBT will support Masters in health sciences, PhD in health sciences and Masters in clinical sciences, as we do not have physician researchers. This will be in addition to the conventional MD and PhD programs. One may ask as to what is different about this approach? Actually it gives a variety of options to choose from in a medical institution-a kind of a cafeteria approach. For example, the Masters in health sciences program will be run on the lines of an executive MBA where existing young faculty can improve their science capacity, in transition, through the program that is run during the summer vacations, evening classes and Sunday classes. The program will suitably compensate the best teachers so that they find it attractive to teach at these unusual hours. The idea is to have a range of options/approaches and allow the people to choose from them. The key here is that there will be a reward for every clinician who decides to learn science-a financial reward for that period and there will be a reward for teachers who are willing to do this extra job. And eventually we will work on a strategy by way of which we can create more jobs for the physicians. Somewhat similar schemes are being discussed for the environment, agriculture, marine and other different sectors where they are very strong in their core disciplines but need more understanding of science and modern biotechnology. This year we have evolved the system for the medical professionals and now we are working on the other areas. This requires a lot of consultation with the user department. The core of the strategy is to create a pool of jobs, as there is no point of creating people in an area if the institutional career structure does not exist. Another initiative is that we will give summer project support in diverse fields (medicine, life science) on a very large scale. This is based on the feedback from a lot of scientists that early exposure to research thinking is of profound importance in the formative years. We will promote this in a big way, irrespective of disciplines, under a mentor. Students will be able to take a 2-3 month project during their summer vacation and some of these may extend and continue beyond this time frame. Eventually great scientists are not the ones with the greatest grades but they are people who have experience in pursuing intellectual curiosity and if they are temperamentally driven to it, then they will be hooked to research. This can be done only in the formative years. Our focus is also to improve the skills of teachers so that they can bring in experimentation at the undergraduate and postgraduate level more effectively. We plan to launch this exercise on a large scale and are looking for places to locate the teacher training schools. We are also working on the idea of having one high quality life science college in every city. This has to be very comprehensive as it means teachers training, infrastructure, visiting faculty, industry visit, summer project-convergence of all these ideas in one place. So that there is a symbol of world high-class life science within the country. We have started the "Institutional Innovation Grants Scheme", whereby we are willing to consider proposals for innovation grants managed by the institutes themselves and not the DBT for students at all levels. There has been a substantial increase in fellowships-PhD fellowships, post doctoral fellowships and we will go on increasing them. There is no limit to the number as long as we keep on getting good candidates. We have sent a proposal to the government for the creation of a national pool of jobs for life sciences. We have asked for 500 jobs and are currently waiting for an approval. In addition, we are starting a number of fellowships that will give performing scientists additional income and we will do this on scale. Because I think to keep people in science, particularly in translation, the financial rewards must be higher. So we will introduce a number of incentives in that direction. What are the new life science institutions in the pipeline? The Planning Commission has already approved a translational health science institute in Faridabad and a UNESCO center for training and education in Delhi. The translational health science center has three independent translational units-vaccine development and vaccine related research, diagnostics, bio based drug development, infectious disease research and a clinical trial center. The clinical trial center will be open to almost all industry efforts. A major help, which the companies need now, is good quality trials at low cost and this translational health center will assist in providing that. The translational health science center will also have a center for technology health policy, which will shape ideas on what technologies are needed and can be created. It will not do technology development but will look at the technology in the broader policy frameworks of public health needs, patient needs, market aspects, ethical aspects and a number of such areas. We are thinking of taking over the Seri Biotechnology Center of the Central Silk Board and run it like an autonomous body. We are also taking over a biotechnology institute in Kerala-the Rajeev Gandhi Center for Biotechnology in Thiruvananthapuram. Recently the Scientific Advisory Committee to the Prime Minister has recommended the creation of an animal biotech institute and we are working on it. The other idea under discussion is the creation of an agri biotech cluster in Punjab in which agriculture and food biotechnology institute and a biotech park will be developed in partnership with Canada. How will the National Biotechnology Regulatory Authority be structured? The government is having a serious discussion on the creation of a single biotechnology authority. The modalities of how it will be created and managed are under consideration and maybe in a month or two we will get the Cabinet decision on that. How are the international programs of the Department progressing? The international programs are getting a major revamp. What is now distinctive about the international programs is that the financial commitment from the international partners is clear and substantial. Each partnership is doing $10-15 million a year and they are all on equal footing. The contribution of the collaborating partners is matched by that of the DBT. We are integrating the international programs with the national programs and are making them more focused, for example our program with Norway will concentrate on human vaccines, animal vaccines and fisheries. Similarly the programs with Denmark, Finland, UK, Australia-all have a distinct focus so that these international partnerships are seen in the context of the overall national efforts of DBT. For example we have started a program for tailor made biotechnologies for agriculture that are of local relevance, not necessarily of national or global importance, in association with the Netherlands and this is a very farmer centric program. Here we will look at local needs and technologies that will benefit the local people. Earlier the international programs were more free floating and there was a certain disconnect between them and the national programs. Now they are less driven by political considerations and more by science and economic considerations. All the international programs are on a public-private platform, so there is good participation from the both the industry and the academia. In fact, they are now becoming a major R&D effort of the DBT. What have been DBT's efforts in the stem cell arena? What are its future plans? We have the ICMR-DBT guidelines and have got a fairly effective program on adult stem cells. We have also got an effective mechanism of assessment of proposals which takes into account ethics, science and clinical study aspects through three independent committees and all embryonic stem cell proposals will go through a combined interministerial interagency committee. So a system is put into place. We have provided GMP training to many medical schools. We have regularly organizing science meetings and have brought the best international people for these meetings, with the help of the overseas scientific advisory committee. We are hoping to fund an embryonic stem cell institute or center this year if we get an attractive proposal. Now a major grant has been given to the National Brain Research Institute (NBRC), Gurgoan, for embryonic stem cell work particularly relevant to neurosciences. We hope that the National Centre For Cell Sciences (NCCS), Pune, will come up with a proposal for a cell and tissue engineering center. Our effort has been to build capacity, build human resources, make more progress in ideas, promote and partner with industry wherever necessary and now build the institutional base as well. CMC Vellore is focusing on adult stem cells and we hope that the National Centre of Biological Sciences (NCBS), Bangalore and NCCS, Pune will come up with proposals for independent centers on embryonic stem cell research. The NBRC, Gurgoan, has picked up and eight of their proposals have been funded as a program support. Hence we are moving in that direction. On the whole, the embryonic stem cell arena is still very weak and we hope to make a dent this year by funding at least one-two more CoEs. The area is picking up, but there are still weaknesses and we need to incrementally work on them. What have been the achievements of the DBT in the last one year and what are the current challenges? We are happy that the Mashelkar Committee Report is on and will be implemented from April 1, 2006. Along with this major achievement, we have fulfilled the other commitments that we had given last year-about industry financing through SBIRI, then whatever reform was possible in regulation have been done. So we are happy that we have delivered on our promises. It is important to note that many of the schemes, due to the long approval time, were approved only by October 2005 and yet the officers at the DBT had released everything by January/February 2006. We must complement their hard work as by March 31, we had each of the schemes already out. There has been a great pressure on us. Over all it has been a great year of learning. I think that the challenge for next year is setting a large animal facility and also a transgenic animal facility, a single biotech authority by whatever mechanism it is created. Another concern is that we have spread our institutions very far and wide but our clustering efforts have not been good enough. We need to constantly work towards building around institutions, complementary facilities and structure. We are now much more focused on one change that has come in our system that we want to fund fewer projects for product development. But the ones that we fund, we want to go really after them, in terms of resources and effort. So our thinking has become a little more like the industry in that sense. On the whole it has been an interesting year. ]]> <![CDATA[Indian Peptide Society launched]]> https://biospectrumindia.com/news/95/1389/indian-peptide-society-launched.html https://biospectrumindia.com/news/95/1389/indian-peptide-society-launched.html Wed, 15 Mar 2006 10:57:00 +0530 Indian Peptide Society launched Indian Peptide Society launched Looking at the significant role of peptides in the biopharmaceutical arena, the Indian Peptide Society has been set up under the presidentship of Prof VS Chauhan, director, ICGEB. The aim of the society is to provide a platform and common forum to the scientists working on peptides in India. Later on, establishing links with the other peptide societies across the globe like the American Peptide Society and Japanese Peptide Society is on the cards. "Peptide research is on the verge of evolution in India and peptide pharmaceuticals will be coming in a big way. There is a global shift from genomics to proteomics and there is big peptide demand in the area of vaccines", said Rakesh Arora, secretary of the society and director, TechnoConcept India. Prof P Balram, director, IISc has been nominated as the vice president of the society. During the latter half of the year, the society plans to convene the "Indian Peptide Symposium" in Hyderabad which will target the industry, academia and students interested in this arena. The society is headquartered at the International Center for Genetic Engineering and Biotechnology (ICGEB), New Delhi. TechnoConcept launches custom peptide synthesis service TechnoConcept, which provides consumables, instruments and scientific software to the life sciences industry, has launched a custom peptide synthesis service. It has established a facility at NOIDA, which is equipped with automated synthesizers, chromatography system and other equipment. The peptides are synthesized using solid phase and solution phase chemistry by employing Fmoc and t-Boc methodologies for the design and production of peptides for research purposes. TechnoConcept offers a range of peptide services from small research scale to large-scale synthesis. According to Rakesh Arora, director, TechnoConcept, "We try to understand the need of the customer and along with standard peptides we also provide non standard peptides. Our unique facility will work as an import substitute in the future." The company offers standard peptides and those with various modifications-terminal modification, Side modification, unusual amino acids and many others modifications, Labeled peptides, MAP peptides, etc. For most peptides, the turnaround time is about 3-4 weeks. "To ensure quality guarantee, every purified custom peptide from its lab is analyzed by Mass Spectrum and HPLC. Our long-term aim is to establish GMP grade peptide synthesis", Rakesh added. Wockhardt's profit up 20 percent at Rs 257 crore Wockhardt Ltd has reported a 20 percent increase in net profit at Rs 257 crore for the year ending December 31, 2005. Consolidated annual sales, at Rs 1,412 crore, showed a 13 percent growth over 2004. The audited results for the year were announced after a board meeting on February 14, 2006. The board recommended an annual dividend of 100 percent subject to shareholders' approval. Operating profit for the year increased by 17 percent to Rs 329 crore and operating margins improved by 80 basis points to 23.3 percent. Wockhardt invested Rs 104 crore, amounting to 7.4 percent of the turnover, in R&D during the year. For the quarter ending on December 31, 2005, net profit stood at Rs 73 crore, posting a 16 percent improvement over the corresponding quarter of 2004. "Our investments in organization and people in two critical growth areas are now paying back â€“ our US business has grown by more than 50 percent, and the biotechnology business has grown by 54 percent," said Habil Khorakiwala, chairman, Wockhardt. Mascon launches EXOME-Horizon Mascon has launched EXOME-Horizon-a complete bioinformatics solution platform. EXOME is an integrated system for bioinformatics and has bioinformatics software suites required by high-end biological research labs. From suites for large genome analysis to automated drug design, EXOME is designed to be the one-stop solution for biocomputing needs. The package combines the robust Linux platform with customized, high performance hardware to facilitate efficient analysis of large amounts of data. The tool is an enhanced and customized distribution of Fedora (a Linux distribution) for bioinformatics research and education. In addition, it includes the capability to adapt to HPC (High Power computing) requirements and contains all major bioinformatics software. EXOME- Horizon uses client server architecture, which means that while the databases etc. run on a Linux server, multiple users can access the tools and databases, from either Linux or windows machines (browser based access). EXOME- Horizon contains hundreds of bioinformatics programs and software and it has been designed in such way that it can be customized for individual client requirements. Panacea Biotec raises $100 million via FCCB issue Panacea Biotec has concluded its $100 million foreign currency convertible bonds issue on February 13, 2006. The five-year bonds are split into two equal-sized tranches and the company plans to list them on the Singapore Stock Exchange. Tranche 1 was priced with a 4.5 percent semi-annual coupon and was sold at par. It will be redeemed, with a yield to maturity of 4.5 percent. Tranche 2 was also sold at par, with a zero coupon, and a yield to maturity of 7.25 percent. United Phosphorus snaps up Dutch firm United Phosphorus Ltd, India's largest producer of crop protection products with a wide range of products that include fumigants, fungicides, insecticides, rodenticides and herbicides, has acquired through its subsidiary Biowin Corporation Ltd in Mauritius, Advanta Netherlands Holdings BV, based in Netherlands. The acquisition will be effective from February 14, 2006. This acquisition will allow United Phosphorus to have a jumpstart entry in the high end of seed business, says a press release. This is likely to provide a strong platform to the company and make it a leader in many important products. Ethypharm announces out-licensing deal with Colombian company Ethypharm, a leading French multinational drug delivery company has announced the finalization and signing of a new out-licensing and supply contract for the Colombian market with Euroetika Ltd, a leading Colombian drug company. The products will be supplied by its wholly owned subsidiary Ethypharm LL India. The deal is for three products: Tizanidine Sustained Release â€“ a skeletal muscle relaxant, Metaclopramide Sustained Release â€“ an antiemetic and Levocetirizine Orodispersible tablets â€“ anti histamine agent. The products would be supplied from Ethypharm's manufacturing facility near Mumbai as penultimate stage bulk formulations and converted to finished formulations in Colombia under technical supervision from Ethypharm. Euroetika Ltd is also an existing customer of Ethypharm for other Novel Drug Delivery System (NDDS) products. The Colombian market was approximately $1.3 billion in 2004 as per IMS data and is growing at approximately 12 percent. "This deal would consolidate Ethypharm's already significant presence in the South and Latin America markets," said Ajey Kumar, CEO of Ethypharm LL India. SIRO Clinpharm, GCP Siro offer services to US Pharma and Biotechs Siro Clinpharm, a leading CRO has entered into a formal agreement with GCP Siro of USA to offer a US Clinical Research Organization specializing in the management of late-stage clinical studies using proven capabilities in India. With this agreement, SIRO Clinpharm will be expanding its global presence in the CRO space. "Pharma and biotech companies can now utilize Indian clinical trial investigators, patient populations, and other expert resources for their global registration trials without adding overheads or internal project management costs. GCP Siro provides the necessary US-based project management, client liaison and other direct drug development support services," the release said quoting Dr Mark Bradshaw, president, GCP Siro. Dr Gautam Daftary, founder of Siro Clinpharm, said, "The highest level of scientific integrity, world-class quality, and a focus on client service are the cornerstones of Siro and GCP Siro. Led by a senior US pharmaceutical executive with significant first-hand experience in India, GCP Siro guarantees compliance with the principles of Good Clinical Practice (GCP) and full US and India regulatory requirements." Sun Pharma board clears demerger scheme The Board of Directors of Sun Pharmaceutical Industries has approved the demerger of the company's innovative R&D, namely the NCE and NDDS programs, to a new company with the same equity holding pattern. The difference between generic reverse engineering and innovative R&D in terms of risk profile, longer time frames and considerably larger resource requirements in the future, were cited as key reasons for the split. Dilip Shanghvi, chairman and managing director of Sun Pharmaceutical Industries would be the chairman of the demerged company. The demerged company will be listed on the BSE and the NSE after the requisite clearances. In addition to an approximately 100 person staff of scientists, running programs in NCE and NDDS, assets including cash and equipment would be transferred to the demerged company. The board ratified demerger scheme proposes April 1, 2006 as the effective date of the demerger. As part of the scheme, shareholders of Sun Pharma would be allotted an equity share of Re 1 each for each share of Rs 5 of the parent company, held on the record date. Arun & Co to introduce mineral enriched yeasts in India Arun & Co, a frontrunner amongst biotechnology suppliers with diversified interest in industrial biotechnology, diagnostics, molecular biology and pharmaceuticals, will introduce mineral enriched yeasts by March 2006. It has entered into a tie-up with Institut Rosell / Lallemand Human Nutritions, Canada, one of the leading probiotics and mineral enriched yeast manufacturers in the world. Recently Selenium Yeast of "Lalmin" brand from Institut Rosell / Lallemand was chosen as certified reference material by the National Research Council of Canada fortifying the growing trust in mineral enriched yeasts by developed countries. Rashesh Doshi, director, Arun & Co said, "Yeast enriched with minerals is the latest trend in the international nutraceuticals market with many recent studies having confirmed the superior bioavailability of yeast minerals versus synthetic sources such as gluconates and chelates." Mineral enriched yeasts are known as biological source of essential trace elements. They are normally inactivated whole cells of Saccharomyces cerevisiae rich in minerals containing elevated levels of Se, Zn, Cr and Fe. ]]> <![CDATA[BioIT: Looking for vertical growth]]> https://biospectrumindia.com/news/95/2686/bioit-looking-for-vertical-growth.html https://biospectrumindia.com/news/95/2686/bioit-looking-for-vertical-growth.html Wed, 15 Mar 2006 10:50:00 +0530 BioIT BioIT: Looking for vertical growth The Indian bioinformatics market that registered about Rs 100 crore in 2005 has been growing rapidly. The three years average growth of Ocimum Biosolutions, a Hyderabad-based life sciences R&D enabling company with competencies in BioIT, Microarrays and Contract Research Services, reveals the market potential for the Indian bioinformatics companies. Ocimum Biosolutions, which has registered 823 three-year percentage growth has been ranked 55th amidst the 500 fastest growing technology companies of repute across the Asia-Pacific region by the Deloitte Technology Fast 500 Asia-Pacific 2005 Program. It also has the distinction of scoring 4th rank in the Deloitte Technology Fast 50 India 2005 Award, again a program based on a three year average percentage revenue growth which ranks the 50 fastest growing technology companies by geographic region. And the agreement between Tata Consultancy Services (TCS), a leading global technology services company that developed the Bio-suite, with Congenia, a biotechnology start-up promoted by Italy's Genextra Spa group to provide advanced fragment-based lead optimization solutions for drug discovery proves India's Bio-IT strengths. It also indicates that the Indian bioinformatics companies are capable of fulfilling the requirements of the global biotech and pharmaceutical companies. Supporting factors India's entry into the product patent regime in 2005 has really boosted the bioinformatics sector. Since many leading Indian pharmaceutical companies are investing on R&D, drug discovery research is likely take an early lead in this new patent regime. IDC foresees that IT spending in biosciences in India will cross $138 million by 2005, mainly in the areas of system clusters, storage, application software, supply chain management, data protection and services. Also the government's life science focus provides a great deal of the necessary backbone to develop and deliver innovative products and technologies. This focus will also helps to build fast-growing and lucrative enterprises, attract international investment, and create additional high-value employment opportunities. According to Frost & Sullivan, the bioinformatics industry which generated revenues totaling $1.38 billion in 2000 in the United States alone; is expected to reach $6.9 billion by 2007.This forecast includes revenues from markets for hardware and software for genetic sequence data generation, stand-alone genetic sequence analysis systems, and genetic sequence data management systems. Companies actually involved in development of software tools, database solutions and others that only market these products take up the market share in Bioinformatics. We have the promising start-ups based at Bangalore, Hyderabad, Pune, Chennai, and Delhi. According to IDC, there are over 200 companies including the IT ones are functioning in this space. Government push With the improvements in the IPR regime, increasing support from the government and continuing efforts of the private sector companies, it is very much likely that India could repeat its IT success story in bioinformatics too. The government is also making efforts to support the segment by setting up BioIT Park. These parks would be a conglomerate of academic-industry-research initiatives, thereby opening up new vistas for the Indian Bioinformatics market and making it a sunrise industry for the future. The Department of Biotechnology, Government of India has been working with other departments to set up this park, which is expected to position India in the global hub of Bioinformatics. The Department of Biotechnology in its National Biotech Development Strategy has also pointed out some strategic action plans in the following areas - human resource development, infrastructure development, testing of public domain resources, inter agency coordination, strengthening of DICs and sub DICs and Bio IT parks and promotion of bioinformatics industries. These initiatives will support the segment to grow vertically and to take a major pie in the global bioinformatics sector in the next few years. This sector is the quickest growing field in the country. The vertical growth is because of the linkages between IT and biotechnology, spurred by the human genome project With the Government getting its act together, introduction of the product patent regime in January 2005 and the private sector stepping in, India is becoming an important player in genomics and bioinformatics. Considering the potential, it is expected to grow to $120 million by 2006 and likely to take a major pie in the global bioinformatics sector in next few years. ]]> <![CDATA[India among top 10 growers of biotech crops]]> https://biospectrumindia.com/news/95/1268/india-among-top-10-growers-of-biotech-crops.html https://biospectrumindia.com/news/95/1268/india-among-top-10-growers-of-biotech-crops.html Wed, 15 Mar 2006 10:49:00 +0530 India among top 10 growers of biotech crops India among top 10 growers of biotech crops In 2005, India accounted for the highest yearly percentage growth rate increasing its Bt cotton area by 160 percent. With this India became the seventh largest adopter of biotech crop, according to a report authored by Dr Clive James, chairman and founder of ISAAA, the International Service for the Acquisition of Agri-biotech Applications. India recorded three-fold increase, by planting 1.3 million hectares of Bt cotton in 2005 compared to 500,000 hectares in 2004. Around 10 lakh resource poor farmers elected to plant Bt cotton in the northern, central and southern cotton growing zones which is a three-fold increase over 2004. During the year, 16 new varieties of Bt cotton hybrids belonging to four companies (Ankur Seeds, Mahyco-Monsanto, Nuziveedu Seeds and Rasi Seeds) were released totaling to 20 Bt cotton hybrids. Three companies (JK AgriGenetics, Nath Seeds, Syngenta) received permission for large-scale field trials of biotech cotton with different genes in 2005. Presently, more than 25 companies are developing different varieties of biotech cotton hybrids with different genes and with staked genes/multiple traits i.e., cry1Ac, cryAb, GFM-cry1Aa, Vip-3a, cry1Ac+cry2Ab said the report. The University of Agricultural Sciences, Dharwad along with the Central Institute for Cotton Research (CICR), Nagpur is developing its own biotech cotton varieties employing Bt gene and is likely to be made available to farmers soon. The approval of more numbers of Bt cotton hybrids is likely to grow further in 2006 and researchers are exploring the future potential for multiple traits in biotech cotton. Summing up the global biotech crop scenario, the report stated that worldwide farmer demand has driven annual double-digit increases in biotech crop adoption since the crops were commercialized a decade ago. In 2005, four new countries and a quarter million more farmers planted biotech crops as part of an 11 percent increase in global biotech crop area. Since initial commercialization in 1996, global planted area of biotech crops has soared by more than fifty-fold from 1.7 million hectares in six countries to 90 million hectares in 21 countries in 2005. The 8.5 million farmers planting biotech crops in 2005 also marked a significant milestone as the 1 billionth cumulative acre or 400 millionth hectare was planted. Further there has been a lot of bioagri research happening in India. There has been work going on in transgenic brinjal, rice, corn, chicken pea, and several other food crops. If the policy to allow the transgenic foods is announced, the events are expected to turn even faster. ]]> <![CDATA[Clinical research market buoyant]]> https://biospectrumindia.com/news/95/2772/clinical-research-market-buoyant.html https://biospectrumindia.com/news/95/2772/clinical-research-market-buoyant.html Wed, 15 Mar 2006 10:47:00 +0530 Clinical research market buoyant Clinical research market buoyant The global market for clinical research is estimated to be $10 billion in 2005 and continues to grow at 12 percent per annum. India can garner up to $1.5 billion by 2010. The arrival of stronger intellectual property protection is changing the rules of the game. India has allowed product patents for drugs since January 2005 to make industry attractive and multinationals are looking towards India. India Clinical Research Market Size The Indian clinical research industry remains in infancy stage with 0-10 years of operation. The Phase I to IV clinical trials were started in 1995 by domestic firms such as SIRO Clinpharm and Apothecaries. Quintiles was the first international CRO to enter India in 1997. The year 1999-2005 saw a number of CROs setting base independently or through collaboration. With the global pharmaceuticals companies looking outward to reduce their ballooning research costs, India is in a good position to tap the new business opportunities. Quintiles Spectral, SiroClinpharm and Syngene are the 3 key independent CRO players in India accounting for 71 percent of the market share. The health system in India is at the cross roads, though dramatically changed from what it was a few decades ago. India has 1 billion plus population, largest patient pool, and 50-60 percent cost advantage in the clinical trials. At a time there are around 80,000 to 1 lakh clinical trials going across the world. Cost advantage is the biggest benefit that India provides, but there are still significant issues that need attention. Advantage India The key concern is the regulatory structure, GCP and ethical practice and skilled manpower. The changes in the regulatory framework are happening and gradually gaining momentum. The government is planning to take a number of steps such as single regulatory authority, forum for CGP, patient registry database, clinical trials website, speeding up the clinical trials application review process and infrastructure up-gradation to foster industry growth. In order to meet the skilled manpower shortage, CROs have started in house training programs and educational tie ups. BioSpectrum Advisory Services research indicates that a maximum number of CROs were started in 2004 and 2005. Some CROs have sufficient financial backing of the parent company. Bangalore and Mumbai are the favored destinations for starting clinical research operation with other parts of the countries also gaining attention. The clinical trials sites are spread across length and breadth of the country with large number of small cities also offering adequate clinical research facility. Clinical data management, statistical analysis, regulatory affairs, trials supplies management, training and auditing services are expected to grow faster. The industry will see niche players, capacity expansion and collaboration to fuel the growth plan. The introduction of the ethical guidelines for Biomedical research in human beings, acceptance of GCP guidelines, revision of Schedule Y (multi-centric Phase II and Phase III trials) and patent regime is making the industry attractive. We see India moving from low cost destination to full service provider where CROs offer services from the earliest stage of development through clinical trials and post approval research. India Clinical Research Industry 2004-05: $100-150 million 2010: $1000-1500 million More than 40 CROs located International certification achieved: CAP, ANVISA, MCC, ISO 9002 Further, with life sciences and pharmaceutical companies showing a definite inclination towards electronic technologies and investing substantial amounts in transitioning from paper-based to electronic processes, revenues in the eClinical trials (eCT) market are expected to increase from approximately $210 million in 2004 to $357.4 million in 2011. Sponsors prefer India over china because with the start of product patent regime in India MNCs are now looking towards India. Currently, there are more than 25 well-established clinical trial organizations in India with a well-developed skill set to comply with the standards such as ICH-GCP guidelines. ]]> <![CDATA[Industrial enzymes: High on radar]]> https://biospectrumindia.com/news/95/2591/industrial-enzymes-high-on-radar.html https://biospectrumindia.com/news/95/2591/industrial-enzymes-high-on-radar.html Wed, 15 Mar 2006 10:46:00 +0530 Industrial enzymes Industrial enzymes: High on radar The industrial enzyme sector in India estimated at Rs 320 crore in 2004-05 registered 34.45 percent growth during the year. There are about 17-20 players. Most of these companies are either into marketing or into formulations. But there are companies that are into real manufacturing of enzymes used in different industries like pharmaceutical, food processing, leather, detergents, paper and pulp and textile. They produce various enzymes and several other eco-friendly biological products. The product range and services are growing rapidly as the use of enzymes is gaining widespread acceptance. The Indian manufacturers are not only supplying to local market but are also exporting to number of countries. Maps India, an Ahmedabad-based biotechnology company producing enzymes and microorganisms since 1975, has spread its network to 20 countries with a product portfolio of 60 plus meeting the requirements for more than 10 different industries. Similarly Advanced Enzymes Technologies (formerly called Advanced Biochemicals) based at Thane near Mumbai has extensive biotech experience that has led to the development of hundreds of unique enzyme solutions addressing the needs of customers in 25 industries and over 30 countries. The companies are also expanding their manufacturing bases to meet the local and global demand. Maps India is investing Rs 10 crore for production of new enzymes and microorganisms. Advanced Biochemicals is setting up a 100 percent Export Oriented Unit and is investing over Rs 110 crore at Indore SEZ. The opportunity in enzymes sector is attracting companies from agri and pharmaceutical sectors like Excel Industries and Concord Biotech (manufacturers of statins) to invest in this sector that is free from complex regulatory issues. | On the other hand, we have the presence (directly or indirectly) of the some of the global players in enzymes space like Novozyme, Genencor International, Enzyme Development Corp., Dyadic International and Quest International. These are keen on to tap the local market here. For example, Genencor, a global leader in the enzyme market and having indirect presence in India since 1996, has entered the market on its own. It has taken a few people on board. While Novozyme had already set up its own office in Bangalore, Danish company CHR-Hansen opened shop in Mumbai to market its enzymes products used in the food processing industry. Focus on R&D Advancements in biotechnology and genomics would aid the discovery of fresh enzyme sources and production strains for commercialization. Companies like Rossari Biotech and Advanced Enzyme Technologies have been investing on their R&D activities. Also academic and research institutes like the Institute of Microbial Technology, Chandigarh, National Chemical Laboratory, Pune and Indian Institute of Technology (IIT), Delhi are already working on some R&D projects in the industrial enzymes segment. Instead of working independently, if both the public and private sectors work together they might take on the MNCs in launching new and indigenous products. As noted earlier, the industrial biotech sector is relatively free from regulatory complexities of biopharma and bioagri sectors. Nonetheless, it is being felt that the current situation tends to favor traders as against manufacturers. DBT has taken this into account and has included a road map in its draft on the National Biotechnology Development Strategy to promote and develop the sector. The few strategic actions mentioned include emphasis on industrial biotechnology to reduce chemical and toxic load in effluent streams, developing non-fossil fuels that are eco-friendly and developing green technologies in industrial processing and encouraging public-private partnerships to promote investment in this sector. Further, it has been suggested to promote industrial biotechnology as a strategic area of manufacturing and developing green technologies. Potential In 2004, the global demand for industrial enzymes was $ 2.5 billion with an annual growth rate of 5-10 percent. The USA, Europe and Japan together account for over 90 percent sales of the enzyme in the world. The global demand for enzymes will grow 6.5 percent annually through 2009. Specialty types will generally outpace industrial enzymes, though the market for animal feed enzymes will grow the fastest. Developing countries such as China, India, South Korea and Taiwan will offer some of the best growth opportunities. Although the growth in enzyme sector globally is expected to be about 7 percent, in India it is on the higher side. Growing consumption of enzyme in the existing application areas, use of enzymes in the new industrial processes, strict enforcement of environment laws and cost savings would support the growth of this sector in India. With least entry barriers and no social and regulatory risks involved in industrial biotechnology, the Indian companies that develop enzymes have a good future and would cross Rs 1000 crore mark in the next couple of years. ]]> <![CDATA[$5 billion by 2010 a possibility]]> https://biospectrumindia.com/news/95/1961/5-billion-by-2010-a-possibility.html https://biospectrumindia.com/news/95/1961/5-billion-by-2010-a-possibility.html Wed, 15 Mar 2006 10:44:00 +0530 New Page 1 $5 billion by 2010 a possibility In 2004-05, the biotech industry recorded Rs 4,745 crore in sales revenues, crossing the $1 billion mark. With $1 billion milestone achieved, the big question is what will be the next milestone. Would it be $5 billion? Would it be a company from India, which will be among the top 10 ranked biotech companies in the world? Will anyone from India win a Nobel Prize? Will it be a new drug discovery from India? BioSpectrum, in this third anniversary issue, tries to find out what to expect at least in the next few years till 2010. First things first. What would be the size of the biotech industry in 2010? Going by the past track record of the industry, BioSpectrum feels that the biotech sector will reach the $5 billion mark in 2010. Going by the current growth rate of 33-37 percent year on year, the estimate is that industry in 2005 would be close to Rs 5,000 crore, in 2007-08 it may cross the Rs 10,000 crore, touch Rs 15,000 crore mark in 2008-09, and in 2009-10 surpass Rs 20,000 crore in revenues. There have been several murmurs within the industry about the $1 billion mark. In fact, some have attributed to the inclusion of biosuppliers in the survey. All the three BioSpectrum-ABLE Industry surveys have so far calculated the industry size excluding the sales of the biosupplier community. It is a tall order but it is definitely attainable if the industry, government and academia, all collectively work towards this mission. Kapil Sibal, Union Minister for Science & Technology and Ocean development, observed, "My dream is not just the $5 billion, but much more. Biotech is the sunrise industry of the country in the early part of this century and I think it will make it possible to take this country forward and achieve the growth rate of 8 percent of GDP that we have been talking." The BioPharma, BioAgri, Bioinformatics, BioIndustrial and the BioServices sectors will all be the key components in the growth of this industry. The BioPharma sector is estimated to grow to Rs 8,000 crore by 2010, the Bioservices to Rs 5,000 crore, the BioAgri to Rs 5,000 crore, BioIndustrial to Rs 1,500 crore, and Bioinformatics to Rs 1,000 crore. In 2003-04, there were just four companies with revenues in excess of Rs 100 crore. In 2004-05, there were six. And by 2010, there would be nearly 75-100 companies with revenues in excess of Rs 100 crore. The total number of biotech companies in the country is expected to grow to 800 by 2010. At least five companies can be predicted to cross the Rs 1,000 crore mark by then. Indian biotech companies are predicted to make a global name for themselves too. At least two biopharma companies-Serum Institute and Biocon-are positioned to be in the top 10 biotech global companies. The CRO sector too can see a few Indian companies in the Top 10 CROs-Jubilant Biosys and GV Bio. Reliance Life Sciences is another company to watch out. By 2010, India is going to see several good clusters. According Dr MK Bhan, secretary, DBT, at present, cities like Bangalore, Hyderabad, Pune, Mumbai and even Chennai, to some extent, have developed as biotech centers. Then there are some efforts that have been initiated in a number of other places like Kolkata, Gujarat, Orissa, Himachal Pradesh and Rajasthan. Besides these city-based clusters, there can also be nation-based clusters and there are two that Dr Bhan would love to do on a national scale-one on stem cells and another on proteomics, where the partnerships/networks are across the states. BioSpectrum is optimistic that by 2010, the biotech industry in India will have a changed contours compared to that in 2005. ]]> <![CDATA[Players see good potential for hybridization ovens]]> https://biospectrumindia.com/news/95/2890/players-see-good-potential-for-hybridization-ovens.html https://biospectrumindia.com/news/95/2890/players-see-good-potential-for-hybridization-ovens.html Wed, 15 Mar 2006 10:40:00 +0530 Players see good potential for hybridization ovens Players see good potential for hybridization ovens A lot of basic research is going on in India but the market for hybridization ovens is yet to pick up. With their range of quality products, multinationals are scoring over local companies. Hybridization ovens are fast becoming the preferred method of hybridization technique in today's laboratory. Incubations take place inside the oven, under constant rotation, providing even distribution of probe solution over the membrane. While there are other solutions available for hybridization applications, hybridization ovens offer better agitation, higher throughput and require less volume per membrane area, resulting in savings. Hybridization oven has various applications in research activities such as molecular biology assays, southern (DNA) hybridizations, northern (RNA) hybridizations, western blot, gene separation, gene expressions and gel documentation. There are a couple of companies in India which are manufacturing hybridization ovens to meet the local needs. But most of the requirement is met by multinationals that are marketing their products through distributors/dealer network in the country. Neolab Instruments, Shambhavi Impex, Nu Tek Instruments are a few local manufacturers who produce these equipment. Besides these companies, multinationals like Thermo Electron Corporation, Centurion, Amrex, Techny are selling these ovens through dealers in India. MediSpec Instruments India Ltd, a distributor for UVP in India, Spinco Biotech representing Affymetrix in India, Sigma Aldrich, Amersham Biosciences (now part of GE Healthcare) are the other few companies which supply hybridization ovens in India. "We were into manufacturing and marketing of hybridization ovens for over five years. But we discontinued with this product. We found out that there is no huge market potential and quality is one of the factors. Companies prefer products from multinationals against Indian manufacturers although we offer them at an affordable price. We used to sell 8-10 units a year," said GG Pillai, director, Pooja Lab Equipments. Vippul Chhatbar, managing director, MediSpec Instruments India Ltd, which is representing UVP in India, said, "There are hardly few companies in India which are into manufacturing hybridization ovens. About 80-100 units are sold in India. The local companies are finding it difficult to sell their products in this competitive market. Multinational companies with their quality products have actually capitalized on the market. These products are available in the range of Rs 1.5â€“2.5 lakh." Sharing similar views, Srikanth Lele, partner, Neolab Instruments said, "We do sell 1-2 units of hybridization ovens per month on enquiry. And I feel about 100 units are sold in all in a year. Although the locally available ovens are priced at one fifth of the price of a multinational product, still most of the life sciences companies/ research institutes prefer imported ovens. This I feel is mainly because of their better quality when compared with locally available products. India has been doing well in basic research. And this is picking up with more investments from public and private sector. Considering these points, there is a good market potential for hybridization ovens in the near future in India." However, K Iswara Dutt, managing director, Nu Tek Instruments Pvt Ltd, a manufacturer and wholesale supplier of scientific and laboratory instruments, hospital and medical disposables, educational items and other products, said, "We see a change in R&D activities in India in the last couple of years. And the now the market for hybridization ovens is picking up. It will grow at rate of 20-25 percent in the next five years. At present we see about 150- 200 units sold in north India. Locally produced ovens are available at Rs 40,000-50,000 per unit - one third of the cost of the imported ones. Research institutes, biochemistry labs, and biotech companies use these ovens. It will be a capital investment for these organizations." The Association of Biotech Led Enterprises (ABLE), a lobby group for the biotech industry in its pre budget recommendations to the finance ministry has requested for expansion of the list of capital goods under list 27A and 28 and easing of norms. ABLE noted that the concession presently provided to biotech companies permitting duty free import of equipment as per List 27A and List 28 by manufacturers having an R&D wing registered with the DSIR, to the extent of 25 percent of the FOB value of exports made in the previous year is not beneficial. Hence it recommended expanding the List of Equipments provided in List 27A and List 28 to cover equipment such as hybridizations ovens required for R&D activities besides equipments used in production. This will support the companies, which are into manufacturing and marketing of hybridization ovens. And the market will pick up in the coming few years.   Narayan Kulkarni   ]]> <![CDATA[Pooja Lab Equipments offers incubator shakers]]> https://biospectrumindia.com/news/95/1945/pooja-lab-equipments-offers-incubator-shakers.html https://biospectrumindia.com/news/95/1945/pooja-lab-equipments-offers-incubator-shakers.html Wed, 15 Mar 2006 10:39:00 +0530 Pooja Lab Equipments offers incubator shakers Pooja Lab Equipments offers incubator shakers Pooja Lab Equipments offers orbital shaking incubator with cooling and heating in different models. The orbital incubator shakers incorporate design features that operates quiet, maintenance-free shaking under in liquid medium with agitation under controlled temperature, growing cultures of micro-organisms, tissue cells and incubation of various enzymatic assays. All models features precision microprocessor based controls and efficient mechanical air convection for exceptional uniformity and control of temperature. Shakers incorporate brushless AC motors for prolong maintenance-free operation with AC drive. Threaded holes are provided on the universal shaking platform for fixing interchangeable lotus clamps for fixing different capacities of conical flasks. Interiors are corrosion resistance 304 SS and exterior is powder coated MS. All around the inner insures absolute insulation and energy conservation. Standard heating elements deliver long life heating and automatic over temperature safety limit prevents excessive temperature and possible damage to precious specimen or equipment. Uniform air distribution system sweeps the chamber walls to ensure constancy of chamber environment providing gentle airflow in the product area. Cooling system with hermetically sealed powerful compressor using latest CFC-FREE refrigeration technology. The unit is suitable for operation on 230 V, 50Hz, AC single phase and ambient temperature up to 37ºC supplied without clamps and illumination. For details, contact: poojalab@vsnl.com   Thermal cycler systems from Quanta Biotech Quanta Biotech offers three ranges of thermal cycler - the QB-24 Personal Thermal Cycler, the QB-96 Gradient Thermal Cycler and the fully automated Auto-Q Server and Satellite Thermal Cyclers. All Quanta's Thermal Cycler models are available in Server and Satellite formats. The server models can control up to three satellites in a mini USB network. The network can be expanded from 1-4 cyclers at any time providing flexible, cost effective and space saving solutions to fulfil any research laboratory need. Alternatively up to 15 satellites of any model can be driven directly from a PC providing mixed networks of manual and fully automated units with throughputs sufficient to satisfy the most demanding genome factory requirements including full robot integration where required. For details, visit www.technoconcept-india.com   TAKE Solution launches Submit SPL software Chennai-based TAKE Solution recently launched Submit SPL software. The software helps biopharmaceutical companies to easily manage XML data conversion to be compliant with the Structured Product Labeling (SPL) standard of the US FDA. TAKE's robust submit solution quickly converts the product information from any traditional format to the SPL standard-based XML format (used for submission) and also to PDF format for printing and viewing. The Submit SPL software also helps pharmaceutical companies mitigate the several potential risks associated with non-compliance of FDA regulations. The software's advanced publishing features and reusable components of product information make it possible to automatically publish package inserts, prescribing information, labels, product web sites and promotional material. The Submit SPL introduces efficiency in all elements of the data processing activity such as authoring, reviewing, approval, and publishing, and enhances the productivity of the authors and eliminates errors. Additionally, with Submit SPL, users are already ready to meet the future regulatory standards such as Product Information Management, which is being developed by EMEA. For details, contact: neera@takescm.com   GenomePlex Single Cell WGA Kit from Sigma-Aldrich Sigma-Aldrich has launched GenomePlex Single Cell Whole Genome Amplification (WGA) Kit. The new GenomePlex Single Cell WGA Kit supports whole genome amplification from a single cell, resulting in a million-fold amplification yielding microgram quantities of genomic DNA. Providing researchers with a product to amplify genomic DNA from a single cell will help to advance cancer research, genetic profiling and preimplantation genetic diagnostics. The GenomePlex Single Cell WGA Kit will ease the concerns of limited patient source material and provide sufficient DNA for downstream studies. This kit is the latest addition to the GenomePlex whole genome amplification family of products. The GenomePlex Single Cell WGA Kit can be used in numerous applications, and is suitable for use with a variety of cells, including fibroblast amniotic cells, renal cancer cells, plant, epithelial, leukemia, and polycarbonate fixed cells. After purification, amplified DNA can be analyzed in a manner similar to any genomic or chromosomal DNA sample. A number of downstream applications may be performed, including QPCR, STR analysis, SNP analysis, Comparative Genomic Hybridization (CGH), micro arrays, and other genotyping analysis. For details, contact: smohamed@sial.com ]]> <![CDATA[Praj records Q3 sales at Rs. 53.62 crore]]> https://biospectrumindia.com/news/95/2237/praj-records-q3-sales-at-rs-53-62-crore.html https://biospectrumindia.com/news/95/2237/praj-records-q3-sales-at-rs-53-62-crore.html Wed, 15 Mar 2006 10:37:00 +0530 Praj records Q3 sales at Rs Praj records Q3 sales at Rs. 53.62 crore Praj Industries, a knowledge-based company with expertise and experience in bioprocesses and engineering, recorded sales of Rs 53.62 crore and PBT of Rs 5.06 crore, and PAT of Rs 3.7 crore in the third quarter of FY 2005-06. For the nine months completed, sales are at Rs 171.96 crore (Rs 163.5 crore) and PBT of Rs 18.54 crore (Rs 21.07 crore). "There is a lag of one to one and half month in performance cycle due to various reasons including the entry point and staggered schedules of the orders/projects. The anticipated business has come through resulting in a spurt of bookings in the last three to four months. We expect these orders to result into enhanced/improved performance in the coming quarters. Additionally, we are augmenting our resources to address this increase that has also meant higher personnel costs and higher deployment of capital, impacting the bottomline to the tune of almost Rs 4 crore. Our expansion of R&D and manufacturing facility is on target," said Pramod Chaudhari, chairman, Praj Industries. LabVantage reports double-digit growth in 2005 LabVantage Solutions, Inc. an innovative global provider of enterprise solutions has achieved double-digit revenue growth in 2005, surpassing its last year's revenue. The revenues grew in each of the three global regions of operations: North America, Europe and Asia-Pacific, fueled by demand for LabVantage's Sapphire Laboratory Information Management Solution (LIMS), the company's industry-leading thin-client solution for research, development, formulation, raw material testing, and quality management laboratories across multiple industries. "We have continued to experience strong growth in R&D and quality management LIMS, and our introduction of the Sapphire BioBanking Solution further contributed to our expanded revenues. Our continued focus on providing a strong architectural foundation suppresident and CEO of LabVantage. The release noted that some of the successful organizations of the world have selected LabVantage in 2005, including Pfizer, BASF (China), Danone and Finish Red Cross. IMMCO launches operations in India IMMCO Diagnostics Inc., a US-based global company in the field of autoimmune diagnostics having its presence in more than 70 countries, recently launched its operations in India. The company has a broad range of high quality autoimmune testing reagents in Elisa, immunofluorescence and western blot formats. IMMCO is fully integrated company with its sophisticated manufacturing facility in addition to complete in-house R&D. It also serves as a reference lab in the field of autoimmune testing in the US. The Indian operation of the company is headed by MK Singh as general manager-Asia Pacific. According to him, the Indian operations will cater to the needs of entire Asia Pacific region. Prior to his current appointment, MK Singh was with Bio-Rad Laboratories. IMMCO has appointed Delhi-based Spectral Diagnostics as the sole distributor for selling its products. BD completes acquisition of GeneOhm Sciences BD (Becton, Dickinson and Company) announced the completion of its acquisition of GeneOhm Sciences, Inc., a pioneer in the development of molecular diagnostic testing for the rapid detection of bacterial organisms, including those known to cause healthcare-associated infections (HAIs), a growing global healthcare problem. The acquisition was finalized in accordance with terms originally disclosed in an announcement issued by BD on January 10, 2006. This acquisition further demonstrates BD's commitment to bringing new technologies and innovation to difficult problems in healthcare. The acquisition of GeneOhm Sciences will enable BD to move quickly into the emerging HAI field and positions the company to become a leader in the prevention of this global healthcare problem. BD will implement a broad, global initiative to work with hospitals, governments and other related parties to address the challenge of reducing HAIs. The GeneOhm Sciences array of rapid molecular assays for detection of these "super bugs" will offer important tools to address the diagnostic challenge of providing almost immediate detection of these harmful, infection-causing organisms. Manipal AcuNova standardizes on Thermo's product Thermo Electron Corporation, a global player in analytical instruments, announced that Manipal AcuNova, a Bangalore-based India's emerging CRO has standardized on its FinniganTM TSQ Quantum UltraTM triple quadrupole mass spectrometers. Manipal AcuNova employed the instruments for routine operation in its high-sensitivity, high-throughput Drug Metabolism and Pharmacokinetics (DMPK) laboratory. The Finnigan TSQ Quantum Ultra mass spectrometers were chosen because of the instruments' enhanced LC-MS/MS assay sensitivity, providing significant advantages for Manipal AcuNova during its demanding DMPK applications. "By standardizing on Thermo's instrument, we are able to take advantage of its tried and tested features to leverage our position as one of the most promising CROs in the market," said DA Prasanna, vice chairman and managing director, Manipal AcuNova. Providing enhanced ion transmission and increased sensitivity, Thermo's Finnigan TSQ Quantum Ultra series triple quadrupoles are the commercial triple quadrupoles available today capable of performing Highly Selective Reaction Monitoring (H-SRM), according to an official release. It also noted that H-SRM significantly increases quantitative specificity by eliminating matrix interferences. Ensuring rapid and accurate sample analysis, the Finnigan TSQ Quantum Ultra is designed for high productivity environments such as environmental, clinical and drug discovery laboratories. Waters's Alliance System tops in readership survey Readers of Laboratory Focus magazine selected the Waters Alliance HPLC System as the most reliable HPLC system in a readership survey conducted by the publishers of Laboratory Focus magazine. The company's release noted that the readers of the magazine have ranked Waters #1 for technical support. Introduced in 1996, the Alliance HPLC System has become a mainstay in research and development, and quality control laboratories worldwide with tens of thousands of installations across the globe, and is now arguably the most popular HPLC system in its class. ]]> <![CDATA[TAKE Solutions to launch 'track and trace' supply chain management tool]]> https://biospectrumindia.com/news/95/2600/take-solutions-to-launch-track-and-trace-supply-chain-management-tool.html https://biospectrumindia.com/news/95/2600/take-solutions-to-launch-track-and-trace-supply-chain-management-tool.html Wed, 15 Mar 2006 10:36:00 +0530 TAKE Solutions to launch TAKE Solutions to launch 'track and trace' supply chain management tool TAKE Solutions Pte Ltd, a technology enabled business solutions company with leadership in supply chain management and life sciences, will soon be launching 'track and trace', a supply chain management tool. Speaking to BioSpectrum, S Sridharan, managing director, Take Solution Pte Ltd said, "The companies in life sciences and pharmaceuticals have to adopt Radio Frequency Identification (RFID), an automatic identification method to cut the distribution cost. Even the FDA guidelines say its mandatory for them to adopt RFID by 2008. A few Indian companies have already adopted this. We see a good market potential for this in the near future." TAKE Solutions recently launched Submit SPL software that helps life sciences companies to easily manage XML data conversion to be compliant with the Structured Product Labeling (SPL) standard of the US FDA. Sharing his views on Submit SPL, Sridharan said, "About 300 labels were submitted to the FDA for approval in the last three months. These labels were produced using our product." TAKE has over ten products addressing the SCM and manufacturing space. TAKE Solutions that has operations in the USA, Sri Lanka, Malaysia and Bahrain with an employee strength of 370, posted revenue of Rs 44.07 crore for the year ended March 31, 2005 as against Rs 14.91 crore for the previous year. Sartorius secures key technology for disposable bioreactors Sartorius AG and the US-based Fluorometrix Corp, a spin-off of the University of Maryland, have concluded a licensing contract that gives Sartorius exclusive use of Fluorometrix patents in the field of disposable sensors for bioreactors. The addition of disposable sensors for detection of multiple parameters completes the Sartorius portfolio of technology for the development and construction of disposable bioreactors. Sartorius has plans for implementing these sensors as platform technology in other new products as well. "We have secured a strategic advantage for Sartorius in the rapidly growing market for disposables. The current technological challenge for the creation of disposable bioreactors lies in the use of disposable products for all components of the system â€“ including measurement and control units. The new disposable sensors complete the chain and ensure that in this year we will be one of the first companies to introduce a completely disposable reactor," said Reinhard Vogt, senior vice president of sales and marketing for the Sartorius biotechnology division. The bioreactor is at the core of every biotechnological production process: this is where microorganisms are bred under controlled conditions and either their cells or the products of their metabolic processes are harvested for use in the manufacture of pharmaceutical agents. Up to now, virtually all reactors on the market were reusable systems. Sartorius has been working on the development of bioreactors as disposable systems to meet the stringent requirements of the pharmaceutical industry regarding safety and hygiene. Waters enhances BA software for quantitative and qualitative research Waters Corporation has announced a new version of its ProteinLynx Global SERVER software, including enhancements to Waters Protein Expression System. Waters ProteinLynx Global SERVER (PLGS) 2.2.5 software features new tools allowing researchers to identify and quantify proteins and biomarkers more efficiently. Waters Protein Expression System, featuring PLGS, was the first commercial product for cost-effective and practical quantitative proteomics without the use of isotope labeling technologies. PLGS 2.2.5 extends this breakthrough technology with improved algorithms for efficient protein quantification and identification across large patient/sample sets or time-course studies. A new quantification module in PLGS allows quantitative data to be generated at the protein or peptide level using any of the commercially available or user-defined labeling technologies such as SILAC, AQUA, ICAT or iTRAQ. The ability to perform both 'label free' and 'isotopic labeling' approaches now means that PLGS provides unparalleled flexibility to analyze proteomics samples of varying type and complexity. PLGS 2.2.5 provides a 'step change' in the ability to identify proteins efficiently in complex samples by incorporating a new algorithm, which enables identification of proteins from MS E data (E - elevated collision energy) acquired from a Q-Tof type mass spectrometer. In an LC/MS experiment, a proprietary and patented 'parallel' peptide fragmentation protocol is employed to provide a 100 percent duty cycle on all detectable peptides in a protein digest. This new approach results in significantly higher sequence coverage and confidence in protein identification than traditional 'Data Dependent Acquisition' (DDA) MS/MS methods. Agilent Technologies introduces new mass spectrometer product line Agilent Technologies has introduced an entire portfolio of chromatography-based mass spectrometry (LC/MS) systems that is expected to nearly double its LC/MS market share by 2008. The new Agilent 6000 Series LC/MS portfolio is expected to set a new standard in price-performance, reliability and ease-of-use that will transform productivity in the laboratory. The Agilent 6000 Series will include five classes of instruments, including the company's first triple quadrupole (triple quad) and quadrupole time-of-flight (Q-TOF) mass spectrometers. With these additional instruments, Agilent now will be able to address nearly 70 percent of the estimated $1.3 billion LC/MS instrument market - more than double its current market opportunity. The 6000 Series also includes improved versions of Agilent's single quadrupole, ion trap and time-of-flight (TOF) mass spectrometers. "We are applying the same strategy to succeed in the LC/MS market that we used to become a leader in gas-chromatography/mass spectrometry," said Chris van Ingen, president of Agilent's life science and chemical analysis business. "We are introducing products that match or exceed the highest performance in the industry, while also providing a level of reliability and ease-of-use that will make customers' work easier, increase their productivity and expand the breadth of applications for which they can use each product." Each of the new LC/MS instruments includes the following three features that are unique to Agilent: its proprietary autotune technology which automatically calibrates the instrument with the click of the mouse, optimizing for sensitivity and mass accuracy; compatibility with Agilent's multimode source and HPLC-Chip technology; and Integrated LC and MS software for instrument control and data analysis. Pall, Biotrace ink global marketing pact Pall Corporation has entered into an agreement with Biotrace International Plc giving Pall exclusive global marketing and distribution rights to the range of Ascotec environmental air monitoring products for the pharmaceutical industry. As part of the worldwide agreement, the two companies will also work together on the development of additional innovative products for the rapid detection of contamination. Microbiological monitoring of manufacturing processes is critical to ensuring compliance with regulatory requirements and product safety. The Ascotec products are used to monitor the quality of the air and compressed gases in the production environment. They are used wherever clean rooms are required for manufacturing of pharmaceuticals, personal healthcare products and cosmetics and in other clinical environments such as hospitals to reliably capture bacteria in the environment for subsequent monitoring. The agreement will provide industry the ability to access the Ascotec air monitoring technologies to better enable them to achieve the goals of the US FDA Process Analytical Technology (PAT) initiative. The PAT initiative encourages manufacturers to adopt new analytical technologies to better control manufacturing processes and provide greater assurances of product safety. "The addition of the Ascotec air sampler to our rapid microbiology platform, including the Pallchek monitor, gives customers around the globe access to a proven technology that meets the most stringent clean room standards. It is an ideal complement to our capabilities in process and environmental monitoring technology and aligns with our business strategy to be a total solutions provider for the biotech and pharmaceutical industry," said Ken Frank, president, Pall Biopharmaceuticals. Ian Johnson, CEO of Biotrace, said, "The combination of Pall's filtration technologies and know-how with our technologies and expertise in rapid microbiology will create the next generation of fast testing solutions reducing the 'time to result' and improving production efficiency." Aseptic Technologies, Sartorius sign distribution agreement Aseptic Technologies SA, an affiliate of GSK Biologicals based in Les Isnes, Belgium, and Sartorius AG based in Goettingen, Germany, announced the formal launch of a business partnership and exclusive global distribution agreement for a novel aseptic liquid transfer system developed by Aseptic Technologies. The system comprising an optimized transfer port and disposable presterilized connection device facilitates risk-free transfer of sterile liquid to and from a contained area, with a minimal amount of ergonomic manipulation. The connection system has been successfully developed and validated to allow transfer of sterile liquid through any type of walls that separate two areas with different levels of containment. The various applications include transfer from an external area to a cleanroom, transfer from within a cleanroom to isolators used as barriers or transfer inside incubators. The principle is based on the La CalhÃ¨ne concept of the transfer port and uses a gamma-sterilized connection device consisting of a plastic hose barb connector inside a removable protective sheath. The opening of the port inside the contained area releases only the sterile part of the device, allowing easy and safe connection of tubing and transfer of liquid. The device can be installed on various container types such as gamma-sterilized containers (eg, collapsible bags) or steam-sterilized con tainers (eg, stainless steel and glass vessels). Under the terms of this agreement, Sartorius will hold the exclusive rights to market and distribute Aseptic Technologies' sterile liquid transfer system on a global basis. The companies will also commit resources to jointly develop the products to meet ongoing market expectations. ]]> <![CDATA["Cleaning validation has a long-term benefit"]]> https://biospectrumindia.com/news/95/6026/cleaning-validation-has-a-long-term-benefit.html https://biospectrumindia.com/news/95/6026/cleaning-validation-has-a-long-term-benefit.html Wed, 15 Mar 2006 10:33:00 +0530 New Page 1 "Cleaning validation has a long-term benefit" Destin LeBlanc, expert in pharmaceutical and medical device cleaning validation Destin LeBlanc regularly trains FDA investigators on cleaning validation issues. He has spent more than 25 years in the field of pharmaceutical cleaning validation, and has written and lectured internationally on cleaning validation, both as part of technical symposia as well as on-site company training. He holds nine patents and has authored numerous articles including a book on cleaning validation. During his first visit to India recently to share his experiences with key personnel of the pharmaceutical industry on "Cleaning Validation", he spoke to BioSpectrum. Excerpts of the interview: You have interacted with the pharmaceutical industry in India. Where do you think these companies stand in the area of cleaning validation? This is my first visit to India. Having said that, the Indian players are in touch with me over e-mail. They are exposed to the global scenario. They have the same kind of questions and concerns that were usually being asked by the players where I teach in Europe and the US. It seems the same level of interest exists among the players of India and players from the west. What do you feel the Indian companies should focus on? Some changes have occurred in India in the recent past. They are on patent laws and changes in the regulatory system. With these, India is now more a part of the international community. And it is going to be a level playing field in one sense. Considering this, there should be more interaction, inter change, cooperation with the group. This is going to be a positive for the Indian pharmaceutical industry. Now there are going to be more relationships with the multinationals and large pharmaceuticals in terms of being suppliers of APIs and products. India has an edge as a low cost producer over Europe and the US. But still quality is a concern. The best way to do this is to organize training sessions on issues related to cleaning validation. The focus should be on the most important, relevant things on priority basis, which add significant values and really improve the quality of the product. Attention should be given on proper utilization of the limited resources. What is the relevance of cleaning validation in the process of receiving US FDA approval? In terms of getting US FDA approval, the way cleaning validation works for the drug products is that if you have an NDA (new drug application), you can get the approval without having the cleaning validation completed. But you can't sell it or introduce it in the market until the cleaning validation is completed. So it is critical for a company to get into the market and take it to the patient. It helps the company in terms of making profits and also the patient in terms of receiving a quality product. Besides cleaning validation, there are a lot of other processes like manufacturing process, bioequivalence studies which are essential for getting the US FDA approval. What inputs are the Indian companies looking at on cleaning validation? I think they are aware of all the issues in cleaning validation. We have to do sampling and other things while doing cleaning validation. But one of the things is a sort of balancing those and trying to set all the things together. You can't spend a lot of time on doing this and ignore the rest. You have to balance the efforts of both by sitting together for the overall progress. You can't select an analytical message without considering how to do the sampling. This ultimately has to be done in a consensus manner. What are the benefits a company can reap by adopting cleaning validation? I must say that cleaning validation can reduce the cost. By doing cleaning validation properly and deciding it properly and talking about it in advance, you can do it more efficiently. So you can do it and do justice to your job. By that you are not wasting resources and can spend time properly without compromising on quality. Cleaning validation shouldn't be part of something that is necessary to save money. Hopefully it is going to save money in long term because it is going to prevent problems, recalls, contamination issues and lose. But it is difficult to quantify in terms of resources and financial terms. However, definitely it will have a long-term benefit for the companies. Narayan Kulkarni ]]> <![CDATA[Indian scientists identify new pathway to combat TB]]> https://biospectrumindia.com/news/95/2262/indian-scientists-identify-new-pathway-to-combat-tb.html https://biospectrumindia.com/news/95/2262/indian-scientists-identify-new-pathway-to-combat-tb.html Wed, 15 Mar 2006 10:31:00 +0530 Indian scientists identify new pathway to combat TB Indian scientists identify new pathway to combat TB A team of Indian scientists led by Rajesh S Gokhale, an HHMI (Howard Hughes Medical Institute) international research scholar at the National Institute of Immunology in New Delhi, has identified five key genes that enable Mycobacterium tuberculosis to acquire the iron it needs to sustain growth and promote infection. "Targeting genes within this cluster represents a good strategy for preventing tuberculosis and other mycobacterial infections," said Gokhale, the lead investigator on the study. "Because some of these genes are conserved across a number of related bacterial families, they are promising targets for drugs to treat TB and other bacterial diseases." The tuberculosis bacterium, which infects more than one third of the world's inhabitants, is a leading cause of death and disease worldwide. Gokhale and his colleagues have reported their findings in early online publication January 30, 2006, in the Proceedings of the National Academy of Sciences. When M tuberculosis infects humans, it takes up residence in immune cells called macrophages. To survive in this harsh environment, mycobacteria, like many other types of bacteria, need iron to carry out life-sustaining functions, such as creating proteins and synthesizing nucleotides to form DNA. However, free iron is not easily found in an intracellular environment. To obtain this rare element, most bacteria manufacture and secrete chemical compounds called siderophores that scavenge iron from the environment. Researchers discovered siderophores-chemical compounds used by bacteria to scavenge iron from their cellular environment-well over 50 years ago, but the genes involved in adding the long-chain lipid anchor that enables M. tuberculosis to do so more efficiently, remained a mystery until now. Mycobacteria have evolved siderophores with lipid-chain tails that enable them to exploit the macrophage's lipid-trafficking system to capture iron more efficiently. Instead of using siderophores that diffuse freely, mycobacteria anchor their siderophores to lipid membranes by means of a long fatty acid tail. After these siderophores bind to iron within the macrophage, the lipid tail makes the iron "sticky" enough to permit delivery to the very compartment in macrophages where the mycobacteria are lurking. Using microarray data, the available literature, and intuition, Gokhale's group identified the location of the four genes that produce the lipid tail after observing that the expression of the genes significantly increased in response to low iron concentrations. The gene required for the synthesis of the siderophore core, called mbt-1, functions the same way, so Gokhale's team named the new locus mbt-2 and the new genes mbtK, mbtL, mbtM, and mbtN. His team has already determined that some of genes from the mbt-2 cluster are conserved across several other bacterial species that cause various pulmonary, skin, and organ diseases. Since the mbt-1 genes are also conserved across many bacterial families, the mbt genes appear to be ideal antibacterial targets for treating tuberculosis and other bacterial infections, he said. Biodegradable implant to increase success rate for glaucoma surgery A Taiwan-based company has developed a collagen matrix which significantly increased the success rate for glaucoma and other selective ophthalmic surgeries. The product has been approved by four university hospitals in both Taiwan and China. The first IRB approval was done last June. The clinical trial has been conducted in these hospitals and the results have been very encouraging. This collagen matrix was developed by the Taiwan based Pro Top & Mediking company. Last year in December OculusGen Biomedical Inc. acquired Pro Top & Mediking completely and the product was christened as OculusGen Collagen Matrix Implant. OculusGen is probably the only product of its type worldwide and its research team consists of several eminent ophthalmologists and biologists. It is primarily designed to increase the success rate of glaucoma filtration surgery. The collagen matix is implanted on the top of the sclera flap under conjunctiva before the suturing. It is biodegraded within 90 days and it normalizes the bleb function by offering both physical and physiological effects. Good results were observed in the animal and preliminary clinical trial without any anti-metabolite. In addition, OculusGen can be used in other selected ophthalmic surgeries, such as pterygium excision, eye plastic surgery, strabismus correction surgery, conjunctiva scar removal surgery, and nasolacrimal duct surgery, etc to prevent scar formation and speed up wound healing. The product follows a strict quality management system and is a biocompatible collagen implant. The company is now processing an application for the CE Mark and expects to attain the mark in April 2006. The US FDA IDE submission will be made in a month or two. Scientists develop avian flu vaccine University of Pittsburgh researchers have announced that they have genetically engineered an avian flu vaccine from the critical components of the deadly H5N1 virus that completely protected mice and chickens from infection. Avian flu has devastated bird populations in Southeast Asia and Europe and so far has killed more than 80 people. Because this vaccine contains a live virus, it may be more immune-activating than avian flu vaccines prepared by traditional methods, said the researchers. Furthermore, because it is grown in cells, it can be produced much more quickly than traditional vaccines, making it an extremely attractive candidate for preventing the spread of the virus in domestic livestock populations and potentially in humans, according to the study, published in the February 15 issue of the Journal of Virology and made available early online. "The results of this animal trial are very promising, not only because our vaccine completely protected animals that otherwise would have died, but also because we found that one form of the vaccine stimulates several lines of immunity against H5N1," said Andrea Gambotto, assistant professor in the departments of surgery and molecular genetics and biochemistry, University of Pittsburgh School of Medicine, and lead author of the study. Dr Gambotto and his colleagues constructed the vaccine by genetically engineering a common cold virus, called adenovirus, to express either all or parts of an avian influenza protein called hemagglutinin (HA) on its surface. Found on the surface of all influenza viruses, HA allows the virus to attach to the cell that is being infected and is, therefore, critical to the influenza virus' ability to cause illness and death. Since the late 1990s, a number of outbreaks of the avian influenza H5N1 in poultry have occurred in Cambodia, China, Indonesia, Japan, Laos, South Korea, Thailand and Vietnam. Outbreaks recently have been reported in Turkey and Romania. To date, H5N1 has caused the most large-scale and widespread bird deaths in known history - an estimated 150 to 200 million birds have either died in the outbreaks or been killed as part of infection control actions in the last eight years. Based on the published sequence of the Vietnam strain of the H5N1 avian influenza virus, members of the University of Pittsburgh Vector Core Facility, led by Wentao Gao, PhD, research instructor in the School of Medicine's department of surgery, constructed several adenovirus "vectors" - viruses that have been modified to serve as a vector, or delivery vehicle, for foreign genes or DNA - containing either the full genetic sequence of the HA protein or sequences for only parts, or subunits, of HA. They also constructed a vector containing sequences for a portion of the HA protein from the H5N1 Hong Kong strain. Collaborating with investigators of the Influenza Branch of the Centers for Disease Control and Prevention, Dr Gambotto's team tested the ability of their slightly different vaccines to protect mice from infection by wild-type H5N1 by comparing its performance to an adenovirus vector containing no H5N1 genes, or an "empty vector." The investigators then observed the H5NI-exposed mice for any signs of illness, including weight loss and death, and also checked their blood for anti-viral antibodies and other markers of H5N1-specific immunity. All of the mice immunized with the empty vector vaccine experienced substantial weight loss beginning about three days after exposure to wild-type H5N1, and all were dead within six to nine days of avian flu exposure. In sharp contrast, most of the mice immunized with the adenovirus containing either the whole or part of the HA protein showed only mild and short-lived weight loss and survived H5N1 infection. Dr Gambotto and his colleagues suggest that rather than replacing traditional inactivated influenza vaccines, their adenovirus-based vaccine could be a critically important complement to them. Because it appears to be so successful in immunizing chickens against H5N1, widespread inoculation of susceptible poultry populations could provide a significant barrier to the spread of the virus via that route in this country and other countries that have so far been spared from avian flu. Also, if there were a disruption in the traditional vaccine production pipeline, a recombinant vaccine could be an attractive alternative for human immunization as well, they said. The recombinant vaccine approach grows the vaccine in cell cultures, which are unlimited in supply. Another major advantage of this approach is its speed. "It takes a little over a month for us to develop a recombinant vector vaccine compared to a minimum of several months via traditional methods," he explained. "This capacity will be particularly invaluable if the virus begins to mutate rapidly, a phenomenon that often limits the ability of traditional vaccines to contain outbreaks of mutant strains." Dr Gambotto added that his group is planning a small clinical trial of the vaccine in humans in the very near future. Adult stem cell trial may bring hope to heart patients A world-first human clinical trial being conducted at John Hunter Hospital, Australia may bring new hope to patients with severe coronary artery disease. Medical investigators have safely implanted adult stem cells into the heart of two patients via cardiac catheter under local anaesthesia as part of a trial which aims to evaluate the safety and standard operating procedures of Mesoblast's adult stem cell technology. Mesoblast Limited is an Australian biotechnology company committed to the development of novel treatments for orthopaedic conditions, including the commercialization of a unique adult stem cell technology aimed at the regeneration and repair of bone and cartilage. Interventional Cardiologist and Hunter Medical Research Institute (HMRI) researcher, Dr Suku Thambar, who is chief investigator for the trial, said that both procedures went well and the patients have been discharged from hospital. HMRI is one of Australia's most innovative health and medical research institutes. "We hope that Mesoblast's specialist stem cell technology will provide greater hope and better outcomes for patients with severe coronary artery disease who otherwise have very few options for significant improvement or quality of life," said Dr Thambar. "Each patient's stem cells were extracted from bone marrow in December 2005 and then grown in a laboratory using Mesoblast's proprietary technology, which can cultivate millions of cells from a single donor within a six to eight week period. In each procedure about 100 million of the patient's own stem cells were injected into damaged areas of the heart muscle, which we hope will begin to repair damaged tissue. "Improvement will be assessed in terms of patient symptoms and objective evidence of improved blood supply to the target areas," Dr Thambar added. Mesoblast chief scientific advisor, Prof. Silviu Itescu, said that Mesoblast aims to develop a safe and effective treatment for a broad range of degenerative diseases. "Millions of people worldwide are affected by congestive heart failure and coronary artery disease. There are very few options available to treat these conditions. Current methods of treatment including pharmaceuticals, surgery, cardiac replacement and mechanical assistance do not result in cardiac regeneration and are generally extremely expensive and highly invasive," Prof. Itescu said. The trial has been approved by the Hunter Area Research Ethics Committee. Dow AgroSciences achieves world's first registration for plant-made vaccine U S-based Dow AgroSciences LLC, a wholly owned subsidiary of The Dow Chemical Company, has received the world's first regulatory approval for a plant-made vaccine from the United States Department of Agriculture (USDA) Center for Veterinary Biologics. This approval represents an innovative milestone for the company and the industry. "With this achievement, Dow AgroSciences is revolutionizing the field of preventative medicine with plant-cell-produced vaccines," said Butch Mercer, Dow AgroSciences' global business leader for Animal Health. The Dow AgroSciences Concert Plant-Cell-Produced System represents a new category of plant-made vaccines. This leading edge technology utilizes plant cells instead of whole plants in a secure, bio-contained environment to produce vaccines. Because of this bio-contained production system, concerns and challenges associated with making vaccines in whole plants or food crops are eliminated. The Concert Plant-Cell-Produced System uses only the necessary parts of the disease causing agent to stimulate immunity in a manufacturing process that is totally free of animal components. According to John Cuffe, Dow AgroSciences' R&D leader for Animal Health, "This approval is a perfect example of how biotechnology is advancing science by creating a new category of vaccines that is both safe and effective." By achieving this regulatory milestone, the company has demonstrated that this new technology fits within the existing USDA Center for Veterinary Biologics regulatory approval process. It can now focus its efforts on developing new, innovative vaccines with an emphasis on animal health. Possible target animals include: horses, companion animals (such as dogs and cats), poultry, swine, and cattle. Furthermore, utilizing this revolutionary technology for human diseases is a real possibility. This milestone achievement by Dow AgroSciences was the result of effective collaborations with prominent organizations and institutions including Washington University, Boyce Thompson Institute for Plant Research, Benchmark Biolabs, Inc., and The Biodesign Institute at Arizona State University. In less than five years Dow AgroSciences moved the science forward, established a production facility, and received this regulatory approval. Study unearths mutant gene behind heart drug inaction New research from China indicates that about 30 to 50 percent of East Asians might carry a genetic trait that blocks the body's ability to process the heart drug, nitroglycerin, rendering it useless. In the normal run, the human body converts nitroglycerin to nitric oxide, which relaxes and expands the smooth muscles of blood vessels. This improves blood flow and means the heart has to pump less forcefully to keep blood circulating. Nitroglycerin has since been used in pill form and in a pump spray to provide quick relief, and as a patch worn for continuous improvement to blood flow. However, the exact mechanism of action of nitroglycerin was not known till the year 2002. It was only then that the researchers discovered that the enzyme ALDH-2 helps the body convert nitroglycerin into its helpful form of nitric oxide. Significantly the gene which produces this enzyme, has an unusual expression in Asians, especially the East Asians. In fact, earlier studies have estimated that 30 to 50 percent of Asians have a mutated and inactive form of this gene where as other populations have a very low frequency of this phenomenon. Dr Li Jin, a population geneticist and lead scientist of the project along with his colleagues conducted their study with 111 Han Chinese patients who all had coronary heart disease and dosed themselves with a nitroglycerin tablet under the tongue during acute angina attacks. While 80 people in the study reported relief within 10 minutes of taking nitroglycerin, the other 31 people said they experienced no pain relief at all. Testing showed most of these "non-responders" carried the mutant gene. However, the researchers note other genes and environmental factors might also be in play since this one genetic trait could not explain the lack of response in all the patients who felt no relief. Nevertheless these observations are so striking that scientists at Fudan University in Shanghai suggest doctors reconsider prescribing nitroglycerin to East Asians. This report will appear soon in the Journal of Clinical Investigation. The linkage of the drug "inaction" to the mutant gene comes under the field of pharmacogenomics, where the drugs could be tailored to a person's gene type to maximize benefits and minimize side effects. Presently the tests to detect the genetic trait are not widely available and thus personalized medication is still far off. Since designing drugs for the individual remains a distant goal, research into the genetic traits common in particular groups and ethnic populations has become a proxy in the interim. Critics warn, however, that it could be dangerous to apply these findings in the clinic since nearly all mutations can be found in people of various ethnic backgrounds, albeit at lower frequencies. However, enthused by these results, the Fudan researchers now have a much larger investigation under way. As scientists have rightly pointed out that the present study sample was a small one for a genetics study. New protein discovery could improve ability to fight viruses Scientists have discovered how a single protein could dramatically improve the body's ability to fight viruses such as the flu. A study, published in the January edition of Nature Immunology, identified a protein found naturally in the body may be the secret weapon scientists have been looking for in the fight against infectious diseases such as the flu and hepatitis. Australia-based Monash Institute of Medical Research (MIMR) led the collaborative study that discovered how the protein, SOCS1, is involved in the body's defence system, and could be manipulated to become a powerful antiviral drug. "SOCS1 acts like a switch that tells the body when to inhibit interferon; a protein produced as part of the body's normal immune response," said MIMR Post-Doctoral scientist and lead author, Dr Jennifer Fenner. "Our discovery means we can now manipulate the relationship between SOCS1 and interferon, and eventually target specific diseases," she said. "This could improve resistance to infections, reduce complications of inflammatory diseases and improve vaccinations." Prof. Paul Hertzog, director of MIMR's Centre for functional Genomics and Disease, said the discovery could have implications for a wide range of diseases for which there are no cures. "Although it will be about 10 years before any drugs are available, we're already working with biotechnology company Zenyth (formally Amrad) to develop potential therapies, including vaccines, based on our research," he said. "As SOCS1 is produced by most cells in the body it has the potential to become a generic treatment for a range of infectious and inflammatory diseases and possibly even cancer."   ]]> <![CDATA[Serum Institute to invest Rs 1,200 crore in India]]> https://biospectrumindia.com/news/95/4655/serum-institute-to-invest-rs-1200-crore-in-india.html https://biospectrumindia.com/news/95/4655/serum-institute-to-invest-rs-1200-crore-in-india.html Wed, 15 Mar 2006 10:27:00 +0530 Serum Institute to invest Rs 1 Serum Institute to invest Rs 1,200 crore in India's first biotech SEZ in Pune Dr Cyrus S Poonawalla, chairman, Serum Institute of India Ltd, along with his wife Villoo Poonawalla inaugurating the Serum Bio Pharma Park. Adar Poonawalla, executive director â€“ operations, Serum Institute of India (extreme left) and Zavaray Poonawalla look on. Dr Cyrus S Poonawalla, chairman and managing director, Serum Institute of India Ltd, inaugurated Serum Bio Pharma Park, the country's first biotech Special Economic Zone (SEZ) at Pune on February 23, 2006. The SEZ, located at Hadapsar, adjoining Serum Institute's existing manufacturing unit, is a sector-specific SEZ meant for biotechnology and pharmaceutical products. With the inauguration of the Serum Bio Pharma Park, the Serum Institute of India Ltd, India's largest exporter of vaccines and immuno-biologicals and a flagship of the Poonawalla Group of Companies, has entered the real estate business too. Speaking to mediapersons, Dr Cyrus S Poonawalla said, "Though our focus is on manufacturing vaccines for masses at an affordable price, we are forced to enter this new area. It will facilitate the growth of the niche biotechnology industry. Indian biotechnology today is making rapid strides in research and development. With the inauguration of the first biotech SEZ, development of the biotech industry in India will get the much needed encouragement and support." The SEZ, which has currently been allocated 55 acres of notified land in the first phase, would, based on availabilities and opportunities, be gradually expanded to 250 acres. The SEZ will stimulate economic activities by offering larger employment opportunities, attract substantial investments for export production and render services abroad to earn more foreign exchange. Elaborating on the investments, he said, "The investments in the project will be divided in phases. The Phase I investment will be a minimum of Rs 500 crore. The total investment will build to at least Rs 1,200 crore. We are quite sufficient to raise funds through internal accruals of the company." Giving details about the park, Adar Poonawalla, executive director â€“ operations, Serum Institute of India Ltd said, "Serum Institute will have 5-6 units in the SEZ. Development work on the SEZ has already commenced. A few units would also be commencing production in the next 3-5 months. The project is expected to be completed by 2010." "About one billion doses of various vaccines are expected to be produced on an annual basis from this SEZ. The new zone would manufacture vaccines for pneumonia, rotavirus, and combination vaccines for the entire range of meningitis, influenza and Hib. Oncological products for the US and EU markets are also expected to be manufactured at the new facility. The premises has already been pre-qualified by the World Health Organization," added Dr Cyrus Poonawalla. Serum Institute of India recorded revenues of Rs 600 crore in 2004-05 and is targeting a turnover of Rs 750 crore this fiscal. Ernst & Young unveils Health Quotient India has traditionally been a volume player, accounting for approximately a third of global sales, but a 10 percent share in value terms. "In order to achieve global leadership, Indian companies need to move towards a more value driven model comprising a mixed portfolio of products, targeting both developed and developing countries. This needs to be supplemented with aggressive marketing and cost effective R&D and manufacturing," said Utkarsh Palnitkar, health sciences industry leader, Ernst& Young India. He was speaking at the release of Health Quotient, an Ernst& Young report on the issues and opportunities in the Indian pharmaceuticals, biotech and healthcare sectors, at BioAsia 2006 in Hyderabad on February 10, 2006. The report says there is significant opportunity for developing products targeting diseases like malaria, rotavirus, tuberculosis and Japanese encephalitis. The availability of highly skilled research scientists and low cost of operations makes India an ideal location for developing vaccines for these diseases. Besides in the recent times the Indian companies are being able to minimize the fixed manufacturing costs. The report says the changing market dynamics supported by recent government initiatives and setting up of the US FDA approval office in India are expected to further cut the costs. The report also adds that unlike most of the biopharmaceutical markets, vaccines possess certain district facets, which enhance India's competitiveness. These include the presence of large institutional buyers, the generics-driven nature of the market and relatively lesser interest from large multinational players. Dr Reddy's Lab buys Germany's betapharm for $570 million Continuing the trend of consolidation in the global generics business, India's pharma major, Dr Reddy's Laboratories has announced a $570 million acquisition of betapharm, Germany's fourth largest generics company. The all-cash deal, facilitated by leading German private equity house, 3i, was announced recently. Dr Reddy's outbid world's largest generics company, Teva, drug giant Sanofi-Aventis and India's largest pharma company, Ranbaxy to buy betapham. A company statement said the betapharm acquisition formalities will be completed in a month. Dr Reddy's has taken 100 percent stake in betapharm and the acquisition will be funded by internal accruals and debt. Analysts expect the betapharm acquisition to add $ 200 million to Dr Reddy's topline immediately and the company's shares jumped 9.38 percent to hit its 52-week high price on the Bombay Stock Exchange. Commenting on the acquisition, Dr Anji Reddy, chairman, Dr Reddy's Laboratories, said, "Today is truly an exciting day for Dr Reddy's. We see our investment in betapharm as a key strategic initiative towards becoming a mid-sized global pharmaceutical company with strong presence in all key pharmaceutical markets. betapharm has created a strong growth platform and is well positioned for the future and we are looking forward to partner with them in building a strategic presence in Europe." This acquisition of betapharma was on the cards for some time. Utkarsh Palnitkar, director, Ernst & Young, had predicted a $500 million deal in the global generics sector in his special report, Health Quotient, which was released at the BioAsia 2006 conference in Hyderabad. Dr Wolfgang Niedermaier, CEO of betapharm said, "Dr Reddy's impressive pipeline of generic and innovative products and its high quality standards combined with competitive manufacturing infrastructure will help further develop our position in the German market and offer an entry platform for the European market. It's extensive and well recognized corporate social responsibility activities perfectly fit with our successful corporate philosophy and business model. We see Dr Reddy's as our partner of choice to build a successful joint future and continue betapharm's growth and success story." Kemwell acquires Pfizer manufacturing facility in Sweden Kemwell Pvt Ltd, a Bangalore-based formulations contract manufacturer, has acquired Pfizer's manufacturing plant in Uppsala, Sweden, for an undisclosed sum. The production unit manufactures both API and finished drug. Kemwell is the first Indian contract manufacturer to acquire business abroad. The facility is approved by USFDA, EMEA, and Japan's regulatory authority and will supply to 80 markets, including USA, Europe and Japan. Perake Oldentoft, Kemwell Board Member based in Sweden, said, "We are excited to welcome the dedicated, qualified and skilled team at Uppsala to join our global business. With their support we have judged it possible to continue and hopefully develop our operations in Uppsala." According to Subhash Bagaria, chairman and managing director of Kemwell, "Kemwell's goal is to be a leading global partner to pharmaceutical and biotechnology industries offering services ranging from formulation development to cGMP compliant commercial manufacturing. This transaction builds on Kemwell's extensive experience in contract manufacturing and demonstrates our commitment to strengthen and broaden our pharmaceutical business through strategic global acquisitions." Zeibrant Lindqvist, CEO, Pfizer Health AB, said, "By selling the production facility, we believe that the plant and jobs will remain in the region." Several companies were interested in buying the manufacturing facility at BolÃ¤nderna. Kemwell was chosen partly because it has the long-term aim of establishing itself in Europe and develop its relations with Pfizer. Kemwell has been clear about its plan to remain in BolÃ¤nderna: after the purchase, it will take over responsibility for the plant's 170 employees. The acquisition is expected to be completed by April 2006 and will lead to a significant growth in Kemwell's contract business. The facility will provide access to technology and quality standards on a continuing basis. Kemwell plans to introduce other value-added services such as formulation development and analytical method development and validation to the site. eClinical trials market to reach $357.4 million by 2011 With life sciences and pharmaceutical companies showing a definite inclination towards electronic technologies and investing substantial amounts in transitioning from paper-based to electronic processes, revenues in the eClinical trials (eCT) market are expected to increase from approximately $210 million in 2004 to $357.4 million in 2011, according to a study from Frost & Sullivan. The study noted that the adoption of eClinical technologies currently remain largely confined to pilot projects, barring a few implementations by some major pharmaceutical companies. The adoption of these technologies is dependent on the ability of the senior management in an organization to take the electronic revolution to the grassroots level. "In eCT, it is the human element of resistance to change that is the greatest challenge rather than the technology itself. This is why the majority of adoption, thus far, has been in the form of small pilot projects," observed Raghavendra Chitta, Research Analyst with Frost & Sullivan. He further said, "The resistance mainly stems from research scientists in life sciences companies since there is great reluctance among them to accept newer electronic processes. Shifting to eCT technologies would not only mean adapting to more technically sophisticated processes, but could also require a complete redistribution of roles and responsibilities." Moreover, companies need to implement eCT technologies across their organizations for them to be truly successful. Implementing these technologies in isolation in a few clinical research teams will not yield the desired results. Therefore, the major task at hand for eCT technology vendors is to convince all stakeholders in the clinical trials process to adopt and integrate these technologies across all teams within the organization. Kalam moots nanoscience and technology consortium President APJ Kalam has exhorted the industry and government to start a focused mission to capture at least five percent of $50 billion nanotechnology market share within 10 years. He suggested to launch vertical missions under an umbrella organization like CII and NASSCOM in partnership with DST, R&D institutions, universities and public-private investment in at least 10 nanotechnology products in water, energy, agriculture, healthcare, space and defense and ICT sectors. President Kalam was delivering the inaugural address at the two day Indo-US Nanotechnology Conclave organized by the Confederation of Indian Industry (CII) and Indo US science and Technology Forum. "The next ten years" the President said "will see nanotechnology playing the most dominant global business environment and is expected to go beyond the estimates and cross the figure of one trillion." He urged scientists, industrialists and venture capitalist to work together to provide cost effective quality products using nanotechnology to the global society at the right time. He mentioned that partnership of India and the US in the area of their own core-competencies could benefit the industry on both sides. Based on the model of Singapore, he advised the ministry of human resources development and DST to launch a major capacity building drive for developing the human resource on convergence of technologies in the bio, info and nano science and technologies. Kapil Sibal, minister for science and technology, in his address stated that almost every country in the world had started working on nanotechnology and welcomed the conclave as a new set up, a collaboration of the academia and the industry which would lead to the production of concrete commercial products for the country. Sibal pointed out that the Indian government had taken up this technology on priority basis and presently about 40 universities in the country were working on this. The budget for this could go up substantially from 125 crore to 500 crore in the next five years, he stated. US Pharmacopeia opens office in India US Pharmacopeia, the world's leading pharmaceuticals standards organization has ventured out of its Washington DC home for the first time in its 84-year history to set up an office and laboratories in this southern Indian city of Hyderabad. The USP's India site was formally inaugurated by its CEO Roger Williams on February 9, 2006. "This is a historic occasion and now we have a home in India too," said William. The entire top management team of USP including Darrell Abernethy, president of the USP convention, John Fowler, chief business officer, witnessed the formal inauguration by Andhra Pradesh's industry minister, Dr J Geeta Reddy, herself a well-known child specialist and gynaecologist. USP's India site is located at the ICICI Knowledge Park, part of the Genome Valley region, one of India's fastest growing bioclusters. From an initial headcount of 17, USP India is set to increase the team size manifold to make quality drugs available around the world at affordable prizes. The USP-India site has been set up in a record time of nine months and is expected to leverage the availability of chemical process and technology experts in India. " This decision of USP will help Indian pharma companies as well as the industry in the Asian region to get the standardization certificates for their products done by USP-India at more affordable rates and increase their export competitiveness in the world's regulated markets," said a leading pharma expert and former head of AstraZeneca's research center, Dr S Anand Kumar. Williams emphasized that USP-India site would help it become an integral part of the $8 billion Indian pharma industry. India's pharma sector is the 4th largest in the world in volumes and 13th largest in value. A recent study by leading consultants, McKinsey has projected India's pharma industry to grow to $ 25 billion by the year 2010. " We have chosen to come to Hyderabad due to the excellent conditions and availability of talent to carry out collaborative research work which will help raise overall standards of medical products in India and the world," said USP-India's vice-president (international), Kumud Sampath. Emphasizing the importance of the event, US Government's Consul General in southern India, David Hopper said the India office of USP will not only help India but also the US and public health overall. " India has one of the world's fastest growing generics industry and a range of high quality products which are benefiting consumers in the US and rest of the world. USP-India will help in setting high quality standards for these products and counter the growth of counterfeit drugs which endanger public health." Narayanan Suresh in Hyderabad HCL ties up with Synchron for clinical trial solutions HCL Technologies, a leading global IT solutions provider in Information Technology, has entered into a strategic alliance with Synchron Research Services, an Ahmedabad-based CRO, to jointly provide innovative solutions like clinical trial and data management on drugs and devices. This is a path breaking initiative by HCL to become an end-to-end solution provider in clinical trials and data management. With its extensive domain knowledge and pool of skilled professionals from the Life Sciences sector, HCL will provide software consulting, infrastructure management and BPO services in clinical trials and clinical data management that is run by Synchron across the globe. This symbiotic engagement would enable Synchron to access HCL's customer in the IT services related to clinical trial space and HCL will be able to utilize Synchron's reach in the US, Japan, European and Asia Pacific markets. "This is the first time Synchron has engaged in a relationship with a leading IT service provider. Our decision to work with HCL signifies that we would put our trust in the leader in this arena. The key factor in choosing HCL as our preferred partner is its revolutionary experience and execution capability in the life sciences space," said Dr Shivprakash, managing director, Synchron Research Services. Chidambaram ignores biotech industry The Union Budget presented by the finance minister, PC Chidambaram, on February 28, 2006 lacks the much needed emphasis and thrust to the biotech sector. "The Indian biotech sector is on the threshold of significant growth opportunities. The biggest being an opportunity to create India as an R&D hub for global biotech companies. The biotech industry had expected support from the Budget on the recommendations as well as fiscal measures to increase domestic and international investment. The biotech industry needed this much need support to mature and grow into leadership position vis-Ã -vis countries like China, Singapore, Korea and Eastern Europe. The industry is now hopeful that these would be met at the time of the implementation of the much-awaited Biotech Policy during the course of the new financial year," observed Nitin Deshmukh, head, Private Equity, Kotak Mahindra Bank Ltd and director, ABLE. Dr Ajit Dangi, director general, Organization of Pharmaceutical Producers of India (OPPI), observed, "The thrust of this year's Union Budget is on infrastructure, power, agriculture and education. Although there is reduction in customs duty on anti-AIDS and anti-cancer drugs to 5 percent and removal of free medicine samples given to doctors from the ambit of fringe benefit tax, the Union Budget 2006-07 has fallen short of the expectations of the pharma industry. Even there is no mention about the biotechnology in this Budget. As far as pharma sector is concerned, I will rate it at 4.5/10." According to Alok Gupta, country head, life sciences and biotechnology, Yes Bank Ltd, the Government has continued its commitment to developing the overall healthcare sector in the country - National Rural Health Mission is one of the eight flagship programs and allocation has been increased by 22 percent from Rs 6,553 crore to Rs.8,207 crore. Research and development also continues to be a focus area and the government announced schemes such as establishing technology business incubators and providing financial assistance to specific institutions such as Universities of Calcutta, Mumbai and Madras and autonomous national institute status provided to Rajiv Gandhi Centre for Biotechnology in Kerala. Financial and business support to these incubators will be crucial for development of the biotechnology industry. He further pointed out, "Customs duty reduction on 10 anti-AIDS and 14 anti-cancer drugs to 5 percent and on certain life saving drugs, kits and equipment from 15 percent to 5 percent, with these drugs being exempt from excise duty and CVD. FBT to exclude expenses on free samples of medicines and of medical equipment distributed to doctors, which is expected to be a positive for pharmaceutical and medical equipment manufacturers. Withdrawal of 10(23G) will have an impact on capacity building in the healthcare sector." However, the issues relating to increased R&D exemption, constituents of R&D costs such as patent expenses and clinical trials costs were not clarified. Mahesh Sawant, program manager, healthcare practice, Frost & Sullivan, felt that overall the Budget sounded good for the public and industry with a lot of benefits being offered. "The allocation for healthcare has been increased by 22 percent to Rs 12,546 crore and also the National Health Mission allocation increased to Rs 8,207 crore from Rs 6553 crore, which looks very promising to boost development in this sector." Utkarsh Palnitkar, director, health sciences, Ernst & Young, said, "The finance minister in his Budget speech reviewed the focus on the National Rural Health Mission by increasing the outlay to Rs 8,270 crore from Rs 6,553 crore. This is indeed a significant move taking into account that the bulk of health care trade rests on the private sector and that the most significant element in health care is the inpatient treatment where the cost of pharmaceutical drugs constitutes only around 20 percent of the total cost of recovery. However, what needs to be examined is the effective implementation of the scheme in a time-bound manner to ensure that the institutions required for the final leg of delivery are in place. The focus on health is evident by the fact that the allocation for health and family welfare has been enhanced by 22 percent to Rs 12,546 crore." He added, "The only mention in respect of biotechnology was the accordance of the status of autonomous national institute to the Rajiv Gandhi Centre for Biotechnology in Thiruvananthapuram, Kerala. The increasing focus in India, subsequent, to the amendment in the Patent Act will be on innovation and discovery. The present provisions provide for a weighted deduction of 150 percent, as well as, a tax holiday for R&D units set up on or before March 31, 2007. It is hoped that such tax holiday will be extended by at least a period of 5 years to enable India to derive the true benefits of investments in R&D. Another significant cost is the legal cost related to the approval of patents which could also have been granted a higher weighted deduction." "In the area of pharmaceuticals, non-levy of FBT on free samples of medicines and medical equipment is indeed a very welcome move and this will provide much relief to pharmaceutical formulators. Pharmaceutical companies also have a far more significant proportion of seminars and conferences which will focus on wellness. It would have been beneficial to treat such conferences which are essential for disseminating knowledge on new discoveries, as exempt from FBT. The reduction in customs duty, from 15 percent to 5 percent and exemption from excise and countervailing duty (CVD), on specified anti-aids and anti-cancer drugs is indeed very welcome. However, given the nature of these elements a complete exemption would have been warranted. In addition the reduction of duty on basic inorganic chemicals from 15 percent to 5 percent and on catalysts from 10 percent to 7.5 percent in certain cases is likely to become an encouraging factor for the raw material manufacturers which supply to pharmaceutical/biotech companies," he pointed out. He further noted, "Entrepreneurial R&D has gathered momentum courtesy the commitment of the government in terms of seed funding and setup assistance for business incubators. The finance minister also proposed to strengthen R&D by providing concessions to the incubatee-entrpreneurs. This will give a fillip to the Indian pharmaceutical and biotech companies which are increasingly looking at product innovation to evolve as global entities." ]]> <![CDATA[Bangalore gears up for Bangalore Bio 2006]]> https://biospectrumindia.com/news/95/2163/bangalore-gears-up-for-bangalore-bio-2006.html https://biospectrumindia.com/news/95/2163/bangalore-gears-up-for-bangalore-bio-2006.html Wed, 15 Mar 2006 10:25:00 +0530 Bangalore gears up for Bangalore Bio 2006 Bangalore gears up for Bangalore Bio 2006 The three-day event will have special focus on agri-biotech Over 60 national and international speakers, 400 conference delegates, 125 exhibitors, 20000 busi ness visitors from over 15 countries, various states of India, will convene at the premier annual event for the biotechnology industry at Bangalore BIO 2006. The event, now in its sixth year, will be simultaneously a conference, a business forum and a trade exhibition for the entire biotech and allied industry fraternity and will take place during June 7, 8 and 9, 2006 at the Palace grounds in Bangalore. Highlights of the announcement MK Shankaralinge Gowda, secretary, Department of IT, Biotechnology and Science & Technology, Government of Karnataka The 100 acres biotech park in Bangalore will be operational by the end of 2006 near Electronic City. This project has been awarded to the National Building Construction Company. Karnataka supports investments from biofuel companies. Citing the example of the Indian Railways, biofuel farming, where-in 90,000 hectares of land have been allocated for this purpose. Karnataka has attracted the highest VC fund in Asia (to the tune of $100 million). Karnataka will support stem cell banks and other new areas of biotechnology. Kiran Mazumdar Shaw, chairperson, Vision Group on Biotechnology and CMD, Biocon Ltd Bangalore is evolving as an interesting ecosystem for biotechnology. Other states are also taking the initiative to follow the Bangalore model of success To create a biocluster, one needs a mind set of entrepreneurship and Bangalore has paved the way in this regard To accelerate entrepreneurship, companies such as Biozeen have set up training programs for bioprocessing. The institute of clinical research has been set up and will help to enhance clinical development in the country We need to expand infrastructure, not just roads and airports but also patent infrastructure and service infrastructure International patent law firms are looking at India to set up their consulting firms The government should take the lead for special initiatives on biofuel and bioagri technology. There is a global challenge for affordable drug development, infrastructure for clinical trials, clinical researchers, and centers need to be developed.   This flagship biotech event is promoted by the Government of Karnataka and organized by the Vision Group on Biotechnology. This $1-billion industry is poised to be $5-billion by 2010 and Bangalore Bio has emerged as the undisputed unique platform for the biotech fraternity to interact, network and explore business opportunities through its trade show and international conference. Bangalore Bio 2006 focal theme is "DNA Discover, Nurture, Accelerate" and is an important networking platform where the who's who of the biotech fraternity will converge to showcase their products and services, to transform concepts into markets, explore investment and partnering opportunities and forge new alliances in the biotech industry globally. The event promises to bring together the best of a wide spectrum of biotech companies, RPOs, biosuppliers and process engineering equipment companies, R&D institutions, biotechnology educational institutions, venture capital and financial institutions. An exclusive B2B platform will be provided to explore business opportunities. At least 20 international speakers are expected to address the multi-track conference to be held at JN Tata Auditorium Bangalore. India is emerging as the R&D lab of the world. Clinical research and research processes outsourcing is becoming the core strength of India. Keeping this global trend in mind, the spotlight at this year's conference is clinical research. Other topics to be deliberated upon by over 60 international biotechnology experts are research process outsourcing, drug discovery and development, vaccines and vaccinology for the developing world, frontier technologies, bioinformatics, intellectual property rights, portfolio management, human resource development, biotechnology and global alliances. Another interesting feature at Bangalore Bio 2006 will be Agribiotech Day, a one-day track on agribiotechnology. The sessions will address various important topics like transgenic crops, regulatory issues, environmental concerns, biofuel, food biotech, nutraceuticals and so on. The CEO Conclave always witnesses a high power meeting point of various professionals and this year Dr RA Mashelkar, director general, CSIR and secretary, DSIR will deliver the 'Vision Talk' at the conclave. This year Bangalore Bio 2006 is adding one more exclusive feature - the poster session in conjunction with the international conference. The objective is to create a platform for young researchers, scientists and technocrats working in universities, R&D labs, various government departments or private sector to present their research work and projects and interact with industry top honchos and Indian and global venture capitalists. More than 120 national and international participants are expected to showcase the latest in technology, research and trade in the exhibition sprawling over an area of over 4500 sqm. The sponsors include Biocon, Avesthagen, Sami Labs Limited, UK Trade and Investment, Exim Bank, Strides, Alfa Laval, Jetro, Biosys, Sartorius, Astrazenaca, Jalaja Technologies, Acharya Institute, Kendle, Strand Genomics, Invitrogen, Concordas, Manipal Acunova, NASDAQ, Ocimum Biosolutions, and Polyclone.   ]]> <![CDATA[AP may see $136-million biotech investment in the next five years]]> https://biospectrumindia.com/news/95/2324/ap-may-see-136-million-biotech-investment-in-the-next-five-years.html https://biospectrumindia.com/news/95/2324/ap-may-see-136-million-biotech-investment-in-the-next-five-years.html Wed, 15 Mar 2006 10:23:00 +0530 AP may see AP may see $136-million biotech investment in the next five years Robert Kilpatrick receiving a memento from Lakshmi Parthasarathy, principal secretary, Ministry of Industries, Government of Andhra Pradesh. BioAsia 2006 attracted over 500 delegates, 58 sponsors and exhibitors and 12000 visitors from 33 countries, reflecting the mood of the biotech industry to collaborate across boundaries. The state of Andhra Pradesh has witnessed a cumulative investment of approximately $220.7 million (Rs 1000 crore) since 2002. Extrapolating the same, it is estimated that the same companies will invest around $1360 million (about Rs 6,000 crore) in the next five years," said Dr Geeta Reddy, minister of tourism and industries, Government of Andhra Pradesh. Speaking after inaugurating the three-day third in series BioAsia 2006, an annual biotech event organized by the Government of Andhra Pradesh in Hyderabad on February 9, 2006, she said, "Andhra Pradesh today has the proud privilege of being regarded as the number one Bio State of the country and Genome Valley is the first international biotech cluster in the country, which has attracted attention globally. We've consistently pursued proactive policies and undertaken several initiatives to support and promote the biotechnology sector in the state. The state government is providing an additional 300 acres of space for Genome Valley Biotech Park at Medak district." Delivering the keynote address, Dr MK Bhan, secretary, Department of Biotechnology, outlined the strong measures taken for the promotion of biotechnology by the Indian government and highlighted the role it could play in fulfilling current societal needs by way of generating wealth and employment. He said, "The government has been working on issues on human resources besides other issues like regulatory, setting up of business incubators and biotech parks. It has set up many groups and also allocated resources to rapidly develop initiatives to meet the requirements of the industry." Addressing the gathering, Dr Anwar Nasim, chairman, National Commission on Biotechnology of Pakistan and president of Federation of Asian Biotechnology Associations (FABA), said, "We are committed for the growth of biotechnology in Asian countries. Four more countries â€“ Japan, Korea, Indonesia and Bangladesh - have joined FABA in the last one year. With this the number of members to FABA has increased to 14. The increase in membership has strengthened and boosted our initiatives. We have also formed a tripartite committee between USA-Indiaâ€“Pakistan to promote biotechnology research activities in the region." Commenting on the growing co-operation among Asian biotech countries, Dr Anwar Nasim, said, "BioAsia has played a significant role in creating a platform for Asian biotech companies to interact and collaborate. We are delighted to see that the formation of FABA has specially brought India and Pakistan close in the area of biotechnology." On the occasion, Dr Geeta Reddy presented the Genome Valley Excellence Award â€“ 2006 to Dr Guntaka Rama Reddy, Department of Molecular Sciences, College of Medicine, University of Tennessee Health Science Center, Memphis, for his contributions in the field of biotechnology. The US-settled bioscientist of Indian origin is currently working to develop a vaccine for Hepatitis-C. Prof Guntaka was part of the four-member team that discovered proto-oncogenes, the genes that cause cancer. J Michael Bishop and Harold E Varmus, one of the two members, received Nobel Prize for medicine in 1989. Dr MS Swaminathan and Dr William Rutter were the first recipients of the award instituted in 2004 by the Government of Andhra Pradesh. In 2005, the award went to Prof William Haseltine. Dr Geeta Reddy also released a Compendium of Biotechnology Organizations in Andhra Pradesh compiled by Ernst & Young and newsletter gene Hap brought out by the Department of Biotechnology, Government of Andhra Pradesh. BioAsia 2007 website unveiled After three days of sessions and exhibits, BioAsia 2006 came to a close on February 11, 2006. Speaking at the valedictory function, Lakshmi Parthasarathy, principal secretary, Ministry of Industries, Government of Andhra Pradesh, said, "The summit has lived up to its promise of being a platform for bridging the Asian and global biotech communities. We have been successful in attracting over 500 delegates, 58 sponsors and exhibitors and 12000 visitors from 33 countries that reflects the mood of the biotech industry to collaborate across boundaries. We plan to take this success to new heights in the years to come." On the Sidelines Panel stresses on biocluster development On the first day of BioAsia 2006, ICICI Knowledge Park hosted a panel discussion on Bio Parks at Genome Valley. Dr MK Bhan, secretary, Department of Biotechnology, Government of India along with the state representatives from Uttaranchal, Maharashtra, Punjab, Delhi and West Bengal discussed the significance of biocluster development in India. He emphasized the need for states and the Centre to work in synergy in pursuit of creating a biocluster. There was also a need felt for world-class quality training centers for clinical trial investigation. And it was decided to identify a top medical college in each state to elevate it to a Center of Excellence with state-of-the-art technology and research facilities. The panel decided to set up Bio Parks Authority of India, steered by a high powered committee, along the lines of Software Technology Parks of India, to bring down bureaucratic delays and clear the hurdles in the implementation of biotech parks. Dr Bhan assured the Andhra Pradesh government of all the support and co-operation for the setting up of a clinical research trials institute to address the needs of drug discovery companies in the state. TiE launches Hyderabad Biotech Chapter On the second day of BioAsia 2006, The Indus Entrepreneurs (TiE) launched its Hyderabad Biotech Chapter. The chapter will work in synergy with the Indian School of Business and Ernst & Young to promote promising entrepreneurs in the field of biotechnology by providing them the right opportunities. Srinivas Akkaraju from JP Morgan Partners will support the TiE Hyderabad Biotech Chapter from the US. Speaking at the launch of the Hyderabad Biotech Chapter, J A Chowdhary said, "It was only imperative for us to start the biotech chapter here considering the frenzy of activities happening in the city of Hyderabad in the area of biotechnology. We received about 60 business proposals last year, out of which about 12 people were asked to make their presentations. Two-three of these are likely to get their funding too very shortly." He further invited all budding biotech entrepreneurs to submit their business plan. These business plans will be then evaluated and short listed by the TiE-ISB Connect panel. The selected few will then be required to make presentations to a team of renowned VCs. As a success on to TiE-ISB Connect 2005, there will be another event- TiE- ISB Connect 2006 in September. However, interestingly the scope of the event has been expanded from only IT to cover retail, infrastructure and biotech as well. "Ernst & Young releases "Health Quotient" Dr YS Rajasekhara Reddy, chief minister of Andhra Pradesh, at the third Ernst & Young CEO Conclave which coincided with BioAsia 2006, released Health Quotient, an Ernst & Young report on the challenges and opportunities in the Indian pharmaceuticals, biotech and healthcare sectors. Health Quotient gives insights into the global generics market and how the untapped potential in the domestic Indian market, weapons of mass protection (vaccines) from India and a surge in medical tourism could drive the growth in this sector. "Hyderabad is a happening place in biotechnology space. We see it with a lot of opportunities for bio partnerships. And we are committed for BioAsia. We expected 100 meetings for BioAsia 2006. As many as 62 companies registered with us and at the end, 30 meetings took place at the event," said Dr Robert Lee Kilpatrick, partner, Technology Vision Group LLC. Sharing his views Dr A Ashok, director, Department of Biotechnology, Government of Andhra Pradesh said, "BioAsia 2006 achieved its objective of providing an interactive platform for academia, bio entrepreneurs, policy makers, scientists and students while strengthening the linkage between academia, research, industry and the government. It provided a forum for all stakeholders to communicate, connect and exchange trends in this sector. BioAsia 2006 was successful in creating networking opportunities, forging alliances and collaborations. It has rightly served the purpose of showcasing the Genome Valley and reiterating its status as the biotech hub of India." More than 60 eminent scientists and business leaders, from diverse backgrounds, presented and exchanged views on issues as myriad as biofuels, clinical trials, investing opportunities in biotech, venture funding et al. Amongst other topics that were discussed, special focus was on drug licensing, leveraging logistics to enhance supply chain management in pharma and biocluster development in India. The exhibition stall of Saint Gobain Performance Plastic was adjudged the best at the valedictory ceremony of BioAsia 2006. This was followed by Pooja Lab Equipments and PharmaTech Scientific Systems taking the second place and Sun Microsystems and Locus Enterprises sharing the third spot for the best exhibition stalls. Lakhmi Parthasarathy set the stage for the next year's event by unveiling the website for BioAsia 2007, which will be held from February 15-17 next year. Narayan Kulkarni in Hyderabad ]]> <![CDATA[A Disappointing Budget]]> https://biospectrumindia.com/news/95/1452/a-disappointing-budget.html https://biospectrumindia.com/news/95/1452/a-disappointing-budget.html Wed, 15 Mar 2006 10:19:00 +0530 A Disappointing Budget A Disappointing Budget Finance Minister Palaniappan Chidambaram has the biotech industry down this time. The elaborate recommendations made by ABLE and other industry associations to put the biotech industry on the growth path have not found a sympathetic ear in the finance ministry in 2006. For the research-intensive biotech industry, any decision to extend the 150 percent weighted deductions in R&D expenditure beyond 2007 for at least another five years would have been a great boon. But the finance minister, in his emphasis on fiscal prudence, is apparently not in a mood to provide any more concessions to industry sectors, including biotech. Many industry leaders had got this impression during their interactions with him in recent months and their worst fears on this score have been confirmed by the announcements or the lack of it on February 28. More than the neglect of the demands of industries like biotech, what is unfathomable is the government's decision to only lower the customs duty on life saving drugs from 15 to 5 percent. How much revenue does the finance minister hope to lose by making life saving drugs imports duty free? At the most a few million rupees. On the other hand, the government has no problem abolishing the excise duty on pasta, consumed by fewer Indians than those in need of importing life saving drugs. The biotech industry is certainly not asking for the moon. Government support is essential, either directly or indirectly, to develop cutting edge technologies that could be adapted by the industry. Most of the important innovations in the US have come out of publicly-funded laboratories or universities which are funded heavily by various government agencies. The National Institute of Health (NIH) of the US government alone provides over $40 billion a year to research projects which help the pharma and biotech industry. The Indian government's support to research efforts, in spite of running nearly a dozen departments and over 200 research institutions is nowhere comparable to even a fraction of the support given by the US government to its universities and industries. A gladdening news is the decision to make the Rajiv Gandhi Center for Biotechnology, Thiruvananthapuram an autonomous center of national importance. The change in status should lead to more federal government funds to the institution. This institution has been fortunate to be named after the leader whose name can do wonders with the current ruling coalition. The fact that the Assembly elections are due in Kerala where this center is located too may have had a part in the finance ministry's magnanimity. Two other states going to the elections, Tamil Nadu and West Bengal would be happy with the finance minister's offer to giver Rs 100 crore each to beef one department of University of Calcutta and University of Madras, along with University of Bombay. Nearly a year after a similar grant of Rs 100 crore to the Bangalore-based Indian Institute of Science(IISc), nothing much has happened on the ground in terms of its use by the institution. The CSIR has got the sanction to set up a new Rs 190-crore drug research institute even though it has got the Central Drug Research Institute (CDRI), Lucknow under its wings for over 50 years. The NMITLI program, a major source of support for the biotech industry has got more allocations which is a good news. Of course, the Union Budget is not the only opportunity to make the government work. The industry has to create other year-round opportunities to get itself heard and produce a series of white papers to highlight the importance of continued support to key initiatives which will help the biotech sector and the economy in the long run. ]]> <![CDATA[Healthcare industry will boost the Indian economy]]> https://biospectrumindia.com/news/95/2497/healthcare-industry-will-boost-the-indian-economy.html https://biospectrumindia.com/news/95/2497/healthcare-industry-will-boost-the-indian-economy.html Wed, 15 Mar 2006 10:18:00 +0530 Healthcare industry will boost the Indian economy Healthcare industry will boost the Indian economy The major factor driving the growth of manufacturing of diagnostic equipment and kits in India is the wide gap of 70-80 percent cost advantage that Indian labs offer over countries like the UK and the US. Suresh Vazirani Managing Director, Transasia Bio-Medicals Ltd Good times lie ahead for India's health care services industry. Grow ing at a rapid pace it is poised to emerge as one of the future growth drivers of the economy. The Indian government expects the $17-billion Indian healthcare industry (roughly 4 percent of the country's gross domestic product), which comprises hospital services, healthcare equipment, managed care and pharmaceuticals, to grow at a rate of 13 percent annually for the next five years. With global revenues of an estimated $2.8 trillion, the healthcare industry is the world's largest industry. India's high population makes it an important player in this industry. According to the Insurance Regulatory and Development Authority, the Indian healthcare industry has the potential to show the same exponential growth that the software and pharmaceutical industries have shown in the past decade. Only 10 per cent of the market potential has been tapped till date. This itself should be a pointer of the growth prospects. The last few years have seen a rise in the purchasing power of the middle class. With an erratic urban lifestyle, healthcare is on the top of everyone's list. This combined with the availability of high-class healthcare facilities, thanks to the involvement of the private sector, has seen a distinct willingness to spend more on healthcare. India's expenditure on health, in terms of percentage of GDP, is among the highest for developing countries. Add to this the vast difference in costs between Indian and Western countries, India is being seen as the preferred destination for quality health solutions. The pathology market is currently 2.5 per cent of the overall healthcare delivery market. There are 40,000 independent pathology labs in the country and around 70 per cent of treatment decisions in the country are based on lab results. The Government of India's National Health Policy (2002) envisages an overall increase in health spending to 6 percent of GDP by 2010, of which one-third would be committed to public health investment. The Policy aims at widening the extent and coverage of care. It also envisions a greater role for the private sector in the urban primary care and tertiary care sectors with growth of private health insurance. India is on the cusp of another outsourcing wave: high-end laboratory and diagnostic testing. For hospitals in the UK and the US it is cheaper to outsource laboratory and diagnostic tests to India. This is the case in West Asia as well. The major factor that is driving the growth of manufacturing of diagnostic equipment and kits in India is the wide gap of 70-80 percent cost advantage that Indian laboratories offer over countries like the UK and the US. In this segment Indian service providers are offering highly specialized tests like molecular diagnostics for autoimmune disorders, cytogenetics or diseases related to abnormalities in chromosomes and hormones. The net is widening to include cancer, HIV, tumor and hepatitis marker tests. Indian labs offer a comprehensive test menu - over 1,500 tests under one roof. Outsourcing of laboratory testing and diagnostic services is set to become big business in India. According to a study by SKP Crossborder Consulting on the Indian healthcare industry, the $864-million diagnostics and pathology laboratory-testing business is growing at a CAGR of 20 percent. At present there are about 25 companies manufacturing diagnostic kits and equipment in the country. Transasia Bio-Medicals Ltd leads this segment from the front and has seen a phenomenal growth in the past five years. We have attained market leadership on the strength of our quality, service and R&D policies. Due recognition of these parameters over the years by the governing authorities is testimony of our absolute commitment to delivering quality products and services worldwide. Our 26-year-old track record enables us to understand the needs of this industry and be a step ahead of the competition in all spheres. We have expanded our horizons and today are exporting to about 50 countries all over the world. The IVD (in-vitro-diagnostics) market has grown from $147 million in 2002-03 to approximately $285 million this year. With greater awareness and preference for better healthcare facilities, the growth should be healthy and the IVD market should be worth around $455 million by 2010, realistically speaking. However, if the environment continues to be conducive to the CAGR of around 25 percent as it has been since the last three years, then a figure of around $700 million by 2010, could be attainable. And the sustenance story will continue with the next big success story out of India â€“ medical tourism. An estimated 120,000 medical tourists came to India last year and a CII-McKinsey report suggests that medical tourism could be as big as a $2 billion industry by 2012. Currently this segment is estimated to be around $333 million. Analysts and industry watchers alike feel that this is just the tip of the iceberg and taking into consideration the allied indirect benefits to industries like aviation, hotels and tourism, the actual scenario could be more than what meets the eye. Indian diagnostics sector estimated to grow at 30-40 percent Dr Shama Bhat, chairman and managing director, Bhat Biotech shares the data on the diagnostic sector The world-wide diagnostics market is estimated at $24 billion and the Indian market is $100 million. The annual growth of diagnostic industry in India is growing at the rate of 30-40 percent. This excludes diagnostic equipment such as MRI and CT scan. The trend today is towards immunochromatography tests, PCR (Polymerase Chain Reaction), biosensor-based tests, luminiscense, DNA micro arrays, protein micro arrays and reagent free analysis. ]]> <![CDATA[More big deals in generics space, predicts E&Y]]> https://biospectrumindia.com/news/95/2526/more-big-deals-in-generics-space-predicts-ey.html https://biospectrumindia.com/news/95/2526/more-big-deals-in-generics-space-predicts-ey.html Wed, 15 Mar 2006 10:16:00 +0530 More big deals in generics space More big deals in generics space, predicts E&Y With more than 75 US FDA approved plants to its credit, India has the highest number of Drug Master Filings (DMF) and US FDA approved plants outside the US. Utkarsh Palnitkar Director, Life Sciences, Ernst & Young India The global generics industry is witness- ing significant M&A activity, with 2004 and 2005 reporting a strong trend of consolidation. Through some of the highest transactions in history, Teva and Sandoz have emerged as generics leaders. This trend is likely to continue in the current year with some specific deals valued at $500 million, according to a special report, Health Quotient, released by global consultants, Ernst & Young on February 10, 2006. The momentum in the consolidation activity in the global pharma generics sector is likely to continue into the future. A majority of the deals of global generic market leaders have been with an objective to expand into newer geographies. A relevant example here is Actavis which has executed 20 acquisitions (including those of local distributors) in the past six years. This strategy has helped Actavis make the successful transition from being a small Icelanding player to becoming an established global force with approximately $1.8 billion in market capitalization. A few of the recent deals have also been executed with the specific intent of acquiring injectible capabilities. These are: Sandoz's acquisition of the Canadian firm Sabex Holdings in 2004, where Sabex had developed injectible generic drugs like vitamins, morphine and penicillin. Teva's acquisition of Sicor, a Nasdaq listed US firm in 2003. Sicor provided a platform for Teva in the lucrative US market for injectible generics. Additionally, Sicor also had attractive business in Active Pharmaceutical Ingredients (APIs) and biogenerics. With its acquisition of Israel-based Agis Industries in 2004, Perrigo inherited a strong topical portfolio of generics such as ointments and creams. Vertical integration and India angle Vertical integration into APIs is gathering steam. While most generic companies are seeing intense pressure on pricing and a sharp erosion in margins for finished dosage products, the comparative profitability for APIs is more sustainable. Leading generics players like Ranbaxy, Actavis, Richter Gedeon, Teva and Cipla, which also have API manufacturing capabililties, have demonstrated better resilience in their overall margins. Increasingly, API suppliers are evolving into integrated players and posing direct competition to companies manufacturing finished form generics. A case in point is the recent acquisition by Matrix of Belgium-based Doc Pharma. It is expected that the interest of global generic majors in Indian companies would be driven by this factor. All large Indian companies are integrated with strong API cash flows and US Food and Drug Administration (FDA) approved assets. With more than 75 US FDA approved plants to its credit, India has the highest number of Drug Master Filings (DMF) and US FDA approved plants outside the US. Exploring specialty pharma options A different strategy being followed by generics companies is to use cash flows from generics to acquire proprietary drug development capabilities or evaluate investments in pharmaceuticals companies/business models which focus on one therapeutic segment. Endo Pharma, a $600-million US-based company, focuses largely on pain management. Industry analysts estimate that generic deals have been done at an average EV/EBITDA multiples greater than 12. While several deals have been executed, interest in smaller deals continues. Several Indian companies continue to evaluate deal options in Europe with values ranging from $20-50 million. Next wave of consolidation India is set to be a key player in the next phase of consolidation. We expect several local players to be attractive targets for the following reasons: Indian pharma companies are emerging as strong, fully integrated players, holding their own in the global market, producing high quality products at " approved sites" in other regulated markets. According to some estimates, Indian companies have invested a combined capital expenditure of $1 billion between Financial Year 2003 and 2005, a majority of which is in FDA-approved assets. This would enhance India's attractiveness. India has a long tradition of manufacturing generics and knowledge of Good Manufacturing Practices (GMP). Almost all major Indian companies are integrated players, with profitable API businesses. Indian firms accounted for 35 percent of the DMF filings in 2004 with the US FDA. Global generics companies consider API integration factor as critical for long-term competitive advantage. Post the Ivax deal , Teva has become the market leader with sales of over $7 billion, followed by Sandoz at $3 billion. All other players are currently in the $1.3 -1.6 billion range and would be looking to catapult to the big league. A recent research report brings forth an interesting fact. Some of the larger Indian pharma companies make better margins from their operations in Russia as compared to the US or Europe. Also, several Indian pharma companies have a strong presence in different geographies. Thus, investment in these companies would also help to diversify the geographical risk of the global generic majors. Major changes preceded Budget: E&Y Finance minister P Chidambaram has successfully placed this year's Union budget without creating much political noise but his actions over last few months reveal it to be a continual process, industry experts said. Rahul Roy, director of Ernst & Young India, said, "On its face, this year's budget might not be having any major announcement that might otherwise would have generated political noise. Closer study of moves taken by the Union government over the last few months shows that it has just been a continuous process." "Steps have been taken allowing FDI in several areas during last few months, which could have been part of the Union budget, but then that would have led to political disturbance. The Budget was kept 'uneventful' in that way," explained Roy. "A lot has already been done before the budget and so it should not be evaluated in isolation. The finance minister has already laid foundation stone and the success would depend on how efficiently the FM could continue with his objective without much of political noise," he added. Referring to infrastructure bottlenecks, Roy said Indian ports needed to expand by 140 per cent to handle the growing traffic. Given the good monsoon, agriculture growth should have been higher than actually achieved, he pointed out. ]]> <![CDATA[What will it take for a resident Indian to win a Nobel Prize]]> https://biospectrumindia.com/news/95/2575/what-will-it-take-for-a-resident-indian-to-win-a-nobel-prize.html https://biospectrumindia.com/news/95/2575/what-will-it-take-for-a-resident-indian-to-win-a-nobel-prize.html Wed, 15 Mar 2006 10:15:00 +0530 What will it take for a resident Indian to win a Nobel Prize What will it take for a resident Indian to win a Nobel Prize Saying merely the first or the last word in science is not enough. What one says must have a lasting and indelible impact on the field! Dr RA Mashelkar President Indian National Science Academy & Director General Council of Scientific & Industrial Research It was in June 1998 that I met Amartya Sen for the first time at India International Centre in Delhi. At the end of our brief conversation, I said, "I hope this will be the year for the big one." My reference was to the Nobel Prize. He laughed and said, "do you know Dr Mashelkar, you have to be ten times as good to win the Nobel Prize, if you are an Indian!" In the same year in October 1998, the Nobel Prize in Economics was declared. Amartya Sen won the prize. I remember sending him a one-line congratulatory message "after all you were ten times as good!" The will of Alfred Nobel dated 27th November 1895 states clearly that "in awarding the prizes no consideration be given to the nationality of the candidate." Therefore, more seriously, if the breakthroughs are truly Nobel Prize-worthy, then there is no reason as to why a scientist should not get it despite his nationality. But what does history tell us? In more than 100 years, 776 Nobel prizes have been awarded till the year 2005. In science, only three of them have gone to the 'developing countries' for the work done in their respective countries. One of them happens to be our own Sir CV Raman. This is not an encouraging statistics. Let us return to the issue of an Indian winning a Nobel prize again. This year the Nobel Prize in Physics has been shared by Roy Glauber, John Hall and Theodor Hansch. Glauber is the winner of half of the Noble Prize "for his contribution to quantum theory of optical coherence." This has raised a controversy since it was felt by some that contribution of ECG Sudarshan, a scientist of Indian origin in the US, has been overlooked by the Nobel Committee. Sudarshan himself has written to the Nobel Committee saying "it would distress him and many others if extra scientific considerations were responsible for this decision". Some Indian scientists have also formally protested to the Nobel Foundation. In science, they say that only two people will be remembered, those who say the first word in science and those who say the last word in science. Of course, saying merely the first or the last word is not enough. What one says must have a lasting and indelible impact on the field! Did Sudarshan say the first word? The Nobel committee says "Sudarshan drew the approach to the use of coherent state representations for the approach to classical physics, at this point, he refers to Glauber's work". Thus, the committee is subtly suggesting that Glauber had said the first word! These subtleties are beyond me, since I am not an expert. But the implied emphasis on saying the first word is clear. As an Indian, I would have been truly proud if Sudarshan had won the Nobel Prize, as did so many other scientists in the past, who deserved it. What does our past history say? Jayant Narlikar has written a book The Scientific Edge, which has been published by Penguin (2003). He lists the top ten achievements of Indian science and technology in the 20th Century. There are five before 1950 and five after 1950. Interestingly, the five before 1950 are all individual efforts, namely, the work by Ramanujam (mathematics), Meghnad Saha (ionization equation), SN Bose (particle statistics), CV Raman (Raman Effect) and G.N Ramachandran (molecular biophysics). After 1950, he lists the other five achievements as nuclear power, green revolution, space program, superconductivity and CSIR's transformation. All these five are government-funded big team initiatives. The moot question is â€“ what has happened to individual excellence after 1950? However, if one looks at what happened before 1950, CV Raman did get the Nobel Prize but others did not. SN Bose's work leading to Bose-Einstein condensate is winning Nobel prizes today. Many Indians feel that GN Ramachandran's work on triple helix should have won him the Nobel prize, but he did not. Let us look at the history of Nobel prizes. There are three Nobel prizes for 'sciences', one each in chemistry, physics and medicine. In chemistry, of the total 152 prizes, 54 went to the US alone, followed by Germany 27 and the UK 25. Similarly in physics, of the total 182 prizes, 79 went to the US alone, followed by Germany 23 and the UK 21. Similar is the story with Nobel prizes in medicine. Of the total of 186, 89 went to the US followed by the UK 24 and Germany 15. Why is the US the leader? Why that other economic superpower Japan has not been as successful? Many people believe that this has to do with the culture of questioning that exists in the US as against the culture of compliance that exists in Japan. A potential Nobel laureate needs to be, first and foremost, a true innovator. What is the definition of a true innovator? Innovator is one who does not know that it cannot be done. Bednorz and Muller won the Nobel Prize because they tested materials, which through accepted wisdom, were not supposed to show superconductivity! Innovator is also one who sees what everyone sees but thinks of what no one else thinks. Look at this year's Nobel Prize winners for medicine, Robin Warren and Barry Marshall. Everyone had thought that the cause of gastritis inflammation and stomach ulceration is excessive acid secretion due to irregularities in diet and life style. Warren & Marshall postulated that the causative agent was in fact a bacterium called Heliobacter pylori. They were ridiculed but they stuck to their guns. They could see and think beyond what others saw and thought. Indians can always argue that we do not win Nobel prizes, because our investment levels are low. The US spends $250 billion on R&D as against India's $5 billion dollars. Size of the funding is, of course, important. You build large critical mass in a given field, setting up a competition. You empower the scientists hugely with modern tools so that they can run faster and arrive at the results first. But to me, it is not the size of funding but the size of ideas that ultimately matters. If tomorrow any Indian thinks of an out-of-the-box idea to get a material, which shows superconductivity at 20ºC, he cannot be denied the Nobel prize, even if he is an Indian, so profound will be the impact of his discovery on our lives! The question is how do we make people think out-of-the-box? I tried to promote this when I was the Director of National Chemical Laboratory. We created a "kite flying fund", where an out-of-the-box idea with a chance of success of one in one thousand will be supported. When I moved to CSIR, I created "New Idea Fund" with a similar objective. Eventually, I found that it was not lack of funds but it was lack of ideas that was the bottleneck! One corollary of the statistics that I have cited is that the traditional and conservative societies, which include China and Japan along with India, appear to be at a disadvantage for a fundamental reason â€“ namely the culture. But can this culture be changed? I believe we can. But we do require a change at all levels right from school science education to the way we fund and the way we do research. We have to remold the school science education to the mode of "learning by discovery" and 'learning by doing' in contrast to the prevailing "learning by rote" method. Rather than memorizing the products of science, the child needs to learn the beautiful process of science. Questioning and dissent in the classroom and at home must be respected and not punished. Indian scientists and institutions are risk averse. We must take risks. We must be more tolerant of failures. A certain amount of irreverence is essential for creative pursuit in science. True pathbreakers in science will refuse to preserve the status quo because they enjoy the fun of creation of new ideas and destruction of old dogmas. We need to identify and support such scientists to the hilt. Eliticism in science needs to be promoted. A potential Einstein or a Ramanujam will have to be identified and nurtured from early on just as the genius of Sachin Tendulkar was recognized at the age of fourteen! There is nothing like "intellectual democracy". Our current research funding pattern, which is too conservative and democratic today needs to change. Out-of-the-box thinking needs to be done not only by scientists but also by those who manage science too! Can we speculate about the potential Nobel laureates from among the current resident Indians? In a recent survey, the two names that came up prominently were CNR Rao and Ashoke Sen. It augurs rather well that CNR Rao won the Dan David prize recently, which is supposed to be among prizes that get counted as being next to Nobel prize. But is there a way to predict as to whether resident Indians will be in a zone of contention? The Institute for Scientific Information (ISI) has been publishing citation analysis of each Nobel prize winner's work. All Nobel laureates tend to have exceptionally high level of productivity (articles per author), author impact (citation per author), and article impact (citations per paper). The citation data have frequently been used to forecast the future Nobel awardees. The results indicate that high rankings by citation frequency are strongly correlated with "Nobel Class" authors. In the highest percentile, eg, the top 0.1 percent of authors, a significant percentage have won the Nobel prize or go on to win the prize in later years. Unfortunately, the Indian presence in this highest percentile is rather rare. Our presence here as well as our strong presence internationally through partnerships is going to be critical. What does it take to win a Nobel prize? One of the Nobel laureates himself said that first and foremost, you have to be very clever. Second, you have to work very very hard. But thirdly, and most importantly, you have to be very very very lucky! He is absolutely right. But luck favors only the brave. In order for a resident Indian to win the Nobel Prize, Indian science must become brave. I hope the emerging brave new young India will also create some unusually brave scientists, who will go on to win Nobel prizes. ]]> <![CDATA[Animal biologicals market has the potential to surge]]> https://biospectrumindia.com/news/95/6892/animal-biologicals-market-has-the-potential-to-surge.html https://biospectrumindia.com/news/95/6892/animal-biologicals-market-has-the-potential-to-surge.html Wed, 15 Mar 2006 10:13:00 +0530 Animal biologicals market has the potential to surge Animal biologicals market has the potential to surge The Indian animal health market is expected to grow from its present level of $40 million to about $100 million in size in the next five years. KV Balasubramaniam Managing Director, Indian Immunologicals Limited (IIL), Hyderabad The animal biologicals market is generally derived from the need to control animal diseases and thereby enhance productivity of the livestock sector. As compared to the human biologicals market, it is unique in the sense that the number of animal species is large. The common species include cattle, buffalo, sheep, goat, canine, swine and poultry. A large number of animal diseases affect several of these species. These diseases are both transboundary diseases i.e. diseases that can move across geographic regions both by movement of animals and by trading in food, as also zoonotic diseases i.e. diseases which effect animals as well as human beings viz., rabies, brucellosis, tuberculosis and West Nile fever. Low market Given this picture, it would appear that animal biological products would have a large market. However, as compared to the human biologicals market of about $70 billion, of which human vaccine is about $8 billion, the animal biologicals market is only about $3.2 billion comprising largely of vaccines. This is on account of the fact that the problem of controlling animal diseases is largely the problem of the developing world, since many developed countries have eradicated a number of animal diseases namely foot and mouth disease (FMD), classical swine fever and rabies. This apart, the dependence on livestock is more in developing countries and is particularly important to poor people. Developing countries value livestock products (milk, meat, eggs) that provide income to farmers. Livestock are means of transport and traction and also important means of savings to meet crop failures and unforeseen expenses. The low market for animal vaccines is also affected by relative paucity of animal vaccines for prevention of livestock diseases, since the expensive research oriented pharmaceutical industry in western countries do not find this to be a very attractive market. Public investments in research by developing countries are also meager, which leaves much of the disease control needs unaddressed in developing countries. Indian scenario We have to look at the Indian market against this background. It is therefore not surprising that India, as a developing country, has very low salience of animal biologicals in the pharmaceutical market. At present, the domestic animal health industry is only about $225 million (Rs 1,000 crore) as against domestic pharmaceutical market of $5 billion (Rs 22,000 crore) i.e. 4.5 percent of the market. However, the domestic market for animal biologicals is about $40 million (Rs 180 crore) as compared to about $380 million (Rs 1600 crore) for human biologicals. Thus animal biologicals have a higher intramarket salience of 18 percent as against only about 8 percent for human biologicals. The salience for vaccines is even higher since most of the animal biologicals are only in vaccines. This is on account of the fact that the vaccine market for human beings is still under developed since children in India are vaccinated only against six diseases as compared to twelve in the west. Also we have a relatively large livestock population, comprising mainly of cattle and poultry, both of which are relatively better developed as compared to many other developing countries. Poultry farming in India is very organized and vaccinations are carried out against a number of poultry diseases. Likewise, vaccination against several animal diseases in cattle and sheep are also common but not similar in scale and magnitude. Key market drivers In so far as India is concerned, the key market drivers of the animal biological market are: Awareness of animal diseases among farmers In view of the low level of literacy and minimal extension and out reach programs, the awareness level among farmers in India about animal diseases is quite low. Farmers generally tend to vaccinate only when there is outbreak of diseases and not in a regular, systematic way. This is also because farming in India is widely dispersed among marginal farmers with low per unit holding. Availability of vaccines Until sometime in the past, the animal vaccine range that was available was not significant and it also did not address several animal diseases of concern. Although this situation has not significantly changed, a number of new vaccines are now produced against animal diseases. It must be understood that unlike therapeutic medicines, there are few substitutes to vaccines in prophylaxis. Affordability of products With low disposable incomes, affordability of products whether human or animal, is the most important factor driving demand in our country. This applies to animal vaccines as well. The added problem here is that the life of animals is not often treated to be important and the cost benefit of prophylaxis vs. treatment is not well understood. Thus, both affordability and appreciation of benefits of vaccination vs. treatment are deterrent to pricing. Veterinary services reach With not much of organized farming and with livestock keepers widely spread out in a large country like ours, the availability of the veterinary services close to the doorstep of farmers is an issue. Even where available, quality of such service is also a problem. Farmers tend to look to para-veterinarians and first aid workers for addressing the basic health needs of their livestock. Distribution reach Again, given the dispersed nature of the market, cost effective distribution reach is often the issue with the suppliers. This results in sketchy presence of products and often their inadequate availability in times of need. Power of buyers While the cattle market is largely dependant on institutional purchases of vaccines and biologicals, the poultry market, though better on the retail side, is still influenced by the power of large integrated producers of poultry products. As is the case with institutional purchase, price prevails over quality. Technology The progress of science and strides made in the biotechnology sector notwithstanding, research on newer animal vaccines especially to address diseases in the Indian sub-continent has been pathetic. While the human vaccine market can boast of a number of recombinant biotechnology products and combination vaccines, the animal biologicals market still largely lives on conventional vaccines based on primary cell culture or mammalian cell cultures. This contrasts with the development in the west, where we now have recombinant vaccines, (eg. against ticks ) DNA vaccine (eg. against west Nile fever) and live vector vaccines (eg. pox vector) Regulatory issues Development of animal vaccines and their manufacture is regulated in a manner similar to that of human vaccines. Although not as rigorous in pre-clinical studies and clinical trials requirements as with human vaccines, still multiple agencies are involved in approval and licensing of products. There is also a near absence of post marketing surveillance of the products introduced. This is further compounded by a weak disease monitoring and surveillance program in the country. The changing picture A review of these market drivers would tend to put the animal biologicals market un-attractive on account of its high institutional salience, low price orientation, difficult regulatory environment and low level of disease awareness. However, the next five years could well be the turning point in the growth of this industry on account of the following factors: Globalization of the Indian economy has thrown open a large number of opportunities for the food and livestock sectors. Our competitiveness can be improved only if we control a number of animal diseases. As a first step in this direction, a zoning approach for disease control has been undertaken by the government, resulting in a relatively higher growth rate of the animal biologicals market at 15 percent per annum as compared to 12 percent of the overall pharmaceutical market. With recognition that the animal husbandry sector plays a major role in the contribution of the agriculture sector to the economy, the Eleventh Five Year plan has ambitious plans to significantly increase outlays for control of animal diseases. Diseases such as Foot and Mouth (FMD), Brucellosis and Pest Des Petits Ruminants (PPR) which have high economic impact are expected to be included in the national control programs. This itself will expand the markets and enlarge its size from the present level of $40 million by an equal share in the next few years. Thrust on productivity enhancement and quality improvement programs in the livestock sector, specifically the dairy industry, will contribute to gradually increasing incomes in the hands of farmers and result in better care for their livestock. Alongside this, is the expected increase in their awareness about the better farm practices and about the need to control diseases. Increased presence of transnational companies in the Indian animal health market, in particular due to the recognition of the Indian market is growing in stature. This has been aided also by the changes to the Patent Act and the respect for intellectual property rights in India. We are witnessing MNC animal health players making a renewed presence in India. Strong growth of the canine segment, thanks to a growing number of pet owners in the country. It is expected that the pet segment will grow at 20 percent in the coming years. Improved research, especially in recombinant biotechnology which will lead to several new vaccines, among them are improved Brucellosis vaccine and PPR vaccine, coccicidiosis vaccine and combination vaccines. We will witness new product offerings, especially from the industry leader Indian Immunologicals Ltd which is leading the research efforts. Market by 2010 As a result of these changes, we can expect the Indian animal health market to grow from its present level of $40 million to about $100 million in size in the next five years till 2010. It could be argued that this could possibly decline due to the recent developments affecting the poultry sector i.e. the incidence of avian influenza in the western part of the country. However, this could be a temporary setback for two years at best, since consumption of poultry products in India which is preferred over beef or pork due to socio religious reasons, is quite low. A heightened level of surveillance would smother this adverse market. In summary, it can be said that the animal biologicals market in India has the potential to surge in the next few years, growing by nearly 20 percent per annum, resulting in a market of about $100 million. On the qualitative side, a higher level of disease awareness and externally oriented market will bring more diseases under national control programs, thus benefiting millions of livestock keepers in the country. Much, of course depends on the success of the intervention programs of the government in controlling animal diseases, new product introductions from modern biotechnology and the speed with which the poultry industry rebounds from its recent setbacks. ]]> <![CDATA[Creating biotech talent pool]]> https://biospectrumindia.com/news/95/1780/creating-biotech-talent-pool.html https://biospectrumindia.com/news/95/1780/creating-biotech-talent-pool.html Wed, 15 Mar 2006 10:12:00 +0530 Creating biotech talent pool Creating biotech talent pool It is important to create a learning program in the area of biotechnology and its ancillary fields. Dr Krishna M Ella CMD, Bharat Biotech International Ltd (BBIL) Indian biotechnology is gathering momentum. After decades spent in debating its tangible benefits, the scientific world, rediscovered its immense potential only in the last one and half decade. Indian biotech industry is expected to grow to $1.45 billion shortly. The singleâ€“minded and dedicated efforts of illustrious scientists such as Dr RA Mashelkar and Prof. G Padmanaban and others, have brought this science that can develop life-saving vaccines to combat infectious diseases and path-breaking therapeutics to counter congenital and acquired disease patterns of the world, to the forefront of scientific research and development. Over the next few years, India is slated to become a major center for custom research, and clinical and biological services. It is already the second largest manufacturer of vaccines used by children and these are exported to over 100 countries. Biotech firms in India have prepared themselves for an intense phase that would test the ultimate enterprise and intuitive knowledge of Indian scientific and industrial community in the product patent era. Human resource issues The rate at which, the biotechnology industry in India is progressing is heart-warming. But the same cannot be said about the human resource in biotechnology. There are several issues that need to be tackled to ensure the progress that has been made in this sector. The issues can be divided into main aspects: Biotech curricula Training in practical aspects Forging industry-academia partnerships Creating policy framework Creating awareness about biotechnology Nurture and promote bioentrepreneurship Biotech curricula The course content of biotechnology as a subject in India needs an immediate relook. Unlike pharma education, which is historically well established with organized syllabus, adequate lab exposure and training, Biotechnology curricula is still evolving. Due to lack of exposure, many colleges and universities in the country offering biotech courses are not offering a standardized content material. The course content seems to swing between being either too academic or too general without any specific, well-planned practical training or lab exposure. The faculty, too seem unaware of the revolutionary changes taking place in industrial biotechnology in the areas of production, R&D, GMP guidelines among others. A look at the student output in biotech reveals this: 1,50,000 M.Scs 3,50,000 B.Scs Fewer post-doctorals compared to the US Majority have no exposure to industrial research This puts biotechnology students at a disadvantage when they set out to carve their career path in the industrial sector. To fulfil the above requirements, it is important to create a learning program in the area of biotechnology and its ancillary fields. The need of the hour is to envisage a multidisciplinary curriculum that will cover all aspects of biotechnology including understanding process principles, experimentation, animal and plant technologies, bioinformatics, basics of project management, IPR issues, business values and finances in BT. Separate modules for students and corporates, which will focus on different themes, are needed. The student course will emphasize on practical hands-on training, teaching the ethics of GLP and a fundamental know-how of BT management. Training in practical aspects Unlike IT courses where lab exposure is minimal, it is imperative that we understand the significance of providing hands-on experience for biotechnology students. The BSc course in biotechnology, started in a few colleges in the country, about a decade ago, as a vocational program of the UGC, with UGC's syllabus, guidelines and financial support. But subsequently, several colleges in the country were given affiliation for BSc, biotechnology, ignoring UGC's norms regarding sanctioning vocational courses, with the same regulations and syllabus. This needs to be addressed immediately. Creating vocational courses will ensure a steady stream of HR for biotech industry. This spark off another essential aspect â€“ entrepreneurship. The state governments and the Department of Biotechnology, with the certainly feasible support from and collaboration with the industry, establish instrumentation and training centers in a few key locations in different states, where students can get trained and research workers can get instrumentation services on payment of prescribed charges so that expensive facilities required for most of education and training in biotechnology need not be duplicated. Taking one step further, it is imperative to create educational opportunities for professionals from related fields such as pharma to hone the necessary skills for creating their career path with biotechnology industry. The council could actively create educational resources, self-training modules, information about advanced courses, research and fellowship opportunities, and links to various conferences and meetings around the world. Forging industry-academia partnerships In the last two decades a new entity has emerged on the campuses of America's research universities. This entity is known as the University-Industry Research Center or UIRC. Such centers are composed of research groups whose focus is on problems that have relevance to a particular sector of industry; often the centers receive support from that industry. In 1990, more than 1,000 existed and involved more than 35,000 faculty and researchers and 17,000 PhD students. Many more exist today. Why are universities creating such centers? Strictly speaking, universities are not creating them. In an extensive survey of UIRCs, it was determined that individual faculty members, not university administrations, typically provide the impetus for the center. Motivations vary, but the need to create funding alternatives to declining or uncertain federal support is important, as is the desire to turn research efforts to a practical end. Additionally, nearly one quarter of all US PhD recipients in the sciences are finding positions in industry; so students are looking for training that is relevant to their career prospects. In India, Bharat Biotech has set such an example. The Bharat Biotech Foundation is recognized by the JNTU, Hyderabad to execute academic research through a doctoral program in biotechnology. From an institutional viewpoint, centers like the above cited ones represent one way that the value of academic research can be realized to benefit the institution. Nurture and promote bioentrepreneurship Despite the efforts of thinkers, biotechnology in India, for a long time, remained in the safe waters of premier, academic and scientific institutions. Thoughts of one scientist illustrates this - "Scientists are not supposed to think about the economic perspective on research and development projects. A scientist's work is supposed to provide scientific knowledge. Economics is quite another discipline..." This mindset has to change. This decade, which is all set to see a biotechnology boom, will belong to those who have the power to convert their dreams into reality. In other words, it will see the rise of the bioentrepreneur. The ones who will move away from the safe waters of the laboratory and convert a patentable/testable research dream into a viable business proposition. India has the potential to become very strong in biotechnology. There has been a phenomenal increase in the number of start-up companies in this area in the last five years. While the current size of the industry is $1 billion, it is expected to grow at 25-30 percent. India ranks third in Asia in patent filings. Every bioentrepreneur must thoroughly understand the grassroots features of the biotechnology sector such as research, collaboration, infrastructure, technology and commercialization capital and come up with an alternative business model to achieve success. ]]> <![CDATA[Biotech: Opportunity beckons!]]> https://biospectrumindia.com/news/95/2736/biotech-opportunity-beckons.html https://biospectrumindia.com/news/95/2736/biotech-opportunity-beckons.html Wed, 15 Mar 2006 10:08:00 +0530 Biotech Biotech: Opportunity beckons! A healthy venture capital industry is crucial for deep and sustainable growth of the biotech sector in India. Alok Gupta Country Head â€“ Life Sciences & Technology YES BANK & Hon. Regional Director (West) ABLE Notice The views expressed in this column is the view of the author and does not necessarily reflect the views or policies of YES BANK Limited and/or its associate group and subsidiaries. YES BANK makes no representation concerning and does not guarantee the source, originality, accuracy, completeness or reliability of any statement, information, data, finding, interpretation, advice, opinion, or view presented. The Indian biotechnology industry is at a nascent yet exciting stage of growth and today offers the prospect of becoming a key global outsourcing hub for the industry. However, a key stumbling block for growth of this knowledge intensive industry has been early stage risk capital. The sector has not been able to attract significant early stage investments due to a multitude of factors including risk perception, infrastructure, business models, human resources and sectoral understanding. However, over the last few years, due to increased interest levels from government, industry and investors alike, there have been some interesting developments in the industry. Early stage financiers, M&A, corporate partnering, governmental support, debt funding are all being availed of as sources of financing for the industry. Financing strategies differ from company to company based on their business models. For example, a large number of biotech companies in India are service providers and hence it is conceptually easier for them to raise financing as their revenue models are more predictable. For a classic biotech product company, there is a requirement for pre-seed and early stage finance during the "Funding Pit" life cycle phase. In India, this market is very limited in an organized form. While the government is attempting to provide systematic intervention through various innovative schemes such as SBIRI, NMITLI and agencies such as TDB, there remains a lot to be done from the private sector. A pioneering initiative in this regard has been started by the Department of Biotechnology (DBT), which launched the "Small Business Innovation Research Initiative" (SBIRI) to promote growth of biotechnology industry in India through public-private-partnership mechanisms. SBIRI targets supporting relatively high-risk proof-of-concept research and development in small and medium companies led by technocrats. The DBT has established a committee of scientists and industry personnel (including YES BANK) to evaluate projects for their technical / financial and management suitability. Models like SBIRI can help in creating an investment pipeline for later stage investors with relatively limited risk appetite. A healthy venture capital industry is crucial for deep and sustainable growth of the biotech sector in India, as it provides the impetus to the entire financial chain and future capital sources such as follow on financings, bank lending and capital markets. Over the years, corporate venture capital has also been emerging as a funding alternative for early stage companies. Some of the private sector VC funding is emerging from established pharma / biotech companies and diversified business houses experimenting to expand their technology basket following the footsteps of their more mature peers in developed economies. In order to attract investors and reach its full potential, there are certain key issues that need to be addressed including human resource development, instilling a patent culture, infrastructure development and financing models. The recent infrastructure developments in the form of biotech parks and incubators are very positive and should be progressed through public-private partnerships and government support as relevant. There is a need to develop innovative funding models such as PPP models between government and private sector and technology transfer cells at leading institutions. There also needs to be a focus on encouraging early stage investing in the sector through various fiscal incentives. Additionally, better regulatory support and deeper penetration of very innovative government schemes launched in recent past needs to be undertaken and implemented. With the right support and focus, the Indian biotech sector can emerge as a key outsourcing hub for the global life sciences and biotechnology industry. ]]> <![CDATA[BIO urges Congress to fund Biomass R&D program]]> https://biospectrumindia.com/news/95/6798/bio-urges-congress-to-fund-biomass-rd-program.html https://biospectrumindia.com/news/95/6798/bio-urges-congress-to-fund-biomass-rd-program.html Wed, 15 Mar 2006 09:58:00 +0530 BIO urges Congress to fund Biomass R BIO urges Congress to fund Biomass R&D program The Biotechnology Industry Organization (BIO) has urged Congressional appropriators to fully fund the Department of Energy Biomass and Biorefinery Systems R&D program in the President's 2007 budget request. "The biotechnology industry can play a vital role in meeting the President's stated goal of increasing America's energy security by replacing imported oil with domestically produced alternative fuels. Bringing cellulosic ethanol to the pump will require government support in biotech research and development, biorefinery construction, and market expansion," said Jim Greenwood, president and CEO, BIO. Biotech enzymes have been the key to enabling the use of crop wastes and other cellulosic matter in the production of ethanol. These advances have served to drive down the cost of this alternative fuel and increase its availability. He further said, "We need huge volumes of ethanol to enhance our energy picture. Once we add crop wastes as the new 'renewable crude oil' we can begin to significantly ramp up ethanol production above current levels. The technology is ready today and sustainable agricultural feedstocks such as corn stover and wheat straw are abundantly available in most states." "The President's biofuels initiative can help bring cellulosic ethanol to filling stations throughout the country within a few short years, if we start now to build the biorefineries needed to produce large volumes of this domestically grown fuel," Greenwood added. "Even with the demonstration of cellulosic ethanol technology, federal policy is needed to ensure market pull for alternative transportation fuels in a market dominated by petroleum. The Energy Policy Act of 2005 established several programs to create and expand the market for cellulosic ethanol. These programs should be fully implemented," Greenwood concluded. Source: www.bio.org   EuropaBio hails EU commission initiatives on biofuels Welcoming the EU Commission's initiatives on biofuels, EuropaBio, the European Association for Bioindustries said, "This initiative would boost not only the use and consumption of biofuels in Europe, but also the use of biotechnologies to produce such biofuels, especially biodiesel and bioethanol. The strategy sets out to promote research and innovation in developing bioenergy, with the focus on second-generation biofuels." "The European biotechnology industry can and will play an important role in the development of second generation biofuels. Biotechnology will mean that Europe can move progressively towards the bio-based economy, also in the energy sector," said Johan Vanhemelrijck, secretary general of EuropaBio. EuropaBio believes that in Europe it will be necessary to create and develop wide ranging partnerships between on the one hand different industrial sectors and companies from the energy, biotechnology, agro-food, engineering sectors and on the other hand farmers and the agricultural sector, authorities and public research institutes. European Technology Platforms like the Industrial Biotechnology section of the Sustainable Chemistry Technology Platform and the Plants for the Future Technology Platform which are fostering private / public partnerships and are being coordinated by EuropaBio, will play an important role. EuropaBio is also member of the Advisory Council of the European Biofuels Technology Platform, and supports the development of the initiatives announced by the EU Commission. Source: www.europabio.org   VISTECH - Victoria-Israel S&T R&D fund launched in Melbourne The Victorian Minister for Innovation, John Brumby, officially launched VISTECH, the $6-million Victoria-Israel Science and Technology R&D Fund, in Melbourne. VISTECH would initially operate as a three-year program with Israel and Victoria each providing $1-million each year â€“ with grants of up to $500,000 available for approved projects. VISTECH is the first such initiative that Israel has formed with Australian partners, and they have chosen Victoria as the innovation state to partner with. VISTECH will fund up to 50 percent of the joint R&D costs of Israeli-Victorian market- oriented projects in areas like biotechnology environmental technologies, healthcare and advanced manufacturing. Brumby said, "The establishment of VISTECH had been driven by Israel and Victoria's common focus on building innovative, knowledge-driven economies. It is vital that we harness innovation to meet the health, environmental, energy and manufacturing demands of the future and deliver more sustainable high-skilled jobs for Victoria." He further said, "However the increasing complexity and scale of leading-edge research today means that few governments, research bodies or regional economies can afford to go it alone. Victoria and Israel both face similar challenges in areas such as environmental and water sustainability; and are both positioning ourselves as knowledge-driven economies for the 21st century." "And we are both major R&D hubs with high skilled workforces and comparable innovation strengths in areas such as biomedical and agricultural biotechnology." "VISTECH has been developed to build on our mutual strengths, common challenges and existing relationships and we are very proud that Victoria is the first Australian State to sign such an agreement. VISTECH is now open for business and I invite Victorian and Israeli companies to submit new joint R&D project proposals for funding approval in 2006," Brumby said. Source: www.ausbiotech.org   BMS industry in Singapore keeps growth momentum The Biomedical Sciences (BMS) industry's manufacturing output grew to S$18 billion in 2005, a 9.8 percent increase over 2004, according to the Economic Development Board (EDB) of Singapore. The EDB's study of the BMS industry said the pharmaceuticals industry accounted for 88 percent of the total while Medical Technology enjoyed a strong 10.6 percent growth to reach S$2.1 billion in output. Employment also expanded by a healthy 8.6 percent to cross the 10,000 mark. Of the 10,200 jobs in the BMS manufacturing sector, 62 percent are in Medical Technology. Since the BMS initiative was launched in 2000, the manufacturing output, value-added and employment for the industry have grown strongly over the past five years with compounded annual growth rates (CAGR) of 23 percent, 19 percent and 12 percent respectively. The level of BMS manufacturing fixed asset investment (FAI) commitments was maintained in 2005. It reached S$859 million, up from S$849 million in the previous year. This constitutes 10.1 percent of EDB's total FAI commitments. On the other hand, BMS investment commitments in Services activities grew by over a third to reach S$149 million in total business spending (TBS) or 6 percent of EDB's total TBS commitments. The strong growth in TBS reflects the rapidly expanding base of BMS R&D activities in Singapore. BMS projects committed in 2005 contributed S$3.08 billion of expected Value Added (VA) per annum, accounting for 28.5 percent of the Total expected VA per annum in the 2005 commitments. Over 1,200 new jobs will be created when these BMS projects are fully realized. Source: www.biomed-singapore.com   China gives more thrust on GM crop studies The importance of biotech development to the country's overall economy will see China work towards finding wider applications for agricultural biotechnology in the next five years as the sector's growth is significantly important to the overall economy. "A biotech development strategy for the 11th Five-Year Guidelines (2006-10) has already been identified. Within that strategy efforts will be made to develop the biotechnological seeding of major crops - commonly known as genetically modified (GM) crops, " said Qi Chengyuan, director of the High and New Technology Department under the National Development and Reform Committee. The government of China has approved commercialization of GM cotton, tomatoes, pimientos (Spanish pepper) and a species of Morning Glory (Ipomoea cairica) in the late 1990s. Commercialized planting of Bt cotton was introduced in 1997. At present China has more than 66 percent of its fields growing Bt cotton. Source: www.china.org.cn   EMEA adopts positive opinion for biosimilars The European Medicines Agency (EMEA) has adopted the first positive opinion for a similar biological medicinal product. The product, Omnitrope, is manufactured by Sandoz GmbH and contains somatropin, a recombinant-DNA growth hormone. It is intended for the treatment of growth disturbance and growth hormone deficiency in children and adults. The Agency's scientific committee, the Committee for Medicinal Products for Human Use (CHMP) adopted the opinion at its meeting of 23-26 January 2006. The Committee considered that, in accordance with European Union requirements, Omnitrope has been shown by studies demonstrating comparable quality, safety and efficacy to be similar to a reference medicinal product already authorized in the EU, namely Genotropin. The European Commission and European Medicines Agency have worked actively over a number of years to put in place a legal and regulatory framework for similar biological medicinal products. The first guidelines on quality, non-clinical and clinical issues were adopted by the CHMP in December 2003. A general regulatory guideline on similar biological medicinal products was adopted in September 2005. Further guidelines, including guidance on specific classes of products, are planned for adoption during the first quarter of 2006. Source: www.emea.eu.int ]]> <![CDATA[The Seed Capital of India]]> https://biospectrumindia.com/news/95/7280/the-seed-capital-of-india.html https://biospectrumindia.com/news/95/7280/the-seed-capital-of-india.html Tue, 14 Feb 2006 12:42:00 +0530 The Seed Capital of India The Seed Capital of India The government's agricultural extension services to farmers and other initiatives have boosted agricultural production and productivity in Andhra Pradesh. Andhra Pradesh is endowed with rich bioresources. There are 7 agro-climatic zones across the state, with 19 major food and commercial crops grown in different parts of the state. There are more than 5000 species of trees and out of these, 2000 species are flowering trees. About 40 percent of the land is utilized for agriculture and forests in the state cover 23 percent of the land. Agriculture is the lifeline of Andhra Pradesh economy. The sector contributes over a third of the state's GSDP and provides livelihood for over 70 percent of its population. It is one of the top three rice-producing states in the country and accounts for about 12 percent of the nation's rice production. The state has a strong base in horticulture, producing a variety of condiments, fruits and vegetables such as mangoes, citrus fruits, grapes, custard apples, bananas, pineapple, tomatoes and onions. In fact, Andhra Pradesh is the second largest producer of fruits in India and one of the largest vegetable producing states in the country. Andhra Pradesh is a leading producer of a large number of cash crops such as tobacco, oil-seeds, cotton, sugarcane, cashew, mesta, turmeric and chillies. It is the "Seed State" of India, with its progressive farmers taking up production of seed for the government and private seed companies. Floriculture and the cultivation of aromatic and medicinal plants are also rapidly growing sectors. Andhra Pradesh is the second largest producer of silkworm cocoons in the country and sericulture is an important activity in the drought-prone Rayalaseema district. This is because of the relation between industry and government. The seed companies with the support from the government are making efforts to support the farming community. In agri-biotech, tissue culture for food crops and ornamental plants has been taken up in several parts of the state with considerable success. There are about half a dozen agri-biotech companies doing flourishing business in this sector in the state. Nuziveedu Seeds, one among the four-agri companies, which received the GEAC's approval for commercialization of Bt cottonseeds, has launched its Bt versions of cotton hybrid varieties in Andhra Pradesh. Besides Nuziveedu the other leading names in agri biotech space include Emergent Genetics, Fortune Biotech, MAHYCO, Prabhat Agri Biotech and Pro Agro Seeds. The presence of International Crops Research Institute for the Semi-Arid Tropics (ICRISAT) - a non-profit, non-political organization that does innovative agricultural research and capacity building for sustainable development with a wide array of partners across the globe â€“ near Hyderabad, has boosted the companies confidence in carrying out research activities. ICRISAT believes in the potential of biotechnology to enhance the speed, precision, efficiency and value addition in many aspects of its crop improvement efforts. This is especially true in addressing the complex traits that have remained intransigent to conventional breeding approaches. In addition, many of the crops under ICRISAT's mandate have had little attention paid to them especially in the biotechnology arena, and thus, it is critical that ICRISAT continues to focus efforts on these so that our clients and partners can reap the benefits of modern scientific solutions to their problems. ICRISAT has earmarked an area of 200 acres for Agri-Science Park. It is a technology commercialization arm of the ICRISAT by which it commercializes technology to help farmers in the semi-arid tropics (SAT) through partnerships with the private and public sectors. It consists of the Agri-Biotech Park of Genome Valley, the Agri-Business Incubator, a Hybrid Seeds Consortium and the SAT Eco-Venture. About 27 private seed companies have joined hands with ICRISAT to form this consortium. The state government has initiated steps to resolve the problems faced by the farm sector on a permanent basis and embarked upon many large irrigation projects that would ensure assured irrigation facilities to an additional 65 lakh acres. Besides the state government has also set up an Agriculture Technology Commission to achieve 4 percent growth in the Agriculture Sector. The steps taken by the government might bring in cheer among farmers and push the further growth of agriculture in the state.   ]]> <![CDATA[The Biotech Hub of India]]> https://biospectrumindia.com/news/95/2624/the-biotech-hub-of-india.html https://biospectrumindia.com/news/95/2624/the-biotech-hub-of-india.html Tue, 14 Feb 2006 12:41:00 +0530 The Biotech Hub of India The Biotech Hub of India The combination of the state's vision and strategic direction along with the industry's entrepreneurial enthusiasm is fuelling Andhra Pradesh's dream of making Hyderabad as India's Genome Valley. Biotechnology is one of the thrust areas for growth, identified for rapid development in Andhra Pradesh. The state is naturally endowed with one of the richest biodiversities and enjoys a dominant position in pharmaceuticals, medical sciences and healthcare. The state capital Hyderabad is home to several Centers of Excellence (CoEs) in biotech research and training. Building on an established foundation of world class infrastructure in R&D, manufacturing, healthcare and education, the Government of Andhra Pradesh initiated India's first biotech cluster in Hyderabad, the Genome Valley, setting the stage for biotech innovation and economic growth. The Genome Valley is India's first state-of-the-art biotech cluster providing world-class infrastructure to over 100 biotech companies. Spread over an area of 600 sq.km, it is a natural cluster for biotech research, training, collaboration and manufacturing activities with some of India's leading biotech institutions and companies located here. The Genome Valley encompasses established biotech parks â€“ the Shapoorji Pallonji Biotech Park and ICICI Knowledge Park. Shapoorji Pallonji Biotech Park The Shapoorji Pallonji Biotech Park houses a mix of companies involved in high-end research in biotechnology and nanotechnology, manufacturers of biopharmaceuticals and molecular diagnostic kits, apart from contract research organizations (CROs). Already about 17 companies have set up their units at the park making an investment of about Rs 400 crore. The park has roped in many global majors to set up their first India-based R&D units. The SP Biotech Park has been given EOU status and it is expecting to get the status of "Special Economic Zone", which will bring in abundant benefits to the park. About 160 acres of land constitutes the second phase of the park and developmental activities are already underway. It is expected to be completed by mid 2006. Meanwhile, it has approached the state government for an additional land of 120 acres to commence the third phase of activities. The SP Biotech Park also plans to build facilities to be used as wet laboratories. The park has already signed agreements with Cushman Weikfield, Albany, and another Boston-based company for setting up their wet lab facilities. Each lab is a module of 2,000 sft to be built on a 24,000 sft area. Besides, a modern township for residents of the Genome Valley is also being developed. The biotech park has established alliances with research laboratories and technology parks in India and abroad. This will help the units in the park in networking, technology transfers, formation of joint ventures etc. Some of the institutions with which the park has tie-ups include the Research Triangle Park, USA, Super Computing Centre, USA, Biotechnology International LLC, USA, Technologiepark Heidelberg, Germany, Biotechnologiepark Luckenwalde, Germany, Sun Micro Systems for Center of Excellence, Hyderabad. ICICI Knowledge Park Launched by ICICI Bank Ltd in partnership with the Government of Andhra Pradesh, the ICICI Knowledge park is committed to facilitating business-driven research and development. The park is spread over 200 acres of campus at Turkapally near Hyderabad. The project is being developed in phases. With full occupancy in the first two phases, the ICICI Knowledge Park is in the process of developing the third phase with an investment of Rs 7 crore to create 22,000 sft infrastructure to accommodate 13 laboratories. Already about Rs 42 crore has been invested in setting up the first two phases of the park. As many as 13 companies are operating from this park that offers land plots of varying dimensions to build research centers and pilot plants as per specific requirements of the resident companies. While the park encourages research and development in all knowledge intensive fields, the current focus of the park is in the areas of biotechnology, pharmaceuticals technology, specialty chemicals, new materials, information technology and telecommunications. The park offers fully air-conditioned modular laboratory units with standard facilities and services for establishing state-of-the-art research centers for conducting advanced scientific research.   ]]> <![CDATA[Hyderabad all set for BioAsia 2006]]> https://biospectrumindia.com/news/95/1329/hyderabad-all-set-for-bioasia-2006.html https://biospectrumindia.com/news/95/1329/hyderabad-all-set-for-bioasia-2006.html Tue, 14 Feb 2006 12:39:00 +0530 Hyderabad all set for BioAsia 2006 Hyderabad all set for BioAsia 2006 BioAsia 2006, Asia's premier biotechnology event hosted by the Government of Andhra Pradesh, will be held from February 9-11, 2006 in Hyderabad. The three-day global bio business forum will be inaugurated by Dr Y S Rajashekar Reddy, chief minister of Andhra Pradesh. BioAsia 2006 is expected to attract over 50 exhibitors, 500 conference delegates, 60 internationally acclaimed speakers and 15,000 visitors. Delegations from 33 leading biotech countries are anticipated to participate in the event. Dr MK Bhan, secretary, DBT, Dr William Haseltine, former CEO, Human Genome Sciences, Dr NK Ganguly, director general, ICMR, Nandini Tandon, MDS Capital, USA, Dr Werner Koerbitz, consultant, Austrian Biofuels Institute, Dr Antal K Hajos, managing director, ALTANA Pharma Private Ltd, Dr B Balke, CEO, MDL, and Dr Gurinder Shahi, director, Global Bio Business Initiative, University of Southern California, are some of the prominent guests speakers for the BioAsia conference. The event will see delegations from countries like Greece, Finland, and Holland participate for the first time in the event. "The success of the earlier two editions of BioAsia has given Hyderabad and the state of Andhra Pradesh as a whole, a tremendous impetus to become the biotech capital of the country. In an attempt to take forward this success, BioAsia 2006 has included some interesting modules and also entered into strategic partnerships," said BP Acharya, chairman, organizing committee, BioAsia 2006. A special session titled "Nurturing Entrepreneurship in Biotechnology" sponsored by The Indus Entrepreneurs (TiE) will feature prominent VCs like East west Capital Partners, JP Morgan Partners and MDS Capital who will share their expectations to the entrepreneurial community on making business ideas a reality. This year there will also be a focused session on "Leveraging Logistics to Enhance Biotech and Pharma Industry Competitiveness" that would be hosted by Prof. N Viswanadham, executive director, Centre for Global Logistics & Manufacturing Strategies, Indian School of Business. The objective of the session is to discover how logistics can indeed be a differentiating factor. "The supply chain networks in the pharma and biotech industries do not command the cost efficiencies of hi-tech or consumer good supply chains since logistics and supply chain best practices aspects are not given adequate attention in these industries," said Prof. Viswanadham. BioAsia 2006 in partnership with Technology Vision Group LLC will also facilitate "Business Forum" by conducting one-to-one meetings for collaboration, strategic alliances, business development, and outsourcing. Participants in BioAsia 2006 can browse through www.biopartnering.com and prepare for private meetings with potential partners before attending the conference. Through this unique feature, subscribers to this service can access the password protected area of the site and explore research partnering opportunities accessing detailed profiles on all companies and contact other users and schedule private meetings and reserve meeting space at an event. "There have been close to 85 registrations on biopartnering as of now, out of which 28 are foreign companies," said a member of this initiative. "The Andhra Pradesh government has been using the BioAsia events as a platform to recognize and acknowledge the outstanding efforts of distinguished scientists in the life sciences sector by honoring them with an award, the Genome Valley Excellence Award. This year Prof. Rama Reddy V Guntaka, Department of Molecular Sciences, College of Medicine, University of Tennessee Health Science Center, Memphis, TN will be conferred the prestigious Genome Valley Excellence Award for his outstanding contribution in the field of biotechnology," said Dr A Ashok, director of biotechnology, Government of Andhra Pradesh. This year's global bio forum is also expected to witness an active participation of state governments. Representatives from seven states across the country including Delhi, Gujarat, Maharashtra, Punjab, Tamil Nadu, Uttaranchal, and the host state, Andhra Pradesh, will come together to discuss the development of bioclusters in India during the BioParks session on the opening day. Commenting on the remarkable success achieved by the state in biotechnology, Utkarsh Palnitkar, industry leader, Health Science, Ernst & Young, said, "Several multinational life sciences companies have chosen Genome Valley after evaluating various destinations in India. Some of the leading companies who have set up shop in the Genome Valley in the last 12 months are USP, Nektar Therapeutics and AMRI. It is expected that these three companies alone will create 300 jobs in Hyderabad." And BioAsia 2006 is expected to push these investments further in the state. There is a tremendous potential for countries to initiate joint research and development activities and simultaneously establish effective trading links to expand operations. ]]> <![CDATA[AP's growth catalyst]]> https://biospectrumindia.com/news/95/2184/aps-growth-catalyst.html https://biospectrumindia.com/news/95/2184/aps-growth-catalyst.html Tue, 14 Feb 2006 12:38:00 +0530 AP AP's growth catalyst The business-friendly government of Andhra Pradesh has actively pursued the cause of the biotech industry in the state. It also created India's first biotech venture fund APIDC. The benefits of biotechnology in terms of employment generation, socio-economic development of the society are luring all state governments to make efforts to attract investments to develop proper infrastructure suitable for the emerging and niche biotechnology industry. The state governments of Maharashtra, Tamil Nadu, Karnataka, Himachal Pradesh along with Andhra Pradesh were the first to announce the state biotech policies in 2001. But after announcing policies, except for Andhra Pradesh, the other states could not do much for the industry. With continued support and initiatives from the government, the biotechnology industry in Andhra Pradesh picked up gradually. Today, the state is home to over 100 biotech companies. The Andhra Pradesh government believes that the growth of an industry depends on three building blocks or linkages namely government support, industry itself and academic R&D institutes. It prefers to act as a facilitator and catalyst. It has felt the need for a well-defined policy to forge a private-public partnership in the development of biotechnology in the state. The state government has a think tank that has experts from different fields. Dr Manju Sharma, former secretary, DBT, Dr D Balasubramanian, head of research, LV Prasad Eye Institute, Dr MV Rao, former vice-chancellor, Andhra Pradesh Agriculture University, Dr Lalji Singh, director, CCMB, Dr Seyed Hasnain, director, Centre for DNA Fingerprinting and Diagnostics, S Dhawan, representative, Biotech Park Joint Venture Company and Utkarsh Palnitkar, consultant, Ernst & Young, who are lending a helping hand in shaping the biotech development in the state. It is this approach of Andhra Pradesh that facilitates development of the biotech business in the state. Andhra Pradesh has the attitude of a business conglomerate. A quick analogy will show that the state government is the platform maker. The platform is the building block to build biotech industry. In fact the state has all the components that make it a quality platform. The state has a biotechnology policy, APIDC Venture Capital Ltd that has been providing venture capital to biotech start-ups. It has also an integrated IPR facilitating cell at ICICI Knowledge Park established is association with CII. This is to cater to the growing demands of the industries in Andhra Pradesh for patent search and analysis, patentability advisory services, IPR awareness and training. The list can stretch. The difference the state brings in business parlance is the early bird advantage. It has done all this before any other state. The state also realizes the importance of strategic alliances. For instance, it signed an agreement with Thailand to mutually promote biotech through collaboration in research and exchange of scientists and teaching professionals. This alliance would be beneficial in the area of marine biotechnology and biotech applications for aquaculture and tropical medicine. The agreement with Iowa State of USA is to leverage agribiotech and bio-medical research. Take another case. It tied up with Research Triangle Park of North Carolina. Because of this equation, companies like CiVentiChem, a contract research and drug-discovery support company, and Kard Scientific Inc. of Cambridge, USA have set shop in the Genome Valley. Another thing the state is doing is facilitating networking. In this regard it has been organizing BioAsia, an annual international conference which started in February 2004. This will enable the industry to have a platform to understand the issues and deliberate and also showcase each other's strengths. Such conferences have proved to serve as an excellent industry-academia-global networking platform. The state is also home to the Federation of Asian Biotech Association (FABA) which was launched in the second BioAsia event held in February 2005, to promote the interests of biotechnology as a science and to foster cooperation among the Asian countries and the world of biotechnology at large. With all these incentives and support from the government, the biotechnology sector in the state is doing well and concerted efforts are on to make Andhra Pradesh a leading name in the global biotech map. Narayan Kulkarni ]]> <![CDATA[AP's Centers of Excellence]]> https://biospectrumindia.com/news/95/3663/aps-centers-of-excellence.html https://biospectrumindia.com/news/95/3663/aps-centers-of-excellence.html Tue, 14 Feb 2006 12:36:00 +0530 AP AP's Centers of Excellence Andhra Pradesh has a large pool of scientific and technical manpower. It is home to a host of knowledge-driven research institutions. Over 1,100 students pass out every year from 9 universities offering courses in biotechnology. The centers of excellence (CoEs) in the state include well established national research institutions like Indian Institute of Chemical Technology (IICT), Centre for Cellular & Molecular Biology (CCMB), Centre for DNA Fingerprinting & Diagnostics(CDFD), the National Institute of Nutrition (NIN), the International Crops Research Institute for Semi-Arid Tropics (ICRISAT), Directorate of Oilseed Research, Directorate of Rice Research, LV Prasad Eye Institute, University of Hyderabad, Acharya NG Ranga Agricultural University, Andhra University, Waltair and many more like the National Academy of Agricultural Research Management (NAARM), Dr Reddy's Research Foundation (DRF), Aurobindo Research Centre, Central Tobacco Research Institute, Nizams Institute of Medical Sciences, Centre for Studies in Bioterrorism and Public Health Policy, Centre for Liver Research & Diagnostics (Deccan College of Medical Sciences), School of Life Sciences, Nagarjuna Agricultural Research & Development Institute, Central Research Institute for Dryland Agriculture (ICAR) and Centre for Plant Molecular Biology (CPMB). Indian Institute of Chemical Technology (IICT) Indian Institute of Chemical Technology has world class expertise in frontier areas of organic synthesis, catalysis, chemical process design, modeling and simulation. It offers globally competitive, environmentally friendly technologies for drugs, agrochemicals, organic and inorganic chemicals etc. Equipped with state-of-art analytical instrumentation, multipurpose pilot plants and IT systems for process analysis, simulation and optimization, IICT has 300 highly qualified scientists and technologists supported by 250 technical officers and 300 research scholars. The institute offers quick, cost-effective, high-end knowledge based services to clients in the form of contract research, consultancy and technical services. Its client base extends to several leading multinationals like DuPont and Merck and international institutions like WHO and NIH. Centre for Cellular & Molecular Biology (CCMB) Declared a Center of Excellence by UNESCO's Global Network of Molecular & Cell Biology, the Centre for Cellular & Molecular Biology provides state-of-art facilities like confocal scanning, DNA sequencing, micro array/DNA chips and proteomics. Responsible for 1200 research papers and 14 patents in India and abroad, it played a key role in development of India's first recombinant DNA-based vaccine. CCMB conducts research in new areas such as gene therapy, drug delivery systems and the human genome using advanced DNA technologies and has collaborations with international agencies such as Imperial Cancer Research Fund (UK), Volkswagen Foundation (Germany) and the National Institute of Health (USA). Centre for DNA Fingerprinting & Diagnostics (CDFD) The Centre for DNA Fingerprinting & Diagnostics is equipped with world class state-of-the-art instrumentation and computing infrastructure to facilitate working in frontier areas of life sciences research. Its Bioinformatics facility, with more than 25 data banks, is the Indian node of the European Molecular Biology Network (EMBnet). CDFD's major service components involve DNA fingerprinting, diagnostics, genome analysis and cytogenetic, bio-chemical and molecular diagnosis. It conducts human resource training and development through bioinformatics internship program for graduates and 'DNA play centers' for children. National Institute of Nutrition (NIN) The National Institute of Nutrition is a flagship institution of the Indian Council of Medical Research (ICMR). Involved in international studies and R&D programs, the institute has the best animal house in India for in-house and collaborative drug trials. It offers doctoral programs recognised by leading universities in India. It has excellent facilities for undertaking laboratory investigations covering a range of specialities like biochemistry, pathology, immunology, microbiology, toxicology. The institute is an internationally recognized center for advanced training courses in nutrition and laboratory animal sciences. International Crops Research Institute for the Semi-Arid Tropics (ICRISAT) The International Crops Research Institute for the Semi-Arid Tropics holds in trust 113,500 accessions, humanity's largest collection of different varieties of food crops at its gene bank at Patancheru, near Hyderabad. Supported by over 50 Governments, foundations and development banks, ICRISAT has an annual budget of about $24 million. With a strength of approximately 1200 staff members, the institute excels in strategic research-for-development on global issues and on international exchange of knowledge, technologies and skills. It houses a Future Harvest Centre of the Consultative Group for International Agricultural Research (CGIAR). Its national research programs are strengthened through training, apprenticeships, establishment of research networks and information exchange. Directorate of Oilseed Research The Directorate of Oilseed research is engaged in basic and strategic research in three oilseed crops viz. castor, sunflower and safflower. It is associated to the Indian Council of Agricultural Research (ICAR). Directorate of Rice Research Directorate of Rice Research (DRR), formerly All India coordinated Rice Improvement Project (AICRIP), was established by the Indian Council of Agricultural Research (ICAR) in 1965 with its national headquarters at Hyderabad to organize and coordinate multi-location testing of genetic lines and technologies for crop production and protection generated across the country. The project was elevated to Directorate of Rice Research in 1975 with an added mandate of research in the thrust areas of irrigated rice. The Directorate continues its multi-location All India Coordinated Rice Improvement Programmme (AICRIP) with active partnership of 44 funded cooperating centres affiliated to State Agricutltural Universities (SAUs), State Department of Agriculture and other Research Institutes of ICAR. Besides, over 50 voluntary centres participate in this multi-location testing program. LV Prasad Eye Institute LV Prasad Eye Institute (LVPEI) is a comprehensive eye health facility located in Hyderabad, India. Founded in October 1986 by eminent ophthalmologist Dr Gullapalli N Rao, the Institute has evolved into a world class organization, with six main areas of focus: comprehensive patient care, clinical research, sight enhancement and rehabilitation, community eye health, education, and product development. From the beginning the focus has been on extending equitable and efficient eye care to the underprivileged. The institute's charter aims at providing 50 percent of its surgical services free of cost to the economically disadvantaged. In collaboration with the World Health Organization (WHO) and the International Agency for the Prevention of Blindness (IAPB), we have designed and implemented many innovative community eye health programs. Each day, 200 people who cannot afford eye care, receive care from some of the best eye health professionals, while hundreds more benefit from LVPEI's rural affiliates and satellite clinics in urban slums. The cornerstone of progress in medical science is research and LVPEI collaborates with premier institutions globally in this area. The research program puts cutting edge technology like stem cell transplantation, to clinical application. We have also developed innovative applications of lasers to treat corneal and retinal diseases, while evolving unconventional approaches to glaucoma treatment and conducting frontline research into the molecular genetic basis of eye diseases. University of Hyderabad University of Hyderabad is a premier institute of post-graduate teaching and research, established by an Act of the Parliament of India in 1974 as a Central University. Over the years, University of Hyderabad has emerged as a top ranking institute of higher education and research in India. The "objects of the University" as envisaged in the Act are: "to disseminate and advance knowledge by providing instructional and research facilities in such branches of learning as it may deem fit and by the example of its corporate life, and in particular to make special provisions for integrated courses in humanities and science in the educational programmes of the University and to take appropriate measures for promoting inter-disciplinary studies and research in the University." With the view to increase opportunities for higher education to a wider section of our people, the University has introduced five specialized post-graduate programs under Distance Education . These courses are in the areas of Computer Science, Project Planning & Management, Environment Studies, Translation Studies and Human Rights. The admission announcement for these courses is normally released in leading dailies in October every year. Acharya NG Ranga Agricultural University The Andhra Pradesh Agricultural University (APAU) was established on June 12, 1964 at Hyderabad. O Pulla Reddy, ICS (retired) was the first Vice-Chancellor of the University. The University was formally inaugurated on March 20, 1965 by late Lal Bahadur Shastri, the then Prime Minister of India. Another significant milestone was the inauguration of the building program of the University by late Indira Gandhi, the then Prime Minister on June 23, 1966. The University was renamed as Acharya NG Ranga Agricultural University on November 7, 1996 in honor and memory of an outstanding Parliamentarian Acharya NG Ranga, who rendered remarkable selfless service for the cause of the farmers and is regarded as an outstanding educationist, ryot leader and freedom fighter. Andhra University, Waltair Andhra University is a premier university in the state of Andhra Pradesh. Its mission is to achieve excellence in teaching and research, to preserve and generate knowledge, to cultivate resolute moral values, to develop and enhance human resources, to improve the quality of life and contribute to sustainable development of the region and the nation in harmony with our culture, heritage and environment. Andhra University was established by the Andhra University Act of 1925 passed by Madras State Assembly during the British Raj. It was first established as a residential University with 20 researchers and 6 professors in Vijayawada and later moved to Waltair. It temporarily moved to Guntur during World War II. It has 5 post graduate centers and 146 affiliated colleges. Its jurisdiction is limited to the districts of Srikakulam, Vijayanagaram, Visakhapatnam, Toorpu Godavari, and Paschima Godavari.   ]]> <![CDATA[AP a hot destination for investors]]> https://biospectrumindia.com/news/95/1740/ap-a-hot-destination-for-investors.html https://biospectrumindia.com/news/95/1740/ap-a-hot-destination-for-investors.html Tue, 14 Feb 2006 12:32:00 +0530 AP a hot destination for investors AP a hot destination for investors The presence of mature biotech manufacturers and a strong representation in the bioagri sector make Andhra Pradesh a much sough-after hub. The biotech industry in Andhra Pradesh is about Rs 455 crore, contributing to nearly 10 percent of the size of the industry in India, according to the BioSpectrum-ABLE Top 20 survey of June 2005. It accounts for 24 percent of the total biotech revenue generated by companies in south India (Rs 1,898.47 crore). The survey also shows that out of the top 20 home grown biotech companies, six are from Andhra Pradesh. These six companies - Shanta Biotechnics, Bharat Biotech, Krebs Biochemicals, Indian Immunologicals, Biological E, Dr Reddy Labs, contribute about Rs 280 crore. The biotech industry in Andra Pradesh mainly comprises mainly biopharmaceutical, bioagriculture, bioinformatics, bioservices and industrial biotechnology companies. Hyderabad being the pharma capital of the south, the biopharma sector has a strong base in Andhra Pradesh and it consists of diagnostics, therapeutics, vaccines for human beings as well as for animals. More than 60 percent of the biotech companies are from the biopharmaceuticals sector. Companies such as Shanta Biotechnics, Bharat Biotech, Krebs Biochemicals, Indian Immunologicals, a leading companies in the animal biotech space, Biological E, GVK BioSciences, Jupiter Biosciences, Suven Life Sciences and Dr Reddy's Laboratories have been doing well in the biopharmaceutical space. These companies are mainly into therapeutics and vaccines business. Shanta Biotechnics is the first biotech company in the country to indigenously produce rDNA-based Hepatitis B vaccine in 1997. With this launch, there has been no looking back for the biopharmaceutical sector in India. Then came Bharat Biotech, another leading name in the Indian biotech space. With the entry of these companies' products in the Indian market, the prices for rDNA-based products have dropped drastically, making rDNA-based therapeutic products available at an affordable price. With world class manufacturing facilities for vaccines and therapeutics, companies like Aktiva Biotech, Dano Chemicals, Indian Immunologicals, Medgene Biotech, Transgene Biotek, Biological E and Virchow Biotech - all based in Hyderabad, are working on research and development of rDNA based biopharmaceuticals. The government recognizes the pioneering efforts made by a few entrepreneurs in setting up highly successful biotech companies such as Shanta Biotechnics, Bharat Biotech and Biological E. In a very short span of time, these companies have gained worldwide recognition and put Andhra Pradesh on the forefront of the biotech revolution in India. The government envisages a very active role of the private sector in the development of the biotechnology industry. The state government has been encouraging the pharma and biotech sectors to leverage the existing strengths. Vaccines and recombinant DNA products in healthcare, nutraceuticals and medicinal plant formulations are some of the areas that have been identified as key sectors for growth and long-term development. This apart, contract research and clinical trials are also promising areas. Not just the biopharma and related sector, the biotech industry is vibrant in other sectors of biotech like agriculture, industrial, informatics, marine biotechnology and services. The state has a coastline of 974 km and a continental shelf of 33,227 sq.km, a river course of over 8,500 km and large fresh water and brackish water lakes. Andhra Pradesh contributes 40 percent of India's fish exports. Currently, the state produces around 1.80 lakh tons of fish (including shrimp and other species) in the marine sector and 3.87 tons in the inland sector (including fresh water prawn). This enhances the scope for the state to emerge in the untapped space of marine biotechnology. So the government has allocated 218 acres of land for a marine biotech park at Visakhapatnam. Biogenus and Celgen have already been allotted the required land and many more companies are keen to take up ventures in the marine biotech park. In the agribiotech segment, tissue culture for food crops and ornamental plants has been taken up in several parts of the state with considerable success. There are about half a dozen agri-biotech companies doing flourishing business in this sector in the state. Nuziveedu Seeds, one among the four-agri companies to have received GEAC approval for commercialization of Bt cottonseeds, has launched its Bt versions of cotton hybrid varieties in Andhra Pradesh. The other leading names in this space include Emergent Genetics, Fortune Biotech, MAHYCO, Prabhat Agri Biotech and Pro Agro Seeds. Moving slightly away from others, Southern Online BioTechnologies has looked at opportunities in the biofuel space. And it is in the process of setting up a biodiesel project in Nalgonda district of Andhra Pradesh. Thus, abundant and diverse agriculture and forest wealth of the state, large marine resources and cattle population provide tremendous opportunities for the development of the biotech industry. The state has a strong presence of centers of excellences to nurture its growth. It offers excellent opportunities for the growth of the pharma biotechnology industry by offering trained and skilled manpower, research and development facilities, including the Indian Institute of Chemical Technology, CCMB, NIN, CDFT and many universities. With its strong base for the biopharma industry, Andhra Pradesh has attracted entrepreneurs to invest in allied sectors like clinical research, bioservices and bioinformatics that are essential for the growth of the biopharma industry. About 17 percent of the biotech companies in Andhra Pradesh are in the bioservices sector. Hyderabad-based Vimta Labs is the third largest bioservices company in India after Syngene and Quintiles India, both based in Bangalore. To name a few more, we have BioServe Biotechnologies India, a subsidiary of BioServe Biotechnologies of USA, Genotex International, Genomik Design Pharmaceuticals and Magene Life Sciences. In the bioinformatics space, companies such as Tata Consultancy Services, Ocimum Biosolutions, Satyam Computer Services, Bijam Biosciences, BioMed informatics and Celestial Technologies are offering bioinformatics tools, services and solutions to pharmaceutical and biotech companies. These companies have ensured a good growth of the sector. The Andhra Pradesh government has identified the biotech sector as one of the "Engines of Growth" in the Vision 2020 document. The government will leverage the existing strengths of the state for rapid commercialization of biotechnology to produce innovative biotech products and services in a wide range of areas. While most states are still talking about wooing investors and trying to build infrastructure or drafting biotech policies, Andhra Pradesh has already begun to think on the next step forward after putting a strong foundation for the niche biotechnology industry. The government proposes to redraft the biotech policy and introduce positive changes that would enable an investor-friendly environment. This shows the government's commitment to biotech industry. The biotech industry in Andhra Pradesh has been picking up its pace with support from the government. It is now one of the most attractive destinations for investors. Currently Andhra Pradesh is a base for over 100 companies. This is testimony to the government's initiatives and support for the biotech industry. Andra Pradesh has achieved its leadership position through a combination of making available world-class infrastructure, investor friendly policy and an enabling environment that promotes and sustains entrepreneurship in the cutting edge field of biotechnology. Narayan Kulkarni   ]]> <![CDATA[Life sciences sector in the US attracts largest investment in Q3, 2005]]> https://biospectrumindia.com/news/95/1683/life-sciences-sector-in-the-us-attracts-largest-investment-in-q3-2005.html https://biospectrumindia.com/news/95/1683/life-sciences-sector-in-the-us-attracts-largest-investment-in-q3-2005.html Thu, 09 Feb 2006 12:43:00 +0530 Life sciences sector in the US attracts largest investment in Q3 Life sciences sector in the US attracts largest investment in Q3, 2005 The life sciences sector (biotechnology and medical devices industries together) in the US outpaced the prior quarter with $1.6 billion invested in 155 companies in the third quarter of 2005, according to PricewaterhouseCoopers MoneyTree survey. For the first nine months of 2005, life sciences accounted for $4.2 billion or 26 percent of all venture investing. At the current rate, life sciences will meet or exceed 2004's total of $5.8 billion. The software industry dipped in the third quarter, but retained its position as the largest single industry category with 185 companies capturing $1.0 billion. After a jump in the second quarter, the networking industry returned to historical levels with $339 million going to 34 companies. Other major industry categories were generally consistent with or slightly below investment activity seen over the prior year. The biotech sector saw 94 deals and investments to the tune of $1.01 billion, the medical technology and equipment industry struck 61 deals in the third quarter to attract $557 million of investment. The average deal size was $10.7 million in the biotech sector, while that for the medical tech industry was $9.1 million in the third quarter. Israel's life sciences sector attracts $60 million in Q3 The life sciences sector in Israel attracted approximately $60 million in the third quarter of 2005, as compared to approximately $70 million in the previous quarter and approximately $63 million in the corresponding quarter last year, according to theKesselman & Kesselman PricewaterhouseCoopers MoneyTree Survey reports. The biotechnology sector, which only attracted $10 million in the previous quarter (raised by five companies), has succeeded in improving its performance in the third quarter, with seven companies attracting approximately $41 million. The marked increase in the total investments in this sector was mainly due to a single large deal, which amounted to approximately $25 million. In the medical devices sector, approximately $19 million was raised in Q3 by nine companies, as compared to 15 companies raising approximately $60 million in the previous quarter and 16 companies raising $31 million in the corresponding quarter last year. The average investment per company amounted to $2.1 million in the current quarter, as compared to $4 million in the previous quarter and $1.9 million in the corresponding quarter last year. M&A DEALS IN JANUARY 2006 AMDL contemplates acquisitions in China AMDL Inc., developer and marketer of tests for the early detection of cancer and other serious diseases, announced that it is continuing due diligence with Jade Capital Group, Ltd for the acquisition of Jiangxi Jade Biochemistry Pharmacy Co. Ltd and Yangbian Yiqiao Biochemistry Pharmacy Co. Ltd. Financial statements are being completed and GAAP audited statements should be completed by January/February 2006. "The company is also continuing to gather data requested by the US Food and Drug Administration. AMDL's primary objective remains receiving FDA clearance to market our DR-70 test in the US FDA clearance to market would simultaneously increase market awareness and acceptance in international markets," said Gary L Dreher, CEO, AMDL. AMDL is headquartered in Tustin, California, and is the inventor, developer and marketer of the DR-70 non-invasive cancer blood test, which has demonstrated its ability to detect the presence in humans of up to 13 cancers 84 percent of the time overall. PharmaFrontiers acquires rights for rheumatoid arthritis vaccine PharmaFrontiers Corp., Chicago-based company involved in the development and commercialization of cell therapies, announced the acquisition of an exclusive worldwide license for the intellectual property rights and research results of an autologous T cell vaccine for rheumatoid arthritis from the Shanghai Institutes for Biological Sciences (SIBS), Chinese Academy of Sciences of the People's Republic of China. The US Centers for Disease Control (CDC) estimates that more than two million adults in the US have rheumatoid arthritis, an autoimmune disease. Spending in the US on the treatment of rheumatoid arthritis is projected to grow to $9.5 billion annually by 2013, according to Decision Resources, an independent research firm focused on the pharmaceutical industry. The SIBS' initial human clinical trial results indicate that T cell vaccination induces immune responses that correlate with clinical improvements measured as reductions in ACR50 (American College Rheumatology (ACR) criteria, which measures joint swelling and tenderness and other factors such as pain and disability) and reductions in rheumatoid arthritis laboratory parameters. Pursuant to the license agreement, in exchange for an initial payment and a running royalty on the sale of commercialized products, PharmaFrontiers receives the exclusive license and all information and data related to the SIBS' clinical trials involving the T cell vaccine. PainCare acquires Desert Pain Medicine Group PainCare Holdings, Inc., a leader in the delivery of pain management solutions, including interventional pain management, minimally invasive spine surgery, orthopaedic rehabilitation, ambulatory surgery centers and diagnostics, announced that it has acquired Desert Pain Medicine Group, a California-based pain management practice operating three offices in Palm Springs, Yucca Valley and Rancho Mirage, California. Based on the pro forma historical financial performance of the practice, PainCare expects Desert Pain to contribute approximately $4 million in annual revenue and $1.2 million in operating income each year to the company. Procyon acquires Cellpep Procyon Biopharma Inc., a biotechnology company developing innovative therapeutics in the fields of cancer and HIV/AIDS, and Cellpep S.A., a French private biotechnology company developing therapeutics in oncology and infectious diseases, has announced that they have entered into a definitive acquisition agreement under which Procyon has offered to acquire all of the outstanding securities of Cellpep in exchange for a number of common shares equal to $39.1 million in value to be issued to the Cellpep shareholders. A $18.1 million concurrent private placement of special warrants and units has also been completed. Procyon also announced that it has made a secured loan of $1.9 million to fund the operations of Opep Pharma Inc., the Canadian manufacturing subsidiary of Cellpep S.A. This will allow the newly formed entity to substantially increase its future gross margin in the manufacturing area. Following the completion of the transaction, Procyon intends to change its name to Ambrilia Biopharma Inc. Norwood to acquire Bestewil Norwood Immunology Ltd, a company focused on the rejuvenation of the immune system, announced that it has entered into a call option to acquire all the share capital of Netherlands-based Bestewil Holding Ltd. Bestewil is the 100 percent owner of Virosome Biologicals Ltd. Virosome Biologicals is developing and commercializing a proprietary platform enabling technology for vaccines, which is based upon the combination of an adjuvant with virosomes - achieves a significantly enhanced immune response to an antigen challenge. The adjuvant specifically interacts with Toll-like Receptors (TLRs). The consideration for the transaction will be up to $30.7 million ($25 million in NIM shares and $6.5 million in cash), subject to achieving certain milestones. ]]> <![CDATA["We are in the business of minimizing risks for biopharma companies"]]> https://biospectrumindia.com/news/95/1005/we-are-in-the-business-of-minimizing-risks-for-biopharma-companies.html https://biospectrumindia.com/news/95/1005/we-are-in-the-business-of-minimizing-risks-for-biopharma-companies.html Thu, 09 Feb 2006 12:41:00 +0530 New Page 1 "We are in the business of minimizing risks for biopharma companies" Jaswinder Chadha, founder president and CEO, marketRx marketRx assists the pharma and life sciences industry in improving the effectiveness of their sales and marketing initiatives. The company operates out of the US and India, with a growing presence in Europe and developing markets around the globe. In 2004 marketRx was recognized as the Rising Star in New Jersey's Deloitte & Touche Technology's Fast 50 program and in 2005 it was ranked 195th in the Inc. 500 list of "Fastest-Growing Private Companies" in the US. Jaswinder Chadha elaborates on the services rendered by the company and its future goals. Jaswinder was awarded the "Ernst & Young New Jersey Entrepreneur of the Year" award for emerging growth in 2004. What made you venture into this novel arena and what is the positioning of marketRx? I started my career working for a sales consultant company in New Jersey. I saw that the level of technology and analytics being leveraged in the pharma industry was very primitive as compared to the other industries, which have really done well in understanding the customer behavior and launching the brands. And I thought this provided a unique opportunity. Essentially marketRx is in the area of providing commercialization services to the biopharmaceutical industry. Presently the industry spends almost the same amount on sales, marketing and commercialization of products as it does on drug discovery, development and manufacturing. We saw the need to bring better processes, analytics and technology to make the commercialization more effective and efficient. Thus the pharma companies hire marketRx to help them launch new brands, plan for their sales and marketing, do analysis for their current promotions and manage their existing portfolio. As the cost in the industry has skyrocketed, there is increased competition in almost every business area - biopharmaceuticals, biotechnology and medical devices. There are more products in every category than there have ever been. The industry is highly competitive and a company cannot afford to take huge risks without having market facts in place. marketRx is in the business of minimizing the risks and making available a world-class process, system, and ecosystem to launch a brand and nurture it to a successful and profitable lifecycle. What is the range of services that marketRx offers? marketRx is a pioneer in the remotely delivered knowledge services. We combine technology, analytics and market research to provide solutions that enable our customers in the pharmaceutical and biotech industry to improve effectiveness and optimize return of their sales and marketing initiatives. In one way, we do not do any sales and marketing, we just make it better. So we do not sell or market anything for our customers but we improve the sales and marketing for the biopharmaceutical industry. We cover the areas of sales marketing as well as trade relations. On the sales front - it is planning for the sales forces; its size and structure; where should they be deployed, in which territories; which doctors or health care professional should the products be promoted to; how to track the product promotion and measure its impact; how to plan and disburse performance linked variable incentive compensation. So the area that we are talking about is managing the sales operations for the biopharma industry. On the product management and marketing side it deals with how brand managers go about shaping their brands; planning how to increase the market share; what should be the product positioning and messaging for their brand; which channels of promotion should they use; how to track performance of various promotional channels and finally how to make their marketing more effective and profitable for the company. Are there any special offerings for biotech companies? Biotech companies that are eager to survive are presently competing in an investment-constrained environment. As a result, the biggest challenge a biotech company faces today is to achieve scale without losing the benefits of being a small organization. Emerging and fast growing companies today have a variety of options including licensing, co-promotion and even commercializing products themselves. Whether evaluating partners and licensing or considering building their own franchise, biotech and specialty pharma companies can now grow and maintain value by utilizing the commercialization outsourcing services from marketRx. We start with helping the company to evaluate all strategic options in light of the pipeline and long-term strategy. How has been the response to marketRx in India? We launched our services for the Indian companies only in 2005. So we are relatively new here but we have worked with Indian companies, helping them commercialize their products in the US. For the Indian pharma industry, which has been largely based in the back end or actually manufacturing more generic or bulk products, the Holy Grail has been in having their own brands and selling them in the world market. Hence we have been helping them in identifying the right products, the right markets, putting their portfolio together, developing the sales and marketing expertise to commercialize those brands in global markets. In the Indian market we are talking to some of the leading pharma companies and are helping them think through how to commercialize their branded products. So far we have got an overwhelming response from our potential Indian customers. A very important aspect that marketRx brings to India is the global experience. Till date we have worked in 20 countries and have dealt with nearly 60 global companies. We have launched a number of global brands worldwide and have the understanding of how people think about it in the Asia Pacific, Europe, the US or Latin America. This is particularly relevant in context of the current IPR scenario in India where the market is projected to grow very rapidly in the next five years. What was the initial response in the US when marketRx was launched? The timing of our start in the US, one could argue, was either very good or very bad. It was very bad because we started our business in an industry which was after the boom. Over the last five years the pharma industry worldwide has been in a slump. So one can argue that our timing was off target. On the other hand I think it was perfect as we are in the business of enabling our customers to do more with less. As the companies faced more increased competition, they needed to figure out how to utilize the resources better. The demand for what marketRx does is an order of magnitude bigger than what our capacity has been at any given time. This has enabled us to grow very rapidly. We started about five years ago, in 2000, and focused the first year or so in building the software products that could actually help companies in sales force planning, sales force analysis, promotion planning, market analysis and then we launched our services in 2001 and here we are, five years down the line, working with 19 of the top 20 pharma companies and three of the top five biotech companies in the world. We are one of the fastest growing companies in the US. And even after the fifth year in business, despite the fact that we have grown 200-300 percent year on year, we are growing over 50 percent in this year too. So I would say that the response has been tremendous. In retrospect, we were at the right place at the right time with the right solutions. What is your vision for the company? Our goal is to be the largest sales and marketing company in the pharmaceutical industry globally and as of now we have just scratched the surface of a huge market opportunity. We will continue to extend our repertoire by providing additional value based services in the areas where our expertise is best leveraged for our existing clients. We started from the US, which has 40 percent of the worldwide pharmaceutical market and we still have a long way to go. Last year we really started growing our business in Europe to a point that today we have our European headquarter in London. We already have three offices in the US. Two years ago we came to India more for doing product software development as well as developing a world-class delivery center to provide services to the global pharma industry. Here we realized that the two fastest emerging markets in the world, India and China, are already experiencing tremendous growth in branded biopharma products and would defiantly need solutions that marketRx provides in chalking out a strategy for commercializing these products profitably. Rolly Dureha ]]> <![CDATA[India-specific infant diarrhoea vaccine soon]]> https://biospectrumindia.com/news/95/2910/india-specific-infant-diarrhoea-vaccine-soon.html https://biospectrumindia.com/news/95/2910/india-specific-infant-diarrhoea-vaccine-soon.html Thu, 09 Feb 2006 12:24:00 +0530 India India-specific infant diarrhoea vaccine soon The first rotaviral diarrhoea vaccine specific to India completes phase-1 human clinical trial in India. The loss of fluids can be deadly unless it is treated. Most of the estimated half-million deaths each year are in poor countries. Rotavirus is the most common cause of severe dehydrating diarrhoea in in- fants and children. Among children under five years of age, it has been estimated to be responsible for an estimated two million hospitalizations, 5 lakh deaths and more than 25 million clinic visits worldwide each year. The disease contributes to about 40 percent of the total dehydrating diarrhoea disease in children. In India it causes about 1,50,000 deaths per year. There are several different serotypes of rotavirus and the prevalence of these serotypes varies by geographic region. Under the Indo-US Vaccine Action Program, two candidate vaccines 116E and I321 were developed. Candidate vaccine 116E was developed by the collaborative efforts of Dr MK Bhan, Dr Pratima Ray of the All India Institute of Medical Sciences, New Delhi, Dr Nita Bhandari of the Society for Applied Sciences, New Delhi and Dr Roger I Glass, Centre for Disease Control and Prevention, Atlanta, USA, while I321 was jointly developed by Dr C Durga Rao of the Indian Institute of Science, Bangalore and Dr Harry Greenberg of Stanford University, USA. The phase I clinical trials dealing with the safety and immunogenicity studies have been completed in adults, children and infants. The infant trials showed both vaccines to be well tolerated and safe. Vaccine take was reported in 74 percent of the recipients of 116E vaccine candidate and 40 percent recipients of I321 vaccine. Further the results revealed that the 116E-based vaccine candidate is more promising and provides up to 70 percent protection with single dose in infants, which may increase to complete protection with 2-3 doses. Although the commercialization of the Rotavirus vaccine is still a few years away, it provides hope to combat one of the most serious public health problems affecting infants and children. Dr NK Ganguly, director general, Indian Council of Medical Research, said, "The Rotavirus vaccine developed by Dr MK Bhan has entered phase-II trials in India. Rotavirus causes severe diarrhoea and this has the largest morbidity rate and hence development and use of this vaccine in India is extremely important". Hyderabad-based Bharat Biotech International has produced prototype vaccine 116E under cGMP conditions to ensure its sufficient stock for the phase II and III clinical trials. Meanwhile US-based multinational Merck and PATH, an international, non-profit organization that creates sustainable solutions to break cycles of poor health, are collaborating to conduct clinical studies of Merck's investigational rotavirus vaccine Rotateq in Asia and Africa. The clinical trial sites will be identified in Africa and Asia over the next six months, with a goal of starting at least one trial by the end of 2006. The efficacy studies of Rotateq will be conducted in regions of the world where it has not been studied before and where factors including poor nutrition and the presence of intestinal bacteria or viruses might play a role in the response to the vaccine. The studies also will assess how this vaccine fits into the range of childhood vaccine schedules used in different countries. According to Adel AF Mahmoud, chief medical advisor, vaccines and infectious diseases, Merck & Co., although rotavirus infection is as common in developed countries as it is in developing nations, most of the children who die from the effects of rotavirus, live in countries where emergency medical care such as intravenous rehydration is often less readily available. "Merck is as committed to identifying innovative ways to bring our vaccines to children in the developing world as we are to developing the innovative vaccines themselves," he said. Rotateq is Merck's investigational vaccine to protect against rotavirus gastroenteritis. It is an oral, liquid vaccine that contains five rotavirus strains â€“ G1, G2, G3, G4 and P1. These serotypes cause most rotavirus disease worldwide. Merck has submitted an application for licensure of its vaccine in more than 50 countries worldwide, including the US and the European Union. John Wecker, director of PATH's Rotavirus Vaccine Program, said, "It is our hope that demonstrating the impact of rotavirus vaccines in developing countries will ultimately reduce the potentially serious effects of this disease on children. By pooling our collective strengths, we seek to address one of the most serious public health problems affecting infants and young children worldwide". With funding from the Global Alliance for Vaccines and Immunizations (GAVI) and the Vaccine Fund, PATH established the Rotavirus Vaccine Program (RVP) in 2003. Along with its strategic partners, the World Health Organization (WHO) and the US Centers for Disease Control and Prevention (CDC), RVP is testing and developing a new model for accelerated vaccine introduction. By demonstrating to governments the impact of the disease and the promise of a vaccine, RVP will help countries make informed decisions about the use of rotavirus vaccines. At the same time RVP is working with Merck and other manufacturers to establish a consistent supply of rotavirus vaccine to meet the demand for these vaccines. Life-saving intravenous treatments to rehydrate children with severe rotavirus diarrhoea are often unavailable to many of the developing world's 575 million children under age five. Consequently, both the WHO and the Pan American Health Organization (PAHO) believe that availability of a rotavirus vaccine will be a major contribution to children across the world. Another company working actively in the Rotavirus vaccine arena is GlaxoSmithKline Biologicals (GSK Bio), one of the world's leading vaccine manufacturers. Its vaccine against rotavirus infection, Rotarix has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP), the scientific committee, which evaluates the quality, safety and efficacy of medicinal products in the European Union. A European Marketing Authorization from the European Commission could be expected from late February 2006 onwards which will make Rotarix, the first rotavirus vaccine available to children in Europe. GSK Bio submitted a registration file for Rotarix in December 2004 and intends to introduce this vaccine throughout Europe immediately after the marketing authorization has been granted. The rotavirus market potential by 2010 is estimated between £1.0-1.3 billion. Europe accounts for 20 percent of the total market. Approximately 4.5 million cases of rotavirus gastroenteritis occur every year among children under 5 years of age in the EU, which makes rotavirus the most frequent vaccine preventable illness among children in the EU. Rotarix has been developed by GSK Biologicals since 1997 when it was in-licensed from Avant Immunotherapeutics. It is probably the first human rotavirus vaccine available in the market. The vaccine which is given orally confers significant protection against rotavirus diarrhea. Clinical trials have shown high efficacy against the most prevalent rotavirus strains. Since Rotarix launch in Mexico in 2004, an additional 24 licenses have been granted worldwide (12 Latin American countries including Brazil; Philippines and Singapore being the first Asian countries). Furthermore, Rotarix has been filed in 75 countries. There are plans to file in the US where discussions are going on with the FDA. Recently, Brazil and Panama included for the first time the rotavirus vaccine in their national official vaccination calendars. Rolly Dureha Scientists grow new stem cell lines in animal cell-free culture Scientists at the WiCell Re search Institute, a private laboratory affiliated to the University of Wisconsin-Madison, have developed a precisely defined stem cell culture system free of animal cells and used it to derived two new human embryonic stem cell lines. This work reported in the journal Nature Biotechnology, helps move stem cells a small step closer to clinical reality by completely ridding the culture medium in which they are grown of animal products that could harbor viruses or other deleterious agents. Successfully growing living cells outside the body generally requires providing the cells in a lab dish with the right mix of nutrients, hormones, growth factors and blood serum. But those methods have often depended on animal cells, such as those obtained from mouse embryos in the case of embryonic stem cells, and other animal products to keep the cells alive and thriving in culture. Some scientists worry that animal viruses and other problematic agents might be taken up in the human cells and infect human patients, should those cells be used for therapy. The two new Wisconsin stem cell lines have survived for more than seven months in the new culture medium. James Thomson, senior author of the new study and a UW-Madison professor of anatomy, said that one of the new lines had an abnormal chromosome at four months while the second line initially was normal but developed an abnormality by seven months. In addition to testing the new stem cell culture medium on new lines, Thomson's group successfully cultured four existing stem cell lines in the new culture mix for extended periods, and their chromosomes remained normal. In early 2005, WiCell scientists reported that they were able to culture stem cells in the absence of mouse feeder cells, the most prominent animal product in stem cell culture systems. The new work effectively removes remaining animal products such as bovine serum and replaces them with products of human origin in a recipe that is completely defined. WiCell Research Institute is a private non-profit organization with a mission to provide human embryonic stem cells for research purposes to academic scientists all over the world. The NIH selected WiCell from a field of applicants in the United States to create the nation's first and only National Stem Cell Bank (NSCB). Plasmodium falciparum's immune evasion methods revealed The world's deadliest malaria parasite, Plasmodium falciparum, sneaks past the human immune system with the help of a wardrobe of invisibility cloaks. If a person's immune cells learn to recognize one of the parasite's many camouflage proteins, the surviving invaders can swap disguises and slip away again to cause more damage. Malaria kills an estimated 2.7 million people annually worldwide of which 75 percent of them are children in Africa. Howard Hughes Medical Institute (HHMI) international research scholars in Australia have determined how P. falciparum can turn on one cloaking gene and keep dozens of others silent until each is needed in turn. Their findings, published in Nature, reveal the mechanism of action of the genetic machinery thought to be the key to the parasite's survival. A DNA sequence near the start of a cloaking gene, known as the gene's promoter, not only turns up production of its protein, but also keeps all other cloaking genes under wraps, according to Alan Cowman and Brendan Crabb, HHMI international research scholars at the Walter and Eliza Hall Institute of Medical Research in Melbourne, Australia, and their co-authors. Malaria parasites enter human blood from infected mosquitoes. The organisms invade and promptly remodel red blood cells. They decorate the surface of the cells they occupy with a protein called PfEMP1, made by the var gene family. The diverse genetic sequences of the 60 var cloaking genes all code for remarkably similar protein structures, the malaria researcher added. The scientists are continuing to disassemble the var gene machinery, piece by piece and eventually they think their work may lead to new types of therapies that interfere with the parasite's immune evasion strategies. BioGrid project to help companies integrate data T he European Union has started a BioGrid project, which aims at gleaming useful information from the loads of data accumulated by biotechnology companies. As of now it is becoming more and more difficult to find lucid information about interactions between genes and proteins for example. The researchers involved in it have delivered a better search engine for PubMed, which includes over 16 million citations from Medline and other life science journals for biomedical articles by analyzing over-expressing genes and predicting the protein interactions that are likely occurring. The project has developed a suite of tools that will enable researchers to mine through vast quantities of data and many of the tools developed by BioGrid are available for public use. The BioGrid project brought together six partners from the UK, Germany, Cyprus and The Netherlands to address the information overload, one of the key problems facing the life sciences today. BioGrid's protein interaction software includes a database of the 20,000 known protein structures and uses that database to identify which ones could potentially interact, among the thousands of proteins created by the over-expressing genes. The researchers have developed a Gene Ontology (GO) as a vocabulary to describe all the different genetic processes and then used this vocabulary to mine through the 15,000,000 entries of PubMed. A novel way to switch therapeutic genes 'on' and 'off' Agene therapy research team at Cedars-Sinai Medical Center, California has developed a new method of signaling therapeutic genes to turn "off" or "on," a mechanism that could enable scientists to fine-tune genetic and stem cell-based therapies so that they are safer, more controllable and more effective. Although other similar signaling systems have been developed, the Cedars-Sinai research is the first to give physicians the flexibility to arbitrarily turn the gene expression on or off even in the presence of an immune response to adenovirus, as would be present in most patients undergoing clinical trials. This has been a major obstacle in bringing the testing of genetic therapies to humans in a clinical setting. In this study, researchers created a genetic switch system that is turned on in the presence of the antibiotic tetracycline. Therefore, if this method is tested eventually in humans, patients would need to be given this antibiotic before they begin gene therapy treatment. The switch system also produces a protein called silencer, which completely shuts down gene expression in the "off" state, thereby preventing leakage of the therapeutic gene when it is no longer needed. The next step in the development of this new signaling system is to activate the newly developed genetic switch to actively express compounds that are known to be effective at reversing the symptoms and rescuing the damaged neurons in Parkinson's disease patients. Researchers hope to begin a Phase 1 clinical trial in humans in the near future. New Page 1 "India could build a world-class position in understanding how genomes work" Richard J Feldmann, scientist and president of Global Determinants Inc. Richard J Feldmann, scientist and president of Global Determinants Inc., was recently in India to visit his grandchildren and to give scientific talks at the University of Madras in Chennai, and at the Institute for Bioinformatics and Applied Biotechnology (IBAB) and Indian Institute of Science (IISc) in Bangalore. Feldmann, who spent his first career developing graphical techniques for modeling proteins and nucleic acids at the US National Institutes of Heal (NIH) in Bethesda, Maryland, shared his thoughts on the results of his studies of how Connectrons control the expression of genes in mouse cells. Twenty five years ago, on his first trip to India, Feldmann spent several weeks installing software for searching crystallographic structures that he had developed on the computer at the Tata Institute of Fundamental Research (TIFR) in Mumbai. At that time, the TIFR computer was one of the few American computers in India used for doing science. Seventeen years ago in 1988, Feldmann toured India giving a scientific talk on the molecular graphic and modeling work that he had been doing. At that time he also tried to convince young Indian scientific workers to write programs for PCs that were just becoming popular. These PCs were instances of American chips in Indian computers made by Hindustan Computers Ltd (HCL). Many of the young scientific workers have now risen to prominence in Indian academia. On this trip, Feldmann said that he has brought to India a revolutionary idea about how cells function. Six years ago, he had a fundamental insight about how RNA and DNA interact to regulate the expression of genes. He has discovered four-sequence relationships that he calls Connectrons. Connectrons occur in good numbers and in important places in the genomes of many creatures. In collaboration with workers in the Genome Science Center of RIKEN in Japan, he has taken data for the transcriptome of the mouse genome and shown how DNA that does not code for proteins - the so-called Junk DNA - plays an important role in controlling how gene expression is controlled and therefore how proteins are produced. In the scientific talks that he gave, Feldmann hopes to build relationships with Indian scientists and bioinformaticians that will result in developing and proving the work that he has done. In addition, Feldmann hopes to focus entrepreneurial interest in developing applications that will eventually affect human health and food production. Feldmann was awash with stories about Connectrons and how his idea could be applied to solving problems of human health. Having been exposed to malaria for the first time on his other trips, Feldmann said that he would love to understand how the genome of the malarial parasite interacts with the human genome. The difference between his earlier trips and this trip is that now the DNA sequencing of both the malarial parasite genome and the human genome have been completed. Now with a modest amount of computing, he should be able to determine how the malarial parasite imbeds itself in the human body causing so much disease and economic loss. India's potential Feldmann argues that India is poised on the edge of the Information Age. That India is in the process of discovering how information, which travels at the speed of light, can transform the state of human health. He argues that the different layers of cellular information - first the genome, then the transcriptome and now the Connectrome - are the most powerful types of information to emerge in the last few years. With entrepreneurial help, Feldmann argues that India could build a world-class position in understanding how genomes work, in understanding how to cure many different diseases and in producing more food. Future of Connectrons "The Connectron idea of expression control seems to be very powerful. In the six years since the idea first emerged, I have performed computations on many genomes ranging from the simplest prokaryotes, symbiots and the Archea through the single-celled eukaryotes to the intermediate - and large-genome higher eukaryotes such as worm, fly, human, rat and mouse. For decades the central paradigm has been that of doing physical experiments. With the sequencing of complete genomes, it becomes possible to conduct wide-ranging computational experiments such as Connectron determination. The balance between physical and computational experimentation is shifting. My sense is that in the decades to come, scientists will first do computations that are then followed by simple physical array measurements as verification of hypotheses. Right now, patenting is hung-up on doing sample physical experiments to show the existence and utility of Connectrons. We are trying to formulate physical experiments to that end." Control of gene expression by means of Connectrons "The Connectrome of the transcriptome of a genome is the statement of how each transcript affects the expression of other transcripts. As such, the Connectrome is the logical vehicle for doing simulation of transcript dynamics. In order to accelerate progress in Connectromics, it seems that the time is right for establishing a database of all Connectromes on the Internet. Such a database would act as the support for doing simulations of generalized expression control in all genomes," he added. ]]> <![CDATA[Industry]]> https://biospectrumindia.com/news/95/1763/industry.html https://biospectrumindia.com/news/95/1763/industry.html Thu, 09 Feb 2006 12:22:00 +0530 Industry Industry's Wish List to the Finance Minister Nitin Deshmukh, head - Private Equity, Kotak Mahindra Bank and honorable director, ABLE, shares his thoughts on what the finance minister needs to consider to foster the Indian biotech industry's growth in 2006 and beyond. Duty exemption norms for imported life saving drugs and diagnostics: The components and raw materials used by indigenous manufacturers for the production of diagnostics and life saving drugs are exempt from Excise and Custom duty or alternatively duty paid on components and raw materials used in manufacture of life saving drugs be eligible for refund. Exemption on Customs Import Duty on R&D equipment and Duty refund/drawback for R&D consumables: R&D equipment as specified in List 27 A and List 28 of the Custom Notification No: 26/2003 dated 01.03.2003 by DSIR recognized Research Laboratories be expanded to cover additional items that are essential to biotech and pharmaceutical research. In addition, due to the ever-changing requirement of new types of equipment, it is recommended that additional R&D equipment not covered in List 27A and List 28 be permitted to be imported duty free based on DSIR certification. Likewise, the import of R&D consumables, reference standards and reference books be made eligible for Refund/ Duty Drawback based on DSIR certification. Weighted average tax deduction on R&D expenditure and inclusion of international patent filing costs u/s 35 (2ab): The weighted deduction be increased to 200 percent and the scheme be extended for a further period of eight years i.e. up to March 31, 2015. Further, the expenditure pertaining to International Patent filings be included u/s 35 (2AB) for weighted tax deduction for R&D. The weighted deduction under section 35(2AB) should be extended to investment made in land and buildings for dedicated research facilities. Further, the weighted deduction under section 35(2AB) should also be extended to expenditure incurred on clinical trials. Exemption of withholding tax for technology transfer and technology licensing in biotechnology: In order for Indian Companies to acquire more technology it is recommended that import of technology by the Biotech Sector be exempt from Withholding Tax for a period up to 2010. Excise duty on diagnostic kits for HIV antibodies: Diagnostic kits for HIV antibodies and other infectious diseases be also exempt from CVD/CED as it falls with the category of life saving drugs. Relaxed export obligation norms for biotech parks availing of SEZ status: The export obligation norms be made applicable after a duration of five years as this will greatly help biotech parks to attract a large number of innovative biotech companies. Minimum requirement for setting up a biotech SEZ: The minimum area required for setting up a Biotech SEZ be restricted to 25 acres of land or 1 million sft of building area, similar to the norms specified for the IT Industry. Provide two-year moratorium on obtaining price approval for products under price control: Biotech products manufactured in India be given a two-year moratorium from Price Control under NPPA to provide for sufficient time to scale up production and streamline costs. The present requirement for approval from NPPA prior to launch leads to substantial delay in launch of the product. Further, R&D expenditure incurred on biotech products be permitted for amortization in computing costs for the purposes of price fixation. Expansion of the list of capital goods under List 27 A and List 28 and easing of norms: The existing schemes be amended to cover expansion of the list of equipment provided in List 27A and List 28 to cover equipment required for manufacture of biotech products. Further, new companies be permitted to import equipment at nil duty to the extent of 25 percent of the project cost, as certified by the DBT or a recognized financial institution. The restriction of 25 percent of FOB value of exports and recognition by DSIR be waived for new companies for a period of five years from date of incorporation. Turnover limit for ssi: The limit of turnover be restricted to only dutiable goods and the excise levy become applicable only on sale of dutiable goods in excess of Rs 4 crore. Waiver of requirement of filing Form ER-5 & ER-6 under Cenvat Credit Rules 2004: Biotech companies be exempt from this requirement. Provision of a central fund (Rs 200 crore) to compensate states that provide subsidy, specifically to approved transgenic seeds: Subsidizing the seed cost, at least partially, will go a long way in the penetration of the technology among small farmers, who incidentally will stand to gain the most from such technologies. Further, subsidy for the approved varieties of transgenic seeds will also effectively curb the menace of unapproved and fake transgenic seeds, which is rampant in the country today. Priority sector lending for biotechnology: Lending to the biotechnology sector be categorized as Priority Sector Lending. Also it is proposed that Rs 200 crore of funds under the Technology Development Board be earmarked for providing long term funds to biotech companies Budgetary allocation for state supported biotech parks: Though several state governments have taken initiatives to promote biotechnology parks there is need for incentive from central government in form of budgetary allocation to support state governments in furthering the interests of biotechnology through dedicated parks. Budgetary allocation for setting up arbitration council or quasi judicial tribunals to address IPR disputes: There is need to have specially trained judicial personnel and courts to showcase India as next hub for contract research, clinical trials and contract manufacturing in biotechnology space. Budgetary allocation for setting up a world class internationally accepted accreditation agency: For India to take leap in the biotechnology space, there is need to offer quality in both manufacturing as well as services domain. This requires setting up of a internationally accepted accreditation agency, which can set standards, protocols and act as gatekeeper for producing world-quality products/services. ]]> <![CDATA[Drug discovery firms turn to Asian countries to evade stringent regulations]]> https://biospectrumindia.com/news/95/4151/drug-discovery-firms-turn-to-asian-countries-to-evade-stringent-regulations.html https://biospectrumindia.com/news/95/4151/drug-discovery-firms-turn-to-asian-countries-to-evade-stringent-regulations.html Thu, 09 Feb 2006 12:20:00 +0530 Drug discovery firms turn to Asian countries to evade stringent regulations NEWS BYTES Drug discovery firms turn to Asian countries to evade stringent regulations The Indian and Chinese drug discovery outsourcing market is riding a crest with companies from outside Asia increasingly seeking to outsource drug discovery to these countries for greater cost savings. Other major factors driving this shift to Indian and Chinese companies are better access to expertise, productivity gains, process improvements, variable costs, avoidance of capital outlays and opportunities for companies to focus on specific niches. According to Frost & Sullivan, the $7.3 billion Indian and Chinese drug outsourcing discovery market is evolving, with both gaining an edge in the global arena by producing a continual pipeline of drugs, which are approved faster than those produced in western countries. Both countries are uniquely positioned to manage and deal with the pressures to enhance clients' profitability, increase shareholder value and utilize the potential of new drug discovery technologies. The governments of these countries have also proactively worked to attract outsourcing contracts through stringent regulations, mandatory good manufacturing practice (GMP) compliance and improved legislations for clinical trials. However, regulatory bodies will have to sort out the ambiguities in regulatory issues and legislation of intellectual property (IP) rights to lure a greater number of international pharmaceutical companies. Both countries have inadequate patent protection, which can discourage global pharmaceutical and chemical companies, especially those from the US, which stand to lose $450 million every year due to piracy. "The development of patentable products requires healthy investment in R&D and suitable confidentiality of results to develop a strong IP portfolio. To ensure that technological innovation is commercialized to its best potential, companies need to continuously work with domestic government officials and key opinion leaders in establishing and defining standards to comply with regulatory standards," said Dr Amarpreet Dhiman, EMEA drug discovery technologies team leader at Frost & Sullivan. He further said that the governments' initiatives to diversify the industry's drug discovery portfolio and develop infrastructure are expected to drive the growth rate of the drug discovery outsourcing market in India and China to reach $19.8 billion in 2011. Ventiv Health, SIRO form JV to deliver clinical data management services Ventiv Health, Inc.'s Ventiv Clinical Services division and SIRO Clinpharm Pvt Ltd, India's largest domestic contract research organization (CRO), have formed Ventiv-SIRO (India), an exclusive joint venture offering drug companies India-based clinical data management services. According a release, the Ventiv-SIRO (India) joint venture brings together Ventiv's broad statistical analysis and data management services and premier client portfolio with SIRO's strength conducting large-scale Phase II-IV clinical trial data management projects. Ventiv-SIRO (India) will provide pharmaceutical and biotech companies access to a broad pool of outsourced offshore talent who will design databases, conduct data and statistical analysis and analyze medical images and scans. Dr Dilip Mehta, senior advisor to Ventiv-SIRO (India) and the former head of US clinical research for Pfizer Central Research, said, "This joint venture brings together two highly-experienced organizations that can support the clinical data management needs and enhance the productivity of pharmaceutical company R&D programs." "The joint venture broadens our capabilities, allowing us to deliver high-quality clinical research and statistical analysis services both domestically and now offshore through this joint venture with SIRO, the premier India-based CRO," said Michael Hlinak, president, Ventiv Clinical Solutions. "SIRO has steadily built its reputation as a key opinion leader and service provider in the contract research industry. Partnering with Ventiv and accessing its broad client base will offer us significant opportunities to provide high-quality, cost-effective, India-based talent and services to the companies that are researching and developing tomorrow's medicines," said Dr Gautam Daftary, executive director of SIRO. Suven's foray into drug discovery yielding path-breaking technology in CNS Since its initiation of drug discovery research program, Suven Life Sciences, a Hyderabad-based company has successfully reached the final stage of filing its first IND. The pathbreaking technology development in the area of Central Nervous System addressing the unmet medical need in the disease categories like Alzheimer, Mild Cognitive Impairment (MCI) and General Dementia has come within the short period of 36 months from the initiation of the program. Suven expects to file its first IND in the US before the end of 2006. Indian researchers working on genome sciences set up global network Realizing the need for Indian scientists devoted to genome researches to come over a single platform, a group of scientists initiated the Genome India International (GII) forum in January 2005. GII is now a fast growing global network of scientists involved in researches on various facets of genome sciences and its related fields. Its endeavor is to provide a unique and versatile platform for scientific community having similar research interests. At present the forum has around 220 bona fide members representing more than 60 research institutes/ universities across the globe. It has a devoted portal (URL: http://genome-india-intl.org/index.htm) running round the clock and updated regularly for its activities which include a discussion forum, individual member mail IDs, and a host of valuable links to resources including details on scientific meetings, openings and protocols employed in research. A number of senior scientists including Prof. MS Swaminathan, Dr RA Mashelkar, Dr NK Ganguly, Dr MK Bhan, Dr GS Khush, Dr CR Bhatia, Dr VijayRaghavan, Dr PK Ranjekar, Prof. PK Gupta, Prof. Anupam Verma, Prof. DPS Verma, Prof. SP Singh, Prof. Bhanu Chowdhary, Prof. Om Rajora, Dr Lalji Singh, Dr D Balasubramaniam, Prof. BD Singh, Prof. KS Gill, Prof. Deepak Pental, Dr SE Hasnain, Dr S Ayyappan, Prof. Swapan Datta are advising and guiding the scientists for a faster growth of the forum. Prof. Chitta Kole conceptualized the idea and initiated the network of scientists with similar interest. His mission is to hold the Indian flag high in the march past of researches on genome science and related fields. Shasun signs LOI with Rhodia Shasun Chemicals and Drugs Ltd, a service provider to the pharmaceutical industry, has entered into a Letter of Intent with the Rhodia Group of France to acquire the pharmaceutical customs synthesis business of Rhodia Pharma Solutions (RPS). Both the parties have entered into an exclusivity agreement to progress towards the final Sale and Purchase Agreement, which is expected to be completed before March 31, 2006, subject to satisfactory due diligence and regulatory approvals. A release noted that the transaction essentially includes all of RPS development and custom manufacturing services catering to innovator and emerging pharmaceutical clients in the US, Europe and Asia. The proposed transaction includes manufacturing sites at Dudley and Annan located in the UK. Ranbaxy launches Volix (Voglibose) for treatment of diabetes Ranbaxy Laboratories Ltd launched its branded product Volix (Voglibose) for the treatment of diabetes. The product, a novel Alpha-Glucosidase inhibitor introduced for the first time in India, will be available in dosages of 0.2 mg and 0.3 mg tablets. Voglibose is indicated for improvement of postprandial hyperglycemia in diabetes mellitus only when diet and/or exercise or oral hyperglycemic drug or insulin preparation in addition to diet and/or exercise, does not result in adequate glycemic control. The avoidance of high postprandial (aftermeals) blood glucose level is one of the main advantages of drug. Speaking at the launch, Sanjeev Dani, regional director, India and Middle East, Ranbaxy, said, "Volix further expands Ranbaxy's strategic diabetes portfolio and reiterates the Company's commitment to strengthen and build on its existing diabetes franchise." In July 2005, Nihon Pharmaceutical Industry Ltd (NPI), a joint venture between Ranbaxy and Nippon Chemiphar Limited (NC), launched Voglibose tablets under the brand name, Vogseal in Japan. This is Ranbaxy's first generic product in the Japanese pharmaceutical market to have gained market leadership amongst competing generic products, with a market share of 36 percent. Commenting on the launch of Volix, Dr SK Wagnoo, senior consultant diabetologist and endocrinologist, Indraprastha Apollo Hospitals, New Delhi said, "Volix (Voglibose) will provide Indian doctors with an efficacious medicine which is a strong and selective inhibitor as compared to the available 'Alpha-Glucosidase'- Acarbose. The effect of Voglibose as an inhibitor of sucrase and maltase is 190-270 times greater than that of Acarbose." Suven's net profit up by 194% Suven Life Sciences, a Hyderabad-based life sciences company, pioneer in contract research and manufacturing services (CRAMS) surpassed previous year's revenue by the end of Q3. The revenues for the nine months stood at Rs 63.45 crore, which is 104 percent of previous full year's revenue of Rs 60.77 crore. Net profit for the Q3 stood at Rs. 3.21 crore as against Rs 1.13 crore registering a 194 percent growth and the cumulative net profits up to the Q3 is Rs 6.21 crore as compared to Rs 3.20 crore for the corresponding previous period registering a 94 percent growth. The total income is at Rs 27.10 crore for this quarter against Rs. 13.94 crore of corresponding period of previous year. Panacea Biotec Q 3 Net Profit zooms by 81% Panacea Biotec has reported a remarkable performance with 81 percent rise in net profit in its unaudited financial results for the third quarter ended 31 December, 2005. Continuing its excellent show, Panacea Biotec has grown over its last year's corresponding period by a remarkable margin, posting turnover of Rs 113.07 crore and net profit of Rs 5.19 crore. Turnover during the quarter have soared by 65 percent at Rs 113.07 crore as compared to previous year's third quarter turnover of Rs 68.56 crore. Operating profit during the Q3CY is higher by 247 percent at Rs 13.93 crore as compared to Rs 4.01 crore in the corresponding quarter in the previous year. Net profit after providing for appropriations and tax, is sharply higher at Rs 5.19 crore as compared to Rs 2.86 crore in the corresponding quarter in the previous year. Profit before tax and exceptional items for nine months of the current year, has risen to a record high of Rs 78.96 crore as compared to Rs 36.57 crore during the corresponding period in the previous year recording a jump of 116 percent. For the nine months ended 31 December, 2005, turnover is at Rs 410.50 crore and net profit is at Rs 49.46 crore as against Rs 248.33 crore and Rs 22.70 crore, respectively, during the corresponding period in the previous year thus recording a growth of 65 percent and 118 percent, respectively. The nine-month period EPS (before Extra-ordinary item) stood at Rs 8.08 per share. Rajesh Jain, joint managing director, said, "This is yet another great quarter from Panacea Biotec. These results are attributable to our investments in sales and marketing combined with execution excellence. R&D continues to be an important focus and we have consistently increased our spending on R&D. Even last quarter, we have significantly increased R&D spend, and we should be able to see more benefits coming out of increased spend in the next few years. We give our scientists an environment and an opportunity whereby their capability is used effectively for producing significantly value added innovative products and technologies, and we are able to do that with relatively smaller investments compared to other companies, Jain added. Manipal AcuNova opens its clinical research center Manipal AcuNova, an emerging CRO, inaugurated its Asia Clinical Research Center at Whitefield near Bangalore on January 23, 2006. Sir William Castell, chairman, GE Healthcare, dedicated the facility. The new center marks the focus and thrust of Manipal Acunova to leverage its expertise in clinical research in the global market. The center will carry out drug development and drug discovery research. It also houses a central reference lab, radiology core lab and a cardiac safety monitoring lab. The center will have 150 professionals. DA Prasanna, vice chairman and managing director, Manipal AcuNova, said, "Today marks a milestone for us as we dedicate Manipal AcuNova's Asia Clinical Research Center at Whitefield. The growing clinical research industry in India, coupled with the vastness and reach of Manipal Group, have enabled Manipal AcuNova to achieve the growth we are seeing today. This clinical research center will bring under one roof our key offerings in drug development and research for the pharmaceutical industry. Locating the center in Bangalore, the knowledge capital helps co-locating with leading healthcare research companies like GE health care and the opportunity to integrate our clinical research practice with high quality IT infrastructure." Speaking at the inauguration, Sir William Castell said, "I am very pleased to be opening this new clinical research facility in Whitefield and commend Manipal AcuNova for its decision to build it. The center is a fine example of India's growing role in the global knowledge economy and is testament to the country's availability of high caliber science." "Manipal AcuNova is the only CRO to have an in-house expertise of 1,300 physicians of the Manipal network of hospitals as well as access to over 1.2 million patients per year. This gives Manipal AcuNova the extra edge to conduct innovative clinical research and provide speed to the pharmaceutical industry. Manipal AcuNova has seen impressive growth. It has conducted over 22 studies (phase II to IV) in varied therapeutic areas making it one of the leading players in Indian clinical research," said Dr Ramananda Nadig, chief operating officer, Manipal AcuNova. ]]> <![CDATA[AP]]> https://biospectrumindia.com/news/95/1589/ap.html https://biospectrumindia.com/news/95/1589/ap.html Thu, 09 Feb 2006 12:18:00 +0530 NEWS ANALYSIS NEWS ANALYSIS AP's stand on Bt cotton royalty will have far reaching impact The Andhra Pradesh government has moved the MRTPC against Mahyco-Monsanto Biotechnology Ltd contending that the seed company is charging abnormally high trait value of Rs 1,250 as royalty from the farmers for 450 gm of Bt cotton seed. On January 2, 2006 the Andhra Pradesh government moved the Monopolies and Restrictive Trade Practices Commission (MRTPC) against Mahyco-Monsanto Biotechnology Ltd (MMBL) on the "exorbitant" royalty being collected by it for Bt cotton. Besides MMBL, the state government has made Nuziveedu Seeds Ltd, Mahyco, Proagro Seed Company Ltd, Raasi Seeds Pvt Ltd as parties in the case. The Andhra Pradesh government noted that the farmers used to pay Rs 1,850 for a 450-gm packet of cottonseeds, of which Rs 1,250 is being paid to Monsanto as royalty. In the last three years, cotton farmers in Andhra Pradesh bought Bt cottonseeds worth Rs 130 crore of which Rs 78 crore went to Monsanto as royalty. Thus, the state observed that significant increase in cost of production virtually ate away the margin of farmers. The state government had blacklisted MMBL for selling Bt cottonseeds, as it has observed that the company has not agreed to pay compensation to the state cotton farmers who had suffered losses in the last four years due to crop failure. The case at MRTPC was scheduled to be heard on January 10, but was postponed to January 27. Yet again the hearing was postponed to February 27, sources said. The MRTPC's decision on the Andhra Pradesh case is likely to set a precedent. The government of Gujarat is considering approaching MRTPC against the seed company over exorbitant royalty. Gujarat is a state where the experts believe that unauthorized planting of unofficial variety of Bt cotton was sold for as low as Rs 450 a packet and nearly 60 per cent of the crop or about 50 lakh bales produced in 2005-06 season, represent use of unofficial or unapproved GM cottonseed. Many pleas to the governments from the industry failed to yield any positive results and to protect interests of the innovators of technology. Reacting to the government's move, Ranjana Smetacek, director, corporate affairs, Monsanto Holding Pvt Ltd said, "We believe that Bollgard is gaining increasing acceptance in all the cotton growing states, including Andhra Pradesh. Bollgard technology was introduced in Andhra Pradesh in 2002 through three Mahyco hybrids, and subsequent years saw the introduction of additional Bollgard cotton hybrids from Rasi Seeds, Ankur and Nuziveedu Seeds. The acres planted to Bollgard hybrid cottonseeds since 2002 increased from 10,000 to 700,000 acres in Andhra Pradesh and 72,682 to 3.1 million acres in the country. This large scale planting of hybrids with Bollgard technology is proof that the benefits are being derived from these seeds by farmers in the country in general and Andhra Pradesh in particular." Even an IMRB survey released in April 2005 found out that the net profit increase for Bollgard farmers was Rs 5,950 per acre or over 60 per cent over conventional cotton. Another key finding was the reduction of an average 4 to 5 pesticide sprays against bollworm, which translates into a saving of Rs 1,137 per acre. She observed that farmers recognize the value of Bollgard, which continues to gain acceptance among them in the nine states where it is being sold. The ever-increasing Bollgard plantings demonstrate that the Indian farmer is willing to adopt a technology that delivers consistent benefits in terms of reduced pesticide use and increased income. Farmers use this technology based on the agronomic need they face in their fields. In other words, each farmer has a choice and can determine if this technology will create value for them. Monsanto has licensed Bollgard technology to 21 different Indian cottonseed companies which have incorporated the trait into their best hybrid seeds. At present 20 Bollgard hybrids are being grown on approximately 3.1 million acres across India's nine cotton-growing states in 2005. This and the 150 percent growth of sale of Bt cottonseeds in 2004-05 show the acceptance of technology by the farming community across the country including Andra Pradesh. Regarding the high pricing, Ranjana Smetacek informed, "In the agriculture industry, the pricing philosophy is based on sharing the value that products and technology deliver to farmers. Factor such as replacement cost (cost of current agronomic methods and their effectiveness, benefits, and limitations), agronomic benefits (additional yield benefits, labour, equipment and fuel savings or application flexibility that a product or technology provides to farmers), and non-agronomic benefits (time savings, efficiency, risk-management, peace of mind, etc.) may used to determine price. Technology fees may be part of the price charged to farmers, and are used both to support current products in a market, and to fund research that will deliver new products. These fees are shared with the retail technology channel, seed partners, and Monsanto shareholders and cover the costs of doing business. Regarding compensation to the farmers, she said, "Monsanto is not directly involved in this compensation matter. Among the companies mentioned in the media report, only Mahyco has a compensation claim pending against it. Mahyco has got a stay order in court and are exploring their legal defenses. Reacting to the issue, the industry people who wished anonymity observed that it is a sorrowful situation and should be resolved at the earliest. The rigid stand of the Andhra Pradesh government will definitely have far reaching effect and in long term it will impact the seed industry. It will only affect the farmers who are actually reaping the benefits of the technology and not the government. The seed companies are investing a lot on R&D to develop new technologies to serve the farming community effectively. Steps have been taken to get the best result from the research activities so as to pass it on to the farming community. In an era of innovation and product patent, state and central governments have been funding projects on agri biotechnology. Even companies are investing on research activities with commercial values in mind. They wait for years to have the fruits and to share profits with the society. Government intervention at the time of commercialization might come in the way of investments in research and development in an era of new technologies. Yet the government has a role to play to put check on the monopoly and sale of spurious seeds so that the benefits would be shared by all. Narayan Kulkarni ]]> <![CDATA[Hasnain is Hyderabad varsity VC]]> https://biospectrumindia.com/news/95/4662/hasnain-is-hyderabad-varsity-vc.html https://biospectrumindia.com/news/95/4662/hasnain-is-hyderabad-varsity-vc.html Thu, 09 Feb 2006 12:16:00 +0530 Hasnain is Hyderabad varsity VC Hasnain is Hyderabad varsity VC Dr Seyed Ehtesham Hasnain, director of the Centre for DNA Fingerprinting and Diagnostics (CDFD), has become the new vice-chancellor of the University of Hyderabad. His selection for the post has been cleared by President APJ Abdul Kalam. Dr Hasnain is the first director of CDFD. He is the recipient of several national and international awards, including the prestigious GD Birla award for scientific research, Shanti Swarup Bhatnagar Prize, Golden Jubilee Biotechnology Fellowship Award and Ranbaxy Research Award. He succeeds Kota Harinarayana as vice-chancellor. Very recently, he has been conferred with the prestigious Padma Shri award. Dr Gowrishankar J will serve as the acting director of CDFD until a full time director is appointed. Malvinder Mohan Singh takes charge as CEO and MD, Ranbaxy Brian Tempest is chief mentor and executive vice chairman Dr Brian W Tempest as chief mentor and executive vice chairman of the Board As part of effective succession planning at the top level, the Board of Directors decided to promote with immediate effect, Dr Brian W Tempest as chief mentor and executive vice chairman of the Board. Simultaneously, Malvinder Mohan Singh, president Pharmaceuticals and executive director, succeeds Dr Brian Tempest as CEO and managing director of the company. Singh, while continuing to report to Dr Tempest, assumes complete operational responsibility for the company and will be focused on spearheading Ranbaxy's growth to its target of achieving $5 Billion of global sales by 2012. Drawing upon his long experience and in-depth knowledge of the pharmaceutical sector at the global level, Dr Tempest will play a key advisory role on strategic issues, and on enhancing Ranbaxy's global brand equity. Commenting on the announcement, Tejendra Khanna, chairman, Ranbaxy Laboratories Ltd, said, "With the changes now approved by the Board, I see the company combining insightful mentoring of a high order with strong operational leadership. This will give Ranbaxy, the extra edge to grow, innovate, consolidate and establish new benchmarks for performance at the global level." The Board of Ranbaxy Laboratories Ltd expressed strong optimism about the company's future and observed that it is poised for significant growth across global markets. Ranbaxy is well-positioned in the global marketplace to capitalize on its established competencies in R&D, rich product pipeline, global reach, assured product quality, management depth, speed-to-market operating style and strong corporate governance. Kiran Mazumdar-Shaw receives WIBTA 2006 award Kiran Mazumdar-Shaw, founder of Biocon India Kiran Mazumdar-Shaw, founder of Biocon India, received the Wharton - Infosys Business Transformation Awards (WIBTA) 2006 award, Asia Pacific in the Technology Change Agent category. The award is constituted by Infosys Technologies Ltd in association with Wharton School of the University of Pennsylvania. Speaking on the occasion, Kiran Mazumdar-Shaw who spearheaded Biocon's growth from a traditional enzymes manufacturer to fully integrated biopharmaceutical firm with major R&D initiatives said, "As Information Technology becomes a key driver of stakeholder value for an organization, it is operational excellence through continuous innovation that determines success. It is a pleasure to have our efforts in this direction be recognized internationally through an award as distinguished as WIBTA." The award was presented by NR Narayana Murthy, chairman of the Board and chief mentor, Infosys Technologies and Patrick Harker, dean of the Wharton School and Esther Dyson, the editor-at-large of CNET Networks. The awards, which are entering their fifth year, recognize visionaries and organizations that use technology in an innovative and creative manner to revolutionize their businesses. Speaking at the awards function, NR Narayana Murthy said, "Organizations should look beyond technological innovation as a means of delivering business impact to realize that innovation has the potential to transform a whole community. WIBTA is a tribute to the leaders, who envisioned and executed the transformation process propelling their organizations to new-found growth and impacting the society as a whole." Padma awards conferred A total of 106 Padma awards have been conferred this year. The awards are traditionally announced on the eve of the Republic Day. The award winners in the field of science and engineering include Dr Seyed Ehtesham Hasnain (Padma Shri), director, CDFD, Hyderabad; Prof Obaid Siddiqui (Padma Vibhushan) of the National Centre for Biological Sciences, Bangalore; Dr Madhav Gadgil (Padma Bhushan) of Agharkar Research Institute, Pune; Dr Swaminathan Sivaram (Padma Shri), director, National Chemical Laboratory, Pune; Dr Bonbehari Vishnu Nimbkar (Padma Shri) of Nimbkar Agricultural Research Institute, Phaltan and out of the five foreign nationals who have been conferred with the prestigious awards, renowned Mexican agricultural scientist Norman E Borlaug has been awarded Padma Vibhushan. Dr Seyed Ehtesham Hasnain Dr Seyed E Hasnain obtained his PhD from JNU (1980), New Delhi and worked briefly at the University of Delhi before leaving for a National Cancer Institute Post Doctoral Fellowship at the University of Alberta, Canada, where he was subsequently awarded the Alberta Heritage Foundation for Medical Research Fellow Award to work at the Department of Medicine. He then spent a couple of years at the Texas A & M University, USA and returned to India in 1987 to work as a staff scientist at the National Institute of Immunology (NII). Dr Hasnain, who was a visiting scientist at Oxford was appointed as the first director of CDFD in February 1999. He has recently been appointed Vice-Chancellor of University of Hyderabad. A member of the Science and Engineering Research Council (SERC) of the DST, he is the recipient of several national and international awards. Dr Hasnain has authored more than 160 original research papers and several book chapters. He has about a dozen patents filed in India and abroad. Dr Norman E Borlaug Dr Norman E Borlaug Dr Norman Ernest Borlaug joined the Rockefeller Foundation staff in Mexico in 1944 to increase the production and productivity of Mexican wheats. This Iowa native continued as director of the National Wheat Program in Mexico until the research center, Centro Internacional de Mejoramiento de maiz y Trigo (CIMMYT), was formed in 1965. He continued as director of Wheat Programs in CIMMYT until he retired in 1979. Dr Borlaug devoted his energies to improvement of wheat for more than 30 years. He contributed more than any other person to the "Green Revolution." Dr Borlaug serves on many boards and advises governments in the developing world on food production. Dr Borlaug's highest honor, the Nobel Prize for Peace, was awarded to him 1970. Prof Obaid Siddiqui Prof Obaid Siddiqui Prof. Obaid Siddiqi is the founder director of the TIFR National Centre for Biological Sciences at Bangalore. He began his research career in microbial genetics. He made contributions to the understanding of DNA transfer and recombination in fungi and bacteria. His experiments (with A. Garen) on the suppression of 'nonsense' mutation in E. Coli were an important step in the understanding of chain termination in polypeptide synthesis. In the seventies Prof. Siddiqi turned to behavioral genetics and neurobiology. His work (with S. Benzer) on paralytic mutations of Drosophila led to the identification of the genes that block nerve conduction and synaptic transmission. He and his associates have carried out pioneering experiments on neurogenetics of the chemical senses in Drosophila which have led to an improved understanding of how olfactory information is encoded in the brain of the fruit fly. Dr Madhav Gadgil Dr. Madhav Gadgil is one of the best and most prominent ecologists in Asia and arguably the most distinguished ecologist in India. Both his research and conservation interests successfully blend community ecology and human sociology as an unbroken continuum. He has had a profound effect on conservation in India, not only through his own work, but also by training many outstanding young ecologists. Originally a fish biologist when he went to Harvard for his PhD, Gadgil became interested in issues of life history evolution and the role of dispersal in population dynamics. He co-authored an influential book (M Gadgil and WH Bossert 1970, Life History Consequences of Natural Selection), and papers on selection of optimal life histories for plants, and on r and K theory. After returning to India, he established the Center for Ecological Sciences at the IISc. His membership in several Academies of Science, and his active participation in international organizations and committees on ecology and conservation, also document his international stature and recognition. Dr Swaminathan Sivaram Dr Swaminathan Sivaram is a polymer chemist of great distinction and is currently the director of the National Chemical Laboratory, Pune. Over the last 23 years, working as a research scientist and R&D Manager at IPCL and NCL, he has demonstrated how good science and technology work can be done in India. He has received several awards/honours including the prestigious Om Prakash Bhasin Award for Science & Technology (1995). The outstanding scientific achievements of Dr Sivaram have spanned a variety of areas in polymer science, namely synthesis, new and improved catalysts for polymerization, novel processes for monomers, and formulated products for scientific end applications. Dr Sivaram has established an active school of research in Ziegler Natta polymerization of olefins at NCL. His contribution to the area of polymer science and technology have had significant impacts on national development. ]]> <![CDATA[GlaxoSmithKline to introduce Boostrix]]> https://biospectrumindia.com/news/95/1344/glaxosmithkline-to-introduce-boostrix.html https://biospectrumindia.com/news/95/1344/glaxosmithkline-to-introduce-boostrix.html Thu, 09 Feb 2006 12:08:00 +0530 GlaxoSmithKline to introduce Boostrix Ace cricketer Kapil Dev with Kalyanasundaram, MD, GlaxoSmithKline and his little fans at the Boostrix stall. GlaxoSmithKline to introduce Boostrix GlaxoSmithKline has announced the forthcoming launch of the vaccine Boostrix comprising Acellular Pertussis reduced, Diphtheria Toxoid reduced and Tetanus Toxoid (dTpa) in India. Announcing this at the Pedicon 2006 conference at New Delhi, Kalayanasundaram, managing director, GlaxoSmithKline India, said, "Boostrix is available in 32 countries globally with 2 million doses already distributed since 1999 and will now be available in India for all age groups over 4 years. Clinical studies for Boostrix demonstrate a superior safety and immunogenicity profile in children and adolescents." Boostrix has been registered for use in children over the age of 4 years, who have already received their primary DTP doses in the first and second year of life. Currently Boostrix is the only globally approved acellular pertussis boosting vaccine for all age groups available in India. According to a Central Bureau of Health Intelligence (CBHI) study, the number of reported cases of pertussis in India has increased recently, by 50 percent from 1997 to 2003. Dr Sanjoy Datta, director of clinical R&D and medical affairs of GSK Biologicals - South Asia said, "Older children and adults have been proven to be reservoirs for pertussis disease, thus acting as a source of infection to the unprotected (i.e. those who are too young to be immunized or have never taken the vaccine or booster doses). Pertussis in newborns can be fatal." ... launches Suraksha Kavach Program GlaxoSmithKline has introduced the Suraksha Kavach Program that aims to create and cultivate the importance of protection and promote wellness in society. GlaxoSmithKline launched this unique social responsibility drive by participating and complementing the government's initiatives in recognizing the National Bravery Award winners. On the eve of India's 56th Republic Day, GlaxoSmithKline, in association with the Indian Council for Child Welfare (ICCW), held a special ceremony to honour the exemplary courage of the children who were selected for this year's National Bravery Award. The children were each presented a citation, a 'Suraksha Kavach' trophy and a pledge to protect them with GlaxoSmithKline vaccines. Speaking on the occasion, Dr Sanjoy K Datta, director - clinical R&D and medical affairs, GSK Biologicals - South Asia said, "We are extremely privileged to honour the achievements of these seventeen brave children. Their contribution is inspiring and their heroic deeds truly represent protection. They are ambassadors for the 'Suraksha Kavach' program, whose objective is to instill the importance of protection and wellness for individuals, families and society at large. Through these children, the program aims at creating, cultivating and rewarding the importance of protection in the society." Dr Cormac Kilty (extreme left) and Kiran Mazumdar-Shaw shake hands after signing the MoU. Bertie Ahern (center) looks on. Irish Bioindustry Association sign MoU with ABLE IBEC's Irish BioIndustry Association (IBIA) has signed a memorandum of understanding with its Indian equivalent, the Association of Biotechnology Led Enterprises (ABLE), in an effort to improve collaboration between the biotech sectors in Ireland and India. The agreement was signed at the headquarters of India's leading biotechnology company, Biocon in Bangalore. Dr Cormac Kilty, managing director of Dublin-based biotech company Biotrin and chair of the IBIA, signed on behalf of IBIA with Dr Kiran Mazumdar-Shaw, chairman and managing director of Biocon, Irish Honorary Council to India signing as President of ABLE. The signing was witnessed by Bertie Ahern Taoiseach and Minister for Enterprise, Trade and Employment, MicheÃ¡l Martin TD as was a key part of the ongoing Irish Trade Mission being led by the Taoiseach. This agreement, which is the first between the respective industries, lays the foundation for collaboration between the two fast growing sectors. Significantly, the agreement was signed soon after the news that the Indian biotech firms have posted combined revenues of over $1 billion for 2005, an increase of 36 percent on the previous year's figure. The new agreement is expected to open up potential partnerships in research and commercialization as well as sub-supply opportunities for Irish and Indian companies alike. Cormac Kilty, chairman, IBIA, said, "I am very exited about what is happening here in India. It bears many similarities to the Irish experience. We are both fast growing economies looking to be leaders in modern industries such as biotech. I believe that we have much to learn from each other. I have no doubt that very tangible benefits will flow out of this agreement." Kiran Mazumdar-Shaw, President - ABLE said, "My ties with Ireland go back several years and I am very pleased that ABLE and IBIA are coming together to synergise the biotech strengths of our respective countries. Biotechnology is a growing industry both in India and in Ireland and I am confident that with this agreement we have taken a step towards potential collaborations and knowledge sharing between our two countries." Matt Moran, director, IBEC, said, "India is strong in pharmaceuticals - just like Ireland. It is trying to develop biotech just like Ireland as well. It makes a huge amount of sense to partner together and help each other to take the lead. It is now our intention to work actively with our Indian counterparts to achieve this aim. I look forward to a very productive relationship." Ocimum ranks 55th in Deloitte Tech Fast 500 Asia-Pacific 2005 Ocimum Biosolutions, a Hyderabad-based life sciences R&D enabling company with competencies in BioIT, Microarrays and Contract Research Services, was ranked 55th amidst the 500 fastest growing technology companies of repute across the Asia-Pacific region by the world-renowned Deloitte Technology Fast 500 Asia-Pacific 2005 Program. The program recognizes public and private companies across the Asia Pacific regions that have achieved the fastest rates of annual revenue growth during the past three years. According to an official press release, Ocimum also has the distinction of scoring 4th rank in the Deloitte Technology Fast 50 India 2005 Award, again a program based on a three year average percentage revenue growth which ranks the 50 fastest growing technology companies by geographic region. This Fast 50 program supplements the broader Deloitte Technology Fast 500 initiative in that the winners typically become automatically eligible to participate in the Fast 500. The awards are researched and sponsored by the Deloitte Technology, Media & Telecommunications (TMT) Industry Group. Anuradha Acharya, CEO, Ocimum Biosolutions, said "We at Ocimum have just started on our growth track and this recognition by Deloitte is very encouraging for us as we look forward to attaining our desired results". Strand and ChemAxon enter into collaboration Strand Life Sciences, a premier in silico technologies innovation company focused on developing technologies for drug discovery and development has integrated ChemAxon's JChem suite of software with admetis, its tool for modeling and predicting drug-relevant properties of molecules in silico. The integrated offering will be launched in the early part of Q1 2006. admetis is a comprehensive tool for modeling and predicting drug-relevant properties of molecules in silico. It gives users the power to build custom models using their own data. This is made possible through easy and intuitive model-building workflows based on Strand's expertise in in silico model building. admetis comes packaged with its pre-built models, truPK and truTox, for predicting bioavailability, protein binding, volume distribution, elimination half life, rate of absorption and hERG binding. admetis has an extensive data mining and visualization module that supports an embedded chemical structure viewer. The inclusion of ChemAxon's JChem toolkit provides admetis with a feature rich, chemically aware data management and search framework. admetis users will be able to enjoy state of the art chemical editing and visualization capabilities as well as the power to build complex queries using structural and non structural data. Strides signs pact with Clinton Foundation for HIV drugs Strides Arcolab Ltd has signed an agreement with the Clinton Foundation to make available a range of affordable anti-retroviral drugs for the treatment of HIV/AIDS in countries that are under the aegis of the Clinton Foundation HIV/AIDS initiative. Speaking at a formal ceremony at New York to announce the agreement, Arun Kumar, Group CEO and managing director, Strides Arcolab Ltd, said "We are committed to supply a comprehensive range of first line and second line anti-retroviral drugs that meet global quality standards at affordable prices." Speaking on the occasion, Clinton said, "Strides Arcolab (India) will offer the ARV efavirenz for $240 per patient per year. This price represents savings of more than 30 percent from current market rates. Following this agreement, Strides will also supply first-line ARVs under Clinton Foundation agreements. Lowering the price of second-line drugs is a major priority for my Foundation in 2006. Treatment, once started, is a lifelong commitment, and over time patients move from low-price first-line drugs to second-line combinations that are at least 10 times more expensive. Keeping the global cost of AIDS treatment sustainable will only be possible if we lower the prices of these medicines." Mukesh D Ambani, chairman and managing director, Reliance Industries Ltd, delivering the keynote address at the first of the Dhirubhai Ambani Life Sciences Symposia Series on "Preventive and Predictive Molecular Diagnostics". KV Subramaniam, senior executive vice president, Reliance Life Sciences, Dr NK Ganguly, director general, ICMR and Dr Dhananjaya Saranath, research director, Reliance Life Sciences look on. "Future of molecular diagnostics is very bright and vastly stimulating" "The world is moving from looking disease as a state to disease as a process â€“ a process dependent on a person's genetic make-up, environment and life style. New methods of molecular diagnosis would help manage better a patient's disease. It would also help determine the pre-disposition of patients to diseases. Thus, the field of preventive and predictive molecular diagnostics promises to be very exciting. I have no doubt that the future of molecular diagnostics is very bright and vastly stimulating," said Mukesh Ambani, chairman and managing director, Reliance Industries Ltd. Delivering the keynote address at the first Dhirubhai Ambani Life Sciences Symposium on Preventive and Predictive Molecular Diagnostics that was inaugurated by Dr NK Ganguly, director general, Indian Council of Medical Research, Ambani said, "The predictive and preventive molecular diagnostics would bring about an era of personalized medicine. It would bring with it enormous opportunities for scientific, technological, business and social development. For the diagnostics industry this represents an unprecedented opportunity for integration, increased value and commercial opportunities. Research-led companies would have the opportunity to work on new targets based on nucleotide polymorphisms and biomarkers." Underlining the important complex issues that would come in the way of evolution of predictive and preventive molecular diagnostics in the larger realm of personalized medicine, he said, "Preventive and predictive molecular diagnostics would fundamentally change the way health care is delivered and managed. It would call for new partnerships â€“ among scientists, technologists, clinical research professionals, educationists, investors, businessmen, physicians, medical insurers, regulators and sociologists." He further said, "We at Reliance Life Sciences, believe we are lending a helping hand in the innovative, path breaking domain. It is a great chance to play a critical and lifesaving role in the realm of predictive medicine, a role that is unpredictable." "The Dhirubhai Ambani Life Sciences Symposia Series is an endeavor to bring state-of-knowledge, contemporary developments and future trends in diverse domains within life sciences, for the benefit of scientists, academicians, clinical professionals, and industry participants. This symposium would be followed by our second symposium on stem cells, slated for February 27-28, 2006. It will showcase developments in the world of stem cells, including that of Reliance Life Sciences since stem cells has been the first initiative of Reliance Life Sciences," said KV Subramaniam, senior executive vice president, Reliance Life Sciences Ltd. Asia's first life science portal launched Asia's first exclusive portal dedicated to the life sciences industry, www.biospectrumasia.com, which provides comprehensive coverage of the exciting business developments in the region, has been launched. "Through this portal, BioSpectrum, India's first and only exclusive biotechnology business magazine, will extend its footprint to cover the path breaking happenings in the Asia-Pacific region's life sciences," said Pradeep Gupta, chairman and managing director of CyberMedia (India) Ltd, the publisher of BioSpectrum. As the world's economic fulcrum gradually shifts towards Asia, there is an increased focus on the exciting happenings in different industrial sectors. In the 21st century, life sciences has emerged as one of the most promising segments in terms of growth as well as providing benefits to a vast number of people in the world. "In addition to the news-based website, the exciting developments in the life sciences sector in the world's fastest growing region will be delivered to industry leaders in all the Asia Pacific countries through a fortnightly digital magazine and a bi-monthly print magazine, under the brand name BioSpectrum from Singapore," added Shyam Malhotra, editor-in-chief, BioSpectrum. The Asia edition of BioSpectrum will provide comprehensive coverage and useful insights into the exciting areas of pharmaceuticals, biotechnology, medical devices, and research highlights and policy announcements from around the world, which will be of use to the life sciences business leaders in the region. Life sciences is the term used to refer to pharmaceuticals, biotechnology, medical devices and healthcare services. While Japan has always had a major presence in life sciences, including the world's second largest pharma industry, in recent years, China, India, Taiwan, Korea, Australia and Singapore have emerged as significant players in this arena. The global life sciences industry is estimated to be worth about $2 trillion. The Asia-Pacific region accounts for nearly 20 percent of the sector even though it is home to nearly 60 percent of the world's population. But this region is fast catching up with double-digit growth rates. If healthcare services are excluded, the life sciences sector will be approximately $1 trillion. And the Asia-Pacific region has nearly quarter of the share of life sciences excluding healthcare Transgene Biotek completes development of oral delivery of insulin Transgene Biotek Ltd has completed the development of oral delivery of insulin and oral delivery of Hepatitis B vaccine in collaboration with the pharmacology division headed by Dr Prakash V Diwan at the Indian Institute of Chemical Technology, Hyderabad. The pre-clinical trials on oral delivery of insulin and Hepatitis B have demonstrated exciting results. The drug is to be administered in liquid form as oral drops. Similarly, the pre-clinical trials on oral delivery of Hepatitis B vaccine have demonstrated the generation of anti-body titres to a single dose of oral delivery comparable to that of injectable Hepatitis B vaccine, according to information sent to BSE in December 2005. The information says that Transgene Biotek is the first company in the world to have developed this technology to deliver Hepatitis B vaccine through oral route. Oral administration of this vaccine that provides the easiness in administering the vaccine to the infants and children, combining with cost reduction shall be a major factor in the disease control of this viral infection across the world. With the pre-clinical trial data providing exciting results, the management is in discussions with one of the biggest pharma companies in the world to out-license the oral delivery of insulin as a first step and has also initiated steps to take it to the next stage of clinical trials in India and Europe simultaneously. Biocon Q3 net dips 28% Biocon Ltd reported a drop in net profit at Rs 44 crore for the third quarter ended December 31 against Rs 50 crore in the corresponding previous quarter. During the April-December period, earnings declined to Rs 126 crore from with Rs 155 crore a year ago, the company said in a statement. However, it added that Biocon's performance during the nine months was according to expectations with revenues touching Rs 578 crore. Consolidated sales grew 7 per cent over the same period in the previous year, while operating profits dropped by 7 per cent. The profit after tax margin stood at 22 per cent, it added. "The operating results continued to be challenged by difficult pricing environment in the European statins market. However, the US market for generic statins offered a respite in 2006-07," the statement said. Research services and insulin and other pharmaceutical products posted a strong growth during the nine-month period. Biocon's discovery-led diabetes and oncology research programmes were making good progress, the company said. Taking stock of the company's performance, Kiran Mazumdar-Shaw, chairman and managing director, said, "I am pleased that we continue to deliver healthy profits at a time when we are investing in our discovery-led research programs." "Operating margins of 30 per cent demonstrate the quality and spread of our various businesses," she said. "We are excited over the progress being made on the research and development fronts as we believe that we are creating powerful innovation platforms for future," she added. The company is building domain knowledge in both oncology and diabetes, which are focal points of its discovery-led research programs. The research, combined with manufacturing expertise, reinforced Biocon's integrated bio-pharmaceutical model, Mazumdar-Shaw said. Biocon gets GEAC nod to carry out clinical trials Biocon India Ltd has received green signal from the Genetic Engineering Approval Committee (GEAC) to conduct of clinical trials with r-Human Granulocyte Colony Stimulating Factor (rh GCSF) developed by it in India and scaleâ€“up of the product process for R&D purpose. Biocon proposes to conduct open, multicenter study, to evaluate efficacy and safety of rh GCSF in patients with chemotherapy induced neutropenia. The total number of patients to be enrolled is around 50. According to reports the company has identified 7 centers for conduct of clinical trials. Similarly Biocon has received the committee approval for conducting clinical trials with r-Streptokinase developed by it in India and scale-up of the product process for R&D purpose. The company proposes to conduct a randomized, comparative, multicenter study to evaluate efficacy and safety of r-Streptokinase in patients with acute myocardial infarcation. It is proposed to enroll about 60 patients at two centers namely department of Cardiology, St John's medical College hospital, Bangalore and Narayana Hrudayalaya Institute of Cardiac Sciences, Bangalore. The GEAC has also given its consent to Biocon to conduct large-scale process optimization studies (R& D purpose only) of oral insulin IN â€“105 precursor, for the production of oral formulation of recombinant human Insulin. News Flash Kapil Sibal elevated as cabinet minister In the first major expansion of his 20-month old Council of Ministers, Prime Minister Manmohan Singh on January 29, 2006 inducted 19 new ministers and elevated three Ministers of State to the Cabinet level. Kapil Sibal, who was the Minister of State Minister for Science & Technology and Ocean Development (independent charge), has now been promoted to the Cabinet rank to give due representation to the national capital Delhi in the Union Cabinet. The elevation of a suave and erudite Kapil Sibal as Cabinet Minister assumes significance considering the fact that the Prime Minister is keen to promote science and technology in the country. Sibal has been playing a very important role in promoting science and technology and his elevation will help in speeding up the growth of science and technology in the country. Sibal has been playing a key role in helping shape the future of biotechnology in the country. He initiated the debate on the National Biotech Policy and set the ball rolling with national biotech development framework. He has helped the industry by removing several hurdles, convinced the finance minister to grant concessions to the industry, and is now all set to introduce an India-specific Bayh-Dole like Act to spur innovations in research in academia. The industry is upbeat with Sibal's elevation as a Cabinet Minister. Elections for ABLE Executive Council in February The Association of Biotechnology Led Enterprises (ABLE) is holding the elections for its Executive Council on February 15. It has adopted for the first time an online election process. The nominations were filed from January 5, 2006 to January 31, 2006. These members of the Executive Council will then elect among themselves, the president, vice-president, general secretary and treasurer. The election is being conducted by the executive director of the society. Sultanate of Oman Licenses LabVantage's Sapphire LabVantage Solutions Pvt Ltd, a The Chatterjee Group Company, announced that the Sultanate of Oman has licensed its Sapphire Laboratory Information Management Solution (LIMS) for its regional environment and water resources laboratories. The Sultanate of Oman is one of the wealthiest countries per capita in the world, and as a fast growing nation is seeking to continuously improve the quality of its food, water, and other environmental resources. "We selected Sapphire for its cutting edge technology, out-of-the-box functionality, vast flexibility, and significant ease of use," stated Dr Subhash Deshmukh, head, Laboratory Operations of Ministry of Regional Municipality of the Sultanate of Oman. "We are honored to have the Sultanate of Oman as one of LabVantage's leading customers in the Middle East," said Anil Kastuar, president, LabVantage's Asia Pacific operations. "We look forwarded to working with them as we continue to expand our business in the region and in Asia." LabVantage will implement Sapphire across the Sultanate's environmental, food testing, microbiological, trace element analysis, and organic pollutants laboratories. With nine regional laboratories situated in different regions of Oman, the Sultanate will leverage Sapphire's thin-client technology for enterprise wide access and visibility. Moreover, LabVantage's Evergreen configuration tool will allow the Sultanate's users to tailor the same Sapphire solution to meet the unique needs of each of these laboratories while all running on one enterprise platform. ]]> <![CDATA[FABA helps India, Pakistan shake hands in biotech]]> https://biospectrumindia.com/news/95/2201/faba-helps-india-pakistan-shake-hands-in-biotech.html https://biospectrumindia.com/news/95/2201/faba-helps-india-pakistan-shake-hands-in-biotech.html Thu, 09 Feb 2006 12:03:00 +0530 Dr Anwar Nasim Dr Anwar Nasim, chairman, Pakistan's National Commission on Biotechnology, (extreme left), making a point at the FABA meeting in Lahore. FABA helps India, Pakistan shake hands in biotech It is not just cricket, Hindi movies and buses that are bringing India and Pakistan together in these days of increasing collaboration between the two countries. The biotech industries of both the countries too have jumped onto the "peace bandwagon" and have started to explore the potential partnerships among themselves. Things have moved quite fast in the last 12 months. A 10-member Indian biotech delegation, comprising CEOs, researchers and industry representatives, engaged their counterparts from Pakistan under the banner of the newly-floated Federation of Asian Biotech Association (FABA) in Lahore, Pakistan for three days. The Indian delegation was led by Dr BS Bajaj from the All India Biotech Association (AIBA), Hyderabad. The historic, 142-year-old Government College University (GCU), Lahore rolled out the red carpet to facilitate the biotech engagements between the two countries. The importance attached to the three-day meeting on "Business Opportunities in Industrial Biotechnology" was evident with the high-level of participation from the Pakistani side. The Governor of Punjab, Lt. Gen (Retd) Khalid Maqbool, the country's most powerful governor, took the lead to greet the Indian delegation. Dr Anwar Nasim, who is the biotech advisor to President General Musharraf and convenor ( life sciences) of the Pakistan's Higher Education Commission, was the prime mover behind the event and left no stone unturned to ensure that the Indian delegation could travel to Lahore without any visa hassles. The Governor of Punjab, Lt. Gen (Retd) Khalid Maqbool interacting with the delegates. Pakistan is keen to learn from India's biotech story. "It is going to be the century of biotechnology. All the biotech advancements, however, have been monopolized by the western nations because all the key high tech equipment required by biotechnologists have been developed by them," remarked Governor Maqbool. Stressing on the need for Pakistan to develop expertise in biotechnology, he said the country could continue to grow fruits for export. But that will not take the country very far. "The world fears China and India not because they produce top quality shirts, shoes and leather goods. They are feared for their technology developments," the governor, who is also the chancellor of GCU emphasized. "We have to produce a large talent pool of technologists in biotechnology, develop small and inexpensive diagnostic kits for diseases specific to the region, increase the efficiency of agricultural production processes. Universities need to open up to the industry," he said. Responding to the call for co-operation, Dr Bajaj said "Science has no boundaries. That is why we know that we can work together, shoulder to shoulder. FABA will work together with scientists to make biotech a great success story in the region." Biotech in Pakistan The government has declared biotechnology as a priority area for Pakistan in 2001 and a a National Commission on Biotechnology (NCB) was set up as an advisory body to the Ministry of Science and Technology to monitor the new developments in the field within the country and internationally. Pakistan has invested over Rs 100 crore in this sector so far. Most of the research work is done in 29 national research institutions under various ministries such as agriculture, science and technology, and atomic energy. There are many top class institutions comparable and even better than their counterparts in India. The country is producing hundreds of PhDs and MPhils in the biotech sector from these institutions, which are affiliated to different universities. A large number of scientists working in the US and other developed countries have also returned to boost the talent within Pakistan. The Vice Chancellor of GCU, Dr Khalid Aftab said there were many attractive schemes to retain the talented scientists who have returned from abroad. Many of them are paid US $5,000 (Rs 2,30,000) or more per month to tap their talents. GCU itself has started an Industrial Institute on Biotechnology to take up pilot scale manufacturing of biopharmaceuticals and build expertise in this area. The country's first brush with biotech started formally when the Pakistan Atomic Energy Commission set up the Nuclear Institute of Agricultural Biology (NIAB) in Faisalabad, organized training courses in recombinant DNA technologies. The Pakistan Council for Scientific and Industrial Research (PCSIR) and the Pakistan Agricultural Research Council had also started setting up various specialized research centers since 1971. The biotech industry is taking roots slowly. There are prominent companies like Qarshi Industries, Agri Biotech, MediPak, and institutions like the Pakistan Industrial Diagnostic Agricultural Network Agencies National Agencies, which are engaged in high quality biotech activities. FABA was launched formally nearly a year ago, on February 10, 2005 during the BioAsia conference in Hyderabad. The idea was mooted during the BioAsia 2004 conference. FABA was set up by eight member countries including India, Pakistan, Malaysia, Thailand, Singapore, Philippines and Sri Lanka. Israel, Iran and Saudi Arabia have since joined the association. Dr Nasim indicated that four more countries-Japan, Korea, Taiwan and Bangladesh - were expected to join the industry group this year. Indian Immunologicals CEO, KV Balasubramanian, gave an overview of the Indian industry's capabilities in the veterinary biotech products sector. The company has signed MoUs with agencies to distribute its range of animal vaccines in Pakistan. The regulatory approval is awaited. Iran grows world's first transgenic rice crop Scientists in Iran have made a global breakthrough by developing and commercializing the world's first transgenic rice crop. " In 2005, nearly 1,000 farmers have started to grow this rice crop, which has the Bt gene inserted to provide resistance to the highly damaging stem borer insect," FABA's Iranian chapter convenor Mohammed H Sanati told the gathering. Dr Sanati is also a molecular geneticist at Iran's National Research Center for Genetic Engineering and Biotechnology, Teheran. When the crop is fully commercialized in 2006, it is expected to be grown in about 50,000 acres. The crop was developed by Iranian scientists with the assistance of the International Rice Research Institute (IRRI), Manila, Philippines. IRRI is part of a global network of publicly funded agriculture research institution, called CGIAR. Chinese scientists are also close to developing a transgenic rice variety. Dr Sanati said extensive trials to ensure safety of the transgenic rice variety was done in the country before it was approved for large scale commercial cultivation. Studies have indicated that the Bt rice showed 10 percent increase in yields to reap 2.2 tons per acre. He revealed that Iran was close to developing a transgenic sugar beet crop. Iranian scientists have also developed Bioflash, a slow releasing floating form of Bt granules, which can be used extensively in the control of malaria. The first formal contacts between the countries started in 2004 and in May 2005, a high level delegation of agricultural scientists had visited Lahore from India to break the ice. The January meeting has taken it to the next level with the involvement of industry leaders from both the sides. A lot more activities involving industry leaders from both countries are expected to take place in Hyderabad during BioAsia 2006 and the BioPartnering conference being organized by FABA in March in Pakistan. Biotech indeed is moving forward in the right direction in sharing and building expertise in the region. Naryanan Suresh in Lahore, Pakistan ]]> <![CDATA[Funding for biotech up in 2005]]> https://biospectrumindia.com/news/95/2508/funding-for-biotech-up-in-2005.html https://biospectrumindia.com/news/95/2508/funding-for-biotech-up-in-2005.html Thu, 09 Feb 2006 11:48:00 +0530 Funding for biotech up in 2005 Funding for biotech up in 2005 The global biotechnology industry has attracted large investments in the last few years with a 12 percent increase in 2005. A study by Irving Levin Associates, a research firm based in Norwalk, Connecticut, has revealed that venture capitalists increasingly placed their bets on healthcare and biotech during 2005. The number of dollars was up five percent from 2004 to $7.3 billion, and there were a larger number of deals. The study noted that the biopharmaceutical sector scored $2.1 billion, based on 102 deals with disclosed prices. The medical device sector and the traditional pharmaceutical sector each accounted for approximately $1.4 billion in venture capital, although there were more deals in medical devices than pharma. "Corporate investors made up some of the VC funding in healthcare during 2005. The IPO market may be lackluster, but big pharma is hungry for novel, proprietary therapies," said Stephen M Monroe, senior editor, Irving Levin Associates. Despite the increase in deals, the median investment size was slightly smaller. For the year ended December 31, the median investment size was $11.3 million, down from $12 million during 2004. However, the median investment size increased by nearly 19 percent during 2005, compared with 2003. According to the report from Irving Levin Associates, the top players in healthcare VC are also shifting. MPM Capital led the top 10 venture firms by number of investments during 2005, having participated in 17 investments, followed by Alta Partners, Domain Associates and HealthCap, each with 15 investments, according to the report from Irving Levin Associates. The total financing in the biotech industry, according to Bio World, in the last few years has been on the rise after it dropped to $10.5 billion in 2002 from a high of $38 billion in 2000. After this slump, again the industry has been in the eye of investors and they are making investments into the industry. The industry saw a total financing of $16.9 billion in 2003 and $20.8 billion in 2004. "Although biotech started out 2005 on a slow note, it has seen positive increases since April. But, large cap companies with robust product pipelines and diversity have led biotech's success in the capital markets. By any performance measures, 2005 was an exceptional year for the biotech industry in terms of financings and partnering, bringing in a record $35 billion for the US companies," noted G Steven Burrill, CEO of Burrill & Company, a San Francisco-based global leader in life sciences with principal activities in venture capital, merchant banking and media. The amount of venture capital generated by biotechs was up a modest eight percent compared to the Q3 2005 amount raised. Again, like the previous quarter there were plenty of deals that got done - 47 in fact, averaging about $20 million per investment (same as Q3 05). Year-over-date, the venture capital raised $3.5 billion in 2005 that was slightly on lower side of $3.7 billion generated in 2004. There was a gradual increase in the flow of investments into the industry each quarter in 2005 except the Q1 over the corresponding period the previous year. Notwithstanding what has been a very challenging year economically and a very tough equity market, $17.3 billion was invested in the biotech sector in 2005 with all forms of funding finding takers and $17 billion in partnering capital in 2005. US-based biotech funds raised approximately $7 billion in 2005 (up from $5 billion in 2004) and life science investments by the venture capital community have increased from 2004. Private Investments in Public Entities (PIPEs) and Secondaries remained flat while IPOs and debt financing fell short of the comparable 2004 totals. Public financings overall also remained flat. The increase in the growth of biotech internationally continued to take place in 2005 with China and India emerging with the potential to become biotech "powerhouses" in the next five to ten years. The prediction for 2006 Biotechnology will continue to fuel a major transformation in healthcare - one that emphasizes earlier disease detection, more targeted treatments, and adjunctive support through enhanced nutrition. According to Burrill's predictions for biotech in 2006, the industry will raise over $35 billion in 2006, with approximately $25 billion from the public equity markets capital and $10 billion in partnering. A reasonably robust public equity IPO market - 30+ in the US in 2006 and even a larger number internationally. Even the members of the National Venture Capital Association (NVCA) that represents over 400 venture capital and private equity firms in US, expressed their optimism on life sciences industry. Patrick Ennis, managing director, ARCH Venture Partners observed, "In 2006 we will see increased activity in funding interdisciplinary start-ups as markets converge and customers demand innovative products. One area in particular is the interface between Life Sciences and Information Technology. Advances in computing, materials science and nanotechnology are enabling life changing breakthroughs in the healthcare industry". Sharing similar views Deepak Kamra, general partner, Canaan Partners noted, "In 2006, the rewards will come for the more adventurous venture firms. Silicon Valley and the US markets still have good opportunities but do not promise the kind of excitement and rapid market expansion that India, China, Europe and Israel do. The US venture industry will accelerate its advance towards worldwide penetration for it to get better returns. Bangalore and Shanghai beckon with lots of risk but higher returns." EMEA issues guidelines for registering biosimilars The European Medicines Agency (EMEA), a decentralized body of the European Union headquartered in London, has adopted guidelines on similar biological medicinal products. The EMEA felt the need to issue guidance on this emerging issue as the applicants of similar biological medicinal products, who have applied for scientific advice from the Committee for Medicinal Products for Human Use (CHMP), expressed the need for specific guidance. The advances as well as the limitations of methods and techniques available today for the full characterization of such medicinal products have already prompted the CHMP to initiate a number of specific guidelines relevant to quality, non-clinical and clinical issues, to be addressed within the development programs of similar biological medicinal products. The CHMP issues specific guidelines concerning the scientific data to be provided to substantiate the claim of similarity used as the basis for a Marketing Authorization Application (MAA) for any biological medicinal product (see Section 3.2.1.1, Part I, Annex I to Directive 2001/83/EC), eg: medicinal products containing biotechnology derived proteins as active substance, immunologicals such as vaccines, blood-derived products and monoclonal antibodies. The CHMP guidelines addressing the planning and conduct of comparability studies should always be read in conjunction with relevant legislative and administrative provisions in force in the EU. The guidelines will help to introduce the concept of similar biological medicinal products, outline the basic principles to be applied and will provide applicants with a 'user guide', showing where to find relevant scientific information in the various CHMP guidelines, in order to substantiate the claim of similarity. The CHMP has or may develop additional guidance documents addressing both the quality, non-clinical and clinical aspects for the development of similar biological medicinal products. Product-class specific guidance documents on pre-clinical and clinical studies to be conducted for the development of defined similar biological medicinal products will be made progressively available. It should be noted that the scientific principles described in quality and non-clinical/clinical guidelines applicable to similar biological medicinal products containing biotechnology-derived proteins, as active substance may also be useful when considering non biotechnology-derived biological medicinal products. Guidelines applicable to all similar biological medicinal products While developing a similar biological medicinal product and carrying out the comparability exercise to demonstrate that this product is similar to another one already authorized in the EU, some existing CHMP guidelines may be relevant and should therefore be taken into account. For example: CPMP/BWP/328/99 Development Pharmaceutics for Biotechnological and Biological Products - Annex to Note for Guidance on Development Pharmaceutics (CPMP/QWP/155/96) Topic Q5C, Step 4 Note for Guidance on Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological Products (CPMP/ICH/138/95 - adopted Dec. 95) Topic Q6B, Step 4 Note For Guidance on Specifications: Test Procedures and Acceptance Criteria for Biotechnological/Biological Products (CPMP/ICH/365/96 - Adopted March 99) ICH Topic S6, Step 4 Note for Preclinical Safety Evaluation of Biotechnology-Derived Products (CPMP/ICH/302/95 - adopted Sept. 97) Biological Products containing Biotechnology-Derived Proteins as active substance In addition to this guideline, the CHMP is developing further guidelines on Similar Biological Medicinal Products (see CHMP monthly report, May 2005), eg: Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substances: Quality issues (EMEA/CHMP/BWP/49348/2005). Guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues (EMEA/CHMP/42832/2005). Annex guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues-guidance on biosimilar medicinal products containing recombinant human insulin (EMEA/CHMP/32775/2005). Annex guideline on similar biological medicinal products containing biotechnology-derived proteins as active substance: non-clinical and clinical issues-guidance on biosimilar medicinal products containing somatropin (EMEA/CHMP/94528/2005). Additional product-class specific annexes are envisaged to provide guidance for products containing rG-CSF and epoetin and others as the need arises and will be made available in the EMEA website. The current guidelines, relevant to comparability and similar biological medicinal products will be complemented by the above guidelines for aspects concerning similar biological medicinal products. In addition, the quality guideline (CPMP/BWP/3207/00) will be replaced by ICH Q5E for aspects concerning quality changes to the manufacturing processes of biotechnological/biological products by: The "Guideline on comparability of medicinal products containing biotechnology-derived proteins as active substance â€“ Quality issues (CPMP/BWP/3207/00)". The "Guideline on comparability of medicinal products containing biotechnology-derived proteins as active substance - Non-clinical and clinical issues (CPMP/Ad-Hoc group on (non)-clinical comparability of biotechnology products/3097/02)". Immunologicals such as vaccines and allergens Vaccines are complex biological medicinal products. Currently, it seems unlikely that these products may be thoroughly characterized at a molecular level. Consequently, vaccines have to be considered on a case-by-case basis. Applicants should take appropriate advice from the EU Regulatory Authorities. Allergen products are similarly complex and the same approach should be taken. In addition to the CHMP guidelines applicable to all biological medicinal products, the following guidelines should be taken into consideration: The CHMP guidelines addressing the quality, non-clinical and clinical aspects of immunological such as vaccines are as follows: CPMP/BWP/477/97 Note for guidance on Pharmaceutical and Biological Aspects of Combined Vaccines, (CPMP adopted July 1998). CPMP/BWP/2490/00 Note for Guidance on Cell Culture Inactivated Influenza Vaccines (Adopted by CPMP January 2002) - Annex to Note for Guidance on Harmonisation of requirements for Influenza Vaccines CPMP/BWP/214/96 CPMP/BWP/214/96 Note for Guidance on Harmonisation of Requirements for Influenza Vaccines (CPMP adopted March 97) CPMP/BWP/2289/01 Points to Consider on the Development of Live Attenuated Influenza Vaccines (CPMP Adopted, February 2003) CPMP/BWP/243/96 Note for Guidance on Allergen Products (CPMP adopted March.96) CPMP/EWP/463/97 Note for guidance on Clinical Evaluation of New Vaccines (CPMP adopted 19 May 1999) Blood or plasma-derived products and their recombinant alternatives The BWP and BPWG guidelines listed below should be taken into consideration, in addition to the applicable CHMP guidelines (Section 3.1 and 3.2). In view of the complex and variable physico-chemical, biological and functional characteristics of the products listed in the BPWG guidelines mentioned below, it will not be acceptable to submit a reduced clinical dossier when claiming similarity to a reference medicinal product. As a result, applications for such similar products will still need to satisfy the safety and efficacy requirements described in these BPWG guidelines for "new products". For quality issues: CPMP/BWP/269/95 Rev.3 Note for guidance on Plasma -Derived Medicinal Products (CPMP adopted Jan. 2001). For non-clinical and clinical considerations: CPMP/BPWG/283/00 Note for Guidance on the Clinical Investigation of Human Normal Immunoglobulin for Subcutaneous and Intramuscular use (Adopted July 2002) CPMP/BPWG/2220/99 Note for Guidance on the Clinical Investigation of Plasma derived Antithrombin Products (Adopted January 2002) CPMP/BPWG/198/95 Rev. 1 Note for Guidance on the Clinical Investigation of Human Plasma Derived Factor VIII and IX Products (Adopted October 2000) CPMP/BPWG/1561/99 Note for Guidance on the Clinical Investigation of Recombinant Factor VIII and IX Products (Adopted October 2000) CPMP/BPWG/388/95 Rev. 1 Note for Guidance on the Clinical Investigation of Human Normal Immunoglobulin for Intravenous Administration (IVIg) (Adopted June 2000) CPMP/BPWG/575/99 Note for Guidance on the Clinical Investigation of Human Anti-D Immunoglobulin for Intravenous and/or Intramuscular Use (Adopted June 2000) Other biological medicinal products Other types of biological medicinal products exist such as gene or cell therapy medicinal products. These products are of a complex nature and will be considered in the future in light of the scientific knowledge and regulatory experience gained at the time. In any case, companies developing similar biological medicinal products are invited to contact the Agency to obtain further advice on their development. The details of the CHMP guidelines are available at following links of the EMEA: Website: www.emea.eu.int/index/indexh1.htm www.emea.eu.int/htms/human/bwp/bwpfin.htm www.emea.eu.int/htms/human/bwp/bwpdraft.htm www.emea.eu.int/htms/human/bpwg/bpwgfin.htm www.emea.eu.int/htms/human/bpwg/bpwgdraft.htm Biotech industry ends 2005 with breakthrough product approvals The biotechnology industry ended 2005 with steady financial investments and product deliveries as companies succeeded in introducing novel therapies for patients suffering from some of the most devastating and deadly diseases. The year also marked significant advancements in agricultural and environmental biotechnology. "The biotech industry has reached a maturity level capable of producing a steady stream of new and unique therapies. The goal is to produce even more targeted therapies that will result in more effective medicines," said Jim Greenwood, president and CEO of the Biotechnology Industry Organization (BIO). The Food and Drug Administration (FDA) in 2005 approved seven recombinant biologics, as well as a number of first-in-class products and several "orphan drugs" â€“ or products that treat a rare disease affecting fewer than 200,000 Americans. About 45 percent of all recombinant and monoclonal antibodies cleared for marketing have been approved since 2000, demonstrating a very recent growing trend of industry market success. Running slightly behind 2004, biotech companies last year raised about $20.1 billion in public and private financing, compared to $20.8 billion the previous year. Financings in 2004 and 2005 top all annual figures from the previous decade with the exception of the year 2000, when the industry raised a record $38 billion following completion of the draft sequence of the human genome. Source: www.bio.org ]]> <![CDATA[Early mover advantage]]> https://biospectrumindia.com/news/95/1691/early-mover-advantage.html https://biospectrumindia.com/news/95/1691/early-mover-advantage.html Thu, 09 Feb 2006 11:44:00 +0530 TAMIFLU TAMIFLU Early mover advantage The big pharma companies tried hard to get the sub license for manufacturing Oseltamivir (generic "Tamiflu") from Roche. At the end, Hetero Drugs grabbed the bite beating the competition. Its early initiatives well ahead of others served it with the results. The battle between the leading pharmaceutical companies of India to get the sub license for manufacturing Oseltamivir (generic "Tamiflu") ended on December 21, 2005 as Swiss pharmaceutical company Roche has granted Hetero Drugs Ltd, a sub-license for the production and marketing of Oseltamivir. Under the sub-licensing agreement, Roche authorizes Hetero to manufacture and market both the active pharmaceutical ingredient (API) and finished product of Oseltamivir for supply to India, least developed countries and developing countries. This agreement focused on providing Oseltamivir for government pandemic use and will have an immediate effect on the availability in India and developing countries â€“ both directly and through further agreements with local companies. Need for licensing Responding to the heightened demand for Tamiflu and death of nine persons due to avian influenza (including two in China, four in Turkey and three in Indonesia as on January 30, 2006 and 85 deaths since 2003 in countries like Cambodia, China, Indonesia, Thailand, Turkey and Vietnam), Roche's priority is to ensure Tamiflu will be available for seasonal use to patients and to fulfil government pandemic orders. In 2006 Roche has donated another two million treatment courses of Tamiflu to the WHO. This is in addition to previous donations made by Roche in 2004 and 2005, and results in a total of 5.125 million treatment courses being available to the WHO to help people affected by a potential pandemic. Roche will have increased its own production capacity by the end of 2006. It will then be in a position to potentially produce 300 million treatments of Tamiflu annually. The expansion will be achieved by a further stepwise scale-up of Roche's production network. It means a ten-fold increase over the capacity in 2004. But to meet the present growing need it has decided to work to expand collaborative production network. In less than two months it has completed the evaluation of around 200 third parties interested in getting involved in the manufacturing of Tamiflu. After systematic screening, Roche production experts zeroed on to twelve companies globally that meet the defined criteria in terms of quality, technical ability, capacity and the speed of bringing that capacity on stream. These companies include major pharmaceutical companies, large generic manufacturers and specialty chemical producers. It has so far signed agreements with only two companies - one with Hetero Drugs Ltd from India and second with Shanghai Pharmaceutical Group, a Chinese company, the first to sign sub-licensing agreement with Roche for the overall production of Oseltamivir for pandemic use in China. Roche believes that it is not the patent that is the concern but the production capacities. Roche says the manufacturing of Tamiflu is complex and involves 10 main steps, some of which have been identified as complicated (e.g. azide chemistry). Manufacturing takes approximately 6-8 months once all the raw materials have been sourced. However, Roche's assumption is that for any party starting from scratch it would take 2 to 3 years to produce Tamiflu. The present status â€¢ China: Roche and Shanghai Pharmaceutical Group have signed the first sub-licensing agreement for the overall production of Oseltamivir for pandemic use in China. â€¢ Taiwan: Roche will be in a position to deliver requested quantities during 2006. â€¢ Vietnam: Roche will be providing capsules or active pharmaceutical ingredient for third parties to encapsulate locally. â€¢ Korea and Malaysia: Roche is providing capsules. â€¢ India: Roche has granted a sub-license to India's Hetero Drugs to make Oseltamivir for India and developing countries. In some countries, e.g. Thailand, Philippines and Indonesia, Tamiflu is not patent protected. These governments are therefore free to purchase or manufacture Oseltamivir at their discretion. Roche remains willing to discuss supplying governments orders and the quality requirements of supply.   Whilst Roche says it remains on schedule to meet the current orders received from over 50 governments, the collaboration with Hetero will enhance the supply of Oseltamivir in some of the world's poorest countries, resulting in earlier than anticipated delivery timelines and more capacity for further orders. Hetero is the first company that was identified to be able to speed up agreed delivery timelines in the first half of 2006. "As a result of a period of intense production planning, we are pleased to announce the partnership with Hetero Drugs as the latest step in our scale-up efforts to meet the needs of governments in preparing for the potential public health threat posed by avian influenza. This is another demonstration of Roche's commitment to working as a collaborative and responsible partner with governments and the World Health Organization (WHO) to assist in pandemic planning, " said David Reddy, Roche's Pandemic Taskforce Leader on signing of agreement between Roche and Hetero Drugs. Dr B Parthasaradhi Reddy, chairman and managing director, Hetero Group of Companies said, "Hetero commends Roche's commitment to increasing the availability of Tamiflu for government pandemic stockpiling. Hetero is capable of fulfilling Roche's objective of addressing the needs of least developed and developing countries in preparing for a pandemic by increasing supplies of Oseltamivir. " The winner Hetero Drugs Ltd, the Rs 720-crore pharmaceutical group company based in Hyderabad, is a relatively young company started in 1993. It maintained a low profile during the entire episode but it still bagged the license. It has beaten Indian pharma giants such as Ranbaxy Laboratories Ltd, which has recorded consolidated sales of Rs 5195.60 crore ($1178 million for December ending 2005) and Cipla that has garnered a 5.5 percent share of the domestic market at the retail level, with sales of Rs 1,128 crore (as on March 31, 2005 and marginally ahead of GlaxoSmithKline). Both these were trying hard to get the license from Roche. At the end it was Hetero Drugs that went with the order. On December1, 2005, Ranbaxy Laboratories Ltd said that if called upon by the US Government or by the innovator Roche, the Ranbaxy global organization is well prepared to provide oseltamivir phosphate capsules (generic version of Tamiflu) to the US healthcare system to meet the threat of the avian flu that has now become a global concern. Dr Brian Tempest, then CEO and Managing Director and now the chief mentor of Ranbaxy stated, "In terms of available capacity, within six months, we anticipate being able to produce 22 Tons per Annum (TPA) of the Active Pharmaceutical Ingredient (API) based on Ranbaxy's API process. Within a twelve-month period, we expect to scale up our operations to produce a total of 100 TPA. The 22TPA translates to a total of approximately 300 million 75mg capsules, and within a year to a total of 1.3 billion 75 mg capsules. The API would be manufactured in Ranbaxy's FDA compliant facilities in India, and the capsules could be manufactured at its US facilities. It is estimated that within the first six months approximately 20 million patients could receive a course of treatment, and within the first year in excess of 100 Million patients could be managed for the avian flu." Ranbaxy also stated that it would make all efforts to secure the required quantities, the starting material (shikimic acid) that is critical to the entire process from a variety of independent sources. And it will also make all efforts to work with the USFDA to secure approvals to manufacture the API as well as capsules within Ranbaxy facilities in order to reach the projected goals as may be indicated by the US government. "We are prepared and are committed to meet the needs of the US healthcare system, and are able and willing to partner with other organizations, including the innovator, to effectively meet this public health challenge that threatens the US," said Dr Tempest. Similarly Cipla too had said that it could manufacture 100,000-200,000 dosages of the bird flu drug Tamiflu for emergencies. However, Roche went with Hetero Drugs which has been working on this project for over two and half years. Following approval from the Government of India to manufacture and market a generic version of Oseltamivir, Hetero began investing in the manufacturing of Oseltamivir. Hetero has invested about Rs 76.5 crore on this project. The reports say it had bagged the order given the fact its focus on retroviral products from 1996. Earlier, Generic Product Organisation Thailand had approved for providing necessary inputs for Tamiflu. Since then it was engaged in work related to this project over the last couple of years. Hetero maintained that it is currently the only company, which is in the advanced stages of the production process for a generic version of Oseltamivir. Hetero with its huge capacities, can fulfil the total requirement of the Indian market. It is committed to deliver one million capsules of Oseltamivir to the Government of India by January 2006. Besides it will start fulfilling orders for least developed and developing countries. Each capsule is likely to be priced at $12. This has the potential to add Rs 100 crore to its turnover in the first year of marketing. A release from Hetero adds, "This is the first instance in which a sublicense has been granted since the introduction of India's new patent legislation agreed in 2005. This legislation complies with international patent laws. Roche and Gilead Sciences filed patents for Oseltamivir in India of which some have been granted and the remaining process and product patents are currently under evaluation by the patent office in India." Reacting to this, a spokesperson of Ranbaxy said, "Ranbaxy has always demonstrated commitment to support humanitarian efforts by making available quality affordable generic products around the world employing all necessary critical resources. The company is confident of its scientific know-how to produce generic Oseltamivir, the Active Pharmaceutical Ingredient, in large volumes. The company has the capacity to supply Oseltamivir to markets around the world after meeting the required issues relating to Intellectual Property and other regulatory clearances and we are preparing ourselves to begin commercial production. Ranbaxy will be very happy to be a part of the government effort in any part of the world to combat avian-flu."   Narayan Kulkarni   ]]> <![CDATA[Moving in the right path, but still a long way to go]]> https://biospectrumindia.com/news/95/5401/moving-in-the-right-path-but-still-a-long-way-to-go.html https://biospectrumindia.com/news/95/5401/moving-in-the-right-path-but-still-a-long-way-to-go.html Thu, 09 Feb 2006 11:40:00 +0530 PATENT REGIME PATENT REGIME Moving in the right path, but still a long way to go On January 1, 2005 India brought in an amendment to the Patent Act to comply with the World Trade Organization rules. But nothing much seems to have changed since then. However, this has brought some level of confidence among the multinationals looking at India for partnerships/ tie-ups. But still a lot needs to done and it will take time for things to move in the right direction. On April 28, 2005 the Thomson Scientific unit of the Thomson Corporation announced that Derwent World Patents Index (DWPI) will now include Indian patents, both pre-grant applications and granted patents. The inclusion of Indian patents in DWPI, the world's most comprehensive database of value-added patent documents which currently contains details of over 28 million patent documents in 13.5 million unique invention records, follows the culmination of the government's long process of amending India's national patent laws to ensure they conform to Trade Related Intellectual Property Rights (TRIPS) norms. "Following the recent legislative changes, the number of patent filings is forecast to jump from current annual levels of about 10,000 per year to over 25,000 annually, with a corresponding increase in patent litigation. Since India has now become a major player in the IP arena, we recognized the importance of giving our users comprehensive and quick access to Indian patents," said Brian Tyler, executive vice president of corporate markets, Thomson Scientific. The inclusion of patents granted in India is also significant for DWPI because it is expected that Indian patent activity will increase dramatically, particularly in the fields of pharmaceuticals, biotechnology and information technology. In the past, India only permitted patents for processes and not products. With new amendments to the Patent Act, it is now possible to obtain product patents in pharmaceuticals and agrochemicals, telecom and software industries. The total R&D expenditure in India has also considerably increased, leading to new drug development projects and the creation of facilities essential for the development of new drugs. In addition to this, the Swiss pharmaceutical company Roche has finally ended the high drama on December 21, 2005 by granting Hetero Drugs, a Hyderabad-based pharmaceutical company, a sub-license for the production and marketing of Oseltamivir (generic "Tamiflu"). This is the first instance in which a sublicense has been granted since the introduction of India's new patent legislation in 2005. This legislation complies with international patent laws. Roche and Gilead Sciences filed patents for Oseltamivir in India of which some have been granted and the remaining process and product patents are currently under evaluation by the patent office in India. These two instances will give an idea about having the Product Patent Act. India recognized product patents for food products, pharmaceuticals and agro-chemicals starting calendar year 2005 and is applicable to all these products patented after 1995. Sharing his experience, Mohanbir Sawhney, the well-known technology and e- commerce guru, said, "the Indian software and business process outsourcing companies need to change course. From merely offering software and IT â€“enabled services, it is time to think KEPS â€“ knowledge enabled products and services." This is true not only for the Indian software industry - a leading export earner for the country - but also for the Indian life sciences, pharmaceutical and biotechnology industries which are growing rapidly and attracting the attention of the world's leading pharma and biotechnology companies. This is just because of the India's entry into the product patent regime in January 2005. At present these companies are actually into the contract research and manufacturing or in licensing agreement with the multinationals for marketing their products in India, offering services in the form of clinical research and clinical data management. Yes this will help earn profits but in the long run, they will lose their margins to others by paying royalty (take the case of Monsanto's Bollgard technology where it is receiving a good amount of royalty from companies like Mahyco, Nuziveed, Rasi and Ankur Seeds). So to keep pace with the changing global scenario, Indian companies may have to look at innovation. Otherwise they will end up making marginal profits. Now that it is a little over a year since India entered the IPR regime, it is time to look back and review how the pharma scenario has changed. "Many pharma multinationals have now started looking at the Indian market with a renewed interest, albeit with a cautious approach watching the progress of IPR implementation in letter and spirit. There is a spurt in capitalizing on outsourcing opportunities as the global pharma companies are under pressure to contain the costs," observed Dr Ajit Dangi, director general, Organization of Pharmaceutical Producers of India, Mumbai. Sharing similar views, Nitin Deshmukh, head â€“ private equity, Kotak Mahindra Bank Ltd and director, Association of Biotechnology Led Enterprises, said, "The Patent Amendment Act 2005 has changed the perception about India. The multinational companies are now looking at India and pretty much open for discussing with the local companies. This has given a boost to many local companies who have been certainly going up the value chain." Rajesh Jain, joint managing director, Panacea Biotec, New Delhi, echoed similar views. He said, "Although one year is too short to make an assessment of the impact of product-patent regime, the failure to obtain "new use patent" on pre-existing drugs as per approved product-patent regime of the country, has changed the mindset in Indian industries to develop new drugs, vaccines and diagnostics. Thus, a few major biotech/pharma companies have geared up to develop novel therapeutic requiring R&D, along with producing generic and biogeneric drugs that could be marketed internationally. In fact, companies that thrived on alternate production-methods by taking advantage of erstwhile process patent regime have been forced to reconsider their long-term strategies." He continued, "The product-patent regime is gradually changing the mindset of the Indian biotech industry for "discovering new drugs" by exploiting its vast biodiversity and largely unexplored biological resources. The investments in R&D are certainly going to be the 'key factor' in the coming year to help Indian pharma/biotech industry become globally competitive. Although producing generics and biogenerics or bio-similars of patented expired drugs make a good business sense, this will be a short-term business module. Better and efficacious drugs that have been developed as result of the intensive science based discovery would in long run be a keystone for the biotech and pharma industry. However, fears exist in the biotech industries in their ability to protect Indian product-patent in other countries. To fight a legal battle against industry giants in rich nations would be an uphill task for an Indian pharmaceutical firm. Although Indian industries has not faced this situation as yet, much thought needs to given in this area, specifically role of the government of India in protecting the Indian product patent rights." "This has not affected Panacea Biotec as we did not adopt alternate production method route in our strategy. We add 'unique values' to the existing drugs. We have several international patents on our novel drug delivery systems. In fact, we are using the opportunities provided by new product-patent regime by investing considerably in R&D in identified strategic biotech areas. We hope to get leads for new drugs, therapeutic and vaccines in years to come. This would also add in to generating our own IPR," Rajesh Jain added. Issues of concern Before the Act came into force, the general public and the NGOs had a perception that the prices of medicines will go through the roof top. But the post-IPR regime has turned out to be a myth as expected. In fact, Dr Ajit Dangi said that the 2005 November MAT ORG/IMS numbers show that overall there is only one percentage point growth due to price increase over 2004. Dr Swati Piramal, director, strategic alliance and communications, Nicholas Piramal India Ltd, Mumbai, also shared similar opinion. She said, "There is competition in the market and prices have fallen in reality. As against the general notion of price hike after India entering the patent regime, the prices in reality have fallen. Still 98 percent of the drugs are off patent and are already available in India. So there is not much difference." However, Dr Ajit Dangi observed that the much awaited National Pharmaceutical Policy Part A (Draft) has been announced and it is hoped that government will move from micro managing price control to price monitoring. Compulsory negotiation of price before introducing a patented product as suggested in this Policy could, however, be a dampener and will erode India's credibility in implementing IPR regime in a fair and transparent way and might seriously affect the introduction of newer patented drugs in the country resulting in non-availability of many modern therapies to Indian patients. Overall the situation still remains as "work in progress". On the pricing front nothing much has happened at present by the switch over, yet the awaited National Pharmaceutical Policy will have to be looked at seriously. "This seeks to ensure that existing products in the market are not immediately and significantly impacted by the switch over to the product patent regime. But in the long term, the product patent regime will have a far-reaching impact on the domestic pharmaceutical industry as the new product introduction will become increasingly difficult for Indian companies. This will significantly alter the structure of the Indian pharmaceutical industry and the pattern of new product introductions in the country. In future, introduction of patented drugs by Indian companies would be possible largely through in-licensing arrangements with patent holders. Two to three years from now, this would start having significant implications in terms of ageing of product basket for most pharmaceutical companies in India. Domestic companies would need to re-align their geographical coverage, research and manufacturing strategies to meet the imperatives of the product patent regime," said Kirit Javali, partner, Law Offices of Jafa & Javali Advocates, New Delhi. In addition to pricing, issues such as narrowing the definition of Patentability, broadening the scope of Compulsory Licensing and lack of Data Protection continue to be areas of concern from the perspective of international research based companies, appointment of several committees to look into these areas gives some comfort. "It is understood that the report of these committees will be out very shortly," said Dr Ajit Dangi. Things are moving at the government level but in reality much needs to be seen. The government has to expedite the process. Only then can the Indian companies look at competing in the era of globalization and competition. "In the US it takes just two years to get the approval for product patent. But in our country it will be definitely more than that. Things are improving. The government has to appoint more examiners. There should be more patent attorneys. As far as I know, no patents were granted in product section so far from the Indian patent office," adds Dr Swati Piramal. On the other hand, Kirit Javali said, "Intellectual Property is a specialized subject needing specialized expertise and knowledge to deal efficiently and expeditiously. The establishment of an Intellectual Property Appellate Board is a recognized system, which already exists in many countries, including in India under the Trade Marks Act, 1999. We do require specialized fast track courts for exclusively deciding IPR matters. For this it would be prudent to set up an IPR Tribunal on the lines of the MRPT Commissions and other such tribunals. All this would be in the interests of the industry as companies have invested heavily in technology, time and resources." "The power of mass intellect is the power of India today. The brain product is the future of Indian economy. The Intellectual Property or the brain products are to be protected properly by IPRs to strengthen economy. Indians can do that, they have the capability no less than others. The only thing to do is 'To enhance awareness of IPRs' and 'To reduce fearness of the same' amongst the common people.Rather it is the time to accelerate a mass program like 'Patent For Public (PFP)' and only then India will be able to compete with the whole world. I believe India is already moving on the right path, " says S Chandrasekaran, Controller General of Patents, Designs and Trade Marks. A long way to go India kept its promise with the WTO and brought in the Patents (Amendment) Act 2005. The Act attempts to combine the inventive spirit of scientists with the innovative spirit of private sector enterprises. India has an advantage in terms of large manpower, educational institutions, public funded research institutions, which places the country to take up the challenges and take on multinationals. As noted earlier, the big pharmaceutical companies are considering bio/generics and contract research/manufacturing as a growth model. It may not be possible for them to grow beyond a certain point through this route. These models could be applied to supplement the strategy of expanding the domestic market. But to mainly depend on these for the further growth would take the Indian companies away from innovation. They just can't afford to take a risk on investing huge sum on innovation. Varaprasad Reddy, managing director, Shantha Biotechnics said, "One can't take up research activities/ innovation without resources - both capital and human resources. The life sciences and biotechnology companies are losing the best talents to the IT industry because of the high returns there. Here the gestation period is also long and returns are low." The government has to bring both public and private sectors together on research and development in number of areas. It has to pump in more investments into R&D activities. Offering incentives to private sector will support them to concentrate efforts on need-based innovations and those strategies that would largely free Indian firms from getting into dependent relationships with multinationals. The companies should also look at adopting the model of IPR compliance which involves training of existing personnel as technology mangers or appointment of new personnel with pharma/biotech background as persons dedicated to acquisition of R&D benefits from academic and research institutes. It will support the firms to acquire global competitiveness, protecting business and enhancing profits. In this regard firms have taken steps and have separate IPR cells. "India is at a crucial juncture where it is emerging out of its protective oyster onto the open arena. Like a new born wilder beast it will have to sense the world and get on its feet with speed to strategically escape global predators and chart its course for survival and growth and service the needs of a growing society with accessible and affordable products and services with accountability and responsibility," said Prabuddha Ganguli, CEO, VISION â€“IPR, New Delhi. In spite of all these issues, Nitin Deshmukh is optimistic about the future of patent regime in India. He says, "Considering the present scenario we can hope that Indian biotech companies can apply for product patent in next 5-6 years." Biotechnology and patents There are other issues as far as patents and biotechnological inventions are concerned. According to World Intellectual Property Organization (WIPO), the issues surrounding patents and biotechnological inventions can be grouped into a number of categories, which are partly inter-related. These following issues could be resolved through discussion and continuous debate. The first area of concern relates to the legal standards in respect of the scope of patent protection for inventions in the field of biotechnology. The question as to whether certain substances isolated or derived from naturally occurring living organisms are "inventions" or "discoveries" has triggered widespread discussion. In addition to the question of patentable subject matter, the appropriate application of the patentability requirements, for example, inventive-step, industrial applicability (utility) and disclosure requirements, to biological inventions has been subject to an intense debate. Since the exclusive right conferred by a patent is justified by the public disclosure of the full scope of the patented invention, defining the breadth of the claims which are supported by the disclosure of the invention, is a cornerstone of the patent system. Secondly, licensing and other issues related to the exploitation of patents are also areas of discussion. Since one of the characteristics in the field of life sciences is that it requires a broad range of comprehensive research activities, down-stream innovations may be covered by a broad patent granted at an early stage of innovation. The number and breadth of patents granted to early fundamental research have raised concerns about patent thickets and royalty stacking. In particular, reach-through claims in patents, especially for research tools, were flagged as a potential impediment to further research and development. Since universities and governmental research institutions also play an important role in the area of biotechnological research, it is essential to stimulate public-private partnership, generate revenue and protect investments. Facilitating the transfer of technology from basic research to applied research and commercialization is one of the key elements for the successful research and commercialization of biotechnological inventions. Thirdly, issues arise concerning the relationship between patents and other forms of intellectual property protection. In the field of plant biotechnology, plant varieties are, in many countries, protected by a sui generis system, such as the UPOV system. In the era of post-genome research, innovation in the area of, for example, bioinformatics, is characterized by biological information and its processing methods. Copyright protection and protection of databases, if available, are other forms of intellectual property protection, which may be of relevance in this area. Finally, the relationship with other relevant issues, such as the conservation and preservation of the environment (including the protection of biodiversity), and moral and ethical dimensions of the protection and commercialization of biotechnological inventions has been discussed in many fora. Narayan Kulkarni with inputs from Rolly Dureha ]]> <![CDATA[IT in the life sciences]]> https://biospectrumindia.com/news/95/2009/it-in-the-life-sciences.html https://biospectrumindia.com/news/95/2009/it-in-the-life-sciences.html Thu, 09 Feb 2006 11:28:00 +0530 IT in the life sciences IT in the life sciences For most of the IT software and services companies today, life sciences is a high growth vertical. The IT software and services sector in India in 2004-05 was Rs 98,959 crore, according to the leading IT magazine, Dataquest. The industry has been growing at the rate of 37-40 percent and for most of the IT services companies, the banking and financial industry, telecom, manufacturing, and government sectors are the most lucrative segments for most of the IT services companies. However, what is lesser known is that most of the companies today have a life sciences sector focus. Apurva Chamaria, head, marketing, life sciences vertical, HCL, said, "HCL focuses on the biopharmaceuticals and CRO space in the life sciences segment. It focuses on the hospitals (providers), biopharmaceutical companies and drug device manufacturers (players), and the CROs (service providers). Started about four years back, this is the fastest growing vertical at HCL. This venture was set up seeing a lot of client interest for solutions in the life sciences arena, especially in the area of clinical trial data management, regulatory compliance software etc. Since HCL was not the first mover in this area, it imbibed things, hired domain experts, built up competencies and thus has a more complete range of products now." The company's vertical is called the "Global Life Science and Healthcare Practice". Since its clientele is spread across the globe in Japan, the US and the Europe, it has tie-ups with institutes and companies spanning different countries - Tokushina University, Japan, IIT Delhi, India, Synchron, a CRO. Even the company's workforce working in this segment is spread across different continents - America, Europe and Asia. The focus of several IT software companies has spread to the life sciences vertical as they realize that that the global life sciences industry today is entangled between pricing pressures and the spiraling costs of drug discovery. Dr Joachim Kreuzburg, Group CEO, Sartorius Group, said, "The biotech revolution, which began in the labs about 15 years ago, now hits the production phase. And process optimization becomes a key driver for further growth. Also the patent expirations and the expanding market for low-cost generics have heightened competitiveness in the marketplace. Also stringent regulatory measures are making it harder for companies to bring new drugs to the market, safety issues are leading to product withdrawals. The greatest need is to escalate productivity and cost-effectively." These are some of the basic reasons for the Indian IT services companies to have focused on this sector. Take for example, Tata Consultancy Services (TCS). It is offering an entire gamut of solutions to the life sciences industry - from bioinformatics to clinical trials. It provides customized and cutting-edge solutions in the areas of clinical trials and US FDA compliance requirements to significantly reduce the effort and costs involved for pharmaceutical companies in the R&D process. TCS in September 2005 announced an agreement with Congenia, a biotechnology start-up promoted by Italy's Genextra Spa group to provide advanced fragment-based lead optimization solutions for drug discovery. In fact it is believed to be the first of its kind for an IT company. The life sciences R&D division of TCS will work on "P66", a target protein identified by Congenia as a key protein involved in several age-related diseases and will develop optimized drug leads based on this. Dr M Vidyasagar, executive vice-president and head of TCS' Advanced Technology Centre, Hyderabad, which houses the life sciences R&D division along with other activities, said, "This is a historic occasion for TCS and the first contract where the deliverable is not software code, but a set of molecules. We are proud to partner with the Genextra group, a biotech pioneer in Italy." TCS is committed to putting in place a complete suite of offerings in the life sciences segment, spanning genomics and proteomics, database integration, drug discovery, and preventive healthcare, Dr Vidyasagar added. "The life science sector has been identified as one of TCS' growth engines for the future. We have invested in developing competencies and research collaborations over the last few years and it is good to see that our investments are yielding significant results," said S Ramadorai, CEO and MD, TCS. India has been a major resource. Wim Cypers, vice president, product management, Aris Global, a global leader in the area of pharma safety software, informed, "The company's successful position in the pharma and biotech industry, where it counts over 120 customers, can be attributed to Aris' sole software development center in Bangalore that houses over 370 employees." Aris Global has plans to expand its product development center in Bangalore. The company started this center here as early as 1987. "We have products in four domains - pharma drug safety, regulatory compliance, clinical trials and medical communications," added Cypers. In the life sciences arena, the IT companies are focused on software products and services related to drug discovery, drug development, regulatory compliance, manufacturing, IT systems, marketing and sales. HCL has eight of the 15 global pharmaceutical companies as its clients. Infosys, another leading player in the country, has a dedicated practice for the vertical. It has drug discovery informatics solutions to accelerate target and lead identification, a streamlined clinical development solution to reduce the time and cost of clinical trial programs, and pharma regulatory compliance solutions. It has Connect solution to help collaborate effectively and enhance workflow efficiency. "We are bullish about our life sciences segment growing," said Vibhav Garg, principal-business development, Mascon Life Sciences. Mascon Life Sciences, a division of Mascon Global Ltd, was set up to provide solutions requiring combination of expertise in biotechnology and information technology. The bioinformatics center was set up in November 2001, by combining the synergies of its IT consulting experience with the domain expertise of Mascon Life Sciences and the bioinformatics center at Jawaharlal Nehru University, New Delhi. "We aim to provide world-class products and services in bioinformatics and seek to establish Mascon as a world-renowned center for research and development in computational biology," added Garg. "The healthcare and life sciences are important growth areas for Mascon Global Ltd. We have started with bioinformatics, which is our entry into this arena. We are planning to enter the global arena of bioinformatics services like offshore support for drug discovery in the in silico area and may also tie up with some wet labs," he informed. Persistent Systems has a suite of data management solutions for biomarker discovery encompasses the whole spectrum - from laboratory-based solutions to provision of real-time information to scientists working with real-life problems. It offers both services and solutions. Its services include data curation, management, warehousing and visualization, custom-built applications and web-based portals and solutions like microarray portal solution, LIMS for proteomics, microarray and sequence data, analyses tools, post-genomic data warehouse and gene annotation tools. Similarly, Cognizant has been delivering solutions for the life science industry for a decade. Its association with IMS has helped it to gain in-depth understanding of the pharmaceutical industry. It provides solutions like application management for legacy systems, e-Business, data portals, ERP implementation, upgrade, and maintenance services, prescriber behavior analysis and insight, longitudinal prescription data management systems, clinical trial solutions, and 21CFR11 assessment solutions. Mphasis has become an outsourcing partner in the field of bioinformatics developing software solutions that address requirement in combinatorial chemistry, visualization tools for genomic studies, micro-array analysis and plant genomic data analysis. It has been offering services such as analytical instrumentation, molecular informatics (data analysis), data management, image analysis, algorithm development, compliances, agro biosciences and document management system. Satyam's pharma and life sciences practice offers a wide range of IT solutions for pharmaceutical companies, CROs, medical equipment manufacturers and biotech organizations. Satyam has also launched its Grid Computing Practice. Oracle, to the life sciences industry, offers more than 30 products to address the specific issues that pharmaceutical and medical device companies face. Oracle's life sciences applications are focused on products that can manage resources and costs across discovery, development, manufacturing, and marketing teams and also accelerate and optimize the discovery pipeline, reduce risk, and streamline sales and marketing efforts. Sun Microsystems has set up a dedicated Center of Excellence (CoE) for bioinformatics with the Centre for DNA Fingerprinting and Diagnostics - Sun Microsystems Medical Bio-informatics Center of Excellence in Hyderabad to address this vertical. Clearly for these IT companies, healthcare and life sciences sector is a very important focus area.   Ch. Srinivas Rao with Rolly Dureha and Narayan Kulkarni     ]]> <![CDATA[India shows three fold increase in acreage of Bt cotton: ISAAA]]> https://biospectrumindia.com/news/95/1818/india-shows-three-fold-increase-in-acreage-of-bt-cotton-isaaa.html https://biospectrumindia.com/news/95/1818/india-shows-three-fold-increase-in-acreage-of-bt-cotton-isaaa.html Thu, 09 Feb 2006 11:14:00 +0530 BioAgri BioAgri India shows three fold increase in acreage of Bt cotton: ISAAA Indian farmers plant 1.3 million hectares of biotech cotton, up 160 percent from 2004 India experienced the highest yearly percentage growth rate increasing its Bt cotton area by 160 percent in 2005. The country displayed the largest proportional growth, nearly three-fold, by planting 1.3 million hectares of Bt cotton in 2005 compared to 500,000 hectares in 2004, according to a report authored by Dr Clive James, chairman and founder of ISAAA, the International Service for the Acquisition of Agri-biotech Applications. Around 10 lakh resource poor farmers elected to plant Bt cotton in the northern, central and southern cotton growing zones which is a three-fold increase over 2004. Overall the country grew to the seventh largest adopter of biotech crop, the report revealed. Source: Clive James, 2005 During the year, 16 new varieties of Bt cotton hybrids belonging to four companies (Ankur Seeds, Mahyco-Monsanto, Nuziveedu Seeds and Rasi Seeds) were released totaling to 20 Bt cotton hybrids. Three companies (JK AgriGenetics, Nath Seeds, Syngenta) received permission for large-scale field trials of biotech cotton with different genes in 2005. Presently, more than 25 companies are developing different varieties of biotech cotton hybrids with different genes and with staked genes/multiple traits i.e., cry1Ac, cryAb, GFM-cry1Aa, Vip-3a, cry1Ac+cry2Ab said the report. The University of Agricultural Sciences, Dharwad along with the Central Institute for Cotton Research (CICR), Nagpur is developing its own biotech cotton varieties employing Bt gene and is likely to be made available to farmers soon. The approval of more numbers of Bt cotton hybrids is likely to grow further in 2006 and researchers are exploring the future potential for multiple traits in biotech cotton. Summing up the global biotech crop scenario, the report stated that worldwide farmer demand has driven annual double-digit increases in biotech crop adoption since the crops were commercialized a decade ago. In 2005, four new countries and a quarter million more farmers planted biotech crops as part of an 11 percent increase in global biotech crop area. Since initial commercialization in 1996, global planted area of biotech crops has soared by more than fifty-fold from 1.7 million hectares in six countries to 90 million hectares in 21 countries in 2005. The 8.5 million farmers planting biotech crops in 2005 also marked a significant milestone as the 1 billionth cumulative acre or 400 millionth hectare was planted. Commenting on the adopted traits, it said that the herbicide-tolerant soybeans continue to be the most widely adopted trait, accounting for 60 percent of the total global area. Varieties with stacked traits are growing in popularity, accounting for 10 percent of the global area. In 2005, 100 million "trait hectares" were planted, which better quantifies those hectares planted to varieties with multiple biotech enhancements. "Farmers from the United States to Iran, and five EU countries demonstrate a trust and confidence in biotech crops, as indicated by the unprecedented high adoption rate of these crops," said Dr James. "The continued expansion of countries growing biotech crops also bears witness to the substantial economical, environmental and social benefits associated with these crops." Notably, in 2005 Iran grew its first crop of biotech rice, the first biotech planting of this important food crop globally. The Czech Republic planted Bt maize for the first time, bringing the total number of EU countries growing biotech crops to five with Spain, Germany and the Czech Republic being joined by France and Portugal, which resumed planting biotech maize after four and five year gaps respectively. This could signal an important trend in the EU. Two-thirds or 14 of the 21 countries growing biotech crops achieved "mega-country" status by planting 50,000 hectares or more in 2005, including the US, Argentina, Brazil, Canada, China, Paraguay, India, South Africa, Uruguay, Australia, Mexico, Romania, the Philippines and Spain. Brazil experienced the most significant growth, increasing its biotech soybean area by 88 percent to reach a provisional 9.4 million hectares in 2005. In India researchers are working on several Genetically Modified (GM) food crops. A total 14 field, vegetable and commercial crops are under advanced stage of development at various institutions in India such as rice, mustard, maize, sorghum, tomato, potato, groundnut, cauliflower, cabbage, chickpea, okra and pigeonpea. The GM eggplant is under near term approval. State-wise adoption of Bt cotton in India State 2004 (ha) 2005 (ha) Rank 2004 Rank 2005 Maharastra 200,000 590,000 1 1 Gujarat 130,000 150,000 2 3 Madhya Pradesh 85,000 145,000 3 4 Andhra Pradesh 80,000 280,000 4 2 Karnataka 18,000 30,000 5 6 Tami Nadu 10,000 25,000 6 7 Northern Zone (Punjab, Hr, Raj) N/A 60,000 N/A 5 Total 500,000 13,00,000 When biotech crops were first commercialized, critics suggested the technology would never be valuable in the developing world. Now, resource-poor farmers in developing countries account for 90 percent of the 8.5 million growers who benefit from biotechnology while developing nations represent more than one-third of 2005 global biotech area. "Biotech crops have increased the income of 7.7 million resource-poor farmers in China, India, South Africa, the Philippines and seven other developing countries, helping alleviate them from abject poverty," Dr James said. "The broader commercialization of biotech rice, the most important food crop of the world's 1.3 billion poor and the 850 million hungry and malnourished, can further this effort. Biotech rice could make a substantial contribution to the formidable UN Millennium development goal of reducing poverty, hunger and malnutrition by 50 percent by 2015." Dr James indicated the future looks promising for continued increases in adoption levels in the next decade. "I am cautiously optimistic the stellar growth experienced during the first decade of commercialization will not only continue but will be surpassed in the second decade," he said. "The number of countries and farmers growing biotech crops is expected to grow, particularly in developing countries while second-generation input and output traits are expected to become available," he added. According to the report, other indicators of continued growth include China's expected near term adoption of biotech rice, more nutritional biotech food and feed, products and the anticipated introduction of novel crop products used as renewable resources for more sustainable and affordable production of biofuels. ISAAA projects the global value of the biotech crop market to increase from $5.25 billion in 2005 to $5.5 billion in 2006. ]]> <![CDATA[CPI International launches medium for coliform testing]]> https://biospectrumindia.com/news/95/7013/cpi-international-launches-medium-for-coliform-testing.html https://biospectrumindia.com/news/95/7013/cpi-international-launches-medium-for-coliform-testing.html Thu, 09 Feb 2006 11:09:00 +0530 CPI International launches medium for coliform testing CPI International launches medium for coliform testing US-based CPI International has launched Colitag, which is a selective and differential medium for the enumeration of total coliforms and E. coli in drinking water, surface, and source water samples. This is a one-step, ready-to-use medium, to be combined with a water sample. The product is designed to test water or other samples for coliform and/or E. coli bacteria in 24 ± 2 hours and does not require further confirmation or verification steps. Colitag detects 1 colony-forming unit (CFU) of E. coli and other coliform bacteria per 100 ml water sample. It detects both MUG-negative and MUG-positive E.coli in one test and includes built-in ability to detect E.coli using the reliable indole test. Colitag is being distributed in India exclusively by Delhi-based Genetix Biotech Asia. For details, contact: genetix@genetixbiotech.com Sigma introduces iLAP columns Sigma, a division of Sigma-Aldrich Corporation has launched a new HIS-Select Integrated Lysis and Affinity Purification (iLAP) 5 ml Column (Product code H9913). The HIS-Select iLAP column is an innovative, patent-pending method that combines cell lysis and histidine- tagged protein purification steps into one step, allowing fast, efficient and non-denaturing protein extraction directly from microbial cultures. The HIS-Select iLAP column consists of a novel single-use, disposable column designed for the one-step purification of histidine-tagged proteins directly from a 5 ml bacterial culture. This product maximizes the speed and efficiency of recombinant protein extraction while eliminating sample loss. The column contains highly specific HIS-Select nickel chelate matrix and highly efficient CelLytic Express, both present in a convenient tablet format. The column is designed for the simultaneous, direct lysis of a 5 ml bacterial culture and affinity capture of the target histidine-tagged protein without any additional manipulation required (such as centrifugation). As the culture is lysed in the column, the target protein is captured on the same highly selective HIS-Select Affinity Gel. The resulting purified protein is compatible with protein assays, SDS-PAGE, Western blotting and MALDI. For details, contact: somhamed@sial.com LabVantage releases Sapphire R4.4 LabVantage Solutions has announced the availability of its new release Sapphire R4.4. Sapphire R4.4 has new features and benefits including: Architectural Enhancements, Enhanced Scheduling, M18N Internationalization, Improvements, Advanced Analytical Quality Control Functionality, Programmable Business Rules, New Archiver Module, Improved Patching Capabilities, Clustering Module, Evergreen Configuration Tool Enhancements, Enhanced Stability & Shelf-Life Testing Module, LDAP Capabilities and BioBanking Module. As an added benefit to current maintenance and port customers, LabVantage announced that it would perform free virtual installations and upgrades of Sapphire on any licensed server. For details, contact: kingshukd@labvantage-asia.com Alfa Laval offers SaniJet 25 cleaning device The SaniJet 25 cleaning device from Alfa Laval is the first ever dynamic tank cleaning machine designed for use in ultra-hygienic industries including biotechnology that follow European Hygienic Engineering and Design Group Guidelines (EHEDG). SaniJet 25 is a sanitary cleaning device of the rotary jet head type. It cleans in a 360° indexed pattern ensuring that the cleaning media covers the entire internal surface of the tank. The device is designed for permanent installation. It is completely self-cleaning and self-draining and provision for cleaning the downpipe. All product contact surfaces are either 1.4404 (316L) stainless steel or FDA approved polymer materials. All product contact surfaces are polished to 0,8 micrometer or better. The SaniJet 25 is as a standard delivered with a 2.2 certificate of compliance, but 3.1 B full traceability certificate is available as an option. Furthermore, product contact surfaces polished to 0,5 micrometer is also available as an option. The design and material selection complies with cGMP guidelines and with FDA requirements. It is suitable for use in fermentation, mixing, processing and storage tanks and vessels from 15 and 150 m³. The SaniJet 25 is especially well suited for cleaning applications of highly viscous, foaming or thrixotropic products and applications where reproducible and high standard cleaning results are required. The machine uses jets of cleaning media to provide full impact coverage of all internal surfaces of the tanks. Plant downtime for cleaning is minimized using impact coverage. For details, contact: bvk.rao@alfalaval.com ]]> <![CDATA[Thermo opens demo center in India]]> https://biospectrumindia.com/news/95/2360/thermo-opens-demo-center-in-india.html https://biospectrumindia.com/news/95/2360/thermo-opens-demo-center-in-india.html Thu, 09 Feb 2006 11:02:00 +0530 Marijn Dekkers Marijn Dekkers Thermo opens demo center in India Thermo Electron Corporation has opened a new customer demonstration laboratory in Mumbai to serve the local pharmaceutical, petroleum/petrochemical, automobile, environmental and agricultural market sectors. The new center is equipped with state-of-the-art customer demonstration and training facilities. The new facility offers customers with hands-on experience with Thermo's laboratory and manufacturing process solutions. The demonstration center has a house laboratory and life sciences solutions including ion trap and triple quadrupole mass spectrometers, centrifuges, incubators and microplate instruments, along with several process instruments. Customers visiting the facility will have the opportunity to receive training on these solutions and will be able to analyze samples before making purchase decisions. The new facility in Mumbai is one of three major centers Thermo has opened over the past two years. Early November, Thermo opened a 43,000 sqft customer service and demonstration laboratory center in Shanghai, China. Speaking at the inaugural function, Marijn Dekkers, president and CEO of Thermo Electron Corporation said, "The new facility in Mumbai is part of our associated global business strategy and planned development activities. Housing excellent customer demonstration and training facilities, the new site will help Thermo to successfully foster a culture of innovation and respond to our customers needs in this region." He further said, "Building Thermo's capabilities throughout India and across Asia is a logical and important part of this growth strategy. India and the surrounding regions represent a major market for laboratory and process instrumentation, and therefore, a tremendous opportunity for long-term growth and expansion for Thermo." Agilent Technologies expands HPLC-Chip/MS with five new chips Agilent Technologies has expanded its line of high-performance liquid chromatography (HPLC) chip/mass spectrometry (MS) modules, introducing five chips for the study of small and large molecules. Agilent's HPLC-Chip technology combines nanoflow HPLC with an electrospray ionization source in a reusable microfluidic chip, which is smaller than a credit card. Agilent's first two HPLC-Chips, the Protein ID chip and the MS Calibration and Diagnostic chip, were introduced about a year ago. Based on enthusiastic customer response, Agilent developed the additional five chips to cover a wider range of applications. The HPLC-Chip/MS makes the dramatic sensitivity increases promised by nanospray LC/MS attainable by more researchers, thanks to elimination of half the fittings and connections of conventional nanoflow LC/MS systems. This reduces the potential for leaks and dead volumes while significantly simplifying workflow and reliability. "Agilent strives to streamline customers' entire workflows," said Chris van Ingen, president of Agilent's chemical analysis and life sciences group. "The plug-and-play aspects of these chips unlock the profound benefits of nanoflow analysis for researchers hindered by the complexities of conventional nanoflow systems." Praj Industries entering developed countries Praj Industries, a global player in ethanol technology is entering the developed markets of the EU and the US. A breakthrough order has been received from a European beet sugar company for engineering and supply of equipment for the very first fuel ethanol project to be set up in the UK. Praj has been working with a number of feed stocks for ethanol production and has set up plants based on maize, sorghum, rice and even tapioca. "With production of ethanol doubling the world over, it is expected that opportunities will also expand. As envisaged, we see a surge of interest in ethanol as a fuel amongst countries as small as Malawi to as large as the US. It just shows that ethanol is here to grow and will become only more attractive as the usage increases," said Pramod Chaudhari, chairman, Praj Industries. "In India, there is an expansion in the market also due to beverage alcohol which is being produced from grains. As ethanol becomes writing on the wall, we will see more and more interest in grains. We are treating this year as a consolidation year in preparation of the volume growth in business in the coming period. These opportunities are expected to give Praj a major fillip in the coming year," added Pramod Chaudhari. Praj has already started gearing up in the past 6-8 months. It has already invested in expansion of its manufacturing capacity and R&D facility. The technical manpower base has also gone up. It has demonstrated its commitment to customers in India and overseas by investing in innovative solutions at its R&D Center. QIAGEN, Eppendorf tie up to deliver life science solutions QIAGEN N.V. and Eppendorf AG have formed a strategic alliance that includes co-development and co-marketing of complementary and optimized products. The alliance is intended to link two of the strongest brands and product lines in the industry to ensure the highest compatibility of their products targeting the research, applied testing and molecular diagnostics. Through the alliance, QIAGEN and Eppendorf intend to focus on improving biological sample management and analysis. The availability of combined and optimized products should create significant benefits for customers in research, applied testing and molecular diagnostics. In addition QIAGEN has acquired Eppendorf's reagent business that includes the Eppendorf "5-Prime" nucleic acid sample preparation and PCR reagent product lines and related intellectual property. The acquired assets represent an attractive portfolio of preanalytical and nucleic acid amplification consumables as well as a very promising pipeline of proprietary technologies for nucleic acid handling, separation, purification and amplification. The assets add to QIAGEN's core strategic focus. Financial terms of the transaction were not disclosed. QIAGEN expects the business to add $6 million in net sales in 2006 and $11 million in 2007 and be slightly dilutive to earnings per share based on net income excluding acquisition and restructuring charges by $0.01 in 2006 and accretive to earnings per share based on net income excluding acquisition and restructuring charges by $0.01 in 2007. QIAGEN expects to incur one-time charges relating to the acquisition of approximately $3 million in the fourth quarter 2005. Robert Honor "Adopt science-based manufacturing to reduce costs" "Life sciences companies can lower costs, improve yields, reduce inventory and provide product faster to the market if they adopt science-based manufacturing widely, " said Robert Honor, vice president - life sciences industry, Rockwell Automation, USA. Honor who was in Mumbai recently informed that due to risk average nature, the life sciences companies have been slow to adopt. But he noted that the change has been happening. "The recent trends to improve manufacturing in all aspects come from changes in regulators. First, acceptance of risk based approach to simplify operations. Second, science-based manufacturing instead of traditional process recipe-based manufacturing. The introduction and acceptance by FDA of process analytical technology (PAT) is the prime example," he said. To help the life sciences companies to solve their short-term business needs as well as to achieve a long term strategy for success, he said, "Rockwell brings a wealth of experience to the life sciences industry to 100 years of knowledge improving manufacturing operations. For this four key goals could be accomplished, namely faster time to market, more efficient operations, better asset utilization and reduced regulatory risk." ]]> <![CDATA["Multi vendor compliance services can be used by scientists across the disciplines"]]> https://biospectrumindia.com/news/95/2442/multi-vendor-compliance-services-can-be-used-by-scientists-across-the-disciplines.html https://biospectrumindia.com/news/95/2442/multi-vendor-compliance-services-can-be-used-by-scientists-across-the-disciplines.html Thu, 09 Feb 2006 10:33:00 +0530 New Page 1 "Multi vendor compliance services can be used by scientists across the disciplines" Dr Ludwig Huber, validation and compliance expert, Agilent Technologies. Dr Ludwig Huber has published over 70 papers on validation and compliance and 21 CER Part 11 and authored many books. In an exclusive interview, he speaks about the role of lab compliance in the times to come. Excerpts: How crucial will be the role of laboratory compliance in the life sciences/pharma arena in the future? Laboratory compliance has always been necessary. It is crucial for service companies developing and manufacturing products that are marketed in the US and Europe. If a company is developing a drug and wants to tap the international market, then it does not have an alternative. It has to comply with the international regulations. It is interesting to look at the origin of these regulations - where did they really come from? They always came at a point when the industry was having a problem with drug safety or drug development. For example, the Good Manufacturing Practice (GMP) was developed in the early Sixties and was filed as a rule when there was a problem with drug development. The Good Laboratory Practice (GLP) was developed in the US in the late Seventies when the Food and Drug Authority (FDA) identified some problems in the developmental stage of drugs. So whenever there has been a problem, the regulators come up with new regulations. It has been observed that the regulated area is more focused on pure drug development. Hence there has been a shift from strictly manufacturing and late stage development to the early development stage now. As the FDA would like to have documented evidence that all the tests have been well developed under control, now compliance will become more important because of the increased use of electronic records. Worldwide, compliance is increasing and it has also been a part of the FDA regulated industry. Can you elaborate on the multi vendor compliance service that was recently launched by Agilent Technologies? How has been the response till date? Going a little back, around the 1990s, we realized after extensive interaction with the pharma industry that there was a need to validate or qualify the instrumentation/equipment used in the industry due to the compliance regulations. That was the starting point when we developed a qualification protocol and services for our own products. Later on, the pharma companies were keen to have a globally applicable uniform compliance protocol, which is independent of the brand of the instrument. And this is what our multi vendor compliance program offers. This is applicable to the products of different vendors on a worldwide basis. The multi vendor compliance service is a platform, which can be used by scientists across the disciplines like pharma, biotechnology and life sciences. In addition there are similar compliance requirements in other industries too like the food industry and environment testing laboratories. In all these sectors the requirements are related to qualifying the equipment, revalidating the computers and software. But its usage is highest by the pharma industry. This service has just been launched for the first time across the world including India. The response has been very good because it fills a requirement, which has come up many times in the industry and people are very happy about it. How do you view the compliance market? Compliance has been predominated by the research and the pharma industry. So the way the pharma industry is growing, the compliance market is also growing. There is definitely a high rate of growth expected in the compliance industry in the times to come. India has a GNP deadline whereby all laboratories must comply with national regulations and guidelines. What are the essential steps needed and how can Agilent help in this area? The first step in this direction is to understand what compliance really means and build up the expertise. The best way to learn quickly is to go to those companies/organizations, which have experience in compliancy issues, which are working with US FDA and European agencies. It is mainly a training and learning exercise and then, of course, the next step would be to do an Asian analysis, to see what is already in place. Hence the requirements should be identified first, and then a gap analysis should be done after which comes the implementation plan on how to plug those gaps. Agilent had helped a lot of international companies in the area of compliance by giving seminars and we have organized many such seminars in India too. Now probably we will extend this service to the service companies serving the local markets as well. Rolly Dureha Barbara Mullin, sales and marketing manager - Japan, Korea and India regions, Corning Life Sciences Lydia A Kenton, business manager - cells platform, Corning Life Sciences. "Corning Life Sciences will increase its presence in India" Which Asian country has the greatest potential for cell culture products? Barbara Mullin: I have visited China and other Asian countries like Korea and Japan. In China, I visited some of the manufacturers. What I can say about China is that it is very efficient for in-country manufacturing, with bright and highly qualified people. Japan already has established technology for manufacturing, but has higher costs. Hence, the companies originally located in Japan are now looking at manufacturing outside the country. Some may relocate a portion of manufacturing to China, Singapore or India. Considering the growth of the vaccine segment, how do you see the opportunity for cell culture in India? The companies that have moved into India for manufacturing vaccines have set up state-of-the-art facilities to meet not only the local needs, but also to export to the world wide market. They have a qualified and skilled work force. The Corning brand is very well known and there are many opportunities for growth. At what rate is the cell culture sector is growing? In India the projected growth rate is extremely good. The growth rate is a factor of two different areas. We look at growth rate for our own products and the growth rate for the actual market. Some published market studies project a 25 percent annual growth rate for the life sciences market. Is it really going to happen? We don't know. Economics and time will tell. For Corning brand products, we do not discuss projected growth rates, but we do feel that the India region will provide the opportunity to significantly increase Corning Life Sciences sales. How do you see the competition? Who are the leaders in this space? There are three to four other manufacturers that we consider to be competitors, selling similar products. As a policy of the company, we do not disclose the names of our competitors. What are your future plans for India? Corning Incorporated, a world leader in specialty glass, has a 150-year tradition of innovation. Corning International has a business entity in India with a broad spectrum of business activities such as automotive environmental products, optical fiber, optical cable, and ophthalmic products, but the focus until recently was not on life sciences. That has changed in the last few years as the life sciences and biotechnology market in India has grown. Since mid 2004, we have had direct sales presence in India for life sciences. We have strengthened our field force by adding additional dedicated personnel for life sciences. We feel that countrywide distribution is the key factor for successful growth. Hence, we believe in having a multi-centric distribution network. Corning India is planning to establish a warehouse in Delhi. It will be operational by mid 2006. This warehouse will stock the most frequently ordered products and will shorten the order placement cycle for customers. In 2005, Corning Life Sciences offered for the first time, a web based scientific seminar series on topics from cell culture to microarrays. These seminars were given by Corning's technical marketing and applications team. The seminars were very well attended by customers worldwide, including customers located in India. What new technologies is Corning planning to launch in India? We have several new technologies of interest. We will launch a range of patented products for drug discovery, cell culture and high throughput screening in 2006. Recently, we introduced the Corning CellBIND Surface family of products. These products are particularly useful for vaccine producers and have generated a high level of interest from Indian companies. Narayan Kulkarni ]]> <![CDATA[Market for centrifuges has great potential in India]]> https://biospectrumindia.com/news/95/2170/market-for-centrifuges-has-great-potential-in-india.html https://biospectrumindia.com/news/95/2170/market-for-centrifuges-has-great-potential-in-india.html Thu, 09 Feb 2006 10:27:00 +0530 Market for centrifuges has great potential in India Market for centrifuges has great potential in India With India emerging as a leading vaccine producing hub in the world, the market for centrifuges has been increasing over the last few years. The encyclopedia defines centrifuge as a device using centrifugal force to separate two or more substances of different density, e.g., two liquids or a liquid and a solid. The centrifuge consists of a fixed base or frame and a rotating part in which the mixture is placed and then spun at high speed. Several stages of centrifuging are needed to effect the required degree of separation. It is an apparatus consisting essentially of a compartment spun about a central axis to separate contained materials of different specific gravities, or to separate colloidal particles suspended in a liquid. Centrifuges as stand-alone machines or integrated in complete process lines make possible the realization of new process techniques while at the same time making the production processes efficient and economical. The first successful centrifuge was built in 1883 by Carl GP de Laval, a Swedish engineer, whose design was used chiefly for cream separators. The ultracentrifuge, devised in the 1920s by the Swedish chemist Theodor Svedberg, found wide application in scientific research. Using an optical system with it to observe sedimentation rates, Svedberg determined accurately the molecular weights of substances including proteins and viruses. Centrifuges are also used for such diverse purposes as simulating gravitational fields in space and for drying laundry. There are many companies that have been manufacturing/ supplying various models of centrifuges to meet the needs of different industries like biotechnology, life sciences, pharmaceuticals, chemicals and food, textiles. The range of centrifuges used for different applications include manufacture laboratory centrifuge, manual top discharge centrifuge, lifting bag type centrifuge, bottom discharge centrifuge and portable and detachable basket type centrifuge, high speed centrifuge filters. In India there are more than 20 companies that are into manufacturing and supplying centrifuges. Companies like Jainsons (India), Zenith Glasswares and Instruments Corporation, Pawan Brothers, Chemo Fab Industries, PK Chemicals and Scientific Co. REMI Instruments Ltd, Sterling Manufacturing Company, are involved in the production of different types of laboratory scale centrifuges while Automed Systems, Axygen Scientific, Biocon Technologies, Biotech India, Genetix Biotech India, Imperial Biomedics, JH Bio Innovations, Medi Spec Instruments India Ltd, Shree Biocare India are into supplying centrifuges. In addition to manufacturing, AVExports and Biopro are also exporting centrifuges and micro centrifuge tubes respectively. Ramakrishnan, marketing manager, REMI Sales & Engineering Ltd, an exclusive marketing arm REMI Instruments Ltd, one of the leading local manufacturers of centrifuges (refrigerated and non-refrigerated) with market share of 75 percent in certain range of centrifuges, said, "The market growth is about 20 percent. The price for small lab scale centrifuges varies from a few thousands to a few lakhs of rupees. The centrifuges are used in different industries and also in pathology labs, research and development centers and clinical labs. The centrifuges used in the R&D labs of biotech and life sciences industries will cost about Rs 1.5 to 4.5-lakh/ unit." Arun Prakash, CEO, Genetix Biotech Asia Pvt Ltd, a supplier of a variety of centrifuges with other equipment to the life sciences industry, said, "The market for centrifuges has been growing at 30-35 percent. Besides distributors there are few manufacturers in India. The market for small laboratory centrifuges is about $15-20 million. There are more than 20 players in this space with distributors having a major market share." In addition to the local players, this market has the direct presence of multinationals like Sartorius, Thermo Electron Corporation, Alfa Laval and Westfalia Separator. Alfa Laval has a manufacturing unit at Pune while Westphalia Separator, a German company imports and supplies its range of centrifuges in India. These two firms are supplying high capacity and high-speed centrifuges for commercial production and pilot scale centrifuges. The first two are also supplying industrial centrifuges in addition to other range of centrifuges. NK Singh, marketing manager, Westfalia Separator India Pvt Ltd, a 100 percent subsidiary of the German company Westfalia Separator and supplying centrifuges to the leading biotech companies in India, said, "The market for centrifuges is growing in the last few years. There is good potential for centrifuges in the country. However, the growth is slow as against the biotech industry's growth. And it is difficult to comment on the pricing, as the products/equipment are tailor-made that meet the needs of the different industries customers. On an average about 10-15 high end units used in commercial productions would be sold in year in India." Sharing similar views, Prasanna Ghote, deputy general manager, life sciences - separation, Alfa Laval India Ltd, a leading provider of specialized products and engineered solutions including range of centrifuges, said, "We are mainly into the commercial and pilot scale centrifuge separator. The products are used in vaccine, insulin production. The market for centrifuges separation is growing very fast in the last few years than before. It is not a big volume market. I feel about 30 units of high-speed separators both SIP (sterilize in place) and non-SIP models would be sold in year in India. The price for high-speed centrifuge separators will vary from 400,000-one million euro." Narayan Kulkarni   ]]> <![CDATA[Awaiting Another Biotech Budget]]> https://biospectrumindia.com/news/95/1720/awaiting-another-biotech-budget.html https://biospectrumindia.com/news/95/1720/awaiting-another-biotech-budget.html Thu, 09 Feb 2006 10:17:00 +0530 Awaiting Another Biotech Budget Awaiting Another Biotech Budget All eyes are on Finance Minister P Chidambaram. Ever since he gave us a biotech-friendly budget in February 2005, the expectation levels have been raised. Over the last 12 months, BioSpectrum has taken the initiative to collate the other unfulfilled demands of the biotech sector and these wish lists have reached the policy makers. The expectation from the biotech sector is higher this time for other reasons too. Moreover, two key biotech policy makers, Minister Kapil Sibal and DBT Secretary, Dr MK Bhan, have been interacting with the industry regularly to get the feedback. Sibal's energetic work in handling the key science and technology portfolio has been duly appreciated and rewarded with the Cabinet rank given to him on January 29. With this elevation, Sibal has become one of the first full-fledged Cabinet minister to handle S&T portfolio. In the Vajpayee government, Murli Manohar Joshi handled S&T ministry as an additional charge to the HRD minister. Even the late President KR Narayanan had to operate only with the minister of state rank when he handled S&T Ministry in the Rajiv Gandhi government during 1984-89. With the Cabinet status, as one of the country Top 20 decision makers, Sibal should be in a position to get a better deal for the biotech sector, which he is very passionate about. As the budget details are being worked, this is the right occasion to highlight five major demands of the industry, once again. One, the customs and excise duty exemption given to the import of all raw materials required to make life saving drugs should be extended to all essential materials required in biotechnology and pharmaceutical research. India currently makes slightly over 50 biotech drugs. This exemption should help to make almost all the 350 biotech drugs which have been approved for use globally in a few years. Two, biotech products manufactured in India be given a two-year moratorium from Price Control under NPPA( National Pharmaceutical Pricing Authority) to provide for sufficient time to scale up production and streamline costs. The present requirement for approval from NPPA prior to launch leads to substantial delay in launch of the product. Further, R&D expenditure incurred on biotech products be permitted for amortization in computing costs for the purposes of price fixation. Three, the biotech parks availing of SEZ status should be allowed relaxed Export Obligation norms after a duration of five years as this will greatly help biotech parks to attract a large number of innovative biotech companies. And the minimum area required for setting up a Biotech SEZ be restricted to 25 Acres of land or 1 million sft of building area, similar to the norms specified for the IT industry. Four, lending to the biotechnology sector be categorized as Priority Sector Lending. Also it is proposed that Rs 200 crore of Funds under the Technology Development Board be earmarked for providing long term funds to biotech companies. Biotech imports should also be exempted from the Withholding Tax and the 200 percent weightage in tax deduction should be extended up to March, 31, 2015. International patent filing costs should also be allowed to be included in the weighted deduction calculation. Lastly, to enable small farmers to access the transgenic seeds, a subsidy scheme for such seeds should be announced. This would enable a larger number of farmers to access the beneficial transgenic seeds. Nearly two thirds of the costs of these seeds are paid as technology fee to the developers of technology. The biotech industry has great hopes on Mr Chidamabaram. If he concedes these five major demands, the industry could look forward to another great year ahead. ]]> <![CDATA[The promise of stem cell technology in India]]> https://biospectrumindia.com/news/95/3008/the-promise-of-stem-cell-technology-in-india.html https://biospectrumindia.com/news/95/3008/the-promise-of-stem-cell-technology-in-india.html Thu, 09 Feb 2006 10:10:00 +0530 The promise of stem cell technology in India India is relatively a new player in the stem cell arena. Nevertheless, stem cell researchers have already achieved some encouraging results. The right policies, public-private partnership, funding and an increasing scientific base will contribute towards strengthening India's global position over the coming years. Stem cell research is under the arc lights once again. The fabricated work of the South Korean scientist Hwang Woo Suk on cloned human embryos and stem cells has focused the attention of the global scientific fraternity on this nascent, sensitive yet innately potential arena. Scientists are realizing that research in the stem cell segment is a long drawn process especially in the wake of political, ethical and public pressure prevailing in some countries. But the promise of the technology is immense. It could pave the way for therapies of hard-to-cure diseases like diabetes and Parkinson's. Scientists hope to use stem cells as replacement parts for failing organs, as they have the potential to mature into almost any cell in the human body. India is one of the few countries where the government is largely supportive of research in this segment. Apart from a few private initiatives in the country, most of the efforts have been state sponsored. About Rs 8 crore have been spent on stem cell research in India in the last two years. The Department of Biotechnology (DBT) under the Ministry of Science & Technology is the nodal funding agency for supporting the stem cell R&D program. To date, more than 30 programs have been identified by DBT and supported for stem cell research that include establishment of human cell lines, limbal stem cells, haematopoietic stem cells, neural stem cells, liver stem cells, cardiac stem cells, human corneal stem cells, and stem cell preservation. Presently India has very little research work going on in human or animal embryo cloning. According to Prof G Padmanabhan, distinguished biotechnologist and honorary professor, IISc, Bangalore, "Stem cell therapy is a global business opportunity for India. The country can very well exploit adult stem cell therapy using cord blood cells and mesenchymal stem cells from the bone marrow. But there is a need for appropriate clinical trials even for autologous use". Centers with ongoing programs India is relatively a new player in this area. Nevertheless, stem cell researchers have already achieved some encouraging results such as the use of limbal stem cells from the eye to treat damaged corneas at LV Prasad Eye Institute in Hyderabad. Currently, several major institutes in India are engaged in stem cell research with most focusing on using stem cells to regenerate nerve, heart and adult muscle cells, and repair damaged bone tissue like the LV Prasad Eye Institute, Hyderabad, Christian Medical College, Vellore, National Brain Research Centre, Delhi and National Centre for Biological Sciences, Bangalore. At LV Prasad Eye Institute, under a DBT supported project, scientists have been able to generate a 1-2 cell layered epithelium from the limbal tissue without the use of a feeder-cell layer and air-water interphase. About 20 patients diagnosed with limbal stem cell deficiency have been recruited for cultured limbal stem cell transplantation. Results showed complete re-epithelialization of ocular surface in 2-6 weeks time. The group has also successfully cultured limbal stem cells on human amniotic membrane for limbal stem cell transplantation. Technology has been established at Christian Medical College, Vellore for the first time for clinical hematopoietic stem cell transplantation. This facility allows haplo-identical stem cell transplantation to be conducted for those patients with incurable hematological malignancies or genetic disorders. This technology is also being made available to other centers in India for application in their own places. Under the DBT supported project on liver stem cells at Centre for Liver Research Diagnostics (CLRD) and Centre for DNA Fingerprinting and Diagnostics (CDFD), Hyderabad, hepatic progenitors have been isolated from human fetal hepatocyte using CD34+ marker and have been characterized morphologically and biochemically using liver specific markers. The All India Institute of Medical Sciences (AIIMS) has successfully given stem cell treatment by 'injection method' to its cardiac patients. The institute conducted the study under the leadership of P Venugopal, a renowned heart surgeon and AIIMS, director, from February 2003 to January 2005, where 35 cardiac patients were given stem cell therapy and were monitored at six, 12, and 18-month intervals. All the patients were at a stage when their hearts were beyond bypass surgery and transplant was the only solution. After six months of treatment, 56 percent of the dead tissue area injected with stem cells showed improvement while after eighteen months, the improvement spread to about 64 percent of the necrotic area. These stem cells, derived from the patient or donors, act as repair agents within the body, multiplying continuously to replenish other cells. AIIMS has now been notified as India's nodal centre for conducting and coordinating stem cell research. Commenting about these developments and the current Korean stem cell controversy, Prof D Balasubramanian, director, LV Prasad Eye Institute and chair, DBT Task Force on Stem Cell Research said, "First, there is very little human embryonic stem cell applications done in the country. Much of the work has been on adult stem cells - such as of the eye and from bone marrow. The limbal stem cell applications have now been followed through for four years, and have also been done in several centers, so that the corneal surface reconstruction using limbal cells is now rigorous and acceptable from the scientific, ethical and clinical angles. The work by Dr Venugopal and colleagues at AIIMS is also good, since such work has been done elsewhere in the world before they did it, and they have learnt from earlier experience". Presently the DBT has envisaged big plans for creating infrastructure in the stem cell research arena. Dr MK Bhan, secretary, DBT, said, "The department has mooted plans to create a stem cell center at CMC Vellore with a funding of Rs 19 crore. This will be under a novel scheme of Centers of Excellence (CoE), which is quite different from what has existed in the past". Elaborating further about the CoE concept, Dr Bhan said, "These centers will be around gifted individuals where the new faculty positions would be mentored by this leader. Creating such CoEs will help create focus in research, introduce a larger element of teamwork and achieve a new measure of independence by locating the centers outside the department. We will be increasing the scientific oversight by putting in a scientific advisory committee apparatus to oversee these centers". Private initiatives In the private sector, Reliance Life Sciences (RLS) backed by the industry major Reliance Ltd has taken the lead. It ranks third among the top 10 institutes worldwide working on stem cells, as stated in an NIH report. The center was set up with an investment of $5 million in the cell biology facility in 2001. In the same year the embryonic stem cell work started as per the guidelines of the Indian Council of Medical Research and the National Institutes of Health, USA. The embryonic stem cell group is also focusing on basic research such as gene discovery, drug discovery and establishment of several transformed cell lines. The RLS's cell biology research activities are being carried out at Sir Hurkishondas Nurrotumdas Hospital in Mumbai and Reliance had pumped in Rs 100 crore for its upgradation in 1997. Presently the RLS has created a comprehensive genetic center as part of its cell biology group. The Reliance Group will be investing about $25 million in cell biology research that focuses on stem cells and tissue engineering. This covers embryonic stem cells, haematopoietic stem cells, skin cells, tissue engineering, genetics and molecular diagnostics. Another player in this arena is Manipal AcuNova, a collaborative venture between Manipal Education and Medical Group International India and AcuNova Life Sciences. Elaborating on its plans in this arena, DA Prasanna, vice chairman and managing director, Manipal AcuNova, said, "Stem cell activity has been conceived as part of Manipal AcuNova. Like the KMC life sciences center labs, we also have a stem cell lab for promoting discovery research and we intend doing that when our stem cell lab is ready. This lab is undergoing stabilization and is in Bangalore (Manipal Hospital) because this lab requires working closely with specialized doctors and in a cluster-like environment. We work close with NCBS and JNC. This stem cell unit is funded by DBT and other agencies". City cluster programs With a focus to expand the area of stem cell research for advantage for clinical applications in the country, the DBT is making efforts to promote city clusters programs at Delhi, Vellore, Hyderabad, Pune and Bangalore through an active and enhanced interaction and collaboration between basic researchers and clinicians. Significantly, a number of competent researchers and clinicians are already involved in stem cell research at these places. The aim of the clusters is to share information, explore collaboration with clinicians and discuss emerging policy issues. The department is also exploring a virtual network of these centers. "In Bangalore we are promoting a partnership between National Centre for Biological Studies (NCBS) and CMC Vellore. The idea is to strengthen CMC Vellore as a molecular medicine, translational and clinical research centre. We are likely to create a stem cell center there soon and then we would also like to set up a molecular medicine unit there. The stem cell cluster at Bangalore will consist of the Indian Institute of Science (IISc), NCBS, Manipal Hospital, CMC Vellore and one local company whom we are going to support for production. The missing piece here has been the company and now we have located and spoken to the company", shared Dr Bhan. "In Hyderabad we are trying to create another stem cell cluster. Both the stem cell clusters in Hyderabad and Bangalore would find their own niches. For example, one could specialize in mesenchymal stem cell research, while the other would be doing embryonic stem cell long sighted research. So they may have different niches, organs may be different, in one place they may be doing adult cell research and in another place they are specializing in neurological applications," he clarified, when queried about the necessity of creating similar facilities in multi cities. Presently the formulation of city clusters at other places in the country is under process. During 2004-05, DBT organized a meeting of stem cell cluster at Hyderabad and a network program was prepared for use of stem cells for therapeutic purposes in areas of ophthalmology, cardiology, diabetes and spinal cord injuries. Focused and targeted programs are being initiated on human stem cell research with the clinicians such as plastic surgeons, cardiologists, neurosurgeons, orthopaedicians and others after ascertaining their requirements for stem cell therapy. A proposal for program support on stem cell in the areas of haematology, cardiology, nephrology, neurological and gastrointestinal science is under consideration for implementation. The first component of this program involves isolation and expansion of Mesenchymal Stem Cells (MSC) that may be used for in vitro expansion, for tissue engineering / tissue repair and as immunomodulators. The expanded MSC would be used for other four projects of the program by cardiologists, nephrologists, neurologists and for gastrointestinal disease (inflammatory bowel disease). Stem cell research strategy Recently the DBT has evolved a strategy for stem cell research for the country. "We have been able to put a stem cell strategy in place in which both the academia and industry have a role" remarked Dr Bhan. This is considered a significant achievement in the stem cell segment. The main features of strategy are: Research will be promoted for therapeutic applications using adult and embryonic stem cells as well as other more readily available sources such as bone marrow, peripheral blood and umbilical cord blood cells; focus will be on basic research and study of factors that generate stem cells and how stem cells can be stopped from proliferation; study of stem cell biology will also form an important aspect; emphasis will also be on the study of expansion of haematopoietic stem cells without differentiation and gene transduction, gene regulation and plasticity of stem cells; establishing COE will increase productivity in stem cell research in the country. In this regard, interdisciplinary proposals are being developed with the involvement of basic researchers, clinicians and industry. Ethical guidelines The entire area of stem cell research faces ethical and moral dilemma as the rules on what is "ethically correct" varies from one country to the other. The recent Korean stem cell controversy had opened the Pandora's box and revived the debate on this subject. In India there are ethical guidelines on stem cell research, which permit work on therapeutic cloning and are against human reproductive cloning. The relevant regulatory bodies, Indian Council for Medical Research (ICMR) and Department of Biotechnology (DBT) are currently working on these existing guidelines to make it more adaptable for research and use in clinical practice particularly in ophthalmology, cardiology and spinal cord repair. Lucid regulations are considered the need of the hour as Prof K Kannan, founder dean, School of Biotechnology, Guru Gobind Singh Indraprastha University, New Delhi stated, "In India also, a lot of people are under pressure to produce results in this area. They want to go to the clinical trials immediately. People are giving results, which suit them without providing a clear proof. I believe that stem cells are still in the research phase. The regulatory agencies should check whether the claimed benefits are actually due to stem cells or not as there is still no clarity on their mode of action". "In India just like there is a regulatory body monitoring the drug trials, there should be a body looking after the stem cell trials - where data is submitted and a proper protocol and procedure is maintained just like that in drug trials. The need of the hour is to develop an international homogenized protocol in this area", he added. Elaborating on the current status of stem cell regulations in the country, Prof D Balasubramanian, who is chairing the DBT Task Force on Stem Cell Research, said, "The DBT and ICMR have got together and come out with a common set of guidelines and rules, which will be open for public debate and adoption in the next a few months. All institutions doing such work have, in place, the appropriate mandatory ethics committees and institutional review boards, consisting of external experts from science, medicine, ethics, law and sociology. Clinical research workshops to enable clinicians learn the rules of the technology and its applications, are being conducted across the country by the DBT. I think India, in having gone a bit slow and deliberate in the applications of stem cell methods, has done so wisely". Presently a draft policy for stem cell research is under consideration. According to the policy, stem cell research should be promoted in the country in the view of its potential for clinical use. Research based on stem cells derived from adults, bone marrow or foetal cord blood may be undertaken after obtaining appropriate informed consent and with adequate safety measures. For embryonic stem cell research, embryos should not be generated for the sole purpose of obtaining stem cells. Only surplus, spare or supernumerary embryos can be used after obtaining informed consent of both spouses. Such collection of embryos should be done only from registered Assisted Reproductive Technique (ART) clinics. To safeguard national interests, it is also perceived that all human genetic research, stem cell research and stem cell research involving international collaboration must be undertaken after formal clearance of the national government. Consent form for use in collection of tissue to be used in human stem cell research has also been prepared by the National Bioethics Committee. A National Task Force for Stem Cell Research has been established to help develop and facilitate co-ordination. To be competitive within the Asia-Pacific region, the Indian government needs to have a clearly defined set of regulations for stem cell research. Though embryonic stem cell therapy in India is still quite far off, adult stem cell research will reach clinical stages soon. Government commitment, increasing public and private funding and the increasing and well-trained science base in India should all contribute to India's global position strengthening over the coming years. Rolly Dureha with inputs from Narayan Kulkarni Cord blood banking guidelines for India soon India is being sought after for not only its clinical/research expertise but also as a bank of stem cell lines. T he forthcoming stem cell policy of the Indian Council for Medical Research (ICMR) and the Department of Biotechnology (DBT) will also contain guidelines on umbilical cord blood banking facilities. This is in response to the increasing demand for setting umbilical cord blood banks in India. The cord blood cells can be harvested to cure a gamut of malignancies like leukaemia, Hodgkin's disease, different types of anaemia and inherited metabolic disorders. The guidelines will be drafted in consultation with Chennai-based Asia Cryo Cell Private Ltd, whose Lifecell, a joint venture between Asia Cryo Cell and Florida based Cryo-Cell International (CCI), is deemed as the first private stem cell bank in India, and Mumbai-based Reliance Life Sciences. The government had approached both the private bodies for their suggestions some time back. The cord blood banking guidelines would be of international standards and would have specifications for requirements like space, equipment, lab expertise, approval from patient and protocol. India is viewed as an attractive cord blood banking destination because of its largest birth count in the world and its one-billion plus population is genetically diverse enough to match the genetic characteristics of people worldwide. The cord blood is a rich source of stem cells which having the potential to cure serious ailments. The cord stem cell banks process leftover umbilical cord blood from the placenta and umbilical cord after the baby is delivered, and preserves by freezing them in liquid nitrogen at a temperature of -195 degrees celsius. Umbilical cord blood banks can be divided into two categories: private and public. In private banks, one can keep the umbilical cord for two decades, which can be claimed by the family or the patient. Realizing its vast potential, both the public and private groups have been looking at this area with interest. The first cord blood repository in India was established by Reliance Life Sciences (RLS). The company is in the process of setting up its Cord Blood Repository (CBR) and plans to grow the repository to around 30,000 units over the next two-three years. The CBR is part of the cell biology group and has to date, collected, tested and stored the cord blood. RLS is expected to complete the HLA (Human Leukocyte Antigen) typing of the blood in the coming future, which would be followed by animal testing and matching of donor-receiver. The company is then aiming at scaling up its operations - the critical mass being 10,000 stem cell units before the company can join a global network of cord blood repositories. The first strictly private cord blood bank in India is Asia Cryo-Cell Pvt Ltd (ACCPL), an affiliate of the American bank Cryo-Cell International based in Chennai, which began operations in late 2004. In addition, cord blood and bone marrow transplantation has been carried out at leading Indian medical centers for the last 20 years: All India Institute of Medical Sciences (AIIMS), New Delhi; KEM Hospital, Mumbai; Christian Medical College (CMC), Vellore and Indian Institute of Haematology, Mumbai, although these still do not have a dedicated cord blood centre or bank. Recently the Apollo Group of Hospitals has signed a memorandum of understanding (MoU) with the blood bank Histostem Inc to offer stem cell therapy to patients from South Asia. As part of the deal, Histostem India will train doctors and nurses at Apollo for stem cell treatment protocols and develop new treatment protocols with relevant regulatory approval. Meanwhile, a government-sponsored program of public banks was announced in July 2005. The Maharashtra government signed a deal with Histostem to set up a national cord blood bank in Mumbai, with additional centres planned for Delhi, Chennai and Kolkata. The company will be investing close to $20 million to create the facility. Ultimately, these centres will offer regenerative stem cell therapies for spinal cord injuries, brain strokes, diabetes and bone cancer. Looking at increasing number and activity of players in the cord blood banking arena, it is essential to spell out the guidelines clearly for this niche segment. Rolly Dureha Dr Hwang: In the eye of a storm Stem cell controversy tempers hope of patients and researchers Fraudulent research claims have effaced the fledgling stem cell arena After a month of controversy, claims and counter claims it has now been conclusively established that Prof Hwang Woo Suk's work on cloned human embryos and stem cells was fabricated. Seoul National University's (SNU) investigative panel confirmed that Hwang had fabricated data in the article published in Science last year in which he claimed to have produced 11 stem cell lines genetically tailored to patients. The panel has also reported that the scientist's landmark claim of cloning a human embryo and extracting stem cells from it was also a fake. When this study was published in Journal Science in 2004 it was hailed as a path breaking achievement and brought Hwang instant limelight. Now the SNU investigative panel report has stated that there was a high possibility it could have merely been a mutated egg, which could appear to have similar qualities of an embryo. In its final report, the university investigating panel said that Hwang and his research team "did not have any proof to show that cloned embryonic stem cells were ever created." These revelations have stunned the entire scientific community and are a big setback to the research efforts in the stem cell arena. Commenting on this development, Dr K Vijay Raghavan, director of Bangalore-based National Centre for Biological studies (NCBS), one of India's leading basic sciences research centre, which is also involved in stem cell research, said, "The Korean fraud is a major setback for research-not only for stem cells, but research of all kinds. Research in emerging areas is always difficult and any success is welcomed as path breaking and as something to emulate. Thus several groups worldwide were inspired by the Korean experiments and have tried to reproduce them and have wasted valuable time and effort." Indeed, the hopes of patients as well as researchers were buoyed by Hwang's claims but now realizing that cloned stem cells are a long way off, the euphoria created is slowing subsiding. Prof D Balasubramanian, director - research, LV Prasad Eye Institute and chairman, Department of Biotechnology (DBT) Task Force on Stem Cell Research, said, "The work by Hwang Woo-Suk has been rightly criticized from two angles. One is the ethical aspect, where he had forced his coworker to give him her cells. Also, it is not clear how many he had taken and how many he used. Second is the reproducibility of his work. One might have read the warning statement in a recent issue of Science by Dr Ian Wilmut (the creator of Dolly) about the necessity of work of this kind to be repeated and verified independently in another lab. This was not done." But the person in the center of the controversy, Hwang, still maintains that he has the technology to use cloning to create human embryonic stem cells genetically matched to patients and claims that he could do so in six months if he had access to enough human eggs. Hwang's claims had vaulted him on the international center stage as his studies could pave the way for future development of therapies for hard-to-cure diseases. In fact, stem cells have the potential to mature into every cell in the human body. Scientist hope to use stem cells as replacement parts for failing organs and to treat diabetes, Parkinson's and other diseases. Researchers want to harvest stem cells by cloning the DNA of sick people, so they could turn the cells into tissue that genetically matches a patient. That way, the patient wouldn't have to take the anti-rejection drugs used in organ transplants today. Hence any research development in this arena brings a flicker of hope for such patients. Pointing out its impact on the scientific research especially in the Asian region, Prof K Kannan, founder dean, School of Biotechnology, Guru Gobind Singh Indraprastha University, New Delhi, said, "The biggest fallout of this entire episode is the belief that Asian science is going down. This is a big damage to the credibility of scientific research in the Asian region, especially now, when research in this region is actually picking up. This is a sad episode of cheating in the history of science. Now the regulations for accepting research results will be further tightened." But the question remains why did a senior scientist to perpetuate such a big fraud? Did he see this as an easy chance to get fame in a nascent upcoming arena? Where his work would be one of its kind and difficult to validate? Probably! "The scientific community, including the journal needs to share some of this blame, since on a fast-moving topic, with great clinical promise, the need to be the first to publish, and the need to be the first journal to publish the work had become more pressing than scientific rigour and upholding standards of ethics", said Dr Balasubramanian. The Journal Science has since stated that it will formally retract Hwang's two studies and is now considering how to improve safeguards against scientific fraud. "Frauds in any area are a setback to science. In this case it points to the fact, once again, that no matter how fashionable an area one should not be trapped by the pressures of this fashion. There is no moving away from careful and honest science", opined Prof Vijay Raghavan. "Actually there is a lot of hype created around stem cells and it is being touted as a panacea for all diseases, which is not correct", added Prof Kannan. And what will be the impact of one of the biggest scientific frauds of the century on the future of stem cell research? Not much in the long run, say experts. "In the long run this incident will not have a mark and is a temporary passing phase. This is an isolated case, generally scientists do follow ethical guidelines and claim only for what they have solid proof", said Dr Ashok Mukhopadhyay, a senior scientist working in the stem cell arena at the National Institute of Immunology (NII). "I do not think this would affect the progress of embryonic stem cell research per se, though it will slow it down a bit, and certainly sober up all scientists and journal editors. How does this affect the suffering patients? This is a sad question, since the hope built up by Hwang and by the South Korean research agencies will now be tempered, and patients will have to wait longer. This may be actually for the good, in one sense", commented Dr Balasubramanian. Rolly Dureha ]]> <![CDATA["Import the science, but implement it in the local context"]]> https://biospectrumindia.com/news/95/1514/import-the-science-but-implement-it-in-the-local-context.html https://biospectrumindia.com/news/95/1514/import-the-science-but-implement-it-in-the-local-context.html Tue, 17 Jan 2006 12:21:00 +0530 New Page 1 "Import the science, but implement it in the local context" Bala S Manian, Director, ReaMetrix India Pvt Ltd The founding of ReaMetrix marked Bala Manian's reinvolvement with Indian business and technology issues after a more than 30-year hiatus. ReaMetrix is a cutting edge life science company continuing Bala's tradition of high tech solutions to problems with offices in San Carlos, California and Bangalore. It has recently developed Accuford TriTStat assay, a critical diagnostic for managing HIV patients, that could entirely alter the cost paradigm for conducting HIV tests. How different is ReaMetrix in India? ReaMetrix was started with the idea that we were going to use the availability of highly talented people, scientific talent available at a lower cost to do things that can no longer be done in the US. That was the promise with which ReaMetrix was started. In a fairly short period of time, it became clear that the local economic paradigm subconsciously influences every decision that we make. For example, when I am designing a process in the US, subconsciously, I am willing to accept a high material cost to save labor, as labor is more expensive than material in the US. It is just the opposite here in India. We realized that what we really need to do is not simply bring the process over here. Because if we do that, all we do is the saving of the labor cost. But when we actually redesign the process, based on the labor that is available, then we have a more optimal process over here. For example, in the US, I may be willing to accept 15 percent yield by material because the labor that is required to improve that yield is too expensive. Over here, I can use the labor and improve the yield from 15 percent to 40 percent. So we not only get the cost savings on the labor, we also now improve the whole efficiency of the process. The realization is that if we are going to do diagnostics in India, the idea is not to bring the procedures from the US. Just bring the science from the US. Import the science but implement the science in the local context. Our Accuford TriTStat is that first proof of principle of that concept. What is the other differentiation? Generally, one tends to focus on technology providing all the solutions. But what we are doing at ReaMetrix is simply reversing that paradigm. We put the affordability index first. We define affordability of the task as our target and then find the right technology and the right processes that is going to allow us to deliver the goods and services with that kind of affordability index. In a lot of ways, in trying to do the TriTStat test, we set the goal of what it has to cost and then optimize the process to be able to design. What is Accuford TriTStat? The Accuford TriTStat assay has been developed and manufactured by ReaMetrix Corp. as a critical diagnostic for managing HIV patients. The product will be marketed by Millipore India. Our reagent kit provides the consumables for the enumeration of a patient's T-cells on a flow cytometer. The key component of this test are fluorescently-labeled monoclonal antibodies. While the raw materials for the test are imported from established suppliers in developed nations, the process for creating a clinically useful kit is carried out entirely in India. These reagents will identify particular number of subset of cell. If you take one drop of blood, one microlitre, one cubic millimeter of blood, there are 5 million red blood cells in there, approximately 7,100 white blood cells. Out of that 7,100, there are 900 CD4 positive T-cells and 600 CD8 cells. It is the 900 and 600 cells that we are trying to look at. So it is truly looking for a needle in a haystack. And the way you identify them is you take the antibodies that are specific to CD3 and CD4 and you put different colored florochromes on it. And then when it binds to the cell in the flow cytometer, you count the number of events - number of white cells going by and see if it is positive for CD3 and CD4. If it is positive for CD3 and CD4, then it is a T cell - TCD4 cell. So you count them and you report the result as so many cells per microlitre. That is the result we provide. How affordable are your products? Lets take Becton Dickinson (BD) or Beckham Coulter. These are the two major players in this segment. They sell the machines and also the reagents. The reagents are sold at Rs 600- 800 depending on the volume commitment and so on. So the reagents are made in the US. In their case, they add all the value in the US. The raw material that we do is very similar to theirs. So there is no difference between the two, except we add all the value in terms of kit preparation, validation, etc. in Bangalore and we optimize our processes based on the economics over here. And that is the reason why we are able to bring the costs down. We have started supplying the reagents to Anand Diagnostics. It used to charge about Rs 1,200 for this test. It is paying about Rs 700 for the imported reagent from BD. We are supplying the same reagent to it under Rs 150. So we are talking about reducing the price by a factor of five. We had an agreement with it so that it does not pocket the money all by itself. It has reduced the price to the customer to Rs 500. What is interesting is, before our reagents came into the picture, it was doing only about 4-5 tests a day. Now it is doing about 15 tests a day. We want to use this as an example to change the dynamics. In a developed country, somebody may have the test done once every two months and in India right now because the cost is so high, typically they do only two tests a year. There is a companion test or a viral test. Actually we are working on an alternative for that as well. That costs Rs 3,000 to Rs 4,000 and lets say this is Rs 2,000 to do the test. The combination of the two tests is about Rs 5,000 and two tests a year would mean Rs 10,000. Now Cipla sells the whole drug for an entire year for Rs 15,000. So when testing for twice a year is as expensive as the drug itself, it is not fair. What we talking now is reducing the cost immediately. We think a combination of the two tests should be available in the price range of Rs 1,000-1,200. And if you do four tests a year, it will still be Rs 5,000. This is including the viral test. In fact the more tests we put in, the price will come down. Then the other viral load right now costs Rs 2,500. We would like to develop an alternative test to bring that price down as well. So the entire testing burn for managing AIDS patient should really be brought down. That's how we go. So rather than focusing on a menu of tests, we are going to focus on the disease. What are you product expansion plans? We are currently focusing on making the reagents, by optimizing the process by which we produce the reagents. The second step is to modify it in a dry form so that we can deliver it wherever it needs to be delivered without having to worry about the cold chain requirements. The third step is to build our own hardware platform so that we can provide a complete solution. This platform will be a flow cytometer-type platform but based on today's generation of technology. Why have you chosen Millipore as your partner, which is not a diagnostics supplier? Our third philosophy is that we are not going to go and accept either a product concept or a test concept that has been used in the West but rather we want to find out from the market place, what is the right test that is required in the Indian context. Our new ideas are going to come from our customers. So it became clear to us that we cannot just go and find a distribution channel that just sells our products but rather a distribution channel that can own the customer and work with the customer. In India, an existing distribution channel typically has a trading mindset. And that is the reason why ReaMetrix formed this strategic relationship with Millipore India. I'm more interested in the fire under the belly and the gleam in the eye than the past experiences. Why is it called TriTStat? Tri is because we look at three different markets-CD3, CD4 and CD8. You need all of those to get the count of CD4, CD8. And we will report how many cells are CD3 positive, how many cells are CD3 and CD4 positive, how many cells are CD3 and CD8 positive. Right now the largest use is for managing HIV patients. But in general this is used to assess the immune system. There are lots of other diseases in which you want to know the immune system, even in some of the autoimmune diseases. That is why it is called TriTStat. "T" is the T cells that we are talking about. Stat is the status of the T cells. Accuford is the brand name we are establishing which stands for accuracy and affordability. It is affordability without compromising accuracy. Accuford is the brand name, which is really the theme behind what we are doing. Ch. Srinivas Rao and Namratha Jagtap ]]> <![CDATA[ANDHRA PRADESH]]> https://biospectrumindia.com/news/95/1696/andhra-pradesh.html https://biospectrumindia.com/news/95/1696/andhra-pradesh.html Thu, 12 Jan 2006 10:24:00 +0530 DBT Supported ANDHRA PRADESH Al-Ameer College of Engg & IT Gudilova, Anandapura, Visakhapatnam. Anil Neerukonda Institute of Tech & Sciences Sanghivalasa, Bheemunipatnam, Visakhapatnam. Audhishankara College Of Engg & Tech Vindur Panchaya & village, Gudur Mandal, Nellore Dist - 524 101 Bapatla Engineering College Bapatala, Guntur Dist - 522 101 College Of Engineering - Gandhi Institute of Technology & Management Gandhi Nagar, Rushikonda, Visakhapatnam - 530 045. Devineni Venkata Ramana & Dr Hima Sekhar Mic College Of Technology Kachikacherla, Krishna Dist.-521 180 Godavri Institute Of Engineering & Technology NH 5, Chaitanya Nagar, Velugu Bandha (Village), Rajanagaram (M), Chaitanya Nagar, Rajahmundry - 533 294 Gokaraju Ranga Raju Institute Of Engineering & Technology Bachipally Village, Miyapur, Ranga Reddy Dist -500 050. JB Institute Of Engineering & Technology Survey No. 220, Yenkapally Village, Moinabad Mandal, Hyderabad - 500 075 Joginpally BR Engineering College No.220, Moinbad Mandal, Ranga Reddy Dist.- 500 034 KL College Of Engineering Green Fields Kunchanapalli PO, Via Tadapalli, Guntur Dist- 522 501 Madanpalli Institute Of Technology & Science Rishi Valley Cross, Kadiri Road, Kurabalakota Mandal, Madanpalli Taluk - 517 325. Malla Reddy Engg College Survey No. 593, 594, Gundla Pochampally, Medichal Mandal, Hyderabad - 501 401 Narayana Engineering College Narayana Avenue, Opp. Apollo Hospital, NC Factory, Ak Nagar, Nellore 524 004 Padmasri Dr BV Raju Institute of Technology Vishnupur, Narsapur Medak Dist - 502 313 Sree Nidhi Institute of Science & Technology Chintareddy Colony, Tarbind, Old Airport Road, Nacharam, Hyderabad - 500 009, Sri Indu College Of Engineering & Technology Sheriguda (Village), Ibrahimpatnam Mandal, Ranga Reddy Dist. St. Martin's Engg. College Survey No. 98,100, Dulapally, Medchal Mandal, R R Dist.-500 014. TKR College of Engg. & Tech Survey No.8, Medbowli Mirepet, Hyderabad- 500 035 University College Of Engineering Osmania University, Hyderabad - 500 007. Vaagdevi College Of Engineering Bollikunta(P), Near Mamoonoor Camp, C-37,M-24, Warangal - 506 005. TAMIL NADU Avinashlingam Institute For Home Science And Higher Education For Women (Deemed University) Coimbatore - 641 043 Bannariamman Institute of Technology Alathukombai Village, Sathyamangalam - 638 401 National Institute of Technology Tiruchirapalli - 620 015 Pavehdar Bharathidasan College of Engg & Tech Mathur Village (PO), Kullthur Taluk, Pudukkottai Dist - 620 024 Rajiv Gandhi College of Engineering Survey No.103, Nimely Village, Sriperambadur Taluk, Kanchipuram Dist. Sree Sastha Institute of Engineering and Technology Chembarambakkam village, Poonamalla Taluk, Trivellore Dist - 602 107. Udaya School of Engineering Udaya Nagar,Vellamadi Junction, Kanyakumari Dist- 629 204 HARYANA Ambala College of Engg And Applied Research Akbar Pur, P.O.Bihta, Dist. Ambala, Ambala - 133101. Career Institute of Technology & Management Sector 43, Badkhal-Surajkund Road, Faridabad. Guru Jambeswhar University Institute of Engg & Technology Hissar, Haryana PD Memorial College of Engineering Sarai Aurangabad, Bahadurgarh, Jhajjar Dist, Haryana. PUNJAB Guru Nanak Dev University Amritsar. Tel.: 0183-2258431, 2258278 e-mail: prabhjeet_s@yahoo.com Lyallpur Khalsa College Jalandhar City (Punjab). Hindu Mahavidyala Jalandhar City(Punjab). Kanya Mahavidyala Jalandhar City (Punjab). Shaheed Udham Singh College of Engineering and Technology Village: Tangori, Tehsil: Banur, (District: Patiala). Dr Y S Parmar University of Horticulture and Forestry Auni, Distt: Solan, (H.P) Fax: 01792-252242 Punjabi University Patiala â€“ 147 002. University Institute of Engineering and Technology (UIET) Panjab University, Sector-14, Chandigarh. Panjab University Sector-14, Chandigarh. Tel.: 0172-2534088 HP University Summer Hill Shimla (HP) Tel.: 0177-2830775 S D College Sector-32, Chandigarh Rayat Institute of Engineering and Biotechnology Kharar (District Rupnagar). Dept of Plant Breeding, Genetics & Biotechnology Punjab Agricultural University, Ludhiana â€“ 141 004. Fax: 0161-2400945 Govt Girls College Sector-42, Chandigarh. Tel.: 0172-2602741 DAV College Sector-10, Chandigarh Tel.: 0172-2743980 Govt College Sector-11, Chandigarh. Tel.: 0172-2747393 Dr B R Ambedkar National Institute of Technology GT Road By-Pass PO, Nussi, Jalandhar - 144 027. Thapar Institute of Engineering & Technology Patiala RAJASTHAN Jaipur Engineering College & Research Centre Opp. Epip Tank Road, Jaipur. Maharishi Arvind Institute of Engg & Technology Sector7, Madhyam Marg, Mansarovar, Jaipur - 302 012 University of Rajasthan Jawahar Lai Nehru Marg, Jaipur Tel./Fax: 0141-2706813, 2710995/2711799 Website: www.unirai.ernet.in ML Sukhadia University Udaipur Tel./Fax: 0294-2413035/2413150 Website: adm@phynt.mlsu.ac.in, http://education.vsnl.com/mlsu/ Jai Narayan Vyas University Bhagat Ki Kothi , Pali Road, Jodhpur Tel./Fax: 91-291-2649733, 2432947/ 2649733 Website: http://www.jnvu.org Maharishi Dayanand University Ajmer Plant Biotechnology Center Rajasthan Agriculture University, Bikaner Tel./Fax: 91-151-2250689/2250576 Website: dpg@raub.raj.nic.in Rajasthan Agriculture University Directorate of Research (Vet. and Animal Sciences) Bikaner Tel./Fax: 0151-2545359/ 0151-2250336 Website: directorvas@yahoo.co.uk Department of Biosciences & Biotechnology Banasthali Vidyapeeth Banasthali Tel./Fax: 91-1438-228302/ 91-1438-228365 Website: deanbiotech@banasthali.ac.in Birla Institute of Scientific Research Statue Circle, Jaipur Tel./Fax: 91-141-2385238, 5108163/ 91-141-2385121 Website: www.bisrjaipur.com e-mail: research@bisrjaipur.com Central Arid Zone Research Institute Jodhpur www.icar.org.in/ cazri.htmnljoshi@cazri.raj.nic.in Arid Forest Research Institute PO Krishi Upaj Mandi, Basni, Jodhpur Tel./Fax: 0291-2722549/ 0291-2722764 e-mail: director@afri.res.in Central Institute of Arid Horticulture (CIAE) Beechwal, Ganganagar Road, Bikaner Tel./Fax: 0151-2250147 Website: www.icar.org.in/ciah/ciah.htm e-mail: ciah@hub.nic.in Indira Gandhi Centre for Human Ecology, Environmental & Population Studies University of Rajasthan, Jaipur e-mail: heeps@Uniraa.ernet.in Shri Sathya Sal College for Women Jawahar Nagar Byepass, Jaipur Modi Institute of Management & Technology Dadabari Ext., Kota International College for Girls Gurukul Marg, SFS, Mansarover, Jaipur Tel./Fax: 91-141-2395494 Website: www.icfia.org e-mail: icg@icfia.org National College for Girls Vijay Nagar, Alwar Stani Memorial College IRRM Campus Mansarover, Jaipur Mody College of Arts, Science & Commerce Lakshmangarh, Sikar 91-01573-225001-225012 (12 lines)/ 01573-225044 Website: www.modyinst.com e-mail: modycollege@yahoo.com Mahatama Jyoti Rao Phoole Shikshan Sansthan New Sanganer Road, Sodala, Jaipur Tel./Fax: 0141-2294680, 2295101/ 91-141-2292146 Jaipur Engineering College & Research Centre Shri Ram Ki Nangal, Via Vatika, Tonk Road, Jaipur Mahatama Gandhi Instt. Of Applied Science Shri Ram Ki Nangal, Via Vatika, Tonk Road, Jaipur Tel./Fax: 0141-2770274/ 0141-2770803 Institute of Engineering & Technology, Biotechnology MIA, Alwar Tel./Fax: 141-2720560, 2722488 Website: www.ietalwar.com e-mail: ietalwar@ietalwar.com Seedling Academy of Design Technology and Management Khorebariyon, Jagatpura, Tel./Fax: 0141-2753377, 2754399 Website: www.seedlingeducation.com e-mail: ceo.director@seedlingacademy.com Shobhasaria College of Engineering NH-I I Gokulpura, Sikar Tel./Fax: 91-I572-222650-653/ 91-1572-22654 GUJARAT CU Shah College of Engg & Technology Lakhu Pole, Wadhwan City, Surendranagar-363 030 UV Patel Engg College Ganpat Vidyanagar, Kherva Taluk, Mehsana - 384 001 Shree Manibhai & Navalben Virani Science College, "Yogidham", Kalawad Road, Rajkot - 360 005, Tel.: 0281-2563445 Fax: 0281-2563766 Email: biotech_vsc@yahoo.com, viraniscience@hotmail.com Website: www.sks.ac.in Ipcowala Santram Institute of Biotechnology and Emerging Sciences HM Patel English Medium School Complex, Dharmaj Cross Road, Dharmaj - 388430 Tel.: 02697-245551 Email: ilkothari@yahoo.com MADHYA PRADESH Madhav Institute of Technology & Science Gola Ka Mandir, PO Residency, Gwalior - 474 005. Samrat Ashok Tech. Institution Vidisha, MP - 464 001 Shri GS Institute of Technology & Science 23 Park Road, Indore - 453003 Shri Rawatpura Sarkar Institute of Technology Peeli Kothi, Bhawani Vilas Thandi Sadak, Datia - 475 661. Sri Satya Sai Institute of Science & Technology Pachama Taluk Sehore Dist - 466002   ]]> <![CDATA[List of Colleges offering BE Biotechnology]]> https://biospectrumindia.com/news/95/5449/list-of-colleges-offering-be-biotechnology.html https://biospectrumindia.com/news/95/5449/list-of-colleges-offering-be-biotechnology.html Thu, 12 Jan 2006 10:22:00 +0530 KARNATAKA KARNATAKA List of Colleges offering BE Biotechnology Acharya Institute of Technology 1st Cross, 1st stage, Peenya, Bangalore - 560 058 Tel.: (080) 28398699/28398711 Website: www.acharyainstitutions.org Bellary Rural Engineering College 873/2, Bellary Hospet Road, "Jnana Gangotri" Campus, Allipur PO, Bellary â€“ 583 104 Tel.: (08392) 42900/44741 Website: www.becbellary.com BMS College of Engineering Bull Temple Road, Basavanagudi, Bangalore - 560 019 Tel.: (080) 26611586/26615455 Website: www.bmsce.org Basaveshwar Engineering College Nijalingappa Nagar, Bagalkot - 587 102 Tel.: (0835) 420560 Website: www.becbgk.edu BVB College of Engineering Vidyanagar, Hubli - 580 031 Tel.: (0836) 372076 Website: www.bvb.edu Bapuji Institute of Engineering and Technology PB No. 325, Shamanur Road, Davangere - 577 004 Tel.: (08192) 22245/21461 Website: www.bietdvg.edu CMR Institute of Technology 132, Kundalahalli, IT Park Road, Near AECS layout, Bangalore - 560 037 Tel.: (080) 8524466/8524630 Website: www.cmredu.com GMIT PB No. 4, Karur Division, Poona-Bangalore Road, Davangere - 577 006 Tel.: (08192) 33377/33399 Website: www.set-gmit.org KLES College of Engineering and Technology Udymabag, Belgaum - 590 008 Tel.: (0831) 440322 MS Ramaiah Institute of Technology MS R. Nagar Bangalore - 560 054 Tel.: 080-3600822, 3606934 Website: www.msrit.edu MVJ College of Engineering Whitefield, Bangalore - 560 067 Tel.: (080) 28452324/635 Website: www.mvjeducation.com Nagarjuna College of Engineering and Technology No. 38/1, Ramagondanahalli, Yelahanka, Bangalore - 560 064 Tel.: (080) 28564004/02 Website: www.nagarjunaeducation.com New Horizon College of Engineering Kadabhisanahalli, Varthur Hobli Panathur Post, Bangalore - 560 087 Tel.: (080) 28440666/532 Website:www.newhorizonindia.edu NMAM Institute of Technology Udupi - 574 110 Tel.: (08258) 41264/20039 Website: www.nittetrust.org PES Institute of Technology 100 ft Ring Road, BSK III Stage, Bangalore - 560 085 Tel.: (080) 26721983/2108 Website: www.pes.edu PA College of Engineering Kairangala, Mangalore Website: www.paengg.com RV College of Engineering RV Vidyaniketan Post, 12th KM Mysore Road, Bangalore - 560 059 Tel.: (080) 28601701/0184 Website: www.rvce.ac.in Shreedevi Institute of Engineering, Tumkur Sir M Visvesvaraya Institute of Technology Hunasamaranahalli Via Yelahanka, Bangalore - 562 157 Tel.: (080) 28467248/77024 Website: www.sirmvit.edu SJCE Manasagangothri Mysore - 570 006 Tel.: (0821) 512568/511383 Bellary Engg College Survey No. 873, Kolagal village Bellary Hospet Road, Bellary - 583104 Manipal Institute of Technology Manipal - 576 119, Udupi District. Sapthagiri College of Engg 14/5, Chikkasandra, Hesaraghatta Main Road, Bangalore - 560057 Shri BV Sangha's Basaveshwar Engg College Nijalingappa Road, Bagalkot - 587 102 The Oxford College of Engg Bommanahalli, Hosur Road, Bangalore - 560 068 NEW DELHI Netaji Subhash Institute of Technology Azad Hind Fauj Marg, Sector 3, Dwarka, New Delhi - 110 045 MAHARASHTRA Mahatma Gandhi Mission's College of Engg Junction NH 4, Sion-Panvel Express Highway, Kamothe, Navi Mumbai. Shri Vile Parle Kelvani Mandal's College of Engg Plot No. U-15, JVPD Scheme, Bhaktivedanta Swami Marg, Vile Parle (W), Mumbai - 400 056. ORISSA Majhighariani Institute of Tech & Science (MITS) Bhujabal, Kolnara-765001, Rayagada Dist, Orissa - 765001 WEST BENGAL Bengal College of Engg & Tech Bidhannagar, Sector 28, West Bengal - 713 212 Bengal Institute of Technology Bamanghata, on Basanti Highway, Kolkata Haldia Institute of Technology PO Hatiberia, Haldia - 721657 Heritage Institute of Technology Chowbaga Road Anandpur P.O, East Kolkata Township, Kolkata - 700107 Institute of Technology & Marine Engg Vill-Jingha, PO Amira PS Diamond Harbour, 24 Parganas. Netaji Subhash Engg College Techno City, PO Panchpotha, Garia - 743516. Siliguri Institute Of Technology PO Sukhna Siliguri 734225 Dist Darjeeling UTTAR PRADESH Allahabad Agricultural Institute Deemed University Allahabad - 211007, UP, India. Tel.: 0532- 2684281 Fax- +91 5322684394 e-mail: registrar@aaidu.org Babasaheb Bhimrao Ambedkar University Lucknow- U.P Banaras Hindu University Varanasi. Dr Babasaheb Bhimrao Ambedkar University Agra Integral University Dasauli, PO Bas-ha , Kursi Road, Lucknow â€“ 226026 Tel.: 2767162 (R), 2890730, 2890812 (O) Fax: 2890809 e-mail: direngg@integraluniversity.ac.in Lucknow University Lucknow VBS Purvachal University Jaunpur College of Engineering & Technology IILM Academy for Higher Learning Plot Nos. 17 & 18, Knowledge Park, Phase II, Greater Noida,Gautam Budh Nagar Dist. College of Engineering Technology Lodhipur Rajpur Delhi Road, Moradabad. IMS Engineering College National Highway- 24, Delhi-Hapur By-pass Road, Adhyatmik Nagar, Ghaziabad- 201 009. Institute of Engineering & Technology Bundelkhand University, Jhansi-284 001. Meerut Institute of Engineering & Technology Baghpat Road Bypass Crossing, PO Malyana, Meerut - 250 002 Motilal Nehru National Institute of Technology Teliarganj, Allahabad - 211 004. Saroj Institute of Technology Ahmamau, Lucknow-Sultanpur Road, Lucknow. UTTRANCHAL Alpine Institute of Paramedical Sciences Nanda-Ki-Chowki, Premnagar, Dehradun â€“ 248007 Tel.: 0135-2773869, 2771628 Beehive College of Advanced Studies Beehive City, Central Hope Town, Selaqui, Dehradun â€“ 248001 Tel.: 0135-2263711, 2698809 Dr Sushila Tiwari Medical College Haldwani, Dist Nainital Tel.: 05946-282579 Doon PG College of Agriculture Science & Technology Sailaqui Chakrata Road, Dehradun Tel.: 09837039652 G B Pant University of Agricultural & Technology Pantnagar Tel.: 05944-233898 gkgarg@lycos.com HNB Garhwal University Srinagar, Garhwal Tel.: 01370-267427 Indian Institute of Technology Roorkee IIT Roorkee, Roorkee Tel.: 01332-285216 biotech@iitr.ernet.in, rpsbsfbs@iitr.ernet.in Kumaon Engineering College Dwarahat, Almora Dist - 263 653. Kumaun University Nainital Tel.: 05942-235521 e-mail: veena_biotech@rediffmail.com MB Govt PG College Nainital Road, Haldwani - 263139 Tel.: 05946-222017 Sardar Bhagwan Singh PG Institute of Biomedical Sciences & Research Balawala, Dehradun-248161 Tel.: 0135-2685753, 2685756, 2686246 e-mail: info@sbspgi.com Uttaranchal Institute of Technology Lower Mall Road, Almora Tel.: 05962-236266, 236595 Uttaranchal College of Science & Technology Jakhan Johari Road, PO Rajpur, Dehradun Tel.: 0135-2743683 ]]> <![CDATA[List of colleges offering BSc/MSc Biotechnology]]> https://biospectrumindia.com/news/95/3250/list-of-colleges-offering-bsc-msc-biotechnology.html https://biospectrumindia.com/news/95/3250/list-of-colleges-offering-bsc-msc-biotechnology.html Thu, 12 Jan 2006 10:21:00 +0530 KARNATAKA KARNATAKA List of colleges offering BSc/MSc Biotechnology Acharya Institute of Science No. 51, Cholanagar, RT Nagar, Bangalore - 560 032 Tel.: (080) 28398688/28398711 Website:www.acharyainstitutions.org Administrative Management College 4th Block, AMC Building, 30th Cross, Jayanagar, Bangalore - 560011 Tel.: (080) 26638991/92 Website: www.amceducation.org Al-Ameen Arts, Science and Commerce College Hosur Road, Bangalore - 560 027 Tel.: (080) 2222402 Website: www.alameen.edu AM College 6th Main, 30th cross, IV block, Jayanagar, Bangalore - 560 011 Anupama College of Management Studies and Science West of Chord Road, Mahalakshmipuram, Bangalore - 560 086 Tel.: (080)23493096/2560086 Bangalore City College No.13, 10th Cross, Lakshmiya Block, CBI Road, LIC Building, Ganganagar, Banglaore â€“ 560 024 Capital College No. 628/C, 11th Cross, I Stage, Old Madras Road, Bangalore â€“ 560 038 Tel.: (080) 25288831 Website:www.keralasamajam.org Dayananda Sagar College of Management and Information Technology Shavige Malleshwara hills, Kumaraswamy layout, Bangalore - 560 078  Tel.: (080) 26662226 Don Bosco's College of Science and Management 475, 39 C Cross, 9th Main, 5th Block, Jayanagar, Bangalore â€“ 560011 Tel.: (080) 26653248 Dolphin College 215, 39th A Cross, 5th Block, Jayanagar, Bangalore â€“ 560 041 Tel.: (080) 26653248 East West College of Technology 2nd Stage, Rajajinagar, Bangalore â€“ 560 010 Tel.: (080) 23423110/23321270 Website: www.ewit.edu East Point College of Higher Education Bidarahalli Virgonagar Post, Bangalore-560 049 Tel: 080-28473777,28473888 www:epcet.net Garden City College of Management and Science RM Nagar Main Road, Banaswadi, Bangalore - 560 043 Tel.: (080) 25613583/22972744 Website:www.gardencitycollege.edu Ganga Kaveri Institute of Science and Management No. 1709, 1710/28, 80 feet Road, Dr Rajkumar Road, Rajajinagar, Bangalore - 560 010 Tel.: (080) 23429266 Website: www.education.vsnl.com Goutam College 258, 5th Main Road, II Cross, Manjunath Nagar, I Stage, WoC Road, Rajajinagar, Bangalore â€“ 560 010 Tel.: (080) 23303737, 23385300 Website:www.gouthamcollege.org Government Science College Nrupathunga Road, Bangalore - 560 001 Tel.: (080) 22212924 HKES College 2nd cross, Rajmahal Vilas Extension, Sadashivanagar, Bangalore - 560 080 Indian Academy Degree College Hennur Cross, Kalyan Nagar, Bangalore â€“ 560 043 Tel.: (080) 25442370/25444103 Website: www.iadcollege.com KKECS Institute of Management and Computer Science No. 3/2, Ambalipura, Sarjapura Road, Bangalore - 560 037 Tel.: (080) 28439397 Maharani Lakshmi Ammani College for Women 63/5 3rd Main, Malleshwaram Bangalore - 560 003 Tel.: (080) 23349311/23360816 Maharani Science College for Women Palace Road, Bangalore - 560 001 Tel.: (080) 22262796 Mariappa PG College 2992, MKK Road, Mariappanpalya, Rajainagar, Bangalore - 560 021 Miranda Institute of Management Studies HAL III Stage, Indiranagar, Bangalore â€“ 560 075 Tel.: (080) 25253284/25281760 Mount Carmel College 68, Palace Grounds, Vasanthnagar, Bangalore - 560 052 Tel.: (080) 22261759 Website:www.mountcarmelcollegeblr.org MVJ Rajalakshmi College Marathahalli, Banglaore â€“ 560 037 Tel.:(080) 25238619/25233084 Website: www.mvjeducation.com MS Ramaiah College of Arts, Science and Commerce Gokul Post, MSR Nagar, Bangalore â€“ 560 054 Tel.:(080) 23605283/23600319 Website: www.msrit.edu National First Grade College RMV Extension, II stage, 2nd cross, Bhoopasandra, Hebbal post, Bangalore - 560 094 Tel.: (080) 23414557 Website: www.nfgcollege.com NMKRV College for Women III block, Jayanagar, Bangalore - 560 011 Tel.: (080) 26637042 NRI College 6, Papareddypalya, Nagarbhavi, Bangalore - 560 072 NSVK College 27th cross, II stage, Banashankari, Bangalore â€“ 560 070 Tel.: (080) 26719531 Website:www.nsvkeducation.com Presidency College RT Nagar, HMT Layout, Bangalore â€“ 560 032 Tel.: (080) 23636173/23636174/5 Website:www.presidencycollege.com Padmashree Institute of Information Science Nagarabhavi Circle, Bangalore - 72 Tel.: (080) 23212432/23212433 Website: www.padmashree.org PES College 100 ft road, 3rd Stage, HK Halli, Banashankari, Bangalore - 560085 Tel.: (080) 26722882/2652939 Website: www.pes.edu Ramanashree Institute of Management and Science 258, 5th Main, II Cross, Manjunathnagar, Bangalore â€“560010 Tel.:(080) 23303737 Reddy Jana Sangha College III block, 14th Main Road, Koramangala, Bangalore Tel.: (080) 25525534/25534194 Reva Institute of Science and Technology Studies No. 48A, Lakshmaiah Block, 11th Cross, HAF Post, Ganganagar, Near CBI Office, Bangalore â€“ 566 0024 Tel.: (080) 23543830 Website: www.revainstitution.org RK Institute of Management and Computer Science No. 3/2, Ambalipura, Bellanadur Gate, Sarjapur Road, Bangalore â€“ 560 037 Tel.: (080) 28441333 Website: www.rket.org RPA First Grade College CA-2, V block, Rajajinagar, Bangalore - 560 010 SRN Adarsh College 75, Devanathachar Street, 5th Main, Chamarajpet, Bangalore â€“ 560 018 Tel.: (080) 26603573/26526583 Website: www.srnadarshcollege.com Sri Bhagwan Mahaveer Jain College 91/2, Dr AN Krishna Rao Road, VV Puram, Bangalore - 560 004 Tel.: (080) 26614524/26522893, 26615246 Website: www.jaincollege.ac.in Seshadripuram First Grade College Yelahanka new, Bangalore - 560 064 SG Reddy College SGR Towers, 7th Cross Domlur Layout, Bangalore â€“ 560 071 Tel.: (080) 25356111/25356416 SJR College for Women 1/D 59th cross 4th M block, Rajajinagar, Bangalore - 560 010 Tel.: (080) 23359474 SKM Institute of Management and Science 1st Main Road, 1st Block, Vijayanandanagar, Nandini Layout, Bangalore â€“ 560 096 Tel.: (080) 23477157 Website: www.tresha.com/skmet Sri Pragathi Education Society 1, 1st cross, Chowdiah Block, RT Nagar, Bangalore - 560 032 SSMRV College JP Nagar I Phase, Bangalore - 560078 SS Group of Educational Institutions No. 3015, KR Road, BSK II Stage, Bangalore - 560 070 Tel.: (080) 26761570/26761972 Website: www.ssiedu.org SSMRV Degree College 36th Cross, 26th Main, Jayanagar 4 T block, Bangalore - 560 041 St Anne's First Grade College For Women 2 Millers road, Bangalore - 560 052 St George College of Management and Science RM Nagar Main Road, Banaswadi, Bangalore - 560 043 Tel.: (080) 25450193 Website: www.stgeorgecollege.org St Joseph's College Residency road, Bangalore - 560 025 Tel.: (080) 22211429 Website: www.stjosephinstns.com Surana College No. 16, South End Road, Basavanagudi, Bangalore â€“ 560 004 Tel.: (080) 26346141/26642292/26541095 Website:www.suranacollege.com The Oxford College of Science I Phase, JP Nagar, Bangalore - 560078 Tel.:26654415, 26552500-04 Website: www.theoxford.edu T John College 88/2, Kammanahalli, Gottigere, Bannerghatta road, Bangalore - 560 083 Tel.: (080) 28429623-25 Vivekananda Degree College of Arts, Science and Commerce Rajajinagar II stage, Dr Rajkumar road, Bangalore - 560 055 Tel.: (080) 23329511/23320952 VV Puram College of Science VV Puram, Bangalore - 560 004 Tel.: (080) 26675575 Vydehi Institute of Biotech Science No. 82, EPIP Area, Whitefield, Bangalore â€“ 560 066 Tel.: (080) 51157291/51157292 Website: www.vims.ac.in ]]> <![CDATA[Colleges offering BE Biotechnology]]> https://biospectrumindia.com/news/95/2574/colleges-offering-be-biotechnology.html https://biospectrumindia.com/news/95/2574/colleges-offering-be-biotechnology.html Thu, 12 Jan 2006 10:20:00 +0530 TAMIL NADU TAMIL NADU Colleges offering BE Biotechnology Adhiyamaan College of Engineering Dr. MGR Nagar, Hosur Dharmapuri - 635 125 ARJ College of Engineering and Technology Thirumana Kottai Main Road, Edayanatham Village, Mannargudi Taluk, Thiruvarur Arulmigu Kalasalingam College of Engineering Anand Nagar, Krishnan Koil, Virudunagar - 626 190 Tel.: (04563) 89042 Arulmigu Kalasalingam College of Engineering Anandnagar, Krishnankoil Dist -Kamarajar -626 190 Arunai Engineering College Velu Nagar, Thiruvannamalai - 606 603 Tel.: (04175) 36799/37419 Arunai Engineering College, Mathur, Thiruvannamalai Dist: Sambuvarayar - 606 601 Bharathidasan Institute of Engineering & Technology Tiruchirappalli - 624 024 Ph: (0431) 660392 GGR College of Engineering Pillaiyarkuppam, Vellore - 632 009 Jeppiar Engineering College Jeppiar Nagar, Chennai - 600 119 Tel.: (044) 4501644 Kamaraj College of Engineering & Technology Kidarippatti, Madurai - 625 301 Kamaraj College of Engineering and Technology SPGC Nagar, Madurai Road, Virudunagar â€“ 626 001 Tel.: (04549) 278791/278171 Karpaga Vinayaga College of Engineering & Technology Kolambakkam & Moosaivakkam Village. Karpagavinayaga College of Engg and Tech Karpaga Vinayaga Nagar, GST Road, Palayanoor, Madhuranthagam â€“ 603 308 KS Rangasamy College of Technology Thokkavadi, Tiruchengode, Salem - 637 209 Kumaragur College of Technology Chinnavedampatti, Coimbatore -641 006 Kumaraguru College of Technology Chinnavedampatti Post Coimbatore â€“ 641006 Tel: (0422)- 2669401- 05 Madha Engineering College Madha Nagar, Kundrathur, Chennai - 600 069 Tel.: (044) 24780732-34 Maduranthakam Kanchipuram Prathyusha Engineering College Aranavayal - 602 025 Mepco Schlenk Engineering College Amathur, Sivakasi, Dist: Kamajar - 626 005 Mepco Schlenk Engineering College Virudhunagar â€“ 626 005 Tel.: (04562) 230267/289720/289730 Pavehdar Bharathidasan College of Engineering & Technology Mathur Village, Dist: Pudukkottai - 620 024 Periyar Maniammai College of Technology for women Periyar nagar, Vallam, Thanjavur -613 403 Regional Engineering College Tiruchirapalli - 620 015 Periyar Maniammai College of Technology for Women Periyar Nagar, Vallam, Thanjavur â€“ 613 403 Tel.: (04362) 266263 PR Engineering College Vallam, Thanjavur - 613 403 Prathyusha Engineering College Aranvayalkuppam, Poonamallee, Thiruvallur District â€“ 602 025 PSG College of Technology Peelamedu, Coimbatore â€“ 641 004 Tel: (0422) 2572177/2572477 PSR Engineering College Sevalpatti, Sivakasi - 626 140 Tel.: (04562) 439091-95 Rajalakshmi Engineering College Rajalakshmi Nagar, Thandalam, Chennai - 602 105 Tel.: 256640/256750-53 Rajalaxmi Engg College No-69, New Avadi Road, Kapauk, Chennai - 600 010 Tel.: 044-26442472/26461316 Saraswathi Velu College of Engineering Jambukulam Road, Walajah, Sholinghur - 631 102 Shri Andal Alagar College of Engineering No. 6, GST Road, Mamandur Village, Chengelpet â€“ 603 111 Tel.: (04115) 515662/515663 Shri Andal Alagar College of Engineering No.6, Namandur Village, GST Raod, Madhuranthakam Sri Nandhanam College of Engg and Tech Molagarampatti, Tirupattur â€“ 635601 Tel.: (04179) 226292/228892 Sri Nandhanam College of Engineering & Technology Molagarampatti, Tirupattur - 635601 St Joseph's College of Engineering Jeppiaar Nagar, Chennai - 600 119 Tel.: (044) 24501060/ 4501449 St Michael College of Engineering & Technology St Santhiagappar Nagar, Kalayarkoil - 630 551 Tel.: (04575) 32010/32009 St Peter's Engineering College College Road, Avadi, Chennai - 600 054 Vellore Institute of Technology Katpadi â€“Tiruvalam Road, Vellore, North Arcot, Dist Ambedkar - 632 007 Vivekananda College of Engineering for Women Elayampalayam â€“ 637 205 MAHARASHTRA Prominent colleges offering Biotech courses Bharati Vidyapeeth's College of Engineering Sector 7, CBD Belpada, Navi Mumbai - 400 614 Tel.: 022-27572140/27571074 Kohlapur Institute of Technology Gokul Shirgaon, Kolhapur - 416234 Tel.: (0231) 38141, 38143 Vasantdada Sugar Institute Manjari (Bk.), Haveli, Pune - 412 307 Tel.: (020) 6993994, 6993995 Vidya Pratishthan's, School of Biotechnology Vidyanagari, Baramati, Pune â€“ 413133 Tel.: 952112 239385 BTech Biotechnology Colleges offering biotechnology as a subject in Mumbai University Basantsing Inst. of Science 23-24, Backbay Reclamation, 'A' Road, Mumbai - 400 020 Bhavan's College Munshi Nagar, Andheri (W), Mumbai - 400 058 Birla College of Arts Science & Commerce 4 Chandan Apartment, Karnik Road, Kalyan, Thane Tel.: 0250-2314740/2316029 Chauhan Institute of Science Vile Parle (W), Mumbai - 400 056 Guru Nanak College of Arts, Science & Commerce, Guru Tej Bahadur Nagar, Mumbai- 400 037 Guru Nanak Khalsa College King's Circle, Mumbai â€“ 400 019 KB College Mithbunder Road, Kopri, Thane (E) - 603 Kelkar Education Trust's Vinayak Ganesh Vaze College of Arts, Science & Commerce Mithagar Road, Mulund (E), Mumbai â€“ 400 081 Kishinchand Chellaram College Dinshaw Wachha Rd Churchgate, Mumbai - 400 020 KJ Somaiya College Vidyanagar, Vidyavihar, Mumbai - 400 077 National Education Society's Ratnam College National High School Marg, Bhandup, Mumbai - 400 078 Patkar College of Arts & Science SV Road, Goregoan (W) Mumbai â€“ 400 062 Ramnirajan Jhunjhunwala College Opp. Railway Station Ghatkopar (W), Mumbai - 400 086 RD National College Bandra, Mumbai - 400 050 Rizvi College of Arts, Science & Commerce Rizvi Complex, Opp. Carter Road, Sherly Rajan Road, Bandra (W), Mumbai â€“ 400 050 Sheth LU Jhaveri College of Arts & Sir MV College of Science & Commerce, S Radhakrishnan Road Andheri (E), Mumbai - 400 069 SIES College Of Commerce And Economics Plot No.71/72, TV Chidambaran Marg, Sion, Matunga Estate, Mumbai - 400 022 Tel.: 4074944 Sophia College Bhulabhai Desai Rd. Mumbai - 400 026 SP Mandalie's Ramnarain Ruia College Matunga, Mumbai â€“ 400 019 Tel.: 022-4143098/414 3119 Website: www.ruiacollege.edu Vivekanand Education Society's College Sindhi Society, Chembur Mumbai â€“ 400 071 Kelkar Education Trust's Vinayak Ganesh Vaze College of Arts, Science & Commerce Mithagar Road, Mulund East, Mumbai - 400081 Tel.: 022 25681004/25671422 Email: ketvaze@bom3.vsnl.net.in Website: www.vazecollege.net Some other colleges offering biotech courses Center for Distributed Learning IIIT Campus Gachi Bowli, Hyderabad - 500 019 Tel.: (040) 3001969/71 Website: www.msitprogram.net Institute of Engineering and Technology Lucknow â€“ 228 821, Uttar Pradesh Tel.: 9415012030 Course: M-Tech in Biotechnology, PhD Biotech Karpagam Arts & Science College Pollachi Main Road, Eachanari Post, Coimbatore-6411021 Tel.: 0422 - 2611146, 2611082 Course: BSc Biotechnology, MSc Biotechnology T Subbarami Reddy and T Balarama Krishna Degree College and PG Center Mango Grove, Sri Nagar, Gajuwaka, Visakhapatnam - 530 026, Andhra Pradesh Tel.: (0891) 2515 657/2744 ]]> <![CDATA[TAMIL NADU]]> https://biospectrumindia.com/news/95/2320/tamil-nadu.html https://biospectrumindia.com/news/95/2320/tamil-nadu.html Thu, 12 Jan 2006 10:16:00 +0530 TAMIL NADU TAMIL NADU Anna University Sardar Patel Road, Guindy, Chennai - 600 025 Tel.: (044) 22352385/2351126 Website: www.annauniv.edu Avinashilingum Institute for Home Science Coimbatore - 641 043 Tel: (0422) 2438381 Website:www.avinashilingam.edu/ BCG Vaccine Laboratory Guindy, Chennai Tel.: (044) 2342976/2341745 Website: http://mohfw.nic.in/dghs.htm Bharathiar University Maruthamalai Road, Coimbatore - 641 046 Tel.: (0422) 2422222/2422223 Course: MSc Bioinformatics Website: www.b-u.ac.in Bharathidasan University Palkalaiperur, Tiruchirappalli - 620 024 Tel.: (0431) 660392/660271-2 Website: ww.bharathidasan.org Cancer Institute Canal Bank Road, Adyar, Chennai Website: http://www.webhealthcentre.com Centre for Plant Molecular Biology Tamil Nadu Agricultural University, Coimbatore - 641 003 Tel.: (0422) 431222/431821 Website: www.tnau.ac.in Centre for Protein Engineering and Biomedical Research Chennai Voluntary Health Services, Adyar, Chennai - 600 013 Centre for Research in Medical Entomology PO No.11, 4 Sarojini street, Chinna Chokkikulam, Madurai - 625 002 Tel.: (0452) 2650281/2530746 Website: http://icmr.nic.in/pinstitute/crme.htm Entomology Research Institute Loyola College, Chennai - 600 034 Indian Institute of Technology IIT PO, Chennai - 600 036 Tel.: (040) 22351365 Website: www.iitm.ac.in Institute of Brakishwater Aquaculture 141 Marshalls Road, Egmore, Chennai - 600 008 Tel.: (044) 28218216/28218125/28218178 Website:www.dare.nic.in/ciba.htm Madurai Kamaraj University Department of genetic engineering, School of Biotechnology Palkalai Nagar, Madurai - 625 021 Tel.: (0452) 858471-75 Website: www.mkuniversity.org MS Swaminathan Research Foundation 3rd Cross Road, Taramani Institutional Area, CPT Campus, Chennai - 600 113 Website: www.mssrf.org Sathyabama Institute of Science and Technology Old Mamallapuram Road, Jeppiaar Nagar, Chennai - 600 119 Shri AMM Murugappa Chettiar Research Centre Photosynthesis and energy division, Taramani, Chennai - 600113 Website:www.murugappa.com/ SPIC Science Foundation Dept of Biotechnology, 110 Mount Road, Chennai - 600 032 Tel.: (044) 22355662 Website:www.spicscience.org/ Tamil Nadu Veterinary and Animal Sciences University Madhavaram Milk Colony, Chennai - 600 051 Tel.: (044) 25551586/25551587 Website: www.tanuvas.com Tuberculosis Research Centre Mayor VR Ramanathan Road Chetput, Chennai - 600 031 Tel: (044) 28362432/28362433 Website: http://icmr.nic.in University of Madras Centenary Building Chepauk, Triplicane PO, Chennai - 600 005 Tel.: (044) 25368778 Vector Control Research Centre Medical complex, Indira Nagar, Pondicherry - 605 006 Tel.: (0413) 2272396 Website: http://icmr.nic.in Vellore Institute of Technology Ranipet - Katpadi Road, Vellore - 632 014 Tel.: (0416) 243091/245070 Website: www.vit.ac.in Colleges offering Biotechnology DELHI & NCR Amity Institute of Biotechnology Sector - 125 Noida (Adjoining New Delhi) Tel: 0120-2432400 Website: www.amity.edu/aib Asia Pacific Institute of Management Sarita Vihar, New Delhi - 110 044 Tel.: (011) 26947838/26951542 Website: www.asiapacific.edu/ BioInformatics Institute of India B-15, Sector - 3, Noida - 201 301 Tel.: 2442815/2816/2518421 Website: www.bioinformaticscentre.org DOEACC Electronics Niketan, 6,CGO Complex, New Delhi - 110 003 Tel.: 24364870 Website: www.doeacc.org.in JayPee Institute A-10, Sector-62, Noida - 201307 Tel.: (0120) 2400973-976 Website: www.jiitindia.org/jiit/ STG International Ltd 176, Gautam Nagar, Gurgaon - 110049 Tel.: (0124) 5100251-253 Website: www.stgglobal.com HIMACHAL PRADESH CSK HP Krishi Vishava Vidyalaya (HPKV) Palampur Dr YS Parmar University of Horticulture and Forestry (UHF) Solan Himachal Pradesh University (HPU) Shimla Jaypee University of Information Technology (JPUIT) Waknaghat, Solan National Institute of Technology (NIT) (Deemed University) Hamirpur, HP KERALA Colleges offering BE Biotechnology MET's School of Engineering Kuruvillassery, Mala, Thrissur - 680 735 Tel.: (0488) 890672 Model Engg College BMCPO, Thrikkakara, Ernakulam - 682 021 Mohandas College of Engineering and Technology Anad Village, Nedumangad, Thiruvananthapuram - 695 003 Tel.: (0472) 311332/310699 Sahrdaya College of Science and Technology Kodakara, Thrissur - 680 7684 Tel.: (0488) 726630/31 Shri Chithira Tirunal College of Engineering Pappanamcode, Thiruvananthapuram - 695 018 Tel.: (0471) 2490572 Sree Budha College of Engineering Pattor, Padanilam, Noornad, Alapuzha - 690 529 Tel.: (0479) 388080/81/82 Udaya School of Engineering Udaya Nagar, Vellamadi Junction, Kanyakumari â€“ 629 204 ]]> <![CDATA[Important Research Institutes and Universities offering Biotechnology Courses]]> https://biospectrumindia.com/news/95/8353/important-research-institutes-and-universities-offering-biotechnology-courses.html https://biospectrumindia.com/news/95/8353/important-research-institutes-and-universities-offering-biotechnology-courses.html Thu, 12 Jan 2006 10:15:00 +0530 Important Research Institutes and Universities offering Biotechnology Courses Important Research Institutes and Universities offering Biotechnology Courses ANDHRA PRADESH Acharya NG Ranga Agricultural University Rajendranagar, Hyderabad - 500 030 Tel.: (040) 24015161 Website: www.angrau.net Andhra University Waltair, Visakhapatnam - 530 003, Andhra Pradesh Tel.: (0891) 555547 Center for DNA Fingerprinting and Diagnostics Laboratory Hyderabad - 500 076 Tel: (040) 7155481 Website: www.cdfd.org.in Central Research Institute for Dryland Agriculture Hyderabad - 500 659 Tel: (040) 24530177/24530161 Website: www.dryland.ap.nic.in Central Tobacco Research Institute Rajahmundry - 533 105 Tel: (040) 2465995/2471871 Directorate of Oilseed Research Rajendranagar, Hyderabad - 500 030 Tel: (040) 24015344 Website: www.dor-icar.org Directorate of Rice Research Rajendranagar, Hyderabad - 500 030 Tel.: (040) 4015036-39 Website: http://dare.nic.in/drr.htm Jawaharlal Nehru Technological University Kulkatpally, Hyderabad - 500 072 Tel.: (040) 3158661-4 Website: www.jntu.ac.in Kakatiya University Vidyaranyapuri, Warangal - 506 009 Tel.: (08712) 38001/77101-03 Website: www.kuwarangal.com National Institute of Nutrition Jamai-Osmania PO, Hyderabad - 500 007 Tel.: (040) 2868909 Website: www.icmr.nic.in Osmania University Administrative bldg, Hyderabad - 500 007 Tel.: (040) 27098048/27098088 Website: www.osmania.ac.in/ Sri Krishnadevaraya University Sri Venkateshwarapuram, Anantapur - 515 003 Tel.: (08554) 255231/255294 Website: www.skuniv.ap.nic.in Sri Venkateswara University Tirupati, Chittor - 517 502 Tel.: (08574) 49727/49666 Website: www.svuni.ap.nic.in University of Health Sciences Vijayawada - 520 008 Tel.: (0866) 477206-10 ASSAM Guwahati University PO Gopinath Bordoloi Nagar, Guwahati 781014 Tel.: +91-361-671152, 671220 Website: www.gu.nic.in Tezpur University Napaam - 784028 Tezpur, Assam, Tel.: +91-3712-267007 / 8 / 9 Fax: +91-3712-267006 Assam Agricultural University Jorhat - 785 013 Tel.: (0376) 340097 Website: www.aau.ac.in Indian Institute of Technology Institution of Engineers Building, Panbazaar, Guwahati - 781 001 Tel.: (0361) 790321-8 Website: www.iitg.ernet.in BIHAR LN Mithila University Kameshwarnagar, Darbhanga - 846 008 Tel.: (06272) 22428/22463 Indian Institute of Bio-Informatics &Bio-Technology Dr. Zakir Husain Institute Bailey Road, Patna-800001 Tel.: 2220647/ 2222919/ 9835020036 Email: uksingh@uttamonline.com Patna University Patna - 800 005 Tel.: (0612) 670531 CHATTISGARH Guru Ghasidas University PO Koni, Bilaspur - 495 009, Chhatisgarh Tel.: (07752) 40784/72549 MATS University Raipur Chhattisagarh Pandit Ravishankar Shukla University Raipur-492 010, Chhattisgarh Ph: (0771) 262540 Website: www.rsuniversity.com RAI University Raipur Chhattisgarh St Thomas College Bhilai, Chhattisgarh Affiliated to Pt. Ravi Shankar Shukla University DELHI All India Institute of Medical Sciences Ansari Nagar, New Delhi - 110 029 Tel.: (011) 26588500/26588700/26589900 Website: http://www.aiims.ac.in Guru Gobind Singh Indraprastha University Kashmere Gate, Delhi - 110 006 Tel.: (011) 2969313/3863536 Website: www.ggsipu.nic.in Indian Agriculture Research Institute New Delhi â€“ 110 012 Tel.: (011) 25843375/25853367 Website: www.iari.res.in Indian Institute of Technology Hauz Khas, New Delhi - 110 016 Tel.: (011) 26967696/26861977 Website: www.iitd.ernet.in International Centre for Genetic Engineering and Biotechnology New Delhi Tel.: (011) 26189358 Website: www.icgeb.res.in Jamia Hamdard Hamdard Nagar, New Delhi -110 062 Tel.: (011) 26084685/26089688 Website: www.jamiahamdard.edu Jamia Millia Islamia Mohammad Ali Jauhar Marg, Jamia Nagar, New Delhi - 110 025 Tel.: (011) 26831717/26835176/26835315 Website: www.jmi.nic.in National Brain Research Centre New Delhi Tel.: (0124) 2338922-26 Website: http://www.nbrc.ac.in/ National Bureau of Plant Genetic Resources New Delhi - 110 012 Tel.: (011) 25843697 Website: www.icar.org.in National Centre of Plant Genome Research New Delhi Website: http://dbtindia.nic.in/institutions/ncpgr.html National Institute of Communicable Diseases New Delhi Website: http://mohfw.nic.in/kk/95/ib/95ib0k01.htm National Institute of Immunology Aruna Asif Ali Marg, New Delhi - 110 067 Tel.: (011) 26105001 Website: www.nii.res.in Rai University A-41, MCIE, Mathura Road, New Delhi - 110 044 Tel.: (011) 51560000/51570000/26959000 Course: BSc Biotechnology, MSc Biotechnology, MSc Bioinformatics Website: www.raiuniversity.edu HARYANA Kurukshetra University Kurukshetra -136 119 Tel.: (01744) 238039/238417 Website: www.kuk.ernet.in National Dairy Research Institute Karnal - 132 001 Tel.: (0184) 2252800/2259002 Website: http://karnal.nic.in/res_ndri.asp HIMACHAL PRADESH Central Research Institute Kasauli Website: http://mohfw.nic.in/kk/95/ib/95ib0q01.htm Institute of Himalayan Bioresource Technology (IHBT) Palampur Central Potato Research Institute (CPRI) Shimla National Research Centre for Mushroom (NRCM) Solan, HP JHARKHAND Birsa Agricultural University Kanke, Ranchi - 834 006 Tel.: (0651) 455073/455850 Website: www.icar.org.in/birsa/BAU.htm KARNATAKA Bangalore University Jnana Bharathi, Bangalore - 560 056 Tel.: (080) 22211792 Center for Human Genetics Bangalore - 560 066 Specialization: Genome research Indian Institute of Horticultural Research Bangalore - 560 080 Website: http://www.iasri.res.in/inaris/iihr.html Indian Institute of Science Bangalore - 560 012 Tel.: (080) 23601219/23600416 Website: www.iisc.ernet.in Jawaharlal Nehru Centre for Advanced Scientific Research Jakkur, Bangalore - 560 064 Tel.: (080) 8462750-57 Website: http://www.jncasr.ac.in/contact.html Karnatak University Pavate Nagar, Dharwad - 580 003 Tel.: (0836) 2448600 Website: www.nitpu3.kar.nic.in Karnataka State Sericulture Development Institute Thalaghttapura, Banglore - 560 002 Manipal Academy of Higher Education University Building, Madhav Nagar, Manipal - 576 119 Tel.: (08252) 2571201 Website: www.manipal.edu National Institute of Mental Health and Neuro Sciences PB No. 2900, Bangalore - 560 029 Tel.: (080) 26564140/26561811 Website: http://www.nimhans.kar.nic.in/ University of Agricultural Sciences Gandhi Krishi Vignana Kendra Campus, Bangalore - 560 065 Tel.: (080) 23330153-62 Website: www.uasbng.kar.nic.in KASHMIR University of Kashmir Srinagar - 190 006, Jammu & Kashmir Tel.: (0194) 429405 KERALA Central Institute of Fisheries Technology Willingdon Island, Matysapuri, Cochin - 682 029 Website:www.indian-ocean.org Central Plantation Crop Research Institute Kasaragod-671 124 Tel.: (04994) 232894-6 Website: http://cpcri.nic.in Central Tuber Crops Research Institute Thiruvananthapuram - 695 017 Tel.: (0471) 2598551 Website: http://www.ctcri.org/ Indian Institute of Spice Research Calicut - 673 012 Tel.: (0495) 2731346 Website: http://www.iisr.org/ Marine Products Export Development Authority MG Road, Cochin - 682 016 Tel.: (0484) 311979/311803 Website:www.mpeda.com/ Rajiv Gandhi Centre for Biotechnology Thiruvananthapuram - 695 014 Tel.: (0471) 2341716/2347975 Website: http://www.rgcb.res.in/ Sentinel Surveillance Center for Tuberculosis 130, Kerala Agricultural University, Trichur â€“ 680 654 University of Kerala University PO, Thiruvananthapuram - 695 034 Tel.: (0471) 306634/305726 Website: ww.keralauniversity.edu MADHYA PRADESH Awadesh Pratap Singh University Rewa - 486 003 Tel.: (07662) 51519/50050 Barkatullah Vishwavidyalaya Hoshangabad Road, Bhopal - 462026 Tel.: (0755) 587236/290671 Doctor Harisingh Gour Vishwavidyalaya Gour Nagar, Sagar - 470 003 Tel.: (07582) 22574/22475 Jiwaji University Vidya Vihar, Gwalior - 474 001 Tel.: (0751) 341896/341348 Website: www.jiwaji.edu MAHARASHTRA Agharkar Research Institute Gopal Ganesh Agarkar Road, Pune - 411 004 Tel.: (020) 2654357/25653680 Website:www.aripune.org/ Amravati University Tapowan Road Camp, Amravati - 444 602 Tel.: (0721) 662373/662206-8 Website: www.amtuni.com Bhabha Atomic Research Center Trombay, Mumbai - 400 085 Tel.: (022) 25505050/25505010 Website:www.barc.ernet.in/ Cancer Research Institute Tata Memorial Center, Parel, Mumbai - 400 012 Tel.: (022) 24123803 Website: http://icmr.nic.in/cancer.pdf Dr BR Ambedkar Marathwada University University Campus, Aurangabad - 431 004 Tel.: 334431-37 Indian Institute of Technology Powai, Mumbai - 400 076 Tel.: (022) 25767771 Course: MSc Biotechnology Website: www.iitb.ernet.in Institute of Chemical Technology Mumbai University, Nathalal Parikh Marg, Matunga, Mumbai - 400019 Tel.: (022) 24145616 Website:www.udct.org/info National AIDS Research Institute 73, G-block, MIDC, Bhosari, Pune - 411 026 Tel.: (020) 27121072 Website: http://icmr.nic.in/pinstitute/nari.htm National Center for Cell Science University of Pune Campus, Ganesh Khund, Pune - 411 007 Tel.: (020) 25690922/25690931 Website:www.nccs.res.in/ National Institute of Virology 20A, Dr Ambedkar Road, Pune - 411 001 Tel .: (020) 6127301 Website:www/icmr.nic.in/niv.htm North Maharashtra University PO No. 80, NH No.6, ITI Hostel, Jalgaon - 425 002 Tel.: 252187-90 Website: www.nmu.ac.in Pune University Pune - 411 007 Tel.: (020) 25692039/25690195 Course: MSc Bioinformatics, MBA Biotechnology Website: www.unipune.ernet.in Serum Institute of India 212/2, Hadapsar, Off Soli Poonawalla Road, Pune - 411 028 Website: www.seruminstitute.com Tata Institute of Fundamental Research Homi Bhabha Road, Mumbai - 400 005 Tel.: (022) 22804545 Website: http://www.tifr.res.in/ University of Mumbai Department of Biotechnology, Vidyanagari, Santacruz (E), Mumbai - 400 098 Tel.: (022) 26526053/26528822 Vasantdada Sugar Institute Manjari (Bk) Tal Haveli, Pune - 412 307 Tel.: (020) 26993994 NORTH EAST North-Eastern Hill University Shillong, Meghalaya - 793022 ORISSA Central Institute of Fresh Water Aquaculture Kausalyaganga, Bhubaneswar - 751 002 RAJASTHAN Banasthali Vidyapith PO Banasathali Vidyapith - 304 022 Tel.: (01438) 28341/28348 Website: www.banasthali.org Birla Institute Of Technology And Science Vidya Vihar, Pilani - 333 031 Tel.: (0159) 7642090/7642497 Website: www.bits-pilani.ac.in ]]> <![CDATA[DBT Supported]]> https://biospectrumindia.com/news/95/1028/dbt-supported.html https://biospectrumindia.com/news/95/1028/dbt-supported.html Thu, 12 Jan 2006 10:12:00 +0530 DBT Supported DBT Supported Universities covered under the Combined Biotechnology Entrance Exam conducted by Jawaharlal Nehru University for admission to the DBT supported postgraduate biotechnology training program MSc Biotechnology University of Allahabad Allahabad - 211 002, Uttar Pradesh Tel.: (0532) 465462 Website: www.allduniv.edu Annamalai University Annamalainagar, Cuddalore District - 608 002, Tamil Nadu Tel.: (04144) 38259/38283 Website: www.annamalaiuniversity.ac.in Banaras Hindu University Varanasi - 221 005 Tel.: (0542) 2316558/2368938 Website: www.bhu.ac.in Calicut University Thenhipalam, Mallapuram District, Kozhikode - 673 635, Kerala Tel.: (0495) 2413222/2410071/2414984 Website: www.unical.ac.in Devi Ahilya Vishwavidyalaya Nalanda Parisar, 169 Ravindranath Tagore Marg, Indore - 452 001, Madhya Pradesh Tel.: (0731) 2527532 Website: www.dauniv.ac.in Goa University Sub PO Goa University, Santacruz, Taleigao Plateau - 403 206, Goa Tel.: (0832) 451375-76 Website: www.goauniversity.org Gujarat University Navrangpura, Ahmedabad - 380 009, Gujarat Tel.: (0 79) 6301341/6300342 Website: www.gujaratuniversity.org.in Gulbarga University 'Jnana Ganga', Gulbarga - 585 106, Karnataka Tel.: (08472) 445446 Website: www.gulbargauniversity.kar.nic.in Guru Jambheshwar University Hisar - 125 001, Haryana Tel.: 76025/75459/75015 Website: www.gju.ernet.in Guru Nanak Dev University Amritsar -143 005, Punjab Tel.: (0183) 258802-09 Website: www.gnduonline.org Himachal Pradesh University Summer Hill, Shimla - 171 005, Himachal Pradesh Tel.: (0177) 2831363 Website: hpuniv.nic.in Hyderabad University Hyderabad - 500 134 Tel.: (040) 23010500 Website: www.uohyd.ernet.in Jammu University Baba Saheb Ambedkar road, Jammu Tawi - 180 004, Jammu & Kashmir Tel.: (0191) 48021 Website: www.jammuvarsity.org Jawaharlal Nehru University New Mehrauli Road, New Delhi - 110 067 Tel.: (011) 226162016/226185489 Website: www.jnu.ac.in Kumaun University Nainital - 263 001, Uttranchal Tel.: (05942) 35563/35068 Lucknow University Badshah Bagh, Lucknow - 226 007, Uttar Pradesh Tel.: (0522) 330065/322761 Website: www.lkouniv.ac.in MS University of Baroda Fatehganj, Vadodara 390 002, Baroda Tel.: 795600 Website: www.msub.edu Madurai Kamaraj University Palkalai Nagar, Madurai - 625 021, Tamil Nadu Tel.: (0452) 2858471-75 Website: www.mkuniversity.org Mysore University Crawford Hall, Mysore - 570 005, Karnataka Tel.: (0821) 2420161/2420677 Website: www.universityofmysore.org Nagpur University Ravindra Nath Tagore Marg, Nagpur - 440 001, Maharashtra Tel.: (0712) 523045/525417 North Bengal University Raja Rammohunpur PO, Darjeeling - 734 430, West Bengal Website: www.nbu.ac.in Punjab University Sector 14, Chandigarh -160 014, Punjab Tel.: (0172) 541945 Website: www.puchd.ac.in Pondichery University R Venkataraman Nagar, Kalapet, Pondicherry - 605 014 Tel.: (0413) 655991-998 Website: www.pondiuni.org Pune University Ganeshkhind, Pune - 411 007, Maharashtra Tel.: (020) 5496061/5690062 Website: www.unipune.ernet.in Punjabi University Patiala - 147 002, Punjab Website: www.universitypunjabi.org Sardar Patel University Vallabh Vidyanagar, Vidyanagar - 388 120, Gujarat Tel.: (02692) 31122/36545 Website: www.spuvvn.edu Tezpur University Napaam, Tezpur - 784 028, Assam Tel.: (03712) 670004/670007 Website: www.tezu.ernet.in Thapar Institute of Engineering and Technology Patiala - 147 001, Punjab Tel.: (0175) 365228 Website: www.tiet.ac.in Utkal University PO Vani Vihar, Bhubaneswar -751 004, Orissa Tel.: (0674) 580729/580735-36 Website: www.utkaluniversity.org MSc (Agri) Biotechnology Ch. Sarwan Kumar HP Krishi Vishwavidyalaya Palampur District, Kangra - 176 062, Himachal Pradesh Tel.: (01894) 30521/30383 GB University of Agriculture and Technology Pantnagar, Udham Singh Nagar - 263 145, Uttaranchal Tel.: (05944) 33640 Website: www.gbpuat.ac.in Indira Gandhi Agricultural University Krishak Nagar - 492 012, Raipur, Chhattisgarh Tel.: (0771) 424481/424666 Marathwada Agricultural University Krishi Nagar, Parbhani - 431 402, Maharashtra Tel.: (02452) 23801-805 Orissa University of Agriculture and Technology Khurda, Bhubaneswar - 751 003, Orissa Tel.: (0674) 402868/402919 Website: www.ouat.ac.in Tamil Nadu Agricultural University Coimbatore - 641 003, Tamil Nadu Tel.: (0422) 431222/431821 Website: www.tnau.ac.in MVSc Biotechnology GB Pant University of Agriculture and Technology Pantnagar, Udham Singh Nagar - 263 145, Uttaranchal Tel.: (05944) 33640 Website: www.gbpuat.ac.in MTech (Biotechnology) Anna University Sardar Patel Road, Guindy, Chennai - 600 025, Tamil Nadu Tel.: (044) 22352385/2351126 Website: www.annauniv.edu West Bengal University of Technology West Bengal State Archives Buildings, 43, Shakesphere Sarani, Kolkata-700 017, West Bengal Tel.: (033) 22811907-1908 Website: www.wbut.net ]]> <![CDATA["Biozeen can be considered as a polytechnic of industrial biotech."]]> https://biospectrumindia.com/news/95/1350/biozeen-can-be-considered-as-a-polytechnic-of-industrial-biotech-.html https://biospectrumindia.com/news/95/1350/biozeen-can-be-considered-as-a-polytechnic-of-industrial-biotech-.html Wed, 11 Jan 2006 17:07:00 +0530 New Page 1 "Biozeen can be considered as a polytechnic of industrial biotech." Dr Anil Paul Kariath, president, training and consulting, founder director, Biozeen Bangalore-based Biozeen was started by people from industry with the mission to bridge the gap between the industry and academia. The founder director of Biozeen, Dr AP Kariath was the head of Sartorius India. As president, training and consulting, Dr Kariath wants to build Biozeen as an institute that will create a base of professionals that will be useful to the industry. Dr Kariath elaborates on Biozeen's activities and courses. Why was Biozeen started? There is a shortage of professionals in the industry, despite the fact that a lot of students, almost 300-400 per college, pass out every year. The problem is that the industry does not find them to be useful to it. The industry is confronted with the issue of availability of suitable candidates. You will notice that the attrition rate as well as the price to acquire the right candidate is very high in this sector. Consequently, several companies had to either abandon their research projects or go slow as many of the people heading such activities have been changing jobs. The best way to handle this situation is by building a loyalty factor. I believe freshers have the right attitude and energy and they can be molded. However, they do not get the break and, if they get, they are to be trained by coworkers. So an institute, which can train people in an environment close to that in the actual manufacturing set-up and provide hands-on training of the usage of the facilities, will help the industry. And that is what we are attempting. Biozeen was started to bridge this gap between the industry requirement and the supply. Why have you decided to focus on biotech education? Most engineering companies have their own training sessions to mould fresh students into their own line of activities. But the biotech sector being small, spread out, and tight on budgets, cannot have their own programs at this point of time. Biozeen can be considered as a polytechnic of industrial biotech. Eventually, there should be similar polytechnics in every cluster. What are your offerings? At the moment we will offer hands-on training, consultancy services, and later look at incubation too. In terms of training, we will provide a modular course. This will be modular in nature and candidates (students and even industry personnel) can join any module. All modules will be run every month. We will also offer a fulltime 12-month (12 modules) course. The courses will start in April 2006. Our training would be in the area of biopharmaceutical production. We have set up a full-fledged mammalian cell culture and microbial fermentation plant with both upstream and down stream facilities. It has a seed production lab, media production facility, bioreactor, fermentor, purification, and glassware preparation units. The facility is closer to CGMP-complaint design plant. In the second phase, we will expand the facility to allow pilot scale production too. We are also setting up a 100-room hostel inside the campus. What is the size of your faculty, the course fee, and the selection criteria? We have 32 faculty members and we will have a strong industry interface. We will take 50 students per batch for the full time course. There will be two batches per year. The course is designed in such a way that the first batch spends the first six months in the classroom and the next six months in the labs. The full time course (all the 12 modules) would cost around Rs 3-3.5 lakh. The fee of a single module will be between Rs 25,000 and Rs 1 lakh depending on the subject. The selection for the full time course will be through an entrance test, which will be announced in January. We do not guarantee the students a job. But our company it self will absorb the first eight batches for our consulting business. And we are confident the industry will be able to absorb our students. Contact Details: Biozeen, Bangalore Biotech Labs Pvt. Ltd. # 49/2, Gubbi Cross, Off Hennur Cross Hennur-Bagalur Road, Kothanur Bangalore - 560 077 Tel.: +91-80-55309006/009 E-mail: biotrain@biozeen.com ]]> <![CDATA[Industry-oriented education needed]]> https://biospectrumindia.com/news/95/1817/industry-oriented-education-needed.html https://biospectrumindia.com/news/95/1817/industry-oriented-education-needed.html Wed, 11 Jan 2006 17:04:00 +0530 Industry Industry-oriented education needed The Association of Biotechnology Led Enterprises (ABLE) organized its first Bio-HR meet on November 26, 2005 at Garden City College, Bangalore as an initiative to bring together the academia and industry to assess the human resource requirements of the biotech industry. While the industry speakers put across their concerns on the quality and number of biotech students graduating from colleges, the academicians were equally vocal and defensive on their honest efforts in bringing up their students to meet the industry's needs. However, one point which all agreed upon was that a sound understanding of the basic principles of science was absolutely required in the aspirants. Prof. MS Thimmappa, vice-chancellor, Bangalore University, who delivered the keynote address, stressed on the need to make professional courses more productive. He felt that universities were now focused on producing a large number of graduates rather than delivering what the industry needs. "Goals have to be set in professional courses by involving parents, students, politicians, bureaucrats, the industry and the university. I look forward to a model of industry-academia partnership giving universities the freedom to set small goals in line with industrial goals," he added. Dr Balaveera Reddy, vice-chancellor, VTU, felt it was important to train students in line with the industrial requirements and support from the industry in this direction was the need of the hour. "This will support the students to be readily acceptable by the industry," he added. Underlining the strong need to train students to develop entrepreneurship abilities, he said the emphasis should be on relevant technical skills and soft skills. Stating that inquisitiveness was the primary requisite of science education, Dr S Anand Kumar, director and head, Astra Zeneca Research Foundation, lamented that the element of questioning, experimenting and discussing was missing in education. "Students today should be able to pilot plans and maintain them or design them as science continuously brings in new ideas which should be converted into technology," he stressed. Commenting on the industry-academia relationship, Dr Mittur N Jagadish, director, Monsanto Research Centre, said, "While academia is in pursuit of basic science, industry is in pursuit of applied science that is involved in developing a product. The mindsets have to come together in a very blendful manner and only then can we produce wonderful products", he said, stressing on the importance of teamwork. Elaborating further, Dr Mittur said, "The concept of genes and DNA as a genetic material can be applied in four major areas-agriculture and food; health, drug and vaccines; environment; and energy. Biotechnology is a mixture of biophysical sciences, engineering/technology, computer science, biological sciences, biochemical sciences and statistics/mathematics." Speaking on bioinformatics, Dr Prashanth Naik said it was a growing field and was important to the pharmaceuticals industry, the agricultural industry and other biotech industries. Dr Anand felt, "It is very difficult to initiate people having vast knowledge across various disciplines. Therefore it becomes mandatory to be an expert in one field than contribute to a gamut of several disciplines. So if a person is well trained in one of these disciplines, then we can definitely become a team player and if there is a bioinformatics course as a discipline, there can be a lot of contribution". Dr Gautam Nadig, director, Metahelix rued that education had been turned into a business. "We need to have good teachers with adequate qualifications and not teachers with simple BScs. We need competent teachers. There is a lack of sufficient incentives for the teachers," he said. "Colleges have to set up high standards for research jobs, academics or industrial works. The industry requires six-eight months to orient candidates but this initiative of orientation should be taken up by colleges themselves," he added. Dr Joseph VG, chairman, Garden City Education Trust and Mahrooq Engineer of Quintiles were among the various academicians and industry leaders present at the interactive meet. ]]> <![CDATA[Jawaharlal Nehru University, Center for Biotechnology, Delhi]]> https://biospectrumindia.com/news/95/6052/jawaharlal-nehru-university-center-for-biotechnology-delhi.html https://biospectrumindia.com/news/95/6052/jawaharlal-nehru-university-center-for-biotechnology-delhi.html Wed, 11 Jan 2006 17:01:00 +0530 1 1 Jawaharlal Nehru University, Center for Biotechnology, Delhi Near Mehrauli Road, New Delhi - 110 067 Tel.: +91-11-26704079/26717040 Website: http://www.jnu.ac.in/ The Center of Biotechnology (CBT) at JNU undoubtedly runs one of the finest masters degree programs in biotechnology. The CBT was established in 1985 under joint sponsorship of the UGC and the DBT. And in the same year the Master of Science program in Biotechnology was started. The Center has established a very successful MSc biotech program, which selects the best of the students from the merit list prepared on the basis of an All India Entrance Test conducted by JNU. Analysis of the merit list indicates that during the past five years about 50-60 percent of the students from the top 100 give their first preference to JNU. But only 20-25 students are taken every year from the top on the basis of their preference. Till now most of the MSc students have gone to do research in different institutions in the country and abroad. Very few students have taken up jobs in the industry. Though the biotech industry is very keen to give jobs to the students and campus placements camps have been organized by various top notch companies like Panacea Biotec, Reliance Life Sciences and Invitrogen, students prefer to complete their higher education first. 2 School of Life Sciences, University of Hyderabad Central University (P.O) Hyderabad-500 046 Tel.: +91-40-23010500 Website: http://www.uohyd.ernet.in The School of Life Sciences at University of Hyderabad has been established with an objective to teach and conduct research with a multidisciplinary approach. The teaching programs are designed in a such a manner to provide the basic chemical and physical aspects of life as well as to impart information about the new frontier areas of Life Sciences. The School consists of three departments namely, Department of Biochemistry, Department of Plant Sciences and Department of Animal Sciences. Each of these departments offers MSc. and PhD programs of study. In addition, the school also offers a course in MSc. Biotechnology with the combined effort of all the three Departments. The Universities Grants Commission recognized the School of Life Sciences for Special Assistance in the year 1990. The special assistance program has been upgraded at the level of DSA in 1997 for a duration of five years with the following thrust areas for teaching and research: Molecular Biology and Neurochemistry, Plant Physiology and Molecular Biology, and Animal Physiology and Reproductive Biology. The School has also been granted COSIST program of UGC since 1999 in above areas, for duration of five years. It also offers Post Graduate Diploma in Bioinformatics. 3 Institute of Chemical Technology, Food Engineering & Technology Department, Mumbai University of Mumbai, Nathalal Parikh Marg, Matunga, Mumbai â€“ 400019 Tel.: +91-22-24145616 Website: http://www.udct.org/ The Department of Food and Fermentation Technology at Institute of Chemical Technology (ICT) (autonomous), earlier known as Department of Foods & Drugs has been offering M Tech (Bioprocess Technology) an interdisciplinary course. It was started in 1993 through the funding of government of India (Department of Biotechnology). The total number of intake for this course is 30 with DBT fellowship seats as well as industry sponsored seats. There are 17 faculty members and several distinguished persons from industry and other institutes are invited as visiting fellows for giving quality input to the education and training imparted to the students. The major research interests include carbohydrate chemistry and technology with focus on Indian traditional foods; fermentation technology with focus on enzymes, plant cell culture, neutraceuticals and GM foods and food microbiology related to quality, safety and application of new technology. The department has been supported and recognized by various funding agencies like MHRD, AICTE, DST, UGC, and DBT to name a few. 4 IIT, Department Of Biochemical Engineering & Biotechnology, Delhi Indian Institute Of Technology Delhi, Block I-224, Hauz Khas, New Delhi - 110 016 Tel.: +91-11-26591001/26596109 Website: http://www.iitd.ac.in/deptt/beb/ The Biochemical Engineering & Biotechnology course at IIT Delhi is a unique model for an integrated approach towards education as well as research and development of various bioprocesses. The objectives of the Department of Biochemical Engineering & Biotechnology (BEB) are: training students and developing expertise in biochemical engineering, biotechnology at the postgraduate and PhD levels; research and development of various microbial and enzyme system and developing understanding of biological/biochemical phenomena underlying such systems; engineering analysis and optimal design of various biological systems and processes; transfer of knowledge through seminars, symposia and short-term refresher courses at national and international levels; and undertaking industrial consultancy jobs to solve the specific problems of bioprocess industries. As the BEB course has been running since many years, over the years it has built up some expertise as well as an elaborate infrastructure and equipment base for carrying out teaching, research and development activities in the area of biochemical engineering and biotechnology.The Department also offers a summer training program in May/June every year to provide intensive practical training to post graduate students. 5 The Center For Biotechnology, Anna University Anna University, Chennai - 600 025 Tel.: +91-44 -22350772/22350299 Website: http://www.annauniv.edu/biotech The Center for Biotechnology (CBT) was established in 1987 in Anna University with a financial support from Department of Biotechnology, University Grants Commission, and Anna University with an objective to provide educational and training facilities in different areas of biotechnology to carry out fundamental research and to promote research and consultancy activities. The CBT offers teaching programs in B Tech in industrial biotechnology, food technology, pharmaceutical technology and MTech in biotechnology and also offers PhD and research programs. The CBT has research laboratories in different areas such as tissue culture and drug discovery, molecular immunotechnology, immunotechnology, bio-organic and computational biology, protein biotechnology, molecular biology, genetic engineering and molecular biology, bioprocess engineering and bioprocess technology and automation. It has entered into tie up with a leading pharmaceutical company like Nicholas Piramal India Ltd. The Techno Business Incubator Park (TBI) is an initiative of the Center for Biotechnology with a financial support from Department of Biotechnology, Delhi. 6 Department of Management Sciences (MBA- Biotech), University of Pune University of Pune,Ganeshkhind, Pune (M.S.) - 411007 Tel.: +91-20-25693380/0477 Website: http://pumba.unipune.ernet.in The Department of Management Sciences, University of Pune, has been offering MBA in Biotechnology, one of the newest disciplines in management, encompassing management and biotechnology. University of Pune (PUMBA) has started this pioneering program from the academic year 2002-2003 (intake capacity 60). This is the first such program in any Indian University/Institute and probably in the world. PUMBA is amongst the leading departments of the University of Pune, which provides its students with every possible input required to afford them a clear understanding of the fundamentals of management. Armed with this self-assuredness that comes only with the mastery of one's subject, the students at PUMBA are in the best position to transform their dreams into reality. "PUMBA, the in-house MBA department of the University of Pune, in a tradition true to our University, has successfully managed to interweave the corporate prerequisites with the academic curriculum. This has been made possible, thanks to PUMBA's sincere and diligent endeavors to take cognizance of the collective voice of the corporate. Located in the environs of the industry, PUMBA has its finger firmly placed on the pulse of the industry," said Dr Ashok Kolaskar, Vice Chancellor, University of Pune. 7 Madurai Kamaraj University, School of Biotechnology, Madurai Madurai Kamaraj University, Madurai - 625 021,Tamil Nadu, India. Tel.: +91-452-2459115 Website: http://www.biotechmku.org/ The School of Biotechnology at Madurai Kamaraj University, which was earlier the Department of Biotechnology under the School of Biological Sciences, was elevated to the level of School of Biotechnology in 1994. The School, with its strength of 11 fulltime faculty members, is teaching two national level courses, which are very competitive and are rated at a very high level. The school has national level facilities that include Center for Genetic Engineering and Strain Manipulation, Bioinformatics Center, Center for Plant Molecular Biology, High Resolution Graphics and DNA Sequencing Facility. The School of Biotechnology has three departments. The team at Department of Genetic Engineering is involved in research and teaching in the areas of genetic engineering, biophysics, bioinformatics, immunology and immunotechnology. Research teams of the Department of Molecular Microbiology are involved in applying advanced recombinant DNA and genetic engineering techniques to develop microbes/microbial products. 8 Amity Institute of Biotechnology, MBA Biotechnology, Noida Sector - 125, Amity Campus, Express highway, Noida, Uttar Pradesh - 201 303 Tel.: +91-120-2432400 Website: www.amity.edu/aib The Amity Institute of Biotechnology (AIB), located in NOIDA was established in August 2001. The institute provides a range of courses in the biotech arena like BTech biotechnology, BTech Bioinformatics, Integrated MTech Biotechnology, Integrated MSc Biotechnology, PG Diploma in Bioinformatics, MBA Biotechnology, MSc Biotechnology and MSc Bioinformatics courses. Its MBA biotechnology course program was started in 2003. The course offers a generic management program to provide students with a broad-based introduction to biotechnology and to introduce the theory and practice of management and management skills. Its first batch of MBA biotechnology students successfully passed in 2005 and all of them (barring a few who are pursuing higher studies abroad) have found jobs in the industry. The Corporate Resource Center (CRC) of the institute consists of a dedicated team, which works together with the student placement committee to ensure that the best companies come to campus. AIB possesses good infrastructure in terms of laboratories for plant and animal tissue culture, microbiology, central instrumentation facility, computational biology, biochemical techniques and molecular biology. 9 Entomology Research Institute, Loyola College, Chennai Loyola College Chennai - 600 034. Tel.: +91-44-28178348 Website: http://loyolacollege.edu/entomologyresearch.html The Entomology Research Institute (ERI), located within the campus of Loyola College, Chennai is a unique center of academic excellence in the country. It was founded by a pioneering and eminent entomologist Dr T N Ananthakrishnan, a retired professor of Zoology in Loyola College and the former Director of the Zoological Survey of India, The present Director Fr Ignacimuthu, SJ and four other scientists, comprise the institute's Research Faculty. More than 20 students are carrying out doctoral and postdoctoral research sponsored by different national and international funding agencies. The ERI is devoted to the investigation on diverse aspects of insect-plant interactions. Value-based areas of applied significance are being pursued. These are biological control, insect behavior, biodiversity, biopesticides, molecular biology, microbiology, genetic engineering, tissue culture, phytochemistry and medicinal chemistry. It also organizes extension programs for farmers and school children.The ERI has publications of about three dozen books on a variety of topics and research papers exceeding 600. 10 GGS Indraprastha University, University School of Biotechnology, Delhi University School of Biotechnology, Kashmere Gate, Delhi â€“ 110 006 Tel.: +91-11-23867038 Website: www.ipu.ac.in The School of biotechnology at Guru Govind Singh Indraprastha University was established in 1999 at the Kashmere Gate Campus in Delhi. The program places due emphasis in the curriculum on interdisciplinary convergence in modern biology, engineering and technology, applied orientation, quantitative approach, practical training, awareness of the broader social, economic, environmental, ethical, legal and managerial issues in biotechnology, etc. The school offers a 5½ year (11 semester) integrated B. Tech./M. Tech. program in biotechnology through an All India entrance examination. The school has a strong research program and PhD is offered in various disciplines of biotechnology like agricultural, environmental, industrial, biomedical and pharmaceutical biotechnology. The School offers both teaching/learning oriented and research-oriented programs.The aim of the department is to attract quality faculty and build in-house competencies in all aspects of biotechnology; Focus the teaching and research investments strategically around national economic goals; Empower the students with the latest tools, techniques and awareness in biotechnology. Facilitate comprehensive learning combining the scientific, technological and social aspects; Seek new models of collaboration with other institutes, universities and industries.   ]]> <![CDATA[Parameter Scores of the Top 20 Biotech Institutes]]> https://biospectrumindia.com/news/95/1559/parameter-scores-of-the-top-20-biotech-institutes.html https://biospectrumindia.com/news/95/1559/parameter-scores-of-the-top-20-biotech-institutes.html Wed, 11 Jan 2006 16:54:00 +0530 Table 2 Table 2: Parameter Scores of the Top 20 Biotech Institutes                                                                                                            Score(Max:100)        Name of the Organization Public-1/ Private-2 Faculty   Infrastructure   Industry Interaction Placement   Final (weighted) Ranking Jawaharlal Nehru University,               Centre for Biotechnology, Delhi 1 47.29 72.07 71.81 0 49.69 1 School of Life Sciences,               University of Hyderabad 1 66.52 52.72 33.33 3.32 44.15 2 Institute of Chemical Technology,               Food Engineering & technology Deprt, Mumbai 1 42.24 15.12 57.16 55.98 38.69 3 IIT, Department Of Biochemical Engineering & Biotechnology, Delhi 1 43.97 17.01 20.87 28.19 28.49 4 Anna University, Centre For Biotechnology. 1 27.83 8.26 30.31 44.06 25.21 5 University of Pune, Department of Management Sciences 1 18.98 8.42 0 72.72 23.31 6 Madurai Kamaraj University, School of Biotechnology, Madurai 1 25.27 38.66 14.79 0 22.82 7 Amity Institute of Biotechnology, MBA Biotechnology, Noida 2 25.28 32.12 0 19.24 22.21 8 Entomology Research Institute, Chennai 1 28.68 35.26 8.19 0 21.77 9 GGS Indraprastha University, University school of Biotechnology Delhi 1 20.09 35.09 6.26 10 20.66 10 Jaypee Institute of Information Technology, Biotechnology, Noida 2 31.89 17.72 0.06 5.64 17.01 11 The Oxford College of Science, Department Of Biotechnology,  Bangalore 2 24.12 15.08 0 21.31 16.81 12 Banasthali Vidyapith, Department Of Bioscience & Biotechnology, Rajasthan 1 37.48 13.1 1.6 0 16.44 13 Tamil Nadu Agricultural University,               Deprt of Plant Molecular Biology & Biotechnology 1 36.54 14.39 0.22 0 16.33 14 National Institute of Pharmaceutical Education & Research, Department Of Biotechnology & Dept Of Pharmaceutical technology,  Punjab 1 18.3 8.1 0 34.55 15.36 15 M.S University of Baroda, Dept of Microbiology & Biotechnology Centre, Vadodara 1 22.71 4.3 16.88 18.42 15.03 16 Bangalore University, Dept Of Microbiology Karnataka 1 29.27 10.39 8.47 3.29 14.7 17 Calcutta University, Dr. B C Guha Centre For Genetic Engineering & Biotechnology 1 15.53 12.13 5.5 21.8 14.09 18 Shree Manibhai & Navalben Virani 2 26.71 15.81 0.4 0 13.67 19 Science College, Dept Of Biotechnology,  Rajkot T.John College , Department O f Biotechnology 2 22.26 2.69 0 27.34 13.45 20 ]]> <![CDATA[India's Top Biotech Schools]]> https://biospectrumindia.com/news/95/1253/indias-top-biotech-schools.html https://biospectrumindia.com/news/95/1253/indias-top-biotech-schools.html Wed, 11 Jan 2006 15:23:00 +0530 India India's Top Biotech Schools Ranking of institutes imparting biotech education in India. Biotech is the latest sunrise sector. Analysts feel that biotech industry may surpass IT and ITeS in overall growth and employment generation, forex earnings, patent registration, etc. India is considered as one of the hottest biotech destinations. And several people across the world believe that India will be able to produce companies of the level of Amgen in the future. India's skill and capabilities in biotech is well recognized. But the rapid growth of the industry will ultimately depend on availability of quality manpower and good educational institutions in country. In last one decade, a large number biotech institutes were set up. However, not much has been done for benchmarking of these institutes for their own relative assessment, for industry and for aspiring students. In order to fill the void, BioSpectrum conducted a study to rank the biotech institutes last year and has continued with the effort this year as well. BioSpectrum's Top Biotech Schools 2005 study included information pertaining to BTech, Masters and PhD courses but not of BSc. courses. This study was conducted in association with CyberMedia Research. To maintain objectivity and avoid biases in ranking the institutes, CyberMedia Research decided to base its methodology on measurable and quantifiable data. As a result, the research team did not seek perceptions and opinions of stakeholders such as students or industry to rank the institutes. Both CyberMedia Research team and BioSpectrum team worked together on this study. While CyberMedia Research team worked on conceptualizing the study, designing the questionnaire and analyzing the data for ranking of the institutes, BioSpectrum team decided on the institutes to be invited for participation in the study, co-ordination with the biotech institutes for collection, sufficiency, adequacy and consistency of the data shared by them. Jawaharlal Lal Nehru University, the top institute Amongst all institutes and colleges, which are imparting education at the undergraduate and/ or postgraduate level in the area of Biotech, Jawaharlal Lal Nehru University emerges as the best top ranked institution in the country. It is followed by University of Hyderabad, Hyderabad at the second position, Institute of Chemical Technology, Mumbai at the third position, IIT, New Delhi at the fourth and Anna University, Chennai at the fifth position. Rank 1... Jawaharlal Lal Nehru University, Delhi Rank 2... University of Hyderabad, Hyderabad Rank 3... Institute of Chemical Technology, Mumbai Rank 4... IIT, New Delhi Rank 5... Anna University, Chennai As one would expect, amongst the Top 20 Biotech institutions in India, 15 are public and only five are in the private sector (Table 1). Barring last few years in which private sector has invested money in higher education; education has largely been in the public domain. Amity Institute of Biotechnology (MBA Biotechnology), Noida, Jaypee Institute of Information Technology, Biotechnology, Noida, The Oxford College of Science, Bangalore, Shree Manibhai & Navalben Virani Science College, Rajkot, T John College, Bangalore are the five institutions in private sector which occupy slots amongst India's Top 20 institutions in Biotech area. It may further be observed that only Amity Institute of Biotechnology, MBA Biotechnology, Noida figures amongst top 10 institutes. Table 1: Top 20 Ranking of Institutes  Offering Biotech Courses Name of the Organization Public-1 Private-2 Final Score (weighted) Ranking Jawaharlal Nehru University, Centre for Biotechnology, Delhi 1 49.69 1 School of Life Sciences, University of Hyderabad, Hyderabad 1 44.15 2 Institute of Chemical Technology, Food Engineering & Technology Department , Mumbai 1 38.69 3 IIT, (Department Of Biochemical Engineering & Biotechnology), Delhi 1 28.49 4 Anna University, Centre For Biotechnology, Chennai. 1 25.21 5 University of Pune, Department of Management Sciences, Pune 1 23.31 6 Madurai Kamaraj University, School of Biotechnology, Madurai 1 22.82 7 Amity Institute of Biotechnology, MBA Biotechnology, Noida 2 22.21 8 Entomology Research Institute, Loyola College, Chennai 1 21.77 9 GGS Indraprastha University, University School of Biotechnology, Delhi 1 20.66 10 Jaypee Institute of Information Technology, Biotechnology, Noida 2 17.01 11 The Oxford College of Science, Department Of Biotechnology ,  Bangalore 2 16.81 12 Banasthali Vidyapith, Department Of Bioscience & Biotechnology, Banasthali 1 16.44 13 Tamil Nadu Agricultural University, Department of Plant Molecular Biology & Biotechnology, Coimbatore 1 16.33 14 National Institute of Pharmaceutical Education & Research, Department Of Biotechnology & Department Of Pharmaceutical technology, Mohali 1 15.36 15 M.S University of Baroda, Department of Microbiology & Biotechnology Centre, Vadodara 1 15.03 16 Bangalore University, Department Of Microbiology, Bangalore 1 14.7 17 Calcutta University, Dr. B C Guha Centre For Genetic Engineering & Biotechnology, Kolkata 1 14.09 18 Shree Manibhai & Navalben Virani Science College, Department Of Biotechnology ,  Rajkot 2 13.67 19 T. John College, Department Of Biotechnology, Bangalore 2 13.45 20   One big difference between the private and the public institutes is that the private players focused more of procuring the placements. And the students from the public institutions mostly preferred to go for higher education. Probably, this is why institutes offering MBA Biotech-Amity and Pune-have made it to the top 10. In fact Pune University ranks very high (#6) in the overall scheme of things. As has been mentioned earlier, four parameters have been used to arrive at the overall score or ranking-Faculty, Infrastructure, Industry interaction and Placements. As one would observe, a lot of new institutes have been in this list. The reason for this is the biotech education in the private sector is fairly new and a lot of them stressed on building their infrastructure. The priorities of the students joining the private institutes compared to the established institutes are different. They want to go to the institute with the faculty and repute and pursue higher studies.   ]]> <![CDATA[Advice from biotech experts]]> https://biospectrumindia.com/news/95/1891/advice-from-biotech-experts.html https://biospectrumindia.com/news/95/1891/advice-from-biotech-experts.html Wed, 11 Jan 2006 15:19:00 +0530 Advice from biotech experts Advice from biotech experts On the Success Path From its inaugural issue, BioSpectrum has been flooded with queries from thousands of students, mainly about career opportunities, course curriculum and future guidance in biotechnology. We have made an effort to put together some frequently asked questions (FAQs) by students and their replies as given by experts during our interaction with them. Curriculum Is the current curriculum adequate and if not what changes should be made? What should be the role of industry in driving curriculum modification? Typically in any biotech course, about 1/3 of the education is completed in the college laboratory and the rest 2/3 is learnt hands-on, in the industry. The rate of obsolesce of biotechnology is very fast and the half-life of biotech knowledge is less than 3 years. So upgradation is necessary. No curriculum is adequate and it has to be constantly updated. The course requires frequent changes and the industry should be involved in designing the courses due to the technology factor. Today there are many technopreneurs who can give valuable inputs for the course content. They should be part of the advisory body of the universities/educational institutes and there should be professional chairs in the modern biotech institutes. Students should come up as a body and demand changes. They should not entirely depend on the policy and course makers. Academics will always keep evolving. On an average technically Indians are phenomenal, but both the aptitude and attitude is important. Students should be assertive and ready to take risks. They should focus on individual development and cultivate managerial skills. Should the focus be on Specialization or Generalization in the subject? Both a broad generic base and focused knowledge are equally important in the biotech discipline. Biotechnology is not physics and chemistry, which is limited by boundaries. The education should be two-tiered. First a broad based providing the basic information about biosciences/modern biology should be built while the next tier should be very focused and job oriented. The bottomline is to breed excellence and not mediocrity. Qualification Should a student opt for a Bioengineering (BTech, MTech) or a Biosciences (BSc, MSc) degree in biotechnology? Essentially, if one has an aptitude for innovation, an urge to develop something for mankind, only then should one get into the biotechnology stream. Bioscience courses are specialized programs with a focus on research and development. It equips a student to pursue further R&D in the area of vaccines, diagnostics, agriculture, etc whereas biosciences in synergy with mathematics and biology is bioengineering. It would constitute of, for example, a new process leading to a new technology, which ultimately leads to a new product. It is also the use of engineering principles to develop a niche area like the concept of plant bioreactors where biomass is used as a feedstock to develop products. BTech and MTech students are more suited for roles in the quality assessment/quality control, fermentation and production arena. Is it necessary to have a doctorate degree or can one get good jobs after a Master's degree? What is the scope for an MBA biotechnology student? The baseline is that there is no necessity of a PhD degree. With an MSc, MTech, BTech degree, one is equipped to do the routine activities like quality control, quality assurance, processing, production, downstream processing and fermentation whereas if one is looking at developing IPR for a company or go into innovative research, then it is preferable to have a PhD degree. Finally, it is your mindset, which is important and not the degree. Similarly with an MBA biotech degree you are more equipped towards marketing, marketing analysis and business development activities. Career Opportunities How can a student plan his career after a degree in biotechnology? There are basically three types of students: First those who look for higher education; Second, who opt for a job immediately after coming out from the college; and the third who look at becoming entrepreneurs. Students should have clarity in mind and focus on what they want. For pursuing future research, there are large opportunities both in the academia and the industry. The various universities, national research labs, ICMR institutes and Centers of Excellence provide a wide variety of options for students looking at higher education. The core recombinant technology areas for research are agriculture, medical research and healthcare (including services), industrial biotechnology, environmental biotechnology, bioenergy and biofuels. Students wanting to work in the industry can look at the areas of R&D, manufacturing, quality assessment/control, sales and marketing and marketing analysis. There are also a number of opportunities for working in the area of environment like the biological diversity arena. Since India is a signatory to the Convention on Biological Diversity, which is dedicated to promoting sustainable development, we will need trained people in this area for the different regional offices to measure biodiversity, document its loss and extinction. The implementation of the biosafety measures will also require thousands of students. Some of the other areas are working on new agrotech practices, novel pesticides and biofertilizers. A large number of knowledge centers are needed in the rural areas which will employ educated youth for transforming the farming practices and promoting the concept of biovillage. This is similar to the rural development program in China. So students can do wonderful work in the rural technology centers in smaller cities and towns. In this way, the BSc/MSc biotechnology students can play a useful role in the Rural Bioresource Council. What are the opportunities available for biotech personnel in the private sector? Today, there is a specific requirement of quality manpower for the third generation of biotechnology. Till now, many a times, it has been seen that good scientists hesitate to come to the industry. Budding biotechnologists should remember that the biotech industry is now involved in innovative research and development. Earlier companies were spending about 5-10 percent of the total turnover into innovative R&D but of late they are investing 15-20 percent of the total turnover into it. Though the Indian industry is still at a nascent stage of indigenous research and process development, its scientific environment (facilities) have been built consciously, which is very good. Students having an innovative bent of mind can enter this arena. Besides research there are openings at various levels like in quality control, marketing and sales, regulatory sector, technology transfer, clinical trials and in the bioservices segment (CROs). Since the industry has become more competitive, it has specific human resource requirements, which it finds hard to fulfil. Presently, most of the students are like technicians and there is a great dearth of talent. It is important to remember that the industry is for profit and will identify the person based on his skills and attitude. What is the advice for an aspiring entrepreneur? There is great scope of technical entrepreneurship, in the biotech area. According to Jeffery Sachs, "Technology creates wealth". Today opportunity plus environment is equal to success. In today's times there is a focus on globalization and biology. If students have an entrepreneurial streak, they must start dreaming about their proposed venture early. And remember that every activity may require some route of development. They should identify the business opportunity, do the market assessment, consult people and gather a lot of information. For this, one should plan in advance. While pursuing their degree courses, students should identify 3-4 potential areas and zero down on one choice. Then identify a product in that area and develop, for instance, a process plant design. During the final year of study, work on a mini package and give the project a year's time to incubate. This entrepreneurship model is feasible and students should embrace it in large numbers. For a start up bioservices is also an attractive option providing immense opportunities in areas like gene optimization, manufacturing process optimization, cell line characterizing among others. Presently, students pursuing their biotech masters degree program do not understand anything about business-how to design a business plan, how to tackle regulatory issues, etc. There should be some capsulated program which given them an orientation in this area. Future Direction Which are the promising biotech sectors likely to see high growth in the coming 5-7 years? If there is any area of science that will flourish after information technology, then it is biotechnology. There is proliferation of modern biology/biotechnology in all areas of life. The fields of diagnostics, vaccines, clinical trials, therapeutics are some of the upcoming areas. The development of kits, equipments in the services sector is equally important. In the next 2-3 years, the field of phyto/bioremediation technology may surpass the pharma field in the US and it will be a money-spinner. The area of bioprospecting has emerged and India has a genetic gold rush of bio resources, which require high throughput screening. Now things are being looked at a molecular level. It is required to have interdisciplinary knowledge and experience to venture in the areas of molecular medicine. The era of genomics has started, with the sequencing of the human genome and specialized trained manpower in molecular virology, genetics, molecular immunology, stem cells, molecular immunology and molecular monoclonal antibodies are required. In the next 5 years, according to American estimates there would be requirement of bioinformaticians. People with both bioinformatics and other biotech related skills are required and both have to work complementary to each other. Today we have very limited human resource in the area of modern biology in India. Along with these there is also a requirement of professionals with a masters qualification along with law or MBA. ]]> <![CDATA[Institute of Himalayan Bioresource Technology (IHBT), Palampur]]> https://biospectrumindia.com/news/95/2159/institute-of-himalayan-bioresource-technology-ihbt-palampur.html https://biospectrumindia.com/news/95/2159/institute-of-himalayan-bioresource-technology-ihbt-palampur.html Wed, 11 Jan 2006 15:09:00 +0530 A Network of Sophisticated Labs Institute of Himalayan Bioresource Technology (IHBT), Palampur The IHBT is involved in the establishment, upgradation, and sustainable management of bioresources in the Himalayan region through agrotechnology, processing technology and biotechnology. The institute provides R&D services on economic bioresources in western Himalayan region leading to value added plants, products process for industrial, societal and environmental benefit. It is engaged in research in three major areas: plant tissue culture; plant molecular biology; and plant physiology and biochemistry. Plant tissue culture aims at micro propagation of economically important plants like tea, bamboo, rose, ornamentals, and medicinal plants. Plant molecular biology focuses on DNA- fingerprinting, identifying cloning of genes, developing transgenics, etc. Plant Physiology emphasizes basic aspects of plant adaptations at high altitude, basis of dormancy, seed biology, and senescence in tea and ornamentals. The plant tissue culture lab of the unit has a modern culture room with automated shakers, microscopes with CCD, an exclusive area for washing and media preparation, a series of greenhouses / polyhouses for hardening of tissue culture raised plants, a biolistic gun and containment facility for undertaking studies on transgenics and a bioreactor for carrying out studies on secondary metabolites. The Plant physiology and seed biology lab has a cryogenic facility. The Plant molecular biology lab is well equipped to work on genomics and proteomics. The unit has PCRs, gel document systems, 2-D electrophoresis system, manual and automatic sequencer, phosphoimager, high-end equipments like QToF, Spot cutter and Spot digester. Indian Institute of Chemical Biology (IICB), Kolkata The Institute was established in 1935 as the first non-official centre in India for biomedical research and was included within the aegis of CSIR in 1956. IICB today is engaged in research on diseases of national importance and biological problems of global interest, employing sophisticated state-of-the-art technology in keeping with the rapid and unprecedented momentum that life science research has gained globally over the last 50 years. The scientific staff has expertise in a variety of areas including chemistry, biochemistry, cell biology, molecular biology, neurobiology and immunology, which promotes productive interdisciplinary interaction. IICB is one of the major laboratories in India, which initiated, right from its inception, multidisciplinary concerted efforts for conducting basic research on infectious diseases, specifically leishmaniasis and cholera, along with the development of technologies for the diagnosis, immunoprophylaxis, and chemotherapy of the diseases. The institute has developed an oral vaccine for cholera, herbal products for controlling gastric ulcer, empirical treatment for vitiligo, diagnostic kits for malignancy and hormonal disorders, fungal enzymes of industrial importance, radio pharmaceuticals for evaluation of the functional status of renal and hepatobiliary systems and a device for early detection of Parkinson's disease. Although the strength of IICB has always been basic biomedical research, during the last decade emphasis has been on goal-oriented research directed towards commercial exploitability. Efforts are now on to convert the knowledge gained over the years through high quality basic research into wealth. Central Salt & Marine Chemicals Research Institute (CSMCRI), Bhavnagar The Central Salt & Marine Chemicals Research Institute was established in 1954. Currently the research and development activities of the institute dwell around three areas: Inorganic chemicals, catalysis and new materials; Membrane science and separation technology; and biosalinity. The aquaculture of economically important seaweeds and recovery of phycocolloids and other important products from seaweeds; wasteland development through cultivation of desert economic and halophytic plants in arid, semi-arid and saline lands and recovery of important products from them are some its important focus areas in field of life sciences. The mission of the Institute and its people is to work in partnership with sponsors and collaborators to generate the knowledge and innovations required for efficient utilization of our coastal wasteland, seawater, marine algae, solar power and silicates. The Institute plans to harness its capabilities in biosciences, chemical transformation, process engineering, environmental monitoring, separation science and analysis to address focused needs of industries and organizations in the region and beyond. Regional Research Laboratory (RRL), Jorhat The Regional Research Laboratory (RRL), Jorhat was established in 1961 and its major thrust of R&D activities has been to develop indigenous technologies by utilizing the immense natural wealth of India. The North Eastern Region of the country being bestowed with an abundance of material resources like petroleum, natural gas, minerals, tea as well as aromatic and medicinal plants, the laboratories undertake research for development of know-how for a wide a range of industries and extension works. In the life sciences arena, the focus is on research on aromatic and medicinal plants, exploration of microbes and screening them for novel metabolites for biotechnology-based processes. Over the years, the laboratory has generated more than 100 technologies in the areas of agro technology, biological and oil field chemicals of which about 40 percent were of commercial success culminating in setting up of various industries through out the country. The laboratory also developed expertise in the areas like natural products chemistry, drug and drug intermediates, VSK cement, plant technology, agro-technologies, petroleum microbiology and petrochemicals, crude oil transportation, paper and paper products, beneficiation chemicals, ecology and environmental studies, geotechnical investigations, foundation design engineering, soil and building materials etc. Regional Research laboratory (RRL), Thiruvananthapuram RRL, Thiruvananthapuram is engaged in R&D programs in the area of agroprocessing, chemical sciences, materials and minerals, biotechnology and process engineering and environmental science and technology. The programs have a blend of basic research and technology development and commercialization; have specific thrusts on frontier areas of research, National Mission Projects, regional resource-based activities and R&D-Industry-Academia linkages. The laboratory has excellent collaborative programs with major national and international agencies too. In the biotech arena the institute focuses on development of biocatalysts, bioactive compounds, secondary metabolites and other value added products from plants and microorganisms utilizing the regional resources for various industrial applications with special reference to healthcare and green technologies. The Specific areas of R&D are: Microbial/Enzyme/Bioprocess Technology; Microbial Genomics; Persistent organic pollutants research; Development of bioprocess for the production of alcohol from cassava; Development of laboratory bioprocesses for the production of industrial and therapeutic enzymes, which include glucoamylase, alpha amylase, protease, lipase, L-glutaminase, xylanase, phytase, and inulinase; Development of laboratory bioprocess for the production of L-glutamic acid, citric acid, aroma compounds and mushrooms; Solid-State Fermentation (SSF) processes and systems; Process development for bioconversion of agro-industrial residues, in particular those available in the region; Quality improvement of alcohol produced by a distillery with increased productivities; Laboratory process on the development of two-stage anaerobic up-flow bioreactor for the treatment of digestion of natural rubber effluent. Indian Institute of Chemical Technology (IICT), Hyderabad IICT offers globally competitive and environmentally viable technologies for drugs and drug intermediates, organic and inorganic chemicals, agrochemicals, catalysts, polymer coatings, adhesives, oils and many other technologies. IICT also offers wide-ranging knowledge based services in analytical testing and characterization, new molecule and product development, process upgradation and restandardization, process safety studies, design-engineering and project viability studies. In the biotech arena, it focuses on high quality basic and applied research in bioinformatics, entomology and toxicology besides developing specialty chemicals, biodiesel and nutraceuticals. IICT 's basic objectives have always been to carry out research in the chemical sciences leading to innovative processes for a variety of products necessary for human welfare such as food, health and energy and the conduct of R&D work is fully geared to meet the requirements of technology development, transfer and commercialization. Process development work, particularly for bulk chemicals is carried out at appropriate pilot plant scale to collect techno economic and design data. With the help of excellent design and engineering expertise available, the institute has been providing engineering designs for commercial plants with standard commercial guarantees. More than 150 technologies developed by IICT are now in commercial production. With over 450 highly professional and dedicated scientists and technical officers/technicians, excellent laboratory and instrument facilities for research in chemical sciences and technology and allied sciences, IICT is known nationally as well as internationally for its contributions both in basic and applied research. Regional Research Laboratory, Jammu RRL, Jammu is a multidisciplinary research institute engaged in R&D on Bioprospecting of natural molecules; Biotechnology- fermentation and enzyme technology, microbial bodiversity, molecular biology and gene cloning; Natural products chemistry; Cultivation and Utilization of drugs and essential oil bearing plants and Chemical Engineering and Design backup for packaging of technologies. It is engaged in two major areas of research namely-drug design and development and microbial biotechnology. The division of biotechnology at Regional Research Laboratory, Jammu is an established centre for fermentation, molecular biology and genetic engineering in microbes and plants. The core facility of this research laboratory is its pilot plant, with microprocessor controlled fermentors and sophisticated equipments required for microbiology, biochemistry, enzymology, genetic engineering and bio-chemical engineering. The biotech division has four subunits: Microbiology; Fermentation technology; Genetic engineering; and Enzyme technology. In the Microbiology unit of the division, isolation of microbes, their identification, characterization, preservation and screening for specific microbial enzymes and secondary metabolites are carried out. Among the enzymes the emphasis is on the presence of industrially important enantio/ regio-specificity. The microbial strains encoding such enzymes are identified up to species level by 16S rRNA gene typing. Selected wild type and recombinant strains are grown at lab to pilot scale fermentors. The strategies of scale-up or scale-down are selected depending upon the nature of the process under study. National Institute of Oceanography (NIO), Goa Marine biotechnology is an important area of research at the National Institute of Oceanography. The institute has expertise in the areas of marine biology, biodiversity, bioorganic chemistry and microbiology. It is actively engaged in the discovery of novel drugs, nutraceuticals, industrial enzymes and other useful products. It was established on January 1, 1966 following the International Indian Ocean Expedition (IIOE) in the 1960s. While the headquarters of the institute is at Dona Paula, Goa, NIO has regional centres located at Kochi, Mumbai and Visakhapatnam. NIO's real strength lies in trained manpower developed the during last four decades for basic ocean research. Over 150 individuals and groups from the institute have studied the special features that the North Indian Basin offers and have made handsome contributions to knowledge regarding the ocean. Over 400 technical and supporting staff backs up the research workers. Besides, the institute gives an opportunity for the fresh graduates to work as project trainees on various projects. The institute has recently signed a MoU with Pancham Aquaculture Farms, Mumbai for development of technologies and products for sustainable coastal aquaculture and their health management. NIO with its vast experience in aquatic resource assessment and environmental management will provide the company with scientific, technical and aquatic health solutions to the sustainable coastal aquaculture and disease management. Central Leather Research Institute (CLRI), Chennai CLRI is one of the premier R&D organizations in the country with a strong foundation in both basic and applied research in leather and allied sciences. In 1996, the Apex Court declared the closure of 400 tanneries in Tamil Nadu citing serious environmental problems of tannery effluents. Nearly 148 scientists from CLRI demonstrated cleaner leather process technologies in tanneries and undertook the responsibility of providing the know-how on plant pollution control measures. The result: today almost all the tanneries in Tamil Nadu have either established Effluent Treatment Plants (ETPs) or connected to the CETPs. "Probably, this is one example of its kind in India where science really solved a national problem," remarked Dr T Ramasami, director, CLRI. CLRI is one of the few laboratories in the world to recognize the value of biotechnology in leather research. Activities in the area of biotechnology in CLRI took a definite shape in 1990. Since then the focus is in the areas of enzyme technology, in vivo and in vitro studies on connective tissue metabolism and in the development of plant and synthetic drugs for use in the animal models for myocardial infarction and arthritis. In addition, the department provides training in the above areas for carrying out PhD, M Tech and MS Programs of the University of Madras, Anna University, BITS and other universities. ]]> <![CDATA[A Network of Sophisticated Labs]]> https://biospectrumindia.com/news/95/2851/a-network-of-sophisticated-labs.html https://biospectrumindia.com/news/95/2851/a-network-of-sophisticated-labs.html Wed, 11 Jan 2006 15:01:00 +0530 A Network of Sophisticated Labs A Network of Sophisticated Labs A Cut Above The Council of Scientific and Industrial Research (CSIR) with its 38 laboratories and 39 field stations spread across the country is among the world's largest publicly funded R&D organizations. Manned by around 8000 scientists and engineers, the various CSIR research labs provide globally competitive R&D inputs and high quality science based services. Nineteen CSIR labs have a special focus on biotechnology and provide excellent research opportunities for students post their education. These institutes are: â€¢ Institute of Genomics and Integrative Biology (IGIB), Delhi â€¢ Centre for Cellular and Molecular Biology (CCMB), Hyderabad â€¢ Central Drug Research Institute (CDRI), Lucknow â€¢ Central Food Technological Research Institute (CFTRI), Mysore â€¢ Central Institute of Me dicinal and Aromatic Plants (CIMAP), Lucknow â€¢ Institute of Himalayan Bioresource Technology (IHBT), Palampur â€¢ Indian Institute of Chemical Biology (IICB), Kolkata â€¢ Institute of Microbial Technology (IMT), Chandigarh â€¢ Industrial Toxicology Research Centre (ITRC), Lucknow â€¢ National Botanical Research Institute (NBRI), Lucknow â€¢ Regional Research Laboratory (RRL), Jammu â€¢ Central Leather Research Institute (CLRI), Chennai â€¢ Central Salt & Marine Chemicals Research Institute (CSMCRI), Bhavnagar â€¢ National Chemical Laboratory (NCL), Pune â€¢ National Environmental Engineering Research Institute (NEERI), Nagpur â€¢ National Institute of Oceanography (NIO), Goa â€¢ Regional Research Laboratory (RRL), Jorhat â€¢ Regional Research laboratory (RRL), Thiruvananthapuram â€¢ Indian Institute of Chemical Technology (IICT), Hyderabad A brief snapshot of these institutes is presented here. Central Food Technological Research Institute (CFTRI), Mysore CFTRI Mysore is an ISO 9001 and NABL accredited CSIR laboratory. The institute is engaged in innovative food research. Its infant food formulation using buffalo milk during the 1960s helped establish the present day's flourishing indigenous baby food industry. And most of the present brands of the ready-to-eat and convenience foods utilize CFTRI's know-how of food science. The institute has close to 350 processes ranging from controlled atmosphere packaging to manufacturing plant growth hormones from agricultural wastes to energy foods for children and weaning mothers-the list is long. And significantly about 70 percent of the export units also use technology developed by CFTRI. The institute has 16 research departments, which focus on the different aspects of food science. The protein chemistry and technology department has developed processes for energy foods. The plant cell biotechnology department focuses on plant biotechnology in the specialized areas of algal biotechnology and tissue/cell culture of plants as also molecular biology and genetic engineering. The fruit and vegetable technology department is working on pre- and post-harvest technologies for extension of storage life and better handling and transportation of fresh fruits and vegetables, low-temperature and modified atmosphere storage of minimally processed vegetables to reduce bulk, minimize spoilage. It also has a strong R&D focus on fermentation through its fermentation technology and bioengineering department. Central Drug Research Institute (CDRI), Lucknow The Central Drug Research Institute (CDRI) is considered to be a pioneer research organization in the field of biomedical research where all the infrastructure and expertise are available to develop a drug right from its concept to market. Latest techniques and methodologies are employed for developing drugs, diagnostics and vaccines to combat diseases prevalent among mankind in general and Indian population in particular. The CDRI is a multidisciplinary research laboratory consisting of scientific personnel from various areas of biomedical sciences. The CDRI has been working on many projects related to the development of new drugs and diagnostics, cellular and molecular studies to understand disease processes and reproductive physiology, development of contraceptive agents and devices, systematic evaluation of medicinal properties of natural products, development of technology for drugs, intermediates and biologicals, dissemination of information in the field of drug research, development and production. To carry out these activities the CDRI has, in recent years, acquired and established best possible technological capabilities and facilities for drug research. The modern facilities are at par, if not superior, to the technologies available at best of the R&D laboratories all over the world. The CDRI focuses on developing new drugs, diagnostics and vaccines and state-of-the-art technologies for clients in India and abroad and associated fundamental research. Industrial Toxicology Research Centre (ITRC), Lucknow Established in 1965, the Industrial Toxicology Research Centre (ITRC), Lucknow, is dedicated to provide health safeguards to industrial and agricultural workers through its rich knowledgebase, created painstakingly over the years. The business of ITRC is to create new knowledge about health and chemicals. It is a unique and important scientific resource in toxicology safety research and testing. The strength of the Centre lies in the knowledgebase and analytical as well as experimental skills built over the last three decades in the areas of health risk assessment, preventive toxicology, predictive toxicology, environmental toxicology, inhalation toxicology and analytical toxicology. The Centre is equipped with state-of-the-art facilities in the field of molecular toxicology and regulatory toxicology and has contributions significant in elucidating the mechanisms by which pesticides, heavy metals, monomers, plasticizers and other plastic additives, solvents, food colours and dye intermediates act and elicit deleterious effects on human health. The laboratory, through its scientific expertise, provides complete facilities for toxicological research, environmental and health risk assessment and analysis and toxicity testing services conforming to Good Laboratory Practices using national and international guidelines employing latest test systems, biomarkers, analytical instruments and mathematical models. Centre for Cellular and Molecular Biology, Hyderabad The Centre for Cellular and Molecular Biology (CCMB) has ongoing research programs in three major categories - high quality basic research in modern biology, research relevant to societal needs, and application-oriented research towards commercialization. These include the areas of biomedicine and diagnostics, evolution and development, gene regulation in prokaryotes and eukaryotes, host-parasite interactions, membrane biology, protein structure, bioinformatics, functional genomics, theoretical biology, etc. The CCMB has established very good industry rapport. It played a key role in the development of the country's first recombinant DNA-based Hepatitis-B vaccine for human use by Shantha Biotechnics. It also helped Dr Reddy's Research Foundation through specific technology tie-ups. A technology about RNasin - an enzyme-inhibitor - was successfully transferred to Bangalore Genei. The CCMB has helped EID Parry by developing a protocol for standardization of PCR-based markers to distinguish the parental and hybrid seed varieties of rice. It has undertaken a collaborative research project with the Dabur Research Foundation and the IICT to develop a new therapeutic agent for the treatment of cancer. In recognition of its contribution to modern biology, the CCMB has been chosen as a Center of Excellence by UNESCO's Global Network for Molecular and Cell Biology, MCBN and has been designated as a South Center for Excellence for Research and Training by the Third World Academy of Sciences (TWAS), Italy. Institute of Genomics and Integrative Biology, New Delhi IGIB is dedicated to frontier areas of genomics. It was established in 1966, as the Center for Biochemical Technology (CBT). To reinforce the efforts to place India on the world map by carrying out cutting edge research, some strategic changes were made by CBT. An important step in this direction was to change the name of the institute to the Institute of Genomics and Integrative Biology (IGIB). This change was in line with the distinctive image of the institute with its new R&D programs such as comparative genomics, proteome analysis, in-silico drug target discovery, novel screens for drug target development, SNP analysis for predictive medicine to develop effective, competitive and commercializable technologies for new drug discovery. The laboratory is working on major projects related to immunology and molecular genetics of respiratory disorders including allergy, fungal infections and predisposition to asthma, molecular genetics of neuro-psycho disorders and functional significance of repetitive sequences in the genome, genome informatics and drug target identification. IGIB is also working on the development of molecular markers for pathogenic organisms, including Mycobacterium tuberculosis, molecular recognition/interaction studies, design and synthesis of modified oligonucleotides for antisense and gene targets and design, synthesis and structural studies of peptides with a role in neurological function and dysfunctions. National Botanical Research Institute (NBRI), Lucknow NBRI has produced innumerable varieties in horticulture, products as functional foods and filed almost 30 patents in India and abroad. Today, it is an internationally known research center that focuses on both basic and applied research in various aspects of plant sciences for the conservation and sustainable utilization of plant genetic resources for human welfare. Offering consultancy and technology, today, it caters to the needs of every aspect of plant research in the South Asian region in general and India in particular. In that mission, its practices encompass biodiversity, bioinformatics, biomass biology, biotechnology, conservation, ethnopharmacology, floriculture, plant physiology, genetics and plant breeding, molecular biology and genetic engineering, natural product development, etc. NBRI is rich in scientists and knowledge base. For instance, Dr Rakesh Tulli and his group work in the area of plant molecular biology. Dr Tulli commented, "The main objective of our work is to develop transgenic plants improved for agronomically important characters. Characterization and designing of genes for toxicity to insects is also a part of our research. Apart from these, we also offer consultation and contract research for the biotech industry." NBRI is actively involved in making a "Passport Data of Important Wild Genetic Resources" with reference to their aromatic and herbal values. Central Institute of Aromatic and Medicinal Plants, Lucknow Cutting edge technologies, innovative ideas and societal needs are the priority focus areas at CIMAP. Broadly the research areas at CIMAP pertain to scientific and industrial facets of medicinal, aromatic and other important natural product yielding plants-right from development of new varieties to processing and marketing thereof. Development of agro technologies and chemical and processing technologies for economically important medicinal and aromatic plants, both indigenous and exotic, is an important goal of the institute. Basic research in the areas of genetic resources, biotechnology, cytogenetics, phytochemistry, plant physiology, biochemistry, plant protection, pharmacognosy and molecular biology forms an important and integral part of the overall R&D program of the institute. CIMAP's "Plant Geranium project" is one of its most important ongoing activities. Experiments conducted by CIMAP have suggested that it can be successfully cultivated in Uttranchal on an economical basis. Further, CIMAP is proud of its national gene bank for medicinal and aromatic plants, which comprises medicinal and aromatic plants herbarium, conservatory, gene banking and repositories of extracts and chemicals supported by the CSIR and DBT. National Chemical Laboratory (NCL), Pune NCL started five decades ago with the purpose to advance knowledge and to apply chemical sciences for the good of people. The laboratory over the years has forged strong industrial and academic collaborations in pursuit of its objectives. It works closely with many international companies and over 50 Indian companies. The biotechnology group at the laboratory is a multidisciplinary and multi-skill R&D group with interest in the area of biochemistry, molecular biology, microbiology, botany, and biochemical engineering. It is supported by the state-of-the-art experimental facilities, large-scale pilot plants for plant tissue culture, and scaled up facilities for microbial processes and downstream separation. The laboratory's strong knowledge base has established its competency in taking up projects in the areas like plant molecular biology and agricultural biotechnology, plant tissue culture and microbiology, and enzyme technology. In addition to taking up the projects, its process development and design activity provides the vital link for translating a laboratory process to a commercial plant. A team of chemists, technologists, and engineers work together in achieving this task. The process technologies developed and implemented encompass a variety of areas like catalytic and non-catalytic processes involving esterification, hydrogenation, oxidation, acylation, chlorination, fermentation as well as polymerization. National Environmental Engineering Research Institute (NEERI), Nagpur The focus of research at NEERI is on environmental biotechnology and genomics for designing user-friendly products/technologies to control pollution. It was established in 1958, as Central Public Health Engineering Research Institute (CPHERI) and was renamed in 1974 as National Environmental Engineering Research Institute (NEERI). The main campus at Nagpur is spread over 108 acres where the laboratory buildings and demonstration plants are located. Green stretches of land are liberally scattered over the campus and nearly 40 percent of the land is under forest cover. The institute has made significant contributions in identified thrust areas of R&D, viz. environmental monitoring, environmental biotechnology, hazardous waste management, environmental systems design, modeling and optimization, environmental impact and risk assessment and audit and environmental policy analysis. The mix of activities includes sponsored research projects, developmental projects and in-house research projects. The institute has a library and documentation division, which is an established specialized information resource centre for environmental science and engineering in the country. It provides vital scientific information support to the R&D activities of the Institute. Institute of Microbial Technology (IMT), Chandigarh IMT, Chandigarh carries out focused R&D programs in four broad areas of microbial biotechnology: molecular biology and microbial genetics; protein science and engineering; fermentation technology and applied microbiology; and cell biology and immunology. The institute has an International Depository Authority (IDA) facility and has a collection of 10,000 microbes and more than 13,500 cultures have been supplied to the academic and research institutes and the industry. Its Microbial Type Culture Collection holds 70 cultures for IDA deposit, 96 for filing national patents and 9 under safe deposit. The Institute has collaborative research programs with several institutions both at national and international levels and several of its process technologies have been commercialized. The most successful of them is a branded Natural Streptokinase product, 'STPase'. The other know-hows commercialized are: Energy Efficient Alcohol Technology and a vaccine prediction software tool 'Vaxipred'. Speaking about the future technology pipeline at the institute, Dr Girish Sahni, director IMTECH, said, "In the future one of our technologies on the production of Recombinant Streptokinase and the other on Clot Specific Streptokinase are expected to be launched soon. We plan to commercialize an immunodiagnostic technology and an oral recombinant cholera vaccine as well. We have an ongoing program on generating more efficient strains of yeast, which would incorporate properties of flocculation, thermo- and osmotolerance. This is an ongoing program wherein several yeast strains with improved properties have been designed and patented." ]]> <![CDATA[Ocimum Biosolutions Ltd.]]> https://biospectrumindia.com/news/95/2046/ocimum-biosolutions-ltd-.html https://biospectrumindia.com/news/95/2046/ocimum-biosolutions-ltd-.html Wed, 11 Jan 2006 14:12:00 +0530 Ocimum Biosolutions Ltd Ocimum Biosolutions Ltd. Anuradha Acharya Hyderabad-based Ocimum Biosolutions is a BioIT and contract research and development company with competencies in LIMS, bioinformatics, genomics tools and custom contract research services, with operations in the US and India with support from partners in Europe and Canada. Besides customers in India, Ocimum has over 100 customers across the world. Besides pharma and agricultural organizations, Ocimum serves biological and non-biological research organizations, individuals and organizations working in the area of Microarrays. The BioIT division of Ocimum Biosolutions specializes in ready-to-use reliable, cost-effective software solutions for the biotech and pharma industry with a suite of LIMS and bioinformatics products such as Biotracker, Toxchek, Pharmatracker, Genchek, OptGene, Nutrabase, Genowiz and iRNAchek. With the acquisition of the Microarray division of MWG Biotech, Germany, in 2004, Ocimum launched a whole suite of microarray products. "These include Catalog OciChips, Custom OciChips and hybridization services. With this acquisition, Ocimum offers a complete microarray portfolio for academic and industry customers," said Anuradha Acharya, CEO, Ocimum. Address: Ocimum Biosolutions Ltd. 6th Floor, Reliance Classic Road No 1, Banjara Hills Hyderabad - 500 034 Andra Pradesh Tel.: +91 40 5562 7200 Fax: +91 40 5562 7205 Website: www.ocimumbio.com ReaMetrix Bala S Manian ReaMetrix is a company founded by successful serial entrepreneur Bala S Manian to leverage the Indo-US corridor. It has a different business model. "What we are saying to our customers is that we would be totally transparent about what our costs are. Your skin in the game is that you pay for our incremental costs, not for our capital costs, which we have already sunk in. But we want a share of the value that we are creating. For every project we are doing we either get a share of the revenue on an ongoing basis or we get certain rights to the technology that we can then monetize for other applications," said Manian, director, ReaMetrix. The company has announced a critical diagnostic product for managing HIV patients, Accuford TriTStat. The product has been developed keeping in mind the local conditions and affordability in mind. The product is expected to create a revolution in managing HIV patients by bringing down the cost of tests by a factor of five. Next in line is an alternative to viral load, a molecular biology test that today requires PCR and complex instrumentation, control conditions. "We are trying to find an alternative approach to provide the same clinical information so that the combination of Tri-TStat plus the viral load allows us to meet the cost rules set by the Davos conference in 2005 in Switzerland where they said we would like the testing burden, part of the test (two tests a year) should be in the $50-$60 range," informed Manian. Address: ReMetrix India Pvt Ltd # 50-B, II Phase (Near TVS Cross), Peenya Industrial Area, Peenya, Bangalore â€“ 560 058 Tel.: +91-80-28378693/5 Fax: +91-80-51172451 Website: www.reametrix.com Syngene International Dr Goutam Das A subsidiary of Biocon, Syngene offers customized R&D services to the pharmaceutical and biotechnology sectors in early stage drug discovery and development. It was one of the first CRO companies in India. It has two divisions - molecular biology and synthetic chemistry. The molecular biology division has developed a strong infrastructure and expertise to handle alkyl lithiums, air and moisture sensitive reagents, reactions under inert conditions and metal mediated reactions. The contract research services from Syngene and Clinigene, another Biocon subsidiary have registered a 35 percent growth over Q1 FY-2005. Syngene has procured new research contracts from both existing and new customers, which will translate into incremental revenues for this fiscal. Its clients include 6 of the top 10 global pharma majors. Kiran Mazumdar-Shaw, CMD, Biocon Ltd, said, "The outlook for the year ahead remains positive. New research contracts both at Syngene and Clinigene will deliver additional growth. The new capacities that will come on stream in the latter half of this fiscal will also contribute to overall growth." Syngene was awarded the Certificate of Excellence for Export Achievement by the Government of India, for two consecutive years 2002-2003. Address: Syngene International 20th KM Hosur Road, Electronics City Bangalore 560 100 Tel.: 91 80 2808 2808 Fax: 91 80 2852 3423 Website: www.biocon.com SIRO Clinpharm Pvt Ltd Siro Clinpharm Pvt Ltd, one of the earliest entrants in the contract clinical research business in India having commenced operations in 1996, has steadily built its reputation as a specialist in late stage clinical development solutions. With 5,000 subjects recruited in 45 studies across a wide spectrum of therapeutic indications, SIRO has grown organically, gradually building capabilities in all areas of Phase II, III and IV clinical trials. Under the leadership of Dr Gautam Daftary, who has over 20 years of experience in pharmaceutical management, SIRO is supported by a global advisory board that has been instrumental in structuring the company into the leading contract research organizations in India. According to Dr Chetan Tamhankar, general manager, SIRO Clinpharm, the company has entered into tie-up with Pfizer Global Research and Development, through its affiliate in India to cover the provision of clinical data management and biometrics services. SIRO has entered into strategic partnership with Spacelabs Medical Data. "Through this alliance, SIRO will offer centralized cardiac safety monitoring services including centralized ECG, Holter and Ambulatory Blood Pressure Monitoring services to any of the clinical studies that it manages in India," added Tamhankar. Besides, with Covance Inc. of Princeton, New Jersey, SIRO has been offering pharma development services in India in support of the domestic and international biopharmaceutical industry. Address: SIRO Clinpharm Pvt. Ltd. 106, 10th floor, Lady Ratan Tata Medical and Research Centre, 31, Maharshi Karve Marg, Cooperage, Mumbai - 400 021. Tel.: +91-22-2284 4011/3832/1311/1711 Fax: +91-22-2284 4169/ 2288 5791 Website: www.siroindia.com Strand Life Sciences Prof. Vijay Chandru Strand Life Sciences, formerly Strand Genomics, is a premier in silico technologies innovation company. It is focused on developing technologies for drug discovery and development. Strand has three streams of business spanning early target discovery through pre-clinical development. The first is centered on informatics tools and solutions for the research biologist with a focus on visualization and analytics for array technologies and including oligo design, image analysis and information management systems. A second stream of products include a cheminformatics modeling platform Admetis and proprietary in silico predictive models for small molecule drug properties like ADME and cardiotoxicity with models for hepatotoxicity in the pipeline. Strand also partners with discovery contract research companies to combine in silico and wet labs to offer services starting from compound library design to lead generation. Strand leverages its core strengths in data mining, predictive modeling, computational chemistry, software engineering and research biology to develop technologies and products for research biology and drug discovery. In December 2005, Strand struck a strategic partnership with the US-based Stratagene Corporation to develop a suite of next generation bioinformatics software tools. Both the companies will collaborate on the design and development of innovative software tools to address the increasingly complex demands of biological data analysis for life scientists. The company has also entered into a research collaboration with Elan Pharmaceuticals aimed towards supporting Elan's drug discovery efforts. Strand's award winning Avadis software application has recently achieved GeneChip-compatible status with the Affymetrix Inc. GeneChip microarray platform and has joined the Affymetrix GeneChip-compatible Applications Program, which provides customers with a broad spectrum of software solutions for biomedical research and development. Address: Strand Life Sciences 237, Sir CV Raman Avenue, Rajmahal Vilas, Bangalore-560080 Tel.: +91-80-23618992, 23618993 Fax: +91-80-23618996 Website: www.strandgenomics.com Triesta Sciences Triesta Sciences is a privately owned clinical genomics company based in Menlo Park, CA and Bangalore, India. It was founded in early 2002 by a group of US-based clinicians and scientists of Indian origin. The company leverages the Indian clinical substrate to address a key research bottleneck; the clinical validation of genomics derived products of therapeutic and diagnostic utility. Triesta undertakes clinical and molecular evaluation and validation of new targets and markers in partnership with international diagnostics and pharmaceutical companies. The company has disease programs in the areas of oncology, infectious diseases, gastrointestinal disorders and renal disease. Its current programs include: retrospective studies to evaluate tissue molecular markers of drug response in breast cancers; and prospective studies to evaluate markers of disease staging and drug response in colorectal and breast cancers. Triesta has established integrated clinical research and molecular analysis capabilities in India to undertake the end-to-end clinical validation of novel RNA, DNA or protein based targets and markers. The company entered into a strategic alliance with Molecular Connections in the area of biomarker discovery and validation in 2003. As a part of the alliance, Molecular Connections will provide its advanced information extraction, informatics and pathway analysis expertise for Triesta Sciences' biomarker discovery program. Address: Triesta Sciences 133/134, Raheja Arcade, Koramangala Industrial Estate, Bangalore-560095 Tel: +91-80-56670005 Website: www.triestasciences.com XCyton Diagnostics BV Ravikumar Bangalore-based XCyton Diagnostics Ltd was started in 1993 with a mission to develop, manufacture and market diagnostic kits for infectious diseases. The company developed the country's first indigenous kit to detect antibodies to HIV 1 and 2 called HIV-CheX. It introduced its second product, a detection kit for a parasite, neurocysticercosis, in the brain in the year 2000, called CYSTI-CheX. The third product, HEPCheX, a Hepatitis detection kit, was launched in 2001. And in 2004, it launched JEVCheX a detection kit for Japanese Encephalitis. A prominent diagnostic player, the kits developed by XCyton are in the list of kits approved for usage in blood banks by the Drug Controller General of India. Its HIV-CheX kit is in the bulk purchase list of the World Health Organization (WHO) and is purchased by WHO. For developing new technologies and products, it has strong technical collaborations with premier institutes in India such as IISc, Bangalore, NIMHANS, Bangalore, ICGEB, Delhi, TRC Chennai, AIIMS, New Delhi, DRDE, Gwalior, Vipra Inc. USA. According Dr B Ravi Kumar, managing director, XCyton, the company is working on developing a dengue kit, vision chip, a chip for detecting the infection of the eye, and spot tests for HIV, HCV, etc. Address: 15/3, Jyothi Industrial Complex, Abbigere Main Road, KG Halli, Bangalore â€“ 560 015 Tel.: +91-80-23452913, 28388845 Virchow Biotech (P) Ltd Virchow Biotech (P) Ltd, one of the group companies of the Virchow group of companies has received the green signal from the Genetic Engineering Approval Committee (GEAC) to conduct clinical trials with VIRKINASE - a recombinant Streptokinase that it has developed indigenously. The company proposes to conduct a multi-centric randomized double-blind study in a total number of 75-100 subjects aged between 18-75 years with acute myocardial infraction fulfilling the eligibility criteria. The clinical trials will be conducted at five CARE Hospitals in Hyderabad. It has already out-licensed its first product, Recombinant Human Platelet Derived Growth Factor (rhPDGF) to Dr Reddy's Labs, which is marketing it under the brand Plermin, prescribed for diabetic foot ulcer. Virchow Biotech has been working on 10 new products, mostly recombinant products. Besides doing research, it is in the process of setting up a manufacturing facility for rDNA biopharmaceuticals. Of the four patents filed so far, Virchow Biotech has received one patent approval. It has launched 'Bioflora', a product indicated for the prevention of diarrhoea, irritable bowel syndrome, antibiotic associated diarrhoea, diarrhoea during enteral feeding, traveller's diarrhoea. Virchow Biotech is also to launch 'Hyopt', a viscoelastic product to aid cataract surgeries. It can be useful in intra and extra capsular cataract extraction, IOL implantation, corneal transplantation. Being a naturally occurring polysaccharide, Sodium Hyaluronate present in Hyopt has no serious side effects except for a transient rise in intra-ocular pressure. It is supplied in dispensable pre-filled syringes as a sterile viscous liquid for single patient use. "We have pipeline of products. We hope growth in biotechnology is promising and will grow with growth of the biotechnology industry," said Dr Hemanth Nandigala, executive director - commercials, Virchow Biotech Pvt Ltd. Virchow Biotech is a part of the pharmaceutical group company - Virchow group of companies that also focuses on biotechnology. The group has a US FDA approved unit in Jeedimetla (Hyderabad) that manufactures Sulfamethaxozole. Address: Virchow Biotech (P) Ltd Plot No: 4 SV Cooperative Industrial Est. I.D.A. Jeedimetla Hyderabad â€“ 55 Tel.: +91-40-2309 6688, 5519 4226 Fax: +91-40-2309 6677, 2309 5053 ]]> <![CDATA[Jubilant Biosys]]> https://biospectrumindia.com/news/95/6235/jubilant-biosys.html https://biospectrumindia.com/news/95/6235/jubilant-biosys.html Wed, 11 Jan 2006 14:10:00 +0530 Jubilant Biosys Jubilant Biosys Jubilant Biosys is an innovative bio-informatics and chemo-informatics service provider, which started its operations in November 2003. The company has made significant inroads into the global market place and has entered into multiple engagements with leading R&D and pharmaceutical organizations. Jubilant Biosys currently has more than 32 international customers, of which seven are pharmaceutical companies and eight are in the biotechnology sector. During the fiscal 2004, it became a subsidiary of Jubilant Organosys and its activities complement Jubilant Organosys' focus on the pharmaceutical and life sciences market, creating a potential for greater synergies. "Jubilant Biosys specializes in providing high quality databases and informatics solutions to meet the R&D requirements of leading pharmaceutical and biotechnology companies globally," informed VN Balaji, chief scientific officer, Jubilant Biosys. Located at Bangalore, employing over 250 researchers and scientists and spread over an office area of 25,000 sq ft, it is recognized by the Department of Science and Industrial research (DSIR) as an R&D company. It focuses on providing bioinformatics research services throughout the drug discovery and development process, and has a modern bio and chemo informatics center, including a software development facility for aiding biotechnology research. Jubilant Biosys has further developed its innovative knowledge-based products that provide bio and chemo-informatics services during fiscal 2004. Some of these products are Kinase ChemBioBase, GPCR Annotator, Caspase database, Pathways database, Nitrilase and Nitrile Hydratase database. During FY 2004, Jubilant Biosys successfully initiated engagements with leading global pharmaceutical and research organizations. One of the world's largest pharma majors, Novartis, licensed PathArt from Jubilant Biosys. Novartis will be leveraging PathArt in its global drug discovery programs. Jubilant Biosys also licensed PathArt to The Systems Biology Institute, Tokyo, which would help their researchers generate better systems biology models. Address: Jubilant Biosys Ltd. 450 Twelfth Cross, 4-DMain, Mahalakshmipuram, Bangalore-560086 Tel.: +91-80-23495461 to 65 Fax: +91-80-23494118 Website: www.jubilantbiosys.com Labland Biotechs Pvt Ltd Labland Biotechs, floated in the year 1994, has a fully equipped laboratory at Mysore. Labland is entering into a new phase in its business mission and diversifying its activities into biodiesel. Labland has firmed up two long-term contracts with an UK-based D1 Oils for the supply of tissue cultured jatropha plants and jatropha seed-derived crude oil respectively. Under the long-term contract with D1 Oils, it will supply one crore jatropha plants produced through tissue culture every year for the next 10 years for global distribution. To promote jatropha-based biodiesel program in rural areas, Labland has signed a Memorandum of Understanding with Sahyadri Science College, Kuvempu University, Shimoga in Karnataka. With this, Sahyadri Science College became the first to act as Jatropha Information and Dissemination Centre. "Indian farmers are expected to have sustainable benefit from the scheme since the biodiesel requirements are likely to go up in the coming years in the country and overseas," said Dr Sudheer A Shetty, managing director, Labland Biotechs. Besides plant biotechnology Labland has entered pharma biotech by taking 26 percent stakes in Neobiotics India Pvt Ltd, a pharma biotech company in Canada. With this partnership, Labland has strengthened its activity in the areas of pharma biotech, contract research, and biotech training. Address: Labland Biotechs Pvt Ltd Plant Tissue Culture 8th KM, KRS Main Road Mysore - 570 016, Karnataka. Tel.: +91-821-2582682/5288828 Fax: +91-821-5288818 Website: www.lablandbiotechs.com Manipal AcuNova DA Prasanna Manipal AcuNova, a Bangalore-based contract research organization, is a collaborative venture between the Manipal Education and Medical Group International India Pvt Ltd and AcuNova Life Sciences Pvt Ltd. Set up in 2005, this CRO has four lines of business. "One, we are the business development arm for discovery research for Manipal Group and also a sponsor. Two, conduct clinical research, mostly in the clinical development phase from Phase 1 to Phase 3 at Manipal and non-Manipal sites. The third area of activity is a clinical reference lab with advanced molecular diagnostics lab. This is coming up in Bangalore. The fourth division is into clinical data management," informed DA Prasanna, vice-chairman and managing director, Manipal AcuNova. Manipal AcuNova has recently raised Rs 45 crore. It currently has three research centers and is looking at setting up another research center in either Hyderabad, Chennai or Mumbai. "Establishing a clinical reference lab and expanding client capabilities in the US and UK, where the company has subsidiaries, are also on the cards," said Prasanna. The company was conferred the title of "India's best emerging CRO" in a survey conducted by Proximare, a New Jersey-based management consulting firm that develops and implements growth strategies for pharmaceutical and biotech companies. Address: Manipal AcuNova Manipal Towers, 14 Airport Road, Bangalore-560008 Tel.: +91-80-25217617/18 Fax: +91-80-25217619 Website: www.acunovalife.com Metahelix Life Sciences Dr KK Narayanan Metahelix is an agri-biotech company focused on developing technologies for crop improvement. The company partners with agri-biotech and seed companies and offers services in the areas of functional genomics, plant genetic transformation, trait development and marker assisted crop improvement. Metahelix was set up in 2000 by five scientist-turned-entrepreneurs. Till date, an amount of over Rs 9 crore has so far been spent on research facilities and personnel. Its scientists have core capabilities in plant genomics and informatics combined with vast experience in the genetic transformation of corn, cotton, rice and several vegetable species. Metahelix has partnerships with seed companies and is focused on developing new and novel crop varieties using biotechnology. In 2003, Metahelix signed a four-year plant functional genomics research agreement with Vialactia Biosciences Ltd, a New Zealand-based diary biotech company. The program involves the functional validation of a large number of genes from pasture plants, potentially leading to improved plant varieties of pasture and crop plants. Vialactia and Metahelix intend to use the knowledge from ViaLactia's ryegrass functional genomics program to develop commercial rice varieties in India through Dhaanya Seeds, a subsidiary seed production and marketing company of Metahelix. Address: Metahelix Life Sciences Pvt. Ltd Plot No. 3, KIADB 4th Phase, Bommasandra Industrial Area, Bangalore - 562 158 Tel. : +91-80-783 6086 Fax : +91-80-783 6084 Website: www.meta-helix.com Molecular Connections Molecular Connections headquartered in Bangalore, is a joint venture between Idea2solutions Pvt Ltd, an incubator promoted by the founders of the Dr Reddy's group and Laboratories for Information Technology, Singapore, a national research institute for advanced technologies. The focus of the company is to build products and provide services to enhance efficiency, reduce the discovery cycle time and minimize the resources spent by drug discovery companies. One of its important accomplishments is the NetPro, a proprietary protein interaction knowledge base, which covers expert, curated and annotated protein-protein interactions from published biomedical literature. All molecules in NetProTM are linked to public Ids (like LocusLink), facilitating ready integration of interactions information into proprietary databases. The protein-protein interactions in NetProTM are complemented with annotations of the profiled proteins with scientific literature information on a variety of important subjects. Molecular Connections has licensed NetPro to global players like Lion Bioscience Research Inc and GSK. Currently the company has about seven major client spread across the US, Europe and the Far East. Its varied client base has helped the company in consolidating its exposure in Europe and the US. It has also licensed the protein interaction database to a research lab at DOE Institute for Genomics and Proteomics, UCLA. Molecular Connections has offices in Bangalore, India and Gaithersburg, Maryland. Address: Molecular Connections # 26/1, 24th Main, 5th Phase, JP Nagar, Bangalore â€“ 560078 Tel.: +91-80-26595216 Fax: +91-80-26596101 Website: www.molecularconnections.com Monad Nanotech Pvt Ltd Monad Nanotech is the first Indian company to produce carbon nano materials (CNM) at a commercial level using low cost production technology developed by Prof. Maheswar Sharon's group at IIT Mumbai, who has two patents and 38 research publications to his credit on carbon nano materials. Prof. Sharon, a pioneer in CNM research in India along with his wife Dr Madhuri Sharon, ex-director - plant biotechnology, Reliance Life Sciences, started Monad Nanotech Pvt Ltd in January 2004. Now it has filed two more patents. The R&D activities at Monad Nanotech are lead by Prof. Sharon. The team has been working on not only synthesis of carbon nano material but also on their futuristic applications. Prof Sharon was the first scientist to use plant-based precursors for synthesis of CNM, the idea being that plant based precursor unlike petroleum-based precursors could be harvested as and when desired. Their first attempt was made with camphor, which is synthesized from the resin of pine tree. Now they expanded their choice to various other non-edible oils. They have been able to synthesize almost all forms of carbon nanomaterials, which have been synthesized by conventional route. Utilizing the rich experience and technologies developed by Prof Sharon, Monad Nanotech with a small team of 10 scientists had come out with 13 products. The company uses plant-based raw material for the production of various types of CNM rather than expensive fast depleting fossil fuels. Monad Nanotech has been supplying many nano materials to the research organizations in India. The products include MWCNT1-3 nano beads 1-2, nano fibers 1-4, fibrous carbon nano size metals and porous carbon gas diffusion fuel cell electrodes at less price Rs 100-500 /gram based on the purity of the product. The nano materials in the international market, are available at $80 /gram (Rs 3600 / gram taking one $one = Rs 45). "Being the first generation nanotechnologists we have limitation. But combining research with commercial activities we will grow, inspite of depending on international orders," said Dr Maduri Sharon, managing director, Monad Nanotech Pvt Ltd. Address: Monad Nanotech Pvt Ltd A-702, Bhawani Towers, Adishankaracharya Marg, Opposite IIT Main Gate, Powai Mumbai - 400076 Telefax: +91-22-25790633 Website: www.monadnano.com Reliance Life Sciences Pvt Ltd Mukesh Ambani Reliance Life Sciences (RLS) is a millennium initiative of the Reliance Group. The Group initially has invested $5 million in setting up facilities in cell biology in Mumbai. And the embryonic stem cell work began in April 2001. The Reliance Industries Ltd will be investing about $25 million in cell biology research to focus on stem cells and tissue engineering. This covers embryonic stem cells, haematopoietic stem cells, skin cells, tissue engineering, genetics and molecular diagnostics. RLS' facility at Jamnagar primarily focuses on plant biotechnology projects where modern farming methods are being tried in arid areas. In addition to this, Jamnagar also has facilities for carrying out industrial biotechnology research by addressing the biopolymers, biofuels and bioprocess development opportunities. Besides stem cell research, RLS is developing business opportunities in the domains of medical biotechnology, plant biotechnology, industrial biotechnology, contract research and clinical trials. RLS is in the process of setting up its Cord Blood Repository (CBR) and plans to grow the repository to around 30,000 units over the next two-three years. It has filed about nine patents in India and has been offering few products and services in both medical and plant biotechnology space. With a strong team of scientists and researchers numbering over 100, it already has products and services in medical biotech such as ReliCord, ImmunoRel, AlbuRel, and ReliSeal. Reliance Industries Ltd has set 2009-10 as a threshold year to emerge as a global energy major. To achieve this, life sciences has been identified as its next major initiative. While addressing the company shareholders in August 2005, Mukesh Ambani, chairman and managing director, Reliance Industries Ltd who also heads the Reliance Life Sciences said, "I would like to take you into confidence on the broad contours of areas that Reliance Industries Ltd would explore and engage. Life Sciences is our next major initiative." Address: Reliance Life Sciences Pvt Ltd Dhirubhai Ambani Life Sciences Centre, R 282 TTC Area of MIDC, Thane-Belapur Road, Rabale, Navi Mumbai - 400 701, Tel.: +91-22-3911 8000 Fax: +91-22-3911 8099 Website: www.relbio.com ]]> <![CDATA[Companies to Watch Out for in 2006]]> https://biospectrumindia.com/news/95/2222/companies-to-watch-out-for-in-2006.html https://biospectrumindia.com/news/95/2222/companies-to-watch-out-for-in-2006.html Wed, 11 Jan 2006 14:04:00 +0530 Companies to Watch Out for in 2006 Companies to Watch Out for in 2006 The biotech industry in India like elsewhere in the world is characterized by small and medium size companies. However, the difference ends there. The Indian start-ups are confronted with the inadequate availability of venture capital or seed capital. They are struck for want of an atmosphere, which has led to spin out of companies from R&D institutes. The industry is nascent and regulatory mechanisms are on the path of being streamlined. Despite all these, India is a very attractive destination for the availability of low-priced human capital and skilled labor. It's a mature market, feel several of the leading global chief executives. They see India as a place from where a next Amgen will emerge. Reason: Indian companies have adopted to the challenging environments and learnt to develop business models that start bringing in revenues from the first year of operation itself. Indian biotech companies have focused on services, R&D, and product development as a way out to sustain and grow. Companies here have already set their sight as global companies with local presence. They are using the Indo-global corridor, more specifically the Indo-US corridor as the progression path. Also the Indian pharma industry is quite mature and provides a conducive feeder environment. In the ensuing pages, we present to you the companies we feel will hit the news headlines. We have deliberately not listed big and well-established companies like Biocon, Bharat Biotech, Lotus Labs, Serum Institute of India, Shantha Biotech, and Vimta Labs. All these today are the flag bearers of India's biotech march and they will certainly be doing well. We have focused on the companies that will make a difference in the next level of India's biotech march. Interestingly, most of them have a services offering and product development path. And some of them will be big global companies. Read on. ABL Biotechnologies Ltd KO Isaac Incorporated as a private limited company in 1992, ABL Biotechnologies Ltd exported its first consignment of Frozen Sea Food to Spain and Japan in 1993. During the same year, it diversified its operations into infrastructure support services for aquaculture by supplying aquaculture equipment and inputs to numerous aqua farms. It entered into long-term agreements with several international companies of repute and became public limited company in 1994. Since then the company has diversified its activities into high technology aquaculture and biotechnology research. ABL has set up a research and development facility at Vishakapatnam, one of its kind and the only such facility in the private sector in India to be accorded accreditation and recognition by the Department of Scientific and Industrial Research (DSIR). The Microbial Metabolites Laboratory at Chennai works on evaluating new sources of biochemicals from marine organisms. ABL's present focus includes work on pharmaceuticals like anti-bacterials and anti-virals, enzymes, bio-molecular materials, bio-monitors and diagnostics, bio-pesticides, bioremediation and aquaculture. According to KO Isaac, MD, ABL Biotechnologies, 6 marine microbe products are ready for production and two products, Docosahexaenoic Acid (DHA) and phycocyanin production will start in 2006. Address: ABL Biotechnologies Ltd No.55, Third East Street, Kamaraj Nagar, Tiruvanmiyur, Chennai â€“ 600 041. Tel.: +91 44 52020501/ 52020502. Fax: +91 44 52020957. Website: www.ablbiotechnologies.com ClinInvent Research Pvt Ltd Dr Arun Bhatt ClinInvent Research is a full-fledged Contract Research Organization (CRO), which provides comprehensive services for complete clinical trial management. Within a short existence of over 20 months, it has established business relationships with leading pharmaceutical companies. The company has a tie-up with MDS Pharma and is its preferred CRO for India. ClinInvent has set up facilities to provide end-to-end capabilities in clinical trails management. Recently it has implemented Oracle Clinical software for data management. The company has completed trials in the tropical diseases segment, for a new diagnostic test for malaria. It has commenced phase III clinical trials on a respiratory product for an Indian company, but for international submission and is in the process of conducting Phase III trials on an ophthalmology product for a subsidiary of a multinational company. Similarly trials are to commence on a cardiology product, an oncology drug and an anti-fungal product. It has 50 researchers working at different areas like quality assurance, regulatory affairs, clinical data management and statistics, clinical trial supplies management and pharmacovigilance. "We have significant opportunities of participation in global clinical trials. We are an young CRO, which is making steady and solid progress by gaining the confidence of global clients," said Dr Arun Bhatt, president, ClinInvent Research. Address: A-302, Everest Chambers, Next to Star TV office, Marol Naka, Andheri-Kurla Road, Andheri (E), Mumbai â€“ 400059 Tel.: +91-22-28511860, 28595101 Fax: +91-22-28515482 Website: www.clininvent.com Dabur Research Foundation Dr Anand C Burman Dabur Research Foundation (DRF) is active in the area of developing and screening New Chemical Entities (NCEs), novel drug delivery systems and generic molecules. It has also initiated work in developing biotechnology-based products. The foundation is at present involved in the development of biotherapeutics especially cancer vaccines and is also active in the areas of genomics, proteomics and molecular diagnostics. Dabur Research Foundation is developing both therapeutic and prophylactic vaccines, which will target adenocarcinomas and squamous cell carcinomas. According to Dr Rama Mukherjee, president (R&D), Dabur Research Foundation, the main objective of the approach is to provide a disease-free state after the primary therapy and protect high-risk individuals with genetic predisposition and also protect individuals with evidence of pre-neoplastic lesions. One of the major products in the pipeline is a multivalent synthetic vaccine, which targets antigens over expressed in tumor cells. The vaccine is expected to bring about a cytotoxic T lymphocyte and natural killer cell response and leads to tumor regression. The biomolecule is in preclinical stage of development and is expected to go into the clinical trials by the end of 2008. Address: Dabur Research Foundation 22, Site IV, Sahibabad, Ghaziabad-201010 Tel.: +91-120-2778501-25 Fax: +91-120-2777303 Website: www.dabur.com GangaGen Biotechnologies GangaGen Biotechnologies is a biotechnology company focused on the development of bacteriophage-based products for prevention and treatment of bacterial infections, which has received two US patents for its proprietary bacteriophage technologies "Lysin-Deficient Bacteriophages with Reduced Immunogenicity" and "Incapacitated Whole-Cell Immunogenic Compositions." It has presence in India, the US and Canada. According to Dr Janaki Ramachandran, president, GangaGen Biotechnologies, the company's scientists knocked out the phage gene that codes for the Lysin enzyme responsible for breaking down the bacterial wall and produced a Lysin-deficient bacteriophage that kills the bacterial host, undergoes one cycle of replication but remains inside the dead bacterium. "Lysin-deficient bacteriophage retain their specificity, kill the pathogenic bacterial host rapidly, but do not cause lysis (breakdown of the bacterial cell wall) and are not released into the patient or the environment. Lysin-deficient phages also permit linear dosing like antibiotics," he said. The second patent is a logical sequel to the first patent. It enables the development of highly effective vaccine to protect against any bacterial infection in man or animals. GangaGen Biotechnologies Pvt Ltd (GBPL) is developing proprietary phage products to treat infections caused by staphylococcus bacteria, including nasal, urinary tract, and pseudomonas aeruginosa infection in burns and wounds. Founded by Dr J Ramachandran in 2000 with an investment of $5 million, GangaGen plans to mobilize another $5 million. Address: # 5 AC, 705 II Block, Hennur Road, Banaswadi Layout, Bangalore â€“ 560 043 Tel.: +91-80-25448138/25448146 Fax: +91-80-25447996 Website: www.gangagen.com GVK Biosciences Pvt Ltd Hyderabad-based CRO, GVK Biosciences, which started in 2002, has expanded its activities in the last three years and today offers services and collaborative research basis to bio-pharma companies globally in areas including medicinal chemistry, process chemistry, biology, informatics, clinical research, bioanalytical and bioavailability (BA/BE) services and knowledge process outsourcing. The BA/BE division received accreditation by ANVISA, the Brazilian Regulatory and Health Authority. GVK BIO was selected as the "Best Indian CRO for 2005" in the Drug Discovery Services category, by Proximare, one of the management consulting firms that develops and implements growth strategies for pharmaceutical, biotech and related industries. DS Brar, chairman, GVK BIO said, "It is a big step forward in a short time" for the company. Davinder Singh Brar, left Ranbaxy Laboratories in 2004 and turned a pharma venture capitalist, and has made a substantial investment in the Sanjay Reddy-promoted GVK BIO and is heading the company as chairman. GVK BIO has staff strength of 800 employees, of which 85 percent are scientists and currently has around 100,000 sq.ft. of laboratory space and will be investing Rs 60 crore by middle of 2006 to enhance its operations, including research and development, human resources and IT. Recently it announced the acquisition of the Dai-ichi facility at Nacharam, Hyderabad. In this joint venture, GVK BIO and associates will hold 80 percent equity and would operate under the name of Inogent Laboratories Pvt Ltd (Inogent Labs). Inogent would be engaged in the business of APIs, process chemistry, custom synthesis of NCEs and custom manufacture for chemical entities. It also offers biotechnology and pharma patent drafting and patent search outsourcing services in association with TMPSearchers, a patent search and drafting firm. This is the first time in India a patent search and drafting firm and a major contract research service provider have joined hands to offer patent search, patent drafting and allied services jointly bringing both legal and domain specific expertise available to clients around the world. Address: GVK Biosciences Pvt Ltd # 210, 6-3-1192 Kundanbagh, Begumpet Hyderabad â€“ 500016, India Tel.: +91 40 5551 9990 Fax: +91 40 5562 6885 Website: www.gvkbio.com ]]> <![CDATA[Millipore introduces Millicell culture plates]]> https://biospectrumindia.com/news/95/2452/millipore-introduces-millicell-culture-plates.html https://biospectrumindia.com/news/95/2452/millipore-introduces-millicell-culture-plates.html Fri, 06 Jan 2006 10:44:00 +0530 Millipore introduces Millicell culture plates Millipore introduces Millicell culture plates Millipore has introduced a 24-well plate and new single-well inserts for cell culture assays. These products are optimized to support suspension and adherent cell growth and differentiation. Additionally, the platform design enhances usability in a range of laboratory environments. Both platforms incorporate track-etched thin film membranes for reliable monolayer formation, microscopically transparent membranes for easy cell visualization and fluorescent-compatible plastics and membranes. The 24-well plate is designed for maximum user convenience and includes features that maintain assay integrity. Additionally, the 24-well Millicell cell culture plate has twice the membrane surface area compared with other 24-well plates. This allows researchers to utilize greater cell mass, which more closely models cell behavior. The plates are automation compatible and reduce the risk of monolayer contamination with "footed" membrane plates that remain elevated when disassembled from the feeder tray and raised-well edges for better tape seating. For further details, visit www.millipore.com Absolute specular reflectance accessory from Thermo Thermo Electron Corporation has introduced its new VN Absolute Specular Reflectance accessory for use with its Evolution 300 and Evolution 600 UV-Vis spectrophotometer series. The Absolute Specular Reflectance accessory incorporates the VN optical design, which provides significant advantages over other available specular reflectance methods. The new Thermo VN accessory will have research and QC applications for anti-reflective coatings, multi-layer coatings, multilayer dielectric coatings, thin films and laser mirrors. Thermo's new VN accessory offers significant design advantages over traditional relative and VW specular reflectance accessories. Unlike relative designs, Thermo's VN accessory is highly accurate and does not require the purchasing of expensive calibrated specular standards, such as first-surface aluminum mirrors to obtain absolute measurements. The Thermo accessory is also not dependent on maintaining the quality of the standard surface which can introduce erroneous results. With the VW design accessory, the light bounces off the sample surface two times, requiring a larger sample surface to accommodate two reflections. In addition, because two separate areas of the sample surface are measured, errors may result if the sample is not homogeneous. For further details, visit www.thermo.com/uv-vis Esco introduces Labculture Biohazard Safety Cabinet Esco has launched its Labculture Class II Type A2 Biohazard Safety Cabinet. The design is an optimum combination of safety, performance, serviceability and ergonomic factors. This cabinet is suitable for general microbiological work with agents assigned to biological safety levels I, II or III, and is designed to protect the user from exposure to biologically hazardous aerosols / particulates generated within the work zone, the product / samples / processes inside the cabinet from ambient contamination present in room air, against cross contamination between different samples in the work zone. The Esco Labculture cabinets are equipped with superior ULPA filters, which operate at a typical efficiency of >99.999% at 0.12 microns, which provide ISO Class 3 air cleanliness within the cabinet work zone. These filters provide a higher level of personnel, product and cross contamination protection as compared to conventional HEPA filters (99.99% efficient). Additionally, the cabinet's airflow is self-regulating; the motor / blower system is able to compensate automatically to maintain airflow as the filter is loaded with particulates. A state-of-the-art unit with a microprocessor based control system, the cabinet allows the user to easily access all control and safety functions. For details, contact: escobiotech@vsnl.net Cambrex offers G-protein coupled receptors Cambrex has introduced G-protein coupled receptors (GPCRs). These receptors are a large super-family of cell-surface proteins whose function is to transduce information from extra cellular space to the cell interior by stimulating (or inhibiting) second messenger systems. Included in this family are receptors for neurotransmitters (such as receptors for dopamine, acetyl choline and histamine) as well as receptors for brain and gut peptides (e.g. bradykinin, gallanin, and various neuropeptides). GPCRs are an important super-family comprising some 800 different members. Drugs currently on the market that do interact with GPCRs interact with only about 100 out of the 800 possible GPCRs. GPCRs still represent un-tapped potential for drug discovery. For details, contact: biosales@cambrexindia.com ]]> <![CDATA[Esco Micro opens office in India]]> https://biospectrumindia.com/news/95/2886/esco-micro-opens-office-in-india.html https://biospectrumindia.com/news/95/2886/esco-micro-opens-office-in-india.html Fri, 06 Jan 2006 10:42:00 +0530 Esco Micro opens office in India Esco Micro opens office in India Singapore-based Esco Micro Pte Ltd, a 9000/ ISO14000 certified manufacturer of Laminar Airflow, Biohazard Safety and other HEPA / ULPA filtered cabinets has started operations in India. "India has been identified as one of the key markets for Esco's activities and the local operations in Mumbai shall provide better support for efficient after-sales services and validation services," said Lim, chief executive officer, Esco Micro Pte Ltd. Esco's equipments like Laminar Airflow and Biohazard Safety Cabinets have been independently tested and certified to international standards such as NSF49, EN12469 and AS1807.5. These equipments are designed for optimum laboratory ergonomics with operator comfort and safety in mind. Esco uses ULPA filters for higher efficiency filtration as compared to conventional HEPA filters. The in-house R&D and Quality control department includes microbiological testing facility and KI discus containment testing in accordance with international Standards like NSF49 (American Standard) and EN 12469 (European standard). The Indian office of Esco along with other support activities will carry out a Biosafety Awareness Program throughout the country. These seminars would share the information about the latest international standards and guidelines on biosafety. Bio-Rad signs pact with Caliper Bio-Rad Laboratories and Caliper Life Sciences announced a new collaboration under which the companies will study the feasibility of developing a new microfluidics system platform. The two companies' previous collaboration, initiated in mid-2003, resulted in the successful launch of a new microfluidics-based electrophoresis product, Experion. "We are looking forward to this next collaboration where we will pursue new ideas regarding LabChip microfluidics as the foundation for innovative, new products," said Norman Schwartz, president and CEO, Bio-Rad. Kevin Hrusovsky, Caliper's president and CEO, said, "Bio-Rad is a model partner for our 'Caliper Driven' program, under which we enable life science companies like Bio-Rad to tap into our innovative technologies, expertise and patent portfolio. Their strong reputation and their well-established global distribution very effectively leverage our technology into key markets." Waters strengthens ACQUITY Ultra Performance LCSystem Product Line Waters Corporation has announced the availability of three advanced detectors specifically designed for Waters ACQUITY Ultra Performance LC (UPLC) System. The three detectors are photodiode array (PDA), evaporative light scattering (ELS) and tunable ultraviolet (TUV) models and bring new versatility to the ACQUITY UPLC System for high-resolution analysis of a wide variety of compounds. The Waters ACQUITY UPLC is a liquid chromatography system that brings laboratories new levels of resolution, sensitivity, speed, and productivity. Whether the scientists are working on new drugs, looking for markers of disease, detecting low level contamination of food or drinking water supplies, recent advances in detector technology mean that scientists using the company's ACQUITY UPLC System platform can obtain more information per unit of time in the laboratory. Optimized for Ultra Performance LC, these detectors are designed for low dispersion characteristics, high data acquisition rates, and robust performance. Programming and monitoring is easily controlled from within Waters Empower chromatography software or MassLynx mass spectrometry software. SAS maintains its position in business intelligence SAS continues its position as a leading business intelligence (BI) vendor, according to Gartner, a prominent analyst firm. Based on 2004 new license sales for both regions, Gartner's ranking shows SAS to be the No.1 BI vendor in terms of revenue in Asia Pacific with 17.5 percent share of revenue and No. 2 in EMEA (Europe, Middle East and Africa) with 17.4 percent BI market share. According to Gartner, the top six countries (based on new license revenue) in the Asia Pacific region include Australia, New Zealand, Singapore, South Korea, China and Hong Kong. SAS Enterprise BI Server, a major component of the SAS 9 Enterprise Intelligence Platform, is an integral factor of SAS' growth in the BI space. The SAS 9 platform empowers users at all levels of an organization by giving them targeted interfaces to support their individual needs and skills. SAS Enterprise BI Server provides a suite of BI functions including reporting, query and analysis, OLAP, integrated analytics, visualization, and integration with Microsoft Office environments. BD Diagnostics, TimeMed collaborate on First Notched Overlabel BD Diagnostics-Preanalytical Systems, a unit of BD (Becton, Dickinson and Company), and TimeMed Labeling Systems announced collaboration intended to help minimize misaligned labeling errors associated with blood specimen collection and analysis, thus improving laboratory efficiency. A recently restyled BD Vacutainer Plus Plastic Tube label includes patented visual guide technology for proper placement of secondary labeling. When used in conjunction with the v-notch label manufactured by TimeMed, positioning of secondary labels becomes much easier and helps reduce errors. "The proper placement of barcoded secondary labeling is extremely important. Misaligned labels may create problems with sample visibility, identification of tube type in the event of removed closure, ability to identify the fill indicator, or inconsistent bar code locations," said Ana Stankovic, worldwide medical affairs director, BD Diagnostics â€“ Preanalytical Systems. ]]> <![CDATA[Agilent launches Advanced Paperless System in India]]> https://biospectrumindia.com/news/95/2569/agilent-launches-advanced-paperless-system-in-india.html https://biospectrumindia.com/news/95/2569/agilent-launches-advanced-paperless-system-in-india.html Fri, 06 Jan 2006 10:41:00 +0530 Agilent launches Advanced Paperless System in India Agilent launches Advanced Paperless System in India Agilent Technologies has introduced its updated compliance portfolio to the Indian market to help pharmaceutical and medical research companies meet global laboratory compliance regulations. Agilent's Compliance Enterprise Edition, an advanced paperless qualification service that can be used across a variety of major vendors' laboratory systems and instrumentation, will help Indian pharmaceutical companies comply with regulations and guidelines such as GMP, GCP, FDA 21 CFR Part 11 and GAMP4. "This is a major coup for Indian labs that have laboratory equipment from a range of vendors, including Agilent, that needs to undergo compliance testing according to international standards," said Sanjeev Dhar, India country manager, Agilent Life Sciences and Chemical Analysis. "Agilent's Compliance Enterprise Edition will streamline and simplify compliance processes, accelerating entry into global markets. Agilent's portfolio of compliance services includes Classic Edition and Software Edition qualification products for all-Agilent labs, Network Edition for network validation projects, and now Compliance Enterprise Edition. Currently, India follows the Organisation for Economic Cooperation and Development (OECD) principles for the (voluntary) Good Laboratory Practices (GLP) certification issued by its National GLP Compliance Monitoring Authority. India's Drugs Technical Advisory Board (DTAB) recently endorsed the view of the Drugs Consultative Committee (DCC) to make GLP mandatory for all drug laboratories in the country. Accelrys launches NanoBiology initiative Accelrys has launched its NanoBiology Initiative to accelerate the development of computational modeling and informatics software that will enable scientists and engineers to apply nanotechnology to key areas of biological research including diagnostics, biosensing, drug delivery and biomaterial design. The Initiative aims to enhance nanobiology R&D, extending the use of nanotechnology into new areas of research. It will bring together experts from industry, government and academia who will work towards the common goal of identifying and prioritizing critical business and technical issues in the area of nanobiology such as design and safety concerns. Dr Leroy Hood, president and co-founder of the Institute for Systems Biology and a leading proponent of biological applications of nanotechnology, will chair the Initiative's Scientific Advisory Committee. Accelrys' core strengths in life science modeling, materials modeling, informatics and workflow technology will be used to develop a comprehensive infrastructure of nanobiology software solutions. These solutions will enable researchers to design novel nanoscale delivery platforms for drugs and diagnostics, nanoscale devices for biosensing and detection, and products for targeted medicine, systems biology and biodefense. Special emphasis will be placed on the smart design of nanosystems and architectures as well as on safety and toxicology issues. The development of customizable, easy-to-use workflows that help researchers streamline their work in nanobiology will also be an objective of the Initiative. Labvantage's Sapphire Biobanking solution supports diabetes research LabVantage Solutions, a provider of enterprise solutions tailored for laboratories, serves discovery, development, formulation, process research, raw material testing, and quality management laboratories across multiple industries, has announced that Amylin Pharmaceuticals, a biopharmaceutical company based in San Diego, CA, has licensed its Sapphire BioBanking Solution. Amylin selected Sapphire for its robust functionality, leading edge technology, and vast flexibility. Sapphire will enhance Amylin's ability to track the increasing number of samples used in research and development of treatments for diabetes, obesity, and cardiovascular disease. The Sapphire BioBanking Solution is designed to address the unique challenges of specimen collection and banking for pharmaceutical discovery and clinical operations, academic and biosciences research centers, medical institutions, and contract research organizations. The solution provides intricate chain-of-custody functionality, detailed location and shipment management, aliquot/derivative and pooled sample tracking, and electronic signature capture upon transfer and disposition. It offers a browser-based user interface and built-it Evergreen configuration tool to tailor the same solution to the needs of each laboratory within the organization. This flexibility also allows it to readily adapt to a variety of data capture, result management, storage and specimen handling circumstances. The solution is seamlessly integrated with Sapphire's existing laboratory information management solution for life sciences R&D to manage experiments and track vital genomic, proteomics, phenotypic and other result information about samples. Furthermore, it can easily be integrated with third party public databases, instruments, clinical trial management systems, electronic data capture systems, and existing laboratory information management systems. TNT Express to use RFID on a global scale TNT Express, announced the second phase of its Radio Frequency Identification (RFID) program, becoming the only integrator to use RFID to track shipments on a global scale. Following the successful trials of phase one and with ongoing system upgrades, the RFID equipment is now ready to fully integrate with TNT's existing systems. RFID readers are able to supply more tracking information than barcode scanners and since they can operate remotely and without human intervention, they allow greater control over shipments. Furthermore, readers are positioned at crucial points in TNT's transit locations to monitor movements, thus enabling tighter security and process control. For the second phase of the program, TNT has formed a partnership with one of the world's largest manufacturers of medical diagnostic products and will design and deliver an RFID solution to monitor the temperature integrity of life-critical chemical re-agents. They will be transported from the TNT-managed regional distribution center in Singapore, to two strategic distribution points in Bangkok and Shanghai, using TNT's newly launched Asia Road Network. Onno Boots, director, global account management, TNT Express, said, "TNT has had to respond to the changing requirements in the life science and high tech markets. Combined with the increase in supply chain complexity, this creates the demand for a system which offers more accurate and reliable tracking of shipments. By adopting more sophisticated RFID technology, TNT has been able to satisfy this demand and further enhance its position as an innovative leader in these markets." Stratagene, Strand to develop next generation bioinformatics tools Stratagene Corporation, a developer, manufacturer and marketer of specialized life science research and diagnostic products, and Strand Life Sciences, have entered into a strategic partnership to develop a suite of next generation bioinformatics software tools. Under the terms of the agreement, Strand and Stratagene will collaborate on the design and development of innovative software tools to address the increasingly complex demands of biological data analysis for life scientists. Stratagene will exclusively market and sell the jointly developed products, which will utilize Strand's award-winning AVADIS technology. "We are very excited about integrating Strand's AVADIS platform into our software solutions product line. This relationship with Strand strengthens our commitment to delivering powerful and easy-to-use bioinformatics tools to the life sciences community," said Joseph Sorge, president and CEO, Stratagene. Stratagene and Strand expect to shortly release two sophisticated yet extremely intuitive software packages that address the two fastest growing bioinformatics software markets today - systems biology - focused pathway analysis and analysis of the new generation of Affymetrix GeneChip Arrays. "We believe that this partnership for informatics solutions will enable Strand and Stratagene to take a strong position in the functional genomics informatics vertical as the leading provider of comprehensive solutions to the research biologist," said Vijay Chandru, chairman and CEO, Strand Life Sciences. ]]> <![CDATA["India is a strategic pillar for the Sartorius Group,"]]> https://biospectrumindia.com/news/95/1723/india-is-a-strategic-pillar-for-the-sartorius-group.html https://biospectrumindia.com/news/95/1723/india-is-a-strategic-pillar-for-the-sartorius-group.html Fri, 06 Jan 2006 10:38:00 +0530 New Page 1 "India is a strategic pillar for the Sartorius Group," Dr Joachim Kreuzburg, Group CEO, Sartorius Group In December 2005, Sartorius, a leading laboratory and process technology provider, announced the restructuring of its business in India by initiating the integration of its Biotechnology and Mechatronics divisions. Dr Joachim Kreuzburg, Group CEO, Sartorius Group, was in India to announce this and other plans. Why have you integrated your Biotechnology and Mechatronics businesses in India? Globally, we are a recognized supplier and R&D partner for the global pharma, biotech, chemical, and food and beverage industries. We do more than 75 percent our business as one of the global Top 3 players in the respective markets. We are operating two divisions-Biotechnology and Mechatronics. While the Biotechnology division covers the entire biotech process chain with filter technology, bioreactors, and services, the Mechatronics division delivers weighing solutions like balances and scales for laboratory and industrial applications. For Sartorius, India is one of the three fastest growing markets worldwide. Further, Sartorius India is one of the three organizations in the Sartorius Group that has R&D, engineering, production and sales and marketing in both the divisions (the other centers being in Germany and the US). The two divisions in India operate as separate companies and we are now combining the management of both under one leadership. Amit Chatterjee will lead the India team as managing director, Sartorius India. We have an ambitious growth plan laid out for India and a key element of our strategy is to present our customers with an integrated range of products and services that meet their functional, regulatory and management needs. This integration will strengthen the competence of process engineering in biotechnology and Mechatronics and offer customers a single window service from laboratory to process scale in weighing, filtration, fermentation and downstream solutions including training and validation services. Why are you so bullish about India? India is a stable and mature market and has a good track record. I am convinced that India will produce the next Amgen or Genentech of the world. It is one of the most dynamic markets and is bestowed with quality people and services. So Sartorius India is a strategic pillar for the Sartorius Group and a major cornerstone of our globalization strategy. For Sartorius, India will be strategic as a hub for engineering and services, as supply center to global markets, and as a domestic market. What are you future plans for India? With the integration, we will be able to enhance our presence, product portfolio and customer interaction. We intend to breach the Rs 100 crore mark in 2006. We had decided to invest an additional sum of $4 million to consolidate, add new facilities and grow. We wish to develop our R&D center here as the global outsourcing base in engineering, components and software development. We have decided on setting up a state-of-the-art process, application, and validation laboratory for the pharma and biotech industries, complete with utilities to support fermentation, down stream processing, sterile filtration and process weighing applications. We will have trained manpower and offer certified training for our customers to fulfil their GMP/GLP needs. This would be up shortly. We are operating from five locations in Bangalore and will consolidate into one facility and expand so that we have enough space to grow this space to support our expansion for the next 10 years. We shall take the decision on the space in the next three months. Our Indian facility is the first center in our group to have received the ASME certification. This means that we can provide high quality vessels for fermentors globally. What are your manufacturing plans? We are currently manufacturing engineering components, cross flow equipment, filtration housing, fermentation products etc. in the biotech arena. In fact on December 5, 2005, Mechatronics' 1,000th production of one line of product was opened. In fact a third of this product has been sold in the Asia-Pacific. We will soon start the production of scales for special markets. We are for example the leading player in the Carat market. We will be investing in industrial weighing solutions. To summarize, we shall be building additional production capabilities in manufacturing. Ch. Srinivas Rao ]]> <![CDATA[BioSpectrum Awards Nite 2005]]> https://biospectrumindia.com/news/95/1636/biospectrum-awards-nite-2005.html https://biospectrumindia.com/news/95/1636/biospectrum-awards-nite-2005.html Fri, 06 Jan 2006 10:35:00 +0530 BioSpectrum Awards Nite 2005 BioSpectrum Awards Nite 2005 Dr Bhan, secretary, Department of Biotechnology, receiving the Person of the Year Award from Dr Cyrus S Poonwalla, chairman, Serum Institute of India. Dr NK Ganguly, DG, ICMR, being honored with the Life Time Achievement Award by Kiran Mazumdar-Shaw, CMD, Biocon Ltd. Sudhir Pai J, MD and CEO, Lotus Labs, receiving the Entrepreneur of the Year Award from Prof. Ajit Varma of Amity Institute of Biotechnology. Dr KK Narayanan, MD, Metahelix, presenting the Product of the Year Award (Q-Vac) to Mr Adar Poonawalla, Member of Board of Governing Council, Trustee, Serum Institute of India Research Foundation. Dr KK Narayanan giving away the Product of the Year Award (Shantetra) to Akshay R Anagal of Shantha Biotechnics. The third BioSpectrum Awards were presented on December 19, 2005. A report on the awards nite. T he third BioSpectrum Awards Nite 2005 was host- ed at Le Meridien, Bangalore on December 19, 2005 to present the awards in recognition of the valuable contributions made to the biotech industry by individuals, products, and companies. Shyam Malhotra, Editor-in-Chief, BioSpectrum, kicked off the function, which saw a gathering of over 275 key officials from the industry, government and academic institutions, enumerating about the Awards and the company's future plans. "The large diverse gathering that we have here today is testimony to the fact of the growing popularity of these acknowledgments of the industry captains," he said. "The biotech industry has crossed the $1 billion mark in 2004-05. Further, an industry-friendly biotech policy was in the final stages of getting approval, thanks to the proactive steps taken by Dr MK Bhan." Malhotra pointed out that BioSpectrum was CyberMedia's first foray into a non-IT area. "CyberMedia is a 23 year-old company, which is mostly into IT publishing and other IT-related activities. We had an IPO in 2005 and did very well. We were probably amongst the top five in the 50 odd IPOs that have happened in the last six-eight months." He informed the audience that CyberMedia would shortly launch BioSpectrum Asia. "It is an integrated media plan and we will have a BioSpectrum Asia print magazine, an electronic magazine, and a dedicated online edition. They are all slated to be launched in January-February 2006 and with that we hope to increase the footprint of this industry across the entire region and not just limit to India. We are also drawing up other expansion plans for next year. We are confident that these will continue the growing benefits for both our customers, the readers as well as the advertisers as we go forward," said Malhotra. Panel Discussion On the occasion, BioSpectrum organized a short panel discussion on the theme "Biotech Industry's Wish List to the Finance Minister for Union Budget 2006." The discussion was moderated by Sarath Naru, managing director, APIDC-VC Ltd, Hyderabad and Narayanan Suresh, Editor, BioSpectrum. The panelists included Kiran Mazumdar-Shaw, CMD, Biocon, Bangalore, Dr K VijayRaghavan, director, NCBS, Bangalore, Deepanwita Chattopadhyay, CEO, ICICI Knowledge Park, Hyderabad, Prof. AS Kolaskar, vice-chancellor, University of Pune, Pune, Dr KK Narayanan, CMD, Metahelix, Bangalore, Dr Shama Bhat, CMD, Bhat Biotech, Bangalore, Dr Mittur N Jagadish, director, Monsanto Research Centre, Bangalore, and Dr SD Ravetkar, senior director, Serum Institute of India, Pune. BioSpectrum Awards 2005 Selection Dr Cyrus S Poonawalla, chairman, Serum Institute of India, who chaired the jury which selected the awardees, briefly explained about the award selection process. "The process that we followed was totally transparent. The selection was totally in passion. Most of the panel members were peers in the industry except for having the vice-chancellor of the Pune University who was an independent person and that added to the color of the selection," Poonawalla said. "Prof. Kolaskar was a great help for an independent evaluation when there was a close call on one or two selections. The process was that the biodata with a write-up on each recommended candidate was circulated among the jury members and each member had a chance to comment on them and in many cases, I had to take a consensus. For example, except one or two selections, most of them were not unanimous which is healthy. Chairing the jury was a great learning experience for me and I hope these awards grow in the future," he added. BioSpectrum-ABLE Industry Awards The first set of Awards to be presented were the top company awards on the basis of the BioSpectrum-ABLE Industry Survey held in May-June 2005. Biocon Ltd walked away with three awards in different categories. Biocon Ltd was presented the BioPharma Company of the Year Award for being the top biopharmaceuticals company in the country for FY 2005 with sales revenue of Rs 556.67 crore. It also bagged the BioIndustrial Company of the Year Award for continuing to have a stronghold on its oldest business of enzymes. Biocon Ltd is one of the largest manufacturers of enzymes, with total sales from this business alone standing at Rs 89.68 crore in 2004-05, registering 34.82 percent growth. Syngene International, a subsidiary company of Biocon, was presented the BioServices Company of the Year Award. Syngene topped the BioSevices sector, clocking Rs 66.06 crore from the contract research business in 2004-05, recording 72 percent growth. MAHYCO-Monsanto Biotech (India) Ltd was awarded the BioAgri Company 2005 Award for aggressively pushing for the success of Bt-cotton-the first transgenic crop in India and being the leader in the agribiotech sector with revenues of Rs 166.40 crore. It sold 13 lakh packets of Bollgard cotton in 2004-05 compared to 2.16 lakh packets in 2003-04. Labindia Instruments won the BioSupplier Company of the Year Award. It was the largest biotech supplier of FY 2005. Its total life sciences business was Rs 119 crore. Labindia is a leading supplier of various products to the life sciences industry. Jawaharlal Nehru University was rated the best biotech school in the country in India's 2nd Top 20 Biotech Schools survey conducted by BioSpectrum in November 2005 with a score of 49.69. It ranked very high on infrastructure and industry-interaction scores. The award will be given away during the BioSpectrum Student Lecture Series event in January 2006. BioSpectrum Awards 2005 The main category of Awards was the next to follow. These Awards were selected by the jury headed by Dr Poonawalla, which comprised Prof. AS Kolaskar, vice-chancellor, University of Pune, Pune; Dr KK Narayanan, managing director, Metahelix, Bangalore; Deepanwita Chattopadhyay, CEO, ICICI Knowledge Park, Hyderabad; Sarath Naru, managing director, APIDC-Venture Capital Ltd, Hyderabad; Shyam Malhotra,Editor-in-Chief, BioSpectrum, and other CyberMedia Publications, Gurgaon; and E Abraham Mathew, Chief Editor, BioSpectrum, Bangalore. Dr Aravinda Babu, head, operations, WellQuest, Mumbai could not attend the meeting but sent his selection to the jury members. The Product of the Year Award was given away jointly to the quadravalent vaccines developed by Serum Institute of India and Shantha Biotechnics. While Dr Adar Poonawalla, Member of Board of Governing Council, Trustee, Serum Institute of India Research Foundation, received the award for Serum Institute's Q-Vac, Akshay R Anagal, manager - business development, Shantha Biotechnics, received the award for Shantetra, Shantha Biotechnics' quadravalent vaccine, from Dr KK Narayanan. Sudhir Pai J, managing director and CEO, Lotus Labs was presented the Entrepreneur of the Year Award by Prof. Ajit Verma, director, Amity Institute of Herbal & Microbial Studies. Kiran Mazumdar-Shaw gave away the Life Time Achievement Award to Dr Nirmal Kumar Ganguly, director general, ICMR, while Dr MK Bhan received the Person of the Year Award from Dr Cyrus S Poonawalla. In his short acceptance speech, Dr Ganguly stressed on the need for increased investment in the health sector as many of the biotech products reach a very small section of the population. "The investment in health sector must be increased so that products will be absorbed and used in the population and will go across to the developing countries." Gautam Reddy of Biocon receiving the BioIndustrial Company 2005 Award from a representative of the RK Group of Institutions. VS Upadhye, CEO, Labindia Instruments, receiving the BioSupplier Company 2005 Award from Deepanwita Chattopadhyay, CEO, ICICI Knowledge Park. Dr Mittur N Jagadish, director, Monsanto Research Centre, receiving the BioAgri Company 2005 Award for MAHYCO-Monsanto from Prof. AS Kolaskar, VC, Pune University. Abhijeet Zutshi of Biocon poses after receiving the BioPharma Company 2005 Award from Prof. Elsamma Thomas, prinicipal, The Oxford College of Science. Abraham E Mathew, Chief Editor, BioSpectrum, presenting the BioServices Company 2005 Award to Arun Natarajan of Syngene International. He added, "We need to have much more robust inter-sectorial capabilities so that the decisions made together will ultimately combine to enable the product we make and put it forth to the people." He also felt the need to promote the private sector and private laboratory networks. "Until and unless we do this, there will not be the required growth because private sector is capable of moving much faster than the current public health sector and here more concessions are needed." Dr Bhan in his acceptance speech said that the DBT was grappling with the idea of becoming a continuously evolving organization. "There were some solid steps and good accomplishments and we need to consolidate them but I also believe we must continuously evolve, continuously change and continuously experiment fearlessly on scale with the right kind of investments," he said. Underlining the need for India and the biotech industry to become world class, Dr Bhan said, "Until we think our practices are comparable to the best, we should not cease to make efforts and we should not become complacent too soon." "We got the SBRI going and I'm happy to tell you that although we got the approval only on September 30, within eight weeks time, 60 of the 70 proposals that we received, have been approved today. I hope to give this year at least 25 percent of the DBT's total budget to industry-related research and the industry needs to be sensitive to this." Announcing that 50 centers of excellence will be funded by the DBT, he said one model center would be started and this would be replicated elsewhere. Giving a call to the biotech companies to expand the density of their scientist manpower, he said the DBT had gone ahead with a proposal to ask the government to give a national pool of jobs "so that we can plug them into centers of excellence and generally spread them around in public-private R&D groups." Dr Bhan said, "We intend to go to the Parliament with a Bayh-Dole legislation so that reward for innovation goes to investigators, scientists and universities." Speaking on forging academic linkages with reputed international universities, Dr Bhan said the first deal would be with Stanford University. "We also decided that the DBT in partnership as well as alone should run a grade school to produce highly skilled quality people with a global brand name. By the end of the next year, we should have the first batch in place," he said. On the occasion, Dr Bhan released the second Top 20 Biotech Schools Survey special issue brought out by BioSpectrum. He also released a BioSpectrum desktop calendar for 2006 titled Aspirations. The event was sponsored by State Bank of India, BioAsia 2006, The Oxford College of Science, RK Institute of Management and Computer Sciences and Amity Institute of Biotechnology. Namratha Jagtap ]]> <![CDATA[GSK]]> https://biospectrumindia.com/news/95/2748/gsk.html https://biospectrumindia.com/news/95/2748/gsk.html Fri, 06 Jan 2006 10:33:00 +0530 GSK GSK's Cervarix induces higher immune response in adolescents Cervarix, GlaxoSmithKline's candidate cervical cancer vaccine, formulated with the proprietary adjuvant AS04, induced antibody levels against the two most common cancer-causing HPV types (HPV 16/18) at least two-fold higher in 10-14 year-old adolescent girls, than in women 15-25 years old, a new study shows. The candidate vaccine for cervical cancer was also shown to induce antibodies in 100 per cent of volunteers in both age groups one month after completion of the course of vaccination. The vaccine in the present study was well tolerated and adverse event rates were similar in each age group. No vaccine-related serious adverse events were reported. Recent positive findings have demonstrated that the AS04 adjuvant in the candidate vaccine induces a stronger, sustained immune response when compared to a formulation with aluminum salt alone in young adult women. In the study presented recently, the higher antibody levels observed in the pre-teen/adolescent group â€“ compared to that observed in women 15-25 years old â€“ are important as the elevated levels demonstrated in this younger age range may result in longer duration of protection. It would be beneficial to vaccinate adolescents against infection with cancer-causing HPV types 16/18 well before the start of sexual activity with a vaccine with sustained efficacy. While GSK's goal is to provide a cervical cancer vaccine for women over a broad age range, the study was designed specifically to compare the immunogenicity and safety of the candidate vaccine in the younger 10-14 year-old group with the 15-25 year-old group. The results were presented at the Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC), in Washington DC, USA. "Vaccination of pre-teen/adolescent girls against cancer-causing HPV before onset of sexual activity will be an important part of the overall strategy for cervical cancer prevention," said Anna-Barbara Moscicki, Professor of Pediatrics, University of California, San Francisco. "Prevention of high-risk HPV 16 and HPV 18 infection is key to reducing cervical cancer, and a prophylactic vaccine against these types of HPV is necessary to prevent infection in the first place. The higher levels of antibody titers seen in the vaccinated preteens/teens than the vaccinated adults offers encouraging evidence that in this age group, a stronger immune response could translate into longer protection. Ongoing studies should further demonstrate these findings." HPV is the leading cause of cervical cancer. Although there are many oncogenic types of HPV, globally, approximately 70 per cent of all cervical cancer cases are associated with just these two cancer-causing types, HPV 16 and HPV 18. GlaxoSmithKline's cervical cancer vaccine candidate targeting HPV 16/18 is currently undergoing Phase III clinical trials involving more than 30,000 women worldwide. This was a Phase III, randomized, double-blinded trial conducted in multiple centers in Denmark, Estonia, Finland, Greece, the Netherlands and the Russian Federation. Cervical cancer is a major global health problem, with nearly 500,000 new cases occurring each year worldwide. It is the second most common cancer â€“ and the third leading cause of cancer deaths â€“ in women worldwide. Each year an estimated 270,000 women die from the disease, and it is the leading cancer killer of women in the developing world. Sneaking drugs into the brain may be possible Clive Svendsen, professor of anatomy and director, Stem Cell Research Program. One of the great challenges for treating Parkinson's Disease and other neurodegenerative disorders is getting medicine to the right place in the brain. The brain is a complex organ with many different types of cells and structures, and it is fortified with a protective barrier erected by blood vessels and glial cells - the brain's structural building blocks - that effectively block the delivery of most drugs from the bloodstream. Scientists have now found a novel way to sneak drugs past the blood-brain barrier by engineering and implanting progenitor brain cells derived from stem cells to produce and deliver a critical growth factor that has already shown clinical promise for treating Parkinson's Disease. Clive Svendsen, a neuroscientist at the University of Wisconsin-Madison and his colleagues have demonstrated that engineered human brain progenitor cells, transplanted into the brains of rats and monkeys, can effectively integrate into the brain and deliver medicine where it is needed. The Wisconsin team obtained and grew large numbers of progenitor cells from human fetal brain tissue. They then engineered the cells to produce a growth factor known as glial cell line-derived neurotrophic factor (GDNF). In some small but promising clinical trials, GDNF showed a marked ability to provide relief from the debilitating symptoms of Parkinson's. But the drug, which is expensive and hard to obtain, had to be pumped directly into the brains of Parkinson's patients for it to work, as it is unable to cross the blood-brain barrier. In an effort to develop a less invasive strategy to effectively deliver the drug to the brain, Svendsen's team implanted the GDNF secreting cells into the brains of rats and elderly primates. The cells migrated within critical areas of the brain and produced the growth factor in quantities sufficient for improving the survival and function of the defective cells at the root of Parkinson's. In the new Wisconsin study, the GDNF-producing cells transplanted in the striatum, a large cluster of cells in the brain that controls movement, balance and walking, of animals with a condition like Parkinson's showed that not only a critical drug could be delivered to the right place but also the drug was delivered in a way that promoted its therapeutic potential. The researchers reported new nerve fiber growth in the striatum and the transport of the critical nerve growth factor GDNF from the striatum to the substantia niagra, the part of the brain that harbors the cells that produce dopamine. The transplanted cells survived and continued to produce GDNF in laboratory animals for up to three months. One hurdle that needs to be overcome before such a technique could be attempted in human patients, said Svendsen, is developing a method to switch transplanted cells on or off and thus control their drug delivery capabilities. Working with engineered cells in culture, the Wisconsin group found they could switch the cells on and off using a second drug. The new study, Svendsen argued, proves that progenitor cells - cells that can now be made in large quantities in the laboratory - can be crafted to help clinicians deliver drugs where they are needed most in the body. Delivering medicine to the brain, whose blood-brain barrier effectively excludes more than 70 percent of all drugs, would be an especially valuable use for the cells. Such a new method may be useful for treating a number of neurodegenerative diseases beyond Parkinson's, he added. Tiny self-assembling cubes could carry medicine, cell therapy (A) Optical image showing a collection of biocontainers. (B-D) Optical and Scanning electron microscopy images at different stages of the fabrication process: (B) the 2D precursor with electrodeposited surfaces, (C) the precursor with surfaces and hinges, and (D) the self-assembled biocontainer. Johns Hopkins researchers have devised a self-assembling cubeshaped perforated container, no larger than a dust speck that could serve as a delivery system for medications and cell therapy. The relatively inexpensive microcontainers can be mass-produced through a process that mixes electronic chip-making techniques with basic chemistry. Because of their metallic nature, the cubic container's location in the body could easily be tracked by magnetic resonance imaging. The method of making these self-assembling containers and the results of successful lab tests involving the cubes were reported in a paper published in the December 2005 issue of the journal Biomedical Microdevices. In the tests, the hollow cubes housed and then dispensed microbeads and live cells commonly used in medical treatment. David H Gracias, who led the team is an assistant professor in the Department of Biomolecular and Chemical Engineering in the Whiting School of Engineering at Johns Hopkins. He focuses on building micro and nanosystems with medical applications. He believes the microcontainers developed in his lab could someday incorporate electronic components that would allow the cubes to act as biosensors within the body or to release medication on demand in response to a remote-controlled radio frequency signal. Gracias is of the view that this is an entirely new encapsulation and delivery device that could lead to a new generation of 'smart pills.' The long-term goal is to be able to implant a collection of these therapeutic containers directly at the site or an injury or an illness. To make the self-assembling containers, Gracias and his colleagues begin with some of the same techniques used to make microelectronic circuits: thin film deposition, photolithography and electrodeposition. These methods produce a flat pattern of six squares, in a shape resembling a cross. Each square, made of copper or nickel, has small openings etched into it, so that it eventually will allow medicine or therapeutic cells to pass through. The researchers use metallic solder to form hinges along the edges between adjoining squares. When the flat shapes are heated briefly in a lab solution, the metallic hinges melt. High surface tension in the liquified solder pulls each pair of adjoining squares together like a swinging door. When the process is completed, they form a perforated cube. When the solution is cooled, the solder hardens again, and the containers remain in their box-like shape. The tiny cubes are coated with a very thin layer of gold, so that they are unlikely to pose toxicity problems within the body. The microcontainers have not yet been implanted in humans or animals, but the researchers have conducted lab tests to demonstrate how they might work in medical applications. Gracias and his colleagues used micropipettes to insert into the cubes a suspension containing microbeads that are commonly used in cell therapy. The lab team showed that these beads could be released from the cubes through agitation. The researchers also inserted human cells, similar to the type used in medical therapy, into the cubes. A positive stain test showed that these cells remained alive in the microcontainers and could easily be released. At the Johns Hopkins School of Medicine's In Vivo Cellular and Molecular Imaging Center, researcher Barjor Gimi and colleagues then used MRI technology to locate and track the metallic cubes as they moved through a sealed microscopic s-shaped fluid channel. This demonstrated that physicians will be able to use non-invasive technology to see where the therapeutic containers go within the body. Some of the cubes (those made mostly of nickel) are magnetic, and the researchers believe it should be possible to guide them directly to the site of an illness or injury. The researchers are now refining the microdevices so that they have nanoporous surfaces. Gimi, whose research focuses on magnetic resonance microimaging of cell function, envisions the use of nanoporous devices for cell encapsulation in hormonal therapy. He also envisions biosensors mounted on these devices for non-invasive signal detection. ]]> <![CDATA[Oral treatment for Psoriasis soon]]> https://biospectrumindia.com/news/95/5859/oral-treatment-for-psoriasis-soon.html https://biospectrumindia.com/news/95/5859/oral-treatment-for-psoriasis-soon.html Fri, 06 Jan 2006 10:31:00 +0530 Oral treatment for Psoriasis soon Oral treatment for Psoriasis soon There is no present cure for psoriasis, but there are a number of drugs and treatments that can relieve and control psoriasis, often for long periods of time. Help will soon be at hand for people suf fering from psoriasis. Lupin Labo- ratories has received the approval from the Drug Controller General of India (DCGI) for conducting Phase II clinical trials of its investigation new drug candidate LLL-3348 (Desoris). Desoris is a proposed treatment of moderate to severe chronic stable plaque-type psoriasis. The approval has come on the company's successful completion of the therapeutic evaluation and safety profiling of Desoris in Phase I single and multiple dose study in healthy volunteers. The formulation being an orally bioavailable and safe drug, will now be evaluated for efficacy in patients in a Phase II clinical trial by the company spanning 10 sites across India, starting very shortly. Speaking about the clearance for further clinical trials, Dr DB Gupta, chairman, Lupin, said that they are very excited that the regulatory authorities found out data promising enough to give permission for further trials. Psoriasis is one of the most common dermatological diseases affecting around 2 percent of the world population. It is a chronic inflammatory skin disorder with most common areas affected being the joints like elbows, knees, gluteal cleft and scalp. Its cause and pathogenesis are not clearly understood. This disorder is recognized for its peculiar clinical symptoms characterized by circumscribed red patches covered with white scales resulting in itchy flaky skin. It ranges from a few spots to large areas all over body. Although psoriasis manifests as a skin disorder, it is believed to be a disease of impaired or defective cell mediated immunity. Most importantly, no preventive/curative therapy exists for psoriasis except the symptomatic management. Hence there has been an impending need for effective and safe oral drugs in the global pharmaceutical market for this disease. Psoriasis does not affect the overall general health. If it is widespread, it can cause skin discomfort and emotional embarrassment, and can affect job and leisure time activities Based on the traditional knowledge, this project involving the development of a single plant based oral herbal formulation was initiated under the Council of Scientific and Industrial Research's (CSIR) New Millennium Indian Technology Leadership Initiative (NMITLI). NMITLI is a unique Indian public-private partnership to secure a leadership position for the country in niche areas based on technology through "Team India" effort. Adopting the reverse pharmacology approach, the project is being led by Lupin Laboratories as the industry partner. The project network involves two institutional partners. The drug candidate is an herbal aqueous extract of a single plant that has a novel mechanism of action and effectively modulates the cellular function leading to marked psoriatic lesion improvement without any toxic effects. Lupin has developed this product in the form of capsules. Extensive studies comprising fingerprinting, activity guided fractionation, efficacy studies, toxicology, safety pharmacology, pharmacokinetics and toxicokinetics had earlier helped the company in filing an Investigational New Drug (IND) application in December 2003, which was cleared in March 2004. Lupin then commenced the Phase I clinical trial for Desoris in September 2004 and successfully completed it. Based on animal data, the drug has been found to be efficacious and safe and animal pharmacokinetic data suggests that the botanical Desoris could be used once a day. The candidate has been developed conforming to the guidelines laid down by the US FDA for botanicals as well as DCGI norms on new drug development. The estimated market for psoriasis therapeutics is around $4 billion and the development will enable India to capture a significant part of the market. Rolly Dureha Effective, safe anthrax vaccine can be grown in plants Henry Daniell, professor at the Burnett College of Biomedical Sciences, conducted his research on the anthrax vaccine with help from scientists at the NIH. Enough anthrax vaccine to inoculate everyone in the US could be grown inexpensively and safely with only one acre of tobacco plants, a University of Central Florida molecular biologist has found. Mice immunized with a vaccine produced in UCF professor Henry Daniell's laboratory through the genetic engineering of tobacco plants survived lethal doses of anthrax administered later by National Institutes of Health researchers. The results of the NIH-funded study are featured in the December issue of the Infection and Immunity journal. Daniell's research is a breakthrough in efforts to find a safe and effective method of producing large quantities of vaccine for anthrax, one of the top bioterrorism threats facing the US. The new production method also could help the government and health care providers avoid supply shortages, as one acre of plants can produce 360 million doses in a year. Current production of the vaccine involves an expensive fermentation process that can cause harmful side effects such as inflammation, flu-like symptoms and rashes. This has prompted some people to refuse to be vaccinated. Seeking a safer and more effective alternative, Daniell and his colleagues injected the vaccine gene into the chloroplast genome of tobacco cells, partly because those plants grow much faster than carrots, tomatoes and coffee. They grew the cells for several weeks in Daniell's laboratory. Tests showed the vaccine taken from the plants was just as potent as the one produced through fermentation but lacks the bacterial toxin that can cause harmful side effects. Researchers then injected the vaccine into mice to immunize them against anthrax and sent the mice to NIH labs, where they survived doses of anthrax several times stronger than the amounts to which humans have been exposed. The next step for the anthrax vaccine would involve a company working with NIH to conduct clinical trials. Human subjects would be injected only with the vaccine and not with anthrax itself, and scientists would then check the subjects' immunity levels. The vaccine later could be mass-produced and stockpiled for emergencies. Daniell's work holds promise for treating other diseases, including diabetes and hepatitis, and improving vaccines for plague, cholera and other bioterrorism agents. He is developing a new technology that would enable vaccines to be administered orally and allow effective and less expensive treatments to be more accessible worldwide. He also believes fruits and vegetables such as carrots and tomatoes are the keys to figuring out a way for people to take anthrax vaccines orally in capsules of dried plant cells that contain correct doses of the protective antigen. ]]> <![CDATA[ABLE'S Recommendations For Budget 2006]]> https://biospectrumindia.com/news/95/2365/ables-recommendations-for-budget-2006.html https://biospectrumindia.com/news/95/2365/ables-recommendations-for-budget-2006.html Fri, 06 Jan 2006 10:27:00 +0530 ABLE ABLE'S Recommendations For Budget 2006 Pre-VC financing for biotech products: There exists a critical funding gap between "Concept to Proof-of-Concept" after which VCs can take over. It is therefore recommended that Budget 2006 provides for the following initiatives: Equipment Used in Biotech Production Animal cell culture fermenter Automatic closing machine Automatic filling machine Automatic labeling machine Automatic vial washing machine Chromatography columns Dehydrogenation oven Explosion proof refrigerated centrifuge Fermenter system including controls and automation High Pressure homogenizer High Pressure Liquid Chromatography System High Speed Centrifuges Homogenizer (Low pressure) Instrumentation like pH probe, DO2 probe, Mass Flow meter, Methanol sensor, pressure transmitters, temperature transmitters, etc. Isolators Lot printing machine Low Pressure Chromatography System Lyophillizer / Freeze Drier Mobile laminar flow cabinet Refrigerated Centrifuges Reverse Phase High Pressure Liquid Chromatography System Revision tables Sterile Cartridge filters Tangential Flow Filtration System (including Microfiltration, Ultrafiltration, Diafiltration) Tubular Centrifuge   A Rs 50 crore fund as Innovation Development Fund to enable research scientists at academic laboratories to develop scientific innovations from a concept to a form that is licensable. This fund should be under the administration of the Department of Biotechnology (DBT) and the grants may be capped at Rs 50 lakh per project. A Rs 200 crore Product Development Fund or Seed Capital Fund under DBT to enable Small and Medium Enterprises (SMEs) to develop in-licensed or in-house innovations to a "Proof of Concept" stage to qualify for VC funding. Such funds may be disbursed as 10-year soft loans with a two-year moratorium on capital repayment and a low interest rate of 3-5 percent. The loans may be capped at Rs 2 crore per project. Duty exemption norms to include components: There exists a serious anomaly with respect to imported and indigenous diagnostics and life saving drugs wherein raw materials and components used by indigenous manufacturers for such products are levied customs import duty and excise duty whereas the finished products are allowed to be imported duty free. It is therefore recommended that components and raw materials used by indigenous manufacturers for the production of diagnostics and life saving drugs are exempt from Excise and Custom Duty. Excise Duty waiver for diagnostic kits: Indigenous diagnostic kits are levied 16 percent Excise Duty whereas imported kits are exempt from all duties. Diagnostic kits are vital for HIV/AIDS, infectious diseases and other critical care applications. The positive impact of such an Excise Duty waiver will far exceed the small impact it will have on the exchequer. Exemption on customs import duty on R&D equipment: If India is to realize the full potential of its scientific skill base at a commercial level, it is imperative to adopt all measures that reduce the capital cost of R&D. Currently, R&D equipment as specified in List 27A and List 28 of the Custom Notification No: 26/2003 dated 01.03.2003 by DSIR recognized Research Laboratories are exempt from Customs Duty. These equipment are essential to biotech and pharmaceutical research. Duty drawback for R&D consumables: Likewise, the import of R&D consumables are subject to the full incidence of Import Duties at nearly 33 percent as no Countervailing duty credit is available on R&D consumables. It is therefore recommended that import of R&D consumables be made eligible for Duty Drawback based on DSIR certification. Weighted average tax deduction on R&D expenditure: The current provision for a 150 percent weighted Tax deduction u/s 35 (2AB) for R&D expenditure incurred by DSIR recognized Research Laboratories has been a great boon to incremental R&D investment. With the new challenges imposed by the WTO-TRIPS regime, R&D investments will need to be augmented even further. It is therefore recommended that the weighted deduction be increased to 200 percent and the scheme be extended for a further period of three years i.e., up to 2010. Inclusion of international patent filing costs u/s 35 (2AB): There exists a lacuna in the current taxation system wherein expenditure pertaining to Indian patent filings is eligible for weighted tax deduction but international patent filings are disallowed. Now that WTO-TRIPS has taken effect and given the increasing importance of international patents in exports to regulated markets, it is recommended that expenditure pertaining to international patent filings be included u/s 35 (2AB) for weighted tax deduction for R&D. Exemption of withholding tax for technology transfer and licensing: The existing requirement for withholding tax for technology transfer results in increased cost of import of technology. In order for Indian companies to acquire technology, it is recommended that import of technology by the biotech sector be exempt from Withholding Tax for a period up to 2010. Laboratory Air Sampler Anaerobiosis Jar Beta Counter Cell Roll Centrifuge Colony Counter Double Door Class 100 oven Electrophoresis System (DNA and protein) Filter Integrity Test Equipment Fireboy Flow Cytometer FPLC chromatography Gamma Counter Gas Chromatography system Glucose and Lactate Analyzer High precision analytical balances HPLC Chromatography Hybridization Oven Image Analysis System Inverted Optical Microscope Kjeldahl System Low temperature incubators (-20oC and below) Micro-centrifuge (microlitre) Micro-Hematocrit centrifuge with reader Microtomo Phastsystem and Phastimagen Pippette boy Plate Reader Platform Rocker Refractrometer Spectrophotometer TOC Analyzer Tube Rotator Vacuum Concentrator Vascular Shaker Relaxed export obligation norms for biotech parks availing of SEZ status: The changes in Foreign Trade Policy permits biotech companies located in state sponsored biotech parks to avail Duty free import of equipment, instruments and consumables and tax holiday under Section 10A/10B of the Income Tax Act. However, the above benefits are only available to 100 percent Export Oriented Biotech Units and therefore similar to the benefits enjoyed by 100 percent EOUs in all other industrial sectors. It is also recommended that the Export Obligation norms be made applicable after a duration of five years. Minimum requirement for a biotech SEZ: The minimum area required for setting up a Biotech SEZ be restricted to 25 acres of land or 1 million sft of building area, similar to the norms specified for the IT industry. One-year moratorium from price control: Biotech products manufactured in India be given a one-year moratorium from price control under NPPA to provide for sufficient time to scale up production and streamline costs. The present requirement for approval from NPPA prior to launch leads to substantial delay in launch of the product. It is also recommended that R&D expenditure incurred on biotech products be permitted for amortization in computing costs for the purposes of price fixation. Expansion of the list of capital goods under list 27A and 28: The concessions presently provided to biotech companies permitting duty free import of equipment as per List 27A and List 28 of Custom Notification No 26/2003 dated 01.03.2003, by manufacturers having a R&D wing registered with the DSIR, to the extent of 25 percent of the FOB value of exports made in the previous year is not beneficial as List 27A and List 28 covers R&D Equipment and as such they cannot be used for manufacture. Also new companies cannot avail of these benefits, as they would not have any exports in the previous year. It is therefore recommended that the existing schemes be amended to cover the following: Expansion of the List of Equipment provided in List 27A and List 28 to cover equipment required for manufacture of Biotech products as per Annexure. New companies be permitted to import equipment at Nil Duty to the extent of 25 percent of the project cost, as certified by DBT or recognized financial institution. The restriction of 25 percent of FOB value of exports and recognition by DSIR be waived for new companies for a period of five years from date of incorporation. Priority sector lending for biotechnology: Biotech entrepreneurs have great difficulty in obtaining bank financing as this sector has a high-risk profile with long gestational time lines, which are not conducive to lending. Currently, lending to the agri-business sector as well as to venture funds is categorized as Priority Sector Lending. It is therefore recommended that lending to the biotech sector be categorized as priority sector lending. Also it is proposed that Rs 200 crore of funds under the Technology Development Board be earmarked for providing long term funds to biotech companies Budgetary allocation for state supported biotech parks: Though several state governments have taken initiatives to promote biotechnology parks, there is need for an incentive from the central government in form of budgetary allocation to support state governments in furthering the interests of biotechnology through dedicated parks. The parks can also facilitate development of incubation facilities, which would help entrepreneurs or start-ups with limited resources to carry on their innovation-related activities. Budgetary allocation for an IPR arbitration council: With India's commitment to TRIPS agreement under WTO and introduction of Product Patent regime from January 1, 2005, it has become imperative to enforce the same with the same spirit. However given the stress under which Indian judicial system operates and backlog of cases, industry feels that existing system would not be capable to handle the IPR related disputes efficiently. Additionally, the judges may not be fully versed with the technical details of IPR related issues and there is need to have specially trained judicial personnel and courts to showcase India as next hub for contract research, clinical trials and contract manufacturing in biotechnology space. Budgetary allocation for a world-class accreditation agency: India can leapfrog in biotech with quality manufacturing and services. This requires setting up of an internationally accepted accreditation agency, which can set standards, protocols and act as gatekeeper for producing world-quality products and services. The agency can also liaison with internationally bodies of repute such as USFDA, BP and TGA for setting up guidelines for its functioning and operations.   ]]> <![CDATA[FICCI's Suggestions]]> https://biospectrumindia.com/news/95/2162/ficcis-suggestions.html https://biospectrumindia.com/news/95/2162/ficcis-suggestions.html Fri, 06 Jan 2006 10:26:00 +0530 FICCI FICCI's Suggestions FICCI proposes that the new Biotech inventions or products manufactured for the first time in India should be given tax exemption for at least two years after the commercial launch of the product. In terms of Section 80-IB (8A), any company carrying on scientific research and development is allowed a deduction of 100 percent of the profits and gains of such business for a period of 10 consecutive assessment years, if such company is for the time being approved by the prescribed authority after March 31, 2000 but before April 1, 2005. With a view to promote scientific research and development in the country, it is proposed to allow the deductions to companies carrying on scientific research and development approved by the prescribed authority till April, 2010 as against March 31, 2007 at present. Expenditure incurred on patents filed in India and abroad by companies should be treated as R&D expenses. Customs duty exemption on capital goods and raw materials be extended to all biotechnology companies engaged in R&D irrespective of the fact whether it is funded by the government or not. Reduction in customs duty should be extended to all the equipment used by the biotechnology sector. Most of the biotech products and formulations are new to our country. So they are not appearing under a specific heading in central excise tariff, but central excise duty is charged at 16.32 percent basing on broad nature of the product being manufactured. Whereas most of the time the same product is being imported in to the country under NIL duty under Customs tariff. This NIL duty may have been incorporated in Customs tariff on account of criticality of the product for human health care and non availability of the same in India earlier. But most of these products are now manufactured in India and the continuity of such NIL duty concession is causing lot of hardship to Indian biotech manufacturers since the imported product has a price advantage due to NIL rate of customs duty. The government mayconsider and equalize the duty structure for imported and locally manufactured biotech product. The Central excise tariff currently provided for exemption of central excise duty on products, which are patented in more than two countries (one in India and other in the US or Europe). But the normally patent granting is a highly time consuming and costly process, and it normally takes 4-5 years to get a patent in the specified countries. So we propose that the rule should be amended to as application of the Patent rather than the actual grant of Patent with a condition that if the Patent is not granted the central excise duty need to paid with retrospective affect. FICCI strongly suggests that biotech industry need to be provided with support of tax holiday for at least for first two to three years after the product commercialization to sustain heavy capital and R&D expenditure made during product development. Some State Governments in India have already waived the sales tax on vaccines and bio-pharma products. Similarly, central sales tax too could be waived off. Another area where government should look into for giving maximum concessions is that of food technology segment. India has enough agriculture outputs but there are not adequate facility to store/process agricultural products or its derivatives. So the waiver of import duties on food storage and processing equipment will improve the economic condition of the former. The R&D segment should be given all the possible incentives like allowing all the inputs and equipment, if not produced in India, free of any taxes and duties. This should include the import of animals for trial purposes. To consider and extend any of these suggestion the government may have to authorize a single administrative authority to grant, as well as monitor the use of incentives and to avoid misuse of the benefits given. ]]> <![CDATA[Dr Mashelkar presented Stars of Asia Award]]> https://biospectrumindia.com/news/95/1628/dr-mashelkar-presented-stars-of-asia-award.html https://biospectrumindia.com/news/95/1628/dr-mashelkar-presented-stars-of-asia-award.html Fri, 06 Jan 2006 10:19:00 +0530 Dr RA Mashelkar Dr RA Mashelkar, Director General, CSIR receiving the Stars of Asia Award from George Bush Sr., former US President. Dr Mashelkar presented Stars of Asia Award Dr RA Mashelkar, Director General, CSIR, was presented the Stars of Asia Award by George Bush Sr., former US President at a function in Beijing on November 16, 2005. The prestigious American journal Business Week had voted Dr Mashelkar amongst the top 25 Stars of Asia. This is the first time that Business Week has honored any scientist from Asia in its Asian Star category. The journal had applauded Dr Mashelkar's role as a pre-eminent leader in Indian science and technology. His role in transforming CSIR, leading India's intellectual property movement and also redirecting science and technology suited to the developing world conditions were specially highlighted in the journal. Dr Mashelkar bags Asutosh Mookerjee Memorial Award The prestigious Asutosh Mookerjee Memorial Award has been bestowed on Dr RA Mashelkar, DG, Council of Scientific and Industrial Research for the year 2005-06. The award will be presented during the inaugural function of the Annual Session of the Indian Science Congress Association on January 3, 2006 at Acharya NG Ranga Agricultural University, Hyderabad. The award, consisting of a gold medal, perpetuates the memory of Sir Asutosh Mookerjee, the first General President of the Association and a great educationist of the country. The Indian Science Congress Association instituted this award during its Platinum Jubilee Celebration in 1988 to honor a distinguished scientist of the country every year. Indian scientists elected to ICSU Prof. Goverdhan Mehta Professor Goverdhan Mehta, former president of the Indian National Science Academy (INSA) and CSIR Bhatnagar Fellow, was elected president, ICSU at the last general assembly held at Suzhou, China. Professor Mehta is the second Indian scientist to have reached this coveted position. Professor Mehta, former director, Indian Institute of Science, Bangalore and vice chancellor, University of Hyderabad is a recognized expert in the chemistry of complex natural and non-natural products, the design of new reactions and reagents, and the use of photodynamic therapy for cancer treatment. He has published more than 300 research papers in leading international journals and has contributed to several monographs in the area of contemporary interest in organic chemistry. In addition, he has developed innovative processes and new technology for industrial applications. Professor Anupam Varma, vice-president, INSA and senior scientist at the Advanced Centre for Plant Virology, Division of Plant Pathology, Indian Agricultural Research Institute, New Delhi, has taken over as the chairman of ICSU Regional Committee for Asia and the Pacific. Professor Varma has earlier worked with FAO (UN) to develop horticultural Research Institute at Ibadan, Nigeria. He has made important contributions to fundamental and applied aspects of plant virology and developed technologies for sensitive diagnosis of the virus and virus like diseases of crop plants. He initiated work on molecular biology in India which has provided lead to our understanding of the diseases caused by Begomo, Liar, Nano, Poty and Tospo-viruses which cause more damaging diseases of plants in India. Recently he has developed transgenic cucumber, papaya, potato, and tomato for resistance to viruses affecting these crops. The International Council for Science (ICSU) was created in 1931. The Paris-based ICSU is the leading global non-governmental organization concerned with promotion of International Scientific activity in different branches of science and their applications of the benefit of humanity. As many as 101 countries of the world are affiliated to ICSU and its scientific unions. The INSA is the adhering organization in India on behalf of Government of India to ICSU. Former research head of AstraZeneca, UK joins Avesthagen Board Avestha Gengraine Technologies Pvt. Ltd. (Avesthagen), India's leading healthcare technology group focused on the convergence between pharmaceuticals, food and preventive personalized medicine has globalized its Board of Directors and Scientific Advisory Committee with the addition of Dr Barry J Furr, former chief scientific officer and head of research at AstraZeneca (UK) and Dr Simon Best, founder and chairman of Ardana Plc. (UK). Prof Barry Furr was chief scientist and head of project evaluation at AstraZeneca and a member of the senior R&D management team. He has a successful track record both in endocrinology and discovering and bringing anti-cancer drugs to the market. He has sat on committees for the MRC, BBSRC and Wellcome Trust and advises an international venture capital fund on scientific investments. While the other new board member Dr Simon Best is the founder and chairman of Ardana Plc, UK, he is also chairman-elect of the UK BioIndustry Association (BIA), chairman of the Edinburgh University Technology Fund, non-executive chairman of Neuro3D, director of the Doyle Foundation and the Hebrides Ensemble. Dr Best served as a governor of the Food and Agriculture Section of the World Economic Forum (WEF) from 1994-98. Dr Best has previously served as a member of Special Advisory Groups on Intellectual Property and Biotechnology for the World Bank. He is an Industry Adviser to BIO Ventures for Global Health (BVGH), spun out of the Biotechnology Industry Organization (BIO) with support from the Bill & Melinda Gates and Rockefeller Foundations. Jai Nagarkatti to head Sigma-Aldrich Corp The Sigma-Aldrich Corporation's Board of Directors announced the appointment of Jai Nagarkatti (president and chief operating officer) as president and chief executive officer effective January 1, 2006. He will succeed David Harvey, chairman and CEO, who will continue to serve as chairman of the company's Board of Directors. Jai Nagarkatti was also elected as a member of the Board of Directors. Jai Nagarkatti's career at Sigma-Aldrich has spanned R&D, production, operations and sales and marketing. Since August 2004, he has been chief operating officer and president. Previously he served as the president of the largest research division and the fine chemicals business. Jai Nagarkatti, a US citizen, was born in Hyderabad, India. He obtained his Master's degree in Chemistry from Osmania University in Hyderabad and subsequently a PhD in Organic Chemistry at Texas A&M University. David Harvey said, "Jai Nagarkatti is a very seasoned and knowledgeable leader who has had a major impact on the success and growth of Sigma-Aldrich. His experience and insight into our business will serve the company well as we continue our focus on life science and high technology." Jai Nagarkatti noted, "I am pleased by the vote of confidence that the Board of Directors and David Harvey have given me and I look forward to the challenge of accelerating the performance of Sigma-Aldrich and strengthening the company's position as a worldwide leader in our research and fine chemical businesses." Prof. Vijay Chandru injured in terror attack on IISc Prof. Vijay Chandru, chairman, co-founder and CEO Strand Lifesciences sustained grievous injuries on his arm on December 28, 2005, when an unidentified intruder opened fire outside Tata Auditorium in IISc, Bangalore. One person was killed and five others were injured in indiscriminate firing by the intruder outside the JN Tata Auditorium on the Indian Institute of Science (IISc) campus. The attacker, who reportedly came in an Ambassador car, opened fire at the faculty members when they were coming out of the auditorium after attending an international conference at around 7:30 pm. The attacker, who escaped after the incident, used an automatic firearm, reportedly an AK-47, for the attack. Bangalore police commissioner Ajai Kumar Singh confirmed that this was a terrorist attack. This is the first such attack in Bangalore and at IISc. Thiru P Reddy, director-business development, Strand Lifesciences told CyberMedia News that Prof. Vijay Chandru is stable. "He is stable and recovering. But he is still in the ICU," he said. He has been advised a month's rest, according to sources at Mallige Hospital in Bangalore where he is undergoing treatment. Prof Vijay Chandru, PhD MIT, is an academic entrepreneur. As a Professor of Computer Science, Vijay and three colleagues from the Indian Institute of Science founded Strand Genomics, India's first life sciences informatics company in October 2000. He currently serves as chairman and chief executive officer of the company. Prof.Vijay Chandru also holds the position of general secretary of the Association of Biotech Led Enterprises (ABLE). He serves on the board of directors of PicoPeta Simputers Pvt Ltd and MosChip Semiconductors. Prof.Chandru was part of the team that founded the hand-held, Linux-based Simputer. The entire biotech fraternity and BioSpectrum wish Prof. Chandru a speedy recovery. ]]> <![CDATA[Swiss public not for GE crops]]> https://biospectrumindia.com/news/95/1091/swiss-public-not-for-ge-crops.html https://biospectrumindia.com/news/95/1091/swiss-public-not-for-ge-crops.html Fri, 06 Jan 2006 10:17:00 +0530 Swiss public not for GE crops Swiss public not for GE crops In a referendum, the Swiss public voted in favor of a national ban on growing genetically engineered (GE) crops for five years. "Switzerland, the homeland of genetic engineering giant Syngenta, is clearly unwilling to risk health, food security or the environment by allowing crops to be genetically engineered. Today's GE crop ban will help defend against these risks but will not provide full protection," said Yves Zenger from Greenpeace Switzerland. GE field trials will still be allowed under the new moratorium and products deriving from animals fed on GE crops can still be imported into the country. Pending applications for GE food and animal feed could also still be approved. A new opinion poll released by Greenpeace shows that the majority of Swiss people want the moratorium to go further because they are not only against GE crops but also reject GE food and believe field trials are risky. A vast majority also wants mandatory labelling of any products derived from animals fed on GE crops. "Greenpeace hopes Switzerland's rejection of GE crops inspires others around the world to stand up and say 'no' to genetic engineering. We also encourage the Swiss public to continue to voice its opposition to this highly risky technology. Every route of contamination must be closed before people can rest assured their plants and the food on their plates is not contaminated," said Geert Ritsema, Greenpeace International GE campaigner. BII launches e-learning courses Delhi-based Bioinformatics Institute of India (BII) has made available its various certifications online with the launch of "BII Online" an enhanced system of providing e-Learning via internet. To start with all the specialized courses in biomedical sciences have been incorporated and can be joined by aspiring students. The site comprises of additional features like live virtual classroom demo, custom solutions, learning methodologies, online store, etc. Puneet Mehrotra, director, Bioinformatics Institute of India, said, "The goal of BII Online is to be a leader in developing and providing quality online programs using the latest distance learning technology. The Institute's online programs were developed to serve a constituency of students with life constraints preventing them from attending campus-based classes. These eLearning programs provide maximum flexibility without compromising learning outcomes or academic rigor." Ban GM food crops: Greenpeace Greenpeace has unveiled a "biohazard hotspots map" revealing the scale of field trials of genetically engineered (GE) food crops in India. Its activists met the union health minister, Dr Anbumani Ramadoss and pointed out the urgency with which the ministry of health must step in and focus on health impacts of GE food. In this context, Greenpeace also met with officials at the Indian Council of Medical Research (ICMR) who shared with the activists the minutes of a meeting of the Expert Committee on Genetically Modified (GM) Food held on September 6, 2005 at ICMR headquarters, New Delhi. The ICMR officials have further asked Greenpeace to provide inputs into the document. Although Greenpeace has welcomed the process of open consultations and is studying the document, it reiterated that open-air field trials of GMOs are going on and the current system is woefully inadequate to combat runaway contamination. Greenpeace cautioned that inspite of ICMR's best intent and recommendations, the regulatory machinery will lag behind in its ability to prevent GMO proliferation from existing open-air field trials of GM foods which could lead to food contamination. It has demanded a ban on all field trials of GE food crops in the country; all data on ongoing field trials of GE food be made public; and the new biotech policy be reoriented to focus on biosafety concerns and risks to health caused by GE foods. HCL jointly launches Panax finder HCL Technologies, a leading global IT solutions provider in Information Technology and Saila Systems Inc., Japan have launched Panax Finder, a statistical analysis software package which can be used by pharmaceutical companies in the drug discovery process. Saila Systems is one of the leading IT solution companies in Japan providing a range of services from software requirement analysis to systems supports jointly. This software will help pharmaceutical companies to identify the properties of the drug and predict its efficiency even before its synthesis, thereby gaining tremendously on time. Pradep Nair, vice president and head â€“ Life Sciences Practice, HCL, New Jersey, USA said, "With the increasing maturity and complexity in IT environments today, we felt the need to provide our customers a tool that would reduce time inefficiency in drug discovery caused due to multitude of possibilities in which compounds can combine and synthesize and help them in saving cost." ACCUFORD Tri-Tstat reagent kit launched ReaMetrix and Millipore India have announced the release of the ACCUFORD Tri Tstat reagent kit. The kit enables a critical test for the management of AIDS patients to be available at a reasonable cost. ReaMetrix's goal for the test is reduce the cost to measure of the strength of a HIV patient's immune system and allow them to be tested more frequently. Through this diagnostic, doctors will be able to assess when to begin drug therapy for AIDS and the effectiveness of that drug therapy. The reagent kit provides the consumables for the enumeration of a patient's T-cells on a flow cytometer. The key component of this test are fluorescently-labeled monoclonal antibodies. While the raw materials for the test are imported from established suppliers in developed nations, the process for creating a clinically seful kit is carried out entirely in India. The reagent kit will be developed and manufactured in India by ReaMetrix and marketed by Millipore India. Sun Pharma acquires Able Labs Sun Pharma, a speciality pharma company, has successfully completed the purchase of dosage form manufacturing operations of Able Labs in the US for $23.15 million by its wholly owned subsidiary company, Sun Pharmaceutical, Michigan. The US Bankruptcy Court of the District of New Jersey, Trenton, had accepted the Sun Pharma bid as the highest, earlier this year. These assets include ownership and lease rights to manufacturing operations at two sites in New Jersey, with total 275,000 sq.ft. floor area, including special suites for the manufacture of controlled substances. The purchase also includes intellectual property for the products being marketed by Able until it was required by the USFDA to withdraw these earlier this year, as also products under approval. Sun Pharma will evaluate and revalidate these dossiers and resubmit selected products with the USFDA. These products, on launching, are expected to make a significant addition to the company's US generic business. This is Sun Pharma's fourth acquisition in the US, the other three being the acquisition of Caraco in 1997, the acquisition of two brands from Women's First Healthcare in 2004, and the purchase of a dosage form plant at Bryan, Ohio earlier in September this year. Caraco's business was built from sales of $ 0.8 million in 1997 to over $ 60 million in 2004. Sun Pharma continues to evaluate further acquisition opportunities in the US. Glenmark signs pact with InvaGen Mumbai-based Glenmark Pharmaceuticals Ltd and US-based InvaGen Pharmaceuticals, entered into a collaboration agreement for the joint development, filing and marketing of seven generic pharmaceutical products for the US market. The product list includes a mixture of off-patent and patent-protected molecules with cumulative annual sales in the US of about $4.1 billion. As per the agreement, InvaGen will develop and license to Glenmark, seven generic products. InvaGen will also undertake filing the ANDAs while Glenmark will be responsible for obtaining regulatory approval in the US market. Upon approval, Glenmark's US subsidiary, Glenmark Pharmaceuticals, will exclusively market the products while InvaGen will be responsible for their manufacture and supply. All development and regulatory costs and profits on sale in the US will be shared equally between Glenmark and InvaGen. Of the list, one ANDA has already been filed till date and three more are expected to be filed by March 2006. SPI Pharma launches India operations SPI Pharma, a fully owned subsidiary of Associated British Foods company and a worldwide leader in custom formulation solutions for pharmaceutical manufacturers, has commissioned a full-fledged drug development and testing center in Bangalore. The development center is housed in a 16,000 sqft. building with room for expansion located at Veerasandra Industrial Estate. The facility was inaugurated by Dr Venkateswarlu, deputy drugs controller of India, recently. SPI operations in India are scheduled to begin by January 1, 2006. The work will involve drug development and discovery. John Burrow, CEO, SPI Holdings said, "With India fast becoming a scientific powerhouse in the global pharma market, this new facility is significant to our operations in India. SPI Pharma will be in a position to speed up customized projects using several of its proprietary excipients and delivery platforms. SPI's strategy in India is to develop and test finished drugs using its proprietary drug delivery technologies as well as those acquired through strategic partners." Rana Kayal, president SPI Pharma said, "SPI's major strengths are functional modification of pharmaceutical materials and enabling drug delivery technologies. SPI Pharma has made an investment of over Rs 4 crore in this new facility and plans to increase it based on the needs of the clients. Our products will be made available to pharma companies around the globe. We are currently working with companies like Cipla, Novartis, Pfizer and Dr Reddy's in India. We are also in discussions with major API producers like Matrix and Biocon," he added. NPIL signs pact with Pfizer International Nicholas Piramal India Limited (NPIL), has signed a long-term contract manufacturing related R&D services agreement with Pfizer International LLC. The agreement is for a period of seven years, and is renewable thereafter. Strides gets RBI go-ahead for FII holding Strides Arcolab Ltd, a Bangalore-based pharma company has received permission from the Reserve Bank of India permitting the Foreign Institutional Investors (FIIs) to hold up to 49 percent of paid-up equity capital of the company. FII holding in the company's scrip had reached the previously approved limit of 24 percent. Monsanto to import parental lines of transgenic corn Monsanto India Ltd has received approval from Genetic Engineering Approval Committee (GEAC) to import parental lines of herbicides tolerant corn to carry out research in the country. It will import transgenic corn seed (250 gm), 50 gm each of four inbred lines and one single cross from Monsanto Republic of South Africa subject to certain conditions. The conditions are as follows: the import of transgenic corn seeds shall be exclusively for the purpose of research and shall be carried out in accordance with conditions and safe guards stipulated by the Review Committee on Genetic Manipulation (RCGM) and National Bureau on Plant Genetics and Research (NBPGR), the authorized agencies for granting permission to import transgenic materials for the purpose of research; the research proposal shall have the prior approval of RCGM before initiating the research activity; the clearance will not be treated as blanket approval for product development. The product development if any shall be done in accordance with the procedure prescribed by RCGM and GEAC. Opto Circuits acquires German firm Opto Circuits (India) Ltd (OCIL), a manufacturer of non-invasive healthcare equipment based in Bangalore, has completed the acquisition of EuroCOR GmbH, a German company that designs and manufactures various kinds of stents. The acquisition has been valued at Euro 11 million (Rs 59.91 crore). Announcing the acquisition, Vinod Ramnani, chairman and managing director, OCIL said, "This acquisition of EuroCOR gives us a strong foothold in the global arena for stents. The total global market for stents was valued at $6 billion in 2004 and is expected to rise at $10 billion by 2008. Whilst we are barely scratching the surface now, we expect that the strong R&D base of EuroCOR will lead us in the direction of greater market share and also better margin business. This acquisition is another milestone in the history of the growth of Opto Circuits, and will help improve shareholder value." Bharat Serums gets US patent Bharat Serums and Vaccines Limited (BSVL) received a US patent for its novel formulation Amphotericin B Emulsion. All the excipients used for this formulation are US FDA approved for injectable formulations. According to an official press release, comparative tests on animals have shown this formulation to be many times safer than any of the existing Amphotericin formulations. Amphotericin B has been considered to be the gold standard in the treatment of fungal infections. However, Amphotericin is highly nephrotoxic, which limits the usage of the drug. Despite introduction of newer anti-fungal formulations into the market, there continues to be an interest in Amphotericin formulations â€“ primarily due to the fact that over a period of time, the fungi build resistance to the anti-fungal agents. BSVL has already received the marketing permission for this drug in India for Visceral Leishmaniasis and is in process of conducting clinical trials for obtaining the permission in treatment of fungal infections. BSV has also conducted a Pre IND (Investigational New Drug) meeting with the US FDA for the clinical path and is in the process of filing the IND by QI 2006. The present anti fungal market is in excess of $2 billion out of which the various Amphotericin formulation have a market share of in excess of $300 million. BSVL expects that a safer Amphotericin formulation would be in a position to capture a substantial share of the global anti fungal market. ]]> <![CDATA[Dr Bhan moots Indo-US innovation forum to spur growth in biotech]]> https://biospectrumindia.com/news/95/1069/dr-bhan-moots-indo-us-innovation-forum-to-spur-growth-in-biotech.html https://biospectrumindia.com/news/95/1069/dr-bhan-moots-indo-us-innovation-forum-to-spur-growth-in-biotech.html Fri, 06 Jan 2006 10:15:00 +0530 Dr Bhan moots Indo Dr Bhan moots Indo-US innovation forum to spur growth in biotech A clarion call to expedite work on building appropriate infrastructural facilities -streamlined, efficient importation processes for bio-pharmaceutical products, dedicated port facilities with cold storage capability, specialized testing facilities and clear and transparent processes was given at the Biotechnology session of the High Technology Cooperation Group (HTCG) meeting held in Delhi. Dr MK Bhan, secretary, DBT, said, "We are at the beginning of the biotechnology development process. It is critical to create a balance between basic science and translational science, for which the government is ready to invest in research and development." He informed the audience that the biotechnology strategy is ready to go to the Cabinet soon. Lauding the efforts of the US in the field of innovation, Dr Bhan said that due to strong institutional mechanism and structures, the US has been able to keep ahead in the field of biotechnology. He urged the business delegates from the US to increasingly share their eaxperiences and give technical support. He further suggested that the US can be an incredible partner to India as 70 percent of the biotech material is possessed by them. He stressed that there is a need to form a micro group if one is seriously looking at deliverables through trade in biotech between the US and India. He also proposed that there is a need to create an Indo-US innovation forum to spur growth in the sector. Dr Bhan also pointed out the need to have a point person to coordinate the efforts of the HTCG in a manner which enhances the overall accountability of concerned people in India and the US. Nigel Thompson, executive director, Economic and Development Strategy, Merck highlighted how important it was to incentivize the innovation process in order to unlock the potential for entrepreneurship and innovation in life sciences. He pointed out that India must address and clarify the issues of scope of patentability and compulsory licensing. Data protection needs to be implemented in accordance with international norms. He added that the complex challenge lies in the issues of investment in innovation, bringing healthcare to people who need it. For this, there is the need to have a broad dialogue and consider processes involving key stakeholders. Echoing Dr Bhan's sentiments, he suggested that there is an urgent need to set up a committee which would work on the details in a focused manner. Dr Rama Mukherjee, president (R&D), Dabur Research Foundation highlighted three areas where India can contribute. She said India has the potential to come up with solutions in the area of cancer, malaria and avian influenza (bird flu). She pointed out that Dabur's focus is on developing cancer vaccine, redevelopment of anti-cancer drugs using nanoparticle/nanocell technology. She added, "In another two-three years we hope to have few clinical trials." She urged the US companies to join hands to control influenza pandemic and versions of mutated virus by developing therapeutic vaccines. Dinesh Dua, co-chair, FICCI Biotechnology committee and president, biotechnology, Wockhardt Ltd, stressed that it is critical to move towards synergistic model with India and create national strategies to fight diseases like cancer, malaria and influenza.There is urgent need to expedite synergy between the US and Indian companies particularly in pharmacology and biotechnology, Dua added. Govt to set up IPR management institute with WIPO aid The government has proposed the establishment of a National Institute of Intellectual Property Management to address the issues of training, research and policy formulation, to facilitate a fair, equitable and world-class system of patenting in India. Speaking after inaugurating a two-day national seminar on on "Enhancing Global Competitiveness of Indian Life Sciences Industry through the Strategic Use of the Patent System", organized by WIPO, DIPP and FICCI, Dr Ajay Dua, secretary, department of industrial policy and promotion (DIPP), said, "We are in serious discussion with WIPO to create an IP management institute that imparts the requisite skills to IP managers for the corporate sector, attorneys and lawyers, addresses sponsored research work in the IP field and builds up a policy think tank for handling IP issues." Such an institute, combining all the three aspects in IP management, would be the first of its kind in the world, he said. Dr Dua said, "the scope and management of IP would need to evolve along with the research and patenting requirements of biotechnology, pharmaceuticals and drugs, even as "it has become imperative to bring our traditional knowledge in the public domain so that due credit is accorded to the communities and people who have contributed to creating a body of scientific knowledge." Jay Erstling, director, Office of the Patenting Cooperation Treaty (PCT), WIPO, said the PCT, of which India is a signatory and a valuable partner, provides simple, cost-effective and time-saving solutions based on best practices to member-countries as inventions get commercialized and disputes in IP arise. In this context, he emphasized the need for settling commercial disputes amicably through the alternative dispute management system developed by WIPO. DST secretary outlines four-point agenda for Indo-US nanotechnology projects Prof. VS Ramamurthy, secretary, department of science and technology (DST) outlined a four-fold prescription to the High Technology Cooperation Group (HTCG) to give an impetus towards initiating Indo-US nanotechnology projects. Addressing the HTCG Dialogue on nanotechnology, Prof. Ramamurthy called for setting up an Indo-US center on computational material sciences with special reference to nanotechnology, the US help in the establishment of a nanotechnology center in India, facilitation of the US nanotechnology enterprises to use ACRI, Hyderabad facilities, including incubator space and creation of a bi-national small business incubator fund. He outlined India's priority requirements in the field of nanotechnology as investment, trained human resources, innovation and research and interface between industry and research institutions through public-private partnerships. Mike Roco, senior advisor for nanotechnology, National Science Foundation, USA said the National Nanotechnology Initiative (NNI), a federal R&D program was established to coordinate the multi-agency efforts in nanoscale science, engineering, and technology. The goals of the NNI are to maintain a world-class R&D program aimed at realizing the full potential of nanotechnology; facilitate transfer of new technologies into products for economic growth, jobs, and other public benefit; develop educational resources, a skilled workforce, the supporting infrastructure and tools to advance nanotechnology; and, support responsible development of nanotechnology. Area of concern is IPR, says knowledge industry Intellectual Property Rights (IPR) remain an area of concern for the knowledge-based industry, felt participants at a session on "From Brains to Business: Future Knowledge-Based Industries" during the India Economic Summit 2005, jointly organized by World Economic Forum and Confederation of Indian Industry. While India has enacted laws to safeguard IPR, their implementation remains poor. The government and consulting organizations can give advice on patent registration, especially in cultures where copying is rife, said Michael A Cooke, president, SAS International, Germany. He said India's international capabilities in marketing and branding need to be better projected to attract foreign direct investment (FDI). India should apply know-how and skills from IT to bio-informatics to engineering in order become a lead player. IT has attracted the best Indian engineers and adopted intellectual property rights (IPR), transparency and governance norms, as appropriate. The IT sector had developed best practices on IPR and patents, and other sectors such as biotechnology could learn from it, said Venkatesh Valluri, president and country general manager, Agilent Technologies, India. In addition, the IT industry could offer valuable insights on how to attract bright Indians settled abroad. Further, the biotechnology industry also needs to make use of the government infrastructure, most of which is under-utilized and collaborate with educational institutes to build a talent pool that will deepen research by funding common themes. S Mahalingam, CFO, Tata Consultancy Services, India, said IP protection was essential to attract suitable human resources. The biotechnology industry requires doctoral-level professionals in order to grow. It also needs to address wage differentials between India and the West. "It should create centers of excellence," he said. The IT industry, he said, had grown without a domestic market but biotechnology can grow on the strength of the domestic market. For this, the government has to enforce existing laws and institute labour reforms. SRL Ranbaxy launches national mass screening program to wage a war against Hepatitis B SRL Ranbaxy, a leading pathology laboratory service provider, has launched a first-of-its-kind national mass-screening project for Hepatitis B amongst school students. Teaming up with Lions Club International, the project, in its first phase, aims to screen and diagnose over 1 lakh school students in Chennai against the deadly Hepatitis B virus. The program was initiated at Shrimati Ramkumar Devi Fomra Vivekanand Vidyalaya, Crompet, wherein SV Shekhar, Chennai's popular stage performer and a social worker, motivated more than 1500 students, from classes VI to VIII for the Hepatitis B screening by SRL Ranbaxy experts. Bringing to light some alarming facts on Hepatitis B prevalence, VS Venkatesh, director, sales and marketing, SRL Ranbaxy said, "Out of an estimated 43 million Hepatitis B infected Indian population, nearly 90 percent are 'unaware carriers' and they do not even know that they carry the infection and can spread it further. Furthermore, the prevalence of Hepatitis B is highest amongst the younger age group. Estimates also suggest that 5 percent of the infants carry a probability of picking up the infection from their mothers. These facts clearly establish the criticality of timely and accurate diagnostics - and that too amongst the younger audience if we have to nip this disease in its bud. SRL Ranbaxy decided to employ its expertise to this cause and team up with Lions Club to diagnose school students and create awareness amongst them as well as their families. Whatever the numbers of families that this initiative brings life and new hope to, we would have achieved our objectives." As part of the campaign, SRL Ranbaxy will employ its specialists and global level quality protocols for accuracy testing. The test reports would be delivered to the students the next day with further counseling, if needed. Speaking on the occasion, K Bhaskar, governor, Lions Club International said, "Lions Club Chennai has always stood by its citizens, bringing in relevant experts and joining them in several social issues. The estimated prevalence of Hepatitis B in Chennai is an alarming level of more than 6 percent of entire population and if corrective diagnostic action is not taken right now, it could turn out to be an uncontrollable epidemic. It was at this juncture that SRL Ranbaxy approached us and given the fact that they have a national network and international quality systems, we were honored to team with them in this critical project." Post successful implementation in Chennai, SRL Ranbaxy and Lions Club would analyse the feasibility of extending this campaign to other states and carry this revolution against Hepatitis B to all shores of the nation. Shasun Chemicals to conduct clinical trials with r-Streptokinase The Genetic Engineering Approval Committee (GEAC) has given permission to Chennai-based Shasun Chemicals & Drugs Ltd to conduct clinical trials with ('Streptokinase â€“A') developed by it in India. Shasun Chemicals has proposed that it will conduct a multi-center, prospective, randomized, parallel design, double blind study to evaluate the efficacy and safety of Streptokinase â€“A in the treatment of acute ST elevation of myocardial infarction at five centers - Chennai, Madurai, Bangalore (two centers) and Pune. The total number of patients to be tested is about 120. The GEAC further noted that pre-clinical animal toxicity studies have been examined by the Review Committee on Genetic Manipulation (RCGM) wherein the committee noted that the product is found to be safe. The committee further noted that the product r-Streptokinase is a drug approved for marketing in India. After detailed deliberations and taking into consideration the recommendation of RCGM and the expert members, the committee approved the conduct of clinical trials with ('Streptokinase â€“A') developed by Shasun Chemicals in India. Mashelkar unveils four-fold strategy to create strong national innovation system Dr RA Mashelkar, secretary, Department of Scientific and Industrial Research (DSIR), called for a four-pronged strategy to create a strong national innovation system by leveraging India's human talent, building the capacity and competence of public research institutions, employing traditional knowledge to create Intellectual Property and developing a hassle-free environment to enable companies to take competition head on. Inaugurating the 19th National Conference on "In-House R&D in Industry: Managing Technology for Competitive Advantage - Emerging Indian Challenge," organised jointly by DSIR and FICCI, Dr. Mashelkar said, "We need to worry about the fact that India does not figure in the top 10 emerging nations in terms of R&D investment by business. It is imperative that as enterprises develop their own capacities, the government chips in through enabling policy and investments and forges public-private partnerships to enable India join the big league and be counted. Dr Mashelkar and the FICCI president, Onkar S Kanwar gave away the DSIR National R&D Awards for 2005 to 11 companies in nine categories. These include: Gujsynth, Vapi and IPCL, Vadodara, (chemical and allied Industries); Matrix Laboratories Ltd, Secunderabad (drugs and pharmaceutical industries); Sri Biotech, Hyderabad (biotech industries); Transasia Bio-Medicals Ltd, Mumbai (electronic/opto electronic industries); Maharashtra State Seeds Corporation Ltd, Akola (agro food processing industries); SAIL (new materials); Praj Industries Ltd, Pune (technology exports); Reliance Industries Ltd, Hazira (technology absorption) and BEL, Bangalore and Rasi Seeds (P) Ltd, Attur ( successful commercialisation of technology acquired from others). Dr Mashelkar said, the emerging role of knowledge in the new economy "gives us the confidence that India would occupy a position of leadership" as currently 50 per cent of GDP of advanced countries comes from the knowledge sector. Clinical research will be built into medical school system: Dr Bhan The Indian Council of Medical Research (ICMR) and the ministry of science and technology have taken on hand a massive program of transforming the medical school research system, under which, in the next five years, clinical research will become part of the curriculum of medical schools. This would go a long way in producing skilled, motivated and ethical professionals in the vital area of biotechnology research. This was stated by Dr MK Bhan, secretary, DBT, while addressing the inaugural session of the three-day Bio-Business Summit 2005 â€“ "Global Clinical Trials in India: Challenges and Opportunities", organised recently by FICCI, Department of Biotechnology, Ministry of Health & Family Welfare and ICMR. Dr Bhan said it was imperative to put in place human resources creation strategies for clinical research in India along with a proper assessment of the optimal training needs for personnel engaged in such research. "Unfortunately, the industry is still not able to pinpoint the changes that need to be brought about in this crucial area", and therefore it was necessary to create a permanent think tank comprising the best brains of India to prepare documentation for the Drug Controller General of India (DCGI) for assisting the directorate in creating a facilitatory environment for research and drug discovery in the country, Dr Bhan said. The minister of state for health and family Welfare, Panabaka Lakshmi pointed out that good clinical practices as well as ethics to be followed while conducting clinical trials have to be a shared responsibility of sponsors, clinical investigators, ethics committees and the regulatory bodies. "As our share in global clinical research increases, the challenges would have to be met along with the opportunities thrown up by this intellectual activity. The need of the hour is to identify the deficiencies and prepare for the challenges much in advance and to address them in a speedy and effective manner," the minister pointed out. Critical bill on lines of Bayh-Dole Act likely in Budget session in 2006: Sibal Kapil Sibal, minister for science and technology, has acknowledged the need to revolutionise the R&D scenario in India by emulating the Bayh-Dole Act, 1980 of the US. He was addressing the two-day global summit on India R&D 2005, organised by FICCI. The Patent and Trademark Law Amendments Act more commonly known as the Bayh-Dole Act addresses the critical issue of technology transfer of research results from the universities to the commercial market place for public benefit. With the passage of the Bayh-Dole Act, colleges and universities immediately began to develop and strengthen the internal expertise needed to effectively engage in the patenting and licensing of inventions. This Act provided the strong incentive for university-industry research collaborations. The minister outlined his vision towards creating a similar incentivized atmosphere in India between universities and the industry and said that all efforts will be made to put in place a bill on the lines of the Bayh-Dole Act in the Budget Session in early 2006. It is notable that before the passage of the Bayh-Dole Act, fewer than 250 patents were issued to the US universities each year. Sixteen years later in 1996, universities received more than 2,000 new patents, executed nearly 2200 licensing agreements, and received royalty income from licensing of $242 million. Since 1980 more than 1500 start-up companies have been formed based on technologies discovered at academic institutions. In India, a similar Act is likely to boost R&D efforts and promote technology transfer by creating incentives for university researchers to consider the practical applications of their discoveries, and for universities to search out potential companies to develop them. It is expected that an Act on the lines of the Bayh-Dole will enable corporations to negotiate exclusive licenses of promising technologies. Serum Institute launches Td-Vac for adults and adolescents Serum Institute of India Ltd, India's largest vaccine manufacturer, has launched Td-Vac, India's first indigenous Tetanus and Diphtheria vaccine for combating the fatal Tetanus and Diphtheria (Td) in adolescents and adults. Td-Vac is priced at Rs 7.50. It provides safety against Diphtheria and Tetanus (Td), while the Tetanus (TT) vaccine is priced at Rs 6.50. With this vaccine the patient receives protection against two diseases at the cost of just one. According to an official press release, the Td vaccine is different from the normal DT (dual antigen) vaccine used in children. This new Td vaccine will replace the existing usage of TT (Tetanus) vaccine, which is normally given post-injury. Every person traveling to the US has to prove that he has received Td vaccine dose. In several countries, including the US, pregnant women are administered with Td (Tetanus and Diphtheria) vaccine instead of the TT (Tetanus) vaccine. The Indian Academy of Paediatrics (IAP) recommends the use of Td vaccine in all individuals over the age of 7 years. Dr Cyrus S Poonawalla, chairman, Serum Institute of India Ltd. said, "Serum Institute has always looked at launching international standard life saving vaccines in the Indian market. Health authorities in the western countries advise the use of Td (Tetanus and Diphtheria) vaccine instead of the TT (Tetanus) vaccine. Now, with the launch of Td-Vac, we are yet again offering the Indian masses the benefit of two vaccines in one, and which is the norm in developed countries." Shantha Biotechnics to conduct Phase III trials of Pentavalent vaccines After the successful launch of its quadravalent vaccine Shantetra, Hyderabad-based Shantha Biotechnics will now conduct Phase III clinical trials of r-DTwPHb-Hib Pentavalent Combination Vaccine. Shantha Biotechnics received the green signal from the Genetic Engineering Approval Committee (GEAC) at its meeting held on November 23, 2005. Pentavalent Combination Vaccine is for a paediatric use in immunization program. Pentavalent vaccine contains Diphtheria (D) and Tetanus toxoids (T) and the purified major surface antigen of the hepatitis B virus (HBV), Hib polysaccharide adsorbed on aluminum salts and mixed with inactivated whole cell pertussis (P). Shantha Biotechnics proposes to conduct a multi-centric, randomized, single blind, three arm study to compare the immunogenicity and safety of indigenously developed DTPwHB-HIB (Liq) Pentavalent combination vaccine with Easyfive (Liq) and Tritrantrix + Hberix in about 400 children. The route of administration is intra-muscular injection and duration of the study period per subject will be 12-15 weeks. The Review Committee on Genetic manipulation (RCGM), which has examined the pre-clinical animal toxicity studies, noted that product is found to be safe. Taking into consideration the recommendation of RCGM, GEAC has given permission for Shantha Biotechnics to conduct clinical trials with Pentavalent Combination Vaccine. Concordas to expand Concordas, the professional services company serving the life sciences industries, is now looking at expanding its operations and has initiated a recruitment drive for its Indian operations. It offers opportunities to graduates of science, pharma and management and to statisticians and market researchers with a flair for consultancy. Concordas is providing services to clients across Europe, US and India. Recent projects have included the evaluation of market characteristics and dynamics of various therapeutic areas in the US for international clients, a series of commercial due diligence evaluations for European specialty pharmaceutical companies, and outsourced marketing analytics for healthcare marketing companies. Colin Greenstreet, founder and chief executive, Concordas said, "The Indian pharmaceutical R&D scene is an exciting one. Indian companies and R&D activities are rapidly internationalizing."   ]]> <![CDATA["Take every crisis as an opportunity"]]> https://biospectrumindia.com/news/95/1319/take-every-crisis-as-an-opportunity.html https://biospectrumindia.com/news/95/1319/take-every-crisis-as-an-opportunity.html Fri, 06 Jan 2006 10:10:00 +0530 BIOSPECTRUM STUDENT LECTURE SERIES BIOSPECTRUM STUDENT LECTURE SERIES "Take every crisis as an opportunity" The third BioSpectrum Student Lecture Series organized in New Delhi at the Chandiwala Estate Auditorium on December 6, 2005, saw the enthusiastic participation of as many as 230 students from across the National Capital Region (NCR). The event was sponsored by Amity Institute of Biotechnology, Noida. The Student Lecture Series is an event where leading personalities from across the industry address biotechnology students' queries on higher education, careers and opportunities in the biotech arena. BioSpectrum embarked on the country's First Public Lecture Series on Biotechnology for students and launched the event in Bangalore in July this year. Appraising the students about the role of the government scientific departments/agencies in the area of modern biology, Dr GJ Samathanam, director, Department of Science and Technology, said, "There are 12 scientific departments under the Government of India and of which three viz. Department of Science & Technology (DST), Department of Biotechnology (DBT) and Council of Scientific and Industrial Research (CSIR) of the Ministry of Science & Technology play a very active role in nurturing the frontier areas of research on biotechnology including the international cooperation in this arena." There are many programs for young scientists floated by the DBT and DST in life sciences sector, he informed. "You should take every crisis as an opportunity, develop a curiosity to learn on a daily basis and do better benchmarking for higher education", Samathanam advised the students. Ashish Jain, head - BioAnalytical Research, Jubilant Clinsys, outlined the various options available for students in the clinical research sector. Explaining the various services provided by a Contract Research Organization (CRO), he said, "Today the focus is on the preclinical, clinical and data management areas. Phase I (early and late) Phase II, Phase III, Phase IV and Bioequivalence studies are the critical part of any clinical trial." Elaborating on the job categories in the sector, he commented, "Business development manager, regulatory affairs manager, documentation manager, finance manager, project manager, software engineer, instrumentation engineer are the options available in the administrative sector whereas as bioanalyst, research manager, pharmacist, clinical research associates, biostatistician, study co-coordinators, pharmacologist, data manager, molecular biologist, study custodians, phlebotomist, medical writers, biochemist, toxicologist, formulation manager, biologist and enzymologist are the job categories in the technical sector." He further went on to explain in brief the role and responsibility of some of the job positions. Amity Institute of Biotechnology was the academic partner for the event. Prof. AK Srivastava, dean and coordinator, Amity Institute of Biotechnology exhorted the students to focus on research and developing laboratory expertise during their course curriculum. He felt that students should try to work on research projects while pursuing their degree program "as this will enhance your skills and knowledge of the subject." The speakers addressed various queries of the students, which were mainly related to the future scope of the subject and job opportunities in the industry. On its part, BioSpectrum announced 5 lucky winners for complimentary subscription to the magazine for a year and encouraged the students to send in their questions and comments to the magazine. Rolly Dureha ]]> <![CDATA["Become complete professionals"]]> https://biospectrumindia.com/news/95/2192/become-complete-professionals.html https://biospectrumindia.com/news/95/2192/become-complete-professionals.html Fri, 06 Jan 2006 10:08:00 +0530 BIOSPECTRUM STUDENT LECTURE SERIES BIOSPECTRUM STUDENT LECTURE SERIES "Become complete professionals" The fourth BioSpectrum Student Lecture Series held at the Institute of Chemical Technology, Mumbai on December 10, 2005, evoked good response from the student community. As many as 340 students participated in the event which was inaugurated by Prof. MY Kamat, head, Food and Fermentation Technology, Institute of Chemical Technology (ICT), University of Mumbai. The event was sponsored by Padmashree Group of Institutions. In his inaugural address, Prof. Kamat gave a call to students to emerge as complete professionals to serve the society better. Stressing on the need to fill the gap between science and technology, from laboratory to industrial scale, he said, "The Indian industry is facing problems with regard to yield and recovery of bioproducts. And purification of biomolecules account more than 80 percent of the production cost. Hence it requires research in special techniques of purification and isolation. To bridge this gap, ICT has been offering an MTech course in Bioprocess Technology, where the potential is tremendous for the benefit of mankind." Industry experts like R Subramanian, general manager, Transasia BioMedicals, SS Adkar, senior manager - biotech, Rossari Biotech, Ravi Limaye, vice president - business development, marketing and commercial strategy, GlaxoSmithKline, shared their experiences. They also spoke about the opportunities in their core areas of operations. Highlighting the opportunities in the diagnostics sector, Subramanian said "Lifestyle patterns are changing in the country. The incidence of lifestyle diseases such as diabetes and cardio-vascular diseases is on the rise. The country needs almost 80,000 additional hospital beds every year for the next three to four years to adequately meet growing healthcare demands. Private healthcare companies are looking at tapping this huge market that is estimated at $18.7 billion. The industry is growing at about 13 per cent annually and is expected to grow at 15 per cent over the next four to five years. Hence India is a land of opportunities." Sudheer S Adkar noted that the global demand for industrial enzymes in 2004 was $2.5 billion with an annual growth rate of 5â€“10 percent. Hence the thrust of the firms was to develop efficient strains with GM tools and to optimize downstream processes in terms of costs and technologies. "Young students with proper training and exposure stand better opportunities in this arena as the companies are looking for trained manpower," he added. In his presentation on "Biotechnology â€“ the future is bright", Ravi Limaye observed that the market trends showed a clear shift towards biotechnology driven specialty products. "This is because they have potential for longer life cycles than primary care products and of lower risk of generic exposure. There is huge potential for India in the area of clinical research and in global R&D value chain. The country has a significant treatment naÃ¯ve patient base, English-speaking people, more hospitals, scientific pool, doctors etc." Exhorting students to take up short-term courses in biotechnology, Rajesh Shenoy, principal, Padmashree Institute, said biotech companies were now looking for ready-to-start kind of candidates. "Keeping in mind the requirements of the industry, our institute has developed a short-term certificate course in Molecular and Animal Cell Culture Techniques. The course gives a hands-on experience on various preparative as well as production tools." Later, students from UICT, Bhavan's college, KET's VG Vaze college, Birla College of Science and Arts, Royal College, Jhunjhunwala College, Welingkar Institute of Management and Research, SIES college, Ruia college, KJ Somaiya college and Rai Foundation participated in an interactive Q&A session. Narayan Kulkarni     ]]> <![CDATA[National Regulations Should Reflect Risks of GE Crops]]> https://biospectrumindia.com/news/95/2011/national-regulations-should-reflect-risks-of-ge-crops.html https://biospectrumindia.com/news/95/2011/national-regulations-should-reflect-risks-of-ge-crops.html Fri, 06 Jan 2006 09:57:00 +0530 Arpad Pusztai Scientific Consultant to GenOk Arpad Pusztai Scientific Consultant to GenOk, Tromso, Norway National Regulations Should Reflect Risks of GE Crops Engineered artificial gene constructs may undergo mutation and evolution to an end, therefore making the safety assessment of GE crops an exercise without a firm predictive scientific basis. Acceptance of products and associated agricultural practices of the biotechnology industry is running into problems, probably due to the perception held by many scientists that the technical ability of biotechnology industry to produce safe genetically engineered (GE) crops has developed faster than the understanding of the underlying scientific principles of gene splicing. Consumers and scientists alike feel that the possible consequences for health and environment of the spread of GE crops are not properly understood and that without sufficient research funding and having generally agreed methodologies for assessing the unique risks of GE crops, we shall never be able to properly address them. It should not be surprising that societal concerns about genetic engineering of something as basic as our food and how they are produced are high and no matter of patronizing platitudes by the scientific, political and industrial establishments will make these concerns to go away. Bizzare approach The approach of the biotechnology industry to the safety of its products or the understanding how society perceives risk is bizarre. The harsh treatment of sceptics and dissident scientists does not demonstrate the establishment's great willingness to listen to views not in tune with their pre-set ideas. Openness is not much helped either that due to the high cost of biological testing, biotechnology companies only do minimal and superficial environmental and health risk assessments. Cost will also be a major factor in their reluctance to finance research to develop scientifically sound methodologies but rather they prefer to declare the present agricultural practices to grow GE crops as safe and that foods prepared from them present no risks for the consumer. The fact that in the decade since the introduction of GE crops only one human feeding study has been conducted and basic academic animal nutritional/toxicology studies published in peer-reviewed journals are also few and far between gives plenty of ammunition to those who oppose GE crops. Presently there is an intensive scientific and legislative debate in many countries, including India, about the possibility of the large-scale growing of GE crops without jeopardizing the GE-free status of organically or conventionally grown crops. Pro-industry scientists advocate that even with cross-pollinating crop species only a few metres of separation distance between GE and non-GE crops will be adequate to prevent genetic pollution. However, in the laboratory to prevent the escape and proliferation of untested experimental GE organisms, all developmental work is strictly contained. Moreover, to guarantee the purity of certified seeds even the industry specifies considerably larger separation distances. Thus, for contract growers of certified hybrid seeds, such as hybrid corn, distances of 400 m or more are demanded. In contrast, the biotechnology industry proposes to release GE crops into the environment without adequate biological controls to prevent their dispersal or the artificial transgenes they express. According to their proposals, the strict safety guidelines that apply to GE organisms in the laboratory are not deemed to be necessary when these are grown in open fields, but without scientifically justifying this double standard in safety conduct. One might consider that even more stringent safety controls should be enforced in the natural environment than in the laboratory, particularly as we do not have a backup with products of this irreversible technology. Moreover, there is already sufficient evidence to show that engineered artificial gene constructs may undergo mutation and evolution to an end that we are not aware of, and therefore making the safety assessment of GE crops an exercise without a firm predictive scientific basis. Indeed, one cannot safety assess something that has not yet evolved. Genetic contamination In the absence of adequate methods to remove inserted transgenes, once the seeds are genetically contaminated, it will be nearly impossible to recover the original uncontaminated seed stock. Under the regulatory systems of most countries, testing of seeds for genetic contamination is done after the event and not before. In the USA and Canada the whole seed system has become contaminated after ten years of large-scale commercialisation of GE crops. Thus, even though only about one percent of the corn seeds sown in Iowa (USA) was StarLink, in the absence of adequate separation between the GE and non-GE cornfields and segregation of the seeds after harvest, about 50 percent of the corn produced contained the StarLink transgene, demonstrating that coexistence of GE and non-GE crops is impossible. The proposal by the MS Swaminathan Task Force that regions in India representing either primary or secondary centres of genetic diversity for major crops such as rice should be conserved for posterity as "agro-biodiversity sanctuaries" and "organic farming zones", is manifestly impractical and will not stop the genetic contamination of rice crops in other areas. In a democracy once the floodgates are opened it is impossible to control who grows what. It also means that other parts of the country will be opened up for GE crops. This therefore is nothing but a back door entry to introduce them by a slight of hand which, on the face of it, appears to give false assurances to people that there is no threat at all that genetic contamination will spread in the country. Risks of GEOs In order to satisfy the legitimate demands of the scientific community and society any large-scale growing of GE crops and their coexistence with crops grown using traditional and organic agricultural practices must be based on or at least take into account the scientific guidelines as laid out very recently in the authoritative ESA (Ecological Society of America) Report on the possible risks of GEOs (genetically engineered organisms) because these may create new, and more vigorous pests and pathogens; exacerbate the effects of existing pests through hybridisation with related transgenic organisms; harm non-target species of organisms; disrupt biotic communities, including agro- ecosystems; cause irreparable loss or changes in species diversity or genetic diversity. Therefore GEOs require greater scrutiny than crops produced by traditional breeding We shall also have to consider that GEOs may pose risks to the environment because we have little or no prior experience with the trait and host combination; GEOs may proliferate and persist without human intervention; genetic exchange is possible between a transformed organism and non-domesticated organisms; trait confers an advantage to the GEO over native species in a given environment. If these principles are not taken into account in proposed legislations, the large-scale growing of GE crops can irreversibly harm our environment by genetic contamination of our traditional crops and weeds by cross-fertilization and by horizontal gene transfer respectively. Moreover, in the absence of science-based regulation of the cultivation of pesticide-producing (i.e. Bt-toxin) GE crops, the development of resistance in pests to biopesticides which are also used in organic or traditional agriculture will be speeded up. The uncontrolled large-scale cultivation of herbicide-resistant GE crops will not only contaminate our environment but also lead to the creation of herbicide-resistent superweeds and thus increase rather than reduce the chemical-load of the land and endanger our clean water supply. Transparency It is therefore not unreasonable to suggest that the environmental and health risks or safety assessments of GE crops/foods should not be carried out only by biotechnology companies but it must also be verified by independent scientists through a transparent funding system. Any controlling legislation must also be based on these assessments and debated by all stakeholders in the society. The basic rule must be that, since we all want to live in a healthy and natural environment and eat foods which will not endanger our health, we are all entitled to scrutinise the evidence relating to the safety of GE crops. Secrecy is therefore against the public interest and unjustified. GE technology is irreversible and therefore we have to seriously weigh up the pros and cons of its introduction. In democracies it is the people's inalienable right that they should be able to decide whether society can afford to take on the very real risks and the possibly dangerous consequences of genetic engineering for the possibly vain hope of some future benefits for society. GM Food Labels Should Not Be Misleading Kirit S Javali advocates@jafajavali.com Law Offices of Jafa & Javali is a full fledged Corporate law firm with niche expertise in IPR & Biotech law, with offices in New Delhi, Bangalore and Mumbai. The debate over foods derived from GM crops often touches on the subject of labeling. Ideally a label should not prejudice the consumer for or against the product. Labeling of genetically modified food and processed food using GMOs is an equally important issue with respect to food safety. With food laws being re-written by the Government of India, the proposal to enact a Food Safety and Standards Bill, 2005 (draft Bill is under circulation for comments) which will repeal a number of the existing food laws and take out food safety from another eight Central and state laws, assumes significance. The Ministry of Food Processing must be complimented for bringing out a comprehensive legislation that brings food manufacturing, its sale, and safety under a single umbrella. The proposed Bill also provides for setting up of a National Food Safety and Standards Authority, as well as provisions for setting up a Food Appellate Tribunals at the Central and state levels, and a number of scientific panels and committees. The Bill is however, silent on the issue of labeling of food products whether these are genetically modified or not. The Bill defines genetically engineered or modified food to mean food and food ingredients composed of or containing genetically modified or engineered organisms obtained through modern biotechnology. The debate over foods derived from genetically modified (GM) crops often touches on the subject of labeling. Under the said Bill there is no specific reference to labeling of genetically modified food. It provides for a general definition whereby all food items should contain a label. Many consumers argue and insist on their right to choose. As a result, many governments across countries have begun to heed these suggestions and have either implemented labeling regulations or are working on them. Unfortunately, while the question seem simple, the issue is not, especially if the starting point of labeling includes the process rather than the final product. Issues such as safety, cost, truth in advertising, choice, fairness, science, trade-barriers, regulatory responsibility, accountability, legal liability, among others are involved. Labeling policies Before any labeling rules can be implemented, governments would have to set up standards and services to conduct testing of the presence of GM ingredients; certification; and ensure that the quality standards are clear and achievable. While it is easy to detect GM ingredients in products where the GM ingredient is the main ingredient (like tofu or popcorn), it would not be so easy to detect them in processed products like oils, sugars and starches, which no longer contain any novel DNA or proteins. On another note, much of the food that is bought and consumed in developing countries is not packaged and consequently not labeled. Examples are soybean milk from a street vendor or fresh fruits and vegetables from the market. Another issue that regulators have to grapple with is the wording: ideally a label should not prejudice the consumer for or against the product. There is also the issue of whether the label would be useful or educational. To a homemaker who has heard little about the debate on GM food, a label that reads, "Made from genetically modified soybean" or "Grown from seed obtained through modern plant biotechnology" may create more confusion. International Approaches to Labeling Codex: The Codex Alimentarius Commission implements the joint FAO-WHO food standards program, the purpose of which is to protect the health of consumers and to ensure fair practices in the food trade. In view of this, it is pertinent to follow its rules and regulations in matters of food safety and labeling. The decisions made by Codex have profound effects on economics and health and well-being of citizens around the world. The fact that 165 nations are members of Codex and this membership represents 98 percent of the world's population, further illustrates the great influence Codex has. USA: The US has based their position on the doctrine of 'substantial equivalence', where labeling would be necessary only if the food was not substantially equivalent to a conventional food based on composition, nutritional differences, toxicity and new factors like allergens and intended use. European Union/ UK: The EU, (The UK, France, Austria, Denmark, Holland, Germany, Belgium, Finland, and Spain) position suggests a middle path, opposed to the US doctrine of substantial equivalence. It favored safety evaluation prior to market entry and mandatory labeling where the food can have an impact on health like the presence of allergens and substances not present in conventional foods. Labeling Regulations in India In some respects the existing Prevention of Food Adulteration Laws are more stringent as compared to Codex standards e.g., vegetables oils, butter and fats, permitted additives and food with special dietary uses. Some of the laws for different types of products also come under prevention of Food Adulteration Act, 1954 & Rules 1955. However, some are voluntary and prepared by the Bureau of Indian Standards. Some of them are as follows: Agmark (Agricultural Marketing) â€¢ Agmark products are free from adulteration and conform to the scientifically laid down principles of purity. It ensures consumer protection. â€¢ Each batch of Agmark products is pre-tested for quality in well-equipped lab by quality control and specially trained chemist. Fruit Products Order, 1955 â€¢ It includes sanitary requirements of a factory manufacturing fruit products, specifications for the processing of various types of fruits, sauces, vinegar, pickles, sun-dried and dehydrated vegetables, onions etc. Rules have also been laid down on limits of poisonous metals in fruit products, permissible harmless food colors. Preservatives and food additives. ISI Mark by BIS â€¢ This is also voluntary. Any manufacturer can adopt it to ensure safety of the product. Labeling Provisions In the larger interest of our country, with the burden of feeding an ever-growing population, it is quite possible that genetically modified crops and food with their potential benefits will enter the market in a big way. A reliable system of labeling demands an equally reliable system of monitoring ingredients through the production chain. Labels should tell consumers how and why these foods have been modified. The choice should be left to consumers who should make a choice on the basis of his/ her perception. Verifiable Labeling The proposed Food Bill should consider the aspect of labeling in terms of the future when GM food may actually be permitted by the government. The only way to develop and maintain a labeling system that is truthful, not misleading, and verifiable is to ensure it is based on objective criteria, such as the actual composition of the food, and not on the method of manufacture. ]]> <![CDATA[SEC advisory panel favors Sarbanes-Oxley reforms]]> https://biospectrumindia.com/news/95/1450/sec-advisory-panel-favors-sarbanes-oxley-reforms.html https://biospectrumindia.com/news/95/1450/sec-advisory-panel-favors-sarbanes-oxley-reforms.html Fri, 06 Jan 2006 09:54:00 +0530 SEC advisory panel favors Sarbanes SEC advisory panel favors Sarbanes-Oxley reforms The Securities and Exchange Commission's (SEC) Advisory Committee on Smaller Public Companies has voted overwhelmingly in favor of reforming Section 404 (internal controls) of the Sarbanes-Oxley Act of 2002. "This is an indication that the committee understands the financial burden that Section 404 of Sarbanes-Oxley places on small public companies. We are not recommending a legislative change to Sarbanes-Oxley, instead we are asking the SEC to ease sections that are creating harmful, unintended consequences for small public companies," said Jim Greenwood, president and CEO of the Biotechnology Industry Organization (BIO). The SEC formed the 21-member advisory committee to consider ways of improving the impact of Sarbanes-Oxley on small public companies. Sarbanes-Oxley, the corporate governance law, requires publicly traded companies to adhere to standards that broaden board members' roles in overseeing financial transactions and auditing procedures. The committee's recommendation will be released for public comment prior to its meeting on January 23, 2006. The final recommendations are due in April. BIO has formed a coalition of biotechnology, healthcare technology, high technology and venture capital industries to seek reform to Section 404. Coalition members argued that complying with the Sarbanes-Oxley external auditor requirement can cost upwards of $1 million, often doubling a small firm's operating costs. The coalition recently sent a letter to the SEC advisory committee recommending that smaller public companies be: defined as the bottom 6 percent (based on a quarterly average) of the total US public market capitalization or by a revenue threshold set by the average revenues of companies at the bottom 6 percent of total market capitalization; exempt from having external auditors attest to internal controls. This would not exempt small public companies from complying with Sarbanes-Oxley as a whole; allowed to take a risk-based approach to prioritizing their key financial controls and to alternate the frequency of control testing to every second or third year. Source: www.bio.org Benefits drive demand for biotech crops in the US As a result of increasing benefits from biotechnology-derived (biotech) crop varieties, farmers are adopting the technology with greater ease than ever before, according to a new study update released by the National Center of Food and Agricultural Policy (NCFAP). In 2004, farmers in the US planted biotech crops on 118 million acres, an increase of 11 percent over the previous year. Compared to conventional crops, biotech varieties increased food production by 6.6 billion pounds, a 24 percent improvement from 2003, and provided $2.3 billion in additional net returns for the US growers, a 21 percent increase from the previous year. Biotech crops also reduced pesticide use by an additional 34 percent, or 15.6 million pounds. Pesticide use dropped by 15.6 million from 2003 to 2004. The study examined 11 case studies of six biotech crops planted in the United States in 2004 - corn, soybean, cotton, papaya, canola and squash - and is based on data from the US Department of Agriculture's National Agricultural Statistics Service and surveys of Crop Specialists from various universities. According to the study, insect-resistant crops again produced the greatest yield increase among the crops studied, improving food and fiber production by 6.5 billion pounds. While insect-resistant traits increased production, herbicide-resistant varieties generated the greatest reduction in production costs. Herbicide-resistant varieties cut costs by $1.8 billion and reduced pesticide use by 55.5 million pounds. Source: www.ncfap.org Singapore accepts guidelines on genetic research The government of Singapore has accepted ethical guidelines that spell out the limits of genetic testing and research. The Bioethics Advisory Committee (BAC) had recently announced the publication of its recommendations for genetic testing and research. In its report entitled "Genetic Testing and Genetic Research", the BAC sets out considerations for the ethical use of genetic testing in the detection of specific heritable genetic conditions and susceptibilities, as well as the genetic information thereby derived. In addition, the BAC also provides ethical guidance on the conduct of human genetic research in general. Researchers who run foul of the guidelines can be stripped of their funding, be suspended from practice and even fined, depending on the severity of the breach. This report is the culmination of an extensive research, which began in October 2003, and a public consultation process. Source: www.biomed-singapore.com USA, Singapore to work together on emerging diseases The governments of the US and Singapore signed an historic agreement renewing their joint commitment to work together to prevent and respond to pandemic influenza and other emerging diseases in Southeast Asia. The document provides for the operation of the Regional Emerging Diseases Intervention (REDI) Centre, and follows an earlier Memorandum of Understanding between the Singapore Ministry of Health and the US Department of Health and Human Services (HHS) pledging to cooperate on a range of health issues, in particular emerging infectious diseases such as Severe Acute Respiratory Syndrome (SARS) and avian influenza. The Redi Centre will be located at the Biopolis. Source: www.biomed-singapore.com EuropaBio hails initiatives of EMEA on biosimilars EuropaBio, the European Association for Bioindustries, has welcomed the initiative of the European Medicines Agency (EMEA), a decentralized body of the European Union with headquarters in London, to publicly debate and engage in a direct dialogue on the development and approval of similar biological medicinal products (biosimilars). The EMEA/DIA workshop has offered all stakeholders, including the industry, the opportunity to present comments on the recently released draft EMEA/CHMP guidelines on biosimilars. The EMEA is willing to finalise these guidelines in a transparent manner, which is most appreciated. In a release, EuropaBio said, "It appreciates EMEA's comments recognising that other stakeholders, such as physicians and patients should become more involved and informed about the issues around biosimilars." However, EuropaBio believes that there are still important issues to be discussed in a transparent manner in order to ensure that biosimilars will be used safely and effectively, including the need for a unique name and label for a biosimilar. Clear and distinct labelling is essential to avoid confusion between the innovator product and a biosimilar and to facilitate pharmacovigilance obligations. Dr Andrea Rappagliosi, chairman of the EuropaBio Healthcare Council and member of the Programme Committee of the EMEA/DIA joint workshop said, "EuropaBio is confident that this conference will allow the EMEA to finalise the sound and science based guidelines and we look forward to further discussions on the outstanding issues". EuropaBio therefore calls on the EU to further consider these important issues in the run-up to the issuance of the finalised guidelines, expected in the first semester of 2006, and before the approval of the first biosimilar medicines. Source: www.europabio.org World's first Biotech Code of Best Practice for Reporting launched in Australia To promote better communication between the life science industry and investors, Australia's biotechnology industry body, AusBiotech, and the Australian Stock Exchange (ASX) released the world's first Code of Best Practice for Reporting by Life Science Companies. The Code was officially launched by the Victorian Minister for Innovation, John Brumby in Melbourne. Life Science companies are not always fully understood by the market, making accurate assessment more difficult, because brokers and investors are simply not in a position to comprehend the science involved and lack awareness of the fundamental issues and events that drive value in these companies. The Code is designed to bridge this "information gap" by providing a disclosure framework that identifies the key drivers of value for life science companies and gives guidance to companies on the information investors need to make informed investment decisions. The release of the Code follows an extensive consultation phase involving key representatives of the life science sector and the investment community. A committee jointly formed by ASX and AusBiotech in December 2004 has reviewed the existing draft, in circulation since April 2004, in the light of submissions received from the industry and the investment community. The 17-member committee was chaired by Michael Hirshorn of Nanyang Ventures and consisted of senior representatives of listed companies, analysts, and other stakeholders. While the Code encourages best practice in reporting and is expected to be adopted widely, it is not mandatory. Existing disclosure obligations under ASX Listing Rules will be complemented by the Code to assist companies in meeting those obligations. Source: www.ausbiotech.org Continue reforms in favor of biotech companies, govt urged France Biotech, the French biotechnology industry association has urged the government to finalize the tax reform for innovative companies in order to confirm the national priority it has granted to biotechnology, research and innovation. On the right path with the Young Innovative Enterprise Status (JEI â€“ Jeune Entreprise Innovante), which has experienced resounding success with biotechnology firms, the reform of the Research Tax Credit along with various other measures in the sector, this reform will be truly achieved only by setting up a favorable environment for significant fund raising on stock markets and if the fiscal incentive cap is not detrimental to productive investments in the economy. Thus, FCPI (Fonds Communs de Placement dans l'Innovation â€“ Common Funds for Investment in Innovation) that invest 60 percent of its funds in innovative companies may drastically decrease since the new, low and uniform cap of â‚¬ 8000 on all fiscal incentives was introduced in the 2006 Finance Bill. This cap is totally inconsistent with an ambitious policy that would effectively be favorable to innovative businesses. This cap will lead taxpayers who often invest â‚¬ 10,000 to 25,000 in FCPI to now give priority to tax cuts linked to home improvement or to child minding! The stock exchange relay is also vital to the creation of French and European champions in the biotechnology and high technology sectors. The fourth edition of the annual biotechnology industry report points out at the national level the problems already observed in Europe: the lack of stock market relay paralyzes the chain of financing for innovative companies, and the gap between Europe and the United States has been growing. Significant efforts should rapidly be made so that the biotechnology industry can quickly reach its phase of maturity and hold its driving role in Europe and internationally. Source: www.france-biotech.org BIA hails govt stand on funding of stem cell research The BioIndustry Association (BIA) welcomed the announcement made by the Chancellor, Gordon Brown, and health secretary, Patricia Hewitt, that the government is to put in place measures to help make the UK a world-class environment for health research, development and innovation. These include more integration and coordination within the national health service, increased IT capability facilitating the recruitment of patients into clinical trials and collection of data, and reforms to improve performance and streamline regulatory procedures. Aisling Burnand, chief executive of the BIA, said, "The BIA warmly welcomes these steps which are designed to increase innovation and will ultimately result in new and improved medicines for patients." The government also announced its response to the UK Stem Cell Initiative (UKSCI) report and recommendations, a panel chaired by Sir John Pattison. The government accepted the recommendations and committed to £100 million of funding over 2006 to 2008, an additional investment of £50 million. Commenting on the UKSCI recommendations, Dr Simon Best, BIA Board member said, "The BIA strongly welcomes the government's recognition of the national strategic importance of this new area of medicines, and the commitment of additional funds for stem cell research. The BIA believes that the existing stem cell networks in the UK should be used as a base from which to coordinate further national research in order to convert stem cell technology into new medical treatments for patients as quickly as possible. The BIA has been actively involved in dialogue on stem cell research since the introduction of the Human Fertilization and Embryology Act and welcomes further public dialogue on this subject." Source: www.bioindustry.org Israel passes Bill allowing generic R&D in patent period The Knesset (the house of representatives of the State of Israel) Constitution, Law and Justice Committee unanimously approved for its second and third readings an amendment to the Patents Law (1967) (amended 1998) to allow generic drug companies to prepare for the manufacture of generic alternatives to ethical drugs before the patents to the latter expire. As a counterweight, the Israel Patent Office will be authorized to grant five-year extensions of ethical drug patents. International pharmaceutical companies and Israeli generic drug makers reached agreement on limiting the list of countries that extend the patents for a given drug, which will be the basis for Israel extending the patent. Under the original wording, a patent holder may apply to extend a patent in Israel only after applying to do so in all 120 member states of the World Trade Organization (WTO), including countries with no interest in the drug. At the recommendation of Constitution, Law and Justice Committee chairman MK Michael Eitan (Likud), the number of countries was limited to 21, including the US, UK, some other European and Scandinavian states, and Australia. A key clause in the amendment is intended to prevent harm to Israel's interest not to lag in the distribution of generic alternatives, while also not affecting the import of the relevant ethical drug. Therefore, the patent extension granted in Israel will match the shortest among the extensions the patent holder obtained in other countries. Source: www.globes.co.il bioProcessUK estimates 30 new biopharmaceuticals by 2012 bioProcessUK, the UK's national bioprocessing network, estimates that up to 30 new biopharmaceuticals, products currently being developed by UK companies, using cell-based manufacturing techniques, could be approved over the next seven years. The estimated figure is based on the probability of approval for biopharmaceutical candidates currently in clinical trial phases I, II and III and pre-registration phase. Biopharmaceuticals, drugs based on large complex molecules produced in a living system in contrast to chemically synthesized pharmaceutical drugs, are a major advance in modern medicine. Biopharmaceuticals have the potential to transform the treatment of many serious diseases for which there is currently no safe or effective therapy. bioProcessUK's research has unveiled that there are over 50 UK companies involved in biopharmaceutical development, the transformation of a candidate drug into a biopharmaceutical product utilizing living cells as their manufacturing unit. The current pipeline of these companies is composed of 127 products in pre-clinical trials, 70 products in clinical trials and 4 products in pre-registration. The results also confirm that the UK is second in the world, behind the US, in the initial development of biopharmaceuticals. The research also involved an analysis of types of biopharmaceuticals in development, showing that proteins and protein antibodies make up two-thirds of the UK's pipeline. Other active substances in development include cells and nucleic acids. This promising pipeline is a driving force in the number of bioprocessing contract manufacture and supply companies based in the UK. These companies are involved in the scale-up and manufacture of biopharmaceuticals, which have been engineered by a bioprocessing development company. Source: www.bioindustry.org Tailor-made stem cells research under cloud A major controversy has erupted over the work of the Korean scientist Prof. Hwang Woo-Suk in the stem cell arena. In May 2005, Hwang's team announced in a paper published in Science that it had successfully cloned 11 different stem cells tailored to individual patients, paving the way for future development of therapies for hard-to-cure diseases. This was hailed as a revolutionary step in stem cell research and had brought Hwang instant adulation and fame, not only in South Korea but also in the entire world. However, since the past one-month serious doubts regarding the authenticity of his work have surfaced. An investigative panel of experts from the Seoul National University, where Hwang worked and also South Korea's top university said in an interim report that the laboratory data for 11 stem cell lines, which were reported in the 2005 paper, were all data made using two stem cell lines in total. To create fake DNA results purporting to show a match, Prof. Hwang's team split cells from one patient into two test tubes for the analysis, rather than actually match cloned cells to a patient's original cells, the university said. Meanwhile, a report supporting Hwang's claim appeared in South Korea's Yonhap news agency. It mentioned that the DNA fingerprints of some of five cloned embryonic cells from his laboratory matched those of original patient somatic cells, quoting an unidentified source. However, it is too soon for them to be considered legitimate stem cells as they are in an early stage of growth, the report said. At present, the Seoul National University has commissioned tests on more cell samples taken from Hwang's lab and the investigation panel at university has asked three outside labs to conduct the DNA tests to determine whether Hwang was ever able to develop a colony of stem cells from a cloned embryo. The panel plans to give a final report on the investigation in January. Amidst these allegations, Prof. Hwang maintains that he had produced the technology to create patient-matched stem cells as he claimed to do in a May article in the journal Science. In the aftermath of this controversy, he has resigned from Seoul National University. "There is no doubt that we produced 11 patient-specific stem cells, and possess the core technology to create them (again)," Hwang said during the televised press conference at Seoul National University (SNU) recently. However, the professor admitted six of the 11 cloned embryonic stem cells cultivated in his research were severely "contaminated" earlier this year and it was impossible to keep them alive. Hwang said his team is working on thawing the five remaining stem cells, which will take about 15 days to complete. "If the five stem cells match those of the donor, the entire controversy will be resolved," said Hwang.   ]]> <![CDATA[Demand for animal biologicals on the rise]]> https://biospectrumindia.com/news/95/2785/demand-for-animal-biologicals-on-the-rise.html https://biospectrumindia.com/news/95/2785/demand-for-animal-biologicals-on-the-rise.html Fri, 06 Jan 2006 09:50:00 +0530 Demand for animal biologicals on the rise Demand for animal biologicals on the rise Although India has been exporting animal biologicals, in some areas it is looking at imports to meet the growing demand. The potential is huge as the animal biologicals market is growing at the rate of 15 percent against animal healthcare market of seven percent. With government support, the private sector is keen on entering this space to bridge the gap between supply and demand. Only humans can benefit from medical biotechnology is a myth. Now even animals stand to benefit. As against another myth that animals are being exploited by applying biotechnology on them. Researchers and scientists are working to produce biotech products for the well-being of animals. And they have been successful in developing many animal biotech products. The health of all animals including companion, better known as pets, can be significantly improved through the use of biotech vaccines, such as the rabies vaccine, and new diagnostic tests that can identify things such as feline HIV. Domestic farm animals can greatly benefit from biotechnology through vaccines and diagnostic tests. Improved breeding programs enhanced by biotechnology can drastically improve herd health by eliminating hereditary diseases. Reproduction and breeding techniques influenced by biotechnology, such as in vitro fertilization, artificial insemination can even save endangered species by restoring shrinking populations. Government Initiatives â€¢ Animal wealth in India has increased manifold and animal husbandry practices have changed to a great extent following the introduction of newer technologies particularly for crossbreeding and upgradation of indigenous breeds. More recently, with the liberalization of trade after the advent of World Trade Organization's Sanitary And Phytosanitary (SPS) agreement, the chances of ingress of exotic diseases into the country have increased. For ensuring disease-free status and to be compatible with the standards laid down by the Office International des Epizooties (OIE) - World Animal Health Organization, major health schemes have been initiated to support animal health programs in the states. â€¢ Further, in order to control the economically important livestock diseases and to undertake the obligatory functions related to animal health in the country, the Central government is implementing a centrally sponsored macro-management scheme called "Livestock Health and Disease Control". The scheme is being implemented with an outlay of Rs 525 crore. The Scheme has several components - Assistance to States for Control of Animal Diseases (ASCAD), National Project on Rinderpest Eradication (NPRE), Foot and Mouth Disease Control Program (FMD-CP) and Professional Efficiency Development (PED). â€¢ During 2005-06, the department of animal husbandry, ministry of agriculture, allocated about Rs 99.95 crore for livestock health. The outlay includes Rs 55 crore for animal disease control, Rs 7 crore for National Project on Rinderpest Eradication, â€¢ Rs 2.95 crore for professional efficiency development and Rs 35 crore for Foot and Mouth Disease Control Program. â€¢ For control of major livestock and poultry diseases by way of prophylactic vaccination, the required quantity of vaccines are produced in the country at 26 veterinary vaccine production units. Of these, 19 are in the public sector and seven are in the private sector. Import of vaccines by private agencies is also permitted as and when required. According to the annual report 2004-05 of the department of animal husbandry, ministry of agriculture, a network of 26,540 polyclinics, hospitals and dispensaries and 25,433 veterinary aid centers, supported by about 250 disease diagnostic laboratories, are functioning in the states and union territories for quick and reliable diagnosis of diseases. â€¢ The Department of Biotechnology (DBT) has also been funding many projects on animal biotechnology. During 2004-05, the DBT renewed 25 ongoing projects and 12 completed projects were also reviewed for their achievements. Besides it looked into proposals for 31 new projects for financial support. There is also a proposal to set up an autonomous institution for animal biotechnology.   Biotechnology provides new tools for improving animal health and increasing livestock and poultry productivity. This technology helps in increasing production of milk and meat. As noted earlier, biotechnology has potential applications in the management of several animal diseases such as foot and mouth disease (FMD), classical swine fever and bovine spongiform encephalopathy. The most important biotechnology-based products consist of vaccines, particularly genetically engineered or DNA vaccines. The improvements in these areas come from the enhanced ability to detect, treat and prevent diseases and other problems. Additionally, feed from biotech crops are better designed to meet the dietary needs of different farm animals, improve feed efficiency and reduce waste. Just like other assisted reproduction techniques such as artificial insemination, embryo transfer and in vitro fertilization, cloning can also significantly improve animal breeding programs and decrease the occurrence of hereditary diseases and improve the health of animals. Biotech-based products to treat heartworm disease, arthritis, parasitic infections, allergies and heart disease as well as vaccines for rabies and feline HIV are used by veterinarians regularly. Companion animals benefit greatly from vaccines and diagnostic tests based on biotechnology. Gene therapy has also been used to help restore sight to blind dogs as well as for melanoma, canine lymphoma and bone cancer. Some biotech companies offer DNA sequencing of pure bred animals, such as dogs, for identification purposes. Gene therapy for diseases of pet animals is a fast developing area because many of the technologies used in clinical trials humans were developed in animals and many of the diseases of cats and dogs are similar to those in humans. Institutions Involved in Manufacturing A list of institutions involved in manufacturing vaccines and other biological products for use on cattle â€¢ Institute of Animal Health & Veterinary Biologicals, Biological Products Div, Calcutta Institute of Veterinary Biologicals, Lucknow â€¢ Indian Veterinary Research Institute (IVRI), Biologicals Products Div, Izatnagar â€¢ Institute of Veterinary Preventive Medicine, Ranipet â€¢ Regional Veterinary Biological Unit, Jaipur â€¢ Punjab Veterinary Vaccine Institute, Ludhiana â€¢ Orissa Biological Products Institute, Bhubaneswar â€¢ Institute of Veterinary Biological Products, Pune â€¢ Institute of Animal Health & Veterinary Biologicals, Mhow â€¢ Institute of Animal Health & Veterinary Biologicals, Thiruvananthapuram â€¢ Institute of Animal Health & Veterinary Biologicals, Bangalore â€¢ Anti-rabies Vaccine Laboratory, Jammu â€¢ Institute of Animal Health & Biological Products, Srinagar â€¢ Haryana Veterinary Vaccine Institute, Hisar â€¢ Animal Vaccine Institute, Gandhinagar â€¢ Institute of Animal Health & Production, Patna â€¢ Institute of Veterinary Biologicals, Guwahati â€¢ Veterinary Biologicals & Research Institute, Hyderabad â€¢ Poultry Viral Vaccine Production Unit, Samalkot Source: www.indiadairy.com     Transgenic technologies are used for improving milk production and the meat in farm animals as well as for creating models of human diseases. Transgenic animals are used for the production of proteins for human medical use. Biotechnology is applied to facilitate xenotransplantation from animals to humans. Genetic engineering is done in farm animals and nuclear transfer technology has become an important and preferred method for cloning animals. Market scenario According to reports, the worldwide sales of biotech-based products for use in animal health generated $2.8 billion in 2003 (out of a total market for animal health products of $18 billion). The share of biotechnology-based products and services in 2004 was $4.1 billion out of the total animal healthcare market of $21 billion. This is expected to grow to $5.1 billion by the year 2005 in a total animal healthcare market of $23 billion. Animal biotechnology market is projected to be worth $12.5 billion by the year 2010. According to USDA, there are different licensed biotech products available for animals. These products include veterinary vaccines, biologics and diagnostic kits. The animal health industry invests more than $400 million a year in research and development. According to KV Balasubramaniam, managing director, Indian Immunologicals Ltd, the global animal biological market is one sixth of the animal health market of $18 billion. And it is growing at 7 percent against the animal health market growth rate of 2 percent. In India, the animal healthcare market is Rs 1000 crore growing at the rate of 10 percent. The major segments include cattle (45 percent), poultry (40 percent), canine (6 percent), sheep (4 percent) and others (5 percent). The animal biological market in the country is one fifth of the health market (Rs 200 crore) but it is growing faster than the health market at 15 percent. Segments in animal biologicals include cattle 42 percent, poultry (45 percent), canine (7 percent), sheep (3 percent) and others (3 percent). There is relatively higher growth of vaccines in animal health market in India due to new initiatives undertaken by government for control of animal diseases, progressively more emphasis on prophylaxis. Strong domestic industry with technology capabilities and sound cost structure has supported the growth of animal biologicals market. Hence Balasubramaniam said, "We see more of exports (Rs 20 crore) with little of imports (Rs 10 crore)." However, Prof S Krishnaswamy, chairman and managing director, Animal Biotech (Bangalore) Ltd, said, "Typically there are not many biotech products in India for animal healthcare application. The total market for pharma products for animal health is about Rs 1000 crore as per the ORG report. But most of these are antibiotics, anti-bacterials, vitamins and minerals. A GMO product developed by Sumitomo - somatotrophin (Bovine Growth Hormone was introduced in India but there were no takers owing to high cost. Sharing similar views, Alok Gupta, country head, life sciences and biotechnology, YES Bank Ltd, said, "The animal health care market is about Rs 1000 crore with growth rate of 8-10 percent. Besides specialized companies like Intervet India, Fort Dodge, an animal health division of Wyeth, ABIC, Merial, Venkateshwar Hatcheries, Serum Institute, big pharma companies such as GlaxoSmithKline, Pfizer, Novartis, Zydus Cadila, Alembic, Intas, Wockhardt have presence in the animal health care market." Prof S Krishnaswamy further said, "The other sector in animal biotech market is vaccines that is primarily for poultry and foot and mouth vaccine for cattle. These are produced by companies in private sector and vaccines for large animals are mainly produced by government agencies. The size of the vaccine market is over Rs 400 crore. Venkateswara Group and Srini Biologicals dominate poultry vaccine market. They have a captive market. Other important vaccine manufacturers are Indovax located at Hissar that has collaboration with Vineland, USA." Rajiv Gandhi, managing director, Hester Pharmaceuticals Ltd, which is mainly into poultry vaccines but eager to enter animal biologicals space, said, "Licensed biotech products for animals would include vaccines, enzymes, and growth promoters. Vaccines for poultry, dogs, cattle are manufactured in India besides many which are imported." According to Gandhi, the Indian poultry vaccine market is about Rs 150 crore. Manufacturers of poultry vaccines include Hester Pharmaceuticals (market share 10 percent), Venkateswara Hatcheries (group company of Western Hatcheries - 50 percent) and Indovax (9â€“14 percent). Imported vaccines meet the rest. Intervet does imports from parent company, American Home Products and Zydus Sarabhai from ABIC, Israel. He said, "Except one or two types of poultry vaccines, all are locally manufactured." Sharing his views on animal healthcare market, Gandhi said, "The animal healthcare industry in India has been increasing. In 2000 it was about $200 million, $215 million in 2003, $230 million in 2004 and in 2005, it is estimated at $246 million. Quoting the latest report of CLFMA of India, an Association of Livestock Industry, Dr Ashish Mohapatra, general manager - sales, Intervet India said, "The animal healthcare market is Rs 1,350 crore. There are 250 companies in this space. The market is growing at 8-10 percent. Although biologics contribute about 15 percent (i.e. about Rs 200 crore) of the animal healthcare market, it is growing at the rate of 25 percent. The biologics market can be mainly classified into poultry vaccine, (63 percent), cattle (FMD vaccine - 24 percent) and vaccine for companion animals (13 percent). Poultry contributes Rs 128 crore, cattle sector (Rs 47 crore) and pet animals sector (Rs 25 crore). Besides the private sector, there are many organizations in co-operative or public sectors. These are running at no profitâ€“no loss basis. "However, Bharat Tandon, chairman, CLFMA of India said, "The Indian animal biological market is about Rs 400-500 crore. The major contribution is from the public and cooperative sectors. The public sector mainly consists of the government institutes as all the state governments have one or two veterinary institutes to manufacture the basic vaccines for large animals like sheep, goat and cattle. These institutes supply animal biologicals at very nominal price or free to farmers. Hence it is difficult to calculate the exact size of the animal biologicals market. Besides there are companies in private sector too. It accounts to about Rs 200 crore." "In large animals the leading names include Indian Immunologicals, Intervet, and BAIF group. In poultry space we have VH group, Hester Pharmaceuticals, Indovax, and in the companion sector, the leading names include Intervet, Serum Institute, GlaxoSmithKline, the Sarabhai. Most of the vaccines for pets are imported and supplied through distributors. The market is small compared to the other two segments. The market is picking up and growing at the rate of 10-12 percent," said Bharat Tandon. Besides vaccines, according to USDA, animal biotech products include bacterins and bacterial extracts, antibody products, vaccines with bacterins/bacterial extracts/toxoids, diagnostic products, antitoxins and bacterin-toxoids. Veterinary Biological Products No. of licensed veterinary biological products available globally include: â€¢ Vaccines (155) â€¢ Bacterins and bacterial extracts (106) â€¢ Antibody Products (19) â€¢ Vaccines with bacterins/bacterial extracts/toxoids (185) â€¢ Diagnostic products (86) â€¢ Antitoxins (8) â€¢ Bacterin-Toxoids (54) â€¢ Toxoids (11) â€¢ Miscellaneous (11) Source: www.aphis.usda.gov   Molecular diagnosis is another area that is assuming an important place in veterinary practice. Polymerase chain reaction and its modifications are considered to be important. Fluorescent in situ hybridization and enzyme-linked immunosorbent assays are also widely used. Newer biochip-based technologies and biosensors are also finding their way in veterinary diagnostics. "Other areas of 'biotech' products include feed enzymes and probiotics. Recent entrants in this space include Advanced Biochemicals and Lumis Biotech who are into feed enzymes. There are many formulators and leading among them is Bangalore-based Vetcare. Wockhardt, Dabur are also vet product formulators. Natural Remedies, Himalaya and a few others make botanicals, plant-based bioproducts but these are not biotech products. Future products should include hormones (GMO), DNA vaccines and transgenic products from animal sources, " said Prof. S Krishnaswamy. In India, we find more of fundamental/basic vaccines for poultry and large animals such as FMD Vaccine, Gumboro vaccine-IBD, new castle disease vaccine, mareks vaccine, rabies vaccine and canine multi component vaccine and not other biologicals including the diagnostic kits. Balasubramaniam of Indian Immunologicals said, "Therapeutic and diagnostic products are almost non-existent in India." Bharat Tandon, chairman, CLFMA of India, informed, "The market for diagnostic kits for animals in India has picked up but price is the main reason for the sluggish growth. Besides we don't have more experts to do the tests. However, a few professors at veterinary colleges and government doctors who do private practice, are doing the tests. Their number is also limited and restricted to a few regions like coastal Maharashtra, Gujarat and Andhra Pradesh." Brighter outlook There are about 30 companies in animal biologicals both in public and the private sector. However, only a handful of companies are exporting vaccines. Still in some areas, India has to look at imports to meet the demand. India has imported 445 kg of anti serum in 2004-05 and exported 71.9 kg in 2004-05. Similarly the country imported 1200 vials of insulin in 2004-05. In 2004-05, India imported vaccines to the tune of - 68,70,000 /700 (vials/unit/doses) and also exported 3,30,950 vials/unit/doses. (These figures are up to October 31, 2004). The opportunity is opening up further. The government has been making efforts to bridge the gap between supply and demand. Dr S B Tatavarthy, deputy commissioner, department of animal husbandry, government of Maharashtra said, "There is manifold increase in the demand for vaccines after the Indian government launched a nationwide vaccination program and FMD control program to make "disease-free zones". The government institutes cannot fulfil the growing demand. Government agencies are supplying vaccines free of cost to the farmers." Foot and Mouth Disease has been widespread in India, creating massive economic losses at all levels. Its existence in India is not only limiting beef export opportunities but also hitting the farmers hard as milk production in FMD infected animals is drastically reduced. So the government of India has earmarked FMD control as a top priority and has put in place livestock improvement programs. A FMD eradication program has been in place in the western part of the country, comprising mandatory vaccination of 40 million animals annually for a period of five years. Once completed, the region will be declared a "disease free zone". Eventually "disease free zones" will be extended to the entire country. Biologicals and Manufacturers Major animal biologicals available in India â€¢ FMD vaccine (cattle & sheep) â€¢ Gumboro vaccine-IBD (poultry) â€¢ New castle disease vaccine â€¢ Mareks vaccine â€¢ Rabies vaccine (cattle & canine) â€¢ Canine multi-component vaccine Leading players in animal biologicals in India include: â€¢ Fort Dodge â€¢ Hester Pharma â€¢ Indian Immunologicals Ltd â€¢ Intervet â€¢ Indovax â€¢ Ventri Biologicals â€¢ Zydus Cadila   To prevent economic losses due to FMD and to develop herd immunity in cloven-footed animals, FMD Control Program is being implemented in 54 specified districts of the country in the first phase with 100 percent central funding as cost of vaccine, maintenance of cold chain and other logistic support to undertake vaccination. The state governments are providing other infrastructure and manpower. Five rounds of vaccinations will be done during the tenth plan and the allocation for this is around Rs 200 crore. About 1500 lakh vaccinations will be carried during the five rounds of vaccination. About 270 lakh vaccinations have been carried out under this program during the first round in 2003-04 and about 550 lakh vaccinations are expected to be carried out in second and third round. International players' presence in India â€¢ Akzo Nobel (Intervet) â€¢ Fort Dodge (American Home Product) â€¢ ABIC (Zydus Cadila) â€¢ CEVAC (Ranbaxy) â€¢ Merial (Hester Pharma) â€¢ Factro (Stellan) â€¢ TAD (Indo Bio Care (IBC) "Given the fact the current players are unable to fulfil the existing demand, there is an opportunity for 2-3 players in the market. This sector is a highly technical venture in terms of people and regulatory compliance. High entry cost barriers deters other small time players to enter this segment," said Gandhi of Hester Pharmaceuticals. Elaborating further on the opportunity, Bharat Tandon said, "There is a gap in supply and demand for large animals mainly in FMD. Hence companies are looking at entering this space." However, he observed that the government agencies have an edge over private players in this space in terms of reach as they have a very good network to reach to the micro levels. Gandhi believes that the animal biotech market has a good future. Reasons being, India is an emerging market. Demand for all products is going up. It is the biggest milk producer in the world and the fifth largest egg producer in the world. The current market in all sectors is becoming more competitive globally. India with a vast land mass and a huge population, does provide a good market. Companies like Bharat Biotech, one of the leading names in human biologics, Brilliant Industries, mainly into pet vaccines, Venkateshwara Hatcheries and Hester Pharmaceuticals which is mainly into poultry vaccines are entering the large animal vaccine. Narayan Kulkarni   ]]> <![CDATA[The Award Winners]]> https://biospectrumindia.com/news/95/1927/the-award-winners.html https://biospectrumindia.com/news/95/1927/the-award-winners.html Wed, 07 Dec 2005 16:03:00 +0530 The Award Winners The Award Winners Dr MK Bhan Dr NK Ganguly Sudhir Pai J Q-Vac & Shantetra BioSpectrum Awards 2005 A s in the past two years, the third BioSpectrum Awards were selected by a distinguished panel comprising members with di verse backgrounds. As is the practice, Dr Cyrus S Poonawalla, chairman, Serum Institute of India, Pune, who was the Biotech Person of the Year in 2004 presided over the meeting, which was held at the office of Serum Institute of India in Pune on October 22, 2005. The panel consisted of members representing various stakeholders of the industry like biopharma, bioagri, bioservices, venture capitalists, academics and infrastructure provider segments. The panel members were: Prof. AS Kolaskar, Vice Chancellor, University of Pune, Pune; Dr KK Narayanan, Managing Director, Metahelix, Bangalore; Deepanwita Chattopadhyay, Chief Executive Officer, ICICI Knowledge Park, Hyderabad; Sarath Naru, Managing Director, APIDC-Venture Capital Ltd, Hyderabad; Shyam Malhotra, Editor-in-Chief, BioSpectrum, and other CyberMedia Publications, Gurgaon; and E Abraham Mathew, Chief Editor, BioSpectrum, Bangalore. Dr Aravinda Babu, head, operations, WellQuest, Mumbai could not attend the meeting but sent his selection to the jury members. The panel was constituted in September and all the members were circulated the list of nominations and the backgrounder of the nominees through e-mail for their perusal, before the panel meeting in Pune. The Panel's mandate was to discuss four regular categories of awards-Biotech Person of the Year, Life Time Achievement, Entrepreneur of the Year, and the Product of the Year-and explore the opportunity for Special Category Award. BioSpectrum Editor N Suresh, Senior Assistant Editor Ch. Srinivas Rao and Assistant Editor Narayan Kulkarni provided the research support to the Jury. The Jury Dr Cyrus S Poonawalla, Chairman, Serum Institute of India Sarath Naru, MD, APIDC-Venture Capital Ltd Dr KK Narayanan, MD, Metahelix E Abraham Mathew, Chief Editor, BioSpectrum Deepanwita Chattopadhyay, CEO, ICICI Knowledge Park Prof. AS Kolaskar, VC, University of Pune Shyam Malhotra, Editor-in-Chief, BioSpectrum Dr Aravinda Babu, head, operations, WellQuest The jury was unanimous in selecting Dr M K Bhan, secretary, Department of Biotechnology as the Biotech Person of the Year. "He is an extremely positive person. He addressed various sectors of biotechnology in the national biotechnology strategy report that shows his understanding of the subject," observed Deepanwita Chattopadhyay. "Besides being a great scientist, he has proved that he is also an able administrator. His initiatives are showing results. There is an increased thrust to promote biotech entrepreneurs," added Dr KK Narayanan. "Contributions are far more visible. He is very accessible to the industry," said Dr Cyrus S Poonawalla. Prof. AS Kolaskar complemented, "Interaction with the industry has improved a lot after he became secretary of Department of Biotechnology and he has been able to get a lot of attention for the industry." Sudhir Pai J, CEO and Managing Director, Lotus Labs was chosen as the Entrepreneur of the year award for his ability to bring results. "He has built a good base as a biotech entrepreneur," said Sarath Naru. And "The valuation for Lotus Labs has proved his skills and ability as an entrepreneur," said Deepanwita Chattopadhyay. "All the nominees meet most of the criteria like charisma, ability to raise funds, ability to attract talents, have good business plan, etc. We have to give weightage to results achieved too. In delivering results, Sudhir Pai has an upper hand over the others," noted last year's Entrepreneur of the Year, Dr KK Narayanan. "Although it was acquired, the higher valuation for Lotus Labs has brought the attention of the investor community towards the Indian clinical research organizations, a growing sector in biotechnology," noted Abraham Mathew. Dr NK Ganguly, director, ICMR, was unanimously selected for the Life Time Achievement Award for his pathbreaking work in the past three-four decades, contribution to the evolution of biotech sector, and his visionary role. "Like Dr Bhan, he too is extremely open and has taken a lot of interest in building ICMR," noted Dr Cyrus S Poonawalla. "After he took charge of ICMR, Dr Ganguly brought energy to the institution. ICMR has many firsts to its credit under his leadership," said Prof. AS Kolaskar. The fourth Award to be discussed was the Product of Year. Dr Poonawalla requested Prof. Kolaskar to chair the jury for this award category and stepped out of the discussion chamber as his company's products too figured in the list of nominations. The quadravalent vaccines of Serum Institute of India and Shantha Biotechnics were jointly chosen as the Product of the Year. "Considering the quality and novelty of the product, its reach at an affordable price, the jury has jointly selected Q-Vac of Serum Institute of India and Shantetra of Shantha Biotechnics Ltd, both combination (quadravalent) vaccines for DPT and Hepatitis B for the Bioproduct of Year award," observed Prof. Kolaskar. During the deliberations, the jury decided against having any other special category awards this year. ]]> <![CDATA[Biotechnology will boost market for CO2 incubators in India]]> https://biospectrumindia.com/news/95/6963/biotechnology-will-boost-market-for-co2-incubators-in-india.html https://biospectrumindia.com/news/95/6963/biotechnology-will-boost-market-for-co2-incubators-in-india.html Wed, 07 Dec 2005 15:53:00 +0530 Biotechnology will boost market for CO2 incubators in India Biotechnology will boost market for CO2 incubators in India Although IVF labs are major users, the growth of the biotech industry will definitely open up the market for CO2 incubators in India. India has been involved in many basic research activities in the areas of cell biology, molecular biology, cancer, pharmaceuticals, life sciences and biotechnology. Scientists have made amazing strides during the past decade and in the recent years in the life sciences as well as biotechnology sectors. The technology used in these areas has had to keep pace with the changing needs of the researchers. The lab scenario has changed a lot over a period of time but the Carbon Dioxide (CO2) incubator continues to be a staple equipment in the research lab. CO2 incubators are one of the common equipment found in the laboratory. These are used for tissue and cell culture applications. These incubators work to control three essential variables related to replicating the mammalian environment; stable CO2 level, temperature, and relative humidity (RH). CO2 incubators allow these elements to work together to create an ambient environment for cells to thrive. The result is a balanced controlled pH, stable temperature, high relative humidity and controlled CO2 level. Although the ultimate goal of maintaining cell culture stocks has not changed, the functioning and operation of CO2 incubators has become more accurate, more reliable and more convenient. CO2 incubators are designed based on the needs of the researchers. The incubator meets absolute requirements in terms of constant and reproducible environmental conditions for tissue and cell culture applications. The CO2 cell is an ideal addition to the clinical, pharmaceutical, and biotechnology laboratory. Prominent players Thermo Electron Corporation is one of the leading names in this space with a market share of over 50 percent in India. This is after Thermo's recent acquisition of Kendro's range of products. Thermo has four brands in this space namely Forma, Jouan/ Napco, Revco and Heraeus. The other players include NuAire, Sanyo Biomedical, R S Biotech, Sheldon, Memmert, New Brunswick Scientific, Fischer Scientific and Binder. Most of these multinational companies have presence in India through distributors/dealers like Care Biomedicals SM Bioscience, Medi Spec Instruments India and JH Bio Innovations. According to Bimal A Desai, manager - marketing and sales, Thermo Electron LLS India Pvt Ltd, IVF (In Vitro Fertilization) labs and hospitals are major users of CO2 incubators. CO2 Incubator Applications Cell and Tissue Culture Immunology Genetic Engineering Protein Synthesis Virology Neurology Pharmacology In vitro Fertilization Human Vaccines Veterinary Vaccines Carcinogenicity Testing Monoclonal Antibodies Source: www.shellab.com Besides the pharma and biotechnology organizations, contract research organizations (CROs) are the other key users of these products in India. About 1000 units a year, priced in the range of Rs 1.5â€“4 lakh per unit are sold in the country. "Definitely with the growth of the CRO sector and the biotechnology industry, the market for CO2 incubators will grow at the rate of over 20 percent," Desai said. He further noted that although Thermo's products are highly priced, there are companies which prefer Thermo's range of brands mainly due to its features, proven track record and technologies. Despite its direct presence in India, Thermo also has indirect presence through its distributors and dealers to market the different brands of CO2 incubators. Sharing his views, Vippul Chhatbar, director, Medi Spec Instruments India Ltd, which is representing Lishen Scientific Equipments and Biotek in this space, said, "Thermo is a leader in this market with the acquisition of Kendro's range of products. The market for CO2 incubators is growing at over 25 percent." However, he said, about 300-350 units a year, priced in the range of Rs 2â€“2.5 lakh per unit are sold in the Indian market. Hari Kumar, managing director, JH Bio Innovations Pvt Ltd, said, "I feel there will be about 10-12 brands of CO2 incubators available in India. The total market size is 400-500 units a year and at the rate of Rs 2.5lakh per unit, it translates to Rs 10-12.5 crore size of the Indian market. The Indian market for this type of laboratory equipment is 3-4 percent of the world market and is growing at 35-40 percent against the world market growth of 15-17 percent [Main growth is from BRIC (Brazil, Russia, India and China) countries]. Looking at the present scenario in pharmaceuticals and life sciences industry, there will be a good demand for these products." Regarding the manufacturing CO2 incubators in India, he said laboratory instrument manufacturing is spread among 300-400 small and medium sized manufacturers and fabricators in India. "We have not yet witnessed any serious players trying to go for high volume and high quality manufacturing of these like in the US, Europe, Japan and some of the South East Asian countries. The limitation for manufacturing CO2 incubators is just the technologies, " said Hari Kumar. Since India is emerging as a clinical hub and manufacturing hub for vaccines, the market for CO2 incubators will pick up and expected to grow at over 25 percent. ]]> <![CDATA[Randox offers RX imola]]> https://biospectrumindia.com/news/95/5407/randox-offers-rx-imola.html https://biospectrumindia.com/news/95/5407/randox-offers-rx-imola.html Wed, 07 Dec 2005 15:50:00 +0530 Randox offers RX imola Randox offers RX imola Randox Laboratories has introduced an automated random access clinical analyzer called RX imola. This fully automated analyzer offers a host of features usually only seen on larger systems. The RX imola has the capacity to perform up to 400 tests per hour plus ISEs, and offers primary tube sampling, on-board sample dilution and a cooled reagent compartment. The other key features of the analyzer include comprehensive test panel for clinical chemistry, proteins and TDMs, cuvette wash system, refrigerated sample carousel for on-board calibrators and QC material, STAT facility, direct interface with hose computer, automatic re-run and pre-dilution functions. The RX imola uses dedicated software for easy access to all system facilities and functions. A full color, graphic user interface offers a clear and concise guide through the operating functions and provides a comprehensive data management system. For more details, contact: sreeram.gopal@randox.com Bio-Tek introduces Bio-Stack range of products Bio-Tek Instruments has expanded its line of automation solutions with two new Bio-Stack products. Joining the successful Bio-Stack Microplate Stacker, the new Bio- Stack Microplate Storage System can be used to store and feed microplates to any third party instrumentation equipped with a microplate gripper. User-configurable stacks allow the system to be used as a presenter and/or receiver with optimal flexibility. The new Bio-Stack Twister II Microplate Handler can be interfaced to one or more Bio-Tek readers, washers and liquid handling systems, adding incremental storage capabilities and automation for entire work cells. As a scalable robotic arm capable of handling up to 320 microplates, the handler improves efficiency and frees up valuable research time. For more details, contact: vippul@miil.in Thermo launches protein analyzer system Thermo Electron Corporation has launched its new complete instrumentation package for the analysis of proteins, the Proteus protein analyzer system. The system is based on Fourier transform infrared (FT-IR) technology and uses a Nicolet series FT-IR spectrometer to non-destructively scan protein samples for structural defect and impurity analysis as well as process quality monitoring. The instrument is principally designed for QA/QC and basic research in pharmaceutical research organizations. The Proteus protein analyzer is available as a complete system or as a kit for existing Nicolet 4700, 5700, 6700 or 8700 FT-IR spectrometers. Thermo's Proteus protein analyzer achieves quality infrared protein measurements within minutes. It combines quality instrumentation with proven methodology to provide a single source for critical data including identifying and classifying types of proteins, analysis of changes in protein over varying treatment conditions, protein monitoring during synthesis, measurements of impurities present in protein solutions, and determination of protein secondary structure. For details, contact: chittur.seshadri@thermo.com Biotron Healthcare launches ADP Quest Assay Biotron Healthcare has introduced ADP Quest Assay of DiscoverX, USA. ADP Quest assay is a tool for researchers for profiling enzyme activity of kinases and ATPases. The assay employs a generic, non-antibody based, non-radioactive method to detect the amount of ADP produced as a result of enzyme activity. The amount of ADP produced is directly proportional to enzyme phoshphotransferase activity and is measured as a robust red-shifted fluorescence emission signal. The tool is used to determine Michaelis-Menten kinetics and to profile inhibitor mode of action and potencies. The assay is for research use only and has been validated in 96-well and 384-well microplate formats. Some of the features and benefits of Assay includes Generic non-antibody based solutions for all kinases (includes low activity assays), Kinetic and Endpoint Capability. For details, contact: venkatesh@biotronhealthcare.com Eppendorf introduces range of microcentrifuges Eppendorf has introduced three new microcentrifuges - Centrifuge 5418, the Centrifuge 5424 and the Centrifuge 5430. Designed to reduce operational noises, maximize potential operational speeds and offer intuitive operational panels, these centrifuges have set new standards. The compact Centrifuge 5418 has a capacity for 18 x 1.5/2.0 ml tubes and it can achieve a maximum rcf of 16,873 x g/14,000 rpm. The 5418 centrifuge is perfect for customers that demand a high quality centrifuge for processing a reduced amount of samples. The advanced Centrifuge 5424 for extended applicational use, accommodates 24 x 1.5/2.0 ml tubes and achieves a maximum rcf of 20,238 x g/14,680 rpm. The Centrifuge 5424 can be equipped with up to four different rotors: an aerosol tight standard 24 place rotor, a PCR strip rotor, a specially designed KIT rotor for processing spin columns and a special coated rotor for ultimate chemical resistance. Operation of the 5424 with or without a rotor lid has been made possible without having to sacrifice operational silence. For more details, contact: info@eppendorf.co.in Cambrex launches Clonetics cell system Cambrex Bio Science Walkersville, a subsidiary of Cambrex Corporation launched Clonetics Human Lymphatic Microvascular Endothelial Cell Systems, the only pure and optimized lymphatic microvascular endothelial cells available for use in bioresearch. Cambrex is able to isolate populations of lymphatic microvascular endothelial cells with a guaranteed purity of greater than 95 percent and provide optimized media and supplements to ensure superior growth and performance in culture. These new cells join Cambrex's comprehensive offering of differentiated and progenitor cell types. Lymphatic endothelial cells play a key role in immune response by processing and delivering interstitial fluid to dendritic cells in the lymph nodes. The cells form capillaries that maintain fluid homeostasis in tissues by absorbing proteins and macromolecules and returning them to the blood for circulation. For details, contact: vivek.varma@cambrexindia.com Millipore's SureVent membrane offerings Millipore has announced the gamma stability of its SureVent hydrophobic and super-hydrophobic membranes for improved sanitization capabilities. The membranes are suitable for a broad range of liquid barrier and gas vent applications, including bag and tubing vents, vial vents, transducer protection, vent caps, insufflation, and gas monitoring anesthesia. Used within medical devices, the SureVent polyvinylidene fluoride (PVDF) and ultrahigh molecular weight polyethylene (UPE) membranes provide an economical alternative to traditional ethylene oxide sanitization treatments. Stabilized for exposure to gamma irradiation, the membranes maintain their physical properties after gamma sterilization. As a result, sterile packaging processes are replaced with a single radiation step to deliver enhanced productivity. A super-hydrophobic membrane, SureVent PVDF membrane repels most liquids, including alcohol, protein, lipid, and other solutions with low surface tensions. For more information, visit www.millipore.com/surevent TFF products from Millipore Millipore Corporation has announced two tangential flow filtration (TFF) products that allow researchers to easily and efficiently purify large volumes of protein-containing solutions. Applications typically include concentrating and desalting proteins from cell culture supernatants and fermentation broths. The high flux, low binding Millipore membranes used in these devices provide high protein retention and recovery. Pellicon XL Devices are available with a choice of either Durapore PVDF membrane (microporous), Ultracel regenerated cellulose membrane (ultrafiltration) or Biomax polyehtersulfone membrane (UF), and membranes for concentrating and desalting from 100 milliliters to 2 liters of protein-containing solution. Compared to large stirred cell systems, Pellicon XL Devices offer better flow rates with less processing time. Additionally, the devices can be "docked" with the Labscale TFF pump system from Millipore without the need for tubing or clamps. For more details, visit www.millipore.com/bioscience ]]> <![CDATA[Imperial Bio-medics signs pact with Matrix]]> https://biospectrumindia.com/news/95/1043/imperial-bio-medics-signs-pact-with-matrix.html https://biospectrumindia.com/news/95/1043/imperial-bio-medics-signs-pact-with-matrix.html Wed, 07 Dec 2005 15:45:00 +0530 Imperial Bio Imperial Bio-medics signs pact with Matrix Imperial Bio-medics, after establishing its mark in Real Time QPCR in the Indian market, is now expanding its activities and product development. Its focus is now to enter liquid handling equipment space. To achieve this, it has entered into a tie-up with Matrix Technologies for electronic pipettors, 2-D barcodes tubes and sophisticated automated pipetting systems. Matrix offers a wide selection of electronic pipettors that are faster and more efficient than manual products and a fraction of the cost of automation. It also provides any research lab with a oneâ€“stop opportunity to fulfil all of its liquid handling equipment and consumables needs. Matrix's range of products that will be introduced by Imperial include Hydra â€“ II line of micro dispenser, PlateMate Plus, Matrix WellMate, WellMate stacker and CellMate II. The Hydra â€“ II line of micro dispenser is the next generation liquid handling from Matrix, used as either a bench-top liquid handler or as an integrated microplate dispenser. PlateMate Plus has been designed with modular components - including interchangeable pipetting heads that support and facilitate prompt on-site service and deliver unparalleled flexibility, performance and value for a variety of microplate-based liquid handling applications. Matrix WellMate brings flexibility and cost-efficiency to microplate dispensing. It offers disposable, pre-sterilized tubing cartridges and rapid dispensing in a wide volume range (1µL to 2,000µL) and also accommodates any microplate-from six to 384 wells-or any height 96-position tube rack.   IBM joins hand with leading cancer centers IBM has joined hands with world's leading names in the cancer research like Memorial Sloan-Kettering Cancer Center (MSKCC), the Molecular Profiling Institute and the CHU Sainte-Justine Research Center - Mother and Child University Hospital Center under separate agreements to help to accelerate cancer research, diagnosis and treatment. Recognizing the critical role that information technology (IT) will play in the 21st century in understanding and treating complex and deadly diseases like cancer, IBM is working with the people, technologies and partnerships needed to battle this deadly disease. IBM and MSKCC are building a state-of-the-art integrated information management system to improve the ability of clinicians and researchers to study long-term cancer-related illnesses, identify disease trends and determine success rates. Funded by a $3 million grant of technology and services from IBM, MSKCC will include a comprehensive system to integrate its hospital data with text mining and related analytical capabilities into a unified information management environment to facilitate predictive analysis and research. In addition, pathologists at MSKCC are working closely with researchers at IBM to create a searchable database for pathology reports. IBM Healthcare and Life Sciences brings together IBM resources, including information technology, deep industry insights, and research expertise, to help clients develop and deliver safer, more affordable and more effective diagnostics, drugs and medical care. It is also teaming with the Molecular Profiling Institute and the CHU Sainte-Justine Research Center - Mother and Child University Hospital Center under separate agreements to accelerate cancer research, diagnosis and treatment.   IMS Health, SAS establish global partnership IMS Health, a provider of information solutions for the pharmaceutical and healthcare industries, and SAS, the leader in business intelligence, announced the launch of IMS Sales Force Effectiveness Precision Suite, a consulting offering that leverages the companies' world-class information, technology, analytics and industry expertise. This new offering helps pharmaceutical marketing and sales executives optimize their sales resources in markets around the world, enabling them to more effectively deliver essential product information to the right prescribers. IMS Sales Force Effectiveness Precision Suite combines three key capabilities â€“ precision segmentation, promotional response and resource optimization â€“ to help pharmaceutical decision makers develop and implement sales strategies uniquely tailored to their customers, products and markets. These capabilities are enabled through advanced analytics and data integration supported by key elements of the SAS 9 Enterprise Intelligence Platform. Available immediately, IMS Sales Force Effectiveness Precision Suite considers each client's unique environment and market events and integrates the full breadth of IMS information assets, methodologies and expertise with key client information. The result is a highly tailored and differentiated customer segmentation and sales strategy. Built on SAS' industry-leading enterprise business intelligence (BI) solution, the offering enables clients to work collaboratively to review and change market assumptions and model new outcomes to meet their evolving needs.   World Courier earns ISO certification World Courier has earned the ISO 9001 certification of five company-owned investigational drug storage/distribution facilities located in Buenos Aires (Argentina), Sao Paulo (Brazil), Santiago (Chile), Mexico City (Mexico) and Lima (Peru). Staffed by licensed pharmacists, these facilities provide comprehensive logistical solutions â€“ including storage, management and round-the-clock access to investigational drugs and supplies â€“ for pharmaceutical clients involved in global clinical trials in Latin America. The depots are administered by World Courier's Clinical Trial Supply Chain Services (CTSCS) division that opened in June 2004, making this the only company to operate a network of five GMP-certified pharmaceutical storage facilities in Latin America. The new World Courier facilities are fully GMP-validated, featuring four different temperature-controlled ranges for storage (15o-25 o C / 2 o-8 o C / -20 o C / -70 o C), with redundant automatic backup and emergency power systems. Inventories are electronically controlled using CTM-STAR, World Courier's own CFR21-11- compliant inventory monitoring system, and are visible by customers on a 24x7 basis via live Internet feed. Pall Corp presents approach for speeding vaccine production As avian flu concerns extend across the globe, governments and pharmaceutical manufacturers face potentially huge demand for vaccines. According to public health experts, current production capacity and response times would not suffice in the event of a pandemic. Viral vaccine development is governed by stringent regulatory controls and can take as long as eight to 12 years costing anywhere from $300 to $800 million. In a presentation at the 10th annual China International Pharmaceutical Industry Exhibition in Shanghai, Ian Sellick of Pall Corporation, described how the use of disposable and scalable technologies to purify large molecule vectors, such as for flu vaccines, can help manufacturers streamline the process and overcome many of the unique challenges associated with vaccine development. Sellick's presentation reviewed advanced approaches to purification as part of a total process management scheme to help vaccine manufacturers address issues of scalability, validation and process development. Disposable processing systems can be installed in practically every part of the vaccine development cycle from cell fermentation and harvesting to downstream processing steps. Disposables offer lower installation costs compared to stainless steel systems and eliminate cleaning and cleaning validation. These factors significantly lower labor and maintenance costs and reduce the time required for scale-up procedures. Disposables also reduce the risk of cross-batch contamination and of worker exposure to the biohazards inherent in vaccine development. Sellick also demonstrated the higher binding capacity of single-use Mustang membrane capsules for large molecule applications compared to conventional resin- or gel-based column chromatography. The process also incorporates the use of disposable prefilters, sterilizing grade capsules and final filters to provide exponential time, cost and labor savings.   LabVantage to increase its head count in India Considering the opportunity in India for Laboratory Information Management Solutions (LIMS) from biotechnology, life sciences and pharmaceutical industries, LabVantage Solutions is all set to expand its operations in India in terms of head count and looking at doubling its revenue. Speaking to mediapersons in Mumbai, James Aurelio, CEO world wide, LabVantage Solutions said, "India has been the main hub for our software development, solution implementation, client support and sales throughout the Asia Pacific region including India. With increasing requirements, we are augmenting our operations by reinforcing our team by hiring additional projects managers, business analysts and configuration experts. " He further said, "We want to become a center of excellence in India which combines our knowledge of global business and create opportunities to leverage the technical and domain knowledge resources in the life sciences area of the country. To achieve this we are strengthening our contribution in collaborating and offering specific solutions for diverse R&D institutions and companies in India." On asked about the revenue generated from the India operations, James Aurelio said, " It has doubled in the last two years. Asia Pacific region that includes India besides China, Taiwan, Singapore, Korea Thailand contributed about 9-10 percent of the total revenue. The major revenue comes from North America with 60 percent and remaining from Europe." At present LabVantage Solutions India has staff strength of 85 people offering solutions to variety of industries including process, pharmaceuticals and high-throughput informatics/ bioinformatics. TNT India acquires IIP Accreditation TNT India, a wholly owned subsidiary of TNT NV and which offers clinical express services, has been accredited with the Investors in People (IIP) standards, an internationally recognized accreditation for companies which can demonstrate that they have met and continue to meet a set of demanding standards in people's learning, development and management. IIP has been developed by the UK Government in partnership with representatives of UK employers organizations, employee bodies and professional institutions. Investors in People is an energizing business tool that stimulates and challenges organizations to make the best of their people by recognizing their contribution to the business. It provides performance improvement and ensures that skills and capabilities are maximized by offering a unique link between individual and organizational growth. An IIP Accreditation evaluates a company's HR process on its delivery success every two years. During the last audit, TNT India has been rated second in the Asian market. Headquartered in Bangalore, TNT India has 26 depots in 16 Indian cities and has over 600 employees and offers services that suit to different segments like life sciences, students and exporters. TNT is the only express distribution company to be awarded an ISO 9001:2000 certification for all its functions and branches across the country. Rockwell Automation to establish center in Singapore Rockwell Automation, a global provider of industrial automation power, control and information systems and services has said that it will establish an Asia-Pacific Business Center ("The Center") in Singapore, consisting of select business management, engineering, and manufacturing operations. The center will be fully operational by 2008. "This move reflects the next logical step in Rockwell Automation's growth strategy to invest in serving customers worldwide," said Keith D Nosbusch, chairman and CEO, Rockwell Automation. "It will also advance the company's goal to achieve an international revenue target of 50 percent by 2009," he added. The center will initially house several business segments that are in demand in Asia, and highly strategic to the company's global growth. They include: Small PLC Platforms, Distributed Input/Output, Component Operator Displays and Component Drives. Baxter confers award on Sartorius Sartorius AG, a global laboratory and process equipment provider, has received an award for its outstanding performance in optimizing a bioproduction process from the US pharmaceutical and medical device manufacturer Baxter. Sartorius, which provides Baxter with equipment and services in sterile filtration, won the "Outstanding Performance Award for Total Cost Management." Before that, Sartorius had designed, validated and implemented technologically and economically superior solutions for two Baxter process steps. "A tremendous success," commented Reinhard Vogt, senior vice president of sales and marketing of the biotechnology division at Sartorius. "Together with the customer, we developed the optimal solution for two processes while providing expert advice to Baxter concerning all aspects relevant to regulatory compliance and approval. This shows that our team offers not only strong individual technologies and products to biopharmaceutical customers, but also has the expertise to evaluate entire production lines and make them much more efficient." Seminar on environmental monitoring Easy Solutions, a Chennai-based company organized a seminar on "Environmental monitoring"- a fundamental process within the pharmaceutical/ biotechnology industry. It helps to indicate the levels of viable and non-viable contamination that can affect product quality. Morgan Polen, vice-president, Application Technology, Lighthouse Worldwide Solutions, USA, Tim Russell, director, Facility Monitoring Systems, the UK and Dr Volker-J. Friemert, director, Microbial Monitoring Systems, Biotest AG, Germany shared their views on different issues such as Particle Counting, Regulatory Monitoring Expectations, selection of monitoring locations and frequencies, continuous monitoring, selection of the right software for Facility Monitoring System, developing a user requirement specification, setting alert and action limits, Viable Microbial Sampling, ISO 14698 and Microbial sampling and compressed Gas Sampling. Ravi Murthy, president, Easy Solutions said "Through this program we wish to address the environmental monitoring for both sterile and non-sterile manufacturing and bring in awareness about the latest developments in the systems to the quality assurance and quality control professionals as well as production and engineering staff who require an understanding of these concepts." ]]> <![CDATA["Market for clinical trials in India has big potential "]]> https://biospectrumindia.com/news/95/2317/market-for-clinical-trials-in-india-has-big-potential-.html https://biospectrumindia.com/news/95/2317/market-for-clinical-trials-in-india-has-big-potential-.html Wed, 07 Dec 2005 15:42:00 +0530 New Page 1 "Market for clinical trials in India has big potential " Sanjiv Khaturia, director, sales and marketing, TNT India Private Limited. When did TNT start its clinical express services in India? We picked up the first blood sample may be six years ago in India but we really did not realize the market potential then. We used to operate this business from our Singapore office as it used to get the contracts and we used to just do the pick-ups. That is how it started. Only a couple of years back we realized the market potential and the need to expand our capabilities and resources to meet the requirements of the industry here. In the last two years we have done a lot of work and come a long way by developing capabilities in this space. Today we have improved our capabilities by understanding the local terrain and the regulatory issues in this space to cater to the needs of the customers. Our USP lies in packaging, coverage/good network of distributors (17 pick-up points across the country), contact with airlines and end-to-end service (import, re-distribution in India, pick-ups and export). What are the services you offer to life sciences/biotechnology companies? Globally we are into four areas as far as life sciences and pharmaceutical verticals are concerned. The first one is clinical trials - a happening area, and we transport samples like urine, blood and plasma. The second one is supplying diagnostic samples not directly linked to clinical trials. The third one is carrying medical equipment like pace makers. We also supply reagents necessary for these medical equipment. These are the four areas we are into. It is called the express industry where movement of material is time bound and time is a critical factor. The other part is movement of drugs and formulations. We also take up such services which come under a separate division called logistics. Of these these three areas â€“ diagnostics, clinical trials and medical equipment, which do you think has a potential for growth in India? Clinical trials is a big potential market at present. However, the diagnostic sector will grow and it is now getting organized. Companies like SRL Ranbaxy, Dr Lal's Labs and Metropolis are leading in the sector. But I personally believe that the diagnostics business is still fragmented and needs to be organized much more. In the area of clinical trials, India has a clear advantage of skilled, medical and scientific manpower, language, medical facility or genetic pool and is certainly well positioned in this space. We will definitely move ahead in this sector. I do not know the exact market in next five years for clinical research although different reports have different figures. I can only say that it will certainly be a large market and will grow. Do you have a dedicated team for clinical express services? We are a large business group. Therefore there are certain areas that are integrated and each division of the group will leverage on each other's network. However, we have a dedicated team of 25 persons focusing only on the operations and customer services of clinical express products. Other services such as pick-up and delivery is taken care of by other divisions also. What is the growth rate you are looking at for clinical express services in India? The percentage at present has no meaning. This is because we are starting from a small base compared to our total service. I can say we will grow by 400 percent this year in life sciences and that is mainly coming from clinical trials. We are investing in terms of resources such as manpower, training, infrastructure, more robust SOPs and in better packaging. We are getting ready for the upcoming market. How you see the competition in clinical express market in India? I see competition only from World Courier, which started offering its services in clinical trials quite earlier and from Marken. There are few others like DHL. But their presence is not felt much in the Indian market. But we are giving a tough fight to World Courier. Narayan Kulkarni ]]> <![CDATA[India making strides in crop genomics]]> https://biospectrumindia.com/news/95/2663/india-making-strides-in-crop-genomics.html https://biospectrumindia.com/news/95/2663/india-making-strides-in-crop-genomics.html Wed, 07 Dec 2005 15:40:00 +0530 India making strides in crop genomics India making strides in crop genomics Rice is the first food crop whose genome has been sequenced. Indian scientists were part of the international team, which sequenced the rice genome. In the August 2005 issue of the journal Nature, members of a 10-nation International Rice Genome Sequencing Project (IRGSP) reported a highly accurate and "finished" map-based DNA sequence of the entire rice genome. This marks one step forward in rice improvement and breeding high yielding varieties. This international project led by Japan was launched seven years ago. India, which has the maximum area in the world under rice cultivation (28 percent of its arable land) and produces about 130 million tons of rough rice every year, was a participant in the rice genome project. The Indian Initiative for Rice Genome Sequencing (IIRGS) was launched in June 2000 and was carried out at the University of Delhi, South Campus (UDSC), and the Indian Agricultural Research Institute (IARI) New Delhi with the support of the Department of Biotechnology and the Indian Council of Agricultural Research. The 28-member Indian initiative was jointly led by Dr Akhilesh K Tyagi of UDSC and Dr NK Singh of IARI and contributed to about 10 per cent of the global sequencing effort. Different chromosomes/region of chromosomes were assigned for sequencing to various countries and IIRGS was assigned to deliver about 14 Mb of nucleotide sequence, spanning a region from 57.3 cM to 116.2 cM on the long arm of chromosome 11 of rice. The mandate was not only performing high throughput sequencing but also annotation of data and gene discovery. To achieve this objective, at an estimated cost of Rs 48.83 crore (~ $10 million), two independent research facilities were established at the Department of Plant Molecular Biology in UDSC and National Research Centre on Plant Biotechnology in IARI. These labs were equipped with performing high throughput sequencing as well as detailed annotation of the generated data. By generating more than half a million individual sequences, Indian scientists assembled 16.5 million bases of the chromosome 11 coding for 2000 genes during the last five years thereby complementing efforts of more than 250 researchers from 10 participating nations. Besides Indian researchers, The $-200 million project also included researchers from Japan, USA, France, Taiwan, China, India, South Korea, Thailand, Brazil and the UK. Overall, the international consortium sequenced the 370 million base pairs of rice identifying the locations of over 35,000 genes that make the rice plant. Of the two most common rice varieties of the world, the team chose the 'Japonica' variety and now the Indian team plans to pitch in and complement the sequencing of the 'Indica' variety. The Indian government has already started a Rs 36-crore functional genomics project, which will help to identify/mine the useful genes. "India has a diverse germplasm and different ecological zones. This project has created a critical pool of trained scientists, infrastructure and capability to conduct genome wide research on a range of agronomically important crops", said Dr NK Singh, principal scientist and investigator, National Research Centre on Plant Biotechnology, IARI. Previously published draft sequences of rice are shown to lack the coverage and accuracy required to identify the important genes. The emerging information from IRGSP has already led to the identification of agronomically important traits, e.g. genes for "green revolution", disease resistance, genes influencing growth habit to promote yield and photoperiod sensitivity genes to extend the range of cultivations of elite cultivars of rice. This could help feed an expanding world population at a time when restraints on agriculture are increasing. In the Indian context, the completed rice genome sequence and the genes now identified will help extend the studies on related cereals like wheat, maize, sorghum, bajra and ragi. Tomato Genome Sequencing Initiative India is also a part of the "International Solanaceae Genome Project (SOL)". Researchers from more than 10 different countries kick-started this 10-year initiative in late 2003 in Washington DC. The long-term goal of the SOL program is to create a network of map based resources and information to address key questions in plant adaptation and diversification. Tomato is considered the model crop to study fruit ripening. Considering the importance of tomato it has been chosen by SOL as a model member of Solanaceae for sequencing of its genome and India has been allocated chromosome 5 for this project. The high degree of conservation in genome organization among Solanaceae members, would allow the information generated with tomato to be extended to other Solanaceae members in future. Since scientists are sequencing only the euchromatin part of tomato genome, it is estimated that chromosome 5 consists of approximately 11 Mb of euchromatin. However, researchers estimate that the actual sequencing effort may require 10 percent additional sequencing and 20 percent overlap between neighboring BAC clones. The sequencing of the chromosome 5 is being carried out at University of Delhi South Campus (5 Mb), National Research Centre on Plant Biotechnology, IARI (5 Mb) and National Centre for Plant Genome Research, JNU Campus (2 Mb). All these labs are producing a high quality sequence of the gene rich euchromatin region assigned to them; then the sequences will be processed and annotated followed by the identification of agronomically useful genes from tomato genome. The members of the Indian Initiative on Tomato Genome Sequencing have already confirmed 16 BAC clones from tomato chromosome 5 with the help of markers by PCR amplification, sequencing with marker-specific custom primers, end sequencing and fingerprinting. The shotgun libraries have been developed and high throughput sequencing has also started. India's foray in the functional genomics domain (in crops like rice, tomato and sugarcane) would help identify genes for improvement in relation to water use efficiency, disease resistance and yield. In tomato, it also includes increase in shelf life and better nutrition. The demonstration of the potential by India during the last five years will also pave the way for improved food availability and diversification of the agro industry. Rolly Dureha Plants have a double line of defense Plants are exposed to many different pathogens in the environment. Only a few of these pathogens, however, are able to attack a species of plant and "make it sick". If a particular pathogen is unable to attack a plant, that means that the plant is resistant to it - in other words, it cannot host the pathogen. This durable type of immunity of a plant to parasites is called nonhost resistance. Although, in nature, nonhost resistance stops almost all parasitic attacks, it has been the subject of little research. Now scientists from the Max Planck Institute for Plant Breeding Research in Cologne have uncovered the molecular components of nonhost resistance and described this system of defense in a recent edition of the journal Science. In their findings, they draw parallels between the immune systems of plants and animals. This research could be central to the development of new "green" fungicides. The Max Planck researchers were able to identify the gene known as PEN (penetration) as an important component of nonhost resistance. They isolated arabidopsis mutations, which are partially susceptible to powdery mildews. If these genes are defective, or if the protein they code is missing in the plant cells, the fungus can invade the leaf epidermis cells more frequently. For that reason the scientists looked particularly at the question of exactly which function the PEN2 protein has in the defense against pathogens. The researchers also observed that when PEN2 is missing, the plants become more susceptible not only to grass powdery mildew fungi but also other pests - for example, the pathogens causing late potato blight. PEN2 is therefore a basic component of the plant's immune system with a broad range of effects. However, if PEN2 is missing, the plant is not completely helpless against fungal diseases. There is still another line of defense, which they have to get through. If PEN2 is missing, the plant takes a drastic step: the cell dies together with its attacker, which protects the neighboring plant tissue from infection. In this deadly line of defense, very different proteins play a key role, which identify molecular traits only present in parasites by using immune receptors both on the cell surface and inside the cell. Only if this second mechanism also fails can the originally non-virulent grass powdery mildew fungus colonize the plant. The Max Planck research has demonstrated that the nonhost resistance of plants develops out of a defense system with at least two steps. These steps determine whether a plant is susceptible to a disease or not. The redundancy of the defense layers and the wide-ranging effects of PEN2 explain why, in nature, nonhost resistance is a durable and broadly effective defense mechanism. If a building block is missing from one defense layer, its function will be taken over by components of the next layer. In further studies, the researchers hope to try to identify materials that are built up via PEN2 at the place of infection. They surmise that these materials could lead to the development of new kinds of "green fungicide" with a broad range of effects in the fight against plant diseases. Loss of fear factor makes a timid mouse bold Researchers have identified a fear factor - a protein the brain uses to generate one of the most powerful emotions in humans and animals. The molecule is essential for triggering both the innate fears that animals are born with, as well as, fears that arise later in life due to individual experiences. Eliminating the gene that encodes this factor makes a fearful mouse courageous. The finding, the researchers say, suggests new approaches for drugs designed to treat conditions such as phobias, post-traumatic stress disorder and anxiety. Working on mice, the scientists led by Howard Hughes Medical Institute investigator Eric R Kandel at Columbia University, found that the protein stathmin is critical for both innate and learned fear. Mice without stathmin boldly explore environments where normal mice would be hesitant, and unlike their normal counterparts, fail to develop a fear of cues that have been associated with electric shock. The scientists also found physiological changes in the brains of mice lacking stathmin that correlate to the behavioral changes they observed. In their previous work, Kandel and his colleagues had determined the underlying mechanisms that encode fear in the brain. An indication that stathmin might contribute to fear came when they mapped the parts of the brain where the gene was most active. They found that stathmin was highly expressed not only in the amygdala, a region deep within the brain known to contribute to fear and other emotions, but also in other parts of the brain's fear circuitry. To investigate stathmin's role in more detail, the researchers created mice lacking that gene and examined the brain activity in the lateral nucleus of their amygdalas. Recent work from other labs had shown that during fear learning, the connections between the neurons in this part of the brain strengthen. In stathmin-deficient mice, however, the connections between these neurons remained virtually unchanged, despite repeated stimulation. From a series of such related experiments, Kandel and his colleagues concluded that stathmin is required for both innate and learned fear and as drug target presents a unique opportunity. Soy protein reduces effects of diabetes on liver A group of researchers from Mexico has discovered that a diet rich in soy protein may alleviate fatty liver, a disease which often accompanies diabetes. The high levels of insulin and insulin-resistance that accompany diabetes are often associated with fatty liver or hepatic steatosis, an untreatable condition that can lead to chronic liver disease and death. In this condition, large lipid-filled compartments accumulate in the cells of the liver due to an increase in production of fatty acids in the liver. The end result is an enlarged liver. Following up research that indicated that eating soy protein reduces lipid production and prevents hyperinsulinemia (the loss of effectiveness of insulin), Dr Nimbe Torres, of the Instituto Nacional de Ciencias Medicas y Nutricion in Mexico, investigated the effects of a diet high in soy protein on the development of fatty liver associated with diabetes. Dr Torres fed Zucker diabetic fatty rats that develop hyperinsulinemia and hepatic steatosis a diet of soy protein for 160 days. She found that the consumption of soy protein prevented the accumulation of triglycerides and cholesterol in the liver despite the development of obesity and hyperinsulinemia in the rats. The effects of soy protein were due to a low expression of genes involved in the synthesis of fatty acids and triglycerides in the liver and these changes were due to a reduction in the transcription factors that control the expression of genes involved in lipid production, explained Dr Torres. In addition, levels of a transcription factor involved in controlling genes involved in fatty acid breakdown, as well as its target genes, were increased in rats fed soy protein. Thus, feeding rats a soy-rich diet reduced the amount of fatty acid in their liver by not only reducing lipid production but also by increasing its breakdown. Although further research is needed, Dr Torres believes that consuming soy protein could very well reduce insulin resistance, renal damage, and fatty liver, improving quality of life. ]]> <![CDATA[Agri Biotech Industry's Wish List]]> https://biospectrumindia.com/news/95/2094/agri-biotech-industrys-wish-list.html https://biospectrumindia.com/news/95/2094/agri-biotech-industrys-wish-list.html Wed, 07 Dec 2005 15:37:00 +0530 Agri Biotech Industry Agri Biotech Industry's Wish List The agriculture industry contributes 22 percent to the Indian GDP and has been facing many problems. A major issue is that it is a highly regulated industry with a wide range of independent Acts and bureaucratic procedures. Kapil Sibal, minister for science and technology, during the first Biotech CEO Summit organized by BioSpectrum in Hyderabad on September 23, 2005, had asked the agri biotech companies to come out with a wish list so that he could take up the issues with the officials concerned. Some of the recommendations from the agri biotech industry are as follows: The Patents Act: While the third amendment of the Patents Act has made it TRIPs compliant, there is an urgent need to amend the Manual of Patent Procedure and Practice on the lines of the industrialized nations quickly. This would facilitate proper examination of the patent applications. Training of patent examiners: Crop Biotechnology is a very complex science and is relatively new to the Patent Examiners. Hence intensive training of the patent examiners designed at clarifying the complexities of the science would be required. Protection of plant varieties and farmers rights: The Authority under the Act is just being established. It is meeting the industry representatives to ascertain their concerns, which is a step in the right direction. However, while implementing the Act, it is hoped that the Authority will fully integrate the concerns of all stakeholders in an equitable manner so that innovation and technology are given a push. Approvals: We need to shift from hybrid-based approvals to event-based approvals, as is the practice in most countries. This will not only bring our system in harmony with the regulatory systems prevalent in other developed countries but will also make it faster and easier. Once the event has undergone the biosafety trials and found to be safe from all considerations, its positioning in any new hybrid should not pose any danger to the health of the environment, human beings and animals.  The approval process for commercialization of approved events should not take more than two years as only agronomic evaluation is further required. Agronomic evaluation of the product can be part of post-approval monitoring, but should not be a pre-condition for approval. Approval of transgenic technology should solely be based on scientific evaluation of biosafety and validation of the specific claims made for the technology (efficacy testing). There is still an opportunity to reduce the time period required for approval of hybrids for an approved gene. In fact the total approval process for such hybrids should not take more than two years while it is taking three years now. We have to review why each trial is required for such hybrids including the ICAR trial of two years, the LST and the RCGM trials. This streamlining will help in bringing the approved products faster into the market thereby reducing the dependence of the farmer on unapproved products. There should be no restriction on commercialization of Herbicide Tolerant crops. Worldwide, HT crops have been the most accepted GM crops because of the economic benefits to the farmers. The same is applicable in India as well. Recognize the popular varieties as extant and effective varieties and accord them the same consideration as is given to the notified varieties. The Seed Act 1966 does not make notification a mandatory activity. The market share of the popular varieties is more than the notified varieties, signifying their superiority over the notified ones. It would, thus, be anachronistic not to recognize their value to the farmers. Definitional problems do exist, but these can be solved through dialogue with the industry. Time bound regulatory decisions (the whole process from first submission of application to final approval/denial) after all the field trials should not take more than 30 months. Food and feed sector: The next decade would belong to the food and feed sector. The guidelines/protocols for the testing of food and feed products would need to be established and made transparent, credible, predictable and in line with FAO/WHO/Codex guidelines. Drive against illegal seeds: The presence of illegal Bt cottonseeds in different parts of the country is more than that of the legal varieties. Apart from posing risks of biodisaster, they make a mockery of the regulatory system and the laws of the land. Firm State action to contain and restrict the illegal activities is called for. R&D Priorities: These need to suit Indian requirements. There must be emphasis on biotic and abiotic stresses, increase in nutritional values and lengthening of the shelf life of agricultural products. There is no need to restrict R&D on soybean. Biotech research is cost intensive and encouragement should be given to develop world-class facilities for biotech research. Set up biotech facility of International standard at five centers for supporting Bt research in private sectors at Hyderabad, Bangalore, Kharagpur, Pune and Delhi with latest equipment like sequencers. Education and awareness campaigns: There is a need to carry the stakeholders along as agbiotechnology is a complex and a new science. Hence educational and awareness programs by the State is the need of the hour. An intensive outreach program is called for. The industry would be willing to assist the State in this endeavour in any manner that the Government desires. Consumer acceptance and ownership of the technology: The involvement of the civil society is essential for the success of the program. The State must take initiative in this regard and ensure that the civil society understands the process of risk assessment and management and expresses confidence in its credibility. The industry is willing to fulfill any role assigned to it in this regard. Duties and incentives: Apart from nine equipment (as per Customs Notification No. 11/2005â€“List 27A) that are being exempted from Customs duty, the following equipment may also be considered under duty free equipment for import: PCR Machine /Real Time PCR, high speed refrigerated/non-refrigerated centrifuges, microscopes, incubator shaker, hybridization oven, growth chamber, lyophilyser, gel documentation system, high precision balance, HPLC, gas-chromatograph and high throughput dispensing system. As per present policy, duty exemption is being granted on case-to-case basis. However, the following chemicals may also be treated under Duty Free Items that would help the biotech industry to speed up their R&D activities. The chemicals include Hygromycin B, Phosphinothricin/Bilaphos/BASTA, IPTG, TDZ (Thidiazuran), Zeatin, TRIS, AGAROSE (for electrophoresis), Acrylamide, Bis-Acrylamide, TEMED, Ammonium per sulphate, UREA, TAQ-Polymerase, Deoxy nucleotide triphosphates(dNTPs'), Restriction enzymes, Oligonucleotides, Gelrite, X-GlcA, DTT (Dithiothretol), NAD (Nicotine amide Adenine dinucleotide (free acid), X-Gal and SYBR-Green I . There should be a single window clearance for setting up industry at every state. In lines of SEZ create Seed Production Zones (SPZs) to strengthen supporting infrastructure. Exempt all taxes and duties (Sales Tax/Income Tax/TO tax, etc) for all GMO products using indigenous technology. Simplify import of GMO seeds for research purposes. Banks to consider biotech industry as priority sector and give loans at a concessional rate of interest, for longer gestation periods and with exemption from the collateral guarantees, since these industries are not very capital intensive but are research and technology driven. Biopesticides: Wherever registration of biopesticides is required, it should be done by a separate Registration Board, rather than the Central Insecticides Board (CIB). It is hoped that the suggested new Registration Board may view biological inputs differently due to the different nature of the products. Otherwise, the process of registration should be simplified with fewer requirements for toxicology and chemistry data. Bio-efficacy may be given top priority for registering the products. Currently, biopesticides, which are not under CIB schedules, should be allowed for marketing after it is ensured that they adhere to the quality and performance as per the claims made by manufacturers on the label. A uniform policy should be implemented in all the states of India for research, development, manufacturing and marketing of biopesticides. Create a policy environment more conducive for the improved production of biopesticides and biofertilizers to enhance the use of these eco-friendly inputs. In most of the states, biopesticides do not appear along with farm inputs in the Sales Tax or Commercial Tax schedules. They attract high tax rates. We suggest exemption of biopesticides from State and Central Sales taxes and also VAT wherever applicable and exemption from Excise Duty. Because the biopesticides industry uses agriculturally beneficial microorganisms in their products, there are no significant pollution issues. Therefore, the clearance from the pollution control department should be made easy. Allow contract research, contract manufacturing and consultancy services for biotech products (including biopesticides) to facilitate overseas clients to outsource their products of their brands and labels, under their licenses and IPRs. Promote the concept of small and medium enterprises (SME) for the production of biopesticides rather than small-scale industries (SSIs). Charges for testing, bio-efficacy, toxicology data and technology transfer should be made cheaper to facilitate small and growing biopesticides industry. It is therefore recommended that these services be rendered by ICAR, ICMR, SAUs, and other private/public toxicology institutions recognized by CIB-RC. Quarantine facilities should be available at all air and sea ports to facilitate biotech products in terms of their technicalities and faster clearance. Most of the tenders for biopesticides are not possible to go by the L1 concept since these are brand specific than product specific and differ largely due to potency. Dosage per unit area and application cost and methods should be the determinants. Industrial subsidies of minimum 25 percent without upper ceiling may be considered for a fast growth of the biopesticides industry. The above suggestions were given by RK Sinha, Executive Director, All India Crop Biotechnology Association (AICBA), PS Dravid, President, JK Agri Genetics, Clive J Pegg, Managing Director, Proagro Group, M Ramasami, Managing Director, Rasi Seeds, Ram Kaundinya, Managing Director, Emergent Genetics India, Laxminarayan Rau Praharaju, Managing Director, AG Biosystems, and K K Narayanan, Managing Director, Metahelix Life Sciences. ]]> <![CDATA[Nish Patel is MD of Alfa Laval]]> https://biospectrumindia.com/news/95/5751/nish-patel-is-md-of-alfa-laval.html https://biospectrumindia.com/news/95/5751/nish-patel-is-md-of-alfa-laval.html Wed, 07 Dec 2005 15:34:00 +0530 Nish Patel is MD of Alfa Laval Nish Patel is MD of Alfa Laval Nish Patel Nish Patel is the new managing director of Alfa Laval India Ltd. He took charge from Satish Tandon on October 17, 2005. Prior to this, he was heading Alfa Laval Ltd UK as managing director since 2001. His successful career at Alfa Laval began in 1984 when he joined the company as a design engineer at Alfa Laval UK. Within a few years, he was promoted as a sales manager and in 1990 he became general manager for Alfa Laval's Process Industry business in the UK. In the years that followed, he held the positions of managing director of Alfa Laval Thermal Ltd in the UK and director of Alfa Laval's flow business in the UK. Over the years, the Uganda-born and UK-bred Nish Patel, a chemical engineer by profession, has been active in a number of important Alfa Laval projects. Among others is the introduction of the Thermal software CAS - a tool that helps engineers design and configure heat exchangers to suit specific duties. He was also involved in the start-up of a joint venture with Rolls Royce. Kiran Mazumdar-Shaw feted Kiran Mazumdar-Shaw Kiran Mazumdar-Shaw, chairman and managing director, Biocon Limited has been honored with the Corporate Leadership Award for the year 2005 by the American India Foundation (AIF) for her leadership role in promoting initiatives to support environment, education, health and welfare-related issues in India. The ceremony was held at the second Annual Fall Benefit Gala in October at San Jose, California. The event raised $1 million towards furthering AIF's mission in its three thematic pillars of work in India: Education, Livelihood and Public Health. Dr Vijay Kelkar, RA Shah join Lupin Board Lupin has announced that economist Dr Vijay Kelkar and solicitor RA Shah have joined the company's Board as independent directors. Dr Kelkar was an advisor to the Union finance minister between August 2002 and September 2004. A PhD from the University of California, MS from the University of Minnesota, Dr Kelkar has also served as an executive director of the International Monetary Fund (1999 â€“ 2002) and finance secretary to the Government of India in 1998-99. He has held various other senior positions in the government. Dr Kelkar was chairman/member of several high-powered committees set up by the government. A solicitor specializing in broad spectrum of corporate laws, RA Shah is a senior partner of Crawford Bayley & Company. Shah serves on the boards of various companies being on the managing committee of the Bombay Chamber of Commerce and Indo German Chamber of Commerce. He is also a member of the committee for revision of SEBI Takeover Code and President of Society of Indian Law Firms (Western region). Dr Desh Bandhu Gupta, chairman, Lupin, said, "I am delighted that Dr Kelkar and Shah accepted our invitation to join our Board. Their enormous experience and wisdom will serve Lupin in good stead in the years to come". Ranbaxy honors Indian scientists Dr Nita Bhandari Dr Mohan K Raizada Dr Bharat B Aggarwal Dr Asit K Chakraborti Ranbaxy Science Foundation has announced its Annual Research Awards for the year 2004 to the Indian scientists, in recognition of their outstanding research contributions made by them in the field of medical and pharmaceutical sciences. The awards were presented by the Nobel Laureate Prof. Rolf M Zinkernagel, director, Institute of Experimental Immunology, University of Zurich, Switzerland on November 28, 2005. Medical Sciences (Basic Research): Dr Bharat B Aggarwal, Professor of Cancer Medicine (Biochemistry) and Chief, Cytokine Research Section, Department of Experimental Therapeutics, The University of Texas, and Dr Amitabha Mukhopadhyay, Staff Scientist V, Cell Biology Lab, National Institute of Immunology, New Delhi, were chosen jointly for the award. Dr Bharat B Aggarwal received the award for his outstanding contributions in the field of cytokine research, while Dr Amitabha Mukhopadhyay received the award for his contributions to biomedical research on the fundamental issues pertaining to host-pathogen interactions that provided conceptual leads towards the identification of new chemotherapeutic target. Medical Sciences (Medical Research): In the area of Medical Research, Dr Mohan K Raizada, Professor, Department of Physiology and Functional Genomics, College of Medicine, University of Florida, received the award for demonstrating that systemic gene transfer, targeting the rennin-angiotensin system (RAS), a viable strategy for long-term control of hypertension and related cardiovascular complications. Medical Sciences (Clinical Research): In the area of Clinical Research, two scientists were selected by the jury to share the award. They were Dr (Mrs) Nita Bhandari, Joint Director, Society for Applied Studies, New Delhi and Dr Vinod Kochupillai, Chief, Institute of Rotary Cancer Hospital & Professor & Head, Department of Medical Oncology, AIIMS, New Delhi. Pharmaceutical Sciences: In the area of Pharmaceutical Sciences also, the jury selected two scientists to share the award. They are Dr B Gopalan, Chief Scientific Officer, Matrix Laboratories Ltd and Dr. Asit K Chakraborti, Professor and Head, Department of Medicinal Chemistry, National Institute of Pharmaceutical Education and Research (NIPER), Punjab. Dr Gopalan receives the award for designing and developing a series of novel, orally active small molecules in Diabetes. Dr Chakraborti won the award for his contributions in developing new organic reaction methodologies. Seed companies initiate measures to check child labor Initiatives by two top seed companies, a combination of Incentive and Sanction system for farmers under Project "Harvest of Happiness" is showing positive impact, says Association of Seed Industry (ASI). The tradition of employing child labor in cotton seed production in Andhra Pradesh is on the wane. In fact, compared to last year, there has been a major reduction in the number of children being employed in the cotton seed fields of some ASI companies in the 2005-06 production year. The positive impact was following the initiatives taken by Proagro Seed Company, a subsidiary of Bayer, and Emergent Genetics (Monsanto), which have their cotton seed operations mainly in Andhra Pradesh. VR Kaundinya, Director, ASI, India and Managing Director, Emergent Genetics said, "Child labor is a deeply rooted socio-economic problem that has developed in the last three decades in this industry. The decline in child labor can be largely attributed to the combined efforts of some ASI member companies." Proagro and Emergent Genetics as a part of their action plan chalked out a project titled the "Harvest of Happiness" based on a "Village concept". The project is being carried out in 30 Preferred Villages, which have been identified as having a high proportion of cotton seed producers under contract to both the companies. This project was conceptualized in consultation with a prominent NGO working on child rights issues and is being implemented by CLEG (Child Labor Eradication Group) within ASI. Clive J Pegg, Director, ASI and Managing Director, Proagro, added, "Under the project 'Harvest of Happiness', Proagro and Emergent Genetics pay the farmers a bonus on the procurement price if they discontinue the use of child labor. In case of breaches of the contract the bonuses are cancelled and the procurement price cut by 10 percent. In very grave breaches, the contract will be cancelled and the seed refused. In addition to this, there are other initiatives under 'Harvest of Happiness' Project that are playing a key role in reducing child labor. One of the highlights of this Project is revitalizing education initiative launched in collaboration with Naandi, a well-known NGO working in educational programs. The Project involves establishing Creative Learning Centers in cotton seed production villages of Proagro and Emergent Genetics where cotton seed production children will be integrated into mainstream education. In addition to the above project , Proagro and Emergent Genetics have also been actively pursuing other interventions including raising seed productivity to improve farmer profitability and a seed production trial in collaboration with Government of Andhra Pradesh involving "women self-help groups" (Velugu Project). ]]> <![CDATA[Arogya Raksha Yojana conducts diabetes screening camp]]> https://biospectrumindia.com/news/95/1653/arogya-raksha-yojana-conducts-diabetes-screening-camp.html https://biospectrumindia.com/news/95/1653/arogya-raksha-yojana-conducts-diabetes-screening-camp.html Wed, 07 Dec 2005 15:32:00 +0530 Arogya Raksha Yojana conducts diabetes screening camp Arogya Raksha Yojana conducts diabetes screening camp On the occasion of World Diabetes Day, Biocon Foundation and Narayana Hrudayalaya jointly conducted a diabetes ccreening camp at Huskur village near Bangalore. The camp was conducted as part of the Arogya Raksha Yojana (ARY) program for rural India undertaken by the above two organizations. With a view to increase awareness on diabetes care and management amongst the rural population, ARY diabetes screening camps were held throughout November at Kanakpura and Anekal taluk, in Karnataka. It was found that though the incidence of diabetes in the general population of India is approximately 9-10 percent, awareness on this illness is extremely inadequate in rural areas. This is an illness that can be treated and kept under control, but if left untreated it can be debilitating. Biocon organizes 'Winning Colours' for juvenile diabetics Biocon Ltd organized 'Winning Colours', a painting competition for juvenile diabetics. The event was dedicated to raise awareness about the alarming rise of juvenile diabetics on the occasion of World Diabetes Day and Children's Day. The event highlight was a canvas painting by artist Yusuf Arakkal and the winners of the painting competition. In addition, a cheque was presented to Jnana Sanjeevani, a Bangalore-based NGO working for the cause of juvenile diabetes. Every child was a winner at the 'Winning Colours' competition and twelve of the best paintings were short-listed to be used in a Biocon sponsored calendar for the year 2006. On the occasion, Insugen.com â€“ a dedicated portal for diabetes management and care was launched by legendary actress Waheeda Rehman, for the benefit of patient and doctor groups. "Uttaranchal, an ideal biotech destination" "The biodiversity, presence of diverse agricultural zones, R&D institutions and universities coupled with the high priority accorded to the sector by its state government has made Uttaranchal, an ideal biotechnology destination," said Dr L M S Palni, senior scientific advisor and project director- State Biotech Program. Speaking at a seminar on "Business Opportunities in Agribusiness and Biotechnology" in Delhi, he said Uttaranchal had many opportunities in fields such as bio fuels, biopesticides, phytochemicals, bioinformatics, diagnostics based industries, biotech based production of seeds, pharmaceuticals and nutraceuticals. Pfizer's inhaled insulin permitted for trials in India Pfizer's inhaled insulin drug candidate, Exubera, which is used for the treatment of Type 1 and Type 2 diabetes, has been given the permission to conduct clinical trials in India. According to Panaba Lakshmi, minister of state for health, Exubera, which is currently in Phase III clinical trials abroad, has been given the permission to conduct the trials in India as part of its global trials. Quintiles will be conducting the trials with the inhalable insulin in India. The Indian spokesperson of Pfizer (India) declined to comment on this, as the development was connected to Pfizer Inc. When contacted, Dr AB Rameteke, deputy Drugs Controller General of India, said he was not in a position to throw more light on this development. Once approved by regulators in the US and around the world, Exubera is expected to provide an important new insulin delivery modality for patients with Type 1 and Type 2 diabetes. Pfizer and Sanofi-Aventis have a global agreement to co-develop, co-promote (where permitted by law), and co-manufacture inhaled insulin. US-based Nektar Therapeutics is responsible for manufacturing the fine insulin powders and supplying the inhalers. Acambis joins hands with Bharat Biotech Acambis plc, a vaccine developer based in Cambridge, has established a manufacturing and marketing agreement with Bharat Biotech International Limited, relating to Acambis' ChimeriVax-JE investigational vaccine against Japanese encephalitis ("JE"). Under the agreement, Bharat Biotech will be responsible for end-stage fill/finish processing of ChimeriVax-JE at its facilities in India and, once ChimeriVax-JE is approved, will market and distribute the vaccine in India and neighbouring countries. Quoting Gordon Cameron, chief executive officer of Acambis, the release said, "The scale of the current epidemic in India has highlighted the critical need for a safe, efficacious and cost-effective vaccine against JE. We believe that the forthcoming Phase III trials of ChimeriVax-JE will demonstrate our vaccine can meet that need and Bharat Biotech is the ideal partner to help us to maximize ChimeriVax-JE's reach." Dr Krishna M Ella, CMD, Bharat Biotech International said, "This partnership with Acambis will enable us to bring a much-needed and improved JE vaccine to children in the Indian subcontinent, a region currently suffering from an epidemic that has so far killed over 1,000 children." Anamol Labs to manufacture healthcare products Anamol Laboratories, a Pune-based pathology lab was acquired by M J Dashora, (then managing director of Accurex Biomedical in 2004) to venture into manufacturing of healthcare products of latest technologies under an independently new banner having ultra modern, state-of-the-art plant facility. Speaking to BioSpectrum, M J Dashora, managing director, Anamol Laboratories said, "Biotechnology has grown far and wide during last 15 years. But most of these technologies are expensive and confined to research laboratories. Making these available to common masses at affordable cost is our main focus. We are committed to implement and popularize the latest developments in the field of clinical chemistry, food biochemistry, food toxicology and molecular diagnosis of diseases." Anamol's primary objective was to provide world-class health care services to common patients at affordable cost. It was shifted to Tarapur (Boisar) for establishment and efficient functioning of the upcoming 25,000 sq. feet plant facility. It strongly feels that excellent advancements in these fields move out from research laboratories to industry making them available for use in pathology and analytical laboratories. Virchow Biotech to start clinical trials with VIRKINASE Hyderabad-based Virchow Biotech has received the green signal from the Genetic Engineering Approval Committee (GEAC) to conduct of clinical trials with VIRKINASE in India. Virchow Biotech has indigenously developed VIRKINASE- recombinant Streptokinase. The company proposes to conduct a multi-centric randomized double- blind study in a total number of 75-100 subjects aged between 18-75 years with acute myocardial infraction fulfilling the eligibility criteria. The clinical trials will be conducted at five CARE Hospitals in Hyderabad. The GEAC noted that RCGM has recommended the product for Phase â€“III clinical trials in its meeting held on May 25, 2005 based on the pre-clinical toxicity data generated in rats and rabbits. The committee also noted that the product r-Streptokinase is a drug approved for marketing in India. After detailed deliberations and taking into consideration the recommendation of RCGM, DCGI and the expert members, the committee approved the conduct of clinical trials with VIRKINASE in India. NPIL signs manufacturing pact with global firm Nicholas Piramal India Ltd has signed a long-term manufacturing and supply agreement with a large global hospital products company. The agreement is for an initial term of ten years, followed by yearly renewals. This agreement represents an exclusive partnering arrangement between the two companies for certain global markets. According a company's release, NPIL will manufacture and supply select hospital care products to the company. The agreement provides an avenue for addition of further products under the arrangement. NPIL will manufacture the products at its USFDA-approved facilities at Digwal, Andhra Pradesh. Revenue from the initial set of products is expected to range between $12-15 million per year. Hikal acquires stake in Chinese company Hikal Ltd, a technology driven company has entered into a joint venture agreement by acquiring a minority stake in one of Sinochem Corporation's subsidiary company. Sinochem of China is a "Fortune 500" company. The acquisition will enable the company to backward integrate for sourcing some of its intermediates and APIs. Hikal is already sourcing intermediate from Sinochem for one of its products. Speaking on the occasion, Jai Hiremath, vice chairman and managing director, Hikal said, "This joint venture will help Hikal improve its cost base, as we see many sourcing opportunities of raw materials and intermediates for our APIs. The association with Sinochem will open up new avenues for marketing and sourcing of products in different markets." Earlier, in 2004, Hikal, involved in custom synthesis and manufacturing of Active Pharmaceutical Ingredients (APIs), Intermediates and Crop Protection products, had acquired a majority stake in Marsing & Co., Denmark. Wonder plant to cure diabetes Stevia, a high value medicinal plant whose dry leaves can be used by diabetics, has been successfully cultivated in Debang valley district of Arunachal Pradesh and is ready for commercial harvesting. PB Kanjilal, head of medicinal plant division of Regional Research Laboratory (RRL) of Jorhat, said the laboratory had adopted several villages at Roing in Debang valley to motivate 300 farmers to cultivate the plant whose leaves are far sweeter than sugar and can be used by diabetics. Novartis India seeks permission to import Xolair Novartis India intends to import Xolair (omalizumab) in finished formulations from the US for marketing in India and has sough the permission of the Genetic Engineering Approval Committee (GEAC) for the same. Xolair is a recombinant humananised monoclonal antibody (protein) indicated for the treatment of asthma and is administered via subcutaneous injection. The GEAC noted that, while clinical trials on Xolair have been done in over 4000 patients in 20 countries including the US, the UK, Australia, Germany, Canada, France, and Switzerland, the product is said to have been approved for marketing in Australia, Brazil, Chile, Colombia, Dominican Republic, Guatemala, Israel, New Zealand, Pakistan, Palestine, the US and Venezuela. After detailed deliberations at its October meeting GEAC has decided to seek the information from the applicant such as the status of approvals in the countries where clinical trials have been conducted, details of the clinical trials with type and categories of patients tested in other countries and status of issue of market authorization by DCGI. ]]> <![CDATA[Outstanding Winners]]> https://biospectrumindia.com/news/95/1083/outstanding-winners.html https://biospectrumindia.com/news/95/1083/outstanding-winners.html Wed, 07 Dec 2005 15:17:00 +0530 Outstanding Winners Outstanding Winners I t is December again. And it is time for the annual BioSpectrum Awards for the biotechnology industry. The winners of the 3rd BioSpectrum Awards are profiled in the current issue of the magazine. From these profiles, it will be clear that each of them is a deserving winner for adding something unique to the development of biotechnology in the recent past. The jury, chaired by Dr Cyrus S Poonawalla, the BioSpectrum Person of the Year 2004, assisted by some of the most eminent personalities representing a cross section of the industry, deliberated over two hours in Pune and unanimously chose the winners. Dr Poonwalla, however, stayed out and left it to Pune University vice chancellor, Prof. AS Kolaskar to guide the meeting while picking the Product of the Year award to avoid any conflict of interest. The combination vaccine from Serum Institute, headed by Dr Poonawalla, was in the shortlist for this category. The comments from technology leaders like Dr R A Mashelkar, Prof G Padmanaban and Dr Manju Sharma about the awardees like Dr MK Bhan and Dr NK Ganguly clearly vindicate the jury's decisions. As Dr Mashelkar pointed out, BioSpectrum has honored itself by the decision to bestow the Life Time Achievement Award to Dr Ganguly. This certainly is the case. In the inaugural year itself, the magazine instituted the Awards to recognize the outstanding performances of individuals and organizations whose enormous contributions were key to the growth of the industry. BioSpectrum provided the neutral platform for the industry to come together and pick the performers on the basis of widely defined parameters. Almost all the awardees in the last two years have gone on to add more laurels to themselves and the industry. The first awardee, Kiran Mazumdar-Shaw (Person of the Year in 2003) has emerged as icon for the whole country in a short time. Dr Poonawalla (Person of the Year in 2004) was honored by the nation with the Padma Shri award a month after the BioSpectrum Awards function. Entrepreneurs like Dr Krishna Ella and Dr KK Narayanan have carved a name for themselves in the industry pantheon with pathbreaking initiatives. The products picked by the jury in the last two years have made great impact in the market place. Looking back at the year that is about to end, the biotechnology industry could be justifiably proud of its growth, and the increased acceptance and indeed the growing expectations being thrust on it by a nation looking for another winner in the global economic sweepstakes. The nation has responded by the government's road map to remove various hurdles hampering the growth of the sector. The industry too is reciprocating the nation's support. The slew of products being brought out, including a biotech acrylic paint by a Chennai-based company, in November, is a clear indication that biotechnology is here to stay. The Rs 70-crore Stem Cell Research facility inaugurated by President APJ Abdul Kalam at the well-known Christian Medical College, Vellore, Tamil Nadu, is yet another addition to the country's strategic decision to garner the benefits of a cutting-edge technology, avoiding the pitfalls of a prolonged national debate hampering its progress even in some advanced nations. ]]> <![CDATA[China Shining]]> https://biospectrumindia.com/news/95/2583/china-shining.html https://biospectrumindia.com/news/95/2583/china-shining.html Wed, 07 Dec 2005 15:13:00 +0530 China Shining KV Balasubramaniam, Managing Director, Indian Immunologicals Ltd (IIL) BV Rama Subba Rao, Manager - Exports, IIL China Shining With a market size of over $20 billion, China will be poised to pose a threat to the Indian pharma industry in the years to come. T he market in China in every segment is huge and growing, considering that it is the most populated country in the world and a rapidly growing economy. Doing business with China has been made more attractive by wide reaching series of reforms. But this is not easy. We have to scale the 'great wall' of regulatory and trade barriers and take on intense competition from local companies, and leading MNCs. In seeking markets for our products in China, chances are that we may end up procuring a few items, considering the hugely discounted prices of many products. That is China. Sino-India Trade Ties Bilateral relations between India and China have been steadily improving in the last two decades. In 1984, the two countries signed the Most Favored Nation agreement. The India China Joint Group on Economic Relations, Trade, Science and Technology (JEG) was established in 1988 during the visit of late Prime Minister Rajiv Gandhi to China. From then onwards, quite a few high profile exchanges and visits have taken place, resulting in constant strengthening of bilateral relations. The pharmaceutical industry in both countries has significantly has benefited fro this. Market Overview Health Sector Before we understand the pharmaceutical market in China, we need to look at the user segment that it caters viz., health sector. Due to multiple factors such as higher living standards, enhanced health awareness and ageing, the health sector in China has grown at a steady pace of about 16 percent per annum over the decade. China spends about 5.3 percent of its GDP on health related expenditure with a per capita expenditure of about $45 per head (Year: 2000). As per World Bank study of 1998, China should be spending about 10 percent of its GDP i.e., over $100 per head to take better care of the health of their citizens. In spite of several reforms and progress in this sector, infant and child mortality continues to be a matter of concern in China. The public sector still dominates the health sector, and virtually there are no private hospitals, except for a few hospitals that cater to expatriates. For this reason, public sector pharmaceutical units that make 'me too' products at 'affordable prices' continue to flourish. Pharmaceutical Sector The market size of the Chinese pharmaceutical market is over $20 billion, making it the second largest in Asia, next to only Japan. Keeping pace with the growing economy, pharmaceutical market has witnessed a growth rate of over 14 percent steadily over the past 15 years. The market has so far been dominated by non-branded generics and the industry operating with basic technology and simple production methods. With China's entry into WTO there are sweeping changes taking place. China's pharmaceutical industry is in a state of continuous transformation, with ongoing mergers, consolidations and new investments. In its overall drive for modernization, the Chinese government has implemented several major changes, including the reorganization of State Food and Drug Administration (SFDA), key amendments to drug regulation, bringing in WHO GMP standards along side enhanced intellectual property protection and changes in import drug licensing. Intellectual Property protection The Chinese government promulgated several laws in the year 2002, to improve Intellectual Property (IP) rights. As part of WTO accession, China extended all patent coverage to 20 years. SFDA is also putting in place many regulations for greater hormonization in regulatory and technical requirements, using ICH guidelines for reference. Industry consolidation Currently consolidation, alliance and acquisition are buzz words for growth and rationalization. The government continues to encourage regional mergers. Recent examples include the formation of Shijianzhuang Group in 1999, a combination of Weisheng Pharma, a Hong Kong listed joint venture and Hebei Pharma Factor, a leading antibiotic factory. The Shanghai New Asiatic Pioneer Group, which was formed in 2002, combines three major API factories; New Asiatic, Shanghai Pioneer and Shanghai No.3. There are many more examples of mega mergers. GMP compliance is now compulsory for the renewal of manufacturing licenses. According to SFDA, the GMP regulations in force in China are largely based on WHO guidelines. It is costing each manufacturer a substantial sum of about $3.5 million to upgrade their facilities. As of now about 1800 facilities are certified and about 1000 facilities are uncertified. This is likely to result in mergers of financially weak enterprises resulting in industry consolidation. Many companies in China want to work with West, not to secure any capital, which China sought in 1980s and 1990s, but for exposure to modern management and quality control practices. Ping Zhicun, president of NCPC Beta Company notes: "It is not technology we lack anymore, but the management techniques which have already been implemented and followed by Western pharmaceutical factories for years. For us to get up to speed will take years - a cooperation will enable us to lessen the gap quickly" Custom manufacturing is another area factories are trying to develop, particularly for intermediates where there are fewer foreign regulatory requirements. There are exclusive facilities coming up in different provinces for contract manufacturing services. Government support The government is also playing its part to help pharmaceutical companies in their efforts to modernize. In July 2000, it announced that it would be encouraging non-pharma enterprises to invest in pharmaceuticals. This has resulted in quite a few large non-pharma companies pumping in fresh investments into the pharmaceutical sector. The government is also welcoming foreign investment in state-owned enterprises and has recently allowed them to invest in unlisted state-owned enterprises. The government is also funding liberally research institutions and encouraging their tie-ups with the industry. Pharmaceutical companies have also increased their R&D spend from an average of 1 percent of sales, just 5-6 years ago to about 5 percent now. China is determined to become a major player in global pharma. When asked to identify the major Western misconceptions about China, Zhang Jianhi, CEO of Shandong Lukang, says, "Foreigners continue to underestimate the capabilities of China, both in terms of technology and quality but more over speed. They fail to recognize the significance and impact of past 20 years of continuous improvement and changes in China's pharma industry". Long term threat should not obscure immediate opportunities for Indian companies for partnerships and supply arrangements particularly in API and Intermediates segment. We have to consolidate the early mover advantage that we have in pharma segment and accelerate further to stay ahead. From India, Aurobindo, Dr Reddy's, Orchid and Ranbaxy have established successful joint ventures. This is in the league of leading MNCs such as GSK, Bristol Mayor & Squib, Astra Zeneca, Boehringer Ingelheim, Johnson & Johnson and others, who have established their manufacturing presence long ago. Vaccine Industry China's human vaccine market size is about $800 million. So far the market was dominated by MNCs such as Aventis, Merck and GSK. Serum Institute had been exporting MMR and others to China. But the local industry is fast catching up with increased capacities and wider range. Well established state owned companies such as CNBC (China National Biotech Corporation) offer a wide range of vaccines including Japanese Encephalitis, Rotavirus, Meningitis (Group A+C), Typhoid vaccine and DTaP. They have established tie-ups with world leaders in various segments such as technology transfer, production, packing and marketing services. There are number of small vaccine producers such as Chengdu Institute, Lanzhou Institute, Shenzen Kangtai, National Vaccine and Serum Institute, Kunming Institute of Medical Biology and Beijing Institute of Biological Products. China has 7 vaccines in the EPI programme. Hepatitis B is the additional one product in the EPI list compared to India. China is in receipt of GAVI's support and this will continue till 2007. Regulatory Framework The State Food and Drug Administration (SFDA) was established in the year 1998 to oversee pharmaceutical product registration as well as importation. The pharmaceutical registration is extremely complex and also time consuming. This is due to the involvement of number of bodies at various levels of government and regions. Evaluation procedure is reportedly tougher for imported products in comparison to domestic ones. It will take about 18â€“26 months for product registration, considering the level of rapport, you enjoy with the drug administration department. Conducting clinical trials on local population is necessary for biologicals and it is an expensive and time consuming affair. Trade Barriers China is reforming its tax system to minimize distinctions between domestic and foreign entities according to the WTO principles of national treatment. However, as a measure of protection for domestic industry, imports are restricted through a variety of means including non-tariff measures such as import licenses, import quotas and testing procedures. Laws and regulations in China tend to be far more general than in most of the developed countries. This vagueness allows Chinese officials to apply them flexibly, which results in inconsistencies. Companies sometimes have difficulties determining precisely whether or not their activities contravene a particular regulation. Agencies at all levels of government have rule-making / interpreting authority, resulting in regulations that are frequently contradictory. Finally, while there seems to be no shortage of rules and regulations, there are few procedures in place to appeal regulatory decisions. Animal Health Segment As a result of heavy industrialization and export trade, urban incomes have risen significantly over the last two decades, but still around two third of China's 1.3 billion population lives in rural areas and dependent on agricultural output, where the incomes are less. Live stock production is an important contributor (30 percent) to country's agricultural output. In response to the population growth and rising per capita demand, the livestock numbers and output of meat are steadily increasing. Though the live stock numbers are massive and meat output huge, production is dominated by small farmers, often rearing a handful of animals. The 'back yard farmers' with five or less animals account for more than three fourths of the total pork production. Considering the size of meat production, China is still a minor player in export market for meat. Following China's accession to WTO trade barriers are dismantled and the country's export/import trade in meat product is likely improve significantly in the coming few years. China accounts for about 8 percent of the world animal health market and is growing very fast. The turnover of its animal health market is about $1.02 billion with a growth rate of about 10 percent over the last decade. The market is spread among local players, JVs and MNCs. While local players including joint ventures with MNCs have substantial capacities for AH products including biologicals, MNCs have strong presence with their high-end product portfolio and marketing muscle. MNCs such as Merial, Intervet, Fort Dodge, Pfizer, Bayer, Novartis and UBI have their presence with own manufacturing facilities / JVs / Acquisitions. Market among the local players is highly fragmented with no one holding more than 3 percent market share, with the exception of CAHIC (China Animal Husbandry Industry Company Ltd) having about 20 percent market share in AH segment. CAHIC owns majority stake in 16 local companies and minority stake in 9 other local companies, including manufacturers of biological products. They have a huge, cross-country marketing and distribution network. Some of the MNCs also utilize their distribution network. Animal Health Vaccine Industry Consumption of veterinary vaccine is steadily increasing in excess of average market growth due to more intensive disease control programs. Regular administration of preventive vaccination is mandatory in respect of ten diseases, including swine fever and number of serious poultry diseases. The local industry is building huge capacities for the production of FMD Vaccine, Poultry Vaccines and Swine Fever vaccines and a wide range of biologicals. For example the combined capacity of 4 leading FMD producers is in the range of about 2.0 billion doses of FMD. Qian Yuan Hao biological company produces about 14 billion doses of Avian Influenza vaccine to meet 30 percent of the domestic demand. So far, their production was directed for domestic use and partly the vaccine market was catered to by the MNCs. As the industry consolidates, more and more local companies and JVs are likely to dominate the domestic segment and also offer competition in the international market. A Giant in the Making It can be observed that China is really a giant in the making in the pharmaceutical industry, in both the human health and animal health segments. They have a strong domestic market and very competitive factors of production. Until recently, they were inward looking and as a result not at par with western countries, or even India, on product quality or regulatory aspects. However, with China joining the World Trade Organization (WTO) and with growing aspirations to be a world player, they have begun the task of radically improving technology, manufacturing ability and regulatory standards. They will definitely pose a threat to India in the coming years, especially in the international generics market, where India has an early mover advantage. Likewise, their vaccine industry is improving its prowess and is bound to challenge India's current superior position. To design our export strategy, China cannot be just looked at as a market which will import our products. It is too large to be served from an offshore location. More than that, it has to be looked at as a market where local presence is a must. We must acknowledge their strengths, look to building complementarities in export trade and attempt to build strong and mutually beneficial relationships with good companies. It is in this manner that exports can be sustained in China in the long term. ]]> <![CDATA[Boosting Bioclusters]]> https://biospectrumindia.com/news/95/2427/boosting-bioclusters.html https://biospectrumindia.com/news/95/2427/boosting-bioclusters.html Fri, 11 Nov 2005 14:25:00 +0530 Raising The Biotech Bar Boosting Bioclusters As India's biotechnology industry moves ahead, comparisons with other countries are bound to follow. Are we along the right track? Are we adopting the best practices of the successful biotech industries in other parts of the world? These are some legitimate questions many stakeholders in the Indian biotech sector are asking these days when they meet each other. Ocimum's L Subhash raised this issue during the Cross Talk organized with S&T Minister Kapil Sibal at the First Biotech CEO Summit organized by BioSpectrum in September. And Sibal replied that Dr M K Bhan, secretary, DBT, was working out the contours of strengthening India's bioclusters. BioSpectrum editorial team too asked these questions to various industry leaders and have put together a comprehensive feature on the status of India's emerging bioclusters. There are many claimants to the biocluster tag. Almost every state has announced the intention to pursue biotechnology vigorously, having realized that many had missed the 'information technology bus'. Each state is trying to build on its strengths in terms of availability of resources, key ingredients, research centers and human resources. But what is clear from our report is that five bioclusters are emerging in the country-Bangalore, Hyderabad, Mumbai-Pune, New Delhi-Lucknow and Chennai. Three of these clusters have already found a place in a recent global listing of bioclusters by a US-based agency. This is certainly heartening because two years ago, India itself did not find a mention in a global listing of bioclusters. Of course, not everything is in place in these emerging bioclusters. There are many missing links in all these places. What is heartening however is the fact that the key players in these clusters are aware of the gaps and policy makers too, led by Dr Bhan, are determined to make sure that the gaps are filled faster. So these clusters are going to play to their strengths. And other clusters centered around proteomics and genomics too may emerge in the future in and around these existing clusters. The industry now looks upto Sibal and Bhan to provide it with all the help and make the path clear while announcing the final National Biotechnology Strategy Document. The blueprints for strengthening bioclusters will get the boost with the cabinet approval expected before the year-end. In another related development, where government policy clearly has a major role in propping up an industry, the Biofuel sector has something to cheer. The government's decision to allow oil companies to buy biodiesel at Rs 25 per liter is a major boost to the fledgling sector. Over dozen biodiesel producers have been waiting just for this announcement, which has the ability to provide a regular marketing outlet for their products. The government has already announced a graded increase in the percentage of blending allowed for biodiesel with conventional diesel. Almost all the experiments using biodiesel in automobiles done recently have given glowing reports about its effectiveness. With the petroleum prices ruling very high, biodiesel may come in as a savior to the energy-intensive Indian economy. ]]> <![CDATA["DBT will help in creating missing links in existing biotech centers"]]> https://biospectrumindia.com/news/95/4601/dbt-will-help-in-creating-missing-links-in-existing-biotech-centers.html https://biospectrumindia.com/news/95/4601/dbt-will-help-in-creating-missing-links-in-existing-biotech-centers.html Fri, 11 Nov 2005 14:15:00 +0530 New Page 1 "DBT will help in creating missing links in existing biotech centers" Dr MK Bhan, secretary, DBT, shares his vision about developing biotech-based clusters in the country, in an exclusive interview with Rolly Dureha of BioSpectrum. How would you define a Biocluster? A Biocluster should have a science institution, a technology institution, a medical, an agricultural or a veterinary institution, which are the core discipline institutions. Then there should be the industry and a legitimate clustering effect would be consonance between the institutions and the local industry that is growing in science and technology. A biotech park, a government department focused on biotechnology proactively, an incubator facility, a large number of Small and Medium Enterprises (SMEs) are some of its other components. So a cluster could be broadbased or there could be a cluster oriented to medical or industrial or agricultural biotechnology. It has also to take into account whether the concentration is more into medical, pharma and vaccine, therapeutic, agri or environment industry. There could also be foreign players operating in that area. In addition it can have services, R&D and joint manufacturing companies. In a sense, it has an element of globalization reflected there. Within a specific field itself, a cluster may have focus. For example, if there is a cluster in the area of functional genomics, proteomics, then it should have centers that can do human studies in which both the genopyte and phenotype are assessed. It can have companies that make chip-based biomarkers and are into drug development. It should ideally have a strong translational research unit, a strong clinical research unit and a proteomics group, a basic sciences group focused on proteomics. So, in a sense, a cluster is nothing, but an aggregation of a co-location of multiple capacities that can function as a network, as a web or mesh feeding on each other. Thus if you look at clusters in this way, you can have many different types of clusters and several different clusters in a city. Essentially as long as the various units of a cluster are functionally linked and are working synergistically, the clustering model does not matter and can vary. How do you see the existing biotech centers in the country? Presently in the country, cities like Bangalore, Hyderabad, Pune, Mumbai and even Chennai, to some extent, have developed as biotech centers. Then there are some efforts that have been initiated in a number of other places like Kolkata, Gujarat, Orissa, Himachal Pradesh and Rajasthan. Now as a cluster what is missing in Bangalore? According to me, a great clinical academic centre is missing, which can be built. A translational unit in the big basic science school can be developed. A technology development center, a technology management center and a technology transfer center could be ideally located there. Similarly if you see Hyderabad and Pune, you will find that some pieces of the cluster are there while others are weak. Likewise, Delhi also has great potential. It has excellent scientific institutions but does not have enough concentration of the biotech industry. Delhi's strength in medical schools is great and it is probably the most powerful science city today after Bangaloreâ€“ICGEB, NII, NBRC, NCPGR, and Delhi University are located here but the industry is not here, the biotech park is not here. Besides these city-based clusters, there can also be nation-based clusters and there are two that I would love to do on a national scaleâ€“one on stem cells and another on proteomics, where the partnerships/networks are across the states. This network is also a cluster if it has permanency and is long-lasting. I think the weakest link in all the places is strong medical or agricultural or veterinary research. Our basic science is strong but the domain discipline research is very weak. Another observation is that the partnership between medical research centers and science centers is not very strong and does not exist in a world-class sort of way; like how MIT and Harvard are structured. How is the DBT trying to promote clustering? DBT's strategy is to look at the existing biotech centers and see if we can create the missing pieces. So I would say that we should strengthen medical school research, create one-two centers of excellence of medicine/medical biology both translational biology and clinical research in Bangalore, Hyderabad and other established places so that faster partnerships can develop between them. Like in Bangalore we are promoting a partnership between National Centre for Biological Studies (NCBS) and CMC Vellore. The idea is to strengthen CMC Vellore as a molecular medicine, translational and clinical research centre. We are likely to create a stem cell centre there soon and then we would also like to set up a molecular medicine unit there. At NCBS we are thinking of creating a translational research institute and together they will run a MD PhD program, as we need MD PhDs for translational research. At some point I would like to create a clinical academic center in Bangalore, where good disease biology and good clinical research is done. The stem cell cluster at Bangalore will consist of IISc, NCBS, Manipal Hospital, CMC Vellore and one local company whom we are going to support for production. The missing piece here has been the company and now we have located and spoken to the company. Another thing that I would like to do in Bangalore is to set up a world-class undergraduate course in life sciences; have a place produce work force for the industry and human resource for the companiesâ€“the technicians, the technologists, etc. That could also be an interesting cluster. Then the city of Bangalore could benefit from a graduate school concept in which education at the PhD level is linked with a focused area of work. This is how education can be linked with research and clustering can be promoted. In Delhi I would love to see more biotech companies, start-ups and a biotech park. We are also thinking of making a translational research institute separately in Gurgaon and are also planning to link some patient facility with the National Brain Research Centre (NBRC). As a part of the clustering approach, it would be great to have AIIMS partner with some science institute. Right now the science relationships between the institutes are not great. In Hyderabad we are trying to create another stem cell cluster. Both the stem cell clusters in Hyderabad and Bangalore would find their own niches. For example, one could specialize in mesenchymal stem cell research, while the other would be doing embryonic stem cell long sighted research. So they may have different niches, organs may be different. In one place they may be doing adult cell research and in another place they are specializing in neurological applications. Also, it would also be great for a place like Hyderabad and Bangalore to have one institution where one can get interdisciplinary training. This system will allow horizontal movement, mobility and help in acquiring all kinds of related skills. Then, Punjab will be developed as a biotech corridor as per the recent announcement of the Prime Minister. We are trying to develop several areas including an agri biotech cluster in Punjab. We have visualized a biotechnology park and an institute of agri biotechnology there and there is a possibility of collaborations with Canada in the institute on agricultural biotechnology. Besides, we are trying to build medical biotechnology at PGI, Chandigarh and later would bring in IMTECH and Punjab University. A large number of companies in the agricultural area are moving in the region as the biotech park initiative has started. So for plant biotechnology, horticulture, bioresources, medicinal plants, Punjab could become a cluster. Another way to promote clustering is to reengineer the existing institutions. And principle of that is to strengthen science where there is already domain expertise in medicine, agriculture or veterinary health and strengthen translational capacity and technology development where science is already strong. Hence if we make a background of all the major cities where biotech is happening and find out which are the missing links, then clustering would be to understand and analyze the needs of each of the citiesâ€“assess their strengths, document their weak links and fulfil them. Hence we need to follow a case-by-case approach for each place. Each biotech center has some weakness and they need to be tied. Like in most places the business incubators do not function well, which is one of the biggest weakness and we need to find new solutions. Building customs officials as partners in movement of biological material is another area that we have neglected. Technician schools, industry required human resource and a great undergraduate school, which makes biology the centre of interest in the city and attracts a lot of young talent, are required. Lastly a lot of clustering, of how it happens, depends on the drive of the local groups in each city. It happens best if the local groups are pushing us and we are providing support and feedback and not the other way round. ]]> <![CDATA[Fostering Growth Through Bioclusters]]> https://biospectrumindia.com/news/95/6538/fostering-growth-through-bioclusters.html https://biospectrumindia.com/news/95/6538/fostering-growth-through-bioclusters.html Fri, 11 Nov 2005 14:11:00 +0530 Fostering Growth Through Bioclusters Fostering Growth Through Bioclusters The state governments are contributing their bit towards developing the biotechnology industry in cities having strength and potential but there are a few missing elements. Once everything is in place, with the coordinated efforts of all industry stakeholders, India will have many bioclusters. The United Nations Industrial Development Organization (UNIDO) has identified about 388 clusters in India in various sectors from textile to chemicals and pharmaceuticals to food processing. Of these 11 clusters are situated at Cuttack in Orissa, Hyderabad in Andhra Pradesh, Indore in Madhya Pradesh, Thane, Pune, Aurangabad and Mumbai in Maharashtra, Margao in Goa, Valsad/Bharuch, Baroda and Ahmedabad in Gujarat, all dedicated to pharmaceuticals. These clusters are into bulk/ basic drugs manufacturing. The Minnesota Biomedical and Bioscience Network has prepared a list of the life sciences and biotechnology clusters of the world in which it has included Bangalore, Hyderabad and New Delhi as clusters along with New York/New Jersey, Philadelphia, Baltimore/Washington, DC, Research Triangle NC of the US. Considering all this, the definition of cluster does not remain the same in the present day context. In his classic work on "The Competitive Advantage of Nations (1990)", Michael Porter, a Bishop William Lawrence University professor, based at Harvard Business School introduced the word a cluster as "a geographically proximate group of interconnected companies and associated institutions in a particular field, linked by commonalities and complementarities" where, the "value of the system as a whole is greater than the sum of its parts". The changing economics that have become more complex and competitive, evolving business practices have recognized the advantages of locating firms, sectors or industries near each other or near supply sources. Considering these changes, a cluster can be defined as "a geographic concentration of interconnected companies, specialized suppliers, service providers, firms in related industries, and associated institutions (for example, universities, standards agencies, and trade associations) in particular fields that compete but also co-operate." The Silicon Valley in the US is perhaps the best-known example of a cluster, but there are many other examples in different regions and sectors. Relevance of Clusters Clusters are particularly important in knowledge-based sectors like biotechnology, medical biosciences, life sciences, and information technology, despite the trend towards globalization arising from rapid advances in transport and communication and accessible global markets. This is because the type of knowledge that creates competitive advantage often requires proximity or regular face-to-face interactions and trust in order to be effectively communicated. Earlier studies and analysis demonstrate that clusters can raise innovation and productivity in a number of ways. Companies benefit from sharing knowledge about best practice and reduce costs by jointly sourcing services and suppliers. Frequent interactions facilitate formal and informal knowledge transfer and encourage the formation and efficiency of collaboration between institutions with complementary assets and skills. The critical mass effect attracts further companies, investors, services, and suppliers into the cluster, as well as creating a pool of skilled labor. Local training institutions and infrastructure can provide further benefits for companies. Rivalry between firms can stimulate competitiveness and encourage constant upgrading. Many of these benefits are likely to be more important for SMEs than for larger companies that are more able to capture them internally. Indian BioClusters Green represents biotechnology and life sciences clusters. The concept of clustering definitely has relevance for the Indian biotechnology industry, which has just started moving up the growth ladder. Rajesh Jain, joint managing director, Panacea Biotec said, "Bioclusters would work in India. Such bioclusters will be successful, provided a close interdisciplinary strategy is adopted by cohesive interactions between excellent innovative science and entrepreneur spirit of business leaders and industry friendly policy of the government. The success of bioclusters will not only result in improving the economic development of the country or marking India a global "hub" of biotechnology, it will also generate excellent job opportunities." Sharing similar views, Vibhav Garg, principal-business development, Mascon Life Sciences said, "Bioclustering is a good way of looking at the scattered expertise and experience, which could be complementary to each other, under one roof. This approach is already bearing fruits for rest of the world. I do not see any reason why it will not work in India. The approach is certainly going to benefit the industry and the country as complementary nature of the organizations in a given biocluster will bear fruits for all and hence it will be a win-win for one and all." Rajesh Jain further said, "Bioclusters in terms of development of biotechnology industry have already grown unintentionally as clusters. These clusters are mainly located in the states of Andhra Pradesh, Maharashtra, Karnataka and Delhi. The respective government policies and scientific ambiences have been responsible for the growth of such clusters. A recent example is a cluster of biotechnology and pharmaceutical ventures at Baddi in Himachal Pradesh." Indian BioClusters What Bangalore needs: A clinical academic center A technology development center, a technology management center and a technology transfer center. What Delhi needs: The capital city has excellent scientific institutions but it lacks greater concentration of biotech industries and a biotech park What's lacking in Hyderabad and Pune: Parts of the cluster in both the cities are weak What's on the anvil: A molecular medicine unit and a translational and clinical research center at CMC Vellore. Stem cell center at CMC Vellore. Translational research center at NCBS, Bangalore. Stem cell cluster in Bangalore which will consist of IISc, NCBS, Manipal Hospital, CMC Vellore and a local company. Stem cell cluster in Hyderabad. Agribiotech cluster in Punjab. World-class undergraduate course in life sciences. Translational research institute at Gurgaon. However, Alok Gupta, country head, life sciences & biotechnology, YES Bank Ltd has different views on this. He said, "The cluster concept in India is still at a nascent stage. I personally feel an area can evolve as a meaningful cluster over a period of 10-15 years. It is premature to say when bioclusters like Research Triangle, Boston, Cambridge and the East England, San Francisco Bay will happen in India. Considering the present biotechnology industry growth in cities like Bangalore, Hyderabad, Pune, Chennai and Delhi, we can say that these cities will emerge as successful bioclusters. But one can see in all these cities one or the other missing factors like availability of capital and regular regional networking for free flow of information. If these things will be in place, then in next 5-10 years these cities will become one of the successful clusters in the world." Meanwhile the state and central governments have been taking many initiatives to support the biotechnology industry through developing biotech parks, policy initiatives, and announcing incentive packages. "There are some issues that are not in the hands of the governments towards cluster development. It will happen with the involvement and initiatives from all the stakeholders like the suppliers, the scientific community, venture capitalists, government agencies and organizations, individuals and regional networking associations," added Alok Gupta. Cluster formation is influenced by historical antecedents and the process of building on existing strengths. It takes many years to develop a cluster as factors like exploitation of the research base (covering a strong science base and entrepreneurial culture), company development (covering the ability to attract key staff, supportive physical and transport infrastructure, availability of finance, business support services and large companies, and a skilled workforce), and government support for cluster development (effective networks, and government support at regional and national level) are involved in it. Besides all these factors, there are other elements also which matter for the success of a cluster. International research has revealed a number of the most important success factors to support regional growth in biotechnology. The factors include strong government leadership, a strong bioscience research base, a strong entrepreneurial environment, a feeder layer of growing companies, clustering around research institutions and between companies, ability to attract key staff either through "natural" attractions or government facilitation, availability of venture capital or other finance, well-funded and accessible infrastructure, good formal and informal networks. Vibhav Garg, principal-business development, Mascon Life Sciences, said, "Bioclustering is a good way of looking at the scattered expertise and experience, which could be complementary to each other, under one roof. This approach is already bearing fruits for rest of the world." Vibhav Garg, principal-business development, Mascon Life Sciences, said, "Bioclustering is a good way of looking at the scattered expertise and experience, which could be complementary to each other, under one roof. This approach is already bearing fruits for rest of the world." Rajesh Jain, joint managing director, Panacea Biotec, said, "Bioclusters would work in India. Such bioclusters will be successful, provided a close interdisciplinary strategy is adopted by cohesive interactions between excellent innovative science and entrepreneur spirit of business leaders and industry-friendly policy of the government." And there is no shortcut for success. One has to wait to taste the fruits of success. According to Rajesh Jain of Panacea Biotec, pools of human capitals with capacity of fulfilling biotechnology technical and operational requirements are the fundamental building blocks for viable bioclusters. Locations that have national research center(s), universities and excellent medical hospital facilities would be ideal for business leaders to set up production and R&D ventures. Such locations may also have a set-up for bioservices facilities like top quality animal houses, pre-clinical testing of molecules and facilities to monitor clinical/field trials. Access to financial market and access to market and suppliers would be essential ingredients for a successful biocluster. The clusters may encompass broadly all disciplines of biotechnology. Considering the importance and benefits a cluster can provide, governments are working towards developing cities where potential and strength lies. At present they are still at the biotech center stage as rightly pointed out by Dr MK Bhan, secretary, Department of Biotechnology (DBT). With opportunities opening up in many areas like proteomics, genomics and drug discovery, India can look at developing specific clusters. On this, Vibhav Garg of Mascon Life Sciences said, "There should be a concerted effort to develop niche clusters like genomics, proteomics. Clusters in India can take shape based on the need or profile/expertise/complementarities. For example if a cluster namely "Drug Discovery and Design" is made, the organizations that understand this business area and are confident of offering the solutions in this field, can be kept in the cluster, while the companies looking for these services should be allowed to join the cluster as guest member." However, Rajesh Jain has different views on the need for developing niche clusters. He said, "Specialized areas like genomics and proteomics as clusters may not succeed as bio-venture because of lack of available innovative and talented scientific manpower and appropriate per se availability of markets for these disciplines. Such disciplines form part and parcel of modern era of biotechnology and biosciences. One may also consider the bioclusters models that exist across Europe and North America e.g., Cambridge, Oxford, Boston, or Ontario. These clusters have helped in tremendous growth of various start-ups." Approach towards cluster development As pointed out by the industry, governments can support and facilitate cluster development in a variety of ways. The governments can create the conditions that encourage the formation and growth of clusters. This can mean, for example, ensuring both national and regional policies do not inadvertently place barriers to cluster development, catalyzing the formation of social interactions and collaborations within a cluster, and ensuring research and innovation support programs build on existing strengths so as to work with the gain of cluster development. The regulatory and fiscal framework provides incentives that influence company formation and growth within clusters. Innovation and technology transfer support schemes can help to build on strengths. The programs initiated by the DBT like setting up of animal facility, stem cell center, incubation facilities and reengineering the existing institutions would help in the development of bioclusters in places like Bangalore, Hyderabad, Delhi and Punjab. Cluster Facts Clusters are a geographically proximate group of interconnected companies and associated institutions in a particular field, including product producers, service providers, suppliers, universities, and trade associations. Benefits of Clusters Raise innovation and productivity Help in sharing knowledge about best practices Reduce costs by jointly sourcing services and suppliers Interactions facilitate formal and informal knowledge transfer Encourage formation and efficiency of collaboration between institutions with comple mentary assets and skills Factors encouraging cluster development Strong science base: Leading research organizations, University departments, hospitals/medical schools and charities, critical mass of researchers, leading scientist(s). Entrepreneurial culture: Commercial awareness and entrepreneurship in universities and research institutes, role models and recognition of entrepreneurs, second generation entrepreneurs. Growing company base: Thriving spinout and start-up companies. More mature "role model" companies. Ability to attract key staff: Critical mass of employment opportunities, image/reputation as biotechnology cluster, attractive place to live. Premises and infrastructure: Incubators available close to research organizations. Premises with wet labs and flexible leasing arrangements, space to expand, good transport linksâ€“motorways, rail and international airport. Availability of finance: Venture capitalists, business angels. Business support services and large companies: Specialist business, legal, patent, recruitment, property advisors. Large companies in related sectors (healthcare, chemical, agrifood). Skilled workforce: Skilled workforce, training courses at all levels. Effective networking: Shared aspiration to be a cluster, regional trade associations, shared equipment and infrastructure, frequent collaborations Supportive policy environment: National and sectoral innovation support policies, proportionate fiscal and regulatory framework, support from regional development agencies and other economic development agencies, planning authorities. Source: Department of Trade and Industry, Government of the UK. Besides, the government can also play a role in catalyzing the development of networking activities and regional biotechnology organizations. This is a missing factor as far as India is concerned. A full-fledged cluster requires effective networks which allow a rapid flow of information and are able to engage the participation of all those with a stake in biotechnology. The success of a cluster depends on the extent and depth of interactions between constituent members. In India, we have organizations like the Association of Biotechnology Led Enterprises (ABLE), Association of Diagnostic Manufacturers of India (ADMI), Association of Contract Research Organizations (ACRO), Indian Society for Clinical Research (ISCR), All India Crop Biotechnology Associations (AICBA) and All India Biotech Association (AIBA) working for the growth of the biotechnology industry. Most of these are focused on specific sectors and few of them have regional chapters. We don't have regional associations on the lines of Eastern Region Biotechnology Initiative (ERBI) (Cambridge), Southern BioScience (Surrey), Oxfordshire BioLink (Oxford), BioScience York (York), or Scottish Enterprise activities (Scotland) that have been influential in fostering networking and facilitating a co-operative environment in the UK and in other countries like the US and Germany. Leading Life Sciences Clusters North America Seattle, USA San Francisco, USA Los Angeles, USA San Diego, USA Saskatoon, Canada Minneapolis/St. Paul, USA Austin, USA Toronto, Canada Montreal, Canada Boston, USA New York/New Jersey, USA Philadelphia, USA Baltimore/Washington, DC Research Triangle NC, USA South America Belo Horizonte/Rio de Janeiro Sao Paulo, Brazil Continental Europe Brussels, Belgium Medicon Valley, Denmark/Sweden Stockholm/Uppsala, Sweden Helsinki, Finland Paris, France Biovalley, France/Germany/ Switzerland BioAlps, France/Switzerland Sophia-Antipolis, France BioRhine, Germany BioTech Munich, Germany BioCon Valley, Germany United Kingdom/Ireland Glasgow-Edinburgh, Scotland Manchester-Liverpool, England Cambridge, SE England Dublin, Republic of Ireland Mid-East Israel Africa Capetown, South Africa Asia-Pacific Beijing, China Shanghai, China Hong Kong, China Tokyo-Kanto, Japan Kansai, Japan Hokkaido, Japan Taipei, Taiwan Hsinchu, Taiwan Singapore Dengkil, Malaysia New Delhi, India Hyderabad, India Bangalore, India Dunedin, New Zealand Australia Brisbane Sydney Melbourne Source: MBBNet (Minnesota Biomedical and Bioscience Network) Apart from regional networking associations, key individuals can also contribute a lot for the development of a cluster. In this regard Dr Swati Piramal of Nicholas Piramal initiated a move by launching "Maharashtra Bio Yatra" in Mumbai a couple of years back with the support of the Confederation of Indian Industry (CII). But there is no regular and much activity to mention. Conversely, in the absence of such a network and key individuals/ cluster champions, the level of interaction among the stakeholders of a cluster will be relatively modest or even nil. Hence the members of the cluster are often not aware of the local opportunities for premises, skills and complementary expertise. Feels Vibhav Garg, "Some nationalized agency (either public or private or co-operative) should take initiative to first design the clustering approach. Then cluster classification could be the next step followed by the individual organizations joining the cluster." As noted by Alok Gupta, clusters should be business driven and they should be formed due to a variety of reasons, e.g. specialized demand, prior existence of related industries or institutions, or historical antecedent. The quality of life and other non-economic factors can be equally important in determining growth. Clusters arise from making the most of synergies across and between companies and academic and research based institutions. Added Rajesh Jain, "The government has to take initiatives in terms of providing attractive concessions and designing a proper strategy keeping in mind the goals and priority of biocluster. It would be the first step to move forward. Biobusiness leaders have also to provide a firm commitment to set up bioventures in a biocluster." The government may consider launching special programs like biotech cluster innovative program, where R&D centers set up by the industry could be supported by providing competitive research grants with specific objectives tuned to economic development of the country and alleviate human sufferings. Sustainability of a start-up by appropriate financial assistance by government and financial institutes would be essential. The government and biobusiness leaders could set up business innovators incubator(s) jointly, so as to fine-tune the excellent leads generated by the scientific pools in the universities or research centers. The bioservices units that are set up in cluster should have appropriate accreditation. The fundamental bottlenecks would be unavailability of highly technical and qualified innovative scientific pool, inappropriate infrastructure and unavailability of financial assistance for early stage developments. Nevertheless, serious efforts in this direction would result in establishing bioclusters in the country. It is not only the government but also all the individual stakeholders such as suppliers, venture capitalists, universities, research organizations, service providers, networking associations and cluster champions who need to support the development of bioclusters in India. Narayan Kulkarni and Rolly Dureha ]]> <![CDATA[Market for LIMS opening up in India]]> https://biospectrumindia.com/news/95/4154/market-for-lims-opening-up-in-india.html https://biospectrumindia.com/news/95/4154/market-for-lims-opening-up-in-india.html Fri, 11 Nov 2005 14:08:00 +0530 Market for LIMS opening up in India Market for LIMS opening up in India With the new IPR regime in place, sponsors are looking at companies in India to outsource their work and this has opened up the market for LIMS tools. Laboratory Information Management Systems (LIMS) are the software tools that help automate the collection and management of the data generated in a laboratory. Many of these products let companies store data in commonly used databases, and they also interface with analysis equipment to collect experimental data. Effective use of information is a key task for every laboratory. Research and development laboratories need systems and procedures that can automate analytical processes and effectively share information. With the ability to make more real-time decisions, researchers can identify, and elevate promising candidate compounds to NDA, while eliminating non-viable candidates as early in the process as possible. LIMS systems that effectively serve pharmaceutical and life sciences research and development endeavors must offer a flexible set of features that adapt rapidly to changing workflows, materials and analyses. Configurable templates help to automate the workflows within the lab, including the creation of sample records, the assignment of testing and the collection of results, even in dynamic environments. Scenario In India LabVantge based out of Kolkata is a serious player in this space. Besides, Ocimum Biosolutions, Persistent Systems and Chennai-based Agaram Industries are offering LIMS products to companies from different markets like biotechnology/ bioagri, contract services, discovery, genomics, metabalomics, pharmaceutical/bio-pharmaceutical, pre-clinical/clinical, proteomics, quality assurance, quality control, quality management and research and development. Even multinational biosuppliers like Thermo Electron Corporation and Perkin-Elmer are also offering LIMS products. Key Features of LIMS Client/Server Based, Browser-Based, Simple User Interface, Sample Management, Extensive Sample Management Options, Flexible Reporting, True Adhoc Reporting, Analytical Quality Control, Trending, Robust Functionality, Configurability, Enhanced Configurability (Forms, Workflow, Data Model, Roles, etc), 21 CFR Part 11 Compliance with E-Signature and Fully Configurable Audit Trail, Configurable, Real-time Workflow Automation for Enforcing Your Business Processes, Instrument Integration Enterprise System and 3rd Party Application Interface Options, Specification Management, Extensive Specification Management, Extensive Inventory Management of ANY Entity (including Plates, Reagents, Tubes, etc), Stability and Shelf-life Analysis, Ability to Access System Via Any Internet-Ready Device (PC, PDA, Tablets, etc.), Configurable Multi-dimensional arrays (Racks of Tubes to Microtitre Plates to Gels to Chips), Ability to easily and seamlessly interface with your favorite Data Analysis and Mining tools, Complete Well and Plate Genealogy, Extensive Plate/Compound Management, Seamless Integration with Public/Private Databases. Headquartered at Kolkata, LabVantage's solutions support the LIMS requirements of general quality manufacturing, high-throughput discovery, and development laboratories. It offers three LIMS products to meet the needs of different types of laboratories. Its Sapphire R4 LIMS has solutions for the entire process - discovery, research and development, pre-clinical, clinical and quality management endeavors. LabVantage's Sapphire maintains a complete audit trail to comply with 21 CFR Part 11 and other FDA regulations. LabVantage's Sapphire LIMS offers a variety of mechanisms for grouping, tracking and viewing samples. Based at Hyderabad, Ocimum Biosolutions has three products in LIMS space. They are Toxchek, Pharmatracker and Biotracker. Toxchek is a pre-clinical LIMS that can manage, compare and track data from general toxicology studies like chronic, sub-chronic, acute, sub-acute, long-term and teratology studies. Pharmatracker is a multi-platform, multi-user, cost-effective LIMS especially suited for pharmaceutical industry. It enables R&D and manufacturing laboratories to perform QA/QC on all inventories, keep accurate track of samples, reagents, instruments, processes and output. Biotracker is a GLP and US FDA 21 CFR Part 11 compliant Laboratory Information and Knowledge Management System. Chennai-based Agaram introduced STARLIMS in India by establishing STARLIMS (AP) Centre of Excellence; offering services to implement, support STARLIMS clients in the AP region and Middle East. STARLIMS Corporation delivers cost effective, easy-to-use collaborative LIMS solutions to organizations in the public health, pharmaceutical, petrochemical, forensics, food & beverage, environmental and chemical industries. Pune-based Persistent Systems has LIMS tool that was designed to help automate the information flow part of the workflow. LIMS enabled the user to know his current jobs, information about the lab element they working on, tracking of information and so on. LIMS help manage the data in an integrated way and allow for the generation of reports. Thermo Electron Corporation provides a laboratory informatics solution, which includes comprehensive services for planning, implementing and supporting enterprise systems, with regulatory consulting, training, and system validation performed by a global professional services staff. Thermo's LIMS are designed to meet the flexibility demands of today's laboratories. Its LIMS offerings include; SampleManager, the world's de facto standard Enterprise LIMS, and Watson, the industry standard for bioanalytical labs at top 20 pharmaceutical companies. Anil Kastuar, president, LabVantage Solutions Pvt Ltd said, "The market for LIMS products is picking up. At present I feel the market is in the range of Rs 60-70 crore and biotechnology/ biopharmaceuticals sector contributes a lot to this. In my view the market for LIMS tools is growing at a healthy rate of 30-40 percent. But it is still in the early stages. In India we have a mix of people who know about LIMS but don't have idea about how it will help them or its applications." Anuradha Acharya, CEO, Ocimum Biosolutions said, "The LIMS market in India is just opening up. With IPR in place and some awareness about the regulatory issues, electronic submission of reports the companies are now looking at various tools including LIMS. It will take a couple of years to see growth in this new market." Commenting on the entry of Indian companies in the LIMS market, Anil Kastuar said, "They are diluting the market by introducing cheaper products/tools. Due to this, customers will end up in trouble after some time. One can see such situations in ERP, SAP market. We might face the same problem in LIMS market." On biosuppliers entry into LIMS space, he commented, "The customers have now become wise. They look at quality of the tool and not the brand. The biosuppliers who have range of products on offer to biopharmacetical and biotech companies do have an edge. This is only at the entry level." Anuradha Acharya said, "The problem in this market is some Indian companies are selling the tools at throw-away prices. It will create a bad impression. Moreover the companies have to understand the domain. Only then can they compete with MNCs.   Narayan Kulkarni     ]]> <![CDATA["Airlifting of infectious substances risky"]]> https://biospectrumindia.com/news/95/1323/airlifting-of-infectious-substances-risky.html https://biospectrumindia.com/news/95/1323/airlifting-of-infectious-substances-risky.html Fri, 11 Nov 2005 14:06:00 +0530 New Page 1 "Airlifting of infectious substances risky" Airlifting of infectious substances is not an easy task. It's a challenging and difficult game as infectious substances are those which are known or are reasonably expected to contain pathogens that are defined as micro-organisms including bacteria, viruses, rickettsiae, parasites, fungi and other agents such as prions and these pathogens can cause disease in humans and animals. "In air transportation of infectious substances, regulations (vary from region to region), permit requirements (differ from country to country) and customs (paper work discrepancies) still come in the way," said Ajit Pal Singh, operations manager, India, World Courier India Pvt Ltd. He was speaking at "Drug Discovery to Clinical Trials", an international conference organized by IBC in Mumbai. "There are solutions to overcome these problems. They include training through locally endorsed training provider and establishing a good partnership i.e. choosing the right courier company that matches one's needs. A courier company has to follow guidelines specified by different regulators," Singh stated. Infectious substances or dangerous goods are classified into nine categories namely explosives, gases, flammable liquids, flammable solids, oxidizing substances and organic peroxides, toxic infectious substances, radio active materials, corrosives and miscellaneous dangerous goods, of which some are again classified into divisions. BD Directigen EZ Flu A+B Test okayed BD Diagnostics, a segment of BD (Becton, Dickinson and Company), announced that the US Food and Drug Administration (FDA) has granted 510(k) clearance for the BD Directigen EZ Flu A+B Test. This two-step, rapid influenza test is able to clearly differentiate between influenza A and influenza B in fifteen minutes or less. The BD Directigen EZ Flu A+B test features two distinct windows on a single device to differentiate influenza A and influenza B with maximum efficiency. The test offers convenient room temperature storage. Commonly used oral medications, such as throat drops, nasal sprays and ibuprofen, have shown no interference with test results in analytical evaluations. It is compatible with multiple transport media, and has been validated for use with multiple specimen types. This saves laboratories the additional time and resources required to validate alternate transport media and specimen types. The release quoting Michael Towns, vice president, worldwide medical affairs, BD Diagnostics â€“ Diagnostic Systems stated, "Rapid diagnostics are extremely important in that they allow healthcare providers to rule out other respiratory infections, confirm a case of influenza, and select the appropriate treatment in a timely manner." PerkinElmer to focus on health sciences PerkinElmer announced its intention to divest the fluid sciences business segment to increase the strategic focus on its higher-growth health sciences and photonic markets. As part of the divestiture process, the company has signed a definitive agreement to sell its aerospace business to Eaton Corporation for approximately $333 million, subject to regulatory approval and customary closing conditions. The company also reported that it is in discussions to sell its semiconductor and fluid testing businesses. All of the planned divestitures are expected to be completed in the fourth quarter of 2005 with aggregate proceeds of approximately $400 million from the sale of the fluid sciences business segment. Health sciences markets include genetic screening, environmental, service, biopharma, and medical imaging. Photonics markets include sensors and specialty lighting. Oxford Immunotec, Millipore co-develop microtitre plates Millipore Corporation and Oxford Immunotec Ltd. will co-develop specially designed microtitre plate for use in clinical diagnostics kits. The new plate advances the simplicity, cost-effectiveness and performance of Oxford Immunotec's proprietary T-SPOT technology. Both the companies entered into this partnership in September 2004. At present, the plates are in production phase. Under the terms of the agreement, Oxford Immunotec has exclusive rights to use the plates for in vitro diagnostics with its T-SPOT assay kits. According to an official release, this is the first 8-well strip-based plate customized for use in Enzyme-Linked Immunospot (ELISPOT) methodology compared with typical 96-well plates. It is more economical for users to select the number of wells they require and reduce waste as a result. Utilizing Millipore's market-leading ELISPOT technology with Immobilon-P membrane, users can rely on the quality and accuracy of the product. Oxford Immunotec will incorporate the plate into a second generation of its T-SPOT.TB test kit. It is set to replace the 100-year old skin test currently used to diagnose this resurgent disease. Incorporating the new plate will provide greater flexibility and improved performance, while lowering the cost of administering the test. Innovative Biosensors, Cambrex establish manufacturing relationship Innovative Biosensors (IBI)and Cambrex Bio Science Walkersville, a subsidiary of Cambrex Corporation have signed an agreement for Cambrex to supply cGMP manufacturing services. IBI develops, manufactures, and markets pathogen tests for infectious diseases within the food safety and human clinical markets. Under the agreement, Cambrex Bio Science will provide cGMP (current Good Manufacturing Processes) production services for the manufacture of IBI's human clinical testing reagents. Production will take place in Cambrex's Walkersville, Maryland facility. "We are proud to be IBI's partner and believe that their technology has great potential. This is the first agreement where we will supply our cell-based cGMP manufacturing services, usually provided to therapeutic companies, to a client with innovative pathogen detection products. We believe our experience and infrastructure can help Innovative Biosensors jump start the product commercialization process," said Shawn Cavanagh, senior vice president and general manager, Cambrex Bioproducts. LaVision BioTec acquires sublicenses from Carl Zeiss The Microscopy Group of Carl Zeiss AG has granted the firm LaVision BioTec GmbH, Bielefeld, licences on several patents, retroactive to August 4, 2005. These patents protect the use of ultra-short laser pulses in the femtosecond range for multiphoton fluorescence excitation in laser scanning microscopy. The company had acquired the exclusive global rights to this method, including the entitlement to grant sublicenses from the Cornell Foundation, Ithaka, USA, in 2004. After the granting of the sublicenses, LaVision BioTec is currently the world's only manufacturer, apart form Carl Zeiss, which is permitted to offer fs-multiphoton microscopes. Carl Zeiss uses this specimen-protecting technology, which enables a particularly high depth of penetration in the examined object, to generate maximum resolution 3D images in its LSM 510 Laser Scanning Microscopes. La Vision BioTec also operates in the field of laser scanning microscopy and uses this technique for its TriM Scope multifocal 2-photon microscope. Sartorius acquires Omnimark Sartorius has acquired a 100 percent stake in Omnimark Instrument Corporation based in Tempe, Arizona, USA. Omnimark distributes special moisture analyzers for quality assurance in the chemical and food industries. The acquisition process was completed on October 1, 2005, according to a press release. Founded in 1991, the company has been owned so far by a family as the major shareholder, and has become the market leader in the premium moisture analyzer segment in North America. For years, Omnimark has been supplying its customers with Sartorius moisture analysis equipment and has been also offering sophisticated, application-related services in moisture determination. In 2004, the company earned approximately $3 million in sales revenue. Dr Joachim Kreuzburg, Sartorius Group CEO, assessed this takeover as a relatively small acquisition, which can be quickly integrated into the Sartorius Group, yet is of strategic significance. "Omnimark has an excellent customer base, a high level of applications expertise and a successful direct sales policy. This acquisition strengthens our presence in one of our most important regional target markets and, at the same time, with several of our major customer groups. The objective behind this acquisition is to make Omnimark products and services available on our global Sartorius sales platform," he said. Biotron Healthcare signs pact with CDRI Mumbai-based Biotron Healthcare (India) Pvt. Ltd, has signed a licensing agreement with Lucknow-based Central Drug Research Institute (CDRI), a leading institute in India for manufacture of classical PCR and Real Time PCR kit for tuberculosis. The technology transfer holds significance in the light of the WHO report which states that nearly two billion people are infected by tuberculosis bacilli and eight million people worldwide develop active TB and three million people die annually due to this disease. Venkatesh Voleti, director â€“ sales, Biotron Healthcare said, "The kit will be priced in the range of Rs 500-600. We plan to contact physicians and clinical labs all over the country so as to reach rural people. Adequate training will be provided to the people to achieve good results." Praj bags Ethanol plant contract from Turkey Praj Industries, a Pune-based company has bagged an ethanol plant contract from Konya Seker, Turkey against stiff competition from European players. Praj confirmed that the award of contract was worth Rs 36 crore for a 280,000 litres per day bioethanol plant. The project is being set up for production of bioethanol using sugarbeet molasses/syrup as feedstock. The project is expected to become operational by November 2006. Turkey is expected to formally announce its fuel ethanol program in January 2007. Pramod Chaudhari, chairman, Praj said, "This is a major milestone for Praj paving the way to the European markets where fuel ethanol programmes mandates are being introduced. This order has been bagged by our Sharjah office set up a year ago. The office has already achieved success with bagging of an order from Algeria as well as this order from Turkey". NI comes with a new class of PACs To address the growing needs of machine and industrial control system, National Instruments (NI) has created a new class of industrial controllers known as Programmable Automation Controllers (PACs). These industrial grade controllers combine capabilities for logic control, process control, machine vision, and I/O integration â€“ all using a single software environment. The PACs have unique advantages that help organizations achieve savings in terms of manufacturing time, increased productivity and enhanced savings. This is accomplished because of NI's LabVIEW. By simply being familiar with LabVIEW use, engineers are able to address applications involving high-speed control, data acquisition, machine vision based inspection, custom motion control, advanced analysis and reporting, etc. According to Jayaram Pillai, country head, NI Systems India, "The advancement in automation technologies will bring great benefits to the manufacturing process and the industry itself. In the Indian market context, given the competitiveness of brands that operate on small margins and large volumes, PACs are more relevant due to the immense benefits they offer." Using PAC technology, enterprises can easily address Advanced Automation applications while availing huge productivity improvements, and long term cost benefits. They can also future proof their investments by allowing them to cope with future system changes/requirements in terms of additional functionality or capabilities.   ]]> <![CDATA["Indian life sciences market is growing phenomenally"]]> https://biospectrumindia.com/news/95/1675/indian-life-sciences-market-is-growing-phenomenally.html https://biospectrumindia.com/news/95/1675/indian-life-sciences-market-is-growing-phenomenally.html Fri, 11 Nov 2005 14:04:00 +0530 New Page 1 "Indian life sciences market is growing phenomenally" VS Upadhye, CEO, Labindia Instruments shares his vision on the future of the company. What is the positioning of Labindia amongst the Indian biosuppliers? How is the company planning to consolidate and expand its presence in the life sciences space? Labindia is a fairly old biosupplier in the country and is the exclusive partner for Applied BioSystems (ABI) in India. It is expanding at a very rapid rate as the life sciences market itself is growing phenomenally. Last year we became the largest supplier in the biotech arena in the country, according to the BioSpectrum-ABLE industry survey 2005. Our core competency is in the areas of LC MS/MS, DNA sequencing, PCR and RT PCR. Till date, in India, we have an installation base of 220 LCMS/MS instruments. On an average we install about 100 LCMS/MS instruments in a year. A large number of them are used in pharma and bioequivalence studies and also in food and quality testing. We not only supply the equipment but also join hands and team up with our users by offering maintenance service and support to obtain highest quality and accurate results. We do have plans for future expansion and it will happen in two directions, with Applied Biosystems as a supplier and also beyond the purview of Applied Biosystems. What is your long-term vision for the company? We are thinking of expanding into the software-testing domain. Currently we are working in this area but on a limited scale, like testing the LCMS/MS software for MDS Sciex, who manufacture the LC MS/MS systems, imaging software for Leica. We are also holding talks with a few world leaders for the writing and testing of their software for applied markets like human identification (DNA fingerprinting), pathogen testing in food and agri segment and pharma quality testing. Another area in which we are foraying is the CRO space. We set up CliniSearch about six months back and this group company of ours focuses on clinical trials, pharmacogenomics, bio-equivalence studies and microarray services. In the long run our focus will be on international tie-ups in Europe and the US with a view to extend our services to these countries. We have also started a company in Dubai, which will be operating both in the bio and analytical space. Its core focus will be on export of instruments and services. Initially our focus will be on the gulf countries but later we plan to expand our reach to Europe and the US. To achieve our long-term goals, we want to capitalize on our strengths as a biosupplier and then enter into collaborative manufacturing. We are planning to foray into this sector in the next six months. We are looking into the collaborative manufacturing of bio-reagents, chemicals and instruments and software. At present we are talking to a government institute for the technology transfer of certain profiling kits. We have also initiated some R&D activities, in association with Aba Saheb Garware College, Pune, where we are working on a project on bacterial identification. Here we are isolating, culturing and sequencing the undocumented bacteria and developing a database. In addition to the DNA profiles of the bacteria, we are also maintaining cultures as well. We have also signed a MoU with the Delhi University, South Campus on neonatal screening. We will set up the required infrastructure at the biotech park located in South Campus and will receive the neonatal samples from all the government hospitals in Delhi. We will then screen the samples for 5-6 neonatal diseases like congenital hypothyroidism and G6PD with the help of kits/diagnostics using the available techniques. This will essentially be a "not for profit" project for at least the next three years as the money generated will be invested back into research. How is Labindia's array facility being received by the life sciences industry? The Labindia Microarray Service Facility utilizing ABI expression array system was started in the middle of this year. Though it had a slow start in the beginning, it has now picked up. The scientific community has shown keen interest and we have been getting regular enquiries. Currently on an average we receive 4-8 samples in a month. We anticipate that the facility will pick up in a big way very soon and by March 2006, I am expecting that it will be running in full swing. After our initial experience, we are in a position and planning to expand our array operations beyond India. How do you see life sciences solution providers evolving in the future? In the biosuppliers segment, the things as they stand now, point towards a bright future. The field of sequencing would grow rapidly. After the whole genome sequencing, the emphasis would now be on the detection of specific mutations. Sequence-based screening or re-sequencing as it is called will assume importance. Real Time based diagnostic is also a fast growing area. Applied markets like DNA fingerprinting, agriculture testing like GMO, food quality testing including tests for pathogens and diagnostic will give a lot of scope for many suppliers to grow rapidly in this direction. Luckily India boasts a strong pharma industry in the country, which is doing very well. This gives many opportunities to biosuppliers to grow fast in this space. Rolly Dureha "Time ripe to bring our offerings to the Indian market" Ian Tarr, executive vice president, pharma and chemical markets, Thomson Pharma who established a new line of drug information publications and databases targeted at the pharmaceutical R&D sector at Current Science Group in 1990, was recently in Mumbai to participate in an international conference, "Drug Discovery to Clinical Trials". In an exclusive interview to BioSpectrum, he speaks about the services offered by Thomson Pharma to life sciences and biotech companies. Excerpts. What are the services you offer to life sciences companies in general and biotech companies in particular? Traditionally we had a range of different products for pharmaceutical companies that were developed by different companies and acquired by Thomson in the last three to four years. There are some post-published products lines in patent area with leading patent services and current content Thomson had got in the 1960s. And we also have Literature Monitoring Services, Current Content Connect and Web of Science. More recently in the acquisitions we made, we moved into discovery research by acquiring Current Drugs, a leading name in the area of monitoring happenings in drug research. With number of other acquisitions in different areas, we have ended up with a portfolio of products. In the last one year, we brought all these products under one offering or solutions called Thomson Pharma. How do you look at the opportunity for your services in India and the rest of the world, specifically the Asia Pacific region? We have been offering our services to all leading pharmaceutical and biotech companies in Europe, the US and Japan. We are also using it as a means to reach out to all the new companies and small start-up companies and service organizations. We run our business in the Asia Pacific region from Japan and Singapore. We used to support the Indian business from these two centers. Now we are developing our center in India. We are now bringing a new approach to India where we already have some presence through our old products particularly in the patent side such as Delphion, an easy-to-use solution offering business and professional researchers full-text patent documents as well as powerful search technology and value-add analysis and productivity tools. We have just appointed a person dedicated to marketing of the products, who will work with the national manager â€“ Thomson Scientific based out of Bangalore. By June 2006, we will be supplementing those people with additional training and support services as well. Considering the growth in biotechnology and pharmaceutical industries in India, we feel now is the time to bring our offerings to the Indian market. Currently we are looking at investing a lot in building the sales and marketing training resources in the country. In India we have five direct sales force and two agents. Who will be your customers in India? All traditional pharmaceutical companies will be using one or the other product of Thomson Pharma. The new product offering will allow the companies very easily to get the breadth of information particularly on drug discovery research and development. A lot more scientific information is required. Our strength lies in supporting these activities. Since our products are all integrated together, the need to learn and train on several other different products will be minimized and barriers to entry will be reduced. So we feel small biotech companies will adopt it very quickly as a useful fleet of information services. By this they can get quick support information and they don't have to depend on luxury of a separate information service department. It is a cost effective way to get a broad range of information to support their research activities. Cost is a key factor for small biotech companies that are active in research and development. What pricing model have you adopted for Indian companies? We have many small biotech companies on our list. We have a flexible pricing model for them. To start with, we offer low entry price. The price will increase based on the usage from 100â€“1000 depending on the size of the company. It is scalable pricing. We haven't faced pricing as a barrier for entry. Recently to accommodate a couple of very small biotech companies with handful of people, we adopted a consortium-pricing model. If there is a group of biotech companies in one area, they can form a consortium to buy our products. We wish to grow with our clients. We don't want price to be a barrier for our customers. We don't have any specific or fixed entry-level price for our services. It will be based on different aspects including the needs of the company, usage and areas of focus. Narayan Kulkarni ]]> <![CDATA[Indigenous Biopesticide takes on agricultural pests]]> https://biospectrumindia.com/news/95/5824/indigenous-biopesticide-takes-on-agricultural-pests.html https://biospectrumindia.com/news/95/5824/indigenous-biopesticide-takes-on-agricultural-pests.html Fri, 11 Nov 2005 14:02:00 +0530 Indigenous Biopesticide takes on agricultural pests Indigenous Biopesticide takes on agricultural pests ICGEB scientists have developed "Bioprahar", a microbe-based biopesticidal formulation effective against a range of pests of agronomic importance. Scientists at the New Delhibased International Centre for Genetic Engineering and Biotechnology (ICGEB) have developed a bacterial formulation for the control of a range of agricultural pests. Named as "Bioprahar", the formulation is being commercially launched by Nirmal OrganoBiotech Ltd, its industry partner, in 2005. The formulation has been found effective in controlling diamond-back moth in cabbage and cauliflower; white woolly aphids in sugarcane; mealy bugs in grapes, citrus and mango; and white ants in teak plantations. The active ingredient of the biopesticide formulation developed by ICGEB is Photorhabdus luminescens sub sp. akhurstii, a bacterium, which resides in the intestinal tract of nematode Heterorhabditis indica. This bacterium secretes several extracellular macromolecules, which are lethal to pests. Due to their mutualistic association with Photorhabdus bacteria, nematodes of the genus Heterorhabditis are well known parasites against insect pests. They are commonly used in pest management programs to control soil borne pests. The modus operandi of this symbiotic pair is that on entering the insect, Photorhabdus is released into the host gut where they multiply rapidly and kill the insect. They also degrade the insect upon which the nematodes feed and multiply. Taking this lead forward, scientists (Dr Raj Bhatnagar and Dr Raman Rajagopal) of the Insect Resistance Group at ICGEB, isolated and characterized the bacterium strain from a Heterorhabditis nematode species prevalent in the southern part of India and evaluated its efficacy against several pests. In parallel, the researchers purified and studied the insecticidal toxin complex produced by the bacterium. Their studies showed that this complex is lethal to pests and is responsible for the death of the insect. After having finished this groundwork, came the tricky task of making an effective formulation. Speaking about this uphill task, Dr Bhatnagar said, "The biggest challenge was to make a viable formulation, which does not require a cold chain. Though initial studies showed good results, application in the open fields remained a challenge. We prepared a liquid formulation consisting of the bacterium and the growth medium, but its shelf life was very short. The formulation was then further fine-tuned and stabilized with emulsifiers and stabilizers so that it remains biologically active for a longer duration". "Presently the biopesticide formulation consists of the bacterium, surfactants and adjuvants. Its shelf life is over a year with no drop in the potency or efficacy of the formulation," he added. The field tests were conducted in agriculture fields together with Dr NGV Rao at Punjabrao Deshmukh Krishi Vidhalaya (PDKV), Akola against the diamond-back moth pest of cauliflower and cabbage; Vasant Dada Sugar Institute, Pune against the white wooly aphids of sugarcane; and the fields of commercial alliance partner Nirmal Biotech against mealy bugs of grapes, mangoes and citrus. A specific regimen of spraying on each crop was developed and the results obtained after two growing seasons revealed excellent control of the targeted pests. Overall the efficacy of the formulation was comparable to any chemical pesticide. Significantly the application of chemical pesticides in protection of cabbage and cauliflower from pests is second to cotton. It has been shown that "Bioprahar" effectively controls these pests and will thus reduce usage of chemical pesticides in these crops to a large extent. Similarly, sugarcane production in India has suffered immensely during the last couple of years due to the white wooly aphids. "Our field evaluation data, at six districts in Maharashtra revealed effective control of white wooly aphids. This formulation will minimize the problems faced by sugarcane farmers because of wooly aphids. Nearly 90 percent control of the white wooly aphids was seen in sugarcane fields," explained Dr Bhatnagar. The effective control of mealy bug in the case of citrus, grape and mango is expected to promote organic farming paradigm and make the production export competent. In addition, the biopesticide displayed excellent control of termites. It was found that the whole colony of white ants collapsed in 24-48 hours. Simultaneous evaluation of mammalian toxicity at two different independent laboratories, PDKV, Akola and National Toxicology Centre, Pune, demonstrated the safety of formulation based on standard tests. The formulation did not show any allergenicity, toxicity or any other side effects against rabbit, mice or rats. The patent for "Bioprahar" and "Biowooly Kill", a related formulation for white wooly aphids, has been filed in India and PCT countries in 2004. Rolly Dureha Personal genome sequencing possible for $1000 soon A step toward the $1,000 personal genome using readily available lab equipment The theoretical price of having one's personal genome sequenced has fallen from the prohibitive $20 million dollars to about $2.2 million, and the goal is to reduce the amount further to about $1,000 to make individualized prevention and treatment realistic. The sharp drop is due to a new DNA sequencing technology developed by Harvard Medical School (HMS) researchers Jay Shendure, Gregory Porreca, George Church, and their colleagues. Their findings have been reported on August 4 in the online edition of Science. The team sequenced the E. coli bacterial genome at a fraction of the cost of conventional sequencing using off-the-shelf instruments and chemical reagents. The Church group's technology is based on converting a widely available and relatively inexpensive microscope with a digital camera for use in a rapid automated sequencing process that does not involve the much slower electrophoresis, a mainstay of the conventional Sanger sequencing method. "Meeting the challenge of the $1,000 human genome requires a significant paradigm shift in our underlying approach to the DNA polymer," write the Harvard scientists. The new technique calls for replicating thousands of DNA fragments attached to one-micron beads, allowing for high signal density in a small area that is still large enough to be resolved through inexpensive optics. One of four fluorescent dyes corresponding to the four DNA bases binds at a specific location on the genetic sequence, depending on which DNA base is present. The fragment then shines with one of the four colors, revealing the identity of the base. Recording the color data from multiple passes over the same sequences, a camera documents the results and routes them to computers that reinterpret the data as a linear sequence of base pairs. In their study, the researchers matched the sequence information against a reference genome, finding genetic variation in the bacterial DNA that had evolved in the lab. "These developments give the feeling that improvements are coming very quickly," said HMS professor of genetics, Church, who also heads the Lipper Center for Computational Genetics, MIT-Harvard DOE Genomes to Life Center, and the National Institutes of Health (NIH) Center for Excellence in Genomic Science. "The cost of $1,000 for a human genome should allow prioritization of detailed diagnostics and therapeutics, as is already happening with cancer," Church said. Source: Harvard Medical School DNA buckyballs for drug delivery Researchers at the Cornell University have made DNA buckyballs - tiny geodesic spheres that could be used for drug delivery and as containers for chemical reactions. The researchers are making buckyballs out of a specially prepared, branched DNA-polystyrene hybrid. The hybrid molecules spontaneously self-assemble into hollow balls about 400 nanometers (nm) in diameter. The DNA/polystyrene "rods" forming the structure are each about 15 nm long. About 70 percent of the volume of the DNA buckyball is hollow and the open spaces in the structure allow water to enter. Dan Luo, Cornell assistant professor of biological and environmental engineering in whose lab the DNA structures were made, suggested that drugs could be encapsulated in buckyballs to be carried into cells, where natural enzymes would break down the DNA, releasing the drug. "They might also be used as cages to study chemical reactions on the nanoscale," he said. The nanoscale, hollow buckyballs are also the first structures assembled from "dendrimer like DNA." If three strands of artificial DNA are created such that portions of each strand are complementary to portions of another, the three strands will bind to each other over the complementary portions, creating a Y-shaped molecule. By joining several Ys in the same way, Luo's research group created molecules with several arms, a sort of tree shape (dendri- means tree in Greek). Then they attached polystyrene molecules to the dendrimerlike DNA forming a hybrid molecule called an amphiphile - a molecule that both likes and hates water. DNA is hydrophillic - attracted to water - while polystyrene is hydrophobic - water repels it. The researchers expected the amphiphiles to assemble in water into some sort of solid structure arranged so that DNA would have a maximum interaction with water and polystyrene would avoid water as much as possible. Other researchers have used other amphiphiles to make spheres, rods and other solids. The hollow buckyballs were an intriguing and serendipitous surprise. A model suggests that one buckyball consists of about 19,000 amphiphiles, with their water-loving DNA mostly on the outside of the rods that form the structure. How these tens of thousands of molecules were able to self-organize to form such an intricate and complex structure is still an open question, the researchers say. They are seeking collaborators to solve the puzzle. Source: Cornell University   ]]> <![CDATA[Thermo]]> https://biospectrumindia.com/news/95/4720/thermo.html https://biospectrumindia.com/news/95/4720/thermo.html Fri, 11 Nov 2005 14:00:00 +0530 Thermo Thermo's high-performance spectrophotometer Thermo Electron Corporation has introduced its new Evolution 600 UV-Vis spectrophotometer designed for excellent performance and flexibility in material science, life science and general research analyses. It is capable of analyzing virtually any sample such as optical components, thin film, glass and plastics regardless of shape, size or composition enabling analysis of samples not previously possible by instruments in this price range. It offers a wide breadth of new, sophisticated accessories for analyzing solid samples including a Diffuse Reflectance accessory, a VN Absolute Specular Reflectance accessory and a Solid Sampling accessory. In addition, this instrument features enhanced performance specifications including improvements in dynamic range, resolution, wavelength accuracy and photometric noise. Evolution 600 is equipped with the VISIONpro software, which has been significantly improved to suit the analytical needs of material science and life science markets. VISIONpro is a flexible software package designed for the general research and QC laboratory. VISIONlife adds the ability to monitor and calculate reaction kinetics and to perform DNA melting experiments. A Smart Accessory feature provides auto recognition, smart alignment and serial number identification for ease of use and increased productivity. For details, contact: shahin.shah@thermo.com Sigma-Aldrich's functional cancer protein microarray Sigma-Aldrich has launched Panorama Human Cancer Version 1 Protein Functional Microarray. Developed by Procognia Ltd, the UK and licensed exclusively through Sigma-Aldrich, the Cancer V1 protein microarray contains 130 correctly folded proteins. These proteins are selected from a recent seminal scientific publication that reviewed and compiled all proteins that are implicated in mediating cancer. This is a new addition to the Sigma-Aldrich microarray product line. This product extends Sigma's market-leading array portfolio for proteomics research including arrays of proteins, antibodies, peptides and tissue extracts. For more information: smohamed@sial.com Millipore introduces SHR filters Millipore has announced the availability of its new Millipore Express SHR (Sterile High-Retention) filters providing sterilizing-grade performance and mycoplasma removal across a range of applications including cell culture media and media additives, process intermediates and other biological fluids. These filters deliver validated sterilizing-grade filtration and reliable mycoplasma removal for enhanced sterility assurance, high flow rates for improved process efficiency and an on-board PES membrane prefilter for extended filter capacity and lower filtration costs. The sterilizing-grade Millipore Express SHR 0.1-µm rated filters are available in a range of formats including: membrane disks (25 mm, 47 mm, 90 mm and 142 mm); cartridge filters ranging in size from 5- to 30-inches; OptiScale disposable scaling devices; and Opticap XL and XLT autoclavable or gamma-compatible capsules. For more information, contact: rajiv_juneja@milliporeindia.com HiAirFlow air sampler from Himedia Laboratories Mumbai-based Himedia Laboratories has developed HiAirflow for monitoring of air bio contamination level in critical places (e.g.: clean rooms, food plants, fermentation's plants, etc.). The equipment conforms to the new European ISO/TC 209 dated July 25, 1999 recommendations. HiAirflow allows collection of a wide range of airborne biocontaminant by impacting on agar standard plates (90 mm diameter, filled with every kind of culture media). HiAirflow can be used successfully in a wide range of applications (air quality control in pharmaceutical, food, cosmetics plants, in hospitals, clinics and laboratories) for sterile or non-sterile areas monitoring. It is very useful also for air monitoring in building air conditioning (HVAC) plants. For details, contact: Info@himedialabs.com, vwarke@himedialabs.com ]]> <![CDATA[Kariath quits Sartorius]]> https://biospectrumindia.com/news/95/5895/kariath-quits-sartorius.html https://biospectrumindia.com/news/95/5895/kariath-quits-sartorius.html Fri, 11 Nov 2005 13:57:00 +0530 Kariath quits Sartorius Kariath quits Sartorius Anil Paul Kariath, managing director, Sartorius India Pvt Ltd has quit the company to start a new venture. Kariath is launching BioZEEN (a division of Bangalore Biotech Labs Pvt Ltd), a specialized institution to bridge the gap between academia and industry. "At BioZEEN a cGMP compliant biopharmaceutical plant has been set up to impart training in an industry environment. BioZEEN is equipped with all process equipment used in the biopharma industry. The students will be provided hands-on training in animal cell culture, media production, microbial fermentation, downstream processing, etc. Students with engineering backgrounds will be trained in designing of bioreactors, process vessels and tangential flow filtration systems. In addition, they will be trained in automation and plant utility engineering. Training in validation of process plants is a part of the curriculum too," informed Kariath. The training courses have been designed in a modular fashion of one month. "A year's training course here will be equivalent to five years of industry exposure. Industry personnel can also join for any module in which they intend to specialize at any time," he added. This course is understood to be the first of its kind in the private sector and the center has been set up with an investment of about $3 million on a 10-acre campus in Bangalore. The courses will begin in the first quarter of 2006. A bioprocess specialist in designing vaccine plants, biopharma plant engineering, equipment design, and validation, he built Sartorius India as a leading bioengineering company in the country. Kariath moved to Sartorius India in 1997 after a successful career in vaccine production at Indian Immunologicals Ltd. Kumud Sampath joins US Pharmacopeia Kumud Sampath has joined US Pharmacopeia (USP) as general manager of its India site in Hyderabad. Sampath will be leading and managing USP's subsidiary in India. Her priorities would be to establish and build strong relationships with customers, government officials, professional and trade associations, and promote the Indian site and USP's overall global public health goals. Sampath was previously president and executive director of AstraZeneca India (Pvt) Ltd. Prior to that she was vice president of business development and operations for Astra Biochemicals Pvt Ltd. She has also been the chair of the South Zonal Export Promotion Council, a member of the Biotechnology Vision Group (Karnataka), and a member of the governing board of the Karnataka Biotechnology Development Council. Sampath earned her master's in business administration from the University of Delhi and participated in the International Management Development program in Lausanne, Switzerland. Legion of Honour for Prof. Goverdhan Mehta The Government of France has conferred "Chevalier de la Legion d'Honneur" (Knight of the Legion of Honour) on Prof. Goverdhan Mehta, former director, IISc and presently an honorary professor at the institute. Prof. Mehta's association with France which began in 1991 as a visiting professor in Grenoble, spans over a decade during which Indo-French scientific collaboration reached a new high. During his tenure as director of the Indian Institute of Science (IISc), the Indo-French Cyber-University (FICUS) based on high-tech satellite technology, was set up between IISc and Toulouse while several projects in Prof. Mehta's area of specialization-organic synthesis and solid state chemistry were initiated. On a global scale, Prof. Mehta's contribution towards promotion of science in third world countries as a member of 'Third World Academy of Science' is noteworthy. Recipient of several awards such as the Padma Shri in 2001, the CV Raman Medal in 2003, the GD Birla and Pandit Nehru National Award for Excellence in Science in 1992 and 1994 respectively, an editorial board member of nine scientific journals and a Doctor Honoris causa of several prestigious French universities, Dr Mehta started his brilliant career as a professor at the Hyderabad University, became director of the IISc, Bangalore and later was appointed CSIR Bhatnagar fellow by the Government of India. Prof Padmanaban receives GM Modi award The Gujar Mal Modi Science Foundation has awarded Prof. G Padmanaban, eminent biotechnologist, the prestigious "Gujar Mal Modi Award for Innovative Science & Technology" for the year 2005. Prof Padmanaban, former director and now a distinguished biotechnologist at the IISc, Bangalore, is acclaimed for his work in the area of recombinant DNA technology and malaria research. His contribution in research related to generation of modern vaccine initiatives against different infectious diseases is well recognized in India and the rest of the world. Dr Padmanaban is presently working on new drugs for malaria, which are expected to be an economical alternative to combat this poor man's disease. "India becoming a hub of vaccinology" â€“Prof G Padmanaban speaks about malarial research and his vision for India. What are the latest developments in malarial research? In malaria research two significant things are happening in our laboratory. One is that we are looking at the heme pathway, which is vital for the parasite survival. We have cloned all the genes in the pathway. And if some strategic steps of the pathway are knocked out, the parasite should die. Secondly, we have found that a combination with curcumin is completely protective against malaria in animals. We have tested our curcumin combination on a mouse model. We are now talking to the DBT and ICMR for doing clinical trials studies in humans. The challenge is definitely to develop a new drug. What is your vision for India in the area of vaccines? India should definitely become a hub of vaccinology, and I can see signs of that happening already. We should concentrate on vaccines and biopharmaceuticals. At this juncture, there are three diseases for which India alone does not have the competency to develop vaccines. These diseases are malaria, tuberculosis and HIV. There has to be an international effort to develop vaccines against these diseases, and India should be a significant part of this effort. Rolly Dureha ]]> <![CDATA[IICT develops process for biopesticide formulations]]> https://biospectrumindia.com/news/95/2229/iict-develops-process-for-biopesticide-formulations.html https://biospectrumindia.com/news/95/2229/iict-develops-process-for-biopesticide-formulations.html Fri, 11 Nov 2005 13:56:00 +0530 IICT develops process for biopesticide formulations IICT develops process for biopesticide formulations The Indian Institute of Chemical Technology (IICT), Hyderabad, has developed a process for biopesticide formulation (10,000 ppm) from the seeds of custard apple and karanja and recently transferred the technology to a small-scale industry unit, Sri Biotech, Hyderabad. The formulations prepared from the extract of the seeds of custard apple and karanja are effective in controlling the insect pests of several crops and are not phytotoxic. These biopesticides are eco-friendly, safe and biodegradable. IICT has demonstrated the process on 1 kg batch of feedstock of seeds of custard apple and karanja. The process technology is available for other interested entrepreneurs for transfer and could be implemented at small-scale industry level where seeds of custard apple and karanja are available locally. IBAB holds workshop on IPR The Institute of Bioinformatics and Applied Biotechnology (IBAB) conducted a three-day workshop on Intellectual Property Rights in collaboration with Brain League consultants, from October 19-21, 2005. The purpose of the course was to provide an understanding of basic concepts of IP relating to technology, to give an insight into IP management, licensing, valuation, and other aspects of IP and to teach basic skills necessary for a good IPR protection system within the company. Kalyan C Kankala, LLM in Intellectual Property, Commerce and Technology, Franklin Pierce Law Center Concord, conducted most of the sessions. Strand, Elan sign pact Strand Life Sciences has entered into a research collaboration with Elan Pharmaceuticals aimed towards supporting Elan's drug discovery efforts. This collaboration allows Elan to access Strand's technologies and achieve customized solutions for internal research programs. The agreement incorporates access to Strand's extensive in silico technology portfolio including predictive modeling for efficacy and ADMET, custom library design, QSAR and pharmacophore modeling, structure based drug design, data and visual mining and consulting experience. "We are very excited about this opportunity and are confident that this will be a mutually beneficial relationship," said Kas Subramanian, chief scientific officer, Strand Life Sciences. BII introduces innovative teaching methodologies Bioinformatics Institute of India (BII), a bioinformatics and biotech institute, has introduced new techniques and teaching methodologies to enhance the quality of education. Recently, Harvard University approached BII for recommending its students for Post-Doctoral Positions in Bio-Informatics available at Harvard University. Vijay Shukla, director, BII commented, "BII is perhaps the only academic organization in the country which is utilizing these novel hi-tech methods in its regular curriculum. It is a matter of great prestige that the world's top most university has recognized the quality of students produced by BII and offered an opportunity to refer students." Nicholas Piramal acquires Avecia Pharmaceuticals Nicholas Piramal has announced the acquisition of the UK-based Avecia Pharmaceuticals for a consideration of £9.5 million. The consideration is inclusive of funding the business' UK pension fund deficit of between £8-9 million. The transaction completion is subject to required regulatory and other approvals. This acquisition is the company's second M&A transaction in the UK after the acquisition of Rhodia's Inhalation Anaesthetics business in December 2004. Ranbaxy signs pact with Lupin Lupin and Ranbaxy Laboratories have entered into a licensing agreement as per which Ranbaxy will market Lupin's Tuberculosis brand in the severely affected West and North African markets. The alliance will leverage the combined strengths. As per the arrangement, Ranbaxy will sell Lupin's TB brand "Akurit", a fixed dose combination, in countries such as Nigeria, Ghana, Ivory Coast, Cameroon, Algeria, Chad, Mauritania and Congo. Biotracker achieves GeneChip-compatible status Ocimum's Biotracker has achieved GeneChip-compatible status with the Affymetrix GeneChip microarray platform and will participate in the Affymetrix GeneChip-compatible Applications Program. The program provides customers with a broad spectrum of software solutions for biomedical research and development. Ocimum's Biotracker is a GLP and US FDA 21 CFR Part 11 compliant Laboratory Information and Knowledge Management System. It is a tool for improving laboratory performance. AstraZeneca, NPIL sign pact AstraZeneca AB, Sweden and Nicholas Piramal India Ltd (NPIL) have announced the signing of a development and know-how agreement. Under this agreement, both the companies will establish a framework for future collaboration for development of processes for the manufacture of intermediates, active ingredients or bulk drugs for supply to AstraZeneca. The development and know-how agreement does not have a fixed tenure. It is envisaged to continue and last so long as the parties have products under development. If the collaboration on any of the product development is successful, the agreement provides for the parties to further negotiate terms of an agreement for supply of the product by NPIL to AstraZeneca. Sterling Biotech acquires Torrent Gujarat's biotech facility Sterling Biotech, one of the largest manufacturers of pharmaceutical gelatin, has announced Rs 55 crore deal to acquire the manufacturing facility of Torrent Gujarat Biotech. The plant of Torrent Gujarat Biotech is located at Masar in Baroda. The transaction is subject to both the parties receiving necessary approvals under applicable laws. Sterling Biotech will use the facility to manufacture specialized gelatins derivatives such as fish gelatin, hydrolyzed gelatin and fermentation-based neutraceuticals. These gelatin derivatives and neutraceuticals have been developed by Sterling for its existing customers in western world, which are large pharmaceutical and neutraceuticals companies including Fortune 500 companies. Glenmark acquires an Argentine firm Glenmark Pharmaceuticals SA (GPSA), a wholly owned Swiss subsidiary of Glenmark Pharmaceuticals Ltd, acquired an Argentine marketing company Servycal SA for an undisclosed consideration. This 100 percent all-cash acquisition, funded through internal accruals of GPSA, marks the direct entry of an Indian pharmaceutical company for the first time ever in Argentina. Servycal, with a focused oncology portfolio, will enable Glenmark to expand its geographical scope and breadth of product offerings in the fast growing South American pharmaceutical markets. The company owns a basket of 17 approved product registrations with an additional three products pending registration. Apart from Argentina, Servycal's products are registered in 12 other South American country markets. Biocon's H1 net profit drops 22% Despite performing well in research services, insulin and other pharmaceutical products Biocon Ltd's net profit dropped by 22 percent at Rs 82 crore for the half year ended September 30, 2005 as against Rs 105 crore during the corresponding period last year. However it has registered a consolidated sales growth of 4 percent at Rs 375 crore during H1 FY 2006 as against Rs 360 crore in the corresponding period last year. The Q2 performance was significantly stronger than Q1 and revenues were up 15 percent and PAT increased by 13 percent. Kiran Mazumdar-Shaw, chairman & managing director, Biocon Ltd, said, "Given the challenges in the European Statins market, I am satisfied with our results. We are seeing strong growth in important parts of our business. We have many excellent growth drivers that are beginning to bear fruit. Our discovery-led research programs in diabetes and oncology are making good progress. We are on track to complete Phase IIB clinical trials for our EGFR antibody, Biomab-EGF by the year-end. We also expect to submit an IND for our oral Insulin molecule, IN105 by the end of this fiscal. I would like to reaffirm our belief in our innovation pathway that will deliver long term, sustainable value." Wockhardt's net profit up 17% Wockhardt Ltd reported a 17 percent rise in net profit for the third quarter ended September 30, 2005. Sales at Rs 359 crore showed a 12 percent increase over the corresponding quarter of 2004. Operating profit increased by 9 percent to Rs 88 crore during the quarter and operating margins stood at 24.3 percent for the period. Its newly created Biotech Strategic Business Unit bagged a tender for supply of insulin to Chile. Wockhardt has received company registration for its biopharmaceuticals in the Gulf Cooperation Council (GCC) countries. The total approvals so far are 25. Sterling Biotech's net profit up 57.5% Sterling Biotech has continued to report a robust growth during the third quarter ended September 2005 on back of higher capacity from Ooty unit. Its net sales rose by 17.7 percent to Rs 122.47 crore as against Rs 104.03 crore for the third quarter of the previous year. Net profit has risen much faster by 57.5 percent at Rs 28.64 crore as against Rs 18.19 crore during the same period. The margin at net level has risen due to operational efficiencies, expanded capacity, value added products and lower interest charges. ]]> <![CDATA[Indo-German Symbiosis]]> https://biospectrumindia.com/news/95/4554/indo-german-symbiosis.html https://biospectrumindia.com/news/95/4554/indo-german-symbiosis.html Fri, 11 Nov 2005 13:53:00 +0530 Indo Indo-German Symbiosis The collaborative route will allow the small and medium enterprises in both countries to reach out to enhance research and business opportunities. Utkarsh Palnitkar Director, Life Sciences, Ernst & Young India. Germany is one of India's oldest collaborators in Science & Technology (S&T), the collaboration dating back to the 1970s. S&T cooperation is reckoned as one of the main pillars of Indo-German bilateral relations. Trade ties between India and Germany have been improving by the year as is evident by the record levels of Indo-German trade in the year 2004. For the first time in history, Indo-German trade crossed the $7.21 billion (6 billion Euros) mark. Indian imports from Germany grew by almost 35 percent, while exports to the country grew by 11 percent. The Indian imports from Germany in the pharmaceutical sector amounted to $99.4 million in 2004 and have shown a 31 percent growth in 2003-2004. The Indian pharmaceuticals exports to Germany on the other hand have grown by 4.09 percent (Source: Indo-German Chamber of Commerce) Pharma Sector a Catalyst While Germany is the largest pharmaceutical industry in Europe and its healthcare expenditure is the 3rd highest in the world after the US and Japan at $219.6 billion, India is one of the fastest growing pharmaceutical industries in the world. The size of the German pharmaceutical industry is sizably larger at $43.5 billion as compared to the Indian industry at $8.7 billion. However, it is the Indian pharmaceutical industry which is growing at a faster pace of 7.2 percent as compared to the 3.5 percent growth rate of the German industry. (Source: Epsicom Pharmaceuticals Market Fact Book 2005). The pharmaceutical industries in both countries have already witnessed high levels of cross border activity, with the Indian firms expanding operations to Europe via Germany and the German firms either setting up subsidiaries in India or outsourcing a part of their activities. Torrent Pharmaceuticals of India acquiring Heumann Pharma GmbH & Co in 2004, through their German subsidiary, exemplifies this trend. On the other hand major players such as Boehringer Ingelheim, have setup shop in India and have scaled up operations through joint ventures and alliances. For instance, Boehringer Ingelheim had entered into a tie-up with Zydus Cadilla to manufacture and market its drugs (cardio-vascular) in India. A Biotechnology Perspective Biotechnology in India has evolved as a high growth industry owing to a strong science base, a booming Indian economy, increasing globalization and a proactive developmental effort by the government. Consequently there exists a distinct possibility of innovative product launches, collaborations and partnerships to take India's biotechnology sector to the next level. One of the core strengths of the Indian biotechnology industry is the availability of trained manpower. This has been possible because of the extensive network of research laboratories and institutions. In addition around 200 companies currently employ around 25,000 scientists for R&D. Further, the industry has clinical trials and research access to the vast and diverse disease population. Considering Genomics is an integral part of the biotech sector, the biodiversity in terms of the human gene pool offers an exciting opportunity for research in the area. Another factor which has influenced increased MNC investment in India in the industry has been the demonstrated success of biotechnology through companies such as Biocon. Biocon, India's leading biotechnology company, recently went for an Initial Public offering, raised $71 million and was oversubscribed 32 times. Gaining confidence in the market potential, a few global biotechnology companies have either planned or have made direct investments in the biotechnology industry. For instance, the Moscow-based Shreya Life Sciences is investing $22.7 million in India. Continuing on the trend of MNCs investing in India and the domestic firms seeking markets to export/out-license their products, the focus has turned on the European market where Germany is a prominent destination. The German biotech industry is estimated to have 340 companies (Source: Beyond Borders) and employs as many as 10,700 people (Source: Deccan Herald, April 2005). Further, Germany is well known for its strengths in basic research and for its excellent universities and research centers including the Institute for Biotechnological Research (GBF) in Braunschweig, the Max-Planck-Institutes, the Fraunhofer Institutes, and the European Molecular Biology Laboratory (EMBL) in Heidelberg. The state of Hessen in Germany is one of the largest markets for biotechnology products and Frankfurt is an international center of finance in addition to being one of the leading production and distribution sites for biotech products worldwide. These locations are known for their internationally recognized research in academia and company related R&D. This offers a potential to collaborate between interrelated sectors in the health sciences industry. Opportunities Germany can invest in R&D activities in India for enabling growth and at the same time share established processes/technologies with the Indian firms. Likewise, Indian firms require a catalyst to reduce the time to market and establish market tie-ups in Europe either by setting up representative offices or R&D subsidiaries. For domestic firms dealing in areas such as oncology, inflammatory diseases, auto-immune deficiencies, cognitive dysfunctions and proteomics, Germany can serve as a suitable partner to collaborate owing to its existing R&D competencies and technologies in these areas. Currently, the German Biotech industry is in search for partners in the areas of bio-informatics, agri-biotechnology, drug discovery, cheminformatics, pre-clinical and clinical development, genomics products and in-vitro diagnostics. The high burn-out rate and high cost of commercialization are driving R&D companies in Europe to look for solutions in countries like India. For instance, three German companies are looking at outsourcing bioinformatics and formulations to India. While innovation is important in the knowledge based industry today, the basic requirements such as access to innovative research and technology is a must, but which still eludes the small and medium enterprises in both countries. This gap displays a potential for mutual cooperation between India and Germany where India can provide the world class R&D facilities and manufacturing expertise, to produce innovative yet cost effective drugs. The potential becomes even more important in the context that the German landscape is still littered with large number of small cash starved companies which have small pipelines. In this situation, good science can be bought for an attractive price. The collaborative route will allow the small and medium enterprises in both countries to reach out to enhance research and business opportunities. Lucrative initiative Recognizing the existing potential for harnessing mutual capabilities, the Indo-German Biotechnology Cooperation has been conceptualized. This is a partnership between the Karnataka Biotechnology Development Council (KDBC), the international technology network (INTEC) and the Frankfurt Biotechnology Innovation center (FIZ). This initiative aims at creating a platform for supporting Indo-German collaboration in R&D, technology, marketing and manufacturing. As part of this initiative, a German biotechnology delegation participated in the Bangalore BIO 2005. Further, the KBDC plans to conduct road shows and seminars across Germany every year. In addition, some firms have gone in for joint ventures such as Sartorius India Pvt. Ltd which is a biotechnology engineering major that provides total solutions from designing to commissioning of bio-reactors. Three biotech companies - two from Bangalore and one from Pune are planning to set up research centers at the Frankfurt Innovation Center for Biotechnology. Companies such as Rhein Biotech and Bayer AG from Germany started with engagements in drug discovery, technology licensing and outsourced production. Rhein Biotech later was bought over by Wockhardt. This gives a glimpse into the inorganic growth which Indian firms are planning to leverage the technological capabilities of the German firms. Another significant example is Ocimum Biosolutions which recently acquired the genomic diagnostic division (micro array facility) of the German major MWG Biotech AG. The Way Ahead Whilst the Indian market is attractive for German investments, the Indian companies are also integrating with the world-markets. Germany has always occupied a priority position for Indian business being a leading global power in Science & Technology. For Indian companies, business with Germany means, being able to integrate with the largest pharmaceutical industry in the European Union, to access cutting edge technologies, to innovate products, to absorb best practices and to expand businesses in more regulated markets. Although India has many of the core strengths required for a successful biotechnology sector, there exists a scope of improvement in terms of establishing diverse and collaborative relationships. This co-development will facilitate production and distribution of innovative biotechnological solutions. ]]> <![CDATA[Catalysts for Success]]> https://biospectrumindia.com/news/95/1015/catalysts-for-success.html https://biospectrumindia.com/news/95/1015/catalysts-for-success.html Fri, 11 Nov 2005 13:50:00 +0530 Catalysts for Success Catalysts for Success There is a lot of potential to develop bioactive compounds and related functional foods and nutraceutical products from cereal, oilseed, legume, and other crops. Digvir S Jayas Distinguished Professor Interim Director of the Richardson Centre for Functional Foods and Nutraceuticals Canada Research Chair in Stored-Grain Ecosystems and Associate Vice-President (Research) University of Manitoba Winnipeg, MB, Canada. T he approach to utilization of crops has traditionally been from a food perspective, but changes which are occurring in legislation and regulations in Canada and around the world are leading to a more holistic, health promotion perspective regarding the value of these crops. It is recognized that many of the secondary metabolites of these plants have therapeutic and health-promoting properties. Under US legislation, many of these plants or their derivatives can be marketed in foods and as supplements, with relevant claims for health-promoting properties. Recently, Canadian regulations have permitted disease risk-reduction claims on five food extracts with proven physiological value. Consumers and regulatory agencies are demanding scientific evidence for claims made by distributors of functional foods and nutraceuticals. Currently, there are products that are being marketed based on anecdotal information or on very limited research. Such products have the potential to create serious danger to consumers through interactions with prescription or non-prescription medications or through over-consumption. Other products have significant potential for health benefit and also must be shown to be safe, efficacious and of high quality. Development of these functional foods and nutraceuticals will require interdisciplinary research involving experts from: (i) food sciences and nutrition to identify and isolate novel bioactives and to develop food and health products that incorporate these ingredients; (ii) food chemistry to determine the structural/molecular basis for physiological activity and to evaluate potency and functionality in food formulations; (iii) engineering to develop innovative processes for extracting bioactives; (iv) plant science to enhance the bioactives using plant breeding and genetic engineering; (v) medicine, animal, and human nutritional sciences to conduct basic research in defining the pathways of utilization of bioactives by the cell, animal, and human systems, and assessment of health benefits; (vi) pharmacy to conduct research on the development and evaluation of new products for promoting the health of consumers and on possible reactions with pharmaceutical agents; and (vii) human nutritional and food sciences to conduct consumer sensory testing and education. Such integrated research is needed both for the growth of the functional foods and nutraceuticals industry and to provide efficacious and safe products to consumers in Canada and throughout the world. Identification of Bioactives Most crops as excellent candidates for value-added processing as functional foods and nutraceuticals. Some example crops are: oats, wheat, and buckwheat, for their non-starch polysaccharide components; and canola, flax, borage, and hemp seed, for their fatty acid components. Complementary expertise in carbohydrate, protein, lipid and analytical chemistry are needed to identify components of interest in plants. It is necessary to identify which molecular features (e.g., composition, substitution groups, polarity and weight) of these biomolecules are responsible for specific bioactive properties, and how functionality is influenced by interactions with other polymers, solvents or solutes present in plant material or in food systems. Enhancement of Bioactives Enhancement of bioactives in plants can be done using plant breeding and genetic engineering techniques thus requiring expertise of plant scientists, breeders, and biotechnologists. The research is needed to decide which crop, which variety and which tissue is the best source for recovery of a bioactive. Enhancement could also involve introduction of genes responsible for the bioactive at sites in the plant other than those which occur naturally, without affecting agronomic characteristics, to facilitate higher levels of production, ease of extraction or ease of consumption. Knowledge of the chemical nature of the bioactive will, in many cases, allow the identification of the pathway involved in the synthesis of that constituent. Plant physiologists, with an understanding of the role played by that constituent in the plant, will determine if the pathway can be successfully "up-regulated" to allow greater production of the bioactive without negatively affecting plant productivity. This up-regulation can be achieved by evaluating the natural variation that exists within the population for selection within a conventional breeding program. Alternately, a genetic engineering approach could be used to modify the expression levels of critical steps in the pathway. Development of Functional Foods At the present time, food and bioprocessing are largely developed by empiricism and trial-and-error. There is an urgent research need to develop quantitative and systematic engineering approaches for scaling up processes and for efficient and cost-effective processing of biomaterials. This kind of research is being done on a very limited scale around the world because most research institutes do not have a well equipped pilot plant where such research can be done. Also, such a pilot plant must be supported by well equipped analytical labs. Research is needed on optimization of product formulations, optimization of process parameters, component stability, effective packaging techniques, delivery systems, and quality control methodologies. Assessment Establishing the safety and health-promoting value of these nutraceutical products will require studies on the metabolism, pharmacokinetics and pharmacodynamic nature of the active ingredients. Researchers from human and animal nutritional sciences, pharmacy, pharmacology, physiology and other health related expertise must conduct in vitro and in vivo studies to determine these properties for candidate nutraceutical products. Hepatology studies in animals and in ex vivo experiments will be required to obtain additional information on metabolism and kinetic properties. Also, of critical importance is the examination of ameliorative effects of nutraceuticals on known risk factors and markers for the development of chronic diseases such as cardiovascular disease, cancer, osteoporosis, Alzheimer's disease, and type-II diabetes. In vitro studies must be complemented by controlled metabolic studies that will be conducted to specifically measure the in vivo effects of test phytochemical consumption on biochemical markers/risk factors for several diseases. The research team must have access to numerous animal models of chronic diseases to evaluate the effectiveness of phytochemicals on slowing the progression of these diseases. The assessment of bioactivity in animal models is critical for the identification of candidate phytochemicals to be tested in human clinical trials. Consumer related research will also be required to ensure that functional food and nutraceutical products meet the requirements of taste and fit with lifestyle and culture. Research Coordination Research projects may begin at various points depending on what is currently known about specific bioactive phytochemicals. For example, if only the beneficial health properties of a food are recognized but the responsible bioactive is unknown, then work could begin at the analytical level to identify the responsible agent. This type of project would progress through analysis and characterization in the analytical labs but would also involve feeding or clinical tests at various stages to ensure the bioactive compound is being followed successfully. Once the bioactive constituent is identified, and a specific technique for quantifying the constituent is developed, the project material and information on bioactive characteristics must be passed to a team involving food scientists and food engineers to develop pilot scale procedures for enrichment and/or extraction of the bioactive from the source material. This stage might again involve feeding trials or clinical work to look at bioactive stability during processing. If a nutraceutical product were the goal and a pilot plant scale process can generate a pure or an enriched form of the bioactive, this product could be provided to other researchers with expertise in: (i) assessing safety through feeding studies and; (ii) pharmacokinetics/pharmacodynamics, to study the metabolism of the bioactive. Assuming a range of safe consumption can be identified, the material could then be tested for its health-promoting benefits as a nutraceutical in clinical trials. Once the health- promoting value of an identified bioactive, in either a functional food or nutraceutical is confirmed, and its potential value as a commercial product identified, plant scientists could use their expertise to assess alternative plant and cultivar sources of the bioactive. Depending on the limitations of bioactive yield provided by the available source, a decision would be made as to the feasibility and implications of enhancing the bioactive in the available or alternative plant source. In cases where a beneficial bioactive constituent is known, it could enter the development stream at various points and advance through it according to the information available. ]]> <![CDATA[Surveillance key to Bird Flu control]]> https://biospectrumindia.com/news/95/2054/surveillance-key-to-bird-flu-control.html https://biospectrumindia.com/news/95/2054/surveillance-key-to-bird-flu-control.html Fri, 11 Nov 2005 13:47:00 +0530 Surveillance key to Bird Flu control Surveillance key to Bird Flu control The H5N1 bird flu strain virus causes the disease and it has turned alarmingly contagious in Asia. Dr Mahesh Kumar Senior Director, Fort Dodge Animal Health Division at Wyeth MKUMAR@fdah.com A vian influenza or bird flu as its commonly called has taken on increas- ing significance in the past few years. The virus that is in the news lately is a high pathogenic avian influenza of the H5N1 subtype. This virus has caused severe mortalities in domestic poultry and several other bird species. It has taken on special significance, of course, because of its ability to infect humans and cause death. While there have been deaths associated with the H5N1 virus in Thailand, Vietnam, Cambodia and Indonesia, the infections are believed to be a result of exposure to infected bird rather than spread from human to human. This fact is significant. The moment the virus is able to spread readily from human to human, the human population will be facing an influenza virus that we have had no immunity against. The current vaccines do not contain the H5 strain and will be ineffective in preventing the disease. Flu pandemic Pandemics (world-wide epidemics) are common to influenza and appear on the planet every so many years. A pandemic occurs when a new subtype emerges that has not been previously circulating in the human population. The first known flu pandemic was in 1918 commonly called the Spanish flu was caused by an H1N1 strain of avian influenza. It was considered the most severe influenza outbreak causing an estimated mortality of over 50 million worldwide. The mortality rate was very high in India with approx 50 deaths/1000 people. Other pandemics were milder, the Asian Flu of 1957 was caused by an H2N2 virus causing 2 million deaths worldwide followed by the Hong Kong Flu pandemic (H3N2) of 1968 causing 1 million deaths. Influenza viruses are commonly described on the basis of the 2 proteins, the Haemagglutinin (H) and the Neuraminidase (N). There are 16 haemagluttinins and 9 neuraminidases for a possible 144 potential subtypes. While the viruses keep to their host species, occasionally, they can jump to another host species. This is usually because of the mixing of genes that occur during concomitant infections of strains from 2 species. While this was the case in the 1957 and 1968 pandemics, it has now been reported that the 1918 virus jumped directly from bird to human. The 1918 virus has now been completely studied and genetic changes that may have allowed the adaptation of this virus from bird to human have been identified. More importantly, the current bird flu strain (H5N1) shares some of these same mutations, which may be the reason why the current virus is able to infect humans. Current influenza vaccines for humans are comprised of the H1, H2 and H3 subtypes and do not offer protection against the H5N1 strain currently circulating in Asia. Avian influenza Avian influenza refers to a large group of different influenza viruses that primarily affect birds. It has traditionally been controlled by eradication or stamping out policies. If an outbreak were to occur, that area is quarantined and the birds are de-populated. Recently, some countries have used vaccines to aid in the control of avian influenza, namely Mexico, and Italy. Other countries have used vaccines sporadically and in well-defined situations in the control of the disease. While eradication makes sense in certain situations, it may not be possible in the case of avian influenza as the true reservoir for the virus are wild birds like ducks and geese that are not symptomatic (don't exhibit overt signs of disease or die). Complicating this is the migratory bird population that can transmit the virus over "national" and "international" boundaries. While vaccines are available to control the disease in birds, they can be applied effectively only to captive species not wild birds. Herein lies the problem. Current Situation Birds: The H5N1 strain is clearly spreading west in the bird populations. There are reports daily of new deaths in birds in European countries like Greece and very recently in a parrot in Great Britain (the bird was in quarantine). As the migratory seasons begin, there is likely to be many more cases of infected birds in Asia and in other Western countries. India is no exception and will likely find the bird flu virus in migratory birds and perhaps in domestic poultry in the near future. Control of the problem should be a combination of eradication, and vaccination. Vaccinating in a ring around the affected areas and containing the problem. Vaccines are currently available that are effective against the H5N1 bird flu. An effective vaccine should contain the relevant antigen that is properly standardized and of high quality. Fort Dodge Animal Health has several vaccines for avian influenza (for birds) that have demonstrated efficacy against the highly pathogenic H5N1 virus. The vaccines should allow differentiation of vaccinated from infected animals; this is usually accomplished by using a vaccine containing the same H5 antigen but different N type than the circulating virus. For example, an H5N9 or H5N3 vaccine will be effective against the H5N1 circulating virus but the N9 or N3 will allow the vaccinated bird to be distinguished from a naturally infected bird. This is because the H protein/antigen is mainly responsible for protection. Proper bio-security, cleaning and disinfection are also extremely important in the control of the disease and cannot be overlooked. Humans: The virus as yet is unable to move from human to human, but if science and history hold true, it is just a matter of time. The virus is clearly very pathogenic in the few who have been infected. Mortality is greater than 50 percent in infected individuals, with over 70 known deaths to date. More tragic is the mortality rates in children. In Thailand, the fatality rate was greater than 89 percent in children younger than 15 years of age. Many scenarios have been presented in the last few months on potential spread of the virus. Some estimate the pandemic can circle the globe within 15 months and cause over 150 million deaths. However, due to mitigating factors such as medicines and perhaps vaccines along with properly executed emergency plans, the number of fatalities will be far less. One thing is certain, if the virus behaves as the Spanish flu virus did it will cause many deaths and clearly travel today is different from the last century and will speed the spread of the virus. There are effective anti-viral medications that one can take to contain the virus, however not all are effective against this virus. Amantadine is totally ineffective; all virus isolates of H5N1 from the recent epidemic contain the mutation, which makes them resistant to this drug. However oseltamivir (trade name, Tamiflu) and zanamivir (trade name Relenza) are still effective against the virus. While antiviral medications are effective, one must recognize the symptoms and start the treatment quickly for it to be effective. Concerns exist over the supply of the drug and whether the drugs would be made available to all in need. While medicines can be used after an infection, the better option is of course vaccination. Effective vaccination will prevent many deaths in what is clearly to become a pandemic. However, there are no vaccines for people that are available today. Many companies are in the process of developing the vaccine with several government agencies helping to fund the progress. Hopefully, by mid 2006 vaccines will become available. In the meantime, proper surveillance and control will buy us much needed time until vaccines and anti-viral medications become readily available. ]]> <![CDATA["My vision is to bring Asian countries together"]]> https://biospectrumindia.com/news/95/4251/my-vision-is-to-bring-asian-countries-together.html https://biospectrumindia.com/news/95/4251/my-vision-is-to-bring-asian-countries-together.html Fri, 11 Nov 2005 13:45:00 +0530 New Page 1 "My vision is to bring Asian countries together" â€“Dr Anwar Nasim, founding President, Federation of Asian Biotech Associations (FABA) What progress has the Federation of Asian Biotech Associations (FABA) made to meet its objective of promoting biotechnology in Asia in over a year's time? Personally I feel that the creation of FABA provides an opportunity for biotechnologists from India and Pakistan to meet and develop strategies for future collaboration. As a matter of fact, during the launch of FABA, a colleague called this vaccine diplomacy similar to cricket diplomacy. A number of activities have followed after the launch of FABA in February 2005. During the last less than two years, I have been to India four times - twice to Hyderabad, once to Ahmedabad to attend the Science Congress and recently to Mumbai. I emphasize this because as far as my knowledge goes, this is the first formal effort to bring scientists from the two countries closer with efforts to promote business opportunities in biotechnology. I personally feel this is an achievement. We still find many obstacles/restrictions on number of visas granted to scientists by both governments. That often requires researchers to wait for a long time before they can confirm their journey to their hosts in the neighboring country. Although there is good news on increasing relations between the two countries, travel between the countries still remains somewhat difficult. What model has FABA adopted to reach out to all the corners of Asia? FABA has registered its own constitution, which permits the Federation to enroll any Asian country as its member and establish its chapter for carrying out local activities and also coordinate with the headquarters located at Hyderabad (India). FABA is making all-out efforts to enroll most of the countries in Asia as its members through personal contacts. The key approach for FABA is to strengthen the cooperation between India and Pakistan and then launch this on to other Asian countries. I have already contacted Bangladesh, China and Japan. The main objective is for Asian countries to join hands to benefit from the industrial potential of biotechnology. India and China have already made very impressive progress in biotechnology and hope other Asian nations can benefit from their experience. Which countries have joined FABA as members? How would they be benefit from membership? During the formation of FABA in February 2004, we had eight founding members - India, Israel, Malaysia, Pakistan, the Philippines, Singapore, Sri Lanka and Thailand. But when we formally launched in February 2005, two more countries, Iran and Saudi Arabia joined FABA totaling the strength to 10. FABA will start independent chapters in all the member countries. Countries like Yemen, China, Japan, Bangladesh and Turkey are negotiating for membership through their biotech organizations. Correspondence is in hand and hopefully some of these countries will become members shortly. FABA is designed as a platform that will help the member countries to tap each other's strengths for the development of biotechnology in the Asian region. FABA will also try to help the member organizations (biotech companies and academics) to become familiar with biotechnologies that are available in the region through hosting trade shows and fostering links among industry players and between industry and academia. FABA will also help the members to obtain royalties, perhaps with better terms than they might get if they were negotiating on their own with companies from developed countries. What are the initiatives/activities FABA has taken so far to act as bridge between various stakeholders of biotechnology industry among member countries? Keeping in mind the objectives of the FABA, we organized a two-day tripartite-planning meeting on agriculture biotechnology in Lahore in May 2005. Besides the local scientists, we invited leading scientists from the US and India such as Dr Roger Beachy, Dr Patricia Wrightson, Dr MS Swaminathan, Dr V L Chopra, Dr Manju Sharma, Dr C R Bhatia and Dr R K Singh to discuss and develop collaborative projects and to identify partners for joint ventures so as to overcome the overlapping issues pertaining to agriculture sector in India and Pakistan. A website of FABA has been finalized and it will be hosted shortly. What is your future plan of action? Considering the good response to our first initiative in Pakistan, we have planned many activities for the benefit of the member countries and also for mutual interaction between biotech industries located in different countries: The Pakistan chapter of FABA is organizing a workshop/conference on "Business Opportunities in Industrial Biotechnology: Destination Pakistan" to be held at Lahore, from December 6 to 8, 2005. Representatives from all member countries, particularly India and Pakistan are expected to participate in this conference. The accords already signed between Pakistan and India during BioAsia 2004 and 2005 will be reviewed, the progress made so far and further actions to implement these accords will be taken in those cases where not much progress has been made. During this conference, FABA proposes to cover topics like human and animal vaccines, emerging biotech products, human genetic disorder and diagnostics, herbal drugs, transgenic crops and animals in agri-biotech and novel drug delivery system. These topics are of great importance for both India and Pakistan for developing mutual business. FABA is actively involved in organizing BioAsia 2006 with AIBA-SC and AP government during February 2006 at Hyderabad. FABA is involved in organizing an international conference on "Biotechnology for Sustainable Agriculture and Agro-industry" along with Andhra Pradesh Industrial Development Corporation (APIDC), Andhra Pradesh government, AP Netherlands Biotechnology Programme and some others, from March 9-11, 2006 at Hyderabad. Topics such as biotechnology for improvement of seeds, food production, post harvest technology, gene technologies for stress tolerance, biotechnology for live-stock improvement, medicinal plants and energy plantations, non-chemical approaches in farming, biopharmaceuticals, and nutraceuticals, emerging trends in aquaculture and marine biotechnology and B2B meetings for establishing collaborations, joint venture, outsourcing and contract research are being included in this conference. FABA has taken steps to organize a two-week training program on "Basic Recombinant DNA Technologies" for about 10-15 participants (one each from its member country) during September 2006. The director, Centre for DNA Fingerprinting and Diagnostics (CDFD) has agreed to provide this training and required facilities at his institute. Details are being worked out. My vision of the future is to bring Asian countries together and see how best we can benefit by involving the industry to help benefit from biotechnology. Europe EU Court overturns Austrian law to ban GM crops The Court of First Instance has ruled on the case brought by Upper Austria and Austria against the Commission in regard to the former's Article 95 ban on planting GMOs. The court rejected all four of the applicant's legal pleas, having found them to be misplaced, unfounded, or irrelevant. The court dismissed all of the actions brought by the applicants. The court said the member state had failed to show that the measure was scientifically justified. The court said a deviation from EU law was not warranted in this case, and that the arguments used to invoke the precautionary principle lacked substance. The actions were dismissed in their entirety and the costs to be paid by the region "We are satisfied that EU law, which member states including Austria only recently put in place, has been upheld. The ruling confirms that member states may not abuse safeguard procedures to prohibit the use of safe, licensed GM products in their territory," said Simon Barber, director of the plant biotechnology unit at EuropaBio â€“ the EU Association for Bioindustries. The Republic of Austria, on March 13, 2003, notified the Commission of the OberÃ¶sterreichisches Gentechnik-Verbotsgesetz 2002, a draft law of the Land OberÃ¶sterreich (Province of Upper Austria) banning genetic engineering. The measure was intended to prohibit the cultivation of GM seed and planting material and secure a derogation from EU rules (Directive 2001/18). The notification relied on a repo rt entitled GMOfree areas of farming: conception and analysis of scenarios and steps for realisation. The Commission requested the European Food Safety Authority (EFSA) to issue an opinion on the scientific information relied on by the Republic of Austria. Source: www.europabio.org Council fails to vote on biotech maize The European Union (EU) Agriculture Council of Ministers was unable to reach agreement on the import and processing of 1507 maize (1) - genetically modified with a Bt gene, making it resistant to certain insect pests and was jointly developed by Pioneer Hi-Bred International and Dow AgroSciences - including animal feed use in the European Union. The product is already approved in 12 other countries around the world and meets all the EU's regulatory requirements, including three positive safety opinions from the European Food Safety Authority (EFSA) for all its intended uses in the EU. While again some member states have failed to vote according to the positive scientific opinion by EFSA, it is heartening to note that more member states voted positively for approving 1507 maize than when this dossier was reviewed by the Regulatory Committee in May this year. "We hope that more member states will recognize the benefits of genetically modified organisms for Europe's agriculture, for the environment and for the developing world and evaluate them scientifically on a case by case basis," said Simon Barber, director of the plant biotechnology unit at EuropaBio, the EU Association for Bioindustries. "Denmark was one of the member states responsible for the moratorium and by dropping its blanket opposition to GMOs, has demonstrated its support for EU regulations and of the benefits of GMOs," he added. Source: www.europabio.org ]]> <![CDATA[EECA suggests govt to look at bioethanol]]> https://biospectrumindia.com/news/95/5413/eeca-suggests-govt-to-look-at-bioethanol.html https://biospectrumindia.com/news/95/5413/eeca-suggests-govt-to-look-at-bioethanol.html Fri, 11 Nov 2005 13:43:00 +0530 New zealand New zealand EECA suggests govt to look at bioethanol Bioethanol produced from forestry waste, straw, and waste paper could meet at least three per cent of New Zealand's petrol needs, a report commissioned by the Energy Efficiency and Conservation Authority (EECA) suggests. Earlier this year the New Zealand government agreed in principle to set a sales target for biofuels in law, after several months of industry consultation. The government's focus is on two types of biofuel - bioethanol to be blended with petrol, and biodiesel to be blended with diesel. Enough biodiesel can reportedly be produced from tallow to provide around five per cent of New Zealand's diesel, while the dairy industry could produce enough bioethanol to meet 0.3 per cent of the country's petrol needs. "Biofuel has great potential in New Zealand," Labour Minister Pete Hodgson said. "It can help improve the security of transport fuel supplies and offer worthwhile health and emissions benefits." Hodgson added that he wanted the transport sector have the choice of biofuel by 2008 at the latest. As an example of the benefits of biofuel production, a bioethanol refinery proposed in Taupo could potentially use willow plants grown in the area. Growing willow would provide an alternative land use for dairy farmers, and reduce the amount of nitrogen leaching into Lake Taupo. Other companies are reported to be looking at building biorefinery operations in various New Zealand locations. Biofuels are also gaining popularity internationally and are used in several countries, including Australia, Canada, Europe and the United States. Source: www.nzbio.org.nz Australia Australians for use of stem cells in medical research Recent research has shown that the majority of the public in Australia continue to regard the use of embryonic stem cells in medical research as acceptable, however, the public does not generally understand 'nuclear transfer' or 'therapeutic cloning' enough to be able to judge their acceptance. While the Australian public have strong attitudes towards stem cell research and human cloning, it is difficult to gauge public attitudes towards more complex issues, such as somatic cell nuclear transfer (also called therapeutic cloning) because the terms and the technology are poorly understood. Speaking at a forum on stem cells in Canberra, the manager of Public Awareness for Biotechnology Australia, Craig Cormick, said that the most recent research undertaken for the agency showed that when people do not have a high level of knowledge about a technology, they are likely to make emotive-based judgements. "Over 93 percent of respondents were aware of scientists using stem cells to conduct medical research, although less (78.4 percent), were aware that scientists used embryonic stem cells for research. 63.5 percent of respondents regarded the use of embryonic stem cells in medical research as acceptable. Looking at the risks and benefits of stem cell research, 75.9 percent saw the use of embryonic stem cells as beneficial while 43.1 percent of respondents saw their use as risky," Cormick said. The research study, undertaken by Eureka Strategic Research, involved a phone poll of 1067 people on broad biotechnology issues, and was supported with 13 focus groups. The research found that people do recognize a worthy objective, and are generally supportive of pursuing it, despite concerns. Source: www.biotechnology.gov.au Biotech crops reduce pesticide use by 6 percent After just nine years of commercialization, biotech crops have made a significant, positive impact on the global economy and environment, decreasing pesticide spraying and reducing the environmental footprint associated with pesticide use by 14 percent, according to a study. "Since 1996, adoption of biotech crops has contributed to reducing greenhouse gas emissions from agriculture and decreased pesticide spraying," said Graham Brookes, director of PG Economics, and one of the authors who conducted the study. "While greatly enhancing the way farmers in 18 countries produce food, feed and fiber, biotech crops have reduced the environmental footprint associated with agricultural practices. This study offers the first quantifiable global look at the impact of biotech crop production." The study, "GM crops: the global socio-economic and environmental impact - the first nine years 1996â€“2004," reported that biotech crops contributed to significantly reduced greenhouse gas emissions from agricultural practices. This reduction results from decreased fuel use, about 1.8 billion liters in the past nine years, and additional soil carbon sequestration because of reduced ploughing or improved conservation tillage associated with biotech crops. In 2004, this reduction was equivalent to eliminating more than 10 billion kg of carbon dioxide from the atmosphere, or removing 5 million cars - one-fifth of the cars registered in the UK - from the road for one year. Biotech crops have reduced the volume of pesticide spraying globally by 6 percent since 1996, equivalent to a decrease of 172.5 million kg, according to the study. That's equivalent to eliminating 1,514 rail cars of pesticide's active ingredient. The largest environmental gains from changes in pesticide spraying have been from biotech soybeans and cotton, which have reduced the associated environmental footprint by 19 percent and 17 percent, respectively. Source: www.pgeconomics.co.uk canada Canadians are firm believers in biotechnology BIOTECanada, a national association representing the broad spectrum of biotech constituents, released intriguing results from a national poll conducted by Pollara research during the first week of September. According to the study, an overwhelming majority of Canadians (81 percent) expect to see the benefits of biotechnology positively impact the environment, their health in general, and the Canadian economy. While Canadians generally feel good about biotechnology, almost one-third of them do not regard Canada as a biotechnology leader, or able to keep pace with the rest of the world. The results of the poll indicate Canadians want to see the biotechnology industry grow and produce results. "It's exciting to see that Canadians have a positive view of biotechnology and are looking forward to the benefits these innovative technologies will bring to society", said Peter Brenders, president and CEO of BIOTECanada. "However, for our country to meet the expectations of Canadians, our biotechnology companies need government action in two key areas: supporting capital formation, and creating a modern regulatory environment." Poll results clearly indicate Canadians remain concerned with the nation's ability to compete globally. Michael Denny, chair of BIOTECanada noted that, "We need to create an attractive investment environment to better leverage our world class science into well-financed companies. Simple changes can be made to encourage more investment in our companies." Source: www.biotech.ca China China soon to approve GM rice China could be the first country in the world to approve genetically modified (GM) rice. The State Agricultural GM Crop Biosafety Committee, the technical body that evaluates GM rice for research and marketing, is likely to meet in November, reported China Daily. On the agenda will be four varieties of GM rice developed by Chinese scientists - three insect-resistant varieties and a fourth that can withstand bacterial blight. The four breeds have been undergoing pre-production safety evaluation since last December. Quoting Zhen Zhu, a leading rice scientist, the China Daily reported that "China's GM rice technologies lead the world and they are very mature for commercialization." Source: www.chinadaily.com.cn   ]]> <![CDATA[Drugs Going Off Patent]]> https://biospectrumindia.com/news/95/1631/drugs-going-off-patent.html https://biospectrumindia.com/news/95/1631/drugs-going-off-patent.html Fri, 11 Nov 2005 12:32:00 +0530 Biogenerics market gaining momentum Drugs Going Off Patent  S.No Brand Generic Name Company US Patent   Name      Expiry 1 Claritin Loratadine Antihistamine Schering-Plough 2002 2 Augmentin Amoxicillin/clavulanate         potassium GlaxoSmithKline 2002 3 Intron A Interferon alpha-2b Schering-Plough 2002 4 Axid   Eli Lilly 2002 5 Relafen Nabumetone GlaxoSmithKline 2002 6 Avonex Interferon beta-1a Biogen 2003 7 Humatrope Somatropin Eli Lilly 2003 8 Singulair Montelukast sodium Merck & Co. 2003 9 Flovent Fluticasone propionate GlaxoSmithKline 2003 10 Flonase Fluticasone propionate GlaxoSmithKline 2003 11 Engerix-B   GlaxoSmithKline 2003 12 Nutropin Somatropin Genentech 2003 13 Lovenox Enoxaparin sodium Aventis Pharmaceuticals    2004 14 Diflucan   Pfizer 2004 15 Cipro   Bayer 2004 16 Lupron Leuprolide acetate Tap Pharmaceutical 2004 17 Lamisil Terbinafine hydrochloride Novartis Pharmaceuticals  2004 18 Paraplatin Carboplatin Bristol-Myers Squibb 2004 19 Xenical Orlistat Roche Laboratories 2004 20 Epogen Epoetin alfa Amgen, Johnson     or Procrit   & Johnson, and Sankyo 2004 21 Zocor Simvastatin Merck & Co. 2005 22 Prevacid Lansoprazole Tap Pharmaceutical 2005 23 Zoloft Sertraline hydrochloride Pfizer 2005 24 Pravachol Pravastatin Bristol-Myers Squibb 2005 25 Zithromax Azithromycin Pfizer 2005 26 Biaxin Clarithromycin Abbott Laboratories 2005 27 Zofran Ondansetron hydrochloride GlaxoSmithKline 2005 ]]> <![CDATA[Biogenerics market gaining momentum]]> https://biospectrumindia.com/news/95/2819/biogenerics-market-gaining-momentum.html https://biospectrumindia.com/news/95/2819/biogenerics-market-gaining-momentum.html Fri, 11 Nov 2005 12:17:00 +0530 Biogenerics market gaining momentum Biogenerics market gaining momentum With India becoming TRIPS compliant, local companies are looking at drugs going off patent and also the biogenerics market so that they can produce and market the products at an affordable price. During 2002-04, as many as 20 biotech drugs have lost their patents in the US. Of the many drugs, the US patents for 13 biotech products will expire during 2005. Similarly many other blockbuster drugs are expected to lose patent protection over the next few years, paving the way for competitors to legally manufacture biogeneric versions of the biotech products and market them. This represents tremendous potential for biogeneric manufacturers. Since there is no real need to invest in drug discovery and clinical development, biogeneric manufacturers can sell these products at lower prices than the patented original drugs. This is expected to not only encourage consumers to purchase generic alternatives but also receive support from governments and healthcare providers seeking to reduce expenditure on therapeutics. This is why the Indian government faced resistance from non-government organizations, both local and international organizations, when it passed an ordinance for the product patent in December last year. However, the high manufacturing costs for biologics compared to conventional small molecule pharmaceuticals present a challenge to biogenerics manufacturers. Companies in developing countries like India are looking at biogenerics as a large number of biologicals are slated to go off patent and the pipeline for potential generic launches is dwindling. Considering this, the market potential for biogenerics will grow significantly in the coming years. According to Frost & Sullivan estimates, the biogenerics markets in Europe and the US alone has the potential to generate sales of $16.4 billion by 2011 at an average annual growth rate of 69.8 percent. The branded biologic products generated an estimated $32 billion of sales for the biotechnology and pharmaceutical industries and represented the fastest growing group of drugs. While continued high demand, high prices, and applicability in previously untreatable conditions are behind the success of branded biologics, the absence of generic competition has meant that growth has gone unchallenged. By 2010, biologic products that accrue an estimated $11.2 billion worth of sales annually are expected to lose patent protection in developed pharmaceutical markets. Rajesh Jain, joint managing director, Panacea Biotec said, "It is estimated that drugs worth $60 billion will go off patent by the year 2010. This does suggest a great opportunity for Indian pharmaceutical industry that can leverage the expertise and capabilities developed in the field of process chemistry. Many Indian pharmaceutical companies have already made serious efforts to bring out and market cheaper generic version of these drugs." According to Beyond Borders 2005 - a global biotech report of Ernst& Young - Procrit (Recombinant erythropoietin) had recorded sales of $3,589 million in 2004. Similarly other leading biotech drugs like Rituxan (Chimeric monoclonal antibody; anti-CD20), Remicade (Chimeric monoclonal antibody; anti-TNF-alpha), Epogen (Recombinant erythropoietin), Enbrel (Recombinant fusion protein; soluble TNF receptor linked to IgG1), Aranesp (Novel erythropoiesis-stimulating protein (2nd generation EPO)), Epogin/NeoRecormon (Recombinant erythropoietin), Neulasta (PEGylated version of Neupogen) Avonex (Recombinant interferon beta-1a) and Pegasys/ Copegus (Recombinant interferon alfa-2a modified with PEG (monotherapy; also in combination with Copegus [ribavirin])) have recorded sales of $2,963 million, $2,891 million, $2,600 million, $2,580 million, $2,500 million, $1,826 million, $1,700 million, $1,417 million and $1,370 million respectively. This gives an idea about the market potential for these biotech products world over. Ernst & Young in its global biotech report also pointed out that Asia-Pacific nations such as India and China are emerging as major players in the development of a global market for biogenerics. Both countries are positioned to take advantage of moves by governments in the US and Europe to create a regulatory framework for approving generic versions of successful protein drugs. Opportunities Off the 50 odd biotech drugs 13 are available in India and seven biotech drugs are indigenously developed and produced by the Indian companies. "All the biotech products produced by Indian companies are generic in nature. India has a huge market potential for biogenerics. There are many products going off patent this year and in next couple of years. Insulin itself has a $5 billion global market annually. So the market potential for biotech drugs going off patent is huge. "Setting aside the present biogeneric market, I would say it would be in the range of Rs 500- 1000 crore by 2007-08 including the exports from India," said Dr Hemanth Nandigala, executive director, Virchow Biotech Pvt Ltd. On the opportunity for biogenerics, Jayashri Kulkarni, director - Healthcare Practice, Frost & Sullivan, India said, "While the opportunity cannot be compared to that in the international markets since it is limited by pricing constraints in the Indian context, the very indication given by the number of applications for import/clinical evaluation/ manufacture and market applications in the sector are evidence enough of the opportunity in biogenerics in India." Utkarsh Palnitkar, industry leader - health sciences too pointed out that the potential for biogenerics is definitely significant. However, the costs of conducting trials in the respective countries where these products are to be introduced should also be factored. Commenting on the market potential for these products, Jayashri Kulkarni said, "Typically the market potential in India for biogenerics has been in the range of 0.1 percent (EPO) to 0.2 percent of (Insulin) of the global market value based on the type and class of molecule. Pricing dynamics and the promotional message of make and market have played a crucial role in the market composition historically and will continue to dominate the market dynamics for the soon-to-expire molecules as well." " While the molecules currently marketed in India see majors like Wockhardt, Dr Reddy's and Shantha Biotechnics and now Biocon and Panacea Biotech which also have capabilities in developing the next group of products going off patent, quite a few companies are also preparing themselves to enter the market with the make and market strategy - these include Zenotech, Cadila, Ranbaxy, Intas and Serum Institute of India," she added. Alok Gupta, country head, life sciences and biotechnology, YES Bank Ltd said, "Some of the biotech products from Amgen, Serono, Johnson & Johnson, Genentech, Novo Nordisk, Eli Lilly, Pharmacia, Chiron, Biogen are in the list of patent expiry. Indian companies are working on these biotech products as they have a good market potential." "There have been various reports that one or the other company is working on somatropin (basically human growth hormone) but nothing confirmed yet. As such it is a bacterial derived product and not that difficult to make for any company already making similar products. Interferon beta has a large market internationally but its only approved indication is multiple sclerosis, and does not have a large market in India. Alteplase is tPA (tissue plasminohgen activator) and again, I have not heard of any companies in India pursuing this product. This is a mammalian cell culture derived product. Currently streptokinase seems to be the only Indian manufactured product in this category (same indication as tPA)," said Dhananjay Patankar, head biotechnology, Intas Pharmaceuticals. India is emerging as a key player as far as biogenerics are concerned. The domestic market sales from the biogenerics (only the recombinant biotech products) were estimated at about Rs 500 crore as many Indian companies are into both manufacturing and marketing of these products. Companies such as Bharat Biotech, Dr Reddy's Labs, Panacea Biotec, Shantha Biotechnics, Wockhardt, Biocon, Intas Pharmaceuticals, Shreya Life Sciences have showed that they are capable of producing biogenerics in India. These companies have already introduced as many as seven biotech drugs (Hepatitis B vaccine, Streptokinase, Insulin, G-CSF, Erythropoietin, Human Growth Hormone and Interferon alpha 2b) under many brands. With the introduction of these biogenerics, there is a drastic drop in the prices. Issues to look at Although there is a huge opportunity and market potential for the biotech drugs, there are some issues that might delay the companies to enter the biogeneric market. While the development of an abbreviated regulatory pathway is crucial to the approval of new biogenerics, growing concerns about the lack of a definition for bioequivalence and increasing pressure from major biotechnology companies anxious to defend their ailing blockbuster patents are preventing the growth of biogenerics market. This is currently the single largest hurdle facing the biogenerics market. And innovators are employing delaying tactics aimed at preventing the biogenerics players from taking shorter routes to approval. Development of second-generation products that are significantly better than the originals, meaning that original products are unlikely to take significant market share. Dr Hemanth Nandigala of Virchow Biotech said, "The only hurdle coming in the way of biogenerics is the regulatory system as there is no clear regulatory framework in USA, a huge market for biogeneric products. However, last year the FDA called for general opinion and feedback from the stakeholders to biogenerics. It is still compiling the same. On the other hand, Europe instituted a clear-cut pathway for the biogenerics products. Once the things are in place, then the opportunity for biogeneric manufacturers will be huge." Sharing similar views, Rajesh Jain of Panacea Biotec said, "The regulatory issues are not yet very clear especially for 'biogeneric drugs'. However, there are likely to be challenges in regulatory issues for biogeneric drugs." To overcome these hurdles, the biogenerics companies should look at strategies such as establishing strategic partnerships, expanding the operations through acquisitions, supplying into developing markets initially, followed by Europe and eventually the US and finally developing second-generation of products. Number of drugs with patents expiring in 2000-04 (Grouped by treatment category) Treatment category 2000 2001 2002 2003 1. Cancer and cancer related treatments 5 6 4 2 2. Anti-infective treatments 2 6 2 3 3. Central nervous system treatments 6 2 2 5 4. Cardiovascular/cerebro-vascular treatments 13 13 6 17 5. Respiratory treatments 5 3 4 5 6. Endocrine, nutritional, metabolic and immunity treatments 3 2 2 3 7. Topical treatments 5 1 3 7 8. Hormonal treatments 1 4 1 5 9. Musculo-skeletal and connective tissue treatments 1 0 1 0 10. AIDS and AIDS related treatments 2 2 0 1 11. Analgesic treatments 1 5 5 1 12. Digestive system treatments 5 1 5 0 13. Blood disorder treatments 0 0 0 0 In addition to adopting these strategies, the biogenerics companies need to be well financed, possess sufficient technical capability, and be operating to Western GMP standards, be sufficiently focused, usually on only one or two products, since they will need to understand the market segment they are entering and have sufficient finances to operate in the chosen market. These companies need to look at developing such products where they need to be certain that: there is no intellectual property barrier. Against all these odds there is some relief for the biogeneric companies as Europe has started accepting applications for abbreviated market approval of new biogenerics. Earlier, biogenerics companies were thriving in less regulated countries such as India, China and other developing countries like Africa. An European Medicines Evaluation Agency (EMEA) has recently issued guidelines for generic versions of some biopharmaceutical products. These guidelines will permit Indian companies to apply for approval to market generic versions of biotech products in Europe. But the US is yet to develop a shorter regulatory path to market biogenerics. Companies like Wockhardt, Dr Reddy's Labs and Biocon are looking at entering the regulated market in Europe, which has regulatory system in place for the biogenerics. Wockhardt has received 17 registrations for its biopharmaceuticals and 36 registrations are being pursued in various overseas markets such as Russia, South America, North Africa, Central Asia, South East Asia. It has also formed majority joint ventures in Mexico and South Africa and has set up a subsidiary in Brazil. Rajesh Jain said, "Panacea Biotec at the moment is working on several bio-pharmaceutical products and several new therapeutic molecules with its own IPR backing the development. One example is Hair Growth Utilizing Actin Binding Peptide." However, global biotechnology companies are likely to go to great lengths to reinforce their patents, reformulate existing products and improve delivery systems in an effort to maintain the customer base for their branded products. But once regulations are clearly established, one can see a flood of biogeneric alternatives to hit the market soon after the expiry of each blockbuster patent. Dr P K Ghosh said that in the infrastructure development, one strategic action the government could look at is to continuously publish the protection period of useful biotech products that are protected under IPR so as to draw the attention of entrepreneurs/researcher on a continuous basis. Dr KK Tripathi, advisor, Department of Biotechnology said, "Indian companies working on the products going off patent under the various provisions of the IPR, will enter the world market in a big way. They will be able to export the product if the FDA approves it. This will definitely open a big avenue for the Indian companies." Narayan Kulkarni with Rolly Dureha in New Delhi ]]> <![CDATA[Bio-Diesel From Field To Wheel]]> https://biospectrumindia.com/news/95/1996/bio-diesel-from-field-to-wheel.html https://biospectrumindia.com/news/95/1996/bio-diesel-from-field-to-wheel.html Fri, 11 Nov 2005 12:14:00 +0530 Bio Bio-Diesel From Field To Wheel India imports 70 percent of its oil requirement. In 2004 our crude oil import was in excess of Rs 1,20,000 crores. ($30 billion). About 70 percent of the total petroleum fuel consumed in India is diesel and 30 percent is petrol. Even if one-tenths of the import is substituted with bio-diesel, it is worth approximately Rs 12,000 crore ($3 billion) a year at 2004 oil prices. On October 9, the Ministry of Petroleum and Natural Gas notified a Bio-diesel Purchase Policy, which provides for purchase of bio-diesel by oil marketing companies at the rate of Rs 25 per litre (inclusive of taxes/duties/transportation cost) with effect from January 1, 2006, at about 20 purchase centers in 12 states. The suppliers should have the capacity to supply minimum 10KL per tanker of bio-diesel meeting prescribed BIS specifications and should be registered with the state level coordinator of oil companies. The blending of bio-diesel at a maximum of 5 percent will be undertaken initially at these 20 centers depending on its availability. Commenting on the purchase policy, Mani Shankar Aiyar, minister for petroleum and natural gas, said, "In view of the growing demand of energy to sustain economic development, the new policy aims at setting up public-private-panchayati raj partnership to encourage bio-diesel production by jatropha cultivation on the wastelands." Work Done in India on Bio-Diesel Development of high quality jatropha through tissue culture / nuclear route â€“ DBT, Aditya/Sheel Bio-tech, BARC (Trombay) Ongoing plantation by NOVOD, NAEB, NGOs and some private companies Bio-diesel pilot plants have been set up at IITs, IIP (Dehradun), IOC (Faridabad), PAU (Ludhiana), IISc (Bangalore), Railways, CSIR institutes (IICT, CSMCRI) Trans-esterification plant set up at Gurgaon (Capacity: 1 ton per day) Trans-esterification plants coming up: 300 ton/day and 30 ton per day in Andhra Pradesh, 5 ton per day in Sivakasi (Tamil Nadu) Trial runs on 5 percent bio-diesel blend with diesel being undertaken by: Rail ways, Mahindra & Mahindra (tractors), Haryana Roadways (IOCL), BEST Buses (HPCL), Daimler Chrysler (Mercedez cars) and Tata Motors. The BMTC and KSRTC in Bangalore run a few buses on diesel blended with 15 percent straight pongamia oil. Tamil Nadu forest department jeeps at Hosur being run on diesel blended with 15-20 percent Pongamia oil Tiruchi-Tiruchanapalli shuttle run daily on diesel blended with 5 percent bio-diesel He was speaking after inaugurating a conference on biofuels, "BioFuels 2012-Vision to Reality" organized by The Energy and Resource Institute (TERI) in New Delhi. He added that recently a MoU was signed among the 15 village panchayats of Faridabad and Mewat with a private company and the Indian Oil Corporation (IOC). Under the agreement, farmers will plant jatropha plants initially on 1,000 acres of land for the private company, which will later sell jatropha oil to the IOC at a minimum price of Rs 25 per litre. Thus, the policy will enable farmers and bio-diesel producers get support price of Rs 25 per liter for jatropha oil and targets to bring one million hectares of land under Jatropha cultivation to supply blended diesel within the next few years. Private industry initiatives The role of private sector in this area has been limited till now. Automobile companies like Daimler-Chrysler, Tata Motors Ltd. (TML) have been conducting trial runs with bio-diesel, in addition to doing R&D on process technology, etc. The specifications of bio-diesel are such that it can be mixed with any diesel fuel and can operate in any compression ignition engine, i.e. diesel engine. Biodiesel can be blended in any ratio with petroleum diesel fuel. The worldwide trend is to initiate the program with 2-5 percent blending and increase it to 20 percent and thereafter 100 percent in a phased manner. Dr Krishna Iyenger, manager, Engineering Research Centre, Tata Motors, said, "We are evaluating bio-diesel blend as a potential fuel and running trials on TML Staff-Bus fleet and on Indigo passenger car. In addition we are running joint trials with India Oil Corporation (R&D Centre) on car, LCV and engines. We are simultaneously studying the performance of the engine, emissions, specific fuel consumption, durability of fuel-system, engine, exhaust system, material compatibility and effects of fuel on vehicle operation. Our next step is the operation of TML Staff Buses on 20 percent bio-diesel blends and endurance trials on engines with 10 and 20 percent bio-diesel blends." Similarly, DaimlerChrysler has been testing the bio-diesel produced by the Central Salt and Marine Chemical Research Institute (CSMCRI) in Bhavnagar for about a year. CSMCRI has developed a process for refining oil from Jatropha seeds at a reasonable cost without intensive use of energy. DaimlerChrysler is now testing Jatropha biodiesel in two Mercedes-Benz cars and one Viano van in the Himalayan terrain to ensure the consistency in results and also test run the vehicles for more mileage. Some private companies have taken initiative in planting Jatropha and setting up bio-diesel production facilities. Southern Online BioTechnologies, a Hyderabad-based company is setting up 10,000 tons per year bio-diesel project in Chautupal, Nalgonda district, Andhra Pradesh. The foundation stone of the bio-diesel manufacturing facility was laid in early 2005 and the requisite technology support will be provided by Lurgi, Germany. The company is all set to conduct the trial runs in February 2006 and commercialize the biofuel by the first quarter of 2006. N Satish Kumar, managing director, Southern Online Biotechnologies said, "This is the first bio-diesel project to get a grant from GTZ, Federal Government of Germany because of the positive social, economic, and environmental benefits to local communities under bio-diesel segment. Also, the first bio-diesel project to get the host country approval from the Ministry of Environment, Government of India and the first bio-diesel project to go for validation/methodology approval under Gold Standard with the financial assistance from GTZ under terms of the Kyoto Protocol. We have obtained the letter of assurance for the sale of the bio-diesel from the Ministry of State for Rural Development, Government of India." On the recent bio-diesel purchase policy announced by the government, Kumar said, "The Government of India should reconsider the price of the biodiesel by evaluating the present price of the seeds/seed oil, processing expenses and other industry expenditure." A multinational company, which will soon set a base in India in the bio-diesel sector is the UK-based D1 Oils. This bio-diesel manufacturing company, will be setting up a 8,000 ton per annum capacity refinery in Chennai to produce bio-diesel in the country. The company is investing $2 million in India to set up the refinery, which is likely to be commissioned by 2007. D1 Oils, which has formed a joint venture with Mohan Breweries and distilleries, has begun large-scale jatropha cultivation in Tamil Nadu, Andhra Pradesh and Chattisgarh. The company plans to have five million hectares of land under jatropha cultivation and to produce 2.7 metric tons of oil per hectare within five years. Earlier this year, D1 announced a partnership with Labland Biotech, a Mysore-based plant biotech firm, to produce some 100 million tissue culture-derived Jatropha plants. On its part, Labland Biotech has tied up with the Biotechnology Park, Lucknow for providing good-quality Jatropha seedlings for large-scale plantation with an assured buy-back arrangement for seeds. The company plans to bring an estimated 1.25 lakh acres in Karnataka under Jatropha in the next five years. Besides, Ankleshwar-based Gujarat Oleo Chem has succeeded in commercializing the production of bio-diesel from vegetable based feedstock. The company has released the first commercial consignment of bio-diesel to IOC. Now IOC is conducting field trials with the Indian Railways and Haryana roadways. The Indian Railways had provided land in Surendranagar district of Gujarat for cultivation of jatropha seeds for this project. Gujarat Oleo Chem has drawn up an ambitious expansion plan to increase the production capacity of bio-diesel to 1 million tons per annum by 2007. The current level of production of bio-diesel is about 100 tons per day. The company is considering a joint venture for the proposed expansion for which it has received five to six proposals. The company has received encouraging response for bio-diesel both from within the country and outside, especially from Iran and the UK. Its product conforms to SPM specific D 6751, the international standard set by the US, and E DIN 51606, a European standard. National Mission The Government of India had set up a committee on development of bio-fuels in July 2002 under the chairmanship of Member, Planning Commission. The final report of the committee was presented to the Prime Minister's office in July 2003. The Ministry of Rural Development (MORD) was instituted as the nodal ministry for implementation of recommendations of the committee. The report recommended that the country must move progressively towards the use of bio-fuels, ethanol as substitute for petrol and bio-diesel as substitute for diesel. It has suggested launching a National Mission on bio-diesel based on Jatropha plantation. Present status As the Nodal ministry, the MORD decided to get a Detailed Project Report (DPR) prepared on National Mission on bio-diesel and the Letter of Interest was issued to The Energy and Resource Institute (TERI), New Delhi in May 2004 for preparation of DPR. Agencies in Bio-Diesel Program Planning Commission for over all coordination and monitoring. Ministry of Rural Development is the nodal ministry responsible for implementation of overall program. Ministry of Environment and Forests and NOVOD as coordinators of the plantation component. DBT for research related to plantation component. n Ministry of Petroleom & Natural Gas for facilitating buy back arrangements of bio-diesel. Ministry of Small Scale and Village Industries for supporting seed collection and oil extraction centres. Non conventional energy sources, IIP, IICT, IITs, CPCB etc. as R&D centers for studies to fill the relevant knowledge gaps. TERI submitted draft DPR to MORD in September 2004 and thereafter, with inputs from series of discussions and views taken from various stakeholders, ministries and final DPR was submitted to MORD in February 2005. In turn the MORD submitted DPR/proposal to Planning Commission for in-principle approval. At present the proposal is being examined and clarifications awaited from MORD. Later the EFC/CCEA approvals will follow. Bio-diesel program The National Mission bio-diesel program consists of two phases. The first phase consists of demonstration projects spread on about 4 lakh hectares covering both forest and non-forest lands in various states across the country. The phase II of the mission will focus on uncovered areas during the 11th plan with a target to achieve 20 percent blending of bio-diesel with diesel. The phase II of national mission is proposed to be people driven with the government playing the role of facilitator. It aims to expand the program to cover up to 11 million hectare in phase II during the 11th Plan. The implementation will be done in phased manner â€“ The first step is toachieve 5 percent bio-diesel blend in diesel in nine states; then aim at 5 percent bio-diesel blend in all over the country. Later the bio-diesel blend percentage will be increased to 10 percent across the country and lastly work towards more than 10 percent bio-diesel blend in the entire country. In order to achieve the set targets, the National Mission will look into nurseries development, plantation on forest and non-forest lands, seed collection and oil extraction centers, transesterification units, blending and marketing arrangements and research and development (R&D) studies to fill gaps in knowledge. In order to manage the entire program, there is a proposal to create a National Biodiesel Board. To provide impetus to this industry, Dr R Mandal, advisor, Planning commission, said, "Classification of bio-diesel industry should be as per central revenue act in the category of 'Renewable Energy', 'GHG reduction', 'Pollution substitution'refinery. This classification will help biodiesel industry in faster clearance of projects, priority sector funding at low cost from financial institutions and will also help avail subsidies /concessions from the concerned departments of the state. In addition, this will also help in deciding sales tax/excise duty/customs duty on bio-diesel." State government initiatives Many states have formed nodal agencies for bio-diesel development and announced draft bio-diesel policies, for example Chhattisgarh, Uttaranchal, Rajasthan, Andhra Pradesh and Tamil Nadu. These states have initiated plantation programs. For instance, the Uttaranchal Bio-fuel Board has planted Jatropha in 10,000 hectares in 2005; in Chhattisgarh 8 crore saplings of Jatropha have been planted; while Andhra Pradesh plans to plant Jatropha on 16,000 ha and 3.3 crore Pongamia saplings in the state and Karnataka has planted 2 crore Pongamia saplings. The states are also adopting different plant management approaches like Uttaranchal is using the joint forest management model on un-irrigated degraded forest lands; Chhattisgarh is using contract farming and joint forest management approach on waste fallow and agriculture land. Andhra Pradesh is planting Jatropha in agricultural land and Pongamia in the forests. Now the road ahead in the area of biodiesel is to hasten the implementation of the biodiesel program and the formation of National Biodiesel Board along with nurturing the private initiatives in this sector. Rolly Dureha ]]> <![CDATA[Glenmark Pharma files Phase I application in UK]]> https://biospectrumindia.com/news/95/7270/glenmark-pharma-files-phase-i-application-in-uk.html https://biospectrumindia.com/news/95/7270/glenmark-pharma-files-phase-i-application-in-uk.html Tue, 11 Oct 2005 15:32:00 +0530 Glenmark Pharma files Phase I application in UK Glenmark Pharma files Phase I application in UK Glenmark Pharmaceuticals SA (Switzerland), a wholly owned subsidiary of Glenmark Pharmaceuticals Ltd (Glenmark), has filed for Phase I clinical trials for GRC 8200, its leading DPP-IV inhibitor compound, with the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK. The Phase I study will be conducted by Parexel a UK-based CRO. And it would be completed in February 2006. Glenn Saldanha, managing director and CEO of Glenmark, said, "We have a very aggressive timeline and hope to be the fourth to market with GRC 8200 in the DPP-IV class. We expect GRC 8200 to be launched on the US market in 2010." Glenmark has an aggressive clinical development plan for GRC 8200 that will help reduce the gap with some of these competing molecules in early clinical trials. Along with Phase I trials, Glenmark plans to initiate a Proof Of Concept (Phase IIA) study in South Africa in January 2006 on diabetic patients. Further, it has already commenced various other non-clinical studies and expects to file an IND with the US FDA between April-June 2006 in order to commence Phase II. Glenmark has commenced early discussions with potential partners in the regulated markets to collaborate on the clinical development, filing and marketing of this product. This is in line with its policy of partnering its NCEs with strong development and marketing partners for North America, Europe and Japan. Zydus Cadila receives tentative US FDA approval Zydus Cadila has received tentative approval from the US FDA for its Abbreviated New Drug Application (ANDA) for Divalproex Sodium DR Tablets. The product, an anti-convulsant that falls in the CNS segment, will go off patent in January 2008. The annual sales of Divalproex Sodium DR Tablets as per IMS in 2004 in the US market were estimated at $680 million. The tentative approval for Divalproex Sodium DR Tablets is the latest in a series of developments that mark Zydus Cadila's foray in the US generic markets. So far the group has received 6 ANDA approvals. The group recently launched Atenolol in the US market through its US subsidiary Zydus Pharmaceuticals USA. The process of filing ANDAs began in 2003-04 with the group filing 12 ANDAs. Till date, the group has filed 27 ANDAs and 32 DMFs. CIMAP signs MoU with SRI on collaborative research The Central Institute of Medicinal and Aromatic Plants (CIMAP), Lucknow and Shriram Institute of Industrial research (SRI), Delhi have agreed to collaborate for joint projects in the area of product development based on medicinal and aromatic plants, towards developing international standards for herbals and R&D for plant molecular biology and biotechnology. A MoU was recently signed in this regard at CIMAP in Lucknow by Dr SPS Khanuja, director, CIMAP, Lucknow and Dr RK Khandal, director, Shriram Institute for Industrial Research (SRI), New Delhi. Under the agreement CIMAP shall extend need based technical guidance to SRI in a project mode in the area of medicinal and aromatic plants and their products and actively collaborate with SRI in the areas of mutual interest complementing the existing capabilities. BPO service for pharma and biotech industry Take Solutions, a technology enabled business solutions company, is all set to launch a new BPO for the pharmaceutical and biotech industry, by the end of December 2005, in Chennai. Take Solutions CEO, Ram Yeleswarapu said, "Pharmaceutical companies, from June 2005 are required to provide the United States' Food and Drug Administration (FDA) all products information in XML format in compliance with the structured product labeling (SPL) standard. This BPO division would help both pharma and biotech manufacturers satisfy the FDA norms. Besides, it will also benefit the Indian pharma and biotech exporters, to meet the FDA norms." Americos introduces trifunctional dyes Americos, an Ahmedabad-based firm mainly into production and marketing of enzymes, garment wash and textile specialty chemicals, auxiliaries, smart colorants, and dyestuffs has introduced trifunctional dyes, which are especially synthesized to produce cost effective cloudy effect on cotton garments. Speaking to BioSpectrum, Gaurav Khanna, director of sales, Americos Industries, said, "We have set up a state-of-the-art R&D center to remain abreast with the latest knowledge frontier and our focus has always been on producing Concept Driven Chemicals. The objective of this center is to achieve new developments in the garment and finishing industries." SPC Biotech to manufacture green plastic SPC Biotech, a Hyderabad-based company is working on to manufacture biodegradable plastics (green plastic) from agricultural feedstock like cornstarch using its own technology. SPC Biotech in association with Biopolymer Research Laboratory, Cuttack has done considerable research and developed the technology and will be commercializing an eco-friendly product. Speaking to BioSpectrum, MS Shankara Prasad, managing director, SPC Biotech said, "We have made an investment of about Rs 4 crore in the pilot project with an installed capacity of 300 Mt. The actual project will have an installed capacity of 10000 Mt with a project cost Rs 30 crore. And commercial production will start from August 2006." Sanofi Pasteur introduces Vaxigrip Sanofi Pasteur, a global vaccines player recently introduced Vaxigrip, its global preventive vaccine against influenza for the season 2005-2006 in India.Vaxigrip is a suspension for injection in prefilled syringe of 0.5m in a box of 1 or 20 or in an ampoule of 0.5ml.Vaxigrip is produced by Sanofi Pasteur in Lyon, France and is marketed in India by Sanofi Pasteur and Ranbaxy. In a press release, a Sanofi Pasteur spokesperson said, "Influenza is a more serious condition than a cold and can be life threatening for some people showing a high risk of associated complications. Vaxigrip can be administered to young children, working adults, pilgrims, elderly and patients suffering from diabetes, asthma, cardiac and pulmonary disorders." Strand's avadis achieves GeneChip-compatible status Strand Life Sciences announced that its avadis software application has achieved GeneChip-compatible status with the Affymetrix Inc. GeneChip microarray platform and that it has joined the Affymetrix GeneChip-compatible Applications Program, which provides customers with a broad spectrum of software solutions for biomedical research and development. As a GeneChip-compatible software provider, Strand Life Sciences is committed to seamlessly integrating its tool avadis with the Affymetrix GeneChip platform. avadis is Strand's flagship product and is a comprehensive tool for microarray data analysis. avadis brings in data mining techniques and software engineering to microarray gene expression data analysis. ]]> <![CDATA[Panel Discussion 4]]> https://biospectrumindia.com/news/95/2353/panel-discussion-4.html https://biospectrumindia.com/news/95/2353/panel-discussion-4.html Tue, 11 Oct 2005 15:19:00 +0530 Panel Discussion 4 Panel Discussion 4 Leveraging India's bioagri strengths Dr Sridhar Venkataraman, Dr P S Dravid, Dr KK Narayanan, Paresh Verma and V Ram Kaundinya. Should the government or industry take the lead to promote transgenic products? Should the groundwork be started for the introduction of GM foods in India? Dr KK Narayanan, managing director, Metahelix moderated this session to find out more that needs to be done for the agri sector. The panelists included Dr PS Dravid, president, JK Agrigenetics, Paresh Verma, head, BioSeed Research India, V Ram Kaundinya, managing director, Emergent Genetics, and Dr Sridhar Venkataraman, group leader, Avesthagen's "Seed for Food" division. "Both the private and public sector play a major role in their own way for the benefit of the common man. The government should play a key role where heavy investments are required. Besides it should also continue to focus on basic research by prioritizing the needs of the farmers. It should further take up the basic research to pilot scale and finally to farmers with end products. The government by putting a barrier on sale of Bt seeds is creating an artificial barrier to sell at higher cost. Since the companies are working on similar technology, the government should approve more seeds so that companies can sell their products at an affordable price. Overall the legal system should be reformed as many rules related to environment are violated." - Dr P S Dravid, president, JK Agrigenetics "There is need for a proper dialogue between farmers, research organizations, companies and others like NGOs and also educate the farmer on the use of biotechnology. They should be given information on the bio safety issues and on the latest technology coming up in the market. There should be appropriate IP protection for GM crops as still we don't have a strong implementation mechanism." - Dr KK Narayanan, managing director, Metahelix "About 65-70 percent of the total cotton cultivation comprises of spurious Bt seeds. Companies are selling illegal Bt cottonseeds in the open market. Enforcement is the biggest challenge. We have the rights of farmers to sell the seeds. Still the industry has compromised on many issues for political reasons. The Rs 3,000-crore seed industry is spending about 10-12 percent on R&D activities. It is necessary to have a strong IP regime to protect the newer technologies. Patents should be given for genes and microbes." - Paresh Verma, head, BioSeed Research India "The working system is in place. But it is a long way to go. There is need for optimizing the time while doing field trials. The process of agri testing should be streamlined. The present system of event-to-event approval in GM crop is challenging for all. Private companies should need to look at their priorities and should be left free from the government hitches. The real problem is quality of the food crop and the yield." - V Ram Kaundinya, managing director, Emergent Genetics "We have to arrive at a consensus by taking the views of all the stakeholders of the industry and also try to convince all the people involved to solve the problem of shortage of food supply. There should be transparency in the whole process. At present the industry doesn't have a clear data on Bt cottonseeds." - Dr Sridhar, Venkataraman, group leader, Avesthagen "The choice of selecting the right technology should be given to farmers. The people will learn to use the new technology but it will take time." - Dr PK Seth, CEO, Lucknow Biotech Park ]]> <![CDATA[Panel Discussion 2]]> https://biospectrumindia.com/news/95/1875/panel-discussion-2.html https://biospectrumindia.com/news/95/1875/panel-discussion-2.html Tue, 11 Oct 2005 15:16:00 +0530 Panel Discussion 2 Panel Discussion 2 Biopharma: Globalization and partnership opportunities Suchitra Ella, Rashmi Barbhaiya, Dr SD Ravetkar, Dr M Vidyasagar, KV Balasubramaniam and Mahima Datla After Mashelkar Report, what more needs to be done? Should a collective "India story" be sold to the world on BioPharma? Can partnerships and alliances be fostered within Biotech industry to bid for big global orders? Should the industry focus on niche areas? Should companies have products or services? What should be the ratio? Dr M Vidyasagar, executive vice president and head, Advanced Technology Center, Tata Consultancy Services, moderated this panel, which comprised Dr SD Ravetkar, senior director, Serum Institute, KV Balasubramaniam, managing director, Indian Immunologicals, Mahima Datla, senior vice president, Biological E, Suchitra Ella, Director, Bharat Biotech, and Rashmi Barbhaiya, Founder Director, Advinus. "The present Biotech industry is as was IT industry in 1990. Biotech now can use the brand "India" because of the success of IT industry. Biotechnology industry has been benefiting from the government unlike IT industry in its initial years. Hence it needs strong lobbying to get the things in place. Industry has to train its own people. Sponsorship is an excellent approach to tap the right talent." - Dr M Vidyasagar, executive vice president and head, Advanced Technology Center, TCS "We need to create a good mindset factor to develop and sell quality products. We are lacking in various issues such as documentation, validation, quality aspects and poor understanding of the subject related to regulatory issues among the inspectors who are giving the final approvals. These topics should be addressed. The government should also work with time bound limits and implement the recommendations of the Mashelkar Committee report to help the industry. The multinational companies are looking at India and they do come to India. - Dr S D Ravetkar, senior director, Serum Institute of India "The companies need to look at leveraging research, manufacturing and also marketing capabilities. They should stop looking at licensing. We have a direction in place. And lot more efforts should be put in to meet the international standards and to reach the target of $5 billion mark. The game is not easy as it is seen from outside." - KV Balasubramaniam, managing director, Indian Immunologicals "Integrate all the regulatory bodies so that we can have in place a single window clearance system. We should also have federal type of system like the one in the US, Europe or in few developed countries instead of dual systems of controlling such as federal and state control." - Mahima Datla, senior vice president, Biologicals E Ltd "We need to step up and catch up to move ahead of competitors. Clarity is required from day one and also understanding of the regulatory mechanism, technologies, handling of manpower issues, as students are not aware of what is happening in the industry. We need one brand umbrella like "BioIndia" to showcase India as one country to market our products. The country has tremendous potential in clinical trials, new molecules development, vaccines and therapeutic products for growth." - Suchitra Ella, director, Bharat Biotech International Ltd "There are opportunities in genomics, contract research and new drug discovery system. We have to think about the present infrastructure before setting up the units. It should be innovative research. There is a need for creating a forum to lobby for India to sell its story in the international market. And also an action plan has to be developed to achieve the goal of reaching $5 billion mark. IPR is still an issue to establish relationship with global pharma or biotech companies." Dr Rashmi Barbhaiya, CEO Advinus Therapeutics Pvt Ltd ]]> <![CDATA[Panel Discussion 1]]> https://biospectrumindia.com/news/95/2771/panel-discussion-1.html https://biospectrumindia.com/news/95/2771/panel-discussion-1.html Tue, 11 Oct 2005 15:14:00 +0530 Panel Discussion 1 Panel Discussion 1 Fostering Better Industry-Academia Collaborations Prof. S Krishnaswamy, DY Rao, Dr PK Seth, Sarath Naru, Dr D Balasubramanian, Vijay Chandru, Dr Ajeet Verma and Dr Gita Sharma. Can industry leverage existing capabilities in public funded research units? How about a Bayh-Dole Act for India to spur academy-industry collaborations? How to buy the Inventor's commitment for full-scale commercialization? Do research labs look at industry as "milch cows" to achieve revenue objectives? Dr D Balasubramanian, Biotech Advisor, AP government and director, LV Prasad Eye Institute and Sarath Naru, CEO, APIDC-VC, jointly moderated this session to explore the ideas to make a new beginning. Dr PK Seth, managing director, Lucknow Biotech Park, Dr Gita Sharma, chief scientific officer, Magene Lifesciences, Dr Vijay Chandru, managing director, Strand Life Sciences, Prof. S Krishnaswamy, managing director, Animal Biotech, Dr Anil P Kariath, managing director, Sartorius, Dr DY Rao, head, technology networking and business development division, CSIR, and Dr Ajeet Verma, Amity Biotech were the panelists. "Industry and academia should engage in regular interaction. Academia needs to communicate about some of its ongoing projects to the industry and explore how they can help the industry." - Dr Ajeet Verma, Amity Biotech "The academia should prioritize their activities and focus on need-based projects so that public funds shouldn't go wasted. They should also have timeline commitment. Industry should give a regular feedback to the research organizations on the projects the latter are working on." - Dr Gita Sharma, chief scientific officer, Magene Lifesciences "Although we see a change in industry and academia relation, still a lot needs to be done. Offering incentives will encourage the scientists to take up more projects." - Prof. S Krishnaswamy, managing director, Animal Biotech "Things are changing at both government level and at the industry side. In the last five years Rs 270 crore has been disbursed under NMITLI, a largest public private partnership scheme as soft loan to various companies. We have about 37 projects at various stages of development. There are already two products as a result of this initiative. So there are a lot of advantages if both industry and academia work together." - Dr DY Rao, head, technology networking and business development division, CSIR "A partnership with the academia or research organization will give a lot to the industry. The industry needs to find out the list of projects and place their requirement to them." - Dr P K Seth, chief executive officer, Lucknow Biotech Park. "The Bayh Dole Act for India is necessary but not sufficient. It only helps in developing a patenting culture. We have to look beyond the Act and a workable proposition where commercial benefits have more weightage." - Prof. Vijay Chandru, chairman, Strand Life Sciences "At present industry and academic research are running parallel. They have to converge or else the industry will incur losses. Organizations like ABLE should come out with a list of technologies available at different research institutes for transfers too for the benefit of the industry." - Dr AP Kariath, managing director, Sartorius India "Industry should create or generate a fund pool to promote research activities among students community. Industry should look at sponsoring couple of students at PhD, postdoctoral studies without any strings attached." - Dr Rashmi Barbhaiya, founder, Advinus Therapeutics "The Bayh Dole Act is necessary but not a sufficient condition. There should be a mentor in lab. Further, the best means of industryâ€“academic collaborations include licensing, joint venture, hiring, meeting at conferences, communication, etc. The academia needs a mentoring approach and also a mentor in a lab. The industry can also share ideas with research organizations, which are of commercial interest," - Sarath Naru, CEO, APIDC-VC "Talents are available but are well hidden. Academia should look at how to showcase these talents. The academia should consider the commercial values while taking the projects." - Dr KK Narayanan, managing director, Metahelix ]]> <![CDATA[Cross Talk]]> https://biospectrumindia.com/news/95/1413/cross-talk.html https://biospectrumindia.com/news/95/1413/cross-talk.html Tue, 11 Oct 2005 15:13:00 +0530 Cross Talk Cross Talk Kapil Sibal readily agreed to an interactive session, Cross Talk, to field questions from a group of CEOs. The Talk, which lasted for about 30 minutes, saw a host of questions about the industry being answered deftly and crisply by the erudite minister. It was anchored by BioSpectrum publisher, Pradeep Gupta. Excerpts from the Cross Talk. Pradeep Gupta, managing director, CyberMedia (India) Ltd You have said in your interview with BioSpectrum that 'Biotech is the best batsman in your S&T team'. How do we make the best batsman into a master blaster? Also, as every team has a best batsman, how do we make it the best team in the world? When I said biotech is the best batsman in my team, I assume biotech as just one entity. There are 10 others players who will also have to make biotech work. For the team to succeed and the best batsman to be a master blaster, we need all those 10 players to contribute. Those 10 players include the government's tax policies, the procedural things that need to be put in place, GEAC, etc. Unless all that happens, the master blaster will get a tendon injury. What we need is people working together. And that is why I have spelled out the road map that is needed to make the Indian biotech successful. We need the environment, the funding, a Bayh-Dole kind of legislation, tax concessions, biotech parks, access to cell lines and biological material. Besides we need start-up companies to invest more in R&D. If all that works, biotech will be the best batsman in my team. Varaprasad Reddy, managing director, Shantha Biotechnics You clarified that the streamlined regulatory system will be in place by November. But like the entrepreneurs who are accountable to the financial institutions and stakeholders on timelines, will the regulatory institutions also be made accountable? There are four kinds of biological material-no risk, low risk, medium risk, and high risk-handled by the industry. As far as the "no risk" to "medium risk" categories are concerned, there will be no problem after the recommendations of the Mashelkar Committee come into place. And the Department of Biotechnology (DBT) is going to handle it. So as and when the request is received, clearance is given. 'If the request is today, it should have been cleared yesterday.' That is the way in which we have to function, if we as a nation have to move forward. We (the government) must function more like the corporate sector and you (industry) must have the concerns of the public in mind just as we do. Unless that marriage takes place, nothing is going to move forward. So if your request comes, we need to move forward and once you have the material, you must use that ethically in the public interest and do all the things that are right in order to contribute to the well being of the nation. I can promise you that from my department. I cannot talk about anybody else. There is no question of timelines. It will happen immediately. As far as the "high risk" stuff is concerned, we have to go through certain approvals and that has to be done. Agreed timelines will be followed. Will your ministry take steps to get various biotech drugs and vaccines included in the universal immunization program? The universal immunization program in the country is being conducted for vaccine preventable diseases. Drugs are not included in this program. The Ministry of Health and Family Welfare considers inclusion or exclusion of different vaccines through a special mechanism of consultations with various stakeholders. I am willing to help you in the process by requesting the health minister to consider your demand. But from my side I am willing to help you in every way. KO Isaac, CMD, ABL Biotechnologies, Chennai You have answered several questions related to the diagnostics sector. Cost is something that we are concerned with. Can something be worked out to manufacture diagnostic kits within the country in an affordable way? I support you in that effort. I want to help you. The issue of making duty free import of reagents and components in preparation of various diagnostic kits within the country has been debated in various forums. The Ministry of Science and Technology, in general, and the Department of Biotechnology, in particular, have been recommending duty free import of diagnostic reagents to the Department of Revenue from time to time. However, any structural changes in duty rates for specific commodities require all the relevant information from the industry. You have to come and give me specifics. 'The industry also needs to be a little more proactive, every time you expect the government to be proactive.' Subash Lingareddy, president, Ocimum Biosolutions, Hyderabad Is there any plan to develop specific capability clusters in India? For example Bangalore could be the 'Proteomics cluster' and Hyderabad could be the 'Genomics cluster'. The secretary of DBT has talked to me about this and he wants to emphasize on proteomics and that discussion can be carried forward. It is a welcome step. Paresh Verma, director, research, BioSeed Research India, Hyderabad What are the steps being taken by the government to accelerate the availability of approved technology in new generic background? I am talking about the technology that has already been assessed for biosafety risk and approved as safe. With the new procedures that are going to be put in place, all that is going to be streamlined. You should not have a problem on that. The government has approved 20 Bt cotton hybrids for north, central and south zones of the country, with diverse genetic backgrounds. This approved technology is being sub licensed to more than 20 seed companies and all of them are in the process of evaluating their best Bt cotton hybrids suitable for different agro-climatic zones. Further several hybrids with two new Bt cotton technologies are also under large-scale evaluation. In coming years, more and more Bt cotton hybrids with diverse genetic backgrounds would be available to farmers. It must be remembered that this is nascent industry and in couple of years, things will be further streamlined. The concern of the industry in general is that we are looking at a particular variety or hybrid as a biotech product, rather than biotech trait as a biotech product. Can we do something? I cannot answer that because it has biosafety implications and I am not qualified to answer that as I do not know if the trait by itself is enough to take care of the biosafety considerations or not. I will go by the experts' opinion. Do we have the necessary framework to handle the GM food crop production in downstream applications? As on date, no GM food or GM food crop has been approved for commercial purpose by the government. No GM food has been permitted for marketing also in this country. However, Bt brinjal is undergoing food, feed and environmental biosafety evaluation. Apart from brinjal, cereals and other food crops like rice, pigeon pea, tomato, brassica, cauliflower, cabbage and okra are in various stages of biosafety evaluation. The major issues involved with the GM crops are to address human and animal health safety apart from environmental safety. As regards to the regulatory process for downstream food crops, meet me and suggest what should be put in place. We will do the necessary spadework within the government to ensure that that is done. ]]> <![CDATA["My dream is not just the $5 billion, but much more."]]> https://biospectrumindia.com/news/95/2226/my-dream-is-not-just-the-5-billion-but-much-more-.html https://biospectrumindia.com/news/95/2226/my-dream-is-not-just-the-5-billion-but-much-more-.html Tue, 11 Oct 2005 15:11:00 +0530 Sibal Talk Sibal Talk "My dream is not just $5 billion, but much more," Kapil Sibal, Union Minister of State for Science & Technology and Ocean development, speaks about the progress made in biotechnology in the last one year. It was on October 21, 2004 that Sibal met some CEOs in Bangalore, who came under the aegis of ABLE. In the course of that meeting, Sibal told them what was there on his agenda. Exactly, 11 months have passed after that meet. Sibal, the chief guest for the first ever biotech CEOs summit organized by BioSpectrum, chose the platform to present his report card. "The question to be asked is have we made any progress in the last 11 months? If it all what is the progress? Where do we stand? Where does the industry go from here? Where does the government go from here? And what do we plan to do in the next one year or so to take this dream of ours forward that by 2010 we should be a $5 billion industry." Sibal was unambiguous is identifying his performance matrix and his goals moving forward. We present to you the insights of Sibal's and the government's thinking on the Indian Biotech Dream. 1. I wanted a Biotech National Policy in place. 2. I wanted India to comply with the global regime on IPRs 3. I wanted a framework for Academia-Industry interaction 4. I wanted to address procedural issues of regulation for approval of genetically engineered products 5. I wanted the biotech industry to get concessions and exemptions like the IT sector. 6. I wanted to set up of a large animal facility. This was what Sibal stated in October 2004. So what has been the progress! Objective 1: National Biotech Policy Status: Likely to get Cabinet approval by December 2005 "In March 2005, we had a national biotech development strategy in place. We put it for comments on our website. And the latest news is that we are on the last leg of interactions in Chennai and Ahmedabad. After that the draft strategy will be up for the government approval which means it will go to the Cabinet. I expect this to happen in the next couple of months." So we are going to have a national biotech development strategy, which offers huge concessions to the industry and gives a road map as to what's going to happen in the years to come. How will the human resource be developed? How are industry and academia going to interact with each other? What kind of support system will be put in place? What kind of tax, excise duty, and other concessions are to be put in place? How will the biotech parks be set up? How will we train academia to start looking at multi-disciplinary courses to teach individuals? All that is set out in the Biotech Development strategy. This objective is well on the road to be accomplished and we will probably have the Cabinet approval in the next two months. Objective 2: Comply with the global regime on IPRs Status: Product patents regime in place "As far as the second objective, namely complying with global regime is concerned, the product patents are in place. In fact, there was an article in The New York Times stating that the Indian government is sold out to multinationals. An article like that and that too in the The New York Times indicates we are doing the right things. That problem is behind us." Objective 3: Framework for Academia-Industry interaction Status: Legislation on the lines of the Bayh Dole Act is expected "As far as the policy framework for Academia-Industry interaction is considered, we are all at the moment working for a legislation on the lines of the Bayh Dole Act, in which we want to ensure that the academia, the national labs, and industry collaborate with each other and the IP generated pursuant to that is shared by those who contribute to the generation of the IP. Of course, we will not do everything that the Bayh Dole Act does. We will try and improve upon this. I do believe that those in academia and industry to whom the funds are given must own the IP and unless they have ownership rights or believe that they have the ownership rights, they will not be able to create globally competitive products." "We are not sure if that framework will come in the form of a legislation or an executive guideline. But my personal preference would be to legislate so that there would be no discretion left in any collaboration that takes place between academia, industry, national labs and the government." "Funding will be provided by us. But the question that arises next is who owns that R&D? That should depend on the nature of the product, the nature of partnership and the nature of the R&D. This is done best by partners who are partnering in the enterprise rather than intervention from the outside. The government should not have any part in it. That's going to happen soon. I assume that by the Budget session of 2006, we should have the kind of legislation based on the Bayh-Dole Act passed." Objective 4: Procedural issues of regulation and genetically engineered products Status: Mashelkar Committee recommendations to be in place by November "As far as the procedural issues on regulation and approval of genetically engineered products are concerned, we have the Mashelkar Committee Report now and the Report clearly points to a single window kind of clearance. The multi-approval approach, the kind of GEAC approach, has been rejected. We will soon have the support of Ministry of Environment and Forests for the Mashelkar Committee recommendations. And you will have that in place by November. That is a huge step forward. We also believe that the issue of approval should be decided in the Department of Biotechnology (DBT) rather than anywhere else. Hopefully we should be able to do that." "One of the concerns that the industry has and rightly so is the availability of cell lines. That is a matter of great concern and of vital importance to the industry. I understand that the cell lines that are available in India will not serve the next generation R&D that the industry wishes to do. Therefore most of the industry will have to rely upon the cell lines that are imported and with the present GEAC kind of procedures, it is very difficult to do that. The delays are so large that it is uneconomical to go through that procedure. We have now decided, and that is again the recommendation of the Mashelkar Committee Report, that 90 percent of all cell lines will be imported without any problems. That is you can import them directly. There will be no questions asked and the permission will be given by the DBT. It's only the 10 percent, which are complicated, that would need to go through the approval system because of biosafety considerations. That approval system will be far more streamlined than it is at the moment. These two would happen by November." Objective 5: Concessions and exemptions like that in the IT sector for the BT sector Status: Mostly in place "As far as the exemptions like the tax and other exemptions are concerned, we do have most of them in place. We are going to set up biotech parks in 20 states in the country. We have already granted 150 percent weightage deduction on R&D expenditure. We have a single window application-processing proposal. The biotech industry got benefits under the budget this time for export oriented units. These have now been extended to the biotech parks. We now have 100 percent FDI permitted through the automatic route and biotech units are exempted from income tax and export proceeds have to be realized within 10-12 months. And biotech parks are allowed to retain 100 percent export earnings in the EEFC (Exchange Earners Foreign Current) amount. So all those concessions, which are by and large necessary for the BT industry, are already in place." Objective 6: A large animal facility. Status: Feasibility study on "As far as the large animal testing facility is concerned, it will be set up in Hyderabad. The feasibility study of this facility has started." The Road Ahead Sibal's Five Point Action Plan The government, by and large, has been working according to the promises that have been made and as per schedule. But the question is how do we take $1 billion industry to a $5 billion industry by 2010? "I personally think that the exponential rate of growth of the biotech sector in the country (the target of $5 billion) is a target not of doers and dreamers but a target of those who think conservatively. I believe we can do much more than that. But we have to do certain things to achieve that target." A system to promote public private partnership "We have to put in place a system that can support R&D at the pre-proof-of concept stage and carry on through the stages of manufacture and sale of the products. We need continuous public-private partnership. It should happen as a chain of things. For example, there should be pre-proof-of-concept stage funding in the nature of grants to anybody who wants to set up a business incubator or a start-up company. There the government of India and the biotech department has already decided to give up to Rs 50 lakh as grants, free of any strings attached. Anything more than that amount will be given at a nominal rate of interest, which will not affect the company." "Once the proof-of-concept is shown, similar concessions need to be further extended. That policy has been cleared. You will soon see advertisements in the newspapers on this so that you can apply for that facility and get the grant." "Once the proof-of-concept stage has been reached, we move to another kind of partnership under the NIMTLI program and that partnership allows any department or a CSIR lab or anybody else to get money at a very low rate of interest. The sums are much larger. So that public-private partnership will continue to be operated." "Once you reach a stage where the product would be manufactured, you can go to the Technology Development Board (TDB) within the Department of Science and Technology. TDB will then partner with you to actually do the pilot project and set you off to the market place. You should realize that we have in our mind the zeal to partner with you at every stage of your requirement-pre-concept through the pilot project and up to sale of the product. If we achieve that we are then on the road to the kind of $5 billion hopes we have for 2010." Evolve best practices "We need the best practices in place to carry out clinical trials. DBT is planning to set up a Translational Center for Clinical Research Organizations (CROs). This is to facilitate the link between lab research and CROs. A Translational Center is a scientific link between laboratory research (clinical trials) and human trials (actual clinical trials). It is not enough for all of us to become familiar with the best practices, but do trials, which are acceptable to the international community, as world class. This in turn will attract FDI to India. A large number of trials are already taking place in India, but these trials are taking place because MNCs believe these trials are far cheaper in India and we have the human resources and capabilities to actually go through those trials, though we do not have the best practices in place in India at this point of time. This institute (the Center) that we are going to set up is going to partner with you to establish the best protocols and practices for trials, which will be acceptable throughout the world. I think that's an area where huge investments are going to come in. That's a strategy that we need to evolve." Industry also needs to gear up "The Indian biotech sector is a nascent, but is on the course of being mature. There are huge possibilities. There are 280 companies and the turnover of $1 billion is done by 20 of them or 60 percent of that turnover is by 20 companies. Now that means 260 companies, which are small, have huge potential for growth and this potential ultimately has to be tapped. And if we are able to partner with them in the manner that I suggested, then perhaps we can generate the kind of growth that you are hoping. And if that growth spreads beyond the 20 to 100 or 120 companies, then the $5 billion target is really conservative." "But the fact is that the industry also needs to gear up. It's true that we are going to partner with you and also fund you, but the expectations from us are also huge. We expect the industry to invest in R&D in a big way. At the moment they are not investing in R&D as they have a lot of constraints. Most of them are very small enterprises and in times to come they will invest in R&D. For example, in Israel, there are about 3,000 companies, which are newly set up. That has been done in the last 10 years. All those 3,000 companies are doing fabulous R&D. But Israel has a disadvantage. Though they are doing R&D, they do not have any manufacturing facilities nor do they have the human resource or the capital. We have a great advantage of being distinctly strong in manufacturing and on the pharma side. So what we need to do is to strengthen our innovation of new companies." "That innovation will be strengthened only if one, we partner with you and two, some venture capital comes into the market. Today companies in the US are looking to India to actually invest through the venture capital. You ought to take advantage of that, but please don't ask us to fund you for your travel abroad. We can fund you for your R&D. We cannot fund you for your 'Bloody Marys'. So by and large this is the road ahead of us." Environment for global partnerships "I know for the fact that nobody outside the country can even think of doing Phaseâ€“III trials in India. A lot of companies have told me that protocols need to be set up in the country. When I went to the US, one of the things that I told the US government was that we want the FDA to collaborate with the drug controller in India to set up those protocols for the purpose of world class clinical trials, which will even be accepted in the US. We should formulate procedures, which will not make the processes equally complicated or expensive in India. We will have to accept the protocols in principle and devise our own methodologies to actually implement that. The US in principle has agreed to that." "A lot of the private companies in both the countries are unwilling to part with the biological material at this point of time. I spoke to US government on the issue of import of biological material. I stressed on the need for setting up of protocols on bringing the biological material into India and in turn this can be licensed to who ever wants it subject to conditions that take care of the concerns of the companies in both the countries. This has also been agreed upon in principle. I wish to inform you that I am going to the US on October 17, 2005 to sign an umbrella science and technology agreement and I am going to carry forward the biotech and nanotech dialogue with the US administration to ensure that most of the things that I talked about are actually put in place in India so that the industry here is helped in the process of the growth." Industry needs to be proactive "I am delighted to be here. But you need not wait till the next summit to give me your agenda. You should set up a day to meet me in Delhi every two months or so. So that we sit across the table and find out how the problems enunciated by you have been dealt with and see what we are lacking and how we can go forward. That is a far more effective way of doing things than coming and making a statement and going back without having on table what you exactly want. I would therefore suggest you to give me on a piece of paper the points on which action needs to be taken." "I know for example people are talking about exemptions on diagnostics kits. They say kits manufactured here are not yet given concessions. The government of India perhaps wants from you the list of reagents that can be exempted. But if you give a whole volume of reagents, you are not going to get the exemptions. So talk within you fraternity, limit the number of reagents on which you want the exemptions, give the exact list. We will move forward. So you too have to work at your end and help us in helping you. "I took this as an example as that was the thought that came into my mind because this issue was raised by me. I talked to the finance minister. Nobody from the industry got in touch with me since October 2004. I am myself raising the issue telling you all what the problem is. Now if you people (two-three) were to meet me saying this is what we need and this is the new problem that has come up. This interaction five-six times a year will also help us deal with the problems that emerge while moving forward. That is a better way of dealing with the issue." "Come to me every two months or so with an agenda telling me in advance what the previous agenda was and what were some of the decisions taken. I can then tell you what was implemented and what was not or at what stage it is in. We want the government to be completely transparent. We want to tell you where the difficulties are and where we can help you and where we cannot or where to approach for somebody else's help. All these things are important. And I think this kind of a system is important for the industry and government to work together." But my dream is not just the $5 billion, but much more. You are the sunrise industry of the country in the early part of this century and I think you will make it possible to take this country forward and achieve the growth rate of 8 percent of GDP that we have been talking. ]]> <![CDATA[BioSpectrum Biotech CEO Summit]]> https://biospectrumindia.com/news/95/1987/biospectrum-biotech-ceo-summit.html https://biospectrumindia.com/news/95/1987/biospectrum-biotech-ceo-summit.html Tue, 11 Oct 2005 15:08:00 +0530 BioSpectrum Biotech CEO Summit BioSpectrum Biotech CEO Summit N Suresh, editor, BioSpectrum, Kapil Sibal, minister of state for science and technology and Pradeep Gupta, managing director, CyberMedia (India) Ltd at the Summit. India has a biotech agenda. "To be a $5 billion industry by 2010." To make this possible all the stakeholders of this sector need to have a common goal. The government, industry, academia, public research, and funding agencies all need to work hand in hand. They need to be competitive, collaborative, and cohesive. They need to strike the right balance between public welfare and company welfare. BioSpectrum, in its efforts to promote the biotech industry, launched "Biotech CEOs Summit", a first of its kind platform in India to bring together the various stakeholders of the biotech industry to a common fold. Conceived as an annual feature, the first ever "Biotech CEO Summit" was held in Hyderabad on September 23, 2005. Over 60 CEOs, heads of top biotech research centers, policy makers and VCs from across the country participated in the daylong event discussing the "The Strategy to Achieve the $5 Billion Revenue Target by 2010." The Union Minister of State for Science & Technology and Ocean development, Kapil Sibal, inaugurated the maiden "Biotech CEOs Summit". He shared candidly the thinking of the government, the progress that it was making, the expectations that the government has, and how he wishes to take forward the dream of "$5 Billion Biotech Industry by 2010" a reality. Sibal also engaged himself in a cross talk with the industry. After the inauguration, industry leaders explored the theme in detail through four panel discussions. The Panels deliberated on: The Research Road Map: Fostering Industry-Academia Partnerships Leveraging India's BioPharma Strengths through Global Partnerships Making India the "Hub of Global Clinical Research" and "Biotech Laboratory of the World" India's role in feeding the world through transgenic crops In the ensuing pages, we present the key messages, suggestions, and action points that have come out during the discussions for the benefit of the industry as a whole. The take away clearly from the Summit deliberations was that "things are falling into place". And the challenge now is moving forward. BioSpectrum identifies the 'to-do' list for the industry and government. Three Things the Industry should do: United biotech front through collaborations and alliances, emphasis on affordability of biotech products Healthy competition and self regulation Sell the "India Biotech Story"; every CEO is an Indian Biotech brand ambassador Three Things the Government should do: Efficient regulatory system, harmonized international standards and financial support to early-stage biotech start-ups An Indian Bayh-Dole Act to spur innovations in biotech research in academia National and global awareness campaign to promote the " Indian Biotech Advantage" in manufacturing, clinical trials and research. Support to biotech companies for participation at global events. N Suresh ]]> <![CDATA[Sartorius India launches new purification products]]> https://biospectrumindia.com/news/95/2775/sartorius-india-launches-new-purification-products.html https://biospectrumindia.com/news/95/2775/sartorius-india-launches-new-purification-products.html Tue, 11 Oct 2005 14:59:00 +0530 Sartorius India launches new purification products Sartorius India launches new purification products Anil P Kariath, managing director, Sartorius India (extreme left) along with the senior management team of Sartorius. In September Sartorius launched its two products Sartobind (Membrane Adsorber) and Virosart CPV (Virus Clearance Filter). The senior management team from Sartorius, John Pleasants, director, technical support, Asia Pacific, Dr Uwe Gottschalk, vice president-purification, Sartorius AG, and Dr Christian Manzke, head of application development, Sartorius AG, were in Bangalore and they along with Anil P Kariath, managing director, Sartorius India, shared Sartorius' plans and thoughts with Ch.Srinivas Rao of BioSpectrum. What is the concept of this new portfolio of purification products? Biomanufacturing is characterized by the fact that fermentation development is setting the pace in terms of productivity through cell line, media, and reactor development. And today manufacturers are under pressure to look at their performance on a cost per gram basis. Advances have been made in upstream processing and productivity gains have been made in disciplines such as batch culture and fermentation, even though industrial biotechnology still uses dilute solutions and large volumes. The limiting step in production was seen to be downstream processing. Realizing the need to provide the biopharmaceuticals industry with an integrated portfolio of technology products, we have worked to build a comprehensive and integrated solution. This includes the provision of fermentation, separation and automation systems as well as training and validation support. Our purification portfolio comprises powerful technologies for cell removal at high biomass, bioseparation strategies on the basis of membrane adsorbers and an orthogonal platform for the reliable removal of pathogens and other process-derived contaminants. These are the underlying attributes of Sartorius Purification Technologies' innovations in the downstream processing arena. Is there an opportunity for your new purification products in India as the industry is too small here? The market scenario exists into two areas-in protein therapeutics by self development and in the conventional products like vaccines. This capacity for conventional vaccines has improved 10 times. With the opening up of African market, there is a big gap for supply and companies who use new technologies can expand faster. India may be a typical small biotech world. But tings are moving forward at a rapid pace. Several companies are working in the monoclonal antibodies area. Recombinant monoclonal antibodies (Mabs) have continued to increase in importance as therapeutics for the treatment of cancer and autoimmune diseases. But, the problem is large scale production of these molecules and requires a good manufacturing process. Besides, the biotech sector is moving from antibiotic expression to antibodies. So the Indian is an important customer. Further, India is the second most important market, besides Japan. The customers here are relatively open minded. Hence India is undoubtedly a big opportunity. Further within our organization, India is one of the very few places outside of the US, which has people of caliber to support and talk to the customers. "We are bringing out specialized products for Proteomics research" Navneet Trehan, director, India Operations, Axygen spoke about the new developments taking place at Axygen. Which are the new products being launched by Axygen? During the past few years Axygen R&D team have been actively involved in research work for bringing out newer versions of products, which can be used in genomics and proteomics research. Now we are ready to launch a whole new range of purification kits DNA Markers and Crystallography products. The isolation and purification kits include plasmid, miniprep, mediprep, maxiprep kits (known as Axyprep), multisource genomic DNA, blood genomic DNA, body fluid viral DNA and RNA, PCR clean up and a range of RNA kits. We are also bringing specialized products for proteomics research, as this is where the future lies. Our protein crystallization plates have already been launched and the other products will soon be available. The continuous research efforts of our core research team based in Union City, California, has assured us that many new products will be available in a short span and they are going to be in line with the best. So with an initial focus on lab plastic consumables, we have expanded our product range to biotech equipments/instruments and now to kits. Axygen acquired Labnet International last year. How has it benefited Axygen? The takeover of Labnet was the biggest acquisition of Axygen till date. Now we have finalized the takeover completely and Labnet International Inc now functions as a group company of Axygen. The product range of Labnet is very wide and its instruments range alone consists of not less than 70-80 products. Some of the important products include centrifuges, liquid handling systems, incubators, water baths, electrophoresis units, a range of shakers and rockers and hybridization ovens. Today there are very few companies in the world that sell such a broad range of products under one roof. Now by virtue of our wide distribution network in over 80 countries, the Labnet products are easily accessible to all our customers. By the end of 2005, we are aiming to increase our international turnover by more than double. In India, Labnet was not very well represented, but after its acquisition, its first year in the country was very successful. We have done about 140-150 Labnet installations in India in just one year. Axygen also represents several foreign principals in India. How is this segment of its business growing? We are proud of our prestigious channel partnerships like Corning, Nichiryo, Princeton Separations, Vitlab Gmbh among others and our commitment, dedication and devotion to them is 100 percent. That is the reason why the combination has grown many folds in last many years and we expect to grow further because our strengthened ties have given us better confidence. As a whole hearted commitment to our customers for giving after sales service we have come out with a full fledged calibration and repairing facility for Nichiryo range of products supported by all spares and technologies. We will be in a position to give complete service support within 4-5 days to all our customers. This facility has been made operational since the first of September. Biotech India to distribute RayBiotech's Antibody Array Vinaya K Dubey, director, sales and marketing, Biotech India, elaborates on the company's new protein array product. What are the new products added to the company's existing portfolio? In 2005, Biotech India got the distributorship of products from the US based RayBiotech, Inc., the pioneer company in protein array. The company's Cytokine Antibody Array is expected to see great demand in the current era of proteomics. Incidentally this is the first commercially available protein array system in the world. What are its salient features? Using this array system, scientists can easily, rapidly and accurately identify the expression profiles of many cytokines in a single experiment. In addition to this, Cytokine Antibody Array doesn't require special equipment and available for human, mouse and rat. It is affordable and cost effective enough for routine use. Only 100 µl of a sample is adequate for detection of over 120 cytokines. This system is highly reproducible, specific, sensitive and can detect most proteins at picograms levels. This system speeds up your discovery process by conserving precious samples and saving time and money. Rolly Dureha ]]> <![CDATA[Varda Biotech offers Taq DNA Polymerase]]> https://biospectrumindia.com/news/95/1111/varda-biotech-offers-taq-dna-polymerase.html https://biospectrumindia.com/news/95/1111/varda-biotech-offers-taq-dna-polymerase.html Tue, 11 Oct 2005 14:58:00 +0530 Varda Biotech offers Taq DNA Polymerase Varda Biotech offers Taq DNA Polymerase Varda Biotech's latest offering is Taq DNA Polymerase. Varda Biotech Taq polymerase (VerTaq) is a recombinant thermostable enzyme which consists of a single polypeptide chain with a molecular weight 94 kDa. It is highly processive DNA polymerase lacking 3-5' exonuclease activity. The enzyme exhibits highest activity at a pH around 9 with optimum temperature of 72 °C. The Taq polymerase is stable during prolonged incubations at elevated temperatures (95 °C) during PCR reactions. The enzyme is highly purified and is free of non-specific nucleases and any trace amount of contaminating DNA. The stringent quality control of the enzyme assures outstanding batch-to-batch consistency eliminating testing of each new lot of Taq polymerase. The enzyme is supplied at 3000 units per mL along with optimized 10X reaction buffer for most PCR applications ranging from 100 bp to 4 kb of the target DNA. The enzyme is routinely tested for RT-PCR, RAPD and cycle sequencing. It is available in bulk pack and custom packs. For details contact: info@vardabiotech.com, mahesh@vardabiotech.com JH Bio Innovations markets AlphaDigiDoc RT AlphaDigiDoc RT is the economical gel documentation system from Alpha Innotech Corporation that provides real time imaging. Ideal for individual users with a limited budget the AlphaDigiDoc RT can utilize an existing computer or transilluminator. The new AlphaDigiDoc RT digital imaging system provides easy-to-use real time sample positioning with a compact space requirement set at an affordable cost that fits most laboratory budgets. AlphaDigiDoc RT is paired with the AlphaEase FC Imaging Analysis software that combines unrivaled ease of use with a comprehensive set of documentation, analysis and image enhancement tools. Bangalore-based JH Bio Innovations has been marketing this product of Alpha Innotech Corporation in India. For details contact: sales@jhindia.com, info@jhindia.com Whatman offers ArrayVision ArrayVision is a flexible software package from Whatman that has been developed for the quantification of gene expression arrays. It is suited for the quantification of proteins. It provides rapid and automated analysis for array images in a few easy steps. The software is designed with maximum flexibility to suit the needs of any size lab and uses configurable protocols to suit any array format. When ArrayVision is used with FAST Quant, data can be anlaysed within minutes after scanning to provide quantitative results. ArrayVision FAST includes templates designed to fit FAST Quant, and can also be used to analyse scanned Serum Biomarker Chip slides. For details contact: whatmanp@vsnl.com Biodigital offers Biochrom's techs to Indian firms UV/Visible Spectrophotometry is a fundamental analytical technique. Together with suitable sample handling accessories, it is used in laboratories for absorbance and transmission measurements of samples in all application areas. Biochrom, using its Ultrospec, GeneQuant, Libra and WPA brand names, manufactures and extensive range of attractive UV/Visible products and accessories. Amongst other technological advances, these instruments feature PTR (Press to Read) capability, which dramatically extends the lifetime of the source lamps. Libra S21 and S22 are simple-to-use instruments with advanced performance, incorporating xenon lamp technology for longer source lifetime and lower maintenance costs. A further benefit of this design is optical noise compensation to improve signal to background measurements. Instrument Performance Validation (IPV) is included as standard, and will benefit any laboratory that needs to prove the quality of their results. In addition to measuring absorbance, transmittance and concentration, they provide a standard curve routine for analyte determination. Wavelength scan, absorbance changes with time, reaction rate determinations and standard curves can be displayed as graphics and printed out. User defined equations can be entered using multi-wavelength mode and methods can be saved in separate operator folders. The instrument can be upgraded for more sophisticated applications, as well as data manipulation, with Acquire Software and a PC. Biodigital India has been acting as a distributor for Biochrom's products in India. For details contact: mail@biodigitalindia.com ]]> <![CDATA[The Mashelkar Report on Recombinant Pharma]]> https://biospectrumindia.com/news/95/2428/the-mashelkar-report-on-recombinant-pharma.html https://biospectrumindia.com/news/95/2428/the-mashelkar-report-on-recombinant-pharma.html Tue, 11 Oct 2005 14:56:00 +0530 The October Wish List to Kapil Sibal The Mashelkar Report on Recombinant Pharma Highlights Task force takes 90 percent of LMOs out of GEAC purview National Biotech Regulatory Authority (NBRA), as unified regulatory, suggested Timelines set for regulatory approvals DBT to play major role in biotech regulation The report of the Task Force on Recombinant Pharma, headed by Dr R A Mashelkar, director-general, Council of Scientific and Industrial Research (CSIR), has been submitted to the Ministry of Environment and Forests (MoEF) for action. The Genetic Engineering Approval Committee (GEAC) under MoEF had been acting as the key biotech regulator, providing environmental clearance to all products using genetically modified organisms (GMOs). " My report will ensure that 90 percent of the organisms used by biotech companies which are from Category I and II will be out of the purview of GEAC," Dr Mashelkar told BioSpectrum immediately after submitting the report. Officials at MoEF expect most of its recommendations to be implemented in the coming months. However, a ministry official cautioned that the industry should not jump to start implementing its suggestions and await the relevant notifications to be issued by relevant government agencies. Officials expect these processes to be done in the next three months and the industry could start getting the benefits of Mashelkar's recommendations from January 2006. The Task Force was appointed by MoEF In March 2004 to suggest a new regulatory framework for recombinant pharma products. This followed a series of representations to the government from the industry to streamline the regulatory system for biotech products. BioSpectrum presents here the highlights of the recommendations of the Mashelkar Task Force: Analyzing the various issues and relevant suggestions made by biotech stakeholders regarding the streamlining of the current regulatory framework and procedures outlined in the DBT guidelines for implementation of Rules 1989 of EPA, the Task Force came to the conclusion that (i) There is no overlapping of regulatory objectives up to the evaluation of pre-clinical study data generated by the applicant on the recombinant pharmaceutical products (ii) The regulatory process can be expedited if the regulatory objectives of GEAC and DCGI are clearly defined. The Task Force recommends that the regulatory objective of GEAC should be confined to regulation of proposals which involve the large scale use of LMOs from environmental angle. Evaluation of the product safely, efficacy, clinical trials and market authorization is the mandate of the DCGI (iii) The current regulatory procedure under 'Rules 1989' of EPA is applicable to all recombinant pharma products irrespective of the risk group of LMOs. Therefore, the current regulatory procedure and protocols for product development, clinical trials and market authorization should be elaborated to address various scenarios in the development and marketing of recombinant pharma products. The specific recommendations of the Task Force are stated below: Recommended Procedure for Regulation of Recombinant Pharma Products derived from Living Modified Organisms (LMOs) Taking into consideration the regulatory objective of GEAC, which, is confined to regulation of LMOs, two protocols are recommended: (i) products derived from LMOs but the end product is not a LMO and (ii) product derived from LMO where the end product is a LMO. The product where the end product is a LMO has the potential for propagating/replicating in the environment and therefore needs a higher level of regulation as compared to products derived from LMOs where the end product is not a LMO. Further the magnitude and probability of environmental risk depends on the extent of use of LMOs within the R&D and production units. In case of imports this risk is not there, especially in cases of therapeutic proteins in finished form. Taking into consideration various aspects, the Task Force recommends that the regulatory procedure needs to be rationalized for the following five scenarios: a) Indigenous product development, manufacture and marketing of pharmaceutical products derived from LMOs but the end product is not a LMO b) Indigenous product development, manufacture and marketing of pharma products where the end product is a LMO c) Import and marketing of LMOs as drugs/pharmaceuticals in finished formulations d) Import and marketing of LMOs as drugs/pharmaceuticals in bulk for making finished formulation e) Import and marketing of products derived form LMOs as drugs/pharmaceuticals in bulk and/or finished formulations where the end product is not a LMO The Task Force has detailed the procedures for each of these five scenarios. The detailed procedures will be available on the BioSpectrum website (www.biospectrumindia.com) Common Recommendations applicable to all five scenarios 1. Approval for import of recombinant organisms for the purpose of research and development is within the purview of RCGM 2. The regulatory agency to authorize human clinical trials would be the DCGI in all cases. However, approval of GEAC is necessary prior to conduct of Phase III clinical trials where applicable as outlined in Protocol II, III and IV. 3. In situations where approval of both DCGI & GEAC is mandatory, clearances from these regulatory agencies need be interlinked and both agencies can process their case concurrently. Functions of the Regulatory Commitees/Competent Authorities under Rules 1989 of EPA and Drugs & Cosmetics Act, 1940 and Rules 1945. a. IBSC ( Institutional Bio Safety Committee) to examine proposals involving r-DNA work; to ensure adherence of Recombinant DNA Safety Guidelines of 1990 including preparation of emergency plans; examine product protocols for pre-clinical studies and inspection of containment facilities at R&D and production units. Throughout the product development, pre-clinical and clinical trials and manufacturing, the IBSC would act as a nodal point for interaction with statutory bodies. As per the Recombinant DNA Safety Guidelines of 1990, IBSC can approve experiments utilizing organisms and genetic elements from Risk Group-I and II under intimation to RCGM. This practice would continue. For experimental use of organisms falling in Risk Group III and above, IBSC would make its recommendations to RCGM. IBSC would also examine the protocols for toxicity/allergenicity studies as per national and international guidelines and make their recommendations to RCGM. IBSC to recommend to RCGM import/exchange of GMOs/LMOs, vectors, gene constructs, plasmids etc., for research purposes. b. RCGM to approve experiments utilizing the organisms and genetic elements of all Risk Group organisms. This is as per the Recombinant DNA Safety Guidelines of 1990. RCGM to approve protocols for preclinical studies for all products. RCGM to submit its recommendations on the preclinical studies/data directly to the DCGI. For the products from the Risk Group III and above organisms, RCGM to examine the information on containment facilities at the R&D and production sites as well as the results of the preclinical studies and submit their recommendations both to the GEAC and DCGI. Approvals for import of recombinant organisms for the purpose of research is the mandate of RCGM. c. GEAC to confine its regulatory role in terms of product approval if the proposals involve use of LMOs falling in Risk Group III and above as well as use of LMOs in open environment specifically when the end products are LMOs per se. In this context GEAC to approve activities involving large scale use of LMOs in industrial production and application; authorize large-scale production and release of LMOs into the environment; adopt procedures restricting or prohibiting production, sale, import and use of LMOs for applications under EPA; authorize agencies or persons to have powers to initiate punitive actions under EPA against defaulters. d. DCGI to examine preclinical studies data on animal toxicity and allergenicity and Quality Control data and the protocol for human clinical trial and approve production of trial batches. Prior to market authorization, DCGI to examine human clinical trial report, test reports from a laboratory designated by DCGI. The responsibility of post market surveillance is the mandate of DCGI. For products and processes involving Risk Group III and above organisms, DCGI will make available its decision on Phase III clinical trials to the GEAC. The Timelines of decisions: A consensus on the following timelines emerged for various approvals by the regulatory committees/competent authorities. RCGM approval for preclinical animal studies : 45 days RDAC approval for Human clinical trials protocol : 45 days RDAC ( DCGI) examination of clinical trial Data and response : 90 days Simultaneous DCGI & GEAC decisions : 45 days Documentations to be submitted by the applicant to the regulatory authorities for obtaining clearances. The Task Force observed that formats for preparing documents to be submitted by the applicant to the IBSC, RCGM and GEAC have been evolved and is adequate for taking a view on the proposals. The proforma forms have been attached as annexures X, XI and XII. The Task Force recommends that a format for submission of data to the DCGI by the applicant be evolved by the DCGI at the earliest. Recommendations on other Linked Issues: 1. The definition of LMOs will include only those organisms modified by r-DNA techniques through human interventions. MoEF in this regard would issue necessary amendments to Rules1989 of EPA. 2. Since the responsibility of according market authorization for recombinant drugs is being entrusted to DCGI, there is an urgent need for strengthening the Committees under the Drugs & Cosmetics Act and Rules. 3. The expertise in the various regulatory agencies under Rules 1989 of EPA should be further strengthened. 4. There is a need for creation of an independent inspection facility to audit the manufacturing and containment facilities set up by the applicants involved in the production of recombinant drugs. This would also ensure acceptability of the Indian r-DNA pharmaceutical products in the global market. Since there is no single agency with adequate field level support system to carry out an independent inspection, the Task Force recommends that the Government may set up a separate agency for this purpose. 5. The products emanating from mono-clonals derived from rDNA technology in the form of therapeutic proteins/drugs would attract the provisions of Rule 1989 of EPA, and can be treated under Protocol I as Risk Category I & II. 6. Enzymes /industrial products from GMOs would attract the provisions of Rule 1989 of EPA. In such cases, RCGM may be authorized to approve such proposals under intimation to GEAC. 7. If there is a change in the host organism or expression construct, fresh permission will be required to be sought from RCGM for the change by providing adequate data on bio-equivalence. If the data is found to be inadequate then RCGM may prescribe limited pre-clinical and/or clinical studies to be conducted to establish bio-equivalence. This would also be applicable to finished imported products intended for marketing. 8. No imported recombinant pharma product should be allowed to be introduced in the Indian market without adequate evaluation of clinical trial data or clinical evaluation in the country. The Task Force recommends that the efficacy and safety of the imported product should be evaluated for its efficacy on the Indian population before issue of market authorization. 9. For import of GMO / LMO for research/contract manufacturing or similar service, where the product (which is not an LMO) is to be exported out of India, a procedure should be laid down so that the companies can explore opportunities for this business while the safety aspect is also adequately addressed. A suggested procedure is: IBSC to examine proposal and recommend to RCGM; RCGM to approve if within Risk Group I and II. If organism is of Risk Group III or above, GEAC permission will be required. DCG(I) need not play any role. 10. On the issue of seeking approvals of PPA/DCGI/GEAC under Rules 1989 of EPA and PQO by Customs Authorities on the imports of microorganisms, GMOs/ LMOs for R&D purpose it is suggested that the earlier practice of permitting the import with the approval of RCGM should continue and PPA/DCGI to issue instructions to Custom Authorities to clear the consignment based on RCGM approval. 11. Regarding the constraints faced by the industry for import of non-GMOs, PPA may issue instruction to Customs Authorities to clear the consignment based on the declaration of the importer/exporter on certification of the nature of the non- GM organisms etc. Standing Technical Advisory Committee on Biotechnology Regulation 1. Since several modifications have been made in the existing regulatory mechanism for recombinant pharma; during its implementation, several anomalies may become apparent. To address these issues, the Task Force recommends, constitution of a Standing Technical Advisory Committee on Biotechnology Regulation to redress and look into various regulatory aspects and make issue based recommendations on case-by-case basis. Prior to any deviation from the proposed regulatory mechanism, which when comes in vogue, the views of this Committee should be obtained in the first instance. 2. The terms of reference of the proposed Standing Technical Advisory Committee should be to address the issues emanating from the overlapping/ conflicting Rules in various Acts applicable that are regulating biotechnology activities at R&D, import, export, trials, release, etc. and also to frame guidelines from time to time to facilitate the growth of biotechnology in the country. Since the issues involved are highly technical and complex, the Task Force recommends that the Standing Technical Advisory Committee should comprise of an expert body instead of an inter-ministerial body. An eminent Scientist should head the Standing Technical Advisory Committee and the members should include Chairman Genetic Engineering Approval Committee (GEAC), Chairman RCGM, Member-Secretary GEAC, Member-Secretary RCGM, DCGI and Experts on Immunobiologicals, Biogenerics, Plant Breeding, Molecular Biology, Environmental Sciences and other relevant areas. 3. The Committee can be administratively supported by any of the concerned agencies. Proposed Independent Institutional Mechanism National Biotechnology Regulatory Authority/Commission 1. The group believes that the creation of a professionally managed single authority would send a strong signal to the international community and promote trade and investment as well as ensure timely and effective regulation. While it is desirable to establish an independent professionally competent authority, if possible, for providing single window approvals, the Group also recognized the fact unless the existing relevant statutory requirements under EPA/Seeds Act/ DCGI are harmonized; setting up a NBRA may lead to "one more window clearance instead of a single window clearance". It is therefore recommended that such harmonization is an essential prerequisite for establishing the national biotechnology regulatory authority. 2. On the issue of the model for NBRA, the Group recommends that one of the models for National Biotechnology Regulatory Authority/Commission (NBRA), similar to the FDA system was proposed by Secretary DBT in the second meeting of the Task Force held on 15 June, 2004 may be considered by the Government. The proposed model recommends that the NBRA would comprise of four wings namely: a) Agricultural products / Transgenic Crops b) Pharmaceutical/ Drugs and Industrial Products c) Transgenic Foods/Feed and d) Transgenic Animals/ aquaculture. Professionals who have been well trained in regulatory affairs would manage the four wings of the authority. This will facilitate more interactive regulatory process. A Vice Chairman would head the four wings of the Secretariat. The recommendation of the Secretariat would be forwarded to Apex Committee with Statutory Powers. The members of the Apex Committee would comprise of representatives from all stakeholders Ministries/ Departments. The Apex Committee would report to the Chairman. The proposed model for NBRA is given at Annexure- XII. 3. Alternate models of how a National Biotechnology Regulatory Authority can be created also need to be examined. 4. In view of the complexities, the Task Force recommends that an inter-ministerial group be established to examine the model proposed by Secretary DBT among various others administrative Departments/ Ministries, for functioning of the proposed authority and make specific proposals with respect to the implementation including the budgetary requirements. Click here to download Mashelakr-Taskforce pdf file ]]> <![CDATA[The October Wish List to Kapil Sibal]]> https://biospectrumindia.com/news/95/2255/the-october-wish-list-to-kapil-sibal.html https://biospectrumindia.com/news/95/2255/the-october-wish-list-to-kapil-sibal.html Tue, 11 Oct 2005 14:48:00 +0530 The October Wish List to Kapil Sibal The October Wish List to Kapil Sibal At the first "Biotech CEO Summit" organized by BioSpectrum at Hyderabad on September 23, 2005, Kapil Sibal, minister of state for science and technology and ocean development, who was the chief guest had asked the diagnostic companies to provide a list of important reagents and raw materials which needs import duty exemption so as to take up the issue with the relevant government agencies. The wish list from the diagnostic industry There exists a serious anomaly with respect to imported and indigenous diagnostics wherein raw materials and components used by indigenous manufacturers for such products are levied customs import duty and excise duty whereas the finished products are allowed to be imported duty free. This is detrimental to indigenous manufacturing and instead encourages trading. Furthermore, it puts indigenous manufacturers at an unfair disadvantage to multinational competition. The components and raw materials used by indigenous manufacturers for the production of diagnostics needs to be exempted from Custom Import duty. Customs duty is charged on raw materials, where as the finished product is duty exempted: They are AIDS/HIV Testing kits (General Exemption No.107, S.No.83, List 4, No.32) and Hepatitis. In this case, the finished products (HIV/AIDS Kits) are exempt from customs duty, but the raw materials required are not exempted. Importers have to pay a hefty duty of more than 40 percent (3822.00.12). After paying hefty customs duty of over 40 percent on raw materials, how can Indian products be cost effective? Hence countries like China, Korea and Taiwan are dumping their products on Indian soil at below cost price. Therefore, the industry requests the authorities to exempt the raw materials required to manufacture all duty-exempted products (List 4 of S.No.83, Exemption No.107). Two types of duties are levied for the same product: In General Exemption No.107, List 4 for S. No. 31, 32 for Hepatitis B antigen and HIV the customs duty is exempted and for the same in List 37 they are taxed at 5 percent. Some listings for exempted products are outdated: In General Exemption No. 107, No.95 in the table, raw materials for making the ELISA kits are taxed at 5 percent. The list is outdated. Again the finished kits are nil duty (List 4, S.No. 36) and raw materials are taxed at 5 percent. All reagents/ raw materials like Coagulation reagents (38.22.0090), Hematology reagents (38.22.0090), used for manufacturing all types of test kits -Biochemistry Tests, Haematology Tests and Immunology tests (such as HIV, HBsAg, Hepatitis etc) should be given customs duty exemption from the current total custom duty of 34.44 percent (inclusive of basic duty + CVD + 2 percent cess) (General Exemption No.107, List 4, Sr No.36, Sr.No.83 of the table of customs notification No 21/2002). Similarly the industry requests the government to exempt customs duty on all types of Quality Control and Calibration Materials required in Clinical Test Labs (38.02.1091) from the present custom duty of 17.3 percent (CVD not applicable). In addition to that even the ELISA analyzers (General Exemption No.107, List 37, Sr No.66, S.No.363 of the table of customs notification No 21/2002), ELISA Plate Washers, Haematology Analyzers, Coagulation Analyzers, used for testing of HIV, Hepatitis etc. should get the custom duty exemption. Many companies from China, Korea and Taiwan, are dumping the diagnostic kits at below the material cost. For example, Pregnancy test, HBsAg test, HIV rapid and ELISA test. This affects the domestic manufacturers and loss of revenue to the government and loss of employment generation (Indian jobs). Therefore, the government is requested to consider imposing dumping duty on the products, which are imported below the material cost. The government has to strictly implement the anti dumping policy in case of health care sector and especially for diagnostics sector. With no proper policy framework in place, the local diagnostic industry has to change its marketing strategy every now and then and it is detrimental for the growth of this upcoming industry. Every one talks about abolishing the requirement of licensing and say â€“ "License raj has gone"! This may be true in many cases, but in healthcare and diagnostics, it is still in place. Now one has to get license or NOC, even to import small quantities of raw materials for both manufacturing and R&D. For each and every item, if companies have to go to Delhi and get license, most of their time and resources are lost and in addition, precious time is also lost. Therefore, abolish the requirement of licensing/NOC to import the raw materials. Only the Metro Airports are authorized to import the Diagnostic reagents as per the recent circular from Drugs Controller of India, which again makes it really difficult to the small manufacturing units. Please allow the industry to import the raw materials through major airports like Bangalore. In the last budget, without any discussion, the finance ministry has changed the turnover limit for SSI Exemption. Now, if any SSI unit crosses the turnover of Rs 4 crore in the preceding year, that SSI unit will lose the SSI benefit and has to pay the duty from day one. The Rs 4 crore turnover includes all transactions, whether dutiable or not, including trading items. Before, it used to be only the dutiable items. In today's market with very low margin, Rs 4 crore turnover is too low. Then again if we have to pay 16 percent Excise duty, then most of the SSI units will become non-profitable. This also forces the SSI units to limit the sales to below Rs.4 crore. This is penalizing the SSI units, which want to do well. Please change the provision on Excise duty â€“ Turn Over Limit to the earlier version. Anyway, once SSIs cross the Rs 1-crore limit, they will pay the duty for the dutiable items, and the government will not lose revenue. The indigenous diagnostic kits are levied 16 percent Excise Duty whereas imported kits are exempt of all duties. Diagnostic kits are vital for HIV AIDS, infectious diseases and other critical care applications. The positive impact of such an Excise Duty waiver will far exceed the small impact it will have on the exchequer. Moreover, it will put the indigenous diagnostic industry on a level playing field with global competition. The government should support the exporters to overcome the competition in overseas markets from multinationals in terms of quality and price. Since we still don't have a single window clearance system in place, we are losing the orders due to time bounding conditions put by the buyer in the agreement. The government has to address this issue too. The government should consider giving a generic exemption for each test rather than individual items. Items may change from time to time and then again the companies we have to get the approval, which is very difficult. And we may have to face many hurdles/problems from the customs and drugs control authorities at the ports. Rather than listing the individual raw materials for exemption â€“ say, "raw material required to make HIV kits â€“ List may be approved by the DCI. The government should set up a working group to sort out the discrepancies and which should also advice the authorities on these issues. Drug authorities should be trained to tackle the problems arising in this industry. List of reagents & raw materials The items that need customs duty exemption include recombinant or peptide or native antigens for the development and manufacture of immunoassays such as: Tuberculosis, Toxoplasmosis, Cysticerosis, Rubella, CMV, Herpes Simplex virus, Leptospirosis and Human papilloma virus (HPV). Recombinant antigens 1. HIV-1 antigen 2. HIV-2 antigen 3. HIV-O antigen 4. Protein A 5. HIV-1 gold conjugate 6. HIV-2 gold conjugate 7. HIV-O gold conjugate 8. Protein G gold conjugate 9. Malaria antigen gold conjugate 10. HCV antigen gold conjugate 11. Protein A gold conjugate 12. Malaria Pf antigen 13. Malaria Pv antigen 14. HCV antigens Enzymes 1. Glucose Oxidase 2. Peroxidase 3. Hexokinase 4. Glucose 6 phosphate dehydrogenase 5. Cholesterol oxidase 6. Cholesterol Esterase 7. Glutamate Dehydrogenase 8. Urease 9. Uricase 10. Lactate Dehydrogenease 11. Malate dehydrogenease 12. Lipoprotein Lipase 13. Glycerol Kinase 14. GPO 15. Protein A- HRP Biochemicals 1. Aspartic acid 2. Alanine 3. Bovine serum albumin 4. NADH 5. ATP 6. ADP-k 7. PNPP 8. Cholic acid 9. Creatnie Phosphate 10. Amino Antipyrine 11. DHBS 12. Ketoglutarate 13. LDH 14. MDH 15. Control Seras 16. TMB substrate 17. Anti-HBsAg angi 18. Anti-HBsAg-HRP Antibodies 1. Monoclonal antibodies 2. Polyclonal antibodies 3. Mouse IgG 4. Goat anti-mouse IgG 5. BSA 6. Malaria antibody gold conjugate 7. Anti-malaria (Pf) 8. Anti-malaria (Pv) 9. Anti-HBsAg gold conjugate Buffers 1. Pipes 2. Hepes 3. Tris 4. Glycylglycine 5. Mes Detergents 1. Tritron-x-100 2. Brij 35 3. Polyethylene Glycol 6000 4. Trehalose 5. Gold conjugate release pad 6. Whole blood filter pad 7. 0.45u flow through filter membrane 8. Triton-X detergent 9. HRO- stabilizers 10. Nitrocellulose membrane 11. Latex reagents 12. Microtiter ELISA wells (plate) ]]> <![CDATA[PM presents Bhatnagar prizes]]> https://biospectrumindia.com/news/95/5610/pm-presents-bhatnagar-prizes.html https://biospectrumindia.com/news/95/5610/pm-presents-bhatnagar-prizes.html Tue, 11 Oct 2005 14:47:00 +0530 PM presents Bhatnagar prizes PM presents Bhatnagar prizes Prime Minister Dr Manmohan Singh presented the prestigious Shanti Swarup Bhatnagar Prize to 21 young scientists for their achievements in science and technology in 2004 and 2005 on September 28, 2005 in New Delhi. With this, the number of Bhatnagar laureates so far has gone to 419. Congratulating the winners, Dr Singh said they were the real creators of new India. He thanked the young scientists for their role in nation building. "This award confers on you the responsibility to continue to engage yourself in pursuit of good science," he said, adding that "India must assume the role of leadership among the developing countries through their innovations in science and technology." While Dr Gopal Chandra Kundu of the National Centre for Cell Science, Pune and Dr Ramesh Venkata Sonti of the Centre for Cellular and Molecular Biology, Hyderabad received the award in the biological sciences category, Dr Chetan Eknath Chitnis of the International Centre for Genetic Engineering and Biotechnology, New Delhi received the award in medical science cateogory. Dr Singh also presented S S Bhatnagar Prize for 2005 to Dr Tapas Kumar Kundu of the Jawaharlal Nehru Centre for Advanced Scientific Research, Bangalore and Dr Shekhar Chintamani Mande of the Centre for DNA Fingerprinting and Diagnostics, Hyderabad (biological sciences) and Dr Javed Naim Agrewala of the Institute of Microbial Technology, Chandigarh (medical sciences). Kapil Sibal, minister of state for science and technology and ocean development and Dr RA Mashelkar, director general, CSIR were also present. They basked in the limelight... Dr Tapas Kumar Kundu Dr Tapas Kumar Kundu is an assistant professor at the Transcription and Disease Laboratory of the Molecular Biology and Genetic unit at the Jawaharlal Nehru Centre for Advanced Scientific Research (JNCASR) in Bangalore. Dr Kundu's research areas include regulation of eukaryotic (human) transcription from chromatin template with special emphasis on diseases. He has contributed articles for several science publications. Dr Shekar C Mande Dr Shekar C Mande heads the Laboratory of Structural Biology at the Centre for DNA Fingerprinting and Diagnostics, Hyderabad. He did his MSc in Physics from Nagpur University, Nagpur and his PhD from the IISc, Bangalore. Speaking to BioSpectrum, he said, "My work revolves around understanding structure- funtion properties of M. tuberculosis proteins, and trying to correlate their significance to the clinical manifestations of the disease. In a recent work, we determined the structure of the M. tuberculosis Chaperonin-10, and proposed that it chelates calcium ions. The protein is unexpectedly known to be secreted, and therefore chelation of ions might explain its role is bone degradation, through Ca2+ mediated signalling pathways. In another work, we have determined the structure of Chaperonin-60, and proposed that it functions in such a manner that utilisation of ATP is minimized. This may have a relevance in the survival of M. tuberculosis in its latent phase." Dr Gopal Chandra Kundu Dr Gopal Chandra Kundu is a cancer biologist at the National Centre for Cell Science, Pune. He has been awarded the Shanti Swarup Bhatnagar Prize, 2004 for his outstanding contributions towards the understanding of the molecular mechanism of the regulation of metastatic potential of melanoma (skin cancer) and breast cancers through activation of transcription factor mediated gene expression by a chemokine like extracellular matrix protein, osteopontin (OPN). His findings highlight the oncogenic potential of OPN and this will be useful in developing novel molecular diagnostics and targeted therapy for the treatment of cancer. Dr Kundu has received several other awards including National Bioscience Award, 2003-04, by the Department of Biotechnology. He has published about 36 papers in peer reviewed, high impact factor international journals including Science, Nature Medicine from USA and a series of papers in The Journal of Biological Chemistry from NCCS, Pune and obtained one US patent. Dr Ramesh V Sonti Dr Ramesh V Sonti is currently working at the Centre for Cellular & Molecular Biology, Hyderabad. He has done his doctoral work at the University of Utah, Salt Lake City in the US and post-doctoral work at Massachusetts Institute of Technology (MIT), Cambridge, USA. Dr Sonti bagged the SS Bhatnagar Prize 2004 for his research on understanding virulence mechanisms for the important bacterial leaf blight pathogen of rice. His research has also focused on introduction of bacterial leaf blight resistance characteristics into the background of commercially important but disease susceptible rice varieties. Dr Chetan Eknath Chitnis Dr Chetan Eknath Chitnis is an assistant scientist/principal investigator at the ICGEB, New Delhi. His research interests include understanding molecular interactions that mediate pathogenic processes such as red cell invasion and cytoadherence by malaria parasites. His laboratory also studies host immune responses that provide protection against malaria to residents of malaria endemic regions. Information from these basic studies on host-parasite interactions and immune responses is used to develop vaccines that will provide protection against P. falciparum and P. vivax malaria. Dr Chitnis has many other awards to his credit including the MOT Iyengar Award for Research on Malaria (Indian Council of Medical Research) 2000. ]]> <![CDATA[FICCI picks 8 areas for BT tie-ups with China]]> https://biospectrumindia.com/news/95/1894/ficci-picks-8-areas-for-bt-tie-ups-with-china.html https://biospectrumindia.com/news/95/1894/ficci-picks-8-areas-for-bt-tie-ups-with-china.html Tue, 11 Oct 2005 14:45:00 +0530 FICCI picks 8 areas for BT tie FICCI picks 8 areas for BT tie-ups with China The FICCI Biotech delegation in China. Collaborative R&D, speeding up of pre-clinical study, bioinformatics/chemi-informatics, free flow of biological materials, preferential incentives, exchange and technology transfer and human resource development are the major areas where Chinese and Indian biotech companies could collaborate for mutual benefit. These potential areas of tie-up between Indian and Chinese biotech companies have been identified by a 13-member FICCI biotech mission to Beijing, Shanghai, Tianjin and Nanchang, led by Dr Krishna M Ella, chairman, FICCI National Biotechnology Committee, and CMD, Bharat Biotech International Ltd. Collaborative R& D Chinese companies can outsource new drug discovery to India, whereas further drug development and pre-clinical studies can take place in China and India simultaneously. This would enable both countries to come together to become global suppliers of Innovation Based Drugs (India's costs are 1/8th and China's 1/5th compared with the cost incurred by the US.) China can help India in vaccine development, gene therapy and stem cell research as they are much ahead. Faster pace of pre-clinical study In-vivo studies at the preliminary level would be faster in China as there are no ethical or long procedural issues for animal experimentation in that country. Also, the animals for experiments can be obtained from China's national resource centers such as the one at Nanching University. Bioinformatics/chemi-informatics Data management expertise of India can be well utilized by Chinese biotech and pharmaceuticals players in order to get their labs GMP and GLP complaint. Free flow of biological materials There can be a free flow movement of biological materials, which include microorganisms and animals such as different strains of mice between two countries. If drugs are developed as a collaborated effort between India and China, these can be exported together to highly regulated markets such as the US, the UK and Australia. India can help export Chinese biotech products to these markets and China can help India export drugs/vaccines to China by collaborating at a research level for speedy approval from SFDA. Benefit of preferential incentives Indian companies can take benefit of preferential incentives offered by SEZs to set up representative offices at some of the provinces such as Nanjing and Tianjin so that SFDA approval can be easily obtained. Exchange and technology transfer There is scope for exchange and technology transfer of off-patented technologies to India, which have yet not been commercialized in China, and this may have a huge scope in the Indian market. Human resource development Education in field of life sciences, biotechnology and clinical research (exchange program of scientists) in creating a total skill set has been identified as a potential area for collaboration. This is because India is good at GLP/GMP and data management whereas China has expertise in technology development and commercialization. ABLE opens regional chapters The Association of Biotechnology Led Enterprises (ABLE), a collective face and voice of the Indian Biotechnology industry has decided to open its regional chapters in Hyderabad (South), Mumbai (West) and New Delhi (North) to establish a direct interaction with companies based in these cities. Dr M Vidyasagar, executive vice president and head of advanced technology centre, Tata Consultancy Services will head the Hyderabad Chapter as hon. regional director. Dr Vidyasagar said, "I am delighted to see that ABLE is making a concerted effort to spread its wings beyond Bangalore, where its head office is currently located. With so many biotech companies in Hyderabad, I am sure we will be able to create a vibrant chapter here." Alok Gupta, country head - life sciences & technology, YES BANK will head the Mumbai Chapter as hon. regional director. Gupta said, "ABLE is an excellent forum representing India's Biotech environment. In my role as regional director, I hope to showcase Mumbai's inherent strengths in life sciences and biotechnology, and further develop as a robust platform to aid development of the biotechnology industry in India." Rajesh Jain, joint managing director, Panacea Biotec Ltd will head ABLE's New Delhi Chapter, as hon. regional director. Commenting on his plans for the New Delhi Chapter, Jain said "The Delhi Chapter will strive to further enhance ABLE's vision by offering a platform for establishing tripartite relationship between the industry, the government and academia specially for north India - the three important pillars for developing an economically successful and socially responsible biotech industry in India. The chapter would undertake proactive role in organizing regional, national and international seminars/symposium/workshops/group discussions to address critical issues relating to the growth of biotechnology." Matrix signs pact to acquire controlling stake in Mchem Group, China Matrix Laboratories has announced that the company has entered into a Share Purchase Agreement (SPA) with the promoters of Mchem group, China for the acquisition of controlling stake of about 60 percent in the Mchem group. The closing of the transaction is expected to be completed by the end of December 2005 and is subject to fulfilment of certain conditions/formalities and obtaining requisite approvals from the regulatory authorities. The share purchase agreement is in line with the strategic intent and the memorandum of understanding that the company had signed earlier with Mchem to gain access to the comparative advantage that China provides in the sourcing of pharmaceutical chemicals and intermediates, and to establish a cost effective supply chain. The acquisition of substantial stake in Mchem group will help the company to backward integrate into China for manufacture of intermediates and will help consolidate its position as a major supplier of Active Pharmaceutical Ingredients (APIs), particularly Anti-retrovirals (ARVs), worldwide. GangaGen signs pact with Elanco Animal Health Gangagen Life Sciences (GLSI) has announced the signing of a collaborative research, license and commercialization agreement with Elanco Animal Health to develop anti-bacterial products derived from bacteriophages. Under the terms of the agreement, GLSI and Elanco intend to jointly develop and commercialize phage-based products for the control of dangerous bacteria that pose problems for human and animal health. Financial terms were not disclosed. "This agreement is of great importance to GLSI, and to the health market in general," said Rainer Engelhardt, chief executive officer of GLSI. "The fact that a global leader such as Elanco has chosen to work with GLSI in the development and marketing of phage-based products as antibacterial treatments is a tremendous validation of our vision and progress, and of phage technology itself." ISO recommendation for HCL to manufacture medical electronic products HCL, a leading global IT enterprise, has been recommended by TUV Germany for the ISO 13485:2003 certification for the manufacture of medical and electronic products. HCL is the first IT enterprise in India to have been recommended for this certification for manufacturing medical electronic devices that endorses compliance with international standards. Commenting on this recommendation, Pradep Nair, vice president and head, life sciences practice, HCL, New Jersey, US said "An early adoption of the standard will give us an edge in the market. The certification assures our clients of HCL's ability to manage the right process and helps them achieve quantum improvements in all aspects of the life science project lifecycle." BII introduces PG Diploma in Pharma Regulatory Affairs Bioinformatics Institute of India has recently introduced an innovative program in Pharma Regulatory Affairs. The course, PG Diploma in Pharma Regulatory Affairs, has been developed to educate professionals about the regulatory issues pertinent to the pharmaceutical and biological industry .The objective is to impart in-depth and latest knowledge required for a successful career in regulatory affairs. According to Vijay Shukla, director, Bioinformatics Institute of India, "This is a highly specialized and well designed course which promises wonderful career options in the upcoming pharmaceutical industry in India. Pharma Regulatory Affairs professionals also has a very good demand, all over the world." The program has six modules comprises of Pharma Regulation Practices and Procedure, Pharma Patents, IPR and Regulation, Pharma Regulatory Regime in USA, EU and India, Clinical Trials & Regulation, Good Manufacturing Practices, Quality Assurance and Regulation, Regulatory Compliance for Pharma and Biotech Products. ClinInvent implements Oracle Clinical to drive project efficiencies ClinInvent Research has implemented Oracle Clinical software for faster and more accurate data management. This will help ClinInvent to achieve greater efficiencies and reduce costs of clinical trials. "The implementation of Oracle Clinical is a strategic initiative on our part to leverage our data management team's IT capabilities and to offer our international sponsors high quality data management." said Dr Arun Bhatt, president, ClinInvent Research. "We decided on Oracle over other competing solutions as Oracle software is not only adopted universally, it is also 21 CFR Part 11 compliant, globally recognized and well supported by easy access to training," he added. Indian students participate in UN Convention on Biodiversity Indian students participated in the negotiations of Model United Nations Convention on Biodiversity held from August 18-20,2005 at Giessen, Germany. As a part of the program "Biotechnology: law and policies in Europe" at Justus Liebig University, Giessen conducted by Hessen International Summer University (Hessen Ministry of Higher Education ) DAAD ( German Academic Exchange Service), the students discussed issues like access to plant genetic resources and protection of traditional knowledge at international level.There were about 25 participants from 17 countries including three participants from India - Priyank Gupta, Pushpendra Jaiswal and Pratyush Chandan. All of them are doing their B Tech, Biotechnology from Jaypee Institute of Information Technology, Noida, UP. As a part of the program the students also attended a seminar on biotechnology policy issues at European Union's parliament in Brussels, Belgium. ]]> <![CDATA[Raising The Biotech Bar]]> https://biospectrumindia.com/news/95/1469/raising-the-biotech-bar.html https://biospectrumindia.com/news/95/1469/raising-the-biotech-bar.html Tue, 11 Oct 2005 14:34:00 +0530 Raising The Biotech Bar Raising The Biotech Bar A year ago, S&T Minister Kapil Sibal, set a difficult target of $5 billion biotech revenues by 2010. And BioSpectrum took the lead to organize a meeting of the industry leaders in Hyderabad on September 23,2005 to discuss the strategies to make this happen. Sibal came personally once again to address the biotech CEOs. This time around, he has raised the bar even more. His reasoning: If most of the 200 plus biotech companies do as well as the Top 20 ones, from a base of $1 billion, $5 billion target shouldn't be a sweat for the doers of the industry. Of course, it was not bravado. The minister had come prepared with the score sheet on his promises made to the industry exactly a year ago. His mark sheet would have made anyone proud as he had delivered on most of the promises. This time, he asserted the government's readiness to go to any lengths to help the biotech which he sees as a big player in the global arena, if we get all the basics rights. "The government will fund the industry. It is not an obligation. It is the industry's right to get it to take the country forward," was one of Sibal's strong message. The minister has publicly announced the decision to keep his doors open and wants the industry to meet him once in two months with their demands and also get an update on the actions taken by the government. Rarely does a Cabinet minister make such an offer and it is now for the biotech industry take it up immediately and get things done in their favor. BioSpectrum would certainly like to take the lead and be part of the process to get the biotech sector's grievances redressed. Taking a cue from Sibal, this issue has a detailed Wish List from the diagnostics sector on specific actions they would like from the government and list of components that require import duty exemption. We hope to highlight various such industry demands in every issue of our magazine, till they get exhausted and the industry is left with no demand. September has been another good month for the industry. The much-awaited report of the Task Force on Recombinant Pharma, chaired by Dr R A Mashelkar has been submitted to the Ministry of Environment for action. In one sweep, the report has recommended the removal of the GEAC oversight of LMOs, which are used by nearly 90 percent of the biotech industry for research and product development. GEAC would confine itself to environmental aspects genetically modified organisms and it will not share the turf with the drug controller on clinical trials, market authorization etc. The multi-agency regulatory process followed by GEAC had been a major bugbear of the biotech sector. The task force has also recommended the setting up of a unified National Biotechnology Regulatory Authority to provide a sort of singe-window regulatory mechanism. And in another significant recommendation, Mashelkar has outlined the timelines for regulatory clearances which should provide some certainty to the applicants. The minister has assured that the government was keen to implement most of the recommendations and only those which require legislative actions may take some more time. Sibal has thrown the gauntlet and also promised all help. Let the industry leaders take up the challenge wholeheartedly and make it the Indian Biotech Century. ]]> <![CDATA[Crystal gazing into future of life sciences]]> https://biospectrumindia.com/news/95/1544/crystal-gazing-into-future-of-life-sciences.html https://biospectrumindia.com/news/95/1544/crystal-gazing-into-future-of-life-sciences.html Tue, 11 Oct 2005 14:33:00 +0530 Crystal gazing into future of life sciences Crystal gazing into future of life sciences Dinesh C Sharma Dinesh C Sharma is a well-known science writer based in Delhi. He was in Venice recently for the First World Conference on Future of Science. dineshcsharma@gmail.com Hopes of personalized medicine have been raised with the decoding of human genome and progress made in genomics. Can human life be prolonged? Is biomedical genetics miracle or mirage? Is human cloning ethical? Are fears about safety of genetically modified food justified? Is freedom of biomedical research jeopardized? These are some of the questions that leading scientists, Nobel laureates, business leaders, policy makers, religious thinkers and social scientists addressed at the first World Conference on "The Future of Science" held in Venice from September 21-23, 2005. For the first time, experts from different fields shared a platform to talk about some of the most difficult issues facing scientific research today. In the recent years, hopes of personalized medicine and 'life on a chip' have been raised with the decoding of human genome and progress made in various branches of genomics. The real future of biomedical advances is unpredictable. Unless scientists believe that they know fundamental facts of life, they can only use extrapolation to gauge the extent to which science will impact public health in future. Clearly two streams of thoughts have emerged, pointed out Kenneth M Weiss, professor of biological anthropology and genetics, Penn State University. Some scientists believe that genetic research will identify all the relevant physiological pathways to disease, which will be the targets of molecular intervention. On the other hand, the less enthusiastic lot feels that new molecular discoveries are actually revealing more complexities in disease causation. "There may be as much mirage as miracle in the current drive to map complex diseases. This turns prediction into predicament. We already know the evolutionary reasons and have data to support this view," said Prof Weiss. Espousing a middle path, he pointed out that behavioral and lifestyle interventions could have greater impact on public health, in much cost-effective manner, than genetic interventions. But to do this would mean diverting investment from technical research to non-technical areas of education, prevention, and behavior modification. And this is a political choice. However, genetic diseases will need to be tackled using current research approaches and they are likely to have interventions such as gene-based therapies. "Some believe that in areas ranging from behavior, to medicine, to agriculture, DNA will make this possible. But is this real or wishful thinking by scientists' self-interest? Are utopian predictions more likely than that, like the age of sail, the age of science will fade away, yielding to more immediate imperatives?" asked Weiss. "Our biomedical future may be a race between big science that depends on supporting socioeconomic structures, and the tiny, nimbly adaptable infectious microorganisms that will be the ultimate winners in the battle of life." Dr Teruhiko Wakayama, scientist at the Laboratory for Genomic Reprogramming, Kobe Center for Developmental Biology, RIKEN Kobe, said though somatic cell cloning has been demonstrated in several mammalian species including sheep, cows, cats and mice, some problems exist. Cloned animals consistently display a variety of developmental abnormalities, such as placental anomalies, obesity and premature mortality of unknown cause, besides abnormal gene expression and retention of somatic cell features. Some of these are attributed to insufficiencies in the reprogramming of the donor nuclei. Despite all these problems, Wakayama said, success in generating cloned offspring has opened new areas of investigation and provides an insight into complex processes like genomic reprogramming, imprinting, and embryonic development. Speaking on 'prolongation of human life span', Dr Leonard Guarente, MIT Cambridge, propounded a simple idea: eat less to live longer. In lab experiments, he said, a moderate to severe restriction of food consumption has been shown to extend the lifespan of rodents by as much as 50 percent! Not only this, it can protect animals from many diseases of aging, including cancer, cardiovascular disease, and neurodegenerative disease. The session on agriculture biotechnology had some interesting presentations. Rice is the most important food for the world's population, particularly developing countries, feeding half the world. So any strategy to achieve food security has to address the question of improving rice yields without increasing land use and dependence on fertilizers and pesticides. This new strategy must rely on an understanding the biology of rice and its genome, said Xing Wang Deng, professor of plant biology at department of molecular, cellular and developmental biology, Yale University. The sequencing of entire rice genome has thrown up new possibilities. The challenge now is to comprehensively and accurately annotate the rice genome and use the information to improve crop yield and quality. It is now possible to test and verify a variety of strategies to integrate current knowledge on the genome and understand what it encodes, he added. With established synteny (order of genes occurring on chromosomes) with other cereal crops, discoveries and experience in rice can easily be transferred to other cereals, Prof Deng pointed out. Thus rice constitutes a good model for testing ways modifying traits in cereal plants of agronomic importance. The current trend of terming genetically modified crops as unsafe for human health and environment came in for severe criticism by Prof Bruce M. Chassy, University of Illinois at Urbana-Champaign. "Agricultural biotechnology is an almost tragic case study stemming from confusion about risks based on science illiteracy. On the darker side, special interests stand to gain much by opposition to biotechnology," he declared. Prof Chassy said humans have been practicing biotechnology for millennia. Most of fruits and food crops that we eat are a result of a natural process of gene transfers and evolution of species in earlier times, and of conventional breeding in recent times. New tools are only quickening this process. Gene technology has been used to produce transgenic plants resistant to insects and diseases as well as tolerant to specific herbicides. Over the past 10 years, cotton, maize, canola and soybean crops have been planted on 400 million hectares in 17 countries by 8 million farmers. The safety and productivity gains are well documented. However, he said, there is global concern among consumers about the safety of biotech crops despite stringent governmental and regulatory scrutiny. He said these concerns can be traced directly to virtually 100 percent negative media coverage -much of it fueled by vested interest groups. "Though virtually unanimous in their support of biotechnology, the scientific community has been largely absent from the public discourse. Scientific culture generally discourages scientists from participation in political and social debate." Stressing on science-based risk assessment of the food systems, Prof Chassy said, "Eating a proper diet, and avoiding over-nutrition, food borne illness and naturally occurring toxicants should be the major food consumption priorities for consumers. Consumers are, on the other hand, fearful of GMOs, pesticide residues, and chemicals added to our foods. This inversion of the risk hierarchy by consumers, the media and political leaders, leads to regulatory and research expenditures on issues that will yield little real improvement in safety and health," he concluded. The conference organized by three Italian foundations - Umberto Veronesi, Giorgio Cini and Silvio Trochetti Provera â€“ adopted Venice Charter that suggested setting up of an inter-disciplinary authority of scientists, philosophers, theologians, policy makers and social scientists to examine science-society linkages more closely. ]]> <![CDATA[Venturing into Biotechnology]]> https://biospectrumindia.com/news/95/2043/venturing-into-biotechnology.html https://biospectrumindia.com/news/95/2043/venturing-into-biotechnology.html Tue, 11 Oct 2005 14:31:00 +0530 Venturing into Biotechnology Venturing into Biotechnology Vishnu Varshney CEO, Gujarat Venture Financials Ltd (GVFL). Biotech firms should more firmly establish themselves in factors relating to patents, management, innovative ideas, and commercial potential. India today is an established IT player globally. From mere body shopping, the industry has moved up the value chain to provide high-end services like consultancy. The markets are well defined and so are the regulatory policies. This has made the investors look for the next big thing. And it is Biotechnology that is being looked upon by the experts that will take India to a next level. The Indian biotech story began with Biocon way back in 1978 but has today grown to over 280 companies with six of them generating revenues of over Rs 100 crore. From its origins in fermentation and enzyme production, the $1-billion plus Indian biotech industry consists of new drug discovery, bioinformatics, clinical research, and synthetic chemistry with approximately 230 drugs in the market spanning 13 therapeutic segments. With the new product patent regime in place and a national biotech policy set to be notified soon, the Indian biotech industry is targeting $5 billion in revenues by 2010. The boom is going to be led by new age entrepreneurs who believe in innovative technology and newer avenues. Biotech will exceed the penetration of IT into everyday life in another ten years, but until then the growth of this sector will be less rapid than what was experienced by the IT sector in its peak. The global industry raised $21.1 billion in 2004, a 15 percent increase over resources raised in 2003. In comparison, Indian VCs are still cautious in committing resources for the biotech sector. Annual investment in 2004 is estimated at $150 million, an increase of just 9 percent over $137 million invested in 2003. What is worth noting here is that investments coming in this sector from the VCs are skewed towards late stage private equity deals. The products, technology and markets are clearly identified. Only about 15 percent of funding for biotech is being invested in seed stage companies, which is the need of the hour. And to my understanding, VCs investing in such start-ups are few and sparse. The potential of biotechnology as an emerging sector can only be fully realized if the venture capital funds come forward proactively. The main reason that most VCs are hesitant in investing funds at early stage to the biotechnology industry is mainly because of exit issues from a small size company, uncertain business models and financials and uncertain regulatory systems. With the biotechnology segment gaining prominence and with its capability to act as a strong vehicle to transform the socio-economic deficiencies, the venture capital funds should develop a sense of confidence to invest more into the sector. Biotech firms should more firmly establish themselves in factors relating to patents, management, innovative ideas, and commercial potential. Also Indian biotech firms need to improve the quality of research to orient the application of this technology towards industrial sector to increase the interests of the venture capital funds. Ultimately there is a need to develop a special class of entrepreneurs to exploit the big potential of biotechnology applications in the industrial sector for its capability to become a cheaper technology for production of critical inputs for the economic development. Venture capital has been a remarkable catalyst of entrepreneurial activity in many developed countries. VC-backed firms are major contributors to the growth of the economy. It has led to significant growth in industry and innovation. The prospects for the triumph of Indian VC industry in the biotech sector are no less than humongous. It is up to the VC community to evolve a strategy to seize the optimal opportunity that biotechnology offers today and be partners in success. ]]> <![CDATA[Australia is a popular place for clinical trials]]> https://biospectrumindia.com/news/95/1101/australia-is-a-popular-place-for-clinical-trials.html https://biospectrumindia.com/news/95/1101/australia-is-a-popular-place-for-clinical-trials.html Tue, 11 Oct 2005 14:28:00 +0530 New Page 1 "Australia is a popular place for clinical trials" - Garry Draffin, CEO, Invest Australia Invest Australia is Australia's national inward investment agency, set up by the Federal Government in 1997 to promote inward investment. Invest Australia advises companies from overseas about Australia's competitive advantages as an investment destination and actively facilitates investment projects into Australia. Garry Draffin, CEO, Invest Australia, shares his views on the opportunities and the possibilities. What is Australia's offering to the Indian Biotechs? Australia is generally recognized as the number one biotech destination in the Asia- Pacific region. There are over 400 registered biotech companies in Australia. And several of them are floated on the Australian Stock Exchange. The market capitalization at the moment is A$30 billion. The total funds raised in the biotech sector in 2004 were A$534 million, of which A$311 million was follow-on capital raisings. Australian biotechnology organizations had 315 therapeutic products under development by the end of December 2004, excluding those being trialed by overseas companies. The Australian Government invested around A$1.29 billion in biotechnology related R&D in 2003. So it is a very vibrant and growing sector. However, the issue that needs to be addressed is increasing Australia's focus on this sector through increased cooperation with India. At this moment Australian companies instinctly turn to the US for partnerships and collaborations. India is probably the second big destination for biotech in the Asia Pacific region. And I am absolutely sure that India intends to become the #1 destination. One of the ways to do this is through closer collaboration with Australia. We have a lot of capabilities and can add to the intellectual horsepower that exists in India. About 45 percent of the companies in Australia are engaged in therapeutic work and of the rest nearly 16 percent would be in the agricultural biotech and 15 percent in diagnostics. India and Australia are both looking at these areas. One of the other areas that is worthwhile bearing in mind is that Australia has recently signed a free trade agreement with the US. The agreement creates a favorable climate for biotech collaboration between the US and Australia. That may be an advantageous way for the Indian companies to enter the US. Indian companies can establish arrangements with the companies in Australia, which have a vehicle to engage with the US market. Are you actively promoting partnerships between the tier II and III companies in the life sciences sector? Yes we are. Australia has some significant advantages in terms of clinical research and is a popular place for clinical trials. The Australian government has put a lot of money into the innovation programmes. In 2003, the Government provided A$1.29 billion in public biotech spending. It has committed about A$150 million to biotechnology R&D across its programs and fellowships. The list of companies that are working in this program include leading players from the world. Can Indian companies collaborate under these programs and also get incentives and concessions? Yes they can. However, the incentives apply to companies registered and developing products in Australia. The key issue for Indian companies wanting to participate in the incentives provided by the Australian government is to have resources and partnerships on the ground in Australia. Having said that the consultancies and partnership take place worldwide. How do we get them to shake hands? It's all the usual things. For example, AusBiotech 2005 National Conference is being held in Perth during November. And am hoping a good sizeable delegation from India comes down. We recently hosted the Forbes Conference in Sydney and a large Indian delegation came there. Several major pharma and biotech companies too came on that mission. So it is a matter of knocking on doors to make sure that people are aware of what the opportunities are and facilitate the market to move. In my visits to India, I am trying to promote the profile of the Australian biotech. Further, all the state governments are active in India. West Australia is clearly here. South Australia is opening an office in Chennai. Queensland is here in Bangalore. Victoria is in Bangalore. So people are creating the awareness and things are starting to happen. What is the general perception about the Indian life sciences companies in Australia? The general perception unfortunately is low. There is not much of knowledge about what is happening in India in the Australian market. Australia is not good at promoting its attributes in India and Indian companies are not promoting their skill sets in Australia either. There has to be more of this two-way engagement. N Suresh with Ch. Srinivas Rao PAKISTAN Pakistan formulates biotech policy The National Commission on Biotechnology (NCB) has formulated a draft national biotechnology policy and action plan and presented it to the Ministry of Science and Technology to promote the uses and applications of new biotechnology both in agriculture and healthcare in Pakistan. Speaking to BioSpectrum, Dr Anwar Nasim, chairman, NCB during his visit to Mumbai, said, "Pakistan too is keen to benefit from biotechnology. The ministry of science and technology has been funding many projects related to biotechnology. It has already invested more than Rs 1 billion in various research projects. About 27 government institutes/organizations and universities are working in the field of biotechnology. " He further said, "The NCB has been doing lot of activities to promote biotechnology in Pakistan. The NCB has already organized many seminars/workshops in different cities. The commission has organized national conferences on agriculture biotechnology, industrial and environment biotechnology and health biotechnology, international conference on biotechnology for salinity and drought tolerance in plants and a workshop on understanding the gender dimensions of biotechnology research and application at different places." taiwan DCB forms a Gene Vector Consortium The Development Center for Biotechnology (DCB), a non-profit, government-funded R&D institute in Taiwan, recently formed an international consortium of companies involved in the field of gene vector technology-based drug development, called the Gene Vector Consortium. The DCB has been working on building up its expertise in gene vector technology. Integrating its expertise in gene vector technology and production with local and international companies having existing capabilities in this field, the DCB invited North Carolina, US-based AsklÃªpios Biopharmaceutical, Inc., as well as two Taiwan-based companies-contract biopharmaceutical manufacturer Mycenax Biotech, Inc., and CESCO Bioengineering Co. Ltd, to jointly develop contract manufacturing services for gene vectors. Source: www.biotecheast.com UNITED KINGDOM BIA to contribute to 'fair' market study "The BioIndustry Association (BIA) looks forward to representing its bioscience member companies in contributing to the Office of Fair Trading (OFT) market study and enabling our member experience to add value to the study," said Aisling Burnand, chief executive officer of the BIA. The OFT study will assess whether the Pharmaceutical Price Regulation Scheme (PPRS) provides an effective way of meeting its stated aims such as secure the provision of safe and effective medicines for the NHS at reasonable prices; promote a strong and profitable pharmaceutical industry capable of such sustained research and development expenditure as should lead to the future availability of new and improved medicines; encourage the efficient and competitive development and supply of medicines to pharmaceutical markets in this and other countries. The current Pharmaceutical Price Regulation Scheme agreement has a disproportionate impact on innovative bioscience companies that are highly likely to have small portfolios, often limited to one or two products. Larger pharmaceutical companies have the option of making price cuts across a portfolio while maintaining prices on individual products and this option is not open to smaller bioscience companies. Therefore smaller companies with fewer products are at a disadvantage to larger companies with larger portfolios. "The BIA's main concern with the Pharmaceutical Price Regulation Scheme is the disproportionate impact it has on innovative bioscience companies, which have often just one or two marketed products, and are therefore unable to split price cuts across a portfolio. We will be making this point constructively in our communications with the OFT, " noted Aisling Burnand. Source: www.bioindustry.org AMERICA "Biomedical research has taken a backseat" "Biomedical research has taken a backseat to the pressure tactics of animal rights extremists. Ethical animal research has played a vital role in virtually every major medical advance of the last century â€“ for both human and animal health. This research is invaluable in the development of life-extending treatments for people, as wells as cats, dogs, farm animals, wildlife and endangered species," said James C Greenwood, president and CEO of the Biotechnology Industry Organization (BIO). Reacting to the recent decision of the New York Stock Exchange (NYSE) to postpone the listing of Life Sciences Research (Huntingdon Life Sciences) on NYSE, in a letter addressed to the NYSE chairman, John Thain and president, Catherine Kinney, he said, "I want to covey a collective disappointment of the biotechnology industry to the NYSE's reaction to threats from terrorists claiming their actions on behalf of the rights of animals." He further noted, "BIO members stand together in our opposition to any efforts that would hinder our ability to develop and produce products that are safe for patients, consumers, populations, pets, livestock, wildlife and ecosystems. The ability to conduct humane and responsible animal- based research must be preserved to help conquer disease, alleviate suffering and improve the quality of life. Biotechnology companies have depended on this research to develop more than 200 drugs and vaccines approved by FDA, helping 325 million people worldwide and preventing incalculable human suffering. In Senate testimony this year, the Federal Bureau of Investigation (FBI) stated that animal rights extremists are recognized as the nation's top domestic terrorism threat. These groups have committed more than 1,100 criminal acts in the United States since 1976, resulting in damages conservatively estimated at approximately $110 million. Source: www.bio.org france French investors for creation of JEIC status Fourteen specialized high-tech venture-capital funds, representing almost 7 billion euros in investment capacity and sitting on the boards of directors of several hundred innovative SMEs, are launching a solemn appeal to Prime Minister of France for the establishment of the status of Jeune Entreprise Innovante CotÃ©e (JEIC)- Young Listed Innovative Enterprise in 2006. "In the absence of JEIC status and a lucrative stock market, venture-capital investors will reduce their investment in French SMEs and many SMEs will be sold to large groups or to overseas SMEs", said Philippe Pouletty, chairman of France Biotech and of the Strategic Council for Innovation. Intended to benefit the last link in the chain of financing to innovative SMEs, JEIC status would be granted for eight years following stock market listing to any innovative SME that uses over 10 percent of its expenditure on R&D, has fewer than 2,000 employees and a turnover of less than 150 million euros. JEIC status would attract French investors through targeted tax benefits favoring research and development and the growth of SMEs: shareholders would be exempt from capital gains tax, inheritance tax and wealth tax on their JEIC securities. For a modest budget cost, recently estimated by the Ministry of Industry and the SCI at only 25 million euros per annum, JEIC status will leverage French private and international investment and will enable world champions to emerge among our SMEs with major potential. Source: www.france-biotech.org new zealand BioAgri improves farm productivity in New Zealand New Zealand's agritech sector has been at the forefront of technological developments, which have allowed significant improvements in farm productivity. A report released by the National Bank of New Zealand highlighted the role played by the agritech sector in maintaining agriculture's contribution to New Zealand's economy. The report said the sector is also closely aligned with improvements in marketing and an emphasis on value added which have contributed better offshore returns for New Zealand's still predominately agricultural exports. Through three channels the sector has been contributing to the New Zealand economy. The channels include; by generating direct revenue and export earnings in its own right; from products and services facilitating 'best practice' farm management techniques; and allowing significant value to be extracted from farm products by identifying and meeting consumer preferences. However, the report said many of businesses in the sector are small and lack the resources and ability to specialize of larger firms. It has identified industry body New Zealand Agritech Incorporated as an avenue to capture the critical mass required to address collective needs. The society's principal involvement is in co-operative marketing promotions in overseas markets as an avenue for members to establish and strengthen international distribution networks for their goods and services. Source: www.nzbio.org.nz sINGAPORE Public sector R&D budget on the rise in Singapore The budget for public sector R&D in Singapore has more than doubled to almost S$12 billion over the next five years, as part of a strategy for transforming Singapore into a knowledge-based economy. Singapore's total public sector R&D budget was about S$5 billion for FY2001 to FY2005, and that figure excludes defense research. The Cabinet has approved Ministerial Committee for R&D (MCRD)'s recommendations that this be raised to S$12 billion for FY2006 to FY2010. Five thrusts that would propel future economic growth include: to provide more resources, to focus on niche areas, to achieve a balance of investigator-led and mission-oriented research, to encourage more private sector research, and to strengthen the bridge between R&D and business. Source: www.biomed-singapore.com ]]> <![CDATA[The Reality Byte]]> https://biospectrumindia.com/news/95/1020/the-reality-byte.html https://biospectrumindia.com/news/95/1020/the-reality-byte.html Tue, 11 Oct 2005 14:26:00 +0530 The Reality Byte The Reality Byte While reports suggest that bioinformatics is the next sunrise industry, many small and medium companies have either closed or joined hands with leading companies in the same space. Pune-based SciNova Technologies shut down in July this year. Set up in 2002 with an investment of Rs 25 lakh and 10 qualified staff with six having masters, two doctoral fellows, it had developed a couple of products. It also had the backing of a pharma contract manufacturing company with a presence in other countries. Despite all this, it was not able to market its products. The huge running cost and nascent market for bioinformatics tools forced the promoter to take this extreme step. However, this small company managed to do business of about Rs 25 lakh in 2003-04 and then increased to Rs 45 lakh the following year. Ultimately, the company downed its shutters in July 2005. After the closure, Rajeev Gangal, founder and chief scientific officer, SciNova Technologies said, "The marketing team did speak to some companies for the deals. But they did not materialize or would have taken a long time to materialize after due diligence. Our products were also very complex and were still in an alpha stage. The industry response to our products was good, but none seemed willing to contribute to its development by buying an early license." This is one example. With a few exceptions, others are passing through a similar situation. They are finding it difficult to manage or run the show. Hence they are following various business models so as to be in the business. Some are focusing on education and training with a few others into developing real bioinformatics tools. Contrastingly, the reports are projecting a different picture. According to a NASSCOM-KPMG study, the biotech industry's R&D and services will reach a turnover of $3 billion by 2010 and the bioinformatics market will touch $2 billion. Indian companies have become providers of biotech information to clients around the world. Sequencing genes and delivering genomic information for big pharma companies is the next boom industry. India has become one of the prime forces in the development and manufacture of genomic drugs. There are about 170 biotech companies in India. Strategies to overcome challenges In spite of the growing interests and strong potential, the Indian bioinformatics sector faces challenges in standardization, integration and interoperability, both in terms of technology and market capturing. To overcome these challenges Dr Jayashri Mapari, senior research analyst, healthcare practice, Frost & Sullivan has suggested some strategic steps. She noted certain areas that can be ramped up for enhancing capabilities and making forays into the global bioinformatics space. Some of the steps include: â€¢ Compressing product development cycles by minimizing the production time and maximizing the time between introduction and obsolescence. â€¢ Constant watch on market demand and technological advances. â€¢ Improving data quality in terms of reproducibility and accuracy so that high-throughput is coupled with high-quality data. â€¢ Better and more integrated systems, algorithms, annotation protocols, and user interfaces must be developed for accurate interpretation of available information. â€¢ Different systems developed by different companies must be equally accessible to the researcher. â€¢ Develop more robust and standardized data annotations. â€¢ Improve the existing algorithms for effective filtering, visualization and analysis of the data. â€¢ Bring it all together in one easy to use system. â€¢ Evolve fiscal and regulatory policies so as to cut down product development, product commercialization lifecycles. â€¢ Stronger initiatives on the part of the government in terms of funding, infrastructure development support and effective regulatory policies. However, Dr M Vidyasagar, executive vice president, Tata Consultancy Services, Hyderbad, observed, "I have never been convinced that India is a large market for bioinformatics products (tools), or even for bioinformatics services. Bioinformatics has the potential to make a large impact when a company is attempting to do "ab initio" drug discovery. Much of the pharmaceutical industry in India is focused on experimenting with variations of existing, validated drugs." Meanwhile pharmaceutical companies across the globe including the leading Indian pharma players are now under immense pressure to increase their drug research productivity owing to declining drug pipelines, a lack of recent blockbuster drugs and currently available blockbuster drugs going off patent. Moreover, a large number of drug candidates fail to make it to the final approval phase. As a result, drug discovery companies are compelled to incorporate tools that can improve their productivity and reduce R&D expenditure. Bioinformatics would aid companies in reducing the time involved in drug discovery. As drug discovery companies actively pursue these tools, the bioinformatics market is anticipated to be one of the most exciting segments in the total drug discovery market. India's entry into the product patent regime in 2005 has in recent times boosted this sector. Many leading Indian pharmaceutical companies are investing on R&D to take an early lead in the new patent regime. But are they looking at local companies? The answer is 'yes' as well as 'no'. The bioinformatics companies have their own reasons. Sowmyanarayan, manager - business development and alliances, Strand Life Sciences, Bangalore, said, "The term bioinformatics tools refer to a broad range of solutions/tools. Among all the tools that companies might be working on, only a few will be relevant to Indian pharma and biotech. This is because there are multiple ways/methodology to approach drug discovery and development. This being the case, the overall revenue contribution of the Indian market attributable to these tools will be low. But it does not translate to difficulty in sales. At least this is the case with our suite of offering and we have had successes both nationally and internationally." Sharing similar views Anuradha Acharya,CEO, Ocimum Biosolutions said, " First of all, I doubt it that Indian pharma or biotech companies are buying too many bioinformatics tools. There are a few Indian companies and they do buy from us. So I can't say they look only at buying from multinationals. We have customers like Ranbaxy, NFCL, JK Agri, Zydus, Nicholas Piramal and SRMC who have bought our tools. However, it is difficult to sell to Indian companies. The returns are not that high. Selling is not very lucrative for most companies. That might be a reason why most Indian companies are not actively selling to the local clients. However, we at Ocimum believe that there is a market in India, which is going to come up very soon and will be there when Indian companies are ready to buy." Disagreeing to the fact that Indian pharma and biotech companies are looking at bioinformatics tools, Dr Vidyasagar observed, "The multinationals are targeting the academic and R&D market much more than the commercial market. Another point is that the mature scientists in Indian companies that are potential users of the bioinformatics tools, are accustomed to the multinational software packages from their student days. So there is a tendency to gravitate towards the multinationals. To change the situation, it is necessary to capture the student/academic community first. High quality bioinformatics tools from Indian companies are only now becoming available and in the future we will see them being used increasingly, not just in India but around the world," he added. Is it brighter? Although Indian bioinformatics companies are selling the tools, pharma and biotech companies are looking for tools from multinationals mainly because they get a free version and are not getting a standard product. Hence they have to face competition from the global players. Dr Vidyasagar said, " In bioinformatics as in anything else, the Indian companies will face competition from overseas companies. For instance, TCS (not in life sciences but overall) faces competition from the likes of IBM, Accenture, etc. Ultimately we have to play to our strengths which are many, whether in IT as a whole or in the narrow area of bioinformatics. As far as our own bioinformatics initiative, we have broadened the scope beyond the traditional areas of bioinformatics to all aspects of the drug discovery value chain. We expect to show very significant growth in all aspects, be it pure revenues, IP creation, or thought leadership." Indian bioinformatics market scenario The Indian bioinformatics market pegged at about Rs 100 crore (with 40:60 percent ratio of local and export market) was expected to grow to $120 million by 2006 and likely to take a major pie in the global bioinformatics sector in next few years. At present there are about 45 companies in this space mainly based in southern cities like Bangalore, the IT capital of India, Chennai and Hyderabad. About 20 percent of them are based in Delhi and a very few in Pune, the knowledge center. Of these about 35 companies actually involved in developing bioinformatics tools and products while rest are into marketing of the tools. He added, "The 'bioinformatics' that consists of activities such as database curation, literature search, etc. is indeed growing very rapidly, possibly at much more than 25 to 30 percent per year. However, the large value addition in bioinformatics is going to be in Indian companies assisting overseas biotech or pharma companies in doing ab initio drug discovery. "I am not sure about the number but the industry is growing at a good rate. Pharma-biotech companies realize the value of /in silico /tools. But they only want to associate with companies that can deliver solutions that work. There has been a lot of hype around what /in silico/ tools can deliver. It is essential to set appropriate expectations on the potential of tools," said Sowmyanarayan. The market is fairly small at this stage and 25-30 percent is not that big a growth. But it will eventually stabilize with 2-3 players in the market. Like in every segment, the market can only support a few strong players. "The closure of SciNova was sad, but it takes a reasonably long time to create a branded product like Accelrys to really succeed. Hundreds of bioinformatics companies have shut down in the US. It doesn't mean that the market doesn't exist, its just that only a few survive to be successful product companies and there will be companies in India that will survive, especially those that have survived for over five years," opined Anuradha Acharya. The sector will consolidate in the next couple of years and the few companies that are offering real value will survive. The surviving companies will tap the potential market as most of the Indian players have created their own niche and have been fairly successful in tapping that. Hence the future for the Indian players is still bright and the entry of multinationals will not significantly alter the market scenario. Narayan Kulkarni ]]> <![CDATA[Technologies transferred / launched during 2003-2005]]> https://biospectrumindia.com/news/95/1391/technologies-transferred-launched-during-2003-2005.html https://biospectrumindia.com/news/95/1391/technologies-transferred-launched-during-2003-2005.html Tue, 11 Oct 2005 14:23:00 +0530 Bioresearch ramps up in public labs Technologies transferred / launched during 2003-2005 Title of the technology Institute where developed Technology transferred to Mycorrhiza biofertilizer mass TERI, New Delhi M/s SHEEL Bio-tech, New Delhi production technology Technology for production of high CFTRI, Mysore protein biscuits A polyclonal antibody-based 1. Centre for Biotechnology, Poseidon Biotech, Chennai- an immunodiagnostic Anna University and 2. C. Abdul aquaculture-based company. assay for the detection of white Hakeem College, spot syndrome virus - a simple Melvishram diagnostic test kit The technology for NEERI, Nagpur The pilot plant commissionedat biological deodorization of gaseous Jubilant Organosys Ltd., Gajraula. effluents has been demonstrated at pilot plant level. DNA/MVA based HIV-I Subtype AIIMS, New Delhi Under negotiation for transfer to 'C' candidate vaccine PanaceaBiotec Ltd., New Delhi Farmer level monoclonal antibody College of Fisheries, UAS Mangalore Being transferred to GenexBiotech, Goa based kit for the detection of white forcommercialization. spot shrimp virus Microbial desulphurisation of NEERI, Nagpur Vam Organics Chemical Ltd.,UP fossil fuels and biogas Technologies for nutritional CFTRI, Mysore Suresh Exports, Bangalore;Mysore enrichment â€“ A large-scale Chikbidarkal Farms, Bangalore; production of oyster mushrooms Growtech Agro (I) Ltd.,Hyderabad; KarnatakaHorticulture Dept., Mysore;GAMS & Sons Industries, Burdwan, West Bengal;Mizoram Mushroom ProductionUnit, Mizoram; MushroomCanning Unit, Ahmednagar Technologies for nutritional CFTRI, Mysore Best Bilt Bio-techMysore Ltd., enrichment â€“ Spirulina as Nanjangud; ShamalAgrotech Pvt Ltd., nutrient supplement Jalgaon;Wonder Herbs Pvt. Ltd., Bhopal Tissue culture protocol of Kerala Agricultural University, Growmore Biotech, Hosur black pepper Thrissur Technology /Processes for the NII, New Delhi Panacea Biotech Ltd.,New Delhi Lalru, production of tissue culture derived, Punjab formalin inactivatedJapanese Encephalitiscandidate vaccine An ELISA test system to detect JEV Jointly by NIMHANS, Bangalore; KGMC, M/s XCyton Diagnostics Ltd.,Bangalore IgM antibodies in CSF of patients Lucknow and NII, New Delhi Multi-epitope protein-based ICGEB Tulip Group of Cos., HCV detection Biopesticidal formulation ICGEB Nirmal Organo Biotech Technology transfer Mass production technologies of several biocontrol agents/biopesticides have been developed and standardized. Fermentation based mass production technology of Trichoderma viride, has been transferred to Prathista Industries Ltd in Nalgonda, Andhra Pradesh. Myrothecium verrucaria, a potential biopesiticides developed through a collaborative project implemented at NCL, Pune and RRL, Jammu is being up scaled and fine tuned for commercialization. The toxicological data is being generated and negotiations are being made for the technology transfer to the industry. The commercial viability of Beauvaria bassiana and Verticilium lecanii as a potential biopesticides against tea pest is being pursued at AAU, Assam. Mechanized system for mass production/ rearing has been developed for Trichogramma and Cocyra cephaoinca at IARI, New Delhi and technology is ready for transfer. At AMU, Aligarh, the powder formulation of Trichoderma harzaniam, Pochonia clamidosporia, Pseudomonas fluorescence have been developed, field-tested and techno-economic feasibility has been established. The culture protocols for large-scale production of the algae Dunaliella salina and D. bardawil have been developed and methods have been standardized for isolation of stable and high quality b-carotene. The protocol is ready for transfer to the industry. Food Biotechnology AIIMS, New Delhi; NDRI Karnal; RRL Jammu; CFTRI, Mysore; and ITRC Lucknow are developing rapid PCR diagnostic kits for the detection of various food borne pathogens like E. coli, Salmonella and Shigella spp. At CFTRI, Mysore, efforts are on for the technology transfer of high protein biscuits containing 14 percent protein with high protein digestibility. The validation of PCR and ELISA assays developed to detect transgenic traits in genetically modified foods is being carried out in five research laboratories and the process for production of astaxanthin from green alga Haematococcus pluvialis has been perfected. This is just a representative snapshot of the research activity is happening in the Indian public laboratories. With the right thrust, regulatory and policy support and infrastructure facilities the number of technologies emerging from the Indian labs could increase multifold and the resulting products would have a lasting impact on the people. Rolly Dureha ]]> <![CDATA[Bioresearch ramps up in public labs]]> https://biospectrumindia.com/news/95/2246/bioresearch-ramps-up-in-public-labs.html https://biospectrumindia.com/news/95/2246/bioresearch-ramps-up-in-public-labs.html Tue, 11 Oct 2005 09:40:00 +0530 Bioresearch ramps up in public labs Bioresearch ramps up in public labs Science and technology research in India is mostly government-sponsored. Over 85 percent of Indian scientific research currently happens in the public-funded laboratories which have been silently conducting excellent research. India has a huge infrastructure and research network in place driven by nodal agencies like Indian Council of Agricultural Research (ICAR), Council of Scientific and Industrial Research (CSIR), Indian Council of Medical Research (ICMR) and the Department of Biotechnology (DBT). A number of institutes falling under these agencies have a focused research mandate in biotechnology and they have been doing excellent basic and applied research. For instance, till 2002, about 45 technologies were transferred by DBT to the industry. During the last three years, nearly 20 more process transfers took place as a result of which about seven products have been launched in the market. Six transgenic crops (chick pea, groundnut, mustard, pigeonpea, rice and tomato) developed by agriresearch institutes like the ICRISAT, Hyderabad and IARI, New Delhi, were approved for limited field trials during last year. The CSIR has over 200 patents in the area of biotechnology and it has been constantly among the top three in the list of Top 50 PCT filers brought out by the World Intellectual Property Organization (WIPO) for the developing countries. In fact it has maintained a 30-40 percent share of the US patents granted to Indians in India. Till March 2004, the total number of biotech patents filed through the DBT was 124 of which 13 have been granted. During 2004-05, the DBT received 17 patent applications for filing and during this period one US and 3 Indian patents were granted taking the total number of patents granted so far to 17. The R&D spend of DBT alone on various projects was Rs 132.5 crore during 2004-05 and in the current year, the budget earmarked for research is Rs 164 crore. The Research Hubs DBT Centers of Excellence DBT, the nodal biotech agency in the country has set up seven autonomous institutes in the frontier areas of modern biology over a period of time, which facilitate focused research. These are Centre for DNA Fingerprinting and Diagnostics (CDFD), Hyderabad; Institute of Bioresources and Sustainable Development (IBSD), Imphal; Institute of Life Sciences (ILS), Bhubaneswar; National Brain Research Centre (NBRC), Manesar; National Centre for Cell Science (NCCS), Pune; National Centre for Plant Genome Research (NCPGR), New Delhi; and National Institute of Immunology (NII), New Delhi. The major research thrusts at NII, New Delhi are directed towards molecular design, host pathogen interactions and immune physiology. It has developed diagnostic kits for detection of pregnancy, typhoid, hepatitis B and amoebiasis. The institute has developed, validated, and transferred the technology of two pregnancy kits, typhoid, hepatitis B, amoebic liver abscess and intestinal amoebiasis kits to the industry. NII has filed three patents in India and one in PCT while the NBRC, Manesar, a relatively young institute, is focused on neuroscience research. Says Prof Vijayalakshmi Ravindranath, director, NBRC, "This is the first institute in India devoted to the development and promotion of basic neuroscience. NBRC is an 'Apex Coordination Center' for neuroscience research in India and the major research areas include computational neuroscience, system and cognitive neuroscience, stem cell research, developmental neurobiology and basic research towards understanding of neurological and psychiatric disorders". The research areas being pursued at CDFD, Hyderabad include genetics, epidemiology and diagnostics of childhood blindness; cancer biology and metastasis of HPV induced cervical cancer; structural and functional genomics of Mycobacterium tuberculosis; silkworm genome sequencing partnership at the global level; sequencing of the Mycobacterium W and computational biology. The NCPGR, New Delhi carries out research related to the nutritional, structural, and functional genomics aspects of various plant systems with the ultimate goal to manipulate plant genes to breed improved varieties of crop plants. The Centre is currently engaged in plant genomic research with focus on structural and functional genomics for crops like chickpea, catharanthus, potato, tomato, lathyrus, rice, sweet potato, and cassava. The NCCS serves as a National Cell Repository for cell lines and hybridomas and has supplied 1017 cell lines to 163 scientific institutes in India during the last year. It is involved in cell biology, cancer biology, immunology, diabetes, signal transduction, and gene regulation research. During the last few years, the NCCS has drawn special attention towards stem cell research in India. In the stem cell biology area, it has generated stable embryonic cell clones, which have the potential for neural cell lineage. The institute has obtained two US patents and filed applications for six more patents. CSIR Institutes With a network of 38 laboratories and 39 regional centers, the Council for Scientific and Industrial Research (CSIR) is one of the premier scientific industrial research and development organizations in the country. About eleven CSIR institutions namely the Institute of Genomics and Integrative Biology (IGIB), Delhi; Centre for Cellular and Molecular Biology (CCMB), Hyderabad; Central Drug Research Institute (CDRI), Lucknow; Central Food Technological Research Institute (CFTRI), Mysore; Central Institute of Medicinal and Aromatic Plants (CIMAP), Lucknow; Institute of Himalayan Bioresource Technology (IHBT), Palampur; Indian Institute of Chemical Biology (IICB), Kolkata; Institute of Microbial Technology (IMT), Chandigarh; Industrial Toxicology Research Centre (ITRC), Lucknow; National Botanical Research Institute (NBRI), Lucknow; and Regional Research Laboratory, Jammu (RRL-Jammu) have been carrying out focused research in biological sciences. Five other institutes namely, Central Leather Research Institute (CLRI), Chennai; Central Salt & Marine Chemicals Research Institute (CSMCRI), Bhavnagar; National Chemical Laboratory (NCL), Pune; National Environmental Engineering Research Institute (NEERI), Nagpur and National Institute of Oceanography (NIO) also carry out valuable biosciences research. The development of "BioSuite", a bioinformatics software and "Sudoterb", a new molecule for the treatment of tuberculosis are some of the recent CSIR success stories under the NMITLI scheme. Agri biotechnology, genetic manipulation of microbes, molecular genetics, control of gene expressions and recombinant DNA products are some of the important areas of research in this wide spectrum of institutes. For example, IMTECH, Chandigarh a constituent laboratory of CSIR, carries focused R&D programs in four broad areas of microbial biotechnology: molecular biology and microbial genetics; protein science and engineering; fermentation technology and applied microbiology; and cell biology and immunology. According to Dr Girish Sahni, director IMTECH, "The institute has an International Depository Authority (IDA) facility and has a collection of 10,000 microbes and more than 13500 cultures have been supplied to the academic and research institutes and the industry. Our Microbial Type Culture Collection holds 70 cultures for IDA deposit, 96 for filing national patents and nine under safe deposit." Elaborating on the achievements of the institute, Dr Sahni said, "Some of our selected achievements include: â€¢ A rapid easy and sensitive means of screening steroidal agonists and a function based assay system for detection of mutation in a steroid receptor gene that impairs normal receptor function â€¢ A novel method to discover functions of genes, able to confer only subtle or difficult- to-screen phenotypes to yeast â€¢ Studies on the structural elements in streptokinse (SK) that confer the high affinity to this protein for human plasminogen â€¢ A new, protein-engineered version of streptokinase with improved clot specificity â€¢ An ABC transporter that could be responsible for multidrug resistance in mycobacteria". "Several of our process technologies have been commercialized and the most successful of them is a branded Natural Streptokinase product, 'STPase'. The other know-hows commercialized are: Energy Efficient Alcohol Technology and a vaccine prediction software tool 'Vaxipred'," he added. About the future technology pipeline at IMTECH, he said, "In the future one of our technologies on the production of Recombinant Streptokinase and the other on Clot Specific Streptokinase are expected to be launched soon. We plan to commercialize an immunodiagnostic technology and an oral recombinant cholera vaccine as well. We have an ongoing program on generating more efficient strains of yeast, which would incorporate properties of floculation, thermo- and osmotolerant, etc. This is an on going program wherein several yeast strains with improved properties have been designed and patented. Many distilleries have shown interest in them." The total research budget for 2004-2005 for IMTECH, Chandigarh was Rs.1365 lakh, the allocation of which was done project-wise. Likewise, CDRI, Lucknow, a pioneer in biomedical research, is working on many projects related to the development of new drugs and diagnostics. According to Dr CM Gupta, Director, CDRI, "In the area of biotechnology we are presently working on the molecular biology of malaria, tuberculosis and leishmania pathogens for developing drug targets; structural and computational analysis of candidate drug molecules; fermentation technology related to development of drugs, drug intermediates, enzymes, amino acids and biotransformation products." The institute has developed diagnostic vaccines like PCR-based diagnostic probe for leishmaniasis, direct agglutination test (DAT) for leishmaniasis, LDH-based diagnosis of malaria, PCR based diagnostic probe for tuberculosis, and is currently developing a cholera vaccine. ICAR The ICAR promotes science and technology programs in agricultural research and education and carries out research directly through ICAR institutes and national research centers, project directorates and also in association with the State Agricultural Universities (SAUs) through the all India coordinated research project systems. While, the ICMR formulates, coordinates and promotes biomedical research in India. Its network consists of 21 Permanent research institutes/centers (national institutes) located in different parts of India and six regional medical centers. Autonomous institutes Some other autonomous institutes like the International Centre for Genetic Engineering and Biotechnology (ICGEB), New Delhi, Indian Institute of Science (IISc), Bangalore, The Energy and Resource Institute (TERI), New Delhi, International Crops Research Institute for the Semi-Arid Tropics (ICRISAT), Hyderabad have made important contributions in the biotechnology domain. The ICGEB, New Delhi is an independent inter-governmental organization under the UN system. According to Dr VS Chauhan, director, ICGEB, "We are looking into both human health and agriculture related plant biotechnology. With nine research groups working here, the main mandate is to do research and training in biotechnology and genetic engineering for the member countries and the developing world." About the work happening at the Center, he said, "We are working towards development of malaria vaccine closely with industry and funding from the Department of Biotechnology (DBT) and MVI. We are also working towards development of Dengue diagnostic kit. Plant groups are working towards development of transgenic cotton, biotic and abiotic stress resistance plants and biopesticides. We are also concentrating on development of plant transformation system." "We have developed an HCV diagnostic kit jointly with AIIMS, New Delhi and the technology has been transferred to XCyton and marketed by GSK. This is now available in the market. We have also developed a biopesticidal formulation along with Transgenic crops developed by Indian research institutes approved for conducting limited field trials in 2004 Crop Institute Transgene Chickpea ICRISAT, Hyderabad cry1Ac and cry1Ab Groundnut ICRISAT, Hyderabad coat protein of IPCV Mustard IARI, New Delhi Osmotin, b-carotenoidsbarnase TERI,New Delhi & barstar UDSC, New Delhi Pigeonpea ICRISAT, Hyderabad cry1Ab + SBTI Rice MSSRF, Chennai cytosolic Cu/ Zn SOD Osmania University, gene from mangrove Hyderabad species Avicennia marina gna gene Tomato IARI, New Delhi Osmotin Source: DBT PDKVV, Akola and the technology has been given to Nirmal Seeds, Pachora." The Centre has filed for three new patent applications and extended three patents to PCT. The Indian Institute of Science, Bangalore, a premier research institute has developed over 20 potential leads available for product and process development in the areas of agriculture (genetically engineered plants), healthcare (vaccines and diagnostics) and drug development, which are being pursued by the institute. Some of its significant achievements include studies on characteristics of a non-activating voltage dependent potassium channel, high-level expression of glycoprotein hormones in Pichia and interactions of monoclonal antibodies with hCG. During the year, IISc scientists made 200 publications in national and international journals and five patents were filed. Research Developments A lot of basic and applied research is currently happening in the government-funded labs. Some of the recent research work, technologies developed, transferred and being perfected for transfer in the various areas is being profiled here. ]]> <![CDATA[Biotech Age]]> https://biospectrumindia.com/news/95/2080/biotech-age.html https://biospectrumindia.com/news/95/2080/biotech-age.html Fri, 16 Sep 2005 17:28:00 +0530 Biotech Age Biotech Age Slowly and steadily, the biotech era is making its presence felt in the country. The first biotech products, human insulin and hepatitis B reached the country from the developed markets in the early 1990s. But the opening of the biotech floodgates could be attributed to the domestic manufacturers like Shantha Biotechnics, Serum Institute and Bharat Biotech in the mid-1990s. Today, the scene is vastly different. A fourth of the 50 recombinant DNA drugs approved by the US regulator are available in India. Indian regulatory agencies have approved the use of 14 biotech drugs in the past decade. At least six of these are manufactured by home-grown biotech companies. Then there are Indian companies which manufacture these on contract for global pharma firms. It is indeed a remarkable change for a sector dominated by Indian pharma companies supplying a variety of generic versions of popular pharma products. Till the acceptance of the product patent regime early in 2005, Indian pharma companies did not have to look for biotech alternatives. They have now taken up the challenge to mirror the trends in the US where the biotech drugs are better placed to get regulatory approvals than the conventional pharma products. The spirit of entrepreneurship is taking India into the brave new world of biotech with great gusto. Having realized the potential of this sector, the government too has pitched in by announcing a draft biotech policy, setting up the Mashelkar Task Force to formulate a modern and efficient regulatory regime for recombinant DNA pharma products. Of course, from an end user's perspective, these distinctions between pharma and biotech products may not matter. And that is the way it should be. But in the long run, there could be a dramatic switch to biotech drugs if some of the unmet needs are addressed by the new class drugs. Especially, if the personalized medicine era dawns on the country in the forthcoming years. This may already be happening in a small way. Many experts share the view that the pharma industry is at the end of its life cycle. Typically, every new industry has a 50-year life cycle and the pharma industry which started in the 1940s during the second world war is losing its steam. More biotech drugs were approved in the US last year than the traditional pharma drugs. The biotech is taking the pharma industry's place and the nearly 30-year biotech industry is entering its mid-life season. While pharma has become the mainstream, with no more need to canvass for the effectiveness of its products, biotech is bound to be the new industry. Public acceptance of biotech is increasing and biotech too is slowly becoming mainstream. The famous US cyclist Lance Armstrong, being accused of using a performance enhancing drug (biotech product EPO or erythropoietin) may have helped to turn the spotlight further on biotech products. The opportunity is upon the Indian biotech industry. The industry's voice is now heard clearly by the policy makers. Almost all the hurdles facing the sector will be removed soon and the biotech age may certainly dawn upon us in India.   <sureshn@cybermedia.co.in> ]]> <![CDATA["Sponsors are co-investors in Manipal AcuNova"]]> https://biospectrumindia.com/news/95/1024/sponsors-are-co-investors-in-manipal-acunova.html https://biospectrumindia.com/news/95/1024/sponsors-are-co-investors-in-manipal-acunova.html Fri, 16 Sep 2005 13:08:00 +0530 ]]> <![CDATA[Bharat Biotech to set up factory in Malaysia]]> https://biospectrumindia.com/news/95/2527/bharat-biotech-to-set-up-factory-in-malaysia.html https://biospectrumindia.com/news/95/2527/bharat-biotech-to-set-up-factory-in-malaysia.html Fri, 16 Sep 2005 12:59:00 +0530 Bharat Biotech to set up factory in Malaysia Bharat Biotech to set up factory in Malaysia Dr Krishna M Ella Hyderabad-based Bharat Biotech International Ltd will be setting up its first overseas plant in Perak, Malaysia. The new plant will be built at the pharmaceutical park in Seri Iskandar and will produce vaccines for typhoid and Hepatitis B, besides other recombinant products. Dr Krishna M Ella, chairman and managing director, Bharat Biotech said the company would be investing about RM50 million in the new plant's manufacturing, and research and development divisions. Bharat Biotech signed a memorandum of agreement with Remco Engineering and Consultancy Sdn Bhd and Perak Development Corporation (PDC) towards this. Under the joint venture, Bharat Biotech will be responsible for providing the technical expertise, while Remco Engineering will build the plant. PDC is the land owner. Dr Krishna informed that the vaccines manufactured at the Perak plant would be used to penetrate the Middle East and Asian markets, particularly Indonesia. The new plant will be ready by the middle of 2006.   ICRISAT DG meets World Bank President The Director General of the International Crops Research Institute for the Semi-Arid Tropics (ICRISAT), Dr William Dar, met the President of the World Bank, Paul Wolfowitz, in Hyderabad. Dr Dar, who is also the Chair of the Alliance Executive of the Future Harvest Centers of the Consultative Group on International Agricultural Research (CGIAR), thanked Wolfowitz for the World Bank support to the CGIAR and ICRISAT. The Bank is investing $50 million per year to the CGIAR system and such investment is very focused on the rural poor in most developing countries of the world. The CGIAR is a strategic alliance of countries, international and regional organizations, and private foundations supporting the 15 international agricultural Centers. ICRISAT is one of the 15 centers that are part of the CGIAR.   Biocon, Nobex sign research agreement Biocon Ltd and North Carolina's Nobex Corporation have announced a global research collaboration to jointly develop an oral peptide product for the treatment of cardiovascular disease. Biocon and Nobex plan to advance the oral human brain-type natriuretic peptide (hBNP) program towards an IND (Investigational New Drug) filing with the FDA (US Food and Drug Administration) in 2007 and clinical trials beginning later that year. The FDA approved administration of hBNP by continuous infusion in August 2001 for the treatment of acute congestive heart failure (CHF) in the hospital care setting. The intent of an oral hBNP would be to have a product available for chronic use, rather than only for acute use for a number of potential indications, including early-stage heart failure patients. This will herald a new paradigm for potentially multiple indications in cardiovascular therapy. "Biocon is tremendously excited at the opportunity to partner with Nobex on such an important product opportunity. By co-developing a therapeutic product such as oral hBNP of substantial clinical and market value in treating heart failure and other potential cardiovascular indications, we are taking another step towards our innovative product development strategy," said Kiran Mazumdar-Shaw, chairman and managing director, Biocon Ltd.   Eli Lilly launches insulin analogs in India Rajiv Gulati Eli Lilly & Company unveiled 'Humalog Mix', the insulin analog mixtures in India. Humalog Mix, called as designer insulin by the specialists, offers people with diabetes convenience, control and flexibility. It absorbs quickly and starts working within minutes to lower blood sugar. In fact, Humalog is the first mealtime insulin prescribed by doctors who specialize in treating diabetes, and would be available at Rs 389 per cartridge. Speaking at the launch of Humalog Mix in Mumbai, Rajiv Gulati, chairman and managing director, Eli Lilly India, said, "The challenge in diabetic care is to add quality to the patient's lives, giving them freedom of dose administration and minimize hassles in the therapy. With Humalog we aim to meet and overcome these challenges". Humalog Mix is available in three different variations: Humalog insulin lispro (rDNA origin), Humalog Mix 25 and Humalog Mix 50. These analog insulins are used as part of total glucose management that enables better long-term health. Humalog Mixtures provides both fasting and postprandial control and thus can help in preventing short term and long-term complications. Humalog Mix25 and Humalog Mix50 meet a number of patient and physician needs. They provide the convenience and mixing accuracy of pre-mixed insulins with the benefits of the unique rapid action of Humalog. Both are more physiological than human insulin mixtures and also improve postprandial blood glucose control and reduce glycemic excursions. Rajiv Gulati further said, "Future would see more and more innovation in the area drug administration, formulations all aimed at improving patients' lives and we at Lilly would endeavor to be the first ones to bring these to Indian public."   Bhan urges students to strive for innovation Dr MK Bhan Lauding the achievements of students at the annual convocation of the Institute of Bio-informatics and Applied Biotechnology (IBAB), Dr MK Bhan, secretary, DBT, government of India told them to inculcate the spirit of innovation. "It is not investment which is the problem. It is the lack of innovation and discovery that is the issue. We lack the will to persist when difficulties arise," he said. He told students to make the most of the current atmosphere in India where there is mobility, flexibility and possibility. "India had forgotten to reinvent and reengineer. But Bangalore has demonstrated the power of reinvention," he said. He called for institutions like the IBAB to try and balance the path between cooperation and competitiveness. The third annual convocation awarded certificates to post graduate students in bioinformatics and biotechniques. Prof N Yathindra, director, IBAB said that the institute was trying to formalize the degree recognition process. Scholarships and medals sponsored by biotech companies like Millipore, Sartorius and the chief minister, were awarded to meritorious students. He also hoped that the institute would move into the proposed biotech park campus - Bangalore Helix in Electronic City next year. He also requested the biotech industry to continue augmenting IBAB by providing infrastructure and support. CyberMedia News ]]> <![CDATA[List of leading UK institutions offering Biosciences Courses]]> https://biospectrumindia.com/news/95/2071/list-of-leading-uk-institutions-offering-biosciences-courses.html https://biospectrumindia.com/news/95/2071/list-of-leading-uk-institutions-offering-biosciences-courses.html Fri, 16 Sep 2005 12:55:00 +0530 List of leading UK institutions offering Biosciences Courses List of leading UK institutions offering Biosciences Courses   Institution Web site University of Abertay Dundee www.abertay.ac.uk The University of Aberdeen www.abdn.ac.uk The University of Wales, Aberystwyth www.aber.ac.uk Aston University www.aston.ac.uk University of Bath www.bath.ac.uk Bell College www.bell.ac.uk Birmingham University www.bham.ac.uk University of The West of England www.uwe.ac.uk Bristol University www.bris.ac.uk Buckingham University www.buckingham.ac.uk Cambridge University www.cam.ac.uk University of Wales Institute Cardiff www.uwic.ac.uk Cardiff University www.cf.ac.uk University of Central Lancashire www.uclan.ac.uk Coventry University www.coventry.ac.uk University of Derby www.derby.ac.uk Durham University www.dur.ac.uk East Anglia www.uea.ac.uk East London University www.uel.ac.uk University of Edinburgh www.ed.ac.uk Essex University www.essex.ac.uk Exeter University www.ex.ac.uk University of Glasgow www.gla.ac.uk Greenwich University www.gre.ac.uk Harper Adams University College www.harper-adams.ac.uk Heriot-Watt University www.hw.ac.uk University of Hertfordshire www.herts.ac.uk University of Huddersfield www.hud.ac.uk Hull University www.hull.ac.uk Imperial College London www.imperial.ac.uk Keele University www.keele.ac.uk University of Kent www.Kent.ac.uk Kingston University www.kingston.ac.uk King's College London www.kcl.ac.uk Lancaster University www.lancs.ac.uk Leeds University www.leeds.ac.uk Liverpool University www.liv.ac.uk Liverpool John Moores University www.ljmu.ac.uk London Metropolitan University www.londonmet.ac.uk Manchester University www.man.ac.uk Manchester Metropolitan University www.mmu.ac.uk Napier University www.napier.ac.uk University of Newcastle Upon Tyne www.ncl.ac.uk Northumbria University www.northumbria.ac.uk Nottingham Trent University www.ntu.ac.uk Nottingham University www.nottingham.ac.uk Open University www.open.ac.uk Oxford Brookes University www.brookes.ac.uk Oxford University www.ox.ac.uk University of Plymouth www.plymouth.ac.uk Queen's University Belfast www.qub.ac.uk University of Reading www.reading.ac.uk Robert Gordon University www.rgu.ac.uk Roehampton University www.roehampton.ac.uk Scottish Agricultural College www.sac.ac.uk Sheffield Hallam University www.shu.ac.uk University of Sheffield www.sheffield.ac.uk University of Strathclyde www.strath.ac.uk Sunderland University www.sunderland.ac.uk Surrey University www.surrey.ac.uk Sussex University www.sussex.ac.uk University of Wales, Swansea www.swan.ac.uk University of Teesside www.tees.ac.uk UCL www.ucl.ac.uk Ulster University www.ulster.ac.uk University of Wales, Bangor www.bangor.ac.uk      University of Warwick www.warwick.ac.uk University of Westminster www.wmin.ac.uk University of Wolverhampton www.wlv.ac.uk Note: A Research Assessment Exercise is conducted every four to five years and the Biological Sciences department of the major universities are ranked in order of merit. The link (http://195.194.167.103/Results/byuoa/uoa14.pdf) gives the ranking assigned to the major universities in 2001.   ]]> <![CDATA[Finding the Funding]]> https://biospectrumindia.com/news/95/1463/finding-the-funding.html https://biospectrumindia.com/news/95/1463/finding-the-funding.html Fri, 16 Sep 2005 12:53:00 +0530 Finding the Funding Finding the Funding The UK government departments and the administrations of Scotland, Wales and Northern Ireland, plus a number of other organizations, offer a variety of scholarships and other awards to help international students study in the UK. The UK offers Indian students a number of scholarships under a variety of programs. Every year, the British Council helps around 600 Indian students and professionals gain experience of the UK through a range of scholarships, training courses and bursaries. Most scholarships for study in the UK are for postgraduate courses, although limited awards are also available for undergraduate and research programs. For research programs, scholarships are also available from the UK research councils, which provide funding for Science, Technology and Humanities. When applying for a grant, a student must remember that deadlines vary. So they should be checked individually for each scheme. The application should be clear and concise and it is preferable to use the grant-making body's application form if it has one. Lastly, majority of the grant-making bodies give a partial grant, which is usually not enough to cover the full cost of a course. Some of the important scholarships available are given here. British Chevening Scholarships Chevening is the UK government's flagship scholarship scheme, funded by the Foreign and Commonwealth Office (FCO). It is managed by the British Council worldwide and supports over 2,300 international students annually to study in the UK. It is now the FCO's second largest scholarship program globally. The India program began in 1987 and has supported over 1900 Indians till date. The Chevening (India) Program offers up to 100 annual awards for Indian nationals. All the Chevening awards cover full tuition fee except in the cases where the tuition fee for a course is in excess of £12,000. The selection of candidates is carried out in India jointly by the British High Commission and the British Council. These scholarships are advertised in July or August every year for awards beginning the following academic year. For further details, visit www.britishcouncil.org.in/scholarships Scottish International Scholarship Program The Scottish Executive is offering 22 scholarships for students from China, India, South Africa, Australia, New Zealand and Singapore for a one-year masters degree program during the academic year 2006/7. The scholarship covers the tuition fee, return economy airfare and a living allowance. For further details, visit www.scotlandscholarship.com The Commonwealth Scholarship and Fellowships Plan This is an annual scheme made available to all Commonwealth countries by the Commonwealth Scholarships Commission. The India program is managed jointly by the Association of Commonwealth Universities (ACU, UK), Ministry of Human Resource Development (MHRD), Government of India, the University Grants Commission and the British Council. This program offers up to 70 awards comprising scholarchips and fellowships. The scholarships are for one-year masters, three-year doctoral or six months clinical training awards in specific subjects. Fellowships are for six months post-doctoral research. In exceptional cases applications for undergraduate study may also be considered. The preliminary selection of candidates for scholarships is carried out in India by Ministry of Human Resource Development (MHRD), Department of Education, Government of India. These scholarships are advertised in July and August for the awards beginning the following academic year. For more information visit www.education.nic.in and www.acu.ac.uk for scholarships and www.ugc.ac.in for fellowships. DFID Shared Scholarship Scheme The DFID scholarship is funded by the Department for International Development (DFID) and participating universities in the UK. This scheme assists students from developing Commonwealth countries who would benefit from higher education in Britain to the developmental advantage of their home countries. The list of participating British institutions vary from year to year and an up-to-date list of institutions is normally available from the Association of Commonwealth Universities (ACU). For details, visit www.acu.ac.uk Overseas Research Students Awards Scheme (ORSAS) The ORSAS are for postgraduate students undertaking full-time study for a higher degree as registered research students at British universities. This scheme is funded by the Department for Education and Skills and administered by Universities UK. For further details, visit the web site of the Universities UK accessible at www.universitiesuk.ac.uk/ors Royal Society Fellowships The Royal Society runs a scheme of research appointments within the UK and a series of programs encouraging exchanges of information, dialogue and visits overseas. These fellowships enable key post-doctoral scientists from a selection of countries to undertake research in the UK. For details, visit www.royalsoc.ac.uk Gates Cambridge Scholarships In the year 2000, the Gates Cambridge Trust was set up which runs an international scholarship program to enable outstanding graduate students from outside the UK to study at the University of Cambridge. Every year about 100 new scholarships are awarded. UVSS 2003-2006 In 2000, British Council India launched their first Undergraduate and Vocational Scholarship Scheme (UVSS) and its resounding success lead to its extension from 2003 to 2006. Supporting the initiative are more than sixty universities and colleges with particular interests in India, who have come together to offer scholarships, bursaries and fee reductions for school level study, further education (vocational and professional courses) and undergraduate courses. For further details, visit www.britishcouncil.org.in/scholarships Rhodes Scholarship Students admitted to the University of Oxford can avail a Rhodes scholarship. A Rhodes scholarship covers approved university and college fees and other charges for which payment is made directly to the Scholar's college. For further details, visit www.rhodesindia.com International Agencies Some International organizations, such as the United Nations Educational, Scientific and Cultural Organization (UNESCO) and the World Health Organization (WHO), also operate award schemes, mainly for students from developing countries. Further specific details can be obtained from the Indian Ministry of Education. UK Colleges and Universities Many institutions/universities in the UK have a limited number of scholarships and bursaries for international students.   Please visit respective University(ies) web sites for information. ]]> <![CDATA[The Biotech Development Strategy addresses HR issues]]> https://biospectrumindia.com/news/95/7001/the-biotech-development-strategy-addresses-hr-issues.html https://biospectrumindia.com/news/95/7001/the-biotech-development-strategy-addresses-hr-issues.html Wed, 14 Sep 2005 10:52:00 +0530 The Biotech Development Strategy addresses HR issues   The Biotech Development Strategy addresses HR issues The policy goal is to facilitate availability of scientific and technical human resource in all disciplines relevant to the life science and biotechnology sector. The key issue is the manner in which to create an effective interface across various related disciplines. The main strategic plans for HRD proposed by the Draft National Biotechnology Development Strategy are : 1. National Task Force on education and training: This would formulate model undergraduate and postgraduate curricula in life sciences keeping in view, future needs. The curricula must address the underlying need for multi-disciplinary and inter-disciplinary learning. 2. Need Assessment: There would be need assessment in 2005 for the next five years and close monitoring during the period for interim changes. A 10-year perspective plan for human resource will be prepared every five years. 3. Curriculum development: The course curricula will be reviewed and improved in consultation with industry and research establishments and standard e-learning modules will be developed for specific skill areas such as IPR, regulations and bioentreprise. Hands-on exposure to MSc biotechnology students will be enhanced through an extended industry internship as well as through short-term placements at CSIR and other appropriate national institutes. Dual degree programs in biotechnology that include regulatory matters, IPR and bio-enterprise management will be encouraged and supported by the DBT. 4. Quality improvement: An accreditation mechanism will be put in place for ensuring minimum standard of education and training at the PG and UG levels. Base requirements for teaching and laboratory infrastructure will be specified and enforced. 5. Strengthening of teaching and R&D in life sciences and biotechnology: Specific mechanisms to achieve the goal will include creation of inter-disciplinary centers of excellence with world class infrastructure in key areas; Program support to encourage inter-departmental networking; and Visiting professorship and creation of industry sponsored chairs in partnership with the DBT. 6. Attracting talent to life science and biotechnology: Bright students will be attracted to take up careers in biology and biotechnology. Summer assignments at academic and industry research laboratories will be introduced at the school level to create interest in the fields of biotechnology and biology. 7. Creating S&T leaders for the industry: The number of PhD fellowships offered by the Department of Biotechnology will be increased to 200 per annum. Public-private partnerships will be encouraged in PhD programs through creation of the 'Bio-edu-Grid'- a network of universities and industries facilitating pooling of resources. Masters degree level professionals in industry will be encouraged to undertake PhD programs while retaining their jobs through industry-university tie-ups. 8. Arresting and reversing brain drain: Outstanding young investigator grants in biotechnology will be introduced. This will provide a package including salary support, research grant, equipment and opportunities to attend national and international conferences. Information on availability of positions in education/research establishments and industries will be provided on a website to facilitate employment of scientists with specific skills at appropriate positions. A database of scientists working in different areas of biotechnology within and outside the country will be created to utilize the expertise appropriately. 9. Enabling working conditions for scientists to undertake industry-oriented research Lateral mobility of scientific personnel: Scientists working at universities and research institutions may be allowed to work in industries for commercialization of their research efforts. This could be in the form of secondment or consultancy with industry or by a sabbatical for three years during the working life of scientists Dual/adjunct faculty positions: Researchers working in university/research institutions may be allowed to hold positions in the industry and vice-versa oint salary support: Faculty employed in academic institutions may be allowed to hold positions for a period of time in which their salary is contributed both by the industry and the academic institution on a mutually agreed basis Rapid travel grants: Rapid travel grants scheme for approval within two weeks for young scientists to interact with mentors and industry collaborators would be initiated. Institute Innovation grants through the Department of Biotechnology to fund academic researchers to develop their concepts into patentable and more importantly licensable technologies. Such grants may be utilized for the purpose of providing additional infrastructure and manpower, patenting costs as well as costs related to proof of concept studies.     FICCI proposes a Biotechnology Council for India In order to develop India as a major biotechnology hub, Dr Krishna M Ella, managing director, Bharat Biotech International Ltd and chairman of FICCI biotech committee identifies human resource generation as an important aspect and suggests a series of measures to improve on its quality. Creating policy framework It is imperative to have a single national statutory body to regulate education and training in biotechnology in India. There is need to put in place a Biotechnology Council of India (BCI), an independent statutory national body, on the lines of the Medical Council of India, Dental Council of India, Pharmacy Council of India, All India Council for Technical Education and the Bar Council of India. The chief role of such a statutory body would be to ensure standardization in biotechnology education and training in the country. The BCI should be empowered to grant recognition for those institutions that meet such standards, set with reference to qualified and trained teaching staff, infrastructure, adequately equipped laboratories, etc., that are essential for a focused education in biotechnology. Biotech curriculum The biotechnology curriculum in India is still evolving. The need of the hour is to envisage a multidisciplinary curriculum that will cover all aspects of biotechnology including understanding process principles, experimentation, animal and plant technologies, bioinformatics, basics of project management, IPR issues, business values and finances in Biotechnology. There is a need to create separate modules for students and corporates, which will focus on different themes. The student course will emphasize on practical hands-on training, teaching the ethics of GLP and a fundamental know-how of BT management. There is a requirement to: Create courses on biotech equipments and technology Create short-tem and long-term courses on bio-safety Create specific specializations on patents and IPR Increase courses content on regulatory frameworks Include biotech in marketing and allied subjects Training in practical aspects There is a requirement that the state governments, DBT, along with the industry should establish instrumentation and training centers in a few key locations in different states, where students can get trained and research workers can get instrumentation services, on payment of prescribed charges, so that expensive facilities required for most of education and training in biotechnology need not be duplicated. The Indian Institute of Information Technology, Hyderabad, is based on the model. The proposed Council could actively create educational resources, self-training modules, information about advanced courses, research and fellowship opportunities, and links to various conferences and meetings around the world. It would be worthwhile to implement the following: M.Sc students should be given a six-month short-term scientific project at CSIR Laboratories Students should be encouraged to take up specializations in GMP, GLP, DCP, Validation and Q.A Promote industry-academic partnerships in establishing training centers Create vocational courses in Biotechnology Encourage women to take up vocational courses Faculty should be updated every year about current trends in industrial research Continuing education for professionals Forging industry-academia partnerships For providing an impetus to industry-academia partnerships, there is a need to create Centers like the University-Industry Research Center (UIRC) of the US. These comprise research groups whose focus is on problems that have relevance to a particular sector of industry are needed. This would represent a way where the value of academic research can be realized to benefit the institution. Creating awareness The most vital of all the current issues is increasing awareness about biotechnology. Towards the biotechnology popularization, the proposed Council could organize seminars, symposia, conferences, workshops, popular lecture series, biotechnology publications in various languages, organize biotechnology exhibitions, national science day celebrations in universities and institutions. Nurture and promote bioentrepreneurship India has the potential to become very strong in biotechnology. There has been a phenomenal increase in the number of start-up companies in this area in the last five years. Today India ranks third in Asia in patent filings. Every bioentrepreneur must thoroughly understand the grassroots features of the biotechnology sector such as research, collaboration, infrastructure, technology and commercialization capital and come up with an alternative business model to achieve success. This calls for the creation of a course in Bioentrepreneurship at the postgraduate level. Rolly Dureha ]]> <![CDATA[Thrust on Quality Education]]> https://biospectrumindia.com/news/95/1974/thrust-on-quality-education.html https://biospectrumindia.com/news/95/1974/thrust-on-quality-education.html Wed, 14 Sep 2005 10:49:00 +0530 Thrust on Quality Education Thrust on Quality Education With a wide spectrum of courses running in general and specialized sectors of biotechnology, the bottomline is the effort to breed excellence and not mediocrity in biotech education. Human capital is the key driver for global competitiveness in the biotechnology sector. This has been increasingly recognized by the Indian academicians, scientists, policy makers and industrialists, leading to concerted efforts in the area of human resource generation. In the recent years, along with increasing the talent pool, there has also been a strong focus on its quality too. Emphasis on quality The recent cancellation of registration of all the private universities in the state of Chattisgarh was a strong step taken by the Supreme Court in this direction. With the large number of private, state-funded, Centre-supported institutes in the fray, the pertinent questions being deliberated over and addressed in various forums related to biotechnology education are: How to ensure uniform and standard quality education across the vast number of biotech educational institutes; Is there need of a regulatory body to oversee the quality of education imparted? In principle, it has been acknowledged that there is a need for such a body. In fact, the Department of Biotechnology (DBT), the nodal government agency which drives, supports and provides direction for the human resource generation in the area of biotechnology has highlighted the need to set up a regulatory body for the maintenance of standard education under the name of All-India Board of Biotechnology Education under the AICTE. Many of the concerns raised by the various stakeholders regarding quality human resource generation have been addressed in the Draft National Biotechnology Development Strategy released by the DBT on March 31, 2005. The Strategy charts an integrated 10-year road map for giving impetus to the Indian biotech industry, research and development, human resources generation and infrastructure development. To address the requirement of human resource generation and further augment the existing efforts of the DBT, the development strategy has proposed some strategic action plans. Course structure The biotech curriculum is also being put under a scanner and academicians have put in a voracious demand for its restructuring according to current international trends. Dr Sameer Brahmachari, director, Institute of Genomics and Integrative Biology (IGIB) opines, "We need new approaches for learning. All countries like Singapore, Europe, US, Germany have floated, integrative courses. In these courses transdisciplinary subjects are taught together for problem solving. Integrative teaching is a new model where dis-coordinated information is given and students have to synthesize information, to integrate the knowledge to create new knowledge, new information or new conclusion. This cuts across the subjects and orients the students for information processing in biology". Many are of the view that the two-year masters programs are not equipped to impart all the relevant information. Dr K Kannan, professor, School of Biotechnology, Guru Govind Singh Indraprastha University, Delhi, comments, "The present 2-year masters programs cannot teach technology in such a short span. It requires a 4-5 year course program as it involves a whole gamut of subjects like IPR issues, marketing, biomanufacturing, biosafety, bioethics, strategic management, product formulation, clinical trials, etc. Biotech education should be structured just like that of the IITs, which take students after 10+2 to teach them the engineering technology." Adding to these views, Prof Deepak Pental, director, Delhi University, South Campus, said, "The education system has to be completely revamped. We should have BTech degrees in agricultural biotechnology, which should be offered in five universities to start with. IARI should take the lead. We should teach plant biochemistry, mapping techniques, etc and should have a strong field working environment" According to Prof Pradip Sinha, head, Biological Sciences and Bioengineering department, IIT Kanpur, "The HRD program in biotechnology has to shed its old classical format. Until now biotechnology was perceived with a narrow window of molecular biology focus. But now it is time to redefine biotechnology. For example, where do we place tissue engineering, stem cell, biomedical devices, drug design in the context of biotechnology. There is a need of interfacing with other disciplines. Secondly in the context of overall biotechnology framework, the technology concept should not be introduced early without the basic knowledge." "Ultimately every student must look for some domain specialization, they should try to see themselves as master in something. Only then they will find useful interface to get into biotech related issues," he added. The lack of adequate industry-academia interaction in the curriculum is also being looked at with concern as this prevents the students from developing a realistic industry perspective. "In the Indian universities and academic institutions, a lot of high quality academic work is going on but what is missing is the awareness and the orientation of the industry. Unless and until the manpower that is generated has the awareness of how to commercialize and what are the compulsions of commercialization, the industry cannot really pick up. We have great academics but not enough work to bring it to a commercial level. There is an obvious disconnect between the academicians and the industry," observed Dr Chandra Mittal, professor and associate chair, Department of Biotechnology, Houston Community College, US. "The students in this area in India are good but have very less exposure to the application side of things," he added. Most of these issues are being looked into and would be addressed through the National Biotechnology Development Strategy. Innovative Initiatives Recognizing the need to introduce specialized courses in biotechnology as the field matures, DBT has introduced some innovative courses recently. A one-year PG Diploma course in Genetic Engineering and Bioprocess Development was started in the MS University of Baroda in 2002-03 and a two-year MTech course in pharmaceutical biotechnology was started at the National Institute of Pharmaceutical Education & Research, Mohali in 2003-04. With India adhering to the TRIPS regime, it has become crucial to create awareness about the various IPR issues, patents in relation to biotechnology. In 2003-04, a one-year PG diploma course in Intellectual Property Rights and Biotechnology was started in the National Law School of India University, Bangalore with the support of DBT. There have been other initiatives too. For instance, the University of Pune launched a unique two-year full time MBA program in biotechnology. This was the first such program by an Indian university or institute and now many institutes are following suit. The syllabus is based on the requirements of the industry. Sixty percent of the syllabus covers the managerial aspect and about 40 percent biotechnology. Bioinformatics, an offshoot of biotechnology, has been lately attracting a lot of attention. This has led to specialized BSc/MSc and BTech courses in this branch. Bharathiar University, Coimbatore and Pune University, which has a center of excellence in Bioinformatics, offer a two-year MSc course in Bioinformatics. Recently, the Centre of Bioinformatics at IIT Delhi became a National Centre and now offers interdisciplinary MTech programs in Bioinformatics. The Indian Institute of Science (IISc), Bangalore, which is engaged in path-breaking bioresearch activities and initiatives and training is the coordinator for post doctorate fellowship program in biotechnology in the country. It has proposed for a one-year specialized training program before PhD and after the Masters course. The focus of the program is to learn the modern techniques so as to cut down the time on research. To enthuse and encourage students to go for higher education in biotechnology, in the financial year 2004-05, the DBT-JRF program was started and 43 JRFs (Junior Research Fellow) were selected from 24 universities/institutions. In addition, DBT is planning to increase the PhD fellowships to 200 per annum. Present scenario According to the Draft Biotechnlogy Strategy, today there are over a hundred national research laboratories employing thousands of scientists. There are more than 300 college level educational and training institutes across the country offering degrees and diplomas in biotechnology, bioinformatics and the biological sciences, producing nearly 500,000 students on an annual basis. More than 100 medical colleges add 17,000 medical practitioners per year. About 300,000 postgraduates and 1500 PhDs qualify in biosciences and engineering each year. Thus India has many assets in its strong pool of scientist and engineers, vast institutional network and cost effective manufacturing. The Indian biotechnology industry too is growing at a fast pace. According to BioSpectrum estimates during 2003-04, the biotech industry has grown by 39 percent and the industry revenues stood at Rs 3,265 crore ($705 million). Industry estimates project that biotechnology as a business segment for India has the potential of generating revenues to the tune of $5 billion and creating one million jobs by 2010 through products and services. According to the draft Biotech Strategy, the reliable estimates of human resource availability for the next 10 years are required. Though expert consensus indicates that there is adequate enrollment currently at the post-graduate and under-graduate levels, the quality is inconsistent. Areas such as intellectual property rights, regulatory issues and industrial training have received inadequate attention. There is a consensus that there is an urgent need to augment the number of PhD programs in life sciences and biotechnology. On this issue, Dr MK Bhan, secretary, DBT, opines, "There is a misconception that the country is lacking in skilled and qualified manpower. It is not the right kind of thinking since practical exposure in the industry is required for any qualified person to become skilled. What we are actually lacking is scientific leadership. Without effective leadership, it is not possible to create successful enterprises. Quality education is a must and those with the minds to excel will be in high demand." Creating a critical mass Largely, the credit of creating a broad talent pool focused on biotechnology and related disciplines goes to DBT. The first countrywide efforts to streamline biotech education and focus on human resource generation were by done by DBT soon after its establishment in 1986. A snapshot view of biotechnology education at various levels is given below. Bachelors level The past five-six years have seen a lot of activity happening in the biotechnology space. Due to the popularity, scope and increasing awareness about the subject, BSc Biotechnology is now being offered by a sizeable number of universities/private colleges at the undergraduate level also, like Bangalore University (Karnataka) and Chaudhary Charan Singh University, Meerut, (UP) and many other institutes are likely to introduce these courses. Although BSc Biotech is a new concept, many prestigious institutes have been offering a four-year BTech course in Biotechnology for quite some time now, like the IITs. Out of the 1,222 engineering colleges that got the AICTE's approval (All India Council of Technical Education) to offer courses in science and technology, 133 colleges are offering biotechnology as one of the courses for the academic year 2004-05. The BE in biotechnology has picked up in the last few years in states like Tamil Nadu, Karnataka and Andhra Pradesh where many biotech companies have a base. It is expected that many engineering colleges in Maharashtra, Punjab and Rajasthan would join the list of colleges offering biotech courses. Masters level The first two-year general biotechnology-teaching courses were introduced at the Masters level in top universities like Madurai Kamaraj University, Jawaharlal Nehru University, Pune University, MS University, Baroda in 1985-86 by the DBT. Subsequently the course was introduced in other universities and today there are 30 DBT supported courses running in the country. DBT also supports seven agricultural biotechnology courses; one in medical biotechnology, two in marine biotechnology, one in industrial biotechnology, three in neurosciences at the MSc level. In addition, it also supports 6 MTech courses in biochemical engineering, bioprocess technology and biotechnology. As on date, 55 post graduate teaching courses are being supported on a regular basis and 15 universities/ centers have been provided one-time financial support for strengthening their ongoing PG courses. The intake in the various post graduate courses is around 900 per year. During 2004-05 nine new proposals (2 MSc Biotechnology, 4 MSc Agricultural Biotechnology, 1 M Tech Marine Biotechnology, 1 MVSc Animal Biotechnology and 1 placement cell proposal) are in the final stages of approval by the DBT. During the year 56 post doctoral fellows were selected, 11short-term training courses were supported in multidisciplinary areas of biotechnology. And about 100 students have been placed in different industries for a 6-month training. In addition to the DBT supported postgraduate courses many state universities, private colleges and institutes also offer masters degree in biotechnology. Doctorate level The Council of Scientific and Industrial Research (CSIR), Indian Council of Medical Research (ICMR), Indian Council of Agricultural Research (ICAR) and DBT are the government agencies involved in supporting and encouraging biotechnology research and training. There are nearly 19 CSIR labs like Central Drug Research Institute, Lucknow, CFTRI, Mysore, Institute of Genomics and Integrative Biology, Delhi which are actively involved in biotech research and training. The ICAR promotes science and technology programs in agricultural research and education and carries out research directly through ICAR institutes and national research centers, project directorates and also in association with the State Agricultural Universities. The ICMR formulates, coordinates and promotes biomedical research in India. The ICMR national institutes offer opportunities for research in the area of medical biotechnology. DBT has been instrumental in the creation of the many "National Centers of Excellence" which are involved in high ended research and training in specialized areas. Like the National Institute of Immunology, New Delhi, National Center for Cell Science, Pune, Centre for DNA fingerprinting and diagnostics, Hyderabad, National Brain Research Centre, Manesar, National Centre for Plant Genomic Research, New Delhi, among others. DBT further plans to set up centers of excellence in the fields of marine biotechnology, animal biotechnology, herbal medicine, molecular medicine and bioinformatics. Apart from these, there are high caliber institutes like the Indian Institute of Science, Bangalore, Tata Institute of Fundamental Research, Mumbai, International Centre for Genetic Engineering and Biotechnology, New Delhi, which conduct sophisticated research and training in biotechnology. In order to build a successful biotechnology sector, large talent pools are required in multiple scientific disciplines such as molecular and cell biology, chemistry, physics, engineering, bioinformatics, medicine and agriculture. Ultimately the focus of the entire chain of biotech educational institutes is to create a strong pool of academic leaders/entrepreneurs/specialists, who will lead the biotech revolution through sustained innovation. ]]> <![CDATA[Supporting Biotech Education]]> https://biospectrumindia.com/news/95/2580/supporting-biotech-education.html https://biospectrumindia.com/news/95/2580/supporting-biotech-education.html Wed, 14 Sep 2005 10:46:00 +0530 Supporting Biotech Education Supporting Biotech Education Earlier, the steep cost of higher education, especially outside India, was a deterrent for many meritorious students. But the easy availability of educational loans has put the best of education virtually within everyone's reach. Higher studies in the cuttingedge area of biotechnology is the dream of many students. Getting a foreign degree in biotechnology or for that matter any other course often boils down to the issue of money. Though financial aid is an important factor to consider, the cost of the program should not hold a student back. Banks now offer a range of loan products and specialized packages that can help them get by without financially burdening their parents. Higher education abroad The cost of studying abroad is significantly higher than in India and finances require research and careful planning. The cost of education and living varies from country to country. For instance, education in the US or UK is, in general, more expensive than in Canada or Australia. And the university funding is easier to get in the United States than in the UK, Canada, Australia or New Zealand. Most students who go to Australia and the UK are self funded students. Further, even within the country, as in the US, there are substantial differences in costs, depending on whether the university is a public or a private one and again the location of the university. Costs also depend on the type and duration of the program. Generally scholarships at the undergraduate level are not easy to come by. In the absence of scholarships, banks come to the rescue of students as the foreign nationals are required to show proof of sufficient funds to cover at least the first year of their college education to apply for a student visa. Students can avail loans for study at almost any university, as banks generally check with the respective high commissions who have an accredited list of universities with them before sanctioning the loan. The time period for sanctioning the loan could be between 15-30 days. This should be kept in mind, as it is essential to have all financial documents in place when applying for the visa. Banks can also issue the capability certificate for students going abroad for higher studies since some of the foreign universities require the students to submit a certificate from their bankers about the sponsors solvency/financial capability, so as to ensure that the sponsors of the students going abroad for higher studies are capable of meeting the expenses till completion of studies. Increasing awareness In the banking sector, officials agree that since the past 4-5 years there has been a big offtake of educational loans. This trend has been fueled by changing mindset of the service class, which is opting to send their children abroad for higher education and the many upcoming private institutes, which offer more industry friendly courses albeit with a steep fee structure in the country. Although, presently most of such courses are in the engineering and management domain and very few in the life sciences segment. Experts feel that the growth in the educational loan sector has been about 100 percent though the volumes are still small. During the past year, the State Bank of India disbursed Rs 20-25 crore as educational loans in Delhi, whereas the total loan disbursed in Delhi in this segment by all banks was about Rs 50 crore. It is estimated that a total of Rs 200 crore was disbursed as educational loan in the country during the past year. Presently only about 0.5 percent of the student community is availing the loan facility from all the banks put together. Although in the life sciences segment no particular trend for availing financial aid has been noted as yet, it likely to change as the industry matures. Eligibility criteria Most of the public sector banks like the Andhra Bank, Bank of India, Bank of Maharashtra, Canara Bank, State Bank of India, Syndicate Bank, among others and some of the private banks like HSBC offer educational loan schemes. It is the public sector banks that are bullish in this segment as they envisage playing an important role in developing this market. Their aim is to build a strong relationship with the younger generation and have them as their customers in the long term. Senior bank officials advice the students to do the necessary spade work before finalizing a course, regarding its suitability, placement opportunities before availing a loan. However, the banks do not give these loans to everyone who applies for them. The first condition is that admission to professional/technical courses should be through an entrance test/selection process and the admission should be confirmed. Loans are not given for correspondence courses. And the past academic record of the loan seeker, if any should also be satisfactory. Anyone who fulfils these conditions is eligible for an educational loan which finances a range of expenses, apart from tuition fees, like: hostel, examination, library, laboratory fee; purchase of books, equipment, instruments, uniforms; caution deposit, building fund, refundable deposit supported by institution bills, receipt; travel expenses for studies abroad; purchase of computers essential for completion of the course; and any other expense required towards the completion of the course such as study tours, project work, thesis, etc. Most graduate, post-graduate, professional courses (engineering, medical, veterinary, law, dental, management), and courses recognized by the University Grants Commission, the All India Council for Technical Education, and the Indian Council for Medical Research are eligible for loans. Most banks offer a maximum of Rs 7.5 lakh for courses within India and Rs 15 lakh for courses abroad. However, based on the nature of the course and the needs of the applicant, individual banks offer a higher amount on a case-to-case basis. For example, the State Bank of India (SBI) offers a maximum loan of Rs 15 lakh for courses in India and Rs 20 lakh for studies abroad, while HSBC Bank is one of the few banks, which provides loans of upto Rs 25 lakh. Collateral With a view to encourage higher education and popularize study loans there is no security deposit for a loan sum of upto Rs 4 lakh. Generally for loans between Rs 4.0- 7.5 lakh, there is a requirement of a third party guarantee and no further tangible security is required. However, during the pre sanction survey the financial credentials, like the proof of income, bank account statements, income tax returns of the guarantor are verified. For a sum exceeding Rs 7.5 lakh, a collateral security for the full/suitable value of the loan in the form of mortgage of property, house, bonds, securities, etc is mandatory. The margin requirements on educational loans are not very rigid. It is 5 percent for studies in India and 15 percent for studies abroad for amounts exceeding Rs 4 lakh. The scholarship/assistantship promised to the students is included in margin. The margin money is calculated from time-to-time on the outstanding balance of the loan. This is brought on a year-to-year basis, as and when the disbursements are made on a pro-rata basis. Disbursement process After the mark-sheets, proof of selection/admission and scholarship to the course in question are shown to the bank officials and the amount of loan required, other sources of funding, collateral requirement and job prospects after the completion of the course are discussed, the completed loan application form along with the supporting documents is submitted. Generally, both the student and the parent/guardian act as co-applicants for the loan. The parent or guardian of the student, is required to furnish his bank account statement, tax returns of the last two years, statement of assets and liabilities and proof of income. If the bank decides to sanction the loan, then there a pre sanction survey, where the authenticity of the documents submitted, financial credentials of the co-borrower and guarantor are verified. Most of the banks take just about 5 days to a week to sanction a loan after the submission of all the relevant documents. Both the student and the guardian execute the loan document, while it is disbursed in stages as per the requirement directly to the institutions/vendors of books/equipment/ instruments. The banks do not charge a processing fee or upfront charges, although the State Bank of India requires a deposit of Rs 5,000 for education loan for studies abroad, which is adjusted in the margin money. Repayment terms The repayment period is normally five to seven years. The repayment commences one year after the completion of the course or six months after securing a job, which ever happens earlier. This is known as the moratorium period. During this period, simple interest is computed. On commencement of the repayment, interest is charged on the total outstanding balance (principal plus accrued interest) in the loan account. Accrued interest gets added to the principal amount and Equated Monthly Instalments (EMIs) are fixed on the total outstanding amount. However, a one percent interest concession may be provided if the interest is serviced during the study period when repayment holiday is on. The interest rates on these loans are usually on a floating basis. They are linked to the lending rates of the bank and are called PLR or Prime Lending Rate. While lending higher sums of money normally the banks charge one percent more than the existing PLR rate. Presently, most of the banks provide loan at the rate of 10.5 percent interest upto Rs 7.5 lakh and 11.5 percent interest on amounts more than that. In the case of non-repayment, a penal interest at the rate of 2 percent is charged for the overdue amount and the overdue period. Where as, if due to some reason, the student is not able to complete the course within the scheduled time, an extension of 1-2 years, based on the discretion of the bank given to the student. While pursuing the course, the bank tracks the academic performance of the student and they are required to submit their result sheets to the bank every year. Unlike other loans, education loans do not attract pre-payment penalty. The student can pay off the entire outstanding loan amount before the closure of the tenure too. Special packages In many cases banks also tie-up with educational institutes to offer comprehensive loan packages to students. This saves students some of the procedural hassles involved with getting the loan sanctioned. The State Bank of India has a special "SBI Scholar" scheme through which it offers in 50 identified institutes across the country like all the Indian Institute of Technology, Indian Institute of foreign Trade, Delhi College of Engineering, The All India Institute of Medical Sciences, Indian Institutes of Management direct loans to the students without the involvement of a co-borrower. Similarly the HSBC has tied up with the Indian School of Business. Allahabad Bank offers loans at interest rates, which are 200 basis points lower than the PLR for students of IIMs, IITs and professional courses. For those looking to study abroad, SBI has a special scheme as it has tie-up with Thomas Cook. Thus along with the loan, one can get instant wire transfers, foreign currency drafts, travellers' cheques, and insurance. Thus banks are working as active partners with students to help them realize their dreams and make the road to success a little smoother for them. Rolly Dureha ]]> <![CDATA[Attractive career avenues]]> https://biospectrumindia.com/news/95/2564/attractive-career-avenues.html https://biospectrumindia.com/news/95/2564/attractive-career-avenues.html Wed, 14 Sep 2005 10:43:00 +0530 Attractive career avenues Attractive career avenues The Indian Biotech industry is in an expansion mode. Today a career in biotechnology is not just attractive but challenging and rewarding too. Biotechnology is one discipline which finds applications in al- most all areas linked to life. Modern biotechnology has advanced to gene technology and beyond, and is an interdisciplinary subject covering biomedical research, microbiology, physics, chemistry, mathematics and engineering. Realizing the diverse applications of the subject, an increasing number of students are opting for studies in the biotechnology discipline. Buoyant industry The fledgling Indian biotechnology industry has been posting good growth and has now attained critical mass. The industry has crossed the $1-billion mark (Rs 4,745 crore) and recorded a 36 percent growth, according to the latest BioSpectrum-ABLE 2005 industry survey. The biotech industry as it exists today can be divided into five major segments: Biopharma, BioAgri, Bioservices, Bioindustrial and Bioinformatics. During 2004-05, all the different segments have shown healthy growth patterns. BioPharma, the single largest contributor to the total business, registered close to 30 percent growth primarily driven by the vaccines business. The Bio-Services market estimated to be Rs 425 crore recorded close to 54.6 percent growth. The BioAgri sector was the fastest growing one clocking nearly 150 percent growth. The BioIndustrial sector generated total revenues of Rs 320 crore registering 34 percent growth and the bioinformatics sector posted 25 percent growth to record a total business of Rs 100 crore. In additions there is the supporting BioSuppliers industry segment, which provides the necessary infrastructure to the biotech industry. This segment grossed a total revenue of Rs 1,230 crore and clocked 40 percent growth. The subsequent pages will outline in brief the potential, scope, key qualifications and necessary skill sets required for each of these segments. Diverse career options Biotech professionals can be employed in the areas of planning, production and management of bioprocessing industries. Employment avenues are available in research laboratories run by the government as well as the corporate sector. At the starting level, students may find work in government-based entities such as universities, research institutes or at private centers as research scientists/assistants. Alternatively they may find employment in specialized biotechnology companies or biotech-related companies such as pharmaceutical firms, food manufacturers, aquaculture and agricultural companies. New trends These days financial institutions such as banks, venture capitalists, fund management companies investing in life sciences employ analysts who have a background in biotechnology and preferably an MBA as well. Local law firms are starting to show interest in biotechnology to provide advisory consultations for Intellectual Property Rights/Patent protection for life sciences and a person with a combination of biotechnology and law would be ideal for this area. Many biotech companies are appointing MBA biotech professionals to manage and oversee the business development programs of the company. In addition, there are also opportunities for careers in biotechnology in organizations or companies that provide a supporting role for the biotech industry. Incubators are being set up in the biotech parks that are coming up in various states to encourage biotech start-up companies offer jobs for biotech graduates. Other government institutions/organizations that promote biotechnology, such as trade organizations also provide employment opportunities. BioAgri Domain experts rule the roost During 2004-05, BioAgri has been the fastest growing sector in the Indian biotechnology industry. In the bioagri sector there is a huge opportunity for improving the agricultural productivity and quality. During 2004-05, the bioagri industry registered a growth of over 150 percent and the Bt cotton seed revenues crossed Rs 250 crore. Realizing the potential of the biotech applications in agriculture, many new agri-biotech companies have come up along with many traditional seed companies branching out. This has led to new career openings. Today, instead of an all-in-one agriculturist, the field demands the services of specialists - plant molecular biologist, geneticist, biochemist, people specializing in functional genomics, proteomics, bioinformatics along with technical support and marketing staff. Courtesy: Dr Mittur N Jagadish Depending on the domain specialization of the company, the job categories vary and accordingly the qualifications required also differ. Dr Villoo Morawala-Patell, founder and CEO, Avestha Gengraine Technologies, a fully integrated biotechnology and bioinformatics company elaborates on the different job categories at Avesthagen, "These are technical, scientific, business development, administration, finance, legal, PR, clinical, product development and software programmers." The company recruits people with PhD and MSc for the science aspect of business and MBAs for business development and other management related positions, LLBs and also people specializing in patent law. Another company is this sector is Nunhems seeds, a subsidiary of Nunza BV- a Netherlands based vegetable seed company, involved in research, production and marketing of seeds throughout India. The company has a separate biotech division to address the emerging opportunities in the agri sector and employs molecular biologists and tissue culturists. "We look for MSc and PhD degree holders in molecular biology, biotechnology, tissue culture and their main responsibility is molecular analysis of the material of both lab and field studies and maintenance of tissue culture plants," explained Dr Arvind Kapur, managing director, Nunhems seeds. Monsanto India, an integrated agri solutions provider, broadly focuses on three areasâ€“agricultural chemicals like herbicides, hybrid seeds and biotech/GM crops. The job categories in the company are sales, product development, marketing (brand management), breeders, hybrid seeds production and research and development. Dr Mittur N Jagadish, director, Monsanto Research Center, Bangalore, observed, "Science and Technology is Monsanto's core strength and competence. We have a world-class research center in Bangalore, which is doing cutting edge technology. Our research spreads in datamining (informatics and bioinformatics), gene characterization, plant transformation, and crop protection." For the R&D division doctorates and post doctorates with domain specialization and relevant experience are sought. "Whereas in the sales division there is intake of candidates with diverse qualifications like MBA, MSc Agri, Bcom and PhD. Our main focus is not on experience but on the potential of the candidates to deliver and do the job. We focus on a diverse profile," said Dipankar Bandyopadhyay, HR manager, Monsanto India. Companies like Indo-American Hybrid Seeds (IAHS) and Prabhat Agri Biotech have independent biotech divisions, which employs scientists and technical assistants. In most of the companies the size of the core work team ranges from about 35 to 100. Taking the entire workforce into consideration (research, technical support and marketing), the ratio of manpower to women power is 8:1. But if the research section is seen alone then the ratio can be as high as 1:1. The salaries depend on experience, skills, quality and availability and it varies between Rs 6,000 and 50,000 per month. In the near future, agri biotech will no longer be a discrete sector but will become an extension of the existing agricultural system and the industry will see a slow shift from chemical to gene-based solutions in agriculture. BioPharma Largest contributor to biotech industry With the focus shifting to R&D and manufacturing of biotech based drugs, it's good news for biotech professionals. With the product-patent regime in place, R&D in the biopharma has been identified as one of the key growth drivers. Today the biopharma sector is the single largest contributor to the Indian biotech industry. Many new biotech-based pharma companies have come up and restructuring is the current buzzword in the traditional pharma companies. For Indian pharma companies, the major advantage of entering this market is the relatively short timelines needed to develop a product, tap the vast human resource available and bring the product at an affordable rate in the market. In fact, in view of escalating R&D costs in their home countries, many MNCs have set up branches in the country to gain the cost and time advantage. Diagnostics, vaccines, and recombinant therapeutic proteins are the promising sectors of this industry. In 2004-05, the vaccine market accounted for the largest, about 47 percent share of the biopharma segment and therapeutics was the second largest contributor accounting for 20 percent of the total biopharma revenue. Diagnostics is still a nascent segment with companies like Bhat Biotech, Qualigens Diagnostics, Span Diagnostics, J Mitra & Co and XCyton Diagnostics bringing out innovative products. Who are needed? Dr SD Ravetkar, senior director, Serum Institute of India said, "The sector calls for professionals from various fields as biopharma is the cocktail of so many faculties-microbiology, biochemistry, molecular biology, immunology, chemistry, biotechnology and more. It requires candidates with diverse qualifications - microbiologists for the manufacturing process, biochemists for the down stream processing, immunologists for animal trials, biotech engineers for bulk manufacturing processes or process standardizing, etc." The field requires people trained in new technologies with specialized skills, like immunoblotting, protein/genome analysis, western blotting etc. And in today's scenario candidates possessing these skills are rare. The responsibility and specialization of the individual will depend on the process, which he/she is handling - fermentation technology, downstream processing, proteomics, genomics, etc. Dr BV Ravikumar, managing director, XCyton Diagnostics, believes there is a tremendous potential in the diagnostics sector too. He observed, "Cancer and lifestyle diseases are on an increase in developing world and developing nations. Cancer is the second leading cause of death in China. Spending on CVS and diabetes is three times the amount spent on all infections in India. Hence basic expertise in diagnosis, which includes biochemistry-blood glucose, urea, cholesterol, liver function tests etc., based on organic chemistry and enzymology; microbiology-detection of bacteria, fungi and parasites based on microbiological isolation and identification; immunodiagnostics-hormones, cardiac diagnosis, cancer detection, drugs of abuse and infection detection based on antigen-antibody interactions and immunology; and nucleic acid testing-cancer detection, infection based on molecular biology, will come into prominence. So the diagnostic industry requires human resources for production (cell biology), for biochemistry (chemical engineers), for quality control (microbiology; molecular biology, cell biology), and for marketing (Clinically trained personnel)." An aptitude for trouble shooting is the requirement. "Physicians have complicated requirements thus requiring application specialists," Dr Ravi Kumar added. A common advice by pharma majors to aspiring candidates is to hone their skills. As, ironically on one side, the sector has a requirement of a large number of people and on the other hand there is an acute dearth of adequately trained students. Most of them do have a strong theoretical background but do not possess enough practical skills. Students need to gain hands-on experience in the new upcoming branches of science. Now a minimum work experience of two to three years is gaining priority and provides a crucial selection edge. The salaries of researchers in pharma companies are appropriate, merit based and have begun to reflect the growing demand for skilled people. The growth potential for employees is good, as it is a nascent industry. Generally employees who perform well are sent for technology development training programs both in the country and abroad, like Serum Institute sends its employees to the US and UK for training in cGMP and production techniques. As developing new biotech-based solutions has become the main focus area for the pharma companies, the demand for the scientists is expected to continue to grow. BioInformatics A niche area Indian Bioinformatics industry has the potential to double its presence in the global market The Indian Bioinformatics market, which is only 2.5 percent of the global market, has the potential to capture 5 percent of the global pie, according to a recent report prepared by the Confederation of Indian Industry (CII) and Department of Information Technology (DIT). To capture 5 percent of the global market, the industry would need to grow at a CAGR of 42 percent. And in keeping with this trend, a majority of the Indian Bioinformatics companies are planning to increase their scale of operations in this area, mentioned the report. According to the study, the total annual manpower required by the industry to achieve a growth rate of 42 percent would be 6,484 professionals in 2008-09 and 26,362 professionals in 2012-13. And in addition to the national demand, there would be a demand for Indian Bioinformatics professionals from rest of the world, which is expected to rise from 348 in 2003-04 to a total of 8,169 by 2012-13. Presently, the industry attaches a lot of importance to the level of experience of a candidate and prefers experienced personnel to freshers. Though the opportunity exists, it should not be construed that bioinformatics is the next big thing. It is not and cannot be compared with the IT sector, say industry observers. Bioinformatics, the amalgamation of biology and information technology, requires a range of "interdisciplinary skills". "The requirement here is to be able to have a good blend of computer scientists and life scientists working together and delivering solutions, which are the best of both domains, " observed Anuradha Acharya, CEO, Ocimum Biosolutions. Bioinformatics companies generally have well-defined teams with a clear business focus. For instance, in Mascon there are three groups - a functional team that is the driving force of the organization and is built up of best of the domain experts. A development team that is the supporting bone of the organization consisting of software professionals. And a business development team which is the source of momentum of the organization carrying the domain experts with specific industry experience. Other companies like SysArris have domain experts who have expertise in genomics, cheminformatics and other areas. Besides the basic qualification (a masters or higher degree in a branch of life science or computer science), prior experience or training in the industry or research organization is an added advantage. But the experience required would depend on the openings from time to time. As such, bioinformatics being a new field, it is very difficult to get people who are cross-functional. Hence companies generally provide training before putting the candidate to work. The salary range depends on the experience and capabilities of the person and performers are recognized and well-rewarded. "While the starting salaries could be anywhere from Rs 10,000-20,000 depending on the experience of the candidate, it can go up very high as there is a review every six months," said Anuradha Acharya. This interdisciplinary field is a valuable tool to solve the problems encountered by life scientists while dealing with complex biological systems. It has tremendous potential and scope as it moves hand in hand with various disciplines of life sciences. BioServices An outsourcing hub Contract research manufacturing has evolved into a huge market. The CRO segment in India mainly consists of contract research, contract manufacturing and clinical trials. The Indian market has companies doing clinical research and trials for the molecules developed in-house (captive CRO) like Eli Lilly. And there are organizations doing contract research and trials for other companies (independent CRO) like Quintiles Spectral, SIRO Clinpharm and Syngene. Aurigene, Shantha Biotechnics and Chembiotech are some of the other important companies. Syngene International, a Biocon group company, set in 1994 was India's first integrated CRO in the area of drug discovery. It is presently serving over a dozen pharmaceutical units in Europe and the US. "Market trends indicate that the CRO market is going to experience rapid growth in the coming years and will become an indispensable part of the drug development process. The CRO industry is a major employer of medical and scientific staff and hence the demand for qualified personnel is on the increase. Various Opportunities in BioServices Courtesy: Dr Krathish Bopanna Dr Krathish Bopanna, Chief Technology Officer, Manipal Acunova, Bangalore, informed, "India is becoming a hot destination for clinical research. Clinical trials in India are growing at a 60 percent AAGR and crossed $100 million in 2004. By 2010, the industry will spend over $300 million on clinical trials in India. There are already 20 CROs like Quintiles and Manipal Acunova which offer Phase I to IV trials complying with ICH-GCP guidelines. With 80 hospitals serving as sites for clinical trials, India is emerging as one of the fastest recruiter of subjects across the world. So there are endless possibilities." With very rapid growth in number and size of companies, the spectrum of skills required is in scarcity. Bopanna added, "Lack of specialization, limited pool of experienced people, cross functional approach and new emerging platform technologies and convergence of disciplines are some of the reason why skilled training will be needed. Adaptability and flexibility are the key factors that drives this business opportunity." "In the contract industry, the people should be highly skilled and versatile to take up different projects and execute them at low cost in order to be competitive and effective," opined Raman Akella, head administration, Shantha Biotechnics, Hyderabad. In any CRO the job categories depend on the nature of the contract service undertaken. Scientists in the field of synthetic organic chemistry, molecular biology and bioinformatics are required at Biocon. Aurigene looks for screening pharmacologists, chemical researchers and experts in the field of genomics, computational biology and bioinformatics when the project is in the initial stages of drug discovery. A few job categories at Shantha Biotechnics are fermentation, purification/process analysts (technical), quality assurance, registration/documentation personnel (regulatory), plant and process, quality assurance, operations personnel (management) and medical advisors. Projected growth of the Indian clinical research industry Resources 2010 Clinical research market $1.5 Billion GCP Studies 1,500-2,000 GCP trained investigators 10,000-15,000 Subjects required 2,00,000-3,00,000 Clinical research professionals 50,000 Source: McKinsey Report "Clinical trial is a very data and quality intensive work and may involve high percentage of travel. The scope of any error is very limited and involves high degree of ethics both personal and professional," commented Rajiv Gulati, managing director and chairman, Eli Lilly and Company (India). In this segment growth prospects are excellent and are performance-related. The salaries are very attractive and much above the average salaries in the medical sector or pharma industry. BioSuppliers A growing market The sector is abound with opportunities for people from diverse backgrounds. This sector offers good career opportunity for graduates/post graduates with bio or chemical engineering background with a couple of years of experience in a lab or industry. Depending on whether the company is dealing in generic or high tech products, equipments, consumables, disposables, etc., the profile of required candidates may vary from company to company. As Dr P Babu, director, Bangalore Genei, aptly puts it, "BioSuppliers could be both trading companies and manufacturers. Further biosuppliers could be based on the nature of equipments/instruments or reagents, enzymes etc., so it is difficult to group all the biosuppliers together. The segment is more niche unlike biopharma/bioagri." If the company is primarily into manufacturing, like Alfa Laval, which is one of the leading manufacturers of engineering equipments and supplier of complete plants then the main job functions will be pre-engineering of the processes and products, preparing specifications and drawings, procurement and execution of projects with documentation. Accordingly, the company will look out for chemical/biotech engineers. Similarly if the core competency of the organization is making reagents, diagnostic kits, enzymes, etc., then it will require candidates possessing post graduation or doctorate degree in biochemistry, biotechnology, microbiology or related life science fields. And if the company is a distributor of biotech products, then it will require candidates having sound technical knowledge about the products along with strong sales and marketing background. Cambrex Chemicals, a 100 percent subsidiary of the US-based Cambrex Corp., assists the biotech industry in maintaining its product quality and also supplies ingredients used by the research institutions to develop new products. "The job categories are business managers, technical service managers, etc. We require graduates with a basic biological background and any additional qualifications would add value. The candidates should possess integrity, team-playing capability and the ability to work independently," said Vivek Varma, business managerâ€“biotherapeutics, Cambrex Chemicals. "At Genetix the job categories are business development executives, product specialist and customer care representatives," said Arun Prakash, CEO, Genetix. The company offers marketing and technical support to biotech and life sciences companies. "The qualifications required are MSc (for business development executives), PhD for product specialist (men/women), graduates with computer skills for customer care representatives (women)," he added. In Amersham Biosciences, now a part of GE Healthcare Systems, the different levels of jobs throughout the organization range from product specialists, area manager, product manager, sales manager, application specialists, service engineers and service managers. "We have defined key responsibilities and accountability for each position/functions. For example, a salesperson or product specialist would assist in product management, key account management and be responsible for organizing seminars and demonstrations for the customer. Good communication skills, teamwork, self-motivation, perseverance, technical skills and a positive attitude are a few things we look for in a candidate. Candidates with exposure to the western scientific arena are also welcomed," said senior managers of the company. In general, the companies require candidates with a MSc or PhD degree in bio-related fields like molecular biology, biochemistry, chemical engineering, etc. A couple of years of either sales experience in a similar company or a couple of years of research experience in a lab or industry helps since most of the companies are technology-intensive. Specialization in a particular area is a definite plus. In fact, the trend is towards higher educational qualification in addition to basic sales and marketing skills, as the companies believes in not just selling a product but in helping the customer complete his entire research process successfully using their respective products. Therefore, it is essential for the employee to have a scientific mind and a good rapport with the customer. The growth potential for employees is excellent. Plenty of opportunities are available for growth within India and abroad too. Rolly Dureha                 ]]> <![CDATA[Making a Successful Career]]> https://biospectrumindia.com/news/95/4665/making-a-successful-career.html https://biospectrumindia.com/news/95/4665/making-a-successful-career.html Wed, 14 Sep 2005 10:40:00 +0530 Making a Successful Career Making a Successful Career Dr MK Bhan, secretary, Department of Biotechnology, is a well-known pediatrics scientist. He was a professor of pediatrics and chief, Pediatric-Gastroenterology and Nutrition at AIIMS. His contributions in the development of various vaccines against diseases in children have been widely acknowledged. Similarly, take the case of Dr BV Ravikumar of XCyton Diagnostics. He has been a doctor. Dr Krishna Ella is a trained microbiologist, who is well versed in plant, human, and health systems. Varaprasad Reddy, the founder of Shantha Biotechnics, is an engineering graduate (Electronics & Communication) from Andhra University and an MBA from Osmania University in 1980, who worked in Defence Electronics Research Lab. Clearly, a study of the lives and successes of the top notch professionals in this industry show that it is not educational qualification alone, but their ability to look beyond what matters. There is no single formula for success. Focus, determination, and keeping abreast with the latest trends in the sector are the key tools. Neither it is a man versus woman race. On the contrary it is found that this sector, specially in the area of R&D that women account for as much as 30 percent of the workforce. There are at least 20 women in the top positions in the sector. Kiran Mazumdar-Shaw, chairman and managing director, Biocon, is an example of grit, confidence, and hands-on manager, who has turned Biocon as the country's leading biotech company. Other women who have made a tryst with this sector include Anuradha Acharya of Ocimum Biosolutions; Anuradha Desai of Venkateshwara Hatcheries; Dr Firoza Parikh, who was associated with Reliance Life Sciences; Dr Lila Poonawalla, former managing director, Alfa Laval; Dr Usha Barwale Zehr, joint director, research Mahyco; Dr Villoo-Morawalla Patell, managing director, Avesthagen; Kumud Sampath, president, Astra Zeneca; Lilly Sanathanan, president, ClinWorld; Dr Madhuri Sheron, managing director, Monad Nanotech; Mahima Datla, vice-president,, strategic business development, Biological E; Mala Vazirani, director marketing, Transasia; Medha Gadgil, managing director, Haffkine; Narges Mahaluxmivala, president, clinical development services, Quintiles India; Ranjana Smetacek, director, Monsanto Holding Ltd, India; Sangeeta Topiwala, head, planning and development, Roche; Suchitra Ella, founder-director, Bharat Biotech; Swati Piramal, director, strategic alliances and communications, Nicholas Piramal; Dr Rama Mukherjee, director, Dabur; Deepanwita, managing director, ICICI Knowledge Park; Radhika Choudary, executive director, ABLE; Dr Saral Thangam, medical advisor and vice president, Lotus Labs; Dr Vyjayanthi, chief clinical investigator, Lotus Labs; Dr Sandhya Ravi, head-clinical trials, Lotus Labs, Dr Anuradha Srikrishna, head-medical diagnostics division, Lotus Labs and Radha Shekar, chief technical officer, Lotus Labs. In the ensuing pages we bring to you a few examples of how people have carved out a biotech career for themselves. "Students must do their PhDs" Dr M K Bhan, secretary, Department of Biotechnology. A well-known pediatrics scientist, Dr MK Bhan, took over the reins of the Department of Biotchnology in March 2004. As the Secretary, DBT, he has been instrumental in developing the National Biotechnology Draft Strategy, which in its final shape will provide an impetus to the Indian biotech industry, fine-tune human resource development, synergize biotech research, facilitate industryâ€“academia partnership and encourage biotech trade. A great votary of quality biotech education, he strongly believes that the country needs scientific leaders. Commenting on the current status of trained human resources in the biotech arena, he said, "There is a misconception that the country is lacking in skilled and qualified manpower. This is not the right kind of thinking since practical exposure in the industry is required for any qualified person to become skilled. What we actually lack is scientific leadership. Without effective leadership, it is not possible to create successful enterprises." "Quality education is a must and those with the minds to excel will be in high demand. At this point of time the recruitment from campuses is low primarily because the industry is in a nascent stage and is maturing. Once this happens, scaling will be the issue for the companies," he added. In his message to the students, Dr Bhan said, "I would call upon you students to do PhDs. It will never be an issue to do them. DBT has several scholarships and those will be given to you." "Hard work mantra for success" Dr VK Vinayak, advisor - Biotechnology in the New Initiative (R&D) division, Panacea Biotec A distinguished scientist, Dr VK Vinayak is one of India's leading authorities in the area of medical biotechnology. With a rich experience of about 36 years in this field as a scientist and a key policy maker, he is presently the Advisor, Biotechnology in the New Initiative (R&D) division in Panacea Biotec, a leading Indian healthcare company. Always "Swimming against the current" has been his motto and coupled with hard work and a focused attitude have helped him achieve his goals. Dr Vinayak has been keenly following the current trends in the Indian biotech industry. He remarked, "Till now the percentage of good scientists opting for the industry was very small, only 15-18 percent. Budding biotechnologists should remember that the industry is now involved in innovative R&D and many of the private companies spend about 15-20 percent of their turnover in it." "Besides research, there are openings in companies at various levels like in quality control, marketing and sales, regulatory sector, technology transfer, etc. For a start-up, bioservices is an attractive option providing immense opportunities in areas like gene optimization, manufacturing process optimization, cell line characterizing among others", he added. Concerned about the quality of the human capital being generated in the biotech arena, he opined, "Though there is a large churn-out of biotech students in the country today, their overall quality is not good. Today most of the students are like technicians and there is a great dearth of talent. Only if one is innovative, wants to develop something for mankind, he/she should enter the biotechnology arena. The industry needs researchers with niche specializations, like medical biotechnology needs specialists in molecular virology, molecular immunology, molecular pharmacology, stem cells, molecular monoclonal antibodies, etc." Hard work, focused approach and clarity about what one wants to achieve in biotechnology are the final words of advice for students. "Prepare for growth through training and development efforts" Dr Chetan Tamhankar, general manager, SIRO Clinpharm, Mumbai Dr Chetan Tamhankar, with his doctoral program in Pharmaceutical Sciences with specialization in Bio-pharmaceutics and Pharmaco-kinetics from the University of Mumbai, is currently working as general manager at SIRO Clinpharm Pvt Ltd, one of the leading and the first few companies in India to initiative activities in clinical research in the country. Dr Tamhankar has been associated with the industry for over eight years at different levels. He has years of experience in clinical research management as a CRA and has worked as clinical project manager on several studies that were used for registration in Europe, Japan and India. He worked as manager- clinical quality assurance and has audited several protocols and investigator sites for their compliance with ICH GCP and Protocol. He was also responsible for the setting up of clinical data management and biometrics department at SIRO. He says, "There is a sort of boom in this industry. I believe there is and will be increasing need of trained manpower in clinical research over next decade. You will realize that clinical research management is purely skill-centric business and human capital will be the most important aspect of making India successful in clinical research." Dr Tamhankar is part of different academic and scientific committees including executive curriculum committee of the Academy of Clinical Excellence Mumbai, a premier teaching institute in clinical research methodology, scientific committee of Indian Society for Clinical Research, research advisory committee for University Board of Veterinary research and has been working as a research examiner for doctorate and post graduate programs in pharmaceutical sciences. He says, "There is tremendous opportunity in this field. But the industry will face scarcity of trained manpower in coming years. Students should look at these opportunities in clinical research positively and prepare themselves for the growth through training and development efforts." "Excel in one area" Rajeev Gangal, chief technology officer, itCube Pvt Ltd, Pune Rajeev Gangal who is presently working as chief technology officer for itCube Pvt Ltd, a wholly owned subsidiary of itCube Inc, an Ohio-based organization that develops customized solutions for process management of medical and clinical research, took up a career in bioinformatics. Having seven years of experience in this field at different levels and also in different companies such as AstraZeneca India as bioinformatics researcher, project leader at Forscience and consultation to Evolvus, start-up companies in bioinformatics and also as co-founder and chief scientific officer of SciNova Technologies Pvt Ltd, he observes, "Bioinformatics as a business is mainly the IT component. In the west, bioinformatics with more emphasis on life sciences has been around for quite some time due to the emergence of new technologies like micro arrays, proteomics, metabolomics. India has virtually no exposure to these technologies. Thus the bioinformatics opportunity is very limited in India. However, there is a significant amount of work being done in bioinformatics database curation. India has good talent in statistics, mathematics and physics. Life science combined with the above and computing will help us carve a niche in the area of Systems Biology. With the increasing availability of pathway and protein interaction data and clinical data, it will be a major thrust area, " Gangal says. Besides Dr Anand Kumar from AstraZeneca Research Foundation Bangalore, who is strongly committed to supporting novel ideas and technologies developed in India, he says Dr Milind Watve, Prof. Abasaheb, Garware College, Pune and Dr Shridhar Gadre from the Chemistry department of Pune University, have influenced him a lot in this information technology driven life sciences industry. Gangal has some tips for students who are looking at taking up courses in bioinformatics: learn the basics of how to standardize, interpret and analyze data, learn to bridge the gap between programming and life sciences, specialize in one of them and be good in the other. He says, "These skills will stand you in good stead." "Follow 3Cs for success" DG Tripathi, director, Tulip Group of Companies, Goa. With science background at the graduate level and a masters degree in Management Studies from the University of Bombay, DG Tripathi, director, Tulip Group of Companies, was initially involved in a pharmaceutical company before being introduced to invitro diagnostics industry. Sharing his experience of entering the diagnostic sector, he says, "I was initially involved with the pharmaceutical industry. Between 1982 and 1990, phenomenal changes took place with the introduction of monoclonal antibodies, recombinant technology as well as the discovery of the HIV virus which had a direct bearing on product development as well as creation of huge opportunity for delivery of advanced products to laboratory users. This fascinated me to opt and continue in biotechnology as a career option." Speaking about the growth of biotech industry in general and diagnostic sector in particular, Tripathi says, "The opportunity now and in the coming years in biotechnology is better than ever before. With accent on molecular biology and biosensors, the potential to develop new disease diagnosis platforms using the aforesaid technologies is tremendous. Through the development of proteomics and the completeness of the human genome project, new markers of disease are emerging at a fast pace. The challenge and excitement of utilizing these new markers in conjunction with new assay platforms will throw up opportunities for the industry to grow. " Tripathi has developed Goa-based Tulip Group of Companies which includes Tulip Diagnostics (P) Ltd, Orchid Biomedical Systems, Lilac Medicare (P) Ltd., Coral Clinical Systems, Qualpro Diagnostics, Zephyr Biomedicals into a Rs 100-crore company, taking care of the overall corporate management activities, sales, marketing and finance. He has a few tips for students. He says, "For success, follow 3Cs namely character, competence, and courage. Build and demonstrate these three Cs for continued success in life." Commenting on the his role model, Tripathi says, "It is difficult to find a perfect individual to emulate. I believe that one can learn and imbibe from strengths of every individual that one works with. I have continued to learn from almost all individuals whether they have been my superiors, colleagues or subordinates." "Lets contribute for better living" C L Rathi, managing director, Advanced Enzyme Technologies Ltd. A chemical engineer by qualification, CL Rathi, the promoter and managing director of Advanced Enzyme Technologies Ltd (formerly Advanced Biochemicals Ltd) -India's largest industrial enzyme manufacturer and ranked amongst the "Top 10" in the world - pursued his interest in horticulture way back in 1976 and took up papaya cultivation for a couple of years. It was during this time that he conceived the idea of application of horticultural harvest by producing enzymes. This strong urge led him to start his first venture, Rathi Papains Pvt Ltd in 1978. At that point of time the business was confined to manufacturing an enzyme called Papain only. The business was later expanded and Advanced Biochemicals Ltd. was incorporated in 1989 to cater to requirements of a wide range of enzymes in the various industries. Giving credit to his father who influenced him to look at a career in enzymes, Rathi says, "It was my father's dream to make India self-reliant in this very vital technology - enzyme technology. He was a freedom fighter and Gandhian throughout his life. I got my mission from my father - LC Rathi who started India's first enzyme company way back in 1958 called Enzochem Laboratories Pvt Ltd producing natural papaya based enzyme â€“ papain." With expertise in enzyme manufacturing for about 28 years, CL Rathi shared his thoughts on "White Biotechnology" at a two-day discussion conducted by DECHEMA (Society for Chemical Engineering and Biotechnology), a non-profit making scientific and technical society based in Frankfurt, Germany. "The next 2-4 decades will see rapid and tremendous growth in biotechnology. As we realize more and more, we shall need biotechnology for all our existence - food, clothing, shelter, etc. because only that way nature does the work.....!" A strong disciple of Sri Sri Ravi Shankar - the founder of Art Of Living Foundation, Rathi advises the younger generation to put 100 percent efforts in whatever they do. He says, "Life is joy and fun. Let us all enjoy life by contributing to better living through biotechnology." "Understand subject in depth" Dr Dhananjay Patankar â€“ head- biotechnology, Intas Pharmaceuticals Ltd A chemical engineer from IIT Bombay (BTech, 1986), Dr Dhananjay Patankar is currently heading the biotechnology division of Intas Pharmaceuticals Ltd, Ahmedabad, where he looks after the overall development of recombinant protein drugs. He has led the development and manufacturing of two products, which are currently in the market, and five others are at various stages of development. On the opportunities in biotechnology in the coming years, Dr Patankar who was an industry nominee on a National Task Force for Regulatory Reform in Recombinant Biopharmaceuticals in 2004, says, "I see a lot of growth happening in the biopharma field. A number of Indian companies are already well established in the field, with several having successfully developed and commercialized biotech drugs. These companies are now ready and looking for the next level of growth, to make a mark in the international arena. Apart from that, many new companies are also entering the field. It is fair to expect continuing growth in opportunities as well as salary levels." "What companies need is high quality of people. We look for students who have a thorough understanding of the subject, irrespective of the actual degree that they have," he adds. With a good academic and industrial background and industrial experience of over a decade, Dr Patankar suggests students community that it is important that whichever field they choose, they must aim to understand it in depth, understand the principles behind various things, and understand the cause and not just the effect. At the same time, from an industry point of view, it is necessary that the students should develop a good alround view of things, such as the economic implications of various technologies, knowledge of patent regime, etc. ]]> <![CDATA[Institute of Bioinformatics and Applied Biotechnology (IBAB)]]> https://biospectrumindia.com/news/95/5913/institute-of-bioinformatics-and-applied-biotechnology-ibab.html https://biospectrumindia.com/news/95/5913/institute-of-bioinformatics-and-applied-biotechnology-ibab.html Wed, 14 Sep 2005 10:16:00 +0530 Institute of Bioinformatics and Applied Biotechnology Institute of Bioinformatics and Applied Biotechnology (IBAB) The Institute of Bioinformatics and Applied Biotechnology (IBAB) is a joint venture of the Government of Karnataka and ICICI. Its mandate is to help grow the biotech industry. IBAB has attained high standards in bioinformatics and biotechnology education. The Institute has attained national and international visibility in a short span of three years. Its immediate objectives include: To conduct postgraduate courses in bioinformatics and biotechnology; To undertake short-term training programs for students or working professionals; To work with start-ups in the biotechnology industry; To carry out research in the field of bioinformatics and biotechnology. The postgraduate diploma course in bioinformatics was the first course launched by IBAB. Currently the fourth batch of students is enrolled. Students are selected based on an all-India entrance test conducted at six centers followed by an interview at Bangalore. A batch of 40 has students with diverse backgrounds such as engineering, medicine, pharma, agriculture, life science, physical, chemical and statistical sciences with good representation from each discipline. Apart from the core courses related to bioinformatics, students undergo training in areas like IPR in biotechnology, business and science, scientific writing etc. The diversity in the students' background has made group study a valuable tool. The course curriculum is designed to introduce the students to basic concepts in biology, computers, statistics, mathematics, chemistry which form the backbone of bioinformatics to train them in the latest tools and techniques in this area. The methodology IBAB has adopted to train a diverse class through in-house projects and 6-month internships has proven itself by the acceptance of IBAB graduates by industry. Today IBAB has a placement rate of 95 percent. The second course launched by IBAB is the laboratory course in biotechniques. There is increasing demand for reliable technical expertise in the area of molecular biology/biotechnology. Many post graduate courses are unable to provide adequate training in laboratory bio-techniques. This course aims to fill this gap. However, the course is more than just a series of experimental demonstrations and hands-on sessions and involves thorough familiarization with experimental planning, execution and hypothesis-testing. Apart from the two regular courses IBAB also conducts workshops and short term training programs. IBAB is also involved in promoting entrepreneurship in biotechnology and related areas. Two R&D companies are being incubated by IBAB. Microtest Innovations is in the area of disease diagnostics, and Cellworks Goup is working in the area of in-silico drug discovery. Additionally several groups of IBAB students are exploring ideas to start their own companies. Institute of Bioinformatics (IOB) The Institute of Bioinformatics (accessible at http://www.ibioinformatics.org) was set up in March 2002 as a center of excellence in the field of bioinformatics, without any support from the US or Indian governmental funding agencies. Located on the premises of the International Technology Park, Bangalore, IOB is now a research institute recognized by the Department of Scientific and Industrial Research (DSIR) as a scientific and industrial research organization. IOB is affiliated to two distinguished universities for the award of PhD degrees. Manipal Academy of Higher Education (MAHE) and Kuvempu University have agreed to accept students from IOB involved in research projects for their PhD degree and thus associate their universities with the growth of this rapidly evolving, multidisciplinary research institute. While IOB scientists are doing cutting edge research, the institute decided to reward them with a chance to do PhD. Under this scheme, IOB has facilitated eight people to register for PhD. Six students of this program are currently undergoing training in cutting-edge technologies such as mass spectrometry and microarray techniques at Johns Hopkins University in the laboratory of Dr Akhilesh Pandey, the founder and chief scientific advisor of IOB. Another student is slated to join his lab shortly. In addition, IOB undertakes regular training program for its scientists through lively interactive sessions on actual research problems. A number of scientists who have worked at IOB have subsequently joined PhD programs in the US, Europe and Australia. IOB has recently established an experimental laboratory on its premises. Research is currently going on in both proteomics and functional genomics, both in collaboration with Dr Pandey's laboratory. In the proteomics arena, experiments involve analysis of various cell lines to identify interactions present in lower organisms but not reported in humans, by yeast 2-hybrid analysis, co-immunoprecipitation and western blot experiments. Towards this end, IOB is now in the process of acquiring a tandem mass spectrometer to facilitate in-house high throughput proteomics. IOB anticipates that cell lines, blood samples and tissue samples from patients suffering from diabetes, cancer, malaria etc. will be used for DNA microarray experiments to characterize gene expression patterns and their regulation for diagnostic purposes. Indian Institute of Science (IISc) The Division of Biological Sciences at the Indian Institute of Science (IISc) is engaged in frontline research at the frontiers of modern biology. It has three major departments, four smaller centers and three facilities and has on its rolls over fifty faculty members and about 300 research scholars and postdoctoral fellows. The scientists in the division deal with almost all aspects of modern biology: molecular biology, structural biology, immunology, enzymology, reproductive and developmental biology, ecological and environmental studies and so on. The methods employed in these investigations include genetic engineering, immunological techniques, PCR, spectroscopy, X-ray crystallography, electron microscopy, bioinformatics and computer modeling. Ongoing research programs in the Department of Biochemistry include diverse areas in modern biology ranging from Molecular Genetics and Cell Biology (Chromosome Organization and Inheritance, DNA-Protein Interactions, Protein Biogenesis and Trafficking, Protein Degradation, Transcription, Lipid Biochemistry, Organization of Viruses etc.), Various aspects of Organismal Biology (Immunology, Reproductive Biology, Plant Development) to understanding and prevention of various diseases (Malaria, Rabies, Tuberculosis and Plant Viral diseases). The research activities in the department are supported by grants from various Government of India agencies like the DST, DBT, CSIR, DAE, ICMR and international agencies like The Wellcome Trust, UK. Several application-oriented, industry sponsored research projects are also going on at the department. Some of these research projects have also led to useful applications in agriculture and health science. A few national and international patents have also been filed. The department is well equipped to perform research in different areas of biology. The Centre for Ecological Sciences, a center of excellence at the division, focuses on research areas related to biological diversity, human ecology, ecodevelopment, climate change and tropical forests, social behavior. It has excellent facilities for theoretical as well as experimental research in plant, animal and human ecology. The division has a molecular biophysics unit (MBU) for research activities in the fields of structure, conformation and interaction of biomolecules. So far about 100 scientists have obtained their PhD degrees and the number of research publications exceeds 1000. The government plans to develop IISc into a world class institute and has earmarked Rs 100 crore for the same in the Union Budget 2004-05.   ]]> <![CDATA[Biotechnology Education in India]]> https://biospectrumindia.com/news/95/3985/biotechnology-education-in-india.html https://biospectrumindia.com/news/95/3985/biotechnology-education-in-india.html Wed, 14 Sep 2005 10:11:00 +0530 Biotechnology Education in India Biotechnology Education in India There is a tremendous potential in the super speciality areas for development of high-tech products and processes. S L Govindwar Director Department of Biotechnology Ministry of Science & Technology (Govt. of India) New Delhi The last decade belonged to in formation technology and biotechnology and will continue to be attractive in the coming years. This century, however, will be an era of super specializations and the century of advanced technologies and environment-friendly products and processes. Biotechnology has the potential to develop new value-added products, processes, techniques/tools in the area of agriculture, human and animal health and environment protection. Biotechnology is a relatively new subject which has a vast potential for unlocking new technological combinations. It can give the solutions to the problems related to the agricultural production, human and animal health and the development of eco-friendly products as well as industrial pollution control. Biotechnology is a knowledge-intensive field and has the potential to bring about specific manmade changes in DNA or genetic material in plants, animals and microorganisms leading to useful products and technologies. It has the potential to develop genetically modified plants, animals and microorganisms. The field of Biotechnology in the last decade has already made a significant impact in agricultural, industrial, pharmaceutical and medical sectors. For achieving these goals, trained human resource is required. This was visualized in 1982 by the then National Biotechnology Board (NBTB) and initiated an "Integrated Programme of Human Resource Development". The Department of Biotechnology was the first government body in the country to start Human Resource Development in Biotechnology program in a big way. It is known that unless the trained human resource in Biotechnology is available, no research and developmental programs/activities can be initiated for the development of new products/processes/techniques and tools. Accordingly, the Department of Biotechnology had initiated a number of schemes for HRD. These are: â€¢ Post-Graduate Teaching program (MSc, MTech, MV.Sc and PG diplomas) â€¢ DBT-JRF program â€¢ Post Doctoral Fellowship program â€¢ Short-term training program. â€¢ Biotechnology Industrial Training program â€¢ Biotechnology Overseas Associate ship program â€¢ Technician training program â€¢ Visiting scientist from abroad program â€¢ Scholarships and awards (a) National Bioscience Award for Career Development (b) National Woman Bioscientist Award (c ) Biotechnology Product, Process Development and Commercialization Award (d) Distinguished Biotechnologist Award Biology Scholarships â€¢ Seminars/symposia/conferences program â€¢ Biotechnology popularization program â€¢ Popular lecture series â€¢ Biotechnology publications in English, Hindi and other languages. â€¢ Biotechnology exhibitions â€¢ National Science Day celebration in Universities/R&D institutions. The HRD program of the Department of Biotechnology encompasses an intensive teaching and training of young students, training of scientists and technicians at various levels, research associateships to mid-career scientists, visiting scientist from advanced countries for exposing to newly developed techniques used in Biotechnology. Like Information Technology, Biotechnology is nowadays being considered as a potential subject area for the career development and hence some of the private colleges have also started post-graduate teaching courses in Biotechnology. Here I would like to mention that unless the proper teaching facilities and expert faculty are available, one should not go for the post-graduate teaching courses in Biotechnology. While planning 'HRD in Biotechnology' the newer areas like functional genomics/proteomics, cleaner technologies, gene therapy, bio-safety, industrial biotechnology, molecular and human genetics, rational drug designing, upstream and downstream processing for recombinant products, IPR and patenting in Biotechnology etc. may be considered on top priority. DBT has already covered general biotechnology, agricultural biotechnology, medical biotechnology, marine biotechnology, bioinformatics, Industrial biotechnology, Pharmaceutical biotechnology and biochemical engineering and Biotechnology subject areas for the human resource development at the PG level. Some of the gap areas like environmental biotechnology, industrial biotechnology, proteomics/genomics, molecular genetics etc. needs attention in the coming years to cater the need of industry sector. Name of the University/Institution Annual intake MSc General Biotechnology (2- year courses) Jawaharlal Nehru University, New Delhi 30 Madurai Kamaraj University, Madurai 25 MS University, Baroda 25 University of Pune, Pune 20 Banaras Hindu University, Varanasi 12 Indian Institute of Technology, Mumbai 16 Indian Instt. of Technology, Roorkee (formerly Roorkee University) 24 Aligarh Muslim University, Aligarh 14 Guru Nanak Dev University, Amritsar 10 Devi Ahilya Viswavidyalaya, Indore 10 University of Hyderabad, Hyderabad 10 Himachal Pradesh University, Shimla 12 University of Calicut, 12 Banasthali Vidyapeeth, Banasthali, (for girls only) 25 Tezpur University, Tezpur 12 Gulbarga University, Gulbarga. 10 Jammu University, Jammu 10 Gujarat University, Ahmedabad 10 Mysore University, Mysore 10 University of Allahabad, Allahabad 12 Guru Jambheshwar University, Hisar 14 University of Kashmir, Srinagar 10 Kumaun University, Nainital 10 University of North Bengal, Siliguri 10 Lucknow University, Lucknow 10 Utkal University, Bhubneshwar 10 Pondicherry University, Pondicherry 10 Sri Padmavathi Mahila Visvavidyalayam, Tirupati 10 Nagpur Univrsity, Nagpur 10 Visva-Bharathi, Shantiniketan 10 TM Bhagalpur University, Bhagalpur 10 M.Sc. Agricultural Biotechnology (2 years) Assam Agricultural University, Jorhat 10 Tamil Nadu Agricultural University, Coimbatore 15 GB Pant University of Agriculture and Technology,Pantnagar 20 Himachal Pradesh Krishi Vishvavidhalaya, Palampur 5 Indira Gandhi Agricultural Univ. Raipur 10 Marathwada Agricultural University, Parbhani 10 Orissa University of Agriculture & Technology, Bhubneshwar 10 University of Agricultural Sciences, Dharward 10 Kerala Agricultural University, Thrissur 10 M. V. Sc (Animal Biotechnology) (2 years) CCS Haryana Agricultural University, Hisar 10 Jawaharlal Nehru Krishi Vishwavidyalaya, Jabalpur 10 Master in Medical Biotechnology (2 years) All India Institute of Medical Sciences, New Delhi 10 MSc Marine Biotechnology (2 years) Goa University, Goa 20 Annamalai University, Parangipettai 10 MSc. Neurosciences (3/2 Years) Tata Institute of Fundamental Research, Mumbai 5 Jiwaji University, Gwalior 10 National Brain Research Center, Gurgaon 10 MSc. Industrial Biotechnology Sardar Patel University, Vallabh Vidyanagar 10 M.Tech Biochemical Engineering & Biotechnology (5 years integrated /4 semesters/2 years course) Indian Institute of Technology, Kharagpur 20 Indian Institute of Technology, New Delhi 10 Dual degree (5 year integrated as well as 4 semester courses) Anna University, Chennai 25 University Institute of Chemical Technology, Mumbai (formerly UDCT, Mumbai) (* Industry sponsored) 20+10* West Bengal University of Technology, Kolkata 15 Indian Institute of Technology, Kanpur 10 MTech. Pharmaceutical Biotechnology (2 years) National Institute of Pharmaceutical Education & Research ,Mohali 10 Post MD/MS Certificate Course in Medical Biotechnology (1 year) Sanjay Gandhi Post Graduate Institute of Medical Sciences, Lucknow 5 PG Diploma Course in â€œGenetic Engineering & Bioprocess Developmentâ€? after MSc (1 year) MS University of Baroda, Baroda 12 PGDiploma Course in â€œGenetic Engineering & Bioprocess Developmentâ€? after MSc (1 year) MS University of Baroda, Baroda shwara College, (University of Delhi), New Delhi 20 ]]> <![CDATA[The Biotech Centers of Excellence]]> https://biospectrumindia.com/news/95/6686/the-biotech-centers-of-excellence.html https://biospectrumindia.com/news/95/6686/the-biotech-centers-of-excellence.html Wed, 14 Sep 2005 09:59:00 +0530 The Biotech Centers of Excellence The Biotech Centers of Excellence The Department of Biotechnology (DBT) has been instrumental in giving a fresh impetus to the development of modern biology and biotechnology in India. DBT has been identifying and setting up Centers of Excellence for R&D and promoting large-scale use of biotechnology. It has set up seven autonomous institutes in frontier areas of modern biology, which not only facilitate focused research but also offer appropriate avenues for skilled, domain specific researchers in India and those coming from abroad. These institutes have played a big role in attracting Indian researchers working in foreign destinations. For instance, at the National Brain Research Centre, nearly 60 percent of the faculty comprises scientists who have returned from abroad. All the centers of excellence also play an important role in imparting specialized training to students and scientists. Most of the institutes have a doctorate program imparting wide exposure and experience to students in the select areas of neurology, plant genomics, immunology, cell science, etc. These Centers of Excellence are: Centre for DNA Fingerprinting and Diagnostics, Hyderabad Institute of Bioresources and Sustainable Development, Imphal Institute of Life Sciences, Bhubaneswar National Brain Research Centre, Manesar National Centre for Cell Science, Pune National Centre for Plant Genome Research, New Delhi National Institute of Immunology, New Delhi Centre for DNA Fingerprinting and Diagnostics The Centre for DNA Fingerprinting and Diagnostics (CDFD) has been providing services for DNA fingerprinting, diagnostics and bioinformatics in addition to basic research in frontier areas of modern biology such as genetics, molecular and cell biology, molecular pathogenesis and bioinformatics. It provides DNA fingerprinting services to various government and law enforcement agencies. In the diagnostics area, CDFD has broadened the range of services provided, encompassing cytogenetic, biochemical, molecular diagnosis and molecular cytogenetics. The institute has been designated as the Indian node for the European Molecular Biology Network and it also hosts an unusually large number of software and databases on its website. It has been imparting training in DNA fingerprinting. An active summer training and project training program attracts and enables young scholars to take up the PhD program at different institutes in the country. The students enrolled at CDFD register for their PhD degrees at the University of Hyderabad. The research areas being pursued in the frontier area of modern biology include genetics, epidemiology and diagnostics of childhood blindness; cancer biology and metastasis of HPV induced cervical cancer; structural and functional genomics of Mycobacterium tuberculosis; silkworm genome sequencing partnership at the global level; sequencing of the Mycobacterium W; computational biology, etc. Sun Microsystems Inc. has identified the CDFD as a vital center of excellence in the field of bioinformatics. It has joined hands with the CDFD consortium comprising the CDFD and the Government of Andhra Pradesh to set up the Center of Excellence at Gandipet, Hyderabad. The main focus of this center would be striving for excellence in the field of "Medical Bioinformatics". Institute of Bioresources and Sustainable Development The focus of this institute is bioresource development and their sustainable use through biotechnological interventions for the socio-economic growth of the North Eastern region. The institute operates with three scientific divisions, viz, bioresources database unit, medicinal plants and horticultural resources division and microbial resources division. It has developed a model-digitized database of bioresources with more than 3000 species record of flora and fauna of the North-East region. It has established in vitro cultures in various Zingiberales and has characterized the microbial resources associated with traditional fermented foods of Manipur. The institute has also carried out surveys for collection of phosphate solubilising microorganisms and cyanobacterial flora from the rice growing areas of Manipur as well as Loktak lake and other freshwater reservoirs. It is also active in training young researchers.   Institute of Life Sciences The institute conducts basic and applied research in the frontier areas of life sciences. Molecular biology of aging and cancer, infectious diseases including malaria, filariasis, cholera; biorsource development and ulitization including molecular aspects to stress adaptation, plant microbe interaction and microbial prospecting, plant molecular biology and functional genomics; and environmental biotechnology are some of the important research areas for the institute. It gives advice to various agencies on the application of the new findings and disseminates scientific knowledge. Affiliated to the Utkal University, Bhubaneswar and Sambalpur Univeristy, Sambalpur, for PhD degree, the institute has a doctorate program in various areas of life sciences. It also provides advance training to post MSc students. National Brain Research Centre The National Brain Research Centre (NBRC), established in 1999 as an "Apex Coordination Centre" for neuroscience research, has the mandate to create state-of-art facilities in the country through a networking approach and generate highly trained human resource. Major areas identified for research include computational neuroscience, system and cognitive neuroscience, stem cell research, developmental neurobiology and basic research towards understanding of neurological and psychiatric disorders. Currently a functional magnetic resonance imaging facility for neuroscience research is being developed at NBRC. As a deemed university, NBRC offers a PhD program and has initiated a MSc degree program in neuroscience. The center is networked with 44 neuroscience groups/institutions in the country to promote multidisciplinary research and provides the facility of a digital library, which it shares throughout the nation. At NBRC the research focus has been on identification of components of mitochondrial electron transport chain, which are specifically affected and interplay between protein thiol homeostasis and mitochondrial dysfunction. In stem cell research, the function of different types of proneural and neural differentiation genes is being studied using embryonic stem cells as a model system for studying neuronal differentiation. A novel computational approach has been initiated to study acoustic features of human speech by setting up the modulation spectrum. Several research projects have been awarded to scientists from international and national agencies at the Centre. The scientists at the institute have bagged many research grants including two from the Welcome Trust UK, two from the National Institute of Health, US, one each from the FIRCA, US, RIKEN Brain Research Institute, Japan, the US-India Fund for Cultural, Educational and Scientific Cooperation and the Third World Academy of Sciences. The institute has long-term collaborations with the national institute of Mental health, USA and Pavlov Institute of Russia. National Centre for Cell Science The National Centre of Cell Science is involved in research in the areas of cell biology, cancer biology, immunology, diabetes, signal transduction, and gene regulation. The center serves as a National Cell Repository for cell lines and hybridomas and supplied 1017 cell lines to 163 scientific institutes in India during 2004. The efforts towards establishment and characterization of cell lines resulted in establishment and characterization of new immortalized and primary cell lines with unique features. Some of the significant R&D achievements at the institute include identification of signaling pathways for controlling the mobility and invasiveness of breast cancer cells, role of IL-3 and Granultocyte towards blocking TNFa induced osteoclast differentiation. During the last few years, the NCCS has drawn special attention towards stem cell research in India. In the stem cell biology area, it has generated stable embryonic cell clones, which have the potential for neural cell lineage. Some other major findings at the institute include identifying a novel bacterial strain from the mosquito gut, which seems to have a role in host-parasite interaction; identifying a novel immune evasion strategy for defining drug targets in leishmaniasis; role of whole bone marrow in correcting hyperglycemia in diabetic mice; demonstration of strong anti-HIV activity in a fraction emanating from marine bivalve; understanding the potential mechanism of tat mediated modulation of cellular genes in HIV biology; among others. During the year, NCCS has published 35 scientific papers in international journals, obtained two US patents and filed six patent applications. The institute has tie-ups with many global organizations such as Pasteur Institute, Paris, France Medical Research Laboratory, University of Hull, UK, London School of Hygiene and Tropical Medicine to carry out research works. National Institute of Immunology The National Institute of Immunology (NII) has made intensive commitments to basic research in areas of modern biology related to the immune system. A wide range of issues have been addressed imaginatively and successfully by the scientists resulting in high impact publications in prestigious journals. Major areas of commitment-immunity and infection, reproduction and development, molecular design and gene regulation, - are well-placed to provide unity in diversity by their synergism in the broader cause of health and disease. The institute during its formative years was a recipient of UNDP grants to develop immuno-diagnostic kits relevant to tropical climates. This led to the development of diagnostic kits for detection of pregnancy, typhoid, hepatitis B and amoebiasis. The institute has developed, validated, and transferred the technology of two pregnancy kits, typhoid, hepatitis B, amoebic liver abscess and intestinal amoebiasis kits to the industry. The institute has developed a repository of high quality immunological reagents, restriction enzymes and plasmids. The institute is a collaborating center for the national mission project on cattle herd improvement through embryo transfer techniques. Seventy-eight papers by the scientists and scholars of the institute have been published/accepted for publication during the year. And the institute has filed three patents in India and one in PCT. Every year a large number of trainees, including both young students and scientists with specific training needs visit the institute for various periods. NII offers a PhD program, which draws nearly twenty students through a nation-wide entrance process. National Centre for Plant Genome Research The National Centre for Plant Genome Research aims at nutritional, structural, and functional genomics of various plant systems with the ultimate goal to manipulate plant genes to breed improved varieties of crop plants. The Center is currently engaged in plant genomic research with focus on structural and functional genomics for crops like chickpea, catharanthus, potato, tomato, lathyrus, rice, sweet potato, and cassava. The studies on chickpea are being pursued with overall objective to develop transgenics resistant to diseases, pest and drought conditions, while the Catharanthus studies are directed mainly to develop and use markers for construction of lines that hyper-accumulate commercially important alkaloids. The center has developed nutritionally enriched potato lines developed by transfer of Ama 1 gene of Amaranthus hypochondriacus into elite cultivars of potato accumulate proteins in large amounts (30-60 percent increase) with considerable increase in the amount of essential amino acids in transgenic tubers. To remediate oxalate toxicity in vegetables and grain crops, transgenic tomato has been developed using OXDC gene, which have very low content of oxalate and are tolerant to fungal infection. Both these crops are under field trials. A high artemisinin content and high leaf yielding variety of Artemisia annua cv Jeevanraksha-2 has been developed and the technology has been transferred for commercialization. A considerable amount of progress has been made in cloning and characterizing U-mannosidase gene from capsicum and tomato. The center is making significant contribution towards scientific manpower development in the advanced areas of plant molecular biology, genomics, and genetic transformation and around 25 students are presently registered for their pre and postdoctoral training.       ]]> <![CDATA[Online forum for clinical research specialists launched]]> https://biospectrumindia.com/news/95/1482/online-forum-for-clinical-research-specialists-launched.html https://biospectrumindia.com/news/95/1482/online-forum-for-clinical-research-specialists-launched.html Thu, 08 Sep 2005 10:52:00 +0530 Online forum for clinical research specialists launched Online forum for clinical research specialists launched The Indian Society For Clinical Research (ISCR) has been launched in India. This is the only broad-based association of its kind where clinical research professionals across India can network and contribute to the development of the industry. The ISCR will create a repository of information on clinical research in India that will be available on the Internet. ISCR will also monitor legislative and regulatory developments and make representations to the government and other agencies on behalf of the clinical research community. Through the Society, patients and patient support groups can interact with clinical research experts. In addition, new entrants in the field will now have greater access to expert training. Dr Shoibal Mukherjee, president, ISCR, said, "The rising trend of clinical research activities in the country will allow patients early access to potentially life-saving therapies. The government is playing its part in moving towards a regulatory atmosphere that is conducive to research of the highest ethical and quality standards. Evolving guidelines and increasing numbers of patients, sponsors, CROs, SMOs and investigator sites participating in clinical development, make it vital for a society such as ISCR to unify efforts and bring all stakeholders together."   Madras varsity to offer course on Immunotechnology The University of Madras has signed an MoU with Chennai-based Mediclone Biotech Pvt Ltd, to launch a two-semester PG Diploma program in immunotechnology. The course would enable post graduate students in life sciences to acquire basic knowledge in immunotechnology. A Mathiyalagan, managing director, Mediclone Biotech Pvt Ltd, said, "The specialized course on immunotechnology would provide training in theory and practice." The course would focus on the diagnostic and therapeutic tools derived from immunology, namely, monoclonal antibodies and their derivatives, natural and recombinant vaccines, gene and cell therapy. Further, the course provides a broad view of the subject covering recent developments in both basic and applied research in the field of innovative biotechnology. The University of Madras would conduct the course for a batch of 10 and Mediclone Biotech, which would also share their knowledge and experience, would absorb the professionals of the next three batches, over the next three years. CyberMedia New Cadila to invest Rs 40 crore in European biotech company Pharma major Cadila Healthcare Ltd has said that it will invest Rs 40 crore to acquire stake in a Europe-based biotech company. The board of directors at a meeting held on Aug 27,2005 approved in principle an investment in equity of up to Rs 40 crore in a European biotech company. The decision is subject to satisfactory due diligence to be carried out by the company. Polyclone ties up with Australia's Emphron Polyclone Bioservices, a Bangalore-based biotech start-up, has tied up with Emphron, an Australian boutique bioservices and microarray consulting major, for joint consulting in data analysis, data mining and experimental design for proteomics and genomics. "Our objective is to cater to high-density array analysis and production of high content low-density arrays, which is further upstream of whole genome analysis," said Naveen Kulkarni, CEO, Polyclone. This tie-up will establish a synergy between Emphron's data analysis capabilities with Polyclone's microarray core facility being set up at the University of Agricultural Sciences in Dharwad. "The focus is on developing novel arrays and also providing all the tools to the researcher to maximize the benefit of our products," he said. Kulkarni added, "This development ensures we can offer a whole gamut of services to the biotechnology industry, especially in the pursuit of high throughput, parallel experimentation and miniaturization." Emphron was founded by renowned biotech statistician Dr Mervyn Thomas in 2003.   Ranbaxy opens new R&D facility Ranbaxy Laboratories Ltd (RLL) opened its third state-of-the-art drug discovery research centre, at Gurgaon. The research facility was formally inaugurated by the President Dr APJ Abdul Kalam. Dr Brian Tempest, CEO & Managing Director, RLL, said, "We believe that R&D is one of our key competitive strengths and the addition of this facility further enhances our capabilities in the area of drug discovery and development systems." The new R&D centre is housed in a brand new building in the same campus as Ranbaxy's earlier research facilities. The new R&D center will focus on new drug discovery and the development functions of medicinal chemistry, analytical development, pharmacology, molecular technologies, infectious diseases, metabolism and pharmacokinetics. Suven Life Sciences embarks upon new DDDSS model Suven Life Sciences Limited, a pioneer in CRAMS, in its endeavour to become a collaborative research partner for global life sciences companies has embarked on a new business model DDDSS (Drug Discovery and Development Support Services) in January 2005. Launch of this business model coincided with Intellectual Property regime in India. Within a short span of 8 months, Suven could attract the second business opportunity in drug development segment of DDDSS, a Phase II clinical trial with data submission to US-FDA for an oncology product of a US company. Suven is currently in negotiations with three more US customers for new business opportunities in Phase II & Phase III clinical trials.   Glenmark's drug receives US FDA approval for more clinical trials Glenmark Pharmaceuticals S.A, a wholly owned subsidiary of Glenmark Pharmaceuticals Ltd, announced that the group's lead PDE-4 inhibitor GRC 3886 has received US Food and Drug Administration (FDA) approval to proceed further in clinical testing within the United States. The molecule has also been granted its International Non-proprietary Name (INN) "Oglemilast" by a WHO body, based on an expert advisory panel's recommendations. Oglemilast (GRC 3886), Glenmark's novel, oral, long-acting PDE4 inhibitor being tested for the indications of Asthma and COPD, had successfully completed Phase I single and multiple dosing stud ies in the UK in March 2005. Forest Laboratories, Glenmark's development and marketing partner for the drug in the territory of North America, had submitted an Investigational New Drug (IND) filing early this year to the FDA. The filing incorporated both pre clinical data as well as safety data in human volunteers generated during the Phase I trials. The FDA has now approved the IND filing thereby allowing Oglemilast to be evaluated in further clinical trials in human volunteers. As indicated earlier, the drug is on course to enter Phase II clinical trials by early 2006 in the US. Glenn Saldanha, managing director and CEO, Glenmark Pharmaceuticals said, "The clinical development of GRC 3886 is on schedule, spurred by this recent approval of Forest's IND filing by the US FDA. We are very excited by the performance of this molecule in Phase I trials and the recent IND approval and are working with our collaboration partners on accelerating the development program for the molecule." ]]> <![CDATA[UK Biotech Education High on Research and Training]]> https://biospectrumindia.com/news/95/2200/uk-biotech-education-high-on-research-and-training.html https://biospectrumindia.com/news/95/2200/uk-biotech-education-high-on-research-and-training.html Thu, 08 Sep 2005 10:01:00 +0530 UK Biotech Education High on Research and Training UK Biotech Education High on Research and Training The United Kingdom has long been an attractive destination for overseas students. One in eight students pursuing their higher education in the UK is from a foreign country. Currently, there are about 16,000 Indian students pursuing various undergraduate and post-graduate programs in the UK. Most of these students have enrolled for specialized programs including biotechnology. A qualification from a UK institution is very prestigious as standards are high at all levels. The universities and colleges are constantly assessed by official bodies that grade the standard of their research and teaching. The qualifications that the students gain are recognized worldwide and the UK courses encourage independence, creativity and self-reliance. At present there are over 50 universities offering a range of courses in biotechnology and related specializations, both at the undergraduate and postgraduate level, in the UK. The University of Cambridge, Oxford University, University of Essax, Imperial College London, Lancaster University, University of Sheffield, University of Abertay Dundee, and Leeds University are a few prominent institutes imparting biotechnology education. Many of the UK universities/institutes have been at the forefront of some exciting biosciences since the last 50 years. The discovery of the structure of DNA at Cambridge in 1953; birth of Dolly the sheep, the first mammal cloned from an adult cell at Roslin Institute, Scotland in 1997; the crucial contributions of the UK research institutes to the human genome project which led to its completion in 2003, are some of the important milestones marking the progress of the UK in the biosciences arena. Imbibing biotechnology education in the hub of such activity indeed has its own advantages. Essentially, biotechnology is an interdisciplinary field to train students in the application of modern technology, quantitative engineering methods, and principles of mathematics, chemistry and physics to the concepts of biology and medicine. Programs in the UK universities offer a range of focuses and often promote collaborative research across several departments within the university. The study courses are highly structured and focused with a lot of inbuilt flexibility. There are options of switching between related courses after the first year during under graduation and pursuing either a 3-year honors course or a four-year "sandwich" program. The sandwich program with a year of industry experience or overseas education helps in kickstarting a student's career even before the completion of the degree. The postgraduate courses are a one-year period of intense training either through taught or research option. The courses are structured as independent discrete study modules thus providing an exit route with a relevant certification during the course. A very unique feature of the UK universities is the strong industry-academia linkage in the area of biotechnology. There is a large spinout of companies from the universities of the UK with Cambridge and Oxford leading the trend. At present there are about eight spinout companies from the University of Oxford in a year. There were about 70 spinouts between 1994-1999 while during 1999-2000 alone there were 199 spinouts from the various universities speaking about the strong entrepreneurial ethos prevalent in the UK. Overall, currently there are about 480 companies in the biotech arena, employing about 23,000 people in the UK. This vibrant and thriving biotech industry offers enough avenues for employment to skilled students on completion of their education. Understanding that arranging finances could be an area of concern for international students, the UK institutions offer thousands of scholarships and bursaries for them and more than 21, 000 international students receive scholarship funding from the UK Government every year. The government has also made provisions under the existing work regulations for international students in the UK to work up to 20 hours a week when studying and full time during vacations. Finally, interaction with international peers, exposure to the UK biotech industry, gaining insights into its work culture; and most importantly getting access to global biotech networks in addition to a world-class degree, are the important attractions of studying in the UK. NOTE: A detailed overview of the course structure, relative advantages, new course programs both at the undergraduate and postgraduate level with some illustrative examples are given in the subsequent pages of this section. It should be noted that the examples are only indicative in nature and there are many such programs available across the country. Biotech Education with Industry Exposure The undergraduate courses in biotechnology and related subjects in the United Kingdom are a recent trend. Many of these courses started about three to five years ago and were developed as a comprehensive module suiting the requirements of the industry. There is a broad selection of biotechnology and related courses available at the undergraduate level with many options depending on the strength of the universities and other departments that can support developing new programs. There are undergraduate honors degree programs in biological sciences, biochemistry, human biology, bioinformatics, biotechnology and other related disciplines. The general aim of the undergraduate course is to equip the graduates to pursue higher degrees focused on research or more vocational courses like a masters degree. Why a UG degree in the UK? Apart from the obvious advantages of a world-class international exposure of the biotech industry, many universities under the UK educational system offer a unique opportunity to gain first hand experience by working with a biosciences company. Most of the universities have extensive links with companies and organizations in diverse fields from the pharmaceutical industry to medical research. For example, the University of Berminghan, which offers undergraduate degree programs in Biological Sciences, Biochemistry, Human Biology and Bioinformatics, has tie-ups with companies like GlaxoSmithKline, AstraZeneca, Celltech, Cambridge Antibody Technology, Novartis among others for the one-year professional placement of students. A year in the industry enables students to place the theoretical aspects of their subject into a professional context and increases their employment prospects on graduation. Another big advantage is the flexibility offered by the courses. This is the keyword while designing the study programs; all of which are modular with a wide range of options in the latter stages of the degree. The first year is generally an introduction to a whole range of subjects. This provides a firm base to build on in the second and third years, while also providing an option for students to choose a different degree scheme within the institute, should they wish, at the end of the first year. During the second and third years, the students combine various subjects based on what interest they have to make up the final degree. The course program is structured in such a way that it allows the student to delay the ultimate choice of specialization until the second year and to switch between related areas if the interests change. Course structure Typically, most of the universities provide an option of choosing from a three-year BSc honors course or a four-year BSc honors course. The four-year course is also known as a "Sandwich" course, with a year of study overseas or industry experience. In such a scenario, the student will have a chance to either transfer to work within industry or study at another foreign university for a year typically the US/Germany/Australia/ Singapore/Sweden depending on mutual agreements signed by the universities. The study transfer is done in the second year whereas the work experience is mostly carried out in the third year of study. Transfer credits for courses are accepted to the 'mother' campus of the student. For instance, the University of Wales, Aberystwyth offers a BSc degree in Genetics and Biochemistry. As part of this course, a student may spend one or two semesters at a university in France, Germany, Spain or Portugal as part of the European Union Socrates student exchange program. The University also has a well-established exchange program with Universities in the USA. Between years two and three, there is an opportunity to take a year's work experience through the "Year in Employment Scheme", which helps a student to test out possible future careers, learn new skills, carry out work towards the honors project and improve the career prospects. Similarly the Liverpool John Moores University offers a BSc degree in biotechnology via the "sandwich" route. The students spend the third year on a professional training placement. Current students of the Liverpool University are placed in laboratories in hospitals, research institutes and pharmaceutical/biotechnology companies both in the UK and abroad. A professional training tutor aids the students in finding a suitable placement, a process that usually starts at the beginning of the second year. The BSc biotechnology degree program of the University of Nottingham allows for a period of study/training at a European University, a placement through Universitas 21, or a practical year between years two and three. The Universitas 21 or U21 as it is popularly known is a global alliance of key universities. The Nottingham University recently introduced exchanges in which undergraduates spend one semester with its partners and the marks obtained count towards their degree. Examples of its current partners are Australia (Melbourne, Sydney, Brisbane), New Zealand (Auckland), Canada (McGill, British Columbia), USA (Virginia), Singapore, and China (Fudan, Hong Kong). The University of Reading also offers a four-year sandwich course in biotechnology with a two six-month placements in industry as a core component. Course curriculum The course duration is three or four years and the academic session starts from September/October. The study programs enable the student to acquire a firm grounding in biotechnology and to specialize in several aspects of the subject. The degree aims to apply recent developments in molecular and cell biology to a wide range of industrially important problems. Particular emphasis is placed on recent advances happening in this area. UK Trade & Investment can help you achieve your international business potential. UK Trade & Investment is the UK Government organisation that supports overseas enterprises seeking to locate in the UK as well as those seeking to work with UK companies in India. If you are looking for a joint venture or a technical collaborator, UK Trade & Investment can provide you with the contact details of potential UK partners. If you would like to meet visiting businesses or delegations, UK Trade & Investment can inform you of visits to a particular region of your field of interest. For further information, email: comenq.newdelhi@fco.gov.uk A general course outline for a BSc honors course will consist of study of general modules in fundamental biology and related disciplines like Chemistry, Biochemistry, Physiology, Microbiology and Cell Biology. Along with these, sometimes the students have to select a number of electives based on their interests and future career plans. During the second year, the foundations that were laid down previously are built upon and additionally the student is exposed to more specific modern biological and biotechnological subjects, eg. Cell Culture, Immunology, Analytical Chemistry, Food Microbiology, Structure of Biological Macromolecules and Medical Biochemistry among others. In the final year, the student can choose the direction in which he/she wishes to proceed e.g. Environmental Biotechnology, Molecular Biotechnology, Protein Science, Animal and Plant Cell Technology. Generally the honors students undertake an independent research project in their final year. Some universities also offer an undergraduate course in the related area of Bioinformatics. The course provides integrated training in all aspects of biological and computer sciences that are needed in this new area. Students take modules in core biosciences areas such as Molecules of Life; Molecular Cell Biology; Genes, Genomes and Heredity; and Evolution and Biodiversity, while at the same time learning fundamental computing skills such as working in UNIX environments, use of CGI and writing PERL scripts, programming in C and Java, and database, design, construction and maintenance. The course programs emphasizes on direct hands-on experience, using bioinformatics tools and learning about and understanding how to access and interpret the huge amount of data currently accumulating online. There are both three and four-year degree courses with professional placement in bioinformatics. The University of Birmingham was one of the first in the UK to offer an undergraduate degree in Bioinformatics which provides the students an option of spending a year either externally in a company or an institution to gain work experience, or doing an intercalated year in computer science, refining and developing their programming expertise. Career prospects This kind of undergraduate scheme of study offers employment avenues in the growth areas of biomedicine, forensic science, DNA profiling (humans, animals, plants), clinical cytogenetics and genetic counseling, biotechnology and food production, and aspects of biodiversity and the conservation of genetic resources and endangered species. The broad-based knowledge of modern biology also equips a student for a higher degree, postgraduate course or a career in medical, public health or forensic science laboratories and in the pharmaceutical industry. Many graduates passing out from the UK universities find work as professional scientists and managers in the biotechnology industry and as technical personnel in the biosciences companies. The wide range of options in the course program opens up job opportunities in the environmental, food, biomedical, pharmaceutical and agrochemical sectors. Gaining entry at UG level Most UK institutions accept the Indian school leaving qualifications (especially from the two main national boards: The Central Board of Secondary Education and the Council for the Indian School Certificate Examinations) for admission to undergraduate courses. The state boards are considered on a case-to-case basis. Applicants have to meet the minimum marks requirements and this varies from institution to institution. Competitive institutions generally expect a much higher percentage of marks. The institutions also consider other factors such as extra-curricular activities, relevant part-time work experience and the quality of the application. The personal statement and the reference from the principal/teacher are also very crucial. The Universities and Colleges Admission Service (UCAS) co-ordinates applications for undergraduate courses in the UK which means that a student only needs to fill up one UCAS application form and can apply to a maximum of six courses. The student needs to send the completed form to apply online through 'International Apply'. UCAS will forward it to the institutions concerned. There is an option of applying online through 'International Apply' too. The deadline for UCAS application to University of Oxford and Cambridge is October 15, and for other applications is January 15. All applications received after June 30 are put into clearing. Another important criterion for study in the UK is that all students need to show that they have an adequate knowledge of written and spoken English. In the case of international students, this usually means taking either an IELTS or TOEFL test. Rolly Dureha ]]> <![CDATA[Approved recombinant drugs in the world]]> https://biospectrumindia.com/news/95/2786/approved-recombinant-drugs-in-the-world.html https://biospectrumindia.com/news/95/2786/approved-recombinant-drugs-in-the-world.html Tue, 06 Sep 2005 17:15:00 +0530 Actimmune Approved recombinant drugs in the world  Product  Company  FDA Approval Date Actimmune® (interferon gamma-1b) InterMune Pharmaceuticals, Inc. Dec 1990,Feb 2000 Activase®/Cathflo® Activase® Genentech, Inc.  Nov 1987, Jun 1990,Jun1996, (alteplase; tissue plasminogen activator)   Sep-01 Advate(Recombinant antihemophilic factor Baxter Healthcare Corp. Jul-03 produced without any added human or     animal plasma proteins and albumin)     Aldurazyme® BioMarin Pharmaceuticals Apr-03 (Laronidase; recombinant enzyme replacement) Inc. and Genzyme   Alferon N® Interferon Sciences, Inc Oct-89 (interferon alfa-N3, human leukocyte derived)     Alphanate® Alpha Therapeutic Corp. Feb-97 (human antihemophilic factor)     Amevive® Biogen Idec Jan-03 (Alefacept; recombinant, dimeric fusion     protein; targets CD45RO+ T-cells)     Avonex® Biogen Idec May 1996, Feb 2003 (Interferon beta-1a; recombinant)     BeneFixâ„¢ (coagulation factor IX) Wyeth Feb-97 Betaseron® (Interferon beta-1b) Berlex Laboratories and Chiron Corporation Aug 1993, Mar 2003 Bioclateâ„¢ (antihemophilic factor) Aventis Behring Dec-93 BioTropinâ„¢ (human growth hormone) Biotech General May-95 Cerezyme® (imiglucerase; recombinant Genzyme May-94 form of beta-glucocerebrosidase)     Comvaxâ„¢ (Haemophilus B conjugate Merck & Co., Inc. Oct-96 [meningococcal conjugate]     and hepatitis B [recombinant] vaccine)     ENBREL® (Etanercept; recombinant Amgen and Wyeth Nov 1998, May 1999, Jun 2000, product; dimeric fusion protein consisting of   Jan 2002, Jul 2003, Aug 2003, tumor consisting of tumor necrosis factor   Apr 2004, Sep 2004 receptor linked to the Fc portion of human IgG1)     Engerix-B® (hepatitis B vaccine) GlaxoSmithKline Sep 1989, Aug 1998 Epogen® (epoietin alfa) Amgen Jun 1989, Jul 1999 Fabrazyme® (Algasidase beta; Genzyme Apr-03 recombinant enzyme replacement)     GenoTropin® (human somatropin) Pharmacia Aug 1995, Nov 1997, Jul 2001 Geref® Serono S.A. Oct-97 GlucaGen® (glucagon) Novo Nordisk Jun-98 Gonal-F® (follitropin alfa) Serono S.A. Sep 1998, Jun 2000 Helixate® (antihemophilic factor) Aventis Behring Feb 1994, Jun 2000 Humalog® (insulin) Eli Lilly and Company Jun-96 Humatrope® (Somatotropin) Eli Lilly and Company Aug 1996, Mar 1997, Jul 2003 Humulin® (human insulin) Eli Lilly And Company Oct-82 Infergen® (interferon alfacon-1) InterMune Pharmaceuticals, Oct 1997, Dec 1999   Inc., and Amgen   INFUSEâ„¢ Bone Graft/LT-CAGEâ„¢ Wyeth and Medtronic Sofamor Danek Jul 2002, Apr 2004 (device utilizing recombinant human bone      morphogenetic protein [rhBMP-2-])     Intron A® (alpha-interferon) Schering-Plough Corp. Jun 1986, Jun 1988, Nov 1988,     Feb 1991, Jul 1992, Dec 1995,     Mar 1997, Nov 1997, Aug 1998 Leukine®/Leukine® Liquid (granulocyte Berlex Laboratories Mar 1991, Sep 1995, Nov 1995, macrophage colony-stimulating factor)    Dec 1995, Nov 1996 Norditropin® (somatropin) Novo Nordisk May-95 Novolin L® (insulin; zinc suspension;) Novo Nordisk Jun-91 Novolin N® Novo Nordisk Jul-91 (insulin; isophane suspension)     Novolin R® (insulin, regular;) Novo Nordisk Jun-91 Novolin® (insulin;) Novo Nordisk Oct-82 Novolin® 70/30 (70% insulin isophane Novo Nordisk Jun-91 suspension and 30% regular insulin;)     NovoLog® (insulin aspart) Novo Nordisk May 2000, Dec 2001 NovoSeven® (coagulation factor VIIa) Novo Nordisk Mar-99 Nutropin Depotâ„¢ Alkermes, Inc., and Genentech, Inc. Dec-99 (sustained-release formulation of somatropin)     Nutropin®/Nutropin AQ® (somatropin) Genentech, Inc. Nov 1993, Jan 1994, Jan 1996,     Dec 1996, Dec 1999 Pegasys® (peginterferon alfa-2a) Roche and Nektar Therapeutics, Inc. Oct 2002, Dec 2002 PEG-Intronâ„¢ Enzon, Inc., and Schering-Plough Corp. Jan 2001, Aug 2001 (pegylated version of interferon alfa-2b)     Procrit® (epoietin alfa) Ortho Biotech, Inc. Dec 1990, Apr 1993, Dec 1996 Proleukin, IL-2® (aldesleukin) Chiron Corp. May 1992, Jan 1998 Protropin® (somatrem) Genentech, Inc. Oct-85 Rebetronâ„¢ (combination of Schering-Plough Corp. Jun 1998, Dec 1998 ribavirin and alpha interferon)     Rebif® (interferon beta 1-a) Serono S.A., and Pfizer, Inc. Mar-02 Recombinate® rAHF/ (antihemophilic factor) Baxter Healthcare Corp. Feb-92 Recombivax-HB®/ Recombivax HB Dialysis Merck & Company, Inc. Jul 1986, Jan 1987, Jan 1989, Formulation (hepatitis B vaccine)   Jun-93 ReFacto® (antihemophilic factor) Wyeth Mar-00 Retavaseâ„¢ (reteplase) Centocor, Inc. (subsidiary of Oct-96   Johnson & Johnson)   Roferon-A® (interferon alfa-2a) Hoffmann-La Roche, Inc. Jun 1986, Nov 1988, Oct 1995,     Nov-95 Saizen® (human growth hormone) Serono S.A. Oct 1996, Aug 2004 SOMAVERT® (Pegvisomant; pegylated version Nektar Therapeutics and Pfizer, Inc. Mar-03 of a recombinant human growth hormone analog     structurally altered to act as a GH receptor     antagonist)     TNKaseâ„¢ (tenecteplase) Genentech, Inc. Jun-00 Twinrix® (hepatitis A inactivated SmithKline Beecham Biologicals May-01 and hepatitis B [recombinant] vaccine) (unit of GlaxoSmithKline)   Wellferon® (interferon alfa-n1, lymphoblastoid) GlaxoSmithKline Mar-99 Xigrisâ„¢ (drotrecogin alfa) Eli Lilly and Company Nov-01 Zorbtiveâ„¢ (Serostim® ) (Somatotropin) Serono S.A. Aug 1996, Dec 2003 Source: Bio.org ]]> <![CDATA[50 Branded Biodrugs in India]]> https://biospectrumindia.com/news/95/1124/50-branded-biodrugs-in-india.html https://biospectrumindia.com/news/95/1124/50-branded-biodrugs-in-india.html Tue, 06 Sep 2005 17:06:00 +0530 50 Branded Biodrugs in India 50 Branded Biodrugs in India The entry of Indian firms, with their own brands of recombinant products, has changed the dynamics of the domestic market in India. The Indian biotech products are not only taking head on the leading global brands in terms of quality, but are also increasing their market shares. There are close to 50 branded biotech products in India. The year 1997 marked India's entry into the recombinant biotech market with its own range of biotech products. Hyderabad-based Shantha Biotechnics launched Shanvac-B, an indigenously developed hepatitis B vaccine. Since then there has been no slip back. Companies like Bharat Biotech, Biocon, Biological E, Cadilla, Dr Reddy's Labs, Intas Pharmaceuticals, Panacea Biotec, Serum Institute and Wockhardt have not only left their mark in developing and manufacturing recombinant products in India but also intensifying the race for control of markets. Until then the market was dominated by global majors. Novo Nordisk, a Danish company, became the first to introduce recombinant human insulin in India way back in 1991. Then it was Eli Lilly & Company to launch human insulin under the brand Huminsulin. These two leading names in diabetic care started catering to the needs of diabetic patients in the country by importing human insulin till Wockhardt launched its human insulin under the brand Wosulin in 2003. Later other companies like Biocon and Shreya Life Sciences entered the human insulin market by launching their products under the brand Insugen and Recosulin respectively in the second half of 2004. Now we have as many as six Indian companies with manufacturing capabilities. These companies are marketing about seven recombinant biotech products for the local as well as international market (non-regulated countries). Market scenario In line with global markets, the Indian market too is showing considerable growth in recombinant products. In 2003-04, the Department of Biotechnology (DBT) estimated the domestic market for recombinant therapeutics at about Rs 405 crore. It represents about 3.2 percent of the total Indian pharmaceutical market and 1.6 percent of the world market for recombinant therapeutics. But according to a report on Recombinant DNA Therapeutic Products published by Technology Information, Forecasting & Assessment Council (TIFAC) in 2002, the market of approved recombinant therapeutics has been estimated to be about Rs 535.7 crore, which is approximately 3.2 percent of the total pharmaceutical market of Rs 165 billion in the country. However, with IPR in place in India opportunities exist for speeding up production facilities, based on licensing and other forms of cross-border relationships for all therapeutic products approved for marketing in India, namely Insulin, alpha interferon, hepatitis B surface antigen based vaccine, erythropoietin, streptokinase, and others. Looking at the trends and increase in the number of reported cases of chronic renal failure in India, the erythropoietin market in the country has been on the rise. Growing at a rate of 20 percent, the EPO market was estimated at about Rs 75 crore. G-CSF market is about Rs 20-25 crore and growing at a rate of 25-30 percent. Similarly the FSH market is about Rs 20-25 crore with growth rate of 20 percent. Now the present market size for interferon is about Rs 55 crore. It is growing at rate of 30-40 percent. The insulin market in India is about Rs 251 crore and the human insulin market is growing at the rate of 40.5 percent. The present Hepatitis B vaccine market itself is about Rs 100 crore with huge growth potential. The Streptokinase market in the country is about Rs 80 crore growing at a rate of 25 percent. Considering the overall, recombinant biotech market in India at present is in the range of Rs 500â€“600 crore growing at a rate of 20 percent. However, considering a growth rate of 20 percent, with few exceptions, the TIFAC report observed that the market of these products would be around Rs 958 crore by 2005. At present over 50 recombinant therapeutic products have been approved globally for commercial use. And one fourth of these have already made inroads into India with about 14 recombinant biotech products receiving government approval for marketing in the country. About 40 companies both Indian and multinationals are involved in one of the many activities such as R&D, importing, manufacturing and marketing of recombinant biotech products. Six local companies are into real manufacturing and marketing of these products while 16 companies involved in marketing these products by importing. A few companies like Sun Pharmaceuticals and Torrent Pharmaceuticals are into contract manufacturing of recombinant products for multinationals like Eli Lilly and Novo Nordisk respectively. About 15 leading names in pharmaceuticals and biotechnology industry are investing on R&D activities related to recombinant biotech products. Fourteen recombinant biotech products are available in the country. Local companies have set up the expertise to develop and manufacture seven recombinant biotech products namely Hepatitis B Vaccine, Streptokinase, human Insulin, G CSF, Erythropoietin, Human Growth Hormone and Interferon alpha 2b. The rest all are imported and marketed in India. The indigenous production of these products by local companies has resulted in the drastic reduction of prices and at the same time led to increased consumption. For example, the indigenous production of Hepatitis B vaccine initiated by Shantha Biotechnics Ltd, had resulted in reduction in price of the imported vaccine from Rs 487 per dose (in 1996) by SmithKline Beecham to an average of Rs 150 per dose. We had a similar situation when Indian companies launched erythropoietin and insulin with their own brands after developing indigenously. Insulin In the human insulin space there are as many as seven brands of both Indian companies and multinationals. The brands available in the country include Insugen of Biocon (2004), Huminsulin of Eli Lilly and Company India (1995), Wosulin of Wockhardt (2003), Recosulin of Shreya Life Sciences (2004), Human Mixtard of Novo Nordisk, Insuman of Aventis Pasteur, Human Mixact of USV, Mixulin of Cadila Pharmaceuticals. Most of these brands are available in vial form with different strengths ranging from 40 iu/ml-100 iu/ml. During 2003â€“2004 alone, as many as three companies launched human insulin products under different brands in the price range of Rs 126-129 per 10 ml vial. The human insulin market is growing at the rate of 40.5 percent in the insulin market. Wockhardt was the first Indian company to launch the country's indigenously developed recombinant human insulin under the brand Wosulin at Rs 129 per 10 ml vial in September 2003. Branded BioDrugs in India  Recombinant Brand Human Insulin  Company  Year of Launch Huminsulin Eli Lilly and Company India 1982 Insugen Biocon 2004 NovoMix30 and NovoRapid Novo Nordisk 2003 Recosulin Shreya Life Sciences 2004 Wosulin Wockhardt 2003  Streptokinase     Indikinase Bharat Biotech 2003 Shankinase Shantha Biotechnics 2004 STPase Cadilla Pharmaceuticals 2004  Erythropoietin     Ceriton Ranbaxy 2003 Epofit and Erykine Intas Pharma 2005 Eprex Johnson and Johnson â€“ Cilag AG, Switzerland 1995 Hemax Hindustan Antibiotics 2000 LG Espogenâ€?!Inj LG Chemicals   Shanpoietin Shantha Biotechnics 2005 Vintor for Nephrology /  Epofer for Haematinics Emcure 2001 Wepox Wockhardt 2001 Zyrop Zdyus Biogen    Hepatitis B Vaccine      Bevac Biological E 2004 Biovac B Wockhardt 2000 Engerix-B GlaxoSmithKline India 1995 Enivac HB Panacea Biotec 2000 Gene Vac-B Serum Institute of India 2001 LGEuvax B Inj LG Chemicals   Revac B Bharat Biotech 1998 Shanvac B Shantha Biotechnics 1997  Human Growth Hormone     Humatrope Eli Lilly and Company (India)   LG Eutropin Inj LG Chemicals   Norditropin, NordiLet Novo Nordisk    Saizen Serum Institute of India    Granulocyte Colony Stimulating Factor (G- CSF)      Emgrast Emcure   Grastim Dr Reddy's Labs   Neukine Intas Pharma 2004  Interferon alpha 2a     LG Intermax alpha Inj LG Chemicals    Interferon alpha 2b     INTRON A Fulford India, an affiliate of SCHERING-PLOUGH USA Markferon Glemmark Labs   Shanferon Shantha Biotechnics 2002 Zaveinex Zdyus Biogen    Interferon beta 1a     Avonex Nicholas Piramal India limited â€“Biogen 2004 Blood Factor VIII - Hemophilia Federation of India      Follicle Stimulating Hormone (FSH)     Gonal-F Serum Institute of India Ltd   LG Follimon Inj LG Chemicals   Tissue Plasminogen Acticator       German Remedies    Alpha Drotrecogin     Xigris Eli Lilly and Company (India) 2002 With this it became the first Indian company to launch recombinant human insulin in Asia. Even US Vitamins launched its human insulin product in 2001 but its focus remained on animal insulin. The market for animal insulin products is coming down with increase in human insulin. A year later Bangalore-based Biocon Ltd announced the launch of Insugen, the new generation bio-insulin in November 2004. Insugen was made available to the public in 10 ml vials of 40 iu/ml for an introductory price of Rs 126. Shreya Life Sciences, the Indian arm of Moscow-based Shreya Corporation too launched human insulin under the brand name Recosulin in December 2004, exactly a month after the launch of Insugen. Shreya has launched Recosulin at Rs 128 per 10 ml vials (rate fixed by National Pharmaceutical Pricing Authority (NPPA) by importing the finished product from Bioton, Poland (manufactured using BTGC technology). Besides Indian companies Eli Lilly entered the Indian insulin market a decade ago (in 1995) under the brand Huminsulin. Before that Novo Nordisk launched its human insulin product and went on to introduce insulin analogs under the brand NovoMix 30 (Premixed Insulin Analogue) and NovoRapid (Rapid Acting Insulin Analogue) for the first time in India. In August 2005, Eli Lilly & Co. India too launched its insulin analogs under the brand Humalog Mix 25-50. Although there are many brands in this space from both local and multinational companies, Rajesh Nanavati, marketing controller, Biogen and Biolife, Shreya Life Sciences observed, "I don't see any competition in the market. We want to focus on our USPs to enhance credibility for our products among patients and doctors and look for growth. Our focus is to provide better and quality product to the customers. It will help us to reach our target of Rs 10 crore in one year." Novo Nordisk leads the domestic market as its sales during last year stood at Rs 110 crore, followed by Eli Lilly at Rs 57 crore and Wockhardt with about Rs 9 crore. However, the Indian companies have to put in efforts to capture the market amid stiff competition from the established multinational companies such as Novo Nordisk, Eli Lilly and Aventis Pasteur. This is mainly because diabetes patients have been using brands of multinationals for many years. ]]> <![CDATA[Fermentors business picking up]]> https://biospectrumindia.com/news/95/2390/fermentors-business-picking-up.html https://biospectrumindia.com/news/95/2390/fermentors-business-picking-up.html Tue, 06 Sep 2005 16:22:00 +0530 Fermentors business picking up Fermentors business picking up Fermentors have applications in different sectors and the business is growing at the rate of over 20 percent. Fermentors are the places where proteins for biotechnology are made during upstream processing. In addition to biotechnology, they are used in other sectors such as pharmaceuticals and agriculture. Key players in the fermentors business today include Alfa Laval, Sartorius, Scigenics India, Chemito Technologies, New Labs and Bioengineering. These are supplying fermentors to different sectors such as pharmaceuticals, industrial enzymes and agriculture and also to the educational and research institutes. Besides the leading ones, there are other small companies in the unorganized space. Amar Equipments is into manufacturing and exporting laboratory fermentors. Chemito Technologies has been offering bioreactors /fermentors to many companies and institutes. These are low-cost and industrial lab-scale fermentors. Chennai-based Scigenics India deals with the designing and manufacturing of fermentors and related equipments for life sciences and biotech sectors. It is one of the key players in the manufacture of state-of-the-art bioreactors/ fermentors to meet the stringent demands of the biotechnology-based industries and research institutes. Sartorius is a leading name in the fermentor business in India. The BIOSTATer is a compact autoclavable laboratory fermentor/ bioreactor system from Sartorius. It is an industrial strength system, with the same components and operation philosophy used to power research at leading biotech and pharmaceutical companies worldwide. In pilot scale systems Sartorius has few products namely Biostat C-Duck (10 - 30 L), Biostat D50/D100 (50 â€“ 100 L), Biostat D 300/D500 (300 - 500 L). besides pilot scale systems it has customized systems such as Quadruple Bench-top Setup, Customized Quad Fermentor, Enzyme production plant, Vaccine production plant and Hormone production plant. Alfa Laval is another leading name, which is supplying fermentors. New Brunswick is supplying its range of fermentors through New Labs. Bioengineering, Navin Process Systems, Sneha Engineering Equipment are few other players who are supplying fermentors to companies like Ranbaxy, Cadila Pharma, Cadila Healthcare, Lupin, Wockhardt, Shantha Biotechnics, Bharat Biotech, Biological E, Panacea Biotec, Biocon, Shoshone Chemicals. Alfa Laval has been focusing on projects while Sartorius and Scigenics are focusing on the individual products with their range of products on offer. The local small players are focusing on R&D institutions. "At present all non-API companies are using fermentors. Vaccine manufacturers, pharma food industries, R&D institutes such as TERI, NCL, and CFTRI etc are using fermentors. TERI has one lakh capacity fermentor, Biocon has three-lakh capacity fermentor while companies like Dr Reddy's Labs too have been using fermentors for their R&D activities," said Rajesh Behl, manager, business development, Chemito Technologies Pvt Ltd. S Muthuswamy, director, Scigenics India said, "The companies are selling the fermentors to many industries such as industrial enzymes, pharmaceutical, vaccines manufacturers, agriculture mainly to bio pesticide and bio fertilizer companies. But in the agri sector the market is not in organized form." Commenting on the size of the market, Muthuswamy said, "It is difficult to say the exact size of fermentors business in the country. Last year alone Hyderabad-based companies have purchased fermentors worth Rs 30-40 crore. It is growing at rate of 20 percent." Considering the application in various industries, Rajesh Behl of Chemito Technologies said, "The fermentors business in India will be about Rs 500 crore." Sharing similiar views, S Roy Choudhari, senior store and purchase officer at National Center for Cell Sciences, Pune, said, "There is huge potential for bioreactors/ fermentors in India. Fermentors are used in various R&D institutes including agriculture besides pharmaceutical and biotechnology." Narayan Kulkarni   ]]> <![CDATA[Systat Software]]> https://biospectrumindia.com/news/95/2629/systat-software.html https://biospectrumindia.com/news/95/2629/systat-software.html Tue, 06 Sep 2005 16:18:00 +0530 Systat Software Systat Software's offerings for Bio-Pharma segment Systat Software Inc (SSI), a subsidiary of Cranes Software International Ltd (CSIL), has launched a basket of products for the scientific community in the Bio-Pharma segment. The entire product suite is tailored to meet specific requirements of the scientists to compress the time intensive process of data analysis and presentation, thus enhancing their productivity. SYSTAT provides analytical power with advanced statistics, helps simulates tasks with Monte Carlo features and provides data visualization with more graphing capabilities. SYSTAT with its robust and advanced algorithms is highly recommended by leading biostatisticians. SigmaStat provides expert guidance in analyzing research work. The user-friendly features make analysis fast and easy for the scientific community. SigmaPlot with more than 80 2-D and 3-D technical graph types and a robust regression wizard offers a compelling choice to researchers for publishing their work. The add-on modules like Enzyme Kinetics, Ligand Binding and Electrophysiology make it of special interest to the Bio-Pharma community. SigmaScan is a powerful image analysis tool for a wide range of applications. It quickly converts images to useful data with powerful measurement techniques and is useful for counting, measuring and analyzing digital images. The other products include TableCurve 2D, TableCurve 3D and PeakFit. While TableCurve 2D quickly finds the best equations that describe the data, accurately extrapolates and precisely models exotic data sets, and fits user defined equations with ease, TableCurve 3D finds optimum equations to describe empirical data, helps graphically review surface fit results and eliminate tedious data analysis chores. PeakFit separates overlapping peaks by statistically fitting numerous peak functions to one data set and helps analyze even the most obscure patterns in the data. PeakFit with 83 built-in nonlinear functions is the automatic choice for analyzing data for spectroscopy, chromatography and electrophoresis. For more details, contact: stat@cranessoftware.com Mascon launches ISAP To deal with the vast quantities of sequence data being generated by the various sequencing projects, Mascon has developed an automated, advanced sys- tem for comprehensive sequence analysis and annotation for novel sequences and genomes as well. This approach can be used for high-throughput analysis of sequence data as they are generated and as an application emphasizing regions of interest to researchers to identify genes responsible for the disease. The "Intense Sequence Annotation Pipeline" (ISAP) is unique in terms of functional annotation it provides to a novel sequence. The pipeline consists of five major components: raw data gathering and archival; quality assessment and sequence editing; sequence annotation; novelty assessment and description or submission to local and public databases. The ISAP generates a printable report of each individual analysis and a comprehensive report of all the analysis done for individual sequence as well. The tool can help build the required gene model, which can be authenticated using the ISAP mapping feature. For further details, contact: g.vibhav@mascon.co.in Agilent's protein HPLC-Chip The Agilent HPLC-Chip/MS protein identification solution combines Agilent's advanced tools for protein analysis into an integrated solution for analyzing complex mixtures of proteolytically digested proteins. This solution can quickly and easily identify more proteins. This protein HPLC-Chip incorporates traditional nanoflow liquid chromatograph and mass spectrometer components: enrichment column; analytical column; nanoelectrospray tip; and all connections between the column and the spray tip into a reusable, microfludic polyimide chip the size of a microscope slide. This eliminates post column dead volumes and minimizes sample path length and peak dispersion and results in better-resolved peptide chromatographic peaks. The Chip cube MS interface automatically loads the HPLC chip and the design configuration guarantees that the electrospray tip is in the optimal position for mass analysis when the chip is inserted. For further details, contact: cag_India@agilent.com Atlas Copco launches GX rotary screw compressor Atlas Copco launched Little Master, a GX rotary screw compressor in the range of 3-15 HP. The compressors currently available in the country in the smaller capacity range are based on the sunset piston technology. This means high noise, dullard looks, high power consumption and heavy maintenance costs. Realizing this, Atlas Copco launched Little Master to bring the benefits of screw technology to the small industry. State-of-the-art screw technology enables a compact design and aesthetic look. Energy saving controls coupled with low energy consumption and high efficiency of rotary screw means Little Master gives "more air for less power". Little Master has less moving parts and minimal wear and tear. Service points are grouped together and are easily accessible, making it maintenance friendly. Low power consumption and low maintenance together mean low life cycle cost. Rotary screw technology enables 100 percent continuous duty operation without any capacity drop resulting in high productivity. For details, contact: littlemaster@in.atlascopco.com Randox's protein biochip Randox has announced the release of a protein biochip for measurement of cytokines and hormones in plasma that can aid in the screening and diagnosis of chronic psychosocial stress. Plasma samples from patients on long-term sick leave for a stress induced affective disorder, people at risk of professional burnout and healthy controls were analyzed by a cytokine and hormone biochips using the evidence analyzer in the collaborative study. The markers identified are independently associated with a significant risk of being ill from stress. There are currently no reliable markers of pathological stress related conditions and this new protein biochip offers the first panel of markers to aid in the screening and diagnosis of chronic psychosocial stress. Workplace stress is now the fastest growing cause of absence from work. Stress can lead to illness and has been implicated in the development of many conditions including depression, heart disease and nervous breakdown and therefore can have both wider health and economic implications. The ability to screen individuals for psychosocial stress using a protein biochip will be of value to both insurance companies and governments in assessing employees and populations while the potential to monitor patients on therapy will be of value to clinicians. For details, contact: dipesh.vincwhi@randox.com WAB's DYNO-MILL MULTI LAB DYNO-MILL MULTI LAB, a laboratory agitator bead mill with grinding containers from 0.15 to 1.4 liter, with KD and ECM technology from Willy A Bachofen (WAB) has applications in research, development, cell disruption and small scale for dispersion and wet grinding. Many industries such as agrochemicals, microelectronics, food, microbiology and biochemistry and pharmaceutical and cosmetics are using this. MULTI LAB has application for both discontinuous operation with interchangeable grinding containers of 0.15 and 0.3 liter and continuous operation with grinding containers of 0.3, 0.6 and 1.4 liter. The flexibility of the machine and the availability of contacted parts in so many different materials make the MULTI LAB an ideal laboratory mill to fulfil all requirements. The capacities reached in MULTI LAB tests may be scaled up to the production mills. Milltech Engineering Pvt Ltd based at Mumbai has been marketing this product in India. For details, contact: Sebastian@milltechengg.com Cambrex introduces EndoTrap(R) System Cambrex Bio Science Walkersville now offers EndoTrap System, a new affinity matrix for efficient removal of bacterial endotoxin from aqueous solutions. EndoTrap consists of a very high-affinity ligand material derived from bacteriophages, linked to sepharose beads, to create an easy-to-use flow through column with maximum endotoxin removal capability. Currently available endotoxin removal methods frequently suffer from excessive loss of the protein during the process, making purification an expensive proposition. EndoTrap efficiently binds to endotoxin even at very low concentrations and minimizes binding of the target protein due to the high ligand specificity. Protein recovery in the range of 92-99 percent is possible in most cases. EndoTrap is ideal for removal of endotoxin in cell culture supernatants, in-process material, and protein products. It is available in two versions - EndoTrap Blue and EndoTrap Red. Both versions have similar capabilities for endotoxin removal and selection is based on the ionic strength and pH range of the sample solution. For details contact: biosales@cambrexindia.com ]]> <![CDATA[Endress+Hauser looking at Indian affiliates]]> https://biospectrumindia.com/news/95/6442/endresshauser-looking-at-indian-affiliates.html https://biospectrumindia.com/news/95/6442/endresshauser-looking-at-indian-affiliates.html Tue, 06 Sep 2005 16:14:00 +0530 Endress Endress+Hauser looking at Indian affiliates Endress+Hauser India Pvt Ltd, a subsidiary of the Swiss based Endress+Hauser Group, a global player in the field of measurement instrumentation and automation solutions for industrial process plants is eagerly looking at biotechnology industry as one of the key areas to expand its market in India. Hariprasad Manavalan, industry manager â€“ Pharma & Biotech, Endress+Hauser India Pvt Ltd, said, "We are now focusing on technologies and compliance related to biotechnology and pharmaceutical industries. Headquartered in Mumbai, we have six regional sales offices spread across India to meet the requirements of Indian customers." Endress+Hauser which has implemented instrumentation solutions for projects undertaken by Sartorius, Millipore, Alfa Laval and other original equipment manufacturers in India, already has couple of biotech companies like Biocon Ltd, Shreya Biotech, Shantha Biotech on its list of customers. Having a Corporate Validation Master Plan (according to GAMP IV), it has GXP regulated production centers worldwide. Endress + Hauser has association with regulatory and standards organizations such as FDA, USP, ISPE, ASME - BPE, PAT Committee. It is now looking at Indian affiliates. DPC, Thermo to co-develop clinical chemistry platform Diagnostics Products Corporation and Thermo Electron Corporation have announced that they have entered into an agreement for co-development of a new, high throughput clinical chemistry platform. This platform will integrate with DPC's future immunochemistry platforms, and will be ideally suited for medium and large volume laboratories both in the hospital and private laboratory segments. The combination of DPC's broad experience in immunochemistry with Thermo's clinical chemistry and automation expertise will provide clinical laboratories with a comprehensive diagnostic test solution that will automate most of their routine testing needs. "This new development agreement extends the current relationship between Thermo and DPC to a new level," said Lew Rosenblum, president of clinical diagnostics at Thermo. "The existing distribution agreements, which were put in place in 2004 and cover Thermo's current clinical chemistry and automation products, have already generated excellent results in many European markets," he added. The new system will be distributed exclusively by DPC worldwide except in selected European countries where Thermo will also continue to sell its clinical chemistry and automation products. Pall products play key role in study on cord blood As cord blood increasingly takes front and center stage as a critical source of stem cells for transplants, it has driven the need for consistent quality standards to ensure the safety and efficacy of this life-saving therapy. The newly published results of the landmark COBLT (Cord Blood Transplantation) Study advance standards for cord blood collection, processing and cryopreservation. Along with defining standard operating procedures, Pall Corporation products were the only sets used in the study for the collection, processing and cryopreservation of stem cells from umbilical cord blood. Pall's cord blood sets for collection, processing and cryopreservation are used by the New York Blood Center's (NYBC) National Cord Blood Program, the world's oldest and largest public cord blood bank. Under an investigational protocol and IND filed with the US Food and Drug Administration, NYBC makes cord blood available to physicians treating children and adults faced with a life-threatening illness who need a stem cell transplant from an unrelated donor. Pall's sets are also used by the booming private cord blood banking industry, where pregnant women can arrange to store their own newborn's cord blood in case a family member ever needs it. In addition to providing tools that enable cord blood banking, Pall Corporation is actively involved in applying and adapting its extensive proprietary systems technology portfolio and expertise in blood filtration and separation to the broader field of regenerative medicine, including cell harvesting and purification, adoptive immunotherapies and cytokine production. Applied Biosystems launches drug metabolism assays A preliminary version of Applied Biosystems' TaqMan* Drug Metabolism Genotyping Assays for detection and study of polymorphisms in the drug metabolism pathway is now available through an early-access customer program. There are more than 2,000 unique assays for detection of genetic variants in more than 220 genes that code for drug metabolism enzymes. The TaqMan Drug Metabolism Genotyping Assays are single-tube probe and primer sets for use on Applied Biosystems Real-Time PCR instruments, including the 7300, 7500, and 7900HT Real-Time PCR Systems. Applied Biosystems technology helps to expand salmon conservation project The assays and instruments from Applied Biosystems are being used to monitor wild salmon populations in the Pacific Ocean as part of a multinational genotyping project based at the Alaska Department of Fish and Game. Taking a small piece of fin as a DNA sample, researchers are using Applied Biosystems 3730 DNA Analyzers, TaqMan SNP Genotyping Assays and Real-Time PCR Systems to sequence and then genotype the salmon DNA, identifying SNPs to use as genetic markers in the population studies. As the researchers track salmon migration patterns, intermixing of populations, and identify risk factors, they hope to gain a better understanding of the potential impact of climate change and sustainable fishing practices.   ]]> <![CDATA["We are well-positioned to leave competition far behind"]]> https://biospectrumindia.com/news/95/1781/we-are-well-positioned-to-leave-competition-far-behind.html https://biospectrumindia.com/news/95/1781/we-are-well-positioned-to-leave-competition-far-behind.html Tue, 06 Sep 2005 16:06:00 +0530 New Page 1 "We are well-positioned to leave competition far behind" - Sanjeev Dhar, country manager, Agilent India Agilent India is focusing on the entire life science value chain with backward and forward integration with cutting edge technologies. In an interview, Sanjeev Dhar speaks about the forthcoming plans of the company in India. Excerpts: How is Agilent LSCA planning to consolidate and expand its presence in the life science market in India? Agilent has major strengths in the area of life sciences. Our chromatographic solutions already have the market leadership in the pharma and biotechnology industry. The company is now focusing on the entire life science value chain with backward and forward integration with cutting edge technologies. These include Lab-on-chip, microfluidics, the recently introduced HPLC-on-chip, and bioinformatics. Customers in India benefit from the innovative solutions as they can carry out high quality scientific work within the country. We launched Gene Expression products in India in March this year. These have received tremendous response and we have a focused approach in expanding our gene expression and proteomics portfolio business. What is your long-term vision for the company? In the next three years we would like to see Agilent as the most admired vendor of life science solutions in the areas we deal with. With our cutting edge solutions and customer-centric approach, we are well-positioned to leave competition far behind. We would also make sure that we continue to be the best place to work for our employees. Significantly, Agilent is the only company with life science and chemical analysis business, which has won many awards as "Best Employer in India" and has been consistently figuring among the top 25 companies. We are making appropriate investments in our infrastructure to meet our market growth and employee satisfaction goals. How is Agilent's DNA microarray being received by the Indian life sciences industry? What are the products in the pipeline? We've got a very encouraging response from customers and we are currently working on many active leads. We launched the DNA microarray in March this year and it has been only five months. In this short period we have reached many of the target labs and are working closely with the scientists to provide total solutions. In the future one can expect enhancement of array products and products in the areas of microfludics from Agilent. On the proteomics front also there are opportunities to enhance our mass spectrometry portfolio to cater to life science customers. How do you see life sciences solution companies evolving in the future? Currently we see most solution providers being able to "sell" their solutions. However, moving forward, only companies with total commitment to the life sciences area will be successful. The major reason is that life science solutions are at the extreme end of scientific discoveries and new frontiers. To successfully deploy these solutions, one needs world-class infrastructure. Returns on investment may not be immediate. So solution providers need to have substance to sustain. How would you compare Agilent LSCA India operations with that in other countries? In terms of growth, Agilent India is one of the fourth largest growing business entities in the Asia Pacific. We continue to show a high double-digit growth in last three quarters of our fiscal year and have been gaining high market share rapidly. Agilent India is perhaps the only subsidiary company, which is truly set up as a global company. We have the same infrastructure, systems and processes that our other entities use in the US and Europe. For instance, Agilent confirms to the Sox (Sarbens-Oxly law) in its business practices and we follow the same in India although it is not mandatory as per the Indian law. Most importantly we behave and act like a global company. We use the latest IT support in our operations, continuously measure customer satisfaction and take corrective steps wherever required. We use the latest practices in HR management and lay emphasis on leadership development. What have been some of the key achievements of the company during the recent times? Customer satisfaction has been at the core of our growth initiatives. To achieve our customer goals, we have deployed innovative customer service delivery process which provides ease of call logging and fast turn-around time in problem solving. To that end, Agilent is the only analytical instrument vendor to offer end-to-end service delivery process. This process is extremely successful and is our major differentiator. We have also grown our market share aggressively against our nearest competitors in the last nine months. Agilent has won major deals at top pharma and non pharma accounts. We now have many customers with $1 m-$2 m annual purchase budgets and it is growing. We have also been successful in growing our mass spectroscopy product portfolio for both GC and HPLC product lines. Rolly Dureha ]]> <![CDATA[Pfizer acquires Bioren]]> https://biospectrumindia.com/news/95/7323/pfizer-acquires-bioren.html https://biospectrumindia.com/news/95/7323/pfizer-acquires-bioren.html Tue, 06 Sep 2005 16:04:00 +0530 Pfizer acquires Bioren Pfizer acquires Bioren Pfizer acquired Bioren Inc., a California-based privately held company specializing in technology for optimizing antibodies, for an undisclosed sum. Antibody optimization technologies assist drug companies in developing medicines with improved properties such as greater and longer lasting efficacy. Bioren has developed Walk-Through Mutagenesis (WTMTM) and Look-Through Mutagenesis (LTMTM) technologies to improve the drug development of antibodies. Vicuron merger with Pfizer approved Vicuron Pharmaceuticals announced that its stockholders have voted to approve the merger agreement pursuant to which Vicuron is being acquired by Pfizer. The closing of the transaction is expected to occur in the third quarter, subject to satisfaction of customary closing conditions, including the regulatory approvals. Vicuron Pharmaceuticals is a biopharmaceutical company focused on discovering, developing, manufacturing and commercializing vital medicine for seriously ill patients. The company has two New Drug Applications submitted to the USFDA for its two lead products, dalbavancin, a novel intravenous antibiotic for the treatment of serious Gram- positive infections, and anidulafungin, a novel antifungal agent. Vicuron is being acquired for an aggregate equity purchase price of approximately $1.9 billion. OSI, Eyetech to merge OSI Pharmaceuticals Inc. and Eyetech Pharmaceuticals Inc. announced a definitive merger agreement whereby OSI has agreed to acquire Eyetech, a biopharmaceutical company that focuses on the development and commercialization of novel therapeutics to treat eye diseases. Under the merger agreement, OSI will acquire all outstanding shares of Eyetech common stock at a price of $20 per share in a combination of cash and OSI common stock, for an aggregate purchase price of approximately $935 million, representing a 43 percent premium over Eyetech's $13.99 closing share price on August 19, 2005. "The acquisition of Eyetech represents the rare opportunity to combine two inherently strong growth stories and create a dynamic new entity with real strength. The combination of OSI and Eyetech will create a substantial biopharmaceutical company with over $600 million of projected revenues in 2006 and strong growth prospects for the future," commented Colin Goddard, chief executive officer, OSI Pharmaceuticals. Sigma, Arrow to merge Sigma Company Ltd (Sigma) and Arrow Pharmaceuticals Ltd (Arrow) announced an agreed proposal to merge their businesses to create the leading Australian-owned pharmaceutical company. The merged company will be named Sigma Pharmaceuticals Ltd and will be owned two-thirds by Sigma shareholders and one-third by Arrow shareholders. Based on current market values, the merged group would be valued at approximately $2.2 billion, ranking it close to the 80th largest company by market capitalization listed on the ASX. Inyx to acquire Celltech Manufacturing Services Inyx Inc., a specialty pharmaceutical company with a focus on niche drug delivery technologies and products, announced that it would acquire from UCB, a global biopharmaceutical company headquartered in Brussels, Belgium, all the outstanding shares of Celltech Manufacturing Services Limited (CMSL), a UCB subsidiary. The purchase price is 27.5 million Euros and will be financed through a non-dilutive, asset-based funding facility provided by Westernbank Business Credit Division of Westernbank Puerto Rico. Cardiome to acquire Artesian Cardiome Pharma Corp., a cardiovascular drug development company, has announced to acquire Artesian Therapeutics Inc., a privately held US biopharmaceutical company. Artesian, founded in March of 2002, currently has two advanced small molecule discovery programs in the area of congestive heart failure. Under the terms of the proposed acquisition, the milestone payments will equal, in the aggregate, $32 million for each of the first two drug candidates from the Artesian programs that reach NDA approval. "This acquisition reflects Cardiome's objective of expanding our product pipeline in the cardiology arena," said Bob Rieder, President and CEO, Cardiome. Aptuit to acquire Almedica Aptuit Inc. announced that it would acquire Almedica International for an undisclosed cash consideration. Aptuit, an emerging company focused on streamlining and supporting the drug development process for biotechnology and pharmaceutical innovators, plans to merge Almedica with the Quintiles Early Development and Packaging business units, part of an acquisition announced in July 2005 and scheduled to close September. Almedica currently provides clinical trial materials to more than 150 customers globally, including many of the largest pharmaceutical companies and numerous biotechnology innovators, and has facilities in Allendale, NJ, and Deeside, the UK. ]]> <![CDATA["A huge slew of chemical drugs and biotech products is in the pipeline"]]> https://biospectrumindia.com/news/95/2143/a-huge-slew-of-chemical-drugs-and-biotech-products-is-in-the-pipeline.html https://biospectrumindia.com/news/95/2143/a-huge-slew-of-chemical-drugs-and-biotech-products-is-in-the-pipeline.html Tue, 06 Sep 2005 15:50:00 +0530 New Page 1 "A huge slew of chemical drugs and biotech products is in the pipeline" Dr NK Ganguly, director general, ICMR. The Indian Council of Medical Research (ICMR) is spearheading the development of new drugs and policy guidelines for facilitating cutting edge research. In an exclusive interview, Dr NK Ganguly, director general, ICMR, elaborates on the new initiatives taken by the Council. What are the latest initiatives taken by ICMR in the area of biopharma/biotech drugs? We have undertaken a number of promotional activities in the area of biotech/biopharma research. One of the activities has been in the area of drugs for neglected diseases. We have been making efforts to make these drugs available, which are badly needed for some of the diseases and for which there is in adequate funding. One of ICMR's success has been an oral drug for Kala Azar. Though this drug, Miltefosin was known earlier, it was mainly used as an anti-cancer drug. Its introduction and trial in leishmania was formulated and carried out through our team of investigators at the Rajendra Memorial Research Institute of Medical Sciences (RMRI) in Patna. The clinical trials were done in Bihar and the trial sites were 15 GCP labs in the state. The trials have been completed successfully and we have now partnered with the WHO. Then, in association with the Bill and Melinda Gates Foundation, we are conducting the clinical trials for Paramomycin drug. This is also an earlier known drug but is not in use for leishmaniasis. Within the country, we have partnered with the Council of Scientific and Industrial Research (CSIR) for two anti-malarial drugs. The clinical trials for these drugs are over and now both are in the market. At the moment we are also conducting trials of a combination drug for Malaria. For combination drugs we are trying to bring in different combinations and trying to reach out to sites which are very tricky like the Indo-Nepal border and Orissa. So these are some of our efforts in the area of neglected diseases. Then, with Lupin we are trying to develop a new anti-tubercular drug. This will bring down the existing time of treatment to three months. At the same time we have already done a trial with a combination drug which reduces the time of treatment for tuberculosis to four months. We have also developed a new treatment regime for leprosy and this is backed by a very good diagnostic test. Its clinical trials have already been successfully completed. We have also introduced a biotech drug, Thrombin - a clot buster, which is going to Phase I trials. This drug is aimed at early stroke victims. In the area of HIV, we have at the moment, one phase I clinical trial going on for HIV vaccine, and the trials of the second HIV vaccine will start in the first week of September in Chennai. For this, all the clearances have been obtained, the volunteers are in place and the recruitment has started. We have also started a recombinant Cholera vaccine trial at NICD (National Institute of Cholera and Enteric Diseases), Kolkata and we are doing a trial for salmonella vaccine, which will be comparatively a cheaper vaccine. Then with GAVI funding (Global Alliance for Vaccine and Immunization), funding from the US and the Bill and Melinda Gates Foundation we are doing a major trial for Hib vaccine (Haemophilus influenzae vaccine). A Joint ICMR and Johns Hopkins University Hib vaccine probe study is on the cards to improve the information base regarding the use of Hib vaccine in the region. The Council is working on a Phase I trial for providing the second dose of measles vaccine and we have started an aerosol measles vaccine trial with funding from GAVI. To tackle the Human Papiloma virus, which causes cervical cancer, we are holding talks with Merck to conduct a papilomavirus vaccine study. Now a MoU is on the anvil. Another major trial, spanning over ten centers, on Hepatitis B and C is going on. So there is a huge slew of chemical drugs, biotech products in the pipeline. We help in launching them in India on the condition that the drug will be available in India at an affordable price and that the government of India will be a partner so that they know that how these products are coming in. Another notable feature is that most of these initiatives are examples of public-private partnerships. Biomedical research is evolving very rapidly. How is ICMR facilitating research in this scenario? Taking note of the fast changing developments in biomedical research, we have constituted a few committees here within ICMR, to provide guidelines like a committee on toxicology, a committee on drug trials and a committee on ethics, which will be known as the National Ethics Committee. This will look into ethics-related issues in the trials. We are setting up a large number of clinical trial centers in the country. We are also trying to set up a Clinical Trial Registry Council, so that anyone who is registering in this field will ultimately have accreditation from the Council. We have also tried to help and promote drug companies in India. We have set up a set of toxicology units in the country. One such unit in Hyderabad did the toxicology studies of DNA rabies vaccine for dogs and of the interferon alpha, which has been developed by Shantha Biotech. So we have set the way of doing toxicology studies for biotech products/drugs. We also look after the clearances of the IND molecules. Earlier, this used to take a lot of time and now we have been able to shorten the time to less than two months. Leveraging the expertise of the Council, we have now set up a system for clearances. We have put up the ethical guidelines, which are a part of the GCP guidelines; have helped in modifying the Schedule Y and the GCP guidelines of the Drug Controller General of India. And we have created a module for adverse drug reaction monitoring. We are formulating a guideline for stem cell therapies and biologicals. We have also developed guidelines for medical devices which did not exist till date. In addition, we are setting up a National Drug Authority, an autonomous body, on the lines of the Federal Drug Agency and the land required for this has been purchased. ICMR is working towards setting up a pharmacovigilance network. We had started such a network about seven years back on some selected drugs and now we have to look at it in the modern day perspective. To provide infrastructure support, we are setting up a primate breeding facility at Sasunavgarh, Mumbai and a large animal facility on a corporate model in Hyderabad to promote drug development and pharmacological development of products. The land has been acquired for this purpose. We have set up a microbial containment facility in Pune, which I think is the largest in the country for the viral infections. This will help us in tackling any viral infection and we have put up a depository of viruses so that researchers can develop products which can be utilized to tackle outbreaks. From the medical research perspective, we have funded over 1000 research efforts and also help in patenting the products that come out of this research. We fund our own institutes for newer areas of research. We have funded some projects on drug development in malaria and tuberculosis, vaccines, new molecule and drug targets. ICMR has initiated an annual event called "Medical Development Congress". Can you elaborate on this? The Medical Development Council will essentially bring together all stakeholders who are interested in developing products for improving health and find out what we have been able to put in place and what is further needed. So it is a kind of introspection as well as looking towards the future. We would take cognizance of new developments and would discuss strategies to develop products that will be of use for us as well as for the developing world, as a whole. The Council will provide a forum where interactive dialogue, knowledge-sharing and brainstorming sessions for joint strategy development will be undertaken on a regular basis. The event would address specific issues pertaining to medical development every year and provide a platform where industry leaders, R&D institutions, government agencies, interested ministries and select management experts will share their experiences, raise questions, suggest measures to improve the quality of medical care, increase its international competition and make it more affordable and accessible to the common man. The very first Medical Development Congress will be held in November 2005 in Delhi with the broad topic of "Drugs & Pharmaceuticals" as its central theme. Since this area is vast, the meeting will focus on infectious diseases. The event will cover therapeutics related to the development of new molecules, new herbal formulations, relevant delivery systems, diagnostics and new devices. Rolly Dureha "Imperial Is Creating an India Foundation" Dr Colin Wyatt, director of Business Development, Imperial College, London With the mutual business in India and the UK growing, what are Imperial's plans for India? The Indian business investing in the UK went up 47 percent in 2003-04. Almost 28 new companies from India invested in the UK, with the total now touching 480 (338 from ICT). While the UK is the second largest investor into India, India is the eight largest investor into the UK. Clearly, the mutual Indiaâ€“UK investment has been growing rapidly. Besides, the Indian R&D funding is growing too. The Science & Technology research currently is about 0.6 percent of GDP and it is touted to increase to 2 percent by 2007. We recognize the potential and are looking at a number of things. As an academic institution, we are looking to build academic relationships with India. Towards this, Imperial is creating an India Foundation to promote higher education, research collaboration and the funding of Indian post graduate students at Imperial College. The Foundation will focus on education and collaborative research to promote higher education at post doctoral level. It would identify and promote collaborative research projects in India as well as in the UK at the university/institution levels. In the commercial context, we are looking at building more relationships with the Indian commercial organizations, both in the life sciences and non life sciences sectors. These could be biotech or healthcare or devices companies. We are already in discussions with some of the major companies in India. Could you elaborate on the India fund that you plan to create? What we are looking at is creating and managing a fund that will help students to do a higher research. This is the first time such a fund is being planned to be created. This is to raise money in India to fund postgraduate (MSc, MBA and PhD) scholarships for talented Indian students to study at Imperial College, and to assist in creating an enhanced awareness of the benefits of higher education, promotion of the College's overall objectives in India and to raise the profile of Imperial College in India as a preferred destination for aspiring Indian students. We are in the process of identifying possible sources of funding. What do Imperial's subsidiary companies do? Imperial Innovations, is a partially owned subsidiary with external investors, and commercializes existing intellectual property and is focused in the area of technology transfer. The goal is to protect and market technologies to realize value from the intellectual property, typically through licensing and spin-out formation. Besides Imperial Innovations also supports early stage companies by providing access to networks of investors, management teams and incubation space, supports portfolio and asset management, and manages the spin-out portfolio and spin-out investments. Imperial Consultants, a wholly owned subsidiary company, provides consultancy. It offers technology-related services for industry, gives the link to a network of highly specialized academic experts from Imperial, and facilitates direct access to some of the best research facilities, analytical and testing equipment in Europe. How does your model work in a coordinated way? The University has three groups - consulting, technology transfer, and business development. We are all part of the same platform of Imperial's corporate affairs. We have formal communication processes. The heads of each unit meet every month on a formal basis. But over and above that what we do with the business development group is try and be some glue to hold all the units together. So we have joint team meetings once in a month. We are all co-located and talk to each other every day. We have recently put in place a common CRM system and database, which we all use to log on the activities of what we are doing, the people that we are talking to, the projects that we are working on, and many more. So there is an informal and formal communication and coordination with the other two groups. The business development group spans both groups because the relationships are built between the industry and academia. Academia has a strong intellectual property component, so Imperial Innovation has to be involved in the dialogues. Similarly, where there is a consulting component and Imperial Consultants may be involved. However, they can do things independently too. What has been the outcome of this model? The commercialization activities are returning substantial value to the College. Research funding from industry per year is nearly £30 million now. About 10-12 inventions get recorded per month and close to 50 patents are being filed per year. While the licence income collected is now around £7.1 million, there are over 60 spin-out companies in the portfolio. Over £150 million of spin-out finance has been raised and the overall valuation of the portfolio is in excess of £300 million. The valuation of Imperial Innovations is about £60 million. And over £25 million of funds have been returned to the host institution. What are some of the key trends that you foresee in the next few years? We need to get better at integrating all the aspects of commercialization. We need to improve the links between the academic communities and the business development communities, in terms of awareness and perception of working together. In the UK context, there are certain inbuilt tensions between academics and commercialization. The primary drivers of motivation for academics are to develop research excellence. In the UK, this is determined by the research assessment exercise. Such exercise determines the funding that the university gets. Historically, one of the parameters of research excellence assessment was the number of publications in quality peer review journals and number of post-docs, etc. being supervised and managed. Industrial research revenue was never an important consideration. Because of this, there is a degree of misalignment between the two requirements--industry sponsored research versus public-funded research. This can create problems in reducing the motivation in working on a industry-sponsored research, particularly around now, as we are in the run up to the next research assessment. The next two years are important to the universities and academics. The government is aware of this problem and it is likely that the matrix of the research assessment exercise will be modified. It is not yet entirely clear. Looking forward, we would like to see those conflicts taken away. The business development process should be seen as a fundamental part of the way universities run themselves, just as any other function. Over the next five years, business development will be seen emerging as a core function. ]]> <![CDATA[Sabin Institute honors Dr Poonawalla]]> https://biospectrumindia.com/news/95/2063/sabin-institute-honors-dr-poonawalla.html https://biospectrumindia.com/news/95/2063/sabin-institute-honors-dr-poonawalla.html Tue, 06 Sep 2005 15:41:00 +0530 Sabin Institute honors Dr Poonawalla Sabin Institute honors Dr Poonawalla Dr Cyrus S Poonawalla receiving the Sabin Humanitarian Award from Dr Seth Berkley, president and CEO of International Aids Vaccine Initiative (IAVI). The New York-based Sabin Institute has honored Padma Shri awardee Dr Cyrus S Poonawalla, chairman and managing director, Serum Institute of India Ltd, with its Humanitarian award. The award was given in recognition of his commitment for making available vaccines to protect the under-privileged children of the world at very affordable prices, with the result that the UN Agencies recognizing this fact have purchased these vaccines at low cost to protect the world's infant population against communicable diseases. Dr Poonawalla also received the Global Corporate Philanthropy award on behalf of Serum Institute for excellence in quality healthcare and the philanthropic policy pursued by Serum Institute right from its inception. Dr Poonawalla was among the six distinguished international personalities to have been recognized by Sabin Institute, notably among them was the famed Larry King. Dr Poonawalla received the Sabin Humanitarian award at the hands of Dr Seth Berkley, president and CEO of International Aids Vaccine Initiative (IAVI). Receiving the award, Dr Cyrus Poonawalla said, "It gives me great pleasure and privilege to receive the award by the famed Sabin Institute. This award is a tribute to Serum Institute's 'Philosophy of Care' and commitment of 'Health to All'. Our aim and objective is to make available life saving serums to the masses of India at affordable prices. Our vaccines are available at prices that are within the reach of common man. I hope to have the strength to pursue the same philanthropic policy whilst launching newer vaccines in the future." Dr Poonawalla lauded Sabin Institute for selecting a company in the developing world, perhaps for the first time, for this coveted award. He expressed his gratitude for the support and assistance rendered to SII by several UN and international agencies over the years. Prasanta is new CEO of IBPL Prasanta Biswal is the new chief executive officer of International Biotech Park Ltd (IBPL). He is joining the TCG Real Estate with 18 years of experience and expertise in the different areas of foreign investment promotion, international business development and SME development. With a Masters Degree in Economics from Delhi School of Economics, Prasanta worked with several organizations at different levels such as director of FICCI-USA and managed FICCI's US operations; as a consultant to the Planning Commission and as the Indian delegate, nominated by the Ministry of Industry to participate in an investment promotion program under the Delegate Program of UNIDO for increased flow of Italian investment and technology into India. Prof. Samuelson bags Chemito Award Prof. AG Samuelson, professor, inorganic & physical chemistry, Indian Institute of Science, Bangalore was declared winner of the Chemito Award 2004 for excellence in applied research in the field of analytical techniques. Prof. Samuelson has been involved in research activities that are focused on structure-reactivity and structure-property relationships. Constituted in 1998 in the memory of BD Toshniwal, a pioneer in analytical instrumentation in India and the founder of Chemito Technologies, the Chemito National Award of Excellence recognizes significant contributions in the areas of applied research carried out using an instrumental technique (preferably chromatography or spectroscopy)/applied research in the field of chemistry and life sciences. The award carries an endowment of Rs 20,000, a certificate and a citation. ]]> <![CDATA[TCS bags drug discovery deal]]> https://biospectrumindia.com/news/95/2322/tcs-bags-drug-discovery-deal.html https://biospectrumindia.com/news/95/2322/tcs-bags-drug-discovery-deal.html Tue, 06 Sep 2005 15:14:00 +0530 TCS bags drug discovery deal TCS bags drug discovery deal Tata Consultancy Services (TCS), a leading global technology services company, announced that it has entered into an agreement with Congenia, a biotechnology start-up promoted by Italy's Genextra Spa group to provide advanced fragment-based lead optimization solutions for drug discovery. The agreement is the first of its kind for an IT company. The Life Sciences R&D Division of TCS will work on "P66", a target protein identified by Congenia as a key protein involved in several age-related diseases and will develop optimized drug leads based on this. Dr M Vidyasagar, executive vice-president and head of TCS' Advanced Technology Centre, Hyderabad, which houses the Life Sciences R&D Division along with other activities, said, "This is a historic occasion for TCS and the first contract where the deliverable is not software code, but a set of molecules. We are proud to partner with the Genextra group, a bio-tech pioneer in Italy." TCS is committed to putting in place a complete suite of offerings in the life sciences segment, spanning genomics and proteomics, database integration, drug discovery, and preventive healthcare, Dr Vidyasagar added. TCS will be using modules of its own product "Bio-Suite" to work on the target protein. It will screen a "virtual fragment library" of tens of thousands of potential lead molecules to predict which of these might bind themselves to the target protein and thereby inhibit its function. TCS will also produce a first-cut analysis of the ADMET (Absorption, Distribution, Metabolism, Excretion, and Toxicity) profile of the lead molecules. The optimized lead molecules produced by TCS will be further developed by Congenia through animal trials and eventually human clinical trials. The work will be executed in the Advanced Technology Centre of TCS. Wet chemistry and crystallography work will be carried out by TCS' sub-contractor, Altiora Ventures in Israel. The biological assays will be carried out by Congenia in Milan, Italy. The contract has a duration of 18 months, and incorporates payments based on the number of optimized lead molecules delivered. Paolo Fundaro, CEO of Congenia said, "TCS' competencies in bio-chemistry and computation techniques offer a unique value proposition. Using these techniques, we expect to obtain good lead candidates for a drug for pre-clinical trials and save time in R&D." Bharat Biotech to set up factory in Malaysia Hyderabad-based Bharat Biotech International Ltd will be setting up its first overseas plant in Perak, Malaysia. The new plant will be built at the pharmaceutical park in Seri Iskandar and will produce vaccines for typhoid and Hepatitis B, besides other recombinant products. Dr Krishna M Ella, chairman and managing director, Bharat Biotech said the company would be investing about RM50 million in the new plant's manufacturing, and research and development divisions. Bharat Biotech signed a memorandum of agreement with Remco Engineering and Consultancy Sdn Bhd and Perak Development Corporation (PDC) towards this. Under the joint venture, Bharat Biotech will be responsible for providing the technical expertise, while Remco Engineering will build the plant. PDC is the land owner. Dr Krishna informed that the vaccines manufactured at the Perak plant would be used to penetrate the Middle East and Asian markets, particularly Indonesia. The new plant will be ready by the middle of 2006.   ICRISAT DG meets World Bank President The Director General of the International Crops Research Institute for the Semi-Arid Tropics (ICRISAT), Dr William Dar, met the President of the World Bank, Paul Wolfowitz, in Hyderabad. Dr Dar, who is also the Chair of the Alliance Executive of the Future Harvest Centers of the Consultative Group on International Agricultural Research (CGIAR), thanked Wolfowitz for the World Bank support to the CGIAR and ICRISAT. The Bank is investing $50 million per year to the CGIAR system and such investment is very focused on the rural poor in most developing countries of the world. The CGIAR is a strategic alliance of countries, international and regional organizations, and private foundations supporting the 15 international agricultural Centers. ICRISAT is one of the 15 centers that are part of the CGIAR.   Biocon, Nobex sign research agreement Biocon Ltd and North Carolina's Nobex Corporation have announced a global research collaboration to jointly develop an oral peptide product for the treatment of cardiovascular disease. Biocon and Nobex plan to advance the oral human brain-type natriuretic peptide (hBNP) program towards an IND (Investigational New Drug) filing with the FDA (US Food and Drug Administration) in 2007 and clinical trials beginning later that year. The FDA approved administration of hBNP by continuous infusion in August 2001 for the treatment of acute congestive heart failure (CHF) in the hospital care setting. The intent of an oral hBNP would be to have a product available for chronic use, rather than only for acute use for a number of potential indications, including early-stage heart failure patients. This will herald a new paradigm for potentially multiple indications in cardiovascular therapy. "Biocon is tremendously excited at the opportunity to partner with Nobex on such an important product opportunity. By co-developing a therapeutic product such as oral hBNP of substantial clinical and market value in treating heart failure and other potential cardiovascular indications, we are taking another step towards our innovative product development strategy," said Kiran Mazumdar-Shaw, chairman and managing director, Biocon Ltd.   Eli Lilly launches insulin analogs in India Eli Lilly & Company unveiled 'Humalog Mix', the insulin analog mixtures in India. Humalog Mix, called as designer insulin by the specialists, offers people with diabetes convenience, control and flexibility. It absorbs quickly and starts working within minutes to lower blood sugar. In fact, Humalog is the first mealtime insulin prescribed by doctors who specialize in treating diabetes, and would be available at Rs 389 per cartridge. Speaking at the launch of Humalog Mix in Mumbai, Rajiv Gulati, chairman and managing director, Eli Lilly India, said, "The challenge in diabetic care is to add quality to the patient's lives, giving them freedom of dose administration and minimize hassles in the therapy. With Humalog we aim to meet and overcome these challenges". Humalog Mix is available in three different variations: Humalog insulin lispro (rDNA origin), Humalog Mix 25 and Humalog Mix 50. These analog insulins are used as part of total glucose management that enables better long-term health. Humalog Mixtures provides both fasting and postprandial control and thus can help in preventing short term and long-term complications. Humalog Mix25 and Humalog Mix50 meet a number of patient and physician needs. They provide the convenience and mixing accuracy of pre-mixed insulins with the benefits of the unique rapid action of Humalog. Both are more physiological than human insulin mixtures and also improve postprandial blood glucose control and reduce glycemic excursions. Rajiv Gulati further said, "Future would see more and more innovation in the area drug administration, formulations all aimed at improving patients' lives and we at Lilly would endeavor to be the first ones to bring these to Indian public."   Bhan urges students to strive for innovation Lauding the achievements of students at the annual convocation of the Institute of Bio-informatics and Applied Biotechnology (IBAB), Dr MK Bhan, secretary, DBT, government of India told them to inculcate the spirit of innovation. "It is not investment which is the problem. It is the lack of innovation and discovery that is the issue. We lack the will to persist when difficulties arise," he said. He told students to make the most of the current atmosphere in India where there is mobility, flexibility and possibility. "India had forgotten to reinvent and reengineer. But Bangalore has demonstrated the power of reinvention," he said. He called for institutions like the IBAB to try and balance the path between cooperation and competitiveness. The third annual convocation awarded certificates to post graduate students in bioinformatics and biotechniques. Prof N Yathindra, director, IBAB said that the institute was trying to formalize the degree recognition process. Scholarships and medals sponsored by biotech companies like Millipore, Sartorius and the chief minister, were awarded to meritorious students. He also hoped that the institute would move into the proposed biotech park campus - Bangalore Helix in Electronic City next year. He also requested the biotech industry to continue augmenting IBAB by providing infrastructure and support. CyberMedia News   ]]> <![CDATA[Biotech is the flavor of the century: Dr Joseph Thomas]]> https://biospectrumindia.com/news/95/2234/biotech-is-the-flavor-of-the-century-dr-joseph-thomas.html https://biospectrumindia.com/news/95/2234/biotech-is-the-flavor-of-the-century-dr-joseph-thomas.html Tue, 06 Sep 2005 15:07:00 +0530 Biotech is the flavor of the century Biotech is the flavor of the century: Dr Joseph Thomas Dr Joseph Thomas, adviser, Biotechnology (BT), IIT Madras, inaugurating the second BioSpectrum Student Lecture Series at IIT Madras. It was sponsored by Sangene Biotech and RK Institute of Management and Computer Science, both based in Bangalore. The second BioSpectrum Student Lecture Series was organized in Chennai at the prestigious IIT Central Lecture Theatre on August 27, 2005. Over 350 students from various institutions in the state attended the event with full enthusiasm. Inaugurating the event, Dr Joseph Thomas, adviser, Biotechnology (BT), IIT Madras, said, "Biotech will be the flavor of the century and is expected to enhance the quality of life. And biotech, which will have a direct interaction with the human lives would out run the IT industry in future." Over 2,000 students from Chennai will be coming out with a biotechnology degree, he informed. BioSpectrum Student Lecture Series, is an event where leading personalities from the industry address the biotech students' concerns on careers and opportunities in biotech sector, and was flagged off in July this year in Bangalore. This Series will be held across 10 cities in the country over the next six months. "Biopharma industry contributes nearly 75 percent to the biotechnology industry and clinical research is expected to become $1 billion industry by 2008 in India," Dr Thomas said and added that India would witness a transformation in the field of research and the Research Process Outsourcing (RPO) is expected to be the next new wave overcoming the present BPO industry. BioSpectrum editor, N Suresh, giving an overview of the Indian and global biotech industry in India, said, "The present government under the leadership of Prime Minister Manmohan Singh swears by BT." The government initiatives in supporting the development of the industry has been tremendous, by bringing in industry-specific acts. Further, he said that Biotech has seen a good growth within five years and today the Indian biotech sector has crossed the $1 billion mark (Rs 4,745 crore). While 40 percent of the business generated is by companies headquartered in the West, South accounts for 38 percent of the business, and the rest is generated by companies located in the North, he added. The coming up of biotech parks similar to that of IT parks in Bangalore, Chennai, Chandigarh, Hyderabad, Kerala, Pune, etc. has become the new trend in the country. Good revenue and profits from the industry and assistance from the government has facilitated in opening these parks, he said. Speaking on the BioSpectrum role, Suresh said the lecture series was a very good opportunity for the students, who could interact with the best in the field and clarify their queries regarding the industry and their future. He added that by the end of this year BioSpectrum will launch an Asian edition. This would be the first Indian magazine to be published outside India. Speaking on the BioPharma opportunities Dr SV Veerramani, CMD, Fourrts (India) Laboratories and vice president, Indian Drug Manufacturers Association, said, "The pharma industry has grown tremendously in the last five years and it is $8 billion business in India. Though it is only 2 percent of the global market and 1 percent of the total global production, there is a good growth for the business due to the unbeatable medical prices and affordable and quality manpower. The biotech industry touched the $1 billion mark in 2004 and will touch $5 billion by 2010. India is also going good on the patent rights with many Indian companies coming up to patent their products." The past was not evolved, the present is maturing and the future is bright for the BioPharma, he surmized. Talking about the career opportunities, he said the opportunities were vast in the manufacture, R&D and clinical segment and the industry is promising one million jobs by 2010. Dr GK Suraishkumar, professor and head of biotechnology department, IIT Chennai, elaborated on the opportunities in the biotech research, while Dr Tomal Dattaray, director, Metahelix, Bangalore, elaborated on the trends in BioAgri, KO Isaac, managing director, ABL Biotechnologies, Chennai, addressed on the trends in biomarine industry. The Student Lecture series facilitated an interactive session with the speakers. The speakers answered the most common question, which was basically about the industry and their future in it. The event was sponsored by Sangene Biotech and RK Institute of Management and Computer Science, Bangalore. ]]> <![CDATA[Stem Cells: Premises & Promises]]> https://biospectrumindia.com/news/95/1099/stem-cells-premises-promises.html https://biospectrumindia.com/news/95/1099/stem-cells-premises-promises.html Tue, 06 Sep 2005 15:01:00 +0530 Stem Cells   Stem Cells: Premises & Promises The National Institute for Research Health, Indian Council of Medical Research, Indian Society for the Study of Reproduction and Fertility and Histostem, Inc., USA, will conduct an international symposium on "Stem Cells: Premises & Promises for Research & Therapeutics", in Mumbai on September 18-21, 2005. The symposium will be an interactive forum for scientists involved in stem cell research to deliberate on the current scenario and identify future directions for research and therapeutic applications. The symposium would also serve as a platform to enhance awareness of the advances in stem cell research among the scientific community, to develop interactions between the scientists, and to establish linkages with national and international institutions working in the area. For more details, contact: stemcells@indiatimes.com; stemcells@rediffmail.com   Drug Discovery to Clinical Trials IBC Life Sciences will organize Drug Discovery to Clinical Trials conference on October 5-7, 2005 in Mumbai. The meet will feature a session on the "Current Status of Intellectual Property Rights in Asia" and a panel discussion on "Moving from a Fee-for-Service/CRO Model to an Innovation Model in India and China: Challenges and Opportunities". Proposals for poster presentations at the event on scientific and business topics are currently being accepted and the deadline is September 14, 2005. For more details, contact: enquiry@ibcasia.com.sg   Pharma Expo 2005 Pharma Expo 2005, the second edition of international pharmaceutical exhibition and conference organised by the Confederation of Indian Industry (CII), will be held on October 20-22, 2005 in Mumbai. The three-day event will bring together the manufacturers and suppliers of process, plant and equipment for the growing pharmaceutical industry. As a dedicated platform for the pharmaceutical manufacturing industry, the exhibition will provide a great opportunity for service providers to showcase their products and services to decision makers. For details, contact: anil.padwal@ciionline.org   BioProcess International BioProcess International Asia Pacific, an international biopharmaceutical/biologics development, production and manufacturing conference will be held in Singapore on November 7-9, 2005. The 3-day conference will provide critical information on the biopharmaceuticals production and development industry, that spans across 10 Asia Pacific countries, specially addressing the needs of US, European and Asia Pacific regional executives and scientists who are looking for global alliances and technological innovations, as well as ways to improve their bioprocessing capabilities and skills. For more details, contact: enquiry@ibcasia.com.sg   Pharmaceutical Regulatory Affairs meet Pharmaceutical Regulatory Affairs meet will be conducted on September 26-27 in Singapore. The meeting will give an overview and introduction to pharmaceutical regulatory affairs in the major markets in Asia. It would also discuss regulatory procedures and requirements for the approval, particularly of new pharmaceutical products, clinical trials needs and opportunities and optimal regulatory strategies. For more details, contact: enquiry@ibcasia.com.sg   PABORD 2005 PABORD 2005, a pharmaceutical and biotech outsourcing, research and development exhibition and conference, will be held in London on September 14-15, 2005. The event will focus exclusively on the theme of outsourcing in the research and development of new medicines. Companies both large and small are adopting this increasingly popular business strategy. The conference is relevant to service providers and R&D organizations active across the entire discovery and development chain from lead generation to product registration. For more details, contact: info@pabord.com   Short course on mammalian cell culture The Department of Biotechnology of the Indian Institute of Technology (IIT), Madras, is organizing a two-day short course on mammalian cell culture on September 19-20, 2005, at the Centre for Industrial Consultancy and Sponsored Research (ICSR Building, Hall 3), Chennai. This course is designed for industrial biotechnologists and academic researchers, interested in learning the current practices and exploring the future trends in mammalian cell culture biotechnology. It will present an interdisciplinary approach, covering both biological and engineering aspects of mammalian cell culture. The deadline for registration is September 12, 2005. The contact person, Prof. Guhan Jayaraman can be reached on 044-22576108 (e-mail: guhanj@iitm.ac.in). The course co-ordinator, Prof. Dhinakar S Kompala can be reached on 9840468265 (e-mail: Kompala@yahoo.com) For registration and course details, visit www.biotech.iitm.ac.in   BIO Mid-America VentureForum 2005 The 2005 BIO Mid-America VentureForum will be held in Minneapolis-St Paul, on September 21-23, 2005 at the Hilton Hotel, Minneapolis, USA. The Midwest's largest annual event will showcase biotech and medical device product and platform companies from across the country. The event will provide a platform for venture capitalists, start-up biotech and medical device entrepreneurs, and other industry participants to meet and explore funding and investment opportunities and forge business partnerships. For more details, contact: BIOMidAmerica@bio.org   BioDefense and BioNanoMedicine-2005 BioDefense and BioNanoMedicine-2005-Boston meeting on "Infection, Inflammation,Immunity and Bionanotechnology" will be organized by GeneExpression Systems, Inc on November 6-8, 2005. Innovators and authorities in the fields of inflammation, immunity and infectious diseases from the academic, biotech and pharmaceutical communities will speaking on pulmonary diseases, bacterial and viral pathogenesis caused by anthrax, plague, francisella, tuberculosis, HIV, hepatitis, vaccine development and global healthcare policies. In addition, use of Nano-particles and quantum dots in diagnostics and other medical arenas will be discussed. Special emphasis will be given on nano-particles applications for better gene and drug delivery purposes. For more details, contact: Genexpsys@expressgenes.com   Micro Biotech 2005 The Association of Microbiologists in India (AMI) will conduct Micro Biotech 2005 conference in Hyderabad on December 8-10, 2005. The theme of the conference is "Micro-Biotechnologies" focusing on biotechnologies based on live microorganisms relevant to all major areas of microbiology like microbial biotechnology, industrial microbiology, food microbiology, microbial technologies for environmental management, agricultural microbiology, medical and veterinary biotechnology. Leading microbiologists of the country from various institutions and industries will address the delegates. There will be invited lectures and a special session exclusively for students. The conference will also feature an exhibition of books and equipment. For further details, contact: vrlinga@yahoo.com or orgsec.abs@gmail.com   BIO InvestorForum 2005 BIO InvestorForum 2005 will be organized on October 19â€“20, 2005 at The Palace Hotel, San Francisco, CA. Hosted by BIO (Biotechnology Industry Organization), the largest industry organization focused exclusively on biotechnology, BIO InvestorForum 2005 will bring together industry investors with the management of top life sciences growth companies, as well as the companies poised to join the growth "watch list" for 2006. For more details, contact: bioinvestorforum@bio.org ]]> <![CDATA["Ethics will be the gateway for clinical research in India"]]> https://biospectrumindia.com/news/95/1339/ethics-will-be-the-gateway-for-clinical-research-in-india.html https://biospectrumindia.com/news/95/1339/ethics-will-be-the-gateway-for-clinical-research-in-india.html Tue, 06 Sep 2005 14:56:00 +0530 New Page 1 "Ethics will be the gateway for clinical research in India" In an exclusive interview, Dr Francis P Crawley, secretary general and ethics officer, European Forum for GCP, elaborates on the scenario in the area of clinical research. Globally which are the regions where significant clinical research is happening today? Clinical research in the early 1990s was really in terms of Europe, the US and Japan. That is where we had the ICH and these were the three powerful regions. All the financially significant research was carried out in these areas or at least originated in these areas. Towards the end of the 1990s, we saw an expansion of the work train in clinical trials into what we call the non-ICH regions. And in particular we saw clinical trials starting to develop a little bit in places like South Africa, Argentina, Brazil and then especially in Central and Eastern Europe. Now there is a phenomenal research going on in places like Hungary, Czech Republic, Slovac Republic, Slovania, Bulgaria, Romania, Russia, Ukraine and even as far east as Kazakhstan and also in Turkey. But at the same time we see a lot of clinical studies going on in countries like Singapore now, which is fast becoming the Asian hub to a certain extent, Taiwan, Korea, Hong Kong. And now we see the developments in India and China. How do you view the global dynamics in clinical research in the future? If we look into the future, maybe ten years from now, my guess is that we will see three major regions/countries in the world doing clinical research. These would be the US, India and China. And the great competition would be between Indian and China. Today India may not be a developed nation but is poised to be one, while Europe is developed. Also, Singapore will continue to grow in this area but it has some inherent limitations. What are the significant differences between India and the rest of the developing nations in terms of clinical research? The big difference between India and Eastern Europe like Russia, Ukraine, Bulgaria, Kazakhstan is that they do not have their own pharmaceutical industry although there are a lot of CROs there. They do not have a history of manufacturing as India does, for example, in generics. They do not have their own biotech companies like that in India. And now probably biotech is necessary to have a strong pharma industry. Many countries can generate studies but can they generate their own products and bring them to the market is the big question. India is already able to do that and will be doing it in a much larger way in the future. China will also be able to do so, its biotech industry is developing and its pharma industry will develop too. The big difference between India and China is really the market place. India has a much more open marketplace and a much greater sense of entrepreneurship. I think China is more hindered but there the government is a great facilitator. Now the Chinese government wants to stimulate clinical research and is planning to go the Singapore way. Rolly Dureha canada Nova Scotia's Life Sciences Industry awaits ACOA funding Members of the life sciences industry in Nova Scotia in Canada are anxious to catch the 'Second Wave' of funding that is coming out of the Atlantic Canada Opportunities Agency's (ACOA) Atlantic Investment Partnership (AIP). The announcement of the renewed program, which was made on July 11, 2005 by Joseph McGuire, minister of ACOA, appears to reaffirm the federal government's commitment to supporting innovation in the region. Of the full $708-million announced under AIP, $300 million will go to the Atlantic Innovation Fund (AIF) over the next five years. This fund is designed to increase the region's capacity to carry out leading-edge research and development and commercialize more of the technologies developed in Atlantic Canada. "This is fabulous news," said Marli MacNeil, CEO of BioNova - Nova Scotia's Biotechnology and Life Sciences Industry Association. "ACOA's continuing investment in the creation and commercialization of transformative technologies means researchers and innovative companies will be able to work together to contribute to the region's economic and social well-being." As part of the AIP, the National Research Council (NRC), which is a significant partner in Nova Scotia's life sciences industry, will also get $110 million to develop technology-based clusters in Atlantic Canada. This funding will allow NRC to place increasing focus on assisting with the innovation needs of industries such as the life sciences. Other proponents of AIP such as the Innovative Communities Fund (ICF), Entrepreneurship and Skills Development and Team Canada Atlantic trade missions, are also seen by the life sciences industry as necessary and worthwhile investments. Source: www.bionova.ns.ca china GM cotton: Expert team passes acceptance check The Ministry of Science and Technology of the People's Republic of China (MOST) recently organized a meeting of experts to conduct acceptance check of the "State Base for Transgenic Cotton Pilot Test and Industrialization" in Anyang, Henan Province. The key people from MOST's Department of Rural and Social Development, China Rural Technology Development Center and the Department of Science and Technology of Henan Province and the acceptance expert team were present at the meeting. After listening in earnest to the work report delivered by the leader of the project and field inspection, the expert team, on the basis of adequate discussion and review, believed that the project team had over fulfilled the contract assignment with overall high quality and agreed in consensus to accept the project. The experts remarked that this project will not only set up the state platform for transgenic cotton technical study and industrialization, making major breakthrough in the scale and efficiency of the transgenic technology, but also provide the technological guarantee and facility support for the environmental release of transgenic cotton and pilot test popularization and greatly facilitate industrialization of domestic transgenic and pest-resistant cotton. Source: www.most.gov.cn Germany Germany to fund 24 bio-agri projects The German government is to support research into the safety of genetically modified (GM) plants with ten million euro over the next three years. Some 24 projects will receive the funding, all of which will investigate the effects that GM plants works have on the effectiveness of antibiotics and herbicides. Antibiotic resistance markers are important tools for the development of genetically modified crops. They are used to identify and isolate the gene or genes that have been moved from one plant to a plant that is to be genetically modified. Seven of the projects will address the replacement of antibiotics and herbicide resistance genes. The researchers will seek to develop methods to remove the marker gene after the creation of transgenic plants, or to ensure that it is only present in a specified area of the genome, in order to avoid unwanted side effects. Nine projects will focus on transgenic varieties of maize. Other projects will look into the biological safety of transgenic cereal crops with resistance to fungus, and the impact of growing transgenic potatoes on the quality of the land. Source: www.biotop.de AMERICA Colorado's bioscience industry evolving rapidly Colorado is carrying out an aggressive plan to grow the state's bioscience industry into one of the country's premier bioscience clusters. A central organizing force and unifying voice for the industry is the Colorado BioScience Association (CBSA), a not-for-profit corporation providing services and support for Colorado's growing biosciences industry. CBSA currently enjoys the support of more than 300 member organizations representing both bioscience companies and companies providing key services to the bioscience industry and research institutions in Colorado. The key to Colorado's emerging bioscience prominence is the $4.3-billion Fitzsimons Project on the front range of the Rockies. In the heart of Aurora, Colorado, an incredible development is taking place. The former Fitzsimons Army Medical Center is being transformed into a state-of-the-art, 578-acre integrated life sciences community. The concentration of exceptional talent, vision and extraordinary facilities at Fitzsimons will provide opportunities for collaboration and resource-sharing that will benefit global health care and improve people's lives. Colorado's bioscience industry is predominantly clustered within the Greater Denver region, Fort Collins, Boulder, and Colorado Springs. Three of the Colorado metro areas that make up the Denver Consolidated Metropolitan Statistical Area (CMSA) account for 80 percent of the state's bioscience employment and 73 percent of establishments. Nearly three hundred and fifty bioscience companies have made their home under the gaze of the Rocky Mountains. These companies are conducting cutting-edge research to find cures to diseases such as cancer, heart disease; improve agricultural yields; and develop cleaner, more efficient manufacturing methods. Bioscience firms tend to geographically concentrate around academic health centers and research universities and Colorado's concentration provides a basis for further building a critical mass. Colorado has fostered a healthy partnership between academia and the private sector to speed basic science discoveries into novel treatments for patients. The University of Colorado system is home to significant research centers that support Colorado's biopharmaceutical industry. The Colorado Alliance for Bioengineering is responsible for the coordination of biotech activities among faculty in all universities throughout the state, while the Colorado Bioprocessing Center at the Colorado State University in Fort Collins develops therapeutic compounds and biologics for biotech companies. Two additional factors in the vitality of the biosciences in Colorado are the federal awards to support both basic research activities, and basic innovation grants to small companies pursuing commercial viability of research conducted in both public and private laboratories in the state. Between 1999 and 2002, Colorado biotechnology companies received 984 Small Business Innovation Research Grants (SBIR), ranking 4th in the nation. In 2003-2004, the biosciences industry sectors in the state employed 11,885 workers in four major sectors with an average salary of $61,414. In addition, more than 20,204 additional service sector jobs were generated to support this growing industry for a total employment impact of 32,089 jobs. The state's biosciences and service providers also contributed an estimated $415.7 million in local, state, and federal taxes. Source: CBSA Energy Policy Act to boost biofuels industry The Energy Policy Act cleared on July 29, 2005 by the US Congress for President Bush's signature will improve domestic energy security by setting goals for production of renewable fuels obtained from US agricultural resources. "The measures that President Bush is about to sign into law are a big step towards enhancing our national security by providing incentives for energy produced from renewable agricultural feedstocks," said Jim Greenwood, president and CEO, BIO. "The application of biotechnology in the industrial setting is affecting a paradigm shift in how we produce energy, and this legislation will provide incentives to hurry the future of biofuels. Soon, we could be producing up to 25 percent of our transportation fuel needs by using industrial biotechnology to produce bioethanol, while adding $5 billion to the farm economy," Greenwood observed. In addition to requiring that the amount of renewable fuels â€“ such as ethanol â€“ blended with gasoline increase from 4 billion gallons in 2006 to 7.5 billion gallons in 2012, the Act provides credit for ethanol made from non-traditional feedstocks like wheat straw and corn stover. The Bill provides $200 million yearly until 2015 to update the Biomass Research and Development Act with the goal of rapidly boosting production of bio-based fuels at competitive prices and developing a broad range of bio-based products that replace petroleum-based products. In addition, the Act establishes a reverse auction to spur production of the first billion gallons of ethanol from cellulosic biomass and creation of a bioethanol industry. The Bill also expands the Federal Agency Biobased Procurement Program to all federal contractors and the US Capitol complex and provides loan guarantees for construction of biorefineries. Source: www.bio.org Singapore "Singapore â€“ a location for networking" "The rapidly growing number of companies conducting drug discovery and basic research in Singapore will complement and reinforce our established biomedical sciences manufacturing and clinical research activities. In fact, Singapore is fast becoming the choice Asia Pacific location for scientists to meet and network," said Dr Balaji Sadasivan, Senior Minister of State for Health and Information, Communications and the Arts, Government of Singapore, at the opening ceremony of the Drug Discovery & Development Asia Pacific Congress 2005. The three-day congress which was held in June 2005 featured over 40 internationally- renowned speakers, who gave updates on disease-specific drug discovery, and presented case studies of successful collaborations and lessons. "Growth is the number one driver of partnering for pharma companies. Other key reasons for partnerships are to access critical capabilities, enter new markets, build up critical mass, accelerate R&D and reduce costs. There is a need for partnering worldwide due to globalization of markets, increasing financial pressures, decreasing R&D productivity and decreasing sales force effectiveness," said Dr Harvinder Popli, head-licensing, Ranbaxy Labs, who is based in India. "India is poised to play a major role in the biotech and pharma industries post 2005. We see that the future of the Indian pharmaceutical industry lies in co-marketing and co-promotion, a model that has already succeeded in the US and Europe," he added. Source: www.biomed-singapore.com Africa AfricaBio project on training farmers a success A project to determine the role of biotechnology in smallholder farming during the 2004 -05 maize season was highly successful. Some 636 small-scale farmers, 65 agricultural extension officers and 21 decision makers in six provinces received extensive training on biotechnology and Bt maize. AfricaBio, in collaboration with the National African Farmers' Union (NAFU), Buhle Farmers' Academy at Delmas in Mpumalanga, Cedara Agricultural College in KZN and the Provincial Departments of Agriculture, initiated this project during the 2004-planting season. Six demonstration sites were selected where Bt and conventional maize were planted side by side. The plots were planted with white Bt and conventional maize in November/December 2004 and harvested during June/July 2005. The average yield for the Bt maize was 42.5 percent higher than the conventional crop. "Training farmers is an ongoing process. One training session is not enough and we will certainly repeat the project this coming season by adding more experimental sites in order to reach more farmers," said Prof Jocelyn Webster, executive director of AfricaBio. Source: www.africabio.com Europe EuropaBio sore over Commission's position on patenting The European Association for Bioindustries, EuropaBio, has expressed its disappointment over the failure of the European Commission to take a position on the patenting of human DNA and human stem cells, which were not clarified in the EU Biotechnology Patents Directive. Directive 98/44 entered into force in July 2000 after ten years of debate between the EU institutions. In 2002, the Commission charged a group of experts with clarifying two topics within the Directive: the scope to be conferred to patents on sequences or partial sequences of genes isolated from the human body; and the patentability of human stem cells and of cell lines obtained from them. It was expected that the Commission would propose new guidelines in its second report on the Directive, which was published on July 14. However, the report actually states that, with regard to DNA sequences, "The Commission will continue to monitor whether there are any economic consequences of possible divergences between Member States' legislation." On stem cells, the Commission makes a differentiation between totipotent stem cells, which can develop into a human being, and pluripotent stem cells, which do not have this ability. "In the light of the Commission's analysis, it appears that totipotent stem cells should not be patentable, on grounds of human dignity. There is no immediate answer to the question of the patentability of embryonic pluripotent stem cells and indeed at this stage it would appear premature to come to a definitive conclusion. The Commission will continue to monitor developments in this area," the report states. Source: www.biotop.de BIO hails Dr Crawford's confirmation as FDA chief The Biotechnology Industry Organization (BIO) has welcomed the Senate confirmation of Dr Lester Crawford as Commissioner of the Food and Drug Administration (FDA). In a statement, James C Greenwood, president and CEO of BIO said, "Dr Crawford ably led the agency through a difficult period last year, and we welcome his confirmation as Commissioner. Dr Crawford recognizes that the FDA's role as a regulatory gatekeeper is pivotal to both fostering innovation and ensuring product safety." He further noted, "The FDA must be prepared for innovations emerging from genomics, proteomics, nano technology and other biotechnology applications. We're entering an era of personalized medicine and a revolution with the potential to further tame disabling and deadly diseases. A well-funded, effectively managed FDA is essential to bringing those breakthroughs to patients. FDA is also a key reviewer of biotechnology applications for food and feed to safeguard all foods in the marketplace under the Federal Food Drug and Cosmetic Act. The agency's overview of these products helps to boost consumer confidence at home and abroad. " Source: www.bio.org Rice genome completed The completion of the rice genome has been announced by an international consortium. The publicly available finished sequence is anchored to the genetic map, providing both the linear order of the 37,544 genes and their positions on the 12 rice chromosomes. The map-based characterization of the rice genome already has led to the identification of important genes, such as those which may increase yield and productivity. The completed rice genome may enable agricultural breeders to also address other critical issues in rice cultivation. Messing noted that rice cultivation today creates an enormous environmental burden in terms of the quantities of water and fertilizer required to produce a successful crop. The rice genome is the Rosetta Stone of all the bigger grass genomes. Knowing its sequence will provide instantaneous access to the same genes in the same relative physical position in other grasses and accelerate plant gene discovery in many important crops such as corn and wheat. Source: Rutgers Media Statement ]]> <![CDATA[Techniplast launches Sealsafe cage]]> https://biospectrumindia.com/news/95/7547/techniplast-launches-sealsafe-cage.html https://biospectrumindia.com/news/95/7547/techniplast-launches-sealsafe-cage.html Tue, 23 Aug 2005 17:43:00 +0530 BIOPRODUCT BIOPRODUCT Techniplast launches Sealsafe cage Techniplast, an Italian biomedical research equipment company dealing in a diverse range of animal care products, has launched Sealsafe, an Individually Ventilated Cage (IVC), to protect animals from airborne contamination. IVC features supply of HEPA filtered air through a self-closing valve positioned in the top. The IVC has set the standards by redefining at cage level the well proven air pressure barrier concept. This system is available in four different convenient cage sizes AND is being distributed in India exclusively through Delhi-based Samitek Instruments. For further details, contact: samitek@vsnl.com Pharmalab launches isolator barrier technology Pharmalab has introduced Isolator barrier technology in India by joining hands with Isotech Design, a Canadian company. Isotech isolators, microenvironment and mini-environment systems are claimed to offer a cost-effective solution versus traditional clean rooms to manage sterility, control microorganism and particle contamination and provide containment management. For details contact: rashmi@pharmalab.com Thermo introduces new HPLC Columns Thermo Electron has introduced additional columns in the Hypersil GOLD family, in addition to the C18 columns already available. The new phases include C8, CN (cyano), and PFP, fluorinated chemistry. Hypersil GOLD HPLC and LC/MS columns have gained recognition for providing outstanding peak shape. Based on highly pure silica, Hypersil GOLD columns provide symmetrical peaks, even when analyzing basic compounds that give discernibly poor peak shape on traditional reversed phase columns. Reliable manufacturing processes coupled with advanced bonding technologies produce highly efficient, reliable Hypersil GOLD C8, CN and PFP columns. For details contact: shashin.shah@thermo.com Millipore launches Lynx S2S connector Millipore has announced the availability of its Lynx S2S connector, a single-use device for linking pre-sterilized fluid paths in biopharmaceutical processes. Easy to assemble, it facilitates secure connections in upstream and downstream processes as well as final fill and finish processes. The unique design of the Lynx S2S connector allows the assembly of fluid paths in both classified and non-classified environments. The Lynx S2S connector is available individual sets or in quantities of 12 or 24 non-sterile packs. The Lynx S2S connector is part of Millipore's Mobius line of flexible bioprocessing solutions. For details, visit www.millipore.com/mobius Eppendorf's Biochip for better optimization Eppendorf has a new tool for researchers that enables them to effectively and reliably detect at a very early stage in screening any side effects caused by RNAi molecules in the cell, for example side effects such as proliferation, differentiation or apoptosis. The "DualChip Human RNAi Side Effect" array enables for the first time the simple profiling of interactions and side effects by gene expression analysis. The kit consists of a prefabricated low-density chip with highly specific DNA probes. Data can be evaluated with the user-friendly analysis software that displays the results graphically for quick interpretation by the researcher. Thus, highly reproducible evaluations can be done long before cost-intensive clinical test phases are undertaken. For details contact: santosh.p@eppendorf.co.in RayBiotech launches Cytokine Antibody Array US-based RayBiotech has come out with Cytokine Antibody Array, a protein array system. This system not only measures protein expression levels rather then RNA levels but also speeds up discovery process by conserving precious samples and saving time and money. The Cytokine Antibody Array has potential applications in profiling cytokine expressions, monitoring cytokine or chemokine levels in clinical trials, identifying potential molecular targets for drug development, etc. The cytokine array system is being distributed in India exclusively by Delhi-based Biotech India. For details contact: Info@BiotechIndia.com ]]> <![CDATA["The Rs 100-crore Grant Will Just Be the Seed"]]> https://biospectrumindia.com/news/95/1509/the-rs-100-crore-grant-will-just-be-the-seed.html https://biospectrumindia.com/news/95/1509/the-rs-100-crore-grant-will-just-be-the-seed.html Tue, 23 Aug 2005 12:59:00 +0530 New Page 1 "The Rs 100-crore Grant Will Just Be the Seed" -Prof. P Balaram, director, IISc, Bangalore. The government may have finally realized the need for advanced centers for scientific learning in the country. With a view to give a fillip to the efforts, the Centre even announced a Rs 100-crore grant to the IISc to establish itself as a world-class institute. But Prof Padmanabhan Balaram, director, IISc, feels this is the just the beginning of a long journey towards achieving the goal. Excerpts from an interview with Prof. P Balaram, who took charge as the new director of IISc on July 1, 2005: The Central government has allocated Rs 100 crore to make IISc a world-class university ranked along with Harvard, Cambridge and Stanford. What are your plans and priorities? This Rs 100-crore grant was announced somewhat unexpectedly. We are rather pleased that the government has singled out the institute as the first place to experiment on raising standards dramatically. We have our areas of strengths and weaknesses. That we are very conscious of. Harvard, Cambridge and Stanford, Oxford ... all the major universities of the world are certainly models that one should keep in mind. But it is important to realize that a Rs 100-crore grant alone will not be enough to transform an institution along the lines of those mentioned. IISc is arguably the best institution for research in science and engineering in India. And the question we are asking ourselves now is how do we raise the level of research performance to the highest possible level given the constraints under which any Indian institution works. We work under the constraints of history, under constraints of geographic location and also the environment in which you are located. We are now attempting to start a program of modernization of our laboratories. Our laboratories are very old but we have excellent faculty and students. And they definitely deserve the best labs that money can buy in order to carry out their research. This is not a very easy undertaking in an old institution ... it is easier to build a new institution than to transform an old institution into a completely modernized place. We have begun the process of discussion with our faculty and I hope that in the next few months we would have put together a comprehensive plan of modernization. By modernization I also mean providing special thrust to collaborative programs, to inter-disciplinary research programs and also to new faculty members who will come into the institute. It is the younger faculty who eventually are the ones on whom the institute will really depend on in the future. So we hope that some of this money can be used in this direction.   Do you plan to seek more funds from the Central government for the modernization program? Definitely yes! A Rs 100-crore grant, I think, would really just be the seed of a modernization program. I would estimate that a modernization program in a major institution like this to bring it to world standards might run anywhere between Rs 700-1,000 crore. It is certainly not going to be done in a hurry. But I think in different phases complete modernization of this institution is on the cards. And it would be the right time now, more so because we will be completing 100 years and one might ask what about the next 100. I'm not sure that we have people with the vision of JN Tata around. But I think there is a responsibility to see that all the inputs that we get in this period are used to plan for a long-term realization.   The Institute was established in 1909, after a committee headed by JN Tata proposed its setting up to ''promote original investigations in all branches of learning and to utilize them for the benefit of India''. To what extent has the Institute realized this vision? It is almost a 100 years since JN Tata's vision of an institute was realized. I think JN Tata's vision has been fully realized, in that the institute has in fact been pursuing research and higher education in all branches of science and engineering. And over the past 97 years or so, the institute has contributed greatly to the development of science and technology in India. Many major national programs have benefited enormously from the faculty of the institute and also from students who have gone to work with organizations like the Department of Atomic Energy and other companies. The institute has given birth to other institutions. Homi Bhabha was here before he went on to start TIFR. And more recently, the Jawaharlal Nehru Centre for Advanced Scientific Research began here. We also provided a home for the National Centre for Biological Sciences. The institute has been a very hospitable place for promoting other institutions. So, all of this, one might say, is for the benefit of India.   The world's biggest universities, such as Harvard and the MIT, place great emphasis on their undergraduate programs. Why is it that the IISc does not offer undergraduate courses? When the institute was originally founded, India already had great universities like the ones at Madras (Chennai), Delhi, Calcutta, Banaras and Allahabad-they were all major centers of learning. The institute was founded with the idea of an advanced research institution in mind and not as an undergraduate institution. What has really happened in the last 30 years or so is that the universities have gone into a phase of decline and undergraduate programs in science have lost their importance in most universities in India. There has been a general process of decay in universities, which has been written about by analysts. State universities have had financial troubles. The science courses have become less popular as other areas have become more lucrative. So, much of the discussion on the institute offering undergraduate programs, is of recent origin. IISc has maintained its status as a leading national institution with emphasis on research and post-graduate programs. And now it is very difficult for us to start an undergraduate program because that would require commitment of a different sort on the part of the faculty, infrastructure, space ... we would like to keep large parts of the campus as they are because this is one of the few green areas left in Bangalore. We are sort of hemmed in on all sides by development. We are not on the edge of the city where we can grow. So it is something that we think about from time to time - what can we do for undergraduate science teaching? There is a lot of discussion now on whether the institute should participate in raising the quality of undergraduate science education in India. But we don't have any concrete plans at the moment.   The Centre has okayed a modified Block Grant Scheme (BGS) that will help IISc to receive a matching grant depending on the savings effected in the non-plan expenditure. What is your plan of action? There has been no communication from the government in this regard. So I know nothing more than what I have read in the newspapers. But I don't believe that it would be dramatically be different from what we are because we are still funded by the Ministry of Human Resource Development for all our regular expenditures - plan and non-plan. Roughly, we would probably get about a little less than a Rs 100 crore ... about Rs 85 crore to Rs 90 crore as our regular non-plan grant and we would raise another Rs 8-10 crore on our own resources. And we would raise an equal amount, say, another Rs 100 crore from sponsored projects. Each one of our faculty members actually goes out to get projects to carry out their research. So we get a lot of government grants and have a lot of interaction with the industry, which fetches almost the same amount. This money that we have generated from the industry collaboration is about Rs 8-10 crore, which is only a fraction of our total revenue. In externally sponsored projects, a large amount comes from major government agencies like the DST, DBT, DRDO and ISRO.   P&G entered into a tie-up with IISc for molecular modeling. Are there other strategic alliances in the pipeline? This is a project, which Procter & Gamble has taken up with the faculty members in our chemical engineering department. It is really a sort of research project. I wouldn't call it a strategic alliance because it is a very moderate kind of project of about Rs 45 lakh or so. I think there is more publicity in the newspapers about this project but the publicity is quite out of proportion as we have many such projects. They do come through our Centre for Scientific and Industrial Consultancy and also through our Society for Innovation and Development. And there are probably projects of a larger magnitude than this. How do you think the government can improve our education system at all levels? This is the kind of question that one can't really answer because there have been commissions, committees which have all attempted to provide recipes for improving education at all levels. I am, of course, more comfortable with thinking about higher education rather than primary and secondary education. Collegiate education, may be, and university education. I think one of the reasons why higher education, at least in science, has deteriorated over the years is the gradual divorce of undergraduate education from the universities to colleges and institutions. Today, most universities have no undergraduate programs. Undergraduate programs are only held in constituent colleges. Slowly, even masters degree programs are being held in constituent colleges. And the university itself is becoming an administrative entity. This is something that one needs to sort of address and maybe reverse also. The government has new initiatives. Now there are two new national institutes of scientific research and education that will be set up in Pune and Kolkata. They will have undergraduate and research programs. These institutions should hopefully admit their first batch of students in 2006. But it involves a long process. Government approvals are being obtained. I think there are major issues still to be sorted out, like how will the government set up these institutions: will it be by an Act of Parliament or will there be some other mechanisms. This would be like creating two institutions for science, which would be like the IITs have been for engineering.   IISc does not face any competition within the country. Do you think this will make the Institute complacent? I wouldn't say there is no competition in the country now. In specific areas I think there are institutions that compete with this Institute. But they are in specialized areas. Like in the area of biology, which I am most familiar with, many new institutions have been set up. But they are all small and they are specialized. But they are a challenge for our faculty in our departments related to biology. Whether it is the National Institute of Immunology or the Centre for Cellular and Molecular Biology (CCMB) in Hyderabad or the National Centre for Biological Sciences (NCBS)-they are now both our colleagues and competitors. I would like to really think of them as friendly competition so that the general level of biological research in India will go up as these institutions produce more and more people and do better. So I think it is actually very good for the Institute that other institutions do very well in their specifically chosen areas because they do challenge us and make us do better. But if you take the Institution as a whole, I would like to believe that there is no comparable institution in India. It is nice in one way but it is also dangerous in another as it can make people complacent. But the world has become a very small place now and therefore I don't think we are really comfortable comparing ourselves with other institutions in India. We ought to be and this is what I think the government has challenged us to do by giving the grant. We ought to be comparing ourselves with the best institutions in the world and trying to raise the level of performance. So I don't think complacency is something that is going to be around for long. I'm certainly not complacent and I don't believe that most of my colleagues are complacent. We know that competition is everywhere.   Do you plan to start a biotechnology department? I personally believe in many cases wherever we use the word "biotechnology", it has been used incorrectly. Most of the major universities that we talk about have no department of biotechnology. Because biotechnology is an outcome of the research done in all these departments. It is not really a discipline on its own. It is not an academic pursuit on its own. These academic disciplines feed into the technologies, which we are going to use, which are biological departments.   Namratha Jagtap   ]]> <![CDATA[VC investments in life sciences rise to $2.5 billion]]> https://biospectrumindia.com/news/95/2462/vc-investments-in-life-sciences-rise-to-2-5-billion.html https://biospectrumindia.com/news/95/2462/vc-investments-in-life-sciences-rise-to-2-5-billion.html Sat, 20 Aug 2005 13:22:00 +0530 VC investments in life sciences rise to VC investments in life sciences rise to $2.5 billion According to the PricewaterhouseCoopers, Thomson Venture Economics and National Venture Capital Association MoneyTreeSurvey, the Venture Capitalists (VC) investments in the life sciences sector returned to prominence in the second quarter of 2005. The life sciences sector (biotechnology and medical devices industries, together) bounced back to $1.5 billion invested in 154 companies compared to $1.0 billion invested in 135 companies in Q1 2005. For the first half of 2005, life sciences accounted for 25 percent of all venture investing, in line with its dominant position over the past two years. The software industry continued to be the largest single industry category with 231 companies capturing $1.3 billion, slightly above the prior quarter. During the first half of 2005, software represented 23 percent of all venture capital dollars and 30 percent of all deals, virtually the same proportions as in 2004. According to MoneyTreeSurvey, VCs invested $5.8 billion in 750 companies in the second quarter of 2005. Funding increased over Q1 2005 of $4.9 billion, and approached Q2 2004 of $6.1 billion. For the first half of 2005, investing totaled $10.6 billion, tracking closely to full year 2004 of $21 billion. Over the past two years, quarterly investing ranged from $4.6 billion to $6.1 billion. Biolex Therapeutics acquires LemnaGene Biolex Therapeutics, a protein therapeutics company, announced the acquisition of LemnaGene SA, a privately-held, French start-up biotechnology company researching potential applications of the small, aquatic plant Lemna to produce recombinant proteins. Biolex' patented technology platform, the LEX System, uses Lemna as a transgenic host for the development and manufacture of therapeutic proteins and monoclonal antibodies that are difficult to make (technically or economically) in traditional recombinant expression systems. â€œLast year we acquired Epicyte Pharmaceutical, strengthening our technical capabilities and patent position related to plant-based monoclonal antibody production,â€? said Jan Turek, chief executive officer, Biolex. â€œThe acquisition of LemnaGene represents a further consolidation of relevant protein capabilities and will enhance our position as a leader in this space. It is our belief that Biolex is now becoming the first choice for companies seeking a development partner for complex protein therapeutics reflecting our many recent accomplishments.â€? Invitrogen to acquire BioSource International Invitrogen Corp. has announced the signing of a definitive agreement to acquire publicly held life sciences company Bio- Source International in an all-cash transaction totaling approximately $130 million. â€œThe acquisition of BioSource enables our company to continue its growth in the vital area of proteomics,â€? said Gregory T Lucier, chairman and CEO, Invitrogen Corp. This deal augments Invitrogen's collection of protein and primary antibody products gained through its recent acquisitions of Zymed Laboratories and Caltag Laboratories. Additionally, it bolsters Invitrogen's offerings in both kinase and cytokine assay technologies for research applications and provides the company an opportunity to enter new markets in immunology, oncology and neurodegenerative disease. Teva to acquire Ivax for $7.4 billion TEVA Pharmaceutical Industries Ltd. and IVAX Corp. announced a definitive agreement providing for the acquisition of IVAX by TEVA. Under the terms of the agreement, shares of IVAX common stock will, at the election of the shareholder, be converted into either $26 in cash or 0.8471 TEVA ADRs, subject to proration such that no more than one-half of such elections are for cash and no more than half are for TEVA ADRs. The transaction has a total indicated purchase price of approximately $ 7.4 billion. Israel Makov, president and CEO, TEVA said, â€œIVAX, like TEVA, has been a pioneer in its strategies for globalization and growth. Bringing our two companiestogether will vastly enhance our leadership position in the global generic industry. The combination of our two complementary businesses will allow TEVA to expand and strengthen our global generic and branded businesses with additional products, a deeper pipeline, and a wider presence in new therapeutic areas and growth markets.â€? While TEVA Pharmaceutical Industries Ltd., headquartered in Israel, is among the top 20 pharmaceutical companies and among the largest generic pharmaceutical companies in the world, IVAX Corp., headquartered in Miami, Florida, discovers, develops, manufactures, and markets branded and brand equivalent (generic) pharmaceuticals and veterinary products in the US and internationally. Sosei to acquire Arakis for $187.4 million Sosei Co. Ltd, a leading Japanese biopharmaceutical company with operations in Japan and the UK, has acquired Arakis, a private UK-based biopharmaceutical company. This acquisition brings together two successful product discovery and development companies. The enlarged group will have a broad mid- to late-stage clinical and preclinical pipeline, products with near term revenue generation potential, complementary product discovery capabilities and strengths in Europe and Asia. The transaction will be effected by way of an offer to acquire the whole of the issued and to be issued share capital of Arakis by Sosei for $187.4 million. Commenting on the transaction, Shinichi Tamura, chief executive of Sosei, said, â€œThe transaction represents a major step towards Sosei's strategic vision of becoming a global top 10 biopharmaceutical company.â€? Aptuit to acquire 3 Quintiles business units Aptuit Inc., an emerging company focused on streamlining and supporting the drug development process for biotechnology and pharmaceutical innovators, has signed an agreement to acquire three Quintiles Transnational business units for cash consideration of $125 million. The units will be reorganized into three global business lines-Preclinical Technologies, Pharmaceutical Sciences and Packaging & Logistics. Under the terms of the acquisition, Aptuit and Quintiles will enter into a multi-year agreement to jointly market products and services. â€œAs an integrated organization, these business lines constitutea premier business that will form the foundation for our comprehensive drug development services offering,â€?said Michael A Griffith, CEO, Aptuit. The Quintiles units provide services to 19 of the top 20 drug companies worldwide, as well as many emerging biotechnology and pharmaceutical innovators worldwide. â€œThis is a winning, strategic move for Quintiles that we believe will benefit our customers,â€? said Dennis Gillings, CBE, chairman andCEO, Quintiles. â€œThe commercial agreement will enable Quintiles to continue to make early development services available through the alliance while we grow internally to meet the increasing demand for our services in clinical trials and commercial partnerships.â€? Techne Corp. announces acquisitions Techne Corp. announced that its R&D Systems subsidiary has acquired Fortron Bio Science Inc., a developer and manufacturer of monoclonal and polyclonal antibodies, antigens and other biological reagents. R&D Systems simultaneously acquired BiosPacific Inc., a worldwide supplier of biologics to manufacturers of in vitro diagnostic systems (IVDs) and immunodiagnostic kits. These kits are used globally in both clinical laboratory and point-of-care testing for evidence of cardiovascular disease, cancer, infectious diseases, endocrine, thryroid and fertility disorders, and drugs of abuse. BiosPacific is the primary distribution arm of Fortron. R&D Systems is a leading developer and manufacturer purified cytokines (proteins), antibodies and assay kits, which are sold to biomedical researchers and clinical research laboratories. Tom Oland, president and CEO, Techne Corp. said, â€œIstrongly believe there is potential synergy associated with these acquisitions and our business. Fortron and BiosPacific have earned a reputation as suppliers of high quality reagents to manufacturers of in-vitro diagnostic kits and have established themselves as a key vendor to many of the major diagnostic companies.â€? ]]> <![CDATA[R&D Spending on the Rise]]> https://biospectrumindia.com/news/95/2005/rd-spending-on-the-rise.html https://biospectrumindia.com/news/95/2005/rd-spending-on-the-rise.html Sat, 20 Aug 2005 13:18:00 +0530 R R&D Spending on the Rise Dr Anji Reddy, founder and chairman, Dr Reddy's Labs, said â€œThe trajectory of innovation is unpredictable and there is risk involved to those who undertake this journey. It takes courage and vision to look beyond today's vicissitudes and find hope. But if we don't seize the moment and challenge our capacities we will remain pygmies in this world of giants. The future belongs to those who merely seek opportunity, but to those who create it.â€? This pioneering spirit not only drives the research efforts for drug discovery and development at Discovery Research, a strategic business unit of Dr Reddy's Laboratories Ltd but also at other leading pharmaceutical and biotechnology companies who are looking at entering global market for their products. The Indian pharmaceutical and biotechnology companies have achieved significant milestones in the last few years. These companies have helped India attain self-sufficiency in case of formulations, vaccines and gained global recognition as a producer of low cost high quality vaccines/bulk drugs. In the recent past, leading companies have demonstrated their ability to engage in commercially viable research and development (R&D) activities and grow to be major players in the international market. Now Indian companies are in the new era with the introduction of the IPR regime. Introduction of product patent law would mean that the companies would no longer be allowed to reverse engineer molecules that are under patent protection globally. However, they would still be able to compete in the domestic market for generics, i.e. drugs on which the patent has expired. As a result, the number of product launches in the domestic market would decline. The option left for them would be to either operate in the generics market or invest in R&D and invent new chemical entities and dosage forms so as to achieve growth in the long run. It is also likely that the Indian players who do not have strong R&D capabilities and a diversified product portfolio may become contract manufacturers for other players â€“ local as well as multinational. In the long run, introduction of new products through innovative research or inlicensing agreements would be critical for their growth. R&D expenditure tops Rs 1,500 crore Leading companies like Biocon, Ranbaxy, Dr Reddy's Laboratories, Nicholas Piramal, Lupin and Wockhardt have increased their focus on R&D. The R&D activities at these companies are targeted both at New Drug Development (NDD) as well as Novel Drug Delivery Systems (NDDS). The R&D expenditure of leading Indian pharmaceutical companies has crossed Rs 1,500 crore during 2004. In value terms companies like Ranbaxy and Dr Reddy's Labs led the way in R&D spending. Ranbaxy topped the list with an R&D expenditure of around Rs 331.39 crore during the year ended December 2004 (it follows January-December as financial year) against last year's R&D spent of Rs 238 crore. Dr Reddy's Labs, with R&D expenditure of about Rs 283 crore in 2004-05 against last year's expenditure of Rs 191 crore, followed it. The other leading R&D spenders include Biocon (Rs 27 crore), Cadila Healthcare (Rs 71.1 crore), Lupin (Rs 87 crore), Panacea Biotec (Rs 24 crore), Sun Pharmaceutical (Rs 145.9 crore), Torrent Pharmaceuticals (Rs 51 crore), and Wockhardt (Rs 94 crore). In addition to these, several companies are spending about 5-6 percent of their total sales on R&D activities. BIG R&D SPENDERS Company R&D Spend in Rs Crore Ranbaxy 331 Dr Reddys Labs 283 Sun Pharmaceutical 146 Wockhardt 94 Lupin 87 Cadila Healthcare 71 Torrent Pharmaceuticals 51 Biocon 27 Panacea Biotec 24   With increase in R&D expenditure in terms of setting up new infrastructure facilities and running costs, most of these companies are unable to reap the profits for the year and even recorded fall in revenues. On the contrary to the pharmaceutical companies, most of the biotechnology companies are still engaged in R&D activities depending on government support for funds. Firms on the lookout Dr Reddy's Laboratories Ltd has planned a large number of discoverystage and clinical development stage programs. The research programs at Discovery Research are focused towards developing promising drug candidates in the key therapeutic areas of metabolic disorders and cardiovascular indications. In the second quarter of 2005, its investments in R&D have decreased by 2 percent to Rs 51.5 crore from Rs 52.5 crore in Q1 2005. As a percentage to total revenue, R&D spend was at 9 percent as against 10 percent in Q1 2005. This includes reduction of Rs 7.4 crore under the partnership deal with ICICI Venture. During the quarter, of the total reported R&D spend, the company invested Rs 28.1 crore in drug discovery and specialty compared to Rs 29.6 crore in Q1 2005. However, it has strengthened its war chest to support research and litigation costs incurred by it by formalizing a $56-million (an estimated Rs 245 crore) agreement with ICICI Venture Funds Management Company for the development and commercialization of generic drugs filed in the US in 2004-05 and 2005-06. Dabur Pharma Ltd too is planning to make investments of over Rs 300 crore for expanding its manufacturing capabilities and increasing its R&D activities. It is trying to rope in foreign investors including IFC to invest in the company. IFC is exploring a possible equity investment of $15 million in the company. The proposed investment of Rs 300 crore will be spread over the next three years. While 40 per cent of this would be utilized in expanding manufacturing units, the rest will go towards R&D. On the research front, Dabur is the market leader in oncology formulations and active pharmaceuticals ingredients (API or bulk drugs) in India Nicholas Piramal India Ltd (NPIL), one of the leading pharmaceutical players in the country, has invested about Rs 90 crore in setting up a state of-art R&D facility in Mumbai and is planning to spend Rs 1,215 crore in R&D in the next seven years. NPIL is already working closely with leading institutions like IISc and Anna University for R&D activities. Now it has signed a letter of intent with BioSyntech, a Canadian biotech research company that specializes in the discovery, development and manufacturing of cost-effective and physician-friendly biologic implants for therapeutic delivery and regenerative medicine. NPIL's R&D focus will be on four therapeutic areas-oncology, inflammation, diabetes/metabolic syndrome, infectious diseases, with specific biological targets in each area. Oncology is NPIL's most successful program, with the lead molecule (P276) slated to enter Phase I human clinical trials in first half of 2005. The molecular target for this drug, cyclin-dependent kinase- 4 (Cdk4) belongs to a class of enzymes involved in regulation of the cell cycle and causing enhanced tumor cell proliferation. Having one of the finest R&D centers in the country and driven by a mission to become a research-based international pharmaceutical company, Ranbaxy has built expertise in chemical research, pharmaceutical research, fermentation research as well as Novel Drug Delivery Systems Research (NDDS) and New Drug Discovery Research (NDDR). It is committed to channelise close to 6 percent of its global sales into R&D and are accelerating its initiatives in NDDR and NDDS. It presently has around 8-10 programs in the area of NDDR including two NCEs (New Chemical Entities) that are in the clinical phase of development. The urology molecule, RBx 9841, successfully completed single and multiple safety and tolerance studies in normal volunteers and the Phase-II proof-of-concept (POC) clinical trials will be initiated during this year. The collaborative research program with â€œMedicines for Malaria Ventureâ€? (MMV), Geneva, for the development of Anti-Malarial Drug, RBx 11160, is progressing well. The POC Phase IIA clinical trials have been completed and the results are expected by September 2005. R&D expenditure in the quarter ended June 2005 also increased substantially to $26 million, registering an increase of 105 percent. The surge in spending is attributed to the company's increase in bio-studies for generic filings and an increased number of product filings, worldwide. Dr Brian W Tempest, CEO and managing director, Ranbaxy added, â€œWe have committed ourselves to a series of strategic and investment initiatives that will equip the company favorably to achieve its mission of $2 billion sales by the year 2007.â€? Continuing its effort to strengthen the R&D team, Ranbaxy appointed Dr Pradip K Bhatnagar as Head- New Drug Discovery Research in July this year. Dr Bhatnagar brings with him wide-ranging experience covering the areas of drug discovery and alliance management, from his 23 years of association with GlaxoSmithKline, USA. Biocon, an integrated biotech company, continues to make investment in R&D. Biocon's R&D efforts are directed towards five key domains: recombinant DNA technologies, bioprocess development, fermentation-based small molecules, enzymes and biotransformation and clinical development. Kiran Mazumdar-Shaw, chairman and managing director, Biocon added, â€œR&D investments will be key to our growth. Discovery-led R&D will be the differentiator and transforming R&D from generics to discovery led R&D is a priority at Biocon.â€? R&D has enabled Biocon to develop innovative processes, products and technologies. By pioneering novel ways of collating and managing information and knowledge, Biocon has strengthened and extended its R&D activities to diverse domains. Biocon has recently announced a joint R&D program with North Carolina (USA) based Nobex Corporation for Oral Insulin based on Nobex's proprietary conjugated peptide delivery platform. The two partners expect to file an INDA with USFDA by the end of 2005. The company plans to significantly increase its R&D to support a discovery led research strategy. It believes this approach will deliver superior shareholder value over the medium and long term. Consistent with its stated research strategy, it has made significant progress in its collaborative in-licensed R&D programs viz. h-R3/ cancer vaccines (CIMAB), oral insulin (NOBEX) and human antibodies (VACCINEX). Biocon sees these as rapidly developing into very large global opportunities over the next three to four years. â€œThe goal at Panacea Biotec is to develop value added drug products through concerted research in the fields of drug delivery and discovery in the fields of small molecules, vaccines and biopharmaceuticals,â€? informed Rajesh Jain, joint managing director, Panacea Biotec. With more than 40 research-based products in the market, the company's R&D division was involved in developing 20 new vaccines both in combination and single categories under the â€œeasy immunizationâ€? umbrella. The R&D center is focused on the following activities: formulation design and optimization based on in-vitro and in-vivo studies, pharmacokinetic and pharmacodynamic studies in animals, analytical and bio-analytical method development and validation, stability studies, impurity profiling and synthesis, chemical process development and optimization and manufacturing of clinical trial batches. It is also strengthening its R&D activities in view of the market expansion plans it has undertaken. â€œBy 2007 we would have seven R&D centers with 500 scientists from the present capacity of three R&D centers with about 150 scientists,â€? added Jain. Besides, by 2010 it expects R&D spending to near 10 percent of turnover from the current six per cent. The new R&D centers include: new drug discovery research centre at Mohali in Punjab to develop new chemical entities; biopharmaceutical research centre in New Delhi to churn out novel therapeutics; and global R&D centre at Navi Mumbai to develop advanced drug delivery system based products. Shantha Biotechnics, a pioneer in developing and commercializing a recombinant- DNA based healthcare product in India, used to spend at least 5 percent of its gross revenue on R&D. It is involved in the development of biologicals that are going out of patent, shortly. These products will earn the company the status of a leading generic biopharmaceutical company in the next decade. It has taken up in-house as well as collaborative research projects aimed at developing innovative biopharmaceuticals including vaccines against HCV, HEV and TB and therapeutic antibodies. Torrent Pharmaceuticals Ltd based out of Ahmedabad is currently expanding its R&D facility to cater to the needs of regulated markets. The enhancement in R&D infrastructure and increased focus on R&D will strengthen its product pipeline. It may be noted that the company has received $3 million as license income subsequent to the license agreement entered with Switzerland-based Novartis Pharma AG. The agreement grants global rights of patented AGE (Advanced Glycosylation Endproducts) compound to Novartis and envisages a long term arrangement involving subsequent milestone payments as the molecule passes through various phases of clinical development, regulatory approvals and ultimate commercialization. Currently, the Rs 513 crore Torrent Pharma has seven discovery projects in pipeline-one in cardiovascular, four in metabolic disorders and related complications, one in central nervous system and one in obesity. Torrent Pharma has earmarked Rs 100 crore to double its R&D infrastructure and operations over the next 18 months. GLOBAL BIOTECH R&D PRODUCTIVITY ON THE RISE The productivity of big pharma has been remarkable over the past 25 years. In each of the last 10 years, the pharmaceutical industry has ranked at the top of Fortune.s .most profitable. industry list. But this top ranking has eluded the industry in recent years, during which the productivity of the biotech sector. for many years poor in the aggregate.has strengthened markedly. An emerging distinction between biotech and big pharma is the productivity of R&D. According to Arthur D Levinson, chairman and CEO, Genentech, R&D spending by large pharmaceutical companies has been steadily increasing over time, while the number of new drug approvals (NDAs) coming out of these companies has been decreasing. In 2004, the pharmaceutical industry spent about $50 billion on R&D, compared to $16 billion spent on R&D by publicly traded US biotech companies, and an estimated $20 billion spent by the global biotech industry. In spite of its large R&D expenditures, big pharmas. NDAs have been declining steadily, while biotechs have accounted for an increasing share of NDAs over the past five years. In 2003, the biotech industry hit a milestone when it surpassed big pharma in the number of new drug approvals from the Food and Drug Administration (FDA) in a given year. The trend continued to favor biotech in 2004. In 2005, an estimated 35 new pharmaceutical or biotechnology products with sales potential of at least $150 million each will enter the market. Of these, 20 are expected to be products from biotechnology companies, and will be marketed directly by these companies or in collaboration with pharmaceutical partners. In addition, there are more than 700 compounds from biotech firms at various stages of development, with more than 400 compounds in clinical trials. More than four out of five therapies currently in drug development are founded on biotech discoveries or employ biotech tools.                                                                                                       Source: Ernst & Young   Biotechnology is a thrust area of research at Cadila Pharmaceuticals Ltd (CPL). Over the past few years, it has established a strong R&D base in biotechnology and developed working relations with key R&D institutes in the country for outsourcing of R&D. The R&D team has a demonstrated track record of biotechnology absorption through collaborative research. At CPL, collaborative R&D is being carried out in half a dozen national and international research laboratories like IMTECH, Chandigarh, NII and CBT, New Delhi, ICGEB, New Delhi & Trieste, Italy. Development of rDNA proteins for prophylaxis, therapy and diagnosis, Isolation, purification and characterization of biopolymers from natural sources (proteins, enzymes and carbohydrates) for development of surgical aids, therapeutics and prophylactics, immunodiagnostics development, development of PCR-based gene probe assays, development of polyclonal antibodies for use in passive immunizations (passive vaccines) and immunodiagnostics are some of the R&D focused areas at CPL. Manipal Acunova, promoted by the Manipal Group, is investing Rs 45 crore to position itself as a biotech and clinical research company and branch into stem cell research. In the clinical research space, the company has tieups with Biocon India, Pfizer, and AstraZeneca for cancer drug trials. As a contract research organization, Manipal Acunova will focus on drug discovery work for the bio-pharma companies using basic biology and chemistry route. Cancer and diabetes are its focused areas. Besides it is focusing on stem cell research. For stem cell research, it is setting up facilities designed by Zanders of Germany in Bangalore. Since its inception, Serum Institute of India Ltd, India's leading vaccine manufacturer, relied greatly on its R&D activities. A distinctly separate autonomous body, Serum Institute of India Research Foundation, was instituted with an aim of doing research in the fields of medical sciences and in natural and applied sciences. Instead of focusing on fundamental research, Serum Institute's thrust is on applied research. It used to take up ongoing projects i.e. those in concept or pilot scale technology and then do the R&D on the actual development of the product and scale-up of the product. This is actually supporting Serum Institute to develop very high quality products with higher yields. At Serum about 25 percent of its premises is used for R&D facilities. One can't find an independent R&D facility at Serum Institute. Biotechnology too is Wockhardt's R&D thrust area. Its in-house biotechnology team has succeeded in developing recombinant Erythropoietin. Several other products are under development including interferon alpha 2B and other anti-cancer drugs. In the short term, Wockhardt's R&D is aimed at providing new products in India and technology-based pharmaceutical bulk active and dosage forms for the US, European and other markets. In the longer-term, Wockhardt's R&D strategy is to discover a series of new drugs, especially in the field of anti-infectives, antibiotics and anti-bacterials. Wockhardt has invested Rs 350 crore in recent years on R&D activities. This includes the Rs 30 crore R&D centre at Aurangabad. Wockhardt is investing Rs 125 crore in R&D in 2005, up from Rs 94 crore in 2004. Home to 160 scientists, the Lupin Research Park at Pune near Mumbai, is creating new families of life sciences products and services. The Park houses dedicated prototypes and pilot plants for the development of a range of drugs in several therapeutic segments. R&D at Lupin is organized around three focus areas: generics drug master files (DMFs) for APIs and abbreviated new drug applications (ANDAs) for finished products, new chemical entities (NCE) using the synthetic and herbal routes and noveldrug delivery systems (NDDS). Lupin has increased its R&D spend to 6.9 percent of net sales and also entered into a tie up with Cornerstone BioPharma Inc. for anti-infective products. Similarly at Bharat Biotech International Ltd, R&D is an ongoing process. The R&D team has undertaken projects of immense social and scientific relevance. At Bharat Biotech's labs, the following products are currently in the stage of clinical trails: Rabies, Japanese Encephalitis, epidermal growth factor and malarial vaccine. Bharat Serums and Vaccines Limited (BSV) too has recognized the criticality of R&D and has established in-house R&D capabilities. BSV's R&D team focuses on developing new generation recombinant therapeutics that replaces the traditional plasma products, which are in short supply worldwide due to dependence on human donors. Narayan Kurlkarni with Ch Srinivas Rao         ]]> <![CDATA[BioManufacturing Consolidates]]> https://biospectrumindia.com/news/95/2681/biomanufacturing-consolidates.html https://biospectrumindia.com/news/95/2681/biomanufacturing-consolidates.html Sat, 20 Aug 2005 13:17:00 +0530 BioManufacturing Consolidates BioManufacturing Consolidates While Indian companies are making significant investments to improve and expand their manufacturing facilities in order to enter regulated markets, global players are eyeing India to set up their manufacturing bases in the country. Indian manufacturing matures complying with global standards. Today many companies in India and elsewhere are planning to make significant investments in R&D and manufacturing. â€œBased on the knowledge about the facilities built by biotech companies manufacturing biologicals and the cost of vaccines, a very approximate estimate of the investments made would be of the order of Rs 1,000 crore,â€? said Varaprasad Reddy, managing director, Shantha Biotechnics, Hyderabad. Reddy does not consider the investments made in facilities for manufacturing fermentation based small molecule drugs such as statins, vitamins, anti-cancer agents and antibiotics. According to others in the industry, the Penicillin manufacturing facilities in the country alone have attracted close to Rs 750 crore of investment. And several companies have built manufacturing facilities complying with US FDA and EMEA norms. It is not just the biopharma companies which are building quality facilities. Several other biotech manufacturers like those in the enzymes sector are building newer facilities. CL Rathi, managing director, Advanced Biochemicals Ltd, Mumbai which has been manufacturing and exporting cellulase enzyme for the last nine years, said, â€œWe now manufacture about 1000 MT (metric tons) cellulase enzyme per year. We are also now setting up a 100 percent Export Oriented Unit and are planning to invest over Rs 110 crore at Indore SEZ to manufacture cellulase, alkali protease, amylase, catalase, xylanase, acid and neutral protease enzymes.â€? Rathi added, â€œOur investment in manufacturing has been about $2 million and we are further planning to spend over $25 million in next five years. We also plan to expand our manufacturing knowledge by setting up a plant in China.â€? Similarly, Maps India Ltd, a biotechnology company producing enzymes and microorganisms, has signed a MoU with the government of Gujarat for investing Rs 10 crore for production of new enzymes and microorganisms during the current year. Celestial Labs is investing close to Rs 15 crore to set up an enzymes production unit in Hyderabad. Besides multinationals also are now actively pursuing their plans to have manufacturing facilities in India. On February 22, 2005, Glaxo SmithKline (GSK), commenced work to set up a vaccine filling and packing unit for vaccines intended for India at Nasik. And it is expected to be fully operational by early 2006. S Kalyanasundaram, managing director, GlaxoSmith- Kline Pharmaceuticals Ltd, informed, â€œOur factory is capable of delivering vaccines to all children in the country. That is the capability we are creating at Nasik. GSK is able to manufacture and sell vaccines to the tune of 1.5 billion doses. If you look at the global population with newborn babies of 120 million, even if you assume 80 percent of our 1.5 billion doses goes to children, then every child will probably be consuming 8-10 doses of GSK vaccines. We are not only selling for children but also for adults.â€? GSK is investing approximately $20 million (Rs 88 crore) in setting up its vaccine filling plant. Chiron Behring Vaccines Pvt Ltd, a wholly owned subsidiary of the Chiron Corp., has a manufacturing facility at Ankleshwar in Gujarat. The plant is based at the manufacturing complex of Aventis Pharma another major pharma company in India with which Chiron has a manufacturing agreement. Sigma-Aldrich Corporation, the US-based $1.2-billion leading life sciences and high technology company and German pharmaceuticals and chemicals giant Altana AG are planning to set up facilities at SP Biotech Park, Hyderabad. UK-based Randox Laboratories would set up a diagnostics kit manufacturing unit in Bangalore. India is now emerging as a favored destination for several reasons. Added Reddy, â€œDuring the last two decades, India has emerged as a preferred destination for cost competitive quality production of pharmaceutical API (active pharmaceutical ingredient) and formulations. Today, India enjoys the distinction of having the maximum number of US FDA approved facilities anywhere in the world outside of the US and has proven its claim to be a major manufacturing hub and supply center to the world. With the Indian IPR laws in place, the pharma manufacturing sector is expected to leap.â€? â€œIt is not just a matter of cost arbitrage. Indian biopharmaceutical industry is moving up the value chain. From being a pure reverse engineering industry focused on the domestic market, the industry is moving towards 1basic research driven, export oriented global presence, providing wide range of value added quality products and services,â€? added Kiran Mazumdar-Shaw, chairman and managing director, Biocon. The focus of several Indian companies is to tap global markets and so they have focused on quality. For example, Biocon is now preparing itself to tap the US market for its Pravastatin and Simvastatin and working towards getting its plants FDA approved. Serum Institute has many of its products qualified by WHO. Shantha's Hepatitis B vaccine has been qualified by WHO. Panacea Biotec is in the process of becoming WHO pre qualified supplier of vaccines. Bharat Biotech got the approval from Korean Food and Drugs Administration for its human vaccines manufacturing facility located at Hyderabad. This helps Bharat Biotech to attain a level playing field and help reposition its entry into the global market. It has also signed an agreement with a South African company to set up a vaccine manufacturing plant in that country. It has signed an alliance with Wyeth International for manufacturing Hib vaccines. Bharat Biotech, Biocon, Intas Pharmaceuticals, Shantha Biotechnics, and Wockhardt are some of the companies that are manufacturing rDNA products in India. Others like Glenmark Labs are serious on setting up manufacturing facilities for recombinant biotech products. Haffkine BioPharmaceuticals, Hindustan Antibiotics, Shreya Life Sciences, and US Vitamins have been into formulation business so as to produce for mass consumption. Serum Institute has been investing about Rs 200 crore for expanding its manufacturing facilities at Pune. Biological E, which is looking at increasing its revenue from the biotech area by about 65 percent in the next few years, plans to consolidate its position in vaccine space by increasing the capacity and also by setting up a modern vaccine facility at SP Biotech Park at Hyderabad. It is investing about 36 percent of its sales on infrastructure development. Last year it has invested Rs 35 crore. This year it plans to invest Rs 44 crore again on infrastructure developments. â€œOur capex in the new plant is Rs 95 crore,â€? informed S Swaminathan, vice president (finance), Biological E. Indian Immunologicals Ltd (IIL), a major player in animal vaccines manufacturing, has been making investments in infrastructure development in the last few years. IIL has invested Rs 50 crore last year against Rs 11.74 crore in 2002-03. Venkateshwara Hatcheries, a leading poultry vaccine manufacturer is entering manufacturing human vaccines. Venkateshwara Hatcheries is investing about Rs 180 crore in phases. During first two years it will be investing Rs 60 crore and remaining amount in the subsequent years. It is not alone the private sector that has made investments in manufacturing and upgradation of infrastructure. A public sector undertaking set up by Department of Biotechnology - Bharat Immunologicals and Biologicals Corporation Ltd - had invested Rs 38.9 crore on infrastructure development to formulate 120 million doses of Oral Polio Vaccine. India has the largest number of pharma plants approved by USFDA outside the US. Indian pharma companies have also got certification from the European and Australian drug authorities. USFDA is now looking at opening its office in India. Industry sources say that soon this could become a reality. Commenting on the approvals, Dr Dhananjay Patankar, head - biotechnology, Intas Pharmaceuticals, said, â€œIndian companies can meet the GMP standards. Intas has already received the approval from TGA, Australia and MHRA, UK for bulk drug production. We know the system. It won't be a problem when a company comes out with a new drug.â€? Bipin Deshmane, general manager, Shreya Biotech observed, â€œBesides Shantha only few companies in India are into manufacturing recombinant products. Others procure, formulate and sell in bulk in the domestic market. At present many Indian pharmaceutical formulation plants have received USFDA approvals. Companies such as Lupin, Biocon, JK Pharma, and Ranbaxy got the USFDA approvals for manufacturing few of their fermentation products. And I feel no Indian recombinant DNA product manufacturing company has received USFDA approvals for its manufacturing plant. However, the leading biotech companies including Shreya Biotech are working on aiming to have USFDA approvals so that they can enter the regulated market.â€? Is India an R&D hub and China a manufacturing hub? In a few spaces such as diagnostic kits its true. Indian players find it difficult to face competition from Chinese players in terms of price. China made diagnostic kits are entering the Indian market at lesser price forcing the Indian companies to rethink to enter the same space. Dr SD Ravetkar, senior director, Serum Institute of India Ltd, said, â€œIndia is ahead of China in bio manufacturing. Already Indian companies are exporting vaccines, few recombinant products to third world countries at an affordable price.â€? Expressing his views on few biotech products available in India, Dr Ravet kar said, â€œAlthough there are only a handful of biotech products launched in India, we will see more products in the country in near future as many companies are working on developing indigenous products. It will slowly pick up in the coming years. India has to gear up to launch new biotech products at an affordable price. For this to happen the government has to have a practical single window clearance system. Besides it should also look at faster implementation of Dr RA Mashelkar Committee recommendations. Along with the government, it is the responsibility of the individual companies to catch up with the latest developments taking place in R&D and update their skills and look for newer products so as to leverage on more and larger market. I still feel that biotech is still not happening in India. The mindset of the people should be to focus on quality issues as quality is key factor in biotechnology.â€? While Indian companies are building up the capacities to enter the regulated market, there are some basic issues, which are hindering the growth. If the regulatory framework becomes clear one can see more companies making investments in bio manufacturing facilities in India. Varaprasad Reddy noted that the present regulatory position â€œproduct to processâ€? does not allow choices to the developer to make alteration or change of manufacturing facilities. This stance of USFDA and EMEA is the main issue of contention to allow or not to allow generic biologicals. Hence he felt the government should make an amendment to this position that would open opportunities for contract manufacturers to participate on toll manufacturing contracts for original developer of molecules and for manufacturing and marketing a generic version of the same on the expiry of patents. Yet, contract manufacturing is a lucrative. Alok Gupta, country head, biotech and life Sciences, Yes Bank Ltd remarked, â€œIn biotech space larger biological companies are outsourcing their manufacturing or production part to Indian companies. The tie up between Wyeth International and Bharat Biotech International Ltd for filling facilities of Hib vaccines is an example. Similarly we have Biocon, which has signed a letter of intent to export recombinant human insulin to Bristol Myers Squibb. Hence companies should look at joint ventures/ initiatives to work together to reap profits.â€? â€œWhile there are clearly established 'bio-manufacturing' capabilities these are largely in the area of proteins. We do not as yet have monoclonal antibodies being manufactured in India. The capabilities built up have brought a dramatic fall in product prices. A need for product differentiation is critical. At this point in time there is no clearly established pathway for 'generic' biologics, as is the case for pharmaceutical products. Accordingly access to the regulated markets is therefore not available. Exports are restricted to Africa, South America and some parts of Asia. Contract manufacturing has already commenced and one sees examples thereof in tie-ups such as Wyeth and Bharat Biotech.â€? added Utkarsh Palnitkar, industry leader, health sciences, Ernst & Young. On the other hand Dr Dhananjay Patankar said, â€œThe leading Indian companies in biotech space have realized that they have to enter international market eventually the regulated markets. Hence they are focusing on in house manufacturing facilities. It helps to produce quality products and also make profits by entering the huge global market. About 7-8 companies in India have in house manufacturing facilities for biologicals. As biologicals are specialized products they need regular technical and R&D support. It also supports the growth of research and development (R&D).â€? Globally there is an acute shortage of bio manufacturing capacity. Indian biopharmaceuticals can provide the manufacturing services as it has good manufacturing infrastructure for production of biotech products that would meet the global standards in terms of quality. The government support to the companies interested in setting up manufacturing facilities, by offering incentive package as being offer for R&D activities will be very helpful echoes the industry. Mazumdar Shaw, believes, â€œThe focus will be on indigenous manufacturing of recombinant drugs. In the next few years, the growth will be on account of both indigenous manufacturing and filling contract. A lot of activities are taking place in this front and many more companies will shift to bio manufacturing in the next five years.â€? Ch. Srinivas Rao with Narayan Kulkarni and Rolly Dureha         ]]> <![CDATA[Focus was on creating exchange mechanisms between India and the US]]> https://biospectrumindia.com/news/95/1173/focus-was-on-creating-exchange-mechanisms-between-india-and-the-us.html https://biospectrumindia.com/news/95/1173/focus-was-on-creating-exchange-mechanisms-between-india-and-the-us.html Sat, 20 Aug 2005 13:08:00 +0530 New Page 1 â€œFocus was on creating exchange mechanisms between India and the USâ€? -Dr Amit Mitra, secretary general, FICCI What were the highlights of the FICCI Biotech Industry Delegation to the US during the BIO 2005? The objective of the biotech industry delegation was to encourage the investment, technological tie-ups in the area of biotechnology. During the visit, the US-India Business Council, under the aegis of the United States Department of Commerce and the Government of India, hosted 35 Indian biotech companies and 135 US industry delegates to discuss future collaborations in this field. The purpose of the event was to identify impediments and next steps for both Indian and American companies doing business in the now rapidly expanding two-way high technology trade. The key issues which emerged prominently during our discussions were: Removal of roadblocks to vaccine development and development of protocols to govern the transfers of biological material internationally; streamlining of protocols necessary to conduct clinical trials in India; development of regulatory structure for agriculture that ensures environmental safety; closer cooperation in the realm of human capital through a series of academic, business and governmental partnerships and exchanges between the US and India. The focus was on creating exchange mechanisms between the two countries. There are about eight major deals emerging in the area of vaccines as fallout of the industry delegation visit during BIO 2005. What are the key focus areas for FICCI in biotechnology? In the biotech arena, FICCI has a strong focus in pharma, healthcare and agri sector. A lot can be done in the pharma and agri sector through biotechnology. In the healthcare segment, the way diseases are treated can undergo a fundamental change through the use of biotech techniques. In the agri sector, there is scope for increasing the productivity and quality through biotechnology. Today the biotech revolution has been unleashed and who so ever stands in the way will get wiped out. The biotech bus will be driven by the US as in the case of the information technology sector. India should be an important partner in this revolution and focus on climbing up the value chain. FICCI mounts biotech delegation to China and Taiwan FICCI is organizing a Biotech delegation to China and Taiwan from September 11-21, 2005. Dr. Krishna M Ella, managing director, Bharat Biotech International and chairman, FICCI Biotech National Committee will be leading the delegation. The visit would constitute of business meetings and visits to some well-known research centers and companies doing cutting edge biotech R&D in both countries. Coinciding with the visit, an international high-level conference on bio-economy is being organized by China National Center for Biotechnology development from September13-15 in Beijing, China.   ]]> <![CDATA[GangaGen gets two US patents for its phage-based products]]> https://biospectrumindia.com/news/95/2919/gangagen-gets-two-us-patents-for-its-phage-based-products.html https://biospectrumindia.com/news/95/2919/gangagen-gets-two-us-patents-for-its-phage-based-products.html Sat, 20 Aug 2005 12:50:00 +0530 GangaGen gets two US patents for its phage GangaGen gets two US patents for its phage-based products GangaGen Biotechnologies, a biotechnology company focused on the development of bacteriophage-based products for prevention and treatment of bacterial infections, has received two US patents for its proprietary bacteriophage technologies â€œLysin-Deficient Bacteriophages with Reduced Immunogenicityâ€? and â€œIncapacitated Whole-Cell Immunogenic Compositions.â€? Announcing this at a press conference in Bangalore in the first week of July, Dr Janaki Ramachandran, president, GangaGen Biotechnologies said GangaGen scientists knocked out the phage gene that codes for the Lysin enzyme responsible for breaking down the bacterial wall and produced a Lysin-deficient bacteriophage that kills the bacterial host, undergoes one cycle of replication but remains inside the dead bacterium. â€œLysin-deficient bacteriophage retain their specificity, kill the pathogenic bacterial host rapidly, but do not cause lysis (breakdown of the bacterial cell wall) and are not released into the patient or the environment. Lysin-deficient phages also permit linear dosing like antibiotics,â€? he explained. The second patent is a logical sequel to the first patent. It enables the development of highly effective vaccine to protect against any bacterial infection in man or animals. GangaGen Biotechnologies Pvt Ltd (GBPL) is developing proprietary phage products to treat infections caused by staphylococcus bacteria, including nasal, urinary tract, and pseudomonas aeruginosa infection in burns and wounds. Its Ottawa-based subsidiary GangaGen Life Sciences Inc (GLSI) is developing phage products for control of bacteria that pose a food safety risk to humans as well as bacterial diseases in production and companion animals (pets). GLSI has demonstrated the efficacy and safety of its first phage product for the control of E.coli 0157 in cattle and expects to complete large scale field trials and get regulatory approval for the product next year. GLSI has also entered into a collaboration with Lallemand, a major animal feed distributor in Europe and South America, for developing remedies to control Salmonella infection of poultry and swine. Founded by Dr J Ramachandran in 2000 with an investment of $5 million, GangaGen plans to mobilize another $5 million. Of this, US-based venture capital firm ICF Ventures Pvt Ltd which initially invested $2 million, would pump in another $2 million in the second round of funding, according to Vijay Angadi, managing partner, ICF Ventures. â€œKisan Goshthiâ€? organized by Lucknow Biotech Park The Lucknow Biotech Park organized a â€œKisan Goshthiâ€?, an educational program for farmers recently. The meeting saw the participation of farmers even from the peripheries of the city. At the event, Dr PK Seth, CEO, Lucknow Biotech Park, and Dr HM Bahl, senior deputy director of National Botanical Research Institute, emphasized on the benefits of Jatropha Curcus plants for extracting biodiesel. The farmers were educated on the need and the advantages of biodiesel and appraised about the benefits of Jatropha Curcas viz it can be planted with other plants to bridge the gap between the harvesting time of both crops for monetary benefits; can be grown on land, planted as a fence or at a distance of one meter and the intermediate land in between these plants can be used for growing medicinal herbs like turmeric, ginger, musli, sarpgandha etc. Jatropha does not affect the growth of other plants in the same field. Lucknow Biotech Park enters into new tie-ups The Lucknow Biotech Park has entered into a twin agreement with an upcoming US-based company Clintech Research LLC, New Jersey and IQRA Biotech Services, Lucknow. Dr Sri Prakash Srivastava, a native of Lucknow and educated in Lucknow, now settled in New Jersey, USA is the founder, president and chief executive officer of this organization. The company is drawing up plans to perform clinical trial/operations and pre-clinical regulatory toxicology services to pharmaceutical/biotechnology companies for their new chemical entities and IND. Initially, the company is setting up a wholly owned subsidiary at the Lucknow Biotech Park to manage clinical operations as well as use the existing facilities for pre-clinical regulatory toxicology and bio-efficacy evaluation of the new chemical entities. Subsequently, they plan to set up R&D laboratories of their own for such purpose at the Biotech Park, Lucknow. Dr Syed Ahmad, director of IQRA Biotech Services will be developing the first Human DNA Bank in Asia and identified to be the second globally. At present this technical know-how is only being used by the Federal Bureau of Investigation, USA. The sequence data mode will be programmed through a smart chip device. This technology will be highly applicable at the domestic and international entry points, financial credit sector, judiciary, vehicle licensing authorities and the public distribution system at large. The Biotech Park economy based infrastructure is unfolding global technology at the doorstep. CyberMedia profits up 47 percent in Q1 CyberMedia, publishers of BioSpectrum, has registered a 28 percent increase in income year-on-year (YoY) in Q1 2005-06, with revenues of Rs 151.64 million (Rs 15.16 crore) compared to Rs 118.38 million in Q1 of 2004-05. CyberMedia had its IPO in May and listed on the bourses on June 10, 2005. This is the first quarterly results after listing. The operating profit increased by 49 percent over Q1 in 2004-05 to Rs 19.02 million. The revenues from publishing business increased by 42 percent YoY to Rs 103.25 million. Revenues from research business increased by 51 percent and online business by 83 percent in Q1. "It has been another successful quarter for CyberMedia. Our strategy of focusing on high growth, high margin businesses has started giving positive results with operating margins improving to 13 percent. Also the last quarter has seen us successfully commence our 'content BPO' operations with initial manpower strength of around 90 professionals," said Pradeep Gupta, managing director, CyberMedia. Patents Symposium in Goa The Goa Institute of Management ( GIM), a premier business school located in Goa is organizing ´The Patents Symposium 2005´ on August 20-21 at Panaji. The symposium endeavors to provide a legal and business perspective with the new patent regime and strategies to be adopted for a sustainable and successful future.It will be inaugurated by Atomic Energy Commission (AEC) chairman, Dr Anil Kakodkar. Prominent pharma and biotech industry leaders like Dr K Anji Reddy of Dr Reddy's Lab, Dr Swati Piramal of Nicholas Piramal, Dr Girish Teland of Roche Scientific company, Dr Arno Hartnann, patent expert from Merck, Germany, Pradip Mazumdar of Syngenta are among the participants. Conference organizer Dr Anand Kolwalkar of GIM said the success of Indian companies affected by the strong IPR protection afforded as a consequence of the shift to product patent regime would depend on the strategies they adopt. The future will be determined by how well companies market their products to several regions and distribute risks, their forward and backward integration capabilities, their R&D strength, their consolidation through mergers and acquisitions, co marketing and licensing agreements. The meeting will discuss these issues. Biocon's first quarter revenues at Rs 176 crore Biocon Ltd announced its financial performance for the three months ended June 30, 2005. Biocon group's sales ended at Rs 174 crores matched sales revenues of Q1 FY-2005 as well as the previous quarter. The PAT stood at Rs 39 crore, a decline of 7 percent from the previous quarter and a 20 percent decline from Q1 FY-2005. The decline in PAT was attributed to higher tax charge in the current quarter due to a significant portion of export sales being routed through domestic channels; reduced treasury income of Rs 2 crore commensurate with the deployment of IPO funds in the expansion program. Contract research services from Syngene and Clinigene registered a 35 percent growth over Q1 FY-2005 and matched the previous quarter. Syngene has signed up new contracts during the quarter, which will generate additional revenues in the forthcoming quarters. The strategic partnership with SCIREX, a US-based CRO is also expected to generate additional business for Clinigene this fiscal. "Biocon's new facilities are set to address US Patent expirations of Pravastatin and Simvastatin in mid-2006, which will open up significant opportunities for Biocon starting Q4 FY 2006," informed Kiran Mazumdar-Shaw, chairman and managing director, Biocon. Further Biocon's Pichia based recombinant human insulin, Insugen, is under registration in over 20 countries in Europe, Middle East, Latin America and Asia. "Biocon's discovery led research programs are making good progress: Oral Insulin is on track to file an INDA with USFDA by the end of this year. Biomab, an anti EGFR antibody is in the final stages of Phase II b clinical trials and expects to file for fast track approval in India by the year end," said Mazumdar-Shaw Bharat Biotech launches REGEN-D Hyderabad-based Bharat Biotech International Ltd set a precedent in the arena of diabetic foot care, burn injuries and skin grafts by launching therapeutic, REGEN - D, a recombinant epidermal growth factor (rhEGF). Dr NK Ganguly, director general, Indian Council of Medical Research formally launched the country's first rhEGF, indigenously developed, and manufactured by Bharat Biotech, in Chennai. "REGEN -D is the result of a unique publicprivate technology collaboration. Bharat Biotech has developed this extraordinary therapeutic REGEN -D in collaboration with the Institute of Genomics and Integrated Biology (IGIB), a CSIR institution, New Delhi," remarked Dr Ganguly. REGEN-D is being launched in two strengths -- REGEN - 50 for diabetic foot ulcers and REGEN - 60 for burns and skin grafts. Dr Krishna M Ella, chairman and managing director, Bharat Biotech said, "REGEN -D 150 manufactured indigenously will tremendously impact the lives of a vast patient population in affected with diabetic foot ulcers and REGEN - D 60 has a great role to play in the burns care." Enormous potential for Indian Bioinformatics market: CII The Indian Bioinformatics market, which is only 2.5 percent of the global market, has the potential to capture 5 percent of the global pie, provided the government ushers in necessary changes. According to a report 'Building Blocks of Bioinformatics: Human Resource Requirements In India', prepared by the Confederation of Indian Industry (CII) and the Department of Information Technology (DIT), the future seems very bright for the industry since majority of the Indian Bioinformatics companies are planning to increase their scale of operations. The report states that to capture 5 percent of the global market, the industry would need to grow at a CAGR of 42 percent. Painting a bullish picture, the report states that 42 percent of the sample companies are planning to increase the scale because they are investing more resources in R&D and product development. The report also adds that for expanding the operations, there would be a huge surge in demand for bioinformaticians. According to the report, the total annual manpower required by the industry to achieve a growth rate of 42 percent would be 6484 professionals in 2008-09 and 26362 professionals in 2012-13. Further, the report estimates that nearly 670 teachers would be required in the formal education sector in 2008-09. â€œAssuming a very realistic target for all the institutes by 2012-13, requirements for faculty would rise to 2723â€?, states the report. Merck makes a comeback Merck, one of the world's largest research-driven pharmaceutical companies, has started its second innings in India through MSD Pharmaceuticals, its wholly owned subsidiary unit. Merck Sharp & Dohme Pharmaceuticals commonly known as MSD Pharmaceuticals, kickstarted its operations by introducing and marketing its innovative hospital products and exploring other research opportunities in the country. The US-based company is involved in discovering, developing, manufacturing and marketing a broad range of innovative pharmaceutical products to preserve and improve human health globally and its Indian operations plans to focus on sales and marketing of products and also innovative research down the line. Briefing the media, Leonard Tauro, managing director, MSD India, said that the company would commence its marketing operations by launching two of its life-saving drugs - Zienam, a broad spectrum beta-lactam antibiotic an Aggrastat, a platelet aggregation inhibitor used to treat cardiac complications. The company is looking for marketing tie-ups and alliances with other Indian companies. Panacea Biotec - Q1 Net soars 145% to Rs 21.40 crore Panacea Biotec has recorded a remarkable performance during the quarter ended June 2005 with the turnover during the quarter zooming by 63 percent at Rs160.94 crore as compared to Rs 98.64 crore in the first quarter of previous year. Profit before tax during Q1 has jumped to Rs 32.61 crore as against Rs 13.39 crore during the corresponding period in the previous year. Net profit after tax, is sharply higher at Rs 21.40 crore as compared to Rs 8.74 crore in the corresponding quarter of the previous year. Rajesh Jain, joint managing director, Panacea Biotec, said, â€œThe phenomenal growth in our financials is driven by our novel strategies to position Panacea Biotec as the leading health management companyâ€?. â€œPanacea Biotec is commissioning three research centers in the second half of the current financial year, namely, New Drug Discovery Research Centre at Mohali, Punjab, to develop new chemical entities, Biopharmaceutical Research Centre in New Delhi to churn out novel therapeutics and Global Research & Development centre at Navi Mumbai, to develop advanced drug delivery system based productsâ€?, headded. BioSyntech, Nicholas Piramal ink LoI BioSyntech has signed a Letter of Intent (LoI) with Nicholas Piramal India Limited (NPIL), one of India's leading pharmaceutical companies, pursuant to which NPIL will subscribe to 7,500,000 common shares of the company at a price of C$0.80 per share. NPIL's post-issue shareholding will be approximately 17 percent of issued shares. BioSyntech is a Canada-based biotechnology research company that specializes in the discovery, development and manufacturing of cost-effective and physician-friendly biologic implants for therapeutic delivery and regenerative medicine. BioSyntech specializes in gel-based platforms that are liquid in nature at room temperature and solid at body temperature. The gels are biodegradable, have porous internal structure and enable easy flow of blood nutrients, cells and fluids. These gels are minimally invasive and have controlled residence time. The company's lead products under advanced development are BSTCarGel( R), BST-DermOn and BST-InPod, which are for cartilage regeneration, wound healing activation and fat pad reconstruction for heel pain respectively. BioSyntech has six other products under development for regenerative medicine and therapeutic delivery platforms. As part of the arrangement, NPIL will acquire exclusive rights for marketing, sales and distribution of current and future products of BioSyntech for India, Pakistan, Sri Lanka, Bangladesh, Laos, Cambodia, Vietnam and Philippines. In addition, the companies have agreed to explore opportunities to collaborate for research and development activities with respect to future products of NPIL using BioSyntech's technological platforms. The Letter of Intent provides that for so long as NPIL shall be the registered holder of at least 5,000,000 shares of the company, the board of directors of BioSyntech shall include representatives of NPIL in proportion to its shareholding, subject to a minimum of one director. In addition, NPIL will have proportional pre-emptive rights in the event the company offers further equity securities. This arrangement, which has been approved by the board of both companies, is conditional on satisfactory completion of due diligence, on regulatory approvals and on the signing of definitive agreements. Commenting on this transaction, Claude LeDuc, CEO of BioSyntech said, "We are very excited about this collaboration which brings to BioSyntech significant funding from a committed strategic partner, distribution for its products in South-East Asia and the possibility to joint venture R&D activities in India." Wockhardt Biotech SBU gets 3 more registrations Wockhardt Ltd has reported a 55 percent rise in net profit for the second quarter ended June 30, 2005. Its sales at Rs. 377 crore showed a 29 percent increase over the corresponding quarter of 2004. During the quarter Wockhardt's Biotech SBU received three more registrations for biopharmaceuticals in overseas markets, taking the total registrations received so far to 20. Wockhardt's biotech portfolio grew by 61 percent during the quarter, driven by the robust growth in both Wosulin (recombinant insulin) and Wepox (erythropoietin). Wosulin sales during the quarter showed a 50 percent increase over the first quarter of 2005. Wosulin Pen, India's first automatic insulin delivery device, launched during the quarter, has received a good response from consumers. Wockhardt Biotech Park received good manufacturing practices (GMP) certification for its Wepox facility from the World Health Organization (WHO) during the quarter. Indian presence at the third annual Stem Cell meeting The International Society for Stem Cell Research (ISSCR) held its 3rd annual meeting in San Francisco on June 23-25, 2005. This meeting attracted over 2,000 scientists from around the globe to share research results and talk about future studies. Leading experts working in the stem cell research arena including Ian Wilmut, Jeff Thompson, Irving Weissman, Nobel Laureate Paul Berg and leading professors and clinicians from Stanford, John Hopkins, Harvard, Cambridge University, attended the meeting. There were six posters presentations from India at the meeting. There were two posters each from School of Biotechnology, Guru Gobind Singh Indraprastha University, Delhi and the All India Institute of Medical Sciences, New Delhi and one poster each from Deccan College of Medical Sciences, Hyderabad, and the National Centre of Cell Science, Pune. Dr Krishnamurthy Kannan, professor, School of Biotechnology, Indraprastha Unviersity, who attended the meeting commented, â€œThe conference saw a increased interest towards epigenetics research and how the reprogramming happens at the epigenetic level. Many failures in the area of stem cell are being attributed to incorrect reprogramming at the epigenetic levelâ€?. The meeting showed exciting data from various laboratories and a possible fallout of this visit could be a collaboration with the Stanford Research Center for finding receptors on Ubiquitin for stem cells. Stanford has shown keen interest in this areaâ€?, he added. DaimlerChrysler touches second phase of Jatrophabiodiesel project After putting the vehicles to test in humid conditions, DaimlerChrysler is now testing biodiesel powered Mercedes-Benz cars in frozen climatic conditions After successfully clocking 5,900 km in hot and humid conditions using Jatropha biodiesel, automotive major DaimlerChrysler now plans to test the two C-class Mercedes-Benz cars and an additional Mercedes-Benz Viano across the demanding terrain of Leh and Ladakh. DaimlerChrysler corporate affairs and finance director Suhas Kadlaskar flagged off the cars yesterday that will go to Chandigarh before beginning the 1,920 km journey to Leh. DaimlerChrysler has initiated the ambitious Jatropha Biodiesel program in collaboration with Central Salt and Marin Chemicals Research Institute (CSMCRI) and the University of Hohenheim. As part of its sustainability initiative, DaimlerChrysler has spent over Rs 3.5 crore to develop biodiesel from the Jatropha plants from the wastelands in Gujarat and Orissa. The company began testing the project last year in April when 2 C-Class Mercedes-Benz cars completed a 35-day journey in South, Western India and Delhi. After completing the second phase of testing in cold climatic conditions, a technical feasibility report will be prepared on the project by the end of the year stating that technically biodiesel fuel is the perfect fuel for India. â€œIndia faces difficult challenges. The most pressing is one of pollution. Moreover, the dependability on imports is very high to the tune of 70 per cent. The country has over 130 million hectares lying unused. If this is used to cultivate the Jatropha plant, we could convert challenges to opportunities,â€? said Kadlaskar. DaimlerChrysler is currently running the project on 30 hectares of land in Gujarat and Orissa. The objective is to take the project to a stage of commercial viability. DaimlerChrysler is therefore mooting a village cooperative society concept that would run Jatropha farms generating one to two tons of biodiesel per day. The company is willing to offer a guarantee for the purchase of 50,000 liters of biodiesel fuel from such cooperatives. The company is in the process of finalizing plans for a cooperative in the next two months that would cultivate Jatropha on 500 hectares of land in Gujarat and Orissa. DaimlerChrysler also plans to invest an additional Rs two crore for developing the project. While DaimlerChrysler will take care of the organization, funding and vehicle fleet testing, CSMCRI will implement the project and Hohenheim University will coordinate and evaluate the project. Kadlaskar said UN has expressed an interest in the second phase of the project.â€œShould the second phase of testing be successful, the demonstration project can be upscaled from local plantation to a model for regional, national and international development,â€? Kadlaskar said. - CyberMedia News ]]> <![CDATA[NCBS gets $4 m Japanese funds for joint research programs]]> https://biospectrumindia.com/news/95/2892/ncbs-gets-4-m-japanese-funds-for-joint-research-programs.html https://biospectrumindia.com/news/95/2892/ncbs-gets-4-m-japanese-funds-for-joint-research-programs.html Tue, 16 Aug 2005 18:17:00 +0530 NCBS gets NCBS gets $4 m Japanese funds for joint research programs Prof. Satyajt Mayor The National Center for Biological Sciences (NCBS), Bangalore, has become the first Indian research institution to get funds for joint research programs from the Japan Science and Technology Agency (JST). Prof. Satyajt Mayor of NCBS and Prof. Akhiro Kusumi at the Department of Nanobioprocesses, Kyoto University will take up their joint collaborative project to understand the membrane mechanisms. The five-year research project will get $4 million (Rs 17.2 crore) from JST to enhance the infrastructure and equipments and other facilities needed to conduct the research work. Nearly 30 researchers from both institutions will work on the project. NCBS will spend an equal amount on the research project. Kazuki Okimura, president of JST and Dr VijayRaghavan, director, NCBS, signed the agreement for the project in Bangalore on July 26. JST has so far funded nearly 50 such collaborative research programs globally, but most of them are with big research institutions in the US and Europe. JST has funded five research programs in countries like Malaysia. This is the first-ever funding of a research project with an Indian institution, a member of the five-member Japanese delegation to India said. JST is also planning to fund few more projects with India's Department of Science and Technology (DST), New Delhi. As it plans to increase its engagement with Indian researchers, JST is exploring the possibility of opening an office in New Delhi to coordinate the activities in this country. The JST project with NCBS is an outcome of the recent visit of Japanese Prime Minister Junichiro Koizumi to India. Membrane mechanisms Cells may be a part of biology but the membranes surrounding them have many physical properties. These physical features provide many clues into the biological functions performed by a cell. Dr VijayRaghavan First, if the membrane may be considered as a two-dimensional fluid, this would lead to an enormous enhancement in interactions happening between molecules in the membrane and molecules approaching it from outside or inside the cell. This is simply due to a reduction in dimensionality from 3 (in solution) to 2. Secondly, one can look at the membrane as a liquid mixture which is made up of a variety of molecules that may attract or repel other molecules. These could form different regions of distinct composition, some of which allow particular molecules to come near and others that push other molecules away. This characteristic of a membrane can have dramatic implications for the control of signaling from the exterior of a cell. Third, cell membranes do work closely with the rest of the cell. A study of this relationship would lead to a better understanding of membrane shape, formation of areas which attract or repel other molecules, movement of membrane molecules and other complexes in the domain. The Indo-Japan project has been conceived to examine these ideas and clarify how they may be applicable to fundamental biological problems of signal transduction and trafficking of membrane-associated molecules in cells. Source: NCBS ]]> <![CDATA[EAST BOUND]]> https://biospectrumindia.com/news/95/2782/east-bound.html https://biospectrumindia.com/news/95/2782/east-bound.html Tue, 16 Aug 2005 18:02:00 +0530 EAST BOUND EAST BOUND Orissa After signing a big deal to the tune of $12 billion with Posco in iron and steel sector, the government of Orissa plans to set up two biotech parks in the state. Chief Minister Naveen Patnaik of Orissa, said, "Our government does not believe in mere slogans, but means business". The state is looking at setting up parks at Patrapada near Bhubaneswar along National Highway No. 5 and another one on Konark sea beach near Chandrabhaga. The parks would be aimed at encouraging biotech entrepreneurs and would be established with an initial corpus of about Rs 50 crore. The parks would provide laboratory infrastructure, world-class equipment, training centre and special programs to develop biotechnology industry. The park at Bhubaneswar will come up over an area of 74 acres, next to the medicinal plants garden developed by the state forest department. Similarly, the park to come up at Chandrabhaga will have marine life as its theme and will be set up over an area of 22 acres. The parks are expected to give a fillip to the biotechnology sector. The state government had formulated a draft biotech policy, which would be finalized and implemented soon. The new policy would provide right kind of incentives to investors to make investment in this sector. The policy among other things prioritizes the thrust areas for basic and applied research and technology development, promotes innovation in research and development by providing financial and infrastructure support and by encouraging public-private partnership for research and development and promotes development of the industry by providing quality infrastructure and an enabling environment for sustained growth and international competitiveness. West Bengal In view of the growing importance of the biotechnology industry, the West Bengal government too is interested to have a park to provide the basic infrastructure. IIT Kharagpur is contemplating setting up of a Rs 100-crore biotechnology park in the state. The state has announced a biotech policy in 2002. The park would be located close to IIT's sprawling 22-acre campus. WEST BOUND Gujarat The government of Gujarat proposes to set up a state-of-the-art "Biotech Park" on a public-private partnership model at Savli near Vadodara about 110 km from Ahmedabad. The park will spread across an area of 700 acres (including phase I, II and III). The state government has invited global tenders to rope in a strategic partner for the proposed Rs 100-crore biotech park. The park will be complemented by a Biotech Venture Fund with a corpus of Rs 5 crore to be expanded to Rs 50 crore by the year-end. Gujarat Venture Finance Ltd will mobilize the rest from institutional investors like SIDBI, UTI, banks, corporate entities and high net worth individual. The state government is also considering setting up of a Marine Biotech Park to expand the biotech base. Meanwhile companies like Cadila Healthcare, Synchron Research Services, Concord Biotech, Claris Life Sciences, Maps India, Ban Labs and RPG Life Sciences who have their presence in the state have signed MoUs with the state government for investing about Rs 110 crore in biotechnology space. The proposed Biotech Park at Vadodara will aim to provide an ideal environment for research and development and create centers of excellence that will facilitate investigation, development, production and commercialization of innovative biotechnology products. It will house a world-class institute that will impart biotechnology training and education and focus on building a strong human resource base in biotechnology and thus fuel the growth of the biotech industry in the state. The park will offer modular laboratory units and plots of varying areas. The park will be designed to suit the requirements of both large companies as well as budding entrepreneurs. It will offer a range of business and administrative support services to the tenants. The park will also act as a host to companies willing to set up a contract research facility and will extend benefits to them in the form of infrastructure and fiscal incentives. Maharashtra In addition to the International Biotech Park at Pune, the government of Maharashtra is developing an agri biotechnology park at Jalna near Aurangabad. The Jalna Agri Biotech Park will focus on agriculture-based biotechnology with focus on gene discovery, bioremediation, fermentation technology, post harvest technology, bioinformatics and diagnostics. The Maharashtra Industrial Development Corporation (MIDC) has signed a MoU with Mahyco Research Foundation to develop the park on an area of 100 acres. This park will give a tremendous boost to the Biotechnology sector in the backward area of Marathvada. NORTH BOUND Chattisgarh Like other states, Chattisgarh too is interested in entering the biotech space. Biotechnology has been identified as a thrust sector in the state's Industrial Policy. The state has drafted a detailed biodiversity plan. And it envisages setting up of a network of bio parks. The state has planned to create ex situ bio parks in identified areas with provision of high quality infrastructure at competitive rates along with relevant integrated services to biotech manufacturing units. It is proposed to provide one-stop services such as database on human resource availability, networking with academic centers of research and industry. The focus of these parks would be on biotechnology industries of relevance to agriculture, horticulture, animal husbandry, forestry and environment protection. Agri-biotechnology would have rice research, vegetables and tubers as the thrust areas. The state would also encourage the development of sericulture, oilseeds and fisheries. It has announced many incentives package for biotechnology industry and the state aims to promote technology and knowledge. Haryana Like the above-mentioned states, Haryana too is interested in developing biotechnology in the state. It released its state biotechnology policy in 2002, wherein it announced a series of incentives for the biotechnology industry. The Haryana government is planning to develop a 50-acre biotechnology park at Manesar. The focus of the park will be on agriculture and pharma/healthcare. Himachal Pradesh The Himachal Pradesh government has a mission to convert the state into a "Herbal Biobusiness Valley" of India. The state has formulated its biotech policy and has identified Agri-Horti-Herbal biotechnology as priority biobusiness areas. In the second phase, it will take up biobusiness activities relating to human and animal health care. Its strengths lie in its biodiversity, eco diversity, and pollution-free environment, availability of adequate land, water and electricity, R&D backing and government facilitation. The state is keen on setting up a biotechnology park on 134 acres of land (first phase) with total investment (incubator and industrial cluster) likely to be in excess of Rs 200 crore on a public- private partnership model. The park will be located near the Horticulture University in Solan. It is estimated that the incubator, spread on an area of 25 acre, would cost about Rs 38.66 crore. The Government of India will be investing Rs 9 crore and the state government will be contributing Rs 7.54 crore towards equipment and core infrastructure in the incubator. The selected private partner will pitch in with the rest of the money. In this context, a tripartite agreement has been signed between the DBT, Government of Himachal Pradesh and the BioBusiness Society formed in the first half of this year. The project management committee has also been formed and soon it will be finalizing a private partner, who will set up, manage and operate the park. The park will provide impetus to bioresource-based ventures leveraging the rich eco and biodiversity of the state. Himachal Pradesh is also planning to develop another biotechnology park near the agricultural university at Palampur once the park at Solan is fully functional. The state government is facilitating the development of the biotech industry through a series of incentives like: 100 percent sales tax exemption on biotech products, 100 percent excise duty exemption for 10 years, income tax exemption for the first five years and 30 percent rebate, thereafter CST and GST incentives and also single window clearance facilities. Madhya Pradesh The Government of Madhya Pradesh wants to create an environment conducive for the application of biotechnological tools and the state announced a policy framework in 2003. Under this framework while all incentives and concessions available to large, medium and small-scale industry would be made available to biotechnology units, package of additional fiscal and non-fiscal incentives were also considered. In addition to these, integrated biotechnology parks would be set up in the state. The state is considering setting up a biotech park at 167 acres of land in Indore at an estimated cost of Rs 61.5 crore. Each park will have a Business Facilitation Center that will, with the help of a single window clearance facility, cover all regulatory aspects and extend help for obtaining power, communication, water supply and waste disposal services. To translate the salient features of the biotechnology policy into action, the state has a set of strategic initiatives such as setting up of a world class Institute of Life Sciences and Technology, at Bhopal with an adjunct biotechnology park for setting up an incubation center, research laboratories and manufacturing units; establishing a biotechnology park, as part of the Special Economic Zone at Indore, with emphasis on agri-biotechnology and pharma-biotechnology units; setting up bio-centers at selected farms of the state agriculture department, State Seeds Corporation and the Krishi Vigyan Kendras of the Agriculture University etc. Punjab Punjab will have a biotechnology park at Derabassi near Chandigarh spread over an area of 100 acres of land at a cost of about Rs 126 crore. It will have facilities to test and certify agro-processed food and medicinal and aromatic plant oils, a benchmark essential for experts of these projects to other countries. The facility is expected to boost exports from the other north Indian states. The Punjab State Council for Science and Technology (PSCST), the nodal agency for promotion of biotechnology sector in the state, jointly with the private partner, Beckons Industries, has set up a company â€“ Punjab Biotechnology Park Ltd (PBPL) to develop and promote the park. The park will be focusing broadly on the agriculture, pharma/healthcare, energy, environment and industrial segments. The park will have incubator facility to offer enterprise development support to the biotechnology industry. In the agricultural segment, the PSCST is developing an incubator facility for "testing and certification of agro products" and common extraction facility for medicinal and aromatic plants. The DBT and the Government of Punjab are supporting this facility. The DBT has pledged support of Rs 7 crore and the Government of Punjab will be investing about Rs 3.5 crore for the incubator. The facility will be set up on the 27-acre land, which has been acquired. This incubator is expected to be functional during 2005-06. In addition, the bio inputs area-biofertilizers, biopesticides and growth hormones is being actively looked into. In the pharma/healthcare arena, the focus will be on manufacturing of essential free fatty acids. PBPL has signed an MoU with AgBioWest Inc, Canada and Bioriginal Food and Science Corporation, Saskatchewan, Canada for R&D and manufacturing of essential free fatty acids in the park. The cost of this project is estimated at Rs 36 crore. For the infrastructure development of the incubator, an agreement with UMA Engineering has been signed. Deloitte and Touche, a global consultant, has been appointed to prepare a feasibility report for the Canadian companies on the availability of raw material and setting up of a facility in the park. This is expected to attract many Canadian companies, which will come to the park for outsourcing services. The manufacturing of nutraceuticals, cosmoceuticals and biomolecules based on new drug discovery research are some other potential areas of interest. The Punjab government has also submitted a project worth Rs 150 crore to the Union Government to set up a National Institute of Biotechnology in the state. For this the state is eager to acquire 300 acres of land at a short distance from Chandigarh. Even the Centre is keen on providing Rs 80 crore for the project. Besides setting up infrastructure in the form of parks, the state government is keen on enhancing research activities in the state. Punjab has signed a memorandum of understanding (MoU) with the Canadian province of Saskatchewan for co-operation in the field of biotechnology. Rajasthan To attract investment in biotechnology sector, the Rajasthan State Industrial Development & Investment Corporation (RIICO), an autonomous semi government body, is considering developing state-of-art biotech parks at Jaipur, Jodhpur and Bhiwadi (Alwar). The park at Sitapura, Jaipur is spread over an area of 30 acres on the Jaipur-Kota national highway. About 27 plots have been developed in the park. The dimension of the plots range from 700 sq mts to 20,000 sq mts. In Boranada near Jodhpur, about 22 plots have been developed in an area of 30 acres. The dimension of the plots range from 1500 sq mts to 20,000 sq mts. The 30-acre park at Chopanki, which is about 5 kms from Bhiwadi, has 14 developed plots. All the three parks have the basic infrastructure like earth station (for high speed data com facility), power, telecom, roads, etc. The state government has announced its investor friendly biotechnology policy in 2004, which offered 100 percent exemption from stamp duty for registration of land in designated RIICO Biotech parks. Uttar Pradesh A late entrant in this field, the government of Uttar Pradesh has declared incentives and concessions to promote biotechnology industry in the state. The incentives include establishment of a Rs 50-crore venture capital fund / seed capital fund for research-based industries, 100 percent stamp duty exemption on biotechnology units, entry tax exemption for fifteen years on capital goods including captive generation sets, 15 percent subsidy on capital investments to the maximum limit of Rs 30 lakh admissible to new biotech units and expansion of existing units. Although it started a little late, it is catching up fast in attracting the biotech companies both local and international to the Biotech Park, Lucknow. In addition to Lucknow, the state is also looking at the National Capital Region (NCR) comprising the capital city of New Delhi, the industrial suburbs of Gurgaon in the southwest in Haryana, the New Okhla Industrial Development Authority (NOIDA) region in the southeast in Uttar Pradesh â€“ a home to major pharmaceutical and biotechnology units to establish a biotech park. The NCR region has good scope for exploiting potential in the biotech area by pooling state's biodiversity resources and making companies globally competitive. About 185 acres of land has been earmarked at Sector SDZ-6 for a proposed project near the east bank of Yamuna river. The Biotech city at NOIDA would pool the existing biodiversity resources in the state and also help local companies aiming to become globally competitive. The Biotech City is envisaged to comprise a Bio-Service Centre and Incubation facilities. The Bio-Service Centre would house facilities and services like state-of-the art R&D laboratories where entrepreneurs can engage in production and research activities. Individual premises are offered on lease / rental basis for the development / production of high-value products. The incubation facilities shall allow smaller firms to carry out R&D activities in a shared environment with less capital investment. The Biotech Consortium India Ltd is acting as strategic adviser to NOIDA for developing the Biotech Park. NOIDA proposes to develop the Biotech City with private sector participation and is in the process of selecting a Developer for the above said Biotech City. Bids from private bidders are invited for development of Biotech City at NOIDA. Uttaranchal Uttaranchal, known for its vast and rich diversity of flora and fauna with two third of its landmass under forest cover, is making efforts to establish an Institute of Bio-Technology. Rare species of plants and animals are also found in the state. Hence biotech is its obvious choice for its socio-economic growth. The state has signed a MoU with Rabo India Finance Company, Infrastructure Development Finance Company and the G B Pant University of Agriculture and Technology in order to forge strategic cooperation to jointly pursue initiatives in the sphere of research in food and agriculture sectors. The government, with its state biotech policy in place since 2004, has proposed to set up a biotechnology park in Haldi, Pantnagar in association with the private sector. About 1000 acres of land in the GB Pant University of Agriculture and Technology has been earmarked for this purpose, which will be developed in a phased manner. The park will focus on plant biotechnology in a big way and will leverage the scientific skills of the university. The proposed park will integrate resources and provide amongst others, a focused institutional set-up for accelerated commercial growth of biotechnology and bio-informatics. A project advisor for the Pantnagar Biotech Park will be appointed shortly to facilitate the speedy development of the park. SOUTH BOUND Karnataka Karnataka is a leading state in biotechnology and its capital Bangalore, Indian IT capital, is a biotech hub of the country. As envisaged in its Millennium Biotech Policy announced in 2001, the Government of Karnataka proposes to set up a biotech park in Bangalore (called Bangalore Helix) that meets global biotech guidelines. The proposed park would have an infrastructure that would not only foster the growth of the biotech sector and create employment, but also help in bringing India to the center stage of global biotechnology business. The Biotech Incubation and Common Instrumentation Facility in the Bangalore Biotech Park would work towards promoting entrepreneurship, facilitate in academicâ€“industry collaboration, single window approval processes, attraction for FDI, catalyst for local development and employment, etc. At present, about 90 acres of land in the Electronic City of Bangalore has been in possession by the Department of IT & Biotechnology, the Government of Karnataka and an additional 14 acres is in the process of being transferred to the department, thus totaling to an area of 104 acres. It is proposed to set up the biotech park under public/private partnership model. The support infrastructure facilities and business centre would be developed and managed by the project company (Private Partner). The state government has called for technical bids from builders, and has received expression of interest (EoI) from several real estate players for developing the park. According to M K Shankaralinge Gowda, Secretary of the IT & BT Department, "The architect consultant for the park Jurong Consultants has signed up with Department, and the process of selection of principal contractor for the development of the institutional and R&D Block in the park is under the final stage of selection and once this is done all the major work will take off." Biotech Incubation and Common Facilities Centre would come up in an area of about 10-15 acres in the biotech park. IBAB, an apex Institution for Bioinformatics and Biotechnology, and the Centre for Human Genetics would be established in an area of about 10 acres in the biotech park. "The park would also house a Common Effluent Treatment Plant (CETP)," added Gowda. Kerala God's own country, Kerala, is also keen on developing and promoting biotech industry using its own resources by setting up biotech parks. The Kerala Industrial Infrastructure Development Corporation (Kinfra) has earmarked 50 acres of land at Kalamassery near Kochi for setting up the biotechnology park with financial assistance from the DBT and the state government. The park would be a combination of a Technology Incubation Centre (TIC) providing modules for R&D in biotechnology, pilot plant and a business enterprise zone (BEZ) comprising developed plots to be utilized for setting up of industrial units. The state chief minister, Oommen Chandy laid the foundation stone for project in May 2005. The total cost for developing the park is estimated at Rs 39.54 crore. The cost of the incubation centre will be estimated at Rs 23.19 crore. The Government of India has sanctioned Rs 11 crore for the establishment of a biotechnology incubator at the park. The incubation centre will cover an area of 1,000 square feet and will have 10 workspaces for biotechnology entrepreneurs. The centre will function as an autonomous society formed jointly by the DBT, the Government of Kerala and Kinfra. In addition to this, Kinfra proposed to develop another park at Trivandrum. The Trivandrum Park would be located on 25 acres of developed land available at Kinfra Apparel Park premises at Thumba. Research institutions like Rajiv Gandhi Center for Biotechnology, Tropical Botanical Garden & Research Institute, Kerala Agricultural University, Central Tuber Crops Research Institute are located in Trivandrum. Thrust sectors of the parks include immuno-diagnostics and vaccines in the health care sector, biopesticides, biofertilizers tissue culture and extraction of medical plants in the agri biotech sector and enzymes in the industrial biotech sector. Narayan Kulkarni with inputs from Rolly Dureha in Delhi and Srinivas Rao in Bangalore ]]> <![CDATA[Upcoming Biotech Parks]]> https://biospectrumindia.com/news/95/6479/upcoming-biotech-parks.html https://biospectrumindia.com/news/95/6479/upcoming-biotech-parks.html Tue, 16 Aug 2005 17:53:00 +0530 Upcoming Biotech Parks Upcoming Biotech Parks The Central and State governments are keen to replicate the success of IT in biotechnology. As a result of this, India will have at least 20 biotech parks in the next few years. Four cities, Chennai, Hyderabad, Lucknow and Pune have taken the lead to develop biotechnology through a concerted and cohesive approach, setting up dedicated parks. These parks have reached a certain level of maturity and their success has driven many other state governments to launch their own biotech parks. Several of these states had earlier encouraged setting up Software Technology Parks of India (STPI) to promote Information Technology in their respective regions and now wish to replicate that success in biotechnology with some financial support from the Center. About 15 states have announced their intention to develop biotech parks. Those who have firmed up their plans include: Andhra Pradesh, Karnataka, Kerala, and Tamil Nadu in the South; Gujarat and Maharashtra in the West; Chandigarh, Haryana, Himachal Pradesh, Madhya Pradesh, Punjab, Rajasthan, Uttar Pradesh and Uttaranchal in the North; and Orissa and West Bengal in the East.  Status of the biotech parks in different states State Park/ Area Project Cost Focus Policy Location (in Acres) (Rs crore) (Year) South           Andhra Shapoorji Pallonji Biotech Park, 140* 400 Biopharma  2001 Pradesh Hyderabad Marine Biotech Park, 218 Marine 2001 Visakhapatnam Agri Biotech Park, 200 Agriculture  2001 Patancheru, Hyderabad ICICI Knowledge Park,  200 50 Pharma/biotech 2001 Hyderabad Tamil Nadu TICEL BioPark, 5 62.5 Biotech 2001 Taramani, Chennai Golden Jubilee Biotech Park 20 Agri biotech 2001 for Women Society, Chennai Kerala Kinfra Biotech Park, 50 39.54 Agri/pharma/ 2003 Kalamassery, Kochi industrial biotech Kinfra Bio Park, Trivandrum 25 Agri/pharma 2003 industrial biotech Karnataka Bangalore Helix, 104 Biotech 2001 Electronic city, Bangalore West           Maharashtra International Biotech Park,  103 250 Biopharma 2001 Hinjawadi, Pune Biotech Park, 100 Agri biotech 2001 Jalna, Aurangabad Gujarat Biotech Park, 100 100 Biotech 2005 Savli, Vadodara North           Madhya Herbal Pharma Park, 167 61.5 Agri, biopharma 2003 Pradesh Betma near Indore Punjab Biotech Park, 100 126 Agri/biopharma/ 2003 Dera Bassi, Chandigarh industrial biotech Himachal Biotech Park, Solan 134 200 Horti/agri/herbal 2001 Pradesh industrial biotech Haryana Biotech Park, Manesar 50 Agri/healthcare 2002 Uttaranchal Pantnagar Biotech Park, Haldi 1000 Agri/healthcare 2004 Uttar Pradesh Biotech Park, Lucknow 8 Agri/healthcare 2004 Rajasthan Biotech Park, Sitapur, Jaipur 30 Biotech 2004 Biotech Park, Boranda, Jodhpur 30 Biotech 2004 Biotech Park, Bhiwda 30 Biotech 2004 East           Orissa Biotech Park,   74 50 Agri/healthcare  No Patrapada, Bhubaneswar Biotech Park,  22 Marine Konark, Chandrabhaga    Note * first phase work completed, state allotted 160 acres for second and 120 - for third phase Several states have more than one biotech parks in their areas. Kerala is considering setting up two parks. Utilizing the rich natural marine resources, Tamil Nadu and Andhra Pradesh are setting up marine biotech parks besides biotech parks at Chennai and Hyderabad respectively. With already one park in Pune, Maharashtra has decided to have another park for agriculture at Aurangabad, the seed capital of India. Karnataka is looking at establishing a biotech park in Bangalore. Gujarat, a base for pharmaceutical companies, is developing a park at Vadodara. States like Haryana, Himachal Pradesh, Madhya Pradesh, Orissa, Punjab, Rajasthan, Uttar Pradesh, Uttaranchal, and West Bengal are eager to leverage on agriculture, horticulture and their biodiversities. All these states are interested in establishing biotechnology parks for the development of the state and also for creating more job opportunities. In the next two-three years, India will have close to 23 parks. Why the sudden rush? A place for Kiran Mazumdar-Shaw, chairman and managing director, Biocon Ltd, in the 10-member team of Indian CEOs, which was part of the delegation to the US led by Indian Prime Minister Dr Manmohan Singh explains the Central government's concern and commitment towards the sunrise biotechnology industry. The government is eager to replicate the success of IT in biotechnology too by providing all possible support. The Government of India through the Department of Biotechnology (DBT) has been supporting this technology-driven industry. During 9th and 10th Plan period, the DBT supported various projects for development of Biovillage and establishment of an all-women Biotech Park in the country to sensitize the industry as well as to bring the proven technologies to the grassroot level. As a result, many state governments are now formulating proposals particularly for establishing biotechnology parks/knowledge parks, biotechnology incubators and pilot plant facilities. The DBT has been extending financial and logistic support for the establishment of biotechnology parks, biotechnology incubators, training and pilot projects in various states. Besides, it is offering the technical support for identification, implementation and review of the projects announced by various states. The DBT has announced a 25 percent increase in its budgetary allocation towards assistance for technology incubators, pilot projects, biotechnology parks and biotech development fund for the year 2005-06, earmarking Rs 25 crore for the same. Considering these factors, the state governments have announced state biotechnology policies. Some of them have also hired private companies like Ernst & Young, Panacea International, Yes Bank, Rabo India and Biotech Consortium India Ltd to support them in identifying suitable developers and promoters for the park and devise a marketing strategy. In addition to the state governments approach for creating conducive environment for early biotech players, the DBT in its National Biotechnology Development Strategy report also noted its intention to promote and support at least 10 biotech parks by 2010. Each park will necessarily meet the qualifying criteria related to the characteristics of the location, a viable business plan, management strategy and a clear definition of the partners and their roles. The DBT will support creation of incubators in biotech parks promoted by a private industry or through public-private partnership in the form of grant up to 30 percent of the total cost or up to 49 percent in the form of equity. It is also proposed to set up a central body, Biotechnology Parks Society of India (BPSI) for the promotion of biotechnology parks in the country on the lines of the Software technology Parks of India (STPI). The BPSI should be run by professionals having experience in the areas of biotechnology, knowledge in Acts and Rules relevant to biotechnology and management skills. The existing parks can become members of these new biotech parks. The BPSI would be responsible for evaluating the project proposals and advising the DBT on the funding pattern; facilitating industries in obtaining industrial, environmental and other relevant approvals from the Central government; making recommendation regarding fiscal incentives to be granted to the biotechnology parks; providing guidance to the venture capital institutions on investment in biotech parks; providing accreditation to the parks etc. Concessions to biotech companies located in biotech parks include benefits as per the recent changes in the Foreign Trade Policy: Duty free import of equipment, instruments and consumables and Tax holiday under Section 10A/ 10B of the Income Tax Act. The DBT is looking at a scheme for operationalizing the incentives to biotech units located in the parks. As part of this scheme, biotech companies located in biotech parks to be allowed a five-year time frame to meet the export obligation norms under the SEZ scheme. This measure helps to address the long and unpredictable gestational time lines that are inherent to biotech product development. With all these proposed initiatives from both the Central and state governments and publicâ€“public and publicâ€“private partnership, the biotechnology industry in India will reach new heights. ]]> <![CDATA[Biotech Parks of India]]> https://biospectrumindia.com/news/95/7669/biotech-parks-of-india.html https://biospectrumindia.com/news/95/7669/biotech-parks-of-india.html Tue, 16 Aug 2005 17:39:00 +0530 There are already over five parks in the country to house biotech and life sciences companies and another five are expected to come up There are already over five parks in the country to house biotech and life sciences companies and another five are expected to come up in the next couple of years. With biotechnology industry registering over 35 percent growth in the last few years, this industry is seen as one of the key attributes that will contribute to the socio-economic growth of the state. So several states are making conscious efforts to create a conducive environment to attract entrepreneurs to set up their units and leverage on the vast talent pool and rich biodiversities in the respective states. Even the Government of India has been supporting this industry since 1986 by establishing a strong network of research institutes and developing academic institutes to fulfill the human resources requirement. Karnataka was the first state in the country to announce a "millennium" biotechnology policy as early as 2001 to promote this sunrise industry. And Maharashtra, Tamil Nadu, Himachal Pradesh and Andhra Pradesh followed it with their own biotechnology policies during the year. Later other states like Haryana (2002), Punjab, Kerala, Madhya Pradesh (2003), and Uttaranchal, Uttar Pradesh, Rajasthan (2004) joined the bandwagon by announcing their respective state policies. The latest to announce the policy initiatives was Gujarat. These announcements have given a push to the development and promotion of biotechnology in the states. One of the salient features of these biotech policies is setting up of dedicated biotech parks. Today there are about half-a-dozen biotech parks in the country and several more are expected to come up in the next two-three years. Shapoorji Pallonji Biotech Park Though Karnataka was the first to announce a Biotech plan for the state, it was Andhra Pradesh, which seized the opportunity. The Andhra Pradesh government was able to put its act together to identify and develop the facilities for biotech entrepreneurs. It entered into a publicâ€“private partnership with Shapoorji Pallonji & Co Ltd with 11 percent equity stake and incorporated Shapoorji Pallonji (SP) Biotech Park Pvt Ltd (SP Biotech Park) for developing and managing the Park at Shamirpet, near Hyderabad. The Park has entered into the second phase of development. The first phase of the park comprised 140 acres of space. About 17 companies have already taken the position and have set up their units at the Park making an investment of about Rs 400 crore. "We are now developing the layout of Phase II of the Park which is 162 acres and the bookings are expected to be over by the end of this year," said S Dhawan, chief executive, Shapoorji Pallonji Biotech Park Pvt Ltd. Considering the demand, Shapoorji Pallonji & Co. has approached the state government for more space for expansion of the park. It is expected to get an additional 100 acres of land for expansion of the biotech park in the third phase. "Another 101 acres is being allotted to start the third phase of the Shapoorji Pallonji Biotech Park and 100 acres for the Rs 125 crore National Animal Resource facility," informed Dr A Ashok, director of biotechnology, Government of Andhra Pradesh. Besides, the Andhra government has set up a Marine Biotech Park on a 218-acre site at Parwada near Visakhapatnam. The park set up in association with the Andhra University would also house a marine biotech complex and focus on marine resources, apart from research on marine foods, nutraceuticals and fisheries. Biogenus and Celgen have already been allotted the required land at the park. The government has been receiving enquiries with more companies showing interest to take up ventures in the Marine Biotech Park at Visakhapatnam. In addition to marine and pharma biotechnology, the government has earmarked an area of 200 acres for Agri Science Park at the campus of International Crops Research Institute for the Semi-Arid Tropics (ICRISAT) and a MoU was signed in 2003 between the government of Andhra Pradesh and the director general of ICRISAT. The Park comprises an Agribiotech Park, Agri Business Incubator, a Hybrid Seeds Consortium, and SAT Ecoventure. Three ventures have come up in the Agri-Biotech Park. Amongst them is a facility for testing aflatoxin contamination in food crops. The two other collaborations are with Avesthagen and the Suri Sehgal Foundation. Four companies have joined the Agri-Business Incubator to incubate technologies. These being Rusni Distilleries for the production of ethanol from sweet sorghum; Bioseed Research Ltd. for the development of transgenic cotton; Seed Works Ltd. for the development of transgenic cotton and vegetables; and Sessler Tom and Hyglass for the development of fermentor and agricultural implements. ICICI Knowledge Park The Government of Andhra Pradesh has one more park - ICICI Knowledge Park - to its credit in the knowledge intensive field. Launched by ICICI Bank Ltd in partnership with the state government, the park is focused on facilitating business-driven research and development. The park is spread over 200 acres of campus at Turkapally near Hyderabad. The project is being developed in phases. With full occupancy in the first two phases, the ICICI Knowledge Park is in the process of developing the third phase with an investment of Rs 7 crore to create 22,000 sq ft infrastructure to accommodate 13 laboratories. Already about Rs 42 crore has been invested in setting up the first two phases of the park. As many as 13 companies are operating from this park that offers land plots of varying dimensions to build research centers and pilot plants as per specific requirements of the resident companies. While the park encourages research and development in all knowledge intensive fields, the current focus of the park is in the areas of biotechnology, pharmaceuticals technology, specialty chemicals, new materials, information technology and telecommunications. The park offers fully air-conditioned modular laboratory units with standard facilities and services for establishing state-of-the-art research centers for conducting advanced scientific research. International Biotech Park Similarly the Maharashtra government too adopted a public-private partnership model for developing the biotech park in the state. International Biotech Park (IBP) is a joint venture project between the Maharashtra Industrial Development Corporation (MIDC) and TCG Urban Infrastructure Holding Ltd (TCGUIH), a Chatterjee Group company. With a total investment of Rs 250 crore in the project, MIDC will hold approximately 12 percent of the paid-up capital while TCGUIH will hold the remaining 88 percent. TCGUIH develops, promotes and markets the 110- acre park at Hinjewadi, near Pune. "Now we have about 10 companies and research organizations who have booked space at the park and will start setting up their units in a month's time," informed Bamasish Paul, head of strategic planning and business development, TCG Urban Infrastructure Holdings Ltd. Emcure Pharma and Shreya Biotech have already started operating their activities from the park. Lucknow Biotech Park Though Uttar Pradesh started a little late, it is aggressively developing its biotech park in Lucknow in association with Department of Biotechnology on an eight-acre land. The Lucknow Biotech Park is being set up in collaboration with the Council of Scientific & Industrial Research, New Delhi, universities and industries. Already a few organizations, both domestic and international, have booked space at the park in Lucknow. Shantha Biotechnics, Biotechnology Consulting Research Inc., IQRA Biotech Services - Neurosciences & Physiotheraphy Centre, Clintech Research LLC, New Jersey, Green Path Bio Herbs Industries, and Software Technology Park of India (STPI) have been leased space at the Biotech Park. Besides, Bio Alliance, Germany is interested in a joint venture in the broad field of biotechnology, R&D and training. Odyssey Research Inc. and Acrossworld have expressed their plans for operations in India. The Lucknow Biotech Park has already supplied more than 125,000 fully hardened banana plants to the State Horticulture Board. The park in collaboration with NBRI, Lucknow is raising elite quality of Jatropha Curcas plants and so far about 150, 000 plants have been delivered to the State Farm Corporation India Ltd at cost of Rs 18 lakh. The state is also seriously considering the possibility of cultivating jatropha on 20 lakh hectares of wasteland to produce biofuel and is planning to come out with a biofuel policy to encourage entrepreneurs and farmers. Dr PK Seth, CEO, Biotech Park, said, "Lucknow offers business in biopharma, bioagriculture, bioinformatics and bioservices." Ticel Bio Park Opened in November last year, Ticel Bio Park offers developed space for entrepreneurs to set up research units, and common facilities for testing and analysis. Located near the TIDEL Park at Taramani near Chennai, this park was promoted by the Tamil Nadu Industrial Development Corporation (Tidco) on a five-acre land, provided by the state government. It has technical collaboration from Cornell University of New York and financial assistance from a few banks. The facilities at the park were developed at a cost of Rs 62.50 crore. The park already has three occupants, Vimta-Molecular Biology Labs, SGS Life Sciences Service and Frontier Life Line Pvt Ltd. The management expects full occupancy in the next couple of years. Besides, Chennai has Golden Jubilee Biotech Park for Women Society, with the aim of providing opportunities to prospective women entrepreneurs in the field of biotechnology. This is the only and the first biotech park in India exclusively for women entrepreneurs, which was commercialized in May 2001. It offers centralized support services to a series of biotechnology-based activities by women. Already 13 women entrepreneurs have set up units in this park in different areas of biotechnology. The Government of Tamil Nadu has extended support to the establishment of the first women's biotech park in the country by allotting 20 acres of land at Siruseri village near Chennai, inside SIPCOT-IT Park. The park has created a database of over 500 technologies or projects covering about 150 research institutions that can be commercialized in the park. Being located in a Notified Backward Area, all units in the park are eligible for capital subsidy from the Government of Tamil Nadu. Central Government subsidies are also available for specified industries. These biotechnology parks are acting as bioclusters - where companies, universities and R&D institutes are all located in one place. The state governments too are supporting the industry players who are looking at setting up their units at the parks by offering incubation facilities, tax holidays and incentive package; venture funding initiatives etc. The technical alliance the parks' promoters have entered into, is also attracting entrepreneurs. Considering all this, it is the natural and obvious choice of entrepreneurs to look at these parks for setting up their units. Narayan Kulkarni ]]> <![CDATA[Biopolis looking at additional space]]> https://biospectrumindia.com/news/95/3807/biopolis-looking-at-additional-space.html https://biospectrumindia.com/news/95/3807/biopolis-looking-at-additional-space.html Tue, 16 Aug 2005 17:02:00 +0530 Biopolis looking at additional space     ASIA Biopolis looking at additional space The demand for research laboratories at Singapore's Biopolis, a purpose-built biomedical R&D hub, has been so strong that development of Phase II is already underway in less than two years after Biopolis opened. Phase I with two million square feet of space is over 90 per cent occupied. Phase II with start with two new buildings providing an additional 400,000 square feet of space to house the R&D operations of pharmaceutical and biotechnology companies. "The overwhelming demand for spaces at Biopolis leading to the accelerated Phase II development, signals the exponential growth of the biomedical sciences R&D community in Singapore. It bears testimony to Singapore's success in building a world-class R&D environment," said Yeoh Keat Chuan, deputy director, Biomedical Sciences Group of the Singapore Economic Development Board. "The nucleus of top scientific talent who work at Biopolis, supported by advanced infrastructure and services, is paving the way for world-class drug discovery, clinical development and translational research activities in Singapore," Yeoh added. Chong Lit Cheong, CEO of JTC Corporation, the developer of Biopolis, said: "The demand from pharmaceutical and biotechnology companies for Phase II is expected to be equally high, as companies are attracted by the ability to conduct world-class science research in Singapore. We expect more blue chip companies to follow the lead set by heavyweights like GSK, Novartis and the 15 other companies that have established R&D facilities at Biopolis." Source:www.biomed-singapore.com AUSTRALIA Australia launches 'Biotechnology Online' A major national education resource, 'Biotechnology Online,' aimed at making high-school students more aware of the ethics and scientific principles of biotechnology was launched in Australia by ABC Broadcaster Robyn Williams. Speaking at the national science teachers conference, CONASTA, in Melbourne, Williams said that it was becoming increasingly important to understand both the science and societal issues of contentious emerging biotechnology applications, such as genetically modified foods, or stem cells, and that the schools' resource, Biotechnology Online, can play a significant role in achieving this understanding. "Our high school students are the decision-makers of tomorrow, and it is important that they make their decisions from an informed point of view," he said. Produced and maintained by the Australian Government agency Biotechnology Australia, Biotechnology Online is a curriculum-based, national school resource first developed in 2001. The latest version represents a comprehensive update, with a new interface, much more information, new interactive games, more ethics materials, improved search functions and a module on careers. Biotechnology Online enables schools to supplement their current educational resources with a wide range of case studies, hands-on activities and experiments, games and student worksheets and teacher notes. Source: www.biotechnology.gov.au AMERICA "Mexico is a major region for clinical trials" "Mexico is a major region for clinical trials and there is no doubt that its importance in this field will grow," said Dr Faiz Kermani of Clinical Research Organization Chiltern International. Dr Faiz Kermani further said that the reputation that Mexico can prove a cost effective location for clinical trials has attracted a host of companies to the country. However, commercial advantages can only be gained through a good knowledge of the market, through building a rapport with potential investigators and understanding the society from which patients may be drawn. Furthermore, any cost advantages for clinical trials must be linked to maintaining quality. The country's growing population and the occurrence of major diseases presents a potentially large pool of patients to participate in clinical trials. At present major healthcare problems include cancer, heart disease, cancer, diabetes and diseases of the liver. According to the industry, in 2003, around 26,000 Mexican patients participated in clinical trials and this increased to more than 37,000 patients in 2004. More than 1,800 investigators were involved in carrying out these clinical studies in 20 different therapeutic areas. "Mexico's research environment is evolving rapidly against a backdrop of healthcare and social reforms and these must be understood and appreciated in order to succeed in pharmaceutical R&D, particularly when running clinical trials. It is also important for companies wishing to carry out clinical trials in Mexico that they adhere to high quality standards in order to conform to official regulations and to enhance future prospects for research in Mexico by encouraging the participation of patients and investigators," said Dr Faiz Kermani. EUROPE BIA welcomes new law to crack down on animal rights extremism The BioIndustry Association (BIA) has welcomed the new legislation to combat animal rights extremism (the Serious Organized Crime and Police Act) which became effective on July 1, 2005. This is the strongest ever protection for thousands of individuals, businesses, and academic institutions across the UK, including over 455 bioscience companies employing over 22,400 people, many of whom have been subjected to concerted campaigns of harassment and intimidation in recent years at the hands of animal rights extremists. Aisling Burnand, chief executive, BIA said, "The BIA has campaigned for this change for several years and we are now delighted that this has become law. This legislation eliminates the grey area in which animal rights extremists have previously operated, and will protect companies and individuals engaged in legitimate, groundbreaking bioscience research in this country and, crucially, all those connected with the research. The use of animals in medical research is vital if we are to find treatments for the 50 percent of the world's diseases for which there is currently no cure. Without animal research many widely used drugs and the development of effective new therapies for diseases such as Parkinsons, cancer and diabetes would not be possible." "We congratulate the government on this important legislation, as well as lead campaigners across the political parties. The challenge now is to ensure that the police and the judiciary have the resources they need to implement these new laws," he said. Source: www.bioindustry.org Indian student awarded $5,000 for developing saline-tolerant crops Born in rural India, educated in Indore, and now studying in Canada, Sanjeeva Srivastava's life story is an example of how Canadian innovation and effort are part of a global race to feed the world. Using the complex tools of modern biotechnology, Sanjeeva Srivastava is developing plants that may one day be resistant to conditions as diverse as salinity, drought and cold. The University of Alberta graduate student, Sanjeeva Srivastava, is the latest winner of the Young Scientist Footsteps Award sponsored by the Council for Biotechnology Information. Adjudicated by Genome Prairie, the Footsteps Award recognizes graduate research achievement in the field of plant biotechnology by students under the age of 30. Nominated by his professor Dr Nat Kav of the Department of Agricultural, Food and Nutritional Science, Srivastava is providing new insight into how plants respond to salinity in the soil. His observations of the specific proteins that appear to protect the pea plant from withering under saline conditions led to the transfer of special 'saline-proofing' genes to canola. These new transgenic canola cultivars germinated and demonstrated better seedling growth in saline conditions than their wild-type cousins. "Salinity is one of the most severe environmental factors that impose stresses on plants," explains Srivastava. "This is a worldwide problem which decreases agricultural productivity. It is a real problem in Asia where the tsunami flooded agricultural areas with seawater." Although Canadian farmers may not have to worry about saline stress, his research has the potential to help address issues faced by Canadian agriculture every year - drought and early frost. Source: www.biotech.ca 'Plants for the Future' program sets a European agenda A wide group of stakeholders jointly publish the strategic research agenda 'Plants for the future' on how Europe can improve the safe exploitation of the genetic diversity in plants using plant genomics and biotechnology. Input has been collected from research institutions, industry, farmers, politics, financial world, regulatory authorities, as well as consumer and environmental organizations. "Plants for the Future" is an impressive demonstration of how working together can build competitiveness. This joint effort of all those involved in the agricultural production chain to identify and take into account scientific and technological potential, market drivers and consumer demand can only be positive for the future of the agricultural sector," said Janez PotoÃ¨nik, EU Commissioner for Science and Research.   ]]> <![CDATA["Time is right for BIO to organize a business mission to India"]]> https://biospectrumindia.com/news/95/1934/time-is-right-for-bio-to-organize-a-business-mission-to-india.html https://biospectrumindia.com/news/95/1934/time-is-right-for-bio-to-organize-a-business-mission-to-india.html Tue, 16 Aug 2005 16:50:00 +0530 New Page 1 "Time is right for BIO to organize a business mission to India" - Caroline Ruggieri, manager, International Relations, Biotechnology Industry Organization (BIO). What are your views on the Indian biotechnology industry after your visit to India in February 2005? I am convinced that with the right policy reforms, India is poised to become one of the major contributors to the growth of the worldwide biotech sector. India's existing assets are unparalleled. If properly harnessed, they will propel domestic biotech innovation, while also making the country enormously attractive for foreign investment. How do you see the Indian biotechnology industry compared with the biotechnology industry in other developing countries? The passing of the Third Patent Amendment shows the world that India is serious about creating enabling conditions for innovation. Additional reforms are needed in IP and elsewhere, but this important first step sends a powerful message to the developing world that India is leading the way. In addition, it is significant to note that the Indian delegation to our annual conventions has steadily increased over the years, and now India's delegation is one of the largest from the developing world. This also delivers the message that domestic companies are equally serious about innovation and collaboration. Does BIO have a specific platform besides the mega event BIO which is being held in June/July every year, wherein international affiliates can get an opportunity to discuss one-on-one various issues of mutual interest? We hold a smaller CEO & Investor conference every February that facilitates networking with the financial community as well as one-on-one partnering discussions. We also have a series of smaller partnering conferences in the US, Europe, and Japan. These are all business development events that all offer companies the opportunity to meet one-on-one with other companies to explore possibilities for collaboration. In order to help corporate/organizations do you conduct membership drive in other countries? If yes, do you have any plans of conducting membership drive in India to increase the membership? While we do not have a formal membership recruitment strategy for overseas companies, we invite biotech companies from anywhere in the world to be a member of BIO and to participate actively in our activities. In what way will BIO support/help the industry in India? I believe the time is ripe for BIO to organize a business mission to India to introduce our companies to the local industry players. I'd like to see this happen in early 2006. In addition, we work with the US-India Business Council in Washington to support their policy advocacy. We're also open to any other suggestions coming from Indian companies as to how BIO can be more supportive. Narayan Kulkarni ]]> <![CDATA["Kendro Acquisition Provides Valuable Extension"]]> https://biospectrumindia.com/news/95/7432/kendro-acquisition-provides-valuable-extension.html https://biospectrumindia.com/news/95/7432/kendro-acquisition-provides-valuable-extension.html Tue, 16 Aug 2005 16:05:00 +0530 INTERVIEW INTERVIEW "Kendro Acquisition Provides Valuable Extension" - Patrick Loh, director of Commercial Operations, Asia Pacific and Arab Peninsula Region, Thermo Electron Corporation Patrick Loh, director of Commercial Operations, Asia Pacific and Arab Peninsula Region, Thermo Electron Corporation spoke to BioSpectrum's Narayan Kulkarni about Thermo's plan in India after the acquisition of Kendro. Excerpts from an interview: How will the acquisition of Kendro by Thermo help the customers at large and Indian customers in specific? Thermo Electron is the world's leading company with a turnover of over $2.2 billion. Thermo today is proud to supply some of the world's highly respected brands of products like Labsystems, Forma, Savant, Jouan etc. The addition of Kendro's range now brings us much closer to our goal of becoming the premier supplier of products and services for the laboratory. Kendro's addition to Thermo provides Thermo Electron with a valuable extension to its team and new product families that will add industry leading centrifuge and thermal equipment. This will surely allow us to be more flexible in our product offerings to customers and increase service capabilities. The combination of Kendro and Thermo allows us to offer our customers the strongest, most comprehensive line of laboratory equipment products and value-added services in the industry for preparing, processing and storing laboratory samples. With this acquisition, how do you see the growth and market opportunities in Asia Pacific and India in particular? Definitely Thermo sees this as an opportunity to increase its market share. With the wider range of product and service offerings to our customers, we now can further strengthen our market positions in each market. Which Asia Pacific country is offering more business to Thermo considering the growth potential of biotechnology? The focus region for Thermo is Asia-Pacific. The growth rate of the Asia Pacific region is very good and is sure to continue. India definitely is one of the fastest growing markets apart from China, Japan and Korea in the Asia pacific. Under what brand name will Kendro's products be sold in the market? The Kendro Laboratory Products company name (and other company names) will be replaced by Thermo Electron Corporation. Many of Kendro's individual product names are well respected and Thermo will continue to use them. What will be the fate of the dealers and distributors of Kendro in India? No changes are occurring immediately regarding product line/distributor relationships. However, all current relationships will be studied for their value for Thermo to go forward through the rest of 2005. Also our goal is to include all our distributors/channel partners in the study. Who will be the sales contact for the customer in requirement for a Kendro product? The sales contact would remain the same. We do not anticipate any radical changes in the combined sales force of Kendro and Thermo Electron immediately. ]]> <![CDATA[BioSpectrum Starts Student Lecture Series]]> https://biospectrumindia.com/news/95/2309/biospectrum-starts-student-lecture-series.html https://biospectrumindia.com/news/95/2309/biospectrum-starts-student-lecture-series.html Tue, 16 Aug 2005 15:26:00 +0530 From Left From Left: Prof. Yatnatti, SUCAB Centre, Prasad MP, Sangene Biotech Pvt Ltd and E Abraham Mathew at the event. BioSpectrum Starts Student Lecture Series The first-ever Student Lecture Series organized by BioSpectrum kicked off to a very enthusiastic start at the packed Dr Ambedkar Bhavan auditorium in Bangalore on July 23, 2005. Speaking after inaugurating the event, E Abraham Mathew, Chief Editor, BioSpectrum, pointed out that BioSpectrum has done extensive coverage on the biotech industry and achieved tremendous success in all its endeavors in a short span of just two years. It was BioSpectrum, which mapped the size of the biotech industry of the country for the first time, he informed adding that the Indian biotech industry had crossed the $1 billion mark. Stating that the industry had set itself a target of $5 million by the year 2010, he gave a call to the students to contribute towards realizing this dream by the year 2009 itself. Mathew said the lecture series was a great opportunity for students, who were the future captains of the biotech industry, to interact with the leaders of the life sciences industry and this would help students mesh their learning with the requirements of the industry. With an objective "to provide a framework to engage and educate students about the promises and challenges of biotechnology", the series would be held across 10 cities in the country over the next six months. While Dr BV Ravikumar, managing director, XCyton Diagnostics Limited, spoke on the diagnostics market scenario in the country, Dr R Soudhamini, who leads a research team at the National Centre of Biological Sciences lectured on "Development of resourceful computer packages for protein structure modeling." Narayanan Suresh, Editor, BioSpectrum, gave an overview of the biotechnology sector. The other speakers were Dr Mittur N Jagadish, director, Monsanto Research Center and Dr Kratish Bopanna, chief technology officer, Manipal Acunova Pvt Ltd. The sponsors for the event were Sangene Biotech Pvt Ltd and SUCAB Centre. "The event was informative as the lectures included topics covered in our syllabus and also topics on the recent advancement in the industry. It was a good idea to cover career prospects also in the lectures and such events will definitely go a long way in helping students tap the potential within them to build their careers in biotechnology. I feel the lecture series should not be restricted to only 10 cities in the country. It would be better if it were to be extended to other places also," commented Priyank Dashora, a IInd year B Sc student of Padmashree Institute of Information Sciences. According to Kavitha Agarwal, a IIIrd year B Sc student of Mount Carmel College, "The program was really good. The speakers addressed all queries of the students regarding careers and now we are clear about what we want to do next. It is a good move that BioSpectrum will publish more student queries and also respond to the same in the forthcoming issue of the magazine and also post it on the website." "All the lectures were very informative as the topics went beyond the confines of classroom lectures and I hope BioSpectrum makes this a monthly affair. Overall it has been a nice experience participating in the event," said Megha Basu, a IIIrd Semester B Sc student of Goutam College of Science. "It was nice to know about the job opportunities in the biotech sector but I expected the lectures to cover more of academics-based topics. I hope in future the lectures will include topics which are more relevant to students at the undergraduate level," added K Divya Sharma, IIIrd year B Sc student, Mount Carmel College. "The best part of the event was the whole perspective of the students focusing on what they could do in specific biotech companies. We also got to know more about the industry. I feel the lectures should focus primarily on what the students would be interested in rather than giving an overall view. More topics on bioinformatics and the R&D going on in the country should be included in the series," expressed Sanjana Rao who is doing her PG Diploma in Bioinformatics at IBAB. Over 800 students participated in the event and several outstation students have requested BioSpectrum to conduct these lectures in several cities. On its part, BioSpectrum announced 10 lucky winners for complimentary subscription to BioSpectrum for a year. Namratha Jagtap ]]> <![CDATA[BioPharma Product Pipeline Swells]]> https://biospectrumindia.com/news/95/1811/biopharma-product-pipeline-swells.html https://biospectrumindia.com/news/95/1811/biopharma-product-pipeline-swells.html Mon, 11 Jul 2005 15:41:00 +0530 New vaccines and biotherapeutics guide the Indian biopharma sector The Biopharma segment has been the key driver in the journey of the Indian biotechnology industry to the crucial $1-billion mark. The segment contributed about 75 percent, nearly Rs 3,570 crore of the total Rs 4,745-crore Indian biotech market. Biopharma is the space being eagerly watched by the industry. With India embracing the product-patent regime in January 2005, the sector is seeing a subtle shift from generics to innovation led research. Most of the big pharma companies are expanding their R&D base and developing a strong product pipeline. In fact vaccines and recombinant therapeutics are the twin areas where many of the companies are diversifying and strengthening their product portfolio. The present Indian biopharma industry comprises vaccines, therapeutics and other products like statins and diagnostics. And as compared to the previous fiscal, the biopharma sector itself registered a healthy 30 percent growth in FY 05. The vaccine business accounted for 47 percent of the total biopharma business during 2004-05 and grew from Rs 1,295 crore in 2003-04 to Rs 1,669 crore in FY05. The vaccine leaders Significantly, three of the top five companies as per the BioSpectrumâ€“ABLE 2005 survey, are into the vaccine business. Serum Institute of India, the second largest biotech company, is one of the largest manufacturer of measles vaccine and DTP group of vaccines in the world. It grossed revenues worth Rs 505 crore during the FY 05. Panacea Biotec, the number three-ranked company, is the top oral polio vaccine supplier in the country with biotech revenues amounting to Rs 217 crore during 2004-05. The company registered an impressive 46 percent growth in its biotech business. Venkateshwara Hatcheries which ranked number four is the country's leading poultry vaccine maker. It registered a phenomenal 113 percent growth in its business. The other important Indian vaccine manufacturers in the country include Indian Immunologicals, Shantha biotechnics, Bharat Immunologicals and Biologicals, Bharat Biotech and Biological E among others. Aventis Pharma, Chiron Behring Vaccines, GlaxoSmithkline Vaccines are some of the leading global pharma giants having a strong presence in India. Emerging trends So what is the business plan of the prominent players in this segment post TRIPS regime in India? Most of the companies operating in this area are diversifying into other vaccines, while maintaining their traditional strongholds. India is clearly developing as the vaccine hub of the world. For example, Serum launched its unique Rabies vaccine called Rabivax in December 2004 and is now focusing on Hepatitis, HIV, BCG and TB vaccines. In the current financial year, the company is planning to make combination pentavalent vaccines (DPT, HepB and Hib) at its new facility in Pune. Similarly Panacea has developed and launched several novel vaccines during the year, which include Recombinant Hepatitis B (Enivac HB), Enivac HB Safsy, and combination vaccines like Ecovac (DPT+Hib B), Ecovac safsy, Easy Four (DPT+Hib) and Easy Five (DPT-Hib-HepB). It will soon be coming up with a recombinant Anthrax vaccine, which is undergoing Phase I/II human clinical trials and a tissue culture based JEV, which is in the preclinical development phase. It has also filed a world wide patent for new NDDS for an anti-TB combination drug recently. Panacea is not only increasing its product portfolio, but is also ushering a paradigm shift in how the vaccines are being transported and administered thus changing the face of the industry. It has entered into collaboration with UK-based Cambridge Biostability, for manufacturing vaccines in India using the "Stable Liquid Technology". This reformulates existing vaccines into ready-to-inject stable liquids thereby revolutionizing the vaccine delivery system by eliminating the need of refrigeration for vaccine storage. Panacea Biotec will probably be the first company in the world to develop and commercialize this technology. In order to further foray in this sector, Panacea is setting up a new research center at Mohali in Punjab and a new vaccine research center at New Delhi, which will be focusing on the new drug discovery and vaccine research projects respectively. The company is also setting up a new animal house as per the stipulated guidelines. Another example to illustrate this trend is Shantha Biotechnics, which generated a major chunk of its revenues from the sale of its Hep B vaccine during 2004-05. It has signed an agreement with IVI, Korea for technology transfer of typhoid vaccine; National Institute of Immunology, New Delhi for controlled release Hepatitis-B vaccine; Indian Institute of Science, Bangalore for anti-malarial drugs; Bhabha Atomic Research Centre, Mumbai for plant-based vaccines and Polytherics Ltd, London, UK for Pegylation technology for developing Pegylated Interferon. The company has a significant pipeline of products in the vaccine segment - basic pediatric and enhanced pediatric vaccines, combination, adult and travel vaccines. In a similar fashion, Bharat Biotech which entered the vaccine segment through its Hepatitis B vaccine route (RevacB) is now working on Rota and malaria vaccine. The company has also set up a manufacturing plant for vaccines and generic drugs near Johannesburg in a joint venture with a South African company. Biological E, another big pharma player, which has been supplying DPT and TT vaccines to the National Immunization Program, launched "Bevac", its recombinant Hepatitis B vaccine during the FY05. In addition the company has recently signed an agreement with Intercell AG, a US-based biotechnology company, for the development, manufacture and sale of its new Japanese Encephalitis (JE) vaccine, in Asia. It also plans to manufacture combination vaccines like DPT and Hepatitis B at its new vaccine facility in the SP biotech park. Global players like GlaxoSmithKline (GSK) are not only launching new vaccines in India but are also shifting the clinical research and development of vaccines to India. GSK India has been supporting GSK Biologicals in its vaccine development process through its clinical data management center in Bangalore since the last 10 years. Now GSK Biologicals is looking at developing India as a global hub for clinical research and development. It has lined up global trials of four vaccines - two vaccines for Rotavirus, one for cervical cancer, and a combination DPT vaccine in India during 2005. GSK Vaccines was the first company to introduce Hep B, Hep A, Chickenpox, meningitis and a combination vaccine of DPT-HB/Hib in India. Its product portfolio consists of 11 vaccines for both adult and pediatric segments. GSK Vaccines has also launched Mencevax ACWY, the first and only meningitis vaccine available in India. Another interesting trend is that the animal healthcare companies are expanding their manufacturing expertise to human healthcare in a big way. After consolidating its hold on the poultry vaccine market, the Venkateshwara Hatcheries group is working on three major vaccines for ailments that affect a majority of the common populace and are expected to be released in 2007. Common cold and cough, arthritis and pneumonia are some of the vaccines that will hit the market in the next 18-19 months. The vaccines are in the final stage of development. The company has applied for an Indian patent and has already obtained the US patent for these vaccines. It is presently working on the mode of dispensing the vaccines oral or injections. It is also investing in new vaccines and biotherapeutics for child and adult immunization. The company has entered into a tie-up with a US-based company for biodiagnostics and biogeneric products with the aim to bring certain new molecules for diseases like cancer. Venkateshwara has plans to enter the protein drug sector as well. Similarly, Indian Immunologicals, a top notch animal healthcare company and one of the largest manufacturers of foot and mouth disease vaccine, has filed seven international patents on novel combination DNA rabies vaccine. Biotherapeutics During 2004-05, the Indian therapeutics market recorded 20 percent growth and grew to Rs 500 crore. Most of the major biopharma players are showing keen interest in this segment. The year marked Biocon's foray into the protein therapeutics segment. Biocon launched Insugen, recombinant human insulin, in the domestic market, which accounted for a sale of Rs 10.13 crore since its introduction in mid November 2004. Shreya Life Sciences, the Indian arm of Moscow-based Shreya Corporation too launched rDNA human insulin under the brand name Recosulin in December 2004. Novo Nordisk, Aventis Pharma, Eli Lilly and Wockhardt were the already existing players in the Indian human insulin segment. This has led to increased competition in this space and as a result of this, pricing pressure is expected in this segment. This is a cause of concern for the industry that if too many companies start concentrating on the same product, then it would not only result in loss of revenues for the companies but also kill the market for that product. This fiscal also saw Biocon strategically develop a few collaborative in-licensed R&D programs. It entered into a joint research program with US biotech company, Nobex Corporation to develop oral insulin and expects to file an INDA with USFDA by the end of 2005. The joint R&D program is based on Nobex's proprietary conjugated peptide delivery platform. In addition, Biocon entered into a strategic partnership with Rochester-based biotechnology company Vaccinex Inc. for antibodies. The partnership will enable the companies to develop a pipeline of novel human therapeutic monoclonal antibodies. The four-arm phase II human clinical trial for Biocon's drug TheraCIM (h-R3), a humanized monoclonal antibody, also commenced during the year. The antibody is being evaluated for its efficacy on head and neck cancers. The trials are later planned to be extended to other indications including pancreatic and colo-rectal cancer, glioblastoma, breast and lung cancers. This drug is being developed by Biocon Biopharmaceuticals, Biocon's joint venture with the Cuban Institute CIMAB. This initiative marks a substantial advancement in Biocon's recombinant bio-therapeutic portfolio. Significantly, the drug, TheraCIM, has already received a fast track approval from the National Regulatory Authority of Cuba and 'Orphan Drug' status from the EMEA (European Agency for the Evaluation of Medicinal Products) to treat cancer patients. Biocon envisions these R&D programs as rapidly developing into very large global opportunities over the next 3-4 years. Shantha Biotechnics, which is equally diversified into vaccines and therapeutics segment, has launched a series of recombinant biotherapeutic proteins in the Indian market during the past three years. It launched Shanferon in 2002, a recombinant human interferon alpha 2b indicated in the treatment of chronic myeloid leukemia; renal cell carcinoma; hepatitis-B; hepatitis-C among other diseases; Shankinase in 2004, a recombinant streptokinase used in the indications of acute myocardial infarction, deep vein thrombosis and pulmonary embolism; and recently in January 2005, Shanpoetin, a recombinant human erythropoietin indicated for treating anemia in chronic renal failure patients and anemia induced by chemotherapy in cancer patients. The sale of therapeutics including erythropoietin, interferon, streptokinase and growth factors accounted for Rs 6.7 crore during the FY 05. Its future pipeline of therapeutic products include: Tissue Plasminogen Activator, Anti GP IIb/IIIa, Human Insulin, Peg Interferon, TNF Alfa; Oncology Products: G-CSF, human monoclonal antibodies RM I, RM II, RM III, RM IV and Anti EGFR. Shantha has a subsidiary, Shantha West Inc. in San Diego, US, which is engaged in basic research in monoclonal antibodies for therapeutic applications in the oncology segment. Another company consolidating its biotech portfolio is Wockhardt. The company currently has three biotech products namely Biovac-B (Hepatitis B) Vaccine, Wepox (erythropoietin) and Wosulin (rDNA human insulin) and a robust pipeline of biopharmaceutical products in various stages of pre-clinical and clinical trials. It has completed phase III clinical trials on interferon alpha 2b used in the management of cancer. Preclinical work has been completed on the growth stimulating factors (GCSF) and glargine a new advance on insulin. While global players like Novo Nordisk plans to strengthen its diabetic care presence in India by introducing haemostasis management, it is working towards launching NovoSeven, a recombinant Factor Vll a for treatment of bleeds in haemophilia A and B patients with inhibitors, in India by the year-end. The company plans to cover red blood cell transfusion, reduce complications like multiple organ failure and acute respiratory distress syndrome besides others. Eli Lilly also plans to introduce a few more products in the country in the near future. Thus the impetus on discovery led research is leading to an impressive product line-up in many companies. Rolly Dureha ]]> <![CDATA[Suppliers Snippets]]> https://biospectrumindia.com/news/95/2203/suppliers-snippets.html https://biospectrumindia.com/news/95/2203/suppliers-snippets.html Fri, 08 Jul 2005 11:38:00 +0530 GE, Pall form new alliance to provide water solutions GE Infrastructure, Water & Process Technologies, a unit of General Electric Company, and Pall Corp. announced expansion of their strategic alliance to bring innovative water technologies to the global marketplace. The companies will combine their advanced membrane technologies and separation solutions to cover more applications and markets, including desalination, water reuse and municipal water. Building upon a January 2004 agreement, which integrated GE's advanced design reverse osmosis and nanofiltration systems and services with Pall's high performance microfiltration and ultrafiltration technologies, the new alliance paves the way for collaboration on the development and sale of proprietary technologies. Vivascience expands Vivapure product line Vivascience, a subsidiary of Sartorius AG, has further expanded the Vivapure sample preparation product line by introducing a new human albumin and IgG depletion kit. The Vivapure Anti-HSA/IgG Kit utilizes a combination of Anti-HSA antibody fragment and Protein G resin for specifically depleting albumin and IgG from human samples. The kit provides over 95 percent removal of albumin and IgG from 20 µl of human serum along with low non-specific binding of potential serum biomarkers. Albumin and IgG depleted samples are recovered in a low salt buffer, facilitating downstream applications. The method is quick and claimed to be suitable for parallel processing. With this kit, Vivascience expands its range of Vivapure sample preparation products-Vivapure Anti-HSA kit for albumin depletion, Vivapure Anti-HSA Resin for albumin depletion from serum volumes up to 400 µl, and Vivapure Ion Exchange spin columns for sample fractionation. The new Vivapure Kit further improves the resolution and detection of lower abundance sample proteins by electrophoresis, chromatography, and mass spectrometry. Agilent, Rosetta integrate their flagship products Agilent Technologies Inc. and Rosetta Biosoftware announced that their flagship gene expression analysis products-Agilent's GeneSpring software and Rosetta Resolver system-are being integrated through the use of the Rosetta Resolver Software Development Kit (SDK). While the Rosetta Resolver system is a gene expression data management and analysis system, GeneSpring software is a visualization and analysis solution for displaying and analyzing large gene expression datasets on a typical desktop computer. BD acquires FFE Weber Becton, Dickinson and Co.'s, Diagnostics group, has acquired the assets and technologies of FFE Weber GmbH, a privately held company based in Munich, Germany. The financial terms were not disclosed. FFE Weber, which specializes in the separation and fractionation of complex proteins, has developed the technology that enables a pre-analytical protein separation step that, when used in combination with high performance liquid chromatography (HPLC), 2D-gel and mass spectrometry-based protein analytical procedures, allows deeper interrogation into the plasma proteome than is possible with current methodologies. Fingerprint attendance machine introduced in India RS Barcoders, a company operating in the field of solutions on Barcode and RFID, has introduced TAS-300 Fingerprint attendance machine from BIOBIO- Taiwan in India. According to the company, the TAS-300 biometrics (Fingerprint) attendance machine has a fingerprint matching speed of less than one second. Its False Reject Rate (FRR) is less than one percent and False Acceptance Rate (FAR) is 0.0001 percent and its optical sensor makes it possible to read sweaty fingers also. TAS-300 can function with fingerprint only, fingerprint plus PIN and PIN only. The starting price for the machine is Rs 39, 000 onwards. ]]> <![CDATA[Frost & Sullivan Award for SAS]]> https://biospectrumindia.com/news/95/1769/frost-sullivan-award-for-sas.html https://biospectrumindia.com/news/95/1769/frost-sullivan-award-for-sas.html Fri, 08 Jul 2005 11:32:00 +0530 The 2005 Frost & Sullivan Business Development Strategy Leadership Award was conferred on SAS, in recognition of its well defined, growth strategies enabling it to become a leader in the global bioinformatics market. "SAS has made a considerable impact on the global bioinformatics market," noted Frost & Sullivan Healthcare Analyst, Raghavendra Chitta. "SAS' established, visionary and innovative teams in R&D, sales and marketing, combined with strong solution portfolios and definitive growth strategies, have set SAS in good stead." Today, most Fortune 500 Life Science companies benefit from SAS' core technology within R&D and other departments. The company has developed solutions to serve the drug discovery and development process. Pioneering software within scientific discovery include SAS Microarray, SAS Genetic Marker and SAS Proteomics and SAS Drug Development within the clinical arena. The launch of the latest version of SAS' suite of bioinformatics solutions, the SAS Scientific Discovery Solutions, has given SAS the unique distinction of being the only company capable of offering end-to-end technology to drug companies, with SAS solutions in scientific discovery and clinical research through to commercialization and beyond. Labindia launches Microarray service facility Labindia Instruments, a leading sales, services and support company to the life sciences industry, has launched a state-of-the-art microarray service facility at its Gurgaon Lab. This "Microarray Service Facility" is believed to be the first of its kind in India and is complete with Applied Biosystems Expression Array System Model 1700. Launching the facility, the director general of the Indian Council of Medical Research, Prof. NK Ganguly, said, "There is a need for many more such facilities. The companies should also look at training students in these facilities on a charged basis to generate quality manpower." VS Upadhye, director, Labindia, said this service could be used by all pharmaceutical companies working in molecular biology or more specifically "Gene Expression Area" or by scientists from research institutes and also by funding agencies who could have a "proof-of-concept" before approving any particular project. The facility will offer the whole genome gene expression studies for human, rat and mouse systems. He further added that DNA Microarrays offer a powerful means of interrogating gene activity, which can monitor the whole genome on a single chip so that researchers can have a better picture of the interactions among thousands of genes simultaneously. Established in 1982, Labindia was the top biosupplier and services company in 2004-05 in the BioSpectrum-ABLE Survey . It is an exclusive provider of the products and solutions of leading players like Applied Biosystems and Leica in India. Praj acquires global rights for ethanol fuel technology Praj Industries Ltd, a leading ethanol supplier, has signed an agreement with Delta T Corporation, USA, for worldwide licence rights of the latter's molecular sieve (molsieve) dehydration technology for fuel ethanol production, on a non-exclusive basis. It may be recalled that in the Year 2001, Praj had entered into an agreement with Delta T for technology transfer licence of Molsieve based dehydration process in select territories. The 2005 transaction extends Praj's rights to molsieve-based dehydration technology for its use worldwide. "This is a move to consolidate Praj's global aspirations and enable Praj to penetrate growing developed markets, currently under exploration," said Pramod Chaudhari, chairman, Praj Industries. ... launches bionutrient for ethanol industry In another development, Praj has announced that it has developed "MashTone", a new bionutrient for the ethanol industry. "MashTone is a nutrient formulation for alcohol fermentation that improves the fermentation performance resulting in high rate of yeast metabolism, healthy growth and improved yield. It is one more milestone in the biotech capabilities and in our commitment to customer care as this product enables distilleries to seek higher returns from their investments while strengthening after sales service," informed Chaudhari. ]]> <![CDATA[Scientists coax brain cells to grow in a dish]]> https://biospectrumindia.com/news/95/1645/scientists-coax-brain-cells-to-grow-in-a-dish.html https://biospectrumindia.com/news/95/1645/scientists-coax-brain-cells-to-grow-in-a-dish.html Fri, 08 Jul 2005 10:59:00 +0530 After coaxing heart and liver cells to grow in vitro, scientists have been able to successfully grow brain cells in a dish. Regenerative medicine scientists at the University of Florida's McKnight Brain Institute have created a system in rodent models that for the first time duplicates neurogenesis - the process of generating new brain cells in a dish. This cell culture method holds the potential promise of producing a limitless supply of a person's own brain cells to heal disorders such as Parkinson's disease or epilepsy. "It is like an assembly line to manufacture and increase the number of brain cells," said Dr Bjorn Scheffler, a neuroscientist at Florida University who made the breakthrough. "We can basically take these cells and freeze them until we need them. Then we thaw them, begin a cell-generating process, and produce a ton of new neurons." If the discovery can translate to human applications, it will enhance efforts aimed at finding ways to use large numbers of a person's own cells to restore damaged brain function, partially because the technique produces cells in far greater amounts than the body can on its own. In addition, the discovery pinpoints the cell that is truly what people refer to when they say "stem cell." Although the term is used frequently to describe immature cells that are the building blocks of bones, skin, flesh and organs, the actual stem cell as it exists in the brain has been enigmatic, according to Dennis Steindler, executive director of the McKnight Brain Institute. Its general location was known, but it was an obscure species in a sea of cell types. "We've isolated for the first time what appears to be the true candidate stem cell," said Steindler. "We used a special microscope to watch living cells over long periods of time through a method called live-cell microscopy." he added. ]]> <![CDATA["The genographic project will allow individuals to trace their own migratory history"]]> https://biospectrumindia.com/news/95/1533/the-genographic-project-will-allow-individuals-to-trace-their-own-migratory-history.html https://biospectrumindia.com/news/95/1533/the-genographic-project-will-allow-individuals-to-trace-their-own-migratory-history.html Thu, 07 Jul 2005 15:39:00 +0530 Ajay Royyuru, head, Computational Biology Center at IBM's Thomas J Watson Research Cente, is the lead scientist for IBM on the Genographic Project. He is working closely with Dr Spencer Wells of National Geographic and the distinguished team of field researchers assembled to conduct DNA testing on indigenous populations of the world. In an exclusive interview, he speaks about the project. How did the concept of the Genographic project take shape? The Genographic project really began with Dr Spencer Wells, a population geneticist and now a National Geographic explorer-in-residence, when he was applying population genetics to understand human migration during an earlier project. Wells was then studying the genetic markers on the Y chromosome in populations across the southern coasts of Asia and was able to connect the markers with those occurring in the populations in Africa and in Australia. This established the land migration of people from the African continent to Australia some 45-50,000 years ago. Based on these observations, Wells wrote a book called "The Journey of Man". At that point of time he wondered if this methodology could be applied to the entire population of the world. Since it would be impossible to get data from all the six and a half billion individuals of this planet, so if data could be collected from a few million people, then how would that story be. That would be the story of migration of people in the eternity of time all the way from the center of origin of humans in Africa to present day in all corners of the world. It would tell a tale of how human beings have developed as a species in the last 200,000 years. How is the project being executed? The project was officially launched on April 13, 2005 at an event in Washington DC. We are now going around the world and telling people in each of the geographies about what the project is going to be, inviting their comments and listening to them. The Genographic project, an innovative five-year research partnership, will use sophisticated laboratory and computer analysis of DNA contributed by hundreds of thousands of people. The project is a partnership between the National Geographic and IBM, with support from the Waitt Family foundation and the public. Participation from the indigenous populations and the general public forms the core of the project. Wells and a consortium of scientists from prominent international institutions will conduct the field and laboratory research. It is aimed that least 100,000 blood samples will be voluntarily collected from the indigenous populations of the world, who are a key aspect of this project. They have a story to tell about ancestry. It is their distinct existence, cultural and genetic distinctness that provides the clearest signpost in this historic view of human migration. Their DNA information will be collected via the blood samples. For this purpose, ten research laboratories have been identified around the globe, each affiliated with a university or similar institution which would sample indigenous population in a particular geographic area. An international advisory board will oversee the selection of indigenous populations for testing as well as adhering to strict sampling and research protocols. The public can take part by purchasing a participation kit and submitting their own cheek swab samples. The public participation samples are being processed by Family Tree DNA Inc, in association with the university of Arizona and the results will be posted on the website in about four to six weeks time. Then one can log on the website and track the overall progress of the project as well as learn their own migratory history. As more and more data is gathered the patterns get richer and richer. In all the samples the individual results focus on a small number of genetic markers in the non recombinant Y chromosome of males and the mitochondrial DNA in females. What does the project aim to achieve? The objective of the Genographic project is to trace the migratory history of all people on the planet. The project is actually trying to connect many pieces of evidences, the genetic evidence being only one of them - anthropological, cultural, linguistic, geographic; we have had all this kind of data as handed down information. Most of us have the knowledge about who our ancestors were going back to a few generations. Beyond that we have information through oral history, our culture, our scriptures, etc. But we do not have any way to trace our ancestry to any migratory event that has populated our subcontinent. The question that we would like to answer through this project is 'which was that migratory event that has populated my ancestors in this land and where did they come from? And how did my ancestors populate other parts of the world?' Essentially the whole world is one big family and we only have to go back in time to recognize this fact. The diversity that we see crossing this map is the result of this migration and how the paths have crossed of various people. Merely 15 thousand years ago we had a common ancestor and today we are all in different parts of the world and speak different languages. This project provides an opportunity to recognize the similarity that exists between us and to appreciate how related we all are. What is the role of IBM in the project? IBM is a partner in the Genographic Project. It is contributing very heavily both towards the design and the execution of the project. IBM is putting the technology infrastructure in place in all the 10 regional centers. We are providing computer systems, softwares, basically the capability to gather the data. Then we are using very sophisticated communication technology, encryption packaging, for sending the data from all the regional centers to the center that we have set up in Washington DC, National Geographic headquarters for storing the data and a good amount of computing infrastructure to analyze the data. The challenge for IBM is in the data analysis because of its scale. What we are really trying to tell is that of all the diverse populations that we see, what is our shared ancestry and how did that diversity come upon. We should be able to weave the fabric of human history of migration and the journey that our ancestors traveled by getting the genetic threads and tying them all together. If one thinks about the genotype as a set of markers that are being used on an individual and the phenotype as all the cultural traits: languages that you speak, geographic location that you are in today and so on. We are looking for correlation in this space and they constitute an interesting observation in this exercise. How is it being ensured that the data generated from the samples will not be misused? As we are asking people to volunteer perhaps their most personal information - their own DNA, so we have to make sure that it is held with the highest degree of security and privacy. We ensure this through three means. First we gather only that information which is useful for the project and we are not asking for any information other than that. Like for example we are not asking for any medically relevant information. We are not genotyping volunteers for markers that might be indicative of disease traits or any medical outcome. We are only looking for markers that speak of deep ancestry. These essentially are markers on the Y chromosome and on the mitochondrial DNA. The only other information that we know about the volunteer is their gender and that too is self-confessed. The second aspect is the anonymity of participation. We do not ask volunteers for their name. Each kit has a random code assigned to it on the inside and we have no clue which kit went to whom. So when a person receives a kit, the code is the identifying number, which the person will use to track his data in the project. The third is our commitment to the project of being very public about anything we do. We will publish research results as and when we arrive at results and will disseminate them through the National Geographic website, channel, magazine and all other means of communication available to us. As the project progresses, we will put all the gathered data in the public domain and will not be patenting any information that is generated out of this data. Our being very public will prevent any accidental abuse of the data by any organization or individual. Lastly in all the regional centers, the IBM thinkpad provided to collect the data is equipped with a biometric fingerprint scanner in the machine enabling only the authorized people to enter and have look at it. This is another way by which we are ensuring that the data is secure. In this way we are going to address the concerns that people as to how are we going to protect their most personal data. Rolly Dureha ]]> <![CDATA[Mascon Life Sciences launches EXOMEBlas]]> https://biospectrumindia.com/news/95/2776/mascon-life-sciences-launches-exomeblas.html https://biospectrumindia.com/news/95/2776/mascon-life-sciences-launches-exomeblas.html Thu, 07 Jul 2005 15:37:00 +0530 Mascon introduced EXOMEBlast, an iterative and comparative BLAST tool. This is a customized tool, which facilitates to perform BLAST against local databases and NCBI Blast database and user defined/created databases as well. One can compare, filter and append the results and store in the local databases. The EXOMEBlast offers iterative blast, quick building of local databases, comparative blast, efficient filtering, visualization and operates in a user-friendly environment. For further details, contact: Vibhav Garg (g.vibhav@mascon.co.in) Thermo introduces LTQ Orbitrap for small molecule research Thermo Electron Corporation introduced a hybrid mass spectrometer, LTQ Orbitrap, for small molecule research, drug discovery, proteomics, metabolite identification, and metabolomics. The LTQ Orbitrap is claimed to represent the first totally new mass analyzer to be introduced to the market in over 20 years. Combining patented Orbitrap technology with its successful Finnigan LTQ front-end, the LTQ Orbitrap enables faster, more sensitive and more reliable detection and identification of compounds in complex mixtures. This product is touted as a clear alternative to the existing hybrid Time-of-Flight systems. For more details, contact: shashin.shah@thermo.com Waters to introduce new emitter, sprayer Waters Corporation will introduce a new emitter and sprayer for capillary and nanoflow mass spectrometry applications. Waters NanoEase Emitter can also be used at nanoscale or capillary flows ranging from 100 nL/min up to 10 m L/min compared to alternative emitter designs requiring different pulled or tapered-tip diameters based upon operating flow. The NanoEase Emitters are optimally developed for use with Waters new Universal NanoFlow Sprayer. This Sprayer is designed with a nebulizing gas sheath and has a slide-and-lock union holder to facilitate alignment of the Emitter in the union. The Sprayer utilizes a zero-dead-volume micro union so that the Emitter and column outlet are precisely mated end-to-end. For more details, contact: lp_raman@waters.com Corning announces new surface products for enhanced cell attachment Corning Life Sciences, a global supplier of scientific laboratory and drug discovery products for more than 90 years, announced the addition of 6, 12, and 24 well plates, 35, 60, and 100mm style dishes and the 235 cm2 expanded surface flask to the new Corning CellBIND Surface family of products. The Corning CellBIND Surface represents the first innovation in cell culture surface treatment in more than 20 years. The unique surface improves consistency and provides more uniform cell attachment across well, dish and flask bottoms, allowing for higher cell yields. The Corning CellBIND Surface is a patented technology using a microwave process to improve cell attachment by modifying the polystyrene and incorporating more oxygen into the cell culture surface, rendering it more hydrophilic and increasing surface stability. The increased stability of the surface allows for more consistent cell attachment, as cells are less likely to be removed during washing steps and media changes. The Corning CellBIND Surface is a nonbiological surface and does not require special handling or storage. Additional Corning CellBIND Surface products include roller bottles, flasks, and CellSTACK Culture Chambers and, 96 and 384 microplates. For more details, contact: clsindia@corning.com Proteome Profiler Array launched US-based R&D Systems has introduced Human Phospho-Receptor Tyrosine Kinase (Phospho RTK) array kit for the parallel determination of the relative level of tyrosine phosphorylation of Receptor Tyrosine Kinases (RTKs). The Human Phospho-RTK array is a rapid, sensitive and economical tool used to simultaneously identify the relative levels of phosphorylation of 42 different RTKs. The development of protein array technology allows the screening of multiple proteins without performing numerous immunoprecipitation and/or western blot analyses. Each capture antibody is carefully validated by using lysate samples prepared from ligand-treated cell lines known to express the target receptor or cell lines transfected with a cDNA encoding a particular RTK. Recombinant tyrosine phosphorylated RTKs are used to validate capture antibodies when ligand-treated lysates were not available. The proteome profiler array is being distributed in India by Delhi-based Biotech India. For further details, contact: Info@BiotechIndia.com PerkinElmer launches BioXPRESSION biomarker platform PerkinElmer Inc., a leading provider in genetic screening, drug discovery, life science research, and analytical solutions, has launched BioXPRESSION biomarker discovery and screening platform. This BioXPRESSION platform provides a complete solution that can speed the discovery of biomarkers through its unique biomarker sample enrichment technology and highly accurate mass pattern recognition approach. The BioXPRESSION platform introduces new Proteomic Signature Technology (PST) that delivers high throughput and ultra-high mass accuracy and stability, resulting in comprehensive and high-confidence proteomic signatures. The BioXPRESSION Biomarker platform includes the novel prOTOF 2000 MALDI-TOF mass spectrometer, ProXPRESSION carrier protein-based blood biomarker enrichment kits and BAMF technology from Predictive Diagnostics, Inc. For more details, contact: sodhiak@labindia.com Cambrex Bio Science announces availability of gene expression data Cambrex Bio Science Walkersville, a subsidiary of Cambrex Corp., announced the availability of gene expression data and summary analyses for several primary human cell types. A comparison of the gene expression patterns between the undifferentiated and differentiated states revealed results that will aid in understanding the cell differentiation process and cell function. Additionally, new insights were uncovered in the difference between differentiated subcutaneous and visceral fat cells. In a collaborative effort with Paradigm Array Labs, a service unit of Icoria Inc., genetic expression profiles were generated and analyzed for Cambrex Bio Sciences Walkersville's Poietics Osteoclast Precursors, Subcutaneous Preadipocytes, and Visceral Preadipocytes before and after differentiation. The unique Poietics family of Cells and Media Systems coupled with recent advancements in transcript profiling provide biologists with efficient tools to further their understanding of the molecular events underlying cellular differentiation. Cambrex intends to expand the analysis to its broad offering of other cell types in its Poietics and Clonetics product lines in future projects with Paradigm Array Labs. For more details, contact: vivek.verma@cambrexindia.com ]]> <![CDATA[News Snippets]]> https://biospectrumindia.com/news/95/3245/news-snippets.html https://biospectrumindia.com/news/95/3245/news-snippets.html Thu, 07 Jul 2005 15:30:00 +0530 Ranbaxy's Goa plant gets MHRA approval The dosage forms manufacturing facility of Ranbaxy Laboratories Ltd in Goa has received approval from Medicines and Healthcare products Regulatory Agency (MHRA), UK, for its tablets manufacturing unit. Ranbaxy gets USFDA nod for anti retroviral drug Ranbaxy Laboratories has received a tentative approval from the US Food and Drug Administration (USFDA) to manufacture and market Lamivudine tablets, 150 mg. This is Ranbaxy's and India's first tentative approval from the USFDA under its expedited review process to support the PEPFAR (President's emergency plan for AIDS relief initiative). In combination with other anti retroviral agents (ARVs), Lamivudine tablets are indicated for the treatment of HIV infection. Commenting on this development, Dr Brian W Tempest, CEO and managing director, RLL, said, "We are pleased with the tentative approval for Lamivudine granted by the USFDA. This is a major step in making our life saving ARV medicines available to more and more HIV/AIDS patients in the developing world. We will continue with our efforts to obtain speedy approval for all our ARVs with the USFDA in support of PEPFAR. In tandem we are also pursuing WHO prequalification for the same products." Ranbaxy acquires Efarme's generic product portfolio Ranbaxy Laboratories has acquired a generic product portfolio accounting for 18 products belonging to the Spanish pharmaceutical company EFARMES, SA Unipersonal for sale in the Spanish market. The products belong to the Cardio Vascular System (CVS), Central Nervous System (CNS) and Pain Management segments. The agreement has been entered between Barcelona-based Laboratorios Ranbaxy SL, the wholly owned subsidiary of Ranbaxy and EFARMES of Spain. EFARMES is a leading company in the development of pharmaceutical products. Products are developed by EFARMES following its own understanding of market opportunities as well as on an exclusive, customized contract basis. Commenting on the development, Peter Burema, regional director Europe, CIS & Africa, Ranbaxy said, "We are happy to join hands with EFARMES. The acquisition fortifies our presence in Spain while augmenting our existing product portfolio." Transasia Bio-Medicals wins 'Most Promising SME' award Transasia Bio-Medicals Ltd has won two coveted awards in recognition of being India's Most Promising SME of the Year-2005. This award is an initiative to recognize the contribution of Small and Medium Enterprises (SMEs) towards the growth of the Indian economy. The CRISIL, who did the scrutiny of the businesses, received an overwhelming response from over 5000 SMEs from all parts of the country. The SME segment contributes 60 percent to India's GDP. Transasia's founder chairman and managing Director, Suresh Vazirani, received the award from KV Kamath, chairman, ICICI at a function in Mumbai recently. Distinguishing Transasia from the other 5000 aspirants, are its outstanding achievements. It is not only the leading diagnostic company in India, it has also made inroads into global markets with high technology diagnostic life saving products fully designed and manufactured in India, installed in more than 50 countries. Transasia's alliance with Japan's No.1 company Sysmex for global marketing of model 'CHEMIX-800, with the dual Transasia Sysmex logo, is a milestone for Indian technology manufacturers. The success has been built on the 25 year old strong foundation of investment in the best technology, research and development, commitment to quality and customer service. Zydus Cadila commences Phase I clinical trials on ZYH1 Zydus Cadila has received permission from the Drug Controller General of India (DCGI) to conduct Phase I clinical trials on its new molecular entity â€“ ZYH1. It may be recalled that Zydus Cadila had filed its first IND (Investigational New Drug) application for ZYH1 with the DCGI in January 2005. This novel agent for treatment of metabolic disorders has been designed and developed by Zydus Research Centre, the research wing of Zydus Cadila. The Phase I studies will focus on evaluating the safety profile of ZYH1. The clinical trials will be conducted at Zydus Research Centre that has capabilities to conduct Phase I clinical trials. "ZYH1 is expected to address the issue related to patients suffering from dyslipidemia in both diabetic and non-diabetic condition," said Dr BB Lohray, president, Zydus Research Centre. GE Healthcare, MediCity ink MoU for diagnostic and R&D facility The president and CEO of GE India, Scott R Bayman signed a Memorandum of Understanding (MoU) with Dr Naresh Trehan, chairman, MediCity in New Delhi to develop a diagnostic and R&D facility. The MoU between GE and Dr Trehan's MediCity, a $250 million world-class Integrated Healthcare Facility, was announced in the presence of Jeffrey R Immelt, chairman and CEO, GE and Kapil Sibal, minister of science and technology, Government of India. Under the MoU, GE India and MediCity will collaborate in a number of initiatives to create a medical institute of world standards specifically in the areas of high-end medical diagnostics, clinical research and development, utility services like power generation and distribution, lighting, water treatment and other environmentally friendly solutions. This is GE's first such collaborative venture worldwide and is also the first instance in Asia, where a leading technology provider has entered into a partnership with a center of excellence in healthcare services and research. MediCity, which has been envisioned as a multi-disciplinary high-tech medical institute spread over 43 acres in Gurgaon, and clinically modeled after global centers of excellence such as Johns Hopkins and Mayo Clinic in the US, is expected to be operational by 2007. Speaking on the occasion, Jeffrey Immelt said, "Our vision at GE Healthcare is to bring the latest healthcare technologies to India. Today, we've taken a giant leap in that direction by partnering with Dr Naresh Trehan and MediCity. At GE, we are increasing our focus on India. As India grows and flourishes on the world stage, I am enthused about India's growth potential and the exciting opportunities ahead for us. GE's commitment to India is unwavering, and we are here for the long-term." Dr Naresh Trehan, said, "The vision for MediCity is of a campus that is the epicenter for cutting edge medical research and innovation in Asia. MediCity will also be a strong demonstration of India's tremendous strengths in medical sciences to a global audience." Workshop on clinical research and CDM in July The fourth international workshop on Clinical Research and Clinical Data Management for Global Submission will be held on July 30-31 at Hotel LeMeridien, Pune. The workshop is being organized by Bioinformatics Center, University of Pune. German Remedies launches Betaferon for multiple sclerosis German Remedies, a part of the Zydus Group, has launched Interferon beta-1b under the brand name "Betaferon" for the first time in India for the treatment of multiple sclerosis. Betaferon is a subcutaneous injection and is the only Interferon efficacious even in the secondary progressive stages of multiple sclerosis. The product is being marketed in collaboration with Schering AG, Germany. Betaferon was launched in the US in 1993. This drug was a breakthrough effort in the treatment of multiple sclerosis. It is estimated that 1.5 million people suffer from multiple sclerosis worldwide. Betaferon is the top global product of Schering AG with over 2,00,000 patients on this treatment worldwide, registering sales of 780 million Euros in the year 2004. "The launch of Betaferon is yet another step towards a strong collaborative enterprise between Zydus and Schering AG in offering innovative healthcare therapies in the fields of female healthcare, cancer therapy and radiology," said J C Jani, executive director of Zydus Cadila and head of German Remedies. CCMB scientists create thermostable variant of lipase Scientists at the Centre for Cellular and Molecular Biology (CCMB) have reported an advance that has the potential to end the effective monopoly in the field of thermostable enzymes used by the Indian detergent industry. The work of the researchers focused on improving the stability of a lipase or a fat splitting enzyme even when exposed to high temperatures. The approach they followed was primarily based on deliberately generating large variations in gene sequences and picking up the desired variants by screening. This approach is called as "directed evolution". Unlike natural evolution that operates on the organism, this approach targets the protein itself. Their study, which has been published in the Journal of Molecular Biology, demonstrated that the approach of incorporating structural information during screening offers an sufficient and minimalist solution for the enhancement of a desired property of a protein and in addition suggests strategies for enhancing thermostability. ITRC signs MoU with Amity The Indian toxicology Research Centre (ITRC), Lucknow has entered an MoU with Amity for sharing and pooling of resources towards research and training, industrial development and for societal projects. The collaboration shall focus particularly in the areas of environmental management, standardization and quality control, commercialization of technology and for better conservation of natural resource in the country. The agreement was signed through the Amity School of Natural Resources and sustainable development, which already has a successful MoU with the National Botanical Research Institute (NBRI), Lucknow as well as several other leading government institutions. G BioSciences launches hands-on-training program in India G Biosciences, a US-based company involved in the development and manufacturing of proteomics products, has launched BioScience Excellence, a hands-on biotechnology training program for Indian students. The training for its first set of 20 students started at its facility in NOIDA. According to Dr Alam, CEO, G BioSciences, "Our educational kits supplement the education through hands on experience. It took us about two years to design the curriculum with inputs from teachers across the globe. We also plan to launch some interdisciplinary courses like regulatory compliance and IPR." India all set to become the new KPO hub: CII India is all set to move from being the most preferred business process outsourcing (BPO) destination to a knowledge process outsourcing (KPO) destination. A paper prepared by the Confederation of Indian Industry (CII) has revealed that KPO would grow at 46 percent to reach a staggering $17 billion by 2010. Besides, the study points that the growth of services sector would be more than 8 percent and its contribution to India's GDP would be more than 51 percent, affirming that India's transition from being a BPO destination to a KPO destination is imminent. According to the CII paper "India In The New Knowledge Economy", areas with significant potential for KPO include pharmaceuticals, biotechnology, and ICT, besides legal support, intellectual property research and design and development for automotive and aerospace industries. India stands to gain from its inherent strengths in the healthcare sector, pharmaceutical and biotech sector and ICT sector, it adds. According to the paper, India could emerge as a global KPO hub as the business requires specialized knowledge in respective verticals and the country's large number of engineering and technical institutes are geared to address the manpower demand. Indian pharma industry to grow from $6 b to $48 b by 2010 During the second meeting of the CII National Committee on Drugs and Pharmaceuticals 2004-05, an interactive session with Dr Montek Singh Ahluwalia, deputy chairman, Planning Commission, was organized. A presentation on global India Pharma Inc was made to Dr Ahluwalia focusing on the potential of the Indian pharmaceutical industry which was poised for growth from $6 billion to $48 billion by 2010. There was also a detailed discussion on the issues that the pharma industry is currently grappling with. The committee, led by Ajay Piramal, chairman, Nicholas Piramal India Limited urged for an increased spend on healthcare, liberalization of price control, Schedule M compliance for minimum manufacturing standards, OTC policy and implementation of recommendations of the Mashelkar Committee. The need for data protection, scaling up average expenditure on R&D, fostering public-private partnerships, increasing the capacity and capability in contract manufacturing and clinical trials was also reiterated. Orchid receives GLP certification Orchid Chemicals & Pharmaceuticals Ltd (Orchid) has received the Good Laboratory Practices (GLP) certification for its state-of-the-art R&D centre located in Chennai. This certification covers areas like physical-chemical testing, safety pharmacology and pharmacokinetic studies, toxicity studies, mutagenicity studies and analytical and clinical chemistry testing. Issued by the National GLP Monitoring Authority, this certification will provide a strong thrust to Orchid's ongoing new drug discovery (NDD) research programs. Orchid is driving growth through a twin strategy of catering to the expanding global generics market and fulfilling the need for enhanced new drug pipeline. As part of this strategy, apart from USFDA compliant generics formulation facilities, Orchid has established a new world-class drug discovery and development infrastructure. Orchid has end-to-end capabilities to develop and screen New Chemical Entities (NCEs) from the basic in-silico drug design to validation of compounds in various pre-clinical models. Prof. P Balaram is IISc director Prof. P Balaram, chairman, Division of Biological Sciences, Molecular Biophysics unit, Indian Institute of Science (IISc), has been appointed as director of IISc. Prof. Balaram, who started his career at the IISc as a lecturer in 1973, has held several positions in the Institute and has been honored with many awards and fellowships including the Padma Shri in 2002, the HK Firodia Award in 2003, the GD Birla Award for Scientific Research, the Jawaharlal Nehru Birth Centenary Visiting Fellowship (Indian National Science Academy) in 1996, the Mahendralal Sircar Prize (IACS, Calcutta) and the Goyal Prize in the Life Sciences category. He is also the Editor of Current Science and has been on the editorial board of science publications such as Journal of Peptide Research, International Journal of Peptide and Protein Research, Indian Journal of Biochemistry and Biophysics etc. Prof. Balaram has to his credit 364 research publications and one edited book. He has also been also associated with several government bodies and committees including the Basic Biology Task Force of the Department of Biotechnology (DBT), the Department of Science & Technology, the CSIR and the Science Advisory Committee to the Union Cabinet. Advanced Biochemicals to double its R&D expenditure Advanced Biochemicals Ltd, a leading industrial biotechnology company in India, has announced that it is increasing its total R&D expenditure in 2005-06 to 8.64 percent of its turnover as against 4.36 percent during the pervious year. The company has achieved some breakthrough in prevention therapy in its course of nutraceuticals research. Its nutraceutical research is targeted at tuberculosis, leprosy, obesity, cancer and cardiovascular diseases. It has set up an R&D lab in the pharma sector. It continues to focus on developing new enzymes-based customized products for food industry without any side effects. The products of Advanced Biochemicals have been analyzed and screened by competent regulatory organizations and have answered required qualitative tests. Advanced Biochemicals has come up with a product in its leather segment that helps in reducing the pollution as it reduces the usage of lime, sulphide and solvent. A product for sewage treatment has also been successfully developed and commercialized through Delhi Jal Board. ]]> <![CDATA[ICAR signs pact with IRRI in rice research]]> https://biospectrumindia.com/news/95/1522/icar-signs-pact-with-irri-in-rice-research.html https://biospectrumindia.com/news/95/1522/icar-signs-pact-with-irri-in-rice-research.html Thu, 07 Jul 2005 15:29:00 +0530 The Indian Council of Agricultural Research (ICAR) has signed a work-plan agreement (2005-2008) with the International Rice Research Institute (IRRI), Manila for collaboration in rice research. Both the organizations will cooperate in research areas of genetic resource conservation, evaluation, gene discovery, enhancing productivity and livelihood for fragile environments. Through this agreement, both the organizations will strengthen linkages between R&D, improvement and development of rain-fed rice, hybrid rice technology, biotechnology and rice-based cropping systems. ]]> <![CDATA[Life sciences companies need to leverage on IT]]> https://biospectrumindia.com/news/95/2584/life-sciences-companies-need-to-leverage-on-it.html https://biospectrumindia.com/news/95/2584/life-sciences-companies-need-to-leverage-on-it.html Thu, 07 Jul 2005 15:24:00 +0530 With increase in global and domestic competition and product patent in place, biotech and pharma companies have to improve their operational efficiency by adopting Sales Force Automation (SFA), an important business application and need adequate controls. Similarly R&D and clinical trials processes that have been technology enabled have to be secured to protect the intellectual property. Now the life sciences business is less about pills and potions and more about information. The new and direct role of IT is to turn intellectual assets to cash. So there is a need for multilevel collaboration between life sciences companies and IT vendors. This kind of partnership will help to address the future issues such as changing business models, new information dependencies, compliance and regulatory issues and shorter time to market felt the Chief Information Officers (CIOs) of leading biopharma and pharma companies at a panel discussion conducted RSA Security in Mumbai in association with Dataquest, a leading IT magazine, where BioSpectrum was knowledge partner for this seminar. RSA Security provides such solutions that address the central requirements of 21 CFR Part 11 like authentication, data integrity, confidentiality, audit trials, non repudiation, access control, unique electronic signatures that identify an individual. Addressing the delegates Ross Wilson of RSA Security said, "21 CFR Part 11 requires procedural controls (notification, training, SOPs, administration) and administrative controls to be put in place by the user in addition to the technical controls."   ]]> <![CDATA[Molecular Connections collaborates with Altana research institute]]> https://biospectrumindia.com/news/95/2765/molecular-connections-collaborates-with-altana-research-institute.html https://biospectrumindia.com/news/95/2765/molecular-connections-collaborates-with-altana-research-institute.html Thu, 07 Jul 2005 15:23:00 +0530 Molecular Connections (MC) has entered into a literature mining collaboration with Altana Research Institute (ARI), Boston, wherein it would mine thousands of papers and create customized target reports for ARI. The collaboration involves Molecular Connections' scientists working closely with scientists from ARI to identify and curate all the literature and public information available on genes affecting a specific disease condition. The comprehensive and structure information package created by MC is expected to help ARI scientists to identify, prioritize and validate the targets in a more effective fashion. As a part of the collaboration, MC would provide large number of "Target" reports. A target report will provide in a concise form information about various aspects of a given gene, i.e., whether they are assayable, what is their expression pattern, antibodies available etc. collated from vast number of papers published for those genes. ARI's scientists are applying the technology platform towards the identification of new therapeutic approaches for treatment of inflammatory and respiratory diseases, gastrointestinal disorders and cancer. Jignesh Bhate, CEO, Molecular Connections, said "Literature mining is our core strength and working closely with the ARI scientists we intend to deliver significant value to ARI's discovery efforts." The financial details of the collaboration were not disclosed. ]]> <![CDATA[Panacea introduces a novel anti-allergy drug]]> https://biospectrumindia.com/news/95/7406/panacea-introduces-a-novel-anti-allergy-drug.html https://biospectrumindia.com/news/95/7406/panacea-introduces-a-novel-anti-allergy-drug.html Thu, 07 Jul 2005 15:19:00 +0530 Panacea Biotec has launched Ralif (rupatadine 10 mg) a novel anti-allergy drug for the management of diseases with allergic inflammatory conditions, such as seasonal and perennial Allergic Rhinitis. According to Rajesh Jain, joint managing director, Panacea Biotec, "The introduction of new and novel therapies is an integral part of our continuous effort to provide innovative yet affordable drug therapies to the ailing humanity. Ralif has a dual mechanism of action which provides better relief from both allergy and associated inflammation whereas currently available molecules for Allergic Rhinitis have antihistaminic property only." Panacea Biotec is one of the leading health management companies in India involved in the research, production and marketing of pharmaceuticals, vaccines and biotechnology products. ]]> <![CDATA[Advanta buys 50% stake in Indian arm]]> https://biospectrumindia.com/news/95/1453/advanta-buys-50-stake-in-indian-arm.html https://biospectrumindia.com/news/95/1453/advanta-buys-50-stake-in-indian-arm.html Thu, 07 Jul 2005 15:18:00 +0530 dvanta Netherlands Holdings BV, the international seeds business owned by Fox Paine & Company LLC, has reached an agreement to buy 50 percent stake in Bangalore-based Advanta India Ltd, which is currently owned by its joint venture partner Agro Tech Foods Ltd. The transaction is subject to the receipt of regulatory clearance from the Indian authorities. Deepak Mullick Deepak Mullick, managing director, Advanta India said, "The company had been developing cutting edge agricultural technology for producing superior seeds for crops of national importance such as cereals and oilseeds." David Buckeridge, CEO, Advanta Netherlands Holdings BV said, "We regard India as one of the world's most important seed markets both in terms of its current size and its future potential for high quality seeds, genetics and associated high technology products. The Advanta India business is also very complimentary to the other seed business we have in the region, such as the leading businesses we own in Australia and Thailand." Dexter Paine, president, Fox Paine said, "We are focused on expanding the business in this strategic and high growth region. We are confident that Advanta India's innovative agricultural technology and leading market positions will continue to position the company for long-term success." Mullick further informed that the global seed industry is valued at $30 billion and that the Indian seeds market is estimated at $920 million. Advanta India is amongst the top five companies with International players such as Monsanto, Dupont Pioneer, Bayer Cropscience and Syngenta. ]]> <![CDATA[Boston Biologicals will focus on human health drug research]]> https://biospectrumindia.com/news/95/2634/boston-biologicals-will-focus-on-human-health-drug-research.html https://biospectrumindia.com/news/95/2634/boston-biologicals-will-focus-on-human-health-drug-research.html Thu, 07 Jul 2005 15:18:00 +0530 Prof. S Krishnaswamy Bangalore-based Animal Biotech (Bangalore) Pvt Ltd has launched Boston Biologicals, a separate entity focused in the human health arena. The company will focus on research and development in the areas of immunology- immuno-therapy, immuno-modulation and immuno-chemicals. "It will also undertake advanced research in drug delivery, tissue targeting, non specific immunomodulating molecules and antisense molecules in Bangalore," informed Prof. S Krishnaswamy, director, Boston Biologicals and Animal Biotech (Bangalore) Pvt Ltd. "The Bangalore facility will work on three drugs for disease segments of cancer, diabetes and arthritis," said Dr P Manivasakam, director, Boston Biologicals, who was here in India from Boston to oversee the launch of the new company. Efforts are on to hire scientists for its research program. At a later stage, the company will also develop monoclonal and polyclonal antibodies for diagnosis, therapy and research purposes. The company has attracted Prof. G Padmanabhan, former director of the Indian Institute of Science (IISc) as its scientific advisor and would be roping in a few more senior people informed Prof. Krishnaswamy. Explaining the reason for the diversification, Prof. Krishnaswamy, said, "Animal Biotech is a decade old company focused in the animal health biotech market, which is an expanding field. The focus there is on research and production of branded feed products and unbranded supplements in bulk, besides being engaged in bio-feed supplements for shrimps. The company is also pursuing its research and scale-up efforts of diagnostic kits. And Boston Biologicals will be focused on human health." ]]> <![CDATA[Clinigene, SCIREX to collaborate on clinical trials]]> https://biospectrumindia.com/news/95/1107/clinigene-scirex-to-collaborate-on-clinical-trials.html https://biospectrumindia.com/news/95/1107/clinigene-scirex-to-collaborate-on-clinical-trials.html Thu, 07 Jul 2005 15:11:00 +0530 Clinigene International, a wholly owned subsidiary of Biocon Ltd, and SCIREX Corp., a wholly owned subsidiary of the Omnicom Group, have Kiran Mazumdar-Shaw signed a Letter of Intent (LoI) to collaborate on global clinical trials. The LoI was signed at SCIREX's headquarters in Horsham, Pennsylvania, USA, during a recent visit by Kiran Mazumdar-Shaw, chairman and managing director, Biocon and Dr Arvind Atignal, chief operating officer, Clinigene. With India rapidly emerging as a key locale for clinical research, the new relationship provides SCIREX clients immediate access to well developed expertise in clinical investigation in India and provides Clinigene the opportunity to expand its markets and partake in global clinical trial programs. "SCIREX is extremely pleased to forge a new kind of exclusive partnership in India. We were a natural fit from the very beginning," said SCIREX CEO Jim Utterback. Shaw sees this partnership as a natural evolution for Clinigene and Biocon given the significant investment made over the past decade in systems, processes, and people. "We are proud of the leading role we have taken in India and look forward to enabling SCIREX's clients to benefit from the quality and speed of clinical development in India," she said. ]]> <![CDATA[CIMAP gets ISO 9001:2000 accreditation]]> https://biospectrumindia.com/news/95/2144/cimap-gets-iso-90012000-accreditation.html https://biospectrumindia.com/news/95/2144/cimap-gets-iso-90012000-accreditation.html Thu, 07 Jul 2005 14:55:00 +0530 The Central Institute of Medicinal and Aromatic Plants (CIMAP), Lucknow, has acquired ISO quality certification, becoming the only biological laboratory in CSIR to do so. The accreditation is being hailed as a remarkable achievement as it has become necessary for any organization to  Dr SPS Khanuja, director, CIMAP be certified for quality system. This is another feather in the cap of the institute as CIMAP is already certified by the NABL for chemical testing for the past eight years. CIMAP has been granted ISO 9001 license for quality management systems, which cover research and development, testing and analysis, process development, agrotechnology, production of quality medicinal and aromatic herbs, products and varieties and training in multidisciplinary research tools and cultivation and processing of medicinal and aromatic plants. ... Wins IDMS patent Appreciation award (2004) The Indian Drug manufacturer's association (IDMA) has recognized CIMAP's US patent on "Antimicrobial Composition" as the best patent in pharmaceutical biotechnology for their patent application award 2003-04. The patent is the result of concerted research in genomics approach for drug discovery by the team led by Dr SPS Khanuja, director, CIMAP. The award recognizes the novelty of approach at CIMAP in discovering new bioactive molecules by following the genomics approach to relate specific mutations conferring resistance in Mycobacterium and E coli like pathogenic bacteria against widely used antibiotics of the fluroquinolene group such as ciprofloxacin, norfloxacin, lomefloxacin and the parent molecule nalidixic acid. The research opens new avenues of searching novel drug molecules from plants and other sources with the capability to prevent drug resistance emergence in a combination mode. ]]> <![CDATA[Clinton favors proposed smart card for AIDS patients]]> https://biospectrumindia.com/news/95/1857/clinton-favors-proposed-smart-card-for-aids-patients.html https://biospectrumindia.com/news/95/1857/clinton-favors-proposed-smart-card-for-aids-patients.html Thu, 07 Jul 2005 14:53:00 +0530 "India is stunning the world with its achievements in technology and innovation, making over half the software of the world. I just saw the proposed smart card for dealing with HIV and AIDS patients, something that I think will become the norm for health records for every home, in every society of the world," stated Bill Clinton, former President of the United States of America and president, Clinton Foundation. Delivering his keynote address at the special plenary session of the National Conference on HIV/AIDS organized by the Confederation of Indian Industry (CII) in partnership with Indian Business Trust (IBT) and National AIDS Control Organisation (NACO), he said, "India has quite a challenge with AIDS but it is well within the country's ability to withstand." "Already in six states the disease has reached epidemic levels. HIV is much more than a health problem," stated Kapil Sibal, minister of state (independent charge) for science and technology and ocean development, while delivering his inaugural address during the first session of the conference. Elucidating on the success stories of Uganda and Thailand, Sibal stressed that projects on AIDS need proper funding, implementation and sustenance. The Smart Health Card for HIV /AIDS, the latest service offered by CII, was launched by Sibal during the conference. ]]> <![CDATA[Pfizer registers 62 percent growth in CDO services]]> https://biospectrumindia.com/news/95/1401/pfizer-registers-62-percent-growth-in-cdo-services.html https://biospectrumindia.com/news/95/1401/pfizer-registers-62-percent-growth-in-cdo-services.html Thu, 07 Jul 2005 14:47:00 +0530 Pfizer Ltd has registered a growth of 62 percent in the clinical development operations (CDO) services during the quarter ended May 31, 2005. The company has recorded revenue of Rs 6.64 crore from this service for quarter ending May 31, 2005 as against Rs 4.09 crore in the corresponding period last year. Pfizer has maintained a growth of 65 percent in clinical development operations during the first half of its financial year recording Rs 11.55 crore in revenues, an increase of Rs 4.56 crore over the corresponding period last year. ]]> <![CDATA[Gujarat announces draft biotech policy document]]> https://biospectrumindia.com/news/95/2669/gujarat-announces-draft-biotech-policy-document.html https://biospectrumindia.com/news/95/2669/gujarat-announces-draft-biotech-policy-document.html Thu, 07 Jul 2005 14:12:00 +0530 The government of Gujarat has come out with a draft biotechnology policy. Announcing this, chief minister of Gujarat, Narendra Modi, declared that the state government has prepared the draft biotechnology policy document, which highlights the state's vision, a strategic roadmap and a comprehensive incentive package to facilitate the overall development of biotechnology in Gujarat. Narendra Modi Chairing the Gujarat Council of Biotechnology meet held on June 14, 2005, Modi said, "The state is seriously considering creating HLA registry facilities for addressing the problem of blood related disorders like Thalassemia, which being in higher proportion in Gujarat, is a specific problem of the state. Gujarat should take the lead in stem cell research, as it is the present treatment option of many incurable diseases and a future technology for various health problems. The government is seriously considering establishing a cord blood bank in the state. Gujarat would be one of the very few states, in the entire country, to initiate work in this aspect." He further said, "The state has declared 2004-05 as Year of Urban development. And accordingly, the state would be using biotechnology for treatment and useful conversion of domestic effluents, in bigger cities like Ahmedabad and Surat. The state is considering starting a specific project for domestic effluent management as an exclusive model in urban planning. It would serve dual purpose. Apart from sanitization of waste, it would increase the availability of organic manure in bulk, thereby encouraging organic farming. The state is planning to establish a dedicated marine biotechnology institute to study and exploit the rich marine resources. The state has started a mission mode project on bio-diesel, involving university, forest department and CSMCRI. The state is keen to use biotechnology as a tool to augment and strengthen this approach." He declared that the state government is planning to establish bio fuel mission, which shall exclusively focus on bio energy. ]]> <![CDATA["Aquaculture production globally has been increasing on an average by 10% annually,"]]> https://biospectrumindia.com/news/95/8471/aquaculture-production-globally-has-been-increasing-on-an-average-by-10-annually.html https://biospectrumindia.com/news/95/8471/aquaculture-production-globally-has-been-increasing-on-an-average-by-10-annually.html Thu, 07 Jul 2005 13:55:00 +0530 says Dr Modadugu V Gupta. Dr Modadugu V Gupta, WorldFish scientist, who recently retired after a 15-year career with the Center, has been named winner of the $250,000 World Food Prize for bringing the Blue Revolution to those most in need through the expansion of aquaculture and fish farming in South and Southeast Asia and Africa. The World Food Prize will be formally presented to Dr Gupta at a ceremony on October 13, 2005 in the Iowa State Capitol Building in Des Moines. Dr Gupta shares his thoughts to BioSpectrum on what this Prize means to him. Dr Gupta hearty congratulations from BioSpectrum! What does being a World Food Prize Laureate mean to you? I feel that this award is a recognition of the importance of the aquaculture and fisheries to the nutritional security and livelihoods of poor in developing countries. I am happy to be the first person in the fisheries sector to be selected for such a prestigious and the highest award in food and agriculture and this gives me more impetus to work for the betterment of lives of rural poor farmers. What are the challenges of aquaculture today and how can the bar be raised? The world is looking forward to increased production from aquaculture (both freshwater and coastal aquaculture) to meet the increasing gap between supply and demand. Aquaculture production globally has been increasing on an average by 10 percent annually. While there are excellent opportunities for further increase, what is needed is the sustainability of these productions without degrading the environment. In the past, due to improper planning and implementation, there has been some damage to the environment, especially in the case of coastal aquaculture. All the stakeholders involved in the sector have to ensure that we undertake environmentally friendly aquaculture. Further, it might be necessary to look for species of fish and crustaceans that do not need animal protein in their feed as fishmeal that provides animal protein in the fish and livestock feeds is going to be in short supply in future. What is your impression about India in this context and how can India leverage on the vast coastline? India with its long coast has excellent opportunities for aquaculture. However, unplanned growth in 1990s has led to problems leading to closing down of some of the establishments. Having learnt the lesson, it is time for the industry to change their management styles. Further, while shrimp production globally is on the increase, the demand has not increased resulting in heavy competition in the market. To compete in the high-end markets such as Europe, our exporters have to follow strict quality controls. What is your message to the Indian scientists? India has large number of excellent scientists and well-equipped research institutions. However, in recent years, we have lost edge as compared to some of the countries in the region in the field of aquaculture. My message to Indian scientists is that they should undertake research that is relevant to the industry as otherwise the industry will lose confidence in them and investments made in research will go waste. Ch. Srinivas Rao ]]> <![CDATA["Investments made in the access labs offering validation and process development services have paid off,"]]> https://biospectrumindia.com/news/95/2020/investments-made-in-the-access-labs-offering-validation-and-process-development-services-have-paid-off.html https://biospectrumindia.com/news/95/2020/investments-made-in-the-access-labs-offering-validation-and-process-development-services-have-paid-off.html Thu, 07 Jul 2005 13:54:00 +0530 - Sudhir Kant, CEO of Millipore India When was the bioscience division created? The lab water division and the life science division were merged into a single new division called bioscience division on February 18 this year to unlock organizational and operational synergies for the benefit of our customers. This division, combining the strengths of the erstwhile divisions, has increased the quality, width and depth of our market coverage to focus on the diverse and growing needs of the customers with more value-added solutions. Leveraging the technical capabilities of both the talented teams has benefited our customers by accelerating their pace of innovations. Refocused resources and organizational fitness has also helped us partner with our customers with more dynamism. And the team continues to drive our "leading from the future" business philosophy, a belief that has helped us remain in the forefront for more than 50 years. What have been the other initiatives of Millipore India? We created a new group called the PMT (Process Monitoring Group) within the biopharmaceutical division in response to customers increasingly seeking our expertise in this area. The new chairman and CEO of Millipore Corporation, Martin Madaus visited Millipore India. He was impressed enough by the Indian operations to assign several new initiatives in the areas of manufacturing and research. These should be operationally ready by the end of 2006-beginning 2007. The investments made in the access labs offering validation and process development services paid off with some of the major pharmaceutical and biotechnology majors utilizing our world class facilities and services. Customers benefited from this facility, as they need not go to similar facilities in Europe or the US for such requirements now. The order position is so healthy that we are in the process of expanding by recruiting more validation and process development experts. In February this year, Millipore co-hosted along with the All India Drug Control Officers Confederation (AIDCOC) a very successful and well-received workshop on aseptic processing. It was attended by over 130 pharma professionals and drug regulators. What are the highlights this year? Millipore's investments in people, the most important asset in the high technology areas we operate in, continued with our nationwide strength touching 180 personnel. Most of the new people will be deployed in validation, process development, customer support, service and in manufacturing operations. We introduced several new innovative products and technologies during the year for biopharmaceutical and life science applications and results from the company's concerted efforts in Bangladesh, Nepal and Sri Lanka have started to yield results. An IT project, which integrates our databases with that of Millipore Corporation, was successfully implemented. This gives us access to the knowledge base and experience of more than 35 countries around the Millipore world. We also signed new business agreements with leading scientific and research institutions and marketing companies in the areas of biotechnology and life sciences. Namratha Jagtap ]]> <![CDATA["The industry can grow bigger than what it is now"]]> https://biospectrumindia.com/news/95/2742/the-industry-can-grow-bigger-than-what-it-is-now.html https://biospectrumindia.com/news/95/2742/the-industry-can-grow-bigger-than-what-it-is-now.html Thu, 07 Jul 2005 13:13:00 +0530 - Steve Vadehra, VP, international operations, Kewaunee Scientific Corporation What are Kewaunee's expansion plans in India? Kewaunee has brought in world-class laboratory technology to India in 2000 and since then we have done about 50-60 projects in India. Before that there was no benchmark in the industry and people did not know what a true lab should look like. Now, there is that understanding in the market. We started small and we didn't think at that time that India would be such a growth market for us in this area. But we are pleasantly surprised at the growth. We set up some manufacturing two years ago mainly for the domestic market. Later this year, we are looking to export some of the products manufactured here to the international market starting with South Asia. The cost of lab equipment is a constraint to start-ups. What are your views on that? I haven't seen the government giving any incentives or concessions on duties on equipment to companies that want to come in. So cost would definitely be one of the constraints for the growth of the industry. What do you think about the growth track of the Indian biotech industry since you came here? We have been in India for five years now and we have seen tremendous growth. We believe there is a lot of opportunity especially after the new patent law was passed. We will see more investments in this sector in India. What we have seen in India is that the industry is mostly driven by contract research. Majority of it has been in the chemical synthesis and research in the pharma area and biotech is still on the smaller side. But we believe that biotechnology has a bigger future. A lot of Indian companies are scaling up and expanding and besides, a lot of companies abroad want to come to India. Growth is definitely there because it started from scratch. But it is still smaller compared what it could be. We believe that it is going to be much larger than what it is right now. Priya Padmanabhan CyberMedia News, Bangalore ]]> <![CDATA[BioEvent July 2005]]> https://biospectrumindia.com/news/95/1333/bioevent-july-2005.html https://biospectrumindia.com/news/95/1333/bioevent-july-2005.html Thu, 07 Jul 2005 13:12:00 +0530 Stem Cells: Premises & Promises The National Institute for Research Health, Indian Council of Medical Research, Indian Society for the Study of Reproduction and Fertility and Histostem, Inc., USA, will conduct an international symposium on "Stem Cells: Premises & Promises for Research & Therapeutics", in Mumbai on September 18-21, 2005. The symposium will be an interactive forum for scientists involved in stem cell research to deliberate on the current scenario and identify future directions for research and therapeutic applications. The symposium would also serve as a platform to enhance awareness of the advances in stem cell research among the scientific community, to develop interactions between the scientists, and to establish linkages with national and international institutions working in the area. The major and pivotal problem of ethical issues concerning embryonic stem cells and therapeutic cloning will also be deliberated to evolve national policies. The symposium will be a Satellite to the meeting of the Global Forum for Health Research, being held in Mumbai during September 12-16, 2005. For more details, contact Dr Deepa Bhartiya or Dr KVR Reddy. E-mail: stemcells@indiatimes.com; stemcells@rediffmail.com, Tel.: +91-22-24137730/24165267. Drug Discovery to Clinical Trials IBC Life Sciences will organize Drug Discovery to Clinical Trials conference on October 5-7, 2005 in Mumbai. The meet will feature a session on the "Current Status of Intellectual Property Rights in Asia" and a panel discussion on "Moving from a Fee-for-Service/CRO Model to an Innovation Model in India and China: Challenges and Opportunities". Proposals for poster presentations at the event on scientific and business topics are currently being accepted and the deadline is September 14, 2005. For more details, contact: enquiry@ibcasia.com.sg Pharma Expo 2005 Pharma Expo 2005, the second edition of international pharmaceutical exhibition and conference organised by the Confederation of Indian Industry (CII), will be held on October 20-22, 2005 in Mumbai. The three-day event will bring together the manufacturers and suppliers of process, plant and equipment for the growing pharmaceutical industry. As a dedicated platform for the pharmaceutical manufacturing industry, the exhibition will provide a great opportunity for service providers to showcase their products and services to decision makers. Pharma Expo 2005 will deliver national and international industry professionals from plant and equipment for pharma production; packaging machinery and materials; lab equipment, analytical instruments, labware; process control and instrumentation; effluent treatment and waste management systems; refrigeration, cold rooms, cleanrooms; bulk drugs, drug intermediates; excipients, additives etc. For details, contact: anil.padwal@ciionline.org Certificate course on clinical research The Academy for Clinical Excellence (ACE), Mumbai will conduct "Clinical Research - From Theory to Practice", a two-day certificate course on July 29-30, 2005. For registration form and other details, contact Aditi (course co-ordinator) on +91-22-26671032/26664568, e-mail: acebcp@eth.net, acebcp@yahoo.com BioProcess International BioProcess International Asia Pacific, an international biopharmaceutical/biologics development, production and manufacturing conference will be held in Singapore on November 7-9, 2005. The 3-day conference will provide critical information on the biopharmaceuticals production and development industry, that spans across 10 Asia Pacific countries, specially addressing the needs of US, European and Asia Pacific regional executives and scientists who are looking for global alliances and technological innovations, as well as ways to improve their bioprocessing capabilities and skills. For more details, contact: enquiry@ibcasia.com.sg Pharmaceutical Regulatory Affairs meet Pharmaceutical Regulatory Affairs meet will be conducted on September 26-27 in Singapore. The meeting will give an overview and introduction to pharmaceutical regulatory affairs in the major markets in Asia. It would also discuss regulatory procedures and requirements for the approval, particularly of new pharmaceutical products, clinical trials needs and opportunities and optimal regulatory strategies. Participants will receive a certificate of attendance on the concluding day of the meet. For more details, contact: enquiry@ibcasia.com.sg BioThailand 2005 BioThailand 2005 will be organized at The Queen Sirikit National Convention Center in Bangkok on November 2-5, 2005. The event is expected to be one of the main regional events focusing on updating the academic, research and industrial communities on new innovation and discovery from around the world, as well as to promote the bio-business opportunity in Thailand and the region. Scientific meetings which will be held as part of BioThailand 2005, will include conferences and sessions on bionanotechnology, biosafety, bioresource information management and shrimp biotechnology. The symposia will consist of oral and poster presentations. BioThailand 2005 trade exhibition will be held concurrently with the scientific meetings, involving exhibitors in various sectors such as agriculture, pharmacology, medicine, environmental engineering and more. For more details, contact: biothailand2005@biotec.or.th 12th European Congress on Biotechnology The 12th European Congress on Biotechnology (ECB12) will be held on August 21-24, 2005 at Copenhagen, Denmark. ECB12 will address cutting edge research in the fields of modern biology and biotechnology under the theme 'Bringing Genomes to Life'. The scientific program will include symposia on genomics, proteomics and protein engineering, environmental biotechnology, food biotechnology and industrial biotechnology. The event will introduce to participants high quality, front line research presented by European and international speakers and create a meeting place for academia and industry in the field of biotechnology. For more details, contact: lhp@bio.auc.dk PABORD 2005 PABORD 2005, a pharmaceutical and biotech outsourcing, research and development exhibition and conference, will be held in London on September 14-15, 2005. The event will focus exclusively on the theme of outsourcing in the research and development of new medicines. Companies both large and small are adopting this increasingly popular business strategy. The conference is relevant to service providers and R&D organizations active across the entire discovery and development chain from lead generation to product registration. For more details, contact: info@pabord.com BIO Mid-America VentureForum 2005 The 2005 BIO Mid-America VentureForum will be held in Minneapolis-St Paul, on September 21-23, 2005 at the Hilton Hotel, Minneapolis, USA. The Midwest's largest annual event will showcase biotech and medical device product and platform companies from across the country. The event will provide a platform for venture capitalists, start-up biotech and medical device entrepreneurs, and other industry participants to meet and explore funding and investment opportunities and forge business partnerships. For more details, contact: BIOMidAmerica@bio.org BIO InvestorForum 2005 BIO InvestorForum 2005 will be organized on October 19â€“20, 2005 at The Palace Hotel, San Francisco, CA. Hosted by BIO, the largest industry organization focused exclusively on biotechnology, BIO InvestorForum 2005 will bring together industry investors with the management of top life sciences growth companies, as well as the companies poised to join the growth "watch list" for 2006. For more details, contact: bioinvestorforum@bio.org Protein Symposium 2005 The Protein Society will organize the 19th Annual Symposium on July 30-August 3, 2005 in Boston, Massachusetts. The symposium will feature over 50 invited speakers and will include sessions on protein-ligand interactions, the assembly and function of molecular machines, protein misfolding and amyloid formation, protein engineering and design. Three special sessions on systems biology will be offered including an opening plenary session and two award plenary sessions. On the occasion, the 2005 Stein and Moore Award will be jointly presented to Dr Avram Hershko (Technion - Israel Institute of Technology) and Dr Alexander Varshavsky (California Institute of Technology) for their revolutionary work in discovering the ubiquitin system of protein degradation, its mechanisms, and its significance to living cells. For more details, contact: protein05@faseb.org 12th Annual Chips to Hits IBC Life Sciences will organize the 12th Annual Chips to Hits, a comprehensive event on microarrays and mictrotechnology on September 12-15, 2005 at the Boston Convention & Expo Center, Boston, MA. The conference will cover the entire microarray spectrum from the latest emerging technologies to nearly commercialized products that are soon to be released for prime time all the way through to validated case studies of applications that are currently implemented. Speakers will present data, case studies and strategies organized in four different subject tracks, including FDA & government perspectives'. Over 70 industry leaders are expected to attend the conference. For more details, contact: reg@ibcusa.com 11th International Congress of Human Genetics The 11th International Congress of Human Genetics will be held on August 6-10, 2006 at Brisbane, AU Australia. The International Congress of Human Genetics is the foremost meeting of the world human genetics community and is held every five years. The Congress is organized on behalf of the International Federation of Human Genetics Societies (IFHGS) and in 2006, the host will be the Human Genetics Society of Australasia. By 2006 the tangible impact on human health of the Human Genome Project and advances in genomic science and biotechnology will make attendance at the 11th Congress essential for health professionals and genetic scientists alike. For more details, contact: ichg2006@icms.com.au ]]> <![CDATA[Transgenic crops catch BIO fancy]]> https://biospectrumindia.com/news/95/2101/transgenic-crops-catch-bio-fancy.html https://biospectrumindia.com/news/95/2101/transgenic-crops-catch-bio-fancy.html Thu, 07 Jul 2005 13:09:00 +0530 The annual biotechnology convention, BIO, is usually dominated by the biopharma sector. It is the vaccines and therapeutics that receive global attention when the biotechnology community congregates annually in the US, for the past 12 years. The 13th edition of BIO in Philadelphia made an attempt to focus on genetically-modified (GM) crops and it was a huge success. The world's first GM crop was introduced 10 years ago. During a lively discussion, it was pointed out that from China to Brazil and from the US to South Africa, farmers around the world who choose biotech crops do so because they perform better than the alternatives. Some highlights of 10 years of Green Biotechnology, compiled by the US Grains Council: In China, farmers producing biotech cotton have been able to eliminate two-thirds of their insecticide use. Farmers in the US and Argentina give credit to green biotech because it has made it easier for them to implement soil-friendly cultivation practices that reduce erosion in their fields and help protect precious top soil Biotech cotton has increased yields and net income for small farmers in many countries including South Africa, India and China. In 2004, farmers increased biotech crop production 200 percent in Uruguay, 66 percent in Brazil and 32 percent in China. Globally, biotech crops represent 56 percent of all soybeans, 21 percent of cotton, 19 percent of canola and 14 percent of maize. More than 60 countries are now doing research on 50-plus different crops that are important to their farmers, their cultures, their economies and their security. " In the biotech century ( 21st Century), using genetically enhanced crops, we will feed an increasingly hungry world," noted BIO President Jim Greenwood in his opening remarks. " In the biotech century we will harness enzymes to convert plant waste to fuel and biodegradable plastics, reducing our dependence on oil." Biotech agriculture is spreading worldwide quickly. While North America is the epicenter of plant biotech research, more than half the 63 countries engaged in biotech research, development and production are developing countries. South Africa is a noted example. It has already approved biotech varieties of corn, cotton and soybeans for planting and now ranks sixth in the world in terms of the number of acres planted with biotech varieties. According to an NGO, Africa Bio, in Africa only South Africa is growing GM crops commercially now, but Zimbabwe, Egypt, Kenya and Burkina Faso have started with field trials. " I have grown Bt maize, seen the benefits and our community and chicken have consumed it without any ill effects," said Sabina Khoza, secretary-general, National African Farmers Union, South Africa. Debunking fears that farmers may become captive to foreign companies, Africa Bio pointed out that new protection systems are being developed to protect farmers' historic rights in conservation and use of varieties as well as the indigenous knowledge associated with it. In South Africa, plant varieties cannot be patented. Only the specific gene insertion is patentable. In most cases, the foreign companies own the patented gene, but other breeders, also South Africans, own the variety. IT is government policy to develop local technologies. There were many interesting sessions on this topic. There was a specific session to discuss the impact of GM crops in developing countries. And all the three presentations were from India: KK Narayanan of Metahelix, Bangalore, V Moreno of Avesthagen, Bangalore and Alok Kumar of Monsanto India. " Over 1.3 million acres (0.5 million hectares) of Bt cotton has been planted in India within three years of its commercial introduction. No other agriculture technology has seen such quick and massive adaptation in human history," informed Metahelix's KK Narayanan. He made a strong plea to the global community to look at India seriously as the country has to adapt the latest technologies to push up the productivity of the largest cultivable area in the world and produce an extra 40 million tons of foodgrains from declining land area to feed the citizens. Farmer Edwin Paraluman in Indonesia is another farmer who has benefited from Bt maize. After switching to the GM variety, he was offered 8 pesos per kg of corn, well above the going rate of 7.4 pesos per kg. Also, the biotech corn had double the yields-2.8 tons per acre instead of 1.4 tons per acre - he had been averaging with conventional hybrid corn. "You know for me, it's really amazing," said Paraluman in a study by the Council for Biotechnology Information. This is for the first time in my life that I can actually get ahead and provide a better life for my family." ]]> <![CDATA[India-US biotech ties inch closer]]> https://biospectrumindia.com/news/95/2578/india-us-biotech-ties-inch-closer.html https://biospectrumindia.com/news/95/2578/india-us-biotech-ties-inch-closer.html Thu, 07 Jul 2005 13:07:00 +0530 It began in a small way. The cooperation between the US and India in high technology area, particularly biotechnology, has been increasing steadily. It was most evident in June meeting of the Indo-US High Technology Cooperation Group (HTCG) in Washington DC in mid-June. Easing of restrictions for the transfer of biological materials from the US to India and the need for data exclusivity in clinical trials of drugs in India dominated the discussions. An exclusive report from Washington DC by BioSpectrum Editor Narayanan Suresh Since the signing of the agreement between the then Prime Minister A B Vajpayee and US President George Bush in 2001, the biotechnology sector, one of the four chosen areas, has pushed the friendship ties very well. A number of issues identified for action between the two government have been completed and it was time to pick out more issues for implementation. "I don't want even want to mention the word intellectual property right (IPR) as all the demands have been met and is no longer an issue," remarked Krishna M Ella, co-ordinator of the program from FICCI on the Indian side during his opening statement. "Let us move on to other substantial issues." The who's who of Indian biotech was around to represent India: Science and technology minister, Kapil Sibal, Department of Biotechnology secretary M K Bhan, FICCI's Ella and CII's Gautam Thapar and Hari S Bhartia. The US heavyweights were David A Sampson, acting deputy secretary, US Department of commerce, Benjamin Wu, Assistant Secretary for technology policy, US Department of Commerce, Ron Somers, president, US India Business Council and Lt Gen (retd) Daniel Christman, senior VP, US Chamber of Commerce. With IPR issue out of the way, Sibal and Bhan stressed the need for the US to liberalize the biological materials transfer arrangements which was standing in the way of India getting crucial biological materials for research and development. "We understand the US concerns over this due to the dual use possibilities in biological warfare. We are willing to set up all the safeguards and export controls and transfer these materials safely to researchers," stressed minister Sibal. "Let us collaborate to enable India become the vaccine maker of the world. We already have the advantage in this sector. We have the capacity and capability to provide the world with all the vaccines it needs, cost effectively." Sibal reiterated that India was bound to become the clinical trial hub of the world. This would help reduce the astronomically high cost of drug development ($800 million to $1.2 billion) by at least a third and help the middle class in the US too. "We need the US regulator (FDA) to tell us what protocols are needed to enable acceptance of trial data done in India. And train our people also in this field," Sibal emphasized. US minister David Sampson said India's new entrepreneurship system was increasingly engaging with the US side. He pointed out that US has relaxed the high tech export control regime to India since 2003 and the US was keen to increase the investments in the country. For this the investment rules have to be more transparent and predictable. Dr Bhan highlighted the policy measures that seek to reduce the time for various regulatory clearances, 100 percent FDI in biotech, and the government policy to set up 20 globally recognized clinical research centers in India. A massive overhaul of the scientific research system in India was underway and it was crucial for India and US to work together to make it happen efficiently. The meeting was attended by over 150 people from both sides, which was one of the largest such gathering between the two countries. The cooperation has certainly moved to the next level, and the development of Bangalore as a major center of innovation was highlighted by speakers from both sides. ]]> <![CDATA[Biotech fights cancer]]> https://biospectrumindia.com/news/95/1295/biotech-fights-cancer.html https://biospectrumindia.com/news/95/1295/biotech-fights-cancer.html Thu, 07 Jul 2005 13:04:00 +0530 Biotechnology may become the latest ally of humans in fight ing its age-old enemy: cancer. A host of new drugs from the biotechnology sector are aiming to use the body's own cellular processes to halt growth of cancerous cells. "The new generation of cancer medicines will be those that target genetics," said Dr Carl June, professor, Abramson Family Cancer Research Institute, University of Pennsylvania, while moderating a special discussion on cancer drugs at a media brunch featuring cancer-fighting food during the BIO convention in Philadelphia on June 19. "There is hope," said BIO president Jim Greenwood. He noted that 29 biotech drugs that fight cancer are in the market now and more are in clinical pipelines. Biotech leaders are confident that biologic drugs will someday overtake standard chemotherapy treatment, said June. "Unfortunately, it takes longer than we would like." Promising Drugs The results of some of the new generation cancer-fighting drugs show promise. One such experimental drug is called MDX-010, developed by Medarex, Princeton. The drug is currently undergoing late stage human trials. MDX-10 is an antibody designed to help patients with advanced metastatic melanoma cancer to fight it with strong immune response. Medarex CEO Donald L Drakeman said the trials have shows some dramatic results with six of the 29 patients recording shrinkage or disappearance of the tumor cells. These patients had received a higher dosage of the drug. In patients with such advanced cancer, even the conventional chemotherapy works only five percent of the cases and that too for six weeks. "In one patient with the cancer spreading to lung and brain, the MDX-10 treatment enabled to prolong life for 30 months. This is really makes the drug exciting," Drakeman informed. In other cases, three of the 27 patients experienced partial responses, with two of them responding to the treatment to live for 25 and 26 months. MDX-010 is a fully human antibody against human CTLA-4, a molecule on T cells that is believed to be responsible for suppressing the immune response. Medarex focuses on the discovery and development of fully human anti-body based therapeutics to treat life-threatening and debilitating diseases, including cancer, inflammation, autoimmune disorders. Another promising treatment is from Cell Genesys of San Franciso. Cell Genesys CEO Stephen Sherwin said the company has developed a GVAX anti-cancer vaccine which is designed to stimulate the body's immune system. In one trial, cancer patients receiving GVAX had experienced a median survival rate of 26 months, eight months longer than chemotherapy-only patients. The vaccine has been granted fast track clearance for phase 3 trials to treat patients with prostate cancer. A lot of such promising drugs are under development. The problem, Sherwin said, was that it would take a lot more time to develop them fully. "The investment community is not really interested in investing in new therapies in the development stage because they don't know if they will succeed," he commented. Human side of cancer Richard Roundtree is a popular actor in the ongoing serial "Desperate Housewives". Nearly 12 years ago, three simple words from his doctor hit him like a ton of bricks. "You have cancer," the doctor told him. Roundtree couldn't believe that even a man would get breast cancer. Rountree narrated his fight to become cancer-free as he was now. Someone is diagnosed with breast cancer in the world every three minutes and every 13 minutes someone dies from the disease. "We are in a war, a war against a vicious enemy without regard for age, sex or social position," Roundtree said. "This is a war that must be fought by all of us." Roundtree has been at the forefront of cancer education. His advice: Be alert to symptoms and get an early diagnosis, eat health foods, and exercise. "There are points in our lives where we are given another chance. I was," he said. " It is a message of empowerment. A message letting people know they have the ability to lessen the risk that cancer will be a part of their health history." There were other high-profile cancer fighters at BIO. Fox News commentator Morton M Kondracke, whose wife died of cancer five years ago, has been a tireless crusader against cancer. "Cancer needs a tough fight. You are doing God's work by developing drugs that fight cancer," Kondracke told the biotech industry leaders. "Carry on." Another touch of glamor came in the form of popular rock singer, Melissa Etheridge, who recounted her year-long fight with breast cancer. Praising the biotech industry for developing drugs to eliminate the " barbaric treatment of cheomotherapy involving washing one's body insides with chemical acids" she narrated her sufferings. "There is no shame in having cancer. Don't hide it from friends," said the actress highlighting her decision to appear at this year's Grammy awards for a special performance, with her bald pate. " I threw away the scarf. What is there to hide," recalled Etheridge.     Cancer-fighting Foods The National Cancer Institute of the US estimates that one-third of all cancer deaths may be diet-related. Although nutritionists do not understand exactly how foods can prevent and treat various cancers, they agree unanimously that diets high in vegetables and fruits can reduce the risk of contracting certain cancers. If people increase their fruit and vegetable consumption to at least five servings a day, cancer rates could be reduced by 20 percent, studies show. And the media brunch at the BIO convention on June 19, featured a menu of cancer-fighting foods. The menu : Spinach and avocado salad Spinach and avocado salad with grapefruit sections and mandarin oranges, roasted pecans (nuts) with honey and molasses (jaggery), garnished with sprouted flax and balsamic vinaigrette. Grilled chicken breast in a tomato cream sauce Grilled chicken breast served with long grain rice, sundried cherries and toasted pistachios, in a chili-peppered tomato cream sauce. Served with broccoli florets and julienne carrots Fruit parfaits Blueberries, raspberries, blackberries and strawberries layered with yogurt and granola Beverages Selection of fruit juices including grapefruit, blueberry, apple, cranberry, prune and grape juice or soy milk How these foods fight cancer: Avocados are rich in glutathione, a powerful antioxidant that attacks free radicals in the body by blocking intestinal absorption of certain fats. Blueberries: Studies have shown that just one club of blueberries provide all the disease-fighting antioxidants needed in a a single day. Broccoli contains the chemical component of indole-3-carbinol and the phytochemcial sulforaphane, which both have cancer-fighting properties. Carrots are rich in beta-carotene, which may help reduce a wide range of cancers, including lung, mouth, throat, stomach, intestine, bladder, prostate and breast cancer. Chili peppers contain a chemical capsaicin, which may neutralize certain-cancer causing substances. Flax contains lignans which may have an antioxidant effect and block or suppress cancerous changes. Grapefruits contain monterpenes, believed to help prevent cancer by sweeping carcinogens out of the body. Grapes (red) contain bioflavonoids, powerful antioxidants that work as cancer preventives. Oranges contain limonene which stimulates cancer-killing immune cells that may also breakdown cancer-causing substances. Raspberries contain many vitamins, minerals, plant compounds and antioxidiants know as anthocyanins that may protect against cancer. Soy products like tofu contain several types of phytoestrogens - weak, nonsteroidal estrogens that could help prevent cancer by blocking and suppressing cancerous changes. Spinach contains cartenoid that help fight prostate cancer Tomato has lycopene which may help prevent and treat prostate cancer. ]]> <![CDATA[Indian biotech shines bright at BIO 2005]]> https://biospectrumindia.com/news/95/2611/indian-biotech-shines-bright-at-bio-2005.html https://biospectrumindia.com/news/95/2611/indian-biotech-shines-bright-at-bio-2005.html Thu, 07 Jul 2005 13:03:00 +0530 Indian biotech shines bright at BIO 2005 Both BIO and India have truly arrived at Philadelphia in June 2005. When the fourth annual convention of the Biotechnology Industry Organization (BIO) was held for the first time in Philadelphia in 1996, there were just 3,000 visitors including a handful of Indians. The 13th edition which returned to the city where the US as we know was founded in the 17th century, it was different. There were over 18,000 participants and India was truly the flavor of the event. Sheer numbers don't tell the tale. There was a contingent of 50 Indian biotech business leaders under the CII umbrella, led by S&T Minister Kapil Sibal and a fairly big Indian pavilion at the trade exhibition. There weren't too many sessions where India was not mentioned. Almost every speaker in every session referred to the biotech developments catching up in India and China and how the US biotech sector, which still accounts for 80 percent of the global revenues, should begin to engage India. Is the global biotech market shifting to India and China? Stelios Papadopoulos, vice chairman of SG Cowen & Co was asked specifically at a plenary session, The Mating Game - Finding and Nurturing Partners. "Not yet. But it is on the way," he replied. "The process will quicken based on how some test cases on IPR violations are dealt with. But the real challenges are economic in nature and not regulation or policy. It will depend on the demand growth for drugs here." The Indian flavor was evident at the inaugural session of BIO on June 19. The first session, "Scenarios for the Future of BioSciences: Global Challenges and Opportunities in the Coming Decade," opened with a strong plea by ABLE President Kiran Mazumdar-Shaw to the biotech sector to look to India for partnership to lower the drug development costs, speed up time to market and provide affordable medicines to the whole world. Her argument: The US regulator should permit at least 20 percent of the clinical trials of all new drugs to be done in India under global standards. This would dramatically lower the drug developments costs and time. The session was followed by a global health symposium. Two of the five speakers were Indians. Mazumdar-Shaw and DBT secretary, Dr M K Bhan. The DBT chief made full use of the global forum to present India's case as the emerging global hub for vaccine. India was prepared to meet all the regulatory and other requirement to make this happen and urged the US regulators to help India upgrade its systems and infrastructure to supply essential vaccines to the world. A 90-minute country seminar on India was overcrowded and had attendees squatting on every nook and corner and craning their necks from every angle to catch every word of a spell-binding articulation of India's case by S&T Minister Kapil Sibal. Health should be a development issue. And the neglected diseases of the world actually offer a big market even for the giant pharma companies, he said, provided the drug developments costs are reduced dramatically. India is the best place to make this happen, he said. And it will not only benefit the poor people of the world but and the 70 million middle class American who are not able to afford key medicines now, Sibal said. "Come to India. You will be able to develop the best drugs at the lowest prices with the best quality," he said amidst thunderous applause. Sibal got the opportunity to reiterate the same message at the international ministerial conference attended by ministers from Australia, Hungary and Canada. India indeed occupied the high table at the BIO 2005. There were two other major sessions dominated by Indian participants. The session on the use of bioinformatics was monopolized by Indians: Vijay Chandru of Strand Life Sciences (renamed from Strand Genomics), M Vidyasagar of TCS, Dr Samir Brahmachari of IGIB and Prashant Naik of Jubilant Biosys. "Why were all speakers Indians," queried a journalist. "It just happened that way and not by design," muttered Vidyasagar. Similarly, three Indians - KK Narayanan of Metahelix, Alok Kumar of Monsanto and V Moreno of Avesthagen - dominated that discussion on the experience of growing transgenic corps from developing countries. The Indian Pavilion at the trade show as visited by hundreds of participants and the India Biotechnology Handbook 2005, brought out by BioSpectrum for the Department of Biotehcnology (DBT) was much sought after in the BIO meetings. Thousands of copies were picked by BIO participants who came to the India pavilion looking for information about the $1 billion Indian biotechnology sector. TCS, Karnataka government, Biocon, Genome Valley and ABLE stalls at the BIO exhibition received hundreds of inquiries. Indian biotech has indeed arrived at the global scene in Philadelphia. Narayanan Suresh in Philadelphia ]]> <![CDATA[Wanted A Bayh-Dole Act for India]]> https://biospectrumindia.com/news/95/6249/wanted-a-bayh-dole-act-for-india.html https://biospectrumindia.com/news/95/6249/wanted-a-bayh-dole-act-for-india.html Thu, 07 Jul 2005 13:01:00 +0530 India's fledgling biotechnology industry has entered a critical phase by leaping over the $1-billion revenue mark. Though biotech has been around for over 25 years, the industry took shape in 2000 when dozens of academicians turned entrepreneurs. This is almost similar to the situation in the US 25 years ago, when a remarkable piece of legislation, called Bayh-Dole Act opened the floodgates of research centers and led to the emergence of the biotechnology industry as we know today. Based on the experience of the 25 years of this Act, most biotech experts believe that India too could benefit from such a legislation to give a further boost to the biotech sector. BioSpectrum Editor Narayanan Suresh reports about the importance of this legislation from Washington DC and Philadelphia. Major provisions of the Act include Non-profits, including universities, and small businesses may elect to retain title to innovations developed under federally-funded research programs Universities are encouraged to collaborate with commercial concerns to promote the utilization of inventions arising from federal funding Universities are expected to file patents on inventions they elect to own Universities are expected to give licensing preference to small businesses The government retains a non-exclusive license to practice the patent throughout the world The government retains march-in rights. It was December 1980. Ronald Reagan who had been elected as the President of the US in a landslide election was getting ready to begin the new era of prosperity for Americans. The US senate was having its last session of the year before adjourning for the Christmas season and a new look house would have taken charge in January 1981. Hours before closing, the Senate approved a small piece of amendment ( P.L.96-517) to the Patent and Trademark Act. Little did the sponsors of the amendments - Senator Birch Bayh of Indiana who had lost the elections in the Reagan landslide and Senator Bob Dole of Kansas - realize that they would not only attain immortality for this Act, but also seed the growth of the $91-billion biotechnology industry. The amendments are no longer referred their identification number. It is simply the Bayh-Dole Act. It created a created a uniform patent policy among the many federal agencies that fund research, enabling small businesses and non-profit organizations, including universities, to retain title to inventions made under federally-funded research programs. The Act is "perhaps the most inspired piece of legislation to be enacted in America over the past half-century," according to The Economist. "Innovation's Golden Goose," an opinion piece published in the December 12, 2002 edition of the respected publication, states: "Together with amendments in 1984 and augmentation in 1986, this unlocked all the inventions and discoveries that had been made in laboratories throughout the US with the help of taxpayers' money. More than anything, this single policy measure helped to reverse America's precipitous slide into industrial irrelevance." The Act is 25 years old. And the annual convention of the Biotechnology Industry Organization (BIO) hailed Bayh as a visionary and honored him at a special session on June 20, 2005 in Philadelphia. A new generation of scientist-turned entrepreneurs emerged all over the US, turning their academic research into successful products, backed by the power of the Bayh-Dole Act which specifically permitted such endeavors. The building of biotech The Bayh-Dole Act allowed universities and their faculty members to stake patent claims on discoveries they made through research funded by such federal agencies as the National Institutes of Health, instead of leaving ownership of the intellectual property with the government. That change accelerated the use of academic breakthroughs like gene splicing to develop biotech drugs and other products, giving rise to a three-way partnership of government, universities and startup firms that is "the envy of every nation," said Biogen Idec CEO James Mullen. Bayh-Dole Act: Success Stories According to a study by the Council on Government Relations (COGR), University patenting and licensing efforts under the Bayh-Dole Act have fostered the commercialization of many new technological advances that impact the lives of millions of people across the nation. A recent survey by the Association of University Technology Managers (AUTM) revealed that 70 percent of the active licenses of responding institutions are in the life sciences - yielding products and processes that diagnose disease, reduce pain and suffering, and save lives. Most of the inventions involved were the result of federal government funding. A few widely known success stories are: Artificial lung surfactant for use with newborn infants, University of California Cisplatin and carboplatin cancer therapeutics, Michigan State University Citracal(r) calcium supplement, University of Texas Southwestern Medical Center Haemophilus B conjugate vaccine, University of Rochester Metal Alkoxide Process for taxol production, Florida State University Neupogen(r) used in conjunction with chemotherapy, Memorial Sloan Kettering Cancer Institute Process for inserting DNA into eukaryotic cells and for producing proteinaceous materials, Columbia University Recombinant DNA technology, central to the biotechnology industry, Stanford University and University of California TRUSOPT(r) (dorzolamide) ophthalmic drop used for glaucoma, University of Florida These examples of successful new technologies demonstrate that a strong national infrastructure to support technology transfer has been established at academic institutions across the nation since passage of the Bayh-Dole Act. In 1980 there were approximately 25-30 universities actively engaged in the patenting and licensing of inventions. It is estimated that there has been close to a 10-fold increase in institutional involvement since then. National survey reflects the impact of this growth in activity: Academic institutions were granted more than 8,000 US patents between 1993 and 1997 for technologies discovered by their researchers. Over 2,200 new companies have been formed since 1980 that were based on the licensing of an invention from an academic institution, including over 330 companies formed in FY 1997 alone. Approximately $30 billion of economic activity each year, supporting 250,000 jobs can be attributed to the commercialization of new technologies from academic institutions. There are more than 1000 products currently on the market that are based on university licensed discoveries. Another proof of the success of the Act is the ever-increasing membership of the Association of University Technology Managers (AUTM) which increased from 200 in 1990 to 800 in 1999, and 691 in 1989 to 2,178 in 1999. In 1979, the year before passage of the Bayh-Dole Act, the Association counted only 113 members. In 1980, before the enactment of this Act, there were some 28,000 patents granted to various universities and research centers, developed using government funds. The titles were with the government Less than five percent of these patents were licensed to companies for developing them into successful products or applications. The government agencies were not keen to part with the licensing of these patents unless forced by legal action. And whenever it did, companies were given non-exclusive licensed. Very few companies took the risk of investing millions of dollars to turn them into products with the threat of competition having the access to the same technologies looming large. Bayh recalled that policy makers in the 1970 were worried by the declining competitiveness of the US in sectors like steel where the Russians had taken the lead. Discussions at various levels led to the amendments aimed to free the government-held patents for commercialization. "But I don't think any of us who worked so hard to get that passed had the slightest idea we'd be sitting here 25 years later in the birthplace of our country (Philadelphia where the US constitution was written), with all these people created by it," said Bayh looking at the thousands of biotech leaders who had assembled to listen to him. At the same time, he recalled, too little commercial use was being made of the thousands of government-owned patents flowing from the billions spent by federal agencies to fund academic research. "Nobody would spend thousands or millions to get it into your medicine cabinet," said Bayh. The solution, under the Bayh-Dole Act, was to allow universities and their scientists to own the patents and commercialize the inventions themselves. In what was at the time a revolution in academic culture, faculty members founded their own private firms or granted exclusive licenses to biotech company partners. Biotech CEOs credited the legislation for academic/industry partnerships that have yielded 60 biotech therapies,including Herceptin, a breast cancer drug from Genentech and Nupogen, a remedy for the dip in infection-fighting white blood cells that can result from chemotherapy. Amgen developed this drug. Of course, the Act is not without critics. The unprecedented co-mingling of the academic and commercial spheres has led to bias in scientific findings, undermined public trust in medical research and tilted universities toward profit-making projects rather than fundamental discoveries, said Sheldon Krimsky, a Tufts University professor and author of the 2003 book "Science in the Private Interest." Krimsky points to recent industry controversies over the alleged suppression of drug studies with unfavorable results, and disclosures that academics who serve on influential scientific advisory panels to government agencies like the FDA often have extensive ties to industry. Manufacturers who fund academic research have sometimes retained the right to veto publication of a university scientist's results, he said. During a panel discussion at BIO 2005, an expert panel grappled with the fallout from accusations last year that manufacturers of certain antidepressants had played down or withheld data showing increased risks of suicide linked to the drugs. It was pointed out that GlaxoSmithKline, settled fraud charges by promising to post all data online, and some others followed suit. Prestigious scientific journals are devising rules to guard against selective publication of favorable studies, to the exclusion of negative results. There were of course, the potential for a new world of bias or appearance of bias in the new world of academy-industry interactions. "Conflicts (of interest) are natural products of the system in which we work," said Roger Perlmutter, Amgen's executive VP. But such conflicts can be managed by the disclosure of industry connections, he observed. India too should have its version of the Bayh-Dole, commented many industry experts at a meeting of the Indo-US High Technology Group Meeting in Washington DC on June 15. The meeting was co-sponsored by the US Chamber of Commerce, Confederation of Indian Industry (CII) and FICCI. India too has a vast system of government-funded research laboratories and universities. The government has spent over Rs 20,000 crore ($45 billion) since Independence to support scientific research. In the 1990s, the Council of Scientific and Industrial Research (CSIR) introduced a system to reward scientists who develop with a portion of the royalties. Many other research centers follow different versions of this scheme. However, there is no legislative backup for such which can dramatically alter the way research is conducted and commercialized in India. ]]> <![CDATA[Global Challenges, Global Solutions]]> https://biospectrumindia.com/news/95/7595/global-challenges-global-solutions.html https://biospectrumindia.com/news/95/7595/global-challenges-global-solutions.html Thu, 07 Jul 2005 12:56:00 +0530 The biotech industry is becoming more competitive and is rapidly expanding beyond its borders. The industry is still dominated by the US sector and the relatively younger companies in Europe and Asia have some significant challenges ahead. They, however, have the benefit of learning from the US industry and have the ability to tap into resources and strengths from around the world, in what is rapidly becoming a truly global industry, says Beyond Borders, the Global Biotechnology Report 2005 of Ernst & Young "We see a bright future for biotech globally. There are already 290 approved biotech drugs and 55 more are awaiting regulatory approval. And the biotech industry's R&D spend is 50 percent more than that of the pharma sector," emphasized Ernst & Young (E&Y) partner, Utkarsh Palnitkar, while announcing the highlights of the report at a crowded auditorium at the BIO convention in Philadelphia on June 21. The globalizing nature of the industry is evident from the fact that nearly half of the publicly traded 641 biotech companies are now outside the US, the cradle of the industry. There were 59 initial public offerings (IPOs) by biotech companies worldwide in 2004, including India's first one by Biocon. Biotech entrepreneurs are finding new ways to raise capital. For example, there were 350 biotech companies in Germany. At least 35 of them disappeared last year, majority of them becoming insolvent. However, 30 new biotech companies were formed in 2004 and not one of them was helped by venture capitalists. "Biotech is the innovation engine of the economy. Small companies account for nearly two-thirds of the drugs in the pipeline," commented E&Y's Americas leader Mike Hildreth. Here is an extract from the introduction of Beyond Borders: "As the biotechnology sector matures and brings products to market, it is rapidly evolving, restructuring and recombining in response to unique challenges and opportunities. With biotech spreading across the globe, and strong progress in Asia, companies are no longer constrained to look for resources close to home. Increasingly, the answers to challenges are being found at the global level, as obstacles in one region are overcome by leveraging strengths and capabilities in another part of the world. Driven by the forces of competition, pricing pressure and funding challenges, the biotech sector is moving beyond borders on multiple fronts-locating activities around the world, and expanding aggressively into new industries and products. The pressure on drug prices is relentless and will only increase in years ahead. In Europe, some countries are already imposing a so-called "fourth hurdle" on top of the existing approval process, adding cost effectiveness to the criteria of safety, efficacy and quality. Following the lead of the UK, Germany established IQWiG in 2004, a new institute to advise the country's healthcare system about which treatments should be funded. In the US, Dr Mark McClellan, the new administrator of the Centers for Medicare and Medicaid Services has indicated support for such cost-benefit considerations. Pricing pressures will increase over time, as many industrialized nations grapple with budgetary constraints and aging populations. In this environment, companies need to find ways to increase the efficiency and productivity of drug development-put simply, they need to do more with less. Even as scientific progress brings exciting new cures to the clinic, the industry needs to control the cost of drug development, now estimated at $800 million per new drug. It's a daunting challenge, and while there are no easy answers, solutions are emerging. One potential solution lies in scientific advancements. With the advent of personalized medicine, companies may use increasingly focused clinical trials to drive down developmental costs and reduce the time to approval. A second solution is to harness biotech's growing global strengths. For several years, drug development companies have used alliances to focus on what they do best, while leveraging the strengths of partners for the rest. Examples abound, from the specialty pharma model that some biotechs have adopted, to the extended enterprise concept that many big pharmas pursue. Now, with China and India improving their regulatory systems, we are starting to see these trends go global in a big way. In recent years, both countries have boosted intellectual (IP) property protection, and with the passage of India's Patents Law in early 2005, the world's two largest markets allow for patenting of drugs. Western countries are already conducting research and development activities in the two countries, but many remain cautious about expanding research alliances to include more sharing of IP. Enforcement remains a big challenge, but if China and India demonstrate solid progress on this front, western companies should have no good reason to hold back, and many reasons to jump in-the cost savings could be tremendous. Less heralded, but equally significant, is the city-state of Singapore. With a long tradition of openness to trade and investments in technology, Singapore is on its way to achieving its Biopolis vision-the goal of becoming a world-class hub for biomedical manufacturing. Several of the world's biggest biotech and pharma companies have located facilities in Singapore, and others have announced plans to do so. While outsourcing has revolutionized industries in the West, from IT to financial services, the issue remains politically charged and was very visible in the 2004 US presidential elections. Any concerns about the outward migration of drug R &D should be outweighed by the huge benefit to western economies from lower drug development costs. In the drug pricing debate, analysts have long argued that the US subsidizes the cost of drug development for the rest of the world, since the absence of widespread price controls in the US market means that American consumers and taxpayers underwrite the lion's share of R&D. Now, as biotech and pharma develop extended enterprises on a global scale, the rest of the world could contribute in kind, by helping lower the cost of drug development. Countries around the world are competing fiercely to attract and develop biotech activity. To some extent, this is driven by improving Asian regulatory systems, which increases location options for the rapidly expanding sector. The industry's maturation and growth potential have also attracted the attention of national and regional governments across the world. From Malaysia to Michigan, governments are developing strategic plans with ambitious goals for growing biotech. One consequence of this aggressive competition is the "don't fence me in" factor. Companies are no longer constrained by the limitations of their local markets and can look for solutions in other parts of the world. This is most evident in the areas of stem cell and therapeutic cloning research. This increasing competition between regions could also help address one of the industry's most pressing issues-the dearth of early-stage capital. Though the global industry raised a whopping $21.2 billion in 2004, funding for early-stage development (the infamous funding "gap") remains a challenge for many, and a consistent theme across the globe. Across Asia, governments are setting up funds for their early-stage companies. In the US, several state governments are using tobacco settlement money for seed funds targeted at the industry. In addition, biotech companies are moving beyond geographic borders through alliances, mergers and acquisitions. The number of cross-border alliances grew from 421 in 2003 to 480 in 2004, a 14 percent increase. European companies in particular, went global in their search for partners, accounting for half of all cross-border alliances in 2004. Exporting Revolution As biotech companies search for ways to increase the efficiency and productivity, it may be reassuring to note the sector's long history of creating efficiency gains through scientific advances. It is no exaggeration that biotechnology produced a revolution in drug development, as a series of breakthrough technologies took the 160-year-old pharmaceutical industry and reinvented it. High throughput screening revolutionized the process of target identification. The development of DNA sequencing machines by PE Biosystems (now Applied Biosystems) shaved years off the mapping of the human genome, and changed forever the fields of genomics and proteomics. The invention of monoclonal antibodies transformed the diagnostic industry, and after some hiccups along the way, is bringing to market revolutionary new treatments for diseases such as cancer. The field of pharmacogenomics, just starting to bear fruit, will change medicine as we know it by transforming the one-size-fits-all drugs of yesterday into the targeted therapies of tomorrow. Extraordinary achievements such as these overshadow that most of what we have seen so far is the application of biotechnology to just one existing industry. The word biotechnology is often used to describe what is, in fact, the health biotechnology sector. But the term literally refers to a set of biologically-based techniques that could be applied to a wide range of industries. With the introduction of the first genetically modified (GM) crops in mid-1990s, the global area of biotech crops has increased by double-digit growth rates, growing 20 percent in 2004 alone. Biotech crops are now being cultivated in 18 countries, with R&D conducted in another 45 countries. Similarly industrial biotechnology has the potential to shake up another long-standing sector-chemicals and industrial manufacturing. Industrial biotech is being driven by new varieties of enzymes, which are protein catalysts that step up chemical reactions in cells. Biotechnology is making numbers work, by creating GM enzymes so that existing production processes do not have to be altered. Second Wave The first wave of biotech products was recombinant proteins, based on recombinant DNA technologies. More recently, the second major wave of biotech products, therapies based on monoclonal antibodies (MABs), is reaching critical mass. Several of the product approvals in 2004, including Humira, Remicade, and Campath are MABs. Personalized medicine is emerging as well, with tremendous potential to improve health care. Drugs such as Gleevec and Herceptin have already been developed on the premise of targeting specific genotypes. The widely anticipated approval of NitroMed's BilDil could bring the first drug targeted to a specific demographic group." ]]> <![CDATA[India's Scientific Community Must Become More Assertive]]> https://biospectrumindia.com/news/95/8483/indias-scientific-community-must-become-more-assertive.html https://biospectrumindia.com/news/95/8483/indias-scientific-community-must-become-more-assertive.html Thu, 07 Jul 2005 12:25:00 +0530 The Indian scientific community should communicate the risks and benefits of modern biotechnology to the public in a sustained manner. Lately stem cell research is making head lines in the world of science. Stem cell research is being touted as the next wave of medical biotechnology that could potentially revolutionize treatment of diseases in the next couple of decades. Stem cell research has become very controversial in the US, and this controversy will follow wherever it goes. Certainly, there are ethical concerns that are mostly based on ones religious proclivities and they are being pandered by the political class as always. This is becoming more and more egregious in the US with the divided National Bioethics Commission advising the President to take regressive positions on embryonic stem cells to appease the religious right. President Bush has banned embryonic stem cell research in any federal institution or in any federally funded research program save for some already existing cell lines. There is a great deal of scientific uncertainty as to what shape or form the stem cell research agenda is going to take in the US. The State of California has gone ahead with its own promotion of stem cell research by selecting San Francisco as the global hub of stem cell research and hopes to attract billions of dollars of investment in the area. California is investing $3 billion upfront to attract leading researchers and investments on stem cell research to come to San Francisco. Ultimatum to White House Fed up with the lack of federal leadership, the US National Science Academy offered its own guidelines for stem cell research in May which the scientific community supports wholeheartedly and has sent a clear message to the White House that if it does not act, they will go ahead with stem cell research on their own voluntary guidelines. The American scientific community, it seems, is determined not to be left behind on stem cell research because of lack of federal leadership on the issue. That is the kind of bold leadership from a country's scientific body that is required to drive scientific agenda in any country that is seriously committed to harnessing science and technology for progress and economic development. The US National Science Academy's bold move comes in the wake of a serious effort under way in Southeast Asia on stem cell research. China and Korea have made significant commitments to stem cell research and are poised to become the leaders in the field. India also jumped into the fray a few years back, and as always, without much thought and preparedness. India's biotech private sector lead by the Reliance group, has committed considerable resources to stem cell research. All of a sudden one hears that AIIMS scientists have started stem cell therapy experiments and never bothered to ask anybody's permission a la Bt-cotton in Gujarat seven years ago. In addition, scores of private nursing homes and hospitals (that are largely unregulated) are engaged in experimental stem cell therapy without any oversight. These same establishments have misused and abused sex determination techniques and also In-Vitro fertility technology with impunity. Sale of kidneys became a national scandal few years ago. There is not a decent public law to govern organ donations and there is not even a central registry from where one can find out anything about organ donations. The private sector which has the most to gain from the stem cell technology must demonstrate leadership in corporate social responsibility and develop volunteer guidelines to see that the benefits of stem cell research is harnessed in an ethically appropriate and socially responsible manner. Ignorance is not bliss India is ambitious of harnessing stem cell research and is perfectly capable becoming a world leader, but it has to do some quick home work before jumping headlong into the field. ICMR and DBT seem to have made some noise about developing a policy, but have nothing much to show for it, and certainly there has not been much of a stakeholder debate on the issue. India has a national bioethics commission whose existence it seems is some sort of a national secret. The Indian Medical Council and the Indian Medical Association are feigning ignorance of the subject as if it is of no concern to them. No one in the public or the scientific community knows what the three major academies of science in India think on the issue. The ministry of health recently said that it did not even know that AIIMS was doing stem cell therapy experiments. But, one can already hear noises from the civil society organizations and non-governmental organizations that lose no time or momentum to start howling. When they take charge, there is no telling what kind of regulations will be put in place. But, once can be most certain that science will not be the underpinning of those regulations. Recently the National Center for Biological Sciences (NCBS) hosted an international meeting in Bangalore on stem cell research in collaboration with scientists from the UK, and professed to be guided by a voluntary code of conduct. It is unclear what these voluntary codes are, but nevertheless, it is a good beginning. They must keep up the momentum and lead the charge publicly. The kind of a mess that one sees in the regulation of GM crops must not be allowed to repeat in the medical field. Stem cell research will need significant private investment and therefore scientists from the academia and the industry must make this a common cause to take charge of the research agenda. Apathy from the scientific community will not be acceptable any longer, and they owe it to themselves to the country to show political leadership and communicate with the public directly before the anti-biotech brigade can inflict undoable public relations damage on it. India needs to be more vocal The last time the Indian National Science Academy had anything to say on the issue of regulating GM crops was at a press conference a decade ago in far away London in the company of four other national academies of science. The Indian public did not hear about it and the Indian anti-GM brigade does not care about it. The Indian political establishment is completely oblivious and is willing to be led by anyone who cares to talk to them. Everyone knows that the Indian scientific community is not the one doing the talking. One cannot fathom the reason for aloofness of the scientific community from this important technology issue. It is not enough to "preach to the choir" by making customary speeches and publish books and papers just for the benefit of their ilk. These academies have to get into the activists mode and barrage the media and the public just like the Luddites do. If the scientists shy away from this responsibility, then they have only themselves to complain about. To say that the public does not understand science is a tired old argument that cannot and should not be used any longer. This apathy of the scientific community allows all sorts of ignoramuses in the name of protecting the public from the dangers of the technology to spread falsehoods, innuendos and outright lies to confuse media and the public. It is time for the Indian scientific establishment to become a little bit of activists themselves and provide leadership in communicating the risks and benefits of modern biotechnology to the public in a sustained manner. It is time for India to grow and cultivate charismatic science communicators to do the job because the 21st century public policy on science in India will be made by the public in public. Everyone these days demand pluralism in technology decision making. The scientific community in India must assert its role in science policy making, communicate with the public, and demonstrate its true leadership. Shanthu Shantharam Biologistics International, Ellicott City, MD, USA sshantharam@biologistics.us ]]> <![CDATA[Pharma R&D opportunities in India]]> https://biospectrumindia.com/news/95/2949/pharma-rd-opportunities-in-india.html https://biospectrumindia.com/news/95/2949/pharma-rd-opportunities-in-india.html Thu, 07 Jul 2005 12:22:00 +0530 India offers a unique opportunity to established pharma and biotech companies to discover and develop new molecules Pharma R&D in developed countries is experiencing serious problems in terms of huge bottlenecks, lengthening timelines, and flat productivity in spite of exponential increase in budget over the last one decade. The emerging positive trends in India offer a potential solution to some of the these problems. There are seven key broad areas to leverage the advantages that India offers to the established pharma and biotech industries. These include contract research, R&D alliances, clinical trials, R&D for neglected diseases, in-licensing of preclinical as well as early clinical drug candidates, IT applications and data management and herbal heritage. India has already established its strength in developing, manufacturing and marketing generic products for global market. This success is attributed primarily to its strength in the process chemistry, formulation development and manufacturing areas. Transition to innovative R&D is the natural next step for India. To that end, there are a number of contract research organizations that offer quality and cost-effective services in medicinal chemistry, formulation development, and toxicology areas. In order to do justice to idle intellectual properties and to address the issue of bottlenecks, pharma companies from developed countries are already forging R&D alliances with Indian companies. Such alliances are expected to yield preclinical candidates or clinical candidates with proof of concept in humans. Failure is the norm in pharma R&D business. One of the key contributing factors for the huge projected cost ($800 million) for bringing a new molecule to market include the cost of failures. Within the pharma R& D value chain, failures occur at various stages and cumulative success rate of a given drug discovery program is about 1.5 percent. The probability of success increases to about 50-75 percent once a molecule enters Phase III clinical trials. By conducting R&D on new molecules up to Phase II clinical trails in a country where the cost of innovation and development can be one fourth, it is conceivable to reduce the cost of failure and eventually overall cost of bring new medicines to patients. This is one of the unique opportunities that India offers at this time. There are not enough patients and qualified clinical investigators in North America and Western Europe to support clinical evaluation of all drug candidates in development. Such shortage obviously results in costly delays in obtaining proof of concept in humans as well as completing required regulatory clinical trials. Low cost of innovation and development will allow bringing new molecules for the neglected diseases to market at a much reduced cost. Since the medicines for neglected diseases must be affordable to patients in the poor countries, it is essential to develop these drugs in the most cost-effective manner. India is an obvious option to address the need for the neglected diseases. Indian pharma R&D has already proven its capabilities in discovering and developing druggable molecules. A number of development candidates are out-licensed by Indian companies to the medium size as well as large pharma companies in the developed countries. This trend is expected to continue. India is recognized as one of the leaders in the IT industry. This strength in India is already being leveraged in the bioinformatics area to support a variety of drug discovery efforts. In addition, a number large pharma companies are leveraging India's IT strength to support clinical trials and data management. This can be easily extended for safety monitoring and post-marketing surveillance. Traditional medicines are well-established in India. However, the molecular mechanism of action and identity of active ingredient(s) may not be known for most of these traditional medicines. There are opportunities to apply modern science to elucidate molecular mechanism of action and to identify active ingredients of these medicines. The process of reverse pharmacology can be applied to discover druggable new molecules from these traditional medicines. In summary, India offers a unique opportunity to established pharma and biotech companies to discover and develop new molecules â€“ offering key advantages in the areas of quality, speed and cost-effectiveness. Rashmi H Barbhaiya CEO and Managing Director, Advinus Therapeutics, Bangalore, and New Jersey USA ]]> <![CDATA[BioClusters]]> https://biospectrumindia.com/news/95/1715/bioclusters.html https://biospectrumindia.com/news/95/1715/bioclusters.html Thu, 07 Jul 2005 12:18:00 +0530 CANADA Punjab signs MoU with Province of Saskatchewan The state of Punjab and the Province of Saskatchewan signed two Memoranda of Understanding (MoU) to work collaboratively to develop scientific, economic and technical linkages and initiatives for the benefit of both Saskatchewan's life science sector and the Punjab. These collaborations could include transfer of technologies for improvement of pulse and cereal crops, support for the establishment of collaborative research projects aimed at crop improvement, support for advances in crop processing and utilization, as well as the establishment of company to company business relationships in agricultural science. The MoU was signed during the state chief minister Capt Amarinder Singh's visit to Province of Saskatchewan. During the visit the team led by him met with the Saskatchewan Minister of Industry and Resources, Eric Cline, Saskatoon's Mayor Don Atkinson, and leaders from the Saskatchewan life science community. On behalf of the Province of Saskatchewan, Minister Cline signed a five-year MoU alongside Avtar Henry, the Food and Supplies Minister. This relationship was initiated in October of 2004 when Dr Ashley O'Sullivan, president and CEO of Ag-West Bio, was part of a mission to Punjab. During this mission, Ag-West Bio and the Punjab Biotechnology Park Ltd. (PBPL) of Chandigarh signed a MoU to develop a framework of collaboration for economic, scientific, and technological developments in agricultural and environmental biotechnology, bioprocessing, and health care. As a result, several potential deals are currently being facilitated between Indian and Saskatchewan companies. Source: www.biotech.ca ASIA Pakistan set to enter GM cotton era "The developments made in cotton biotechnology by the country's scientists were quite impressive and that Pakistan was set to enter the era of genetically-modified cotton once the bio-safety guidelines, to be issued by the Ministry of Environment, were put in place," said Sikandar Hayat Bosan, Federal Minister for Food, Agriculture and Livestock. Speaking at an international conference on " Biotechnology for Salinity and Drought Tolerance in Plant" at Islamabad, Bosan said, "Six million hectares in Pakistan were affected by salinity and water logging, owing to which 25 per cent productivity of crops had been affected. Biotechnology was the only solution to the problem." Bosan further noted that Prime Minister Shaukat Aziz had instructed the Ministry of Environment to finalize the bio-safety guidelines. Source: www.agbioworld.org   NEW ZEALAND New Zealand to invest $41 million in business R&D New Zealand's Biotech Industry Organisation (NZBio) has congratulated the government on a solid incremental improvement in funding for research, science and technology in this years' budget. "The government has made a significant investment of $41 million in Technology New Zealand, an initiative that supports business R&D," Brian Ward, CEO, NZBio said. "We also welcome the extra $16.2 million for industry-based research through research consortia, the additional $14.7 million to expand Technology for Industry Fellowships Programmes, and $58.4 million for regional and sectoral development. "Supporting the biotechnology business community will ultimately strengthen New Zealand's economic basis, and the increase in research funding will be very beneficial for companies wishing to commercialize technologies, improve their ability to innovate and compete internationally. "Other good news for the biotechnology sector includes changes in taxation law that will see the removal of barriers to R&D investment, and temporary tax exemption on the foreign income of new migrants and New Zealanders who have been non-resident for tax purposes for at least 10 years and come back here to work. New Zealand's biotechnology industry needs the best international talent available, and these measures will go a long way towards encouraging ex-pat Kiwis and new migrants to build their careers here," Brian Ward said. Source: www.nzbio.org.nz AMERICA New Bioenergy Bill introduced The Biotechnology Industry Organization (BIO) strongly endorses the National Security and Bioenergy Investment Act of 2005, introduced by Tom Harkin and Richard Lugar, members of the Senate Agriculture, Nutrition and Forestry Committee. The bill updates the Biomass Research and Development Act with the goal of rapidly boosting the production of bio-based fuels at competitive prices, developing a broad range of bio-based products that replace petroleum-based products, and expanding opportunities in the growing bio-economy. The Bill also establishes incentives to increase the production of ethanol from cellulose-containing crops and crop wastes and expands the Federal Agency Biobased Procurement Program among other things. Source: www.bio.org ]]> <![CDATA[Swiss biotech industry set to grow]]> https://biospectrumindia.com/news/95/1467/swiss-biotech-industry-set-to-grow.html https://biospectrumindia.com/news/95/1467/swiss-biotech-industry-set-to-grow.html Thu, 07 Jul 2005 12:15:00 +0530 The Swiss biotech industry is among the largest and most diversified in Europe. Accounting for 79 of the 465 European products in the pipeline, the Swiss biotech industry ranks an impressive second in Europe in terms of revenue and market capitalization according to the Swiss Biotech Association. In terms of the number of core biotech companies, Switzerland ranks sixth in Europe and ninth worldwide. Compared with the size of its population, Switzerland has the highest biotech density worldwide. "One Nation, One Biotech Cluster," said Domenico Alexakis, executive director, Swiss Biotech Association (SBA). How does the SBA promote Switzerland as an attractive location for biotechs? The SBA is proud to be founding member of the four organized geographic biotech clusters from Bio Alps (Bassin Lemanique), Bio Polo Ticino (Southern Region), Bio Valley Basle and Greater Zurich Area. The alliance is completed by the SWX Swiss Exchange. In conjunction with these partners, it is a lot easier to promote the sector on a national and international level. In fact, we are the only country worldwide which can position "one nation - one biotech cluster." The regional geographical and business specialties make the appearance interesting and varied in form. The SWX Swiss Exchange has put emphasis on the sector early on and is known as one of the best listing places for life science companies. How does the SBA support the companies? The companies communicate their needs to our board of directors or directly to the executive office. We then discuss the matter and execute a process, which in the end goes back to the individual member company or results in a short member information/consultation, etc. The tasks vary from writing a recommendation letter to organizing an SBA event on a particular topic. The variety of the industry is mirrored in the variety of the company needs. About one-third of all Swiss core biotech companies have been founded before 1995 and by the end of 2003, the industry employed over 13,000 people. Switzerland has approximately 250 small and medium-sized enterprises active in biotechnology. Biotechnology enjoys a favorable regulatory and administrative environment in Switzerland. The entry into force on January 1, 2004 of the Federal Act on Genetic Engineering in the Non-Human Domain, will soon be complemented by similar legislation for the human domain according to SOFI. These regulations not only cover current technology, but strengthen the legal basis for further developments in biotechnology. On the administrative side, the federal co-ordination centre for biotechnology provides one-stop processing of notifications and applications for authorization. Swiss delegation visits India With a view to promote Indo-Swiss business in the biotech sector, the Swiss Organization for Facilitating Investments (SOFI) led a delegation of seven companies from Switzerland to India recently. The Confederation of Indian Industry (CII), its MOU partner Swiss Organization for Facilitating Investments (SOFI) and Embassy of Switzerland had coordinated the visit of an 11 member Swiss Biotechnology Entrepreneurs Mission to India in the first week of May. This was a follow up visit to the CII's mission to Zurich in October last year. According to Viktor Grabik, mission coordinator and director, Subâ€“Saharan Africa and Indian Sub Continent, SOFI, the visit of Swiss delegation to India was very fruitful, as it has thrown up a gamut of opportunities for forging alliances and joint ventures. Addressing the participants, Domenico P Alexakis, leader of the mission and executive director of the Swiss Biotech Association, said that it was the first step towards a meaningful dialogue in identifying business opportunities and areas of synergy between India and Switzerland in the emerging sector of biotechnology and specifically mentioned that the delegation was highly impressed by state of the art technology used by some of the Indian biotech companies. During the visit, the delegation traveled to Bangalore, Mumbai, and New Delhi to interact with Indian biotech companies and research institutions to look at practical ways of promoting investment and business between the two countries. The delegation also made a courtesy call to Kapil Sibal, Union Minister for Science and Technology. CII also signed an MOU with SOFI to promote much greater industrial and commercial cooperation between the two countries. A business meeting of Indian entrepreneurs under the Association of Biotechnology Led Enterprises (ABLE) was also organized in Bangalore. ]]> <![CDATA[Partnerships, a New Growth Model for Biopharma Firms]]> https://biospectrumindia.com/news/95/2534/partnerships-a-new-growth-model-for-biopharma-firms.html https://biospectrumindia.com/news/95/2534/partnerships-a-new-growth-model-for-biopharma-firms.html Thu, 07 Jul 2005 10:51:00 +0530 Indian biopharmaceutical companies are dreaming big. To achieve this, they have taken the route. They are forging partnerships either in R&D, marketing or in manufacturing. Biocon Ltd, India's leading biotechnology company is in the forefront in entering into partnerships with other companies. Others in the game are Serum Institute of India, Nicholas Piramal India, Panacea Biotec, Avestha Gengraine Technologies, Indian Immunologicals, Wockhardt, Bharat Biotech International and Biological E. About 20 partnerships/joint ventures have been signed between biotechnology and pharmaceutical companies in the last 18 months. Most the leading Indian biopharmaceutical companies have adopted the partnership strategy as a growth model. Indian companies have started looking at this business model for different activities such as R&D, manufacturing, contract research and marketing. Biocon has entered into alliances in R&D, marketing and manufacturing spaces with different companies. It has entered into an alliance with US-based Bristol-Myers Squibb Company to supply recombinant human insulin in bulk form for nine years. Biocon has also entered into a research tie-up with North Carolina's Nobex Corporation to jointly develop oral insulin for the global and Indian market, as well as a strategic partnership with New York-based Vaccinex to discover and co-develop at least four therapeutic antibody products. As part of the deals, Biocon will also make equity investments in Vaccinex and Nobex. Biocon's subsidiary Syngene International has also entered into a contract research agreement with the R&D arm of Novartis, the Novartis Institutes for Biomedical Research Inc. Syngene will conduct research to support new drug discovery and development, primarily in the early stages, involving small molecules in oncology and cardiovascular segments. Serum Institute of India Ltd, a leading manufacturer of vaccines in India, is another company which is into partnership with an MNC. Serum Institute has signed an licensing agreement with London-based Lipoxen Technologies Ltd in a major product development program. The agreement involves eight new product candidates in total, including protein drugs such as GCSF and EPO, anti-cancer drugs and vaccines. The Serum Institute provides the active ingredients and Lipoxen provide the enhanced delivery systems. The agreement combines Lipoxen's strengths in intellectual property and innovation in the drug delivery field. Under the agreement Serum will retain control of marketing in India, Africa, Asia (except Japan) and Latin America, taking advantage of their existing distribution infrastructure. Lipoxen retains control of marketing and sub-licensing in the major market territories and seeks collaboration partners for the marketing of these products in such territories. Avestha Gengraine Technologies, a Bangalore-based integrated biotechnology and bioinformatics company focusing on the convergence between food, pharma and clinical genomics leading to preventive personalized medicine, has entered into alliances with companies for R&D and marketing activities. The growth models of pharma and biotech companies The tepid valuations of many companies on public markets by venture capitalists may push companies to look at alliances, mergers and acquisitions as growth models. With increase in the cost of launching newer drugs and profit margins being diverted towards R&D activities, alliance, mergers and acquisition (M&A) have become the norm of pharma and biotechnology industries. The global trend is big pharma companies are eyeing biotech companies which are into R&D and developing newer molecules to enhance their product portfolio. The significant M&As that happened in 2004 in global biotech space include acquisition of Tularik by Amgen, the world's largest biotechnology company, for $1.3 billion. Genzyme acquired Physician services business of IMPATH for $215 million and ILEX Oncology for $1 billion. The companies are not limited by geographic boundaries in their search for strategic partners for growth. A Canadian biotech firm QLT acquired Atrix Labs for $855 million in stock. Similarly Icelandic generics major Actavis has acquired Bangalore-based contract research organization, Lotus Labs in a Euro 20-million all-cash deal. This trend for CRO acquisitions is increasing and many pharma companies are said to be considering India for such strategic investments. The Ahmedabad-based Dishman Pharmaceuticals and Chemicals has acquired an UK-based contract research company called Synprotec with an asset base of around £2 million, through its subsidiary, Dishman Europe. Torrent Pharmaceuticals, again an Ahmedabad-based, is close to acquiring a German company engaged in generic drugs business through its German subsidiary. In the recent past, many Indian pharma companies have acquired European ones. The recent ones include Wockhardt's acquisition of UK-based generic drugs manufacturer CP Pharmaceuticals for Rs 83 crore in an all-cash deal; Zydus Cadila's acquisition of the formulation business of Alpharma of France for a consideration of Euro 5.5m, and more recently, Ranbaxy acquired the French generic drug company RPG Aventis for around $70 million. Amalgamations On the contrary, a few others adopted mergers as a growth model for their business. In this we find amalgamation of Glenmark Laboratories and Tasc Pharmaceuticals. The merged new entity would be present both in the bulk drug and the finished dosage form segments. Even the boards of Matrix Laboratories and Strides Arcolab, have, in principle agreed to a merger plan that will take the merged entity into the premier league of Rs 1,000 crore-plus pharmaceutical companies. On completion, the merged entity - Matrix Strides - would have operations in over 70 countries with manufacturing operations in India, the US and Latin America. Meanwhile Matrix Labs has decided to acquire a Belgium-based $263-million pharma company Docpharma NV. However, some others continue to look at alliance or partnership model. Novavax Inc, a specialty biopharmaceutical company has entered into an agreement with Ranbaxy Labs to evaluate a new transdermal product. Upon successful completion of the proof of concept study, the companies expect to enter into a broad commercialization and development agreement. Abbott India has entered into a fresh distribution agreement with Novo Nordisk India for the sale and distribution of their insulin products in India for the period two years as the earlier distribution agreement with Novo Nordisk had expired by December 31, 2004. Considering the huge market potential, MNCs are looking at India to expand their business. Belgium-based Janssen Pharmaceutica, which has a presence in India through Janssen-Cilag Pharmaceuticals, a part of Johnson & Johnson (J&J) Ltd, is looking at forging alliances /partnerships in the area of research and development, discovery, clinical research and chemical manufacturing. The prospects for continued growth will depend much on how successfully these companies adopt these business models, as drivers behind this trend remain unchanged. Avesthagen has entered into a strategic tie-up with two investors towards furthering its R&D efforts. The company has received a sizeable amount of investments from two strategic investors including Godrej Industries Ltd. The strategic partnership is part of its plans of attracting investments through partnership and the way forward for Avesthagen. It has also entered into research collaboration with Sequenom Inc., to analyze Sequenom's proprietary panels of genetic markers associated with diabetes as well as with breast and lung cancers in Indian patient samples. The results of this collaboration could provide further validation of Sequenom's genetic markers and improve the understanding of the role of these genetic markers in disease onset, progression and therapeutic response. Avesthagen has announced a strategic joint venture with the Denmark-based Centre for Clinical & Basic Research (CCBR) and its subsidiary Nordic Biosciences. Both will work together on a wide array of aspects covering the diagnosis, treatment and prevention of osteoporosis and osteoarthritis. And also work together to develop the market in India and worldwide for a biomarker-based diagnostic kit that significantly improves on existing technology. It has also entered into research alliance with Cipla to develop biopharmaceuticals. Under the terms of the agreement, Avesthagen will focus on research and product development, while Cipla will focus on marketing and distribution. In order to strengthen its vaccine portfolio, Hyderabad-based Biological E has entered into a strategic alliance with the US-based pharmaceutical major Intercell AG for the development, manufacture and sale of the latter's Japanese Encephalitis vaccine in Asia. According to the agreement, Biological E will manufacture the product in India for the Asian endemic market, while Intercell AG would concentrate to market the product in the US, Europe and Australia. Besides biotech-pharma deals we also see a biotech â€“biotech deal. One of the major deals is Chiron Vaccines joint venture in India with Panacea Biotec. This 50:50 joint venture Vaccines Pvt Ltd will focus on marketing of Hepatitis B and cocktail vaccines in the private markets in India. Panacea Biotec will look after the institutional sale to UNICEF/WHO. It has also entered into a collaboration with the UK-based Cambridge Biostability, for manufacturing vaccines in India using the "stable liquid technology", which reformulates existing vaccines into ready-to-inject stable liquids thereby revolutionizing the vaccine delivery system by eliminating the need of refrigeration for vaccine storage. Bharat Biotech International Ltd has signed a joint venture agreement with South Africa's gold and diamond company Mvelaphanda Holdings in 2004 to set up a manufacturing plant for vaccines and generic drugs near Johannesburg. Under the agreement both Bharat Biotech and Mvelaphanda would have equal stake. The South African plant would be set up at an investment of Rs 125-150 crore. Human Biologicals Institute (HBI), a division of the Indian Immunologicals Ltd, has entered into an alliance with Vins Bioproducts Ltd. This is mainly for marketing its product called Equine Rabies Immunoglobulin (ERIG), a drug for animal bite management, under the brand name "AbhayRIG" through HBI's 2,000-odd "Abhay" clinics spread across the country. Even Nicholas Piramal India Limited (NPIL), one of the leading pharmaceutical companies in India focusing on biotechnology, has entered into agreements with a couple of US-based companies for marketing their biotech products in India. It has signed an agreement with Gilead Sciences for the Indian marketing of its biotech drug Ambisome - a treatment for deep-seated fungal infections. NPIL has also entered into an in-licensing pact with Genzyme Corporation for marketing Synvisc, a viscose supplement. NPIL has already entered into a strategic alliance with Biogen Idec, the third largest biotech company in the world. NPIL's Biotek division is marketing Avonex (Interferon beta 1a), a leading life-saving therapy for Multiple Sclerosis (MS), in India and Nepal. Considering the growth of biotechnology products in the third world countries Wockhardt with three indigenously developed biotechnology products has formed majority joint venture in Mexico and South Africa. Wockhardt has signed a joint venture agreement with Representaciones E Investigaciones Medicas, SA de CV, one of Mexico's leading national companies. Wockhardt Mexico SA de CV, 51 percent owned by Wockhardt, will initially market all forms of insulins manufactured by Wockhardt. At a later stage, it will market other diabetology products and biopharmaceutical products. Wockhardt South Africa Pty Ltd, a 51:49 joint venture between Wockhardt and Pharma Dynamics, will use the regulatory, sales and marketing expertise of Pharma Dynamics to commercialize the growing pharmaceutical and biopharmaceutical portfolio of Wockhardt. These are some of the partnerships that the top Indian biopharmaceutical companies have entered into to take the lead in the growing biotechnology industry that has registered a growth of 36.55 percent in 2004-05. Growth a driver for alliances The high growth of the biotech industry over the pharma growth is pushing for more alliances and tie-ups between pharmaceutical and biotechnology companies in India. Many entrants into biotechnology via tie-ups for marketing in India continue to focus on alliances. Companies like Glenmark Laboratories, Claris Life sciences and Emcure Pharmaceuticals are looking for alliances and seeking permission from the Genetic Engineering Approval Committee (GEAC) for import and marketing of biotech products in India. Glenmark Laboratories, which is into marketing of recombinant biotech products is eyeing the import of r-hu-Epidermal Growth factor for manufacturing in India a fixed dose combination of 10 ug/GM and Silver Suphdiazin 1% as a Cream for Topical in burn cases from GGE and Biotechnology, Cuba. Similarly Ahmedabad-based Claris Life Sciences is seeking GEAC's permission for import and marketing of r-Human G-CSF, 300mcg in prefilled syringes in finished form from North China Pharmaceuticals (NCPC) Genetech Biotechnology Co, Ltd. China. Pune-based Emcure Pharmaceutical which entered the biotechnology sector with the import and marketing of Erythropoietin developed by a Chinese company Dragon Pharmaceuticals, is now seeking permission for import and marketing of r-human Granulocyte Macrophage Colony stimulating factor in (GM â€“ CSF) from Shenghai Hygene Biopharma Company Ltd. China. Unlike the global scenario in biosuppliers where we find more of acquisitions by the leading players consolidating their positions, in biotechnology industry the trend is towards alliance and partnerships. This is because most of the biotech companies are privately owned and spend their resources on highly focused and innovative biotechnology-based research. These cash constraint firms look for financial support mainly from VCs. Though biotech is one of the fields VCs are eyeing, they not eager to invest at this point of time in the biotechnology industry. The only alternative left for these upcoming biotechnology companies is joining hands with big pharma/ biotech companies. As rightly pointed out by Ernst & Young in its "Beyond Borders 2005", for biotechnology companies, partnership is an important means of mitigating risk as well as a strategic response to business challenges. Since drug development is an inherently high-risk business, characterized by large R&D investments and relatively small probabilities of success, partnerships will always be an important factor in diversifying and mitigating risk. It is also one of the ways of entering newer potential markets. Big pharma companies and some of the leading biotech companies are looking for ways to expand their product pipelines and identify promising targets and products. For many smaller biotech companies, raising capital is an overriding concern. This motivates them to enter into alliances to generate revenues or to accelerate their path to products, as investors in both the public and private markets demonstrate a strong preference for companies with products or late-stage pipelines. On the other hand, leading companies are entering into joint ventures with local firms to market their range of products. Based on the present scenario, the year 2005 will see more partnerships provided the companies get support from the government by enforcement of the product patent. Some of the partnerships signed in the last 18 months Companies Collaboration Biocon Bristol-Myers Squibb Supply Biocon Nobex Corporation R&D Biocon Vaccinex R&D Syngene International Novartis Institutes for Biomedical Research Inc Contract research Serum Institute of India Lipoxen Technologies Product development Human Biologicals Institute Vins Bioproducts Marketing Biological E Intercell AG R&D, manufacture and marketing Panacea Biotec Chiron Vaccines Marketing Panacea Biotec Cambridge Biostability Manufacturing Nicholas Piramal Gilead Sciences Marketing Nicholas Piramal Genzyme Corporation Marketing Avestha Gengraine Technologies Godrej Industries Attracting investments Avesthagen Sequenom Inc R&D Avesthagen CCBR and its subsidiary Nordic Biosciences R&D Avesthagen Cipla R&D Bharat Biotech International Mvelaphanda Holdings Setting up manufacturing facility Wockhardt Representaciones E Investigaciones Medicas Marketing Wockhardt Pharma Dynamics Marketing   Narayan Kulkarni ]]> <![CDATA[The First Billion $]]> https://biospectrumindia.com/news/95/2637/the-first-billion-.html https://biospectrumindia.com/news/95/2637/the-first-billion-.html Wed, 15 Jun 2005 14:48:00 +0530 These are exciting times for the Indian industry. The biotechnology industry is still in the toddler stage but in its own way is contributing to the excitement all around. What better way to do it than adding over a billion dollar, $1.07 billion to be precise, in revenues in the 12 months ending March 2005. N Suresh It is an important threshold that has been crossed. The 2nd edition of the BioSpectrum-ABLE survey in August 2004 had forecast that the $1-billion mark might be breached in 2004-05. And the 3rd edition of the industry survey has indeed captured the burgeoning numbers of the Indian biotech sector. The growth rate of the industry has dipped by nearly three percent over the previous year's 40 percent mark. But that was expected considering the increasing revenue base of the sector as a whole. Still, a 36.55 percent growth, helped a lot by the phenomenal revenues booked by the sale of transgenic cotton seeds of two companies - Mahyco-Monsanto and Rasi Seeds - gives the sector a lot to cheer. There are other major contributors like Biocon, Panacea, Shantha Biotechnics, Serum Institute and Venkateshwara Hatcheries, who have maintained high growth rates to propel the biotech industry forward. Biotech industry has close linkages with the pharma sector. And the Indian pharma industry which is more than 30 years old, is only seven times bigger, will put the biotech industry's figures in perspective. Globally too it was a good year and two biotech companies, Amgen ($10.6 billion) and Genentech ($4.6 billion) have entered the ranks of the Top 20 therapeutic companies for the first time. The First Billion Dollar is an important milestone achieved collectively by the biotech sector. It is just 1.1 percent of the global biotech industry in 2004 ($91 billion, estimated by the BioSpectrum Life Sciences Advisory Services). The US continues to dominate the sector accounting for 78 percent of the industry. But other countries are making a determined effort. The efforts of the biotech industries in Europe, Australia and South Korea to match the US prowess in the decades, is captured in a special section. The Indian government has recognized the potential of the biotech sector and is doing everything to help the sector. Our policy makers can learn from Korea's determination to become one of the "biotech superpowers" by 2012 from its current share of 2.2 percent. The Korean government is removing every barrier in the industry's path and providing every support it needs to achieve this lofty goal. BioSpectrum and ABLE embarked on this exercise three years ago to standardize the way the industry size is measured and set the parameters for the growing industry to measure itself and also benchmark against the counterparts in an increasingly globalizing sector. It is heartening to note that the BioSpectrum-ABLE Industry Survey is now the most awaited and accepted benchmark in Indian biotechnology industry. Improvements in the survey is an ongoing exercise. As part of this, we have presented the first-ever listing of India's Top 20 Home-grown Biotechnology Companies, to capture the true spirit of Indian entrepreneurship at its best. Together, these home-grown companies have done almost as well as a wider grouping of firms that also has foreign companies. The following pages capture the intricacies of the Indian biotechnology sector. The survey has covered the business details of 280 companies which are active in the modern biotechnology segment. There are also details about 108 BioSuppliers who are integral to the growth of the biotech companies by providing the highly specialized products and services that are essential to the growth of the industry. sureshn@cybermedia.co.in ]]> <![CDATA[20. Biological E]]> https://biospectrumindia.com/news/95/6456/20-biological-e.html https://biospectrumindia.com/news/95/6456/20-biological-e.html Wed, 15 Jun 2005 14:46:00 +0530 CEO: Dr Vijay Kumar Datla Booster Shots Biological E has been consistently growing at an overall rate of 12 percent in the past two years T he total turnover of Biological E during 2004-05 was Rs 101 crore, up from Rs 90 crore in the previous year. The company's product range covers bulk drugs, sera and vaccines, oncology, biological and formulations both branded and generic. However, its biotech revenue for was Rs 36.25 crore, a shade lower than Rs 38.37 crore in 2003-04. This dip is mainly on account of its lower turnover, as compared to the previous year, from its biochemical business. But the vaccine business of Biological E is growing rapidly and has registered a 46.5 percent increase, from Rs 19.13 crore in 2003-04 to Rs 28.19 crore in 2004-05. A major chunk of this revenue, Rs 24.46 crore was through the sale of DPT, TT vaccines to the National Immunization Program (NIP). The company has been associated with NIP for the past 30 years. Last year marked the entry of Biological E in the recombinant hepatitis B vaccine market. The company launched "Bevac", its r Hep B vaccine, during the year after receiving the regulator's approval for its commercial manufacturing. Bevac grossed Rs 1.33 crore in its maiden year. Biological E plans to consolidate its standing in the vaccine segment and its new vaccines facility, a modern 200,000 sq ft building, at the second phase of Shapoorji Pallonji Biotech Park at Shamirpet, would manufacture combination vaccines like DPT and Hepatitis B. The plant would be compliant with the standards of regulatory bodies like WHO-GMP, USFDA, UK-MHRA, Australia - TGA etc, besides the Indian Schedule M-GMP. This would help the company enter the foreign markets and also supply its vaccines to international institutional purchasers such as UNICEF. In view of these plans, Biological E has been investing heavily in the company, nearly 36 percent of its total turnover. It invested Rs 36.1 crore last year. Of this Rs 35 crore went into the infrastructure development and Rs 1.1 crore on R&D. During the current year, it plans to raise this figure by 22 percent, investing a total of Rs 44 crore, most of it on infrastructure. In order to further strengthen its vaccine portfolio, Biological E had recently signed an agreement with Intercell AG, a US-based biotechnology company, for the development, manufacture and sale of its new vaccine, Japanese Encephalitis (JE), in Asia. According to the agreement, Biological E will manufacture the product in India for the Asian endemic market, while Intercell AG would concentrate to market the product in the US, Europe and Australia. The company already has technical collaborations with IMTECH, Chandigarh, Indian Institute of Science, Bangalore for products in the area of bacterial vaccines and recombinant therapeutics. It also has a technical tie-up with NIV, a government institute in Netherlands, for launching new vaccines like Hib for influenza. Leveraging its strong vaccine portfolio, the company expects to increase its biotech income to about Rs 44 crore, while aiming to clock a total turnover of Rs 120 crore during the current fiscal. The company is targeting specialty and high-tech products for oncology, anti-TB, cardiology sera and vaccines etc. It also plans to make inroads into gynaecology and paediatric segments with more novel formulations. The company would be shortly launching new products in the antibiotics segment. Biological E was started in 1953 and it deals in critical healthcare products such as preventive immunologicals making them accessible to common man. It has strong presence in sera and vaccine, oncologicals, bulk drug, formulations and herbal products. ]]> <![CDATA[18. Bharat Biotech International]]> https://biospectrumindia.com/news/95/2559/18-bharat-biotech-international.html https://biospectrumindia.com/news/95/2559/18-bharat-biotech-international.html Wed, 15 Jun 2005 14:41:00 +0530 CEO: Dr Krishna Ella On Growth Path Bharat Biotech has recorded strong growth of nearly 20 percent in 2004-05 A nother biotech industry bell weather, Hyderabad-based Bharat Biotech International Ltd ( BBIL) has recorded strong growth of nearly 20 percent in 2004-05. It has posted sales of Rs 41 crore in 2004-05 with a growth rate of 19.4 percent against last year's sale of Rs 36 crore. Bharat Biotech has notched up some other successes too in the past year. This multi-dimensional biotechnology company specialized in product-oriented research and development and manufacturing of vaccines and bio-therapeutics and has got the approvals in January 2005 from the Korean Food & Drugs Administration for its human vaccines manufacturing facility located at Genome Valley in Hyderabad. This enables BBIL to attain a level playing field and help reposition its entry into the global markets in the sphere of injectibles. BBIL is mainly involved in three activities such as the development and production of vaccines, contract development and manufacturing for western-based pharma/biotech companies, and the development of its own line of molecules. Bharat Biotech has entered into a contract-manufacturing tie-up with multinational Wyeth Lederle for pneumonia vaccine. Bharat Biotech has signed a joint venture agreement with South Africa's gold and diamond company Mvelaphanda Holdings in 2004, set up a manufacturing plant for vaccines and generic drugs near Johannesburg. Under the agreement both Bharat Biotech and Mvelaphanda would have equal stake. South African plant would be set up at an investment of Rs 125-150 crore. Bharat Biotech has a state-of-the-art manufacturing plant spread over 22 acres campus at Genome Valley, Hyderabad. It was established with an investment of over Rs 100 crore. The equipment, the procedures and the practices, meet the stringent quality standards laid down by world renowned quality monitoring institutions including USFDA, UKMCA and WHO norms. BBIL is the first of its kind biotech company in the country to have received grants from Children's Vaccine Program (CVP) through Program for Appropriate Technologies for Health (PATH) (Bill & Melinda Gates Foundation) for developmental work on Rota vaccine and malaria vaccine. Besides it has notched up several firsts to its credit. In recognition of its efforts, BBIL has been the first to receive three collaborative research grants from the Department of Science and Technology, Government of India and has received a number of awards including the National Award for 'Best Biotechnology Company' by the All India Biotech Association, the National Award for 'Best R&D Efforts in Industry' by the Department of Scientific and Industrial Research (DSIR), Government of India, the Award for 'Best Technological Development in R&D by an Industrial Scientific Organization' from FAPCCI. BBIL Chairman Dr Krishna Ella was the first BioSpectrum Entrepreneur of the Year in 2003. Bharat Biotech has also been awarded Sir M Visvesvaraya Industrial Award for Best Technology Effort (Biotechnology) for HIMAX Technology by All India Manufacturers Organisation, Andhra Pradesh State Board for the year 2004. The HIMAX Technology has played a vital role in bringing down the cost of the production of Hepatitis-B vaccine making it affordable for millions across the country and for other developing countries. More than 40 million doses of Revac-B, Hepatitis B vaccine have been dispensed in India, Latin America and in Africa. BBIL has set up a foundation called Bharat Biotech Foundation, which has been recognized by the Jawaharlal Nehru Technological University (JNTU), Hyderabad to execute academic research and promote scholastic excellence through a doctoral program in biotechnology. ]]> <![CDATA[17. Bharat Immunologicals & Biologicals Corporation]]> https://biospectrumindia.com/news/95/3565/17-bharat-immunologicals-biologicals-corporation.html https://biospectrumindia.com/news/95/3565/17-bharat-immunologicals-biologicals-corporation.html Wed, 15 Jun 2005 14:40:00 +0530 CEO: UN Behera Turning Around BIBCOL has made a nominal profit in 2004-05 after few consecutive years of losses S miles are back at this government-owned polio vaccine maker near Delhi. BIBCOL, the publicly traded vaccine maker run by the Department of Biotechnology (DBT) has made a nominal profit in 2004-05 after few consecutive years of losses. The company achieved a turnover of Rs 53.25 crore during the year 2004-05 against the turnover of Rs 21.59 crore during the previous fiscal year. Significantly, the company has earned a net profit of Rs 0.93 crore for the first time during the year 2004-05 against the loss of Rs 3.14 crore (before taking the impact of extraordinary items) in 2003-04. This has been possible due to extensive restructuring within the company. Bharat Immunologicals & Biologicals Corporation Ltd (BIBCOL) is a central public sector undertaking set up by the DBT under The Companies Act, 1956. It was incorporated in March 1989, to manufacture Oral Polio Vaccine (OPV) and other immunobiologicals under cGMP conditions as specified by WHO and Federal Standards. The company has been formulating OPV from bulk since January 1996 and about 1016 million doses have been supplied to the National Immunization Program (NIP) so far. BIBCOL went public in 1994 and presently there are about 22,000 shareholders in the company. The Indian government has 59.25 percent holding in the company. The shares of BIBCOL are listed in Mumbai, Delhi and Kanpur stock exchanges. The face value of the equity share is Rs 10 each while the present market price of the share is moving in a band of Rs 24 to 30. The company's equity share capital amounts to Rs 43.18 crore. The WHO-GMP certified facility of BIBCOL has a licensed/installed capacity for indigenous production of 100 million doses of OPV, where as the installed capacity for blending and filling operations is 600 million doses. During 2004-05, 120 million doses of OPV were formulated and supplied to the National Immunization Program (NIP), capturing nearly 60 percent of the market share of polio vaccines in the country. BIBCOL received the vaccine orders from the Department of Family Welfare, Government of India, which were supplied during the stipulated time. For the first time the company has signed a MoU with the DBT for the fiscal year 2005-06. The document outlines the targets set for BIBCOL and the commitments made by the parent organization towards the company. Commenting on the future strategy of the company, in view of the declining polio graph in the country, UN Behera, CEO, BIBCOL, stated, "As the incidence of polio is steadily declining in India, the company is looking towards manufacturing the Injectable Polio Vaccine (IPV) in the future in addition to the oral vaccine. We are also considering diversification into the production of other vaccines, nutraceuticals and diagnostics". BIBCOL is considering this expansion of product portfolio in its present facility. During the year 2005-06, the company is expecting to formulate about 100 million doses of OPV from bulk and supply to NIP. "During the current year, BIBCOL is aiming at further improving all the dynamic functional parameters, as the margins in vaccine manufacturing are very thin. The input-output ratio, project investment ratio, energy conservation, labor productivity, water conservation and harvesting are the important functions that would be fine-tuned", shared Behera. Till date, the company has invested Rs 12 lakh on R&D and Rs 38.9 crore on infrastructure development in its plant. It provides continuous training and skill upgradation programs to its employees. The total employee strength in BIBCOL is 125, which is likely to remain the same during the present year. ]]> <![CDATA[16. Wockhardt]]> https://biospectrumindia.com/news/95/2236/16-wockhardt.html https://biospectrumindia.com/news/95/2236/16-wockhardt.html Wed, 15 Jun 2005 14:39:00 +0530 CEO: Habil Khorakiwala Wosulin Boost Wockhardt, a leading pharma player, has consolidated its biotech sales during FY 05 Pharma major Wockhardt has strengthened its biotech sales for the year 2004-05. The sales from its biotech products for the year 2004-05 estimated at Rs 67 crore against last year's sale of Rs 40 crore. Its biotech sales is expected to reach Rs 100 crore for the year ending December 2005. During 2004 Wockhardt's Diabetology portfolio posted a 92 percent growth with Wosulin capturing 25 percent of new prescriptions. The neuro-psychiatry portfolio registered a 21 percent growth. Wockhardt has three products namely Biovac- B (hepatitis â€“B) vaccine, Wepox (erythropoietin) and Wosulin (rDNA human insulin) in its biotech portfolio. Wockhardt has consolidated its global revenue for the year ended December 31, 2004 at Rs. 1,239 crore registering a growth of 32 percent over the previous year and announced consolidated net profit of Rs. 214 crore, recording a 50 percent increase over 2003. Continuing its spree to launch newer products in biotechnology in February 2005, it launched Wosulin pen, India's first automatic insulin delivery device specially designed for the convenience of Indian diabetic patients. It has also launched a dedicated website for diabetics, www.wockhardtdiabetic.com, in nine Indian languages. In addition to marketing of the products, it is also working on developing new biopharmaceutical products at its new plant in Aurangabad, Maharashtra. About 80 scientists are working on breakthrough technologies in the area of biopharmaceuticals at this complex. Wockhardt has robust pipeline of products, which are at various stages of pre clinical and clinical trials. It has completed phase III clinical trials on interferon alpha 2b used in the management of cancer. Pre-clinical work has been completed on growth stimulating factors (GCSF) and on the breakthrough biotechnology product, Glargine, a new advance on insulin. This is the second such product in the world. Considering the growth of biotechnology products, Wockhardt has established a new strategic business unit to drive its biotechnology business during the tenure of Dinesh Dua as its president. Wockhardt has received 17 registrations for its biopharmaceuticals and 36 registrations are being pursued in various overseas markets such as Russia, South America, Central Asia, South East Asia and North Africa. It has formed majority joint venture in Mexico and South Africa and has set up a subsidiary in Brazil. In Mexico, Wockhardt has signed a joint venture agreement with Representaciones E Investigaciones Medicas, SA de CV, a leading company. Wockhardt Mexico SA de CV, 51 percent owned by Wockhardt and 49 percent by the local firm, will initially market all forms of insulin manufactured by Wockhardt. At a later stage, it will market other diabetology products and biopharmaceutical products. Wockhardt has also established a sales and marketing subsidiary, Wockhardt Farmaceutica do Brasil Ltda in Brazil to market its pharmaceutical and biopharmaceutical products. Wockhardt South Africa Pty Ltd, a 51:49 joint venture between Wockhardt and Pharma Dynamics, will use the regulatory, sales and marketing expertise of Pharma Dynamics to commercialize the growing pharmaceutical and biopharmaceutical portfolio of Wockhardt. Wockhardt has an active multi-disciplinary R&D program largely focused on developing innovative technologies and drug discovery. The company engaged in new drug discovery research and has several new chemical entities in the field of sepsis and anti-infectives. The Company's efforts in biotechnology have led to three successful brands-Biovac-B (Hepatities-B) vaccine, Wepox (erythropoietin) and Wosulin (rDNA human insulin). ]]> <![CDATA[15. Eli Lilly And Co. (India)]]> https://biospectrumindia.com/news/95/2643/15-eli-lilly-and-co-india.html https://biospectrumindia.com/news/95/2643/15-eli-lilly-and-co-india.html Wed, 15 Jun 2005 14:35:00 +0530 CEO: Rajiv Gulati Insulin Big Shot Lilly India had an overall 10 percent growth, while its biotech revenues increased marginally It was not a good year for Eli Lilly's biotech business in 2004-05. And the insulin war appears to have taken a toll. Though, its overall turnover registered a 10 percent growth in 2004 as compared to that in 2003, its biotech business for the same stood at 68.38 crore, with a marginal 1.5 percent increase from the previous year's revenue of 67.46 crore. The reason attributed for this slight growth is the increased competition in the human insulin segment, which accounts for the major chunk of its sales revenue. Due to the increased number of players in this segment the prices of the recombinant insulin have dropped sharply. In 2004 Lilly sold some 4,098,853 units of human insulin in the country and about 6000 units of Humatrope [Injection Somatropin-growth hormone] for growth hormone deficiency syndrome and Forteo [Injection Teriparatide] for severe osteoporosis. Eli Lilly and Company (India), a subsidiary of the US pharmaceutical major Eli Lilly and Company, was set up as a 50:50 joint venture between Eli Lilly and the Indian partner Ranbaxy Laboratories. After its inception in 1993, the Indian operation achieved a quick break-even in 1996. In August 2001, Eli Lilly and Company acquired the 50 percent stake from Ranbaxy Laboratories to create a 100 percent Lilly subsidiary, Eli Lilly and Company (India) Pvt. Ltd. Lilly India's growth curve has been steep; its revenues surged from a modest Rs 8 crore in 1994 to Rs 156 crore in 2004. During the current year the company plans to achieve a turnover of Rs 172 crore. In India, it operates with a 550-member team. This team is spread across the country and provides products and services to medical practitioners and hospitals. The indigenized rDNA human insulin, Huminsulin, which was earlier being imported in the fully finished form, is now being formulated at a Sun Pharmaceutical plant in Gujarat. In the area of diabetes management, in addition to Huminsulin, Lilly India has launched Humalog [Injection Insulin Lispro], fast acting insulin analog useful for diabetics with irregular or busy lifestyle; Humaject, a use-and-throw disposable insulin delivery device; HumaPen Ergo, a virtually painless way of injecting insulin; and Humacare, a complete customer service program launched in 2002 for diabetic patients. Its other products include Xigris [Injection Drotrecogin Alfa], the only treatment available for the reduction of mortality in adult patients with severe sepsis; Gemcite [Injection Gemcitabine] for the treatment of non-small-cell lung, pancreatic, bladder and breast cancer; Distaclor [tablet cefaclor], a broad-spectrum antibiotic to treat tough infections; and ReoPro [Injection Abciximab], a supportive therapy used during interventional cardio vascular procedures. Now with India embracing the product patent regime, the company is planning to introduce some more products in the country in the near future. The company is presently conducting approximately a dozen trials of its different products, which are in the various stages of development in India. Its annual investment in clinical research accounts for more than 8 percent of the sales turnover. Commenting on the performance of the company in FY 2004, Rajiv Gulati, CEO, Lilly India, said, "Our double digit growth this year although less than our last year's growth is still formidable considering that we divested a couple of Lilly brands in 2004, brands that were not part of our focus therapeutic areas.... we are pleased that the government has finally okayed the product patent law making it a reality...although there are chinks in the Act that needs some more review, it is still a big step in the right direction..." ]]> <![CDATA[14. Novozymes South Asia]]> https://biospectrumindia.com/news/95/2628/14-novozymes-south-asia.html https://biospectrumindia.com/news/95/2628/14-novozymes-south-asia.html Wed, 15 Jun 2005 14:34:00 +0530 CEO: GS Krishnan Growth Catalyst Novozymes is one of the biotech-based leaders in enzymes and microorganisms for industry use Novozymes is continuously expanding its frontiers of biological solutions to improve industrial performance. Headquartered in Denmark, Novozymes is a group company of Novo Nordisk. In India, the company is represented by Novozymes South Asia Pvt Ltd, located in Bangalore. Through its wide network of sales and marketing professionals, Novozymes South Asia is exploring the Indian market for the product range offered by the company. According to industry estimates, the company has clocked sales of nearly Rs 66 crore in India during 2004-05. Novozymes produces and sells more than 600 products in 130 different countries, the largest geographical markets being Europe, North America and Asia. Its products play an important role in the production of thousands of products from foods and textiles to cleaning and wastewater treatment. The biotech tools used by the company include gene technology, microbiological techniques and fermentation technology. The company currently employs more than 3,900 people in 30 countries. Enzymes and microorganisms for industrial use account for 95 percent and 5 percent of Novozymes' business respectively. The industrial enzymes are divided into three categories: technical enzymes; food enzymes; and feed enzymes. Technical enzymes include products for the detergent industry, the starch, textile, fuel ethanol, pharmaceutical, and various smaller industries. Food enzymes include products for the baking industry, the brewing, beverage alcohol industries and other food industries such as the dairy industry and the oils and fats industry. The industrial microorganisms business area includes sales of microorganisms for aquaculture, wastewater treatment, cleaning and biological plant care. Novozymes launched six new enzyme products in 2004, three of which are in the field of detergent enzymes. The company also launched its first biopolymer product for the cosmetics industry in 2004. It is currently working on projects in antimicrobial peptides, the development of low-allergenic proteins, and monoclonal antibodies, and is looking for external partners in all three areas. In the microorganism segment, through a series of acquisitions, Novozymes has become a world leader and will continue to expand in this field by introducing a series of new products and applications. During the year, its microorganisms business focused on integrating the acquired companies and generating organic growth. There were also two minor new microorganism products developed during the year. The company has an extensive patent portfolio with more than 4200 active patents, patent applications and licensed patents. And it is continuously seeking partners to license or in-license patents within the company's interest areas. Novozymes spends about 13 percent of its turnover on research and development. And around one tenth of its expenditure on R&D is used in new areas, in line with its strategy of building up new business areas beyond enzymes and microorganisms. In 2004 Novozymes launched its first biopolymer product, a hyaluronic acid called HyaCare for use in face creams and other cosmetic products. Novozymes is now exploring the possibilities of marketing HyaCare in other areas. In the pharmaceutical industry it has entered in an alliance with the Australian company Meditech, which is researching the use of hyaluronic acid in the treatment of cancer. There has also been an alliance with a Belgian company Solvay Pharmaceuticals, which aims to develop new products for patients whose pancreases cannot produce enough enzymes. ]]> <![CDATA[13. Shantha Biotechnics]]> https://biospectrumindia.com/news/95/2370/13-shantha-biotechnics.html https://biospectrumindia.com/news/95/2370/13-shantha-biotechnics.html Wed, 15 Jun 2005 14:30:00 +0530 CEO: KI Varaprasad Reddy Pioneering Spirit Shantha Biotechnics, had an extremely good year, registering an impressive 75 percent growth A n Indian biotech icon, Shantha Biotechnics, had an extremely good year in 2004-05, registering an impressive 75 percent growth in revenues. The company's total biotech turnover for 2004-05 was Rs 70 crore, up from Rs 40 crore the previous year, registering an impressive 75 percent growth. It has generated a major chunk of its revenues, Rs 61.80 crore, from the sale of its Hep B vaccine. Shantha sold about 160 million doses of Hep B vaccine during the year, 90 million doses in the domestic market and 70 million doses abroad. While the sale of therapeutics including erythropoietin, interferon, streptokinase and growth factors accounted for Rs 6.7 crore during the year 2004-05. Shantha Biotechnics, a pioneer in recombinant vaccines, was the first to develop, manufacture and market an indigenously developed r-DNA hepatitis-B vaccine. It commercially launched Shanvac-B (hepatitis B vaccine) in 1997, which was the first Indian hepatitis-B vaccine pre-qualified by WHO-Geneva. After ShanvacB, the company has launched a series of recombinant biotherapeutic proteins. It launched Shanferon in 2002, a recombinant human interferon alpha 2b; Shankinase in 2004, a recombinant streptokinase; and recently in January 2005, Shanpoetin, a recombinant human erythropoietin. Shantha's contract R&D services wing, offering cloning and expression of genes in various host systems, development and characterization of cell lines, fermentation and purification process development, etc generated revenues worth Rs 2 crore during the year. While the diagnostic kits (HIV, HBV and HCV) launched by the company fetched Rs 2 crore during the year 2004-05. Focusing on the pure play biopharma segment, it has developed technical collaborations with both Indian and foreign research institutes. Shantha has an agreement with IVI, Korea for technology transfer of typhoid vaccine; National Institute of Immunology, New Delhi for controlled release Hepatitis-B vaccine, Indian Institute of Science, Bangalore for anti-malarial drugs; Bhabha Atomic Research Centre, Mumbai for plant-based vaccines and Polytherics Ltd, London, UK for Pegylation technology for developing Pegylated Interferon. It has a significant pipeline of products in segments like Vaccines: Basic pediatric and enhanced pediatric vaccines, Combination, adult and travel vaccines; Therapeutic Products: Tissue Plasminogen Activator, Anti GP IIb/IIIa, Human Insulin, Peg Interferon, TNF Alfa; Oncology Products: G-CSF, human monoclonal antibodies RM I, RM II, RM III, RM IV, Anti EGFR; Diagnostic Kits: AFP Elisa, Hepatitis B Elisa, Hepatitis C Elisa and HIV I+II Elisa. Presently, Shantha has five patents to its name and its total employee strength is 526 people, which is expected to increase to 745 during the next year. An R&D driven company, it has ploughed back more than 25 percent of its revenues, till date into R&D activities. During 2004-05, it made a total investment of Rs 60 crore in the company. Its R&D center spread over 40000 sq ft and its R&D efforts are mainly focused on therapeutic products for oncology and on vaccines. The company's manufacturing facility meets WHO cGMP and US FDA Standards. Exports account for a major part of Shantha's revenue. During FY05, 69 percent of its revenue was through exports, Hep B being the major product. It caters to international markets including Asia-Pacific, Africa, CIS and Latin America in addition to supplies to Global Organizations like UNICEF and PAHO. Shantha has a subsidiary, Shantha West Inc. in San Diego, US, which is engaged in basic research in monoclonal antibodies for therapeutic applications in the oncology segment. ]]> <![CDATA[12. Indian Immunologicals]]> https://biospectrumindia.com/news/95/1168/12-indian-immunologicals.html https://biospectrumindia.com/news/95/1168/12-indian-immunologicals.html Wed, 15 Jun 2005 14:28:00 +0530 CEO: KV Balasubramaniam Surging Ahead Indian Immunologicals has grown at the rate of 27.6 percent in the animal vaccine market I ndian Immunologicals Ltd (IIL) has been doing well in the animal vaccines segment with a growth rate of 27.6 percent and sales reaching Rs 72.38 crore in 2004-05. Of the total sales turnover of Rs 81.48 crore in 2004-05, IIL's biotech sales contributed Rs 72.38 crore against last year's biotech contribution of Rs 56.7 crore. IIL's total sales turnover for 2003-04 stood at Rs 65.76 (including Rs 56.7 crore from biotechnology products) against Rs 54.67 crore (Rs 46.13 crore) in 2002-03 and Rs 36.66 crore (Rs 26.52 crore) in 2001-02. Considering the market potential IIL has been making investments in infrastructure in the last few years. From Rs 11.74 crore in 2002-03, it has increased its investments to Rs 50.24 crore in 2004-05, an increase of about Rs 17 crore over last year's investments on infrastructure. In addition to this, IIL has also doubled its investments on R&D up from Rs 2.78 crore in 2003-04 to Rs 4.05 crore in 2004-05. Similarly it increased its head count by 103 last year from 514 in 2003-04 to 617 in 2004-05. Of them, 28 people are into research and 314 are in sales. So far it has filed seven international patents on novel combination DNA rabies vaccine. One patent has been granted so far. Indian Immunologicals, a new entrant in the human biological market, is a wholly owned subsidiary of the National Dairy Development Board (NDDB). IIL was set up in 1983, under the "Operation Flood" program to meet the growing demand for Foot and Mouth Disease (FMD) vaccine in India. NDDB has a equity of Rs 9 crore in IIL, the first and only veterinary biological unit in India to obtain both ISO 9002 and Good Manufacturing Practices (GMP) certification as per World Health Organization (WHO) GMP guidelines. IIL has a set up modern plant at Hyderabad with technology from the UK-based Wellcome Foundation. This plant has an installed production capacity of 25 million quadrivalent doses of FMD vaccine that makes it the second largest plant in the world. Indian Immunologicals is one of the top 10 animal health companies in the world and is a key player in veterinary biologicals, manufactures a wide range of veterinary biologicals, animal health products and feed additives required by the veterinary profession. IIL's range of products fall under following categories biologicals, dewormers, general formulations, diagnostics and other group. Its products conform to the standards laid down under the Indian/British Pharmacopoeia (veterinary). Apart from domestic sales, IIL also exports its products, especially vaccines, to several countries in Asia, Middle East, Africa and Cyprus in Europe. Recognizing the volume of exports to a large number of countries, it bagged the second best exporter award in the commodity group Drugs Pharmaceuticals and Chemicals for the year 1999-2000. To reach the larger farmers' base across the country Indian Immunologicals has divided its domestic operations into three strategic business units: Institution (government, co-operatives/milk-unions), Livestock and Petlife, the last two SBU's focus on prescription and retail markets while the former caters to institutional business. IIL has distribution points at 16 locations in India. This is supported by a network of stockists and retailers. Indian Immunologicals not only offers veterinary products to farmers but has also adopted many innovative methods to educate veterinarians, extension workers, and farmers on vaccination through interacting and audio-visual techniques. ]]> <![CDATA[11. GlaxoSmithkline]]> https://biospectrumindia.com/news/95/1257/11-glaxosmithkline.html https://biospectrumindia.com/news/95/1257/11-glaxosmithkline.html Wed, 15 Jun 2005 14:22:00 +0530 CEO: S Kalyanasundaram Vaccine Leader Glaxo has so far covered one fourth of the Indian vaccine market GSK Vaccines , a subsidiary of global pharma giant, GSK has emerged as the undisputed vaccine leader in the country last year. With a field force of 150 and a strong product portfolio (11 vaccines for both adult and paediatric), its sales stood at Rs 77.8 crore for the year ending March 31, 2005 . The company is growing at a rate of about 25 percent each year. It has so far covered one fourth of the Indian vaccine market. And it is now focusing on taking away the un-represented or grey market, which is close to 40 percent. GlaxoSmithKline (GSK) Vaccines, was the first company to introduce Hep B, Hep A, chickenpox vaccine, meningitis and a combination vaccine of DPT â€“ HB/Hib in India. GSK Vaccines is a part of the GlaxoSmithKline Pharmaceuticals Ltd that commands a 6.5 percent market share by retaining its No.1 position in the Indian Pharmaceuticals Market (source ORG IMS Stockist Audit December MAT 2004) in 2004. Its net sales of the pharmaceuticals business segment in 2004 was Rs 1158 crore with a growth rate of 8.7 percent over the previous year. After starting with marketing of vaccines in India, GlaxoSmithKline is now coming up with a state-of-the-art vaccines filling facility at Nasik conforming to international current Good Manufacturing Practices (cGMP) norms. The foundation for this plant was laid in February 2005 and is expected to be fully operational by early 2006. This facility will be GSK's first manufacturing site to co-house a pharmaceutical and vaccine manufacturing. The plant is being built to cater to Indian market needs, which could be expanded to meet the requirements of neighbouring countries. The setting up of this plant demonstrates GSK's commitment to the people of India. With growing competition from the local low priced products GSK Vaccines has now initiated novel concepts to bring awareness on use of vaccines in the country. It has launched a novel concept of "Famili Vaccines", which is an immunization awareness initiative launched last year. GSK Vaccines has also launched 'Koi Hai', an education program on Hepatitis A in 2005. This education program aims at creating awareness and educating the public on the disease, thereby enabling people to protect themselves against it. This program entails social interventions at the workplace, in schools and in clinics that reach out to the various segments of audiences. GSK Vaccines has introduced two new vaccines "Fluarix" and "Priorix" during 2004. GSK Vaccines also launched 'Mencevax ACWY', the first and only meningitis vaccine available in India. GSK has been supplying the vaccine to the Government of India for the past three years and has now made it available to the private market as well. GSK India is supporting the GSK Biologicals in its vaccines development process through its clinical data management center based at Bangalore for the last 10 years. Now GSK Biologicals is looking at developing India a global hub for clinical research and development. GSK has lined-up global trial of four vaccines - two vaccines for rotavirus, one for cervical cancer, and a combination DTP vaccine in India during 2005. Prevention is, after all, better than cure and nobody knows that better than vaccine manufacturers. This belief helped GSK Vaccines to achieve the market leadership in India and continue to play a major role in serving the people better. It has three manufacturing units in India located at Thane, Nasik and Mysore. The 2000 strong field force, backed by a nation wide network of over 4000 stockists, ensures that the products are readily available across the nation. This combined with the quality of the products means that GSK is able to offer superior solutions. ]]> <![CDATA[10. Chiron Behring Vaccines]]> https://biospectrumindia.com/news/95/1410/10-chiron-behring-vaccines.html https://biospectrumindia.com/news/95/1410/10-chiron-behring-vaccines.html Wed, 15 Jun 2005 14:18:00 +0530 CEO: Ganesh S Dhamdhare Unhindered Growth Chiron Behring has increased its sales by 16 percent during the year It was a year of smooth sailing for the Indian arm of this MNC which was hit by the flu vaccines crisis in 2004. The wholly-owned subsidiary of Chiron Corporation, Chiron Behring Vaccines Pvt Ltd (CBVPL) was established in 1989 under the flagship of erstwhile Hoechst India Ltd and in 1998 it was taken over by Chiron Corporation. With work force of over 75 CBVPL was able to make sales of Rs 78 crore for the year 2004-05 registering a 16.4 percent growth against last year's sales of Rs 67 crore. It is growing at the rate of 15 percent every year. The CBVPL is a joint venture company in which another global pharma major, Aventis has 49 percent stake. As per the agreement, CBVPL will manufacture Rabipur - anti rabies vaccines for Aventis Pharma upto April 2008. It has a technical collaboration with Chiron Corporation. During the year it has entered into a strategic alliance with Panacea Biotec, New Delhi. The new joint venture company, Chiron Panacea Vaccines, will focus on providing new breakthrough vaccines in India. Both Panacea and Chiron are investing $1 million in this joint venture. This joint venture company is the first to develop the breakthrough fully liquid Pentavalent combination vaccine, which will protect against five potentially life threatening infectious diseases: diphtheria, tetanus, whooping cough, Hepatitis-B and H.Influenzae type b, which is a major causative bacteria for pneumonia and meningitis. Chiron Behring has a registered office in Mumbai for registration, marketing and sale of its products and has a manufacturing facility at Ankleshwar in Gujarat. This facility is located at Aventis Pharma's manufacturing unit. The plant is one amongst the few in the world to be pre qualified by WHO, Geneva for supply of anti rabies vaccines to UN countries. It has certification from MCC South Africa for supply of anti rabies vaccines to African countries. Besides it exports to Asia Pacific countries including Thailand, Sri Lanka, Bangladesh, Philippines, Vietnam, and Egypt. It is looking at consolidating its presence in India. Chiron Vaccines is the world's fifth largest vaccines company and has its headquarters in Oxford, UK, with facilities located throughout Europe, the US and Asia. The company is the world's second largest manufacturer of flu vaccines, and has important meningitis, paediatric and travel vaccine franchises. It is the leading vaccine manufacturer in the UK, Germany, Italy and India. Its portfolio of products includes vaccines for influenza, meningitis C, yellow fever, rabies, tick borne encephalitis, haemophilus influenzae B (Hib), polio, mumps, measles and rubella (MMR) and diphtheria, tetanus and pertussis (whooping cough). It has been at the forefront of medical revolution for nearly 100 years, and the company remains as one of the key players in the field of vaccines. In addition to its current product range, Chiron Vaccines is investing to improve existing vaccines, and to develop new vaccines to protect against diseases for which none currently exists, such as meningitis B and HIV. Besides manufacturing it is also involved in the development of newer vaccines. It has a very interesting pipeline that will allow it to strengthen its position in flu and meningitis prevention, where it could be the only company to provide a range of vaccines covering all the relevant meningococcal strains. It has as many as seven products (three in meningococcal disease and four in viral infection) at different stages of development from Phase I to Phase IV trials. ]]> <![CDATA[9. Bharat Serums and Vaccines]]> https://biospectrumindia.com/news/95/6789/9-bharat-serums-and-vaccines.html https://biospectrumindia.com/news/95/6789/9-bharat-serums-and-vaccines.html Wed, 15 Jun 2005 14:14:00 +0530 CMD: Dr Bharat Daftary Value Enhancer in Biotech Bharat Serums has increased its sales marginally, by 1.6 percent, during 2004-05 Bharat Serums and Vaccines Ltd (BSV) has marginally increased it biotechnology sales in 2004-05 to Rs 81 crore from last year's sales of Rs 79.68 crore. The sales from its biotech/biological products for the year 2004-05 has registered a growth of just 1.65 percent to Rs 81 crore over last year's sale of Rs 79.68 crore. For the year 2002-03, its sales stood at Rs 72.37 crore. The company has been doing well in terms of its financial results by improving its sales from Rs 46.41 crore in 2000-01 and Rs 57.34 crore in 2001-02. In 2003â€“04, it introduced streptokinase, urokinase, and low molecular weight heparin, anti-rabies serum and anti-thymocyte globulin. Bharat Serums and Vaccines is a company floated by Dr Vinod G Daftary .The BSV has significant R&D activities with a focus on biopharmaceuticals, novel drug delivery systems and equine products. BSV is one of the fast growing pharmaceutical companies in India with a CAGR of more than 50 percent in the last three years It has developed its competency in the areas of NDDS and in development and purification of equine-based therapeutic products. Since its inception in 1971, BSV has worked ceaselessly to research, develop, manufacture and market specialized biological, pharmaceutical and biotechnology products. Its product portfolio comprises of a wide range of products such as plasma derivatives, monoclonals, hormones, equine antitoxins and serums, antifungals, anaesthetics, cardiovascular and diagnostic products. Bharat Serums and Vaccines is investing about seven percent of its total revenue in R&D infrastructure including high quality laboratory facilities, experienced research scientists and personnel. The R&D activities have been granted recognition by the Department of Scientific and Industrial Research. The University of Bombay has also granted recognition to its R & D laboratory as a center for Postgraduate and Doctoral research in Microbiology, Applied Biology and Biochemistry. It also got the approval and accreditations from WHO and DGCI to manufacture pharmaceutical products. BSV has distinct R&D divisions working extensively on new drug delivery systems and biotechnology. The thrust of the R&D in the previous years has been on novel drug delivery systems (especially injectibles) in the areas of anaesthesia, anti- fungals and oncology. On biotechnology front the team has been working on developing new generation recombinant therapeutics that replaces the traditional plasma products, which are in short supply worldwide due to the dependence on human donors, and runs the risk of viral infections like HIV etc. BSV manufactures and markets plasma, pharma and biotechnology products. It was primarily set up to export plasma derivatives to US, Europe and Japan. Today, BSV has developed considerable market strengths in the domestic markets through its portfolio of niche primary line, life-saving injectibles. It remains focused on ascending the value chain in the manufacturing and marketing of biological, pharmaceutical and biotechnology products and is committed to enhancing the sales of these products. BSV has in its portfolio over 25 brands, most of them having the potential of being a product capable of being marketed in the global market. Exports would continue to propel its growth in the coming years. The group has promoted ventures in clinical research, diagnostics and therapeutic enzymes through other associate ventures. ]]> <![CDATA[7. Rasi Seeds]]> https://biospectrumindia.com/news/95/1735/7-rasi-seeds.html https://biospectrumindia.com/news/95/1735/7-rasi-seeds.html Wed, 15 Jun 2005 14:08:00 +0530 Managing Director: M. Ramasami New BioAgri Star Rasi seeds, has notched up sales of Rs 86.86 crore in its maiden year T he second entrant to the most-watched Indian Bt cotton market, Rasi Seeds has set the market on fire. In the 2004-05 cropping season, Rasi Seeds has notched up sales of Rs 86.86 crore. And now it is looking at tripling its sales in 2005-06. With a work force of 408 (including 62 researchers, 109 sales and marketing and 157 manufacturing personnel) Rasi Seeds, had sales of Rs 86.86 crore in 2004-05. With expected rise in the sale of Bt cotton hybrids in 2005-06 Rasi Seeds is anticipating its sales to reach Rs 250 crore during 2005-06. This agri-focused company with commitment to work for the Indian farmers has been investing to tune of Rs 30 lakh in R&D and infrastructures in 2005-06 against last year's investments of Rs 7 lakh. In addition to this it has also increased its head count in 2004-05. Rasi Seeds has released its first transgenic RCH 2 Bt cotton hybrid for commercial cultivation for central and south zones and became the second company to release transgenic Bt cotton in India after Mahyco-Monsanto Biotech (India) Ltd in 2004. This year its Bt cotton hybrids RCH 134 and RCH 317 (north zone), RCH 118 Bt, RCH 138 Bt and RCH 144 Bt (central zone) and RCH 20 Bt and RCH 368 Bt (south zone) have received the regulator's approval for commercial cultivation. Evolved from a small company, Rasi Hybrid Seeds that was envisioned and initiated by M Ramasami in 1973 at Attur in Tamil Nadu, it has made rapid advances from seed production and supply to a commendable position in R&D as Rasi Seeds with the contribution of R Krishnamurthy, a renowned cotton breeder of India. This flagship company has slowly, yet steadily emerged as one of the largest agribusiness groups in India. Its research products covered 7.5 million acres in the past decade. Rasi Seeds has been recognized as the leader in cotton hybrids, besides other crop hybrids in maize, pearl millet and vegetables. When the company launched its first set of research cotton hybrids namely RCH 1 and RCH 2 in 1992, it received good response from farmers' community. RCH 2 cotton hybrid is one among the very few proprietary research hybrids that has been notified by the Government of India. It has developed insect-protected cotton hybrids with the Bt gene under license from Monsanto. It has well-maintained research farm of 140 acres, green houses, a state-of-the-art seed processing plant and a high volume (HVI) fibre-testing laboratory. It has developed a modern high throughput biotech facility for molecular biology and transgenic crop production and also an insect-rearing and bioassay facility for assisting biotechnological research. In collaboration with the International Crops Research Institute of Semi Arid Tropics (ICRISAT), Rasi Seeds is engaged in the development of pearl millet hybrids with high yield, downy mildew resistance and good grain quality, and fodder to suit the major pearl millet growing regions in the country. Rasi Seeds is looking at intensifying its biotech research to cater to the need of the farmers by adopting novel and viable technologies. These include transgenic crops production with desirable agronomic traits such as virus resistance, pest resistance, tolerance to drought and others in different crops including cotton. Rasi will adopt efficient tools such as DNA marker technology in its crop breeding in combination with conventional approaches. This will result in the development high yielding superior crop cultivars with increased production and thus high income to the farmers. ]]> <![CDATA[6. Novo Nordisk India]]> https://biospectrumindia.com/news/95/1730/6-novo-nordisk-india.html https://biospectrumindia.com/news/95/1730/6-novo-nordisk-india.html Wed, 15 Jun 2005 14:05:00 +0530 CEO: Anil Kapur A World Leader in Diabetes Care The biotech income of Novo Nordisk is estimated to have grown by 22.7 percent in 2004-05 T he heat is on the leader in the insulin segment. Competition from two home-grown players, Wockhardt and Biocon, has started to put pressure on the prices of insulin. The biotech income of insulin leader, Novo Nordisk is estimated to have grown by only 22.7 percent in 2004-05, from Rs 110 crore to Rs 135 crore. Now Novo Nordisk plans to strengthen its diabetic care presence in India by introducing haemostasis management. The company plans to cover red blood cell transfusion, reduce complications like multiple organ failure and acute respiratory distress syndrome besides others. It is working towards launching NovoSeven, a recombinant Factor Vlla for treatment of bleeds in haemophilia A and B patients with inhibitors, in India by the year-end. Currently, the drug is undergoing clinical trials in select cities. Presently after getting the necessary approvals, the drug is in active use in the US and Israel. In India, Novo Nordisk is conducting trials at Fortis Hospital in Delhi and at a few hospitals in Hyderabad and Chennai and is expected to hit the market by end of this year after all necessary guidelines are completed. This recombinant protein is expressed from cloned human FVII genes in baby hamster kidney cells. Consolidating on haemostasis management, the company has announced plans to open a Haemostasis Research Center in New Jersey. Scheduled to open in the third quarter of 2005, the 30,000 sq. ft facility represents a major expansion of Novo Nordisk's research in the area of haemostasis. The new center will focus primarily on discovering new pharmacological targets for haemostasis and related complications. Novo Nordisk is a focused healthcare company with headquarters in Denmark. The company was created in 1989 through a merger between two Danish companies â€“ Novo Industri A/S and Nordisk Gentofte A/S. With a broad diabetes product portfolio, including the advanced products within the area of insulin delivery systems, Novo Nordisk is among the world leaders in diabetes care. In addition, it has a leading position in areas such as haemostasis management, growth hormone therapy and hormone replacement therapy. Novo Nordisk set its base in India in 1990 when a liaison office of NovoNordisk A/S, was set up in Mumbai. Prior to this Novo Nordisk A/S products were marketed in India through various other companies. In April, 1994, Novo Nordisk (I) Pvt. Ltd. was set up with its headquarters in Bangalore. It was later rechristened as Novo Nordisk India Pvt Limited. Since then the company has grown in stature. Now as an established healthcare company in India, its therapeutic portfolio comprises of diabetes, human growth hormone and haemostasis management. The company relies on biotechnology in the development of its successful products. These are human insulin, insulin apart, insulin detemir, growth hormone, FVIIa and glucagan. The company's ability to master protein expression in bacteria, yeast and mammalian cells is complemented by similar cutting edge capabilities within protein drug delivery. The above three set of competencies - research in diabetes, protein and their delivery form the basis for R&D strategy which aims at providing diabetes care leadership. In India in order to understand the needs of its customers better in each geographic area - North, East, West and South, the company has established regional offices in New Delhi, Kolkata, Mumbai and Chennai respectively. ]]> <![CDATA[5. Mahyco-Monsanto Biotech]]> https://biospectrumindia.com/news/95/7495/5-mahyco-monsanto-biotech.html https://biospectrumindia.com/news/95/7495/5-mahyco-monsanto-biotech.html Wed, 15 Jun 2005 14:04:00 +0530 CEO: Dr MK Sharma Cotton Maker Mahyco-Monsanto Biotech has increased its sale of Bollgard by six fold in 2004-05 M ahyco-Monsanto Biotech (India) Ltd (MMB) continued to rule the agribiotech space by increasing its sale of Bollgard, a Bt cotton hybrid seed by six fold in 2004-05 with sales of Rs 166.4 crore registering an impressive growth of 207 percent over the previous year. MMB had sales of Rs 166.4 crore with sale of 10.4 lakh packets of Bollgard each costing Rs 1600 (out of 13 lakh packets sold during the year) and the rest was from Salem-based Rasi Seeds. The sale of Bt cottonseeds is expected to triple during the current financial year from last year's sale of 13 lakh packets to about 40 lakh packets. MMB - a 50:50 joint venture between Maharashtra Hybrid Seeds Corporation (Mahyco) and Monsanto India Ltd is into marketing of Bacillus Thuringiensis (Bt) cotton hybrid seeds (Bollgard) developed by Mahyco since 2002. MMB has sold 72,000 packets of the three approved Bollgard hybrids - MECH 162, MECH 12 & MECH 184 - in the first year of its launch in2002. In 2003, the sale of Bollgard cotton increased three-fold to 230,000 packets. In 2004, Bollgard sales rose to 13 lakh packets, a six-fold increase over the previous year. About 350,000 farmers planted Bollgard in India in 2004. With each 450-gm packet required to cover an acre costing Rs 1,600 for the farmer, the total business from Bollgard would be in the range of Rs 208 crore last year. With a negative feed back from some parts of the country specifically from Andhra Pradesh, MMB has commissioned a study involving interviews with 3,199 farmers from 295 villages of 58 talukas and 20 districts of major cotton-growing states in the first quarter of 2005. The study conducted by IMRB reveals that the average per acre spending on pesticides by farmers across the country worked out to only Rs 275 for Bt cotton against Rs 1,412 for non-Bt cotton. And the overall average savings in spending on pesticides came to about Rs 1,200 per acre, with the number of sprays coming down from 6.24 to 1.73 on account of farmers opting for Bt cotton. Considering the potential of Bt cotton many Indian seed companies have become sub licensees of MMB. It has sub-licensed the Bollgard II gene construct to Rasi Seeds, Ankur Seeds Pvt Ltd (Nagpur), Krishi Dhan Seeds Ltd (Jalna) and Emergent Genetics India Pvt Ltd, Hyderabad. These companies have incorporated the gene construct into their respective cotton hybrids. MMB has sub-licensing agreements for its Bollgard technology with 21 domestic seed players, including the five who have opted for the improved Bollgard II versions. Of the remaining, 10 companies are from Hyderabad. Others include Namdhari Seeds Pvt Ltd (Bangalore), Tulsi Seeds Pvt Ltd (Guntur), Ajeet Seeds Pvt Ltd (Aurangabad), Vikram Seeds Pvt Ltd (Ahmedabad), Solar Agrotech Pvt Ltd (Rajkot) and Proagro Seed Company Pvt Ltd (Delhi). Seven of the 10 seed companies based at Hyderabad led by Nuziveedu had formed a consortium-Swarna Bharat Biotechnics-to enter into an agreement with the National Botanical Research Institute (NBRI), Lucknow, for commercializing Bt cotton technology to combat the multinational dominance. But now all have became sub-licensees of MMB. The Genetic Engineering Approval Committee finally gave green signal for cultivation of Bt cotton for the current kharif season against the wishes of the non- governmental agencies in May 2005. But Mech 162 and Mech 184 both from Mahyco failed to get the approval for cultivation in Andhra Pradesh for the current kharif season due to failure of the crop in many places in the state. Besides the first three Mahyco has received green signal from GEAC for commercial cultivation of MRC 6304 and MRC 6301 (north zone) MRC 6301 (central zone) and MRC 6322, MRC 6918 (south zone).    ]]> <![CDATA[4. Venkateshwara Hatcheries]]> https://biospectrumindia.com/news/95/6529/4-venkateshwara-hatcheries.html https://biospectrumindia.com/news/95/6529/4-venkateshwara-hatcheries.html Wed, 15 Jun 2005 13:35:00 +0530 Chairperson: Anuradha Desai Triple Jumper Venkateshwara Hatcheries has registered a growth of over 100 percent in 2004-05 from its poultry vaccines I t was raining vaccines in the poultry sector last year. What better evidence than the 100 percent growth recorded by the country's leading poultry vaccine maker, Ventri Biologicals. It is the vaccines division of the Venkateshwara Hatcheries (VH) Pvt Ltd, the flagship company of VH Group that was founded in 1971. It is the first Indian company to embark on a process of developing the poultry industry on scientific lines. It has registered a three-digit growth of over 100 percent in 2004-05 from its poultry vaccines against sales of Rs 88 crore in 2003-04. Its vaccine turnover including AHP has reached Rs 188 crore for the year ended on March 31, 2005. It includes 15 percent exports (accounts Rs 27.9 crore) and five percent of internal sales (accounts 9.3 crore). It is expecting its sales to reach Rs 250 crore in 2005-06. Backed by extensive and modern research and development facilities, Ventri Biologicals is constantly engaged in developing new generation vaccines, to combat emerging bacterial and viral diseases. It aims at providing better solutions for poultry health by manufacturing vaccines using state-of-the-art technology and sophisticated Research and Development facilities. It works in close association with Poultry Diagnostic and Research Centre (PDRC). Ventri Biologicals produces live and inactivated viral vaccines using complex cell culture and egg adapted technology with highly immunogenic vaccine virus strains in sterile atmosphere, using Specific Pathogen Free (SPF) eggs. Its vaccines conform the standards set by British Pharmacopeia and other international organizations. It produces over 10 million eggs per annum. For bacterial inactivated vaccines it has adopted the most advanced programmed biofermentation technology. Ventri Biologicals provides a wide range of 32 poultry vaccines, some of which have been introduced for the first time as solutions to the ongoing problems of the Indian poultry industry. To emerge as a multiple country operator in vaccines, it is now looking at establishing manufacturing facilities in South Africa and South East Asia. For this it has earmarked Rs 200 crore. At present it is in talks with possible partners and a decision on the overseas operations should happen by next year. The leading poultry vaccine manufacturer is entering manufacturing of human vaccines. Hence came up a new entity called BV Biologicals. The team at BV Biologicals is now working on human vaccines for ailments that afflict a majority of the common populace. Common cold and cough, arthritis and pneumonia are some of the vaccines that will hit the market in the next 18-19 months. This unit at Hinjewadi Biotech Park near Pune is nearing completion. VH Group is investing Rs 60 crore in the first two years and another Rs 120 crore in the following two years. It has also entered into a tie-up with a US-based company for bio-diagnostics and bio generic products. The aim is to bring in certain new molecules for diseases such as cancer. It is also investing in new vaccines and bio therapeutics for child and adult immunization. There are plans to enter the protein drug sector as well. Besides poultry vaccines and medicines, the VH Group produces a range of feed additives, animal health products, poultry feeds and SPF eggs which are a vital ingredient in the manufacture of poultry vaccines of international standards. It was the first Indian company embark on a process of developing the poultry industry on scientific lines. It pioneered the concept of parent franchisee operations, popularized cage farming, and introduced the concept of inactivated vaccines and combination vaccines. ]]> <![CDATA[2. Serum Institute of India]]> https://biospectrumindia.com/news/95/2133/2-serum-institute-of-india.html https://biospectrumindia.com/news/95/2133/2-serum-institute-of-india.html Wed, 15 Jun 2005 13:31:00 +0530 Chairman: Dr CS Poonawalla Socialist Vaccines Intense International competition, especially in the bulk procurements segment, has affected Serum's sales Intense competition in the global marketplace, especially in the bulk procurements segment, is hampering the growth of vaccine makers around the world. And India's leading vaccine exporter too is no exception to this trend. Although the vaccine leader, Serum Institute of India increased its sales to Rs 505 crore in 2004-05, its growth rate is very marginal. Serum Institute of India has recorded sales of Rs 505 crore for the year 2004-05, up from last year's sale of Rs 491 crore, registering a growth of just 2.85 percent. About 85 percent of its sales are from overseas markets. It sells the rest of the vaccines in the domestic market. Serum's major customers are UN agencies that mainly meet the demand in South American countries, Egypt, Africa, Caribbean countries. Serum International Ltd, its marketing arm to sell research based products of Serono, Switzerland has recorded sales of Rs 60 crore in 2004-05 with a negative growth of 6.25 percent against last year's sale of Rs 64 crore. This sluggish growth is mainly due to competition and as most its products are sold to UN agencies at subsidized prices. Since its inception, Serum Institute has placed great reliance on its R&D function. The generous investment on men, machines and materials yielded rich returns. A distinctly separate autonomous body, Serum Institute of India Research Foundation, was instituted with a focus on research in the fields of medical sciences and in natural and applied sciences. The success story of foundation includes the pilot production of measles vaccine on human diploid cells; industrial column chromatography and affinity chromatography for separation of immunoglobulins; monitoring of quality of vaccines in the field. During the year Serum Institute has signed an licensing agreement with London-based Lipoxen Technologies for a major product development program. The agreement involves eight new product candidates, including protein drugs such as GCSF and EPO, anti-cancer drugs and vaccines. The Serum Institute provides the active ingredients and Lipoxen provides enhanced delivery systems. The agreement combines Lipoxen's strengths in intellectual property and innovation in the drug delivery field. Under the agreement, Serum Institute will retain control of marketing in India, Africa, Asia (except Japan) and Latin America, taking advantage of their existing distribution infrastructure. Lipoxen retains control of marketing and sub-licensing in the major market territories and seeks collaboration partners for the marketing of these products in such territories. Serum Institute of India set up Serum International Ltd to market research based products from Serono, world leaders in fertility products. Over the years Serum Institute has eliminated India's dependence on imports for several product lines and emerged as the largest supplier for the government's expanded program of immunization. It is now focusing on other range of products like Hepatitis vaccines, vaccines against HIV, BCG and TB. In December 2004 Serum Institute has launched its unique rabies vaccine called Rabivax at Rs 293, a price within the reach of the majority of Indians. Serum Institute's millennium endeavor is to produce vaccines that would be administered to up to 75 percent of the new-borns of the world. It has an ambitious project coming up at Pune at an investment of Rs 200 crore. This project is expected to be over during the current financial year. It will be for making combination vaccines mainly for pentavalent vaccines (DPT HepB and Hib), which is most sought-after by Global Alliance of Vaccine Initiative, UNICEF, WHO, World Bank. ]]> <![CDATA[1. Biocon]]> https://biospectrumindia.com/news/95/1963/1-biocon.html https://biospectrumindia.com/news/95/1963/1-biocon.html Wed, 15 Jun 2005 12:10:00 +0530 CEO: Kiran Mazumdar-Shaw Unshakeable Leader Biocon has been on a high growth path during the fiscal 2004-05 Biocon's business in biopharmaceuticals and enzymes recorded positive growth. The revenues from its biopharmaceuticals business, which includes statins and immunosuppressants shot up by 28 percent to Rs 557 crore from Rs 435 crore. Maintaining a stronghold on its oldest business of enzymes, the company's total enzyme business grew from Rs 66.50 crore to Rs 89.68 crore, registering a 35 percent growth. During the year Biocon launched Insugen, recombinant human insulin, in the domestic market. This marked Biocon's foray into the protein therapeutics segment. Insugen accounted for a sale of Rs 10.13 crore since its introduction in mid November last year and has reportedly been received well in the country. Biocon posted a total biotech turnover of Rs 646.36 crore during 2004-05, up from 502 crore during the previous year, registering nearly 29 percent growth in its biotech business. The total turnover of the company also showed a similar growth (29.5 percent) clocking a total turnover of Rs 662.16 crore in FY 05, up from Rs 511.17 crore the previous year. The company continues to aggressively invest in discovery led R&D, which it believes is essential for building long term sustainability especially in light of the new WTO-TRIPS era. During the year, Biocon entered into a joint research program with US-based biotech company, Nobex Corporation to develop oral insulin. Both the partner companies have announced a joint R&D program for oral insulin based on Nobex's proprietary conjugated peptide delivery platform. They expect to file an INDA with USFDA by the end of 2005. In addition, Biocon entered into a strategic partnership with Rochester-based biotechnology company Vaccinex Inc. for antibodies. The partnership will enable the companies to develop a pipeline of novel human therapeutic monoclonal antibodies. And given Biocon's strategic foray into immuno-therapy, Vaccinex's human antibody platform provides a strong IP protection for its discovery programs. The 4-arm phase II human clinical trial for its drug TheraCIM (h-R3), a humanised monoclonal antibody, also commenced during the year. The antibody is being evaluated for its efficacy on head and neck cancers. This drug is being developed by Biocon Biopharmaceuticals, Biocon's joint venture with the Cuban Institute CIMAB. This initiative marks a substantial advancement in Biocon's recombinant bio-therapeutic portfolio. These collaborative in-licensed R&D programs are being seen as rapidly developing into very large global opportunities over the next 3-4 years. During the next fiscal Biocon is hopeful of achieving healthy sales growth, despite the pricing pressure on its statins business. "We are planning to maintain current levels of operating margins although the profit for the year ahead may not grow as fast as its sales. This is expected partly due to an increased depreciation charge on its new facilities, which would cater to large US market opportunities for Simvastatin and Pravastatin emerging in 2006. But more importantly, Biocon plans to significantly increase its R& D to support a discovery led research strategy", said Kiran Mazumdar-Shah, CEO, Biocon. During 2004-05 the company's total investment increased to Rs 103.24 crore from Rs 64.44 crore the previous year, registering a mammoth 60 percent jump, reiterating its focus on proprietary R&D. It has filed for 98 patents, including 75 international patents, of which 3 (one Indian and two international) have been granted. Commenting on the future plans of the company, Kiran Mazumdar-Shah, CEO, Biocon, said, "The company's outlook for FY06 is very positive and it expects statins, immuno-suppressants, insulin and branded formulations to deliver significant growth". ]]> <![CDATA[Suppliers]]> https://biospectrumindia.com/news/95/1929/suppliers.html https://biospectrumindia.com/news/95/1929/suppliers.html Mon, 13 Jun 2005 13:13:00 +0530 Indian life science suppliers business reports close to 40 percent growth. Global Suppliers consolidate through M&As. Lab India is No. 1 life sciences supplier. Biosuppliers to carry diagnostics products. Four companies surpass Rs 100 crore barrier. During the last two years, the Indian pharma and biotech companies have focused on increasing their R&D spend and expanding their manufacturing capacities. These developments have spurred the life suppliers industry in a big way. In fact, India has been one of the fastest growing regions for several leading global suppliers. Waters, for example, has reported in its annual report 2004 that its business growth in Asia exceeded other regions with sales growth rates in China and India more than doubling the company's overall rate. Its total revenues from India stood at $33 million. For Pall Life Sciences, USA, the sales would grow at the rate of 19 percent in the Asian region. The LSCA business of Agilent Technologies in India is now the fourth-largest country of business in Asia, and one of the fastest growing for Agilent. The total business of the suppliers to the Indian life sciences industry in 2004-05 stood at Rs 1,230 crore, up by 39.77 percent compared to the previous year's figure of Rs 880 crore. The Top 20 suppliers accounted for 87 percent of the total life science suppliers business. The Top Five players alone accounted for 43.6 percent of the total life sciences suppliers' business. Interestingly, for the first time, the Rs 100 crore mark has been surpassed. Importantly, four companies-Lab India, Waters India, Spinco Biotech, and Becton Dickinson India-crossed the Rs 100 crore mark. The market leader in 2004-05 was Lab India with total sales of Rs 119 crore to the life sciences sector. Waters India, among the Top 20 suppliers, registered the highest growth at 77.34 percent to rake in revenues of Rs 113.50 crore from sales to the Indian life sciences companies and institutions. With the life sciences suppliers supplying over 800 products, from consumables like test tubes, reagents, and pipettes to high-end equipment like bioreactors, fermentors, HPLC and LCMS, it is difficult to even make a guess on the market size of each of the products. However, considering just the market size of the analytical instruments it would be around Rs 435 crore growing at the rate of 25 percent. In the HPLC segment, the race is clearly between Spinco Biotech, distributors for Shimadzu HPLC, Waters, PerkinElmer and Agilent. Labindia is exclusive partner in India for Applied Biosystems. BD Biosciences provides integrated systems, products and services for a variety of applications in life sciences. Interestingly, among the Top Five players, three-Waters, Becton Dickinson, and Thermo Electron-are major global vendors, with direct operations in India. The Two Indian distributors in the list, Lab India and Spinco Biotech, carry a range of products from various major suppliers. The trend has been to consolidate, be it the distributor or the principal vendor. For example, Lab India and Spinco Biotech excel in the market place not only because of their strategic alliances strategy, but also due to their focused solutions approach and nation-wide sales and support network. On the other hand, companies like Thermo Electron Corp. have looked at setting up new divisions. The Board of Directors of Alfa Laval (India) Ltd has given its approval to Alfa Laval Holding AB, Sweden, to establish a wholly owned subsidiary in India. Similarly, Cambrex too has firmed up its position in India by combining its different divisions under one umbrella, Cambrex India. While the major global suppliers are taking the route of in-licensing agreement and exclusive marketing agreements with the local dealers to market their products, local companies are taking the strategic alliances route to increase their product portfolio and offer better services. For example Korea-based SPL Labware (SPL), a bioscience labware manufacturer, has launched its operations in India through Hysel India Pvt Ltd. Similarly, Swedish Biotech major Mabtesh will supply its ELISpot reagents in India through Jain Biologicals. Corning Life Sciences and Delhi-based Axygen Scientific have joined hands to deliver the entire range of life science products in the Indian market. Wealtec Corp. of US and Medispec Instruments India have tied up to offer Dolphin series of gel documentations systems in the country. Phase Technology, Canada and Accustandard Inc., USA, have Skytech Systems as their authorized distributors in India. Clearly, the number of alliances has been on the rise. Further, with the suppliers segment finding favor with the government on customs duty reduction, the market is expected to grow further. The Union Budget 2005 has announced reduction of custom duty to five percent on nine specified equipment. These R&D equipment are used extensively in the pharma and biotech sectors. Global M&As continue unabated India cannot escape from the impact of global mergers and acquisitions in this sector as there are over 25 multinational suppliers operating directly in India and several others through indirect presence. Some of these global majors acquired or combined to strengthen their product portfolio and to meet the needs of the customers in a better way and to reach out to different customers. General Electric (GE) acquired Amersham PLC in 2003. And since then the M&A phenomenon has caught on in a big way. The combined entity is over $14 billion in revenues and is expected to generate $16 billion in 2005. The merger was in belief that the technology and service driven businesses will change the face of healthcare. The trend is towards adding the diagnostics portfolio. Similarly, Bio-Rad Laboratories Inc. signed a binding agreement to acquire MJ GeneWork Inc., and its subsidiaries. It has also made a proposal to BioSource International, to acquire all of its outstanding shares for $8.50 per share in cash. In recent years Bio-Rad has integrated several acquisitions in the areas of blood virus, food safety, process chromatography and gene expression. KMS International LLC acquired PURON AG, a Germany-based manufacturer of submerged hollow-fiber membrane modules for wastewater treatment. KMS International is a subsidiary of Koch Membrane Systems Inc. based in Wilmington, Massachusetts. As a wholly owned subsidiary of KMS International, PURON will continue to be based in Aachen, Germany. Agilent Technologies Inc. acquired Computational Biology Corp., a biotech company in ChIP-on-chip, a microarray-based technique for understanding gene regulation in disease. This acquisition is strategically important to the expansion of Agilent's microarray platform into new array-based genomics applications. Pall Corp. acquired Euroflow (UK), a leading manufacturer of pilot and production scale chromatography columns for the biotechnology industry. Pall held exclusive global marketing and distribution rights to Euroflow chromatography columns and associated technologies since 2002. It earlier acquired BioSepra Process Division of Ciphergen Biosystems Inc, which is strong in chromatography sorbents used in protein purification. These acquisitions allow Pall to offer integrated solutions. In another development, Thermo Electron Corp. entered a definitive agreement to acquire the Kendro Laboratory Products division of SPX Corp. Kendro is a major supplier of laboratory equipment for sample preparation, processing and storage used primarily in life sciences and drug discovery laboratories and in clinical laboratories. PerkinElmer acquired Elcos AG, an European designer and manufacturer of custom LED (light emitting diode) solutions for biomedical and industrial applications. Elcos delivers high performance LED solutions with a majority of its revenues coming in from biomedical instrumentation. This is a partial list. Though these developments will not have a major effect in the next one year in India, the companies here are gearing to introduce the new products. The market is all set to witness entry of new products. For example, Agilent Technologies recently announced plans to introduce its DNA microarray-based genomics solutions in India. Agilent currently sells technologies for the chemical, environmental and pharmaceutical manufacturing markets in India and expects to expand its presence into other areas like medical research, drug discovery and agro-biotech. Undoubtedly, companies would consolidate their businesses with complementary technologies. ]]> <![CDATA[BioServices on Fast Track]]> https://biospectrumindia.com/news/95/1122/bioservices-on-fast-track.html https://biospectrumindia.com/news/95/1122/bioservices-on-fast-track.html Mon, 13 Jun 2005 13:12:00 +0530 Bioservices segment records 54 percent growth. Lotus Lab acquired in Rs 120 crore deal. Sygene is the largest CRO with Rs 66 crore in revenues. Bill to regulate clinical trials to be introduced. The most talked about biotech today is the bioservices sector. India is being touted as one of the most important destinations for clinical trials, contract research, and contract manufacturing. Developments in the passing year certainly put India on high radar. One of the most important developments was the acquisition of Lotus Labs by Actavis Group, a European generic drug manufacturer in $25.52 million (Rs 120 crore) deal, in February. This was a landmark development as it was the largest and the first ever such deal in the Indian CRO business. This deal is being seen as the forerunner to decide valuations in the CRO business. Lotus Labs, which has conducted over 500 biostudies, recorded close to 120 percent growth in its revenues. Its business in 2004-05 was Rs 27.55 crore. The valuation is almost four-and-a-half times the total size of its revenues. With this, Actavis has expanded its presence in the Indian pharmaceutical market. Another important development in the year has been Quintiles Transnational's opening of a data management center in Bangalore. It currently has a staff strength of 187 in data management and is moving all its global data management activities to this center. Today several other leading players like GSK, Pfizer and Wyeth have their clinical data management centers in India. These trends clearly demonstrate India as an important destination for outsourcing business. The total bioservices sector in India witnessed 54.54 percent growth in revenues over that in 2003-04. The total bioservices business was Rs 425 crore in FY 2004-05. Biocon subsidiary, Sygene was the leading services company with revenues from its custom and clinical research growing by 71.6 percent to Rs 66.6 crore from Rs 39 crore in 2003-04. Quintiles was the next big player with total revenues of Rs 64.55 crore. Hyderabad-based Vimta Labs was the third largest company with a total business of Rs 52.19 crore. Vimta Labs is followed by Lotus Labs and Lambda Therapeutic. Lambda registered 56.25 percent growth in 2004-05 and the ended the year at Rs 25 crore. Another Indian company to watch out for is SIRO Clinpharm, a full service Contract Clinical Research Organization conducting clinical trials in various therapeutic areas. SIRO's revenue figures were unavailable for the year. Nonetheless, the company increased its head count from 62 in 2003-04 to 152 in 2004-05 with 12 PhDs and 91 postgraduates. The company is estimated to have revenues in excess of Rs 60 crore. SIRO, which offers services from clinical development to management of clinical project, has been working with several clients from Europe, Japan and the US. It has entered into marketing alliance with Covance Inc. and Spacelabs Medical Data. Pfizer's services revenues grew to Rs 20.92 crore of business; Synchron Research Services business doubled to Rs 10 crore; and Wellquest's services revenues was up by 50 percent to Rs 10 crore. The government wants to give a fillip to this sector by introducing a bill to regulate the clinical trials environment keeping in mind ethical issues remove hurdles for scientists conducting quality research. n Top 5 BioService Players Rank Company Revenues (Rs Crore) 2003-04 Revenues (Rs Crore) 2004-05 % Growth in 2004-05 % Share in  2004-05 1 Syngene 38.48 66.06 71.67 15.54 2 Quintiles India 62.55 64.55 3.2 15.18 3 Vimta Labs 35.11 52.19 48.65 12.28 4 Lotus Labs 12.54 27.55 119.7 6.48 5 Lambda Therapeuitic 16 25 56.25 5.88 6 Others 110.4 189.75 71.88 44.64 Total BioServices 275.08   425.1   54.54   100   ]]> <![CDATA[Publisher's Note]]> https://biospectrumindia.com/news/95/5694/publishers-note.html https://biospectrumindia.com/news/95/5694/publishers-note.html Mon, 13 Jun 2005 13:10:00 +0530 Dear Readers, I would like to thank all investors, many of whom are subscribers and readers of CyberMedia's magazines, for their hearty support to our IPO. Your support has vindicated our efforts of the last 22 years in the various industries that we have served. In 1982, a small group of six people, with Rs 1.6 lakhs embarked on a journey in a fledging industry called Information Technology. It was our belief that this industry could become a precursor to the future of India, that led us to launch Dataquest which has in these twenty-two years watched the growth of industry from the ring side-reporting, analyzing, supporting, and critiquing the industry. The industry grew and so did we, to achieve strong growth for our shareholders. Ten thousand rupees invested in CyberMedia in 1982 have grown today to Rs 2 crore at the IPO price. And, this has happened because of the mutual bonds that have been established between CyberMedia, its readers, its advertisers, and the policy makers. CyberMedia's growth has come because of a strong set of values: Innovation, Integrity, Excellence, Influence, and Caring Meritocracy. Innovation forms the DNA of CyberMedia. We have a number of firsts to our credit, which has resulted in a strong presence in the Information Technology, Communications, Biotechnology, and Consumer Electronics domains. We believe in Excellence, in all the products and services we offer. This has resulted in 12 lakh readers, a 7-lakh online community, and a 60 percent market share. We have had a positive Influence in the domains we have operated in. CyberMedia's products are recognised for their forthright and balanced views, which have shaped policies, markets, and usage in the various industries. We have achieved all this by inculcating the principle of Integrity in whatever we do; and that is why we have a loyal customer base. Internally, we have communicated the principle of Caring Meritocracy for our employees, whereby a mix of task-oriented and relationship-oriented styles has resulted in a steady band of people who have endeared you with their writing in the past. This IPO is a step towards our future endeavors, in which we would like to continue to provide strong returns to our investors as well as stick to the principles that have resulted in our success so far. We are now embarking on the path of globalization and want to take Indian brands to the global markets. Towards this, we have launched Global Outsourcing, which will address the global markets for offshoring. This magazine will be the first Indian media brand to be distributed in global markets, addressing that audience and not merely the Indian diaspora. We are also taking the brand BioSpectrum global, by launching a Southeast Asian edition. Our global strategy would also see CyberMedia playing a strong role in the media services medium by offering backend services in content to international companies. The last two decades have indeed been a very satisfying journey. We hope that the next two decades would also be equally exciting and will establish CyberMedia as an international media player in the knowledge industry with its quality products and services. I once again thank all the investors for supporting CyberMedia's IPO. I look forward to continued value creation in the future. Pradeep Gupta chairman and managing director CyberMedia (India) Limited ]]> <![CDATA[News Snipets June 2005]]> https://biospectrumindia.com/news/95/2766/news-snipets-june-2005.html https://biospectrumindia.com/news/95/2766/news-snipets-june-2005.html Mon, 13 Jun 2005 13:08:00 +0530 Cherian Philip to head US ABLE chapter The Association of Biotechnology Led Enterprises (ABLE) is opening its US Chapter with Cherian Philip, chairman and managing director of Sartorius India Pvt Ltd, Bangalore as honorary director. This was decided at its executive council meeting held on April 25, 2005. Cherian Philip has held various positions in the group and has built Sartorius from a single person operation to an organization with over 300 employees currently. ABLE's participation in the forthcoming BIO 2005 in Philadelphia from June 19-21, 2005 provides a timely launch for the US Chapter and will be an effective platform to promote the Indian biotech industry in the US. Dr Kiran Mazumdar Shaw, president, ABLE said, "The launch of ABLE's US chapter is a significant milestone as India's biotechnology success needs to be showcased in the United States. India provides a tremendous opportunity for bio-partnering and several biotech companies in India have already forged alliances with companies in the United States. We are certain that under the leadership of Cherian Philip, the ABLE US chapter will be a tremendous success."   GSK launches 'Koi Hai' program GlaxoSmithKline (GSK) Vaccines has launched 'Koi Hai', an education program on Hepatitis A. The program is aimed at creating awareness and educating the public on the disease. Koi Hai program entails social interventions at the workplace, in schools and in clinics that reach out to the various segments of audiences. A key project is the workplace intervention program that has been initiated in people intensive sectors for e.g. public sector units (PSUs), BPOs, IT companies and paramilitary forces. A large-scale mass media campaign would be prominent across the main centers in India with a film issued in public interest. This film will be aired on various television channels. Dr Sanjoy K Datta, medical director, GSK Vaccines, said, "Hepatitis A is a highly infectious disease that can be prevented. Our research has proven that awareness levels are quite low and that people are unaware of the types of hepatitis infections, its symptoms, sources of infection and prevention methods. This emphasizes the need for an educational campaign on hepatitis A that would equip people to protect themselves against the possible threat of the disease." VH group to launch vaccines for cold, arthritis by 2007 Pune-based Venkateshwara Hatcheries (VH) group leading poultry vaccine manufacturer, is working on three major vaccines for ailments that afflict a majority of the common populace and expected to be released in 2007. Common cold and cough, arthritis and pneumonia are some of the vaccines that will hit the market in the next 18-19 months. "We are in the final stages of the development of the vaccines and had applied for an Indian patent. We have already obtained the US patent for these vaccines and are presently working on the mode of dispensing the vaccines oral or injections, " said OP Singh, CEO, Venkateshwara Hatcheries Pvt Ltd. The objective is to provide affordable healthcare products for the masses. Around 40 per cent of these vaccines are meant for the export market, informed Singh. He further informed that BV Biologicals - the new entity of the VH group set up at the Hinjewadi Biotech Park was nearing completion. Singh said that the company is investing Rs 60 crore in the first two years and another Rs 120 crore in the following two years. The company entered into a tie-up with a US-based company for biodiagnostics and biogeneric products. The aim is to bring in certain new molecules for diseases such as cancer. The company is also investing in new vaccines and biotherapeutics for child and adult immunization. There are plans to enter the protein drug sector as well. Panacea Biotec posts net Rs 7.36 crore in Q4 Panacea Biotec has posted a net profit of Rs 7.36 crore for the fourth quarter ended March 31, 2005, against Rs 0.44 crore in the same quarter the previous year. Operating profit has increased by 42 per cent to touch Rs 14.93 crore (Rs 10.52 crore). Panacea Biotec has achieved record turnover of Rs 335.76 crore (Rs 272.15 crore) for the 2004-05 fiscal, a growth of 23 per cent, stated a company release. Operating profit during the period was Rs 72.13 crore (Rs 42.43 crore). The company recorded a net profit of Rs 30.06 crore (Rs 16.45 crore), up by 83 per cent. Strides Arcolab to acquire 60 percent stake in Biopharma Strides Arcolab Ltd, a Bangalore-based pharma company, announced that its Board of Directors approved the proposal for acquisition of up to 60 percent stake in Biopharma, a Venezuelean pharmaceutical and marketing company. The proposed acquisition would be at a cost not exceeding $1.00 million and would be subject to due diligence. Post due diligence, the investment would be made by Strides through Strides Latina SA, Uruguay the investment vehicle of the company for its Latin American operations. CCMB to have LACONES by July A new Laboratory for the Conservation of Endangered Animal Species (LACONES) will be opened in July at the Centre for Cellular and Molecular Biology (CCMB), Hyderabad. The Laboratory will help in the preservation of endangered species including the tiger. Announcing this, Kapil Sibal, minister for science and technology and ocean development said that preserving the tiger is actually persevering the human species. He said that two different methods would be adopted for preserving the genetic diversity of the tiger population in the country. The first plan of action involves collection of the tigers' scat samples for DNA finger printing, which will give an accurate picture of the number of tigers in a forest area. If it is found that there is lack of genetic diversity, a second method involving stunning the tiger and collection of sperms through electro ejaculation will be adopted. The sperms having maximum virility will be frozen and will be used for genetic diversity through artificial insemination. In this process we do not need cloning, Sibal said. By July the process of collecting the scat samples will be started by training the Forest Department workers. It is a joint project by the Council for Scientific and Industrial Research (CSIR) and the Department of Biotechnology. By the end of the year, we shall have the complete picture of the tigers, said Sibal. Nuziveedu launches Bt cotton strains Nuziveedu Seeds Ltd, a seeds manufacturer, has launched Bt versions of its cotton hybrid varieties - Bunny and Mallika. The Genetic Engineering Approval Committee (GEAC) had cleared Bunny Bt and Mallika for commercial release in May. Nuziveedu Seeds had entered into a pact with Mahyco-Monsanto for using Bt technology in the new varieties. The GEAC had earlier rejected extension for three Bt cotton varieties of Mahyco-Monsanto in Andhra Pradesh. The GEAC approval for Nuziveedu Seeds is for the commercial release of Bt varieties in Maharashtra, Gujarat, Madhya Pradesh, Karnataka, Tamil Nadu and Andhra Pradesh. "We have prepared about five lakh packets (each containing 450 gm) of Bt hybrid seed for cultivation in the kharif season. Of these, 1.2-1.5 lakh packets will be sold in Andhra Pradesh. Each packet contains 120 gm of hybrid seed," said M Prabhakar Rao, managing director, Nuziveedu Seeds Ltd. Mahyco's Bt versions get GEAC nod The Genetic Engineering Approval Committee (GEAC) has given its approval to Maharashtra Hybrid Seeds Company (Mahyco) to market its three varieties of Bt cotton hybrids - MECH-12Bt, MECH-162Bt and MECH 184Bt - containing Cry 1 Ac Gene for the central zone (consisting of Madhya Pradesh, Gujarat and Maharashtra) for another two years. However, it decided to not to renew the permission for Mahyco to market Bt cottonseeds in Andhra Pradesh. For the other southern states of Tamil Nadu and Karnataka, the GEAC has approved two of the Bt cotton hybrids (MECH-162Bt and MECH 184Bt). However, it has barred commercialization of MECH 12 Bt for Tamil Nadu and Karnataka as well. The GEAC had allowed commercialization of Bt cotton hybrids in the central and south zones for three seasons beginning 2002. For the last two months, GEAC had deferred its decision on renewal of Bt cotton following protests by civil society groups including Greenpeace and Gene Campaign. It had, however, permitted commercial marketing of the Bt cottonseeds in the north zone. The GEAC has also permitted commercialization of Rasi's two hybrids of Bt cotton for certain states. They include RCH 144 Bt for central zone that include Maharashtra, Gujarat and Madhya Pradesh and RCH 20 Bt for southern zone that include Andhra Pradesh, Karnataka and Tamil Nadu. ]]> <![CDATA[Foundation laid for Kinfra Biotech Park at Kalamassery]]> https://biospectrumindia.com/news/95/1604/foundation-laid-for-kinfra-biotech-park-at-kalamassery.html https://biospectrumindia.com/news/95/1604/foundation-laid-for-kinfra-biotech-park-at-kalamassery.html Mon, 13 Jun 2005 13:07:00 +0530 Oommen Chandy, chief minister of Kerala has laid the foundation for the Kinfra Biotech Park at Kalamassery near Kochi. The park set up by Kinfra would be a combination of a technology incubation center providing modules for R&D in biotechnology, a pilot plant, and a business enterprise zone comprising developed plots to be utilized to set up industrial units. Speaking after laying the foundation stone, the chief minister said that Kerala had become a favorable destination for investment after the Global Investors' Meet."However, this atmosphere should fully be exploited by attracting more and more investors to the state. The development of the agriculture sector acquires momentum in the era of globalization and liberalization. For this, biotechnology has to play a vital role for its development. Therefore, the government has decided to give equal preference to biotechnology and IT," he said. ]]> <![CDATA[Avesthagen and NestlÃ© partner for research collaboration]]> https://biospectrumindia.com/news/95/5767/avesthagen-and-nestl-partner-for-research-collaboration.html https://biospectrumindia.com/news/95/5767/avesthagen-and-nestl-partner-for-research-collaboration.html Mon, 13 Jun 2005 13:02:00 +0530 NestlÃ© Nutrition, a unit of NestlÃ© SA the world's largest food and beverage company, and Bangalore-based Avesthagen have agreed on a research and development program. The program aims to validate the role of nutritional bioactives in foods through research. The collaboration brings together a world-leader in Food (Nestle) with a technology development company (Avesthagen) to validate using new technologies and to develop a delivery mechanism for the immense body of knowledge that exists within traditional Indian medicine. The outcome will be a new line of food products that are exclusively developed to promote health, backed by the quality and assurance of Nestle. Dr Villoo Morawala-Patell, founder & CEO, Avesthagen said, "We are very excited about our collaboration with Nestle and look forward to a mutually productive relationship between our two companies. The development program signifies Nestle's confidence in our research capabilities and the validation of our Food for Medicine Research efforts at Avesthagen." ]]> <![CDATA[SMi to provide link for Indian firms with Western Europe]]> https://biospectrumindia.com/news/95/1884/smi-to-provide-link-for-indian-firms-with-western-europe.html https://biospectrumindia.com/news/95/1884/smi-to-provide-link-for-indian-firms-with-western-europe.html Mon, 13 Jun 2005 12:57:00 +0530 The UK-based Smi, Strategic Marketing Information, will provide a link for Indian organizations that are looking to create partnerships within Western Europe for communications and marketing expertise. It is also keen to initiate agreements for SMi Event Media, to provide CD-ROMs, DVD-ROMs, web-based applications and, where relevant, sponsorship sales for clients within the Indian bio market to help disseminate information in different areas. SMi currently operates with approximately seventy staff specialising in conference production and information management. The SMi Group has a strong profile that pertains to high quality programs and publications. ]]> <![CDATA[Matrix, Strides Arcolab to merge to form No.7 pharma firm]]> https://biospectrumindia.com/news/95/3760/matrix-strides-arcolab-to-merge-to-form-no-7-pharma-firm.html https://biospectrumindia.com/news/95/3760/matrix-strides-arcolab-to-merge-to-form-no-7-pharma-firm.html Mon, 13 Jun 2005 12:56:00 +0530 The Board of Directors of Strides Arcolab and Matrix Labs at their board meetings in Delhi and Hyderabad respectively, have in principle agreed to a plan of merger of the two companies. The proposed merger is subject to a valuation exercise to be conducted by an independent firm of Chartered Accountants, while the two companies will conduct due diligence of each others business. The Boards of the two companies expect to meet within six to eight weeks to finalize the terms of the plan. The merger will be effective April 1, 2005 and is subject to shareholders' approval of both companies and other regulatory approvals. The combined proforma sales for the 12-month period to March 2005 were over Rs 1000 crore and net profits in excess of Rs 170 crore. The combined entity will be called Matrix Strides Limited and will emerge amongst India's leading integrated pharmaceutical companies. In a joint statement issued, after their respective Board Meetings, chairman and CEO of Matrix, N Prasad and Arun Kumar, chairman and Group CEO of Strides Arcolab stated: "The coming together of two leading first generation pharmaceutical companies with similar philosophies and vision will create a significant generic company based out of India with worldwide operations. The merger of the two companies will compliment each others strengths and will emerge as a leader in the global generic space, leveraging Indian innovation and a strong global partnering philosophy." ]]> <![CDATA[Roche ropes in Wasim Akram as its brand ambassador]]> https://biospectrumindia.com/news/95/1032/roche-ropes-in-wasim-akram-as-its-brand-ambassador.html https://biospectrumindia.com/news/95/1032/roche-ropes-in-wasim-akram-as-its-brand-ambassador.html Mon, 13 Jun 2005 12:49:00 +0530 Roche Diagnostics India Pvt Ltd, a leading player in the area of diagnostic products, launched an advertising campaign for its flagship brand Accu-Chek with cricketer Wasim Akram as the brand ambassador. The campaign is an extension of 'Accu-Chek Inspiration Series' started in October 2004 with Wasim Akram. 'Accu-Chek Inspiration Series' aims to create awareness through road shows across the country, on diabetes and its management through self-monitoring. Accu-Chek is a fast, accurate and reliable Blood Glucose Monitoring System specifically designed to help people with diabetes to monitor their blood glucose levels themselves. The new campaign by Roche Diagnostics exhorts consumers on Accu-Chek's philosophy of 'Live Life- The Way You Want,' - a conviction, that one can lead a normal life despite being a diabetic. Sanjeev Johar, managing director, Roche Diagnostics India Pvt Ltd said, "Consumers today live life in the fast lane and are increasingly adopting 'do-it-yourself' products, which provide both convenience as well as confidence. People have also started to realize that incurable diseases can be managed with regular monitoring and control. Through this campaign, we want to emphasize the importance of timely self-monitoring and hence lead a healthy lifestyle. Wasim Akram personifies the spirit of the Accu-Chek brand and we are hopeful of a long and fruitful innings with this association." ]]> <![CDATA[Regulatory issues in biotech industry need more clarity: FICCI]]> https://biospectrumindia.com/news/95/2480/regulatory-issues-in-biotech-industry-need-more-clarity-ficci.html https://biospectrumindia.com/news/95/2480/regulatory-issues-in-biotech-industry-need-more-clarity-ficci.html Mon, 13 Jun 2005 12:42:00 +0530 Describing the Draft National Biotechnology Strategy report as pragmatic, the Federation of Indian Chambers of Commerce and Industry (FICCI) said foreign direct investment (FDI) and regulatory issues in clinical trial processes in the biotech industry need more clarity. Considering the capital-intensive needs of the biotech industry, FICCI said, the proposed 'Small Business Innovation Research Initiative' to provide financial support of up to Rs 50 lakh for small and medium-size entrepreneurs does not seem adequate for small-time players. However, it felt that 100 percent FDI in the form of equity in the biotech sector needed a little more transparency and the procedure for regulatory approvals continued to be fraught with bottlenecks. Hence, in order to attract more FDI, FICCI felt that the government had to remove the hurdles, implement smoother regulatory mechanisms and provide adequate infrastructural facilities. FICCI pointed out that the policy rightly put the spotlight on the human resource problem plaguing the industry. The proposed introduction of public-private partnerships in PhD programmes through creation of 'Bio-edu-grid', a network of universities and industries will facilitate pooling of resources. However, there was no single body or council to standardize the biotech curricula and review the trends in the industry, it added. Overall, FICCI noted that the strategy report had fulfilled the long-standing demand for a unified regulatory system and the sector had got the status of 'priority sector' for the purpose of getting funds from banks for long gestation projects. ]]> <![CDATA[Human Biologicals launches drug for rabies]]> https://biospectrumindia.com/news/95/1150/human-biologicals-launches-drug-for-rabies.html https://biospectrumindia.com/news/95/1150/human-biologicals-launches-drug-for-rabies.html Mon, 13 Jun 2005 12:38:00 +0530 Human Biologicals Institute (HBI), a division of the Indian Immunologicals Ltd and fully owned subsidiary of the National Dairy Development Board (NDDB), has announced the national launch of Equine Rabies Immunoglobulin (ERIG), a drug for the animal bite management. "With the launch of ERIG, the institute would be addressing all the three areas of category-III animal bite management that includes wound management, administration of rabies immunoglobulin and administration of anti-rabies vaccine," said Dinar A Kumar, general manager, HBI. He added, "At present, two types of rabies immunoglobulin were available the world over, human (HRIG) or equine (ERIG) origin. As against the imported drug price of Rs 450 per dose, HBI plans to sell the product at Rs 350 per dose. The institute expects to garner a significant share in the Rs 60-crore plus Indian RIG market." The Hyderabad-based VINS Bio Products Pvt Ltd has developed the drug ERIG. HBI has entered into an alliance with Wins Bio for marketing the product. HBI would be marketing ERIG under the brand name 'AbhayRIG' through its 2,000-odd 'Abhay' clinics spread across the country. ]]> <![CDATA[Indian Bioinformatics tools going global]]> https://biospectrumindia.com/news/95/2724/indian-bioinformatics-tools-going-global.html https://biospectrumindia.com/news/95/2724/indian-bioinformatics-tools-going-global.html Mon, 13 Jun 2005 12:32:00 +0530 Indian Bioinformatics market is about Rs 100 crore Biotech companies are setting up bioinformatics cells Biosuppliers are entering the bioinformatics space Government initiatives to support the segment The Indian bioinformatics market closed the year at about Rs 100 crore, of which about 40 percent is from the local market and rest from exports. This includes Rs 25 crore from sales of real bioinformatics products/ tools. Last year it was pegged at about Rs 70 crore. Considering the opportunity, it is expected to grow to $120 million (Rs 530 crores) by 2006 and likely to take a major pie in the global bioinformatics sector in next few years. India's entry into the product patent regime in 2005 has really boosted the bioinformatics sector in 2004-05. Many leading Indian pharmaceutical companies are investing on R&D to take an early lead in this new patent regime. At present there are about 45 companies in this space mainly based in southern cities like Bangalore, the IT capital of India, Chennai and Hyderabad. About 20 percent of them are based in Delhi and a few in Pune, the knowledge center. Of these about 35 companies are actually involved in developing bioinformatics tools and products while the rest are into marketing of the tools. In addition to Indian companies, multinationals like Accelrys (a subsidiary of Pharmacopeia), Tripos are also in this space with direct presence in India. The big IT companies like Infosys, Cognizant Technologies are offering bioinformatics services while IBM, Sun Micro Systems, Intel are providing the hardwares. With the changing scenario in the global market, many small and medium companies have either closed or joined hands with leading companies in the same space or with biosuppliers who are into marketing of equipments/ products to biopharmaceutical and biotechnology companies. One can expect the same trend in India also as companies like Agilent, Thermo Electron, Bio-Rad are entering this space. Consolidation will become the new mantra in the years to come. Companies like Strand Genomics, SciNova Technologies, Mascon Life Sciences, Ocimum Biosolutions, Life Sciences, Helix Genomics have about 5-8 products in their kitty. Tata Consultancy Services launched its much-awaited Biosuite product last year. These companies offer forward integration of IT systems in drug development and also help in implementing clinical trial programs at lower cost with shorter time lines. By exhibiting cost saving skills, Indian firms are getting product enquiries and business related to data mining, scientific visualization, information storage, retrieval of special structure data and simulation of long DNA sequences. Indian players have to leverage the lower costs of infrastructure and human resources. The cost of setting up and running a bioinformatics company in India is a fraction of the cost in the US. Indian companies will have to target pharmaceutical and biotechnology companies, as well as agribiotech and industrial biotech companies. Some Indian bioinformatics enterprises have already been acknowledged in the US and European markets for their cost saving potential. These companies have demonstrated cost saving to the extent of 30-40 percent in drug development process. With this, many Indian enterprises are getting orders to jointly collaborate with major pharmaceutical and biotech companies. Already some companies in India have made forays locally and into the global market. In June 2004 Strand Genomics from Bangalore licensed its microarray gene expression analysis software to antibody company Abgenix in Fremont, California. And Lion Bioscience Research in Cambridge, Massachusetts, licensed NetPro, a proprietary protein interaction database of Molecular Connections, in Bangalore, to conduct drug target identification research exclusively for Bayer, Leverkusen, Germany. Similarly Ocimum Biosolutions, which has acquired Microarrays from MWG, Germany called Ocichips and the entire array of microarray products, had sales of Rs 7 crore last year and is now targeting at reaching Rs 30 crore in 2005-06. It has entered into a marketing alliance with UBI, Scimax, Science partners to market its products in the global market. It is also looking at increasing its head count to 160 from 97 in 2004. On the other hand Cytogenomics, an early-stage bioinformatics company based in St Louis, Missouri , with a development center in Bangalore and achieved revenue of over Rs 5 crore last year, is now looking at expanding its area of business by moving up the value chain. Currently, it is in the market with SilicoCyte, a microarray informatics product and also caters to various bioinformatics product and services. It is targeting to grow the revenue by over 300 percent in the next five years. Even the leading biopharmaceutical companies like Dr Reddy's Labs and Wockhardt have set up bioinformatics cells to undertake research in this space, only to meet their in-house research activities. Wockhardt is working on metabolic engineering. Instead of coming as hindrance to the real bioinformatics companies these cells/units at the biopharmaceutical companies will help them in marketing their tools. To promote the rapidly emerging field of bioinformatics in the country, many professional have joined hands and set up a non-profit society called Bioinformatics Society of India. This three-year-old society is basically aimed at bridging the gap between the educational and corporate sector. It will strive towards catering the needs of aspiring learners of this field by creating a genuine awareness and to attain perfection to set a benchmark in bioinformatics. In addition to this, the government is also making efforts to support the segment by setting up BioIT Park. The Department of Biotechnology has been working with other departments to set up this park, which is expected to position India in the global hub of Bioinformatics. The Department of Biotechnology in its National Biotech Development Strategy has also pointed out some strategic action plans in the following areas - human resource development, infrastructure development, testing of public domain resources, inter agency coordination, strengthening of DICs and sub DICs and Bio IT parks and promotion of bioinformatics industries. These initiatives will support the segment to grow vertically and to take a major pie in the global bioinformatics sector in the next few years. ]]> <![CDATA[BioIndustrial makes silent progress]]> https://biospectrumindia.com/news/95/1188/bioindustrial-makes-silent-progress.html https://biospectrumindia.com/news/95/1188/bioindustrial-makes-silent-progress.html Mon, 13 Jun 2005 12:29:00 +0530 Enzymes market records 34.5 percent growth. Indian companies like Advanced and Span to set up new production facilities. Biocon is the top enzymes company. Global vendors like Genencor and CHR-Hansen come direct. The BioIndustrial sector, which predominantly comprises the enzymes companies, is estimated to be Rs 320 crore in 2004-05. The total industry registered 34.45 percent growth in 2004-05. There are about 17-20 players in India and the market leader in the segment during 2004-05 was Biocon, with total sales of Rs 89.68 crore. Its enzymes business registered 34.82 percent growth. Novozymes is the other major player in the segment and the company is estimated to have done a total business of Rs 69 crore in 2004-05. Advanced Biochemicals, which has a strong R&D, manufacturing, and formulation knowledge of over 16 years, has reported its enzymes business grow by 31.8 percent. The company's total enzymes business was Rs 39.55 crore. Growing consumption of enzymes in the existing application areas, use of enzymes in the new industrial processes, strict enforcement of environment laws and cost savings were some of key drivers for the growth of this sector in India. While, worldwide, the detergent industry is a major user of enzymes, India is a peculiar market. In India, this industry is still using the hand mixing process. However, in the next few years the industry is expected to use enzymes in a big way. Similarly, the food processing industry too is expected to substantially increase the consumption of enzymes. The government is encouraging establishment of wine parks for processing of grapes for value addition. Beer and brew industry finds a large potential for use of enzymes for improving the quality, higher yields and process efficiency. The textile industry is another sector that is consuming large quantities of enzymes for desizing, stone wash of denims, bioscouring, biopolishing of synthetic/natural yarns, raw silk and wool and for fabric. The break up of industry wise demand was difficult to capture. Nonetheless, the popular perception is that the pharma sector accounts for 50 percent of the total sales, followed by detergent manufacture (20 percent), textile processing (20 percent), food and feed (5 percent) and leather and paper (5 percent). Indian companies produce various enzymes like amylases, proteases, cellulases, xylanases, glucoamylases, pectinases, papains, bromelain, catalases and several other eco-friendly biological products. The product range and services are growing rapidly as the use of enzymes is gaining widespread acceptance. Companies are looking at producing different types of industrial enzymes using all the natural methods of production, from plants and vegetable origin, fermentation-both with solid state and submerge culture techniques. Leading global players like Novozyme, Genencor International, Enzyme Development Corp., Dyadic International and Quest International are present here directly or indirectly. Genencor, a global leader in the enzyme market and having presence in India since 1996, is planning to enter the Indian market on its own. It has taken a few people on board. Last year Danish company CHR-Hansen set its shop here to market its products used in the food processing industry. Market Share of Companies Company 2004-03Revenues Rs Crore) % Share Biocon 89.68 28.03 Novozymes 69 21.56 Advanced Biochemicals 39.55 12.36 Rossari Biotech 33 10.31 Maps India 22 6.88 Others 66.77 20.87 Total BioIndustrial 320 100 Among the Indian players, Advance Biochemicals, Biocon, and Anil Starch manufacture a amylase. Advance Biochemicals has been manufacturing and exporting cellulase enzyme for the past nine years. Currently it manufactures about 1000 metric ton per year of cellulase enzyme and exports most of it. Besides these manufacturers, there are exclusive enzymes dealers like Atul Brewchem, New Delhi, Karan Agencies of Mumbai, Southern Marketing Agency of Chengannur, Sukhjit Starch & Chemicals of Phagwara and Zytex (India). Several of the Indian manufacturers also export enzymes to the Asian, Latin American and European countries. Most of them are predominantly formulators. The formulation margins can be safely assumed at 25-30 percent. Indian companies are channelizing their efforts to develop innovative enzymes at competitive prices. Agri and pharmaceutical companies like Excel Industries and Concord Biotech (manufacturers of statins) are making inroads into this segment too. Companies are expanding their manufacturing bases. Ahmedabad-based Maps India will invest Rs 10 crore for production of new enzymes and microorganisms during the current year. It signed a memorandum of understanding with the government of Gujarat to that effect. Advanced Biochemicals is setting up a 100 percent Export Oriented Unit and is planning to invest over Rs 110 crore at Indore SEZ to manufacture cellulase, alkali protease, amylase, catalase, xylanase, acid and neutral protease enzymes. The industrial biotech sector is relatively free from regulatory complexities of biopharma and bioagri sectors. Nonetheless, it is being felt that the current situation tends to favor traders as against manufacturers. The Department of Biotechnology has taken this into consideration and has included a road map in its draft on the National Biotechnology Development Strategy to promote and develop the sector The few strategic actions mentioned include emphasis on industrial biotechnology to reduce chemical and toxic load in effluent streams, developing non-fossil fuels that are eco-friendly and developing green technologies in industrial processing and encouraging public-private partnerships to promote investment in this sector. Further, it has been suggested to promote industrial biotechnology as a strategic area of manufacturing and developing green technologies. Besides this, it is being felt that the government has to promote the use and application of enzymes in different industries and announce a package of incentives to enable new entrepreneurs to consider this sector as an investment opportunity. Also academic and research institutes in India need to come up with more commercial technologies. Institutes like Institute of Microbial Technology, Chandigarh, National Chemical Laboratory, Pune and Indian Institute of Technology (IIT), Delhi are already working on some R&D projects in the industrial enzymes segment. With least entry barriers and no social and regulatory risks involved in industrial biotechnology, the Indian companies that develop enzymes have a good future. ]]> <![CDATA[Diagnostics Business Gets Bigger]]> https://biospectrumindia.com/news/95/2179/diagnostics-business-gets-bigger.html https://biospectrumindia.com/news/95/2179/diagnostics-business-gets-bigger.html Mon, 13 Jun 2005 12:28:00 +0530 Roche consolidates. Diagnostics business crosses Rs 600 crore Pharma companies moving away from diagnostics trading. Biosuppliers to carry diagnostics products. Diagnostics sector to get special attention. With over 50 companies in the diagnostics business, the diagnostics business in 2004-05 is estimated to be Rs 602 crore. This business has been witness to several interesting trends. While Roche Diagnostics consolidated its business, after the alliance with Nicholas Piramal ended, new companies like Cancer Genetics (Genetics Specialties) have set up shop in India. Further, companies like BioRad are making good progress with their diagnostics business. BioRad's total diagnostics products business in 2004-05 was Rs 18 crore. Further, pharma companies like Dr Reddy's that were trading diagnostics products have moved away from this line of business. Roche Diagnostics is the clear leader in this market place with estimated revenues of Rs 150 crore. TransAsia Biomedicals and Goa-based Tulip Group are the two very big players, both accounting for nearly Rs 185 crore of business in 2004-05. Span Diagnostics is another Indian manufacturer, which registered close to 38 percent growth in it sales over that in 2003-04 and closed the year at Rs 49 crore. In 2004, there were about 25 companies manufacturing diagnostic kits in India. These companies have been manufacturing and selling kits mainly in the areas of pregnancy, ovulation, estimation of T3, T4 & TSH, HIV, HBV and HCV infection, rheumatoid diseases and disorders, cancer (cervix, colon, prostate, lung and mouth etc.), kidney function and liver function. DIAGNOSTIC INDUSTRY Rank Company Sales in Rs Crore 2003-04 2004-05 1 Roche Diagnostics NA 150 2 TransAsia 78.01 94.5 3 Bayer Diagnostics 55.5 64.61 4 Span Diagnostics 35.62 49 5 Nicholas Piramal 77 35.7 6 Orchid 22.9 28.71 7 Tulip Diagnostics 19.6 21.5 8 Zephyr Biomedical 7.99 18.08 9 BioRAD NA 18 10 Lilac 11 15.86 Top 10 307.62 495.96 Others 99.43 105.84 TOTALS 407.05 601.8 The total Indian diagnostics market in 2004-05 accounted for 16.5 percent of the total biopharmaceutical sector sales and saw almost a 48 percent jump in revenues during 2004-05 compared to that in the previous year. The market can be categorized into two major categories-one being reagents and allied business and the other being the instruments business. The figures mentioned above include mostly the kits and reagents and not the instrumentation. The instruments market is much bigger and we included that business in the life science suppliers' market estimates. The market is largely import-driven though there are close to 25 manufacturers. Price, quality and availability are factors driving the import of diagnostic kits into India. This is mainly because a large number of instruments are based on proprietary reagents due to the closed system. Further high import duty and custom clearance procedures, logistics, slow pace of approvals from statutory authorities, lack of national laboratory network for evaluation and approval of new products are some of the factors slowing down the pace of indigenization. However, some of the stumbling blocks are expected to go. The National Biotechnology Development Strategy Draft has a reference on "diagnostics for emerging medical paradigm" in the sectoral road map. The strategic actions include establishing a cell for diagnostic biotechnology to encourage and support studies into the clinical application of pharmacogenomics. This proposed cell is to bring pharmacogenomics to the clinical set-up and encourage research, engaging investigators with clinical practice and pharmacology and pharmacokinetics expertise. The Association of Diagnostic Manufacturers of India (ADMI) is working closely with the key authorities and agencies to appraise them of the challenges facing this industry and resolving some of those issues. With the diagnostics sector getting the strategic attention, the industry expects to register close to 30 percent growth every year for the next few years. ]]> <![CDATA[A Case for Manufacturing]]> https://biospectrumindia.com/news/95/2905/a-case-for-manufacturing.html https://biospectrumindia.com/news/95/2905/a-case-for-manufacturing.html Mon, 13 Jun 2005 12:27:00 +0530 Newer opportunities can be tapped through bio-manufacturing services. Decades of investment in Biotechnology Research have fueled a market for biopharmaceutical products that is expected to grow from about $35 billion in 2005 to over $70 billion by 2010. With over 300 large molecules currently in clinical development, therapeutic proteins and antibodies from recombinant technologies will soon become the leading source of new products and growth in pharmaceutical industry. The exciting market opportunity presents the biopharmaceutical industry with a new challenge to manufacture enough products to meet the growing demand. During the last two decades, India has emerged as a preferred destination for cost competitive quality production of pharmaceutical API and formulations. Today, India enjoys the distinction of having the maximum number of US FDA approved facilities anywhere in the world outside of the US and has proven its claim to be a major manufacturing hub and supply centre to the world. With the Indian IPR laws in place, the pharma manufacturing sector is expected to leap. There is an acute shortage of bio-manufacturing capacity globally. And there is a case for the Indian biopharmaceutical company to offer manufacturing services as it can provide a competitive cGMP facility, with skilled manpower and scientific talent, along with a good cGMP culture, among several other things. Nonetheless, investments in bio-manufacturing facilities involve considerable risk. A manufacturing strategy for a biopharmaceutical molecule must be determined early in the development process. Current regulatory position "Product by Process" does not allow choices to the developer to make alteration and / or change of manufacturing facility. This stance of US FDA and EMEA is the main issue of contention to allow (or not to allow) generic biologicals. An amendment to this position would open opportunities for contract manufacturers to participate on toll manufacturing contracts for original developer of molecules and for manufacturing and marketing a generic version of the same on the expiry of the Patents. Till then, the risk of clinical or regulatory failure would be one of the key project uncertainties that would have to be factored in any investment decision. The commercial potential of the drug at this juncture is a significant unknown. The biopharmaceutical molecule manufacturing processes are far more complex than synthetic, less flexible to be adopted for alternate products. They involve both large investments and long lead times. Further, the current market size both in quantity and value terms outside the regulated markets is small. It is also possible that potentially disruptive new technologies, such as highly productive expression systems or perhaps transgenic plants, may make existing manufacturing process obsolete. Biopharmaceutical manufacturers wishing to participate in this opportunity must make strategic choices regarding capacity, technologies, expression systems and capabilities in the face of these uncertainties. Surely, Indian biopharmaceutical companies having developed a viable business model and capabilities across the full value chain from research-to-marketing would stand a better chance to participate in this opportunity as their current business would allow them to mitigate the associated risks. Unlike therapeutic proteins and antibodies, which have limited market both in quantity and value terms in developing world, vaccines offer a large market in quantity and more friendly-regulatory environment. The active participation of organizations, like WHO and other National Health Agencies in developing countries, in the vaccination programs offers a ready market without considerable investment in marketing network. India is already recognized as a key supplier of conventional pediatric vaccines for the global market and will consolidate further in the next few years by adding manufacturing capabilities to produce much needed newer vaccines using newer technologies. KI Varaprasad Reddy managing director, Shantha Biotechnics and member ABLE ]]> <![CDATA[Biotech Industry: IPR and Other Legal issues]]> https://biospectrumindia.com/news/95/8310/biotech-industry-ipr-and-other-legal-issues.html https://biospectrumindia.com/news/95/8310/biotech-industry-ipr-and-other-legal-issues.html Mon, 13 Jun 2005 11:51:00 +0530 Intellectual Property in India has remained a mystery to many, the main reason being ignorance. Since 1991 when India took the first step towards liberalization of its economy, there has been a constant progress in the area of Foreign Direct Investments (FDI) in Indian companies. With the Government of India having virtually abandoned the "licence raj", FDI is happening in almost all the sectors, barring certain sensitive areas such as nuclear power and agriculture. The Government of India classifies various industries into a number of sectors. While 100 percent FDI is allowed in most of the industries, restrictions are imposed in certain sectors such as telecom, print and media, which are called as "sectoral caps". Biotechnology as such is not classified as a specific sector nor is there any specific definition available in the statute. Perhaps this might be one of the reasons which made a number of entities proclaim themselves as biotech industries despite having nothing to do with biotechnology. Without going into the controversies surrounding such claims, one can broadly classify the biotech industry into agri-biotech, bioinformatics, pharma biotech, industrial biotech, biotech research services and biotech supplies. Agribiotech has made a tremendous contribution into India's green revolution.But this growth could have been better had there been no restrictions imposed by many states in India on corporate entities holding agricultural land and carrying out research activities. The Karnataka government has now amended its Land Reforms Act which would enable agro-based companies to acquire agricultural land for the purpose of its business. By and large, barring a few companies in India, the R&D work in the agricultural segment has happened in government labs and universities. Given the present socio-economic background of rural India, it is not a surprise to see opposition to the introduction of biotech seeds, especially Bt cotton. This situation is due to lack of consistent procedural law for testing, accepting, distribution and sale of seeds among various states and above all, lack of a credible agency which would place the facts before the masses. On account of the initiative of organizations such as ABLE, the Government of India recently appointed a task force headed by Prof MS Swaminathan to streamline the regulatory process for the benefit of this industry. Bio-IT and Bio-informatics There has been a significant growth in the bioinformatics area which includes curatorial services, data banks, support services in healthcare such as online diagnostics, online medical consultations and also extends to claims processing and hospital data management. Being an Information Technology-driven segment, the Bio-IT industry would fall within the scope of the Information Technology Act 2000 (IT Act). This law recognizes digital data, in whatever form it may be, as an evidence acceptable in a court of law. Even though there is no specific law for data protection or privacy, The IT Act can be an effective tool for data protection and can be implemented for any willful data loss or misuse. Industrial biotech would mean the manufacture and production of enzymes used for healthcare, drugs, breweries, chemical industries, garments, leather, and food processing etc. The general law that would govern such activity would be the Factories Act and related industrial law and depending upon the nature of work certain enactments cited under pharma biotech would apply. Pharma biotech signifies the outcome of intense research and development in drugs and chemicals which involves testing at various levels and ending in manufacture and distribution of drugs. This industry comes under the stringent provisions of The Drugs (Control) Act 1950, The Drugs and Cosmetics Act 1940, the Patent Act 1970 and falls within the purview of various regulators. The Indian pharma industry has made considerable progress and has also made inroads into other third world countries. There are a few disputes regarding patent infringement. One needs to wait and watch the ruling of the courts and enforcement of any decrees beyond the territorial jurisdiction of a country in which the decree is passed. Foreign companies were hesitant to introduce new drugs without the product patent regime in India. The amendment to the Patent Act 1970 allowing product patent needs to be observed as it is too early to see the trend. Thanks to the efforts of ABLE, the Union Government has formed a high-level task force headed by Dr RA Mashlekar to streamline the regulatory process under the "Rules for Manufacture, Use, Import, Export and Storage of hazardous micro organisms / Genetically Engineered Organisms or Cells 1989" notified under the Environment (Protection) Act, 1986 Research ServiceForeign biotech and pharma companies find India as an attractive destination to carry out biotechnology-related research on contract basis. This is due to the availability of domain experts and low establishment cost. This win-win enterprise is seen as a major source of forex earner for the country. Foreign Direct Investment Prior to the setting up of any company in India, one needs to find out whether FDI is permitted in that particular sector. As mentioned earlier, the FDI policy does not classify biotechnology as a specific industry. While FDI in agriculture per se is not allowed, there are no prohibitions in the agri-biotech industry. Foreign Direct Investment upto 100 percent is allowed in pharmaceutical and drug industries. However, no FDI is allowed in industries involved in recombinant DNA technology and specific cell / tissue formulations, In such cases, prior approval has to be obtained from the Secretary Industry Assistance (SIA), Government of India, followed by an approval by the Foreign Investment Promotion Board (FIPB). However, no specific license is required for a contract research unit which deals with recombinant DNA technology so long as there is no commercial production of drugs or pharmaceuticals emanating from such R&D work in India. Even though there is no written code to this extent, investors are advised to seek endorsement from the Department of SIA, that says no specific license is required for mere R&D work when there is no commercial production. A company can be incorporated in India within 45 to 60 days from the date of application. However, one needs to get the name approved from the appropriate Registrar of Companies, which is granted within six working days before making such an application. Intellectual Property Intellectual Property (IP) in India has remained a mystery to many and the main reason for this is ignorance of both law and facts. While issues regarding Trade Mark and Copyright may not be all that relevant to the biotech industry, the Patent Act 1970 has a major impact. India is one of the first few countries to have its Patent law in place which was evolved on the basis of its socio and economic conditions - a law that would support its closed-door economy. India having become a signatory to the TRIPS agreement (Trade Related Aspects of Intellectual Property Rights) had to adhere to the pledge made in the agreement by carrying out considerable amendments to the Patent Act 1970. These amendments were effected into two phases - first in the year 2002 and lastly in 2005. Some of the salient provisions of the Indian Patent Act relevant for the biotech industry are - The following are not patentable: Mere discovery of a scientific principle or the formulation of an abstract theory. Or discovery of any living thing or non-living substance occurring in nature. The mere discovery of any new property or new use for a known substance or of the mere use of a known process, machine or apparatus unless such known process results in a new product or employs atleast one new reactant; A substance obtained by a mere admixture resulting only in the aggregation of the properties of the components thereof or a process for producing such substance; Any process for the medicinal, surgical, curative, prophylactic (diagnostic therapeutic) or other treatment of human beings or any process for a similar treatment of animals to render them free of disease or to increase their economic value or that of their products. Plants and animals in whole or any part thereof other than micro-organisms but including seeds, varieties and species and essentially biological process for production or propagation of plants and animals; By the Amendment Act of 2002, the law has been made clear that any plant, animal in whole or any part thereof, including seeds, varieties and species which have been processed using biotechnological means cannot be patented. However, there is an exception to the extent that any micro-organism which has been created using biological process is patentable. Prior to the Amendment Act 2005, Section 5 of the Patent Act did not allow grant of Product Patent to inventions relating to drugs, chemicals and food processing. In line with the TRIPS, such restriction was dropped and the inventions mentioned, can qualify for the grant of product patents too. Another significant amendment is that mere discovery of a new use for a known drug cannot be patented. With effect from January 1, 2005, fresh grant of exclusive marketing rights remains abolished. Answering to global needs, India has introduced a new provision for compulsory licensing of pharmaceutical products. When at the request of any country facing a shortage of a patented drug, and that country having ordered compulsory licensing, but not in a position to manufacture such a drug, India can order compulsory licensing of such a patented drug exclusively for the purpose of export to that country alone. B C Thiruvengadam Thiru & Thiru Advocates thirus@vsnl.com     ]]> <![CDATA[$10 Billion Bioinformatics Dream]]> https://biospectrumindia.com/news/95/1942/10-billion-bioinformatics-dream.html https://biospectrumindia.com/news/95/1942/10-billion-bioinformatics-dream.html Mon, 13 Jun 2005 11:48:00 +0530 Though small, the industry wants to be part of a $10 billion dream. The global bioinformatics market was valued at around $697 million in 2001 and is expected to increase to around $1.7 billion by 2006. There are three areas of opportunities in bioinformatics for India. At the highest level is the integrated research application service providers. Then there are the providers of data base services and discovery software. The software requirements of the biotech industry include micro array analysis, database software, sequence analysis, visualization software, array management and testing in silico. It is possible to achieve a 5 percent global market share [of bioinformatics] by 2005, [which is] a $3 billion opportunity in India," says a CII study published in February 2004. Ashok Kolaskar, who chairs the Department of Biotechnology task force on bioinformatics, is confident of the Indian bioinformatics industry earning $2.5 billion by 2008. "It is already earning $400 million and pushing it six times is not unrealistic," he says. Source: Nature Biotechnology 22, 933 (2004) Companies in India The bioinformatics industry is mushrooming around the IT services centers. That is why we see a lot of companies based in the South, especially in Bangalore, Hyderabad and Chennai with few companies in the North. Accelrys, Bigtec, CytoGenomics Genotypic, Jalaja Technologyis, Infosys, Kshema Technologies, IBM India, SysArris Software, Systat Software and Strand Genomics are some of the leading names that have a base in Bangalore. BioMed Informatics, GVK Biosciences, Caliber Technologies, Bijam Biosciences, a company of the Nagarjuna group, BioMakro, Helix Genomics, Molecular Connections, TCS, Ocimum Biosolutions and Shakti Bio Systems are based in Hyderabad. The industry is small and is estimated to be Rs 80 crore in size. The Indian players are also small but they have been developing global products and quality services. CytoGenomics, Helix Genomics, LabVantage, Mascon Life Sciences, Ocimum Biosolutions, SciNova Technologies, Strand Genomics, TCS, and VLife Sciences have come up with a suite of products, which are gaining global acceptance. Today most of the companies in this segment are small to mid size, with employees ranging from 25 to 200 plus and the average man to women ratio is 2:1. The salary range depends on the experience and capabilities of the person and performers are recognized and well rewarded. While the starting salaries could be anywhere from Rs 10,000 to Rs 20,000 per month depending on the experience of the candidate, it can go up very high as there is a review every six months. The salaries offered can start from Rs 1.8-2 lakh per annum and can reach as high as Rs 12-15 lakh per annum based on the experience and type of skills. Bioinformatics Policy of India (BPIâ€“2004) The Department of Biotechnology, Government of India, has identified bioinformatics as an area of high priority during the tenth plan period to ensure that this sector attains levels demanded in the international arena. The BPI has its focus on resource building in bioinformatics using the infrastructure already available and to ensure venture capital funding for public-private partnership in bioinformatics. The objective is that India should create a niche in bioinformatics industry and make bioinformatics a $10 billion industry by the end of 10th Plan period. Dr Pravin Kini Managing Director, CytoGenomics, Bangalore ]]> <![CDATA[Agribiotech]]> https://biospectrumindia.com/news/95/3602/agribiotech.html https://biospectrumindia.com/news/95/3602/agribiotech.html Mon, 13 Jun 2005 11:47:00 +0530 By 2010, India can become a major grower of transgenic rice and several vegetables. The commercial approval of the first transgenic crop in this country, Bt-Cotton happened after an unreasonable delay of several years in 2002. Since then, the importance of transgenic crops and other biotechnological tools in improving our crops is being increasingly recognized. While the farmers in this country have always been receptive to new technologies, the perception about transgenic crops among the other sections of the society, as reflected in what appears in the print and visual media, has seen a sea change - from outright cynicism to one of cautious acceptance. It is clear that in an agrarian economy like ours biotechnology can effectively address the twin challenges of stagnating productivity and poor nutritional quality. The growing population and improving life-styles is pushing up the demand considerably. For e.g., it is estimated that we would need to produce at least 40 million more metric tons of rice by 2020 just to satisfy the internal demand, and this would not be possible with the current levels of productivity increases in rice, which is just under 1.5 percent per year. Infusion of new biotechnological tools in rice improvement programmes that has the potential to break the current productivity barriers is a powerful option. The area under Bt-Cotton has increased over 20 times in the last three years of its commercial cultivation, in spite of its relatively high price. The tangible benefits conferred by this crop is for everyone to see and this has to a large extend silenced the full-time critics of agricultural biotechnology. The Government has also woken up to the enormous potential of such technologies and is keen to put in place policies and regulations which will promote responsible crop biotechnology. In short, agricultural biotechnology in this country is at the take-off stage. Between 2002 and now, over a dozen hybrids carrying the Cry1Ac Bt-gene of Monsanto has been given commercial approval. This number will more than double, in the next two years with more licensees of this gene, going through the regulatory process. In parallel, several other organizations have introduced different Bt-genes into cotton and other crop species including rice and these are also under advanced testing. These organizations include several multinational and local companies, and several public research institutes. With increasing choices and the competition, the cost of Bt cotton technology to the farmer is bound to go down, while the area will grow from the present 15-20 percent to more than 90 percent of the hybrid-cotton area in the next five years. Other crops in which transgenic technologies will be extensively deployed include rice and several species of vegetables and the traits of interest would be insect-protection, tolerance to drought and other abiotic stresses, tolerance to bacterial and fungal diseases, and nutritional enhancement. The research on modified crops expressing proteins of diagnostic and therapeutic value is still in its embryonic stage in the country, however, these efforts can also be expected to reach fruition by 2020. Many seed companies in the country are beginning to invest significantly in crop biotechnology. Several of them already have capabilities to leverage Marker Assisted Selection technologies to augment their crop improvement programmes. They are now moving towards crop genetic transformation approaches, either by building the capabilities in-house, or by striking partnership with other institutions. Today, meaningful public-private partnerships are too few and far between, but growing need for development and sustained deployment of agricultural biotechnology products will foster many such relationships in the near future. Today, the world grows over 80 million hectares of transgenic crops with North America leading the world in acreage under such crops. India has been a very recent entrant entrant in this league with the present transgenic-crop acreage constituting less than a percentage of total global acreage. If the current trend of growth of Bt Cotton is any indication, it will not be surprising if India beats North America to the number one position within the next 15 years. KK Narayanan Managing Director, Metahelix Life Sciences, Bangalore, and Member, ABLE ]]> <![CDATA[Agribiotech's Future Very Bright]]> https://biospectrumindia.com/news/95/2887/agribiotechs-future-very-bright.html https://biospectrumindia.com/news/95/2887/agribiotechs-future-very-bright.html Mon, 13 Jun 2005 11:45:00 +0530 y 2010, India can become a major grower of transgenic rice and several vegetables. The commercial approval of the first transgenic crop in this country, Bt-Cotton happened after an unreasonable delay of several years in 2002. Since then, the importance of transgenic crops and other biotechnological tools in improving our crops is being increasingly recognized. While the farmers in this country have always been receptive to new technologies, the perception about transgenic crops among the other sections of the society, as reflected in what appears in the print and visual media, has seen a sea change - from outright cynicism to one of cautious acceptance. It is clear that in an agrarian economy like ours biotechnology can effectively address the twin challenges of stagnating productivity and poor nutritional quality. The growing population and improving life-styles is pushing up the demand considerably. For e.g., it is estimated that we would need to produce at least 40 million more metric tons of rice by 2020 just to satisfy the internal demand, and this would not be possible with the current levels of productivity increases in rice, which is just under 1.5 percent per year. Infusion of new biotechnological tools in rice improvement programmes that has the potential to break the current productivity barriers is a powerful option. The area under Bt-Cotton has increased over 20 times in the last three years of its commercial cultivation, in spite of its relatively high price. The tangible benefits conferred by this crop is for everyone to see and this has to a large extend silenced the full-time critics of agricultural biotechnology. The Government has also woken up to the enormous potential of such technologies and is keen to put in place policies and regulations which will promote responsible crop biotechnology. In short, agricultural biotechnology in this country is at the take-off stage. Between 2002 and now, over a dozen hybrids carrying the Cry1Ac Bt-gene of Monsanto has been given commercial approval. This number will more than double, in the next two years with more licensees of this gene, going through the regulatory process. In parallel, several other organizations have introduced different Bt-genes into cotton and other crop species including rice and these are also under advanced testing. These organizations include several multinational and local companies, and several public research institutes. With increasing choices and the competition, the cost of Bt cotton technology to the farmer is bound to go down, while the area will grow from the present 15-20 percent to more than 90 percent of the hybrid-cotton area in the next five years. Other crops in which transgenic technologies will be extensively deployed include rice and several species of vegetables and the traits of interest would be insect-protection, tolerance to drought and other abiotic stresses, tolerance to bacterial and fungal diseases, and nutritional enhancement. The research on modified crops expressing proteins of diagnostic and therapeutic value is still in its embryonic stage in the country, however, these efforts can also be expected to reach fruition by 2020. Many seed companies in the country are beginning to invest significantly in crop biotechnology. Several of them already have capabilities to leverage Marker Assisted Selection technologies to augment their crop improvement programmes. They are now moving towards crop genetic transformation approaches, either by building the capabilities in-house, or by striking partnership with other institutions. Today, meaningful public-private partnerships are too few and far between, but growing need for development and sustained deployment of agricultural biotechnology products will foster many such relationships in the near future. Today, the world grows over 80 million hectares of transgenic crops with North America leading the world in acreage under such crops. India has been a very recent entrant entrant in this league with the present transgenic-crop acreage constituting less than a percentage of total global acreage. If the current trend of growth of Bt Cotton is any indication, it will not be surprising if India beats North America to the number one position within the next 15 years. KK Narayanan Managing Director, Metahelix Life Sciences, Bangalore, and Member, ABLE ]]> <![CDATA[Biotechnology, India]]> https://biospectrumindia.com/news/95/1446/biotechnology-india.html https://biospectrumindia.com/news/95/1446/biotechnology-india.html Mon, 13 Jun 2005 11:43:00 +0530 Biotechnology in India holds a great promise in the future. When Watson and Crick discovered the double helix structure of DNA in 1953, it was a major breakthrough in biology. The last five decades have seen some truly amazing developments in the field of biotechnology. We are on the threshold of a new and exciting era where basic sciences, powered with proteomics, genomics, metabonomics, high-powered computing and bioinformatics and increased focus on evidence-based medicine are poised to revolutionize the way we treat diseases. Simply defined, biotechnology deals with the application of biological knowledge and techniques pertaining to molecular, cellular and genetic processes to develop significantly improved products and services. Its applications range from agriculture, industrial and medical biotechnology. As the regional head of a global pharmaceutical company, I would elaborate on biotechnology and bioinformatics as used in our pursuits of diagnosing diseases and curing them with newly developed drugs Where will biotechnology add value in drug discovery? Biotechnology can potentially add value at every step in modern drug development-from Discovery Research to Commercialization. For example at early stage in drug development, genetics plays a vital role in identifying new drug targets, disease mechanisms and refining high throughput screens. Modern genetics is expected to even identify the right medicine for the right patient. In other words, not too far from now, we may have drugs tailor-made for individual patients to maximize efficacy and minimize side effects Like genetics, metabonmics is expected to have a compelling impact on diagnosis and treatment of diseases. Metabonomics is the quantitative measurement of time-related multiparametric metabolic responses of multicellar systems to pathophysiological stimuli or genetic modification. Research in biotechnology can also have huge applications in "diseases of the developing world". For example, scientists at the Imperial College in London are working on pioneering basic research to develop new methods to control malaria. The approach is a fundamental change in strategy-to attack the parasite in the vector rather than the human subject. Three concepts are being explored: Determination of structure/function of parasite molecules regulating infection of mosquito so as to develop anti parasitic vaccines & drugs Analysis of mosquito immune responses that kill parasites so as to identify genes needed to design genetically modified refractory insects Methodology needed to construct GM mosquitoes and to drive the genes into natural insect population. GSK's contribution in biotechnology Recognizing its immense potential in discovery of breakthrough medicines, biotechnology is now a key investment area within GSK global R & D. GSK biotechnology research has resulted in some major breakthroughs in drug discovery. Scientists at Glaxo Wellcome (now GSK) identified PPARg as the receptor for a group of drugs called Glitazones. This opened up a completely new way of treating diabetes with insulin sensitizing drugs. Scientists at GSK have used pharmacogenetics to improve the risk benefit ratio for Ziagen, an antiretroviral drug. Ziagen is a highly effective Anti HIV medicine. But Hypersensitivity reactions occur in 5 percent of the patients. Scientists at GSK compared the DNA of patients who experienced hypersensitivity reactions with those who did not, looked for differences in genes that may be involved in the reaction and thereby identified patients at risk A number of new vaccines, especially for the developing world, are either on way to the market or at late stages of development. Our breakthrough offering will be in the form of a cancer prevention vaccine called Cervarix, which will provide Indian women protection against HPV, which causes cervical cancer. About 1lakh children die in India every year due to gastro enteritis caused by Rota virus. GSK's Rotarix offers an opportunity to save their lives. GSK also has a late stage vaccine candidate for malaria. If clinical trials find our confidence in the vaccine appropriate, it will start providing protection to the world's children from falciparum malaria in a few years from now. Work is also on for developing new vaccines for protection against TB, Dengue and HIV. Bright future for Biotechnology in India With such exciting prospects, it is not surprising that the global biotech industry is expected to grow in leaps and bounds. Sales of biotech products are slated to reach over $ 60 billion by 2015. According to a recently concluded study, Indian biotech industry's R&D and services will reach a turnover of $3 billion by 2010 and bioinformatics market will cross $2 billion. The size of Indian pharmaceutical market is currently estimated to be $4.5 billion. In other words, biotech and bioinformatics together are going to develop into a huge market in next five years, equivalent to today's pharma industry. This truly presents an unprecedented business and career opportunity in the years to come, fully deserving to be called India's supernovas. Some of India's strengths include: A knowledge pool in biosciences and engineering of over 3 million graduates,700,000 post graduates and 15,000 PhDs A strong multinational presence offering Indian talent exposure to cutting age technologies and opportunity to work in state of the art research projects A significant presence in areas such as conventional generics and track record based on process engineering skills. Cost advantage A robust IT industry which has already established India's credentials as a viable investment destination, and Presence of a well-defined user industry, i.e. pharmaceutical industry The recent introduction of Intellectual property law provides just the right kind of environment to encourage research in this highly potential area. What would be more important would be data exclusivity to provide even a better environment for scientists and the industry to invest in biotechnology. The biotechnology sector in India is growing rapidly at a rate of over 40 percent annually. India is the largest producer of recombinant Hepatitis B vaccine in the world today. The country is also emerging as global player in recombinant Human Insulin. In addition, Indian vaccine market, which is over $100 million, is growing at over 20 percent annually. As vaccines are one of the most cost-effective healthcare interventions, I expect the government of India to expand its programme of immunization in the years to come. When this happens, the Indian vaccine market will grow exponentially. Clinical services are now a global opportunity for India with a strong competitive edge based on speed and quality of clinical development. GSK India is currently conducting 9 clinical trials for its parent. This number is likely to increase significantly in the future. GSK has plans to conduct clinical trials for Hep E vaccine with India in mind. Indian regulatory authorities have displayed mature understanding towards this project and as a result, we are getting excellent co-operation from them. Bioinformatics and research services are yet another fast growing segment where a number of multi national companies are setting up their base in India. GSK set up its data management centre in Bangalore in 1996, much before outsourcing became a buzzword. Our teams at CDMCI handle data of our global trials and strictly conform to global standards such as ICH GCP. I am optimistic about the country's rapidly growing strengths and capabilities in biotechnology. I am confident that it can emerge as a powerful growth engine for the Indian healthcare industry and help in its global aspirations. S Kalyanasundaram Managing Director, GlaxoSmithKline Pharmaceuticals ]]> <![CDATA[Overcoming challenges facing clinical trials in India]]> https://biospectrumindia.com/news/95/1832/overcoming-challenges-facing-clinical-trials-in-india.html https://biospectrumindia.com/news/95/1832/overcoming-challenges-facing-clinical-trials-in-india.html Mon, 13 Jun 2005 11:31:00 +0530 Regulatory uncertainties, involvement of multiple agencies for approval of biotech products and several other factors are hurdles in planning a clinical trial in the country. India is attracting a lot of attention as a new region for conducting global clinical trials. The 2010 projections for the Indian clinical market of $1.5-2 billion are based on the likelihood that Indian trial sites can contribute almost 20 percent patients to global clinical trials â€“ the current acceptable FDA limit for data from developing country population. However, the current contribution of Indian affiliates of global CROs is around one percent of the global turnover. The journey from one percent to 20 percent is fraught with several challenges. From the global pharma industry view point, the attractiveness of a country for clinical trial depends on speed and quality of data. The speed is affected by the following factors: regulatory permission time, Ethics Committee (EC) approval, patient recruitment and retention. The quality of data is largely influenced by GCP culture, ethics, documentation and record keeping. Global pharma companies are concerned about India's potential for meeting these challenges. The regulatory uncertainties about time to approval, involvement of multiple agencies for approval of biotech products and for processing import/export licenses are a major stumbling block in planning a trial. In addition, the lack of uniformity of EC functioning and absence of a central EC delay the trial initiation. As most institutions lack organized patient databases, the patient recruitment rates are either underestimates or overestimates. Besides, it is difficult to obtain real estimates for diseases of global interest, for example refractory depression. Retention of patients in today's long and complex trial process depends on the investigator team's communication skills and relationship with the subject. There is also a major impact of patient literacy, society's attitude and bad media publicity on the recruitment and retention of patients in trials. The factors influencing quality of data depend a lot on the GCP culture and training of the investigator site staff and in the sponsor / CRO team. In a country which boasts of a large medical fraternity, only 400-500 investigator sites have taken part in global GCP trials. A large majority of potential investigators lack knowledge of regulations, ethics and GCP, and skills for clinical trial management. The quality of global trials and academic clinical research is not uniform. There are also issues of inadequate permanent research staff and lack of adequate infrastructure for communication, drug / sample storage, archival. The situation is worse in non-metro cities which have tremendous potential for participation in global trials. In addition, the institutional policies are not yet geared up to support the investigator in managing clinical trials efficiently. The regulatory authorities and ECs have a major role to play in the quality of data generated. The EC's efforts to continuous review and regulatory system for inspection are a must to ensure that the subject's rights and safety are protected and data generated meet GCP standards. We have significant opportunities of participation in global clinical trials. However, if we want India's contribution to rise from one percent to 20 percent, it would require tremendous efforts from all stakeholders â€“ regulators, investigators, sponsor/CRO and ethics committee â€“ to cooperate in overcoming the challenges. Dr Arun Bhatt President, ClinInvent Research India Pvt Ltd, Mumbai arunbhatt@clininvent.com ]]> <![CDATA[Bioinformatics, the Next Sunrise Industry]]> https://biospectrumindia.com/news/95/5257/bioinformatics-the-next-sunrise-industry.html https://biospectrumindia.com/news/95/5257/bioinformatics-the-next-sunrise-industry.html Mon, 13 Jun 2005 11:29:00 +0530 Bioinformatics is the computer assisted data management discipline that helps us gather, analyze, and represent information in order to educate ourselves, understand life's processes in the healthy and disease states, and find new or better drugs. Pharmaceutical companies are achieving increased research efficiency by the introduction of new approaches to the design, synthesis, screening and optimization of drug candidates. Information Technology (IT) is an important support function for all of those activities and there are certain functions and operations that cannot be performed without IT. Informatics represents the deployment of software systems like Sapphire to manage, analyze, and store biological data. Beyond data management, informatics represents the only way to analyze large pools of genomic information. Future for IT in Biotechnology in India India is on the verge of taking the global leadership in genome analysis. India has several ethnic populations that are valuable in providing information about disease predisposition and susceptibility, which in turn will help in drug discovery. Institute of Genomics & Integrated Biology (IGIB), New Delhi is in the process of developing a database of genetic profiles among diverse Indian population in terms of ethnicity, demographics and ancestral roots. This voluminous database is well supported by LabVantage Sapphire. However, as there is lack of records and data management capabilities, the biotech and pharma companies need tremendous software support. Software expertise is required to write algorithms, develop software for existing algorithms, manage databases, and help in data collation in final process of drug discovery. Major opportunities for IT companies include: Effective utility of the various data sources and collation thereof. Developing better tools for data generation, data capture, and annotation Developing and improving tools and databases for comprehensive functional studies including project management. Sharing of data and generating useful information from the database. Integration of heterogeneous information. Designing and developing a comprehensive solutions in assisting every process involved in biotechnology and drug discovery and ensuring that software should be able to take the scientists beyond the walls of laboratory. Pure cost benefits for the biotech companies will definitely drive the bioinformatics industry in the country. The biotech industry is seen spending heavily on their R&D. Thus to maintain their data the biotech companies will be forced to outsource software to dedicated IT companies in pharma and biotech segment like ours rather than developing propriety software. It also helps in bringing about standardization and discipline in the field, by automating some tasks and introducing checks in the process where regulatory compliances play a key role. This however has become standard practice in most countries, and those that don't follow it will find it hard to keep pace with continuous developments in this area. IT has become a critical factor in pharmaceutical research and development (R&D). Growth in the informatics industry is based on the investments in R&D. The convergence of biotechnology and computing has already resulted in a number of alliances, which could result in mergers between previously distinct industries. In future, we may see a combination of pharmaceutical and computing firms bringing together their research as well as IT capabilities. In future, we may see alliances between pharmaceutical, software as well as firms, which have strong marketing capabilities. The field would also witness the entry of new players such as computing and telecommunication firms. Anil Kastuar President, LabVantage Solutions Pvt Ltd, Kolkata ]]> <![CDATA[Vaccines Push BioPharma Sales]]> https://biospectrumindia.com/news/95/2621/vaccines-push-biopharma-sales.html https://biospectrumindia.com/news/95/2621/vaccines-push-biopharma-sales.html Mon, 13 Jun 2005 11:24:00 +0530 The total BioPharma industry, comprising of vaccines, therapeutics, other products like statins, and diagnostics registered 29.72 percent growth in 2004-05 and the segment still is the single largest contributor to the Indian biotech industry. The total biopharma industry grew from Rs 2,752 crore in 2003-04 to Rs 3,570 crore. The vaccines business is the prime contributor, accounting for close to 47 percent of the total biopharma business, which also includes the diagnostics market. The vaccines business grew from Rs 1,295 crore in 2003-04 to Rs 1,669 crore in 2004-05. While the human vaccines business saw close to 28 percent growth, the animal vaccines business has grown by over 75 percent. In fact, Venkateshwara Hatcheries' poultry vaccines business grew by over 113 percent to Rs 188 crore in 2004-05. Indian Immunologicals, another major animal healthcare manufacturer, registered a strong 29 percent growth to end the year at Rs 72.38 crore. Interestingly, these animal health care companies now are expanding the manufacturing expertise to human health care in a big way. The therapeutics market recorded 20 percent growth and grew to Rs 500 crore in 2004. The competition in the human insulin segment has increased with the launch of human insulin products by Biocon and Shreya Life Sciences. As a result of this pricing pressure is expected in this segment. Biocon was the largest biopharma company with total pharma sales of Rs 556.67 crore. Serum Institute of India was the second largest player with total sales of Rs 505 crore. While Biocon recorded 27.86 percent growth, Serum registered 2.85 percent growth in its sales. Panacea was the third largest company with total sales of Rs 217 crore. It registered 45.8 percent growth over that in 2003-04. Venkateshwara Hatcheries was the No. 4 company with total sales of Rs 188 crore. This is the first time that an animal health care company is entering the Top 5 club. Further, the Indian (home grown) manufacturers today account for 62 percent of the total BioPharma sector (excluding the diagnostics market which is valued at Rs 601 crore). Among the top five companies, Novo Nordisk is the only MNC. Most of the biotech companies today are focusing on discovery-led innovation and investing in infrastructure and R&D. During 2004-05, Biocon's total investment increased to Rs 103.24 crore from Rs 64.44 crore the previous year, a 60 percent growth in its R&D investments. Biological E has invested about 36 percent of its total turnover on infrastructure and R&D. While Rs 35 crore went into the infrastructure development, Rs 1.1 crore was for R&D. Panacea has recently developed and launched several other vaccines, which include Recombinant Hepatitis B (Enivac HB), Enivac HB Safsy, Ecovac (DPT+Hib B), Ecovac safsy, Easy Four (DPT+Hib) and Easy Five (DPT-Hib-HepB). It also entered into a collaboration with UK-based Cambridge Biostability, for manufacturing of vaccines in India using the Stable Liquid Technology. This is a sample list of some of the developments. Clearly, one is seeing increased collaborations, mergers and acquisitions, and newer investments. Most companies expect the their investments to yield the returns in another two years time. Top Indian Manufacturers* Rank Company Turnover in Rs Crore (2004-05) 1 Biocon 556.67 2 Serum Institute of India 505 3 Panacea Biotec 217.28 4 Venkateshwara Hatcheries 188 5 Bharat Serums 81 6 Indian Immunologicals 72.38 7 Shantha Biotechnics 68.85 8 Wockhardt 67 9 Bharat Immunological & Biological Corp. 53.25 10 Bharat Biotech International 41 Top 10 Indian Manufacturers 1848.43 Others 1119.8 Total BioPharma 2970.23 Top 10 Indian Manufacturers Account for 62 percent of the total BioPharma Sector *Excluding Diagnostics Companies                           Total BioPharma Sector including Diagnostics BioPharma Revenues in Rs Crore (2003-04) Revenues in Rs Crore (2004-05) Percentage Growth Vaccines 1295 1669 28.88 Therapeutics 415 500 20.48 Others 635 800 25.98 Total 2345 2969 26.61 Diagnostics 407 601 47.67 Total Pharma 2752 3570 29.72   Contribution of BioPharma Companies* Club 2004-05 Revenues in Rs Crore % Contribution Top 5 1599.95 53.87 Top10 1993.45 67.11 Top15 2315.93 77.97 Top 20 2487.23 83.74 *Excluding Diagnostics Companies   Market Share of BioPharma Companies* Company % Share Biocon 18.74 Serum Institute of India 17 Panacea Biotec 7.32 Venkateshwara Hatcheries 6.26 Novo Nordisk 4.55 Aventis Pharma 2.84 Bharat Serums 2.73 Chiron Behring Vaccines 2.63 GlaxoSmithKline 2.62 Indian Immunologicals 2.44 Shantha Biotechnics 2.32 Eli Lilly and Company 2.3 Wockhardt 2.26 Serum International 2.19 Bharat Immunological & Biological Corp. 1.79 Bharat Biotech International 1.38 Biological E 1.24 Haffkine Bio-Pharmaceuticals 1.13 Krebs Biochemicals 1.01 Dr Reddy's 1.01 Others 16.26   100 ]]> <![CDATA[BioAgri is the Fastest Growing Sector]]> https://biospectrumindia.com/news/95/6411/bioagri-is-the-fastest-growing-sector.html https://biospectrumindia.com/news/95/6411/bioagri-is-the-fastest-growing-sector.html Mon, 13 Jun 2005 11:05:00 +0530 The BioAgri sector has come of age in India. In 2004-05, Rasi Seeds became the second company in India to make commercially available Bt cotton. With the entry of Rasi, the entire Bt cotton seeds business changed. The release of RCH 2 Bt in 2004 by Rasi has created greater confidence in the farmers about Bt technology. The farmers have understood that they get maximum benefit using hybrids with Bt technology and there is huge demand. *Mech-162 Bt and Mech-184 Bt of Mahyco-Monsanto can be cultivated in south India with the exception of Andhra Pradesh The total Bt cotton seeds revenues in 2004-05 was Rs 253.3 crore, a record growth of 369 percent compared to Rs 54 crore in 2003-04. A total of 15.8 lakh packets of seeds containing 450 grams were sold. The total seeds sale was 7.11 lakh kg. The "Bollgard" Bt cotton seeds were sold in six states-Andhra Pradesh, Tamil Nadu, Karnataka, Gujarat, Madhya Pradesh and Maharashtra. Rasi Seeds in 2004-05 reported total Bt cotton seeds sales of Rs 86.9 crore. Mahyco-Monsanto, the first company permitted to sell Bt cotton, was estimated to have grown over 208 percent to end the year at Rs 166.4 crore. The total bioagri sector in the country was estimated at Rs 330 crore, up from Rs 130 crore in 2003-04. The Bt Cotton seeds sales only accounted for 76.75 percent of this market, bio pesticides, biofertilizers and markers accounted for the rest. International Panacea and Biotech International were the two major companies in the biopesticides and biofertilizers category. International Pancea reported sales of Rs 17 crore, while Biotech Biotech International's sales stood at Rs 10.64 crore. This year would be a watershed year for Bt Cotton. Bt cotton gets green signal in several other states. The apex regulatory body, the Genetic Engineering Approval Committee (GEAC), approved six new varieties of transgenic cotton in the northern states of Punjab, Haryana and Rajasthan. With this decision, transgenic cotton will now be commercially cultivated in the North for the first time. These approved genetically modified Bt cotton hybrids include MRC-6301 and MRC-6304 of the Jalna-based Maharashtra Hybrid Seeds Company (Mahyco), RCH-134 and RCH-138 of the Coimbatore-based Rasi Seeds and Ankur-651 and Ankur-2534 of the Nagpur-based Ankur Seeds. Spurious Bt Cotton Seeds in Gujarat. Central Institute of Cotton Research (CICR) verified the allegation of spurious Bt cotton seeds in Gujarat and found them to be positive for the presence of Cry 1 Ac gene. Here's the list. Brand Name Rakshak Virat Captain F-1 Hybrid Cotton Seeds Research Hybrid Cotton F-1 ( Tilak) Trishul ( F1) Kavach F-1 Hybrid Kapas â€“ 151 Suraksha â€“ Hybrid Cotton Seeds Research Hybrid Cotton F-1. Krushi-357 Sarthi Only three Bt cotton hybrids of Mahyco (Mech-162, Mech-184 and Mech-12) were given the approval in 2002. In 2003, it was only RCH-2, the Bt cotton variety of Rasi Seeds that was given the green signal for cultivation in Central and Southern India. This year things have taken a dramatic turn. The total tally of Bt cotton hybrids approved for cultivation has climbed up to 17. And these can be grown in the three zones. While the North zone includes Haryana, Punjab and Rajasthan, Central India includes Maharashtra, Gujarat, Madhya Pradesh and Chhattisgarh, South zone includes Andhra Pradesh, Karnataka and Tamil Nadu. Nuziveedu Seeds Ltd, which launched its Bt versions of its cotton hybrid varieties, Bunny and Mallika, announced that it has prepared about five lakh packets of Bt hybrid seed for cultivation in the kharif season. Of these, 1.2-1.5 lakh packets will be sold in Andhra Pradesh. The Bt seed pack, including the conventional seed, has been priced at Rs 1,820. Monsanto technology rules the roost. The Bt cottonseeds, originally developed by Monsanto in the US and marketed under the brand name of "Bollgard", is being marketed by the joint venture company Mahyco Monsanto Biotech India Ltd. The company has transferred the Bt technology to over 15 Indian seed companies like Rasi, Ankur, Emergent Genetics, Ajeet, JK Seeds, Krishi Dhan, Vikram Seeds, and Tulsi Seeds. The trials conducted by these seed companies are at different stages. Each of these companies pay Monsanto about Rs 1200 per packet as royalty. BT Cotton Varieties Company Approved Bt Ankur Seeds Ankur-09 Ankur Seeds Ankur-2534 Ankur Seeds Ankur-651 Mahyco-Monsanto Mech-12 Bt Mahyco-Monsanto Mech-162 Bt Mahyco-Monsanto Mech-184 Bt * Mahyco-Monsanto MRC-6301 Mahyco-Monsanto MRC-6304 Mahyco-Monsanto MRC-6322 Mahyco-Monsanto MRC-6918 Nuziveedu Seeds NCS-145 Bunny Bt Nuziveedu Seeds NCS-207 Malika Bt Rasi Seeds RCH-118 Rasi Seeds RCH-134 Rasi Seeds RCH-138 Rasi Seeds RCH-144 Rasi Seeds RCH-2 Rasi Seeds RCH-20 Rasi Seeds RCH-317 Rasi Seeds RCH-368 Indigenous technology and technology from Sygenta are also being considered. Companies like Indo American Hybrid Seeds and Metahelix are working on this front. Moreover, Metahelix is getting ready with its own Bt Cotton. In October 2003, National Botanical Research Institute (NBRI), Lucknow, announced that its technology was ready for transfer and also licensed the same to a consortium, Swarna Bharat Biotechnics Pvt Ltd (SBBPL), for transfer. The indigenous Bt technology and its likely commercialization in the current regulatory system are likely to happen in 2007-2008. The regulatory system has been on an evolution path. The regulatory system is unable to do anything about the spread of the illegal Bt cotton, which is spreading at an unabated and alarming rate. The illegal Bt cotton occupies more area (about 25 percent of total hybrid cotton area) than the legal version (about 10 percent of total hybrid cotton area) according to some reports. It is widely felt that deregulation of transgenic technologies like Bt cotton (Cry1 A(c) gene in cotton) where bio-safety is proven and approved for commercial use, as it is the case in countries like the US and Australia, is the solution for several of the regulatory problems with transgenic crops like Bt cotton in India. With the National Biotech Policy in sight, most of them are hopeful that things will change. And 2006 would be a landmark year for Bt cotton. ]]> <![CDATA[A Threshold Crossed]]> https://biospectrumindia.com/news/95/2904/a-threshold-crossed.html https://biospectrumindia.com/news/95/2904/a-threshold-crossed.html Mon, 13 Jun 2005 10:42:00 +0530 Last year, the 2nd annual BioSpectrum-ABLE industry survey surmised that the Indian biotech industry was on the arrival mode. With the industry zooming past the $1 billion mark, registering revenues of Rs 4,745 crore ($1.07 billion), a threshold has been crossed. And one can say, it has now arrived. The biotech industry continued to grow at almost the same rate that it did in the previous fiscal despite a growing base. The industry recorded 36.55 percent growth compared to the previous year's revised figure of Rs 3,475 crore ($788 million). In 2003-04, there were just four companies with revenues in excess of Rs 100 crore. This year two more companies crossed this landmark. Interestingly, these are not the companies from the health care pharma biotech sector, which so far occupied the top five positions. Venkateshwara Hatcheries is an animal health care company and Mahyco-Monsanto Biotech is an agribiotech company. This is yet another reason to say that a threshold has been crossed. Top Companies A comparison of the composition of the top five companies reveals this. The market leader, Biocon is an integrated biotech company with interests in discovery, biopharmaceuticals, and enzymes. Serum Institute of India and Panacea Biotec follow it respectively with biotech sales of Rs 565 crore and Rs 217.19 crore. These two are homegrown vaccines manufacturers of international repute. The fourth in the ranking, Venkateshwara Hatcheries is a leading poultry vaccines manufacturer, which registered a record growth of 113.64 percent to end the year with a business of Rs 118 crore. This company is now expanding into the human health care market. Mahyco-Monsanto Biotech, a JV between India's leading seed company Mahyco and bioagri leader Monsanto, is a bioagri company, which registered record sales of Rs 166.40 crore. These five are a representation of the different type of biotech companies. Biotech Industry in 2004-05 Segment Revenues (in Rs crore)   Market Share (%) Growth (%) 2003-04 2004-05 2003-04 2004-05   BioPharma 2752 3570 79.19 75.24 29.72 BioServices 275 425 7.91 8.96 54.55 BioAgri 130 330 3.74 6.95 153.85 BioIndustrial 238 320 6.85 6.74 34.45 Bioinformatics 80 100 2.3 2.11 25 Total Industry Size 3475 4745 100 100 36.55 BioPharma corners three-fourths of Indian market($811 million out of $1070 million) Further down the ranking, Novo Nordisk, the #6 company, is a global major, which has direct presence in India and it is the leader in the human insulin market here and is basically a therapeutics player. Rasi Seeds at the seventh position is an Indian agri company, which sourced the technology from Monsanto. Aventis Pharma, Bharat Serums and Chiron Behring Vaccines, ranked eight, nine, and 10 respectively, are into the human health care segment. Homegrown Companies It may be noted that this year's table of Top 20 Biotech companies does not include the diagnostics and bioservices companies. This was a conscious decision taken to evolve true list of biotech companies, as is the global practice. Also this year, we have created a list of Top 20 Homegrown companies. This is a list to track how Indian entrepreneur-led biotech companies are performing in the market place. While the top 20 companies of the "Top 20 Biotech" list have recorded total sales of Rs 2,843 crore, the "Top 20 Homegrown" companies registered total sales of Rs 2,479 crore. Top20 Biotech Companies Rank Company  Biotech Turnover (Rs Crore) Growth (%age) 2003-04 2004-05 1 Biocon 502 646.36 28.76 2 Serum Institute of India 550 565 2.73 3 Panacea Biotec 149 217.29 45.83 4 Venkateshwara Hatcheries 88 188 113.64 5 Mahyco Monsanto 54 166.4 208.15 6 Novo Nordisk 110 135 22.73 7 Rasi Seeds - 86.87 - 8 Aventis Pharma 73 84.3 15.48 9 Bharat Serums 79.68 81 1.66 10 Chiron Behring Vaccines 67 78 16.42 11 GlaxoSmithKline 61 77.82 27.57 12 Indian Immunologicals 56.69 72.38 27.68 13 Shantha Biotechnics 40 70 75 14 Novozymes 53 69 30.19 15 Eli Lilly and Company 67.4 68.38 1.45 16 Wockhardt 40 67 67.5 17 Bharat Immunological & Biological Corp. 21.59 53.25 146.64 18 Bharat Biotech International 36 41 13.89 19 Advanced Biochemicals 30.1 39.55 31.4 20 Biological E 38.37 36.25 -5.53   Total Top 20 Revenues 2116.83 2842.85 34.3 While the Top 20 Biotech companies registered a growth of close to 34 percent, the homegrown companies too were not far either. They registered a total growth of 35.6 percent in 2004-05. The Top 20 Biotech companies in 2004-05 accounted for close to 60 percent of the total biotech market of Rs 4,745 crore. Compared to that figure, the Homegrown companies contributed 52 percent of the total biotech business in 2004-05. The top five list of "Top Homegrown" companies and "Top 20 Biotech" companies remained the same. A clear trend is that the homegrown companies are maturing and consolidating their global positions too. The next five in the homegrown list were Rasi Seeds, Bharat Serums, Indian Immunologicals, Shantha Biotechnics and Wockhardt. Again this list represents the presence of the companies in various sectors. The top five companies accounted for 33 percent of the total market of Rs 4,745 crore in both categories. While the Top 10 homegrown companies accounted for 43 percent of the market share, the Top 10 biotech companies in the country accounted for 47 percent of the total biotech business. Segments Performance BioPharma is the single largest contributor to the total business. This sector with total sales revenues of Rs 3,570 crore ($811 million) accounted for more than 75 percent of the total business. BioPharma registered close to 30 percent growth, primarily driven by the vaccines business. The BioServices sector is the next big market with nearly 9 percent market share. The BioServices market is estimated to be Rs 425 crore in 2004-05, recording close to 54.6 percent growth. With the two Bt cotton companies, Mahyco-Monsanto and Rasi Seeds, in 2004-05 the BioAgri sector was the fastest growth sector, though it accounted for only 6.95 percent share of the total market. This sector grew nearly by 154 percent to Rs 330 crore. BioIndustrial sector generated total revenues of Rs 320 crore, registering 34.45 percent growth. It accounted for 6.74 percent of the total market. Bioinformatics sector registered 25 percent growth to record total business of Rs 100 crore and accounted for 2.11 percent of the market. Exports Vs Domestic Sales The total biotech exports from the country stood at Rs 2,001 crore and contributed to 42.17 percent of the total biotech business. The domestic business accounted for Rs 2,744 crore. The BioPharma sector accounted for the largest share of exports with total revenues of Rs 1,463.7 crore and accounted for 73.15 percent of the total exports. The next big contributor was the BioServices segment with total exports of Rs 391 crore. It accounted for 19.54 percent of the total exports. Among the other segments, Bioinformatics contributed 3.6 percent, BioIndustrial 2.56 percent, and BioAgri 1.15 percent to the total exports of Rs 2001 crore. The domestic business was mainly driven by BioPharma sales. BioPharma accounted for 73.15 percent share of the total domestic biotech business of Rs 2,744 crore ($623 million). BioPharma's contribution was Rs 2,106.3 crore in 2004-05. BioAgri was the next big contributor with total domestic sales of Rs 306.9 crore and accounted for 11.18 percent of the Rs 2,744 crore domestic biotech business. BioIndustrial's share of the business was 9.8 percent and it generated Rs 268.8 crore sales. Bioinformatics and BioServices are yet small markets for domestic business and they accounted for 1 and 1.24 percent share of the total pie. SURVEY & RANKING METHODOLOGY BioSpectrum conducted this survey in association with the Association of Biotechnology Led Enterprises (ABLE). BioSpectrum and ABLE have jointly been doing this exercise since 2003. A detailed questionnaire (survey form) is sent to over 450 companies to capture the needed information for the analysis. This was done during April-May 2005 and the forms were collected till 25 May. Over 200 companies shared information with us to the extent it was possible about their companies and the industry. Over 90 percent of the companies are in the private sector and unlisted, yet they shared financial information for this survey. The information provided by the companies was crosschecked before publishing this report. NOTES The revenues considered for the analysis are biotech products sales and service figures. In several cases where revenue figures were not available estimates were made based on diverse industry inputs. This year in the list of Top 20 Biotech companies, diagnostics and services have not been taken into account. Biotech suppliers' revenues have not been considered as part of the biotech industry definition. BioPharma included products made by fermentation/animal cell culture (not animal extracts) and plant cell culture (not plant extracts). The Agri segment analysis has included only the GM seeds and molecular markers and related products. So the hybrid seeds business is not a part of the agribusiness sales values.  For all the ranking purposes, we have taken the biotech business only into consideration. Wherever TURNOVER is mentioned it means, sales turnover from biotech. That means it is not necessarily the total sales turnover of the company. Women form a significant part of the workforce in research-intensive companies. They account for nearly 30 percent of the employees in this sector. However, biotech companies, which are primarily sales and marketing driven, are exceptions to the general trend of biotech companies having more women employees. Many of these companies are keen to induct women even in marketing, sales and technical functions, which require extensive traveling. In "How the Regions Fare" table, the figures mentioned are the revenues generated by the companies based in that respective region and not the sales done in that region. As the East has very little base, we have included the same in North. The BioSuppliers segment grew by 42 percent to Rs 1230 crore( $280 million), clearly indicating the continuing investments made by the biotech companies in the country. Indian Bioclusters The industry is well spread across the country. Several states have biotech policies and also biotech parks to promote the industry. The biocluster in the Western region is the largest in terms of revenues generated. The industry comprises over 280 companies that are into biotech business and another 120 that supply technology products to these biotech companies. The southern cluster is housed in Bangalore, Hyderabad, and Chennai. The West is centered around Aurangabad, Ahmedabad, Mumbai, and Pune. Companies in the North are primarily located in Delhi-Gurgaon-Noida region. Bangalore is home to the country's largest biotech group Biocon and global companies like Accelrys, Astra Zenica and Monsanto have set up their research centers in the city. The heterogeneous nature of the cluster, which has companies ranging from bioagri to bioinformatics to bioindustrial, also makes it an attractive destination for companies to set up shop here. Avesthagen, for example, works in diverse areas from nutraceuticals to agri research. Today most of the biotech companies want to harness the prowess of IT to develop products and Bangalore, a global IT hub, makes it a natural choice. Bangalore has also demonstrated several successful collaborative partnerships. And entrepreneurial culture is highly prevalent here. That is the reason for seeing several start-ups. Strand Genomics, xCyton, Metahelix, Molecular Connections and Gangagen are a few examples. A proactive and supportive state government is an attraction for investors. This is the reason why Bangalore has attracted several companies in past few years. ReaMetrix, MWG Biotech, Cancer Genetics, ClinWorld, ClinTec and Jubilant Biosys are just a few examples. Bangalore is a global brand; It has a strong technology culture; it has several R&D establishments like NCBS and IISc. and Astra Zeneca to leverage upon. Bangalore will have a Biotech Park by the end of next year. Hyderabad is another important destination in South. A strong pharma base and presence of mature biotech manufacturers like Indian Immunologicals, Shantha Biotechnics, Bharat Biotech, Dr Reddy's and Biological E make it a strong hub. Also has a strong representation in bioagri sector with companies like Emergent Genetics, JK Agri Genetics, and Nuziveedu Seeds. Hyderabad already has established biotech parks-ICICI Knowledge Park and Shapoorji Pallonji Biotech Park to provide the ambience. The state government is business friendly and has actively pursued the cause of the biotech industry. It also created India's first biotech venture fund APIDC. Leading research institutes like CCMB, CDFDRI and IICT provide the right scientific atmosphere. In the West, Mumbai is home to some of the leading global biotech players like GlaxoSmithKline, Aventis and Pfizer. Serum, the second largest biotech group in the country, is established in Pune along with Venkateshwara Hatcheries. Also other leading pharmaceutical companies in the country like Wockhardt, Nicholas and Intas have their base in Maharashtra and Gujarat. In terms of the biotech revenues generated by the companies based in the regions (not the sales done in that region), West accounts for the biggest chunk of the market. Led by Serum Institute of India, Venkateshwara Hatcheries, and Mahyco-Monsanto, the region accounted for 50.8 percent of the total biotech business generated. West's contribution was Rs 2,412.36 crore. South's share in the pie was 40.01 percent and Biocon along with Rasi Seeds led the way. The business of South headquartered companies was Rs 1,898.47 crore. North with total business of Rs 434.17 crore accounted for 9.15 percent share of the market. Panacea and Eli Lilly are the two major players from this region. ]]> <![CDATA["Continuous Industry-Academia Interaction Is The Need of The Hour" -Dr Smita S Singhania]]> https://biospectrumindia.com/news/95/1314/continuous-industry-academia-interaction-is-the-need-of-the-hour-dr-smita-s-singhania.html https://biospectrumindia.com/news/95/1314/continuous-industry-academia-interaction-is-the-need-of-the-hour-dr-smita-s-singhania.html Wed, 11 May 2005 18:31:00 +0530 The University of Pune start ed an innovative and novel program, MBA-Bio technology and post 10+2, five years integrated MSc/MTech. biotechnology, BE/BTech., ME biotechnology programs. The list of institutes, universities, colleges offering variety of different courses under the discipline of biotechnology was published in the students special of BioSpectrum December 2004 issue. One of the pioneer universities in the field of biotechnology and to be regarded as the 'Oxford of the East' by scholars from across the globe is the University of Pune. With the efforts of vice chancellor Prof Ashok Kolaskar and his team of stalwarts from academia and industry, the University of Pune has received five star rating from the National Assessment and Accreditation Council (NAAC). The University Grants Commission (UGC) also recognized the University of Pune as a University of Potential Excellence in cutting edge areas of biotechnology and bioinformatics. The university's major teaching and research programs have secured the support of several agencies of national repute such as the DST, DBT, CSIR, DAE, and the DRDO. It offers various teaching programs in biotechnology - undergraduate programs like BSc (Vidya Pratisthan, Baramati's efforts are commendable) and BE/BTech. in various affiliated colleges, MSc biotechnology (entrance exam by JNU) and integrated MSc/ MTech. biotechnology (entrance examination conducted by the Institute of Bioinformatics & Biotechnology/ MKCL) in the campus, PhD biotechnology in postgraduate teaching department and various affiliated national level research institutes and industry R&D centers (entrance examination by the University of Pune), advanced diploma in bioinformatics, MSc.-bioinformatics (entrance exam conducted by Bioinformatics Center, UOP). The MBA-Biotechnology program (started from 2002, with intake of 60 students) is conducted by the Department of Management Sciences (PUMBA), University of Pune. The entrance examination pattern is similar to any MBA entrance examination - written test conducted by Association of Indian Management Schools (AIMS) and Test for Management Admissions (ATMA) and group discussion and personal interview conducted by PUMBA. For further details, candidates can visit the website http://www.unipune.ernet.in. The MBA-Biotechnology Program of the University of Pune gives exposure to subjects like regulatory matters, IPR and bio-enterprise management, BT Plant Management, Biosafety issues, GMP, GLP, Validation, QA/ QC, emerging trends in biotechnology, and short term training in biotechnology units. The popularity of these programs run by the University of Pune in academia, industry and students is mainly because of the updated course curriculum by academia and industry which meets the expectations marked by stalwarts of biotechnology in various issues of BioSpectrum and also mentioned in the National Biotechnology Development Strategy. Even regular interaction between faculty and students help the later to updating themselves about the current and emerging issues in biotechnology. Attending national and international seminars, conferences, biotechnology unit visits and interactions with global stalwarts of industry and academia also help them to know the needs of the industry. The success of all these efforts is evident in biotechnology units as companies like the Serum Institute of India, Biocon Ltd, Reliance life Sciences, Nicholas Piramal, Mahyco, Avesthagen, Quintiles, Wockhardt, Multiplex, Millipore, SRL Ranbaxy, Sanmar, Sartorius, SPAN Diagnostics, Praj Industries, Torrent Pharma, GSK, Vital Biological, Bio-Rad, Biotech India, Hysel India, Sigma Aldrich, Eli Lilly, Carl Zeiss, Frost & Sullivan, Life Technologies, SPIC-Mitocon, Transearch, Olympus India Ltd, DSS, Novartis India, Syngenta, Seminis Vegetable Seeds, to name a few offer an opportunity for students to work with them. This is the ultimate goal of each and every student who takes up biotechnology as a career option. Continuous interaction between academia and industry is the need of the hour as it helps both in fulfilling the needs of the industry and at the same time realizing the dreams of the student community. Dr Smita S Singhania, faculty & course co-ordinator, MBA-BT, Department of Management Sciences, University of Pune. ]]> <![CDATA[UK: Biotech Training With A Cutting Edge]]> https://biospectrumindia.com/news/95/2396/uk-biotech-training-with-a-cutting-edge.html https://biospectrumindia.com/news/95/2396/uk-biotech-training-with-a-cutting-edge.html Wed, 11 May 2005 18:30:00 +0530 The United Kingdom ranks high among students as an attractive destination for higher studies. The UK has a long history of quality education and the intellectual stimulating environment at its colleges makes it the preferred choice for many. A lot of Indian students study in the UK. An indication of this is the MSc Biotechnology and Bioinformatics course offered by the Abertay Dundee University. Last year, out of the 65 students in the course, about 58 were from India! Course Structure Undergraduate level The undergraduate courses in biotechnology and related subjects in the UK are a recent trend. Many of these courses started about six years ago and were developed as a comprehensive module suiting the requirements of the industry. The course duration is three or four years and the academic session starts from October. The first year is generally an introduction to a whole range of subjects. While during the second and third years, the students combine various subjects based on what interest they have to make up the final degree. The program is structured in such a way that it allows the student to delay the ultimate choice of specialization until the second year and to switch between areas of biological, medical or biotechnological science if the interests change. The universities offer a high degree of flexibility and the study programs are modular with a wide range of options in the latter stages of the degree. These choices build on the core knowledge and skills developed through year one and two. There are undergraduate honors degree programs in biological sciences, biochemistry, human biology, bioinformatics, biotechnology and other related disciplines. The general aim of the undergraduate course is to equip the graduates to pursue higher degrees focused on research or more vocational courses like an MSc. Typically most of the universities provide an option of choosing from a three-year BSc honors course or a four year BSc honors course. The four-year course is also known as a "sandwich" course, with a year of study overseas or industry experience. Generally the university has tie- ups/links with some institutions abroad. For instance, the University of Birmingham has tie-ups with France, Germany and Spain. Most often after the first and second year of study in the university, the third year is spent abroad in a foreign university or in the industry and for the final year of studies, the student returns to the parent university. The experience of working in the industry as a professional during the course of the degree also helps in defining the career objectives. Most of the universities have extensive links with companies and organizations in diverse fields from the pharmaceutical industry to medical research. For example, the University of Birminghan has tie-ups with companies like GlaxoSmithKline, AstraZeneca, Celltech, Cambridge Antibody Technology, Novartis among others for the one year professional placement of students. Postgraduate level The MSc courses are focused specialized educational programs leading to a degree in biotech or related specialized areas. Typically at a postgraduate level most of the universities offer a Masters degree, and also diploma and certificated short-course training programs in the same specialization. The Masters degree program generally runs for twelve months. The first eight months are divided into two semesters of course work, followed by a four-month research project. The taught modules within each semester are self-contained and are also available as independent short courses. The diploma and short courses are designed to provide in-service, refresher or introductory training for those already in the industry. Some universities offer a Research Masters (Mres) course, which looks at the possibility of spending 50 percent of the time undertaking a research project and 50 percent on course work. Such one-year programs provide an innovative mix of the appropriate theoretical background with research experience for those wishing to gain employment in associated research fields. Research Training Most of the universities offer research training at MPhil or PhD levels in various areas of research depending on the areas in which they specialize - Molecular Cell Biology, Molecular Microbiology, Molecular Pathobiology, Organismal and Environmental Biology, Plant Genetics and Cell Biology, Structural Biology and many others. Generally the universities offer an option to students who have performed well in their MSc degree research project to continue their research for a PhD and so complete the MSc and PhD training in three years. The MPhil degrees are two-year courses either run independently or in association with other universities. Gaining Entry UG level Most UK institutions accept the Indian school leaving qualifications (especially from the two main national boards: The Central Board of Secondary Education and the Council for the Indian School Certificate Examinations) for admission to undergraduate courses. The state boards are considered on a case-to-case basis. Applicants have to meet the minimum marks requirements and this varies from institution to institution. Competitive institutions generally expect a much higher percentage of marks. The institutions also consider other factors such as extra-curricular activities, relevant part-time work experience and the quality of the application. The personal statement and the reference from the principal/teacher are also very crucial! "A big percentage of foreign students take up higher studies in UK" George Abraham, Marketing Director, Warnborough University, Canterbury, Kent, UK shares his views about biotechnology education in UK from the perspective of international students. What are the different courses offered in the UK? There is a broad selection of courses at the undergraduate level with many options depending on the strength of the universities and other departments that can support developing new programs. The courses gets more specialized at the postgraduate and PhD levels. Typically biotechnology being offered as a subject area is only about 3-5 years old at the first-degree level, but it has been available at both postgraduate and PhD levels much longer, though it was not 'branded' as biotech! How are the courses structured in the UK? Normally at the first degree level courses are for 3 years and in some cases 4 years. In the latter scenario the student have a chance to either transfer to work within industry or study at another foreign university for a year typically USA/Germany/Australia/ Singapore/Sweden depending on mutual agreements signed. The study transfer is done in the second year whereas the work experience is carried out in the third year of study. Transfer credits for courses are accepted to the 'mother ' campus of the student. This is usually only available with the big universities in the UK and possibly with a few 'younger' universities. What are the different scholarships/fellowships available? This will vary according to courses, universities and demand and this can vary from year to year. Foreign students however can apply for them, if applicable, at the time of submission of their application. This must be done early. Other possibilities are scholarships from British Council, Commonwealth focused scholarships for countries and there may be some for India and company funded assistantships. At the Master's and PhD level most students get some sort of financial support through teaching and other research grants. This is the greatest opportunity for foreign students to get scholarships, especially Indians, as the biggest percentages of students taking up higher level studies are non UK candidates. How can one enroll for courses in the UK? For undergraduate level (first degree) admissions are processed through UCAS, which is a central admission system operated in the UK for all universities and colleges. For postgraduate and PhD level it is done directly with the university concerned. Please elaborate on courses offered by your institute. We at Warnborough only offer biotech related programs at the PhD levels. The focus is slightly different than the traditional PhDs. We do not have extensive laboratories focused approach that is the fundamental research type PhD. Most of the students doing a PhD at the institute will be doing comparative research in the broad 'arena' called biotech. For example we had a student who completed a PhD in Neuro-pharmacology with us and is now an Assistant Professor at the University of Kansas Medical Centre, USA focusing on Parkinson's disease and Occupational Therapy. Another area of PhD research studies at Warnborough is the Advanced Research Centre for Comparative Bioethics (ARCCB). This Centre focuses on research related to the fast developing issues around new found cures, medical procedures, 'green' economics, environmental impact etc which are a direct result of the leaps made in the biotechnology space. Rolly Dureha The Universities and Colleges Admission Service (UCAS) co-ordinates applications for undergraduate courses in the UK. Which means that a student only needs to fill up one UCAS application form and can apply for a maximum of six courses. The student needs to send the completed form to UCAS, which will forward it to the institutions concerned. There is an option of applying online through 'International Apply' too. The deadline for UCAS application to University of Oxford and Cambridge is October 15, and for other applications is January 15. All applications received after June 30 are put into clearing. Another important criterion for study in UK is that all students need to show that they have an adequate knowledge of written and spoken English. In the case of international students this usually means taking either an IELTS or TOEFL test. PG level Most institutions normally require an equivalent to a British first degree in a relevant subject for entry to a postgraduate diploma or Masters degree. The personal statement and references with the application form are very important in the admission process. For research courses, institutions will look for an outstanding academic record. The student will have to submit a research proposal and have a good masters degree. There is no centralized system of applications for postgraduate courses in the UK. Each institution has its own application form, which would be available from the institution or their website. There are no deadlines for most postgraduate courses in the UK. However, a few institutions may have application deadlines. So it is best to confirm this from their website or prospectus. Scholarships Studies in the UK could be expensive and it would benefit students to go for scholarships and grants. The British government and other UK organizations provide a number of scholarships and awards to help international students. The applications for grants should be made at least one year before the course applied for commences. A majority of the grant-making bodies give a partial grant, which is usually not enough to cover the full cost of a course. The scholarships available for Indian students are as follows: British Chevening Scholarships The Chevening (India) Program offers up to 120 annual awards for Indian nationals. The grants are given for one-year masters and short-term professional programs. A university degree or equivalent qualification is a must, along with relevant work experience in case of professional programs. For details, visit www.britishcouncil.org.in/scholarships. The CommonwealthScholarship/Fellowships Plan UK offers up to 55 annual scholarships and upto 70 academic staff fellowships for Indians. The scholarships are for one-year masters, three-year doctoral or one-year clinical training awards in specific subjects. A university degree or equivalent qualification is a prerequisite. Grants are for one to three years and usually cover the cost of travel, tuition fees and living expenses. DFID Shared Scholarship Scheme This scheme assists academically able students from developing Commonwealth countries who would benefit from higher education in Britain to the developmental advantage of their home countries, but for financial reasons are unable to study in the UK and are outside the scope of other British government support schemes. Awards are for postgraduate courses. For details, visit www.acu.ac.uk Overseas Research Students Awards Scheme (ORSAS) These grants are for postgraduate students undertaking full-time study for a higher degree as registered research students at British universities. Selection of candidates is based solely on academic merit and research potential. The scheme supports approximately 800-850 new awards each year in the UK. For further details, visit www.universitiesuk.ac.uk/ors/. Royal Society Fellowships The Royal Society runs a scheme of research appointments within the UK and a series of programmes encouraging exchanges of information, dialogue and visits overseas. These fellowships enable key post-doctoral scientists from a selection of countries to undertake research in the UK. Some other scholarships available are Inlaks (www.inlaksfoundation.org), Rhodes (www.rhodesscholarship-india.com), Scottish Executive (www.scotlandscholarship.com). Some of the universities also offer scholarships for international students. Tie-ups between Indian and UK Institutes The increased interest between the two countries has led to some academic partnerships between universities of the two countries. The University of Central Lancashire currently has a partnership with DY Patil Mahavidyapeeth, Nerul, Navi Mumbai. Students do part of the BSc (Hons) Biomedical degree program in India and the balance in the UK at the University of Central Lancashire. The first batch had 14 students and the second batch had approximately 40 students. Further details can be obtained from D Y Patil Vidyapeeth, Vidyanagar, Nerul, Navi Mumbai. The University of Abertay, Dundee is also exploring partnershipsX biotechnology with a few institutions in India. Thus, the UK provides a wide range of flexible opportunities for higher studies beckoning the Indian student fraternity. Rolly Dureha   ]]> <![CDATA["Academic and workforce track are two models of biotech education in the US"]]> https://biospectrumindia.com/news/95/7739/academic-and-workforce-track-are-two-models-of-biotech-education-in-the-us.html https://biospectrumindia.com/news/95/7739/academic-and-workforce-track-are-two-models-of-biotech-education-in-the-us.html Wed, 11 May 2005 18:26:00 +0530 Dr Chandra Mittal, professor and associate chair, Department of Biotechnology, Houston Community College (HCC), shares his views about biotech education in the US. He can be reached at chandra.mittal@hccs.edu What are the models of biotech education offered in the US? There are two basic models of education in the field of biotechnology. These are academic-track emphasizing theoretic aspects of living systems, and the workforce-track dealing purely with the development of skilled manpower for the biotech industry. The workforce track emphasizes the training in hands-on technical skills. The American system lays emphasis on the differences in the goals and approaches for the two tracks. While the academic track, primarily represented by universities, educates people to enhance scholarly skills, the workforce track (primarily represented by the community colleges) is devoted to generate technical manpower for the industry. Training programs at the community colleges (CCs) are accredited by State agencies and are administered by the workforce deans. Since the CC programs focus on the needs of the local industry, these institutions work closely with the industry, and seek their active inputs and advice. Each of the workforce training programs are required to have an advisory committee which monitors the progress of the training programs and draws two-third of its members from the industry. To enroll in workforce training programs, one needs to have K-12 level education. What are the different biotech courses offered (at the graduate, postgraduate and PhD level)? What typically is their duration? And what are the prerequisites? The different types of biotech courses available in the United States include associate degree, bachelor's degree and graduate (MS and PhD) degree. The typical duration for associate and bachelor's degree is two and four years respectively, after high school (K-12). PhD takes about five years after BS degree. The associate degree in biotechnology requires prerequisite courses in biology, chemistry, algebra, computer applications, and English composition. Students with associate degree can also move on to universities and earn a bachelor's degree in biotechnology. Can you elaborate about the courses offered and mandate of the HCC? Since Houston is the world-renowned center for healthcare and energy sectors, HCC is an integral part of the community providing trained workforce in these areas. It has programs in biotechnology, health technologies, petroleum technology and biomedical engineering technology. The courses/degrees offered by HCC in these areas prepare the workforce for each sector. The key element of the training at HCC is the hand-on skill development and required practical training (internships) in the industry. This gives students the actual taste of the workplace. Our logo is "We make Houston work". Our main focus is four-fold - creating workforce at the technician level; corporate training where we cater to the development of certain niche skills; advanced certificates in different sub-sectors of biotechnology like bio-manufacturing and clinical research methodology, and to help small business in a collaborative manner by providing them the opportunity to incubate their ideas but all geared towards the industry. How can Indian students be oriented towards the needs of the biotech industry? Participation of the industry in the training program coupled with institutional flexibility to respond to the change in the industry is at the core of success of workforce program. I am not sure if there are institutions in India, which share this feature. But these are most certainly needed. Creating such training programs from scratch is likely to take a long time and finances. In the short term, partnership and collaboration with institutions like HCC is a viable option for India. This will help India jump-start things and also sensitize students to the needs of the industry. There would be dual benefits of going in for such a partnership. First of all biotech businesses are becoming global, so the trained manpower, whether it is from India and some other country, has to be on par with the existing international standards. Secondly, India is developing to be a global hub for products and services. HCC type programs would be ideally suited for students who have an undergraduate degree in India. Such collaborative relationships can help the Indian industry meet their workforce needs as well as provide employment opportunities. What are the different scholarships/ fellowships available? There are various mechanisms and provisions available to finance college education in the US. These include loans guaranteed by the Federal and State governments, which are offered at very flexible terms. Additionally, there are also grants from government, private foundations and industry. Are there any tie-ups with a counterpart Indian institute? Any agreements between the countries/universities? Some of the institutions from India have shown interests in creating collaborative relationships with US community colleges in the area of workforce training. A few years ago, several Indian states took part in an Indo-US conference on developing collaborations with the US community colleges. With the increase in business activity in India by the US corporations, such relationships are likely to grow in the future. Rolly Dureha ]]> <![CDATA[Educational loans a boon for students]]> https://biospectrumindia.com/news/95/2794/educational-loans-a-boon-for-students.html https://biospectrumindia.com/news/95/2794/educational-loans-a-boon-for-students.html Wed, 11 May 2005 18:13:00 +0530 The changing education scenario is pushing students to invest heavily on education, which their parents cannot afford. Taking educational loans is the lone solution for them to realize their dreams. Prior to independence, the growth of institutions of higher education in India was very slow and diversification in areas of studies was very limited. After independence, the number of institutions increased significantly. There are 214 universities and equivalent institutions including 116 general universities, 12 science and technology universities, 7 open universities, 33 agricultural universities, 5 women's universities, 11 language universities, and 11 medical universities. Besides, there are universities focusing on journalism, law, fine arts, social work, planning and architecture and other specialized studies. In addition, there are 9703 colleges where 80 percent of undergraduate and 50 percent of postgraduate education is imparted (as of October 1998). In spite of vast efforts over the last 50 years, it is only now that the country is slowly emerging out of the fetters of old ideas and rigid structures built during the colonial rule. There is at present a demand for radical changes, which have the potential to actualize a national system of education that was visualized during the freedom struggle. Banks offering loans Allahabad Bank Andhra Bank Bank of Baroda -BOB Scholar, Bank of India - Vidya Vardhini Bank of Maharashtra Canara Bank -Vidyasagar Loan Central Bank of India -Centvidhyarath Corporation Bank Dena Bank - Dena Vidya Laxmi Indian Bank Indian Overseas Bank - Vidya Jothi Oriental bank of Commerce Panjab and Sindh Bank Panjab National Bank â€“ Vidyalaksyapurti State Bank of India State Bank of Bikaner and Jaipur State Bank of Hyderabad State Bank of Indore State Bank of Mysore State Bank of Saurashatra State Bank of Travancore - Gyan Jyothi Syndicate Bank â€“ SyndVidya UCO Bank Union Bank of India United Bank of India Vijaya Bank Hence national and state level policies are framed to ensure that this basic need of the population is met through appropriate public and private sector initiatives. While government endeavor is on providing primary education to all on a universal basis, higher education is progressively moving into the domain of private sector. With a gradual reduction in government subsidies, higher education is getting more and more costly and hence the need for institutional funding in this area. In the recent years the scope of education has also widened both in India and abroad covering new courses in diversified areas like biotechnology, information technology and molecular biology. And development of human capital is a national priority and it should be the endeavor of all that no deserving student is denied opportunity to pursue higher education for want of financial support. Hence the Government of India in consultation with Reserve Bank of India (RBI) and Indian Banker's Association (IBA) has framed a Comprehensive Educational Loan Scheme to ensure that no deserving student in the country is deprived of higher education for want of finances. The RBI has issued guidelines in this regard to all commercial banks in the country. A large number of banks including private banks (ICICI, HDFC, HSBC) have already launched educational loan schemes. All the scheduled banks like Allahabad Bank, Andhra Bank, Bank of Maharashtra, Corporation Bank, Indian Bank, Oriental bank of Commerce, Punjab and Sindh Bank, State Bank of India, State Bank of Bikaner and Jaipur, State Bank of Hyderabad, UCO Bank, United Bank of India, Vijaya Bank, State Bank of Indore, Union Bank of India, State Bank of Mysore, State Bank of Saurashtra are offering educational loans to students under the Educational Loan Scheme, while some banks have coined different names for the same. To know more about the scheme visit: http://www.education.nic.in/htmlweb/circulars/eduloan.htm#banks. The new scheme covers all type of courses including professional courses in schools and colleges in India and abroad.   The salient features of the scheme include: The scheme envisages loans up to Rs.7.5 lakh for studies in India and up to Rs 15 lakh for studies abroad. For loans up to Rs 4 lakh, no collateral or margin is required and the interest rate is not to exceed the Prime Lending Rates (PLR). For loans above Rs 4 lakh, the interest rate will not exceed PLR plus 1 percent. The loans are to be repaid over a period of 5 to 7 years with provision of grace period of one year after completion of studies To encourage parents to take up education loans for their wards, the government has been offering some benefits under Income Tax Act. Repayment of an education loan is deductible under Section 80E of the Income Tax Act. The yearly limit for deduction is Rs 40,000 (for both the principal and the interest). It will be applicable only for loans taken for higher education - fulltime studies in any graduate or post-graduate, professional, and pure and applied science courses. The deduction will be available for a maximum of eight years starting from the day one starts repaying. In the changing scenario, students have to invest on education in terms of purchase of books/equipments/instruments /uniforms, purchase of computers â€“ essential for completion of the course, travel expenses/passage money for studies abroad, industrial visits, study tours, project work, thesis to get the best feel of the industry and also to compete successfully in the knowledge-based economy of the 21st century. Otherwise they will be left behind in the race of competition. And those who can afford to invest will overtake them. The educational loan schemes of various nationalized banks are humble contributions in boosting the confidence of the parents and also students to take up professional courses. By offering educational loans, banks are supporting the younger generation to build a self-reliant country, where the educated youth will be its most valuable asset. Briefly about educational loans Purpose: For payment of fees to school / college and for purchase of books, hostel fees, examination fees, etc. Eligibility Conditions: Need-based finance is permitted with a maximum of Rs 7.50 lakh for inland study and Rs 15 lakh for study abroad. Institutions offering courses should have approval of Central Government and State Government / University affiliation / AICTE / DOEACC, autonomous Institutions like IIT, IIM, etc. Job oriented courses are preferred. Margin: Upto Rs 4 lakh - Nil for both inland and foreign studies Above Rs 4 lakh - 5 percent for inland studies, 15 percent for studies abroad Security: Upto Rs 4 lakh -Joint documentation with parents/guardian. Above Rs 4 lakh and upto Rs 7.50 lakh, for meritorious students in respect of higher education/ Professional courses - Joint documentation with parents/guardian and/or satisfactory guarantee. Assignment of future income of the student For above Rs 4 lakh other than (ii) above - Joint documentation with parent/guardian, Collateral security of suitable value and/or co-obligation of third party having required networth with assignment of future income of the student. Disbursement - Directly to University/College/Hostel/book supplier/ etc. Credit Delivery - The loan can be availed from the branch nearest to the place of permanent domicile. Rate of Interest: (Subject to changes as advised by Bank / RBI from time to time) Upto Rs.4 lakh â€“ 10.75% Above Rs.4 lakh â€“ 11.75% Repayment Conditions - Loans are repayable in 5 to 7 years. Repayment of both principal and interest will start after one year after completion of the course or six months after getting employment, whichever is earlier. Interest will be charged on simple basis during the period of study / moratorium period. At the commencement of repayment, the accrued interest is added to the principal amount and Equated Monthly Installments (EMIs) fixed on total outstanding amount. After commencement of repayment, the benefit of simple interest would be discontinued. Source: Canara Bank   ]]> <![CDATA[Biotechnology Scholarships]]> https://biospectrumindia.com/news/95/3858/biotechnology-scholarships.html https://biospectrumindia.com/news/95/3858/biotechnology-scholarships.html Wed, 11 May 2005 18:12:00 +0530 The Department of Biotechnology has several programs for scholarships/fellowships at the post-graduate, doctorate and the post-doctorate level. DBT-JRF Program A new program for Junior Research Fellowship has been launched in 2004-05 to generate human resource at the doctorate level. This aims to fill the gap between the postgraduate teaching courses and the postdoctoral fellowship program. Under this, 43 research fellows have been selected from 24 universities/centers where DBT-supported postgraduate teaching courses are being run. Research fellowship (JRF/SRF) as per the DST/CSIR norms is provided for a period of three years in the beginning and may be extended upto the fifth year on yearly basis depending on the progress in the research project. A consumable grant of Rs 30,000 per fellow per annum is also provided. "I will call upon students to do PhDs. Doing them will never be an issue. The DBT has several scholarships." - Dr MK Bhan, secretary, DBT. This year 43 JRFs (Junior Research Fellow) were selected from 24 DBT-supported universities/institutions. In the draft National Biotechnology Development Strategy, the DBT has proposed to increase the PhD fellowships to 200 per annum. Post-doctoral fellowship program The restructured DBT post-doctoral fellowship program is being implemented through the Indian Institute of Science, Bangalore since April 2001. The selected fellows can opt to work in universities and R&D institutions of their choice. Under this program, post-doctoral fellowship of Rs 11,000 per PDF per month in the first year and Rs 11, 500/ per month in the second year and a contingency grant of Rs 50,000 per PDF per annum is provided for the period of two years. Every year a maximum of 75 PDFs can be selected in two batches. Selection is made by the expert committee constituted at the Indian Institute of Science, Bangalore. During 2004-05 56 PDFs were selected in two batches. Biotechnology Overseas Associateship The DBT has been pursuing the Biotechnology Overseas Assocaiteship program to facilitate the availability of skilled scientists in adequate number. The program provides an opportunity to scientists for conducting advanced research or undergoing specialized research training in overseas research institutions/ laboratories in the priority areas of biotechnology. The overseas associateship is awarded under two categories namely long term (for a period of one year) and short term (for a period of 3-6 months). Biology Scholarships The DBT provides biology scholarships to the top students in biology at the CBSE 10+2 level examination. Each scholarship award comprises a cash prize of Rs 15,000, a gold-plated medal and a certificate of merit. Every year 25 scholarships are awarded. Selection of the 25 students is made from the merit list provided by the CBSE who are pursuing higher education in biology or related subjects after 10+2. Junior Research Fellowships Besides the scholarships offered by the DBT, the Council for Scientific and Industrial Research holds national level joint CSIR-UGC Examination (NET) normally twice every year, one in June and another in December. This examination determines the eligibility of Indian nationals for the award of Junior Research Fellowships (JRF) in science including biotechnology. Many of the state universities also offer scholarships/assistantship to students. Pact with TWAS The DBT has entered into an agreement with Third World Academy of Sciences (TWAS) to provide 50 fellowships annually in biotechnology for doctorate and post-doctorate studies to students from developing countries. ]]> <![CDATA[Biotech Education Abroad]]> https://biospectrumindia.com/news/95/2798/biotech-education-abroad.html https://biospectrumindia.com/news/95/2798/biotech-education-abroad.html Wed, 11 May 2005 18:09:00 +0530 Besides the US and the UK, Australia and Singapore have emerged as alternative attractive destinations for higher education in biotechnology. An overview of these two hubs from the perspective of a foreign student. Australia High On Biotech Education Australia is one of the top three destinations for international students. The country is a leader in biotechnology education and research. New biotech coursework gets implemented each year keeping the students, researchers and other personnel in the forefront of biotechnology innovation. It boasts of a strong entrepreneurial culture as almost 70 percent of Australia's biotech companies have been developed as spin-offs from university research. Australian universities offering biotechnology education Curtin University of Technology Deakin University Edith Cowan University Flinders University Griffith University James Cook University La Trobe University Macquarie University Monash University Murdoch University Queensland University of Technology RMIT University Southern Cross University Swinburne University of Technology The Australian National University The University of Melbourne The University of Newcastle University of New South Wales The University of South Australia University of Tasmania University of Western Australia The University of Western Sydney Victoria University The University of Southern Queensland (USQ) Biotechnology in Australia's universities is supported by investment from government and industry. Biotech is integral to the four priority areas for innovation nominated by the Australian government: nano-materials and bio-materials; genome/phenome research; complex/intelligent systems; and photon science and technology. The Australian government support includes various programs under Backing Australia's Ability - a five-year $2.9 billion innovation action plan launched in 2001. Australia has 37 government-funded universities and two private universities, as well as a number of specialist institutions providing approved courses at the higher education level. The universities engage in teaching and research across a wide range of professional and academic disciplines. As many as 29 Australian universities provide courses in biotechnology - The Australian National University, Curtin University of Technology, Deakin University, Edith Cowan University and Flinders University are a few such universities. Australian universities are increasingly providing unique specializations to ensure that personnel and students stay abreast of biotechnology, as many new fields emerge (eg: bioinformatics, proteomics) and as each new technology leads to new capabilities and new issues (eg: bio-security, stem cell research). The undergraduate courses have a duration of three years and most of the courses start in February. A few courses begin in July and October. Applications to study at Australian institutions can be made directly to the institution. The scholarships available for international students are, however, offered for postgraduate study in the universities. Partnership with India Australia's University of Queensland is strengthening Australia's links with India by establishing biotechnology research and student exchange ties with two of India's premier universities. A research collaboration agreement has been signed between the university and Manipal University of Higher Education (MAHE) and this agreement comes as the university hosts two Indian students under a student exchange program signed in 2003 with the JNU. Singapore: Hub of Biomedical Sciences In Singapore, biomedical sciences has been identified as the fourth pillar of the economy. There has been an all-round thrust for the development of this segment both from the industry and skilled human resources generation perspective. In 2004 major changes have been effected in the infrastructure of the educational system, especially in the way science education is imparted. The entire system is focused on empowering the students to take initiative and aims at making them more inquisitive. Presently, foreign students make up over 10 per cent of undergraduates and the Ministry of Education plans to raise it to 20 percent. There are three local universities - The National University of Singapore (NUS), Nanyang Technological University (NTU) and Singapore Management University (SMU). In accordance with the focus on biotechnology and biomedical sciences, NTU, which was set in 1981 to provide facilities for tertiary education and research in engineering and technology, created a new department of biological sciences in 2001. This school aims to provide students with a high quality university education and training in the life sciences. It offers a four-year, full-time BSc (Honors) course in biological sciences beginning with the new academic session in July. The graduate programs at NTU lead to masters and doctor of philosophy degrees and postgraduate diplomas. It has developed niche areas in research in the field of biomedical engineering. The NUS, a comprehensive university which offers courses in major disciplines, is expanding and focusing on the life sciences as well as consolidating interdisciplinary research. It offers degree and postgraduate programs in science and engineering. The university has several advanced training and research institutes including the Institute of Molecular and Cell Biology, Institute of Molecular Agrobiology, Institute of Engineering Science, Institute of Materials Research and Engineering. In addition to local universities, leading international universities have increased the level and scope of tertiary education in Singapore. Some leading international universities, which have collaborated with local institutions to launch their presence in Singapore include Georgia Institute of Technology - The Logistics Institute, Asia Pacific, Johns Hopkins University - Johns Hopkins Singapore, Massachusetts Institute of Technology (MIT) - Singapore MIT Alliance, Shanghai Jiao Tong University, Stanford University - Singapore Stanford Partnership, Wharton School of the University of Pennsylvania - Wharton SMU Research Centre and the Technische Universitat Munchen - German Institute of Science and Technology. BioPolis, the biomedical research hub of Singapore has 12 A*STAR (Agency for Science, Technology And Research), like the BioInformatics Institute (BII), the Bioprocessing Technology Institute (BTI), the Genome Institute of Singapore (GIS), the Institute of Molecular and Cell Biology (IMCB) and the Institute of Bioengineering & Nanotechnology (IBN), which conduct training programs in association with the universities. The academic year generally commences in July/August and comprises two semesters, each lasting for 16 or 17 weeks. For admissions, applications should be sent directly to the educational institutions accompanied by the relevant certification and documentation. Foreign students admitted to science courses at the local universities have to pay about S$6,000 per year as fees. The rest of it can be covered through grants given by the Ministry of Education. Rolly Dureha ]]> <![CDATA["TDB's role encompasses that of a venture capitalist and a financial institution but is still broader in scope"]]> https://biospectrumindia.com/news/95/4552/tdbs-role-encompasses-that-of-a-venture-capitalist-and-a-financial-institution-but-is-still-broader-in-scope.html https://biospectrumindia.com/news/95/4552/tdbs-role-encompasses-that-of-a-venture-capitalist-and-a-financial-institution-but-is-still-broader-in-scope.html Tue, 10 May 2005 15:16:00 +0530 In a chat with with BioSpectrum, Dr H Purushottam, advisor, TDB, outlines the unique features of the Board and its various initiatives. What is the mandate of the Technology Development Board? The Technology Development Board is the first organization of its kind within the government framework with the sole objective of translating the fruits of indigenous research into commercial products and services. The board plays a proactive role by encouraging commercial enterprises to take up technology-oriented projects. It offers soft loans to the Small and Medium Entreprises (SMEs), to technopreneurs, for commercializing new innovative indigenous technologies, for adapting foreign technologies to Indian conditions in terms of raw material and process. What are the unique features of the Board? The TDB is a unique institution operating in this arena in the country. Its role encompasses that of a venture capitalist and a financial institution but is still broader in scope. Besides the financial assistance, it offers handholding, techno marketing, mentoring, technical assistance and an enabling environment to the organization. Thus the board offers the best of both worlds to an entrepreneur. The TDB offers brand equity, which is evident from the fact that by leveraging its funds, the board has been able to mobilize about Rs 2,000 crore for the entrepreneurs from banks and other financial institutions. Secondly, the board funds about 50 percent of the total project cost and offers soft loans at the rate 5 percent simple interest in comparison to 13-14 percent interest charged by banks and financial institutions. The board does not levy processing, administrative or commitment charges. There is no levy of royalty too. The board has given a great boost to the first generation entrepreneurs and has created many success stories. At present we are collaborating with financial institutions, state financial cooperatives, commercial banks, industrial cooperatives and venture capitalists to leverage on TBD's techno financial resources to have a large impact on the society. What is the biggest strength of the TDB? The biggest strength of the TDB is its highly technically competent project evaluation committee, project monitoring committee, and the committee of experts. Before the approval of a project, the board does a technical appraisal of the submitted proposal. This is done so thoroughly that it is considered a benchmark. The success rate of screening of project proposals by the TDB is just 35-40 percent because of its stringent and scientific approval. Most of the banks and financial institutions to which the project is later submitted for further assistance, do not bother to do the technical appraisal again. The TDB has experts like Dr NK Gangualy, director general, ICMR, Prof G Padmanabhan, honorary professor, IISc, on its board, which help in the evaluation and feasibility study of projects. This is the primary reason for the high rate of success of the TDB and its brand equity. What is the time frame for approval of projects? The time taken for approval ranges from 2-4 months depending on the size of the funding required and the completeness of the application. If the project funding is to the tune of Rs 5 crore or less, then the time required for approval is about two months and if the funding required is between Rs 5 and 20 crore, then the time taken for approval is about 4 months. What are the new initiatives launched by the TDB? To leverage its investment, the TDB has joined hands with the private venture capitalists to provide equity to start-ups or companies in the growth phase. It is a part of the Rs 150-crore APIDC Venture Capital Fund, Hyderabad exclusively focused on biotechnology and the board's share is about Rs 30 crore in it. The TBD is also a part of the Rs 700-crore UTI VF's Ascent India Fund and Rs 115 crore UTI-ITUVS, Bangalore, which concentrate on IT, telecom, biotechnology, pharma and healthcare. These funds help in identifying potential entrepreneurs and start-ups. Another initiative is to provide seed funding to the Technology Business Incubators in the country. For this, five incubators have been selected and Rs one crore has been made available to each of them through the National Science and Technology Entrepreneur Development Board. This money shall be used by the incubator manager to help some of the potential technologies to arrive at the proof of concept stage. The shortlisted incubators are Vellore Institute of Technology, Vellore; JSS Academy, Noida; IIM Ahmedabad; IIT Mumbai; and Science and Technology Entrepreneur Park (STEP) Trichy. This initiative will help the entrepreneurs to arrive at the experimental proof of concept stage in their projects. We have recently signed an MoU recently with 'Anvar', France, an agency similar to the TDB in India, for synergizing on efforts in commercializing technologies in both the countries. The board has launched an aggressive outreach program too. The TDB along with the DST are coordinating the "Technology Day" award function for entrepreneurs for successful commercialization of indigenous technology. Rolly Dureha ]]> <![CDATA[TDB a premier institution promoting "BioVentures"]]> https://biospectrumindia.com/news/95/6404/tdb-a-premier-institution-promoting-bioventures.html https://biospectrumindia.com/news/95/6404/tdb-a-premier-institution-promoting-bioventures.html Tue, 10 May 2005 15:10:00 +0530 With the mantra of "Enabling Commercialization", the Technology Development Board has played a proactive role in nurturing the nascent biotechnology industry in the country. To give impetus to commercialization of indigenous technologies, the Government of India constituted the Technology Development Board (TDB) in September 1996, under the Technology Development Board Act, 1995. The Board provides financial assistance in the form of soft loan, equity or grant-in-aid to the industrial concerns and other agencies in the development and commercial application of indigenous technology or adapting imported technology to wider domestic applications. With the mantra of "Enabling Commercialization", the Board has played a proactive role in nurturing the nascent biotechnology industry in the country by making funds available for the commercialization of Indian biotech products and technologies. The success stories of Shantha Biotechnics, Bharat Biotech and many other companies in this sector would be incomplete without the support of the TDB. In fact, Shantha Biotechnics was the first commercial enterprise with which the Board had signed an agreement for providing loan assistance to develop and commercialize Hepatitis B vaccine way back in 1997. Later in 2002, it assisted Shantha in developing India's first recombinant human Interferon - Shanferon. Similarly, it helped Bharat Biotech International to develop Revac-B (Recombinant vaccine for Hepatitis-B) and Indikinase (recombinant Streptokinase), Ranbaxy for indigenous development and application of anti-infectives, Biocon in the production of an immuno-suppressant through a unique fermentation technology. The list is long. Till date, the TBD has invested in 16 states in the country and funded a broad spectrum of 140 projects. Of this about 42 (more than 1/3) are in the field of drugs and pharma including the biopharma sector. In terms of investment in companies, this amounts to Rs 200 crore out of a total of Rs 600 crore (nearly 30 percent of its total investment) in this segment. Looking at the profile of beneficiaries, especially in the biotech space, it clearly emerges that the TDB is a champion of first generation technopreneurs. More than 60 percent of its protÃ©gÃ©s are first generation entrepreneurs out of which nearly 75 percent have proved to be extremely successful. "TDB's role encompasses that of a venture capitalist and a financial institution but is still broader in scope" In a chat with with BioSpectrum, Dr H Purushottam, advisor, TDB, outlines the unique features of the Board and its various initiatives. What is the mandate of the Technology Development Board? The Technology Development Board is the first organization of its kind within the government framework with the sole objective of translating the fruits of indigenous research into commercial products and services. The board plays a proactive role by encouraging commercial enterprises to take up technology-oriented projects. It offers soft loans to the Small and Medium Entreprises (SMEs), to technopreneurs, for commercializing new innovative indigenous technologies, for adapting foreign technologies to Indian conditions in terms of raw material and process. What are the unique features of the Board? The TDB is a unique institution operating in this arena in the country. Its role encompasses that of a venture capitalist and a financial institution but is still broader in scope. Besides the financial assistance, it offers handholding, techno marketing, mentoring, technical assistance and an enabling environment to the organization. Thus the board offers the best of both worlds to an entrepreneur. The TDB offers brand equity, which is evident from the fact that by leveraging its funds, the board has been able to mobilize about Rs 2,000 crore for the entrepreneurs from banks and other financial institutions. Secondly, the board funds about 50 percent of the total project cost and offers soft loans at the rate 5 percent simple interest in comparison to 13-14 percent interest charged by banks and financial institutions. The board does not levy processing, administrative or commitment charges. There is no levy of royalty too. The board has given a great boost to the first generation entrepreneurs and has created many success stories. At present we are collaborating with financial institutions, state financial cooperatives, commercial banks, industrial cooperatives and venture capitalists to leverage on TBD's techno financial resources to have a large impact on the society. What is the biggest strength of the TDB? The biggest strength of the TDB is its highly technically competent project evaluation committee, project monitoring committee, and the committee of experts. Before the approval of a project, the board does a technical appraisal of the submitted proposal. This is done so thoroughly that it is considered a benchmark. The success rate of screening of project proposals by the TDB is just 35-40 percent because of its stringent and scientific approval. Most of the banks and financial institutions to which the project is later submitted for further assistance, do not bother to do the technical appraisal again. The TDB has experts like Dr NK Gangualy, director general, ICMR, Prof G Padmanabhan, honorary professor, IISc, on its board, which help in the evaluation and feasibility study of projects. This is the primary reason for the high rate of success of the TDB and its brand equity. What is the time frame for approval of projects? The time taken for approval ranges from 2-4 months depending on the size of the funding required and the completeness of the application. If the project funding is to the tune of Rs 5 crore or less, then the time required for approval is about two months and if the funding required is between Rs 5 and 20 crore, then the time taken for approval is about 4 months. What are the new initiatives launched by the TDB? To leverage its investment, the TDB has joined hands with the private venture capitalists to provide equity to start-ups or companies in the growth phase. It is a part of the Rs 150-crore APIDC Venture Capital Fund, Hyderabad exclusively focused on biotechnology and the board's share is about Rs 30 crore in it. The TBD is also a part of the Rs 700-crore UTI VF's Ascent India Fund and Rs 115 crore UTI-ITUVS, Bangalore, which concentrate on IT, telecom, biotechnology, pharma and healthcare. These funds help in identifying potential entrepreneurs and start-ups. Another initiative is to provide seed funding to the Technology Business Incubators in the country. For this, five incubators have been selected and Rs one crore has been made available to each of them through the National Science and Technology Entrepreneur Development Board. This money shall be used by the incubator manager to help some of the potential technologies to arrive at the proof of concept stage. The shortlisted incubators are Vellore Institute of Technology, Vellore; JSS Academy, Noida; IIM Ahmedabad; IIT Mumbai; and Science and Technology Entrepreneur Park (STEP) Trichy. This initiative will help the entrepreneurs to arrive at the experimental proof of concept stage in their projects. We have recently signed an MoU recently with 'Anvar', France, an agency similar to the TDB in India, for synergizing on efforts in commercializing technologies in both the countries. The board has launched an aggressive outreach program too. The TDB along with the DST are coordinating the "Technology Day" award function for entrepreneurs for successful commercialization of indigenous technology. Rolly Dureha ]]> <![CDATA[Industry's suggestions on National BT Policy]]> https://biospectrumindia.com/news/95/7766/industrys-suggestions-on-national-bt-policy.html https://biospectrumindia.com/news/95/7766/industrys-suggestions-on-national-bt-policy.html Tue, 10 May 2005 15:01:00 +0530 Anuradha Acharya, CEO, Ocimum Biosolutions, Hyderabad While many good things have emerged from this report, there are still some things lacking. Indian Biotech lacks basic infrastructure, funds and consumables. This leads to the perennial problem of resorting to areas where companies can generate revenue and generate cash flows for short term. The vision of the government has to be long term and to improve the health of the country as a priority. Biotech parks are an excellent idea. A suggestion would be the location. Since they are located so far from the city that a whole new infrastructure needs to be created to support people working in these parks. Also in order to encourage young companies, some basic infrastructure and computing power would be a necessity. In the bioinformatics area, the quantity has increased tremendously but the quality still hasn't. The numbers suggested in the report for Bioinformatics are pretty high. If we really need that many people, we would have to increase the scope of our industry and the type of work we do A central library maintained by the DBT which scientists can have access to for a minimal charge of, say Rs 500 per year can facilitate access to scientific information. Suggestions of the All India Biotech Association (AIBA), New Delhi In the Draft Biotech Policy, there is no mention about custom duty concession on biotechnology equipment as well as raw materials. It will be noted that Information Technology Industry has developed rapidly because of concessions provided by the government on custom duties on imported equipment and packages. It is therefore necessary that at least for next 10 years, the custom duty on import of equipment for biotech industry and R&D, whether in public or private sector, is totally waived off or a very nominal amount may be fixed. Likewise, it is very essential that custom duty on import of raw materials required for Biotech products should be abolished.  Biotechnology ventures require high investment and long gestation period. Even if, a small percentage of enterprise, funded through venture capital succeeds, it can make good for the failures. In our country the situation is very much different with the venture capitalists. This needs to be looked into and clear guidelines provided for venture capitalists. On the whole, the Draft policy document is good and needs to be implemented in letter and spirit as early as possible. It is further felt that it would be advisable if the state governments also formulate biotech policies on similar lines. Suggestions from the state secretariesMK Shankaralinge Gowda, IT and BT secretary, Government of Karnataka, Bangalore The policy should allow state governments to have their own road maps and encourage capacity-building. This will allow the governments to choose their areas of work. There is a need for standardization of biotech education in the country in order to ensure the availability of skilled and trained manpower for the various segments of the biotech sector. Dr D A Ashok, director of biotechnology, Government of Andhra Pradesh, Hyderabad BT policy was integrated approach towards promoting biotechnology. There is a need for a unified national body to safeguard the interests of all the states and address issues The Central government should encourage the development of biotech clusters and woo scientists of Indian origin to return to India and create start-ups by formulating a special scheme to encourage and motivate them. M J Dashora, managing director, Accurex BioMedical Pvt Ltd, Mumbai It is very well drafted report. The persons who drafted this have considered the future and scope of the diagnostic kits in India. However, there are some reservations. Some importance to pathology labs and diagnostics is missing or overshadowed by pharmacology/ pharmacokinetics. There is nothing about the education programs to train people working in pathology labs. It should have included upgradation of the pathology labs with accreditation from National Accreditation Board for Testing and Calibration Laboratories (NABL). Qualification should be made mandatory for persons working in the labs as at present, unqualified persons are handling the tests. There is no mention about the insurance/medi claim in the strategic action. It should be made mandatory through law through which we can achieve preventive and progressive healthcare in India. Dr Arun Bhatt, president, ClinInvent Research Pvt Ltd, Mumbai Some of the areas in clinical research are overlapping with general recommendations e.g., regulatory issues, training, GCP, Ethics. However, there is no time frame for streamlining of regulatory process at RCGM and DCGI inter-phase level. Besides, the suggestion of making a GCP manual will create another guideline to follow! We already have ICMR guidelines, Indian GCP guidelines, new Schedule Y and ICH-GCP. Another GCP for biotechnology will only confuse the sponsors and investigators. There is also a need to think of training beyond imparting knowledge. Clinical research also requires several skills - communication, interpersonal, time management etc. As the supply of medical and other talent is limited and as the demand is very high, there is also a need to create accredited public/private educational institutions across the country rapidly to meet the demand. Kirit S Javali, partner, Jafa & Javali Advocates, Delhi There is a need for harmonization of the various legislations governing the biotechnology sector such as the Environment (Protection) Act, 1986, The Rules for the Manufacture, Use, Import, Export and Storage of Hazardous Micro Organisms Genetically Engineered Organisms or Cells, 1989, Drugs & Cosmetics Act, 1940 and Department of Biotechnology Guidelines, 1998. For an effective regulatory system to be in place, the regulatory agencies should have clear legal jurisdiction and authority over all products and activities that may pose a risk to human health or the environment. It is also important that the national biotechnology development strategy addresses the critical issue of safety of food products especially GM food and the issue of labeling. The Government of India should also consider establishing appropriate mechanisms to ensure effective protection of IPR and to commercially exploit the protected IP reasonably. There has to be an effective national monitoring and enforcement capacity. The best laws, regulatory mechanisms, and scientific expertise will be of little use if there is no effective monitoring and enforcement capability to ensure sound biosafety regulation. Dr Krishna M Ella, chairman of FICCI biotech committee and managing director, Bharat Biotech International Ltd, Hyderabad The policy rightly puts the spotlight on the HR problem plaguing the biotech industry in India. The creation of a National Task Force to formulate model undergraduate and postgraduate curricula in Life Sciences keeping in view, future needs is particularly laudable. Innovation will receive a boost through the creation of Institute Innovation grants through the Department of Biotechnology to fund academic researchers to develop their concepts into patentable and more importantly, licensable technologies. However, when it comes to standardizing the Biotech curricula, there is no single body or a council created that could be responsible for this year after year and to review the trends in the industry. The proposed initiative to institute a 'Small Business Innovation Research Initiative' (SBIRI) scheme through the DBT in 2005-06 is a welcome sign. However the loan amount could have been bigger considering the industry's capital-intensive needs. There has to be more clarity on clinical trail regulatory issues. Aluri Srinivasa Rao, director, investments, ICICI Venture Funds, Mumbai We definitely need a drastic look at the industrial side of the policy. It has clearly stated that biotech will be a component of any industrial policy - be it public health, environment, and agriculture, which the government announces. You have to show the money as "big money" to all the development stated in the BT draft policy to happen. This is not going to happen with incremental loans, though it can be the starting point. It needs different kinds of money. Israel can be taken as an example. The government there instead of giving TDB, NIMTLI kind of monies, they created a structure where it said it would give money to an body who needs it, but that the government is not the right agency to handle it. So the government needs to make the fund happen. The Policy draft can address this issue by saying that the government will make available 1 percent of forex reserves of $135 billion as a fund for life sciences. Then you are talking about big money. There can be structure where the professionals or VCs can fund the promising biotech. This will give much higher returns than being in the forex reserves. ]]> <![CDATA[Thermo releases micromax microcentrifuge]]> https://biospectrumindia.com/news/95/5862/thermo-releases-micromax-microcentrifuge.html https://biospectrumindia.com/news/95/5862/thermo-releases-micromax-microcentrifuge.html Tue, 10 May 2005 14:57:00 +0530 Thermo Electron Corporation has released micromax microcentrifuge to the worldwide market including Asia and Europe. The refrigerated and ventilated micromax models combine sophistication, performance and affordability. Micromax's powerful, quiet performance and attractive, compact styling will appeal to professionals in a range of settings, such as DNA/RNA molecular biology, clinical and forensic labs. The units are easy to operate and clean. Glove-friendly control panel includes an easy-to-read display. The micromax is capable of producing force up to 21,000 xg at speeds of 15,000 rpm for more separating power. It accelerates to full speed in less than 15 seconds, minimizing wait time. Control over g-force, braking rates, and timing ensures greater centrifugation consistency. Controls are microprocessor-based for added reliability. For details, contact: bimal.desai@thermo.com Mass spectrometers from Applied Biosystems Applied Biosystems Group, an Applera Corporation business, together with its joint venture partner MDS Sciex, a division of MDS Inc, has announced the launch of three new mass spectrometers, the 3200 Q TRAP and the API 3200 LC/MS/MS Systems with Turbo V Source for added sensitivity, throughput, and cost-effectiveness in mass spectrometry-based workflows. These systems are designed for food and beverage, environmental, forensic, clinical research, and pharmaceutical analysis markets. By incorporating the Applied Biosystems/MDS SCIEX proven Turbo V source and API 4000 LC/MS/MS System-series interface and ionization sources into a smaller platform, these new systems provide increased sensitivity, greater flexibility, and improved ease-of-use. The ceramic interface of the API 3200 and 3200 Q TRAP LC/MS/MS Systems reduces chemical background and improves sensitivity under LC conditions, yielding better efficiency, relative to older source technologies, especially at higher flow rates. The API 3200 LC/MS/MS System with Turbo V source is a triple quadrupole for quantitation and analyte detection studies. The system provides improved performance, especially at high flow rates, allowing for easy method transfer from LC/UV to LC/MS/MS workflows. This method transfer to LC/MS/MS workflows offers the advantages of improved sensitivity, speed, and simplified sample preparation in the pharmaceutical analysis, environmental, and forensic markets. Additionally, because the Turbo V source family is now compatible with five Applied Biosystems/MDS SCIEX LC/MS/MS systems, method development can be carried out on these new instruments with simple transfer to the higher sensitivity systems. These mass spectrometers are being distributed in India by Gurgaon-based Lab India Instruments. For further details, contact: raiv@labindia.com Ocimum Biosolutions introduces OciChips Ocimum Biosolutions has launched OciChips, DNA microarrays recently acquired from MWG Biotech. DNA-microarrays, also known as biochips, are tools of increasing importance for academia and industry for basic research and for increasing the understanding of the influences of a multitude of factors on disease processes. The products in the area of array technology at MWG presently include hybridization service, catalog arrays, oligo sets, consumable and kits, software and array user information. Ocimum will take over MWG's portfolio of biochips on the complete genomes of a multitude of model organisms (including rat, mouse, zebra fish, etc.) as well as a biochip representing the complete human genome. For more information, contact: bdm@ocimumbio.com. Dynex's Triad series of multimode readers available in India The TRIAD series of multimode readers from Dynex Technologies provide flexibility for a variety of application needs. It is capable of performing fluorescence, luminescence and absorbance measurements. The TRIAD series is suited for a broad range of applications including protein and enzyme studies, molecular biology, and even cell-based assays. The unique instrument design of the TRIAD series utilizes Dynabrite led-based detection optics to ensure excellent performance in all detection modes. A wide range of filter slides allow researchers to both customize and expand the capabilities of their TRIAD systems as their needs change. It is powered by a highly intuitive instrument operating software package for ease of use and flexibility thus making the implementation and analysis of even complex protocols simple. The Triad series is being distributed in India exclusively by the Chandigarh-based Imperial Bio-Medic P Ltd. For further details, contact: ibmplch@sancharnet.in ]]> <![CDATA[News Bytes - Suppliers]]> https://biospectrumindia.com/news/95/1947/news-bytes-suppliers.html https://biospectrumindia.com/news/95/1947/news-bytes-suppliers.html Tue, 10 May 2005 14:55:00 +0530 MPCB gets gift from Chemito On the occasion of visit of Crown Prince Philippe of Belgium, Duke of Brabant to Mumbai, on a federal trade mission, AppliTek NV/SA, Belgium and Chemito Technologies Pvt Ltd, jointly gifted AppliTOC (On-line TOC Analyser) to Maharashtra Pollution Control Board (MPCB), Mumbai. Mumbai-based Chemito has a business alliance with AppliTek NV/SA, Belgium to market the latter's products in India. Waters publishes new life science catalog For scientists working in well-characterized biopharmaceuticals, protein and peptide isolation and characterization, proteomics research, and amino acid analysis, Waters Corporation has recently published its latest life science chemistry solutions brochure. This catalog features an array of Waters life science chemistry solutions, including reagents and chromatography-based products for HPLC, MS, and LC/MS applications. Millipore makes it to Business Ethics Top 100 Millipore was ranked among the Top 100 companies selected by Business Ethics, the international magazine dedicated to corporate responsibility, in their issue of Spring 2005. The companies are rated on aspects like total returns to shareholders, community, employees , the environment , human rights and customers. A new category of stakeholder service added this year is governance. The 2005 list marks the sixth anniversary and over that time KLD Research And A Boston has been the consistent source of social data for the study. In a similar study done earlier by Global Finance magazine, Millipore was rated among the top most companies in the area of 'Socially Most Responsible Companies.' Imperial gains distribution rights of Dynex products Chandigarh-based Imperial Bio-Medic, which offers a broad portfolio of research products and services to the biotech industry, has tied up with the US-based Dynex Technologies, which manufactures instruments and accessories for a broad range of scientific applications, while offering specialized services for the customers. Imperial has gained the exclusive distribution rights of Dynex products in India. Neeraj Gupta, corporate vice president, Imperial Bio-Medic, said, "Imperial in its pursuit of expansion and excellence in terms of service, support and expertise has tied up with Dynex. The platforms from Dynex have exhibited high quality standards with diversified applications and thus helping Imperial to realize its goal of being a total solution provider." Fabtech receives CE certification Fabtech Technologies International Pvt Ltd has received 'Conformite Europene' (CE) certification for its 'Prefabricated Panels'. These panels comply with EU GMP norms for health, safety and environment. With this, Fabtech's panels can now be supplied anywhere in Europe or in countries where EU GMP standards are accepted. Fabtech has rolled out its first state-of-the-art complete ampoule filling line, which was fabricated at its facility in Umergaon, north of Mumbai. "To start with, we will manufacture sterilizing tunnels. The selection of sterilizing tunnels as the first product to be launched from this facility is a logical extension to our range of sterilizing equipments and sterile area specialization. The existing facility too has geared up to manufacture the full range of cleanroom equipment and modular panels. Many more such lines are slated to roll out of the Umergaon facility this year," said K Aasif, director, Fabtech Technologies. Praj receives SESI award Praj Industries Ltd has received the Solar Energy Society of India (SESI) Business Leadership Award for Bio-fuels for the year 2004. Praj Industry bagged the award for developing and promoting appropriate innovative technologies for accelerated commercial development of ethanol using multifuel options with a thrust on agro and rural industries for employment and energy security. Dilip Valse Patil, minister of energy, government of Maharashtra, presented the award to Pramod Chaudhari, chairman, Praj Industries at the International Congress for Renewable Energy (ICORE 2005) held in Pune. Vinay Kore, minister of non-conventional energy, was also present. SESI is the Indian section of the International Solar Energy Society (ISES) and is based in Delhi. ]]> <![CDATA[Reagent Market: Imports Rule the Roost]]> https://biospectrumindia.com/news/95/2284/reagent-market-imports-rule-the-roost.html https://biospectrumindia.com/news/95/2284/reagent-market-imports-rule-the-roost.html Tue, 10 May 2005 14:53:00 +0530 A wide range of chemicals and reagents manufactured by foreign companies are now available in India. The Indian biotechnology reagent market is primarily import-oriented. There are very few indigenous manufacturers operating in this space. Bangalore Genei, now a subsidiary of Sanmar Speciality Chemicals, is one of the prominent Indian manufacturers engaged in making reagent chemicals for genetic engineering and molecular biology research. Almost the entire industry comprises of either Indian subsidiaries of multinationals like Becton Dickinson, Bio-Rad or resellers like Genetix Biotech Asia, Imperial Biomedics, Medi Spec, Axygen Scientific, Jain Biologicals, Biotech India and many others. Presently the biotech consumables and reagent market of India is growing. Today the total reagents industry segment is worth Rs 50-70 crore in India and it is growing at the rate of 25-30 percent. "The growth has been smooth and the total reagent business of Genetix has increased by about 50 percent during the last year which is indicative of good growth of the industry," said Arun Prakash, CEO of Delhi-based Genetix India. "The growth trend is very encouraging. For example, if we consider just the PCR market, the size can be estimated around $11 million for PCR consumables alone (per year in India). With a growth of 30 percent every year, we can well imagine the market after five years and is expected to be the fastest growing market after IT enabled services," said Neeraj Gupta, corporate vice president of Imperial Bio-Medics. Dr Rupinder Singh, business manager, Reagents and Labware, BD BioSciences, feels, "The volume of business has increased. Compared to last year, it seems that government customers have better buying power. Pharma R&D customers are not increasing their spending much with the focus still hovering around generic manufacturing." But nevertheless, a start has been made and many pharma companies involved in biotech research are shifting their focus towards new molecules. "Presently the sale of reagents for CD4 testing in case of HIV infected individuals is on the increase. This test is used for monitoring effect of anti retroviral therapy on AIDS progression," shares Dr Singh of BD BioSciences. A bulk of biotech reagents/consumables used in India are imported, though the country has a mature successful chemical industry. Why? "The fact is that the successful chemical industry cannot be used as a referral point for the biotech reagent industry at the very first step. Actually the biotech reagent industry demands the merger of chemical, microbiological and speciality enzyme industry and due to lack of adequate infrastructure, this has not been successful as yet. Also, the quality control standards for the existing industries are not very stringent as required in this segment, thus the researchers are not able to trust the indigenous manufacturers and are ready to pay extra cost for the foreign products,"counters Neeraj Gupta. "The indigenous manufacturing of reagents is not done as they are not properly standardized. There may be production inconsistencies, the strong mind share of scientists captured by the international brands, and a lack of initiative on the part of the Indian manufacturers," opines Arun Prakash. It is believed that if in India indigenous manufacturing takes off, then the cost would see a 100 percent or sometimes 150 percent reduction. Along with the low cost of manufacturing, the companies would be able to save on the freight charges, import duties and other incentives offered by the government like exemption from central sales tax and excise duty. It will help the researchers to enjoy cost effectiveness at cheaper prices thus giving them value for money. But the process of standardization has to be put in place first. At present, it is felt that the levels of investment required for a quality control system at par with international standards may simply not justify the volumes required by the Indian market alone. And for tapping markets abroad, they will face a stiff competition from the already established players. So joint venture possibilities could be an ideal option. "The government can change the current import trend but only by having very serious efforts to woo entrepreneurs and researchers into this area. The other way this problem could be tackled is by wooing foreign manufacturers to set up manufacturing base here and by boosting research culture to the next level," said Dr Singh of BD India. The key customers of the various companies are the life science research labs/institutes, government and public hospitals, universities, biotech and pharma industry. Foreign brands like Bioline, Promega and Invitrogen and Hyclone have a very strong mind share amongst the Indian scientists as products of these companies have had their presence in India since the past 5-7 years since molecular biology/biotechnology took roots in the country. Also due to the present limited range of indigenous reagents available, there are compatibility issues of indigenous with the imported reagents. On an average the imported reagents are expensive but sometimes due to the volumes of production involved, some imported chemicals are sold at cheaper rates than their indigenously available counterparts. Commenting on the business model, VK Dubey, CEO, Biotech India, which represents international brands like R&D systems, SantaCruz Biotechnology, SuperArray Bioscience Corp., RayBiotech Inc., says, "Essentially the sale of reagents or any other product depends on the better product quality, better service and the discounts offered. This business is afterall a play of volumes". The big distributors have huge stockpiles, like for example Genetix, at any given time, stocks 8-10 thousand different reagents worth about Rs 3 crore. And its turnover during the 2004-05 has been more than Rs 30 crore. Most of the distributors procure huge stocks and thus the freight charges/per product gets distributed. Discounts in the range of 5-7 percent are common to customers. The business offers margins in the range of 15 to 30 percent, which the industry feels is justified as there are many highly perishable consumables, requiring specific storage conditions. So there has to be an adequate cushion for the risk elements. The Indian market is sensitive to the pricing of new products. Scientists ideally want accuracy with economical pricing. The market statistics may change in the near future, with countries like China, Korea and Taiwan coming up in a big way in the area of consumables manufacturing. These countries are targeting the Indian market seriously and are in fact keenly looking at the Indian companies for partnerships. Commenting about the key issues/hurdles facing the industry, Dubey said, "The duties are a bottleneck, though some concessions have been announced by the government in the recent budget but they should be on a broader scale. Secondly, the import process is very cumbersome and should be streamlined. Dhiren Wagle, country manager, Bio-Rad, feels, "Most of the government customers are duty exempted but to make available these reagents in Indian rupees attract duties which makes the reagents costlier; logistically many of the reagents are short shelf life and temperature sensitive; and stocking is inhibitive as irrespective of the customer segment, it attracts duties". Another apprehension, voiced by Neeraj Gupta is the price war that has started these days, especially in the fast running consumables market like PCR reagents. This has shifted the focus of the reagent manufacturers towards prices rather than quality, which is henceforth responsible for the attractive schemes with compromisable quality. Rolly Dureha ]]> <![CDATA[Stem cell separation through cryogel]]> https://biospectrumindia.com/news/95/1226/stem-cell-separation-through-cryogel.html https://biospectrumindia.com/news/95/1226/stem-cell-separation-through-cryogel.html Tue, 10 May 2005 14:51:00 +0530 A new affinity chromatography column has been developed for cell separation systems. With the advent of new sciences and technologies, there has been a need for developing new polymers, materials and techniques to put the novel knowledge into application. For instance, both in the areas of biomedical research and diagnostic medicine, it is vital to have specific separation of a discrete population of cells from a mixture. Through cell separation applications like fluorescence-assisted cell sorting via flow cytometry; density-gradient-based methods and magnetic-particle-based methods, a particular type of cell can be isolated from a complex mixture. The isolation of specific cell sub-populations is a key factor to the advancement of cell-based therapies of cancer, auto-immune diseases and genetic disorders. Dr Ashok Kumar Dr Ashok Kumar, associate professor, department of biological sciences and bioengineering, IIT Kanpur, along with his team has designed a "cryogel" that is, a polymeric gel formed in moderately frozen media, having a continuous system of interconnected macropores which is capable of separating stem cells. He selected to work on developing a novel affinity chromatography column (the cryogel) because though magnetic separation and flow cytometry represent the most powerful tools for cell separations, they are limited to analytical applications. Owing to low cost and simple operation, cell affinity chromatography is considered the preferred approach when the application is preparative scale separation. "The choice of a suitable matrix material is important because, as separation objects, cells are relatively large and are rather fragile and sensitive to shear stress. Their diffusivity is negligible and only convective transport can be used. Thus, for cell affinity chromatography the key element is the design of the matrix", said Dr Kumar. Cryogel as matrix The cryogels are essentially gel matrices that are formed in moderately frozen solutions of monomeric or polymeric precursors. They typically have interconnected macropores or supermacropores with a size of 10-100 µm, allowing unhindered diffusion of solutes of practically any size, as well as mass transport of nano and even microparticles. The unique structure of cryogels, in combination with their osmotic, chemical and mechanical stability, makes them attractive matrices for chromatography of biological nanoparticles (plasmids, viruses, cell organelles) and even whole cells. Model for stem cell separation To demonstrate that stem cell separation can take place through the cryogel column, the researchers selected the human acute myeloid leukemia cells having CD34+ cell surface receptor. After labeling these CD34+ cells with anti CD34+ monoclonal antibodies, labeled cells were found specifically bound to Protein A-carrying supermacroporous monolithic column when passed through it. The viable CD34+ cells were later eluted when free non-specific cheap antibodies displaced cell-bound specific antibodies. The CD34+ surface antigen is recognized as an important marker for hematopoietic stem cells. Thus, the scientists concluded that the system could be a good model for the separation of CD34+ cells from bone marrow or peripheral blood. Earlier, the researchers also demonstrated specific fractionation of T- and B-lymphocytes from human blood using antibodies against surface receptors of B-cells. Benefitsa In addition to a simple and elegant model for stem cell separation, the cryogel allows maximum recovery as it is a hydrophilic polymer on which the cells do not adsorb non-specifically. The other significant advantage is that there is no need for any approval from the regulatory authorities, since they are produced from exactly the same polymers as used in traditional chromatographic materials, which are already approved by regulators. All the synthetic chemistry used at present to prepare chromatographic materials is also applicable to cryogels. It has no other added chemicals and only ice crystals serve as porogen. The same standard low-pressure chromatographic systems can be used with cryogels. Elaborating further about its advantages, Dr Kumar said, "Cryogels are extremely easy to handle and put in a column. They can be dried and re-swollen directly in the column. Due to the high polymer concentration in the walls of large interconnected pores, they are elastic. The monolith is easily removed and placed back in the column with no leakage in between the monolith and the column walls. Thus, there is no by-pass and the elastic gel monolith sits tightly in the column". The cryogel can also be produced in different sizes and formats (rods, sheets, discs, microtiter plates, etc) with different pore sizes (0.1-100 µm). Lastly, as compared to magnetic beads they can be applied for both positive and negative selection of viable cells. There is also an efficient and economic use of the expensive monoclonal antibodies as no chemical attachment or immobilization of monoclonal antibodies is required. And there is no restructuring of the column required as the same column type is used for the separation of different cells, besides the ease and simplicity of operation. "At present we are now both expanding the application of the affinity cryogel adsorbents to other cell separation processes and also simultaneously linking up with biomedical research laboratories and industries for further evaluation of gels on stem cell separation systems," said Dr Kumar.n ]]> <![CDATA[World's first blue rose developed]]> https://biospectrumindia.com/news/95/2030/worlds-first-blue-rose-developed.html https://biospectrumindia.com/news/95/2030/worlds-first-blue-rose-developed.html Tue, 10 May 2005 14:48:00 +0530 Australian and Japanese researchers have demonstrated the application of RNAi (gene silencing) technology for gene replacement in plants, developing the first blue rose in the world. Till date, breeders have attempted to make true blue roses over many years, but none have successfully bred roses with blue pigment. The RNAi technology developed by the Commonwealth Scientific and Industrial Research Organization (CSIRO) was a key technology used under license by Florigene, a Melbourne-based biotechnology company and part of the Japanese Suntory group of companies to develop the rose. In order to develop a blue rose with a "true blue" pigment, three steps had to be achieved: turn off the production of red pigment; open the 'door' to production of blue pigment; and then produce blue pigment. The RNAi technology was used to remove the gene encoding the enzyme dihydroflavonol reductase (DFR) in roses. DFR works to create intermeencing was used to knock out the activity of the rose DFR gene and then a DFR gene from iris, which makes a lotdiates that are subsequently made into red or blue pigments, but rose DFR does not appear optimal for production of blue pigments. Gene sil of blue pigment, replaced it to produce a blue rose. Gene replacement is considered a rare event in plants, with researchers only able to either add genes as in the case of insect-resistant cotton, or knock out the activity of an existing gene such as in the development of canola from rapeseed. To be able to turn that around is significant in plant biotechnology, providing researchers with a reliable mechanism to explore improvements in economically significant plants that may have otherwise taken years. Gene replacement in plants is such a rare event that till date it was considered almost impossible to achieve. Though Florigene has already successfully created blue carnations using gene technology and these have been available in Australia since 1996, it will be at least three years before blue roses will be commercially available in Australia, pending approval from the Office of the Gene Technology Regulator for their commercial release.   ]]> <![CDATA[Wockhardt appoints Dr Yatendra as president-R&D]]> https://biospectrumindia.com/news/95/2590/wockhardt-appoints-dr-yatendra-as-president-rd.html https://biospectrumindia.com/news/95/2590/wockhardt-appoints-dr-yatendra-as-president-rd.html Tue, 10 May 2005 14:48:00 +0530 Wockhardt, a pharmaceutical and biotechnology major, has appointed Dr Yatendra Kumar as president-R&D, to drive its growth in the US and European generic formulations and active pharmaceutical ingredients (API) markets. Dr Kumar has over 100 patents in his name and has published 22 research papers during a long research career in American universities and Astra of Sweden. Pfizer names Kewal Handa its MD Pfizer has announced that Kewal Handa has been appointed as managing director, Pfizer Ltd, India. Prior to this, Kewal served as executive director-Finance, Pfizer Ltd. He succeeds Hocine Sidi Said as the leader of the Pfizer's India operations who had spent four years in India as managing director. During his fifteen years with the company, Kewal Handa has been entrusted with positions of increasing responsibility. He has a broad range of experience and has risen above his portfolio as Chief Financial Officer (CFO) by being a key contributor to shaping the future of Pfizer. He has demonstrated leadership and excellence in strategically guiding Pfizer Limited through two mergers with Parke Davis - Warner Lambert (India) Private Limited and Pharmacia. Handa is recognized as an industry expert on issues concerning the pharmaceutical sector. As chairman of the Pricing Committee of the Organization of Pharmaceutical Producers of India (OPPI), he has been at the forefront of the industry's efforts to resolve issues pertaining to the pharmaceutical sector. Handa is also a committee member of the Confederation of Indian Industry (CII), Indian Pharmaceutical Alliance (IPA) and the Bombay Chamber of Commerce and Industry (BCCI). He currently serves as president of the Bombay Management Association (BMA). He was recently awarded the 'India CFO 2004-Excellence in Finance in MNC' by the International Market Assessment Group Lupin appoints Dr Sudershan Arora as president of NCE research Lupin Ltd has appointed Dr Sudershan Arora as president of NCE research. In his earlier stint in Lupin, Dr Arora had led the company into filing four new drug applications for NCE, including Psoriasis and Tuberculosis. These molecules are at different stages of clinical trials. "The company takes great pleasure in welcoming back Dr Arora and will benefit immensely from his vast knowledge and rich experience in the area of NCE research," Dr D B Gupta, chairman of Lupin Ltd, said. ]]> <![CDATA[Padma Awards Presented]]> https://biospectrumindia.com/news/95/2834/padma-awards-presented.html https://biospectrumindia.com/news/95/2834/padma-awards-presented.html Tue, 10 May 2005 14:46:00 +0530 At a glittering ceremony in the last week of March, at the forecourt of the Rashtrapati Bhavan, President Dr APJ Abdul Kalam presented the nation's highest civilian honors Padma Awards to prominent persons chosen for the Republic Day honors this year. The Padma Awards were bestowed on five leaders from biotech and life science companies. The government of Karnataka too felicitated these Padma Awardees in April at Bangalore Bio 2005. A photo feature on the same. Kiran Mazumdar-Shaw, CMD, Biocon Ltd, honored with the Padma Bhushan by President Dr Kalam. K Varaprasad Reddy, managing director, Shantha Biotechnics, receives Padma Bhushan award from Dr Kalam. Dr Kalam presents the Padma Shri to Dr Cyrus Soli Poonawalla, chairman, Serum Institute of India Ltd. Prof VS Ramamurthy, Secretary, Department of Science & Technology, recieves the Padma Bhushan from Dr Kalam. Karnataka industries minister, PGR Sindhia felicitates Padma Bhushan Kiran Mazumdar-Shaw and Padma Bhushan Prof VS Ramamurthy at Bangalore Bio on April 23. MK Shankaralinge Gowda, IT&BT Secretary, Government of Karnataka, looks on. ]]> <![CDATA[Bt cotton row: Who stands to gain?]]> https://biospectrumindia.com/news/95/1258/bt-cotton-row-who-stands-to-gain.html https://biospectrumindia.com/news/95/1258/bt-cotton-row-who-stands-to-gain.html Tue, 10 May 2005 14:42:00 +0530 The GEAC has deferred its decision on extending the approval period for three varieties of Mahyco's Bt cotton. But the season for sowing cotton in India begins in April and will continue till August. On April 13, 2005 the Genetic Engineering Approval Committee (GEAC) deferred its decision on extending the approval period for three varieties of Mahyco's Bt cotton namely Mech-12 Bt, Mech-162 Bt and Mech-184 Bt, which ended on March 31, 2005. Even in its previous sitting on March 6, the GEAC failed to take a final decision on the matter. The next meeting of GEAC is scheduled on May 11. Meanwhile, the GEAC has sought reports from state governments about the performance of these three varieties. The GEAC has taken this decision on account of adverse reports from the Andhra Pradesh government and also due to pressure from non-governmental organizations and environmental outfits. These varieties developed by Mahyco with imported technology from Monsanto received approval for commercial cultivation in six states - Andhra Pradesh, Karnataka, Maharashtra, Tamil Nadu, Gujarat and Madhya Pradesh. The GEAC gave its approval to Mahyco for a period of three years on March 29, 2002 after going through the results of the field trials conducted over a period of five years. As the approval period was for three years, it is now due for a review of the performance for subsequent extension of the approval or otherwise. Since its launch in 2002, Mahyco Monsanto Biotech India Ltd (MMB), a marketing arm of the 50-50 joint venture between Mahyco and Monsanto Holdings Private Ltd, has sold about 72,000 packets of bollgard in 2002, 230,000 packets in 2003 and 13,00,000 packets in 2004 at Rs 1600 per packet. This indicates that the demand is growing for the use of Bt cotton in India. According to a market research by IMRB, this year the demand is expected to be approximately three times last year's actual sales. Now many non-governmental organizations, farmers' associations and environmental organizations have been raising voice against Bt cotton citing environmental hazards. Their contention is that it is not lucrative for farmers and have demanded compensation from the seed company to farmers who suffered losses. Contrary to the views of NGOs, the International Service for the Acquisition of Agri-Biotech Applications (ISAAA) in its 2004 report noted, "Bt cotton has the potential to reduce the requirements for cotton insecticides in India by half. It can also have a positive impact on the environment, economics of production and productivity and the health of up to 4 to 5 million small farmers growing cotton in India." The sowing for cotton in the north India begins in April-May. In south and central India, sowing beginS during May-June and in Tamil Nadu, it will be done in August. In case GEAC fails to give its nod for Mahyco's Bt cotton hybrids on time, then the farmers who have already tasted the fruits of the new technology will buy Bt cotton seeds from Rasi Seeds, a sub-licensee of MMB. "Besides Rasi Seeds, many seed companies have sub-licenses from MMB and are awaiting commercial approval for their own bollgard hybrids in this and subsequent years, "said Ranjana Smetacek, director, public affairs, Monsanto Holdings Pvt Ltd. "Seeing the positive trend in the acceptance of Bt cotton, the seed companies concerned have planned stocks adequately so that the farmers get the seeds without any problems at fixed price of Rs 1600 per packet," Smetacek observed. Nevertheless, the delay from the regulatory authority might encourage farmers to look at buying spurious/unauthenticated hybrid seeds from the grey market. The GEAC has already spent two months on the issue without arriving at a conclusion. This has only posed questions such as who would stand to gain in the tussle between GEAC and NGOs? Are pro-farmer organizations really concerned about the farmers' causes? Is this a lobby against the MNC/ new technology? Only time will tell. ]]> <![CDATA[SAS launches drug development 3.0]]> https://biospectrumindia.com/news/95/1132/sas-launches-drug-development-3-0.html https://biospectrumindia.com/news/95/1132/sas-launches-drug-development-3-0.html Tue, 10 May 2005 14:39:00 +0530 SAS, a leading company in business intelligence software and services, has launched SAS Drug Development 3.0. Based on the breakthrough capabilities of the SAS9 intelligence platform, SAS drug development provides a centralized repository that allows life sciences firms to analyze their clinical research for regulatory submission and explore new market opportunities, product line extensions and safety issues - all within a controlled and secure collaborative framework designed for life sciences research industries. SAS drug development has been designed to meet federal regulations such as 21 CFR Part 11, good industry practices and sound business practices. Commenting on the launch, Sudipta K Sen, managing director and CEO, SAS India said "Pharmaceutical companies in India are gearing to find out innovative ways to effectively manage, analyze, and explore massive amounts of complex data, and still minimize their time to market. SAS Drug Development provides an integrated system for managing, analyzing, reporting and reviewing clinical research information. The solution also allows companies to increase revenue potential, enhance the productivity of the clinical research team and improve clinical program investment decisions - all in an environment that facilitates regulatory compliance." ]]> <![CDATA["Lead optimization and drug develop ability key to success"]]> https://biospectrumindia.com/news/95/1712/lead-optimization-and-drug-develop-ability-key-to-success.html https://biospectrumindia.com/news/95/1712/lead-optimization-and-drug-develop-ability-key-to-success.html Tue, 10 May 2005 14:38:00 +0530 "Lead optimization and drug develop ability are the key to successful progression in drug development and to develop a molecule into a useful medical molecule," said Dr Vinod Shah, senior research scientist, US Food and Drug Administration. He was speaking at the third American Association of Pharmaceutical Scientists (AAPS) program in India on 'Drug discovery and development: challenges and opportunities for India'. Dr Shah noted that drug discovery and development is a game that must be played with skill and best judgment, otherwise drugs will fail to gain the market access. He said that if issues such as safety issues, toxicity, poor pharmaceutical properties, undesirable PK, lack of efficacy and marketing decision is taken care of, then there was no reason for the failure of the drug. ]]> <![CDATA[HP powers IGIB with supercomputer to accelerate research]]> https://biospectrumindia.com/news/95/2780/hp-powers-igib-with-supercomputer-to-accelerate-research.html https://biospectrumindia.com/news/95/2780/hp-powers-igib-with-supercomputer-to-accelerate-research.html Tue, 10 May 2005 14:37:00 +0530 The Institute of Genomics and Integrative Biology (IGIB), New Delhi, is engaged in setting up a super computer facility in collaboration with HP aimed at undertaking complex life sciences research With an objective of increasing the speed at which life science research is being done â€“ IGIB, a constituent of the Council of Scientific and Industrial Research (CSIR), has signed an agreement to acquire Hewlett-Packard (HP)'s four-teraflop cluster platform supercomputer for conducting advance life sciences computational biology research. "We are doing this in order to speed up the research process. HP's cluster platform provides a scalable architecture that allows us to complete large simulation experiments such as molecular interactions and dynamics, virtual drug screening and protein folding, much more quickly, saving a lot of time for us to do other complex things," Samir Brahmachari, Director, IGIB, informed. CyberMedia News ]]> <![CDATA[Ranbaxy, NCL and DST ink collaborative pact]]> https://biospectrumindia.com/news/95/1347/ranbaxy-ncl-and-dst-ink-collaborative-pact.html https://biospectrumindia.com/news/95/1347/ranbaxy-ncl-and-dst-ink-collaborative-pact.html Tue, 10 May 2005 14:36:00 +0530 Ranbaxy has entered into a collaborative agreement with the National Chemical Laboratories (NCL), Pune and the Department of Science & Technology (DST), New Delhi, in the area of New Drug Discovery. Ranbaxy and DST will jointly fund NCL, under the aegis of the Pharmaceuticals Research and Development Support Fund (PRDSF), to synthesize novel anti-infective drugs. The tripartite agreement was signed by Dr GS Samathanam, director, Department of Science & Technology, Government of India, New Delhi, Dr MK Gurjar, head and deputy director, Organic Chemistry Technology Division, NCL and Dr Kasim Mookhtiar, head, Drug Discovery, Ranbaxy. Commenting on the development, Dr Brian W Tempest, CEO and managing director, Ranbaxy, said, "We are pleased to join hands with NCL and DST in this program of collaborative research. I believe the combination will release powerful synergies that will lead to the discovery and development of new and innovative medicines to combat infectious diseases." ]]> <![CDATA[Shantha Biotech introduces Jencevac vaccine]]> https://biospectrumindia.com/news/95/2238/shantha-biotech-introduces-jencevac-vaccine.html https://biospectrumindia.com/news/95/2238/shantha-biotech-introduces-jencevac-vaccine.html Tue, 10 May 2005 14:11:00 +0530 Hyderabad-based Shantha Biotechnics has introduced Jencevac, a vaccine for combating Japanese Encephalitis (commonly known as brain fever) in the domestic market. Shantha Biotech has formed a partnership with Green Cross Vaccine Corporation, Korea, an international pharma company striving to provide worldwide to prophylactic vaccines, for distribution and marketing of Jencevac in India. Commenting on the launch, Varaprasad Reddy, managing director of Shantha Biotechnics, said "Jencevac is produced using the inactivated Nakayama strain known for its good propagation characteristics and its strength to provide cross-protection against other JE viral strains. With Jencevac, Shantha reiterates its dedication of providing excellent human healthcare products at affordable prices matched with good quality. JE vaccine is yet another step we have taken forward for fulfilling our mission of creating a healthy and ailment-free society." ]]> <![CDATA[Bhan favors permanent policy board]]> https://biospectrumindia.com/news/95/6905/bhan-favors-permanent-policy-board.html https://biospectrumindia.com/news/95/6905/bhan-favors-permanent-policy-board.html Tue, 10 May 2005 14:06:00 +0530 Dr MK Bhan, secretary, Department of Biotechnology has advocated the creation of a permanent policy board in the government to proactively look at new technologies that are coming in. He was speaking at a CII workshop on "Regulation of Biotech Crops: Going Beyond Single-Gene Products". Dr Bhan added that India's biotech regulation needed to be able to respond to broader issues, in addition to specific cases that came up for approval. He said that clearly articulated information from a neutral source would help the members of different committees that approve biotechnology products to take better decisions. This was needed since it was often difficult to separate information from advocacy. Earlier, speaking at the workshop, Dr Phillip J Eppard the regulatory affairs head for corn for Monsanto, USA explained how already biotech products were moving to a stage of having more than one trait for a single product, by successfully combining two different traits. He explained the approaches to the regulating such multi-gene products that different countries like Mexico, China, USA, Japan, and the EU followed. DD Verma, joint secretary, Ministry of Environment and Forests, Dr SR Gupta, deputy director general, PFA from the Ministry of Health and Dr CD Mayee, chairman of the agriculture scientists recruitment board, also spoke on the occasion. ]]> <![CDATA[Advanced Biochemicals opens office in China]]> https://biospectrumindia.com/news/95/2522/advanced-biochemicals-opens-office-in-china.html https://biospectrumindia.com/news/95/2522/advanced-biochemicals-opens-office-in-china.html Tue, 10 May 2005 13:33:00 +0530 Advanced Biochemicals Ltd, a sister company of Speciality Enzymes and Biochemicals Co, USA, sees a lot of opportunity in China for its enzymes and set up an office in the country. C L Rathi, managing director, Advanced Biochemicals Ltd said, "In Asia Pacific region we see a great opportunity in China for our industrial enzyme products. We have already opened an office in China and appointed an agent to study the various options such as setting up manufacturing facility, dealership and tie-ups. Based on the outcome of the study we will enter the market. The new office in China will allow help the company to serve its existing and new clients in Asia." ]]> <![CDATA[Polygenetics looking for partners]]> https://biospectrumindia.com/news/95/2831/polygenetics-looking-for-partners.html https://biospectrumindia.com/news/95/2831/polygenetics-looking-for-partners.html Tue, 10 May 2005 13:24:00 +0530 Polygenetics, a biomedical company based in the USA, is looking for partners in India for its technology on an application basis or on a drug-by-drug basis. James R Benson, chairman, Polygenetics who was in Mumbai recently for discussions with the Indian pharmaceutical companies said, "We are currently offering exclusive licensing rights to our patented polymer technology called CavilinkTM. Licensees can choose from several fields of use, depending on their market interests and market penetration. Under licensing arrangements, we would provide licensees rights to develop, manufacture, have manufactured, use and sell products covered by its patents for defined fields of use. Polygenetics can provide technology transfer and some training of personnel if appropriate." ]]> <![CDATA[Biocon Group crosses Rs 700 crore in revenues]]> https://biospectrumindia.com/news/95/1736/biocon-group-crosses-rs-700-crore-in-revenues.html https://biospectrumindia.com/news/95/1736/biocon-group-crosses-rs-700-crore-in-revenues.html Tue, 10 May 2005 13:13:00 +0530 Biocon announced its financial performance for the financial year ended March 31, 2005. While its total income increased by 34 percent to Rs 728 crore from Rs 542 crore in 2003-04, net profit grew 42 percent to Rs 198 crore from Rs 139 crore. The growth has come on account of strong performance of its biopharmaceuticals and custom research and services portfolio. Revenues from the biopharmaceuticals business improved by 28 percent to Rs 557 crore from Rs 435 crore the previous year, contributing to 77 percent of the total revenues in FY 2005. Revenues from custom and clinical research was higher by 70 percent to Rs 66 crore from Rs 39 crore. Kiran Mazumdar-Shaw, chairman and managing director, Biocon, commented: "All our key businesses - biopharmaceuticals, enzymes and research services demonstrated positive growth. The numbers reported have exceeded our internal profit targets. Given the increased capacity coming on stream in FY 2005-06, we are confident of achieving healthy sales growth, despite the pricing pressure on our Statins business. We will maintain current levels of operating margins. However, profit for the year ahead will not grow as fast as sales. This will be partly attributable to an increased depreciation charge on our new facilities which will cater to large US market opportunities for Simvastatin and Pravastatin emerging in 2006 but more importantly, the company plans to significantly increase R&D investments to support a discovery led research strategy. We believe this approach will deliver superior shareholder value over the medium and long term." Biocon has made significant progress in its collaborative in-licensed R&D programs - h-R3/cancer vaccines (with CIMAB), oral insulin (with Nobex) and human antibodies (Vaccinex). "We see these as rapidly developing into very large global opportunities over the next 3-4 years," added Shaw.   ]]> <![CDATA[BioEvents - May 2005]]> https://biospectrumindia.com/news/95/2357/bioevents-may-2005.html https://biospectrumindia.com/news/95/2357/bioevents-may-2005.html Tue, 10 May 2005 13:09:00 +0530 BIO 2005 Biotechnology Industry Organization's (BIO) 2005 Annual International Convention will be held at the Pennsylvania Convention Center in Philadelphia on June 19-22, 2005. This year's conference is hosted by the tri-state region of Pennsylvania, New Jersey, and Delaware. More than 18,000 biotech executives, investors, journalists, policy makers and scientists from more than 60 countries are expected to attend. The convention will feature greater overseas representation with two international plenary sessions, country seminars with 16 countries presenting the latest developments in national biotechnology policies, and a ministerial seminar with federal level ministers from at least four countries. BIO will host a record number of high ranking international dignitaries leading national delegations from more than 60 countries. For more details, contact: info@bio.org Bio-Collaborations Asia IBC Life Sciences will organize Bio-Collaborations Asia at the Boston Park Plaza Hotel, Boston, MA, on May 18-20, 2005. The conference will explore the issues relating to building and growing a pharmaceutical or biotechnology business in Asia. It will feature select case experiences of US and European companies who have ventured into Asia, either through joint venture, licensing or outsourcing collaborations. Conference speakers will examine the challenges, the tribulations and the successes of these partnerships. The conference will include focused sessions on IP and Regulatory concerns in China and India, value propositions for licensing, outsourcing and offshoring to Asia, best practices and case studies of successful collaborations between East and West. IBC in association with The Federation of Indian Chambers of Commerce and Industry (FICCI) will also organize a half-day "India Pharma Forum 2005" on May 18, 2005. For more details, contact: inq@ibcusa.com BIO VentureForum East 2005 The Biotechnology Industry Organization (BIO), in partnership with 12 state biotechnology associations and BIOTECanada will organize BIO VentureForum East 2005 at the Intercontinental Hotel-Buckhead, Atlanta, Georgia on May 9-11, 2005. The conference will bring venture capitalists together with promising seed, early- and late-stage private biotechnology product and platform companies from the East Coast. It will showcase 120 individual company presentations to leading North American venture capital firms in the life sciences field. Workshops and plenary sessions will be offered on trends in the biotech industry, with special focus on key success factors for early stage companies, R&D, market trends, and financing. In addition, there will be formal and informal networking opportunities with industry CEOs and venture capital leaders. To ensure high quality deal flow, an advisory board made up of 30 equity capital leaders, will review and evaluate the corporate profiles of companies through an application process. Selected entrepreneurs will also attend regional BIO Venture Forum Boot Camps. For more details, contact: gbutera@bio.org or ccook@bio.org PABORD 2005 PABORD 2005, a pharmaceutical and biotech outsourcing, research and development exhibition and conference, will be held in London on September 14-15, 2005. The event will focus exclusively on the theme of outsourcing in the research and development of new medicines. Companies both large and small are adopting this increasingly popular business strategy. The conference is relevant to service providers and R&D organizations active across the entire discovery and development chain from lead generation to product registration. For more details, contact: info@pabord.com Drug Discovery & Development Asia-Pacific meet IBC will organize Drug Discovery & Development Asia-Pacific conference on June 1-3, 2005 in Singapore. The conference will take an in-depth look at the innovative progress being made by various Asia-Pacific countries. Conference speakers will present case studies of successful East-West collaboration and lessons learned in the Asian market, as well as deliver scientific updates on disease-specific drug discovery and research. Be it information on innovative scientific updates or search for outsourcing opportunities such as finding new molecules to in-license or forming research partnerships, this conference will have it all. For more details, contact: enquiry@ibcasia.com.sg Drug Delivery World meet Drug Delivery World, a three-day conference which will be organized by IBC Life Sciences on May 16, 2005 in CA, USA, will serve as a targeted educational platform for leaders in the drug delivery field to assess technology, foster strategic relationships, find more effective ways to extend product lifecycles, and optimize the pipeline through compound-enabling programs. The meet will include three panel discussions and two in-depth tracks on business and technology to help pharmaceutical professionals build new relationships and address the growing number of delivery options available within the industry. Panel discussions will focus on building true alliances, advanced transdermal products, and fast dissolve ODT technologies. For more details, contact: ecray@ibcusa.com RELATENZ 2005 RELATENZ 2005, an international conference on enzyme technology will be held on September 20- 23, 2005 at the University of Matanzas, Cuba. The meet will emphasize on current developments on basic and applied enzymology enzyme structure and function, biocatalysis, enzyme immobilization and stabilization. The meet will feature plenary lectures, session lectures, oral communications and poster sessions on enzymes in biotechnological, industrial, agricultural and environmental applications. For further details, contact: relatenz.umcc@umcc.cu Phacilitate Vaccine Forum Spring 2005 Phacilitate's fourth annual Spring Vaccine Forum will be held on May 23-25, 2005 in Amsterdam, Netherlands. The conference will provide an opportunity for leaders from across the vaccines sector to meet, and to discuss solutions to their common strategic, regulatory and technological challenges. The three-day conference will feature plenary presentations, workshops, breakout sessions and panel discussions. For more information, contact: david@phacilitate.co.uk Therapeutics Conference The IIR will organize a three-day conference on Immunogenicity for Protein-based Therapeutics on May 23, 2005 in San Franciso, CA, USA. This 6th annual conference will provide new data on assay development and validation, screening and neutralizing assays, coupled with a concentration on the latest process techniques and technological advancements through all new, original case studies. As the conference has developed and grown, IIR has recognized the challenges faced by scientists working in immunogenicity and provided the first forum to exclusively address immunogenicity issues. For the first four years, it focused primarily on the antibody immunogenicity for biologics and vaccines. Beginning in 2004, and continuing through this year, it has expanded the agenda to include the latest cell based bioassay validation, screening and neutralizing assays, and improvement in processes and techniques. For more details, contact Anne Moyer, e-mail: amoyer@iirusa.com ]]> <![CDATA[Promising Future Ahead For Indian Diagnostics Market]]> https://biospectrumindia.com/news/95/2368/promising-future-ahead-for-indian-diagnostics-market.html https://biospectrumindia.com/news/95/2368/promising-future-ahead-for-indian-diagnostics-market.html Tue, 10 May 2005 13:05:00 +0530 The major factor boosting the growth of the diagnostic market in India is the cost advantage that Indian laboratories offer over countries like the USA. The manufacture of diagnostic kits and reagents in India is a relatively new segment in the healthcare industry. At present India has about 25 companies manufacturing diagnostic kits. These diagnostic companies are manufacturing and selling kits mainly in the areas of pregnancy, ovulation, estimation of T3, T4 & TSH, HIV, HBV and HCV infection, rheumatoid diseases and disorders, cancer (cervix, colon, prostate, lung, mouth etc.), kidney function and liver function. There has been an increase in the utilization of diagnostic devices and tests in last few years. This is mainly due to increased awareness about healthcare, hike in the pay packages of the middle class families in the urban India, health insurance schemes are also driving the utilization of diagnostics kits in the country. The number of tests conducted in the last decade has doubled from 180 million to over 400 million. There are over 11,500 hospitals and 14,000 diagnostic laboratories in the country that utilize large volumes of diagnostics. The major factor that is driving the growth of manufacturing of diagnostic kits in India is the 70-80 percent cost advantage that Indian laboratories offer over countries like the USA. Considering the demand for diagnostic kits and reagents against supply, the country has no other way but to look for imports. As noted earlier, only a handful of companies have manufacturing facilities in the country and most of the demand is met through imports. If we look at the diagnostic market ratio of import vs indigenous, it is quite interesting. In 1976 there were only two major players in diagnostics and they are Ortho Diagnostics, a division of Johnson & Johnson, Mumbai and Span Diagnostics, Surat. The ratio may be approximately five percent indigenous as against 95 percent imported. Today the situation is totally different. About 25 manufacturers with an ultra modern manufacturing facilities are registered with global technology. The Indian companies have been manufacturing kits for blood grouping, serology, clinical chemistry, pregnancy detection, HIV detection and other Rapid tests that are accepted globally and imports of such products are negligible in finished form. "I think it is the "Made in India" stigma. Now we have very good Indian companies making good quality products meeting global standards but we still face problems in convincing labs and institutions in the country to use kits manufactured by Indian companies." - Dr Shama Bhat, managing director, Bhat Biotech India (P) Ltd noted, "Today the diagnostics business is mainly based on technology. The Indian companies with their R&D facilities have developed a range of good quality products for the local market with such competitiveness that imported kits cannot stand in the market. However, there are a few hi-tech products like Elisa, PCR, a few cancer markers and many other products for which there are very few manufacturers in the country. This area is also developing very fast. At present these products are being imported. In the coming days, the Indian diagnostics industry will surely develop this technology and make the products available locally," said Dr D K Joshi, managing director, Beacon Diagnostics Pvt Ltd. Sharing similar views Suresh Vazirani, managing director, Transasia Bio- Medicals Ltd, said, "A large number of instruments are based on proprietary reagents due to the closed system. Besides, indigenous developments have received thrust only in recent years but the trends are encouraging and we can hope there is a reduction in imports in the coming years." Ramesh Chakraborty, area manager, Rapid Diagnostic Pvt Ltd noted that the price, quality and availability are still driving the imports of diagnostic kits into India. However, M J Dashora, managing director, Accurex Biomedicals Ltd has different views on on India's dependency on diagnostics imports. He said, " India still doesn't have the infrastructure to manufacture diagnostic kits. I strongly feel that patriotic feelings are missing among Indians. Students with specialization in biochemistry, molecular biology are looking for options outside India. These are some of the factors which have led to India still depending on imports." Dr Shama Bhat, managing director, Bhat Biotech India (P) Ltd noted, "I think it is the "Made in India" stigma. Now we have very good Indian companies making good quality products meeting global standards but we still face problems in convincing labs and institutions in the country to use kits manufactured by Indian companies." Presence of pharma players In addition to diagnostic manufacturers, we find the presence of the big pharmaceutical companies in this space. It is making all the difference to small and medium players. These big pharmaceutical companies, most of which are not into manufacturing kits, are driving the business in high volumes at lesser margins. This has created problems for local manufacturers who depend on import of raw materials at high costs. "The big pharmaceutical companies are still in diagnostics business because both pharma and diagnostic sectors are related to health. Now more rapid test products are available for diagnosis. It is easy for the pharmaceutical companies to sell the diagnostic kits through their huge market network and also make profits," said Ramesh Chakraborty. "There is good scope for the diagnostics business in India due to increasing awareness among the public in rural areas. When these products reach small towns and villages, the utilization and demand will increase," - Umesh Kaushik, operational manager, Nano Biotech P Ltd. Sharing his long experience in the field of diagnostics, Dr D K Joshi observed that the big pharmaceutical companies have not been successful in the diagnostics market. He has a reason to say so. "In my view, compared to the pharmaceutical market which is estimated to be worth Rs 50,000 crore, the diagnostics market which is estimated to be worth Rs 800 crore, is a very small market for pharmaceutical companies. To operate in a diagnostics market, a company requires highly trained staff which is very expensive. The diagnostics market requires "after sales service" and it is purely based on continuous quality supply. Keeping these facts in mind, for a big pharmaceutical company there will be a greater operational cost against the revenues generated which is not feasible. Hence there is no lucrative margin or profit in this business." Expressing similar views Dr Shama Bhat said, "Companies like Dr Reddy's Labs, Nicholas Piramal and Merind are not doing business in the diagnostics space. Some of the leading companies like Ranbaxy are also considering shifting their focus on the pharmaceutical side." Market scenario According to the Confederation of Indian Industry (CII), the market for diagnostics in India stood at about $100 million during 1997 and it is estimated to reach $200 million by the end of this year. Around 50 percent of the demand is met by imports. The total Indian diagnostics market in 2003-04 stood at Rs 260 crore and accounted for 10 percent of biopharmaceutical sector sales. The segment grew by about 46 percent over the previous year. The size of the immunodiagnostics market is expected to increase by four to five times. Monoclonal and polyclonal antibodies for disease immunodiagnosis, tissue typing, clinical assays and research constitute a huge portion of the market. Immunology, kits for pregnancy detection, blood grouping, amoebiasis, filariasis. leishmaniasis, typhoid, hepatitis B, HIV, TB and malaria have been developed locally and capture a small portion of the diagnostics arena. Government support The National Biotechnology Development Strategy of the Department of Biotechnology, Government of India, has talked about the diagnostics for emerging medical paradigm in the sectoral road map and also suggested some strategic actions for the sector. The strategic actions include establishing a cell for diagnostic biotechnology to encourage and support studies into the clinical application of pharmacogenomics. This cell should be well positioned to overcome barriers in its work to bring pharmacogenomics to the clinical setting; encourage research involving investigators with both clinical practice and pharmacology/ pharmacokinetics expertise while at the same time keeping the overall goal of clinical application/utility in focus; provide incentives for this group of clinician-researchers to bring these scientific advances to the patient bedside; support education programs to providers of the importance of this field and its utility; encourage biopharmaceutical companies to include pharmacogenomic data in their drug submissions. According to Dashora of Accurex Biomedicals, " It is very difficult to determine the exact size of the diagnostics market in India. It involves different segments such as home segment, urine chemistry, diagnostic kits, and reagents. If we consider only diagnostic kits and urine chemistry, the market size will be about Rs 200 crore. Even Chinese kits are available in plenty in the grey market in Bhagirathi area of Delhi. Therefore it is very difficult to estimate the size of the diagnostics market in India." Industry people from across the country have come up with different figures on the size of the market. According to Ramesh Chakraborty, the market is around Rs 500 crore. Suresh Vazirani has different figure. He said it would be over Rs 1100 crore. Dr Shama Bhat said, "It is about Rs 1500 crore excluding the instruments such as MRI and catscan." Dr Ravi Kumar, managing director of XCyton Diagnostics noted that at present the Indian diagnostic market was about Rs 250 crore for a population of over 100 crore. Hence, as rightly pointed out by Dashora, it is very difficult to estimate the size of the Indian diagnostic sector. Contrary to the above reports, Dr D K Joshi said, "The Indian diagnostics market can be categorized into two major categories - one is the reagents and allied business and the other is the instruments business. Considering the overall business of diagnostics in the reagents and allied category, the approximate size of the market is about Rs 800 crore. For instruments, the market is bigger than reagents. But I do not have any exact idea or I do not have any exact data available with me. If we look at the markets in western countries, the diagnostics reagents market ratio is on an average of 12 to 15 percent of the pharmaceutical market, but in India it is approximately 2 percent of the pharmaceutical market." ADMI â€“ driving the diagnostic sector About 19 diagnostic manufacturers - both Indian and multinational companies have joined hands and decided to work together for the growth of the sector and also wellness of the public health. They formed an association called the Association of Diagnostic Manufacturers of India (ADMI) in January 2002. The main objective of ADMI is to appraise the government (state as well as Central) about the difficulties and bottlenecks faced by the diagnostics industry with as view to ensure healthy growth of this industry. In general, the ADMI maintains a close liaison with Drug Control Administration and the National Institute of Biologicals to ensure proper compliance of regulatory requirement prescribed under Drug Rules by it members. Dr P K Desai, president of ADMI said, "We have been working very closely with the government on many issues. We have represented and convinced the Drug Controller General of India to design and implement an uniform licensing policy for the diagnostics industry in the country. We have also made representations to the finance department to include Hepatitis C test kit in the life saving list so as to exempt it from excise duty." Dr Desai further noted that the GMP requirement and Inspection Report for FDA were prepared jointly by a working group committee comprising officers from the Drug Control Department and industry experts who worked together and prepared official document of GMP, which is now duly published by the Drug Controller General of India. Besides organizing lecture series for its members by a renowned expert in the field of IPR-related matters, the ADMI had made a representation to the VAT committee for implementing uniform VAT tariff for diagnostics throughout the country, at par with that applicable to drugs and medicines. The ADMI has made a representation to the finance ministry for classification of diagnostic product as per HSN guidelines for the purpose of excise as well as customs tariff. The business of diagnostic products is increasing very rapidly at an approximate rate of 15-20 percent growth per annum in India. Though there is presence of diagnostics manufacturing units in the country, the demand for products like rapid tests, ELISA and biochemical kits are met by imports. "There is good scope for the diagnostics business in India due to increasing awareness among the public in rural areas. When these products reach small towns and villages, the utilization and demand will increase," observed Umesh Kaushik, operational manager, Nano Biotech P Ltd. Stumbling blocks Although there is an investment opportunity for local production, it is yet to be tapped to its fullest potential. At present, more than half of the diagnostic kits are imported at higher cost and are often ineffective as they are not designed for Indian climatic conditions or variant Indian strains of microbes. Substitutes for these would be an excellent opportunity. There is a market at both national and international levels for diagnostic kits. But a beginning has to be made in a small way by overcoming problems facing the sector. "High import duty and custom clearance procedures, competition, logistics, lack of knowledge, licensing, slow pace of approvals from statutory authorities, lack of national laboratory network for evaluation and approval of new products are some of the factors slowing down the pace of indigenisation, "noted Suresh Vazirani. Elaborating on the lack of proper guidelines in this niche market, Umesh Kaushik said, "There are no standard guidelines to grant license for manufacturing diagnostic products and for the approval of all ranges of products (for either imported or products manufactured in India). These vary from state to state. There is also no special package and exemption in taxes from the government for establishing diagnostic manufacturing units. The number of cheaper and efficient technology transfers in the area of diagnostics is limited." Expressing anguish Dr Shama Bhat said, "Regulatory issues and corrupt consumers have crippled the growth of local diagnostic companies. I mean to say that the corruption in India is not just restricted to the government staff. It has spread its tentacles into the private sector too. People do not mind discarding good company for petty personal gains, particularly the lab technicians and purchasing officers. Coupled with this is the lack of qualified technicians which makes it difficult to sell new products to small to medium labs." Red tapism, lack of strong will power to remain in the business of diagnostics, regulatory confusion and lesser margins are some of the issues confronting the growth of the segment. Moreover, as the segment is very small, it is difficult to drive the struggle. Importing raw materials at high cost is also a major issue facing the segment. To take up these issues with government bodies, all the leading manufacturers of diagnostic kits in India have come together under a banner called the Association of Diagnostic Manufacturers of India (ADMI). It has been actively working to promote the segment. ADMI in its short stint has already made many representations to government bodies. Opportunity versus lack of market knowledge In spite of growing market and opportunity, entrepreneurs are not looking at the diagnostics market as a lucrative sector. Industry people observed that entrepreneurs do not have sufficient knowledge about the range of products and the market that they have. Even the complex nature of the manufacturing process is coming in their way. "The industry being fragmented and due to lack of knowledge, the entrepreneurs will have to make a lot of efforts to develop the market and make it a non-viable one, " said Vazirani. Diagnostic manufacturers in India  Accurex Agappe Diagnostics Amar Immunodiagnostics Bayer Diagnostics India Limited Beacon Diagnostics Pvt Ltd Bhat Biotech India (P) Ltd Biolab Diagnostics Fairdeal Diagnostics J. Mitra & Co Ltd Labcare Diagnostics Pvt Ltd Mediclone Biotech Pvt Ltd  Medtek Asia Pvt Ltd Monozyme India Limited Ranbaxy Diagnostics Reckon Diagnostics Pvt Ltd Span Diagnostics Transasia Bio Medicals Ltd Transgeniks  Tulip Diagnostics (P) Ltd   Importers of diagnostic kits in India  Abbott Healthcare Pvt Ltd  Amar Immunodiagnostics  Applica Bio-Diagnostic  Arun & Co Biomerieux India Pvt Ltd  Bio-Red Laboratories (India) Pvt Ltd  Cambindia Biotech Kits (Pvt) Ltd Erza Brothers Genetech Diagnostic Pvt Ltd  Indotech  Johnson & Johnson Ltd LG Chemical India Pvt Ltd  Lilac Medicare  Monozyme India Ltd  Morepen Labs Ltd Qualigens Fine Chemicals Ranbaxy Diagnostics  Ranbaxy Laboratories Ltd Rapid Diagnostics Pvt Ltd  Roche Diagnostics India Pvt Ltd Ruchi Corporation  Saxsons Biotech Pvt Ltd Spectra Pharma & Health Products  Suyog Diagnostics Pvt Ltd  Transasia Bio-Medicals Ltd  Vector Biotech Pvt Ltd  Source: Central Drugs Standards Control Organisation (CDSCO) "The diagnostics market involves laborious work. It is more demanding. One has to take up bigger challenges. Quality is the key factor in this small and niche market. Lack of skilled and technical talents to handle, push the entrepreneurs to surrender instead of facing challenges. And finally they end up making losses owing to many reasons," said Dashora. Dr Joshi shared similar views. He said the sector required a great degree of expertise and the the size of the total market was very small. And hence people do not find it to be a very profitable business, he felt. However, the fact remains that diagnostics is one of the major investment opportunities in the healthcare industry. India's large population base has created a huge demand for immunology kits for pregnancy detection, HIV, TB and malaria. Further, there is an increased utilization of diagnostic devices and tests in public hospitals. Recognizing the opportunity, the Government of Gujarat is encouraging private players to set up a facility for manufacturing of diagnostic kits in the state. The unit can focus on the manufacturing of diagnostic kits for humans, animals, plants or fisheries. The different diagnostic areas include immunoassay, clinical chemistry and hematology. At present about 25 companies are into manufacturing diagnostic kits in India. These include Accurex Biomedicals, Beacon Diagnostics, Bhat Biotech, Bio-systems Diagnostics J Mitra & Co, Monozyme India, Span Diagnostics Ltd, Transasia Biomedicals, Tulip Group and XCyton Diagnostics. The Department of Biotechnology (DBT) has been facilitating the transfer of many technologies for diagnostic kits to the industry developed at the CSIR labs. In India, there is still a gap between the industry and academia. India needs to work towards enhancing public-private partnership. This will result in proper utilization of public funds and more technology transfer. Umesh Kaushik noted that there is scope for new companies venturing into manufacturing diagnostic products. Many companies are seeking technology transfers of foreign and in-house developed technologies for diagnostic manufacturing in India. The existing manufacturers are also upgrading their manufacturing facilities and increasing the number of products. Owing to globalization, more and more kits will be entering the Indian market. The current market will grow manifold in the next few years. New and emerging technologies will also be introduced. Albeit margins being low, the diagnostic market is growing at a healthy rate and increase in spending on healthcare both by the government and individuals has shown a promising future ahead for the diagnostic kits market in India. Narayan Kulkarni with inputs from Rolly Dureha   ]]> <![CDATA[Bioinformatics and Legal Challenges]]> https://biospectrumindia.com/news/95/5357/bioinformatics-and-legal-challenges.html https://biospectrumindia.com/news/95/5357/bioinformatics-and-legal-challenges.html Tue, 10 May 2005 13:03:00 +0530 The legal system does have and will continue to have an impact on bioinformatics. Bioinformatics is the use of computers to store, retrieve, analyze or predict the sequence or structure of biological information. It combines aspects of mathematics, statistics, computer science, and biology within a given set of partly discovered biological rules and IT solutions. The global bioinformatics market was valued at around $697 million in 2001 and is expected to increase to around $1.7 billion by 2006. There are three areas of opportunities in bioinformatics for India. At the highest level is the integrated research application service providers. Then there are the providers of data base services and discovery software. The software requirements of the biotech industry includes micro array analysis, database software, sequence analysis, visualization software, array management and testing in silico. Legal issues As opportunities increase, more and more businesses will find themselves contemplating transactions relating to bioinformatics. Fully protecting your company requires not only an understanding of the technology involved but the special legal issues involved with bioinformatics-related transactions. When negotiating a software transaction, companies should typically focus on such provisions as acceptance testing, service level agreements, upgrades and enhancements, confidentiality, ownership and licensing rights between the parties. Because of the newness and complexity of the hardware and software geared specifically to the bioinformatics field, these transactions may also include a collaboration between the vendor of the hardware or software and the purchaser or licensee. In these cases, it is critical that intellectual property ownership be addressed upfront during the negotiations. Legal issues relating to bioinformatics transactions, especially in the realm of data, however, go beyond what has been described. In the case of representing a lab or drug company, companies should conduct due diligence by investigating a software vendor's use and ownership rights in the software applications it intends to license. The company should also keep in mind other contractual protections such as representations, warranties, indemnifications, and limitation on liabilities when it pertains to any software at issues. Bioinformatics & Intellectual Property In India, the intellectual property rights of computer software is covered under the Copyright Law as software is not yet permitted to be patented. It is important for bioinformatics companies to ensure that their IP is protected. There are basically two aspects to the bioinformatics industry: services component and; software used by such companies With respect to the IP issues for bioinformatics companies, there is a need to protect all information being provided to the company by the sponsor. There is also a need for all bioinformatics companies to have an IP game plan. This will largely consist of deciding to protect your intellectual property through statutory means (copyright and trademark) or through contractual means. In an ideal situation, it should be a combination of both. While this relatively new field offers compelling opportunities, companies need to consider the many issues in bioinformatics transactions beyond the usual hardware and software concerns, including issues involving privacy and restrictions on related intellectual property. Kirit S Javali advocates@jafajavali.com Law Offices of Jafa & Javali is a full fledged Corporate law firm with niche expertise in IPR & Biotech law, with offices in New Delhi, Bangalore and Mumbai. ]]> <![CDATA[GM Crops and Biodiversity: What]]> https://biospectrumindia.com/news/95/1579/gm-crops-and-biodiversity-what.html https://biospectrumindia.com/news/95/1579/gm-crops-and-biodiversity-what.html Tue, 10 May 2005 12:54:00 +0530 Anti-GM crop activists are of the strong belief that GM crops pose a threat to biodiversity but this is far from truth and is yet to be proven scientifically. The modern agricultural economy dictates that farmers grow only those crops that would fetch decent returns (not always the case!). All of this is not a rocket science to those who are intimately involved in agricultural research of one kind or another. But, the general public does not understand these things very well and need not. They have left it to the experts to take care of the matter. How effectively these matters are being addressed by experts is also questioned by many. But, unless proper public policy instruments are in place, there is very little that experts can do to help protect biodiversity. Full blown activism is underway around the world to change policies that can help protect biodiversity. But, any such activism in the policy arena necessarily becomes political and things don't change very easily. But, that is the price we have to pay in this day and age for cherishing democratic pluralism. A 10,000-year-old human activity like agriculture will not change quickly. Any practical solution to conserve biodiversity will have to come from modern science and technology, and not by activism and harping against GMOs. Modern plant breeding and biotechnology have already proved that they can play a useful role. There are always trade-offs, but the critics of biotechnology single out GM crops as the villain of the situation, and would like to stop GM crops in its tracks to save the precious biodiversity without proving how they are directly responsible for the destruction of biodiversity. Many of them want to go back to diversification of crop varieties of the yore and restore the glorious romantic agricultural past where every homestead grew little of everything needed and take care of all the community's needs and just be one happy family. How realistic is this? We can neither go back to the past nor can we ask poor farmers of the developing world to grow uneconomical varieties. That will be a crime against humanity. Certainly, we all need to protect that precious biodiversity and protect it using modern science and technology and there is nothing better than modern biotechnology to do so. But, it is ludicrous to suggest that GM crops destroy biodiversity any more than any other introduced crops. "Gene pollution" and "genetic contamination" from GM crops are merely scaremongering tactics. One must realize that there must be an economic incentive for farmers to maintain on farm biodiversity; otherwise they have no reason to conserve the biodiversity to the benefit of few environmental romantics. Protecting biodiversity for the sake of biodiversity without benefiting from it in a sustainable manner will never work and has never worked. Many eulogize a tattered, poor farmer as a primary conserver of biodiversity. There is no reason why a poor and hungry farmer must cling on to non-productive old varieties just so that the urban NGOs and activists can feel good about it. What does he get in return? Is not it better for a scientific organization to collect all that biodiversity, characterize them and maintain both for posterity and also for use by future generations if they tap any benefit from them. That is what FAO is doing by organizing the Global Trust. Yes, it is going to cost money and money must be spent for that yeoman purpose, and all NGOs fighting for conservation of biodiversity must get on the case of their host governments to support this international effort. And, that would be a good case of meaningful activism. The cause celebre of the critics of GM crops is the introduction of GMOs into the centers of origin and diversity. They constantly invoke the infamous case of Bt maize gene escaping into certain land races of maize in the highlands of Oxaca, Mexico. All hell broke loose when it was first reported in a scientific report in the prestigious science magazine Nature. There were so many grandiose claims of loss of land races to genetic contamination to gene pollution to loss of agricultural spirituality of pastoral people in the highlands of Mexico. The fact is Bt genes did escape into land races because those farmers just did what they always did to preserve their delicate land races. They just used some of the Bt maize seeds and crossed them into land races (creolilization). This was happening all along the way and GM maize happens to be the villain this time because some people don't like GM crops. Now did this destroy maize land races? The answer is an emphatic NO, and it has been certified by the world's leading research institute on maize CIMMYT located right in Mexico. In fact, there is not a single instance of any wild or weedy relative having been reduced or destroyed by any newly introduced crop variety much less GM crops. But, for the critics it is "genetic pollution" or "genetic contamination" as if biodiversity was some how a virgin all this time, a complete scientific nonsense! CIMMYT did a thorough investigation of all its world collection of maize in their gene bank, and proved that there has been no contamination at all. But, activists never accept it and keep on stirring the pot so much so that FAO with the help of CGIAR has launched another multi-million exercise to discuss all the pros and cons of GMOs threat to germplasm collections around the world. That same funding could have been used to fund the much needed research that helps improve many of the subsistence crops and animals that badly need improvement. This is wastage of precious funding entirely due to the misguided activism. If one can visualize a pathway of gene flow from a GM crop to a wild or weedy relative anyone with basic a understanding of biology would know that gene flow in plants is via pollen and that pollen has to be viable in transit, effectively pollinate (through any number of known ways of pollination), and the genes have to be fixed in the new population over several generations with selection pressure. Then the question is so what if a Bt-gene or any other introduced gene from GM crop really gets fixed in a non-target population (biodiversity). By all reckoning, hundreds and thousands of genes are being introduced into crops through breeding are all known and determined to be beneficial and there is no evidence of these genes causing any harm to the non-target crop wild or weedy. On the other hand, they all enhance genetic diversity. In the context of GM opposition, somehow this wonderful natural gene flow is considered dangerous! Genes have been flowing as long as there have been living organisms on the planet, and we should all be thankful for it. Gene flow is the very essence of biodiversity. We should be praying for more of it, and not less. Humans have mediated gene flow all throughout the course of agricultural history and what biotechnologists are doing today is an improved and refined way of doing the same. There is no newly invented villainy here. It is once again sheer scientific nonsense to single out GM crops as a threat to biodiversity and prevent their gene flow. Genes flow in all directions. These critics of GM crops do not seem to have considered that genes from surrounding wild and weedy plants also flow into cultivated crops. That process equally destroys genetic purity of advanced varieties and can potentially lose their market and agronomic value (contra-indication!). In fact, plant breeders have been doing just that selectively for genetic improvement of crops. To preserve and to enhance biodiversity must be an important goal for everyone. By all reckoning, biotechnology can help by providing for new and novel approaches. GM crops are just like any other introduced crop variety designed for a beneficial or utilitarian purpose, and would have no more or less significant impact on either on-farm biodiversity or wild biodiversity. If genes that might have flown from cultivated plants into surrounding biodiversity all these years has not done any demonstrable or observed damage to biodiversity, how on earth GM crop pollen would destroy biodiversity now? The same can be said of any changes to agricultural practices associated with GM crops. All other arguments to the contrary are sheer a scientific hog wash, and nothing but an attempt scare people into banning GM crops which might otherwise be useful to farmers and consumers. Surely, all introduced crops must be monitored and GM crops are no exception to see what unexpected effects might occur on the agricultural landscape.But scientific and technological quest for improving the moribund agriculture in developing countries must go on as it is the only hope. That biodiversity will be destroyed by GM crops is nothing but an urban myth, and be dismissed as a scientific nonsense. Shanthu Shantharam Biologistics International, Ellicott City, MD, USA sshantharam@biologistics.us (Concluded) ]]> <![CDATA[Biotech Industry Consolidates]]> https://biospectrumindia.com/news/95/1518/biotech-industry-consolidates.html https://biospectrumindia.com/news/95/1518/biotech-industry-consolidates.html Tue, 10 May 2005 12:49:00 +0530 The UK leads in the European biotech race. The year 2003 saw consolidation of the industry for sustainable growth. T he bioscience industry is a British success story, notes Prime Minister Tony Blair in his foreword to Bioscience 2015 report. Britain has a track of excellent scientific discovery, which is the major factor contributing to the success of the biotech industry. According to a recently published report, Comparative Statistics for the UK, European and US Biotechnology Sectors-Analysis Year 2003, prepared by independent consultants, Critical I Ltd, for the Department of Trade and Industry (DTI), the UK is more sustainable in future than elsewhere in Europe and that the UK remains the most attractive for large investment. The report had found a general fall across Europe in biotech business activity due to widespread waves of restructuring. The study shows that at the end of 2003, Europe's biotechnology industry employed approximately 82,400 people and generated â‚¬16.3 billion of revenue. Europe's biotechnology sector had over 420 new drugs in clinical development or awaiting approval. European companies raised â‚¬1.3 billion of equity investment in 2003. And the UK was the single biggest contributor to these figures. In 2003, the UK sector's companies employed approximately 22,400 people and generated revenue of £3.6 billion. The UK companies had 224 new drugs in clinical development or awaiting approval-half of the European total. The UK companies raised £392 million of equity investment. The UK biotechnology sector had witnessed a restructuring process in 2002 and this process continued through 2003. The report indicates that the UK, post-restructuring, has the most robust biotechnology sector in Europe and remains the most likely national sector to attract the large equity investments necessary for growth. The report was published at a DTI led Science and Innovation Conference in Manchester that bought together key figures in business and academia in the North West to discuss the importance of driving forward innovation. Speaking at the conference, Science Minister Lord Sainsbury said, "Innovation is key to our economic success, as we increasingly compete against countries with significantly lower labor costs and well-educated labor forces. British businesses will only be able to compete in the global economy if more resources are moved from low to high value-added areas. This is highlighted in the UK's biotechnology sector which, despite a general global slowdown, remains the most successful and sustainable in Europe, second in the world only to the US." M&As dominate During 2003, the UK was the focus of some very high profile mergers and acquisitions like the acquisition of PowderJect Pharmaceuticals' profitable vaccines business by Chiron and Celltech acquiring OGS. British M&A activity accounted for 15 companies disappearing from the country count in 2003. During 2003, 75 UK companies were removed from the UK company counts as a result of losing their discrete identity through being absorbed in to another business operation through merger or acquisition, going out of business, or by becoming dormant. Meanwhile 36 new biotech companies were founded in the UK during 2003. Not surprisingly, the Healthcare group, with 20 foundings, was the largest, accompanied by 11 new companies planning to provide services such as bioprocessing, biomanufacturing and custom research activities and only four offering technology platforms. The UK also spawned with six companies planning to develop and sell healthcare diagnostics. No new companies emerged in the agricultural and marine biotechnology sector whilst the industrial and environmental sector saw only one new company formed in 2003. Robust VC support The UK sector raised more equity in 2003 than any other European country. And the venture capital support for the UK biotech sector remained relatively robust. The â‚¬247 million raised was, however, 20 percent below that raised in 2002, a fall pretty much in line with that across Europe as a whole. This sum was invested in 34 companies, all but two of which were in healthcare. Eighteen percent of this sum was raised by companies under two years old and 75percent by those between three and five years old. In 2002, by comparison, â‚¬335 million of venture capital was raised by 38 UK companies. A quarter of the companies were in the service provider and technology service provider categories. R&D focused According to the British high commissioner to India Sir Michael Arthur, the UK conducts 4.5 percent of the world's science and produces 8 percent of the world's scientific papers. And by 2008, the UK government will invest £5 billion per year. "Our government recently announced £2.5 billion budget allocation for biotech," Sir Arthur noted. Critical I has analyzed the R&D effort in the biotechnology sector in two main ways. It used an extrapolation approach to calculate figures for R&D spending and the number of R&D employees across all companies in its survey. The UK biotechnology sector's 2003 R&D spend was â‚¬1.76 billion (£1.24 billion). The healthcare sector with a total spend of â‚¬1.53 billion (£1.08 billion) represented the most significant contribution to R&D spending. More products developed The UK is a dominant player in European therapeutic product development. In 2003, UK Healthcare sector companies had 132 approved compounds on the market, 10 more than in 2002. This is almost half of the 263 marketed compounds developed by European biotechnology companies covered in the Critical I study. At the end of 2003, the UK companies also had a further 24 products, 80 percent of the European total, awaiting approval. Also in the drug development process, the UK accounted for 60 percent of the compounds among European companies surveyed in clinical phase III, 50 percent of those in clinical phase II, and around 45 percent of those in clinical phase I. Not just that. The UK is also well-placed within the European context when it comes to the future value of its pipeline. At the end of 2003, the UK Healthcare sector had 200 compounds in clinical development, 35 of which were in phase III. Switzerland, with 12 compounds in phase III and 29 others in the clinic was the UK's nearest competition, the report pointed out. The US biotechnology companies at the end of 2003 boasted 740 products on the market compared with the UK and European totals of 132 and 261 respectively. Robust revenues The companies surveyed in the Critical I generated â‚¬5 billion (£3.6 billion) in revenues. The UK agricultural and marine biotechnology revenues increased by 2.5 percent to â‚¬543 million (£383 million) in the two years to 2003. The industrial and environmental sector revenues were £114.2 million (â‚¬131m) compared to £99 million (â‚¬162 million) in 2001, a 15 percent increase over the period. The healthcare companies generated revenues of â‚¬12.4 billion in 2003, almost three-quarters of total European biotech revenues that year. UK companies accounted for â‚¬3.5 billion of this sum. The service provider revenues increased â‚¬800 million in 2003. The future, according to the industry experts, is that the UK biotech is on a robust path. The sector, like that of the US, is relatively highly dependent on equity investment. It is particularly important for companies to be able to raise finance between â‚¬10-30 million, a range that allows them to continue to tread the value-generating road to product development. Information Source: Critical I Report on Comparative Statistics for the UK, European and US Biotechnology Sectors-Analysis Year 2003 and the Department of Trade and Industry (DTI). ]]> <![CDATA[Japan to have 1000 biotech companies by 2010]]> https://biospectrumindia.com/news/95/1490/japan-to-have-1000-biotech-companies-by-2010.html https://biospectrumindia.com/news/95/1490/japan-to-have-1000-biotech-companies-by-2010.html Tue, 10 May 2005 12:40:00 +0530 The Japanese government has made very strong commitments to support development of biotechnology industry and small businesses. The Japanese government estimates that its biotechnology market will reach 25 trillion yen and create at least 1000 new bio-based companies, driven primarily by transferring basic research and development into industries that are entrepreneurial in nature. Japan in 1998 had just 10 companies and by 2002 there were 333 bio-companies. In 2004, there were 450 bio-companies. In their Statistical Analysis of Japanese "Bio-ventures" in 2003, Japan Bioindustries Association (JBA) reported identifying over 330 bio-ventures earning a total of 105 billon yen in sales in Japan. Over one-third of these ventures, 154, were bio-medical ventures in the Kanto area. The top four commercial areas were pharmaceuticals and diagnostics (94 companies), DNA and protein analysis (78 companies), bioinformatics (41 companies), and reagents and research tools (38 companies). According to Dr Yasuhiro Hashimoto, president and CEO, MediBic, unlike in the US where small entrepreneurial companies made the first steps into biotech, large established Japanese companies were the pioneers in Japan's early biotech industry. The Japanese government has funded long-term projects. About 46 percent of bio-based companies are spin-offs from the larger companies that are seeking to commercialize academic research. Dr Hashimoto further added, "Japanese pharmaceutical companies look for alliance partners aggressively. Major targets for their partners are US/EU biotech companies. Now they are closely looking at China and India. The alliances with Japanese biotech companies have just begun now." "Japan is not familiar with the Indian biotech industry" -Yasuhiro Hashimoto, president and CEO, MediBic MediBic's president and CEO, Yasuhiro Hashimoto was in Bangalore to attend the annual biotech event Bangalore Bio and shared some views on how India can forge better ties in biotech with Japanese companies, with Priya Padmanabhan of CyberMedia News. MediBic, founded in 2000, went public in 2003 and has a market cap of $100 million. Are Japanese biotech companies aware of the potential that India offers right now? The Japanese industry is not familiar with the work that is going on in India. For partnerships, many Japanese researchers have historically looked towards US and Europe. Biotech is a new area of focus and the Japanese industry is now looking at opportunities in China and Korea, which are geographically close. Historically, Japan has no connections with India. Besides the distance, language is a barrier. Indians speak English but that is a disadvantage if one has to do business in Japan. Countries like Korea, China, Taiwan and Singapore have Japanese speaking people, which make it easy to do business. India should do something to address this problem. While big companies like Toyota find it easy to come to India, for researchers it is difficult since we are smaller companies. People learn about India's technology, excellence and standards largely through Silicon Valley in the US. Can you tell us about your partnership with Strand Genomics, in which you have invested recently? Strand works with pharmaceutical companies to provide total solutions to Japanese pharmaceutical companies. They are looking for technologies to make their research better like in silico drug discovery. We get inputs from pharmaceutical companies and so Strand is able to customize their products to suit Japanese customers. MediBic's association with Strand Genomics has made the latter very famous in Japan. We are demonstrating the results of a successful relationship with India. Initially, the Japanese customers thought Strand Genomics was an American company. ]]> <![CDATA["Western Australia is interested in supporting collaboration with India"]]> https://biospectrumindia.com/news/95/1496/western-australia-is-interested-in-supporting-collaboration-with-india.html https://biospectrumindia.com/news/95/1496/western-australia-is-interested-in-supporting-collaboration-with-india.html Tue, 10 May 2005 12:36:00 +0530 - Keith Anthonisz, manager, Biotechnology, Department of Industry and Resources, Western Australian Government, who was in India to participate in BangaloreBio 2005 and promote AusBiotech 2005, spoke to BioSpectrum about the biotechnology industry in Western Australia and opportunities for Indian companies to work with the Western Australian biotechnology companies. Excerpts of the interview: What are the biotechnology advantages of Western Australia? The key advantages of Western Australia include innovation, skilled and highly educated work force, low cost research, and unique biodiversity. You have have a similar scenario in India too. Western Australia has highly skilled and well-educated workforce. With five world-class universities and technical education institutions producing a broad range of biotechnology graduates, there is a ready supply of essential skills for the industry. It is also home to the most successful Technology Park in Australia and many highly regarded innovative companies. The Western Australia Technology Park â€“ which is celebrating its 20th anniversary, is the one of the largest technology parks in Australia and also in South East Asia. Academia, industry and the government are rich sources of innovation offering great opportunities in commercialization. The overall costs of undertaking research in world-class research infrastructure in Western Australia are low compared to that of Europe and the USA. At the same time, the state is a preferred location for those seeking an envious quality of life. In fact, a recent international study ranked Perth as the third best place in the world to live in. With a land mass of over 2.5 million sq.km (1 million sq.miles) and a coastline of 13,500 km, Western Australia harbours one of the world's largest and most diverse collections of unique biota that span across climatic regions ranging from sub-tropical through temperate to mediterranean, as well as one of Earth's largest reef systems. Which are the focused areas of biotechnology in Western Australia? In Western Australia, there are about 140 companies and organizations, which were listed in the Western Australian Biotechnology Directory, 2003. However, there are about 45 core biotechnology companies in Western Australia employing 542 staff. The Western Australian biotechnology sector is complex due to the variety of applications ranging from commodities to very high value-added products and services. The sector has competitive strengths in science education, research teaching, dedicated research institutions and facilities, as well as a unique culture in research collaboration and a long track record in agricultural research development. The focused biotechnology areas include biomedical, agricultural biotechnology, resource-based biotechnology, bio-leaching and hydrometallurgical processing, environmental biotechnology and bioinformatics. Nanotechnology is also an emerging area with Psivida, a company that produces Biosilicon for the slow release of drugs enjoying a 1247 percent return to share holders in 2004. Biotechnology has emerged from research carried out in the universities and research institutes in the state and represented 10 percent of new biotechnology firms in Australia in 2003-04. What are the incentives offered by the government of Western Australia to biotechnology companies? The Western Australian government has a program to support biotechnology in the state. The state government has been a major investor in infrastructure development and basic research in agriculture. Biotechnology companies do get tax benefits and other incentives. Under the Biotechnology Innovation Fund and Commercial Ready Fund, the companies also get funds. Besides,companies have VC funding and IPO funding. How you see India as a biotechnology market? India is emerging as a major economy in the developing world. And it is the third largest economy in the third world countries. In many areas â€“ geographical, climatic zones, biotechnology advantages, India has similarities with Western Australia. With the introduction of IPR by India from January 1, 2005, it has strengthened its base among the investors. The government of Western Australia has been funding projects in India. And it is now interested in supporting collaborative projects in biotechnology with India and is looking at supporting companies and research institutes to form partnerships that are mutually beneficial. Western Australian companies like TRI-MED, Proteomics International and Inner Vision Biometrics are showing interest for a partnership with Indian pathology laboratories, hospitals or medical distributors for their products, and looking for expanding and formalizing their links to Indian research.  Narayan Kulkarni ]]> <![CDATA["Stem cells could be the greatest medical advance in history"]]> https://biospectrumindia.com/news/95/1822/stem-cells-could-be-the-greatest-medical-advance-in-history.html https://biospectrumindia.com/news/95/1822/stem-cells-could-be-the-greatest-medical-advance-in-history.html Tue, 10 May 2005 12:34:00 +0530 - Rachel Eiges, The Alexander Silberman Institute of Life Sciences, Israel Comment on the potential application of stem cells. I think they have great potential. Although I think we have a long way to go before we consider them for the use of clinical applications. I think we really have to develop much more efficient methods for their differentiation and working on testing their functions. The goal of stem cell therapy is to repair damaged tissue that cannot heal itself. Stem cells could be the greatest medical advance in history in the sense that most of our serious diseases can be cured. Can you elaborate on your institution's research work? The institute is affiliated to the Hebrew University of Jerusalem. It has several departments like biological chemistry, genetics, cell and animal biology, plant sciences, evolution systematics and ecology (ESE), neurobiology, microbial and molecular ecology and national and international research centres. I belong to the genetics department. The genetics department again has sections such as human genetics, animal genetics. Research at our institute includes areas such as genetic regulation and cellular differentiation in eukaryotes and interactions between chromosomes and the nuclear envelope, developmental, genetic and molecular analysis of complex characteristics in drosophila, in chicken and in mouse. We have now settled down with certain methodologies. We have learnt how to morph the stem cells, how to manipulate them genetically and sort them and start working on them. They are a bit difficult to grow and difficult to do experiments with. We have been having problems in analyzing their functions and purifying them to specific cell types. So we are going slow. Actually we have been thinking of shifting from cell biology applications to basic research. What do you think are the hurdles in the field of stem cell research? Lately researchers have been thinking very applicably where funding is. There is a lot of money going into stem cells as there is a great demand for cell transplantation medicine. Stem cells have other applications too but since there is not much money involved here, people don't really appreciate the others uses of stem cells. Namratha Jagtap ]]> <![CDATA["We have a very broad genetics program within the UK"]]> https://biospectrumindia.com/news/95/2662/we-have-a-very-broad-genetics-program-within-the-uk.html https://biospectrumindia.com/news/95/2662/we-have-a-very-broad-genetics-program-within-the-uk.html Tue, 10 May 2005 12:32:00 +0530 - Dr Paul Scotting, senior lecturer in Genetics, Institute of Genetics, University of Nottingham. Can you elaborate on research being done at your institute? The Institute of Genetics is one of Nottingham University's acknowledged strengths in research. We excel in areas of biological research, from genes to genomes, from molecules to cells, from model organisms to humans. We have a very broad genetics program within the UK. One of the unusual features of our genetics department is that we maintain a range of genetics. So as such we have disciplines like developmental genetics which is my field, human genetics, and then we have a strong history in population evolution, fungal biology and genetics and we also have molecular microbiology and genome dynamics. Basically our research interests lie in molecular neurogenesis and neuro-oncology and the techniques involved which includes in situ hybridization, in vivo electroporation, chick embryo and zebra fish manipulation. Our group focuses on the eukaryotic gene expression and the genetics of vertebrate embryonic development. Our work on the control of gene expression address the machinery used by cells to achieve appropriate levels of functional transcripts. These studies include control of transcription and the mechanisms of RNA maturation. My interests lie in the molecular basis of nervous system development in vertebrates, especially the role of transcription factors in neurogenesis and paediatric brain tumours. What do you feel about the potential applications of stem cells? In terms of newer therapeutic approaches, I feel the idea of using bone marrow cells for transplant is a very strong avenue. Also researchers need to explore both adult and embryonic stem cells as different diseases may benefit from treatment with different cell types. The adult stem cells have unique advantages. If they can be recruited to specific tissues, then this approach could be used to enlist the body to fight its own disease. Namratha Jagtap ]]> <![CDATA[Stem Cell Initiatives Proliferate]]> https://biospectrumindia.com/news/95/2589/stem-cell-initiatives-proliferate.html https://biospectrumindia.com/news/95/2589/stem-cell-initiatives-proliferate.html Tue, 10 May 2005 12:26:00 +0530 With collaborations being the mantra for success, a joint UK-India workshop was held in April to foster stem cell research. The UK has a pragmatic, but not permissive, policy on embryonic stem cell research. India too has a similar approach on stem cell work and a lot of advanced research is happening in this sphere. India and the UK are keen on leveraging their respective strengths and explore collaborative therapeutic work in the field. As a major step in this direction, a week long "Indo-UK stem cell workshop" was organized in April in Bangalore. British high commissioner to India, Sir Michael Arthur noted, "We recognize India's growing strengths in this field of research. We hope that the stem cell workshop will be a catalyst for a number of Indo-UK collaborations in this area of research that holds much promise for benefiting human health." Sir Arthur pointed out that the global revenues in the stem cell and tissue engineering market are estimated to touch $10 billion by 2013 and that the UK plans to achieve sizeable share through collaborations and joint ventures. "Stem cell research in the UK is funded primarily by the medical research council and its strength lies in therapeutic cloning, diabetes and neuron diseases and it is here that the UK is looking at taking up collaborative research to carry forward its application," added Sir Arthur. The UK in its 2005 budget has announced £2.5 billion allocation for biotech. "A certain amount of this is kept aside for stem cell research. Our Biotechnology and Biological Sciences Research Council has invested about £17 million in stem cell research over the last 10 years and our Medical Research Council spends about £4.5 million annually. Since 1995, the Wellcome Trust has awarded 15 project and program grants specifically for stem cell research, totaling about £4.5 million." Prof Azim Surani of University of Cambridge, lead the UK delegation, which was represented at the workshop by National Stem Cell Bank, the UK Stem Cell Initiative, the UK Stem Cell Foundation (led by private sector), the Human Embryology and Fertilization Authority and a number of other stem cell centers. In another development, Dr Anbumani Ramadoss, the union minister for health and family welfare, said, "The government would also boost stem cell research in India and informed that the country would host an international conference on stem cell research in September 2005 in Mumbai." ]]> <![CDATA[Bangalore Bio 2005]]> https://biospectrumindia.com/news/95/1988/bangalore-bio-2005.html https://biospectrumindia.com/news/95/1988/bangalore-bio-2005.html Tue, 10 May 2005 11:31:00 +0530 Bangalore Bio 2005, the three-day tradeshow and conference held in April in Bangalore, props up Karnataka's BT initiatives. Biotechnology in India is still at a nascent stage. And it's time now to amplify the growth of biotech nology. The fifth edition of Bangalore Bio 2005 held in Bangalore during April 22-24, 2005 deliberated on how the country should gear up to achieve its revenue target of $5 billion by the year 2010. Kiran Mazumdar-Shaw, chairperson of Karnataka's Vision Group on Biotechnology and CMD, Biocon Ltd, speaking at the inaugural ceremony of the event, cited biotechnology development in Karnataka as an example of successful partnering. "While Biocon has tied up with Vaccinex for development of monoclonal antibodies and Nobex of USA for development of oral insulin; Strand Genomics has joined hands with MediBic of Japan and Avesthagen has tied up with Biomerieux of France for diagnostics." Shaw also mentioned other biopartnerships forged by a few more Bangalore-based companies including Syngene, Reametrix, NCBS, AstraZeneca and Bangalore Genei. "The success of positioning India as a strong partner for global companies will depend on the ability of the Indian biotechnology to apply its people resource in a knowledge intensive manner. International bio-partnering has already gained visibility in India and especially in Bangalore where several collaborative partnerships have been initiated," she noted. Karnataka Chief Minister N Dharam Singh, who presided over the function, said that the state government gave utmost priority to attracting investments into Karnataka and the high-level committee which approves major industrial projects, had cleared projects worth over Rs 40,000 crore in the last 10 months. The Department of Biotechnology (DBT) had sanctioned Rs 14.45 crore for Bangalore Helix biotech park and work on the project would begin by June, Dharam Singh informed. A sum of Rs 11.5 crore had already been released to the Institute of Bioinformatics and Applied Biotechnology (IBAB) to set up its campus in the biotech park, the chief minister added. "Karnataka has accounted for the highest number of new biotech companies established over the last 12 months and the biotech sector in the state has attracted maximum VC funding of $100 million." Out of the 265 companies in India, Karnataka is home to 131 companies of which 127 are based in Bangalore, Singh noted adding that Bangalore is the fastest growing biocluster in India. The companies employed a total manpower of 12000 and a total scientific manpower of 7500 in 2005. In his remarks, Dr Anbumani Ramadoss, the union minister for health and family welfare, pointed out that the global biotech sector is valued at $40 billion with a market capitalization of $375 billion. Nearly 250 drugs have emanated from biotechnology over the last decade, which now constitute a significant 20 percent of the pharmaceuticals pie. By the year 2025, the ratio will be skewed in favour of biotech drugs which are expected to assume a share of 75 percent, Dr Ramadoss pointed out. The union minister informed that the medicinal plant industry in India was picking up and many countries had shown active interests in adopting the Ayurveda and Siddha systems of medicine in their healtcare sector. He said the government would invest more in biotechnology, which had a holistic approach to prevention, diagnosis and treatment of diseases. The Hepatitis B programme would be incorporated into the immunization schedule, he said. The government would also boost stem cell research in India, he said and informed that the country would host an international conference on stem cell research in September 2005 in Mumbai. He further told the gathering that the government would regulate clinical trials keeping in mind ethical issues but it would ensure that there are no hurdles for scientists conducting quality research. Dr Ramadoss said a bill towards this would be shortly introduced in the Parliament. In his address Dr M K Bhan, DBT secretary, said that the Central government would accord priority to global partnerships and provide a hassle-free environment to global partners. Biotechnology is a frontier area of science and technology having a great potential for welfare of humanity, said Rajasthan Chief Minister Vasundhara Raje in her address. "We need to focus on research, development and IPR generation in the area of vaccines, diagnostics, new medicines derived from utilization of traditional knowledge, value added products through application of food biotechnology, increased productivity through pest and disease resistant genetically modified crops and eco-friendly technologies." In his address, Sir Michael Arthur, British High Commissioner to India, said the UK government was very keen on economic partnerships with India. UK-based Randox Laboratories would set up a diagnostics kit manufacturing unit in Bangalore. Shantha Biotechnics had signed an agreement with Polytherix, a spin-out biotech firm of the University of London, to make an affordable PEG-interferon product for treatment of Hepatitis C. Zenosis Ltd, which has built and developed protein bio chips had entered into a pact with Edutech of India to share expertise in knowledge support services. The fifth edition of Bangalore Bio 2005 saw the participation of 15 countries, nine states and 125 companies. While Jairam Ramesh, national economic advisor and member of Parliament, stressed on the globalization of Indian biotech, Nobel Laureate Prof Sydney Brenner, chairman, Biomedical Research Council, Singapore, spoke on economics. He said " Biotech is not a new science. But the central dogma of biotech that DNA makes RNA and RNA makes proteins is changed today. It must be added that proteins make money." Ch. Srinivas Rao and Namratha Jagtap ]]> <![CDATA[Vaccine players need to collectively develop the market]]> https://biospectrumindia.com/news/95/2077/vaccine-players-need-to-collectively-develop-the-market.html https://biospectrumindia.com/news/95/2077/vaccine-players-need-to-collectively-develop-the-market.html Mon, 11 Apr 2005 16:50:00 +0530 The Indian pharma industry is making significant in-roads into the global biopharmaceutical segment. The human vaccines market represents the fastest growing segment within this sector. India is fast emerging as a major hub for both manufacturing and export of vaccines. The major demand drivers for vaccines are the government's National Immunization Programmes (NIP) and increasing demand from Global Consortiums such as GAVI, WHO and UNICEF. The growth that has been witnessed is primarily due to the presence of low cost and high quality domestic manufacturers of vaccines like Bharat Biotech, Shanta Biotech and Serum Institute of India. "In the Indian context, the most important issue is to make healthcare system affordable. Another challenge is the effective distribution of the vaccine,"- Rajesh Jain, joint managing director, Panacea Biotec India produces traditional as well as new vaccines such as Hepatitis A and B vaccines. According to the Indian Medical Association (IMA), as many as 22 companies both local and multinationals are selling about 25 vaccines in the Indian market for different diseases. The largest markets for vaccines in India in ascending order are for Tetanus Toxoid, Polio, DPT, Typhoid and Hepatitis B. The leading vaccine producers of the world too have their presence in India. Of the five major global vaccines producers, Chiron has already set up its base in Gujarat, while GlaxoSmithKline's vaccine filling facility will become operational early next year at Nasik. Aventis Pasteur has its presence not as a manufacturer but as a supplier. It has as many as 13 products in India. Merck too is considering setting shop in India. Current scenario "A positive trend is being seen both at the global and the domestic level. The industry is currently growing at the rate of 20-30 percent. The volume of the business is growing with the newer vaccines coming in and companies are increasing their production capacities. In the area of vaccine exports, India and China are poised to be the future global hubs," said Rajesh Jain, joint managing director, Panacea Biotec. The spurt in vaccine market was mainly due to the entry of new players and new vaccines. But in 2000-2001, the growth was slowed to 18-20 percent, as the newly introduced brands lowered the prices by 35-40 percent. In 2003-04, the market grew at 18.64 percent and accounted for 47 percent of the total biopharma segment, with sales of Rs 1138.50 crore. The total domestic vaccine market is estimated at Rs 600 crore in 2004. Serum Institute of India, the largest player of vaccines in India, alone accounted for 32 percent of the global vaccine sales in 2000. Over the years, global organizations such as GAVI and WHO have been increasing the vaccines procurement from emerging suppliers in India. These organizations procure vaccines from vaccine manufacturers at very low prices assuring them a long-term contract. At present Panacea Biotec, Serum Institute of India and Shantha Biotechnics and Chiron Behring from India have got recognition as WHO pre-qualified vaccine manufacturers. Now Biological E is in the process of attaining WHO pre-qualification. Indian players are able to manufacture large volumes of dosage at a competitive price in a considerably low downtime. Wockhardt and Bharat Biotech have developed vaccines at almost one-fourth of the prevailing prices of vaccines manufactured in the West. Leading companies like Shantha Biotech have been very successful in reducing the cost of some of the vaccines by more than 70-80 percent. Growing demand, shrinking base of vaccine manufacturers in the developed countries, cost pressures, etc. have given India and other developing nations the opportunity to fill the widening gap. Challenges before the industry Making vaccines is a serious business and one cannot start it in a short span of time. The gestation period is long and the business requires very evolved technology. Besides, the intellectual property has to be very strong. "Today India is in the infancy of immunization. The vaccine market has to evolve in the country and a lot of effort is required to bring in a level of maturity. First of all we require huge investments for mass education and awareness in the country, as there are more than 5,000 districts and 7 lakh villages. There has to be a lot of stress on parent education and dissemination of information through mass media like TV and radio. A focused emphasis on rural education is required. Secondly, a great deal of work needs to be done on generating clinical data on vaccines, collecting epidemiological data, total disease incidence, disease prevalence, etc. Then the outreach of vaccines has to broaden. In the Indian context, the most important issue is to make healthcare system affordable. Another challenge is the effective distribution of the vaccine - how far are we able to maintain the cold chain and how deep is our reach," said Rajesh Jain, joint managing director, Panacea Biotec. Expressing similar views S Kalyanasundaram, managing director, GlaxoSmithKline Pharmaceuticals Ltd said, "In a business like vaccines we have to invest substantially to develop the market. In India everybody has entered the market and killed the Hepatitis B market. The prices were crashed. The volumes remained at same levels. Even the peak volumes are not achieved in this space. So we only hope that all the players in addition to manufacturing and delivering the vaccines to patients, should also take into account the need to continue to invest in the market development, invest in establishing communication between doctors and patients and also creating awareness about the use of vaccines. " Ch. Srinivas Rao with Narayan Kulkarni and Rolly Dureha   ]]> <![CDATA["We have long-term commitment to India through vaccines" - S Kalyanasundaram, managing director, GlaxoSmithKline Pharmaceuticals Limited.]]> https://biospectrumindia.com/news/95/5314/we-have-long-term-commitment-to-india-through-vaccines-s-kalyanasundaram-managing-director-glaxosmithkline-pharmaceuticals-limited-.html https://biospectrumindia.com/news/95/5314/we-have-long-term-commitment-to-india-through-vaccines-s-kalyanasundaram-managing-director-glaxosmithkline-pharmaceuticals-limited-.html Mon, 11 Apr 2005 16:48:00 +0530 GSK has a vaccine filling facility coming up at Nasik. What made GSK look at Nasik when companies are looking at setting up units in Haryana, J&K and Himachal Pradesh for tax benefits? In Nasik, we have a major pharmaceutical facility with 800 strong people. They have the experience and expertise in different areas including those like the vaccines. Vaccines are technology intensive products and our efforts will be to produce high quality vaccines. What is the capacity of your upcoming facility at Nasik? Our factory is capable of delivering vaccines to all children in the country. That is the capability we are creating at Nasik. GSK is able to manufacture and sell vaccines to the tune of 1.5 billion doses. If you look at the global population with newborn babies of 120 million, even if you assume 80 percent of our 1.5 billion doses goes to children, then every child will probably be consuming 8-10 doses of GSK vaccines. We are not only selling for children but also for adults. Your focus is on self-pay market and not on government organizations. With this new plant coming up, will you be looking at the government agencies? We have a number of vaccines. For example, Hepatitis B vaccines have now been introduced under the immunization program in India. Similarly, in other developing countries including China, it has been included in the immunization program. Our next vaccine is Rotarix to prevent rotavirus gastroenteritis in children. Hundreds and thousands of the children die due to this virus in India. We have a number of other vaccines including Hiberix (a Haemophilus influenzae type b vaccine) - a vaccination for infants from the age of six weeks onwards against Hib. The newborns will benefit through the immunization program. The facility will open up a window of opportunities for us as it has the capabilities to manufacture these vaccines. Globally our spirit is public-private partnership. In India also our commitment is the same as our global spirit. There is no change in it. We are actually working with the government on a number of programs, which will fulfill our current government's vision too. We have a lot of opportunities in India and we can play a good role in fulfilling the government's vision. What is GSK's investment for this new vaccine facility? In Nasik, we are sharing a lot of the core facilities with the existing pharmaceutical facility. If we want to set up a stand-alone facility, which can meet the global standards, it requires at least about $20 million. At the foundation stone laying ceremony, you noted that the new facility reflects GSK's commitment to India. Does it mean that whatever the plant produces, will be used to meet only the needs in India or are you looking at exports as well? Again my reply is the same. We have long-term commitment to India through vaccines. By putting up the facility, we are saying that we do cater to the needs of India. Having said that if you look at the entire population of the South East Asia, it will be half a billion. So covering exports is no more an added benefit. The fundamental focus and justification is the Indian market. We will also keep the exports option in mind and as and when it comes, we will look into it. Indian pharmaceutical companies are looking at exports as money-spinners. Considering this, will GSK look at export of vaccines as core opportunity? There is a difference between the Indian companies and GSK. If you look at Indian companies most of them are transnational companies - originated in India and headquartered in India. We are a subsidiary and an arm of a global company with focus on India. So the business model will vary with different organizations. Again India will be our focus. But exports will be added benefits. Who do you see as your competition-MNCs or the Indian companies? I respect all our competitors. Each one will have distinguished advantages. If you look at companies in the same range of product portfolio, they all follow the same marketing strategy. They will have the same work culture. Hence they are our competitors. If you look at the Indian companies, they may not have a comprehensive product portfolio of vaccines. But you know what they did in the case of Hepatitis B. The entry has brought the prices of vaccines down. So both of them offer different types of opportunities and challenges. That is why I am saying MNCs-Aventis already has a wide range products, Chiron has its presence in India with a manufacturing facility, and Merck may come in the future-are our competitors. In India you have Serum Institute of India and Panacea Biotec. For different reasons Indian companies, unlike MNCs who have very large portfolio, have their own strategies. They manage it quite well. It can damage some of our opportunities. I think they are competitors. We take on every company with due respect. What is this "Famili Vaccines" concept that GSK introduced last year in India? We are very happy that this world-class concept was implemented in India a couple of years ago by GSK. It is a long-term market development program, which brings interaction between mother and doctor. It is a highly innovative concept. We have a range of vaccines for the entire family. Normally in a family, the mother takes care of the health of the entire family. So she will get the relevant information about the range of vaccines a family needs under this public-private program. What is the revenue you are looking at from your vaccines business? The revenue of GSK vaccines in India is over Rs 100 crore. It is growing more than the growth of the pharmaceutical section. In the last three years, it has been growing at a rate of 20 percent. And it is expected to grow more than this as we have about a half dozen products in line for introduction in the coming few years. Narayan Kulkarni ]]> <![CDATA[India high on GSK's radar]]> https://biospectrumindia.com/news/95/7989/india-high-on-gsks-radar.html https://biospectrumindia.com/news/95/7989/india-high-on-gsks-radar.html Mon, 11 Apr 2005 16:46:00 +0530 On February 22 this year, Glaxo SmithKline or GSK, commenced the work to set up a vaccine filling and packing unit for vaccines intended for India. And it is expected to be fully operational by early 2006. "This day marks a historic milestone for GSK in India. This new vaccine facility reflects the company's commitment to India and recognises the high quality skills and science base in India. As India continues to improve the framework, especially protection of intellectual property rights, its attractiveness to investors such as GSK will grow," noted S Kalyanasundaram, managing director, GSK India and vice president, South Asia, GSK International at the groundbreaking ceremony at Nasik. This development is a significant one considering the fact that GSK had given the green signal for a vaccine filling and packing unit for vaccines intended for India as early as 2003. And the building work next to the GSK Pharma production unit at Maharashtra Industrial Development Corporation (MIDC), Ambad, Nasik was supposed to commence in 2004. And it finally took off in February 2005. It may be recalled that GSK manufactures all of its vaccines at Rixensart, Belgium, and Germany. In 2003, it delivered over 780 million doses of vaccines across 156 countries including India, the US and Western Europe-an average of 25 doses per second. The vaccines for India are also currently developed, produced, filled and packaged at the company's vaccines headquarters and manufacturing facility at Rixensart, Belgium. The Nasik facility will be GSK's first manufacturing site to co-house a pharmaceutical and a vaccine-manufacturing unit. The quality control will be under close supervision of GSK Biologicals, Belgium. The manufacturing facility, when completed, will possess all attributes of the most modern vaccine-manufacturing plants globally. The plant is being built to cater to the Indian market needs, which could be expanded to meet the requirements of neighbouring countries. GSK Vaccines, a part of the GlaxoSmithKline Pharmaceuticals Ltd, supplies vaccines to protect against a wide range of infectious diseases including diphtheria, Hepatitis A and B, Hib infections, influenza, measles, meningitis ACWY, pertussis, polio, rubella, tetanus and chicken pox. It has been amongst the first few to have introduced these products in the country. It recently launched "Mencevax ACWY", the first and only meningitis vaccine available in India. "Meningococcal meningitis has grown to be a serious cause for concern, predominantly affecting travelers and people living in crowded spaces. Vaccination is the most effective, practical and convenient way of preventing this disease. GSK has been supplying the vaccine to the Indian government for the last three years and has now made it available to the private market as well," noted Sumer Dheri, general manager, GSK Vaccines. Besides having many firsts to its credit, it is a key player in cold chain management, which helps to keep the vaccine's potency intact and is the most reliable in its category and trusted by private practitioners. The company has been a pioneer in creating consumer awareness about vaccine preventable diseases through direct in-clinic education materials and also through its innovative and novel concept called Famili Vaccines, an immunization awareness initiative of GSK group in India. In India, GSK Vaccines has a field force of 150 people and 11 vaccines for both adult and pediatric categories. The sales from this division stood at Rs 80 crore for the year ending December 2003 and is growing at rate of 20 percent each year. It has so far covered one fourth of the Indian vaccine market. And it is now focusing on taking away the un-represented or grey market, which is close to 40 percent. In addition to selling and marketing vaccines, India is supporting GSK Biologicals in its vaccines development process through its clinical data management center based in Bangalore, for the last 10 years. GSK Biologicals now is considering developing India as a global hub for clinical research and development. GSK has lined up global trials for four vaccines-two vaccines for rotavirus, one for cervical cancer, and a combination DTP vaccine in India during 2005. It is also going to conduct clinical R&D for its AIDS, dengue, malaria and TB. It hopes to conduct trials in India for all its products in the research pipeline. GSK's vaccines pipeline is amongst the best in the world, particularly those against diseases such as rotavirus, malaria, TB, dengue fever, Hepatitis E and typhoid. It is expected to introduce newer vaccines in India in the next few years. Prevention is after all better than cure and nobody knows that better than the vaccine manufacturers. This belief helped GSK Vaccines to achieve the market leadership in India and it continues to play a major role in serving the people better. ]]> <![CDATA[Customs duty reduction boosts biotechnology sector]]> https://biospectrumindia.com/news/95/2649/customs-duty-reduction-boosts-biotechnology-sector.html https://biospectrumindia.com/news/95/2649/customs-duty-reduction-boosts-biotechnology-sector.html Mon, 11 Apr 2005 16:41:00 +0530 The Association of Biotechnology-Led Enterprises (ABLE) had initially recommended a set of 20 different equipments for exemption from custom import duty to the Finance Minister, of which nine were finally selected. The criteria for selecting these equipments was the fact that they are commonly required to set up a relatively advanced biotech R&D lab and since most of them are not manufactured in India, they have to be imported. This move is aimed at reducing the capital cost of R&D and help the biotech companies to realize the full potential of its scientific skill base at a commercial level. Equipment that benefit Cell cultivation devices - roller bottle systems and spinner flasks CO2 incubator DNA/Oligonucleotides Synthesizers Electrophoresis system (Protein, DNA, 2D) ELISA Reader and washer Fluorimeters Low Temperature Freezers (minus 70 degrees and less) Spectrophotometers (including Nuclear Magnetic Resonance Spectrometers) This decision has also brought cheer to the bio-suppliers sector, as today India is predominantly an importer's market, with domestic sales accounting for more than 97 percent share of the total industry size. Most of the leading global suppliers have their presence in India either directly or indirectly and continue to dominate the market in line with their global dominance. Most of the leading suppliers dealing in these equipments are still grappling with the financial implications of the reduction in custom duty and believe that a clear picture will emerge only in April once the revised duties are in place. But overall, the move has been cheered by one and all. Navneet Trehan, corporate vice president and director, Axygen Scientific, said, "We welcome this decision and if it leads to a reduction in the prices of the equipments, then we will definitely like to pass the benefit to our customers". Dr Arvinder M Singh, general manager, life sciences, PerkinElmer India echoed similar views. "We do not import equipments and supply them. The ordered equipments are directly shipped to our customers from our warehouses across the world. So if there is any duty reduction, then our customers will be directly benefited," he said. PerkinElmer, was earlier operating through LabIndia, but has recently established its direct presence in the country. Some industry leaders opined that the list should be broadened and more instruments should be brought under its purview. VS Upadhye, director, LabIndia Instruments, commented, "The list is good but not exhaustive. It should also include PCR systems, DNA sequencers as these are widely used in R&D in almost every lab today. In fact these items should be given the top priority. Another equipment which should be considered is the mass spectrometer as it is a commonly used expensive equipment." Similarly, Arun Prakash, CEO of Delhi-based Genetix Biotech Asia, said, "This move is really welcome but cell factories should also be included into the list as this cell cultivation device is a major requirement of the biotech industry. Moreover, as India is fast becoming the global hub of vaccines, with many Indian companies producing and exporting them, if duties on such devices is reduced, then it will not only boost the sales of the domestic companies but will go a long way in promoting the growth of the Indian biotechnology industry." Now that the biotechnology and pharmaceuticals have been recognized as the sunrise sectors by the top key policy makers of the country, more may be in the offering in the future. As observed by Nitin Deshmukh, director, ABLE, "Biotechnology is still in nascent stage in the country and is largely a reach-oriented industry. Things are going in right direction. One cannot expect all in one shot. Things will rollout. And one has to be pragmatic." "This gesture will certainly help Biotech R&D in a big way" Bipin Deshmane, general managerâ€“fermentation, Shreya Biotech, provides an in depth view about the equipments on which custom duty has been reduced and those which have been left out. Equipment for which customs duty has been reduced â€¢ Reduction in duty on cell cultivation devices such as roller bottles and spinner flasks will facilitate the research on cell culture. Many of latest biotherapeutics are of cell culture origin eg. Erythropoetin, tPA, variety of monoclonal antibodies. Animal cell culture is much more difficult, cumbersome, time consuming contamination prone as compared to bacterial or fungal cell culture. The gestation period for such projects is very high. This step by the FM will be welcome by industrial cell biologists. â€¢ ELISA technique is very common in assaying activity of most of the biotherapeutic proteins. ELISA reader and washer are part of any rDNA based Biotech lab. Now these equipments will be cheaper for industry to instal in their labs. â€¢ Electrophoresis system â€“ both for DNA and protein â€“ is a routine analytical procedure for qualitative (and sometimes quantitative) estimation. Electrophoresis is used day in and day out for In Process as well as final product analysis of rDNA based biotherapeutic proteins. Prices of these equipments will come down. â€¢ Minus 70 degrees Celsius freezers is a must for storage of bacterial and fungal cell cultures. This satisfies the basic requirement of any biotech lab. Spectrophotometer is another basic and a must type of equipment. â€¢ DNA synthesizers are a costly affair for industry. Reduction in duty will certainly encourage the industry to venture in to it. Equipment for which customs duty reduction has not been considered â€¢ Fermentors with ancillary instrumentation are required to grow any industrially important bacterial and fungal cell cultures (whether it is normal or genetically engineered) in order to produce biotech products. No biotech lab can be started without fermentor. â€¢ The Finance Minister should have reduced customs duty on microscope, which is required to observe any organism. Industry cannot afford electron microscope but for routine optical microscopes reduction in customs duty was very much required. â€¢ Membrane filtration (micro, ultra, nano, RO) technology is largely being used in purification of biotech products including proteins. Duty reduction would have helped in using this technology as a part of purification. â€¢ Most of the latest biotherapeutics are proteionic in nature. Chromatography is the heart of any purification scheme. No reduction in customs duty in this segment is really disappointing and disheartening for biotechnologists. â€¢ PCR is another equipment, which is commonly used in genetic engineering lab. Very simple but innovative technique is very handy and useful. â€¢ Most of the latest biotherapeutic proteins are injectible and hence water quality used for their production (upstream and downstream) is very important and crucial. Hence water purification system at lab and pilot study level rightly deserves duty reduction. â€¢ In the field of Genomics and Proteomics, Microarray equipment with necessary paraphrenia is very much required. This is latest and most advanced technique (and of course costly also), which deserves duty exemption. â€¢ Nevertheless, the Finance Minister has shown a gesture of reducing custom duty on quite a good number of equipments, which should be welcome wholeheartedly. This gesture will certainly help a long way for biotech R&D. We hope that next year's budget will take care of rest of the equipments. ]]> <![CDATA[Affymetrix GeneChip Platform]]> https://biospectrumindia.com/news/95/2846/affymetrix-genechip-platform.html https://biospectrumindia.com/news/95/2846/affymetrix-genechip-platform.html Mon, 11 Apr 2005 16:40:00 +0530 The Affymetrix GeneChip system analyses all oligonucleotide based probe arrays for expression analysis, genotyping and health management. The platform mainly comprises of the gene chips, kits, hybridization oven, fluidics station, high-resolution scanner and computer/software workstation for control, data acquisition and analysis. Affymetrix has GeneChips for human, eukaryotes, prokaryotes and plants. The system helps in generating reproducible genetic analysis data. Custom designed arrays can also be produced based on the sequence data. The new generation Affymetrix GeneChips have 11m feature size and very soon will have GeneChips with 5m feature size. The entire human Genome with ~ 38,500 Genes are available on single GeneChip. Similarly, 100K- array (>100,000 SNP's) is available for SNP analysis, re-sequencing, association studies, linkage studies and chromosome copy number. There are more than 1100 Affymetrix GeneChip platforms in various institutions, universities, pharmaceutical industries and medical research/hospitals worldwide. For more details, contact: spincomd@md4.vsnl.net.in mRNA Quantitation Kits by R&D Systems US based R&D Systems has introduced mRNA Quantitation Kits in the market to assist the biotech industry. Quantikine mRNA kits are simple, colorimetric, microplate-based assays for the quantitation of cytokine-specific mRNA. This kit is capable of quantitating gene-specific mRNA in the attomolar (10-18) range. Using an ELISA-based format, levels of mRNA can be estimated from cell lysate, total RNA, or poly (A)+ RNA samples in less than five hours. This non-PCR based assay offers several advantages over conventional methods of mRNA quantitation, such as Northern blot analysis and semiquantitative RT-PCR. Radioactive isotopes, specialized instrumentation, and extensive assay optimization are not required. The quantitative mRNA assay is capable of both high sample throughput as well as quantitative analysis of multiple target mRNAs in parallel. Quantikine mRNA kits are available in two modules, a Base Kit and a Probes and Calibrator kit. The Base kit is common for all cytokines while Probes and Calibrator kits are assigned for a given cytokine specific mRNA. The Base Kit and Probes and Calibrator Kits can also be purchased individually for multi-analyte analysis. This product is being distributed exclusively in India by Delhi-based Biotech India. For further details, contact: info@biotechindia.com Millipore introduces High Throughput Syringe Filters Millipore has announced the availability of 33 mm Sample Preparation Millex syringe filters with Millipore Express PLUS polyethersulfone (PES) membrane. The syringe filters are used for general particulate filtration prior to high performance liquid chromatography (HPLC) or other instrument analysis. The syringe filters allow the removal of fine particles to protect chromatography columns from premature plugging. The filter's Millipore Express PLUS membrane provides rapid flow rates and high throughput for the sterilization and clarification of 10 to 200 mL of aqueous and mild organic solutions. The low-protein binding membrane delivers twice the throughput of other membrane types. Blotting membrane Millipore has also announced the availability of its Immobilon-FL membrane, the first western blotting membrane specifically optimized for fluorescence applications. The background fluorescence of this polyvinylidene fluoride (PVDF) microporous membrane is nearly 10 times lower than typical PVDF membranes and 2 to 5 times lower than nitrocellulose membranes. As a result, the new membrane offers greater sensitivity and improved protein detection with fluorescent reagents. Acerta DS1 dispensing system Millipore's Acerta DS1 dispensing system, a single-head liquid filling unit, utilizes a pre-assembled, sterile disposable filling module. The system is designed for final sterile injectables and diagnostics in biotechnology and classical pharmaceutical manufacturing across a range of fill weights and applications. This includes process development, new drug development testing, clinical trial filling and small scale production. To provide complete product containment for enhanced sterility assurance and operator safety, all contact parts in the filling assembly are pre-assembled and disposable. This makes the Acerta DS1 system ideal for cytotoxic and gene therapy products. For more information, visit www.millipore.com ]]> <![CDATA[Bio-Therapeutics conference ends on positive note]]> https://biospectrumindia.com/news/95/1439/bio-therapeutics-conference-ends-on-positive-note.html https://biospectrumindia.com/news/95/1439/bio-therapeutics-conference-ends-on-positive-note.html Mon, 11 Apr 2005 16:38:00 +0530 The country's first two-day annual conference and exhibition on "Biotherapeutics: From process development to manufacturing" held in Hyderabad proved to be an interactive platform to share the latest developments in biotechnology and discussed factors affecting process development, manufacturing and research in biotherauptics. The event organized by the India BioGroup witnessed a large gathering of industry players, academicians and foreign delegates. Dr Stephen F Gorfien, director, Invitrogen Corporation, GIBCO Cell Culture Systems, in his presentation on "Introduction and Optimization of cell culture systems", said, "Optimizing productivity can be facilitated by use of complete, integrated systems employing cells that have been pre-adapted to the appropriate regulatory-friendly basal medium, modular kit components and disposable bio-processing systems." Arun Singhal, business area manager, Invitrogen-GIBCO, deliberating on the topic "Raw materials for optimizing, maximizing and being regulatory friendly", was of the opinion that proper selection of media and supplements not just increase the yield but also comply with regulatory requirements. He further emphasized that selection of raw materials is important for both technical and economical reasons besides elaborating on various formats and batch size of cell culture materials. Highlighting the factors that need to be considered while preparing a facility for contract manufacturing of recombinant proteins, Raj Sachdev, manager, technical operations, Baxter BioScience, said, "Companies with no or low available capacity find such contract manufacturing organizations necessary. Such organizations need to focus on issues related to the production of multi-products in the same facility. Also they need to concentrate on several critical issues like preparing an existing facility for manufacturing a new product, issues related to facility or equipment modifications, regulatory requirements, etc." While having manufacturing facility and undertaking production is one issue, compliance with GMP regulations is equally important. The conference witnessed participation from foreign delegates including Saudi Arabia and the US. Sunitha Natti, CyberMedia News ]]> <![CDATA["We can't rule out the possibility of entering India entirely," - Ruth Ryan Lessard, director, regulatory and quality assurance, Avigen Inc.]]> https://biospectrumindia.com/news/95/2474/we-cant-rule-out-the-possibility-of-entering-india-entirely-ruth-ryan-lessard-director-regulatory-and-quality-assurance-avigen-inc-.html https://biospectrumindia.com/news/95/2474/we-cant-rule-out-the-possibility-of-entering-india-entirely-ruth-ryan-lessard-director-regulatory-and-quality-assurance-avigen-inc-.html Mon, 11 Apr 2005 16:37:00 +0530 What is the unique selling proposition of Avigen? Product development is a crucial phase for any company and we ensure that we follow effective practices and still be able to come out within the shortest possible timeframe. Saving time and costs and still produce in compliance with stability standards is what differentiates us. Do you have any plans to enter India? Probably not. We were talking to a company in India for our Phase I trials and subsequently the project could not take off. The company we were talking to could not express the project in a way we wanted that to be. But on a long-term view, we can't rule out the possibility of entering India entirely. Globally, there has been a spate of mergers and acquisitions. How do you see these? It is a good sign. For companies that are small and big, sound customer base, good technical expertise, etc. could be exchanged and transferred for better productivity and reach. Sunitha Natti, CyberMedia News, Hyderabad ]]> <![CDATA["We are now looking to bring in the recombinant business to India" - Raj K Sachdev, manager, technical operations, Baxter Healthcare Corp.]]> https://biospectrumindia.com/news/95/2813/we-are-now-looking-to-bring-in-the-recombinant-business-to-india-raj-k-sachdev-manager-technical-operations-baxter-healthcare-corp-.html https://biospectrumindia.com/news/95/2813/we-are-now-looking-to-bring-in-the-recombinant-business-to-india-raj-k-sachdev-manager-technical-operations-baxter-healthcare-corp-.html Mon, 11 Apr 2005 16:36:00 +0530 How is Baxter faring in India? What are your India plans? Baxter has some of its units in India. And we are now looking to bring in the recombinant business to India. And we are trying to get hold of some clients for contract manufacturing, who can basically make some drugs at our facility. How do you foresee the growth of Indian biotech industry? We are doing well with whatever products that are being marketed in India. And this is only improving. That India is a growing market for biotech is not necessarily true only for Baxter but for all biotech companies in the Western world. Eventually, this will turn out to be the most sought-after place for clinical trials and R&D work. The trickle has started and there's more to be tapped. With concerns raised by companies on India's preparedness to meeting the global standards, what kind of work can the Indian companies target for? Right now India can fare well in generic drug manufacturing. Several countries smaller than India like Israel are operating in this space. The expertise is here, and India can make them at a lot cheaper rate. When talking about the regulatory practices, more and more companies are gearing up to meet the standards and since generic drugs don't have any IP being involved, this is a good thing to strike the chord. As the cost of healthcare has gone up drastically in the US and across the world, it would be specially good for India to manufacture these drugs. ]]> <![CDATA["India is on the threshold of the global biotech radar" - Stephen F Gorfien, director, industrial applications, cell culture research and development, Invitrogen Corporation.]]> https://biospectrumindia.com/news/95/3023/india-is-on-the-threshold-of-the-global-biotech-radar-stephen-f-gorfien-director-industrial-applications-cell-culture-research-and-development-invitrogen-corporation-.html https://biospectrumindia.com/news/95/3023/india-is-on-the-threshold-of-the-global-biotech-radar-stephen-f-gorfien-director-industrial-applications-cell-culture-research-and-development-invitrogen-corporation-.html Mon, 11 Apr 2005 16:34:00 +0530 How are Invitrogen products and business faring in India? We have a variety of products like protein-to-protein interactions, reagents, and chemically defined agents. Many of these are animal-origin-based. So they are very useful for the processes that are concerned with regulatory issues. This business is growing. Biotechnology in India is beginning to exploit quite rapidly. We are already in contact with a few industrial customers and I am beginning to meet many of them as well. Further, some of the academic customers that we already have help us to expand our presence. What are your plans for India? We already have good business presence the world over and we are constantly working to improve it further. As far as R&D centers are concerned, we have many of them across the US and Europe. We have now started to build R&D centers across the world. In this attempt, we are now setting up an R&D center in India too. The infrastructure already exists in Bangalore, we just need to get in some people and start the development activity shortly. What is your opinion on India's preparedness in improving its manufacturing facilities and GMP practices? There are certain companies that are doing quite well and they are building facilities for processes to be able to compete on a global scale. And the number of such companies seems to be growing much faster than earlier. Certainly, the country is on the threshold of the global biotech radar. What are some of the immediate things that the Indian biotech companies need to concentrate upon? Paying attention to the regulatory bodies in compliance with the US and European markets is the need of the hour. Equally, there are certain things that need to be followed in terms of product development so as to get their products accepted in their chosen market. ]]> <![CDATA["I am impressed by the quick transformation happening in India," - Cory Card, senior development team leader, R&D, HyClone]]> https://biospectrumindia.com/news/95/1742/i-am-impressed-by-the-quick-transformation-happening-in-india-cory-card-senior-development-team-leader-rd-hyclone.html https://biospectrumindia.com/news/95/1742/i-am-impressed-by-the-quick-transformation-happening-in-india-cory-card-senior-development-team-leader-rd-hyclone.html Mon, 11 Apr 2005 16:32:00 +0530 How has the merger with Millipore affected the fortunes of Hyclone? It was not a merger we had with Millipore. It is simply a partnership with them on certain products to be used together. In fact, the life sciences division of Fisher acquired us way back in August 2003. Can we expect the partnership with Millipore to turn into a single entity? No. Actually, we had similar partnerships with a lot of other companies as well and still remain as separate entities eventually. We leverage the product base of both companies and try coming out with products jointly benefiting users. What is your feedback on the Indian industry? It is quite good. We are presently with two Indian distributors. We have had some really good successes through them. But now I am seeing personally how Indian biotech industry has come of age. I am impressed by the quick transformation happening here and with certain things like IP protection and regulatory issues given due importance, there would be much more development taking place. What are the new products and technologies being worked upon? We are presently working on some of the major next generation platforms for gene therapy, vaccine production etc. Besides we also enter into strategic alliances with other companies to exchange and transfer the product base and technology. ]]> <![CDATA[Chromosome X unraveled]]> https://biospectrumindia.com/news/95/1616/chromosome-x-unraveled.html https://biospectrumindia.com/news/95/1616/chromosome-x-unraveled.html Mon, 11 Apr 2005 16:31:00 +0530 An international team led by the Wellcome Trust Sanger Institute, Cambridge, UK has succeeded in coming up with complete analysis of the X chromosome. "From studying such genes, we can get remarkable insight into disease processes. We have also gained a deep insight into the evolution and biology of the whole chromosome. We can see the way evolution has shaped the chromosomes that determine our gender to give them their unique properties", said Mark Ross, project leader at the Wellcome Trust Sanger Institute. In humans and other mammals, sexual identity is governed by a pair of chromosomes known as X and Y. Every female has two X chromosomes, inherited from both parents, while all males have one X from the mother and one Y chromosome from the father. As a result, any defects in genes on the X chromosome are often apparent in males because the Y chromosome does not carry corresponding genes to compensate. Women who carry such defective genes are usually protected by their backup copy of the X. The X chromosome was originally named X for "unknown", remaining an oddity that has puzzled geneticists for centuries. The complete sequencing has enabled the researchers to construct a remarkably detailed portrait of the X's past. The study has shown how both the chromosomes, X and Y evolved from an "ordinary" pair of identical chromosomes. After the X and Y seceded, mutations in genes on Y made it the male determining chromosome. Over time Y has disintegrated to a shadow of its former self. More than 300 diseases have been mapped to the X chromosome, by far the highest proportion of any chromosome, including Duchenne Muscular Dystrophy and Haemophilia, in which the blood fails to clot properly. The primary sequence of this chromosome is an advanced starting point for exploring the mysteries of evolution and development. As Professor Allan Bradley, Director, Wellcome Trust Sanger Institute, remarked, "We often describe the results of sequencing as a 'catalogue of human genes'. The results of projects such as the finished X chromosome are so much more than that. They are the forces that will drive biomedical advance in the UK and around the world." n ]]> <![CDATA[Cardiac patients get stem cell therapy at AIIMS]]> https://biospectrumindia.com/news/95/1322/cardiac-patients-get-stem-cell-therapy-at-aiims.html https://biospectrumindia.com/news/95/1322/cardiac-patients-get-stem-cell-therapy-at-aiims.html Mon, 11 Apr 2005 16:30:00 +0530 Stem cell therapy has become a reality in India. The All India In stitute of Medical Sciences (AIIMS) has successfully given stem cell treatment by 'injection method' to its cardiac patients. The institute conducted the study under the leadership of P Venugopal, a renowned heart surgeon and AIIMS, director, from February 2003 to January 2005, where 35 cardiac patients were given stem cell therapy and were monitored at six, 12, and 18 month intervals. All the patients were brought in at a stage when their hearts were beyond bypass surgery and transplant was the only solution. During the course of the treatment, there were no mortalities and in fact after six months, 56 percent of the dead tissue area injected with stem cells showed improvement. After eighteen months, the improvement spread to about 64 percent of the necrotic tissue area. These stem cells, derived from the patient or donors, act as repair agents within the body, multiplying continuously to replenish other cells. The procedure uses robotics to inject stem cells into the artery leading to the diseased organ, after blocking passage through the vein to prevent loss in transit, in patients. The regenerative cells are delivered to the affected area initiating the process of repair and regrowth of healthy cells. This reduces the disease burden in some while completely curing others. Besides cardiac patients, the stem cell injection method can also be successfully used in patients with diabetes, neurological disorders, muscular dystrophy and cerebral palsy. With further refinement, even immune disorders and cancer can be treated with this stem cell procedure. Commenting about this achievement, the Union health and family welfare minister, Anbumani Ramadoss said, "The feat had placed AIIMS right at the top of the world's medicine map." This achievement has brought new laurels to AIIMS, as this is a global first in stem cell medicine. AIIMS has now been notified as India's nodal center for conducting and coordinating stem cell research. The medical team can file for a patent as this procedure is one of its kind even though stem cell technology has been applied successfully in the UK, Korea and China, particularly in regenerating diseased cells. In fact, this treatment procedure is so new that there are no clear regulatory guidelines for carrying out stem cell transplants on heart patients undergoing bypass surgery. This has led to fears that soon this may lead to a number of private health centers claiming stem cell treatment for a wide range of diseases. ]]> <![CDATA[Dengue diagnosis made easy]]> https://biospectrumindia.com/news/95/5268/dengue-diagnosis-made-easy.html https://biospectrumindia.com/news/95/5268/dengue-diagnosis-made-easy.html Mon, 11 Apr 2005 16:28:00 +0530 Currently, dengue fever is the most important re-emerging mosquito-borne viral disease, with the major proportion of the target population residing in the developing countries of the world. It is one of the leading public health concerns in over a hundred tropical and sub-tropical countries in South East Asia, the Caribbean, Central and South America. The World Health Organization (WHO) receives reports of about 5,00,000 dengue fever cases each year, but estimates that as many as 50 million people are infected annually. Dengue is a mosquito-borne (Aedes aegypti), positive-stranded RNA virus of the genus Flavivirus. About 40 percent of the global population is estimated to be at risk of dengue infections. There are four antigenically distinct serotypes of dengue virus (DEN-1, 2, 3 and 4). The infection is accompanied with raging temperature and the agonizing limb pains that have earned the disease its sobriquet 'break-bone fever'. In addition, some patients lose hair and develop a measles-like rash, bleeding gums and depression that can last for weeks. In a small percentage of cases, mostly in infants, the infection causes dengue haemorrhagic fever (DHF) which is fatal. Dengue diagnosis Dr Navin Khanna, senior scientist and group leader, Recombinant Gene Products Lab, ICGEB, along with his team has developed a novel recombinant dengue multi epitope protein that exhibit potential for early detection of dengue infection. Dr Navin Khanna Accurate dengue detection proves to be elusive as very often the diagnosis of dengue in endemic regions is based on clinical presentation, and can be confused with other viral diseases with similar clinical features like Japanese Encephalitis and yellow fever. This underlines the importance of laboratory-based diagnostic tests in providing timely medical attention. Most of the currently available commercial dengue diagnostic kits rely on the use of whole virus antigens and are consequently associated with false positives (due to serologic cross-reactivity with other flavi viruses), high cost of antigen production, and biohazard risk. Additionally, sera from patients with typhoid, malaria and leptospirosis also tend to score positive using these kits. This prompted the need to develop an alternate antigen to replace the whole virus antigen in diagnostic tests. To address the need for developing cost-effective, simple and rapid diagnostics that combines sensitivity and specificity, Dr Khanna and his team explored the option of synthetic protein antigens containing dengue virus specific epitopes that are not present in other viruses. The scientists chose 15 'unique' epitopes containing about 300 amino acids on the basis of pepscan analysis, phage display, and computer predictions, which were "stitched" together. In this way, the group designed and expressed novel recombinant protein antigen by assembling key immunodominant, linear, conserved, dengue virus epitopes. The recombinant protein was expressed to high levels in the bacterium Escherichia coli, purified in a single step, yielding more than 25mg pure protein per litre culture. In order to detect its efficacy, the researchers then developed an in-house Enzyme-Linked ImmunoSorbent Assay (ELISA) to detect anti-dengue antibodies in a panel of 170 patient sera using the purified recombinant proteins as the capture antigen. The ELISA results were found to be in excellent agreement with those obtained using a commercially available diagnostic test. Efforts are being made to evaluate its performance with more sera samples. Dr Khanna elaborated that since the epitopes were chosen very carefully, the chance of false positives was very less. "The high epitope density, careful choice of epitopes, and the use of E. coli system for expression, coupled to simple purification, jointly have the potential to lead to the development of an inexpensive diagnostic test with a high degree of sensitivity and specificity". Dr Khanna and his colleagues have got a patent on the diagnostic intermediate. Dengue has been a neglected disease and is popularly known as Malaria's poor cousin, but the consciousness to combat is steadily increasing. The biggest bottleneck in developing a good kit is the lack of a well-characterized dengue sera panel. In fact Dr Khanna had to test the recombinant protein against the sera panel in Sri Lanka, as such a panel is practically non-existent in India. Now the Department of Biotechnology (DBT) has identified the need of a 'gold standard' sera panel against dengue in the country. Institutes like NICS (National Institute of Clinical Studies), NIV (National Institute of Virology), AIIMS (All India Institute of Medical Sciences), ICGEB (International Centre for Plant Engineering and Biotechnology), MAMC (Maulana Azad Medical College) are expected to spearhead this effort. Dengue vaccine The existence of multiple but distinct dengue virus serotypes is a major factor that has hindered vaccine development efforts. Available evidence indicates that immunity against an infecting serotype is life-long, whereas cross-protection against other serotypes is transient. Protection against only one or two dengue viruses could actually increase the risk of potentially fatal dengue haemorrhagic fever and dengue shock syndrome. Thus, sequential infection in endemic areas, where multiple serotypes co-circulate, has the potential to trigger life-threatening disease. Therefore, a safe and effective dengue vaccine should ideally be "tetravalent" or capable of providing solid and long-lasting immunity to all four serotypes. Currently, in the world six different virus-based vaccines are in various stages of development. Dr Khanna and his group are working on a DBT-funded project to develop a vaccine against dengue. They are investigating the possibility of developing sub unit vaccine candidates using yeast and adeno-viral vector systems. n Rolly Dureha ]]> <![CDATA[Industry-friendly Biotech Policy Unveiled]]> https://biospectrumindia.com/news/95/2115/industry-friendly-biotech-policy-unveiled.html https://biospectrumindia.com/news/95/2115/industry-friendly-biotech-policy-unveiled.html Mon, 11 Apr 2005 16:27:00 +0530 The policy, called the National Biotechnology Development Strategy, was unveiled by Sibal and Bhan on March 31. The draft policy has been made public to invite wide comments. A quick reading indicates that it is clearly an industry-friendly policy with most of the major demands of the industry finding prominent mention in it. BioSpectrum had pro-actively sought the policy maker's attention to the demands of the industry in the last two years and the BioSpectrum Awards Nite on December 10, 2004 in Bangalore was one of the forums for a lively discussion on the policy draft. "We want the Biotech Strategy to be the road map for the next ten years in this sector. It aims to make the processes easier, quicker and friendly for the common man. The policy will provide adequate support to basic, translational and clinical research. Up to 30 percent of biotechnology research budget (of Rs 200 crore) will be spent through public-private partnerships," Sibal said. Regarding regulatory approvals for the biotech sector, he commented, "This (regulatory approvals) is on top of the agenda to make approvals a lot more simpler and faster. The recommendations of the Swaminathan Committee for agri-biotech and the Mashelkar Committee for bio-pharma would be implemented and the effort will be to train scientists and technology transfer professionals in handling Intellectual Property Rights issues. Regional technology transfer cells will be created to provide high caliber, specialized and comprehensive technology transfer services." Dr Bhan said, "We have two goals. One is to benefit the ordinary people and help the country's development. The other is to promote innovation." "A major aim of the Strategy is the development of human resources. We plan to set up centers of excellence in the fields of marine biotechnology, animal biotechnology, herbal medicine, molecular medicine and bio-informatics," he added. A major policy statement is the announcement that there will be no restriction on the quantum foreign direct investment (FDI) in biotech companies. Sibal and the policy clarified that there "may not be the need for FIPB (foreign investment promotion board) approval for equity investments in biotech companies." n N Suresh and Rolly Dureha Highlights from the draft The Indian Biotechnology sector is gaining global visibility and is being tracked for emerging investment opportunities. Human capital is perceived to be the key driver for global competitiveness. Added to this is a decreasing appetite for risk capital in developed countries, which has led to a decline in the biotechnology sector in these regions where survival lifelines are being provided by the lower cost research environs of the developing world such as India. For a country like India, biotechnology is a powerful enabling technology that can revolutionize agriculture, healthcare, industrial processing and environmental sustainability. The Indian biotechnology sector has, over the last two decades, taken shape through a number of scattered and sporadic academic and industrial initiatives. The time is now ripe to integrate these efforts through a pragmatic National Biotechnology Development Strategy. It is imperative that the principal architects of this sector along with other key stakeholders play a concerted role in formulating such a strategy to ensure that we not only build on the existing platform but expand the base to create global leadership in biotechnology by unleashing the full potential of all that India has to offer. BioAgriculture Transgenic plants should not be commercialized in crops/commodities where our international trade may be affected. However, their use may be allowed for generation of proof of principle, strictly for R&D, their alternate systems are not available or not suitable. Biotechnology can deliver the next wave of technological change that can be as radical and even more pervasive than that brought about by IT. Employment generation, intellectual wealth creation, expanding entrepreneurial opportunities, augmenting industrial growth are a few of the compelling factors that warrant a focused approach for this sector. However, emphasis should not be on edible vaccines for which use in real life condition is difficult. Nutrition and balanced diet are emerging to be important health promotional strategies. Biotechnology has a critical role in developing and processing value added products of enhanced nutritive quality and providing tools for ensuring and monitoring food quality and safety. A precautionary, yet promotional approach should be adopted in employing transgenic R&D activities based on technological feasibility, socio-economic considerations and promotion of trade. Fiscal and trade policy initiatives Biotechnology firms are by far the most research intensive among major industries. On an average, the biotechnology sector invests 20-30 percent of its operating costs in R&D or technology outsourcing. Government support, fiscal incentives and tax benefits are therefore critical to this sector. These measures will also help to capitalize on the inherent cost effectiveness of the Indian biotech enterprise. The suggested interventions include: â€¢ Exemption of import duties on key R&D, contract manufacturing/clinical trial equipment and duty credit for R&D consumer goods to enable small and medium entrepreneurs to reduce the high capital cost of conducting research. â€¢ Extending the 150 percent weighted average tax deduction on R&D expenditure under section 35 (2AB) until 2010 and to permit international patenting costs under this provision and enable eligibility of expenditure incurred with regard to filing patents outside India for weighted deductions u/s 35 (2 ab) â€¢ Enable lending by banks to biotech companies as priority sector lending. Currently banks are almost averse to lending to young biotech companies. In order to encourage banks to lend and provide banking services to the biotech sector, a significant push through appropriate policy guidelines from the Reserve Bank of India is necessary. Currently lending to agri-businesses as well as investment in Venture Funds by banks is categorized as Priority Sector Lending. Biotech as a business has similar characteristics in terms of risk as well as gestation time lines and it is therefore recommended that lending to Biotech be also categorized as Priority Sector lending. â€¢ Remove customs duty on raw materials imported into India, where the finished product is imported duty-free. Life Saving Drugs imported and sold in India are exempted from paying customs duty; whereas raw materials for diagnostics and other pharmaceutical biotech products manufactured in India are levied customs duty. To promote the indigenous manufacturing industry and make it competitive globally, raw materials imported by Indian manufacturers should be eligible for Duty Drawback. â€¢ Rationalization of import and export of biological material is considered critical for clinical research and business process outsourcing. â€¢ Simplification and streamlining of procedures for import, clearance and storage of biologicals, land acquisition, obtaining environmental and pollution control approvals would be simplified and streamlined within shorter time frame lines through consultations with various central and state government departments. â€¢ As an effective regulatory mechanism has been put in place though recent interventions, Foreign Investment Promotion Board (FIPB) approval for equity investment may no longer be necessary. â€¢ Joint R&D collaboration and generation of joint IP through global partnerships would be fostered. â€¢ International trade opportunities would be promoted to guide R&D investment Indian biotech strengths would be aggressive by promoted globally. â€¢ Efforts would be made to remove hurdles for contract research especially for input output norms and tax on revenue generated through contract research/R&D. â€¢ Easy access to information, regarding legislation and rules and regulations for transboundary movements of biologicals would be promoted. â€¢ Current standards and safety of products would be enhanced. â€¢ Efforts would be strengthened to promote acceptance of Indian regulatory data internationally. â€¢ Research, trade and industrial partnership would be fostered at regional and sub-regional levels. â€¢ A "cluster" approach would be encouraged to operations. One significant feature of the industry is the fluidity and variety of its inter-company relationships, traditionally much greater than in other industries. It has relied to a considerable degree on contracting and outsourcing, especially "upstream" in R&D through various licensing arrangements and "downstream" through co-marketing agreements. â€¢ Collaborative knowledge networks would be promoted. Expanded sharing of information, including creation/use of collaborative knowledge networks (CKN), can greatly enhance a company's performance under a cluster approach. Managing the many external relationships is complex. Flexible and pervasive communications systems that allow information to flow effortlessly within and between contracting organizations will provide the key to success. Increasingly, IT advances, including web-based approaches, will provide the foundation for these systems. Financial incentives Availability of financial support for early phase of product development to establish proof-of-principle is the key to sustaining innovation. In this context, it is proposed to institute 'Small Business Innovation Research Initiative' (SBIRI) scheme through the Department of Biotechnology in 2005-06 for supporting small and medium size enterprises as a grant/loan. Companies with up to 1000 employees will be eligible. The scheme will support pre-proof of concept, early stage innovative research and provide mentorship and problem solving support in addition to the grant/soft loan. The SBIRI scheme will operate in two phases of innovation and product development. Biotech Parks â€¢ The Department of Biotechnology will promote and support at least 10 biotech parks by 2010. Each park will necessarily meet the qualifying criteria related to the characteristics of the location, a viable business plan, management strategy and a clear definition of the partners and their roles. â€¢ The Department of Biotechnology will support creation of incubators in biotech parks promoted by a private industry or through public-private partnership in the form of grant upto 30 percent of the total cost or upto 49 percent in the form of equity. â€¢ It is proposed that a central body Biotechnology Parks Society of India (BPSI) be set up for the promotion of biotechnology parks in the country on the same lines of the Software technology Parks of India (STPI). The BPSI should be run by professionals having experience in the areas of biotechnology, knowledge in Acts and Rules relevant to biotechnology and management skills. The existing parks can become members of these new biotech parks. The BPSI would be responsible for evaluating the project proposals and advising the Department of Biotechnology on the funding pattern; facilitating industries in obtaining industrial, environmental and other relevant approvals from the central government; making recommendation regarding fiscal incentives to be granted to the biotechnology parks; providing guidance to the venture capital institutions on investment in biotech parks; providing accreditation to the parks etc. â€¢ Concessions to biotech companies located in biotech parks Biotech companies located at biotech parks are eligible for benefits as per the recent changes in the Foreign Trade Policy: â€¢ Duty free import of equipment, instruments and consumables. â€¢ Tax holiday under Section 10A/ 10B of the Income Tax Act A scheme will be put in place for operationalizing of the incentives to biotech units located in biotech parks. As a part of this scheme biotech company located in biotech parks to be allowed a five-year time frame to meet the export obligation norms under the SEZ scheme. This measure helps to address the long and unpredictable gestational time lines that are inherent to biotech product development. Regulatory mechanisms â€¢ The recommendation of the Swaminathan Committee on regulation of agri-biotech products and of the Mashelkar committee on recombinant pharma products will be implemented in 2005 â€¢ A competent single National Biotechnology Regulatory Authority be established with separate divisions for agriculture products/transgenic crops, pharmaceuticals/drugs and industrial products; and transgenic food/feed and transgenic animal/aqua culture. The authority is to be governed by an independent administrative structure with common chairman. The inter-ministerial group will evolve suitable proposals for consideration of the government. â€¢ A center for in-service training of all professionals, irrespective of their location, engaged in the regulatory process to be established by the Department of Biotechnology in close collaboration with other concerned departments and institutions. â€¢ All existing guidelines to be updated and made consistent with the recommendations of the Swaminathan and Mashelkar committees in 2005. New guidelines on transgenic research and product/process development in animal, aqua culture, food, phyto-pharma and environmental application to be put in place in 2005 by the concerned ministries/departments As an interim measure, a special regulatory cell will be created by the DBT to build capacity in the country for scientific risk assessment, monitoring and management, to foster international linkages, support biosafety research; to obtain and review feedback from different stakeholders and provide support to industry and R&D institutions. This cell will only have a promotional and catalytic role â€¢ It is recommended that an event that has already undergone extensive biosafety tests should not be treated as a new event if it is in a changed background containing the tested and biosafety evaluated "event". Where adequate evidence is available that the recurrent parent genetic background of a notified/registered genotype is nearly restored (through field data/molecular data), only the agronomic performance and the level and stability of the transgene expression may be analyzed by two-year trial data by the ICAR. Even in case of a structurally altered transgene with no significant modifications in protein conformation, the toxicity and allergenicity tests need not be carried out provided the predicted antigenic epitope remains the same and the level of expression of the transgene is within the defined limits. For the released event, Department is of the view that there is no need of large-scale trials under the Genetic Engineering Approval Committee, as the biosafety aspects have been already addressed adequately before releasing the "event". Only ICAR trials may address the agronomic evaluation of the crop. Create a cadre of resource persons Creation of a cadre of resource persons to provide credible information based on scientific data Training media personnel through Institutes of Mass Communication, colleges of journalism and others Capacity building among extension personnel in agricultural, fisheries, veterinary and medical sectors Involvement of Panchayati Raj institutions in the process of analysis and understanding the risks and benefits associated with GMOs as they will be playing an important role in the local level management of bio-diversity, access to benefit sharing etc. Awareness generation among undergraduate and post-graduate students in universities, colleges etc on issues related to biosafety. Promoting a genetic literacy movement within government and public schools through 50 genome clubs nature clubs each year. Empowering the judiciary Setting up a training school for the judiciary under the aegis of Center for DNA Fingerprinting and Diagnostics, Hyderabad Training through the National Law Schools and other similar institutions Institutional mechanisms for strengthening public trust Establishment of a dedicated training center for biosafety, food and nutrition safety and standards as per codex alimentarius committee Creation of a 'National Biotechnology Awareness Fund' for providing support for the education and preparation of educational resource material for various sections of stakeholders in different regional languages of the country Single Window Clearance Department of Biotechnology will act to facilitate a Single Window Clearance mechanism for establishing Biotechnology plants. Encourage private participation in infrastructure development like roads, water supply and effluent treatment. Depositories of biological materials will be created in partnership with industry on IDA model for agriculturally important organisms, medically important organisms, plasmids, cosmids and constructs of special nature generated with adequate human interventions State of the art large animal house facilities with GLP will be created for testing candidate vaccines and biotherapeutics. Testing facilities will be created for GMO/LMO Innovation Basic and translational research in key biological processes and new materials will be supported as innovation for tomorrow. Access to the knowledge generated will be improved by supporting knowledge and social networks among stakeholders so that those with appropriate skills can convert the research output into useful products and processes. Research to promote innovation must be supported increasingly on a cooperative rather than a competitive basis. This requires effective communication among science agencies, research institutions, academia and industry. To promote India as a hub of innovation, a network of relevant stakeholders should be developed. Public investment should be used as a catalyst to promote such clustering and networking as this can lead to enhanced creativity by sharing of expertise, resources and infrastructure. Availability of human resource would be ensured at each phase of the product cycle. Strengthening technology transfer capacity It is proposed to create several national/regional technology transfer cells (TTCs) over the next five years to provide high caliber, specialized and comprehensive technology transfer services. The services would include evaluating technology and identifying potential commercial uses, developing and executing and intellectual property protection strategies identifying potential licensees and negotiating licenses. Each TTC would service a cluster of institutions in a region or a large city. National Task Force on education & training A National Task Force will be created to formulate model undergraduate and postgraduate curricula in Life Sciences keeping in view, future needs. The said curricula must address the underlying need for multi-disciplinary and inter-disciplinary learning and the appropriate stage for biotechnology training. Need assessment There would be need assessment in 2005 for the next five years and close monitoring during the period for interim changes. ]]> <![CDATA[Borlaug awards for Dr S Nagarajan and Dr Rattan Lal]]> https://biospectrumindia.com/news/95/8324/borlaug-awards-for-dr-s-nagarajan-and-dr-rattan-lal.html https://biospectrumindia.com/news/95/8324/borlaug-awards-for-dr-s-nagarajan-and-dr-rattan-lal.html Mon, 11 Apr 2005 16:23:00 +0530 Dr S Nagarajan, director of the Indian Agricultural Research Institute (IARI) and Dr Rattan Lal, professor of Soil Science at the Ohio Dr S Nagarajan State University, Columbus, USA, have been selected for the Borlaug award for the year 2005. The prestigious award is given annually to honor and recognize outstanding research and contributions in the field of agriculture, environment and extension by Indian scientists. The Borlaug award was instituted by the Coromandel Fertilizer of the Murugappa Group in 1972 to honor Nobel laureate Dr Norman E Borlaug, who is responsible for the wheat revolution in India. Dr S Nagarajan, who is internationally respected as a wheat pathologist, has been recognized for his contribution to the advancement of the wheat program, pathology of wheat rusts and its elimination, and as an educator. Dr Rattan Lal has been selected for his work in soil sciences and integrated natural resource management. He is known for his research and development activity that has helped significantly to reduce global food insecurity by increasing the understanding of the nature of soil, importance of soil healthcare. Three Indians among finalists for Asia-Pacific BioBusiness Award Dr Krishna M Ella, Dr Swati Piramal and Dr Prathap C Reddy are among the finalists of the Asia-Pacific BioBusiness Leadership Award 2005 to be presented at its annual Asia-Pacific Business Outlook Conference on April 7, 2005. Dr Prathap C Reddy The award recognizes leaders (individuals, organizations and corporations) that best exemplify the spirit of innovation, enterprise and entrepreneurship in areas of biobusiness (healthcare, biomedical, agricultural, food, environmental and emerging technology areas in the life sciences and biotechnology). This award is the first in a series of regional and global BioBusiness Leadership Awards. This award program underlines the USC Marshall School's strong international focus, and its commitment to business excellence, innovation, and leadership. The other finalists for the award are Dr Joong-Myung Cho (Korea), former R&D director, LG Chemicals and Yoh-Chie Lu (China/Singapore/USA), founder of Biosensors. Padma awards presented President A P J Abdul Kalam gave away the prestigious Padma Awards for 2005 at a glittering ceremony at the stately Durbar Hall of Rashtrapati Bhavan in New Delhi on March 28, 2005. The awardees included seven leaders from the biotech industry and five of them happen to be the captains of biotech and life science companies. Out of the 96 Padma awardees, seven are business people - Dr Bhai Mohan Singh of Ranbaxy, Kiran Mazumdar-Shaw of Biocon, Varaprasad Reddy of Shantha Biotechnics, Dr Yusuf Khwaja Hamied of Cipla, Dr Cyrus Soli Poonawalla of Serum Institute of India, Azim Premji of Wipro and Dr Brijmohan Lall Munjal of Hero. The profile of the biotech industry has been further enriched with awards presented to Dr Martanda Varma Sankaran Valiathan (Padma Vibhushan) and Prof V S Ramamurthy, secretary, Department of Science & Technology (Padma Bhushan). Indian researcher excels Dr S Nagarajan Ashwin Sivakumar, a research fellow at the Institute of Biotechnology, University of Helsinki, has been selected amongst the 100 most promising young scientists and MBAs from the life sciences sector worldwide by Biovision and Science. He will be in the class of 2005 participating in Biovision.Nxt event, a part of world life science forum to be held in April this year. Ashwin's research focuses on multiple themes: First theme being dealing with function classification systems and study of diverse super-families using comparative genomic approaches. His parallel area of research deals with management and strategy issues in the biotech sector. ]]> <![CDATA[NEWS BYTES APRIL05]]> https://biospectrumindia.com/news/95/2709/news-bytes-april05.html https://biospectrumindia.com/news/95/2709/news-bytes-april05.html Mon, 11 Apr 2005 15:58:00 +0530 Ranbaxy partners with Novavax Ranbaxy Laboratories, Inc., a wholly-owned US subsidiary of the Indian pharmaceutical giant has entered into an agreement with Novavax Inc., a specialty biopharmaceutical company, to evaluate a new transdermal product. This product has been formulated using Novavax's proprietary Micellar Nanoparticle (MNP) technology. Speaking about the agreement, Nelson M Sims, president and CEO, Novavax Inc., said, "This agreement demonstrates the merits of our MNP technology to other companies as a value-added proprietary delivery technology for novel drug candidates. This is an example of the commercial and development opportunities micellar nanoparticle technology offers Novavax and our partners". Though the specific terms of the agreement are confidential, Ranbaxy's payment to Novavax includes funding to complete a proof of concept study. Upon successful completion of the proof of concept study, the companies expect to enter into a broad commercialization and development agreement. Wipro, Sun to offer integrated package for biotech fraternity Wipro Infotech has announced that it would be offering ready-to-run bioinformatics applications powered by Sun workstations and servers. According to a press release, the package would include the BioWorkstation and BioCluster, which would provide life science organizations, with ever increasing needs of computing power, an ability to harness a group of interconnected processors delivering availability and scale. Speaking on this offer, Wipro Infotech enterprise platforms GM Ashok Tripathy, said, "The benefits of using this package are manifold. Firstly, users can focus on using these applications rather than spending time setting them up. Secondly, better time utilization will result in quality research and increased productivity. Third, the return on IT infrastructure will be much greater because of improved system utilization. Lastly, there will arise lots of opportunities for collaboration as a result of an expanded user base for bio-computing applications." - CyberMedia News Glenmark Labs inks pacts with TASC Pharmaceuticals Glenmark Laboratories Limited, a niche formulation and biopharmaceutical player, has announced an integrated alignment pact with TASC Pharmaceuticals Ltd, a research driven API Company. The combined entity will be an integrated player both in pharmaceuticals (based on chemical substances) and biopharmaceuticals (based on biologics) with presence over entire value chain and is valued at over Rs 1,200 crore. Mark Saldhana, managing director, Glenmark Labs said, "Companies that are fully vertically integrated, having presence in the entire value chain and having global presence offering bouquet of niche products will be better positioned in the new scenario and our amalgamation pact with TASC will not only allow us to backward integrate in terms of our API requirements but also allow us to enhance our true potential due to wider product basket, better market access, leading position and comprehensive R&D capabilities." Helix licenses biological software suite to CMSD Helix Genomics Pvt Ltd (HGPL), a Hyderabad-based bio-computational research and software development company, has announced the licensing of its premiere biological software suite, Biological Operating System (BOS) to the Centre for Modelling, Simulation and Design (CMSD) at the University of Hyderabad. BOS is believed to be the first of its kind among the existing biological softwares and is unique in being the higher-level user friendly Object Oriented Biological Programming Environment (O2-BPE). BOS is indigenously developed and patented technology from Helix Genomics. Explaining the license, Mohan R K Nimmagadda, CEO, Helix Genomics Pvt Ltd, said the bio-researcher is offered a user-friendly software environment enabling timely and efficient implementation of research projects. The license has been extended to cover all the research labs at the School of Life Sciences, University of Hyderabad. This will facilitate in building long term research collaboration with HGPL delivering better and faster computational solutions. Stress on need to double food production by 2050 January 2005 marked the official beginning of a year-long celebration commemorating the 100th anniversary of Indian Agricultural Research Institute (IARI). The institute organized a three-day scientific convention as part of its centenary celebrations this month. The key attraction was Dr Borlaug's Coromandel Lecture "From the Green to the Gene Revolution: A 21st Century Challenge". "Since 1997, per capita production of wheat has been declining because of the emergence of new diseases, such as stem rust. If we can use modern biotechnology tools to transfer rust resistance in rice to wheat, it would make a huge contribution to farmers," Dr Borlaug said. He observed, "There is to need to double food production by 2050 if hunger is to be banished from the world and the ongoing 'gene revolution' can definitely play a part in this." Two Indian journals in list of prior art journals In a major breakthrough, for the first time two scientific journals from developing countries, in particular from India, have been included in the coveted list of the prior art journals used for prior art search before grant of patent(s) by the International Search Authorities. So far journals from some of the developed countries only were included in the prestigious list. The World Intellectual Property Organization has informed that in the meeting of the international authorities held under Patent Cooperation Treaty (PCT), it has been unanimously decided to include India journals, namely, Indian Journal of Traditional Knowledge (IJTK) and Medicinal and Aromatic Plant Abstracts (MAPA) in the Non Patent Literature (NPL) part of the PCT Minimum Documentation. Tata Motors, IOC tie up for bio-diesel Tata Motors has begun a pilot program to use bio-diesel for its fleet of buses, a project jointly undertaken with the Indian Oil Corporation (IOC). A petrol pump, exclusively dedicated for bio-diesel was unveiled and a fleet of 43 buses was flagged off from the Tata Motors facilities in Pune. MITS plans Jatropha plantations Orissa-based Majhighariani Institute of Technology (MITS) is planning massive Jatropha plantations in 13 districts in Orissa covering over a lakh of hectare of wasteland for bio-diesel. The institute has set up a laboratory at Raigada where it is going to process it and convert it into bio-fuel. The project is estimated to cost Rs 500 crore. The institute is under the patronage of Basantidevi Charitable Trust (BCT) based in Raigada district. Dr Reddy's bag $56 m funding Dr Reddy's Laboratories has entered into a $56-million agreement with ICICI Venture Funds Management Company for the development and commercialization of ANDAs to be filed in 2004-05 and 2005-06. ICICI Venture will fund the development, registration and legal costs on a pre-determined basis. Dr Reddy's will pay ICICI Venture royalty on net sales for a period of five years. - CyberMedia News Take Solutions to launch life sciences BPO Take Solutions, a technology enabled business solutions company, is all set to launch a new BPO for the pharmaceutical and biotech industry, by the end of December 2005, in Chennai. Take Solutions CEO Ram Yeleswarapu said, "Pharmaceutical companies, from June 2005 are required to provide the United States' Food & Drug Administration (FDA) all products information in XML format in compliance with the structured product labeling (SPL) standard. This BPO division would help both the pharma and biotech manufacturers satisfy the FDA norms. Besides, it will also benefit the Indian pharma and biotech exporters, to meet the FDA norms." He added that Take's new product range, Submit SPL, a cost effective, reliable and smart way to produce labels in the FDA compliant format, which was launched two months ago in the US received a good response from among the pharma manufacturers. With a current employee base of around 400, Take Solutions intends to increase its headcount to 500, an addition of 100 with the launch of BPO service in the life sciences domain. Vidyalakshmi P S, CyberMedia News Biovitrum acquires Cambridge Biotechnology Biovitrum has agreed to acquire Cambridge Biotechnology Ltd, a Cambridge UK-based private drug discovery company. Through this move, Biovitrum is developing its therapeutic area base, advancing and balancing the medical and commercial potential of the product portfolio, expanding the technology platform and strengthening its position as a leading European player. As a subsidiary of Biovitrum, Cambridge Biotechnology will continue to work as an autonomous, highly skilled and innovative R&D unit, based in Cambridge, UK. "I am really excited about this acquisition. This kicks off our new R&D strategy, it expands our therapeutic area base and specifically gives us two advanced projects with substantial potential, of which one is already in clinical phase I", said Anders Ullman, senior vice president, R&D, Biovitrum. Epimmune, IDM agree to combine businesses Epimmune Inc., a developer of vaccines for cancer and infectious diseases, and IDM SA (Immuno-Designed Molecules), a biopharmaceutical company specializing in immunotherapy for the treatment of cancer, announced the signing of a definitive agreement under which Epimmune will combine with privately-held IDM in an all-stock transaction. By combining, Epimmune and IDM expect to create a leading company in immunotherapeutics, with a broader and more mature product pipeline, nearer-term product revenue opportunities, an improved cash position, and increased visibility in the financial markets. The combined company will focus on seven product candidates in clinical development for cancer and infectious disease indications. IDM's lead product candidate, Mepact, has completed a Phase III clinical trial in the US for the treatment of osteosarcoma. The Company will also maintain strategic partnerships with Sanofi-Aventis, Medarex and Innogenetics. ]]> <![CDATA[Patents Act 1970 amended]]> https://biospectrumindia.com/news/95/1991/patents-act-1970-amended.html https://biospectrumindia.com/news/95/1991/patents-act-1970-amended.html Mon, 11 Apr 2005 15:57:00 +0530 The Rajya Sabha finally passed the Patent (Amendment) Bill 2005 on March 23, 2005, with little public debate. Succumbing to pressure from the Left, the government made amendments to the Ordinance (the new Patent Bill 2005) with no discussions to determine the effects of the amendments that have been made to it. Given the compulsions of the coalition government, the UPA government handled the Patent Bill very effectively in the Parliament for its smooth passage, thus honoring the country's commitment to comply with the TRIPS requirement. Biotechnology in the post-patent era V Lakshmikumaran, advocate, Lakshmi Kumaran & Sridharan, a Delhi-based law firm, talks about the salient features of the Bill. What are the key highlights of the third amendment to the Patents Act in relation to biotechnology? The Patents Act, 1970 has been recently amended to comply with the TRIPs agreement. One of the salient features of the amended Act is that it provides for product patents unless otherwise excluded. Plants and animals, seeds, including essentially biological processes used for propagating plants and animals are not patentable. Microorganisms, however, are patentable. The area of patentability in relation to microorganisms is not clear. Going by the US and European precedents, it would appear that only such microorganisms that are the result of human intervention would be patentable. Naturally occurring microorganisms are likely to be excluded from patentability, unless the microorganism loses its natural characteristics as a result of human intervention. Synthetic genes (as distinct from naturally occurring gene segments) too would now be the subject matter of patentability. Genetic inventions will include SNP (single nucleotide polymorphism), vectors, recombinant products such as vaccines, enzymes, hormones, etc. In order to get a patent, the Act requires the deposit of biological material with the International Depository Authority (IDA). IMT, Chandigarh, is the IDA in India for some of biological materials such as bacteria and plasmids. The amended Act severely restricts the patenting of software. This is likely to negatively impact research in bio-informatics. With the passing of the Patents Amendment Bill, Kamal Nath, Union minister of commerce and industry, said that the much awaited product patent era had dawned. India now has product patents for pharmaceuticals, agricultural chemicals and special food products. Welcoming the Patents Bill, the Indian Pharmaceutical Alliance (IPA) noted that it has struck a balance between the consumers' interest and that of innovators. "Many investors hitherto unsure of expanding operations in India, would now confidently take the plunge. Indian companies, on the other hand, need to fine tune their strategies. Foreign companies would be looking at launching their patentable products in India with the hope of a high volume driven growth in India. Indian companies in areas like biotechnology and herbal products may look now to expand their product portfolio. Indian companies will have to adopt a multi-pronged strategy to fully exploit the challenges of the new regime", the minister said. Dr Ajit Dangi, director general, Organisation of Pharmaceutical Producers of India (OPPI), noted, "India is now entering a new era and it will attract more investments, domestic as well as foreign, in R&D, foster a culture of innovation and the patients will get access to modern therapies, which were hitherto not available. The potential for outsourcing opportunities such as clinical trials, contract manufacturing, bioinformatics, custom synthesis and technical services is also tremendous." Sharing his thoughts, Habil Khorakiwala, president, IPA said, "The changes in the definition of patentability, restoration of pre-grant opposition and automatic license of right would help to maintain supply and prices of medicines currently manufactured in India. It would also allay fears of developing countries about the continuity of supply of low-cost medicines from India." Still to look at However, all is not well. Like the NGOs, industry bodies such as the OPPI and IPA have some reservations over the Bill. Khorakiwala said, "There are still some 'lacunae' in the new Bill that needed 'correction', such as Indian residents not being allowed to file patents overseas without the approval of the Controller of Patents, the three-year cooling period which was not required under TRIPS. The Bill has also not withdrawn the option of early publication of patent applications." "Similarly OPPI has reservations on few issues. For instance, narrowing the definition of Patentability and broadening the scope of Compulsory Licensing will not be in our interests. As far as Patentability is concerned, India's strength lies in incremental innovation and we are not yet very proficient in discovery research, which is lengthy, risky and requires deep pockets. Hence the low hanging fruits of innovation such as NDDS (Novel Drug Delivery Systems), polymorphs, esters, isomers, etc. should have been grabbed with both hands. Compulsory Licensing is understandable for national emergencies but expanding the scope for commercial use will make mockery of the Patent Law. Also, granting pre-grant opposition will increase frivolous objections delaying the patent granting process. However, we are hopeful that over a period of time these issues could be resolved," said Dr Ajit Dangi. Organizations like Access to Medicine and Treatment Campaign (AMTC), Alternative Law Forum and Lawyers Collective, which have been raising voice against the Patent Bill, said in a press release that "now the real fight begins". "We will do everything to ensure that dubious patents are not granted by challenging them at all levels," said Leena Menghaney of the Lawyers Collective HIV/AIDS unit. "When legitimate patents are granted, we will ensure that when necessary we will push for compulsory licences with fair royalties that reflect industry norms." "The Patent Bill will severely curtail the ability of the developing countries to access affordable medicines," said Anand Grover, convenor of the Affordable Medicines and Treatment Campaign. Expressing similar views, Loon Gangte, president of the Delhi Network of People Living with HIV/AIDS said, "Today I am using generic AIDS drugs because I can afford the price. Since the Bill has passed, when I need new drugs, I won't be able to afford them. I could become one of the casualties of this new law." Reacting to these observations, Dr Ajit Dangi said that the public perception that product patents will have a negative impact on medicine prices is untrue, as 97 percent of the medicines in the WHO List of Essential Drugs are out of patent and will continue to be available at current prices. Also several therapeutic equivalents are available for patented drugs. These therapeutic equivalents are already out of patent. We also have the Drug Price Control Order (DPCO), which is monitored by National Pharmaceutical Pricing Authority (NPPA) to control medicine prices. The government should aggressively privatize health insurance so that patients will get reimbursed for medicine expenses as in most developed countries. The Doha Declaration also takes care of emergencies such as medicines for HIV/AIDS etc. By passing the Patents Bill, India has sent a message to the global community that the nation is open for business. Narayan Kulkarni   ]]> <![CDATA["IIT Kanpur focuses on interdisciplinary research in biotechnology" - Prof Pradip Sinha, head, BSBE]]> https://biospectrumindia.com/news/95/1751/iit-kanpur-focuses-on-interdisciplinary-research-in-biotechnology-prof-pradip-sinha-head-bsbe.html https://biospectrumindia.com/news/95/1751/iit-kanpur-focuses-on-interdisciplinary-research-in-biotechnology-prof-pradip-sinha-head-bsbe.html Mon, 11 Apr 2005 15:53:00 +0530 The new Biological Science and Bioengineering (BSBE) department in IIT Kanpur is the first facility of national importance that has been created with the MPLADS fund. In an exclusive chat, Prof Pradip Sinha, Head BSBE, shares his vision and future plans for the department. How was BSBE established? Arun Shourie pledged the entire sum of MPLADS (Member of Parliament Local Area sDevelopment Scheme) under the auspices of his membership in the Rajya Sabha (1999-2004) for a multidisciplinary initiative in Biology at the Indian Institute of Technology, Kanpur. Shourie was of the opinion that if the entire fund, to the tune of Rs 12 crore, supports a single cause then it would guarantee the success of the endeavor in all its dimensions. This pledge led to the creation of a new department of Biological Sciences and Bioengineering (BSBE) at IIT Kanpur on September 13, 2001. This was followed by recruitment of faculty, identification of areas of research, initiation of new academic programs and, finally, development of research infrastructure and facilities. What are the key focus areas of research and academic programs in the BSBE department? Research is currently going on in the department in the areas of developmental biology, human genetics, bioinformatics, genomics, structural biology, bioremediation, tissue engineering and biomaterials. The department has excellent facilities for cellular imaging techniques, cell and molecular biology, genomics, tissue engineering and computational biology. Major facilities/equipments include DNA sequencers, confocal microscope, atomic force microscope, fluorescence video microscope, Affymetrix microarray platform, peptide synthesizer, besides high performance computational facilities. The department offers two postgraduate academic programs-M Tech and PhD in Biological Sciences and Bioengineering. A new B Tech program has been introduced from the year 2004, which provides a unique fusion of biology with other basic science and engineering disciplines. The emphasis in all the academic programs is on the synthesis of modern biology, science and engineering. The idea is also to gain from the natural strength in the campus - namely chemistry, physics, computer sciences and engineering disciplines. What is your vision for the department? Our goal is to create a new brand of students who have the understanding of a wide gamut of engineering topics and are capable of blending these concepts and principles with biology. I am sure we will soon create a new generation of undergraduate and graduate students who are capable of meeting the demanding needs of both academia and industry in life sciences, biotechnology and biopharmaceuticals. The future vision of MPLADS at IIT Kanpur would thus come true through the intellectual leadership of these new generations of researchers and students, and from their ability to seize the opportunities available in the forefront of biological research. Rolly Dureha ]]> <![CDATA[M&A Mania]]> https://biospectrumindia.com/news/95/2476/ma-mania.html https://biospectrumindia.com/news/95/2476/ma-mania.html Mon, 11 Apr 2005 15:50:00 +0530 Ocimum to acquire German company's microarray assets Ocimum Biosolutions, provider of laboratory information management systems (LIMS), bioinformatics solutions and contract research, has announced to acquire core assets of Germany-based MWG Biotech AG's "Genomic Diagnosis" microarray business. The financial details were not disclosed. Ocimum will take over the microarray know-how, expertise and assets of the microarray business line, including inventory and stock. MWG Biotech's former "Genomic Diagnosis" employees are not part of the transaction. The new location of the microarray business will be in Hyderabad. Part of the services will also be offered from Indianapolis, US. Avesthagen acquires Good Earth Foods Bangalore-based Avesthagen announced the acquisition of Good Earth Foods Pvt Ltd, a health foods company specializing in breakfast cereals and biscuits. The new company promoting the products will be called Avesta Good Earth Foods Pvt Ltd and is a wholly owned subsidiary of Avesthagen. The acquisition is part of Avesthagen's long-term strategy to launch its branded nutraceuticals as functional foods targeting the burgeoning health foods market in India. The new line of business also complements the company's core philosophy of promoting good health and well being in India and abroad through their efforts. Actavis to acquire Lotus Labs Actavis Group announced the finalization of the agreement for acquisition of Lotus Laboratories , the Indian CRO company, for a cash consideration of around Euro 20 million. The acquisition was subject to satisfactory due diligence and finalization of share purchase agreement. These conditions have now been met and the final agreement for the acquisition has been signed. ]]> <![CDATA[IIT Delhi and FICCI organize symposium on biotechnology]]> https://biospectrumindia.com/news/95/2216/iit-delhi-and-ficci-organize-symposium-on-biotechnology.html https://biospectrumindia.com/news/95/2216/iit-delhi-and-ficci-organize-symposium-on-biotechnology.html Mon, 11 Apr 2005 15:49:00 +0530 A national symposium on Biochemical Engineering and Biotechnology -"Biohorizon-2005" was organized at IIT Delhi. The event focused on identifying opportunities for sustained industry-academia interaction and creating a scenario conducive to innovation. It also served as a platform for providing an insight into relevant cutting-edge research activities. Prof Saroj Mishra, head, Biochemical Engineering and Biotechnology, IIT Delhi addressing the inaugural session of BioHorizon 2005. The two-day event featured technical and business sessions. The business sessions saw panel discussions on IPR issues in biotechnology, opportunities in biotechnology careers; and a focus workshop on bioentrepreneurshipâ€“ bioventures. The objective of the symposium was to promote greater awareness and interaction amongst the young biotech community about the new and emerging areas in the field. The forum served as an opportunity for the new generation of biotechnologists to exchange their concepts, views, knowledge and ideas. Participants from over 250 institutions across the country participated in the event. The symposium was jointly organized by the Biochemical Engineers and Technologists Association (BETA) of the Indian Institute of Technology, Delhi (IIT-D) and the Federation of Indian Chambers of Commerce and Industry (FICCI). ]]> <![CDATA[India, UK further collaborations in science and innovation]]> https://biospectrumindia.com/news/95/1538/india-uk-further-collaborations-in-science-and-innovation.html https://biospectrumindia.com/news/95/1538/india-uk-further-collaborations-in-science-and-innovation.html Mon, 11 Apr 2005 15:47:00 +0530 The UK and India are planning to scale-up the breadth and depth of bilateral activities in the area of science and innovation. The establishment of an "Indo-UK Science & Innovation Council" is on the cards, which will focus on building the work of the existing Science and Technology Joint Committee. The decision to expand science cooperation follows a visit to India by the United Kingdom's chief scientific advisor, David King in early February. King met India's science minister Kapil Sibal and senior officials of key scientific departments. The Council is expected to be launched by April 2006 and will include CNR Rao, the scientific advisor to the Indian cabinet, David King, and senior science officials from both countries. There will also be a greater thrust on activities planned in the area of life sciences and biotechnology. "Both India and Britain are looking towards becoming knowledge-based economies. The UK science base is one of the strongest in the world and India has specialists in niche scientific areas where we could link up", said Sir Michael Arthur, the UK high commissioner in India. The two countries are exploring possible areas of collaboration on health issues, such as development of vaccines for HIV, tuberculosis and malaria, biotechnology, nanotechnology and stem cell research. ]]> <![CDATA[UP to set up Rs 50-crore VC fund]]> https://biospectrumindia.com/news/95/2703/up-to-set-up-rs-50-crore-vc-fund.html https://biospectrumindia.com/news/95/2703/up-to-set-up-rs-50-crore-vc-fund.html Mon, 11 Apr 2005 15:45:00 +0530 The UP state government has announced some incentives for the biotechnology industry. These include a Rs 50-crore Venture Capital Fund /Seed Capital Fund, which is being set up for the research-based industry; cent percent stamp duty exemption on biotechnology units; entry tax exemption for fifteen years on capital goods including captive generation sets; 15 percent subsidy on capital investments to the maximum limit of Rs 30 lakh shall be admissible to the new biotech units and the expansion of existing units. Announcing these incentives at the "Destination UPâ€“Biotechnology Opportunities" conference in Lucknow, Amar Singh, chairman, Uttar Pradesh Development Council, said that in this age, biotechnology is one of the most important growth engines not only for the state but also for the country at large. "If there is connectivity and intellect, there is nothing that can hold us back," he said highlighting the strengths of UP that would play a crucial role in the growth map of the state, especially in sectors like biotechnology and IT. Addressing the conference, Dr Joe Marwah, CEO, Biotechnology Consulting & Research Inc, California, pointed that all research conducted should have a commercial value. Dr Navneet Sahgal, secretary, Science & Technology, Government of UP, apprised the audience that the consensus of the meet was to set up an informal biotechnology group which will be headed by Dr V P Kamboj, former director, CDRI. The group will consist of directors of CDRI, ITRC, CIMAP, NBRI, CEO Biotech Park, CEO Biotech Development Board UP, SIDBI, SBI, Director-Horticulture, Director-Medical, Director-Agriculture and CII. ]]> <![CDATA[VH Group to launch FMD vaccines]]> https://biospectrumindia.com/news/95/2903/vh-group-to-launch-fmd-vaccines.html https://biospectrumindia.com/news/95/2903/vh-group-to-launch-fmd-vaccines.html Mon, 11 Apr 2005 15:44:00 +0530 Pune-based Venkateshwara Hatcheries (VH) Group is all set to launch a vaccine for Foot and Mouth Disease. The vaccine will be manufactured at BV Biologicals, a new entity of the VH group created at the Hinjewadi Biotech Park. About 40 percent of the vaccine will be exported. The company is investing more than Rs 30 crore acquiring state-of-the-art biotech tools to improve animal health care systems. Anuradha Desai, chairperson of VH Group, said that the new biotech plant will be commissioned in June this year. "We will continue to invest on advanced biotech tools for human health care and also sustainable medical healthcare-based products for use by the masses. We have always been producing vaccines to keep our poultry healthy. Now, we want to extend it to cattle because the raw material is the same," she explained. Desai said that the company is building new labs in 13 cities across the country in Haryana, Rajasthan, Punjab, Tamil Nadu, Maharashtra and Andhra Pradesh to facilitate disease surveillance. "The facilities will put in clean herd management practices in place, support the national animal food policy and open up international markets in animal produce," she added. OP Singh, VHPL vaccine and AHP division, confirmed that recent advances made globally were being tied up with the VH Group's R&D programs with a concrete product rollout plan, to ensure availability of affordable healthcare products for the masses. He also confirmed the company's business involvement on certain lead molecules to revolutionize current therapeutic segment of many major challenging diseases. - CyberMedia News ]]> <![CDATA[Rs 20 crore for biotech PPP fund]]> https://biospectrumindia.com/news/95/1794/rs-20-crore-for-biotech-ppp-fund.html https://biospectrumindia.com/news/95/1794/rs-20-crore-for-biotech-ppp-fund.html Mon, 11 Apr 2005 15:43:00 +0530 Stressing the need for having an effective Public Private Partnership (PPP), scientific advisor to Department of Biotechnology, Minister of Science and Technology, Dr SR Rao said that the Union finance minister has announced Rs 20 crore towards PPP fund for R&D in the field of biotechnology and Rs 150 crore towards the pharma fund. Dr SR Rao Speaking at a media workshop on "Public Private Partnership in Biotechnology", organized by the M S Swaminathan Research Foundation in Chennai, he said that the creation of offshore technology R&D labs outside India would allow the scientists to share the technology know-how in the field, besides encouraging the outsourcing of the R&D centers. Suggesting two future models for PPP in biotechnology â€“ alliance model and R&D service model, Dr Rao said that the R&D service model would work along with the universities, government, private and others for encouraging PPP in the field of biotechnology research. Speaking on the occasion, KK Narayanan of Metahelix, said that at least 50 percent of the government funded programs must have a commercial partner, who will be responsible for guiding the R&D program initiated by the government laboratories towards creating marketable products. "This will ensure that R&D at government laboratories meets the requirement of the national and global market," he observed. Further, he suggested setting up of at least five new PPP in every state, each year, and at least one of these five should lead to new product introductions from 2010. - CyberMedia News ]]> <![CDATA["We will consider an investment in the Rs 5-15 crore range" - Ajay Kumar Kapur, CEO, SIDBI Venture Capital Ltd]]> https://biospectrumindia.com/news/95/2909/we-will-consider-an-investment-in-the-rs-5-15-crore-range-ajay-kumar-kapur-ceo-sidbi-venture-capital-ltd.html https://biospectrumindia.com/news/95/2909/we-will-consider-an-investment-in-the-rs-5-15-crore-range-ajay-kumar-kapur-ceo-sidbi-venture-capital-ltd.html Mon, 11 Apr 2005 15:40:00 +0530 How different is the SME Growth Fund from SIDBI's NFSIT? The Small Industries Development Bank of India (SIDBI) has been disbursing funds through its branch offices across India. In 1999, SIDBI set up a first national venture fund called National Fund for Software and IT Industry (NFSIT). This was the first sector-specific fund with a corpus of Rs 100 crore set by SIDBI in association with IDBI and the Ministry of Communications and Information Technology. SIDBI accounted for 50 percent of the total contribution, IDBI for 30 percent and the rest coming from the Ministry. This was a 10-year fund and we have invested in 25 software, ITES and IT companies. In October 2004, we launched another fund called SME Growth Fund. It is general fund with focus on growing sectors such as life sciences, clinical research, biotechnology, retailing, light engineering, food processing, information technology, infrastructure-related services, healthcare, logistics and distribution, other than IT and software. The fund has a targeted corpus of Rs 500 crore with a life of eight years. SIBDI has committed Rs 100 crore while other banks have committed Rs 375 crore. The banks include State Bank of India and Punjab National Bank (Rs 100 crore each), Bank of Baroda and Oriental Bank of Commerce (Rs 50 crore each), Corporation Bank, Bank of India and Union Bank (Rs 25 crore each). We will be closing this fund within a month's time and announce the total amount that has been raised for the SME Growth Fund shortly. Have you earmarked funds for each of the sectors you noted for disbursement? No, we haven't earmarked any specific amount for each of the focus sectors. We would look at as many opportunities as possible to these different sectors under the Growth Fund. Allocation of funds for individual sectors has not been attempted so far. Some sectors like the biotechnology have longer gestation periods. Will such a sector get affected if you run out of funds? It doesn't happen that way, as the fund (Rs 500 crore) will normally be invested over the next three-four years. So we wouldn't see such a situation wherein we run out of the venture capital funds. If we are in such a scenario, then instead of making the investments over four years, we may end up with two years and may look at increasing the fund or look at coming out with another fund. There is that flexibility and we will look at all opportunities that come up for consideration. Or it also could be the other way round. What would be the average size of funding? Our definition of a SME is one whose net investment in plant and machinery does not exceed Rs 10 crore. Though the government has defined SSIs, it hasn't strictly defined a SME. Some of the international definitions for SMEs are based on employment and turnover. SIDBI has been considering SME as an industry where the net investment in plant and machinery is not more than Rs 10 crore in terms of depreciation. We are looking at making an investment in the range of Rs 5-15 crore. But we haven't specified the minimum range. Even smaller investments would be considered, if we look at follow-on investments to happen. We may consider investments that are lesser than Rs 20 crore for the biotech sector. Do you have any plans of funding R& D companies? Pure R&D outfits will not be funded, as the SME Growth Fund is basically a venture fund. The investors seek return on investments. In biotechnology, there will always be some component of R&D. But if it is purely R&D, it will have to be commercialized subsequently. This relates to an early/seed stage requirement. We are into growth stage and are not investing in seed/early stage companies. We expect the revenue model to be clear. However, we will also look at companies that are expanding from early to growth stage. Have you received any proposals from biotech companies? We are looking actively at the biotechnology sector and have got about five-six enquiries from this space and about three-four proposals are under consideration. We are also in discussion with APIDC Biotechnology Venture to pursue investment in this space. We look forward to invest in many biotechnology companies. ]]> <![CDATA["GVFL would invest in early start-up companies" - Vishnu Varshney, CEO, GVFL]]> https://biospectrumindia.com/news/95/2169/gvfl-would-invest-in-early-start-up-companies-vishnu-varshney-ceo-gvfl.html https://biospectrumindia.com/news/95/2169/gvfl-would-invest-in-early-start-up-companies-vishnu-varshney-ceo-gvfl.html Mon, 11 Apr 2005 15:30:00 +0530 Ahmedabad-based Gujarat Venture Finance (GVFL) Ltd announced the setting up of Rs 50-crore Gujarat Biotechnology Venture Fund (GVBF). The GVBF was launched during Vibrant Gujarat, 2005. This is a 12-year close-ended state biotech fund. The state government provided the initial seed funding of Rs 5 crore. GVFL Ltd will mobilize the remaining fund from institutional investors like SIDBI, UTI, banks, corporate entities and high net worth individual. Vishnu Varshney, CEO, GVFL Ltd, spells out GVFL's plans. How many biotechnology companies have so far approached GVFL and what is the status of the proposals? We have received five to six good proposals till date, which we are looking into. Though we keep receiving at least two or three proposals every week, most of them do not fit into our investment criteria. Is this fund reserved only for the companies based in Gujarat? The main operations of the company have to be based in Gujarat. The company may then have units outside Gujarat. What are the criteria considered for funding? The two things that we would be mainly looking for are technology and scalability. While the technology has to be innovative, the business has to be scalable. These are followed by other criteria like promoters' experience and exit option to GVFL. What is the maximum and minimum amount that GVFL will disburse to a company? We would be considering a maximum investment of Rs 5 crore in one company. As far as the bottom limit is concerned, anything below Rs 50 lakh would not be a fit to our investment portfolio. Don't you feel that the 12 years is too long a period for a Rs 50-crore fund? Do you intend to increase the size of the fund? GVFL's focus would be to invest in early start-up companies. If you look at the long gestation period of biotech companies, I do not think 12 years would be too long a period. Statistics show that it takes more than 10 years just to enter the Phase II trials in drug development. Depending upon the quality of proposals we receive, we may increase the size of the fund. What is the total funding requirement you foresee for the biotech sector in India? If you look at the figures, the Indian government in its tenth five-year plan (2002-07) has allocated Rs 1,800 crore for the biotech sector. Combine this with the number of VC-firms that have come up with biotech-focused funds. I am sure the figure would cross Rs 3,000 crore. What are the exit options before the VCs in the case of biotech investments? With a relatively long gestation period for a biotech start-up, Initial Public Offer (IPO) as an exit route looks a little far-off option. Also, SEBI regulations require meeting some minimum criteria before you can approach the market. In these scenarios, strategic tie-up and strategic sale seem to be the most viable options. What should the government do to support the biotech growth in India? We believe that the government has a much greater role to play in the growth of biotechnology in India. Besides developing a robust regulatory framework and setting up biotech parks, an incubation fund for the early entrepreneurs can be started to whet their technology and processes before these entrepreneurs can approach a VC for a larger fund. Narayan Kulkarni   ]]> <![CDATA[Bangalore gears up for its premier biotech show in April]]> https://biospectrumindia.com/news/95/2015/bangalore-gears-up-for-its-premier-biotech-show-in-april.html https://biospectrumindia.com/news/95/2015/bangalore-gears-up-for-its-premier-biotech-show-in-april.html Mon, 11 Apr 2005 15:21:00 +0530 The fifth edition of Bangalore Bio 2005, a premier annual biotech event, will be held from April 22-24, 2005 at the Palace Grounds, Bangalore. Bangalore Bio is India's biggest biotech show and is being promoted by the Government of Karnataka and the state's Vision Group on Biotechnology. The Vision Group is chaired by Dr Kiran Mazumdar-Shaw, chairman and managing director, Biocon. Bangalore Bio was first launched in 2001 and over the past four years, the event has emerged to be the largest congregation of global biotech community in India. Dr Anbumani Ramdoss, the union minister of health and family welfare, Government of India, will inaugurate the event on April 22, 2005. Shankaralinge Gowda, secretary, IT and BT, Government of Karnataka, informed, "Bangalore Bio 2005 will be a much bigger show with over 5,000 sq m of space for the tradeshow, international conference and a host of other events. We expect participation of about 100 companies from over 20 countries and 25,000 business visitors." Prominent Speakers Dr George Atkinson, scientific advisor to Secretary of State, USA Jairam Ramesh, national economic advisor, Government of India Dr Manuel Hallen, director general-research, European Commission Dr KV Balasubramaniam, managing director, Indian Immunologicals Dr Kiran Mazumdar-Shaw, CMD, Biocon Prof Sharat Chandra, director, Centre for Human Genetics Venkat Subramanium CMD, EXIM Bank Dr Byrappa Venkatesh, Institute for Molecular and Cellular Biology Singapore Dr Kalidas Shetty, associate professor, University of Massachusetts Sanjeev Chaudhary, area director, South Asia and country head India, Dupont Dr Shaji George, president, Biopharm Biologics Inc. Dr Indrani Karunasagar, UNESCO, MIRCEN Dr Villoo Morawala Patell, Avesthagen Vijay Chandru, chairman and CEO, Strand Genomics Dr D Balasubramanian, director, LV Prasad Eye Institute Dr Bhushan Patwardhan, consultant to WHO Geneva on traditional medicine Dr Uday Matrubutham, director, Invitrogen BioServices India Dr VP Kambhoj, former director, CDRI and chairman, BCIL The event will comprise a trade show, an international conference and special networking events like the CEO Conclave, Awards Nite and Bio Banquet. Mazumdar-Shaw said the focus of the three-day event would be on partnerships. While, the conference is expected to see about 60 speakers from across the globe sharing their outlook, a total of 700 delegates are anticipated to attend the conference. The inaugural ceremony of the conference will be addressed by Nobel Laureate Prof Dr Sydney Brenner, chairman, Biomedical Research Council, Singapore. With focal theme being "Bio-Partnering for Global Challenges", the conference will also include a round table on Biotech Policy and a panel discussion on Biotech Parks. The conference will have various tracks like Frontier Areas of Biotech Research, Clinical Research, New Trends in Agribiotech Research, Human Resource Development, BioEntrepreneurship, BioPartnering, Bioinformatics, Nutraceuticals, Marine and Animal Biotechnology and IPR & India. Gowda also informed that the state government is actively pursuing measures to foster the sector. Besides the biotech park, the government has initiated a proposal to set up a nodal agency for the bio-informatics sector, modeled on the lines of Software Technology Parks of India (STPI), in Bangalore. Another salient feature this year would be a focused session for the investor community, where the investors would be apprised about the various developments in the industry on regulations, markets, etc. "Last year, there was a tremendous response from the student community for the event. Thus, we thought that it was time to start a bio quiz to generate interest among the students towards biotechnology," Gowda said. Several companies, countries and states have confirmed their participations. Major players like Agilent Technologies, Alfa Laval, Astra Zeneca, Avesthagen, Biocon, JETRO, Jubiliant Biosys, Sami Labs, Sartorius and Strand Genomics will be participating in the tradeshow at Bangalore Bio 2005. Among the others, Invest UK, the state governments of Rajasthan and Chattisgarh have confirmed their representation. According to the organizers, delegations from Australia, Canada, Germany, Japan, Malaysia, Singapore and the UK will partake in Bangalore Bio 2005. ]]> <![CDATA[Wholesome BT Policy]]> https://biospectrumindia.com/news/95/2251/wholesome-bt-policy.html https://biospectrumindia.com/news/95/2251/wholesome-bt-policy.html Mon, 11 Apr 2005 15:20:00 +0530 Suresh N The long wait for the draft National Biotech Policy is finally over. From the contents unveiled on March 31, the wait seems alright. The task force headed by DBT secretary Dr M K Bhan has more or less included every major demand of the industry and has in fact drafted a very industry-friendly, forward looking policy document, titled, National Biotechnology Development Strategy. Clearly, the highlight of the proposal is the move to allow 100 percent foreign direct investment (FDI) in the form of equity in the biotech sector. It has not been spelt out explicitly. "As an effective regulatory mechanism has been put in place through recent interventions, Foreign Investment Promotion Board (FIPB) approval for equity investment may no longer be necessary," says the draft strategy. Another long-pending demand for a unified regulatory system for the sector is in the offing. The Mashelkar and Swaminathan task forces have made voluminous recommendations and Sibal has reiterated that these will be implemented. So the industry can look forward to a curtailed role of the much dreaded regulatory agency, GEAC and the biotech policy has put forward the proposal for an interim arrangement to oversee the regulatory system during the transition phase. The policy has called for appropriate government interventions to ensure that biotechnology too gets the tag "priority sector" for lending funds for long gestation projects by banks. Another innovative step is the move to set up a "Small Business Innovation Research Initiative" to provide grants and loans to small companies to support pre-proof of concept, early stage innovative research and provide mentorship and problem solving. This, if implemented properly, should help spark the entrepreneurship spirit and lead to the entry of many more Vijay Chandrus and Krishna Ellas into the sector. The proposal to set up a Biotechnology Parks Society of India (BPSI) on the lines of the successful STPI in software to promote a series of biotech parks by 2010 will be widely welcomed. STPI has been an amazing government agency which hand held the software sector to its dizzying heights. BPSI should emulate STPI and recreate the wonder in biotech without fail. A whole set of fiscal concessions will be available to these parks which will be treated as Special Economic Zone for preferential policy treatment. Almost all the major demands of various sub-sectors of the industry have been addressed by the policy. While the pharma, diagnostics and other key sectors have come out smiling, the bioagri segment may not be very pleased with the strategies announced in the document. The government has sidestepped the demand for the articulation of its policy on transgenic food items. "Transgenic plants should not be commercialized in crops/commodities where our international trade may be affected. However, their use may be allowed for generation of proof of principle, strictly for R&D, their alternate systems are not available or suitable," says the draft. This is a dampener and it is evident that the views of the strong NGO movement and basmati exporters have prevailed in the attempt to keep transgenics out of heavily traded commodities like rice and sugar etc for the fear of offending anti-GM countries. Of course, this has helped to provide a rare clarity about transgenic food crops and GM supporters will have to redouble their efforts to be heard. Overall, it is a wholesome strategy to stimulate the growth of Indian biotech over the next 10 years. <sureshn@cybermedia.co.in> ]]> <![CDATA["Lotus Labs' acquisition has set a benchmark for valuations in this industry," - Sudhir Pai, managing director, Lotus Labs Pvt Ltd]]> https://biospectrumindia.com/news/95/7566/lotus-labs-acquisition-has-set-a-benchmark-for-valuations-in-this-industry-sudhir-pai-managing-director-lotus-labs-pvt-ltd.html https://biospectrumindia.com/news/95/7566/lotus-labs-acquisition-has-set-a-benchmark-for-valuations-in-this-industry-sudhir-pai-managing-director-lotus-labs-pvt-ltd.html Fri, 08 Apr 2005 16:29:00 +0530 Is the acquisition complete and what were the transaction terms? Lotus was acquired by Actavis, a large pharmaceutical company headquartered in Iceland with operations in the US and Europe. As of March 18, 2005, Lotus is a wholly owned subsidiary of Actavis. What will be the positioning and strategy post the acquisition? Even though the ownership of Lotus has changed as a result of the acquisition, the management continues to be the same. Although new members have been inducted into the Board of Lotus, the whole time directors of Lotus-Dr Kishore Nayak, and I-will continue to run the operations of the company along with all the other senior employees of the company. The strategy post acquisition is to leverage the techno-commercial strengths of Actavis. Actavis has a large pool of technical talent, which will compliment the capabilities at Lotus. It will help us to have a better understanding of the regulatory affairs and the markets in the US and Europe. This will help Lotus gain better access to the regulated markets. How is the acquisition going to help Lotus? This acquisition will put Lotus on the global map. More overseas business will come in, which means better value per project, which will boost both our topline and bottom line. Lotus will be very well represented in Europe and the US since Actavis has operations already in the regulated markets. Will this set the trend for further acquisitions? This is the first transaction in the country in the CRO industry. We feel this transaction has set a benchmark for valuations in this industry. There are many companies in the US and Europe looking at setting up base in India and acquisitions and collaborations are the best and least time consuming way of doing it. We are certain that a trend has been set for many more such deals to happen. Are you going public? As of now there are no such plans. It is for Actavis group to decide the future course of action. Why was Lotus started in Bangalore? Pharmaceutical industry is concentrated in Mumbai, Hyderabad and Ahmedabad with all major companies located in those places except for one, which is situated in New Delhi. It is probably the reason why these three places get prominence as a CRO base as well. Bangalore is the knowledge base of India. Connectivity, climate, infrastructure and government support probably prompted CROs to base their operations out of Bangalore. Lotus was started in Bangalore since all the promoters are from Bangalore. What is the current status of the Indian CRO industry? The clinical trials industry is still nascent in India even though many hospitals are conducting Phase III trials for a number of years. Many hospitals are not conversant with GCP and often pose problems for sponsors since monitoring GCP compliance in large trials is a Herculean task. There are not many CROs equipped to conduct Phase I trials in India. Infrastructure, skill sets, comfort levels of companies with CROs, congenial regulatory atmosphere are far from being satisfactory. What are the key disease areas that you are focusing on? We are conducting clinical trials in the areas of oncology, cardiovascular, endocrinology, vaccines and neurology. Is there a gap between the supply and demand of trained personnel? There is a huge demand-supply gap at the moment in terms of trained/experienced personnel for conducting clinical trials. The industry itself being new, I feel that over a period of time more number of hospitals/professionals will join the clinical trials bandwagon. There are also some institutions considering clinical trials as part of their curriculum, which will help churn out more and more clinical trial/ research personnel in the years to come. What are the issues that are coming in the way of sponsors outsourcing their work to CROs? We feel that every company goes through a gestation period. It is in this initial stage that a CRO has to prove its capabilities to the sponsor and once the confidence-building is over, business will automatically follow. We are a four-year-old company and have to our credit more than 500 trials in the bioequivalence area. These studies have been submitted to regulated markets as well. Our Phase I unit commenced operations in the month of June 2004 and we are awaiting regulatory approvals to start trials which should happen any time from now. Our foray into Phase III trials happened in 2003 end and we have successfully completed eight clinical trials. Like every company, we have now proved to the sponsors that we are capable of handling clinical trials. We are confident that more and more business will follow. How many projects have you completed? We have conducted more than 500 studies in the bioequivalence area. This includes Fasting studies, Fed Studies, Food Effect Studies, Steady state studies, Drug -Drug interaction studies, studies on IV formulations, studies on patients etc. We have completed eight Phase III trials and undertaken activities starting from protocol preparation, CRF preparation, regulatory permissions, site selection, investigator selection, site initiation, site monitoring, obtaining ethics committee approvals, import of test medication etc. Namratha Jagtap and Ch. Srinivas Rao ]]> <![CDATA["India has enough manpower for CROs" -Bharat Doshi, Country Manager, Kendle India]]> https://biospectrumindia.com/news/95/2784/india-has-enough-manpower-for-cros-bharat-doshi-country-manager-kendle-india.html https://biospectrumindia.com/news/95/2784/india-has-enough-manpower-for-cros-bharat-doshi-country-manager-kendle-india.html Fri, 08 Apr 2005 16:16:00 +0530 Why are most of the CROs are based in Bangalore, Hyderabad, Mumbai and Ahmedabad? The CRO industry initially seeded itself in Mumbai and Ahmedabad and then expanded to Bangalore. Mumbai has been the trade capital and the hub for pharma companies since years, where as Bangalore became known as IT hub and hence the concentration of CROs in these regions. To add to this, the biotech industry also started in the southern region and gained momentum there. Moreover, the region boasts of a robust health care facility, which is essential for this sector. However, this essential element for a CRO industry i.e. clinical material is available throughout our country because of widely spread healthcare facilities, serving a huge patient population. Thus, the CROs will spread to other regions as well. One major factor for growth of this industry in India is a very good patientâ€“doctor relationship. This relationship in India is traditionally built upon virtues like trust, honesty, rights of confidentiality and rights as an individual. Communities of Indian doctors traditionally believe in values and ethics, which are now considered as pillars of ICH-GCP. This combined with advances in medical education and training will be the driving factor and the essential fuel for the Indian CROs to develop further. Many Indian sponsors are looking at outsourcing clinical trial (Phase I) to MNCs outside India. What could be the reason for this trend? Many of the Indian sponsors do have their in-house clinical research and trial set-up to which they entrust the work. This is understandable when the volumes are small. In many cases, Indian companies, which are planning to take approval from the foreign regulatory agencies like the USFDA, prefer getting their phase I trials and especially the bioequivalence and the bioavailability studies, done in that country. With Indian sponsors getting involved more and more in R&D, the volume of clinical research activities are going to increase and it will become mutually beneficial for Indian sponsors as well as CROs to harness efficiency by outsourcing to Indian CROs. What are the advantages that an Indian CRO can offer in the global scenario? Presently only the low cost of patient management is perceived as an advantage. But over a period of time, when India establishes its credibility in this sector and the Indian CROs have built the "Indian brand" in international clinical research, then the speed at which patients are enrolled, trials are completed, will become the primary attraction in global scenario. Are there sufficient trained people to carry out clinical trials/research in India? I do not believe that there is a huge lack of trained people as was seen in the IT sector during its boom time. India has enough manpower with the basic qualifications like a degree in pharmacy, medical or para-medical education or in life sciences. What is additionally needed is training or hands-on experience in this sector for about six months to a year to familiarize with the ICH-GCP norms. Practice-based training is very important and only theoretical knowledge is not enough. One can comply with the most stringent standards of GCP if he/she believes in these principles. One can believe in these principles if one experiences them in practice. If institutes offering courses provide practice-based education and exposure, then they can be an excellent training ground for students. What are the factors that an MNC looks at before outsourcing to CROs? The CRO industry is a new, sensitive and a serious field. Indian companies having the experience of working on international studies have an advantage in the global scenario. The foreign companies prefer to outsource their studies to CROs, which have worked on international projects, where the studies were conducted in adherence to international rules and guidelines and where the data had been submitted to international authorities. Thus concentration of experience is of utmost importance in making this decision. Rolly Dureha ]]> <![CDATA["There exists a big training gap between demand and supply" - Dr Arun Bhatt, president, ClinInvent Research Pvt Ltd]]> https://biospectrumindia.com/news/95/2774/there-exists-a-big-training-gap-between-demand-and-supply-dr-arun-bhatt-president-clininvent-research-pvt-ltd.html https://biospectrumindia.com/news/95/2774/there-exists-a-big-training-gap-between-demand-and-supply-dr-arun-bhatt-president-clininvent-research-pvt-ltd.html Fri, 08 Apr 2005 16:08:00 +0530 Why do CROs prefer Bangalore, Hyderabad, Mumbai and Ahmedabad? The main reasons seem to be the support of local pharmaceutical industry, availability of manpower and infrastructure and early establishment of bioequivalence CROs at these locations. Why are several Indian sponsors outsourcing clinical trial (Phase I) to MNCs outside India? The strategy of local companies is to license out the new molecule to an international company. The international company would expect the Phase I to be compliant with global regulations, GCP guidelines and scientific requirements. Besides, Phase I studies require excellent technical infrastructure for monitoring safety e.g., advanced cardiac/CNS instruments and bioanalytical support for estimation of new chemical entities. At present, India does not have adequate expertise and infrastructure for Phase I studies of global standards. In addition, compared to the West, our regulatory approval is slow for Phase I trials. Which are the key disease areas that Indian CROs are focusing on? Oncology, CVS, diabetes, CNS and psychiatry Is there a shortage of trained people in India to carry out clinical trials and research? Clinical trial management requires diverse skills â€“ project management, communication, presentation, writing, interpersonal, time management, finance management etc and good knowledge of clinical research therapeutic areas, statistics, pharmaco-vigilance, regulatory and ethical guidelines, GCP etc. These are not covered in the curriculum. Hence, there is a big training gap between demand and supply. What are the issues that confront a sponsor outsourcing its work to Indian CROs? The sponsor-CRO relationship requires the commitment of the top management of both sides. Besides, most Indian sponsors consider CRO activities as an additional expense and not an expert support. In addition, the sponsors are concerned that many Indian CROs lack trained and experienced manpower. At ClinInvent, we have focused on quality and training and hence, we have a large team of trained and experienced clinical trial professionals. We have already gained the confidence of sponsors and are currently running several global clinical trial projects. What is your expectation from the institutes offering courses on clinical research and data management? The institutes need to have experienced faculty, which can provide uniform education and requisite skills to students. Students should be made to realize the critical importance of their role in clinical trials and also should be prepared to face the interviews. Narayan Kulkarni ]]> <![CDATA[Overcoming challenges ...]]> https://biospectrumindia.com/news/95/1242/overcoming-challenges-.html https://biospectrumindia.com/news/95/1242/overcoming-challenges-.html Fri, 08 Apr 2005 16:05:00 +0530 Clinical research is losing its attractiveness in the US due to the shortage of investigators. By 2005, there will not be enough clinical investigators to handle the number of drugs in clinical development. CenterWatch estimates that against a 2005 demand for 56,000 investigators, only 48,000 will be available, a shortfall of 15 percent. On the other hand, India is moving closer to sponsors. It is mainly due to advantages it has. In contrast to this India too faces the dearth of investigators. According to industry sources, the country has about 500 investigators. If we go by the statistics, India has over 572,000 doctors, 43,322 hospitals and dispensaries and about 8.7 lakh beds including both private and public (2000). Majority of the doctors are graduates with little or no knowledge about clinical trials and hence would not qualify as investigators for complex international clinical trials. The issue here is that most of the medical professionals/specialists are not looking at investigation as a career option. They have their own reasons like time pressure, ethical and scientific complexity of GCP trials and lack of interest to take part in clinical trials. The situation requires tremendous efforts to attract the medical professionals/specialists to clinical research. Identifying and attracting potential investigators is the biggest challenge, requiring innovative approaches. The current efforts at training are fragmented. The training focus of sponsors and CROs is on the investigators involved in their trials and their own monitors and other professionals. As a result, a small number of trained investigators are retrained and large numbers of untrained physicians remain unexposed to research training. The enormous challenge of large number of quality professionals in medical and clinical research can only be met by cooperative and collaborative efforts between industry, academia and government. Besides the manpower efforts, the training activity will need financial support. In the US, the industry spends over $300 million on training. The funding has to come from all stakeholders, with majority share coming from the major beneficiary, the pharma industry. The National Institute of Health has established more than 80 General Clinical Research Centers (GCRCs) across the US. In 2002, these centers supported 11,000 clinical scientists who pursued more than 7,400 studies. In India we don't have such centers. At present there are two institutes offering courses related to clinical research and data management. One is the Academia of Clinical Excellence (ACE) and the other one is the Institute of Clinical Research India (ICRI). ACE was set up in October 2002 at the Bombay College of Pharmacy through the initiative and financial contribution of Pfizer India Ltd. It is expected that Pfizer will be contributing to the tune of $100,000 for a period of five years for the development of the academy. Subsequently, the academy was opened up for industry collaboration and Suven Life Sciences Ltd of Hyderabad has become a partner of ACE by making a financial contribution. The academy is conceived, as a one-stop-shop for all training needs of all clinical research professionals in the country. The ICRI commenced its operation in 2004 with its campuses located at Dehradun in Uttaranchal and in Mumbai. At present, training programs in clinical research are an occasional one-day or a two-day workshop planned by CROs and academia. To overcome the dearth of skilled people, Dr Arun Bhatt, President, ClinInvent Research Pvt Ltd suggested a new model that will generate 10,000 professional in a year. "We need to develop a new model along the lines of training provided for industry sales persons. We have the experience of conducting successfully a one-day basic GCP training module for 50 participants. Based on this experience, we feel that such a module can be expanded to a five-day (50 hours) orientation course covering core knowledge of clinical research and relevant management skills. A team of 10 full time trainers, with expertise in diverse disciplines, can manage such a course for 50 participants. Such a course, if run every week, will cover over 2,500 professionals in one year. By preparing five such teams located in different cities, we can train over 10,000 professionals in just one year. Of course, the faculty should be full time, drawn from senior retired professionals from industry/academia, many of whom are willing to devote their time to such activities. Besides, there are professionals in industry/CRO, who are keen to have a full time career in training," said Dr Arun Bhatt. If this model works out well with funding from public and private sector then crossing $1 billion mark will soon become a reality. Narayan Kulkarni ]]> <![CDATA[Info-GCP a platform for Indian CROs]]> https://biospectrumindia.com/news/95/2880/info-gcp-a-platform-for-indian-cros.html https://biospectrumindia.com/news/95/2880/info-gcp-a-platform-for-indian-cros.html Fri, 08 Apr 2005 16:01:00 +0530 There are few areas of science that cross as many boundaries as does clinical research. "Therefore, expanding clinical research cannot succeed without the wholehearted support of academia, industry, regulators and civil society. It is vital to develop robust mechanisms for co-operation between these stakeholders," pointed out Dr Dhananjay Bakhle, head of Medical Research & Regulatory Affairs, Sanofi-aventis. The India Forum for GCP (Info-GCP) was launched recently. Info-GCP would take a lead to develop such linkages to facilitate growth of clinical research in India. The main objectives of this new initiative include: Facilitating a discussion of ethical and GCP related issues. Offer a platform to update guidelines and working practices for the purpose of improving clinical research standards. Create and spread awareness of ethical principles in research and promote efforts towards its integration in GCP while conducting such research. Stimulate a closer relationship and improve understanding between key stakeholders of clinical research field, and also individual members of the Forum while sharing best practices. Foster the development of clinical research professionals through various means including training and continuing education programs in biomedical research and related areas, promote the development of Indian guidelines/directives based on these discussions and interactions, and share updates on new legislations/guidelines to key stakeholders in clinical research. Provide a national platform for all key stakeholders in clinical research by dealing with matters brought to its attention by the members. Why is it important? In 1996, the American Medical Association convened a major conference. The focus was on addressing the future of clinical research in the changing environment. The recommendation was to organize a national summit of key stakeholders in the domain of clinical research and as a result in 1998 a Clinical Research Summit was held at Graylyn, USA. More than 175 representatives from key government agencies, the pharmaceutical industry, major purchasers of health care, health plans and insurance companies, patient and family advocates, ethicists, the broad research community, and leaders of academic health centers made it to the summit that identified some problems that confront the clinical research enterprises and also developed a set of goals that were fully described in the Report of the Graylyn Consensus Development Conference (1998). The summit's final report, "Clinical Research: A National Call to Action (USA-November 1999)", identified the core problems and made recommendations to solve these problems. Nine core problem areas were identified. These being: lack of clear definition of clinical research; clinical research not being adequately understood or valued; lack of data on clinical research funding and productivity; insufficient funding for the conduct of some types of clinical research; insufficient numbers of clinical investigators; insufficient emphasis on incorporating research findings into clinical practice; inadequate coordination of clinical research among research entities and disciplines; and lack of comprehensive, dynamic and clinical research agenda. These core problems are not only relevant to the US but also to India, where clinical research is just making its entry. The Indian CROs have been facing these problems for some time but till now there have been no solutions in sight. To tackle the problem of not adequately understanding or valuing clinical research, the summit has made the following recommendations: â€¢ The ethical foundations of clinical research must be reinforced. â€¢ Federal protections (or their equivalent) for human research subjects should be applied irrespective of funding or venue. â€¢ Training for health professionals in the ethical framework of clinical research should be expanded. â€¢ Public understanding of clinical research and confidence in clinical research ethics must be strengthened through dialogue that promotes mutual understanding â€¢ The research community should develop separate and coordinated strategies to enhance public understanding of clinical research. â€¢ Last but not least, all entities involved in clinical research should seek out means to restore trust between the scientific community and populations that have been subject to questionable or unethical research practices. Similarly for lack of data on clinical research funding and productivity, the summit's recommendations include: â€¢ Mechanisms to track and disseminate the aggregate levels of financial support for clinical research provided by public fundings, industry, foundations, voluntary organizations, health plans and insurers, academic health centers, hospitals, and other health care providers. â€¢ A national strategy should be developed for a public-private sector partnership to fund the creation of broad-based clinical information systems. â€¢ A substantial investment is needed to meet the requirements of health services and population-based research and the advancement of evidence based medicine. On the issue related to insufficient numbers of clinical investigators, the summit made the following recommendations. â€¢ A process should be established to monitor and promote clinical research career development across the health professions, in order to meet the needs and promote the different categories of clinical research and foster the development of a cadre of well-trained clinical investigators across all health disciplines. â€¢ An ongoing high-profile forum should be initiated to discuss strategies that could include: recruiting more trainees from underrepresented communities, building upon promising training models developed at academic health centers and the NIH and evaluating new clinical research development awards at NIH. A visible, credible, and broadly representative entity should be established to focus on continuing needs, priorities, and future progress of clinical research. This, the summit noted, would help to overcome the problem of a lack of comprehensive, dynamic, clinical research agenda. To overcome the problem of ability of academic health centers to conduct clinical research, which is at risk, the summit suggested to support and strengthen the training required for investigators. In addition to this, the summit maintained that support for efforts by industry and the NIH should be furnished to develop mixed academic/non-academic clinical trials sites. Incentives should be provided to managed-care organizations and other providers to participate directly in clinical research. Practice networks and managed-care organizations should expand their clinical trials capabilities, as well as their health services, prevention, and epidemiological research. These measures will try to bring down the insufficient emphasis on incorporating research findings into clinical practice. Other models For re-building clinical research program in the country of origin, one of the models that can be looked into is the British Model. It is Public-Charity-Academia partnership program. In 1997, the Wellcome Trust funded £20 million through Millennia Award Scheme to develop clinical research facilities at Birmingham, Cambridge, Edinburgh, Manchester and Southampton. Besides grants were also awarded to universities and trusts for infrastructure and the facilities run by National Health Service (NHS) from their R&D budgets. In addition to this, to strengthen the clinical research infrastructure in the UK, it has proposed a virtual national network for clinical research funded by Department of Health and managed through a Special Health Authority. The European Parliament and Council have formed European & Developing Countries Clinical Trials Partnership (EDTCP) in response to the combined political will and health priorities of both the developing and developed world. Its objective was to contribute to the development of new and affordable therapeutics and prophylactics for HIV/AIDS, tuberculosis and malaria. Initially, EDTCP will focus on the countries most severely afflicted, primarily Sub-Saharan Africa. The EDCTP comprises 14 EU member states plus Norway and is funded by the European Union to promote a more integrated approach to health research amongst European countries. At present, the EDCTP operates on a European Commission contribution of Euro 400 million distributed over five years. The EDCTP is about partnership, pursuing a common platform to optimise synergies. It is also forming strategic alliances with like-minded organizations in the public and private sector towards achieving common goals. It is poised to provide a platform for the conduct of large-scale clinical trials and the development of the required capacities in developing countries. Furthermore, it aims at improving synergies of, and collaboration amongst, national and international research programs. Looking at these two initiatives, India still does not have one such forum. India has a good government medical infrastructure. But it is not sufficient to the growing population of India that has already crossed over a billion. The government hospitals were made for certain capability but are overused. This is what the union minister of state for tourism, Renuka Choudhary, who is keen on developing India as a destination for medical tourism, noted. The government needs some support from the private sector to develop the medical infrastructure so that more clinical trials could be carried out from these government hospitals. The Info-GCP forum certainly can work not only for the industry but also act as a catalyst to build trust with the patients and changing public perceptions about clinical trials, which is the need of the hour. A beginning has been made. Narayan Kulkarni ]]> <![CDATA[GM Crops and Biodiversity: What's The Fuss All About?]]> https://biospectrumindia.com/news/95/7545/gm-crops-and-biodiversity-whats-the-fuss-all-about.html https://biospectrumindia.com/news/95/7545/gm-crops-and-biodiversity-whats-the-fuss-all-about.html Fri, 08 Apr 2005 15:58:00 +0530 Anti-GM crop activists are of the strong belief that GM crops pose a threat to biodiversity but this is far from truth and is yet to be proven scientifically. Shanthu Shantharam Biologistics International, Ellicott City, MD, USA sshantharam@biologistics.us There is an urban myth bandied around by many critics of biotechnology that GM crops are a threat to natural biodiversity. If you utter GMOs and biodiversity in the same breath, many opponents of GM crops get all worked up about a doomsday scenario where in the biodiversity (as however we understand it) will be "contaminated" or "polluted" or "destroyed" beyond redemption by the flow of GM genes. For that reason alone, they argue that the introduction of GM crops in the centers of origin and diversity must not be allowed. It is nobody's case that that biodiversity is not under threat around the world, and all steps must be taken to prevent further erosion of biodiversity. There are ever so many national and international efforts under the aegis of Convention on Biological Diversity (CBD) to just do that. In fact, millions of dollars are being spent on a global scale to tackle the problem. The DIVERSITAS program is one of the outstanding global research programs on protecting tropical biodiversity with the help of some of the best qualified scientific professionals. Still, whatever efforts that is under is not enough to cope with the speed of biodiversity erosion. There is no question more must be done to conserve biodiversity, and what it takes are strong political will and resources. The allegation that modern day GM crops will negatively impact biodiversity has no scientific basis. It is charged that GM crops will reduce on-farm diversity. Some even suggest that those valuable and delicate land races will be lost forever due to GM crops. When the first report of a technology to control gene expression later dubbed the "terminator" technology to a devastating effect came along, some leading lights of Indian agriculture at the time scared the public by suggesting that these "terminator" genes would escape from GM crops and render the country's biodiversity sterile. Most never understood the basic mechanism of the "terminator" technology then and most don't understand it even now. But, all and sundry who had to have a say in the matter did not hesitate to invoke the "dangers" of terminator technology and do so even now just to keep the pot stirred. To date there is not a single GM crop that is endowed with the so-called "terminator" growing genes anywhere in the world. The issue has been politicized so much that the industry was compelled to pledge not to deploy the technology. Many still pander the fear that the commercialized Bt cotton contains the "terminator" genes and some implicitly believe that GM seeds mean they necessarily contain the deadly "terminator" genes. Activism against GMOs is so dishonest and disingenuous that truth and facts do not seem to matter. What matters is to just keep scaring the gullible, the innocent and the ignorant to keep the activism alive. The media promptly reports these propaganda and scientists who should and do know better do precious little to challenge this mischievous propaganda. Lies repeated thousand times become the truth. Most people who rave and rant about biodiversity have very little understanding of what it is. For most, it is just a romantic notion (feel good factor!), and for many it is a tool for political activism, and for a few it serves to rake in grants. It is only those who work in the field of bio-prospecting and enumerating living organisms (taxonomists and ecologists) have some clues to what biodiversity means and how complicated it is and what its real worth is. The general public is completely clueless about biodiversity. The gullible public is taken for ride on biodiversity by activists and sloganeers. Biodiversity is a complex entity. Only a fraction of natural biodiversity is really known. It is really uncertain if we will ever fully understand and characterize biodiversity. That is a dream of scientists. There are as many definitions of biodiversity as there are experts, and suffice it to say that biodiversity is what is in the eyes of the beholder. Biodiversity is a dynamic mix of all living species with their genes and genomes interacting with the environment and each other and in a state of constant flux. At the lowest level, it is made up of nucleic acids, proteins, lipids, and carbohydrate sequences that give them a form, structure and function. Distinction must be made between on-farm diversity and natural (wild) biodiversity as on-farm biodiversity is still an artificial construct. Biodiversity is also highly resilient and quite a few endangered and threatened species have been restored both by human intervention using modern scientific approaches and natural process. Biotechnologically is eminently suited to play a significant role in conserving and restoring biodiversity and can also aid in sustainable (non-destructive) utilization of biodiversity. But how true is that GM crops really present a threat to biodiversity? After all, every one of us should value biodiversity as it is the basis of life as we know it and it would be foolhardy to design ways and means to destroy whatever is left of it. There is no question that ever since humans started to dominate the earth and improve their living, they started using (exploiting) natural resources and most important of them being plants and animals around them. But, the scale and range of exploitation has increased with time (due population growth) and this is now known as destruction of the habitat. By an expert reckoning, destruction of habitats is the number one cause of loss of biodiversity. The second important reason is due to introduction of alien and invasive species (again a part of human activity) through travel, trade and commerce through the ages. Agricultural tillage, intensive use of chemicals and fertilizers are linked to decline of on-farm biodiversity and agri-ecosystems. It was just reconfirmed by a Royal Society publication on a three-year field scale evaluation of HR GM crops in UK over three years. This deliberate destruction has done some enormous good and done some very bad things to our environment. Overall, it has benefited the humanity in terms improving the living standards, food supply and health care. Some may not agree with this view, and perhaps for some good reasons. It is a question of value judgment! But, there is no way we would come to enjoy today's living standards without such utilization (exploitation) of natural resources. Most agree that our planet's environment is degrading due to human activities. There is no doubt that global warming is not helping the situation. Agriculture happens to be one of the oldest of human activities that has caused considerable habitat destruction to convert natural landscape into arable land. To improve agricultural productivity, people started selecting crops and animals which they deemed most desirable and started improving them through breeding and now through biotechnology. As the productivity increased, the population increased and that fed into the cycle of producing more and more. That cycle broke down intermittently due to natural calamities like drought and famine. The net result was increasing the arable land, selecting a few dozen staple crops and animals and breeding them to be more and more productive (reduction of on-farm biodiversity). One thing is for certain that new and improved crops have always replaced old and inefficient varieties in succession. For example, Bt cotton in India is poised to replace non Bt cotton within the next few years just for the simple reason that it is economically beneficial. With hind sight, we can see how some aspects of green revolution technologies have caused environmental degradation, and that should be instructive for all of us to learn from those experiences and see how we don't repeat those mistakes with new technologies like biotechnology. To the extent we ask such pertinent questions as we do during biosafety and environmental impact assessments of GM crops the potential impact of GM crops on biodiversity is addressed with the best possible knowledge and information and data then, we should be able to take proper precaution to deploy new technologies safely. In modern agriculture, we certainly produced more food and at the same time caused some unavoidable environmental degradation. In fact, agriculture is known to be one of the most environmentally destructive of human activities. But, the question is did we have a choice? We need to produce sufficient food for all and modern intensive cultivation methods became that choice. According to many, there were other choices, and still there are many (alternatives like organic farming, SRI and diversified agriculture) only if the stranglehold on the agricultural by the industry is pried off, and return to natural way of growing food. Many experts engaged in food production disagree. Just last week the venerable Norman Borlaug said as much in India. There is not sufficient organic matter to produce enough food for all on this planet and chemicals will and must be the mainstay of modern agriculture. Debates are raging all over the world, and suffice it to say any agreement on these issues is still long ways in coming. (To be continued) ]]> <![CDATA[Industry calls for effective biotech policies in Europe]]> https://biospectrumindia.com/news/95/1274/industry-calls-for-effective-biotech-policies-in-europe.html https://biospectrumindia.com/news/95/1274/industry-calls-for-effective-biotech-policies-in-europe.html Fri, 08 Apr 2005 15:57:00 +0530 The biotechnology industry bodies like France Biotech, the French Biotechnology Industry Association, EuropaBio, The European Association of Bioindustries have called for the need to pursue ambitious actions to develop real and effective biotechnology industrial policies that should integrate research, development, and biomanufacturing. With 190 medicines and vaccines already available and more than 400 therapeutic products under development in 2004, biotechnologies are targeting over 300 million patients in the world. These medicines are offering safer, more efficient medicines with reduced side effects, and new therapeutic strategies for very incapacitating illnesses, which have gone untreated until the arrival of biotechnology. Small and medium-sized biotechnology companies and researchers are working to renew the portfolios of therapeutic products available to doctors and patients by undertaking cutting-edge research and using the very latest healthcare technologies. Thus it is crucial to stimulate the environment for these young innovative biotechnology companies and tighten their collaboration with academic research and the pharmaceutical industry where both the know-how and capacity lie to develop and commercialize their products. The components of an efficient national and European policy in life sciences are well identified and it is now time for the European governments and various authorities to act by taking into account the industry's recommendations. Source: www.europabio.org BIA welcomes publication on pre-emption guidelines The BioIndustry Association (BIA) has welcomed the publication of the report by Paul Myners on pre-emption. The report reviews whether the current pre-emption guidelines in the UK inhibit the ability of certain public companies, including bioscience companies, to raise finance from the capital markets. It concludes that the current blanket approach to disapplying pre-emption rights is not working as intended due to a rigid interpretation of the existing guidelines. The report recommends that the current guidelines should be replaced with new guidance emphasising a case-by-case engagement between a company's directors and shareholders. Myners further recommends the formation of a new pre-emption group with wider membership to take a more proactive approach to monitoring the application of such guidance. "This is excellent news both for the UK bioscience companies and for the future of the bioscience industry in this country. It is extremely positive that this important report has confirmed that there is an issue with the current pre-emption guidelines for UK bioscience companies. It affects their ability to raise finance from the capital markets and thus their ability to progress the development of their businesses," said Aisling Burnand, chief executive of the BIA. Paul Myners has concluded in his report that the principle of pre-emption rights is a valuable one, which should be upheld. "The BIA absolutely endorses that: shareholders own the company and the BIA strongly supports the principles of promoting and protecting shareholder value," Burnand added. The report also highlights other issues affecting the bioscience-funding environment. The BIA will be working with all stakeholders to look into further details. Source: www.bioindustry.org Dr Lester Crawford may become next FDA Commissioner Dr Lester Crawford is likely to become the next FDA Commissioner as the US President George Bush intends to nominate him for this prestigious post. Reacting to this Jim Greenwood, president of the Biotechnology Industry Organization (BIO) said, "The President's nominee, Dr Lester Crawford, is an excellent choice to lead the FDA during this critical time. His regulatory experience across the consumer health and safety spectrum including medicine, agriculture and food safety will serve the agency well. Dr Crawford has done a remarkable job as acting commissioner of the FDA. His credentials and experience make him well suited to lead this critical consumer protection agency. We enthusiastically support Dr Crawford as FDA Commissioner. This nomination sends the right signal to patients and consumers, that there will be vision and leadership in the agency." "Because BIO's member companies are on the cutting edge of developing new pharmaceutical, biological and agricultural products, we depend on an FDA that embraces innovation while guarding the public health," Greenwood added. ]]> <![CDATA["We serve the needs of scienceâ€“based businesses"- Lisette Mermod-Cox, managing director, BDKT]]> https://biospectrumindia.com/news/95/1092/we-serve-the-needs-of-sciencebased-businesses-lisette-mermod-cox-managing-director-bdkt.html https://biospectrumindia.com/news/95/1092/we-serve-the-needs-of-sciencebased-businesses-lisette-mermod-cox-managing-director-bdkt.html Fri, 08 Apr 2005 15:51:00 +0530 What is the vision and mandate of the BDKT Consortium? The BDKT (Business Development and Knowledge Transfer) Consortium for Life Sciences Facilities was created to serve the needs of scienceâ€“based businesses. It is supported by the UK department of trade and industry to facilitate the export of British expertise in the area of pharmaceuticals, biotechnology and healthcare. It comprises 15 different British companies, all of which are established players in the UK. Today all the emerging life sciences markets are facing the trend of: maturation of the western market; change as a result of globalization; and employment of individuals through education. We bring in the western pharma experience to companies and countries looking at developing their own R&D expertise. BDKT facilitates the opportunity to export some of this knowledge and know-how to the emerging markets. In fact, we are looking to create a BDKT network in India to help transfer the know-how to the Indian market. Our Consortium has 15 different disciplines, which effectively makes us a one phone call resource for any company depending on whether they are start-up or a mature business looking to re-engineer. Does BDKT provide opportunities for Indian entrepreneurs as well? Absolutely. At the moment we are in touch with a very large Indian law firm to help correlate the two major biotech associations in India, ABLE and AIBA, in order to bring them in contact with the British biotech sector. There is an organizational need for trade associations to be more concise, to be able to provide presentation material on their member companies. We are going to massage the relationship to enable them to make a channel relationship with the biotech companies in the UK. We also help the Indian entrepreneurs more directly by offering a virtual incubator service. It is a program where a science partner can offer help to review business plans, help in building an international management team as necessary, help thinking about the globalization of the business and global marketing. Usually, it is a package that we offer to the science partner, and they in turn may offer it to the individual member companies. But if a company approaches us, we can also offer it directly to them. What are the biggest hurdles facing the Asian and Indian markets? I think that all emerging markets share the same problems. Business practice is one of the biggest challenges for any country that is inward looking and relatively closed for a long period of its growth time. Some of the communist countries, which have become members of the EU face similar problems. Effective globalization is putting pressure on Indian companies to adapt to an appropriate international business culture. This will directly affect the ability to engage contract, to exchange people, cross training programs. What do you perceive as India's biggest strength in this area? People and their quality. That is the only thing which matters. As the life sciences, health care and pharmaceutical sector constitute the knowledge economy. During the last 20 years, India has put more efforts in the education of innovators than any other economy on this planet. Many people may say that India has a cost advantage, but it is in the short term. The cost in India will go up like everywhere else. The costs have gone up in Poland, they have gone up in Hungary. It may not be as quickly but they will go up. How does India compare with China in this segment? Both India and China have tremendous challenges at the national government level to increase R&D and to be players in the knowledge economy globally. India has a tremendous advantage over China in its educated workforce. China has a lot to catch up. If you look at the numbers in India then in the area of R&D, right now the advantage is in India. The challenge for India when it comes to enterprise is that while the Indian economy is liberalizing, it is perceived that there is a greater distance between the Indian government and big business investing in India. In China, there is a perception that you can get to a decision-maker in the government very quickly, more directly and with an anticipation of a positive response. n Rolly Dureha ]]> <![CDATA["Biomedical Sciences is the fourth pillar of Singapore economy"- Dr Heng-Phon Too, associate professor, Department of Biochemistry, National University of Singapore]]> https://biospectrumindia.com/news/95/8250/biomedical-sciences-is-the-fourth-pillar-of-singapore-economy-dr-heng-phon-too-associate-professor-department-of-biochemistry-national-university-of-singapore.html https://biospectrumindia.com/news/95/8250/biomedical-sciences-is-the-fourth-pillar-of-singapore-economy-dr-heng-phon-too-associate-professor-department-of-biochemistry-national-university-of-singapore.html Fri, 08 Apr 2005 15:40:00 +0530 How is the Asian region developing in the area of biotechnology? This decade has been the era of Asian awakening. Most of the countries in the eastern region have been structuring and consolidating their stakes in biotechnology. China has set up a Bio-Valley in Shenzhen and to develop the field further, the ministry of science and technology is providing funds to the tune of $1.2 billion. Korea has recently started national initiatives in biotechnology and genomics and has put in $15 billion this year. Taiwan's domestic electronic industry is diversifying into biotechnology. It has set up a $30-billion biotech investment seed fund this year. Malaysia has also started and they are setting up a Bio-Valley too. India is developing the first Bio-IT Park in the world, while Singapore is strongly focusing on biomedical sciences. So everybody in Asia is gearing up. Why has Singapore chosen to focus on biomedical research? Singapore had been poised to launch a new direction in economic development post 2000. After the announcement of the first draft of human genome in June 2000, the government decided to launch biomedical sciences as the fourth pillar of industry. The focus on biomedical science was because of some good reasons. As opposed to the existing chemical, electronics and engineering industries, which faced regional competition due to low labor cost, the field of biomedical sciences has a "high barrier entry" as it is very capital intensive. It is a high-end industry and needs a lot of good, well-researched products. Secondly, Singapore does not have a lot of land. So animal culture or extensive agricultural research cannot be done. Hence we have to go to very high end just like Switzerland did. Moreover, the potential for the growth of the biomedical field is tremendous as against the agriculture and non-medical devices. The global human therapeutic industry will be worth $27 billion by 2008 and the human diagnostics will be about $4.3 billion. In addition, due to the manufacturing of some blockbuster drugs like Zantac in Singapore, it already has the necessary manufacturing plants/facilities. The vision is to develop Singapore into a world-class hub for biomedical sciences in Asia. With this ambition, the A*STAR (Agency for Science, Technology And Research) and other government agencies have aggressively set directions, gravitating the nation in building this fourth pillar of economy. Rolly Dureha   ]]> <![CDATA["We have to hard sell Indian biotech to UK" - Nitin Deshmukh, director, ABLE]]> https://biospectrumindia.com/news/95/2664/we-have-to-hard-sell-indian-biotech-to-uk-nitin-deshmukh-director-able.html https://biospectrumindia.com/news/95/2664/we-have-to-hard-sell-indian-biotech-to-uk-nitin-deshmukh-director-able.html Fri, 08 Apr 2005 15:01:00 +0530 What was the objective and outcome of your visit to UK? The primary objective was to get the first hand knowledge of the biotechnology policy initiative of the United Kingdom, the fiscal and other incentives, regulatory framework, the intellectual property protection framework, public private partnership and exploring opportunities for linking ABLE members with UK bioclusters especially Cambridge, and Oxford However, during the course of my initial meetings, I was taken aback at the perception of the UK biotech community on the aspect of intellectual property rights (IPR) protection in India. My visit therefore ended up trying to change the perception on India amongst the UK biotechnology community and on selling India using all the information I had on the potential of Indian economy and various accomplishments of the Indian pharmaceutical, biotech and the technology sectors. At the end, I must say I was pleased; that the companies, the intermediaries with whom I met all through have got more interested in India and evinced interest in initiating increased interactions with the Indian biotech sector, many of them keen to visit India during Bangalore Bio 2005 to have a closer look and feel of the biotech sector and explore potential collaboration opportunities. How you find the mood of the biotechnology industry players/associations in UK about India and the biotechnology industry in particular? As I said earlier, India certainly did not figure high in terms of preference for trade and collaboration for the biotech sector in the UK. There are certain preconceived notions about India's track record on IPR protection, which are clearly out of place in today's context with India complying with WTO on IPR and taking adequate steps for implementation of the same. There is also lack of quality information with the UK biotech sector about the Indian biotech sector/companies and the kind of high quality business/collaboration research that most of these biotech companies are doing with companies in the US, France, Germany, Australia, New Zealand etc. which could probably be the reason for ignorance. It is very clear to me that both of us have to work harder to clear these misconceptions quickly and I hope that my visit has contributed to one step forward in this regard. While I am aware of the initiatives and the work of the British Trade Office in Bangalore in this regard, ABLE along with the Department of Biotechnology, Department of Science & Technology and The Indian High Commission in UK will need to do a lot more to change this mood. What do you see on the next steps in improving the situation on exchange of quality information between respective biotech sectors? Clearly organizations like ABLE, BIA, the British Trade Offices, The Indian High Commission in UK will have to take a lead role in facilitating this information as well as interaction between the biotech sectors of India and UK. Players like ISIS, ERBI, Oxfordshire Bioscience Network, and London Technology Network etc. can be the platforms for such an exchange and we should work very closely with them to achieve our objectives. Of the many meetings you had with different companies in UK which companies interested you? I was impressed with the work done at Zenosis, which has developed a software product for information and training on regulatory issues for pharma and biotechnology sector in the US and UK and countries in Europe. It provides a comprehensive regulatory e- learning and knowledge building system that is uptodate and accessible online. I feel that the Indian pharmaceutical and biotechnology companies can benefit a lot from this product. Potentially we should explore Zenosis working with DCGI, DBT for developing a similar product for the India regulatory system. On the drug discovery side, ASTEX Technology doing some good work in the oncology space using a proprietary fragment based discovery platform/engine. Similarly in the drug delivery systems space, work done by PowderMed in immunotherapeutics using a proprietary DNA particle mediated epidermal delivery (PMEDâ„¢) technology was very interesting. What would be your 'take away' from this visit? Yes there was a lot to learn from some of the meetings that I had with say Dr Colin Wyatt at Imperial College, London, Jeanette Walker at ERBI, Dr Tim Cook and David Baghurst at ISIS and Ian Young and David Masino at Department of Trade & Industry. The Imperial College model of Business Development for Public Private is very interesting and can be a role model for similar research institutions such as AIIMS, GS Medical College etc. in India. Similarly ISIS is another good example of managing technology transfer from institutions to the private sector and seeding entrepreneurship at research institutions. Institutions like IISc, NCBS, CCMB can be good candidates to experiment with this model. ERBI too is doing good work on incubating companies and this could be a good model for biotech parks coming up in Bangalore, Hyderabad etc. On the biotech Policy side work done by Department of Trade & Industry (DTI) on the Business Innovation & Growth Team, Business Futures Forum, Biosciences Leadership Council and Biotech Clusters can be excellent inputs for us in our Biotech Policy and other initiatives of the Department of Biotechnology. Narayan Kulkarni     ]]> <![CDATA[Funds galore for biotech startups]]> https://biospectrumindia.com/news/95/7056/funds-galore-for-biotech-startups.html https://biospectrumindia.com/news/95/7056/funds-galore-for-biotech-startups.html Fri, 08 Apr 2005 14:58:00 +0530 The new year has started on a firm note for the biotech industry. The fledgling industry has several small and medium enterprise companies and most of them are struggling to get funds for expansion. "The government is keen on developing this sector. And it is considering setting up a Rs 1,000-crore fund for science research. It will remove all conflicts from Department of Science and Technology, Department of Biotechnology etc. We are also looking at setting up a $2-billion technology acquisition fund. Besides, the budget support for R&D has been growing. At present it is 1.2 percent of the GDP and it would reach 2 percent in next few years," said Dr MK Bhan, secretary, Department of Biotechnology (DBT), Government of India. Any announcement by the governments to dedicate funds to promote the industry is a welcome step. And such announcements will have a rub-on effect. The ministry of chemicals and fertilizers is in discussion with the Planning Commission to increase the corpus of the R&D fund to Rs 2,000 crore. According to reports, the government is seriously considering the proposal and sanction the same within this financial year. No final decision has, however, been taken. And it is planning to model the fund on the lines of research funds offered by governments of developed countries by inviting private participation - like financial institutions and venture capitalists to create a workable fund. The Gujarat government has announced the setting up of Rs 50-crore Gujarat Biotechnology Venture Fund. This 12-year close-ended state fund set up by Gujarat Venture Finance (GVFL) Ltd will invest in the biotechnology start-ups in the state. Despite the bullish feeling, the investor community is still shy of this sunrise industry, which is looking at seed and early stage funding. The biotech industry now needs to understand the expectations of investors and VC community and vice versa. The Association of Biotechnology-Led Enterprises (ABLE) organized "BioInvest" in Mumbai on March 11th. This was a meet to get a first hand account of the investors' views and their perceptions about this industry. The investor community, comprising people from the capital market, commercial banks and venture capitalists, participated in the meet to share their outlook on how to attract funds at early stage. According to Sarath Naru, managing director, APIDC-VC, 13 early-stage and 90 late-stage deals with investments worth of $2,197 million were signed in India in the last 24 months. Amongst these, eight deals saw $1 million or lesser in investments, about 43 deals were in $3-10 million range, and those above $10 million were 45. Coming to life sciences vertical during the same period, 17 deals were finalized with a total investment of $557 million at an average size $26 million. Only four deals were for early-stage investment, the rest were in the late stage of funding. Early-stage biotechs hit hard Early-stage biotech companies need to use different models to start with in addition to investment by early stage VCs i.e., they do not only depend on VCs. This is important considering that there are few VC Funds (APIDC-VC's and GVFL's biotechnology venture funds) doing early stage VC," said Sarath Naru. There are many hitches coming in the way of the VCs. These include lack of knowledge about this space, tightfisted valuations, slow decisions, shortage of value-adds, frightening documentation, divergent timeframes etc. It is not only the VCs even commercial banks are also hesitant in offering loans to the biotechnology industry. This is mainly because of the size of the companies, funding requirements, uncertain business models and financials, lack of assets for security purposes, lack of vibrant VC community to develop strong VC-commercial banking partnerships to reduce the required due diligence by banks and preference of banks to look at asset backed lending vis-a-vis cash flow based lending. However, a couple of commercial banks like Canara Bank and Syndicate Bank are offering personal loans to biotechnology professionals along with IT professionals. Commenting on the biotechnology sector from commercial banking perspective, Alok Gupta, country head, life sciences and biotechnology, Yes Bank Ltd said, "Not only in India, even globally the number of banks involved in financing early stage companies is very small and pure debt funding is more suited for medium or late stage companies with sustainable profits and positive cash flows. Increasing the awareness can lead the banks to look favorably at the biotechnology sector." Increased interactions the need of the hour To overcome the challenges several action points have been suggested. Some of the more important ones include educating the investors and VC community, government support to the bonafide early stage VCs, providing time management lessons for VCs, conduct of of joint workshops by the Indian Venture Capital Association (IVCA) and ABLE to understand the norms of the industry, and government's support for VCs with operating backgrounds. Naru observed that ABLE can make a big impact on VCs if it can go to the investors and the VC funds in India and tell them to support only VCs who are truly early stage and have investment management team members that have experience working with early stage companies and have biotech experience. ABLE's working with the Investors into Funds, and with institutions like TDB and NIMITLI will support the qualified VCs. Further, the entrepreneurs need to come up with big ideas that start small. "We as early stage VCs are looking for 'business propositions' that can become billion dollar companies in five to 10 years," said Naru. At the same time he called upon the investor community and VCs to understand the space better, to work to add real value and to take on more risk. A healthy venture capital industry is crucial to the industry. It provides the impetus to the entire financial chain, creates strong partnerships between VC community and proactive banks. Banks normally consider warrants to take advantage of the potential upside, thereby improving the risk-reward returns. Alok Gupta suggested encouraging banks to fund R&D initiatives, to provide channels for the banking finance to be routed into R&D and related areas, technology venture funds, infrastructure-BT parks, incubators etc. Do it yourself Most the biotech entrepreneurs, who are basically from academic background, enter the business with big ideas. As time passes they start looking for funds from banks to VCs to run the show. Their background pulls them back to look at various options before approaching the VCs. One among the key factors is valuation of the company. Valuation is one of the key components that VCs consider while considering the proposal of biotechnology entrepreneurs. Valuation has many uncertainties and complexities. Ronil Sujan, executive director, Rabo India Finance noted, "Biotech industry is at a nascent stage. It has very few valuation benchmarks available. Surrogates such as stock price volatility are unavailable in the Indian biotech market and Biocon is the only exclusive biotech company listed on Indian stock exchanges. The changing regulations and government policies in the biotech sector are also creating problems in valuation of a company." Ronil Sujan pointed out different parameters to valuate the company. The parameters include type of company - size, type of product base, business model, current life cycle stage; quality of management; number of products under development and stage of product development; survival index - ratio between cash on hand and burn rate (rate of expenditures required for R&D); level of intellectual property protection; government policy stability; domestic and international market dynamics; market sentiment (stock market, economy trends); insurance reimbursement trends; current and future availability of product substitutes) and collaborative partnerships with big pharma or larger or more established companies. Business plan Venture capital funding is different from lending. As biotechnology is hitech area, it requires a careful analysis of the project reports before the final sanction for the projects. Selective approach is very much essential. The VCs look at the proposals for proper and detailed business plan, which gives a clear road map about the company. "Clarity of business plan is more important rather than the form of the business plan. Clarity of the business idea where the values come from and competencies of the team should be clear. The plan should also include how to augment the gap that exists in individual teams and enhances the team's strengths," said Ajay Kumar Kapur, chief executive officer, SIDBI Venture Capital Ltd. How to prepare a business plan? "First identify the objectives, outline the business plan that includes executive summary, market analysis, company description, operational model, products and services, management and ownership, funds requirement and its uses, financial data and exhibits, review the outline, write the business plan, review the plan and update the plan," observed Utkarsh Palnitkar, industry leader, health sciences, Ernst & Young. Yet lucrative Biotechnology is still attractive. Nitin Deshmukh, director, ABLE noted that biotechnology like any other industry is a volatile business, yet it has had a positive ending in 2004. The life sciences sector in the US attracted $5.6 billion by way of venture capital in 578 companies - the largest dollars and deals in the last four years. This was 27 percent of all VC funding in 2004. One key factor to be noted is that the definition of biotechnology today has moved away from a narrow one of the products developed involving recombinant genetic engineering to technology in life sciences involving genomics, combinatorial chemistry, SNP's proteomics, systems biology etc. This has been extended to the development of products for human healthcare, agriculture, environment, bio industrial processing and bio suppliers. Young drug discovery companies have been increasingly getting identified as biotechnology companies. Making comments on the capital market, which is very important for the investors, Sanjay Bajaj, vice president, equity capital market, JM Morgan Stanley, said, "Despite the recent bull run Sensex does not appear to be overvalued as compared to global markets and the Indian market has been among the best performing markets over the last six months. The markets have reacted favorably to the Union Budget. Even the FII inflows were very strong with net FII inflow crossing $8.5 billion in 2004 and the flows were not restricted to only large cap companies. Even mid-caps attracted good FII interest. In 2005 too, FIIs have so far have pumped in more than $2.5 billion. Investor participation in the Indian new issue market continues to be extremely robust with recent offerings attracting many high-quality foreign investors. The Indian markets have matured to absorb large public offerings and investors have made good returns in recent IPOs." "Investors are uncertain about biotechnology. It is an ideal option to look at creating shared facilities in all the major cities to provide a common platform to support innovative R&D. Even the R&D spend in the country has gone up and people are becoming comfortable with utilizing the new technologies and things are now looking better. Ideas are floating around. The government feels that in the long run, the subsidy is not a viable option hence it rather looks at investing in R&D i.e., through public-private partnerships model," added Dr Bhan. VC funding is available but seed stage and early stage funding is still a day-dreaming for entrepreneurs. Vishnu Varshney, CEO, Gujarat Venture Finance Ltd said, "The government has a much greater role to play in the growth of biotechnology in India. Besides developing a robust regulatory framework and setting up biotech parks, I believe that an incubation fund for the early entrepreneurs can be started to whet their technology and processes before these entrepreneurs can approach a VC for a larger fund." "Definitely venture capital and private equity support are picking up in the country and innovation lead growth of the economy is a good sign. It is an essential thing to happen because venture capitalists can now balance the risk and thereby the business ideas will flourish with the support from the traditional finance," noted Ajay Kumar Kapur. n Narayan Kulkarni ]]> <![CDATA[Bt cotton gets green signal in North India]]> https://biospectrumindia.com/news/95/2018/bt-cotton-gets-green-signal-in-north-india.html https://biospectrumindia.com/news/95/2018/bt-cotton-gets-green-signal-in-north-india.html Fri, 08 Apr 2005 14:43:00 +0530 The March 4 meeting of the apex regulatory body, the Genetic Engineering Approval Committee (GEAC), saw the approval of six new varieties of transgenic cotton in the northern states of Punjab, Haryana and Rajasthan. This landmark decision of GEAC has paved way for commercial cultivation of transgenic cotton in these states for the first time. These approved genetically modified Bt cotton hybrids, engineered to provide resistance against the American bollworm, are MRC-6301 and MRC-6304 of the Jalna-based Maharashtra Hybrid Seeds Company (Mahyco), RCH-134 and RCH-138 of the Coimbatore-based Rasi Seeds and Ankur-651 and Ankur-2534 of the Nagpur-based Ankur Seeds. With this, the total tally of Bt cotton hybrids approved for cultivation has climbed up to ten. The first approval was granted in 2002 to three Bt cotton hybrids of Mahyco (Mech-162, Mech-184 and Mech-12) and last year, RCH-2, the Bt cotton variety of Rasi Seeds was given the green signal for cultivation in Central and Southern India. The Genetic Engineering Approval Committee (GEAC) which met on March 4, 2005, took the following decisions with regard to Bt cotton: â€¢ Six new varieties of Bt cotton were approved for commercial cultivation in the northern states of Punjab, Haryana and Rajasthan. The approved cotton varieties are MRC-6301 and MRC-6304 of Mahyco, RCH-134 and RCH-138 of Rasi Seeds and Ankur-651 and Ankur-2534 of Ankur Seeds. â€¢ The renewal of the Bt cotton varieties being planted in the southern parts of the country has been deferred to the next GEAC meeting (to be held on April 13). â€¢ This is believed to be because of allegations from the NGO GreenPeace regarding discrepancies in data. Some discrepancies were noted in the data from Warangal district of Andhra Pradesh, and the GEAC has asked the state government to submit a report. â€¢ Large-scale trials of six varieties of Bt cotton have been permitted in North India. The permitted varieties for trials include two varieties each from Mahyco, Rasi Seeds, and Nuziveedu Seeds.   The GEAC's decision has led to a wide range of reactions ranging from outright disapproval from some of the NGOs to wholehearted support from the industry organizations. Says Bhagirath Choudhary, national coordinator of International Service for Acquisition of Agri-biotech Applications (ISAAA): "It is a great news for the farmers in the northern part of India which consists of six major states. You might remember that northern states like Punjab, Haryana and UP are the food baskets of India. The first Green Revolution was ushered in India through the fields of these three states. We are happy that the GEAC has approved six hybrids in these states where farmers would benefit the most. These hybrids would provide a "Combo" offer against Bollworm (Bt in hybrid) and Curl Leaf Virus (best available hybrids against CLV) in the northern parts". Dr Suman Sahai, convenor, Gene Campaign, countered, "It is absurd that before there is any review of the reported bad performance of the Monsanto cotton and large scale defiance of the refuge management requirement, the GEAC has gone ahead and approved new varieties for Punjab, Haryana and Rajasthan. There seems to be neither will nor capacity in the GEAC to control the serious problem of illegal Bt varieties; their only interest seems to be in releasing new GM crops. One must seriously question this." At present it is estimated that about 30-35 percent of the cotton growing area in the northern zones is under illegal (or spurious) cotton cultivation. It is believed that the GEAC had received specific requests for the quick approval of Bt cotton from the Punjab and Haryana state government as the farmers were being lured by the illegal cotton varieties. After long deliberations on the pros and cons of the technology, these varieties were cleared. Now the approval is expected to curb the illegal rampant sale and reduce the intensification of the cultivation of rice and wheat in the northern region. The companies concerned are upbeat about the committee's decision and their mood is reflected in MG Ramasami, managing director, Rasi Seeds. "We welcome this move and we are getting ready to place RCH 134 and RCH 138 variety seeds in the market by the first week of April. At present the demand for hybrid Bt cottonseeds is very high and I am not sure if we will be able to meet the requirements. Now the farmers will have access to legal varieties. The merits of our hybrid seeds have been demonstrated last year but I am doubtful if we are equipped to cope up with the huge demand arising from the northern region," Ramasami said. Overall, the industry believes that this is a positive step. As RK Sinha, executive director, All India Crop Biotechnology Association points out, "The crux of the matter is what the farmer needs. Till now in the northern region the farmers were just not bothered about the legal status of the cotton seeds. They were going ahead and planting whatever seeds they could source - illegal or spurious varieties. So it is a good decision to provide them the legal seed, which brings them the support infrastructure of the companies." The fate of Bt cotton now will be determined by how these varieties will perform when they go to the fields. n Rolly Dureha   ]]> <![CDATA[Biotech Gets Priority in Pakistan]]> https://biospectrumindia.com/news/95/7286/biotech-gets-priority-in-pakistan.html https://biospectrumindia.com/news/95/7286/biotech-gets-priority-in-pakistan.html Thu, 10 Mar 2005 13:20:00 +0530 Biotechnology is now engulfing several countries in the South Asian region. While China and India are leading the race, other countries too want to make progress with biotechnology development. India's immediate neighbor Pakistan too has launched itself into biotechnology development in a small way. Though at the moment there is no cultivation of genetically modified crop in Pakistan, it sees biotech in agriculture, healthcare and industrial sectors as a priority area. And it expects to have modern biotech companies in the next year. Dr Anwar Nasim, chairman, National Commission on Biotechnology in Pakistan, reasoned, "Pakistan is predominantly an agriculture-based economy. Agriculture accounts for the 24 percent of Pakistan's GDP. It covers a total area of 19,671 million acres of which 5,411 million acres are cultivated. It is a country of over 150 million people. And biotechnology can help us a lot." The modern biotech industry in Pakistan is extremely small. "Using traditional means, our ancestors were breeding animals and growing crops of different varieties and these common practices have damaged the cultivated land through water and wind erosion, compaction, salination and water logging. To overcome the impending shortage in this field, conventional methodologies have to undergo a paradigm shift. Thus the government is primarily focusing on various aspects of agricultural biotechnology," explained Dr Nasim. But Pakistan has seen a lot of work using traditional biotechnology methods. It has created many new plant varieties. The government is understood to have laid strong foundations for biotechnology in a coordinated way. "The Ministry of Science and Technology has in fact invested over Rs 100 crore in various projects," informed Dr Nasim. There are 27 government institutes and universities working in the field of biotechnology. "The main thrust of most of these institutes has been development of genetically modified crops that are best suited to our environment and can increase the productivity of the crops with minimal environmental hazards," he added. Pakistan has a National Commission on Biotechnology. The Commission is an advisory body to the Ministry of Science and Technology to help monitor new developments in the field of biotechnology at national and international levels and it recommends appropriate measures. The Commission comprises 14 members, which includes expert agriculturists, environmentalists, industrialists and scientists. There is no national biotech policy and the National Commission is studying various regulations, especially the developments happening in India so that it can formulate one on similar lines in Pakistan. Pakistan will soon be coming up with its own biosafety norms. According to Dr Nasim, the National Commission for Science and Technology chaired by the President of Pakistan has declared biotechnology as one of the highest priority are among the selected research fields. A project has been launched to improve research in agriculture, livestock, and medical sectors at universities and R&D organizations. Under the project liberal grants are being made available for active research scientists working in this field. Further, the private sector is also being encouraged. Dr Nasim informed that Pakistan is keen on initiating an Andhra Pradesh model for Faisalabad. At the moment biotech development is happening in Faisalabad, Islamabad, Rawalpindi, Jamshoro, Karachi, Lahore, Multan, Peshawar, and Quetta. The biotech research in Pakistan is carried out in the National Institute for Biotechnology and Genetic Engineering (NIBGE), Faisalabad, the Centre of Excellence in Marine Biology (CEMB), NFC Institute of Engineering and Fertilizer Research, National Institute of Leather Technology, and Pakistan Council for Scientific and Industrial Research (PCSIR) Laboratories. The next step forward for Pakistan is to build business relationships and kick-start the biotech activity, said Dr Nasim. During BioAsia 2005, few companies from Pakistan signed agreements with some of the leading biotech companies from India-Bharat Biotech, Natco Pharma, Otira Pharma. Ch. Srinivas Rao with Sunitha Natti, CyberMedia News in Hyderabad "We are here to explore Biotech trade" Dr Anwar Nasim, chairman, Pakistan National Commission on Biotechnology With developing countries joining the joint venture bandwagon in biotech, India's immediate neighbor is no different. To increase the domestic production of biotech products, a six-member delegation from Pakistan was in Hyderabad to try out the technology transfer pacts with Indian companies. This delegation was headed by Dr Anwar Nasim, chairman, the Pakistan National Commission on Biotechnology. He is also the president of the Federation of Asian Biotech Association (FABA) and science advisor for OIC Standing Committee on Scientific and Technological Cooperation (COMSTECH). Dr Nasim is trained in genetics and has edited over 45 books. In this exclusive interview, he shares his vision and developments in Pakistan. Could you give an overview of the biotech scene in Pakistan? Pakistan is still in the nascent stages as far as the biotech industry is concerned. We have only 10-12 pharma firms worth the names in this business. Precisely, we are entirely dependent on the Western firms and health bodies like the World Health Organization (WHO) for our domestic needs. And the key to growth is by establishing strategic tie-ups with Indian firms to develop the country's biotech sector. What are your present trade links? The Pakistan government has recently listed nearly 150 finished products that can be imported from India. Three companies in Pakistan have already started trading with Indian firms thereby shipping products into our country in the space of vaccines, snake venom and intermediaries. It could also be said that more five to six such collaborations are in the pipeline. And the six-member delegation was at the BioAsia 2005 conference to explore trade possibilities with Indian counterparts. What is the status of your biotech R&D activity? It is a well-known fact that research in the biotech industry needs enormous amount of money and time. Though the activity on this front is quite negligible so far, the government is really extending support in all possible ways and this is quite encouraging for companies. One way to do this is to promote research with joint collaborations and the other ways to improve the biotech industry is establishing deals with biotech and pharmaceutical companies. Equally, there needs to be a strong connection between the industry and research institutes and academies, which is a little bit weak at present but is improving at a faster rate. Prospects of the industry are still a challenge but all-out efforts are being made to spell out success. What are the main objectives of your Commission on Biotechnology? The mandate of the Commission is to focus on human resource development, strengthening research facilities, funding young researchers for projects of high priority, strengthening government-private sector collaboration, creating awareness and encouraging research, which increases export. It has been decided that initially special attention should be paid to human resource development and in view of the limited resources. Agriculture and health will be the top priority areas. You have been instrumental in setting up the FABA. What do you wish to achieve? The FABA has been set up to promote and safeguard the overall interests of biotechnology as a science, profession, industry and trade in Asian countries. We will coordinate and cooperate with other federations and associations in the world, collect information and sponsor study and business teams traveling to other countries. We already have eight members and plan to increase the same during the year. ]]> <![CDATA[Bio-Hands for Tomorrow]]> https://biospectrumindia.com/news/95/6220/bio-hands-for-tomorrow.html https://biospectrumindia.com/news/95/6220/bio-hands-for-tomorrow.html Thu, 10 Mar 2005 12:45:00 +0530 Dr Krishna M Ella Chairman and managing director, Bharat Biotech International Ltd (BBIL), India Indian Biotechnology is gathering momentum. After decades spent in debating its tangible benefits, the scientific world rediscovered its immense potential only in the last one and half decade. Indian biotech industry is expected to grow to $1.45 billion in 2005-06, $4 billion in 2006-07 and more than double that figure - $9 billion in 2007-08. (Source: Survey finding by BioSpectrum and CII ) The singleminded and dedicated efforts of illustrious scientists such as Prof. R A Mashelkar and Prof. G Padmanabhan and others, have brought this science that can develop life-saving vaccines to combat infectious diseases and path-breaking therapeutics to counter congenital and acquired disease patterns of the world, to the forefront of scientific research and development. Over the next few years, India is slated to become a major center for custom research, and clinical and biological services. It is already the second largest manufacturer of vaccines used by children and these are exported to over 100 countries. With the introduction of the product patent regime in 2005,biotech firms in India are preparing themselves for an intense phase that would test the ultimate enterprise and intuitive knowledge of Indian scientific and industrial community. Human resource issues The rate at which the biotechnology industry in India is progressing is heart-warming. But the same cannot be said about human resources in biotechnology. There are several issues that need to be tackled to ensure the progress that has been made in this sector. The issues can be divided into six main aspects:  Biotech curricula Training in practical aspects Forging industry-academia partnerships Creating policy framework Creating awareness about biotechnology Nurture and promote bioentrepreneurship Biotech curricula: The course content of biotechnology as a subject in India needs an immediate relook. Unlike pharma education, which is historically well established with organized syllabus, adequate lab exposure and training, biotechnology curricula is still evolving. Due to lack of exposure, many colleges and universities in the country offering biotech courses are not offering a standardized content material. The course content seems to swing between being either too academic or too general without any specific, well-planned practical training or lab exposure. The faculty, too seem unaware of the revolutionary changes taking place in industrial biotechnology in the areas of production, R&D, GMP guidelines among others. One look at the student output in biotech reveals 1,50,000 M.Scs, 3,50,000 B.Scs, fewer post-doctorals compared to the US, and majority have no exposure to industrial research. This puts biotechnology students at a disadvantage when they set out to carve their career path in the industrial sector. To fulfil the above requirements, it is important to create a learning program in the area of biotechnology and its ancillary fields. The need of the hour is to envisage a multidisciplinary curriculum that will cover all aspects of biotechnology including understanding process principles, experimentation, animal and plant technologies, bioinformatics, basics of project management, IPR issues, business values and finances in BT. I propose we create separate modules for students and corporates, which will focus on different themes. The student course will emphasize on practical hands-on training, teaching the ethics of GLP and a fundamental know-how of BT management. Practical training: Unlike IT courses where lab exposure is minimal, it is imperative that we understand the significance of providing hands-on experience for biotechnology students. Vocational courses: The BSc course in Biotechnology was started in a few colleges in the country, about a decade ago, as a vocational programme of the UGC, with UGC's syllabus, guidelines and financial support. But subsequently, several colleges in the country were given affiliation for BSc Biotechnology, ignoring UGC's norms regarding sanctioning vocational courses, with the same regulations and syllabus. This needs to be addressed immediately. Creating vocational courses will ensure a steady stream of HR for Biotech industry. This will spark off another essential aspect â€“ Entrepreneurship. I would like to add that in this aspect, women can play a vital role in changing the dynamics of industrial biotech. This would encourage women entrepreneurship in creating ancillary industries that support and nurture biotech industry in India. I propose that the state governments and the DBT, with the certainly feasible support from and collaboration with the industry, establish instrumentation and training centers at a few key locations in different states, where students can get trained and research workers can get instrumentation services on payment of prescribed charges so that expensive facilities required for most of education and training in biotechnology need not be duplicated. Continuing education for professionals: Taking one step further, it is imperative to create educational opportunities for professionals from related fields such as pharma to hone the necessary skills for creating their career path with biotechnology industry. The Council (* As per my proposal) could actively create educational resources, self-training modules, information about advanced courses, research and fellowship opportunities, and links to various conferences and meetings around the world. Each of these tools for continuing education has its own advantages and disadvantages. For example while online tools provide the benefits of a self-paced environment for learning, conferences allow discussion and generation of new ideas. Example: The World Health Organization's Human Genetics Programme that aims to support an educated and informed health workforce to provide the best health services to populations worldwide and to achieve the best possible health for all. My Suggestions â€¢ Create courses on biotech equipments and technology â€¢ Create short-tem & long-term courses on bio-safety â€¢ Create specific specializations on patents and IPR â€¢ Increase course content on regulatory frameworks â€¢ Include biotech in marketing and allied subjects â€¢ M.Sc students should be given six month short-term scientific projects at CSIR Laboratories â€¢ Students should be encouraged to take up specializations in GMP, GLP, DCP, Validation and Q.A â€¢ Promote industry-academic partnerships in establishing training centers â€¢ Create vocational courses in biotechnology â€¢ Encourage women to take up vocational courses â€¢ Faculty should be updated every year about current trends in industrial research â€¢ Continuing education for professionals Forging industry-academia partnerships: In the last two decades a new entity has emerged on the campuses of America's research universities. This entity is known as the University-Industry Research Center or UIRC. Such centers are composed of research groups whose focus is on problems that have relevance to a particular sector of industry; often the centers receive support from that industry. In 1990, more than 1,000 existed and involved more than 35,000 faculty and researchers and 17,000 Ph.D. students. Many more exist today. Why are universities creating such centers? Strictly speaking, universities are not creating them. In an extensive survey of UIRCs, it was determined that individual faculty members, not university administrations, typically provide the impetus for the center. Motivations vary, but the need to create funding alternatives to declining or uncertain federal support is important, as is the desire to turn research efforts to a practical end. Additionally, nearly one quarter of all U.S. Ph.D. recipients in the sciences are finding positions in industry; so students are looking for training that is relevant to their career prospects. In India, Bharat Biotech has set such an example: The Bharat Biotech Foundation is recognized by JNTU, Hyderabad. to execute academic research through a Doctoral Programme in Biotechnology. From an institutional viewpoint, centers like the above cited ones represent one way that the value of academic research can be realized to benefit the institution. Creating Policy Framework: Biotechnology plays an important role in the economic development of the country in sectors like medical, human health, animal health, pharmaceutical/new drugs, agriculture and environment and it is indeed laudable that the Department of Biotechnology has identified human resource development as an area of high priority during the 10th five year plan in order to generate trained/skilled human resource in this critical and high tech. area of biotechnology. But creating a specific framework is the need of the hour. Let me quote this example. Currently there are four categories of M.Sc., course in biotechnology in the country supported by the UGC, the Department of Biotechnology, the AICTE (in engineering colleges), the University system. As a result there is a lack of uniformity in requirements, the quantum of financial support and the consequent lowering standards of education. In view of this distressing situation, which threatens to soon seriously defeat the national effort to derive benefits from biotechnology, I stress the need to put in place a Biotechnology Council of India (BCI), an independent statutory national body, on the lines of the Medical Council of India, Dental Council of India, Pharmacy Council of India, All India Council for Technical Education and the Bar Council of India. The chief role of such a statutory body would be to ensure standardization in biotechnology education and training in the country. The BCI should be empowered to grant recognition for those institutions that meet such standards, set with reference to qualified and trained teaching staff, infrastructure, adequately equipped laboratories, etc., that are essential for a focused education in biotechnology. Creating Awareness: The most vital of all the current issues is increasing awareness about biotechnology. Towards this biotechnology popularization, the proposed Council could organize seminars, symposia, conferences, workshops, popular lecture series, biotechnology publications in various languages, organize biotechnology exhibitions, national science day celebrations in universities and institutions. Promote Bioentrepreneurship: Despite the efforts of thinkers, biotechnology in India, for a long time, remained in the safe waters of premier, academic and scientific institutions. Thoughts of one scientist illustrates this - "Scientists are not supposed to think about the economic perspective on research and development projects. A scientist's work is supposed to provide scientific knowledge. Economics is quite another discipline..." This mindset has to change. This decade, which is all set to see a biotechnology boom, will belong to those who have the power to convert their dreams into reality. In other words, it will see the rise of the bioentrepreneur. The ones who will move away from the safe waters of the laboratory and convert a patentable/testable research dream into a viable business proposition. India has the potential to become very strong in biotechnology. There has been a phenomenal increase in the number of start-up companies in this area in the last five years. While the current size of the industry is $700 million, it is expected to grow at 25-30 percent. India ranks third in Asia in patent filings. Every bioentrepreneur must thoroughly understand the grassroots features of the biotechnology sector such as research, collaboration, infrastructure, technology and commercialisation capital and come up with an alternative business model to achieve success. ]]> <![CDATA[The Age of Theranostics]]> https://biospectrumindia.com/news/95/2060/the-age-of-theranostics.html https://biospectrumindia.com/news/95/2060/the-age-of-theranostics.html Thu, 10 Mar 2005 12:35:00 +0530 Kiran Mazumdar-Shaw CMD, Biocon Ltd and president, Association of Biotechnlogy-led Enterprises, Bangalore. Medical practice is undergoing a radical transformation in the post-Genomic era where disease management is demanding more advanced diagnostics that are designed to work on an individual rather than a population level thus spearheading the age of personalized medicine. Future trends indicate that diagnostics will need to focus on the internal manifestation of the disease i.e. genotypes rather than the outward manifestation of disease which are based on symptoms that physicians refer to as "phenotypes". The era of pharmaco-genomics The seeds of personalized medicine were sown in 1998 at Mayo Clinic, Rochester, USA when a team led by Dr Weinshilboum made a groundbreaking discovery that explained why a childhood leukemia drug, Azathioprine, which proved efficacious in most children, caused fatality in some. The fatality was pinned down to a missing enzyme, TPMT (Thiopurine methyltransferase) which led to the build up of the drug and caused acute bone marrow failure. The missing enzyme was attributed to a faulty gene and thus began the era of "pharmaco-genomic medicine". Since then, a large number of commonly used drugs have been known to have variable drug responses thus questioning the "one drug fits all" approach taken by pharmaceutical companies. In the recent past, several drugs have failed on account of extremely variable efficacy which in most cases is attributable to genetic mutations. A good example of this is Astra Zeneca's drug Iressa for Non Small Cell Lung Carcinoma which proved to be efficacious in only 10 percent of patients, eventually linked to a specific gene mutation. Genentech's Herceptin, a monoclonal antibody for breast cancer is likewise dependent on the over expression of the HER 2 gene. Theranostics The new medical approach to disease management looks at disease as a process rather than a state, where tracking disease progression will allow for better therapy. Gene regulation and other bio-algorithms will form the core of a new wave of diagnostics that are now being referred to as "theranostics." Theranostics are designed to diagnose diseases at their stage of progression to enable the careful and accurate selection of a treatment regimen and further to monitor the patient's response to the said therapy. In short, theranostic tests can determine a patient's response to a specific drug therapy, or guide and assist in choosing the correct and most efficacious treatment regime. Companies such as Roche Diagnostics, Millennium Pharmaceuticals and others are investing in this nascent sector. The European Diagnostic Manufacturers Association (EDMA) believes theranostics, pharmacogenomics and genetic testing are the new market drivers for medical intervention and preventative medicine, aimed at providing improved and cost effective healthcare. Bayer Diagnostics forecasts that the theranostics market will grow by 20 percent per year until 2010. India as the hub for differentiated medicine India offers, perhaps, one of the most affordable development bases for personalized medicine. Developing well validated personalized therapies will demand extensive clinical data to be generated from well differentiated patient populations. India and China are clearly the two countries with the most desired disease and patient profiles that can enable such studies. Coupled with this is the need for a large number of novel diagnostics based on gene and non-gene based platforms that are both predictive and qualitative in terms of disease status. These are clearly large opportunities for Indian biotech companies to pursue. Personalized drugs also address the affordability factor for expensive therapies such as those that are involved with cancer where early diagnosis and new diagnostics can substantially reduce dosages and even eliminate expensive chemotherapy in certain cases. IT and new medicine The advent of personalized medicare will require a strong informatics approach that combines both software and biotech skills in augmenting high-speed data mining of both genotypic and phenotypic information with a view to evolving new forms of medical diagnostics and therapies. Genomics and Proteomics are churning out endless reams of data which need to be statistically evaluated and harnessed for commercial end use. India has a powerful advantage in addressing these emerging opportunities in personalized medicine through its well developed capabilities in information technology. It is envisaged that in the years ahead there will be a number of collaborative initiatives between software, biotech and pharma companies. The healthcare challenge Healthcare bills all across the world are mounting. Whilst developing nations are burdened with infectious diseases, AIDS, TB, diabetes, SARS and the like, developed nations like the US, Japan and European countries are seriously addressing the burden of diseases caused by their aging populations. Both types of disease burdens will have to focus on preventative medicare. Developing countries will need to invest in large scale immunization whilst the developed world will need to manage "wellness". Both approaches have to find innovative ways to minimize hospitalization and surgical interventions. Managing "wellness" as opposed to treating "illness" is therefore the new mantra for health care management the world over. India's window of opportunity Although India is well positioned to address these emerging opportunities in personalized medicine, government policies are not in place to take full advantage. Investment is inadequate, funding is still scarce, infrastructure is expensive and regulatory regimes are deficient. These trends in modern medicine will not wait for India to get its act together. India has but a narrow window to seize these opportunities. There are hopeful signs in the right direction: There is already a perceptible paradigm shift in the research culture in our scientific institutions which seeks to partner more closely with Indian industry. Added to this is the re-orientation of our hospitals and medical centers from merely delivering medical services to research based disease management. These institutions are rapidly transforming themselves into high quality clinical development hubs for new drugs, new devices, new diagnostics and new therapies. Gene therapies and stem cell therapies are slowly making visible progress the world over. Given the strong political support that stem cell research receives in India, it is important to make rapid strides in this nascent domain to surge ahead of other more scientifically advanced regions that are mired with political and religious road blocks. The success of building a global business in personalized medicine is going to depend on the ability of Indian biotechnology to apply its people resource in a knowledge intensive manner to create unique niches in pharamco-geneomics, clinical research and new therapies and for government on its part, to provide an enabling regulatory environment that will make all this possible. ]]> <![CDATA[â€œThere is a Good Market Potential for Micro Arrays in Indiaâ€?Â ]]> https://biospectrumindia.com/news/95/1688/there-is-a-good-market-potential-for-micro-arrays-in-india-.html https://biospectrumindia.com/news/95/1688/there-is-a-good-market-potential-for-micro-arrays-in-india-.html Wed, 09 Mar 2005 18:04:00 +0530 What is the potential for micro array tools in India? There is a good market potential for micro arrays in India with the growth of biotechnology. It is emerging in India but not as much as you see in the US and Europe. Some of the people, I met in the Indian industry, have expressed the desire to use micro array technology tools for research and development. So in the next one or two years, it will surface as researchers will start using the technology and tools of micro arrays and also get trained in it.  What will be your focus areas in India?  The focus will be on big pharmaceutical and biotechnology companies. Corning has a diversified portfolio including glass and ceramics, optical fiber, display technologies, environmental technologies and life sciences. Corning has brought together its core competencies in biophotonics, surface chemistries, and biochemistry to generate innovative solutions for drug discovery and research. The drug discovery and development branch of the life sciences division develops and offers tools and technologies for cell culture, bioprocessing, lead ID and for microarray fabrication and processing. Hence we look at positioning ourselves in pharmaceutical as well as biotechnology space in the country.  What is the total market size for micro array tools? According to reports, the global market size for micro arrays is about $400 million. South East Asia, specifically India and China, account for about 2-3 percent share. Worldwide about 100 companies are using these tools. This includes the companies providing different surfaces, surface chemistry, enzymes, aligo content equipment providers, fabrication of micro arrays etc.  What is your observation of the Indian players?  The main focus of the Indian companies is towards contributing functional genomics and not on micro arrays. It is an informatics part. Over the past two years, a few companies like Strand Genomics have been working in these areas and have come out with informatics tools that would serve the backend part of micro arrays for data mining, data analyzing and data acquisition and so on. The initial trends are towards providing services.  Do you see any competition from Indian companies five years down the line?  We do see competition but not at the present stage. Several companies from the West are establishing their branches in India to develop software tools, taking advantage of the software skills of Indians. Indian companies will catch up as they do have the capabilities and talents to develop micro array tools. However, early movers will have an advantage.  Narayan Kulkarni in Mumbai ]]> <![CDATA[M&As among BioSuppliers Continue]]> https://biospectrumindia.com/news/95/1856/mas-among-biosuppliers-continue.html https://biospectrumindia.com/news/95/1856/mas-among-biosuppliers-continue.html Wed, 09 Mar 2005 18:01:00 +0530 Pall Corp. acquires Euroflow Pall Corp. acquired Euroflow (UK), a leading manufacturer of pilot and production scale chromatography columns for the biotechnology industry. Pall held exclusive global marketing and distribution rights to Euroflow chromatography columns and associated technologies since 2002. Euroflow sales are currently about $5 million a year.  Pall earlier acquired BioSepra Process Division of Ciphergen Biosystems Inc. BioSepra was strong in chromatography sorbents used in protein purification. These acquisitions now allow Pall to provide a complete fluid management system. Eric Krasnoff, chairman and CEO, Pall Corp., said, â€œWe are responding to the industry's request for integrated systems solutions for purification technologies from development through large-scale production.â€?  Thermo Electron to acquire Kendro  In another development, Thermo Electron Corp. entered into a definitive agreement to acquire the Kendro Laboratory Products division of SPX Corp. for $833.5 million in cash, subject to a post-closing balance sheet adjustment. Kendro is a major supplier of laboratory equipment for sample preparation, processing and storage used primarily in life sciences and drug discovery laboratories and in clinical laboratories.  PerkinElmer acquires Elcos AG PerkinElmer Inc. has acquired Elcos AG, an European designer and manufacturer of custom LED (light emitting diode) solutions for biomedical and industrial applications. â€œElcos has a successful track record of delivering high performance LED solutions with a majority of its revenues coming in from biomedical instrumentation,â€? said John Roush, president, PerkinElmer Optoelectronics. Nasan Medicals launches PeriScope Pune-based Nasan Medicals, in association with Hyderabad-based Genesis, developed a cardiovascular risk analysis system, PeriScope. According to YB Samant, director, Nasan Medicals PeriScope is a revolutionary, simple, economical and non-invasive screening and diagnostic tool that would pick up very early indications (even 5-8 years before) of diseases of the heart and blood vessels that cause heart attack, paralysis and kidney failure. "If detected early, such diseases can be prevented by simple medication or by mere a change in life style, saving one from high cost and high risk surgeries that need to be performed when it becomes an event like heart attack, kidney failure or paralysis," Samant said. PeriScope records ECG and blood pressure and presents it in the form of an actionable report giving the percentage heart, vascular and blockage risks through a simple painless test that takes less than 15 minutes, which does not even require a pre or post test preparation like fasting, injections or medication. - Nanda Kasabe (CyberMedia News), Pune Imperial ranked the best distributor of Stratagene Chandigarh-based Imperial Bio-Medics has emerged as the "best distributor" of Stratagene worldwide for 2004. Over the last three years, Imperial grew Stratagene business by about 159 percent. "This was made possible by the team's indefatigable spirit to win," said Neeraj Gupta, corporate vice president, Imperial Bio-Medics. This growth in Stratagene's business encompasses all products categories-mutagenesis, RT PCR systems, cloning, PCR enzymes, libraries, nucleic acids analysis, etc. The company in 2003-04 registered an 80 percent growth, recording a turnover of Rs 10.2 crore. Fabtech sets up new facility Fabtech Technologies has set up a new facility at Umergaon in Gujarat. To start with, Fabtech will manufacture sterilizing tunnels. The first phase of the facility is nearing completion and is being a built over an area of 2000 sq meters. In the second phase, the facility will be further expanded to accommodate more equipment. "The plan is to make this facility fully independent and capable of delivering the full range of Fabtech equipment, "said K Aasif, director, Fabtech Technologies International Pvt Ltd. Nasan Medicals launches PeriScope Pune-based Nasan Medicals, in association with Hyderabad-based Genesis, developed a cardiovascular risk analysis system, PeriScope. According to YB Samant, director, Nasan Medicals PeriScope is a revolutionary, simple, economical and non-invasive screening and diagnostic tool that would pick up very early indications (even 5-8 years before) of diseases of the heart and blood vessels that cause heart attack, paralysis and kidney failure. "If detected early, such diseases can be prevented by simple medication or by mere a change in life style, saving one from high cost and high risk surgeries that need to be performed when it becomes an event like heart attack, kidney failure or paralysis," Samant said. PeriScope records ECG and blood pressure and presents it in the form of an actionable report giving the percentage heart, vascular and blockage risks through a simple painless test that takes less than 15 minutes, which does not even require a pre or post test preparation like fasting, injections or medication. - Nanda Kasabe (CyberMedia News), Pune ]]> <![CDATA[Spinning a silken revolution]]> https://biospectrumindia.com/news/95/4126/spinning-a-silken-revolution.html https://biospectrumindia.com/news/95/4126/spinning-a-silken-revolution.html Wed, 09 Mar 2005 17:57:00 +0530 India produces 18 percent of the world's silk as compared to 69 percent produced by China. In fact, India's present overall silk production falls short of even the domestic demand. Realizing the need to improve sericulture practices and infuse modern technology into this agroforestry-based cottage industry, the Department of Biotechnology (DBT) in association with Central Silk Board (CSB), identified biotech techniques to increase productivity, enhance silk quality and improve host plants. DBT initiated a focused program on seribiotechnology and so far over 60 R&D projects have been supported involving various leading institutes including IISc, Bangalore; NII, New Delhi; NBPGR, New Delhi; NCL, Pune; CDFD, Hyderabad; CCMB, Hyderabad; IIT, New Delhi; IIT, Kharagpur; MKU, Madurai and University of Delhi, Delhi along with various centers/institutions of CSB. IPM Program: At the Central Sericultural Research and Training Institute (CSRTI), Mysore, an Integrated Pest Management (IPM) package has been developed for the control of Uzifly (a dreaded pest of silk cocoons leading to large-scale destruction of silk) at field level. The implementation of IPM package resulted a suppression of 77 percent in Uzi infestation. Now the officers from 59 cocoon markets and State Sericulture Department of Karnataka have been trained in mass multiplication and release of parasitoid -Nesolynx thymus, which feed on the Uzi flies. Presently the parasitoid is being multiplied regularly in 20 major cocoon markets for release in markets and supply to sericulture farmers. Silkworm as a bioreactor: Apart from increasing silk productivity, efforts are being made to develop silkworm as a bioreactor for producing biomolecules of commercial importance. Expression of marker proteins (luciferase and green florescent protein) has been successfully achieved in cell lines and larval caterpillars of silkworm (Bombyx mori) employing recombinant Bm NPV vector harboring reporter genes. Studies are being conducted for production of a few veterinary vaccines using the system. The Rabies, PPRV (Petid de Pet Ruminant Virus) and Rinderpest viral antigen proteins have been expressed using the system and efforts are on for further scale up and testing studies.  Silkworm genome program: An ambitious silkworm genome program has been initiated at the Centre for DNA Fingerprinting and Diagnostics (CDFD), Hyderabad to identify and map useful genes of silkworms using molecular techniques. This will helping in breeding better silk worms and developing transgenic silkworms with desired traits. About 400 different types of DNA markers have been developed in the silkworm.  The Andhra Pradesh State Sericulture Research and Development Institute in collaboration with CDFD has already developed three productive silkworm hybrids namely Swarnandhra, Hemavathy and Kalpatharuvu by adopting a combination of conventional selection, hybridization and DNA technologies. These hybrids give consistent silk cocoon yield and internationally graded raw silk. India is now participating in â€œInternational Consortium on Lepidopteran Genomicsâ€? along with seven other countries in which silkworm genomics is a major component. As part of Indian efforts, DBT has launched a program to develop EST (Expressed Sequence Tags) database on mulberry and non-mulberry silkworm (Muga and tropical Tasar) and also to attempt functional co-relationship of these ESTs with desirable characteristics in silkworm. At IIT Kharagpur and NII, New Delhi, molecular biological studies on silk protein (fibroin and sericin) genes of non-mulberry silkworm have been carried out. Fibroin - a major protein from Eri, Muga and Tasar has been purified and characterized. Work is in progress to clone the whole fibroin gene from tasar silkworms genomic DNA library. A new and novel type of double stranded segmented RNA cytoplasmic polyhedrosis virus infecting tasar silkworm has been identified at IIT, Kharagpur. This will lead scientists to develop control measures against cytoplasmic viral disease affecting tasar silkworm. At CSRTI, eight molecular RFLP (Restriction Fragment Length Polymorphism) markers linked to cocoon shell character have been identified for the first time in the world. Cocoon shell character in silkworm is a primary determinant of the silk yield. The results have opened up prospects for utilizing the identified molecular markers for successful application of directional breeding in silkworm for generating improved races with high silk yield. Mulberry genome mapping: Targeting the host plant, mulberry, a prototype of web enabled DNA database has been developed for the first time in the world encompassing DNA fingerprinting studies carried out on more than 150 genotypes including 48 selected elite genotypes. Efforts have been initiated for construction of framework molecular linkage map of mulberry, which will be helpful in mapping and identification of useful genes in mulberry. At Delhi University the transient expression of a marker gene in various explants from different commercially important genotypes of mulberry have been shown. The first transgenic mulberry plant with marker gene has already been developed. This has opened up possibilities for the production of transgenic mulberry clones with desired traits in the future. Work has been recently initiated for developing transgenic mulberry with drought and salinity tolerance.  Rolly Dureha ]]> <![CDATA[Of lice and human history]]> https://biospectrumindia.com/news/95/2206/of-lice-and-human-history.html https://biospectrumindia.com/news/95/2206/of-lice-and-human-history.html Wed, 09 Mar 2005 17:54:00 +0530 Dr Mark Stoneking Dr Stoneking recently discussed this observation during a presentation on human population history at an international symposium on â€œGenes, Evolution and Complex Disease,â€? at the NCBS in Bangalore.  Using the DNA samples of lice collected from different parts of the world, Dr Stoneking and his co-workers tried to infer when the origin of clothing among humans might have occurred. Lice are obligate parasites and there are two main species of lice- the head louse-Pediculus humanus capitis (which thrives and lays eggs on the scalp) and the body louse-P.humanus corporis, which lives and lays eggs in clothing. Shedding light on some of the findings he said, â€œThe ecological difference between the head louse and body louse came about when clothing became important to humans. Body lice arose around 100,000 years which implies that clothing became important during this time and the population expansion of lice also happened then.â€? He also adds that archaeological evidence such as earliest needles dated back to 40,000 years, thereby almost corroborating the findings. Another discovery was the fact that there is greater diversity in African lice compared to non-African lice.  The cultural angle Dr Stoneking has also studied the diversity of the Y chromosome and mitochondrial DNA (m-DNA) evidence, among Thai hill tribes, which illustrated interesting aspects of human population history. It was found that genetic diversity is more in the Y chromosome. This reflects the differences in migration patterns.  He attributed this phenomenon to patrilocality â€“ a social practice where females move to the residence of their mate after marriage. This means that females have higher migration rate. In case of matrilocal groups, it is the opposite practice. â€œ Within groups, the study showed m-DNA diversity to be lower in matrilocal groups and Y-chromosome diversity to be lower in patrilocal groups.â€? On the other hand, between groups, the m-DNA diversity is greater in matrilocal groups and Y chromosomal divergence is greater for patrilocal groups.  Similarly, among the Hindus, with 2000 castes and five varnas, women were allowed to marry higher castes. â€œThis reflects in the upward mobility of the m-DNA and the limited mobility of the Y-chromosome.â€? Providing a big-picture perspective on the findings, Dr Stoneking said, â€œ It shows that cultural patterns can affect human genetic diversity.â€? The discovery also proves that through out history, women have migrated and moved places more than previously imagined.  Priya Padmanabhan CyberMedia News, Bangalore ]]> <![CDATA[Thermo introduces VarioskanÂ ]]> https://biospectrumindia.com/news/95/1994/thermo-introduces-varioskan-.html https://biospectrumindia.com/news/95/1994/thermo-introduces-varioskan-.html Wed, 09 Mar 2005 17:51:00 +0530 Varioskan, a multimode microplate reader is the latest introduction by Thermo Electron in the range of microplate reading systems. Varioskan is the first multimode microplate-based spectrophotometer and spectroflurometer with a quadrupole monochromator. The new Varioskan spectrofluorometer and spectrophotometer with SkanIt software offers a comprehensive set of easily alterable parameters for optimal assay performance in pharmaceutical and biotech research, assay development and secondary screening. Varioskan provides unlimited assay wavelength selection, an incubator and a dispenser for optimization of kinetic assays, and the utmost sensitivity for fluorometric and photometric applications.  For further details contact: bimal.desai@thermo.com  Mahyco's DesiGen provides quality GM protein testing solutions DesiGen Diagnostics, a division of Mahyco Seeds Ltd., Jalna, Maharashtra, is India's first and the only private company engaged in manufacturing ELISA testing kits and lateral flow assay strips for GM protein detection in plant tissues for Bt proteins Cry1Ac, Cry1Ab and Cry2Ab. Qualitative detection and quantitative estimation of Bt proteins in transgenic plants is critical in GM plant breeding and quality control.  DesiGen has become the leader in manufacturing and supply of GM crop testing kits in the Indian market. It also offers contract sample testing services for qualitative and quantitative analysis of Bt protein. For further details, contact: Dr Bharat Char, e-mail: desigen@mahyco.com SM Bioscience introduces CMOS-based products Israel-based DNR developer and manufacturer of bio-imaging systems for biotechnology research community has come out with CMOS-based products: MiniBIS and MiniBIS Pro. SM Bioscience will introduce these products in India. MiniBIS optics were designed for the research environment and researchers' needs. The MiniBIS system captures electrophoresis images under a wide range of illumination conditions, including UV and white light. With MiniBIS, researchers can store, analyze, and annotate acquired images on their PCs with a variety of popular image analysis software. Direct transfer of images from camera to PC means no loss of resolution - as is common with frame grabber cards that capture data from video signals.  For further details, contact: info@anmalliance.com Millipore's new Steritest EZ device for faster sterility testing Millipore has announced the availability of its Steritest EZ testing device. First in the next generation of Steritest testing tools, the Steritest EZ device provides fast and consistent sterility testing of large volume parenterals and synthetic drugs without antimicrobial activity.  The device's new ergonomically designed needle adapters fit the majority of test containers to maintain a closed concept system, which reduces the risk of adventitious contamination. Pre-installed clamps simplify handling and save time by providing quality control analysts with an easy closing and re-opening mechanism. The longer 850 mm tubing length provides easier set-up and ample room to perform the manipulations involved in sterility testing. In addition, the canister inlet design minimizes foaming for improved reliability and faster filtration.  For more information contact: Ellen_Samuel@milliporeindia.com ]]> <![CDATA[Crystal Gazing intoÂ India Biotech 2010]]> https://biospectrumindia.com/news/95/2270/crystal-gazing-into-india-biotech-2010.html https://biospectrumindia.com/news/95/2270/crystal-gazing-into-india-biotech-2010.html Wed, 09 Mar 2005 17:50:00 +0530 Here is what they came up with when asked to look ahead for Indian biotechnology A new treatment regime The new medical approach to disease management looks at disease as a process rather than a state, where tracking disease progression will allow for better therapy. Gene regulation and other bio-algorithms will form the core of a new wave of diagnostics that are now being referred to as "theranostics." Theranostics are designed to diagnose diseases at their stage of progression to enable the careful and accurate selection of a treatment regimen and to further monitor the patient's response to the said therapy. In short, theranostic tests can determine a patient's response to a specific drug therapy, or guide and assist in choosing the correct and most efficacious treatment regime. Bayer Diagnostics forecasts that the theranostics market will grow by 20 percent per year until 2010. Kiran Mazumdar-Shaw, Biocon Embedded genes Because of its beneficial and sustainable impact on the basic elements of farming, it would not be surprising if biotechnology proves to become the most important agricultural advancement since the first farmer put a seed in the soil. Sekhar Natarajan, Monsanto India Corporate research universities Our universities provide us great students but have become near bereft of research. If we are to survive, this must change soon. One way is for private-public partnerships to create the university of the future. The private sector can run a quality administration for a quality university. Research institutes should establish themselves in this environment. The university will have a research environment and will benefit. The research institute will be stimulated by teaching and by undergraduate and graduate students and will insure itself from rapid decay. And, a small model that shows proof-of-principle will encourage both mimicry and reform. VijayRaghavan, NCBS Cancer, only a zodiac sign President Clinton's transcendental prediction that our children's children may only know Cancer as a Zodiac sign is still a long way from being realized but biotechnology seems to have the tenacity and renewed vigor to make science fiction a reality. I was informed that the general view is that while India is a great place for chemistry, manufacturing and more recently for clinical trials, they are perplexed by what they perceive as a "Biology Hole". The perception is that biologists in India have simply not been trained on the use of these new instruments of biology. It is a bit like asking where our IT industry would be if our software engineers and computer scientists are trained on PC XTs. Vijay Chandru, Strand Genomics Designer crops We should intensify and deepen our efforts in the field of mobilizing the tools of molecular genetics for developing new strains of crops, forest trees, farm animals and fish. The work already done in our country shows great scope for breeding rice and other crops tolerant to salinity and drought as well as for developing vaccines against animal diseases. I hope the 2nd Anniversary of BioSpectrum will mark the beginning of concerted efforts in our country to assess scientifically the risks and benefits associated with genetic engineering and biotechnology. MS Swaminathan, Geneticist Preferred Partner With the changes that are taking place in India, biotech industry will soon merge the separating line between discovery, development and market place. All these can provide a breather to the pharma sector-reduction in the time and cost of making new medicines. This could also reduce time from target identification to launch, boost success rates from first human dose to market and a significant reduction in the pre-launch investment per drug to about $200 million-a cost advantage that Indian industry has been advocating. The current decade is likely to be crucial for biotechnology business. Rajesh Jain, Panacea Biotec Profitable business This mindset has to change. This decade, which is all set to see a biotechnology boom, will belong to those who have the power to convert their dreams into reality. In other words, it will see the rise of the bioentrepreneur. The ones, who will move away from the safe waters of the laboratory and convert a patentable or testable research dream into a viable business proposition. India has the potential to become very strong in biotechnology. There has been a phenomenal increase in the number of start-up companies in this area in the last five years. While the current size of the industry is $700 million, it is expected to grow at 25-30 percent. India ranks third in Asia in patent filings. Krishna M Ella, Bharat Biotech Genetic greenbacks If our administration gears itself to implement the act effectively, it serves two purposes. On one hand, foreign investment would come forth to shake hands with Indian intellect to develop bio-products with far-reaching benefits to the humanity. On the other, this would put an end to mushrooming of biotech companies without expertise or commitment, proliferating at every corner of the street. Once this happens venture capitalists (VCs) would not hesitate to get onto the biotech bandwagon. At a global level, during 2004 VCs have reversed a three-year downward trend by investing $5.6 billion more. Varaprasad Reddy, Shantha Biotechnics India-made novel medicines One can understand intuitively that from 2005 onwards, the number of new molecules, which are under patent to be launched in any calendar year, will not exceed a single digit. Starting with 2-3 new molecules in 2005 and in 2006, it may stabilize to 7-8 new molecules every year after that. Not only that, the molecules eligible for patent, whose application is filed in 1995 onwards, will start going off patent from 2015 onwards. Thus, it is predicted that at any given point of time over the next 25 years, the number of molecules under patent will never exceed even 10 percent of the total molecules being marketed. Also, the patented molecules will always have therapeutic equivalents available. A business report in 2010 may read somewhat like this. "Because of globalization, the world is drinking Colombian coffee, using Japanese cameras, driving American cars, ... and being treated and cured by novel medicines discovered in India." ]]> <![CDATA[Wockhardt launches new insulin delivery devices]]> https://biospectrumindia.com/news/95/1876/wockhardt-launches-new-insulin-delivery-devices.html https://biospectrumindia.com/news/95/1876/wockhardt-launches-new-insulin-delivery-devices.html Wed, 09 Mar 2005 17:48:00 +0530 Wockhardt Ltd has launched automatic insulin delivery devices and cartridges. While the pen device is priced at Rs 1,099, the cartridge will be sold at Rs 169. â€œIt was only 18 months ago since we launched Wosulin, Asia's first recombinant insulin,â€? said Habil Khorakiwala, chairman, Wockhardt Ltd. â€œWosulin made insulin more affordable and helped expand usage among Indian diabetics by 20 percent. We have now developed Wosulin cartridge at our Biotech Park, Aurangabad. Our cartridge and the pen will not only offer great convenience, but will be very affordable too. The patient has to just press an automatic plunger to deliver the insulin just under the skin. Since it is like a normal pen, it can be carried easily and used discreetly.â€?  ]]> <![CDATA[US pressing for lax GM food safety testing: Suman Sahai]]> https://biospectrumindia.com/news/95/2529/us-pressing-for-lax-gm-food-safety-testing-suman-sahai.html https://biospectrumindia.com/news/95/2529/us-pressing-for-lax-gm-food-safety-testing-suman-sahai.html Wed, 09 Mar 2005 17:46:00 +0530 Gene Campaign, The German Church Development Service and the Institute for Agriculture and Trade Policy, USA, have registered their protest with the US FDA against the new guidelines being proposed to test the safety of genetically engineered foods. According to Dr Suman Sahai of Gene Campaign "This is a nightmare for the developing countries where the regulatory system is weak and ineffective. Further, laxity with respect to food safety would enable companies to escape liability for their actions and not be accountable for contamination of the food supply." ]]> <![CDATA[US executive life science mission visits India]]> https://biospectrumindia.com/news/95/2412/us-executive-life-science-mission-visits-india.html https://biospectrumindia.com/news/95/2412/us-executive-life-science-mission-visits-india.html Wed, 09 Mar 2005 17:45:00 +0530 The US-India Business Council's first annual executive life sciences mission, led by C Nigel Thompson, executive director, economic and development strategy, Merck & Co. participated in the Biotech India 2005 show. The Mission included senior representatives from the Biotechnology Industry Organization (BIO), the Chatterjee Group, Dow Chemical Company and Vickery International. Summarizing the mission's objectives, Thompson said, "Our priority for this Mission is to continue to build the private sector and academic connections that will lead to a dramatic increase in the US-India life sciences collaboration in 2005-06." ]]> <![CDATA[Suven to do phase IV trials for US firm]]> https://biospectrumindia.com/news/95/2753/suven-to-do-phase-iv-trials-for-us-firm.html https://biospectrumindia.com/news/95/2753/suven-to-do-phase-iv-trials-for-us-firm.html Wed, 09 Mar 2005 17:44:00 +0530 Suven Life Sciences has signed a contract with United Therapeutics Corp., USA, for conduct of Phase IV clinical trials on United's product in India. The initial contract is valued at $2.5 million and the 15-months study would be conducted in over 30 institutions in India. ]]> <![CDATA[Shantha Biotechnics launches DNA EPO]]> https://biospectrumindia.com/news/95/1755/shantha-biotechnics-launches-dna-epo.html https://biospectrumindia.com/news/95/1755/shantha-biotechnics-launches-dna-epo.html Wed, 09 Mar 2005 17:42:00 +0530 Shantha Biotechnics, a pioneer in modern biotech health care products in India, announced the launch of its fourth r-DNA product, Shanpoietin. A recombinant DNA Erythropoietin [EPO] in prefilled syringe, Shanpoietin is based on its indigenously developed serum-free culture technology. â€œThe technology behind Shanpoietin is unique,â€? observed Varaprasad Reddy, managing director, Shantha Biotechnics. â€œThe Gene for Erythropoietin has been cloned in Chinese hamster ovary [CHO] expression vector and expressed extracellularly. It is the only technology of its kind in India where the CHO cells have been adapted to serum free media and grown in fermenters. This process is far superior to competitor's technology where the cells are seeded in roller bottles in the presence of serum.â€? Erythropoietin products are mostly imported in India and account for almost 70 percent share of the current market size of Rs 75 crore.  ]]> <![CDATA[Preventive AIDS vaccine trial begins in PuneÂ ]]> https://biospectrumindia.com/news/95/2116/preventive-aids-vaccine-trial-begins-in-pune-.html https://biospectrumindia.com/news/95/2116/preventive-aids-vaccine-trial-begins-in-pune-.html Wed, 09 Mar 2005 17:41:00 +0530 Dr NK Ganguly, director general, ICMR The first human clinical trial of an investigational vaccine candidate in India designed to prevent HIV/AIDS began in Pune. The trial is being conducted at Indian Council of Medical Research (ICMR)'s National AIDS Research Institute (NARI) in Pune, and is testing a vaccine candidate named tgAAC09 (recombinant adeno-associated viral vector, rAAV). Targeted Genetics Corp., a Seattle-based biotechnology company, and Columbus Children's Research Institute (CCRI) in Ohio designed the vaccine candidate in partnership with International AIDS Vaccine Initiative (IAVI).  The trial is being conducted by a partnership between the Government of India through the ICMR and the National AIDS Control Organization (NACO) and the not-for-profit IAVI. The trial in India is part of a multi-country Phase-I trial of tgAAC09 that is also underway in Europe; researchers in Germany and Belgium are testing the vaccine candidate in partnership with IAVI.  Announcing the trial, the union minister of health and family welfare, Dr Anbumani Ramadoss, said, â€œDeveloping a vaccine to prevent AIDS is one of the most difficult scientific challenges of our time.â€? IAVI board member and minister for science and technology, Kapil Sibal said, â€œVaccine research is so critical that the health and the science and technology ministries have joined hands to provide the effort the support it needs.â€? Sibal called for greater commitment from developed countries for HIV-AIDS vaccine research. He said a G-20 type forum is required urgently to give a boost to such research. According to Dr NK Ganguly, director general, ICMR, â€œWith this first trial, Indian scientists are making an important contribution that will bring the world a step closer to an AIDS vaccine.â€? Dr SY Quraishi, director general, NACO said, â€œThe trial initiation is a great culmination of the tripartite partnership among ICMR, NACO, and IAVI. We expect to test other vaccine candidates in the coming years under this partnership.â€?  ]]> <![CDATA[Orissa to set up biotech park in BhubaneswarÂ ]]> https://biospectrumindia.com/news/95/1650/orissa-to-set-up-biotech-park-in-bhubaneswar-.html https://biospectrumindia.com/news/95/1650/orissa-to-set-up-biotech-park-in-bhubaneswar-.html Wed, 09 Mar 2005 17:40:00 +0530 Orissa plans to set up a 150-acre biotech park in Bhubaneswar to help the government and non-government biotech firms to set up their units, according to the draft paper distributed by the government in the conference to discuss the scope and development of biotechnology in the state. Naveen Patnaik, chief minister of the state, released the state's draft Biotech policy 2005 at a three-day workshop â€œbiotechnology-potentials for development in Orissaâ€?. Other parks in the pipeline include a marine biotech park at Chilika, pharma-biotech park at Bolangir-Bargarh, medicinal plant and R&D and processing units at Baripada and Jeypore in Koraput and Sambalpur. Besides, the state also plans to set up a forest biotechnology park at Manamunda in the district of Kandhamal based on the availability of government land. The park in Bhubaneswar would be built as a JV project with private promoters who will contribute the equity of the project and will be responsible for designing, constructing, financing, marketing and maintaining the park. CyberMedia News  ]]> <![CDATA[Norway seeks biotech partnerships with IndiaÂ ]]> https://biospectrumindia.com/news/95/1369/norway-seeks-biotech-partnerships-with-india-.html https://biospectrumindia.com/news/95/1369/norway-seeks-biotech-partnerships-with-india-.html Wed, 09 Mar 2005 17:39:00 +0530 A Norwegian business delegation led by the country's minister for trade and industry, Borge Brende, was in Bangalore to forge better ties with India in areas related to marine biotechnology and aquaculture. Addressing an Association of Biotechnology Led Enterprises (ABLE) symposium titled â€œIndia and Norway: Finding solutions together,â€? Brende said that he believed that like IT, India had the potential to become a leader in the biotechnology arena. â€œIndia has impressively developed its agriculture sector and is now in the process of transforming its food industry. I look forward to promote cooperation between Norway and India in biotech and food safety,â€? he added. He also informed that Karnataka minister of state for agriculture Srinivasa Gowda had expressed interest in capacity building in fisheries, marine biotechnology and aquaculture. The Karnataka government plans to develop a marine biotechnology and aquaculture research center and park in Uttara Kannada district of the state. A trade delegation of 40 Norwegian companies representing various sectors accompanied the minister on his visit to India. Brende stated that the current volume of trade between the countries was around $300 million in 2004, which is expected to grow by 44 percent this year.  CyberMedia News  ]]> <![CDATA[New facility at ICGEB]]> https://biospectrumindia.com/news/95/1962/new-facility-at-icgeb.html https://biospectrumindia.com/news/95/1962/new-facility-at-icgeb.html Wed, 09 Mar 2005 17:37:00 +0530 Kapil Sibal, minister for science and technology, inaugurated the extended laboratory facility at the International Centre for Genetic Engineering and Biotechnology (ICGEB) for vaccine research. Carlo Azeglio Ciampi, President of Italy and Letiza Brichetto Arnaboldi Moratti, minister of education, universities and scientific research, Italy were also present on the occasion. Research on dengue and tuberculosis vaccines and diagnostics will be carried out in the new facility. It has working space for about 50 researchers including six principal investigators. Further, "A national facility for TB animal challenge with P4 biosafety level will come up by early next year at the ICGEB campus with the support of the DBT. This is the need of the hour as in spite of 30-40 researchers working on TB in India, a quality-challenge facility to evaluate the efficacy of the vaccines for TB does not exist," said Dr VS Chauhan, director, New Delhi component, ICGEB. ]]> <![CDATA[Kakinada to have a bio-diesel plant]]> https://biospectrumindia.com/news/95/2929/kakinada-to-have-a-bio-diesel-plant.html https://biospectrumindia.com/news/95/2929/kakinada-to-have-a-bio-diesel-plant.html Wed, 09 Mar 2005 17:37:00 +0530 Naturol Bio-Energy will set up a 300 TPD integrated bio-diesel plant in Kakinada Special Economic Zone (KSEZ). The plant will be set up at an estimated cost of Rs 139.50 crore by Naturol Bio-Energy India in a JV with Energea GmbH, Austria. KSEZ is a port based special economic zone project in Kakinada promoted by Kakinada Sea Ports Ltd, ONGC and IL&FS. "We are pleased to sign the MoU with Kakinada SEZ. SEZ will make the implementation process more efficient and timely as SEZ will grow to become a fully developed operating port that will have solid infrastructure facilities to support our integrated bio-diesel project," Bhaskar Chalasani, managing director, Naturol Bio- Energy said. ]]> <![CDATA[G Biosciences to launch ducational programs]]> https://biospectrumindia.com/news/95/1316/g-biosciences-to-launch-ducational-programs.html https://biospectrumindia.com/news/95/1316/g-biosciences-to-launch-ducational-programs.html Wed, 09 Mar 2005 17:34:00 +0530 G Biosciences, a proteomic-products player, will launch international standard biotechnology workshops and training programs, BioScience Excellence, in India. "Our objective has been to design and develop kits for practical understanding of genes, proteins and their relationship in living cells," said Dr Aftab Alam, CEO, G Biosciences. "The program will be launched in India in April 2005 with the registrations starting in March. Each batch can accommodate about 60 students," Alam added. ]]> <![CDATA[Dendrite introduces India-specific pharma solution]]> https://biospectrumindia.com/news/95/2801/dendrite-introduces-india-specific-pharma-solution.html https://biospectrumindia.com/news/95/2801/dendrite-introduces-india-specific-pharma-solution.html Wed, 09 Mar 2005 17:28:00 +0530 US-based Dendrite International is introducing its web enabled sales force solution exclusively designed for Indian pharmaceutical industry. The company hopes that the product "Mobile Intelligence", which was developed after discussions with Indian pharma majors, would enhance the efficiency of medical representatives and other sales personnel in the industry. This product has been designed at the company's technology resource center in Bangalore. The company's senior VP and CTO Garry Johnson said, "The Indian market offers a lot of opportunity for us since there is no other similar product that is available in the market." Dendrite International's director Marc Kustoff said that the price point was consistent with the Indian market. "While we follow a licensing model in other countries, here we follow a rental pricing model," he added.- CyberMedia News ]]> <![CDATA[CII inks MoU with Canadian research council]]> https://biospectrumindia.com/news/95/2787/cii-inks-mou-with-canadian-research-council.html https://biospectrumindia.com/news/95/2787/cii-inks-mou-with-canadian-research-council.html Wed, 09 Mar 2005 17:26:00 +0530 The Confederation of Indian Industry (CII) and the National Research Council (NRC) of Canada signed an MoU to support the Small and Medium Enterprises (SME) in India and Canada. The MoU was signed coinciding with the 16th IETF, organized by CII. N Srinivasan, director general, CII, said, "The objective of the MoU is to promote and facilitate the development of technology-based joint ventures or strategic alliances between SMEs from Canada and India." ]]> <![CDATA[Cancer Genetics launches Indian venture]]> https://biospectrumindia.com/news/95/2223/cancer-genetics-launches-indian-venture.html https://biospectrumindia.com/news/95/2223/cancer-genetics-launches-indian-venture.html Wed, 09 Mar 2005 17:24:00 +0530 Ramesh Shah, Dr Raju SK Chaganti and Peter Hartmayer launch Genetics. Cancer Genetics India, an innovative developer of genetic diagnostic probes, has set up Genetics Specialties P Ltd in Bangalore. Dr Raju SK Chaganti, founder and chairman of the board of directors of Cancer Genetics Inc. said, â€œGenetics will introduce a range of genetic diagnostic and prognostic probes in India.â€?  Cancer Genetics is known for its Fluorescence In Situ Hybridization (FISH) probes that are used to detect cancer cells, and it internationally markets 48 of them. Cancer Genetics will hold a 51 per cent stake in the Bangalore company, headed by Ramesh Shah. According to Peter Hartmayer, executive vice president, marketing and sales, Cancer Genetics, the FISH probe market alone in India is valued at $1.6 million and is growing at 58 percent annually. The worldwide market of it is $130 million.  Genetics Specialties will launch 150 new probes in the Indian market. About 52 of the probes would be for cancer diagnosis alone. The average price of the probes will be Rs 2,500-3,000 per test and it expects to capture a 20-25 percent market share of the Indian market over the next two years.  ]]> <![CDATA[Amity, Mascon tie up]]> https://biospectrumindia.com/news/95/2579/amity-mascon-tie-up.html https://biospectrumindia.com/news/95/2579/amity-mascon-tie-up.html Wed, 09 Mar 2005 16:55:00 +0530 Amity Institute of Biotechnology (AIB) and Mascon Global Ltd have tied up to promote research and development in bioinformatics. They would jointly undertake product development projects, particularly in sequence analysis, comparative genomics, proteomics and molecular modeling. Dr Sunil Saran, director, AIB and Dr AP Agnihotri, senior partner, Mason, signed an agreement to this effect. ]]> <![CDATA[CII show discusses on biotech reach]]> https://biospectrumindia.com/news/95/1456/cii-show-discusses-on-biotech-reach.html https://biospectrumindia.com/news/95/1456/cii-show-discusses-on-biotech-reach.html Wed, 09 Mar 2005 16:40:00 +0530 The Biotech India 2005 tradeshow and conference, part of the 16th International Engineering & Tech nology Fair (ITEF) 2005, saw the gathering of top industry leaders, academicians, foreign delegates from the global biotechnology industry. The event was organized by the Confederation of Indian Industry (CII).  Dr MK Bhan, secretary, Department of Biotechnology was the chairperson for the event. In his keynote address during the inauguration of the conference, he elaborated on the forthcoming national biotechnology policy. He said: â€œThe ultimate goal of the government is to move towards a single regulatory authority, where all composites of the sector would be brought under one structure. The aim is to make decision making faster and pro-active, thereby making it more professional and a solid structureâ€?.  Dr Bhan further stated that all the simplifications concerning the biotech sector, suggested by the Mashelkar Committee and the Prof M S Swaminathan Committee, would be introduced in the new policy. He said that innovative mindset should be promoted in the country and the drive to promote innovation has to come from the industry. â€œThere is a need to create a clear framework for public-private partnership and public investment in that component should be increased, without making a distinction between public institution and private institution,â€? he added. Prof Malik Peiris, professor of Microbiology at the University of Hong Kong, who discovered the SARS virus, spoke on â€œConfronting emerging infections: lessons from SARS and Avian Fluâ€?. He stressed on the urgent need to develop a flu vaccine as avian flu has the potential to become a human pandemic creating havoc in the South East Asian region. He said: â€œIn the present context, one should not forget the classical technology as the world embraced new technology. There was a need for closely integrating bedside clinical medicine/epidemiology and laboratory medicine, besides a need for indigenous biotech base to capitalize on research gainsâ€?. Dr Swati Piramal, co-chairperson, CII National Committee on Biotechnology and director-Strategic Alliances and Communications, Nicholas Piramal India, in her welcome address, said that there has been an inflection point in India and the point was January 1, 2005, when India became TRIPS compliant. According to Dr Piramal, post January 1, the color of the new landscape would be different from what it was in the past. She hoped that the new regime would pave the way for more alliances, which would add value across the pharmaceutical chain. Prof Inder Verma, Laboratory of Genetics, The Salk Institute, La Jolla, USA, also addressed the inaugural session and made a presentation on â€œFrom an idea to an IPO: An academic's perspectiveâ€? based on his rich experiences in the biotech industry. One of the highlights of the event was an exclusive roundtable discussion on â€œNational Biotechnology Policy - Leveraging Emerging Opportunities in Biotechâ€?. During the discussion Dr Vijay Chandru, chairman and CEO, Strand Genomics, said that the three areas that need to be addressed on priority were the need for a good core facility for high-end biotech research for both the public and private sector; experimentation in academic entrepreneurship; and our potential in chemistry should be explored. Khalil Ahmed, executive director, Shantha Biotechnics opined that for the growth of the industry one has to let go slowly of the past. Hari S Bhartia, co-chairman and managing director of Jubilant Organosys said that risking money for research was the key challenge.  Aseem K Chauhan, trustee and board member, Amity institutions, stated that promoting entrepreneurship and India specific niche areas is important. Dr Swati Piramal stressed that better regulatory reforms were the need of the hour with special legal courts. Dr M Vidyasagar, EVP (Advanced Technology), TCS, was of the view that more clarity was needed on IPR and a proper road map was required. Ending the discussion, Dr Bhan said that the biotech policy would be promoting innovation, removing roadblocks, filling in gaps in niche areas and creating a dialogue across disciplines. â€œFor the overall growth of the sector a flow of money from all sections is required so that we do not exhaust ourselves outâ€?, he stated.  The conference deliberations saw distinguished experts from leading companies and organizations like Merck, Guava Technologies, Dow Chemical Company, Sequenom, National Defense University of USA and BIO speak on the different aspects of the business and science of biotechnology viz: venture capital for biotech; emerging research tools and technologies; managing a biotech business; maximizing value through global partnerships, among others. The event had a strong participation from research institutions like ICGEB, CCMB, JNU, NII, Delhi University, etc. Dr William Haseltine, chairman and chief executive, Haseltine Associates Limited (formerly CEO, Human Genome Sciences) gave the valedictory address on â€œA Central Role of for India in The Biopharmaceutical Industry-Today and Tomorrowâ€?. He said, â€œIndia has a well trained and educated workforce which is its biggest resource. It has the depth of knowledge of many fields, leading chemical manufacturers and access to adequate cohorts of human population for clinical trials. What it needs to develop is a robust, strong world class infrastructure for clinical development, which will enable it to become a world leader in pharma exports in the next 20 yearsâ€?. The one-and-a-half day biotechnology conference primarily focused on forging global partnerships, frontier technologies, technology transfer between scientists and entrepreneurs, venture capital funding and how the emerging opportunities could be tapped to India's advantage. Speakers from five state governments - Delhi, Haryana, Karnataka, Tamil Nadu and Uttar Pradesh used this opportunity to showcase their state's potential in this area Rolly Dureha ]]> <![CDATA[BioAsia 2005 peps up Genome Valley]]> https://biospectrumindia.com/news/95/2537/bioasia-2005-peps-up-genome-valley.html https://biospectrumindia.com/news/95/2537/bioasia-2005-peps-up-genome-valley.html Wed, 09 Mar 2005 16:36:00 +0530 The secondedition of the three-day pan-Asia biotechnology conference held from February 10-12 in Hyderabad ended on a positive note with the signing of 27 MoUs, underlining the fact that there is tremendous potential for countries to initiate joint research and development activities and simultaneously establish effective trading links to expand operations.  Chief Minister YS Rajasekhara Reddy (Right) with Dr Anwar Nasim, president, FABA at BioAsia 2005. According to Dr Ashok K Sadhukhan, coordinator of B2B Forum and vice chairman, All India Biotech Association (AIBA), Southern Chapter, 72 one-to-one meetings were arranged during the event. Over 40 delegates, comprising both company representatives and individual entrepreneurs, from over 30 countries participated in the forum. Collaborations were sought in the areas of vaccines, biopharmaceuticals, diagnostic products, pharma chemistry and product development, agri-biotech, contract research, business development and outsourcing, and venture financing. AIBA was given the responsibility to arrange this forum. At the end of the event, a total of 27 accords were signed compared to 21 in 2004.  Public-private partnership important: Dr MK Bhan, secretary, Department of Biotechnology (DBT), who was the chief guest for BioAsia 2005, set the tone for the event calling for public-private partnership and funding. Dr Bhan stated: â€œIssues in the areas of intellectual property, science-based regulation, and strategy in the area of innovation are essential for the sector to prosper.â€? The department is keen on simplification of the regulatory processes and within the next three months a national biotech policy would be unveiled, Dr Bhan pointed out. â€œThe ordinance on the intellectual property rights has already been passed and the law in this regard is expected soon,â€? he said. He was of the view that the regulatory and policy framework should inspire and motivate the industry to focus on discovery and innovation. â€œThe objective of the policy or strategies is to make this whole area innovative. The industry on its part should capitalize on the opportunities to create new ideas and concepts through R&D,â€? Dr Bhan said. Biotech promotion strategy: Andhra Pradesh, which is one of the first states in India to have adopted a holistic approach to promote biotechnology, is strengthening its biotech base further. â€œThe state government has evolved a three-pronged strategy to promote biotechnology. These include creation of world-class infrastructure, promotion of institutions to support bio-ecosystem and provision of investment-friendly operating environment for industries,â€? stated the chief minister, Dr YS Rajasekhara Reddy.  On the Sidelines Manipal Acunova to set up stem cell research center Bangalore-based custom research and clinical trial company, Manipal Acunova, is mulling to set up an alliance development center in Los Angeles, US, with an earmarked investment of $1 million. It will also set up a stem cell research lab in Bangalore designed by Zanders of Germany.  German firm to set up diagnostic lab in Hyderabad Germany-based AgeLab Pharma is planning to set up three diagnostic laboratories of which at least one of them would come up in Hyderabad with an estimated investment of about Euro 2 million. Confirming this AgeLab Pharma, managing director, Dr Amal K Mukhopadhyay said, â€œWe are looking at franchisees and tie-ups with consultancy service firms.â€?  Altana Pharma to set up R&D center in Mumbai Focusing on medicinal chemistry, German-based Altana Pharma has decided to set up its own R&D center in India earmarking investments of around Euro 9.8 million. The company has also acquired 10,000 sq. mt. of land for the proposed center in Andheri, Mumbai. Altana Pharma, MD, Dr Volkar Figala, said, â€œThe construction activities would begin in the second half of this year and we will begin recruiting scientists for the facility by June.â€?  Addressing a gathering of industrialists, scientists, academicians and policymakers at BioAsia-2005, Dr Reddy said the government would continue to play its role as a facilitator and a trusted partner of the industry in the path of enterprise and innovation. The chief minister said while entrepreneurs could set up their R&D facilities at the ICICI Knowledge Park, they could establish production facilities at the Shapoorji Pallonji (SP) Biotech Park.  Over 17 companies have taken space in SP Biotech Park and over 75 percent of the phase-I and 50 percent of the phase-II has already been sold out. And it will move to the third phase. â€œThe state government has identified an additional 1,000 acres of land in the Genome Valley, on the outskirts of the city. Besides, an additional 200 acres of land for the Marine Biotech Park in Visakhapatnam is also on the anvilâ€? said KV Rao, principal secretary, industries and commerce department, Andhra Pradesh.  National animal resource facility: NK Ganguli, director general, Indian Council of Medical Research (ICMR), informed that the project report for the National Animal Resource facility is ready and is under consideration. â€œThe first impression of the project report shows that the proposed facility is better than the existing animal breeding facility in Mumbai,â€? he stated. DBT has already approved Rs 20 crore and raising capital for the project was not a constraint. â€œThe plan for building the facility should be in place in the next 6-8 months and it would run on a corporate philosophy,â€? he added. Ganguli also said that the National Institute of Nutrition's small animal house is also getting updated and the plans and tenders were through.  FABA launched: Another important development during the event was the launch of the Federation of Asian Biotech Association (FABA). Announcing the official launch, along with the release of the logo and the memorandum of articles, Dr Anwar Nasim, chairman, National Commission of Biotechnology, Pakistan and president, FABA, said, â€œThis organization was formed by the eight-member countries consisting of India, Iran, Pakistan, Singapore, Germany, Sri Lanka, Israel, and Philippines. Besides developing biotech activities, FABA would establish just and equitable principles of participation and practice among member countries.â€? The organization started with eight member countries and its secretariat is located in Hyderabad. â€œWe would now be taking this concept to as many countries as we can in the Asian region, so that there would be economic development tagging along,â€? added Nasim.  William A Haseltine, chairman and chief executive officer of Haseltine Associates Limited, a US based biotechnology consulting firm, was conferred the â€œGenome Valley Excellence Awardâ€? at BioAsia 2005. The state is keen to step up the momentum post the biotech event. It is considering the option of having a separate department for biotech. The message seems very clear. It wants to be a leader in the space of biotechnology and establish a successful model for biotech promotion and development.  Ch. Srinivas Rao and Sunitha Natti in Hyderabad ]]> <![CDATA[Happy Tidings]]> https://biospectrumindia.com/news/95/1037/happy-tidings.html https://biospectrumindia.com/news/95/1037/happy-tidings.html Wed, 09 Mar 2005 16:35:00 +0530 Suresh N My inaugural edit launching BioSpectrum in March 2003 was titled, â€œJoining The Mainstream.â€? After Palaniappan Chidambaram's latest Union budget, I could confidently say that biotechnology has indeed joined the mainstream of Indian economy. The finance minister, reflecting Prime Minister Dr Manmohan Singh's views, has termed biotech, along with pharma as the â€œsunriseâ€? sector and offered many incentives and showered goodies to make it a more happening industry. In fact, in the budget speech, biotechnology has been mentioned specifically more times than software or information technology. In fact, going out of the way, Chidambaram said: â€œIn biotechnology, the industry has the potential to be a global leader supplying novel technologies and products to the health and agriculture sectors. The government will provide a stable policy environment and necessary incentives to help the two industries (biotech and pharma) become world leaders.â€? Could the industry have asked for more at this juncture? In the last issue, BioSpectrum had proposed a biotech agenda for Mr Chidambaram. And his response through the budget speech is in the following pages in the report, â€œChidambaram's BioBudget Thrills Industry.â€?  Two years is not a very long time in the life of a fledgling magazine. But these years have gone by very fast, even as we try to keep up with the frenetic pace of allround growth in the biotechnology business. The BioSpectrum team has learnt a lot from interacting with the industry leaders and the readers. Incorporating most of these suggestions, the magazine has been redesigned to give it the look and feel of an international business publication.  This occasion of the second anniversary has also come in handy to make the industry leaders to look into the future and visualize the industry's status in 2010. Leading the list of dozen Guest Columnists in this issue is the Prime Minister himself. In this special article, he has spelt out his government's agenda for biotechnology and other technology sectors. He has clearly singled out biotechnology as one of the sectors for priority in public policy and the results of these actions are likely be felt in the next few years. Since assuming charge in May 2004 as the Minister for Science & Technology, Kapil Sibal has focused a lot attention to put biotech on a growth path along with DBT Secretary Dr M K Bhan, who also completed an action-packed first year in office on March 1. In between coordinating setting up the country's tsunami warning network and visiting India's farthest scientific stations in the frozen continent of Antarctica, Sibal outlined his priorities for the biotechnology sector in an exclusive interview with BioSpectrum. BioSpectrum was launched with the aim to become the most natural forum for exchange of all views and informed debate about the needs and deeds of the biotech industry for decades to come. In the last 24 months, the magazine has tried to live up to its mandate with a pro-active approach to highlighting industry issues, create a forum for lively discussions on key topics and act as the most highly sought-after source for information on Indian biotechnology. The journey has only begun. Together, I am sure, we all can create an everlasting industry to benefit millions of our citizen who desperately need the fruits of this technology. <sureshn@cybermedia.co.in> ]]> <![CDATA[Become Quality Leaders]]> https://biospectrumindia.com/news/95/2642/become-quality-leaders.html https://biospectrumindia.com/news/95/2642/become-quality-leaders.html Wed, 09 Mar 2005 16:31:00 +0530 K Varaprasad Reddy  Managing Director,  Shantha Biotechnics, Hyderabad The year 2005 began on a hopeful note for the biotech industry. The Indian government through Padma awards, has demonstrated to the world how much it cares for the life sciences sector. Hope the Finance Minister too gives equal importance and offers enough incentives in the budget to boost R&D and to attract VCs. The year 2005 is also significant as we have to learn to live under the new product patent regime. By promulgating the required ordinance in December 2004, the government has complied with TRIPS obligations and is expecting the industry to follow suit. Indian pharmaceutical companies are gearing up to the WTO regime and are adopting a strategy of R&D-based innovative growth by spending more and more funds on R&D, which never happened earlier.This year their investment in R&D might increase further and if this trend continues, soon they might even meet the international norm of 12 per cent. As minister for science and technology, Kapil Sibal has rightly pointed out, we have to revamp and upgrade our legal infrastructure also to fight patent suits lest our Indian companies lose on that count.  If our administration gears itself to implement the Act effectively, it serves two purposes. On one hand, foreign investment would come forth to join hands with Indian intellect to develop bio-products which will have far-reaching benefits to humanity. On the other, this would put an end to mushrooming of biotech companies without expertise or commitment, proliferating at every corner of the street.  Once this happens venture capitalists (VCs) would not hesitate to get onto the biotech bandwagon. At a global level, during 2004 VCs have reversed a three-year downward trend by investing $5.6 billion more. This year might see them investing more and more in biotech. In India, bio-agri industry is growing fast. Biotech crop area in India has increased four-fold during 2004 and this might be another good area for investment.  We badly need quality controlling mechanisms and institutions to earn repute at global level. A lot more bio products should try to get WHO pre-qualification. During the recently concluded BioAsia 2005 conference in Hyderabad, the organizers have declared signing of nearly 15 MoUs between member countries. It remains to be seen how many of them will see the light of the day.  As far as Shantha Biotech is concerned, the year 2005 is very important for us. We have already launched Shanpoietin (r-DNA Erythropoietin). Combo Vaccines and GCSF are expected to follow. A large facility with an area of 100,00 sq. ft. is taking shape to develop and manufacture viral vaccines for measles, mumps, rubella and is expected to be completed early next year. Nearly 15 biotech products are in various stages of development and some of them â€“ at least three of them - might enter the market during 2005. We are going to consolidate our position in vaccine market with our combination vaccines, expected to be launched in March 2005. Still a lot more has to be done. As one of the speakers pointed out at BioAsia conference, no new vaccine had been developed in Third World countries so far. Let us hope the year 2005 augurs well to turn that dream into reality. ]]> <![CDATA[From virtual BT to reality biotech]]> https://biospectrumindia.com/news/95/3846/from-virtual-bt-to-reality-biotech.html https://biospectrumindia.com/news/95/3846/from-virtual-bt-to-reality-biotech.html Wed, 09 Mar 2005 16:30:00 +0530 Dr K VijayRaghavan Director, National Center for Biological Sciences (NCBS),  Bangalore.  Biotechnology - although an all-encompassing term - has come of age in India, both in academia and in industry. By this, I do not necessarily mean that it is successful. I just mean that it has got to the point where it has to sink or swim on the basis of its content and not because of the goodwill it has. This is not to say that the government should not offer any special encouragement or support, quite the contrary. But, it is time that we set the highest standards of performance and accountability.  India is fortunate that several cities can boast of at least a few high quality biotech industries and academic institutes. This is true of Pune, Delhi, Mumbai, Hyderabad and Bangalore. A country like ours needs ten times more quality industry and quality academic research.  How does one reach these goals? The simple way is to develop and demonstrate a model that can stimulate entrepreneurship and academic research and then, if it is successful, others will imitate it. And, there is no harm in starting small as long it is started well. We need a virtual institute of biotech entrepreneurship with its feet deep in the real world.  Here's what we can do: We need at least one short course each year by 3-4 top scientists turned successful entrepreneurs along with their CEOs, and their venture investors on how the company was started, their trials and tribulations and how they learnt swimming in the deep-end of the pool (i.e. the real- world)?  This course should be held in an academic institute. It will be wonderful if the course breeds biotech industrialists. But, even if it becomes just a talking shop for industry-academia interactions much value can come of it if there is one in each city. With luck, NCBS may well start such a course later this year. Stimulating industry is easy compared to stimulating academia.  Our universities provide us great students but have become near-bereft of research. If we are to survive, this must change soon. Many 'solutions' have been mooted for this. One way is for private-public partnerships to create the university of the future. The private sector can run a quality administration for a quality university. Research institutes should establish themselves in this environment. The university will have a research environment and will benefit. The research institute will be stimulated by teaching and by undergraduate and graduate students and will insure itself from rapid decay. And, a small model that shows proof-of-principle will encourage both mimicry and reform. Any takers? ]]> <![CDATA[Towards a Hunger-free India]]> https://biospectrumindia.com/news/95/1002/towards-a-hunger-free-india.html https://biospectrumindia.com/news/95/1002/towards-a-hunger-free-india.html Wed, 09 Mar 2005 16:25:00 +0530 Prof M S Swaminathan  Chairman, National Commission on Farmers, Govt. of India UNESCO Cousteau Chair in Ecotechnology Chairman, M S Swaminathan Research Foundation On the midnight of August 14-15, 1947, Jawaharlal Nehru referred to a new dawn in our history and our entering into a tryst with destiny. Being aware that widespread poverty in the country has its roots in agricultural stagnation, Nehru remarked, â€œeverything else can wait, but not agricultureâ€?. This led to several policy and program initiatives such as enlarging the area under assured irrigation, producing the inputs needed by farmers such as seeds, fertilizer, pesticides, and farm implements, and above all, strengthening our infrastructure in the field of agricultural research and education. Thanks to these far-sighted steps, we have today a National Agricultural Research System of which we can be proud. On the midnight of August 14-15, 1997, K R Narayanan, the then President of India, referred to two major achievements of the first 50 years of our Independence. These are: first, our democratic system of governance extending up to the village level leading to the recognition that India represents the world's largest functioning democracy and second, the achievement of our farmers, scientists and policy makers in making the country self reliant in food production. In spite of striking agricultural progress and democratic decentralization, poverty and poverty-induced under-and malnutrition are widespread. International and national media refer to this situation as the co-existence of â€œgrain mountains and hungry millionsâ€?. What should we regard as our major achievement when we commemorate the 60th anniversary of our Independence on the midnight of 14-15 August 2007? Obviously, it should be the ending of the unnecessary and unenviable reputation of India being the home of the largest number of under-fed children, women and men. We can achieve this goal through a three-pronged strategy. First, we should introduce an open-ended Food Guarantee Scheme on 15 August 2007, combining the features of the Food for Work and Employment Guarantee Schemes. Second, we should help our farm and fisher families to enhance the productivity, profitability and sustainability of major farming systems through mutually reinforcing packages of pro-poor technologies, services and public policies. Third, we should enlarge opportunities for self-help groups, and other forms of group associations to take to market-driven non-farm enterprises, thereby accelerating livelihood opportunities in the rural non-farm sector. All this will call for steps which can help us to mobilize concurrently scientific progress represented by the on-going biotechnology, digital, space and other technological revolutions and the social revolution represented by the 11th schedule of the Constitution 73rd Amendment Act relating to Panchayati Raj. We should intensify and deepen our efforts in the field of mobilizing the tools of molecular genetics for developing new strains of crops, forest trees, farm animals and fish. It imperative that we should incorporate in the crops cultivated along the coast, genes for resistance to abiotic stresses. I hope the 2nd Anniversary of BioSpectrum will mark the beginning of concerted efforts in our country to assess scientifically the risks and benefits associated with genetic engineering and biotechnology, so that our farm families are able to derive the maximum benefit from the new genetics. ]]> <![CDATA[The Promise of Crop Biotech]]> https://biospectrumindia.com/news/95/2142/the-promise-of-crop-biotech.html https://biospectrumindia.com/news/95/2142/the-promise-of-crop-biotech.html Wed, 09 Mar 2005 16:20:00 +0530 Sekhar Natarajan  Managing Director, Monsanto India Ltd The first conscious effort at biotechnology in agriculture is attributed to the 18th century Austrian monk, Gregor Mendel, who systematically cross-bred sweet peas. Since then, hybridization and controlled cross-cultivation have led to consistent improvements in the yield and nutritional content of crops. When Francis Crick and James Watson discovered DNA in 1953; we gained the capacity to cross-cultivate with a greater degree of precision. Rather than the mate-and-wait methods of conventional plant cultivation, crop biotechnology allows plant breeders to develop crop varieties more suitable for diverse growing locations. Yet, in a 1998 survey gauging public sentiment towards biotech derived food, when respondents were asked the question: â€œDo you currently consume any foods that contain DNA?â€?. Two thirds confidently answered 'No'. Yet ever since humans moved away from hunter-gatherer subsistence, genetic modification has been a fact of life in food production. Similarly, urea, now near indispensable in agriculture, was viewed with suspicion in the 1960s when organic manure ruled the roost. Motorized equipment replaced horses and manual labor so more acres could be cultivated. Hybrids improved the yield potential of traditional varieties. Pesticides helped in weed, insect and disease control.  History has shown that it takes time for new technologies to gain acceptance. Biotechnology is no different. But as with any new science, a decade of widespread use has demonstrated its safety and also converted many sceptics to die-hard proponents. There is no question that the technology has proven itself though we have only seen just a few applications. The next decade of plant biotechnology is expected to yield a new generation of products that will not only offer additional benefits to farmers but also give consumers improved nutrition, taste and choice.  Biotechnology is enabling farmers to grow more food, helping keep pace with a burgeoning global population. It is also enhancing sustainability by correcting some of the problems inherent in the earlier technologies. Farmers who planted insect-protected crops were able to reduce their use of chemical insecticides by millions of kilograms. The current insect-protected crops control the major insects in cotton and corn; future products are aimed at controlling more pests and diseases in more crops. This will bring even more reduction in chemical insecticide use. In developing countries such as India and China, pesticide-reducing crops provide an even greater benefit in human safety. Pest-resistant crops have greatly reduced pesticide exposure to unskilled workers who often apply pesticides with backpacks and bare feet. Wildlife and the environment have benefited, as well.  New generation drought-tolerant crops will further expand the horizons of agriculture. With these crops, it may also be possible to grow foods in regions of the world that get little rainfall thus helping people in developing countries grow more food. Greater consumer benefits are on the horizon too. A number of research institutions are developing ways to improve the nutritional content of foods. Some of the most advanced projects include healthier food oils designed to fight heart disease, tomatoes with high levels of cancer-fighting lycopene, food crops enriched with heart healthy Omega-3 fatty acids and other essential nutrients that could reduce the risk of heart disease, cancer and Alzheimer's disease. Other technologies on the anvil include the discovery of a gene that may keep fruits and vegetables fresh longer, a tomato that ripens on the vine and tastes better, caffeine-free coffee that tastes better than beans de-caffeinated by chemicals, neutralisation of harmful allergens so that people on restricted diets can consume basic foods such as soybeans, wheat and groundnuts. In the decade since biotech crops were first widely planted, millions of people have consumed foods containing biotech-derived ingredients almost everyday. Nearly a billion acres have been planted worldwide. There has not been a single confirmed problem concerning human or livestock safety. This is not surprising to scientific experts who evaluated biotech crops before they were ever allowed into the marketplace. The scientific research in support of biotech crops makes them the most thoroughly reviewed food products in the history of the world. More than 1,500 independent, peer-reviewed studies have verified their safety. Because of its beneficial and sustainable impact on the basic elements of farming, it would not be surprising if biotechnology proves to become the most important agricultural advancement since the first farmer put a seed in the soil. ]]> <![CDATA[World's Pharma Hub]]> https://biospectrumindia.com/news/95/1481/worlds-pharma-hub.html https://biospectrumindia.com/news/95/1481/worlds-pharma-hub.html Wed, 09 Mar 2005 16:15:00 +0530 Rajiv Gulati Chairman and managing director,  Eli Lilly and Company(India). We live today in extremely dynamic and exciting times. As far as India is concerned, perhaps there have been more changes in the last ten years than in the previous one hundred. Today we are witnessing exponential economic growth coupled with great leaps of technology - Internet, cellphones and cable TV touch our lives in every way and the awareness that the technology brings, has raised our expectations sky high. Today, every professional looks forward to a global career and every organization wants to become a global player. Pharmaceutical industry also has been at the forefront in experiencing, as well bringing about changes. India is emerging as one of the largest suppliers of pharmaceuticals to the world. A big change in environment that will impact the pharmaceutical industry in India, is the transition to an intellectual property protected regime. Lets examine the changes that have happened and that will happen in the industry and for the pharmaceutical professionals, in more detail. For the last 35 years, India experienced an environment where there were no product patents. At that time, this served India well and has helped in creating organizations such as Ranbaxy and Dr Reddy's Lab which are global players in true sense. If we witness the sequence of growth, it started by importing bulk drugs and formulating them in India. The companies that identified the opportunity for new products faster, gained more. Soon there were a large number of companies including Torrent, Sun Pharma, Cadila, and Cipla that mastered this art. At that time, the more evolved organizations moved into production of bulk drugs or what is today called â€œreverse engineering.â€? Let us remember that those days the customs duty on bulk drugs exceeded 100 percent and it made eminent sense to make bulk drugs in India. This expertise in bulk drugs remained not only within the large and fully integrated pharmaceutical companies, but also lead to genesis of highly specialized companies with deep expertise in chemistry and synthesis of bulk drugs. These companies are spread throughout the country, but more so in Andhra Pradesh than anywhere else. This deep expertise led to the next opportunity: exports. Within this timeframe, Indian companies also gained tremendous expertise in formulation development. Today, India has the largest number of FDA-approved bulk and formulation plants outside of the US. Today, India has emerged as the largest supplier of generics to the world. But the year 2005 is the year of discontinuity. As the third and final amendment to the Patents Act comes close, there are concerns that are being raised within the industry and equally so in the society. Lets look at these concerns to examine their validity. One big concern appears to be the re-emergence of MNCs in India that may ring the death knell for the Indian pharmaceutical industry. Another concern is the rising prices of medicines and increasing cost of health care. However, the reality is far from it. One can understand intuitively that from 2005 onwards, the number of new molecules which are under patent to be launched in any calendar year, will not exceed a single digit. Starting with 2-3 new molecules in 2005 and in 2006, it may stabilize to 7-8 new molecules every year after that. Not only that, the molecules eligible for patent, the application for which has been filed in 1995 onwards, will start going off patent from 2015 onwards. Thus, it is predicted that at any given point of time over the next 25 years, the number of molecules under patent will never exceed even10 percent of the total molecules being marketed. Also, the patented molecules will always have therapeutic equivalents available. The countries have that embraced patents in recent past, have had exactly the same experience. To reiterate, all the existing molecules being sold in the market will continue to be available at the existing prices. Thus, the question of health care cost rising does not arise at all. What this change really provides, is an opportunity for the Indian pharmaceutical companies to globalize in a true sense. This will be the next leap forward after the tremendous strength that the Indian sector has created over the last 34 years in terms of chemistry, formulation development, sales/marketing and exports. The good companies that have utilized these 34 years effectively, are now ready to venture into discovery research, development and global marketing of the patented molecules. This is obviously a very high risk proposition, but at the same time highly rewarding too. Crossing this bridge is the most challenging transition ever been attempted by the Indian pharmaceutical industry. Any attempt to compete against the established multinationals on an equal footing will throw up the challenges of innovation, infrastructure and investments.  At the same time this new era brings new opportunities as well. This transition is already leading to many symbiotic relationships in research, development, manufacturing, clinical trials as well as biotechnology. Within the last six months, various teams from the top 10 pharmaceutical multinationals have visited India to explore the possibility of tie-up in manufacturing, formulation development as well as various stages of research. This is spawning entirely new business opportunities for existing integrated Indian pharmaceutical companies as well as the specialized organizations.  Over the last three years, dozens of CROs (contract research organizations) have started operating in India, most of them profitably. These include divisions of existing companies, new entrepreneurs as well as Indian arms of multinational CROs. With more than 400,000 English-speaking physicians and millions of untreated patients, this is not at all a surprise. India possesses similar strengths in terms of chemistry and formulation development as well. Today, 16 percent of scientists working in the pharmaceutical industry in the US, are of Indian origin. Outsourcing of various activities in the value chain from discovery to launch, is clearly the next big opportunity for India. However, this trickle can become an avalanche only on the strength of a strong IPR regime. If this infrastructure suggests partnerships, then there are even more compelling reasons for both Indian companies and MNCs to work together. Indian companies involved in discovery research face the hurdles of long gestation period, uncertainty of results, huge investments in global development and marketing. Multinationals on the other hand witness shorter period of exclusivity since competing molecules within the same chemical class are usually launched within two years of the original molecule now, against a period of 4-5 years that the first in class molecule used to enjoy. At the same time, development time and costs are increasing, and so are the marketing costs. This dilemma clearly points towards partnership between Indian companies and the MNCs as the most viable way forward. Today, no Indian company can develop a molecule on a global basis, since that requires hundreds of millions of dollars. At the same time, MNCs needs infrastructure, and by partnering with Indian companies they can save lot of money. In addition, to take advantage of the global market for the generics, research outsourcing and discovery research, Indian companies need to establish the brand â€œIndiaâ€?. I am confident that just like India is known today for software and the â€œMade In India Softwareâ€?, is sought-after in all the developed countries, similarly it will be, for various products and services in pharmaceutical industry. The partnership needs of both Indian companies and MNCs will lead to cross-licensing of molecules. An Indian company wanting to develop a molecule on global basis will need an MNC. On the other hand, an MNC relatively stranger to India, will need a distribution, sales and marketing support from Indian companies to cover the entire geography of India. At the same time, partnership with MNCs can help Indian companies gain international credibility and also move up the learning curve much faster. The other business alliances with MNCs such as outsourcing, can provide the 'cash-flow' toinvest in globalization. As far as, discovery research is concerned, the way forward in the near future will definitely mean working on new molecules within the existing class only. This art was perfected by the Japanese, and is a declared strategy of Dr Reddy's Laboratory in India. The next and the final opportunity, of course, is the development of new class of molecules, but that will take time. The other changes that are sweeping the country will continue to make India an attractive pharmaceutical market, for both Indian as well multinational companies. Relatively low inflation and fast growing GDP have lead to significant increase in disposable income. Changing lifestyle has brought in more lifestyle-related diseases and at the same time increasing income has brought about increasing awareness. Today, antibiotics which used to be the single largest therapeutic segment in Indian pharmaceutical industry, is actually declining. Today anti-diabetics, cardiovascular and anti-cancer are the fastest growing segments. The desire for better health care and ability to spend more money is leading to a literal explosion of corporate hospitals in India. Apollo today has 14 large multi specialty hospitals in India, and many satellite ones. Max, Wockhardt and Fortis are all in a mad race to acquire, build and franchise, large and small hospitals all across. This is leading to increasing demand for quality pharmaceuticals and specialized medicines. To reiterate, India is not only becoming a more attractive market, it is also becoming an attractive destination for outsourcing and partnerships. Almost all the MNCs are looking towards India, and India is on the threshold of assimilating in global economy as an equal. In the words of Dr David Webber, director of Economic Policy, International Federation of Pharmaceutical Manufacturers & Association (IFPMA), Geneva:  â€œBecause of globalization, the world is drinking Colombian coffee, using Japanese cameras, driving American cars, wearing clothes made in Asia and using Finnish mobile phones ....... Let us hope we will in future be saying: ...... And being treated and cured by novel medicines discovered in India....â€? ]]> <![CDATA[Biotech Needs Leaders and PhDs]]> https://biospectrumindia.com/news/95/2188/biotech-needs-leaders-and-phds.html https://biospectrumindia.com/news/95/2188/biotech-needs-leaders-and-phds.html Wed, 09 Mar 2005 16:11:00 +0530 Is biotech a hype? Where are the jobs? Will the industry absorb us? These are some of the questions that are crossing the minds of several students pursuing biotech education or wanting to study biotech. Dr MK Bhan, secretary, Department of Biotechnology (DBT) understands what is crossing the minds of the students and took an opportunity to address these issues with over 300 students who visited the BioAsia 2005 forum in Hyderabad from several colleges across the country. Leadership is the key â€œThere is lot of excitement being created among the people that biotechnology will solve their problems, especially in the areas of medicines and agriculture, which is  Dr MK Bhan, secretary, Department of Biotechnology (DBT), New Delhi sometimes scary,â€? addressed Dr Bhan. If the problems have to be solved, then research and innovation is the key. He reiterated that the department is incrementally adding components to function more efficiently, address the issues in the areas of intellectual property and implementation, adopt science-based regulation surrounded by public trust and good processes and finally a strategy in the area of innovation.â€? These are being addressed by several people but once things are streamlined, India needs young people who can manage these issues and manage the changes, he emphasized.. Dr Bhan informed that a lot of measures will be taken to improve public-private-academia relations. His objective is that the regulatory and policy framework should inspire and motivate the industry to focus on discovery and innovation. â€œThe objective of the policy or strategies is to make this whole area innovative. The industry on its part should capitalize on the opportunities to create new ideas and concepts through R&D,â€? he said. â€œThere is a misconception that the country is lacking in skilled and qualified manpower. It is not the right kind of thinking since practical exposure in the industry is required for any qualified person to become skilled. What we are actually lacking is scientific leadership. Without effective leadership, it is not possible to create successful enterprises,â€? Dr Bhan noted. He suggested that universities and colleges should have programmes for students to imbibe leadership attributes. While the universities and colleges will do their bit, the students have to inculcate leadership qualities. Leadership cannot be created it has to be cultivated, he said. Dr Bhan cited the examples of Bharat Biotech International's director Dr Krishna Ella, Shantha Biotechnics managing director K Varaprasad Reddy, IGIB director Brahmachari and several other people who have pioneered biotech revolution through innovation and leadership qualities in the country. Quality education is a must and those with the minds to excel will be in high demand. He added that at this point of time the recruitment from campuses is low primarily because this industry is in a nascent stage and is maturing. Once this happens, scaling will be the issue for companies. â€œI would call upon you students to do PhDs. It will never be an issue to do PhDs. DBT has several scholarships and these will be given to you. My suggestion is keep yourself abreast with the developments in the industry. BioSpectrum is providing a lot of information on this sector and we would also make a lot of information available on the regulations, scope, IPR issues etc.,â€? informed Dr Bhan.  Focus on innovation Dr Samir K Brahmachari is the director of Institute of Genomics and Integrative Biology (IGIB). He studied from IISc. and was a professor there for a long time.  He was one of the first few persons who suggested that India has the skills to tap functional genomics and latch onto this opportunity  Dr Samir K Brahmachari, director, Institute of Genomics and Integrative Biology (IGIB), New Delh as early as when human genome was being mapped. He has successfully transformed IGIB from an isolate biochemical research lab to a lab dedicated to genomics research, introducing innovative research collaboration models. Being a person, who according to Dr Bhan is very different, Brahmachari called on the student community to focus on innovation.  Dr Brahmachari stressed, â€œGlobal biotech R&D needs to tap global talents as global R&D is increasingly becoming expensive. Biotech R&D also needs high capital investment and large pool of trained manpower in state-of-the-art technologies. Also the obsolescence of knowledge and expertise is very fast. Specialized manpower is in short supply and is very expensive. That is why India and Indian scientists and researchers have a great opportunity.â€? Today, the success of Indian IT has attracted global attention and there is an inherent advantage for biotech and informatics. It is for the students to focus on whether they want to be in the back-end operations space or take up research. If they decide to go the research route, they have to work hard and focus on practical aspects. So what should be the strategy for a career growth in biotechnology? He explained, â€œMove from production centers to R&D centers. Focus on innovation than information. Take a path that is less chartered by others. Position your knowledge base in interphase science (interdisciplinary science). Researchers should patent, publish and prosper.â€? He added that one should remember the underprivileged 800 million Indians while planning for a career. What is also important is the flexibility to take up new challenges and to utilize multidisciplinary expertise. He also called for reduced time cycle from concept to implementation, instantaneous building of skills to fill up the knowledge gap to compete for the future. He reasoned: â€œthe world has shifted from industrial age to knowledge age combined-with information technology. And the challenge is multifold.â€? Ch. Srinivas Rao ]]> <![CDATA[Companies Eyeing EPO Market in IndiaÂ ]]> https://biospectrumindia.com/news/95/7003/companies-eyeing-epo-market-in-india-.html https://biospectrumindia.com/news/95/7003/companies-eyeing-epo-market-in-india-.html Wed, 09 Mar 2005 16:09:00 +0530 Shantha Biotechnics, a pioneer in modern biotech products launched its Shanpoietin - recombinant DNA Erythropoietin (EPO) in prefilled syringes at the 2nd Asian Chapter Meeting of International Society of Peritoneal Dialysis in Hyderabad in January 2005 in the presence of over 1000 eminent nephrologists from India and abroad. With this, it became the second Indian company to develop and market indigenous EPO after Wockhardt. Wockhardt has developed its own recombinant human Erythropoietin (r-EPO), and launched it under the brand EPOX in April 2001. The Hyderabad-based Shantha Biotechnics has spent over Rs 20 crore on five years of research and development for the development of the EPO product. Development of indigenous products like Shanpoietin will give an impetus to the biotech industry in terms of domain expertise and mastery over the technology and processes and also helps the country in forex savings to the tune of Rs 50 crore a year. Stating that the Indian EPO market is currently estimated at around Rs 75 crore with 70 per cent of imported drugs, Varaprasad Reddy, managing director, Shantha Biotechnics said, â€œthe company expects to record sales of Rs 10 crore a year on the product.â€? Players  Besides Shantha Biotechnics, the other major players in the Indian EPO market include LG Life Sciences India, Ranbaxy, Johnson & Johnson, Emcure Pharma, Wockhardt, Zydus Cadila, Hindustan Antibiotics. Except Wockhardt all the companies have entered into agreements with different multinationals for marketing and licensing rights to offer recombinant EPO to Indian patients.  Hindustan Antibiotics, the first drug manufacturing company to be set up in the public sector by the Indian government is selling Recombinant Human Erythropoietin Omega under the brand name HEMAX. It has entered into an agreement with the US-based Elanex Pharmaceuticals to manufacture and market Hemax in India. Emcure Pharmaceuticals, Ltd. a Pune-based pharmaceutical company has been in this market since 2002 after entering into a marketing and licensing agreement with Dragon Pharmaceuticals Inc, Canada for the distribution of its EPO in India in November 2001. The agreement provides Emcure with rights to distribute EPO in India and throughout the entire South Asian subcontinent as well as in select markets in sub-Saharan Africa where Emcure has an established presence and sales  Vintor product of Emcure  force. Ranbaxy, the leading pharmaceutical company in India too has been selling Erythropoietin under the brand name Ceriton since June 2003.  Although r-EPO is a life-saving drug for patients, because they were hitherto only imported from sources in Europe and elsewhere, they prove to be extremely expensive and usage in India is highly restricted. Wockhardt is marketing EPOX at Rs 798/2000 iu/ml lowest against its near competitors. At the launch of EPOX, Habil Khorakiwala, chairman, Wockhardt Ltd noted, â€œBy pricing it at this level, we have made EPOX therapy significantly more affordable to cancer and kidney failure patients in India. This will increase the usage of this drug in India and will be within the reach of many more patients.â€?  Johnson & Johnson, known for its consumer healthcare products like baby cream and prickly heat powder is a market leader in the EPO segment. Janssen-Cilag CRF, a business division of Johnson & Johnson and a franchise was amongst the first to launch a successful biotech drug in India namely Eprex. Eprex in a short span of five years has become the largest selling brand of Janssen-Cilag India. Its efforts in the areas of customer service, direct to patient contacts, nurse education and scientific marketing has set several benchmarks in the industry and to a large extent responsible for developing the EPO market in the country.  LG Life Sciences India Pvt Ltd (LGLSI) is another multinational company marketing EPO in India. LGLSI, a 100 percent subsidiary of the Korea based LG Life Sciences Ltd, and a group company of LG Group, has introduced nine bio-pharmaceutical products including EPO under the brand LG Espogen Inj and two diagnostic kits in India in 2002. It is looking at setting up its own production and R&D units in India so as not only to innovate, manufacture and sell in India but also build export business to other SAARC, Middle East and African countries. Potential  According to India Renal Foundation, an NGO working towards creating awareness about Chronic Renal Failure (CRF) and methods of prevention, it is estimated that one out of every 10,000 people (100 per million) suffer from kidney failure in India. The frequency of kidney failure may be more in states like Gujarat, Rajasthan as well as western Madhya Pradesh where the quality of water is harder than normal. It is also estimated that there are between 5 to 6 lakh CRF patients of whom only 10-12,000 receive treatment. India has over 1,50,000 new cases of CRF each year. Half of the number of these patients require dialysis or kidney transplantation. That is a huge financial burden as a one-time dialysis treatment costs anywhere between Rs 1,500 and 2,500 and it has to be done twice or thrice a week. Even then the mortality is 18-20 percent.  Looking at the trends and increase in the number of reported cases of CRF in India, the market for erythropoietin in India has been rising. The EPO market was estimated at Rs 35.2 crore in 2001. Last year it increased to Rs 60 crore and this year it was estimated at about Rs 75 crore.  In the pipeline  Considering the opportunity with few serious players, Ahmedabad-based Intas Pharmaceuticals is launching its indigenously developed EPO product in April this year.  R Chandrasekaran, vice-president marketing, biotech/oncology, Intas Pharmaceuticals Ltd said, â€œWe are launching the EPO product in April. The product will be made available in 4-5 strengths. Although the market is very small, it is a niche market and there are few players in this market.â€? Commenting on the possibility of price war, Chandrasekaran said, â€œWe don't initiate any price war in this niche market. Our focus will be to provide good service and better quality product to the customers. Companies like Johnson & Johnson and Ranbaxy with their well established names are doing well in the market. Intas will have an edge in this niche market as its products are targeted at oncology and nephrology.â€? â€œFor the EPO product we see Johnson & Johnson as the market leader in India. At the same time Wockhardt and Emcure are equally competitive in this space. Other key players in this field are Ranbaxy, LG Life Sciences,â€? he said.  Hyderabad-based Hindustan Bio Sciences Ltd (HBSL) and New Delhi-based Kee Pharma Limited are also looking at entering this niche market where the competition is not much. Last year HBSL announced that it had obtained approvals from the GEAC for importing and marketing EPO. According to reports, HBSL will import erythropoietin manufactured in China by Shandong Kexing Bio Products Company Ltd for marketing in India. HBSL proposes to launch the EPO in the Indian market under the brand Eposino targeting mainly the middle and lower income group patients unlike similar drugs in the market, such as Eprex of Johnson & Johnson, Hemax of Hindustan Anti Biotech and Zyrop of Zydus Biogen, which, HBSL says, are expensive.  Kee Pharma Ltd is also planning to launch recombinant erythropoietin besides other rDNA products. According to reports, with a view to strengthen its brand portfolio, Kee Biogenetics (a specialty Biotechnology Division of Kee Pharma Ltd) has signed agreements with some of the world-renowned biotech companies.  The potential opportunity and increase in the number of reported cases of CRF has made the Indian companies enter this niche market. Although eight companies are marketing different brands of EPO in India, the product is still not reaching the entire patient community. It is mainly because of the cost factor as the different brands of EPO are priced in the range of Rs 550 - 998.91 per 2000 iu/ml. It is to be seen how the price will vary with the entry of new players in this niche market following the 2004 expiry of key EPO patents in major developed world markets.  Narayan Kulkarni in Mumbai ]]> <![CDATA[Three Years of Bt CottonÂ ]]> https://biospectrumindia.com/news/95/7403/three-years-of-bt-cotton-.html https://biospectrumindia.com/news/95/7403/three-years-of-bt-cotton-.html Wed, 09 Mar 2005 16:07:00 +0530 The latest study of the growth of  biotech crops by International  Service for the Acquisition of Agri-biotech Applications (ISAAA) pointed out that Bt cotton crop area in India has increased 400 percent and Bt cotton was cultivated in over 1.3 million acres of land. This is a good sign considering the fact that the crop was allowed for commercial production in April 2002. Three Bt cotton hybrids of Mahyco Hybrid Seed Company Ltd, MECH-12, MECH-162 and MECH-184 were the first to be allowed for commercial cultivation. Besides being engulfed in controversies, the question was would the farmers lap this technology as the seeds very expensive compared to the non-Bt seeds?  â€œIn the past three years, it has been unambiguously proven that the Bt cotton technology is a farmer and environment-friendly technology that substantially improves the net economic return to the cotton farmer of this country both by means of savings in the cost of pest control and additional income generated through enhanced yield (yield that would otherwise been lost to pest damage) and improved cotton quality,â€? remarked Dr P Sateesh Kumar, director, Prabhat Agri Biotech Ltd. However, the experience of the past three years has also clearly demonstrated that the value of the technology will be realizable only when it is incorporated in the right genotype (hybrid). This is an overwhelming feeling within the industry. Added Dr Kumar, â€œMost of the debate and controversy in the past three years about Bt cotton was due to people not being able to segregate the impact of the technology from that of the genetic potential of the hybrid in which it was being delivered to the farmer.â€? However, this confusion has been cleared in the past year with the availability of the technology in a hybrid like RCH2 and the likelihood of commercial release of the Bt version of popular hybrids like Bunny, Mallika and Ankur 651 in Kharif 2005. This will make the impact of the technology more perceptible. During kharif 2004, 13 lakh packet of â€œBollgardâ€? Bt cotton seeds were sold in six states-Andhra Pradesh, Tamil Nadu, Karnataka, Gujarat, Madhya Pradesh and Maharashtra. According to Ranjana Smetacek of Monsanto India, â€œBt cotton seeds were sold to over 350,000 farmers in 2004.â€? Market researcher, IMRB is conducting a survey to assess the performance of Bt cultivation in 2004. According to various other sources, Bt cotton has grown to 1.3 million acres in Kharif 2004, from 72,000 acres in 2002, when it was released for commercial cultivation, and 2,30,000 acres in 2003. Bt cotton represented for about 11 percent of the hybrid cotton area. Further there has been considerable savings in insecticidal application ranging from Rs 1,300 to Rs 2,500 per hectare according to the International Cotton Advisory Committee (ICAC), Washington. The Bt hybrids also resulted in additional income of Rs 15,000-50,000 per hectare.  Monsanto rules For most part of these three years, it was Mahyco, which dominated the market as it was the only player permitted to commercially sell the seeds. Dr KK Narayanan, managing director, Metahelix, said â€œThe area under Bt cotton is expected to go up substantially in the coming year mainly due to more rains in the southern belt, introduction of more Bt gene-incorporated popular cotton hybrids by companies like Mahyco, Rasi and Ankur.â€? And increasing awareness among farmers about the effectiveness of Bt cotton in controlling the biggest cotton pest, boll worms is also supporting the companies to sell more Bt cotton seeds in the country. â€œMany Indian companies who have got the Bt technology from Monsanto are already conducting trials to launch their brand of Bt cotton seeds in North India,â€? Dr Kumar said. Spurious Bt Cotton Seeds in Gujarat.  Central Institute of Cotton Research  (CICR) verified the allegation of spurious Bt cotton seeds in Gujarat and found them to be positive for the presence of Cry 1 Ac gene. Here's the list. Brand Name Rakshak  Virat Captain F-1 Hybrid Cotton Seeds Research Hybrid Cotton F-1 ( Tilak) Trishul ( F1) Kavach F-1 Hybrid Kapas â€“ 151 Suraksha â€“ Hybrid Cotton Seeds  Research Hybrid Cotton F-1. Krushi-357 Sarthi The Bt cotton seeds were originally developed by Monsanto in the US and marketed under the brand name of â€œBollgardâ€?, which has been marketed by the joint venture company Mahyco Monsanto Biotech India Ltd. The company has transferred the Bt technology to over 15 Indian seed companies like Rasi, Ankur, Emergent Genetics, Ajeet, Krishi Dhan, Vikram Seeds, and Tulsi Seeds. The trials conducted by these seed companies are at different stages.  At present Rasi and Mahyco hybrids have already hit the market. Ankur is expected to get the approval for commercial release for its hybrids in 2005. Some more hybrids of Rasi and Mahyco are awaiting the GEAC green signal. â€œThere are four approved Bt cotton hybrids now in commercial cultivation, three from Mahyco and one from Rasi Seeds and it is very likely that two hybrids from Nuziveedu Seeds Ltd and one of Ankur Seeds will be approved for commercial cultivation in 2005,â€? said Dr Kumar. Though Monsanto technology has been lapped by most of the seeds companies, indigenous technology and technology from Sygenta are also being considered. Companies like Indo American Hybrid Seeds and Metahelix are working on this front. Further, Metahelix is getting ready with its own Bt Cotton. In October 2003, National Botanical Research Institute (NBRI), Lucknow, announced that its technology was ready for transfer and also licensed the same to a consortium, Swarna Bharat Biotechnics Pvt Ltd (SBBPL), for transfer.  The indigenous Bt technology and its likely commercialization in the current regulatory system are likely to happen in 2007-2008. However, if the regulatory system is rationalized it could happen earlier than that felt Dr Kumar and Narayanan.  The Bt cotton is presently priced at Rs 1600. Will the prices drop down? Dr Kumar said that the current high price of the Bt cotton technology was due to the monopoly of the technology. If the policy makers are interested in seeing that the technology is available to the farmer at a reasonable price, then the regulatory agencies should expedite the approvals for alternative technologies of similar type. Changing regulations  The regulatory system is evolving but it was felt that the evolution is too slow. The regulatory system is unable to do anything about the spread of the illegal Bt cotton, which is spreading at an unabated and alarming rate. â€œContaining the spread of illegal Bt cotton should have been the priority of the regulators, however, nothing is being done in the regard,â€? say some the seeds companies. It is widely felt that deregulation of transgenic technologies like Bt cotton (Cry1 A(c) gene in cotton) where bio-safety is proven and approved for commercial use, as it is the case in countries like the US and Australia, is the solution for several of the regulatory problems with transgenic crops like Bt cotton in India. The major reason for the inordinate delay in technology being available to the farmer in good hybrids is the current regulatory system. â€œThe current regulatory system is releasing every hybrid on a case-by-case basis after two-three years of mandatory testing for assessing purely the agronomic potential of the hybrid,â€? said Dr Kumar. However, if the technology had been deregulated after the clearance of bio-safety and varietal release was done in accordance with the existing seed laws for varietal release, then the technology could have reached the farmers in the hybrids of their choice much faster. The inexplicable and inordinate delays by the regulatory system in releasing the technology in good hybrids has led to the mushrooming of the illegal Bt cotton. Dr Kumar added further, â€œIn fact, today in the country illegal Bt cotton occupies more area (about 25 percent of total hybrid cotton area) than the legal version (about 10 percent of total hybrid cotton area).â€? At a recent meeting of the Genetic Engineering Approval Committee (GEAC) in January, the representation received from the All India Crop Biotechnology Association regarding the rampant production, sale and cultivation of illegal Bt seeds in Gujarat and other cotton cultivating states was discussed at length. Representative of the ministry of agriculture (MoA) and member secretary GEAC briefed the Committee on the action taken report by MoA and ministry of environment and forests (MoEF) respectively. The representative of MoA pointed out that the existing Seed Act does not cover transgenic crops. He therefore requested GEAC to authorize the Seed Inspectors to confiscate illegal seeds and also authorize laboratories for testing as per the provisions of Rules 1989. The committee also requested the chairman of GEAC to write to the chief secretaries of the concerned states to take necessary action in controlling the production, sale and cultivation of illegal Bt cotton seeds. With the National Biotech Policy in sight, most of them are hopeful that things will change. And 2006 would be a landmark year for Bt cotton. Ch. Srinivas Rao with inputs from Narayan Kulkarni â€œThe challenge lies in creating awareness among farmersâ€?  - Muthu Gounder Ramasami, MD, Rasi Seeds (P) Ltd Rasi Seeds is the second company in India to make commercially available Bt cotton. In an exclusive interview, MG Ramasami, managing director, Rasi Seeds, explains how his company is making its mark in the market. It is three years now that Bt cotton has been introduced. How is Bt cotton progressing? Bt cotton is doing well now. After the initial two years of setback, the release of RCH 2 Bt in 2004 has created greater confidence in the farmers about Bt technology. The farmers have understood that they get maximum benefit using hybrids with Bt technology as the yield potential is higher. How have things changed on the licensing conditions after the first release of Bt cotton? There is a definite change in the licensing conditions and the system is getting streamlined. Yet the licensing system should take into account the demand for hybrids. More hybrids are needed to meet the requirements of farmers in India, which has the largest area of cotton under cultivation in the world. How much time did it take for Rasi to get the license? It took us two years to get the first product approved since RCH 2 is a notified hybrid. Other hybrids are likely to take three years for approval. What has been your experience in getting the licenses and introducing your products in the market? How is your Bt cotton performing? Since there were lots of controversies over the technology and over the first released hybrids, we at Rasi had to organize a very large number of trials. Besides, extensive promotional activities were organized to change the perception of the farmers during 2003. We created a good awareness campaign among the farmers and as a result of this, Rasi could cover 400,000 acres in the first year itself. What are your challenges with respect to marketing your product ? The real challenge lies in creating awareness on the economic benefit among the farmers. The impression on the minds of the farmers is that the cost of Bt seeds is high. This has to be removed by effective demonstration of the economic benefit. Rasi does not foresee any threat immediately as we have very strong hybrids in the pipeline. How is Rasi Bt cotton faring and where do you see yourself in terms of the market potential and share in the next few years? What is your distribution model? Rasi Bt cotton performs very well and satisfies the expectation of the farmers. The market potential is expected to go very rapidly and nearly 80-90 percent of the hybrid area will be covered in the next three years. We are aiming to take the maximum share. The country's total requirement may rise to a level of 15 million packets and we are ambitious to develop a big market. When do you feel that the prices will come down? What are the other Bt products in the pipeline? The Bt cotton is priced at Rs 1600 per container of 450 gm. The prices are based on market forces. It will react as per the demand. We have two hybrids for North India, four hybrids for Central India and two hybrids for South India. These hybrids are expected to get the regulatory approval during Kharif 2005. Do you have a research lab and what are the areas of research? We have a research farm which is spread over an area of about 110 acres, for conventional breeding of crops like cotton, maize and vegetables. We also have a biotechnology laboratory which is equipped to handle the testing of Bt gene at various stages of transfer of Bt gene into our hybrids and also to test the quality of the seed going into the market. We have created an additional facility for DNA finger printing and genetic purity test. We also plan to expand further and initiate biotechnology work on other crops such as vegetables, paddy and maize. Who are the other major competitors for you now and when do you see the competitor's Bt products in the market place? The major competitors are Mahyco and Ankur Seeds. While Mahyco's products are already in the market, Ankur's Bt products are expected to be launched this year. The number of Bt Cotton players will increase from 2006. ]]> <![CDATA[Budget Reactions]]> https://biospectrumindia.com/news/95/1701/budget-reactions.html https://biospectrumindia.com/news/95/1701/budget-reactions.html Wed, 09 Mar 2005 16:05:00 +0530 Pharma sector upset with budget â€œFor Pharma, nothing new or significant is seen at first glance. The 150 percent weighted deduction in R&D ex penditure is being continued for another two years. The industry wanted this to continue until 2015. Similarly, the Section of the Income Tax Act dealing with 100 percent R&D units has been extended for another two years. This section deals with exemption of income. In pharma, income become realizable, if at all, only after 10-12 years of R&D work. So, when the finance minister mentioned that he was providing a stable policy environment for pharma and biotech, this is not visible. On nine items of machinery meant for the manufacturing of pharma and biotech, the customs duty has been reduced to five percent. This is a welcome step, but if the pharma unit is already importing machinery under EPCG, there is no gain. From the pharma point of view, even though the FM has recognized that it is a sunrise sector where India can leverage its skills to achieve global competitiveness, no concrete measures have been extended to this sector. Therefore the disappointment.â€? Ramesh L Adige  Whole-time Director, Corporate Affairs & Global Corporate Communications, Ranbaxy Laboratories Limited, New Delhi. â€œWe believe that only a 40 percent abatement while charging excise duty calculated on MRP (maximum retail price) would lead to increase in prices of drugs, since industry will need to recover the additional excise that has become payable under this scheme. A simultaneous reduction in excise duty from 16 to 8 percent would have mitigated this increase and would have benefited the consumers, industry as well as the government. We strongly urge the government to re-look at reducing the excise duty to eight percent, as medicines are an essential component in providing affordable world-class healthcare to the patients of India.  We welcome the introduction of VAT (value added tax) from April 1, but are dismayed at the lack of proper mechanism to enable the traders to recover the first point sales tax paid on inventory. For example, it is estimated that it would take up to three years for a wholesaler to recover this local taxes already paid on the stock held on March 31.  Extending the scope of tax exemption up to 150 percent on in-house R&D activities: This should become a permanent feature in the new policy that the government is planning to announce in the post-patent era. India has an outstanding opportunity to become a global R&D hub. All major MNCs and Indian companies are keen to invest in research in India and a stable, long-term, strategy will give this opportunity a significant fillip.â€? Rajiv Gulati MD and Chairman, Eli Lilly India, Gurgaon Farm sector happy â€œThe most commendable statement of the speech with regard to biotechnology was, I quote 'Biotechnology industry has the potential to be a global leader supplying novel technologies and products to the health and agriculture sectors. Government will provide a stable policy environment and necessary incentives to help the two industries become world leaders'. In my view, at this point of time, what biotech sector requires is a stable and transparent policy environment. The statement reflects the Government's commitment to reap the fruits of cutting edge technologies for the farming community.  In the last budget, the present government provided a clear emphasis on applications of biotechnology in Indian agriculture. Continuing those threads, this budget reaffirms the present government commitment in this direction that would certainly build confidence among both public and private sectors in India to continue research and development of new agri-biotech products. An in-depth analysis on Budget provisions bespeaks the futuristic approach of the present government in adopting frontier area of biotechnology as means to tackling problems associated with agricultural productivity, with a prime focus on ensuring nutritionally sufficient food to the steadily rising population in India.  Support from the Small Industries Development Bank of India (SIDBI) to establish a SME Growth Fund with a corpus of Rs 500 crore to boost small and medium units in knowledge-based industries such as pharma and biotech would amount to be a booster for generating new breeds of agri-biotech entrepreneurs in India.  What was missing in terms of incentives to agri-biotech sectors was the much-required allocations of substantial funding for developing various biotech crops specifically designed for Indian agriculture identified by public sectors institutions such as the Indian Council of Agricultural Research (ICAR). However, allocation of Rs 50 crore for establishment and operationalization of the National Fund for Strategic Agricultural Research is a right step in that direction.â€?  Bhagirath Choudhary National Coordinator, International Service for the Acquisition of Agri-biotech Applications (ISAAA), New Delhi ]]> <![CDATA[Avesthagen appoints new business heads]]> https://biospectrumindia.com/news/95/1351/avesthagen-appoints-new-business-heads.html https://biospectrumindia.com/news/95/1351/avesthagen-appoints-new-business-heads.html Wed, 09 Mar 2005 16:03:00 +0530 Dr Gilles Amsallem  J Rajagopalan has recently been appointed chief finance officer and general manager, administration for the entire company. He has over 25 years of management experience in several senior roles covering finance, legal and administration, at Britannia Industries Ltd.  Also Dr Gilles Amsallem has been appointed the chief operating officer, with responsibilities of driving all operations within the company. Dr Amsallem has more than 20 years of leadership experience in the development of international biotechnology companies. He has also founded and headed a successful biotech company, MIXIS Genetics. He has also lent his vast experience of the industry for corporate and business development to a number of major companies and emerging players such as Dupont, Fisher Scientific International Inc, Sorin Biomedica, Eurobio Laboratories.  Avesthagen's founder and CEO, Dr Villoo Morawala Patell said, â€œOur new appointees for COO and CFO come to us from successful entrepreneurial and established companies, and I look forward to working with them in leading our three business units into their next phase of development and commercialization.â€?  Avesthagen's team leaders for R&D and Business Development in each of the business units consists of experienced personnel with vast experience and an entrepreneurial spirit. Koen Wentink, will head the legal affairs and logistics section.  V K Jairath replaces Vishwas Dhumal In the recent reshuffle of the Maharashtra state secretariat, Vishwas Dhumal, principal secretary, Department of Industries, Maharashtra government, who was looking after biotechnology in the state since the launch of the state biotechnology policy in 2001, was transferred to the Water Supply and Sanitation Department. Dhumal was instrumental in the development of pharma-biotechnology park at Hinjewadi near Pune and also in the development of biotech industry in the state.  V K Jairath has replaced Vishwas Dhumal.  New CEO for ICRISAT Agri-Science Park VR Prasad Venkatraman Raghvendra Prasad has joined the International Crops Research Institute for the Semi-Arid Tropics (ICRISAT), as the chief executive officer (CEO) of the Agri-Science Park, Patancheru. His joining coincided with the first day of the BioAsia 2005 on February 10. He has a B.Tech degree from Indian Institute of Technology, Chennai, and a Master of Business Administration from IIM-Bangalore.  Prior to joining ASP, Prasad worked as the executive director of PSG-STEP (Science & Technology Entrepreneurial Park) in Coimbatore, where he established the largest IT incubator cum software park attached to an educational institute which nurtured 80 startup ventures. The Ministry of Science & Technology had recognized PSG-STEP with the Best Science & Technology Entrepreneurial Park in the country in 2002.  Prasad has also worked in the areas of profit center management with BHEL, Haridwar and Crompton Greaves Ltd., Mumbai, and has been active in many expert panels constituted by CII, NASSCOM and other trade and industry associations. Outside work, he is interested in playing bridge, traveling and creative writing. ]]> <![CDATA[Chidambaram's Bio-Budget Thrills Industry]]> https://biospectrumindia.com/news/95/4524/chidambarams-bio-budget-thrills-industry.html https://biospectrumindia.com/news/95/4524/chidambarams-bio-budget-thrills-industry.html Mon, 07 Mar 2005 17:10:00 +0530 More importantly, "biotechnology" finds mention repeatedly in the budget speech, signaling the mind space it has begun to capture among the policy makers. Here is what he said about biotech during the budget: " Pharmaceuticals and biotechnology are sunrise sectors. I propose to reduce the customs duty on nine specified machinery used in these sectors to five percent." " Our human resource base gives us an exceptional advantage in pharmaceuticals and biotechnology. The Indian pharmaceutical industry has declared its preparedness to produce drugs under the new patent regime. The government has already set up a Rs 150-crore research and development corpus fund for the industry. The corpus deserves to be increased and I propose to do so in phases beginning next year. India has the potential to become an attractive destination for outsourcing in drug discovery and clinical research and for co-development of drugs and manufacturing." "In biotechnology, the industry has the potential to be a global leader supplying novel technologies and products to the health and agriculture sectors. The government will provide a stable policy environment and necessary incentives to help the two industries become world leaders." "Agriculture research has a vital role to play in the strategy for reviving and encouraging diversification. Our agricultural universities and research institutions have done good work in the past and now need to be strengthened and modernized. A Task Force headed by Dr M S Swaminathan has recommended the creation of a National Fund for Strategic Agricultural Research. I am happy to announce an initial provision of Rs 50 crore for operationalizing this Fund." "What we need are world class universities, and we must make a beginning with one institution. We must have a university that will be ranked alongside Oxford and Cambridge or Harvard and Stanford. I am happy to inform the House that we have selected the Indian Institute of Science (II Sc), Bangalore, which enjoys a high reputation as a center of excellence in research and development. We shall work to make IISc, in a few years, a world-class university. I propose to provide an additional sum of Rs 100 crore as a grant for this purpose." "Small Industries and Development Bank of India (SIDBI) has established this year a SME Growth Fund with a corpus of Rs 500 crore. Small and medium units in knowledge-based industries such as pharma, biotech, and IT will be provided equity support through this Fund." Biotech Industry Demand What the Budget Proposes Pre-VC funding mechanism for startups with a) A Rs 50-crore Innovation Development Fund to be disbursed as grants to scientists at academic institutions to develop concepts In to licensable technologies b) A Rs 200-crore Product Development Fund to be disbursed as soft loans to SMEs to develop products upto "proof of concept" a) II Sc., Bangalore, singled out for Rs 100 crore to boost facilities. Opens the avenue for similar funds to other R&D institutions b) A Rs 50-crore Fund for Strategic Research in agriculture announced c) The Rs 500-crore SIDBI Growth Fund to provide equity support to biotech Companies. d) The Rs 150-cr R&D Fund for pharma and biotech to be enhanced 150 percent weighted average tax deduction to include international patenting costs. Also to be extended to 2010. Yes. But extension only for two years, up to March 31, 2007. No specific mention of patenting costs Harmonization of duties levied on imported diagnostics and life saving drugs with components and raw materials used by indigenous manufacturers of same products. Also a duty drawback provision for such raw materials Customs duty on nine specified machinery used on biotech research reduced to five percent More details likely in future notifications Five-year exemption from export obligations for biotech companies located in biotech parks/special economic zones No specific mention N Suresh Industry Reactions: " This year's budget is very 'pro-bio' and ' very positive' and promises a favorable fiscal and regulatory policy environment and necessary incentives for the biotechnology sector. The overall macroeconomic indicators continue to show improvement and the budget has clearly reinforced the strong image that India will attain on the world economic stage. There is an increased allocation of resources to address infrastructure, health, education and scientific research, which are going to be key drivers in building India as a global economic power," -Kiran Mazumdar-Shaw, president, ABLE and CMD, Biocon Ltd. "The Finance Minister has talked about pharmaceuticals as a sunrise sector, pointed out the readiness of Indian companies to face global competition in the post-patent regime. To encourage R& D, he has granted weighted tax deductions of 150 percent for two more years. It is a balanced budget." - Dr Swati Piramal, director- Strategic Alliances & Communications, Nicholas Piramal India Ltd. "Overall this is an excellent budget for all sectors of the economy. The focus on agriculture, irrigation and rural health are welcome, as these would have a long-term impact on the weaker sections of the society. The announcement of a stable policy regime in the medium term for pharma and biotech sector will allow companies to plan for the future." -Dr DB Gupta, chairman, Lupin Ltd "I was hoping the FM would seize the moment and convert the cyclical boom in the pharma industry into a structural one which has not been done and therefore overall, from the pharma industry and healthcare point of view, the budget is disappointing." -Ranjit Shahani, president, Organization of Pharmaceutical Producers of India (OPPI). "Unfortunately, there is no bold initiative to promote pharmaceutical R&D in this budget except for the welcome continuance of existing benefits. The government intends to increase the Rs 150-crore corpus for R&D beginning next year, but there have been few takers for this fund because of the cumbersome procedure. I find it odd that a government that can give excise relief to imitation jewellery and mosaic tiles could not cut duties on medicines and hospital equipment to make healthcare more affordable." - Habil Khorakiwala, chairman of Wockhardt Ltd & President of Indian Pharmaceutical Alliance (IPA). "As regards the pharmaceutical industry, no major sops have been given." -Daara B Patel, secretary-general, Indian Drug Manufacturers'Association (IDMA). " It is heartening to note that pharma and biotech have once again made their way into the FM's speech. One measure that could have given fillip to discovery would have been to exempt substantially the revenue generated from IP generating activities." -Utkarsh Palnitkar, Industry Leader - Health Sciences, Ernst & Young "The announcement of creating a stable policy environment for the biotech sector in the budget is a significant one. We are delighted that the government has accepted our various recommendations." -Nitin Deshmukh, director, ABLE. "The budget has reiterated the importance of pharmaceuticals and biotechnology." - Alok Gupta, country head, Life Sciences & Biotechnology, Yes Bank Ltd. "Instead of a stable policy environment, as promised by the government, the industry would look forward to a more ambitious and growth oriented policy environment," -CII, New Delhi "The budget is very encouraging. There is an increased allocation of Rs 2,000 crore to the S&T departments. This amount will be equally distributed amongst all sectors and biotechnology will get its due share. Now the onus is on the various agencies like DBT, DST, CSIR, ICAR and ICMR to get adequate budget allocations to the biotech sector through them. ." -Dr Arvinder M Singh, general manager, Life Sciences, PerkinElmer (India)         ]]> <![CDATA[To Patent or Not to Patent?]]> https://biospectrumindia.com/news/95/1244/to-patent-or-not-to-patent.html https://biospectrumindia.com/news/95/1244/to-patent-or-not-to-patent.html Mon, 14 Feb 2005 15:22:00 +0530 To Patent or Not to Patent? Dr. Shanthu Shantharam Indian agriculture is badly in need of capital investment and innovation and that is not likely to come about if the investors do not have a reasonable chance of recouping their investment and one of the tools that will ensure it is patent protection for their inventions. This $64-million question has been just answered through a presidential ordinance by an amendment to the Indian Patent Act of 1970 just in the nick of time. India's IPR laws had to be WTO compliant by January 2005. The governments in India since the 1990s have prevaricated a lot to bring amendments to the Patent Act as they were never able to muster enough votes to pass them in both the Houses of parliament. Granted India amended the Patent Act twice in the past, the third one for granting product patent will have to ratified by the Parliament when it will definitely run into rough weather. Leftists will oppose it on ideological grounds and rest of the Opposition will do so just to be a prickly opposition sans any ideology. They will have plenty of support from a myriad of Non-Governmental Organizations (NGOs) and Civil Society Organizations (CSOs) who will be soon organizing street protests. The present government did not have much of a choice but to issue an ordinance to avoid the parliamentary wrangle. Likewise, many countries in the developing world are scrambling to amend their Patent laws to be WTO compliant. Both politicians and administrators in India have realized that India has no choice but to bring in product patent these days of knowledge economy to invite foreign direct investment and to promote innovation in India's public and private sector. Yet, they lacked political will and courage to take the determined action publicly. Dilemma The Union Agriculture Minister has stated that he will bring amendments to the Seed Act of 1966, to grant patent over transgenic seeds that will run counter to the sui generic system of Plant Varieties and Protection and Farmer's Right Act of 2002. The new amendment to the Patent Act gives silent nod to patenting of biotech seeds and other biotech applications (products) in medicine, agriculture and environment. The opponents fear that the patent protection of transgenic seeds will amount to mortgaging the poor farmer's economic interest when private companies will start extracting technology royalty payments. But, that need not be the case. The Indian government can retain the powers to determine the method of marketing and prevent companies from charging technology fee for biotech seeds as is done elsewhere as it is impractical for the companies to collect such a payment in a country like India. Private seed companies purveying biotech seeds must tread cautiously not to use the technology licensing tactic in India and other developing countries at this point in time. Markets in developing countries will surely bear some increased costs for biotech seeds (as evidenced by the sales of Bt-cotton) that can offer superior value and profits to the grower for the money, but the same markets cannot afford exorbitant costs. Private companies for sure know the market they are dabbling in and would do well to avoid technology backlash. Biotech companies will have to realize that they have increased social responsibility now than ever before. The stated objections of many conscientious and ideological protestors are that the revised patent law will throw open the India's intellectual property for a free raid (piracy) by the multi-national companies (MNCs). In fact the bottomline goal of the Leftists and Socialists is to deny any possible benefit to MNCs who in their opinion are only concerned about their profits and do not have any concern for the poor. Many of them seem too concerned about the social and economic injustices that will be inflicted upon the poorest of the poor in the areas of agriculture and medicine. Their patent concern does not seem to stretch into other industrial sectors. They also harp on how the new patent system will offer free access to traditional and indigenous knowledge (TK and IK) of Indian communities and tribes that will be commercialized by private sector without any benefit to those who for centuries have developed the knowledge base. This point becomes particularly egregious in the area of modern agricultural and medical biotechnology. Recent instances of neem, turmeric and Basmati patents have become lightning rods for their cause and are regularly cited as how the North will exploit India's natural heritage of wealth and knowledge without an iota of benefit accruing to the Indian people. On the face of it, these allegations and accusations seem to be well founded and have been used to whip up emotions. Everyone falls for it, and that has been the reason why in India, one cannot get almost no patent protection for biotech inventions of any sort. The result is most of the medical biotech community uses licensed technologies for manufacture or use expired patents to manufacture products, or simply engage in contract research. But, that picture is rapidly changing as many as 30 patents have been obtained by Indian medical biotech companies in the US in 2003 alone. World class talent This is an elegant proof that there is world class talent in the country but they have to seek protection for their inventions outside the country. This is also one of the reasons why there is hardly any venture capital available in the country that is now likely to change. This also shows how Indian inventors have to spend enormous amount of money to patent their inventions in a foreign country as their own country's law does not grant them any Intellectual Property Rights (IPR). Other than the lone plant gene patent for Ama1 held by the Department of Biotechnology (DBT) and Professor Asis Datta of Jawaharlal Nehru University in the US, there is really no other sign of Indian agribusinesses having patented any invention in recent times. It should not be a surprise that India's investment in R&D in medicine and agriculture is still an insignificant part of the overall investment. In the medical sector, the generic drugs will soon dry up with the proposed patent amendment, and the fear expressed is that India will be denying low cost drugs to even poorer countries if the patent protections for life saving drugs are monopolized for 20 years. Need of the hour Indian agriculture is badly in need of capital investment and innovation and that is not likely to come about if the investors do not have a reasonable chance of recouping their investment and one of the tools that will ensure it is patent protection for their inventions. This is perhaps the most important reason why Indian agricultural biotechnologists are constantly looking out for buying or borrowing novel genes and gene constructs to develop products which means they will be just doing "me too" kind of copy cat R&D. With the patent law amendment, even that will become dearer and is sure to hinder scientific and technological progress in the country. Economic impact Although the Council of Scientific and Industrial Research (CSIR) strongly encourages patenting scientific discoveries and technological inventions by its scientists, the economic impact of that is still not significant. That scenario is expected to change for the better in due course of time. But, there is also a new tendency among the CSIR scientists to file for all sorts of useless patents for which there will be no buyers. Patent filing should not become another frivolous activity like publishing "junk" scientific papers just to add to the numbers and seek personal career advancement. Patents do not always translate into successful commercialization. Sometimes defensive patents are obtained to prevent others from cashing in on the idea. Such abuses must also be prevented while implementing the amended patent law. Some critics of patent law would like to see patent protection for just "basic" inventions whatever that means. This is once again a flawed bleeding heart approach to jettison the effectiveness of the Act. You cannot have the carrot and eat it too! The basic underlying principle of patent must be to spur economic growth. If one looks at the leading economies of the world like members of OECD, one cannot help but notice that they have strong intellectual property rights and developing countries do not, and poverty in these countries is telling. Contrary to the widely held belief, IPR protection will provide social and economic justice in the long run by investment, industrialization, job creation, and overall economic development. If India and other developing economies continue to hold on to their TK and IK base without having the skills and incentives to convert them to wealth creation, it will continue to scout for technologies around the world and will end up paying dearly. In this knowledge-based era, it is important to realize that no amount of emotionalizing the issue on the basis of social justice will get our poor farmers and their ilk out of their miserable plight. In reality, Indian agriculture needs enormous investments which the country does not have and sloganeers cannot cook up investments by miracles. Poor Indian farmers cannot afford to wait forever to improve their lot. The implementation of the patent law should be designed to take care of some of the existing problems in the country. The devil is in the details. India can utilize the provisions of Article 7 of the TRIPS agreement to suit the social and economic needs of the country and at the same time make it worthwhile for the investors in developing technology. (To be concluded) Shanthu Shantharam Biologistics International, Ellicott City, MD, USA sshantharam@biologistics.us ]]> <![CDATA[VC investing in life sciences rises to $5.6 billion in 2004]]> https://biospectrumindia.com/news/95/2845/vc-investing-in-life-sciences-rises-to-5-6-billion-in-2004.html https://biospectrumindia.com/news/95/2845/vc-investing-in-life-sciences-rises-to-5-6-billion-in-2004.html Fri, 11 Feb 2005 17:41:00 +0530 The Software Industry hit a three-year high in calendar 2004 with $5.1 billion and remained in the top slot as the largest single industry category. Software represented 24 percent of all venture capital dollars. Danisco to acquire Genencor JJ BienaimÃ© Danisco A/S, one of the world's largest producers of food ingredients, and Genencor International, a diversified biotechnology company, have signed a definitive agreement for Danisco to acquire all of the outstanding shares of common stock of Genencor. "Being an advanced and recognized biotechnology company, Genencor will expand Danisco's knowledge base significantly and broaden our access to an important new business area, industrial enzymes," said Alf Duch-Pedersen, Chief Executive Officer of Danisco. "Our two companies know each other well and the synergy is obvious," said JJ BienaimÃ©, Chairman and Chief Executive Officer of Genencor. "Together, we will have the depth and the reach to achieve the vision we've had for our business." Danisco develops and produces food ingredients, sweeteners and sugar. Chelsea Therapeutics, Ivory Capital to merge Chelsea Therapeutics Inc. and Ivory Capital Corp. have signed a definitive agreement to combine in a reverse merger transaction that will establish the merged company as a publicly listed, well capitalized biopharmaceutical company. Founded in 2002, Chelsea is currently privately held. Following completion of the merger, expected to close in the first quarter of 2005, the merged company will be known as Chelsea Therapeutics Inc. and will be headquartered in Charlotte, NC. The company will adopt Chelsea's business strategy, continue to be quoted on the OTC Bulletin Board and continue to be headed by Chelsea's current management team led by CEO Dr Simon Pedder. "This transaction will further strengthen Chelsea's position as a competitive player in the biotech market," commented Dr Pedder. Genetronics to acquire Inovio Avtar Dhillon Genetronics Biomedical Corp., a late stage developer of oncology and other therapies using electroporation to deliver drugs and nucleic acids, announced the acquisition of Oslo-based Inovio AS, a leader in patented gene delivery technology. The deal includes cash in Inovio's treasury of approximately $775,000 and approximately $2.0M in current and anticipated appropriations for biodefense research from the US Army and other committed grants. The share purchase agreement consists of $3million in cash, $7 million in Genetronics stock. "This is a perfect strategic fit as we increase our licensing activities in the area of DNA therapies involving intramuscular electroporation for application to vaccines and immunotherapy," said Avtar Dhillon, Genetronics' President and CEO. "Together with Dr. Mathiesen and his team, we will promote and advance gene-based collaborations with existing and new partners." PDL to acquire ESP Pharma Protein Design Labs Inc. (PDL), a leading developer of humanized monoclonal antibodies, and ESP Pharma Inc. (ESP Pharma), a privately held, hospital-focused pharmaceutical company, have entered into a definitive agreement under which PDL will acquire ESP Pharma for $300 million in cash and approximately $175 million in PDL common stock, or an aggregate value of approximately $475 million. ESP Pharma was founded in April 2002 around the acquisition of several therapeutics from Wyeth, including ESP Pharma's leading product, Cardene IV. ESP Pharma generated total net product sales in excess of $90 million in 2004, a significant increase over 2003. Mark McDade, Chief Executive Officer, PDL said, "With this transaction, we have filled the void in the one major functional expertise PDL lacked, namely commercialization capabilities. Upon closing, we will have created an exciting new, fully integrated, hospital-focused biopharma company." ]]> <![CDATA[EDIT]]> https://biospectrumindia.com/news/95/1842/edit.html https://biospectrumindia.com/news/95/1842/edit.html Fri, 11 Feb 2005 16:48:00 +0530 Threshold of Greatness  N Suresh, Editor, BioSpectrum Our technologist president A P J Abdul Kalam and economist prime minister Manmohan Singh deserve fulsome praise for their superb gesture to recognize the contributions of the leaders of the life sciences and biotech industry. As the saying goes, when it rains, it pours. The Republic Day honors to bestow the Padma Awards, the nation's highest civilian honors on five life science industry captains and two other leading lights of the sector in one swoop has been an unprecedented gesture of recognition of the fledgling industrial sector. Never in recent times have seven industry leaders been chosen for the nation's acclaim in a single year. And it so happens that five of the seven leaders are from the life sciences sector: Bhai Mohan Singh of Ranbaxy, Kiran Mazumdar-Shaw of Biocon, Varaprasad Reddy of Shantha Biotechnics, Yusuf Khwaja Hamied of Cipla and Cyrus Soli Poonawalla of Serum Institute. It may be a sheer coincidence that two of these awardees were recognized with the BioSpectrum Person of The Year Award â€“Kiran Mazumdar-Shaw ( 2003) and Cyrus S Poonawalla ( 2004).The other two industrialists to be honored this time are: Azim Premji of Wipro and Brijmohan Lall of Hero Motors. Dr Martanda Varma Sankaran Valiathan, the veteran cardiologist who has been in the forefront of promoting biotech in recent years and Prof V S Ramamurthy, secretary, DST, a strong supporter of the biotech industry, too have been honored with Padma Vibhushan and Padma Bhushan respectively this year. The Padma awards have been usually been reserved mainly for writers and artists, social workers, doctors, scientists, journalists and bureaucrats. Occasionally a few industry leaders were considered for the awards. So it is a double bonanza this time. Industry leaders got some attention and majority of them are from the life sciences sector. Every one of them richly deserve the nation's highest civilian honors. Bhai Mohan Singh has been instrumental in launching one of India's widely admired pharmaceutical company, Ranbaxy, which is watched globally for its capabilities. Hamied and Cipla have been in the forefront of rewriting some of the rules of the global pharma marketplace. Cipla's unique AIDS vaccine cocktail has been saving the lives of thousands of poor patients in Africa. Biocon and Kiran Mazumdar-Shaw's amazing success story continues to be chronicled widely in the mass media and business press. Varaprasad Reddy's triumphs against heavy odds to build Shantha Bitoechnics with the hepatitis B vaccine and take on global pharma giants is already part of the modern folklore in technology business sectors. And Cyrus Poonawalla's unsung efforts to build Serum Institute and India as the world's vaccine maker has finally caught the national attention. Every second child born in the world today gets a vaccine shot from Serum's products. Above all, Prof Ramamurthy's contribution to the growth of the biotech sector was unheralded so far. It was the Technology Development Board (TDB) chaired by him that spotted the potential in Shantha Bitoechnics and gave the seed money to keep it going in the mid-1990s. TDB has been playing the role of venture capitalists to this sector which the professional VCs have so far been very reluctant to support. The highest levels of the government have recognized the potential of the biotech sector. Now if the sector can get a little help from Finance Minister Palaniappan Chidambaram (we have a Biotech agenda for him in the magazine), the industry will more than live up to the nation's trust in it.   ]]> <![CDATA[BioCareers]]> https://biospectrumindia.com/news/95/1790/biocareers.html https://biospectrumindia.com/news/95/1790/biocareers.html Fri, 11 Feb 2005 16:41:00 +0530 "The Next Wave in Bioinformatics is Systems Biology" The Bangalore-based Institute of Bioinformatics (IOB) has recently developed a Plasma Proteome Database (PPD), which gives all the necessary information on the blood protein, in a single site. This work was based on an international grant from Human Proteome Organization (HUPO), the world's largest body for protein analysis and signifies the official recognition of IOB as a leading world player in the emerging field of bioinformatics. Dr Akhilesh Pandey, chief scientific officer, IOB, shares his views on the future of bioinformatics and development of human resources for this niche segment in India. What is the potential or opportunity for the bioinformatics segment in India? Is the current buzz about bioinformatics justified? Bioinformatics has immense opportunity and good potential and the current buzz about bioinformatics is justified. Bioinformatics is the use of computers for solving biological problems. Bioinformatics not only includes data storage, data mining and management, but also the computational methods and techniques like simulation/dynamics employed in biological systems to understand the underlying cellular phenomenon. Any system where the information can be represented digitally offers a potential application for bioinformatics. Genome sequencing projects have generated a vast amount of data that needs to be analyzed thereby creating a thrust area for many bioinformatics initiatives. An important part of the field of bioinformatics is the development of new technology that enables analysis, sharing and exchange of data to proceed at a very fast pace, for example, the Internet and the development of computer clusters and grid infrastructures. Many scientists find bioinformatics exciting because it holds the potential to dive into a whole new world of uncharted territory. Biological questions ultimately drive all bioinformatics experiments. Important biological questions that can be addressed by bioinformatics are many and include understanding the genotype-phenotype correlation for human diseases, understanding structure-function relationships for proteins, and understanding biological networks. The next wave in bioinformatics is Systems Biology, which involves the integration of genomics, proteomics, and bioinformatics information to create a whole system view of a biological entity. Needless to say, the opportunities in the bioinformatics segment are vast and there is a shortage of trained personnel in this field today. What are the necessary skill sets for students to step in this field and meet the industry standards? Ideally, a student should have sound knowledge of molecular biology, a passion for life sciences and an inquisitive mind. Apart from this, he or she should possess: A knowledge of UNIX/Linux the operating system used for many computational biology programs; A good grasp of the concept of relational databases, which are the heart of bioinformatics; Programming languages such as Perl or Python, which are popular in the field of Bioinformatics. In the future, knowledge of object-oriented databases may be increasingly important. Expert knowledge of sequence-analysis programs like BLAST is critical. Web skills, of course, are necessary, including the ability to write Hypertext Markup Language (HTML). What gives one applicant an edge over another? Recruiters get excited over applicants who have applied computational biology skills in a practical way. Technical developments such as molecular genetics, transcriptomics, proteomics and metabolomics provide the analytical base to support this advance but demand novel statistical and computational skills. In this post-genomic era, bioinformatics is rapidly developing and it is essential that current and future researchers learn the most up-to-date applications and approaches. Post-genomic applications demand a level of informatics skill beyond that previously employed in biosciences. There is a shortage of individuals with the necessary multidisciplinary training to meet this demand but the availability of such individuals will be critical to future understanding/interpretation of the large amounts of available data. What are the key characteristics of this segment as opposed to those in other biotech segments like biopharma and bioagri? Biopharma and bioagri are the ultimate applications of bioinformatics. Without these applications bioinformatics could not have assumed the pride of place it has. In spite of the large number of Indian students trained in bioinformatics, there is a big gap between the demand and expertise available. Where does the problem lie and how can it be addressed? Some of the Indian universities have set fairly good standards of teaching bioinformatics but the same is not uniform and as far as the private institutes that have mushroomed to take advantage of the hype, I have no comment. The only thing I can say at this point is that if India has to enter the big league, it should focus on the quality of training of its young people in Bioinformatics. Further, I feel that the best training in this field can only be provided by those who are active in performing research in this area and not those who are simply teaching outdated concepts or those pertaining only to a particular sector such as the pharma sector. Rolly Dureha ]]> <![CDATA[BioShaker - Dr C Kameswar Rao]]> https://biospectrumindia.com/news/95/2727/bioshaker-dr-c-kameswar-rao.html https://biospectrumindia.com/news/95/2727/bioshaker-dr-c-kameswar-rao.html Fri, 11 Feb 2005 16:24:00 +0530 Bush's Indian Bioterror Advisor Dr C Kameswar Rao needs little introduction to the biotech community. An eminent botanist, he is currently the executive secretary of the Foundation for Biotechnology Awareness and Education (FBAE), a non-profit organization that works to spread biotechnology awareness and to promote sustainable development through safe biotechnologies. Dr Rao is also a member of a US-based committee of the National Academies, which is dedicated to the furtherance of science and technology and to their use for the general welfare. It is this role which has brought him global prominence now. He is a core member of a committee that keeps a hawk's eye on potential bioterrorism development around the world. Every one knows the passion of US President George Bush in fighting global terror. US fears bio weapons and Rao is probably the only asian to help Bush spot future troublemakers. A product of Andhra University, Dr Rao started off his teaching career at the Department of Botany, Andhra University, Waltair. He then moved on to join the Bangalore University in 1967 where he served as lecturer, reader, professor and chairman in the departments of botany and sericulture for 31 years until his retirement in 1998. Dr Rao has published about 60 research papers, two monographs, one book, six booklets in Kannada, and co-authored a text book on Biology for Pre-University. His book, "Database of Medicinal Plants", was published by the Government of Karnataka (2000) and was distributed free of cost and is accessible on the Internet at www.indmedplants-kr.org. During his career, Dr Rao has received several international academic grants including the Commonwealth Academic Staff Fellow (1980-81); the Royal Society and Nuffield Foundation Bursar (1983-84); the Canadian Institute of Biotechnology grant for an international conference on Biorecognition at Montreal, June 1992; and the European Commission grant for an international conference on Sustainable Agriculture for Developing Countries, January 2003, at Brussels, Belgium. Dr Rao's research interests are applications of computers and phytochemistry in plant systematics and databases of medicinal plants. He has worked at the Natural History Museum, London and the Royal Botanic Gardens, Kew, UK, on computer applications in Plant Systematics, and developed online packages for the identification of the south Indian dicot families and the world monocot families. "India needs transgenic varieties of oil seeds and millets" - Dr C Kameswar Rao You are a member of the US-based Technology Futures Committee. Can you tell us more about it? Well, I am a member of a committee of the National Academies called Advances in Technology and Prevention of their Application to Next Generation Biowarfare Threats. The committee examines the current research in life sciences in biotechnology. Biotechnology is a potential means to combat the danger of bioterrorism, through production of diagnostics, drugs and vaccines against bioweapons and their source organisms. Nevertheless, it can also be a source of bioweapons. Now we have what is known as dual-purpose technologies i.e., those that can be used for beneficial purposes and also for ulterior purposes. See it is not difficult to obtain or to redistribute strains of pathogenic bacteria and viruses from the repositories, under the pretext of research and drug development. The techniques, reagents and information that could be used for offensive purposes are readily available and accessible. The expertise and know-how to use or misuse them is distributed across the globe. So the committee examines the research going on in life sciences in biotechnology and the possible impact of using them in bioterrorism and biowarfare. It recommends to the government changes in practices that could improve the capacity to prevent the destructive application of biotechnology research while still enabling legitimate research to be conducted. Thus the committee helps to minimize threats from biological warfare and bioterrorism without hindering the progress of biotechnology. How does the general public perceive agricultural biotechnology? If you talk to people on the streets of India, it becomes apparent that few people are against biotechnology per se. Medical biotechnology, for example, is broadly accepted: there seems to be no reservations about biotechnology if the end result is believed to be improvements in medicine. Agricultural biotechnology is another matter. Although more than 100 generic products have been made available in India in recent years, we have had enormous difficulties in introducing Bt cotton and genetically modified mustard. And we face similar difficulties now with regard to the introduction of 'golden rice'. The public perception of genetically engineered agricultural products in India is largely one based on suspicion and doubt. This is mainly due to misinformation and ignorance about what agricultural biotechnology is, and what it can do for us. What do you think is the reason behind the fear and suspicion in public mind? The anti-technology activists are responsible for all misinformation. Information is taken out of context, blown up out of proportion and disseminated widely through the media. For example, cotton plant contains a polyphenol that is used in medicine as an abortive agent and to induce menstruation, in effect it is an antifertility factor. A representative of a farmers' organization once cautioned that Bt cotton contains this antifertility factor, and this led to a major scare-women refused to pick Bt cotton in the field and as a result, farmers faced delays in picking. But the point is that if Bt cotton has an antifertility factor, it is because it is a cotton plant and not because it is Bt cotton. Hence there is a need for more industry sponsored action to bridge the information gap. These activists hardly have any scientific background. They seamlessly mix up scientific, ethical, economic, societal and political issues. If you talk about 'golden rice', they will say that it will not reach the poor. Why will it not reach the poor? The agreement between the government and the patent owners is that at any time, if the cost of 'golden rice' is higher than that of a comparable variety of rice sold in the market, the government will have to pay the technology costs, otherwise the technology transfer of 'golden rice' to developing countries is free of cost. Talking of 'golden rice', I would like to clarify something here. It is a misconception that 'golden rice' contains vitamin A. It actually is rich in beta carotene, which is converted into Vitamin A in our body. Your comments on the agricultural biotechnology scenario in the country ... India principally needs transgenic varieties of oil seeds and millets. The cultivation of these crops fell drastically in the past four decades in preference to cultivation of rice, tobacco, cotton, sugarcane and other cash crops. And as a result, the rural economy of the country is upset. Namratha Jagtap   ]]> <![CDATA[BioResearch]]> https://biospectrumindia.com/news/95/2608/bioresearch.html https://biospectrumindia.com/news/95/2608/bioresearch.html Fri, 11 Feb 2005 16:19:00 +0530 Indigenous AIDS vaccine on the cards Dr Pradeep Seth, professor and head, department of Microbiology, AIIMS Today India is home to the world's second largest HIV population after South Africa. From one AIDS case in 1986 to over 5.1 million HIV positive people today, experts claim that the number could quadruple by 2010 in the country. An HIV vaccine is the need of the hour to curb this deadly scourge. Help will be at hand soon for India's 5.1 million population living with HIV/AIDS. The National HIV Reference Centre at the All India Institute of Medical Sciences (AIIMS) under the leadership of Dr Pradeep Seth, professor and head, department of Microbiology, AIIMS, has not only perfected the technology for an indigenous AIDS vaccine, but has also developed affordable detection kits, PCR tests and even a therapeutic AIDS vaccine. Indigenous AIDS vaccine The indigenous rDNA/rMVA vaccine is constructed from select genetic sequences of HIV and is delivered with the help of a plasmid vector in the prime dose and a highly attenuated strain of Vaccinia virus-Modified Vaccinia Ankara (MVA)-as the vector in the boost dose. The vaccine has been tested on mice as well as monkeys with remarkable results suggesting induction of robust immune response. The blood samples from the HIV vaccine immunized animals were found to destroy the cells coated with the HIV virus protein. Special tests were conducted and it was found that the vaccine had induced development of antibodies to the virus, which specifically neutralize HIV virus isolates in vitro. "The vaccine was found to be highly immunogenic and tremendous HIV specific immune response was seen during the animal trials", said Dr Seth. Supported by the Department of Biotechnology (DBT), the HIV vaccine is ready to enter the preclinical toxicology test prior to human clinical trials. The hurdle now facing the scientists is the lack of expertise and infrastructure for producing GMP grade rDNA vaccine batches for the preclinical toxicity trials. Efforts are presently on, in collaboration with an industry to mass-produce the vaccine for these trials. An urgent thrust is needed to bring the vaccine to the clinical trial stage, otherwise looking at the alarming AIDS statistics today, it will be a case of too little, too late for the Indian population. HIV detection kit Earlier, in 1999, Dr Seth developed an HIV detection kit, which was designed to detect HIV Subtype C, the virus subtype prevalent in the Indian and African continent. The kit, though not commercialized, is highly sensitive and very cost effective at Rs 8-10 per test. For the kit, Dr Seth had used indigenously designed peptides. Having filed a patent for this technology, he is looking at the industry to upscale the technology and make it commercially available throughout the country. Acquired Immuno Deficiency Syndrome (AIDS) is caused by the Human Immunodeficiency Virus, which infects CD4+ cells, also known as T-helper cells or helper T lymphocytes, a vital part of the body's immune system. There are mainly two types of HIV virus, HIV-1 and HIV-2. HIV-1 causes most of the infection all over the world and AIDS is diagnosed when an infected person has a CD4+ cell count below 200 cells per micro liter of blood or/and shows specific opportunistic infections and/or cancers. The HIV infection is normally associated with a "window period"- the length of time after infection that it takes for a person to develop enough specific antibodies to be detected. This period generally ranges form eight to twelve weeks and is a potentially dangerous period. As the presently approved HIV antibody detection tests used for the detection of HIV infection are not able detect it during the window period, hence it may unknowingly get transferred to many unsuspecting individuals. Dr Seth's lab has developed a "Matrix Real Time PCR" test, which can detect the presence of the virus during the window period also. The test is very sensitive and has the ability to detect a small number of about 100 copies of the virus in the body. And it can analyze 1000 samples at a time, making it an ideal tool for the diagnostic labs and also blood banks. In addition, Dr Seth has developed a "RT PCR" test by which the exact viral load in the body can also be detected. He has filed a patent for both these technologies. Once upscaled at a commercial level, these tests would be available at a very affordable cost for the Indian masses. The Matrix RT PCR test would cost about Rs 40-50 per test where as RT PCR test would cost Rs 700-800 as against to Rs 3000-4000 per test presently available in the market. Therapeutic AIDS vaccine In a quest to further conquer this rapidly spreading disease, Dr Seth has recently developed a therapeutic AIDS vaccine by adding adjuvant to his existing HIV vaccine candidate. This aims to control the virus replication in AIDS patient, thus considerably enhancing the health and life span of the patient while simultaneously reducing his dependence on antiretroviral drugs. Significantly, once developed, this would be the first of its kind of therapeutic HIV vaccine in the world. Today, about 60 percent of HIV-positive adults who do not receive treatment develop AIDS after 12 or 13 years. Many with positive HIV develop opportunistic infections early and succumb to such infections. Presently only antiretroviral drugs offer some hope to AIDS patients, but they can have serious side effects. In such a scenario, a therapeutic AIDS vaccine is the need of the hour. Based on his extensive studies of immunodeficiency virus, Dr Seth has also designed PCR based genotypic and phenotypic tests to identify/screen the quasi mutant or resistant HIV strains in patients to avoid unnecessary retroviral medication to them, as studies have indicated that nearly 5-15 percent of infected individuals have primary resistant strains. What makes Dr Seth's research work on the AIDS virus all the more impactful is the fact that all of it is based on HIV-1 Subtype C, the most prevalent virus subtype in India. It causes infection in more than 80 percent of the cases in India. Overall, there are ten genetic variants of HIV known as subtypes - from A to K, which are in circulation in different geographical areas. In India HIV-1 Subtype C is prevalent, while in Europe and America, subtype A and B are common. AIDS vaccine clinical trials Worldwide over 30 AIDS vaccine candidates are in human clinical trials in 19 countries, according to the International AIDS Vaccine Initiative (IAVI), which is supporting research in India among other countries. Since 2001, IAVI has been partnering the National AIDS Control Organization (NACO) and Indian Council for Medical Research (ICMR) for developing a vaccine to counter HIV subtype C prevalent in India. Human trials of vaccines against different strains of the virus are already being conducted in the US, Europe, Africa and South America. Human trials of a US-made HIV vaccine are due to start in Pune early this year. The National AIDS Research Institute (NARI) based in Pune will be conducting the research. The first phase of testing of the vaccine, named Adeno Associated Virus based HIV sub-type C, will be conducted on about 30 adult volunteers. The central ethics committee of the Indian Council of Medical Research and the Drugs Controller General of India has approved the trial. The NARI scientists will monitor the volunteers over a period of one year to test for side effects and the immune system's response to the vaccine. These trials are a part of the multi-national multi-centric study involving two sites each in Germany and Belgium in addition to the Pune site. Rolly Dureha Bacterium uses sonar-like strategy to "see" enemiesBacterium uses sonar-like strategy to "see" enemies For the first time, scientists have found that bacteria can use a sonar-like system to spot other cells (either normal body cells or other bacteria) and target them for destruction. Reported in the December issue of Science, this finding explains how some bacteria know when to produce a toxin that makes infection more severe. It may lead to the design of new toxin inhibitors. "Blocking or interfering with a bacterium's "detection" mechanism, should prevent toxin production and limit the severity of infection," said Michael Gilmore, lead author of the study, and currently director of research at the Schepens Eye Research Institute and professor of ophthalmology at Harvard Medical School. Gilmore and his team have spent years studying the bacterium Enterococcus faecalis, one of the leading causes of hospital-acquired infections, to find new ways to treat them. These infections are frequently resistant to many, and sometimes all, antibiotics. Scientist have known since 1934 that especially harmful strains of Enterococcus produce a toxin that destroys other cells, including human cells and even other types of bacteria. They also knew that this toxin was made only under some conditions. Until this study, scientists were unable to explain how the bacterium knew when to make it. In the Science study, Gilmore and his team found that this toxin is made whenever there is another cell type in the environment near the bacterium, such as a human blood cell. They discovered how these bacteria know when other cells are present, and respond accordingly. In the laboratory, the team found that Enterococcus releases two substances into the environment. One substance sticks to foreign cells. The second substance reports back and tells the bacterium to make the toxin. If no cells are in the area, the first substance sticks to the second, preventing it from reporting back, and as a result, no toxin is made. Stem cells might make biological pacemaker Researchers from Johns Hopkins have found the first evidence that genetically engineered heart cells derived from human embryonic stem (ES) cells might one day be a promising biological alternative to the electronic pacemakers used by hundreds of thousands of people worldwide. Electronic pacemakers are used in people with certain heart conditions that interfere with a normal heartbeat. However, these life-saving devices cannot react the way the heart's own pacemaker normally does. Green human embryoid bodies Photo credit: Ronald Li/Tian Xue, Johns Hopkins Medicine) In the researchers' experiments, described in the online edition of Circulation, human ES cells were genetically engineered to make a green protein, grown in the lab and then encouraged to become heart cells. The researchers then selected clusters of the cells that beat on their own accord, indicating the presence of pacemaking cells. These clusters triggered the unified beating of heart muscle cells taken from rats, and when implanted into the hearts of guinea pigs, triggered regular beating of the heart itself. "These implanted cells also responded appropriately to drugs used to slow or speed the heart rate, which electronic pacemakers cannot do," said study leader Ronald Li, assistant professor of medicine. "But many challenges remain before this technique could be used for patients. We want to bring this to the clinic as fast as possible, but we need to be extremely careful. If this process isn't done properly, it could jeopardize a very promising field." The genetic engineering of the ES cells, accomplished by Tian Xue, a postdoctoral fellow at the School of Medicine, inserted a gene (for green fluorescence protein) so that the human cells would be easily distinguished from animal cells in the experiments. "To our knowledge, these are the first genetically engineered heart cells derived from human ES cells," said Xue. "We're now using genetic engineering to customize the pacing rate of these cells, for example. For any future clinical applications, you want to make sure that the beating rate is what you want it to be." The stem cell approach isn't the first Johns Hopkins research to create a biological pacemaker, but it is likely to be a better choice if the heart is very damaged. In 2002, Hopkins scientists reported that inserting a particular gene into existing heart muscle cells in a guinea pig allowed the cells to create a pacemaking signal. "If heart damage is extensive, however, it might be preferable to introduce new pacemaking cells, rather than to convert existing cells into pacemakers", noted Li.   ]]> <![CDATA[Bio Pharma]]> https://biospectrumindia.com/news/95/2698/bio-pharma.html https://biospectrumindia.com/news/95/2698/bio-pharma.html Fri, 11 Feb 2005 16:06:00 +0530 Innovation Dawns With the advent of the product patents regime, Indian companies have to enter the era of innovation, which is going to separate leaders from mere generics drug players On December 26, 2004, the Indian government promulgated the Patents (Amendment) Ordinance 2004 as also the Patents (Amendment) Rules, 2005 to comply with the TRIPS obligations. Though the Ordinance was promulgated only recently, Indian pharmaceutical companies have been gearing up to the WTO regime and are adopting a strategy of R&D-based innovative growth. Indian pharmaceutical companies, which did not spend even a fraction of a percent on R&D 10 years ago, are now spending 6-8 percent of their annual turnovers on R&D against the international norm of 12 percent. The transformed Indian pharma industry is itself looking for patent protection, particularly the biotech sector, in which India has bright prospects. Reacting to the ordinance, R Rajagopalan, president, Discovery Research, Dr Reddy's Labs said, " Personally I feel, this ordinance would boost R&D activities and accelerate growth of the Indian pharmaceutical companies. India has a strong intellectual capital and whatever potential India has shown in IT business, the same sort of impact will also be seen in the pharmaceuticals industry." Considering the importance of patents, Dr SN Maity, former controller general of patents, designs and trade marks, observed, "The brain product is the future of Indian economy. The brain products are to be protected properly by Intellectual Property Rights to strengthen the economy. Indian companies can do that as they have capability no less than others." India's approach With the product patents regime, Indian biopharmaceutical companies will not be able to make or sell products patented by MNCs unless they have been licensed to Indian biopharma-ceuticals companies. The biopharmaceutical companies including biotechnology companies who have not invested in R&D may find themselves pushed out of the market as they have to compete with multinationals, which have new products generated through extensive R&D. But the Indian biotechnology stands second to none in terms of innovative capability. It has skilled and intellectual scientific pool that can do wonders in R&D. Chandrajit Banerjee, senior director, Confederation of Indian Industry noted, "Indian companies have seen this coming and have accordingly realigned their strategies to gear up for the change. The underlying fact is that they should focus on innovation in their R&D and also utilize the benefits of the new product regime." Research based companies will however be able to successfully compete with MNCs at global level, leave aside at the domestic marketing level reverberate industry majors. It will take number of years before new-patented products generated by the R&D efforts of Indian companies would be marketed, said Rajesh Jain, joint managing director, Panacea Biotec Ltd. Leading companies are investing on R&D to generate their own IPR and come up with new products. Companies realize that it will take a number of years to develop their own pharmaceutical products. They are eager to join hands with MNCs for co-developing and or co-marketing of patented products of MNCs. Developing their own IPR is today a very important component of their long-term strategy. The new law has the provision allowing the government to force the patent holder to grant licenses to the local company in the case of emergencies or for exporting medicine to countries facing public emergencies. This will also pave way for inlicensing agreement between Indian companies and multinationals. In this regard, many Indian companies have already started discussing with the multinationals to launch their patent products in India. Besides Indian companies would gain from manufacturing of biogeneric, bio-comparative and bio-improvic products that are either off patent or likely to be off-patent soon. Indian companies have also found a new route of growth namely "contract manufacturing". The global companies have realized that it is advisable to outsource manufacturing and focus more on research and marketing. Indian companies will find contract manufacturing as a means for high growth returns. "The real impact for outsource is expected in the next few years from the generic drugs market. The market for generic is growing annually by 14 percent. Indian companies are likely to concentrate on generic molecules, bulk drugs and intermediates," noted Rajesh Jain of Panacea Biotec Ltd. Rajiv Gulati, chairman and managing director, Eli Lilly and Company (India) Ltd, a leading provider of biotech drugs, observed, "It is not only the biopharmaceutical sector, but also the overall pharmaceutical sector that has been bracing up by putting more resources on R&D efforts. The day is not far when a drug developed, commercialized and marketed in India by an Indian firm sees the light of the day." Government Initiatives The government has taken steps after signing TRIPS agreement on IPR related issues in general and product patent in particular. Infrastructure modernization: According to reports, the Rs 120-crore modernization plan of the patent offices across the country is nearing completion. The offices in Delhi and Kolkata will be ready by March, Chennai office by April and the Mumbai office by June. The Patent Information Service, Nagpur has been developed as an Intellectual Property Training Institute (IPTI). Besides launching a website of IP offices, a distinctive logo for IP administration has also been designed. The government is also working on to set up Integrated IP offices in each of the four metro cities so as to house all activities in one building. C-DAC has undertaken comprehensive computerization of operations of these IP offices and the initial level of computerization has been completed. Front office software has been installed to generate computerized information about status of patent applications, receipt for filing of patent applications, etc. Online search facilities have also been established and the patent offices have been provided with ISDN facility to ensure uninterrupted connectivity. Improved novelty search in patents is being ensured through connectivity to international databases. Further, CD-ROMs were also acquired for this purpose and library facilities strengthened. Over 70,000 patent records were digitized and a searchable database would also be put on the website. According patent office website www.patentoffice.nic.in, the output of patent offices vis-Ã -vis the year 1999-2000 has nearly trebled. This has gone up from 2,800 cases in 1999-2000 to over 10,000 cases in the year 2002-03. Out of a cumulative backlog of around 45,000 patent applications, preliminary scrutiny reports have been issued in respect of over 42,000 applications. The problem of backlog of pending patent applications is being addressed both through legislative and administrative measures. Administrative measures have already started showing results in terms of improved output. These will be further complemented by the legislative measures contained in the Patents (Amendment) Act, 2002 and the Patents Rules, 2003, expected to be brought into force shortly. Human resources: Of the total sanctioned staff of 271 (technical), there were 155 people working day and night to complete the process within the given time of 52 months. In all there are 600 people (including technical and support staff) working in different places across the country. The Patent office has been recruiting people for technical posts (examiners) since 2001. But with no lucrative future prospects they were not sticking to their jobs. However 62 new examiners (for patents) were recruited recently and trained by IPTI, Nagpur. IPTI offers unique opportunity to gain first-hand knowledge and training in patents and other IPRs. It is the only institute of its kind in the country set up by Ministry of Commerce and Industry, Government of India. In addition to this, about 181 examiners will also be recruited shortly. The patent office has also been making efforts to update the skills of the registered agents, as there has been lot of changes that have taken place in the last few years. There were 617 registered patent agents across the country. The advocates, who had the registered way back in 1945 as agents are still holding the registration numbers. These agents claim to be experts but most of them are not up to the mark, say industry people. The patent office is taking steps to update their skills on the latest developments in the field of IPR. Status of applications The applications by both the Indian as well as the MNC companies at the patent offices have been swelling since January 1, 1995. The patent offices in the four metros as on December 31, 2004 received a total of 8,926 applications for the grant of product patent. Of which the patent office has received 2,488 requests for examinations. According to reports, majority of the applications were from US companies. For the multinational companies, which have branches in India to market their products in the country, the filings are done under the PCT (Patent cooperation Treaty) from the US by the parent company. Rajiv Gulati of Eli Lilly and Company (India) Ltd said, "Sitting here, we are not aware of the exact numbers. It is difficult for us to make a guess as ours is basically a marketing company that has a bunch of biotech drugs discovered by the parent corporation." Although the industry people and the officials find it difficult to make a guess on the breakup of applications between different industries, it was noted that around 7,000 applications could be from the pharmaceutical sector and the rest in the areas of agro-chemicals. Take for example USV. It has about 21 applications filed which includes three for biotechnology, 10 for chemical process research and eight for drug delivery systems research. Biocon has filed over 200 patent applications, both national and international. It ranks No.4 among all companies in India in this area. Panacea has filed 93 patent applications, of which 48 applications are available in black box. It is difficult to assess the total numbers of biopharmaceuticals/biotechnology companies who might have dropped applications in the mailbox. Nitin Deshmukh, director, Association of Biotechnology Led Enterprises (ABLE), observed, "There are applications filed from biotech companies. I am not very sure on the number of applications filed from biotechnology industry. Considering the total number of applications, less than one percent of this number might be from the nascent biotechnology industry. About 20 companies from biopharmaceuticals and about 10 bioagriculture companies could have filed the applications for product patent." The government has initiated steps to modernize the IP offices so as to speed up the process. Progress has been made in areas such as modernized infrastructure, extensive computerization, human resource development, digitization of records, efficiency, transparency and operational environment of global standards (see the box on Government's initiatives). Yet, there are issues that need to be addressed immediately. "To speed up the process, the patent office has to hire more examiners and strengthen the existing infrastructure. It has already issued an advertisement for recruiting as many as 200 examiners. And we have also suggested the government to link all the offices of IPR based at the four metros and requested the government to set up dedicated IPR court. Countries like Indonesia already have such courts, " commented Dr Ajit Dangi, director general, Organization of Pharmaceutical Producers of India (OPPI), the premier association of pharmaceutical manufacturers. Rajesh Jain pointed out certain that changes like electronic filing of patent application, information on status of the filed application, discussion on objections by the patent officer and applicant via telephone or videoconference would help in speedy filing and examination of the applications. "It is going to be tough for the patent office as the people working there are obstinate to any kind of changes," said Nitin Deshmukh of ABLE. According to Rajiv Gulati, "Resource is the biggest challenge although government has already done a fair bit in augmenting the resources at these offices. Continued focus on upgrading the manpower with ongoing training would definitely help in tiding over the current situation." Chandrajit Banerjee of CII too felt the same. He said, "The ability to examine cutting edge, innovative technologies for patentability lies primarily with the capability of the examiners. First of all there is a dearth of number of examiners in the Indian Patent Office. Second, there is an urgent need for upgradation of their qualitative skills through training to meet International Standards. Lastly, there is a need to establish specialised IP Courts for litigations arising out of opposition to patents." Process deadline Though over 200 examiners are working day and night to complete the process, the industry believes it would take at least two-three years before all the applications are disposed. Rajiv Gulati felt, "It might take two-three years for the companies to be able to offer their patented products in India." Rajesh Jain observed, "Patent office used to take five-seven years to process the applications, but with the modernization of the patent offices, the time to process the application has been drastically reduced. The Section 11(b)(3) provides that the request has to be made to process application of black box so that process is completed within 12 months of December 31, 2004 or 48 months from the date whichever is later. In view of a large numbers of applications, it is likely that it will take years before any of the applicants is granted patent. Once the patent product is granted, it usually takes five-eight years to complete the clinical trials and regulatory approval and introduce the product in the market." However, the government maintained that it would complete the whole process before 52 months. Ashok Jha, secretary, Department of Industrial Policy & Promotion said, "The specific timelines have been put in place for granting patents. It has been reduced from a maximum period of 104 months to 52 months and the minimum period from 27 months to five months." What's in for innovators? Product patent will help big Indian pharmaceutical companies as well as the multinationals. The industry hopes that the patent ordinance will be converted into a full-fledged law by Parliament, when it comes for discussion during the Budget session. However, most of them believe that there will not be too many changes in the Indian pharmaceutical industry as the government has just promulgated the ordinance and has to remove many ambiguities in the ordinance. At least for the next two years, things will continue without much change they opined. Decisions on fresh investment with focus on R&D, clinical trials and productive collaboration between Indian and international companies will take place only if there is an assured climate of world-class patent protection. When India is on threshold of growth on all fronts, the government should help to open up the healthcare sector as well. The government has agreed to revisit the ambiguous provisions of the patents ordinance and rules to make the product patent regime credible and protect the interests of consumers and producers. Panacea Biotec feels that MNCs do have some amount of diminishing edge over the Indian companies since they have been investing on R&D at a desired level leading to new IPR and new products. "The initial edge of MNC over the Indian biopharmaceutical companies will vanish in a couple of years since it is expected that many products based on Indian biopharmaceuticals IPR will be launched in the market very soon globally," said Rajesh Jain. Rajiv Gulati noted that a patent is a patent, whether it is granted to an MNC or an Indian biotech company. "The overarching philosophy is whoever chooses to invest in research, will reap the consequent benefits as the days of reverse engineering are certainly going to end," he said. Echoing similar views Chandrajit Banerjee said, " Irrespective of MNCs or Indian companies, the edge is for all companies which are innovative in their product profiles and who are continuously innovating and introducing new products." Patent has assumed great importance in recent times since its basic function-to promote innovation-is an essential component of economic growth and social evolution. Patent is not just an incentive to invest in the innovation process per se, but is also increasingly important for trade and industry worldwide. For developing countries like India, patent is an essential component of the framework to attract foreign investment and faster technology transfer. So the coming days are for innovator companies and the era is for innovation. Narayan Kulkarni with inputs from Rolly Dureha in New Delhi and Srinivas Rao in Bangalore ]]> <![CDATA[BioClusters Feb 2005]]> https://biospectrumindia.com/news/95/2029/bioclusters-feb-2005.html https://biospectrumindia.com/news/95/2029/bioclusters-feb-2005.html Fri, 11 Feb 2005 15:55:00 +0530 AUSTRALIA ASX and biotech industry move towards reporting code The Australian Stock Exchange (ASX) and Australia's Biotechnology Organization (AusBiotech) announced that the biotech reporting code committee met to progress the development of the biotechnology industry reporting code. The committee, jointly formed by ASX and AusBiotech, will review the current draft of the code with a view to finalizing it as a Code of Best Practice. The Code of Best Practice for reporting by biotechnology, medical device and other life sciences companies has been developed to enhance communication and understanding between companies and the investment community and to promote investor confidence in the sector. The Code was launched as a working draft in April this year and a number of companies have already adopted it as a standard in their reporting to the market. ASX Deputy CEO Colin Scully said: "This initiative will assist the growth and acceptance of the biotechnology industry. Disclosure of information is fundamental to inspiring confidence in open markets. Ensuring we have a common reporting framework and shared understanding of information, it adds to investor confidence, and therefore contributes towards a lower cost of capital for the industry." AusBiotech Executive Director Tony Coulepis said: "The draft reporting guidelines are an important step in raising the reporting standards in Australia towards world best practice and therefore in developing the Australian biotechnology industry. Source: www.ausbiotech.org ASIA PACIFIC Singapore's Biopolis attracts industry leaders Biopolis, a research complex in Singapore, which was launched a year ago, has achieved 90 percent occupancy, consisting of national research institutes and leading BMS industry players. In recent months, two leading companies GlaxoSmithKline (GSK) and Isis Pharmaceuticals Singapore set shop. In September, GSK announced to establish set up its first pre-clinical research facility for neurodegenerative diseases in the Asia Pacific region. GSK plans to invest S$62 million in this research facility. This brings GSK's total investment in Singapore to over S$1 billion, which has been used to build up strategic manufacturing facilities, expand its production facility and undergo numerous research collaborations. Isis Pharmaceuticals Singapore opened a research lab in October last and focuses on discovering new micro-RNA drugs and antisense drugs to treat Severe Acute Respiratory Syndrome (SARS), cancer and blood diseases. This facility allows its parent company, Isis Pharmaceuticals INC, a company involved in the area of RNA-based drug discovery and development, to expand its efforts into Asia. A*STAR funds $48m to boost research The Biomedical Research Council (BMRC) of the Agency for Science, Technology and Research (A*STAR) has awarded $48.2 million funding to 74 biomedical research projects in Singapore in its third grant call. The successful applicants were selected from a pool of over 240 researchers from Singapore's public institutions excluding research institutes under A*STAR. "We are very pleased with the strong response and the quality of submissions. The 95 percent jump in volume over the previous Grant Call reflects strong growth in biomedical research activity in Singapore. Our expert panel of reviewers has also noted a higher standard of submissions," said Associate Professor Kong Hwai Loong, Executive Director of the BMRC. Of the 74 successful proposals in the third Grant Call, 45 are for basic science, and the remaining 29 are on translational research, which bridge laboratory science and clinical applications. Funding support ranges from 12 months to five years. The research grants range from $250,000 to more than $3 million. The projects cover a broad spectrum of research areas, including common diseases such as cancer and heart ailments. Source: www.a-star.edu.sg "Taiwan to Attract NT$150 billion by 2010" - Dr. Johnsee Lee, president, Taiwan Bio Industry Organizations, and president, Industrial Technology Research Institute, Taiwan What is the current status and outlook of the biotechnology industry in Taiwan? Taiwan's biotechnology industry includes biotechnology, pharmaceuticals and medical devices. In 2003 the total annual revenue for these industries in Taiwan was approximately NT$131.6 billion, of which NT$29.6 billion came from biotechnology - 0.9 percent of the total global revenue - represented by 223 companies, each with an average revenue of NT$133 million. Business scope covered included genomics, drugs, diagnostics, agricultural biotechnology, environmental biotechnology, protein drugs, contract research organizations, biochips and bioinformatics. The island's pharmaceutical industry returned NT$61.4 billion,- 0.4 percent of the global total - with 429 companies active in this sector, averaging NT$143 million per company. The medical devices industry returned NT$40.6 billion,-0.6 percent of the global total, coming from 397 companies, with an average revenue of NT$102 million each. The biotechnology workforce size is 35,610, of which 7,200 are in the biotechnology industry, 14,224 in the pharmaceutical industry and 14,186 working in the medical devices industry. (Source: Development Center for Biotechnology, Taiwan Institute of Economic Research, Biotechnology and Pharmaceutical Industries Program Office, MOEA). The strategy of Taiwan's biotechnology industry development is clear and focused. Industry, institutions and government bodies all follow developmental guidelines as set forth in the Promotion Plan for the Biotechnology Industry. The Plan was first released by the Executive Yuan branch of the government in 1995, and has been revised biannually ever since. With the 2003 amendment to the Plan, growth targets for the industry were set to 25 percent per year over the following five years. Such growth is expected to bring into the sector investments of NT$150 billion over the same period. An additional goal was for the establishment of more than 500 biotechnology companies over the next 10 years, with 18 large-scale international standard companies established by 2010. Taiwan's plan is multi-faceted: To position Taiwan as the center for human clinical trials in the Asia Pacific; for the island to become a regional center for the manufacturing of biotech products; to be the center for genomic R&D in Asia; to become a worldwide subtropical floriculture center; and to build the most vibrant biotech-focused venture capital industry in Asia. Based on recent data, Taiwan's biotech companies are involved in the following fields: Clinical trials/bio-equivalence, clinical animal experiments, biotech-related contract manufacturing, cord blood preservation services, bioinformatics, biochips, drug development, herbal medicine, physiological/ biochemical monitoring systems, monoclonal antibody drugs, gene diagnostics and gene therapy, stem cell technologies, transgenic plants and animals, technology for developing pharmaceutical dosage forms, genetically modified products, and artificial organs. These new companies represent the current booming biotechnology industry within Taiwan, and reflect the efforts and promotion of our government. Taiwan understands that for its life science industry goals to be met, it needs to more fully integrate with the international biotech community. By encouraging investment, joint ventures, biotech transfer and research collaboration between its local companies and institutions and their overseas counterparts, benefits will come not only to Taiwan but also to all collaborating parties. What are the government's initiatives and support programs to boost the industry? In order to provide a beneficial environment for start-up companies and investment & development of the industry, the government has built up infrastructure such as transportation, telecommunications, electrical power, water resources, environmental protection, biotechnology parks, and a workforce of highly educated professionals. Additionally it has enacted personnel training programs, started biotech-related investment funds and established investment incentives . The government has specified that companies in the biomedical and special chemical industries sectors meeting the criteria of the Incentive Program for the Manufacturing and Technical Service Aspects of Major Emerging Strategic Industries may choose to take advantage of a five-year tax holiday or shareholder investment credit. To create a more attractive investment environment, the government has set up a series of tax breaks and other incentives, encouraging local and overseas biotech entities to invest in Taiwan, stimulating the growth of the industry as a whole. Tax Benefits Government R&D Assistance Program Preferential Policies Executive Yuan's Development Fund Stock Listing (IPO) Recommendation How you see the growth of biotechnology industry in Taiwan? Through the government's full support, the infrastructure, related laws and regulations for biotechnology have gradually reached completion status. The sector has seen active participation in R&D and the setting up of technical cooperation agreements with overseas companies. Taiwan has therefore already reached a commendable level of achievement in the development of its biotechnology industry. To further contribute to the growth of the industry, the government will establish 3-5 biotechnology seed funds, totaling NT$15 billion. These funds will pour massive amounts of capital into the local industry. It is estimated that in the next five years, the annual growth rate for Taiwan's biotechnology industry will be 25 percent, and the industry will attract NT$150 billion in investment. Five hundred biotechnology companies are to be established within the next ten years, with a goal of 18 international large-scale biotech companies being established before 2010. In the future, Taiwan needs to implement a two-pronged strategy: innovative research-orientation and niche-orientation, in order to become a vital cog in global biotechnology. Furthermore, it will look to aggressively develop products that have the most growth potential and which are extremely competitive, laying strong foundations. Narayan Kulkarni AMERICA James Greenwood is BIO president Former Pennsylvania congressman James Greenwood took over as president of the Biotechnology Industry Organization (BIO) on January 5, 2005. BIO represents more than 1,000 member organizations across three major areas of research and development: healthcare, food and agriculture, and industrial and environmental biotechnology. Carl B Feldbaum, president of BIO from its inception in 1993, has retired. James Greenwood "The biotechnology industry is dedicated to solving humanity's toughest problems; it is creating cures for heartbreaking diseases, improved crops for better nutrition, and clean biofuels for a better environment," said Greenwood. "The future looks bright for the next generation of companies and products as well. Investment in private biotechnology companies - almost all of them small research-and-development firms funded by venture capitalists - hit a record $5 billion in 2004, while the industry as a whole raised more than $20 billion," said Greenwood. Outlook bright With a spate of new products hitting the market, Ernst & Young projects industry revenues will rise almost 20 percent, to $51.4 billion, in 2005. That growth is driving employment gains that are expected to outpace the general economy at least through 2012, according to calculations based on US Labor Department statistics. "Growth is accelerating in dozens of regions in America, and it encompasses both startups and large-cap firms," said Greenwood. "That record of growth will help BIO in the coming months as we pursue a policy agenda designed to ensure the financial markets and regulatory system continue to support this innovative industry, which has come so far, so fast, but still has a long way to go." FDA approves breakthrough therapies The FDA in 2004 approved 32 new therapeutic products discovered, developed or marketed by biotechnology and related companies, according to a BIO analysis. The approvals include the first cancer drug designed to stop the growth of the blood vessels that feed tumors (Avastin), two cancer drugs targeting a cancer growth factor (Erbitux and Tarceva), and new medicines for multiple sclerosis, macular degeneration, and pain. The year 2004 ended with the FDA's approval of a first-of-its-kind genotyping test that helps doctors and patients select medications and doses for treatment of cardiac disease, psychiatric disease and cancer. At the earlier end of the pipeline, two critical fields of research - biodefense and embryonic stem cells - both got a boost in 2004. The new federal BioShield law provides $5.6 billion over 10 years to procure vaccines, therapies and other products critical to protecting against bioterrorism. Biotech agriculture expands Biotech crop adoption continued to soar in 2004, nine years after the introduction of the first biotech staple crops. In the US, biotech varieties accounted for 85 percent of soybeans, 76 percent of cotton, and 45 percent of corn. Six biotech crops (canola, corn, cotton, papaya, soybean and squash) were found to increase the incomes of the US grower by $1.9 billion and crop yields by 5.3 billion pounds, while reducing pesticide use by 46.4 million pounds, according to a new study from the National Center for Food and Agricultural Policy. The impact of biotech crops is rapidly expanding in the rest of the world. A December study from food and trade policy analyst C Ford Runge found that biotech crops are now being grown in 18 countries, and research and development is being conducted in another 45 countries. The global commercial value of biotech crops grown in the 2003-04 crop year was $44 billion, according to the study. EUROPE France Biotech recommends accelerating efforts France Biotech, the French biotechnology industry association presented the 2004 French Biotechnology Industry Report at a conference in Paris on December 15. This study was put in place by France Biotech and its partners, and under the scientific direction of Pr. Pierre Kopp, economist, University Paris I. Prime Minister Jean-Pierre Raffarin This third edition of 2004 describes the main developments in the biotechnology sector in 2003, as well as the trends, and the 2004 financing activities. In 2003, and for most 2004, the French biotechnology industry was marked by a dramatic fall of sources of financing from both venture capital and stock markets. Subsequently, company investments and jobs stagnated in the sector. Nevertheless, the institutional and financial environment of the biotechnology sector was positively impacted at the end of 2004 by some key measures implemented by the French government, which has been favoring R&D driven companies with measures such as the Young Innovative Company status (JEI in French) and the commitment of insurers to invest an additional 6 billions euros in SMEs before 2007. These measures were conceived and submitted by France Biotech and the Strategic Council for Innovation to the French government. In addition, the research environment, key for the life sciences industry, will benefit from the creation of the National Science Agency (Agence Nationale de la Recherche in French), announced by Prime Minister Jean-Pierre Raffarin on June 29, 2004. France Biotech recommended the Agency to be well capitalized and focused on Life Sciences and Bionanosciences. The panorama unveiled by France Biotech makes watch of a moderate optimism: it underlines the relative fragility of the national industry, the need for accelerating efforts that will drive to a successful takeoff with a focus on the measures having the strongest and fastest impact, such as the Young Innovative Company status. Despite positive shivers at the end of 2004, France remains globally behind compared to its competitors: both at the level of public investments in academic research in the field of life sciences, and at the level of investments made by venture capital in the young life sciences companies, the French efforts are three times inferior, in corrected GDP, to the US'. It is also noticed that the total amount of capital raised by the whole national industry, including during the good years, is much lower than the development cost of a single drug, estimated between $500 m and $800 m. The conference provided the opportunity to review on 2004 France Biotech's actions, and will unveil France Biotech's latest proposal to the government, namely to create a Young Listed Company status (JEC). This status will address the need of SMEs to access to the stock market and will combat the lack of appetite of institutional and stock-market investors in growing young technological companies by offering tax benefits to those who invest in innovative SMEs. The French government implemented measures to help SMEs. Nevertheless, the 2004 biotechnology study clearly shows that international recovery is yet to benefit the French and European life sciences industry. Philippe Pouletty, President of France Biotech said: "If the sources of financing for biotechnologies have been running dry the last two years, the new institutional environment in place starts bearing fruit". Source: www.france-biotech.org AFRICA Kenya imports Bt cotton for trials Kenya has imported Bt cottonseed from the US for field trials. Dr Charles Waturu, Kenya Agricultural Research Institute's (KARI) Thika Center director, said that Bt cotton, which has a gene that is resistant to stalk-borer, is expected to reduce pesticide spraying from five to two times. "Of all the input in cotton, 32 percent is channeled to pest control, and the Bt cotton will lead to a reduced number of pesticide spray until harvest time," he said. The trials are about to start at KARI farms in central Kenya. The Kenya Plant Health Inspectorate Service (KEPHIS) has inspected the trial sites and has given the go-ahead for the project. Currently, cotton is grown on approximately 2.5 million hectares in Africa, most of which comprises small plots of less than five hectares. The introduction of Bt cotton on the continent has the potential of dramatically increasing yields among the small holder farmers. The National Biotechnology Committee approved the application for Bt cotton only last year. Source: www.africabio.com ]]> <![CDATA[TOP STORY]]> https://biospectrumindia.com/news/95/7493/top-story.html https://biospectrumindia.com/news/95/7493/top-story.html Wed, 19 Jan 2005 15:31:00 +0530 INDIA'S TOP BIOTECH SCHOOLS Ranking of top institutes imparting education in Biotech. The last few years have seen the emergence of the Biotech industry in India. The industry is expected to cross a billion dollar mark during the current financial year. The rate of growth which was nearly 40 percent last year, may accelerate with some of the patent related hurdles getting addressed. As with many other areas, India's capabilities, be it in manufacturing, clinical research or services are well recognized worldwide. Top 20 Ranking of Institutes Offering Biotech Courses Parameter Scores of the Top 20  Biotech Institutes The Overall Top 20 Ranking of Private Institutes Ranking of all Institutes on Faculty Parameter Parameter Scores of the Top 20 Private Institutes The growth of this industry means a focus on the educational system from the point of availability of well-equipped educational institutes and colleges, which can address the need of trained manpower. Unlike other industries like IT and Telecom, the availability of options as well as the ranking of institutes/colleges are not well documented in the biotech industry. The Best Institutes Amongst all institutes and colleges, which are imparting education at the undergraduate and/ or postgraduate level in Biotech, University of Hyderabad, Hyderabad emerges as the best top ranked institution in the country. It is followed by Anna University, Chennai, at the second position, University of Pune, Pune, at the third position, IIT, New Delhi at the fourth and JNU, New Delhi at the fifth position. Faculty/ student ratio Entomology Research Institute, Chennai Qualification University of Hyderabad, Hyderabad Experience University of Hyderabad, Hyderabad Publications University of Hyderabad, Hyderabad Patents University of Hyderabad, Hyderabad As one would expect, amongst Top 20 Biotech institutions in India, 16 are public and only four are in the private sector domain. Barring last few years in which private sector has invested money in higher education, education has largely been in the public domain. Amity Institute of Biotechnology, Noida, Vidya Pratishthan's School of Biotechnology, Pune, CSK HP Agricultural University, Palampur and Avinashilingam Institute for Women, Coimbatore are the four institutions in private sector which occupy slots amongst India's Top 20 institutions in Biotech area. It may further be observed that none of these institutions figure amongst top 10. The Top 20 list is dominated by institutions in Northern and Southern parts of India. Eight colleges/ universities each figure in the list from North and South leaving only four in the Western region. The Eastern region is conspicuously absent from the list with no institution appearing in the Top 20 list. As has been mentioned earlier, four parameters have been used to arrive at the overall score or ranking - Faculty, Infrastructure, Industry interaction and Placements. Even within Top 20, ranking of institutes vary substantially on these four parameters throwing up gaps, which can be addressed by the respective institutions. To take some examples: University of Hyderabad occupies top rank under Faculty but does not do well on Infrastructure or on Placements. On the latter two parameters, the University does not figure even in top 5 list for a particular parameter. It however, scores very well on Industry interaction. Anna University at Number 2 overall rank does consistently well on Faculty, Industry interaction and Placements. However, much more is required to be done on building up the Infrastructure for Biotech students. University of Pune tops in terms of its Placement score, does well on Faculty but needs to improve substantially both on Infrastructure and Industry interaction. Given its fourth overall ranking, IIT, New Delhi displays similar scores for Faculty, Industry interaction and Placements but leaves much to be desired in relation to other institutes on Infrastructure. JNU, Delhi does well on all scores but Placements does not seem to be its top priority. To closely examine status with respect to Faculty, the institutes were sorted just on the Faculty score. While the top 5 institutes and their  Within Faculty, the top rankers on sub parameters include Faculty/ student ratio Entomology Research Institute, Chennai Qualification University of Hyderabad, Hyderabad Experience University of Hyderabad, Hyderabad Publications University of Hyderabad, Hyderabad Patents University of Hyderabad, Hyderabad On the sub parameter scores of Infrastructure, the top rankers being Library Guru Gobind Singh Indraprastha University, Delhi Lab Equipment: Jawaharlal Nehru University, Delhi Dedicated PCs Institute of Engg. & Technology, P.U., Chandigarh rankings remain same as in overall, changes are observed after the fifth position. Newer institutions enter the top 20 list which is based only on the faculty score. It is further observed that only one private institute figures in the top 10 by Faculty namely, Amity Institute of Biotechnology. Within Infrastructure, there are only two private institutes which fall in top 20 Infrastructure ranking. Moreover, none of the institutes fall in private domain in the top 10 ranking. An analysis was also carried out to look at institutes more closely only on the Industry interaction parameter. There are seven private institutes amongst top 20 list of institutes sorted only on this parameter. Amongst the top 10, there is only one private namely, Kolhapur Institute of Technology, Kolhapur. As regards the sub parameters relating to Industry interaction, the top rankers are:z Products developed: Univ of Hyderabad and Kolhapur Institutes of Technology Sponsored projects: IIT Mumbai Royalty inflow: Jawaharlal Nehru University, Delhi It is interesting to note that private institutes domuch better on placement parameter. Amongst the top 10 institutes sorted only on this, there are five institutes from the private sector. Amongst the sub parameter scores of Placement, the top rankers are as follows: Student placement: Anna University, Chennai Listed companies visiting: University of Pune, Pune Offers by listed companies: University of Pune, Pune The survey was conducted by BioSpectrum through CyberMedia Research Methodology In order to maintain objectivity and avoid biases, CyberMedia Research decided to base its methodology to rank institutes on measurable and quantifiable data. As a result, the research team did not seek perceptions and opinions of stakeholders such as students or industry to rank the institutes. Quantifiable data was collected from institutes directly using a structured questionnaire on different parameters. The parameters were identified in consultation with very senior experts from the industry, education and R&D through in-depth telephonic interviews. Discussions were held with as many as 15 senior personnel having in-depth knowledge of the industry. Experts felt that Faculty, Industry Interaction, Infrastructure and Placements were the most important parameters on which the institutes should be ranked. Having zeroed down on parameters, about 30 experts were again contacted through a structured questionnaire to arrive at the parameter weights. The following means emerged based on data received from experts: Parameter Weights Faculty 32 Infrastructure 32 Industry interaction 16 Placement 20 Faculty and infrastructure emerge as the two most important parameters ahead of placement and industry interaction. These weights were applied to parameter scores of an institute to arrive at its final score. The above parameters were further broken into sub-parameters as per discussion as follows: Faculty  â€¢ Faculty per student â€¢ Faculty qualification â€¢ Faculty experience â€¢ Publications by the faculty in national and International journals at different points of time â€¢ Patents filed/granted both nationaland international at different points of time Infrastructure  â€¢ Expenditure on library â€¢ Expenditure on lab equipment at different points of time â€¢ PCs/ student (dedicated for biotech students) Industry Interaction  â€¢ Products developed by the institute in production â€¢ Projects sponsored to an institute from private and government sources â€¢ Royalty inflow at different times Placements  â€¢ No. of students placed against needed â€¢ Visits of prestigious companies for recruitment â€¢ Placements offered by listed companies A pre-tested structured questionnaire was sent to more than 300 directors/principals of Biotech institutes. The research team received responses from 95 institutes and colleges. Responses of 27 were rejected because they were only scantily filled. While a certain degree of verification was done, in most cases, data was taken as stated. Clarifications were sought in cases with extreme values or where units were doubtful. The research team spent considerable amount of time accurately analyzing the filled-in data for each institute: â€¢ For each institute, a score was arrived at for each of the parameters. For a particular parameter, the score was a composition of each of the sub-parameters. For example, Faculty score of an institute would be composed of faculty/student, qualification of faculty members, and experience amongst others. Infrastructure score would be similarly composed of capital expenditure on equipment, expenditure on books, and availability of PCs per student. â€¢ Appropriate and largely consistent weights were used for sub-parameters wherever necessary. To give an example, faculty members with PhDs and above were given a higher weight than non-PhDs to arrive at the qualification score. Similarly, publications in international journals were given a higher weight than publications in national journals. More recent publishing of papers, more recent capital expenditure or more recent patents filed/ granted have been given higher weights. â€¢ Sub-parameter scores were indexed with hundred points being granted to the institute with highest score for a particular sub-parameter. Indexed scores were then added up for each institute to arrive at the total for a particular parameter. Scores were than averaged on hundred. â€¢ Each of the parameters (faculty, infrastructure, interaction and placements) was further weighed as per weights provided by experts to arrive at the total score of an institute. The institutes were than ranked as per this score on an overall basis. About CyberMedia Research CyberMedia Research is a part of Cyber Media India Limited - a specialty media house, with nine publications including Dataquest, PCQuest, Voice&Data, Living Digital and BioSpectrum in the infotech, telecom, consumer electronics and biotech areas; and a media value chain with 12 websites, events and television. The group's media services include market research, content outsourcing, multimedia, gaming, and media education. Leveraging on more than 400+ man-years of market research and consulting experience of more than a decade and a half and over 20 years of undisputed leadership in print and electronic media, CyberMedia Research has been formed to address emerging market opportunities. Positioned as a young, innovative and knowledgeable research agency, it has been successfully engaged with leading organizations such as Britannia Industries, Shaw Wallace, Schneider Electric, JWT, TBWA, Bunge Agribusiness, Aaj Tak, Star Group, Sony Entertainment, Nickelodeon, Pitch and Exchange4Media on various research assignments in the recent past. Besides conducting traditional research, some of its proprietary methodologies and models include: CLASS Model for testing of TV commercials PARS (Perception Analyses and Reengineering System) for content analyses RTVA Model for viewers' analyses BrandSol for brand tracking Agency's column on evaluation of new ad campaigns appears in PITCH (India's only advertising and marketing magazine) every month. Looking forward, plans are afoot to bring in unique predictive consumer analyses technology to India in collaboration with one of the world's largest in the area. Research Team CyberMedia Research functions under the guidance of Ravi Sangal as its president. Before starting CyberMedia Research, Ravi Sangal steered the growth of well known IT market research agency, IDC India Ltd, for over 12 years. He is an alumnus of BITS, Pilani and IIT, Delhi. Ravi has been extensively quoted as industry analyst and is known for his sharp observations, timely and relevant inputs. He holds the distinction of being amongst the few analysts worldwide for accurately predicting the slowdown of the Indian Software export industry in 2001. He has been a key speaker at many national and international conferences of repute. He has been associated with United Nations as a consultant besides being an active IT committee member of Confederations of Indian Industries and FICCI. Sabina Anand is an electrical engineer from Punjab Engineering College, Chandigarh and a Post Graduate in the field of Advertising & Mass Communications from Narsee Monjee Institutes of Management Studies (NMIMS), Mumbai. She has about 4 years experience in advertising and market research. She has handled a range of market research assignments relating to product tests, concept tests, customer satisfaction and ranking studies. Her project management skills involve handling qualitative as well as quantitative researches. She has worked for some prestigious clients like Joyco, Whirlpool, Thermax and now BioSpectrum. A voracious reader, if she can find time from managing her baby. Neha Sangal, an economics graduate from Lady Shri Ram College and a Post Graduate from Amity Business School, has worked extensively in the field of marketing before making major contributions in the area of market research. Specializing in quantitative methods, Neha has done extensive work in ad testing and conducts assignments independently for large organizations. Besides research, Neha is fond of traveling, listening to Indian Classical music and cooking. ]]> <![CDATA[TRENDS - ENGINEERING]]> https://biospectrumindia.com/news/95/1965/trends-engineering.html https://biospectrumindia.com/news/95/1965/trends-engineering.html Wed, 19 Jan 2005 12:53:00 +0530 Bioengineering education perks up A scientist often solves problems to understand nature. An engineer usually undertakes tasks that need to be done in a specified period of time on a fixed budget and with limited resources. Larger the information an engineer has at command and larger his technical and social skills, the more likely he will be able to do his job quickly and efficiently. With the changing scenario, the role of technology is not limited to the production of man power for the organized industrial sector alone; it must also cater to the needs of the infrastructure and service sectors as well as the unorganized and rural sectors. The scope of enhancing productivity in these sectors by induction of improved technology is considerable. Some of the new emerging technologies such as information technology, communication technology, microelectronics, biotechnology and genetic engineering offer enormous scope for improving the efficiency of various types of production processes. To enhance the production in areas like vaccines and recombinant products, we require a strong skilled workforce with both scientific and engineering background. Engineering is a design-oriented activity and engineering design is the most important ingredient in the education and training of an engineer. It is design that distinguishes an engineer from a scientist. The government has taken up many steps to train students in engineering field so as to meet the requirements of the industry and to build a strong and self-sufficient India. "As against the regular courses, the engineering course in biotechnology helps the students to learn the basics of science and technology ie discovery to bulk production," observed Prof. R J Rayanade, Head of Department of Biotechnology Engineering, Kolhapur Institute of Technology's College of Engineering, Kolhapur. He further said that by virtue of their education, the chemical engineers are more diverted in their activities towards chemicals and they find it difficult to look into biologicals. The engineers with a biotechnology background will do justice to the job as they know the basics of science and also have the knowledge on technology and its applications. Biotech education in engineering colleges Out of 1,222 engineering colleges that got the All India Council for Technical Education (AICTE)'s approval to offer courses in science and technology, 133 colleges (i.e., approximately 9.5 percent of the total colleges) are offering biotechnology as one of the courses (for the academic year 2004-05). Taking into account at an average of 45 seats in each engineering college, as few colleges with a sanctioned intake of 30- 40-60, the total number of seats available to students in these 133 engineering colleges across India would be 5985. As per an estimate, the Visvesvaraiah Technological University, Belgaum in Karnataka alone is adding nearly 800 students in BE biotechnology a year. Besides we have many universities and leading technology institutions of India like Indian Institute of Technology offering BE/B Tech courses in Biotechnology. The Department of Biotechnology (DBT) has been supporting post-graduate teaching in biotechnology in universities. Currently, the DBT is supporting biotechnology studies in 30 universities in the country. DBT is supporting studies in agriculture biotechnology in seven universities, biochemical engineering studies in six universities and neuro-science, marine biotechnology, industrial biotechnology, pharma biotechnology and IPR studies in 10 universities. BT Engineering colleges   Tamil Nadu 34 (251) Andra Pradesh 24 (223) Karnataka 24 (112) Uttar Pradesh 10 (83) West Bengal 8 (52) Kerala 6 (82) Madhya Pradesh 5 (55) Haryana 5 (36) Rajasthan 4 (39) Maharashtra 4 (151) Note: (In the bracket the total number of engineering colleges in each state)   The biotechnology education in general and Bachelor of Engineering in biotechnology in particular has picked up in the last few years in states such as Tamil Nadu, Karnataka, Andhra Pradesh and Uttar Pradesh where we find the growth of biotechnology and more biotech companies have a base. Considering the government's initiative and positive attitude of the industry people, it is expected that more engineering colleges in states like West Bengal, Maharashtra, Punjab and Rajasthan would join the list of colleges offering biotech courses to meet the requirements of the industry. Considering the opportunity and growth of biotechnology in India like the Information Technology boom in the late 1980s, managements of many private engineering colleges would apply to get the approval from AICTE to offer biotechnology as one of the courses to their existing list. The biotechnology education requires high tech equipments to carry out the experiments at the lab level and also qualified and experienced teachers to train the younger generation. Barring a handful of colleges/universities, which got the recognition as the Center of Excellence and receive financial support from the University Grants Commission or from government agencies that these courses are run by institutions without adequate and appropriate facilities, in terms of class and lab space, lab equipment, library, adequately qualified teaching staff, etc., resulting in grossly underexposed and under-trained candidates. This certainly adds to fears. The AICTE has recently showed a red signal to one of the private engineering colleges in Tamil Nadu (Saraswathi Velu College of Engineering, Sholinghur) in Vellore district by withdrawing its approval for the college to start biotechnology courses. This was done to check the growth of engineering institutions that lack basic facilities and have no good teaching staff. In a way such steps from AICTE would only improve the standard of engineering education in biotechnology in the country. In some other engineering colleges it appears that the departments of chemical technology, wherever present, seem to stake claim to run the course in biotechnology, which is not in the interests of the course in the long run. With the lack of trained and experienced staff, who have a hands on industrial experience, most of the college are depending on temporary staff (the so-called guest or visiting faculty). This visiting faculty does most or all of the teaching in biotechnology departments. However, to overcome the lack of skilled and pool of talents, which is the need of the hour, Dr Vidita Vaidya of Tata Institute of Fundamental Research (TIFR) said, "Teaching should be encouraged at the research organizations. In this regard TIFR, a premier fundamental research organization in the country and a deemed university has already taken up an initiative." She also suggested for filling the gap that exists over the years between the industry and basic researchers/scientists. Dr Kameswara Rao, executive secretary, Foundation for Biotechnology Awareness and Education (FBAE) based at Banaglore observed in a document on 'The State of Biotechnology Education' the need for an establishment of a high-powered national statutory body, the Biotechnology Council of India, on the same lines as the AICTE, Medical Council, Dental Council, Pharmacy Council and the Bar Council that should have all the power to prescribe curricula and syllabi, standards of teaching facilities, qualifications of teachers and their emoluments, regulate fee structure and decide on all matters related to education and training in biotechnology in the country, and to affiliate or disaffiliate institutions. However, Dr Dhananjay Patankar, head, biotechnology, Intas Pharmaceuticals Ltd, Ahmedabad maintained, "We are happy with the students of University Institute of Chemical Technology (UICT), Mumbai where we conduct campus interviews." Intas Pharma used to recruit 3-4 freshers every year from this UICT that is strong on the biochemistry front. Needs of the industry The industry needs people appropriately trained in biotechnology and not mere degree holders. With changing scenario, most of the colleges/universities are preparing need- based syllabus with focus on application of science and technology, instead of focusing on providing a strong foundation in basics which will prove to support the students in understanding various topics in biotechnology even at later stage. "Yes to some extent the industry need-based approach may create a problem for the students in the long run, "said Prof. Rayanade of Kolhapur Institute of Technology's College of Engineering. The efforts in capacity building in biotechnology will not serve by enormous enrolment, which will only kill the prospects of meaningful education in the area and ruin careers. It is unethical to allow hype to build up in education to foster moneymaking organizations, in the name of service to education. Once the hype recedes, the whole system collapses, severely damaging the county's interests. "As the industry is small and very capital intensive, the demand is not much. To be very honest, the flow of talent in biotechnology space is more against the industry demand. Companies like Ranbaxy, a leading pharmaceutical company in India is recruiting handful of candidates/freshers. The companies look at experienced candidates. In few years we will find a lot of biotechnology graduates without jobs. Hence the authorities in AICTE should look at the issue and have to put a check on giving permission to more number of colleges. To overcome the hype, Kolhapur Institute of Technology's College of Engineering, one of the four engineering colleges offering biotechnology in Maharashtra is having three types of students. First type are those who look for higher education, second â€“ those who opt for jobs immediately after coming out from the colleges due to the poor financial status of the families and finally the third type who are looking at becoming entrepreneurs. Besides providing the basics of biotechnology, the institutions should look at developing the technical skills of the students. This can be done by entering into tie-ups with companies and leading research organizations of the country like Indian Institute of Technology, Kharagpur. Department of Biotechnology sponsored programs* Indian Institute of Technology, Kharagpur 1986-87 Indian Institute of Technology, New Delhi 1986-87 Anna University, Chennai 1991-92 University Institute of Chemical Technology, Mumbai formerly UDCT 1993-94 West Bengal University of Technology, Kolkata 2002-03 Indian Institute of Technology, Kanpur 2002-03 National Institute of Pharmaceutical Education & Research Mohali (M Tech Pharmaceutical Biotechnology - 2-year course) 2003-04 *Programs include B Tech /M Tech in biochemcial engineering and biotechnology (five-year integrated or four-semesters or two-year courses)   The Department of Biotechnology and Biochemical Engineering at Indian Institute of Technology, Kharagpur, which was started in 1986 with the grants from Ministry of Human Resources Development and offering B Tech (honorary) courses in biotechnology and biochemical engineering (4 years) and B Tech (honorary) and M Tech in biotechnology and biochemical engineering (five years) integrated courses has already engaged in collaborative projects with leading companies like Hindustan Lever, Bangalore, Tata Tea, Kolkata, AMS Baeshen, Saudi Arabia, Bharat Serums & Vaccines, Mumbai, Tarson Products, Kolkata and has been involved in different research areas like Biochemical Engineering, Environmental Biotechnology, Enzyme and Lectin Biotechnology, Genetics, Immunology and Molecular Biology, Microbial Biotechnology, Microbial and Plant Biotechnology, Virology and Molecular Biology, Structural Biology, Biochemical and Bioprocess Engineering. Quality education The economic progress of a country is strongly linked to the quality of education. It is therefore, necessary to undertake periodic review of the curriculum and subject content of the technical programs to ensure that they are up to date not outmoded or obsolete and effectively fulfil the technological requirements of the country. Steps like setting up an expert panel by DBT under the leadership of Prof. A S Kolaskar, vice chancellor, University of Pune to look into the human resources development required for the biotechnology industry have been taken to improve the quality of technical education. The other steps to be taken include evolution of model syllabi, quality improvement programs for teachers; encouraging interaction with industry through consultancy and continuing education programs; and providing impetus for expanding infra-structural facilities in emerging technologies. To make the Indian biotech industry internationally competitive, the frontier technologies have to flow from the R&D institutions to the industries and also be continually infused in the engineering curriculum. Thus, it is pertinent that educational institutions, industries, and research institutions which are at the three vertices of a triangle should converge at some nucleus through coordinated research in both conventional and emerging fields catering to the need of the industry, which will be transferred to the industry and also amalgamated in the engineering curricula. Narayan Kulkarni   ]]> <![CDATA[Trends - Private Institutes]]> https://biospectrumindia.com/news/95/2764/trends-private-institutes.html https://biospectrumindia.com/news/95/2764/trends-private-institutes.html Wed, 19 Jan 2005 12:49:00 +0530 "There is always a question of Equity Vs Excellence and Quality Vs Quantity" Dr Sunil Saran of Amity Institute of Biotechnonlogy explains about the initiatives that the institute has taken to foster better biotech education in the country. Private universities have come in for a lot of criticism from the academicians. Why? Private universities are primarily criticized for the fact that they charge huge fees from the students. Whenever this issue is raised, there is always a question of Equity Vs Excellence and Quality Vs Quantity. What many do not realize is that we provide excellent laboratory and library facilities to the students without any infrastructure or teaching support from the government. We, at Amity have eight former VCs as part of the faculty. And we have opened branches in Jaipur and Lucknow, which we are running on our own. This speaks about the quality of our education. People who criticize private universities should come out with concrete reasons. I know of universities under the UGC, where 180 days of teaching is mandated, but hardly 60 days of teaching takes place or universities which have not revised their course syllabus since the past 30 years. At the same time there may be private institutes, which are fleecing students and not providing quality education. What are the strengths of Amity in the area of biotechnology? Amity was amongst the first to introduce a BSc honors program in Biotechnology in the country. We have included modern areas like genomics, proteomics and bioinformatics in the course syllabus, the idea being to catch students young in any thrust area. In 2002, two of Amity schools, one each in Delhi and Noida were chosen to introduce biotechnology at the 10+2 level. We have a four-year B Tech biotechnology and a B Tech Bioinformatics course. This year we are introducing a 4-year BSc honors course program in medical biotechnology. At the master's level, we are the only university after Pune University to introduce a course in MBA biotechnology. This course has a special thrust on industrial training and will focus on laws related to biotech, finance, HR development and marketing. Every year our results have been 100 percent. And four of our BSc students have been admitted directly to MS biotechnology course in the University of Abertay, Dundee in Scotland. Two students have been admitted to the Madurai Kamaraj University, while two have been selected by AIIMS and about 20-25 students have gone abroad for higher studies. Our infrastructure and lab skills are well developed and we subscribe to many international journals for the library. Today the shelflife of any knowledge is just three years and we keep on upgrading our courses. Recently, the government of Kerala has given us a mandate for setting up an Amity Biotech industrial park in the state, institutions of excellence in biotechnology, nanotechnology and nanobiotechnology and centers for R&D in biotechnology, marine biotechnology, and health tourism. There are also plans for setting up a center for genetics and genomics on an area of 200 acres in the state. A task force has been constituted with seven members each from the Kerala government and Amity. "Excellent industry interaction gets applied research projects." DA Prasanna, executive chairman, Manipal Education & Medical group â€¢ Excellent industry interaction gets applied research projects. In a big company if 4-5 PhDs work on a project then it generates a talent pool in that area. And excellent peer interaction between national and international universities creates a "basic research scientific network". In the clinical area, we should network with medical school for patient and clinicians. â€¢ Apply faculty, scientists, investigators to an industry project and then look for funding. At Manipal we have created a research community and networked extensively. We have access to ICMR, DBT DST and NIH grants. The Manipal University provides a pipeline of bright innovative health sciences talent. â€¢ We have tie-ups with the national labs like NCBS and CDFD for PhDs. For international research we have tie ups with universities like the Purdue and Harvard. In association with Harvard, research is being carried out on stem cells and therapeutics. We have established a CoE in Pharmacogenomics with the help of a DST grant of Rs 6.5 crore. In a year, we produce seven global patents and 20 PhDs. â€¢ We should provide industry relevant training. Today 61 plants take up contract manufacturing for the US market. Manipal in association with the Purdue University offers a one year diploma in cGMP training. â€¢ The industry on its part should fund research in universities so that academics can make progress by building networks with medical schools and national labs. "Private universities are tech driven and have a very vigorous interaction with the industry" Dr PK Paul, Associate Dean, Bioengineering and research center, Rai University speaks about the need and relevance of the private universities in the country. It is not that the biotech education in the country in now a domain of the government-aided schools. Several private educational institutes have stepped up their efforts in imparting biotech education. There may be the argument that everybody (both private and public institutions) today is offering biotech courses; that these courses are becoming a fad; that institutions are not having the necessary infrastructure to deliver the biotech programmes; that the syllabi is not in sync with the industry's requirement, etc. True and several private institutes have chosen the path to fill in some of the gaps that exist. They have chosen the path of increasingly being closer to the industry. Their preference has been to align closely with the requirements of the industry and tune the courses in that direction. Besides they have also chosen to focus on the placements. According to DA Prasanna, executive chairman, Manipal Education & Medical group, close industry interaction gets applied research projects. He believes if in a big company 4-5 PhDs work on a project, it then generates a talent pool in that area. And excellent peer interaction between national and international universities creates a "basic research scientific network". This has worked at Manipal. Our survey shows that out of the total Top 20 institutes ranked on placement records, 12 are from the private domain. Only eight are public institutes. The private institutions are stepping up their activities. Do you think that private universities are here to stay? Private universities offering biotech courses are a growing trend because, after all, how many students can the government institutes accommodate? Especially now, when a very high number of students after 10+2 want to pursue biotechnology. Here, private universities provide an alternate avenue. Private universities are very competitive and serious in their focus. The private universities are tech driven and have a very vigorous interaction with the society and the industry. I think that everything will go well if the quality of teaching is maintained in an institute. What are your strengths vis a vis a traditional university? Our success over a traditional university is in the library, laboratory infrastructure and an industry driven course curriculum. Biotechnology requires heavy infrastructure and investment both in terms of laboratory and library. The initial investment goes upto Rs 90 lakh to Rs 1 crore. And we are in a position to invest that kind of money. Also, private universities are very flexible in terms of their course curriculum. The university-industry interaction is very high. In consultation with the industry, we modify the course content taught. We have an ongoing process of curriculum development and in a way our curriculum is ahead of that in many institutes. In a traditional university a syllabus change requires more than 2 years and by then it becomes irrelevant to the industry. Third we have a placement cell and are committed to place our students in the industry. Right from the third semester onwards, we start the exercise of CV preparation. We are also interacting with the Biotech Consortium of Indian Limited (BCIL) as they too run a training and placement program for biotechnology students. ]]> <![CDATA[TRENDS - BIOTECH EDUCATION]]> https://biospectrumindia.com/news/95/1690/trends-biotech-education.html https://biospectrumindia.com/news/95/1690/trends-biotech-education.html Wed, 19 Jan 2005 12:43:00 +0530 Fostering biotech education Post graduates, doctorates and post doctorate research fellows are the key talent for research in any area requiring intensive scientific knowledge and development. A look into how this talent is being nurtured in the universities and institutes offering biotech education in the country. Biotechnology education in the country has received great impetus and support first from the National Biotechnology Development Board and then from the Department of Biotechnology (DBT). The National Biotechnology Development Board was established in 1982 and its very first mandate was human resources development as biotechnology is a very specialized domain and a very knowledge intensive field; development of infrastructure facilities; and to support R&D. The DBT Thrust Later, with the establishment of the DBT within the ministry of Science & Technology in 1986, this mandate was taken over by this Department. And to date there are about 70 courses being supported by DBT across the country. Initially biotechnology-teaching courses were introduced at the Masters level in universities like Madurai Kamaraj University, Jawaharlal Nehru University and the Pune University. Subsequently, the course was introduced in other universities. Today most of the universities, agricultural universities and even the Indian Institutes of Technology have introduced biotech courses across the country. They have not only gained acceptance at the master's level, but are also considered as one of the best courses being run in the country. The annual budget of DBT for human resources development is Rs 10-15 crore. And to start a course in a university, it grants about Rs 1-1.5 crore for setting up the initial infrastructure and then the recurring support is about Rs 25 lakh. The total intake of students in the various DBT supported postgraduate courses is around 840 per year. "Biotechnology is a quantitative subject and a biotechnologist is like a mathematician" Dr Krishnamoorthy Kannan, professor, School of Biotechnology, Guru Govind Singh Indraprastha University, Delhi What is your perception about biotech as a subject? Unfortunately, nowadays, biotechnology has become an extension of biology. So every biologist thinks that he is a biotechnologist. Hence, we are teaching it as a bioscience subject rather than as a technology subject. And the faculty teaching biosciences does not leave affiliation to their parent subject. Today, biotechnology needs a new definition. According to me, it is a quantitative subject and a biotechnologist is like a mathematician who does addition, subtraction, multiplication and division of bimolecular in a cell to make useful products for mankind. When one understands this philosophy behind the subject, then one is on a new plane to talk in integrated terms and "classicism" of the various subjects (biochemistry, microbiology, biochemical engineering) is done away with. Today there is a conflict of qualitative vs. quantitative science-Biosciences vs. biotechnology, resulting in a serious issue of identity crisis. What do you feel about the biotech education being imparted in India? The present 2-year masters program cannot teach technology in such a short span. It requires a 4-5 year course program, as it involves a whole gamut of subjects like IPR issues, marketing, biomanufacturing, biosafety, bioethics, strategic management, product formulation, clinical trials, etc. Biotech education should be structured just like that of the IITs, which take students after 10+2 to teach them the engineering technology. Actually a biotechnologist is like an IAS officer whose main function should be to know the roadmap of metabolic synthesis and the systems biology. The social impact of the subject is equally important, as finally, it should be an equilibrium process. The risk benefit analysis should be a part of the technology course. Should students be given training in the industry for better orientation? The industry is not the ideal training ground, as it follows a strict time-scheduled program. There every product has to be developed yesterday, everything is fixed and set and secrecy is important and children are not geared for that kind of training. We need to impart training in a way like the Bhabha Research Center (BRC), where every person needs to undergo training for about a year before induction in the institute. We need an incubation facility to train and orient students and need multi-dimensional people having both the industry and academic orientation to run it. Industrial training should be run as a separate course like the MBA program, which trains people for the industry. But the gap remains... With the thrust from DBT, the number of students wanting to pursue biotech education remains very large. Of the more than 17,000 applications received for the joint biotechnology entrance exam conducted by JNU in 2003-04, only 471 students were selected across 28 universities. In JNU, itself out of the over 9,000 applications received only 30 students were taken in during the last academic year. Similarly for the PhD program last year, out of the 1,500 direct applications received, only six were selected. In the Net/GATE qualified category, of the 74 applicants, 12 were offered a seat and in the experienced and service category (Direct Entry) of the 40 applicants, none was taken in. A similar trend was seen in the other top universities in the country. Granted that of the many applications received a sizeable number will not have the aptitude for this specialized course but even then a large chunk of the students remain, who are desirous of studying biotechnology in the prestigious universities of the country. HRD plan being mooted Looking at the urgent need for a comprehensive HRD plan in the present situation or else, there would be a mismatch between the increasing number of students graduating from universities and the employment opportunities, the Department of Biotechnology (DBT) has constituted an expert panel, headed by Prof A S Kolaskar, vice-chancellor of Pune University to formulate a comprehensive plan for human resources development in the sector, keeping in view the demand and employment opportunities in the country. The panel is also expected to assess the manpower requirement in relation to the global trends of the biotechnology industry. It will also assess the current capacity available in the country for teaching and research. Among the panel members are Prof A R Thakur, vice-chancellor, West Bengal University of Technology, Kolkata; Prof Akhilesh Tyagi and Dr Vijay Chaudhary of Delhi University; Dr G K Garg, GB Pant University, Pant Nagar; Dr G S Bhubaneswar, SCTIMST, Thirivananthapuram; Dr Saroj Mishra, Indian Institute of Technology, Delhi; Aseem Chauhan of Amity University, Delhi; Raju Barwale of Mahyco-Monsanto Biotech Company; Dr M Vidyasagar, Tata Consultancy Services; Dr Villoo Patel, Avesthagen Ltd, Bangalore; Dr Krisha Ella, Bharat Biotech; Dr S Balamanian, Reametrix Inc, USA; Dr Vijay Chandru, Strand Genomics. Other members are from the Union HRD ministry, University Grants Commission, All India Council of Technical Education and apex industry bodies like the Federation of Indian Chambers of Commerce & Industry (FICCI) and Confederation of Indian Industry (CII). The joint secretary in DBT is also a member of the panel. The DBT director, SL Govindwar, is the member-secretary of the panel. Quality of education The standard of the biotech education being imparted in the DBT-supported courses is very good. This can be judged from the fact that about 92 percent of the student toppers in the NET, UGC and GATE are from the biotechnology stream. Most of the top universities adhere to the standard course outline, which the institutes try to continuously evolve at their end. But many a times due to the bureaucratic processes involved, it is difficult to update the courses at regular intervals. This problem is much more widespread in the associated courses of biochemistry, microbiology, etc. "In India the problem is that though in the entire country there are at present 20-25 universities offering biochemistry courses, there is no uniformity in the syllabus taught. The syllabus is oriented by the faculty, resources and the infrastructure available," said Prof. Prahalad C Ghosh, dean and head, Department of Biochemistry, University of Delhi, South Campus. "This can be done away with by inter-university teaching and inter-department cooperation which will benefit the students," he added. Another key issue affecting the quality of education is the infrastructure and practical oriented teaching. MSc biotechnology is very application oriented and the infrastructure has to be good for practical training, as research skills evolve in parallel with teaching. Almost all faculty members of the top universities have a few projects running and so there is a lot of practical exposure for the students. Research work and quality of dissertation is greatly emphasized upon. It is the upcoming institutes, mediocre universities that face this problem most often. The practical aspects are lacking from the grassroot level and at the graduation level there is not much emphasis on practical education in most of such institutes. For project finding, the trend of solely depending on the government funding bodies like the DBT, DST, CSIR is passÃ©, the academia should come up with innovative ideas and tap the industry for funds. Lastly, there is interdependency between faculty and students. Excellent faculty attracts bright students as again witnessed in top institutes. Most of their faculty members have 20-30 years of experience with good projects running under them. "While recruiting for faculty we have to be more diverse, broadminded and see which of the areas/fields are experiencing shortage. We should not support inbreeding which is rampant nowadays," said Prof Ghosh. "Integrative teaching is a new model of Education" Sameer Brahmachari, director, Institute of Genomics and Integrative Biology (IGIB) Will the present education model suit the current changing times? Our present education system at the high school level or at the university level completely lacks innovative approach or inventive thinking. Prior to the Internet era, we needed information. So imparting education meant being informed. But now gathering information is no longer the objective of education. Now, we need to train people only to think and to innovate. And that is the role of a teacher and university system. Our present education system, whether it is CBSE board, ICSE board, University board or University Grants Commission, is obsolete for tomorrow's education. We need new approaches for learning. All countries like Singapore, Europe, US, Germany have floated, what you call, integrative courses. In these courses trans disciplinary subjects are taught together for problem solving. Integrative teaching is a new model where dis-coordinated information is given and students have to synthesize information, to integrate the knowledge to create new knowledge, new information or new conclusion. This cuts across the subjects and orients the students for information processing in biology. How can it be achieved? It is not possible in the present structured system. We need an unstructured system. At IGIB, we have taken in students from the so-called microbiology, biochemistry, structured disciplines and put them through an integrated course that we have created. We have started this experiment with 20 students, whom we are exposing to this course. They all are PhD students and our objective is to reorient them. They have to unlearn something and relearn a few things. We are not new in introducing this concept. This October, in the US, several universities have started courses in integrative biology. Integrative courses have become a direction for Harvard, MIT because the drug and pharma industry has realized that we are not creating individuals who understand things holistically. I believe that the national laboratory resource can play a very important role in this direction. They can be used to create research universities, where learning is through discovery. I do not find any reason as to why the masters degree should be only through a written exam. Why the masters degree cannot be part of a bigger assignment. Every national laboratory should award MSc degrees by research. And thereby one can empower a huge number of trained manpower very fast. What is the role that national laboratories can play? By empowering the national labs, we can increase by four times our present research capacity. We can immediately create 300 percent more trained manpower without spending more money. Wherever the university has taken advantage of the national laboratory, they have been able to attract very good students. But unfortunately very few university departments consider national labs as partners. They have an inferiority complex of national labs. Most of the universities propagate mediocrity. And mediocrity has a fear of interacting with excellence. We promote and propagate mediocrity. And mediocrity protects them. That is why some of our universities are so bad. There are so many university professors, who get in their credit, papers and PhD students, whose face they have not seen because they have just lend their name to be a registered PhD, whereas the student works in some national laboratory. And this is the highest academic corruption prevalent in the country. We must remove the so-called divide between the national laboratories and the universities. While on one hand we are allowing very mundane small institutes to become deemed universities, we need the national labs to play a very major role in human resource development shoulder to shoulder, with the UGC. To create 500 percent growth in high tech manpower, if India has to face the challenge post WTO. Centers of Excellence The culture of the DBT supported courses gave a huge impetus to the human resource generation, which fueled research in the country. According to estimates approximately about 20 percent of the initial human resources generated were going into research, which is huge! And earlier a big percentage of this group was going abroad to National Institute of Health (NIHs). Agrees Dr Arun Balakrishnan, director, Center for Biotechnology, Anna University. Several of his institute's students are abroad. But now this trend is seeing a change. Now many researchers are looking towards and are being absorbed by the National Centers of Excellence (CoEs) like the National Brain Research Centre (NBRC), National Institute of Immunology (NII), National Centre for Plant Genome Research, Institute of Genomics and Integrative Biology (IGIB), National Centre for Cell Science (NCCS), etc. These CoEs were established not only to promote research in specific areas (Brain, Cell Culture, Plant Genomics) but also keeping the socio economic problems and the question of job opportunities in purview. This is akin to something like what China has done. They have created institutes across the country, which have been able to absorb their trained researchers from within the country and those coming from abroad. A very remarkable effort but unfortunately this takes care of a very small fraction of the Indian research community. Post doctorate culture Most of the students, about 90 percent, of good universities like the JNU and Delhi University go for higher research. And a sizeable number of them go abroad for higher studies. But then what are the options for the large number of doctorate degree holders left in India? The Government institutes are not big hirers - they only provide temporary jobs. And the biotech industry is still in a nascent stage. The county does not have a very strong post doctorate culture. For example, the present research associateship is for two years and the scale is just Rs 13,000. So this has become just a time gap arrangement between jobs and PhDs. Said Prof. RK Saxena, head, Department of Microbiology, University of Delhi, South Campus, "Indian Science is totally dependent on PhD students. And that is the reason why we produce so many PhDs. The Indian science managers should develop a good culture in terms of the post Doc's status (emolument-wise on a contract basis) and account for their seniority level as well. To a large extent, these problems are responsible for the dwindling number and quality of scientists in the last 25 years. Compared to 32 percent students pursuing science in the 1950s, today only 15 percent of students are pursuing sciences now. "Molecular biology is in a typical 'Catch 22' situation" Dr GK Garg, Dean of the Basic Sciences College and Head of the Molecular Biology Department, The Govind Ballabh Pant University of Agriculture and Technology, Pantnagar, There are apprehensions amongst the prospective biotech professionals about their finding suitable avenues in the industry. Your comments. Adequate trained manpower is absolutely essential for the development of the industry. But today since the field is still nascent, so it does not have a very large absorption capacity. Later when the industry matures, there will be an acute lack of qualified professionals. So at present the field of molecular biology is in a typical "Catch 22" situation. First of all awareness about biotechnology and its potentials is essential, then adequate trained quality manpower is needed and then we need to set the targets. Even today, in this area, we are dependent on technology from outside. In the industry the R&D skills have not been traditionally strong. And they found the fastest way was to import the technology. And now with the Product-patent regime coming up, if we need to develop a process or a product, it brings us to square one. We need to develop both techniques at the lab level, which can translate into technology for the industry. And for this associate manpower is necessary. Even if we have to import technology we have to be very focused. It is just like the automobile industry in India, where at one time we did not have any indigenous cars, then we were able to make develop a indigenous industry through foreign collaborations and tie ups. Same should be the case in biotechnology. We need to develop a long-term vision. Like in the area of medicinal plants there is a lot of scope for isolation of medicinal components, neutraceuticals, development of ethnic food and food related technologies. What is the significant gap in the efforts made for the development of the biotech field? The field is coming up. Though attempts have been made but there is a need for planned effort. A consortium of academia, industry and the government is needed to spearhead the effort. We do keep making vision papers but they are not very precise. They just state what we wish to do. We need to come up with precise action plans with liaison at the state and the national level in the interest of the country. See, for example, in the pharma industry, biotech applications are doing so well - Shantha Biotech is making recombinant vaccines; Biocon is into recombinant enzymes. Similar will be the case in agricultural biotechnology in a few years from now. How do you view the trend of Indian researchers working abroad? Today in modern biology the trend in exporting your training is following the same trend as in the sector of information technology. There was a lot of Indian talent going abroad in IT and then the trend got reversed. Similar reversal will happen in the case of modern biology. This is just a transient stage. I feel that even if our students are going abroad, it is not a big issue. We are still getting tremendous returns, as we are able to get their help with increasing globalization. Also, many people of our generation, who received extensive training abroad, came back to India, then should the US also cry about brain drain? Today in the field of medicine and IT, India's skills are recognized. We have excellent trained doctors and people from abroad are coming to India for treatment. I predict a similar future in biotechnology a few years from now. Why is the industry-academia interaction not really taking off? The problem lies with both the industry and academia. Although a lot of it is talked about in various forums, most of it remains on paper. The academia perceives the industry with a huge bag of money, which will give them lots of grants. And the industry wants to take in the R&D, which is already done. So there has never been a good match. A good model can be Japan where real partnerships take place between the industry and the universities. First a research is done on what will be the requirements ten years hence in the field, it is visualized and then the industry picks on people with specific skills to provide solutions in that field. This is a good model of industry academia interaction. Actually, the industry need not set up a very elaborate R&D center; they can in turn liaison with those having the infrastructure. For example, in Pantnagar, we are actively looking at partnering with the Tatas in the field of agricultural research. An advanced scientific center is proposed to be set up in the university campus with Tata Chemicals. This advisory body of the center consisting of scientific experts and trustees of Tata Chemicals, will examine and screen proposals/projects having innovative ideas and a potential for commercialization. The project will be funded by the Tatas. The important point here is that the industry is using the university as a vehicle for higher research rather than setting up its own R&D infrastructure or funding a few projects on an ad hoc basis. This is a new concept. Revamping higher education Restructuring and revamping the higher education system was frequently suggested in our interaction by top academicians. According to Prof Deepak Pental, Director, Delhi University, South Campus, "The education system has to be completely revamped. We should have B Tech degrees in agricultural biotechnology, which should be offered in 5 universities to start with. IARI should take the lead. We should teach plant biochemistry, mapping techniques, etc and should have a strong field working environment." Across the world, in universities, the academic courses have been restructured. Like in Oxford, courses like Organic chemistry, Inorganic chemistry and Physical chemistry have been done away with long back and now courses like Chemical biology, Bioorganic chemistry have been introduced. The idea being that courses need to retain the scientific vigor but should become interdisciplinary in approach and applied in nature. "We need to work with academics and national labs on projects not on a contract basis but as stakeholders. We have a foundational weakness. We have to think above disciplines and do qualitative thinking," said Dr T Balganesh, Vice President, Head of Research, Astra Zeneca Pharma India Ltd. Even our ministers have made a note of things. In a recently held CII meet on "Building Innovative Pharma in India", Kapil Sibal, the minister for science and technology, said Higher education be dealt in a manner different from the past. Higher education is the raw material that will be serving the industry tomorrow. Industry should take the lead and interact with the academicians and politicians and tell them about their requirements."   ]]> <![CDATA[Universities]]> https://biospectrumindia.com/news/95/2187/universities.html https://biospectrumindia.com/news/95/2187/universities.html Wed, 19 Jan 2005 12:42:00 +0530 Important Research institutes and Universities offering Biotechnology Courses Andhra Pradesh Acharya NG Ranga Agricultural University Rajendranagar, Hyderabad - 500 030 Tel.: (040) 24015161 Website: www.angrau.net Andhra University Waltair, Visakhapatnam - 530 003, Andhra Pradesh Tel.: (0891) 555547 Center for DNA Fingerprinting and Diagnostics Laboratory Hyderabad - 500 076 Tel: (040) 7155481 Website: www.cdfd.org.in Central Research Institute for Dryland Agriculture Hyderabad - 500 659 Tel: (040) 24530177/24530161 Website: www.dryland.ap.nic.in Central Tobacco Research Institute Rajahmundry - 533 105 Tel: (040) 2465995/2471871 Directorate of Oilseed Research Rajendranagar, Hyderabad - 500 030 Tel: (040) 24015344 Website: www.dor-icar.org Directorate of Rice Research Rajendranagar, Hyderabad - 500 030 Tel.: (040) 4015036-39 Website: http://dare.nic.in/drr.htm Jawaharlal Nehru Technological University Kulkatpally, Hyderabad - 500 072 Tel.: (040) 3158661-4 Website: www.jntu.ac.in Kakatiya University Vidyaranyapuri, Warangal - 506 009 Tel.: (08712) 38001/77101-03 Website: www.kuwarangal.com National Institute of Nutrition Jamai-Osmania PO, Hyderabad - 500 007 Tel.: (040) 2868909 Website: www.icmr.nic.in Osmania University Administrative bldg, Hyderabad - 500 007 Tel.: (040) 27098048/27098088 Website: www.osmania.ac.in/ Sri Krishnadevaraya University Sri Venkateshwarapuram, Anantapur - 515 003 Tel.: (08554) 255231/255294 Website: www.skuniv.ap.nic.in Sri Venkateswara University Tirupati, Chittor - 517 502 Tel.: (08574) 49727/49666 Website: www.svuni.ap.nic.in University of Health Sciences Vijayawad - 520 008 Tel.: (0866) 477206-10 Assam Assam Agricultural University Jorhat - 785 013 Tel.: (0376) 340097, Website: www.aau.ac.in Gauhati University Gopinath Bordoloi Nagar, Guwahati - 781 014 Tel.: (0361) 570415/570412 Website: www.gu.nic.in Indian Institute of Technology Institution of Engineers Building, Panbazaar, Guwahati - 781 001 Tel.: (0361) 790321-8 Course: BTech Biotechnology Website: www.iitg.ernet.in Bihar LN Mithila University Kameshwarnagar, Darbhanga - 846 008 Tel.: (06272) 22428/22463 Patna University Patna - 800 005 Tel.: (0612) 670531 Chattisgarh Guru Ghasidas University PO Koni, Bilaspur - 495 009, Chhatisgarh Tel.: (07752) 40784/72549 Pandit Ravishankar Shukla University Raipur-492 010, Chhattisgarh Ph: (0771) 262540 Website: www.rsuniversity.com Delhi All India Institute of Medical Sciences Ansari Nagar, New Delhi - 110 029 Tel.: (011) 26588500/26588700/26589900 Website: http://www.aiims.ac.in Guru Gobind Singh Indraprastha University Kashmere Gate, Delhi - 110 006 Tel.: (011) 2969313/3863536 Website: www.ggsipu.nic.in Indian Agriculture Research Institute New Delhi â€“ 110 012 Tel.: (011) 25843375/25853367 Website: www.iari.res.in Indian Institute of Technology Hauz Khas, New Delhi - 110 016 Tel.: (011) 26967696/26861977 Website: www.iitd.ernet.in International Centre for Genetic Engineering and Biotechnology New Delhi Tel.: (011) 26189358 Website: www.icgeb.res.in Jamia Hamdard Hamdard Nagar, New Delhi -110 062 Tel.: (011) 26084685/26089688 Website: www.jamiahamdard.edu Jamia Millia Islamia Mohammad Ali Jauhar Marg, Jamia Nagar, New Delhi - 110 025 Tel.: (011) 26831717/26835176/26835315 Website: www.jmi.nic.in National Brain Research Centre New Delhi Tel.: (0124) 2338922-26 Website: http://www.nbrc.ac.in/ National Bureau of Plant Genetic Resources New Delhi - 110 012 Tel.: (011) 25843697 Website: www.icar.org.in National Centre of Plant Genome Research New Delhi Website: http://dbtindia.nic.in/institutions/ncpgr.html National Institute of Communicable Diseases New Delhi Website: http://mohfw.nic.in/kk/95/ib/95ib0k01.htm National Institute of Immunology Aruna Asif Ali Marg, New Delhi - 110 067 Tel.: (011) 26105001 Website: www.nii.res.in Rai University A-41, MCIE, Mathura Road, New Delhi - 110 044 Tel.: (011) 51560000/51570000/26959000 Course: BSc Biotechnology, MSc Biotechnology, MSc Bioinformatics Website: www.raiuniversity.edu Haryana Kurukshetra University Kurukshetra -136 119 Tel.: (01744) 238039/238417 Website: www.kuk.ernet.in National Dairy Research Institute Karnal - 132 001 Tel.: (0184) 2252800/2259002 Website: http://karnal.nic.in/res_ndri.asp Himachal Pradesh Central Research Institute Kasauli Website: http://mohfw.nic.in/kk/95/ib/95ib0q01.htm Jharkhand Birsa Agricultural University Kanke, Ranchi - 834 006 Tel.: (0651) 455073/455850 Website: www.icar.org.in/birsa/BAU.htm Karnataka Bangalore University Jnana Bharathi, Bangalore - 560 056 Tel.: (080) 22211792 Center for Human Genetics Bangalore - 560 066 Specialization: Genome research Indian Institute of Horticultural Research Bangalore - 560 080 Website: http://www.iasri.res.in/inaris/iihr.html Indian Institute of Science Bangalore - 560 012 Tel.: (080) 23601219/23600416 Website: www.iisc.ernet.in Jawaharlal Nehru Centre for Advanced Scientific Research Jakkur, Bangalore - 560 064 Tel.: (080) 8462750-57 Website: http://www.jncasr.ac.in/contact.html Karnatak University Pavate Nagar, Dharwad - 580 003 Tel.: (0836) 2448600 Website: www.nitpu3.kar.nic.in Karnataka State Sericulture Development Institute Thalaghttapura, Banglore - 560 002 Manipal Academy of Higher Education University Building, Madhav Nagar, Manipal - 576 119 Tel.: (08252) 2571201 Website: www.manipal.edu National Institute of Mental Health and Neuro Sciences PB No. 2900, Bangalore - 560 029 Tel.: (080) 26564140/26561811 Website: http://www.nimhans.kar.nic.in/ University of Agricultural Sciences Gandhi Krishi Vignana Kendra Campus, Bangalore - 560 065 Tel.: (080) 23330153-62 Website: www.uasbng.kar.nic.in Kashmir University of Kashmir Srinagar - 190 006, Jammu & Kashmir Tel.: (0194) 429405 Kerala Central Institute of Fisheries Technology Willingdon Island, Matysapuri, Cochin - 682 029 Website:www.indian-ocean.org Central Plantation Crop Research Institute Kasaragod - 671 124 Tel.: (04994) 232894-6 Website: http://cpcri.nic.in Central Tuber Crops Research Institute Thiruvananthapuram - 695 017 Tel.: (0471) 2598551 Website: http://www.ctcri.org/ Indian Institute of Spice Research Calicut - 673 012 Tel.: (0495) 2731346 Website: http://www.iisr.org/ Marine Products Export Development Authority MG Road, Cochin - 682 016 Tel.: (0484) 311979/311803 Website:www.mpeda.com/ Rajiv Gandhi Centre for Biotechnology Thiruvananthapuram - 695 014 Tel.: (0471) 2341716/2347975 Website: http://www.rgcb.res.in/ Sentinel Surveillance Center for Tuberculosis 130, Kerala Agricultural University, Trichur â€“ 680 654 University of Kerala University PO, Thiruvananthapuram - 695 034 Tel.: (0471) 306634/305726 Website: ww.keralauniversity.edu Madhya Pradesh Awadesh Pratap Singh University Rewa - 486 003 Tel.: (07662) 51519/50050 Barkatullah Vishwavidyalaya Hoshangabad Road, Bhopal - 462026 Tel.: (0755) 587236/290671 Doctor Harisingh Gour Vishwavidyalaya Gour Nagar, Sagar - 470 003 Tel.: (07582) 22574/22475 Jiwaji University Vidya Vihar, Gwalior - 474 001 Tel.: (0751) 341896/341348 Website: www.jiwaji.edu Maharashtra Agharkar Research Institute Gopal Ganesh Agarkar Road, Pune - 411 004 Tel.: (020) 2654357/25653680 Website:www.aripune.org/ Amravati University Tapowan Road Camp, Amravati - 444 602 Tel.: (0721) 662373/662206-8 Website: www.amtuni.com Bhabha Atomic Research Center Trombay, Mumbai - 400 085 Tel.: (022) 25505050/25505010 Website:www.barc.ernet.in/ Cancer Research Institute Tata Memorial Center, Parel, Mumbai - 400 012 Tel.: (022) 24123803 Website: http://icmr.nic.in/cancer.pdf Dr BR Ambedkar Marathwada University University Campus, Aurangabad - 431 004 Tel.: 334431-37 Indian Institute of Technology Powai, Mumbai - 400 076 Tel.: (022) 25767771 Course: MSc Biotechnology Website: www.iitb.ernet.in Institute of Chemical Technology Mumbai University, Nathalal Parikh Marg, Matunga, Mumbai - 400019 Tel.: (022) 24145616 Website:www.udct.org/info National AIDS Research Institute 73, G-block, MIDC, Bhosari, Pune - 411 026 Tel.: (020) 27121072 Website: http://icmr.nic.in/pinstitute/nari.htm National Center for Cell Science University of Pune Campus, Ganesh Khund, Pune - 411 007 Tel.: (020) 25690922/25690931 Website:www.nccs.res.in/ National Institute of Virology 20A, Dr Ambedkar Road, Pune - 411 001 Tel .: (020) 6127301 Website:www/icmr.nic.in/niv.htm North Maharashtra University PO No. 80, NH No.6, ITI Hostel, Jalgaon - 425 002 Tel.: 252187-90 Website: www.nmu.ac.in Pune University Pune - 411 007 Tel.: (020) 25692039/25690195 Course: MSc Bioinformatics, MBA Biotechnology Website: www.unipune.ernet.in Serum Institute of India 212/2, Hadapsar, Off Soli Poonawalla Road, Pune - 411 028 Website: www.seruminstitute.com Tata Institute of Fundamental Research Homi Bhabha Road, Mumbai - 400 005 Tel.: (022) 22804545 Website: http://www.tifr.res.in/ University of Mumbai Department of Biotechnology, Vidyanagari, Santacruz (E), Mumbai - 400 098 Tel.: (022) 26526053/26528822 Vasantdada Sugar Institute Manjari (Bk) Tal Haveli, Pune - 412 307 Tel.: (020) 26993994 Orissa Central Institute of Fresh Water Aquaculture Kausalyaganga, Bhubaneswar - 751 002 Rajasthan Banasthali Vidyapith PO Banasathali Vidyapith - 304 022 Tel.: (01438) 28341/28348 Website: www.banasthali.org Birla Institute Of Technology And Science Vidya Vihar, Pilani - 333 031 Tel.: (0159) 7642090/7642497 Website: www.bits-pilani.ac.in Tamil Nadu Anna University Sardar Patel Road, Guindy, Chennai - 600 025 Tel.: (044) 22352385/2351126 Website: www.annauniv.edu Avinashilingum Institute for Home Science Coimbatore - 641 043 Tel: (0422) 2438381 Website:www.avinashilingam.edu/ BCG Vaccine Laboratory Guindy, Chennai Tel.: (044) 2342976/2341745 Website: http://mohfw.nic.in/dghs.htm Bharathiar University Maruthamalai Road, Coimbatore - 641 046 Tel.: (0422) 2422222/2422223 Course: MSc Bioinformatics Website: www.b-u.ac.in Bharathidasan University Palkalaiperur, Tiruchirappalli - 620 024 Tel.: (0431) 660392/660271-2 Website: ww.bharathidasan.org Cancer Institute Canal Bank Road, Adyar, Chennai Website: http://www.webhealthcentre.com Centre for Plant Molecular Biology Tamil Nadu Agricultural University, Coimbatore - 641 003 Tel.: (0422) 431222/431821 Website: www.tnau.ac.in Centre for Protein Engineering and Biomedical Research Chennai Voluntary Health Services, Adyar, Chennai - 600 013 Centre for Research in Medical Entomology PO No.11, 4 Sarojini street, Chinna Chokkikulam, Madurai - 625 002 Tel.: (0452) 2650281/2530746 Website: http://icmr.nic.in/pinstitute/crme.htm Entomology Research Institute Loyola College, Chennai - 600 034 Indian Institute of Technology IIT PO, Chennai - 600 036 Tel.: (040) 22351365 Website: www.iitm.ac.in Institute of Brakishwater Aquaculture 141 Marshalls Road, Egmore, Chennai - 600 008 Tel.: (044) 28218216/28218125/28218178 Website:www.dare.nic.in/ciba.htm Madurai Kamaraj University Department of genetic engineering, School of Biotechnology Palkalai Nagar, Madurai - 625 021 Tel.: (0452) 858471-75 Website: www.mkuniversity.org MS Swaminathan Research Foundation 3rd Cross Road, Taramani Institutional Area, CPT Campus, Chennai - 600 113 Website: www.mssrf.org Sathyabama Institute of Science and Technology Old Mamallapuram Road, Jeppiaar Nagar, Chennai - 600 119 Shri AMM Murugappa Chettiar Research Centre Photosynthesis and energy division, Taramani, Chennai - 600113 Website:www.murugappa.com/ SPIC Science Foundation Dept of Biotechnology, 110 Mount Road, Chennai - 600 032 Tel.: (044) 22355662 Website:www.spicscience.org/ Tamil Nadu Veterinary and Animal Sciences University Madhavaram Milk Colony, Chennai - 600 051 Tel.: (044) 25551586/25551587 Website: www.tanuvas.com Tuberculosis Research Centre Mayor VR Ramanathan Road Chetput, Chennai - 600 031 Tel: (044) 28362432/28362433 Website: http://icmr.nic.in University of Madras Centenary Building Chepauk, Triplicane PO, Chennai - 600 005 Tel.: (044) 25368778 Vector Control Research Centre Medical complex, Indira Nagar, Pondicherry - 605 006 Tel.: (0413) 2272396 Website: http://icmr.nic.in Vellore Institute of Technology Ranipet - Katpadi Road, Vellore - 632 014 Tel.: (0416) 243091/245070 Website: www.vit.ac.in   ]]> <![CDATA[ADDITIONAL LIST OF COLLEGES]]> https://biospectrumindia.com/news/95/1979/additional-list-of-colleges.html https://biospectrumindia.com/news/95/1979/additional-list-of-colleges.html Wed, 19 Jan 2005 12:37:00 +0530 New Delhi Netaji Subhash Institute of Technology Azad Hind Fauj Marg, Sector 3, Dwarka, New Delhi - 110 045 Maharashtra Mahatma Gandhi Mission's College of Engg Junction NH 4, Sion-Panvel Express Highway, Kamothe, Navi Mumbai. Shri Vile Parle Kelvani Mandal's College of Engg Plot No. U-15, JVPD Scheme, Bhaktivedanta Swami Marg, Vile Parle (W), Mumbai - 400 056. Thadomal Shahni Engg. College 32nd Road, TPS - III, Bandra, Mumbai - 50. Orissa Majhighariani Institute of Tech & Science (MITS) Bhujabal, Kolnara-765001, Rayagada Dist, Orissa - 765001 West Bengal Bengal College of Engg & Tech Bidhannagar, Sector 28, West Bengal - 713 212 Bengal Institute of Technology Bamanghata, on Basanti Highway, Kolkata Haldia Institute of Technology PO Hatiberia, Haldia - 721657 Heritage Institute of Technology Chowbaga Road Anandpur P.O, East Kolkata Township, Kolkata - 700107 Institute of Technology & Marine Engg Vill-Jingha, PO Amira PS Diamond Harbour, 24 Parganas. JIS College of Engg Block - A Phase, West Bengal - 741 235. Netaji Subhash Engg College Techno City, PO Panchpotha, Garia - 743516. Siliguri Institute of Technology PO Sukhna, Siliguri, Darjeeling Dist - 734225 Uttar Pradesh Allahabad Agricultural Institute Allahabad Agriculture Deemed University, Allahabad - 211 007 College of Engineering & Technology IILM Academy for Higher Learning Plot Nos. 17 & 18, Knowledge Park, Phase II, Greater Noida,Gautam Budh Nagar Dist. College of Engineering Technology Lodhipur Rajpur Delhi Road, Moradabad. Harcourt Butler Technological Institute Kanpur - 208 002. IMS Engineering College National Highway- 24, Delhi-Hapur By-pass Road, Adhyatmik Nagar, Ghaziabad- 201 009. Institute of Engineering & Technology Bundelkhand University, Jhansi-284 001. Meerut Institute of Engineering & Technology Baghpat Road Bypass Crossing, PO Malyana, Meerut - 250 002 Motilal Nehru National Institute of Technology Teliarganj, Allahabad - 211 004. S D College of Engineering & Technology Sahawali, Jansath Road, Muzaffarnagar, Muzaffarnagar - 251 001. Saroj Institute of Technology Ahmamau, Lucknow-Sultanpur Road, Lucknow. Uttaranchal Kumaon Engineering College Dwarahat, Almora Dist - 263 653. Andhra Pradesh Al-Ameer College of Engg & IT Gudilova, Anandapura, Visakhapatnam. Alfa College Of Engg & Tech Allagadda, Kurnool Dist. Anil Neerukonda Institute of Tech & Sciences Sanghivalasa, Bheemunipatnam, Visakhapatnam. Audhishankara College Of Engg & Tech Vindur Panchaya & village, Gudur Mandal, Nellore Dist - 524 101 Bapatla Engineering College Bapatala, Guntur Dist - 522 101 CMR College Of Engg & Tech Survey No. 66,67,82,91,92 & 115/D, Kandla Koya, Medchal Mandal, Hyderabad- 501 401. College Of Engineering - Gandhi Institute of Technology & Management Gandhi Nagar, Rushikonda, Visakhapatnam - 530 045. Devineni Venkata Ramana & Dr Hima Sekhar Mic College Of Technology Kachikacherla, Krishna Dist.-521 180 Godavri Institute Of Engineering & Technology NH 5, Chaitanya Nagar, Velugu Bandha (Village), Rajanagaram (M), Chaitanya Nagar, Rajahmundry - 533 294 Gokaraju Ranga Raju Institute Of Engineering & Technology Bachipally Village, Miyapur, Ranga Reddy Dist -500 050. JB Institute Of Engineering & Technology Survey No. 220, Yenkapally Village, Moinabad Mandal, Hyderabad - 500 075 Joginpally BR Engineering College No.220, Moinbad Mandal, Ranga Reddy Dist.- 500 034 KL College Of Engineering Green Fields Kunchanapalli PO, Via Tadapalli, Guntur Dist- 522 501 Madanpalli Institute Of Technology & Science Rishi Valley Cross, Kadiri Road, Kurabalakota Mandal, Madanpalli Taluk - 517 325. Malla Reddy Engg College Survey No. 593, 594, Gundla Pochampally, Medichal Mandal, Hyderabad - 501 401 Narayana Engineering College Narayana Avenue, Opp. Apollo Hospital, NC Factory, Ak Nagar, Nellore 524 004 Padmasri Dr BV Raju Institute of Technology Vishnupur, Narsapur, Medak Dist - 502 313 Sree Nidhi Institute of Science & Technology Chintareddy Colony, Tarbind, Old Airport Road, Nacharam, Hyderabad - 500 009, Sree Vidya Niketan College of Engineering Sree Sainath Nagar, A.Rangampet, Chendragiri Mandal, Chitttoor Dist - 517 102 Sri Indu College Of Engineering & Technology Sheriguda (Village), Ibrahimpatnam Mandal, Ranga Reddy Dist. St. Martin's Engg. College Survey No. 98,100, Dulapally, Medchal Mandal, R R Dist.-500 014. TKR College of Engg. & Tech Survey No.8, Medbowli Mirepet, Hyderabad- 500 035 University College Of Engineering Osmania University, Hyderabad - 500 007. Vaagdevi College Of Engineering Bollikunta(P), Near Mamoonoor Camp, C-37,M-24, Warangal - 506 005. Tamil Nadu Avinashlingam Institute For Home Science And Higher Education For Women (Deemed University) Coimbatore - 641 043 Bannariamman Institute of Technology Alathukombai Village, Sathyamangalam - 638 401 National Institute of Technology Tiruchirapalli - 620 015 Pavehdar Bharathidasan College of Engg & Tech Mathur Village (PO), Kullthur Taluk, Pudukkottai Dist - 620 024 Rajiv Gandhi College of Engineering Survey No.103, Nimely Village, Sriperambadur Taluk, Kanchipuram Dist. Sree Sastha Institute of Engineering and Technology Chembarambakkam village, Poonamalla Taluk, Trivellore Dist - 602 107. Udaya School of Engineering Udaya Nagar,Vellamadi Junction, Kanyakumari Dist- 629 204 Haryana Ambala College of Engg And Applied Research Akbar Pur, P.O.Bihta, Dist. Ambala, Ambala - 133101. Career Institute of Technology & Management Sector 43, Badkhal-Surajkund Road, Faridabad. Guru Jambeswhar University Institute of Engg & Technology Hissar, Haryana NC College Of Engineering Israna Dist, Panipat - 132 103 PD Memorial College of Engineering Sarai Aurangabad, Bahadurgarh, Jhajjar Dist, Haryana. Punjab Dr B R Ambedkar National Institute of Technology GT Road By-Pass PO, Nussi, Jalandhar - 144 027. Shaheed Udham Singh College of Engg. & Tech Tangor (Mohali), Punjab. Thapar Institute Of Engineering & Technology Patiala. Rajasthan Jaipur Engineering College & Research Centre Opp. Epip Tank Road, Jaipur. Maharishi Arvind Institute of Engg & Technology Sector7, Madhyam Marg, Mansarovar, Jaipur - 302 012 Seedling Academy of Design Technology & Management Main Campus, Khore Bariyan, Jagatpura, Jaipur-302017 Sobhasaria Engineering College Gram-Gokulpura, Sikar Dist. Chattisgarh Govt. Engg. College Raipur, Chhattisgarh - 492 010 Gujarat CU Shah College of Engg & Technology Lakhu Pole, Wadhwan City, Surendranagar-363 030 UV Patel Engg College Ganpat Vidyanagar, Kherva Taluk, Mehsana - 384 001 Madhya Pradesh Madhav Institute of Technology & Science Gola Ka Mandir, PO Residency, Gwalior - 474 005. Samrat Ashok Tech. Institution Vidisha, MP - 464 001 Shri GS Institute of Technology & Science 23 Park Road, Indore - 453003 Shri Rawatpura Sarkar Institute of Technology Peeli Kothi, Bhawani Vilas Thandi Sadak, Datia - 475 661. Sri Satya Sai Institute of Science & Technology Pachama Taluk, Sehore Dist - 466002 ]]> <![CDATA[INDUSTRY VIEWS]]> https://biospectrumindia.com/news/95/1635/industry-views.html https://biospectrumindia.com/news/95/1635/industry-views.html Wed, 19 Jan 2005 12:26:00 +0530 Proper syllabi, the need of the hour Biotechnology is the buzzword today. It is perceived as a hot career choice and more than a job. It is an invitation to participate in the development of new products and processes that could improve the quality of human life as much as any other discovery since the Industrial Revolution. And the Department of Biotechnology (DBT) too believes in the need for highly qualified and skilled workforce in this sector. It has invested heavily in enhancing the availability of well-trained human resource in this sector. There are now over 300 educational and research centers offering formal training in biotech techniques. Despite these efforts, a section of people in the industry that BioSpectrum spoke to said the basic problem was related to the outdated curricula used in most educational institutions. There is considerable time lag in updating of the curricula to include the latest biotechnology breakthroughs. "Students get attracted whether or not they are really interested in biotech and register for the course. Career counseling should begin at the school level itself to ensure that students make the proper decision." - Nirupa Bareja of Biocon "Biotech being a sunrise sector, there is tremendous hype from a career perspective. What we fail to realize is that while the universities are churning out thousands of Biotech students, the quality is still in question. Almost every other college is offering a course in biotech without even having the proper infrastructure and more importantly qualified faculty to train the students. Students get attracted whether or not they are really interested in biotech and register for the course. Career counseling should begin at the school level itself to ensure that students make the proper decision," informed Nirupa Bareja, group head-HR, Biocon. The curricula are also set many times without taking into account the needs of the industry. "Whilst students spend a lot of time and energy studying and thereafter clearing the exams, they may still not have the right knowledge. Again our method of teaching by rout and not with an objective of gaining knowledge is impairing quality students graduating," she added. Professionals, in particular scientists, from the industry should be involved with academicians in looking at the syllabi suggest several other top management heads in the industry. "Biotech courses offered by academic institutions should have more industrial orientation. This can be exemplified by taking a very simple example. How to detect a contamination at various stages of fermentation? This type of practical may carry five marks in the syllabus of Microbiology or Biotech courses. However, in the biotech industry, if you are unable to detect the contamination proactively, then you may have to drain the whole fermenter batch leading to a loss of Rs 5- 15 lakh depending upon the price of biotech product. Hence, the mindset of biotech students should be oriented for the functioning of biotech industrial set up right from undergraduate students," opined Bipin Deshmane, general manager, Fermentation, Shreya Biotech Pvt Ltd, Mumbai, who is also a member of Board of Studies of Microbiology and Environmental Sciences of Shivaji University, Kolhapur. Biotech syllabus of many universities at graduate and post-graduate level does not adequately cover the following areas. Regulatory requirements of biotech industry in general and biotherapeutics and biologics industry in particular. Quality Control analysis-in process as well as finished product analysis-of biotech products in general or r-DNA products in particular. â€¢ Current Good Manufacturing Practices (cGMP) and Current Good Automated Manufacturing Practices in Biotech industry (cGAMP). Knowledge of various international regulatory agencies like the US FDA, UK MCA and Australia TGA etc. for getting accreditation for manufacturing facility. Knowledge of various regulatory approvals required for setting up a biotech factory e.g. factory inspectorate, pollution control board, FDA and GEAC. Although upstream i.e., fermentation part for biotech product is covered in detail, the downstream i.e., the purification and recovery part of biotech products is not adequately covered. Financial, commercial and business aspects of biotech industry. "Being a member of the Board of studies in Microbiology, Shivaji University, Kolhapur, I had the privilege to introduce some of these topics in their graduate and postgraduate syllabi. PG diploma courses covering these areas can be introduced in the academic biotech institutes, for example PG Diploma in Regulatory Affairs and PG Diploma in Quality Control in Biotech. Biotech is a multidisciplinary field. Hence, various departments of college or universities like Chemistry, Botany, Zoology, Microbiology, Biochemistry, Chemical Engineering, and IT can come together and contribute for the development and execution of excellent biotech courses," Bipin Deshmane suggested. "Globalization of education is around the corner and biotechnology will not be exception to that. Our biotech institutions have to gear up to meet the challenges posed by globalization. Biotech academic research institutes should take up research projects relevant and useful to biotech industry and should achieve the paradigm shift in the approach from 'Publish or Perish' to 'Patent and Flourish'!" he added. "A biotechnology course should be run in its own department. Alternatively the colleges should organize Departments of Bioscience, so that the infrastructure and staff can be meaningfully used for all the biology courses." - Dr Kameswar Rao of FBAE According to Dr SD Ravetkar, senior director, Serum Institute of India, biotech institutes should have some accreditation system and this should be decided by a joint committee of academicians, people from the industry and DBT. "They should impart theoretical knowledge along with hands-on practical experience. Courses should be designed with industry feedback to create product i.e., 'student' required by customer i.e., industry. This will also help students to get jobs immediately and to their satisfaction. Lately, more demand and less supply has resulted in a good rate of absorption of students," he observed. Talking about the rate of absorption of these students, Nirupa Bareja said, "The supply is far ahead of the demand and we receive a huge number of applications all through the year. Last year we received over 60,000 applications. As mentioned earlier the quality of a major chunk of these applications is average to below average, hence we do a very selective hunt for top quality people even at entry levels. Also, Biocon being a leader in the Biotechnology arena is most preferred and hence the huge number of applications." "Basically the curriculum has to be designed in such a way that it should meet the needs of the industry. There are different levels involved in biotechnology and bioinformatics. Even we find there is a lack of trained teachers who can share their experiences on different aspects in bioinformatics. There should be a good interaction between the academic and research institutes, where researchers are working on many projects. This helps the students to know the practical aspects," felt Rajeev Gangal, founder, SciNova Technologies, Pune. The academic institutions should maintain and upgrade the mode of selection at the time of admission. Otherwise it will be difficult to teach/ train the students with various aspects of biology, mathematics, statistics and other fields of sciences is another suggestion. "The universities should also look for tie-ups with the leading/top education institutions in the world like MIT to get the feel of the actual research. Instead of short-term projects (2-3 months - summer-winter projects) the institutions should look for associations with industry so that the students can take up projects for six months to two years. They should also look for affiliations with the companies such as Ocimum Biosolutions and GSK Biosciences," Gangal added. "Students passing out from our institutions and universities lack practical training as most of the institutions don't have proper infrastructure. We need to have more training centres like IITs," said Varaprasad Reddy, managing director, Shantha Biotech, Hyderabad. Dr Dhananjay B Patankar, head-Biotechnology, Intas Pharmaceuticals Ltd, said, "As a company we look for good students with basic and fundamentals not with just bits of this and that. The students should have a thorough knowledge of the subject. The title of the degree doesn't matter for us. We look for quality and content. The universities, which are offering biotechnology courses, are heavily depending on molecular biology and genetic engineering. In addition to that we also look at students who have completed courses on enzymes, microbiology, biochemistry etc." "The candidates during the interview say that they are interested only in doing research. But there are many opportunities in other fields like quality control, production/manufacturing that are equally challenging like doing research. Hence I feel the universities should highlight these areas to the students so as to take up a career in these fields." "The mindset of biotech students should be oriented for the functioning of biotech industrial set-up right from undergraduate students." - Bipin Deshmane jof Shreya Biotech With the product patent regime in the pipeline, universities should look at offering extra courses on patents as a one of the subjects during the three-four year course by inviting guest lecturers, industry people and law firms to teach the basics on patents and other regulatory issues some others have avered. The universities instead of opening new departments should strengthen the existing departments in terms of infrastructure, increasing the number of visiting faculties etc. Many leading biotech firms have started tying up with leading institutions to train people in this field. Ocimum Biosolutions, one such company dealing with bioinformatics solutions, offers a six-month training programme in partnership with the Michigan Technological University. "This is a rather rigorous course and only about 10-15 students are selected for training. We absorb about 40 per cent of them in-house," said Anuradha Acharya, CEO, Ocimum Biosolutions. "We have placed almost all our students in India and abroad," she added. "It is very much important to get the right kind of training if one wants to really succeed in this field," she felt. Though biotech is a buzzword, several industry leaders speak about the shrinking base of students interested in science education. Talented students opt for studying medicine or engineering. Added Akilesh Pandey, chief scientific adviser, Institute of Bioinformatics, Bangalore, "We encountered major problems in the recruitment of research trainees. The quality of postgraduates in biotechnology, biochemistry and biology varies drastically. Even when the applicants were somewhat good, they often showed a clear bias towards the thinking prevalent in their institutes where they underwent their training." The DBT has pointed out there has been an unrealistic projection of the manpower requirement in the sector due to which a number of private engineering colleges have started offering biotech courses even at the B Tech level. It also pointed out that many universities were offering bio-informatics courses at the undergraduate level, without adequate infrastructure and faculty support. Therefore, the quality of these students had become a big question mark. The DBT has highlighted the need to set up a regulatory body under the AICTE for the maintenance of the standard of education. The Department felt that there was a need to focus on post-graduate and research programs on biotechnology, and B Tech programs should be restricted only to those institutions which have established departments of chemical engineering. The Department has also recommended not to sanction undergraduate programmes on bio-informatics, and to restrict such programmes only at the post-graduate level. Dr C Kameswara Rao, executive secretary, Foundation for Biotechnology Awareness and Education (FBAE), expressed, "As biotechnology is not a single subject in itself and as it is of a recent origin, necessarily teaching has to be done by those who have degrees in botany, zoology, microbiology, biochemistry, etc. However, the teachers who teach biotechnology must have some exposure to the theoretical aspects and hands-on-experience in the practical aspects, of the subjects they teach. Hence, colleges that recruit people qualified in basic subjects to teach biotechnology, should encourage and support the teachers", he suggested. Talking about refresher courses and laboratory training programmes for biotechnology teachers, Dr Kameswara Rao said that the UGC supported teacher training under the refresher course program in all subjects. But there were no refresher courses for the biotechnology teachers, who he felt, need them more than the teachers of other subjects. It is an unarguable need that such training programmes are organised to enhance teacher competence, he noted. Dr Kameswara Rao noted that it was important that all universities prepare statutory documents for all the courses of study that will help both the colleges as well as the Local Inquiry Committees (LICs). This will bring some uniformity in the facilities provided by the colleges, he said. "A biotechnology course should be run in its own department. Alternatively the colleges should organize Departments of Bioscience, so that the infrastructure and staff can be meaningfully used for all the biology courses", he pointed out. In the engineering colleges it appears that the departments of chemical technology, wherever present, seem to stake claim to run the BE course in biotechnology, which is not in the interests of the course, in the long run, he added. Stressing on the need for an academic audit, Dr Kameswara Rao said it was urgently needed in order to identify the colleges that are upto an acceptable standard and to caution those that are substandard, so that they rectify the shortcomings. If they did not comply in a reasonable time, they needed to be disaffiliated. It would be in the interest of the colleges to go through the audit process, as they would give an opportunity to officially establish their credibility, he suggested. Dr S Shantharam, International Food Policy Research Institute, Washington, felt that there is no need for new biotech institutions, while the existing institutions are in great need of financial inputs to perform even minimally. He stressed the need for sufficient governmental funding to make the curricula, faculty and laboratory facilities to offer internationally competitive educational programs. He emphasized the need to educate the public and the media and considered that an informed student community will function as the best ambassadors of biotechnology and would help in removing the misconceptions and baseless fears regarding the perils of biotechnology from the public mind. With no proper syllabi on biotechnology, the industry is facing a lot of hurdles. Namratha Jagtap with Rolly Dureha and Narayan Kulkarni ]]> <![CDATA[Johnson & Johnson to acquire Guidant]]> https://biospectrumindia.com/news/95/1400/johnson-johnson-to-acquire-guidant.html https://biospectrumindia.com/news/95/1400/johnson-johnson-to-acquire-guidant.html Thu, 06 Jan 2005 16:58:00 +0530 Under the terms of the agreement, each share of Guidant common stock will be exchanged for $30.40 in cash and $45.60 in Johnson & Johnson common stock, provided the average Johnson & Johnson common stock price is between $55.45 and $67.09 during the 15-day trading period ending three days prior to the transaction closing. Each Guidant share exchanged would be converted into Johnson & Johnson common stock of not more than .8224 and not less than .6797 shares, plus $30.40 in cash. The transaction has an estimated net acquisition cost of $23.9 billion, as of the close of business on December 15, 2004, based upon Guidant's approximately 334 million fully diluted shares outstanding, net of estimated cash on hand at the time of closing. The boards of directors of Johnson & Johnson and Guidant have given their respective approvals to the transaction, which is subject to clearance under the Hart-Scott-Rodino Antitrust Improvements Act, the European Union merger control regulation, and other customary closing conditions. The agreement will require the approval of Guidant's shareholders. Guidant and Cordis Corporation, a Johnson & Johnson company, will become part of a newly created cardiovascular device unit within Johnson & Johnson. The newly created franchise will be named Guidant while the Cordis name will be retained for select businesses within the franchise. This business unit will report to Nicholas J Valeriani, a member of the Johnson & Johnson Executive Committee. "The combination of these businesses will enable us to bring innovative new therapies to patients and their physicians in this very important and fast growing therapeutic area," said William C Weldon, chairman and chief executive officer, Johnson & Johnson. Tripos to acquire Optive Research Tripos Inc., a molecular discovery software company, entered into a definitive agreement to acquire privately held Optive Research Inc. Under the terms of the agreement, Tripos will issue 599,521 shares of its common stock (a portion of which will be contractually restricted) and $4.75 million in cash to Optive's shareholders. The cash portion will be funded by a group of new investors through the issuance of $3.5 million of subordinated debt, 111,606 shares of common stock, and warrants to purchase 156,250 shares of common stock. The acquisition is subject to certain closing conditions and is expected to close in January 2005. "We are actively seeking opportunities in all areas of our business to drive the next level of the company's growth," said Dr John P McAlister, president and chief executive officer, Tripos. "The acquisition of Optive adds important new products, key enabling technologies and world-renowned scientific expertise to our software business, allowing Tripos to offer an even broader array of innovative informatics solutions to its customers." Alltracel acquiresWestone Alltracel Pharmaceuticals PLC, a bio-pharmaceutical R&D company specializing in the medical device and food ingredient markets, announced to conditionally acquire the entire issued share capital of Westone Products Ltd. Westone is a London-based privately-owned product development company which has a number of patents in oral care and PTFE processes as well as access to manufacturing and packaging facilities in Shenzhen, China via a 50 percent joint venture. Westone revenues for the year ended September 30, 2004 was in excess of Euro10.5 million. The acquisition is for an initial consideration of approximately Euro 5.8 million, of which approximately Euro 3.8 million will be in cash with the balance by the issue of Alltracel ordinary shares on completion. Commenting on the proposed acquisition, Alltracel CEO Tony Richardson said, "We believe that the combination of Alltracel and Westone will give a solid platform for expanding the m.doc brand and an enhanced capability to bring new products to market in the woundcare, oral care and cholesterol management markets." Genzyme completes acquisition of ILEX Oncology Genzyme Corp. has completed its acquisition of ILEX Oncology Inc., a cancer drug development company. The stock-for-stock transaction is valued at approximately $1 billion. While ILEX already has a product in the market, a second product is nearing approval and a third one is into Phase 2 development. "Genzyme has conducted important research in oncology for several years," said Duke Collier, executive vice president, Genzyme. "It is a challenging disease, but one where biotechnology can make a significant difference to patients and their families. With our acquisition of the cancer diagnostics business of Impath Inc. earlier this year, and now with this exciting acquisition of the therapeutics products and development experience of ILEX, Genzyme is taking major steps to build its presence in oncology." Nanogen and Epoch merge Nanogen Inc., which develops advanced diagnostic products, has announced stockholders approval of Epoch Biosciences merger. Under the terms of the merger agreement, Epoch stockholders will receive 0.4673 shares of Nanogen common stock in exchange for each share of Epoch common stock they hold. At the completion of the merger, Nanogen will have approximately 50 million common shares outstanding. The value of the transaction was approximately $97 million. Nanogen's diagnostics are used to predict, diagnose and treat diseases. Its products include NanoChip molecular biology workstation, NanoChip electronic microarrays and analyte specific reagents to develop tests to detect mutations associated with genetic diseases. A next generation instrument system, NanoChip 400, is expected to be available in 2005. On the other hand, Epoch Biosciences develops and sells proprietary products with commercial applications in the genomics and molecular diagnostics fields. Bionomics to acquire Neurofit Bionomics Ltd has agreed to acquire Neurofit. The acquisition is expected in early 2005. The acquisition is anticipated to enhance Bionomics' therapeutic development capabilities for CNS disorders. Neurofit's core business is preclinical testing of developmental therapeutics for CNS disorders using cellular and animal models. Its client base includes international pharmaceutical and biotechnology leaders Novartis, Serono, Boehringer-Ingelheim, Guilford Pharmaceuticals and Biogen. Neurofit has annual sales of approximately Euro 1 million and is expected to operate profitably within the Bionomics group. In addition to the CRO business, the acquisition includes intellectual property rights to an animal model of Parkinson's Disease, developed by Institute Pasteur. The transaction is valued at Euro 1.25 million. Sanofi-Aventis merger completed Sanofi-Aventis announced that the extraordinary general meeting of its shareholders approved all resolutions relating to the proposed merger of Aventis with and into Sanofi-Aventis, including the exchange ratio of 27 Sanofi-Aventis shares for 23 Aventis shares. The merger came to effect on December 31, 2004. ]]> <![CDATA[Funds Are Not a Constraint]]> https://biospectrumindia.com/news/95/2414/funds-are-not-a-constraint.html https://biospectrumindia.com/news/95/2414/funds-are-not-a-constraint.html Thu, 06 Jan 2005 16:56:00 +0530 Funds Are Not a Constraint Biotech entrepreneurs are looking for funds. Similarly Venture Capitalists (VCs) are also looking at newer areas of investment opportunity to reap maximum returns. Biotechnology is one of many newer areas VCs are eyeing. "Companies with a Level of Predictability on Cash Flow Havex Been Preferred." Prasanna Desai, director, corporate finance, KPMG India Pvt Ltd What is your perception on this sector? Although biotechnology includes other sectors, most investors have focused on biopharmaceuticals. Investors have preferred companies with a level of predictability on cash flow. Hence, it is critical for pure research companies to have a well-defined business model to monetize the research. Understanding the industry is a key factor for the investors as the companies look at different levels of funding. The most important factor which is pulling the investors towards biopharmaceuticals is the opportunity and scope to invest in a growing industry. India known for its research and talent pool is another factor that is supporting the investors to look at Indian biotechnology companies. Greater level of awareness about the latest developments in the biotechnology front, education, believing in sharing risk and reward, a well defined exit model, result oriented research which should deliver and building the business for the company will help the investors to fund the companies in biotechnology. What are the five key considerations? Business model, background of the promoters, strong management, the exit model for the investors, and structure of the investment that includes risk sharing by both investors and the promoters A small start-up company, in the field of nanotechnology promoted by a technocrat, started looking for funds after working on the pilot scale-up facility to increase the production capacity. It approached many financial institutions through its financial advisors and held discussions with banks, financial institutions, and venture capitalists for a few crores. Venture capitalists expressed desire to fund a minimum of Rs 10-20 crore but the promoters were not so eager on such an amount and did not want to take so much of a risk. On the other hand, the promoters were approached by a socio-cultural organization based in Bangalore to support the company by funding to tune of over Rs 10 crore. India's first biotech fund initiated by a public-private partnership, APIDC-VCL raised Rs 150 crore, five times more than the Rs 30 crore envisaged from different financial institutions in a span of just a little over a year. Even local venture capitalists have raised Rs 3,000 crore from local financial institutions like insurance companies, commercial banks, mutual funds and government bodies. The allocations from these institutions have increased from Rs 10-20 crore to Rs 50-100 crore this year. According to the Indian Venture Capital Association (IVCA), domestic and foreign venture capitalists invested $774 million in 2003 in India up from $590 million in 2002. In 2004, till November, VCs and equity funds invested over $820 million in Indian companies. TSJ Media, a Chennai-based firm that tracks VC investments, reported that less than 10 percent of this money has found its way in the start-up companies. The momentum has just started to pick up after 2000-01 and Indian VCs have undergone a fundamental change. This clearly shows that there are investors who are really looking at investing in upcoming technology companies like nanotechnology and biotechnology. So money is not a constraint as far as investors are concerned. Then what is it that is stopping them from making investments? Is there a disconnect between the industry and the VCs? Both have valid reasons and apprehensions. The Association of Biotechnology Led Entrepreneurs (ABLE) arranged a meet between investment bankers, research analysts and CEOs of biotech companies on December 5, 2004 on Mumbai. The meet, sponsored by Biocon, deliberated on the key facts and parameters of investing in biotechnology driven enterprises and to exchange views. The investors point of view was that it is the risk factor, lack of readily available information on biotechnology, strong management, clear exit model, lack of technical skilled people and experts who can guide VCs as some of the factors making them very cautious. However, they are convinced that India will be the next technology center and research hub owing to intellectual capital, skilled manpower and value addition and that it has sustainable comparative advantage over China. VCs are looking at tie-ups between Indian and Chinese companies where the Indian product design team can have close relationships with manufacturing teams in China. India and China as a combined market opportunity can weigh much more than they do separately. This model will provide an edge for VCs to invest in India and China against US. Such model is already in place in the field of IT, where the VCs marry two sets of people in the US and India to form a team. The US team brings in the product management and customer interfacing skills and the Indian team brings product design and execution skills. Utkarsh Palnitkar, head, life sciences, Ernst &Young, who is closely tracking the industry, noted that biotechnology would enter profitability by 2008. VCs are looking at biotechnology with caution in spite of several opportunities in biotechnology i.e., biopesticides, biofertilizers and diagnostics. Indian companies have a lot of opportunities, if risks are broken down into smaller parts. Bundle of ideas are lying in cold storage. To make it a reality and take up risks, sharing of risks is very important. Proper blueprints should be developed for implementing ideas into projects that ultimately deliver results. Undoubtedly everyone recognizes that biotechnology is an evolving and emerging industry. About 60 percent of the drugs the world over are monoclonal antibodies (MAbs). The process of developing the present available MAbs was started way back in the 1970s. Kiran Mazumdar Shaw, chairman and managing director, Biocon India observed, "The success for Biocon India didn't follow in a day. It took years for us to reach this stage. We did projected insulin in our business plan sometime back in 1999 but it was realized in 2004. High risk will pay back high returns. We showed that product is predictable. Still investors look for predictable products from biotechnology companies." Why are investors still cautious? "Investors look at biotechnology as a pharma industry. They look at predictable products of pharma companies. Considering the excitement in biotechnology space, India can leverage on its advantages by co-development, by entering into tie-ups with global companies, focusing on quality and innovation. Although drug development is very expensive, India can play a key role in this sector. Therapeutics and monoclonal antibodies are the products of the future and are emanating from biotechnology. India is known for developing diagnostic kits at lower cost. Opportunities are there in diagnostics sector too," she asserted. Dr BV Ravikumar, managing director of XCyton Diagnostics, who is looking for funds for expansion noted, "Multinationals are investing heavily on developing newer kits. Instead of depending on such kits, why should we not start developing such kits for ourselves and export to other countries. One has to make a beginning. Let us start ahead to lead the path. For this we do need funds." Dr Villoo Morawala Patell, founder and CEO, Avesthagen, has a point. She believes VCs should have technical staff and research analysts who have expertise in life sciences and legal issues to guide decision-making, as biotechnology is a heterogeneous and diverse sector unlike the IT industry. Agrees Alok Gupta, country head, Life sciences and Biotechnology, YES Bank Ltd and observes, "We couldn't afford to recruit technical people with PhD background. India still lacks technical people with knowledge on legal and licensing issues whereas in the USA there are many people and experts in licensing." He reiterated that there is enough money/funds available for the biotechnology industry. "There Is Need to Deepen Early Stage Financing" - Alok Gupta, country head, life sciences and biotechnology, Yes Bank Ltd. What is your perspective as an investor? From an investor perspective, the opportunities in the Indian biotechnology industry are looking increasingly attractive due to the following reasons: Indian pharmaceutical companies are foraying into biotechnology (starting with generics)-financing is supported by strong parent balance sheets Overseas companies are establishing R&D facilities and contract manufacturing facilities and network in India. They have strong parent balance sheets, but need advisory handholding (regulatory, operational and management) for expediting India plans. First generation entrepreneurs are establishing a base in India and are setting up contract services operations, with a strong linkage with global MNCs ensuring a sustainable market demand in the formative years of the company. Overall, there is an increased focus on India as a business location for manufacturing and contract services. Hence, investment opportunities in the country are looking attractive. Which are the five main hindrances? Explain! Business model: A large number of early stage biotechnology companies in India have little uniqueness and novelty (of product, of business model etc.); consequently, this makes it difficult to justify funding such me-too companies. Early stage investing: Most early stage biotech companies need angel/seed funding in order to attain a critical mass and attract investor interest. This channel of funding needs development in India. Further, early stage companies need to have a clear road map of product development/business plan, with capital infusion, timing and exit routes. Technology: Most interesting biotechnology companies are based on novel technologies, products or platforms that will provide the necessary differentiation to the company. Most funds do not have a deep understanding of the technology or applications of this technology and hence are looking to validate the product/business model through US-based VCs, which have the necessary expertise in evaluating such companies Cash flows and valuations: Most biotech companies (particularly product companies) have fairly long gestation periods before they commence significant cash flow generation-this is an area of concern for investors and consequently valuations and dilution becomes an area of concern Risk factor: Biotechnology companies are typically in a high risk-reward situation whereby success of failure of a product can imply survival or collapse of the company. So investors are selective about biotech investments. Exit strategy: The Indian markets do not offer the depth or flexibility of exit options to investors. For example, the capital markets and strategic investor interest in the US markets leads to a lot of different exit options for financial investors. Another issue that is coming in the way is sharing of intellectual property (IP) with the investors. In Western countries, the companies do propagate the sharing of IP. Swiss biotech companies are successful in bringing funds from the US. But Indian companies are reluctant to share the IP. Indian companies are unable to attract the interest of the US investors. Sonia Dasgupta, vice president, J M Morgan Stanley Pvt Ltd, observed, "Sometimes the entrepreneurs become very exited about their concepts. They are even carried away by the ideas. But they fail to work on the realistic valuation of the project. They are also reluctant to share the failures and risks involved in the taking up the projects. The projects involve long gestation period and it is necessary for entrepreneurs to prepare a proper contingency plan for the project. The companies should be realistic about the product discovery and the market potential. We are answerable to the investors. We do need a lot of information to understand the depth of technology and concept." Considering the opportunities, Prashant Jain, chief investment officer, HDFC Asset Management Company Ltd said, "Biotech companies should look at a derisked model, developing a strong product pipeline to seek funds from the venture capitalists. This can be achieved only by having a strong management that should try to meet the expectations of the foreign funds as the benchmark for foreign funds and local funds differs." Clearly, from what transpired at the meeting, VCs are eager to invest in this sector, but lack of information has made them adopt a wait and watch policy. The entrepreneurs need to look at different models and be ready to share the minimum information necessary for the investors to take the risk. The investors and industry should work together and an industry body like ABLE can play a collaborative platform and mitigate some of the doubts. ABLE's intent to schedule the first ever bio-investors meet in January is a right step in that direction. Narayan Kulkarni   ]]> <![CDATA[India Enters Product Patent Regime]]> https://biospectrumindia.com/news/95/5218/india-enters-product-patent-regime.html https://biospectrumindia.com/news/95/5218/india-enters-product-patent-regime.html Thu, 06 Jan 2005 16:53:00 +0530 Kamal Nath, union minister of commerce and industry, announced in December that there are two significant developments in the world of commerce and industry that would open vast opportunities for India in the New Year. "Both are connected with the world trading order, of which India is a part: one is the final phase-out of the Multi-Fibre Agreement and the other is marked by India's conformity with the international Intellectual Property System in all respects, on terms that are practical and credible," he said. Important public interest provisions in the Patent Law Conditional grant of patent [Section 47]: This empowers the Government to import, make or use any patent for its own purpose. For drugs, it also empowers import for public health distribution. Revocation of patent in public interest [Section 66]: This empowers the Government to revoke a patent where it is found to be mischievous to the State or prejudicial to the public. Grant of compulsory licence [Sections 82 to 94]: Chapter XVI deals with the general principles and circumstances for grant of compulsory licenses in order to protect public interest particularly public health and nutrition. These provisions check the abuse of patent rights. They can be invoked if the reasonable requirements of the public with respect to patented inventions have not been satisfied, and the patented invention is not available for public at a reasonably affordable price, and if the patented invention is not worked in the territory of India. Note: [Section 92]: This provides for action in case of national emergency, extreme urgency and public non-commercial use, and can be invoked without the grace period of 3 years from grant of patent. Use of invention for the purpose of Government [Sections 100 & 101]: This complements section 47. Acquisition of invention and patent for public purpose [Section 102]: This empowers the Government to acquire a patent to meet national requirements. Bolar provision [Section 107 (A) (a)]: This facilitates production and marketing of patented products immediately after expiry of term of patent protection by permitting preparatory action by non-patentees during life of patent. Parallel import [Section 107(A) (b)]: This provides for import so that patented product can become available at the lowest international price. Kamal Nath, union minister of commerce and industry The Ordinance on Patents was the same as the Bill introduced last year but with improvements in some significant respect. Elaborating on this, he said, "We have introduced a provision for patenting of software that is embedded in hardware. We have also provided for a definite pre-grant opposition procedure. The earlier Bill had only a post-grant opposition, with a weak pre-grant representation. After extensive discussions we have decided to have both pre-grant as well as post-grant opposition." The government has rationalized the timelines, so as to not leave everything open-ended, but have a definite time-table within which each of the stages should take place. This would reduce by half the maximum time it takes for the processing of an application, from more than nine years to about four. Another significant modification is the introduction of a provision to protect Indian industry from infringement proceedings with retrospective effect. It has specifically provided that patent rights for mail box applications will only be available prospectively. These changes have been made after wide consultation. Dr Swati Piramal, director, Nicholas Piramal India Ltd The Third Amendment was only the culmination of a process begun 10 years ago. The Bill was introduced in parliament a year ago by the previous government, but it lapsed (owing to the elections). "It was our desire to bring the Bill to parliament first. But it was also necessary to consult with all stakeholders and political parties. Group of Ministers got the feedback from industry associations and experts on December 21, so it was not possible to bring the Bill to this session of parliament. This has necessitated the ordinance. The ordinance will be discussed in detail in parliament in the budget session. The ordinance is an interim measure to fulfil our legal obligations within the stipulated time," Kamal Nath added. The Patents (Third) Amendment ensures that the reasonable requirements of the public with respect to availability and affordability are taken care of and public interest particularly public health and nutrition is protected. The law effectively balances and calibrates Intellectual Property protection with public health concerns and national security. By participating in the international system of intellectual property protection, India has unlocked itself for vast opportunities in both exports as well as its potential to become a global hub in the area of R&D based clinical research outsourcing, particularly in the area of biotechnology. It's a mixed bag VN Balaji, chief scientific officer, Jubilant Biosys Ltd There was a mixed response to the government's ordinance from different quarters of the society. The pharmaceutical industry and political parties expressed concern over the government using the ordinance rouse to effect patent changes. The industry is of the opinion that the Bill would have increased the acceptability provided the government had brought it after the deliberations on it in the parliament. A coalition partner of the UPA government, CPI (M) reacted sharply on the ordinance. It said it had advised the government against the hasty passage of the Bill "as many measures need to be taken to protect the interests of the country. The politburo disapproves of the resort to ordinance to pass such an important legislation. There are whole ranges of issues connected with TRIPS agreement and safeguarding of national interest. The Bill, which has been passed as an ordinance, does not serve the purpose." Similarly the Center of Indian Trade Unions (CITU) also condemned the ordinance. According to some reports it observed that having opened the door for limitless patenting and patenting of products proves that the government has willingly weakened its position before the powerful economies, which control 99 percent of all patents. India is not on the same platforms. It also noted that this will place India at the receiving end and would pay heavily for everything particularly drugs, biotechnological products and pesticides. "Definition of patent-ability is vague" - DG Shah, secretary general, Indian Pharmaceutical Alliance Section 3: What are not inventions. Record of Discussions of the meetings of the Group of Ministers has noted at item 5(c) as under: "Existing law does not provide for 'evergreening' of patents, as it prohibits patents on mere new use for a known substance, substance obtained by mere admixture, etc." However, this leaves definition of patent-ability vague. It does not clarify that patents intended to delay entry of generics, such as patents for polymorphs, hydrates, isomers, metabolites, substantially pure, particle size, blood levels, etc., will not be patented. It would lead to litigations. The Government seemed to have abdicated its responsibility to jurisprudence. Section 11A: Publication of applications. Option for early publication of the application and conferring like privileges and rights as if a patent for the invention has been granted on the date of publication of the application has potential for abusive practices wherein the applicant for a weak patent may delay examination of patent, thereby placing generic producer at a disadvantage. This is not a TRIPS requirement. Section 25: Opposition to grant of patent. Contrary to the public statements in the Press and Record of Discussions at the meetings of the Group of Ministers, the Ordinance is silent on the hearing and the 'composite order' and mentions only of representation. Section 39: Prohibition to apply, under certain circumstances, for patents relevant for defence purposes, etc. The existing provision was for inventions relevant for defense and atomic energy only. This is now being expanded to cover any application outside India. This will be prejudicial to the interest of domestic pharmaceutical companies filing patents for incremental inventions outside India, given the complexity of the filing, speed and the need for confidentiality. Section 92A: Compulsory licence for export of patented pharmaceutical products in certain exceptional circumstances. The provision requires even LDCs under the extended transition period up to 2016 to grant the Compulsory Licence. This is contrary to the TRIPS Council decision and will expose LDCs to undue pressures. "Definition of patent-ability is vague" Suresh G Kare, president, Indian Drug Manufacturers' Association The pharmaceutical industry observed that the patents ordinance has been issued to fulfil India's commitments and obligations under the TRIPS agreement. But it does not cover all necessary safeguards. Although it provides an opportunity for the government to further bring in changes in the law when enacted, the concern among the industry people is if no consensus arises in parliament what will happen, as the ordinance will lapse (ordinance's life being only six months). However, big pharmaceutical companies like Nicholas Piramal, which believes in its scientists and scientific strength and Jubilant Biosys that were prepared for the product patent regime reacted positively to the ordinance. Dr Swati Piramal, director, Nicholas Piramal India Ltd, said, "I'm happy that the government has done it on time. It's a good job. And we are hopeful and optimistic that the parliament will also ratify it. It is a positive and futurist approach to compete internationally". Sharing his excitement VN Balaji, chief scientific officer, Jubilant Biosys Ltd, said, "This proves beyond doubt the government's intent to be part of the global village and provides a great opportunity for the Indian pharmaceutical and biotechnology industry to reap the fruits of innovation in the global market place. It gives an opportunity for the multinationals to make investments in the country. It helps in enriching the credibility of the Indian companies and also developing the value added products. This will generate more employment opportunities and support R&D activities in the country." Expressing similar views RK Sinha, executive director, All India Crop Biotechnology Association said, "It will give a boost to biotechnological inventions by making such inventions eligible for product patent. This will enable the flow of state-of-the-art technology as well as FDI to the overall benefit and growth of Indian agriculture." The ordinance on product patent has also brought in some cheer among the stocks of the pharma multinationals on December 27, 2004 over the local stocks. The investors felt that the pharma multinationals may launch newer drugs in the local market in the new patent regime. It is not so easy as the ordinance has to get clearance of the parliament in the budget session. The blockbluster drugs are expected to hit the Indian market only after 2007, as viability of the new drugs has to be studied carefully. The pharma multinationals have to continue with their existing product portfolio. However, the pharma industry bodies expressed some concern saying that the ordinance does not cover all the necessary safeguards. They urged the government to include the suggestions in the rules when enacted. Suresh G Kare, president, Indian Drug Manufacturers' Association, (IDMA) said, "The expected Patents' Ordinance has been issued. With this step we have fulfilled our entire set of obligations and commitments under the TRIPS Agreement. The product patent in pharmaceuticals, food and agro-chemicals is now operative. The era of inexpensive medicines due to earlier process patent is becoming history. The new-patented medicines now will be sold at the monopoly price laid down by their patent holder (owner). How expensive they will be compared to price structure so far when many parties were producing them is anybody's guess." He further noted, "We were expecting that the Patents' Ordinance (in lieu of the Third Amendment Bill), which would introduce Product Patent in pharmaceuticals, will take care of all deficiencies in the Patents' Law i.e., the Patents' Act 1970 as well as the two Amendments made in it so far. However, we are disappointed to find that some crucial points have either been left out or have been treated in a half hearted manner. It is necessary to highlight these points, so that when the Patents Third Amendment Bill comes up before the parliament during the Budget session, these deficiencies can be corrected. It may also be mentioned that some claims made by the government such as a three-month period for an appealable pre-grant opposition, insistence on local working etc. do not appear in the ordinance. Hopefully, these will be covered in Rules expected to come out soon." Salient features of Third Amendment to the Patent law Extension of product patent protection to all fields of technology (i.e., drugs, food and chemicals); Deletion of the provisions relating to Exclusive Marketing Rights (EMRs) (which would now become redundant), and introduction of a transitional provision for safeguarding EMRs already granted; Introduction of a provision for enabling grant of compulsory licence for export of medicines to countries which have insufficient or no manufacturing capacity, to meet emergent public health situations (in accordance with the Doha Declaration on TRIPS and Public Health); Modification in the provisions relating to opposition procedures with a view to streamlining the system by having both Pre-grant and Post-grant opposition in the Patent Office; Addition of a new proviso to circumscribe rights in respect of mailbox applications so that patent rights in respect of the mailbox shall be available only from the date of grant of patent, and not retrospectively from the date of publication. Strengthening the provisions relating to national security to guard against patenting abroad of dual use technologies; Clarification of the provisions relating to patenting of software related inventions when they have technical application to industry or are in combination with hardware; Rationalization of provisions relating to time-lines with a view to introducing flexibility and reducing the processing time for patent applications, and simplifying and rationalizing procedures. Though the ordinance has been passed by the government, the industry bodies want the government to reconsider the ordinance and include the suggestions made by them in the final Amendment. The government, which is committed to TRIPS agreement, should implement the ordinance by making necessary changes in the existing one while discussing during the budget session of parliament without much delay. Faster implementation will enhance the confidence of the investors and research activities in the country. Narayan Kulkarni with Rolly Dureha in New Delhi and Srinivas Rao in Bangalore ]]> <![CDATA[BioProducts]]> https://biospectrumindia.com/news/95/1747/bioproducts.html https://biospectrumindia.com/news/95/1747/bioproducts.html Thu, 06 Jan 2005 16:48:00 +0530 Millipore introduces new centrifugal filter Millipore has launched Centricon Plus-70, a centrifugal filter device. The device is optimized for concentrating and desalting proteins, antibodies, and viruses from chromatography fractions, cell culture supernatants, fermentation broths, and biological fluids. It can also be used for exchanging buffers. Centricon Plus-70 can concentrate 70 mL down to 350 Ã¬L in 25 minutes, with typical concentration factors between 50x and 200x and sample recoveries greater than 90 percent. In addition, the device features a "deadstop" that prevents samples from spinning to dryness. The device contains Millipore's proprietary low-binding Ultracel regenerated cellulose membrane. Available in packs of two or eight, the device is a convenient alternative to lyophilization or precipitation and dialysis techniques. For further details, contact: aditya_sengupta@milliporeindia.com NucleoCounter from Sartorius Sartorius India has launched NucleoCounter, the mammalian cell counter from Chemometec- Denmark for research and production applications. The NucleoCounter is a simple and compact instrument that combines the principle of fluorescence microscopy coupled with a CCD camera and an advanced image processing software. The sample is first treated with a lysing buffer and loaded into a cassette, which is pre-coated with Propidium Iodide, a dye that stains only the nucleus. The cassette is then inserted into the NucleoCounter and it takes only 30 seconds to perform repeatable and consistent cell count regardless of the cell type. The instrument has a high precision - CV less than five percent and a high accuracy - relative SD less than 7 percent. For further details, contact: nathalie.poirier@sartorius-india.com New launches from Greiner Germany-based Greiner Bio-One has launched High-Throughput microArraying (HTA platforms), the first polymer based platform to perform high-throughput micro arrays. The HTA Slide is able to combine the advantages of the universal microplate platform with microarrays for diagnostic applications and has been optimized for the simultaneous analysis of several samples. With 96 shallow wells and a low well rim the HTA Plate has been optimized for the simultaneous analysis of multiple samples. The low height of the rims facilitates printing a range of analytes on to the 96 wells on the plate and robotic spotters and arrayses are equipped to handle the 96 well format. During processing, a flexible wash collar creates temporary wells for hybridization and washing procedures and is immediately removed prior to detection. The company also provides a multifunctional HTA surface, which allows the ionic as well as the covalent coupling of biomolecules. By incorporating both amino and aldehyde moieties, the same polymer substrate can be used for several screening formats, such as DNA microarrays, protein microarrays and other screening applications. Greiner also provides biological protocols, utilizing reagents and biological controls developed in cooperation with Scienion AG. As per individual requirements different buffer systems (sciSPOT, sciPROCESS, etc) can be used to immobilize and analyze single or double stranded DNA, proteins or antibodies. Greiner's range of products is distributed in India exclusively by the Chandigarh-based Jain Biologicals (P) Ltd. For further details, contact: jainbio@satyam.net.in  or lalitj@sancharnet.in Carewell Biotech offers HPLC Column Oven LC-40 The New Delhi-based Carewell Biotech offers LC â€“ 40, a microprocessor controlled oven specially designed for the HPLC application. This system consists of controlling unit and heating block/oven. This unit can easily and precisely maintain temperatures from 15-70 C. Cooling /heating through solid-state peltier device (no gas/noise and extremely light weight). The control unit constantly monitors the heating block temperature and displays with the resolution of 0.1C. It also applies heating pulse even before the temperature drops below the set point thereby ensuring the constant RT under the all other constant conditions. For more details contact: info@CarewellIndia.com Ettan MDLC from Amersham Biosolutions Amersham Biosolutions, now part of GE Healthcare offers Ettan MDLC, a latest development in the range of liquid chromatography (LC) systems and the Ettan design platform, offering the dual functionality in terms of protein prefractionation and nanoscale multidimensional peptide separation of complex sample mixtures. Multidimensional liquid chromatography (MDLC) can be performed in dedicated configurations depending on sample complexity and application requirements. The new system, based on the proven performance of Ã„KTA design, provides excellent sensitivity and a wide dynamic range to allow analysis of complex mixtures containing low-abundance proteins. Ettan MDLC integrates with the Thermo Electron range of ion trap mass spectrometers (MS) and interfaces with other electrospray MS instruments, enabling efficient analysis of samples in proteomics. This integrated MDLC-MS/MS solution enables prefractionation of proteins that do not separate well by 2-D electrophoresis while also enabling reliable identification of these proteins. For further details contact: support.desk@amersham.com Pyrosequencing an established genetic analysis method from Biotage Biotage developed Pyrosequencing, an established genetic analysis method. It is based on the principle of sequencing by synthesis. It is said to be the only genetic analysis method capable of delivering real sequence information within minutes. It is also said to be an ideal choice for genetic analysis in clinical research applications, because real sequence data is the best possible assurance of a correct genetic analysis. Pyrosequencing is applied in diverse clinical research areas such as cancer mutation analysis, DNA methylation analysis, microbiological identification and antibiotic resistance studies, clinical genetics and pharmacogenetics (CYP 450 mutations). Plant genetic studies are also well served by Pyrosequencing. These applications benefit from the rapid, quantitative sequence data with built-in quality control that Pyrosequencing offers. For more details contact: info@chemito.net Alfa Laval Holding AB to establish new subsidiary in India Alfa Laval Holding AB, Sweden, an Alfa Laval Group company, proposes to establish a wholly owned subsidiary in India to undertake business activities supporting its global operations. The proposed activities are related to - research and development, global Alfa Laval Group's IT network and global IT systems in co-operation with centers located outside India, general administration particularly related to Human Resources matters outside India, supporting Alfa Laval Group engineering centers located outside India with engineering activities. Responding to the proposal from Alfa Laval Holding AB, Sweden, the Board of Directors of Alfa Laval (India) Limited at their meeting held on December 15, 2004 gave their approval and accordingly conveyed their no-objection to Alfa Laval Holding AB, Sweden to establish a wholly owned subsidiary in India.     ]]> <![CDATA[Improved mustard varieties in the making]]> https://biospectrumindia.com/news/95/1165/improved-mustard-varieties-in-the-making.html https://biospectrumindia.com/news/95/1165/improved-mustard-varieties-in-the-making.html Thu, 06 Jan 2005 16:44:00 +0530 Extensive research to increase the productivity and quality of mustard oilseed is being carried out at the University of Delhi, South Campus. Soon Indian farmers will have access to new, hybrid and high yielding mustard varieties. Hybrid mustard seeds showing more than 30 percent increase in yield are being tested at the Centre for Genetic Manipulation of Crop Plants (CGMCP) and the department of genetics, Delhi University South Campus. These potential hybrid varieties have been produced through the Cytoplasmic Male Sterility (CMS) approach both through conventional breeding as well as transgenic means. The CMS approach In mustard, a naturally occurring and suitable CMS-restorer system is not available. So compatible, high yielding parent plants are identified. Combiners having a high heterosis for yield and synchrony in flowering are chosen. Then the anthers or pollens of the seed bearing parent plant are made sterile to prevent self-fertilization. The corresponding pollinator parent plant contains a restorer gene in its nucleus, which restores fertility in all the hybrid seeds. A seemingly simple principle, but right from choosing the right parent lines to introduction of tissue specific sterility to the final production of fertile hybrid seeds is a complex interplay of genes, promoters and other associated factors. Scientists at the CGMCP and department of genetics have exploited the use of barnase (a cytotoxic male sterile gene) â€“ barstar (restorer gene) system for producing transgenic high yielding hybrid mustard seeds. The pollens of one parent plant are made sterile through the tissue specific expression of the barnase gene. The use of a spacer DNA fragment insulates the tissue-specific expression of the cytotoxic gene (barnase) and allows high-frequency generation of transgenic male sterile lines in Brassica juncea, a popular variety of mustard in the country. This cytotoxic gene produces a protein that destroys the mRNA of the system. When coupled with the restorer protein (barstar gene product) the two complementary macromolecules form a complex, which inactivates the cytotoxic protein. The barnase-barstar gene sequences have been isolated from the bacterium Bacillus amyloliquefaciens, a soil dwelling bacterium. The barnase (male sterile) and barstar (restorer) lines have been developed, which are now being utilized in the B. juncea breeding program at the CGMCP, University of Delhi South Campus, with the required permissions from the RCGM. The transgenic variety has shown more than 30 percent increase in yield in trial experiment as compared to the local varieties. The researchers have also developed viable hybrids following the CMS-restorer approach through conventional breeding too. After extensive experimentation, last year, they were able to produce hybrid seeds on a commercial basis. "Presently the variety is being tested at 14 locations in the country like in Agra, Bharatpur, Delhi, Faridabad, Rewadi, etc. In each trial, the hybrid variety is being tested on a piece of one-acre land against the local popular variety. About 30 percent improvement in the yield of the resultant hybrid plants has been noted", said Dr AK Pradhan, head, genetics department, Delhi University, "Further extensive experimental trials need to be conducted to check for sustenance of the hybrid vigor", he added. Better mustard oil The Centre for Genetic Manipulation and the Genetics Department of the University are also working on a more nutritious mustard variety. The aim being to produce a variety that can compete with olive oil in nutritional value. And significantly, the scientists have not used any genes of foreign origin, instead, they have used biotechnology to suppress certain genes in mustard. "A good quality oil should have high oleic acid (50 percent or more) and low linoleoic and linolenic acid content (about 10 percent). As a high percentage of linoleoic and linolenic acid reduces the keeping quality of the oil. The fatty acid desaturase-2 (FAD-2) gene isolated from B. campestris has been incorporated into B. juncea in an antisense orientation through transgenic approach to increase oleic and decrease the linoleoic and linolenic acid fraction from the seed oil. This antisense RNA approach is used to block the activity of the FAD-2 gene and thus a biochemical pathway, which converts oleic acid to linoleoic acid", explained Dr Deepak Pental, professor of genetics and director, University of Delhi, South Campus. The preliminary evaluation of first generation transgenic plants has indicated increase of oleic acid (up to 73-76 percent) in B. juncea lines. Presently this potential line is being grown on a small scale in containment. Next year the scientists plan to take the necessary approvals from the government bodies and produce transgenic seeds for larger trials and toxicology and allergenicity testing. Improved oilcake Research is on to improve the quality of the oilcake also. Normally the oilcake left after extracting the mustard oil is very high in glucosinolates, which makes the oilcake pungent and unfit for poultry and animal feed. Presently, per gram of oilcake contains about 100 micromole of glucosinolate, which should be reduced to 30 micromole, if the oilcake is to be used. There is a high demand for such oilcake in the international market. Efforts are on at the genetics department to develop mustard seeds with low glucosinolate levels. The East European mustard gene pool which contain a large number of useful characters like '0' erucic acid and low glucosinolate traits and shows significant levels of heterosis in hybrids with Indian varieties is being used. Since the production of glucosinolate is through a very complex biochemical pathway involving 6-7 genes, the scientists are using the doubled haploid microspore approach for producing such plants. And in order to retain the essential Indian characteristics in the hybrid variety recurrent back crossing is being done. It is expected that in the next 3-4 years low glucosinolate level plants will be ready for the farmers. "Presently we are creating hybrid varieties having individual good traits and later all these traits will be converged into a single plant," elaborated Dr Pradhan. Rolly Dureha Stem cell therapy: Rekindling hopes Stem cells may be the proverbial silver bullet offering a ray of hope for medical conditions, previously considered beyond cure. For the first time ever, South Korean scientists are reported to have used stem cell therapy to make a paralytic women walk again after 20 years. Thirty seven year-old Hwang Mi Soon was bedridden since the past two decades after damaging her back in an accident. The researchers repaired her damaged spine using stem cells derived from umbilical cord blood. And Mi Soon was able to take tentative steps once again with the help of a walking frame. This is the world's first published case where treatment of spinal cord injuries was successfully done with stem cells from umbilical cord blood. For the therapy, multipotent stem cells were isolated from cord blood, which had been frozen immediately after the birth of a baby and cultured for a period of time. Then these cells were directly injected to the damaged part of the spinal cord. Of late, the scientists have coaxed these primordial cells to transform into a variety of specialized cells to treat a range of diseases. For instance, scientists at the University of Toronto have found that stem cells have the potential to restore vision in older people suffering from macular degeneration. The researchers found that human retinal stem cells regenerated when they were transplanted into the eyes of mice and chicks. They now plan to see if the same happens in diseased eyes in the hope of eventually treating humans. The researchers have said that stem cells taken from the back of the eye could eventually be used to restore normal vision in people with sight problems. These findings have appeared in Proceedings of the National Academy of Sciences. Harvard scientists have manipulated stem cells already present in the brains of mice to induce the birth of new neurons, an advance once considered impossible by most scientists. They induced the birth of new cells by killing nearby neurons in mice, which set off a cascade of events that led to stem cells producing new neurons in the cerebral cortex. If scientists can turn this into a therapy for humans, it would mean that patients could literally heal themselves with stem cells already present in their brains. They hope experiments like this would lead to new ways to grow neurons. Simultaneously, a team of Italian neurosurgeons and scientists are looking at stem cells from skin to fight brain tumors. They are looking into whether stem cells derived from a brain tumor patient's own skin can be used to fight the tumors. The researchers successfully grew stem cells from skin samples of adult patients with brain tumors. It is hoped that these cells can then be used as a new brain tumor therapy, which has been attempted successfully in mice. They found that mice with brain tumors that were treated with stem cells showed both increased blood supply and decreased tumor growth into the surrounding brain. These mice also lived on average 50 percent longer than mice that were not given this therapy. Meanwhile, researchers at the Howard Hughes Medical Institute (HHMI) have isolated stem cells from the skin of mice and shown that they have the power to self-renew and differentiate into skin and functioning hair follicles when grafted onto mice. The findings mean that the human equivalent of these stem cells, which scientists are also trying to isolate, could ultimately be used to regenerate skin and hair. In another unique discovery it has been found that embryonic stem cells have the capacity to influence neighboring defective cardiac cells and restore their capacity to function normally. Researchers at Memorial Sloan-Kettering Cancer Center have reported that 15 embryonic stem cells injected into early embryos of mice whose hearts were genetically predisposed to develop a lethal defect, rescued the heart from developing the disorder by not only producing normal daughter cells that were incorporated into the defective embryonic heart but also by releasing biological factors into the nearby vicinity. This prevented neighboring heart cells from developing into defective tissue. These experimental findings indicate that the potential of stem cell therapy is slowly unfolding now and in the near future it may become the choice of treatment for many, if not all, difficult irreversible diseases. Rolly Dureha   ]]> <![CDATA[Mashelkar Panel Draft Report Ready]]> https://biospectrumindia.com/news/95/1293/mashelkar-panel-draft-report-ready.html https://biospectrumindia.com/news/95/1293/mashelkar-panel-draft-report-ready.html Thu, 06 Jan 2005 16:41:00 +0530 A national task force headed by CSIR chief Dr RA Mashelkar was set up in April 2004 to streamline the regulatory process involved in the approval of all recombinant DNA products. The Ministry of Environment and Forest (MoEF), which oversees the regulatory agency, Genetic Engineering Approval Committee (GEAC), had issued the notification for setting up the task force on April 20. The task force, which was asked to submit its report by May 2004, had the 12 members as part of the panel. The first meeting of the Task Force was held on May 12, 2004 and subsequently the task force met the industry and other stakeholders at several levels. The draft report of the Task Force on recombinant pharma is now ready. Dr Dhananjay Patankar, head, biotechnology, Intas On setting up the panel, industry leaders welcomed it and quickly evinced their suggestions to help the task force with the tasks ahead. Now that the draft will be circulated, industry has few quick comments to offer on the same. Four great developments emanate from this report said the South Asia Office of The International Service for the Acquisition of Agri-biotech Applications (ISAAA). GEAC will not have a say if the final product doesn't involve LMOs. Most of the recombinant pharmaceuticals don't have living organism in their final products (only protein derived from LMOs/GMOs). It will be a savior for biotechnology industry. GEAC's role would be limited to inspection (if fermentation capacity is over 20l) only. Reversely, anything that involves LMOs/GMOs would come under the purview of GEAC irrespective of its risk categories. The report will have, if any, adverse impact on the growth of agricultural biotechnology. Constitution of Inter-ministerial Standing Committee on biotechnology regulation to address issues and anomalies concerning recombinant pharma that have never appeared before. It would strengthen coordination among different ministries and smoothen the process for approval of innovative products to be come in the market. Task force vehemently recognizes the importance of an independent institutional mechanism called National Biotechnology Regulatory Authority. Since both Prof. Swaminathan and Dr Mashelkar recognize the need to develop strong institutional structure and scientific body i.e., NBRA, the government must evolve this process rapidly to give fillip to investments and trade in biotechnology products. Protocol V would be detrimental to Indian biotechnology industry and dumping of biotech products in India. Eventually, it would promote "trading" than "innovation" in our country. Since the final recommendations have not been made public yet, the comments to each of the individual points in the recommendations is difficult to make said Dr Dhananjay Patankar, head, biotechnology, Intas Pharmaceuticals Ltd. However, he made some general comments. We are overall quite satisfied with the draft recommendations of the Mashelkar Task Force. The main concerns of the industry in the existing framework was that various committees were looking at the same data, often outside their area of expertise, thus causing duplication and redundancy and delays. Further, there was a problem of infrequent meetings of the committees. The draft recommendations have streamlined the procedure such that different committees examine the data that fall under their field of expertise and there is no unnecessary duplication. The different committees like RCGM, GEAC have also on their own already increased the frequency of their meetings and increased their communication with the companies. We are very happy about the way the government has really responded to the industry's concerns and brought about simplification of procedures without diluting the stringency of the regulatory scrutiny of the data before according approval to products. For registration of imported biotech products, however, we have one further suggestion to the DCGI (although this was not under the scope of the Mashelkar Task Force). We believe that the DCGI should insist on inspection of the manufacturing facilities and GMP aspects of the manufacturer whose product is to be imported. As of now there is no such provision, and thus we cannot be sure of the quality of the production system of the manufacturer. The expenses for carrying out inspections can be recovered through application fees charged to the importer. The domestic manufacturers adhere to strict GMP regulations as per Schedule M but there is no method for ensuring that the foreign manufacturers are adhering to such quality systems. Dr Dhananjay Patankar, head, biotechnology, Intas Dr Prasanta Kumar Ghosh, senior vice president, Cadila Pharmaceuticals Ltd, Ahmedabad, who had served in various key positions in the government and retired as advisor from the DBT in May 2002, in his personal capacity, observed that the Indian rules on GMOs were framed when the knowledge base on nucleotide sequences including the promoters, the enhancers, terminator sequences etc. were inadequate. Information on safety of complete coding construct and transformed host were also inadequate. With the advent of knowledge, review of the Rules has become imminent. In that context the work of the Task Force (TF) is very relevant. He added: "The TF is mandated essentially to recommend a transparent and streamlined regulatory mechanism and a regulatory process including mechanism for the use of LMOs in the pharmaceuticals industries as also for import of LMOs by the pharma sector. The analysis of the regulatory framework by the TF seems to somewhat myopic and the essence of the strength of the current framework of the regulation has largely been missed out. Few problems identified in the analysis seem to be supposition and some of the conclusion appears to be inexact." Ghosh pointed out: As regards the recommendations appearing on Para 5 of the draft report the existing system has been found to be workable and largely status quo has been maintained for the roles of IBSC and RCGM (Para 5.1a and 5.1b). For recommendation at Para 5.1c, it has been stated that for the review of LMOs, GEAC will take note off or approve only the containment facilities for the use of LMOs including more than 20 liter fermentation capacity where the end product is a purified material intended for commercialization. This recommendation does not seem to be scientifically consistent with LMO substances containing nucleotide sequences consisting of coding sequences with or without promoters and terminator sequences. Presence of such sequences in adequate quantities in the purified finished product could be potentially harmful. For this recommendation, I think it should be modified for LMO substances for which there is no pharmacoepial specification and yet the nucleotide sequences are present in quantities less than 100 picogram per dose. In Para 5.1d, it has been stated that the DCGI would examine animal toxicity, allergenicity and QC data. Here too the recommendation need to be modified to include only those LMO drug substances that have been incorporated in Indian Pharmacoepia or in any other Pharmacoepia accepted by the Indian authorities. In recommendation Para 5.2a, it has been stated that "It was agreed that... for conducting Phase III human trials". The conclusion seem to be inconsistent with the existing law the reason for the GEAC to state that it has no objection to the conduct of trails on human including Phase I or Phase II or Phase III or Phase IV when GEAC is satisfied that the animal safety data generated by the applicant indicates that the product is reasonably safe. GEAC works under EPA and it has been the responsibility GEAC to examine whether a pharmaceutical product derived from LMO is safe to human and animal. Safety information emanating from the presence of Host DNA and Host nucleotide sequences as well as trans nucleotide sequences are within the purview of GEAC under Indian EPA. The recommendations at Para 5.2 a 2,3,4 seems to be okay and they are consistent with sound logic and good argument. These are also being generally followed presently. Recommendation at Para 5.2a 5 do not seem to be okay for new drugs derived from rDNA technology. These can be okay for Pharmacoepial drugs only. The recommendations at Para 5.2b2 does not seem to be correct as the presence of large quantities of the coding sequences can be potentially dangerous to human health. The recommendation at Para 5.2b3 is consistent if it is a Pharmacoepial drug. This recommendation is therefore not required for situations where LMO's are Pharmacoepial drugs. Recommendations 5.2b4 is also inconsistent with LMO drug that are Pharmacoepial The recommendation at Para 5.2c on import and marketing of recombinant Pharma products also needs to be revised and perhaps for recommendation on 5.2c1 it can be stated that for import of recombinant pharma products where the presence of Host DNA or the transgenic DNA is less than 100 picogram each per dose, GEAC approval is not required. Otherwise all such substances should require GEAC approval. Obviously, Pharmacoepial LMO products will not require approval of GEAC. Para 5.2c2 can be modified to incorporate that LMOs approved in any acceptable Pharmacoepial will not require GEAC approval. He suggested the report could have been made much more simplified by excluding: All substances produced by LMOs where the substances are so pure that the presence of transnucleotide sequences as well as Host related proteins and DNA are not detectable by standard scientific practices All Pharmacoepial drugs including LMOs and products thereof would not require the approval of GEAC. Dr Dhananjay Patankar, head, biotechnology, Intas GEAC could also publish a list of nucleotide sequences, pharmacoepial drugs produced by rDNA technology, as well as other GRAS organisms on which there is no known environmental risk as exempt from the GEAC provisions. These would simplify the situation substantially he noted. Rajesh Jain, joint managing director, Panacea Biotec Ltd, has his share of suggestions for the draft report on specific issues. Containment facilities Inspection and approval of containment facilities (less than 20 ltr) may be provided by IBSC. RCGM may be involved in inspection and approval of containment facilities with capacity of more than 20 liters. GEAC may not get involved in approval of containment facilities. Clearance of proposal using various risk category organism All proposals using a category risk II microorganism be examined and approved by IBSC. The organisms under category I risk are non-pathogen and are exempt for any clearance. The proposals using organisms belonging to category risk III, IV or higher risk be first examined by IBSC and recommendations may be made to RCGM for approval. Pre-clinical toxicology protocol/data RCGM should restrict its role in examining the proposal relating to the specifications, characterizations and information on rDNA biologicals materials. The RCGM should consider providing permission for generation of preclinical toxicology data. The preclinical toxicology protocol to be used would vary depending upon the requirements and products and such protocols are usually designed after discussion with appropriate laboratory or center involved in conduction of clinical trials. Therefore the precise protocol to be used would ideal be left to the investigators. The preclinical toxicology data so generated be examined by "rDNA expert committee" located in the DCGI office. Strengthening of IBSC and rDNA expert committee In both of these committees, the nominee of GEAC may also be included as member, so that all aspects relating to environment could be addressed at the initiation of the proposal and during examination of the data so generated. Nonetheless no one is disputing the fact that the Mashelkar report is a sincere attempt to examine various issues and find reasonably sound solutions given the mandates of different authorities involved. "It is good that importers of biotech products (rDNA not containing LMOs) need not seek GEAC approval. Indigenous manufacturers now have a structured process and will benefit from IBSC, RCGM, RDAC and DCGI as long as timelines for approval are met. There is need for a stricter mandate on meeting timelines. The intention to provide impetus to the Indian industry is seen in the report but actions have to match it specially the pace with which each independent authority operates. The inter-ministerial committee on BT regulation is forward looking and if the single window approach could become a reality through National Biotechnology Regulatory Authority (NBRA) similar to US FDA it would be a boon and indeed pave the way for a brighter future for the Indian industry," informed Rajiv Gulati, MD and Chairman, Eli Lilly India. Srinivas Rao Draft Report of The Task Force on Recombinant Pharma Key Recommendations 5.1 Roles of regulatory authorities and decision-making criteria under Rules 1989 of EPA and Drugs & Cosmetics Act, 1945. a. IBSC to note, examine and approve proposals involving r-DNA work; to ensure adherence of r-DNA safety guidelines 1990 of Government; inspection of containment facilities at R&D and production units and to inform the RCGM about the facilities; to prepare emergency plan according to guidelines; to approve experiments utilizing the organisms and genetic elements from Risk Group-I and II organisms up to laboratory fermentation 20 ltrs capacity with intimation to RCGM; for using organisms falling in Risk Group III and above, IBSC to recommend to RCGM for approval to conduct laboratory studies; to recommend for import/ exchange of GMOs/LMOs, vectors, gene constructs, plasmids, etc., for research purposes; to act as a nodal point for interaction with statutory bodies; to examine the description of the target gene and source; nucleotide sequence and amino acid sequence of target gene and the target protein; the composition of the vector used; schematic diagram of the expression cassette; restriction map of vector indicating the location of the target gene; cloning strategy; description of the host cell line including genera and species; risks involved in handling of cell line; methods of maintenance of cell line; classification of the host cell line as per the guidelines; to examine protocols for toxicity/allergenicity studies as per national and international guidelines and their recommendations to RCGM. b. RCGM to examine information on preparation of MCB and WCB; QC tests conducted on the cell line; approaches adopted for expression of target gene in the host cell line; genetic analysis including copy number of inserts, stability; level of expression of target gene; description of production process; growth kinetics; fermentation parameters; in-process control measures; quality control & quality assurance data; approaches adopted for extraction and purification of the target gene product; examine data on physico-chemical, biochemical, immunological and pharmacological characterization of the bulk; characterization of the finished formulation; acceptability criteria for bulk and formulation as per IP, USP, BP or other national/international specifications etc; efficacy tests on the target product; trial batch fermentation data on the product; estimation of contaminants like DNA, RNA, lipids, carbohydrates, proteins etc, derived from the host organism and any toxic processing materials in the product; to approve the protocols for conducting animal toxicity and allergenicity studies and examination of in-process and final QC data on the product etc; inform and recommend to the GEAC about the containment facilities at R&D and production sites. c. GEAC will take note of/approve only the containment facilities for the use of LMOs, including more than 20 lts fermentation capacity, if the end product is a purified product like antigens, proteins or any therapeutic/prophylactic product intended for commercialization. It will confine its regulatory role in terms of product approval only if the end products are living modified organisms (LMOs) per se in terms of risk vs. benefit analysis. In this context GEAC to approve activities involving large scale use of LMOs; industrial production and application; permit to use LMOs for commercial applications; authorize large-scale production and release of LMOs into the environment; adopt the procedures for restriction or prohibition, production, sale, import and use of LMOs for applications under EPA; authorize agencies or persons to have powers to initiate punitive actions under EPA on defaulters. d. DCGI would examine animal toxicity and allergenicity and QC data; examine the protocol and recommends conduct of human clinical trial; examination and approval of clinical trial report; approve for production of trial batches; accept of Test Reports from CRI, Kasauli; final approval to manufacture and market. 5.2 Procedure Recommended in the biosafety regulations of LMOs and the products thereof for indigenous development as well as imported products. a. Indigenous Product Development, Manufacture and Marketing of pharmaceutical products derived from LMOs: 1. There is no overlapping of regulatory objectives up to the pre-clinical evaluation of the data generated by the applicant on the recombinant pharmaceutical products derived from LMOs. It was agreed that there is no need for obtaining approval from GEAC for conducting phase III human clinical trials. The general consensus was that it is the mandate of DCGI to look into the pre-clinical and clinical data for assessing the efficacy and safety of the product. Therefore DCGI only may accord approval for conduct of human clinical trials. 2. RCGM to continue the practice of examining the protocols and pre-clinical data submitted by the applicant and forward their recommendation to DCGI for consideration of granting approvals for human clinical trials and simultaneously, endorse a copy to GEAC for information and record. 3. RCGM, based on the report of IBSC to send information to GEAC about the adequate containment facilities installed for handling LMOs during R&D and production by the applicant. GEAC in-turn takes cognizance of the information. 4. However, approval of GEAC would be required for the containment facility involving use of LMOs during the product development and manufacturing of recombinant pharma products utilizing more than 20 liters fermentation capacity. 5. RDAC in DGHS to approve the protocol and recommend to DCGI for conducting phase-I to phase-III human clinical trials; the clinical trial data is to be directly submitted to the DCGI by the applicant. DCGI is to examines the Human Clinical Trials data and approve the marketing of the product as per the Drugs and Cosmetics Act & Rules and endorse the information to GEAC for record. b. Indigenous Product Development, Manufacture and Marketing of LMOs as pharmaceutical products: 1. RCGM to continue the practice of examining the protocols and pre-clinical data submitted by the applicant(s) and forward their recommendation to DCGI for further necessary action for human clinical trials. Based on the report of IBSC, RCGM to send information to GEAC about the adequate containment facilities installed for handling LMOs during R&D and production by the applicant. GEAC to take the information on record. 2. The GEAC will confine its regulatory role in terms of product approvals only if the products are Living Modified Organisms (LMOs). GEAC will be responsible to evaluate the environmental impact caused by handling and use of LMOs, assess environmental risks within certain pre-determined limit and estimate the benefits that are likely to accrue to society. 3. DCGI to examine the data on the toxicity, allergenicity and other QC tests through the Recombinant Drug Advisory Committee (RDAC) for approval to conduct human clinical trials under Drugs & Cosmetics Act and Rules and to recommend Phase-III clinical trials. 4. When an LMO per se is to be used as a product, GEAC is also to approve Phase-III human clinical trials based on risk/benefit analysis as well as approve for the environmental release under Rules-1989 of EPA c. Import and marketing of recombinant pharma products: 1. Import of recombinant pharma products, which do not contain an LMO in the end product approval of GEAC, will not be required. 2. In the case of import of LMOs per se as products, GEAC will be responsible to evaluate the environmental impact caused by handling and use of LMOs, assess environmental risks within certain pre-determined limit and estimate the benefits that are likely to accrue to society. Based on the assessment it would recommend to DCGI for environmental release and commercialization of LMO pharma product. 5.3 The time lines for approvals: 5.3.1 A consensus on the following timelines emerged for various approvals by the regulatory authorities. â€¢ RCGM approval for pre-clinical animal studies: 45 days â€¢ RDAC approval for Human Clinical Trials protocol: 45 days â€¢ RDAC (DCGI) examination of trial data and approval: Case specific â€¢ Simultaneous DCGI & GEAC approvals: 45 days 6. Other issues 6.1 On the issue of seeking approvals of PPA/DCGI/GEAC under Rules 1989 of EPA and PQO by Customs Authorities on the imports of GMOs/ LMOs for R&D purpose it is suggested that the earlier practice of permitting the import with the approval of RCGM should continue and PPA/DCGI to issue instructions to Custom Authorities to clear the consignment based on RCGM's approval. 6.2 Regarding the constraints faced by the industry for import of non-GMOs, PPA may issue instruction to Customs Authorities to clear the consignment based on the declaration of the importer/exporter on certification of the nature of the non-GM organisms etc. 8. Proposed independent institutional mechanism-National Biotechnology Regulatory Authority/Commission. 8.1 It was suggested that it would be desirable to establish an independent professionally competent authority, if possible, for providing single window approvals. One of the models for National Biotechnology Regulatory Authority/Commission (NBRA), similar to the FDA system was proposed by Secretary DBT in the second meeting of the Task Force held on 15th June 2004. The proposed models recommends that the NBRA would comprise of four wings namely: a) Agricultural products / Transgenic Crops b) Pharmaceutical/ Drugs and Industrial Products c) Transgenic Foods/Feed and d) Transgenic Animals/ aquaculture. The four wings of the authority would be managed by professionals who have been well trained in regulatory affairs. This will facilitate more interactive regulatory process. A Vice Chairman would head the four wings of the Secretariat. The recommendation of the Secretariat would be forwarded to Apex Committee with Statutory Powers. The members of the Apex Committee would comprise of representatives from all stakeholders Ministries/ Departments. The Apex Committee would report to the Chairman. The proposed model for NBRA is given at Annexeure-VII. 8.2 Alternate models of how a national biotechnology regulatory authority can be created also need to be examined. The group believes the creation of a professionally managed single authority would send a strong signal to international community and promote trade and investment as well as ensure timely and effective regulation. (Note: This is not the full report. The draft report in its entirety will be available on www.biospectrumindia.com) ]]> <![CDATA[Industry Wants Predictable Biotech Policies, Regulations]]> https://biospectrumindia.com/news/95/2595/industry-wants-predictable-biotech-policies-regulations.html https://biospectrumindia.com/news/95/2595/industry-wants-predictable-biotech-policies-regulations.html Thu, 06 Jan 2005 16:40:00 +0530 The national biotech policy would be drafted by a 27-member committee headed by Dr MK Bhan, secretary, Department of Biotechnology (DBT). The policy is likely to be announced in January 2005. Discussions and parleys are on to arrive at a comprehensive policy. BioSpectrum hosted a quick roundtable on the eve of "BioSpectrum Awards Nite" on December 10, 2004 as Dr Bhan and several other leading industry leaders confirmed their presence to attend the function. And this could serve as a forum to make some quick suggestions for the Policy-in-making. Dr Cyrus S Poonawalla speaking at the panel discussion on the proposed national biotech policy. In fact Dr M K Bhan said that the awards nite function had provided a good platform for him to seek inputs from many luminaries for the biotech policy draft. "India has a broad science and technology policy and DBT has drafted a document which describes a vision for development policy. We came to the conclusion that what we required was a conceptual policy framework within which we could conceive a set of actions that would give this industry the enabling environment it deserves to enhance its potential. The whole effort has two features. It will endorse the vision that was enunciated for biotechnology and suggest a policy framework for development of biotech industry," he said. Emphasizing that it was not a policy for biology or science but it was a policy for the biotech industry, for its promotion and for creating an enabling environment, Dr Bhan said science was a key instrument in the development of biotech industry and hence there was a need to look at challenges ahead in R&D and other challenges through the eyes of the industry. "We should come up with a framework within which we should think about the development of the biotech industry and come up with concrete actions that for us would be a blueprint on which to act. The major role in framing of this policy comes from focused groups. Initially, we did not want to get drowned in sectoral concerns. We looked at areas like human resource, financing, trade and fiscal incentives, infrastructure, promoting innovation, commercialization, regulation, intellectual property and public trust. We then discussed that there may be a special need of sectors. We also asked groups of people to give us strategic papers of recommendations on specific sectors like agriculture etc. The initial focus is on cross-cutting areas and sectoral areas. We have learnt from people in the industry that there cannot be a framework forever," Dr Bhan stated. He added that there was a need to revisit the framework once in every five years in the next 10 years, as we need to look at a different base and a different denominator and focus on the changes. Moderating the discussion on the proposed national biotech policy, Kiran Mazumdar-Shaw, chairman and managing director, Biocon Ltd, said, "We have seen a lot of interest and activity in the sector of biotechnology in the last 12 months and we have taken very important initiatives such as streamlining of the regulatory policies for agribiotech and pharma biotech by the two task forces headed by Prof. MS Swaminathan and Dr Mashelkar. Further Kapil Sibal, minister of state for science and technology, has initiated the process for a very comprehensive and pragmatic biotech policy. India has an enormous opportunity in biotechnology," said Mazumdar-Shaw. Stressing on the importance of recognition of these opportunities by the government, Mazumdar Shaw said that the willingness and eagerness on the part of the government to enunciate a very comprehensive biotech policy was a step in the right direction. "One of the ways Dr MK Bhan, secretary, DBT, has been going about at looking at this particular area is to segment it at a macro level into various components and one of these components is the area of the bio business. Dr Bhan has played a very important role in getting together the industry, academia and the government to look at what is required to ensure the growth of the biotech industry," she opined. Sharing his thoughts, Dr KK Narayanan, managing director, Metahelix Life Sciences, said it was very thoughtful on part of BioSpectrum to have provided a platform for continuing the process of consultation for formulating the national biotechnology policy. "India is primarily an agrarian economy. So we cannot overemphasize on the importance of agriculture in this country. We have the second largest area of crops in the world next to the United States. But if we look at the productivity of the various crops in this country, we would probably rank among the lowest." Dr Narayanan cited that China, which had about half the area under cotton cultivation as compared to India, produced twice as much as that India produced. Stressing on the need for increasing the productivity and the nutritional quality of crops, he said, "Biotechnology is a very powerful option and we need to foster responsible crop biotechnology." Elaborating on a couple of aspects that Dr Narayanan felt had to be reflected in the policy, he said, "In terms of research in agricultural biotechnology, India has tremendous resources and capacity but the problem is that it is fragmented. There are several national public institutions under the Indian Council of Agricultural Research, state agricultural universities, certain institutes of the Council of Scientific and Industrial Research (CSIR), which are actually doing cutting edge research." "In the last few years, several private institutions, companies and non-governmental organizations (NGOs) have also been involved in developing technologies which are very relevant for agriculture in this country. We have not been able to synergize the different efforts made by these various institutions-be it public-private partnership, public partnership, or private-private partnership to get maximum mileage. So there is a need to make the most of the combined efforts of these institutions," he observed. "Another very important aspect is the regulatory system. I have been deliberately using the word 'responsible crop biotechnology'. There needs to be proper regulation of this technology to make sure that the technology is being developed and used responsibly and for that we need a good regulatory framework in this country for approving biotech products, particularly in the area of agriculture. The Prof. MS Swaminathan Task Force has actually recommended a certain framework-they are specific recommendations and if implemented, will go a long way in making a good regulatory system in this country," he concluded. Dr Ferzaan Engineer, CEO of Quintiles, said, "In the last seven years, we have been seeing increasing interest in clinical trials and a lot of international work has been coming to India. Particularly in the last one or two years, we have seen a strategic shift in the thinking of our major customers. We have seen a strategic focus on the substantial percentage of their clinical work being moved to relatively new geographies and India is one of the most important geographies. I am concerned that our regulatory infrastructure may not catch up as quickly as one would like. We may be flooded with work but we may not have the necessary staff and the infrastructure at the regulatory level. So my first concern is how do we scale the regulatory infrastructure to catch the opportunity which I believe is coming our way. Another aspect is the fact that by and large the changes that we have been talking about, do not take into account the new biology. If we are moving towards a more opus framework then it makes sense to take full cognizance of the drugs being derived from new biology and gene therapy. Also we need to come up with a single window system which is fast, transparent, efficient and science-based with a pace and vigor to make us globally competitive and meet expectations of public trust." Dr Cyrus S Poonawalla, chairman of the Serum Institute of India, echoed similar views with regard to the single window clearance system and also spoke on regulatory approvals. "A lot of talk has been happening in the past several weeks about single window clearance system but this still remains a dream. And in short it is the real answer. The regulatory affairs have so far suffocated the biotech industry, specially the genetically engineered products. The industry could be encouraged by having a single window clearance system and this can be done by taking into confidence all the departments which could have one representative in a committee which would then jointly take decisions and clear applications from aspiring biotechnologists and also look into product approvals," Dr Poonawalla suggested. Commenting on the funding mechanisms, Dr BV Ravikumar, managing director, XCyton Diagnostics Ltd, said, "The biotech sector unlike many others is very R&D-dense. For some reason we have been very reluctant to fund R&D. We are reluctant to take the risks involved. Hence there is a need to create a public funding system." Responding to the ideas and thoughts that were put forth by the speakers, Kiran Mazumdar-Shaw said that most of the problems had been addressed to a certain extent. "The Mashelkar Task Force recommendations are looking at streamlining the entire regulatory process and we are contemplating an inter-ministerial single window platform which will address key aspects of regulation but otherwise the regulatory process itself has been simplified quite extensively. One may not really have to approach the GEAC for product approvals. Being a member of the task force, I can say that from the industry's point of view we have made a lot of progress on the regulatory aspect. Another aspect is that we are addressing small business grants for embryonic funding and these are the areas we are going to be looking at. The infrastructure required for the entire regulatory framework tops the agenda. It will be an evolutionary process. The first draft of the policy will be a broad brush and then from which we have to build on in terms of specifics." In his concluding remarks, Dr Bhan said that of the many thoughts that were echoed, some were easy to implement while the others needed a little negotiation. "The key lies in working together in getting the government to agree to the challenging ideas," he said while giving a call to the people in the industry to voice their concrete ideas. He also suggested that BioSpectrum in its next print issue as well as its website could provide a link to the website of the Department of Biotechnology, accessible at http://dbtindia.nic.in/ so that people could post their views online. Namratha Jagtap   ]]> <![CDATA["The future belongs to Proteomics"]]> https://biospectrumindia.com/news/95/1935/the-future-belongs-to-proteomics.html https://biospectrumindia.com/news/95/1935/the-future-belongs-to-proteomics.html Thu, 06 Jan 2005 16:27:00 +0530 Hemant K Gupta, president, Axygen Scientific How will Axygen position itself in the future? In the year 2005-06, the focus of Axygen will be on genomics, proteomics research and Real Time PCR products. With the completion of the human genome sequencing, the present era belongs to genomics. And proteomics is the future. In a protein study, scientists have to clarify the protein, purify it and then crystallize it for further studies. Presently, we are working on the crystallization technology and will commercialize a product in the next two months. This will facilitate the scientists in obtaining vital pieces of information and data for further interpretation. In India, Axygen would be focusing on the cell and tissue culture and proteomics products. Essentially we are widening our products base and are focusing on niche new R&D intensive segments. Beyond 2006, we would be developing some new instruments for the life sciences sector. Can you tell us about the genesis of Axygen I started Axygen in 1993 in the US in a small garage. Then the biggest hurdle that I faced was inadequate capital funds but that did not stop me. Within a span of two years, we showed good growth and moved into an office where we planned to stay for 15 years. But in the next 6 years we outgrew that office too. Today we have moved into our new facility, which we have planned for the coming 20 years. Our company is a technology driven innovative organization. Today our total strength is of 382 people and the revenues of our total operations as a group has more than doubled during the past year whereas the internal organic growth of Axygen in terms of revenues is about 37 percent during the past year. How is the market penetration of Axygen? Our product range is expanding and our market share is increasing. Presently the growth rate of the industry is 8-10 percent worldwide, but our company is growing at 35-40 percent, which shows that we have captured a major market share. We have an office and a production unit in Japan, China, India and the US, which is our headquarters, and soon we will be looking into Europe. Our products are being distributed in North America, South America, European Union, Asia, Australia and we have just entered Russia. Our goal is to bring Axygen to the top and I think we will. We have recently acquired a company in China, which is into DNA and PCR purification kits, DNA markers, etc. We have infused a lot of capital and technology into the company. And soon we will be producing new product lines that we were earlier shipping from the US to China. How is the biotech industry in India developing? In India the life sciences and biotechnology market is very promising and will grow many folds. It is just the start right now and we have only scratched the surface. But if India has to come up, the general infrastructure of the country has to improve. Red tapism and bureaucracy are the biggest problems in India. These should change! The problems start right from shipping the product from overseas, getting them here, the duties involved, etc. We do not have these problems in any other country, not even in China. For instance, shipping of consignments to India still takes an enormously long time, as long as 90-120 days whereas in China the same just takes 17-20 days. Rolly Dureha "There is a good market for every one who is making quality products" Dr G Ramakrishnan, director, Asia Business Development for Scientific Instruments Division, Thermo Electron Corporation What made you to join Thermo Electron Corporation leaving Agilent Technologies? I started my marketing career by selling mass spectrometers for the first time in India for Hinditron in 1981. After many years of working on different technologies and products, I am now getting an opportunity to again play a role in marketing of mass spectrometers at Thermo Electron Corporation. And I am also excited to be a part of Thermo Electron which is a major technology product manufacturing company in the world, catering to the needs of different industries with a whole lot of product ranges under the lab and laboratory sciences division (clinical diagnostic division, bioinformatics division, scientific instruments division, bioscience division) and process instrumentation division. Mass spectrometer is leading the drug discovery, clinical chemistry research and proteomics. There is tremendous opportunity in these areas, which in turn will push the growth of mass spectrometer market in India. Thermo is supplying the best mass spectrometers in the country and will a play major role in the growth of the life sciences sector. How you foresee the growth of biosuppliers market? The market size for Liquid Chromatography Mass Spectrometer should be in the range of $ 25 million in India growing at 25-30 percent. In the next 3 â€“4 years the growth rate will be even higher. The HPLC market is expected to grow more than 35 percent as HPLCs go a lot into the life sciences industry. While the growth of gas spectrometers is about 10 percent. As a calculated guess the analytical instruments sector in life science is expected to see an average growth rate of 15 percent. However, it depends on the instruments/equipments used in life sciences industry. As life sciences industry requires a lot of products it is difficult even to make a guess on the market size from the supplier side. However, considering just the market size of the analytical instruments it would be around $100 million growing at the rage of 25 percent. This is mainly because many companies coming up in clinical research, proteomics and drug discovery areas do require different types of spectrometers. Although there are many leading players in this field such as Thermo Electron Corporation, Applied BioSystems, Waters, Micromass, Agilent Technologies, there is good and healthy competition. The only difference between Thermo and others is that the later do have products in mass spectrometers but don't have the variety/range of products. What are key the challenges? In order to cope up with the increasing demand for technical people, we do require skilled and trained pharma graduates, engineers, biochemists and biotechnologists. I hope that a lot of investments will be made available by the government bodies like DBT, DST, CSIR, and UGC to fund the institutes that offer training in specialized field. Even private institutions are developing good engineering and medical colleges that can really produce good talents. However, I see some kind of braindrain in biosuppliers sector as more foreign companies are recruiting skilled people. The biosuppliers sector is really in need of good and technical qualified people both in sales and services. There is a scope for providing training to the juniors and graduates. Lack of skilled people in the sector is pushing them to look for newer offer very often. The movement is at an alarming rate. Hence retention has become a tough task. They have to look at providing training to the junior chemists so that they can take up newer challenges to compete in the market. Although there is a good and healthy competition in the field, the major challenge will be to build a good infrastructure to serve the customer better. As there is drop in the import duties on life saving equipments, imports have become much more easier. But a lot of procedures are involved which need to be followed up and this results in the delay in importing the equipments/instruments and spare parts. Companies do have to keep inventory of spare parts so that the down time can be minimized. Hence maintaining the inventory of spare parts is also one of the challenges as the companies depend on imports. In all, hiring good people, getting them trained about the upcoming technologies and retaining them, establishing good customer value preposition and customer satisfaction are key challenges before the sector. Narayan Kulkarni ]]> <![CDATA[Genome Valley to host BioAsia 2005]]> https://biospectrumindia.com/news/95/2767/genome-valley-to-host-bioasia-2005.html https://biospectrumindia.com/news/95/2767/genome-valley-to-host-bioasia-2005.html Thu, 06 Jan 2005 16:25:00 +0530 BioAsia 2005, the annual global bio business forum, will be organized from February 10-12, 2005 in Hyderabad. Watch Out Trade Show: The international tradeshow will enable business transactions and facilitate exhibitors from all over the world to showcase their products and services. A total of 550 sq.m is allocated for exhibition space of which 222 sq.m has already been booked by prominent sponsors like Sun Microsystems, Bharat Biotech, Amity International, Suven Life Sciences, ICRISAT, Ocimum Biosolutions, Magene Life Sciences, British Trade Office, Finpro and IGCC. Conferences: Leading experts in biotechnology are expected to make presentations on the advances in their fields at BioAsia 2005 conferences. More than 60 internationally acclaimed speakers representing countries like Switzerland, United Kingdom, Singapore, Israel, China, France, Thailand and Malaysia would be participating in the event. The representation of the speakers would be in the ratio of 40 percent from Asian countries, 30 percent from Europe and 30 percent from the West. The conference is slated to cover topics as diverse as: Current opportunities in Asian Biotechnology Asia as a global partnering hub-addressing opportunities in clinical trials, contract research, vaccines and preventive medicines. Bio-entrepreneurship Bio-IT Opportunities in Agri-Biotechnology, focusing on GMOs, Phytoceuticals, Biofuels, plant based medicines. B2B Forum: "The B2B Forum would focus on investment opportunities in the biopharmaceutical industry in India. Venture capitalists, financial institutions and other investors are widely expected to participate in this forum," said Dr A Ashok, deputy secretary and director of biotechnology, industries and commerce department, Government of Andhra Pradesh. He further added that, "The B2B Forum organized by All India Biotech Association-Southern Chapter will be scheduling one-to-one sessions between different participants. Delegations from the US, Germany, Italy, Pakistan, UK, Finland, Switzerland, Sweden, Korea, Malaysia, Thailand and Iran have already confirmed their participation." CEO Conclave: The CEO Conclave is a special industry meet of over 300 distinguished people, coming from diverse backgrounds. BioAsia, promoted by the Andhra Pradesh government as part of the Genome Valley initiative, was launched in 2004. The forum is positioned as the annual global bio business feature in Hyderabad. The event is expected to witness a lot of action, as the Andhra Pradesh government is keen to further support and renew the initiatives of the previous government in the biotech sector. It maybe recalled that the first edition was promoted by the previous government headed by the Telugu Desam Party (TDP) under the leadership of N Chandrababu Naidu. The current Congress-led government came to power winning the state elections in May 2004. The stage is now set to make this event very meaningful and big. "The Andhra Pradesh government decided to promote BioAsia-The Global Bio Business Fourm, as an annual biotech event to give further impetus to its initiatives. BioAsia 2004 was a huge success based on the quality of speakers, delegates and exhibits, business discussions and initiations, quality representation from across the globe and sharing of knowledge that took place during the summit," informed Prof. D Balasubramanian, chairman, Biotech Advisory committee. BioAsia consists of an international conference, a tradeshow, B2B Forum and a CEO conclave. According to the organizers of the event, over 60 exhibitors, 500 conference delegates, 70 internationally acclaimed speakers and 15,000 visitors from across the globe are expected to attend BioAsia 2005. The event is proposed to be hosted at Hotel Viceroy, Hyderabad, and aims at building global alliances and collaborations, showcasing products and services, acting as a platform for companies, government, and network with industry leaders, research scientists and media analysts. There would be additional emphasis on agri biotech. Also the organizers intend to allocate more time for field visits to give an insight into the facilities available for foreign visitors. Another key feature of the event would be the launch of Federation of Asian Biotech Associations (FABA). Dr BS Bajaj, chairman, All India Biotech Association, said, "The leaders of delegation of eight Asian countries who met during BioAsia 2004 had decided to form FABA to create a common platform for development of biotechnology in Asian countries. It would be launched at BioAsia 2005 and a management committee of 25 members would be formed with its secretariat located in Hyderabad."   "The initiatives taken by the government are resilient enough to spur growth and we are driving home the point that India in general and Hyderabad in particular would be the biotech hub of Asia." - Dr A Ashok A biotech policy, the Genome Valley cluster, venture funds, and events like BioAsia are the legacy forwarded to Dr A Ashok, deputy secretary and director of biotechnology, industries and commerce department, Government of Andhra Pradesh. He assumed office in November 2004 and within a short span of two months, he is striving hard to make BioAsia a successful event. He wants to take the legacy further forward. In conversation with CyberMedia News, Dr A Ashok shares the views on the initiatives in store in Andhra Pradesh. What is the AP government's stand on biotech? The new government is equally committed to biotech and is consistently pursuing proactive policies to support and promote biotechnology in the state. A testimony to this is the fact that Andhra Pradesh has bagged the prestigious "BioSpectrum-Bio State of the year" in 2003, the first ever biotech industry award in the country. The government proposes to redraft the biotech policy and introduce positive changes that would enable an investor friendly environment. What is the status of some of the key initiatives? The Department of Biotechnology (DBT) and Government of Andhra Pradesh in association with IICT, which is the technical knowledge partner, are jointly setting up a biotechnology incubation center. This is the India's first biotech incubator being set up with a sanctioned outlay of Rs 20 crore. This center is aimed at promoting start-up companies to scale up their production and to commercialize their products. The design of the incubation center was through in November and the construction work would be taken up. The Institute of Life Sciences, which is to be set up as a Center of Excellence in Genome Valley and the National Animal Resource Facility, which will be set up in partnership with ICMR and NIN, are being allocated 100 acres of land. The government has granted Rs 10 crore for the setting up of the Institute. Towards this, Rs 6 crore has already been sanctioned. Out of this, while a sum of Rs 1 crore is being dispatched, another Rs 5 crore is in the pipeline. For the Agri-Science park, Rs 3 crore has been sanctioned over a five-year-period. The Marine Biotech Park has been set up at Parawada, Visakhapatnam, spread over 218 acres of land. Two firms Biogenus and Celgen have already been allotted the required land. A Marine Biotech Complex is also proposed in the Marine Biotech Park in association with the Andhra University. The complex would focus on marine resources and would work towards developing vaccines to prevent diseases, apart from research on marine foods, nutraceuticals and fisheries. What is the occupancy rate in the Genome Valley? The cluster houses ICICI Knowledge Park, India's first knowledge park in collaboration with research community and industry. A Life Sciences Incubation Center has been set up with an investment of Rs 30 crore with eight labs of which four are exclusively for biotech and the rest for chemistry laboratories. At present, more than 10 laboratories are operating in the park and seven companies have booked 100 percent laboratory space. Another 20,000 sq ft of modular wet laboratory space is in the design stage and is expected to be ready by the mid of 2005. The Shapoorji Pallonji (SP) Biotech Park is a Rs 100-crore project, spread over 400 acres of land. Fourteen companies in the first phase spanning across 140 acres have occupied 75 percent of the space. KCP Biotech has completed the construction, while Vimta Labs has started the construction of its clinical research facility. Biological Evans has taken 50 acres of land for setting up the vaccine manufacturing facility and is asking for an additional 50 acres of space, which we would be sanctioning soon. Shantha Biotech is also in the process of setting up its facility. The SP group is also considering a plan to establish ready-to-occupy R&D laboratories for pharmaceuticals and biotech companies. Sunitha Natti (CNS) in Hyderabad BioAsia 2005 in February The second edition of BioAsia, the global bio business forum, will be held in Hyderabad from February 10-12, 2005. Promoted by the Government of Andhra Pradesh and Genome Valley, Hyderabad, BioAsia 2005 will provide the ideal meeting ground to transact business, build global alliances and collaborations, showcase products/services and network with industry leaders, research scientists and media analysts. BioAsia consists of an international conference, a tradeshow, B2B Forum and a CEO conclave. For more details, contact: exhibition@bioasia.org, conference@bioasia2005.org, b2b@bioasia2005.org. Bangalore BIO 2005 The Department of IT and Biotechnology, Government of Karnataka and Vision Group on Biotechnology will jointly organize Bangalore BIO 2005 from April 22-24, 2005. The core theme of the conference will be 'Bio-technology for billion people.' The three-day conference will be addressed by over 50 speakers from all across the globe. About 700 delegates are expected to attend the conference. For further details, contact: biosec@bangalorebio.com or biodir@bangaloreit.com. 2nd Nutraceutical Summit The 2nd Nutraceutical Summit International Seminar & Expo will be held from February 3-5 at Intercontinental, The Grand, New Delhi. The summit will lay special emphasis on good production, packaging and storage practices. It will showcase capabilities of Indian entrepreneurs in meeting global requirements. For more details, contact: mahinder@MMACTIV.com, ravi@MMACTIV.com or kalindi@MMACTIV.com. Biobusiness 2005 BioBusiness 2005 is the seventh event in the world-renowned BioBusiness series of senior level biotech-pharma partnering meetings. It will be held from January 25-28, 2005 at Geneva, Switzerland. The key attractions include the state-of-the-art one-to-one partnering meetings service. The meeting will also feature an exceptionally senior speaker faculty of 49 business development and licensing thought-leaders. For more details, contact: pives@wbr.co.uk Biotech International Conference 2005 The CHEMTECH Foundation will also conduct Biotech International Conference 2005 from February 10 - 11, 2005. Some of the topics that would be covered include Innovation through Biotech: Mechatronics- Innovative Engineering, Financing Biotech and infrastructure projects: Venture Capital / Benchmarking Infrastructure Facilities and Genomics & Proteomics: Genes and the future of mankind. Drug Discovery & Development Conference The Industrial Pharmacy Division of the IPA and IPA Maharashtra State branch along with the AAPS, FIP, APSTJ and FPTI, will organize a conference on February 11- 12, 2005 in Mumbai. The meet will focus on technology platforms and issues related to early selection and development of candidate drug molecules. Scientists can play a major role in drug discovery research by utilizing their vast skill and expertise in the areas of medicinal chemistry, biochemistry, pharmacology, formulation development and clinical assessment. For further details, contact: ipacentr@mtnl.net.in Biotech India 2005 Biotech India 2005, CII's 2nd International exhibition and conference on Biotechnology will be held from February 9-12 in New Delhi. The event will bring together key players of the industry, researchers and academicians, and relevant government representatives under one umbrella. It will exhibit state-of- the-art technologies and focus on emerging opportunities in areas such as human and animal healthcare, agriculture and industrial use. For more information, contact: g.k.raman@ciionline.org ]]> <![CDATA[Optimism In The Air]]> https://biospectrumindia.com/news/95/5861/optimism-in-the-air.html https://biospectrumindia.com/news/95/5861/optimism-in-the-air.html Thu, 06 Jan 2005 16:23:00 +0530 A remarkable year has gone by. Every one looks forward to 2005 with optimism. Mainly because of the events of the past 12 months which have given a sense of hope to the fledgling biotech community. The biggest gain of 2004 is that the word "biotechnology" now has a buzz around it. Gradually it is becoming part of the vocabulary of the nation's policy makers. That is why 2005 is such good year to look forward to. One of the most vociferous demand of the biotech sector in the last few years was the need for a simple, efficient and predictable regulatory environment. We are closer to getting there, thanks to the recommendations of the M S Swaminathan Task Force on Agribio and R A Mashelkar Task Force Report on a new regulatory structure for recombinant DNA products. Two hardworking policy makers, Dr M K Bhan and Minister Kabil Sibal are leaving no stone unturned to ensure that the hard work put in by the task forces provide long term benefits and lead to a booming biotech sector. In the nick of time, through an executive order by the President (pending passage of the legislation by Parliament), India's knowledge sector has joined the global mainstream in recognizing innovations. There are many harsh criticisms about this route. Yet the government has demonstrated that full recognition to Intellectual Property Rights (IPRs) will be the cornerstone of India's march into the emerging global economy dominated by the knowledge sectors. Unlike their pharma counterparts, biotech leaders have been clamoring for full scale support to IPRs, the edifice on which the modern industry is built. Their wishes have been granted by India's compliance with the global IPR regime. And India has certainly used most the avenues available for creative interpretation of the safeguards available to protect the generics-based domestic pharma sector. The biotech sector has moved to the next stage on the funding issue. It is no longer a litany of complaints against potential investors. ABLE has taken the first step to engage the financial community in a dialogue about the industry's real requirements and a series of follow-ups are expected in the coming months to meet the funding needs of the industry. The country's largest bank, State Bank of India, has started to take active interest in the sector and that is certainly a good news. As biotechnology joins the mainstream economy in the coming years, the biotech ecosystem is bound to enlarge in size. The much awaited National Biotechnology Policy likely to be unveiled in early 2005 is likely to include a series of steps to create awareness among the new stakeholders such as rural and urban communities, legal system, law enforcement machinery and also the students community which will provide the talent pool for growth. With so many good things going, there could have been a big party. But the monstrous tsunami waves that lashed Asia have added a sour note. In far away, people of UK are contributing at the rate of one million pounds an hour for tsunami relief. As the world joins us in this hour of sorrow, we too should do our bit in every possible way. William Faulkner, in his Nobel Prize acceptance speech, said: "I believe that man will not merely endure: he will prevail. He is immortal, not because he alone among creatures has an inexhaustible voice, but because he has a soul, a spirit capable of compassion and sacrifice and endurance." Let us also make sure that Faulkner's trust in human race is vindicated as we look forward optimistically to a promising new year.   sureshn@cybermedia.co.in   ]]> <![CDATA[Management of Intellectual PropertyÂ - The Driver of Biotechnology Industry]]> https://biospectrumindia.com/news/95/3366/management-of-intellectual-property-the-driver-of-biotechnology-industry.html https://biospectrumindia.com/news/95/3366/management-of-intellectual-property-the-driver-of-biotechnology-industry.html Thu, 06 Jan 2005 16:20:00 +0530 (Continued from December 2004 issue) Kumud Sampath Inventor designation on a patent application Inventor identification is very challenging and a sensitive issue to a project manager in a biotechnology company. Unlike authorship on research papers, not all members of a research team can be considered as inventors. Inventors by definition are those members of a research team who conceived the complete and operative aspects of the invention. Of course the invention has to be worked through appropriate experimental examples, otherwise called "reduction to practice" which can be performed by anyone trained in the scientific disciplines. Therefore, those experimenters cannot be designated as inventors. Sometimes, although rare, reduction to practice may require extraordinary skills and in such cases contributions made by the experimenter may qualify for inventorship.   Ownership of a patent Inventorship provides the basis for determining the ownership. Most often a signed employment agreement obligates the inventor to assign the rights of the invention to the employer. Thus, for biotechnology enterprises it is very important that legally well drafted employment agreements are executed by all employees, which require that the employer be assigned of all rights to the invention conceived and reduced to practice in connection with the employment. Intellectual property portfolio strategy The development of a IPR portfolio strategy varies from the needs of a start-up biotech company which is centred around a scientific concept or a technology platform to a biopharmaceutical company which produces or markets biopharmaceutical products or an agricultural biotech company which produces or markets products such as pest resistant plant seeds or strains or biopesticides and others. Nevertheless, a well thought out IPR strategy is essential in all cases. The term of a patent is 20 years, which starts from the date of filing. Thus, the timing assumes importance in terms of the duration for marketing a product. If the patent is filed too early during R&D, the window of opportunity to market the product as well as the size of the market will be smaller. Granting patent rights to inventors is a legal provision created by each nation according to its constitution. Therefore, patent applications have to be filed in countries where the applicant seeks the protection. However, several nations including India have entered into a treaty called Patent Cooperation Treaty (PCT), which is administered by the World Intellectual Property Organization (WIPO). Thus, a single PCT filing establishes a common priority date for the invention in all the countries, which are signatories to the treaty. A PCT application can be filed at any of the Regional Patent Offices in India. It must be remembered that the PCT prosecution does not result in the issuance of any national patents, but it provides a cost effective means of establishing the priority date and also buys in 18 months of time from the date of filing to determine the commercial value of the invention. The decision on choosing, in which countries the patent application designated in the PCT application should be prosecuted, rests with the biotech company and its commercial strategy or business plan. The PCT route offers several advantages. One can obtain a patentability search and initial examination on a single application, which limits the costs for examination in each country, but the disadvantage is that a single examiner rules on the patentability. Alternatively, by filing a PCT application and choosing an option to file for Intellectual Property Protection in selected countries, one can defer for up to eighteen months for examination thus delaying the expenses involved in prosecuting the patent application. Evaluation of inventions in biotechnology The monetary worth of inventions is the prime consideration for bioentrepreneurs to seek investments from banks and venture firms. Although at the moment, investing organizations and banking community in India are not accepting patents as collateral, it is bound to come into vogue soon. There are many approaches to put a price tag on biotechnological inventions such as the cost of invention, the market and income from licensing. A novel method of risk adjusted net present value has been described recently which helps in arriving at a fair value for an invention (J.J.Stewart, P.N.Allison & R.S.Johnson, Nature Biotechnology 19 (2001) 5-9). However, it is important to realize that intellectual property (IP) has a value cycle, which has three distinct stages. The first stage is the growth phase during which technology and market development takes place. As the technology matures and the market uncertainty is lowered, the value of IP increases. The second stage is when the value of IP reaches a peak and the revenue generation reaches a maximum and the third stage is the period when the "net present value" drops due to competing products entering the market. Therefore, the evaluation of IP has to be made carefully by allocating weightings to a number of factors such as duration of IP protection, market forces and the size of the stage II window of opportunity. Licensing of biotechnological inventions A successful licensing strategy depends on the company's (institution's) business objectives. Different inventions require different licensing strategies. Small biotech start-up companies or university departments or public research institutions usually have technology platform type of inventions such as scientific tools or very early stage "proof of principle" type of inventions with potential wide applications. These are licensed on a nonexclusive basis whereas inventions, which require significant investments and/or resources, are generally licensed on an exclusive basis. The concept of "freedom to operate" agreement among pharmaceutical companies is becoming a common practice, which includes a non-exclusive cross- licensing provision. By this agreement, the companies agree to use each other's intellectual property for research and development of some defined number of products for a specified time and financial consideration. Such agreements minimize the risk of infringement of each other's intellectual property and save considerable resources. There are large numbers of patents on enabling technologies, which are owned both by private and public institutions world over. These include mainly tools of biotechnological research, such as expression vectors, selectable markers on plasmids, synthetic or constitutive promoters, transformation methodologies, assay methods, genes and gene products, etc. Prof. David Zilberman and colleagues at the University of California Berkeley (Calif. USA) have proposed a novel concept of a form of collective rights organization (Clearinghouse), whose functions include, identification and extent of availability of technologies for licensing, facilitating an interaction between patent owners and potential users and assisting in contractual licensing agreements. Clearinghouse concept of Prof. Zilberman is a viable strategy for Indian biotechnology research based industry The governance of IPRs Intellectual Properties are essentially intangible resources and assets not only for business enterprises but also to the country, which influence economic growth. The governance of Intellectual Property Rights therefore, assumes a crucial role in policy making. The adoption of IPR regime inevitably brings into fore claims, conflicts and disputes particularly in the fiercely competitive knowledge-based industries. Thus the implementation of IPR laws through an efficient legal system assumes greater importance in the governance of the IPR regime since benefits of the IPR system can be realized only if there is an effective enforcement process in place. Although the Indian Legal system is known for fair dispensation of the law, it has the reputation of being extremely slow and riddled with complex procedures. There is an urgent need to streamline the process and establish new institutions to handle IPR litigations. However litigations in India and elsewhere are expensive in addition to being time-consuming. Hence, many business firms are opting for alternative dispute resolution (ADR) processes.The World Intellectual Property Organization (WIPO) Arbitration and Mediation Centre located in Geneva (Switzerland) offers dispute resolution services particularly for cross-border IPR disputes, which include both contractual disputes (patent licenses) and non-contractual disputes (patent infringement). IPR licensing practices sometimes introduce conflicts related to monopoly and national interests, such as unilateral refusal to license a patent or sell items covered by such a patent. Although there are many potential benefits to cross licensing, concerns may arise with agreements, which are intentionally designed to facilitate product-market collusion. Adequate safeguards are to be built into laws related to monopoly and restrictive trade practices (MRTP). Opportunities knocking on our doors There is little doubt that India is embarking on a knowledge-based economy. There is also an unprecedented hope that biotechnology will provide an opportunity to garner a significant part of the world market for Indian biotech products and services. Although the hope is well founded because India has trained human resources and scientific expertise but at the moment India is ill prepared to meet the challenges to realize the dream. Educational systems have to be revised to include innovation culture by removing rigid barriers to widen opportunities. There has to be a war front effort to mobilize resources and streamline operations to drive the industry to compete in the world market. Indian government must perceive that Intellectual Property Rights are essential for the rapid growth of the biotech industry. Subsequent to the introduction of the patent regime, Indian Patent offices will receive a large number of patent applications from within the country and outside, which will provide a significant revenue source. However, Indian patent offices lack both human resources and expertise in examining biotechnological inventions and the claims made. Human resource mobilization to process biomedical, agro-biotech and other biological inventions is of immediate need. Thus, there exists an enormous opportunity for students engaged in biological, chemical and medical sciences in a variety of functions both in public and private sectors, such as in technology development, technical writing for IP protection, mining data for innovation, legal drafting of patent applications, patent search and examination of claims, as well as in litigation, arbitration and mediation. Another area where Indian biotech entrepreneur could greatly benefit from is, private funding of research. Although there is considerable venture-funding activity in India, there is very little investment into biotechnology research leading to novel products. Bankers and investment managers allude to ignorance of domain knowledge. There is an urgent need to provide basic courses in biotechnology and business opportunities to bankers, investment managers, SEBI and other investing agencies. It is hoped that with the introduction of laws to protect Intellectual property rights, India will usher-in the culture of innovation and propel the Indian economy to achieve the goal of transforming India to a developed country by 2020. Kumud Sampath is Head of Operations at AstraZeneca India. She is a member of the Vision Group for Biotechnology in Karnataka State and member of the Executive Council of ABLE. The views expressed in this article are her own and do not necessarily reflect the policies of the Vision Group, ABLE or her employer, AstraZeneca. ]]> <![CDATA[Management of Intellectual PropertyÂ ]]> https://biospectrumindia.com/news/95/1160/management-of-intellectual-property-.html https://biospectrumindia.com/news/95/1160/management-of-intellectual-property-.html Thu, 06 Jan 2005 16:18:00 +0530 Management of Intellectual Property  The Driver of Biotechnology Industry (Continued from December 2004 issue) Kumud Sampath Inventor designation on a patent application Inventor identification is very challenging and a sensitive issue to a project manager in a biotechnology company. Unlike authorship on research papers, not all members of a research team can be considered as inventors. Inventors by definition are those members of a research team who conceived the complete and operative aspects of the invention. Of course the invention has to be worked through appropriate experimental examples, otherwise called "reduction to practice" which can be performed by anyone trained in the scientific disciplines. Therefore, those experimenters cannot be designated as inventors. Sometimes, although rare, reduction to practice may require extraordinary skills and in such cases contributions made by the experimenter may qualify for inventorship.   Ownership of a patent Inventorship provides the basis for determining the ownership. Most often a signed employment agreement obligates the inventor to assign the rights of the invention to the employer. Thus, for biotechnology enterprises it is very important that legally well drafted employment agreements are executed by all employees, which require that the employer be assigned of all rights to the invention conceived and reduced to practice in connection with the employment. Intellectual property portfolio strategy The development of a IPR portfolio strategy varies from the needs of a start-up biotech company which is centred around a scientific concept or a technology platform to a biopharmaceutical company which produces or markets biopharmaceutical products or an agricultural biotech company which produces or markets products such as pest resistant plant seeds or strains or biopesticides and others. Nevertheless, a well thought out IPR strategy is essential in all cases. The term of a patent is 20 years, which starts from the date of filing. Thus, the timing assumes importance in terms of the duration for marketing a product. If the patent is filed too early during R&D, the window of opportunity to market the product as well as the size of the market will be smaller. Granting patent rights to inventors is a legal provision created by each nation according to its constitution. Therefore, patent applications have to be filed in countries where the applicant seeks the protection. However, several nations including India have entered into a treaty called Patent Cooperation Treaty (PCT), which is administered by the World Intellectual Property Organization (WIPO). Thus, a single PCT filing establishes a common priority date for the invention in all the countries, which are signatories to the treaty. A PCT application can be filed at any of the Regional Patent Offices in India. It must be remembered that the PCT prosecution does not result in the issuance of any national patents, but it provides a cost effective means of establishing the priority date and also buys in 18 months of time from the date of filing to determine the commercial value of the invention. The decision on choosing, in which countries the patent application designated in the PCT application should be prosecuted, rests with the biotech company and its commercial strategy or business plan. The PCT route offers several advantages. One can obtain a patentability search and initial examination on a single application, which limits the costs for examination in each country, but the disadvantage is that a single examiner rules on the patentability. Alternatively, by filing a PCT application and choosing an option to file for Intellectual Property Protection in selected countries, one can defer for up to eighteen months for examination thus delaying the expenses involved in prosecuting the patent application. Evaluation of inventions in biotechnology The monetary worth of inventions is the prime consideration for bioentrepreneurs to seek investments from banks and venture firms. Although at the moment, investing organizations and banking community in India are not accepting patents as collateral, it is bound to come into vogue soon. There are many approaches to put a price tag on biotechnological inventions such as the cost of invention, the market and income from licensing. A novel method of risk adjusted net present value has been described recently which helps in arriving at a fair value for an invention (J.J.Stewart, P.N.Allison & R.S.Johnson, Nature Biotechnology 19 (2001) 5-9). However, it is important to realize that intellectual property (IP) has a value cycle, which has three distinct stages. The first stage is the growth phase during which technology and market development takes place. As the technology matures and the market uncertainty is lowered, the value of IP increases. The second stage is when the value of IP reaches a peak and the revenue generation reaches a maximum and the third stage is the period when the "net present value" drops due to competing products entering the market. Therefore, the evaluation of IP has to be made carefully by allocating weightings to a number of factors such as duration of IP protection, market forces and the size of the stage II window of opportunity. Licensing of biotechnological inventions A successful licensing strategy depends on the company's (institution's) business objectives. Different inventions require different licensing strategies. Small biotech start-up companies or university departments or public research institutions usually have technology platform type of inventions such as scientific tools or very early stage "proof of principle" type of inventions with potential wide applications. These are licensed on a nonexclusive basis whereas inventions, which require significant investments and/or resources, are generally licensed on an exclusive basis. The concept of "freedom to operate" agreement among pharmaceutical companies is becoming a common practice, which includes a non-exclusive cross- licensing provision. By this agreement, the companies agree to use each other's intellectual property for research and development of some defined number of products for a specified time and financial consideration. Such agreements minimize the risk of infringement of each other's intellectual property and save considerable resources. There are large numbers of patents on enabling technologies, which are owned both by private and public institutions world over. These include mainly tools of biotechnological research, such as expression vectors, selectable markers on plasmids, synthetic or constitutive promoters, transformation methodologies, assay methods, genes and gene products, etc. Prof. David Zilberman and colleagues at the University of California Berkeley (Calif. USA) have proposed a novel concept of a form of collective rights organization (Clearinghouse), whose functions include, identification and extent of availability of technologies for licensing, facilitating an interaction between patent owners and potential users and assisting in contractual licensing agreements. Clearinghouse concept of Prof. Zilberman is a viable strategy for Indian biotechnology research based industry The governance of IPRs Intellectual Properties are essentially intangible resources and assets not only for business enterprises but also to the country, which influence economic growth. The governance of Intellectual Property Rights therefore, assumes a crucial role in policy making. The adoption of IPR regime inevitably brings into fore claims, conflicts and disputes particularly in the fiercely competitive knowledge-based industries. Thus the implementation of IPR laws through an efficient legal system assumes greater importance in the governance of the IPR regime since benefits of the IPR system can be realized only if there is an effective enforcement process in place. Although the Indian Legal system is known for fair dispensation of the law, it has the reputation of being extremely slow and riddled with complex procedures. There is an urgent need to streamline the process and establish new institutions to handle IPR litigations. However litigations in India and elsewhere are expensive in addition to being time-consuming. Hence, many business firms are opting for alternative dispute resolution (ADR) processes.The World Intellectual Property Organization (WIPO) Arbitration and Mediation Centre located in Geneva (Switzerland) offers dispute resolution services particularly for cross-border IPR disputes, which include both contractual disputes (patent licenses) and non-contractual disputes (patent infringement). IPR licensing practices sometimes introduce conflicts related to monopoly and national interests, such as unilateral refusal to license a patent or sell items covered by such a patent. Although there are many potential benefits to cross licensing, concerns may arise with agreements, which are intentionally designed to facilitate product-market collusion. Adequate safeguards are to be built into laws related to monopoly and restrictive trade practices (MRTP). Opportunities knocking on our doors There is little doubt that India is embarking on a knowledge-based economy. There is also an unprecedented hope that biotechnology will provide an opportunity to garner a significant part of the world market for Indian biotech products and services. Although the hope is well founded because India has trained human resources and scientific expertise but at the moment India is ill prepared to meet the challenges to realize the dream. Educational systems have to be revised to include innovation culture by removing rigid barriers to widen opportunities. There has to be a war front effort to mobilize resources and streamline operations to drive the industry to compete in the world market. Indian government must perceive that Intellectual Property Rights are essential for the rapid growth of the biotech industry. Subsequent to the introduction of the patent regime, Indian Patent offices will receive a large number of patent applications from within the country and outside, which will provide a significant revenue source. However, Indian patent offices lack both human resources and expertise in examining biotechnological inventions and the claims made. Human resource mobilization to process biomedical, agro-biotech and other biological inventions is of immediate need. Thus, there exists an enormous opportunity for students engaged in biological, chemical and medical sciences in a variety of functions both in public and private sectors, such as in technology development, technical writing for IP protection, mining data for innovation, legal drafting of patent applications, patent search and examination of claims, as well as in litigation, arbitration and mediation. Another area where Indian biotech entrepreneur could greatly benefit from is, private funding of research. Although there is considerable venture-funding activity in India, there is very little investment into biotechnology research leading to novel products. Bankers and investment managers allude to ignorance of domain knowledge. There is an urgent need to provide basic courses in biotechnology and business opportunities to bankers, investment managers, SEBI and other investing agencies. It is hoped that with the introduction of laws to protect Intellectual property rights, India will usher-in the culture of innovation and propel the Indian economy to achieve the goal of transforming India to a developed country by 2020. Kumud Sampath is Head of Operations at AstraZeneca India. She is a member of the Vision Group for Biotechnology in Karnataka State and member of the Executive Council of ABLE. The views expressed in this article are her own and do not necessarily reflect the policies of the Vision Group, ABLE or her employer, AstraZeneca. ]]> <![CDATA[Trail Blazing Trials]]> https://biospectrumindia.com/news/95/7733/trail-blazing-trials.html https://biospectrumindia.com/news/95/7733/trail-blazing-trials.html Thu, 06 Jan 2005 16:11:00 +0530 Clinical development of a new drug comprises about two thirds of the total development costs. With focus on cost containment across the global pharma companies, speedier, low cost and reliable clinical trials are the order of the day. And India is emerging as a natural choice for contract clinical research services. Projected growth of the Indian clinical research industry Resources Clinical research market GCP Studies GCP trained investigators Subjects required Clinical research professionals Source: McKinsey Report 2010 $1.5 Billion 1,500-2,000 10,000-15,000 2,00,000-3,00,000 50,000 Clinical trial is the most significant direct cost factor related to drug discovery and development. On an average it costs $282 million and takes about seven years to complete. According to industry estimates, the cost of phase I trial is 50 percent and phase II, 60 percent lower in India. Moreover, cost saving alone is not the only obvious advantage. The ability to find and qualify the right patient pool is an appealing factor for Indian trials as the country offers genetically and culturally diverse population where treatment-naive patients are willing to participate. According to Kiran Mazumdar-Shaw, CMD, Biocon and president, ABLE, "The Indian advantage in clinical development is clearly the speed of patient enrolment and thereby shorter timelines for clinical trials". According to Mc Kinsey report, the clinical research industry will witness a business of Rs 10,000 crore creating a demand of 50,000 professionals in the next five years. Analysts project that by 2008 upto 30 percent of global clinical trials will take place outside US and Western Europe and India would emerge a favorable destination. Widening operations of CROs The number of companies participating in clinical research and trials is going up. Some big Indian pharmaceutical companies like Wockhardt, Lupin and Sun Pharma are working on new chemical entities and have established their own clinical research units to conduct trials for their new molecules. Referral labs such as Dr Lal's lab, Metropolis health services and SRL Ranbaxy are offering clinical trial services. IT companies like Cognizant, Eassar, HCL, IBM, Infosys and TCS are keen on making investments on data management. Today there are over 25 CROs working in India, with many pharma companies having their own clinical research units conducting clinical trials in over 80 government and private hospitals. Clinical trials are conducted by the clinical research outfits of multinationals like Eli Lilly, Pfizer, Novartis and Aventis and some in-house clinical research is being done by Indian majors. For instance, Eli Lilly India is presently conducting 17 global and local trials in 65 locations in the country. There are many independent Clinical Research Organizations (CRO) in the fray too, which are consolidating their base and expanding operations. Mumbai-based SIRO Clinpharm, a contract CRO, conducts clinical trials in various therapeutic segments and offers a spectrum of clinical development services. Ahmedabad-based Synchron Research offers services in phase I, high through put screening for rapid PK analysis, qualitative and quantitative medical imaging and in silico drug metabolism studies. It has conducted over 200 bioavailablity studies. Bangalore-based Lotus Labs has completed more than 450 bio studies and is conducting several phase III trials. It has set up facilities in Bangalore and Chennai for conducting clinical research and has recently tied up with St John's National Academy of Health Sciences, Bangalore for conducting Phase I trials. Mumbai-based ClinInvest Research focuses on all phases of clinical trials mainly in the areas of oncology, neuro-psychiatry, cardiology and diabetes drugs. Clingene International, a Biocon subsidiary, concentrates on Phase I-IV clinical trials, bio analytical, bio statistical and data management services to its clients. The company recently inaugurated a human pharmacology unit at Sagar Apollo Hospital, Bangalore. Quintiles Spectral (India), a subsidiary of Quintiles Transnational, a BioSpectrum Top 20 company and the market leader in the clinical services segment, conducts studies in oncology, psychiatry, neurology, anti-infectives, etc. "Clinical research is a human resource intensive enterprise" Pfizer India, an affiliate of Pfizer Inc-a global research based health care company, has contributed to the development of clinical research and biometrics in India, being among the first multinational to establish clinical research operations in the country. Dr Chandrashekhar N Potkar, head, Clinical Trials function for Pfizer India, spoke about the opportunities in this segment. What are the current trends in the clinical trials segment? What kind of people does this sector attract? More and more pharma companies/clinical research organizations/site management organizations are entering the clinical research industry in India. There is clearly a high potential for clinical trial segment and clinical research is a rapidly growing industry. Basically, clinical research is a human resource intensive enterprise. Each step in the process of planning and conducting a clinical trial requires appropriately and often highly qualified individuals. Some of the most knowledge intensive parts of the process relate to planning a clinical research program and designing individual clinical studies within the program - activities that require knowledge of the therapeutic area, clinical expertise, and research experience. What are the job categories at Pfizer? What are the skill sets required and the future growth prospects? Presently we have a strong team of about 41 people who work as clinical research associates (CRAs), medical advisors, clinical study managers, manager-clinops. We take in candidates with bachelor/masters in science/pharmacy. For CRAs we do recruit fresh candidates though, prior clinical research experience helps. Pfizer offers competitive salaries by industry standards and one can charter an excellent career path with us with many training opportunities and an inbuilt flexibility in working. How can the quality of human resources be developed/improved for this segment? Clinical research as a discipline must be incorporated for pharmacy/science and medical students. Also, it must be incorporated as a subject at the postgraduate level, as well. In this direction, we have partnered with Academy for Clinical Excellence (based at Bombay College of Pharmacy) to offer certificate as well as diploma course in clinical research.   Competency requirement The CRO industry is a major employer of medical and scientific staff and hence the demand for qualified personnel is on the increase. "Clinical trial is a very data and quality intensive work and may involve high percentage of travel. The scope of any error is very limited and involves high degree of ethics both personal and professional," commented Rajiv Gulati, managing director and chairman, Eli Lilly and Company (India). The segment requires the services of a diverse range of specialists like medical professionals with specialization in internal medicine and pharmacology, nurses, phlebotomists, quality control and quality assurance personnel, data entry personnel, pharmacokinetic specialists, bio statisticians, analytical chemists, laboratory technicians, medical writing group, diagnostic technicians, etc. "From a qualifications perspective we look for PhDs, post doctorates, medical doctors, post graduates in the fields of organic chemistry, molecular biology, micro biology, biotechnology, pathology, biochemistry, pharmacology etc," said Dr Nirupa Bareja, group head (HR), Biocon India. "A potential candidate is judged on the basis of merit, qualifications, motivation, team spirit, passion etc. We look for traits that will help the organization as well as the individual reach their goals," she added. Most of the CROs recruit both fresh graduates as well as personnel with experience depending on the job profile and requirements. But since the field is nascent, most of the companies do not insist on prior experience, though it does provide a selection edge. An ability to reach out to the target audience is also accorded top priority by many companies. "A potential candidate will have an edge if he has experience, but more than that he needs to have good communication skills," sums up Sampath Kumar, CEO, Sristek Consulting, a Hyderabad-based CRO. The bottomline is clearly defined by Raman Akella, head administration, Shantha Biotechnics, Hyderabad, "In the contract industry, the people should be highly skilled and versatile to take up different projects and execute them at low cost in order to be competitive and effective". "The quality of our data is comparable to that from developed countries" Quintiles India, a BioSpectrum Top 20 company, and a leader in the clinical research segment in the country has the experience in working on over 90 clinical studies involving more than 600 sites and 13,000 patients. Dr Narges Mahaluxmivala, President, Clinical Development Services, Quintiles Research India elaborates about the future of India in clinical research. Is India emerging as a new destination for clinical trials? Clinical research in India is at a relatively nascent stage, but the potential for growth is enormous in all aspects. Clinical trials in Phases 2 and 3 and some in Phase 1 and data management are already being conducted in India by us to internationally accepted standards viz. ICH GCP. In-house and sponsor audits have demonstrated beyond doubt that the quality of data is comparable to that obtained from developed countries and that all other necessary parameters including patient rights are observed. Regulatory authorities in the US and in Europe are accepting data which have a substantial proportion from India and three trials conducted by us solely in India, have been accepted by the US FDA as part of a larger program for each indication respectively and the molecules of two of them have been approved by that body. With the improvement in connectivity and in telecommunications, web-based trials where data are captured electronically have been successfully implemented and data management of these trials is ongoing. Data entry and management of clinical trial data, both of studies in Phases 1, 2 and 3 and in Phase 4 have already begun and indications of opportunities for growth are tremendous. India's lower infrastructure costs and the rapidity of recruitment, which compresses timelines, offer a favorable cost benefit to clients. How can a potential candidate have an edge in the selection process? All persons in clinical operations require a graduate or postgraduate qualification in a science subject or a medical qualification since our staff comprises project assistants/associates, clinical research associates, clinical team leaders and project managers. In addition, there are medical monitors, quality assurance personnel, drug safety and regulatory personnel and clinical trial supplies management personnel. Specifically for data management, IT-related and experience in data management would help in addition to the basic qualification. At Quintiles we require the services of data entry assistants, clinical data coordinators, clinical data specialists, database programmers and group managers. For all these functions though prior experience is not a must but is definitely preferable.   Professional training in clinical research Till recently there was a dearth of structured formal training courses focusing on clinical research and trials. It was difficult to get trained manpower through tailor-made courses that are recognized and accepted by the industry. As Dr Shiv Prakash, MD, Synchron, commented, "There are many investigators who are not GCP trained but are highly inclined to get involved in conducting clinical trials and such enthusiastic investigators, if trained for GCP will create an ocean of good investigators for almost all indications." Now this gap is being filled. For instance, the Manipal University, in association with the Purdue University, offers a one-year diploma in cGMP training. The Institute of Clinical Research (India) offers a range of tailor-made courses in the clinical research segment at its Dehradun and Mumbai campus. Lotus Labs plans to start formal GCP / GLP training programs soon and is in the process of setting up training centers. Pfizer has partnered with the Mumbai-based Academy for Clinical Excellence to offer certificate as well as diploma course in clinical research. Growth Opportunities The segment offers rapid growth prospects once skills are acquired to conduct and manage clinical trials as per global requirements. Employees are given every opportunity to excel, challenge boundaries, and go beyond expectations. With performance as the key driver, employees are given attractive emoluments, much above the average salaries in the medical sector or pharma industry, with liberal incentives. On an average salaries vary from Rs 8,000 per month for an entry level to anywhere between Rs 40,000-60,000 per month for middle managerial positions. Rolly Dureha   ]]> <![CDATA[BioSpectrum AWARDS NITE]]> https://biospectrumindia.com/news/95/2061/biospectrum-awards-nite.html https://biospectrumindia.com/news/95/2061/biospectrum-awards-nite.html Thu, 06 Jan 2005 15:56:00 +0530 On December 10,2004, BioSpectrum hosted the awards ceremony to present the Awards to recognize the contribution of the people, products and companies in the biotech industry to this sector in India. A report. Inauguration of BioSpectrum Awards Nite. Dr MK Bhan, secretary, DBT, releasing BioSpectrum's India's Top 20 BT Schools supplement. Dr MK Bhan addressing the gathering. Panel discussion on the National Biotech policy in progress. Kiran Mazumdar-Shaw, CMD, Biocon Ltd making a point during the panel discussion. N Suresh, Editor, BioSpectrum, giving the vote of thanks. The BioSpectrum Awards Nite in Bangalore was kicked off with a panel discussion on the proposed National Biotech Policy and followed by the release of the first ever survey of India's top 20 BT schools and the Awards presentation ceremony. The function saw one of the largest gatherings in the biotech sector. Over 320 key officials from the industry, government and academic institutions attended the function. Dr MK Bhan, secretary, Department of Biotechnology (DBT), was the chief guest for the function. Release of India's Top 20 BT Schools Supplement Releasing BioSpectrum's special issue on India's top 20 biotech schools, the DBT secretary said it was time to celebrate the institutes and institutions that had done yeoman service in the field of biotechnology. "They have contributed in their unique ways a tremendous passion for excellence. I am going through a phase of learning trying to absorb how science could be used to create an industry, a dynamic society, to create wealth and to address major social concerns. Our ability to elevate and commercialize is way below our potential. There is a need for institutional reengineering and we need to evolve new kinds of mechanism by which we can be productive," he pointed out. Stating that there was also a major need to change the working conditions of scientists in the country, he observed, "we are going to be extremely short of grey area of young scientific manpower and this may dawn on us so suddenly that we may be unprepared for it. Another important aspect is the standardization and quality control of everything that comes in the space of biotechnology and in the spectrum of the society. We need more human resource of much better quality. Therefore the whole range of issues on the working conditions of scientists has to be looked into." Commenting on the progress of science in the country, Dr Bhan noted, "We need to remove impediments to expedite the cycle of development. The user community in India does not believe that Indian science can deliver for them." "The more demonstrable success we have, the more the belief will grow and more ideas will flow. The scientific workforce should be engaged in the right kind of priorities," he felt. Earlier, Ravi Sangal, president, CyberMedia Research, spoke on the research and the methodology adopted to rank biotechnology institutes on measurable and quantifiable data, which was collected from institutes directly using a structured questionnaire on different parameters such as faculty, infrastructure, industry interaction and placement. "Each of the parameters was further weighed as per weights provided by experts to arrive at the total score of an institute and the institutes were then ranked as per this score on a overall basis," he explained. BioSpectrum Awards The Awards Presentation ceremony commenced with Pradeep Gupta, managing director of CyberMedia and publisher of BioSpectrum, explaining how the BioSpectrum Awards had evolved and noted that CyberMedia had been holding various such awards nites and "through this, we recognize all the individuals who have made a difference in the lives of people." Throwing light on the Jury deliberations for selection of the BioSpectrum awardees, Kiran Mazumdar-Shaw, who was the chairman of the Jury, said, "We applied every one of the criteria for selecting the awardees in terms of pioneering spirit, excellence, their commitment to the sector and the difference that they have made in raising the profile of the biotech sector not just in this country but, in many cases globally. All these awardees have been very outstanding personalities." The other members of the Jury to select the awards included KV Balasubramaniam, managing director, Indian Immunologicals, Prof . K VijayRaghavan, director, National Center for Biological Sciences, Aluri Srinivasa Rao, director, investments, ICICI Venture Funds, Mumbai, Pradeep Gupta, managing director of CyberMedia and publisher of BioSpectrum, and E Abraham Mathew, chief editor of BioSpectrum. Listing out the achievements of the awardees, Kiran Mazumdar-Shaw said, "The awardee for Life Time Achievement is somebody who has been the founder-architect of the biotech sector in India. Dr (Mrs) Manju Sharma has built this biotech sector with a lot of belief, faith and determination. She has inherited a sector that was very nascent, tumbling and that was almost forsaken in terms of every possible assistance but yet she very single-handedly raised the  Kiran Mazumdar-Shaw, CMD, Biocon Ltd presenting the Life Time Achievement Award to Dr Manju Sharma, former secretary, DBT. DBT Secretary Dr M K Bhan presenting the Person of the Year Award to Dr Cyrus S Poonawalla, chairman, Serum Institute of India. Aseem Chauhan, chairman, Amity Institute of Biotechnology, giving away the Entrepreneur of the Year Award to Dr KK Narayanan, managing director, Metahelix. Dr BV Ravikumar, managing director, XCyton Diagnostics Ltd, receiving the Produt of the Year Award from Uttara Das Gupta, general manager, State Bank of India. resources to address various issues. It is Dr Sharma who has speared the way for private-public partnership and she always has been very receptive to new ideas and suggestions. She was very instrumental in creating the Mashelkar Committee Task Force and the M S Swaminathan Task Force. She has been equally instrumental in raising various issues at the ministerial levels in terms of obtaining support. She also has been instrumental in creating many biotech parks and the awareness of biotechnology opportunities within the country." On the choice of the Person of the Year, Kiran Mazumdar-Shaw said that it was a very easy one. "Dr Cyrus S Poonawalla clearly stood for all the qualities that it takes to be a leader. With his very pioneering spirit, he has built a world-class institution and put India on the vaccine map of the world. Today it is very clearly recognized that India is one of the leading vaccine producers of the world, thanks to the Serum Institute of India." The Entrepreneur of the Year awardee was Dr KK Narayanan. "Dr Narayanan and Metahelix have really done an outstanding job in terms of participating in an integrated way and becoming a very important part of the biotech sector. He has taken a lot of initiatives. He is one person who has never shied away from this and has always been willing to participate and deliberate on very key issues in biotechnology," she announced. On the Product of the Year, she pointed out, "We put Dr BV Ravikumar's product on the list because we felt that he was an unsung hero-a scientist who was determined to take to the market something that he had developed on the lab bench. It was his sheer daring and persistence that got him to where he is today. The product that we recognized in terms of its innovative development was the Japanese Encephalitis diagnostic kit that XCyton Diagnostics Ltd has developed," she informed. This was followed by the presentation ceremony of the BioSpectrum Awards 2004. On receiving the Life Time Achievement award from Kiran Mazumdar-Shaw, Dr Manju Sharma, former secretary, DBT said, "Biotechnology has been discussed in this country for many years now. It started in the labs of CSIR, a few institutions of DST, and some universities and of course a very major effort by the IISc, Bangalore. But these were all individual efforts. In order to put biotechnology in the national context, the DBT which was started in 1986, started many major initiatives. I have just been a facilitator. Whatever has been done in biotechnology today and where we stand, I think it is just because of the right approach. There has been a saying that biotechnology is probably the greatest intellectual enterprise of the human kind. India is very rich in biodiversity, which is the feeder stock of biotechnology. Our country is one among the 25 hotspots in the world. Today if we have to use the feeder stock in a manner in which it has to be used in humankind, I think we are moving in the right direction. Industry has come into this field in a very big way in the last five to six years." Talking about the regulatory process, she said, "We have just started the exercise of simplifying the regulatory procedure. It is really not so much of a new structure one is talking of or entirely new institutional framework. It is just putting the whole thing together what exists and speeding up the process. To my mind, the success of everything depends not so much on discussion but actual action and fast pace." Accepting the Person of the Year award from Dr M K Bhan, Dr Cyrus S Poonawalla, chairman, Serum Institute of India, was reminiscent of the times when he ventured into the field of vaccinology. "Going down memory lane, when I started the company in 1966, I never dreamt that the Serum Institute of India, the name of which at that time was considered too large, would actually grow to its fullest potential. During those days, unlike today, we didn't have a proactive biotechnology department. The industry now is a much more favorable place and aspiring biotechnologists today are much more fortunate. They would be able to go ahead much quicker than we did. We took 35 long years to come to where we are today. I want to share an important thanksgiving. I have six members in my team who have not only stood by me but also helped me to develop the company. The fact that they have been with me for 35 long years without giving me a heartache for even a single day, speaks volumes of their commitment not only to me but for the development of the vaccine technology and the progress of the company." "The performance of the Serum Institute of India and its contribution to vaccinology is not really here to be advertised as much it could have been. I have been known more for my racing and breeding personality famed all over the country and many of my racing colleagues are surprised as to why I took a sabbatical from the head of the Board of Administration of the Indian Association of Racing and Breeding. Perhaps when they see the BioSpectrum magazine, they would know why I gave up that love and passion of mine for more of a humanitarian cause than the high-profile racing," Dr Poonawalla said. "When we started, we brought the shortages of tetanus antitoxin to an end which was really an achievement at that time but when we went into vaccines, I realized that the real benefit to society could be given by making these vaccines available at affordable prices. If we can keep the price of the product low and give it directly to the consumer in the long run, the sale of that product is bound to increase. And this is what has happened with the Serum Institute of India. We are the lowest-priced in every product that we market not only in India but also across the globe and the result has been amazing. It seems quite likely that we can make India proud to be the number one manufacturer in terms of numbers of vaccines that children got, never in the value. The value would be one-tenth of the world but the number would touch two billion doses. My team and I hope to achieve this for India," he said. Aseem Chauhan, chairman, Amity Institute of Biotechnology, gave away the Entrepreneur of the Year award to Dr KK Narayanan of Metahelix. In his acceptance speech, Dr Narayanan attributed his success to the people of Metahelix. "This award does not entirely belong to me. I have to share with a number of people. If I am the face of Metahelix, my colleague and co-founder of my company, Gautham Nadig is the heart and soul. My other colleagues-Dr Ramanathan, who heads the genomics group, Dr Kataria who head the crop improvement group, Dr Sangam and many others form the limbs. Let me also use this occasion to acknowledge the support that we have received from NS Raghavan who happens to be the co-founder of Infosys and who has been our angel investor and his institution the Nadathur Holdings and Investment. V Sarangarajan who leads that institution is on our Board, and he has been a source of great encouragement and support. He allowed us the kind of flexibility that we needed," he said. "We are three-and-a-half years old today and I think we have done very well for this time. But we still have a long way to go. We would not have been able to put in this energy that we have put into building Metahelix if it was not for the support that we have had back from our families," he added. The Product of the Year award was presented by Uttara Das Gupta, general manager, State Bank of India, to Dr B V Ravikumar for JEV Chex, a diagnostic kit for Japanese Encephalitis, developed by XCyton Diagnostics Ltd. This award was sponsored by State Bank of India. On receiving the award, Dr Ravikumar said, "Napolean once said 'give me a few medals and I will win any war'. I always thought he overrated medals but having fought in the space where government is my regulator as well as my buyer, I have been really tired in these 10 years of fighting and this medal has rejuvenated me. I am willing to fight another 20 years in this space." He said, "Kiran Mazumdar Shaw has been one of my angel investors in the beginning and so many people worked for this product which was first funded by DBT and it was given to NIMHANS. Dr V Ravi developed this technology and he made it very robust and it is this year we thought we should make this kit. We went to DBT and asked them to do the technology transfer. I asked them in February first week and Dr Manju Sharma who was leaving at the end of February, within one month completed all formalities. One thing unique about this product is that it is especially for the masses. There are a few others who toiled for it-our research team headed by Dr Latha Lakshman which includes Balaji Chettiar, Sunil Govekar and Aditi Banerjee. They all have participated in the entire process with high spirits and it is because of their passion that I am here today." BioSpectrum-ABLE Industry Awards Dr Cyrus S Poonwalla, chairman, Serum Institute of India, receiving the BioPharma Company of the Year award from Dr A Ashok, deputy secretary and director of biotechnology, industries and commerce department, Government of Andhra Pradesh. Dr Jagadish Mittur, director of Monsanto Research Centre, receiving the BioAgri Company of the Year award from Shankaralinge Gowda, secretary, department of Information Technology and Biotechnology, government of Karnataka. BioSpectrum Jury member K V Balasubramaniam, managing director of Indian Immunologicals, Hyderabad, presenting the BioIndustrial Company of the Year award to Dr Arun Chandravarkar, president, Biocon Ltd. Abraham E Mathew, Chief Editor of BioSpectrum, presenting the BioServices Company of the Year Award to Dr Ferzaan Engineer, CEO, Quintiles. Dr M K Bhan giving away the BioInstitute of the Year Award to Prof. Aparna Dattagupta, head of the Department of Animal Sciences, School of Life Sciences, University of Hyderabad. Pradeep Gupta, managing director, CyberMedia and publisher of BioSpectrum, presenting the BioSupplier Company of Year award to Sanjeev Dhar of Agilent Technologies. This year BioSpectrum added a few more awards. The BioSpectrum-ABLE awards were picked up by the editors of BioSpectrum based on the results of the annual BioSpectrum Top 20-the annual survey of the Indian biotech industry. These awards were based on the survey findings reported in the August 2004 issue of BioSpectrum and were given in five key segments of biotech-biopharma, bioinformatics, bioindustrial, bioservices and biosuppliers. Also for the first time the BioInstitute of the Year was initiated on the basis of a survey done in November 2004 by BioSpectrum along with CyberMedia Research. The BioPharma Company of the Year award was given away by Dr A Ashok to Dr Cyrus Poonawalla of the Serum Institute of India which had a turnover of Rs 491 crore. The BioAgri Company of the Year award was bagged by MAHYCO Monsanto Biotech (India) Ltd which introduced the country's first Bt cotton seed. The award was given away by Shankaralinge Gowda, secretary, department of Information Technology and Biotechnology, government of Karnataka, to Dr Jagadish Mittur, director of Monsanto Research Centre. Biocon was adjudged the BioIndustrial Company of 2004. The award was sponsored by RK Institute of Management and Computer Science. BioSpectrum Jury member K V Balasubramaniam, managing director of Indian Immunologicals, Hyderabad, presented the BioIndustrial Company of the Year award to Dr Arun Chandravarkar, president, Biocon Ltd. Quintiles bagged the BioServices Company of the Year Award. The award was given away by E Abraham Mathew, chief editor, BioSpectrum, to Dr Ferzaan Engineer, CEO, Quintiles. The University of Hyderabad was adjudged the BioInstitute of the Year. The award was presented by Dr MK Bhan to Prof. Aparna Dattagupta, head of the Department of Animal Sciences, School of Life Sciences, University of Hyderabad. Pradeep Gupta presented the BioSupplier Company of Year award to Sanjeev Dhar of Agilent Technologies. N Suresh, editor, BioSpectrum, gave the vote of thanks. The principal sponsor for the BioSpectrum Awards Nite was Genome Valley, Hyderabad. The State Bank of India, the Amity Institute of Biotechnology and the RK Institute of Management and Computer Science were the other sponsors. While State Bank of India sponsored the Product of the Year Award, Amity Institute of Biotechnology supported the Entrepreneur of the Year Award. RK Institute of Management and Computer Science sponsored the BioIndustrial Company of the Year. Namratha Jagtap ]]> <![CDATA[Product of the Year]]> https://biospectrumindia.com/news/95/4414/product-of-the-year.html https://biospectrumindia.com/news/95/4414/product-of-the-year.html Fri, 17 Dec 2004 15:31:00 +0530 JEV CheX of XCyton Japanese Encephalitis detector Fact File â€¢ JEV CheX is a diagnostic kit for diagnosing Japanese Encephalitis, a disease that is specific and prevalent in rice-growing regions, especially in India. â€¢ The kit is a tool that can be used for early detection. The detection can, over a period of time, eliminate the disease. â€¢ There was no simple diagnostic kit earlier. It used to take 36 hours to do the testing and the components had to be kept at -700 C. JEV CheX has reduced the testing time to 3 hours and the test can be conducted in even public health institutes. â€¢ The project involved public, private partnership. â€¢ The product was developed even though the market for this is very small. Dr Banda Venkata Ravi Kumar, chairman & managing director, XCyton Diagnostics Limited, Bangalore has made a big difference to the diagnostic market. He started the company in 1993 with a mission to develop, manufacture and market diagnostic kits for infectious diseases. The company developed the first indigenous kit to detect antibodies to HIV 1 and 2 called HIV-CheX. It introduced its second product, a detection kit for a parasite in brain in the year 2000, called CYSTI-CheX. The third product, HEP CheX, a Hepatitis detection kit, was launched in 2001. Xcyton's latest product JEV CheX, a detection kit for Japanese Encephalitis, was launched in June 2004. "We were approached by an US-based organization called PATH, Programme for Appropriate Technologies for Health, last December to develop a kit for Japanese Encephalitis. Despite the fact that it would not be economically feasible for us to develop the kit, it was our determination and a sense of commitment to eradicate Japanese Encephalitis (JE) from the country that made us take up the challenge. A lot of money and efforts went into developing this kit which was ready by June this year, and it was subjected to clinical trials at the National Institute of Mental Health Neurosciences (NIMHANS), Christian Medical College, Vellore and King George Medical College, Lucknow", said Dr B V Ravi Kumar. Giving details about the kit he said, "The JEV CheX is a rapid ELISA kit for the detection of IgM antibodies against JEV in Human CSF and serum. This kit has been developed in collaboration with NIMHANS. The research for this was conducted at Department of Neuro-Virology, NIMHANS, Bangalore, National Institute of Immunology, New Delhi and K.G. Medical College, Lucknow under the DBT umbrella programme. I am proud to say that for the first time this is a 100 percent DBT-funded, multi-institutional venture, and the leader of technology is of course NIMHANS." "Right now we have taken up the marketing and will continue to nurture the product for another year or so. This gives us the feel of how the product moves and an idea of the technical support that the customers may require," Dr B V Ravi Kumar said. "Each test will cost about Rs 120," he added. The team at XCyton Diagnostics Limited: LtoR - Sunil Govekar, Aditi Banerjee, Dr B V Ravi Kumar, Dr Latha Lakshman and M Balaji Chettiar. "The unique features of the JEV CheX are â€“ it is IgM capture ELISA, which eliminates competition with IgG and thus helps in diagnosing recent infection. It uses cell culture antigen and avoids preparation of antigen in suckling mice. It is a stabilised kit and can be stored at 40C for 6 months unlike the conventional test conducted at institutes which required storage of reagents at -700C. JEV CheX has an assay time of 3 hours when compared to the 36 hours of time taken by the conventional test conducted at public health institutes," Dr Ravi Kumar informed. The other products developed by XCyton in the past include HIV-CheX, CYSTI-CheX and HEP CheX C. Each one of them has been unique. HIV-CheX is an ELISA kit for the detection of antibodies to HIV 1 and 2 in serum and plasma. The kit has incorporated peptides of HIV 1 C in addition to the peptides of HIV 1A & 1B. HIV 1C causes 95 percent of Indian HIV infections and more than 60 percent of HIV infections in the world. HIV CheX is in the list of kits approved for usage in blood banks by the Drug Controller General of India and WHO has evaluated this kit at ITG Antwerp, Belgium. CYSTI-CheX is a detection kit for neurocysticercosis, a disease very prevalent in Latin America and China apart from India. This is the product of research conducted at Astra Research Centre India, Bangalore which was the tropical disease centre for Astra AB, Sweden (now called Astra Zeneca). CYSTI-Chex was launched in April 2000 and is a patented product of Astra Zeneca, Dr B V Ravi Kumar being the inventor. This is the only kit in the world market which uses excretoryâ€“secretory proteins of Cysticercus cellulosae as antigens, the metabolic product of live Cysticerci maintained in vitro. These are the only antigens seen by the human immune system. The kit is a special tool for neurologists to distinguish between Neurotuberculosis and Neurocysticercosis. XCyton's HEP CheX C is the only indigenously developed ELISA kit, in collaboration with International Centre for Genetic Engineering and Biotechnology and All India Institute of Medical Sciences (AIIMS). It is the only HCV ELISA kit to incorporate antigens from the 2b and 3g subtypes of the virus, which are prevalent in India. Imported HCV kits lack in this regard and are totally based on 1a subtype. The company has been licensed to manufacture and market HIV-CheX, CYSTI-CheX and HEP-CheX C by the Drug Controller General of India. The kits developed by XCyton are in the list of kits approved for usage in blood banks by the Drug Controller General of India. Its HIV-CheX kit is in the bulk purchase list of WHO and is purchased by WHO. For developing new technologies and products, it has strong technical collaborations with premier institutes in India such as IISc, Bangalore, NIMHANS, Bangalore, ICGEB, Delhi, TRC, Chennai, AIIMS, New Delhi, DRDE, Gwalior Vipra Inc. USA. Namratha Jagtap with Ch. Srinivas Rao ]]> <![CDATA[Person of the Year]]> https://biospectrumindia.com/news/95/5279/person-of-the-year.html https://biospectrumindia.com/news/95/5279/person-of-the-year.html Fri, 17 Dec 2004 15:18:00 +0530 Dr Cyrus S Poonawalla The 'King of Sports' and a vaccine maker Fact File of Dr Poonawalla Position: Chairman â€“ Serum Institute of India Ltd Age- 60 years Academics: Did his masters in biotechnology in UK and was awarded PhD by University of Pune in 1988 in the inter faculty thesis titled "Improved Technology in the manufacture of Specific Antitoxins and its Socio Economic impact on the Society". Family: Married to Villo Poonawalla. The couple has a son â€“ Adar, who is now working with his father to take Serum Institute to new highs. Entrepreneurship: Started Serum Institute in 1966 at the age of 22 Passion: Cars, horses Other hats: Chairman of several other engineering, finance and export companies, President of Serum Institute of India Research Foundation, patron of Indian Academy of Vaccinology & Immunology, member & trustee of Governing Council, National Horse Breeding Society of India, Member of the steering committee of the Developing Country Vaccine Manufacturers Network, member of the National Institute of Biologicals (Ministry of Health and Family Welfare, Government of India), the member of the Equine Development Board (Ministry of Agriculture, Government of India). Honors and awards: Man of the Year- Mother India International Gold Award in January 1991, Man of the Year â€“ Shiromani Award in Feb 1991, Lifetime Achievement award from the Turf Authorities of India in 1997, Hall of Fame Award 2002-03, Champion Breeders Award on five occasions 1997-98, 1999-2000, 2000-01, 2001-02 and 2002-03, Gold Award from the British Medical Association for the film Snakebite in 1987, Outstanding contribution Award in developing Pharmacy profession in India (Dec ember 2002), Gold Award Certificate as Trustee on behalf of the Pune District Leprosy Committee from the British medical Association for the film Sweekar (acceptance) in 1990, CHEMEXIL Award for outstanding export in 1994-95 and Pune's Pride Award in 1998 for excellence in the corporate world. Papers and publications â€“ Book titled Information Support for Immunization Program in India and book titled â€“ Management Issues of Immunization Program Published other scientific papers on Indian and International biotechnology in journals of repute. Brief - Dr C S Poonawalla contributed significantly in developing Serum Institute of India Ltd in the last 30 years as one of the world's largest manufacturers of measles and DPT (Diphtheria, Pertussis and Tetanus) group of vaccines. From a 20-man operation, the Serum Institute of India has grown to become the country's leading vaccine manufacturer boasting of revenues to the tune of Rs 555 crore. A man of few words and a man who lets his work speak for itself...that's Dr Cyrus S Poonawalla for you A horse! a horse! my kingdom for a horse â€“ King Richard III Ask the dapper Dr Cyrus Poonawalla whether he would have done the same. And he gesticulates â€“ a horse head shaped gold ring glinting on his finger. Rings of smoke fill the well-designed board meeting room reflecting his passion for horses. The trademark cigar is in place. So are his priorities. "Horse racing is agony and ecstasy. At the Serum Institute, the agony is much less and there is a sense of satisfaction for having done something for the masses." Owner of the Poonawalla Stud Farms, he sponsors the richest juvenile race in the country - - the Poonawalla Breeders' Multi Million. For someone who finds himself in print for his passion for cars - the president's six-door Mercedes, a fleet of stretch limousines and Rolls Royces, he maintains a low profile on the vaccine front. BioSpectrum caught up with him at Serum Institute of India Ltd, on the outskirts of Pune for an exclusive interview to find out more about his journey through the 'License Raj' system. Reasons for commencing Serum Institute "During my college days I had an active interest in the family breeding establishment now known as Poonawalla Stud Farms, inherited from my father Soli A Poonawalla. Obviously I took great interest as horse breeder and race owner and administrator. Horses are a passion for me. However, in the 1960s when I decided to go in for a career, it was clear and obvious to me that in a socialist country like India, the "King of Sports' has no place of future as an economically viable business career to pursue." "I was looking for something to do for the masses. In fact, I built a prototype for a sports car during my college days. But that was too ambitious a project to launch," he recalled puffing away his cigar. "A thought was suggested by Dr Balakrishanan, a veterinary surgeon who was a consultant to our breeding farm. Why not put a laboratory to manufacture tetanus, antitoxin serum and anti snake venom serum since the source of raw material was from the discarded resources of plasma. These life-saving materials were in shortage in the country. The talk trigged into a concept which culminated into a small biological unit to manufacture serum with capital of around Rs five lakh or even less than that. " "To start with, our operation was very small with less than 20 staff. I contacted a retired director of Haffkine Institute, Mumbai â€“ the first biotechnology institute in the country- through our family doctor Dr Jal Mehta. I was fortunate enough to get scientists from Haffkine Institute, who were experienced to develop these biological products. So a complete indigenously built small-scale unit was born in 1966, which commenced the manufacturing in late 1967." Hurdles The road to establishing the unit was not smooth. He faced many challenges in terms of finances and from the government. Commenting on the problems Dr Poonawalla, who started Serum Institute with his brother Zavary Poonawalla with the support from Dr Jal Mehta, S R Mundra and PK Sholapurwala noted, " I faced tremendous challenges during the socialist period. Securing permission for construction, power, and drug licensing - all were new to us. With no help or support from the government authorities, it was really a very challenging part of my career, which commenced with little in my pocket to take care of such situations." "After the first product 'tetanus antitoxin' was launched in 1968 we were able to grow and take finances from banks," observed Dr Poonawalla. Then Serum rolled out many other products -- anti serum vaccines, diphtheria, tetanus and pertussis vaccines. It was a sort of rise upwards for Serum Institute and there was no looking back. All these products are in short supply and India was completely depending on UNICEF and imports. With the entry of Serum Institute and making of these biotechnology products (vaccines) by Serum Institute, India became self-sufficient. Serum Miles 1967: Operations started with manufacture of Tetanus Antitoxin followed by fluid Tetanus Toxoid 1977: Autonomous scientific wing, Serum Institute of India Research Foundation established 1993: Launches MR vaccine for the first time in India 1994: Commences export of vaccines to UN agencies 1997: Commences export of anti- cancer products 1999: Got recognition as the largest producer of measles and DPT vaccines in the World 2000: One out of every two children in the world vaccinated by Serum's vaccine 2001: Launches indigenously manufactured recombinant hepatitis B vaccine called GeneVac B 2002: Launches BCG vaccine 2004: Launches Rabies vaccine Similarly the company's charter was defined by the conditions prevailing at the time: an acute shortage of tetanus antitoxin in the country and the practice of importing and retailing vaccines at high prices. Serum Institute aimed at total indigen-ization to make India achieve self â€“sufficiency in life saving drugs at affordable and effective prices. Price is a key factor "Price has been a major factor. It governs my vision even today from both socialist and humanitarian grounds. India needed these immunobiologicals desperately to protect the interest of patients who were dying without these products. This is in direct contrast to racing which is my passion and is the other side of my life." Making a strong point on the price factor, which never came in the growth of the company, he said, "We always kept the prices at low level. What we have done and even today we have maintained the prices at much lower level as the products are in shortage in the market." "One product later, we worked on another. Naturally the team grew. We plough back all profits into the company. I never issued dividends for atleast 30 years till recently. So the company became independent from all financial requirements and became a debt free company," adds Dr Poonawalla. "I may confess that there were very low overheads as land and other infrastructure that belongs to the farm was made available to my family. We did not have high overheads. No advertisement costs as the products were in great demand and till today we kept a very low profile and low overhead administrative costs compared to other biotechnology companies in the country, "said Dr Poonawalla. However, the major breakthrough for Serum Institute's products and company came after a long struggle in 1994 when it received the accreditation from World Health Organization (WHO) and pre qualified to supply for the United Nations agencies such as UNICEF and PAHO (Pan American Health Organization). Thereafter, there was a meteoric rise in the turnover of Serum Institute. Serum Institute also financed a film called 'Snakebite' in 1986, which received international film festival awards. Serum was recognized as the largest producer of measles and DTP vaccines in the world in 1999. A year later, it added another feather to its cap by becoming the only company in the world to have one out of every two children vaccinated with its products. " We have the largest sale of measles vaccines and leader in DPT and MMR vaccines in the world with manufacturing capacity of 170 million doses per year for DPT and 300 million doses per year for MMR vaccines. We have already the met the total demand of the Indian market. There is no additional demand left for these two group of vaccines. Presently, we are focusing on other range of products like Hepatitis vaccines, Rabies vaccine, BCG, TB vaccines. On overseas market Around 85 percent of revenues of Serum Institute are from overseas markets, chiefly UNICEF and WHOM organizations and remaining 15 percent come from India. The products are available in over 138 countries across the world. The major customers are UN agencies like UNICEF, PAHO and WHO, which mainly meet the demand in South American countries, Egypt, Africa, Caribbean countries. Sharing his thoughts on entering the regulated market, Dr Poonawalla said, "We have to go through local partners. Instead of trying to look at new markets we are interested in launching newer products in the existing markets where we are well-established and are well known, so that we can increase our product range rather than increasing the pace. Most of these are healthcare products of pediatric range. That means we need so many more vaccines. We want to cover more range of vaccines. That itself will be of immense potential." Serum Institute continues to share its philosophy of care across many more shores. Its millennium endeavor is to produce vaccines that would be administered to up to 75 percent of the new-borns of the world. "AIDS vaccine is my eventual goal" Interview with Dr Cyrus S Poonawalla What is the significance of R&D for Serum Institute of India? I don't think that we are poised to do a fundamental research. We are in much better position to do applied research and take on going to concept /gene/clone technology, pilot scale technology that is already established by researchers/scientists across the world and then do the R&D on the actual development of the product and scale up of the product with very high quality and yield production . This way we get quality products at low cost so that we can enter the market at low cost and make it available to masses. We generally contact a lot of intentional laboratories and not the Indian R&D organizations. We have taken the technology and concepts from them without actually making tie-ups as far as possible for technology transfer and that is where our in-house R&D comes to play. This has saved us millions of dollars for technology transfer and royalty. We purchase initial technology and customize it. That is the key. The secret of our success is to be low cost, completely indigenous and completely Indian. Each department in Serum has its own built-in R&D facility. So you can say that almost 25 percent of our premises is used for R&D facilities. What model has Serum adopted for its success? The model for the success of Serum Institute has been maintaining a totally indigenous and low cost products, self-reliance, minimum advertisements and publicity costs, low overheads. Therefore a low cost on the product with very high volume. Our major secret is extremely high volume, which brings down the cost and that is a risk I could take. For example a plant was required for producing 50 million doses per year as a good project. I ventured into making 100-200 million doses per year. What impact did the landmark visit by Dr Jonas Salk to Serum Institute have on you? The landmark visit of Dr Jonas Salk of Salk's Polio Vaccine fame and inventor of the injectable polio vaccine encouraged me to make a combination vaccine with the support of Department of Biotechnology which was successfully launched in late 1980s but the government of India came in the way because the oral polio vaccine, they felt, would be threatened which is one of the many examples of their attitude towards private sector vaccine manufacturer as they are desperately ambitious to protect the inefficient public sector vaccine manufacturers that they were to look up. I was forced to withdraw the product. The Serum Institute's products are sold at lesser price as against multinationals. Don't you feel that this will hinder the growth of the company? Logically it is a great financial advantage one should take. This strategy has paid us and discouraged competition. When we first launched anti tetanus vaccines, Glaxo was the leader. Within five years, it decided to drop this product from the market along with DTP (triple antigen) that they were manufacturing. The MNCs even today find it impossible with all their drug discoveries and technologies to take us on. Now the industry trend is towards joint ventures, partnership? To what extent do you agree? I don't believe in any partnership with multinationals because they have been one-sided. I believe in taking technology and having an alliance on technological front. What is your ultimate goal? AIDS vaccine is my eventual goal. But it will take 5-10 years because unless the basic technology is proven and established, there is no point in making tall claims at this stage. But we definitely will be a candidate of choice for the government of India to select us based on our wide experience, available resources, infrastructure facilities, man power to make an affordable and effective AIDS vaccine for the country. "We have an ambitious project at Pune wherein we are investing Rs 200 crore. It is expected to be completed during the next financial year. The facility will manufacture combination vaccines mainly for pentavalent vaccines (DPT HepB and Hib), which is most sought after by the Global Alliance of Vaccine Initiative, a world body funded by Bill Gates Foundation, UNICEF, WHO, World Bank." To tackle competition from local as well as multinationals the Serum Institute has chalked out a road map for the next three years. "The road map is very clear. We want to become a world leader in pentavalent vaccines and also want to enter the regulated markets like USA and Europe market where the product is sold at 10 times of the price what we get from UNICEF. We also want to become strong in anti cancer products in India and US market, as a lot of products will become off patents in USA. We are already manufacturing several anti cancer products. Now we are putting up a state of art facility for this, " he said. Dr Poonawalla is determined to retain the family control over the company. His only son Adar, who shares his passion for horses and cars and believes in professional management, has joined his father's vaccine manufacturing business. Adar Poonawalla informed that they would first take anti cancer drugs /products to the US markets and later on the vaccines. Role model A strong believer in himself, Dr Poonawalla noted, "No role models for me. I don't want to say things that people on the stage usually say. They thank their parents but they don't even say hello to them in real life. Nothing strikes my mind really...!" Asked if he would go through this struggle again, Dr Poonawalla summed up thus: "This is right. We may be number one in horse breeding and racing in India. But being a part of the growth of the biotechnology company is something else." Narayan Kulkarni with Nanda Kasabe in Pune ]]> <![CDATA[The Winners All The Way]]> https://biospectrumindia.com/news/95/6993/the-winners-all-the-way.html https://biospectrumindia.com/news/95/6993/the-winners-all-the-way.html Fri, 17 Dec 2004 15:08:00 +0530 The second BioSpectrum Awards selection was a breeze. One, we had the tested format and a tested practice. Two, the constitution of the Jury was simpler. The chairman of the jury by our practice has to be the winner of the Person of the Year Award in the previous year. Three, there was more knowledge about the industry. Four, the Award Categories were well defined. The Chosen Ones Life Time Achievement Dr Manju Sharma, former secretary, Department of Biotechnology Person of the Year Dr Cyrus S Poonawalla, chairman, Serum Institute of India Entrepreneur of the Year Dr KK Narayanan, managing director, Metahelix Product of the Year JEV Chex, Japanese Encephalitis diagnostic kit of XCyton State of the Year The jury decided not to give this award as none of the states measured up to the levels expected of a winner. In sync with what was done in 2003, the Jury was constituted as early as September first week and the first and only meeting was held on October 18, 2004. The jury met at Biocon. The practice is to meet in the office of the chairperson of the jury. The chairperson of the jury was Ms Kiran Mazumdar-Shaw, the winner of BioSpectrum Person of the Year 2003 Award. She is the chairman and managing director of Biocon Ltd and president of Association of Biotechnology Led Entrepreneurs (ABLE). BioSpectrum selected the remaining jury members to bring wide expertise from various fields to the process. Ms Kiran Mazumdar-Shaw and Mr KV Balasubramaniam, managing director, Indian Immunologicals, represented the private and public sector enterprises respectively. Prof. K VijayRaghavan, director, National Center for Biological Sciences, who has been actively involved in research, brought the thoroughness of the academic to the whole exercise. Mr Aluri Srinivasa Rao, director, investments, ICICI Venture Funds, Mumbai, was at hand to look the personalities and companies from a venture capitalist's perspective. The two representatives from the media were Mr Pradeep Gupta, pubisher of BioSpectrum and managing director, CyberMedia. and Mr Abraham Mathew, chief editor, BioSpectrum. Having two representatives from Cyber Media India Ltd is a dedicated practice followed by the group ever since it had established the first Awards for the IT industry - DATAQUEST IT Man of the Year as early as 1993, when the IT industry in India itself very small. Jury Deliberations The Jury Mrs Kiran Mazumdar-Shaw, chairman and managing director, Biocon Ltd Prof. K VijayRaghavan, director, National Center for Biological Sciences Mr Aluri Srinivasa Rao, director, investments, ICICI Venture Funds Management Co. Ltd Mr KV Balasubramaniam, managing director, Indian Immunologicals Mr Pradeep Gupta, managing director, Cyber Media India Ltd Mr Abraham Mathew, chief editor, BioSpectrum, Cyber Media (India) Ltd, Research Team N Suresh, Editor, BioSpectrum Ch. Srinivas Rao, Sr Assistant Editor, BioSpectrum The category of the Awards was not a dilemma in 2004. The industry has widely accepted the four categories of Awards instituted last year. These Award categories were Life Time Achievement, Person of the Year, Entrepreneur of the Year and Product of the Year. In 2003, it was decided to institute a Special Category Award. This was the State of the Year. During the deliberations, the jury decided not to select the State of the Year Award as most of the states were reeling under the preparation for the elections and also not much has happened in the states in terms of concrete progress in promoting biotechnology. Several states announced their commitments, but it was too little to gauge the progress made. The Board was unanimous in the selection of all the awards. Dr Manju Sharma was chosen the winner for the Life Time Achievement. "Dr Manju Sharma started the Department of Biotechnology almost with no funds. She was taken from the Department of Science & Technology and did all the groundwork and created a good department and several institutes which are doing very well. She is a catalyst," observed Prof. K Vijay Raghavan. Mr Balasubramanian pointed out that she had the ability to get the successive governments both at the Centre and the states to commit to the development of biotechnology. Further, as she retired from her position as secretary of DBT in March 2004, it was the appropriate time to confer her the Award. "The relevance of Life Time Achievement will be lost, if the Award is not presented at the appropriate moment. And it would mean nothing thereafter," supported Mr Pradeep Gupta. The Person of the Year was Dr Cyrus S Poonawalla, chairman, Serum Institute of India. The choice again was unanimous. Serum has put India very strongly on the platter of vaccines manufacturing capability globally. Poonawalla's ability to navigate through the times of controlled environments of the government to make Serum a world leader in vaccines is noteworthy. The Entrepreneur of the Year was Dr KK Narayanan, managing director, Metahelix. He is a first generation scientist-entrepreneur in the family and in just three years, has catapulted Metahelix to a hot shot BioAgri company. Not just that, he has successfully balanced research and evolved a steady revenue stream through services. Besides, Narayanan has been very active stakeholder in the draft recommendation for the MS Swaminathan Task Force Report on application of biotechnology in agriculture. The last in the round of discussions was the Product of the Year Award. Again, it was a choice that had little deliberation. There were very few products introduced in the past year. Most of the products that were introduced were in the informatics categories. XCyton's JEV Chex, a diagnostic kit for Japanese Encephalitis Virus was chosen. The diagnostic kit was developed as a public-private initiative and was developed to suit to the disease, which is widely prevalent in many parts of India â€“ a home-made product for country-specific disease suiting to Indian terrains of storage and climate. The Awards will be presented on December 10, 2004 at Hotel Leela Palace in Bangalore. BioSpectrum-ABLE Industry Awards BioSpectrum-ABLE Industry Awards (based on the industry survey in August 2004) BioPharma Company of the Year Serum Institute of India BioAgri Company of the Year MAHYCO Monsanto Biotech (India) Ltd BioIndustrial Company of the Year Biocon Ltd BioServices Company of the Year Quintiles India BioSupplier Company of the Year Agilent Technologies BioInstitute of the Year * University of Hyderabad * ( This award is based on the India's Best BT-Schools Survey done by BioSpectrum) This year, BioSpectrum has added a few more awards this year. These awards are BioPharma Company of the Year - Serum Institute of India; BioAgri Company of the Year -MAHYCO Monsanto Biotech (India) Ltd; BioIndustrial Company of the Year - Biocon Ltd; BioServices Company of the Year- Quintiles; BioSupplier Company of the Year -Agilent Technologies; and BioInstitute of the Year - University of Hyderabad. These Awards have been picked by the editors of BioSpectrum primarily based on the results of the annual BioSpectrum Top 20-the annual survey of the Indian biotech industry. The methodology is straightforward. The survey findings were reported in the August 2004 issue of BioSpectrum. Five key segments of biotech-biopharma, bioagri, bioinformatics, bioindustrial and bioservices-were analyzed and the top companies in each of these segments was identified based on the sales revenue figures for the FY 2004, except for the bioinformatics segment. Hence, an award was chosen for each of these segments except informatics. Similarly, the BioSuppliers segment was analyzed in the same survey and the top company identified. The BioInstitute of the Year has been awarded on the basis of a survey that was done in November 2004 by BioSpectrum alogn with CyberMedia Research. The University of Hyderabad ranked the highest in the survey. In the ensuing pages, BioSpectrum presents the profiles of each of the BioSpectrum Awards. N Suresh and Ch. Srinivas Rao ]]> <![CDATA[Monsanto to invest in regional seed firms]]> https://biospectrumindia.com/news/95/1972/monsanto-to-invest-in-regional-seed-firms.html https://biospectrumindia.com/news/95/1972/monsanto-to-invest-in-regional-seed-firms.html Thu, 16 Dec 2004 13:24:00 +0530 Monsanto to invest in regional seed firms Monsanto announced the formation of American Seeds Inc. (ASI), a new holding company, to support regional seed businesses with capital, genetics and technology investments. These investments will allow the operating companies of ASI to more directly connect their customers to significant innovations in genomics-based breeding and other new technologies while continuing to operate autonomously and locally, providing great service to their customers and building the value of their brands. Kerry Preete "The pace of technological innovation has changed the seed industry and it's clear in conversations with some of our seed-company customers that the needs for capital and technology for growth have accelerated," said Carl Casale, executive vice-president, Monsanto. "In recognizing these needs, we developed ASI as a vehicle to allow regional seed companies to gain faster and better access to capital, genetics and technology while preserving the brands and approaches that their customers know and trust." ASI is a wholly owned subsidiary, reporting into Monsanto's U.S. Crop Production business along with the company's existing branded and licensing businesses. "Within our U.S. business we now have three approaches to the market, each serving unique customers in unique ways," said Kerry Preete, vice president of U.S. Crop Production for Monsanto. Sanofi-Aventis, CDC to launch biotech venture capital fund Sanofi-Aventis SA and the state-owned Caisse des Depots et Consignations (CDC) have announced the launch of a new venture capital fund that will invest in the biotechnology sectors. The two are understood to have invested a total of 75 million Euro in the fund. Sanofi-Aventis and CDC have invested equally and the new fund, called Pharmavent, will invest in companies with products entering the clinical development phase. The Pharmavent funds will have a European vocation and will be largest French funds specialized in the life sciences. Pharmavent will be created in the form of Investment funds at the Risks (FCPR) with procedure reduced of French right and will be dedicated to investments of venture capital. It will be managed by an independent trust company. "The Pharmavent fund represents a new phase of expansion of our activity in the field of the venture capital. This initiative should enable us to develop our network of partners in our key therapeutic fields," declared Patrick Langlois, vice-president and chief financial officer, Aventis.On his side, Albert Ollivier, president, CDC SME, specified, "In the development of the companies of biotechnologies, Pharmavent corresponds to the missing link: that of the financing of the clinical phases, which are very expensive and for which the French and European existing funds are rare. CDC SME thus confirms its role structuring on the market, after the launching of the funds of Bioam bio-starting in 2000 and of the funds of Co-investment for young companies (FCJE) in 2002." Amgen announces Amgen Ventures to fund start-ups Amgen Inc., the world's largest biotechnology company, announced Amgen Ventures, a corporate venture capital fund designed to provide emerging biotechnology companies with resources to develop pioneering discoveries focused on human therapeutics. Amgen Ventures is an important component of Amgen's overall outreach strategy. Amgen Ventures can offer early stage companies access to Amgen's extensive capabilities while providing Amgen with insight into external research innovations that may pave the way for future collaborations. With an initial commitment of $100 million, Amgen Ventures intends to invest in early-stage biotechnology companies focused on discovering and developing human therapeutics. The focus of the fund primarily will be in areas of current therapeutic interest to Amgen, but will also include novel modalities with the potential to address targets in both current and emerging therapeutic areas of interest. Amgen Ventures will be based in San Diego and will leverage existing Amgen sites including Seattle, San Francisco, Thousand Oaks, and Boston. ]]> <![CDATA[Kendro]]> https://biospectrumindia.com/news/95/5409/kendro.html https://biospectrumindia.com/news/95/5409/kendro.html Thu, 16 Dec 2004 13:23:00 +0530 Kendro's offers Series 7000 Function Line Incubators Series 7000 Function Line incubators from Kendro Laboratories are equipped for numerous routine microbiological incubation processes. The incubators come standard with an independent, adjustable over temperature controller. A large digital display simplifies operation and control. Instruments are available as gravity (B series) or mechanical (UB series) convection models in three sizes. Integration of the control panel into the front door makes the footprint of the incubators exceptionally small. Smooth inner chamber stainless steel surfaces and rounded corners allow easy cleaning and prevent contamination. Excellent temperature uniformity and state-of-the-art microprocessor control ensure high reproducibility. For details contact: info.in@kendro.spx.com Ocimum offers iRNAchek iRNAchek, a bioinformatics tool developed by Ocimum Biosolutions, provides a comprehensive and intuitively designed environment for organization of sequence data, design of siRNAs, and tracking and analysis of successful templates. It provides a facility to design the siRNA based on the regions of interest. These regions can be set based on open reading frames, introns, exons, UTR regions and other sequence annotations. There is also a provision to eliminate templates from specific regions. It is very essential to design siRNA targets that do not fall within functionally significant motifs and domains of the sequence. iRNAchek takes care of this efficiently by the use of a filter to refine the results based on motif and domain search. iRNAchek helps the user select specific siRNAs using intuitively designed BLAST tool. Using this tool the user can search for potential matches from NCBI database or can create his own proprietary database and search for matches against proprietary databases for possible matches. For details contact: hyd@ocimumbio.com Lab Vantage offers Sapphire Life Sciences LIMS LabVantage developed Sapphire Life Sciences LIMS exclusively for the Life Sciences sector to enable the researchers to focus on their core competencies, while eliminating the research bottlenecks. Sapphire enables science with intuitive, intelligent, and precisely traceable sample management. It provides a full-featured, flexible experiment management capability that's applicable in genomics, proteomics, and HTS. This enables rapid automation of experiments and studies, with smart visual objects designing the specific lab's experiments and protocols. Sapphire provides complete plate management solutions for integration of cherry picking, transferring, loading and more. The multi-faceted Sapphire solution thrives on managing multidimensional arrays. From flexible pattern-specific loading, cherry picking, and re-arraying - to multiple media types including DNA Chips for genomics and IPG Strips - to gradient gels for proteomics. It supports all documentation needs for 21 CFR Part 11 compliance. Sapphire fully supports 21 CFR Part 11 compliance and is deployed as a "closed system" or an "open system with appropriate controls." Extensive data and sample management auditing capabilities are available for organizations requiring 21 CFR Part 11 compliance. For details contact: akastuar@labvantage.com BioRad introduces VersArray Hybridization Chamber The VersArray hybridization chamber of Bio-Rad is specifically designed to increase the effectiveness of manual (coverslip) hybridization of microarrays. The chamber accommodates one or two slides, allowing the simultaneous processing of two microarrays. Loading is simple - the chamber is easily opened and closed using the single attachment bolt. A unique pressure mechanism*(*Patent pending) promotes a uniform and watertight seal, allowing incubation in a water bath. The aluminum composition ensures superior thermal transfer, while the water reservoirs prevent slides from drying out. The VersArray hybridization chamber is easy to use, protects the microarray slides, and provides the ideal environment for the cover slip hybridizations. For details contact: sales.india@bio-rad.com BD Bio sciences develops BD PuraMatrix The Discovery labware of BD Bio sciences has developed BD PuraMatrix Peptide Hydrogel. It is a synthetic matrix that is used to create defined three-dimensional (3D) microenvironments for a variety of cell culture experiments. To achieve optimal cell growth and differentiation, it is necessary to determine the appropriate mixture of this material and bioactive molecules (e.g., growth factors, extracellular matrix (ECM) proteins, and/or other molecules). BD PuraMatrix Peptide Hydrogel consists of standard amino acids (1% w/v) and 99% water. Under physiological conditions, the peptide component self-assembles into a 3D hydrogel that exhibits a nanometer scale fibrous structure. For details contact: bd_india@bd.com Custom-built magnetic mixers for Indian market Florence, Italy based manufacturer of agitators for pharma and biotech applications, Mariotti & Pecini (M+P) has introduced customised magnetic torque driven agitators and mixers for Indian market. The pharma and biotech industry in India hitherto had to be content with off-the-shelf catalogue models of magnetic mixers from overseas manufacturers. From now on, M+P and their agents TurbuLens Technologies, Bangalore will be able to offer customisation of shaft, impeller, mountings, and drive units for magetic mixers in top, bottom and side entry versions upto 10,000 litres vessels. Process parameters and operating conditions in cell culture reactors, microbial fermentors and media vessels and tanks demand special impeller profiles, shaft contour, bush mountings, bearings and speed control in mixers. With M+P, the customer can exercise his/her options on all these components that are crucial for process performance, product yield efficiencies and overall batch economics. From the point of view of regulatory bodies and facility audit magnetic mixers have ready acceptance as they support cGMP norms, CIP & SIP, batch containment and product integrity. For further info email to: info@turbulens.biz or info@mariotti-pecini.it SuperArray Biosciences launches GE Array systems SuperArray Bioscience Corporation, USA, has introduced nylon membrane-based cDNA array systems called GE Array Systems. These can profile the expression of multiple genes on a single array. Instead of including as many genes as possible on a single array, GE Array systems are designed to determine the expression of genes involved in a specific biological pathway, or genes with similar functions or structural features. The biological information provided in each array improves research productivity. The GE Arrays are available in two different formats: The GE Array Q Series cDNA expression arrays contain up to 96 cDNA fragments from genes associated with a specific biological pathway as well as four housekeeping genes whereas the GEArray Original Series gene arrays contain up to 23 cDNA fragments from genes associated with a specific biological pathway as well as two housekeeping genes. SuperArray Biosciences also provides three types of cDNA probe synthesis kits viz. AmpoLabeling-LPR kit, TrueLabeling-RT kit and conventional RT-Labeling kit. These products are available in India through the Delhi-based Biotech India. For further details, contact: info@biotechindia.com SRP Enviro Systems offers bio-safe EEF filter units The New Delhi-based SRP Enviro Systems offers ultra high performance cleanroom filtration systems at low energy consumption 0.4 W/scfm and yet has enough fan power to overcome return and supply flow restriction. The higher efficiency enables lower airflow with significant energy savings. The installation and operating costs will also be on lower side. There is no contamination during filter servicing. The terminal HEPA filters, if required, should never need changing. It can be easily upgraded from the existing cleanrooms and the cost involved in conversion of dry wall rooms will be inexpensive. There is no contamination during filter servicing. The filter requires minimum 30" service space on the side opposite the electrical box. For details contact: delhi@srpenviro.com Mycoplasma Detection Kit by R&D Systems R&D Systems, USA, has introduced a Mycoplasma Detection Kit. The "Mycoprobe" Mycoplasma Detection Assay is a 4.5-hour colorimetric micro plate assay designed for routine screening of mycoplasma contamination in cultured cells. This assay detects Mycoplasma 16S ribosomal RNA (rRNA) using a colorimetric signal amplification system with sensitivity comparable to PCR. However, the MycoProbe assay is not susceptible to common problems encountered with PCR-based mycoplasma detection kits. The MycoProbe assay detects approximately 95 percent of all mycoplasma contaminations. This assay can be used to detect mycoplasma contamination using either cell culture supernates or cultured cell pellets. Samples are prepared by dilution in the lysis buffer provided in the kit. Passage of cultured cells in antibiotic-free media is not required. The strip-well microplate format is amenable to a small number of samples as well as application requiring high sample throughout. The product is being distributed exclusively in the country by Delhi-based Biotech India. For further details, contact: info@biotechindia.com Toshibha offers biological safety cabinets The Biohazard Cabinet from Toshibha (India) offers operator protection from low to moderate risk biological agents or chemical carcinogens (while providing a sterile work environment for the procedure). The applications of these biological safety cabinets (Biohood) / class II biological safety cabinets include isolation and identification of plant/human pathogens, work in virology, tissue culture, sterility testing and recombinant DNA research. These cabinets are suited for wet processing, water fab, chemical work, critical biological work involving virus and pathogens and for microbiology, biochemistry etc. The built-in-positive air curtain effect will prevent inside air from going out and room air from entering in, there by providing a total process and operator safety. For details contact: toshiba@del3.vsnl.net.in ERBA Chem 5 Plus from Transasia ERBA Chem 5 Plus from Transasia Biomedicals is a sophisticated Semi-Auto Clinical Chemistry Analyser. Its advanced and unique optics technology combines the proficiency of eight individual photometers and ensures long life and high precision. It has versatile analytical options such as Endpoint (Linear & non-linear), Kinetic and Fixed time, in Monochromatic and Bichromatic modes. It displays, prints and memorizes graphs of all linear and non-linear reactions. It has a built-in self-diagnosis that ensures simple and safe maintenance. ERBA Chem 5 Plus is an economic system as it uses only 200-500 µl reagent per test and it has unique plug-in memory chip for future up-dating and expansion. For details contact: webmaster@tbm.net Millipore, Caliper Life Sciences introduce validated automation protocols Millipore Corporation and Caliper Life Sciences have announced the availability of three new validated protocols to automate drug discovery applications. The methods for 96-well solubility, PAMPA and permeability assays were developed using Millipore's MultiScreen® assay systems and Caliper's Sciclone ALH 3000 Liquid Handling Workstation. The integrated solutions ensure hands-free operation and maximize productivity. The Caliper Sciclone ALH 3000 Liquid Handling Workstation offers leading-edge precision, adaptability, and scalability, enabling the efficient automated processing of 96, 384, and 1536-well microplates for life science research and diagnostic testing. Leveraging a unique, open and modular design along with a wide range of interchangeable pipetting options and accessories, the Caliper Sciclone workstation can be configured to automate many applications, from nucleic acid and protein sample preparation protocols to molecular and cell-based screening assays, and more. Millipore's MultiScreen Solubility Assay System, MultiScreen Permeability filter plate, and MultiScreen filter plate for PAMPA are part of a family of optimized ADME (absorption, distribution, metabolism and excretion) assays. Developed to effectively screen drug compounds in the early stages of discovery, the MultiScreen pre-ADME and ADME profiling tools are designed to improve lead predictability and increase productivity. The company's ADME offering also includes the MultiScreen Caco-2 Assay System for cell-based absorption assays, MultiScreen Ultracel®-PPB filter assembly for plasma protein binding, and the MultiScreen Solvinert filter plate for total drug analysis. ]]> <![CDATA[Agilent, ExonHit work together to optimize microarray technology]]> https://biospectrumindia.com/news/95/2864/agilent-exonhit-work-together-to-optimize-microarray-technology.html https://biospectrumindia.com/news/95/2864/agilent-exonhit-work-together-to-optimize-microarray-technology.html Thu, 16 Dec 2004 13:19:00 +0530 Agilent, ExonHit work together to optimize microarray technology Agilent Technologies and ExonHit Therapeutics, a private drug discovery company, announced a research collaboration to combine Agilent's microarray platform and ExonHit's alternative RNA splicing technologies and expertise. This collaboration explores the development of a microarray-based solution that will enable scientists to properly monitor the expression of splice variants. Splice variants are variable sequences of RNA produced from the same gene in DNA, resulting in the creation of different proteins potentially affecting cellular regulation. Scientists developing therapeutics are increasingly interested in this emerging field as the expression of splice variants can provide novel targets, may indicate disease states, and can be altered by exposure to drugs and toxins. Agilent and ExonHit are working together to optimize microarray design, reagent protocols and data analysis methods for splice variant studies. ExonHit realized that the proper characterization of splice variant expression required dedicated profiling platforms. The company has received notice of the allowance of its patent, which broadly claims nucleic acid arrays that enable the detection of alternative RNA splicing events via either intron or exon and splice junction-specific probes. Agilent is providing researchers highly flexible and sensitive printed microarrays. Initial results from an experimental splicing array of G-protein coupled receptors, designed by ExonHit and produced by Agilent pursuant to the collaboration, showed good reproducibility and specificity. The companies are expected to work with early test sites to generate additional experimental results. "Our mutual goal is to better enable alternative RNA splicing analysis using microarray technologies," said Fran DiNuzzo, vice president and general manager of Agilent's Integrated Biology Solutions business unit. "We are confident that our collaboration will result in scientists being able to conduct cutting-edge genomic research and to study more thoroughly the gene families and signaling pathways important for their research. The effectiveness of Agilent's microarray platform, combined with ExonHit's pioneering alternative RNA splicing technology and strong intellectual property position, will ultimately provide an ideal expression-profiling solution for researchers worldwide," said Bruno Tocque, CEO of ExonHit Therapeutics   Pall to acquire chromatography business from Ciphergen Biosystems Pall Corporation announced that it would acquire the BioSepra Process Division from Ciphergen Biosystems, Inc. at price of approximately $32 million. The transaction is expected to close within 45 days. The BioSepra Process Division develops, manufactures and markets chromatography sorbents that greatly simplify protein purification development and significantly improve biopharmaceutical-manufacturing productivity. Pall and Ciphergen also announced an alliance to develop and promote Ciphergen's patented SELDI ProteinChip® technology as a bridge between the research lab and large-scale drug production. This technology will be used to optimize chromatography resin selection for protein purification. Pall also plans to establish Process Proteomics Service Centers that will assist customers in selecting and optimizing sorbents and membranes for the purification of proteins used in the production of therapeutic proteins and other bioprocess applications. The addition of these sorbent technologies will enable Pall to provide a highly integrated solution for the bioprocess separations market. Eric Krasnoff, chairman and CEO of Pall Corporation, said,"BioSepra is a welcome addition to Pall's Life Sciences business. Their innovative and broad range of chromatography chemistries fit in well with our significant market position in drug discovery and protein purification. We are very pleased to strengthen Pall's ability to serve the needs of our Biotechnology customers." William E. Rich, president and CEO of Ciphergen, said, "We are excited about working with Pall and their customers to continue expansion of our pioneering work in Process Proteomics in order to speed process development using our ProteinChip Systems for protein purification and expression optimization and process monitoring."   Applied Biosystems introduces genetic analyzers Applied Biosystems, an Applera Corporation business, has introduced a new line of Genetic Analyzers for low-to medium-throughput laboratories. The Applied Biosystems 3130 Series Genetic Analyzers, which replace the ABI PRISM® 3100 and 3100-Avant Genetic Analyzers, deliver enhanced automation, faster turnaround times, higher reliability, and higher data quality than previous generation technologies across a wide range of applications, including de novo sequencing, resequencing, mutation detection, single nucleotide polymorphism (SNP) analysis, and microsatellite analysis. The Applied Biosystems 3130 Genetic Analyzer is a four-capillary system, and the 3130xl Genetic Analyzer is a 16-capillary system. Customers purchasing the 3130 System have the flexibility to easily upgrade their system to the 16-capillary 3130xl system if they require higher throughput in the future. The 3130 and 3130xl Genetic Analyzers were co-developed under a product development collaboration that began in 1997 with Hitachi High-Technologies Corporation, an affiliate of Hitachi, Ltd., of Tokyo, Japan. Clinical research trials represent a growing market opportunity for these systems, where sequencing can be used to correlate the clinical responses of patients to an experimental treatment and to indicate that patients with specific gene sequences may be more responsive to the potential therapies under investigation. "Even in today's post-human genome sequencing era, genetic analysis continues to play a vital and growing role in the life sciences industries," said Catherine M. Burzik, president of Applied Biosystems. "Our DNA analyzers are increasingly being used for such applications as genotyping and mutational profiling (resequencing), in addition to the ongoing genome sequencing projects," he added.   Thermo Electron's mass spectrometer wins R&D 100 Award One of Thermo Electron Corporation's flagship mass spectrometer, the Finnigan LTQ FT, has been selected by R&D Magazine as one of the top 100 innovative new products of the year. It helps the researchers involved with the study of proteomics. "This hybrid mass spectrometer, which also received the 2003 PITTCON Editor's Silver Award, enables the scientists to analyze complex mixtures more thoroughly and more rapidly than ever before. It allows analytical chemists and biologists to obtain higher quality data, giving them greater structural information. Its analytical capabilities contribute to the more efficient identification, characterization, and detection of proteins and their post-translational modifications (PTMs) with improved confidence and precision. At the same time, the instrument provides routine and user-friendly operation," said the official release. The R&D 100 Awards were established in 1963 to identify the 100 most technologically significant new products in the marketplace in that year. Over the years, the R&D 100 Awards have recognized winning products with such household names as Polacolor film (1963), the flashcube (1965), the automated teller machine (1973), the fax machine (1975), the liquid crystal display (1980), the printer (1986), the Kodak Photo CD (1991), the Nicoderm anti-smoking patch (1992), Taxol anticancer drug (1993), lab on a chip (1996), and HDTV (1998).   GE Healthcare announces collaboration with GSK GE Healthcare, announced an informatics collaboration agreement with GlaxoSmithKline (GSK) to enable GSK to integrate data from diverse internal and external sources in its drug discovery R&D process. GSK will be able to use geneticXchange's discoveryHub data and information integration software from GE Healthcare within its R&D areas of Genetics, Discovery and its Centres of Excellence for Drug Discovery and Pre-Clinical Development. This will help GSK to maximize its use of biological, chemical and clinical data generated from its own drug discovery research, and integrate it seamlessly with other third party and public databases. Under the terms of the agreement, GE Healthcare and geneticXchange will work in collaboration with GSK in the design, development and support of the next generation of discoveryHub technology." Effective informatics enable drug researchers to address one of the most difficult challenges in life sciences: transforming data into knowledge," said Nick Giannasi, Head of Informatics Solutions at GE Healthcare. "discoveryHub will support GSK in the efficient use of the available biological and clinical data in its drug discovery research. Connecting data sources regardless of location and complexity, discoveryHub provides scientists with access to the data they need in order to make informed decisions quickly," he added.   Cambrex, QBM Cell Science sign distribution agreement Cambrex Corporation has signed an exclusive distribution agreement between its subsidiary Cambrex Bio Science Walkersville, Inc. and QBM Cell Science. Cambrex Bio Science Walkersville is a supplier of human cell systems, with over 100 different cell and media systems for life science research. QBM Cell Science is a provider of primary neurons for the research market, including neuronal cells from mouse and rat cortex and striatum, and from the rat hippocampus. Under the agreement, Cambrex will exclusively distribute QBM neuron products through its existing global distribution infrastructure. "We are very excited about the agreement and the expanded research possibilities that it affords neuroscientists," commented Dave Eansor, president, Cambrex Bioproducts. "These products are complementary to our Clonetics® and Poietics® normal human cell systems. We believe our e-commerce capabilities and distribution channels meet QBM's requirements while addressing the need for quality neuronal cell systems by researchers worldwide." Anthony Krantis, president QBM Cell Sciences said, "Cambrex's worldwide reach and expertise in primary cell distribution will greatly increase the availability of our cells to the research community."   Eppendorf &Science prize for neurobiology 2004 goes to Miriam Goodman The "Eppendorf & Science Prize for Neurobiology," an international prize of $25,000, has been awarded to Miriam B. Goodman, Stanford University School of Medicine, California, USA, for her work on "Using C. elegans to Deconstruct and Reconstitute a Sensory Mechanotransduction Channel." The prize was presented recently in San Diego, California. Dr. Goodman is presently working as an Assistant Professor of Molecular and Cellular Physiology at Stanford University with focus on delineating the molecular events that give rise to the sense of touch. Research in Dr. Goodman's laboratory, which combines techniques in genetics, in vivo electrophysiology and heterologous expression, is directed toward the discovery of the molecular events responsible for this process. She grew up in Lexington, Massachusetts, and Bethesda, Maryland, writing scientific software in research labs at the National Institutes of Health (NIH) as a high school student. She earned a Bachelor's degree in Biochemistry from Brown University in 1986. As a graduate student in neurobiology at the University of Chicago, she analyzed voltage-dependent ion channels that tune vertebrate hair cells. After being awarded her Ph.D. in 1995, she pursued postdoctoral work in C. elegans neurophysiology and genetics at the University of Oregon and Columbia University. The Prize, which is sponsored by Eppendorf, is open to all young scientists who have made outstanding contributions to neurobiological research using methods of molecular and cell biology and have obtained their PhD or MD within the past 10 years. This year's winner was selected from a pool of approximately 40 applicants by a distinguished committee of scientists chaired by the editor-in-chief of Science magazine, Dr Donald Kennedy.   Waters announces expanded feature set in empower software It's not a new trend, just one that continues to gather momentum. And that is the effort by major analytical instrument suppliers to provide their customers with chromatography data management software that controls and acquires data from various brands of chromatographic instrumentation. Extending a trend that began in the late 80's with the support of the Agilent® 5890 Gas Chromatograph, Waters multi-vendor instrument control capabilities for its Empowerâ„¢ chromatography data software now include support for the Agilent 1100 Series Photodiode Array Detector. Managing data in a busy analytical laboratory is an ever-increasing challenge. This daunting task is compounded when labs use a mix of liquid chromatographs, gas chromatographs, photodiode array and mass spectrometry detectors from different suppliers, and whose scientists prefer to standardize on Waters software to run them. Waters Empower Chromatography Software, sold with Waters® brand UPLC and HPLC instrumentation, is a software tool that is more than meets the eye - it acquires data and controls the operation of and processes data from not only Waters brand instrumentation, but Agilent 1100 Series Photodiode Array Detectors, 1100 Series Liquid Chromatographs, and Agilent 5890 and 6890-series Gas Chromatographs. "There are quite a few CDS products, but they can't match the feature set of Empower including support for Agilent instrument control and data management," says Pat Martell, Director - Informatics Product Marketing at Waters Corporation. An early convert to this approach of laboratory data management is Johnson & Johnson. "Since Waters added the full control functionality for Agilent's 1100 LCs and 6890 GCs to its Millennium®/Empower product, we can again use all our chromatography instrumentation with a software package which is state-of-the-art for both productivity and compliance", says Pascal Maes, Global Analytical Development, Pharmaceutical R&D, Johnson & Johnson, Beerse, Belgium.   Praj launches new technology to produce fuel ethanol With increasing importance of fuel ethanol as petrol additive for reduction of transport fuel emissions, Praj Industries has launched a new technology for production of ethanol from sweet sorghum after an extensive R&D at laboratory and industrial levels. It launched the technology in Chennai recently. Praj has been conducting research into viable alternate feedstock for ethanol production at its R&D and Engineering Center in Pune. "Fuel ethanol has been accepted globally as one of the ways of reducing environmental pollution. We are glad to be at the forefront of this movement. Today, Praj has customers all over the world. We will continue to take the company forward through innovation and knowledge that lead to Future Perfect technologies," said Pramod Chaudhari, chairman, Praj Industries Ltd. " Innovation has been the cornerstone of Praj. Our R&D facilities called Matrix â€“ The Innovation Center was expanded in 2002 to focus on more productive processes and energy crops for fuel ethanol production. The findings we share with our customers are a result of this body of work. We are very proud that the Government of Tamil Nadu is encouraging sweet sorghum to ethanol production program," he said. After cultivating sweet sorghum based on various seeds in different regions of India, Praj has successfully identified appropriate varieties of seeds and cultivation practices which will lead to maximum ethanol yields in different environments. Praj will shortly commence coordination of regular supply of these seed varieties to ensure higher yields. "We have achieved sweet sorghum (stalk) yields as high as 20 tons/acre in just 3.5 months having sugar content in excess of 10.5 percent," said Pramod Chaudhari.         ]]> <![CDATA["The Indian Continent Shows the Highest Growth Rate."]]> https://biospectrumindia.com/news/95/1588/the-indian-continent-shows-the-highest-growth-rate-.html https://biospectrumindia.com/news/95/1588/the-indian-continent-shows-the-highest-growth-rate-.html Thu, 16 Dec 2004 13:15:00 +0530 "The Indian Continent Shows the Highest Growth Rate." Nils Kan, European sales director, Corning Life Sciences Division Corning produces one of the most comprehensive lines of scientific laboratory products for life science research. Nils Kan, European sales director, Corning Life Sciences Division, was in India recently. He shared his views about the potential of the Indian subcontinent in this area. How do you perceive the global and the Indian life sciences industry? The existing life sciences industry is very healthy. The numbers in the US and Europe show a moderate growth. There is a lot of consolidation happening in the pharma and biotechnology industry. The Indian continent shows a higher growth rate than the rest of the world. This is very appealing fact. India, over the last couple of years, has evolved as a very solid biotech and pharma market. Initially known for generics, India is now rapidly moving into vaccine manufacturing. I think over the next five years, India is going to be a power to reckon with in the life sciences market. All the signals that we are getting from the scientists and the industry are very positive. India is poised for great things in the biotech market. China is also an important country in this region due to the sheer magnitude of the size and its work force is another hot spot. However, as far as life science market is concerned, China is trailing India. With time China is going to be another big hub. Life Science is an important segment for Corning. Why is it so and what is the overall focus? The guiding philosophy of Corning is to be at the forefront and a market leader in the various sectors it deals with. The life sciences division is one of the divisions of Corning Inc. We are into technology driven manufacturing with revenues well over $3.5 billion. Corning is an industry leader in segments such as optical fibers, liquid crystal display, environmental and of course life sciences products. We have a lot of core competencies. Some of them are process engineering, biochemistry, surface modification, plastic and glass manufacturing. The beauty of Corning is that we can combine technology from our different divisions and create a product. In the life sciences segment, we have a bright future ahead and are projecting to grow by about three or four times over the next couple of years. Corning is investing heavily in the life sciences division. About 10-11 percent of our revenues are reinvested into research and development. This shows our focus and commitment towards fundamental and applied research. How did the tie-up between Corning and Axygen happen? Corning has been present in India in an unstructured manner during the last couple of years. Since India is being regarded as a hot spot in life sciences, we decided to have a more structured and focused approach in the Indian life sciences market. We have been looking for a reliable partner with good market coverage and found that partner in Axygen, which has a good reputation in the market place. All the customers that I have visited are happy about the commercial staff and dealer network of Axygen. And Axygen will promote our cell culture and liquid handling brands. Rolly Dureha, New Delhi ]]> <![CDATA[Delhi University researchers unveil clean leather processing technology]]> https://biospectrumindia.com/news/95/5130/delhi-university-researchers-unveil-clean-leather-processing-technology.html https://biospectrumindia.com/news/95/5130/delhi-university-researchers-unveil-clean-leather-processing-technology.html Thu, 16 Dec 2004 13:10:00 +0530 Researchers working at the department of microbiology, Delhi University, South Campus, have developed an enzyme-mediated leather processing technology, which is claimed to be environment friendly and does not compromise on the final quality of the leather. The researchers have demonstrated the removal of hairs from skin (dehairing) in just 6-8 hours. The complete hair comes out from the hair follicle, which can be used as a byproduct by the tanners. And the flesh removed (defleshing) from the skin can be exploited for the extraction of dehydroxy amino acids and the left over can be used for manure making or for animal feed improvement. This research work is part of a three-year project conceived under the New Millennium Indian Technology Leadership Initiative (NMITLI) scheme aiming at the ambient preservation of leather, its processing and the waste treatment. Leather processing in India is one of the oldest technologies. Shoe making was in fact pioneered in India. And many tanneries were established. Conventionally, leather processing is done by strong chemicals leading to the production of toxic byproducts. Realizing the pollution problem in recent years, many tanneries have been closed due to the hazardous effluents produced. Since India is the second largest in leather processing after Brazil, there has been a long felt need to develop an alternate procedure, which is least polluting, economically viable with no compromise on quality. And this was an important mandate of the project under the NIMITLI scheme. Dr T Ramasami, director, Central Leather Research Institute (CLRI), heads the project. Twelve coordinated groups including the Pune University, Agarkar Research Institute, National Chemical Laboratories, Madurai Kamaraj University, Centre for Cellular and Molecular Biology, Department of Microbiology, South Campus, Delhi University have been working on different aspects of the project. The first phase of the project has been completed successfully. The microbiology department of Delhi University was involved in the enzyme mediated leather processing aspect of the project. The researchers did the initial screening of organisms, isolated the suitable microbe, studied its biological properties and characterized it. Then they developed the technology for its mass production and scale up processes. Dr RK Saxena, head, department of microbiology, University of Delhi, observed, "If we are able to provide a viable, environment friendly technology to the tanneries in Chennai, Kolkata, Kanpur and in the extreme North then the turnover of processed leather can be increased greatly in the country." A chip hotline for medical emergencies Two US-based companies have developed the world's first implantable microchip for human use. The sub-dermally implanted Radio Frequency Identification Device (RFID) has been christened "VeriChip". Each chip is about the size of a grain of rice and contains a unique 16-digit verification number that is captured by briefly passing a scanner over the insertion site. This identification number could open the medical details of the person stored in a central database According to the chipmakers, the recommended location of the microchip is in the triceps area between the elbow and the shoulder of the right arm and the brief outpatient "chipping" procedure lasts just a few minutes involving local anesthetic followed by quick, painless insertion of the chip. Once inserted just under the skin, the VeriChip cannot be seen by the human eye. A small amount of radio frequency energy passes from the scanner energizes the dormant chip, which then emits a radio frequency signal transmitting the verification number. The captured 16 digit number links medical details of the person stored in a central database via encrypted Internet access. Recognizing the importance of such a facility during an emergency, the chip has been approved by the US FDA for medical use in the US. But at the same time the chip could open a critical window for radio tracking humans and has the potential to replace passports, ID cards and even credit cards. New tool reveals molecular signature of cancer and HIV Scientists have designed a new molecular tool, LigAmp, to pinpoint DNA mutations among thousands of cells, the equivalent of searching for a single typo in an entire library of books. Preliminary studies in a small number of cell lines and body fluids show the ultra-sensitive test may help detect microscopic cancer and HIV drug resistance. "Other molecular tests make it very difficult to locate a mutation in a particular cell surrounded by thousands of other cells that don't have the mutation," said James Eshleman, who led the study with colleagues from the Johns Hopkins Department of Pathology and Kimmel Cancer Center. "LigAmp essentially filters background 'noise' caused by normal cells and reveals specific mutations." The researchers say that sensitive tests to locate mutations could identify cancer in patients at high-risk for the disease. Such tests could even help detect a recurrence of cancer by monitoring whether the number of mutations rises above a predetermined threshold value. In addition to cancer detection, the Hopkins mutation-finder appears able to detect drug-resistant HIV. The team tested it on blood samples from a handful of patients with HIV and located DNA mistakes in the virus itself that make it resistant to certain antiretroviral drugs. Results of analyses of the new test were published in the November issue of Nature Methods. "We designed LigAmp to improve how we look for extremely subtle variations in viral and cellular DNA," says Eshleman, an associate professor of pathology and oncology and associate director for the DNA Diagnostics Laboratory at Johns Hopkins. "The molecular code of normal cells may look identical to cancerous except for a single rung in the DNA ladder-structure." The test works by creating a molecular "magnet" with an affinity for the DNA mistake, also known as a point mutation. If the mutation is found, the magnet binds to it and inserts a bacterial gene. The bacterial gene serves as a red flag and produces a fluorescent color visible to powerful computer programs. In their studies, the Hopkins investigators tested LigAmp on colon cancer cell lines, blood from HIV patients, and fluid from cancer patients' pancreatic ducts. Single mutations in colon cancer cells and drug-resistant HIV viruses were detected at dilutions of up to 1 in 10,000 molecules. Further analysis of LigAmp with larger sample sizes and blinded panels of clinical samples currently is under way. Bovine genome assembled The first draft of the bovine genome sequence has been deposited into free public databases for use by biomedical and agricultural researchers around the globe. Contributors to the $53 million international effort to sequence the genome of the cow (Bos taurus) include: the National Human Genome Research Institute (NHGRI), which is part of the National Institutes of Health (NIH); the US Department of Agriculture's Agricultural Research Service and Cooperative State Research, Education, and Extension Service; the state of Texas; Genome Canada through Genome British Columbia, The Commonwealth Scientific and Industrial Research Organization of Australia; Agritech Investments Ltd, Dairy Insight Inc. and AgResearch Ltd, all of New Zealand; the Kleberg Foundation; and the National, Texas and South Dakota Beef Check-off Funds. The Hereford cow and calf BETHESDA. The DNA of the Hereford cow, named L1 Dominette 01449, was sequenced. Photo courtesy: Michael MacNeil, USDA. A team led by Richard Gibbs at Baylor College of Medicine's Human Genome Sequencing Center in Houston carried out the sequencing and assembly of the genome. Additional work aimed at uncovering more detailed information about individual bovine genes-a process referred to as full-length cDNA sequencing-is being conducted by a team led by Marco Marra, at the British Columbia Cancer Agency in Vancouver. Researchers are continuing sequencing and plan to have a six-fold draft of the bovine genome completed sometime in the first half of 2005. They are also comparing the bovine genome sequence with those of the human and other organisms that have already been sequenced. Results of these analyses will begin to be published in the public databases in the next several months. Sequencing of the bovine genome began in December 2003. The breed of cattle selected for the bulk of the sequencing project was Hereford, which is used in beef production. Sequencing at lighter coverage will be carried out in additional cattle breeds, including the Holstein, Angus, Jersey, Limousin, Norwegian Red and Brahman. The competed Bovine Genome Sequencing Project will allow detailed tracking of the DNA differences between these breeds to assist discovery of traits for better meat and milk production and to model human disease. Living "Brain" invented A University of Florida scientist has grown a living "brain" that can fly a simulated plane, giving scientists a novel way to observe how brain cells function as a network. The "brain", a collection of 25,000 living neurons, or nerve cells, taken from a rat's brain and cultured inside a glass dish, gives scientists a unique real-time window into the brain at the cellular level. By watching the brain cells interact, scientists hope to understand what causes neural disorders such as epilepsy and to determine noninvasive ways to intervene. As living computers, they may someday be used to fly small unmanned airplanes or handle tasks that are dangerous for humans, such as search-and-rescue missions or bomb damage assessments. "We're interested in studying how brains compute," said Thomas DeMarse, the UF professor of biomedical engineering who designed the study. While computers are very fast at processing some kinds of information, they can't approach the flexibility of the human brain, DeMarse said. In particular, brains can easily make certain kinds of computations such as recognizing an unfamiliar piece of furniture as a table or a lamp that are very difficult to program into today's computers. "If we can extract the rules of how these neural networks are doing computations like pattern recognition, we can apply that to create novel computing systems," he said. DeMarse experimental "brain" interacts with an F-22 fighter jet flight simulator through a specially designed plate called a multi-electrode array and a common desktop computer. "It's essentially a dish with 60 electrodes arranged in a grid at the bottom," DeMarse said. "Over that we put the living cortical neurons from rats, which rapidly begin to reconnect themselves, forming a living neural network, a brain." Scientists find Nanowires capable of detecting individual viruses Harvard University scientists have found that ultra-thin silicon wires can be used to electrically detect the presence of single viruses, in real time, with near-perfect selectivity. These nanowire detectors can also differentiate among viruses with great precision, suggesting that the technique could be scaled up to create miniature arrays easily capable of sensing thousands of different viruses. The work was reported in the recent issue of the Proceedings of the National Academy of Sciences. This prototype biochip contains nanowire transistors that can detect the presence of individual viruses. The tubes carry fluid samples to and from the chip. "Viruses are among the most important causes of human disease and are of increasing concern as possible agents of biowarfare and bioterrorism," said author Charles M Lieber, Mark Hyman Jr., professor of chemistry in Harvard's Faculty of Arts and Sciences. "Our work shows that nanoscale silicon wires can be configured as ultra-sensitive detectors that turn on or off in the presence of a single virus. The capabilities of nanowire detectors, which could be fashioned into arrays capable of detecting literally thousands of different viruses, could usher in a new era for diagnostics, biosafety, and response to viral outbreaks." Lieber and his colleagues merged nanowires conducting a small current with antibody receptors for certain key domains of viruses such as agglutinin in the influenza-A virus. When an individual virus came into contact with a receptor, it sparked a momentary, telltale change in conductance that gave a clear indication of the virus's presence. Simultaneous electrical and optical measurements using fluorescently labeled influenza-A confirmed that these conductance changes corresponded to binding and unbinding of single viruses from nanowire devices. In addition to influenza A, the Lieber group tested nanowire arrays outfitted with receptors specific to paramyxovirus and adenovirus. The researchers found the detectors could differentiate among the three viruses both because of the specific receptors used to snag them and because each virus binds to its receptor for a characteristic length of time before dislodging-leaving only a minuscule risk of a false positive reading. "The fact that a nanowire array can detect a single virus means that this technology is the ultimate in sensitivity," Lieber said. "Our results also show that these devices are able to distinguish among viruses with nearly perfect selectivity." Lieber's co-authors are Fernando Patolsky, Gengfeng Zheng, Oliver Hayden, Melike Lakadamyali, and Xiaowei Zhuang, all of Harvard's departments of chemistry and chemical biology, physics, and division of engineering and applied Sciences. The work was supported by the Defense Advanced Research Projects Agency, National Cancer Institute, Ellison Medical Foundation, Office of Naval Research, and Searle Scholar Program. Source: Lieber Group, Harvard University Case University engineers develops sliver-sensor Miklos Gratzl, an associate professor of biomedical engineering and researcher at the Case School of Engineering, has developed for the first time a "sliver-sensor", a fully functional, minimally invasive, microscopic new monitor that can be placed just under the skin and seen with the naked eye for very accurate, continuous examination of glucose level for diabetics and other bodily fluid levels with the help of simple color changes. Colors in the tiny sensor, which is smaller than the tip of a pencil, gradually change from orange (low glucose levels) to green and then to dark blue as levels increase. A deep, darker blue signifies the highest glucose level that can occur in diabetics. Gratzl and co-principal investigator Koji Tohda, a biomedical engineering researcher at Case, believe the implications for improving the quality of life of diabetics would be substantial. "Many diabetics could greatly benefit from this technology, freeing them from having to take samples from their fingers several times a day to monitor blood sugar levels," Gratzl said. "The monitor could also help doctors with close monitoring of electrolytes, metabolites and other vital biochemicals in the body, primarily those of critically ill patients." Gratzl and Tohda's research also may benefit future astronauts. The research is being funded by NASA and the John Glenn Biomedical Engineering Consortium at NASA Glenn Research Center and partially by Vision Sensors LLC, a Cleveland-based start-up. Tohda's expertise in the area of optode technology helped point the researchers in the direction of using color changing molecules to detect ionic levels as they vary with changes in glucose. The sensor, which is one to two millimeters long and 100 to 200 micrometers wide, penetrates the skin easily and painlessly so users may insert or reinsert it themselves when needed and can be operational at least for several days at a time. It can be monitored by eyesight and by electronic telemetry. ]]> <![CDATA[Dr Kalam inaugurates NPIL]]> https://biospectrumindia.com/news/95/1247/dr-kalam-inaugurates-npil.html https://biospectrumindia.com/news/95/1247/dr-kalam-inaugurates-npil.html Thu, 16 Dec 2004 13:03:00 +0530 Dr Kalam inaugurates NPIL's state-of-the-art R&D facility Seen in picture from (L-R) are Mrinalini Sarabhai, Mallika Sarabhai (dancers from Darpana), Dr Swati Piramal, director, Nicholas Piramal India Ltd and Dr APJ Abdul Kalam, President of India. Dr APJ Abdul Kalam, President of India inaugurated the high-tech and most modern research and development facility of Nicholas Piramal India Ltd - "Nicholas Piramal Research Centre (NPRC)". Constructed within a year and at an investment of Rs 100 crore, the 300,000-sq.ft, the NPRC contains the state-of-the-art technology, designed to focus on discovery research and drug development by over 400 scientists. This research center will specialize in three critical areas such as development of anti cancer drug, inflammation inhibitor and drug for type 2 diabetes by overcoming insulin resistance. Some of the strengths of the NPRC include housing a unique collection of over 50,000 strains and 3000 plant species reflecting India's biodiversity, medicinal chemistry, molecular biology, toxicology, formulation research, new drug delivery systems, phytomedicines, natural products chemistry and chemical process development. Also present will be a strong patent cell that will assist scientists in establishing intellectual property. The activities of the company are multicentric and all the functions undertake independent as well as collaborative research projects in their areas of expertise. Internal core teams guide the activities of the research functions with inputs from external consultants â€“ both national and international. "India should become a working partner in proteomics project of gene characterization" "India missed the great opportunity in partnering the human genome project and thereby lost the utility of tremendous data. Now the Indian biomedical community has to take up the initiative to become a working partner in the proteomics project of gene characterization, "noted Dr APJ Abdul Kalam, President of India. Speaking after inaugurating the Nicholas Piramal Research Centre in Mumbai, Dr Kalam said, " Department of Biotechnology in partnership with R&D, academia and industry has already launched a national program on proteomics. This should be pursued as a mission mode project. This will lead to our being invited to participate in the global proteomics program." Commenting on the WTO regime he observed that on January 1, 2005, the Indian pharmaceutical industry would face a challenge of demanding indigenous design of drugs, which will have a profound impact on global competitiveness and business viability. As India comes into compliance with the TRIPS protocol mandated by the WTO, a new IPR regime will be enacted that will extend patent protection to new product inventions. The new product patent regime will affect a sea change in the way Indian pharmaceutical companies think and do business. He further said, "We have biotechnology and information technology. When they converge, we get bioinformatics and the important science of proteomics emerged has revolutionized the drug design. Now with the emergence of nanotechnology we have an excellent opportunity to be a global leader in the development of drug delivery systems and medical diagnostics." "Information technology has become very relevant to areas like pharmaceutical research because of the enormous amount of data, which has to be mined and analyzed to arrive at definite conclusions. The results of proteomics program will unravel the genomic mystery leading to the bio-medical community to create a new evolutionary future for the human race. As the volume of data generated grows, so does the demand for faster data processing technologies. Thus, to arrive at some destination in the area of 'bio-informatics', it is very necessary to deploy powerful information and communication technologies so as to be able to get a hold on gene sequences, expressions, protein structure delineation and population genetics etc.," said Dr Kalam. Maharashtra observes third Biotechnology Day Amidst a change of guard in the government and festive mood, the government of Maharashtra was successful in organizing the third Maharashtra Biotechnology Day on November 10. Seen in picture (L-R) Banmali Agrawala, vice chairman, CII Maharashtra state, Dr SR Rao, adviser to Minister of Science & Technology & Ocean Development, Government of India, Dr Swati Piramal, director, Nicholas Piramal India Ltd, Vishwas Dhumal, principal secretary, Department of Industries, Government of Maharashtra and Virendra Gupta, Director, CII, Mumbai. "Based on the discussions with the industries, academicians, consumers, and agriculturists, the government of India would soon announce the National Biotech Policy. The policy would also look at avenues for public-private partnerships, " said Dr SR Rao, adviser to Minister of Science & Technology & Ocean Development, Government of India. Dr Rao further said, "the government is all geared up for public-private partnerships to solve the issue in the area of research and discovery and it is open to the views and suggestion in new partnerships and alliances, which would make India a leader in biotechnology industry and become globally competitive." Speaking at a conference to celebrate the third Maharashtra Biotechnology Day in Mumbai, he observed, "There is a need for networking, public-private partnership and alliances with achievable goals from time to time in the area of research and development". "In agriculture sector about 20 trangenics are at various stages of development. Bt cotton has been sublicensed to as many as 16 organizations. Even the big pharmaceutical companies like Nicholas Piramal, Panacea Biotech, Wockhardt, Zydus Cadila, have diversified their activities and investing on research and development in biotechnology space. Considering the potential in biotechnology, the Council for Scientific and Industrial Research labs are also working on many biotechnology products," he said. However, expressing concern he noted that the public sector labs are able to develop the products at pilot scale. Talking about the state government's initiative, Vishwas Dhumal, principal secretary, Department of Industries, Government of Maharashtra, said that the government is committed to the rapid growth of the biotech sector through public-private partnerships. He highlighted three key areas for the same. First, private sector, public hospitals and research institutes are being encouraged to work in the area of clinical trials. "The government has constituted an ethics committee to formulize the same", added Dhumal. Second, the government along with the Chatterjee Group has set up the International Biotechnology Park at Hinjwadi near Pune for biotechnology start-ups and thirdly, the government is actively promoting agri based biotechnology park at Jalna near Aurangabad, the seed capital of India. Dr Swati Piramal, director, Nicholas Piramal India Ltd, briefly explained the opportunities India had in clinical research, R&D, custom manufacturing over any other countries in the world. The costs of clinical trials in India are 40-60 percent lower compared to the developed world. She also briefed the challenges before Indian biotechnology industry when the patent regime comes into force from January 2005. Commenting on the Venture Capital funding Anand Dikshit, director, Rabo India, which is working closely with the government of Maharashtra for the development of the biotechnology in the state, said, "biotechnology is the future and government has to take the initiative in promoting and developing this industry." "The industry will receive about $100- 150 million in the next three years," he observed. To overcome the lack of skilled and pool of talents, which is the need of the hour for biotechnology industry, Dr Vidita Vaidya of Tata Institute of Fundamental Research (TIFR) suggested, "teaching at the research organizations. In this regard TIFR, a premier fundamental research organization and deemed university has already taken up an initiative. She also suggested for filling the gap that exits over the years between the industry and basic researchers/scientists. Other speakers who addressed the conference on the theme "Bio business opportunities in India" included Balaji Rao, director, TCG Urban Infrastructure Development Ltd, Vipul Mankand, president, SIDBI Venture Capital Ltd, Dr Kiran Marthak, VP-Medical Affairs & Clinical Research, GSK Pharmaceutical Ltd, Dr SPS Khanuja, director, Central Institute of Medicinal and Aromatic Plants, Dr SS Mahajani, Head of the Department of Pharmacology, Haffkine Institute, Dr Satish Bhatia, advisor, Clinical Operations & Quality, Ranbaxy Research Laboratories, Usha Thakur, corporate communications officer, SYGENIS Corporation, Dr M Vidyasagar, executive vice president, Advanced Technology Centre, Tata Consultancy Services. IKMC- 2004 meet stresses on bridging science and community The three-day International Knowledge Millennium Conference (IKMC 2004), held between October 31-November 2 in Hyderabad saw 15 speakers of repute from the US and 16 experts from India talking on technology transfer and entrepreneurship and building successful collaborations, processes and practices to achieve excellence in areas of industrial biotechnology, cell processing technology and metabolic engineering of medicinal plants. In his inaugural address, RA Mashelkar, director general, Council of Scientific and Industrial Research (CSIR), stated that the Indian biotech industry has touched a whopping $700 million and is growing at 39 percent. He added that the industry is undeterred by the myths engulfing the prospects and the Indian biotech industry is getting into strategic partnerships, making its foray into capital markets and evolving newer markets. Citing countries as Innovative Development Centers (IDCs), the indicators, Mashelkar said that India has got 31 scientific publications and 77 citations much ahead of countries like China, the US, UK, and Germany. He also noted that lot of innovative thinking is taking place among entrepreneurs and educational institutions. Highlighting the evolution of technology transfer practices in the new millennium, Stephen M Sammut, Venture Partner, Burrill & Company, remarked that the style of activity has changed tremendously. The Bay-Dole Act, a sponsored legislation that allowed universities rather than government ownership of government-funded research is now considered a successful piece of legislation after 25 years. Universities are also moving from academic administrators to experienced industry professionals. This can be seen as a great insight for venture capitalists, he asserted, and urged start-up of the venture capital firms. Joydeep Goswami, director, corporate development, head of licensing, Invitrogen Corporation, USA, said, "Commercializing innovation would benefit science, provide royalty, create further economic incentives for innovation, and fund additional research. Licensing can thereby enhance the benefits of commercialization by allowing institutions to maintain the focus on science, reducing costs by tapping the existing infrastructure and eventually improves the speed to market." He also laid stress on the key bottlenecks like lack of understanding of the market practices, business-product economics, customs and materials transfer, and suggested to implement single point accountability in terms of material transfer, flexibility in understanding partners point of view and quick turnaround of communications as few key best practices that can greatly improve the licensing process. Addressing the gathering, Kiran Mazumdar-Shaw, chairman and managing director, Biocon Ltd, said, "Being one of the three odd companies to have revenues in excess of $21 million, as of today seed capital was an important struggle for me. A lot of current day entrepreneurs also face that. Also, investing in research and intellectual property is very expensive." Dr Mani V Subramanian, group technology manager, Millipore Corporation, USA, speaking about the efficient bioprocess, said, "Numerous things right form scalability from a microtiter plate to recovery in various forms, and reproducibility of the process at the manufacturing level, needs to be taken care of. Equally, the process must be compliant, and yield consistent. Funding authorities are not kind to bioprocess research; the question always looms large on the priority of developing process technology ahead of the product candidate. Many bioprocess are developed with tight timeline, economics and regulatory constraints. Despite this, the bioprocess has enabled new biotherapeutics business to become a big industry at around $ 30 billion and is growing at 15 per cent. Dr J Sambasiva Rao, general manager, Novozymes South Asia Pvt. Ltd., India, presenting on enzymatic processing of Oils & Fats, said, "Enzymes help to improve quality, reduce cost and reduce waste in industrial processes. Industrial enzymes are the tools of nature meant to solve industrial problems replacing traditional chemicals, thereby improving quality and reducing cost of production. These biodegradable enzymes help to bring natural products to consumers creating a balance between business, environment and better lives. Various factors influence the manufacturing costs like process design and plant capacity, operating strategy, equipment and facilities costs, material costs and so on. Laying emphasis on various optimization strategies, Howard L Levine, Ph.D. BioProcess Technology Consultants, Inc., Acton, MA, concluded that increasing expression level decreases manufacturing cost and facility requirements. Intrinsic and extrinsic methods too help in increasing expression levels thus helping in process optimization. Earlier, during the valedictory session, Andhra Pradesh Chief Minister Dr Y S RajaShekara Reddy assured that the government would extend all possible support for the biotech companies to start up new ventures. He also urged venture capitalists and the foreign delegates to overlook the possibilities of exploring newer dimensions. M V Kamath, MD & CEO, ICICI Bank Ltd., in his welcome address stressed the fact that the presence of ICICI Knowledge Park in Hyderabad was not with an intention of making use of the cheaper resources but to reach out to the global requirements as a whole. Sunitha Natti, CyberMedia News, Hyderabad ]]> <![CDATA[Niche Pays]]> https://biospectrumindia.com/news/95/2051/niche-pays.html https://biospectrumindia.com/news/95/2051/niche-pays.html Thu, 16 Dec 2004 12:58:00 +0530 It is December and it is time for the second annual BioSpectrum Awards to honor the remarkable achievements of men and women who have contributed immensely to make Indian biotechnology an exciting area to watch. Every one of them has been chosen with immense care by a jury headed by the First "BioSpectrum Person of the Year" in 2003, Kiran Mazumdar-Shaw. Their remarkable success stories have been profiled in this issue. There is one thing that stands out: every one of them had identified a niche area and focused single mindedly to become the undisputed leader in that chosen sector. Whether it is Dr Manju Sharma's doggedness in pursuing the goal to make Indian biotech a sunshine sector, or Dr C S Poonawalla's obsession to make Serum the world's most sought after maker of pediatric vaccine or KK Narayanan's dream to make Metahelix India's best bioagri company, are all shining examples of niche play. As we celebrate their success stories, it is also an occasion to share with the readers the story behind the making of BioSpectrum, which itself is another example of the publishing company CyberMedia's focused approach to be the leader in disseminating information about India's knowledge industry and associated services. CyberMedia started in a small way in 1982 with the launch of Dataquest, India's first computer magazine. Dataquest the undisputed leader in that space since then. Today CyberMedia's other publications like PC Quest, Living Digital, DQ Week, Channels India and bpOrbit span the entire spectrum of knowledge sectors covering information technology, telecommunications, BPO and biotechnology. These are all marquee names and leaders in their respective segments. CyberMedia does not want to rest on its laurels. What better way that consolidate and also offer new products to fill the gaps that may emerge as Indians unleash their entrepreneurial spirit to expand the contours of the knowledge sector. To sustain these growth plans, CyberMedia has filed for an initial public offering (IPO) of 28.22 lakh equity shares aggregating to Rs 17 crore. The issue is expected to open in December 2004. The first-ever equity offer by the company will open to domestic investors and the shares are to be listed on NSE and BSE. CyberMedia had posted an annual turnover of Rs 58 crore for the financial year which ended in March 2004 with a profit after tax of Rs 3.7 crore. Between April and July this year, the revenues were to the tune of Rs 20 crore with a profit after tax of Rs 1.76 crore. The shares are expected to be offered within a price band of Rs 50-60 each. The niche play will continue as CyberMedia intends to use the IPO funds to launch two international publications--Global Outsourcing, a magazine that will reach out to international clients of BPO services and BioSpectrum's global edition from Singapore. With this CyberMedia will become the first Indian media house to launch global publications. CybeMedia has also sought the government's permission to launch BusinessWeek in India to help the information needs of the growing segment of Indian companies going global and provide an Indian perspective to global business trends. I have narrated the CyberMedia story here to drive home the message that being niche pays. Biotech entrepreneurs too should stick to their specialized field, reap the benefits of niche play, economies of scale and focused approach to knowledge generation. sureshn@cybermedia.co.in ]]> <![CDATA[It is not wise for Thailand to use GM tag for its Jasmine rice]]> https://biospectrumindia.com/news/95/2406/it-is-not-wise-for-thailand-to-use-gm-tag-for-its-jasmine-rice.html https://biospectrumindia.com/news/95/2406/it-is-not-wise-for-thailand-to-use-gm-tag-for-its-jasmine-rice.html Thu, 16 Dec 2004 12:56:00 +0530 Dr Suman Sahai The National Biotechnology Committee of Thailand plans to use GM technology to improve the quality and productivity of Jasmine rice, ordinary rice and rice for food processing. The plan for Jasmine rice is to use genetic engineering and molecular breeding to introduce resistance to flood and drought. This is not a wise move. Flood and drought tolerance can be more easily achieved by conventional breeding than by genetic engineering and the price for adding the GM tag may be too high. With the GM tag, Thailand would jeopardise the special status accorded to Jasmine rice. It would also risk its rice gene pools since the contamination of other rice varieties and their natural relatives with foreign genes from the GM Jasmine rice would be a certainty. Thailand has been fighting to protect its Jasmine rice from biopiracy. It has contested claims by US based companies to use its name in a trademark violation called 'passing off' as 'Jasmati'. The Jasmine rice of Thailand, is claimed by the Thai as a special Thai product and the Thai have sought to exercise their rights over this product invoking the IPR protection called 'Geographically Indicated (GI) Rights, in the WTO. Provided in Articles 22, 23 and 24 of the TRIPs chapter, GI protection can be claimed by countries for products that are exclusively associated with their region. At present, GI protection is available only for wines like Champagne and Spirits like Scotch whiskey. Developing countries are, however, fighting hard to increase the scope of GI protection so that products of interest to them can also be given GI IPR protection and be considered exclusively theirs. India for example has an interest in Basmati rice and Darjeeling tea, to name just two products. Thailand has claimed Jasmine rice as its own. Once Jasmine rice becomes a GM variety, not only is Thailand likely to lose its markets in those countries (particularly Europe) that are not favourably inclined to GM food, it will also forfeit its claim to GI protection. Is it willing to do that? Have the Thai authorities thought through the consequences of turning their premium Jasmine rice into a controversial GM food? The Thai thinking is probably like India's, which has invested in Bt Basmati. The Basmati project in India has been put on hold after protests from rice traders and groups like Gene Campaign which has pointed out that Basmati would acquire an 'untouchable' status if it were tainted with the GM label. The intention is to increase production of a premium product like Basmati or Jasmine rice and thus increase earnings in an assured high-end market. This will backfire because consumers will shy away from the GM label. Jasmine rice is not the food of the masses. It is an expensive premium product, much like India's Basmati rice. The poor, who cannot afford its high price, consume neither, so there is no pressure to increase its production from the point of view of food security. Like truffles and caviar, Jasmine rice is a luxury food, which brings good revenue for its farmers. Tampering with it by adding the GM label is likely to jeopardise the assured earnings of the farmers who grow Jasmine rice. Apart from the issue of special protection under GI , in WTO/TRIPs, is the question of environmental safety . Thailand belongs to the Indochina Centre of biological diversity. It has a great deal of diversity in rice, which includes farmer varieties, landraces and wild relatives of rice. One of the principle environmental concerns with respect to GM crops is the matter of gene flow and its consequences for agro-biodiversity. It is a fact of biology that pollen will fly around and along with pollen will fly around the foreign genes contained in the pollen of the GM crop. When there are other rice varieties and wild relatives in the vicinity, the pollen with foreign genes can cross pollinate with them, thus transferring the foreign genes to them . Although rice is largely a self-pollinated crop, high enough rates of cross-pollination have been recorded to cause concern for genes to be transferred from the GM Jasmine rice to the neighbouring rice varieties and the natural rice gene pool. We do not know yet what the long term consequences of such gene transfer and gene introgression can be since no studies have been done under developing country conditions. Western nations have done gene transfer studies on crops of interest to them but developing countries have not done enough of this kind of basic work. If there is no impact in the long term or the impact is harmless, it does not matter. But should we discover that there is a negative impact, we would have possibly jeopardised the integrity of one of the most important gene pools in the world. The consequences for food security could be unimaginable if the rice gene bank in nature were to be endangered. The implementation of GM technology is meant to be guided by the Precautionary Principle. This Principle was formulated because we know so little about the long-term impact of cultivating GM crops. The Precautionary Principle says that if we do not know enough or if there is uncertainty about the safety of a process or product, then it is best to avoid that product. We know practically nothing about the behaviour of GM rice in a natural agricultural environment, particularly in a centre of diversity. The precautionary principle dictates that we do not take a chance. In my view, no nation should cultivate a GM crop for which it is a centre of diversity. Mexico has taken this intelligent decision. Since 1998, the Mexican government has placed a ban on the cultivation of GM corn since Mexico is a centre of origin and diversity for corn. In 2002, the Mexicans went a step further; they banned even research on GM corn, since they were not prepared to take a risk with their corn gene pool. China does not allow the cultivation of GM soybean for which it is a centre of origin and diversity. Thailand and India should learn from these countries and leave GM rice alone. Dr Suman Sahai has a Ph.D in Genetics and has several years of research and teaching experience in the Universities of Alberta, Chicago and Heidelberg. Dr Sahai is a member of several national policy forums on environment, biotechnology and Intellectual Property Rights as well as education and health. She is also the convenor of Gene Campaign, New Delhi. Suman Sahai can be reached at: genecamp@vsnl.com www.genecampaign.org ]]> <![CDATA[At last, a New Year and a New Biotech Policy!]]> https://biospectrumindia.com/news/95/1593/at-last-a-new-year-and-a-new-biotech-policy.html https://biospectrumindia.com/news/95/1593/at-last-a-new-year-and-a-new-biotech-policy.html Thu, 16 Dec 2004 12:55:00 +0530 Dr. Shanthu Shantharam At the outset, mighty congratulations are in order for the Union Minister of Science and Technology and Union Secretary of Biotechnology for putting together a task force to draft a critically needed national biotechnology policy. It was really unfortunate that the previous leadership at the Department of Biotechnology (DBT) never saw the need for such a policy even when the rest of the stakeholders in the nation's biotechnology development craved for one. No time must be lost by the task force to get down to work right earnestly. But, one cannot help but wonder how any task force can whip out a draft policy document in three months. For a monumental job like drafting a technology policy document for a country like India, one would need at least a year. This time, it must be done right and there should not be any hurry. After all, the DBT ran without a policy for more than a decade. What is one more year! There has been huge cry for public participation in formulating the biotechnology policy and for a good reason. Biotechnology today is caught in a global whirlwind of controversies and emotional debates. Public acceptance of biotechnology will be the litmus test of any sound technology policy, and this taskforce must ensure it steadfastly. In order to ensure a meaningful public participation, it is necessary that the task force hold town hall style meetings (public hearings) in atleast half a dozen centers in the country and pro actively seek inputs by opening an interactive website for this purpose. The website must be updated daily and all the deliberations must be posted to make it completely transparent. In the end, the DRAFT policy must be posted for public comment for a finite period of time before finalizing it. All of this will take time and cannot be done in three months. The composition of the task force as it stands has very many eminent names and all of them are known to be extremely busy, and remains to be seen how much of quality time they can devote to this exercise in the next three months. The only way for them to do it is to devote their time fully to the task to the exclusion of other responsibilities. Is that realistically possible? In any case, it is important for this task force to pay attention to some of the burning issues of biotechnology. The number one issue is the biotechnology regulatory policy. The task force has to push for an independent statutory regulatory body. DBT must completely get out of regulating any aspect of biotechnology as it is an agency that is in the business of promoting biotechnology to avoid even the appearance of a conflict of interest. The second issue is technology development policy to promote public-private sector partnership and private investment in biotechnology development. Adjutant to the second issue is the policy on IPR in the context of WTO compliance. A pragmatic policy on IPR (Intellectual Property Rights) is the one in which there is a good measure of protection for really innovative and novel researches combined with benefit sharing commensurate with the amount of indigenous and traditional knowledge utilized. There must be a better way than what US or EU policies are on IPR. Third issue must be to tackle is the appalling standards of biotechnology education in the country. What is going on out there in the name of biotechnology education is a farce, and it must be set right forthwith. A biotechnology education council is one way in which to establish minimum standards for college level biotechnology education and curriculum. This council must be empowered to give accreditation to biotechnology programs and it must do away with undergraduate education in biotechnology altogether. Perhaps, it is the time now to review the performance of various biotechnology taskforces that have dispensed research grants in the country as long as DBT has existed. The entire peer review system needs overhauling to ensure only high quality proposals get funded and only priority areas identified. Perhaps, it is also time to scrap the overseas science advisory committee of DBT whose contributions to the developmental biotechnology in the country is questionable. Because biotechnology is at the center of very many societal controversies, it is crucial that study section on social, ethical, legal and economic impacts of biotechnology be instituted. It would have been really beneficial if the biotech policy taskforce included a couple of social scientists. To support the biotechnology regulatory oversight body, it is equally important to set up a new study section on biotech risk assessment research on an ongoing basis. Three main task forces to cover agricultural, biomedical and environmental biotechnology should be considered as permanent pillars for future biotechnology policy development. No technology policy can be rigid much less biotechnology as it is a rapidly evolving field. One should be happy if a current policy regime can cover it for about ten years. A sound technology policy formulation supported by a proper infrastructure can be dearly costly. But, that is the only way to do it right. Happy New Year! ]]> <![CDATA[Pennsylvania biosciences community starts Janney Pennsylvania Bio Index]]> https://biospectrumindia.com/news/95/7917/pennsylvania-biosciences-community-starts-janney-pennsylvania-bio-index.html https://biospectrumindia.com/news/95/7917/pennsylvania-biosciences-community-starts-janney-pennsylvania-bio-index.html Thu, 16 Dec 2004 12:50:00 +0530 The us Pennsylvania biosciences community starts Janney Pennsylvania Bio Index The Pennsylvania biosciences community has started an index that will appear on the Pennsylvania Bio website, www.pennsylvaniabio.org. Pennsylvania Bio joined with Janney Montgomery Scott to create this index to track the performance of its publicly traded companies and to draw further attention to the success of Pennsylvania biosciences community. Pennsylvania has a vibrant and growing biosciences industry in the commonwealth. According to some analysts the Life Sciences sector revenues could reach $200 billion by 2010. The Commonwealth of Pennsylvania has made a major strategic investment in developing and attracting new Life Science companies and, once they are incepted, to continue to grow them. This Life Sciences activity is predicated on research carried out at the state's major universities and other institutions. For the purpose of this growth, the Commonwealth has pledged and continues to invest $2 billion in its life sciences enterprise. That leadership is demonstrated further by the fact that Philadelphia was chosen to host the BIO2005. Pennsylvania is the second largest biopharmaceutical state in the US and has the largest concentration of tissue engineering firms in the nation. In fact, about 12 percent of the US biotech companies reside in the state, totaling over 160 biotech companies and 158 laboratories. According to a report during BIO 2004, Pennsylvania's bioscience industry is growing strong with 83,860 jobs in the industry and an average employee salary of $65,060. Some 2,038 businesses are part of the Keystone State's bioscience and bioscience-related industries, and these companies pay a total of $5.5 billion in total wages. Companies in the bio-pharmaceutical sector, which are engaged in the research, discovery and development of therapies, reported that the employment grew over 5 percent in 2002 to 27,121 employees. Further, Pennsylvania is home to 330 companies in the medical device and diagnostic sector, employing 18,024 Pennsylvanians and providing total annual wages of $808 million. The report also details venture capital investment from 2001 through the first quarter of 2004. The VC investment began to rise between 2002 and 2003, and the first quarter of 2004 showed a marked upswing in investments in Pennsylvania bioscience companies with more than $150 million going to the community. The main reasons for the growth has been due to strong policy leadership and creation of programs that support the growth of this industry, most notably the Life Sciences Greenhouse Initiative, he adds. Economic Stimulus programs such as expanded research and development tax credits with tradability, New Pennsylvania Venture Guarantee, New PA Venture Capital Investment, Keystone Innovation Zones and Core Industries provide more than $450 million every year that will specifically benefit the entrepreneurial life sciences community. The Economic Stimulus Package, together with $2 billion plus Life Sciences Enterprise program focuses on meeting the needs of developing life sciences companies for capital. For fiscal year 2003, Pennsylvania ranked fourth in the nation for funding through the National Institutes of Health, receiving $1.3 billion in funding. Two Pennsylvania universities-University of Pennsylvania and University of Pittsburgh-ranked in the top 10 nationally for NIH funding. Source: http://www.pennsylvaniabio.org and http://www.inventpa.com "Singapore committed to developing biomedical sciences" Dr Beh Swan Gin, director of Biomedical Sciences Group, Singapore Economic Development Board Dr Beh Swan Gin, Director Biomedical Sciences Group, Singapore Economic Development Board What are the strengths of Singapore in biotech? Singapore's interest extends beyond biotechnology and includes pharmaceuticals, medical technology and healthcare services. As such, we use the term "Biomedical Sciences" (BMS) instead. In our view, Singapore's strengths include the availability of top-class scientific talent, our culture for innovation, the presence of leading biomedical companies from all over the world, our strategic location providing easy access to key markets in Asia, and the strong regime for intellectual property rights protection. We also work hard to ensure that the industry is provided with state-of-the-art infrastructure. For research, the S$500-million Biopolis is a good example of our commitment. It is an integrated R&D complex with two million sq.feet of space that houses BMRC's five research institutes as well as R&D laboratories of numerous pharmaceutical and biotechnology companies. Opened in October 2003, the Biopolis also offers ready-fitted laboratory space for start-ups as well as laboratory support services specifically tailored for BMS companies. In addition, tenants will be able to tap on shared facilities such as mass spectrometry, DNA sequencing, library, auditorium, meeting rooms and lifestyle amenities. About 90% of the space in Biopolis has been taken up and Phase 2 of Biopolis is expected to be launched in early 2005. Apart from the Biopolis, the 183-hectare Tuas Biomedical Park also plays an instrumental role in attracting global biomedical companies to set up their manufacturing bases in Singapore. An additional 188 hectares will be developed as Park II to cater to the strong international interest. The Tuas Biomedical Park is located in close proximity to the manufacturing hub of Jurong Industrial Estate. What are the schemes on offer to this industry? Companies in Singapore enjoy a low corporate tax rate of 22 percent and this will be further reduced to 20 percent in 1-2 years. Depending on the project, EDB BMSG is also prepared to consider providing tax incentives such as the Pioneer status, which provides for full corporate tax exemption for upto 10 years. This incentive support is similar to that available for other industries. In addition, EDB's Bio*One Capital manages S$1 billion in several funds to invest in overseas or local biomedical companies with economic spin-offs to Singapore. Bio*One also has a BMS Innovate 'N' Create (INC) Scheme to provide seed capital for start-ups. What is the size of the BMS industry in Singapore? In 2003, the BMS industry's manufacturing output reached S$11.3 billion, a 15.9 per cent increase over 2002. The pharmaceutical sector contributed S$9.5 billion or 84 per cent of the total with the rest coming from medical device and equipment production. Employment in the biomedical sciences cluster also exceeded 7,500 in 2003. Singapore's biomedical manufacturing output has almost doubled since 2000, the year we started our BMS effort. We are well on our way of hitting our target of S$12 billion in manufacturing by 2005. In fact, we should reach this target this year. Leading BMS players with manufacturing presence in Singapore include Applied Biosystems, Aventis, Baxter, Becton Dickinson, Ciba Vision, GlaxoSmithKline, Kaneka, Merck, Novartis, Pfizer, Schering-Plough, Siemens Medical and Wyeth. In R&D, the companies include Eli Lilly, ESI, GlaxoSmithKline, Merlion Pharma, Novartis, Paradigm Therapeutics, PharmaLogicals Research, S*Bio, Viacell, and Qugen. Which are the key investment opportunities? Biomedical companies in Singapore undertake activities across the entire value chain, from basic research, drug discovery and product development, clinical trials, process development and manufacturing, to healthcare delivery. The community is very vibrant and investors will be able to find ample opportunities in many areas. For instance, Merlion and S*Bio are two very exciting drug discovery outfits based in Singapore, whilst ESI is one of the world leaders in stem cell research. In terms of public companies, Rockeby, Cygenics and Matrixview are some examples. They will soon be joined by Biosensors, which is a medical device company developing novel drug eluting stents. The Singapore government has committed approximately S$3 billion (US$1.7 billion) to develop the biomedical sciences sector. Slightly more than S$1 billion was allocated for funding public research. We have five world-class research institutes (mentioned above) that have made significant contributions to science and industry. For example, during the SARS crisis, GIS successfully sequenced the SARS virus in just 2½ weeks. More importantly, this led to the development of a PCR-based SARS detection kit by Roche Diagnostics. Separately, IMCB worked with Genelabs Diagnostics to develop antibody-based tests for SARS including a rapid 15-minute Western Blot test kit and an Enzyme-linked Immu-nosorbent Assay (ELISA) test. What are the major hurdles? Talent is key to this industry. A*STAR is embarking on an aggressive program to attract more Singaporeans to pursue graduate studies locally as well as in top universities around the world. Since 2001, more then 400 people have received scholarships and fellowships to pursue biomedical sciences related studies. By year 2010, more than 1,000 Singaporean PhDs would be added to the research community. To complement the training of local Singaporeans, Singapore welcomes international talent from all around the world. It promotes a pro-foreign and pro-local policy. Good science, a cosmopolitan environment, and flexible immigration policies for professionals, attract such research talent to Singapore. Narayan Kulkarni in Mumbai europe Ireland leads Europe in life sciences Ireland is leading Europe in the life science research field, with the Irish Government investing E2.5bn in innovation and technology. This was told at a conference in London that was backed by Irish Government. Over the last decade, Ireland has seen a dramatic rise in both indigenous and foreign life science investment as 170 life science companies and 13 of the top 15 pharmaceutical companies now have significant bases in Ireland. The Irish Government, and agencies such as Enterprise Ireland, the Science Foundation Ireland and the Industrial Development Agency, are ensuring Ireland's ongoing success, including a commitment to invest E2.5bn in innovation and technology in the coming years. The conference also launched the UK's first all Irish scientific network, TechLink UK - Ireland designed to assist Irish networking in the UK. Dr Peter Fearon, Chair of the new group said that, until recently, the UK-based Irish scientific community has not felt the need to network in the UK. However, the opportunities in Ireland are now providing a catalyst for closer dialogue. Source: www.biotechnologyireland.com Austria's Biotech sector booms Austria boasts a thriving biotech sector, which is highly attractive to investors. The country's biotech industry profits from the commitment of both private investors as well as governmental incentives for high-tech projects. This development over the past few years can be attributed to effective technology promotion measures resulting from the close cooperation between the business and scientific communities. "Investors and researchers are aware that they can rely on Austria. The government has recognized R&D to be one of its main future-oriented priorities, which will particularly benefit biotechnologies," says Werner Lanthaler, CFO of Intercell AG, a Vienna-based biotech firm manufacturing so-called "smart vaccines" designed to combat infectious diseases and malignant tumours. In the year 2004, a total of 5.27 billion Euros will be invested in R&D in Austria, which represents a 2.97 percent share of the nation's gross domestic product. This means that Austria's gross domestic R&D expenditures will surpass both the EU average of 1.93 percent (Source: Austrian Statistical Office, 2004) and Germany's national R&D quota of 2.52 percent (Source: National Research Report 2004). Austria's R&D drive is focusing on promoting life sciences as well as information and communication technologies, nanotechnology, mobility and transport, as well as environmental protection and energy projects. The pharmaceutical and biotechnology sectors in Austria invested approx. 370 million Euros in their R&D activities in 2003. An additional 110 million Euro was committed to new research facilities (Source: Austrian Federal Chamber of Commerce, 2003). In the years 2002 and 2003, large-scale investments in Austria as a business location were made by Baxter, (205 million Euro), Boehringer Ingelheim (60 million), Ebewe (8 million), Sandoz (168 million) and Sanochemia (3 million). Partnerships among several academic and/or business partners are promoted within the framework of the national genome research program called "GEN-AU." 10.5 million Euros in funding is available each year for this program, which supports projects in the fields of proteomics (analysis of protein molecules) and cancer therapy, to give just two examples. Life Science Austria, a program developed by the Federal Ministry of Economic Affairs, initiates and provides support for academic spin-offs and start-ups in the biotechnology sector. Biotech centers have emerged in Innsbruck (Tyrol), Graz (Styria), Krems (Lower Austria) and in the province of Burgenland, which all complement Vienna, the country's leading biotech hub. In particular, Life Science Austria supports the patenting of innovations and the commercial realization of biotech projects. The Vienna region already ranks among the top 15 EU regions (out of a total of 150) in terms of the number of biotechnology patents. Source: www.aba.gv.at EU Commission to ask members to lift GM bans The EU Commission will ask a number of its member states to lift their bans on certain EU approved GM products at the Regulatory Committee meeting in Brussels. Five member states (1) have national bans on 5 EU-approved biotech crops. These bans were imposed using the safeguard clause of Directive 90/220 that permits such bans if there are real safety concerns, but that also requires that new scientific information be provided to support such bans. In July 2004, the European Food Safety Authority reinforced earlier opinions by the European Commission's Scientific Committee and confirmed that these various national bans were not scientifically justified (2) â€“ there is no information to support their claims that these products are unsafe. "The fact of the matter is that the EU's Food Safety Authority has rejected all of the "new" information provided by these member states. They have no scientific basis to maintain their bans," says Simon Barber, Director of the Plant Biotechnology Unit at EuropaBio, the EU association for bioindustries. The Commission in its role as guardian of the treaty is upholding EU law by requesting these countries to withdraw their bans. Source: www.europabio.org ]]> <![CDATA[New biotech chief at FICCI]]> https://biospectrumindia.com/news/95/6784/new-biotech-chief-at-ficci.html https://biospectrumindia.com/news/95/6784/new-biotech-chief-at-ficci.html Thu, 16 Dec 2004 12:31:00 +0530 Vishal Gandhi is the new Associate Director, and Head-Biotechnology at the Federation of Indian Chambers of Commerce and Industry (FICCI). Born in 1976 in New Delhi, he did his masters in biotechnology from the University of Hyderabad. In his professional career of six years, he has worked in various capacities in the industry. Prior to this appointment, he was the senior research biotechnologist at Ranbaxy Research Laboratories, Gurgaon and research associate in Dabur's Oncology and Biotechnology Research Foundation. Currently he is the member of several working groups on National Policy for Biotechnology. He is also a member of the Indo-US high technology cooperation group. Nanavati of Paraxel joins the board of Suven Life Sciences Suven Life Sciences, a pioneer in CRAMS, has hired Nayan Nanavati, a senior executive of Paraxel Corp, USA, one of the key Contract Research Organizations of the world with annual revenue exceeding $ 650 million. In his most recent position as a vice president of pre and post-approval clinical research at Paraxel International, Nanavati was instrumental in conceptualizing and establishing a new business unit within its Clinical Research Services group. Under his leadership, Paraxel was successful in gaining a market leadership position in North America in a very short span of two years. Prior to his stint at Paraxel, Nanavati served in the pharmaceutical industry for 14 years. At Novo Nordisk Pharmaceutical Inc., USA, he served as a Head of Women's Healthcare Division for North America. During his tenure at Novo Nordisk, Nanavati and his team were successful in obtaining approvals for three new drugs for global marketing. Nanavati holds a Master of Science degree in Immunology from India, Master of Science degree in Medical Technology from University of Maryland and did his post-graduate work in infectious diseases Immunology at Johns Hopkins University Nanavati brings to Suven Life Sciences, two decades of cross border experience in the Life Sciences industry, and will be the President and COO of Suven Life Sciences USA LLC. He will be based in the USA, and will drive Global business development and sales for Suven. Suven Life Sciences USA LLC is playing a key role in showcasing the strengths of Suven Life Sciences, through its comprehensive lab facilities, and is currently targeting small and mid sized US biotech and pharma companies for marketing Suven's products. Obituary Sanjeeb Panda Passes Away The ever-smiling Sanjeeb Panda, the marketing face of BioSpectrum in the Northern Region since its launch is no more. He passed away at the All India Institute of Medical Sciences (AIIMS), New Delhi around midnight on Saturday, November 20. The death occurred due to brain haemorrhage. Sanjeeb was 30. Sanjeeb was suffering from a viral fever from November 15 and was on medication. His roommates rushed him to AIIMS when he experienced some paralytic attack. He slipped into coma at AIIMS and doctors diagnosed it to be a previously undetected tumor in the brain. Sanjeeb passed away around midnight. Sanjeeb's mortal remains were flown to his parent's home in Sambalpur, Orissa and the cremation took place on November 21. A B Tech in Mechanical Engineering, Sanjeeb joined BioSpectrum prior to its launch in November 2002. Due to his hard work, and affable nature which won him friends instantly, Sanjeeb emerged as the magazine's leading sales person in a very short time. Extremely well read and knowledgeable about diverse fields, Sanjeeb enthralled his colleagues and friends in debates and knowledge-sharing. The eldest of two siblings, Sanjeeb was the sole breadwinner for his family. His father recently retired from service and Sanjeeb was supporting his younger brother's education. He was the rare cricket buff who shunned television broadcasts to be able to spend more quality time with his friends. His small apartment in South Delhi was the abode of a wide circle of friends and relatives who trooped into Delhi to make a career in education and the booming BPO sector. Sanjeeb's passing away is a great loss to BioSpectrum, CyberMedia and the biotechnology sector. All Cyberites join his family in this hour of grief and pray for his soul to rest in peace. ]]> <![CDATA[BioTrends]]> https://biospectrumindia.com/news/95/1250/biotrends.html https://biospectrumindia.com/news/95/1250/biotrends.html Thu, 04 Nov 2004 18:13:00 +0530 Flu Vaccine Shortage Hits US "For years, we made fun of the former Soviet Union for the long queues to pick up perennially short essential items. How is the United States in 2004 any different," wrote an angry American in the New York Times, referring to the night long vigils and mad scramble and rationing for flu vaccines as the nation approached another winter. What is happening in the US? Evidently, the flu vaccine is in short supply in October. The government was forced to ration its supply with priority to infants, pregnant women and senior citizens. Flu vaccine supplies disappeared faster than it appeared at health clinics. A biotech major, Chiron Corporation had chartered an aggressive program for meeting the increased American need of influenza vaccines. But its production plans ran into rough weather after British regulators suspended the license for vaccine production due to contamination problems. And the US ran short of the influenza vaccine. On October 5, 2004, Chiron Corp. notified US government's Center for Disease Control (CDC) that none of its influenza vaccine (Fluvirin) would be available for distribution in the US for the 2004â€“05 influenza season. The company indicated that the Medicines and Healthcare Products Regulatory Agency (MHRA) in the United Kingdom, where Chiron's Fluvirin vaccine is produced, had suspended the company's license to manufacture Fluvirin vaccine in its Liverpool facility for three months, preventing any release of the vaccine for this influenza season. This action will reduce by approximately one half the expected supply of trivalent inactivated vaccine (flu shot) available in the US for the 2004â€“05 season. For sourcing flu shots this year, the US government had heavily relied on Chiron and Aventis, the two major suppliers of the influenza vaccine, but in the present scenario the US officials could widen their options for acquiring flu vaccine from additional suppliers next year or encourage other companies to enter the business, which could cut Chiron's market share in the future. The question: will Indian companies have an opportunity to tap the demand for flu vaccine? According to some people in the industry, there will be opportunities. But it is not that companies will increase their production. What is more important is that US and other countries may now look at more vendors for sourcing products and not just rely on a few companies. Chiron had pinned its hopes on its British factory, the erstwhile PowderJect Pharmaceuticals, which it acquired in July 2003 to expand its vaccine business. The company had aimed to double the vaccine production capacity of the plant, located in Liverpool from 26 million vaccine doses in 2002 to 50 million this year. But MHRA's decision has upset the availability of influenza virus vaccine in the US and the revenues of the company. MHRA asserted that Chiron's manufacturing process does not comply with UK Good Manufacturing Practices regulations. The remaining supply of influenza vaccine expected to be available in the US this season is nearly 58 million doses of Fluzone (inactivated flu shot) manufactured by Aventis Pasteur Inc. Of these doses, approximately 30 million doses have already been distributed by the manufacturer according to CDC. In addition, approximately 3 million doses of live attenuated influenza vaccine (LAIV/FluMist manufactured by MedImmune will be available this season. The CDC and its Advisory Committee for Immunization Practices (ACIP) is issuing interim recommendations for influenza vaccination during the 2004â€“05 season. These interim recommendations were formally recommended by ACIP on October 5, 2004. There are several stories doing the round. A plausible theory being attributed to this fiasco is pushing the nearly 25-year-old factory beyond its limits. The aging factory was just not able to handle the sudden spurt in its production capacity. But this theory is unfounded, feel the Chiron higher-ups, who claim that about $75 million had been spent to upgrade the factory in the last five years and the company was committed to spend another $100 million to replace a part of the plant. "We take our responsibility to protect human health very seriously," said Howard Pien, president and CEO of Chiron. "Chiron believes in the value of influenza vaccination, and we are committed to taking all necessary actions to ensure an adequate vaccine supply for the 2005-2006 influenza season," he added. The facility, located in Liverpool, was established in the 1970s and has passed through a series of owners and problems during the last decade. It is reported that Polio vaccines manufactured by Medeva, a previous owner, at the plant were recalled after the British enforcement agencies said they might be contaminated with Bovine Spongiform Encephalitis, or the mad cow disease. This entire episode could serve as a learning experience for the Indian biomanufacturing industry, which is aiming to be a global biotech-manufacturing hub. Today, India's USP is the speed and cost of R&D. Along with this we should also bear in mind that the quality of the product is equally important. As Kiran Mazumdar-Shaw, chairman and managing director, Biocon said, "Outsourcing is not all about the cost advantage but the quality of deliverables is also important. We should not compete on cost, but on the quality of deliverables". Ch. Srinivas Rao and Rolly Dureha ]]> <![CDATA[Human Genome Sciences announces agreement with]]> https://biospectrumindia.com/news/95/3015/human-genome-sciences-announces-agreement-with.html https://biospectrumindia.com/news/95/3015/human-genome-sciences-announces-agreement-with.html Thu, 04 Nov 2004 15:15:00 +0530 Under the agreement, Human Genome Sciences will receive an upfront fee and clinical development and commercial milestone payments worth $183 million. Further, Human Genome Sciences will also receive royalties on the annual net sales of any products developed and commercialized. Human Genome Sciences will be responsible for the manufacture of Albugon for Phase 1 and 2 clinical trials. Albugon was created using Human Genome Sciences' proprietary albumin fusion technology, which involves fusing the gene that expresses human albumin to the gene that expresses a therapeutically active protein. Research has shown that the fusion of therapeutic proteins to human albumin decreases clearance and prolongs half-life. Albugon results from the genetic fusion of human albumin and GLP-1. Abbott acquires Spine Next Abbott has announced the acquisition of Spine Next, SA, France, a privately owned manufacturer of orthopedic spinal implant devices. "This acquisition enhances our spinal product line with an exciting non-fusion technology and expands the established global distribution network for our existing spinal products business," said Jeffrey Binder, president, Spinal Concepts, a division of Abbott Laboratories. According to Richard A Gonzalez, president and chief operating officer, medical products group, Abbott this move is consistent with the company's overall strategy of focusing on high-growth, technology-driven areas. Under terms of the agreement, Abbott acquired all of the equity of Spine Next for approximately $60 million in cash plus additional milestone payments upon achievement of future targets. One-time charges are expected in the fourth quarter of 2004. Among Spine Next's products is the Wallis system, a spinal implant for treating the root cause of degenerative disc disease without fusing the spine. Dynamic stabilization devices treat degenerative disc disease by providing additional support to the spine without fusion of the vertebrae. They have the potential to be less invasive than artificial discs, and provide surgeons an option for treating degenerative disc disease earlier in its progression. Applied Biosystems, MDS transaction complete Applied Biosystems, an Applera Corp. business, and MDS announced the completion of the transaction to expand the scope of their joint venture in life science mass spectrometry. Under the terms of the transaction MDS will pay $40 million for a 50 percent interest in intellectual property assets related to current Applied Biosystems MALDI Time-of-Flight (TOF) mass spectrometry systems and next-generation products under development, together with a 100 percent interest in certain MALDI TOF product-related manufacturing and research and development assets. MDS and Applied Biosystems have each contributed the MALDI TOF through a 50:50 joint venture of Applied Biosystems and the MDS Sciex division. This joint venture was established in 1986. Nanogen, Epoch Biosciences to merge Nanogen Inc. and Epoch Biosciences have signed a definitive agreement to merge Epoch into Nanogen in an all-stock transaction. While, Nanogen is a developer of advanced in vitro diagnostic products, Epoch Biosciences offers proprietary products that accelerate genomic analysis. The reason for the merger is that Epoch has a variety of products that are complementary to Nanogen's. Epoch has developed advanced technologies in its MGB Eclipse Probe System. And Nanogen has been incorporating Epoch's technology into its own assays. Epoch has several product offerings for molecular research and diagnostic applications, including research reagents and services for real-time PCR (polymerase chain reaction). In July, Epoch launched 21 MGB Eclipse detection reagents, real-time Analyte Specific Reagents (ASRs) for the molecular diagnosis of infectious and genetic diseases and cancer. The real-time ASRs are complementary to the NanoChip Molecular Biology Workstation, which accomplishes more complex analysis of multiple markers. "By adding Epoch's high-quality products, we expect to increase our productivity, expand our customer reach and significantly grow revenue," said Howard Birndorf, chairman and chief executive officer, Nanogen." Under the terms of the merger, Nanogen will offer $2 per a share of Epoch. The companies have agreed that the exchange ratio will not be less than 0.4673 nor exceed 0.6329 of one Nanogen share. There are approximately 29 million Epoch shares and share equivalents outstanding. The directors of both companies and certain other stockholders of Epoch have signed an agreement to vote in favor of the transaction, which is expected to be tax-free to Epoch stockholders. The merger is expected to close by the end of 2004. ViroLogic, ACLARA BioSciences revise merger terms ViroLogic and ACLARA BioSciences have modified the terms of the Contingent Value Rights (CVR) in the definitive merger agreement previously executed by the companies. Though the CVR terms have been revised, the exchange ratio remains unchanged with each outstanding share of ACLARA common stock to be exchanged for 1.7 shares of ViroLogic common stock and 1.7 CVR. The companies have postponed their respective annual meetings previously scheduled for October 27, 2004. The meetings are expected to be rescheduled to occur later in the fourth quarter of 2004. "The revised CVR terms have several advantages for both the ViroLogic and ACLARA stockholders," stated William D Young, CEO and chairman, ViroLogic. The revised CVR provides for a potential payment in cash and/or stock of up to $0.88 per CVR, equivalent to $1.50 per ACLARA share (formerly $0.50 per CVR and $0.85 per ACLARA share, respectively), depending on the ViroLogic stock price 18 months (formerly 12 months) following completion of the merger. Under the revised agreement, the maximum payment under the CVR would be $0.88 per CVR, if ViroLogic's stock price trades at or below an average price of $2.02 per share (formerly $2.40) during the 15 trading days immediately preceding the eighteen-month anniversary of the closing of the merger, declining to $0.00 per CVR if ViroLogic's stock averages $2.90 per share or higher (unchanged from prior terms) during such time. If any payments are to be made on the CVR, the first $0.50 per CVR will be paid in cash. Any payments due beyond the first $0.50 per CVR can be made in cash, ViroLogic common stock or a combination of cash and stock, at the option of ViroLogic. The CVR is expected to be listed on either the Nasdaq Stock Market or the OTC Bulletin Board. Founded in 1995, ACLARA is a biotechnology company, which works in the area of personalized medicine through its protein-based assay technology-the eTag System. Cellegy to acquire Biosyn Cellegy Pharmaceuticals has signed an agreement to acquire Biosyn Inc., a privately-held biopharmaceutical company in Huntingdon Valley, Pennsylvania. Cellegy Pharmaceuticals is a specialty biopharmaceutical company that develops prescription drugs for the treatment of gastrointestinal disorders, women's health care conditions, and sexual dysfunction. Under terms of the agreement, Cellegy will exchange of 2.5 million Cellegy common shares for 100 percent of Biosyn's issued and outstanding capital stock. Cellegy will further invest $3.25 million into the business to satisfy certain balance sheet liabilities and will pay up to an additional $15 million upon launch of Biosyn's lead product, Savvy, a contraceptive gel for use by women to protect against the possible contraction of HIV-AIDS. The gel is part of a class of microbicides. Biosyn has two other anti-HIV product candidates in the pipeline. Magellan Biosciences, formed from ESA and Dynex Magellan Biosciences Inc. has acquired Dynex Technologies, a global supplier of microplate instrumentation and automation products for the biomedical research, drug discovery and clinical diagnostic markets. Magellan acquired the Dynex business from Capital Genomix Inc., a biotechnology company in Gaithersburg, MD. Financial terms were not disclosed. Including previously acquired ESA Inc., located in Chelmsford, MA, Magellan expects to generate consolidated revenues in excess of $30 million in 2004. Magellan Biosciences, which is majority owned by Ampersand Ventures, was established to build a leading life science tools company through a combination of internal growth and acquisitions. Dynex will operate as a subsidiary of Magellan, as will previously acquired ESA. Boston Community Venture Fund is also an investor in Magellan. "Microplates are the standard format for experimentation in life science research and clinical diagnostics, and Dynex has a strong presence in these markets with its line of microplate readers, washers and automated high throughput systems," explained Herbert Hooper, a general partner at Ampersand Ventures and chairman of Magellan's Board. GeneOhm Sciences, Infectio Diagnostic to merge GeneOhm Sciences (GSI) and Infectio Diagnostic (IDI) have announced their plans to merge and form a molecular diagnostic company. "The merger of GSI and IDI brings together a cost-effective platform for multiplexing, a broad portfolio of molecular targets and the capability to develop molecular diagnostic products for infectious diseases. Together, GSI and IDI will create a rich pipeline of products serving the unmet needs in key areas of medical diagnostics," said Dr Peter Klemm, CEO, GeneOhm Sciences. Dr. Klemm will continue as CEO in the combined company. The combined company will maintain its facilities in Quebec and in San Diego, creating competence centers that leverage the unique expertise of each organization. Argenta, Etiologics merge Argenta Discovery Ltd., a leader in integrated drug discovery services, and Etiologics Ltd, a respiratory drug development company, announced to merge. The merged firm will be known as Argenta Discovery and would provide comprehensive drug discovery contract research capabilities. Existing investors MVM Ltd, 3i, ABN AMRO Capital, Genavent and TTP Ventures have invested an additional £5.9 million ($10.5 million) in the new entity. Christopher Ashton, formerly CEO of Etiologics, would be the CEO of the new firm. "This strategic merger based on a sustainable business model unites two companies with complementary strengths and interests to create a leading provider of drug discovery services with particular expertise in respiratory drug research," said Dr. Ashton. ]]> <![CDATA[Suppliers Interview]]> https://biospectrumindia.com/news/95/1914/suppliers-interview.html https://biospectrumindia.com/news/95/1914/suppliers-interview.html Thu, 04 Nov 2004 15:06:00 +0530 "The Indian Continent Shows the Highest Growth Rate." Corning produces one of the most comprehensive lines of scientific laboratory products for life science research. Nils Kan, European sales director, Corning Life Sciences Division, was in India recently. He shared his views about the potential of the Indian subcontinent in this area. How do you perceive the global and the Indian life sciences industry? The existing life sciences industry is very healthy. The numbers in the US and Europe show a moderate growth. There is a lot of consolidation happening in the pharma and biotechnology industry. The Indian continent shows a higher growth rate than the rest of the world. This is very appealing fact. India, over the last couple of years, has evolved as a very solid biotech and pharma market. Initially known for generics, India is now rapidly moving into vaccine manufacturing. I think over the next five years, India is going to be a power to reckon with in the life sciences market. All the signals that we are getting from the scientists and the industry are very positive. India is poised for great things in the biotech market. China is also an important country in this region due to the sheer magnitude of the size and its work force is another hot spot. However, as far as life science market is concerned, China is trailing India. With time China is going to be another big hub. Life Science is an important segment for Corning. Why is it so and what is the overall focus? The guiding philosophy of Corning is to be at the forefront and a market leader in the various sectors it deals with. The life sciences division is one of the divisions of Corning Inc. We are into technology driven manufacturing with revenues well over $3.5 billion. Corning is an industry leader in segments such as optical fibers, liquid crystal display, environmental and of course life sciences products. We have a lot of core competencies. Some of them are process engineering, biochemistry, surface modification, plastic and glass manufacturing. The beauty of Corning is that we can combine technology from our different divisions and create a product. In the life sciences segment, we have a bright future ahead and are projecting to grow by about three or four times over the next couple of years. Corning is investing heavily in the life sciences division. About 10-11 percent of our revenues are reinvested into research and development. This shows our focus and commitment towards fundamental and applied research. How did the tie-up between Corning and Axygen happen? Corning has been present in India in an unstructured manner during the last couple of years. Since India is being regarded as a hot spot in life sciences, we decided to have a more structured and focused approach in the Indian life sciences market. We have been looking for a reliable partner with good market coverage and found that partner in Axygen, which has a good reputation in the market place. All the customers that I have visited are happy about the commercial staff and dealer network of Axygen. And Axygen will promote our cell culture and liquid handling brands. Rolly Dureha, New Delhi       ]]> <![CDATA[Indian doctors achieve breakthrough in Nanogeneseq technology]]> https://biospectrumindia.com/news/95/1959/indian-doctors-achieve-breakthrough-in-nanogeneseq-technology.html https://biospectrumindia.com/news/95/1959/indian-doctors-achieve-breakthrough-in-nanogeneseq-technology.html Thu, 04 Nov 2004 14:59:00 +0530 Indian doctors achieve breakthrough in Nanogeneseq technology Dr VS Ajith Kumar and Dr VS Arun Kumar Two general physicians from Thiruvananthapuram in Kerala, Dr VS Ajith Kumar and Dr VS Arun Kumar, have made use of the state-of-the-art Nanogeneseq chip technology to evolve a technique to prepare a genetic horoscope of a newborn. According to them, this technique will provide insight on a variety of diseases that could affect the child in its growth phases and adulthood. It could also predict the height, weight, color, physical attributes, eating habits and even romantic tendencies. More importantly, the tools would enable the medical community to predict and treat a wide range of diseases including Alzheimer's disease, HIV/AIDS, cancer, coronary artery disease and several others. According to the two doctors, the technique using Nanogeneseq chip is much superior to the conventional capillary electrophoresic technique as it provides a 90 percent perfect picture compared to the latter that can give only a 30 percent idea of the structure of DNA. Overlapping problems associated with conventional techniques is also solved using the new technology. The proteins in the cells could be more clearly picturized using the nanogeneseq chip. The samples used for DNA sequencing is blood, saliva, spinal cord or any body fluid taken from the child's body. The Nanogenseq chip is used in conjugation with Helinaser (Helical Nano Laser) that scans the sequences and finally establishes the horoscope. The technique has been patented in 90 countries through the Patent Co-operation Treaty and the technology is likely to be transferred to a global partner. Ultimately the technology will lead to the development of a "Digital Gene Card" that each one of us will carry throughout our lives. Treatment of diseases including medicines and its dosage will be based on the gene card, the doctors said. R Sreekumar, CyberMedia News Artificial retina in the making For the visually impaired, there seems to be light at the end of the tunnel. Research is being conducted under the Boston Retinal Implant Project on a retinal prosthesis, which on implantation in the eye could restore the sight of millions. The device would use a digital video camera mounted on a pair of glasses, coupled via a miniature transmitter to a retinal implant array underneath the retina. The array's electrodes would stimulate surviving nerve cells in response to images from the camera, providing a small patch of vision. The project aims to develop a microelectronic retinal implant to restore vision to patients with age-related macular degeneration and retinitis pigmentosa. Scientists are currently testing the implant design, which has unique features that improve its safety, function and performance. Research has shown that materials tested in animals seem to be biocompatible and might be eventually used in a human implant. Till date, in vivo tests have been done on six patients. It has been found that patients who have been blind for decades can see images in response to electrical stimulation of the retina. Also, the most typical single image seen by patients is relatively small. This result provides hope that many such small images could be created at once (by stimulating many electrodes at one time) to produce the perception of an object. Presently, a variety of studies are being pursued to collect information that is needed to obtain Phase I FDA approval to test the safety of the device following implantation in a human. The project hopes to test a permanent prosthesis by 2006. The idea of a retinal implant was conceptualized in the 1980s by Dr Joseph Rizzo and Professor John Wyatt, who initiated a collaboration between the Massachusetts Eye and Ear Infirmary-Harvard Medical School and the Massachusetts Institute of Technology. As the project grew, the center for innovative visual rehabilitation was established at the Boston VA Hospital to centralize the research and development effort. Zebrafish offers immunity clues For the first time, researchers have sequenced all 36 genes of novel receptors that appear to play a critical role in the innate immune protection of Zebrafish. This achievement could lead to a better understanding of infectious diseases and certain cancers. Till date, this is genetically the most complex system of innate immune receptors described and can be related to receptors in humans involved in Natural Killer cell (NK cells) function. In the human body, NK cells kill malignant cells and those cells infected with certain viruses. The Zebrafish scientifically known as Brachydanio rerio is a small species of freshwater aquarium fish. It is increasingly serving as an animal model for the study of genetic diseases. Like humans, it has two types of immune systems-innate and adaptive. Innate immune systems provide a first line of defense against foreign microorganisms. But, humans and other jawed vertebrates have also evolved more customized or adaptive immune systems, which use an arsenal of antibodies and T-cell receptors to fend off diverse pathogens and prevent repeat attacks. The principal investigator of the study, Gary Litman, Hines Professor of Pediatrics, working at the Children's Research Institute at the University of South Florida along with his colleagues is trying to tease out details about the evolutionary transition from innate to adaptive immunity with powerful new biotechnology techniques. They searched the genome of the Zebrafish and identified a class of genes, called Novel Immune-Type Receptor (NITR) genes, which are predicted to be capable of recognizing a wide range of surface molecules. A portion of the NITR genes is very similar to variable region genes of antibodies and T-cell receptors. They hope to use the fish as a tool to better understand how innate immunity may ignite adaptive immune response and to investigate potential therapies for immune deficiencies in humans. Their paper, titled "Resolution of the novel immune-type receptor gene cluster in zebrafish," has appeared in the Proceedings of the National Academy of Sciences. Human chromosome 5 unveiled Four years after publicly revealing the official draft human genetic sequence, researchers have reached the halfway point in deciphering the book of life. Chromosome 5 is the latest completely sequenced chromosome to join the ranks taking the tally of deciphered chromosomes to 12. Now there are another 12 more chromosomes to decode. As the new sequence reveals, this chromosome is a genetic behemoth containing key disease genes and a wealth of information about how humans evolved. This is the second of three chromosomes that the Department of Energy Joint Genome Institute (JGI) has finalized in collaboration with colleagues at the Stanford Human Genome Center (SHGC). JGI, in partnership with SHGC, completed the sequencing of three of the human genome's chromosomes-numbers 5, 16 and 19-which together contain some 3,000 genes, including those implicated in forms of kidney disease, prostate and colorectal cancer, leukemia, hypertension, diabetes and atherosclerosis. Chromosome 5, the largest to be completed thus far, is made up of 180.9 million genetic letters-the As, Ts, Gs, and Cs that compose the genetic alphabet. These letters spell out the chromosome's 923 genes, including 66 genes that are known to be involved in human disease. Another 14 diseases seem to be caused by chromosome 5 genes, but they haven't yet been linked to a specific gene. FDA approves the first ever total artificial heart While efforts are on to develop an artificial retinal implant to restore vision, another group of researchers have developed a total artificial heart. Christened as "CardioWest", the temporary heart is a pneumatic, biventricular, implantable bridge-to-transplant system for non-reversible heart failure patients awaiting heart transplants. The device has been approved by the US FDA for patients at risk of death from biventricular heart failure. Significantly, this is the first FDA-approved temporary total artificial heart, though numerous devices that replace major parts of the heart are presently in the market. CardioWest completely replaces the patient's diseased heart and immediately restores normal blood pressure and cardiac output, facilitating recovery of end-organ function, such as the kidney and liver. As a result, patients become better candidates for transplantation. The device offers full circulatory support, the shortest blood path and exposure to artificial surfaces and the highest level of cardiac output when compared with other artificial heart systems previously tested. Researchers who worked on the forerunners to today's mechanical hearts in the 1960s assumed that such devices would need to function flawlessly for years. At the time, heart transplants were not seen as a practical therapy because the implanted organs were quickly rejected by the patient's immune system. The idea of a permanent implanted artificial heart persists but, once the development of drugs that suppress organ rejection created a transplant industry, doctors began to study artificial hearts as short-use tools to keep patients alive until natural hearts became available. CardioWest has been developed by SynCardia Systems, a start-up based in Tucson and privately held developer of biomechanical cardiac replacement and assisted devices. ]]> <![CDATA[Double walled incubators from Toshibha]]> https://biospectrumindia.com/news/95/6607/double-walled-incubators-from-toshibha.html https://biospectrumindia.com/news/95/6607/double-walled-incubators-from-toshibha.html Thu, 04 Nov 2004 14:59:00 +0530 Double walled incubators from Toshibha The double walled incubators from Toshibha are constructed with inside aluminum/ stainless steel chamber having 60-70mm glass wool insulation. The door is fitted with heavy chrome plated hinges and spring and roller type latch hatch. It is provided with adjustable steel/aluminum/wiremesh tray for better air circulation. Temperature is recorded by means of "L" shape thermometer fitted at the front of the cabinet. Heating elements are made from high-grade (Kanthal ISI) resistance wire. Heaters are fitted along all sides and bottom. For further details contact: toshiba@del3.vsnl.net.in Next generation mass spectrometer from Waters Waters is introducing Q-Tof premier mass spectrometer, the next generation exact-mass API/MALDI MS/MS platform for the pharmaceutical, biotechnology and life science industries. The Q-Tof premier mass spectrometer, featuring T-WAVE (Travelling Wave) technology, is believed to offer significant enhancements in mass measurement accuracy, dynamic range (pDRE), sensitivity (enhanced duty cycle) and speed. Waters Q-Tof premier offers simplistic operation with the finest blend of innovative analytical capabilities. The Q-Tof premier has been designed in conjunction with ACQUITY UPLC to deliver ultra performance system solutions for the challenging applications in these industries. For further details contact: waters_india@waters.com Labmate to distribute VACUSAFE comfort The new VACUSAFE comfort from INTEGRA Biosciences represents a benchmark in liquid aspiration, filtration and waste disposal that will appeal to many pharmaceutical, biotech, clinical and chemical laboratories and will be distributed by Labmate in India. The new system has added features enhancing ease of use, performance and operational safety. New quick connectors facilitate easier handling and are color coded to eliminate the chances of incorrect set-up. The ultra-low noise pump technology enables the system to provide infinitely variable vacuum control enabling gentle aspiration from the microlitre range right up to rapid emptying of relatively large containers. The VACUSAFE comfort incorporates all the essential elements for safe and productive disposal of liquid waste. Coupled with the ergonomically profiled VACUBOY hand operator and a range of adapters, the system provides the flexibility to aspirate supernatant liquids from cell culture vessels, centrifuge tubes, 24- and 96-well plates and sample vials. Furthermore, it fits any existing vacuum source in a laboratory offering a powerful tool to handle liquid aspiration, waste disposal and filtration applications. For details contact: labmate@vsnl.com Memmert cooler incubators to meet tomorrow's demands Through its innovative technical developments in heated ovens and incubators, Memmert is introducing INCO-2 cooler incubators. These incubators have digital CO2 control based on the unsurpassed NDIR measuring principle, turbulence-free internal ventilation system fully integrated into the sterilization process. The incubators have automatic all-round sterilization, which covers sensors, ventilation and water reservoirs and reliably prevents any contamination due to the incubator. The humidity limit system is adjustable at 88-97 percent. For further details contact: mail@biodigitalindia.com High throughput solvent evaporation system launched The HT-8 Series II system is designed to provide the solution for evaporation bottlenecks in the drug discovery laboratory. The system's high performance and high sample capacities make them the ideal workhorses for the laboratory requiring high throughput evaporation. The HT-8 system accommodates a wide range of sample formats. The strong stainless rotors are housed in a cast aluminum vacuum chamber, protected from attack by corrosive vapors by a reinforced perfluorinated coating. The rotors incorporate 8 "sample swings" to accommodate Genevac sample holders for tubes and vials, microtitre plates and custom sample formats. The systems are ready for use with microtitre plates and many microtitre footprint tube racks or reaction blocks. For further details contact: spincomd@md4.vsnl.net.in Clean in place module from Adam Fabriwerk Adam Fabriwerk Pvt Ltd has introduced Clean In Place (CIP) module, a process used to ensure that process lines, vessels and reactors are free of inorganic and organic contaminants in critical cleaning applications. This compact and fully automated system is microprocessor controlled. It has an integrated validation and automated monitoring system too. The CIP module is used to clean manufacturing vessels ranging from 50 liters to 500 liters capacity. For details contact: adamfab@vsnl.com Sartorius launches new electronic platform scales Sartorius Mechatronics, which encapsulates the consolidation of Sartorius technology and knowledge acquired from the other group companies such as Global Weighing and Boekels on one common platform, has introduced "Combics", a new range of electronic platform scales that fits the needs of different kinds of industries. Combics platform comes in two versions, painted and stainless steel, from which the customer can choose with a whole range of applications like weighing, counting, check weighing, classification (3 or 5 classes), totalizing, net-total formulation, filling, weighing in percent, or neutral measurement. "BioDoc-It", a new imaging system for the Indian market UVP Inc.'s new gel documentation system "BioDoc-It" is now available in India. This imaging system offers a stand-alone gel documentation workstation for fluorescent and colorimetric imaging. It is designed as a standalone imaging system that requires no computer. The system includes a monochrome CCD camera along with the compact darkroom and UV transilluminator. It has a unique gel window, which opens for quick sample viewing without opening the door and displays a live preview of images on the integrated five-inch flat panel display monitor. The other important features of the system are over saturation flash warning, mini darkroom with dual overhead white lights, control camera integration with built in processor control pad, etc. The BioDoc-It system is being distributed in India by the Chennai-based Spinco Biotech Pvt Ltd. For further details, contact: spincobg@bgl.vsnl.net.in BioRad introduces Bio-Plex suspension array system Bio-Rad has introduced Bio-Plex suspension array system, which is a drug discovery tool. It couples bead arrays with flow based fluorescence detection to analyze 100 different analysts in single sample. It is like running 100 different Elisa or Western blot in single sample with three-dimension reaction approach. Multiplexing reduces the time, reagent and sample requirement. It is both a qualitative as well as quantitative method to analyze different parameters. Based on Luminex technology and integrated advanced Bioplex manager software with US FDA part 11 21 CFR compliance, it helps in medical diagnostics, biomarker discovery, proteomics and genomics applications. The assays available are Cytokine profiling single plex or multiplex (19 cytokines); phoshokinases study single plex or multiplex (9 Posphokinases); and Amine coupling COOH bead for customers interested in developing their own protocol. For further details, visit: www.bio-rad.com   ]]> <![CDATA[National Biotech Policy 2005]]> https://biospectrumindia.com/news/95/2454/national-biotech-policy-2005.html https://biospectrumindia.com/news/95/2454/national-biotech-policy-2005.html Thu, 04 Nov 2004 14:53:00 +0530 The Parleys Begin Kapil Sibal The biotechnology sector started to take shape in the country more than two decades ago. In the last five years, the biotechnology industry has really taken off and is about to cross the $1 billion mark. Yet, the country does not have a clearly defined policy framework for the biotech segment. The inaugural issue of BioSpectrum in March 2003 started the demand for a well-articulated National Biotechnology Policy. A year later, now there is a lot of action related to the formulation of a national policy for biotechnology. The government is all set to announce a national biotech policy in January 2005. A report about the recent actions on this front. The new secretary in the Department of Biotechnology, Dr M K Bhan, has been stressing the need to formulate the national policy ever since he took over in March 2004. The new Union minister for science and technology, Kapil Sibal, has been talking about the need for such a policy since assuming office in May 2004. Together, these two policy makers are set to put Indian biotechnology on a growth path. What gives hope is their public statements on the sector in recent months. The government clearly recognizes that it is alive to the concerns of the industry as biotechnology has tremendous potential to resolve some basic issues like poverty, hunger and diseases. It is very important to India. The government is going to come up with new biotech policy in January 2005. It will give all the parameters-the policy statement. Once the policy is done, then the single window clearance and other procedural issues will be addressed. In the BT sector, there is a need for influx of venture capitalists(VCs) in a big way. The government has to open up the sector and attract a lot of foreign direct investment(FDI). The Union Minister for Science and Technology, Kapil Sibal met biotech CEOs in Bangalore who came together under the Association of Biotechnology-Led Entrepreneurs (ABLE) on October 21, 2004. The Union Minister of State for Science & Technology, Kapil Sibal, has been stating these at every industry forum. These statements definitely are not mere slogans. He means business. During the last 15-20 days, there has been a lot of action. He is meeting the industry and speaking to them. He has announced that he would be accessible to listen to the issues that need to be addressed urgently. On October 21, 2004, he met biotech CEOs in Bangalore who came together under the Association of Biotechnology-Led Entrepreneurs (ABLE). During the meeting, BioSpectrum discovered that the minister was thorough with his understanding of the industry and wanted to get more in depth the industry issues. He was alive to the suggestion of the CEOs and was noting down each point that was being talked about. He assured the captains of the industry, "In the last couple of years the government at the policy level has realized how important biotechnology is in India. There are 96 biotech companies in India. BT has tremendous potential. It is important because we can resolve basic issues like poverty, hunger and diseases, besides the potential of exports." Sibal spelt out what was on top of his agenda. A national biotech policy by January 2005, a national bioinformatics policy by January 2005, compliance with the global regime on intellectual property rights, quadrilateral agreement between the academia, industry, laboratories and the state and addressing the procedural issues. He assured that major issues would be addressed on priority. And the government has already initiated some positive measures in that direction. For example the biotechnology parks have got the status of EoUs. He has spoken to the Finance Minister and that the minister was alive to the idea that the same concessions and exemptions like that in the IT sector be given to the BT sector. Further, he pointed out that the large animal testing is also being allowed. Discussions begin At the inaugural conference of the Bangalore Bio 2004 in July, Dr MK Bhan, secretary, Department of Biotechnology, announced that a comprehensive National Biotechnology Policy would be put in place in the next six to seven months. Concurrently, the Union Science and Technology minister Kapil Sibal opined that the Biotech Policy would be ready by January 2005-when India embraces the product-patent regime. It may be recalled that in its inaugural issue in March 2003, BioSpectrum had initiated an informed national debate on the framing of a National Biotechnology Policy. Now that the ball has been set rolling and the government machinery is working to draft the policy, BioSpectrum too is following up with the trials and tribulations of evolving a biotech policy for the country. At the Bangalore Bio event Dr Bhan elaborated on the agenda of the policy and said, "The policy would outline clearly the government's thrust in the field including attracting investment and enforcing regulations. A commission would be set up to frame the national biotech policy that would include crucial elements from the Mashelkar Committee on pharma biotech and MS Swaminathan Committee on Agri biotech". "A group would frame guidelines and advise the biotechnology department on the model to be adopted in public private partnership in this segment", he added. The Indian government had announced a Science and Technology (S&T) policy in January 2003, which gives a broad open-ended framework for application of S&T for the benefit of the society. The proposed biotech policy, keeping this S&T policy as a base, would address specific policy issues in relation to biotechnology and also outline the future strategy and road map. The Task Force The government has set up a task force under the chairmanship of DBT secretary Dr MK Bhan. The Union minister for science and technology, Kapil Sibal is keen to formulate a national policy on biotechnology and put in place a single window system of clearance of transgenic products by January 2005. The Bhan Task Force will use the suggestions of the M S Swaminathan Task Force Report on agricultural biotechnology and the forthcoming report of the Mashelkar Task Force on recombinant pharma products.The government also plans another panel to recommend the use of transgenic products and crops in food and processed foods. The Bhan Task Force is also expected to recommend "strategies for translation of the biotech policy towards full utilization of the potential of the technology for human welfare and economic development." It would also recommend setting up of sub-committees in different sub-sectors and draw a roadmap for these sub-sectors for the next 10 years. It would propose modifications to the existing laws and procedures in involved in regulation of transgenic products, suggest incentives for promotion of trade and investment in biotechnology and measures for creating awareness of the overall status and new initiatives. The other members are : 1. Dr M.K Bhan, Secretary, DBT-Chairman 2. Dr Mangala Rai, DG, Indian Council of Agricultural Research (ICAR) 3. Dr N K Ganguly, DG, Indian Council for Medical Research (ICMR) 4. Prof G Padmanabhan, Professor Emeritus, Indian Institute of Science, Bangalore 5. Dr Suman Sahai, Convenor, Gene Campaign, New Delhi 6. Prof P N Tandon, Chairman, National Brain Research Center, New Delhi 7. Dr D Balasubramanian, Director(Research), LV Prasad Eye Institute, Hyderabad 8. Prof C R Babu, University of Delhi 9. Dr P N Bhatt, former DDG, ICAR 10. Dr M Vidyasagar, Sr VP ( Advanced Technology), TCS, Hyderabad 11. Prof A S Kolaskar, Vice Chancellor, University of Pune, Pune 12. Mrs Kiran Mazumdar-Shaw, CMD, Biocon & President, ABLE, Bangalore 13. Dr Swati Piramal, Director, Nicholas Piramal, Mumbai 14. Mr Rakesh Rewari, CEO, SIDBI Venture Capital Ltd, Mumbai 15. Mr Raju Barwale, CEO, Mahyco-Monsanto, Mumbai 16. Dr Rama Mukherjee, Dabur Research Foundation, New Delhi 17. Mrs Anuradha Desai, CEO, Venkateswara Hatcheries, Pune 18. Mr K O Issac, CEO, ABL Biotechnologies, Chennai 19. Dr R Bharatiya, Jubilant Organosys, New Delhi 20. Dr S E Hasnain, director, Center for DNA Fingerprinting and Diagnostics,Hyderabad. 21. Dr Renu Swarup, director, DBT ( Member Secretary) In addition, the secretaries of the ministries of agriculture, health, environment & forests, commerce, industrial policy and information technology will also be members of this committee. The central aim of the Biotechnology Policy and Strategy would be towards full utilization of the potential of biotechnology for human welfare and economic development. For this, the policy would contain specific proposals and action points, incentives and programs. In addition to being a policy document, it would give a strategic direction to different sectors to accelerate the pace of development of biotechnology for the next ten years in the country. New models of center-state, private-public, R&D-industry partnership, inter ministerial, inter institutional/agency coordination would be worked on to exploit the full potential of the country in this sector. A high level main committee for drafting the Biotech Policy and Strategic Action Plan consisting of 30 experts has been constituted. Since biotechnology involves various sectors, 12 sub committees consisting of 5-8 specialist members have been created, each headed by a group leader. The various sectoral or subcommittees include: medical biotechnology, agricultural biotechnology, bioresources including sericulture, food biotechnology, animal and dairy sectors, marine biotechnology, environmental biotechnology, bioinformatics, industrial biotechnology, investment and trade, traditional including biofertilizers and biopesticides, human resource development. Each sectoral committee will identify the thrust areas, prepare an action plan and status paper in their respective sub sector. This is aimed at developing a knowledge base in that sectoral area and will outline a strategy map for the future. The sub committees will provide this information to the main Biotechnology Policy Framework Committee (BPFC). After further deliberations, the final recommendations of the main committee will be put on the Internet for public comments. Some of the sectoral committee meetings have taken place while others are in progress. The first meeting of the main committee took place on October 27. There are some questions like what should be the rationale behind selecting or rather leaving sectors out of preview of the policy? A bioinformatics policy is already in place and is put on the Internet. So should each sector have a separate policy? Will the biotechnology policy prompt to the creation of some legislations as was the case with other policies like the Drug policy, Seed policy and Exim policy? Dr KK Tripathi, advisor on regulatory affairs and policy matters in DBT, has suggested that the policy document may address specific issues related to: promotion of research and development, technology transfer and commercialization, public-private partnership, capacity building, human resources development, infrastructure strengthening, international cooperation regulatory framework, biosafety, IPR, trade and investment, social and ethical issues and communication and public awareness. Dr Manju Sharma, former secretary DBT, commented, "My perspective is that biotechnology is a part and parcel of India's science and technology policy. What is needed is to implement the first vision document (2003 Science and Technology policy) for five years. This would help to create a knowledge based society, thrust on institutional development, poverty alleviation, large projects of societal upliftment, intensify research, convert leads to products, processes and technology and benefit the poorest of the poor, for whom this technology is meant. I look at biotechnology in a very broad perspective. For example if a vaccine is developed through a biotech-based technique, then the prices will crash and the poor, deprived section of the society will benefit the most." The first few suggestions Sibal has been thinking laterally and the industry too needs to become proactive to help the framers of the policy. The Minister has asked the industry to be realistic in its expectations and approach. For instance, the proposal for a national biotech fund with Rs 200 crore corpus. He said he would be going to the Finance Minister with the proposal, but opines that arriving at a solution which is within the purview of his ministry, will be a more realistic one. He cites the case of Pharmaceutical Research and Development Support Fund (PRDSF). The initial discussions started for Rs 150 crore as grant every year and ultimately it ended up with Rs 25 crore. That too as a corpus and spending is out of the interest earned. "I do not see realistically any BT fund coming out. So it is better to address the issue ourselves. We realize by and large that no movement can take forward without public, private partnering. The level of funding in the budgetary allocation can be asked to be increased so that the government can partner with private players through the DBT for project finance. A model has to be put in place. Everybody is ready to do this. The model that can be in place is we give the knowledge for equity. We are risking the transfer of knowledge for free of cost. That is a model I know can work and can be conceived," Sibal reportedly told the industry gathering in Bangalore. Sibal also stressed on public-private partnership. In fact he stresses on a four-way partnership- Lab-Academia-Public-Private (LAPP). "We have to move forward with industry support in this field by way of public-private partnerships. We cannot do R&D in isolation, we have to collaborate with the industry and come out with products. The key to move forward is a quadrilateral agreement between the academia, industry, lab and the state. There should be synergy amongst all four of them. The academia and lab have to come up with the ideas and the supporting R&D work. While the industry and the State have to support them with the funding. Presently our R&D centers are like little oases of knowledge and since any science should not surpass the common good of people so we have to turn the entire country into a big oasis. The National Biotechnology Policy being drafted is taking care of these issues." Also the minister understands that the biotechnology sector needs the influx of VCs in a big way. "We have to open up FDI to the sector. Induct a lot of FDI," said Sibal. He is also open to the idea of incentivising the VCs. Addressing the issue of compliance to WTO norms, Sibal assured that that will be taken care of. The industry may not see the third amendment bill of IPR passed in the Parliament passed by January 2005 owing to the short time of the Winter Session starting in December. But industry sources are hopeful that an ordinance to that effect can take care of the concerns. The issue of data exclusivity has not been dealt with in the Third Amendment Bill to the Patents Act and is likely to be addressed in the biotech policy. One of the important things that the minister has set out is setting up an inter-ministerial group accommodating representatives from other ministries like the social welfare and health. The objective is to facilitate clearances in one go. How will the policy bolster the small entrepreneur? Take for example, the diagnostics sector, according to Dr Ravi Kumar, managing director, xCyton, the finished products from companies are imported at a much lower duty structure, while the entrepreneur has to pay higher import duties on every raw material. In a way, it is penalizing the entrepreneur. Sibal is keen on looking into such issues and as this is an export import issue and he will talk to the relevant people. Further, he wants the industry to give a list of such discrepancies so that he could convince the ministries concerned. There is a need for international accrediting institutions for both and clinical and other facilities. And guidelines for clinical trials will be taken up, which is not avoidable. He assured the setting up of Center for Public and World Class Biotech. He also believes that as the minister for Science & technology, there is a need for at least 20 institutions like IISc to build significant human resources. Dr Bhan sums up: "The Biotechnology Policy of India is continuously evolving but its basic concepts have been settled for creating a vibrant industry, wealth generation and for whatever biotechnology has to offer to the country. The whole policy framework has been structured in a way on how to use biotechnology in a pragmatic and sensible way for the betterment of the masses." Action has started at last on the policy front. The industry will wait with bated breath the unveiling of the promised policy come January 2005. Ch. Srinivas Rao and Rolly Dureha   ]]> <![CDATA[New Entrant, Quick Development]]> https://biospectrumindia.com/news/95/1827/new-entrant-quick-development.html https://biospectrumindia.com/news/95/1827/new-entrant-quick-development.html Thu, 04 Nov 2004 14:25:00 +0530 Intas Pharmaceuticals Ltd, a fast growing pharmaceutical company with an annual turnover of Rs 381 crore (financial year 2003-04), has entered the biotechnology space by launching recombinant human Granulocyte Colony Stimulating Factor (G-CSF) in August this year. With experience in marketing bio-generics and hepatitis B vaccines in the domestic market, Intas Pharmaceuticals entered the biotech field in 2000 with a view to emerge as a research based manufacturer of quality biopharmaceuticals and become a significant global player in the bio-generics market. And it set up Indus Biotherapeutics Ltd, a wholly owned subsidiary of Intas dedicated to biotech R&D. The group has invested over Rs 35 crore in developing research and manufacturing facilities. Indus Biotherapeutics Ltd has successfully developed from lab scale-to-clinic recombinant human G-CSF for Intas Pharmaceuticals, which is marketed by Intas Pharmaceuticals under the brand name Neukine. Indus is a DSIR approved R&D company. The team at Indus consists of 35 young researchers educated in premier institutes and having doctoral or postdoctoral experience in India, the US, Europe and Japan. It has shown that it has the capabilities to transform biotechnology discoveries into quality therapeutic products in a short time and in a cost-effective manner. It also provides contract research services to companies and groups seeking to develop recombinant products, with capabilities and expertise for development of up-stream fermentation / cell-culture based process, down-stream purification of proteins, protein characterization and analysis, stability testing, animal toxicity studies, handling multi-centric clinical trials, etc.. Intas Pharmaceuticals has a state of art manufacturing plant at Moraiya near Ahmedabad for manufacturing recombinant therapeutic proteins. The facility, covering 20,000 square feet area is capable of producing gram quantities of recombinant proteins under GMP conditions. It has the cGMP and process development expertise that is critical to successful manufacturing of complex pharmaceuticals and biologics. At present, Intas is working on developing two-three generic recombinant biopharmaceutical products and many more are in the pipeline. These products are expected to lose patent protection soon and are being developed for global biogeneric markets. The product development meets the quality requirements laid down by the US and European regulatory authorities. Besides Neukine, there are two more products-EPO and Interpheron alfa 2b (both recombinant therapeutic products)-which are under clinical trial stage and another four rDNA products that are under development stage. The company focuses on recombinant proteins based products mainly in the oncology and nephrology segments. For manufacturing, it has used cell culture and fermentation technology. Intas intends to make its products available in pre filled syringes and depending upon the nature of the products, these would made available in the liquid or lyophilized forms in vial as well. With a committed approach and continuing focus on research and innovation, it has succeeded in bringing international standards in setting up a highly sophisticated manufacturing plant acclaimed as one of the finest in South East Asia. This plant is WHO approved and meets US FDA standards. Its pharma plant, also at Ahmedabad, has received approvals from many regulatory authorities like MCA (UK), TGA (Australia), MEB (Netherlands), MCC (South Africa), AFI (Belgium), Anvisa (Brazil) and FDA (Nordic Countries). To take an early lead in the biotechnology space, Intas is actively collaborating with several research labs in the Europe and the US, turning laboratory scale technologies into commercially viable, cGMP compliant manufacturing processes. Indus Biotherapeutics is also working towards active tie-ups with several leading research labs and institutions in India. Recently, Intas has entered into a tie up with Avasthagen, a research focused biotechnology company from Bangalore. "Such tie-ups between two like-minded organizations and commitment of the management to focus on R&D will definitely pay the fruits for Intas in the coming years," say key officials in the company. Narayan Kulkarni "We Plan to Release One Product Every Six Months" Dr Urmish Chudgar, a practising haemato-oncologist who is passionate about biotechnological development for better human health, is the director, Intas Pharmaceuticals Ltd. He is the man behind the biotech initiatives at Intas Pharmaceuticals. At Indus Biotherapeutics Ltd, a wholly owned subsidiary of Intas dedicated to biotech R&D, he plays a key role in strategic development, business growth and team building. He details out his company's interest in biotechnology and its future plans. When did Intas initiate its biotech activities and what were the reasons for the same?  We started planning our entry into biotechnology in 1999 and actually initiated the activities in the middle of 2000. Biotechnology is a growing area within pharmaceuticals internationally, as more than 50 percent of the products are in early stage of development today and will become marketed products over the next 10-15 years. And these are biotechnology based. We expect that entering biotechnology at this stage will put us in a position to be a part of this phenomenon. Biotechnology will be an important component of the company's growth in the coming years and fits in well with our strategy of increasing international operations and adding specialized capabilities within the organization. You have biologicals (vaccines), contract research (Indus Biotherapeutics) and recombinant products in pipeline (besides Neukine)? What is your core area of focus?  Currently our focus is on recombinant products. We launched Neukine, recombinant G-CSF a few months back and we have a rich pipeline of products that we expect to bring to the market at regular intervals. Two of our products, EPO and interferon alpha, are in advanced stages of development. What is your marketing strategy for recombinant biologicals as companies are finding it difficult to market their products?  We don't perceive any unique difficulty in marketing biopharmaceutical products per se. Every product has its own challenges. Intas has a strong presence amongst the speciality segments like oncology, cardiology, nephrology, neurology and gastroenterology, which are some of the high growth segments. All our major biotherapeutic offerings are for such speciality segments, wherein we will have a natural advantage due to our existing strengths.  Biotechnology products are complex products and we are confident that our offering of well characterized, quality products will find acceptance. One particular feature of biotech products is that they are usually high priced and affordability is an issue. We keep this factor in mind and try to provide products at an acceptable price level.  What is your R&D investment in biotechnology and turnover from these core areas?  We have invested upwards of $10 million in our biotechnology venture. Since this is our year of entry into the market, we expect the revenues to cross $1 million this year, and grow at a CAGR of over 50 percent over the coming five-six years. We expect a major portion of the revenues to come through exports.  When are you going to launch your biotechnology products in the regulated market outside India?  We have a focused strategy of starting with the Indian market, expanding to non-regulated market and then moving to the regulated market. We plan to target the regulated markets by about 2007. What are your current capabilities in vaccines and biologicals?  We have in-house capability in the vaccines area but as of now we are not focusing on vaccines.  Are there any major hurdles that you are concerned with in biotechnology?  Developing biotechnology products is a slow and long process involving a number of scientific, financial and regulatory challenges, but there are no specific hurdles. We are quite happy about the recent initiatives taken by the government to rationalize regulatory procedures. We also hope that the government will ensure equally stringent scrutiny of imported biopharmaceutical products, as is applied to indigenously developed products, to provide a level field to research-based domestic manufacturers.  What are your future plans? We are going to build excellence in product development and manufacturing. We are committed to bringing to the market one product about every six months. Starting with generic products, we will gradually move towards innovative products and having our own intellectual property. We intend to build these capabilities by strengthening in-house R&D as well as working through a network of domestic and international collaborations.   ]]> <![CDATA[Analytica-Anacon 2004]]> https://biospectrumindia.com/news/95/1583/analytica-anacon-2004.html https://biospectrumindia.com/news/95/1583/analytica-anacon-2004.html Thu, 04 Nov 2004 14:24:00 +0530 Analytica-Anacon 2004 The second international trade fair and conference for analytical instrumentation, biotechnology, laboratory technology and services, Analytica-Anacon 2004, will be held from November 25-27, 2004 at Nehru center in Worli, Mumbai. This fair provides a platform for analytical instruments and laboratory technology in India and will offer a meeting point for buyers and sellers from a wide cross section of the industry. The themes for the conference are industrial analysis, biotechnology and lab automation. Experts from the industrial, scientific and research sectors are expected to attend the fair and the concurrent conference. For further details, contact: soniaprashar@indo-german.com Biologic Asia 2004 Biologic Asia 2004 is being held from November 17-19, 2004 at Raffles City Convention Centre in Singapore. The event focuses on the Asian biological manufacturing sector. The conference aims to deliver integrated scale-up and manufacturing solutions. It will also showcase the cost effectiveness of Asian manufacturing, offer insights into issues that concern today's biologic players in the region and provided a platform for delegates to share experiences. The event will bring together the leading people from the pharmaceutical, biotech and supplier sectors. For further details, contact: stella.teo@terrapinn.com Rapid Microbial Methods IBC is organizing a conference on "Rapid Microbial Methods" from December 1-2 2004 in Emerald Plaza at San Diego, CA. The event will address issues related to regulations, technologies and practical applications for better quality control of manufacturing processes. In addition, there will be 2 mini-tutorials held during the conference. The event will feature sessions on Regulatory landscape - FDA's requirements, inspection compliance and harmonization status; Business and economic justifications-evaluating ROI for implementation of rapid methods; Emerging and novel technologies, methods and applications from micro arrays to MALDI-TOF to rapid Mycoplasma designing tests-covering comparability protocols and mycoplasma compliance testing; and Evaluation and validation of rapid methods-case studies of successful tests and applications of rapid microbial methods. For further details, contact: reg@ibcusa.com Bio-Europe 2004 BioEurope 2004 will be held on November 8-10, 2004 at Cologne in Germany. It is one of Europe's largest international partnering conferences, which celebrates its 10th anniversary this year. The conference provides a forum where international decision makers in the biotechnology, pharmaceutical and financial sector can meet to initiate or develop partnerships among their companies. Bio-Europe operates a software system that allows attendees to preselect and meet with potential partners and focuses on issues relevant to partnering (e.g., deal making, finance and clinical development). Over 3,300 meetings were prescheduled at its conference last year in Frankfurt. The event provides an opportunity to attendees to present their company backgrounds and partnering goals to everyone in attendance. For further details, contact: fschoenhammer@ebdgroup.com Biology In Asia An international conference, "Biology In Asia", co-organized by The Singapore Institute of Biology; Department of Biological Sciences (National University of Singapore); and the National Institute of Education (Nanyang Technological University) will be held from December 7-10 2004, in Singapore. The conference aims to provide a platform for interaction and exchange of the ideas and techniques in the business of biology-from the fields of education, to research, and to applied biology-especially with respect to Asia. The three sub-themes for the conference are "biodiversity, ecology and conservation in Asia"; "biotechnology in Asia"; and "biology education in Asia". The event marks the 30th anniversary of The Singapore Institute of Biology (SIBiol) in 2004. For further details, contact: dbsbox5@nus.edu.sg In Vivo Molecular Imaging The Cambridge Healthtech Institute is organizing a conference on "In Vivo Molecular Imaging" on November 16-17, 2004 at Marriot Hotel, La Jolla in California. The theme of the event is bridging the gap from pre-clinical to clinical applications. The conference will examine the development of specific and efficient intracellular targeting and imaging systems that provide high resolution as well as high sensitivity. The speakers at the different sessions will highlight latest advances and issues related to technology innovations, pre-clinical imaging and clinical applications. For further details, contact: chi@healthtech.com ]]> <![CDATA[The Green Revolution and the Gene Revolution]]> https://biospectrumindia.com/news/95/2218/the-green-revolution-and-the-gene-revolution.html https://biospectrumindia.com/news/95/2218/the-green-revolution-and-the-gene-revolution.html Thu, 04 Nov 2004 14:11:00 +0530 There should be a well thought out national policy on agricultural biotechnology after widespread consultations with a range of stakeholders. Agbiotechnology is presented in many forms. The most common being that it will solve world hunger. To reinforce this claim, there is an interesting word play at work. Agbiotechnology is referred to as the "Evergreen Revolution" or the "Gene Revolution". Both these terms are an attempt to link agbiotech with the Green Revolution. In the view of most political leaders, policy makers, farmers and citizens, the Green Revolution was a positive happening that brought benefits. It did in fact increase food production, principally cereal production. It made India independent of food exports and firmed up its political spine. It ensured surplus grain that could be stored in buffer stocks to be rushed where need arose and it tried to ensure that famines were not a feature of the Indian reality. These gains were so visible that the downside, the unequal distribution of the benefits of land and water degradation, the accompanying loss of genetic diversity and the persisting endemic hunger and poverty, could not take the shine off the Green Revolution. Because of this positive image, the promoters of agbiotech draw semantic parallels, invoking the earlier agricultural revolution. The subliminal message is if the Green Revolution brought so many benefits, the Evergreen Revolution would bring all those in perpetuity. The word play has actually been quite successful. Political leaders and policy makers carry over the positive association with the Green Revolution to the Evergreen one. If the earlier version brought such benefits, the newer one (more precise, with greater possibilities, as the industry says) would surely bring even greater benefits to the farmers and the poor. Conveniently left out of this portrayal are the essential and crucial differences between the two "Revolutions". The Green Revolution was a publicly owned technology, belonging to the people. The research was conducted with public money to fulfil a public need, inadequate food production, and it created public goods to which everyone had access. There were no Intellectual Property Rights (IPR), no patents vested in multinational companies, no proprietary technologies or products. If there was ownership of the Green Revolution, it was vested in the farmer. Once the seed reached the farmers, it was theirs; they moved it where they wanted. Therefore despite its faults, the Green Revolution addressed farmers needs and India's food production showed an upward curve. The Evergreen Revolution is almost the exact opposite. It is a privately owned technology. Six corporations (Monsanto, Syngenta, Bayer CropScience, DuPont , Dow and BASF Plant Science) control practically the entire research and output in the field of transgenic plants, processes and products, including research methodologies are shackled in patents and the farmer has no say, let alone any control. The technology creates only private goods that can be accessed only at significant cost (a bag of Mahyco-Monsanto's Bt cotton seeds in India costs Rs 1,600 as compared to Rs 300-400 for superior varieties produced locally). The seed belongs to the company, which strictly controls its movement. With the development of the popularly termed "terminator" or sterile seed technology, the farmer is reduced to a helpless consumer, not a partner as in the case of the Green Revolution. The Evergreen Revolution has in its 20 years, not yet produced a crop variety that has any direct connection to hunger and nutritional needs. The most prevalent crops remain corn, soya, cotton and canola and the dominant traits are herbicide tolerance and insect resistance. Despite its other faults, the Green Revolution was able to put out a number of crop varieties in a short span of time that enabled direct yield increases, which brought immediate benefits to farmers. That in short is the contrast between the two revolutions, so assiduously camouflaged by the agbiotech spinmeisters. India had participated enthusiastically in the Green Revolution and is on its way to equally enthusiastically embrace the Gene revolution or Agbiotechnology. Yet there is little debate in the country on whether any lessons have been learnt from the Green Revolution. There is even less debate between policy makers and other stakeholders about the path that agbiotechnology should take in India. There is no consultation with the public like in many other countries, for example in Europe or any sharing of information, as is done in almost all countries that are implementing GM technology. The Department of Biotechnology has promoted research projects randomly in universities and research institutions, without any assessment of farmers' needs and the best way to fulfil them; civil society has been uneasy with the lack of transparency and the lack of competence in regulatory bodies; the media is largely uninformed and political leaders remain unaware of the direction this new and controversial technology was taking in India and have no say in determining what it should or should not do. It is time that the country gave itself a well thought out national policy on agricultural biotechnology. The policy should be framed after widespread consultations with a range of stakeholders. The process of consultations should be inclusive and transparent, allowing a range of expertise and insights to be brought into the decision making process. The greater the ownership of the outcome of the consultative process, the better will be the acceptance of the policy that is framed. Dr Suman Sahai has a Ph.D in Genetics and has several years of research and teaching experience in the Universities of Alberta, Chicago and Heidelberg. Dr Sahai is a member of several national policy forums on environment, biotechnology and Intellectual Property Rights as well as education and health. She is also the convenor of Gene Campaign, New Delhi. Suman Sahai can be reached at: genecamp@vsnl.com www.genecampaign.org     ]]> <![CDATA["Spurious" Science Dominates Anti-GM Debate!]]> https://biospectrumindia.com/news/95/5942/spurious-science-dominates-anti-gm-debate.html https://biospectrumindia.com/news/95/5942/spurious-science-dominates-anti-gm-debate.html Thu, 04 Nov 2004 14:08:00 +0530 As the international year of rice draws to a close, China as usual is getting ready to introduce GM rice commercially, whereas there is a beginning of a movement to not only ban its introduction to other parts of Asia, but also a call for a moratorium on commercialization of GM crops for a variety of reasons. At the same time, one cannot but help notice how far the polarized GM debate has traversed since it all began more than a decade and a half ago. Even though commercialization of GM crops is in full swing around the world without a single instance of anything having gone wrong, the anachronistic pitch continues to queer new heights. If it is not social impact, it is imaginary ethical impact and if it is not economic impact, it is about democratization of biotechnology, if not, it is about socializing biotechnology, or else it is the "ephemeral" public participation in the decision making process. What has happened in all of this is that GM crops have been "criminalized" without any scientific basis. There is no question that in this day and age, all human endeavors must be scrutinized and they all must jump through the hoops to pass muster called "public opinion". But, they must be done by knowledgeable people who have expertise and broad perspective of the role technology in development. But, when it comes to the question of assessing modern biotechnology, the knowledge and expertise of some of the stakeholders leaves much to be desired. Not withstanding the safe use of GM crops for almost a decade wherever they have been commercialized, there is a pervasive attempt to hoist false scientific charges against GM crops that are wantonly mischievous. GM crops have been tagged with a "guilty" label based on a faulty science, and now it seems that they have to be proven innocent by the scientists. That is to say prove that they are not dangerous! How does one design an experiment to prove that GM crops are not dangerous? When and who decides enough safety tests have been done. Scientists have done as much as their knowledge base permits to prove that GM crops are as safe as any other food available in the market place and the efforts will continue in keeping with the pace of technology development, but that does not seem to satisfy the critics. There is a plethora of scientific literature available and a bi-annual scientific biosafety meeting discusses some of the best research on the safety of GMOs. They keep assuring that GM crops are safe to the environment and to human and animal health, but the critics don't buy them. Instead offer their own spurious scientific evidences and flawed scientific arguments to prove that GM crops are unsafe. If one takes a serious look at the some of the criticisms of GM crops regarding their safety almost all their arguments are flawed in science, and it is hard to fathom why these critics continue to purvey such scientifically flawed or misguided arguments and to what end? There is a sort of "revisionist science" in the making just to jettison GM crops technology around the world. The worldwide web is full of them if one cares to read them. Most of the public have better things to do than to keep reading everything on the web these days, but some us who have innate interest in the subject keep track of them. By reading some of "their" literature and arguments, it becomes obvious that they have a modicum of scientific training and make believe that they know what they are talking about. They use many of the scientific jargons used by the scientists and have created some of their own to mislead the public. But, a closer scrutiny of what they are saying, it becomes clear that they turn and twist scientific facts, and grossly misinterpret them to scare the public. If one is honestly ignorant, or innocent, it should be possible to deal with them much more directly and inform them. But, how do you deal with people who are hell bent on misinterpreting scientific facts and mislead the public just to keep their activism alive? What gives them legitimacy is that the establishments in Europe and North America and now in Asia and Africa give them credence by acquiescing to their demands by instituting multi-million dollar programs to research safety questions related to GMOs and try to prove the negative, an impossible task indeed. Both North America and the European Union have spent literally hundreds of millions of dollars on biotech risk assessment research to prove the safety of GMOs, but to no avail. Now they say, you should repeat such kind of researches in Asia and Africa for decades to prove it to them that they may be safe. Clearly no amount of money spent on such red-herring research can all go a waste. Very many fundamental questions about safety, gene flow, out-crossing, and genetic stability and food and feed safety have been answered that hitherto had not been addressed. Also, many long-standing ecological questions have also been addressed as well. In sum, something good has come out of it. But, if you apply the cost-benefit analysis to that exercise, then it will come a cropper as precious dollars that should have been spent on much needed technology development and research capacity building around the world to tackle real problems have been squandered. But, be that as it may. I think risk assessment research must continue, but the critics must read the results of those projects and stop misleading the public about the GMO safety based on the high quality science used in them. Malapropisms What are the most common scientific malapropisms flaunted in the media and the public? It is commonly alleged that the introduced genes are leaky and therefore unstable alluding that genes will leak out of the GM plants and wreak untold havoc. The jargon "leaky" is used in a totally different context by molecular biologists to characterize the nature of gene expression. Second, they say introduced genes cause pleiotropic effects and scientists don't know what the hell is going to happen to the GM crops but conveniently ignore that it was the scientists who discovered pleiotropic effects of genes long ago, and know how to ensure that it does not affect the phenotypic expression of a selected trait by ensuring stable inheritance. There is something known as signal to noise ratio through which scientist screen and select the stably expressing lines. They seem to conveniently not mention that all the introduced varieties of crop plants have been rigorously tested by selection for stable inheritance of desired traits to bring it to the market place. Otherwise, can one imagine modern day seed companies selling seeds that do not perform what they are intended to be? Third, they say antibiotic marker genes render antibiotic chemotherapy useless by spreading into human and animal gut and other microorganisms. But, they will never tell the gullible public that if there is no selection pressure neither will there be a gene transfer nor do they express and that antibiotic resistance genes are already widespread in the environment. They will also not tell you that the same organisms that produce antibiotics also have developed resistance genes to protect themselves. What is important in gene transfer experiments in the gut is the frequency with which gene transfer occurs under what kind of selection pressure? They will never put this issue of antibiotic resistance marker genes in the overall context of a century old phenomenon called "antibiosis" that has been studied to death. But, they also do not distinguish between antibiotic producing genes and antibiotic resistance genes. Fourthly, there is this scientifically bogus phenomenon known as "genetic pollution" or "genetic contamination", a pure concoction of the GM opponents as if the genes are getting transferred for the first time now that GM crops are here. Using the words "pollution" and "contamination", you can scare away any innocent and ignorant public and rally support for their cause. They will never say the gene flow is an ancient trait of all living organisms throughout evolution and is the basis of speciation and biological diversity in the world. Fifth scientific malapropism that is flaunted is that modification of oil profiles in GM plants like canola will change the lipid profiles of cells (lipids, fats, and oils are one the same to them) and lipids are an important component of cell membranes. If you change the lipid profiles of cell membranes, they will develop big holes and drain out cell contents and the whole plant will be destroyed. On the face of it, it all looks plausible, but does it make any scientific sense that a modern day biotech seed company will try to market GM seeds that die off and can you imagine how one would bring such products to the market place? How can one sell such a seed whose progeny would have its entire cell contents drained out? It will be like visiting a boneless chicken ranch. The sixth malapropism is that "gene silencing" will somehow silence some important gene and cause untold effect in GM plants. The fact that "gene silencing" is one of the finely tuned gene regulation processes known so well in prokaryotes and has been discovered in tissue culture derived plants in the past 30 years. By discerning the basic mechanisms of gene silencing a brand new biotech industry is coming to the fore by using this powerful tool to tackle ever so many problems in biology. Practicing scientists know very well that the basic minimum requirement for gene silencing is sequence homology and whatever gene silencing that may occur happens only with the introduced gene only in a specific plant and it does not affect the entire field of GM crops, if at all. Gene silencing has never been recorded from a field of GM crops so far. But, who cares about the truth? The emphasis here is on the word "silencing" conjuring up an image killing a plant. Once again, when a stably inherited GMO is selected all these matters are taken care of. But, the critics would never want to study these things properly and convey proper information to the public as it odes not serve their purpose. For as long as golden rice has been in the news, anti-GM critics have been telling the world that people will have to eat 8 kilo grams of rice a day to get all the required daily doze of Vitamin A based on the miniscule quantity of Vitamin A produced from the very early construct of golden rice. When golden rice was first unveiled to the world, it was to provide a proof of concept that such complex metabolic genes can be successfully transferred to food crops, and such a technology can be exploited for the biofortification of staple food crops that do not provide adequate nutrition now. Is it really possible that scientists are so stupid to market a rice variety which people will have to eat in kilogram quantities daily to benefit from it? Is it not really absurd? Scientists deserve better credit than that. The fact of the matter is that there has been a fantabulous progress in the making of golden rice and iron rich rice that are now undergoing field tests, and soon very many other needed tests will be carried out before commercialization. This marvelous technological approach is now used in an international multi-million dollar biofortification research program funded by the Gates Foundation. The other scientific falsehood that is constantly propped up is that Bt Cry9c gene produces an allergenic toxin when in fact it has been investigated most thoroughly and found not to be so. But, they don't relent because if they accept scientific facts, they will have one less weapon in their armor to fight against GM crops. There is still a belief perpetrated by the anti-GM lobby that terminator genes will escape into the wild and sterilize biodiversity, a blasphemy to say the least. Recently, there has been a new allegation that hybrid crops of the green revolution are responsible for the development of super viruses that have now metamorphosed into SARS, HIV and mad cow disease. The fact that that line has been espoused by Nobel Laureate Maathai, it gives lots of credence to anti-GM lobby to use such scientific misinformation to their own end. There is also a sentiment against applying GM technology to medicinal plants and commercializing pharmaceutical transgenic plants not realizing that none of these plants are so sacrosanct that they cannot be researched upon using modern scientific approaches. It is already happening, and in fact, it makes eminent sense to understand the mechanisms of medicinal plants better so that we can manipulate them to produce their principal ingredients at will and don't have to destroy them for good in the nature. Imagine, taxol can now be synthesized, and one need not harvest the barks of the precious yew trees in the Himalayas. This is biodiversity conservation using modern biotech for you. Examples galore from chemical micro-array technology and metabolomics to get at ever so many naturally occurring medicines from plants, animals and microbes that can be synthesized either biologically or chemically and make them available at affordable costs to large populations. This is a constant quest of the scientists, and hat should continue. History of modern medicine is replete with so many examples of exploiting modern science to deliver health care. You will never see these anti-GM scientists present a paper of their "scientific" concern at a proper scientific forum where knowledgeable scientists can address them. Because, they know that their scientific malapropisms will not stand scrutiny. Instead, they hoist them on the gullible media who promptly purvey them without verification, as it sounds scientifically credible because they use some scientific jargons. There is no rhyme or reason to oppose GM crops based on good science. Underneath many of these specious arguments is deep-rooted ideological and political opposition to the modern biotechnology. But, the good news is that GM crops technology is taking root all over the world on its own merit. The opponents' last hope was Brazilian President Lula who they thought will stop GM crops technology. Instead, he just approved GM soybeans much against a world-wide campaign to stop him. Lula approved GM crops because he was convinced of the benefits of GM soybean based on facts and evidence and not rhetoric. We all have to keep repeating scientific facts, as we know as many times as the opponents of GM crops keep repeating their scientific lies. Otherwise, there is a real danger of this beneficial technology either delayed or not reaching those who need it the most in the developing world. The scientific community in the developing world must wake up to counter this non-scientific propaganda against biotechnology and directly communicate with the public and the media to present scientific facts to promote safe and effective deployment of biotechnology. Dr. Shanthu Shantharam is the President of a biotechnology affairs consulting firm, Biologistics International in Maryland, USA. ]]> <![CDATA[Praj commissions biomethanation plant in UP, consolidates overseas business]]> https://biospectrumindia.com/news/95/2556/praj-commissions-biomethanation-plant-in-up-consolidates-overseas-business.html https://biospectrumindia.com/news/95/2556/praj-commissions-biomethanation-plant-in-up-consolidates-overseas-business.html Tue, 05 Oct 2004 10:31:00 +0530 Praj Industries has successfully commissioned a biomethanation plant based on Ecomet-XT (MTR technology) at Balrampur Chini Mills (Babhnan unit) in Uttar Pradesh. According to company officials, the plant can generate more gas from the same feed as compared to the conventional technologies. Further to tap the markets in Central and South America and in the Caribbean, Praj has set up a separate project office, which will become operational from this month. Since January 2004, Praj has bagged five orders from different sugar mills in Colombia for installation of ethanol plants. Besides Colombia, Praj has bagged significant orders from Australia and Thailand. Praj won a contract for a 140,000-liters per day grain distillery plant from Australian Biofuels Pty Ltd (a subsidiary of INDCOR). The plants design can facilitate the use of various types of grains available in that region as feed. It also has contract from Khon Kaen Alcohol Company Ltd (KSL) of Thailand for an ethanol plant based on cane molasses and cane syrup for production of gasohol. The 100,000 liters per day distillery is attached to the Khon Kaen sugar mill located at Nampong in Thailand. Medispec to distribute Wealtec products Medispec Instruments India Ltd (MIIL) has entered into an exclusive distributorship agreement with Wealtec Corp. of the US to market the latter's Dolphin series of gel documentation systems in India. Its product range includes Dolphin-view, a standalone system; Dolphin-doc, a standard unit for image capturing; Dolphin-chemi with peltier cooled CCD camera for chemilumiscence; and Dolphin scan systems and powerful dolphin 1d image analysis software. MIIL, an ISO certified organization, has over the past five years established itself strongly in the gel-doc systems market and considers this relationship will further help it to consolidate its position in the market place. Vipul Chhatbar, managing director, MIIL informed that Wealtec's products will be available as exstock in easy local currency and help customers save on long wait after placing order and cumbersome import procedures. Cambrex introduces protein delivery reagents Cambrex Bio Science Rockland Inc., a subsidiary of Cambrex Corp., has announced the availability of the Passport Protein Delivery Reagent, a tool for non-cytotoxic delivery of biologically active cargo molecules such as proteins, peptides, or small molecules, directly into living cells. The reagent provides easy methods to study cell and protein function, while avoiding the problems of DNA transfections. Several cell lines and primary cells have been transfected with the Passport Reagent, including human bronchial epithelial cells, human epidermal keratinocytes, aortic smooth muscle cells, HUVEC and human dermal fibroblasts. Kendro acquires H+P Labortechnik Kendro Laboratory Products has strengthened its commitment to growth in the life science market with the acquisition of H+P Labortechnik AG. H+P is a company that provides sterilizers, high performance stirrers, and biosafe wastewater sterilizers. "H+P has a premier product position with a high quality image and many loyal customers resulting in a strong complementary fit to the brands and image of Kendro," said Dennis M Pope, president, Kendro. Following the acquisition, Dr Helmut Herz, founder of H+P, will be the managing director of the new organization, while Pope will be chairman of the H+P management board. Alfa Laval acquires Biokinetics Alfa Laval has acquired Biokinetics, the life science division of the Kinetics Group Inc. in the US. Biokinetics is an engineering and turnkey process systems provider and its primary product focus is on bioreactor modules, cell harvesting modules, purification modules and biodeactivation modules. The acquisition will allow Alfa Laval to combine Biokinetics resources with Alfa Laval's global presence and move into the European and Asian markets. The combined offering will include process design, modules for unit operations and key components such as high-speed separators, compact heat exchangers, membranes, fluid handling equipment and parts and service. Biokinetics was part of the US Filter Corp. till August 2000, when it was taken private in an investor-led buyout. Biokinetics, which has approximately 400 employees, is headquartered in Philadelphia and has facilities in North Carolina, California, Puerto Rico and Toronto. VARDA Biotech scouts for JVs Mumbai-based VARDA Biotech is looking actively to tap new joint venture and research partnership opportunities. The company is into strategic souring, contract manufacturing, custom synthesis, chiral synthesis and clinical research services, besides product development. Its product portfolio in biotech includes Taq DNA polymerase, neuro science products, hormones and enzymes, and lacto bacillus sporogenes. And in the pipeline are other products like Klentaq DNA polymerase for application in the diagnostic, forensic, clinical and research laboratories, DNA markers, Lysostaphin, etc. VARDA is an ISO 9001:2000 certified company and has several strategic alliances for product association and representations. Thermo Electron acquires InnaPhase Corp. Thermo Electron Corp., a global leader in analytical instruments, has completed the acquisition of InnaPhase Corp., a premier supplier of Laboratory Information Management Systems (LIMS) for approximately $65 million in cash, subject to a post-closing adjustment. Headquartered in Philadelphia, InnaPhase has over 100 employees and expects revenues of approximately $26 million in 2004. With this acquisition, Thermo extends its position as the largest provider of LIMS products and services in the world. InnaPhase's flagship Watson LIMS is the leading product in drug development laboratories and the industry standard for bioanalytical applications. InnaPhase's products will be integrated with Thermo's informatics product line, which includes SampleManager, the leading LIMS for large analytical laboratories. "The InnaPhase team brings deep industry expertise and world-class software development capabilities," commented Marijn E Dekkers, president and CEO, Thermo Electron Corp. PerkinElmer, Vivascience tie-up for biomarkers PerkinElmer Inc., a provider of drug discovery, life science research and analytical solutions and Vivascience AG, a supplier of products and technology solutions for protein purification and analysis and member of the Sartorius Group, have entered into a collaborative partnership and distribution agreement for biomarker screening and discovery. Under the terms of the agreement, Vivascience will supply its patented membrane adsorber chromatography technology for capturing biomarkers to PerkinElmer. PerkinElmer will then combine the technology with its proprietary methods for elution to create fractionation and biomarker sample preparation kits. The kits will be integrated with PerkinElmer's automated platform for biomarker screening, which includes the MultiProbe II for automating the kits and the prOTOF 2000 MALDI O-TOF mass spectrometer for detecting the biomarkers. "By working with Vivascience and taking advantage of both proven technologies and new developments across multiple product platforms, PerkinElmer's enhanced capabilities in biomarkers will bring substantial benefits to the customers we serve," said Peter Coggins, president, PerkinElmer Life and Analytical Sciences. Applied Biosystems, MDS expand JV Applied Biosystems Group and MDS Inc. have signed an agreement to expand the scope of their joint venture in life science mass spectrometry. According to the agreement, MDS will pay $40 million for a 50 percent interest in intellectual property assets related to current Applied Biosystems MALDI Time-of-Flight (TOF) mass spectrometry systems and next-generation products under development, together with a 100 percent interest in certain MALDI TOF product-related manufacturing and research and development assets. The Applied Biosystems Group develops and markets instrument-based systems, consumables, software, and services. MDS Inc. provides enabling products and services for the development of drugs and the diagnosis and management of disease. MDS Sciex is the analytical instrumentation and technology solutions division of MDS Inc. John A Rogers, president and CEO, MDS Inc. said, "The expansion of the joint venture will allow us to combine two highly capable research groups into one and will allow us to move forward in a more integrated way in MALDI TOF products and in the proteomics arena." Waters ships new liquid chromatography products Waters Corp. has announced shipment of its ACQUITY Ultra Performance Liquid Chromatography (UPLC) instrument. UPLC is considered by many to be the next big thing in Liquid Chromatography (LC). Waters is understood to be the first company to introduce an end-to-end UPLC system offering specially designed column chemistries, hardware, software, and user documentation. "The aspects that scientists like best about UPLC are that the principles of the separation are identical to liquid chromatography and that the chromatographic performance is significantly better," stated Art Caputo, president, Waters Chromatography Division. The product is claimed to be the first-of-its-kind LC system designed to take full advantage of the potential of proprietary, sub two-micron particles to give scientists chromatographic run times that are up to 9X shorter than today's fastest HPLC systems, up to 2X better peak capacity or resolution and 3X better routine sensitivity. ACQUITY UPLC has been heralded as the most significant new LC product introduction in more than 30 years and it has received the coveted Pittcon Editor's Gold Award for best new product at Pittcon. GE Healthcare offers whole genome bioarray GE Healthcare, the combined entity of Amersham and GE Medical Systems, has announced the addition of a rat whole genome bioarray to its CodeLink microarray platform portfolio. With approximately 34,000 gene targets, the CodeLink rat whole genome bioarray is touted to provide the highest available content of any commercially available rat microarray on a single chip. It enables researchers detect genes expressed at ~ 0.3 copies per cell or 1:1,000.000. This product is the first in a series of planned whole genome bioarrays from GE Healthcare. The mouse whole genome bioarray is scheduled to be launched later this year. Sigma-Aldrich, Caliper to work together on genomics Sigma-Aldrich Corp. and Caliper Life Sciences have announced that they would develop and co-market a series of automated turnkey solutions for a wide variety of applications in genomics, proteomics, and drug discovery. The two companies will develop a series of pre-optimized and validated automation protocols using Caliper's Sciclone ALH 3000 liquid handling workstation with a variety of Sigma-Aldrich's biochemicals and reagent kits. The first kits to have been automated include Sigma's Extract-N-Amp Blood and Tissue kits for the rapid extraction and subsequent amplification of genomic DNA from blood and animal tissues and HIS-Select Integrated Lysis and Purification (iLAP) plates, a platform for purifying recombinant proteins. "Caliper Life Sciences, with its advanced liquid handling and LabChip technologies, is clearly on the leading edge of innovation when it comes to developing tools to accelerate drug discovery and basic research," commented Keith Jolliff, global strategic marketing manager, Sigma-Aldrich. "By combining Sigma-Aldrich's innovative molecular biology and proteomics kits with Caliper's strength in automation, we will be able to deliver true walk-away solutions to the research community," Jolliff said. DPC, Compugen to collaborate in diagnostics Diagnostic Products Corp. (DPC), a global provider of immunodiagnostic systems and reagents, has entered in to a broad diagnostic collaboration with Compugen, a genomics-based drug and diagnostic discovery company. The thrust will be on the development and commercialization of novel diagnostic products. According to the agreement, DPC can develop and commercialize immunoassay and nucleic acid-based diagnostic products based on Compugen discovered biomarkers, including certain biomarker candidates already discovered by Compugen, as well as additional candidates arising out of the collaboration. The unique discovery capability underlying this collaboration is provided by Compugen's discovery engines. Compugen is entitled to receive development milestone payments and royalties on the sales of the diagnostic products. In the cases like where discovered proteins may have therapeutic applications, Compugen will have the right to pursue further development in this field and DPC will be entitled to milestone payments and royalties from any successful therapeutic applications. "We are enthusiastic about the opportunity to assess multiple high quality diagnostic biomarkers that have been discovered by Compugen," said Michael Ziering, president and CEO, DPC.   ]]> <![CDATA["The Indian market potential is much higher than what we heard from out side,"`]]> https://biospectrumindia.com/news/95/2289/the-indian-market-potential-is-much-higher-than-what-we-heard-from-out-side.html https://biospectrumindia.com/news/95/2289/the-indian-market-potential-is-much-higher-than-what-we-heard-from-out-side.html Tue, 05 Oct 2004 10:30:00 +0530 Craig Jack, president, Nalge Nunc International It was for the first time that Craig Jack, president of the US-based Nalge Nunc Interational (NNI) visited India. NNI is one of the leading players in the global labware market and its products have been there in the Indian market for more than a decade through Genetix. In an exclusive interview with BioSpectrum, Jack shares his feedback about the Indian research market. His first actual experience interacting with the Indian biotech research industry was very interesting and seems full of prospects, he narrated. W hich market segment would be your business priority here? India is shaping up to become the hub of biotech activity in the region. There has been a lot of activity in biopharma research. And the Indian pharma industry is poised to take a good ride on the biopharma industry. Further, business is also moving at a high pace in this direction. So we are looking at this segment quite aggressively. What was the basic agenda of your much-awaited business trip to India? The primary purpose of this trip was to explore the market. After hearing a lot of things about this market, we were very curious to peep into India for strengthening the business. I would like to comment that the Indian market potential is much higher than what we heard from out side. I covered almost all the regions of India including the North, South and West-which I see as the most vibrant. What are your plans for India? We are committed to the Indian market very religiously and are satisfied with the business relationship with Genetix Biotech Asia Pvt Ltd (Genetix). So, we are looking forward to sustain such good relations with our Indian marketing partners, Genetix. As regards to further strengthening of our presence, we have visited the industry and explored some hot areas within India. Now I have to submit my report to my senior coleagues and only then we can say anything. Customization is the order of the day. Are you contemplating offering customized products here? Yes, we have plans to offer customized products that would cater to the needs of the Indian researchers. For doing this, we always keep on interacting with our customers, getting their feedback on our products. Genetix is doing a great job for us. How big is your business from India? A major chunk of our business comes from the US market. It accounts for nearly 80 percent of our total business. The rest comes from outside the US market. The Asia-pacific region contributes to about 10 percent of the total business. Though the percentage of Indian business is lesser in such a scenario, we expect a good growth in the coming years. As per business reports, the Indian biotech research market is expected to double its revenues in the next two to three years. Faiz Askari in New Delhi   ]]> <![CDATA[The Father of Rice Revolution]]> https://biospectrumindia.com/news/95/2791/the-father-of-rice-revolution.html https://biospectrumindia.com/news/95/2791/the-father-of-rice-revolution.html Tue, 05 Oct 2004 10:25:00 +0530 Dr Gurdev Singh Khush Dr Khush is one of the global leaders on crop breeding and a major brain behind the development of productive rice varieties and the Green Revolution in plant breeding. Born in the village of Rurkee in Punjab, this son of a farmer finished his Bachelor of Science from Punjab Agriculture University and went to University of California, Davis, to do his PhD. He in fact worked as a laborer in a canning factory in England to earn his money to go to America. At the age of 25, Dr Khush completed his PhD in genetics in less than three years after joining the University of California. In 1967, Dr Khush joined the International Rice Research Institute (IRRI), Manila and he was there till 2000 and since the past few years he has been with University of California, Davis, as adjunct professor. Dr Khush, who joined the IRRI after postdoctoral studies on tomato breeding, became principal plant breeder and head of the Plant Breeding, Genetics, and Biochemistry Division, and took IRRI to the vanguard of developing 300 new rice varieties and trigger the green revolution in Asia. Dr Khush may not be a household name. But his rice varieties touch the lips of every person in Asia. In the last 35 years, he and his team at IRRI in Manila introduced several varieties like IR8, IR36, IR64 and IR72. IRRI rice varieties and their progenies are planted in over 70 percent of the world's rice-fields. The rice production around the world in 1966 was close to 257 million tonnes and today it has increased to over 700 million tonnes. Thanks to Dr Khush and IRRI. In less than five years of joining IRRI, Dr Khush became the head of IRRI's plant breeding department and had developed his own new variety of "miracle rice", IR36. This was developed using IR8 as a genetic base and cross breeding it with 13 parent varieties from six nations. IR36 is a semi-dwarf variety that proved highly resistant to a number of the major insect pests and diseases. Further, IR36 matures rapidly in about 105 days compared to 130 days for IR8 and 150-170 days for traditional types and produces a slender grain that is preferred in many Asian countries. The combination of these characteristics soon made IR36 one of the most widely planted food crop varieties the world has ever known. However, it was not an easy acceptance though. According to Dr Khush the farmers were initially skeptical about IRRI's new grain varieties. It took almost 25 years for Dr Khush's rice initiative to see excellent results. The rice production doubled to 518 million tonnes in 1990. According to IRRI estimates, IR36 has added about 5 million tonnes of rice annually to Asia's food supply and accounts for an additional $1 billion yearly income to Asian farmers. IR64 later replaced IR36 as the world's most popular variety and IR72, released in 1990, became the world's highest-yielding variety. In 1994, Dr Khush announced a new type of "super rice", which has the potential to increase yields by 25 percent. His final work on what is called the New Plant Type (NPT) for irrigated rice fields is complete. Developing NPT almost took 12 years and the plants were yielding strongly in temperature areas of China and are expected to be ready for farmers in tropical Asia in 2005. It is a complete redesign of the rice plant from the roots up, making it higher yielding, more vigorous, and better able to resist pests and diseases without the use of environmentally damaging pesticides. It is designed to yield up to 12 tonnes per hectare in irrigated tropical conditions, but adjusting its genetic characteristics to match tastes and environment conditions. "When Gurdev Khush first started to develop rice varieties 34 years ago, there were few countries in Asia with the research infrastructure to work with him to adapt new varieties to local conditions," said former IRRI director general and ex-officio member Ronald P Cantrell in one of the Annual General Meetings. "But now, almost every Asian nation has some level of agricultural research capacity." Because of this, Asian countries have been able to feed their growing populations and, for the most part, maintain peace and stability. "The true Asian miracle through the 1970s and 1980s wasn't stunning economic growth. It was keeping people fed and societies relatively stable," Dr Cantrell said, "And now, with the new plant type ready for farmers' fields, we are hopeful of being able to maintain this level of progress." Dr Khush is one of the most decorated scientists in the world, winning the Japan prize in 1987, the World Food Prize in 1996, the Wolf Prize from Israel and the Padma Shri Award from the government of India in 2000, and the China International Scientific and Technological Cooperation Award for 2001. The World Food Prize, widely regarded as the equivalent of a Nobel Prize for agriculture, is awarded by the World Food Prize Foundation based at Des Moines (USA), which he won for his contribution to "advancing human development by improving the quality, quantity or availability of the world's food supply." It cited that the increased availability of rice has not only lowered costs to consumers but also enhanced the nutrition of millions of people. Caloric intake in almost all Asian nations has improved. For example, caloric intake in Indonesia increased from 81 percent of the daily requirement in 1965 to 120 percent in 1990. And all of this happened while the population of rice consumers was growing by more than two percent annually, and the availability of rice production land remained stable. "GM Crops Can Contribute In Several Ways," asserts Dr Gurudev S Khush The BioSpectrum series on Biotech Gurus continues with Dr Khush who has joined the pantheon of eminent scientists from India who have made the world their home. Dr Khush was in Bangalore as a keynote speaker at Bangalore Bio in July this year. N Suresh and Ch. Srinivas Rao caught up with him to know the importance of bioagri products. Excerpts from the interview. How important are GM crops? I think GM crops can contribute in several ways. One is in introducing durable resistance to diseases and insects. That's very important and that's where the progress has been made until now. The second area is developing the crops, with drought tolerance and salinity tolerance and what we call the tolerance to abiotec stresses. Thirdly, GM crops can contribute to the improvement of the nutritional quality like improvement of vitamin A, iron and zinc content. The fourth area is the improvement in the yield potential. This is going to be the most difficult. So the progress is more in diseases and insect resistance crops, the drought tolerance is coming and in the nutritional content, we have the vitamin A rich rice and the yield potential is going to come later. But there is stiff opposition to GM crops ... I think it is just that the public has been so much confused with this anti-GM propaganda. They don't look at things in the right perspective and the average people read the information and cannot understand and sort out the science of the GMOs. So the public is generally confused. But if you see the records, there are 67 million hectares of transgenic crops grown world over and they have been consumed. Nobody has even had a stomach ache and nobody has had an adverse effect. So my answer is they should be properly regulated, biosafety tests done properly for food safety and environmental safety and if they are found to be safe, then we should go ahead and release these crops and consume them. How can the industry counter this opposition? If you are worried about the risk, then you can't release any technology. Why are you driving cars? Anybody can get killed on the roads. If you are worried, you can't release any pharmaceutical. How do we know what this pharmaceutical can do after 20 years? We may sometimes find that one of these pharmaceuticals had some side effects. If you think of any technology, which has happened in the last 20 years, nothing could have been released if we did not take the risk. How can the industry get this message across to the public? This is a problem. I am going to say a few words on that. There was a meeting at the Royal Society and they invited some people from the media, from science groups and from NGOs and the feeling was that the scientists should be more proactive and that they should talk to the media and the media should give out the right kind of information. So, I think, we have to get this idea across as most of the general public is confused about this. The scientists must develop skills to communicate with the media and public. The public must be able to recognize how scientific process takes place and understand relative risks. The governments should be involved in regulating the application of science but should not be a stumbling block. Is the opposition to GM crops largely because the crops have been released mostly by giant multinational companies rather than public companies? I think the agenda of the anti-GM group is to go against all this and criticize it whether it is released by the public sector groups or the private sector. So I don't think that's going to make too much of a difference. What are the major challenges facing both global and Indian agriculture? The challenge for the Indian agriculture is to produce more food. Although, we seem to be in a good shape now, you see there are 250 million people who go to bed hungry everyday. If they have the purchasing power, then we will have a shortage of the food situation. And our population is increasing at a fast pace. We are adding 18 million people every year. So the food production must continue to increase at about the same rate. Otherwise we will run into problems that we had in the 1950s and 1960s. Further investments in irrigation has virtually ceased and good land is being lost to industrialization. If present trends continue, it will not be possible to meet future demand for food. GM crops will be helpful here. We can use both conventional methods as well as the biotechnology. Both should be used, wherever there is application. Globally there is a lot of work going on. The food security seems to be adequate. Only developing countries have some problem but most of the European countries have got good food security. What is the status of the global agricultural production? It has slowed down. It's not as good as in the 1970s and the 1980s. The rice grain and wheat were increasing at the rate of 2.5 percent in the 1970s, by 1980s this was down to 2 percent and in the 1990s it was down to 1 percent and it is now 1percent or less than 1 percent. So the rate of increase has declined primarily because the steam out of the green evolution has run out.       ]]> <![CDATA[Indian researchers discover a new anti TB molecule]]> https://biospectrumindia.com/news/95/2173/indian-researchers-discover-a-new-anti-tb-molecule.html https://biospectrumindia.com/news/95/2173/indian-researchers-discover-a-new-anti-tb-molecule.html Tue, 05 Oct 2004 10:23:00 +0530 In a joint public-private partnership project between the Council of Scientific and Industrial Research (CSIR) and Lupin laboratories Mumbai, researchers have discovered a new anti-tubercular molecule for the treatment of tuberculosis (TB). This development has enthused the entire research community as the molecule, LL 4858-SUBOTERN, has the potential to not only treat tuberculosis effectively but also reduce the treatment time significantly. The Institutional Partners 1. International Centre for Genetic Engineering and Biotechnology (ICGEB), New Delhi. 2. Bose Institute (BI), Kolkata 3. Central Drug Research Institute (CDRI), Lucknow 4. Centre for DNA Fingerprinting and Diagnostics (CDFD), Hyderabad 5. Indian Institute of Chemical Technology (IICT), Hyderabad 6. Indian Institute of Science (IISc), Bangalore 7. Institute of Genomics and Integrative Biology (IGIB), New Delhi 8. National Chemical Laboratory (NCL), Pune 9. National Institute of Immunology (NII), New Delhi 10. Regional Research Laboratory (RRL), Jammu 11. University of Hyderabad Lupin Laboratories, Mumbai, partnered with CDRI, NCL, IICT and University of Hyderabad in achieving this breakthrough.   Announcing the breakthrough, Kapil Sibal, minister for science and technology, said, "This is the first success achieved in developing a new therapeutic molecule for tuberculosis since the last discovery of Rifampicin in 1963. All over the world, work has been going on to reduce the TB treatment time from the current level of six to eight months and there has been no success. The Indian breakthrough makes it possible by clearing the total infection in two months only." The molecule, which works through combination therapy, is compatible with the present drugs, is less toxic and can prevent the recurrence of disease. It fits well into the present four-drug therapy by replacing one or two drugs from the present cocktail. Significantly the new molecule is also effective against multi-drug resistant strains of tuberculosis. The genesis This success story can be traced back to 2001, when the CSIR through the New Millennium Indian Technology Leadership Initiative (NMITLI) scheme supported the project entitled "Latent M. tuberculosis: New targets, drug delivery systems and bio-enhancers and therapeutics". The objectives of the project were to improve current treatment by shortening total duration of treatment and address the problems of multi-drug resistance and latent tuberculosis infection. In order to achieve these objectives, a three-pronged strategy was employed viz. development of new drugs including identification of new targets, new drug delivery systems and application of bio-enhancers as an adjunct to chemotherapy. A network of 11 leading CSIR research institutions and Lupin as industrial partner in "public-private partnership" mode was put in place to achieve these objectives. Lupin invested about Rs 11 crore and CSIR put in Rs 9 crore in the project. Along with the Central Drug Research Institute, Lucknow, the Indian Institute of Chemical Technology, Hyderabad, the National Chemical Laboratory, Pune and the University of Hyderabad, Lupin was involved in the designing and synthesis of the new molecule, whereas seven other institutes were engaged in research on bioenhancers and identification of new targets The regulatory studies on the new pharmacophore have been completed and the molecule has been tested on mice and guinea pigs and proved to be highly effective. An Investigational New Drug (IND) application running into 2903 pages has been filed. Once the IND is cleared by the Drugs Controller General of India (DCGI), the molecule will undergo phase I, II and III clinical trials in human subjects. These trials are expected to take about four to five years and if they are successful, the new drug will be introduced into the market. Rolly Dureha   Important tree genes mapped Researchers in Sweden and the US have released a new database of many of the important genes in a tree genome. This collection of genes includes a large proportion of those expressed during tree growth. Just as Arabidopsis is the most commonly studied plant in the world with respect to molecular genetics, poplar is the most commonly studied tree. The database describes about 102,000 sequences of the most commonly expressed genes in the genus Populus, which includes cottonwoods and aspens. In living organisms, the genes that are "expressed" are only a fraction of the total DNA in cells. But they are most important to determining an animal or plant's function-in the case of a tree, forming its bark, leaves, roots and wood and enabling it to respond to environmental stresses. The database was produced by a research group in Sweden with collaboration by researchers at Oregon State University (OSU). The study also compared many of these gene sequences to those found in Arabidopsis, and found that nearly all the genes were functionally common between the two, even though they have been separated by about 100 million years of evolution and look completely different. Arabidopsis is the most frequently used plant in the world for basic genetic research on plant structure and function and being able to compare its genetics to those of a tree is expected to speed genetic research with trees. According to the researchers, this also indicates that the large majority of transfers of genes between widely separated plant species via genetic engineering would not produce novel characteristics, but simply modify existing genetic characteristics. "There is still an enormous amount we do not know about the genetic function of trees at the most basic levels, but advances such as this will narrow the gap between the scientific research we can undertake with trees and the studies that are possible with traditional model plant species, such as rice, corn, and Arabidopsis," said Steven Strauss, a professor of forest science at OSU. Trees, which are among the most ancient of plant life forms, also have a very complex genetic makeup that so far has resisted many of the traditional genetic research techniques that are used with other plants, which have short life cycles. The new study, along with advances that are expected soon to describe the entire Populus genome DNA sequence, will help scientists find specific genes in a matter of minutes using computational approaches. "Such discoveries would take decades or centuries prior to these databases. Once you know a lot of gene sequences and can study thousands of genes at a time, you can start to really explore how trees might respond on a basic genetic level to such stresses as drought, exposure to cold, and pest attack," said Strauss. Ultimately, the researchers believe that a more comprehensive understanding of tree genetics should allow controlled gene transfer, both as a research and biotechnology tool. Source: Oregon State University Vanillin may treat sickle cell disease Vanilla, a popular ice cream flavoring, fudge and cake-frosting agent, may have potential uses as a medicine. Recent laboratory research has indicated the possibility that a form of vanilla may become a drug to treat sickle cell disease. This was concluded after experiments in which specially bred mice received a compound that turns into vanilla in the body, survived five times longer than mice that did not receive the chemical. All the mice were subjected to low oxygen pressure, a condition that causes their red blood cells to form the hazardous sickle shape. Results of the study, led by research hematologist Toshio Asakura, of The Children's Hospital of Philadelphia, have appeared in the June 2004 issue of the British Journal of Haematology. It had been known for 30 years that vanillin, the compound that gives the vanilla bean its flavor, protects red blood cells with sickle cell disease. However, this effect previously occurred only in test tubes, because vanillin normally breaks down in the digestive tract before reaching the bloodstream. Scientists at Medinox, a San Diego-based biotechnology company, developed a variant of vanillin called MX-1520, chemically modifying it to resist degradation by the digestive system. MX-1520 is a prodrug-a compound that becomes an active drug (in this case, vanillin) in the body. Dr Asakura and his team tested MX-1520 in transgenic sickle mice-animals with red blood cells containing human sickle hemoglobin, similar to the defective blood cells in people with sickle cell disease. The researchers found that most of the MX-1520 turned into vanillin in the mice, where it interacted with sickle hemoglobin and inhibited the formation of rigid sickled cells. A gene mutation causes red blood cells to become stiff and sickle-shaped, damaging and obstructing blood vessels. The disease may cause severe pain, stroke, anemia, life-threatening infections, and damage to the lungs and other organs. "The results of the study indicate that further study of the vanillin prodrug MX-1520 is warranted, but the compound has not yet been studied in any patients. Patients with sickle cell disease should also be aware that this study does not imply that eating food products currently containing vanilla will benefit patients, because most vanilla is destroyed in the stomach and does not reach the bloodstream," said Dr Asakura. Source: The Children Hospital of Philadelphia             ]]> <![CDATA[Clinical Trials, A Peanuts Business: Vasireddi]]> https://biospectrumindia.com/news/95/1765/clinical-trials-a-peanuts-business-vasireddi.html https://biospectrumindia.com/news/95/1765/clinical-trials-a-peanuts-business-vasireddi.html Tue, 05 Oct 2004 09:59:00 +0530 Dr SP Vasireddi Dr SP Vasireddi, chairman and managing director, attributes the success of the company to team effort and vision. He strongly believes in turning adversities into advantages. CyberMedia News caught up with him in a brief chat to voice his opinion on the status quo of clinical contract research activity globally and the role of India. What's the focus of Vimta Labs? Vimta has been the leader in the fields of chemical, biological, and mechanical testing and validation of various materials. The present focus is on research and testing of water, food and agri-products, nutritional labeling and drugs and pharmaceuticals. When Vimta was started in 1984 with contract testing facility, it was then an evolving activity and so we maintained R&D in different segments. And when we moved to our present facility at Cherlapalli (Hyderabad) in 1992, we focused on biological testing. Today, we are looking more at health elements like water, food, drugs and clinical testing. We have consolidated our operations. It was started with focus on almost all the sectors of the industry. But today, we are focusing on important sectors and importantly we are dealing with comprehensive contract research and testing services. Currently, what are the areas that you are working on? What are your plans in the near future? We are concentrating more on the life sciences activity. Molecular biology is one key substitute. For clinical research, we are using several molecular biological testing. We are the first to offer neonatal screening service commercially a year ago. And we would be offering more such genomic features in the days ahead. But most of the laboratories in our country are not really designed to conduct this type of tests, as we need bio-safety levels I, II and III. We can't alter existing facilities and carry on the operations. Keeping this in view, we are now constructing a facility in SP Biotech Park, Genome Valley, Hyderabad. The 160,000 sq. ft. facility with an investment of Rs 40 crore would be ready by April-June 2005. The lab with its 24/7 operations would accommodate 300 employees per shift. Addressing all biological safety requirements, the building would be fully automated and energy efficient. Also, the molecular biology lab at TICEL Biopark in Chennai is ready for commencement of the operations. This would primarily extend support to occupants in the biopark. What are the key bottlenecks you are facing as an industry? I don't buy the theory that there are too many bottlenecks in the industry. One has to take risks and overcome hurdles to attain success. However, quality and price is a hurdle. Quality can't come at a cheaper price. But this is evolving as volumes and technology are making it easier. With increase in volumes, the process costs could be absorbed and the benefits can be passed on to the customer. Equally, technology is contributing by less usage of manpower and fast access. India is said to be emerging as the new destination for clinical trials. How real is this view? It's an unnecessary hype on clinical trials prospects. A simple analysis based on commonsense can prove this. The US market for the year 2003 is about $10.7 billion. And what cost advantage does India have for clinical trials? Some predict it to be 50 per cent, some 70, 80 and so on. Even if we assume that the rest of the world stops contributing, India's amount could sum up to less than $5 billon. But why will the existing players stop their functions? Assuming that we are exceedingly doing well and if a miracle happens then we can do at the most $1 billion. Clinical trials itself is a peanuts business and globally it's a monopoly market. The top five CROs themselves contribute 54 per cent of the total market share. Of the rest 46 percent, 63 percent of the revenues are shared by third world countries like India that has a market size of anything between $1-3 billion. It's doubtless that the rest of the world has to close down so that India will twinkle as the new destination for clinical trials. What are the reasons that are hindering the forward movement of India as the new destination for clinical trials? Reasons are many. Independent committees are still to be registered in our country. There is no national monetary mechanism. Regulations are yet to become favorable for conducting phase I, II and III trials. Besides, uninformed patient pool, naÃ¯ve insurance companies, which are not ready to offer all the professional coverage's are few others. There are so many issues and everything boils down to environment factor. And when we talk of future, we are talking about the next three-four years or maximum of five to seven years. Keeping the above factors in view, I don't see a glorious opportunity for clinical trials. Further, it is being touted as Maharashtra emerging as a clinical trials hub. Do you intend to move there? These are all proprietary statements. I don't want to make it controversial. Everyone has their own claims but as I was mentioning earlier that clinical trials itself is a peanuts business. Considering this, where does the question arise of Maharashtra being a hub? It's awkward to talk on such statements. What is the cost arbitrage involved with clinical trials and contract research testing in India? Most global CROs have Phase III trials as their core business. A phase III clinical trial involves anything not less than 500-1000 patients and could cost Rs 50 lakh to Rs 1 crore or more with about 30 percent margins. The Indian drug controller does not allow Phase I and Phase II trials unless the molecule had been developed here. Now considering that Indian clinical CROs get a project for Phase III trials for about Rs 1 crore, how can Indian clinical trials market reach the touted billions target? There are several companies like Elli Lilly etc, which are doing a lot of contract research. How do you foresee the opportunity and competition from such companies? They are all established global players. They have efficient systems in place and they know what they are doing. They have their own programs above all. We are third party CROs and they are not our competitors. How has your business grown in the last few years? We have a long-term vision to be one among the top 10 contract research and testing organizations globally by 2010. In an effort to reach our ambitious goal, we are targeting aggressive growth rates. Our 80 percent Compounded Annual Growth Rate (CAGR) in the last financial year exemplifies this. Sunitha Natti, CyberMedia News, Hyderabad ]]> <![CDATA[Affordable Immunity With Superior Technology]]> https://biospectrumindia.com/news/95/1324/affordable-immunity-with-superior-technology.html https://biospectrumindia.com/news/95/1324/affordable-immunity-with-superior-technology.html Tue, 05 Oct 2004 09:57:00 +0530 Indian Immunologicals From being a single-product vaccine manufacturer for Foot and Mouth Disease (FMD) to a larger biologicals manufacturer, Hyderabad-based Indian Immunologicals Ltd (IIL) has come a long way. With a quest for affordable immunity, its commitment towards world-class quality products at viable prices is evident enough. A veterinary vaccine leader, IIL now provides a wide array of human and animal products. "Earning profits alone is not our performance criteria," says KV Balasubramaniam, managing director, Indian Immunologicals Ltd. The company believes in making reasonable profits and creating surpluses and fuelling it back for research purposes. Set up by National Dairy Development Board (NDDB) in 1983 with the objective of making FMD vaccines for farmers at very affordable prices, IIL today operates the largest plant in the world for veterinary vaccines. Its plant at Hyderabad has an installed production capacity of over 25 million quadrivalent doses of FMD vaccine. With total revenues of Rs 67 crore for the year ending 2003-04, IIL would easily be amongst the top 10 animal health companies in the world and the largest exporter of veterinary biologicals in Asia. The company's total exports in 2003-04 stood at Rs 5.14 crore. It is believed to be the only veterinary biological unit in India to obtain both ISO 9002 & Good Manufacturing Practices (GMP) Certification as per World Health Organization (WHO) GMP guidelines. Following the successful introduction of FMD vaccine-Raksha, IIL later launched the tissue culture rabies vaccine "Raksharab" and Theileriosis vaccine Rakshavac-T in 1989. In fact, IIL is credited to be the first Indian company to make tissue culture rabies vaccine. Subsequently, it developed many biologicals through its own R&D work and launched several vaccines in the Indian market at affordable prices. Expansion "With a facility in Ooty to manufacture Vero Cell Culture Rabies Vaccine, IIL enabled the country to phase out the use of older and unsafe sheep brain vaccine (also termed as nerve tissue vaccineâ€“NTV) and replace it with the modern tissue culture vaccine, Abhyarab," informed Balasubramaniam. It is the second company in the world to launch the Purified Vero Cell Rabies Vaccine (PVRV). Priced at Rs 200 per dose, this is sold through its network of 1500 "Abhay Clinics" and is claimed to be about 35 percent cheaper than the brands marketed by multinational companies. IIL recently has set up a new human vaccine facility in Hyderabad for manufacturing pediatric vaccines such as Hepatitisâ€“B, measles, MMR and DPT. The facility attempts to meet not only the domestic requirements but also the increased demand projected by UNICEF under the Global Alliance Vaccine Initiative (GAVI) program to meet the child immunization vaccine needs of poor countries. Further, IIL's R&D efforts are directed at new technologies in biologicals. IIL in collaboration with the Indian Institute of Science, Bangalore, is developing the world's first DNA Rabies vaccine under the Prime Minister's "Jai Vigyan Programme". It is not only a vaccine manufacturer, but also a vaccination service provider. While its Pratirodh Centers cater to the immunization needs of the farmers, Abhay Clinics offer vaccination services to humans. Its mission is to make immunity affordable to living beings. And in the process, it is creating a vibrant biotechnology base in the country and a leadership position in the international arena. IIL is keen on developing vaccines for various tropical diseases that are not of interest to the western countries but are extremely relevant for a country like India. Also its developmental work on human monoclonal antibodies for passive immunization against rabies is higly commended. All in all, it pursues a strategy of both in-house research and development and scientific collaboration with other research establishments to make an impact and grow. "Our Plan Is to Move into the Human Vaccines Market." "Innovation is the key in this business. And in India, we are innovative in imitating others. That's the talent we have got," admits KV Balasubramaniam, managing director, Indian Immunologicals. Running one of the top 10 animal health companies in the world, he strongly believes that there's a huge talent pool of researchers and genetic engineers who can do a lot better for the community. And once explored, India would surely become more prominent and there would be a huge demand in the field of biotechnology, he confirms. Good manufacturing practices have to be strictly adhered to during production and products should conform to the standards laid. Citing few other key points, he spoke to Sunitha Natti of CyberMedia News about IIL's expansion and future plans. Indian Immunologicals is the largest manufacturer of FMD vaccines. How did you manage to become one? IIL has emerged as the largest manufacturer of Foot and Mouth Disease (FMD) vaccine in the world on account of a strong domestic base (we have a market share of 80 percent of the large Indian FMDV market) and because of our emphasis on exports. This has been helped, in good measure, by our ability to give quality vaccines at a very affordable price, apart from constant upgradation of technology. IIL is also the largest supplier of the FMD vaccine to Food and Agriculture Organization (FAO). A leader in the animal health care products, how have things changed for IIL? When we started in 1983, National Dairy Development Board (NDDB) felt the need to serve the farmers ambit and launched the products at a very low cost. We were able to bring down the cost of the vaccines to as low as Rs 3.50. The company remained a one-product company till it set up its plant in Hyderabad in 1989-90. We realized that we needed to work on other vaccines. In 1994-95, we expanded on the vaccines portfolio. Apart from that, we also saw the need to tune to the changing markets as in this knowledge-based industry, we have to value people for the contribution that they make. Today, we are more performance-driven and innovative, besides being result-oriented. We believe in constant research and coming out with new products. What has been your experience in India and globally? Has the world begun to recognize IIL as a great vaccines manufacturer? What is next on your agenda? The world has slowly begun to recognize the Indian vaccine manufacturers as the ones who have the ability to fill the gap left by multinational companies who no longer find the mass market of pediatric vaccines profitable to operate. In IIL's case, it is certainly being recognized as a competent veterinary vaccine manufacturer. However, one must understand that the veterinary vaccine market is quite limited, unlike the human vaccine market, accounting for only $2 billion out of the $10 billion vaccine market. IIL has been recognized as a research-driven technologically competent manufacturer with the ability to respond to large requirements in a short duration. Our plan is to move into the human vaccines market. We would like to bring better value to the market with our proven ability of manufacturing technologically superior vaccines at affordable prices. We already operate the "Abhay Clinics" on franchisee basis and we will build on this successful business model. What is the standing of the Indian animal health care companies in the global scenario? As mentioned earlier, the human and veterinary vaccines market is around $10 billion. This comprises of $2 billion in animal health, growing at 4 percent per annum and $8 billion in human health growing at 9 percent per annum. The Indian market is very diminutive. The developed countries account for 85 percent of the total pharma industry and the Indian market is about $150 million, with the veterinary segment accounting for $20 million. There's no comparison in terms of market share but when assessed in volumes we have reasonable numbers. But prices in the developed countries are much higher and that's what makes the difference. In the vaccine industry, there are four companies that are dominating the global market. They operate in high-innovation driven, high-price markets. But we operate in a totally different paradigm. We are not innovators but imitators. However, we are now getting good on the innovation side too. We develop vaccines, which are already in the market and at affordable prices. Thus, although the volumes are high, because of low prices the value of the market gets limited. Can India become the vaccines hub of the world? Are there any bottlenecks? What are the issues and concerns and how should India position itself? India can become a major vaccine producer of the world provided it is able to effectively tap the growing human vaccines market, especially for the pediatric segment, such as Hepatitis B, Hib and influenza and focus on the now emerging Asian markets. In my view, the bottlenecks are only in terms of regulatory barriers in different markets and not so much in our scientific capabilities. Apart from this, it is also important that we learn to market our vaccines as technologically equivalent, if not better, to those produced by the western companies and establish ourselves as reliable suppliers of quality vaccines. Therefore, the issue is how the Indian industry positions itself on technology and how companies are able to gear up their marketing abilities in the international market. Can India become a preferred outsourcing destination for animal healthcare companies abroad? When we say outsourcing, it could mean manufacture or research. In both cases, it's the affirmative. Costs are comparatively low. It's about one-third lower in manufacturing and one-tenth lesser in research. We are transforming into a global player and the ethical aspects are being addressed and regulations are falling in place. So this is something that's good and one should make the most of it. What are your current capacities for vaccines and what are your key achievements? We presently have a capacity of 60 million quadrivalent doses of FMD vaccine, 30 million doses for other veterinary vaccines and 3 million doses of human rabies vaccine. We are creating manufacturing facilities for Hepatitis B, Hepatitis A, DPT, measles etc. with world-class capacities. Our most significant achievement has been in creating a highly talented and committed research group which has been able to develop several veterinary vaccines, most of them being the first in the country and the only few in the world. This has been backed by a strong marketing force, which has helped build large market shares for these products, mainly through a value proposition of affordable immunity, and backed by sound service support. We are also in the forefront of research and development of DNA and monoclonal antibodies for therapeutic uses. We are a niche player in vaccines, focused on this business and a successful organization, which balances the social commitment of NDDB and the demands of a profitable pharmaceutical player. What are your plans for the future? We are building new facilities for manufacturing products mainly for measles, DPT, Hepatitis etc. By March 2005, we would be launching Hepatitis-B vaccine commercially. This will be followed by the other vaccines. Any plans to look beyond the existing market base? Last year we could not do well, particularly in the area of exports, as we did not have a demand. But this year, we are very optimistic. Our thrust is in South-East Asia. The big markets for veterinary vaccines are Asia, South America and Africa. With good partnerships, there's a lot of scope for the export of veterinary vaccines in South America and Africa. How is the company geared up for the impending product-patent regimen and increased overseas competition? We have both advantages and disadvantages of the current patent regime. It has helped develop a competitive industry. However, if we have to compete globally, we have to respect international laws. The advantage in India is we have a very low-cost market. The vaccine prices in India are much more lower than any of the Western countries. In the next few years, you'll see a lot more Indian companies exporting vaccines. India would soon become a global hub for the vaccine development, as it can understand the technology very well. We are much better than the other developing countries including China. We are already on the roadmap to be the global hub. The reasons for this could be the huge domestic market, developed-pharma industry that can provide materials at a low cost, products which can be developed and produced at reasonable prices and a good pool of scientific talent. What's hindering the animal health care industry in India? Primarily the sector is small. About 85 percent of the population in India does not have access to good quality healthcare. Compounding this is the meager public expenditure being spent on this. You can well imagine the plight of the animals. In an effort to fill in this gap, we have launched a programme by developing vaccine centers under the operation "Pratirodh" programme. It provides vaccination services for farmers at affordable prices on a systematic basis. We would be expanding this programme in the next three to four years. For the current fiscal year what will be your R&D investments and turnover? Our annual turnover for the year 2003 stood at Rs 67 crore and we are targeting Rs 100 crore this year. And the investments in R&D would amount to five percent of the sales turnover figure.   ]]> <![CDATA[Gujarat's untapped bio-potential]]> https://biospectrumindia.com/news/95/2204/gujarats-untapped-bio-potential.html https://biospectrumindia.com/news/95/2204/gujarats-untapped-bio-potential.html Mon, 04 Oct 2004 18:38:00 +0530 Chief Minister Narendra Modi cutting the tape to inaugurate the exhibition. Dr Manju Sharma, former secretary, Department of Biotechnology called upon the government to nurture strong industryâ€“academia ties and strengthen the indigenous and region specific technologies. She also asked the big corporate houses to encourage Small and medium enterprises as this industry brings socio economic development faster to the society. For this the industry needs constant institutional support in the form of incubators and synergy between different departments/ regulatory agencies, she said. Other eminent people from the industry such as Purvi Mehta Bhatt, director, The Science Ashram, Dr Rashmi Barbhaiya, CEO, Dynametics Consulting LLC, Bhavin Mehta, head, business development, IPBP, Dr TM Manjunath, consultant, Monsanto Ltd, Prof Subhash Chand, IIT Delhi, Dr Villoo Morawala Patell, founder and CEO, Avestha Gengraine Technologies, Dipal Palkhiwala, director, marketing, Maps India, Bhalchandra Lele, general manager, engineering & projects, Sartorius India, Larry Paulson, agriculture officer, USAID, Sanjiv Bhasin, COO, Rabo India Finance, Dr PK Ghosh, Sr VP BioCare SBU Cadila Pharmaceuticals and Dr Milind Antani, legal & tax consultant, Nishith Desai Associates shared their views on topics ranging from venture funding, industrial enzymes to bio agriculture and bioinformatics at the conference. Besides having the longest coastline, strong cooperative base, active people participation, proactive government, business friendly industrial policy and existing biotechnology corporate base, the state is making all efforts to bring in awareness about biotechnology among students and also to bridge gap between industry and academia by organizing series of seminars. GSBTM has conducted one such seminar recently. "The government is also planning to make 'BioGujarat' a regular phenomenon to attract the investors to the state," informed J N Singh, secretary, Department of Science & Technology, Government of Gujarat. With these efforts and impending announcement of the biotechnology policy will definitely create a good foundation for the biotech industry and simultaneously push the socio economic growth of the state. "Biotechnology will protect our land from becoming desert" "There is great scope and opportunity in the biotechnology sector. We want to encourage this and are ready to take the risk in investing in R& D activities, " said the Chief Minister of Gujarat, Narendra Modi. Speaking after inaugurating 'BioGujarat â€“ 2004' a two day conference on biotechnology at Ahmedabad, the chief minister said, "I am hopeful about biotechnology, as this will protect our land from becoming desert." He added, "We are not ready to stop at biotechnology but are also looking at nanotechnology. From the next academic year the state syllabus will include chapters on nanotechnology and biotechnology. Through these efforts we want to create and build a strong foundation for the next generation." On the changing global scenario and patent laws, he said, "We should accept and adopt to the changing situation. Hence our state universities are considering starting integrated courses on patent laws in science and technology. To develop and ensure a strong partnership between industry and academia we are setting up a biotechnology park near MS University, Vadodara." "To encourage more scientists to take up projects on biotechnology and related topics the state government is working on insurance schemes. And we have invited insurance companies to work on this scheme, "said Modi. Besides playing a key role in opening venture capital fund for biotechnology, the chief minister said, the state has schemes/programs of subsidies for pilot projects. Releasing the compendium of biotechnology organizations in Gujarat prepared by Ernst & Young, Narendra Modi said, "The state will give all IT benefits to BT. We will treat both the industries equally and promote both IT and BT. We will provide all facilities to promote and develop the sector in the state."   ]]> <![CDATA[Drug Discovery to Manufacturing]]> https://biospectrumindia.com/news/95/1743/drug-discovery-to-manufacturing.html https://biospectrumindia.com/news/95/1743/drug-discovery-to-manufacturing.html Mon, 04 Oct 2004 18:36:00 +0530 Drug Discovery to Manufacturing IBC is organizing a conference on "Drug Discovery to Manufacturing: Global Partnering & New Science" in Renaissance Mumbai Hotel, Mumbai, on October 18-20 2004. The event will provide a forum for companies from the US, Europe and Asia-Pacific which are involved in drug discovery, clinical trials and manufacturing to come together to discuss scientific advances, business strategies and partnerships. The conference program features internationally renowned speakers and an exhibit hall showcasing the latest technologies, products and services that are driving this field. For further details, contact: custserv@ibcusa.com Biotech 2004 The second national conference of the Biotechnology Society of India, BioTech 2004, is being organized by the Institute of Genomics and Integrative Biology (IGIB), Delhi, from October 13-15, 2004 at India International Center in New Delhi. The theme of the event is "Challenges and Opportunities in Biotechnology". BioTech 2004 will focus on the recent advances in basic and applied research towards the development of globally competitive biotechnology. The three-day conference aims to provide a comprehensive academic program with contributions from national and international faculty and young researchers from academia and biotech industries. Guest lectures, oral and poster presentations on various topics including metagenomics, functional genomics, stem cells, SiRNAs, drug target identification, and bioinformatics are a part of the event. For further details, contact: rdas@igib.res.in BioTechnica Asia 2004 Deutsche Messe AG and Hannover Fairs Asia Pte Ltd are organizing BioTechnica Asia 2004, an international trade fair for biotechnology on October 12-14 2004 at Raffles City Convention Centre in Singapore. This will provide an opportunity to interact with the key decision-makers and buyers, venture capitalists and investors, R&D and medical and legal professionals of the biotech community. Exhibitors from bioengineering, equipment, bioinformatics/services, pharmaceuticals and medicine, nutrition/agri biotech, and environment are expected to participate in the event. This event will be held in conjunction with the BioMedical Asia 2004 conference. For further details, contact: biotechnica-asia@hfasin.com Mediphar Taipei 2004 Taiwan External Trade Development Council and Formosan Medical Association are conducting Mediphar Taipei 2004, an international show on medical equipment, pharmaceuticals and biotechnology on November 4-7 2004, in Taipei, Taiwan. The event has a biotech showcase featuring the latest R&D achievements in diagnostic devices, bulk drugs, biochips, etc. It will provide biotech companies an opportunity to explore the possibilities of this field and Taiwan's growing importance at the forefront of medicine. The event forges unlimited opportunity by bringing together medical professionals from across Taiwan and around the world with the best suppliers of medical material, equipment, technology, and services. For further details, contact: mediphar@taitra.org.tw In Vivo Molecular Imaging The Cambridge Healthtech Institute is organizing a conference on "In Vivo Molecular Imaging" from November 16-17, 2004 at Marriot Hotel, La Jolla in California. The theme of the event is bridging the gap from pre-clinical to clinical applications. The conference will examine the development of specific and efficient intracellular targeting and imaging systems that provide high resolution as well as high sensitivity. The speakers at the different sessions will highlight latest advances and issues related to technology innovations, pre-clinical imaging and clinical applications. For further details, contact: chi@healthtech.com ]]> <![CDATA[GMOs and the Politics (Perils) of Precautionary Principle]]> https://biospectrumindia.com/news/95/1148/gmos-and-the-politics-perils-of-precautionary-principle.html https://biospectrumindia.com/news/95/1148/gmos-and-the-politics-perils-of-precautionary-principle.html Mon, 04 Oct 2004 18:24:00 +0530 Luddites will never tell the public that world scientific and medical community has wholeheartedly endorsed the technology and GM crops as safe or that GM crops have undergone hundreds and thousands of tests the world over. The precautionary principle as applied to GMOs today in Europe under duress from the Greens is a classic case of the choicest abuse of a well-intentioned scientific approach to managing known risks. Asian anti-GMO groups are borrowing this same tactic to keep GM crops out of bounds in their countries much to the peril of their own agricultural development. Which sane person can argue against age old nuggets of wisdom like "be safe", "better be safe than sorry", "take caution", and "be careful". We all give these gems of advice to each other all the time whether one listens to them or not. The opponents of GM crops would have you believe that we really know next to nothing about the effects of GM crops on human health and the environment as they have not been tested sufficiently or properly by their purveyors. Unless all uncertainties are answered in the affirmative they say that GM crops should not be allowed into the market place. Luddites will never tell the public that world scientific and medical community has wholeheartedly endorsed the technology and GM crops as safe or that GM crops have undergone hundreds and thousands of tests the world over. Even in India, the Bt-cotton underwent almost seven years of testing before it was approved for commercialization. Ordinary (read gullible!) public would get certainly alarmed and will immediately agree to the proposition to ban or carry out more tests until one is sure that GMOs are absolutely and unequivocally safe. Little does the public know that this "scare mongering" by the anti-GMO lobby is just a diversionary tactic to block the development of biotechnology applications and a mere proxy for the Luddite mentality that has been largely imported from the European Greens into Asian countries by their local compatriots. It is really appalling how these kinds of scare tactics are delaying biotechnology transfer to developing countries of Asia and Africa to the peril of honest and good agriculture development. The 1992 Rio Declaration defines Precautionary Principle thus: where there are threats of serious or irreversible damage, lack of full scientific certainty shall not be used as a reason for postponing cost-effective measures to prevent environmental degradation. But, what is being pushed in the GMO arena is to use highly speculative risks of GMOs to ban them and stop new developments in the area of agricultural biotechnology. Despite having no meaningful scientific evidence of unmitigated or irreversible harm by GMOs and despite the safe use of GMOs since 1996, the activists groups led by the European Greens are demanding a complete ban as they are not convinced that they are or can be safe. Anti-GM activists are totally dishonest as they refuse to recognize that all human activities carry certain degree of inherent risks and that if we can identify them and manage them far more benefits can be derived by the society. By invoking the Precautionary Principle sensu stricto, its advocates are raising the regulatory standards bar all over the world making it prohibitively expensive to field test and commercialize GM crops. Most of the developing country governments are succumbing to this scare tactic and are indeed raising the regulatory review standards under pressure from the activist groups. This misguided biotechnology regulatory policy in the developing world is going to cost dearly in terms of missed opportunities. It is nobody's case not to have any proper regulatory oversight for introducing GMOs, but it is one that should be commensurate with scientifically assessed risks. The fact that the world has decided to have case-by-case review of GM crops before commercialization is an eminent instance of the application of "Precautionary Approach". One can realistically assess the risks by comparing to an unmodified counterpart of GMO in question and knowledge from centuries of experience growing such crops in different parts of the world. Literally thousands of risk assessment documents have been written for tens and thousands of field tests that have been conducted all over the world to clearly demonstrate that GM crops have no more or less adverse or significant impact on the environment than any other conventional crop. Major scientific academies of the world have come to the same conclusion and have put out long term monitoring advisory to identify any unidentified effects or impacts in the future. European Union spent almost 80 million euros on risk assessment research for more than a decade and a half to come to the same conclusion. There must be at least half a dozen medical associations in North America and Europe that have recommended that GM foods are safe. The Union of German Academies of Science and Humanities (Germany is strongly opposed to GMOs) was the latest to put out a similar scientific advisory that GM crops and foods are as safe as their conventional counterparts and in some instances superior and safer. 350 million Americans are serving as guinea pigs by consuming GM foods for almost a decade now without a single body bag being counted. Yet there is this constant refrain from the anti-GM lobby that all that these respected credible scientific bodies are saying is unbelievable and the regulatory authorities must demand more stringent tests for a long period fo time (I have even heard from some NGOs that they should test it for patently absurd period of 50 to 100 years) before allowing it to be commercialized. That is Precautionary Principle for them. They want ironclad guarantee that absolutely nothing happens to the environment and public health by the consumption of GMOs even after 100 years. Can any self-respecting scientist give such a guarantee? I think not. Then they say see science does not know everything which is true, but at least is engaged in its quest to unearth the truth based on experimentally verifiable facts. Their lobbying efforts are working in ever so many insidious ways to create new non-scientific barriers like ban on releasing GMOs into centers of origin and diversity and creating absurd and impractical "GM free" zones to protect biodiversity sanctuaries. GM free zones are absurd because GMOs have already got mixed up around the world and they do not recognize any sanctuaries and it is not necessary. GMOs are not an epidemic like plague or cholera. If it is impractical to have GM free zones, then they say, don't introduce GM crops at all. That is an indirect way of getting the technology banned. No one has drawn up an even a single plausible scenario of how a transfer of a transgene from GM crops to wild and weedy relatives would destroy biodiversity, yet! But, the relentless scare mongering continues. They cite the infamous Oxaca, Mexico case where certain Mexican maize land races having been "polluted" or "contaminated" by Bt-Maize. They refuse to acknowledge that Mexican peasants have for centuries preserved those fragile land races by crossing whatever races or lines of maize possible, a method known as "Creolilization", a wanton case of "genetic contamination" (another non-existent scientific term). By the way, the Mexican maize land races have not evaporated due to the out-crossing of the Bt gene. Now this same absurd theory is being invoked in Asia to prevent introduction of GM rice ostensibly to protect rice biodiversity. Surely, ancient and other traditional low yielding varieties of rice and other cultivated crops have disappeared from farmer's fields not because of extinction, but because of simple economics. But, those traditional varieties have all been collected and stored in germplasm collections all over the world both for posterity and for future use. Expert rice breeders and agronomists would tell you that any cross between cultivated rice and rice wild or weedy relatives will result in such unfit hybrids that they have no chance of survival. The common sense question to ask is: how is that in these fifty or more years of introducing high yielding rice and hybrid rice that the rice biodiversity (not to be confused with on-farm agro-biodiversity) has not destroyed or reduced rice biodiversity in the centers of origin and diversity? China has been growing GM soybean for a decade and its soybean diversity has not been affected. Here the point is not to protect biodiversity, but the point is to stop GM technology. No one will disagree that modern agriculture has caused enormous environmental impact (some good and some bad, perhaps more good!) because wherever man started to cultivate plants; he had to clear the land (destruction of the habitat!). But, we have come a long way since man started agriculture and there is no going back to being hunters and gatherers and certainly, organic farming is not going to feed the masses that will be equally environmentally disastrous (not to speak of its health impacts) if not more. A clear distinction must be made between "Precautionary Principle" and Precautionary Approach". The world has decided to regulate products of agricultural biotechnology and GM crops and is doing so. One can argue about how good or effective these regulations are in different parts of the world. But, to suggest that GM crops are dangerous and untested is being blatantly deceptive and unnecessarily creating scare. It is simply clear that anti-GM activist's sole purpose is to maintain their activism against GM crops for the sake of their own survival by involving a scientific sounding Precautionary Principle, which has nothing to do with either biosafety or environmental safety. It is self-interest, bad science and misuse of good science that are profoundly influencing regulatory policies around the world. "Frankenfood Myth: How Protest and Politics Threaten the Biotech Revolution" by Henry Miller and Greg Conko is a brilliant expose on the politicization (conspiracy!) of technology to kill it in its infancy. The fact of the matter is that the benefits of biotechnology are far greater than the risks that have been identified so far and it would be a crime to deny it to those who need it most. There is something known as excessive caution, which can undermine scientific and technological advancement and derail economies. Already trade restrictions are creeping in the GMO commodities based on restrictive Precautionary Principle and it will hurt both the producers and consumers. Governments must avoid seeking the utopian GMO free world; instead exercise common-sense (which is what science is after all!) approach to risk assessment and management based on best possible scientific evidence to usher in sustainable development and progress. We all want safety and we all want our environment to be safe more now than ever before. But, by propagating falsehoods and scare mongering, the anti-GM activists are perpetrating the worst possible crime on humanity by denying the most tested of all agricultural technology products. GM crops and foods are safer than adulterated, pesticide laced and vermin infested foods that are sold in many parts of Asia. We all want all foods to be safe, GM or no-GM. If one is fair, precautionary principle must be applied to the existing food supply and then we all know that all of us have to stop eating whatever we are eating. We should thank our stars that the present day anti-GM Luddites were not around when man started using fire. Otherwise, can you imagine being part of a fireless world and a cold civilization! The venerable Norman Borlaug recently wrote, "Although we must be prudent in assessing new technologies, these assessments must not be based on overly conservative or overtly inaccurate assumptions or be swayed by anti-business, anti-establishment, ant-globalization agendas of a few activists, or by the self interest of bureaucrats. They must be based on good science and good sense. It is easy to forget that science offers more than a body of knowledge and a process for adding a new knowledge. It tells us not only the limits of what we know but also what we don't know. It identifies areas of uncertainty and offers an estimate of how great and critical that uncertainty is likely to be." Everyone must recognize that the modern day environmental movement for raising global awareness about the state of the air and water quality and destruction of the habitat as the most profound cause of loss of biodiversity. The need of the hour is to adopt technologies that can solve those environmental problems and not give into ant-GM propaganda and save humanity and the environment. The real unfortunate part of this anti-GM movement is that it is being imported into Asia and Africa blindly and sometimes not so blindly by the compatriots of the European greens just for the sake of maintaining their activism without checking the realties of their own situation. Dr. Shanthu Shantharam is the President of a biotechnology affairs consulting firm, Biologistics International in Maryland, USA.     ]]> <![CDATA[Enforcement of IPRs Remains an Enigma]]> https://biospectrumindia.com/news/95/2720/enforcement-of-iprs-remains-an-enigma.html https://biospectrumindia.com/news/95/2720/enforcement-of-iprs-remains-an-enigma.html Mon, 04 Oct 2004 18:21:00 +0530 LEGAL VIEW For meeting the challenges arising out of the new intellectual property regime and to derive maximum benefits from the intellectual wealth of the nation, the innovative and creative activities have to be stimulated, encouraged, protected and exploited. Most successful brands across the world are victims of IPR abuses. The most common violation being counterfeiting. Counterfeiting circumvents the delivery of legitimate products in legitimate packaging through legitimate distribution channels without authority or right and with a view to deceive, by passing the copy or thing forged for that which is original or genuine. While counterfeiting is generally associated with the infringement of trademarks, it actually involves all aspects of IPR's (i.e. patents, copyrights, geographical indicators, design, trade secret etc., or a combination of them). The effect of counterfeiting can be extremely debilitating for the IPR holder, as the fake goods are usually of lower quality and price. Thus, in so far as such goods confuse or mislead consumers, they tend to eat into the originator's (IPR holder) market and the value of the originator's intellectual capital. Why does it take place? Some of the reasons why piracy and counterfeiting are conducted on a commercial scale are discussed below: Profitability in pirated and counterfeit products can be easily achieved. These goods are sold for much less than the cost of the genuine product but still at a considerable return, either by pitching the price just below genuine product or alternatively by pitching it very low and selling a much larger quantity. The lack of effective intellectual property law in many jurisdictions coupled with the lack of resource and/or the high cost in enforcing such intellectual property laws is also a prime factor encouraging people to resort to such means. A public perception is that piracy and counterfeiting are low-grade harmless crimes. Theft of intellectual property is not yet considered to be equivalent to other property crimes, such as theft of personal property or trespass to land or fraud. There is an attitude amongst some people that piracy and counterfeiting are merely "commercial offences" unlike other property offences, which are regarded as crimes. Implications of counterfeiting Industry The counterfeiters deprive legitimate industry of revenue, goodwill and consumer loyalty build over time and with considerable effort. Industry loses substantial revenue which reduces investment efforts in bringing better products to market. Products for human consumption/applications carry a high risk of being held legally accountable. In addition, there is the possibility of product liability, at least until the manufacturer is able to prove that the defective product is not their responsibility because it is a counterfeit. Government The government loses revenue since the counterfeiters do not pay any duties or taxes. The resultant reduction in the net tax is highly significant. In the long run manufacturers of spurious products harm the economy and the government's attempts towards development. MNC companies Foreign companies in the drugs sector will analyze the IPR regime before investing in India, as they would be concerned if their investment in India can be negated by competing counterfeit activity followed by loss of goodwill and revenue. Society The consumer is not only cheated into buying a product (often at same price) but at times it can be dangerous particularly, in cases, of spurious drugs/pharmaceuticals and food products. Enforcement challenges of IPR in India In India, counterfeiting has been a major problem. Studies undertaken on counterfeiting in the pharmaceutical sector shows that 15-40 percent medicines are counterfeits. In this scenario, the industry and the enforcement agencies need to step up their efforts and become more innovative to combat counterfeiting. It is now critical for the Indian industry to understand the implications of counterfeiting-both legal and economic, to protect its own business interests in India and abroad. There is a need to develop advanced authentication technologies for counterfeit detection. On the enforcement side, various departments such as the customs and police department need to be aware of the latest techniques being employed in other countries to detect and counter counterfeiting. The enforcement of IPR is the ability of the right holder to protect his assets. An efficient system that provides effective protection through enforcement mechanizations is necessary to make the IP rights meaningful. The legal framework for tackling counterfeiting is in place in India. India has a number of laws dealing with counterfeiting which are, inter alia, such as The Trademarks Act, 1999 Copyright Act, 1957, Indian Patents Act, 1970 Designs Act, The Drugs and Cosmetics Act, 1940, The Prevention of Food Adulteration Act, 1954, Consumer Protection Act, 1986 and recourse can also be taken to the Indian Penal Code. All have penal provisions and have made counterfeit a cognizable offence, however the same does not provide for a strong deterrent to the counterfeiters. One of the major drawbacks even if ex parte seizure orders are granted by the Indian courts and goods are subsequently seized is that the counterfeiters are adept at the "shell game", moving across to another area or to another trade to resume operations. Such a method of enforcement would fail to serve as a convincing deterrence to the profit-maximizing entrepreneur who engages in such a piracy. Secondly, the officers are poorly trained and underpaid and smuggling is common. There is protection provided by local officials and lack of strong legislative tools. Inadequate civil damages and low criminal penalties are one of the primary factors for counterfeiters to flourish and hence as a result, the laws do not provide for adequate punishments. Lastly, there is a complete lack of coordination among various agencies. Strategies for action The key element necessary for a successful approach to enforcement is to have a good dialogue and cooperation between right holders (industry) and enforcement authorities. In addition, the strategy must remain flexible and it must be continuously reviewed. It is vital to have/collect as much information as possible about the problem. This is dependant on an effective investigation. Some of the key issues for consideration are: How widespread is the problem (in that market/country/elsewhere)? Where is the manufacturing taking place? Is the product for export/import, or produced only for the local market? How easy/difficult is it to manufacture the goods? What is objectionable â€“labeling? Embroidered marks? Where/how are the objectionable aspects applied to the goods? How do you differentiate the genuine from the counterfeit? What is the value of the genuine product? How much of a genuine market is under threat (a vital criterion in order to assess the proportionality of any enforcement effort in terms of cost and management time)? While the right holders may be able to seek injunctive relief and pursue civil action against violators such as street vendors and retail outlets, it is much more difficult for right holders to infiltrate the operations of a large commercial scale infringement operations to bring about raids and criminal prosecutions. It will require the involvement of police and other enforcement authorities having legal powers to conduct undercover investigative operations and further raids. It is in this context, that the industries would need high quality professional services to enforce their IP rights (by bringing about raids, criminal prosecutions, etc). This perhaps will be the most effective way to tackle the problem of counterfeiting. It is vital that the government, industry and enforcement bodies work together to ensure consumers and business are properly protected and not exploited by organized crime. Counterfeiting and piracy is growing and the measures outlined here will go a long way in combating this criminal activity. By sharing information and intelligence it will become more difficult for counterfeiters and pirates to operate. This will spell in better protection of consumers; disruption of organized crime and the industry will stop losing staggering amount of revenue every year. The Government of India should seriously consider coming out with a National Intellectual Policy or a Task Force committee to address the important issues of IPR, especially to study the growing menace of infringement of IPR rights of right holders. This would help instill confidence in the foreign investors and the Indian industry. By Kirit S. Javali, Partner advocates@jafajavali.com Law Offices of Jafa & Javali is a full-fledged corporate law firm with niche expertise in IPR & Biotech law, with offices in New Delhi, Bangalore and Mumbai.         ]]> <![CDATA[Melaka to invest $3mn annually to develop biotechnology]]> https://biospectrumindia.com/news/95/3732/melaka-to-invest-3mn-annually-to-develop-biotechnology.html https://biospectrumindia.com/news/95/3732/melaka-to-invest-3mn-annually-to-develop-biotechnology.html Mon, 04 Oct 2004 18:14:00 +0530 Asia-Pacific Melaka to invest $3mn annually to develop biotechnology The Melaka state government in Malaysia has announced that it will provide about $3 million annually to develop biotechnology-based products in the state. The Chief Minister of Melaka Datuk Mohd Ali Rustam said, "Of this, $2.2 million is for administration while another $0.6 million is for product manufacturing." "We (the state government) see this (allocation) as beneficial (to us) and we expect the number will increase next year depending on the returns we derive from it," he informed at the signing of a MoU between Melaka Biotech Holdings Sdn Bhd (Melaka Biotech) and Universiti Kuala Lumpur (UniKL). This MoU will foster co-operation among the two parties in skills development, research and development facilities in biotechnology and using Melaka Biotech's expertise in UniKL's academic system. As for the Institut Bioteknologi Melaka at Bandar MITC in Ayer Keroh, Mohd Ali said the Melaka state government had so far invested more than RM11 million at the institute and had also appointed biotechnology experts and implemented three joint-venture biotechnology-based projects. The three projects are in seaweed farming in Jasin, the development of bio-informatic applications and manufacture of oil essences costing $0.8 million. The managing director of Melaka Biotech, Prof. Dr Faridah Habib Shah, said her company had not estimated the returns from the projects because they were relatively new. "We have been in the industry for just one-and-a-half year. We need to build up our facilities and relationship with investors first before we can think of the potential returns as we are still in the process of building up the facilities and investor relationship," she explained. Melaka Biotech has so far identified 10 potential products to be commercialized, including herbs like misai kuching, halia bara and kacip fatimah. The Melaka state government has provided 25-acre area for seaweed farming at Jasin and another 10 acres for herbs cultivation at the Selandar Agricultural Park. Source: www.bic.org.my NZBio disappointed at government decision to ratify Cartagena protocol New Zealand Biotech Industry Organization (NZBio) has expressed its disappointment on the government's decision to ratify the Cartagena Protocol on Biosafety. The Protocol seeks to regulate international trade of Living Modified Organisms (LMOs). "NZBio believes the government has been premature in deciding to ratify because of the uncertainties the Protocol presents and that the decision will have a negative impact on the economy, "said Brian Ward, CEO of the biotechnology industry organizations. He noted that ratifying the Cartagena Protocol would place a significant burden on New Zealand's exporters, who will now face the additional costs of complying with documentation requirements relating to the export of LMOs. It also creates a disincentive to develop innovative technologies in New Zealand and will impact on the development of novel solutions for the agricultural, medical and research sectors. He further observed that the decision to ratify is an unnecessary hurdle for an emerging industry that is a key platform for the future growth of the economy. Source: www.nzbio.org.nz South Korean health institute to open office at Glasgow The Korea Health Industry Development Institute (KHIDI) has announced the establishment of an office at the West of Scotland Science Park in Glasgow. It will help manage a multi-million investment in Scottish drug development research projects. KHIDI, on behalf of the South Korean government and its industry partners, is looking to invest up to $25 million in Scottish projects over the next nine years. This is invested through the International Collaborative Research Program for Drug Development. Scotland is the first in line to take full advantage of working with South Korean life sciences companies through this initiative, with a number of Scottish organizations having recently submitted research proposals for 2004-2005. The successful Scottish research project bids will be announced in November. This initiative builds on the work of the Korean-Scotland BioAlliance, which has held two symposiums in Seoul and has seen numerous business developments visits to Scotland by Korean pharmaceutical and life sciences companies. The latest BioSymposium took place earlier this year with five Scottish companies (Encap, ExpressOn, Hannah Interactions, Haptogen and Quintiles) and four universities (Aberdeen, Edinburgh, Glasgow and Strathclyde) attending. Representatives from Korean companies such as LG, CJ, Hwail, Daewoong, Crystal Genomics and Hyundai Pharmaceutical visited Scotland in July to meet Scottish companies and universities, many of which are expected to revisit South Korea in October. Source: www.scottish-enterprise.com Europe BIA hails government moves to investigate fundraising in the UK The BioIndustry Association (BIA) hailed the government's confirmation that it is to investigate the fundraising difficulties experienced by the UK's bioscience sector in comparison to regimes elsewhere. The BIA also welcomed the involvement of Paul Myners (Chairman of M&S) who brings valuable fresh thinking to an undeniably complicated and sensitive issue. In 2002, European bioscience companies raised Euro1.98 billion, about half the 2001 total. By comparison their US peers raised almost 3.4 times as much as their European peers. At the same time valuations of bioscience companies listed on public markets also declined across the globe. Commenting on the issue Aisling Burnand, chief executive, BIA said, "One of the recommendations included in Bioscience 2015, the most significant report into the UK's bioscience sector was a relaxation of the pre-emption guidelines. The involvement of a fresh pair of eyes in the form of Paul Myners is therefore excellent news. He is someone who understands the perspective of both companies and investors." "UK biotechnology companies are unfairly hampered when one looks to, for example, the US. Companies in the US enjoy greater flexibility in raising new equity capital and listed companies may issue new shares for cash in amounts of up to at least 20 percent of their share capital at a discount to the market price without needing to obtain shareholder consent. Bioscience is a global business and therefore we believe that it is important that there is a level playing field financially for bioscience companies," he added. There are particular circumstances applying to the fundraising difficulties being faced by the UK's bioscience sector. Financial demands on bioscience are enormous with very heavy capital requirements before companies can become very profitable. The top 10 US bioscience companies with market capitalization of up to $70 billion needed to raise $700 million from investors before ever reaching profitability. Aisling Burnand noted, "We do appreciate the sensitivities involved in reviewing pre-emption rights and wish to work in partnership with the government and other interested parties to see if progress can be made. The government has greatly invested in the UK science. That public policy investment needs a level playing field in financial terms, otherwise the support will not bear fruit. Bioscience is a sector that requires long development periods that, in turn, require regular injections of cash. If these injections are not made, the economic and healthcare benefits offered by the bioscience sector will not be delivered. When it comes to pre-emption rights, one size does not fit all." Source: ww.bioindustry.org GTI projects strengthen ties with bioscience A £4.5 million project to boost Scotland's growing reputation as a pioneer in life science research and development has been launched by The Scottish Centre for Genomic Technology and Informatics (GTI). This funding follows Scottish Enterprise Edinburgh and Lothian's announcement of a land purchase to allow site preparation for a $280 million Centre for Biomedical Research at Little France. The funding will help GTI provide, support and backing for commercial businesses developing products and services for use within the bio-medical science community, promote knowledge transfer to industry and the wider professional community, increase interaction between academia and commerce assist development of concepts for new company creation. The funding includes of contributions from SE Edinburgh and Lothian, European ERDF aid, the University of Edinburgh and commercial sources. It will encourage commercial research to mix with academic expertise and clinical practice. Source: www.scottish-enterprise.com EC allows sale of GM maize in member states The European Commission withdrew from its agenda the proposal to establish labelling thresholds for trace amounts of EU approved GM seed in conventional seed. At the same time, the Commission moved forward in approving the addition of 17 GM maize varieties to the EU Common Seed Catalogue, allowing the sale of these varieties in all 25 EU member states. "It is regrettable that, once again, the Commission has chosen to ignore its responsibility to establish a common European legal basis for the setting of thresholds for trace levels of GM seed in conventional seed. EuropaBio and other stakeholders are disappointed, having worked with the Commission for over five years to establish practical and workable thresholds," said Simon Barber, director of PBU, EuropaBio. "It is economically unsustainable and will unnecessarily harm the competitiveness of the European industry and its customers, the European farmers community". "However, we do welcome the Commission's addition of 17 approved GM maize varieties to the European Common Seed Catalogue, allowing more of Europe's farmers to see for themselves the farm level and environmental benefits of this technology. Absolute purity is just not possible in the production of seeds, and time and again, the seed industry and farmers in Europe face extraordinary legal uncertainty because the Commission has not been able to agree on practical and workable thresholds. To allow for the present situation of unrealistic, unclear and legally disputable national legislation to remain is irresponsible," added Simon Barber. "It's ironic that farmers may legally grow fields of GM crops, yet thresholds for trace levels of these in seed have not been established. Hence EuropaBio has urged the Commission to fill this gap in the European GM regulatory package by establishing clear, practical and workable thresholds, as a matter of priority." Source: www.europabio.org Fresh thrust to agribiotech in Europe For the first time since its establishment, the Agricultural Biotechnology International Conference (ABIC 2004) was held outside Canada. This premier conference on agricultural biotechnology was held in Cologne, Germany under the slogan "AgBiotech goes Europe" from September 12-15, 2004. This conference was aimed to bring AgBiotech back to Europe. As it came in a year when the European Union has lifted its five-year moratorium on new GM foods and for the first time, approved a GM seed variety for planting throughout the EU territory. With the implementation of new European regulations and a more competitive European market, the conference gave new impulses to the European AgBiotech research and AgBiotech business in Europe. The conference was attended by more than 700 delegates, which covered a wide range of topics like the role and importance of ethics for agri biotechnology in Europe; Controlling expression in transgenics; Plant as green factories; Co-existance of transgenic and non transgenic crops; Synergies between breeding and biotechnlogy; Biotechnology and food security for the resource poor; Improvement in non food crops; Nutraceuticals as links between food and health: using biotechnology to improve our food; etc. The Agricultural Biotechnology International Conference was set up in Canada in 1996 by the ABIC Foundation, where scientists, industrial managers, investors and policy makers come together for an intensive exchange of experience in order to give new momentum to further the development of agricultural biotechnology. This unique global forum has been created for the discussion of results from research and development in order to enable co-operation between academic research institutes and partners from industry so that the transfer of laboratory results to industrial scale may be accelerated. America BIO applauds New Jersey Governor's backing on stem cell research Biotechnology Industry Organization (BIO) has admired the advocacy of New Jersey Governor McGreevey on stem cell research. The powerful properties of embryonic stem cells consistently demonstrated in peer-reviewed studies have generated excitement in the scientific community. Researchers have long believed that stem cell research could help develop treatments and cures for debilitating conditions such as cancer, spinal cord injury, and diabetes. "The private sector has made enormous progress in this field since the isolation of the human embryonic stem cell in 1998. But federal funding, through the NIH, will accelerate the pace of discovery and lead to cures and treatments for patients sooner. "Current federal restrictions are stifling stem cell research in the US. BIO urges removal of the restrictions, along with the creation of guidelines to provide an ethical framework for the research," noted Michael Werner, chief of policy, BIO. Source: http://www.bio.org BCO announces inaugural public policy forum The Biotechnology Council of Ontario (BCO) will host a major provincial Public Policy Forum in Toronto during October. The Forum will bring together organizations and individuals from across the biotechnology sector to define strategic policies for this critical economic area of the province. The BCO's Public Policy Forum will be a full-day open discussion on the needs, challenges, and advantages of the biotechnology sector in Ontario. The Forum will give the Ontario biotechnology industry a rational, transparent, and inclusive policy development process and provide the BCO with its annul "terms of reference" to bring to government. Throughout the day, there will be a series of breakout sessions, as well as featured speakers with specific expertise in public policy formation, development, and implementation. Leading up to the Forum, the BCO has put in place an open policy development process to seek input on policy initiatives to nurture and strengthen four key drivers of the biotechnology industry-talent and human resources; the regulatory and legal environment; alliances/partnerships; and access to capital. These drivers were first identified in Getting OnTRAC-Benchmarking Ontario's Biotechnology Sector, a policy paper drafted for the BCO's November 2003 Roundtable. "The BCO has been able to bring together the diverse groups representing the Ontario biotech community to collaborate on key policy issues," said Dale Patterson, executive vice president, Canadian Medical Discoveries Fund and chair of the BCO Founding Steering Committee. Source: www.biotech.ca New York state uses bioscience to fuel economy State funding for the biosciences has grown dramatically in the past three years in New York, according to a new study by the Battelle Memorial Institute, the State Science and Technology Institute (SSTI) and Fleishman-Hillard International Communications for the Biotechnology Industry Organization (BIO). According to the study, "Laboratories of Innovation: State Bioscience Initiatives 2004", New York ranks second in the US in three areas: total university R&D expenditures ($2.76 billion), life sciences R&D expenditures ($1.89 billion), and biological scientists in the workforce (more than 33,000). The study also reported that New York is third in the country in total National Institutes of Health support to institutions ($1.71 billion) as well as higher education degrees in biological sciences (nearly 6,400). "We're proud that New York is fast becoming a world leader in biotechnology research and that we've taken unprecedented steps to attract new jobs and biotech companies to New York," said New York Governor George E Pataki. "New York has a wealth of examples of how our successful biotechnology strategy has built upon the unique strengths and assets of our State economy all across New York. Our biotechnology companies are expanding and creating new, good paying high-tech jobs. As we move ahead with Phase II of New York's high-technology and biotechnology job creation efforts, New York is fostering the growth and expansion of new and existing biotechnology companies, which is playing an important role in our ambitious effort to create one million new jobs in New York by the end of the decade." The BIO-Batelle study is the most comprehensive analysis ever done to quantify the scope and impact of bioscience employment in all 50 states. It also examines programs in each state to promote the development of bioscience companies. The study finds that employment and other economic activity in the biosciences has grown dramatically in the past three years, and states working to attract bioscience companies are learning that success means specializing in specific sub-sectors. "With 749 establishments in four industry subsectors employing more than 36,700 people, the bioscience industry in New York continues to be of growing importance to the state," said Karin Duncker, executive director, New York State Biotechnology Association (NYBA). Source: www.nyba.org Vatican listens to biotech food merits The US Embassy to the Holy See, in cooperation with the Pontifical Academy of Sciences, hosted a seminar at the Gregorian University in Rome on September 23, 2004. The theme of the seminar was "Feeding a Hungry World: The Moral Imperative of Biotechnology". The conference brought together prominent scientists, leading experts in humanitarian relief and agricultural development in the developing world and farmers working with biotech foods to explore the potential of genetically modified organisms to address hunger and malnutrition. Its various sessions examined the current state of the global food crisis, the theological and moral case for biotech food, scientific advances in biotech crops, how developing world farmers have used biotech crops and debunking the myths of biotechnology. Among the speakers were Rev. Gonzalo Miranda, LC, Dean of the School of Bioethics, Pontifical Athenaeum Regina Apostolorum, Rome; Piero Morandini, Professor of genetic biotechnology, University of Milan; Prabhu Pingali, director of the Agricultural and Development Economics Division of FAO, UN, Rome; CS Prakash, professor, Tuskegee University, Alabama, USA; Carl Pray, professor, Rutgers University, New Jersey, USA, director of the Department of Agricultural Food and Resource Economics, graduate program; Peter Raven, member of the Pontifical Academy of Sciences, director of the Missouri Botanical Garden and Engelmann, professor of botany at Washington University in St. Louis, USA. Expectedly the conference has been criticized by many anti GM organizations and has raised eyebrows amongst many in the catholic community. South Africa launches new biotech policyAfrica South Africa launches new biotech policy On September 17, 2004 South African Science and Technology Minister Mosibudi Mangena announced the launch of a new South African biotechnology policy describing biotechnology development needs and opportunities in areas such as human health, plant improvement, animal health, and industrial processes. Mangena said that the launch of the policy "serves as a rallying call to industry to join us in developing a bio-economy" in South Africa. He said that the government recognizes the potential benefits of biotechnology, and, "Government is committed to creating the best possible climate, be it regulatory, political or commercial, for biotechnology investment." The South African government has invested $67.6 million in infrastructure to support biotechnology development, including setting up Biotechnology Regional Investment Centres (BRICs) to support and incubate research in the field. The three BRICs are the Western Cape Biotech Institute, the Lifelab in Durban, and Biopad, which covers research initiatives in the central and northern areas of the country. Included in the total budget of $45 million is $10million that has been earmarked for funding the National Bio-Informatics Network, a Cray supercomputer based at the University of the Western Cape. In a related report, Mangena also told a Johannesburg meeting on his department's strategic review and forecast on biotechnology platforms, that since implementing the country's National Biotechnology Strategy, the department has created five Trusts as agencies aimed with fasttracking the local biotech sector. "We need to recognize that, while the government is committed to developing biotech for South Africa, it can only be done through meaningful partnership with our biotech stakeholders, and with industry. We are determined to give the local sector every opportunity to mature responsibly as an African leader in biotechnology," the Secretary said. Source: www.allafrica.com and www.africabio.com Biotechnology gaining momentum in Africa The acceptance of biotechnology is gaining momentum in Africa as more and more countries realize the potential it offers for sustainable food production as another tool to help eradicate famine and poverty, says Prof. Jocelyn Webster, executive director of AfricaBio. Speaking in Pretoria at a Southern Africa Biotechnology Communications Training Workshop, she said it is hoped that by the end of 2005 most countries in Africa would have draft biosafety frameworks in place. The workshop was organized by AfricaBio to train delegates regarding the need for biotech communication to inform the public in Southern African countries about biotechnology. More than 70 delegates from 10 of the 14 Southern African Development Community countries (SADC) attended. Representatives from Kenya, Cote divioire, Tanzania and the US also attended. She pointed out that 30 African countries, including six SADC members, had already signed the Cartagena Biosafety Protocol (CBP). "AfricaBio will continue to assist African governments, tertiary institutions, the biotech industry and public research institutions involved in Living Modified Organisms (LMOs), to deal with the implications of the Cartagena Biosafety Protocol, "Prof Dr Webster said. "We will help train more people to become available to public sector institutions for this purpose." Several delegates indicated that they are requesting their governments to put the necessary legal frameworks in place. They also asked the South African authorities to assist with these procedures. A consumer survey conducted under the auspices of the University of Pretoria in January 2004 indicated that 58 percent of consumers in Gauteng and 56 percent in Cape Town considered GM food to be as safe as conventional foods. The survey also found that respondents had confidence in government regulatory control measures. Source: www.africabio.com Biotech is catching up as cutting edge technology: Dr Paul Zambezi "Information technology is a leading cutting edge technology, but biotechnology is catching up," says Dr Paul Zambezi, permanent secretary for the Zambian ministry of science, technology and vocational training. Biotechnology has applications in agriculture, health and industry, and can reduce use of pesticides while improving yields. Zambia adopted a policy on biotechnology and biosafety in 2003 and is now developing a strategy for implementation. Public awareness is one of the key components. However, Zambezi cautions "Scientists must speak with one voice. We also do not want wild statements like we don't want biotechnology or we don't want genes in our tomatoes. Scientists need to understand that their concerns are different from consumer concerns." Zambezi opened the biotechnology communication workshop organized by the Biotechnology Outreach Society of Zambia (BOSZ) that was attended by over 50 representatives from the media, government departments, members of parliament, and scientists. AfricaBio was represented by one of its board members, Dr Wynand van der Walt, who had a private discussion with Zambezi and offered to facilitate a meeting between the minister and his South Africa counterparts. Modern biotechnology in Zambia is still in an embryonic stage, according to Zambezi. Apprehension exists about safety of GM food, environmental effects, adequate regulations and ethics of patenting. Countries need to assess benefits and risks of new technologies. Zambezi urged the media to work with scientists as stakeholders with the focus on national interests. Concerns must be addressed with factual information. Member of parliament Emmerson Mudenda explained, "Zambia did not have biosafety systems in place when food aid was donated by the US in 2002. These consignments contained grain from GM crops and most information on safety was disseminated by anti-GM groups from Europe. Zambian scientists presented conflicting views to government. Government has a duty to ensure that food made available to consumers was safe." "Zambia is in the process of creating an enabling environment for safe and responsible biotechnology application. Communication is needed for improved public understanding and a critical mass of Zambians will have to be developed to act as communicators," urged Dr Luke Mumba, chairperson of BOSZ. Source: www.africabio.com Biotech lab launched at Unam A gene-modified organism testing, training and research lab was recently launched at the University of Namibia. This assumes significance, as till date there was no institution dealing with the application of modern biotechnology techniques there. The idea of setting up a biochemistry and biotechnology lab for research was spawned way back in 1998 but has finally taken shape now. The laboratory will have a crucial role to play in assisting government and interested institutions in reinforcing and implementing the National Biosafety Framework by testing and monitoring the movement of grain, seeds and other items that might be genetically modified. The lab would carry out capacity building through training and research. The Convention of Biological Diversity (UNEP-GEF) has funded the lab equipment.       ]]> <![CDATA[PIL Petitioner: NGO traced to Wockhardt Manager]]> https://biospectrumindia.com/news/95/2465/pil-petitioner-ngo-traced-to-wockhardt-manager.html https://biospectrumindia.com/news/95/2465/pil-petitioner-ngo-traced-to-wockhardt-manager.html Fri, 01 Oct 2004 17:30:00 +0530 The mystery over the identity of Aadar Destitute and Old People's Home (ADOPH), the letter head Non-Governmental Organization (NGO) which had filed a public interest litigation against clinical trials of insulin by Biocon and streptokinase trials by Shantha Biotechnics is over. The petitioner's address is the home of Mumbai-based Wockhardt's vice president (business development) Col. (retd) LJS Gill. Col. Gill lives in 1101, B Block, Brooke Hill Towers, IIIrd Cross Lane, Lokhandwala Complex, Andheri (West)Mumbai. He is also president, Wockhart HMI AIDS Relief Foundation (WHARF). The petitioner, Mrs Preet Maju, 48, who claimed to be the trustee of ADOPH in the petition, does not live at this address. It is the house of Col. Gill. BioSpectrum has verified this by talking to the inmates of the address mentioned above and also from the MTNL telephone directory. A team of Indian Express journalists has reported that Mrs Preet Maju lives with her husband in Bhilai. Mrs Maju is believed to be a sister-in-law of Col. Gill. Over a dozen telephone calls to Col. Gill to get his version on the episode remained unanswered. Wockhardt officials have confirmed that Col. Gill is their employee. Col. Gill has avoided all contacts with the BioSpectrum team, both at home and office. Col. Gill Col. Gill, aged 53, has a masters degree in Defence Studies and joined Wockhardt on August 16, 2000. Prior to joining Wockhardt he was the CEO of Atco Healthcare Products. A detailed questionnaire was sent by BioSpectrum to Wockhardt chairman Habil Khorakiwala. He chose to respond through Wockhardt's deputy general manager (DGM) Shyam Kumar thus: "Please refer to your mail addressed to Mr Khorakiwala. We are surprised at the various assumptions that you have made. Our company has nothing to do with the NGO. The various points that you have raised amount to an insinuation against Wockhardt and its employees. You must be aware that Wockhardt is a leader in recombinant biotechnology and have three products in the market. It is wrong on your part to make such wild allegations against an organization, which has established its credibility over the last 40 years. If, however, we find that our name is sullied any way, we will be forced to take legal recourse against your publication." The questions were specific and Wockhardt's reply has skirted all these questions. 1. A Public Interest Litigation against clinical trials of insulin by Biocon was filed in the Supreme Court in February 2003 which came up for hearing on August 20. The petitioner was a Mumbai-based NGO, Aadar Destitute and Old People Home (ADOPH). Investigations by journalists from BioSpectrum and Indian Express have discovered that this NGO is a "fictitious" organization. And in the address mentioned in the PIL, a senior employee of Wockhardt Ltd, Col. (retd) LJS Gill lives. What is the connection between your employee and the "NGO"? 2. Wockhardt is a serious player in the insulin market, having launched your own biotech version in 2003. A PIL, which will delay the entry of a competing product, is bound to benefit Wockhardt. Why has a Senior Wockhardt manager resorted to such an unfair business tactic? 3. As a company, which prides on its corporate governance policies, does your organization support such a petition, which is bound to bring bad name to the entire biotech and pharma industry? 4. What remedial actions do you propose to take to enhance the reputation of your organization and also clarify the circumstances leading to the filing such a PIL? 5. The PIL has also complained against another Indian biotech company, Shantha Biotechnics, again based on information sent to the regulatory agency by a Bangalore-based NGO, Anikethan. This NGO too has based it complaints on information from Shantha's competitors and the complaint has been dismissed by the regulator. Why does one of your senior managers lend his name to tarnishing rival companies in the market place? Meanwhile, the petition was taken up for hearing by the bench comprising Justice N Santosh Hegde, Justice SB Sinha and Justice AK Mathur on September 24. The judges denied the petitioner's request to order an injunction against the clinical trials being carried out by Biocon. According to a report in the Bangalore-based newspaper, Deccan Herald, the justices asked the petitioner's counsel, Mukul Rohatgi who was funding the NGO and for what purpose. Deccan Herald has also reported that the Supreme Court judges have accepted the explanations given by the Ministry of Environment and Forests in its affidavit that on July 14, the ministry has condoned the procedural lapses in the human clinical trials of insulin by Biocon. The affidavit said the procedural lapse was due to some confusing guidelines. N Suresh and Narayan Kulkarni "We are shocked to learn that a senior executive of a company of the stature of Wockhardt is linked to the dubious NGO who attempted to undermine our interests in such a malafide manner.", said Kiran Mazumdar-Shaw, Chairman and Managing Director, Biocon Stupid Act "This is a stupid act. To get the major pie in the short term, companies will indulge in such acts. In the long run, it won't survive. Big biopharmaceutical companies are taking safety measures while going for clinical trials of their rDNA products. This will have no effect on the growth of the bio services sector in India, which is just picking up in the last few years. Better regulatory controls/measures may bring down such acts in future." Ashish K Dasgupta, director, Lambda Therapeutic, Mumbai Undue Interference "Though I do not fully know the details about this, in general I can say that all the pharmaceutical companies are following the guidelines of the Drug Controller General of India (DCGI). There are ethical committees, guidelines to maintain good clinical practices while conducting clinical trials and research. Organizations/agencies like Genetic Engineering Approval Committee (GEAC), DCGI are there to approve new drugs. However extra efforts should be made to keep checks and balances without affecting the rights of the human being. Companies are concerned about the health of the poor. In this era of globalization, India should think bigger and also look for more scientific research to compete with global leaders. " On interference by NGOs in the research activities he said, "We will face problems when non-technical people actively involved in NGOs try to interfere in the scientific activities. Some times this may force the organizations to look for alternatives." Dr Ajit Dangi, director general, Organization of Pharmaceutical Producers of India (OPPI) Fabricated Charges "The NGO which has fabricated the charges was not functional and has made wild allegations. Even the complainant has not given his/her true identity. This is only to make quick money. In this country, you see many such acts of black mailing. And this will continue. We are not giving much weightage to such false and wild allegations. We respond to limited queries. One should also understand that no one takes such allegations by this NGO seriously. This will only create bad impression about NGOs. The credibility of NGOs will be hit by these acts. The companies are taking extra precautions. All efforts are being made to launch good and quality products. " Dr M Venkateswarlu, deputy drug controller general of India (west zone) Irresponsible Act "The Indian biotech sector is in its infancy and needs nurturing and positive support. Irresponsible acts such as this are not only detrimental and deplorable but send a very wrong signal to the outside world. ABLE hopes that with the exposure of this irresponsible action, the biotech community will pledge itself to building this sector on a strong code of ethics and fair play." Ms Radhika Chaudhury, Director, Association of Biotechnology-Led Enterprises (ABLE), Bangalore Bad Name for rDNA Products The biotech head of a leading biopharmaceutical company, who requested anonymity said, "We, as a manufacturer, make all efforts to develop very good and quality products. We are responsible the people of India. I am sympathetic to the companies, which are really making efforts in developing recombinant products." Expressing concern over such frivolous acts, he said, "It would create unnecessary delay in launching genuine recombinant products into the market. I hope such acts will not repeat in future. " ]]> <![CDATA[India Gets Big in Bio Manufacturing]]> https://biospectrumindia.com/news/95/1515/india-gets-big-in-bio-manufacturing.html https://biospectrumindia.com/news/95/1515/india-gets-big-in-bio-manufacturing.html Wed, 08 Sep 2004 17:23:00 +0530 The famous line always has been that "Indian missed the bus for manufacturing destination". This may be true for other sectors, but not in the biotech sector. Walking into Hyderabad, one can see world class manufacturing centers in the campuses of Bharat Biotech, Biological E, Dr Reddy's Laboratories, Indian Immunologicals and Shantha Biotechnics to name a few. Moving into Bangalore, one would be fascinated with Biocon's plants. While Pune showcases world-class plants of Serum Institute, Delhi/Gurgaon houses impressive plants of Ranbaxy, Panacea Biotec etc. Not just that. Contract manufacturing orders too are flowing. For instance, Biocon has a suppliers contract agreement with Bristol Myers Squibb for recombinant human insulin. Bharat Biotech has a contract with Wyeth. Surely, the opportunities in biotech product manufacturing are unfurling. The demand is on the rise. According to the Department of Biotechnology, the consumption of therapeutic recombinant proteins is going to increase significantly. The consumption of human insulin is estimated to increase from 95 kg in 1997 to 270 kg in 2005. Similarly the consumption for erythropoietin, interferons and streptokinase is estimated to increase to 4 kg by 2005 from 1.5 kg in 1997 and 2 million doses by 2005 from 0.2 million doses in 1997 and 3 million doses in 2005 from just 0.5 million doses in 1997, respectively. Even the industry estimates that the market for biogenerics in India is expected to see a 43 percent jump from Rs 308.50 crore in 2001 to Rs 1,305.7 crore in 2005 and projected to reach Rs 1,864.3 crore by 2007 registering a growth of 19 percent. Recognizing this huge potential, many companies are investing significantly in their R&D activities to reap the benefits by developing indigenous biotechnology products. While some companies are entering into marketing tie-ups and signing memorandum of understandings, some are going for in-licensing agreements to market the products in India. There is no concrete data available on the investments made by the biotech companies on the manufacturing facilities. It is, therefore, not possible to give an accurate estimate of the investments made in biotech manufacturing. "However, based on the knowledge we have of the facilities built by biotech companies manufacturing biologicals and based on our knowledge of the cost of such vaccines, a very approximate estimate of the investments made would be of the order of Rs 1,000 crore," said Varaprasad Reddy, managing director, Shantha Biotechnics. This estimate does not include investments made in facilities for manufacturing fermentation based small molecule drugs such as statins, vitamins, anti-cancer agents and antibiotics. India's strengths Any manufacturing pharmaceuticals and biopharmaceuticals company would cite the following points as India's key strengths. Availability of educated and skilled manpower Proficiency in English Low capital and operational costs Proven track record in meeting international standards of quality. Added Reddy, "Many Indian pharmaceutical companies have built manufacturing facilities approved by US FDA and EMEA. Companies like Ranbaxy, Dr Reddy's Laboratories are selling generic products in a big way in the US and Europe. In the biotech sector too, the scene is similar. Serum Institute has many of its products qualified by WHO. Shantha's Hepatitis B vaccine has been qualified by WHO. In contrast, few Chinese companies sell their pharmaceutical products in the US or Europe in a big way and none of the vaccines made in China, even though there are plenty of them sold in China, are qualified by WHO. The use of English as a means of communication probably helps Indian companies follow international standards of GMP, particularly with respect to documentation and may explain, at least partly, why Indian pharma and biotech companies are ahead of their Chinese counterparts in meeting global standards." It is also no more a matter of cost arbitrage. Indian biopharmaceutical industry is going up the value chain. From being a pure reverse engineering industry focused on the domestic market, the industry is moving towards basic research driven, export oriented global presence, providing wide range of value added quality products and services. The companies, which are having business exposure to regulated markets and whose R&D activities are aligned to products going off patent are the favorites of the stock market too like Biocon. According to Dr Dhananjay Patankar, head, biotechnology, Intas Pharmaceuticals, which has recently launched a GCSF product, Nekine, in India, "There are two kinds of companies. Those specifically committed to biotechnology. Such companies will look at developing indigenous biopharmaceutical drugs. The second set of companies is that where biotechnology is not the core sector. But they want to enter this segment. Such companies will import and produce through tie-ups, in-licensing agreements, etc. Besides many multinationals sell the biopharmaceutical/recombinant products through the subsidiaries in India." As of now only few Indian pharmaceutical companies like Wockhardt, Intas Pharmaceuticals, Cadila Pharmaceuticals and Cadila Healthcare have established capabilities to develop and manufacture recombinant products. Others like Shantha Biotechnics, Bharat Biotech International have already established their footholds in manufacturing of recombinant drugs in India. Committed to Global Norms There is ample proof that the Indian companies are committed to global standards. In fact Indian companies are understood to have received the maximum number of US Food and Drug Administration (USFDA) approvals. According to some reports, outside of the US, India ranks highest with 61 USFDA-approved plants. (Italy a close second with 60, Spain 25, China 22, Taiwan 9, Israel 7 and Hungary 5). India has the largest number of annual bulk drug filings (77) with USFDA. India is home to the largest number of pharma plants approved by USFDA outside the US. Indian pharma companies have also got certification from the European and Australian drug authorities. Other international approvals include European Certificate of Suitability, MCA-UK (United Kingdom's medicine control agency), Irish Board of Medicines, TGA, Australia, completely environment friendly (ISO 14000 certified), WHO cGMP and ISO-9001 certified manufacturing facility, EC FDA, Novartis, USA and MCC of South Africa apart from local FDA. Considering the flow of applications from Indian companies, USFDA is now looking at opening its office in India. The industry sources say that soon this could become a reality. Commenting on the approvals from the certification or the approving agency from the developed nations, Dr Dhananjay Patankar said they would give the approvals for manufacturing facility or to the product. About the amount of investments a company has to make on setting up a manufacturing facility of international standard, he said, "It depends on the scale of manufacturing/products. As far as Indian companies are concerned they can meet the GMP standards. Intas has already received the approval from TGA, Australia and MHRA, UK for bulk drug production. We know the system. It won't be a problem when a company comes out with a new drug." "Cost involved in getting the product approval for the therapeutic recombinant drugs will vary as it involves three key issues-infrastructure, quality system and licensing," said Dr SD Ravetkar of Serum Institute of India. For renewal Kiran Majumdar Shaw, chairman and managing director, Biocon Ltd said, "Cost will be less." If companies are not meeting the standards set by the international agencies then it may loose the contract. Haffkine Biopharmaceuticals Corporation, a government of Maharashtra undertaking is one such example. Haffkine Biopharmaceuticals, a manufacturer and exporter of vaccines to developing countries through UN Agencies, has lost a Rs 50 crore order last year from the UN agencies due to lack of certification from international agencies. Medha Gadgil, managing director, Haffkine Biopharmaceuticals Corporation, said, "We are working on upgrading our systems so as to get back the order. Gadgil is confident about getting the next year's order. Growing Facilities With the blockbuster drugs going off patent/turning generic in the regulated markets of the US and Europe, the generic markets are on a roll. Indian companies are filing Abbreviated New Drug Application (ANDAs)/Drug Master Files to serve these markets in terms of selling formulation drugs/sourcing bulk drugs to the generic companies respectively; this is being backed by getting their facilities approved by the regulatory agencies of regulated markets namely USFDA, UKMCA etc. For example, Shantha has acquired competencies over the years to build and operate manufacturing facilities for biopharmaceuticals to international standards. Shantha has proven track record in meeting international standards of quality as its hepatitis B vaccine has been qualified by WHO. "Shantha's capabilities in R&D, QC, QA and engineering would complement much to its strengths in manufacturing. Availability of competence in biotech process development, for example, would help troubleshoot in manufacturing. Similarly competency in testing biologicals would be of help in process control and finished product testing. Built in quality standards help the company in meeting international standards of GMP," informed Reddy. Shantha now has four production suites, each about 16,000 sq.ft. in area, having class 100,000 and class 10,000 areas suitable for manufacturing biologicals. These facilities are equipped with sophisticated computer controlled fermentors (ranging from 500 Lâ€“1500 L), and downstream process equipment. One of the production suits built in 1995 is being used mainly for manufacturing hepatitis B vaccine qualified by WHO. It has a capacity to 100 million doses of hepatitis B vaccine. The other three suits built recently are for manufacturing bacterial vaccines and other microbial cell culture based products have been designed to meet USFDA and EMEA standards. These manufacturing facilities are supported by other facilities including engineering services and utilities such as captive power supply, water for injection, steam, compressed air, chilled water and oxygen supply lines, stores (8,000 sq.ft.) meeting GMP standards, QC laboratories (8,000 sq.ft.) and animal house (17,000 sq.ft.) meeting GLP requirements and an effluent treatment plant. Tulip group currently has approximately 100,000 sq.ft. of GMP approved area with around 700 manufacturing, research and quality control personnel. By the year-end, the manufacturing space would be enhanced by about 15 percent along with appropriate investments in production hardware and manpower. "With this increase, we would be comfortable to double our turnover in terms of manufacturing traffic if the market requires so. In any case, with our current capacity, we would be able to fulfill our next year's objectives of Rs 100 crore by 2004-05," said DG Tripathi, director, Tulip group of companies. Serum Institute of India, a leading biopharmaceutical company in India with a turn over of Rs 491 crore is increasing its manufacturing capacity to meet the domestic as well as international demand. Dr SD Ravetkar, senior director, Serum Institute of India said, "We are in the process of completion of doubling our manufacturing capacity. Simultaneously we are increasing our investment on R&D, human resources and infrastructure. We are investing to tune of 7-8 percent of total sales into R&D." With the acquisition of German Remedies Ltd and Banyan Chemicals, Zydus Cadila's manufacturing premises now comprise seven plants including its existing plants at Moraiya in Ahmedabad and Ankleshwar. The formulations plant at Moraiya is spread over 40 acres with a built up area of 53,000 sq.mt. This has the anti-rabies vaccine plant set up in technical collaboration with Swiss Serum and Vaccine Institute of Switzerland. It has commenced operations and the vaccines are ready for launch. The plant employs 660 people and houses warehouse facilities, quality control laboratory, formulation development and engineering departments. Bharat Biotech International Ltd has set up a state-of-the-art manufacturing plant considered to be the largest in Asia-Pacific. It sprawls over a picturesque campus at Genome Valley, Hyderabad and is built with an investment of over Rs 100 crore. According to Rajesh Jain, joint managing director, Panacea Biotec, "The manufacturing facilities are situated at New Delhi and Lalru (Punjab). A new pharmaceutical formulation plant is being set up at Baddi (Himachal Pradesh) which will comply with regulatory requirements of USFDA, MHRA, MCC-South Africa, WHO and other regulatory agencies of the world and also allow the company to avail fiscal incentives provided by the Government." In the past year, auditors and representatives of WHO visited its formulations manufacturing facility and included Panacea in the list of preferred suppliers for the global program to eliminate Lymphatic Filariasis. Panacea Biotec continued making necessary investments in upgradation of the facility to meet the requirements of natural products like ThankGod Pain and Itch Relief Cream, Toff and Awayke. Also it has invested in its existing facilities for vaccines formulation to obtain cGMP certification as per WHO guidelines. It initiated steps for setting up of new vaccine filling facility in compliance with cGMP requirements for filling of various biotechnology based injectable vaccines like Enivac HB (Hepatitis B), Trustworthy (Anthrax) and other combination vaccines including Easy Five [Pentavalent Vaccine (DTwP-HepB-Hib)] and Ecovac Tetravalent Easy Four (DTwP-Hib). Also, a new filling line separate area is being provided for pre-filled injection device in the new facility. The new facility was commissioned this year with an installed capacity of 3.25 million vials per annum. In the case of Biocon, in December 2003, its submerged fermentation facility, its second extraction and synthetic conversion facility were inspected by USFDA for production of lovastatin, simvastatin and pravastatin. It has started developing several new facilities over approximately 5 Sq.km of area. In order to meet the demand for statins, it is augmenting its fermentation, extraction, and synthetic conversions capacities. It plans to spend Rs 120 crore in the next three years for the same. Besides, it has built a new facility for recombinant human insulin production. The company is expected to spend close to Rs 300-350 crore on the manufacturing facilities in the next three years. Embracing New Patent Regime With 2005 global patent agreement round the corner smaller biotechnology companies are being driven to do innovative research and are picking niches where there is little competition. The director of Tulip group of companies, DG Tulip said, "The group would continue to consolidate its strategy of manufacturing and marketing diagnostic products and platforms to address the needs of the laboratorians both nationally and internationally. Towards this goal, Tulip continues to address its product policies, R&D and product development requirements and indigenous efforts of import substitution with locally produced raw materials. The group will continue to access international markets much more vigorously than ever before." Dr S D Ravetkar, senior director, Serum Institute of India Ltd, said, "With the product patent regime round the corner the companies should look at utilizing each other's strengths. (Just like Cipla entering into a tie up with Avesthagen for contract research). Contract manufacturing and contract research will grow with bio manufacturing trends in India." Besides indigenous manufacturing Indian companies may also look for containerization, filling contract i.e., importing in small quantity and then manufacturing in bulk. The multinationals may also take the help of contract research organizations to work on new products, entities and molecules. They also prefer to market the products in India instead of putting money on manufacturing facilities for recombinant products. However, Dr Ravetkar noted, "India should look at developing indigenous products, as it will help easy availability of the products at lesser cost. The indigenously developed recombinant drugs developed by Shantha Biotechnics and Bharat Biotech helped the consumers to avail the drugs at one-tenth the cost. It will also support the company to look at exports. That is the advantage of developing the products in house." Kiran Majumdar Shaw, chairman and managing director, Biocon Ltd informed, "Definitely the focus will be on indigenous manufacturing of recombinant drugs. In the next few years, the growth will be on account of both indigenous manufacturing and filling contract. A lot of activities are taking place on this front and many more companies will shift to bio manufacturing in the next five years. Export is also a focus area the companies are looking at." Bio manufacturing is emerging in India and the market for recombinant drugs has become fiercely competitive and price wars are common after a product launch. Along with the growth of the biomanufacturing, the allied sectors like contract manufacturing /contract research will also get a boost in India. Narayan Kulkarni with Ch. Srinivas Rao and Faiz Askari ]]> <![CDATA["India needs an integrated strategy for the agri sector"]]> https://biospectrumindia.com/news/95/1252/india-needs-an-integrated-strategy-for-the-agri-sector.html https://biospectrumindia.com/news/95/1252/india-needs-an-integrated-strategy-for-the-agri-sector.html Wed, 08 Sep 2004 15:48:00 +0530 "India needs an integrated strategy for the agri sector" Dr Clive James, founder, ISAAA Dr Clive James founded the International Service for the Acquisition in Agri-biotech Applications (ISAAA) in 1990 with the objective of spreading awareness about biotechnology in agriculture. ISAAA has recently opened a Knowledge Center in India. During his trip to the country, Dr James spoke to BioSpectrum about his views on the crop biotechnology sector. How is ISAAA's new venture in India shaping up? India is making rapid strides in agri biotechnology. In a bid to promote biotech applications in agriculture, ISAAA has formally launched a knowledge sharing initiative in India. An ISAAA South Asia office, co-hosted by the International Crops Research Institute for the Semi-Arid Tropics (ICRISAT), is now part of the network of Biotechnology Information Centers located in Asia, Africa, and Latin America. The Indian initiative would allow the country to share its experiences in agri biotechnology with the rest of the world. Partnership is the key strategy to cover more ground so that India can benefit from all the technologies that are becoming available to improve the quality of agricultural produce. What will be the focus of the Indian Knowledge Center of ISAAA? India's first hand experience could serve as a powerful example for both the developed and developing countries. Apart from this, the Knowledge Centre will be assisting national biotech programs in creating an enabling environment for crop biotech and for sound decision-making. Moreover, ISAAA will also facilitate the flow and exchange of information between all quarters of the world. We will be operating the Knowledge Center from ICRISAT's liaison office in New Delhi. What is the current status of crop biotechnology in Asia? How is ISAAA helping to improve it? Agriculture will continue to play a central role as Asia pursues the complementary goals of poverty reduction, sustainable food security, environmental conservation and increasing trade competitiveness. New technologies, including crop biotechnology, will be essential to meet these challenges. The prospects for their utilization are particularly promising, since Asia's high priority development needs and existing biotechnology potential can intersect to make a difference in the lives of its 700 million rural poor. Specifically for this, ISAAA has a Crop Biotechnology Program going on exclusively for Asia. The overall goal of this program in Asia is to help reduce rural poverty and ensure food security. This is being achieved by developing the necessary national and regional capacities to acquire, develop and safely deploy important crop biotechnology applications and products. These efforts respond to the high-priority needs of the region's countries and focus on delivering benefits to resource-poor and small-scale farmers. What are the challenges ahead of Indian agriculture? How can they be overcome? India is somewhat lacking in the food distribution system. Proper attention should be given to this aspect. An improved food distribution system can contribute a lot to food, feed and fiber security. The next challenge for India is to spread correct awareness about biotechnology among the society. And informing the society about agricultural applications of biotechnology will be the core focus of ISAAA's Indian Knowledge Center. The other challenge that I foresee is to convert the said action plans into reality. Government is showing keen interest, industry is moving towards expansion, all we need is to work on them and get them into practice. What strategy can India adopt to increase its agricultural produce? What opportunity does India have in this sector? An integrated strategy between conventional and biotechnology/GM approaches to optimize productivity along with population control can bring good changes. In simpler words, a consolidated crop management strategy is an utmost requirement for India. And as I mentioned earlier, a systemized and professional food distribution system can also help a vast country like India to achieve prominence at global platform. In terms of opportunities, India can increase investment from public sector. Another opportunity lies in the country's well-known great research potential. I think that if these things can be worked out successfully, India can be a leader in Asia. How far are issues like biosafety and technology transfer taken up at ISAAA? The ISAAA's Biosafety Initiative is aimed to support governmental commissions, policy makers, scientists and special interest groups charged with regulatory oversight to gain institutional capacity by sharing cumulative experience for biosafety with a focused training program. The intent is not to tell developing countries what to do, but to provide resource information and hands-on experience that allows each country to formulate their own system. Emphasis is placed on harmonized procedures. An essential component of pragmatic biotechnology transfer is to build long-term capacity. ]]> <![CDATA["Biotechnology is now an integral part of the product development process."]]> https://biospectrumindia.com/news/95/1654/biotechnology-is-now-an-integral-part-of-the-product-development-process-.html https://biospectrumindia.com/news/95/1654/biotechnology-is-now-an-integral-part-of-the-product-development-process-.html Wed, 08 Sep 2004 15:39:00 +0530 Amongst the galaxy of scientists of Indian origin working abroad and making India proud is Dr Mahesh Kumar, the senior director of Fort Dodge Animal Health division at Wyeth, which is one of the global leaders in pharmaceuticals, consumer and animal health care products. Dr Kumar oversees the global poultry research and development operations at Fort Dodge Animal Health. With a rich industry experience of about 14 years in the research, development and licensing of biologics, he is currently involved in the development avian biologics, management of the Transmissible Spongiform Encephalopathy (TSE) diagnostic program and the development of in-vitro diagnostic tests. Prior to this, Dr Kumar was the director of research at Maine Biological Laboratories, Waterville, US, where he developed/licensed a range of products including several unique formulations of oil-emulsion to reduce reaction while maintaining efficacy. Dr Kumar is presently on the board of directors of the Biotechnology Research and Development Corporation, Peoria, Illinois and earlier served in a similar capacity at the Center for Innovation in Bio-medical Technology, Maine. With many publications to his credit he is the inventor on several pending patents in the avian vaccine field. Dr Kumar received BSc degree in Biochemistry from the University of Madras, India, MS in Microbiology from the University of Maine, and PhD from the Minnesota university in the US. In an exclusive interview with BioSpectrum, he talks about the current trends, issues facing the animal health care industry and the role that Indian animal health companies can play in a global scenario. What are the current trends in animal health care products? How important is biotechnology in developing animal health care products? The general trend in animal health is towards safer and more efficacious products. For example, vaccines and pharmaceuticals are formulated to be less reactive in animals and designed to provide a longer duration of immunity. Biotechnology as a science has provided elegant methods and tools that aid us in the design, evaluation and development of products. Gene modifications/deletions are now used commonly to develop safer "live" vaccines. Recombinant technologies are used to create efficient means of presentation and protection against multiple antigens. The new DNA vaccine technology is also on the verge of becoming viable. Fermentation techniques are more efficient due to biotechnology allowing small molecules to be prepared in a cost effective manner. Biotechnology is now an integral part of the development process. While many applications using sophisticated biotech are possible, we are severely limited by the cost of the finished product for animals. Many of the processes are cost prohibitive and will require serious improvements in manufacturing before they are marketable. At Wyeth, the mission is to develop global pharmaceutical and health care products that improve lives and deliver outstanding value to its customers and shareholders. Our goal is to develop products that are novel and we pride ourselves in being the first against a variety of diseases over the years. Our latest achievement has been against the West Nile Virus in horses. What are the issues confronting the animal health care industry? The biggest issue we face is the change in regulations that govern the licensing and registration of products in a global economy. A product registered in the US is recognized by some countries and in due course can be registered. There are other countries that require different studies sometimes conducted locally, resulting in repeated work increasing cost and development time. The opposite is also true, where a product developed by our European group is not accepted by the USDA and requires additional studies at a minimum. In several instances they are considered exotic agents and are not allowed to be marketed in the county (even if the product is an inactivated vaccine). When we design unique products for each "region", it increases our development costs significantly. While a truly global product, where the agent is the same, was common in the past, its acceptability is becoming increasingly difficult as one is forced to demonstrate relevance of a certain strain used in the vaccine to that country. Another issue facing the industry is the Transmissible Spongiform Encephalopathy/Bovine Spongiform Encephalopathy (TSE/BSE) problem. We are required to produce products where the raw materials are certified free of TSE/BSE. While we are compliant, a new isolate anywhere, restricts the movement of products and sometimes results in trade barriers that are not science based. Other diseases such as the recent avian influenza outbreaks have had similar restrictions placed on products. What is the rate of development of animal health products and the average time frame required? On an average, in the animal health care industry, the number of products developed from discovery to final stage is approximately 1 in 5. In many cases where a company focuses on the development activities rather than discovery, it can be as low as 1 in 3, which is quite remarkable when compared to human health where only 1 in 50 make it to just the first Phase. A typical animal health biologic can take anywhere from three to five years to develop and several more to obtain registration in all the countries. What is the typical cost to make an animal health product? The average cost to develop a vaccine is around $ 1-2 million depending on the region where the product is sold. Usually the development cost for products entering the European Union is more as compared to the US. This cost approximates only the direct expenses and not the overhead expenditure. Is the animal health sector more regulated than the pharma segment? The animal health sector in the US is governed by the USDA for biologics (vaccines) and the FDA for pharmaceuticals. Though both the governing agencies have a different set of regulations, the pharmaceutical (animal) development is straight forward as the testing is mainly of the active ingredient, whereas the vaccines are unique by region and need studies that must satisfy the government officials from many countries who have unique and local requirements. However, all things considered, the human health pharma industry is probably more regulated and requires significantly more cost and development time with stricter regulations. How comfortable are animal health care companies towards outsourcing? Outsourcing services when possible is quite common and we are quite comfortable with it. We have used tollers to manufacture active ingredients when necessary and utilize contract services to conduct studies when required. A large company has to utilize any resource that is available to cost-effectively develop products. What are the strengths of Indian animal health companies and what portions of work can be outsourced to Indian companies? The obvious strength of Indian companies is the bright and well-educated workforce available in the country. The other obvious strength is the low cost of development. While some of the pharmaceutical studies could be outsourced, there are severe limitations to outsourcing biologics/vaccine related work. Import and export of strains (viruses or bacteria) for development purpose or challenge are restricted and it is difficult to obtain permits. We are forced to outsource to companies in the US or the European Union depending on whether the strains originate in our European site or the American site. Still, there are areas where one could outsource such as in formulation studies, preliminary efficacy studies, safety and stability determination studies. Many gene-based products are essentially synthetic and are not restricted as strictly as whole organisms. Indian companies can help in these processes. Microarray development for screening, primer development, etc are the other areas where they can help in product development. How will the growing opposition to animal trials from NGOs worldwide impact the rollout of new products and cutting edge research in the near future? We are committed to find alternatives to animal trials and in fact, we are the pioneers in developing in-vitro tests for batch release of products. However, we are governed by regulations that require us to conduct the pivotal safety and efficacy studies in animals. The NGO's need to push for meaningful changes at the regulatory/government side as we have to comply with the requirements in order to develop much needed products for animal health. We believe our products have improved lives by preventing major diseases in companion animals and increased the level of livestock production resulting in a major source of protein for the world. Our company is committed to investment in R&D and we will continue to rollout new products that are innovative while dealing with issues as they arise.       ]]> <![CDATA["Research Results to Business Models via IP ~ A Winding Road"]]> https://biospectrumindia.com/news/95/2554/research-results-to-business-models-via-ip-a-winding-road.html https://biospectrumindia.com/news/95/2554/research-results-to-business-models-via-ip-a-winding-road.html Wed, 08 Sep 2004 13:31:00 +0530 Every country in the world is influenced by its history and the outcome of that history becomes enshrined in the laws that govern our behaviour. In the UK Intellectual Property Rights (IPR) are largely decided by the Patent Act of 1997 and the Copyright, Patent and Design Act of 1998. Essentially these Acts give ownership of IP to the employer and places an onus on the employee to keep the employer informed of novel ideas, etc. This is a relatively facile engagement in the corporate world where organisational control is accepted but more complex and difficult to influence in the academic environment where the need of the individual to publish is considered sacrosanct. The challenges that therefore face the technology transfer specialist are cultural ones whereby apparently chaotic freedom must reconcile itself to the desire for organizational control. One particular mantra that helps when traversing this divide is that Letters Patent were originally conceived to ensure that ideas with commercial potential were not kept secret and that the public would be aware of the underlying technology (using this knowledge to advance research is thus a legitimate and laudable aim). Sheffield University Enterprises Limited (SUEL), which is a wholly owned subsidiary of the University of Sheffield, is charged with generating commercial licences and new company opportunities that arise from research activities at the university. In essence SUEL has access to the output of over 5000 active research personnel and the rights to identify, protect and exploit the resultant IPR. This relationship has, over the last 20 years (but predominantly over the last six years since SUEL came into being) generated some 50 new companies. Over the last decade, government funding for technology transfer operations in universities has been strongly biased towards company formation and regional job creation. As a consequence, in universities that rely heavily on such support to underpin their transfer initiatives, there has been a swing away from the traditional interaction with industry, that is licensing. The pendulum is now swinging back towards a more central position where the benefits of licensing and company formation are viewed together on their relative merits. The University of Sheffield and SUEL have aggressively re-visited their licensing strategy in recent years and there are currently 25 projects being actively formatted as potential licences. SUEL is currently configured to progress projects that fall into categories closely aligned to the university's known research strengths as recognised by the five yearly government review of research excellence in the UK university sector (the research assessment exercise). These categorizations also fit well with the cluster development strategy announced by the Regional Development Agency (Yorkshire Forward). At present SUEL attracts about 70 new putative commercial ideas per annum from academic staff and over 90 percent of them are carried forward for further evaluation within SUEL. At the University of Sheffield the research policy actively encourages cross-disciplinary activity and SUEL also undoubtedly benefits from accessing these boundary initiatives.At this point, when the projects extracted from the plasma generator that is the university meet the cold light of business, it is apparent that the real need is for technology translation rather than technology transfer as the cultural divide between the two environments is substantial .Academics are creative, curiosity-driven, highly motivated problem solvers who are keen to disseminate the results of their endeavours so that they may be accepted or challenged. This does not always immediately endear them to business. In the past, research lead industries found that accessing this knowledge base and getting rights to arising IP was most easily achieved via consultancies and sponsored research projects. Today there is a need to scaffold emerging technologies long enough for the employer, the employee and the customer to develop a win-win scenario. But the role of technology transfer personnel is as much about persuading, cajoling and re-iterating as it is about negotiating. To enable the necessary interactions to occur SUEL and The University of Sheffield have agreed a formal Commercial Assessment System (CAS). As earlier stated the university owns the IP generated by its employees. So the first gateway in CAS (CAS 0) takes place within the university as they have a duty of care to their employees. If the academic idea is not unduly encumbered by pre-existing relationships or key to the university's strategic intent it will be formally accepted into SUEL via one of the divisions. It is then the responsibility of SUEL personnel to work with the academic(s) to identify and protect any IP and to develop a business model. Specialist mentors may well be involved at this stage of exercise to complement SUEL staff. This activity takes place around the CAS 1 gateway and it should be emphasized that the people who operate at the CAS gates are expected to actively participate in the process. It is not a committee. Once the most likely route to market has been assessed, then formal presentation to the CAS 2 gate is made and if successful, additional business resources are made available to accelerate delivery of a spin out or a licence. The throughput of CAS is difficult to measure accurately as it is dependant upon a number of factors e.g. the material available, the number of iterations needed to properly assess potential, the discipline involved, etc. Incidentally the Japanese kanji for theSound "CAS" is also the pictogram for harmony! It is well understood that formation of a new company or indeed negotiation of a licence is not necessarily dependant upon having IP protection, but in a high tech environment where research is extremely competitive and rapidly moving it does need active consideration. Working alongside a premier research lead university means that many of the technologies, which come under review, will be of a disruptive nature rather than an incremental one so the need to take a long-term stance in respect of protection is important. Furthermore the academic drive to publish means that if patenting is an option it should be done as early as possible. Patenting strategies as employed by large private corporations often involve abandoning and re-filing as a commercial ploy but because of the publication needs of academia this is a useful option generally unavailable to SUEL. The current SUEL approach to IPR is to concentrate on patents wherever feasible and to identify the potential as early in the CAS cycle as possible. Through judicious use of qualified patent agents the earliest possible priority date is obtained and the academic groups are formally committed to an agreed patent exemplification programme for 12 months. It is also mutually agreed that failure to exemplify will result in the patent being abandoned. Advancing to full patent status is only undertaken if experimental evidence is good and a clear business strategy has been formulated via CAS. This complex relationship between SUEL and the University of Sheffield allows commercialisation of elements from the research portfolio and the processes that underpin the relationship were not arrived at overnight. They have themselves gone through several iterations. Even now it is an evolutionary process that is constantly re-adjusting to the demands of government policy, business legislation, the economic environment, etc. At the heart of it lie people skills rather than process and whilst it is an example of good practice it does not profess to be best practice and nor should it. The basic model can, in the hands of committed individuals from a range of professional backgrounds, provide the core of a technology transfer system that is team driven and adaptable to a variety of circumstances. Agilent to acquire Silicon Genetics Agilent Technologies Inc. will acquire Silicon Genetics, a leading provider of software solutions for life science discovery. This acquisition will enable Agilent to emerge as a market leader in life science informatics market. The acquisition is subject to closing conditions, and financial details of the agreement were not disclosed. "Silicon Genetics brings Agilent an outstanding informatics product portfolio and a strong team of people with extensive experience in software development, marketing, sales and support," said Fran DiNuzzo, vice president and general manager of Agilent's Integrated Biology Solutions business. A life science informatics team that will be an incubator for informatics products spanning DNA, RNA, protein and pathway applications would be formed. The team will work on developing the products of Silicon Genetics, the Agilent SpectrumMill proteomics workbench, the Agilent Synapsia informatics workbench and more. Neurome to acquire Digital Gene's assets Neurome Inc., a company which performs contract brain research for pharmaceutical and biotechnology companies besides pursuing its own in-house and collaborative research protocols, announced to purchase all the assets of Digital Gene Technologies Inc., including the TOGA technology, gene expression assays, existing datasets and know-how related to vaccine development programs. In conjunction with the asset purchase, Neurome will also acquire the entire patent estate, which includes data and discoveries generated in commercial and academic research programs with leading researchers worldwide. The acquisition will allow Neurome to expand beyond its current core technologies in quantitative molecular neuropathology to include TOGA's gene expression based surveys designed to characterize the role of important target molecules implicated in areas of important unmet medical need. TOGA is an acronym, which stands for TOtal Gene expression Analysis. BioDelivery closes Arius acquisition BioDelivery Sciences International Inc. (BDSI) has closed the previously announced acquisition of Arius Pharmaceuticals. As result of the transaction, Arius has been reorganized with and into a newly formed, wholly owned subsidiary of BDSI. Arius is a specialty drug delivery company whose portfolio of potential products will be focused on "acute" treatment opportunities for surgical and oncology patients. Computer Sciences acquires DynPort Vaccine Computer Sciences Corporation has announced the acquisition of Porton International Inc.'s interest in DynPort Vaccine Company LLC (DVC), a biopharmaceutical company focused on the development of biodefense biologics products. Formerly a joint venture between CSC and Porton International Inc., DVC has been the prime systems contractor for the Department of Defense Joint Vaccine Acquisition Program since 1997. Products in development at DVC include vaccines for botulinum neurotoxin, tularemia, Venezuelan equine encephalitis, anthrax and plague, and a therapeutic blood product, vaccinia immune globulin, to treat complications of smallpox vaccination. Bayer to acquire Roche Consumer Health Bayer announced that it has agreed to acquire Roche Consumer Health. By acquiring this business Bayer will become one of the top three over-the-counter (OTC) consumer health companies worldwide. Additionally, Bayer will acquire Roche's 50 percent share of the 1997 Bayer/Roche joint venture in the US and five Roche production sites in Grenzach (Germany), Gaillard (France), Pilar (Argentina), Casablanca (Morocco) and Jakarta (Indonesia). The OTC business of the Japanese company Chugai, in which Roche has a majority stake, is not included. The acquired business has yearly sales of around 1 billion Euros. The 2.380 billion Euro transaction is subject to approval by relevant antitrust authorities. Quintiles completes sale of dermatology assets Quintiles Transnational Corp. announced the completion of the previously announced sale of assets relating to its specialty dermatology products company, Bioglan Pharmaceuticals, to BDY Acquisition Corp., a Delaware corporation and wholly owned subsidiary of Bradley Pharmaceuticals Inc. for $188.3 million in cash, including approximately $5.4 million of direct costs for transferred inventory. Quintiles intends to use proceeds from the transaction to potentially pay down debt, to fund business growth initiatives and for other appropriate purposes. The assets sold to Bradley's subsidiary include Bioglan's interests in certain dermatology products marketed in the US. Quintiles Transnational acquired certain assets relating to Bioglan in December 2001 and March 2002 as part of its strategy to invest in pharmaceutical products or companies that need additional resources to achieve their full market potential. Chiron Acquires Sagres Discovery Chiron Corporation has acquired Sagres Discovery, a privately held company, which focuses on the discovery and validation of targets with potential application to the development of cancer therapeutics. Financial terms of the acquisition were not disclosed. "This is a unique opportunity to advance our goal of building a competitive, balanced pipeline for Chiron," said Kenneth Bair, senior vice president and head of research, Chiron BioPharmaceuticals. "Sagres has a wealth of in vivo validated targets, including kinases and antibodies, that will increase both the quantity and quality of targets available to us for development."       ]]> <![CDATA[HongKong DNA launches HybriMAX]]> https://biospectrumindia.com/news/95/5919/hongkong-dna-launches-hybrimax.html https://biospectrumindia.com/news/95/5919/hongkong-dna-launches-hybrimax.html Wed, 08 Sep 2004 13:25:00 +0530 HongKong DNA launches HybriMAX HongKong DNA Ltd has introduced HybriMAX, which is based on their discovery of flow-through hybridization principle designed for a faster and cleaner way of carrying out any type of nucleic acid and protein hybridization. HybriMAX is tailor made for an improved platform for enhancing molecular interaction, which occurs in three-dimensional volumes rather than the conventional two-dimensional surface. It requires much less samples and reagent volumes hence reducing the running cost. The product also provides optional conditions for hybridization, transfer, blotting and washing procedure. HybriMAX can provide the controlled conditions critical for the hybridization process. This can be universally applied to all cases applicable to conventional Southern, Northern, Western, Dot blot, Slot blot and Reversed dot bot techniques. Moreover, nucleic acid probes, antibodies or antigens can be deposited into the membrane to create a low-density format that is used to carry out analysis of multiple probes in parallel. Additionally, it can be used as a thermal block and incubator chamber for glass slides. Bangalore-based JH Bio Innovations is distributing this product in India. For further details, contact: info@injhindia.com Bio-Rad introduces BioPlex 2200 Bio-Rad Laboratories, a multinational manufacturer and distributor of life science research products and clinical diagnostics, introduced a new immunoassay platform called BioPlex 2200. BioPlex 2200 is one of the first clinical diagnostics system to offer multiplexing technology on a fully automated, fully integrated random access platform. Multiplexing technology is the ability to generate multiple results from a single patient sample. The BioPlex 2200 automates bead-based multiplexing, can deliver up to 2200 results per hour, and provides clinical informatics to aid in diagnosis, according to the official release. The initial tests on the system will target the autoimmune diagnostics field. Future assays in development are in the areas of serology, infectious disease, cardiac and toxicology. Bio-Rad plans to begin US market placements in the next several months following FDA review. For further details, contact: investor_relations@bio-rad.com India's first fume hood testing lab Baroda -based Gordhandas Desai Pvt Ltd (GDPL), a manufacturer of modular lab furniture, built India's first fume hood testing laboratory with a complete test set up as per ASHRAE-110 (American Society of Heating Refrigerating and Air-conditioning Engineers) guidelines. This is a unique and first of its kind set up in India for testing fume hoods as per stringent international standards. All fume hoods manufactured are type tested to evaluate its capability to safety as per the guidelines of ASHRAE-110-1995. The facility was set up last year with an initial investment of Rs 50 lakh and the company is receiving enquiries about it not only from its Indian customers but from neighboring countries as well. GDPL's complete manufacturing base at Baroda is ISO 9001-2000 certified. It manufactures the complete range of Labexcel fume hoods including bench hoods, distillation hoods, walk-in type hoods, special purpose hoods and customized hoods. The fume hoods are offered with energy efficient fume extraction systems. Also offered are imported fume hood monitors, VAV controls and laboratory room pressurization controls from Temperature Electronics, UK. Other products include the solid monolithic epoxy worktops from Durcon, USA, service valves and gas distribution systems from TOF, Italy. European make chemical resistant, energy efficient exhaust fans are available with fume extraction systems as well. For further details, contact: labexcel@gdpl.com ]]> <![CDATA[Anand Kumar, Radhika join ABLE team]]> https://biospectrumindia.com/news/95/1901/anand-kumar-radhika-join-able-team.html https://biospectrumindia.com/news/95/1901/anand-kumar-radhika-join-able-team.html Wed, 08 Sep 2004 13:17:00 +0530 Dr S Anand Kumar Radhika Choudary Arvinder Singh Dr S Anand Kumar, director, AstraZeneca Research Foundation India, has been named as the honorary director of The Association of Biotechnology-led Enterprises (ABLE). Dr Kumar has been associated with AstraZeneca Research Foundation India since 1988. Prior to which he worked as a scientist in various capacities both in India and abroad. Dr Kumar is a founding member of several biotechnology companies in India including Astra Research Centre India, Syngene International, XCyton Diagnostics and Gangagen Biotechnologies. Dr Kumar has served on the committee for commercialization of biotechnology, UNIDO Vienna, Austria, the medical biotechnology task force, Government of India and the Indo-US vaccine action program apex committee. Presently he is a member of the patent screening committee of the DBT. Radhika Choudary will join ABLE as its new executive director from September. She has been a consultant to the Karnataka State IT and BT Department. Prior to which she has had brief stints at Infosys and Texas Instruments. ABLE's former director general, Mr Nitin Deshmukh, continues to be a director but based out of Mumbai as he has moved to Kotak Mahindra Bank, Mumbai as its Head, Private Equity. Arvinder Singh Joins Perkin Elmer (India) Dr Arvinder Singh joined Perkin Elmer (India) as general manager-life sciences. Earlier he was with BD Biosciences as regional manager (Asia Pacific) for technology support and as business manager (India). Perkin Elmer (India) is jointly promoted by LabIndia, its life sciences division offers unique products and technologies for drug discovery, functional genomics, proteomics, liquid handling, high throughput screening, etc. Perkin Elmer Inc is a global technology leader in life and analytical sciences and serves customers in 125 countries. The launch of BioSpectrum Top20 The BioSpectrum Top20 issue (August 04), which carried the second comprehensive BioSpectrum-ABLE survey of the Indian Biotech Industry was launched by Kiran Mazumdar-Shaw, President, ABLE, at a press conference in Bangalore. It was well attended by over 50 media personnel. Dr S Anand Kumar, Honorary Director - ABLE, Abraham Mathew, Chief Editor - BioSpectrum and N Suresh, Editor, BioSpectrum were also present at the launch. ABLE President Kiran Mazumdar Shaw unveiling the Biospectrum Top20 issue. She is flanked by Dr S Anand Kumar, E Abraham Mathew, Chief Editor and N Suresh, Editor, BioSpectrum. A section of the media personnel at the launch. Dr Anand Kumar's induction speech on ABLE.     ]]> <![CDATA[Getting Aggressive]]> https://biospectrumindia.com/news/95/4869/getting-aggressive.html https://biospectrumindia.com/news/95/4869/getting-aggressive.html Wed, 08 Sep 2004 12:57:00 +0530 krebs With an objective to establish commercially viable biotech processes with applications in medicine, agriculture and industry, Krebs Biochemicals & Industries, a BioSpectrum Top 20 company, has made pioneering efforts in exploiting traditional microbial technology over the last decade. Fermentation technology has been central to the growth of Krebs Biochemicals & Industries (KBIL). Its expertise in the fermentation process has led the company to manufacture a broad range of products in three categories-anti asthmatic drugs, nutraceuticals and statins. Dr RT Ravi, managing director, KBIL, floated the company after his 14-year stint in this field. He gained valuable insights in a step-by-step process by first working as a scientist, then joining the industry as a researcher and later joining the corporate sector as a manager. After acquiring enough knowledge on how an industry runs, he jumped the bandwagon to start KBIL in 1991 and since then there has been no looking back. Biochemical origins The company went public in March 1994 and started the commercial production of Pseudoephedrine in 1994 at its Nellore facility. During the past ten years, the plant has been upgraded to manufacture about 300 tons per annum of Ephedrine, Pseudoephedrine and their salts. Consolidating its portfolio as a bulk drug manufacturer, Krebs later set another facility in Visakhapatnam for manufacturing cholesterol-reducing drugs like Lovastatin, Simvastatin and vitamin C. Another powerful statin, Pravastatin, is in the pipeline. "We are planning to enter the branded formulations market by next year" Dr RT Ravi is an experienced technocrat with over 20 years of experience in industrial management and consultancy. A postgraduate in science with specialization in biochemistry, he has worked as project development manager with an IFC assisted organization founded by Aga Khan Foundation viz. Industrial Promotion Services (K) Ltd., Kenya. His industrial experience covered stints with Alembic Chemicals, Jagajit Industries and EID Parry. In an exclusive chat he shares the future vision and growth strategies of the company. What is the overall vision of the company? Krebs should be recognized as a bioenergy, biopharmaceutical and R&D center. For this, we need good technical expertise and capital inflow. We are also heading towards such places where good biochemical markets are available. What are the current happenings at your R&D center at the ICICI Knowledge Park in Hyderabad? Basically, we do not have an R&D center that can support development of a new product or process, which may significantly alter the scientific knowledge and escalate the industry status. However, we try to take advantage of this center to improve our processes in a small way, by bringing out process or product variations to increase the company's product range or reduce the cost of production. But as the size of the company grows bigger, we would want to be an R&D based company. Today what we are doing production outsourcing to technology companies elsewhere, which have big R&D centers. Talks are on with a UK-based company and we may start production for them in September. But precisely, our focus would on the R&D of new bio molecules and genetically engineered products by synthetic and biological approaches. Is the company planning to diversify further in the health care segment after antiasthmatic drugs and statins? What are the new products in the pipeline? The company's experience in active pharmaceutical ingredients over the past decade has set a definite platform for venturing into the most significant and high margins segment of formulations. We are proposing to enter the branded formulations or outsourcing to US generic companies by the end of March 2005. The initial target is to venture into manufacturing of formulation for existing product range. On consolidation, the company has plans to enter therapeutic groups-both generic and patented drugs thereby increasing the toplines and bottomlines. To expand in the pharmaceutical segment it is important for us to have good manufacturing facilities and thereby we can license out the patent. So setting up of production base in India is vital. This way we can make the most of the indigenously available raw material and equally yield foreign exchange. The latest product in the pipeline is Pravastatin. This is prescribed to patients who have elevated levels of cholesterol that cannot be controlled through diet and exercise alone. The trial production is on and latest by next year, this would be out in the market. Krebs has recently ventured into biofuels. How does the company foresee future growth in this segment? Sugarcane cultivation is an efficient method of converting solar energy into stored energy. We have chosen sugarcane, the renewable source of energy, to produce food ingredients (sweeteners), fuels and industrial products (ethanol), animal nutrition (feed ingredients) and human nutrition (soluble fiber, natural antioxidant) products. It is a totally unexplored area in our country and we are investing around Rs 70 crore on this project. We are optimistic about the outputs that this industry can reap. What has been the total biotech investment in the company till date and its plans for the future? The total biotech investment involved so far is around Rs 150 crore. And the turnover for the year 2003-04 stood at Rs 101.23 crore. We are targeting an aggressive growth rate to reach the Rs 500 crore mark in the next five to six years. KBIL exports its products to about 30 countries including the US and Germany. Last year the company obtained US FDA approval for three of its API (Active Pharmaceutical Ingredient) drugs-Pseudoephedrine HCl, l-Ephedrine HCl and Pseudoephedrine Sulphate, which will add further thrust to its exports. During the fiscal year 2003-04 Krebs grossed a total turnover of Rs 101.23 crore, of which the biotech revenues were to the tune of Rs 56.89 crore. The company has a strong R&D focus. Presently its research center located at the ICICI knowledge park at Hyderabad aims at improving the product range and quality and developing alternate cost effective ways of manufacturing the existing products. Later as Krebs grows and diversifies its operations, it aims to focus on new biomolecules and genetically engineered products. A wider canvas While the company continues its pioneering efforts to be a significant international player in the bulk drugs product range, it also has identified other related growth areas of manufacturing in the post WTO regime. Thus, food processing, bio energy are major areas identified to develop as separate divisions of the company. Biofuels Leveraging its core competency in fermentation technology, KBIL is diversifying into the bioagri segment. It has chosen biofuels and its downstream products to catalyze growth. Krebs chose sugarcane as over other sources like maize or potato for biofuel production due to the availability of bagasse, which enables cheap power, a critical cost component in the fermentation process. Elaborating further Dr Ravi said, "India despite being the second largest grower of sugarcane has not been able to leverage sugarcane crop as source of carbon due to not only the government restrictions but also because of the high complexity of fermentation technology. A mastery over fermentation technology is a must for extracting the carbon source or any other derivative from these agricultural crops which can substitute any other synthetically produced product or fossil fuel with industrial application". To gain foothold in the sugar industry, it has participated in the privatization bid of Nannapaneni Venkat Rao Co-operative Sugars Ltd. Jampani, Andhra Pradesh and gained possession in December 2003. It has successfully completed the crushing season 2003-04 by crushing 69,690 million tonnes of sugarcane. And in the current season, it aims at 2,00,000 million tonnes of sugarcane and plans to increase it further to 8,00,000 million tonnes by 2005-06. Talking about the expansion plans, Ravi said, "The present capacity of 1300 TCD (Tonnes Cane per Day) of sugar crushing is slated to expand to 5000 TCD by 2005-06 generating 2,25,000 million tons of bagasse to suit the requirement for 22.5 MW power plant." The total cost envisaged for the expansion program is Rs 44 crore. The company is planning to adopt various possible measures for cane management and bring in trust among the farmers for growing sugarcane. Ethanol Production Equally, KBIL is also planning to manufacture ethanol by fermentation from sugar bearing or scratch substrates using yeast. Ethanol could be blended in various proportions in petrol. KBIL is foreseeing a definite and assured market for utilization of ethanol as a fuel and it is proposing to invest about Rs 9 crore. Setting up of 22.5 MW co-generation power plant: The viability of sugar industry is linked with the setting up of the co-generation power plant. This will run on bagasse, a sugarcane byproduct produced at the sugar plant. The power generation will be partially used for captive consumption and the balance will be sold to the third party, which happens to be AP Transco. The capital expenditure envisaged for this plant is Rs 6 crore. Future outlook As part of diversification, the company is also foraying into food industry. It has set up a plant in Gaganpahad Village, Rajendra Nagar, Hyderabad, to manufacture stackable fabricated potato chips with a capital outlay of Rs 22.2 crore with a capacity of 300 kgs per hour. The plant has a capacity to manufacture 2500 million tons chips per annum. "The prospects from the project are lucrative with a projected turnover of Rs 80 crore per annum," admitted Ravi. "The trial productions are through, and we are looking for a suitable marketing agency. We might be in the market anywhere between November 2004 to January 2005. The final product would be sold domestically and also exported," he added. CyberMedia News, Hyderabad ]]> <![CDATA[Dangerous Trend]]> https://biospectrumindia.com/news/95/1267/dangerous-trend.html https://biospectrumindia.com/news/95/1267/dangerous-trend.html Wed, 08 Sep 2004 12:38:00 +0530 The tremors created by the Public Interest Litigation filed in the Supreme Court related to clinical trials of some biotech drugs will take a long time to subside. The PIL had its beginnings in another much-publicized complaint against Shantha Biotechnics by an unknown NGO, Anikethan, to the biotech regulator GEAC, a year ago. For the PIL, by yet another equally unknown Mumbai-based NGO, ADOPH, has borrowed heavily from the complaint to GEAC. Being the first pure play biotech company, Shantha had to face the brunt of the problems associated with the government regulator's learning process in handling recombinant pharma products. The complaint raised by Anikethan related to procedural issues about the involvement of regulatory agencies. In fact, Shantha' regulatory process has been taken as the benchmark for future evaluation of such products by the regulator. However, some grey areas in the process, which became public knowledge during the long-winding regulatory approval path of the streptokinase drug has become the fodder for targeting the company through selective use of this data. In fact, the crux of the PIL filed against Biocon over the clinical trials of its insulin drug is an offshoot of the same procedural issue: whether GEAC approval for each stage of the trial is required or not, after having got the clearance from all the other regulatory agencies involved. The regulator GEAC has clearly stated that the procedural lapse in Shantha's case did not involve any mala fide intention. The approval process for any drug stretches for years and these are subjected to very stringent and evolving guidelines. In most cases, regulators approve use of these trial drugs on individuals who are left with very few alternatives and the acceptable mortality rates are based on risk-benefit analysis. There is an urgent need to share with the public the benchmark rates for adverse effects of the trials of various drugs to ensure that selective use of this data does not stymie the development process of many potential life-saving biotech drugs. What is interesting is that our society has a very ambivalent attitude towards all regulatory agencies. Regulatory mechanisms is an evolving field and in the last 15 years or so, the various regulatory agencies have gone through a very difficult learning process and many have come out with flying colors. And whenever any such regulatory agency highlights some "deficiencies" in the process followed by companies, these have become the fodder for their opponents for a negative campaign. At the same time, a well articulated view point by the regulator, clearing an organization or company, has by and large been attributed as a "motivated" decision by rivals affected by these happenings. As a result any clean chit given to a company by a regulator is rarely taken at its face value by rival players. Biotech is now becoming a victim of this syndrome. The technology has the potential to provide many path-breaking solutions to several serious issues facing the humanity. The complex nature of the technology has foxed every one, including the regulators. Many of the hurdles created by the lack of full understanding of the benefits and also the possible side-effects could be tackled only if all stakeholders work together in a spirit of cooperation. Transparency should become the cornerstone of the clinical trials process (except the commercial details) to allay public fears over the drug development process in the biotech sector.     ]]> <![CDATA[Stop talking, Just do it!]]> https://biospectrumindia.com/news/95/2778/stop-talking-just-do-it.html https://biospectrumindia.com/news/95/2778/stop-talking-just-do-it.html Wed, 08 Sep 2004 12:21:00 +0530 Indian Biotech Regulatory Reforms Close on the heels of the global biotechnology conference in Delhi sponsored by FICCI, MSSRF and ISAAA, every Tom, Dick and Harry has spoken on the need for reforming the biotechnology regulatory system in India. Some say Indian biotech regulatory system is too lax, some say it is too tough and yet some say it is inept and ineffective. Perhaps, there is some truth in all of these. But, is there a solution to the problem? There is, but not the way they are going about it. Indian bureaucracy has invented the phrase "single window" clearance system as a cure all for every ill of the permit and license raj system. It meant different things to different people. What it meant to Kapil Sibal, the Minister of State for Science and Technology when he suggested the government would have single-window system for biotechnology is anybody's guess! At least one anti-GM activist thinks that it means lessening the regulatory burden and making it easier for the industry. The rest don't think so. It simply means providing administrative convenience of sending in your biotech application through one door without having to run from pillar to post. It does not mean that all the confusion and the turf battle within and among the ministries are over. In fact, it has just begun with ICMR throwing its hat into the ring. It certainly does not mean that the regulatory review will be speeded up, as the system itself has not been designed to put a timely process in place. It will take a long time. Then, there is a suggestion that GM crops must be covered by insurance to protect the poor Indian farmer. There is also a demand for socio-economic and ethical impact assessment of the technology and the products. Can you imagine all these issues being handled by a regulatory system that was originally cobbled together to assess biosafety and environmental impact of GM crops? There is no way all these issues can be handled by a regulatory system whose ostensible purpose is to assure the public of the safety of biotechnology and its products. This is not to say that other issues are not important, but it is just that these issues should be decided by specialized experts. Socio-economic and ethical issues are best studied by academic experts and scholars. And after a thorough public discussion and discourse a suitable public policy must be evolved to determine if those issues are best handled through a regulatory regimen. For now, India is struggling to put in place a scientifically rigorous biosafety and environmental impact assessment system and that is not hard to do in this day and age with so much of resource and expertise available around the world just for asking. Biotechnology regulatory oversight is not rocket science. Countries around the world have been doing it for decades now and if India is serious, it can call in experts to put together an effective and transparent regulatory review system for GM crops quickly and get on with the business of safe biotechnology development, pronto! Almost everyone who is talking on biotech regulatory system in India has not even read an environmental risk assessment document, much less carried out one. It is no ones case that GM crops do not need regulatory oversight. The squabble is about the level of regulatory scrutiny that should be conferred on GM crops. How does one decide the level of regulatory scrutiny? By simply preparing an ex-ante risk assessment using the best possible scientific rigor and determining the specific risks and then exploring the options to manage or mitigate those risks in a cost effective way. It is equally important to assess the risks of not deploying the GM option as well. GM crops cannot and should not be considered "risky" just because some feel it is risky. All of us would be wiser to realize that regulatory oversight has a cost and it better be cost effective regulations. Otherwise, we will be denying the potential benefits of the technology by making it prohibitively expensive. To the best of my knowledge, no one in RCGM or GEAC has prepared an environmental risk assessment document for any of the of GM crops, based on which they have made their regulatory decisions so far. Surely, they have done their own "seat of the pants" review of some kind or other so far. Because it was not systematic and followed any standard methodology, it took more than six years to get the first GM Bt-cotton to the market place. Civil society groups are crying about lack of transparency and I suspect even the applicants would appreciate a dose of the same to comply with the regulatory requirements. I suspect that the lack of transparency in the system is because they cannot explain the rational for making their decisions. Having been an author of thousands of environmental risk assessments, I can confidently tell that there is no need to hide anything about regulatory decisions on GM crops, as there is nothing to hide. Both the regulators and the applicants must do everything possible to make as much data and information public as possible. Both must realize that in this day and age when the GM crop technology is under so much of fire, everyone involved must do everything possible to assuage public concerns and do not do it just to satisfy some activists. Kiran Mazumdar-Shaw of Biocon must be congratulated for her boldness to announce the other day that Biocon has made all its clinical tests data public through its website. The agricultural biotech industry should follow the lead of Biocon in this regard and earn public trust and confidence. They can really beat the activists in their game by winning over the public directly. The government is wasting its time by talking to people who are clueless about setting up a regulatory regimen. The only sane and balanced view I have heard in all this cacophony is an editorial entitled "Biotech Watchdog-A Single Regulator' a welcome idea" in the pages of The Financial Express datelined August 15, 2004 (http://www.financialexpress.com/fe_full_story.php?content_id=65882). Lobbying by one group or another to influence the regulatory system will continue, but the policy makers and administrators know better to put competent people in-charge and give them a free hand to do the right thing. The need of the hour is a statutorily independent national biotechnology regulatory commission that will serve as a policy advisory body and administer a technically competent group of regulatory experts with training in environmental risk assessment. The commission's members can be drawn from different walks of life with adequate representation from all the stakeholders to ensure transparency for which everyone is crying. It will go a long way in earning pubic trust and confidence and facilitate biotechnology development for the benefit of all. Dr. Shanthu Shantharam is the President of a biotechnology affairs consulting firm, Biologistics International in Maryland, USA. ]]> <![CDATA[Playing Tom and Jerry in Patents]]> https://biospectrumindia.com/news/95/2072/playing-tom-and-jerry-in-patents.html https://biospectrumindia.com/news/95/2072/playing-tom-and-jerry-in-patents.html Tue, 07 Sep 2004 17:35:00 +0530 With the product patent regime on the anvil, things would change and Jerry must watch out for Tom before venturing out. In the present changing scenario, two issues gain importance-acquiring patents and enforcing them. In this article, we shall examine some of the issues relating to infringement from Tom's (innovator's) perspective. The copied or accused products are usually of two types. A direct copy where the accused or the allegedly infringing product has all the features that have been claimed in the patent. In patent parlance, it is called "literal infringement"; or a variant wherein the accused product differs from the claims in one or more aspects, but is essentially derived from or inspired by the patented product. Each claim must be adequately supported in the specification by way of examples and description. If not, the claim would be invalid for "insufficiency of disclosure". After having determined that the accused product does actually infringe the claims of the patent, the next step is to prepare for the legal battle with ammunition such as particulars of the infringing product like its manufacturer and the scope of their activities in India. Under the Indian law, any act of importation, use, offering for sale, selling, marketing in any manner would constitute infringement. The criterion is whether the innovator is being deprived of the fruits of his labor and whether the invention is being used to further commercial interests. All these activities must occur within the Indian territory for an action to be taken in India. If for instance, a patent holder had an Indian process patent for a product, which is already in the public domain and the infringer prepared the product using the patented process outside India and imported the finished product into India, it would not constitute infringement of the process patent in India. In certain developed countries, preparing a product even outside their territory via a process patented in their territory would constitute infringement if it can be proved that the product was prepared by that patented process. A classic example is where the product and the process for its preparation are patented in US. An Indian company obtains the relevant literature, prepares the product via the patented process in India and exports it to US. Such an activity is likely is to invite an infringement action. In case of a process, it is often far difficult to prove the nuts and bolts of the infringing process since access to the premises of the defendant where the process is being carried out is nearly impossible, especially in India. Hence, the Patent Act, 1970 (as amended in 2003) now provides that if the product of the plaintiff is new and identical to that of the defendant and if the plaintiff is not able to obtain details of the defendant's process, then, the onus is on the defendant to prove that the process adopted by him is different from that of the plaintiff. Having gathered enough ammunition, one may approach the court (district or High Court) with a suit for infringement claiming injunction to restrain the defendant from continuing his infringing acts and damages for the loss caused by such infringement. If a prima facie case is made out, the court may grant ex-parte injunction and order seizure of goods. In conclusion, a plaintiff must take adequate care to first obtain a good patent, maintain it and then to enforce it against infringers. Mere ownership is like a half-told story. By Rajeshwari H rajeshwari@knspartners.com K & S Partners K&S Partners is a full-fledged intellectual property law firm with offices in New Delhi and Bangalore. It specializes in the entire gamut of intellectual property laws, protection and enforcement.     ]]> <![CDATA[A Vital Piece of London's Infrastructure]]> https://biospectrumindia.com/news/95/2102/a-vital-piece-of-londons-infrastructure.html https://biospectrumindia.com/news/95/2102/a-vital-piece-of-londons-infrastructure.html Tue, 07 Sep 2004 17:25:00 +0530 London Technology Network London Technology Network (LTN) is a private company under registered society (a not for profit organization) and has been in operation for 18 months now. Currently, the UK government funds LTN and the same is expected to continue for another 18-24 months. In these two years, LTN has tried to address the issue of how to turn the commercialization of technologies into reality. It has the structure, resources and the know-how to introduce a company to the person, which needs to meet with London's academic research base. It facilitates not just the companies in the UK to access London's academic base, but also those across the globe to engage with London's academics. The background is pretty interesting. About four-five years back, there were some trends in the university-industry engagements in the UK, which were seen as not favorable. There was some reduction in the industry-academia engagements by some measures. This was a considerable concern for the government. The concern was for two distinct reasons. One, this leads to funding shortfall in the colleges. Second, if industrialists were not engaging with the academics, then there was little reason for the industries to set up centers and offices within that area. But the industry was fostering around academic centers-of-excellence, especially in the areas like biotechnology. Further, there was no reason to believe that the academic centers in the UK were any worse. So the question asked was why were some of the trends of industry-academia engagements unfavorable and this was to be addressed. During that phase, London Business School (LBS) and University College London (UCL) had decided that they would form a joint venture. This was to leverage the skills of LBS and assist the UCL engage with the industry. It was to be partly funded by LBS and partly by UCL. However, the various government offices heard about it and said that this is just the kind of initiative that the third stream funding activity should be aimed at. So under one of the funding initiatives, called the Higher Education Innovation Fund, they offered to support the London Technology Network. And in return LTN had to assist all the colleges and universities in London. Today LTN has emerged as a vital piece of infrastructure in London, which helps the industry and academia to connect. It covers scientific developments in a range of technology-intensive industries including life sciences, high technology and engineering. Global companies too have espoused interest to access skills and research from London's leading universities. Its services come free too. "It is my hope that we can engage the Indian companies with London's academia and take some of these technologies into the commercial arena." - Dr Jolyon White, technology consultant, London Technology Network In July this year, Dr Jolyon White, technology consultant, London Technology Network, was in India to attend Bangalore Bio. In a freewheeling chat with N Suresh and Ch. Srinivas Rao, Dr White told BioSpectrum how LTN works and invites Indian companies to engage London Technology Network (LTN) to their advantage. What are the services that you offer? LTN is about helping any industry anywhere in the world, which has a technology-intensive component engage with the universities and academics in London. You have to tailor the service you offer according to the type of enquiry that the industry asks. The most easily understood type of problem is a company asking for carrying out a specific piece of work for a specific need. This is a relatively straightforward enquiry to handle as the academics are competing directly with CROs (Contract Research Organizations). The deeper problem though is when companies are interested in learning about things that are outside their areas of expertise. This is an area where the academics can play an important role. It is because they work in this area of core understanding and wholly defined problems. They tend to have the abilities to foresee where the new technologies can go better than somebody who is within the company and who does not have the time to consider these things. When you bring the academic together with the commercial organization, he can see where the technology is going and the commercial threat and opportunity. These are the valuable things that get incorporated into the planned strategy. Are these enquires handled differently? These two types of queries are handled differently. They are slightly different in process and very different in terms of documentation. So for the project type of enquiry, which is "I know what I do not know", we handle this effectively as a preliminary project brief. It is made of phases. These are passed to the academic communities and they respond. The expertise enquires are normally not laid out in the same way. They are laid out as a knowledge area that a company wants to know more about. In terms of process, when you feedback on a project enquiry, you feedback very precisely as to what each academic has said. The feedback on an expertise enquiry produces a technology landscape document. We lay out exactly what each of the groups in doing and it comes to the company as a single document as opposed to multiple responses. Why is it important to have an organization like LTN? London has somewhere between 40-60 academic institutions, all carrying out good technical research. They are split between London University (about 30 colleges), another 5-10 other universities and 5-10 other institutes, which are not part of any universities. All of them operate relatively autonomously and tend to have their own commercial offices for out-licensing. So the problem arises, when a company wants to find an academic in London. How does it identify him? It will be difficult even for a company, which is based in the UK, to find its way through that many colleges. For a company, which is overseas in mainland Europe or the US, it is difficult for them to spend the time to hunt around all the colleges. So an organization like LTN becomes very important because we help the companies find their academics of choice. What is your structure? We have put in place 110 people. They are called business fellows. Business fellows work for LTN half-a-day a week. The other four-and-half days a week, they do full time research. They are generally in the lecturer grade and above. They are fairly senior people and act as eyes and years of LTN. They help us understand what is happening in their circles (about colleagues) and collect information about the current, past, and future research. What is the incentive offered to the business fellows? We pay them. Besides they are keen to learn about industry. They are not necessarily entrepreneurs, but they have to be in business facing mode and have the desire to work with industry. They are carefully selected on the basis of interviews. We do this with the blessing of the institutions. Universities are both the stakeholders and resource providers. Why does the industry want to work with London? The largest chunk of the UK's research funding goes into London. On a global scale, London is probably the largest life science research community outside of the US. So it is a serious global player in life sciences research. I think this could be of great value to Indian companies too. The total funding to manage research is about $5 billion. In terms of employees, about half of the researchers would be in life sciences. The number of researchers in the top two grades in London alone would be 4,600. The other important thing to realize is that in London there are a lot of enabling technologies. I guess we set up the world's first stem cell bank. What are the top areas of expertise? Oncology, neurology and cardiovascular are the top areas. There has been some significant work in the infectious diseases area too. London is very strong on teaching hospitals. We have the two largest hospitals of Europe in London. There is a large population of 7 million people who volunteer for recruitment for clinical trial of drugs. Also as the hospital network is good, the translation of research and medicine into hospitals is another clear area of focus. And it is my hope that we can engage the Indian companies with this expertise and take some of these technologies into the commercial arena. I understand there is genuine willingness in London's colleges to find good ways to engage with companies. Companies compete on knowledge, structure and process. And they are changing the structure and processes all the time in the light of new ideas coming from the business schools. The universities have to accept the fact that companies are going to engage in different ways and different structures. What we are seeing happen in London is a number of institutions or centers being set up which run across colleges and universities. For instance the London Center for Nanotechnology spans University College London and Imperial College London. So it sits across both. That brings together a lot of skills from the two colleges. Not just main stream nanotechnology, but also people who are oncologists, neurologists, etc and thus making it an attractive center of excellence for the industry to engage with. Again, LTN can help companies, which are distant from London, engage with the London Nanotechnology Center. Are there any success stories on account of such engagements? In general terms, in the project type of enquiry, we completed a project in the drug formulation; in the medical imaging area, we completed a project for a company, which wanted some beta-site testing. There has been interest in the monoclonal antibodies, vaccinology and target identification of the drugs, including vaccines. We had about 150 enquires (till July). Of those a little over half are in research areas, and the rest are sitting in other areas like licensing, beta testing, consultancy and recruitment. At this stage we do not have hard data on the conversion rate. But I believe it is better than the rule "tenth", which most B2B operations run through. I am confident that it is greater than 10 percent. What is the modus operandi of your work? We operate a market pull model. What we want from the company is an enquiry. Think of it as a structural problem solving process. The first thing would be a need identification process and then we define and generate it. We get that down to a brief. If you like it, then we request for a proposal. We then search our database and find out which academics are likely to be interested in this enquiry. We feed the enquiry out through the relevant business fellow, who takes it to that academics and asks them to respond. The responses are generally in 100-200 words, which are then sent back to the company and then we set up the meeting for the company with the academic. At that point we leave the situation. We take no financial or intellectual property stake. It is for the academics to decide. If it is an expertise type of enquiry, in a similar front end we try and identify the need as best as we can. We do other activities as well. One, we don't just feed the business enquiry through the business fellow. We also have a password protected website that is accessible to all the 110 business fellows and technology transfer offices. This helps in capturing more responses and more success rates. Two, we run networking events. Once a month, we host an event, usually in the evening, around a theme. At these events there are about 100 people. Half of them are academics and half of them are companies. The academics are senior people and the company people are the managers. One part of the evening is dedicated to presentations and the other half is networking. At the networking, industry is asked to interact with the academia and industry-to-industry or academia-to-academia interactions are discouraged. A number of relations start that way. What's next in store from LTN? The next big activity is to establish the London Innovation Relay Centre (IRC) Network. This is an EU-funded initiative to assist in the successful exploitation of European R&D. The main objective of the network is to enhance European business competitiveness by strengthening technology and the innovation base of Europe's SMEs. There are currently 70 IRCs in 31 countries including new and existing EU member states, Iceland, Israel, Norway and Switzerland. These centers have been created to facilitate the transfer of innovative technologies to and from European companies or research departments. LTN was awarded the contract to run a London-based IRC in April 2004. This is a £3.5 million project across four years. The new London Innovation Relay Centre will increase technology transfer between Greater London and Europe by building on LTN's existing strengths. LTN will be a valuable node of the IRC Network. America Greenwood named next president of BIO Congressman James C Greenwood was named the next President of the Biotechnology Industry Organization (BIO) that represents more than 1,000 small and large companies, as well as academic and research centers. The organization uses biotechnology to develop medical, agricultural, industrial and environmental products. It has members in all 50 US states and 33 other nations. Greenwood will be taking over from Carl B Feldbaum who headed BIO since its establishment in July 1993. Feldbaum, who announced in February that he would retire this year, said, "Jim Greenwood has the broad social perspective, the passion, ability and experience to lead BIO superbly in the future. I could not be more enthusiastic in passing this baton to our industry's next generation of leadership." During the tenure of Carl B Feldbaum, BIO has grown from 16 employees and a $2.1 million budget to almost a 100 member staff with a $40 million budget. Membership has increased from 350 companies to over 1,000. BIO members are involved in the research and development of health-care, agricultural, industrial and environmental biotechnology products. BIO Chairman and Alkermes CEO Richard Pops said, "After a comprehensive search from a pool of top-level candidates, Jim Greenwood was the Board of Directors' unanimous choice to lead BIO because of his commitment to improving people's lives through science and technology and his personal leadership skills. Jim Greenwood has represented the eighth district of Pennsylvania in the US House of Representatives since 1993 and serves on the energy, commerce and education workforce committees. He previously served in the Pennsylvania House and Senate. Since 2001, Greenwood has served as chairman of the energy and commerce subcommittee on oversight and investigations. "I passionately believe in the promise of biotechnology to find cures and treatments for the diseases that force parents to watch their children suffer and die, and children to endure their parents' disintegration into the clutches of Parkinson's and Alzheimer's diseases," Greenwood said. Source: www.bio.org Maize genome sequence data made public The National Corn Growers Association (NCGA) announced that the valuable maize (corn) data is now available to research scientists working to sequence the maize genome. Ceres, Inc., Monsanto Company and DuPont subsidiary Pioneer Hi-Bred International, Inc., have transferred maize sequencing information to a searchable database on the Internet hosted at the Donald Danforth Plant Science Center. After completing a licensing agreement at NCGA, scientists can access the research at MaizeSeq. "Access to these gene sequences will help public-sector researchers more quickly develop corn plants with improved agronomic performance and profitable quality traits," said Patrick Schnable, professor and director of the Center for Plant Genomics and past chair, Maize Genetics Executive Committee. In March, NCGA announced the three industry leaders would share their corn genome sequence data, which combined with the corn sequence data already in the public domain will significantly accelerate the identification of genes within the entire corn genome. This project underscores NCGA's continued commitment to advancements through research. NCGA took a leading role in getting the Plant Genome Initiative signed into law in 1997 and continues to support this important effort. With the availability of sequencing data from Ceres, DuPont and Monsanto, the corn genome could be completely sequenced by 2007, potentially years ahead of when it would have been completed without this initiative. Source: www.biotech.ca Why not a Bangalore Technology Network?Closer home, Bangalore is an important hub of biotech activity in India. There has been a constant effort on the part of the government, industry, academia and entrepreneurs to enthuse and synergize the biotech scenario in the city and the country as well. The Bangalore Bio event, formation of the Karnataka Biotechnology Development Council (KDBC), etc. are some of the efforts in this direction. Can there be a "Bangalore Technology Network" on the lines of the LTN to provide a connect between the fledgling biotech industry and the university research? Does Bangalore require such a network? Who should spearhead this initiative? And what should be its mandate? These were the questions BioSpectrum posed to several eminent biotech personalities in the city. "If we want biotechnology to flourish in India, a technology network is certainly required. It can be a forum where the practical applications can be developed into viable business models. It can be headed by an academician in Bangalore or for that matter in India. And one name that comes to my mind is Vijay Chandru. He is an academician who ventured into the industry. But I am not sure if he has time. In academia many developments and discoveries keep happening and sometimes their true potential is not realized. The industry can bring in that perspective." Dr S Anand Kumar, director, AstraZeneca Research Foundation India, and honorary director, ABLE   "Everybody is talking about the industry-academia interaction, but I am not very clear about the role of a separate body for this purpose. Most of the Government bodies like the DST, CSIR and DBT have a cell for the same." Prof. G Padmanabhan, Honorary Professor and Emeritus Scientist, IISc.   "It is required and that is why we are here. This is exactly what we are doing." Diwakar Rao, Executive Director and Chief Executive Officer, KBDC   "I do not see the requirement of a formal structure or network. Already the government has floated many such schemes. But since the biotech industry is in its infancy, the government could subsidize the technology transfer. Academic institutions, which develop the technologies, expect good revenue from them; and rightly so, as they put in a lot of research efforts into it. To make the technology cost-effective for companies, it should be subsidized. The biotech industry is headed by people who know what they are doing. So they have an exact idea of what they require and how to get it. That is not a problem at all." Dr P Babu, President, Bangalore Genei   "An organization, very much like the LTN, that can address the following issues will be a good initiative: Find out what companies, of all sizes and shapes, need by way of new technology. Find out how academia in Bangalore can respond to this need. Get the best researchers in Bangalore together with companies worldwide on specific projects. Develop regular interest-based groups for in-depth interactions. Develop "Adda": a top quality guest- house, meetings center and watering hole where interactions can take place. The government should support this organization generously-land, money, etc., but not run it. Academia should participate but should not run it. Industry should participate and run it but not act as if it owns it! It should be located near Yelahanka/Hebbal for it to be effective. It should have started yesterday. Kiran Mazumdar-Shaw should be the Chair and Vijay Chandru should manage it." K VijayRaghavan, Director, National Centre of Biological Research Asia Japanese authorities move towards restricting cultivation of GM crops There has been a series of moves on the part of local authorities in Japan as the government of Hokkaido is looking at restricting the cultivation of genetically modified crops in open fields. The law concerning the conservation and sustainable use of biological diversity through regulations on the use of living modified organisms which was enacted in February 2004, allows the use of genetically modified organisms. Swayed by the anxiety of consumers and the fear of harmful rumors against producers, these local authorities are implementing restrictions on genetically modified crops, even though they have been approved by the national government as being safe to consume and without harmful effects on the environment. In response to such a movement, academic researchers and those in industry are voicing their opposition to these restrictions. On March 5, the Hokkaido prefectural government formulated its guidelines on the cultivation of genetically modified crops in Hokkaido. The reasons for setting forth these guidelines are stated as being the fact that "consumers harbor serious doubts with regard to genetically modified foods" and that "there is a risk that this will lead to harmful rumors concerning food produced in Hokkaido and be extremely deleterious to the image of agriculture in the prefecture". The Japan Biotechnology Association submitted a written opinion, stating that i) restricting the cultivation of crops that had been deemed safe was questionable and that action should be taken with the aim of deepening public understanding, in order to reduce their disquiet; and that ii) there is concern that there may be an adverse impact on the competitiveness of Japan's agriculture and food industry in the future, if the path towards the practical application of genetically modified crops was obstructed. Source: www.jba.or.jp Europe EuropaBio joins forces with The World Life Sciences Forum EuropaBio, representing the European Biotech Industry and The World Life Sciences Forum, BioVision have joined forces to provide a special industry track at BioVision 2005. The industry track will provide opportunities for Europe's emerging biotechnology companies to meet with leaders from some of the continent's largest pharmaceutical, chemical and food companies, who traditionally come together every two years in what is known as the Davos of Life Sciences. The World Life Sciences Forum BioVision will take place in Lyon, France from April 11-15, 2005 and will bring together leaders of science, society and industry to discuss and debate social, environmental and economic issues impacting the life sciences." We are delighted to have the opportunity to implement an Industry Track in this important event," says Johan Vanhemelrijck, Secretary General of EuropaBio. "It will allow the emerging biotech industry sector to discuss key issues at the very highest levels." BioVision has established itself as a platform for top-level dialogue between scientists, public authorities and international organizations, pharmaceutical and agri food industry executives, patient and consumer association representatives, and a wide range of representatives from society at large, including most major non-governmental organizations and leading media. EuropaBio Industry Track will provide a vital bridge between BioVision and the concurrent business-partnering event BioSquare, a unique concept pulling together the biotech industry from North America, Europe and Asia. BioSquare attracts large, medium and small sized companies via an innovative partnering platform. The needs of the 1,500 emerging biotech companies feature prominently in the EuropaBio Track at BioVision; this Track will be open to BioSquare participants. Source: www.swissbiotechassociation.ch EuropaBio appoints new board members The European Biotechnology industry association (EuropaBio) announced that Jack Huttner, Dr Bernward Garthoff, Tom Saylor and Odd Magne RÃ¸dseth have been appointed to the EuropaBio main Board. Jack Huttner is vice president, corporate communications and public affairs, Genencor International, Inc and Dr Bernward Garthoff is member of the board of management of Bayer CropScience AG. Tom Saylor is chief executive, Arecor and represents the BIA, the UK BioIndustry Association on the EuropaBio board while Odd Magne RÃ¸dseth is CEO Aqua Gen AS and chairman of the Norwegian Biotechnology Association. These appointments bring elected Board members of EuropaBio to a total of twenty-one representing large and small biotech companies based throughout Europe. Speaking on the appointments Feike Sijbesma, chairman, said, "These board members representing the full range of biotech sectors as well as large and small companies alike will strengthen EuropaBio's capacity to contribute to the European policy agenda on biotechnology and life sciences." EuropaBio, the European Association for Bioindustries, has 35 corporate members operating worldwide and 24 national biotechnology associations representing some 1500 small and medium sized enterprises involved in research and development, testing, manufacturing and distribution of biotechnology products. Source: www.europabio.org Irish to increase its R&D spend in next 5 years Irish business needs to increase its research and development spend from about one billion Euro to 2.5 billion Euro by 2010, if the country is to meet goals set by Government to put Ireland at the centre of a knowledge-based EU economy, a new report said. The claims were made in a new report to the Interdepartmental Committee on Science, Technology and Innovation which outlined a plan to increase the national spend on research and development. At present the R&D spend is only two-thirds of the EU average, while spending on research and development in the EU lags behind that in both Japan and the US. The report was prepared by a high-level interdepartmental steering group established by the TÃ¡naiste in 2003. The steering group was set up to in response to the targets agreed by Heads of State at Barcelona in 2002 to increase expenditure on R&D in the EU from 1.9 percent of GDP currently to 3 percent in 2010. Two-thirds of the increase is to come from the business sector. Launching the report, Mary Harney, minister for enterprise, said the action plan highlights that despite significant strides in increasing public investment in R&D over the last five years; the performance of R&D in key sectors of the Irish economy is low compared to leading knowledge-based economies. The plan calls for a major change in the R&D performance, particularly in the enterprise sector and calls for a number of ambitious targets to be met by 2010, including the raising of business investment in R&D from 917 million Euro in 2001 (0.9 percent GNP) to 2.5 billion Euro in 2010 or 1.7 percent GNP. Source: www.biotechnologyireland.com                         ]]> <![CDATA[EOU bonanza for Biotech Parks]]> https://biospectrumindia.com/news/95/1521/eou-bonanza-for-biotech-parks.html https://biospectrumindia.com/news/95/1521/eou-bonanza-for-biotech-parks.html Fri, 03 Sep 2004 17:47:00 +0530 EOU bonanza for Biotech Parks EOU bonanza for Biotech Parks DBT has its way as BT parks may emulate the STPI success story Key Benefits The new policy initiative of the commerce ministry is based on the strategy to identify and nurture different special focus areas to facilitate the development of India as a global hub for manufacturing, trading and services, Nath emphasized. So biotechnology has been identified as a focus area to get the benefits provided to 100 percent Export Oriented Units (EOUs). The key benefits for notified BT parks will be: 1) EOUs shall be exempted from Service Tax in proportion to their exported goods and services. 2) EOUs shall be permitted to retain 100 percent of export earnings in EEFC accounts. 3) Income Tax benefits on plant and machinery shall be extended to DTA (differential tariff area) units which convert to EOUs. 4) Import of capital goods shall be on self-certification basis for EOUs.   Commerce Minister Kamal Nath could become the darling of the biotech industry. Unveiling the country's First Foreign Trade Policy (2004-09) on August 31, Nath has conceded a long pending demand of the sector to confer the status of Export Oriented Units ( EOUs) on biotechnology parks. Dr MK Bhan has been pushing for this new status since taking over as the secretary, Department of Biotechnology (DBT) on March 1, 2004. The EOU status will provide immense benefits to BT parks and remove numerous bottlenecks in sourcing raw materials, specialized equipment and other ingredients essential for the growth of India's fast growing Rs 3,265-crore biotech industry. Following Nath's announcement, the Director General of Foreign Trade (DGFT) will notify the parks recommended by DBT as EOU. DBT will act as the nodal agency and "single window" in all matters related to approvals and permissions required for import and export of biotech products from these notified parks. As DBT has already evolved a comprehensive document on what activities constitute biotech, a lot of procedural issues that normally delay the policy implementation will not happen, a DBT official said. Three Cheers! says the biotech community "This is a very good policy move and will give a big boost for research companies. Biotech companies are largely research-oriented and need to have affordable infrastructure. BT parks with an EOUâ€“like scheme make this possible." Kiran Mazumdar-Shaw, Biocon chief and Association of Biotechnology-Led Enterprises (ABLE) president "It is good news for the biotech industry. It will bring in more entrepreneurs to invest in biotechnology parks. In early 1990's when the Software Technologies Parks of India (STPI)'s got the Special Economic Zone (SEZ) benefits, more entrepreneurs looked at STPIs to set up their shops in the IT space. After that there was no looking back for the IT industry. Similarly I see a good opportunity for the biotechnology sector. The government should immediately implement the schemes under SEZ without any further delay. Sooner the implementation better will be the growth of the industry." Bamasish Paul, head, strategic planning and infrastructure, TCG Urban Infrastructure Holdings Ltd. TCG is developing the International Biotechnology Park at Pune "Its a new opening for entrepreneurs who are interested in biotech parks. This new foreign trade policy is certainly going to open up an opportunity to explore the international market. In the near future, biotech parks of India will become more interactive with the international market. This new development will help a lot." PK Seth, CEO, Lucknow Biotech Park " It is a step in the right direction. The quantum of exports that the biotech industry is looking at the near future is huge. The biotech industry will welcome this step wholeheartedly." Utkarsh Palnitkar, director, Ernst &Young India             ]]> <![CDATA[Successful Formulations]]> https://biospectrumindia.com/news/95/2507/successful-formulations.html https://biospectrumindia.com/news/95/2507/successful-formulations.html Thu, 12 Aug 2004 18:11:00 +0530 Rank 15....................Cadila Healthcare Revenue: 55 crore Successful Formulations CEO: Pankaj R Patel Revenue: 55 crore Start-up year: 1995 Business: Production and marketing of vaccines, diagnostics and biologicals Address: Zydus Tower, Satellite Cross Roads, Ahmedabad - 380 015, Tel: 91-79-26868100, Fax: 91-79-26862366 Website: www.zyduscadila.com Vital stats Patents Number Indian 41 International 42 Incorporated in May 1995 as Cadila Healthcare Pvt. Ltd, it was subsequently converted into a public company and renamed as Cadila Healthcare Ltd in July 1996. The company is the flagship of Zydus Cadila Group. It operates in pharmaceuticals (human formulations, veterinary formulations and bulk drugs), biologicals, vaccines, diagnostics, herbal products, skin care products and OTC products. A strong player in the domestic formulation sector, Zydus Cadila markets several need-based therapies through its different core divisions. Out of the many divisions, Zydus Biogen, Zydus Vaccicare and Zydus Pathline are focusing on immunologicals, vaccines and diagnostics respectively and contribute about five percent to the total sales. Zydus Pathline is the first in India to manufacture and market the diagnostic kit to detect reproductive hormones like Preganendiol Glucuronide, Estrone Glucuronide, Follicle Stimulating hormone, etc. Cadila Healthcare has also entered into an alliance with Berna Biotech of Germany and Biosidus of Argentina, which have a considerable presence in the vaccine and biotech sector respectively. It has entered into a joint venture with US-based Onconova Therapeutics Inc., a biopharmaceutical company specializing in the field of cancer research. This agreement provides for future collaborations in research, manufacturing and marketing of products. It has also acquired stakes in German Remedies that sells tissue plasminogen activator. The company has also acquired the formulation business of Bangalore-based Recon to form Recon Healthcare. It has a joint venture agreement with Korea Green Corporation, Korea to manufacture and market recombinant Hepatitis-B vaccine in India. Zydus Cadila is investing nearly 7 percent of its turnover on research and has established Zydus Research Center (ZRC) in 2000. At ZRC a team of 200 research scientists are actively engaged in research in various disciplines. It also has a 26-bed clinical research unit to carry out evaluation of drugs in healthy human volunteers. The clinical research centre operates under strict ICH-GCP-GLP-Schedule Y guidelines and an independent ethics committee monitors the studies. At the end of 2003-04, three new molecular entities discovered by the company are in the pre clinical stage of development. Cadila is hopeful of filing its first IND in India during 2004-05. It has developed Interferon alfa â€“2B and is awaiting approvals for its launch. Many other of its biotech products are under scale up or optimization stage. Cadila Healthcare has recently developed and launched a complex typhoid vaccine. Besides, it has also developed recombinant protein products, which are presently undergoing toxicological studies. So far, Cadila Healthcare has 41 Indian patents and 42 patents in foreign countries to its credit. Out of its consolidated revenues of Rs 1170 crore, the revenue from biologicals, diagnostics and vaccines amounts to Rs 55 crore in 2003-04. ]]> <![CDATA[News August 04]]> https://biospectrumindia.com/news/95/2136/news-august-04.html https://biospectrumindia.com/news/95/2136/news-august-04.html Thu, 12 Aug 2004 16:07:00 +0530 End of a Noble Innings If the year 2003 marked the golden anniversary of the discovery of DNA structure, then 2004 will be remembered for the loss of its co discoverer, Nobel Laureate, Francis Harry Compton Crick. He died on the July 28 this year after a long battle with colon cancer in San Diego, USA. British-born Francis H Crick along with James D Watson shared the Nobel Prize in 1962 for their work on DNA structure. The duo discovered the spiral double helical structure of DNA in 1953, while working in the Cavendish laboratory in Cambridge, England. By describing its double-helix structure, Watson and Crick solved the question of how DNA, through self-replication, can pass on genetic information to subsequent generations. This achievement almost single handedly revolutionized 20th-century biology and opened the door to a modern era of genetics, medicine and biotechnology. Francis H Crick Crick and Watson subsequently suggested a general theory for the structure of small viruses. Later Crick in collaboration with colleagues proposed structures for polyglycine II, collagen and a structure for polyadenylic acid. In recent years, he concentrated more on biochemistry and genetics leading to ideas about protein synthesis and the genetic code. Francis H Crick was born in 1916 at Northampton, England. He studied physics at University College but later gravitated towards biological sciences. Interestingly, till 1947 Crick knew hardly any biology, organic chemistry or crystallography, so that much of his next few years were spent in learning the basics of these subjects. Later, in 1954, he obtained a PhD on a thesis entitled "X-ray diffraction: polypeptides and proteins". Described as one of the most brilliant and influential scientists of all time, Crick became a fellow of the Royal Society in 1959, primarily for his work on DNA, but also for his study of the structure of proteins and viruses. Since 1977, he had been living in America and working at the Salk Institute in La Jolla, California, pursuing a new goal-to understand the nature of human consciousness. Biocon posts insulin trial data on website Biotech industry leader Biocon has decided to make available the clinical trial data of its three new insulin formulations on its website, www.biocon.com with immediate effect. On July 14, 2004, Biocon had received the clearance from the regulator, the Genetic Engineering Approval Committee (GEAC) for its three insulin formulations: regular, NPH and biphasic isophane. This unique effort of sharing clinical trial data online makes Biocon the first Indian company to do so and is in keeping with the high standards of corporate governance upheld by the company. "While this practice is not mandatory, Biocon has taken this initiative in an effort to reiterate our principles of corporate governance both in spirit and practice. This step further emphasizes our core policy of transparency-capturing the ethos that constitutes the true essence of Biocon. This is one amongst the many firsts that the company has set out to achieve, " commented Kiran Mazumdar-Shaw, chairman and managing director, Biocon Limited. Biocon has created an online database to pool information from various clinical studies conducted by the company and will provide summaries of trial protocols and corresponding results. Clinical trial data will be posted on an independent section of the corporate website. Visitors can read comprehensive summaries of clinical trial protocols, peruse testing results and even see references to medical journals (as applicable) where the studies have appeared. The online posting of clinical trial data is to provide relevant information to both physicians and the general public. Ocimum licenses Genchek to US universities Ocimum Biosolutions, a leading provider of cutting-edge bioinformatics solutions and Laboratory Information Management System (LIMS) has announced that it has licensed GenchekTM, its comprehensive sequence analysis tool to University of Washington, University of Virginia, Alcorn State University and Acuity Pharmaceuticals. Ocimum's CEO Anuradha Acharya remarked, "GenchekT is our first and most mature product with almost 4 years of development work. The new version of Genchek is very comprehensive and can replace multiple tools used by researchers. We are proud to add these prestigious organizations to our list of clients. Sequence analysis is a cornerstone of modern molecular genetics, yet it is difficult to provide researchers with an experience that is meaningful and cost effective. GenchekT, a comprehensive, multi-platform, cost-effective, sequence analysis software package is capable of handling and analyzing high throughput biological data. We expect that GenchekTM will enhance their research work". Financial details of the deals were not disclosed. ]]> <![CDATA[No Glitches for Biotech in Bangalore]]> https://biospectrumindia.com/news/95/2209/no-glitches-for-biotech-in-bangalore.html https://biospectrumindia.com/news/95/2209/no-glitches-for-biotech-in-bangalore.html Thu, 12 Aug 2004 14:49:00 +0530  Events  No Glitches for Biotech in Bangalore Americans are crying hoarse about being "Bangalored" in the global information technology (IT) sweepstakes. And IT honchos in Bangalore are also talking about being "Bangalored" out of Bangalore due to the intense pressure on the Silicon City´s infrastructure. Karnataka CM Dharam Singh kick starting the Bangalore Bio 2004 Kiran Mazumdar-Shaw, Chairperson, Karnataka´s Vision Group on Biotechnology elaborating the conference objectives Biotech enthusiasts thronging the stalls in the exhibition at Palace Grounds Dr MK Bhan, Secretary, DBT, announcing the intention to formulate the National Biotech Policy. MK Shankaralinge Gowda, Secretary to Government, Dept IT, BT and S&T welcoming the guests to the event Noted rice breeder, Dr Gurdev S Khush, lighting the lamp at the inaugural function. MK Shankaralinge Gowda, Dr Gurdev S Khush, KK Misra, Korn Thapparansi, Dr MK Bhan, Kiran Mazumdar-Shaw and Jawaid Akhtar at the inaugural session of Bangalore Bio 2004. But the members of the country´s fast growing "biotech hub", also located in the Garden City can breathe easy. The new, farmer-friendly Congress-Janata Dal coalition government is all eyes and ears to tap biotechnology to help their key supporters in rural Karnataka. This was amply demonstrated at the fourth edition of India´s largest biotech industry show, Bangalore Bio 2004 in Bangalore from July 11 to 13. Chief Minister Dharam Singh was at hand to launch the event and pep talk the biotech community. "Our coalition is a pro-poor government. And we will give top priority to IT and biotechnology," he declared at the inaugural function. "I am there to help with anything to develop biotechnology in Karnataka." His predecessor SM Krishna had announced the state government´s intention to set up a Biotech Park to provide all the infrastructure facilities and the ambience required for the growth of the country. And Singh put this dream on concrete footing by announcing Rs 10 crore outlay to kick off the biotech park near the Electronic City in South Bangalore. The 100-acre park will become a reality in a few years. Singh was not averse to tapping the resources of the world for this venture. He made a specific request to the Central government to fund an Incubation Center at the proposed biotech park to stimulate the growth of the industry. The Bangalore cluster may be growing well on its own. But the government´s help will come in handy to the budding biotech entrepreneurs. Bangalore has already become a brand for biotech in the state and the country, informed the state´s Vision Group on Biotechnology head Kiran Mazumdar-Shaw. She cited the example of the Bangalore Bio event which has become bigger and bigger with each edition. This year, it was a record breaker, in spite of the postponement from the regular mid-April schedule to July due to the long-stretched national elections. "Last year saw the entry of 25 new biotech companies in to the country. Seventeen of them chose to be located in Bangalore," said Mazumdar-Shaw. There are some 240 registered biotech companies in the country. At least 110 of them are located in Bangalore. She reeled out other statistics: $ 8 million in VC investments happened in the city in 2003 and there are over 9000 people working in the city´s biotech sector. "The biotech industry´s aim is to create a million jobs by the year 2010. We are on course to achieve this target. The next years will see fresh investments of Rs 1,000 crore in Karnataka," Mazumdar-Shaw added. Praise came from foreign shores too. The German Ambassador to India Heimo Richter said, "Bangalorebio event has gained excellent reputation. The German biotech industry is in the consolidation phase and we are looking towards India to keep the costs down and tap the skill sets available here." The presence of a large talent pool, institutions like the Indian Institute of Science and the National Center for Biological Sciences were the added attractions for German companies", he informed. Support to Bangalore came from the country´s top biotech policy maker Dr MK Bhan, secretary, Department of Biotechnology (DBT). "We should make investments in places which already have a strong presence of biotech sector to maximize the value. We should concentrate on the states where all the essential ingredients are already there," he said. He implied that bioactive cities like Bangalore, Hyderabad, Chennai, Pune, Chandigarh and Ahmedabad-Vadodara were the ideal places for biotech. Dr Bhan said the government would soon set up a group of experts to formulate a National Biotechnology Policy (the need for which was highlighted by BioSpectrum in its inaugural March 2003 issue itself) and enable the growing industry to have a secure, favorable environment for growth. What importance do governments in some other countries do? It was very clear from a Japanese delegate´s presentation that the country has a highly evolved national biotechnology strategy. It has four distinct elements, according to Prof Toru Yao from the Genomic Sciences Center at the TOIN Yokohama University. The national biotech strategy envisaged doubling of the research budgets for this sector in five years and tripling of researchers. The country also aimed to fuse biotech research with nanotech and IT. Commercialization of the research developments were being given strong foundation and the Japanese government planned to make systemic changes to foster clinical research and initiate deregulation along with fiscal incentives to spur the growth of the biotech sector. Ensuring public acceptance of biotech was a key element of the strategy. This was to be achieved through education, communication and risk management strategies. Stiff targets had been set: increase biotech employee numbers to one million in 2010 from just 30,000 in 2002 and target a 25 times higher market size in six years. Certainly, Yao said Japan was looking for collaborations with Indian companies to achieve many of these goals. The conference had a good number of speakers like the famous rice breeder, Dr Gurdev Khush, Genomics expert, Samir Brahmachari, DNA fingerprinting leader Syed Hasnain, bio agri expert, Shanthu Shantharam and a host of national and international speakers. The CEO Conclave had a scintillating talk by serial entrepreneur Bala S Manian on the pitfalls to watch out for during entrepreneurship. There were plenty of business networking sideshows. The exhibition at the palace grounds drew a lot of avid biotech enthusiasts on all the three days. Many thronged the venue braving the heavy monsoon showers. It is time to move on to the next edition, which may come too soon on schedule in April 2005. Karnataka CM becomes BioSpectrum subscriber BioSpectrum gained an enthusiastic subscriber in Karnataka Chief Minister Dharam Singh. He inaugurated the exhibition, which was held as part of the Bangalorebio 2004 and visited almost all the stalls. When explained about the publishing of Bangalore´s and South India´s first exclusive national business magazine, BioSpectrum, devoted to the biotechnology sector, the Chief Minister enthusiastically become a subscriber of the magazine at the BioSpectrum stall itself.   Biotech Outsourcing Outsourcing of IT services has become an opportunity for Indian companies. Can the success story be repeated in biotech too? Yes, it was possible, argued Julia Llyod-Parks, associate director of London-based Technomark. She said typically the big pharma companies were clearly not in favor of embracing the idea of outsourcing. However, the mindset has started to change in response to slowing of drug development time and increasing costs of development. A huge annual market of $ 10 billion existed for outsourcing in the pharma drug development sector. This sector is growing at 12 percent per year and there are some 1,600 specialized Contract Research Organizations (CROs) worldwide. These are in the areas of pre-clinical and clinical segments. The big pharma companies have been looking at using biotech firms as "surrogate CROs" through alliances. However, there are very few integrated groups for outsourcing, which have expertise covering clinical, pharmacology and toxicology sectors. India is well positioned to take advantage of the opportunities in drug development. Outsourcing is the mantra, advised Sumanth Venugopal, a US-based expert. Studies indicate that by 2007 at least 18 to 20 percent of the drug development work is likely to be outsourced. By 2007, the global outsourcing market is expected to double to $ 48 billion. ]]> <![CDATA[Services Galore at Quintiles]]> https://biospectrumindia.com/news/95/2147/services-galore-at-quintiles.html https://biospectrumindia.com/news/95/2147/services-galore-at-quintiles.html Wed, 11 Aug 2004 10:11:00 +0530 Rank 12....................Quintiles Spectral (India) Revenue: 65 crore Services Galore at Quintiles CEO: Dr Farzaan Engineer Revenue: 62.55 crore Start-up year: 1997 Business: Clinical research organization Address: 3-A, Ashoknagar Bungalows behind Sundarvan, Satellite Road, Ahmedabad - 380 015 Tel: 91-79-26923303 Fax: 91-79-26924311 Website: www.quintiles.com YEAR Revenue(Rs crore) 2003-04 62.55 2002-03 38.4   Quintiles Spectral (India) is a subsidiary of Quintiles Transnational, the world's leading provider of information, technology and services to the healthcare industry. Quintiles India brings together quality, speed and low cost through client-centered project management, trained clinical and regulatory staff and a dedicated facility for clinical trial supplies storage. It provides high quality across all trials through the use of globally accepted SOP's and ICH GCP standards. The Indian government has approved Quintiles India as a commercial R&D company, an important designation that recognizes the company's contributions to the drug research industry and its status among pharmaceutical service organizations in the country. Quintiles India offers high quality clinical data management services for Phase I, II, III and IV studies in various therapeutic areas. It has been utilizing India's IT expertise to assemble a data management team in Bangalore that is trained and skilled in offering data management services in Clintrial, Oracle Clinical and various EDC platforms. The unit provides customized solutions to pharmaceutical, biotech and medical devices companies, including CRF design, database design, query management, double data entry, coding and quality control as per the global standards and at highly competitive prices. Besides, it also offers services in the areas of project management, clinical trial monitoring, regulatory affairs, drug safety, protocol development, site management, quality assurance, clinical trial supplies, data management, training and centralized ECG. Quintiles India has done studies in cardiovascular, endocrinology, infectious diseases/internal medicine, oncology and other therapeutics areas. Significantly, it has completed a diabetes study for a European sponsor and has further won three more studies from the same sponsor. It has also conducted pivotal studies on bipolar disorder and the drug has been approved based on its data. Having completed one study on Parkinson's disease, Quintiles India is presently working on two other trials on the same disease. It has also undertaken study in chronic spinal cord injury under a US FDA fast track approval. The company has done parasitology trials, bacterial keratitis studies and a large anti-diarrheal study for its European clients. Pivotal Phase III study in bacterial conjunctivitis was completed and the drug was approved by USFDA based on the Indian data. The company has expertise in conducting oncology clinical trials also. It has completed about 19 oncology studies, as part of multi-country programs for regulatory submissions. Quintiles India currently has offices in Ahmedabad, Mumbai and Bangalore. It has experience in working on over 90 clinical studies involving more than 600 sites and 13,000 patients including studies in oncology, psychiatry, neurology, anti-infectives, gastroenterology, ophthalmology, endocrinology and cardiology. It has upgraded facilities at many hospitals and provided GCP training for the investigators. In 2003-04, its revenue has increased to Rs 62.55 crore against last year's figure of Rs 38.4 crore. ]]> <![CDATA[Alliance Specialist]]> https://biospectrumindia.com/news/95/4872/alliance-specialist.html https://biospectrumindia.com/news/95/4872/alliance-specialist.html Tue, 10 Aug 2004 22:04:00 +0530 Rank 20....................Span Diagnostics Revenue: 35.62 crore Alliance Specialist CEO: Veeral P Desai Revenue: 35.62 crore Start-up year: 1972 Business: Manufacturers of diagnostics reagent and kits Address: 173-B, New Industrial Estate, Udhna, Surat - 394 210 Tel: +91-261-227 7211/ 227 7143/ 227 9583/ 227 4528 Fax: +91-261-227 9319, 366 5757 Website: www.span.co.in Vital stats Year Employees 2003-04 548 2002-03 475 2001-02 363 Modern clinical laboratory needs a variety of instruments and consumables besides reagents and kits. Span Diagnostics, a leading manufacturer of diagnostic products in India, is committed to provide as many things as possible to the clinical laboratories from its own range. Span has come of age and built a good presence in research, development and manufacturing of a plethora of in-vitro diagnostics. Headquartered at Surat, it has a license from the USFDA and is equipped with a state-of-the-art manufacturing facility. Span services end users and distributors with ready to use testing kits or customized OEM products. Span operates under different divisions to market a range of products. Industrial & Research Chemical division under the aegis of Nexus is operating as liaison for lot of international companies worldwide. As an independent division, Stimulus Specialty Diagnostics caters to medical diagnostic organizations in India through exclusive tie-ups. It operates in the field of immunology, virology, endocrinology, bacteriology, allergy and coagulation disorders and also markets the specialty range manufactured indigenously by Span. COGENT, a division of Span is focusing on the Clinical Chemistry segment and provides sales support too. The company's product range consists of three categories-diagnostic reagents and kits, instruments, industrial and research products. The diagnostic reagents and kits segment includes blood banking products, clinical chemistry reagents, hematology, infectious disease serology, autoimmunity products, histopathology and cytology products, antibiotic discs for bacterial sensitivity test, pregnancy test, laboratory accessories, chemiluminescence and other kits. The rapid pace of technological and scientific developments in the sector has made it impossible to take up development of a vast array of products under one roof. Hence the company has chosen to supplement and complement the range of its in-house products by identifying appropriate partners from other countries and entering into exclusive tie-ups for marketing, distributing and servicing their products in India. Span has a technical tie up with PATH â€“USA and Nihon Kohden Corporation, Japan. Besides, Span has entered into a marketing alliance with MP Biomedicals, USA; Associates of Cape Cod Inc., USA; Remel Inc., USA; Hitachi Chemical Diagnostics Inc., USA; Genbio, USA; Awareness Technology Inc., USA; BBI, USA; Zymed Conda, Spain. To meet the increasing needs of the customers, Span has recruited more employees and its staff strength stood at 548 in 2003-04 against 363 in 2000-01. Span has expanded its capacity by investing more on infrastructure during the last fiscal from Rs 1.4 crore (2002-03) to Rs 1.75 crore (2003-04) and also tripled its R&D investments over the previous year. Started with equity of Rs 3 crore, its annual sales for 2002-03 stood at Rs 26.77 crore down from last year's turnover of Rs 27.27 crore. However its sales have again picked up and reached Rs 35.6 crore during 2003-04. The firm's net profit that had dropped in 2002-03 has again increased in 2003-04 to Rs 2.21 crore from Rs 74 lakh in the previous year. It is expecting a further rise of about Rs 2.62 crore in profits during 2004-05. ]]> <![CDATA[Nurturing Good Health]]> https://biospectrumindia.com/news/95/2759/nurturing-good-health.html https://biospectrumindia.com/news/95/2759/nurturing-good-health.html Tue, 10 Aug 2004 22:03:00 +0530 Rank 19....................Biological E Revenue: 38.37 crore Nurturing Good Health CEO: Dr Vijay Kumar Datla Revenue: 38.37 Crore Start-up year: 1953 Business: Manufacturer of vaccines, formulations and API's Address: 18/3, Azamabad, Hyderabad â€“ 500 020 Tel.: 91-40-27617831 Fax: 91-40-27615309 Website: www.biologicale.com Vital stats Year Revenue (Rs crore) Employees 2004-05* 56.45 378 2003-04 38.37 262 2002-03 17.06 248 *projected Started in 1953, Biological E is one of the first companies in India to make critical healthcare products such as preventive immunologicals accessible to common man. It has a strong presence in sera and vaccines, oncologicals, bulk drugs, formulations and herbal products. Biological E, a key player in anti-TB drugs, has been associated with the National Immunization Program for the last 30 years by supplying DPT and TT vaccines. Biological E celebrated its golden jubilee last year. It has an illustrious history of many foreign collaborations starting from Evans of UK to the Pasteur Meriux Connaught of France & Solvay & Cie of Belgium. It was the first company to bring the Korean Red ginseng to India, an elixir that promotes good health. It was the first company to introduce life-saving anticoagulants in India. Apart from domestic retail marketing, it supplies most of the essential and life saving drugs to various government hospitals, public sector undertakings and to the Indian armed forces. The International division of Biological E provides high quality innovative products to cater to the health and well being of people worldwide. Currently it is negotiating with few companies in Nepal to sell DPT and TT vaccines. And it is in the process of supplying its products to Philippines. Besides, it is looking at entering the promising economies such as Central and Latin America, Africa, West Asia and South-East Asia. Focussing on the areas of bacterial vaccines and recombinant therapeutics, it has technical collaborations with IMTECH, Chandigarh and Indian Institute of Science, Bangalore. The company has also forayed into DNA microarray technology. In this regard, it has invested about five percent of its total sales on R&D, infrastructure and human resources in 2003-04 and continues to invest the same amount during the current financial year. The company is setting up a new R&D campus at the Shapoorji Pallonji Biotech park at Shamirpet near Hyderabad at an investment of Rs 95 crore spread over 50 acres so as to focus more on the vaccine front. The new facility is being set up as per WHO/cGMP standards and then the firm would be in a position to supply its vaccines to international institutional purchasers such as UNICEF and PAHO. The new R&D center will be operation by the end of this year. It will utilize the new facility to cater to the export market, while use the existing facility at Gaganpahad to meet the local demand. Biological E is expected to launch new vaccines like Hib for influenza, which it has developed in association with NIV, a government institute in Netherlands. The vaccine is currently in pre-clinical trials and will be ready for launch in mid-2005. With a strong team of 262, the total sales of the company have increased to Rs 80.26 crore (includes Rs 19.13 crore from vaccines, Rs 1.8 crore from antibiotics, Rs 17.45 crore biochemicals) in 2003-04 from Rs 65.63 crore (Rs17.06 crore from vaccines and biochemicals) in the previous year. To reach its set target of Rs 90.00 crore in 2004-05 it is planning to increase its work force to 378. ]]> <![CDATA[Global Customized Solution Provider]]> https://biospectrumindia.com/news/95/2898/global-customized-solution-provider.html https://biospectrumindia.com/news/95/2898/global-customized-solution-provider.html Tue, 10 Aug 2004 21:52:00 +0530 Rank 18....................Syngene International Revenue: 38.48 crore Global Customized Solution Provider COO: Dr Goutam Das Revenue: 38.48 crore Start-up year: 1994 Business: Custom research Address: 20th KM Hosur Road, Electronic City, Bangalore â€“ 560 100 Tel.: 91-80-28523430-34 Fax: 91-80-28523423 Website: www.biocon.com Vital stats Year Turnover (Rs crore) Investment (Rs crore) 2003-04 38.48 23.52 2002-03 26.25 - Year Employees 2003-04 265 2002-03 172 Syngene International, a subsidiary of Biocon established in 1994, offers customized R&D services to the pharma and biotech companies. It was the first integrated contract research organization in India in drug discovery with multidisciplinary skills in synthetic chemistry and molecular biology. It specializes in early stage drug discovery and development. The company's sales in 2003-04, which comprises of custom research services and net sales of compounds, grew by over 46 percent from Rs 26.50 crore in 2002-03 to Rs 38.48 crore in the last fiscal. Its contracts are largely based on time and material management. The growth in 2003-04 has been on account of increase in the number of clients and higher realization per scientist. The company has enrolled six of the 10 major global pharma companies as its clients. In 2003-04, it added a few companies from Japan and Australia, thus expanding its existing base from those in the US and Europe. Syngene sees a significant growth opportunity in the services sector in the future. In light of this, the company is expanding its facilities and human resources. Its new R&D facility is expected to be operation in the second half of the calendar year. This 80,000-sft facility will house research laboratories, a cGMP pilot plant for the production of Phase-I drug molecules and intermediates besides a well-equipped analytical facility complete with GC-MS, NMR and FTIR facilities. It is being readied to cater to its growing global clientele. Syngene has invested close to Rs 23.52 crore in 2003-03 on R&D, infrastructure and people. Meanwhile, in 2003-04, it registered a 52 percent growth in its staff size. In 2003-04, Syngene had 277 people, up from 182 people in 2002-03. Currently, nine percent of its staff hold PhDs and this number in 2004-05 is expected to grow to about 10.5 percent. A majority of its employees are either MSc or Mphil degree holders. This number accounts for 74 percent of the total staff. While this group is expected to grow to 245 in FY 2005, the total number of employees would go up to 335. The growth has been on account of a 13-fold increase in its custom synthesis projects. Syngene's strengths lie in the areas of molecular biology, synthetic chemistry, and informatics. In the synthetic chemistry arena, it offers low temperature chemistry services, metal mediated synthesis, asymmetric synthesis, biotransformations, parallel synthesis, chiral resolution, ozonolysis, microwave chemistry, hydrogenation under high pressure and temperature, process development and product development under cGMP. In molecular biology, its expertise lies in gene cloning and heterologous expression in various host systems such as bacteria, yeast, fungi, insect and mammalian cells, downstream processing and purification of recombinant proteins, customized construction of gDNA, cDNA, BAC libraries from varied sources, directed evolution and site-directed mutagenesis of proteins and enzymes and genetic manipulation of strains for improved productivity. ]]> <![CDATA[The Innovation Continues]]> https://biospectrumindia.com/news/95/2645/the-innovation-continues.html https://biospectrumindia.com/news/95/2645/the-innovation-continues.html Tue, 10 Aug 2004 21:49:00 +0530 Rank 17....................Shantha Biotechnics Revenue: 40 crore The Innovation Continues CEO: KI Varaprasad Reddy Revenue: 40 crore Start-up year: 1993 Business: Research, development, manufacture and marketing of biotechnology-based human health care products Address: Serene Chambers, 3rd Floor, Banjara Hills, Road No. 7, Hyderabad - 500 034 Tel.: 91-40-23608843/23548507/23543010 Fax: 91-40-23548476/23541713 Website: www.shanthabiotech.com Vital stats Year Turnover (Rs crore) Investment (Rs crore) 2003-04 40 30 2002-03 26.29 69.25   Year Employees 2003-04 476 2002-03 444   Shantha Biotechnics was founded in 1993 by Varaprasad Reddy and his pioneering zeal sparked off a biotechnology revolution in the country. Today, Shantha's business has diversified across the entire spectrum of contract research, co-development and contract manufacturing. Shantha has proven its capabilities through development of innovative biotechnologies and successful commercialization of biologicals. Shantha has successfully partnered companies like Pfizer and Baxter in India. Shantha's business in 2003-04 stood at Rs 40 crore. It was the first to have the launched a r-DNA hepatitis-B vaccine, Shanvac-B, as early as 1997. Following this, it introduced several other new products. It launched Shanferon in 2002, the world's first recombinant human interferon alpha 2b expressed in Pichia pastoris. And in 2003, it announced its third recombinant product, Shankinase, a recombinant streptokinase used for myocardial infarction. Though launched in the second half of the year in 2003, this product could not be launched commercially as it was engulfed in a controversy following the regulator's decision to relook into the matter. This product may be commercially introduced this fiscal. Shantha's Indian hepatitis B vaccine is pre-qualified by World Health Organization (WHO). This business accounted for over 86 percent of its total sales. It expects to see 65 percent growth in the hepatitis business this fiscal. Besides vaccines, interferons and contract research services are the other important business segments. The interferon sales in 2003-04 are estimated to be Rs 2 crore and that from the R&D services at Rs 3.5 crore. It has a good pipeline in recombinant therapeutics, vaccines and monoclonal antibodies. Shantha's research mainly covers the generic biopharmaceuticals and vaccines, new generation biologicals, and platform technologies for therapeutic antibodies. The research staff account for 18 percent of its total manpower and the company has over 15 PhDs. During the year, Shantha's total investments were Rs 30 crore. It has a 150,000 sq. ft. facilities with a 40,000 sq. ft R&D center. This R&D center is equipped with quality instruments and infrastructure, including 8000 sq. ft. of class 10,000 area. Besides R&D, Shantha has proved itself as a quality manufacturer. Its manufacturing facility is WHO-cGMP standards complaint and includes fermenters with automatic computer controls, separate areas of API manufacturing and fill and finish, downstream purification equipment consisting of cell harvesting and cell disruption systems, chromatography, micro-filtration, ultra centrifugation and sterile filtration systems. Shantha's exports too have been growing. It registered 30 percent growth in exports in 2003-04 over the previous year. Its total exports were Rs 15 crore. It exports to markets including Asia-Pacific, Africa, CIS and Latin America. This is in addition to supplies to various government immunization efforts and United Nations agencies like UNICEF. It is also in the process of identifying marketing partners for Europe and the US. This year, the company aims to double its revenues. And towards that the company is likely to increase its manpower to 600 from the current 475. ]]> <![CDATA[The Bt Cotton Pioneer]]> https://biospectrumindia.com/news/95/1933/the-bt-cotton-pioneer.html https://biospectrumindia.com/news/95/1933/the-bt-cotton-pioneer.html Tue, 10 Aug 2004 21:47:00 +0530 Rank 16....................Mahyco-Monsanto Biotech Revenue: 54 crore The Bt Cotton Pioneer CEO: Dr MK Sharma Revenue: 54 crore Start-up year: 1998 Business: Marketing Bt cotton seeds Address: 221/224, Midas, 2nd Floor, Sahar Plaza, Madhu Vanasji Road, JB Nagar, Andheri (E), Mumbai - 400 059, Tel: 91-22-28377040/20, Fax: 91-22-28356586 Website: www.monsanto.com Vital stats Year Bt cotton# (in hectares) 2004-05* 300,000 2003-04 92,000 2002-03 38,038 # area under cultivation * Projected Maharashtra Hybrid Seeds Corporation (Mahyco) and Monsanto India formed a 50:50 joint venture called Mahyco Monsanto Biotech (India) Ltd (MMB) to market Bacillus thuringiensis (Bt) cotton hybrid seeds. Named as Bollgard, these hybrid seeds were developed by Monsanto. This joint venture was formed after Monsanto acquired 26 percent stake in Mahyco, involved in developing quality hybrids. The Genetic Engineering Approval Committee (GEAC), a key biotech regulator and part of the Ministry of Environment and Forests had permitted the three varieties of first genetically modified cotton, MECH 162, MECH 12 and MECH 184, for commercial cultivation in March 2002 in 70 districts in six states of south, west and central zone of India. At MMB the field and marketing staff are equally distributed between Mahyco and Monsanto India. MMB has sold the entire production of Bt cottonseed that it had produced for distribution during 2002 at a price of Rs 1,600 per packet. In response to the mixed reaction for the first year's launch of Bt cotton crop, MMB commissioned AC Nielsen to study the benefits of Bollgard in the second year of trials. The study revealed that the marginal farmers gained the most from Bollgard against the medium and larger farmers. It also observed that the farmers cultivating Bollgard appreciated the tangible benefits of technology with reduction in pesticide for bollworm by 60 percent and increase in net profits for farmers by 78 percent. Inspite of a mixed reaction for Bollgard in the first year of sales, the company was able to increase its sale in 2003. Bollgard sales have increased to 216,000 packets in 2003-04. The sales revenue for the year stood at Rs 34.56 crore, while its total business on account of sale, royalty and co-licensing was Rs 54 crore. MMB is also bullish for the current year as the area under Bt cotton hybrid is expected to reach 300,000 hectares as against 38,038 hectare in 2002-03 and 92,000 hectare in 2003-04. However MMB has to take approval from GEAC for the next year as the earlier approval to sell Bollgard was for three years starting from 2002. Meanwhile, on July 15, 2004 GEAC has approved extensive trials and commercial production of several hybrids of Bt cotton. The approved Bt cotton hybrids include the ones developed by Mahyco-MRC 6304 Bt for central zone and MRC 6918 Bt and MRC 6928 Bt for south zone containing Cry 1Ac gene (MON 531) and MRC 7326 BG-II, MRC 7301 BG-II, MRC 7160 BG-II and MRC 7201 BG-II for central zone and south zone containing stacked genes Cry 1Ac gene and Cry 2Ab gene (Bollgard II). Besides Mahyco, GEAC has given the green signal for large-scale field trials and seed production for 12 varieties of Bt cotton hybrids developed by Rasi Seeds and Ankur Seeds. These Bt cotton hybrids contain the Bt cry 1 Ac gene developed by Monsanto. While Mahyco is Monsanto's partner in India, Rasi Seeds and Ankur Seeds are the sub-licensees of Monsanto. ]]> <![CDATA[Value Added Fermentation]]> https://biospectrumindia.com/news/95/1234/value-added-fermentation.html https://biospectrumindia.com/news/95/1234/value-added-fermentation.html Tue, 10 Aug 2004 19:43:00 +0530 Rank 13....................Krebs Biochemicals & Industries Revenue: 56.89 crore Value Added Fermentation CEO: Dr RT Ravi Revenue: 56.89 crore Start-up year: 1991 Business: Active pharmaceutical ingredients Address: 401/ 402, Cyber Heights, 4th Floor, Plot No 13, Road No. 2, Banjara Hills, Hyderabad - 500 033, Tel.: 91-40-55593678/55594798/55595502 Fax: +91-40-23540320 Website: www.krebsbiochem.com YEAR Turnover (Rs crore) 2003-04 56.7 2002-03 55.31 2001-02 36.66 2000-01 47.63 YEAR Exports (Rs crore) Domestic (Rs crore) 2003-04 5.14 51.56 2002-03 39.25 16.06 2001-02 31.33 5.33 2000-01 34.34 12.29 Hyderabad-based Krebs Biochem-icals & Industries Limited (KBIL) is a biochemical company engaged in the manufacture of active pharmaceutical ingredients with its product portfolio comprising of statins (lifestyle drugs), nutraceuticals and anti-asthmatic groups through fermentation technology. Incorporated in December 1991, KBIL commenced its commercial operations at the Nellore facility in the year 1994 with an installed capacity of 60 TPA (Tons per Annum) of Pseudoephedrine Hcl. KBIL went public with an IPO in March 1994 to part finance the project. The company increased its production capacity from this facility to 150 TPA by 1996 and the current manufacturing capacity is about 300 TPA. Products manufactured at this facility are Ephedrine, Pseudoephedrine and their salts. The firm has set up its second unit at Kothapalli in Visakhapatnam to manufacture a basket of fermentation products such as Lovastatin, Simvastatin etc., (all cholesterol reducing agents). It has launched the production of Vitamin C through fermentation process from this unit and is now producing and marketing Lovastatin, Simvastatin and Vitamin C. KBIL's products are exported to countries like the US, Germany and also to about 30 others. KBIL's exports constitute more than 85 percent of its sales. To launch innovative products, KBIL is focusing on the research and development of new biomolecules and genetically engineered products by synthetic and biological approaches at its R&D center located at ICICI Knowledge Park near Hyderabad. KBIL has achieved a turnover of Rs. 101.23 crore in 2003-04 as against 101.50 crore in the previous year with a gross profit of Rs. 30.71 crore and net profit of Rs. 13.51 crore as against Rs.29.38 crore and Rs.14.87 crore respectively in the previous year. Of the total sales of Rs 101.23 crore during 2003-04 the total biotech revenues of KBIL for the year stood at Rs 56.89 crore including Psuedoephedrine (Rs 23.33 crore), Ephedrine HCL (Rs 5.59 crore), Lovastatin (Rs 14.32 crore), Simvastatin (Rs 13.65 crore). The profitability is affected mainly on account of slowdown in the movement of anti asthmatic segment drugs, namely ephedrine and pseudoephedrine and increase in the raw material costs (molasses) and drop in the sales price of some of the products. However with the substantial restructuring of the plant at Kothapalli in Visakhapatnam), the turnover has increased significantly from Rs 32.45 crore in the previous year to Rs 49.90 crore in the current year. KBIL has initiated steps to diversify into other activities. In this direction it has identified bio fuels and its down stream products to catalyze the growth. It was a successful bidder for the Jampani and Kovur co-operative sugar mills and completed the crushing operations in the Jampani unit for the season in 2003-04. However, the handing over of the Kovur unit is yet to be completed. It has also diversified into food products by setting up of stackable potato chips unit with a capacity of 1800 MT per annum. The commercial operations will commence in the second quarter of the current financial year. ]]> <![CDATA[The Enzyme Leader]]> https://biospectrumindia.com/news/95/2455/the-enzyme-leader.html https://biospectrumindia.com/news/95/2455/the-enzyme-leader.html Tue, 10 Aug 2004 17:28:00 +0530 Rank 11...................Novozymes South Asia Revenue: 65 crore The Enzyme Leader CEO: Steen Riisgaard Revenue: 65 crore Start-up year: 2000 Business: Industrial enzymes Address: #16, 7th Floor, Innovator, International Technology Park, Whitefield Road, Bangalore - 560 066 Tel: 91-80-28418275 Fax: 91-80-28410451 Website: www.novozymesbiotech.com Novozymes is a leading producer of enzymes and microorganisms using biotechnology. The company is based in Denmark and is a sister concern of Novo Nordisk. In India, Novozymes is represented by Novozymes South Asia Pvt Ltd (NSAPL), located in Bangalore. Through a wide network of sales and marketing professionals, NSAPL is exploring the Indian market for the product range offered by Novozymes. The company provides a variety of natural solutions to industrial problems. Based on an advanced biotech platform the company produces and sell more than 500 enzyme products in 130 countries. Since its inceptions in 1941, Novozymes has introduced almost every new industrial enzyme for the market. The company spends 11-13 percent of its sales on R&D and 15 percent employees work in R&D. Novozymes has more than 600 products for various industries. The evolution of Novozymes started when two Danish pharmaceutical companies Nordisk Gentofte A/S and Novo Industries A/S, established in 1921 and 1925 respectively, were merged in 1989 into Danish Novo Nordisk A/S. In November 2000, Novozymes was established by its demerger from Novo Nordisk A/S. Before November 2000, the Novozymes business in Novo Nordisk A/S was a division called Enzyme Business. The company has an extensive patent portfolio with more than 4,200 active patents, patent applications and licensed patents. And it is continuously and proactively seeking partners to license or in-license patents within the company's interest areas. As a part of the company's business strategy, enzymes will continue to attract about 90 percent of its research resources. Based on biotech competences and technologies, the business strategy also includes initiatives outside the core enzymes business. In the microorganism segment, through a series of acquisitions, Novozymes has become a world leader and will continue to expand in this field by introducing a series of new products and applications. For biopolymers and pharmaceutical proteins market, with the acquisition of BioGaia Fermentation in 2002, Novozymes obtained the backbone for production of pharmaceutical proteins. By the end of 2004, the company is expecting to launch its first biopolymer product, hyaluronic acid, for cosmetics use. Novozymes will also explore the potential of technologies in other areas such as antimicrobial peptides. The company is very open to the idea of collaborations in its areas of operations. In partnership with customers, technology leaders and other stakeholders, 3,900 employees at Novozymes use nature's diversity and advanced biotech platform to make enzyme solutions available to businesses everywhere. However, the company strongly believes in a future scenario where its biological solutions will create the necessary balance between better business, cleaner environment and better lives. Novozymes calls it the industrial evolution. According to market sources, the company has clocked sales of nearly Rs 65 crore in India in 2003-04. ]]> <![CDATA[Powering Ahead with Humulin]]> https://biospectrumindia.com/news/95/1236/powering-ahead-with-humulin.html https://biospectrumindia.com/news/95/1236/powering-ahead-with-humulin.html Tue, 10 Aug 2004 17:27:00 +0530 Rank 10...................Eli Lilly And Co. (India) Revenue: 67.46 crore Powering Ahead with Humulin CEO: Rajiv Gulati Revenue: 67.46 crore Start-up year: 1993 Business: Marketing of pharmaceutical products. Address: Plot no-92, Sector 32, Institutional Area, Gurgaon - 122 001 Tel: 91-124-223000 Fax: 91-124-2823012 Website: www.lilly.com Vital Stats: YEAR Employees 2003-04 537 2002-03 520 2001-02 404 Eli Lilly and Company, based at Indianapolis, USA, is a global pharmaceutical leader. It is one of the Fortune 500 companies. Eli Lilly employs more than 43,000 people worldwide and markets its medicines in 146 countries. At the global level, Eli Lilly has an image of an innovation-driven pharmaceutical corporation, developing a growing portfolio of pharmaceutical products, by applying the latest research from its very own worldwide laboratories and from collaborations with eminent scientific organizations. Eli Lilly & Company (India) is a 100 percent subsidiary of the parent company. It came to India in 1993 as a 50:50 joint venture with the Indian drug major, Ranbaxy Laboratories. This venture was primarily set up for manufacturing and marketing of select drugs of Eli Lilly and Ranbaxy in the markets of India, Nepal, Sri Lanka, Bhutan and Maldives. Later, Eli Lilly acquired the 50 percent equity stake of Ranbaxy and converted it into its wholly owned subsidiary. The biotech turnover of Eli Lilly (India) was Rs 67.46 crore in 2003-04. The company is targeting to achieve Rs 94.52 crore from its biotech business in the current year. The total turnover of the company was Rs 141.39 crore in 2003-04. Out of its biotech turnover, the major chunk of sales revenue came from Human Insulin. This product alone has generated revenues to the tune of Rs 56.59 crore in 2003-04. Eli Lilly sold over 370,000 units of its insulin drug and nearly 50,000 units of other products like Insulin Lispro, Somatropin, Drotrecogin Alfa and Teriparatide in 2003-04. The Indian subsidiary has increased the employee strength to 537 from 520 last year, majority of whom have a scientific background. The company has indigenized the r-DNA Human insulin and named it as Huminsulin, which was previously being imported in fully finished form. Currently it is being formulated at MJPL, Gujarat. Eli Lilly India has been identified as one of the highest performing organization in the Watson Wyatt survey. In the critical care area, Lilly's product Xigris is probably the only treatment option for severe sepsis. Similarly in oncology, it offers a safe and effective therapeutic option, Gemcite, for lung, pancreatic and bladder cancer. And for cardiovascular patients it has ReoPro, a drug that is used as an adjunct to PTCA (angioplasty). These segments are the major growth areas for Eli Lilly India. The other products introduced by Eli Lilly India are Distaclor, an oral cephalosporin antibiotic to treat bacterial infections in both adults and children for treating infections of chest, ear and throat; Fotreo for the treatment of men and postmenopausal women with osteoporosis; Vancocin, an antibiotic for treating severe infections; and Humatrope for the long-term treatment of pediatric patients having growth failure due to inadequate secretion of normal endogenous growth hormone. The company is presently conducting nearly two-dozen clinical trials of its various products, which are in advance stages of development. It is spending more than 10 percent of its annual turnover on clinical trials in India. ]]> <![CDATA[Value Enhancer in Biotech]]> https://biospectrumindia.com/news/95/2076/value-enhancer-in-biotech.html https://biospectrumindia.com/news/95/2076/value-enhancer-in-biotech.html Tue, 10 Aug 2004 17:26:00 +0530 Rank 9...................Bharat Serums and Vaccines Revenue: 79.68 crore Value Enhancer in Biotech CEO: Dr Bharat Daftary Revenue: 79.68 crore Start-up year: 1971 Business: Diagnostics, human health and vaccines Address: 16th Floor, Hoechst House, Nariman Point, Mumbai - 400 021 Tel.: 91-22-56560900 Fax: 91-22-56560901 Website: www.bharatserums.com YEAR Revenue(Rs crore) 2003-04 79.68 2002-03 58 Bharat Serums and Vaccines (BSV), started by Dr Vinod G Daftary, is a fast-growing biopharmaceutical firm focusing on research in Novel Drug Delivery Systems (NDDS) and equine products. Since its inception in 1971, BSV has worked ceaselessly to research, develop, manufacture and market specialized biological, pharmaceutical and biotechnology products. BSV is investing about seven percent of its total revenue in R&D infrastructure including high quality laboratory facilities, experienced research scientists and personnel. Its R&D activities have been granted recognition by the Department of Scientific and Industrial Research. The University of Bombay has also granted recognition to its R&D laboratory as a center for postgraduate and doctoral research in microbiology, applied biology and biochemistry. It also got the approval and accreditations from the World Health Organization (WHO) and the Drug Controller General of India (DGCI) to manufacture pharmaceutical products. BSV has distinct R&D divisions working extensively on NDDS and biotechnology. The thrust of R&D in the previous years has been on NDDS, especially injectibles, in the areas of anesthesia, anti-fungals and oncology. In biotechnology, its teams have been working on developing new generation recombinant therapeutics that replaces the traditional plasma products, which are in short supply worldwide. BSV manufactures and markets plasma, pharma and biotechnology products. It was primarily set up to export plasma derivatives to the US, Europe and Japan. Today, BSV has developed considerable market strengths in the domestic markets through its portfolio of niche primary line, life saving injectibles. It remains focused on ascending the value chain in the manufacturing and marketing of biological, pharmaceutical and biotechnology products and is committed to enhancing the sales of these products. BSV has a portfolio of 25 brands, most of them having the potential for marketing in the global market. Exports would continue to propel its growth in the coming years. The Group has promoted ventures in clinical research, diagnostics and therapeutic enzymes through other associate ventures, namely Siro Clinpharm Private Limited, an early entrants in the contract clinical research business in India; Advy Chemical, a partnership firm, founded to develop, manufacture and market bulk immuno-diagnostic reagents such as polyclonal antibodies, antigens, calibrators and controls; and Mucos Pharma (India) Private Limited, a joint venture between Mucos Pharma GmbH & Co., Germany and the Daftary family, which manufactures and markets specialized therapeutic enzyme products developed by Mucos, Germany. The sales turnover of the company for the year 2002-03 stood at Rs 72.37 crore. The company has been doing well in terms of its financial results by improving the sales from Rs 46.41 crore in 2000-01 and Rs 57.34 crore in 2001-02. In 2003 â€“04 it has introduced streptokinase, urokinase, low molecular weight heparin, anti rabies serum and anti thymocyte globulin. Its sales from biotech/biological products were Rs 79.68 crore of the total sales of Rs 86.20 crore. ]]> <![CDATA[Providing Healthcare Solutions]]> https://biospectrumindia.com/news/95/2285/providing-healthcare-solutions.html https://biospectrumindia.com/news/95/2285/providing-healthcare-solutions.html Tue, 10 Aug 2004 17:25:00 +0530 Rank 8...................GlaxoSmithkline Pharmaceuticals (India) Revenue: 80 crore Providing Healthcare Solutions CEO: S Kalyanasundaram Start-up year: 2001 Revenue: 79.68 crore Business: Engaged in procurement and sale of vaccines Address: 252, Dr Annie Besant Road, Worli, Mumbai - 400 025 Tel.: 91-22-24959595 Fax: 91-22-24939744 Website: www.gsk-india.com G laxoSmithKline Pharmaceuticals is one of the largest multinationals in the Indian pharmaceutical industry. It started as a trading house in 1919, became Glaxo Laboratories in 1950's and started the primary production of vaccines at Worli in Mumbai in 1956. After four years it opened the manufacturing facility for pharmaceuticals. In 1957, it began manufacturing vitamin A and betamethasone at a new plant at Thane using imported raw materials. Glaxo Labs became a limited company in 1968 and introduced animal health products. It set up its R&D laboratory at Thane in 1971. The Glaxo Laboratories became Glindia Limited in 1987 and after two years its name was again changed to Glaxo India Limited. In 2001 Glaxo India Limited and SmithKline Beecham Pharmaceuticals (India) Limited merged to form GlaxoSmithKline Pharmaceuticals Limited. Other than pharma, GlaxoSmithKline Pharmaceuticals has two other businesses -Agrivet Farm Care (AFC) and Qualigens Fine Chemicals (QFC). AFC is the major player in the animal health sector with an estimated market share of 10 percent. It has a significant presence in the cattle segment and also markets a range of specialized poultry products. Agrivet manufactures and markets high quality, safe and effective feed supplements and medicines for livestock, poultry, sheep, equine, canine and aquaculture. In 2000 it has entered into a tie up with Merial, the world's largest animal health company, to market poultry vaccines. QFC has an estimated market share of 29 percent in the laboratory chemicals market. It also has a significant presence in the diagnostics business. QFC has entered into tie-ups with leading international names in diagnostic kits to market products that give clinicians strong support in diagnosis. These include serodiagnostic and biochemistry kits. It introduces new technologies in these areas. GlaxoSmithKline (GSK) has three manufacturing units in India, located at Thane, Nasik and Mysore. The 2000 strong field force, backed by a nation wide network of over 4000 stockists, ensures that the products are readily available across the nation. This combined with the quality of the products means that GSK is able to strengthen the hands of doctors by offering superior treatment and healthcare solutions. Glaxo-SmithKline produces a range of vaccines that protect against the different infectious diseases. The company is presently working on a range of recombinant therapeutic drugs. Its sales from the vaccines division stood Rs 80 crore for the year ending December 2003 and looking at crossing over Rs 120 crore for the year ending December 2004. The company is set to post healthy growth in the domestic market with products aligned in its parent portfolio. These may make an entry into India in a product patent regime that comes into effect from January 2005. ]]> <![CDATA[Biopharma Thrust Pays]]> https://biospectrumindia.com/news/95/1673/biopharma-thrust-pays.html https://biospectrumindia.com/news/95/1673/biopharma-thrust-pays.html Tue, 10 Aug 2004 17:24:00 +0530 Rank 7...................Wockhardt Revenue: 84 crore Biopharma Thrust Pays CEO: Habil Khorakiwala Revenue: 84 crore Start-up year: Mid 1960's Business: Manufacturing and marketing of recombinant biopharmaceuticals Address: Wockhardt Towers, Bandra Kurla Complex, Bandra (East), Mumbai - 400 051 Tel: 91-22-26534444 Fax: 91-22-26534242 Website: www.wockhardt.com Established nearly four decades ago, Wockhardt today is a research and technology oriented pharmaceutical company in India. Since inception it is pursing health care with a passion reflected in its initiative and innovation in research, manufacturing, marketing and in its service to mankind. Wockhardt has an active multi-disciplinary R&D program involving over 350 scientists, largely focused on developing innovative technologies and drug discovery. The company has a team of over 90 scientists engaged in new drug discovery research and has several new chemical entities in the field of sepsis and anti-infectives. The company's efforts in biotechnology have led to three successful brands â€“ Biovac-B (hepatitis-B) vaccine, Wepox (erythropoietin) and Wosulin (rDNA human insulin). Wockhardt launched Wosulin, India's first recombinant human insulin developed indigenously in August 2003, making India the first Asian country to develop, manufacture and market the product. With this, it became the fourth company in the world to manufacture and market recombinant human insulin. Technological capabilities and strong commitment of a team of scientists have kept Wockhardt in the forefront of the emerging fields of biotechnology and pharmaceuticals. Wockhardt with its three successful biotechnology products in the market has received marketing registrations for bio pharmaceuticals in three countries. The new drug discovery program at Wockhardt has promising lead molecules in its pipeline in addition to WCK â€“771, which will soon undergo phase II clinical trials. This will be useful in treating Methicillin and Vancomycin resistant, life threatening infections and sepsis. Another chemical entity WCK â€“1457 shows potent activity against enterococci and is undergoing toxicity studies. Wockhardt has also filed investigational new drug (IND) application for WCK-1152 for treating hospital and community acquired respiratory tract infection that has completed pre-clinical trials. A promising new biopharmaceutical for Wockhardt, Interferon alfa 2b, is undergoing phase III clinical trials. The project to manufacture monoclonal antibodies is also shaping up well at its lab. Wockhardt has increased its R&D investments to 7.9 percent of the total sales in 2003 from previous year's investment of 6.2 percent. So far it has invested Rs 360 crore in the multidisciplinary research programs in the recent years including the setting up of a world-class research and development center at Aurangabad with an investment of Rs 150 crore. The University of Pune has accorded recognition to Wockhardt Research Centre, Aurangabad, as a Post Graduate Research Center for undertaking PhD programs in basic science and pharmaceutical science faculties of the university. Wockhardt has augmented its biotech revenue for the year ending December 2003. Of total annual sales of Rs 980 crore, the biotech revenue is about 8.5 percent, which equals to Rs 84 crore. The biotech sales will increase this year as Wockhardt has entered the global market for its recombinant biopharmaceuticals in the first quarter of 2004. Last year its revenue from biotech division stood at Rs 74 crore. ]]> <![CDATA[Poultry Saver]]> https://biospectrumindia.com/news/95/1661/poultry-saver.html https://biospectrumindia.com/news/95/1661/poultry-saver.html Tue, 10 Aug 2004 17:23:00 +0530 Rank 6...................Venkateshwara Hatcheries Revenue: 88 crore Poultry Saver CEO: Anuradha Desai Revenue: 88 crore Start-up year: 1971 Business: Engaged in research, development, production and export of poultry vaccines and diagnostics Address: Ventri Biologicals, 17/6, Milestone, Pune Panshet Road, Post Office Girinagar, Pune 411 - 025 Tel.: +91-20-24389471, 24389474 Fax: +91-20-24389471 Website: www.venkys.com Venkateshwara Hatcheries (VH) Private Limited, a flagship company of the VH Group was founded in 1971 by Dr BV Rao. It was the first Indian company to embark on a process of developing the poultry industry on scientific lines. It pioneered the concept of parent franchisee operations, popularized cage farming, and introduced the concept of inactivated vaccines and combination vaccines, and more importantly, use of specific pathogen free (SPF) eggs in vaccine production. The SPF eggs form a vital ingredient in the manufacture of poultry vaccines of international standards. The VH Group is the largest fully integrated poultry group in Asia by offering total support for poultry development under one roof. The Group has diverse stakes in breeding of poultry, poultry equipment, hatcheries, egg and chicken processing, animal health products, production of SPF eggs and poultry feed. Besides poultry vaccines and medicines, the group produces a range of feed additives, animal health products and poultry feeds. The VH group has eight zonal laboratories located in regional poultry pockets, which provide disease-monitoring and diagnostic services free to all farmers irrespective of the breed they patronize. Ventri Biologicals, the vaccine division of the Venkateshwara Hatcheries, was set up in late 1970's when the Indian poultry industry was facing severe challenges due to unavailability of quality vaccines for several disease conditions. The division became operational in 1980, with the production of vaccines for Marek's disease and Newcastles's disease. The plant was built in collaboration with Tri Bio Laboratories Inc. of the US, world leaders in vaccine technology and research. It is also among the few laboratories of the world, which produces Marek's HVT vaccine on a large scale. The vaccine plant is acknowledged as one of the most modern plants and is capable of meeting the demands of the projected growth of the Indian poultry industry. Backed by extensive, modern research and development facilities, Ventri Biologicals in close association with the Poultry Diagnostic and Research Center is engaged in the development of new generation vaccines to combat emerging bacterial and viral diseases. The division produces vaccines conforming to British Pharmacopeia and other international standards. It produces live and inactivated viral vaccines using complex cell culture and egg adapted technology with highly immunogenic vaccine virus strains in sterile atmosphere, using Specific Pathogen Free (SPF) eggs. For bacterial inactivated vaccines it has adopted the advanced programmed biofermentation technology. Ventri Biologicals provides a wide range of 32 poultry vaccines, some of which have been introduced for the first time in the country. The biotech business of Venkateshwara Hatcheries, including vaccines and diagnostics, notched up sales of Rs 88 crore in 2003-04. ]]> <![CDATA[Insulating the World Against Diabetes]]> https://biospectrumindia.com/news/95/1980/insulating-the-world-against-diabetes.html https://biospectrumindia.com/news/95/1980/insulating-the-world-against-diabetes.html Tue, 10 Aug 2004 17:22:00 +0530 Rank 5...................Novo Nordisk India Revenue: 110 crore Banking on Multiple CEO: Anil Kapur Revenue: 110 crore Start-up year: 1994 Business: Biopharmaceuticals Address: 8th Floor, Raheja Towers, 26/27- M.G Road, Bangalore - 560 001 Tel: 91-80-25327447 Fax: 91-80-25594409 Website: www.novonordisk.co.in Novo Nordisk is the leader of diabetes care in India. It was set up first as the Danish-major Novo Nordiskin A/S representative office in Mumbai in 1990 with Dr Anil Kapur as the head. Till then, its products were marketed in India by various other companies. On April 1st, 1994 Novo Nordisk (I) Pvt. Ltd. was set up with its headquarters in Bangalore with 26 employees. It has now been rechristened as Novo Nordisk India Pvt Limited. Since then the company has grown in stature. Now as an established healthcare company in India, Novo Nordisk markets products in three therapeutic areas-Diabetes care, Growth disorders and Women health. Novo Nordisk India has launched the first country specific diabetes care informative website- www.novoindia.com. In 2003-04, its sales from biotechnology products has been estimated at Rs 110 crore. During the same period it has added 200 employees to the rolls. Novo Nordisk also holds the leading position in areas such as haemostasis management, growth hormone therapy and hormone replacement therapy. It manufactures and markets pharmaceutical products and services. The company is headquartered in Bagsvaerd, Denmark. The company relies on biotechnology in the development of it successful products. These are human insulin, insulin aspart, insulin detemir, growth hormone, FVIIa and glucagon. The company's ability to master protein expression in bacteria, yeast and mammalian cells is complemented by similar cutting edge capabilities within protein drug delivery. The above three sets of competences-research into diabetes, proteins and their delivery form the basis for R&D strategy which aims at providing diabetes care leadership. The company has a strong product pipeline. Among them, Levemir (insulin detemir) is almost ready to hit the market. This insulin detemir is for Type 1 and 2 diabetes and it is submitted for registration in the US market but it has already received an approvable letter obtained from the US health care authorities. However, it is been approved in EU and Switzerland. And it is in Phase 3 in Japan. For the Indian market, the company is offering injectable devices for diabetes cure. These are, NovoPen 3, NovoLet and NovoFine. In order to understand the needs of its Indian customers better in each geographical area-North, East, West and South, the company has established regional offices in New Delhi, Kolkata, Mumbai and Chennai respectively. ]]> <![CDATA[Banking on Multiple]]> https://biospectrumindia.com/news/95/1048/banking-on-multiple.html https://biospectrumindia.com/news/95/1048/banking-on-multiple.html Tue, 10 Aug 2004 17:21:00 +0530 Rank 4...................Nicholas Piramal India Revenue: 130 crore Banking on Multiple CEO: Ajay Piramal Revenue: 130 crore Start-up year: 1988 Business: Biopharmaceuticals and diagnostics Address: 100, Centre Point, Dr Ambedkar Road, Parel, Mumbai - 400 012 Tel:91-22-56636666/56636441 Fax: 91-22-24172851 Website: www.nicholaspiramal.com Vital Stats: YEAR Revenue (Rs crore) 2003-04 130.00 2002-03 70.64 Nicholas Piramal India Limited (NPIL), a large pharmaceutical healthcare company, has a strong presence in antibiotics and respiratory segments, pain management, neuro-psychiatry and anti-diabetics segments. NPIL has commenced its research activities in biotechnology. But it has not made any break through in its research activities focused on four key areas namely, new drug discovery, genomics, clinical and naturals research. It has appointed two scientists of international repute, Prof Bob Chaudhari and Dr Ravinder Maini as its scientific advisors. NPIL has entered into a joint venture with New Delhi based Institute of Genomics and Integrative Biology which is into functional genomics and signed an agreement with the Center of Biotechnology (CBT) at Anna University in Chennai for exclusive R&D collaboration in the areas of cancer and inflammation. It has also entered into "research collaboration" with the Indian Institute of Science, Bangalore to identify potential new targets for developing drugs to treat fungal infections. NPIL will have exclusive rights to commercialize any product coming out of the collaborative efforts. NPIL has embarked on a focused R&D program in the areas of new chemical entity (NCE), new drug discovery system (NDDS), and process development. It is investing 4-5 percent of its total revenue into R&D activities. The company is setting up an R&D center in Mumbai, which can accommodate about 400 scientists. Already one third of the work has been completed. NPIL has made an initial investment of Rs 10 crore and is planning to invest another Rs 65 crore in this project. The R&D division currently employs 255 people and is engaged in a number of long-term exploratory and basic research programs in chemistry, biology and natural product chemistry dedicated to product development. Besides it is also looking at strategic R&D alliances in four specific areas namely vaccines, functional genomics, cancer research and arthritis. NPIL has already filed its first patent on NCE, an anticancer molecule NP102, in India and the US. Majority of its pipeline consists of drugs in the pre clinical stage with the most advanced candidate being for the treatment of cancer. It is expected that it will complete the necessary toxicology studies in the second half of 2005 and enter phase I/II clinical trials by the end of the year. Although its revenue from the biotech division has dropped due to the termination of its agreement with F Hoffman-La Roche in November 2003, but picked up as it entered into strategic alliance with Biogen Idec, the world's third largest biotech company to market Avonex (Interferon beta 1a) a leading life-saving therapy for multiple sclerosis in India and Nepal. During the year it has also acquired a few brands of Sarabhai Piramal. The sales of its diagnostic business continued to drive growth through the greater emphasis on reagents sales than instruments, customer relationship management and high quality services. Its net sales of diagnostic division increased to Rs 77 crore in financial year 2004 compared with Rs 66.35 crore in FY 2003 representing a growth of 17 percent. And its revenue from biotech division for the year FY 2004 stood at Rs 50.8 crore against last year's revenue of Rs 65.06 crore. ]]> <![CDATA[Polio Killer]]> https://biospectrumindia.com/news/95/1854/polio-killer.html https://biospectrumindia.com/news/95/1854/polio-killer.html Tue, 10 Aug 2004 17:20:00 +0530 Rank 3...................Panacea Biotec Ltd Revenue: 149.53 crore Polio Killer CEO: Soshil Kumar Jain Revenue: 149.53 crore Start-up year: 1984 Business: Healthcare Company Address: B-1 Etxn./A-27, Mohan cooperative Industrial Estate, Mathura Road, New Delhi- 110044 Tel: +91-11-26945270 Fax:+ 91-11-26940199 Website: www.panaceabiotec.com Vital Stats: YEAR Revenue (Rs crore) 2003-04 149.53 2002-03 169.23 I n recent years, Delhi-based Panacea Biotec has emerged as a leading health care company of India. It manufactures and markets vaccines, branded formulations and biotechnology-based products of international quality. The manufacturing plant of Oral Polio Vaccines (OPV) in New Delhi has been awarded the WHO-GMP certification. The company meets most of the state requirements of OPV under Pulse Polio Program in India. The plant for manufacturing formulations was commissioned in 1989 in New Delhi. From trading of pharmaceutical products to manufacturing, Panacea Biotec (earlier known as Panacea Drugs Pvt. Ltd.) offers a range of products. The roots of Panacea Biotec can be traced to a small medicine shop in Sialkot (now in Pakistan) in 1927. The big thrust came in 1993, with a focus on biological and biotechnology-based products, in addition to formulations. The year 1995 saw the merger of its vaccines and pharmaceutical operations into one unit named Panacea Biotec. In the same year the company forayed into pain management and diabetic management segments by introducing the unique non-steroidal anti-inflammatory drug-Nimulid (Nimesulide) and Glizid (Gliclazide). These brands have become leaders in their market segment. In 2001, the company visualized its long-term strategies, venturing into new opportunities available in the horizon, namely, health and disease management. With a special focus on biotechnology, Panacea Biotec has been making concerted efforts to improve the repertoire of its vaccines. A host of new vaccines employing genetic engineering and recombinant technology are being developed. The Hepatitis B vaccine, Enivac HB, is being manufactured in collaboration with CIGB (Center for Genetic Engineering and Biotechnology), Havana, Cuba-a world leader in biotechnology. Amongst the forthcoming vaccines is an Anthrax vaccine. Its vaccine and formulation plants are approved under WHO-GMP certification. Panacea Biotec is among those few health companies of Indian origin, which have strategically initiated themselves to take up new challenges in the post WTO era. Major initiative from Panacea's side in this direction is the setting up of its own R& D center at Lalru near Chandigarh in North India. It is built on a 20,000 sq. feet area, equipped with quality infrastructure and other high-end facilities. A team of 60 scientists work at R&D center, which has earned the recognition of Ministry of Science and Technology, Govt. of India. Panacea has registered a turnover of Rs 149.53 crore from the biopharmaceuticals business in 2003-04. However, the company is expecting better results after the end of current fiscal year. The company has more than 2000 employees on its rolls. Out of this, around 1000 are field sales personnel who promote the products of its three divisions- Primary Care, Secondary Care and Critical Care to the medical profession. ]]> <![CDATA[Biotech Trend Setter]]> https://biospectrumindia.com/news/95/5785/biotech-trend-setter.html https://biospectrumindia.com/news/95/5785/biotech-trend-setter.html Tue, 10 Aug 2004 17:16:00 +0530 Rank 1...................Biocon Biotech Income: 502.52 crore Biotech Trend Setter CEO: Kiran Mazumdar-Shaw Biotech Income: 502.52 crore Start-up year: 1978 Business: Biopharmaceuticals and industrial enzymes Address: 20th KM Hosur Road, Electronic City, Bangalore â€“ 561 229 Tel.: +91-80- 28523430-34, Fax: +91-80- 28523423 Website: www.biocon.com Vital Stats: YEAR Turnover Investment (Rs crore) (Rs crore) 2003-04 502.52 384.65 2002-03 254.34 72 2001-02 161.6 75 YEAR Employees 2003-04 696 2002-03 538 2001-02 469 It has been an outstanding year for Biocon. First, it set a new trend in the biotech industry with its initial public offering(IPO). Its public issue opened on 11 March and closed on 18 March 2004. It was the time when there was a spate of IPOs. Yet, Biocon's IPO generated an overwhelming response and the total demand was in excess of Rs 10,000 crore. The overall issue was oversubscribed by about 32 times. But more importantly, over 90 percent of the demand came at the top end of price band, i.e., Rs 315 per share. Second, the company crossed the Rs 500 crore mark in terms of revenues. Biocon ended the fiscal at Rs 511.17 crore, almost double the size it was in the previous fiscal. The biotech income alone was Rs 502.52 crore. The company has evolved as an integrated biotech enterprise with focus on healthcare and enzymes, ingredients and process aids. The strong growth in 2003-04 has been led by statin sales. The total statin sales grew by over 152 percent from Rs 199.32 crore to Rs 302.84 crore. The statin sales accounted for 69 percent of its total sales. Its statins portfolio comprises Lovastatin, Simvastatin, Pravastatin, and Atorvastatin. During the year, it received a certificate of suitability for its Pravastatin and its manufacturing facility was US FDA approved. Its immunosuppressants grew by about 292 percent to post total sales of Rs 34.9 crore. While Mycophenolate mofetil has been sold mostly in the domestic market, Tacrolimus was launched in FY 2004. Along with the growth of the pharmaceuticals business, it continues to have a strong hold on its oldest business of enzymes. The total enzymes business grew from Rs 53.1 crore to Rs 66.5 crore, with the industrial enzymes business standing at Rs 18.07 crore. Pectinase was its largest enzyme product. The company's success has been characterized by a set of strong corporate values, management commitment and innovation. It has increased its investments in the manufacturing and research areas. In 2003-04 its investment on R&D alone was close to Rs 9 crore, accounting for about 1.75 percent of its total turnover. During the period its overall investment grew to Rs 384.65 crore. While the company's statin portfolio may be the biggest contributor, it has looked for a future beyond statins too. It has successfully developed its first recombinant human insulin at a commercial scale. Not just that, Biocon has entered into a 9-year supply agreement with Bristol-Myers Squibb, a global pharma giant and also filed a Drug Master File (DMF) for recombinant human insulin with US FDA. Further, it will also be launching its finished formulation, Insugen, in the domestic market as soon as it gets the final regulatory approvals. It has also entered the branded formulations in the cardio-diabetes segment. It recently inaugurated a central warehouse to distribute the products and a supply chain system too is in place. Also in the pipeline are streptokinase, erythropoeitin, interleukin IIb, human growth hormone and anti-cancer monoclonal anti-bodies. Biocon is already on a high growth path this fiscal. Revenues from the biopharmaceuticals business increased to Rs 178 crore in first quarter of FY 2005. ]]> <![CDATA[Global Trends]]> https://biospectrumindia.com/news/95/8092/global-trends.html https://biospectrumindia.com/news/95/8092/global-trends.html Tue, 10 Aug 2004 17:02:00 +0530 Any discussion of biotechnology industry development across Asia-Pacific cannot overlook the diversity of cultural traditions among the nations of this great region and the sheer market and intellectual power represented by the size of the population The nine countries discussed in "On the Threshold", the Global Biotechnology Report 2004 on Asia-Pacific account for 43 percent of the world's population; 37 percent of the planet's 6.3 billion people live in just two of these nations, China and India. The other seven are Australia, Japan, Malaysia, New Zealand, Singapore, Korea and Taiwan. The rapid economic growth in Asia-Pacific highlights the enormous potential purchasing power of the region, accelerating the pace of biotechnology industry development. Asia-Pacific biotechnology at a glance PublicCompany Data(in US $) 2003 2002 %Change Revenue 1,504.70 1,375 9 R&D Expense 216.7 196.6 10 Net Loss 170 112 52 Number of employees 9,810 9,760 1 Source: Ernst & Young The International Monetary Fund(IMF) shows China and India's economies growing by 7.5 percent and 5.9 percent respectively, in 2004, as measured by inflation adjusted growth of gross domestic product(GDP), compared to 3.9 percent for the US and 2 percent for the European Union. Much of Asia-Pacific's rapid growth has been fueled by technology-initially through manufacturing and recently in some countries through information technology (IT) services. Biotechnology now has the potential to replace IT as the engine of economic development for the 21st century. The recent success of Biocon India's public offering in early 2004 generated the sort of media attention showered on IT companies only a few years earlier, with much speculation that the company's founder and chairman, Kiran Mazumdar-Shaw had become India's wealthiest woman. While attention is often paid to the rapid economic growth in Asia-Pacific, less attention is given to the fact that some of these countries are already among the world's largest economies. Many economists argue that using "purchasing power parity" exchange rates is a better gauge of the relative size of different economies than official exchange rates. Using purchasing power parity exchange rates, China, Japan and India rank second, third and fourth, respectively, after the US in terms of GDP. When Ernst & Young first expanded its US, European, Canadian and Australian biotechnology reports to include other major biotech centers in Asia-Pacific in 2002, it applied a uniform definition of biotechnology companies to collect data on the industry in an effort to make comparisons across all regions. Asia-Pacific biotechnology at a glance Number of Companies 2003 2002 %Change Publiccompanies 120 108 11 Privatecompanies 547 493 11 Public and private companies 667 601 11 Source: Ernst & Young The definition is based on the entrepreneurial, independent biotech business model that gave rise to the industry in the West-from start-ups such as Amgen, Biogen, Chiron, Genentech and Genzyme. These companies launched the global biotechnology revolution. They were founded in the late 1970s and early 1980s in the US to apply recombinant DNA technology to manufacturing vaccines for infectious diseases, such as hepatitis B and protein therapeutics, such as insulin for diabetes. Since then, the global industry has grown to nearly 4,500 companies that are discovering unique, gene-based medicines for illnesses that previously were considered untreatable. The Ernst & Young definition of biotechnology also includes entrepreneurial companies that apply biotechnology to developing innovative products for agriculture, environment management, and industrial manufacturing. In some Asia-Pacific nations, the impact of biotechnology in agriculture is as great as in health care. Unlike the West, much of the biotechnology activity conducted by publicly traded companies in Asia-Pacific is within conglomerates , particularly in Japan and Korea. Consequently, the financial performance indicators Ernst & Young quotes for Asia-Pacific publicly traded companies are estimates of the research-driven biotechnology activities conducted by the conglomerates, factoring out non-biotech activities. In addition, a significant share of the Asia-Pacific industry includes contract research and manufacturing activities that are outside the scope of Ernst & Young's definition of biotechnology companies. Some differences between Western regional biotech industries and the Asia-Pacific industry are reflected in the financial indicators. For examples, the R& D expenses are significantly lower in Asia-Pacific than in other regions. Estimated R & D expenses of the Asia-Pacific industry are about 14 percent of estimated revenues, compared with more than 35 percent in the US, Europe and Canada. These differences also make estimation of the Asia-Pacific industry's financial performance challenging. While Ernst & Young Asia-Pacific data show an aggregate net loss for the industry in the region, many Asia-Pacific publicly traded companies report considerably higher levels of profitability, reflecting that much of the financial gain experienced by these companies falls outside of their core biotechnology activities. The financial data for 2003 show that Asia-Pacific publicly traded companies account for about 3 percent of global revenues compared with 77 percent for the US, 16 percent for Europe and 4 percent for Canada. The US recorded the most significant gain in share of revenues, a 5 percent increase from 72 percent in 2002. The US dominates the global biotechnology industry and has led the industry's 2003-04 recovery following two years of depressed stock market values worldwide. Asia-Pacific, however, outperformed Europe, whose biotech industry registered drops in revenues, R&D expenses, number of companies and number of employees in 2003 compared with 2002. Asia-Pacific company revenues increased by 9 percent in 2003 over 2002, R&D expensed jumped 10 percent and the number of companies surged 11 percent. Australia leads the Asia-Pacific region in number of public and private companies with 226. China, including Hong Kong, is second with 136, and India, Taiwan and Korea round out the top five with 96,52 and 41 respectively. Australia is sixth in the world in number of biotech companies. China and Hong Kong are tenth and India is 11th. The US is first , followed by Canada, Germany, the UK, and France to complete the Top Five. Australia's biotech industry in 2003 experienced increase in revenues, R&D expenses and number of companies. The industry's total market capitalization also surge 21 percent or nearly $ 1 billion over 2002. Ranking of Asia-Pacific countries in terms of number of companies 1 Australia 226 2 Hong Kong and ChinaPull/Pulk Revolving Doors 136 3 India 96 4 Taiwan 52 5 Korea 41 6 Japan 40 7 New Zealand 28 8 Singapore 27 9 Malaysia 18 10 Philippines 9 11 Thailand 8 The biotechnology profile of Asia-Pacific, in which Australia is most prominent, is likely to change over the next few years. Japan's biotech industry is growing rapidly through the support of government funding and domestic investors. Investors, in the past several years, have been more aggressive in breaking with tradition to support start-up companies that record deficits instead of profits. In addition, Japan's university system has undergone recent changes that encourage scientists to form companies. The Chinese biotech industry also is growing, fueled by demands for improved health and quality of life by the world's largest domestic market-1.3 billion people. The Chinese industry has evolved from companies that were formed in the late '1980s and early 1990s to manufacture therapeutic proteins developed in the West. The new generation of Chinese companies are also copying the West, but this time it is the Western business model for creating unique, patent-protected medicines that command higher profit margins than the biogenerics or biosimilar drugs. The Chinese biotech companies of the 21st century are receiving considerable support from the government in funding in recognition of the significant of intellectual property protections. The infrastructure for the Indian biotech industry, like that in China, was established to manufacture the therapeutic proteins developed in the West. Both Indian and China are positioned to take advantage of moves by governments in the US and Europe to create a regulatory framework for approving generic versions of successful protein drugs, such as erythropoietin, whose patent exclusivity is expiring. In 2003, sales of various patented versions of the anemia drug totaled more than $ 9 billion. While the US and European biotech industries and their regulators debate whether the manufacturing of safe and effective biologics can be copied, companies in India and China have been doing it for years and are ready to enter Western markets with their likely lower-cost versions of these medicines. In addition, Singapore, India, China, and Taiwan are promoting business advantages, such as reduced labor costs, to Western companies, in efforts to become the nations of choice for outsourcing R&D, clinical testing and manufacturing of biologics and pharmaceuticals. The Ernst & Young report, On the Threshold has examined in detail the evolution of biotechnology in Asia-Pacific. What emerges is a portrait of a region whose biotech engine is revving loudly, fueled by aggressive government funding, that likely will drive many nations over the next decade to surpass competitors in Europe and begin to challenge the US for global dominance in production of biotechnology products. Courtesy: Ernst&Young. Extracted from "On The Threshold: The Asia Pacific Perspective in the Global Biotechnology Report 2004." The full report is available with Ernst & Young. ]]> <![CDATA[Regulating GMOs]]> https://biospectrumindia.com/news/95/3009/regulating-gmos.html https://biospectrumindia.com/news/95/3009/regulating-gmos.html Tue, 10 Aug 2004 17:01:00 +0530 COLUMN Prof. MS Swaminathan Regulating GMOs There is an urgent need to set up a transparent regulatory mechanism to handle Genetically Modified Organisms (GMOs), which inspires public, political and professional confidence, according to Prof. MS Swaminathan, one of the world's leading agricultural scientist. Prof. Swaminathan has just submitted the report of the National Task Force chaired by him on Using Biotechnology in Agriculture. The elucidation of the double-helix structure of the Deoxy ribose Nucleic Acid (DNA) molecule in 1953 by Drs. James Watson, Francis Crick, Maurice William and Franklin Rosalind marked the beginning of what is now known as the new genetics. Research during the last 51 years in the fields of molecular genetics and recombinant DNA technology has opened up new opportunities in agriculture, medicine, industry and environment protection. The ability to move genes across sexual barriers has led to heightened interest in the conservation and sustainable and equitable use of biodiversity, since biodiversity is the feedstock for plant, animal and microbial breeding enterprises. Considerable advances have been made during the last 25 years in taking advantage of the new genetics in the areas of medical research, production of vaccines, sero-diagnostics and pharmaceuticals for human and farm animal health care. The production of novel bioremediation agents as for example, the development of a new Pseudomonas strain for clearing oil spills in oceans, rivers and lakes by Dr. Anand Chakraborty, is also receiving priority attention because of increasing environmental and water pollution. There has also been substantial progress in agriculture, particularly in the area of crop improvement through the use of molecular marker assisted breeding, functional genomics, and recombinant DNA technology. A wide range of crop varieties containing novel genetic combinations are now being cultivated in USA, Canada, China, Argentina and several other countries. A strain of cotton containing the Bacillus thuringiensis gene (Bt cotton), which has resistance to boll worms, is now under cultivation in India based on both official and unofficial (illegal) releases. There is little doubt that the new genetics has opened up uncommon opportunities for enhancing the productivity, profitability, sustainability and stability of major cropping systems. It has also created scope for developing crop varieties tolerant/resistant to biotic and abiotic stresses through an appropriate blend of Mendelian and molecular breeding techniques. It has led to the possibility of undertaking anticipatory breeding to meet potential changes in temperature, precipitation and sea level as a result of global warming. There are new opportunities for fostering pre-breeding and farmer-participatory breeding methods in order to continue the merits of genetic efficiency with genetic diversity. While the benefits are clear, there are also many risks when we enter the territory of the unknown and unexplored. Such risks relate to potential harm to the environment and to human and animal health. There are also equity and ownership issues in relation to biotechnological processes and products. The following issues are the major areas of concern to the public and policy maker. a. What is inherently wrong with the technology? Is the science itself safe, as for example, the use of selectable marker genes conferring antibiotic or herbicide resistance? b. Who controls the technology? Will it be largely in the private sector? If the technology is largely in the hands of the private sector, the overriding motive behind the choice of research problems will be private profit and not necessarily public good. If this happens, "orphans will remain orphans" with reference to choice of research priorities. Crops being cultivated in rainfed, marginal and fragile environments, which are crying for scientific attention, may continue to remain neglected. c. Who will have access to the products of biotechnology? If the products arising from recombinant DNA technology are all covered by intellectual property rights (IPR), then the technology will result in social exclusion and will lead to a further enlargement of the rich-poor divide in villages. d. What are the major biosafety issues? There are serious concerns about the short and long term impact of GMOs (genetically modified organisms) on the environment, biodiversity and human and animal health. Thus, there is need for transparent and truthful risk-benefit analysis in relation to GMOs, on a case-by-case basis. In the coming decades, Indian farm women and men will have to produce more food and other agricultural commodities to meet home needs and to take advantage of export opportunities, under conditions of diminishing per capita availability of arable land and irrigation water and expanding abiotic and biotic stresses. The enlargement of the gene pool with which breeders work will be necessary to meet these challenges. Recombinant DNA technology provides breeders with a powerful tool for enlarging the genetic base of crop varieties and to pyramid genes for a wide range of economically important traits. The safe and responsible use of biotechnology will enlarge our capacity to meet the challenges ahead, including those caused by climate change. At the international level, the Cartagena Protocol on Biosafety provides a framework for risk assessment and aversion. At the national level, there is need for a regulatory mechanism, which inspires public, political and professional confidence. The Union Ministry of Agriculture set up in May 2003, a Task Force to consider the above issues and offer suggestions on how Indian farm women and men can derive benefit from the new genetics, without taking unacceptable environmental, health and social risks. The Task Force felt that the process of preparing recommendations is as important as the product. Hence, multi-stakeholder consultations were held, including with mass media representatives. Agriculture is a state subject in our country and hence considerable importance was attached to hearing and receiving the views and suggestions of State Governments. Agriculture comprising crop and animal husbandry, fisheries, forestry and agro-processing constitutes the backbone of our food, livelihood and ecological security systems. In addition, it is fundamental to national sovereignty and to fighting the famine of jobs. Hence, it will be no exaggeration to say that "if agriculture goes wrong, nothing else will have a chance to go right". The Task Force therefore felt that the bottom line for any biotechnology regulatory policy should be the safety of the environment, the well being of farming families, the ecological and economic sustainability of farming systems, the health and nutrition security of consumers, safeguarding of home and external trade, and the biosecurity of our nation. Consumers all over the world are concerned with potential health risks associated with GM foods. The nature and extent of concerns vary from country to country, depending upon the confidence the public have in the food and environmental safety regulation systems in place. For example, the Food and Drug Administration (FDA) of the United States attracts greater consumer confidence than the counterpart systems in Europe. The situation in India is similar to that in Europe. Public regard and satisfaction for the regulatory systems currently in place in the field of agricultural biotechnology are, to say the least, low. In contrast to GM crops, 'life-saving' and 'life-enhancing' GM pharmaceutical products seem to have more ready acceptance. The socio-ethical perspective often defines the public risk perceptions. Bio-ethical norms are as important as biosafety regulations in the case of medical and pharmaceutical biotechnology. The ethical, social, gender equity and economic concerns will have to be considered along with the environmental and health safety aspects. To perform all these tasks in an objective, transparent and trustworthy mode, there is an urgent need for an autonomous, statutory and professionally led National Biotechnology Regulatory Authority. Such an Authority should be headed by an eminent expert well versed in the science of risk assessment and management, as well as risk communication. The members of such a Biotechnology Regulatory Authority of India should be leading authorities in the areas of environment protection, human and animal health, ethics, gender and social equity and trade and international protocols. The National Biotechnology Regulatory Authority could have a common Chair but two separate wings â€“ one dealing with food and agricultural biotechnology, and the other with medical and pharmaceutical biotechnology. The mandate of our Task Force was confined to agricultural biotechnology and hence our recommendations relate only to the field of crop and animal husbandry, forestry and fisheries. The setting up an autonomous, statutory and professionally-led National Biotechnology Regulatory Authority is a must for our country if we are to derive full benefit from this fast growing area of science, including fields like functional genomics, proteomics, bio-informatics and nano-biotechnology, in a safe and responsible manner. Pending the establishment of a National Biotechnology Authority, with a specialized wing for Agricultural Biotechnology, the Task Force has offered suggestions for streamlining and improving the regulatory procedures now in force. These suggestions may be given effect to immediately, so that the on-going regulatory work continues without interruption. As mentioned earlier, agriculture is a state subject and new crop varieties are released regularly by the State Variety Release Committees. Therefore, there should be counter-part bodies in all the States and Union Territories to liaise with the proposed National Biotechnology Regulatory Authority. Progress in understanding the scientific and environmental issues relating to the safe and responsible use of biotechnology is extremely rapid. Therefore, the regulatory principles and procedures will have to be reviewed periodically by the proposed National Biotechnology Regulatory Authority so that they are based on advances in scientific knowledge. ]]> <![CDATA[Bt Cotton is a Winner]]> https://biospectrumindia.com/news/95/2114/bt-cotton-is-a-winner.html https://biospectrumindia.com/news/95/2114/bt-cotton-is-a-winner.html Tue, 10 Aug 2004 17:00:00 +0530 COLUMN Dr Shanthu Shantharam Bt Cotton is a Winner Bt (Bacillus thuringiensis) cotton MECH-162 in India seems to be a hands down winner according to a peer reviewed scientific paper by Bambawale et al in the June 2004 issue of Current Science (Vol. 86: No12; 1628-1633). This research report must be the first independently conducted study by Indian agricultural scientists on the performance of Bt cotton. It ought to put an end to any more debate on whether Bt cotton works or not; whether is it beneficial to farmers or not; or whether it yields better or not. Bambawale et al conducted a participatory field trial with MECH-162 variety of Bt cotton in Nanded district of Maharashtra spread over 33 hectares of irrigated area under the integrated pest management (IPM) conditions. Compared to other conventional cottons and non-Bt MECH cotton, MECH-162 did exceedingly well in every aspect of its agronomic performance. MECH-162 suffered significantly lower bollworm and sucking pest infestation, took four sprays less of insecticide and yield increased up to 12.4 quintals per hectare and a net return of Rs 16,231 per hectare in spite of the initial cost of the seed being higher. The quality of field data and the rigor of the analysis in the paper speak for itself and there should not be any more doubts about it. If people still do not believe that Bt cotton is a superior variety, then it is best to just ignore them and let the technology march on as it will and should.The results of Bambawale et al should not surprise any of us who have critically and objectively evaluated its performance in China, the US and South Africa. Bambawale et al findings readily support AC Nielsen. ORG-MARG study has reported that Bt cotton is a real winner. The fact that Bt cotton planting acreage today stands at almost 900,000 acres is a testimony of its superior performance. It seems that Gujarat is growing 100 percent Bt cotton for the past year. Almost 18 Indian seed companies have now sub-licensed the same Bt cotton technology from Monsanto. Two big bio agri companies Nuziveedu Seeds and Rasi Seeds have been authorized by the regulator, the Genetic Engineering Approval Committee (GEAC) to sell their Bt cotton varieties from next year. The competition is hotting up, as it should. Competition will no doubt bring down the price of Bt cotton, a natural market phenomenon. It is believed that these newly authorized Bt cotton varieties will give a run to Monsanto's MECH varieties because of their superior genetic background. The new varieties will be a boon for the cotton farmers with more choice of seed varieties. One need to ask to why the Bt cotton acreage is increasing year after year in India and why more and more seed companies are buying license to get the Bt cotton technology. The reasons are not too far to fetch. They all have seen on the ground how Bt cotton works and how the growers are happy to pay for this new technology and they do not want to miss the opportunity to benefit from it. I have no doubt those activist groups who have no love for GM (genetically modified) crops will once again criticize this good scientific paper by Bambawale et al as some ploy of the private sector. They will also try to discredit this GM technology. I suggest that anyone who is really interested in the truth of the matter, compare the data and reports put out by activists who are trying to discredit the GM crops technology and compare it with what AC Nielsen and Bambawale et al have published and determine for yourself as to which report is more authentic and scientific. If you do not have the expertise to judge it for yourself then take them to one who does and get a first hand opinion on them. The real good news is that newer and superior varieties of Bt cotton are coming to the market and that is proof positive that the technology works and it is beneficial. What is appealing in Bambawale et al paper was that the study was conducted with farmer's participation and under IPM conditions. This once again proves the point that Bt cotton technology can be managed efficiently under environmentally safe conditions. Verifiable and authentic results from elsewhere in the world clearly demonstrate that Bt cotton offers substantial and consistent benefits to the resource-poor farmers. The urban myth that GM crops do not benefit poor farmers in India and elsewhere is just that. Eventually farmers will decide what is good for them and decide they will. It is simply a matter of time and good technology will prevail and the rest fall by the way side. Hail to Bt cotton! (The author runs a bioagri consultancy, Biologistics International in Ellicott City, Maryland, USA. As the director of the US Department of Agriculture, Shantharam evaluated and cleared the world's first ever trial of Bt cotton and has since evolved the regulatory mechanisms to evaluate a variety of GM crops. He advises the governments in many countries on agricultural biotechnology) ]]> <![CDATA[Survival of the Fittest]]> https://biospectrumindia.com/news/95/2934/survival-of-the-fittest.html https://biospectrumindia.com/news/95/2934/survival-of-the-fittest.html Tue, 10 Aug 2004 16:59:00 +0530 COLUMN Nitin Deshmukh Survival of the Fittest If India is determined not to miss the next big industrial wave, biotechnology, it is imperative to evolve strong fiscal and regulatory policies that support entrepreneurship, low cost base for research and manufacturing and encourage investments into the sector, advises Nitin Deshmukh, Director-General, ABLE and Head (private equity), Kotak Mahindra Bank. Last year was exceptional for all sectors globally and in particular for Life Sciences. The industry showed many signs of evolving into a mature industry. Number of products, revenues, profits, market cap are all up and show intrinsic value. The industry was trumpeted as the "greenshoots" of investment and stock market recovery in Europe and the US as more biotech-derived products came to the market. Half of the new drugs approved by the US FDA in 2003 were biologics. The industry ended the year 2003 building a diverse portfolio of protein therapeutics, many of which achieved blockbuster status. Though there was a decline in the total number of biotech companies both in the US and Europe, those surviving appear to have a firm financial base with a more realistic product portfolio. The industry statistics for 2003 reflected healthy numbers. Market capital of US biotech industry increased from $ 219 billion in 2002 to $ 342 billion in 2003. US capital markets invested $ 16 billion in biotech in 2003 as against $ 10 billion in 2002. Life Sciences sector attracted 27 percent of all VC funding in 2003 in the US -the highest proportion in the last 12 years (NVCA survey) There were over 155 drugs in the market, 19 approved in 2003 and over 370 drugs were in various stages of clinical trials or awaiting FDA approval. What does this phenomenal performance mean for biotech in Asia and specifically India? The year 2003 witnessed many Asian countries encouraging biotech through government policy-making bodies providing significant funding support and fiscal incentives. Government support to infrastructure development is helping creation of biotech research and industry clusters. Asian countries have jumped on the biotech bandwagon in an attempt to differentiate and develop greater knowledge base in their economies and mitigating risk of overdependence on traditional commodity manufacturing and trading activities. Korea, Taiwan and Singapore have taken a leadership position followed closely by China and India. Unlike other sectors, Life Sciences rely on vast product and service revenue potential with a huge end user market. Asia with large unmet medical needs, unresolved diseases endemic to the region and demographics, presents such an opportunity to the Life Sciences industry. A generally benign regulatory environment, China's accession to WTO and compliance with TRIPS and India's adoption of product patents from 2005 can be expected to spur investments and cross border collaborations. While governments in Singapore, China, and Taiwan are vying with each other to lead in the area with large investments, India is yet to see a concentrated government effort, though the development of the biotech industry remains on its agenda. While the biotech industry in India grew at 40 percent during 2003-04, the country also witnessed the successful IPO of India's largest biotech company - Biocon which created excitement on two counts - creating a benchmark of Venture Capital (VC) success and sector valuation. While the success of Biocon brought into focus technoentrepreneurship and venture capital; scarcity of venture capital remained India's key challenge in developing the industry. With the exception of few VC's, most VC's in the country are fairly new to this sector, do not quite understand the issues, are averse to risk and gestation periods involved, unlike in the US and Europe where a deep VC industry has developed with many biotech sector focused funds. Countries that have shown leadership in biotechnology have seen their governments commit substantial public funds. The US, Canada, UK, Germany, Ireland, Australia and Israel government have invested billions of dollars to support emerging biotechnology developments, often in partnership with the private sector. Closer home, Japanese, Korean, Taiwanese and Singaporean governments actively promote and provide seed capital for biotechnology start up companies. Singapore has identified biomedical services as the next driver in its economic growth plan and has invested over S$ 2 billion into creating a world-class infrastructure and establishing the regulatory framework. In addition to providing direct seed funding and fiscal incentives, it is encouraging foreign scientists to join its government research programs in an attempt to create critical mass in its talent pool as also enable research collaborations. Scientists are being provided incentives to participate in upsides of their product commercialization. While it is too early to comment on the outcome of such initiatives, the country is certainly attracting enough attention to becoming the region's biotech hub. ]]> <![CDATA[Global Innovators]]> https://biospectrumindia.com/news/95/5223/global-innovators.html https://biospectrumindia.com/news/95/5223/global-innovators.html Tue, 10 Aug 2004 16:57:00 +0530 COLUMN RA Mashelker Global Innovators The world's leading technology companies are increasingly looking at ways to reduce their research budgets and ensure every dollar spent is stretched further and further. This opens up huge opportunities for providing research services to the world for many sectors including biotechnology, argues CSIR chief RA Mashelker. India is rapidly becoming a global R&D hub. More than 100 major companies around the world have set up their R&D centers in India in the last five years. The biggest would be the R&D center of General Electric (GE) in Bangalore. Its current size of 1,600 employees will increase to around 2,400 employees, making it the second largest R&D center of GE in the world. It is not India alone. Similar phenomena are in evidence in China, Korea, Singapore, Taiwan, etc. Specialized clusters are coming up in the Philippines, Malaysia, etc. Many leading enterprises around the world are building innovation platforms through multi-sourcing of innovations. Why has multi-sourcing of innovations gained prominence? There is an increasing pressure on shortening international market penetration times for new products, on shortening R&D times and on decreasing the market life times for new products. Innovations are beginning to have multiple geographical and organizational sources of technology with increasingly differentiated and innovation specific patterns of diffusion. R&D in high-technology industries such as biotechnology, microelectronics, pharmaceuticals, information technology and new materials has become highly science based. The costs of doing R&D are also increasing phenomenally. There has been a progressive weakening of the strategic position of corporate central laboratories within large firms. The firms around the world are becoming very selective with internal developments focused on critical products and processes. They complement their internal efforts with external technology acquisition on a global basis. Creation of seamless laboratories around the world is also being helped by the evolution of global information networks. Indeed, these networks are allowing the real-time management and operation of laboratories in any part of the world. Thus, companies are gaining a competitive advantage by using the global knowledge resource and working with a global time clock. The trend is also being fuelled by the shortage of R&D personnel in some emerging high technology areas in industrialized countries. The companies have to bridge that demand-supply gap in skills by external outsourcing. Obtaining access to high-quality scientists, engineers and designers is on the top of the agenda of many major companies now. The impact of the severity of the shortage of R&D personnel can be seen from this statistics from European Union (EU). For EU to meet the goal set at the Barcelona Summit to raise R&D spending as a share of GDP to 3 percent by 2010 will require 700,000 new researchers. Obviously, there will be a great demand-supply gap. It is not surprising that there will be a greater draw on "third world researchers" as one of the EU official put it recently. The demographic shift in the developed world means that developing countries with relatively favorable demographic profile with a large proportion of working and talented young people can become global innovation hubs, from which not only outsourcing of innovation will be done, but in which R&D based innovation centers will be set up by the companies from the developed world. This progressive shifting of the R&D location from the developed to the scientifically advanced developing nations is likely to have strong social, cultural, political, economic and strategic implications. Increased local demand on high quality science and scientists as also a competition between local institutions and industry on one hand and foreign R&D enterprises on the other hand for access to superior human capital will be some key drivers of change. Shifting of the "center of gravity" of knowledge production to these scientifically advanced developing nations will have strategic implications in the long run. Such shifts will also lead to a gradual reversal of brain drain due to the increased opportunities in the country of one's origin. ]]> <![CDATA[Pharma-Biotech Partnerships a Must]]> https://biospectrumindia.com/news/95/2277/pharma-biotech-partnerships-a-must.html https://biospectrumindia.com/news/95/2277/pharma-biotech-partnerships-a-must.html Tue, 10 Aug 2004 16:55:00 +0530 COLUMN Krishna M Ella Pharma-Biotech Partnerships a Must The time has come for the pharmaceutical and biotech industries to join hands to develop cutting edge biopharma products and add value to biogenerics to sustain India's edge in global markets, advises Krishna M Ella. Ella is the ABLE's head of the Special Interest Group on Biopharma and the Chairman of FICCI's Biotechnology Committee. In recent times, we have seen a lot of action on the regulatory front which impact the developments in biotechnology. The two most notable actions are the setting up of the National Task Force on Agricultural Biotechnology headed by Prof. MS Swaminathan and the Task Force on Recombinant Pharmaceutical Products chaired by Dr RA Mashelkar. I have no doubt that their recommendations will clear a lot hurdles facing some of the core sectors of biotechnology. There are other equally important areas that require immediate attention for the growth of the biotechnology sector in our country. The lack of availability of finance to help start ups in this sector has been another issue discussed widely. This is certainly becoming a big hurdle. In the absence of adequate finances, entrepreneurship is not taking place in a big way in the country. Biotechnology as a sector offers enormous opportunities to take up top quality research leading to the creation of intellectual property rights (IPR). What we need in our country is the emergence of a vibrant knowledge-based economy and to make this happen, availability of financial resources is a must. Instead what we are witnessing is the entry of the established players of the pharmaceutical sector into the biotechnology arena. There is nothing wrong with that. However, this does slow down the process of innovation. By and large, the established companies eschew innovation and stick to time tested methods, which just leads to incremental changes in the product portfolios. Just take the case of biogenerics. Our companies have invested huge financial and human resources into the development of biogenerics in the hope of capturing the price-sensitive markets for existing blockbuster drugs. This game has its limitations. The big pharma players have not been sitting idle. To protect their markets, these companies have built many barriers around their products. This has led to the development of "super biogenerics" supported by the owners of the original IPRs. The generics are becoming outdated. The "super biogenerics" have come in with new dosages, new formulations and with new processes. This has certainly helped to extend many existing patents. In such a scenario, survival will become an issue for the players in the biogenerics segment. Collectively, our industry should find a way out of this. There is a way. The bad situation can be turned around by adding value to the biogenerics, which will help to maintain their market share. How can this be done? We now have a large number of pure play biotech companies, which have invested heavily in recent years to develop cutting edge products. India's big pharma players should consider striking alliances wit these companies. It is a win-win situation for every one. The big pharma players will be able to tap the talents available in these biotech companies. The biotech companies will get the much-needed support from the established players. The bonus is of course, the vast marketing networks that the pharma companies have built up in the recent past. These pharma companies should consider outsourcing a lot of their development work to the biotech players and avoid duplication of investments and resources. After all, how many players do we need to manufacture, for example, erythropoietin? Such moves will help the pharma companies and also help the biotech startups to reach sustainable levels quickly. We have to look at the funding requirements from other angles too. The country requires a start-up fund to enable the PhD students in biotechnology turn entrepreneurs. Presently the venture capitalists are not interested in funding good ideas from our academics. We have to ensure that talented individuals with good business ideas are supported with soft funds, allowed to locate research facilities on their campus and helped to develop products to a stage, which will attract VC funds for commercialization. ]]> <![CDATA[Biotech Gathers Critical Mass]]> https://biospectrumindia.com/news/95/6097/biotech-gathers-critical-mass.html https://biospectrumindia.com/news/95/6097/biotech-gathers-critical-mass.html Tue, 10 Aug 2004 16:49:00 +0530 COLUMN Kiran Mazumdar-Shaw Biotech Gathers Critical Mass The Indian biotechnology industry is gathering momentum. With revenues of over $ 700 million (Rs 3,265 crore) in 2003-04, the fledgling biotech Industry, despite all the hurdles in its path is on the way to cross the psychological barrier of $ 1 billion in the current year. And if the momentum continues, the industry will reach its goal of $ 5 billion in 2010, comments Kiran Mazumdar-Shaw, CMD, Biocon and President, Association of Biotechnology-Led Enterprises (ABLE). The demise of Sir Francis Crick on 29th July 2004 calls for a final tribute to a man who discovered "The secret of life" along with James Watson in 1953. Five decades later, the promise of this discovery has led to new paradigms in the way we research new drugs, diagnose and manage diseases, meet global environmental challenges and address the nutritional and food needs of both the developed and developing worlds. Biotechnology is recognized the world over as the technology of the future. India has addressed this segment over the last decade by leveraging its low cost scientific skill base in an imitative manner with which to build its capabilities. Today, the Indian biotech sector has attained critical mass in manufacturing as well as research services and has slowly built a market for biotech products and services estimated at $ 700 million well on its way to reach its targeted $ 1 billion market size by 2005 and $ 5 billion by 2010. Indian Biotechnology is now poised to leverage its scientific skills and technical experience to make a global impact on a strong innovation led platform. Follow On Biologics The biotechnology sector is witnessing an impressive 40 percent annual growth realized through incremental revenues and the addition of new companies. India can today boast of being the world's largest producer of recombinant Hepatitis B vaccine thanks to the combined strength of Shantha Biotechnics, Bharat Biotech, Panacea Biotech, Wockhardt and Serum Institute. India is also emerging as a global player in recombinant Human Insulin where companies like Biocon and Wockhardt are the lead runners. Follow on Biologics like Streptokinase, GCSF, Interferon, EPO and others are all set to gain market share in the near future. Research Services Clinical services are now a global opportunity for India with a strong competitive edge based on speed and quality of clinical development. J.P. Garnier, CEO of GSK has recently announced that GSK will shift 30 percent of its clinical trials to countries like India and China in order to slash its clinical research budgets and stretch its current spending to more and larger trials. The CRO (contract research organization) segment is hence witnessing greater investment and is realizing faster growth than previously seen. CROs like Quintiles, Siro Clinpharm, Bharat Immunologicals, Clinigene, Lotus Labs, etc., are all enthusiastic of the bright prospects that lie ahead where India has a real potential to capture a significant slice of the global CRO pie. It is this potential that has prompted Covance, a US based CRO to sign a collaboration agreement with Siro Clinpharm in July 2003. Siro has reportedly conducted 20 Phase III trials since 1998 in head and neck cancer, tetanus and rheumatoid arthritis. Quintiles has conducted over 90 Phase II and III trials in India, including a trial for Eli Lilly for a combination drug, Symbyax (A combination of Zyprexa and Prozac) for the treatment of Bipolar depression, based on which, USFDA has given approval in December, 2003. Research services is another fast growing segment where companies like Syngene, Aurigene, Avesthagen and others have tapped into this global opportunity by offering to develop compound libraries, cGMPsynthesis of drug molecules for clinical evaluation, process development and process optimization and contract research projects. Recently, a German biotech firm, MWG has established its operations in Bangalore to develop Oligonucleotides for its Asia Pacific clients and later plans to offer its sequencing products and its hybridization services the world over. This model is expected to see other overseas biotech companies follow suit. Combining the strengths in clinical development with those of process development offers a powerful partnering opportunity for Indian biotech companies which can dramatically shrink time to market timelines as well as de-risk and augment valuations of International biotech companies. Diagnostics X-cyton, a Bangalore-based biotech company which has struggled to develop and market its novel HIV-HCV diagnostic kit is now well on the road to success and plans to launch PCR based diagnostic products for TB, Meningitis and Dengue Virus. Reametrix, a young Bangalore-based Start-up is also well on the road to be a provider of novel diagnostic products based on a proprietary quantum dot technology platform to International bioinstrumentation and diagnostic companies. Bioinformatics The two success stories of this segment are Strand Genomics and TCS ( Tata Consultancy Services). The latter recently launched Biosuite at BIO, San Francisco. Biosuite is a comprehensive software for computational biology that will compete with the likes of Accelrys and others. Strand Genomics has rolled out yet another proprietary product, Avadis, a powerful visualization bioinformatics tool and TruPK, ADME prediction software. Strand has successfully licensed Avadis to Abgenix and has signed up a co-distribution agreement with Japanese company, Kurabo. Agri Biotech Although little has happened after the approval of Bt cotton, the recently constituted M.S. Swaminathan Task Force promises to facilitate the regulatory process that is likely to see the roll out of a number of GM ( genetically modified) crops. Companies like Metahelix and Avesthagen continue to make progress on the research front. It is also important to highlight the importance that Bt cotton is gaining in the country being steered by Mahyco-Monsanto but closely followed by Nath Seeds, Ankur Seeds, Ajeet Seeds, Raasi Seeds, Krishi Dhan and Nuziveedu Seeds who are all at various stages of preparing to release their Bt cotton hybrids for commercialization by 2006. I would like to conclude on an optimistic note by drawing attention to India's rapidly growing strengths and capabilities in biotechnology which provides us with a new sense of confidence that Indian biotechnology can and will deliver a great economic growth sector of global standing in the foreseeable future. ]]> <![CDATA[Premium Awaits Bio IT Experts]]> https://biospectrumindia.com/news/95/1958/premium-awaits-bio-it-experts.html https://biospectrumindia.com/news/95/1958/premium-awaits-bio-it-experts.html Tue, 10 Aug 2004 16:28:00 +0530 COLUMN Dr Praveen Kini Premium Awaits Bio IT Experts Sky is the limit for professionals who combine the best of skills in computing and biology, emphasized Dr Praveen Kini, Head, Special Interest Group on Bio IT, Association of Biotechnology-Led Enterprises (ABLE). Kini is also the Chief Scientific Officer of CytoGenomics. Health and Bio IT are the two specialized segments of the IT industry that needs a very specific domain skill sets in addition to being an IT professional. These skills can be in the area of basic biology, medicine, medicinal chemistry and mathematics or computer science. The industry is looking out for persons with cross-domain skills and is willing to pay the premium prices for these segments. The question is do we need engineers with biology knowledge or biologists with engineering skills. The answer: we require both types of skills and we are willing to pay a premium for that. The next question is what kind of training both of them need? We look for a good record of skills from their primary domain (biology, medicine. engineering or basic sciences) and it should be supplemented with cross-domain skills applicable in their primary domain. For example a radiographer is a person who handles X-rays and CT scans for hospitals if he is able to understand and use specialized radiological software that is a valuable skill, the other example would be a lab scientist who can use the various software tools in the lab environment effectively. These examples still do not address the concerns of the beginner and what should they be doing to attract potential employer's attention. The attitude of learning-to learn for lifetime, is a skill that needs to be developed and maintained. Science is always growing and new branches of science keep appearing. In every decade there is a complete overhauling of knowledge repository and knowledge aging happens. In order to future proof, the candidates should develop the ability to learn new skills and knowledge in an accelerated fashion. This is akin to what happens in the movie Matrix, where new knowledge comes in a module, which you stick into your brain. In this case it means continuous training and knowledge gathering, identifying sources of data, use methodologies to quickly improve your basic knowledge. Resumes that will bring out that skill are picked up. Credentialing of statutory qualifications is important in this segment. Since in areas such as medicine most of the qualifications are statutory and if the work is being outsourced from the US, it becomes necessary to ensure the skills are credentialed by another US entity. Credentialed skills are at a premium, it could as simple as coding for medical records to as complex as US board certified physician. Till the supplies meet the demand there can be a significant premium to these skills. There are going to two kinds of jobs in this sector: 1. Production 2. Design Production The current known models in this segment are a. Curatorial services - This involves gathering information based on the person's domain knowledge in a specific subject. It may involve searching public or private databases. Arranging the data in an intelligent manner for easy retrieval and subsequent analysis. b. Production in health care can be analysis of patient records and images for either clinical trials, regular diagnostics or for research activities. These can be very demanding in terms of turn around time and regulations. c. Claims processing and other related activities. Here the knowledge of the health care administrative functions is vital. d. E-Submissions for drug trials and other related activities are emerging production areas. Design 1. In Silico Drug design 2. Software development 3. Bio-Medical engineering designing, MEMS, nanotechnology, etc. As the industry matures many of these emerging skill sets will get institutionalized and training centers will become available. As of now many of these skills have be obtained by self training as there are no formal ways to get them in the current scenario. Early movers are likely to get absorbed into the industry faster and may get a fast track to a better career. As in any science based industry there will always be areas of ignorance that smart people can exploit and move ahead. What is however more important is that there should be openness to imbibe new knowledge and skills. This should be a process and it should be continuously updated and improved upon. The future training will focus increasingly on Matrix like training modules which allow one to get the required knowledge and skill base in the most time and cost effective manner. Education focusing on these skills is bound to succeed in getting better personnel for the knowledge-based industry. ]]> <![CDATA[BioSuppliers Analysis]]> https://biospectrumindia.com/news/95/1874/biosuppliers-analysis.html https://biospectrumindia.com/news/95/1874/biosuppliers-analysis.html Tue, 10 Aug 2004 16:26:00 +0530 Agilent Technologies, Becton Dickinson, Thermo Electron, Millipore, Alfa Laval, Bio-Rad, Amersham (GE Healthcare Bioscience) and Sartorius have their direct presence. While others like Perkin-Elmer and Applied Biosystems have operations through agencies here. Lab India is an exclusive reseller of the products from these companies. In fact seven of the top 10 biotech suppliers are multinationals having their subsidiaries or joint venture companies located in India. They are Agilent, Becton Dickinson, Thermo Electron, Millipore, Alfa Laval and Sartorius. Amersham, now part of GE, too is present here. The company was unable to share the data, as there has been some internal restructuring following Amersham's acquisition by General Electric. One of the main reasons for the success of these world leaders in India is because of their commitment to the domestic market. Most of them have quality products, have started training centers, provide customized solutions and have been in the Indian market for several years now. In 2003-04, some of their worldwide CEOs and top executives too visited India and expressed their interest to set up testing and validation labs or announce expansions. It is not that all these companies have the same products, but their approach is almost the same. Due to these focused initiatives, major players have seen strong and consistent growth in line with that of the biotech sector. Agilent grew by about 55 percent, Becton by 66 percent, Thermo Electron by 51 percent, Lab India by about 25 percent, Millipore by about 21 percent, Alfa Laval by 100 percent, etc. Agilent, Becton Dickinson, Thermo Electron, Lab India and Millipore are the Top 5 companies in this industry and account for 78 percent of the total market share with total business of Rs 383.67 crore in 2003-04. While the estimated total business of the top 10 biotech suppliers was Rs 507.21 crore, the collective revenues of the top 20 biosuppliers was Rs 603.85 crore. These major suppliers have been investing significantly in the country both in terms of setting infrastructure and new marketing activities. In the past three years, they have invested close to Rs 1,500 crore. And this figure is on the rise. Most of the biosuppliers have established their manufacturing units in India and have nation-wide sales and support network. They have transformed from being product companies to solution-driven organizations. Customized solution is the mantra. The other important change that has come in the business approach is the need to be with the clients through their overall business strategy. This is to provide an effective solution. For most of the biosuppliers, the biotech and life sciences sector today accounts for major portion of their total business. It is approximately 40-45 percent of the total sales. A few years back, the demand for high quality products in separation, purification and membrane technology was very low. This is changing and the number of products and even suppliers are increasing rapidly. The products supplied to the biotechnology industry include bioreactors, biotech equipment, bioprocess plants, autoclaves, analytical instruments, separation plants, analyzers, centrifuges cleanroom technology, cleaning equipment, effluent treatment plants, filters, purified water, scientific doors, heat exchangers, etc. Company 2002-03(Rs Crore) 2003-04(Rs Crore) % growth Agilent 48 74.25 54.69 Becton Dickinson India 44.5 73.82 65.89 Thermo Electron 47 70.92 50.89 Lab India 54 67.5 25 Millipore India 47.15 57.18 21.27 Alfa Laval India 20 40 100 Bio-Rad Laboratories 33 38 15.15 Sartorius 19.09 30.99 62.34 Chemito Technologies 18.29 30 64.02 Genetix Biotech Asia 17.89 24.55 37.23 Chromline 18.4 20.7 12.5 Pall India 13 18 38.46 Imperial Biotech 5.65 10.2 80.53 Medispec 6 10 66.67 Axygen Scientific 4.9 7.02 43.27 Jain Biologicals 5 7 40 Biotech India 4 6.5 62.5 Life Technologies 6.5 NA Biodigital 3.5 6 71.43 JH Bio Innovations 4 4.72 18 Total TOP20 BioSuppliers 413.37 603.85 46.08 Total Others 148.03 206.15 46.02 Total 561.4 820 46.06 There are over 13 companies, whose sales to the biotech and life sciences sector have been in excess of Rs 15 crore. The Mumbai-Pune cluster hosts the largest number of biosuppliers. While Bangalore has big suppliers like Millipore, Sartorius and Waters India, Delhi region's big suppliers include Agilent, Becton Dickinson and Lab India. Not just the MNC suppliers, but also the distributors have focused on value addition. Most of them realize that it is not only product quality and support, but also customized process equipment and speed of delivery. The Indian engineering capabilities are coming of age now and several global companies are considering setting up joint ventures. BIG EVENTS OF THE YEAR GE acquires Amersham for $9.5 Billion ... Signals the herald of a new era for personalized medicine The strategic direction of GE is highly futuristic. While GE is a leading manufacturer of machines like Positron Emission Tomography (PET) and MRI scanners, Amersham is the leading player in the market for contrast drugs used in X-rays, CT scans, ultrasound, MRI, and PET scans. GE's management believes the acquisition will help it to create a healthcare company with broad expertise in imaging, diagnostic pharmaceuticals and drug discovery; create a group of technology and service driven healthcare businesses which will have combined 2003 pro forma revenues in excess of $13 billion. The Amersham Group employs over 10,000 people worldwide and had sales of $2.43 billion in 2002. Amersham had three main business areas: medical diagnostics, operating as Amersham Health, and protein separations and discovery systems together operating as Amersham Biosciences. Amersham Health (59 percent of total Amersham sales in 2002) develops, manufactures and distributes diagnostic imaging agents and radiopharmaceuticals for all imaging modalities that are used in medical imaging procedures. Protein separations (17 percent of total Amersham sales in 2002) develops, manufactures and distributes chromatography purification systems, membrane products and reagents that are used in the development and manufacture of biopharmaceuticals and for the laboratory scale separation of proteins for research and drug development. Discovery systems (24 percent of total Amersham sales in 2002) develops, manufactures and distributes instruments, reagents and software that are used for drug discovery, research and development with applications including protein and DNA analysis for genomics and proteomics, cellular screening and bioassays. Bio-Rad to acquire MJ Research Bio-Rad Laboratories Inc., a multinational manufacturer and distributor of life science research products and clinical diagnostics, announced that it has signed a binding letter agreement to acquire MJ GeneWork Inc., and its subsidiaries for approximately $47 million in cash. MJ GeneWorks is the parent company of MJ Research Inc. of Waltham, Massachusetts, a biotechnology company that specializes in thermal cycling instrumentation and reagents used to amplify DNA. The acquisition is subject to completion of a definitive purchase agreement and necessary government approvals. MJ Research is known to have pioneered the use of Peltier-effect technology and has introduced a number of other innovations in the thermal-cycling field. MJ Research employs approximately 300 employees. As of now most of the products are imported. The duty and taxes in states vary from 30 to 50 percent. The government has given duty relaxation to import life saving equipment. But classification matters. For example some products like ELISA reader, which is used in hospitals, diagnostic labs and research organizations for conducting HIV/Hepatitis tests have not been included in the life saving equipment. Further, inter-state taxing has not helped the industry as the prices vary in different locations. Though the government is comitted to help the industry, the paper work in completing any transaction is the biggest bottleneck. The decision of the Department of Science and Technology to give a grant of Rs 2.5 crore to the private sector R&D centers under Instrumentation Development Program (IDP) has been a positive development during the year. The National Instrumentation Development Board agreed to reimburse up to 50 percent of the recurring expenses of the private sector R&D centers recognized by the Department of Scientific and Industrial Research in India. Till now the funds that came from IDP used to be given only to government research laboratories and R&D centers at the university level. Under the IDP, the private companies will partially get the running cost meant for purchase of consumables and other items. This move is beneficial to the biosuppliers. Further with the government keen on looking into the whole issue of growth of the biotech sector, the suppliers are in a buoyant mood. Going by what the industry has targeted, FY 2005 would also see the biosupplier industry grow by 40 percent to Rs 1,150 crore. ]]> <![CDATA[BioPharma Analysis]]> https://biospectrumindia.com/news/95/2593/biopharma-analysis.html https://biospectrumindia.com/news/95/2593/biopharma-analysis.html Tue, 10 Aug 2004 16:22:00 +0530 The BioPharma industry has registered 44 percent growth on account of high growth in statin sales by Biocon. Biocon registered almost 118 percent growth in this business. The largest biopharma company was Serum Institute of India, with total sales of Rs 555 crore.The biopharmaceuticals consists of the diagnostics, vaccines, and recombinant therapeutic proteins. The biotech regulator Genetic Engineering Approval Committee (GEAC), has granted marketing licenses for many recombinant therapeutics proteins and vaccines. These include human insulin, Hepatitis B vaccines, streptokinase, erythropoietin, human growth hormone, human interleukin, granulocyte colony stimulating factor (and granulocyte macrophage colony stimulating factor (G-CSF), alpha and gamma interferon, blood factor VIII, follicle stimulating hormone, tissue plasminogen activator. Of these hepatitis B, erythropoietin, r-DNA human insulin, G-CSF are produced in India. The rest are imported and sold in the local market. Vaccines In vaccines segment, the key players include Bharat Biotech, Biological E, Cadila Healthcare, Cadila Pharmaceuticals, GlaxoSmithKline Pharmaceuticals, Haffkine Bio Pharmaceuticals, Hindustan Antibiotics, Intas Pharmaceuticals, Panacea Biotec, Serum Institute of India, Shantha Biotechnics, Wockhardt, and Wyeth. While Indian Immunologicals is the largest foot and mouth vaccine manufacturer in the world, Venkateshwara Hatcheries is a leading poultry vaccine and diagnostic manufacturer. Others like Hester Pharmaceuticals, Indovax and Agrivet Farm Care, a division of GlaxoSmithKline Pharmaceuticals are some other manufacturers of poultry vaccines in India. BioPharma PRODUCT TYPE 2002-03 (Rs Crore) 2003-04 (Rs Crore) % growth Vaccines 913 1170 28.15 Therapeutics 337 415 23.15 Diagnostics 178 260 46.07 Others 292 635 117.47 Total 1720 2480 44.19 Serum Institute of India is working on combination vaccines (hepatitisâ€“B + DPT (diphtheria, pertussis and tetanus), which is expected to launch during the year. It will become the second company after GlaxoSmithKline to launch combination vaccine in the world. Even other companies Shantha Biotechnics and Panacea Biotec are also working on combination vaccines. Indian Immunologicals will launch the r-DNA rabies vaccine, which was developed in collaboration with IISc. Most of the India biopharmaceutical companies import procedures in bulk and resell it in the local market. Companies like Serum Institute and Haffkine Bio-Pharmaceuticals export their produce to the developing countries at subsidized prices under UNICEF/ WHO programs. These companies are selling DPT, DT, Tetanus Toxoid, BCG, oral polio, measles, mumps, rubella, hepatitis B vaccine, rabies (tissue culture based), typhoid (injectable) vaccines. In 2003-04, the vaccines business registered 28.15 percent growth and accounted for 47.17 percent of the market share. Therapeutics The next biggest segment was therapeutics, with total sales of Rs 415 crore. This segment accounted for 16.7 percent of the total biopharma market share and grew by over 23 percent. Eli Lilly, Bharat Biotech International, Cadila Healthcare, Cadila Pharmaceuticals, Emcure Pharmaceuticals, Intas Pharmaceuticals, M J Pharmaceuticals, Nicholas Piramal, Novo Nordisk, Roche Scientific Company, Serum Institute of India, Shantha Biotechnics, Shreya Life Sciences, and Wockhardt are some of the big names in this segment. Biocon is likely to launch its human insulin in India this year. Several companies are investing about 5-7 percent of their total revenue on R&D programs to develop cures for diseases such as tuberculosis, HIV, malaria, cholera, dengue, cancer, typhoid, and heart diseases. Intas Pharmaceuticals has developed Granulocyte macrophage colony stimulating factor (G-CSF) and launching it under the brand name Neukine in August. Diagnostics In the diagnostics segment only a handful of companies manufacture diagnostic kits. These include Accurex Biomedicals, Beacon Diagnostics, Bhat Biotech, Bio-systems Diagnostics J Mitra & Co, Monozyme India, Span Diagnostics Ltd, Transasia Biomedicals, Tulip Group and XCyton Diagnostics. The Department of Biotechnology (DBT) has facilitated the transfer of many technologies for diagnostic kits to the industry developed at the CSIR labs. Top BioPharma Companies Company 2002-03 (Rs Crore) 2003-04 (Rs Crore) % growth Serum Institute of India 555 Biocon Ltd 200 435.37 117.69 Panacea Biotec 169.23 149.53 -11.64 Nicholas Piramal 70.64 130 84.03 Novo Nordisk 110 Venkateshwara Hatcheries 88 Wockhardt Ltd 74 84 13.51 GlaxoSmithKline 80 Bharat Serums 58 79.68 37.38 Eli Lilly 46.05 67.46 46.49 Krebs Biochem 64.26 56.88 -11.48 Indian Immunologicals 46.13 56.7 22.91 Cadila Healthcare 55 Biological E 17.06 38.48 125.56 Shantha Biotechnics 24.29 36.5 50.27 Span Diagnostics 26.77 35.62 33.06 Bharat Biotech 19.98 31 55.16 Indian Herbs Research & Supply 17.85 23.95 34.17 Haffkine Bio-Pharma 71.31 29.9 -58.07 Themis Medicare 10.1 11 8.91 Total TOP20 BioPharma 915.67 2154.07 135.25 Total Others* 805 326.03 -59.5 Total BioPharma Segment 1720.67 2480.1 44.14 Note: *Others in 2002-03 include the sale of some of this year's Top 20 companies, the figures for which were not available during the svrvey last year. These diagnostic companies are selling kits mainly in the areas of pregnancy, ovulation, estimation of T3, T4 & TSH, HIV infection, HBV infection, HCV infection, rheumatoid diseases and disorders, cancer (cervix, colon, prostate, lungs, mouth etc.), kidney function tests and fiver function tests. The total diagnostic market in 2003-04 stood at Rs 260 crore and accounts for 10 percent of the total market share of the biopharma sector. This sector grew by about 46 percent. The others primarily have been the statins business. This business was in excess of Rs 500 crore. In the last fiscal indigenously developed recombinant streptokinase was announced by Shantha and Bharat Biotech. But these products may be available this fiscal commercially. Besides these products, we may see the launch of Biocon's insulin and Intas' Neukine, a granulocyte colony-stimulating factor G-CSF, Indian Immunologicals r-DNA rabies vaccines. The market is also upbeat about the possibility of a new national biotech policy and also some changes in the regulations. The industry is hopeful and the total biopharma segment is forecast to grow by about 35-40 percent in FY 2005. ]]> <![CDATA[BioInformatics Analysis]]> https://biospectrumindia.com/news/95/4951/bioinformatics-analysis.html https://biospectrumindia.com/news/95/4951/bioinformatics-analysis.html Tue, 10 Aug 2004 16:17:00 +0530 The bioinformatics sector has seen a lot of action in recent times. Sun Microsystems, a global IT giant, announced a Center of Excellence (COE) for Medical Bioinformatics at Hyderabad, in collaboration with the Center for DNA Fingerprinting (CDFD) and the Andhra Pradesh government. The center will develop a data warehouse linking genomic data to patient generic and clinical data and develop data mining tools. It would be investing $5 million over a period of time. Tata Consultancy Services (TCS) has launched Tata Bio-Suite, a portable, versatile software package for life sciences and drug discovery. TCS developed the Tata Bio-Suite over the past two years jointly with some of India's leading academic institutes. And Wipro merged its healthcare focus as one of the verticals under its global IT services business (Wipro Technologies). These clearly demonstrate that IT services companies are joining the race for a share of the bioinformatics pie. It is not that such companies were not present in India earlier. Accelrys, Makro Technologies, IBM, Mascon Global, Systat Software, Cherrysoft Technologies and Oracle have their units in India working in the bioinformatics space. But the unveiling of the initiatives by Sun and TCS indicates the growing strength of India in this space. The bioinformatics industry is mushrooming around the IT services centers. That is why we see a lot of companies based in the South-Bangalore, Hyderabad and Chennai with few companies in the North. Accelrys, Bigtec, Genotypic, Jalaja Technologyis, Infosys, Kshema Technologies, IBM India SysArris Software, Systat Software and Strand Genomics are some of the leading names that have a base in Bangalore. Similarly in Hyderabad, there are several companies in the bioinformatics space. BioMed Informatics, GVK Biosciences, Caliber Technologies, Bijam Biosciences, a company of the Nagarjuna group, BioMakro, Helix Genomics, Molecular Connections, TCS, Ocimum Biosolutions and Shakti Bio Systems are based in Hyderabad. In the North there are a few companies like Mascon, LabVantage Solutions, Apticraft Systems and Fundastik Solutions. There are only a couple of companies like SAS India, SciNova Technologies and VLife Sciences Technologies in the west. The industry is small and is estimated to be Rs 80 crore in size. The Indian players are also small but they have been developing global products and quality services. Strand Genomics, SciNova Technologies, Mascon Life Sciences, Ocimum Biosolutions, Lab Vantage, VLife Sciences, Helix Genomics have come up with a suite of products which are gaining global acceptance. ]]> <![CDATA[BioIndustrial Analysis]]> https://biospectrumindia.com/news/95/1246/bioindustrial-analysis.html https://biospectrumindia.com/news/95/1246/bioindustrial-analysis.html Tue, 10 Aug 2004 16:15:00 +0530 Enzymes are used in many industries like healthcare, starch processing, breweries and distilleries, industrial alcohol, textile processing, garment and denim washing, detergent and cleaning aids, leather processing, baking and flour milling, food processing, animal and fish feeds, natural extracts and waste treatment. Enzymes have potential use in many ways in these sectors. In the leather industry, enzymes help in rapid scud loosening, wetting and degreasing, removal of adhering fatty tissues from the skin. Apart from these, many more applications have attracted entrepreneurs to look at this sector as a lucrative one. In paper pulping, xylanases are sometimes used to avoid the need for chlorine. This technology has been around for about 10 years, but its impact on chlorine use has been modest because of the associated cost and impact on yield. Detergents is an old and well established market for industrial enzymes that include proteases, amylases, cellulases and lipases. In textiles, a fairly well-established application for enzymes is the fading of denim. However, consumption is no longer as steady as it used to be, now that most of the world's denim is produced in India and South America. The leading Indian companies in the sector include Biocon (66.5 crore), Novozyme (65 crore), , Advanced Biochemicals (30 crore), Rossari Biotech (24 crore) and Maps India (17 crore). The total size of the sector in India is about Rs 250 crore. The other players in the sector include Fermenta Biotech, a part of the Vasant Kumar Group, Maple Biotech, Textan Chemicals, a Chennai-based player in enzymes for the leather industry, Pappayin Produckts (India), a leading company of Keartiman Group of Coimbatore, Lumis Biotech, a Kgenix Group company, Celgen Biologicals, a subsidiary of ABL Biotechnologies, AVON Organics, Organic Solutions, Resil Biotech, a division of Bangalore-based Resil Chemicals and Sangitha Biochemicals. Many companies not only produce but also export their products to many Asian and European countries. Company 2003-04(Rs crore) Biocon 66.52 Novozymes 65 Advanced Biochemicals 30 Rossari Biotech 24 Maps India 17 TOP 5 202.52 Others 47.48 Total BioIndustrial Revenue 250 Companies like Rossari Biotech, Biocon and Zytex (India) have received the ISO certification for their facilities and processes. This shows that Indian companies are quality conscious and are meeting the international standards. Considering the opportunity in the industrial enzyme sector, agri and pharmaceutical companies like Excel Industries and Concord Biotech are making inroads into this segment. These companies produce various enzymes like amylases, proteases, cellulases, xylanases, glucoamylases, pectinases, papains, bromelain, catalases and many other eco-friendly biological products. There are few agencies and companies in India, which import enzymes for the local market. The agencies include Delhi-based Atul Brewchem, Karan Agencies of Mumbai, Southern Marketing Agency of Chengannur, Sukhjit Starch & Chemicals of Phagwara and Zytex (India). Even the Danish company CHR-Hansen has set up a shop in India to market its products used in food processing industry. There is a lot of opportunity in this sector as industry leaders put the value of the global industrial enzyme market, including applications in food and animal feed, detergents, textiles, pulp and paper, leather and manufacture of chemicals at $1.6 billion to $2 billion. The fastest growing markets are fuel ethanol, animal feed and food enzymes. Novozymes and Genencor, which holds 22 percent of the market are the global leaders in industrial enzymes. The market for industrial enzymes is growing at a healthy pace, boosted in part by demand from emerging markets, but this volume has been accompanied by downward pricing pressure as a host of smaller players compete for a piece of the pie. New applications have also helped drive demand and the industry is responding with a continuous stream of innovative products. The companies are also looking at producing different types of industrial enzymes, using all the natural methods of production, from plants and vegetable origin, fermentation-both with solid state and submerge culture techniques. Companies are also spending on R&D efforts directed not only towards development of new innovative products but also towards making them available at an economical price to customers. ]]> <![CDATA[Â BioAgri AnalysisÂ ]]> https://biospectrumindia.com/news/95/2760/-bioagri-analysis-.html https://biospectrumindia.com/news/95/2760/-bioagri-analysis-.html Tue, 10 Aug 2004 16:14:00 +0530 Undoubtedly, Mahyco Monsanto Biotech (India) is the market leader as it was the only one with the government's permission to sell Bt cotton in 2003-04. Its Bollgard sales were close to 216,000 packets during the year. Its business on account of sales, royalty, and co-licensing was Rs 54 crore. Only the seeds sales were to the tune of Rs 36 crore. Though Mahyco was the only one allowed to sell Bt cotton seeds, illegal seeds too found their way into the farms. The exact area of field cultivation was not available. Farmers were found to be using hybrid Bt cotton seeds sold under different brands. When the Central Institute of Cotton Research (CICR), Nagpur carried out PCR and ELISA tests on these cotton seeds confirmed that they had tested positive for the presence of Cry 1 Ac gene. These were not approved by the regulator, the Genetic Engineering Approval Committee (GEAC). But Mahyco estimates that Bt cotton was cultivated in nearly 92,000 hectares. This July, approvals for trials and commercial production of several hybrids of Bt cotton were given. GEAC has also approved large-scale field trials and seed production for 12 varieties of Bt cotton hybrids developed by Rasi Seeds and Ankur Seeds. These have licenced the technologies from Monsanto. Rasi seeds has launched its cotton recently. The company has priced the packet at Rs 1600. While Mahyco is Monsanto's partner in India, Rasi Seeds and Ankur Seeds are the sub-licensees of Monsanto. Others like Nuziveedu and Prabhat agri have also opted for the germplasm from Monsato. GEAC has recently permitted Nuziveedu to conduct large-scale trials incorporating a Bt gene for two of its cotton hybrids, NCS 145 and NCS 207. The trials are on for the two Bt varieties. It plans to release the new hybrid Bt varieties in 2005. Further, Nath Seeds, Indo-American seeds, etc., are considering licensing technology from others like Syngenta. Metahelix, a Bangalore-based agribiotech company, is developing its own version, which will be submitted to the GEAC for approval this year. Certainly seed companies have realized that they have to adapt quickly to the changing market demands. That is why several of them are going to the Monsantos of the world to license the germplasms. Interestingly, some of them are working with multiple companies. Nuziveedu is working with Monsanto, National Botanical Research Institute (NBRI), Lucknow and Metahelix. India's own Bt gene too is ready for transfer. NBRI synthesized two new Bt genes and licensed it to a consortium of seven Indian seed manufacturing companies-Swarna Bharat Biotechnics Pvt Ltd (SBBPL). While the transgenic seeds market is booming, the biopesticides market has been growing moderately. Biotech International, the largest biofertilizers and biopesticides company, has grown by about 30 percent to Rs 20 crore in 2003-04. But some of the others have grown marginally. The total market for the biopesticides and biofertilizers alone is estimated at Rs 80 crore. India is emerging as an important destination for biomarkers and validation services too. According to some estimates, the cost of developing a technology in India is quite small. In the US, while the total cost including the development of gene, transformation, screening and regulatory works out to Rs 200 crore. The same in India would work out to Rs 10 crore. About 50 percent of this figure accounts for regulatory approvals. Looking ahead, this year the industry could see four to five companies selling Bt cotton seeds and it is very likely that the Bt cotton seeds would see close to 40 percent rise in sales. ]]> <![CDATA[Energizing Human Lifestyle]]> https://biospectrumindia.com/news/95/2704/energizing-human-lifestyle.html https://biospectrumindia.com/news/95/2704/energizing-human-lifestyle.html Tue, 10 Aug 2004 16:06:00 +0530 Enzymes are used in many industries like healthcare, starch processing, breweries and distilleries, industrial alcohol, textile processing, garment and denim washing, detergent and cleaning aids, leather processing, baking and flour milling, food processing, animal and fish feeds, natural extracts and waste treatment. Enzymes have potential use in many ways in these sectors. In the leather industry, enzymes help in rapid scud loosening, wetting and degreasing, removal of adhering fatty tissues from the skin. Apart from these, many more applications have attracted entrepreneurs to look at this sector as a lucrative one. In paper pulping, xylanases are sometimes used to avoid the need for chlorine. This technology has been around for about 10 years, but its impact on chlorine use has been modest because of the associated cost and impact on yield. Detergents is an old and well established market for industrial enzymes that include proteases, amylases, cellulases and lipases. In textiles, a fairly well-established application for enzymes is the fading of denim. However, consumption is no longer as steady as it used to be, now that most of the world's denim is produced in India and South America. The leading Indian companies in the sector include Biocon (66.5 crore), Novozyme (65 crore), , Advanced Biochemicals (30 crore), Rossari Biotech (24 crore) and Maps India (17 crore). The total size of the sector in India is about Rs 250 crore. The other players in the sector include Fermenta Biotech, a part of the Vasant Kumar Group, Maple Biotech, Textan Chemicals, a Chennai-based player in enzymes for the leather industry, Pappayin Produckts (India), a leading company of Keartiman Group of Coimbatore, Lumis Biotech, a Kgenix Group company, Celgen Biologicals, a subsidiary of ABL Biotechnologies, AVON Organics, Organic Solutions, Resil Biotech, a division of Bangalore-based Resil Chemicals and Sangitha Biochemicals. Many companies not only produce but also export their products to many Asian and European countries. Company 2003-04(Rs crore) Biocon 66.52 Novozymes 65 Advanced Biochemicals 30 Rossari Biotech 24 Maps India 17 TOP 5 202.52 Others 47.48 Total BioIndustrial Revenue 250 Companies like Rossari Biotech, Biocon and Zytex (India) have received the ISO certification for their facilities and processes. This shows that Indian companies are quality conscious and are meeting the international standards. Considering the opportunity in the industrial enzyme sector, agri and pharmaceutical companies like Excel Industries and Concord Biotech are making inroads into this segment. These companies produce various enzymes like amylases, proteases, cellulases, xylanases, glucoamylases, pectinases, papains, bromelain, catalases and many other eco-friendly biological products. There are few agencies and companies in India, which import enzymes for the local market. The agencies include Delhi-based Atul Brewchem, Karan Agencies of Mumbai, Southern Marketing Agency of Chengannur, Sukhjit Starch & Chemicals of Phagwara and Zytex (India). Even the Danish company CHR-Hansen has set up a shop in India to market its products used in food processing industry. There is a lot of opportunity in this sector as industry leaders put the value of the global industrial enzyme market, including applications in food and animal feed, detergents, textiles, pulp and paper, leather and manufacture of chemicals at $1.6 billion to $2 billion. The fastest growing markets are fuel ethanol, animal feed and food enzymes. Novozymes and Genencor, which holds 22 percent of the market are the global leaders in industrial enzymes. The market for industrial enzymes is growing at a healthy pace, boosted in part by demand from emerging markets, but this volume has been accompanied by downward pricing pressure as a host of smaller players compete for a piece of the pie. New applications have also helped drive demand and the industry is responding with a continuous stream of innovative products. The companies are also looking at producing different types of industrial enzymes, using all the natural methods of production, from plants and vegetable origin, fermentation-both with solid state and submerge culture techniques. Companies are also spending on R&D efforts directed not only towards development of new innovative products but also towards making them available at an economical price to customers. ]]> <![CDATA[Syngenta to acquire Golden Harvest for $180 million]]> https://biospectrumindia.com/news/95/8138/syngenta-to-acquire-golden-harvest-for-180-million.html https://biospectrumindia.com/news/95/8138/syngenta-to-acquire-golden-harvest-for-180-million.html Tue, 13 Jul 2004 18:24:00 +0530 Syngenta to acquire Golden Harvest for $180 million Syngenta announced an agreement to acquire a 90 percent stake in the Golden Harvest group of companies for $180 million including expected balance sheet adjustments. The Michael Pragnell group, which had combined seeds sales of $167 million in 2003, is valued at $200 million. The current owners will retain a 10 percent stake. The acquisition of Golden Harvest, which has a US market share of 4 percent in corn and 3 percent in soybean, together with the recently announced acquisition of Advanta's Garst business, is expected to take Syngenta's share of these markets to 15 per cent and 13 per cent respectively. This further gives the scope to introduce its range of biotech input traits from 2005. Michael Pragnell, chief executive officer, Syngenta, commented, "This acquisition marks the completion of our strategy to develop critical mass in the US corn and soybean seeds market, complementing our leading position in crop protection." Golden Harvest is the largest independently owned seed brand in the US and one of the fastest growing agricultural seed brands. Golden Harvest brand of hybrid corn, soybeans, sorghum and alfalfa is produced and marketed by five family-owned and managed seed companies serving farmers throughout the US Corn Belt, Europe, South America, and Canada. Mitsui to take 20% stake in Quintiles Japan Mitsui & Co Ltd is expected to become a 20 percent shareholder in Quintiles Transnational Japan KK (Quintiles Japan). This transaction is designed to accelerate Quintiles Japan's growth and expand Quintiles and Mitsui's strategic alliance capabilities in pharmaceuticals, biotechnology and healthcare. Quintiles and Quintiles Japan are expected to receive a total of approximately $80 million in the transaction. "I believe Mitsui will become an important partner for Quintiles Japan by contributing both tangible and intangible business resources. This transaction fits well with our goal to invest in first-rate international companies in the healthcare and service sectors and, in particular, to enhance those companies' Japanese operations," commented Osamu Mori, chief operating officer, financial markets unit, Mitsui & Co. The growth plans include expansion of core product development and commercial services and involving partnering agreements with companies seeking to enter or grow in Japan and with Japanese companies seeking to expand globally. Japan-based Mitsui is one of the world's leading and most diversified trading companies with global sales of $112 billion in 2003. Medarex to purchase Ability Biomedical Medarex Inc., a biopharmaceutical company focused on the discovery and development of therapeutics to treat life-threatening and debilitating diseases, has announced to acquire Ability Biomedical Corp., a privately held Canadian biotechnology company, including Ability Biomedical's intellectual property related to IP-10. IP-10, also known as CXCL10, is a protein believed to be associated with a variety of immune disorders, including multiple sclerosis, Donald L Drakeman rheumatoid arthritis, inflammatory bowel disease, chronic obstructive pulmonary disease and type I diabetes. Medarex is currently investigating MDX-1100, a fully human antibody that targets IP-10, in preclinical studies and expects to file an Investigational New Drug (IND) application with the FDA for MDX-1100 in the first half of 2005. The deal is valued for approximately $4.7 million in a combination of cash and/or Medarex stock and is expected to be completed in August 2004. "We have been pleased with our previous collaboration with Ability Biomedical, and we believe that this acquisition strengthens our position to develop antibody therapeutics to a potentially important target implicated in many inflammation and autoimmune diseases," said Donald L Drakeman, president and CEO, Medarex. Its product pipeline is based on a variety of therapeutic antibody products developed through the use of its UltiMAb technology. QLT, Atrix combine QLT Inc. and Atrix Laboratories Inc. have announced to combine to create leading profitable biopharmaceutical company focused on ocular, oncology, dermatology and urology with rich portfolio of products, pipeline and drug-delivery technologies. The deal is estimated at $855 million in stock and cash. Paul Hastings "This transaction will accelerate both companies' strategic initiatives and creates a world class biopharmaceutical company with multiple partnered commercial and near commercial products, a strong and diverse revenue base, a robust pipeline," said Paul Hastings, president and chief executive officer, QLT Inc. Atrix is a recently profitable specialty pharmaceutical company with a rich pipeline of products and unique drug delivery platforms. It received FDA approvals for three new drug applications within the last two years. QLT, on the other hand, has established a strong base in ocular disease and has a growing focus in other therapeutic areas including dermatology, oncology and urology. As per the deal the combined entity will diversify its revenue base and product portfolio with two lead marketed products, Visudyne for age-related macular degeneration (AMD) and Eligard for prostate cancer. Further, they will have two additional products on the market by 2005, an improved 6-month, sustained release formulation of Eligard and Atrisone, a topical acne product. It is believed that Visudyne (QLT) is the only drug approved for the treatment of wet AMD and has been used in more than 250,000 patients worldwide. Visudyne is commercially available in more than 72 countries for the treatment of predominantly classic subfoveal CNV and in over 40 countries for occult subfoveal CNV caused by AMD. CTI Molecular to acquire Concorde Microsystems CTI Molecular Imaging Inc., a leading provider of Positron Emission Tomography (PET) equipment, molecular imaging biomarkers and services, is to acquire Concorde Microsystems, which leads in small animal PET systems for imaging laboratory animals used in medical research. "Concorde has chosen to join CTI Molecular Imaging because of its unique capabilities in molecular imaging," said Robert Nutt, president and chief executive officer, Concorde Microsystems. "CTI's resources in PET technology and new biomarker development make it the best positioned company to capitalize on the promise of molecular medicine, and Concorde can help to further CTI's leadership in this endeavor." The total consideration FOR this acquisition is expected to be $41 million in cash and unregistered shares of CTI's common stock. ]]> <![CDATA[SPL Labware forays into Indian Market]]> https://biospectrumindia.com/news/95/2161/spl-labware-forays-into-indian-market.html https://biospectrumindia.com/news/95/2161/spl-labware-forays-into-indian-market.html Tue, 13 Jul 2004 18:19:00 +0530 SPL Labware forays into Indian Market Korea-based SPL Labware (SPL), a bioscience labware manufacturer, has launched its operations in India through Hysel India Pvt Ltd. VS Narayanan, managing director, Hysel informed, "We have recently signed a MoU with SPL to market their entire range of products in India. We expect a good market for SPL's products here as the initial few customers are satisfied with the performance of these products." According to Narayanan SPL's clientele in Korea include the leading establishments like the Korean National Institute of Health, Korea Food and Drug Administration, the Rural Development Administration, Korea Institute of Science and Technology, Korea Advanced Institute of Science and Technology, National Cancer Center, Korea Cancer Center Hospital, university hospitals including Seoul National University Hospital and many research institutes in the private sector. SPL was founded in May 1987 as Sewon Precision Industry Co. to design and produce injection Molds and plastic products. SPL developed and succeeded with the surface treatment technology of high polymer plastic in 1994 and started the production of the cell culture dish. The name of the company was changed to SPL Labware in January 2001. SPL supplies its products to over 1,200 laboratories. Mabtech's ELISpot hits the Indian market The Swedish Biotech major Mabtesh will supply its high quality ELISpot reagents in India through Jain Biologicals Pvt Ltd, which is in Panchkula, near Chandigarh. Lalit Jain, managing director, Jain Biologicals informed that he was satisfied with the initial feedback from customers. The ELISpot assay is a simple and sensitive assay for analysis of cell activation at the single-cell level. It is particularly useful for analyzing specific immune responses to whole antigens or peptides. Depending on the cytokine analyzed, the assay can be used to identify and discriminate between responses by different subsets of T cells (e.g., Th1 and Th2 cells). Hybrigenics optimizes protein-interaction mapping Hybrigenics, the pathway-based drug discovery company, has enhanced its protein interaction mapping services for the drug discovery industry by integrating Millipore's Montage PCR384 and SEQ384 kits. The use of these kits is believed to improve and simplify the automation of Hybrigenics' process used to analyze complex cellular pathways. Based in Paris, France, Hybrigenics SA is a specialized provider of large-scale protein interaction technology and information for the drug discovery industry. Axygen to distribute Corning's products in India Corning Life Sciences has joined hands with Delhi-based Axygen Scientific Pvt Ltd. Axygen will market Corning's entire range of life science products in the Indian market. Corning Life Sciences specializes in polymer science, biochemistry and molecular biology, glass melting and forming, surface modification and characterization science. Navneet Trehan, director, Axygen informed, "The Indian scientific bay is already familiar with the quality of Corning's products." This tie up was announced in Jaipur, Rajasthan, where Axygen's entire team attended the company's distributor "family meet 2004" and got familiarized with Corning's product range. Jeri McMohan, global product manager, Corning Life Sciences, who was present at the launch, said, "I am very pleased to see the kind of interest that each and every employee of Axygen India has shown and am confident that this relationship will produce some good examples." Corning Life Sciences also offers custom capabilities such as special packaging, bar coding and printed lot numbers. Its key areas of expertise include assay and HTS, cell culture, liquid handling and laboratory filtration. Thermo launches LIMS training facilities Thermo Electron Corp. has inaugurated its modernized training facilities in Altrincham, UK and Woburn, MA. The latest hardware and software technology has been utilized to facilitate advanced training techniques and to enhance the learning experience for users of LIMS and other laboratory informatics solutions. For a limited time Thermo will offer special pricing for new training courses purchased at these facilities, according to company release. Thermo Electron is offering customers a special incentive to experience this informatics-training environment. The promotion includes attendance at any three informatics training courses for a special fixed price that represents savings of up to 50 percent. Training vouchers are valid for 12 months from the date of issue and can be used with any of the qualifying courses within this period. Alfa Laval, Haldex create Alfdex The two Swedish multi-national companies Alfa Laval and Haldex have created a jointly owned company, Alfdex AB (a 50:50 equity joint venture) to serve the market with high efficiency solutions for cleaning crankcase gases. Alfdex will use Alfa Laval's unique and long tradition in centrifugal separator technology and Haldex' skills in serving the vehicle industry with high performance systems. Alfdex has been formed to function as the formal license taker of the technology as well as being the central coordinator of the activities. Mats Ekeroth, who has been heading the project since 2002, has been appointed president of Alfdex AB. The release quoting Mats Ekeroth, president of Alfdex, said, "There has been a great interest for the Alfdex separator and most of the engine manufacturers have already done their initial tests. Moreover, the process to adapt the Alfdex Separator to specific engine projects are already in process with many engine manufacturers." Bio-Rad to acquire MJ Gene Work Bio-Rad Laboratories Inc., a multinational manufacturer and distributor of life science research products and clinical diagnostics, announced that it has signed a binding letter agreement to acquire MJ GeneWork Inc., and its subsidiaries for approximately $47 million in cash. MJ GeneWork is the parent company of MJ Research Inc. of Waltham, Massachusetts, a biotechnology company that specializes in thermal cycling instrumentation and reagents used to amplify DNA. The acquisition is subject to completion of a definitive purchase agreement and necessary government approvals. MJ Research is known to have pioneered the use of Peltier-effect technology and has introduced a number of other innovations in the thermal-cycling field. MJ Research employs approximately 300 employees. BD to make vaccine delivery safer with BD UnijectTM For the first time in India, three majors players in this industry, Panacea Biotec, Chiron Vaccines and Becton Dickinson (BD) have come together to offer combination vaccines in a single use delivery system. BD's Uniject, a single-use prefilled device, will be used to administer the combination vaccine shots. BD India has the license for production, distribution and marketing of the device. Masood Alam, head commercial operations, Indian subcontinent, Chiron Vaccines, said, "The new concept of combination vaccine in BD Uniject would not only increase the immunization substantially in India but will also change the way immunization is done." The global experts on the subject also emphasized the need of combination vaccines and the BD Uniject device at Pedicon 2004, an annual event organized by Indian Academy of Paediatrics (IAP). Cambrex completes expansion of cGMP production capacity Cambrex, a diversified life science company, has announced the completion of the expansion of cGMP contract biologics production capacity at its Hopkinton, Massachusetts' facility. The manufacturing suites contain 2,800-liter production fermentor, 280-liter feed tank, continuous-flow centrifuge, high-pressure homogenizer, and 500 to 2500-liter process vessels for recovery, extraction and refold operations. The two Cambrex contract biologics manufacturing facilities located in Hopkinton, Massachusetts and Baltimore are FDA/EMEA approved to produce licensed products for the US and Europe. Agilent, TGen collaborate on microarray use for cancer research Agilent Technologies Inc. has entered into a collaboration with the Translational Genomics Research Institute (TGen) on a breakthrough application of oligonucleotide microarray technology called Comparative Genomic Hybridization (CGH) that could greatly enhance researchers' ability to identify and precisely locate genetic alterations that contribute to cancer. This collaborative effort will validate and further develop commercial microarray-based CGH solutions based on Agilent's custom in situ manufacturing process, in which DNA oligonucleotides are synthesized base by base directly on a glass slide. The release noted that the speed, simplicity, sensitivity and widespread availability of CGH assays employing these oligonucleotide microarrays could significantly accelerate the pace of genomic disease research. Invitrogen releases first microarray with yeast proteome Invitrogen Corp. has announced the upcoming launch of the Yeast ProtoArray, the first commercial release of a comprehensive protein microarray, or protein chip, for general research applications. This technology permits simultaneous and rapid screening of thousands of proteins in a miniaturized format that is compatible with standard laboratory equipment. The release of the Yeast ProtoArray is an important step toward applying this powerful microarray technology to protein studies in humans, and as a result Invitrogen also announced its intent to release microarray chips containing collections of human proteins beginning in the fall of 2004. Delhi-based Life Technologies is an exclusive supplier of Invitrogen's range of products in India. We See 25-30% Growth Every Year.We See 25-30% Growth Every Year. Jerold Martin, senior vice president and global technical director, Pall Life Sciences, USA Jerold Martin was in Mumbai recently to address a conference on "technological challenges in biotech processing". He has over 27 years of industrial experience and a strong understanding of separation technologies. He spoke about the direction that Pall is taking. W hich are the new technologies that Pall Life Sciences plans to launch in India? Pall is introducing several new technologies for biotechnology drug manufacturing in India. These include preparative chromatography columns with unique pack-in-place features for greater performance, reliability and product purity. These columns can also be provided as part of fully automated process chromatography systems built by Pall. We are introducing ion exchange membrane based chromatography units for final polishing to remove DNA, host cell proteins, viruses and endotoxins. These provide rapid and low cost means to ensure freedom of trace contaminants in final products. Other new technologies include new aseptic connection devices that enable two sterile components to be safely joined, while maintaining a sterile pathway, anywhere on the production floor without the need for capital equipment such as clean air hoods or tubing welders. We are also introducing new cell harvest, protein ultra filtration, buffer filtration and virus removal filter products to enhance productivity and product purity while improving process economics. How do you foresee the opportunity for your products in the Indian market? There is a strong growth opportunity for our technologies and products holds in India, as the biotechnology drug development and manufacturing sectors in India are expanding. India is the third largest in Asia after China and Korea in terms of biotech investments. This portends for significant growth in the next 5-10 years. Further, the application of World Trade Organization patent protection will facilitate development and production of new, world-class drugs in India. We are projecting 25-30 percent growth per year for our Life Sciences business over the next five years. Will you step up your base in India? We are taking several initiatives to expand our business. This year, Pall Corp. invested in our prior joint venture to make Pall India a 100 percent subsidiary. We have opened a new office in Mumbai with expanded on-site laboratory facilities to aid customers in process development and validation. We have brought in experts from the UK and the US to conduct customer visits and public seminars on the latest developments in biotech drug manufacturing technologies offered by Pall and to provide advanced training for our sales and technical staff. We are also actively hiring several additional sales and technical support personnel to expand our customer interactions. Are there any regulatory problems troubling you in India? No. In fact, increased regulatory scrutiny of product quality specifications and GMP is a driver for our business. The more customers need higher purity and world-class production equipment and services, the more they rely on Pall. Narayan Kulkarni ]]> <![CDATA[How soon can the government do enough for biofuels?]]> https://biospectrumindia.com/news/95/1940/how-soon-can-the-government-do-enough-for-biofuels.html https://biospectrumindia.com/news/95/1940/how-soon-can-the-government-do-enough-for-biofuels.html Tue, 13 Jul 2004 17:54:00 +0530 How soon can the government do enough for biofuels? Biofuels have caught the attention of many entrepreneurs. Few have taken the plunge, enticed by the large tracts of oil-bearing plants like Jatropha and Ponghamia. However, the scores of entrepreneurs are facing many roadblocks. It has been more than a year now since Naturol Bioenergy started pursuing a biodiesel project. Inspired from similar projects in Brazil, complete with a plan to bring about 120,000 acres of dry wasteland under energy crop cultivation in Andhra Pradesh, the company went ahead and announced its Rs 135 crore integrated biodiesel plant this June. However, this joint venture of Naturol with Energea Gmbh, Austria and Fe Clean Energy Group Inc., USA is far from taking concrete shape, admits Bhaskar Chalasani, CEO and MD of the company. To be located in Kakinada the timeline of the project is difficult to predict. Construction will take about 15 months and closure of finances is in limbo as the investors play wait and watch to the government policy. Same is the case with just about every entrepreneur currently sizing up the biodiesel opportunity. "We are looking forward to the government stand on incubating the biodiesel industry," said Satish Kumar, MD , Southern Online Biotechnologies Ltd. It has been over two years since the company has been trying to diversify into biodiesel manufacturing and 2007 is when Kumar foresees some real action on the scene. That an ISP provider like Southern Online saw potential in the biodiesel industry enough to stick around even when the progress is snail-paced speaks volumes about the promise of the opportunity and the attendant sustainable development. There are many like him waiting to seize the opportunity. Some are even taking the captive cultivation route. But Kumar finds it impractical to even try and exercise control over the raw material. "It should be left open and treated like any other commodity and it will find a balance. The point is to educate the farmers that this has economic potential," he said. The viewpoint is contended by Chalasani, who believes raw material availability on a commercial scale is what the industry would revolve around. "It is important to have some government assurance as a guarantee against the fluctuating prices in the commodity market," he elaborated. The dynamics of the issue are complex as the government grapples with preparing a workable package for the farmers, said MG Gopal, the secretary for Rain Shadow Area Development, Government of Andhra Pradesh. "In a couple of months there will be clarity on the policy as well," he added citing inability to commit to a timeline. Tying the industry with the welfare of the farmers is adding to the complexity but is central to the industry. The biggest announced project so far by Naturol, is said to have a potential to create 12,000 jobs in the agri sector in AP. This value proposition is the driving force but the progress is too slow to be in tune with the strides in biodiesel use around the world. When an industry has a potential to create employment and benefit especially the marginalized farmers, which is a high priority on the agenda of the present government at the center the expectations from the government are also high. The question is how soon can the government do enough to boost the industry? Nandita Singh, CyberMedia News nanditas@cmil.com Stalling: Is it a right move?Stalling: Is it a right move? Succumbing to pressure from the employees' union of the Haffkine Institute, the government of Maharashtra has stalled the sale of a piece of land at the Institute. On 9 June over 300 employees of the Haffkine Institute for Training, Research & Testing staged a dharna in front of the institute in Mumbai to protest the Maharashtra government's decision to sell 1,826 sq. m of land to the Enterovirus Research Centre (EVRC) of the Indian Council of Medical Research (ICMR). With the intervention and assurance from the state health minister Digvijay Khanvilkar the dharna was withdrawn. And the EVRC was not able to buy the land. The EVRC, housed at the premises of the Haffkine Institute, was upgraded in 1981 as a permanent research center of ICMR from a research unit. It has been engaged in studies on all major enteroviruses, including poliomyelitis and is now interested to expand its activities at the premises. The EVRC is located in the midst of nine major hospitals and research institutions at central Mumbai, Parel. Even the other permanent research centers of ICMR, like the National Institute for Research in Reproductive Health, Institute of Immunohaematology and Genetic Research Center are also located close to EVRC. Based on the experimental data obtained, the center offers suggestions on national policies relating to the control of poliomyelitis, especially on the strategies of vaccination. The problem Sprawling over 27 acres in Parel, central Mumbai, the Haffkine Institute established in 1897 was handed over to the Maharashtra government in 1960. The institute is governed under the Society and Trust Act and comes under the purview and administrative jurisdiction of the charity commissioner. It is provided with 100 percent grants by the state government. Considering the facilities available at the Institute many pharmaceutical companies have become its clients and are using its bioavailability testing facilities. The institute has emerged as a multi disciplinary, full-fledged biomedical research center engaged in research on various aspects of infectious diseases. In 1975 the production unit of the institute was segregated to form Haffkine Biopharmaceuticals Corporation Ltd, under Company's Act and the training, research and testing activities of the institute was strengthened through the inception of several new departments. The general secretary of the employees' organizationâ€“Shramik Utkarsha Sabha (SUS), Vijay Kamble, who led the dharna told BioSpectrum, "We are not against the selling of the land or research activities at the Institute's premises. Our interest is in the welfare of the employees and at same time growth of the R&D activities in the state." In 1989 the Maharashtra government decided to use the vacant space at the Haffkine Institute to develop a Biotechnology Park. But it did not materialize. In 1996, the state government allotted a piece of land to ICMR but retracted its order later. Sources now say that there is no vacant piece of land at the institute. The past The Karnataka government too had faced a similar situation after the announcement of its Millennium Biotechnology Policy in 2001. The state government was interested in setting up a biotechnology park at the premises of the University of Agriculture Sciences, Bangalore. In a similar drama the state government succumbed to pressure from the employees and students of UAS, who expressed concerns about the environmental issues, raised their voice against this decision and staged a protest, forcing the government to roll back its decision. The situation in Mumbai is a similar one. The dharna, which was held in support to express the anguish of the employees and in fulfilling their demands, is expected to create problems for those who are interested in setting up R&D and clinical research units in Mumbai. At present the state government is working on a focused project to develop Mumbai as clinical research hub utilizing the facilities it has at Parel. The latest developments have forced the EVRC to think twice about its expansion plan at Haffkine Institute's premises. According to the sources, the EVRC is looking at some other locations in Mumbai. This may prove to be a setback for the research initiatives at Parel. In the interest of the growth of the sector, the government without bowing to the pressures has to take an appropriate step to sort out the employees' problems and to promote clinical research in the state and particularly in Mumbai. Narayan Kulkarni narayank@cmil.com ]]> <![CDATA[Phage Research]]> https://biospectrumindia.com/news/95/7261/phage-research.html https://biospectrumindia.com/news/95/7261/phage-research.html Tue, 13 Jul 2004 17:48:00 +0530 Gangagen Phage Research In India, it is rare to come across companies that break the mould of conventional research and get into challenging and relatively unknown fields. Gangagen is one such. Gangagen owes its existence to Dr J Ramachandran, a renowned molecular biologist, who happened to watch a BBC documentary in 2000 on phages. The programme discussed how phages (or bacteriophages), which are viruses that kill bacteria, are used to treat bacterial infections with a huge degree of success in Russia. Despite Dr Ramachandran's wide and varied experience in research on antibiotics and bacterial infection, phages were totally new to him. This set his mind racing on the possibilities for breakthrough research on phages. Having dealt with bacterial infections in the pharma research industry, he was suddenly hopeful that the solution lay in phages. An Idea that Paid Off Enthused by the bright prospects, Dr Ramachandran acted swiftly by starting a company called Gangagen Biotechnologies Pvt Ltd. He floated the idea to Bangalore-based ICF Ventures, which pooled an initial investment of $2 million. He roped in molecular biologists Dr Sriram Padmanabhan and Bharati Sriram, who left their lucrative jobs to answer the calling of innovative research. The company kicked off operations in September 2000 by renting 800 sq. ft space, infrastructure and people at Bangalore Genei. Their first job was to create a comprehensive "library" of infectious bacterial samples and phages from hospitals in Bangalore, Vellore and Hyderabad. According to Dr Ramachandran, phages are easy to find and the best samples can be obtained in the unlikeliest of places, from river waters to temple ponds to even sewage. Globally, there are a handful of phage research companies, scattered across countries like the US, Canada, Russia, Georgia and Israel. To make headway and create a niche for the company, Dr Ramachandran went for an out-of-the box approach. It was a known fact that once a phage attacks a bacterial cell it synthesizes its own proteins, multiplies prolifically, kills the host and bursts out of the host cell in a process called lysis. Although the bacterial cell would be destroyed in the process, there is a potential harm from the release of dangerous endotoxins and the body's own immune system, which could respond by producing antibodies. This, Dr Ramachandran thought could be prevented if the phages could somehow be contained within the host cell after killing the bacterium. He filed a patent for this concept and Dr Padmanabhan and his team started work to bring about this process. The team succeeded. Phages encoded two proteins-holins and endolysin, for causing cell lysis. What the Gangagen scientists did was to introduce a recombinant gene that was deficient in endolysin protein. The result: the genetically modified phage gets rid of the bacteria and at the same time is restricted within the host cell. The body in turn eliminates the bacteria harmlessly. " We are the only company in the world to hold IP on this technology and it has given us a competitive edge that cannot be bettered by others," said Dr Padmanabhan, who heads the molecular biology division. Dr Ramachandran filed the full patent application in August 2002. Another patent followed for whole cell vaccines that contain phage-filled cells. "Experiments on animals have shown that these phages have countered infection effectively," said Dr Goda Krishna, business and operations manager, Gangagen, Bangalore. "We Need a Novel Alternative to Antibiotic Drugs." -Dr J Ramachandran, founder and president of Gangagen Inc. Dr J Ramachandran is a veteran from the biotechnology and pharmaceutical industry, who has served earlier as head, R&D, Astra Zeneca, Bangalore. He was also president of Astra Biochemicals Pvt Ltd and of the merged entity AstraZeneca India. He is credited with discovering and developing new therapies for tackling tuberculosis and antibiotic resistant infection. He has also been associated with leading US biotech companies like Neurex and Genentech in California. With such a formidable research record, it seems only natural that he made the natural progression to a new path-breaking area-phage therapy. He shares his thoughts on the exciting research opportunity that phage research offers. How do you think phage research has evolved over the years and where does Gangagen figure on the map? In the 1960s scientists looked at phages only as a model and didn't concentrate on the therapeutic aspects. The phage DNA model was the hottest topic of research. This faded in the 1970s and 1980s. In the last decade, there has been a revival in phages because of the problem of antibiotic resistance. Phage therapy is almost 100 years old. What Gangagen is doing is developing technology to improve the quality of phage therapy. We are the only company to develop IP in this area. We have several top-notch researchers and phage biologists on our board. Some of them include Dr Ryland Young, an expert on molecular biology of phage lysis, Dr Sankar Adhya, a renowned scientist who's done considerable work on model phage lambda and Dr Carl Merill, a scientist at the National Institute of Health. At what stage of development is the company right now? It will take a while before we bring out our product. R&D takes a long time. We will be conducting clinical trials in two phases, which will take another three-four years. After that, our product has to be approved by regulatory authorities. I cannot hazard a guess about how long that could take. We will file the product in the US first. Six months after that, we will also file it internationally. We would like to license our product to interested pharmaceutical and biotechnology companies. Our phage product will cover around 80 percent of pathogens and will be for topical use. What prompted you to start work in this new field? How would you explain the different research areas of Gangagen in India and Canada? Over the years, there has been an overuse and misuse of antibiotics. Since many bacteria are getting resistant to antibiotics, there is a dire need for some novel drug. The therapeutic values of phages have been neglected for some time. It is a very exciting area. We have a diffused approach at Gangagen, which helps us to concentrate on specific areas of research. In India, our focus is on human uses of phages. We believe that a developing country like ours is in the greatest need of such therapy since most deaths here are from bacterial infections than say heart disease. Also, since phages were discovered more than 100 years ago in the Ganges, we thought it was apt to focus on human applications. The company's Canadian counterpart, Gangagen Life Sciences, does research on the veterinary and environmental applications. Canada is a country where they are proactive on environmental policies. They faced a lot of problems due to the pathogen E coli0157, which spreads from animal manure to humans. By using phages, we are trying to eliminate the pathogen in animals, plants and the environment. How expensive is phage research? Phage research involves more of microbiology and molecular biology and not expensive chemistry. We estimate a two- to three-fold cost savings compared to the R&D of antibiotic drugs. What is the investment that has gone into the company? Initially, ICF, which is based in Bangalore, pitched in with a seed fund of in $2 million in 2000. We had a second round of funding from angel investors who ploughed in another $2 million in 2002. Right now, we are in talks with VCs who can fund around $3-5 million to help with our expansion plans in Bangalore. Modus Operandi Gangagen Inc. is US-based and has two subsidiaries. Gangagen Biotechnologies Pvt Ltd (GBPL), based in Bangalore, focuses on human applications, while Gangagen Life Sciences Inc. (GLSI), based out of Ottawa, Canada, works on veterinary and environmental applications of phages. GLSI is headed by Michel Cretien, a renowned medical scientist. This division works on developing phages to get rid of bacterial infection in animals, plants and the environment. The bacterial contamination of manure that causes ground water pollution is a serious issue in Canada. The problem assumed serious proportions in 2000 when several people died after drinking contaminated water in Canada. Treating meat infected with bacteria is another issue. Several countries may make it mandatory for meat manufacturers to ensure that that their product is free from contamination. GLSI is trying to introduce phages that could be given to cattle before slaughter to pre-empt any possible dangerous infection in meat thereafter. The Indian division is currently looking at human topical applications. However, it will take around four years before the product would see the light of day. The first phase of clinical trials on the product will get underway by the end of the year. This will be followed by more trials, safety and efficacy tests in humans and getting the product approved by regulatory authorities. "Some researchers tell us that it is unethical to make them wait for so long to get a good product like this," quips Dr Goda Krishna. Future Direction GBPL's research threw up a very useful by-product, a diagnostic kit to detect bacterial infection. While the regular kits available in the market fail to detect contamination soon enough, Gangagen's kit could detect the bacterial load based on phage activity immediately. This is faster and more cost-effective, according to Bharati Sriram, who heads the diagnostics group. The company, which is yet to file a patent on the kit, thinks that this could find application in medical diagnostics, food processing and soft drink manufacturing companies. The company has mapped out the sequence of research to follow from here on. Next in line are phage research to treat oral infections, urinary tract infections and ultimately tuberculosis and cholera. "We believe that phages can also attack dormant Mycobacterium tuberculosis bacteria. So the possibilities are enormous." Around six more patents are in the offing. To strengthen its research activities, the company is in talks with VCs to raise more funds to expand the Bangalore base, especially the pharmacology and fermentation divisions. Dr Padmanabhan best describes the Gangagen experience. " We look forward to come to work everyday. This concept is a gold mine." Priya Sreenivas, CyberMedia New spriyas@cmil.com  ]]> <![CDATA[Re-think the BioAgri Regulatory System]]> https://biospectrumindia.com/news/95/1425/re-think-the-bioagri-regulatory-system.html https://biospectrumindia.com/news/95/1425/re-think-the-bioagri-regulatory-system.html Tue, 13 Jul 2004 17:47:00 +0530 LEGAL VIEW Re-think the BioAgri Regulatory System In evaluating the adequacy of a regulatory system, the purposes of the system must initially be considered. The primary purpose of any regulatory system is to protect against harm by assessing and managing the risks of potentially harmful products and activities. To ensure safety of consumers, producers, farmers and environment, governments all over the world are following regulatory mechanisms and guidelines. This effort to reduce and eliminate the potential risks resulting from biotechnology and its products is often described as "Biosafety". Several recombinant DNA products have been permitted for commercial use in many countries based on these biosafety procedures and measures. Not all countries have biosafety guidelines in place. Though there are appropriate procedures in place, the nature of these guidelines varies. For example, in Asia itself, China, India, Japan, Korea, Malaysia, Philippines, and Thailand have policies and political environments that are promotional, yet precautious. On the contrary, in Sri Lanka and Bangladesh the policies are prohibitive or preventive even for imports or pilot scale experiments. Indian Regulatory System Since 1989, biotechnology regulatory policy has emerged in an incremental, some would say haphazard, way, prompted by a variety of factors and influenced by a range of different actors, both within and outside the formal regulatory arena. The committees that form the regulatory administration of biotechnology in India have left room for doubt, at least on two counts. First, the nature of intervention of the State Biotechnology Coordination Committees and the District Level Committees in the regulatory process is not clear and this arises from the absence of the requisite information. In other words, although a decentralized structure has been provided for carrying out the regulatory functions, no real attempt seems to have been made to make it respond to the problem at hand. The second issue is the low level of transparency that the regulatory administration maintains. Competent Authorities The Rules provide for competent authorities, who have been empowered to inspect, investigate and take punitive action in case of violations of statutory provisions through the nodal department and the State Pollution Control Board or Directorate of Health & Medical Services. Review Committee on Genetic Manipulation (RCGM) Institutional Biosafety Committee (ISBC) Genetic Engineering Approval Committee (GEAC) State Biotechnology Co-ordination Committee (SBCC) District Level Coordination Committee (DLCC)   This was quite evident in the process leading to approval for commercial exploitation of the first Genetically Modified (GM) crop in India. Several questions were raised with regard to the introduction of Bt cotton. The first was that the approval for the field trials did not have the requisite level of transparency. The second was that the claims pertaining to the advantages of using this variety of cotton, particularly on the grounds that it offered an environmentally safer alternative to the pesticide-intensive cotton cultivation were not quite justified. And finally, the cost of adoption of Bt cotton could be prohibitive for the small farmers. Even though all these questions were raised, the campaign against the field trials of Bt cotton was built essentially around the point about transparency of the regulatory mechanism. Two of the more pertinent questions have been the six-committee structure that constitutes the regulatory administration. It is largely nonfunctional since only two of the Committees seem to have any role to play. These are the Review Committee on Genetic Manipulation (RCGM) and the Genetic Engineering Approval Committee (GEAC). The functions of the sub-federal committees remain largely undefined. The second question was related to the framing of rules of the committees that have a role in regulatory administration of GMOs. The regulatory administration for biotechnology in India, in the agri-biotech sector over the past several years, has suffered from the inability to set its own terms. This was despite the fact that India has been one of the first countries in the developing world to set up a mechanism for making a risk assessment of biotech products before their commercial exploitation. The setting up of the regulatory administration was even more remarkable since it took place even before the global community formally launched the process of developing the Biosafety Protocol. MS Swaminathan Task Force Recommendations There have been few attempts to explore the detailed interactions with the biotech companies themselves. The previous government had appointed the MS Swaminathan Task Force on Applications of Biotechnology in Agriculture. The Task Force has suggested that pending the establishment of an autonomous Agricultural Biotechnology Regulatory Authority (ABRA), the release, notification and registration of transgenic crops for commercial cultivation be done by the Indian Council of Agricultural Research (ICAR) and the Union agriculture ministry. The Task Force has limited the powers of the GEAC to "only environmental clearance". In the run-up to the ABRA, the Task Force suggests, approval powers for contained and open field trials for biosafety should rest with RCGM, while the multi-location field trials are the sole responsibility of ICAR and the company concerned. The Monitoring-cum-Evaluation Committee (MEC) should report to the GEAC on biosafety and environmental issues, while post-release monitoring should be the responsibility of the Union agriculture ministry and ICAR. At present, GEAC is the sole authority to deny or clear a particular Bt gene on all counts, economic and environmental. The report favors strengthening the existing Seeds Act, 1966 and Environmental (Protection) Act, 1986 to deal with the possible illegal proliferation of GM seeds. It favors mandatory registration of all released seeds and proposes a single-window information center on all aspects of bioethics and biosafety. Issues for Consideration Pre-market authority: A regulatory agency must have the ability to assess and approve a product's health and environmental safety before it goes to market, to prevent problems before they occur. Because different laws governing biotechnology were enacted at different times and for different purposes, the degree of pre-market authority given to the agencies under these laws varies widely. GMO Regulation in India In India, the use of genetic modification technology is governed by several primary legislations. The Environment Protection Act 1986 (EPA) The Rules for the Manufacture, Use, Import, Export and Storage of Hazardous Micro Organisms Genetically Engineered Organisms or Cells 1989 (Rules) The Department of Biotechnology Guidelines 1998 (DBT Guidelines 1998) Data evaluation: A regulatory agency must have the capacity to assess the quality of those data, analyze and interpret them, and draw scientifically valid conclusions. Avoiding unnecessary delays: Unnecessary delays in the regulatory process can keep valuable crops off the market thereby depriving consumers of low cost, high quality food. Biotechnology companies need some reasonable expectation of return on the large investment that technological innovation requires. Monitoring and enforcement capability: There has to be an effective national monitoring and enforcement capacity. Monitoring and enforcement has to take place on a few levels. Scientific developments globally have to be tracked and monitored daily as new scientific information is a basis for the decision-making body to review its decision. An initial criterion for an effective regulatory system is that regulatory agencies should have clear legal jurisdiction and authority over all products and activities that may pose a risk to human health or the environment. This is also important for providing the public and technology developers a clear understanding of the regulatory pathway to market. A product should not fall through the regulatory cracks because no agency has clear jurisdiction or authority. Similarly, if a product could come under the authority of one or more agencies, the agencies need to coordinate those authorities to make their respective responsibilities clear and to function in a way that is not overly burdensome. Whether a new legislation for the biotechnology industry is required to be drafted or the existing legislation be modified is a decision the government could consider to ensure that the entire legal system is consistent and workable and that the relationship among the various components is clear. By Kirit S. Javali, Partner advocates@jafajavali.com Law Offices of Jafa & Javali is a full-fledged corporate law firm with niche expertise in IPR & Biotech law, with offices in New Delhi, Bangalore and Mumbai. ]]> <![CDATA[Bangalore Gears for Bio Event]]> https://biospectrumindia.com/news/95/2699/bangalore-gears-for-bio-event.html https://biospectrumindia.com/news/95/2699/bangalore-gears-for-bio-event.html Tue, 13 Jul 2004 17:45:00 +0530 Bangalore Gears for Bio Event The annual premier biotech event will be held in Bangalore during 11-13 July 2004. The fourth edition of the annual biotechnology meet, Bangalore Bio 2004, will kick off on 11 July 2004. Organized by the Vision Group on Biotechnology, the three-day event is expected to attract good participation from leading biotechnology companies and research institutes from India and abroad. This annual event in the previous three years used to be held in April. But owing to the state and national elections in April-May, the event was postponed to July this year. Briefing media persons, Vision group chairman Kiran Majumdar-Shaw said, "The event had managed to place Indian biotechnology on the world's radar. Bangalore Bio has played a key role in profiling India's biotech industry. This year we will have delegations from 15 countries including Germany, the US, Thailand, France, Denmark, the UK and France participating in the event." More than 100 participants will exhibit their research and technology capabilities in the exhibition area spread over 4,500 sq. mts. The theme for this year is "Biotechnology for a billion people". Explaining the choice of the theme, Mazumar-Shaw said that biotechnology would have to benefit the rural population in India. "The present election outcome shows the lack of the trickle down effect of IT and BT to the masses," she added. IT, BT and Science and Technology secretary M K Shankaralinge Gowda said, "Bangalore has always been an attractive destination for the development of knowledge and R&D based industries like biotechnology. Out of 200 biotech companies in India, 100 are located in Bangalore". He added that the new government is committed to establish the long awaited BT park in Bangalore. "Around 100 acres will be allocated for this and the park will be operational in a year's time," he informed. He added that the state government wants to take Bangalore Bio to different parts of Karnataka. "Biotech Park and Employment Creation Will Get the Top Priority." MK Shankaralinge Gowda, secretary, IT, BT, science & technology, Government of Karnataka. Gowda assumed office in the middle of June 2004. BioSpectrum team caught up with the secretary on the 10th day of he assuming office and spoke to him on his priorities and plans for promoting the biotechnology industry in the state. His taking charge as the new secretary of the IT, BT, and S&T department is a significant development considering the fact that the newly elected government in the state considers biotech as an important sector for future development and growth. Though just a few weeks old into the department, Gowda has a good understanding about the industry and is all geared up to kick start the next phase of development in this sector. Excerpts from the interview with N Suresh and Srinivas Rao: A Millennium Biotech Policy was announced in 2000-01. Will there be a revision? The industry dynamics have changed during the last few years. There is a realization now that biotech has the potential to become a full-scale industry. Earlier the biotech community was also not too sure and was groping in the dark, trying to come to terms with biotech priorities. Now the biotech priorities have been identified. The state government is keen to promote biotech development in the state. At this point of time, we are trying to put together various new initiatives. The revised policy and new initiatives will be announced shortly. What will be the state's priorities ? What is good for the human health should be treated as a priority. Several companies are moving to the health care sector, as the volumes are available. Earlier we concentrated on the production part of agri biotech such as new seeds, biofertilizers ... But now per unit productivity has become very important. Value addition has become a key factor. If biotechnology can touch the lives of common people, it will produce volumes and make biotech viable. The bottomline is employment. The stakes of the local people should be there in whatever development happens in the state. What would be your priorities while promoting the sector? I would like to make the Bangalore biotechnology park a reality. Initially, there was a push for this, but latter because of some controversies the focus was lost. We are going to make a major pitch for the Bangalore biotech park. We have now acquired 100 acres of land in the Electronics city. The acquisition is over. We would now develop it as a biocluster, where inter-dependent biotech companies would be encouraged to set up operations. We will earmark 10 acres of land for IBAB (the bioinformatics institute), Center for Human Genetics, and an incubation center, which will provide the intellectual inputs for the biotech park. These three will be under our umbrella. Bangalore has the capacity to take nearly $500 million (Rs 2400 crore) in investment in five years. And the Bangalore biotech park will be developed over a period of five years. We are calling for the expression of interest by companies to develop that. It will be a joint venture. The biotechnology park will be operational within a year. Will you go to the DBT or government of India for support? If we try with government of India, they will definitely help. For example, in the IT area, when I asked STPI if they would set up a park in Mysore, Belgaum etc., they were affirmative. They wanted the space. So you need to have space to create it. If we provide the space, they will take it up. Raising money for biotech incubators will not be a problem as biotech will be a priority for the Central government too. We are waiting for the Union budget on 8 July for clues on this. Would you be launching a biotech fund? Money is not a problem. If we can show that there is viable model and an industrial unit, investment is not going to be an issue. Experimentation should happen in the incubation centers. The companies need to be in the incubation center till they become economically viable. Those who can demonstrate that they have technology and products to do volumes, raising money would not be a problem. As far as Karnataka is concerned, Rs 50 crore has been earmarked for this purpose, which will be given as soft loans to entrepreneurs. Do you plan to develop a few more bio clusters and provide fiscal incentives? We are actively considering a plan to set up a biotech park near the Karnataka University, Dharwad and develop a Marine Biotech Park at Karwar. The focus will be to develop clusters depending on the strengths of each region and on employment creation potential. With the introduction of the value added tax system next year across the country, fiscal incentives cannot be provided. The focus now has to be on developing a skilled workforce and infrastructure. Are you satisfied with the BangaloreBio preparations? BangaloreBio is shaping up well now. The confirmations indicate that the show will be as good or better than last year. Over 90 companies have already confirmed their participation. I expect this figure to grow to 100 before the event starts on July 10. Union Minister for Science and Technology Kapil Sibal will inaugurate the event. The Bangalore Bio conference, which will be held concurrently, will feature topics like R&D outsourcing, vaccines and therapeutics, diagnostics, agricultural biotechnology, clinical research and IT enabled bioservices. Some of the speakers at the meet would include renowned plant breeder Dr Gurdev Kush, Dr David Winstanley, Dr Henri Colin, Prof. NK Ganguly, Prof. Dr Rolf Werner, Dr Sumanth Venugopal and Dr Vijay Chandru among many others. Key Features The event will have four programs coinciding with the trade show-CEO Conclave, BioBusiness Awards, BioBanquet, and Awards Nite. The CEO Conclave is being organized as a special industry get-together for over 300 distinguished people like CEOs, R&D heads, VCs and investment consultants coming from diverse biotech backgrounds. The Bio Business Awards have been instituted by the Karnataka government and the Vision Group on Biotechnology to recognize and encourage the efforts of Biotech companies. Bio Business Awards for 2004 will be given away at the event. BioBanquet will ring the curtains down to Bangalore Bio 2004. It will be a sit down dinner, with a brief closing report of the event, while the Awards Nite is an evening of celebration and entertainment, where the sponsors, exhibitors, speakers, delegates and others meet. The Awards for the best stalls will be given away. Ranbaxy is the main sponsor for the event. Bangalore Bio 2004 expects to attract several trade delegations from overseas and other parts of India. This is aimed at doubling the networking-and-transactions opportunity across the board. Also invited to participate at the expo are other Indian states such as Maharashtra, Gujarat, Delhi, Punjab, Haryana, Rajasthan, Andhra Pradesh, Kerala, Tamil Nadu, Chattisgarh and West Bengal. CSIR is putting up a big pavilion. Besides the DBT, C-DAC, Intas, Panacea and Ranbaxy are some of the other big names that have confirmed their participation. Indo German Business Forum On Biotechnology has already announced that it is organizing a forum to meet German Biotech SMEs and German Economic Promotion Organizations during the show. There are several other things that were getting finalized at the time of going to print. And the industry and organizers are hopeful that BangaloreBio would meet the industry's expectations. N Suresh and Ch. Srinivas Rao ]]> <![CDATA[Why Not a BIO India Show?]]> https://biospectrumindia.com/news/95/1687/why-not-a-bio-india-show.html https://biospectrumindia.com/news/95/1687/why-not-a-bio-india-show.html Tue, 13 Jul 2004 17:41:00 +0530 Why Not a BIO India Show? The world's largest biotech industry meeting, BIO 2004, organized by the US Biotech Industry Organization, just got over. It was a phenomenal success by any industry standards. There were nearly 17,000 participants from all over the world who had gathered in San Francisco from 6-9 June for the annual event. From a sedate start in 1993 with just 2,500 participants, mainly from the US-based biotech companies, BIO has come a long way in 11 years. There is a clamor for participation. The organizers have a tough time choosing the speakers for various sessions from among the best industry professionals. For every speaker chosen, at least five equally good ones have to sit among the audience. Such is the prestige attached to the conference that just half-a-dozen ministers handling biotechnology in their government gets to address an elite audience and show case the biotech capabilities of their countries. India was very lucky as DBT secretary Dr M K Bhan got to speak at the prestigious Ministerial session. Participants from India and elsewhere, whose numbers are increasing every year, admire the meticulousness with which the event has been organized year after year. There is a lot of learning for the Indian biotechnology sector as it gears up for its own major event, the fourth edition of Bangalore Bio from 11-13 July. India's first and oldest biotech event had to be postponed from the regular April dates to July due to the elections. On the other hand, BIO has announced the dates for its annual event for all the years up to 2009. The event calendar is fixed for June. In 2005, it will be in Philadelphia, followed by Chicago (2006), Boston (2007), San Diego (2008) and Atlanta (2009). Preparations have already started for the next year's event. It helps everyone to plan their activities to make full use of the presence of global audience. Another noteworthy fact is that BIO has chapters in many American states and in countries like Taiwan and Germany. This is something our biotechnology sector should try to emulate. Our small and growing industry should conserve the energies for one big event (probably the Indian version of BIO, as BIO India) and rotate it annually to various cities. Fix the dates and venues so that everyone can work together to make this a huge success and provide a single window to the best of Indian biotechnology every year. We have a multiplicity of industry organizations dealing with biotechnology and too many events (at least three back-to-back biotech industry events have been planned for February 2005 in New Delhi, Hyderabad and Mumbai). Some of the industry leaders have informally discussed the need to consolidate the events and present a unified face to the world. These discussions should be taken forward quickly before a slew of event-related announcements are made in the coming months. The industry has to think beyond its narrow interest. Listen to what BIO's founder president Carl B Feldbaum said in his farewell speech at San Francisco: " BIO's members have not only forged a new, socially responsible identity for our young industry, but you have also forged a wholly new type of trade association, one not mired in its own narrow commercial interests and instincts, but much more expansive and contemplative in its thinking and increasingly enmeshed in the issues of access and fairness, of ethnicity, race and religion-put simple, the issues of the individuals, communities and nations that we live and work among." I am sure we can create our own successful global gathering in BIO India soon.   sureshn@cmil.com ]]> <![CDATA[The Agbiotech Task Force Report]]> https://biospectrumindia.com/news/95/1412/the-agbiotech-task-force-report.html https://biospectrumindia.com/news/95/1412/the-agbiotech-task-force-report.html Tue, 13 Jul 2004 17:38:00 +0530 Dr Suman Sahai Dr Suman Sahai The Agbiotech Task Force Report The government had appointed a Task Force to examine agri-biotechnology and make recommendations for its implementation. The Task Force headed by Dr MS Swaminathan was given the mandate to formulate a long-term policy on applications of biotechnology in agriculture; make suggestions for harmonizing decision making; recommend a role for the Agriculture Ministry and generate awareness. The importance of the recommendations of the Task Force lies in the fact that this is the first effort to formulate a policy. Civil society organizations have been frustrated in the past by the refusal of the Department of Biotechnology (DBT) to engage them in any dialogue on public concerns or be receptive to any suggestions for improving a clearly unsatisfactory system. The former head of DBT is famously on record for doggedly insisting that India did not need a biotechnology policy when all around her, from the most vocal protagonists to the most determined opponents, were demanding a national policy. The report's basic recommendation is that the national policy should seek the "economic well-being of farm families, food security of the nation, health security of the consumer, protection of the environment and the security of our national and international trade". If the recommendations of this Task Force are upheld, no policy implementation can deviate from these goals. The report highlights the need to link transgenic research in India to the international market. Transgenic research should not be done on crops that we sell in the international market, like soybean, Basmati rice and Darjeeling tea. Readers will recall the hare brained schemes of the DBT to promote Bt Basmati and introduce the beta-carotene construct of Golden Rice into Basmati rice. Nobody seemed to be thinking that we are exporters of Basmati (and other) rice as well as soybean (to special niche markets) and that our major trading partners are all rejecting GM foods. So who would buy our Bt Basmati or our GM Soya? The report is critical of the prevailing gung-ho climate when any proposal for research on a GM crop, however nonsensical the goal, is likely to get sanctioned, often at the cost of conventional research which is more likely to yield results of relevance. It recommends that all alternatives to GM technology should be examined and the GM route used only when other options are not available. There is an explicit injunction against using negative GM traits like herbicide tolerance that can reduce employment (by taking away the opportunity to earn wages by weeding) and impinge on rural livelihoods (by destroying vegetation that is used as nutritious leafy greens or fodder to support livestock). The report says that our policy on transgenics should be sensitive to biodiversity conservation and the socio-economic context of our composite agrarian system. In other words, small farmer interests have to be protected. In recommending the breeding of both varieties and hybrids and supporting apomixis as a strategy, the recommendation is clearly in favor of the farmers' right to save seed from previous harvests. The recommendation that Centers of Origin and diversity like the Jeypore tract for rice must be protected is an important one. However, the proposed mechanism for earmarking GM and non-GM zones does not appear to be feasible. If the cultivation of GM rice is permitted in certain areas but not in the diversity rich areas of Orissa, Jharkhand and Chattisgarh, there is no way of preventing GM rice landing up there. Foreign genes in that case are bound to move to wild relatives of rice in its center of origin. We have seen the speed with which the illegal Bt cotton originally put out by Navbharat seed company has spread to almost all cotton growing areas, despite the fact that its planting is illegal. Similarly, contamination of native corn in Mexico has taken place in spite of the ban on the cultivation of GM corn in the country. Zoning or segregation is unlikely to work. The only way of protecting native germplasm from foreign genes with likely negative impacts is to disallow the GM version of that particular crop. I have a disagreement on the edible vaccine strategy that forms part of the report. I do not believe India should invest in edible vaccines since it will be impossible to keep vaccine- bearing fruit separate from ordinary fruits. Mixture with the food chain is inevitable since one bunch of bananas looks like another. It would be even harder to segregate grains. In the US, Starlink corn, which was not allowed as food but only animal feed, was found mixed up with food corn. In the Prodigene case in the US, a GM corn carrying pig vaccine was found mixed up with soybean for human use, showing segregation is not possible even in the highly regulated conditions of US agriculture. India should have a strict policy of allowing the expression of pharmaceutical molecules like vaccines only in non-edible plants. With respect to regulation, the report has suggested much needed technical competence and transparency. I would have liked to see a greater role for civil society, as is the case in the Philippines and other ASEAN nations. The structure of the regulatory authority would benefit from greater autonomy. The regulatory structure should be demonstrably competent and independent to inspire confidence. It should be able not just to assess biosafety, environmental and long term ecological impact but also other aspects like social and economic impacts, particularly the impact on small farmers, of the introduction of a particular GM crop. In my view, it would be best to divide the regulatory function into two parts, one Advisory, the other Statutory. Advisory body: It should have a broad based multidisciplinary membership that includes all relevant scientific disciplines, social scientists, environmentalists, civil society groups, members of farming and adivasi communities, representatives of panchayati raj institutions and legal experts. A person of the highest technical caliber who has experience in the regulation of GM crops should head the body Overhauling the regulatory system from its currently appalling state should be high priority. Hopefully the process begun by the Task Force will help to establish a competent and participatory system and a more responsible way of evaluating which GM crops could be relevant for Indian farmers. Dr Suman Sahai has a Ph.D in Genetics and has several years of research and teaching experie nce in the Universities of Alberta, Chicago and Heidelberg. Dr Sahai is a member of several national policy forums on environment, biotechnology and Intellectual Property Rights as well as education and health. She is also the convenor of Gene Campaign, New Delhi. Suman Sahai can be reached at: genecamp@vsnl.com ]]> <![CDATA[How to Protect Bioinformatics Tools?]]> https://biospectrumindia.com/news/95/2178/how-to-protect-bioinformatics-tools.html https://biospectrumindia.com/news/95/2178/how-to-protect-bioinformatics-tools.html Tue, 13 Jul 2004 17:33:00 +0530 LEGAL VIEW How to Protect Bioinformatics Tools? Bioinformatics is beset with its own set of opportunities and challenges. Intellectual protection for developments occurring in this field is important too. Rajeshwari H Take a simple case of identification and discovery of a protein. To determine the structure of the protein, which tells a few stories about its activity and mechanism of action, bioinformatics tools come handy. These tools offer specific algorithms, which are derived from basic knowledge of chemistry, physics and analysis of other proteins, and assist in predicting the structure of the newly discovered protein in a matter of minutes shaving off several years of research. Bioinformatics also assists in placing the protein in the phylogenetic tree, which throws light on the evolutionary history of the protein. Similarly, when genomic data of various individuals is collected, a "reference library" of various genes in humans may be used to analyze the differences (polymorphism) between individuals. It is useful in predicting why someone is predisposed to a disease while another is not or even diagnose whether a person is susceptible to a specific disease. The above examples may be some very grossly simplified ones. Clearly, bioinformatics tools are designed to assist and complement research in molecular biology. Such tools require years of research and substantial investment of time and money: hence, protection is not just desirable, but necessary. IP protection Take the case of a micro-array analysis. This involves more than 1,000 wells and provides a snapshot of genes expressed at anytime. Analysis of this information by individual well-trained scientists usually takes few days. This chore is now performed by computer software. It picks up the digital photographs of each of the wells and analyzes the same and the output of several hundreds of such micro-array experiments is available in matter of minutes. The core of this micro-array technology is driven by few algorithms, some proprietary and public domain databases. It generates its own database, which gets regularly updated after each analysis cycle. The technology is licensed to users who pay a licence fee for use of the tool and are not authorized to modify the software. The subject matter for protection in this example boils down to software: specifically the database used by the software, the database generated by the software, algorithms used by the software and the manuals and other allied material. Is patent a good protection? Although not a wholesome solution, it may be an option worth exploring. A patent, we know, is granted for an invention that is novel, non-obvious and is capable of industrial application. Further, a patent is territorial in nature and therefore dependent heavily on the patent laws of each country. USA: After the US Federal Circuit clarified in the State Street Bank case that a software invention is patentable, if it produces a new, useful and a tangible result, the road for patenting software inventions became smoother. The decision also opened the floodgates for several other similar types of inventions employing software. The example described above would be patentable in the US. Similarly, software that can identify the precursor of a peptide by identifying a specific nucleotide sequence and then determining the peptide formed by the sequence may also be protected. Algorithms used for comparing sequences, finding genes, determining their functions etc. are also capable of protection. The US Federal Circuit in the AT &T case held that algorithms are patentable, if it is applied in a practical manner to produce a useful result. Given the above precedents, patentability of bioinformatics tools, essentially the software, has now become common, paving the way for grant of patents for software that enable diagnosis or testing for susceptibility based on presence of particular proteins or that which assist in determining the homology between various nucleotide sequences. Europe: According to the European Patent Office, an invention in respect of a software is patentable, if it makes a "technical contribution" over the known art. Technical contribution may be solving of a long existing problem, a means to solve the problem or technical issues to arrive at a solution for the problem. Therefore, the example stated above may be protected in Europe. India: The Indian Patents Act, 1970 (as amended) specifically provides that mathematical formulae, business methods and computer software are not patentable. However, a machine embedded software or a firmware is patentable. Therefore, the example technology may not be eligible for patent protection in India. Copyright Copyright protects an original work fixed in a tangible medium. There are several categories of works that are eligible for copyright protection, one being a "literary work". A software, whether the source code or an object code or a flow chart are all included within the category called "literary work" and thus eligible for protection under this law. Registration under copyright law is highly recommended, especially for purposes of enforcement. Copyright protection has its own advantages. It is created automatically when software is fixed in a tangible medium. Affords universal protection unlike patent law that requires registration in every country It is less expensive and the procedure for registration is simple Term of protection is life of author plus 60 years in India and could vary in each country. Legal remedies are available in many countries for violation of copyright, which may not be available for a patent infringement. Patent or copyright? Patent law protects the ideas behind software, while copyright law protects an idea as expressed. In other words, copyright extends to the software as written by the programmer and not its variations. Copyright protection does not prevent another from reverse engineering or implementing the same idea in a different manner. A patent protects the underlying idea of the software so that the path is blocked for the next entrant. Database rights Proprietary databases are integral parts of the bioinformatics tool kits. Development of such tool kits requires substantial investment in terms of time and money. In most countries including India, databases are considered as compilations and therefore eligible for protection under copyright law. The only caveat for such protection is that the database must be original in the selection or arrangement of data. A typical example of such a database is that maintained by GenBank, European Molecular Biology Laboratory, Cambridge (EMBL), SWISS-PROT (protein sequences), BLOCKS (protein motifs). Many countries are sensitive to the needs of this industry and have provided for special database rights whereby any proprietary database wherein the maker has made substantial investment in making, presenting or verifying the contents is eligible for a 15-year protection from the date of creation or date of substantial modification. In effect, these databases may enjoy perpetual protection. Trade secrets A trade secret may consist of any formula, process, device or compilation of information which is used in one's business and which gives an advantage over a competitor who does not know of it. Also known as confidential information, the essence lies in maintaining and keeping the subject matter as a secret. The owner of the secret information must take adequate steps to make sure that the information is maintained as a secret by extracting non-disclosure covenants from employees and those who use the information. The virtually unlimited monopoly that trade secret protection provides to the owner includes certain inherent risks and problems. If the proprietary software is accidentally or illegally disclosed, all protection is lost. Protection is also lost if the information enters public domain. It may run into problems if obtained illegally by industrial espionage. Despite these problems, it is a useful tool for protection of algorithms and databases. Overall strategy It is noteworthy that all the above aspects of intellectual property are not mutually exclusive in that one tool may be protected by all forms of intellectual property. Any company serious in this sector must use a combination of intellectual property rights for protection of its tools. The tool that is most appropriate depends on the position of the company and the business goals that it seeks to achieve. By Rajeshwari H rajeshwari@knspartners.com K & S Partners K&S Partners is a full-fledged intellectual property law firm with offices in New Delhi and Bangalore. It specializes in the entire gamut of intellectual property laws, protection and enforcement. ]]> <![CDATA[A "Johnny Come-Lately" Intervention]]> https://biospectrumindia.com/news/95/1852/a-johnny-come-lately-intervention.html https://biospectrumindia.com/news/95/1852/a-johnny-come-lately-intervention.html Tue, 13 Jul 2004 17:31:00 +0530 GUEST COLUMN Shanthu Shantharam A "Johnny Come-Lately" Intervention The ICMR paper on GM foods lacks scientific aptness. It is a welcome sign that the country's premier medical research body, Indian Council for Medial Research (ICMR) has woken up from its slumber to publish a "draft" position paper on how GM foods should be regulated. The question is where had they been all these years when controversies about the food safety of GM crops have been raging and when the Review Committee on Genetic Manipulation (RCGM) and the Genetic Engineering Approval Committee (GEAC) were struggling to develop regulatory standards to determine the allergenicity and toxicity of Bt-cotton and many other GM crops that have come under their purview. May be they were there, but no one noticed. It is really curious that the draft document does not mention anyone in authority at ICMR and nor is there a clue whether the document had been whetted by other ministries who have an interest in the subject. There is also no indication as to whom to contact at ICMR regarding the document's contents. Certainly, there is no indication that there were any wide-ranging stakeholder consultations before drafting the paper. Business as usual? The position paper cannot seem to distinguish between market dominance and market monopoly, and goes on to talk senselessly about how certain biotech companies will control the food chain and how small farmers will be denied access to the technology. These kinds of socio-economic concerns do not belong in the realm of ICMR's competence and should not have been dealt with in such a cavalier manner. This is a good example as to why a regulatory authority of any technology should not be in-charge of judging socio-economic impacts of a technology. They should be left to real experts who live and work in the academia and without a doubt will be finally decided by the market place once the technology products hit the market. The document asserts a regulatory role for ICMR in assessing the food safety of GM foods, but do they know that RCGM and GEAC are already doing it by the seat of their pants? Does the ICMR know a new report on regulatory reforms has been submitted to the Ministry of Agriculture by MS Swaminathan panel? ICMR seems to know not! Scientifically the document is inept at best, throws up the much hackneyed "genetic pollution", have no knowledge of the fact that there has not been any observed field based resistance to Bt-toxin and certainly is oblivious to the fact that GM pollen has not destroyed any biodiversity. Wonder why all these seemingly environmental issues needed to be brought forth in a document that purports to deal with GM food safety? Surprisingly, it does not talk of any international standards used for assessing food safety. The document suggests that available biochemical, toxicological and molecular techniques are not sensitive enough to assess health risks is a clear betrayal of lack of any information and knowledge of the subject matter on the part of the author(s) of the document. It is appalling that such an important paper as the one dealing with the regulation of GM foods be published by a premier body like ICMR at a time when there is so much misinformation, disinformation, and baseless scare-mongering is going on about the GM technology around the world. ICMR, instead of being a source of sound scientific information and knowledge, in its first document on the subject missed out a great opportunity to better inform the public. Shanthu Shantharam, Biologistics International LLC, Ellicott City, MD 21042 ]]> <![CDATA[Many Hurdles Still Remain]]> https://biospectrumindia.com/news/95/3020/many-hurdles-still-remain.html https://biospectrumindia.com/news/95/3020/many-hurdles-still-remain.html Tue, 13 Jul 2004 17:29:00 +0530 Many Hurdles Still Remain BioSpectrum in its July 2003 issue listed the Top 10 hurdles confronting the biotechnology industry. Post that there has been change of guard. The Department of Biotechnology (DBT) got a new secretary, Dr Maharaj Krishan Bhan. He took over the DBT mantle from Dr Manju Sharma in March 2004. Now, there is a new Government at the center. Besides, active biotech states like Andhra Pradesh and Karnataka have seen change in regimes. Former DBT secretary Dr Manju Sharma had asserted that biotech would be a major success in five years and that many hurdles facing this industry would have to go. That was in October 2003. Dr Bhan opines that the industry needs a comprehensive biotech policy. The new governments too have been stressing on promoting biotech and creating employment. The industry is hopeful, but it calls for speedy action and implementation. But these can happen, only by removing the many hurdles. Top Industry Hurdles Registration of biotech product Restrictions on import for certain reagents Marketing of biotech products Higher import duty on certain equipments No campaigns on awareness about the modern/newer technologies No clear policy framework Trainable manpower Over the past few months several key initiatives have been launched. For instance, the Mashelkar task force on recombinant drugs was announced and the committee met with the industry to discuss the issues in mid-May. Similarly, The Agri Biotech Task Force headed by Dr MS Swaminathan submitted its recommendations to the government. Surely, these are positive developments. But the big question is whether things have really changed for the industry since July 2003? The key challenges before the industry pointed out by BioSpectrum in July 2003 issue include multiple regulators, weak IPR policies, inadequate government support, lack of seed funds, lack of appropriate biotech education, poor infrastructure, and weak industry-institution linkages, among other things. No Clear Policy With no clear announcement on the patent regime, which should come into effect from 2005, MNCs and new entrepreneurs are hesitating to make investments in biotechnology parks. Expressing his concern on this, Balaji Rao, director, The TCG Urban Infrastructure Holdings Ltd, which is developing an International Biotechnology Park near Pune in association with Maharashtra Industrial Development Center said, "Companies are looking to the government, as the issues in biotechnology and pharmaceuticals are complex in nature." "We cannot enter each and every country just like that because of the patent and regulatory issues. More so in the case of developing countries as most of them are not ready with full-fledged regulatory systems and testing facilities. The government of India should come forward to help the industry through our embassies. This way, the products will get registered a little faster and the exports can pick up." Varaprasad Reddy, managing director, Shantha Biotechnics Pvt Ltd Also long procedural delays have been affecting the companies. And no company wants to loose revenues as a result of delays. For example, the Genetic Engineering Approval Committee (GEAC), a part of the Ministry of Environment and Forest, took more than six years to give Mahyco Monsanto Biotech Ltd the clearance to launch Bt cotton. Now Biocon's human insulin product is still awaiting the nod though all the relevant data has been submitted several months back. Shantha Biotechnics, the first Indian company to launch a biotech drug in the country, had to face problems due to lack of clear demarcation of authority last November. The GEAC asked the Drug Controller General of India (DCGI) to inquire how Shantha Biotechnics started manufacturing Shankinase (streptokinase). Industry cites such developments as the main reason for the demand to have a clear policy framework. "While high risks and long gestation period are acting as major deterrents for the Venture Capitalists (VCs), intellectual property issues and regulatory affairs are the other major causes of concern," said Nitin Deshmukh, director general, Association of Biotechnology Led Enterprises. "An entrepreneur usually faces many difficulties to come up with a product. But he faces rather bigger difficulties when he deals with the registration of that product. Valuable time and business are lost because of this." Vivek Singhal, president, Biotech International and head of All India Biotech Association The clinical research and trials, which promises to be the next big thing, needs to be favored. Clinical Research Organizations (CROs) face delays in getting approvals for clinical trials, import and export of samples. Surinder Kher, senior vice president, iGATE Clinical Research International Pvt Ltd observed, "I think in terms of regulations and guidelines there is a clear intent from the government that they mean business. Knowing that the intent of the government is very positive, the implementation part needs to be far more rapid. The single window clearance needs to be looked into quickly. Further, the handling of biotech products by GEAC, procedures for the clearance of foreign funding of trials etc. need to be clear and fast. We also need to see how the implementation of the IPR regime happens. Because of the delays or slow implementation of the decisions, foreign companies have an element of doubt in doing business in India. We lose potential business as a country because of these hurdles. The government needs to understand the economic implications of these challenges." Export-Import Push Export of bioproducts to both developing and developed countries has been a major challenge. "We cannot enter each and every country just like that because of the patent and regulatory issues. More so in the case of developing countries as most of them are not ready with full-fledged regulatory systems and testing facilities. This is resulting in enormous delays in getting the product registered. The Indian government should come forward and through our embassies promote the industry. This way, the products will get registered a little faster and the exports can pick up," said Varaprasad Reddy, managing director, Shantha Biotechnics Pvt Ltd. It is because of poor awareness of the newer technologies that companies struggle to market their products." Anil P Kastuar, president, Lab Vantage Solutions It is not just a matter of promoting exports. Registration of a biotech company is an issue in itself. Vivek Singhal, president, Biotech International and head of All India Biotech Association pointed, "The entrepreneur usually face many difficulties to come up with a product. But he faces rather bigger difficulties when he deals with registration of that product. Valuable time and business are lost because of this." The industry feels the duty structure needs to be reviewed. The high import duties not only affect the R&D push, but also hit costs. This is discouraging the entrepreneurs to take up high end R&D and smooth running of R&D work. Navneet Trehan, director, Axygen Scientific Pvt Ltd said, "Although import duties have been slashed down for equipment used for biotech research, we are still paying around 42 percent import duty on certain products which is high compared to other Southeast Asian countries. This is affecting badly our R&D activity." At present the government only allows the import of diagnostic reagents, which have cleared the US FDA approval and meet the GMP guidelines. But in the US, for some reagents, mainly used for molecular biology research, tissue culture etc, approval is not required. Indian companies cannot import these reagents as the government of India has put restriction on these reagents. "The government should consider this as even in the US not all reagents are required to have the FDA approval. Only those reagents, which are used in diagnostics research, are required to be FDA approved," added Sunit Trivedi, general manager, BD India Pvt Ltd. "We need to work on problems relevant to our country apart from globally challenging problems. What is inhibiting us is that of leadership. There are some attempts but we have to take it up as national agenda with international participation of the knowledge base. It is a challenge and must be addressed through a massive networking biotechnological project with a clear goal." Dr V Prakash, director, Central Food Technological Research Institute, Mysore. Besides the high duty charges, the biggest challenge is logistics. Arun Prakash, managing director, Genetix, informed, "The enormous time consumed in delivering the products, storage conditions, exchange, the amount of bureaucracy involved in any transaction is also responsible for the slow pace of the industry." The other challenge before the suppliers is Earners Money Deposit (EMD). Dhiren Wagle, country manager, Bio-Rad Laboratories (India) Pvt Ltd, pointed, "The vendors have to deposit a sum of money with their customers before actually installing the equipment or instrument. They will take a lot of time to return the amount even after the successful installation. This is a matter of concern for most of the suppliers or vendors as the money is blocked in the transaction." Funding Faults The nascent biotechnology industry is anxiously looking for the funds for different aspects like expansions, R&D, day-to-day operations and promotional activities. Prof. G Padmanabhan, the distinguished biotechnologist at the Indian Institute of Science, who is working on many projects including vaccines for malaria asserted, "Funding has all along been a major problem to take up research activities. Research requires a lot of money." "Facilities have improved tremendously. But on the whole today facilities are not rate limiting but good people are." Prof. M Vijayan, associate director, Indian Institute of Science, Bangalore Venture Capitalists (VC) say they can't just offer funds. Expressing the challenges before the VCs, Alok Gupta, director, head, life sciences and biotechnology, Rabo India Finance Pvt Ltd said, "Most early stage biotechs are difficult to debt finance as their cash flows are weak, asset base is small. Also, most of these companies require funds in the range of $1-2 million, which is small for us. In short, the issues are: weak uncertain cash flows, long gestation project life, high project risk, and technology risk." Several states are talking about setting up funds. That is a welcome step. But the industry expects more at the national level. There is a demand to set up Rs 150-200 crore fund dedicated to the biotech alone. Implementation & Awareness India still follows the age-old procedures and lacks stringent norms to implement the regulations. "The implementation has become a difficult task due to lack of clear policy framework. Stiff competition, pricing and regulatory hurdles are pulling the growth of biotech products," said Dr Abhay Deshpande, general manager, Cadila Pharmaceuticals Ltd. Indian companies and R&D organizations are strangulated by the rules, which are causing enormous delays in procuring things and marching ahead. "This is partially a matter of concern because we are trying to compete internationally where time is money. Unless the things are improved, we might lose talent because they do not have the patience to wait forever," said Dr Lalji Singh, director, Center for Cellular and Molecular Biology. He added that red-tapism is a major concern. "If things are not improved, I am afraid we will lose many projects," he said. Dr SK Brahma-chari, director, Institute of Genomics and Integrative Biology concurred with Singh. He noted, "In deed, the slow movement of papers has been a crippling factor to the rate at which decisions are implemented in government organizations." Growth is the key factor for any industry. As far as clinical data management sector is concerned, Suresh Ramu, director, data management, Quintiles Spectrals observed, "The main hurdle is getting trained people. We get the trainable people. It is a time-consuming exercise to train the people. We have the manpower, well-established India brand. The laws need to be strengthened so as to respect the patent regime." "Vendors have to deposit a sum of money with their customers before actually installing the equipment or instrument. They will take a lot of time to return the amount even after the successful installation. This is a matter of concern for most of the suppliers or vendors as the money is blocked in the transaction."Dhiren Wagle, country manager, Bio-Rad Laboratories (India) Pvt Ltd Deshpande pointed out that doctors prefer to prescribe MNC brands, despite Indian companies having the USFDA approvals for their manufacturing units. This leads to the issue of awareness. Not just with the doctors but the industry as a whole. Anil P Kastuar, president, Lab Vantage Solutions Pvt Ltd, added, "It is because of poor awareness about newer technologies that companies struggle to market their products. Government can generate awareness about the new technologies through scientific platforms, where in the manufacturer and the buyer can discuss issues concerning the industry. It will help in creating a market demand." Future Call Although infrastructure for doing modern biology and biotechnology has improved substantially, over the last one decade, few areas still need the support from the government in developing the facilities. Prof. M Vijayan, associate director, Indian Institute of Science said, "Definitely the facilities have improved tremendously. But on the whole today facilities are not rate limiting but good people are." India is in a unique position in biotechnology. It has excellent human resources and some world class institutes. These need to be leveraged. Dr V Prakash director, Central Food Technological Research Institute, explained, "We also have the other extremes where some of the scientists do talk of biotechnology but hardly any infrastructure or facility is there. We have to bridge the two. We need to work on problems relevant to our country apart from globally challenging problems. What is inhibiting us is that of leadership. There are some attempts but we have to take it up as a national agenda with international participation of the knowledge base. It is a challenge and must be addressed through a massive networking biotechnological project with a clear goal. " "While high risk involved and long gestation period are acting as major deterrent for VCs, intellectual property issues and regulatory affairs are also major causes of concern." Nitin Deshmukh, director general, Association of Biotechnology Led Enterprises. Biotechnology is viewed as the next big economic opportunity for India. The fact is that biotechnology is capital intensive, research intensive and IP intensive with inherently long gestational time lines for product commercialization. As the industry is still in its infancy and many companies are still in the development stage, India could be well positioned to develop its biotech manufacturing capabilities and engineer growth provided it gets proper and regular support from the government in the form of incentives, cut in duties, seed funding etc. As noted by Dr Maharaj Krishan Bhan, the government should focus carefully on the need to take the benefits of science to the Indian people. It could be an efficient health insurance scheme promoted more aggressively and balanced price level of biotech products, a crucial aspect relevant to the masses. Just providing support won't help. It has to implement and enforce the legislations. Implementation of the patent regime is the testing time for the Indian companies. Steps in the right direction will drive India to greater heights. The next two years will be a tough period as far as Indian companies are concerned. Narayan Kulkarni with inputs from Faiz Askari in New Delhi, Rolly Dureha in Bangalore. ]]> <![CDATA[The US biosciences sector employed 8.85 lakh people in 2003]]> https://biospectrumindia.com/news/95/2084/the-us-biosciences-sector-employed-8-85-lakh-people-in-2003.html https://biospectrumindia.com/news/95/2084/the-us-biosciences-sector-employed-8-85-lakh-people-in-2003.html Tue, 13 Jul 2004 17:10:00 +0530 AMERICAS The US biosciences sector employed 8.85 lakh people in 2003 According to a new study by the Battelle Memorial Institute and the State Science and Technology Institute (SSTI) for the Biotechnology Industry Organization (BIO), states in the US working to attract bioscience companies are learning that success means specializing in specific sub-sectors. The study was a comprehensive analysis done to quantify the scope and impact of bioscience employment in 50 states. According to the report, in 2004, 40 states have specifically targeted biosciences for development, though all the 50 states have economic development initiatives available to assist bioscience companies. Investments have grown by as much as $500 million in Florida and experimental approaches, such as tax credits to encourage investment in private venture capital funds, have increased significantly. There are over 8.85 lakh people employed in the biosciences sector in the US. A large number of this group works in the areas of medical devices and equipment. This segment accounts for 37 percent share of the total employment in the bioscience sector. In 2003, bioscience workers were paid at least $26,600 more than the overall national average private sector annual wage. Bioscience development is spread across manufacturing, services and research and is not limited merely to medicine or agriculture. States and regions, promoting bioscience development, are focusing on the activities best suited for the area. For example, North Dakota is focusing on bioprocessing in value-added agriculture, while Missouri is seeking to become a leading center in plant and animal health. States such as Colorado, Massachusetts, Minnesota and Utah are working in the area of medical devices, while other states are devoting their attentions to research and testing. Partly as a result of economic development programs, 15 states have at least five percent employment in at least one bioscience sector, and 24 states have at least three percent employment in one or more sub-sectors, according to the report. Twelve states-California, Illinois, Indiana, Iowa, Massachusetts, Minnesota, New Jersey, North Carolina, Pennsylvania, South Carolina, Tennessee and Virginia-have both large employment bases in the biosciences and are specialized in at least one industry sub-sector. Factors that appear to influence a state's ability to grow bioscience employment include the degree of involvement by research institutions, available capital, access to facilities and equipment, a stable and supportive tax and regulatory environment and a long-term perspective. That long-term perspective is reflected in every state's renewed emphasis on science and math education, including programs throughout the K-12 school years aimed at preparing students for bioscience careers. Recent initiatives include Connecticut's creation of a $5 million BioSeed Fund, which invests up to $500,000 in early-stage companies and Kentucky's $5 million Natural Product Fund. North Carolina created a Life Sciences Industry Revenue Bonding Authority to finance biomanufacturing equipment and lab fit-outs. Some state programs already have a record of success in assisting bioscience companies. Maryland's Industrial Partnership Program provided some initial support for development of the manufacturing facility for MedImmune's $1.6 billion Synagis, which prevents a respiratory disease in infants, and Martek Bioscience's additive for infant formulas, which helped the company generate $114 million in revenue in 2003. Source: www.bio.org Brazil set to become world's main biofuel supplier Brazil could become the world's largest supplier of biofuel within a decade according to the International Energy Agency (IEA), by which time 10 percent of the world's petrol and three percent of diesel will be biofuel admixtures. The IEA furthermore sees 60-70 percent of the biofuel replacements being made up of ethanol. Brazilian ethanol, made from sugarcane, is twice as cheap to produce compared to the US ethanol, which is made from corn. This means Brazil is already facing trade barriers to the US market, where every cubic meter, which can be sold at $150, has another $130 added. "There's no fair competition," said Antonio Padua, the director of the Sao Paulo Sugar and Ethanol Association (Unica). The US Senate justifies its trade barrier by saying it is trying to encourage a nascent alternative energy source. "This market (the US) can be completely supplied by corn ethanol but even so prospects are excellent for Brazil, as well as for other cane growers such as China and Thailand," said Padua. Padua forecasts that in 10 years Brazil's ethanol exports could raise to 10 billion liters annually from the 1 billion liters of 2003. Source: www.aebrazil.com Third generation genome project initiated Dr Michael Rudnicki Dr Michael Rudnicki, director, stem cell center and senior scientist at the Ottawa Health Research Institute (OHRI), Canada, has announced the formation of an international consortium, International Regulome Consortium, to elaborate the regulatory factors that control gene expression from the human genome. This consortium aims to map the regulatory networks that control gene expression-the Regulome. "Thanks to this collaboration, we will eventually possess the complete circuit board of the genetic processes that regulate the formation and function of the over 200 cell types that make up the human body," said Dr Rudnicki. Top researchers such as Dr Allan Bradley of the Sanger Institute in Hinxton, UK; Dr Bing Lim, senior group leader, Genome Institute of Singapore; and Dr Irwin Davidson, of the Institut de GÃ©nÃ©tique et de Biologie MolÃ©culaire et Cellulaire, CNRS/INSERM/ULP, CollÃ¨ge de France, have pledged their support. Besides, Dr Janet Rossant of the Samuel Lunenfeld Research Institute and Dr Jack Greenblatt of the University of Toronto will also support this endeavor. This is the third generation genomics project. It may be recalled that in 1990, the international Human Genome Project was launched that sought to identify all of the approximately 30,000 genes in human DNA. A working draft of the entire human genome sequence was announced in June 2000, with a more complete sequence published in 2003. It was immediately hailed as one of the most important breakthroughs in science. This discovery eventually led to a second generation of research to identify all the proteins encoded by the genes with a view to understand their role in normal tissue and the protein alterations in disease states. The International Regulome Consortium proposes a third generation genome project that will delineate how genes are switched on and off to regulate the amount of protein made. The project will define the genetic circuit board that controls the expression of genes in cells during the formation of all tissues and organs in the body. According to Dr Rudnicki the implications of such a profound understanding would be tremendous leading to groundbreaking advances in the fight against many complex diseases. Source: www.ohri.ca EUROPE EU Commission approves biotech sweet corn The EU Commission hasapproved Genetically Modified (GM) sweet corn (Bt-11) for use as food in the nations under the European Union (EU). This is the first GM food product to be approved in Europe since 1998. This sweet corn is genetically modified to protect itself from corn borer insect damage. "The Commission's decision to finally approve this biotech sweet corn is a welcome move and a positive signal. This decision is the first step by the EU to move ahead with the approval process for new biotech products under the EU's new regulatory regime for the authorization of GM products," said Johan Vanhemelrijck, secretary general, EuropaBio, the European association for bioindustries. "But, it is only the first step on the road to unblocking the approval process. We will have to wait to see whether further approvals, including those for cultivation, are forthcoming." The biotech sweet corn is already approved for food use in Argentina, Australia, Canada, China, Japan, Korea, New Zealand, the Philippines, Russia, South Africa, Switzerland, Uruguay and the US. It was first approved in the US and Canada in 1996. Source: www.europabio.org BIA hails Government response to "Bioscience 2015" The BioIndustry Association (BIA) welcomed the publication of the Government's response to the Bioscience Innovation and Growth Team report, "Bioscience 2015" in the UK. "Several positive steps have been made towards addressing the recommendations in Bioscience 2015. The BIA has warmly welcomed the announcement in the Budget of additional funding for NHS R&D. This is a great start, but additional funding will be required to ensure the success of this initiative. The establishment of the UK Clinical Research Collaboration is also an important step in improving the UK's clinical research infrastructure, although urgent issues such as the length of the drug approval process and cost-effectiveness issues must be addressed if the UK is to succeed," said Aisling Burnand, Chief Executive, BIA. Burnand pointed out that it is essential that the UK gets the funding environment right as the European bioscience industry faces a near-term funding crisis and it is at a disadvantage relative to the US. "It is disappointing that the Government's response does not yet fully support any of the report's key recommendations on funding. The report called for several measures to improve the liquidity of emerging bioscience companies, such as changes to pre-emption rights and extending the scope of the Corporate Venturing Scheme and R&D tax credits. Government has a significant role to play in helping create a funding environment in which the UK sector can thrive. It is time to act now, before it is too late to catch up with international competitors," added Aisling Burnand. It was also essential to ensure a secure environment for the medical research sector. The BIA and partner organizations have been strongly urging the Government for some time to introduce a new single piece of legislation that will definitively deal with the ongoing violence, home visits and intimidation that continues to be faced daily by those involved in medical research using animals. "Previous attempts to amend existing legislation have provided brief respite to the problem. We urge the Government to tackle this comprehensively to prevent R&D being driven abroad," said Aisling Burnand. Source: www.bioindustry.org ASIA-PACIFIC National Taiwan University plans biobank The National Taiwan University (NTU) Hospital plans to launch Taiwan's first "biobank" as a means of boosting medical research and treatment, but the project faces problems of funding and a lack of widespread participation, doctors said. "A biobank is a place to store samples, an information-sharing center. It is absolutely needed," said Chang Chi-jen, an NTU Bio-informatics Lab professor. According to surgeon Yang Ching-yao the NTU Angiogenesis Research Center and the NTU Hospital Department of Surgery currently hold just over 300 samples, consisting of about 150 specimens from liver cancer patients and 200 from stomach cancer patients. "In the past, when doctors or researchers needed to access certain types of data, it was not a problem of time; the problem was that you couldn't even find the data. This new system [the biobank] would make searching data much more efficient," said Chen Chiung-nien of the NTU Hospital Department of Surgery. The biobank is the brainchild of NTU College of Medicine professor Hsieh Fon-jou. "Infrastructure is tomorrow's medicine. The first priority of Taiwanese scientific development is infrastructure," Hsieh said, explaining that the NTU biobank could serve as a common language between different medical institutions and allow for data fusion. "We could continue to build upon the biobank indefinitely. [Its scope] could be as small as one hospital department or as large as all hospitals," Hsieh said. However, doctors admitted that as of yet, no other hospitals were using the biobank software interface that had been chosen by the NTU. Source: www.taipeitimes.com ]]> <![CDATA[Pall Corp to launch disposable depth filter capsule for biopharma sector]]> https://biospectrumindia.com/news/95/2737/pall-corp-to-launch-disposable-depth-filter-capsule-for-biopharma-sector.html https://biospectrumindia.com/news/95/2737/pall-corp-to-launch-disposable-depth-filter-capsule-for-biopharma-sector.html Thu, 10 Jun 2004 16:15:00 +0530 Pall Corp to launch disposable depth filter capsule for biopharma sector To meet the growing need of single use technologies in biopharma production, Pall Corporation is introducing the first disposable depth filter capsule for pilot to large-scale biotech drug manufacturing. The SUPRA clean depth filter capsule combines the performance, value and safety of Pall's depth filters into a single use capsule that saves time, labor and operating costs. The depth filters are an invaluable tool for efficient and economical clarification and prefiltration of biological solutions used to manufacture recombinant protein-based drugs, vaccines and blood products. The capsule will play a critical role in drug production as biopharmaceutical companies increasingly adopt disposable processing solutions to reduce validation bottlenecks, contamination risks and cost, according to the company's release. "The SUPRA clean capsule is the latest addition to our growing portfolio of single use solutions for biopharmaceutical manufacturing and will further drive our business through recurring sales," said Ed Hoare, president, Pall BioPharmaceuticals. "Disposable products help the industry bring new drugs to market faster, prevent costly setbacks in commercial production and also reduce capital costs in new plant designs." According to the official release, the SUPRA clean depth filter capsule gives manufacturers a host of benefits that only a single use system can provide. It eliminates the costs associated with the Cleaning-in-Place (CIP) cycle. This includes cleaning of the housing, which can cause production bottlenecks and add cost, and cleaning validation, which can delay commercialization of new drugs. Its design increases safety by significantly decreasing operator exposure to the product. The capsule design also provides a lower hold-up volume than standard module housings, allowing for greater recovery of the product. The housing, which functions primarily as a means of secondary containment, is cleanable, improves sealing and promotes uniform flow distribution. It can be used with Pall's full range of depth filter modules. Praj begins new fiscal on promising note Pune-based Praj Industries Ltd has begun its new financial year on a promising note with six orders for ethanol fuel plants in the domestic market and is expecting major breakthroughs soon in international markets. Recently Praj commissioned a 150,000-liter per day ethanol fuel plant near Mumbai. This plant is said to be among the largest plants in India. It has also received three orders from Gujarat for Greenfield ethanol fuel plants. Praj has already commissioned one plant and another is under execution in the state. Pramod Chaudhari, chairman and managing director, Praj said, "We have consolidated not only on the domestic front, but with the recent orders from the South American market for ethanol fuel plants, we are also establishing ourselves as technology leaders in markets dominated by developed countries." Praj has finalized contracts for two Greenfield ethanol fuel plants in Colombia. These orders, worth over $15 million were won against formidable competition from companies in Brazil and Europe. Praj was also awarded a contract for a large sized ethanol plant based on molecular sieve dehydration technology for installation in Central America. For the year ended March 31, 2004, Praj's sales grew by over 20 percent over previous fiscal and the PBT by over 150 percent. With this, income from operations stands at Rs109.50 crore (Rs 88.10 crore), profit before tax at Rs 11.17 crore (Rs 4.74 crore) and PAT at Rs 8.34 crore (Rs 2.42 crore) for the year ended March 2004. With the consolidation of its financial and market performance, Praj is focusing on its operations to ramp up for healthy growth. Praj has recently inducted two new directors on its Board. Rakesh Jhunjhunwala joined the Board in March 2004. Ajit Lele, who has several years of experience in the engineering industry joined as the joint managing director in April this year, in addition to Shashank Inamdar joint managing director. Inamdar and Lele will assist Chaudhari, CMD, to gear up to take on new challenges in the international market where the company foresees itself exploring new markets more aggressively. MeasureTest Corp organizes seminar in June MeasureTest Corporation is organizing a seminar on TOC measurement and particle counting of interest to pharmaceutical and allied industries (clean room contractors, purified water manufacturers/users). The seminar will be held at Hyderabad, Bangalore and Goa respectively. Topics covered during the seminar include basics of airborne particle counting, impact of new international cleanroom standards on pharma industry, HEPA filter design, leak testing and on-line total organic carbon measurement of pharmaceutical waters. Michael Retzik, director TOC Applications, Hach Ultra Analytics USA will be the keynote speaker. A similar seminar was held in Mumbai in March. Alfa Laval acquires Biokinetics Alfa Laval has acquired Biokinetics, the life science division of the Kinetics Group Inc. in the US. Biokinetics is the technology player in the engineering and manufacturing of turnkey process systems for the biotech and pharma industries. The company's main products focus primarily on mammalian cell cultures and include bioreactor modules, cell harvesting modules, purification modules and biodeactivation modules. The acquisition will allow Alfa Laval to combine Biokinetics resources with Alfa Laval's global presence and move into the European and Asian markets. The combined offering will include process design, modules for unit operations and key components such as high-speed separators, compact heat exchangers, membranes, fluid handling equipment and parts and service. Biokinetics was part of the US Filter Corporation until August 2000 when it was taken private in an investor-led buyout. Biokinetics, which has approximately 400 employees, is headquartered in Philadelphia, PA. The company also has facilities in North Carolina, California, Puerto Rico and Toronto. Alfa Laval, with 920 employees in the US and 9350 worldwide has an office in India. Thermo partners with Block Scientific Thermo Electron Corporation and Block Scientific Inc. have joined together to offer premium quality ALKO Clinical Consumables and equipment for a total lab solution. The Lab Solution packages include instrumentation, consumables, parts and service for a broad range of Blood Gas, Electrolyte (ISE) and Chemistry (ISE) analyzers. The analyzers supported by both companies include those manufactured by Bayer (Chiron), Beckman, IL, Olympus, Radiometer, Roche AVL and Roche/Hitachi. Thermo Electron and Block Scientific will work with each laboratory to suit specific product and instrumentation needs. According to the company's release, ALKO Blood Gas and Electrolyte products from Thermo Electron that helps life science, laboratory, and industrial customers are manufactured under FDA quality system regulations. The company's line of products includes calibrators, accessory solutions, electrodes, accessories and quality controls for use in over 130 clinical instruments. Thermo Electron also offers cytology/histology products of Lerner Laboratories and HPLC products of Chromsystems. SAS India offers data management solutions to CROs Apart from providing solutions to the pharmaceutical industry, SAS India offers data management and statistical analysis solutions to the Clinical Research Organizations (CROs) in India. The pharmaceutical/life sciences sector has been a key focus vertical for SAS India and accounted for 15 percent of the company's revenues in 2003, said George Varghese, Head - Marketing, SAS India Pvt. Ltd. Varghese informed BioSpectrum that, "SAS Solutions adhere to regulatory compliances, which are set by US Food and Drug Association. Having this unique value proposition, SAS Solutions not only help CROs in India to meet the compliance requirements but also play a significant role in enhancing their clinical research processes." SAS India offers solutions like SAS scientific discovery solutions, SAS drug development, SAS drug discovery, SAS process intelligence, SAS patent portfolio management, customer relationship management, performance management for healthcare, web analytics service and SAS intellivisor to the life sciences/pharmaceutical industry. Replying to a question, he said that SAS India is offering services to most of the CROs in India. SAS offers unique business intelligence solutions that span the entire value chain and not just isolated components of it. Its clientele include companies like Wellquest, Lambda Therapeutic, Synchron Research, Diagno-search, Asian Clinical Trials, Quintiles, Lotus Labs, Vimta Laboratories, GVK Bioscience, Therapeutic Drug Monitoring Lab, Accutest Research Laboratories, to name a few. SAS has been in India since 1997 and currently has two whoxlly owned subsidiaries in the country â€“ SAS India and SAS Global Services (SGS). SAS India operations are headquartered in Mumbai with regional offices in Bangalore and New Delhi. SAS Global Services (SGS) is a key resource arm for the global SAS community and focuses on R&D and industry intelligence solutions development and is headquartered at Pune. Research and development initiatives at SGS are strategically focused to address the Java and web development of the forthcoming SAS solutions. SAS® industry intelligence solutions provide a framework and foundation for addressing critical business areas to enable quick implementation of effective business strategies. Built on 26 years of market leadership, these solutions integrate SAS' leading analytical and data management technology with extensive industry experience. PerkinElmer, Lab India launch joint Indian operation PerkinElmer Inc, a drug discovery, life science research and analytical solutions provider along with Lab India Instruments Pvt. Ltd, India's key lab service and marketing organization, jointly announced the launch of PerkinElmer India Pvt. Ltd, a direct sales, service and marketing operation targeting India's thriving life science and analytical instrumentation markets. The partnership provides a strong growth opportunity for PerkinElmer and underscores the company's commitment to customers in the region. PerkinElmer will hold a majority interest in the joint venture, which will be headquartered in Thane, with demo facilities and sales offices in Bangalore, Baroda, Chennai, Hyderabad, Kolkatta, Lucknow, Mumbai, New Delhi, Pune and Thane. PerkinElmer India will employ 180 people dedicated to direct sales, service, technical support and administration. "India represents a key growth market for a number of PerkinElmer businesses including biopharma, environmental and chemical and genetic screening," said Peter Coggins, president, PerkinElmer Life and Analytical Sciences. "We are pleased to be working with Lab India to bring the full range of our life and analytical sciences product and service portfolio to India's rapidly expanding community of scientists and researchers." "This joint venture is the natural extension of a relationship that has been successful for more than 23 years," said Shriram Bhalerao, managing director of Lab India. "PerkinElmer India will harness the combined strengths of both companies to drive the growth opportunitiesâ€”Lab India's superior knowledge, service and support of the India market and PerkinElmer's operational excellence and technology expertise." Imperial Bio-Medic to set an application support facility soon Imperial Bio-Medic (P) Ltd., a fast growing supplier company offering a broad portfolio of research products and services to the biotech industry, is marching towards a new milestone by setting up an application support facility soon. The facility will provide support for various kinds of genetic and molecular biology applications. At the facility personnel will be trained for performing different applications on real time PCR system from Stratagene (Imperial Bio-Medic is the exclusive distributor for Stratagene in India) and professionals will look after the entire assay designing and optimization module. Highly educated and trained molecular biologists will be hired for troubleshooting related to primer/probe design, PCR and cloning strategies. "We strongly feel that above facility will strengthen the relationships with our valued customers and we shall be able to serve them in a better way with high quality products," said SK Gupta, managing director, Imperial Bio-Medic. The company represents more than 40 international companies in the Indian market including Bethyl, BioEnzyme, Biogene, CBS Electrophoresis, etc. Sartorius focusing on profitable growth Sartorius is on a consolidation drive and its financial results of the first quarter of 2004 indicate positive trends for sales revenue and earnings. In the 2004 annual shareholders' meeting of Sartorius, Dr Joachim Kreuzburg, spokesman of the executive board and group CEO, described the year 2003 as that of consolidation that was strongly characterized by the restructuring measures implemented. (In 2003, the company earned sales revenue of 442.3 million euros.) "Now we can concentrate on profitable growth," stated Kreuzburg. "The focus of our work is now on innovation and selling, marketing and distribution. We will be developing a number of innovative products and be launching these on the markets. Beyond this, we will also keep an eye on the cost side and work on improving our cost structures." The Goettingen-based company founded in 1870 currently employs about 3,660 persons. Its biotech segment focuses on filtration and separation products, bioreactors and proteomics. Sartorius has its own production facilities in Europe, Asia and America as well as sales subsidiaries and local commercial agencies in more than 110 countries. ]]> <![CDATA[Drugs with LMOs to escape GEAC dragnet]]> https://biospectrumindia.com/news/95/1684/drugs-with-lmos-to-escape-geac-dragnet.html https://biospectrumindia.com/news/95/1684/drugs-with-lmos-to-escape-geac-dragnet.html Thu, 10 Jun 2004 15:47:00 +0530 Drugs with LMOs to escape GEAC dragnet The Mashelkar task force on recombinant drugs has got off to a flying start with the biotech industry leaders getting a chance to present their case to him in person in the Capital in mid-May. Many of the regulatory bottlenecks, repeatedly highlighted by BioSpectrum in the past 12 months, may be removed faster than expected. This is the message coming out of the first meeting of the Mashelkar Task Force. A Special Report Makers of recombinant biotherapeutics can breathe easy. Soon they may not have to approach the Genetic Engineering Approval Committee (GEAC) of the Ministry of Environment and Forests (MoEF) for approval of such products. It may remove one layer from the complex regulatory system that exists in India. In fact, during the meeting it was revealed that GEAC might have taken upon itself the task of regulating recombinant drugs by sheer mistake. GEAC officials argued that they had taken up the job on the basis of a set of guidelines issued by the Department of Biotechnology (DBT) many years ago, which had apparently assigned this task to GEAC. Heat over Imports ABLE President Kiran Mazumdar-Shaw told the Task Force that the country could tap a huge potential that exists in the opportunity to conduct contract research and manufacturing as an outsourced activity for foreign clients. This opportunity was lost due to the cumbersome procedures involved in getting the permission for import of Genetically Modified Organisms (GMOs) used in these products. Here, importers have to get the approvals from GEAC, clearance under the Plant Quarantine Act for GMOs. While this stymies the domestic industry, importers of various recombinant drugs have a relatively smooth passage into the country. She said the government unfairly permitted marketing of imported recombinant product without insisting on clinical trials. On the other hand, Indian manufacturers of the same products had to go through elaborate clinical trials. All countries have a stringent regulatory norm for recombinant drugs. Why should India be so lenient, she demanded.GEAC secretary DD Verma retorted that this was because manufacturing of recombinant drugs had much wider implications for the country in terms of environmental impact. Also, the marketing of imported drugs were permitted on the basis that the drug was already in the marketplace in the country of origin, which indicated that sufficient data existed to establish its safety in humans. DBT secretary, Dr MK Bhan, admitted that a typed attachment to the RCGM (Review Committee on Genetic Manipulation) many years ago might have caused this misunderstanding. The new co-chairman of GEAC, Dr Asim Ghosh, too admitted that the agency had no role to play in the evaluation of clinical trials of recombinant drugs. The MoEF secretary, Dr Prodipto Ghosh, informed in the first meeting of Mashelkar Task Force in New Delhi on May 12 that GEAC would confine its role to approving biotech products, which are in the form of Living Modified Organisms (LMOs). What is heartening to the industry is that Dr Ghosh has clearly proposed that GEAC would exclude itself from product approvals pertaining to products emanating from LMOs but LMOs themselves. Welcoming Dr Ghosh's proposal, the president of Association of Biotechnology-Led Enterprises (ABLE), Kiran Mazumdar-Shaw said that it was equally important for GEAC to ensure that its role was limited to "inactivating" LMOs before they are released into the environment. She also suggested that regulators need not differentiate between recombinant DNA (r-DNA) drugs and conventional drugs in conducting pre-clinical and clinical trials. The safety and efficacy parameters for both the type of drugs are the same. There was just a question related to whether r-DNA drugs should undergo only the "Bio-equivalence" measurements or whether they too should be subjected to Phase III clinical trials. While this may be good news, Dr Ghosh has redefined the priorities of GEAC in his presentation to the task force. He reiterated that GEAC would be the agency responsible for evaluating the environmental impact caused by LMOs, assess environmental risks and estimate the benefits that are likely to accrue to the society. Another crucial remark of Dr Ghosh was that GEAC would approve products only if the environmental impact realizes a net benefit to society. This may become a contentious issue especially in the bio agriculture sector. Because, the only bioagri product approved so far, the Bt cotton has generated a lot of controversies with both the supporters and opponents offering differing views on its benefits. The removal of LMO-based products from GEAC's purview had other supporters too. Director-general of Indian Council of Medical Research (ICMR) Dr NK Ganguly informed the task force that non-LMO based recombinant products could be approved by the Drug Controller General of India (DCGI). Dr Ganguly also informed that DCGI and ICMR have acquired the expertise to regulate recombinant therapeutics. The government is setting up a testing lab at a cost of Rs 3.6 crore at the National Institute of Biologicals (NIB) for these products. A special committee has also been set up under DCGI to handle recombinant drug products. He clearly stressed the fact that GEAC had no role to play in the drug approval process and further Schedule Y of Drugs and Cosmetics Act had been modified to reflect recombinant products. The Drug Controller Dr Ashwini Kumar told the Task Force that it was essential to treat recombinant drugs similar to other drugs and there was no requirement to evaluate these products on the lines of genetically modified crops and LMO-based end products. He reasoned that the two other regulatory agenciesâ€”the Institutional Biosafety Committee and the Review Committee on Genetic Manipulation (RCGM) were already doing the job of evaluating the safety aspects of the use of LMOs and environmental contamination of these in the drug manufacturing processes. Another key industry supporter was DBT secretary Dr MK Bhan. He emphasized the need to set up a single regulatory agency to handle recombinant drugs. Dr Bhan indicated that there was a need to set up a comprehensive, extensive and integrated regulatory agency that had a high level of expertise to evaluate, approve and regulate recombinant drugs in a dedicated manner. This was the system followed by Federal Drug Agency (FDA) of the US. Some highlights of various presentations at the Task Force Dr MK Bhan The DBT secretary said that the biotech industry did not have comprehensive documentation to reflect a professional level of product development evaluation. He suggested that it should be made mandatory to encourage industries to have a "Product Development Plan". Dr Mashelkar's Response: This would be an ideal model but would require an evolutionary process to get there as it might require time and a change in mindset. Kiran Mazumdar-Shaw, President, ABLE and CMD, Biocon, Bangalore: The ABLE president highlighted five key problems facing the industry in this area. These are: â€¢ Multiple regulators â€¢ Multiple ministries â€¢ Lack of coordination between regulators â€¢ Overlapping and duplication of responsibilities of these regulators â€¢ Lack of linear progression in the approval process She wanted a clear flow-chart for the regulatory process. She also stressed the importance to have clear time lines for product approvals. Mahima Datla, Nominee of FICCI and VP, Biological E, Hyderabad: She supported Dr Bhan's suggestion and said the industry was looking forward to a system that simplified the regulatory approval procedure by having a single licensing authority to issue all licenses and permissions pertaining to recombinant drugs. There was also no need to reinvent the wheel in terms of evaluation procedures as there was exhaustive information available from the World Health Organization (WHO), US FDA and other international regulatory agencies that are much ahead in terms of regulatory procedures for recombinant drugs. Dr Sandhya Tewari and DB Patankar, CII: CII representatives felt that a biotech drug was essentially a drug and therefore the clinical trials should be supervised by the DCGI. The RCGM should be responsible for research and manufacturing. It was also important to clearly demarcate the roles and responsibilities of each regulatory agency to ensure that there was no overlap or duplication. Dr Tewari said it was critical to ensure that only experts evaluated the drug applications. Professional experts should be part of the evaluation committees. CII presented a comprehensive paper delineating the various roles of regulatory agencies. Overall, the first meeting of the Task Force had been useful for the biotech industry. In fact, Dr Mashelkar indicated that the meeting provided valuable inputs on the role of GEAC in regulating LMOs. The industry is hopeful that Dr Mashelkar's reports will herald a new era in the Indian biotech sector. The Task Force chairman, Dr RA Mashelkar, director-general, CSIR, has asked Dr Bhan to make a separate presentation on the need for a "Biotech Regulatory Authority." The task force is expected to submit the report by July-end. Dr Mashelkar had indicated that he might hold another meeting with industry leaders and also consult at least 50 experts before submitting his report. N Suresh The tasks before the Task Force The tasks before the Task Force The Genetic Engineering Approval Committee (GEAC), which is a key biotech regulatory agency, is part of the Ministry of Environment and Forests (MoEF). MoEF secretary, Dr Prodipto Ghosh, had made a comprehensive presentation on the current and desired regulatory framework for recombinant therapeutics. He also acknowledged the need to achieve a streamlined, hassle-free environment for regulatory approvals. His suggestions to make this happen include: â€¢ To identify bottlenecks and constraints â€¢ To recommend transparent and streamlined procedures for regulatory approvals â€¢ To identify the perceived problems faced by the biotech industry â€¢ To address issues pertaining to the uncertainty of timelines in the regulatory approval process â€¢ To understand the existing regulatory rules for product and process approvals â€¢ To clarify the decision making process in the approval procedure by clearly demarcating the responsibilities of the various regulatory bodies involved â€¢ To address the complaints received from industry with respect to the infrequency of GEAC meetings â€¢ To address suggestions made by industry to represent themselves at GEAC meetings â€¢ To address complaints received from industry with respect to GEAC reacting to third party/media reports without verifying the facts of the allegations Many of the issues have recently been addressed by the regulator. He outlined these proactive measures: â€¢ GEAC has eliminated the unpredictability of its meetings by meeting on the second Wednesday of every month. This has become effective since January 2004 â€¢ GEAC has addressed the transparency issue by posting all the decisions taken at GEAC meetings on its website â€¢ GEAC has started inviting industry representatives to be present at GEAC meetings to clarify any issues that may raised at these meetings pertaining to applications in order to eliminate delays â€¢ A Task Force on agri biotech products under the chairmanship of Prof. MS Swaminathan was set up and the task force has submitted its recommendations for regulatory reforms in this sector. ]]> <![CDATA[Kapil Sibal is Minister for Science and Technology]]> https://biospectrumindia.com/news/95/1240/kapil-sibal-is-minister-for-science-and-technology.html https://biospectrumindia.com/news/95/1240/kapil-sibal-is-minister-for-science-and-technology.html Thu, 10 Jun 2004 15:28:00 +0530 Kapil Sibal is Minister for Science and Technology Kapil Sibal Kapil Sibal, a noted lawyer and additional solicitor general of India between December 1989 and December 1990, is the new Cabinet Minister for Science and Technology. He sees biotechnology as the next big opportunity for India. "Biotechnology can become the next booming sector. Regulations on this sector should be liberalized. With our scientific base and cheap manufacturing set-ups, we can do brilliantly with foreign collaboration," Sibal said. He also wants to focus on bringing FDI into the biotechnology sector. Sibal is one of India's brilliant trial lawyers. After graduating from St Stephen's College and studying law at Harvard Law School, Sibal first entered the Parliament in July 1998 when he was elected to the Rajya Sabha to represent Bihar. An active member of the bar associations, Sibal has also been the president of the Supreme Court Bar Association for three terms. He was the Congress parliamentary party secretary for the two-year term from August 2000 and a member of the Joint Parliamentary Committee on stock market scam set up in April 2001, besides being on board of House committees on business advisory and home affairs. Mahendra Dashora Mahendra Dashora heads AccuRex Biomedical Mahendra J Dashora now looks after the entire operations of AccuRex Biomedical as a managing director of the company. Dashora took charge as the managing director with the demise of AJ Thakur. Earlier he was working as a technical director of the company. His 20 years of work experience as an entrepreneur and a biochemist has made AccuRex Biomedical a Rs 10 crore company with a vast user base for indigenous products. Dashora joined research in the field of neurotransmitters after completing his masters in biochemistry from MS University, Baroda. But soon he realized that India is in need of people who can indigenously manufacture clinical chemistry reagents for easy procurement with better economy. Initially, in 1985, he set up a partnership organization to launch routine clinical chemistry reagents for semi-automated analyzer based pathology laboratories. Then in 1994 the organization turned into a private limited company and expanded its market, networking across the Indian subcontinent. Priya joins SIRO Priya Pawar Priya Pawar has joined SIRO Clinpharm Pvt Ltd as manager, business development. At SIRO she will be responsible for business development in domestic and international markets, marketing promotions and client interfacing. She joined SIRO in the place of Dr Mohanish Anand who has left SIRO to join Pfizer. Before joining SIRO, Pawar was responsible for business development in SRL Ranbaxy's Clinical Research Services division. During her tenure of a little over four years, she handled responsibilities ranging from developing the domestic and international markets, exploring new business avenues to strategic planning. She has masters in management with specialization in marketing from Jamnalal Bajaj Institute of Management Studies with BSc in chemistry from Mumbai University. Indian scientists present papers at ISBA symposium The 13th International Symposium on the "Biology of Actinomycetes" (ISBA) was held in Melbourne, Australia, followed by a two-day workshop organized by the World Federation of Culture Collections on Commercial Applications. During the seminar Indian scientists made presentations too. Dr Rup Lal's group made a presentation on genetics/taxonomy of A. mediterranei; Dr Srivastava and KK Mishra from Banaras Hindu University presented on Streptomyces causing potato scab disease; and Dr BN Ganguli, chair professor, Agharkar Research Institute, Pune, talked on a new thrombolytic enzyme "actinokinase" from Streptomyces megasporus during the symposium. Dr Shinji Miyadoh of Japan was honored with a lifetime achievement award. Dr Rup Lal is from University of Delhi and has been awarded biotechnology overseas associateship for the year 1999-2000 by DBT and has also been a member of Review Committee on Genetic Manipulation, DBT. Dr BN Ganguli has been in the governing body of Interactive School of Health Affairs and a Western region team leader of the National Microbial Resources Project of DBT. ]]> <![CDATA[Thumbs up! PUMBA]]> https://biospectrumindia.com/news/95/5833/thumbs-up-pumba.html https://biospectrumindia.com/news/95/5833/thumbs-up-pumba.html Thu, 10 Jun 2004 15:02:00 +0530 Thumbs up! PUMBA The first batch of MBA biotechnology has graduated from Pune University. Most of the students have received job offers, some have joined, some are waiting while some are planning to take up PhD. It is celebration time at major management institutes. The scenario is no different at the Department of Management Sciences (PUMBA), University of Pune where the first batch of students just completed the management course in biotechnology. The final exams ended on April 30 and the students are still awaiting their results. But lady luck has already opened doors with offers from different life sciences/biotechnology/biopharmaceutical companies. Already about 50 percent of the students have got offers and some have even joined jobs. Companies from across the country with a focus on pharma, services, bioinformatics, suppliers or agriculture segment have been participating in the placement program at PUMBA to take students. Companies like Wockhardt, pioneer in manufacturing recombinant biotech drugs, Serum Institute of India, a leading vaccine manufacturer, Frost & Sullivan, a global biotech consultant, RPG Life Sciences, Sanmar, Advanced Biochemicals, Trans Search, a flagship company of Sanmar group, Hysel, Quintiles Spectra and Synergy Net have participated in campus interviews. Most of the companies have made offers in the range of Rs 2.5- 3.5 lakh gross per annum. RPG Life Sciences has made the highest offer of Rs 3.8 lakh. Wockhardt has made as many as eight offers while Serum, RPG Life Sciences made two offers each. However, Smita S Singhania, course co-ordinator (MBA-biotechnology) observed that we were not able make it to all the top biotechnology companies like Biocon. This is mainly because the companies recruit students during the last quarter of the year, which the students find difficult to wait for. Commenting on package deals Singhania said, "We are looking at the gross a candidate can get and not the cost to the company (CTC). Usually the company package to a candidate includes air fair, hotel accommodation, laptop and other expenses. So the package will be on a higher side. We have asked the companies to provide the gross figure the students will get at the end." About 10 percent of the students were interested in becoming entrepreneurs at the start of the course. But now looking at the companies and their package deals they have changed their mind. However a couple of students are interested in pursuing higher education. The placement process started about two months ago. It is expected to continue till the end of June. The enthusiasm shown by the companies reflects the industry's need for fresh talent in the marketing space for biotechnology. Reaction to the program KA Narayan, president corporate, human resources and legal, Wockhardt Ltd that has made as many as eight offers and looking at a few more said, "Its great to know the University of Pune is offering courses in biotechnology from department of management sciences. Actually the basic understanding of biotechnology will support the marketing activities of a company like Wockhardt, which has biotech products. It's difficult for the regular medical representatives to convince the doctors to use the new therapeutic drugs. Biotech drugs are not the generic products. To market the biotechnology products it is essential to have some knowledge about the product." Commenting on a career in marketing with specialization in biotechnology, Narayan said, "Biotechnology is still not a common phenomenon in India. The future is bright as many companies are looking at biotechnology as new opportunity. We are looking at recruiting 5-10 students from department of management sciences (biotechnology) every year . This year we have recruited about eight students." "When we look at students from high profile management institutes like IIMs, they prefer to opt for FMCG, MNCs, software and other general companies. They do not look at the pharmaceutical market. And then they do not stick to the job for a long time," observed Narayan. The MBA-biotechnology program initiated by the University of Pune has a student intake of 60 each year with basic qualifications in life sciences, natural sciences, veterinary science, ayurveda, allopathic medicine, engineering, etc. The favorable industry response will encourage the university to move ahead and churn out quality student force. But at the same time the university has to look into the student's aspirations for further specialization and studies. This will go a long way in strengthening the industry-academia relationship and help catalyze and direct the biotech revolution. Narayan Kulkarni   ]]> <![CDATA[Small Wonder]]> https://biospectrumindia.com/news/95/1137/small-wonder.html https://biospectrumindia.com/news/95/1137/small-wonder.html Thu, 10 Jun 2004 14:57:00 +0530 Bhat Biotech Small Wonder This is one among the first few Indian diagnostics' companies to receive the ISO 13485: 1996 certificate. It is all set to launch its malaria diagnostic kit shortly and will be coming out with a tumor marker kit in the next 2-3 months. Bangalore-based Bhat BioTech recently won ISO 13485:1996 certification. This certification assumes significance, as it will facilitate the company to reach out the global markets. "This certificate is a prerequisite for CE marking and FDA approval 501K. If you have the ISO 13485 it becomes very easy to get the CE marking. We are getting it for our pregnancy tests. For entering the European market you should have the CE marking and soon it will become mandatory for all the devices to be sold in the UK and Europe. This is a certification of the quality and the process, it is almost like the WHO GMP norms for the devices but is given for the product and not for the system," informed Dr Shama Bhat, founder and managing director, Bhat Bio-Tech. Bhat Bio-Tech claims to already have ISO 9001 and WHO GMP certification for all its products. "Without these certifications we could not have gone to countries like the UK and South Africa. Because the first question that they ask is whether the company is ISO certified, then they ask is it GMP certified? These are the major certifications that they are looking at." Started in 1994 by Dr Shama Bhat, operating in the area of manufacturing of diagnostic kits and recombinant protein reagents, the company has grown its product range to over 60 products in 2004â€”pregnancy, HIV, Hepatitis B and C, urine chemistry diagnostic kits to name a few. The company has considerable oversees presence in nearly 12 countries including South Africa, UK, Nigeria, West Indies, the Caribbean Islands, Peru and Malaysia. The last few months have been really good for Bhat Bio-tech. It has received a good order from an UK-based company for making pregnancy kits. "I have received a sizable order from South Africa. This is our third order and we will be getting orders from South Africa every other month now. The orders are now picking up," shared Dr Bhat. Globalization and portfolio extension, the new mantra Leverage and expand. This has been Bhat's business approach. "When we thought of setting up a company, we wanted to venture into two areas mainlyâ€”diagnostics and biopharmaceuticals or recombinant based products. These could be pharmaceutical or industrial products. It took us nearly seven years to start the recombinant-based products. Today, we have four recombinant products (HIV-1-gp 41, HIV-1-p24, HIV-2-gp 36 antigens, and Protein A), which are used for making the diagnostic kits," further elaborated Dr Bhat. At present the strength of the company is 65 including the marketing team and an R&D team of 12. During the last fiscal year Bhat Bio-Tech posted a turnover of Rs 3.5 crore and this year its turnover is projected at more than Rs 5 crore. "Government can play a key role in the growth of small biotech units" How do you foresee the future of the diagnostic sector and what are your plans to cope with the growing competition? The global diagnostic sector is all set to grow by at least 20-30 percent and in India the growth will be much more as the diagnostics field is relatively new (not more than 10 years old). Globally, the Chinese products are a major threat. China is dumping the products at such a low rate in the market that it is very difficult to match them. Most of the Chinese companies are based in the US, with their production plants/facilities in China. A few Taiwanese and Korean companies are also there. So the idea is to match their price and of course our quality is any day better than that of the Chinese kits most of time. There is a problem with Chinese quality as they mass-produce and their system is not that good. But I do not know how some of them sell products, which is below our cost. In India, there are four companies that are real diagnostic kit manufacturing companies and we can compete with them both product and price wise. J Mitra is the market leader in HIV kits and Span diagnostics is the leader in biochemistry and other kits. Tulip manufactures most of the rapid tests. Then there is Bangalore-based Xcyton, which has kits like HIV Elisa and HCV Elisa. Like wise, we are also the major producers of all these kitsâ€”HIV, Hepatitis B and C, urine chemistry, etc. How do you source funds for the company? At present it is internal. We are thinking about venture funds but they are not at all available for the smaller sector. For a small company, it is very difficult especially if you are looking at Rs 1-2 crore. Nobody is interested in investing that kind of money. They are looking at Rs 4 crore or more. And we did not want to borrow too much as that would strain our capability in case we are not able to sell the products within the stipulated time. Initially, we received some government support, we got a term loan from KSIIDC and then we got a subsidy of Rs 30 lakh from the Karnataka government. Now we are in the process of registering as an R&D company with the central government so that we can try for funds through programs like Technology Development Board (TDB). But one thing common for getting funds is that you should be a sizable company. For a small company it is very difficult. Bhat Bio-Tech is now venturing into contract research. This is an extension to its ongoing contract manufacturing in diagnostics. This year, it has added up another 6,000 sft area to its facility and also modernized the manufacturing area with class 10,000 clean room. Dr Shama Bhat believes that contract research and manufacturing is a good model for growth for a small and growing company like his. Another example of leveraging its strengths is introduction of biotech teaching kits and training programs. This initiative is aimed to address the lack of quality teaching kits (except those supplied by Bangalore Genei) in colleges imparting biotech education. Dr Bhat felt that training programs are a must, as most of the colleges do not have good facilities for training. Since the company had all the equipment in place and very good trained personnel, it started giving training in basic and industrial biotechnology, which is not possible to impart otherwise in colleges. The company charges a nominal fee for the courses to cover for the costs and other incidental expenses. "I get nearly five enquiries every day by mail, through phone or in person from students for industrial training. So we thought why don't we start a regular program from which people can benefit. It is the need of the hour. There are very few biotech companies that are doing this kind of work," added Dr Bhat. Future plans Bhat Bio-Tech is not doing any kind of core research work but is doing more of development. In the future, it is bringing out several other diagnostic kits like that for malaria, which is ready, except for some evaluation tests and licensing. The other products in the pipeline include the TB kits and tumor markers for cancer marker kits and then western blot kits. Next, the company wants to make the PCR-based kits for all the infectious diseases like HIV and HVC. It already has the know-how and the basic technology and only has to modify it a bit to suit particular diseases. "We are a growing company and want to bring out at least 5-6 products every year. And once you establish yourself in the market then automatically contract manufacturing comes in," opined Bhat. Besides making diagnostic kits, the company also plans to start manufacturing generic biopharmaceutical products (like insulin and growth factors) in the next six to eight months. Rolly Dureha ]]> <![CDATA[Licensing In Biotechnology]]> https://biospectrumindia.com/news/95/5646/licensing-in-biotechnology.html https://biospectrumindia.com/news/95/5646/licensing-in-biotechnology.html Thu, 10 Jun 2004 14:55:00 +0530 Licensing In Biotechnology The journey of an invention from lab to the market is a long and winding one with many hurdles and may pass through bridges such as licensing and assignment before its end. 1. Strategy There are at least two common methods of exploiting a technologyâ€”license and assignment. A patent enables its owner to stop the public from using, making or manufacturing the invention for which the patent has been granted. It includes within its sweep the right to mortgage, license or assign one's interest in the patent to another. An assignment in effect is the complete transfer of one's rights and interest in a patent to another. After such assignment, the patent owner divests himself of ownership and the purchaser is the owner thereof. A license under Indian law is a right that is given to a person to do something, which otherwise is unauthorized and illegal. Upon grant of a license, the patent owner does not divest himself of ownership in the patent or the technology in question and continues to exercise all rights as owner therein. In practice however, a license extends beyond the patent to include the technical know how as well. Assignment type of transaction is effected in cases wherein the patent owner is really convinced that he has no use for the technology or that he cannot in any manner exploit it. It occurs when a company is taken over by another or at the time of its winding up. A license type transaction is chosen with a view to retain hold of proprietary rights of the technology as well as earn reward for the efforts made in developing the technology. 2. Overall structure of transaction Prior to execution of a license or assignment, it is important to ascertain what exactly is required to be licensed or transferred. Consider a situation wherein one had patent rights to a novel medium for culturing cell lines and a method for developing cell lines using the medium and the purchaser/licensee uses only a specific cell line, it is sufficient to license the culture medium and there is no need to license the patent relating to the use of the medium. Similarly, where a broad patent covers a diagnostic tool useful for probing several diseases, a part of the patent relating to the use of the tool for diagnosis of a specific disease may be provided. In cases that involve technology that is yet being developed, like collaboration for identification of new chemical entities from a plant extract, it is advisable to set out specifically the scope of the project in a separate schedule as it avoids a lot of confusion when the agreement is subject to post-mortem after 10 years. Often parties prefer to set out in this clause the obligations of each party in the contract. The milestones to be achieved are also set out making it easy for future reference. For example, where a project relates to identification of proteins useful as drug targets and raw material is to be prepared and supplied by different parties, it is so set out in the contract with approximate time lines so as to keep the project on track. 3. Licensed Products Apart from defining the scope of license, it is important to define the product(s) that are licensed. It is important to define the licensed product so as to limit the use by the licensee, of products that do not fall within the definition. As an example, if the licensed product is a cell line, the licensor may, by appropriate definition, restrict use of materials other than the actual cell line that has been licensed and thus prevent the licensee from preparing and using derivatives or progenies of the licensed cell line. Improvements that make the licensed product more efficient are usually kept out of the definition of licensed products. They may be offered to the licensee for an additional fee. In some cases, improvements may be made by the licensee. In such a case the parties may agree that the improvements may be licensed free of cost to each other or offer the right of first refusal to the other or license the improvement for a concessional fee. 4. Material transfer Where the license relates to a cell line or any similar biological material, the fact that material has been provided to the licensee must be stated with an acknowledgement thereof from the licensee. The licensee would need to insist that the product licensed is fit for the purpose licensed. 5. Consideration: product/services/technical know how Monetary compensation is the most direct form of reward to an inventor. And it is often a bone of contention in almost every transaction. In a transaction like an assignment wherein the patent owner divests all his rights and interest in the patent once and for all in favor of the assignee, the payment is usually as lump sum for the technology and the patents assigned. A license on the other hand, may involve a combination of lump-sum payment and royalties or just work around royalties. Milestone payments track the timelines set by the parties, rewards the licensor for value of the invention, the value of which was unproven at the time of license. A license relating to an expression system could involve payment of a fee at each stage of scale up right from laboratory to pilot plant to clinical trials. Sometimes, parties agree to pay a fee for every one thousand assays, such methods often prove to be cumbersome and difficult to police. The fee structure varies depending on scope of license, age of technology, market demand, profit margin, proprietary position of the licensor and strength of the technology. Yearly or quarterly fee are the common yardsticks for royalty payment. Setting a royalty rate for a product may be very difficult especially in case of biotechnology products, because technology is often licensed at a nascent stage when the form of the final product may not be known. Following are some common strategies followed in this area, although they may not be treated as thumb rule: Lump sum payment for initial stages followed by royalty payment on/after the launch of the final product. If final product is known, set a modest base rate that is scaled up depending on the success of the product Calculate royalty on every piece of the licensed product sold in the market or on net sales in a specific territory or worldwide. 6. Intellectual Property Rights Very often, parties provide that all intellectual property rights in the technology transferred which may be by way of patents, trademarks, copyrights or trade secrets that vest with the licensor are also being licensed to the licensee. Without this clause, the licensee may have to negotiate with the licensor separate terms for use of these rights. For instance, if a screening assay is licensed together with the software that identifies various sequences of a particular type, one may not be able to copy or modify it, if the licensee had no rights to the software. The clause must define and include confidentiality obligations of either parties. In India, any interest created in a patent must be registered with the Patent Office, which includes a license. Hence, the licensor and licensee may have to take steps in this regard. Parties also need to negotiate as to who is to assume responsibility for maintenance of IP rights and for enforcement thereof. If the license granted is exclusive, it is the duty of the licensee to take action against infringements or at least bring it to the notice of the licensor. 7. Indemnities and Warranties In any technology transfer, the licensee would be within his rights to ask for at least the following assurances from the licensor: Encumbrance free technology The technology being licensed is novel and does not infringe the intellectual property rights of a third party The licensor has the right to enter into this contract (and has not granted licenses to other parties). A licensor may in turn limit these assurances to the specific technology licensed and not any appurtenant technology. Product liability is an issue that must be negotiated depending on the level of participation by the licensee in market launch of the product. Perhaps, it is here that insurance covers assist the licensor. In India, the concept of patent insurances is still at a very nascent stage. 8. Exclusivity Licenses granted may be exclusive i.e. limited to a single party or to several parties. The license may be limited to a specific territory or worldwide. Exclusivity is usually with respect to a party. Parties do make arrangements such that the licensor retains the home territory and licenses out the rest of the territories thereby enabling the licensor to freely exploit the technology at least within his own home territory. The only limitation of a worldwide license is that it could limit the freedom of the licensor in improving the technology and this is often the case when rights are assigned. An important issue to be negotiated may be whether a licensee is entitled to sub-license the rights acquired. It is often practical to do so if the technology has far reaching applications. 9. Termination and Miscellaneous clauses Structuring the end of the transaction is as important as the beginning. Key questions that this clause must answer: Which obligations would survive termination? What about products already in market? Rights of third parties, if third party interests such as sub-licenses have been created Rights and duties of parties at the time of termination Whether non-solicitation covenants are required? Arbitration and jurisdiction Conclusion There is no one-fit all master agreement that would fit all types of transactions because with time we realize each transaction is one of its kind. The goal is to achieve a good agreement, which clearly reflects the intention of the parties and chalks out the options they have in mind. Apart from consistency and clarity, overly limiting clauses or those that are lop-sided should be clearly avoided to create a win-win situation for both parties. By Rajeshwari H rajeshwari@knspartners.com K & S Partners K&S Partners is a full-fledged intellectual property law firm with offices in New Delhi and Bangalore. It specializes in the entire gamut of intellectual property laws, protection and enforcement. ]]> <![CDATA[FDI in biotechnology]]> https://biospectrumindia.com/news/95/1669/fdi-in-biotechnology.html https://biospectrumindia.com/news/95/1669/fdi-in-biotechnology.html Thu, 10 Jun 2004 14:38:00 +0530 FDI in biotechnology Investment in the Indian biotech industry is currently estimated at about $2 billion and is expected to reach about $10 billion by the end of this decade, largely due to growing multinational collaborations and indigenous R&D efforts. Realizing the importance of biotechnology, the Government of India through its Department of Biotechnology (DBT), has recently came out with a 10-year plan. The plan identified major areas for research, development and commercialization, which include genomics, bioinformatics, agriculture, plant and animal biotechnology, etc. In the healthcare segment, four areas have been earmarked for investmentâ€”medicines, vaccines, diagnostics and gene therapy. Several Indian states including Karnataka, Tamil Nadu, Andhra Pradesh and Maharashtra have framed policies for attracting investment in this sector and offer fiscal benefits and other incentives such as land grants for training institutes, labor concessions and assistance with funding. Bioinformatics Computing has joined forces with biology to create bioinformatics, which is concerned with the acquisition, storage and analysis of biological data. Once an obscure part of computer science, bioinformatics has become a linchpin of biotechnology's progress. This opportunity has not been lost on IT companies. Governance of biotechnology The following legislation are relevant: Environment (Protection) Act, 1986 (hereinafter referred to as EPA) Rules for the manufacture, use, import, export and storage of hazardous microorganisms, genetically engineered organisms or cells, 1989 (hereinafter referred to as Rules) Department of Biotechnology Guidelines, 1998 Related laws Protection of Plant Varieties and Farmers Rights Act, 2001 and Rules 2003 Indian Patents Act, 1970, Amendment Act, (1999) and (2002) Seeds Act, 1966 and Seeds Rules, 1968 The Plants, Fruits and Seeds (Regulation of Import in India) Order 1989 Public Liability Insurance Act, 1991 EXIM Policy, Proposed new Acts/Amendments to be brought out by the Government Seeds Bill, 2003 Patents (Amendment) Act, 2003 The DBT and the Genetic Engineering Approval Committee (GEAC) constituted under the Ministry of Environment and Forests are the lead regulatory bodies for biotechnology in India. Agricultural biotechnology In the field of agricultural biotechnology, huge business opportunities lie for foreign bioscience firms seeking research and business alliances with Indian firms. Under the Government of India's foreign investment policy, a person residing outside India, including a corporation, can invest by way of subscription to shares of an Indian company, provided the Indian company is not engaged in any activity listed in Annexure - A to the Foreign Exchange Management Regulations, 2000. This would include agriculture and plantation activities. For other sectors, including biotechnology, the automatic approval route of the Reserve Bank of India (RBI) would be available, subject to equity caps provided in Annexure - B of the said Regulations. A proposal to carry out any project involving GM/transgenic crops including planting, testing and handling of GM/transgenic crops in laboratory and greenhouse/net-house experiments and trials, small-scale and large-scale open field trials and the import of GM crops, will require clearances and approvals from the following authorities: Institutional Biosafety Committee (IBSC) - Implements and enforces biosafety guidelines on specific projects in research centres, universities and other national laboratories. Review Committee on Genetic Manipulation (RCGM) - Authorizes containment conditions for experiments, small-scale field trials and monitors those trials to ensure that safety standards are met. The RCGM also approves import requests for products needed for experimental work/training and research, such as agents, vectors, germplasms, etc. Genetic Engineering Approval Committee (GEAC) - It regulates large-scale trials and environmental release of all GM organisms, as well as, all imports and exports of GMOs. GEAC also issues licenses under the said Rules after reviewing all the necessary studies of trials, environmental safety aspects and other supporting documents. Import of GM/transgenic crops The import of GM/transgenic crops is allowed for limited research purposes. These imports require an import license in terms of the EXIM Policy of the Government and other applicable legislations regulating the import of GM/transgenic crops including the Order. An import license can be obtained from the Department of Agriculture and Cooperation, Ministry of Agriculture (DAC). Pharmaceutical biotech DBT has developed guidelines for clinical trials of recombinant products. Promising leads now exist to develop vaccines for rabies, tuberculosis, cholera and other diseases. Recombinant hepatitis B vaccine and LEPROVAC are already in the market. Any person residing outside India including foreign companies, non-resident Indians and overseas corporate bodies can invest upto 100 percent under the automatic route of RBI by way of subscription to the shares of an Indian company engaged in the manufacture of drugs and pharmaceuticals. But this is subject to the condition that the activity does not attract compulsory licensing or involve the use of recombinant DNA technology and specific cell/tissue targeted formulations. Investment in Indian companies engaged in manufacture of licensable drugs, pharmaceuticals and bulk drugs produced by recombinant DNA technology might also require regulatory approval. Taxation Since 2001, the Indian government has been providing for a huge increase in research and development expenditure in its annual union budget and provides biotechnology companies with an R&D tax deduction of 150 percent. However, this does not include expenses incurred for the cost of any land or building. In a bid to attract investors, some Indian states have offered concessional or nominal sales tax rates for "high-end" new biotechnology products (as notified by the state government) manufactured by units located within biotechnology parks established within those states. Intellectual Property Rights India is a signatory to the Trade Related Intellectual Property Rights (TRIPS) Agreement, which has been incorporated in part, in different Indian legislations including the Patents (Amendment) Act 1999, 2002, the Protection of Plant Varieties and Farmers Rights Act 2001 (PPV Act) and the Trade Marks Act 1999. The PPV Act provides for protection of registered varieties of plants, for a period ranging from 15 to 18 years (depending on the kind of plant variety), and includes the exclusive right to produce, sell, market, distribute, import or export the variety or its propagating material and license it to other persons to do the same. Conclusion There are numerous opportunities in the biotechnology sector in India. However in order to harness these care must be taken to address the above issues in an enabling business environment with a pragmatic, entrepreneurial mindset. Kirit Javali Partner Law Offices of Jafa & Javali advocates@jafajavali.com ]]> <![CDATA[Pharmaceutical Growth & Profitability Summit]]> https://biospectrumindia.com/news/95/6197/pharmaceutical-growth-profitability-summit.html https://biospectrumindia.com/news/95/6197/pharmaceutical-growth-profitability-summit.html Thu, 10 Jun 2004 14:35:00 +0530 June 2004 Pharmaceutical Growth & Profitability Summit SR institute is organizing the Pharmaceutical Growth & Profitability Executive Summit on June 21-22 2004 in Park Hyatt at the Bellevue Hotel, Philadelphia. The summit provides cutting-edge economic, R&D and financial strategies via keynote presentations and panel discussions. The meeting will cover comprehensively the most timely topics for revitalizing revenues including medicare and regulatory policy concerns, pricing, reimbursement, generic competition, imports, R&D attrition rates and productivity strategies, innovative marketing approaches, M&A, patent expirations, etc. For further details, contact: hwoji@srinstitute.com Outsourcing of Pharma Chemistry Drug Discovery & Manufacturing This annual outsourcing event will be held on July 14-15 2004 in Wyndham Philadelphia at Franklin Plaza Hotel, Philadelphia. The 8th international Outsourcing of Pharmaceutical Chemistry, Drug Discovery & Manufacturing meeting is the information and networking conference and exposition that brings together from around the world the pharmaceutical, investor, and service provider communities to address the fast-growing, changing and globalizing system of services for the life sciences industry. The meeting will emphasize on early discovery outsourcing, as well, as process research and development, intermediates, API and manufacturing. For further details, contact: malexay@srinstitute.com Antibody World Summit 2004 Strategic Research Institute is organizing the 3rd Annual Antibody World Summit at Crowne Plaza Philadelphia Hotel, Philadelphia, PA from July 19 to 21, 2004. The summit offers the opportunity to learn about the latest in antibody technologies, production, and therapeutics from the industrial, academic and financial communities. The conference consists of three tracksâ€”antibody discovery & development; antibody deal making & financing and biopharma production & manufacturing. For further details, contact: malexay@srinstitute.com Bioinformatics of Genome Regulation and Structure The Fourth International Conference on Bioinformatics of Genome Regulation and Structure (BGRS'2004), a biennial event, will be held from July 25-30 2004 in Akademgorodok, Novosibirsk, Russia. This is a multidisciplinary conference and scientists with an interest in bioinformatics, mathematical, theoretical, or computational biology will benefit from the meeting. The event includes development and application of advanced methods of computational and theoretical analysis to structureâ€“function genome organization, proteomics and evolutionary and system biology. For further details, contact: orlov@bionet.nsc.ru Structural Approaches to Sequence Evolution The workshop on "Structural approaches to sequence evolution: Molecules, Networks, Populations" is being held from July 5-10 2004 at Dresden, Germany. It aims to bring together people from different scientific communities working in the three areas of theoretical and empirical studies of population dynamics, computational and experimental studies of the stability and properties of biological macromolecules and statistical analysis of sequences databases. The possible synergies between these experimental, theoretical, computational, and statistical analysis approaches are anticipated to improve the understanding of the processes and pathways of molecular evolution. For further details, contact: porto@mpipks-dresden.mpg.de Bangalore Bio 2004 Bangalore Bio2004, the fourth edition of Asia's premier biotech event will be held from 11-13 July 2004 in Palace Grounds at Bangalore. The event is being promoted by Govt. of Karnataka and Vision Group on Biotechnology. This annual international event is a networking opportunity for technologists, entrepreneurs and scientists to showcase their products and services. It expects 150 exhibition participants, 500 delegates, 30 countries, 9 Indian states, 20,000 trade visitors and 30,000 general visitors, at the 3-day tradeshow, conference, B2B forum and knowledge pavilion. For further details, visit: www.bangalorebio2004.com     ]]> <![CDATA[GM research with little sense]]> https://biospectrumindia.com/news/95/1142/gm-research-with-little-sense.html https://biospectrumindia.com/news/95/1142/gm-research-with-little-sense.html Thu, 10 Jun 2004 13:42:00 +0530 GM research with little sense At the national symposium on Relevance of GM Technology to Indian Agriculture and Food Security, organised by Gene Campaign some months ago, two issues were raised repeatedly. One that India needed to tailor its GM research program carefully to specifically target problems faced by Indian agriculture. This is especially important because public research budgets are modest and the money must be spent wisely. The second point was that the system for regulating GM crops in India was appalling and needed to be overhauled immediately. In light of these strong sentiments expressed at the national symposium, it is distressing to note the direction of the GM research agenda being funded by the Department of Biotechnology in India. So much of the research is copycat, merely repeating what scientists elsewhere have already done. Much is peripheral to the needs of Indian farmers. Some is plainly nonsensical. The Department of Biotechnology at the University of Agricultural Sciences (UAS), GKVK Campus, Bangalore has two projects on developing GM crops that illustrate what I mean. One project is on edible vaccines where the scientists are trying to put the cholera vaccine gene into muskmelon; the reasoning probably is that vaccination can be made simpler by putting the vaccine into a food that can be consumed easily. The other is a project on putting the insulin gene into groundnut, as a potential treatment for diabetes. The reasoning here is that diabetics could take their insulin by eating the doctored groundnuts. Edible vaccines look attractive as a concept but their implementation in India could turn into a nightmare. How, for example, would one distinguish between a vaccine carrying fruit and non-vaccine muskmelon? What would happen if one were to eat too many muskmelon containing the vaccine because the vaccine fruit reached the fruit vendor due to some mix up at harvest/sale? One muskmelon would look pretty much like another. Or, suppose the muskmelons were eaten when they were raw or overripe? What would happen to the prescribed dosage in that case? Would a child have eaten too much vaccine? Too little? What consequences would this have? This is like putting the cart before the horse. Is the research concept of an edible vaccine in a perishable, seasonal fruit like muskmelon, a sound one? Muskmelon in India is essentially a crop of the river sandbanks in the plains of north India. It is a summer crop, which ripens and is at its best in May and June, before the onset of the monsoon around mid-July. Muskmelon does not grow in winter, it does not grow on the hills and it does not grow, for instance, in Kerala or Kutch. So this edible vaccine would be available only in a specific geographical region and only during a specific season. It would not, for example, be available to handle a cholera outbreak in Mussoorie or Darjeeling. Being a seasonal fruit with high water content muskmelons are highly perishable with a short shelf life. They are also difficult to transport and are hence unsuitable as a crop to carry vaccines. This kind of research should have never been sanctioned. In fact the whole concept of edible vaccines is a flawed one as pharmaceutical plants landing up in the food chain show. The research on inserting the insulin gene into groundnuts to find a cure for diabetes is even worse. Insulin is a protein. If there were indeed an insulin-carrying groundnut, once it was eaten, the insulin in it would be digested by the gastric juices just like all the other protein in the groundnut and lose its identity as insulin. Proteins are broken down in the digestive tract into amino acids, which are then absorbed by the body as nutrition. The same thing would happen to insulin. So an insulin-containing groundnut would deliver amino acids to the diabetic, not the insulin that the patient needs. As insulin gets broken down in the stomach, no oral form of the medicine, like tablets or capsules, have come to the market. The insulin dependent diabetic can be treated only with injections since this is the only way that insulin retains its integrity when it reaches the bloodstream. In that form, it can break down the sugar that is collecting in the blood and keep the disease under control. So the insulin-in-groundnut research is conceptually flawed, headed nowhere and is a waste of the taxpayers' money. This is another research project that should not have been sanctioned but the question is, who is granting scarce research funds to these dead end projects? Who is taking these decisions? Are the top science echelons themselves incompetent or is there apathy of such high order that no one cares about wasting money and making laughing stocks of ourselves? We need a thorough review of the GM research program in India and we need to set up a competent multistakeholder body that will decide on India's research priorities after an appropriate consultative process. By Dr Suman Sahai Dr Suman Sahai has a Ph.D in Genetics and has several years of research and teaching experience in the Universities of Alberta, Chicago and Heidelberg. Dr Sahai is a member of several national policy forums on environment, biotechnology and Intellectual Property Rights as well as education and health. She is also the convenor of Gene Campaign, New Delhi. Suman Sahai can be reached at: genecamp@vsnl.com   ]]> <![CDATA[IDEX acquires Scivex]]> https://biospectrumindia.com/news/95/3975/idex-acquires-scivex.html https://biospectrumindia.com/news/95/3975/idex-acquires-scivex.html Thu, 10 Jun 2004 13:35:00 +0530 IDEX acquires Scivex IDEX Corporation announced the completion of its previously announced acquisition of Scivex Inc., a leading provider of fluidic components and systems for the analytical, biotechnology and diagnostic instrumentation markets. Scivex, which represents a strategic expansion of IDEX's life sciences business, will be operated as a standalone business as part of the IDEX Pump Products Group. Scivex was previously owned by KRG Capital Partners, a middle market private equity firm based in Denver, Colorado. Commenting on the acquisition, Dennis K Williams, chairman and CEO, IDEX, said, "Scivex fits IDEX's growth strategy exceptionally well and is an excellent addition to our company. The combination of Micropump, Ismatec, Trebor, Rheodyne, Systec and Scivex will significantly enhance our ability to meet our customers' needs in the growing, global market for analytical, biotechnology, medical and diagnostic instrumentation solutions." finalize merger Japanese companies, Yamanouchi Pharmaceutical and Fujisawa Pharmaceutical have reached a definitive agreement for their merger, which is to take effect on April 1, 2005. The two will seek shareholder approval of the Agreement at their respective annual general shareholders' meetings to be held on June 24, 2004. As per the agreement, Yamanouchi will be the surviving company and Fujisawa will be dissolved and the new company will be called Astellas Pharma Inc. Respironics to make offer for Profile Therapeutics acquisition John Miclot Respironics Inc. announced that it would make an offer to acquire for cash the issued share capital of Profile Therapeutics PLC for a total of approximately $44.6 million. The UK-based company, which distributes, develops and commercializes specialty products to improve the treatment of sleep and respiratory patients, would become a wholly owned subsidiary of Respironics and would be integrated into two of the company's divisionsâ€”the international division and the respiratory drug delivery division (formerly the Asthma and Allergy Division). Respironics estimates the acquisition would add $15-20 million to its annual revenues of $23.9 million, after eliminating the impact of inter-company sales, and would be neutral to earnings per share during fiscal years 2004 and 2005. The acquisition has been approved by the boards of directors of both Profile Therapeutics and Respironics and is subject to a UK procedure that is similar in form to a tender offer in the US. "This opportunity is consistent with our strategic plan, which calls for expanding our presence in the international sleep and respiratory markets, and enhances the breadth of our products and services," said Respironics' President and CEO John Miclot. Johnson & Johnson acquires Egea Biosciences Centocor Inc. announced today that its parent company, Johnson & Johnson, has acquired Egea Biosciences Inc., San Diego. The acquisition of Egea Biosciences, the pioneers of a technology platform designed to optimize protein therapeutics, is expected to strengthen Centocor's position as a leader in biomedicines and protein therapeutics technology. Egea's technology will be used to create product candidates that Centocor can further develop, manufacture and market. The two companies previously had an exclusive research collaboration relationship. Egea's platform technology enables optimization of biologics and antibodies for therapeutic use through proprietary large-scale gene synthesis. Informed Glen A Evans, chief executive officer and founder, Egea Biosciences, "We are pleased that Egea's core technology for gene synthesis and protein design will now become an important tool in Centocor's drug development effort." AustCancer to acquire Galenica The Board of Australian Cancer Technology has announced that it signed an agreement to acquire, through its wholly-owned US subsidiary, Adjuvantys Inc., Galenica Pharmaceuticals Inc., a private US biopharmaceutical company for $5 million in a largely scrip offer. Galenica has proprietary technology, comprising three families of semi-synthetic immune enhancers, or adjuvants, used to stimulate the immune system. Employed as stand-alone therapeutics, or as an essential component in vaccines, these compounds have been or are currently being used in cancer vaccines in two Phase I and one Phase I/II clinical trials at leading cancer centers in the US. Galenica also has a licensing agreement with Pfizer Animal Health for a series of animal vaccines in development, which will use Galenica's adjuvant, and with Endocyte for a novel active immune therapy for kidney cancer. The first milestone payment pursuant to the Pfizer agreement is expected in 2005. Benitec acquires Avocel Prof Mark Kay Benitec Ltd has announced the acquisition of Avocel Inc., Sunnyvale, a leading RNAi therapeutics company, and the establishment of its wholly-owned US subsidiary, Benitec Inc. Through the acquisition, Benitec gains its first in-house advanced therapeutic development program using DNA-directed RNAi (ddRNAi) to target the Hepatitis C virus (HCV). Benitec anticipates a ddRNAi-based therapeutic for HCV will enter the clinic in 2005. Under the terms of the agreement, Benitec will issue 7.6 million shares to Avocel, representing approximately 9 percent of the enlarged share capital of Benitec Ltd. In addition to driving forward the HCV therapeutic development program, the merger will provide the US base for Benitec Inc. with laboratory and administration facilities in Silicon Valley. Avocel's co-founder Professor Mark Kay, said, "The ability to apply Benitec's technology will significantly enhance our HCV program, promising several important clinical advantages. Benitec's leading patent position and RNAi expertise, and the commitment of the company to making RNAi therapeutics a reality, are behind our decision to merge. Using the potential of DNA to deliver RNAi provides expanded opportunities not only to develop novel treatments for viral diseases and also other major areas of unmet medical need." UCB offers to acquire Celltech Dr Peter Fellner Brussels- headquartered UCB, which had a turnover of approximately Ã?3 billion in 2003, has offered to acquire Celltech, a leading biotech company in the UK. As per the offer, Celltech's shareholders are to receive an equivalent to $19.44 per American Depositary Share valuing the entire issued share capital of Celltech at Ã?2,252 million. The boards of UCB SA and Celltech Group announced that they have agreed the terms of a recommended cash offer by UCB for the entire issued and to be issued share capital of Celltech has a broad and innovative pipeline including a major new product in advanced phase III trials (CDP 870) for which UCB has entered into a worldwide license agreement. The license agreement is not conditional upon the success of the proposed Offer for Celltech by UCB. And the combination of UCB and Celltech will create a European-based company, which will be one of the largest biopharmaceutical companies in the world. According to Dr Peter Fellner, chairman, Celltech, "Since listing in 1993, Celltech has successfully established itself as one of Europe's leading biotechnology companies built on a platform of internationally respected research and excellent people. UCB recognizes these strengths and this offer represents fair value for Celltech Shareholders." Biolex acquires Epicyte Pharmaceutical Biolex Inc., a privately held protein therapeutics company, has acquired Epicyte Pharmaceutical, a privately held, San Diego-based company focused on the discovery and development of human monoclonal antibodies (mAbs). The combination creates powerful mAbs capabilities at Biolex, and brings to Biolex complementary intellectual property and technology, as well as a pipeline of therapeutic antibodies in development. "This acquisition is another milestone toward realizing our goal of becoming a leading protein therapeutics company and the partner of choice for companies seeking faster, flexible and cost-effective alternatives to current methods of protein expression," said Jan Turek, president and CEO, Biolex. Life Sciences Sector VC favorite in Q1 2004 According to the PricewaterhouseCoopers/Thomson Venture Economics/National Venture Capital Association MoneyTree Survey, venture capital kept up a steady pace in the first three months of the year. Investments in the first quarter of 2004 totaled $4.6 billion going into 618 companies. This figure is below the $5.2 billion invested in the fourth quarter of 2003, but well above the same period last year when investments in Q1 2003 totaled $4.2 billion. Life Sciences companies (Biotechnology and Medical Devices, together) continued to dominate other industries as they have for the past six consecutive quarters. Investments in the sector totaled $1.3 billion, or 27 percent of all venture capital. Proportionately, Life Sciences investing remained near its 12-year high reached in 2003. Biotechnology alone accounted for $943 million or 20 percent of all investing. Medical Devices garnered $325 million, or 7 percent. A total of 71 biotechnology companies and 51 medical device companies were funded during the quarter. The Software Industry inched back into the top slot in the first quarter of 2004 as the single largest industry category after being pushed into second place the last two quarters by Biotechnology. Software companies garnered $956 million going into 162 companies, down slightly from the prior quarter. It may be recalled that venture capital finishes at $18 billion for 2003. Investment in Life Sciences companies outpaced other industry sectors. For full year 2003, the Life Sciences Sector (Biotechnology and Medical Devices, together) attracted $4.89 billion, or 27 percent of all venture capital. This represented the highest proportion directed to Life Sciences in the last 12 years. The largest single-industry category was Software, capturing $3.6 billion over the full year. That figure amounted to 20 percent of all investing, well in line with historical norms for the category. It was followed closely by biotechnology at $3.4 billion. ]]> <![CDATA["Scientists have an obligation to explain science"]]> https://biospectrumindia.com/news/95/7494/scientists-have-an-obligation-to-explain-science.html https://biospectrumindia.com/news/95/7494/scientists-have-an-obligation-to-explain-science.html Thu, 10 Jun 2004 13:35:00 +0530 "Scientists have an obligation to explain science" Continuing our series of "Biotech Gurus", in this issue we focus on Dr Channapatna S Prakash, the founder of the highly successful and popular agricultural biotechnology websiteâ€”Agbioworld. He moderates daily Internet discussion group and newsletter "AgBioView" which is read by more than 4,000 experts in 55 countries. Dr Prakash is a professor in plant molecular genetics and the director of center for plant biotechnology research at Tuskegee University, Alabama, USA. He oversees the research on food crops of importance to developing countries and is actively involved in enhancing the societal awareness of food biotechnology issues around the world. In an exclusive interview, Dr Prakash shares his views about the future of crop biotechnology, its promises and the problems. Excerpts: What was the objective behind starting a website on agricultural biotechnology? I started "AgBioView" in the year 2000 to provide a forum for discussion on issues facing agricultural biotechnology among scientists across the world. Because the products of our research, GM crops, were being increasingly seen as controversial and their public acceptance was being threatened by scare campaigns by the activist NGOs. I felt that scientists must speak up. To empower scientists, it is essential that we understand the root of such apprehension and also recognize that the public and policy makers must be provided with a reasoned, science-based information (in a manner that they understand) by the scientific community. The orchestrated opposition to biotechnology is by a minority of individuals or groups who are very vocal and effective but they must be countered for so much is at stake here. While scientists are not usually trained to indulge in such activism, increasingly it has become essential that we learn to communicate effectively among various stakeholders. AgBioView is sent out daily to more than 5000 readers across the world including hundreds in India. Our readership now not only includes scientists but also the media, students, scholars, environmental organizations and policy makers. It contains important news from across the globe on issues related to agricultural biotechnology and also useful commentaries, research developments, information on scientific meetings, scholarships, book reviews and even occasional humorous pieces. Articles posted on AgBioView are often reprinted in many newspapers, magazines and web forums. I am heartened when many people routinely tell me how useful they find AgBioView. The EU commissioners have granted a license for the import of Syngenta's GM maize. Will this have major bearings on the future of GM crops in Europe? I think that this is a step in the right direction. It is a kind of break on the impact of five years of so-called de facto moratorium. So it is a breath of fresh air for those of us who have been calling for Europe to open up. After all, Europe is the home of this technology and the cradle for the whole of science and technology revolution. And it is not a technophobic continent by any means. Even in the field of biotechnology, it is home to literally thousands of biotech companies both small and big. Europe was dragging its feet in the area of agricultural and food biotechnology and its approval of the insect resistant, Bt11, GM maize variety (developed by the Swiss firm Syngenta) is a step in the right direction. But I still believe that much needs to be done before Europe can open its front to biotechnology without much fear and feel comfortable about it. The European public, the policy makers and the food industry are the three major stakeholders that are holding back in the area of biotechnology in Europe. Both the UK and EU have given a tentative go ahead to biotechnology but with strict labeling and segregation rules. Is this like moving one step forward and two backwards? Well, I think in a symbolic manner even though EU has approved Bt 11, at the moment, Europe by itself is not moving ahead in biotechnology. In England also, though they have approved the GM maize developed by Bayer Crop sciences, but because of the stiff conditions imposed, the company is not marketing it purely for business reasons. This is one of the reasons why I say that Europe has a long way to go. However, at least this is one step forward. But it is so encumbered in traceability segregation and labeling that it is a very hard sell. We are wishing that Europe would open up fully. And I am sure that Europeans will understand that it is in the country's interest and recognize that many countries like North America, developing nations like China, India, South Africa are moving ahead with this technology and none of them seem to be having any problems. All their worry related to the use of technology in food is either very hypothetical or very insignificant in terms of food safety or its environmental effects. Now the world has started recognizing the very positive effects of this technology. Last year alone, in the US, we saw a drop of 21 million Kg of pesticides, active ingredients, so much so that BASF closed one of its pesticide plants because they incurred losses of $175 million last quarter. The rate of pesticide application/sale coming down was directly attributed to the use of GM crops. Today Europe has the highest per capita pesticide consumption in the world. Two countries, Europe and Japan, consume much more pesticides than the US. In Europe people have this image of nice family farms, small farmers and they somehow think that by using better varieties, using biotechnology is somehow going to corrupt the kind of image they have, which is silly, really! It is not going to change one bit, like it has not changed anything for the Bt cotton farmers growing cotton. It is only going to make things better. I am sure that in the next 5-10 years Europe is gradually going to see light but it shouldn't take so long too. As earlier Europe was the seat of action for many of the big biotech companies like ICI, Syngenta, Ciba, PGS and so many others, who had invested so much into this technology and suddenly they started closing shop and moving their R&D units to the US. It is really sad in terms of how this technology could have blossomed into so much more if not for the European intransigence. Monsanto has abandoned its plans to sell GM Wheat in the US. Is this a big setback for the agri biotech sector? I think that more than the US, it is the export of wheat to Europe and Japan that led to this decision. Although, probably only about 10 percent of the wheat produced in the US is exported, but still it was significant enough to have led to this decision. This shows that the perception of the technology in the food sector is not as positive as in the seed sector. Much of the push for biotechnology in the seed sector came from the farmers because they are the direct beneficiaries of the current day technologyâ€”herbicide tolerant, pest resistant, insect resistant crops, etc. The food industry does not see much benefit for itself, at least that is the perception, and this perception is bound to the consumer concerns. When ironically the consumer is not having any concerns, at least not in the US. And even in Japan and Europe it is just the politics of marketing and supermarkets having more clout. It is unfortunate because wheat is one of the largest growing crop in the world and if commercialized this would have had an impact on how the technology could have translated into many more crops. I think that it is a bit of a setback. Labeling of GM products is a contentious issue. Do you think it should be allowed? It is a difficult question as the US does not have any labeling of GM products and yet does not have any problem. Labeling is a very tricky issue and is being enforced not for any health reason but for marketing and it is not going to help the technology much at this moment. Today there is so much of negative perception attached to labeling at least in Europe because of traceability and other issues. Dr CS Prakash has been instrumental in catalyzing the scientific community in many countries to be more proactive in the biotechnology debate. His website has become an important portal disseminating information and promoting discussion on this subject among the stakeholders. The website has received endorsements from over 3,500 scientists from across the world including 24 Nobel Laureates. Dr. Prakash has actively worked to promote biotechnology research and policy in developing countries of Asia and Africa through training of students and scholars, research collaboration and lectures. His contribution to agricultural biotechnology outreach was recognized by the magazine Progressive Farmer who awarded him the 'Man of the Year' award 'in service to Alabama Agriculture'. He was recently named as one of a dozen 'pioneers, visionaries and innovators behind the progress and promise of plant biotechnology' by the Council for Biotechnology Information. Dr. Prakash received a bachelor's degree in agriculture and a masters in genetics from the University of Agricultural Sciences, Bangalore, India. He obtained his Ph D in forestry/genetics from the Australian National University, Canberra. His research interests include studies on transgenic plants, gene expression, tissue culture and plant genomics. Dr Prakash's group at Tuskegee University has led the development of transgenic sweet potato plants, identification of DNA markers in peanut and the development of a genetic map of cultivated peanut. Currently, he serves as the principal investigator of a USAID funded project to promote biotechnology awareness in Africa. He has more than 50 scientific publications in refereed journals and has presented more than 100 papers. Dr. Prakash serves on the scientific advisory board of American Council on Science and Health (NY), BioScience Policy Institute (New Zealand), and Policy Network (UK). He also serves on the editorial board of AgBiotechNet and AgBioForum, the Journal of New Seeds, Indian Journal of Biotechnology, Food Biotechnology, and the Journal of Plant Biochemistry and Biotechnology. Dr. Prakash often serves as a speaker on behalf of the US State Department and has traveled to many nations across the globe for delivering public lectures, interacting with the media and meeting with policymakers, scientists, activists and trade experts. I believe that labeling is very important. The laws of labeling should be made keeping the interest of the consumers in mind. And traditionally labels all around the world are meant for two major things. One for providing information on content and second to provide any health related information and warning. So writing about an ingredient sourced from a GM crop has nothing to do with either. For instance, if you buy a bag of potato chips you do not know what variety of potato has been used, what pesticide was used and where it was grown because it is immaterial. It has no relation either to the nutritional aspects of the food that one is consuming or to the health and allergies concerns. By putting on the label that it is a GM food, you are actually stigmatizing the product just because it is biotech. When there is absolutely no scientific proof anywhere in the world that because of being biotech/genetically modified it somehow has an extra element of risk. There is none! While those who have a vested interest in opposing the product like the organic food industry or the anti biotech activists will have an advantage in maligning the product. What you provide on the label should be factual and verifiable. When you talk of labeling sugar, oil, etc as GM or non-GM, then it may so happen that you use a GM crop with all its health benefits and still label it as non-GM and it will be very difficult to trace that. This is the reason why FDA has resisted labeling. The only compromise that they made was to certify organic food where they cannot use any GM variety. Thus, following all the traceability rules is very difficult for developing countries. It is draconian in terms of what has been put together. To give an example, if you are eating a chocolate bar and you want to know in what form the cocoa or sugar were used I think it is stretching the things a bit too far. How do you foresee the future of crop biotech nology in the African continent? I think Africa is going to move slowly though public perception is not a big problem there. It is a country like India where perception is not a major issue except for a few intellectuals here and there. The biggest problem in the African continent is that apart from South Africa and some parts of the Arab world like Egypt, there is hardly any technology research being done. Africa is where agricultural biotechnology's greatest promise lies. In Africa biotechnology has the potential of increasing the agricultural productivity, developing crops that are tailored for harsh environmental conditions, marginal soils, etc. But this cannot be done in many of the African countries simply because of lack of research infrastructure, lack of policy supporting, forget biotechnology, just simple agricultural research. And so there is no point in having computers when people are illiterate. So what is required there is something more basic. Just like how the green revolution was brought into countries like India with the help of an international consortium of institutions, a similar model will work for Africa at the moment. In other words they have a need for crops like cassava that is virus resistant, banana that is fungus resistant and perhaps corn that is herbicide resistant and disease resistant cowpeas. These are the major African crops, and improving them is very simple. For example disease resistant cowpeas, it is an off the shelf technology, you just take the Bt gene which is there in cotton and put it in cowpea, it will be protected. Even the seeds are given free and the farmer does not have to make any extra effort. It is not a destructive technology and does not call for a lot of investment also. These things could be put into place by international institutions, donor agencies and western labs working in consort with the local African agricultural scientists. Some efforts are being made in this direction by the CGIAR system, National Centre of Tropical Agriculture, some of the other centers working in Africa including ICRISAT, donor agencies like the Bill Gates foundation, which has recently pledged $25 million for this effort. These are some of the medium term applications of biotechnology that will come in Africa. What are the major problems hindering the growth of agricultural biotechnology in the world today? The crux of the problem hindering the growth of agricultural biotechnology around the world can be divided into three major issues. Trade - Till the time the South African countries perceive that bringing in biotechnology will jeopardize their trade, they will not go for it and that is what happened in Zambia, which literally shot itself in the foot by refusing food grains last year and Angola did the same this year. They were purely driven by fears of their trade being threatened. To give an example, Namibia is a small country and is one of the biggest importers of corn. It cut off all its corn trade with South Africa because the latter grows GM corn and Namibia is the largest exporter of beef to Europe. Now though Europeans are the biggest consumers of GM food for the life stock and would not have had a problem but due to the perception of some food companies that source beef from Namibia, it could have taken this step. So countries that have nothing to do directly with biotechnology but due to the fears of trade avoid adopting it. Another example is Thailand, which has done excellent research in rice biotechnology since the last 15 years but does not want to opt for biotech crops, as it is the largest exporter of rice to the world including Europe. China is a good example. It has approved Bt cotton long time ago but has yet not approved Bt corn, although GM corn has been on field trials since more than the past eight years. It has not approved the commercialization of Bt corn as it exports corn to Korea and Japan. It is sad that trade more than any other concern is the guiding factor in growing/commercializing GM crops. Biosafety regulations - The current regulations are very burdensome, costly and mostly unscientific. The regulation or too much of it is another important factor hindering the growth of agribiotechnology. Even the US grows only 3-4 GM crops. Monsanto, that has spent $1 billion a year for the past 10 years which is probably more than what we have spent on agricultural biotechnology research related to developing countries in all the past 20 years and yet what products do we see? Hardly a handful on cotton, soybean, canola! And all these are just insect tolerant or Bt. They have many other products like virus resistant potato, sweet corn, etc but none of them have been brought in the market because the cost of regulation is very high. And this not a case specific to the Monsanto's products but is common in the entire food industry. Today amongst the whole range of biotech products/food there is no whole food other than papaya, all other biotech products are processed foods. To illustrate the cost of regulation, lets take a product that is of direct relevance to the consumer especially from a health point of view. Assume that there is a groundnut oil that is better in quality with low saturated fats, almost as good as olive oil. Today, we do have the technology to do it, but the point is if you spend $5 million to develop that groundnut, it takes another $20 million to prove that it is safe. Although it may be just turning off one gene and not much conceptually to worry about. But yet the burdensome regulations that just don't regulate it in the country in which you are growing, you also have to worry about the regulations in the country, which is importing it. You have to satisfy all of them! So why bother? And that is why most of the companies have put some very promising technologies on the shelf. Development of GM crops is an expensive process and scientifically very sophisticated but its commercial release is almost prohibitive because of the burdensome regulation and bureaucratic red tape. The extra cost of justifying the product safety is invariably passed on to the consumer. So just like the pharma industry is in search of blockbuster drugs to cover the cost of developing a new drug. Similarly the agri industry wants to go for a blockbuster, no one wants to bother for cassava, cowpea, etc, they want to go for something big. This is really sad because many of the crops, which are of direct benefit to the consumers include healthier fat, better starch more vitamins, better appearance flavor and color all of which are technically possible and yet are not going to happen. Food Industry - There is a certain kind of monopoly when it comes to food in the western world. Like for potato, Mac Donald is a big buyer. And though we had a GM potato, which was nearly similar in all respects to the normal potato and is practically pesticide free, but it cannot be introduced because of the company monopoly, which dictates terms. N Suresh & Rolly Dureha     ]]> <![CDATA[Blending Ethanol with Diesel]]> https://biospectrumindia.com/news/95/2719/blending-ethanol-with-diesel.html https://biospectrumindia.com/news/95/2719/blending-ethanol-with-diesel.html Thu, 10 Jun 2004 13:31:00 +0530 Blending Ethanol with Diesel After the success of green and white revolutions leading to self sufficiency in food grains and milk production, the government is now looking at 'Krishna Kranti' (black revolution) to not only help India become self-sufficient in oil production but also provide a healthy environment to the people. Blending ethanol with petrol has become a reality after nearly six years of study. The five percent ethanol-blended petrol is now available in nine states and four union territories. The government is extending this program to other states also. In addition, it is actively looking at blending ethanol with diesel, as diesel alone constitutes about 80 percent of the automobile fuel consumed in the country today. The government has already sanctioned Rs four crore for the R&D studies, which are at an advanced stage, nearing completion now. Train on track The Indian Railways is also experimenting with the new eco-friendly "biodiesel" fuel to run passenger trains. The first successful trial run of a superfast passenger train was conducted on December 31, 2002 when Delhi-Amritsar Shatabdi Express used five percent of "biodiesel'' as fuel. Indian Railways would be able to not only save on its rising fuel bill but also control the pollution level. Sulphur and lead emissions came down significantly when biodiesel was used (biodiesel used to the extent of 10 percent mixture with the conventional diesel). The Railways' annual fuel bill of Rs 3,400 crore for using diesel could be reduced by nearly Rs 300 - 400 crore per annum by using biodiesel. Ultimately, the percentage of biodiesel would go up to 15 per cent as per the accepted global norms. It has already signed a MoU with ministry of petroleum and natural gas to grow Jatropa at 500 acres on its track. Biodiesel can be produced from edible and non-edible oils through trans-esterification using ethanol or methanol. The properties of biodiesel are close to that of diesel fuel and in fact, it offers advantages in terms of emission control from diesel engines. In India the current assessments are based on non-edible oils for biodiesel production. Although methanol is preferred for transesterification world over, mainly due to cost advantage, but in India ethanol may be worth considering since we grow more of sugarcane. This green fuel has high octane and lubricity and readily mixes with diesel without any engine modification. And automobile manufacturers like Mahindra and Mahindra and Ashok Leyland have endorsed biodiesel as a fuel for their vehicles. It also scores in terms of availability and price. Biodiesel has already made headway in countries like US, European countries, Australia, Japan and Malaysia. Taking the lead Considering the scope of this new fuel, Mumbai-based Hindustan Petroleum Corporation Ltd (HPCL) has introduced biodiesel though a pilot project in association with Brihan Mumbai Electric Supply & Transport System popularly known as BEST in Mumbai. This joint project is mainly aimed at reducing the pollution levels in Mumbai. The project, first of its kind in urban transport, is in tune with HPCL's commitment to promote a clean and healthy environment. Commenting on the pilot project Ashish Chemburkar, chairman, BEST committee said, "BEST has 25 depots; runs 3340 buses in 800 routes; and consumes 6750 kilolitres of diesel per month. Due to our continued commitment to reduce pollution in Mumbai, we introduced environmentally friendly buses fitted with CNG engines. As a next step we have decided to go for biodiesel." DaimlerChrysler on Biodiesel Its not only the Indian organizations like railways and HPCL even the world's oldest automaker DaimlerChrysler, has embarked on a project to prepare biodiesel from the extracts of Jatropha plants as a viable alternative to the conventional energy. It has been working on the project in association with the Hohenheim University, Germany, and the Council for Scientific and Industrial Research of India. It had established two small plantations on eroded land in two climatic regions-Orissa (sub-humid region) and Gujarat (semi-arid area). These Jatropha curcas oil seed tree plantations were expected to recover eroded soils and render them usable for agriculture purpose again as well as to produce oil that could be used for biodiesel production. The five-year project was launched in 2003 and had been broadly divided into three phases. In the first phase a test drive of a Mercedes-Benz C-class car was run on the biodiesel for over 5,000 km and the results were encouraging in the reduction of pollution and the fuel's adaptability to different climatic conditions. MB Lal, chairman and managing director, HPCL who took up the initiative of launching biodiesel said, "Of the 25 buses selected for the pilot project, five buses run on normal diesel, five with five percent biodiesel blend, five with 10 percent biodiesel blend and 10 with 20 percent biodiesel blend. The trials are conducted on Euro II and Euro I buses. The smoke and other parameters of emission would be checked. The total quantity of biodiesel required for three months trial is 20,000 litres. The cost would be Rs 15.7 lakh. As of now we procure biodiesel from Lubrizol India Ltd made from non-edible oil of Karanjia. As per requests from BEST we are extending the project for six months." Besides HPCL, the research and development wing of Indian Oil Corporation (IOC) at Faridabad in Haryana is also exploring the possibilities of doping diesel with five percent biofuels (oil extracts from jatropa curcas, mahua, karanjia, sunflower seeds and rapeseeds). The IOC is also planning to launch a trial run of buses on biodiesel. For this the IOC is looking at Haryana Roadways. About 450 kilolitres of bio-diesel would be used in the pilot project. The necessary support The success of any program depends on the government's initiative, support and implementation of the policies. And fortunately this program has been endorsed and well supported by the government. Ram Naik, union minister for petroleum and natural gas of the outgoing cabinet had said, "The ministry of petroleum and natural gas is involved to the extent of blending biodiesel in diesel. We have already taken up the issue with the Bureau of Indian Standards and got the specifications of diesel modified to incorporate oxygen content of six percent thereby paving the way for blending of biodiesel. To stop poor quality of oils being passed off as biodiesel, standard specifications for the product are required to be formulated. This needs to be done before a large-scale biodiesel program takes off in the country." Even the Planning Commission has recommended setting up a national mission on biodiesel. A task force of the Planning Commission has proposed that oil extracted from the Jatropa curcas plant be mixed with diesel to bring down emission levels. Dr DN Tewari, who heads the task force, revealed that the diesel blend is estimated to cost Rs 14 per liter and will be EURO III compatible. It observed that the communities in Bastar in Chhattisgarh have been using this oil to run farm equipment and motorcycles for years. Studies indicate that this extract is superior to both petrol and diesel and engines need not even be modified to run on this fuel. The ministry of petroleum and natural gas has planned to adopt a strategy; first it has decided to start a pilot project at Mumbai (project launched last month) and Rewari in Haryana to see the impact of biodiesel-blended diesel on vehicles in Indian conditions. With the thrust given to the renewable fuels, former union minister Ram Naik observed, "the Indian agriculture will respond to the challenges and as with the green and white revolution. We will see a black revolution leading India to the path of self-sufficiency in oil. These fuels will benefit the farmers apart from reducing the foreign exchange burden on import of crude oil and also benefit the environment in major cities." The union ministry of rural development, the designated nodal ministry for the implementation of the program, has already initiated a scheme for the development of wastelands through plantation of trees and herbs having oil-bearing materials. The petroleum ministry has signed a MoU with the Indian Railways for encouraging plantation of Jatropa in 500-hectare area along the railway tracts. An avenue to look at The alternative fuel is not only eco-friendly but also provides a renewable source as it is extracted from a plant. Its use would help bring down the emission levels and re-deploy the surplus manpower and contribute to environment protection. The plant can easily be grown as it adopts itself well to arid, semi-arid conditions and demands low fertility and moisture. The other advantages are the fuel's contribution to national energy pool and the potential of job creation in the rural sector. The oil majors have already taken the lead in introducing biodiesel. The results of the pilot trials would give greater impetus to the program and contribute significantly towards the environment, agriculture, infrastructure development and job opportunities. The states-Rajasthan, Uttaranchal, Chhattisgarh, Gujarat, Madhya Pradesh - which used to reel under drought/ wastelands/ large biodiversity, have to look at biodiesel as a new avenue to attract investments. This will achieve livelihoods for millions and green cover for wastelands. It will be a win-win option for the state governments, firms and the common man. Narayan Kulkarni ]]> <![CDATA[Fresh impetus for European biotechnology]]> https://biospectrumindia.com/news/95/1925/fresh-impetus-for-european-biotechnology.html https://biospectrumindia.com/news/95/1925/fresh-impetus-for-european-biotechnology.html Thu, 10 Jun 2004 13:13:00 +0530 The European Commission presented a report on the implementation of the "Life Sciences & Biotechnology Strategy" adopted in 2002. The report highlights that progress has been made in the biotechnology sector players as well as the public and business stakeholders based on the EU action plan's recommendations. Highlights over the last 12 months include the launch of a high level advisory group on "Competitiveness in Biotechnology", the completion of an EU regulatory framework for Genetically Modified Organisms (GMOs) and initiatives to boost research and increase the number of scientists in the biotech sector. The progress report identifies upcoming issues, including genetic testing and animal biotechnology. This month the EU commissioners have granted a license for the importation and use of a GM maizeâ€”the insect resistant Bt11 variety from Swiss firm Syngenta. The move brings an end to the five-year moratorium on new approvals introduced in June 1999. Bt11 maize is already used in the EU in animal feed and processed products such as maize oil, having been approved under a previous body of legislation. The biotech lobby group EuropaBio considers the move as a positive signal for Europe. The corn, known as Bt-11 has been approved only for consumption, meaning Europeans will be able to eat the corn after it is imported from other countries but European farmers will still not be able to grow it themselves. The corn contains a bacterial gene that produces a toxin making the corn resistant to the corn borer and the corn earworm. The corn is also resistant to glufosinate, an herbicide. Biotechnology covers a wide range of powerful, but also sometimes controversial, technologies. It can make a vital contribution towards the long-term future of industries such as pharmaceuticals, food, agriculture, energy, textiles and chemicals. But success in developing biotechnology also depends on finding solutions to the significant ethical, societal, economic and environmental issues it throws up. The EU strategy provides a consistent approach to these challenges. In adopting the strategy, European leaders recognized that many decision-makers in both government and the private sector have to play a more active role in its implementation. This is now starting to happen in the member states. The process should be supported by the new "Competitiveness in Biotechnology" advisory group. The group, which includes business leaders and academics, is helping to identify issues affecting European competitiveness. Source: http://www.bba-bio.be  AusBiotech welcomes science and innovation package John Howard Australia's Biotechnology Organization (AusBiotech) welcomed the Federal Governments' $5.3 billion balanced science and innovation package announced by Prime Minister John Howard. The planned $1 billion Commercial Ready package will roll together programs and innovation access to provide a one-stop, continuum-support shop for small to medium enterprises, which will ensure global competitiveness. "This is a major and much needed win for boosting Australia's long-term sustainability and global competitiveness of the innovation and science industry," said Dr Anthony Coulepis, executive director, AusBiotech. "We are delighted and welcome the announcement by the Federal Government, which has addressed many of the elements that AusBiotech has been advocating for as a result of member consultation." "In particular, we are pleased that the Government has maintained its focus on biotechnology innovative industries by providing additional support to organizations such as the National Stem Cell Center and Biotechnology Australia. Enabling a grant-linkage support package will bring win-win partnerships for companies and academia," said Dr Coulepis. The Government plans to model this program on the process used for the P3 initiative. This will involve an intensive consultation process with key stakeholder groups and industry. AusBiotech is working closely with its members and stakeholders to assist the government with this consultation process. Source: www.ausbiotech.org  New program to give Israeli companies access to US bio hub Bill Musgrave A new program aims to make Israeli life science companies an active part of the business scene in the Silicon Valley area of Northern California. "The Bioentrepreneurial Bridge to Silicon Valley program will give Israeli companies access to Fortune 500 medical device and pharma companies as well as small and medium-sized enterprises looking for collaborations,"` said Bill Musgrave, CEO of TEN, adding that the program will also enable participants to meet local VCs "at a time when VC investment is on the rise again and life science deals are outpacing all other sectors." TEN, one of the leading business development and incubation organizations in the US, has graduated more than 300 companies during the past 10 years. Best known for launching the highly successful eBay portal, TEN currently is focusing on the life sciences sector and has recently inaugurated a major new nano-bio facility. The BioBridge program is being subsidized in part by the United States-Israel Science and Technology Foundation, enabling sections of the project to be offered for no charge or at a nominal charge. Agilent Technologies Inc., a global technology leader in life sciences, chemical analysis and other technologies will be one of the presenters at BioBridge 2004. Other US participants include BabyBio, Avigen, Burrill and other leading investors and life science corporations. Israeli participants include 20 early stage companies and incubators. The BioBridge project comprises three programs: videoconferencing sessions, an incubation program and business development activities. "The video conferencing sessions will be completely interactive between Israeli and US participants and both groups will feel like they are overseas," said Dr Adolfo Nemirovsky, Program Coordinator. The second component of the BioBridge program involves selecting two Israeli companies from those attending the videoconferencing sessions to be hosted at no charge for six months at the new TEN Bio-Nano Facility for Business Development Acceleration. TEN will provide the successful candidates with free office space and expert consultation. The consulting services (up to 100 hours per company) will include business model development and review; exposure to Silicon Valley and US business opportunities and investors, networking and mentoring support with critical sales efforts; facilitating partnering and fund raising; access to local university resources and student interns; network for business development matchmaking; access to service providers; turn-key office support; and a supportive, high-energy environment. The third component of the program involves selecting five companies from those attending the videoconferencing sessions to benefit from up to 100 hours of no charge consulting, including business development assistance, similar to that described above. Dr Nemirovsky expects the program, which is limited to 25 Israeli participants, to attract CEOs, business development executives and R&D directors at early-stage and emerging biotech, medical device and healthcare companies. This program will be held in May. "One of the advantages of having the program during May is that it will enable biotech participants to start networking and generate leads to follow-up at Bio 2004 in San Francisco in June," Dr Nemirovsky noted. The BioBridge Program is being coordinated in Israel by BioIsrael. Source: www.bioisrael.com  Israel, China to jointly develop hybrid crops The China National Hybrid Rice Research and Development Center and the Israel's FertiSeeds have decided to work together to develop super hybrid crops. The two organizations hope that the hybrid seeds based on FertiSeeds technology will promote the economical production of seeds that will significantly improve yield and quality in major crops as rice and cotton. Fertiseeds Ltd operates in the agricultural biotech field and offers a universal solution for producing high yield hybrid seeds based on a revolutionary "green" molecular genetic technology. This technology promises to revolutionize production of hybrid seeds for key food crops, animal feed and fibers. The technology places genes in a plant genome so the offspring will produce 100 percent hybrid seeds. The resultant hybrid plant will show high yields and other hybrid-vigor related characteristics. Prof. Yuan Longping, director of the China National Hybrid Rice Research and Development Center said that the joint testing by his center and Israel's FertiSeeds to develop super hybrid rice is a pilot effort. It will take at least five years to market the technology developed in the experiment, he added. Dr. Vered Yesodi, chief executive officer of the private agro-biotechnology company FertiSeeds, expressed his confidence that the new technology will develop high-yield rice hybrids and related technologies for China. He said that this cooperation is the first of its kind between the two countries. Yuan, 74, who is known as the father of hybrid rice in China, shared the 2004 Israeli Wolf Prize in Agriculture with Professor Steven Tanksley of Cornell University, US. Israeli President Moshe Katsav awarded the prize to Yuan in Jerusalem. Source: China Daily New Zealand, Queensland work together for growth of biotechnology There is a real opportunity for New Zealand and Queensland to work together and build a formidable Australasian biotechnology industry by 2010, reported a task force appointed by New Zealand to research on an action framework for growing the biotechnology sector. The task force noted that both the countries already have strong and often complementary research strengths, competitive R&D costs, outstanding natural resources and magnificent environments. Besides both the countries have all the ingredients required to make major contributions to human health and agricultural biotechnology. To achieve this, the task force observed, the countries need to identify biotechnology and particularly agricultural biotechnology, as a key driver for future growth. They also need to build their skills in bioentrepreneurship and further strengthen them by developing mutually supportive links between the managers of New Zealand and Queensland biotechnology companies. Additionally there is also a need to secure substantial public and private investment in a combined New Zealand/Queensland biotechnology fund ensuring that the full potential of the emerging biotechnology industries is achieved. The task force also made recommendations to increase focus on agricultural biotechnology, attract, train and retain the competent technology managers and establish a Trans-Tasman venture capital fund aimed at generating, with appropriate private sector leveraging, a total of $500-1000 million in about five to seven years. The report was commissioned to explore collaborative opportunities between New Zealand and Queensland in the field of biotechnology. Source: http://www.industrytaskforces.govt.nz/ Biotech business and academic groups unite under FlandersBio The academic and business groups of biotechnology in Flanders have been united under an umbrella organization named FlandersBio, in an effort to continue sustained growth of the sector in the region. The first president of the organization is to be Staf Van Reet, a former President of the Janssen Research Foundation and CEO of Janssen Pharmaceutica who currently represents the Johnson & Johnson Development Corporation and the Johnson & Johnson Office of Science and Technology in Europe. About 40 biotech companies have confirmed their participation in the FlandersBio initiative, according to the Flanders Interuniversity Institute for Biotechnology (VIB), a non-profit scientific research institute that groups biotech research at universities in the region. Along with VIB, the other major Flemish biotech companies and financiers which have collaborated in the creation of FlandersBio are 4AZA Bioscience, Bayer BioScience, Innogenetics, Life-Sciences Group, Methexis Genomics, Thromb-X, Tibotec, Tigenix, Virco, BIP, Capricorn Venture Partners, GIMV, and Johnson & Johnson Development Corporation. The aim of FlandersBio is to stimulate the flow of technological and non-technological knowledge among the biotech players, raise the international profile of the Flemish biotech sector and build the favorable environment in the region for the development of companies in the sector. Flanders is ranked the third in Europe for the number of biotech patent applications per million inhabitants. Supported by an array of investors, a unique network of technology transfer offices, attractive investment incentives and a dedicated government, life sciences and biotechnology ventures will further flourish in Flanders. Top 40 Locations for Biotechnology in the US 1 New York-Northern New Jersey-Long Island (NY- NJ-CT-PA CMSA) 2 Boston-Worcester-Lawrence (MA-NH-ME-CT CMSA) 3 San Francisco-Oakland-SanJose (CA CMSA) 4 San Diego (CA CMSA) 5 Los Angels-Riverside-Orange County (CA CMSA) 6 Philadelphia-Wilmington-Atlantic City (PA-NJ- DE-MD CMSA) 7 Raleigh-Durham-Chapel Hill (NC MSA) 8 Washington-Baltimore (DC-MD-VA-WV CMSA) 9 Chicago-Gary-Kenosha (IL-IN-WI CMSA) 10 Seattle-Tacoma-Bremerton (WA CMSA) 11 Houston-Galveston-Brazoria (TX CMSA) 12 Detroit-AnnArbor-Funt (MI CMSA) 13 Pittsburgh (PA MSA) 14 Atlanta (GA MSA) 15 Denver-Boulder-Greeley (CO CMSA) 16 Dallas-Fort Worth (TX CMSA) 17 St Louis (MO-IL MSA) 18 Minneapolis (IN MSA) 19 Indianapolis (IN MSA) 20 Cleveland-Akron (OH CMSA) 21 Nashville (TN MSA) 22 Columbus (OH MSA) 23 Miami-Fort Lauderdale (FL CMSA) 24 Greensboro-Winston-Salem-High Point (NC MSA) 24 Sacramento-Yolo (CA CMSA) 26 Rochester (NY MSA) 27 Tampa-St Petersburg-Clearwater (FL MSA) 28 Cincinnati-Hamilton (OH-KY-IN-CMSA) 29 San Antonio (TX MSA) 30 Portland-Salem (OR-WA CMSA) 31 Salt Lake City-Ogden (UT MSA) 32 Memphis (TN-AR-MS MSA) 33 Oklahoma city (OK MSA) 34 New Orleans (LA MSA 35 Hartford (CT MSA) 36 Milwaukee-Racine (WI CMSA) 37 Austin-San Marcos (TX MAS) 38 Providence-Fall River-Warwick (RI-MA MSA) 39 Kansas City (MO-KS MSA) 40 Buffalo-Niagara Falls (NY MSA) Source: www.facility.com             ]]> <![CDATA[Dr Suman Sahai honored with Borlaug Award 2004]]> https://biospectrumindia.com/news/95/2036/dr-suman-sahai-honored-with-borlaug-award-2004.html https://biospectrumindia.com/news/95/2036/dr-suman-sahai-honored-with-borlaug-award-2004.html Sat, 15 May 2004 17:20:00 +0530 Dr Suman Sahai, who has had a distinguished scientific career in the field of genetics, has been honoured with Borlaug Award 2004. After her PhD degree from the Indian Agricultural Research Institute, New Delhi, she served on the Faculties of the Universities of Alberta in Canada, Chicago in the US and Heidelberg in Germany from 1981 to 1989. Dr Sahai returned to India in 1989 and organized Gene Campaign, a non-governmental organization dedicated to fostering genetic and trade literacy among farmers and the general public. Gene Campaign has been at the forefront of generating awareness on issues relating to trade, intellectual property rights and genetic resources conservation and sustainable use. Dr Sahai has been working both at the grassroots and policy levels, with great dedication and considerable impact. She is member of several national policy forums on environment, biotech and intellectual property rights as well as education and health. Praj Industries CMD receives JMCCI Award Pramod Chaudhari, chairman and managing director of Pune-based Praj Industries, received the Jagatik Marathi Chamber of Commerce & Industries (JMCCI)'s "National Level Entrepreneurship Award" from Mohammad Fazal, Governor of Maharashtra recently. This award was in recognition of not only his "entrepreneurship" but also his achievements in taking Praj, an Indian company, into the "global arena" through innovation of biotechnology-led processes for renewable sources of energy like ethanol. He has been actively promoting the concept of Indian engineering and biotechnology exports at various global forums. NIPER Professor gets Bioscience Award Prof. Chinmoy Sankar Dey of National Institute of Pharmaceutical Education and Research (NIPER) has been awarded the National Bioscience Award 2003-2004 by the Department of Biotechnology, Government of India. The award, which carries a cash prize of Rs 1 lakh, a research grant of Rs 9 lakh for three years, and a citation, is given by DBT to recognize the outstanding contributions of young scientists in basic and applied research, covering all areas of biosciences. Dr Dey has been awarded for his contributions in target-based screening technology against insulin resistance as well as for his research on focal adhesion kinase in skeletal muscle. ]]> <![CDATA[Biotech Training Programs]]> https://biospectrumindia.com/news/95/4947/biotech-training-programs.html https://biospectrumindia.com/news/95/4947/biotech-training-programs.html Sat, 15 May 2004 17:20:00 +0530 A short-term training program during or after a biotechnology degree helps in orienting students to adapt to the needs of the biotech industry. Several biotech company heads felt that hands-on training gives an edge to the prospective candidates during the selection process, though it is not an essential selection criteria. It also helps them to accelerate their career opportunities. We have also received many queries from students on this subject. Here are a few courses offered by the biotech industry/institutes. Government sponsored programs As part of its human resource training program the Department of Biotechnology facilitates postgraduate biotechnology training in industries. Students passing out of the postgraduate courses (MSc/MTech) in biotechnology are selected for practical hands-on training in various biotech-based industries in the country for a period of six months. This scheme is being implemented through the Biotech Industrial Training Program (BITP) of the Biotech Consortium India Ltd. (BCIL), New Delhi. The objective of BITP is to provide practical exposure to candidates who wish to start their career after post-graduation but do not have the requisite experience in biotechnology. This program orients them to the needs of the industry and makes them more relevant and acceptable for placement. The program is launched every year generally in the months of July/August. For, further details visit: www.biotech.co.in Many of the CSIR institutes offer regular training programs for postgraduate students under MoU with universities and also provide ad-hoc summer training to biotech students. Some of the other training programs offered by the educational institutes/industry are given below. Bangalore Genei's programs Bangalore Genei, a Bangalore-based key manufacturer and supplier of reagents for genetic engineering and molecular biology research, offers hands-on training in molecular biology/immunotechniques. It has two basic training programs in Recombinant DNA Technology Protein Purification and Immunotechniques. The company also offers a combination program covering both the topics. All the programs include lectures, discussions and bench work for 8-9 hours a day conducted by its scientists. Address: No. 6 6th Main, BDA Industrial Suburb, Near SRS Road, Peenya, Bangalore-560 058, Tel.: (080) 28391453/28396894 Website: www.bangaloregenei.com Best Biotek offers varied biotech training programs Best Biotek Research Labs has designed many biotechnology-training programs ranging from proficiency courses to advanced diploma courses in industrial microbiology, enzymology, protein chemistry, molecular biology, analytical techniques like HPLC and GLC. The duration of the courses vary from 15 days to 210 days. Address: #221, 2nd Floor, 9th Main, 5th Block, Jayanagar, Bangalore â€“ 560 041 Tel.: (080) 56903079/ 26632175 Website: www.bestbiotek.com DOEACC bioinformatics courses DOEACC Society, an autonomous body of Department of Information Technology, Ministry of Communications & Information Technology, recently introduced Bioinformatics Courses at various levelsâ€”O, A and B Level. To be implemented at a national level, these bioinformatics courses are in line with the DOEACC computer courses. The O and A level training started in July 2003 in 12 locations of DOEACC across India. This scheme is being implemented through the private sector from July 2004. Address: Electronics Niketan, 6 CGO Complex, New Delhi - 110 003 Tel.: (011) 24363330-2 Website: www.doeacc.org.in IBAB certificate course in Bio-techniques Bangalore-based Institute of Bioinformatics and Applied Biotechnology (IBAB) conducts a six-months course in the frequently used biotech lab techniques. These include handling bacterial culture, protein purification and analysis, recombinant DNA technology, microarrays, etc. IBAB also conducts several short-term courses in biotechnology and bioinformatics ranging from one day to a few days. In addition, the institute conducts tailor-made bioinfo-rmatics training programs for the corporate sector. Address: G-05, Tech Park Mall, International Technology Park, Whitefield Road, Bangalore -560 066, Tel.: (080) 28410029, 28412769. Website: www.ibab.ac.in IIT Delhi offers summer training in biotechnology The Department of Biochemical Engineering and Biotechnology, IIT Delhi has recently started conducting a short-term practical training course in biotechnology. This year the course starts from June 1 and is of five weeks duration. The course aims to provide exposure to some of the modern experimental tools and protocols of biochemical engineering and biotechnology to students of MSc (Biotechnology) and BTech (Chemical/ Biochemical Engineering). Address: Indian Institute of Technology, Delhi, Hauz Khas, New Delhi -110 016, Tel.: (011) 26591737. Website: www.iitd.ernet.in IIT Delhi and NIIT certificate programme The Supercomputing Facility for Bioinformatics & Computational Biology, IIT Delhi, in association with NIIT under the aegis of Foundation of Innovation and Technology Transfer (FIIT) at IIT, Delhi, has launched a six-months certificate programme in Bioinformatics & Computational Biology. The program addresses requirements in both IT and Bioinformatics training. The IT modules are offered at NIIT and the bioinformatics modules at the Supercomputing Facility of IIT Delhi. The Programme starts in June 2004. Address: Supercomputing facility, IIT Delhi, Tel.: (011) 26596786 Website: www.netvarsity.com/nv000/iitmain.asp IAHS plant tissue-culture training The biotechnology division of Indo American Hybrid seeds (IAHS), a company engaged in the production and marketing of hybrid seeds in vegetables, flowers and agronomic crops, offers technical training in advanced methods of plant cell and tissue culture and r-DNA technology for BSc and MSc biotechnology students. The course duration is about a month for BSc and 2-4 months (including project work and dissertation) for MSc students. IAHS conducts the training in three batches around the year in the months of April, May and October. The IAHS biotech division is also a center for the Biotech Industrial Training Program (BITP) of the Biotech Consortium India Ltd (BCIL), New Delhi. Under this program, it provides extensive plant tissue culture training to 2-3 biotechnology postgraduate students for a period of six months. Address: 17th Cross, 2nd 'A' Main, KRRoad, Banashankari 2nd Stage, Bangalore - 560 070 Tel.: (080) 26760111 Website: www.indamseeds.com JIVAS' diploma courses in biotechnology Jain Institute of Vocational and Advanced Studies (JIVAS), Bangalore, a division of Jain Group of Institutions is offering a range of job-oriented courses in biotechnology. At the graduate level it is offering: Proficiency course in genetic engineering; Diploma in plant tissue culture; Diploma in human molecular genetics; Diploma in industrial biotechnology; Comprehensive training in micro propagation At the post graduate level it is offering advanced postgraduate diploma in biotechnology; and postgraduate diploma in medical microbiology and immunology. The institute also offers customized projects for BSc/MSc students Address: No. 127/3, Bull Temple Road, Chamrajpet, Bangalore â€“ 560 019 Tel.: (080) 26604993/26525246 Website: www.jivas.ac.in Magene offers modern biotechnology training module Magene Life Sciences, a biotechnology research and bioservices oriented company located in the Genome Valley, near Hyderabad provides an integrated, interdisciplinary basic as well as advanced training course for students in biotechnology. The basic three weeks course is designed to include hands-on-training, GLP and introduction to modern biotechnology. The advanced module of two weeks duration is offered to post graduates for hands on training to support their core capabilities for further research. The company also offers a week long corporate training module tailor made for marketing, finance and management professionals working with biotech and allied industries. Address: Research Center, Pudur Post, Raval Kole X Roads, Medchal Mandal, Hyderabad Tel.: (8418) 222384/225449 Website: www.magenelifesciences.com Ocimum offers PGDiploma in Bioinformatics Ocimum Biosolutions, a Hyderabad-based bioinformatics company, offers a Postgraduate Diploma Program in Bioinformatics in association with University of Alabama at Huntsville. The duration of the course is six months. The program helps students, who usually have expertise or a degree in either life sciences or computer science, to be cross-trained. Address: 6th Floor, Reliance Classic Road No. 1, Banjara Hills Hyderabad - 500 034 Tel.: (040) 55627200 Website: www.ocimumbio.com Padmashree Institute provides diploma in Plant Tissue Culture Padmashree Institute conducts a short-term diploma in Plant Tissue Culture and Secondary Metabolite production. This seven-day course is open for graduates in Life Sciences. The course covers the basic techniques in plant culture, organ and embryo cultures, callus and suspension cultures, etc. Address: Nagarbhavi Circle, Bangalore â€“ 560 072 Tel.: (080)-23211099/23217664 Website: www.padmashree.org STG certificate/diploma courses in Bioinformatics The Software Technology Group International Ltd offers certificate courses in bioinformatics with domain specialization (pharma, agri or biotech) for graduate and postgraduate students. It also offers a six-months diploma course in bioinformatics. Address: 32 & 31/1, Khaleel Plaza, RV Road, Basavangudi, Bangalore â€“ 560004 Tel.: (080) 26574553/26574554 Website: www.stgglobal.com ]]> <![CDATA[The biotech community speaks...]]> https://biospectrumindia.com/news/95/1599/the-biotech-community-speaks.html https://biospectrumindia.com/news/95/1599/the-biotech-community-speaks.html Wed, 12 May 2004 16:22:00 +0530 views Future prospects of biotechnology in India "There are several segments, which have good prospects for the growth of biotechnology in the country. Health and agriculture are two promising areas. In the last two to three years, we have had good signs of growth in these segments. But the next five years will be crucial for the biotech industry. There are some societal aspects that require proper attention. Areas like vaccines, bio therapeutics and diagnosis hold good potential for the development of the entire biotech industry. There are some areas that are yet to be explored even though we have expertise in those areas. Among these, immunotherapeutics offers a great opportunity for development. We, as a nation, need to focus on this area and come up with something good." Dr MK Bhan Secretary, Department of Biotechnology On the need of a clinical data management course "India can become a major hub for clinical trials in the world. We have enough biodiversity available here. We have a very good hospital system. Many hospitals are interested to have a tie up with research organizations of the western world and many people are exposed to newer drugs and they want to do the clinical trials. What we require is a proper channel for collecting the data, organizing and analyzing the same. The problem we are facing is collection of data and how to organize it. Today if we see, clinical data management is not included in any syllabus. It needs to be put in an organized way." Prof. AS Kolaskar, Vice Chancellor, University of Pune On biotech education in India "These were some government initiatives, which have served the country very well. But now the tendency is a mushrooming of biotechnology courses in the country without proper quality and infrastructure, because the name biotechnology sells. This is something that has to be attended to. I think that we do not have quality control on many of the courses started by the university unlike the DBT courses. Indian scientists and researchers are a very large reservoir of trained manpower but in the name crass commercialization we are systematically destroying the system that has helped them evolve. This is a matter of grave concern." Prof. M Vijayan, Associate Director, IISc, Bangalore Potential of biotech industry "The beauty of the biotechnology industry is that it has multifaceted requirement unlike software industry, which needs only homogenous skill. A company like ours has biologists, chemists, genetic scientists, microbiologists, mechanical, chemical, electrical engineers, regulatory people, doctors, lawyers and so on. This shows the huge potential of the industry in generating various kinds of jobs." Ms Kiran Mazumdar-Shaw Chairman and Managing Director, Biocon Human resource development in food biotech "CFRTI offers a masters course (MSc) in food technology, which teaches a lot of biotechnology. The course incorporates investigational problems, which are biotech oriented. This degree program gives a tremendous amount of input to the students so that they go back to industry, work there and introduce the concept of biotechnology. The institute also has PhD students working in the different departments and about 1/3 of them (100 plus) are working on biotechnology in one-way or the other. We also have short-term courses, where we have the industries and entrepreneurs coming in. But, I would like to emphasize on their quality. Quality is nothing but knowledge and skill combined with the art of doing things with innovation. The quality of education at CFTRI should be a good benchmark for others to follow. Our food technology graduates are # 1in the country, and perhaps in the SouthEast Asia region also." Dr V Prakash Director, CFTRI, Mysore Government research institutes vs the private sector? "Government institutes and the Indian private sector establishments span a wide range in terms of facilities. But the best government organizations offer facilities superior to the best private sector establishments at present. Moreover, government organizations like CSIR have a large network, which enables optimal utilization of pooled resources. Growth prospects have traditionally been better in private organizations but with the increasing trend to break out of time bound promotion patterns; the trend is likely to change. Salaries are relatively lower in government organizations but the freedom and creativity nurtured, factors, which are very critical in research, by the environment in a young and growing research institute like IGIB still attracts the best talent." Dr SK Brahmachari, Director Institute of Genomics and Integrative Biology (IGIB), New Delhi About current generation biotech researchers "Though there is a general feeling that Indian science is going down but in modern biology and biotechnology first class research is going on in India. Researchers are publishing papers in high impact international journals. Thanks to government support especially the Department of Biotechnology that has promoted research by establishing centers, infrastructure and national facilities all over India. This is showing up today. Excellent science is going on." Prof G Padmanabhan Distinguished biotechnologist, Honorary professor, Indian Institute of Science, Bangalore Synergy between government research institutes and the private sector "The concept of R&D based pharma sector is fast picking up and private sector has invested in basic research for the discovery and development of new drugs. However, only a few disease areas are covered by these pharma companies as their selection is directed solely by the market size and business opportunities. The priorities of government institutions especially a drug research laboratory are driven more by societal welfare and knowledge contribution. Such institutions are therefore not only centers of excellence but also provide centralized infrastructure to cater to the practical skill development of students and mid-career professionals." Dr CM Gupta Director Central Drug research Institute (CDRI), Lucknow Future of BioPharma "A biotech drug has no chemical substitute. Biotechnological drugs are in a much better position to establish the kind of therapeutics that are required. There is no treatment in those areas. When I started it appeared to me that in 10-15 years it is going to become more and more important. That is what is happening now." Habil Khorakiwala Chairman and Managing Director, Wockhardt Ltd Opportunities in the clinical trials area "The job categories could be multifaceted like coordinator, monitor, research associate, clinical research physician, trial materials manager, project manager, medical writers, data managers, data entry persons, lab technicians etc. The field requires postgraduates in the relevant field with a scientific background and bent of mind for clinical trials." Rajiv Gulati Managing director and chairman, Eli Lilly and Company (India) Pvt Ltd, Gurgoan On human resource "The biotech industry is a highly knowledge-intensive one and human resource is its prime asset and strength. Quite like the IT sector was in the early 90's, the biotech sector too is witnessing a lot of hype leading to expectations and is definitely a sunrise sector for any job-seeker. Hence, there is demand for qualified and experienced personnel. For the R&D job seeker, what is needed is the right exposure to the scientific way of working and the mindset to experiment and innovate. And patience to see R&D translate into commercial success." Varaprasad Reddy Managing Director, Shantha Biotech, Hyderabad New entrants in this field should haveâ€¦ "We look for scientific performance, novel ideas, integrity, ability to provide leadership, ability to work in a team, desire to achieve goals in shortest-time possible and desire to apply the scientific knowledge into human cause." Dr Lalji Singh Director Center for Cellular and Molecular Biology (CCMB), Hyderabad Fusion of ancient wisdom and modern sciences "India can develop world-class products by fusing ancient wisdom and modern sciences because new products cannot compete with products, which have only tradition and empirical observation as the knowledge base. The knowledge to be integrated into the traditional products has to emerge from modern science, especially modern biology and chemistry. Such fusion will lead to better definition of existing products, improved understanding of the mechanism of their action, modified composition at molecular level and better understanding of interactions amongst various molecules." Dr RA Mashelkar Director General, CSIR ]]> <![CDATA[Entry Points]]> https://biospectrumindia.com/news/95/1042/entry-points.html https://biospectrumindia.com/news/95/1042/entry-points.html Wed, 12 May 2004 16:18:00 +0530 For structured formal training in the subject today, one can choose biotechnology as the area of specialization at the graduation, post graduation or research level. Being an interdisciplinary field, higher education in biotechnology does not necessarily call for a prior degree in the same subject. For instance, if someone wants to do MSc (Biotechnology), then it is not essential for him to have a bachelors degree in biotechnology. Earlier, the biotech stream was offered only at the postgraduate level. But today due to the increasing popularity and awareness of biotech, some universities/private colleges have introduced biotech at undergraduate level (BSc Biotechnology).  Bachelors Degree Program  A few of the universities like Bangalore University (Karnataka); Chaudhary Charan Singh University, Meerut, (Uttar Pradesh); Kakatiya University, Warangal (Andhra Pradesh); Madras University, Chennai (Tamil Nadu); Osmania University, Hyderabad (Andhra Pradesh); and Patna University, (Bihar) have BSc (Biotechnology) course. Several others are likely to introduce these courses. The eligibility criterion is essentially 40 percent (the minimum percentage may vary from state to state) in PUC/10+2/Intermediate/equivalent with science subjects. The duration of the course is three years and admissions are either through an entrance exam or percentage based. BSc Biotech is a new concept, but many prestigious institutes have been offering a four-year BTech course in Biotechnology for quite some time. For example, IIT Kharagpur offers a BTech degree program in Biotechnology and Biochemical Engineering while IIT Chennai and Gawahati give a BTech degree in Biotechnology. Similarly IIT Delhi and Kharagpur offer a five-year dual degree MTech course (After completion of 10+2) in Biochemical Engineering & Biotechnology where as IIT Chennai offers a similar MTech course in Biotechnology. Admission to these IIT undergraduate programs is through an all India competitive examâ€”the Joint Entrance Examination (JEE). The minimum qualification for admission through JEE is a pass grade in the final examination of 10+2 system or its equivalent. Besides the IITs, several other institutes and universities offer a BE/BTech Biotechnology course. The Anna University in Chennai has been offering a BTech program in Industrial Biotechnology since 1992. Some other universities offering BTech (Biotechnology) courses include Bharathidasan Institute of Engineering and Technology, Tiruchirappalli; Guru Gobind Singh University, Delhi; Guru Nanak Dev University, Amritsar (BTech Chemistry and BioEngineering); UP Technical University, Lucknow; Vellore Institute of Technology, Vellore (Tamil Nadu). This is just a representative list. Students who have completed 10+2 with a science background are eligible. Students are selected either through the All India Engineering Entrance Examination (AIEEE), or the common entrance exam conducted by the state governments. Masters Degree Program A major thrust in the area of biotech education has come from the government. The Indian government set up a separate Department of Biotechnology (DBT) under the Ministry of Science & Technology in 1986 to give impetus to the development of modern biology and biotechnology in India. In the last 18 years of its existence, DBT has promoted and accelerated the pace of development of biotechnology in the country. As part of that mandate, it encourages and supports postgraduate teaching programmes in the country. This to create trained human resource at the post-graduate level in general biotechnology and different specialized branches like agriculture biotechnology, medical biotechnology, marine biotechnology, neurosciences, biochemical engineering and biotechnology. Currently, through several universities spread all across the country, it supports 27 MSc courses in general biotechnology, seven in agriculture biotechnology, one in medical biotechnology, two in marine biotechnology, and six MTech courses in biochemical engineering, bio-process technology and biotechnology. In total, it supports about 60 courses. The total intake of students through all the postgraduate courses is around 840 per year. Students are admitted to different universities through an All India combined entrance examination, conducted by Jawaharlal Nehru University (JNU), New Delhi (on behalf of Department of Biotechnology) in May. DBT offers MTech Biotechnology program (2 year/4 semester) through Anna University, Chennai (Tamil Nadu) and University of Technology, Kolkata (West Bengal). Candidates who have done B Pharma or BTech/BE course (biotechnology or related disciplines) or MSc life sciences are eligible for this program. Admissions are either through the joint entrance exam conducted by JNU or through GATE. The Birla Institute of Technology (BITS), Pilani, also offers a ME degree in biotechnology. In addition to the DBT supported postgraduate courses, many universities, private colleges and institutes are also offering masters program in biotechnology. Anyone wanting to opt for this course should have a BSc degree with a minimum of 50 percent aggregate marks (this percentage may vary from state to state) with chemistry or biochemistry as a compulsory subject and any one optional subject like botany, applied botany, zoology, environmental science, sericulture, biotechnology, and genetics. The admissions are either percentage based or through an entrance exam conducted by the university. There have been other initiatives too. For instance, The University of Pune launched a unique two-year fulltime MBA program in biotechnology. This is the first such program by an Indian university or institute and probably the first in Asia too. The program admits 60 students each year. The syllabus is based on the requirements of the industry. 60 percent of the syllabus covers the managerial aspect and about 40 percent biotechnology. Bioinformatics Courses Bioinformatics, which is an offshoot of biotechnology, has been lately attracting a lot of attention. This has led to specialized BSc/MSc and BTech courses in this branch. Like the Guru Gobind Singh Indraprastha University has been offering a BTech course in bioinformatics since 1999. Bharathiar University and Pune University offer a two-year MSc courses in bioinformatics. DBT offers Advanced Diploma in Bioinformatics (1-year course) in five Indian universitiesâ€”Calcutta University, Jawaharlal Nehru University (New Delhi), Madurai Kamaraj University, Pondicherry University and Pune University. The intake for these courses is based on All India Entrance Exams that are conducted by the respective centers. Apart from the DBT conducted courses, Bangalore-based Institute of Bioinformatics and Applied Biotechnology offers a 16-month postgraduate diploma course in bioinformatics. The Bioinformatics Centre (BIC) at Jawaharlal University, New Delhi, offers a PhD program in bioinformatics. In the past few years, many private institutes have also started offering BSc/MSc Bioinformatics courses like Noida based Bioinformatics Institute of India, Delhi-based Amity Institute of Biotechnology, and The Jay Pee Institute. PhD Programs Basic research is of significance to all aspects of modern biology. India has a large network of research institutes spread around the country established both by government and private sector. These have a thrust on biotechnology too. Students wanting to pursue an active career in biotech research can enter any CSIR, ICAR or ICMR lab depending on their qualification and area of specialization. The basic qualification required is a post graduation degree with a CSIR/ICAR fellowship and/or a good GATE score. CSIR The Council for Scientific and Industrial Research (CSIR), the government body to promote scientific research has a network of 40 laboratories and 81 field stations/extension centers/regional centers all over India to undertake R&D in several disciplines including biotechnology. It currently employs more than 22,000 highly qualified multidisciplinary professionals. CSIR holds the national level joint CSIR-UGC Examination (NET) normally twice every year, one in June and another in December. This examination determines the eligibility of Indian nationals for the award of Junior Research Fellowships (JRF) and for appointment of lecturers. ICAR ICAR promotes science and technology programs in agricultural research and education and carries out research directly through ICAR institutes and national research centers, project directorates and also in association with the State Agricultural Universities (SAUs) through the all India coordinated research project systems. This vast network of ICAR has manpower of about 30,000 personnel out of which nearly 7,000 are engaged in active research and its management. 30 SAUs employ about 26,000 scientists for teaching, research and extension education; of these over 6,000 scientists are employed in the ICAR supported coordinated projects. The Agricultural Research Services (ARS)/National Eligibility Test (NET) examination is conducted by Agricultural Scientists Recruitment Board (ASRB) (Krishi Anusandhan Bhavan, Pusa, New Delhi) for filling up vacancies of scientists of the ARS institutes, the ICAR institutes and for recruitment of lecturers and assistant professors by the State Agricultural Universities (SAU). ICMR The Indian Council for Medical Research (ICMR) formulates, coordinates and promotes biomedical research in India. Its network consists of 21 permanent research institutes/centers (national institutes) located in different parts of India and six regional medical centers. The ICMR national institutes offer opportunities for research in the area of medical biotechnology. Apart from the labs falling under CSIR/ICAR, almost all the IITs, institutes and universities having a life/biological sciences department offer scope for research in biotechnology. Admission to these PhD programs is made on the basis of written test/interview conducted by the department/centre concerned. In order to train scientists in frontier areas of research in biotechnology, DBT introduced a Postdoctoral Fellowship Program in 2000. The Bangalore based Indian Institute of Science (IISc) engaged in major biotech research activities coordinates and implements this program. This fellowship is for two years and aspirants holding a PhD degree in Science, Engineering or MD degree in medicine with research interests in Biotechnology and Life Sciences are eligible. The program has recently been restructured and expanded to cover more universities and R&D institutions. IISc conducts both PhD and integrated PhD programs (directly after BSc) in biological sciences, which includes research in biotechnology also. The Indian educational system offers a multi route channel for students to enter the biotechnology arena. There is no dearth of training opportunities and all that a student requires is hard work, dedicated outlook and an analytical approach to make a mark in this field. (Log on to www.amity.edu/aib for detailed list of the universities/institutes/colleges offering biotechnology and related courses). ]]> <![CDATA[Engineering a New Future]]> https://biospectrumindia.com/news/95/2609/engineering-a-new-future.html https://biospectrumindia.com/news/95/2609/engineering-a-new-future.html Wed, 12 May 2004 16:15:00 +0530 bio student Engineering a New Future Medical and engineering were the sole premier career choices for several years now. However, during the last five years or so, there have been several attractive alternative careers. Biotechnology is one among the new career options. With the Indian biotech industry in an expansion mode, a career in biotechnology is not just attractive but challenging and rewarding too. A question on career aspirations from any bright budding science student would more often than not, till the recent past, elicit the standard doctor or engineer reply. This was partly due to an innate urge to be associated with these professions but importantly also due to dearth of other options. Though these still remain a popular career choice, but now a student can choose from a range of equally attractive options, like biotechnology. One can argue that scientific research in this area of life sciences always existed and this is nothing new except that now it is bundled together under the new name of "biotechnology". But what one misses is while the research findings were earlier only of academic interest but now they have the potential to transform into excellent business opportunities. This has made biotechnology an attractive alternative career to the conventional engineering and medical sciences. Indian biotech industry Biotechnology in India is a "sunrise industry" which is still nascent and growing. Biotech based knowledge has found applications in the agriculture, pharmaceutical, informatics etc. This emerging industry in India was worth Rs 2,305 crore during 2002-03 (BioSpectrum estimates). This includes the biopharma, bioagri and bioindustrial products, bioinformatics market, the clinical trials and contract research services segment and the suppliers business. According to industry sources, of the various segments, the biopharma accounted for the largest market share (about Rs 1,275 crore). Then comes the biosuppliers' segment followed by the industrial, services, agricultural, and informatics sector in that order. The Intellectual Engine 40 National Research Institutes 15,000 Scientists 300 Life Science Colleges 500,000 Gradutes Per Annum 120 Medical Colleges 17,500 Medical Gradutes Per Annum 200 Biotech Companies Employing 6,000 Scientists in R&D 100 Teaching Hospital Employing Medical & Paramedical Professionals Given the above statistics, does this field constitute a serious long-term career option? The answer is a definite "yes". According to Prof. G Padmanabhan, distinguished biotechnologist and Padma Bhushan awardee and honorary professor Indian Institute of Science, "At this juncture, the biotech industry has just crossed the lag phase and is at the start of the log phase. We have a long way to go but the path is exponential now." His words are substantiated by the trends seen in the industry. It is in a consolidation phase today and is investing heavily in setting infrastructure and in research and development activities. The total investment during 2002-03 was about Rs 120 crore more than in 2001-02 and this is expected to double in the next two years. Another pointer in this direction is that the manpower employed during the year (2002-03) grew by 68 percent over that in the previous year to 6,400! PAIRS Factor Biotechnology is gaining prominence in India and the world over with many research institutions, university departments and corporate sector companies engaging in biotech research activities. In India alone there are over 200 research institutes and universities involved in biotech research. And there are more than 150 private sector companies working in different segments of biotech research, manufacturing and marketing. Biospectrum terms it as the PAIRS opportunityâ€”Pharma, Agri, Informatics, Research, and Services. Talking about the scope of the largest segment in the biotech industryâ€”BioPharma, Dr SD Ravetkar, senior director, Serum Institute of India, Pune said, "The potential for this sector is huge. With the implementation of WTO and patents regime in 2005 Indian companies would not be able to backward engineering of the products, so they are focusing on in-house R&D. The growth prospects are bright as a large number of foreign pharma companies are setting their R&D units here." According to Dr William A Haseltine, founder and former chief executive officer, Human Genome Sciences, "Each pharma company has phase I and II compounds and they are desperate for products. And this is where the biotech companies come in." He has been a pioneer and contributed significantly to the use of genomicsâ€”the study of all human genesâ€”to develop new pharmaceutical products. He has immense faith in the methods of treating and curing diseases by bringing new gene-based products to patients around the world. Dr Haseltine explained the logic for the importance of biotech in general and Indian biotech in particular as: "The Indian market is small and is not going to build a huge pharma or biotech internal market. Indian biopharma should be looking at the global market as India is uniquely situated between the developed and developing world. Today India has evolved as a raw material supplier for products but this is under competitive threat from both internal quarters and other countries like China. This is a race to the bottom. India can move up the value chain by competing on the manufacturing costs/processes, on the quality process and ultimately capture the proprietary product. India can partner early with companies, take the products through clinical trials and develop them. But there are issues of ban on phase I clinical trials of outside drugs and pharma companies face problems in getting animals for testing. Both of these issues should be solved politically. Also for clinical trials, hospitals records need to be automated and the general infrastructure needs to be improved. The biotech world is a resource-limited world, where to find new compounds, the companies will do anything to reduce costs. This has led to outsourcing of manufacturing, clinical trials, etc. to reduce costs while maintaining quality. India is an attractive destination for outsourcing because of the 'trust' that the western countries have in it. This should be stressed upon and preserved. The reason for this underlying trust could be due to India's preexisting integration with the western world, which will serve it well. Also India has a system of governance and laws and a fair legal system. In this way working through collaborations bring a product to the proprietary stage and take the product to the market. In this way, you own the product in part and benefit from it. In this way, India can move up from the bottom of the value chain, from being a supplier to the top of the chain." Also outsourcing is fast becoming the mantra of the biotech industry in today's global village. The lower operational costs of R&D in India (about one-tenth of that of developed countries) coupled with a large pool of qualified English speaking professionals and its traditional strength in the pharma business has helped contract research and manufacturing evolve into a huge market in India. Like wise India is also emerging a global hub in clinical trials. "The Indian Contract Research Organization (CRO)/services market is currently growing at 20 percent per annum and has excellent growth opportunities," said VV Raghavan managing director, Lotus labs, an independent Bangalore-based CRO. This segment coupled with the bioinformatics sector accounted for close to 85 percent market share in exports last year. While the inclination to biopharma is obvious, bioinformtics is another key arena. Till the previous year, bioinformatics accounted for about 4 percent of the total size of the biotech industry, but it is expected to catch up fast. With a strong IT infrastructure and knowledge base in India, this sector aims at capturing a significant market share both in India and abroad. Elaborating on the opportunities in this segment, Dr Akhilesh Pandey, chief scientific advisor, Institute of Bioinformatics, Bangalore said, "The next wave in bioinformatics is systems biology, which involves the integration of genomics, proteomics, and bioinformatics information to create a whole system view of a biological entity. Needless to say, the opportunities in the bioinformatics segment are vast and there is a shortage of trained personnel in this field today." India offers a huge market for agribiotech products as more than half of the country's population depends on agriculture. The surge in opportunity will be in improving agricultural productivity. "BioAgri will be a very strong sector in the years to come, in view of the Indian government's decision to open the market for biotech crops," remarked Dipankar Bandyopadhyay, HR Manager, Monsanto India. Monsanto, an integrated agri solutions provider, has introduced the country's first GM cropâ€”Bollguard (Bt cotton). Further, with European countries yet to finalize on the agribiotech policy, India opens up as an alternative destination. Said Prof. Sir David King, Chief Scientific Advisor, HM Government, and Head of the Office of Science and Technology, Department of Trade & Investment, the UK, "After his last visit to Bangalore, our Prime Minister Tony Blair had remarked that he was worried that the Indian biotech industry would overtake Britain's because India does not seem to be faced with the public that is skeptical about GM, whereas our public was. He was impressed and I am impressed too. But your( Indian) biotech industry is still very young and still in an early stage of growth. Our industry is looking for partnership with an eye for win-win." The growth of biotech industry both in research and manufacturing sectors is being supported with equipment, consumables and knowledge management tools by the BioSuppliers. There are about 25-40 key companies supplying biotech products in India. "The potential for BioSuppliers is increasing and the growth rate expected is around 13 to 15 percent. This is directly related with the biotech R&D and products for which equipments are required. The opportunities will increase slowly by 5 to 7 percent and by 2005 the rate will be substantially high," said MT Rananaware, DGM-Life Science, Alfa Laval (India) Ltd, Pune. Pro biotech policies Realizing the future potential of biotechnology, the Indian government is playing a proactive role and encouraging the growth of the biotech industry. Emphasizing this fact Dr Manju Sharma, former secretary of the Department of Biotechnology (DBT), Ministry of Science and Technology of India said, "India held great potential for using the tools of bioscience to boost its developmentâ€¦and the government wants to be a facilitator in this process." Established in 1986, DBT within the Ministry of Science and Technology focuses on research and training in the different areas of biotechnology, generation of quality human resources along with dealing in the complex regulatory affairs. DBT has played an important role in the biotech development and recently launched a five-year $20 million Indian Genome Initiative (IGI) to study the genetic variation of diverse Indian populations. In the area of genomics research, the government has set up Plant Genomics Centre (New Delhi) and Centre for Human Genetics (Bangalore). Also there is a proposal to spend $40 million annually over the next 10 years in genomic research. Due to the government support and its clear-cut policies, the Indian biotechnology industry is among the top five in the world in terms of stem cell research. While debate on ethics of using stem cells is going on in western countries, India is free of such controversies. Both the government and private industry have invested heavily in research institutes studying human disease and searching for treatments as well. The Health Ministry, with assistance from the US and Japan, has recently established a $40 million National Institute of Biologicals (NIB) in New Delhi to carry out research, manufacturing and clinical studies. Other government agencies involved in biotechnology R&D include: Indian Council of Medical Research (ICMR), Indian Council of Agriculture Research (ICAR), Council of Scientific and Industrial Research (CSIR) and Department of Science and Technology (DST). India has also signed the WTO agreement and will provide product patent protection by 2005, by changing its process patenting system. India has decided to accede to the Paris convention for the protection of intellectual property and the patent co-operation treaty. These moves will improve the industrial climate and encourage more research and development in India, by domestic and foreign companies. Optimism Furthering research in the area of life sciences (including some bit of biotechnology also) though existed in the research labs since a long time but was not considered a "happening" career. Today the scenario has taken the proverbial three sixty degrees turn. Biotechnology being a knowledge-intensive industry, intellectual capital is the prime driver. Last year, the R&D manpower in the Indian biotech sector grew by a phenomenal 74 percent of which women form a significant part. Most of the companies with which we interacted plan to increase their workforce in the near future. The Total Industry in 2002-03(Including the BioSuppliers ) SEGMENT Sales Revenues* Percentage Share Exports* Domestic Sales* Bio Pharma 1275 55 663 612 Bio Industrial 235 10 122 113 Bio Services 135 6 115 20 Bio Agri 110 5 6 105 BioInformatics 75 3 64 11 Bio Suppliers 475 21 60 415 Total Industry Size 2305 100 1029 1276 Biotechnology is the cocktail of many facultiesâ€”microbiology, biochemistry, genetics, immunology, chemistry, etc. Being an young and growing field, it offers excellent opportunities for qualified professionals having the relevant profile and training like microbiologists for manufacturing process; biochemists for down stream processing; biotech engineers for bulk manufacturing processes/process standardizing; plant molecular biologists, geneticists, plant breeders in the agri biotech sector; clinical investigators, clinical research associates, analytical chemists for clinical trials among others. Interestingly, most of the biotech companies have a strong sales and marketing teams also, which according to industry sources increased by about 51 percent last year. The salaries offered by the biotech companies are attractive, on par with those offered by other industries and have begun to reflect the growing demand for skilled people. The remuneration depends on experience, skills, quality and availability and generally varies from Rs 6,000 for freshers to Rs 50,000 or more per month for senior experienced people. This is just the beginning. BioSpectum's interaction with the industry shows that the Indian biotech industry is projected to have grown by about 26 percent by March end. According to Kiran Mazumdar-Shaw, chairman and managing director, Biocon, and president, the Association of Biotechnology Led Enterprises (ABLE), the Indian biotech has the potential to be a staggering Rs 45,000-crore industry by 2007-08. Definitely, if all things are put into place, there is no reason why this sector would not make India Shining. Rolly Dureha with inputs from Narayan Kulkarni in Mumbai and Faiz Askari in Delhi ]]> <![CDATA[Follow the Leader]]> https://biospectrumindia.com/news/95/1921/follow-the-leader.html https://biospectrumindia.com/news/95/1921/follow-the-leader.html Wed, 12 May 2004 16:14:00 +0530 Kiran Mazumdar-Shaw Chairman and Managing Director, Biocon India Ltd case study "All human actions have one or more of these seven causes: chance, nature, compulsion, habit, reason, passion, and desire." Aristotle There is no better way to illustrate the potential than to substantiate it with successful examples. Here are a few stories of people who by virtue of their contributions to biotechnology have carved a niche for not only themselves but the stakeholders too. The overwhelming response generated by the IPO of the first Indian biotech company, Biocon, is an example of teamwork, courage, and persistence. The credit for all this goes to Kiran Mazumdar-Shaw, who dared to become an entrepreneur and start a biotech company. Her company is a role model for both the biotech and business communities. But things did not happen over night. She graduated in BSc Zoology from Bangalore University in1973 and earned a Master Brewer degree from Ballarat College, Melbourne University in 1975. Kiran's venture into the biotech field was more an accident than careful planning. Back from Australia, armed freshly with a brewery degree, she found that women were not welcome in this field in India. But she had in her own word the "foolish courage". Her fascination for this new field (biotechnology) led her to start an office in a 3,000 sq.ft rented shed in Koramangala in December 1978. She started with an investment of Rs 1.5 lakh as a joint venture with Biocon, Ireland in which she held 70 percent equity. The first year's turnover was just Rs 10 lakh. Starting that way Biocon today is the leading biotech company in the country. This journey, from scratch to now, has taken Biocon more than 25 years. Pointing this out and advising on the virtues of patience Kiran said, "We have taken 25 years. Entrepreneurs should not be in a hurry to build their companies. You got to build a very strong foundation. And once you build that strong foundation, you can do anything that will take off in an exponential way. That has been the success story of Biocon. We have spent the first 20 years of our business life just building a very strong foundation of systems, skills, and very strong code of ethics and integrity, which can now help us to take very powerful strategic directions. We know now that whatever sector we get into, we have the best skills in the country." Dr V Ravi Kumar Managing Director, XCyton Diagnostics Ltd A doctor, a researcher and an entrepreneur Venkata Ravi Kumar Banda, is the person behind the country's first indigenous HIV diagnostic kit. Today, the kit is being used at premier medical institutes like the AIIMS. When AIDS hit the Indian shores in a big way during the 1990s, the country used to import HIV diagnostic kits. Recognizing this as a major gap in the Indian health care system, Dr Ravi Kumar ventured into the manufacturing of HIV diagnostic kits by starting XCyton Diagnostics in December 1993 with an initial capital of just Rs 7 lakh. "When I started, opportunities for funding were very less. All financial investors were scared of biotech companies and were not willing to put money," reminisced Dr Ravi Kumar. A medical doctor by profession, Dr Ravi Kumar completed his MBBS from JIPMER Pondicherry and practiced medicine for a short time. Later he joined the Indian Institute of Science, Bangalore to pursue post doctorate research. A brilliant researcher, he received Prof. Giri Memorial Gold Award for the best thesis and got an offer to work at the Astra Research Centre, India (ARCI). During his 8-year stint at ARCI, he developed a diagnostic kit for the detection of tapeworm and another for tuberculosis disease. This experience and exposure helped him to start on his own. With a strong foothold in Elisa kits Dr Ravi Kumar is moving towards the development of rapid tests and polymerase chain reaction kits. Presently the company is developing DNA-based PCR kits for bacterial meningitis in children, rapid kits for neurocysticercosis and an Elisa kit for detecting pulmonary tuberculosis. Giving a word of advice to young entrepreneurs he said, "Actually biotech has long incubation before it yields results. One cannot be impatient. Biotech products die many times during developmental stages. Promoters should have the conviction to persevere with the idea and resurrect the product using R&D as the major weapon." Dr V Prakash Director, CFTRI Dr V Prakash has been at the helm of affairs at Central Food Technological Research Institute (CFTRI) since the past 10 years and under his leadership the institute has filed over 623 patents. He is the key driving force behind the institute supporting rural livelihood on one hand and entrepreneurship development on the other. Dr Prakash had his early education at the University of Mysore and got his PhD degree in 1976. Further, he continued his research studies on a postdoctoral fellowship (1976-80) at the Texas Medical Centre, Houston and Brandies University, Boston. He returned to India in 1981 as a CSIR pool officer at CFTRI and rose to the position of CFTRI director in 1994. Mapping his career path, Dr Prakash said, "I started as a research fellow in 1970s, pool officer in 1981 and became director of the same institution in 1994. So one gets into a unique ambience of working with teachers, colleagues and studentsâ€”a rare opportunity indeed." Looking back, he recounted, "As a graduate student working on proteins, one of the thrills for us was to get a single band based on SDS page or a single sharp symmetrical peak in analytical centrifuge as one isolates a pure protein. My first paper in JBC as a PhD student was a thriller to me. But the area of life sciences, especially biotechnology is highly dynamic and ever changing. This area has the potential to give so much to the society today like health and food." Dr Prakash has more than 140 publications in national and international journals; has presented over 340 papers in conferences; and is the author of six books. He has 33 patents to his credit including some in the US and Europe. He is a member of many national and international committees including the WHO, UNDP and UNU and is on the editorial board of several scientific journals. He is a recipient of numerous awards including the Sarma Memorial award, Kashalkar Memorial award, and SS Bhatnagar award among others. An excellent scientist, a great visionary, he has been instrumental in steering the institute towards new standards of excellence by globalization of CFTRI technology. In recognition of his contribution to the food sciences he has recently been honored with the prestigious Padma Shree award. Dr Krishna M Ella Chairman and Managing Director, Bharat Biotech He started Bharat Biotech in 1996 with a mission to produce Hepatitis B vaccine at an affordable price for the common man. It successfully launched and started the commercial production of Revac B (World's first cesium chloride free Hepatitis B vaccine) in 1998. In 2003, the company achieved many milestones under Dr Ella's Leadership. It launched typhoid vaccine, Typebar, started contract manufacturing of Haemophilus Influenzae B (HIB) conjugate vaccine (HibTITER) for Wyeth Lederle and launched Indikinase, a recombinant streptokinase in the market. He is a classic example of scientist turned entrepreneur. Dr Ella was born in Tiruthani, near Chennai. He acquired his doctorate from the University of Wisconsin-Madison in molecular biology in 1992 and spent more than a decade conducting independent research and teaching in renowned universities in the US. Before embarking Bharat Biotech in 1996, he served as a professor (research) with Medical University of South Carolina (1993-96). He started his career as a research fellow with Indian Council of Agricultural Research, then joined Sandoz (I) Ltd as technical representative, moved to Bayer as technical officer, went to University of Wisconsin as research assistant among other things, before joining the South Carolina Medical University. For Bharat Biotech, in spite of being a successful biopharma company today, the start was challenging and tough. Elaborating on this Dr Ella said, "When we (Dr Ella and his wife Suchitra) returned to India we brought together like-minded professionals from the US. Sold personal assets in the US to make our dream come true. There were so many challenges that we had to face. For the first time, I proposed to produce the Hepatitis B vaccine for one dollar in 1994. None of the financial institutions in India were prepared to believe this." "The concept of bioentre-preneurship is still new in India. There is no easy path and we have to create one for ourselves. This is the industry's biggest challenge. Scientists in our country follow the road lined with obvious well-defined rules and symbols. While the need for academic excellence is understandable, the world out there is waiting for safe, affordable, healthcare solutions that can affect millions of lives. It is biotechnology that can come up with answers," he added. ]]> <![CDATA[BioSuppliers a hotspot for biomarketing skills]]> https://biospectrumindia.com/news/95/5982/biosuppliers-a-hotspot-for-biomarketing-skills.html https://biospectrumindia.com/news/95/5982/biosuppliers-a-hotspot-for-biomarketing-skills.html Wed, 12 May 2004 16:11:00 +0530 Several companies Agilent, Alfa Laval, Amersham Biosciences, BioRad, Cambrex Chemicals, Kendro, Millipore, Sartorius, Thermo Electron, Waters India and others have set up their subsidiaries in India and are supplying equipment on a large scale to the Indian biotech industry. Besides, there are Indian companies like Ace Instruments, Andel Equipments, Bangalore Genei, Biotech India, Genetix Biotech Asia, Life Technologies, Pharmalab, Praj Industries, Span Diagnostics and Toshniwal Instruments, which are manufacturing/supplying key equipments, consumables, etc., to the biotech sector. Employer Expectations Qualifications Required Research and Development Postgraduate, doctorate, post doctorate degree with specialization in plant molecular biology, biotechnology, tissue culture, plant breeding, seed technology, genetics, genomics, proteomics. Marketing MBA, MSc Agri, graduate/postgraduate degree with relevant experience in sales and marketing Selection Procedure Inviting resumes Screening Short-listing and then interviews Campus recruitment done Selection Edge Thorough domain knowledge Analytical and practical skills to plan experiments and execute them Hands on relevant experience Innovative ideas Good communication skills Training Specialized in-house training programs for employees Training programs/workshops conducted for students What are companies looking for? There is no one set pattern of job profile. "BioSuppliers could be both trading companies and manufacturers. Further biosuppliers could be classified on the nature of equipments/instruments or reagents, enzymes etc.. So it is difficult to group all the biosuppliers together. The segment is more niche unlike biopharma/bioagri," elaborated Dr P Babu, CEO, Bangalore Genei. The opportunities vary from company to company. If the company is primarily into manufacturing, like Alfa Laval, which is one of the leading manufacturers of engineering equipment and supplier of complete plants, then the main job functions will be pre engineering of the processes and products, preparing specifications and drawings, procurement and execution of projects with documentation. Accordingly, the company will look out for chemical/biotech engineers. Similarly, if the core competency of the organization is making reagents, diagnostic kits, enzymes, etc., then it will require candidates possessing post graduation or doctorate degree in biochemistry, biotechnology, microbiology or related life science fields. And if the company is a distributor of biotech products then it will require candidates having sound technical knowledge about the products along with strong sales and marketing background. Take another case. Cambrex Chemicals, a 100 percent subsidiary of the US based Cambrex Corp., assists the biotech industry in maintaining its product quality and also supplies ingredients used by the research institutions to develop new products. "The job categories are business managers, technical service managers, etc. We require graduates with a basic biological background and any additional qualifications would add value. The candidates should possess integrity, team-playing capability and the ability to work independently," said Vivek Varma, business managerâ€“biotherapeutics, Cambrex Chemicals. "At Genetix the job categories are business development executives, product specialist and customer care representatives," said Arun Prakash, managing director, Genetix. The company offers marketing and technical support to biotech and life sciences companies. "The qualifications required are MSc (for business development executives), PhD for product specialist (males/ females), graduates with computer skills for customer care representatives (females)," he added. In Amersham Biosciences, a leading global provider of biotech systems, products and services used in gene and protein research, drug discovery, development and biopharmaceutical manufacturing, the different levels of jobs throughout the organization range from product specialists, area manager, product manager, sales manager, application specialists, service engineers and service managers. "We have defined key responsibilities and accountability for each position/functions. For example, a sales person or product specialist would assist in product management, key account management and be responsible for conducting seminars and demonstrations to customer. Good communication skills, teamwork, self-motivation, perseverance, technical skills and a positive attitude are a few things we look for in a candidate. Candidates with exposure to the western scientific arena are also welcomed," said senior managers from Amersham. "In general, we look for candidates with a MSc or PhD degree in bio-related fields like molecular biology, biochemistry, and chemical engineering. A couple of years of either sales experience with a similar company or a couple of years of research experience in a lab or industry is a requirement. Specialization is a particular area is a definite plus. Being a technology-intensive company, a couple of years of either research or sales experience is a must," they added. Wipro Health Science is one of the top service providers, offering both IT solutions and supplying equipment to the biotech industry. According to Wipro officials, "At present the job categories are consultants, solution architects and software engineers and also biochemists in the future. The job functions are conceptualizing, designing and delivering solutions to research laboratories in industry and academia. Wipro is also setting up a reagent kitting setup to deliver reagents for its hardware solutions at a better price". Selection Procedure trend In the fiscal year 2002-03, the BioSuppliers market was worth Rs 475 crore There are about 25-40 key companies supplying biotech products to India. The sector is seeing a lot of activity and is abounding with opportunities for people from diverse backgrounds. The potential for BioSuppliers is increasing and the growth rate expected is around 13 to 15 percent. This is directly related with the biotech R&D and products for which equipments are required. The total segment is expected to grow between 20-25 percent. "The procedure for selection is recruitment either through manpower consultants (for more senior roles) or walk-in interviews (for junior roles). The qualifications required is laboratory background with masters or greater for consultants and BE+ for software delivery. We look for technical skills, customer focus and ability to envision solutions. Additionally, there are internal Wipro criteria for each hired person. Better communication skills and an ability to listen and comprehend what is being said clearly can give a definite selection edge, " they added. "Although internally there is a full-fledged training process and training courses on both technical as well as soft skills but it helps if the candidate has prior laboratory expertise and experience." Wipro is not currently recruiting but sees considerable scope in the next year. The growth potential for employees is excellent. Plenty of opportunity is available for growth within India and internationally too. "We are around 700 employees, for bio process department we are 13 and expected to grow to 20 by year end 2004. Depending on our growth of business, we may plan to recruit next year," said MT Rananaware. "The opportunity in the BioSuppliers segment is growing and in a manufacturing company like ours, there is a huge growth potential," commented Dr Babu of Bangalore Genei. "The person can become the head of his/her respective department along with improvement in job competence and personality development through good working environment and training programs," said Arun Prakash of Genetix. Rolly Dureha ]]> <![CDATA[BioServices attracts best practices]]> https://biospectrumindia.com/news/95/2268/bioservices-attracts-best-practices.html https://biospectrumindia.com/news/95/2268/bioservices-attracts-best-practices.html Wed, 12 May 2004 16:09:00 +0530 Increasing pressures on R&D cost containment across the global pharmaceutical industry, has led to a paradigm shift in the approach of major pharmaceutical companies. Outsourcing has become the mantra of the industry and contract research has evolved into a huge market. Employer Expectations Qualifications Required Contract research and manufacturing Entry Level: MSc in organic chemistry Molecular biology Microbiology Biotechnology Pathology Biochemistry or a related life science branch. Senior leading position: Doctorate or post doctorate with experience in drug discovery and related fields Clinical trials Postgraduates in medicine pharmacology and pharmaceutical analysis Selection Edge: Freshers Good subject knowledge Aware of the recent trends Willing to learn about other fields besides their core area Prior training on GCP, GMP, etc Experience not a must Campus Recruitment: From premier institutes like NCL, IISc, IITs, etc At present, the CRO segment in India mainly consists of contract research, contract manufacturing and clinical trials. The Indian market has companies doing clinical research and trials for the molecules developed in-house (captive CRO) like Eli Lilly. And there are organizations doing contract research and trials for other companies (independent CRO) like Quintiles Spectral, SIRO Clinpharm, Syngene, etc. Aurigene, Shantha Biotechnics and Chembiotech are some of the other important companies. Syngene International, a Biocon group company, set in 1994 was India's first integrated CRO in the area of drug discovery. It is presently serving over a dozen pharmaceutical R&D units in Europe and the US. Eli Lilly, Bharat Biotech and Shreya Biotech are some of the important contract manufacturing companies. "Contract research is very innovative, capital intensive and involves lots of R&D. Further the field is not process but product driven and cannot be operated on a large scale," said a senior official at Aurigene Discovery Technologies Ltd, a Boston based drug discovery organization, with research facilities in Bangalore. Besides contract research and manufacturing, India is also emerging as a global hub for clinical trials. "India is being projected to grow in this field on account of adequate patient population having a wide spectrum of diseases, qualified medical professionals, good communication network and IT capabilities," said VV Raghavan, managing director, Lotus labs, an independent Bangalore based contract research organization. "Clinical trial is a very data and quality intensive work and may involve high percentage of travel. The scope of any error is very limited and involves high degree of ethics both personal and professional," commented Rajiv Gulati, managing director and chairman, Eli Lilly and Company (India) Pvt Ltd. Quintiles, Specialty Ranbaxy, Siro Clinpharm, Eli Lilly, Clingene International (a subsidiary of the Biocon India group), Lotus labs, Clintec International, Pfizer, Novo Nordisk, Lambda Therapeutic Labs, Novartis, etc., are some of the companies conducting clinical trials in India. The Contract Research Organization (CRO) market has great potential and offers tremendous career opportunities. "The Indian CRO market is currently growing at 20 percent per annum and has excellent growth opportunities," said VV Raghavan of Lotus labs. "Market trends indicate that the CRO market is going to experience rapid growth in the coming years and will become an indispensable part of the drug development process. The CRO industry is a major employer of medical and scientific staff and hence the demand for qualified personnel is on the increase. The potential is huge and the opportunities exist at every level," observed Nirupa Bareja of Biocon. "The potential is for real, the opportunity could be as big as 150 crore in year 2007-8," said Rajiv Gulati of Eli Lilly. "As on date, clinical research is still a sunrise industry in India and contributes just 0.7 percent to the global clinical research industry but this scenario is soon expected to change. India is tipped to be one of the major hot spots for clinical research in the coming decade. Analysts estimate that by the year 2010 India would contribute 20 percent to the global clinical research industry revenues," commented Shamiq Hussain, general manager, Clintec (India) International, a Europe based CRO. This optimism is bound to translate into a huge job market for the students. In most of the companies, the standard procedure followed is inviting resumes through advertisements, screening and short-listing of the candidates, and then interviews. Nirupa Bareja of Biocon says, "from a qualifications perspective we look for post doctorates, doctorates, medical doctors, post graduates in the fields of organic chemistry, molecular biology, microbiology, biotechnology, pathology, biochemistry, pharmacology, etc depending on the job profile. At Biocon India in addition to the technical competency trend The global market for such services in 2002 was estimated to be $1.2 billion and may grow to $3 billion in 2008. India is being considered as a destination for contract research and manufacturing and other services that are needed for the growth of the biopharma segment. The contract research and clinical business in India during 2002-03 was Rs 135 crore. Quintiles Spectral, SiroClinpharm, and Syngene are the three key independent CRO players here. These three account for 71 percent of the market. Top 10 pharma companies may increase their primary screening of compounds from $10-15 million now to $200 million per year in another two years. we look for a scientific analytical temperament (as a mandatory quality) in an individual. They must also be result oriented, team players with good interpersonal skills, innovative, performance driven, leadership oriented, creative out of the box thinkers and passionate about the job". This sentiment is echoed by most of the company heads. "We look for candidates having flexible thinking, a confident attitude and an aptitude for learning about other fields besides their core area," said Dr Swaminathan of Aurigene. "We look for aspiring candidates who have a desire to learn and grow in this field" commented VV Raghavan of Lotus labs. "In the contract industry the people should be highly skilled and versatile to take up different projects and execute them at low cost in order to be competitive and effective," was the opinion of Raman Akella, head administration, Shantha Biotechnics, Hyderabad. For recruitment many companies go to premier institutes like NCL, IITs, IISc, etc., in addition to recruitment through referrals, headhunters, advertisements, CVs received electronically and by mail etc. At the entry level prior experience is not always sought, though is sometimes preferred. The manpower requirements for each project could vary and range from two people to a hundred people per project. "The manpower need is typically dependent on the extent and the nature of outsourcing which is done to the CRO and is also dependent on the phase of the clinical trial work undertaken," observed Rajiv Gulati of Eli Lilly. In any CRO the job categories depend on the nature of the contract service undertaken. Scientists in the field of synthetic organic chemistry, molecular biology and bioinformatics are required at Biocon. Aurigene looks for screening pharmacologists, chemical researchers and experts in the field of genomics, computational biology and bioinformatics when the project is in the initial stages of drug discovery. A few job categories at Shantha Biotechnics are fermentation, purification/process analysts (technical), quality assurance, registration/documentation personnel (regulatory), plant and process, quality assurance, operations personnel (management) and medical advisors. In a company conducting clinical trials the job categories could be multifaceted like coordinator, monitor, clinical investigator, research associate, clinical research physician, analytical chemists, trial materials manager, project manager, medical writers, data managers, documentation personnel, lab technicians, statisticians, etc. Rolly Dureha ]]> <![CDATA[BioInformatics elicits IT savviness]]> https://biospectrumindia.com/news/95/2338/bioinformatics-elicits-it-savviness.html https://biospectrumindia.com/news/95/2338/bioinformatics-elicits-it-savviness.html Wed, 12 May 2004 14:12:00 +0530 Many bioinformatics companies are coming up to cater to these needs of pharma and biotech industry, which provides growth opportunities in terms of knowledge base and career advancement. "There is a lot of data to be managed and mined. However, biotech companies over the last two years have been busy surviving and had not looked at solution providers for informatics solutions in a big way. Pharma companies, on the other hand, look for ready products to be bought and are generally averse to outsource custom projects. Availability of free software or software bundled with analytical equipment is another challenge facing the pure play bioinformatics companies," pointed Ajay Simha, director, SysArris Software Pvt Ltd, a company offering IT software solutions and services to the pharma and biotech segment since the past eight years. Employer Expectations Ideally a student should have: â€¢ Sound knowledge of molecular biology â€¢ Knowledge of UNIX/Linux the operating system used for many computational biology programs â€¢ A good grasp of the concept of relational databases, which are the heart of bioinformatics â€¢ Programming languages such as Perl or Python, which are popular in the field of Bioinformatics. In the future, knowledge of object-oriented databases may be increasingly important â€¢ Expert knowledge of sequence-analysis programs like BLAST is critical. â€¢ Web skills, of course, are necessary, including the ability to write Hypertext Markup Language (HTML) Vibhav Garg, functional consultant, Mascon Life Sciences, a company that develops bioinformatics software for pharma companies and research labs, feels that the current buzz about bioinformatics is partially justified. "There is an urgent need to understand the available data. But the hype created by unauthorized so-called training centers is absolutely unwarranted and many times creates confusion in the minds of new entrants," Garg informed. Bioinformatics companies generally have well-defined teams with a clear business focus. For example, in Mascon, there are three groupsâ€”a functional team, which is the driving force, consists of domain experts. The development team is the supporting arm and comprises the software professionals. Then there is a business development team. Likewise, SysArris has domain experts who are thorough in genomics, cheminformatics and other areas. These experts understand the requirements of customers, analyze it and suggest the solution. The software team then converts the requirements to a software solution. Till last year, bioinformatics accounted for about 4 percent of the total size of the biotech industry, but it is expected to catch up fast. The total sales revenue (2002-03) generated by this segment was about Rs 75 crore and a major chunk of it (64 percent) was through projects for overseas companies. Today most of the companies in this segment are small to mid size, with employees ranging from 25 to 200 plus and the average man to women ratio is 2:1. The salary range depends on the experience and capabilities of the person and performers are recognized and well rewarded. "While the starting salaries could be anywhere from Rs 10,000 to Rs 20,000 per month depending on the experience of the candidate, it can go up very high as there is a review every six months," said Anuradha Acharya, CEO, Ocimum Biosolutions. Others too feel the same. The salaries offered can start from Rs 1.8-2 lakh per annum and can reach as high as Rs 12-15 lakh per annum based on the experience and type of skills. This nascent field provides immense growth opportunities in terms of knowledge base, market exposure and career advancement. "We have identified several growth tracks for our employees. These could be either in pure software development, bioinformatics, management or sales and marketing. A person could start as a trainee, bioinformatician or software developer and could end up becoming part of the top management," added Anuradha. Selection process For entry and junior level candidates, companies conduct written tests and interviews, whereas at senior levels intake is generally through referrals and a round of discussions. "We generally look for people with at least one year relevant experience; if no suitable candidates are found, we take the most suitable candidate and train on-the-job," said Ajay Simha. Some of the companies do campus recruitments. Often, companies prefer to go to the IITs and RECs. Besides the basic qualification (a masters or higher degree in a branch of life science or computer science), prior experience or training in the industry or research organization is an added advantage concur most company heads. But the experience required would depend on the openings from time to time. As such, bioinformatics being a new field, it is very difficult to get people who have cross-functional expertise. Hence, the companies generally provide training before putting the candidate to work. Most of them have arrangements for short-duration high-end specialized training for their employees. trend Global bioinformatics segment expected to grow to $6 billion by 2005. In the next 10 years most new drug designs will be genomics-related There is a global shortage of one million professionals in this field Though the opportunity exists, bioinformatics is not and cannot be compared with the IT sector say industry observers. According to YK Maheshwari, Sr VP, health care and life sciences, Kshema Technologies "hands-on training or experience is not a necessary prerequisite, but those with such experience are obviously preferred. Selection is easier for engineers or professionals, who have developed software, who understand the development SDLC (Life cycle processes) and know the requirement gathering process or candidates with knowledge on data warehousing, business intelligence, pharma workflow, lab management systems, FDA approval process, drug discovery life cycle". A prior working knowledge of various analytical instruments like the HPLC, MS, DNA microarrays, etc help in understanding not only the functionality of the systems but also the complex data output for further analysis to be carried out and experience of using software applications like LIMS, drug discovery tools, etc. help in understanding where the existing market available tools fail to achieve a scientist's need. So is there a future? Maheshwari summed up: "There are multiple opportunities, in what goes under the wide banner of bioinformatics. Technical developments such as molecular genetics, proteomics and metabolomics provide the analytical base to support the advances in life sciences, but there is a demand for novel automated tools to reduce the time involved in the discovery life cycle. There is a shortage of individuals, though critical for the future, with the necessary multidisciplinary expertise for the development of genomic/analytics applications that demands a high level of knowledge/interpretation skill beyond that previously employed in the information technology sector." But at the same time the buzz about bioinformatics is not entirely justified since it undermines the requirement of core strengths such as fundamental biology, genetics, molecular biology, statistics, computer science and mathematics and places emphasis instead on a loose mix of all these fields. Rolly Dureha ]]> <![CDATA[BioAgri draws domain specialists]]> https://biospectrumindia.com/news/95/2410/bioagri-draws-domain-specialists.html https://biospectrumindia.com/news/95/2410/bioagri-draws-domain-specialists.html Wed, 12 May 2004 14:09:00 +0530 The thrust on the bioagri segment has led to the establishment of new companies. Many traditional seed companies have also branched out into agricultural biotechnology. This industry has requirements in the areas of research, technical support and marketing and most of the companies are both into product development and marketing. Employer Expectations Qualifications Required Research and Development Postgraduate, doctorate, post doctorate degree with specialization in plant molecular biology, biotechnology, tissue culture, plant breeding, seed technology, genetics, genomics, proteomics. Marketing MBA, MSc Agri, graduate/postgraduate degree with relevant experience in sales and marketing Selection Procedure Inviting resumes Screening Short-listing and then interviews Campus recruitment done Selection Edge Thorough domain knowledge Analytical and practical skills to plan experiments and execute them Hands on relevant experience Innovative ideas Good communication skills Training Specialized in-house training programs for employees Training programs/workshops conducted for students "As agriculture is a dominant sector in India, we see a huge opportunity. The surge in opportunity will be in improving agricultural productivity," said Dr Villoo Morawala-Patell, founder and CEO, Avestha Gengraine Technologies, a fully integrated biotechnology and bio-informatics company. "BioAgri will be a very strong sector in the years to come, in view of the Indian government's decision to open the market for biotech crops," said Dipankar Bandyopadhyay, HR Manager, Monsanto India. Monsanto, an integrated agri solutions provider, has introduced the country's first GM cropâ€”Bollguard (Bt cotton). Dr Gautham Nadig, director, Metahelix Life Sciences, commented, "Indian market is big and value lies in making products suited to Indian agronomy and markets." Who are needed? Depending on the domain specialization of the company, the job categories vary and accordingly the qualifications required also differ. Morawala-Patell said, "The different job categories at Avesthagen are technical, scientific, business development, administration, finance, legal, PR, clinical, product development and software programmers." She added, "We have a separate bioagri segment with state of the art laboratory and high throughput technology to cater to various R&D services. We recruit people with PhD and MSc for the science aspect of business and MBA's for business development and other management related positions, LLB's and also people specializing in patent law." Camson Bio Technologies, a Bangalore based agribiotech company, is into research, development and marketing of biopesticides and seeds. Dhirendra Kumar, CEO, Camson said, "The minimum qualification that we look for is BSc agriculture coupled with a dynamic and enthusiastic approach. A basic knowledge of crops, diseases, etc is essential for this field. For marketing MBA's are preferred." Nunhems seeds, a subsidiary of Nunza BVâ€”a Netherlands based vegetable seed company, is involved in research, production and marketing of seeds throughout India. "We look for MSc and PhD degree holders in molecular biology, biotechnology, tissue culture and their main responsibility is molecular analysis of the material of both lab and field studies and maintenance of tissue culture plants," explained Dr Arvind Kapur, MD, Nunhems seeds. Companies like Indo-American Hybrid Seeds (IAHS) and Prabhat Agri Biotech have independent biotech divisions, which employs scientists and technical assistants. Companies look out for candidates with strong subject knowledge, analytical and practical skills, focused approach and good communication ability. Monsanto broadly focuses on three areasâ€“agricultural chemicals like herbicides, hybrid seeds and biotech/GM crops. "For the R&D division doctorates and post doctorates with domain specialization and relevant experience are required. They should have a very high level of technical competence and analytical bent of mind. In the sales division, there is intake of candidates with diverse qualifications like MBA, MSc Agri, BCom, PhD, etc. Basically they should have the core ability to understand and explain to the farmers about the merits of the products. Experienced candidates (2-3 years of relevant experience even from a non-agri FMCG background) do have an advantage, but we also take in freshers. Our main focus is not on experience but on the potential of the candidates to deliver and do the job. We focus on a diverse profile," said Dipankar Bandyopadhyay, Monsanto India. Dr PS Rao, VP-Biotech, IAHS said, "We do employ postgraduate/PhD degree holders in biotechnology. If the candidate is strong in basics of plant sciences and is able to communicate well, then he has a better chance. This of course includes basic qualification/experience that is desirable. We look for individuals with commitment, who can use biotech tools to enhance crop productivity." "Though it is not essential to have experience but a strong academic record and a clear understanding of the basic science is required," he added. But experience is an important selection criterion in some companies as Dr Sateesh Kumar of Prabhat Agri opines, "Candidates are selected after personal interviews and experience gives a definite selection edge as bioagri requires more technical and practical lab-oriented skills apart from intelligence". Selection Process trend In most of the companies the size of the core work team ranges from about 35 to 100. The agribiotech market in 2002-03 was Rs 110 crore in 2002-03 (GM crops, biopesticides and biofertilizers) The GM seeds business was Rs 16.8 crore from Mayhco. Inviting resumes, screening, short-listing and then interviews is the standard procedure of selection. "At Monsanto recruitment takes place through consultants or through the career section on Monsanto India's website where interested candidates can post their resumes. These resumes are screened and shortlisted candidates have to appear for two rounds of interviews. But in case there is recruitment on a large scale then, in addition, there is a general discussion round also. Lastly there is a reference check," elaborated Dipankar, Monsanto India. Dr Rao, IAHS said, "there is an HRD division and the candidates are taken in through a selection committee of experts in the respective field." Campus recruitment is the norm in some companies. As Morawala-Patell said, "We are always on the look out for quality people depending on the projects executed and domain knowledge of an individual. Since biotechnology as a sector has close links with academia, campus recruitment are one of the avenues to find aspirants willing to work in the biotech industry." "Campus recruitment is done and some of the institutes where we go are Gandhi Krushi Vighnana Kendra (GKVK), Bangalore, MANAGE, Hyderbad and GB Pant Agricultural University, Uttaranchal," informed Dhirendra Kumar of Camson. Constant upgradation of employee skills and the awareness of the latest developments is facilitated by the companies through a range of training programs. "Training is provided as and when required. For example in areas such as commercial micropropagation the candidates are put on training for a period of 6-12 months within the organization," said Dr Rao, IAHS. "There are regular product training programs in the segments of agri chemicals, hybrid seeds and GM crops. We have Monsanto Advanced Sales Training (MAST) for the sales and marketing division, " said Dipankar Bandyopadhyay, Monsanto. In the near future agribiotech will no longer be a discrete sector but will become an extension of the existing agricultural system and the industry will see a slow shift from chemical to gene- based solutions in agriculture. Rolly Dureha ]]> <![CDATA[Medi Spec hopes to double its revenues]]> https://biospectrumindia.com/news/95/2024/medi-spec-hopes-to-double-its-revenues.html https://biospectrumindia.com/news/95/2024/medi-spec-hopes-to-double-its-revenues.html Tue, 11 May 2004 19:07:00 +0530 Medi Spec Instruments India Ltd (MIIL) involved in marketing and serving of analytical, medical and diagnostic products is looking at doubling its revenue during the financial year 2004-05 over last year's revenue of Rs 10 crore. To achieve this, the company is looking at recruiting more field staff. Vipul Chhatbar, director, MIIL, said, "At present our field strength is 21. And by the end of this year, we want to increase it to 30. We are launching a couple of new products in July." MIIL provides sales, marketing and technical support, and consultancy for companies who wish to and desire to penetrate the rapidly growing Indian market. This ISO 9001:2001 certified firm represents 16 overseas manufacturers in India for their diversified laboratory product range with its thrust on biotechnology and molecular biology. It caters to a large market segment and its customer base includes companies from the pharmaceutical, biotechnology, food, clinical, and medical laboratories to government research institutions and universities. Chhatbar added, "Ours is the only supplier company which has the ISO 9001-2001 certification. To the best of my knowledge, even the MNC suppliers don't have this certification." Replying to a question on competition in the suppliers' segment, Chhatbar noted that there are many players in this field as the margins are as high as 15-20 percent. Some times, it would be even more. Five years ago, for gel documentation systems, there were only five competitors, but now there are over 20 companies competing for the same product. Life sciences contributes 15 percent to SAS India's total revenue SAS India, a provider of new generation business intelligence software and services, is expected to grow at about 40 percent in 2004 as against 30 percent last year. In 2002-03, the company's estimated revenue stood at Rs 40 crore. About 15 percent of the revenue (Rs 6 crore) is from the life sciences sector. Most of the Indian clinical research organizations such as SIRO Clinpharm, Novartis, Pfizer, Quintiles, and GSK are its clients. Besides life sciences, it does provide services to IT&ITES, telecom, and financial companies. Vivek Gokarn, managing director and CEO, SAS India, informed, "The Indian pharmaceutical industry is growing at a fast pace and companies are investing in their R&D activities to face the international challenges. The CRO segment is mushrooming up in India too. These are very active in conducting Phase I-IV clinical trials. SAS provides a complete solution on data warehousing, analytics, data management, data analysis, clinical research and traditional BI applications to create intelligence from massive amounts of data." It recently introduced SAS 9â€”a platform with enhanced analytics and refined user interface that provides fresh insights for solving business problems and driving competitive advantage. Don Cooper Williams, director, marketing and alliance, SAS Asia Pacific noted that India has taken a lead in life sciences sector and is far ahead over China. The revenue contribution of life sciences in SAS Asia Pacific is about 9 percent as against India's contribution of 15 percent while that of the SAS worldwide is just 7 percent. Genetix's revenues up Genetix Biotech Asia Pvt Ltd registered 40 percent growth in its revenues during 2003-04 to record Rs 25 crore in sales. Satisfied with the progress, Arun Prakash, managing director, Genetix Biotech, informed that the company is now eyeing to notch Rs 35 crore in revenues by the end of current fiscal year. Prakash added, "Now our thrust will be much more than last year. More companies are going to come with us. Very soon a few new companies that are leaders in their segment would be coming to India through Genetix." Hysel to distribute HyClone's products New Delhi-based Hysel India Pvt Ltd will distribute HyClone products in the Indian market. HyClone is a global supplier of cell culture and bioprocessing systems for application in research and production. This US-based company is widely known as the premier supplier of quality FBS and other sera for cell culture. HyClone also manufactures classical media and new serum-free and protein-free media formulated for commonly used cell lines. In addition to sera and media, the company also provides BioProcess Containers (BPCs)â€”sterile, disposable bags of medical grade film ideal for transport, dispensing and storage of sterile liquids. "HyClone media, buffers, and WFI are available conveniently packaged in BPCs. And these BPCs may also be custom configured for particular applications," informed VS Narayanan, director Hysel India Pvt Ltd. He further added, "HyClone has also pioneered the use of high retentive filtration techniques including triple 100 nm and 40 nm pore size rated filters to ensure sterility." Another director of Hysel, Vijay Chugh informed, "So far the response from the industry is good. The company's product range is widely used by eminent research institutes, pharmaceutical industries etc. Since, HyClone is a leader in its market segment, almost all the concerned people of the scientific community are well aware about quality of its product." Bio-Rad receives USDA permit for BSE test The California-based Bio-Rad Laboratories, a manufacturer and distributor of life science research products and clinical diagnostics, announced that its rapid TeSeE test used for the detection of Bovine Spongiform Encephalopathy (BSE), also known as mad cow disease, has been licensed by the United States Department of Agriculture (USDA) for use in the National Veterinary Service Laboratories (NVSL) in Ames, Iowa and all the NVSL network laboratories as part of the USDA's newly enhanced BSE testing program. It is estimated that this new program will test approximately 400,000 animals over the next 12-18 months. IDT ties up with Imperial Bio-Medic Chandigarh-based Imperial Bio-Medic (P) Ltd and Integrated DNA Technologies Inc. (IDT) joined hands for capturing the Indian custom DNA synthesis market. Neeraj Gupta, corporate vice president, Imperial, informed, "We have recently signed an MoU with IDT and are looking forward to strengthen our relations. They are worldwide leaders in custom DNA Synthesis segment. We firmly believe that together we will attain good heights in the Indian market as well. The product range that IDT is offering includes almost every aspect of high-end research. Since R&D is becoming a buzzword these days, we can predict good days ahead for us." IDT now routinely fulfills large-volume orders consisting of hundreds of thousands of oligonucleotides. Today, virtually every oligo synthesized is thoroughly tested by mass spectrometry and must pass strict quality control guidelines to be shipped to customers. In addition to improving the quality of custom synthesized DNA, IDT has increased the speed at which customers receive oligos with unique SameDay oligo synthesis and Rapid HPLC purification services. With the kind of spectrum, which has been offered by the principle company, Imperial Bio-Med is looking at the Indian market with a confident approach of capturing this niche egment of Indian research community. Regulators approve Pall's drug purification process Pall Corp. announced that, with collaborators from BioMarin Pharmaceutical Inc., it would present data that demonstrates significant new advances in the safety and economy of protein purification. BioMarin is the first company to receive licensure from the US Food and Drug Administration (FDA) and the European Medicines Evaluation Agency (EMEA) for a drug product using a Pall dual membrane-based process, setting a new standard for biological purification in the industry. Pall Mustang Q membrane technology is understood to significantly reduce the possibility of a failed batch due to DNA contamination, an extremely costly problem with potential human health implications. Agilent introduces upgraded proteomics software Agilent Technologies Inc. has introduced a major upgrade to its Spectrum Mill MS proteomics workbench. The Spectrum Mill workbench is a suite of software tools for confidently identifying proteins from mass spectrometry (MS) data, determining protein expression levels and correlating data from multiple samples or experiments. It includes advanced data extraction and searching capabilities that greatly speed protein identification and reduce the number of false positive matches. The software can process data from both Agilent and non-Agilent mass spectrometers. The new version of the Spectrum Mill MS proteomics workbench supports the Microsoft Windows Server 2003 and Windows 2000 Server operating systems. BBI becomes Sartorius BBI Systems Melsungen-based B Braun Biotech International GmbH (BBI), a manufacturer of fermenters and bioreactors and a subsidiary of the Sartorius Group, has a new name with effective from March 1, 2004 and will now be called Sartorius BBI Systems GmbH. This change of name also entails an alteration of the company's visual appearance. Sartorius BBI Systems will adopt all essential components of the Sartorius Group's corporate design. Amersham Biosciences advances gene expression Amersham Biosciences, the life sciences business of Amersham, announced the addition of the CodeLink human whole genome bioarray to its CodeLink range. The first CodeLink bioarray to offer comprehensive genome-wide expression profiling of an entire genome is the result of significant advancements made to the CodeLink platform. This new whole genome bioarray enables researchers to significantly discover more by consolidating genome-wide expression profiling into a single chip microarray experiment and increasing the assay sensitivity. ]]> <![CDATA[Faith in chloroplast transformation]]> https://biospectrumindia.com/news/95/7015/faith-in-chloroplast-transformation.html https://biospectrumindia.com/news/95/7015/faith-in-chloroplast-transformation.html Tue, 11 May 2004 18:58:00 +0530 Researchers at IARI back chloroplast transformation techniques. A defender of transgenic technology stated aggressively from a conference table: "There is no hue and cry about this technology (chloroplast transformation techniques) amongst the industry. Unaware people might be crying because they are not aware with the techniques involved in this technology." Why is his faith on this technology so strong? The cutting edge research work that is in progress at IARI's National Research Centre on Plant Biotechnology demonstrates a point or two. Dr Kailash C Bansal "So far we have used nuclear transgenic technology. But time has come to look beyond the traditional ways and enhance the outcome by making more changes to the prevalent technology. Chloroplast transformation is one of them. This innovative technology can be termed as an improved version of nuclear transgenic technology," informed Dr Kailash C Bansal, satisfied with results he got during the research work. Dr Bansal is principal scientist at National Research Centre on Plant Biotechnology, IARI, New Delhi and also heading the Plant Tissue Culture Lab there. Elaborating the advantages of this technology, he said, "There are several advantages like better environmental biosafety and better insect resistance." It was in 1992, when Dr Bansal came to know about this cutting edge research work at Rutgers University, USA under the leadership of Prof. Pal Maliga. Later on in 1996, he got the opportunity to work with Dr Maliga, for the same project. Dr Bansal brought this research work to IARI a few years back. "At this center, we are focusing on developing potato, tomato and mustard varieties. We have started research on maize too. Besides, we are also working on a few other horticulture crop varieties," informed Dr Bansal. It is not that this technology has not been tried out. "It is already perfected in tobacco and has been successfully marketed in the US," Dr Bansal added. Why are Dr Bansal and his team so excited? Through this technology, transgenic plant varieties can be developed without any antibiotic selection marker. Apart from this, by adopting this technique, spreading of transgenic gene to other neighboring crops can also be prevented. According to Dr Bansal there are reports that confirm development of resistance to herbicides by weeds or to Bt toxin by insects pests in case of Bt transgenic crops. In such a scenario, it becomes more challenging to tackle the problem of gene outflow to the weedy or wild relatives of cultivated crops of agricultural importance. "Based on the occurrence of agricultural crops and their related wild or weedy species in the same geographical regions, it is suggested that chloroplast transformation should be a method of choice for generating improved transgenics in crops such as rice, sorghum, cucurbits, vigna species, Cajanus species, solanaceous crops, and Brassica species. In addition, maize, wheat and cotton should also be included in the above list." His defense was that this technology is safe for environmental biosafety. "By safeguarding the neighboring crop, we do not have any danger of environmental biosafety. Actually, in this technique, the transgene remains locked up in chloroplast. There is no pollen in chloroplast. And there is no question of spreading the transgene through pollen. Hence there is no threat from pollen to spread the gene to neighboring crops." He cited some more advantages. "This technique is also helpful in producing protein rich variety at a unprecedented high level. Soluble protein ranging from 4 to 40 percent is found in the produce of results of this research." So from farmers to direct consumers, biotech to pharma industries all can avail the fruits of this technique. "For instance, if we use plants as bioreactors for pharmaceutical application, then this technique would be very useful as it has the ability to produce protein rich plant variety. But it would take another few years to make this technology ready for the industry," Dr Bansal said. He reminded, "It might take more than a year to actually come into the market, but spreading correct message about this is vital for the success and future of this technology." Faiz Askari ]]> <![CDATA[Nugen to distribute ultrasonic processors]]> https://biospectrumindia.com/news/95/2538/nugen-to-distribute-ultrasonic-processors.html https://biospectrumindia.com/news/95/2538/nugen-to-distribute-ultrasonic-processors.html Tue, 11 May 2004 18:55:00 +0530 Nugen Scientific, a Delhi-based company, has tied up with the US-based Sonics & Materials Inc. to supply ultrasonic processors for industrial applications. Introducing this product range in India, Rakesh Sharma, managing director, Nugen, said, "This product range has lot of market potential. Since the principal company is a market leader in foreign markets, this leadership can be maintained in the Indian market too." The model name of ultrasonic processor for industrial applications is VCF 1500. "This can be used by itself or with the optional high volume continuous flow cell. When used in conjunction with the flow cell, throughput rate is typically 100 liter/hourâ€”variables being viscosity and desired degree of processing. The flow cell is recommended for the treatment of low viscosity samples that do not require extended exposure to ultrasonics," further informed Sharma. Bio-Tek launches new Synergy HT multi-detection microplate reader Bio-Tek Instruments is launching new technology for its Synergy HT multi detection micro plate reader. Along with absorbance, fluorescence and time resolved fluorescence, this addition to the Synergy HT series enables low light output luminescence applications. Its applications include reporter gene analysis, flash ATP assays, and reactive oxygen species, luminescent immuno assays. The Synergy's unique dual optics system ensures optimal performance for each measurement modality. The highest sensitivity in florescence is achieved with an ultra stable tungsten/halogen light source coupled with deep blocking interference filters. A xenon flash lamp provides unsurpassed flexibility in absence especially in low UV and near IP applications with a detection range from 200 to 999 nm. The new low noise detection system operated in photon integration mode enables high sensitivity luminescence measurements. KC4 data reduction software with PowerReports comes with all Synergy HT models. The new interface allows the user to create any sequence of dispense, shake, incubate and read steps. Full 21 CFR part 11 compliance is also available. For details contact: miil@medispecindia.com On-line total organic carbon analyzer from Measure Test Corporation Anatel's Access 643 TOC Analysis System is designed specifically for the pharmaceutical industry to meet all the requirements for the USP and TOC and conductivity methods. It maximizes the convenience of on-line analysis by using a multi-point calibration procedure at pharmaceutical TOC levels that can be performed conveniently and directly at the installation site. The Access 643 includes a user-friendly menu driven system suitability test that automatically calculates the required response efficiency and indicates the water's pass/fail status. USP method is also easily performed with the Access 643 with the inclusion of a receptacle for inserting a NIST traceable resistor for the meter accuracy test. A fully integrated validation package is available for the Access 643 TOC analyzer. This comprehensive hardware and software validation package is a simple, easy to follow step-by-step plan for system validation. It identifies the required activities to ensure proper installation, operation, and performance of the Access 643 TOC analysis system, as well as compliance with industry standards and USP methods and . For further information contact: sheesh@vsnl.com Chromatography chambers for day-to-day R&D applications To meet the day-to-day R&D activities of pharmaceuticals and biotechnology industries, Pooja Lab Equipments has Chromatography chamber which features precision microprocessor based controls and efficient mechanical air convention for exceptional uniformity and control of temperature. The interiors are of corrosion resistant 304 SS and exterior is powder coated MS/SS. The inner cabinet ensures absolute insulation and energy conservation. Non-conductive inner doors allow access to compartments. This minimizes cold air loss in the unopened compartments. Full view glass door has full gasket and mechanical latch for tight, leak free closure with lock and key. The refrigeration system with hermetically sealed compressor uses the latest CFC-FREE Eco friendly sealed refrigeration technology. Microprocessor based controller is convenient and user friendly with high visibility LED digital readouts of temperature with fast sensing and reliable sensor of PT-100. For more details contact: poojalab@vsnl.com Thermo Electron introduces Finnpipette Novus Finnpipette Novus is the latest introduction by Thermo Electron in its Finnpipette range of micropipettes. Finnpipette Novus is the most advanced electronic pipette packed with advanced yet extremely user-friendly features. Like all Finnpipettes the new Finnpipette Novus has been designed so as to make it a highly ergonomic and reliable pipette. It has 10 pipetting options and 9 different aspiration and dispensing speeds for pipette, stepper, dilution, and sequential dilution/aspiration modes. Its light trigger action dispensing button, patented soft-touch tip ejector and light adjustable Finger rest rotating 60o adds to its ergonomic design making it a stress free pipetting device. The pipette comes with a facility to have personalized name, a long lasting Lithium-ion battery and has an easy in-lab calibration facility. Finnpipette Novus also has a counter to count the pipetting actions after recalibration. For more details contact: bimal.desai@thermo.com ]]> <![CDATA[Intas ready for its first biotech product launch]]> https://biospectrumindia.com/news/95/2856/intas-ready-for-its-first-biotech-product-launch.html https://biospectrumindia.com/news/95/2856/intas-ready-for-its-first-biotech-product-launch.html Tue, 11 May 2004 18:53:00 +0530 Intas Biotechnology, a division of Ahmedabad based Intas Pharmaceuticals, will launch its first biotech product, Neukine, a granulocyte colony-stimulating factor (G-CSF) in June. Further, within a span of 12 months, it expects to release two more biotech productsâ€”erythropoietin, used for cancer and kidney disorders, and interferon, used for therapeutic applications in cancer and infectious diseases. R Chandrasekaran, vice president, marketing, biotech and oncology, observed, "Intas would enter the less regulated international market in a span of 3-9 months after releasing the products in India. The present market potential for these biotech products is approximately $97 million. And Intas is looking at 20 percent of the market share in the first year of its product launch. In India, while the market potential for G-CSF is Rs 20 crore that of erythropoietin and interferon is over Rs 50 crore and Rs 35 crore, respectively." Intas has identified the market for its biotech products and looks to introduce them in the Latin American and Asia Pacific countries. It believes in taking the small-volume high-value business route. Intas Pharmaceuticals has so far invested close to Rs 40 crore in Indus Biotherapeutics Ltd, a wholly owned subsidiary of Intas Pharmaceuticals. It has already begun exporting proteins to other countries. Chandrasekaran informed, "Indus Biotherapeutics started as R&D center in 2000. It has a team of 25 scientists including seven PhDs and is working on recombinant products such as interleukins, growth factors and hormones. The multi-product bulk manufacturing facility is fully operational and the facility is being used for production, fermentation, cell culture and downstream processing of recombinant DNA products. The manufacturing facilities are approved by TGA â€“Australia, MCC-South Africa and MCA-UK." â€¦ launches Arsenox Intas has announced another developmentâ€”an affordable treatment for relapsed Acute Promyelocytic Leukemia (APML), a cancer of white blood cells that can affect patients at any time in their lives. Announcing this R Chandrasekaran said, "Arsenox is a significant advance in the treatment of patients with APML. These patients would already have tried the standard treatment available. Another positive aspect of Arsenox is its cost. At present the treatment for APML is out of reach for many people due to its high costs. Arsenox is now accessible and very affordable as compared to the regular treatment available. In fact, it will be one-tenth of the standard treatment's cost." Standard treatment available is with ATRA and anthracyclines. The cost of treatment using ATRA and anthracyclines ranges between Rs 6 lakh and Rs 8 lakh. NPIL looking at collaborations Nicholas Piramal India Ltd (NPIL), which has embarked on a focused R&D program in the areas of new chemical entity (NCE), new drug discovery system (NDDS), and process development, is looking at collaborations with the innovators instead of going for generics according to Ajay Piramal, chairman, NPIL. The NPIL chairman said that the company's track record and credibility in respecting IPR is extremely good and is respected globally. It is setting up a R&D facility in Goregaon, Mumbai spread over an area of 200,000 sq. ft. The new facility will focus on rheumatology and cancer research, apart from NCEs and NDDS. It is investing close to Rs 75 crore in this project, which will provide space for 400 scientists. One-third of the work has been completed. Besides, it has a small R&D center in Chennai and is planning to set up one more in Bangalore. NPIL is making forays into biotechnology in key therapeutic areas for which it has formed global alliances. Recently, it signed an MoU with Biogen Inc. to market Avenox in India. The product, which was launched in January 2004, has fetched it Rs 5 crore in sales and NPIL is very bullish on this product. Vijay Shah, chief operating officer, informed, "We are looking at launching other therapeutic products in India and are discussing with global players in this regard. NPIL is poised to take advantage of the opportunities that will emerge in the bulk activates and intermediates market for contract manufacturing at attractive price points, for both on-patent and of-patent drugs." NPIL has also filed its first patent for its own NCE, an anticancer molecule NP102 in India and the US. â€¦ to set up research station in Rajasthan NPIL is setting up a small research station in Rajasthan to study the opportunities in plant biotechnology in the Thar desert. Dr Swati Piramal, director, strategic planning and communications, NPIL informed, "We are investing Rs 5-10 crore on this project. Dr Saran Narang, one of the world's most renowned molecular biologists, who is also on our Scientific Advisory Board, will head this project. Dr Narang will develop the research station and will bring his team to study the opportunities in plant biotechnology in Rajasthan. The whole project will commence by end of this year. It is expected to take two-three years to complete." Wockhardt sets up subsidiary in the US Wockhardt Ltd, having three biotech products in its basket, has unveiled plans to establish its own sales and marketing organization in the US to drive its business in the world's largest pharmaceutical market. "We are seeking an exponential growth in our US business over the next few years. Towards this end, we are beefing up the research and development, manufacturing, regulatory and legal infrastructure in India and establishing a sales and marketing organization in the US, " informed Habil Khorakiwala, chairman, Wockhardt Ltd. More than 150 professionals at various levels at Wockhardt in India are supporting the company's US generics' business by working on non-infringing technologies, filing Abbreviated New Drug Applications (ANDAs) and liaising with the US regulatory bodies. Arthur Maher, a marketing professional with over 20 years of experience in the generic pharmaceutical industry, has been appointed as president of Wockhardt USA Inc. to provide a new thrust to the company's US business. Wockhardt has also relocated Dr Sanjay Patel, president, corporate scientific affairs, from India to the US. He will guide Wockhardt's scientific and technical affairs in India, Europe and the US. Ramesh Sesha, senior vice president, intellectual property, has also been relocated to the US office. "With the growing consolidation in the US generics business, buyers now have fewer companies to deal with. The market is looking for new players with good credentials. Indian companies are now as much known for their quality as for their cost-effective prices. The timing is just right for Wockhardt for a push into the US, " said Maher. Rasi to launch Bt-cotton Salem-based Rasi Seeds (P) Ltd has became the first South Indian company and second company nationally to receive approval from Genetic Engineering Approval Committee (GEAC) for commercial cultivation of RCH2 Bt (bacillus thuringiensis) variety of cotton seeds developed by Rasi. This approval extends for commercial cultivation in the central and southern parts of the country. It is launching Bt-cotton seeds from this kharif season. Jaikumar, vice president, marketing, Rasi Seeds informed, "Rasi Seeds will release approximately 3 lakh packets of Bt-cotton in six statesâ€” Andhra Pradesh, Gujarat, Karnataka, Maharashtra, Madhya Pradesh, and Tamil Nadu at the prevailing market price, i.e., Rs 1,600 per packet. Rasi Seeds has taken four years to launch Bt-cotton seeds in India. Jaikumar is optimistic about the growth of the Bt-cotton market in India. He said, "The market is very positive, as this will benefit the farmer by reducing the cost of insecticides, reduce pollutions due to use of insecticides and also increase the yield of cotton." It may be noted that last year the GEAC deferred a decision on the application of Rasi Seeds, a sub-licensee of the Bt cotton technology which was acquired by Mahyco from Monsanto, USA, for seed production of transgenic cotton hybrids, namely, RCH-134 and RCH-138 in an area of 200 hectares for Kharif 2003 Northern RCH- region because of non-availability of basic data. India has $2 billion R&D opportunity to tap: Jasti With global pharmaceutical leaders looking at outsourcing their research activities to India, the opportunity in R&D sector is worth $2 billion. "But there is hardly any major coordinated activity on this front," said Venkat Jasti, managing director, Suven Life Sciences. As a small step in that direction, Suven and two other organizationsâ€”Chennai-based Shasun Chemicals and Drugs Ltd and Mumbai-based Innovasynth Technologiesâ€”have formed an alliance called Life Sciences Alliance in March last year with Austin Chemicals, USA, to win contracts for R&D activities. "The aim of the alliance is to provide a platform for both Indian and international pharma majors to discuss issues, which are coming in the way of getting the orders. The alliance is an effort in integrating capabilities and synergies of pharmaceutical companies from the US and India to help globalize pharmaceutical drug development process," said Jasti. Dr B Sahu, president and CEO, Innovasynth Technologies noted that India could become the best choice for drug discovery companies based out of the US and Europe. These companies are eager to leverage on Indian talent to reduce the time and cost involved in the drug discovery process through collaborative efforts with the Indian companies. However, ethical, environment, and IPR issues are coming in the way. "But as India is a signatory of the WTO agreement and has to implement the patent rules with effect from January 2005, the government would act upon it. This would support the companies in getting the orders in discovery development and process," Sahu added. Taiyo to invest Rs 40 crore Taiyo Lucid Pvt Ltd, a joint venture between Mumbai-based Lucid Colloids Ltd and Japanese Taiyo Kagaku Co Ltd is building a state of art manufacturing plant at Aurangabad in Maharashtra. The new plant will manufacture water-soluble dietary fibre and other nutritional products and ingredients. Taiyo Lucid is investing about Rs 40 crore in the first phase of the project. The Japanese company is providing the proprietary technology. The plant will go into commercial production in June this year. This new venture will come out with value added products, as Lucid was earlier only exporting the raw materials. Taiyo Kagaku will globally market the products under its brand name of Sunfiber through Novartis Nutrition and Novartis Consumer Health (licensees of Taiyo) in the US under its brand name Benefiber. Both these are natural products, manufactured from agro raw materials, which grow mainly in India and are widely consumed as a vegetable throughout the country. Suven's revenues up by 27.76% Suven Life Sciences' total income for the 12 months ending 31 March 04 stood at Rs 51.71 crore as compared to Rs 46.99 crore for the corresponding period of previous year. Export revenue in the current year registered 13 percent growth and increased from Rs 31.03 crore to Rs 35.13 crore. Praj Industries' net up by 245% Praj Industries Ltd has recorded an increase of 244.63 percent in its net profit for the year ended 31 March 2004 to Rs 8.34 crore as against Rs 2.42 crore in the previous year. The income from operations of the biotechnology solutions grew by 24.21 percent to Rs 109.49 crore in 2003-04 as compared to Rs 88.15 crore in the last fiscal year. Alfa's net up by 56% Alfa Laval has recorded a 56 percent growth in its net profit for the quarter ended 31 March 2004. Its profits stood at Rs 23.47 crore as against Rs 15.09 crore. The company also recorded an increase of 29.54 percent in its income from operations to Rs 115.89 crore in the period compared to Rs 89.46 crore the same quarter the previous year. Lupin to commence Phase-I trial for psoriasis oral treatment The Mumbai based Lupin Ltd has got the approval for the commencement of Phase-I clinical trial of its investigational new drug candidate LLL-3348 (Desoris) from the Drug Controller General of India (DCGI). Desoris is orally bioavailable and proposed for the treatment of chronic stable plaque type psoriasis, the global market for which is estimated to be over $3 billion. "Lupin is one of the few companies to get an Investigational New Drug Application (INDA) approval for New Chemical Entities (NCE). The approval is a testimony to Lupin's world-class R&D. It marks a significant step in Lupin's long-term strategy towards becoming an innovation-led transnational pharmaceuticals company," Lupin chairman Dr Desh Bandhu Gupta said. "There is an imperative need for effective and safe drugs to be made available in global pharmaceutical market for this chronic inflammatory skin disorder. In addition, the side effect profile of existing drugs leads to marked reduction in patient's compliance, " said Dr Sudershan Arora, president-NCE, Lupin Ltd. Desoris is an herbal aqueous extract that acts through a novel mechanism of action that effectively modulates the cellular function leading to a marked psoriatic lesion improvement without any toxic effect. Lupin has developed this product in the form of capsules. Lupin has already accomplished the therapeutic evaluation and safety profiling of the herbal extract and will start the Phase-I clinical trials shortly. Based on animal data, Desoris has been found to be efficacious and safe. Animal pharmacokinetic data suggests that the botanical Desoris could be used once a day. This is Lupin's second INDA based on herbal R&D, which has been approved. Prior to this, Lupin's INDA for the prophylactic treatment of migraine was approved by the DCGI in December 2003. Glenmark's GRC-3886 to enter Phase-I clinical trials A team of scientists at the New Drug Discovery Centre of Glenmark Pharmaceuticals Ltd, a $100 million Indian market leader in therapeutic segments like dermatology and respiratory, has discovered a novel, potent and highly selective drug candidate for Chronic Obstructive Pulmonary Disorder (COPD) and asthma. Glenmark Pharmaceuticals is currently completing its pre-clinical studies for the compound, GRC-3886. The compound having demonstrated high efficacy and safety in pre-clinical studies is expected to enter Phase-I clinical trials in the UK in July 2004. The Phase-I clinical studies will be conducted by Quintiles, a leading global Contract Research Organization. With this, Glenmark has also decided to move GRC-3886 ahead of its previous PDE4 inhibitor GRC-3015. Glenn Saldanha, MD and CEO of Glenmark Pharmaceuticals, said, "Comparative pre-clinical animal studies indicated that GRC-3886 has a better efficacy and side effect profile than Roflumilast, Cilomilast and Rolipram". GRC 3886 is claimed to be a highly selective inhibitor of the human PDE4 enzyme that is associated with the COPD and asthma disease conditions. GRC 3886 has shown very promising results in the preclinical studies that spanned two broad phasesâ€”in-vitro studies and in-vivo studies (conducted on animal models). Akorn, Strides sign MoU Akorn Inc. and Strides Arcolab Ltd signed an MoU to market products for the US hospital market. This will be accomplished through a 50:50 joint venture company (JVC) between Akorn and Strides. The JVC will outsource from Strides an exclusive product pipeline of grand fathered and ANDA products in finished dosage forms including liquid injectable, lyophilized, powder fill parenterals and soft gel capsules and tablets. And from Akorn sales, the JVC will outsource marketing and distribution capabilities for the US hospital and US retail markets. The ANDAs developed for the JVC by Strides will be owned exclusively by the JVC. Currently, Strides has a total of 12 manufacturing plants worldwide. It is expected that four plants in India, including a new facility for Cephalosporins that is expected to be commercialized by the fourth quarter of 2004 will address the JVC's manufacturing needs to ensure cost-effective manufacturing. The JVC is targeting launches of grandfathered products in the US by the first quarter of 2005 and plans to begin ANDA filings by the end of 2004. Arun Kumar, managing director and group CEO, Strides said, "The Akorn and Strides JVC is a true reflection of the Strides partnership philosophy. Using our niche manufacturing and product development skill sets, Strides will ramp up its ANDA strategy for the US hospital market with the resources provided by Akorn to reduce the time-to-market." Taiwan keen on BT in India Taiwan with $206 billion forex reserve is seriously looking to invest in India and increase the two-way trade from the present $1.39 billion in 2003, said Huey-Ching Yeh, secretary general, Ministry of Economic Affairs (MOEA), Taiwan. Yeh, who is leading a nine-member business delegation to India, said that Taiwan's forex, which is the second largest in the world, was keen to enhance mutual benefits through building official channel for economic consultation with India. Addressing an industry gathering, organized by the Confederation of Indian Industry (CII) he said that the outlook of India-Taiwan economic relations should be to build comprehensive economic relations and create a win-win situation between India and Taiwan. R Vishwanathan, joint secretary (Investment & Trade Promotion), Maharashtra, said that there has been a paradigm shift in the minds of Indian people. They are more confident and are willing to go global. VK Mathur, chairman and managing director, Inapex Ltd, said, "India offers opportunities to re-locate in a competitive setting and simultaneously, India can be Taiwan's natural partner in knowledge-based industries and develop synergies in hi-tech areas." DaimlerChrysler interested in Biodiesel Its not only the Indian organizations like railways and HPCL, even the world's oldest automaker DaimlerChrysler has embarked on a project to prepare biodiesel from the extracts of ''jatropha plants'' as a viable alternative to the conventional energy. It has been working on the project in association with the Hohenheim University, Germany, and the Council for Scientific and Industrial Research of India. It had established two small plantations on eroded land in two climatic regionsâ€”sub-humid (Orissa) and semi-arid (Gujarat). These Jatropha curcas oil seed tree plantations were expected to recover eroded soils and render them usable for agricultural purpose again as well as to produce bio-oil that could be used for biodiesel production. The five-year project was launched in 2003 and had been broadly divided into three phases. In the first phase a test drive of a Mercedes-Benz C-class car was on the biodiesel for over 5,000 km and at the end of the drive conclusive facts would be drawn about actual reduction in pollution and the fuel's adaptability to different climatic conditions. GeneTech diversifies Hyderabad-based GeneTech is in an expansion mode. The five-year-old diagnostics company after making a name of itself in cytogenetics, molecular genetics and biochemical genetics is expanding its area of activity to include pharmacology related contract research and is in negotiations with some biotech companies for the same. Looking at the wide opportunity in the gene expression area, GeneTech founding director Dr Anuradha Udumudi said, "The company is looking beyond medical genetics to pharma genetics. We have been focused on diagnostics so far but now we are reorganizing resources to include contract research and training." Ocimum unveils iRNAwiz Ocimum Biosolutions announced the launch of its niche product "iRNAwiz", a comprehensive and intuitive tool for the design of siRNA on its third birthday. The tool provides the user with flexibility to define his own search templates, set regions of interest based of wide variety of criterion like ORFs, UTR regions, introns and exons, secondary structures, motifs and domains, and post design analysis of successful siRNA. Anuradha Acharya, CEO, Ocimum Biosolutions said, "We are very excited. We provide scientists with the essential tools and analytics necessary to speed up and manage their research efficiently. We believe that scientists will be able to significantly speed up their research in the field of siRNA design." Bhat Bio-Tech ISO certified Bhat Bio-Tech India (P) Ltd has received the ISO 13485 : 1996 Certificate from UL India Private Ltd. With this, Bhat Bio-Tech is believed to be the first diagnostic and biotech company in India to receive this certification. ISO 13485 is the certificate for medical devices, which is the prerequisite for getting CE marking and US FDA approvals. Dr Shama Bhat, CMD, Bhat Bio-Tech, described the growth of BBI, from one product in 1996 to more than 60 products in 2004 as a significant achievement. The company plans to get into biopharmaceutical products too. ]]> <![CDATA[IP audit is vital for success]]> https://biospectrumindia.com/news/95/6100/ip-audit-is-vital-for-success.html https://biospectrumindia.com/news/95/6100/ip-audit-is-vital-for-success.html Tue, 11 May 2004 18:40:00 +0530 A periodic IP audit would help to explore and exploit many of the intangible assets, the company may have or periodically develop. One has often heard of tax or financial audits, which are normally carried out by companies. A company engaged in creative, ingenious and resourceful in-house research and development activities with large intellectual interest should consider conducting an audit of Intellectual Property (IP), which covers patents, copyright and trademark. A periodic IP audit would help to explore and exploit many of the intangible assets, the company may have or periodically develop, which can be a good source of income and capital in a well-policed IP regime. An audit of IP should focus on three particular areas of potential risk: First, an audit should analyze the adequacy of intellectual property protection for existing products. Second, it should anticipate claims of intellectual property infringement. Third, an audit should cover a review of all relevant documents related to employee contracts, copyrights and licenses. Intellectual Property Rights (IPRs) are increasingly becoming recognized as vital assets of the business and protecting IPRs are critical in the successful running of a business. The fast-changing landscape is demanding of corporates and nations to continuously build and extract maximum value from their intellectual assets. Proper management of intellectual assets has been hampered by the marked absence of standardized and systematic tools for their valuation. Lack of appreciation of IPRs at the organizational level and its pivotal link with business processes are the key reasons for IPRs not figuring in the priority agenda of managements. This will need urgent and orchestrated attention. A lot of companies, which set up R&D centers, develop great quantities of R&D data. However, patent awareness or consciousness leaves a lot to be desired. It bears to emphasize that more training regarding IP rights is requisite in order to form a new mentality about IP rights and their importance. Once the importance of IP in companies that carry out R&D activities is better appreciated, policies and procedures for "harvesting inventions", as very aptly the Japanese call it, should be established. Issues Due Diligence of existing IPRs: Companies should carry out due diligence of existing IPRs and analyze the adequacy of IP protection for existing products. A company's best efforts to safeguard its assets cannot always prevent others from stealing or damaging them. Periodic patents and trademark searches should be carried out. If the company's IPRs are infringed upon, the company would need to protect its rights through litigation, as failing to litigate could waive its exclusive rights to those assets. Litigation can be used to enjoin infringement and to challenge anti-competitive behavior resulting from the misuse of IP by a competitor. India's IPR laws The law in India relating to IP and to the protection of the right of its exploitation and use comprises: Patents Act, 1970 (as amended by the 1999 and 2002 Amendment Act) Patent Rules, 1970 and 2002 Trade Marks Act, 1999, Copyright Act, 1957(as amended by the 1983 and 1994 Amendment Act) Designs Act, 1911; Geographical Indication Act, 1999 Protection of Plant Varieties and Farmers Rights Act, 2001 and Rules 2003 India being a signatory of TRIPS in 1995 is now bound to amend its existing laws to meet the requirements of the agreement. In order to make it TRIPS compliant, the government has initiated action to bring in the requisite changes. In the last few years, India has brought about amendments to the above laws or enacted new laws. The survival of the biotechnology industry would depend on the strong intellectual property protection, which is essential to their success. In general, patents protect inventions of tangible things; copyrights protect various forms of written and artistic expression; and trademarks protect a name or symbol that identifies the source of goods or services. IP rights generally grant the IP owner the right to prevent others from using their IP for a fixed term within a particular jurisdiction. IP rights are generally enforced by suing infringers in the jurisdiction in which the infringing action occurred. Registration of IPR: For every new product, process or literary work developed by the company, the company can secure its legal rights to these assets by registering the IPRs emanating from such assets. Licensing agreements: A company may wish to allow others to use its IP, but would want to retain both its ownership and ultimate control over its use. In such an event a company may consider a licensing agreement. Maximizing Business Value i) Patents: A company should review its patent portfolio from time to time. Income from licensing of patents can be a source of sizeable revenue. The company should identify the patents that are of value to the company's core business. Those that have no value as marketable concepts in the near future should be abandoned. A periodic review benefits the company, as it would help reduce renewal fees and boost licensing revenues. Probably, few things are as frustrating, or embarrassing, or potentially career-threatening as creating, or having created for you, a valuable piece of intellectual property, only to find that you lost it or, perhaps worse, don't own itâ€”it is owned by someone else. ii) Trademarks: Trademarks are valuable assets of the company. The company should carry out policing and monitoring activities of others in the trade to ensure that there is no improper use by another trader of a deceptively similar mark. The company should review advertising, packaging and other documentation before distribution, in order to ensure compliance with trademark rules and practice. The company should also assess the status and value of marks owned by the company. Most times the marks are valued only when it is being considered for sale. The company should also consider whether its mark is worth renewal and maintenance if it is not being used. Entering into Contractual Agreements: A company would do well to protect its IPRs by executing agreements with employees and contractors. These agreements include: i) Confidentiality Agreements: In IT and in biotechnology related contracts, confidentiality is an important factor. Employees should be prohibited from disclosing or using private company information. Whether it is a separate agreement or part of a larger employment contract or invention assignment agreement, employees at all levels should be made to sign a confidentiality agreement promising that they will not use or disclose the company's confidential information without authorization and will exercise care to prevent the unauthorized use or disclosure of such materials by others. When hiring employees who once worked with a competing company or otherwise had access to a competitor's trade secrets, it is essential to inform that employee that he or she must not disclose or use any of the competitor's trade secrets. Where possible, a company should obtain a copy of any nondisclosure agreement between the new hire and his or her former employer. ii) Non-Compete agreements: The biotechnology industry is a highly competitive industry in which companies often poach employees and expertise from their business partners in order to better their own commercial prospects. Companies should enter into non-compete agreements with its employees and contractors. Contractually, the parties are bound to agree to refrain from engaging in any activity that may be construed as being competitive with that of the other party during the term of the contract. Such restrictions may be imposed on the parties during the term of the agreement. Internal Procedures: To protect its non-registered trade secrets the company needs to have internal procedures in place to prevent access to that trade secret information beyond those that need to know. A company should adopt the common procedures: The developers of IP should keep daily records of what is being developed. The company should ensure that a consistent message is used and inadvertent disclosure is avoided. In addition to requiring employees to sign the appropriate agreements, it is helpful to find creative ways to make employees aware of the importance of protecting company secrets and to demonstrate how easily trade secrets can be inadvertently disclosed. As with all company policies, trade secret policies should be reviewed and acknowledged by employees annually. One should make sure that intellectual property is available only to those who are authorized, and is protected from loss and corruption. So every company owns and uses intellectual property. IP due diligence is a vital part of any business transaction and should be given the same level of attention as reviewing financial information, tax documentation, and real estate documentation. Companies must realize that the continued operation of their business may depend on obtaining the proper and necessary IP. Unfortunately, not every company recognizes the importance of fully protecting these assets. By following the above guidelines, a company may be able to avoid some of the pitfalls facing intellectual property owners. Kirit Javali Partner Law Offices of Jafa & Javali ]]> <![CDATA[Angling for Take Off]]> https://biospectrumindia.com/news/95/1327/angling-for-take-off.html https://biospectrumindia.com/news/95/1327/angling-for-take-off.html Tue, 11 May 2004 18:08:00 +0530 Clinical Trials Development times for drug discovery not speeding up. Fewer trials included in the dossiers. Number of subjects showing little variation in recent years. Fewer bigger trials take the same time as smaller trials. Getting more drugs in the market in a shorter period remains the challenge These have been some burdens for big pharma companies globally. These companies are increasingly considering outsourcing and off shoring their drug discovery processes, R&D and clinical research. And Clinical Research Organizations (CRO) want to tap that opportunity. But with costs and speed being the key concerns, India is emerging as an important destination for obvious reasons like talent pool, facilities, large and diverse patient pool, qualified doctors, and many more. Today, global companies are not asking a question as to if they should consider off-shoring to India, but which phase of the drug delivery process in order to derive the maximum value. The number of companies participating in clinical research and trials is going up. Recently, the Genetic Engineering Approval Committee has given green signal for a couple of companies like Novo Nordisk and Reliance Clinical Research Services to begin clinical research in India. If global big pharma are doing it, would the India pharma stay behind? Some Indian big pharmaceutical companies like Wockhardt, Lupin, and Sun Pharmaceuticals are working on new chemical entities and have established their own clinical research units to conduct trials for their new molecules. Slowly but steadily, clinical research and trials in India is getting ready for a big take off. Read on â€¦ Narayan Kulkarni with Ch. Srinivas Rao Full of promise Indian market is still unorganized. Compared with the global CRO market, the Indian CRO market is very small mainly because the companies are offering low-end services. Companies are doing bio equivalence studies, bioanalytical studies, and Phase-II and Phase-III trials. Dr Satish Bhatia, president, Wellquest, division of Nicholas Piramal India Ltd, observed that India's share is less than one percent of the global CRO market size of $10 billion. Global Trends Growth of offshore CROs (mainly India and South America) CROs rarely fail but some times they do e.g., Oread Still not a highly profitable business Looking to diversify out of drug development Now viewed as service stocks not growth stocks with resultant lower valuations and less orientation Little consolidation in CROs Source: Technomark The industry is divided when it comes to estimating the market size. But most of them believe that the present Indian CRO market is in the range of Rs 200-250 crore. Few say, it is in the range of Rs135-150 crore, while Dr Ajit Nair, senior manager strategic planning and clinical operations, SIRO Clinpharm, the first Indian CRO to commence trials in 1996, puts the figure at a much higher side of Rs 550- 600 crore. There are about 25 CROs working in India with many pharma companies having their own clinical research units conducting trials in 80 odd government and private owned hospitals. Going with the industry, Surinder Kher, senior vice-president, iGATE Clinical Research International Pvt Ltd, said that the present CRO market size should be approximately Rs 200-250 crore. This includes the clinical trials conducted by the independent clinical research organizations, the clinical research outfits of multinationals like Eli Lilly, Pfizer, Novartis, and Aventis and some in-house clinical research is being done by Indian pharma majors. Kiran Mazumdar-Shaw, CMD, Biocon and president ABLE said, "Currently according to the Organization of Pharmaceutical Producers of India (OPPI) statistics, Indian CRO business is worth $70 million growing at 30 percent annually. The Indian advantage in clinical development is clearly the speed of patient enrolment and thereby shorter time-lines for clinical trials." According to ABLE estimates, Indian clinical research and development business is expected to grow to $1.5 billion by 2010. What is heartening is that companies now are getting more focused. For example, Wellquest is focused on clinical research to support introduction of generic and NDDS products. Dr Bhatia informed, "Soon it would be followed by Phase I-III trials for NCEs." Wellquest that has got three accreditations and done 40 studies was able to garner revenues of Rs10 crore for the year 2003-04. Spending Trail Phase-I Rs 50-55 crore Phase-II Rs 60-65 crore ($15-20 million) Phase-III Rs 130-135 crore ($30-35 million) Source: Ernst & Young 2002 report Synchron Research Services, offering services in Phase-I, high throughput screening for rapid PK analysis, qualitative and quantitative medical imaging, in silico drug metabolism studies, was able to garner Rs 5 crore for 2003-04. It has conducted 200 bioavailability and bioequivalence studies and six studies in Phase II-IV. Commenting on the focus areas of SIRO Clinpharm, Dr Ajit Nair said, "Clinical project management and data management are of immediate focus and will continue to be the mainstay, with innovative solutions for convenience and cost-efficiencies in these areas being the key differentiators in the future. The vision is to move from being only an outsourcing agent to being a partner who can contribute in minimizing the drug development risks while maximizing competitive advantage." This has brought in more revenue to the company and was able to add Rs 31 crore in 2002-03. Lotus Labs in 2003-04 has been very aggressive. Recently it announced to set up a 50-bed facility in Chennai to conduct clinical trials, bio studies and the center is expected to be operational in six months. "Lotus is spending Rs 1 crore on this. Over the past 36 months, we have conducted over 300 biostudies. We plan to build a separate facility in St John's Hospital to conduct Phase-I trials in-house at an investment of Rs 2.5 crore," informed VV Raghavan, managing director, Lotus Labs, on his company's current developments. The company is talking to Shantha Biotech to conduct Phase-III studies of the latter's erythropoetin. Lotus Labs is also in the process of setting up training centers in good clinical practice and good laboratory practice. Lotus Labs expects to touch Rs 14 crore during 2003-04. ClinInvent Research Pvt Ltd has adequate staff for monitoring, project management, and quality assurance and has the backing of The Chatterjee Group. Dr Arun Bhatt, president of the organization, ClinInvent Research, said "Our focus is on all phases of clinical trials mainly in the areas of oncology, neuro-psychiatry, cardiology and diabetes drugs." Leading CROs in India Accutest Research Laboratories Apothecaries Clinical Research Asian Clinical Trials Biocon Clinigene International Clin World ClinInvent Research ClinTec International Diagno-search Eli Lilly GVK Bioscience ICON Clinical Research IGATE Clinical Research Lamba Therapeutic Research, Synchron Research Services Lotus Labs Novartis Pfizer Quintiles Spectral Reliance Clinical Research Services SIRO Clinpharm Therapeutic Drug Monitoring Lab Vimta Labs Wellquest Pharma companies like Dr Reddy's Labs, Lupin, Panacea Biotec, Ranbaxy, Sun Pharmaceuticals, and Wockhardt are also working on clinical research sector. Companies in Information Technologies Cognizant Technologies, Eassar Technologies, HCL Technologies, IBM India Ltd, Infosys, and TCS are keen on making investments on data management. Referral laboratories such as Dr Lal's Lab, Metropolis Health Services, and SRL Ranbaxy are offering clinical trial services Vimta Labs, which operates in the areas of testing and validation, clinical research, clinical pathology, pre-clinical safety evaluations, environment assessment, and inspection and certification services, has seen 81 percent growth in its revenues over that in the previous fiscal. It ended March 2004 at Rs 35.11 crore in income. Clinigene International, a Biocon subsidiary, offers clinical, bio analytical, bio statistical and data management services to its clients. Said AS Arvind, chief operating officer, Clinigene, "We concentrate on Phase-Iâ€“IV clinical trials, bioavailability/bioequivalence studies, and data management." The company has recently inaugurated a state-of-the-art human pharmacology unit at Sagar Apollo Hospital. This unit is spread over 3,000 sq. ft and can accommodate 26 volunteers at a time. The Indian arm of the American pharma giant Eli Lilly & Company is putting its concerted efforts in conducting clinical research by partnering with key thought leaders and experts in the therapeutic areas. Working with over 40 hospitals in India, including government and private hospitals, Eli Lilly (India) has 17 large and small clinical research projects running involving both phase II and III trials. Quintiles Spectral (India), a subsidiary of Quintiles Transnational, leads the segment in India with turnover of more than Rs 38 crore for 2002-03. It is conducting clinical research involving more than 70 research sites and involved in over 40 research projects for 20 different pharmaceutical companies. India is taking this opportunity seriously. And it has to as it has immense potential. "India due to lack of penetration of drugs has a huge patient population that has never been subjected to any drug and this gives a critical pool of naÃ¯ve, uncontaminated patients which is important in conducting certain development work and clinical trials. Significant population biodiversity in India with its wide and varied gene pools can provide wealth of information for target identification, a key for the CROs," noted Alok Gupta, director, life sciences, Rabo India. "India will gain by researching diseases. The cost of clinical trials is 50 percent lower in Phase-I, 60 percent lower in Phase-II. Cost saving is not the only advantage. Ability to find and qualify the right patient pool is an appealing factor for Indian trials, and India also offers genetically and culturally diverse population where treatment-naive patients are willing to participate in trials. For all this to happen, we have to be an ethical community," added Mazumdar-Shaw. Nascent sector's woes Issues confront this sector too. The awareness about mega CROs opportunity is familiar topic these days. But this does not mean that the industry is not confronted with hurdles. Indian companies have their own share of woes while conducting the trials on human beings. This, the industry says, is mainly because there is no clear regulatory framework, which would support and encourage the companies to take up human trials in proper manner. Dr Ajit Nair observed that the regulatory (DCGI) approval timelines in India are high as against the US. While it takes about 30 days in the US, here it is about 90-120 days. This puts a crimp in the project timelines. However, more often than not, this is made up by the enrollment timelines, as the enrollment rates in India are mostly higher than most developed nations. Expressing the same views, Dr Arun Bhatt of ClinInvent Research noted that lack of trained manpower, GCP culture, working of the independent ethics committees, regulatory uncertainties are coming in the way for the growth of the segment. According to Dr Shiv Prakash, managing director, Synchron, "The Indian CRO industry is still in an unorganized sector and regulatory approvals take long time. Maintaining confidentiality of data (data protection) is key issue before of the segment." Key ICH Rules All clinical research data should be recorded, handled, and stored in a way that allows its accurate reporting, interpretation and verification. (ICH GCP 2.10, 4.9, 5.5, 5.14 and ICH E9 3.6 and 5.8) Systems with procedures that assure the quality of every aspect of the research should be implemented. (GCP 2.13) Quality assurance and quality control systems with written standard operating procedures should be implemented and maintained to ensure that research are conducted and data are generated, documented and recorded, and reported in compliance with the protocol, GCP and applicable regulatory requirements. (GCP 5.1.1) If data is transformed during processing, it should always be possible to compare the original data and observations with the processed data (ICH GCP 5.5.4) Sponsor should use an unambiguous subject identification number or code that allows identification of all the data reported for each subject. (ICH GCP 5.5.5) Protocol amendments that necessitate a change in the design of the CRF, subject diaries, study worksheets, the research database and other key aspects of the CDM processes need to be controlled. (ICH E9 2.1.2) Common standards should be adopted for a number of features of the research such as dictionaries of medical terms, definition and timing of the main measurements, handling of protocol deviations. (ICH E9 2.1.1) Dr Bhatia noted that the Indian companies are not able to conduct the phase I trials for foreign sponsors as these are not allowed at present. And the delays in getting approvals from the DCGI for starting clinical trials (phase I-III) have to be sorted out immediately. Further, " The challenges that are confronting the segment are the unstructured environment in hospitals and government institutions, lack of GCP awareness amongst the large institutions, and regulatory environment which is not well defined for all aspects of research," pointed Rajiv Gulati, managing director, Eli Lilly (India). Dr Swati Piramal, director, strategic planning, Nicholas Piramal India Ltd said that the most worrying factor is outsourcing by Indian pharma companies for Phase-I clinical trials when Indian companies are capable of doing the same at a lesser cost are looking at MNCs to outsource their R&D work. She informed that this might be due to data protection, regulatory fear and delay in getting the approvals. Companies are working on how to protect the data. Dr Piramal said that Nicholas Piramal is discussing the issues like data protection, data security with Infosys Technologies. Considering that CROs in India have a good potential and scope for attracting outsourced R&D, Ranjit Shahani, managing director, Novartis India Ltd, pointed, "The main hurdle will be the absence of data protection. Hopefully, there may be clarity and some positive policy framework that should be established by the end of 2004. Some of the other barriers include: absence of a clearly laid down time frame for permission of clinical trials and difficulties in custom clearance of clinical trial samples." What do the outsiders think? Dr William A Haseltine, founder and former chief executive officer, Human Genome Sciences, who was there recently in India, told the biotech forums, "India can partner early with companies, take the products through clinical trials and develop them. But there are issues of ban on Phase-I clinical trials of outside drugs and pharma companies face problems in getting animals for testing. Both of these issues should be solved politically. Also for clinical trials, hospitals records need to be automated and the general infrastructure needs to be improved. India is an attractive destination for outsourcing because of the trust that the western countries have in it." Dribbling the tribulationsDribbling the tribulations Industry gets proactive. For every problem there is a solution and problems cannot go all alone. The industry has come up with several suggestions to address the matters. The suggestions include formation of professional and independent ethics committees, which can speedily provide reviews of protocols and informed consent forms. Formation of a bank of volunteers (female and male). Sticking to the ICH-GCP guidelines, which is the preferred guideline. Last point is the one, which every CRO echoes vehemently. "The role of a CRO is to monitor and see that investigators are complying to ICH-GCP practices," informed Shamiq Hussain, general manager, ClinTec (India). He felt that the industry should now collectively promote the awareness on the internally practices as this will help the industry to win many projects. Dr Ajit Nair too feels the same. "If all clinical trials were to be conducted as per ICH-GCP, then we should not foresee any controversies. But what we need to make people understand is that, all humanly possible precautions are taken by the sponsorer, regulatory agencies, CRO independent ethics committee and other clinical trials-related bodies to minimize the risk to a patient during the trials. Hence media education about trials and the ethics is must. Future is great if the correct purpose and intent of trials is passed on to the media and regulators." Dr SP Vasireddi, chairman and managing director, Vimta Labs has his share of suggestions, which would help the segment to grow vertically. "Organizing campaigns like AIDS/HIV awareness programs to educate the people about the benefits of becoming the part of the clinical trials, establishing strong relations with academia and industry (both pharmaceuticals and IT) to get the trained manpower through tailor made courses that are accepted and recognized by industry. These measures will definitely bring in some relief to the segment." Ranjit Shahani of Novartis India has come out strongly in support of key policy incentives that can strengthen the role and contribution of CROs. His recommendations being: Incorporation of a five-year "Data Protection" clause, as is done all over the world, preferably in Schedule "Y" of the Drugs Act; A regulatory framework harmonized with international regulatory practices. Incentives for setting up CROs through tax reliefs and infrastructural facilities at concessional rates; Government to fund and set up a campus (park with common facilities), which can be leased to CROs (Singapore Model); Institutionalize linkages between universities, research laboratories and industry; Inbuilt incentives to hospitals for participating in clinical research; Weightage for experience in "clinical research" in promotion of Medical Teachers; Facilitating Venture Capital; Incentivizing introduction of new advanced technologies to be used by CROs like Gene microarray expression profile analyses, computer-aided validation systems, direct connect web portals, in-house laboratory information system, and interactive voice response systems. For the growth of any industry, besides the efforts of the companies, government support in the form of incentives, duty reduction/exemption will make difference. What does the CRO segment expect from the government? The industry is looking at reduction in import duty on research equipment, make import of requisite equipment duty free, financial assistance to the entrepreneurs who are entering into CRO industry in form of funds or subsidy, tax benefits in the initial growing stage, make the earnings from R&D tax free, issuance and strict enforcement of guidelines, good audit system and single window clearance. Swaminathan Subramaniam, chief executive officer, Sanmar Speciality Chemicals and ABLE Special Interest Group member, brought out some more dynamics associated with the contract research services. "Since research services is about delivery and life services are related to IP intensive industry, the government has a very responsible role to play in facilitating the industry. India needs to be promoted as a research services destination rather than research product destination; there is no mechanism or standard for contract sharing; the IP environment is confusing; the industry needs to collaborate with the academia. There has to be a code of conduct for biotech members (especially research services)." Meanwhile Dr Shiv Prakash pointed out that self-regulated CROs with commitment to quality and ethics are not foreseeing any problems of growth despite certain controversial issues. Besides there are many investigators who are not GCP trained but are highly inclined to get involved in conducting clinical trials and such enthusiastic investigators, if trained for GCP will create an ocean of good investigators for almost all indications. "Instead of creating the perception of controversies, we need to focus on how best can we contribute to this science? Individuals and organizations involved in this science need to work together to overcome the challenges that we face in this area to become globally recognized. We need to recognize that every new industry takes time to develop and mature. This industry is just in infancy and challenges will be there. We know that there are certain areas where we need improvement but we need to be a part of the solution rather than being part of the problem and get away from unnecessary controversies," noted Surinder Kher. India getting noticed The world is watching India quietly. There has been a concerted effort to make thingswork. In fact, "International bodies like NIH are taking notice of the potential. Universities like John Hopkins are looking at India," DA Prasanna, executive chairman, Manipal Education and Medical Group India Pvt Ltd, pointed out. He added that one or two variables are not successful clinical research, but consistency is what matters. Increasingly, there has been a trend towards forming alliances, educational institute-industry collaborations, and hospital-CRO alliances. Take for example Manipal. It has a very strong medical research activity. It wants to use the CRO opportunity to fund its research activity. Recently, it tied up with Quintiles Research, whereby the Manipal Group will be the preferred research partner for Quintiles in India, Nepal, and South East Asia for clinical trials. Quintiles will have access to Manipal's integrated platform of clinical material across its six campuses. "This agreement provides the platform for accelerated clinical research supporting effective drug discovery and launch," said Sachin Rajan, vice president, diagnostic services & clinical trials, Manipal Hospital, Bangalore. Further, there will be Quintiles certification for those involved in the clinical trials. Another trend has been that hospitals, which have huge space, are letting the CROs build labs too. For example Lotus Labs has tied up with St John's Hospital in Bangalore for building the facility. Similarly, Sagar Apollo has given a floor in its Hospital to Clinigene. A lot of information technology companies and referral labs are showing keen interest to expand their activities by taking up clinical research and data management projects. Novartis India, an MNC is investing $1 million in setting up IT development center in Mumbai with a headcount of 60 to co-ordinate its drug discovery and development process. Iso Moshfegh, global head of development IT, Novartis Pharma AG informed that this center will help reduce the drug development cost by $42 million. This is the opportunity one has to look at. The opportunities are also there in data management, report writing, animal toxicology which are part of the clinical research. One should not be totally carried away. While making a presentation on the global CRO trend in Mumbai Dr Graham Hughes, scientific director, Technomark Consulting Services, UK, observed that the pharma industry in the US and Europe is under unprecedented pressure and it may not be in position to keep up its promises. But they are reluctant to change to different types of outsourcingâ€”tactical subcontracting and strategic outsourcing. So the CROs are feeling the knock on pressures. They should look at options that should come from topâ€“down. Also small companies have started forming alliances to tap the opportunity collectively. Life Sciences Alliance is an example of Shasun Chemicals and Drugs, Suven Life Sciences Innovasynth Technologies and Austin Chemical Company of the US coming together to get the contracts. The alliance members say it will be easy to convince the source if we are in group to meet their requirements. Also several educational institutes are actively looking at offering clinical trials courses. With a concerted and cohesive efforts, the industry is working towards seizing the opportunity. Mumbai to be the CRO hub of India Government of Maharashtra is proactive in leveraging its strengthsâ€”hospitals and trained people in medicine. It is looking at developing Mumbai, the financial capital of India, as a hub for Clinical Research Organizations. Its proximity to the western countries like the US, European Union and the International airport provide strong base for the government of Maharashtra to establish CRO hub at Mumbai. It has hired the services of McKinsey and Company to put down the strengths and loopholes to fill in. Dr Swati Piramal, member of the biotech council of government of Maharashtra, said that Confederation of Indian Industries' MahaBioYatra, state government, hospitals and academia are working together in this regard. Dr Piramal informed that 10 km radius around Parel in Mumbai has 6000 hospital beds. Reputed hospitals such as Jaslok, Hinduja, Bombay, JJ, KEM are located in and round Parel. And these hospitals are attached to academic institutions. The faculty at these have been practicing and doing the clinical trails for last 20 years but they are not aware of the opportunity and how to do it in professional manner. They need some training on issues like ethics, ICH GCP guidelines and working within the purview of the independent ethics committees. The biotechnology council of Maharashtra has taken steps to train the people in this sector. "We don't want to take any chances. Before commencing we want to assure that everything is on the track, including the trained people in CRO sector, " said Dr Piramal. University of Pune, located just 180 km from Mumbai, which has been offering courses in bioinformatics and biotechnology will shortly start offering courses in clinical data management. The process in this regard has already commenced. Prof. AS Kolaskar, vice chancellor of University of Pune who is eager and anxious to start a course in clinical data management, has conducted a program late last year to understand the opportunities in the industry and to get the feed back from the industry people. ]]> <![CDATA[Stay away from GM medicinal plants]]> https://biospectrumindia.com/news/95/1187/stay-away-from-gm-medicinal-plants.html https://biospectrumindia.com/news/95/1187/stay-away-from-gm-medicinal-plants.html Tue, 11 May 2004 18:07:00 +0530 Genetically modified medicinal plants are an ill-advised move. It has been reported that Jamia Hamdard's biotechnology centre has been given a grant by the government to develop genetically modified medicinal plants. This ill-advised move should be reversed immediately and the project stopped. Medicinal plants produce very special chemicals under certain specific conditions. These chemicals in the form of alkaloids or essential oils are usually the active principle in the plant, in other words, that compound or compounds which has the healing property associated with that particular plant. The efforts to broaden the base of medicinal plants that can be accessed for commercialisation on a large scale has led to the development of cultivation methodologies for medicinal plants that have been traditionally collected from the wild. Suman Sahai It is not surprising that developing cultivation packages have so far met with limited success. In fact, given the amount of money that the government is spending on this, the results are quite modest. Traditional Vaids and Hakims are in fact quite sceptical of the efficacy of cultivated sources of medicinal plants and advocate the use of medicinal plants from nature for effective cures. An important aspect of cultivation is to ensure that these medicinal plants are grown in conditions mimicking their natural habitats to the extent possible. It stands to reason that no agrochemicals are to be used, neither fertilisers nor pesticides. The reason for this is to create cultivation conditions similar to those under which the plant is provoked to produce these special chemicals in nature. Most of these chemicals are produced in response to environmental stress. For example, the agar tree produces the fragrant agar resin (used in agarbattis and the perfume industry) in response to a fungal infection. The impact of even the natural environment is acutely registered by the medicinal plant and influences the amount and potency of the active principle it produces under the given conditions. It is known for example, that populations of a particular medicinal plant from different parts of the country (and therefore from different habitats) have differing "medicinal value". Some are considered better than others and are more sought after. All these facts should help to make clear that medicinal plants cannot be "tampered" with if they are to retain their medicinal properties and remain effective constituents of treatment by the Indian Systems of Medicine (ISM). There is an abundance of studies being done on the impact of genetic transformation on the metabolism of a transgenic plant. All evidence points to the fact that metabolic changes can and do happen. The fear that allergens and toxins may be produced by the novel gene combinations resulting from the insertion of foreign genes into the germplasm of a plant, have led to the establishment of sophisticated protocols for testing food safety before a GM crop can be released for human use. The famous case of a GM corn, Starlink, produced in the US should be remembered for the fact that allergens can be produced in GM crops, the natural versions of which did not have any allergens. The genetically modified Starlink corn was found to contain an allergen and was therefore not approved for use as human food. A potentially life threatening allergenic property was found in a GM soybean variety bred by using a gene from the Brazil nut. Fortunately, this was detected in time, before harm could be done and the GM Soya was withdrawn. The outcome of putting in a radically different gene (from a completely different species) into a plant to create a GM plant remains uncertain largely because at the present level of the science, almost nothing is understood about the process of genetic transformation. The scientists cannot control where the new gene will go and sit on the chromosomes of the receiving plant, nor can they control whether one copy or 50 copies of the gene will be integrated into it. All this makes the process of genetic transformation a purely random event, the impact of which cannot really be predicted. In the case of non-edible cash crops like Bt cotton, something going wrong means a crop failure. In the case of food crops, it could have potentially harmful, even lethal effects for humans. In the case of medicinal plants, which have chemicals that heal but which could be considered dangerous in the wrong hands, the impact could be either that the plants lose the medicinal property or produce something unanticipated, which could have harmful effects. The news therefore that there is a project to genetically modify medicinal plants is disturbing. It reflects the mindless way in which the Department of Biotechnology (DBT) is promoting GM research, without any regard for relevance, appropriateness or even plain common sense. The DBT's recently retired secretary, now appointed as Advisor in the same department, is on record for famously insisting that India does not need a biotechnology policy, when practically every past and present luminary of the scientific establishment has expressed concern at the lack of such a policy. Well, this project is the result of working without a policy. There seems to be neither logic nor purpose in a project on GM medicinal plants nor in many other research projects promoted by the DBT. The DBT dispenses the taxpayer's money for research and the taxpayer has a right to help set priorities for GM research funded with its money. Personal whims for climbing on to the GM bandwagon and indulging a "Me-too" fascination on the part of a handful of people in the scientific establishment cannot substitute for a national policy on biotechnology, particularly genetically modified crops. India needs a sane and focussed policy for GM crops that should be developed after a national level stakeholder discussion. Dr Suman Sahai has a Ph.D in Genetics and has several years of research and teaching experience in the Universities of Alberta, Chicago and Heidelberg. Dr Sahai is a member of several national policy forums on environment, biotechnology and Intellectual Property Rights as well as education and health. She is also the convenor of Gene Campaign, New Delhi. ]]> <![CDATA[Swiss biotech industry VC flow at E83 million in 2003]]> https://biospectrumindia.com/news/95/2885/swiss-biotech-industry-vc-flow-at-e83-million-in-2003.html https://biospectrumindia.com/news/95/2885/swiss-biotech-industry-vc-flow-at-e83-million-in-2003.html Tue, 11 May 2004 18:00:00 +0530 According to a new study, the Swiss biotech industry attracted SFr 130 million in venture capital in 2003, compared to SFr 148 million francs in 2002 and SFr 106 million in 2001. In 2002 and 2003 Switzerland ranked third in Europe in terms of venture capital, which flowed into the biotech industry. The first Swiss Biotech Report was prepared by E&Y, SWX Swiss Exchange, and the State Secretariat for Economic Affairs, the Innovation Promotion Agency KTI/CTI and Internet portal Swiss Biotech. By the end of 2003 the Swiss biotech industry consisted of 227 companies in total, where 88 were biotech suppliers and 139 core biotech companies. In terms of number of core biotech companies, Switzerland is ranked #6 in Europe and #9 worldwide since 1998. About one-third of all Swiss core biotech companies have been founded before 1995. By the end of 2003, the industry employed more than 13,000 people. In 2002 and 2003 Switzerland ranked third in Europe regarding venture capital flown into the country. Regarding its company size the Swiss biotech industry can be split up into three main categories: the six public companies with globally active and well-known biotech leaders such as Serono, Actelion and Berna Biotech and about 20 medium-sized companies with 50 to 100 employees (many of those companies more or less ready for IPO). All remaining companies are still rather small with less than 50 employees. Geographically, the majority of Swiss biotech companies are located in one of the three hotbeds in the Arc LÃ©manique area or in the regions of Basel or Zurich. The Swiss industry is strong in pharmaceuticals and chemicals. Consequently 86 percent of the 139 Swiss core biotech companies are active in the field of red biotech (human & animal health) and only 8 percent in grey biotech (environmental & industry) and 6 percent in green biotech (agro & nutrition). Almost 50 percent of the Swiss core biotech companies are active in receptor biology/signaling, immunology or screening. Interestingly, the first two areas are those scientific fields where, according to the citation index, Switzerland has the top research position worldwide. This fact indicates that Swiss scientists have successfully founded their own biotech companies and are now transforming their scientific know-how into biotech business. Source: http://www.swissbiotechassociation.ch/ Blueprint for Enhancing Life Sciences in Iowa (USA) To promote and enhance the activities of life sciences in Iowa in the US, the Iowa Biotechnology Association has prepared a blueprint for "Enhancing the Development of Iowa's Life Science Industryâ€”an Industry Perspective". The Blueprint defines what the industry views as life sciences, why the life sciences should be important to Iowa, identifies many of the vital assets found in Iowa, briefly looks at growth opportunities and draws on industry focus group responses for issues and policies for the future. This document will help shape the key areas for the association in the coming three years and will offer public policymakers a concise summary of industry perspectives. Today, there are more than 200 companies, such as Garst Seed, Monsanto, Pioneer Hi-Bred International, and Wacker Biochem Corp., involved with some aspect of life sciences doing business from Iowa locations. Nationally, Iowa has the 15th largest concentration of biotechnology companies in the US, and is a hotbed of new investments. The New England Journal of Medicine ranks Iowa in the top five most productive states in terms of biomedical research publications. And in annual surveys of the best US hospitals, US News & World Report ranks the University of Iowa Hospitals and Clinics among the top 10 in the country in several specialty areas. The State of Iowa historically has been very supportive of long-term initiatives in the life sciences. State support was critical in the development of the Center for Biocatalysis & Bioprocessing (CBB) at the University of Iowa and the Office of Biotechnology and Plant Science Institute at Iowa State University. Over the last several years, the CBB has evolved into a model for successful university-industry partnerships, as evidenced by its relationships with firms such as EnzyMed and Quorum Sciences. At Iowa State, the Plant Science Institute has a goal to partner with private companies and individuals for a $100 million investment over the next 10 years. Source: http://www.iowabiotech.com/ MichBio launches BioConnections program MichBio, Michigan's life sciences' industry association has introduced bioconnections.org, a new web site that makes it easy for Michigan's life science industry employers and job seekers to find out and participate in the program. "MichBio launched the new web site so that life science companies can apply online to determine funding eligibility and then assist them in their job creation and hiring process," said Michael Witt, executive director, MichBio. BioConnections is Michigan's response to finding qualified candidates with specialized skills to fill positions in the life sciences industry. BioConnections is a collaborative program of industry partners including the STATPROBE Onsite, a full-service staffing firm, Search Masters International (SMI), a scientific and executive retained search firm, the Washtenaw Development Council, the lead economic development organization for the Ann Arbor / Ypsilanti area and BioSpace, a web resource for jobs, news and information for the life sciences market. The BioConnections program is funded by the Michigan Economic Development Corporation (MEDC) and is administered by MichBio, the state association for life sciences companies. The web site offers details on the five programs of BioConnections that offer subsidies to eligible Michigan life science companies: internship placements; general staff recruitment; executive search services; custom HR consulting; and a discounted job posting site. In addition to the new Web site, bioconnections.org, the program had been conducting several new promotions in March including: summer internships, BioSpace job postings, HR consultation and business help. Source: http://michbio.org/ New York State unveils Excell-NY Economic Development Program Senate majority leader, Joseph L Bruno, unveiled the Senate's new Excell-NY Economic Development Program and job creation plan in Albany. The Excell-NY program is the result of research and recommendations collected by the Senate's NextGen Task Force, chaired by Senator Dean Skelos (R-C, Rockville Centre). The NexGen Task Force worked closely with key industry leaders including New York Biotechnology Association (NYBA) and its members throughout the state, holding public hearings to identify and address the challenges the industry faces. An ad hoc plan was defined as a result of the hearings to turn new ideas and technologies into successful business ventures, resulting in increase of employment opportunities. The Excell-NY plan stems from the continuation of the Gen*NY*sis program and the Governor's Centers of Excellence initiatives. According to NYBA 2003 data, there are 101 biotech companies that call New York home, employing over 6,300 people. This is a 13 percent growth in the number of companies and a 17 percent growth in the number of employees over the past two years. These companies spent over $560 million dollars on research and development, had total expenditures upwards of $2billion dollars, and revenues of $1.6 billion dollars, a 33 percent increase in two years. The task force felt that for any state to lead in the biotech industry race, strong commitment and support of programs that drive cluster development must occur. New York State has already recognized the potential of the biotechnology industry, and has started to make investments in its future. NYBA wants to help focus that effort, and believes if those investments are made, New York can realize the goal of a world-class biotechnology industry within its borders. Some of its recommendations include: Target investments to areas with the greatest concentration of "biotech success factors", creating three clusters in New York State: downstate (Westchester/NYC/LI), western NY (Buffalo/Rochester), and capital (Albany region). Site new incubators in areas of high concentration of research institutions (downstate: NYC) Site science/tech parks near to incubators, and in regions where current industry strength is already present. (Downstate: Westchester & LI, western: Rochester, capital: Albany) Site manufacturing in areas of land and labor availability, and where there is a history of manufacturing. (Buffalo, Capital Region) "Excell-NY is a comprehensive plan that will serve as a catalyst for innovation and job growth," Senator Bruno said. "Our plan will promote venture capital investments in emerging companies, provide information and assistance related to technology transfer, private business development and employee training and include targeted tax reductions, Empire Zone reforms and other actions that will strengthen the economy. In addition, we are proposing other tax reduction initiatives to spur job creation, make New York more economically competitive and improve our quality of life." Source: http://www.nyba.org/ Montreal to host BIOMEDEX 2004Montreal to host BIOMEDEX 2004 For the third consecutive year, Montreal will be the meeting point of the key actors in Canada's life science industry during BIOMEDEX 2004. This event is the country's most important industry convention-exhibition and is being held on April 29 and 30 at the Hilton Montreal Bonaventure Hotel. Organized by BIOQuebec, in association with the Association de l'industrie des technologies de la santÃ© (AITS) and BIOTECanada, BIOMEDEX 2004 will be examining such themes as technological innovation, marketing, financing and research during its various workshops, conferences, business forums and industry exhibitions. "The third edition of BIOMEDEX represents an ideal opportunity to take the pulse of our growing industry, which continues to play a crucial role in the development of today's economy. Each year, we assemble numerous leaders from the biotechnology, medical technology and pharmaceutical industries, including business executives, researchers, financing specialists and research and development managers. They keep coming back, because the event constitutes a prolific environment for establishing strategic alliances and because participants can keep abreast of all the most recent developments, changes and upcoming trends", indicated Perry Niro, executive director, BIOQuebec. Source: http://www.biotech.ca/ US sets up new advisory board The US Department of Health and Human Service (HHS)'s secretary, Tommy G Thompson, announced that HHS will lead a government-wide effort to put in place improved biosecurity measures for classes of legitimate biological research that could be misused to threaten public health or national securityâ€”so-called "dual use" research. As a first step in this process, secretary Thompson announced the creation of the National Science Advisory Board for Biosecurity (NSABB). The new board will advise all federal departments and agencies that conduct or support life sciences research that could fall into the "dual use" category. The NSABB will be managed by the National Institutes of Health (NIH). "Our nation has been a world leader in life sciences research because of our emphasis on the importance of the free flow of scientific inquiry. Yet, sadly, the very same tools developed to better the health and condition of humankind can also be used for its destruction," secretary Thompson said. The NSABB will advise the secretary of HHS, the director of NIH, and the heads of all federal departments and agencies that conduct or support life sciences research. The board will advise on and recommend specific strategies for the efficient and effective oversight of federally conducted or supported potential dual-use biological research taking into consideration both national security concerns and the needs of the research community. NIH, FDA launch GeMCRIS The National Institutes of Health (NIH) Office of Biotechnology Activities (OBA) and the FDA Center for Biologics Evaluation and Research (CBER) have launched a new Genetic Modification Clinical Research Information System (GeMCRIS), a web-accessible database of human gene transfer trials that the two agencies developed collaboratively. GeMCRIS's adverse event reporting module provides a convenient, secure, and instantaneous means of conveying safety information to the NIH. In addition, GeMCRIS enables patients, research participants, scientists, sponsors, and the public at large to become better informed about human gene transfer research. Through drop-down menus and preformatted reports, individuals can easily navigate the GeMCRIS site to view information on particular characteristics of clinical gene transfer trials. Individuals interested in using GeMCRIS as an information resource about gene transfer trials should connect to the public web site at http://www.gemcris.od.nih.gov/. However investigators, study coordinators, and sponsors who wish to use GeMCRIS to report adverse events will need to access the secure web site by obtaining a User ID and password. Source: http://www4.od.nih.gov/ UK to increase R&D budget The United Kingdom's 2004 budget includes a commitment to increase R&D funding for its National Health Service (NHS) by $180.3 million by 2008. The UK said the increase would raise the combined annual budget for medical research and for R&D within the NHS to about $2.2 billion by 2007-08. In addition, the UK seeks to create a UK Clinical Research Collaboration (UKCRC), which will include the Medical Research Council, the Wellcome Trust and other medical charities, the NHS, industry and patients. The goal of the UKCRC will be to translate "scientific advances into patient care." Source: http://www.swedenbio.com/ Belgium cuts taxes The Belgian government has announced that it will be possible for research-based companies to benefit from a 50 percent income tax reduction for researchers. The researchers should be linked to research collaborations with universities and public research organizations. The new law will be implemented through 1 January 2005. The companies are expected to benefit by saving amounts for further investments or hiring new staff. The measure supports many research-driven companies and particularly those who are transferring technology form university research. Source: http://www.swedenbio.com/ Top 40 Locations for Biotechnology in the US 1 New York-Northern New Jersey-Long Island (NY- NJ-CT-PA CMSA) 2 Boston-Worcester-Lawrence (MA-NH-ME-CT CMSA) 3 San Francisco-Oakland-SanJose (CA CMSA) 4 San Diego (CA CMSA) 5 Los Angels-Riverside-Orange County (CA CMSA) 6 Philadelphia-Wilmington-Atlantic City (PA-NJ- DE-MD CMSA) 7 Raleigh-Durham-Chapel Hill (NC MSA) 8 Washington-Baltimore (DC-MD-VA-WV CMSA) 9 Chicago-Gary-Kenosha (IL-IN-WI CMSA) 10 Seattle-Tacoma-Bremerton (WA CMSA) 11 Houston-Galveston-Brazoria (TX CMSA) 12 Detroit-AnnArbor-Funt (MI CMSA) 13 Pittsburgh (PA MSA) 14 Atlanta (GA MSA) 15 Denver-Boulder-Greeley (CO CMSA) 16 Dallas-Fort Worth (TX CMSA) 17 St Louis (MO-IL MSA) 18 Minneapolis (IN MSA) 19 Indianapolis (IN MSA) 20 Cleveland-Akron (OH CMSA) 21 Nashville (TN MSA) 22 Columbus (OH MSA) 23 Miami-Fort Lauderdale (FL CMSA) 24 Greensboro-Winston-Salem-High Point (NC MSA) 24 Sacramento-Yolo (CA CMSA) 26 Rochester (NY MSA) 27 Tampa-St Petersburg-Clearwater (FL MSA) 28 Cincinnati-Hamilton (OH-KY-IN-CMSA) 29 San Antonio (TX MSA) 30 Portland-Salem (OR-WA CMSA) 31 Salt Lake City-Ogden (UT MSA) 32 Memphis (TN-AR-MS MSA) 33 Oklahoma city (OK MSA) 34 New Orleans (LA MSA 35 Hartford (CT MSA) 36 Milwaukee-Racine (WI CMSA) 37 Austin-San Marcos (TX MAS) 38 Providence-Fall River-Warwick (RI-MA MSA) 39 Kansas City (MO-KS MSA) 40 Buffalo-Niagara Falls (NY MSA) Source: www.facility.com ]]> <![CDATA[Sanofi-Aventis finally agreed]]> https://biospectrumindia.com/news/95/2381/sanofi-aventis-finally-agreed.html https://biospectrumindia.com/news/95/2381/sanofi-aventis-finally-agreed.html Tue, 11 May 2004 17:05:00 +0530 BioVenture Finally, the Aventis Supervisory Board recommended the substantially improved offer from Sanofi-SynthÃ©labo to create Sanofi-Aventis. This decision was based on a majority of 13 members, with two opposing votes by employee representatives and an abstention by the representative of Kuwait Petroleum Corporation, Seham Razzouqi. All members of the Aventis Supervisory Board were present or represented. According to Igor Landau, chairman of the Management Board, "We are pleased to have reached an agreement that recognizes the value of Aventis from a financial standpoint as well as the talent and expertise of our employees. By being equally represented in the management of Sanofi-Aventis, this agreement provides the necessary conditions for the success and development of the new group." Under the revised offer terms, Sanofi-SynthÃ©labo offers 0.8333 of a newly issued Sanofi-SynthÃ©labo ordinary share and a cash compensation of â‚¬20 for each Aventis ordinary share tendered (2003 dividend attached), and 1.6667 newly issued Sanofi-SynthÃ©labo ADSs and a cash compensation of â‚¬20 for each Aventis ADS. The offer consists of 71percent Sanofi-SynthÃ©labo shares and 29 percent cash. This improved offer would value one Aventis share at â‚¬68.93 based on the unaffected share price of Sanofi-SynthÃ©labo (one month-average) prior to the launch of their initial offer on 26 January 2004, which valued Aventis with â‚¬60.43 per share. The improved offer values Aventis in total at â‚¬55.3 billion ($64.2 billion) compared to â‚¬48.5 billion for the initial offer. As per the terms of the agreement, the combined company will operate and function under a name Sanofi-Aventis. The combined entity according to analysts is the third largest behind Pfizer and GlaxoSmithKline. Aventis is dedicated to treating and preventing disease by discovering and developing innovative prescription drugs and human vaccines. In 2003, Aventis generated sales of â‚¬16.79 billion, invested â‚¬2.86 billion in research and development and employed approximately 69,000 people in its core business. Shire to sell vaccines business Shire Pharmaceuticals Group PLC will sell its vaccines business to ID Biomedical Corp., a Canadian-based biotechnology company for an aggregate phased consideration of $120 million. As part of the transaction, Shire will provide IDB with a loan facility of up to $100 million, which can be drawn down over the next four years. This facility can be used by IDB to fund development of injectable flu and pipeline products within the vaccines business acquired from Shire. This loan will be repayable out of income generated by IDB on future non-Canadian injectable flu and other pipeline sales. The intention to exit the vaccines business was first announced by Shire in July 2003. This followed Shire's strategic review, which refocused the company on fewer projects at a later stage of development, as well as marketed products. The vaccines business is no longer core to the company's global strategy, and upon completion of this transaction Shire will be exclusively focused on therapeutic products meeting the needs of specialists doctors. Matthew Emmens, chief executive, Shire, commented "We are making good progress with our new strategy. The vaccines business has a good pipeline of products in early stage development and IDB is an ideal partner to take this business further, building on the success and promise that has already been created." The vaccines business, currently known as Shire Biologics, is active in research, development, manufacturing and commercialization of human vaccines. Its portfolio includes two marketed products: Fluviral for influenza and NeisVac-C* for meningitis C in Canada, as well as a pipeline of product candidates in streptococcus pneumonia, neisseria meningititidis, group B streptococcus and group A streptococcus. It employs over 400 people and has facilities in Quebec and Laval, Canada, and in Northborough, MA, USA. In 2003, the vaccines business generated revenues of $24.8 million and a net operating loss of $21.9 million. The divestiture of the vaccines business will assist in improving cash flows for the company moving forward. Arbios Systems acquires Circe Biomedical's assets Arbios Systems Inc., a biomedical device company with proprietary liver assist technologies useful in the diagnosis and treatment of acute liver failure, announced that it has acquired certain assets of Circe Biomedical. The acquired assets include, among others, Circe's intellectual property portfolio, rights to a bioartificial liver and related technologies, clinical and marketing data, a Phase III IND, and over 400 manufacturing and QA/QC standard operation protocols previously reviewed by the Food and Drug Administration. The assets were acquired in exchange for a $200,000 upfront payment and a $250,000 deferred payment due the earlier of 12 April 2006 or when the company has raised accumulated gross proceeds of $4 million from the issuance of debt or equity securities. Circe's HepatAssist is based on a BAL technology platform that was developed by the founders of Arbios, Drs AA Demetriou and J Rozga. The technology was licensed from Cedars-Sinai Medical Center in Los Angeles, CA, to WR Grace & Co. in 1994 who then eventually transferred the technology to Circe Biomedical Inc. HepatAssist is an extracorporeal (outside the body) liver failure therapy device, in which the function of porcine liver cells is supplemented by a detoxification column filled with charcoal particles. Arbios' LIVERAID is being developed to provide more liver support than the HepatAssist by combining much larger number of liver cells and expanded blood detoxification in a proprietary cartridge with unique fiber-in-fiber geometry. Antisoma acquires royalty rights Antisoma PLC, a biopharmaceutical company specializing in the development of novel anti-cancer drugs, announced the acquisition of certain royalty rights from Inverness Medical Switzerland GmbH, a division of the US-based company Inverness Medical Innovations Inc. These rights relate to any products based on the mouse and humanized variants of the antibody HMFG1, which form the basis of the drugs R1549 and R1550, respectively. Under the agreement, Antisoma is making an immediate cash payment of $300,000 to Inverness. Antisoma will make further payments totaling $1,500,000 subject to R1549 reaching key milestones on the path to commercialization. In return, Inverness has relinquished its right to receive any royalty payments from Antisoma for products based on HMFG1 antibodies. This will provide Antisoma with additional retained royalties comprising 2.66 percent of any future sales of R1549 and 1.5 percent of any future sales of R1550. Both R1549 and R1550 are being co-developed by Antisoma and Roche. Roche has worldwide marketing rights to these drugs under an agreement between the companies signed in November 2002. Parexel acquires 3C Parexel International Corp. acquires 3ClinicalResearch AG (3C), a clinical research organization with deep expertise in Phase I and Phase IIa Proof-Of-Concept studies. Parexel has been affiliated with 3C for several years, having established a minority ownership stake in the entity in June of 2000. It acquired the remaining outstanding shares of 3C through a cash purchase of approximately $12 million during March of 2004. Josef H von Rickenbach, chairman and CEO, Parexel, stated, "The acquisition of 3C adds further capacity to our clinical pharmacology business and to our operations in Berlin. Furthermore, 3C's Proof-Of-Concept capabilities help to round out our portfolio of services. Our enhanced clinical pharmacology network will provide us with access to a broader volunteer and patient population, and enable us to more efficiently recruit and screen patients for client studies. Additionally, the extensive capabilities of 3C in conducting cardiovascular, central nervous system, and infectious disease studies further deepen our expertise in these key therapeutic categories." Parexel is a leading biopharmaceutical outsourcing organization, providing a broad range of knowledge-based contract research, medical marketing and consulting services to the worldwide pharmaceutical, biotechnology and medical device industries. SeraCare Life Sciences to acquire Boston Biomedica's assets SeraCare Life Sciences Inc. signed an agreement with Boston Biomedica Inc to purchase substantially all of the assets of the latter's two divisionsâ€”BBI Diagnostics and BBI Biotech Research Laboratories. The acquisition is for $30 million in cash plus the assumption of certain liabilities. The purchase price is subject to adjustment based on the amount of net assets at the closing. SeraCare is a manufacturer and provider of biological materials and services essential for the manufacture of diagnostic tests, commercial bioproduction of therapeutic drugs, and additional research applications. Michael FCrowley Jr, president and CEO, SeraCare Life Sciences said, "We are excited about the acquisition of the assets of these two divisions of Boston Biomedica. Initially, we expect this move will expand our customer base, as BBI Diagnostics has access to markets and customers that have not previously been within SeraCare's reach. Additionally, we believe that the union of BBI Biotech's R&D expertise with SeraCare's focus on customer service and marketing will allow us to incorporate BBI's products into our existing product line and increase our market share." Sigma-Aldrich acquires Ultrafine Sigma-Aldrich Corp. has announced acquisition of Ultrafine. Ultrafine is located in Manchester, UK and is a leading supplier of contract chemistry services for all phases of drug development, with capabilities ranging from fundamental research to GMP manufacturing, including the ability to supply active ingredients for clinical trials. Ultrafine's life science catalogue also currently offers more than 130 products, which enable its customers to expedite drug discovery and development. Commenting on the acquisition, Frank Wicks, president, Sigma-Aldrich Fine Chemicals, said, "Ultrafine reinforces and enhances our Fine Chemicals capabilities and is an ideal complement to our existing cGMP process development and manufacturing facilities in the UK, USA and Switzerland. Combining Ultrafine's medicinal chemistry skills and ability to rapidly provide preclinical and early clinical phase GMP material with Sigma-Aldrich Fine Chemicals' capabilities in process development and scale up, we are now better positioned to meet the demands of the pharmaceutical industry for high quality products and services through all stages of development, enabling customers to get their new products to market more quickly." ]]> <![CDATA[Widening horizons in BioInformatics]]> https://biospectrumindia.com/news/95/2560/widening-horizons-in-bioinformatics.html https://biospectrumindia.com/news/95/2560/widening-horizons-in-bioinformatics.html Mon, 12 Apr 2004 17:26:00 +0530 Widening horizons in BioInformatics With genomics research making strides, the volume of life sciences related data is increasing at a very fast pace. Organizing, analyzing and further utilizing this knowledge, collectively called as bioinformatics, is still a nascent and largely unexplored field in India. Meeting the industry norms The Institute of Bioinformatics is a well known institute and a center of excellence in research in cutting edge areas of bioinformatics, genomics and proteomics. BioSpectrum approached Dr Akhilesh Pandey, chief scientific advisor, Institute of Bioinformatics for his views on necessary skill sets for students . Ideally, a student should have sound knowledge of molecular biology, a passion for life sciences and an inquisitive mind. Apart from this, he or she should possess: 1. Knowledge of UNIX/Linux the operating system used for many computational biology programs 2. A good grasp of the concept of relational databases, which are the heart of bioinformatics 3. Programming languages such as Perl or Python, which are popular in the field of bioinformatics. In the future, knowledge of object-oriented databases may be increasingly important 4. Expert knowledge of sequence-analysis programs like BLAST is critical. 5. Web skills are necessary, including the ability to write Hypertext Markup Language (HTML) With the global bioinformatics segment expected to grow to $6 billion by 2005 according to several studies, opportunities abound in this sector. The fact that in the next 10 years most new drug designs will be genomics-related and there being a global shortage of one million professionals in this field, this unique niche area is waiting to be explored. Though the opportunity exists, it should not be construed that bioinformatics is the next big thing. It is not and cannot be compared with the IT sector say industry observers. "There is a lot of data to be managed and mined. However, biotech companies over the last two years have been busy surviving and had not looked at solution providers for informatics solutions in a big way. Pharma companies, on the other hand, look for ready products to be bought and are generally averse to outsource custom projects. Availability of free software or software bundled with analytical equipment is another challenge facing the pure play bioinformatics companies," pointed Ajay Simha, director, SysArris Software Pvt Ltd, a Bangalore based company offering IT software solutions and services to the pharma and biotech segment since the past eight years. Vibhav Garg, functional consultant, Mascon Life Sciences, a New Delhi based company that develops bioinformatics software for pharma companies and research labs, feels that the current buzz about bioinformatics is partially justified. "There is an urgent need to understand the available data. But the hype created by unauthorized so-called training centers is absolutely unwarranted and many times creates confusion in the minds of new entrants," Garg informed. None deny that bioinformatics, the amalgamation of biology and information technology, requires a range of "interdisciplinary skills". "The requirement here is to be able to have a good blend of computer and life science scientists working together and delivering solutions, which are the best of both domains. This is so because it combines two domains with very different principles and ways of functioning," observed S Sowmyanarayan, manager, business development and alliances of Strand Genomics, Bangalore. Bioinformatics companies generally have well-defined teams with a clear business focus. For example, in Mascon, there are three groupsâ€”a functional team, which is the driving force, consists of domain experts. The development team is the supporting arm and comprises the software professionals. Then there is a business development team. Likewise, SysArris has domain experts who are thorough in genomics, cheminformatics and other areas. These experts understand the requirements of customers, analyze it and suggest the solution. The software team then converts the requirements to a software solution. Till last year, bioinformatics accounted for about 4 percent of the total size of the biotech industry, but it is expected to catch up fast. The total sales revenue (2002-03) generated by this segment was about Rs 75 crore and a major chunk of it (64 percent) was through projects for overseas companies. Today most of the companies in this segment are small to mid size, with employees ranging from 25 to 200 plus and the average man to women ratio is 2:1. The salary range depends on the experience and capabilities of the person and performers are recognized and well rewarded. "While the starting salaries could be anywhere from Rs 10,000 to Rs 20,000 per month depending on the experience of the candidate, it can go up very high as there is a review every six months," said Anuradha Acharya, CEO, Ocimum Biosolutions, Hyderabad. Others too feel the same. The salaries offered can start from Rs 1.8-2 lakh per annum and can reach as high as Rs 12-15 lakh per annum based on the experience and type of skills. This nascent field provides immense growth opportunities in terms of knowledge base, market exposure and career advancement. "We have identified several growth tracks for our employees. These could be either in pure software development, bioinformatics, management or sales and marketing. A person could start as a trainee, bioinformatician or software developer and could end up becoming part of the top management," added Anuradha. Selection process For entry and junior level candidates, companies conduct written tests and interviews, whereas at senior levels intake is generally through referrals and a round of discussions. "We generally look for people with at least one year relevant experience; if no suitable candidates are found, we take the most suitable candidate and train on-the-job," said Ajay Simha. Some of the companies do campus recruitments. Often, companies prefer to go to the IITs and RECs. Most companies have a very structured procedure for intake of candidates. Like Anuradha Acharya explained, "The procedure for manpower selection starts with management review meeting where the resource plan for manpower recruitment is prepared. After the resource plan is prepared, the next step is to find out the reliable resources to get the manpower. For instance registration with the jobsites, placing an advertisement in paper, approaching consultants and through employee referral program, which is called 'Introcentive'. The next step is scanning resumes for a specific requirement and short-listing them. Then the short listed candidates have to go through a screening test. After qualifying the screening test, an applicant has to undergo a minimum of three rounds of interview. Once the applicant is through with all the above rounds, he/she would be put to the top management for final interview. Once the top management is convinced, the next step would be issuance of an offer letter." Besides the basic qualification (a masters or higher degree in a branch of life science or computer science), prior experience or training in the industry or research organization is an added advantage concur most company heads. But the experience required would depend on the openings from time to time. As such, bioinformatics being a new field, it is very difficult to get people who have cross-functional expertise. Hence, the companies generally provide training before putting the candidate to work. Some like Ocimum Biosolutions offer a postgraduate diploma program in bioinformatics in association with University of Alabama at Huntsville. The duration of the course is six months. The students who join this program usually have expertise or a degree in either life sciences or computer science. The program nurtures them to become cross-trained. "This has worked out very well for Ocimum both in terms of recruitment and also keeping the development team up to date with the subject. All employees are also encouraged to participate in this program," elaborated Anuradha. Many bioinformatics companies have an arrangement for short-duration high-end specialized training for working professionals. They permit internship projects for students. According to YK Maheshwari, Sr VP, health care and life sciences, Kshema Technologies, Bangalore, "Hands-on training or experience is not a necessary prerequisite, but those with such experience are obviously preferred. Selection is easier for engineers or professionals, who have developed software, who understand the development SDLC (Life cycle processes) and know the requirement gathering process or candidates with knowledge on data warehousing, business intelligence, pharma workflow, lab management systems, FDA approval process, drug discovery life cycle". So is there a future? Maheshwari summed up: "There are multiple opportunities, in what goes under the wide banner of bioinformatics. Technical developments such as molecular genetics, proteomics and metabolomics provide the analytical base to support the advances in life sciences, but there is a demand for novel automated tools to reduce the time involved in the discovery life cycle. There is a shortage of individuals, though critical for the future, with the necessary multidisciplinary expertise for the development of genomic/analytics applications that demands a high level of knowledge/interpretation skill beyond that previously employed in the information technology sector." But at the same time the buzz about bioinformatics is not entirely justified since it undermines the requirement of core strengths such as fundamental biology, genetics, molecular biology, statistics, computer science and mathematics and places emphasis instead on a loose mix of all these fields. Rolly Dureha ]]> <![CDATA[Targeted research for developing world]]> https://biospectrumindia.com/news/95/5255/targeted-research-for-developing-world.html https://biospectrumindia.com/news/95/5255/targeted-research-for-developing-world.html Mon, 12 Apr 2004 17:23:00 +0530 Respite from the malarial scourge is in sight. The International Centre of Genetic Engineering and Biotechnology (ICGEB), New Delhi, has developed a vaccine for Malaria. The clinical trial results, so far, have been encouraging. Now the vaccine is all set to enter the human clinical trial stage. The Malaria Vaccine Initiative (MVI) launched by ICGEB, New Delhi, has been involved in understanding the functional roles of malaria parasite proteins and developing potential vaccine candidates. This much-applauded project is in the final stages now. In a couple of months the vaccine will enter the final phase of human clinical trials. The institute has signed an agreement with Hyderabad-based Bharat Biotech Ltd, which would manufacture the vaccine for human clinical trials later this year. Explaining about the malarial vaccine, Dr VS Chauhan, director ICGEB, New Delhi component, said, "The Indian malaria vaccine program ranks amongst the best in the world and had attracted funds for the production of vaccine grade material from the biotechnology industry in India, clearing the way for the first-ever Indian malaria vaccine trials. Basically, the researchers at ICGEB fine-tuned the candidate vaccine against infection from Plasmodium vivax, the most widespread form of malaria in India and then transferred the technology to Bharat Biotech. The challenges faced in developing the vaccine were mainly because of the parasite's complex life cycle, multiplicity of parasite strains, and the global drug resistance." "Need to add more values to our skill" Heading the International Centre for Genetic Engineering and Biotechnology, New Delhi component, Dr VS Chauhan believes that though we have enough skill and knowledge base to start off in biotechnology but we need to constantly improvise. How does India compare with other developing nations in the biotech arena? The term biotechnology is really catching up in India. But it is time to actually analyze our growth path. The question ahead of us is that are we taking the right direction. Biotech in India is like a newborn baby that requires proper attention. Unless and until we catch hold of the cutting edge technologies that can be delivered to the industry, we cannot reach the correct destination. Today in the Indian biotech industry, we have a limited numbers of big players. I think we require more efforts and time to grow and establish ourselves in the global biotech arena. What is the status of research on the Malaria vaccine initiative taken up by ICGEB? The Malaria Group at ICGEB has been involved in understanding the functional roles of malaria parasite proteins and developing potential vaccine candidate antigens. On the basis of the current promising results, the malaria vaccine is about to enter the final phase of trials. The vaccine is moving into the human clinical trials, after a few months. The marketing rights for Indian market of this malaria vaccine have given to Bharat Biotech ltd. What is the status of technology transfer at your center? It is a known fact that scientists are unfortunately not very good at negotiations for their own science. At ICGEB we are working to improve this situation. For example the Process Development Lab is our initiative to get closer to industry. Through this lab we try to provide a technical platform to bridge the gap between the academia and industry with the aim of making technology transfer easier for the industry. We are open for collaborations with the industry and tend to work on research areas which address the need of the society and the industry. How do you rate the potential of India's knowledge base? Everyone is quoting that the Indian knowledge base has a great potential for attracting international attention. But somehow I personally believe that though we have enough skill and knowledge base to start things, but to become leaders in biotechnology we need to add more values to our skill. Scientific community in India needs to get connected with the latest research tools and the new emerging trends. We need more innovative ideas to take shape into research. Another feather in the cap of ICGEB, New Delhi component is the recent development of a Dengue Detection Kit. This project was carried out by Gene Expression Group of the Centre in collaboration with Defense Research Development Organization (DRDO). The Center has already filed an application for an Indian patent on it. Since the technology development is almost in its final stages, it will be soon transferred to the industry. Emphasizing the importance of the kit, Dr Naveen Khanna, group leader, Recombinant Gene Expression group, ICGEB said, "Dengue virus infection has emerged as a significant global public health threat. The situation is particularly serious as there is neither an effective antiviral therapy for its treatment nor a vaccine for its prevention." Elaborating on the other focus areas of Recombinant Gene Expression Group, Khanna said, "This group is engaged in the design and development of laboratory-scale production strategies for several therapeutically useful recombinant proteins and the transfer of these technologies to the pharmaceutical industry. In the past, we have successfully developed laboratory-scale technology for the production of recombinant proteins such as human interferon a2b, human interferon g, human growth hormone and Hepatitis B surface antigen. Our Hepatitis B vaccine preparation has been found to be both safe and efficacious in limited clinical trials carried out at the Sanjay Gandhi Post Graduate Institute, Lucknow." Today it is important for any research center to not only generate knowledge but also secure it. Speaking on this aspect Dr Chauhan said, "ICGEB adopts a positive patenting and licensing policy. Through the establishment of new guidelines, the centre is in a position to foster an innovative approach for global industrial relations, enhancing the finalisation of joint ventures and other partner orientated approaches for the commercialisation of the results of research in biotechnology. Cooperation with other international agencies is promoted to harmonise and speed up projects of common interest." As of now, 45 agreements have been finalised with industrial partners located in member and non-member states for the transfer of know-how related to the production of important compounds, biophar-maceuticals and other biotechnology derived products. During 2002 the Centerentered into seven new agreements, one patent application has been licensed in India and negotiations are currently underway for the licensing of a second patent in Argentina. Two of the patent applications owned by the Center have been licensed to companies in the US. There are 20 patents filed by ICGEB from both the labs at Trieste, Italy and New Delhi, India. Out of this six patents are filed in India. And among these, the Indian patent for "Process for preparation of Recombinant Gamma Interferon" has already been granted. Faiz Askari ]]> <![CDATA[Sievers, a multipurpose analyzer from Skytech Systems]]> https://biospectrumindia.com/news/95/1106/sievers-a-multipurpose-analyzer-from-skytech-systems.html https://biospectrumindia.com/news/95/1106/sievers-a-multipurpose-analyzer-from-skytech-systems.html Mon, 12 Apr 2004 17:13:00 +0530 Sievers Sievers, a multipurpose analyzer from Skytech Systems It is often difficult to develop an accurate and specific method to quantify a particular component at the low residue levels associated with an easily rinsable cleaning agent. If a particular compound cannot be experimentally identified as a selective adsorber, then a single component analysis method is not applicable. Instead, a whole product analysis strategy such as Total Organic Carbon (TOC) analysis coupled with other analysis can be used to determine the level of organic cleaning agent residue present. Skytech Systems has a product called Sievers model 800 designed for multipurpose analysis, which helps in analyzing TOC in ultra-pure water, DI water, raw water, cleaning validation samples. It can be used for both offline and online analysis. It is based on the ASTM approved technology of UV-Persulfate oxidation and membrane-conductivity detection. This technology eliminates interferences in TOC readings that occur due to presence of chlorides, nitrates, sulfates and THM's even in small ppb levels. It has a wide dynamic range of 0.05 ppb to 50,000 ppb with single point calibration. This calibration is very stable for a period of one year. Sievers provide IQ/OQ/PQ validation packages along with other accessories like precleaned vials, precleaned swabs and swab-sampling protocols. For further details contact: skytech@bol.net.in Evaporative air conditioning system from Purafil In a hot environment where ambient heat control is difficult, cooling is accomplished by passing air that is cooler then the skin over the body. Evaporative coolers are suited for this purpose. This kind of cooling is commonly used to improve the environment for people, animals, plants and processes. Evaporative cooling can be energy efficient, environmentally benign and cost effective if the current technology and equipments are used. Purafil Engineers have come out with a novel evaporative air conditioning system. The cooling pads of this unit are made of cellulose-based paper engineered from cross-sectional specially treated flute media capable of absorbing and retaining water to provide the maximum cooling efficiency. The cellulose media is treated with stiffening and anti-rot resins and is cross-corrugated to maximize the mixing of air and water. This has applications in commercial and institutional buildings, foundries, poultry farms, animal and green houses, power plants, hotels, auditoriums, and other hot environments. "Purafil" undertakes turnkey jobs for design, fabrication, erection and commissioning of evaporative air-conditioning systems. For further details contact: purafil@vsnl.net MeasureTest Corp offers 3300 series of portable particle counters Countering the air borne particles is key factor in biotechnology and pharmaceutical industry to maintain the standard and quality of the products. MeasureTest Corporation, a Mumbai based manufacturer and exporter of airborne particle counter offers Met One's Model 3313 and Model 3315 airborne particle counters which deliver a 1.0 cfm sampling rate with either 0.3 micron sensitivity (3313) or 0.5 micron sensitivity (3315). Operating from either AC mains or batteries, the 3300 series can provide continuous monitoring of clean areas, storing up to 2000 readings in its memory buffer. The stored data can be reviewed on the front panel, printed or downloaded to a computer. The built-in printer is standard. All six channels are displayed simultaneously on the front panel display, plus optional environmental sensor data, such as relative humidity, temperature or air velocity. Alarms can be set for all measurements. The operator can review stored records by using the scrollable display. Both ISO 14644-1 and Federal Standard 209E calculation modes are included, allowing stored data to be analyzed according to either standard. The enclosure can be either aluminum for lightness (7 kg) or stainless steel for environmental and chemical compatibility. The Model 3313 and Model 3315 from Met One are full-featured 1.0 cfm airborne counters that offer one important differenceâ€”portability as a battery-operated instrument. For further details contact: sheesh@vsnl.com Bry-Air introduces ECOSCRUB Air and Gas Purification System The corrosion of delicate electronic components/electrical process controls results in production stoppages, increased production cost, higher maintenance budgets, lower productivity and sometimes, false signals and alarms. This corrosion is a result of, gaseous contaminates like hydrogen sulphide, sulphur dioxide, mercaptans, chlorine, ammonia, nitrogen oxides, hydrocarbons etc., generally present in the exhaust process air. The Bry-Air ECOSCRUB Air & Gas Purification System (AGP) for corrosion control of electronic/electrical process controls provides an ideal and cost effective solution to eliminate corrosion problems in industrial environments like pulp and paper mills, refineries and petrochemicals, steel and aluminum manufacturing plants, power generation plants, mining and metallurgy industries, chemical and cement plants, etc. ECOSCRUB is available in four different models ranging from 500 CFM (850 CMH) to 2000 CFM (3400 CMH), both as pressurization as well as re-circulation modes. All ECOSCRUB units are designed to operate and maintain corrosive gas levels at 1 ppb or less. For further details, contact: enquire@pahwa.com Washing station from Pharmalab As per GMP standards cleaning is a must in a validation process. Till today the washing was done manually and it was operator dependent. In biotechnology where hazardous products are handled, washing of container is more critical to prevent contamination of the environment and personnel. Now Pharmalab offers a close cabinet arrangement for washing containers, bins and vessels with different type of washing arrangement for washing it from inside and/or outside as required. Washing can be with air, with purified water or WFI water from inside and/or outside. If required Pharmalab is also equipped to provide a complete CIP cleaning system for internal wash. At the end of the cycle there is a provision for hot air drying with microbial retentive HEPA filter. (Heating arrangement can be electrically or steam heated through heat exchanger). For further details contact: Santej@pharmalab.com             ]]> <![CDATA[Need for a commercial DNA fingerprinting unit]]> https://biospectrumindia.com/news/95/1545/need-for-a-commercial-dna-fingerprinting-unit.html https://biospectrumindia.com/news/95/1545/need-for-a-commercial-dna-fingerprinting-unit.html Mon, 12 Apr 2004 17:13:00 +0530 Need for a commercial DNA fingerprinting unit Pushpa M Bhargava is one of India's most brilliant scientists. He founded and directed the Centre for Cellular and Molecular Biology (CCMB), Hyderabad. The number of times the DNA fingerprinting technique has been used is excruciatingly small when compared to the extent to which it could have been used mainly because there are no reliable and trustworthy commercial DNA fingerprinting laboratories in the private sector. When 3200 years ago, the legendry Solomon, King of the Hebrews, was petitioned by two women, both of whom claimed to be the mother of the same child, he decided the case by playing upon the genuine emotions of the true mother who would rather give the child to the other woman than have it cut into two pieces. Today, the wise Solomon would have asked to have the issue settled irrevocably by having the two women and the child DNA fingerprinted. Closer to our time, in 1909, Prince Ramendra Narayan Roy of Bhawal Raj, a princely estate in the eastern district of Dacca in the British Bengal, was suddenly declared dead in Darjeeling under mysterious circumstances. A couple of decades later, an unknown Sanyasi arrived in Dacca who claimed to be Ramendra Narayan Roy and was identified to be him by the people of the estate and members of his family except his wife. There was a hard-fought legal battle at several levels, with the case even going to the Privy Council in London. The judgment was in favor of the 'Bhawal Sanyasi'. Today, with the availability of the DNA fingerprinting technology in the country, the case would have been settled within a week and without much expense. In the 1940s, when I was a student of Lucknow University, the country was rocked by the disappearance of a young pretty maid Bilasia, apparently at the hands of one BB Singh, ICS. Sometime later, a few bones were unearthed from a site where a part of the dismembered body of the Bilasia was supposed to have been buried. The question that then became paramount in the eyes of both the law and the public was: did the bones belong to Bilasia? This would have been a non-question today. It would have been easily resolved by DNA fingerprinting the bones and Bilasia's parents. These are just three cases from history. Today, in our country alone, there could be easily a couple of hundred thousand cases of murder or disputed parentage, which could be settled irrevocably by using the technology of DNA fingerprinting. In fact, hundreds of such cases, if not thousands, have already been settled in this way by using the DNA fingerprinting technology pioneered in the country by Lalji Singh, currently Director of Centre for Cellular and Molecular Biology at Hyderabad, beginning 1988 â€“ i.e., three years after the technology was first developed and used by Alec Jeffreys in the UK. DNA fingerprinting has been, in the last few years, also used to a very limited extent by the Centre for DNA Fingerprinting and Diagnostics (CDFD) at Hyderabad (an offshoot of the CCMB) and by a few forensic laboratories in the country where the staff has been, virtually in all cases, trained in the CCMB under the overall supervision of Lalji Singh. Yet it is disappointing that the number of times this technique has been used is excruciatingly small when compared to the extent to which it could have been used. The reason for this extremely limited usage of one of the most powerful technologies of today has been that there are no reliable and trustworthy commercial DNA fingerprinting laboratories in the private sector. Before I argue the case for setting up an efficient and reliable DNA fingerprinting facility in the private sector on a commercial basis, in some detail, I would briefly describe the principle of DNA fingerprinting. That DNA is the genetic material is now common knowledge. The DNA of all the cells of the body of any individual is exactly the same in terms of the sequence of its building blocks. Similarly, DNA of identical twins is also exactly the same. There are regions in DNA, that is, structure in this linear sequence of its building blocks â€“ which vary from individual to individual to an extent that the exact sequence is not the same in any two individuals. The possibility of any two individuals having the same set of variations in a number of such selected regions of DNA, turns out to be, for all functional purposes, zero. Therefore, if we could identify these regions and find a probe that would locate one (a single locus probe) or more (a multi-locus probe) of such regions and visualize the regions thus located in a way that individual differences become manifest, we would obtain a kind of genetic fingerprint of the individual that would identify him irrevocably as it would be unique to the individual. The same would be true of animals and plants. Only identical twins or plants propagated vegetatively would have identical genetic fingerprints. In fact, the DNA fingerprints have lines or bands as in a bar code, 50 percent of the lines or bands coming from one parent and the other 50 percent from the other parent in the case of animals. Therefore, all that would have needed to be done in the case of Solomon was to determine which of the two women's DNA had 50 percent of the bands of the disputed child's DNA. In addition to establishing paternity or maternity or the identity of an individual (as was required in the case of Bilasia), or the genetic disorder(s) an individual may suffer from, the DNA fingerprinting technology can be used in many other ways mentioned below. (a) In solving rape cases - A few hair roots, or a small sample of blood, buccal smear, semen spots or skin tissue left behind by the criminal, is sufficient to obtain a DNA fingerprint which can be compared to that of the suspect for confirming the rape charge beyond any doubt. Vaginal swabs taken up to 20 hours after intercourse are particularly suited for identification of the rapist. (b) In solving murder cases (c) In identification of mutilated bodies and skeletal remnants (d) In establishing family relationship for immigration (e) In solving cases of allegations of "switched babies" (f) In establishing identity of missing children (g) In social security record identification (h) In solving ransom cases - In one case the suspected criminal was identified unequivocally by DNA fingerprinting the saliva he used to stick the stamp on the envelope containing the letter asking for the ransom! (i) For defense records - DNA profile of service personnel can be of immense help in establishing their identity during disasters such as a crash, or during war. DNA analysis of applicants at the time of recruitment may help in detection of a number of genetic diseases, which may incapacitate a person during critical hours of military operation. (j) Pedigree assurance in livestock breeding, and cell line authentication in researcher for industry (k) Agriculture, horticulture and veterinary practice - For example, for proper identification of seeds, identification of markers and the mapping of genes affecting economically important traits such as meat and milk production or disease resistance. The urgent need in the country today of a facility for identification of agricultural material, such as seeds or plants, alone would ensure profitability of a DNA fingerprinting project in the private sector, especially if the organization set up for DNA fingerprinting also carries out DNA-based diagnosis of inherited disorders, using essentially the same infrastructure as is required for DNA fingerprinting. In our estimate just by doing 50,000 agricultural samples, 10,000 cases of disputed parentage, 30,000 samples for establishing individual identity, and 30,000 samples for diagnosis of genetic diseases, one can have, at today's prices, a net profit of over 50 crore per year at the end of 10 years. The initial investment (including working capital) will be less than Rs 20 crore, and the project will start yielding revenue from the second year, with all the investment recovered by the end of four years. (We have a detailed project report available in support of what I have just said.) I hope very much that not before long an appropriate DNA fingerprinting facility, which would also engage in DNA-based diagnosis of inherited disorders will become available in the private sector. Pushpa M Bhargava   ]]> <![CDATA[Traditional Knowledge]]> https://biospectrumindia.com/news/95/2056/traditional-knowledge.html https://biospectrumindia.com/news/95/2056/traditional-knowledge.html Mon, 12 Apr 2004 17:09:00 +0530 Great gene robbery II In collaboration with developing country government, policy makers and the scientific community, WIPO is spearheading the Great Gene Robbery II. Devinder Sharma is a New Delhi-based food and trade policy analyst. Among his recent works include two books: GATT to WTO: Seeds of Despair and In the Famine Trap. The world's largest collection of plant germplasm, some 6,00,000 plant accessions, are in a safe custody under the control of the US Department of Agriculture. These genetic resources that lie stored at Fort Collins/Fort Knox in the United States are outside the purview of any international treaty. The countries from where these were collected have no control or say over these resources, nor do they get any benefit from providing these valuable resources. This is the outcome of the Great Gene Robbery part 1. Some 30 years later, the international community and that includes the Convention on Biological Diversity (CBD), the World Intellectual Property Rights Organisation (WIPO), the World Trade Organisation (WTO), the United Nations Environment Programme (UNEP), the Food and Agriculture Organisation of the United Nations (FAO) and several other organisations and donor agencies have joined hands to rob the developing world of the knowledge that comes attached with the huge biodiversity that existed in the tropical countries. In collaboration with developing country governments, policy makers and the scientific community, WIPO is spearheading the Great Gene Robbery II. Thirty years after the developing countries were made to believe that their economic interests were perfectly safe in collecting and conserving the massive plant germplasm that was getting lost, the world is at it again. And this time, it is the traditional knowledge that the international community is suddenly so concerned and worried about. This is in reality the green gold that lies unaccounted with the developing countries, including India. This knowledge is worth the entire gold that is stocked with the US treasury. In India, the Department of Science and Technology, Council for Scientific and Industrial Research (CSIR), the Indian Council for Agricultural Research (ICAR) and numerous agricultural universities, institutes and civil society organisations are engaged in documenting traditional knowledge. Like the earlier efforts to misappropriate genetic resources in the name of "mankind's heritage" and "security", this time the same language is being used to document the traditional knowledge that tells the exploiters of genetic wealth as to what uses the plant species can be put to. WIPO is already putting together a mechanism to draw intellectual property rights over the traditional knowledge that comes from the developing countries. I have often warned of the emotional rhetoric that has gone to sell the golden hardware (traditional knowledge is the real green gold) that lies in our backyards. It is often said that traditional knowledge, which has been passed on from generations to generations by local and tribal communities in the developing world, is getting lost. These would soon be lost to posterity and the humanity would be paying a heavy price for not conserving and keeping the same alive for future generations. The answer, therefore, is to document the traditional knowledge. After all, it too is mankind's heritage. It was in the mid-60s and early '70s that the same language and expression was used to seek monopoly control over the plant germplasm resources of the developing countries. At the height of the green revolution, with the land grant system borrowed from the United States well in place, we were told that plants were a mankind's heritage but were being lost in the process of development. Letting the plant germplasm disappear would be at the world's own peril. So what needs to be done is to collect whatever is available and keep these safely in gene banks. We did it. We made plant expeditions and picked up, classified and put the germplasm resources in the gene banks. It was then that we were told that the society would gain if, for instance, all the rice-growing countries were to keep their rice collections at an international centre, which in turn would act as a custodian of the invaluable genetic wealth. We did it again in good faith. India provided a copy of its rice collections for a common custody at the International Rice Research Institute, Manila, in the Philippines. The wheat collections were kept at the International Research Centre for Maize and Wheat (CIMMYT) at Mexico City. The other collections went to the 14 other international agricultural centres under the Consultative Group for International Agricultural Research (CGIAR). We were then told that these collections are not safe at Manila or Mexico city. After all, there is a distinct probability that a terrorist group can blow the gene banks with the result that these resources would be lost forever. So what do you do? You keep a copy of these collections in safe custody. And where is this safe custody? At Fort Knox and Fort Collins in the United States. We did it again and of course in good faith. The US has these plant genetic resources, has the finances for research and has the mastery over genetic engineering. But what is coming in the way is as to what to do with these genetic resources. After all, you cannot work out the chemical composition and find out the pharmaceutical properties of each and every plant stored at Fort Collins. The best way is to revert back to the countries, which originally had these plant resources. To find out from the local communities as to how and what uses they were putting these plants to. And that would give the companies the chemical route to decipher the knowledge, draw industrial uses, seek patents and market the product back to those countries where it has been traditionally been used for centuries. At a time when there exists so much of anger over biopiracy, sending a bio-prospecting team from a western university or a company would invite the wrath of the civil society in the developing world. The best way to legitimise biopiracy, therefore, is to encourage researchers, NGOs, and the public sector institutes to document the traditional knowledge. Give them a little research grant and you will have the civil society and cash-starved research institutes documenting the traditional knowledge virtually free for you. The UNDP, UNCTAD, the DFID, SIDA, CIDA, GTZ and almost all other donors are pumping in grants for documentation of the traditional knowledge. Except for the donors who continue to misguide the Indian researchers, no one wants to know what this documentation is for. No one wants to know why have we become suddenly so conscious of the fast eroding traditional knowledge. No one wants to work out the economic price of the traditional knowledge that is being given on an official platter. Moreover, who is using the documentation that is being done so speedily? The answer is that we all are facilitating the process of biopiracy. And we are doing it legally and with the backing of the international donors. Once again, such documentation is safely going into the hands of the companies who need them desperately. But unlike the genetic resources, it will not take 30 years for these companies to draw IPR over traditional knowledge. International effort has already begun on how to draw a sui generis system over traditional knowledge. It is a matter of few years. The documented traditional knowledge will then be out of the control of the communities, which nurtured them. The tragedy is that unlike biopiracy in the pastâ€”neem, turmeric and the likesâ€”the scientific community and the civil society is a willing partner this time. Devinder Sharma   ]]> <![CDATA['Clearly, Millipore is investing today in the biotech sector.']]> https://biospectrumindia.com/news/95/7773/clearly-millipore-is-investing-today-in-the-biotech-sector-.html https://biospectrumindia.com/news/95/7773/clearly-millipore-is-investing-today-in-the-biotech-sector-.html Mon, 12 Apr 2004 17:09:00 +0530 L-R : Jean Paul Mangeoolle , MS Mahadevan, Daniel Stamm & Julian Alonso Millipore is a 50-year old bioscience company that is focused on tools and products that help the development and production of new therapeutic drugs. Headquartered in Billerica, USA, it offers solutions to the life science research, biotechnology and pharmaceutical industries. Millipore employs 4,200 people in 10 manufacturing plants and has over 31 offices around the world. And it has been present in India for the last 15 years as a JV company. India is a very important destination for Millipore and its global executives have been visiting the country very regularly. In an exclusive interview with BioSpectrum, Jean Paul Mangeoolle, vice president, worldwide field operations, BioPharmaceutical Division, Millipore Corp.; Julian Alonso, director, Millipore India; Daniel Stamm, general manager, Europe, BioPharmaceutical Division; MS Mahadevan, general manager, BioPharmaceutical Division, Millipore India and share their thoughts on the plans for India as well as emerging technology trends. Biotech is a very important sector for Millipore. Why is it so and what is the overall focus of Millipore? The biopharma division in by far the biggest division. We are focused on three key market segments. The core pharmaceutical industry, which is NDDS and NCEs, the plasma and vaccines industry, which is kind of between the core pharma and biotech industry, using some of the biotech processes, although in a much smaller way. Then the biotech industry, which is recombinant vaccines, the monoclonal antibodies, etc. Clearly, Millipore is investing today in the biotech sector. This is because the biotech industry is a very separation intensive process. Does that hold good for India too? The transpose of our global strategy holds good for India too. There is not much difference. We do cover the core pharma accounts as this still represents a very large part of our business. But the developments and investments are made to respond to the demands of the biotech industry. Biotech is in a very early stage in India. In this business, if you do not play very early, then you cannot gain in the latter stages. So the latest developments you have seen in India are the application labs, the process development plans, the verification labs, etc. These have been set up in compliance with the global standards. You have three key business units? How are these focused? We have lab water, life science, and biopharma units. Lab water makes laboratory equipment for purification of water. Life science makes products for research in the labs and biopharma makes products, which are used in manufacturing, production and control of drug substances. Biopharma would easily be three-fourth of the total size. Millipore was $800 million in revenues in 2003. In Europe and the US you have a strong manufacturing base. What is the scene in Asia Pacific? There is not much manufacturing in Asia. We have some manufacturing in India. We are in a very early stage strategy of sourcing for products from India. The level of suppliers' service we can get is increasing and we are looking at procuring more products from India. But we do not have full-fledged manufacturing operations from India. What is your India strategy? The biopharmaceuticals business is focusing on core pharma applications, the process and quality control applications. We are focusing on plasma, vaccines, and the so called biotech applications (not as sophisticated as the real biotech like monoclonal antibodies, recombinant proteins). Where are our dollars coming from? Obviously from the core pharma as the biotech sector is just kicking off. We know that it coming. At the moment this is not generating business yet. Revenues by Geographic Area 2003 2002 % Growth Americas $336 $314 7% Europe $319 $260 22% Asia/Pacific $145 $130 12% Total $800 $704 14% The strategy in terms of investment is with respect to the biotech industry. We have a verification lab, application lab, process development lab; we are hiring people and several global executives visit India regularly to support the Indian business. All this has been in view to educate and build awareness. This is important, as classical pharma applications are not as scientific as biotech applications. One may not need the same level of science and support in the former. Biotech as a business is potentially lucrative. We continue to support the classical pharma. The revenues generated through this are invested into developing biotech resources. It is a long-term strategy. Honestly, 5-10 years from now, we will see the benefits of making investments into biotech. We are focusing only on our competency by not moving into providing customers with things that they should not buy from us. In a developing market like India, there is a tendency for a customer to come to Millipore and say do everything for us. There are some things we do well and some, which we don't. We want to focus on what we do well. We want our resources to be used to support separation technology and help the customer use the applications effectively. How do you position yourself? A product company or a solutions and support company? We are definitely a technology-solutions company. Today, it is given that the products have to be of very high quality. We are not the only player in the market. The only way to differentiate in the biotech segment is by adding value to the product. There is a need for that in the market place. The customer today has to be standards and regulatory complaint. We can help the customer in deciding a process. The process is very important. We also know how processes are transferred from one site. We help seamless transition. The customer is expecting more than the catalogs and prices. They are looking for advice. Which are the technologies that will bring you business tomorrow? Millipore technology is used for a wide range of applications, from protein sample preparation to vaccine sterilization to monoclonal antibody production. Recent new products include new versions of MultiScreen membrane-based multi-well plates for molecular biology applications, and Opticap cartridges for biotechnology drug manufacturing. Millipore lab water systems are essential to research and analytical laboratory work worldwide. If you see, we are working on the different steps of the process. You have an upstream part, where the media is prepared to grow bacteria, mammalian cells, etc. in the fermentor. Then you have the down stream part where you purify down to molecular level and final sterile filtration of the end product. One trend, we see in the market is disposable manufacturing. The trend now is to go for plastic products instead of using stainless steel installations, tubings, and containers. This includes filters and filter housings too. Another area is in quality control. We are looking at faster detection of contamination. Today, it takes two to three days to let the bacteria grow before we get the results. We are looking at methods that give that result much faster. This is called as rapid microbiology and that is the field we are in and you will see newer products. The third one is the more general one. We bring new membranes to the market place that outperform the actual products in terms of throughput, flow rate. This improves the economy of a process to make it shorten. There are other fields like virus removal. Millipore is looking at that step. Further, we are looking at mechanical retention of a membrane etc. Millipore has looked at acquisition or alliances to move fast into the market place. For example, in January Millipore and HyClone Laboratories announced the formation of a bioprocessing alliance. HyClone is a global leader in cell culture consumables and disposable bioprocess liquid containment products and a subsidiary of Fisher Scientific International Inc. The alliance will help combine the critical elements required for value-added disposable manufacturing solutions. Biopharmaceutical manufacturers will have one supplier contact for the design, development, and validation support of disposable manufacturing systems combining HyClone bioprocess containers with various Millipore disposable separation products. Ch. Srinivas Rao and Rolly Dureha Thermo Electron ships its 100th Finnigan LTQ to INCAPSThermo Electron ships its 100th Finnigan LTQ to INCAPS Thermo Electron Corporation, a supplier of high tech instruments to life science laboratories and industrial customers has shipped its 100th customer shipment of the Finnigan LTQ high performance linear ion trap mass spectrometer to Indiana Centers for Applied Protein Sciences (INCAPS). The system was one of five Finnigan LTQs purchased by the INCAPS, which is a recently established venture between Eli Lilly and Company and leading academic, industry and government organizations. "INCAPS' mission is to provide both academic and industry researchers of the Indiana community and beyond with the most advanced commercially available and prototype proteomics instrumentation to customers requiring high quality proteomic analysis," said Dr. James R. Ludwig, CEO of INCAPS. Quoting Dr Ludwig the official release adds: "INCAPS is very pleased to receive the 100th Finnigan LTQ instrument shipped by Thermo Electron. Its objectives are further advanced by the addition of this instrument. We expect the LTQ to become a workhorse for our biomarker discovery effort for many years to come. Thermo Electron has been a very committed and collaborative partner and we look forward to continue validating and implementing their very best technologies." Thermo Electron has set new standards of performance for proteomics research and metabolic studies with the introduction of the Finnigan LTQ at ASMS 2003. Incorporating novel and patented technologies, the Finnigan LTQ delivers exceptional protein sequence coverage with sub-femtomole full-scan LC/MS/MS sensitivity at breakthrough speed. The release adds that this instrument is recognized by leading research and government institutions and by major pharmaceutical and biotech companies worldwide for delivering unprecedented performance in the identification and mapping of post-translational modifications. It is also recognized for accelerating early discovery phase investigations, and in the analysis, detection, and quantification of the most minor components in complex biological matrices. Researchers have a powerful tool for characterizing disease states and mechanisms of action with the Finnigan LTQ FT, as well as for developing new diagnostic and therapeutic strategies. The customer shipment of the 100th Finnigan LTQ marks a key milestone in the adoption of new linear trap technology in the marketplace, and demonstrates Thermo's continued leadership in ion trap mass spectrometry. Danish supplier opens subsidiary in Mumbai Chr. Hansen, a Danish supplier of food ingredients with a strong foundation in biotechnology opened its new subsidiary in India. By opening an office in Mumbai it has made its presence in 30 countries worldwide. It is one among top suppliers of ingredients (cultures, enzymes, colors, savory and special ingredients) for the food industry. It develops ingredient solutions for the food, pharmaceutical, nutritional and agricultural industries in close cooperation with its customers and partners. Its venture in India will initially concentrate on vegetable rennet and bacteria cultures for cheese and yogurt, two areas in which the Danish company already is the world leader. Later this year natural colors derived, for example, from fruits and berries and flavors for soups and sauces, among other things, will also be added to the menu. "The six personnel who will initially staff the office in Mumbai will be responsible for sales, marketing and providing technical advice, while most of the actual sales work will be taken care of by a nationwide network of distributors," said Tansukhlal Jain, managing director in Mumbai. Hansen is already a partner in AKAY Flavor and Aromatics, situated in Cochin in southwest India. Prof Chandrashekhar receives Chemito Award of Excellence Prof. TK Chandrashekhar, Regional Research Laboratory, Trivandrum (formerly with IIT, Kanpur) received the Chemito Award 2003, for excellence in applied research in the field of analytical techniques. The award ceremony was held at Gujarat University, Ahmedabad and was presided by Prof. V Krishnan, former President, JNCASR. The ceremony was preceded by technical sessions on gas chromatography and chemical reactors. Constituted in 1998, in the memory of BD Toshniwal, the Chemito National Award of excellence are presented to recognize significant contribution in the areas of applied research carried out using an instrumental technique (preferably chromatography or spectroscopy)/applied research in the field of chemistry and life sciences. The award carries an endowment of Rs 20,000, a certificate and a citation. BD Toshniwal was a pioneer in analytical instrumentation in India and the founder of Chemito Instruments Pvt Ltd. The Chemito National award of excellence for 2001 was conferred to joint winners, Dr Lallan Mishra, professor of chemistry, Banaras Hindu University and Dr Shobhana K Menon, professor of chemistry, Gujarat University, Ahmedabad. ]]> <![CDATA[Genomics & alternatives to animal use 2004]]> https://biospectrumindia.com/news/95/2770/genomics-alternatives-to-animal-use-2004.html https://biospectrumindia.com/news/95/2770/genomics-alternatives-to-animal-use-2004.html Mon, 12 Apr 2004 16:59:00 +0530 This international conference is an initiative of the Netherlands Genomic Initiative. It will be held at Crowne Plaza, Maastrich, Netherlands on June 2-4 2004. In this work conference, leading experts from relevant research-areas will identify and evaluate the potential of genomics technologies and techniques to replace, reduce and refine the use of laboratory animals in biomedical research, to prioritize areas of particular interest and to draw up a strategy for further research, development, validation and implementation. For further details, contact: alternatives@genomics.nl Analytica 2004 The 19th Analytica is being held at the New Munich Trade Fair Centre, Munich, Germany from 11-14 May 2004. Analytica, which includes the Analytica Conference, is one of the leading European trades fair for analysis and the life sciences, high-tech laboratory automation and data and process management. Held every two years this international event is the meeting place for specialists from the areas of environmental, foodstuffs and industrial analysis, biochemistry, biotechnology, genetic engineering, molecular and cell biology. The event will be a central marketplace for marketable products and solutions in the fields of instrumental analysis, diagnostics, laboratory technology and biotechnology and bring together the scientists, industry and users. For further details, contact: www.analytica-world.com New York venture summit The 2004 New York venture summit will be held on 7-8 June 2004 Madison Square Garden at New York. This will be a premier venture capital conference for venture capitalists, angel investors, executives of early stage and emerging growth companies, incubators, investment bankers, successful entrepreneurs, premier service providers and industry leaders. Uniting venture capital and innovation, this investment conference will feature VC panel discussions, company presentations and interactive workshops. For further details, contact: info@vcsummit.com Anti-viral/microbial partnering & deal making GTCBIO is organizing the "Anti-Viral/Microbial Partnering & Deal Making Summit" on 17-18 May 2004 in Hilton Airport, Harbor Island, San Diego CA. The conference covers novel therapeutic modalities like prophylactic antibodies, multi-valent engineered "psuedo-bodies", naturally variant or engineered cytokines, small-or short-interfering RNA (siRNA), rationally designed vaccines along with specifically targeting business development and financial professionals in the infectious disease area. For further details, contact: raniah@gtcbio.com BIO 2004 BIO 2004, the annual BIO exhibition organized by the Biotechnology Industry Organization (BIO) will be held on 6-9 June 2004 in San Francisco, USA. This world-class event is the world's largest biotechnology convention in the world. It is expected to attract more than 20,000 top-notch industry leaders, scientists, policy makers, academicians, and members of the media from all areas of the life sciences industry. This four-day convention will include programs that are representative of all disciplines, technologies, and other opportunities related to the biotechnology industry. The event has a business forum, an international exhibition and session tracks on policy, business development, finance, science, food and agri biotech, industrial biotech, etc. For further details, contact: bio2004@bio.org Advances in protein science (APS) world summit IBC is organizing "Advances in protein science (APS)" summit on April 19-21 2004 at Boston Park Plaza, Boston, MA. This will probably be the first protein event to provide senior researchers and management an in-depth look at what has been accomplished to overcome the challenges of translating protein science into new drugs and diagnostics, as well as to provide a roadmap towards future development. This conference will feature expert keynotes who will provide a clear picture of the regulatory, pharmaceutical, academic and global initiatives for advancing protein science. For further details, contact: jprudhomme@ibcusa.com ]]> <![CDATA[Make BioPartnering a Mission]]> https://biospectrumindia.com/news/95/6317/make-biopartnering-a-mission.html https://biospectrumindia.com/news/95/6317/make-biopartnering-a-mission.html Mon, 12 Apr 2004 16:41:00 +0530 There is no doubt that strategic alliances and partnerships have become the cornerstone of R&D strategy in the global pharmaceutical industry. The apostle of genomic revolution, Dr William Haseltine, chairman and CEO of Human Genome Sciences along with other leading speakers like Dr Kiran Mazumdar-Shaw of Biocon and Dr Rashmi H Barbhaiya of Ranbaxy shared their experiences and relevance of partnerships at the Frost & Sullivan organized "Bio Partnerships Seminar 2004" in Delhi and Bangalore on the 17 and 19 March respectively. They pointed out that the pharma industry's two-decade old business model of bringing together complementary knowledge, capabilities and experience for solving major medical needs is still relevant. And more "Each pharma company has phase I and II compounds and they are desperate for products. And this is where the biotech companies come in." Dr William A Haseltine, founder and chief executive officer, Human Genome Sciences   so in today's scenario. We present some of the key messages that were delivered during the summit in Bangalore. The bioindustry is all about human health and welfare. Whatever happens, our highest mission should remain human health. For a very long time, the pharma industry has focused on the diseases of the rich but it should look at the world as a whole."This is one of the main  reasons why I am interested in policyâ€”to improve human health. Correct policy will have integrated approach to improve health. Though we have not reached there but I have an inkling of what is going to happen," said Dr Haseltine. BioPartnering: What it looks like? BioPartnering is the partnership between the biotech and pharma companies. Why is biopartnering such a hot topic? There are several reasons. The pharma productivity has gone down over the past 15 years. There has been a 10-fold drop in NCEs in the big pharma firms. This problem is being addressed through structural reforms in big pharma companies but more money is not the answer. Although the industry has been the supplier of new technology but combinatorial chemistry took away the intuition, which had worked and this problem has been further compounded by genomics. Besides, there could be external reasons for the drop in productivity: â€¢ FDA norms are getting tougher â€¢ It could be an inevitable consequence of success â€¢ Structural problems â€¢ Problems of pharmacological combinations The end result is that we are going to see the pharma multiplies shrink. Each company has phase I and II compounds and they are desperate for products. And this is where the biotech companies come in. On the productivity front the biotech companies are 10 times productive. Their R&D budget is a tenth of the overall budget and 60 percent of their compounds target the niche markets. Second, the biotech companies also want to make blockbusters. So there is a natural partnership between the pharma and biotech companies. Though it is not an easy partnership but is inevitable and should happen after the proof of concept stage. Where does India come in? The biotech world is a resource-limited world, where to find new compounds, the companies will do anything to reduce costs. This has led to outsourcing of manufacturing, clinical trials, etc. to reduce costs while maintaining quality. India is an attractive destination for outsourcing because of the TRUST that the western countries have in it. This should be stressed upon and preserved. The reason for this underlying trust could be due to India's preexisting integration with the western world, which will serve it well. Also India has a system of governance and laws and a fair legal system. As such the Indian market is small and is not going to build a huge pharma or biotech internal market. Indian biopharma should be looking at the global market as India is uniquely situated between the developed and developing world. Today India has evolved as a raw material supplier for products but this is under competitive threat from both internal quarters and other countries like China. This is a race to the bottom. India can move up the value chain by competing on the manufacturing costs/processes, on the quality process and ultimately capture the proprietary product. India can partner early with companies, take the products through clinical trials and develop them. In this way working through collaborations India can bring a product to the proprietary stage and take the product to the market, thus owning it in part and benefiting from it. This is one way by which India can move up from the bottom of the value chain, from being a supplier to the top of the chain. But there are issues of ban on phase I clinical trials of outside drugs and pharma companies face problems in getting animals for testing. Both of these issues should be solved politically. Also for clinical trials, hospitals records need to be automated and the general infrastructure needs to be improved. Future areas of focus â€¦ Stem Cell Biology/Regenerative medicine: It has a great future in India due to its traditional skills in biology and the ethical problems being raised in the US on this subject. But India needs to sort out the animal testing issues, before entering this field. Nanobiotechnology: India has the advantage of a strong education system (in material and biological sciences) and IT expertise, which it can leverage to develop nanotechnology. "The partnering model is going to win the day for India." Kiran Mazumdar-Shaw, chairman and managing director, Biocon, and president, ABLE Kiran Mazumdar-Shaw, chairman and managing director, Biocon, and president, ABLE â€¢ The partnering model is going to win the day for India. The whole biopartnering process should shift to the more basic level of academia-industry interaction. This is necessary to create the required human resources. â€¢ India's strong fermentation and purification skills are being leveraged to become a globally competitive bioprocessing platform. India has shown its prowess in clinical capability, process development skills and manufacturing skills. â€¢ The opportunities exist in forward integration of drug discovery programs, "Proof of Concept" development for drug discovery programs, clinical development of new products and technologies, process development and scale up of manufacturing technologies. â€¢ Outsourcing is not all about the cost advantage but the quality of deliverables is also important. Further the speed of delivery and mutual trust and adherence to intellectual property norms is crucial. At this stage it is all about self-regulation, as we do not have patent lawyers, officers, etc. "India can become a TUG BOAT." Dr Rashmi H Barbhaiya, president, Research & Development, Ranbaxy Dr Rashmi H Barbhaiya, president, Research & Development, Ranbaxy â€¢ The opportunities for strategic alliances lie in NDD, preclinical and pharma development; IT applications; clinical development; herbal heritage; generics; and contract research. â€¢ Companies are looking at India because the cumulative success rate for a program is 1.5 percent. There has been a war on patents and investigators and India can play a very important role in the drug delivery, discovery, and development process. â€¢ Alliances working on shared goals will be desirable. The opportunities are in lead identification and optimization, biological screening, etc. â€¢ India can become a tugboat. It has strong data management abilities, strong base of CROs, and a pool of trained doctors and nurses.   Rolly Dureha & Ch. Srinivas Rao             ]]> <![CDATA["We are contemplating to do not only biogenerics but also new molecules."]]> https://biospectrumindia.com/news/95/3062/we-are-contemplating-to-do-not-only-biogenerics-but-also-new-molecules-.html https://biospectrumindia.com/news/95/3062/we-are-contemplating-to-do-not-only-biogenerics-but-also-new-molecules-.html Mon, 12 Apr 2004 16:32:00 +0530 When you are an entrepreneur venturing in to a new field, problems and controversies become your middle name. And so is the case with Varaprasad Reddy, MD, Shantha Biotechnics Pvt Ltd. With a vision to provide cost effective healthcare products to the masses, he established Shantha Biotechnics in 1993. Although an electrical engineer, he triumphed against the initial skepticism, funding problems and regulatory issues to launch India's first recombinant hepatitis B vaccine, Shanvac-B, in 1997. And since then, there was no looking back. In the news recently, on Shantha's latest launch, Shankinase (recombinant Streptokinase), being declared "illegal" by the GEAC, Reddy has no reason to worry as all the facts and figures speak for themselves. Talking to BioSpectrum, he recounts his initial trials and triumphs and traces the path of success for the Indian pharma biotech industry. How did you set up the company? What were the challenges then and how did you overcome them? In the year 1992, not many in India knew about Hepatitis B and its impact on human health. In fact, most of the medical fraternity also was not aware of this dreaded disease. At that time, only three companies globally were producing this vaccine, which was very costly to import and use. I came to know about this in one of the international seminars, which I attended by chance. There, the impression was that India and other neighboring countries only look towards subsidized vaccines and are not able to include Hepatitis B in their national immunization schedule. We were looked down upon as a country by the western society for not being able to take any initiatives either for developing the vaccine or for importing it. I found this very disturbing and insulting. When I ventured to do something about it and approached a western company for technology, further insult occurred. The company spokesperson felt that neither India has the capacity to pay the high technology fee nor the scientists have the ability to absorb the technology. It was then that I took up the challenge, knowing fully well that India has a vast pool of talent. I initiated the project as an R&D exercise to start with, at Osmania University, under the industry-university interaction program in 1993. Subsequently, we took shelter at the Centre for Cellular and Molecular Biology (CCMB), Hyderabad until such time we developed our own R&D facility. Many banks and financial institutions were skeptical about this project and they refused to fund because of two main reasons. The first being that the biotechnology segment was very nascent at that time and this particular Hepatitis B vaccine mortality data was not very encouraging with a meager 80,000 numbers per annum. In their perception, this was too small a number and no project can be viable with the sale of such numbers. The second reason was my background of electronic engineering, which they felt is not appropriate for the life sciences business. Venture capital funding had also not matured enough in the country by then. Luckily and by providence, Foreign Affairs Minister of Sultanate of Oman got in touch with me and participated in the equity to the extent of 50 percent and also arranged long term loan from Oman International Bank at a very subsidized rate of interest. Subsequently, ICICI came forward to give a loan for technology development. And when the R&D results were viable for commercialization of the product, the newly established Technology Development Board (TDB), under Ministry of Science & Technology came forward to fund, which has given the requisite impetus to the project. What is the company presently focusing on? Shantha's main focus is on new drug discovery using indigenous talent. The company is extending its manufacturing facility to facilitate manufacture of its various products coming out of R&D phase. Shantha's new drug discovery program involves work on monoclonal antibodies against non-small-cell lung carcinoma. Shantha's first indigenous development of recombinant Hepatitis B vaccine enabled India to join the select club of five countries to have the know-how to produce Hepatitis B vaccine. What is the next level of progression for Shantha Biotech? We are contemplating to do not only biogenerics but also new molecules. The main thrust is to go for monoclonal antibodies for various types of cancer. Per se, we are going to limit ourselves to health care products using biotechnology and we are not diversifying in any other area. There are three more products, which are going to be launched in coming four-five months time such as EPO, G-CSF, and combination vaccine of DPT+ Hepatitis B and Typhoid. Our main plans to bring more and more life saving drugs from our in-house R&D and also to provide contract research and contract manufacturing services. We are also looking for collaborative arrangement for co-development of any new drug/molecule. What has been the total investment in the company to date and how have you raised the funds? Our investment in the company is around Rs 125 crore. Shantha had raised the funds by equity through private placement and loans from banks and institutions. What is the positioning of Shantha Biotech and what are the current research activities? Shantha is a pioneer biotech company in the private sector and is the first biotechnology company to develop, produce and market the first recombinant product in India. Shantha's successful development of recombinant products has created a technology platform and this has motivated the scientists, given them enough confidence to try out indigenous development and production of other life saving drugs in the country without having to depend on imports. Many existing big pharma companies and new generation biotech companies have got motivated by the success story of Shantha's innovative R&D efforts in producing country's first Hepatitis B vaccine and country's first interferon alpha ('Shanferon'). Other products from Shantha under different stages of development and regulatory clearances include: EPO, GM-CSF, G-CSF, tPA, insulin, human growth hormone, combination vaccine of DPT + Hepatitis-B, typhoid vaccine, and monoclonal antibodies What has been your marketing strategy and how successful have you been? How has been the market acceptance/response to the recombinant products? Shantha is directly marketing its products all over India through its field force. We also started supplying to various countries directly and also through UNICEF agencies after SHANVAC-B got WHO-Geneva pre-qualification. Shanvac-B and Shanferon are widely accepted by the medical fraternity and the response was overwhelming from the public. Indian Medical Association, NGOs, Rotary Clubs, etc have come forward to conduct mass vaccinations. Shankinase has not yet reached the market. Since the launch of the indigenous recombinant drugs, what has been the effect on the domestic market and exports market? Shantha's entry into market with its Hepatitis B vaccine (SHANVAC-B) brought down the prices of imported vaccine from Rs 780 to Rs 50 in 1997 and to Rs 25 in 2003 and similar has been the case with our second product Shanferon (Interferon Alpha-b) also. How many manufacturing plants do you have now and how do you plan to gear them to address new products? We have a facility at Medchal, a suburb of Hyderabad city, to manufacture our products Shanvac-B (Hepatitis B vaccine), Shanferon (Interferon Alpha-2b) and also Shankinase (Streptokinase drug). We have invested about Rs 50 crore on manufacturing facilities. We have already taken up to build a new facility in the same premises (Medchal) to manufacture bacterial vaccines, for which we are expected to spend about Rs 60 crore. Strategic Alliances are important in any venture. How do you view this and how have you applied this at Shantha Biotech? So far, we have not gone for strategic alliances, but we have joint ventures. Shantha Marine Biotechnologies Pvt Ltd, Chennai, a joint venture between ABL Technologies and Shantha Biotech, to focus on marine biotechnology products. Beta-carotene is already in the market. (Editor: This JV has since been discontinued) Shantha West Inc. San Diego (USA), a joint venture between East West Laboratories, USA, and Shantha Biotech is involved in the development of novel therapeutic monoclonal antibodies for the treatment of different types of cancer. Exports of Bioproducts still have to pick up. What do you feel is the stumbling block and what should be done to address the issue? There are a lot of regulatory issues involved in exporting Bioproducts to developed/developing countries, which need to be addressed. We cannot enter each and every country just like that because of the patent and regulatory issues. Most of the developing countries are not ready with full-fledged regulatory systems and testing facilities resulting in enormous delays in getting the product registered. The Government of India should come forward to help its industry through our embassies in promoting the local industry in respective countries. This way, the products will get registered a little faster and the exports can pick up. Recounting your experience, what is your message for the biotech industry, the policy makers and industry? A separate Department of Biotechnology was set up by the Government of India in 1986 to give a boost to the development of biotechnology in the country. This was a laudable step. The Government has also initiated a $20 million genome initiative to facilitate advances in pharmacogenomics and new drug discovery. The call is to make India a destination for cost-effective solutions for global biotech issues. The biotech industry in India is poised to emerge as a significant player in the global biotech map. The following factors are fuelling its growth: â€¢ Low cost of innovation (R&D costs are one-seventh to one-tenth of that in developed markets). â€¢ Availability of a large pool of scientists. â€¢ Low cost manufacturing base â€¢ Established pharmaceutical industry, which is a platform for the sunrise biotech industry. â€¢ Financial support by the Government â€¢ Large diversity in the genetic make-up of the population. However there is a dire need for streamlining the processesâ€”regulatory and funding. The infrastructure too needs to be strengthened. All this calls for a comprehensive National Biotechnology Policy. Should the Biotech industry play a role in creating mass awareness on the diseases and the benefits of biotech products collectively? If so what would you outline as the three-four important measures? Biotech industry need not play a role in creating mass awareness for each and every product they come out with, but they should do it, when they bring out any novel product like Hepatitis B vaccine. When we launched Hepatitis B vaccine in 1997, most of the Indian populace was not aware what Hepatitis B disease was. It was we who had to create mass awareness by conducting mass vaccination camps, conducting awareness camps through media. In fact, the Government should come forward to take up the necessary steps to create awareness among the public by way of warning advertisements like what it is doing in the case of AIDS control. It should also take up the eradication of diseases like Hepatitis B through the national immunization program. N Suresh & Ch. Srinivas Rao       ]]> <![CDATA[R&D: Way of Life at Panacea]]> https://biospectrumindia.com/news/95/2684/rd-way-of-life-at-panacea.html https://biospectrumindia.com/news/95/2684/rd-way-of-life-at-panacea.html Mon, 12 Apr 2004 16:20:00 +0530 Panacea Biotec, a BioSpectrum Top 20 company, has had an exciting phase in the past year. The company made significant strides not just on the numbers front but also in research. For the quarter ended December 2003, its income grew to Rs 103.89 crore. More importantly, the company has made significant inroads into the New Drug Delivery System arena. It filed a worldwide patent for new NDDS for an anti-TB combination drug, recently. Besides filing the PCT application (under the Paris Convention) for a worldwide product patent, the company has simultaneously filed its application with Drug Controller General of India for registration in India for its new NDDS drug. Panacea Biotec's anti-TBNDDS drug is code named "Mykit". What is important is that its discovery is claimed to give 25 percent higher bioavailability than the existing anti-TB drugs. Its new NDDS drug uses a combination of four anti-TB drugsâ€”Rifampicin, INH, Ethambutol and Pyrizinamide. According to Joint Managing Director of the company, Rajesh Jain, Panacea has decided to take the NDDS-route for developing new products as a long-term strategy for growth. He further informed that besides Mykit, the company has some other NDDS-based products in the pipeline. Panacea Biotec is also in talks with some of the international laboratories for funding new NDDS products in diabetes and asthma segments. A few years ago, the company envisioned long-term strategies to venture into new opportunities available in the horizon, namely, the health and disease management areas. With a special focus on biotechnology, Panacea Biotec has been making concerted efforts to improve the repertoire of its vaccines. A host of new vaccines, employing genetic engineering and recombinant technology, is being developed. The Hepatitis B vaccine- Enivac HB is being manufactured in collaboration with CIGB (Center for Genetic Engineering and Biotechnology), Havana, Cubaâ€”a world leader in biotechnology. Amongst the forthcoming vaccines is anti-anthrax vaccine. Its vaccine and formulation plants are approved under WHO-GMP certification. Jain elaborated, "We have already signed an agreement with Biotech Consortium of India Limited (BCIL) to manufacture and market the anti-anthrax vaccine developed by Jawaharlal Nehru University. We plan to supply Anter (anti-anthrax vaccine) to the armed forces, paramilitary forces and establishments under the health ministry." The company has more than 2,000 employees on its rolls. Out of this, around 1,000 are field sales personnel who promote the products of its five Strategic Business Units (SBUs)â€”Pain Care, Primary Care, Diacar, Germ Care and Critical Care to the medical profession. Besides pain management, diabetic management and vaccines, the company has significant presence in other therapeutic areas like renal transplantation, osteoporosis, antibacterial therapy, tuberculosis, peptic ulcers, cardiac emergencies, migraine, erectile dysfunction and dietary supplements. The company has worldwide patents for many of its products. This is just the beginning of the things to come. Faiz Askari "R&D has always been acore area of our interest." Rajesh Jain, joint managing director, Panacea Biotec shares his views on the companies R&D efforts and future strategic direction for the company and the northern region. Panacea Biotec is believed to have stepped up its R&D initiatives? What has been the progress? R&D has always been a core area of our interest. At Panacea we intend to expand our scientific strength by delivering newer products to the industry. In other words, "research will be a way of life at Panacea". Pursuing its mission, "In Support of Life", the company has been progressing towards development of products and technologies that improve quality of life. From the company's R&D headquarters in New Delhi, to a major research campus in Lalru, near Chandigarh, Panacea Biotec works tirelessly to find new cures and drug delivery systems. The research conducted at our labs has led to successful filing and grant of product patents worldwide, in various categories. Our ultra modern 20,000 sq.ft R&D center in North India is equipped with high tech facilities and is supported by 60 scientists with specializations at par with the best laboratories in the world. Today, we are taking on some of the world's most intractable diseases, including polio, Hepatitis B, osteoporosis and diabetes. The results of our focused and intensive research programs are apparent in developing several outstanding medicines that can eradicate deadly and debilitating diseases. In the past several years, the drug delivery research group has developed technologies and filed for grant of several patents. Some of these research outcomes have already been transferred to the industry and commercialized. The group is engaged in the development of different technologies like transdermal drug delivery, controlled release systems, biorhythm based delivery systems, microemulsions, targeted vesicular systems like liposomes and niosomes, mucoadhesive nanoparticles, taste masked fast dissolving formulations, osmotically controlled delivery systems and gastro retentive systems to improve bioavailability. What does the drug delivery research focus on? The drug delivery research at Panacea R&D involves detailed study at molecular level and of mechanistic approaches for drug absorption, distribution and elimination. This is a cross-functional R&D where drug delivery research is supported by departments like molecular biology, pharmacology, toxicology, advanced organic chemistry, advanced physical chemistry, and advanced analytical research and bio-analytical research. Products developed and incorporating the formulation technologies outlined above are subjected to stability as per ICH guidelines. For preparation of clinical samples, a high tech pilot plant facility, equipped with latest machinery and conforming to GMP requirements is also available to the drug delivery research group. Which are your flagship products? We have three strategic business units. These are the vaccines, biopharmaceuticals, and pharma units. Each of these segments is coming out with a good range of products. Nemolate, Glizate, Enivac-HB and Ecovac are some of the products that are all doing well in the market. Panacea has announced ThankGod Piles management kit. What has been your experience in bringing out the kit? ThankGod took 10 years of extensive R&D. After conducting all toxico studies, clinical trials etc., the product is of international standard. It is a worldwide-patented product of Panacea Biotec. The ThankGod Piles Management Kit has been specially designed for integrated management of piles. Our vision was to provide a comprehensive solution to the first and second degree piles patients. The ThankGod Piles Management System consists of ThankGod Relief Capsules, ThankGod Anytime Cream, ThankGod Ispaghula Husk and ThankGod Pain and Itch Relief Cream. We are the only providers of such a 100 percent natural, worldwide-patented product, with successful clinical trials done in India. We collaborated with IHBT for developing the agronomy and clinical trials were conducted at Lok Nayak Jay Prakash hospital (LNJP), New Delhi. Is it a commonly available product and how much does the kit cost? The ThankGod Piles Management System Kit comes in a value pack along with a free Piles Patient Information Booklet and a free Internet Consultation Coupon worth Rs 250, which entitles the consumer to a free online consultation with a doctor for any specific queries. The ThankGod Kit has been designed for systematic and consistent treatment of piles, to be used in combination for 14 days. Shouldn't the industry vie for strong industry-academic partnership? It is always good for research, if any industry collaborates with any research lab at the early phase of a research work. I think industry is the component, which needs to point out the opportunity and share their ideas and opinions to the research community that will be good for science. At Panacea we are open for such kind of collaborations. It is frequently stated that public-private sector partnership is not an easy job, in terms of flawless productivity. What has been your experience? Working with the government is a constant affair. Now the biotech industry in India is at very nascent stage. We need to take very effective and aggressive efforts to boost the industry. We need to evaluate our strengths and weaknesses so that we can improve in building good infrastructure and a platform for the biotech industry in India. And as we grow, we would understand the challenges ahead of us. Then we could work as a team to deliver good results. What are the demands and needs of the industry? Exemption in excise is rigorously expected by the industry. We strongly hope that soon biotech will be considered in a more serious manner. The tone of interim budget is also sounding good for the R&D-active industry. Hope it will take good shape in future. Regulatory environment in India needs to be rechecked. Lack of venture capital funding is also an issue in this segment. We need to focus in that direction as well. And as an important need of biotech industry, the government should have representatives of the biotech industry as well. Faiz Askari ]]> <![CDATA[Technoglobalism: The Indian Opportunity & Challenge]]> https://biospectrumindia.com/news/95/2814/technoglobalism-the-indian-opportunity-challenge.html https://biospectrumindia.com/news/95/2814/technoglobalism-the-indian-opportunity-challenge.html Mon, 12 Apr 2004 16:16:00 +0530 Technoglobalism Technoglobalism: The Indian Opportunity & Challenge The term "Techno-globalism" means a strong interaction between the internationalisation of technology and the globalisation of the economy. Technoglobalism has created a widening of cross-border interdependence between individual technology based firms as well as economic sectors. Techno-globalism provides both challenges and opportunities for India. In recent years, multi-sourcing of innovations has gained enormous prominence. There is an increasing pressure on shortening international market penetration times for new products, on shortening R&D times and on decreasing the market life times for new products. Innovations are beginning to have multiple geographical and organisational sources of technology with increasingly differentiated and innovation specific patterns of diffusion. R&D in high-technology industries such as biotechnology, microelectronics, pharmaceuticals, information technology and new materials has become highly science based. The costs of doing R&D are also increasing phenomenally. The high technology goods have doubled their share of world merchandise in the last 20 years while at the same time dropping the share of primary products by half. More than half of the GDP in major OECD countries is attributed to the production and distribution of knowledge. There has been a progressive weakening of the strategic position of corporate central laboratories within large firms. The firms around the world are becoming very selective with internal developments focused on critical products and processes. They complement their internal efforts with external technology acquisition on a global basis. Global networks Creation of seamless laboratories around the world is also being helped by the evolution of global information networks. Indeed, these networks are allowing the real-time management and operation of laboratories in any part of the world. Thus, companies are gaining a competitive advantage by using the global knowledge resource and working with a global time clock. The trend is also being fuelled by the shortage of R&D personnel in some emerging high technology areas in industrialized countries. The companies have to bridge that demand-supply gap in skills by external outsourcing. Obtaining access to high-quality scientists, engineers and designers is on the top of the agenda of many major companies now. The demographic shift in the western world means that a country like India with its relatively favourable demographic profile with a large proportion of working and talented young people can become a global innovation hub, from which not only outsourcing of innovation will be done, but in which R&D based innovation centers will be set up by the western companies. Indian advantage will not just be cost but cost-cum-competence, considering the huge talent pool. A German software company set up in Bangalore recently showed that the ideas generated per employee were on the average three and a half times higher in their outfits elsewhere in the world! The winds of technoglobalism are bringing in a silent revolution in India. It is rapidly becoming a global R&D hub. More than 100 companies around the world have set up their R&D centers in India just during the last five years. The biggest would be the R&D center of General Electric (GE) at Bangalore. Its current size of 1600 employees will increase to around 2400 employees, making it the second largest R&D centre of GE in the world. What are the real and unique opportunities that India offers for becoming a true global R&D platform? The cost of doing R&D is fraction of that in the developed world. Last year, the entire spend of India's R&D was $5 billion, less than the R&D budget of one company like Pfizer alone! A dollar in India delivers so much more than anywhere else in the world. There is a world-class technical manpower. India has over 250 universities, 1500 R&D units, several IITs and engineering colleges. It has the world's largest chains of publicly funded R&D institutions. This is an extraordinary rich resource, which was underutilized even within the Indian space of R&D opportunity. India's emergence as a global R&D hub has a social, economic, political and strategic significance. But in what way will this help India? Can we not argue that the real benefit of all this will be to the foreign firms and not to the Indian firms? In other words, the migration of talent that was across the national borders will be now within India itself. Is it good or bad for India? What would be the impact of this on "brain drain"? One school of thought is that there will be gradual reversal of brain drain. A normal Indian scientist would love to stay in India, provided he is given a challenging job here. He would love to have his children grow up here in India. All this would become possible for him as India becomes a great R&D web, with world's best companies doing their most challenging R&D here in India, whether it is Intel designing its latest chip or GE designing its latest aero engine! As India become a global R&D web the demand on science will increase enormously. This will lead to the demand on the creation of new human capital, both in numbers as well as quality. Production of 5000 PhDs annually is too small a number for India, which is one sixth of humanity! This number had not grown, since there was no demand on science in Indian industry with some notable exceptions. This number can be raised to 25,000 PhDs or even higher. This will augur well for India. Another implication is that there will be enhanced competition among institutions and firms to seek the best brains to work for them. This will automatically mean that the institutions will really have to create an intellectually stimulating, rewarding and hassle free environment to keep these researchers with them. Competition will draw the best from everyone and will benefit everyone. The Indian industry itself will benefit in the long run. The researchers who will work in these non-Indian innovation enterprises will acquire insights and skills, which would be impossible to acquire otherwise. All such Indians reside abroad today. No more so. In the coming years, they will prefer to reside and work in India. There will be enormous benefits that the Indian industry can reap out of this supply of superior R&D leadership The shift to India as an R&D destination will take place in several other areas. Take drugs and pharmaceuticals. The concern after the countries become TRIPS compliant in terms of accepting product patents after 1.1.2005 is that of access to cheap and affordable drugs. The R&D infrastructure in India provides a low cost option just as the large patient pool, trained doctors, good clinical diagnosis capacity and genetic diversity of the Indian people provide opportunities for clinical research. The increased emphasis on diseases for the poor coupled with the setting up of global health funds implies that there is a scope that India can become a destination of "global knowledge for global good through global funding". This offers opportunities for India pharma to create both "financial capital" as well as "social capital". Another implication is linked to India's positioning in the comity of nations. Imagine in 15 to 20 years time, around 25-35 percent of the new knowledge that will determine critically the industrial competitiveness of major firms around the world being produced in India. Take this fact along with the crucial dependence of the big economies on this new knowledge. It is obvious that India's interest in international fora cannot simply be ignored by these large economies, as all this critical knowledge capital will find its abode in the human capital that will reside in the innovation centres located in India. The impact of technoglobalism in India so far indicates that access to highly talented human capital is going to be the most important factor. The challenge is how to continue to tap the incredible dynamism of global R&D so that Indian institutions and companies can assume the leadership in creating high-wage jobs and building new industries. This will require a sustained commitment to investment in science and technology, to strengthen research infrastructure, development of capabilities and means to rapidly integrate new knowledge and technologies into products and gain access to growing global sources of innovation, development of technology centers and government incentives and protection, in particular protection of intellectual property extended to science-based high technology inventions. Government will have to play an increasing role to influence the turn of events, both positively and proactively. Goldman Sachs predictions show that by 2050 India will be the third largest economy after China and the US. By 2050, India has the potential to occupy the first position amongst the knowledge producing centers in the world.       ]]> <![CDATA[A Unique Model]]> https://biospectrumindia.com/news/95/2325/a-unique-model.html https://biospectrumindia.com/news/95/2325/a-unique-model.html Mon, 12 Apr 2004 16:02:00 +0530 Isis Innovation A Unique Model This subsidiary of the University of Oxford since 1997 has spun out a new company every two months on an average, in recent years Spinout of companies from the universities in the UK has been a very important activity. Cambridge and Oxford have been at the helm of things. Gone are the ivory tower images. In fact, University of Oxford has a very unique model. The University has a wholly-owned subsidiary, Isis Innovation Ltd. It is the technology transfer company of the University, commercializing the research generated by the University researchers and owned by the University. Explained Dr Tim Cook, managing director, Isis Innovation "Science research activity at Oxford comprises of 2,500 researchers in science and medicine, 2,000 doctoral students, and an annual research income of £219.2 million. The research income in medical sciences and life and environmental sciences is £83.2 million and £21.8 million, respectively, accounting for 56 percent and 15 percent of the total income. So we have focused to help those researchers who wish to commercialize the results of their research. We are involved in licensing of intellectual property, formation of new companies, and offering consulting and service contracts." Isis was established in 1988 and since 1997 started a major expansion phase. The University assigns its intellectual property to Isis (where there are no pre-existing exploitation arrangements) and Isis then evaluates, protects, and markets the intellectual property. In 2002, Oxford University Consulting became part of Isis, matching business-consulting needs with University researchers. Added Cook, "Isis has an administration group, physical science group, lifescience group, and business innovation and consulting group. Except for the administration team, each group has a head of the group, project managers, business liaison managers, among others. What I would like to stress is that preconceptions are misconceptions. Project managers are the key people. They are the people, who do identify and provide the bridge. You must understand the ground realty that there has always existed a tension between the research community and the business community. And we have played as the intermediary role for helping them. All the research is patented from our center." Isis provides researchers with commercial advice, funds patent applications and legal costs, and negotiates exploitation and spinout company agreements, and identifies and manages consultancy opportunities for University researchers. Isis works on projects from all areas of the University's research activities. It files, on an average, one patent application each week and manages over 350 patent application families. Isis seeks to license technologies to companies to develop and sell technology-based products. Licensees are sought from all technology and business sectors on an international basis. Since 1997, it has assisted in either options or licenses signed on 160 projects. Some of which would generate over £1 million in royalties. Added Cook, "Revenue will be a long time coming, but the licensee takes over patent costs (£30,000 for the first five years, £50,000 for 10 years). Besides, there is royalty sharing amongst the researchers, general fund, department, and Isis." It also helps the researchers market their consultancy and services expertise. It has helped in the formation of more than 30 University spinout companies. Pre 1997, there were 9-10 spinouts. "It was about a spinout every four years then, now it eight companies a year," informed Cook. The valuation of the spinouts in 2002 was £1,204 million. What has been the fund resource? "Isis has a patent budget of £1 million per annum and royalties. Then there is a University Challenge Seed Fund (UCSF) of £4 million and Isis College Fund of £10.7 million. Launched in 1999, the UCSF has been deployed into a total of 68 projects. The £4 million investment has resulted in equity stakes in 21 spinout companies, four completed licensing deals, and 35 active technology projects. Further, UCSF investees have been supported by an additional £20.4 million invested by business angels and VCs," explained Cook. So what's the success formula? Cook summed it: Management of the process. University entrepreneur culture, university technology transfer resource, and local professional environment, all three must develop together, but the university must lead the change. Ch. Srinivas Rao at Oxford Fisher Scientific International and Apogent Technologies to Combine in $3.7 billion Transaction Fisher Scientific International Inc. and Apogent Technologies have announced a definitive merger agreement to combine the two companies. This strategic combination significantly bolsters Fisher's proprietary-product portfolio and provides the company with a $1.1 billion footprint in the high-growth life-science market. Paul M Montrone Under the terms of the merger agreement, Apogent shareholders will receive tax-free 0.56 shares of Fisher Scientific's common stock for each share of Apogent common stock they own. The combined company would have pro forma 2004 full-year revenues of approximately $5.1 billion and an enterprise value of approximately $9 billion, including $2.7 billion of net debt. The companies anticipate that the transaction will be completed early in the third quarter of the 2004 calendar year. "This announcement represents a major strategic milestone for our company and will create a more integrated and efficient global supply network for our customers," said Paul M Montrone, chairman and chief executive officer of Fisher Scientific. "With Apogent Technologies, Fisher Scientific has further enhanced its position in the life-science, scientific-research and clinical-lab markets and created a stronger platform for growth. Joining forces with Apogent enables Fisher to create efficiencies for our customers and value for our shareholders." The combination of Fisher Scientific and Apogent Technologies will result in several strategic benefits. Fisher's life-science footprint is expected to grow by more than 50 percent to $1.1 billion as a result of this combination. Further Fisher's position in biopharma-production and diagnostic-reagents will get strengthened. On the financial front, Fisher Scientific expects to achieve approximately $55 million of cost savings and other benefits in 2005. Fisher believes that the potential annual synergies could reach $100 million on an annualized basis by the end of 2006. These synergies will come from, among other things, manufacturing rationalization and facility consolidations. For 2004, Fisher expects revenue growth of approximately 27.5 percent to 29.5 percent, with approximately14 points of this growth from its combination with Apogent. For 2005, Fisher expects revenue growth of approximately 19-21 percent, with 11.5 points of this growth from its combination with Apogent. DRAXIS announces $20 million financing DRAXIS Health Inc. entered into an agreement with a syndicate of underwriters led by Desjardins Securities and including CIBC World Markets pursuant to which the underwriters have agreed to purchase, on a bought deal basis, 3,053,436 units of the company at a purchase price of C$6.55 per unit, for aggregate gross proceeds of C$20,000,000. DRAXIS Health is a specialty pharmaceutical company involved in the development, production, marketing and distribution of therapeutic and diagnostic radiopharmaceuticals through DRAXIMAGE Inc. and in the provision of pharmaceutical contract manufacturing services, specializing in liquid and freeze-dried injectables and other sterile products. Amgen to acquire Tularik for $1.3 billionmgen Inc., the largest biotechnology company, signed a definitive merger agre Roger M Perlmutter ement with Tularik, a pioneer in drug discovery related to cell signaling and the control of gene expression. Tularik Inc. will become a wholly-owned subsidiary of Amgen post the acquisition. Under the terms of the agreement, Amgen, in a tax-free transaction, will exchange Tularik common stock for Amgen common stock in a ratio that fixes Tularik's value at $25 per share. The value of the transaction is expected to be approximately $1.3 billion, net of estimated cash to be acquired and net of Amgen's existing ownership of Tularik of approximately 21 percent. The transaction is expected to close in the second half of 2004.Amgen expects that this transaction will represent an incremental increase of approximately $100 million per year in Amgen's investment in R&D for the next several years. "Tularik's research engine is a rare asset and a great strategic fit. Tularik has a strong team of scientists who share our desire to develop important new therapeutics in inflammation, metabolic diseases and oncology. Amgen and Tularik have complementary chemistry expertise and compound libraries that together strengthen and broaden our discovery capabilities," said Roger M Perlmutter, MD, executive vice president, R&D, Amgen.QLT to acquire Kinetek QLT Inc., a global biopharmaceutical company dedicated to the discovery, development and commercialization of innovative therapies to treat eye diseases, cancer and dermatology-related conditions, will acquire Kinetek Pharmaceuticals Inc., a Vancouver-based privately-held biopharma-ceutical company. Since June of 2001, QLT and Kinetek have collaborated on a research and early development program to develop signal transduction inhibitors for the treatment of eye, immune system and kidney diseases. Kinetek has a unique proprietary position on Integrin-linked kinase or ILK. Inhibition of the kinase activity of ILK has the potential of a broad range of clinical applications including cancer, inflammation, kidney, and eye diseases. In cancer, peer-reviewed published studies of small molecule ILK inhibitors discovered by Kinetek have recently shown that they block tumor angiogenesis and cause tumor shrinkage in animal models. Nucleonics raises $40.9 million Nucleonics Inc., a biotechnology company focused on the development of RNA interference-based (RNAi) therapeutics, has raised $40.9 million in a Series B private venture financing. The financing was led by New Enterprise Associates (NEA), and included major new investors HealthCap, Burrill & Company, Anthem Capital Management, and POSCO BioVentures Inc. Nucleonics' founding investor, SR One, Limited, was also a major participant in the round."We expect this financing to support the development of our lead product candidate through Phase II clinical testing, as well as to further the development of our technology platform overall," said Robert Towarnicki, Nucleonics' president and chief executive officer. The company is currently developing applications of its expressed interfering RNA therapy for the treatment of chronic Hepatitis B (HBV) and Hepatitis C (HCV) viral infections and plans to file its first Investigational New Drug (IND) application in 2005.EXIMIAS announces $63.5 million placement EXIMIAS Pharmaceutical Corp., a privately held pharmaceutical company, announced the closing of a $63.5 million private placement through a Series D financing led by Cross Atlantic Partners (New York) and co-led by Quaker BioVentures (Philadelphia). EXIMIAS focuses on the acquisition, development and commercialization of unique oncology and infectious disease products. The company has three novel, late-stage products, THYMITAQ and ORATAQ for oncology, and MACROTAC for oncology and infectious disease. The company has raised $94 million in capital to date. Salmedix completes $45 million series c financing David S Kabakoff Salmedix Inc., a company developing promising oncology drugs, with an initial commercial focus on hematologic cancers, has completed the sale of $45 million of its Series C Preferred Stock. HIG Ventures led the round. "We expect this investment to provide Salmedix with adequate capital to advance our three clinicalâ€“stage products, including our lead investigational drug, SDX-105, which is currently being evaluated in a Phase II/III clinical program with non-Hodgkin's lymphoma patients," said David S Kabakoff, chairman & CEO, Salmedix. In addition to SDX-105, Salmedix has two drugs in Phase II clinical development, as well as several preclinical product candidates. A multi-center, multi-national Phase Ib/II study in patients with chronic lymphocytic leukemia was recently completed with SDX-101, a "first-in-class" compound. SDX-102, a targeted therapy for molecularly defined tumors, is in a Phase II trial to investigate its potential as a treatment for non-small cell lung cancer, pancreatic cancer and sarcoma.KÃ©mia raises $33.5 million Jean Deleage KÃ©mia Inc. has raised $33.5 million Series B Financing led by JPMorgan Partners. This closing brings KÃ©mia's cumulative financing to $53 million. KÃ©mia discovers and develops new, oral small molecule medicines for well-validated, clinically significant targets. KÃ©mia applies proprietary chemistries and medicinal chemistry experience to two large and as yet underdeveloped classes of small molecule drug opportunitiesâ€”alpha helix interactions and allosteric kinase inhibitors. These target classes include numerous potential drug discovery targets across major disease areas including inflammation, cancer, HIV, diabetes and bone diseases.KÃ©mia's first drug candidate, an allosteric kinase inhibitor for inflammation, is projected to begin human clinical trials early in 2005.Alta Partners closes $475 million in life sciences funds Alta Partners, one of the largest venture capital firms dedicated to life sciences, announced the closing of its latest funds, Alta BioPharma Partners III and ACP IV, with more than $475 million in commitments. The new funds exceeded their target of $400 million. The Alta funds will be invested exclusively in life sciences companies, ranging from start-ups to advanced clinical stage companies. With these closings, Alta Partners now manages seven venture funds aggregating approximately $1.5 billion in committed capital. Since its founding in 1996, Alta has been one of the most active life sciences venture investors, funding over 90 companies. "These new funds strengthen Alta´s commitment to these sectors, allowing our team to work with leading entrepreneurs toward development of the most important therapies and medical advances of tomorrow," stated Jean Deleage, managing director, Alta Partners. Point Therapeutics to raise $13.5 million Point Therapeutics, a Boston-based biopharmaceutical company developing small molecule drugs for the treatment of a variety of cancerous tumors and certain hematopoietic disorders, has received $13.5 million in commitments from new and existing institutional investors for an equity private placement. Point will be selling 3,000,000 shares of its Common Stock at a price of $4.50 per share. Point plans to use these funds for general corporate purposes including the clinical development costs for PT-100, the company's lead clinical compound. "I am extremely pleased to announce this transaction," said Don Kiepert, CEO and president of Point. "This financing will give us the capital support to aggressively pursue our ambitious Phase 2 clinical plans for PT-100." ]]> <![CDATA[ASX to develop standards for biotech companies`]]> https://biospectrumindia.com/news/95/3456/asx-to-develop-standards-for-biotech-companies.html https://biospectrumindia.com/news/95/3456/asx-to-develop-standards-for-biotech-companies.html Mon, 12 Apr 2004 15:51:00 +0530 ASX to develop standards for biotech companies The Australian Stock Exchange (ASX) has decided to develop new listing and reporting standards for biotech companies that are spread out mainly at New South Wales (Sydney), Queensland (Brisbane), Victoria (Melbourne), South Australia (Adelaide) and Western Australia (Perth). The members of the AusBiotechâ€”Australia's Biotechnology Organization have consistently called for clear, consistent and effective reporting guidelines to assist companies in their communication with the stock exchange. "AusBiotech has and will continue to work closely with its members and the ASX to ensure that the standard for listing and reporting on the ASX is raised and guidelines implemented," said Dr Anthony Coulepis, executive director, AusBiotech. It is essential that AusBiotech, as the industry body representing over 1700 members in the biotechnology sector plays a highly active role in the development of the proposed listing and reporting rules. Members consider that without consistent guidelines in place, companies will interpret reporting requirements in different ways. AusBiotech is working closely with biotech companies to further educate and improve the standards for quality reporting. AusBiotech members encourage the introduction of any standards to be applied across the industry as a whole, rather than exempting specific areas, such as medical devices. AusBiotech members urge that any proposed new listing and reporting rules that the ASX might be considering need to be cognizant of the evolution and development of the industry. The listing and reporting guidelines should also be realistic in requirements, enabling higher standards and consistency in compliance without disadvantage to Australian companies. Five year plan to create jobs in RTR The regional business and academic leaders launched a five-year, $5 million strategy to generate 100,000 new jobs and increase employment in all 13 counties of the Research Triangle Region (RTR) in the US. Dozens of organizations in the region have agreed to collaborate on the strategy, called "Staying on Top: Winning the Job Wars of the Future." The strategy outlines 30 action items to nurture the growth of industry "clusters," interconnected business and support organizations. The goal is to spark business investment in high-growth industries that will create high-paying jobs for decades to come. "In the 1950s, a group of innovative leaders conceived the idea of the Research Triangle Park, an idea that changed the economic course of the region," said former Gov. James B Hunt Jr., who chaired the 37-member CEO-level task force that developed the action plan. "Today, we face intense global competition for new jobs and investment," Hunt said. "There will be regions of the world that win where standards of living will rise and jobs will be plentiful and regions that lose. We intend to win. We believe we can improve our chance for economic success through collaboration, education, innovation and action." The Staying on Top initiative grew from the findings of a 2001 study by Harvard University economist Dr Michael Porter, who conducted a comprehensive analysis of the Research Triangle Region. In his report, Clusters of Innovation, Porter concluded that the region required a 21st century economic vision to remain competitive. The task force of business and higher education leaders used Porter's study and new research to create a vision and action plan for the region. The action plan calls for institutional partners to pursue strategies in five different areas. The initiative will focus on developing industry clusters around eight technologiesâ€” Pharmaceuticals, Biological agents and infectious diseases, Agricultural biotechnology, Pervasive computing, Advanced medical care, Analytical instrumentation, Nanoscale technologies, Informatics. These areas have been chosen because the region is a world leader in their research and development and for their potential to create significant numbers of new jobs. RTRP is a public/private partnership that promotes economic development for the 13-county region of North Carolina comprising Chatham, Durham, Franklin, Granville, Harnett, Johnston, Lee, Moore, Orange, Person, Vance, etc. YIC to boost French biotechnology industry The French Parliament has adopted the status for the Young Innovative Company (YIC), which will make France the most fiscally attractive country in Europe for young biotech companies and their investors. The YIC status is expected to boost economic growth by making biotechnology companies more cost-effective and competitive, as well as better funded. This new legislation will dramatically reduce the tax and operational costs for biotech small and medium-sized enterprises (SMEs). The status will apply, starting January 1st 2004, to all existing or new biotechnology SMEs that spend at least 15 percent of their total annual expenditures in research and development, for eight years after their inception. This YIC status is expected to be a key driver in the creation of new biotechnology companies and in stimulating growth of existing businesses. Young biotech companies will benefit from: Full and uncapped social cost exemption for all employees involved in R&D projects for 8 years; Full and uncapped local business tax exemption for 8 years; Full income tax exemption for the first three profitable years and 50 percent relief for the following two years up to 100,000 euros ("de minimis" rule). In addition to this the French 2004 budget bill also includes incentives to the biotech industry such as additional measures to encourage innovation with, among others, an attractive tax and corporate status for business angels and a boost of the research tax credit. Canadian govt encourages biotech entrepreneurs To encourage new entrepreneurs in biotechnology, the government of Canada has come out with major announcements in its federal budget which include $270 million for new investments to the Business Development Bank of Canada, increased funding to federal granting councils, support for commercialization within government, universities and hospitals, as well as incentives for small businesses. The BIOTECanada, Canada's National Biotechnology Association has hailed the federal budget announcements on research and innovation, which will pave Canada's road to the 21st century economy. Janet Lambert, president of BIOTECanada stated, "The government clearly recognizes the importance of a partnership between the federal government and the Canadian biotechnology industry for the country to compete in the global innovation economy." "Canada has developed a strong foundation in research and development. Let's not lose this opportunity to create a strong 'Made in Canada' industry," said Lambert. BIOTECanada encourages initiatives that provide innovative industries with the critical capital they need to grow. However, quality of science alone will not provide the critical mass to ensure a sustainable self-sufficient industry. It represents the full spectrum of biotechnology in Canada, including the over 400 small, emerging companies and 12,000 researchers with more than 18,000 products and processes under development. Better conditions for R&D companies in EU The heads of states of the European Union, meeting at Brussels, are pushing to create better conditions for research-based companies like those based on biotechnology to flourish in Europe as over 50 percent of economic growth comes from innovation. EuropaBio has welcomed the declaration by the heads of state to ensure that public sector investment in R&D attracts matching private funding and to improve the general conditions for R&D investment using targeted support and incentives to encourage greater investment by business. "We would like to see the French initiative on the Young Innovative Company status being installed in other Member States, which would help make Europe one of the best places to invest and grow a company," said Johan Vanhemelrijck. "The Brussels summit conclusions will be really valuable if the Competitiveness Council in May takes them up and leads the way forward on biotechnology when Ministers will discuss the Commission's progress report," added Feike Sijbesma, chairman of EuropaBio. The EuropaBio hopes that the ministers will show political leadership both at EU level and in the member states to support an industry that matches economic growth, improves quality of life and a high level of environmental protection at the same time. German biotech industry looks at funding agencies Like India, the biotechnology industry in Germany has now entered a decisive phase. The industry needs venture capital, proceeds from contract research and investors who believe in the commercial idea of young entrepreneurs from the field of science. However, the market for venture capital is under particular pressure worldwide. The German biotechnology sector is feeling the effects particularly severely in its current set-up phase. It is now especially important that investors should quickly regain confidence in this sector of the future. Many promising innovations in medicine and health, the environment, nutrition and agriculture depend on developments in biotechnology. The same is also true of innovations in industrial production. As partners of research, many biotech companies have struggled to establish their own place in the market. In collaboration with other small and medium-sized enterprises, which have already gained experience on the market, or with large concerns, they have a realistic chance of surviving the consolidation phase. One must therefore expect an increase in the number of collaborations, mergers and take-overs. German biotechnology will emerge stronger from the current process of consolidation. The news about the bioclusters was compiled from www.ausbiotech.org, www.rtp.org, www.swissbiotechassociation, www.france-biotech.org, www.europabio.org, www.biotech.ca, www.bioregio.com     ]]> <![CDATA[The Making of India's first biotech IPO]]> https://biospectrumindia.com/news/95/1183/the-making-of-indias-first-biotech-ipo.html https://biospectrumindia.com/news/95/1183/the-making-of-indias-first-biotech-ipo.html Mon, 12 Apr 2004 15:36:00 +0530 An important chapter in the Indian biotech industry was written when Biocon Ltd opened its public issue on 11 March and closed on 18 March. Biocon's IPO generated an overwhelming response. The total demand was in excess of Rs 10,000 crore. The overall issue was not only oversubscribed by about 32 times, but over 90 percent of the demand came at the top end of price band, i.e., Rs 315 per share. There was large-scale participation by Qualified Institutional Buyers (QIBs), High Networth Individuals (HNIs) and retail investors. In fact while the retail portion was oversubscribed 14 times, the subscription for the HNI and QIB category was close to 39 times. BioSpectrum looks beyond the fundamentals that went into the Biocon issue to understand how the issue was planned and executed. Team Biocon on success ladder Three years of preparation â€¦ The IPO did not happen overnight. It did not happen in a couple of months. In fact, "The thought of taking the company public was there on the radar since 2001. This was the time when the biotech industry was booming. The other factor was the coming of NASDAQ to India. And we set for ourselves a target that we should go for an IPO in the future," said Kiran Mazumdar-Shaw, chairman and managing director, Biocon. But Biocon wanted to achieve certain things and reach some milestones before going public, as at that time it was a small company. These included things like getting used to the public face and making public disclosures. As a private company, quarterly reporting was not a practice. At that time, Biocon was only doing half-yearly reporting. "We wanted to go public, when we could show eight quarters of quarter-on-quarter growth. The reason: if that was achieved, then we would be disciplined and ready to go for an IPO," explained Kiran. Biocon had an active Board that had the experience of taking companies public. Board members Dr Neville Bain and Prof. Charles L Cooney had the experience to guide through the processes and mechanisms of getting to an IPO. Engaging the merchant bankers â€¦ It was in July 2003 when Biocon really set out to go public. It was decided to go public within the next one year then. "When it was decided, we set ourselves a very well worked out time lines. We knew it would take us an X number of months to bring out the prospectus," pointed out Kiran. Of course, it had initiated some activity much earlier itself. For instance, in 2002 itself Biocon started with the process of looking at the merchant bankers and who could be used for its IPO. Biocon wanted a merchant banker who could understand its business and showcase it in the right way. Reasoned Kiran, "The one thing we were very keen on doing was we wanted to start a new sector, the biotech sector. We did not want it to be clubbed with the pharma sector. It must be understood that the biotech business is knowledge driven with long gestation periods and is process intensive. Besides, the whole business model was different. Therefore we wanted to capture the value for the intellectual value that we are creating." So in 2002, it made each of the merchant bankers give a presentation on what Biocon was in terms of a story to sell to investors. It chose three merchant bankersâ€”DSP Merrill Lynch, Kotak Mahindra Capital Company and HSBC Securities. In that sense the process started almost 20 months back. "But even then we knew it would take at least two years before going public," said Kiran. Determining the right denomination â€¦ Last January was when Biocon started looking at the exercise pretty seriously. It drew a timetable on how to progress with the process of financial due diligence, legal due diligence, etc and went through the process of hiring legal firms and financial firms. Ernst & Young were its auditors and they had to cast its accounts as per Indian and US GAAP for five years. Further, Biocon had to go through a major exercise of arriving at the share value and the size of the share. "Historically, the face value of each share was Rs 100 and obviously we could not go with Rs 100 a share and charge Rs 1,000. So we had to arrive at the right denomination. Also we had a lot of reserves and surpluses. So we had to make the capital structure complaint to what we were trying to do in terms of going into the market," informed Kiran. "That was quite a process, as there had to be frequent board meetings and resolutions had to be passed. The employees' component also needed to be properly addressed." Learning curve â€¦ According to Kiran as the company believed in good governance, it did disclose as much as possible. This itself was a good learning experience. "You learnt to project the story in the way you want them to understand. What was that they felt as high value and what interested them? Of course, there was an array of analystsâ€”from pharma specialists to biotech specialists to generalists. Depending on who those analysts were one suddenly learns how to pitch the presentation. It was an interesting exercise and almost a practice for dealing with the analysts, which will now be a routine phenomenon," recounted Kiran. Generating interest â€¦ Biocon held several road shows in the process not just in India but also globally. An extensive road show was organized in the US in September and December 2003. The road shows were done across the USâ€”New York, Boston, San Francisco, Denver, Los Angeles, etc. It did a road show in London and Frankfurt. It did two road shows twice in Asiaâ€”Hong Kong and Singapore. What were the investors interested in? "The Indian investors were all focused on statins, whereas the foreign investors were interested in the insulin story, the capabilities that we had in protein manufacturing, custom research services, clinical opportunities, etc. So it was interesting to know where each one came from. It is a good practice to pitch your p IPO Details â€¢ Issuing 10 million shares, equivalent to 10 percent of its post-issue capital (Rs 1 billion) through 100 percent book building method. â€¢ The price band has been fixed at Rs 270 to Rs 315 per equity share of face value of Rs 5. â€¢ Issue opened on 11 March and closed on 18 March. â€¢ DSP Merrill Lynch and Kotak Mahindra Capital Company are the Book Running Lead Managers while HSBC Securities & Capital Markets (India) is the Co-Book Running Lead Manager. Karvy Consultants is the registrar to the issue. Financial Advisors to the company was Allegro Capital Advisors â€¢ The total demand was in excess of Rs 10,000 crore   resentation," explained Kiran. Biocon wanted to demonstrate that it was a professional company and had good management depth and manufacturing capabilities. Kiran could project all this quite easily to the audience that did not know Biocon very well. But in India her whole objective was to tell that Biocon was not Kiran Mazumdar. "People did not realize how big this business was and how big the company was. Because I am the face, they thought it is some boutique operation. They had some preconceived impressions about Biocon, which had to be changed," added Kiran. Butterflies in the stomach â€¦ There was a lot of interest from even those foreign investors, who are not normally ready to visit. Reasoned Kiran, "Bangalore is slightly off the beaten track. They are eager to look at IT, but for the pharma group they go to Delhi, Mumbai or Hyderabad. Nobody comes to Bangalore because there is no major pharma sector. But these groups' efforts to come to Bangalore made a statement that they were interested." Of course, they came at a time when the merchant bankers really got Kiran worried. It was a time when there was a spate of IPOs in the market. "Despite this, we did not change the timing as we wanted to stick to our schedules as planned. We were not even overlapping with the IPOs, as the issue size (Rs 350 crore) was very small. Further, we believed that the interest in our sector would be different from the government sector. The doubt about not doing well, if at all, lay only in the retail sector. We were sure we could make the shortfall, if any, in that segment through the institutional investors." The doubts were put to rest as soon as the IPO opened. In fact, the retail side got oversubscribed by 14 times and there was about 39 times oversubscription of the HNI and QIB. "Yes I was worried for two days. But that worry lasted for only two days. People were saying we were offering the stocks at a very high price band. But it must be remembered that when a company goes for an IPO, the company should capture the right value for what it does. The investors should then get good value for the future," explained Kiran. The argument in favor of this is that an IPO is not about just rising cash, unless somebody is desperate. The objective of Biocon going the IPO route was three-fold. One, give an exit for the private equity investors; two, give value for the stock options that Biocon had created. The third one probably was the most important consideration. It wants to have a public profile that would be tracked globally. Biocon has global aspirations and aims to become a global company, which is visible and properly tracked. "Further we had come to a point, where we had demonstrated that we had reached the level of critical mass in terms of size, growth, and capability. We are at the take off stage, where we can provide a good opportunity for the investors to grow too. Please do not expect Biocon as a bonanza investment, which will give instant returns. This is a very valuable long-term stock." Preparing to manage investor expectations â€¦ "One of the things is to look at what the investor expectations are. Is it about quarterly growth or new announcements? We have to be very sensible and mature about the announcements that we make. For instance, I don't think, I want to get into that quarterly guidance and forecast kind of profile. That is the worst thing to do. In the biotech sector, one should not attempt to do so as the sector is too dependent on the regulatory approvals. But we need to be very clear in our mind as to how we want to be perceived," commented Kiran. Biocon certainly will be making quarterly announcements of its financials. Besides, it also will announce from time to time about the exciting things happening at Biocon. The company also intends to encourage the investors to visit its facilities to see what Biocon is doing. For instance, this year itself it would be inaugurating three new facilities. These are the kind of things that Biocon hopes will give the investor confidence. The people behind the scene â€¦ The entire management did a great job, said a beaming Kiran. Murali Krishnan, president, finance, and MB Chinappa, general manager, finance, did not sleep for days. Then Shrilumar Suryanarayan, president, R&D, Ajay Bhardwaj, president, marketing, Dr Arun Chandavarkar, president, operations & technology, Dr Gautam Das, COO, Syngene and Dr AS Arvind, COO, Clinigene, all did a fantastic job. And outside the company, the merchant bankers, the legal advisors, the board, every one did things in a time-bound fashion and all took it as a personal commitment. The team is very important and increasingly they would be talking to investors and analysts. What would change for Kiran after the listing? All these years Kiran had no one to contend with except her board of directors and colleagues. She had a limited number of people to convince before taking any decision. A lot of things she would automatically have done in the past would not be done. She may not be able to do things mid-term. "We have to wait for AGM. May be some speed of doing things may be lost. I do realize that I am answerable to lot more people. But having said that the opportunities for the company will be much larger than before. Hopefully we can create a big global name for ourselves," believes Kiran. Now, it is about allocating the stocks and the listing. The listing will hopefully take place between 7 April and 10 April. Then, it is back to business and not to be carried away by the stock fluctuations. And then prepare for a global listing. N Suresh & Ch. Srinivas Rao ]]> <![CDATA[Outsourcing buzz in Indian biotech bay]]> https://biospectrumindia.com/news/95/2958/outsourcing-buzz-in-indian-biotech-bay.html https://biospectrumindia.com/news/95/2958/outsourcing-buzz-in-indian-biotech-bay.html Mon, 12 Apr 2004 15:31:00 +0530 According to a report on clinical research by the Confedera tion of Indian Industry (CII), the contract research service market is estimated to be around $9 billion. "There is an increased global trend towards collaborative outsourcing," the CII report says. The global outsourcing pre-clinical work and clinical research accounts for nearly $13 billion. Human Genome Inc eager to foray in India Human Genome Sciences Inc has shown interest in the Indian biotech industry at the Global Partnering Summit organized by Frost & Sullivan in New Delhi this month. Dr William A Haseltine, founder and CEO, Human Genome Sciences, informed that he is looking at opportunities to work together with Indian pharmaceutical and biotechnology companies for the discovery and development of new pharmaceutical products. "India is showing enormous change in its approach and the biotechnology industry here offers immense opportunities for the domestic as well as overseas firms. Looking at the presence of a vast skilled manpower due to the country's deep commitment to higher education, and the infrastructure for the biotech industry, we are seriously looking at possibilities to partner with Indian firms here," said Haseltine. According to Dr Haseltine, "Venture capital base has to be strong as capital flows where there is opportunity and India offers it in large quantity. Few people are aware that venture capital investment in the US biotech industry is not from the US alone. So, in India there is a need of establishing strong and aggressive venture capital fund for the biotech industry and research." "European companies from France, Sweden, among others, form the backbone of capital investment in the US biotech industry and the same can be brought here," he added. Talking about partnerships with Indian firms, Dr Haseltine said, "We use collaborations for the development of gene therapy products, small molecule drugs, and diagnostic products discovered using our genomics-based technology." Established in 1992 Human Genome Sciences Inc focuses on discovery, development, manufacturing as well as marketing gene-based drugs to treat and cure disease. It has nine products in clinical development, including drugs to treat such diseases as cancer, rheumatoid arthritis, lupus, hepatitis C and immuno deficiencies. But more importantly, according to Proximare Inc, a business consultant for pharma, biotech and related companies, over $200-million worth work is likely to be outsourced to India over the next 12 months in the field of biotechnology and pharmaceuticals. "There are around a dozen of biotech and pharma companies that are considering outsourcing their work to India through partners or starting a greenfield project. This can be a motivational aspect for the Indian companies to explore their dimensions. By looking at present scenario, we can predict that around $200 million work in pharma and related areas is likely to be outsourced to India in the next 12 months," said Nailesh A Bhatt, managing director, Proximare. "The companies looking at India for outsourcing are in the $50 million to $1 billion-plus category in terms of revenues," he added. According to Kiran Mazumdar-Shaw, chairperson and managing director, Biocon, the biotechnology industry in India holds a $9 billion market potential by 2010 across various industry segments, given the huge knowledge pool, a vibrant pharmaceutical industry and rich biodiversity that the country is showing. "The industry is expected to grow at 25-30 per cent per annum from the present level of $400 million," she emphasized. "While internationally, this sector has witnessed significant investment and venture capital activity, India is yet to emerge as a key player," Mazumdar-Shaw said at a Confederation of Indian Industry (CII) seminar. However, India is fast emerging not only as a destinationâ€”the prime source as well as the market for new generation pharmaceuticals, biotech products and diagnostics, but also as an international hub for contract research and manufacturing, she added. More and more pharmaceutical and life sciences companies are adopting complex networking, collaborative and outsourcing strategies in order to blend cost efficiencies with maximized innovation in the drug development cycle. Indian contract research organizations are becoming major players in this billion-dollar industry. This is one of the main reasons for the leaders of a renowned forum like "World Economic Forum" to incorporate pharmaceutical outsourcing subject into their agenda. Since 1986, the World Economic Forum and the Confederation of Indian Industry (CII) have held a yearly India Economic Summit in New Delhi. With hundreds of senior business leaders from India and abroad, foreign public personalities and members of the government and senior officials, the gathering is now acknowledged as the most important international business event in India. The list of companies considering outsourcing work to India include small to mid-sized pharma companies and biotech companies besides major pharma companies. Some of Proximare's clients include Merck, Bristol-Myers, Squibb, Warner-Lambert, Colgate-Palmolive, Sumitomo, InnoCentive and Pfizer. "Most of our existing clients are keen on setting up research and development (R&D) work in India," Bhatt said. The high quality knowledge base and low infrastructure costs are some of the key attractions of Indian biotech industry for the global audience. But it is time to understand India's own skill set for its development. Actually, it is a crucial aspect for drivers of the India's biotech ship. Faiz Askari   ]]> <![CDATA[Its time for yatras]]> https://biospectrumindia.com/news/95/2827/its-time-for-yatras.html https://biospectrumindia.com/news/95/2827/its-time-for-yatras.html Mon, 12 Apr 2004 15:23:00 +0530 Its time for yatras The political yatras for the ensuing elections in India commenced with Deputy Prime Minister L K Advani's 'Bharat Uday yatra'. Besides we have other yatras making waves in different parts of India. But there are some yatras, which will have some significance to the biotechnology industry. The mercury is rising. The fever is on. With elections barely after a month every political party is doing its bit to woo the voters. The political leaders are campaigning the length and breadth of the country. But there are a few leaders who are related to biotechnology/life sciences one or the other way and are making inroads through their 'yatras' to get the attention of the voters and return back to power. Narendra Modi, the chief minister of Gujarat, Ram Naik, union minister for petroleum and natural gas in the west and SM Krishna, the chief minister of Karnataka in south are to name a few. Yatras with ambition In the western part of India, Narendra Modi, the chief minister of Gujarat who is inviting the industry people to invest in Gujarat but is yet to announce the biotechnology policy for the state made a brief 'Narmada Poojan yatra' after the state government received the green signal from the Narmada Control Authority (NCA) to raise the Sardar Sarovar dam height to 110m. Subsequently he faced the wrath of the Election Commission, his yatra got stuck and got cancelled midway. To make a biotechnology related yatra the state has to first announce a biotech policy to entice the decision makers of the biotech and biopharma industry. Ram Naik, union minister for petroleum and natural gas, who took the lead in implementing the ethanol-blended petrol (biofuel) in the country and made waves about 'krishna kranti' (black revolution) by introducing a pilot project on biodiesel in Mumbai is running the 'Ram rath yatra' in his north Mumbai constituency (Lok Sabha). In the south, we have SM Krishna, the chief minister of Karnataka who initiated a biotechnology movement in the country by announcing the biotech policy for the first time in 2001, is spearheading the 'Vijay Dundhubhi yatra' in Karnataka to regain power for the second term (facing the assembly election). If he is able to win the hearts of the people through his yatra and regains power in the state, the biotechnology industry will have the chance to boom as his dream projects like biotechnology park and fund for biotech industry, still in the infancy stage, will be realized. Yatra for the industry Amidst the election campaigning but far from the political yatras we have one more yatra called the "Maha BioYatra". This yatra is not like the above-mentioned yatras. It has been making inroads into the Maharashtra biotechnology industry since August 2002. The latest program of the "Maha BioYatra" was a Cafe Scientifique, an interactive session with the renowned scientist and the former CEO of Human Genome Sciences, Dr William Haseltine. During the session he interacted with the industry and expressed his views on the opportunities for Indian biotech industry and the bottlenecks. Maharashtra's Maha BioYatra is a positive move as far as biotechnology industry is concerned in the state. The state government along with Confederation of Indian Industry (CII) has launched the BioWednesday network forum. The forum provides a platform for the industry people to discuss issues ranging from funding to marketing in the fields of life sciences, genomics, medicine, bioinformatics, agribiotech and marine biotechnology. Person behind the yatra The person spearheading this yatra is none other than Dr Swati Piramal, director, Nicholas Piramal India Ltd and also the member of the task force and mission on biotechnology set up by the government of Maharashtra. The objective of this yatra is to establish a strong network among the biotechnology industry, the academia and the policy makers. After its launch in August 2002, with CII presenting a road map for Maharashtra's growth through modern biotechnology to Dr Patangrao Kadam, the Industry Minister of Maharashtra, so far it has conducted four programs in the last one and half years. The last program on "New scientific policy" was held at Tata Institute of Fundamental Research in September 2003. If this program becomes a regular feature of the biotech industry in the state, which is moving at a snails pace with no support from the government, it will flourish and come up with many new biotech entrepreneurs. Besides the Maha BioYatra, the success of the yatras of the political leaders, who have some interests in biotechnology and are facing the voters in the coming assembly/lok sabha polls, will come as a big boost to the industry. Narayan Kulkarni ]]> <![CDATA[Nicholas Piramal expands its clinical facility at Wellquest]]> https://biospectrumindia.com/news/95/1685/nicholas-piramal-expands-its-clinical-facility-at-wellquest.html https://biospectrumindia.com/news/95/1685/nicholas-piramal-expands-its-clinical-facility-at-wellquest.html Mon, 12 Apr 2004 15:16:00 +0530 Nicholas Piramal expands its clinical facility at Wellquest Wellquest, Nicholas Piramal's clinical research division, an early mover amongst the professional contract clinical research organizations (CROs) in the country added a new clinical section with a 52-bed ward, a 6-bed ICU and enhanced services for clinical trials and data management to undertake phase I-III studies to further consolidate its position in the rapidly growing clinical research services sector. Dr William Haseltine of Human Genome Sciences Inc., USA, formally opened the facility that was fully compliant as per international requirements and GCP guidelines of ICH and the code of federal regulations of the US-FDA. Dr Satish Bhatia, president, Wellquest said, "We are poised for rapid growth with such augmented infrastructure. We will continue to provide quality services in clinical research to the international pharmaceutical industry." The bioanalytical section at Wellquest already has two LC/MS/MS machines and plans to increase the number to four. The core team of trained professionals managing the CRO is assisted by a number of scientific, medical and paramedical personnel totaling 65. The user-friendly design of the facility obviates the need for sending subjects or samples to remote sites for tests. Established in 2000 by Nicholas Piramal India Limited as an independent division, Wellquest's state-of-the-art facilities occupy 20,000 sq ft of space over four floors of the Wellspring Hospital in Mumbai. Pharmacogenomics center at Manipal with HP tie-up The Manipal Academy of Higher Education (MAHE) and Hewlett-Packard (HP) India are collaborating in setting a Centre of Excellence (COE) in Pharmacogenomics at the Manipal Campus. MAHE has signed a Memorandum of Understanding with HP India Sales Ltd for enhancing the campus experience of students and to support creation of the COE in pharmacogenomics. The centre of excellence is under creation by Kasturba Medical College, Life Sciences Centre, medical research wing of Manipal. It will research new pharma and biotech products, using the genomics platform. Genomic research requires analysis of large amount of clinical data, which is varied and in complex sets. Manipal has selected a HP platform. HP's contribution to the COE will include high performance servers, data storage devices, scientific software and professional consulting services. Speaking on the occasion Mr. DA Prasanna, member, board of management, Manipal said, "HP's technology will impact our courses in MIT making engineers more technology savvy. CII to lead India's Biotech Mission to BIO in June CII delegation at BIO 2003 in Washington DC BioSpectrum special issue to show case India's biotech strengths at BIO It will be "India Shining" at the world's largest biotechnology gathering under the aegis of the US Biotechnology Industry Organization (BIO) in San Franscisco in June. Leading Indian industry organization, CII, will be organizing a big Indian Biotechnology Mission to the prestigious event. The mission will be in the US from June 3 and participate in a big way at the BIO event from June 6 to 9. And BioSpectrum will be bringing out a Special Issue, in association with CII, to show case India's biotech strengths and attract the attention of the world to the Indian shores. For CII, this will be the third Biotech Mission to the US. And BioSpectrum, in the inaugural year of its launch itself has covered the happenings at BIO 2003 last June. BIO has chosen CII as the official contact for participating from India. CII director, Dr Sandhya Tewari said the organization has formulated a multi-pronged approach to maximize the visibility for Indian participants. CII is coordinating an "India Pavilion" at the BIO Exhibition. The Pavilion will provide an opportunity for companies and organizations from India, including state governments to showcase the unique strengths India has in this arena. CII is coordinating a special session at the main BIO Conference, titled "Harnessing Human Resource Capabilities and Information Technology Prowess: Biotechnology in the Future". It will also be organizing a parallel conference that will focus on partnering opportunities between Indian and global companies and VCs. CII has coordinated with BIO to have the CII delegation be accorded the status of an "International Delegation at BIO". Also, the CII delegation's visit will consist of one-to-one meetings and company visits prior to the convention. BIO 2004 will attract up to 20,000 top industry leaders, scientists, policy makers, academicians, and journalists from all areas of the life sciences industry. The new secretary of the Department of Biotechnology has kindly consented to lead this mission.In addition to this the delegation under the umbrella of CII, will host a reception for the external audience and dignitaries present at BIO. This proposes to be one of the highlights of CII's mission. Devinder Sharma lectures British MPs on GM products Devinder Sharma, noted writer, journalist and thinker on food and trade policy addressed British parliamentarians at the House of Commons on "GM Crops and the Developing World" on 23 March. His presentation analysed the implications of GM crops and genetic engineering for the developing countries. He also commented on the socio-economic causes of hunger and the impact that GM will Devinder Sharma have on agriculture-based economies in the South. His views will help the UK policy makers to fully understand the needs of the developing world and the potential impact of genetic engineering on production, poverty and hunger. The UK has a leading role in international development and could use its influence to ensure that developing countries can enact effective legal measures to regulate GM imports and secure legal redress and compensation in the event of negative impacts, as required by the Biosafety Protocol. It could also lead a reorientation of the research agenda towards safe, sustainable agriculture. This parliamentary briefing was organized by the UK Food Group and the Gaia Foundation. During his UK visit Devinder also spoke at a debate on "GM crops are good for us!" at the Natural History Museum, London and at the Scottish Parliament, Edinburgh.. Devinder Sharma is well known for his policy work on biotechnology, hunger, food security, sustainable agriculture, biodiversity and intellectual property rights, free trade, development and the environment. He is associated with numerous national and international organizations and civil society groups, and chairs the New Delhi-based Forum for Biotechnology and Food Security. He writes a regular column in BioSpectrum. IBAB organises dialogue on transfer of biotech knowledge The Institute of Bioinformatics and Applied Biology (IBAB), Bangalore is organizing a public-private dialogue on "transfer of knowledge in biotechnology" with case studies from India and Europe. It will be held on April 19-20 at Satish Dhawan Auditorium in Indian Institute of Science. Leading biotech entrepreneurs and researchers from India and Europe will attend the meeting. More details are available at www.ibab.ac.in Lupin commences herbal business The Mumbai based Lupin Ltd that conducts research in areas like New Chemical Entity, New Drug Delivery Systems and Phytomedicines unveiled its herbal business by launching nine products in a range of therapeutic areas including diabetes, pediatrics, GI, pain management and gynecology. Speaking on the occasion, Dr Kamal Sharma, managing director, Lupin Ltd said, "Lupin's herbal products are a fusion of heritage and science. We have used the time-honored principles of Ayurveda and married them to the advanced techniques of modern science to arrive at these products." He said that initially the products would be marketed through the ethical route. "We will target the Over-the-Counter (OTC) segment and the export markets once we have consolidated our presence in the domestic ethical segment," he said. "World over we are witnessing a quest for discovery of new molecules especially from the herbal or phytochemistry route. India having a rich heritage in the area of herbals and is well placed to participate in this quest." The herbal market in India and abroad has gained importance in recent days and many leading pharma players are eyeing this lucrative opportunity. Lupin intends to uniquely position its herbal range by leveraging its state of the art R&D skills, ensuring higher standardization of ingredients and conducting proper clinical trials. Briefing about the size of the herbal market, Ajey Kumar, vice president in charge of Lupin's herbal business said that the global market for herbal products is estimated to be around $60 billion while the Indian market is in the range of Rs 5,000 crore. Of this market, ethical products constitute approximately 50 percent of the market. "Herbals today have a growing international acceptance due to the fact that they have minimal side effects and offer a holistic healing approach. The global herbal market is growing significantly ahead of the allopathic market, with Germany and France accounting for almost 40 per cent of the total herbal products sold globally," he said. SIIL to launch combination vaccine in June Serum Institute of India Ltd (SIIL), a Pune based vaccine manufacturer has delayed the launch of its a new combination vaccine by a couple of months. Dr S D Ravetkar, senior director, SIIL informed BioSpectrum that SIIL which is working on quadravalent vaccine (combination of Hepatitis B-DPT vaccine) will launch the product in May-June this year instead of April. Briefing about the combination vaccine, he said, "The combination vaccine will reduce the number of injections, painful for children, by one. We are developing this indigenously as we have all the four components with us to develop the vaccine. Serum will be the only company after GlaxoSmithKline to launch such a combination vaccine in the world when it launches this vaccine. Even companies like Shantha Biotechnics and Panacea Biotec are also working on the same project. But these are dependent on components like DPT. Serum is a pioneering company in the manufacturing of DPT vaccines in India. Serum is working on this vaccine for the last three years. SIIL a flagship company of the Poonawalla Group of Companies is supplying the vaccines at subsidized prices to the Indian customers and to over 137 countries across the world. IIT Delhi and NIIT launch new bioinformatics program Launch of the Bioinformatics & Computational program The Supercomputing Facility of India's premier technology institution, IIT Delhi and IT education pioneer, NIIT have joined hands to create an intensive learning program for the bioinformatics field. The cutting-edge curriculum to be offered, under the aegis of Foundation for Innovation and Technology Transfer (FITT) at IIT Delhi, will equip a select number of science postgraduates to build exciting careers in the fast growing world of bioinformatics. Engineering and medicine graduates will also be eligible to enroll for this unique program. Speaking on the occasion, Prof RS Sirohi, director, IIT, Delhi said, ''The new millennium has ushered in rapid advances in bio-sciences, creating a deluge of information on genomics and proteomics with several scientific and technological challenges and opportunities. Any progress in this direction is of immediate relevance to society. The quest to meet these challenges creates a huge demand for highly skilled bioinformatics professionals. IIT Delhi is happy to partner with NIIT, the institution that re-defined the way IT education was delivered, to create a revolution of perhaps a bigger magnitude.'' International Data Corporation has estimated that IT spending in Biosciences will cross $138 million in India by 2005. The worldwide spend on use of IT in bioinformatics is also likely to spiral upwards with estimates of USD 20 billion by 2007. Reasserting the complementary nature of the formal and non-formal education systems, NIIT Chairman Rajendra S Pawar said, ''NIIT's association with IIT Delhi in the area of Bioinformatics is a reiteration of our commitment to prepare career aspirants for emerging technology professions.'' Spread over six months, the Program in Bioinformatics and Computational Biology includes thorough training in fundamentals of modern biology, IT and hands on training in bioinformatics on the supercomputer. While the bioinformatics modules would be offered at IIT, the IT modules would be delivered at NIIT's centres of excellence in high-end training. The supercomputing facility of IIT Delhi has the best computing infrastructure in the bioinformatics learning space in the country. Dr. A. K. Sengupta, managing director, FITT said, "NIIT's experience in providing software and learning solutions to a wide spectrum of domains enables it to create and deliver industry standard relevant skills. This partnership will help leverage NIIT's expertise in building an intellectual pool of trained professionals for bioinformatics." The pace of current developments and projections present information oriented new biology as the next wave in scientific development, thereby indicating their increased dependence on informatics and extensive use of computational technologies. Given the IT and mathematical skills of Indian students, the expectations from the country are quite high. Pharma R&D fund proposed Pharma R Pharma R&D fund proposed The Associated Chambers of Commerce and Industry of India (ASSOCHAM) has proposed a focused fund of Pharma R&D. For promoting autonomous drug development processes in the country, ASSOCHAM has submitted a proposal to the government for the formulation of "Pharmaceutical Research and Development Support Fund". In a note submitted to the government, ASSOCHAM president MK Sanghi suggested that there should not be any import duty on capital goods and consumables used by the biotechnology industry and there should be a tax holiday for ten years. Besides, the incentive package should also be more attractive than that offered to the IT sector. The fund would provide venture capital financing of high cost-low return R&D, ASSOCHAM said recommending that the management of this fund must be as an autonomous and knowledge-centered council. Sanghi has also recommended the institutionalization of a biotechnology regulatory commission that is charged with the responsibility of resolving conflicting interests and integrating coordinated development in biotechnology and related businesses and ethical/moral issues. There will be need for a regulatory framework that guarantees absolute privacy of an individual's genomic information, modification of the genetic code and various other issues relating to bio-safety studies. In order to give the necessary support to biotechnology IPRs across the country, patent offices should be modernized, physical and intellectual infrastructure improved with at least 300 examiners, a large number of them specially trained in biotechnology and bio-informatics. Besides, patent offices should be networked with research organizations throughout the country to keep track of research from early stages and identify potential and patentable areas, the proposal pointed out. DU to offer undergraduate course in biotech Delhi University (DU) will finally include biotechnology in its undergraduate program from the July 2004 academic session. However it has decided to open only 20 seats for this course. "The course was cleared by the university's academic council during its last meeting," informed DU pro-vice-chancellor CR Babu. The subject is already being introduced as an engineering programme at the Netaji Subhash Institute of Technology (NSIT) in Dwarka. Admission to the course at NSIT and DU will be through the usual combined entrance test conducted by the university. The Delhi College of Engineering (DCE) may also offer the course, provided it gets clearance from the All India Council for Technical Education (AICTE), before the session begins. Moreover, it is expected that if DCE gets the AICTE nod, a total of 40 seats (20 each at NSIT and DCE) will be available for the program. With the course being limited to engineering institutions and no general honours degree in biotechnology being offered by DU, things are not likely to be easy for students. Also the admission to the course will not be restricted to those who have studied biotechnology in Class XII. Earlier, the Central Board of Secondary Education (CBSE) had introduced biotechnology as an elective subject in Classes XI and XII and the first batch of students will pass out in May. About 40 Delhi schools have opted for the course. Bollgard farmers increase net profits by 78% Cotton acres are expected to increase in the kharif season. Bollgard farmers appreciate the tangible benefits of technology with reduction in pesticide for bollworm by 60 percent and increase in net profits for farmers by 78 percent. These are the findings of the study conducted by AC Nielsen ORG-MARG, a unit of Dutch publishing and information group VNU on use of Bt cotton at five states where farmers used bollgard seeds in the last kharif season. Ranjit Panda, project coordinator, AC Nielsen ORG-MARG said that inspite of the tasting the fruits about 10 percent of the farmers are undecided to use bollgard in the coming season mainly due to price factor. The farmers prefer to wait and watch. The study also revealed that the marginal farmers gained the most from bollgard against the medium and larger farmers. This is because of availability of labor in marginal farmers at their hands, said Ranjit Panda. Yousuf Ismael, research fellow, The University of Reading, UK noted that such findings were seen in other developing countries also. Bipin Solanki, deputy managing director, Mahyco Monsanto Biotech India Pvt Ltd (MMB) expressed optimism about the increase in sale of Bt cotton in the coming kharif season over the pervious years. In the first year MMB sold about 72,000 packets while in the second year it sold 2.14 lakh packets of Bt cottonseeds. The Mahyco Monsanto Biotech India Pvt Ltd (MMB), a joint venture between Monsanto and Mahyco, has commissioned AC Nielsen to study the benefits of Bollgard in the second year of its launching the Bt cotton in India. In the first year of its launch the MMB's product received a mixed response from the farmers due to various factors such as lack of proper monsoon, drought, etc. After cricket, biotech do warm Indo-Pak relations Pakistani government agencies have agreed to buy drugs and training material from Indian companies at an international biotechnology meeting, taking advantage of a recent thaw in relations between the two South Asian nuclear rivals. The deals came at the end of the three-day conference, which was focused on how Asian nations can use genetic research to improve health care and boost their economies. About 250 delegates from 25 countries attended the meeting. The conference also provided an opportunity for deal making, with 20 agreements signed, including three between private Indian companies and two Pakistani government agencies and one Pakistan-based firm. Pakistani delegates agreed to buy anti-snake venom, anti-rabies vaccines and training material. Syed Uzairul Ghani, who heads Pakistan-based Amason Vaccine company said Pakistani and Indian firms were also discussing the transfer of technology that would enable Pakistan to manufacture hepatitis B vaccines. New Delhi and Islamabad have taken recent steps to improve ties and address issues that have plagued their relations over the past five decades. Rai University to commence course on nanotechnology Rai University, a privately funded university with 25 campuses spread across India, will start a new course on Nanotechnology at its Mumbai campus from next academic year. The dean of the Bioengineering and Research Center of Rai University, Mumbai campus Dr VS Pingale, made this announcement at the concluding session of the two day national seminar on "Biotechnology and Bioinformatics: Challenges and Prospects" held at the campus. Inaugurating the seminar, Tarun Saxena, senior manager marketing, Biocon India pointed out the ethical issues involved in biotechnology. However, Dr AD Sawant, joint director, Higher Education, Mumbai stressed the need for regular interaction between academia and industry. Dr BN Ganguli, Agharkar chair professor, Agharkar Research Institute and Dr DA Bhiwgade, dean, Institute of Biotechnology and Bioinformatics released the souvenir. Dr Madhuri Sharon of Monad Nanotech Pvt Ltd, who briefed about the importance and scope for nanotechnology, said about 9-10 institutes are offering courses on nanotechnology in the world. In India Amity is the other institute, which is planning to offer courses on nanotechnology. Experts from the industry and academia made presentations on different topics such as biopharmaceuticals, prospects and challenges before bioinformatics, plant biotechnology, etc. In addition, the faculty and students made 15 presentations while 25 students participated in the poster presentation. More than 250 student delegates from different colleges of Goa, Satara, Nasik, Akola, Mumbai, Jalgaon attended the seminar, which focused on the opportunities and challenges in bioinformatics and biotechnology. Metropolis Health Services looking at CRO Dr Sushil Shah The Mumbai based Metropolis Health Services Pvt Ltd, a referral center for laboratory medicine in India, is planning to become a one-point solution to pharmaceutical companies, which are looking at taking up clinical trails in India. Speaking to BioSpectrum, Dr Sushil Shah, founder and chairman, Metropolis Health Services said, "We are looking at CRO, which is a big opportunity for the Indian pharmaceutical companies. We are formulating a plan to have facilities at other locations such as Bangalore, Ahmedabad, Hyderabad, Pune, etc." Dr Shah said, "To conduct trails we would utilize 500 free beds of Bangalore-based Ramaiah Memorial Hospital and 750 of Chennai-based Sri Ramchandra Medical College (SRMC)." Metropolis is planning to rope in 20-25 investigators from various specialties for the purpose. "Building upon our reputation for delivering the highest quality results with full-service flexibility in a changing healthcare environment, the clinical trials division is dedicated to serving the needs of drug development companies and contract research organizations for phase I-IV testing," said Dr Shah. Started in 1981 as Dr Sushil Shah's Lab with the objective to provide quality and standards in medical testing to Indians all over the country, it has now established itself as a reputed referral center for laboratory medicine. For more than a decade, Metropolis has successfully contributed to the analytical part of clinical trials (phase 1,2,3 and 4) and bioavailability studies carried out by various pharmaceutical companies and CRO's. Nicholas Piramal signs MoU with IISc The Mumbai based Nicholas Piramal India Limited (NPIL), a BioSpectrum top 20 company, has entered into "research collaboration" with the Indian Institute of Science, Bangalore (IISc) to identify potential new targets for developing drugs to treat fungal infections. Dr Swati Piramal, director, Strategic Alliances & Communication, said, "We aim to be an integrated pharmaceutical company with a commitment to discovery, development, manufacture and marketing of indigenous pharmaceutical products. With this target in mind, the company places a premium on promoting new concepts and individual inspiration from all sourcesâ€”external and internal". Dr Parag Sadhale of the Department of Microbiology and Cell Biology at the IISc will spearhead the collaborative effort. Dr Sadhale has already discovered novel genes, which are expressed only in agents that cause fungal infection. These genes are likely to provide new drug targets for developing anti-fungal molecules. Nicholas Piramal would have exclusive rights to commercialize any products coming out of this collaboration. NPIL already has a vast collection of natural products (over 6,000 plant extracts and 18,000 microbial strains), which will also be evaluated during this period. Commenting on the tie up, Dr Somesh Sharma, Chief Scientific Officer, NPIL said, "The last 30 to 40 years have seen very few anti-fungal molecules being launched. The world needs a safe and broad spectrum anti-fungal molecules and we hope to make that available" Leading pharma exporter to embark domestic market Promed Group, one of India's leading exporters to Russia in pharmaceuticals is now eyeing the Indian domestic market. Discussing company's future plans with BioSpectrum, Deepak Bahri, president, Promed Exports Pvt Ltd said, "We are proud on being an eminent Indian company as an exporter to Russian region in the pharmaceutical sector. But now we are working rigorously to embark the Indian domestic market with herbal products." Established in 1990, Promed Exports Pvt Ltd has now grown into an over Rs 35 crore company (2002-03) with an enviable compounded annual growth rate of 35.5 percent. "The company has set a target of achieving turnover of USD 75 million. (Approx Rs 400 crore) by the year 2010. And a major share of achieving this target will be coming from the upcoming herbal products section of the company," Bahri said. He also informed, "For achieving success into Indian market, we are planning to set up our own R&D unit near Delhi. The R&D unit will be focused on herbal products. About 2 crore of investment has already been chalked out for this project. The centre will be creating some 250 jobs for technical and non technical personals." Promed Exports is an ISO 9001:2000 certified organization and has been conferred the status of 'Export House' by the Ministry of Commerce & Industry, Government of India. The company has a stronghold in the CIS countries with an extensive marketing and distribution network. It is ranked the fourth largest pharma company exporting products from India to Russia (RMBC import data, Russia) after Dr Reddy's Labs, Unique Pharma and Ranbaxy Labs. Globally, out of about 1000 Pharma companies exporting products to Russia, Promed is ranked 60. ]]> <![CDATA[BJP bats for Biotech]]> https://biospectrumindia.com/news/95/6159/bjp-bats-for-biotech.html https://biospectrumindia.com/news/95/6159/bjp-bats-for-biotech.html Mon, 12 Apr 2004 14:41:00 +0530 BJP bats for Biotech N.Suresh The nation is in the election mood. Coupled with the onset of summer and the holiday season, one can safely assume that there will be a lull in the economic activity across the nation for the next few weeks. This, however, does not mean that there is a break in most new economy sectors. Certainly not in the globally integrated knowledge sectors. Have our leading political parties come to grips with the new realities of our globalizing economy? Will some of the issues, which are of concern to the modern sectors of the economy, figure in the dialogue between the potential rulers and the ruled? It has been a long tradition in our country for the political parties to seek the people's votes on the basis of a well-defined manifesto. It is no different this time. The country's top two political parties have released their proposed agenda to the people to judge for themselves. BioSpectrum examined these two documents in detail. The Bharatiya Janata Party (BJP)'s Vision Document and the Indian National Congress Party's Manifesto 2004 are the key documents, which will have bearing on the nation in the next five years. As BJP is expected to be the leader of the National Democratic Alliance, what it says in its Vision Document will have a major bearing on the NDA agenda. Here, from the biotech point of view, BJP has taken the lead. "We will fully support our biotechnology sector, which is making rapid strides," is an unambiguous statement that should gladden the biotech community. "We will also strive to develop Indian businesses in other frontier areas of technology, such as micro-electronics, nanotechnology, new materials, etc," says the BJP. There is not a mention of 'biotechnology' in the sleek Congress party's manifesto, which eulogizes the great achievements of its array of Prime Ministers in 45 years. The vision for the nation do not seem to have progressed beyond 1996 and clearly overlooks the major changes that have taken place in the world in the next eight years. Prof MS Swaminathan's repeated calls for a Second Green Revolution using the modern agricultural technologies too has been given a pride of place in the BJP's vision document. The BJP has promised to promote horticulture, floriculture, sericulture, and cultivation of bio-fuels, medicinal plants and bamboo in a big way. There is no specific mention of its stand on genetically engineered products. The party has expressed support to organic farming. Prime Minister AB Vajpayee has an excellent rapport with Prof Swaminathan who has been given the task of revamping the regulatory framework and facilitate introduction of latest agricultural technologies. Should the party be returned to power, many of Prof Swaminathan's suggestions will get implemented quickly. Biotechnology industry has been demanding greater interaction between government-owned research centers and industry. BJP seems to have understood the importance of this has clearly stated its move to expand the partnership between Indian businesses and CSIR, DRDO, ICAR, ICMR, ISRO, BARC, IITs, universities and other government-supported research institutions. The party has also promised to actively encourage more foreign companies to set up their R&D centers in India or start joint R&D activities with Indian entities. More than these, BJP's commitment to remove all obsolete laws, unnecessary procedures, and habitual litigation; non-financial barriers to economic growth such as delays in clearances and decision making would be welcome gladly by the biotech industry. ]]> <![CDATA[Biotech Frontier]]> https://biospectrumindia.com/news/95/2577/biotech-frontier.html https://biospectrumindia.com/news/95/2577/biotech-frontier.html Wed, 17 Mar 2004 18:21:00 +0530 North West England's Northwest region is leading the next wave of successful biotechnology growth in Europe. The region's biotech activity is thriving as a result of focus vision and the right ingredients of strong academic and clinical base, the commercial skill base in pharma sector, and infrastructure. The two key champions of the regionâ€”The Northwest Development Agency (NWDA) and the Northwest Science Councilâ€”recognizing life sciences as the key to economic growth in the region set up Bionow in 2000. Bionow has encouraged and nurtured this growth by creating an active, progressive community based on the region's academic success and strong presence of international pharmaceutical and biotechnology companies and supporting service companies. â€œBionow was the first in England to have a biotech strategy. Bionow cluster development programme focuses on biomedicine and covers pharmaceuticals, biotech, devices, and related health care. The cluster embraces the R&D based core companies, service and supply companies, entrepreneurs and investors, among other things. We have the one Bionow to support and facilitate business process,â€? informed Dr Linda Magee, head of Bionow, NWDA. All these efforts have pushed the fortunes of the region. â€œStudies completed last year indicated that 93 percent of the core companies have a single or predominant focus in human health care. About 61 percent of them specialize in therapeutics or diagnostics. We have looked into some of the investment profiles of the companies and found that the average investment per company had risen from £0.62 million in 2000 to £1.86 million,â€? said Dr Magee. There are about 175 life sciences companies. The base of the R&D companies in 2002 was about 72. Bionow is investing over £1.5 million to create an innovative training and research facility for Northwest biotechnology companies. The North West Institute for Bio/Health Informatics (NIBHI) will provide training and learning opportunities for Northwest companies to develop their understanding of biological and health informatics. The new facility, the first of its kind in the UK, will be managed by the University of Manchester, with funding and management input from AstraZeneca as well as significant support from the NWDA. The Institute, with a total investment of over £2.7 million, will operate out of new facilities in the University of Manchester and the University of Liverpool. Last year, the region had a major success in the form of £25 million worth of funding approvals. ]]> <![CDATA[Contacts]]> https://biospectrumindia.com/news/95/2073/contacts.html https://biospectrumindia.com/news/95/2073/contacts.html Wed, 17 Mar 2004 17:14:00 +0530 NORTHERN REGION British High Commission, Chanakyapuri, New Delhi-110 021 Tel: 011 2687 2161, Fax: 011 2687 0062; E-mail: comenq.newdelhi@fco.gov.uk States/Union Territories covered: Chandigarh, Delhi, Haryana, Himachal Pradesh, Jammu & Kashmir, Punjab, Rajasthan, Uttaranchal, Uttar Pradesh. SOUTHERN REGION British Deputy High Commission, 20 Anderson Road, Chennai-600 006 Tel: 044 5219 2151, Fax: 044 5219 2321; E-mail: bdhcchen@vsnl.com States covered: Andhra Pradesh, Karnataka, Kerala, Pondicherry and Tamil Nadu. British Trade Office, Prestige Takt, 23 Kasturba Road Cross, Bangalore-560 001 Tel: 080 2210 0200, Fax: 080 2210 0400; E-mail: bto.bangalore@fco.gov.uk British Trade Office, H No. 3-6-322, Chamber 104, Ist Floor, Mahavir House, Bashir Bagh, Hyderabad-500 029 Tel: 040 5566 9147/48, Fax: 040 5566 9149; E-mail: btohyd@hd2.dot.net.in EASTERN REGION British Deputy High Commission, 1 Ho Chi Minh Sarani, Kolkata-700 071 Tel: 033 2288 5172/76; Fax: 033 2288 3935; E-mail: bdhccalc@giascl01.vsnl.net.in States covered: Arunachal Pradesh, Assam, Bihar, Chattisgarh, Jharkhand, Manipur, Meghalaya, Mizoram, Nagaland, Orissa, Sikkim, Tripura, West Bengal. WESTERN REGION British Deputy High Commission, Maker Chambers IV, 2nd Floor, 222 Jamnalal Bajaj Road, Mumbai-400 021 Tel: 022 2283 0517, 2283 2330; Fax: 022 2202 7940; E-mail: bdhcnet@vsnl.com States covered: Goa, Gujarat, Madhya Pradesh, Maharashtra. British Trade Office, 404, Kaivanna, Near Ambawadi Circle, Panchwati, Ellisbridge, Ahmedabad-380 006 Tel: 079 646 7138; Fax: 079 640 3537; E-mail: btoabad@icenet.net In addition, information about doing business in Britain can be obtained from Business Information Centres at: The British Library GTB British Complex, Roshanpura Naka, Bhopal-462 003 Tel: 0755 553 767, Fax: 0755 765 211 E-mail: bicbhopal@vsnl.com The British Library SCO 36-38, Sector 8C, Madhya Marg, Chandigarh-160 008 Tel: 0172 546 540/546 541, Fax: 0172 547 540 E-mail: bic.chandigarh@in.britishcouncil.org The British Library 917/1 Fergusson College Road, Shivaji Nagar, Pune-411 004, Tel/Fax: 020 567 1580 E-mail: bicpune@vsnl.com  Website www.uktradeinvest.gov.uk ]]> <![CDATA[â€œEnforcement of IPR is a key challenge before the Indian biotech industry,â€?]]> https://biospectrumindia.com/news/95/3608/enforcement-of-ipr-is-a-key-challenge-before-the-indian-biotech-industry.html https://biospectrumindia.com/news/95/3608/enforcement-of-ipr-is-a-key-challenge-before-the-indian-biotech-industry.html Wed, 17 Mar 2004 17:14:00 +0530 William Pedder, Chief Executive, Inward Investment Group, UK Trade & Investment In September 2003, the UK Trade & Investment, a government agency of United Kingdom has established a team to identify and work with various stakeholders and partners to promote the international business activities of the companies, universities and research institutions in the biotech/pharma sector. The team has developed a network in India and was able to bring in some kind of coordinated approach to promote international business activities and concentrate on activities where it adds value to the activities of UK business. BioSpectrum spoke to William Pedder, Chief Executive, Inward Investment, UK Trade & Investment, who was in India to take part in the Nasscom event about the activities of UK Trade & Investment in promoting the biotech activities in India. Excerpts: What is the model UK Trade & Investment has adopted to establish a platform for the benefit of the biotech/pharma companies of both the countries? We are part of the UK government. Our motive and objectives are to assure that there are no barriers in doing business across the UK. Substantial and experienced firms do not need our support for doing business. But when it comes to acquisition, they may need legal support. In such cases we do not displease them. For SMEs, we provide free information on tax benefits, legal, regulatory issues, etc. We are ready to serve them for any help, but if they do it on their own, we do welcome them. We try to create a proper atmosphere for capital investments in the UK. We do offer ample and sufficient information on rules and regulations in starting a business in the UK and try to remove barriers coming in the way of making investments. We have a regulatory body, which is very transparent and helps in establishing rapport between the government and working group.  What are your programs to promote biotech/pharma initiatives in India? We do a lot of programs. First of all, we raise awareness about our initiatives and second, we do provide information through our website www.uktradeinvest.gov.uk. We do help people through introduction to the professionals. We do it in two ways through advisory services and through partnerships i.e., for technology transfers (partnering services).    We have a small program called global partnership. It is quite a popular facility. We are using that program in several countries. It helps in establishing joint ventures for development of technologies, technology sharing, etc.   As the first step, we work with events and activities such as trade fairs, seminars and missions. It helps us in developing a network of contacts within the government departments, trade associations, regional clusters, research and academic institutions and key firms. As we develop this network further, we will develop an understanding of regional issues, working closely with various regional organizations and developed administrations. We will also work in parallel with the UK industry and other government agencies to develop and implement a strategy that delivers corporate targets effectively.     Which are your focused areas as far as Indian biotech industry is concerned?  India is a developing player in the biotechnology sector. We see growth in biotechnology and pharma sectors in India. Centralized drug purchasing, generic drug manufacturing, international collaborations skills and cross border collaborations are our focused areas.  India has good intellectual skills. Matching the talents of India with the UK skills is another area we are looking at. However, the challenge before the Indian biotech/pharma segment is enforcement of the Intellectual Property Rights (IPR). The UK companies are bit worried about IPR in India. Hence the UK companies are looking at the US firms for tie-ups first, rather than Indian companies. In India, you initiated your biotech activities from Bangalore. What made you to look at Bangalore first to start your operations?  We felt Bangalore was the most ideal location to start our operations within our limited resources. It is an IT -BT hub and most of the companies in both these sectors are located there. Our next destination is Mumbai, a base for the Indian pharma industry. We move with the market and grow with the industry.   What are the achievements of the UK Trade & Investment in India after the establishment of a biotechnology and pharmaceutical team in September 2003? We have been in India for some time now. We have some Indian IT companies investing in the UK. Like IT, the level of interest among the Indian pharma and biotech companies too is deepening. Wockhardt did an acquisition in the UK. Our visit to pharma companies has doubled in the last couple of years. The companies that are into formulation, developing and manufacturing and looking at getting approvals for their oncology drugs in the UK are increasing. The companies are finding profitable business in customization and packaging of drugs. Fast moving companies do find opportunities in setting shop in the UK. And Indian companies are fast moving. Arvind Pharma has started its operations in the UK. We are very conscious that people may start with small operations but they will grow. We don't regret that people start off with a small operation. If the market is there, you will put more which is just what we have seen happening in the IT sector. Companies like Avesthagen and Sudershan Group have small operations to start with. What is the current scenario of the biotech industry in the UK? The UK biotech industry is significant and the largest in Europe. Over 60 percent of the European BT companies are based in the UK. We see over 500 BT companies. While the biotech is still taking shape in Europe, the industry has already reached the second stage of investment in the UK after a significant start. The industry has developed mainly due to the mixed form of capitalization. They have raised funds from VCs in Europe, the US and from angel investors. Your views on EU ban on imports of BT products... European Union has imposed a ban on import of GM products. However, we in the UK feel that the customers should be given a choice. We are part of the EU (a group of 15 nations). We have to go with the rules of the EU. GM food has become a political issue in our country. The GM food-producing firms from the US put pressure on the government of UK. But the government handled it in a balanced manner. We always wish that the people should get the benefits of the technology. â€”Narayan Kulkarni ]]> <![CDATA["India will see its strengths in manufacturing skills,"]]> https://biospectrumindia.com/news/95/1697/india-will-see-its-strengths-in-manufacturing-skills.html https://biospectrumindia.com/news/95/1697/india-will-see-its-strengths-in-manufacturing-skills.html Wed, 17 Mar 2004 17:09:00 +0530 ]]> <![CDATA[â€œThere are about 480 companies in the biotech area, employing about 23,000 people,â€?]]> https://biospectrumindia.com/news/95/2239/there-are-about-480-companies-in-the-biotech-area-employing-about-23000-people.html https://biospectrumindia.com/news/95/2239/there-are-about-480-companies-in-the-biotech-area-employing-about-23000-people.html Wed, 17 Mar 2004 17:09:00 +0530 Prof. Sir David King, Chief Scientific Advisor, HM Government, and Head of the Office of Science and Technology, DTI. What is the future of the UK biotechnology industry? Recent reports say that the UK biotechnology industry is under pressure and hasn't grown as expected... The biotechnology industry worldwide is under pressure. If we take the US as the leader in the biotechnology, which is the case, then you will see that all of the spinouts and the new business activities have gone through diminished activity. Since 2001-02, there has been a drop in the activity, largely driven by the shortage of the venture capital funding. Up to that point, venture capitalists were happy in investing in new ventures, anticipating that the results would come eventually. That particular bubble has burst. Now, they have become much more critical. Of course this has affected us as well. In the UK, we have the biggest hi-tech cluster in Europe for biotech as well as nano-technologies, which we call the golden triangleâ€”London, Cambridge, and Oxford. I know from a recent analysis that for 2002-03 in the Cambridge area, venture capital expenditure actually increased, while that in the US and Europe was decreasing. In fact, in 2002-03, 10 percent of the all venture capital funding went to the Cambridge cluster (10 percent of Europe's funding). So you get some indication from that figure, as Cambridge is only one part of that golden triangle. In fact, we have many good clusters developing in other centres too. The UK is still strong in terms of new companies emerging. If you ask me, am I optimistic about the future of the biotechnology industry? The answer is yes I am. What is the size of the UK biotech industry and what are its strengths? There are about 480 companies in the biotech area, employing about 23,000 people. There are many strengths amongst those companies. But you will know that we are very strong in the pharmaceutical industry. So it is not surprising that many of the biotech companies are linked into the pharmaceutical type. Post-genomics is generating companies; neuroscience development from the brain science research is seeing some spinout companies; bioinformatics is active. We are seeing some promising activity in stem cell research, not just in Cambridge and Oxford, but also in Sheffield. In the visualization and imaging area too there has been a lot of development. A company is working on general imaging technique, which is new in the Terra Hertz spectroscopy range. It is in the Terra Hertz range of the electro magnetic frequencies and the radiation is capable of going through many layers of clothing. For example, you can make a three-dimensional image of a person and find out if the person (in the interest of preventing terrorism) is carrying any explosive against the skin. Detecting a metallic object is easy, but this technique helps in detection of plastic explosives. It is a big breakthrough in technology. Why is this of interest to biotechnology? They have demonstrated that you can scan people's skin for cancer or so. There are many imaging technologies. Of course, the area of vaccine development is exciting too. Further, in the UK, there is a big project to stimulate the biotech activity. Developed by the Medical Research Council, this project will involve taking the blood and saliva samples from a wide number of people and follow their clinical history. Using the samples, we can analyze the genome and from the history, if we see that a small group of people has the tendency to develop a particular illness, we can trace it back to their genome. This is a project that will continue for many years. It is based on 500,000 people. The idea is in the future, we will expect to prescribe to people the drugs that will suit their own propensity based on the genome analysis. So post-genomics is a very important area. We have several general strengths. In fact, I have recently completed an analysis of the scientific strengths of nations and am sending it to Nature. My measure of scientific strength is the top one percent most sighted papers in every field and then looking at the national distribution. The UK's distribution overall is 11.5 percent. For the size of our population, we have few big impact areasâ€”medical science, life sciences, biological science, and environmental sciences. So we have a very good science density in the UK. I think it derives from a very long tradition. The important point is that the real strength is in the life sciences. What we are seeing through the biotech industry is that this is paying off. Does the UK biotech industry look to collaborate with overseas (particularly Indian) companies and/or scientific institutions and in which, particular, areas? Recently, the British Chancellor of the Exchequer Gordon Brown, in a speech to the business communities of the world, outlined that the areas where the government can best hope to act to stimulate this kind of activity was very simple. He said â€œwe should reduce the regulation and should invest in the science and skills baseâ€?. Because what the government can best do is provide a stable platformâ€”strength in knowledge from which the industries can develop. But what he specifically did not say is that we should promote a particular activity. This should be left to the market. Similarly, in terms of our biotech industry, we leave them to interact with the biotech industries of the other countries or to develop footholds in other countries. That is up to our companies. Of course, UK TI is actively promoting British companies abroad. But this is the oil to keep the wheels turning. With respect to India: You know that our Prime Minister was in Bangalore (it was on my suggestion that he came to Bangalore). He was impressed with a few chief executives that he met. And when he made a speech about science in the UK (Science Matters), in his introduction he referred to his time in Bangalore and said â€œI am worried that the Indian biotech industry would overtake ours because India does not seem to be faced with the public that is sceptical about GM, whereas our public is.â€? He was impressed and I am impressed too. But your biotech industry is still very young and still in an early stage of growth. Our industry is looking for partnership with an eye for win-win. They are more likely to look at the US, Germany, and other EU countries. But it is best, if you ask from the industry itself. As regards to the concerns what I can say from my visits to India is that the â€œapparentâ€? position on protection of IPR is very important to our industry. I think it is very important for India to clarify for our industry on exactly what the position on IPR is in India because our companies will not move with confidence into a country unless they feel that their IPR will be protected. That is an issue because I was there at the time of the Prime Minister's visits and this issue was raised several times with us. But things are now changing in India. You have a brilliant scientist RA Mashelkar, who is helping us a lot on IPR and I know that he understands the situation in India extremely well. And I know, it is moving in the right direction. What are the key principles of UK's biotechnology policy? The Bioscience Innovation Growth Team (BIGT) report lays out a policy. We are a fair trade nation and we believe as a free trade nation we should not put trade barriers to imports and equally we prefer to trade with nations that also do not put barriers. Free trade within a regulatory process, which is fair and balanced and science based is important. So if we take GMs, we have a very rigorous regulatory process looking at all aspects of GM technology and how it might impact on environment or health or animals. Only those new products, which can get through all of these careful scrutinies can be placed in the market. We believe in free trade, but carefully regulated in a fair way. We are particularly proud of our very strong links particularly between academia and government funded research institutions and industry. If you ask me what is the biggest change in the UK in the last 20 years? Then it is in that area. Our universities were often accused of being ivory towers. This is not true. The universities that were most often accused of being ivory towers were Oxford and Cambridge. Actually, Cambridge led the way out of it. Now the biggest hi-tech industry is around Cambridge with 50,000 employees working on all aspects. So it is a massive turnaround. Our government is supporting all of these developments by spending more on science. The budget through my office was £1.45 billion in 1997. Today, it is £2 billion (2004). In 2005-06, it will be £2.9 billion. So we will be doubling the science research budget. So here is the statement that government believes what it states. That is what the government can doâ€”invest in the science space, invest in the knowledge transfer activity into business, and this we do invest again from this office, and stimulate the industry with balanced regulatory process. We have a very important particular strength related to the biotech industry, which is the National Health Service. So one aspect of our work is to stimulate links between pharma, biotech, and the national health. What we want in other words is to bring new treatments from pharma-biotech industries into the National Health Service as quickly as possible so that our people benefit on health and the industry benefits from getting into markets quickly. We do provide some help to firms to get private and public finance. But what is nice is the new cultural change we have. This means many groups are setting up as venture capitalists. Many of them founded by people, who laid money in their early phase of spinout company activities. These are the business angels, who are working in these cluster areas and they are now putting back their money. Now we are also encouraging R&D activity in the industrial sector. The Chancellor has introduced tax credits. If a company can demonstrate that they are spending money on R&D environment, then they are given a tax credit against their expenditure. So we are encouraging companies to spend more money on R&D. How important is biotechnology in the UK's overall R&D efforts? If we take the important health problems that we are faced with, we see a problem with obesity. Infectious diseases worldwide are a big problem. So each of these problems creates a demand on our industry. So there is much for the biotech industry to do. But of course, the government sees manufacturing industry as a whole as an important target area. For example, aerospace industry is important. But if you ask me which is important? I will say it depends on the market. It is a very dangerous game to say it is going to be biotech because we may find areas in physical sciences and engineering such as aerospace also developing rapidly. So we have to provide the stable platform right across the space so that we can play to our strengths. Are there any ways by which the two countries can collaborate on research? We have a science and technology agreement between India and the UK. I am the UK owner of that agreement. So recently, I was in India discussing the progress on that agreement and we will have a full meeting shortly to discuss the progress. We have also established a new set of awards for the students who wish to come to the UK to do their PhDs. These are the Dorothy Hodgkin Awards. Dorothy Hodgkin was a Nobel Laureate and she took much interest in India, Africa, and China in particular when she was doing her research. What we have established now is a new set of awards that we want to see as the highest status awards for young scientists who want to really pursue a career in science. This will be fully funded by the British government and British companies. The scientists will study here and we expect them to go back to their countries and contribute to the development back home. The Awards are specifically for students from China, India, Hong Kong, Russia, and the developing world. So it is limited to those countries. My belief is that we (Northern world) have to be much more heavily engaged in capacity building activities in science, medicine, engineering, and technology. This is the start of our program. The first awards will be given in October this year. The awards will be offered by universities. In the first year, there are 130 awards, but we plan to increase it to 700-800 awards slowly. â€”Ch. Srinivas Rao ]]> <![CDATA[â€œThere is a science and technology network to help the scientists and science collaborations,â€?]]> https://biospectrumindia.com/news/95/1527/there-is-a-science-and-technology-network-to-help-the-scientists-and-science-collaborations.html https://biospectrumindia.com/news/95/1527/there-is-a-science-and-technology-network-to-help-the-scientists-and-science-collaborations.html Wed, 17 Mar 2004 17:07:00 +0530 â€œThere is a science and technology network to help the scientists and science collaborations,â€? Sir Michael Arthur, British High Commissioner, New Delhi What are the ways by which the UK and Indian companies can partner to mutually benefit? What are the steps taken to promote the UK-India relationships? In the wider context, there has been a rapid growth in British Indian trade relations. The trade between the two countries would roughly be worth $10 billion. That is partly in trade of goods and services. What we are also seeing is a significant growth in investments from Britain into India. India is now very big to Britain. And specifically in the biotech sector, we are seeing new interesting models of business partnerships. Quite often they are in the high value-added, hi-tech, and R&D sectors. There are genuine business partnerships, which means there is a bit of work, which is done in each of the countries. British companies are interested in contract work here and also in several other areas of biotech. They are also interested in chemical research and development of products. For example, there is inward investment in AstraZeneca in Bangalore to develop a new TB drug. This is the background of the 21st century cooperation in new economy areas, which is a complete change from what we had in the 20th century. Even in volume terms, this is higher than some of the conventional trade and investments. This is the way relations are going, as there is strong science in both the countries. So what is the British government doing to help them? We have a major trade and investment promotion operation across the globe. It is the biggest across the world. And with India, we have an identified sector on trade and investment promotion. We have a team to track the sector. That is one area. Then there is a science and technology network, which has science officers in Bangalore and Delhi who work as a team. That again is a huge departure. Three years ago, we did not have that. That will be stepped up to link the scientists and science collaborations, particularly in the biosciences sector, quite often at the research level rather than for business development. There is a third link, which is through the British Council, who in turn have a science policy aimed particularly at bringing new and young scientists together from both countries across all the different sectors. And Biosciences is one of the top priorities because it is one of the built areas in Britain and we would dial ourselves as the leading biotech destination in Europe. Though Germany has more number of companies, in terms of quality of work, we have an edge. That is the overall picture. I would like to give another example of this cross partnership in biotech. When AstraZeneca was setting up its company here in India to do work on the TB drug, Dabur, an Indian company, was investing in Britain to do work on a cancer drug. So you got a new model of partnership. I am a proponent of joint work where companies are investing into Britain and also doing contractual work with our universities and be equal part of the picture. It is a two-way street. It is not yet the case in bioscience area, but in ICT area it is happening. We are seeing some Indian IT companies floating their stocks internationally. Last year, the single largest equity float on the London Stock Exchange was by an Indian company. And there are more Indian companies on London Exchange than in New York or NASDAQ combined. And as biotech companies get to that scale, London is an obvious destination. Are there are any specific segments that you are targeting? We are open to proposals in any area. But I know we are looking into bioinformatics, drug research, clinical trials, and agribio. We have had a lot of work on GM crops, though there has been a lot of debate. But the government's position is that we need to get some common sense and science into this debate. So we have been trying to de-escalate the emotion and operate some sensible scientific debate. As a government, we are committed to GM products or work where they are safe. Another important area is the students segment. We are doing quite a lot to promote student exchanges and we are very keen on getting more Indian students into Britain for two-three reasons. One, our universities are very good in many specialized areas and good Indian students can benefit from that. Also the quality of Indian students we get is high. Some of the faculty members say that it is good for their faculty because the interaction with Indians is very positive. In the bioscience area, we have several scholarship schemes to help the students. We do about 100-120 scholarships each year across the board, not just biosciences, for various programmes. We have just launched a science-specific group of doctoral (PhD) scholarship, which is applicable worldwide. But India and China are its core targets. You are the two favorites. We make matters as easy as possible for foreign students. We have just increased the amount of time a student is allowed to work up to 20 hours a week, which means if a student needs to finance his studies, he can do that by working. This is very helpful particularly in the science area. Today, we are in the same ballpark as the US. Which are the other areas like IPR that needs to be lined out? You have IPR, process and patents coming in 2005. That is a crucial mission because the big investors here need to be satisfied that IPR protection is adequate. And that has been, in the past, a reason why big FDI investors have not knocked. Now, the legislation is in place but again it is going to be very important that the implementation, in particular, with the courts and processes gives proper protection to those who file patents. And if you do not have that and gain that international confidence there will be serious implications on Indian new economy businesses. So a lot of people want to come here but they need the right rules and regulations. What is the position on the visas? We have a huge visa process system. We give around 270,000 visas a year in India. All of them are for multiple entries and for a vast majority of the applicants, it is a pain-free process. We have started a new outsourcing operation, basically from our High Commission. We make the delivery of visa very fast for the students or for some one who is going to work for on assignment in Britain. We work closely with British companies that have done work skill attachments. This is a good sign of the link between India and Britain. The quarter of a million visas is going up 30 percent a year. We give twice as many number of visas to India as to any country in the world. What is the future of Indo-UK trade? It is growing fast and it is increasingly happening in goods and services. And I think the new economy areas will be a big part of it. And particularly the life science sectors. What are my priorities to try and help them? We have the Indo-British partnership, which is a trade forum. Then are links between CII and Consederation of British Industry (CBI) and FICCI and London and so on. There is a whole wave of business partnerships. We want to give another big boost to this relationship. Business and Science is part of the change and there are joint committees to address the same. â€”N Suresh ]]> <![CDATA[Excellence in Manufacturing]]> https://biospectrumindia.com/news/95/1334/excellence-in-manufacturing.html https://biospectrumindia.com/news/95/1334/excellence-in-manufacturing.html Wed, 17 Mar 2004 16:59:00 +0530 Wales Excellence in Manufacturing Wales has the critical mass to support biotechnology effectively. The cluster has over 90 biotech companies with R&D and manufacturing base and 140 plus biotech organizations with several big international companies located here. Amersham Biosciences is located in Cardiff and develops and manufactures products for genomics, proteomics, and drug discovery. Similarly, Bayer Diagnostics, Cell Factors, Argonaut Technologies etc. are present in Wales. CellFactors, Newport, is an interesting case. It is preparing to market its first human cell-based research product Skeletex. It shifted from Cambridge to Newport to carry on R&D in its neural cell technology, which is expected to be the answer for treating Parkinson's disease. With diverse expertise, it is well placed to assist companies in the bioscience area. A comprehensive package of support services is available for companies including contract manufacturers. The assistances include those for meeting US FDA and European approvals for biomanufacturing plants, funding and incentives for setting up new plants, and support in finding suppliers of special products. Besides there are specialized developers experienced in building biomanufacturing plants. The region is strongly committed to the development of its biotech activity. It has 200 sites with more than 4,500 acres of space available. Besides, there is space for offices and labs, which want to have close links to the academic research communities. Facilities are available MediCentre at the University of Wales College of Medicine, Swanese Innovation center of University of Wales Swansea, the Aber BioCentres in the Wales University, and BioTechnium in Swansea. The Welsh Development Agency and Wales Trade International are partners in Team Wales, a single dedicated point of contact in Wales. The good manufacturing platform is ably supported by quality research base. Cardiff University is among the top 10 universities in the UK and has strong foundation in biological sciences, medical genetics, medical biochemistry etc. It is very active in stem cell research too. In fact it signed an agreement with Center for Cellular and Molecular Biology (CCMB), Hyderabad for mouse genetic research and stem cell research. This is just an example. What's important, there are spinout programmes. For e.g., under the Wales support programme seven companies have spun out. ]]> <![CDATA[Commercial Biodiversity]]> https://biospectrumindia.com/news/95/1738/commercial-biodiversity.html https://biospectrumindia.com/news/95/1738/commercial-biodiversity.html Wed, 17 Mar 2004 16:59:00 +0530 South West Commercial Biodiversity The South West of England is particularly strong in bio-medical applications. The success of the biotechnology in The South West of England is a reflection of the UK model of essential strengths in strong bioscience base and growing entrepreneurial culture. It has wide a spectrum of biotechnology offering from agribio to manufacturing to marine sciences and bio medical applications. It is a strong pocket for bio-medical applications.  Like else where in the UK, bioscience has grown on account of proactive university business-support initiatives and collaboration with businesses. In the South West, there are three key locations where the bioscience activity has reached critical mass. These being: the Plymouth-Exeter arc, Bath-Bristol arc, and South West Wiltshire (Porton). The region has a good academic research base, with six of the 11 regional universities rated as â€œexcellentâ€? to biotechnology sector. For example in 2001, RAE, Bristol University had 18 science and engineering units rated as â€œinternationally excellentâ€?. Similarly, University of Bath has top-rated pharmacy department, including the Centre for Extremophile Research (CER). Besides there are several other public and private research organizations like the Centre for Applied Microbiology Research, the Plymouth Marine Laboratory, Brixham Environmental Laboratory, and the Campden & Chorleywood Food Research Association, which carries out research on behalf of its industrial membership. There are some 40-50 companies undertaking core R&D, 90-100 companies supporting the sector, and 10-15 developing companies (1-2 years). The region has benefited from the DTI's Biotechnology Exploitation platform. Further the South West of England Regional Development Agency (SWDRA) plays an active role in nurturing and developing the biosciences sector in the region. It works in collaboration with the support of organizations like BioApproaches, Bio Elf, and Western Arc, all of which provide business and professional development assistance for bioscience in the South West. A comprehensive package of support is available to biobusiness in the South West region. ]]> <![CDATA[Exciting Future]]> https://biospectrumindia.com/news/95/1814/exciting-future.html https://biospectrumindia.com/news/95/1814/exciting-future.html Wed, 17 Mar 2004 16:59:00 +0530 The UK Bioscience Exciting Future From the greatest scientific discovery of the 20th century, the double helix structure of DNA 50 years ago in Cambridge, Britain has been at the forefront of some exciting bioscience.   A visit to Cambridge and anyone would point you to the Eagle pub. The reason: it was in this pub that on 28 February 1953 one of the greatest discoveries was announced. Francis H Crick declared here that he and his colleague James D Watson had discovered â€œthe secret of lifeâ€?. Crick and Watson had discovered the structure of deoxyribonucleic acid (DNA). This revolutionized biology. The story of the UK Biosciences does not stop there. In 1997, Dolly, the sheep, was born. This was the first mammal cloned from an adult cell. In 2003, the human genome project was completed. Speak to any scientist, industry, or government official, they would narrate the success of science in the UK tirelessly. Prime Minister Tony Blair, in his foreword to Bioscience 2015 Report, wrote: The bioscience industry is a British success story. From the discovery of the double helix structure of DNA 50 years ago in Cambridge, Britain has been at the forefront of bioscience. Our academic and research scientists remain amongst the best in the world. The UK bioscience industry faces an exciting future... This track of excellent scientific discovery has led to the success of the UK's pharma and biotech industries. â€œThere are approximately 480 dedicated biotech businesses in the UK with over £2.8 billion revenues in 2001,â€? said Ian Young of Department of Trade and Industry (DTI), Bioscience Unit. According to Simon Sargent, pharmaceutical industry advisor, Bioscience Unit, DTI, the pharma industry employs about 65,000 people. Out of that 27,000 are employed in R&D and two of the world's top five pharma companies GlaxoSmithKline and AstraZeneca have their global headquarters in the UK. Sargent informed: â€œThe UK is the world's leading exporter of pharmaceuticals with exports in 2002 standing at £10,031 million. During the same time, pharma companies spent £3.2 billion on R&D, accounting for approximately 10 percent of the global R&D spending. And about 47 companies had 561 potential medicines undergoing clinical trials in the UK at the last count in August 2001.â€? The pharma story is very important for two reasons. One, most of the biotech companies in the UK today work on biopharmaceuticals. Informed Prof. Sir David King, Chief Scientific Advisor, HM Government, â€œWe are very strong in the pharmaceutical industry. So it is not surprising that many of the biotech companies are linked into the pharmaceutical type.â€? Two, the success formula of the pharma sector would be replicated in biotech too. â€œDTI, BioIndustry Association (BIA), and Department of Health (DH) have jointly come out with a report, Bioscience 2015. This is the Bioscience Innovation and Growth Team (BIGT) report, which has formulated a strategic approach for the future of the UK's bioscience industry. The success of the UK's pharma industry was on account of a similar report submitted to the government.â€?   Wide portfolio According to Tom Salusbury, leader, biotechnology & pharmaceuticals team, UK Trade & Investment, â€œThe UK biotech companies range from listed companies (up to â‚¬7bn market cap.), pre IPO companies (up to â‚¬70m market cap.), to start-ups and research bodies. The industry predominantly constitutes SMEs. The main sub-sectors include healthcare, environmental, diagnostics, agriculture, and industrial. And the companies are mainly located in clusters.â€? "The UK biotech companies range from listed companies, pre IPO companies, to start-ups and research bodies. The main sub-sectors include healthcare, environmental, diagnostics, agriculture, and industrial."  Tom Salusbury, leader, biotechnology & pharmaceuticals team, UK Trade & Investment The industry is very much based on small companies, though there may be some exceptions like Celltech, which has operations in the US as well. â€œThere are two-three reasons for that. Biotech is still quite a young industry. Also to some extent it is a matter of choice. Quite a number of biotech companies do not want to go too big. They want to stay very small and do first few phases of developing drugs and do not want to get into the next phase like the Phase-3 trials or getting the regulatory or marketing approvals. Some UK companies look forward to pharmaceutical companies to do that. For instance, Antisoma PLC, a biopharmaceutical company specializing in the development of novel anti-cancer drugs, has an arrangement with Roche worldwide to take some of its drugs into the market,â€? explained Young. The collaborative agreement gives Roche worldwide exclusive rights to R1549 (formerly Pemtumomab), R1550 (formerly Therex), AS1404 (DMXAA). Antisoma received an upfront payment of $43 million and will be eligible for milestone payments upon reaching key stages in development and royalties on any product sales. Amongst the 480 odd companies in the biotech, most of them would be in the health care. Some of those are working on vital technology platforms like medical diagnostics and drugs informed David Masino, senior policy advisor, EU & International Bioissues, Bioscience Unit, DTI.  Within the health care area, the UK companies are working on all sorts of disease areas. â€œBut genomics and proteomics, oncology, neurosciences, vaccines, and infectious diseases are major areas of expertise. Companies are also looking at tissue engineering. The sector is growing,â€? added Jeanette Walker, business development director, ERBI Ltd. The country has specialist biotech companies in the areas of agbio (animal health, agriculture, biopesticides and food technology), biodiagnostics (environmental and health care), bioremediation, biomaterials, bioprocessing, bioinformatics, functional genomics and high-throughput screening. Some of them involved in the agribiotech are mainly waiting for the GM crops policy. It is not that the agribiotech companies are working only in transgenics, they are also working on plant biotech for chemical extraction etc. â€œThe UK is also a major center of biomanufacturing, competing with Switzerland for leadership in the production of complex protein and DNA-based treatments,â€? said Dr Linda Magee, director of Bio Now.   Largest in Europe The sector wise figures were not available. But the industry experts pointed out that the UK biotech industry is the largest in Europe, though Germany has more number of specialist biotech companies. According to The New Economy Strategies (a Washington DC-based consultancy organization) report, England had 310 companies in 2001, while during the same time Germany had 365 specialist biotech companies. Dr Jiansheng Du, DTI  International Technology Promoter referring to Ernst & Young Report pointed out that the UK has about 154 products in the pipeline. Out of these, 49 are in the pre-clinical phase, 39 in Phase-I, 45 in Phase-II, 21 in Phase-III. But Germany has a total of just 11. Added Salusbury, â€œThe UK companies account for 43 percent of the products in the pipeline by European public companies. Also 43 percent of new biotechnology drugs in Phase III clinical trials in Europe are from the UK.â€? A range of factors contributes to the UK's strength as location for all types of biotechnology applications. Industry and DTI officials site them as: â€”The combination of excellence in research with the presence of major multinational companies that can place products into world markets. â€”Government annual expenditure on bioscience research is approximately $960 million. Charities such as the Wellcome Trust and the Cancer Research UK provide significant funding. The Wellcome Trust is to invest at least $5.4 billion in the next five years to support biomedical research â€”A knowledgeable investment community, high-caliber patent agents and management consultants, and world class toxicology testing, clinical trials, and other specialist services. â€”A strong and established partnership between the government, industry and the finance community to develop and maintain a supportive climate in which the biotechnology sector can flourish.   Growth converters Du pointed out that R&D is underpinning the biotech growth. The UK alone can lay claim to over 20 Nobel prizes in the life sciences. There were about 46 Nobel Prizes in the last 50 years and since 1901, there were 72. Besides, it also has a very strong entrepreneurial ethos. There were about 70 spinouts between 1994 and 1999. During 1999-2000 alone, there were 199 spinouts. He further added that there has been a spinout per â‚¬13 million spent on R&D. According to experts, the UK researchers are among the most prolific in the world, producing 16 papers per $1 million of research funding. Total spending on research and development by the UK biotechnology companies in 2002 amounted to £1.25 billion, more than the rest of Europe combined together, according to independent research by Critical I. Since 1994, there has been an increase in the importance given to policies to encourage collaborations between university and industry and to commercialize research in biotechnology. The UK has witnessed an increase in all commercialization activities between 1995-96 and 1999-2000. Informed Salusbury, â€œThe universities of Cambridge, Oxford and London form the hub of one of the few world-class high-technology clusters that competes with the US. Edinburgh has become the center of an emerging agricultural biotechnology cluster that is home to 85 companies such as Ardana. In Dundee, Cyclacel is developing new types of cancer treatments based on Professor Sir David Lane's discovery of p53, a key gene involved in tumor suppression. Clusters are also growing in Kent, York and Manchester.â€? Spinout of companies from the universities in the UK has been a very important activity. University of Cambridge and University of Oxford have led the trend. In fact, University of Oxford has a very unique model. The University has a wholly-owned subsidiary, Isis Innovation Ltd. It is the technology transfer company of the University, commercializing the research generated by the University researchers and owned by the University. It has helped in the formation of more than 30 University spinout companies. Pre 1997, there were 9-10 spinouts. "It was about a spinout every four years then, now it's eight companies a year," explained Dr Tim Cook, managing director, Isis Innovation. "The research income in medical sciences and life and environmental sciences is £83.2 million and £21.8 million, respectively, accounting for 56 percent and 15 percent of the total income. So we have focused to help those researchers who wish to commercialize the results of their research." The UK has an active investment community and has Europe's largest venture capital sector. In the first half of 2001, the UK Biotech companies raised about $256 million of venture capital funds (39 percent of the UK total). In 2001, 95 percent of Europe's biotechnology companies were privately owned. A number of VC companies in the UK specialize in biotechnology and related investments.   Regulations The role of the government has been primarily to keep the regulations simple. Said Young, â€œThe UK government is committed to minimizing the regulatory burdens on the industry, as well as ensuring that human health and safety are protected.â€? Is there a biotech policy? Said Young, â€œThe government works with the biotech industry. We do not have a written down policy. But there are regulations and measures to facilitate the growth of biosciences. The BIGT was set up to identify any barriers that could significantly holdback the growth of the biosciences sector and make recommendations to overcome the obstacles. Its report to the government was published in November 2003. The government is considering its response to the report.â€? Informed Laura Gilbert, head of public affairs, BIA, â€œThe UK is working in Europe to ensure that regulations and other measures affecting the development of biotechnology take full account of the concerns of business.â€? Britain has practical and effective arrangements in place for clearance of products, such as novel foods, through the Advisory Committee on Novel Foods and Processes (ACNFP) and diagnostics, through the Medicines and Healthcare products Regulatory Agency (MHRA). The Gene Therapy Advisory Committee (GTAC) has taken a pragmatic and sensible approach to controls on gene therapy. The Advisory Committee on Releases to the Environment (ACRE) provides advice on GMO consents. Following a review of the regulatory system, the Government has established the Agriculture and Environment Biotechnology Commission (AEBC) to consult widely on biotechnology issues and the environment. The Human Genetics Commission (HGC) has been set up to look at genetic technologies and their impact on humans, providing strategic advice to the Government. The Food Standards Agency (FSA) has taken responsibility for the assessment of GM foods and the development of new policies. Further, The European Medicines Evaluation Agency (EMEA) is responsible for fast-track approval of biotechnology-derived pharmaceutical and veterinary products throughout Europe. It provides a single EU-wide licence valid in all member states. The UK (MHRA) provides approval of other medicinal products and has a strong international reputation. The UK is governed by the Embryology Act together with the Human Fertilization (Research Purposes) Regulations 2001.   Government role The DTI plays a very important role in the growth of biotech. â€œWithin the DTI, there is a Bioscience Unit. This aims to increase the competitiveness of the UK biotech sector by exploiting the science base and influencing all the conditions necessary for the development of the sector,â€? informed Young. It also offers a range of support to the UK biotech sector through programmes like Harnessing Genomics, The Biotechnology Exploitation Platform (BEP) Challenge, BIO-WISE, grant for R&D, the Link scheme, Eureka, The EU Sixth Framework Programe (FP6), Enterprise Fund, and The New and Renewable Energy Programme. The government has introduced R&D tax credit mechanism under which all small companies investing in R&D in the UK are entitled to a deduction from their taxable income of 50 percent on current spending on qualifying R&D, on top of the normal 100 percent deduction. Large companies are entitled to 50 percent deduction. Besides, the DTI has co-funded Genetic Knowledge parks with the Department of Health (DH). â€œWe have also supported the National Biomanufacturing Center to be built in the North West,â€? said Young. This is to improve the availability of biomanufacturing capacity to biotechnology businesses particularly at the development and clinical trials stage. International partnerships have been a very important consideration for the UK Pharma and the biotech.   India angle In recent years, there have been collaborations between the UK and the Indian pharmaceutical industries. â€œWe saw Dr Reddy's acquiring a British generic manufacturer BMS Laboratories in 2002. There has been an agreement between Ranbaxy and GSK to collaborate,â€? informed Sargent. Where does India figure in the mind of the UK industry? There are diverse views. While several people at the DTI perceive that IPR is an issue and this is the reason why the UK companies have shied away from India. But said Salusbury, â€œIndia is interesting. There are a large number of like sized companies. This is important as in the past it has been observed that there were problems with unmatched size partnerships. And India can offer the right match. India is also developing its biotech. I believe it is an issue of ignorance and unfamiliarity.â€? Salusbury's team has done a report on the Indian biotech industry and it is in the final stages of compilation. Some members of the industry also opine that India and the UK biotech companies can collaborate. According to Dr Mark Payton, business development manager, Oxxon Pharmaccines, a couple of Indian companies have shown interest to manufacture our products. Oxxon Pharmaccines Ltd is a biotechnology company developing novel immunotherapeutics, specifically therapeutic vaccines (pharmaccines), based on its unique PrimeBoost technologies for the treatment of chronic infectious diseases and cancer. According to Payton, by going to India, they will be able to outsource their manufacturing. This would not only reduce their costs but can also bring their products quickly to the market place. Dr Peter Wrighton-Smith, CEO, Oxford Immunotec, a clinical diagnostics company, which develops and sells clinical diagnostic products, based on its patented CLINISPOT technology, said, â€œIndia is a good market for clinical diagnostics.â€? Going there will be good for us. Kevin Bazley, manager, business growth team, Scottish Enterprise, shared some very interesting facts. A lot of Indian students are coming to the UK. Abertay Dundee University offers a course in MSc in Biotechnology and BioInformatics. There are 65 students in the course and 58 of them are from India. He believes these students may have been sponsored by the leading corporates from India. Further, he suggests the UK companies and universities can partner for addressing the tropical diseases. Certainly, there has been an increased interest between the two countries.   Future road So where is the UK biotech headed? Experts believe that the market is expected to reach $8.5 billion in 2005. Clearly, biotech is a priority for many of the UK's Regional Development Agencies. As a result of focused efforts several niches are emerging. For example biomanufacturing is growing in North West England; stem cells, bioinformatics, and biomanufacturing are growing in North East England; tissue engineering, medical devices and plant sciences are growing in Yorkshire and Humber. And when BGIT report recommendations will be adopted, the UK will emerge out the depressed phase of slow growth currently. â€”Ch. Srinivas Rao   DTI Programmes Harnessing Genomics It is a $41 million programme to help businesses take up rapidly developing biotechnology/genomics science and apply it in new ranges of commercial products, processes and services. The Biotechnology Exploitation Platform (BEP) Challenge This is a $25 million programme (including pilot) with DTI support of nearly $14 million. It is a competition (now closed to new proposals) for grants for publicly funded science base institutions aimed at encouraging them to collaborate through the formation of consortia (the BEPs) with complementary bioscience research to better manage and exploit the results of that research. BIO-WISE It is a $21 million programme, set up in 1999, which aims to improve the competitiveness of UK industry through the use of biotechnology and support the development of the UK biotechnology supplier industry. Grant for R&D This DTI initiative provides grants to help individuals and small and medium-sized businesses to review their use of technology, access technology and research and development, and develop technologically innovative products and processes (which includes technology reviews, technology studies, micro projects, feasibility studies, development projects, and exceptional development projects). The LINK Scheme It is a well-established framework for collaboration between the public and private sectors in support of science and technology in areas of strategic importance to the national economy. Currently, DTI supports around 30 biotechnology projects through LINK programmes. Government Departments and Research Councils provide up to 50 percent of the eligible costs of a project, with the balance coming from industry. EUREKA This aims to improve industrial competitiveness and exploitation of advanced technologies through partnerships between companies and organizations in EUREKA member states. Projects are industry-led and pre-competitive, and offer companies, particularly SMEs, an established platform on which to seek new partners from the European bioscience community. The EU Sixth Framework Programme (FP6) It is the European Community Framework Programme for research, technological development and demonstration designed to fund and promote research. With a budget of â‚¬17.5 billion for the years 2002-2006, it represents about 4 to 5 per cent of the overall expenditure on Research Technology Development (RTD) in the EU member states. The bulk of research is separated into seven key priority areas. Biotechnology falls into â€œLife sciences, Genomics and Biotechnology for Healthâ€? which integrates post-genomic research into the more established biomedical and bio technical approaches. This research has been allocated â‚¬2255 million. Enterprise Fund DTI provides the Small Firms Loan Guarantee Fund to help small firms with viable business proposals to obtain finance if conventional finance cannot be found. The Enterprise Fund also includes the establishment of Regional Venture Capital Funds (via RDAs) and the UK High Technology Fund. The New and Renewable Energy Programme Currently managed by Future Energy Solutions, the DTI scheme supports work on the production and utilization of fuels from biomass and biological wastes.   Research Councils In the UK there are seven Research Councils charged with the responsibility for supporting research and training in a range of scientific disciplines. Of that, three are involved in biotechnology, each one possesses its own research institutes carrying out research related to biotechnology. The Councils promote a programme of fundamental research and collaboration between academia and industry. Biotechnology and Biological Sciences Research Council (BBSRC) With an annual budget of $243 million (BBSRC Annual Report, 2003), BBSRC is Britain's leading funding agency for academic research and training in the biosciences, at universities and institutes throughout the UK. BBSRC has the responsibility of optimizing the exploitation of the research and training programme supported by the Council. Medical Research Council (MRC) With a total budget of $480 million, the MRC is funded primarily by the Government (Office of Science and Technology). In 2000-01 the MRC received $512 million in government funding and with these funds the MRC supports a substantial amount of fundamental researchâ€”both in its own establishments and universitiesâ€”which underpins those aspects of biotechnology which are of relevance to human healthcare, such as work in genetic and protein engineering, monoclonal antibodies, gene therapy and infectious microorganisms. Whilst the MRC does not itself normally finance the work on the development of specific products, the Council's policy is to foster collaboration between its establishment and industry in order to promote the transfer of industrially relevant skills and technologies, the commercial exploitation of Council inventions, and development of new products in healthcare. Natural Environment Research Council (NERC) NERC has a distinctive role to play in biotechnology through its responsibility for, and expertise in, research on the ecology and variation in microbes, plants and animals in the natural environment.   ]]> <![CDATA[Premier business destination]]> https://biospectrumindia.com/news/95/2182/premier-business-destination.html https://biospectrumindia.com/news/95/2182/premier-business-destination.html Wed, 17 Mar 2004 16:57:00 +0530 South East Premier business destination Led by Oxford, South East of England is home to a myriad list of homegrown companies. From the South East region, there are 22 UK biotechnology companies listed on the London Stock Exchange with a combined market value of over £7.25 billion. What's more is that there are an estimated 270 bioscience organizations within the region. â€œNumerically, the region is very strong in the biosciences sector.  Several leading players like Shire Pharmaceuticals, Celltech, and Amersham Biosciences have their world headquarters. In fact, we have companies from across the globe with their foothold here. From the US, we have Genzyme, Biogen,  Abbott Murex, Charles River, Vertex, and Serologicals, among others. From Japan come Takeda, Yamaouchi, Kowa, etc. European majors Qiagen and Evotec OAI are also here,â€? informed Clare Robinson, sector manager, pharma, bio & healthcare, SEEDA. Indeed, the region employees 28,600 employees in over 650 establishments in natural sciences R&D. It is renowned for its excellence in research in areas such as bioinformatics, chromobiology, environmental technology, fermentation technology, human nutrition, neurodegenerative diseases, pharmacogenetics, psychopharmacology, toxicology, viral diseases etc. The region is home to 25 institutions offering life sciences related courses and about 60 active university departments which provide ideal platform for research  partnerships. Oxford University is renowned for genetics, immunocology, cardiovascular and toxicology. Besides, it has a range of institutes like the Wellcome Trust for Human Genetics, which undertakes genetics research and the Sir William Dunn School of Pathology, famous for penicillin work. The School of Biological Sciences at the University of Sussex, especially the Neuroscience center and the Genome Damage and Stability research center are among the top notch centers. The University of Kent's Department of  Biosciences has one of the highest research budgets. The list is quite huge. This is the reason why several companies are located in the region. Besides there is ISIS Innovation, a subsidiary company of the University of Oxford, which help in technology transfers and spinouts from the Oxford University. The life sciences companies are spread across the region, but again there are sub-clusters. â€œThe Oxfordshire cluster is one of the most successful bioscience clusters. There are over 120 biotech companies, labs, and research organizations in these clusters,â€? informed Lin Bateson of Oxfordshire Bioscience Network. She added that companies like Powderject Pharmaceuticals, Oxford Biomedica, British Biotech, and Oxford Glycosciences have exploited the research at the Oxford University and spun out to become big. Kent has a dispersed cluster and there are companies with large manufacturing bases in this region like Pfizer, Genzyme, GSK, and Abbott. Even research work is carried out by some in their units. This region is host to several science parks. Universities like the Oxford and the Surrey have affiliated science parks. Besides these other successful parks include Chilworth Research Centre (Hampshire), Sittingbourne Research Center (Kent), Reading Innovation Center (Berkshire), etc. Promoting the South East's biotechnology capabilities in the global markets and providing the right access is South East England Bio (seebio), a partnership between the SEEDA and the regions bio-network organizations: Southern Bioscience, Oxfordshire Bioscience network, and Life sciences for Business in Kent. ]]> <![CDATA[Genuine center of excellence]]> https://biospectrumindia.com/news/95/2404/genuine-center-of-excellence.html https://biospectrumindia.com/news/95/2404/genuine-center-of-excellence.html Wed, 17 Mar 2004 16:56:00 +0530 Scotland Genuine center of excellence The birth of Dolly, the sheep, elevated the profile of Scottish biotech in a big way. This is one region where scientists are very respected and biotechnology is well spread and understood. A lot has been done by the Scottish Enterprise to promote biotech. Kevin Bazley, deputy director, Scottish Enterprise Biotechnology Group, said, â€œWe operate the Taxi Driver test.â€? The taxi drivers know and understand biotech. In fact, this is the region, which has maturity for the biotech business. Scottish Enterprise is Scotland's main economic development agency, funded by the Scottish Executive. Scottish Enterprise has a life sciences team to help people in the sector, access finance to start and grow businesses, get business support, establish international connections, improve skills, and strengthen networks. Its international arm is Scottish Development International, which is jointly funded by Enterprise and the Scottish government, looks at inspiring international companies to tap the Scottish potential. In deed, the Enterprise is one of the earliest regional developmental agencies to have focused on life sciences as early as in 1994. Besides promotion, the agency also has funded in companies, which again is unique. So where is the biotech sector located? Informed Lezley Ward, executive, Trade-Life sciences, â€œDundee, Edinburgh, and Glasgow form the research triangle of Scotland. According to Bazley, â€œThere are five lead markets in the sector: therapeutics, veterinary, agriculture, environmental, and diagnostics.â€? The companies from this region are spread across various areas of biotechnology. These  include drug discovery, biomanufacturing, bioinformatics/genomics/proteomics, clinical/non clinical research, regulatory compliance, contract research, and product development. Added Bazley, â€œSince 1999, the number of companies in the sector has grown by an average of 28 percent every year. (The European average is 15 per cent.) In 2002, 13 new core life sciences companies were formed in Scotland. There are over 420 organizations in Scotland's life sciences community, employing over 25,000 people. Scotland is now home to 20 percent of the UK's life sciences companies,â€? informed Bazley. Over 50 academic institutions and 80 companies are engaged in drug discovery. There are more than 100 Scottish-based medical devices companies. Scotland has 50 percent of the UK industry's manufacturing facilities. There are over 200 Scottish-based contract research organizations. Scottish researchers work in many areas, from developing new therapies for cancer and heart disease, through to understanding the causes of Alzheimer's disease. For example Axis Shield works in cardiovascular risk, infectious disease, and autoimmune diagnostics; Biovation on human mAbs; Cyclacel in novel cancer therapeutics; Haptogen in antibody engineering in drug discovery; Q-One Biotech in viral safety testing (acquired by Bioreliance). These are just few examples. Added Bazley, â€œScotland has more clinical trials organizations than elsewhere in the UK. We also have a strong base of medical diagnostics companies. Availability of skilled resources has been the major reason for the development of the sector. Education is imparted across the full range of life science and medical disciplines. Fueling all this is the rich education and research base. â€œIn 1470, Scotland witnessed the first medical surgery, but it was after the birth of Dolly, the world's first cloned sheep, in Scotland in 1996, Scotland got recognized,â€? told Bazley. It has 50 odd university departments and institutes doing biotech research. Leading cancer research is happening at Cancer Research UK Beatson Laboratories, Glasgow, and Dundee University. Edinburgh has a large number of clinical scientists and researchers. The Roslin Institute, where Dolly was born, is the most famous one in the region and is involved in genomics and bioinformatics. Clearly on strength of all these, Scotland is moving up the value chain.  It is there from discovery to development to delivery to manufacture. It would also lead the stem cell research activity. ]]> <![CDATA[Bright Island]]> https://biospectrumindia.com/news/95/1926/bright-island.html https://biospectrumindia.com/news/95/1926/bright-island.html Wed, 17 Mar 2004 16:42:00 +0530 Northern Ireland Bright Island A hot spot for new start-ups. The last few years have seen an increase in the number of employees and sales in the region. The reason: excellent science coupled with the focus to translate good ideas into products. There has been stress to spend more on science. It is estimated that about â‚¬1.2 billion will go into Irish science by 2007, with a strong focus on biotechnology, information technology, and communication technology. Several biomedical institutions have been beneficiary to these investments. For example, Dublin Molecular Medicine Center got close to â‚¬27 million money already. The Center is a partnership between biomedical departments at Trinity College and University College Dublin, and the Royal College of Surgeons. According to some available information, about â‚¬320 million has been earmarked for biotech. Development agencies in the region, Enterprise Ireland and Invest Northern Ireland, have been leading from the front to promote biotechnology throughout the island. Enterprise Ireland's biotechnology strategy is focused in four areas: start-ups, venture capital, applied research, and incubators. Also an Irish Bioscience Venture Capital Fund has been established. Invest Northern Island considers biotechnology, pharmaceuticals, clinical trials, nanotechnology, medical devices, and biomaterials are the key areas of growth. . University of Ulster and Queen's University are the main drivers of research in the region. Ulster University has a £14.5 million Center for Molecular Bioscience. The University's Science Innovation Center and Science Parks is home to over 25 companies. Wyeth Biopharma Campus is a major development in Ireland. Wyeth is constructing a billion-dollar facility for protein manufacture and research, at Grange Castle, north of Dublin. Cover 1.2 million square feet, it is being claimed as the largest such facility in the world. The Northern Ireland is in the making of what is touted as the equivalent of Switzerland (famous for watches) in the Biotech. ]]> <![CDATA[Research Fineness]]> https://biospectrumindia.com/news/95/1646/research-fineness.html https://biospectrumindia.com/news/95/1646/research-fineness.html Wed, 17 Mar 2004 16:41:00 +0530 The North East of England is home to R&D. This region is focused on creating a world-class center in R&D and commercialization of R&D in Life Sciences. A strong broad-based bio-scientific research portfolio exists in the North East with activities spanning medical, agricultural and environmental areas. In particular, the major strengths in the North East Life Sciences sector have been identified in oncology, ageing and health, genetics and stem cell research, and plant biotechnology. The Centre of Excellence in Life Sciences (CELS) is tasked with identifying key areas of regional scientific excellence and those platform technologies, which will strengthen their development. At the heart of the life sciences cluster in the North East lies one of the most successful Millennium projects in the UK, £70 million International Centre for Life. It has low-cost incubator units for use by university spin out companies and start-up projects alike. Further, The Institute for Human Genetics is also located at the site, which is the largest of its kind in Europe with over 100 geneticists researching into genetically related diseases. Newcastle University is one of the UK's leading biomedical schools. It is one of the only three research establishments to have been given official approval by the UK government to take forward its work in the area of Stem Cell research.  Newcastle also has the leading health informatics research center, the Sowerby Centre for Health Informatics (SCHIN). The Institute for Ageing and Health is the UK's largest research grouping of basic, clinical and social scientists in the field. Durham University is home to a Centre of Excellence in Biochemistry and Genetic Engineering. The University of Sunderland has the largest school for pharmacy in the UK. The Northern Genetics Knowledge Park was awarded to the Region in January 2002, which will create a new laboratory center, providing an interface between the Institutes of Human Genetics, Cancer Research and Ageing and Health. The unifying theme will be genome instability. These centers of excellence have been some of the main driving forces for several multinational companies like Glaxo SmithKline, Merck Sharp and Dohme, Pharmacia and Sanofi-Synthelabo to have their base within the region. Avecia, a world leader in biologics manufacturing, is investing £70million to build one of the world's most advanced biologics medicines manufacturing facilities in Billingham, Tees Valley. ]]> <![CDATA[A pedigree]]> https://biospectrumindia.com/news/95/2386/a-pedigree.html https://biospectrumindia.com/news/95/2386/a-pedigree.html Wed, 17 Mar 2004 16:36:00 +0530 Cambridge and East of England are the premier locations in Europe for life sciences. Cambridge undoubtedly is the Mecca of biotech not just in the UK, but the entire Europe. It is home to several discoveries. There have been 14 Nobel Prize winners. The discovery of the double helix structure of DNA by Crick and Watson to the Human Genome project at the Wellcome Trust Sanger Centre, there has been cutting edge research work. According to Jeanette Walker, business development manager, ERBI Limited, the industrial biotechnology cluster within Cambridge emerged in the early 1980s in a hi-tech environment created by existing electronics and computing industries. Initial companies were founded on the Cambridge Science Park (owned by Trinity College, University of Cambridge), which itself was built to attract computing companies. There after there has been no looking back. For example, Domantis, a venture of Dr Greg Winter, founded in December 2000 has around 12 prospect compounds in development internally. Similarly, Astex Technologies founded in 1999, besides working on structural biology is working on drug discovery for companies. Amedis is sighted as another example. It started as a company predicting the toxicological effects of small molecule drugs, but toward the end of 2002, it announced to develop silicon-based drug molecules. Further companies like Acambis, Celltech, and Cambridge Antibody technology have products on the market and late stage development. There isn't any dearth of doing any case studies. Explained Walker, â€œThe entire region is home to a 180 companies. Almost 55 percent of these develop biopharmaceutical products.â€? Bioscience in the region has been growing on account of availability of research, ventures, and the entrepreneurial culture. Said Walker, â€œThe universities here spinout a large number of companies. In this region, the researchers and venture capitalists get along very well. There is innovation in funding also. Companies here have attracted close £50 million in 2002.â€? There is investment available at all stages. There is â‚¬1 billion of venture capital within the region from companies like 3i, Merlin, Avlar, and NW Brown. These VCs are sufficiently experienced in dealing with the biotech companies. Further the region has 12 bespoke research parks. Additionally there have been developments to build more biology and chemistry labs in parks like Cambourne Research Quarter, Cambridge Research Park and the Babraham Research Campus. To top it the area has over 10 biomedical research institutes including the largest Genome Campus in Europe. It has the world renowned Laboratory of Molecular Biology, which is also dubbed as the â€œNobel Factoryâ€?.  It also houses Europe's largest campus of agbio, plant, food, and microbial science at the Norwich Research Park and the Institute of Agricultural Crop Research, located in Herefordshire is in this region. Besides there are six top universities with research groups in the life sciences. While science and venture caps have been the mainstay of the success of the Cambridge and East of England, organizations like ERBI have helped build the right networks. With 260 odd members, ERBI is the largest regional biotech industry group in the UK and provides the access to this regional cluster. All the life sciences companies. It provides not just access to the research, test, and commercialization of products and services, but also helps the new comers to find space, staff, and the bioconsultants in law, finance, IPR, etc.   Size of the bio-community 185 biotech companies 250 specialist service providers with biotech expertise 30 research institutes and universities 20 multi-nationals in pharmaceuticals, agbio and food 4 leading hospitals involved in research and working with biotech ... and over 100 other organizations which take a strong interest in the bio-community Other facts 5 quoted companies by the end of 1995 (Market cap. was £400m) 300% growth in quoted companies by 2000 (Market cap. became £7 billion) 20% of Europe's publicly traded companies Home to half of the UK's top 15 LSE quoted biotech companies Home to 25% of Europe's top 50 publicly quoted companies £1bn of VC funds available from companies located within the region In 2002, there was a base level of nearly 1,100,000 sq.ft occupied by lab-based biotechnology businesses in Cambridgeshire alone. (With 250,000 sq.ft under construction). Growth over the past 6 years has varied between 7-24% per annum with an overall growth in that period of approximately 115% (i.e., approximately 13% per annum). 29 publicly quoted biotech companies, 17 UK, 8 US, 2 Canadian and 2 European (excluding pharmaceutical companies) Employment 10,000 people employed directly related to biotechnology business (2002 estimate based on survey - asking numbers of people employed and % of business which is biotech and includes service providers) 25,000 people employed in life sciences 20,000 people employed by ERBI membership Research 13 Nobel Prize winners in medicine and chemistry since Crick and Watson (2 in 2002) Over 3,500 students and 350 research groups within life sciences International companies Amgen, Genzyme, Gilead Sciences, US biotech companies all have operations in the region 20% of biotech companies have a foreign parent GlaxoSmithKline, Merck Sharpe and Dohme operate several major research establishments in the region Biotech market areas - products and services 55% develop (bio) pharmaceutical products 10% develop contract or clinical services 8% develop human healthcare diagnostic 5% involved with agbio development 7% develop biotech instrumentation and equipment 15% in other areas, e.g. informatics, food, speciality reagents, etc ]]> <![CDATA[A Natural Cluster]]> https://biospectrumindia.com/news/95/2517/a-natural-cluster.html https://biospectrumindia.com/news/95/2517/a-natural-cluster.html Wed, 17 Mar 2004 16:36:00 +0530 London A Natural Cluster With over 100 biotech companies, 28 research institutes, and millions of public money, London is a natural home to the thriving life sciences sector. There are over 28 universities and institutions in London undertaking life sciences research and teaching. About 1,350 academic research staff was estimated as working in top rated biological sciences and clinical departments in 2001. There are 55 odd hospitals, trusts, and medical schools in the capital.  Spending on biotechnology related research in London is around $430 million annually. Further, 70 percent of National Health Service (NHS) research (which totals $610 million) is spent in London. This explains why the London biotechnology cluster forms a significant part of the largest concentration of biotechnology companies in Europe. David Hodgson, business development manager Japan, London First Centre, explained, â€œThere are currently 82 odd biotech companies in London, which represents an increase of over 40 percent in the last two years. The majority of these companies are university spinouts.â€? UCL and Imperial College School of Medicine are the two largest medical schools and Imperial College is believed to â€œspin-outâ€? on average one biotech company every month. DTI also extends its support to the UCL spinouts through training vouchers for small and medium sized enterprises in biomanufacturing. About $20 million has been invested in a unique manufacturing research and training facility. London attracts high levels of public and private funding. There is another interesting trend too. Some of these spinouts are virtual companies. The life sciences sector in London is focused on the development of therapeutics. Also the Capital has been a major center for clinical trials. There are about 50 clinical research organizations covering all specialities here.  â€œIt is estimated that 60 percent Europe's clinical trials are done in the UK,â€? explained Hodgson. And London is the headquarters for the European Medicines Evaluation Agency. The Agency facilitates product approvals across Europe without going through individual country assessments. Moreover, The Medical Research Council (MRC) is headquartered in London and funds government biomedical research. The MRC supports the renowned National Institute for Medical Research (the MRC's largest institute). It is also in the process of establishing a UK stem cell bank. This bank will hold all adult and embryonic stem cell lines generated in the UK. The Laboratory of the Government Chemist (LGC) is a leading provider of chemical analysis and DNA testing services. There has been a lot of stress and expertise in stem cell research. For example, the Imperial College Tissue Engineering and Regenerative Medicine Centre, headed up by Prof. Julia Polak, has recently converted embryonic stem cells from mice into the specialized cells needed for gas exchange in the lungs. This is being repeated with human cells, with the eventual prospect of regenerating damaged lung tissue and even creating whole lungs by bioengineering. Also scientists at King's College London were granted one of the first two licences to produce human embryonic stem cell lines. This was the first time scientists had been allowed to work on developing embryonic stem cells for research as all previous embryo work had been for fertility treatment or other medical therapy. The licence was granted to three King's College researchers: Dr Stephen Minger, Dr Susan Pickering and Professor Peter Braude. â€œThe areas of focus by the biotech companies located in London are widespread. But cancer therapies are the most prevalent area. Other areas range from inflammatory diseases to bioinformatics to new CNS and tissue engineering,â€? elaborated Hodgson. Life Sciences Company Funding <£1 million 18 companies (3%) £1-5 million 6 companies  (6%) £5.1-10 million 3 companies (13%) £10.1-20 million 3 companies (22%) £20.1-35 million 4 companies (56%) Source: London Life Sciences Strategy and Action Plan. LDA surveyed 55 of the 82 core biotech companies and these figures are of that survey.   ]]> <![CDATA[Biotech Magnet]]> https://biospectrumindia.com/news/95/2484/biotech-magnet.html https://biospectrumindia.com/news/95/2484/biotech-magnet.html Wed, 17 Mar 2004 16:27:00 +0530 The concentration of medical expertise has made the region a magnet for the biotech and pharma companies. The British Midlands has emerged as a focal point for specialized medical technology companies. In recent years, the region has seen an explosion of research and scientific breakthroughs. For instance Magnetic Resonance Imaging (MRI, pioneered at the University of Nottingham) was developed here; so was genetic fingerprinting (discovered at Leicester University). Specialist clusters are springing up across the British Midlands and, currently, there are about 700 medical technology companies employing 16,000 people. Among the world class companies located here are AstraZeneca, Bayer plc, Boots, Sunrise Medical and 3M Laboratories. The British Midlands has witnessed strong research in diagnostics, cell signalling and the causes and treatment of cancer. The British Midlands has been attractive as it is strategically located for easy access to the UK and Europe. As with the other parts of the country, the universities in the region achieve more 1st Class degrees than anywhere else in the UK. For instance, The University of Nottingham is one of the top four research-led institutions in the UK and a member of The Russell Group of Universities. It has a new $14 million Institute of Drug Discovery and a $10 million Institute of Pharmaceutical Sciences. Warwick University, another Russell Group University, renowned for its biological sciences research, has a new $9 million Medical Research Institute linking its research to the clinical skills of doctors at five Midlands' hospitals. The CRC Institute of Cancer Studies at Birmingham University is reputed for cancer genetics, signal transduction, viral oncology and immunology, cancer gene and immunotherapy and cancer clinical trials Aston University, which scores the highest rating for its Neurosciences Research Institute, is opening a new $12.8 Million Academy of Life Science. Key activities will include cornea and refractive surgery, brain imaging and human myopia. The Wellcome Trust Clinical Research Centre at Queen Elizabeth Hospital in Birmingham is part of a $25 million initiative to strengthen clinical research in the UK's National Health Service. Besides, The UK Human Tissue Bank, based at De Montfort University in Leicester, provides non-transplantable human tissue to the UK research community. Leicester De Montfort is the only UK university to hold such a resource. This expertise is supported by BioCity Nottingham, a bioscience innovation and incubation center, the largest of its kind in the UK and one of the largest in Europe. There are also few other networks of dedicated science parks and incubator parks. It has been a good base for the medical devices too. For companies involved in the supply and manufacturing of medical equipment, the British Midlands offers ideal trading conditions. Raw materials, components and specialized services can all be found hereâ€”from metal fabrication and plastic injection molding to specialized engineering and packaging. Telemedicine was pioneered in the British Midlands and one of the region's many successful foreign investors, Kodak, is currently developing a software system for use in hospitals and remote locations. Companies from across the medical equipment sector have made their home here, including manufacturers of disability and rehabilitation equipment, ophthalmic technology, biomaterials and active implants. In addition, there are some specific benefits for companies in this sector: At Loughborough University, researchers have developed an electronic system that allows signals from medical monitoring equipment to be transmitted across the mobile phone network. Keele University also concentrates in the fields of medical devices, biocompatible materials and materials science. The Medical Devices Faraday Partnership brings together 6 UK universities working alongside industrial organizations to develop new medical and surgical devices. ]]> <![CDATA[Executive Summary of BIGT Report]]> https://biospectrumindia.com/news/95/2935/executive-summary-of-bigt-report.html https://biospectrumindia.com/news/95/2935/executive-summary-of-bigt-report.html Wed, 17 Mar 2004 16:20:00 +0530 This report is the result of a seven-month project launched by Lord Sainsbury, Parliamentary Under Secretary of State for Science and Innovation, and Lord Hunt, then a Minister at the Department of Health, in partnership with the BioIndustry Association (BIA). The mandate of the BIGT was to take a strategic approach to the future of the bioscience industry. The Chairman is Sir David Cooksey (Advent Venture Partners), a leading UK venture capitalist. The task of BIGT has been to identify any barriers that could significantly hold back the growth of bioscience in the UK. The BIGT's vision is that by 2015 the UK will have secured its position as a global leader in bioscience. To secure this position, the UK must create: A diverse, self-sustaining bioscience sector, with a core of large, profitable, world-class companies. The most efficient and effective setting for conducting clinical trials in the world. A healthcare system, regulatory regime and business environment that support bioscience innovation. There are two significant benefits for the UK in achieving this vision: Improved national health, through improved clinical performance and early access to innovative medicine. Increased national wealth: enhanced Gross Domestic Product by maintaining and supporting a high growth, high margin, high value-added, knowledge-based industry.   BIGT Recommendations Build a mutually advantageous collaboration between the NHS and industry for patient benefit through the creation of a National Clinical Trials Agency (NCTA). The NCTA, sponsored by the Department of Health (DH) in collaboration with Research Councils UK, should support excellence in clinical trials and clinical research within the NHS. Create a public and regulatory environment supportive of innovation. This includes improving regulatory support for the development, approval and use of innovative medicines in the UK, through effective collaboration between industry, regulatory agencies and Government. Ensure sufficient and appropriate funding is available. This includes supporting measures to improve the liquidity of bioscience companies, through adjusting pre-emption rights and corporate venturing, and investing in the bridge between idea generation and commercial financing. Build a strong bioprocessing sub-sector, through the creation of a network of bioprocessing centers of excellence across the UK. These centers would deliver skilled personnel, develop leading edge research and promote the UK as a target for inward investment. Develop, attract and retain a high quality scientific and managerial talent base, through two new programmes to support dual, interdisciplinary education essential to the bioscience sector. Making it happen: Create the Bioscience Leadership Council (BLC) composed of six industry representatives and six strategic stakeholders. The BLC will take responsibility for implementing and building on the BIGT recommendations and will provide a forum for Government and industry to work together to develop a successful bioscience industry. ]]> <![CDATA[Soundbytes]]> https://biospectrumindia.com/news/95/6773/soundbytes.html https://biospectrumindia.com/news/95/6773/soundbytes.html Thu, 11 Mar 2004 19:23:00 +0530 p ALIGN="left">"Dr Takashi Yohkaichiya President, Japanese Association of Pharmaceutical Medicine & Sr Executive VP & Chief Medical Officer, Shin Nippon Biomedical Laboratories Ltd, Japan This is the first time I have come to India. I am very impressed with what I have seen. I am looking at the possibility of putting up a facility here. Dr Anwar Nasim Advisor Science, COMSTECH Secretariat, Pakistan Pakistan is not as strong as India in vaccines. I see a lot of collaboration potential in this area between the two countries. G Michael Alder MD, Redmont Venture Partners Inc & Executive Director Biotechnology Association of Alabama, USA My perception of India has changed considerably after coming here. I no longer see India as I see Thailand, Malaysia, China or any other SouthEast Asian country. Dr Santosh K Mishra Executive Director, BioInformatics Institute, Singapore India has a great strength in IT and making huge strides in bioinformatics is just the next logical step. Govindaluri Anand Associate Director, Investments, Temasek Holdings, Singapore We are already investors in some of the companies here and I am scouting for more investment opportunities. I see a lot of potential in Hyderabad in the pharma biotech. Dr Pravin Kini MD & CSO, CytoGenomics Inc, Chesterfied, USA It is a good platform for networking except that three-days is a way too long for any event. It should be a one-day event. Dr Krishna Menon COO, Kard Scientific, Cambridge, USA I am glad that I am here. It has been a very productive event in terms of networking and getting to know the biotechnology industry in India. Dr Vasudeo Ginde MD, iGate Clinical Research International, Mumbai, India I would say we need to be extremely quality conscious while taking advantage of this big opportunity of clinical trials. The cost of failing on that count will be very high. Let us not fail even once. " ]]> <![CDATA[New Entrants in Genome Valley]]> https://biospectrumindia.com/news/95/2074/new-entrants-in-genome-valley.html https://biospectrumindia.com/news/95/2074/new-entrants-in-genome-valley.html Thu, 11 Mar 2004 19:22:00 +0530 Over 100 biotech companies are located in Genome Valley, India's first state-of-the-art biotech cluster. Good infrastructure, easy accessibility, business friendly policies and other unique benefits are attracting many new companies to establish their units in the SP Biotech Park and the ICICI Park in Genome valley. Presently 17 companies have taken space in the SP Park, while in the ICICI Knowledge Park phase one is fully occupied, phase two is 90 percent booked and phase three is in the planning stage. A bird's eye view of some new companies setting foot in Genome Valley. Sigma-Aldrich Corporation Sigma-Aldrich Corporation, the US-based $1.2-billion leading life sciences company, has signed a letter of intent to acquire about 10 acres of land at the ICICI Knowledge Park in Hyderabad. According to JaiNagarkatti, president, Sigma-Aldrich Scientific Research, the company plans to establish a laboratory facility at the knowledge park which at full capacity will employ between 70 to 80 chemists. Initially the company plans to: i. Offer contract research services on a full time equivalent basis to the pharmaceutical and bio pharma customers. ii. Conduct process development and optimization of some of our existing products. iii. Synthesize small molecules used in drug discovery. iv. Small scale synthesis of organic molecules used in research and development Since establishing a liaison office in 1992, Sigma-Aldrich has continued to expand its operations in India. "We currently have a warehouse and distribution facility at our Indian subsidiary in Bangalore to provide world-class service to researchers in India. We are excited about the opportunity to further expand our presence in India which is a logical progression of our commitment to the region. The selection of the ICICI Park from the many suitable alternatives available in the country was based on the support from the business friendly government of Andhra Pradesh, fully developed infrastructure at the park, availability of talented chemists in the region and proximity to some of our key customers" said JaiNagarkatti. Jasmine Biologicals Pvt Ltd The three-year-old Hyderabad-based company in the bio agri space, Jasmine Biologiocals, is expanding its operations into the Genome Valley and has taken one acre plot in SP Biotech Park. Involved in production of microbial products for agriculture, the company would invest Rs 10 crore spread over a period of three years. According to N Chandrasekhar, MD Jasmine Biologicals, the investment in phase one (Rs 3 crore) would largely be in the manufacturing facility. The company which has to its credit bio stimulant "Exodus" and another product "BioSpark" is looking towards boosting the overall plant health by scaling up its manpower to 45 from current 20. "Make biotech a priority area for banks CEO, Shapoorji Pallonji Biotech Park and member of the AP Biotech advisory Board, S Dhawan points out that funding is indeed a major constraint for the biotech industry. How far has the Genome Valley come since 2001? If you look at it in relation to some of the other states in India, we have done very well but if you look at the last three years lot more could have been done. In SP Biotech Park itself out of 17 companies that have blocked land only five have moved ahead with their projects, rest await financial closure. We need to address funding constraints soon otherwise the great biotech take off will take much longer and we may lose the head start. What do you think can be done? I don't think we need to go the VC way for biotechnology at all as most of the projects that are awaiting financial closure are proper full-fledged projects. We need to make biotechnology as the priority area with regard to banking norms, which will solve half the problem right away. Banks have a sectoral limit and an appraising process, both of which are a constraint for this unique industry. It has to be eased off. However, a policy change of that level is a time consuming process. We have moved the suggestion with the state infrastructure authority, which should present it to the state government and then it should be forwarded for approval to the Centre and the respective agencies. We are following it through. Even if it happens in a year or so it is of great help to entrepreneurs caught in bank lending norms. Is that the biggest challenge the biotech industry faces today? Our biggest challenge is to keep the tempo going. Understand and know the direction we are moving in and evaluate ourselves from time to time to get back on the right track. There is no doubt that we can shake the biotechnology field but how soon we can do it is the question and what are the bottlenecks that should be addressed to move it fast.   Vishesh Biotech With a basic investment of Rs 1.5 crore Vishesh Biotech has entered into a three-year agreement with Noida-based Bioinformatics Institute of India to offer courses in bioinformatics and biotech-related disciplines. Coming up in SP Biotech Park in an area of one acre, the institute's business plan also includes offering corporate training in bioinformatics. G Devraj, CEO Vishesh Biotech, is currently looking at establishing the academic wing after which the company will diversify into bioinformatics R&D and consultancy. Vimta Labs Vimta Labs, a player of the closely guarded world of contract research, has taken 10.5 acre in SP Park. According to SP Vasi Reddy, CEO Vimta Labs, the facility will go operational in 2005. The business plan for another of Vasi Reddy's companies, Vimta Specialities Pvt Ltd, will also crystallize by April 2004. It will be co-located in the SP Park. Shakti Bio Systems Shakti Bio Systems, a Mumbai based company has purchased one acre land at the SP Biotech Park. The company is in manufacturing tools/reagents for the high-end research or innovative activities. Jawahar Raja, proprietor Shakti Bio Systems, said that they are setting a facility in the SP Park due to its easy accessibility from the city and the other unique benefits offered. Celgen Biologicals The AP Government is developing a Marine Biotech Park in Visakhapatman modeled on the lines of Shapoorji Pallonji Biotech Park of Genome valley. The land has been identified and the infrastructural facilities are on their way. Celgen Biologicals Pvt Ltd (Celgen), a subsidiary of ABL Biotechnologies, is in the process of establishing India's first facility for the production of the essential fatty acid DHA at Visakhapatnam. It has been one of the first companies to be allotted ten acres of land in the Marine Biotech Park at Visakhapatnam. According to the officials of Celgen, in spite of ABL Biotechnologies operations being based out of Chennai, it has looked at putting up the Celgen project in AP on the basis of development and support in that state. The state of AP is extremely investor friendly as compared to most of the other states owing to the dedicated focus,they added. Celgen focuses at microbial metabolites that have commercial use. It was set with the objective of establishing a global presence in the area of phytopharmaceuticals from original research conducted in various parts of the world, especially India. The technology for this project has been sourced from ABL Biotechnologies. This project would be the first of its kind in India and second in the world for the production of Omega Fatty acids from plant sources. Celgen would be investing about Rs100 crore in this area. It proposes to produce around 100 MT of DHA per annum. Nandita Singh, Cyber Media News Service ]]> <![CDATA["Entrepreneurs should rise tothe biotech opportunity"]]> https://biospectrumindia.com/news/95/2701/entrepreneurs-should-rise-tothe-biotech-opportunity.html https://biospectrumindia.com/news/95/2701/entrepreneurs-should-rise-tothe-biotech-opportunity.html Thu, 11 Mar 2004 18:49:00 +0530 p>Three months away from closing, India's first biotech focused national fund APIDC-VCL has reached a corpus of Rs 81 crore. Sarath Naru, MD APIDC-VCL, is confident that it will cross Rs 100 crore and is quite likely to touch the targeted figure of Rs 150 crore. In an interview with Nandita Singh of CyberMedia News, Naru shares the success so far and APIDC-VC's future plans. How far has the venture fund come since its launch as against your projections? We are pretty pleased with our progress. On the fund raising side the numbers do the talking. We have raised Rs 81 crore and expect to close way above Rs 100 crore. We have also been successful in attracting talent in our core team, which I classify as a big achievement. We have been able to attract N Vaghul of ICICI. He brings with him a wealth of fund management experience. Then we have Dr SM Balasubra-maniyam who has been instrumental in building seven biotech companies in the US. The cross border experience that he brings is of great value in helping the companies we invest in establish. In terms of support and network formation to support and handhold the companies we invest in, we have signed a MoU with CSIR for technology sharing and commercialization. This will allow our portfolio companies to use CSIR facilities. We have also signed a MoU with Administrative Staff College of India (ASCI) to handhold our portfolio companies in business plan building and train the entrepreneurs in business management. Now, we are focusing on deal generation, which involves attracting good proposals. How many companies has APIDC-VC funded so far? We have so far made investment commitments of Rs 14 crore to five companies. Three of them - BioServe Biotechnologies, Genomik Design Pharmaceuticals, Silico Insights - are in various stages of operations and the other two will also start work soon. We will be finalizing another three companies in our next round of funding. Are you concentrating on any specific areas of biotechnology? So far the companies we have funded have primarily been service driven and have all been US-India ventures. Now we are looking at purely Indian companies and would be delighted to fund companies which are making use of India's rich plant biodiversity say in the area of alternative fuels and those who want to get into contract manufacturing, research and clinical trials. And then of course those in orphan drugs, which nobody wants to take up but nevertheless are of high value to third world countries. In case the project requires more than what we can fund we will go all out to help arrange for additional funding too. What's the total number of proposals you have received so far? 150. Now we would like to focus on attracting good proposals. Given the size of fund we should spend each year, Rs 25 crore in funding, the number of good proposals we receive is not impressive. Here I would like to say entrepreneurs should rise up to take advantage of the opportunity the field offers. What the fund's exit policy like? We are aiming that at least 20 percent of our portfolio companies are listed by the close of the 10-year life of the fund. There is also a provision of third party strategic investor to come in to take the companies further from where we leave. Nandita Singh ]]> <![CDATA["I want AP to be No.1 in biotech"]]> https://biospectrumindia.com/news/95/1783/i-want-ap-to-be-no-1-in-biotech.html https://biospectrumindia.com/news/95/1783/i-want-ap-to-be-no-1-in-biotech.html Thu, 11 Mar 2004 18:48:00 +0530 From the bulk drug capital to a happening biotech destination. This transformation has been catalyzed by the plans, policies and activities initiated by the AP state government under the visionary leadership of the Chief Minister N Chandrababu Naidu, who has nurtured biotech into a booming opportunity in the state. BioSpectrum spoke to Naidu about his plans to boost the biotech industry of the state. Excerpts: What is your vision for Andhra Pradesh with reference to the biotech/life sciences sector? My vision for Andhra Pradesh with reference to biotech and life sciences sector is that a common man should get the benefits of new technologies emerging in these fields. My vision is to provide a disease-free and healthy society by using modern technologies and we are working towards that. For instance, we are establishing International Institute of Life Sciences in Hyderabad, involving the leading biotech and life sciences industries in the State. We are developing centers-of-excellence in different branches of biotechnology viz. for agri and veterinary biotechnology in Acharya NG Ranga University, an agribiotech incubator in ICRISAT, a marine resource development center in association with Andhra Pradesh University and a pharma biotech hub in SP Biotech Park and ICICI Knowledge Park in Genome Valley near Hyderabad. Through such initiatives, we envision developing the state of AP into a biotechnology state of the country. What are the short term and long term strategies to make AP a leader in biotechnology? Andhra Pradesh is the first state in the country to have an exclusive policy for biotechnology in the year 2001. We have announced the policy framework and clear strategies have been worked out. The short term strategies are projecting the strengths of the state, especially the locational advantage of Hyderabad, the strong presence of world class research institutes like CCMB, CDFD and IICT, the availability of a strong pool of trained and scientific manpower, the recently developed ICICI Knowledge Park and SP Biotech Park and a proactive and environment friendly government policy. Among the other strategies to make AP a leader in biotechnology, we have created a brand name called "Genome Valley" and it is widely popular all over the world. We are setting up standards with world class infrastructure and a long term policy for making AP the #1 destination for investments from all over the world. We have created an enabling environment for establishing the biotech industry. We have a single window clearance system for hassle free licensing and approvals. We participate in the international and national exhibitions, conferences and demonstrate our strengths and invite foreign participation and collaboration into Andhra Pradesh. We are liberalizing the labor laws to match the requirements of the industry. Has the State Government identified specific sectors to leverage the existing strengths in AP and leapfrog in biotech? The AP government has been encouraging pharma and biotech sectors to leverage the existing strengths in AP. Vaccines and recombinant DNA products in health care, nutraceuticals and medicinal plant formulations are some of the areas that have been identified as key sectors for growth and long-term development. This apart, contract research and clinical trials also have good promise. What are the Government's plans to provide the latest infrastructure and incubator facilities to biotech entrepreneurs? The Government of Andhra Pradesh has special plans to provide the latest infrastructure in the form of uninterrupted water and electricity supplies to the Biotech and Knowledge Parks. A dedicated sub-station has been erected in the Genome Valley for uninterrupted electricity. Fast track roads have been laid connecting the Genome Valley to other parts of the city. India's first biotech incubator has been established in SP Biotech Park in Genome Valley with an outlay of Rs 22.50 crore in association with DBT and IICT. The incubator offers the latest state-of-the-art facilities for start-up and existing biotech companies and entrepreneurs to try out their new technologies and processes which otherwise would become very difficult to do. The Government is investing huge amounts on all the infrastructure. A National Animal Resource Testing facility is also planned in association with ICMR and National Institutes of Health and an area of 100 acres has been earmarked for this purpose in Genome Valley. An agribiotech incubator is coming up in ICRISAT exclusively for developing new technologies for sustainable agriculture. It will facilitate in producing new crops and varieties for food security and for increasing the nutritional value. What are the fiscal and other incentives available to potential biotech entrepreneurs in AP? There are a number of incentives available to potential entrepreneurs in Andhra Pradesh. There is 25 percent capital subsidy in the cost of the land for the biotech parks, and a rebate in the land cost at the rate of Rs 30,000 for every job created in bioinformatics and other related fields in the parks and a concessional sales tax of only 1 percent as against 12-14 percent outside the park areas. The other incentives available to potential biotech entrepreneurs in AP include provision of water supply and power supply up to the doorstep and excellent roads. A residential accommodation proposal for the personnel working in Genome Valley at concessional rate has also been initiated recently. The government has created an IPR facilitation cell for helping companies in their patenting and other aspects as well as a virtual library and documentation center in ICICI Knowledge Park. What would you like Andhra Pradesh to be related withâ€”meaning what should the recall value of the State be? I want AP to be #1 in biotech. That is our goal. I think we are marching ahead.   ]]> <![CDATA[India will emerge as the outsourcing hub in life sciences]]> https://biospectrumindia.com/news/95/3097/india-will-emerge-as-the-outsourcing-hub-in-life-sciences.html https://biospectrumindia.com/news/95/3097/india-will-emerge-as-the-outsourcing-hub-in-life-sciences.html Thu, 11 Mar 2004 18:42:00 +0530 p>India will emerge as the outsourcing hub in life sciences A biotech policy, 600 sq km genome valley cluster, a venture fund, infrastructure to complement and now BioAsia 2004. BP Acharya, secretary, industries and commerce department, and D Nalini Mohan, additional secretary and director (biotechnology), are driving the state's biotech initiative. Looking back with satisfaction the duo talks about the journey so far and their expectations from BioAsia 2004. How far have we come since 2001 when the state announced its biotech policy? BP Acharya: Biotech Policy announced in 2001 was the foundation stone, we have taken many initiatives in taking the policy further and will continue to do so. Genome Valley is poised to become the largest biotech cluster in Asia. We expect it to be bigger than Singapore in sheer size and variety of biotech activities. And we are working towards that end. Some of our latest initiatives includeâ€”the biotech incubator in SP Park, the 200 acre agri-biotech incubator located in the Icrisat campus, Sun Centre of Excellence in Bioinformatics located in CDFD campus, 218 acre Marine Biotech Park in Visakhapatnam. We are beginning to concentrate on agri and marine biotechnology. And there is no doubt that in time India will emerge as the outsourcing hub of contract research and R&D in life sciences. Shortly, you will see our strength in vaccines manifested in the global arena. And all this is just a beginning. What is the size of investments Genome Valley has attracted so far? BP Acharya: We will close 2004 with at least Rs 2000 crore in investments in the biotech industry. There is a Rs 1000 crore project underway which is likely to fall through as soon as the modalities are completed. Then, Sigma Aldrich is investing Rs 120 crore and the project is in the advanced stage. There are at least three pharma and biotech majors that will announce their R&D units and investments at the event. All Indian pharma majors have their biotech arm and are in the process of setting up a project or evaluating one. Then there is a spin off effect from our participation in Bio India 2003 in Washington. Our facilities have attracted a lot of companies from North Carolina in US, Germany, Switzerland, Australia and they are in various stages of negotiation. A number of NRIs are evaluating projects proposals and have met us in the regard. Then of course we have a partnership on with Malaysia involving resource sharing and industry collaboration. And let us not forget a number of small players who are doing interesting work in biotechnology. Given the long gestation periods for these projects, success stories, the ultimate in furthering an industry, will take time. So how do you propose to keep up the momentum? D Nalini Mohan: We continue with our initiatives. In fact, we have already begun marketing BioAsia 2005. Events like this are usually put on the calendar much in advance given that you are tapping the world participation. We are providing a platform for the Asian countries to showcase their strengths in biotechnology to the world and collaborate wherever possible. The bio business forum will be the annual feature of the event and here our effort is to promote industry collaboration. Moreover, we continue our efforts to support the industry. Let's take just two examples: The Rs 150 crore animal house project which recently rolled out in collaboration with NIH, USA is being led by ICMR and is the largest in India spread over 100 acres. The facility on par with China will be the national resource centre for primate breeding. This itself will give a fillip to the industry in which you need animal testing in different phases of clinical trials. Or take the Life Sciences Institute which is coming up in the Hyderabad University Campus. It is designed to tackle life sciences research with a multi-disciplinary approach. The government has sanctioned Rs 10 crore for the project spread over 35 acres, of this Rs 1 crore has been released this year. What we are doing is creating the right atmosphere for the industry to flourish and success stories won't really be long in coming. We see a big boom in contract research in near future and we will be there. However, we will not stop there. We are promoting biotechnology as a whole not just an arm of biotechnology. BP Acharya: We are going to maintain the head start. We have identified the gap in the residential accommodation in the Genome Valley and have recently allotted 30 acres of land for a world-class residential complex built exclusively for Genome Valley. The land has been taken over by APIIC which is likely to partner with Shapoorji Pallonji for the project. For now, we have christened the project Jeevanpuri. What will be the highlight of Bio Asia 2004? BP Acharya: It is the first one. So, may not be the perfect one but everything that happens at the event is a stepping-stone for us and the biotechnology industry in Asia. The idea is to build a bridge between Asia and the rest of the world. We have also instituted Genome Valley Excellence Award. This year it will be conferred on William J Rutter, the chairman emeritus of Chiron Corporation, US, and Prof MS Swaminathan. Nandita Singh, Cyber Media News Service   ]]> <![CDATA[Bridging the biotech communities]]> https://biospectrumindia.com/news/95/1596/bridging-the-biotech-communities.html https://biospectrumindia.com/news/95/1596/bridging-the-biotech-communities.html Thu, 11 Mar 2004 17:57:00 +0530 Bridging the biotech communities Five hundred participants from 25 countries converged at BioAsia 2004 in Hyderabad. The summit lived up to its promise of being a platform for bridging the Asian and global biotech communities and underlined the potential opportunities that India offers to companies seeking to expand their operations. The three-day global bio business forum BioAsia 2004 (February 26-28) saw UNESCO Chair in Ecotechnology and Chairman of MS Swaminathan Research Foundation call for a genetic literacy movement and by the time the summit came to a close, Asia came together in a Federation of Asian Biotech Associations. Asian countries realize they have a lot of catching up to do in biotechnology and one way to accelerate the process is pool resources and build collaborative relationships within Asia. Genetic literacy divide could derail the progress on the front, hinted M S Swaminathan especially, in the case of genetically modified food, he said. Swaminathan also recommended that a National Resource Centre be set up for safe and responsible use of biotechnology and dissemination of information through media. According to CSIR-Director General Dr RA Mashelkar, reducing drug discovery costs and time to market is top of the agenda for the industry hence the immediate opportunity for India is in drug discovery, contract research and manufacturing, clinical trials and bioinformatics. "However, there is no reason why India cannot do well in basic biology," he said. Allaying concerns on IP and data protection in compliance with TRIPS Mashelkar said, "It will all be in place by 2005." Here are some highlights from first BioAsia 2004 held in Hyderabad: The first Genome Valley Excellence award was conferred on Prof. MS Swaminathan, UNESCO Chair in Ecotechnology and Prof. William Rutter, CEO, Synogenics LLC.   The B2B Forum coordinated by All-India Biotech Association (AIBA) Southern Chapter lined up 46 one-on-one sessions for the entrepreneurs. According to Dr A K Sadhukhan, vice chairman of AIBA, 12 MoUs were signed. He also mentioned four letter of intent have been released and another two MoUs are in an advanced stage.   The leaders of the delegates from Asian countries unanimously decided to launch a Federation of Asian Biotech Associations (FABA). Institutions, industries and associations dealing in biotechnology in various countries in Asia can become members by paying $300 as seed money. Dr M K Bhan, secretary, Department of Biotechnology, Government of India and BP Acharya, secretary Industries and Commerce Department, Government of Andhra Pradesh, have agreed to become patrons of FABA. A working group will be formed and FABA would be registered within three months. AIBA Southern Chapter headed by Dr BS Bajaj would work as convener. The agenda is to help Asian countries consolidate their strengths and accelerate development of biotechnology.   Jai Nagakatti , President, Sigma Aldrich Scientific Research listed chemistry as one of India's strengths and announced an investment of $8m on its R&D unit at the ICICI Knowledge Park in Hyderabad. The facility, a 50,000 laboratory scale production complex with 70-80 chemists doing contract research, process development and small-scale custom synthesis, is slated to go operational in early 2005. It will be the feeder center for company's large-scale production in Germany, UK, US and Switzerland. Sigma is ranked among the top 100 companies on the US stock exchange and has offices in 34 countries.   Andreas Wicki, CEO of HBM Partners, one of the world's largest venture capital fund in biotechnology sector, has set aside $10-$20 m for investments in the Indian biotechnology sector. Looking for later stage deals HBM partners is evaluating certain proposals for making investments through JV with Indian VC firms.   Abhiram Seth, executive director of Pepsico signed a MoU with D Nalini Mohan, additional secretary of Industries and Commerce and director of biotechnology, Government of Andhra Pradesh for taking up a project to support the livelihood of fisherman in the coastal belt of AP. To be established in the Marine Biotechnology Park, Visakhapatnam, the project involves cultivation of seaweed Eucheuma cottonii initially in Srikakulam and Guntur districts. Its derivative carragenan has binding properties that has applications in food processing industry, cosmetics, confectionary and pharmaceuticals. Pepsi will fund initial trials and the project will be coordinated by the Society for Elimination of Rural Poverty (SERP). The seaweed cultivated inside the marine waters has a cycle of 45-60 days and can yield $400-$500 per ton in the agricultural commodities market.   Six-month-old Aquas, a spin off of Bangalore headquartered Avestha Gengraine Technologies, is the first private sector company to be set up at the Agri Biotech Park, ICRISAT. The company is a JV between ICRISAT and Avestha Gengraine and is on its way to become an integrated quality testing and certification company for food, water and seed quality. According to Aquas CEO, Dr Villoo Morawala-Patell, the GMO testing and certification in India alone is estimated to be a $400 m opportunity and is expected to grow at 40 percent every year for the next five years. The company has tied up with US-based Genetic-ID for testing and certification of genetically modified organisms in food and food products exclusively in India and Bangladesh and non-exclusively in Pakistan. The company will expand its service offering through alliances with companies and institutions that develop these new age technologies.   Prof. William J Rutter, CEO, Synogenics LLC, mentioned about putting up a facility in Bangalore which will go operational in the Q4 of this financial year. It will be a sales company involved in selling diagnostic kits. The self-contained state-of-the-art kit manufactured in China comprises a reader and a cassette and is used in conducting blood tests.   At the trade show TCS was the hottest stall with a preview of their latest product in life sciences Bio Suite. The first product under the New Millennium India Technology Leadership Initiative (NMITLI), Bio Suite, is likely to be launched in April 2004.   Dr Anji Reddy of Dr Reddys Labs committed Rs 20 crore to the Life Sciences Institute coming up in the Hyderabad University campus. The top of the agenda project under consideration is on HIV vaccine. Nandita Singh, Cyber Media News India biotech is now on global VC radar After information technology global optimization comes to the biotechnology industry and those who are ready stand to gain. The opportunity is obvious. However, it is not just the labor arbitrage that drives the big opportunity to India. It is the proposition of India as a whole that matters. Country's strength in chemistry technology is being acknowledged worldwide, the cost of clinical trials estimated to be $150m per drug in India works out to 50-60 per cent less and the quality of manpower significantly brings down per head cost of creating IP. Besides the huge opportunity of drugs worth $53b going off patent in the next couple of years, beginning from basic biology research there is not an area of biotechnology that lacks potential in India. Little wonder that in last 10 days a number of VCs came over and made it a point to halt in Hyderabad in order to evaluate the investment opportunities. The point to be noted is all of them mentioned the Indian biotech sector interesting. However, biotech companies with US presence are the ones that will be the first ones to gain and later stage deals are likely to take prominence over start-ups. The insight comes from G Michael Alder, MD of Redmont Venture Partners Inc. Alder, who on day one of BioAsia 2004 insisted that great opportunity exists for India in pharma biotechnology and clinical trials only if the country puts IP and data protection framework in place, had his perception altered by day three of BioAsia. His earlier statement: "Believe me, the industry in the US does not believe that India can provide IP protection by 2005" had changed to "Seeing is believing." Alder explained this is his first visit to India and that how impressed he was with what he saw. In an initiative to take the partnership further he invited the Indian biotech industry to BIO 2004 to be held in Washington later this year. Growing opportunities for biotech companies through cross border linkages are worth capitalizing on. However, VC funding is not easy to come by even for companies based out of US or front-ended in US. Vipin Garg, president & CEO of Tranzyme Pharma couldn't agree more. He has raised five companies in a career spanning 19 years and is currently setting up operations in India. "Even if there is too much money floating in the VC industry, biotech is a unique high risk industry with at times incredibly long gestation. VCs ought to be cautious," he said. But long gestation period are hardly a deterrent to VCs who have been playing the biotech field. They just try and safeguard the investments. Andreas Wicki, CEO of HBM Partners, one of the world's largest venture capital fund in biotechnology sector, announced that they have set aside $10-$20 m for investments in the Indian biotechnology sector and expressed the intent to do it through a JV with an Indian VC. Though not everybody is willing to give away what they have set aside for investing in various geographies but right from Vinod Khosla of KPCB who was the first one to create a ripple by his India visit followed by Raymond Lane again of KPCB to Izhar Armony of Charles River Ventures, another US-based VC firm, all of them have been unable to resist checking out what exactly is the biotech noise all about. Low key evaluation and scouting for good deals is decidedly on.   ]]> <![CDATA[Products - March2004]]> https://biospectrumindia.com/news/95/1782/products-march2004.html https://biospectrumindia.com/news/95/1782/products-march2004.html Thu, 11 Mar 2004 17:17:00 +0530 Surepro-PF from Millipore Millipore has come out with a new high retention pre-filtration system called Surepro, which is designed to remove suspended particles from feed-water and protect the downstream water system with the required flow and pressure. This new filtration unit will prevent the premature replacement of RO cartridge in the water purification system due to a high particle load in the feed-water. Surepro is designed to handle SDI (Silt Density Index) values of even upto 100 and bring it down to required levels. It comes with an option of 5,3,1,and 0.5 micron filter with high retention efficiency and an optional carbon filter can handle very high organic loads and chlorine levels up to 5 ppm. The filtration unit has a DC diaphragm pump which boosts line pressure from 0 to 2 bars at 120L/hr and is designed to be operated with a range of water purification systems like RiOs, Elix and Milli-Q. The entire system is noiseless, user friendly and comes with a low and high-pressure cut-off, which is independent of the water system. For more information, contact: sheshadri@millipore.co.in ECOSCRUB air and gas purification system by Bry-Air Bry-Air has launched ECOSCRUB Air and Gas Purification System (AGP) for odor control in pharmaceutical processing areas. The product aims to eliminate offensive odor problems in both commercial and industrial environments like sewage treatment facilities, leather processing plants, sugar plants, food processing plants, restaurants, hotels and commercial complexes. ECOSCRUB is available in four different models ranging from 500 CFM (850 CMH) to 2000 CFM (3400 CMH), both as pressurization as well as re-circulation modes. All ECOSCRUB units are designed to operate and maintain odorous gas levels at 1 ppb or less. For further information, contact: enquire@pahwa.com Molecular Devices introduces SpectraMax SpectraMax® M2, from Molecular Devices Corporation is the first dual-monochromator, multi-detection microplate reader with dual-mode cuvette port for fluorescence and absorbance assays. The dual-mode cuvette port and multi-detection microplate reading capability will help life science researchers to replace multiple instruments currently used for spectrophotometry and spectrofluorometry with one compact, high-performance system. The SpectraMax M2 is the only multi-detection system to feature a dual-mode cuvette port and a single-read command capability for experiments requiring both absorbance and fluorescence microplate and cuvette detection in the same assay. The system reads endpoint, kinetic, spectrum and well-area scanning assays, such as ELISAs, nucleic acid, protein, enzymatic, cell viability and proliferation assays, and other homogeneous and heterogeneous microplate assays in 6- through 384-well formats. With SpectraMax M2 and Molecular Devices' patented PathCheckÃ’ Sensorâ€”the only technology available that measures the optical path length of samples in a microplateâ€”researchers can realize faster, more precise results by easily converting and optimizing very-low-throughput bench top assays for medium- to high-throughput. For more information, contact: cheri_salazar@MolDev.com ]]> <![CDATA[Dr Mashelkar on WHO commission on patents]]> https://biospectrumindia.com/news/95/6168/dr-mashelkar-on-who-commission-on-patents.html https://biospectrumindia.com/news/95/6168/dr-mashelkar-on-who-commission-on-patents.html Thu, 11 Mar 2004 17:12:00 +0530 Dr Mashelkar on WHO commission on patents Dr RA Mashelkar, director-general, Council of Scientific and Industrial Research (CSIR), has been appointed the vice-chairman of a commission on Intellectual Property Rights, innovation and public health set up by the World Health Organization (WHO). The commission will examine the data and proposals collected from different players in IPR and public health and work out funding and incentive mechanisms for the creation of new medicines for diseases that affect developing countries. Ruth Dreifuss, the former President of Switzerland, will chair the 10-member commission. Recently the APIDC Venture Capital Ltd (APIDC-VCL) has inducted Dr R A Mashelkar as chairman on its scientific advisory board. Commenting on his appointment, he said the boom in the biotech industry would provide growth for more start-up companies. To propel their growth, venture capitalists will have to focus and add value to the business through its growth phases. SR Chowdhury is drugs controller in Bengal The West Bengal state government has appointed Sajal Roy Chowdhury, a noted pharmacist and former general manager of Bengal Chemicals and Pharmaceuticals Ltd (BCPL), as the new director, drugs control, in the Directorate of Drugs Control, Government of West Bengal. Dr Chowdhury has been associated with the Bengal Chemicals for more than two decades and has played an important role in the turn around of the century old Bengal Chemicals. He succeeds Prof. Krishnangshu Ray. The government's insistence on appointing a medico for the post was scuttled thrice in the past. The Calcutta High Court had intervened in the matter directing that the appointment be handled by the State Public Service Commission (PSC). This is for the first time in its history that direct appointment was made through the PSC. Sanjeev Dani to head Ranbaxy India operations Sanjeev Dani, the head of Delhi hub of Ranbaxy India operations, has now been designated as regional director, Ranbaxy India operations. The vacancy was created after the elder son of late Parvinder Singh, Malvinder Mohan Singh, was inducted into the board and became presidentâ€“pharmaceuticals. Dani joined Ranbaxy in March 2001 after having worked with Johnson & Johnson in India and China. After a while, he came to head the New Delhi hub of the company's Indian operations. Besides Dani, there are other changes also at the top level in Ranbaxy. The company has roped in at least four new vice-presidents. Dr Vijay Batra, earlier with Schering Plough Research Institute USA, has joined Ranbaxy as the vice-president, pharmaceutical development. He will be looking after development of new chemicals entities (NCEs) and new drug delivery research (NDDR). Among the other significant new additions, Mohan Sharma, director HR (global manufacturing), has joined from Lupin Laboratories after serving there for over 22 years. Ameet Desai, director, mergers and acquisitions, has been elevated as vice-president, mergers and acquisitions and business planning. Ramesh Adige, new vice president designate-corporate affairs, has already been inducted. He is likely to take full charge from May this year. Adige has joined from Fiat India and was executive director there. Rinti Banerjee receives best paper award at BIMAO'03 Dr Rinti Banerjee, an assistant professor at School of Biosciences and Bioengineering at the Indian Institute of Technology, Bombay, has received the best paper award for her paper on surfactant nano particles for biomedical applications at the 14th National Biomaterials and Artificial Organs conference BIMAO 2003. A faculty of the biomedical engineering group that works on Biomaterials and Biointerfaces, Dr Banerjee had many awards to her credit including young scientist award from Department of Science and Technology, India and young researcher award from the International Foundation for Science, Sweden.     ]]> <![CDATA[BioNews March 2004]]> https://biospectrumindia.com/news/95/7704/bionews-march-2004.html https://biospectrumindia.com/news/95/7704/bionews-march-2004.html Thu, 11 Mar 2004 16:50:00 +0530 Avesthagen to spinoff another outfit for RPO Bangalore-based hot shot research organization Avestha Gengraine Technologies (Avesthagen) plans to spin off its research activities into a separate activity in April. The new company to be formed with an investment of $7 million (Rs 32 crore) is most likely to be named Villoo Morawala-Patell  Avesthagen Research Partners or Avesthagen Research Consultancy. The company will be incorporated in Bangalore formally in April. It will act as the research process outsourcing arm of the parent company, which holds highly priced intellectual property rights (IPRs) in bioagri and biopharma fields. "We have already set up offices or in the process of doing so for the new outfit in the United Kingdom, Copenhagen, Japan and Switzerland," Avesthagen founder and CEO Villoo Morawala-Patell told BioSpectrum in an exclusive briefing. The research outfit will have some 90 top rated scientists engaged in developing cutting edge IPRs in the core areas. The research arm is aiming to raise funds to the tune of $ 7 million. Two big investors have committed half the amount and other investments too are in the finalization stage. Avesthagen started commercial operations in 2001 and has since spun off two other companiesâ€”Avesthagen Inc, based in San Diego, California and AQUAS ( Avesthagen Quality Agricultural Services), located in the ICRISAT campus, Hyderabad. Avesthagen Inc is in the final stages of wrapping up $ 9 million (Rs 41 crore) and concentrates on the development of biotech drugs extracted from natural compounds to treat obesity and diabetes. The US arm of Avesthagen is ready with seven highly effective lead compounds, which have been scientifically validated and clinically tried out against diabetes. Products are likely to hit the market in late 2005. Morawala-Patell said the agriculture unit, Aquas, will have a seed capital of Rs 1.6 million (Rs 7.3 crore). The company has started to offer high quality purity testing and standardization test for exporters of agricultural products and seeds and is ramping up the infrastructure. " We have evolved a unique model in the biotechnology sector by spinning off specific activities to provide the best value for investors and also facilitate quick ramp up, leveraging the highly sought after IPR platforms developed by the company in recent years," Morawala-Patell said. Avesthagen currently has 41 international patents and has filed another seven in recent times. Cumulatively the company will have investments to the tune of $ 22 million (Rs 101 crore) and hopes to ramp of revenues with the new model in the next few years. The company has been funded mainly by leading investors like ICICI Ventures, Tata Group, Global Trust Bank, NMITLI program of CSIR. A few angel investors too have made generous investments. Bangalore Bio shifted to July The fourth edition of Bangalore Bio, the annual biotechnology event hosted by the Government of Karnataka since 2001 seems to be jinxed. The much-awaited event is most likely to be held in July instead of May 16-18 as announced earlier. The event, held in mid-April since its inception had to be postponed earlier to May awaiting the polling dates for the Parliament Election. The Election Commission's announcement of polling and counting date (May 13) on February 29 has led to yet another postponement of the event to July. Senior government and industry officials have decided to postpone the event after several rounds of discussions. May 16-18 was too close to the completion of the General Election and State Assembly election process. If the government formation was delayed it would have deprived the biotech industry to interact with the incoming policy makers. June was ruled out due to the prevalence of peak summer, which would have inconvenienced the strong foreign delegations. Also, the largest global biotech industry event, BIO 2004 is scheduled for June 6-9 in San Francisco would have clashed with the Bangalore event.  Shakti Bio comes to SP Biotech Park Jawahar Raja Shakti Bio Systems has plans to set up a state of art research facility at Shapoorji Pallonji Biotech Park, Hyderabad to conduct research on novel therapeutic strategies for the treatment of diabetes and cardiovascular disease. It has already purchased land of one acre for the purpose. The company aims at providing innovative tools for functional genomics in collaboration with its US based sister concern 'Targeting Systems'. Jawahar Raja, proprietor, Shakti Bio Systems speaking to BioSpectrum said, "Initially we are investing about Rs 5 crore for setting up the basic infrastructure at the park. The construction of facility at the SP Biotech Park is likely to be completed during the second half of 2004. Once it is ready the company will release its first line of products - transfection reagents for the gene delivery, protein/peptide/antibody delivery, S: RNA (gene silencing applications)." According to Dr Rampyari Walia, technical director, Shakti Bio Systems, "the genome valley project at Hyderabad with its unique supportive infrastructure, tie ups with research institutions, incubation center and other common facilities together with incentives offered to the biotech entrepreneurs by government of Andhra Pradesh have lead us to establish a biotech facility at Hyderabad."  Rai University hosts national biotech seminar The Bio Engineering and Research Center (BERC) at Rai University, a privately funded university with 25 campuses spread across the country is organizing a two day national seminar on "Biotechnology and Bioinformatics Challenges and Prospects" on March 27-28, 2004, at its campus in Mumbai. According to Dr VS Pingale, dean, BERC Rai University, about 150 delegates from various universities, colleges, institutes and industries are expected to participate in the national seminar. The seminar will have scientific session on biotechnology, bioinformatics, bioremediation, genetic engineering, gene therapy, stem cell and its application. The BERC at Rai University offers courses in BTech and M Sc in biotechnology. Currently 6,000 students are studying in various courses at Rai University. India preparing for clinical trails of AIDS vaccine India is preparing for the phase I clinical trial of a preventive AIDS vaccine developed for India, which is the result of a tri-partite memorandum of understanding between the Ministry of Health and Family Welfare, Government of India, Indian Council of Medical Research and International AIDS Vaccine Initiative (IAVI) in December 2000. The first phase of the trial will commence in 2004 in National AIDS Research Institute, Pune. SAS among the top software vendors SAS, the provider of business intelligence solutions to industries such as pharmaceuticals, manufacturing, etc. ranked in the top ten of the first-ever Vendor Value Study. This recent survey of nearly 1,300 senior IT executives and chief information officers ranked SAS seventh in the combined Vendor Value and Vendor Reliability categories. SAS was the only business intelligence software vendor to make the overall top ten in this research study. Jim Davis The study was done by CIO Insight magazine. SAS ranked seventh out of 41 major technology product and service vendors in the Vendor Value Study, with an overall score of 71.2 percent and also ranked seventh in the Vendor Reliability section with a score of 73.3 percent. SAS works hard to deliver what our customers want and to exceed their expectations by building strong customer relationships, and this survey validates that we are doing that better than any of our competitors. Our goal is to make our customers successful," said Jim Davis, senior vice president and chief marketing officer at SAS.             ]]> <![CDATA[A Bell Weather for Indian biotech segment]]> https://biospectrumindia.com/news/95/6992/a-bell-weather-for-indian-biotech-segment.html https://biospectrumindia.com/news/95/6992/a-bell-weather-for-indian-biotech-segment.html Thu, 11 Mar 2004 16:19:00 +0530 Biocon IPO A Bell Weather for Indian biotech segment Come 11 March 2004 and an important chapter in the Indian biotech industry would be written. Biocon Ltd, India's largest biotech company, will open its public issue on that date and close on 18 March 2004. It is a significant development because it is the largest and the most well known biotech company in the country, which is going public. Without any iota of doubt, the outcome of Biocon's issue will have a strong bearing on the fate and future of the biotech industry. Even Biocon knows this. Announcing the details of the IPO, Kiran Mazumdar-Shaw, chairman and managing director, Biocon said, "The IPO symbolizes the biggest milestone in our corporate mission. This is also important to the biotech sector. Biocon looks towards this with a deep sense of responsibility." The act of responsibility certainly is reflected in its issue. And Ms Mazumdar-Shaw is the first recipient of BioSpectrum Entrepreneur of the Year Award in 2003. Biocon will be issuing 10 million shares, equivalent to 10 percent of its post-issue capital (Rs 1 billion) through 100 percent book building method. The price band has been fixed at Rs 270 to Rs 315 per equity share of face value of Rs 5. "It is an IPO in real sense," remarked Naina Kidwai, managing director and vice-chairman, HSBC Securities and Capital Markets (India) Pvt Ltd. This is the sale of company's existing stock but the first sale of stock to the public. With over 1,100 employees Biocon and its two subsidiary companies, Syngene International and Clinigene International form a fully integrated biotechnology enterprise, specializing in biopharmaceuticals, custom research, clinical research and enzymes. Already a global leader in the enzyme sector, Biocon is fast consolidating its position in the world's statins segment. Statins are blood-clot fighting agents. With 20 patents on statins, its strategy of developing non-infringing manufacturing processes for statins that would help in their sale in the regulated markets once the products are off patent is paying off. The total revenues from the sale of four statins (Lovastatin, Simvastatin, Atorvastatin, Pravastatin) during the first nine months of 2004 was Rs 216.7 crore (67 percent of total biopharma sales) compared to Rs 120.20 crore in FY 2003. Presently it supplies statins to the US, EU countries and Japan. Some of its other significant business strategies include introduction of branded formulations in the domestic market. It is coming out with recombinant human insulin before July 2004, the clinical trials for which are in the final phase. With this, Biocon will have the largest Insulin production facility in the Asia-Pacific Region. Focusing on new molecules and not generics, the company is expanding its capabilities in drug discovery and developing new proprietary technology and products This makes Biocon distinct from other Indian drug-makers that rely on chemical synthesis, mostly to make medicines that go off-patent. The company holds about 130 patents, six of them in insulin making. Presently it is developing a drug to combat head-and-neck cancer in collaboration with a Cuban institute and clinical trials are on. Working on the holistic approach of discovery, development and commercialization it plans to focus on developing APIs for high value drugs, leverage expertise gained in one area to benefit its other business initiatives, expand capacity, develop new biologicals, and grow through strategic partnerships and M&A. Working on this clearly chalked out multifaceted strategy, Biocon plans to utilize the proceeds of the public offering for enhancing its submerged fermentation and chemical synthesis capacity in order to effectively meet the growing demand for biopharma-ceutical products. With a good business model in place, the company aims to grow at 30 percent a year, generating $1.0 billion( Rs 4,600 crore) in revenue within a decade. It expects solid growth in the next five years. And revenue figures posted by the company during the first nine months of this year substantiate this claim. The consolidated results for the 9-month period, ended 31 December 2003 showed a substantial increase in sales, operating profits and net profits as compared with the previous full-year period ended 31 March 2003. It has increased its total income for 9 months, at Rs 398.70 crore, a rise of 41 percent against the full-year income in fiscal 2003 of Rs 282.70 crore. Looking at Biocon's track record it has a reputation to deliver! Its public offering augurs well not only for Biocon but the entire biotech industry. The investors, analysts and industry alike are looking at the first IPO of the Indian biotech industry with lots of hope and expectations. Rolly Dureha Manju Sharma bids goodbye to DBTManju Sharma bids goodbye to DBT After a 9-year stint, Dr Manju Sharma has retired as Secretary, Department of Biotechnology (DBT) paving the way for her successor Dr M K Bhan on March 1. A galaxy of biotechnologists gathered at the National Institute of Immunology (NII), New Delhi to bid a formal farewell to her. Her mentor and former S&T minister Prof. MGK Menon was all praise for the retired DBT chief. "Dr Manju Sharma, according to me, is among the very few people who nurtured Indian biology. Not so long ago, biology in India was like a newborn child that required nurturing. She gave it all that was needed. We can learn from these past few years, that science cannot happen incidentally, it requires deep roots. She is among the pioneers who pushed life sciences into DST (Department of Science and Technology). She is the one who worked rigorously for National Biotechnology Board. In 1982, that board came into existence that led to the formation of DBT in 1986. All these developments have occurred because of her unprecedented efforts. Now we see people considering biotechnology as a magical field, it is all because of her initiatives taken way back." NII director Prof. SK Basu admired and appreciated Dr Sharma's management style. "The kind of affection shown by her for new biology was simply unmatchable. We can have leaders but it is really a pleasure for Indian biotechnology to have such leadership. Implementation of various orders with effectiveness, converting plans into reality, motivating the innovative workforce were some highlights of her tenure that touched me," gushed Prof Basu. Expressing his thoughts Padam Bhushan Awardee, Prof. G Padmanabhan stated, "Dr Manju Sharma was among those limited people, who deserve and will continue to deserve many more recognitions in the years to come. I think biotechnology in India has achieved a lot during these past 10 years." Sharing some of his memories while working with her, he said, "Some time back, here in Delhi, not many of us knew that Dr Manju Sharma was not in good health and was hospitalized in AIIMS. But even from there, she called up some people to discuss the future strategy on DNA vaccines. That particular meeting made me understand that how effective and keen she is while at work." Reflecting on her personal commitment and involvement for the people around her, Prof Asis Dutta of NCPGR, New Delhi recalled, " Recently I was hospitalized after an accident. By the time I got discharged from the hospital, it was Dr Manju Sharma who gave me 5â€“6 courtesy visits. At least for me, that memory will live in my heart. In other words, I will always remember Dr Sharma as a symbol of love and respect." Being the grand daughter of famous writer cum freedom fighter, Late Madan Mohan Malviya, a dedicated working style, determined attitude and oodles of love and affection come naturally to Dr Manju Sharma. She learned to work for the betterment of India at a very young age. "We can work further in the area of modern biology in India thanks to Dr Sharma who actually laid a strong foundation for the emerging biotechnology segment. I remember the time when we were talking about establishing a Center for Plant Genome. I was really confused and tensed how can it be worked out and then came her timely advice and help. In early eighties India got a center called the National Center for Plant Genome Research (NCPGR) in New Delhi. Interestingly such a center was needed not only by India, but Europe and the US were also interested in setting up something like this," added Prof Asis Dutta. When asked about Dr Sharma's contribution, Prof. PL Tandon of AIIMS replied, "I personally think of Dr Sharma as a source to convert difficult dreams into reality. Setting up a center for brain research was one of my dreams. But I was in a negative frame of mind because of the long procedures and enormous paper work involved. Then I met Dr Sharma, and she carefully read all the details and replied, lets do it. We worked on that and now India is known all over for its initiatives taken in brain research." Padma Shri awardee Prof M Vijiyan commented, "I am not only happy but also charmed to have a leader in science like Dr Sharma. India always requires such people with a high level of dedication and passion in science." However, when Dr Sharma herself was asked about her impressions of the recognition/awards that she has received, she simply replied with a smile, "I had only done my duties and fulfilled my commitments." And when asked about her future plans, she told BioSpectrum, "I cannot think of myself without science or biotechnology, so in some way or the other I will try to contribute my services to Indian biotech community." She may not fade into the sunset soon. There is a strong possibility of her coming back to the government as the advisor for biotechnology to the Prime Minister. This post is likely to be created for the first time in the government after the general elections in May. Faiz Askari & N Suresh in New Delhi ]]> <![CDATA[From Plasma to Biotech]]> https://biospectrumindia.com/news/95/7318/from-plasma-to-biotech.html https://biospectrumindia.com/news/95/7318/from-plasma-to-biotech.html Thu, 11 Mar 2004 16:17:00 +0530 Bharat Serums and Vaccines, a BioSpectrum Top 20 company, has the capability to take up a research project through all the phases of development independently with its own infrastructure and manpower. Bharat Serums and Vaccines was started in 1971 with a vision to make India self sufficient in the life saving plasma products as there was hardly any indigenous manufacturing of blood products in the country. Today, it has established itself as one of the fastest growing pharmaceutical firms in India with a CAGR of more than 50 percent in the last three years. The sales turnover stood at Rs 72.37 crore (2002-03) as against Rs 46.41 crore in 2000-01 and Rs 57.34 crore in 2001-02. "BSV is a very focused organization with a long-term strategy. Even though BSV is family owned, the directors besides monitoring the day-to-day operations are technically sound. It is poised for a big leap," said an employee of BSV. Bharat Serums was primarily started to fill the demand-supply gap in blood fractions and blood products. And later it became a leading supplier. With the changing times, though there is very good demand for its products (the current market size for plasma products in India is estimated at Rs 250 crore with no company manufacturing them indigenously), BSV has decided to look at long-term objectives and other lucrative options by investing more on R&D activities and focusing on biotechnology and Novel Drug Delivery Systems (NDDS). It has developed its competency in the areas of NDDS and in development and purification of equine-based therapeutic products. With a strong work force of 520, BSV was able to file eight patents of which five received approval. For future growth BSV is targeting the regulated markets for its products through "technology licensing". Stumbling blocks BSV had faced obstacles in its growth path. One of the major hurdles is the regulatory framework of the country which has not kept pace with the rapid technological advances in the areas of pharmaceuticals and biotechnology. During the last decade or so, BSV has been able to develop innovative products, many of them for the first time in the world. However the time required to reach the market, which is critical, has been considerably increased by the regulatory procedures and clearances. "The other challenges are very similar to any technology intensive industry. The continuous need to stay abreast with the technological advances, shorter product cycles and the constant need to provide products, which deliver better value to the customer at affordable costs require lots of investment in research and development," said Dr Vinod G Daftary, founder and chairman emeritus, Bharat Serums and Vaccines. Inspite of the challenges, BSV has some memorable events in its history of three decades. Dr Daftary, the man behind the success of BSV observed, "It is difficult to pinpoint one particular event as 'the' memorable event for BSV. The initiation of BSV, the grant of import substitution awards, the success of the R&D efforts in terms of the Indian and international patents for many drugs as well as launch of several innovative products, commissioning of our state of the art injectable facility at Ambernath, have all been remarkable events in our history. Recently BSV has signed a distribution agreement with Baxter, USA, for marketing and distribution of our drug Propofol covering over 40 countries. It is probably the first Indian company to supply finished formulation of an injectable drug to a MNC pharma company for the global markets." During 1982-96, BSV evolved the competency to develop novel drug deliveries, which it has now been able to leverage to bring out novel formulations and drugs as well as create intellectual property. Dr Daftary observed, "This has been one of the most fruitful periods for BSV." R&D initiatives BSV has always recognized the importance of R&D and hence has extensively focused on building in-house R&D capabilities to develop drugs, using emerging tools of biotechnology. It has made substantial investments in R&D infrastructure including high quality laboratory facilities, experienced research scientists and personnel. Investments made in R&D have been at par with international R&D spending at approximate seven percent of its turnover. Its R&D facility has been granted recognition by the Department of Scientific and Industrial Research. The company has developed core competency in developing NDDS (especially injectables) in the areas of anesthesia, anti-fungal and oncology. The technologies developed are patentable and would not infringe upon the existing technologies. BSV has been cleared by PCT on three of its patents and another seven applications are at various stages of filing and registration. Fruits of R&D work BSV has developed considerable market strengths in the domestic markets through its portfolio of niche primary line, life saving injectables at its production facilities at Thane and Ambernath. It has an animal farm at Khoni, which is equipped with facilities for immunization of horses, harvesting of plasma, plasma separation and on site testing facilities. It has in its portfolio over 25 brands, most of them having the potential of being marketed in the global arena. Exports would continue to propel its growth in the coming years. Its product profile includes plasma derivatives, monoclonals, equine antitoxins and serums, cardiovascular, antifungal, anesthetics and hormones. BSV has also appointed distributors in over 30 countries for its various products to enable continuous availability of its products in these countries. Brighter prospects BSV has a formidable product pipeline in various stages of development. Since it has quite a few potential blockbuster products in its portfolio, it is now looking for alliances with partners with proven strengths in the marketing and distribution of similar products. The preparations to meet the challenges of the TRIPS by 2005 will support BSV to become a key player in biotech industry in near future. Narayan Kulkarni "Confidentiality laws have to be strengthened" Dr Vinod G Daftary realized the need for domestic manufacturing of plasma products and founded Bharat Serums in 1971. In today's changed scenario, he shared his views with BioSpectrum on how BSV is gearing to face the challenges and the recent trends in the biopharma sector. What are your preparations to meet the challenges of the implementation of TRIPS in 2005? Our preparation for the TRIPS goes back to 1996 when a conscious exercise was undertaken by BSV to identify its key strengths, which could be leveraged upon to compete not only in the Indian market, but also on a global scale. The result of the competency analysis led to the formation of three R&D divisionsâ€”biotechnology, equine products and Novel Drug Delivery Systems (NDDS). BSV has always focused on high value niche segments of life saving injectable drugs. This focus continues to be the thread binding all development activities. We believe that significant technological entry barriers are the basic ingredients for long-term success of a product. While the equine products have no patent issues, the difficulties associated with animal management, expertise in handling animal serum and developing plasma purification techniques pose considerable entry barriers to potential competitors. BSV has also been able to extend its expertise in handling and purification of animal serums to handling of cell cultures and purification and has now a formidable pipeline of promising biotech products. BSV has been engaged in biotechnology development in recombinant proteins as well as monoclonal antibodies. We have adopted a slightly different strategy in biotech than most of the Indian companies by not focusing only on biogenerics. The NDDS developed by BSV have brought forth potential blockbusters, which would have global appeal and offer tremendous advantage over the existing therapy in terms of better efficacy and safety profile at affordable costs. This has also resulted in valuable intellectual property and a robust patent portfolio. As the industry is gearing to meet the global challenges, do you feel the necessity of a code of conduct for the biotech industry? A code of conduct for the biotech industry should be welcome. The implementation of TRIPS itself has awakened the industry for the need of some kind of code of conduct. Biotech is a resource intensive industry with comparatively long gestation period. Investments will be made in this sector only if commercial exploitation of intellectual property is possible and if the investors are assured of the returns. Being knowledge based, the confidentiality laws in the country have to be strengthened. Companies have to invest substantially to create their own intellectual capital over an expended period of time. Respect of other's intellectual property and knowledge, scientific manpower and maintenance of data security and confidentiality should be the cornerstones of the code of conduct. Do you face any competition from other Indian biopharma companies? BSV's pipeline consists of high value drugs some of which could be for the first time in the world. We would also seek patent exclusivity for such products. For other identified products, there are very few players on the global scene. Since BSV is following a radically different approach for its biotech foray, we do not foresee significant competition from most Indian companies. Which biotech areas will become the focus of biopharma companies in the near future? In the therapeutic field, substitution of naturally occurring compounds with recombinant proteins would continue to be the focus for most of the companies. One of the other areas, which is attracting a lot of attraction and will continue to do so for quite some time to come is the area of monoclonal antibodies, especially in oncology.     ]]> <![CDATA[Funding the BT boom]]> https://biospectrumindia.com/news/95/1147/funding-the-bt-boom.html https://biospectrumindia.com/news/95/1147/funding-the-bt-boom.html Thu, 11 Mar 2004 16:07:00 +0530 Funding the BT boom The biotech community will be watching with bated breath the performance of Biocon's much-awaited Initial Public Offer (IPO) of 10 million shares. For, the interest level is very high in the first IPO offering from a pureplay biotech company. Its success will give the confidence to other players who may be tempted to test their luck with the investor community to fund ambitious growth plans. Apart from regulatory hurdles, availability of venture capital has been the most discussed issue in almost all the biotechnology industry forums in recent times. National policy makers have been relentlessly bombarded by appeals from the industry to set up adequate venture financing to support early stage companies. The central government and Andhra Pradesh government have so far come to the rescue of the industry to some extent. The Technology Development Board (TDB), the New Millennium India Technology Leadership Initiative (NMITL), TIFAC and the biotechnology fund of the APIDC have to some extent met the funding requirements of the industry. Among the professional VCs, only ICICI Ventures has been the most supportive of the requirements of the industry. Other VCs have been watching the industry from the sidelines, mostly unwilling to commit themselves to the biotech industry's needs. It is partly driven by the "play safe" attitude of the financial community due to the long gestation periods, which is the norm with this sector. The other major reason is the lack of clear understanding of the long-term potential of the biotech sector among the VC community. This is the most surprising part of the whole issue. At most industry forums, VCs have taken pains to urge biotech entrepreneurs to market themselves better, keep knocking at the doors of the VCs, and sell their stories to make them open their purse strings. Stung by the dotcom bubble, VCs have turned too cautious. By and large, the biotech industry consists of first time entrepreneurs with strong academic backgrounds and it may take a while before these people learn the glib art of marketing. For the good of this emerging industry as well as for their own sake, VCs should come down from their high horses. After all they too have a job to do: to look for potential winners of the future. There is no guarantee that every biotech venture will be a money spinner. But at the same time, the ones who will make it, will become really big in this technology that touches the human lives intimately. The hit ratio may not be any different from other such promising sectors. After struggling for the last two years, a Bangalore-based biotech hot shop has managed to attract substantial VC funding. The most surprising part of this is the fact that after reading about this company's strong patent portfolio, a farmer from rural Karnataka chose to invest over Rs 1.25 crore in this company's equity. And learning about this, more of his farmer friends too want to do the same. The funds committed by these farmers are almost in the same range as that of some of the country's leading VCs. This makes one wonder why are our professional VCs so tight fisted. Fear? It is time they are helped to overcome this fear factor. What better way than more chats across the table to reassure the financial community. The industry should take the lead, for its own good. Fast.     ]]> <![CDATA[BioEvents March 2004]]> https://biospectrumindia.com/news/95/1578/bioevents-march-2004.html https://biospectrumindia.com/news/95/1578/bioevents-march-2004.html Thu, 11 Mar 2004 16:07:00 +0530 BioCapital Europe, the biotechnology investor conference organized by Fortis Bank and Life Sciences Partners, will take place at the Barbizon Palace Hotel, Amsterdam on 6 April 2004. This one-day conference will have speakers from the pharmaceutical, biotechnology and financial industry. Attendees will include venture capitalists and biotech/pharmaceutical executives, all looking to find the best investment opportunities within the biotechnology market. For further details, contact: anita@biocapitaleurope.com   Genomics & alternatives to animal use 2004 This international conference is an initiative of the Netherlands Genomic Initiative. It will be held at Crowne Plaza, Maastrich, Netherlands on June 2-4, 2004. In this work conference, leading experts from relevant research-areas will identify and evaluate the potential of genomics technologies and techniques to replace, reduce and refine the use of laboratory animals in biomedical research, to prioritize areas of particular interest and to draw up a strategy for further research, development, validation and implementation. For further details, contact: alternatives@genomics.nl   BIO 2004 BIO 2004, the annual BIO exhibition organized by the Biotechnology Industry Organization (BIO) will be held on 6-9 June 2004 in San Francisco, USA. This event is the world's largest biotechnology convention in the world. It is expected to attract more than 20,000 top-notch industry leaders, scientists, policy makers, academicians, and members of the media from all areas of the life sciences industry. This four-day convention will include programs that are representative of all disciplines, technologies, and other opportunities related to the biotechnology industry. For further details, contact: bio2004@bio.org   Bio-IT World Conference+Expo The 2004 Bio-IT World conference and expo being held on March 30-April 1, 2004 at Hynes convention center, Boston, MA brings together life science, IT, and healthcare professionals to discuss and evaluate the latest scientific, technological and IT breakthroughs in the post-genome sequence era. The event provides an opportunity to discover the latest technology, network with industry leaders, and learn how to accelerate R&D through the use of IT, informatics and life science technologies across the entire life sciences R&D value chain. For further details, contact: don_rosette@idg.com          ]]> <![CDATA[Why cloned animals but not cloned humans]]> https://biospectrumindia.com/news/95/7168/why-cloned-animals-but-not-cloned-humans.html https://biospectrumindia.com/news/95/7168/why-cloned-animals-but-not-cloned-humans.html Thu, 11 Mar 2004 14:54:00 +0530 Cloning means generation of exact replica. Nature has been exercising this option all through evolution. In fact, it was probably the only option it had for long after life appeared on our planet some 3.5 to 4 billion years ago. Prokaryotic microorganisms were almost certainly the first living things on our planet. Even today such microorganisms generally propagate through asexual reproduction, which is nothing but a natural way of cloning. But, then, man has acquired through evolution, a built-in imperative to try to do better than nature. So man has learnt to clone plants, all plants grown through cuttings are clones of the plant from which the cutting was derived, and microorganisms. In the second half of the last century, scientists also learnt to clone animal cells by growing them in tissue culture. Pushpa M Bhargava But human are a far cry from plants, bacteria or even other animals. For example, you can make a frog egg divide by itself and give a rise to a female frog. This process is called parthenogenesis. But human eggs refuse to respond to signals that would make a frog egg develop parthenogenetically. Similarly, while frogs are extremely resistant to bacterial infection, we (who call themselves so highly developed) are not. Again, we can make mouse monoclonal antibodies easily in the laboratory, the same technology (for which a Nobel Prize was given to Cesar Milstein and Georges Kohler) does not work for production of human monoclonal antibodies. The first breakthrough that laid the foundation of possible human cloning came in 1997 when British scientists succeeded in cloning the first mammalâ€”an adult sheep. Dolly, the clone, was produced by transferring the genetic material-containing nucleus from a cell of an adult sheep into an enucleated egg of another sheep. Since Dolly, many other animals have been cloned. In 1998, 50 adult mice were cloned from a single adult mouse and 8 calves from a single adult calf. In 2000, pigs and goats, and in 2002, cats and rabbits were cloned. And 2003 saw the production of the first cloned horse born on the 28th May in Italy. Although, recently, claims have been made about successful human cloning, none of them have been substantiated, even though no one doubts that human cloning is now feasible, whatever big jump it may be from other species to humans. Since we do not have an established human clone yet, this is the time to ask the question: should we or should we not encourage human cloning and invest in research on it? To answer this question, we must ask as to what use it all would be. As it is no longer a major scientific challenge, it must have some practical use for mankind to invest in it. Two such uses have been postulated: one individual and the other general. The individual use could be the satisfaction of ones ego or perpetualization of someone whom you may admire for whatever reason. So you may think you are an extraordinary person whom the world would miss; you may want too perpetuate yourself; or you may want to clone Madhuri Dixit, Shabana Azmi, Sachin Tendulkar or MF Husain, for you admire them. This is what is called reproductive cloning. The other reason would be to generate organs for transplantation on a human. Today, at any given time, there are over 90,000 people waiting for a kidney transplant, but there are only some 2,000 kidneys available. Further, transplant of a kidney from an individual, a homograft, requires the recipient of the foreign kidney to be kept on expensive immunosuppressive drugs for a long time. Commercial therapeutic cloning could change the scene. If you need a kidney transplant, the organs from your cloned fetus could be harvested just after oraganogenesis has begun, grown further in organ culture and then transplanted on you. Since immunologically they would be just like your own organs there would be no immune response and, therefore, no need for immunosuppressive drugs after the organ transplantation. The reason given above for reproductive cloning does not stand scrutiny. We are what we are because of two factors: genetic and environmental. The genetic factors determine our capabilities and the environmental factors determine the extent to which these capabilities would convert into abilities. Therefore, while your clone would have the same capabilities as you, since the environment in which you were brought up, the extent to which these capabilities would convert into abilities and the fall out of this process would be very different in the case of your clone than in your case. Therefore, the clone will not grow up to be identical to you. Thus reproductive cloning would make no sense. It would only lead to frustration on the part of the person who is being cloned, besides waste of resources, it would also make the life of the clone extremely difficult because of the expectations from the clone, which he/she may not be able to meet. On the other hand, therapeutic cloning makes sense. There should be no objection to it until the time we learn to grow more organs from totipotent stem cells. What about cloning of other animals? I am all in favor of cloning animals, other than man, for reasons such as those that I give below. Today's repertoire of medicines for various human diseases and disorders includes a large number of therapeutic human proteins. Till recently, they had been very expensive, if available at all in any reasonable quantity. We have been able to reduce their cost by making microorganisms produce some of them through genetic engineering. We can reduce the cost of such proteins further by having them secreted in the milk of appropriately genetically engineered cattle, sheep or goat. In fact, it has been shown that we can have them secreted at concentrations of 1 to 15 milligrams per milliliter, which would make the cost of their production of the order of about one dollar per gram. Thus reducing their cost by several orders of magnitude in comparison to today's cost of such proteins. The way to do this would be to produce one animal, say through microinjection of the desired DNA in early embryos or even the zygote and then hoping that at least one animal treated in this way would give us the desired phenotype. We can then clone this animal and produce any number that would secrete the desired protein in their milk. Cloned animals can also serve as a source of organs for xenotransplantation on humans. It is now widely recognized that pig is the most suitable animal to donate organs to humans. But there is a serious problem of hyper immune rejection. It is now possible to produce genetically engineered pigs in which this protein is inactive. Once one such genetically engineered pig is available, there is no reason why we should not be able to clone it to give us a perpetual supply of organs to be used in humans when the technique of xenotransplantation is perfected. Mules are extremely useful animals but, being a hybrid, they are sterile. In 2003, mules have been cloned. There are still problems that need to be solved but, when perfected, the mule cloning technology may be of great commercial value for India. Horses are often castrated to improve performance in respect of certain activities. The recent success in cloning horses could be used for cloning such castrated horses that have a highly improved performance. In fact, what is becoming clear is that genetic engineering and cloning will often go together in the future. This would have immense possibilities in the area of developing new classes of animals that would solve some major problems of humans. Unfortunately, in our country, there is virtually a total lack of awareness of the above. Let me give an example of this lacuna. Shantha Biotech, highly respected pharmaceutical company that produced the first genetically engineered product in the country, and the National Dairy Research Institute, one of the most prestigious laboratories, of the ICAR system, jointly submitted a project under the Millennium Initiative that is administered by the CSIR, for producing genetically engineered and cloned animals for secretion of drugs into their milk. The project was not approved and no viable reason was given. The reason can only be non-scientific, for much less meritorious projects have been liberally funded under the above initiative. Pushpa M Bhargava is one of India's most brilliant scientists. He founded and directed the Centre for Cellular and Molecular Biology (CCMB), Hyderabad. ]]> <![CDATA[Green Gold]]> https://biospectrumindia.com/news/95/1553/green-gold.html https://biospectrumindia.com/news/95/1553/green-gold.html Thu, 11 Mar 2004 14:49:00 +0530 LEGAL VIEW Green Gold A method of treating a surgically inflicted wound by applying turmeric powderâ€¦ Doesn't it sound like what your grandmother taught you years ago? This was the turmeric patent that eventually got knocked off. Are we the only sitting targets? Salagen is the new pill for xerostoma, the dry mouth syndrome, a pill with pilocarpine as its active ingredient, derived from a shrub that was once used by the Tupi-Guarinis tribe of Brazil to induce salivation. The Tupis continue to chew the leaves of the shrub while an American corporation is reaping huge benefits. Salagen, in fact, is not an isolated instance. Who has not heard or lamented about Neem, Basmati, Haldi or Jamun piracy? Or the Enola bean story? It is estimated that more than 3,000 patents today are plant based and more than 50 percent of the top 150 prescribed drugs in the US are said to be based on traditional knowledge. Welcome to the valley of green gold, where biopirates are uncrowned kings and nature is the pasture for a quick buck. The new gold rush is not limited to exotic vegetation or soil, but includes isolated molecules, bioactive fractions, gene sequences, plants and herbal formulations. Biopirates counter that whilst a natural material may have been known to a tribe, refining and isolation of the actual molecule imparting that property from the plant requires effort, skill, systematic study and trials which calls for substantial investments. Hence, intellectual property rights protection is well deserved. But what about erosion of the green cover and recompense to stakeholders/source? What about the effort of local communities in conserving valuable species, plants and animals and on which they depend for their food and livelihood? Biopiracy undoubtedly is a serious threat to biodiversity and the environment. It threatens the right of local communities to biodiversity, weakening their ability to conserve natural resources. Its here to stay. Can we control it? The solution may be multi-facetedâ€”legal and through government initiatives. One possible way forward is the defensive method of preparing databases of plants, extracts and their uses, in several languages and make it accessible to patent examiners in various countries. Such databases being foreign "publications" would force the USPTO and EPO to think twice before issuing neem-like patents. India and China have adopted this approach and it is reported that the database has more than 4500 entries. Such initiatives, if started on a local scale by native Americans and Aborigines of Australia, may be more successful and provide opportunities for conservation of resources as well as possible industrial use. Hoping that a legal provision mandating conservation of natural resources, equitable sharing and sustainable use of natural resources may make a difference, an International treaty, the Convention on Biological Diversity (CBD), took effect. Nearly 150 countries are members, including India. The CBD legitimizes a market for bio-resources and tries to strike a golden mean between undue exploitation and conservation. To comply with obligations under CBD, countries such as Philippines have enacted legislations wherein access to biological resources is exclusively on "no permit, no collection" basis and heavy fines are imposed on those in breach. Benefits arising out of utilization of biological resources are to be shared with local communities and such communities are entitled to participate in all levels of decision-making. Similarly, India has passed the Biological Diversity Act, 2002; the law though is not in force as yet. As per the scheme of the Act, Biological Diversity Boards at the central and state level are to be set up and compensation for use of biological resources is to be paid to the local communities/government. Other salient features: Any person desirous of using biological resources occurring in India for research or other purposes will have to seek permission from the Biological Diversity Board. Transfer of resources as well as acquisition of IP rights is subject to permission from the Authority. Local communities inhabiting forests are entitled to receive compensation from parties using their biological resources or knowledge Non-Indian bodies required to obtain prior approval of National Biodiversity Authority for purposes of research, commercial utilization, biosurvey or bioutilization of biological resources occurring in India or knowledge associated therewith Transfer of the results of any research to a non-Indian or a body with foreign equity entails prior approval of the Authority The Authority while granting approval may impose benefit-sharing fees or royalties or both. Any contravention of this provision is an offence, punishable with a fine or imprisonment or both. Collaborative research projects between an Indian and a non-Indian, including between institutions are to conform to the policy guidelines of the central government and are to be approved by the central government Any person, whether Indian or non-Indian, or bodies with foreign equity, shall apply for any IP rights in or outside India for any invention based on research or information on a biological resource obtained in India without the prior approval of the National Biodiversity Authority In cases of patents, the permission may be obtained after acceptance but before sealing (grant) of the patent. The Authority may impose benefit-sharing fees or royalties or both for sharing of financial benefits arising out of such research Local community is entitled to receive rewards for use of resources and knowledge within their jurisdiction and negotiate with authorities. The success of this law depends on its implementation. For now, it is the Patents Act, 1970 that makes it mandatory for a patent filer to mention the geographical source and origin of a biological material used in an invention. Absence of such a disclosure or failure to disclose could potentially lead to revocation of patent. Costa Rica is reported to have a similar law. Although it may be quite difficult for one to track patents granted and whether they have indeed used any biological material owned by a local community, it is a step towards conservation of biological resources. The Patent Bill 2003 mandates obtaining of "prior informed consent" of the right holder even prior to filing of a patent application. While obtaining "prior informed consent" may pose significant hurdles in obtaining patent rights, it is yet another step that will have to be tested on the touchstone of implementation. Government initiatives by way of policies may also go a long way in promoting conservation of natural resources and improving livelihoods of indigenous communities. Such as contracts between a company and the local communityâ€”the Merck model wherein Merck, in 1991, in exchange for rights to screen, develop and patent new products from plants, microorganisms and animals, paid about $1.1 million to local bio-diversity program and the national environment ministry of Costa Rica. The contract also had a clause for return of unspecified percentage of royalties earned from resulting products. Back home, an Indian tribe has shown by example what "equitable benefit sharing" means. A group of scientists from the Tropical Botanical Garden Research Institute (TBGRI) while conducting a survey in the forests in the Agasthya Hills, Kerala, found that the secret of energy of the local Kanis lay in a berry that they ate. The plant producing the magical berries is locally called Arogyappacha and has been grown and used for generations by the members of Kani tribe. This plant was later identified as Trichopus zeylanicus ssp. travancoricus. Detailed chemical and other investigations led to the identification of glycolipids and other compounds with immuno-enhancing properties. The fruits had anti-fatigue properties. TBGRI developed a herbal formulation Jeevani containing Trichopus, which adorned the shelves of every pharmacy in 1995. Half teaspoon of this herbal formulation in warm water with sugar (if needed) is a powerful energy booster and mind relaxing nutritional supplement. The TBGRI shared royalties earned out of this product with the Kani tribal community and it is reported that a trust has been formed of which 60 percent are members of the Kani tribe. An important aspect of the Kani story is that they had implemented "benefit sharing" even while the concept is to take root in many parts of the world. Another method may be the use of confidentiality agreements or trade secrets whereby developing countries may license their knowledge to the highest bidder. Given the insatiable desire of pharma companies to explore and develop new medicines, the need to improve livelihood of indigenous communities and the need to conserve biological resources, denial of access or exploitation is not the answer since it may only encourage underhand means. An equitable solution that brings financial rewards and conserves biological resources, technology transfer, employment and eventually leading to national prosperity is the future picture and all initiatives must be headed in that direction. Is anyone listening? Rajeshwari, K& S Partners: rajeshwari@knspartners.com J Sagar Associates is a leading national full service law firm and K& S Partners is an IP focused law firm. Both the firms provide legal services to several domestic and international biotech clients. Henceforth senior people from these companies will write on the patent issue. ]]> <![CDATA[Bioprospecting: A Mega Billion Prospect]]> https://biospectrumindia.com/news/95/7500/bioprospecting-a-mega-billion-prospect.html https://biospectrumindia.com/news/95/7500/bioprospecting-a-mega-billion-prospect.html Thu, 11 Mar 2004 14:39:00 +0530 Ajeet Mathur Biotech firms are building cross-border value chains on an unprecedented scale in a bid to discover and develop new active ingredients from traditional medicine. This has created strong incentive for the future of bioinformatics, bioprospecting as well as for the biopiracy. Communities and countries rich in biodiversity and knowledge of traditional medicine may gain, if they share the trade and investment benefits. This is possible when their knowledge is used with prior informed consent and they participate in the design of benefit streams that arise from the global developments of the healthcare industry. Worth of Traditional Knowledge By its very nature, traditional knowledge requires participation of holders of such knowledge or on their behalf before such knowledge can be priced as a marketable economic asset. This process can be accomplished in a number of ways but any path would involve several stages of resource and response development and the flows of costs and benefits can differ greatly depending on how rights in such knowledge are created, pari passu, with other existing intellectual property rights regimes. Further, moral rights, legal rights and property rights may overlap, but not necessarily. Humans have always passed on knowledge about life, living, livelihoods, lifestyles, nutrition, healthcare and hygiene inter-generationally as part of kinship, cultural and social traditions of bequeathing lived experiences of our habitat. If the intended beneficiaries are located within a limited space or limited sentience of a community, no institutions beyond the family or clan or tribe or community network are necessary to ensure continuity in such traditions. The sufficiency of substituting intermediating agencies such as learning institutions (schools, gurukuls or workshops) or administrative agencies deriving tax revenue or acting as religious functionaries (priests, shamans) to function as information conduits may also be reasonably presumed. Bio-information can be used globally through partnerships, trade and other forms of cross-border transfer-pricing arrangements, if tacit knowledge held communally can be converted to articulated information under a system of flexible property rights. This could raise the value of traditional knowledge by enabling it to be priced to correspond to its true international market value. However, institutions that would yield dispersed benefits do not emerge easily and there is a profit to be made if local knowledge has a use and commercial value beyond its local context. All forms of contemporary knowledge, whether tangible or intangible are amenable to coverage under IPR regimes unless someone prefers to hold them as trade secrets and succeeds in doing so. Non contemporary traditional knowledge to the extent that is tangible as in case of in situ plant varieties that occur in nature or codified informational resources regardless of whether the information is in print or digitalized databases can also be protected to the extent that organic resources can be brought within the protective scope of plant varieties protection under Convention on Biodiversity and information resources can be protected under the Copyright or other forms of IPR. A Marketable Economic Asset The worth of traditional knowledge may also be estimated from arrangements pharmaceutical firms have made in different places and the amounts they are willing to pay for exclusive rights of bioprospecting. In an agreement between Costa Rica and Merck, the latter obtained a monopoly right to bioprospecting in Costa Rica for an annual fee of $508,000 with a promise of 50 percent royalty share in any marketable product developed. Another firm, Shaman Pharmaceuticals operates a parallel non-profit firm called "Healing Forestry Conservancy" through which it ploughs back at its own discretion, a unilaterally determined part of the value extracted from indigenous people and shamans in Asia, Africa and Latin America. There is not much to choose between the risk of regulatory capture and private markets because either solution can exclude the holders of traditional knowledge from being parties to a negotiated contract. The use of biological resources can also be linked to permits and know-how licenses for medicinal knowledge where bioprospecting is authorized through people's biodiversity registers as in Peru and India. In the case of the Arogyapachha (Trichopus Zeylanicus) used by the Kani community in India for its anti-fatigue effects, the plant came to the attention of a scientific expedition in 1987 and was found to activate the body's natural defenses by acting on the cellular immune system with hepato-protective, anti-peptic ulcer and cholorectic effects. The drug "Jeevani" developed from this herb was patented by Kerala's Tropical Botanic Gardens Research Institute as contemporary knowledge and the Kani community rewarded with a 50 percent share in royalties through a trust fund together with remuneration for participation in its expanded cultivation and development. This brought considerable prosperity to the Kani community and raised their income by an average about Euros 200 (Rs 12,000) for every household. The demand for this product exceeds the supply capacity, which is constrained by bureaucratic hurdles over the cultivation rights of tribals on forestland. May Apple (Podophyllus peltatum) used by native Americans for centuries as an ameliorate for skin warts, ulcers and cancerous growths is the source of Etoposide used for the treatment of cancerous growth with $500 million world market value. Vinca alkaloids originating from the traditional medicinal use of periwinkle have led to blockbuster drugs Vincristine and Vinblastine with estimated global sales of $300 million. Oil of evening primrose (Oenthera) used by indigenous populations in the Americas for skin problems is currently marketed for eczema and pre-menstrual problems with an estimated market of over $400 million. And, Australian smoke bush (Conospermum) given by aborigines to their old folk was found to contain Conocurvone, a substance that treats rheumatism and lumbago and destroys HIV virus in low concentrations with the predictable outcome that a private Victorian firm Amrad financed by an American institute now pays A$100 a year to the Western Australian government for the exclusive privilege to develop the discovery. Prospectable Biological Resources In many cases, while captive commercial cultivations exist, the plants can no longer be found in nature by the indigenous communities that historically found their properties and used them. This has also happened with Rauwolfia Serpentina, once common in the forests of India and Nepal as the source of reserpine, which is now on the endangered list. It is not known what benefit, in any, was shared by the drug developers with the communities concerned in these cases. Commercial bioprospecting of plant genetic resources is informed by traditional knowledge of indigenous peoples and value is created when tangible organic elements and intangible informational resources come together. A hit rate of 80 percent or more can be achieved in developing medical drugs where the screening of plants is limited to species used as medicine by indigenous communities (mainly angiosperms). The access to a country's plant genetic resources is governed by an evolving mosaic of national laws, international conventions, multilateral agreements concerning biodiversity and intellectual property rights and plurilateral codes of practice developed in the context of sui generis modalities created in the work of the Food and Agricultural Organization (FAO). Biological resources are, inter alia, economic goods and include valuable traditional knowledge. Prospectable biological resources comprise two categories: organic resources and informational sources. The availability of organic resources depends on maintaining biodiversity of the biosphere in three important respects: genetic diversity within a species, species diversity within an ecosystem and ecosystem diversity within a habitat. Biotechnology, genetic engineering techniques and the commodification of biological resources have increased the potential value of bioprospecting because scientific advances enable us to isolate, identify and synthesize life forms which can provide a rich source of new building blocks not only for medicines but also for dyes, colorants, perfumes, chemicals, pesticides, biosensors, bioelectronics and biochips. Bioprospecting may be viewed as being only partly concerned with harvesting tangible organic material for genetic manipulation or for exploiting the information provided by the organic material. A second source of informational resources are compilations of information in the form of publications, databases, gene banks on the basis of which bioprospectors can learn about phenotypes (observable characteristics of life forms) and genotypes (genetic composition of life forms) and use or maintenance of organic resources. A third source is ethno biological knowledge, an important channel for communicating experiences based on direct experience of natural systems because the chemical arsenals of plants represent more than 300 million years of evolution of ecologically active compounds and industries need information which could convert organic resources into a usable form in the market economy. The main problem to be solved in the economics of bioprospecting is that while it is certain that certain kinds of knowledge produced through bioprospecting will eventually increase the productivity of resources used, the use of the resources can be classified neither as a cost nor as an investment without knowing whether the end-result is going to be some viable product or a saleable parcel of knowledge. Ajeet Mathur is professor, Indian Council for Research on International Economic Relations, New Delhi and University of Tampere, Finland.   ]]> <![CDATA[Genzyme to buy Ilex for $1 billion in stock]]> https://biospectrumindia.com/news/95/2407/genzyme-to-buy-ilex-for-1-billion-in-stock.html https://biospectrumindia.com/news/95/2407/genzyme-to-buy-ilex-for-1-billion-in-stock.html Thu, 11 Mar 2004 13:11:00 +0530 Genzyme to buy Ilex for $1 billion in stock Genzyme Corp. and ILEX Oncology have announced a merger agreement under which ILEX shareholders will receive shares of Genzyme common stock valued at $26.00 per share, or approximately $1 billion in equity value. Excluding amortization, the transaction is expected to be dilutive to Genzyme's near-term earnings and accretive in 2006. Henri A Termeer With this transaction, Genzyme takes a significant step toward fulfilling its goal of building an oncology business. ILEX offers a strong franchise with a growing marketed product, a promising pipeline with two late-stage products and a first-class clinical development organization. The pipeline significantly augments Genzyme's long-standing program in oncology, which includes a research and early development portfolio with particular strengths in antibodies, small molecules and cell-based therapeutics. The merger also capitalizes on Genzyme's substantial expertise in biologics and targeted therapeutics, and its expanding oncology testing business. Genzyme is one of the world's top five biotechnology companies, with 10 major marketed products and a global regulatory, manufacturing and commercial infrastructure "This transaction is a very good strategic fit for Genzyme that provides us with a solid franchise in the important field of oncology," stated Henri A Termeer, chairman and chief executive officer, Genzyme Corporation. "Through this merger, we gain an experienced team that has brought a cancer therapy from development to market. The combined strength of the ILEX program and Genzyme's oncology pipeline expertise and infrastructure will provide the foundation for a sustainable and competitive commercial oncology business." ILEX's lead pipeline candidate is clofarabine, a next-generation purine nucleoside analogue that inhibits both DNA and RNA synthesis. ILEX is currently investigating clofarabine for use in pediatric and adult acute leukemias, as well as advanced solid tumors. ILEX has initiated a rolling New Drug Application (NDA) with the FDA for treatment of relapsed or refractory acute leukemias in children following receipt of a fast track designation and Genzyme expects approval of clofarabine in 2005. ILEX recently reported positive interim results from Phase II studies for clofarabine in pediatric and adult acute leukemia. Phase I studies evaluating clofarabine in advanced solid tumors are currently underway in both intravenous and oral formulations. Aegera announces $15 million financing Aegera Therapeutics, a leading Canadian biotechnology company, announced the closing of their Series C financing round. Led by the VenGrowth Advanced Life Sciences Fund and strongly supported by new and existing investors, Aegera raised $15 Million to fund multiple clinical trials of its two lead drug candidates. Aegera's lead oncology program, which will soon begin Phase 1 clinical trials, is a second-generation antisense therapeutic targeting the X-linked Inhibitor of Apoptosis Protein (XIAP) for multiple cancer indications. Aegera's second oncology program is a small molecule that alleviates the untreated side-effect of chemotherapy-induced neuropathy, which will enter formal development later this year. "This financing, supported by almost all of Canada's leading private biotechnology investors, is the strongest possible affirmation of the value of our exciting clinical development plan and expertise on the central role of apoptosis in cancer," stated Michael Atkin, president and CEO. "The use of proceeds will accelerate and strengthen our XIAP antisense clinical programs in multiple indications and geographies, allow pre-clinical development of our small molecule neuropathy compound, and build a pipeline of proprietary small molecule therapeutics and line extension opportunities as future clinical candidates." Genzyme Acquires Alfigen Genzyme Genetics, a business unit of Genzyme Corporation, announced that it has purchased substantially all of the assets of Alfigen Inc., a national genetic testing provider based in Pasadena, California. This transaction brings together two organizations committed to excellence in genetic testing. The purchase of this privately owned laboratory business allows Genzyme Genetics to expand its extensive test menu and service offerings. Alfigen offers innovative testing technologies and services, such as preimplantation genetic diagnosis, genetic counseling and continuing medical education programming. "This acquisition provides us with an opportunity to not only leverage Alfigen's 20 years of experience within the industry, but also to utilize our existing assets and bring the combined service offerings to customers of both Alfigen and Genzyme," says Mara Aspinall, president, Genzyme Genetics. "Like Genzyme, Alfigen's commitment to advancing science is supported by an excellent staff and we are working closely with the Alfigen team to effect a smooth transition. We are eager to continue to provide the highest quality of prenatal, oncology and other testing to physicians and patients." Hollis-Eden to acquire Congressional Pharma David J Grdina Hollis-Eden Pharmaceuticals announced that it has acquired all of the capital stock of Congressional Pharmaceutical Corporation (CPC). CPC is a closely held company with exclusive intellectual property rights licensed from the University of Chicago to develop a series of compounds that have the potential to protect against DNA mutations that can occur as a result of radiation injury or chemotherapy. This DNA damage (mutagenesis) has been associated with an increased risk of a variety of different cancers and is believed to be a primary cause of the harmful long-term effects of radiation injury. In exchange for CPC's capital stock, CPC stockholders are receiving shares of Hollis-Eden Common Stock, as well as the right to receive additional shares of Hollis-Eden Common Stock based on the achievement of certain development milestones. In addition, CPC stockholders may be entitled to receive royalty payments upon regulatory approval and commercialization of products covered by the licensed intellectual property. The intellectual property rights acquired by Hollis-Eden consist of a series of patents and patent applications that relate to discoveries made by David J Grdina, professor of radiation and cellular oncology at the University of Chicago. Dr Grdina, who has agreed to an exclusive consulting arrangement with Hollis-Eden for the development of this technology, is widely recognized as an expert in radiobiology and has worked closely with the Armed Forces Radiobiology Research Institute (AFRRI) and the Walter Reed Army Institute of Research over the last twenty years in the development of products for use against radiation injury. In 1983, Dr. Grdina established at the Argonne National Laboratory the program for use of phosphorothioates to prevent radiation induced mutagenesis, and was the director and program leader for Radiation Biology using the JANUS reactor, the only nuclear reactor designed strictly for radiobiological use. Dr. Grdina has published over 145 peer-reviewed papers in the fields of radiation and cancer biology. CPC's lead candidate to prevent DNA mutations from radiation exposure is phosphonol. Hollis-Eden expects to begin profiling phosphonol in a series of animal models designed to assess the safety, efficacy and oral bioavailability of the compound. The Company is also preparing to begin a dialog with the United States Food and Drug Administration (FDA) about specific development objectives that would be required for approval of the compound. Hollis-Eden believes that phosphonol may be eligible for review by the FDA pursuant to a recently enacted rule for countermeasures to weapons of mass destruction. According to this new rule, in the event it would be considered unethical to conduct efficacy studies in humans, a product may be approved on the basis of efficacy in relevant animal models and safety in humans. Neurocrine acquires Wyeth's Indiplon Gary Lyons Neurocrine Biosciences has purchased from Wyeth all of Wyeth's financial interest in indiplon, Neurocrine's late stage clinical development compound for the treatment of insomnia. Neurocrine will now retain all milestone, royalty and other payments on Indiplon commercialization that would have otherwise been payable to Wyeth. The transaction also provides Neurocrine ownership and control over the indiplon composition of matter patent, which expires in 2020. The transaction is valued at approximately $95 million, with $50 million payable in cash and $45 million payable in Neurocrine common stock at a 15-day average price preceding the signing of the agreement. "The acquisition of the indiplon royalty stream from Wyeth has important strategic value for Neurocrine and its shareholders. This transaction leverages our strong cash and equity currency to bolster future earnings. Our indiplon royalty obligations of six percent are now reduced to three and one-half percent and will be accretive to earnings in our first year of commercialization," said Gary Lyons, president and CEO of Neurocrine Biosciences. Upon approval of the transaction Wyeth will assign to Neurocrine its license agreement with DOV and all of Wyeth's right, title and interest in and to the indiplon composition patent filed by Neurocrine in Wyeth's name. Wyeth's financial interest in indiplon arises out of a 1998 license agreement between Wyeth and DOV Pharmaceutical, Inc. in which Wyeth licensed the indiplon technology to DOV Pharmaceutical in exchange for milestone payments and royalties on future sales of indiplon. Algorx raises $65 Million AlgoRx Pharmaceuticals, Inc., a privately-held pharmaceutical company, announced that it has raised $65 million through a Series C financing led by Advent International. The company has raised more than $89 million since its inception in March 2001. AlgoRx also announced that Charles Cohen, a partner at Advent International, has joined the company's board of directors. "The success of this financing and the strong interest from such high-quality investors validates our excitement in the medical and commercial opportunities for AlgoRx's products," said Ronald M Burch, president and CEO, AlgoRx. The company's first product, ALGRX 4975 (capsaicin for injection), a treatment for localized severe and intractable pain, recently completed two positive Phase IIa studies and will be evaluated in additional Phase II trials during 2004. Domantis raises $33 million Domantis Ltd, a leading Domain Antibody (dAb) therapeutics company, announced that it has raised $33 million in a Series B financing round led by 3i Group PLC (UK). Other new investors include Gray Ghost LLC (Baltimore, US), Albany Ventures (UK) and an undisclosed institutional investor from the United States. The company's existing shareholders, MVM (UK) and Peptech Limited, the quoted Australian biotechnology company, also participated in this round. Domantis' CEO, Robert Connelly said, "We are delighted to have closed one of the largest Series B rounds in Europe over the last 12 months and to have attracted such a high calibre group of international investors. The new funding will enable us to fast track our lead dAb programs into the clinic to demonstrate human efficacy, whilst building a substantial discovery, preclinical and clinical pipeline behind them." Domain Antibodies have broad therapeutic potential in conditions including respiratory disease, inflammation, cancer and cardiac disorders. They also support multiple product formats, such as dual targeting molecules that can hit two separate therapeutic targets in a single product. Furthermore, dAbs can be used in a variety of diverse formulation and delivery options (e.g. oral and pulmonary administration), providing more effective drugs with reduced side effects. NeurogesX gets $35 Million NeurogesX, Inc., a specialty pharmaceutical company focused on the development and commercialization of novel treatments for improved relief of neuropathic pain, announced it has raised $35 million in a Series C round of equity financing. Leading the round was new investor Global Life Science Ventures who was joined by Diamond Capital Management as agent for Dow Employees' Pension Plan and the Union Carbide Employees' Pension Plan. It has raised approximately $65 million in total equity investments since its first equity financing round in June 2000. "We are excited by our progress in developing potential treatments for neuropathic pain for both postherpetic neuralgia and painful HIV-associated neuropathy," said Anthony DiTonno, CEO and President of NeurogesX. "This funding will allow us to complete our pivotal trials for NGX- 4010, expand our technological capabilities, acquire additional products and submit the NGX- 4010 NDA." NGX 4010 is an advanced, clinician-administered dermal treatment for neuropathic pain with a profile unlike currently available neuropathic pain treatment options, which are associated with systemic side effects and inconvenient dosing regimens. In a phase II clinical trial, a single administration of NGX-4010 provided a profound and clinically significant reduction of pain in postherpetic neuralgia patients, beginning shortly after treatment and lasting for at least twelve weeks. Similar results were demonstrated in a pilot Phase II HIV-associated neuropathy trial. There have been no significant safety issues seen to date. It plans to commence studies of NGX-4010 in painful diabetic neuropathy patients in the second half of 2004. Enzo Biochem acquires assets of Oragen Enzo Biochem, a leading biotechnology company specializing in gene identification and genetic and immunological regulation technologies for diagnostic and therapeutic applications, has acquired the assets of OraGen Corp., a privately owned biotech corporation specializing in immune regulation technologies, headquartered in Morristown, NJ. Enzo said that the acquisition will broaden its proprietary intellectual and technological capabilities in the area of immunological regulation, particularly as it relates to the treatment of infectious diseases. Enzo stated that the acquisition is in line with the company's strategy to act on opportunities that can be accretive to its efforts in accelerating its developmental program. "The addition of OraGen's technology in developing immunological therapies for infectious diseases, particularly hepatitis B, provides an added dimension to our Company's considerable intellectual property and product development in this area," said Elazar Rabbani, Ph.D., Chairman and CEO of Enzo. "Given Enzo's advanced position in the field of immune regulation, combining our technology with Enzo's program makes eminent sense," said John Callahan, President of OraGen. "It's an exciting prospect." Medsurge to purchase Cryo-Genomics Medsurge Medical Products Corp. has entered into an agreement to purchase Cryo-Genomics Ltd and all its rights, patents, and proprietary technologies with regards to 2 tier Faecal Occult Blood Testing (FOBT). FOBT is the gold standard for Colo-Rectal Cancer prevention with studies indicating that one third of all Colo-Rectal cancer deaths can be prevented through yearly FOBT testing. Further investigation reveal an enormous market size whereby every person over the age of 50 should have FOBT done annually as compared to hemorrhoid banding which affects one in four people over age 55 in their lifetime. The sell price of the slides and reagents for testing would sell for a similar price as the O'Regan Ligator. The potential estimated market size is therefore in excess of $15 billion per year. The product is complimentary and ideal for colo-rectal health clinics and Medsurge's existing world distribution network, as hemorrhoids that usually bleed, should be banded before FOBT is performed. Marc Morin, President and CEO of Medsurge, said, "Entering the cancer prevention market is a further indication of Medsurge's commitment to lead in bringing to market proprietary niche patented medical technologies. I would like to thank everyone involved for their many months of work on this project ."                                 ]]> <![CDATA[Uttranchal's biotech response]]> https://biospectrumindia.com/news/95/2176/uttranchals-biotech-response.html https://biospectrumindia.com/news/95/2176/uttranchals-biotech-response.html Fri, 13 Feb 2004 16:16:00 +0530 Uttranchal takes lead in agribusiness in North India. The state of Uttaranchal is actively focusing on agribusiness. To discuss the technologies and prospects of business in Uttranchal, the Government of Uttaranchal, CII, and DASP jointly held AGRICON 2004 in the GB Pant University of Agriculture & Technology. "The agriculture sector in Uttaranchal faced many challenges and abundant opportunities," said MS Mahara, minister for agriculture, Uttaranchal, at the inauguration of AGRICON 2004. He expressed hope that that the deliberations at the conference would be able to provide possible solutions to some of the challenges. Clearly, the State was very eager to attract entrepreneurs to the state. Chief Minister ND Tiwari stressed that adoption of new technologies across the agriculture value chain could make India a major player in the international markets vis-Ã -vis agricultural products. His message reiterated that Uttaranchal is the "numero uno' investment destination. The Chief Minister's address also conveyed the state's interest in biotechnology. ND Tiwari stated, "In future, technology would be a major driving force in agribusiness. Hence, adaptation of technology across the value chain such as biotechnology in crop and animal products for productivity enhancement or value addition to processing/packaging technology for better shelf life would be a novel tool to cater to future food consumers." The Uttaranchal state has already prepared the State Biotechnology Policy and is to be released officially soon. Sanjeev Chopra, secretary, industrial development, Uttranchal said, "Biotechnology is a tool that every enterprising economy can adopt. Not just agricultural production system, but also the entire gamut of pharmaceuticals, nutraceuticals and the health industry can also attain heights through this application." Addressing the session Gautam Thapar, chairman CII Northern Region, stressed on the need for agriculture becoming competitive, both for domestic and international markets. Dr PL Gautam, vice chancellor, GB Pant University was also present there and expressed his positive views about the technological aspects for growth into Agribusiness. Delivering the valedictory address, the State Governor, Sudarshan Agarwal asked the state to keep up its tempo and stressed on the need for growth and sustainable development of Agribusiness. He also felt that modern tools and techniques should be nurtured within the state so that industry can grow. The two-day event showcased the potential of the State in the Agribusiness sector. Faiz Askari, In Pantnagar, Uttranchal               ]]> <![CDATA[Heady days for Nutraceuticals]]> https://biospectrumindia.com/news/95/1263/heady-days-for-nutraceuticals.html https://biospectrumindia.com/news/95/1263/heady-days-for-nutraceuticals.html Fri, 13 Feb 2004 16:14:00 +0530 Thanks to the growing acceptance of nutraceuticals, India could hope to leverage the country's key resources in this area to gain a foothold in the global market. The first line of defense for most people struggling with stress and depression consists antidepressant medications. But some recent studies indicate that these drugs may not have much role in the prevention of stress and depression. However, the growing awareness of the serious side-effects of prescribed antidepressants has encouraged people to look for alternatives to maintain a healthy mood in less severe cases. Nutraceuticals are among the New Age drugs that are being developed to provide better health. Nutraceuticals are gaining public acceptance in many developed countries in recent times. Could India become a major supplier of nutraceuticals to the world ? What is the government's position on this? Explained RB Rawat , CEO of the National Medicinal Plants Board (NMPB) of the government: "This board has recently been set by the Ministry of Health And Family Welfare. In November 2000, NMPB came into existence. The core area of focus for this Board is the growth of medicinal plants sector in India. The other objective of NMPB is to coordinate between all matters relating the medicinal plants, including drawing up of policies and strategies for conservation. Proper harvesting, cost-effective cultivation, research and development, processing and marketing of raw material are among few topics that we are looking on very carefully." After giving a bird's eye view of NMPB, he also highlighted the importance of nutraceuticals into this segment. "If you see the changing trends, the market of nutraceuticals has huge potential. These days industries are showing interest in the nutraceutical area. And that is a good sign. Within few years this potential can turn into a healthy growing market," stated Rawat. Discussing the developments at NMPB, Rawat added, "At the national level 32 medicinal plants have been prioritized for development. The information on cultivation of 32 prioritized plants has been compiled and published as booklet entitled "Cultivation Practices of Some Commercially Important Medicinal Plants". Moreover, we have taken successful initiatives in forming 26 State Medicinal And Plant Boards to address the related issues for development and growth of medicinal plants sector in the country at the regional/state level." "Herbal medication has gained popularity in cosmetics. People are now showing their interest in herbal applications into other forms as well,"Dr RU Ahmad, director of Pharmacopoeial Laboratory for Indian Medicine. A leading expert and the director of National Botanical Research Institute (NBRI), Lucknow, Dr P Pushpangadan explained the concept of nutraceutical: "The nutraceuticals or the functional foods are majorly plant-based products and most of them being predominantly herbal. Hence clues to these nutraceutical products could be got from our ancient and traditional systems of medicine like Ayurveda, Siddha and Unani. The 'Rasayan' and 'Vajikarna' therapeutics of Ayurveda are essentially nutraceuticals and therefore there is ample scope for India to develop a range of nutraceutical/health food products. And to succeed, these products have to be standardized and with scientific validation to ensure safety and efficacy so as to instill confidence in the customers to use them not as an alternative medicine but as a well defined system of medicine. For this to happen, there has to be research carried out on these products. Thus India's own traditional knowledge base gathered from Unani, Ayurveda and Siddha can help out in research work on nutraceuticals. And we can take a lead on this from the western world." Even after having core expertise in all the three fieldsâ€”Unani, Ayurveda and Siddha, what is the status of Nutraceutical research work in India? Replying to this query, Dr Pushpangadan said, "There are a lot of products sold in the name of nutraceuticals in the Indian market. Close to around 100 products are even listed on the Internet along with the global companies and around 20 Indian companies have a record of producing nutraceuticals and marketing them globally. India is relatively a new market. The size of the Indian nutraceutical market is estimated to be about Rs 1,600 crore in 2001. All major pharma players are in the process of entering this market. The level of exports from India is still small, estimated to be perhaps less than Rs 750 crore, if one excludes Psyllium. The major markets for India are the US, Europe and Japan." Talking about nutraceutical's acceptability among Indian consumers and researchers, Dr Pushpangadan added, "Definitely this nutraceutical concept is catching up in India as well. The growth rate of catching trend is also impressive. This is evident with the increase in the number of companies investing in this herbal drug industry. As far as research community is concerned, they are also showing great interest in this, but establishing a state-of-the-art modern laboratory for undertaking research on nutraceuticals will cost at least Rs 10 crore. That might be one reason that only few major players of the Indian healthcare/pharma industry are coming into this foray." Commenting on the scope of nutraceuticals, director of Pharmacopoeial Laboratory for Indian Medicine (Ministry of Health and Family Welfare), Dr RU Ahmad stated, "Herbal medication has gained popularity into the area of cosmetics. People are now showing their interest in herbal applications into other forms as well. Nutraceuticals is one of the examples of options that can be availed easily for securing peaceful and healthy life. India can become leader in this field as we holds key expertise as well as we are rich with the biodiversity." Dr Ahmad also said, "There is a gap in attitude of our's and the west. We always follow what the western community has already achieved. The Indian industry needs to grow more mature." However, comments from the industry drivers on this subject can be very critical and vital for the curious people about nutraceuticals. Head of the Research and Development initiative of Flex Foods Ltd, Dr S D Garg,  expressed his confidence in nutraceuticals and said, "Nutraceuti-cals has a big international market, no doubt about this. In India, the market is negligible. This is an area from where we can achieve excellence. All that is required at this moment is our efforts in the correct direction." Hopefully, a "Shining India" will soon gather the momentum required to make a global mark in this sector too. Faiz Askari   ]]> <![CDATA["India Needs a Comprehensive Biotech Policy"]]> https://biospectrumindia.com/news/95/2058/india-needs-a-comprehensive-biotech-policy.html https://biospectrumindia.com/news/95/2058/india-needs-a-comprehensive-biotech-policy.html Thu, 12 Feb 2004 14:29:00 +0530 On January 13, the government has announced the appointment of Dr Maharaj Krishan Bhan as the new secretary of the Department of Biotechnology(DBT) to replace Dr Manju Sharma on her superannuation. A well-known pediatrics scientist, Dr Bhan's appointment to this key policy making job indicates the government's new emphasis on health care issues. The previous two incumbents were from the biopharma and bioagriculture segments. Dr Bhan was selected through a rigorous nationwide process with a High Level Search Committee short listing half-a-dozen potential candidates from the large community of biotech researchers. The Appointments Committee of the Cabinet chose Dr Bhan on January 13. Dr Bhan is taking up the assignment on March 1, 2004. Dr Bhan is currently a Professor of Pediatrics and Chief, Pediatric-Gastroenterology and Nutrition at the prestigious All India Institute of Medical Sciences (AIIMS), New Delhi. He started his distinguished career after completing MD in Pediatrics as Assistant Professor at the Post Graduate Institute of Medical Research (PGIMER), Chandigarh. His contributions in the development of various vaccines against diseases in children have been widely acknowledged by the scientific community. Dr Bhan is a fellow (FNA) of the Indian National Science Academy, and the Academy of Medical Sciences. He was given the prestigious Shanti Swarup Bhatnagar Award in 1990 for Medical Sciences. During the last two decades he has been propagating oral rehydration therapies in Indian villages and districts and the guidelines prepared by him for oral rehydration and treatment of persistent diarrhea have reached physicians all over India and helped reduce child mortality. He is the Chairman and Member of several Advisory Committees in Pediatrics related programmes and research of several organizations both in India and abroad. He has published over 150 research papers, most of them in prestigious international medical journals. Dr Bhan readily agreed to share with BioSpectrum his impressions about the status of the biotechnology segment in this country even though he is set to take over his new job only a month later. In this Exclusive interview, Dr Bhan outlines his vision for the Indian biotech sector, emphasizes the importance of partnership with the industry in tackling various issues jointly and stresses the importance of setting up an efficient, understanding, competent and fast acting regulatory mechanism for the sector. Excerpts: What prospects do you foresee for the country in various segments of biotechnology? There are several segments which have good prospects for the growth of biotechnology in the country. Health and agriculture are two promising areas. In the last two to three years, we have had good signs of growth in these segments. But the next five years will be crucial for the biotech industry. There are some societal aspects that require proper attention. Areas like vaccines, bio therapeutics, diagnosis hold good potential for the development of the entire biotech industry. There are some areas that are yet to be explored even though we have expertise in those areas. Among these, immunotherapeutics offers a great opportunity for development. We, as a nation, need to focus on this area and come up with something good. Should the country choose some segments in biotechnology which are highly promising from capability point of view and concentrate on these? If so, which areas do you thing hold the best promise for India? Food and agriculture offer a lot opportunities for us. There are many more things to be achieved in these sectors. Priority issues in this area are technologies that aim to increase crop yields, development of plants with drought resistance and insect resistance traits .I think productivity gain for the agriculture systems in degraded lands and hostile climatic environments is an important issue that needs to be tackled. Other than this, development of non foodgrain crops and livestock is also an important issue. In healthcare, improving the nutritive value of the food intake of children is one of the most important tasks. We also have ample opportunities in the field of molecular medicine. We need to tap these aggressively. As a matter of fact, deficiency of iron, zinc and calcium is very common among Indian children. Targeted plant breeding methods to improve the mineral contents in common foods can help in tackling this problem. Nutraceuticals can become a vital tool for this. Dr Bhan's priorities Create synergy with industry with emphasis on speed, efficiency and effectiveness. Publicize that GM foods "do no harm" among people in partnership with the industry. Initiate public-private partnerships to boost investments and a mechanism to reimburse industry investments in biotech R&D. Boost quality of human resources in biotech. Work on a comprehensive National Biotechnology Policy. Reorient National Bioinformatics Policy with industry thrust. We need to concentrate on genetically engineered seeds. Enzymes for industrial use is also an area that is unfurling some good opportunities and companies are doing good well in this segment. Bioinformatics and Bioservices are also among the thrust areas for us. Apart from all these, there is a huge potential for the export of these products and services. The government has yet to formulate a National Biotechnology Policy at the Central level, whereas at least half-a-dozen states have announced biotech policies. How do you intend to give a strategic direction to India's biotech thrust? As a part of the earlier vision and direction of DBT, we had expanded the sector in the country. We expanded industry wise, developing good research tools and trends. But now there is a need to move forward. We have done a lot in terms of Biosafety and related issues. In fact, biotechnology needs a comprehensive policy. I will try to contribute my services to formulate one. At the same time, what is more important at this moment is the implementation of policies. India has a global reputation for making policies. At the same time, the bigger challenge is to implement the policies. It is my perception that outstanding management is what is lacking and we should concentrate on this. Other than this, we are doing good but we definitely need to grow and we can. So we should focus on our growth and keep on delivering good science. Which are the major areas that require improvements in the Indian biotech industry? I believe that achieving a balanced price level of biotech products is a crucial aspect relevant to the masses. We need to focus carefully on the need to take the benefits of science to the Indian people. The first step in this direction could be an efficient health insurance scheme. I believe health insurance should be promoted more aggressively. Because the success of any science depends upon its adaptation. For example, there are any number of healthcare institutions that offer liver transplantation services. But the fact is that only small numbers of people are opting for this treatment mainly due to the high costs involved. Insurance schemes could make such treatments affordable. Since its formation in 1986, DBT has been playing a catalytic role in developing the nation's capabilities in biotech research and human resources development. Will DBT play a similar role in the near future in catalyzing the growth of a vibrant biotech industry too? As discussed earlier, DBT played a major role in developing high quality of human resources for biotechnology. That itself is a key aspect of motivating the industry. Now, we need to take feed back from the industry. It would be a great initiative if the industry gives us regular feedback about the kind of human resources that we deliver to them. We have to make some basic minimum guidelines in terms of assuring the quality of people that we are generating for the biotechnology industry. And we can also partner with industry in terms of delivering good HR forces for them. Just like the research community, industry too deserves a high quality workforce, and I am open to partnering with the industry on such issues. Projects and fund distribution have been DBT's main tasks so far. Will DBT take a pro-active industry role too soon? As a good example, we can look at the Department of Science and Technology ( DST) initiatives in which the department is ready to reimburse part of the industry's R&D investments.DBT will also take such steps. DBT has already initiated several public-private partnerships. I believe within next five years we will come up with some good examples of such partnerships. Multiplicity of regulatory authorities in biotech has been a major hurdle facing the industry. Do you intend to push for harmonization and simplification of the regulatory processes with DBT playing a key role as an expert agency? I have personally experienced the various aspects of dealing with regulatory agencies during vaccine development. In the US the regulatory mechanism is far more challenging than that of India. The procedures of regulations in the US is not an easy nut to crack even though their regulatory mechanisms are known widely around the world. However, the main reason for their good reputation is their effectiveness. Everytime I use to send any query or file an application, I got a reply from them within a very short time. That keeps motivating the applicant. I think speedy efficiency is what is required at this moment in India. But we cannot compromise on quality checks. Apart from developing such expertise in efficiency, we should work on developing and maintaining better management methods. I strongly believe that improvisation of the regulatory management system should be taken up on priority basis. Through DBT I also intend to support various government organizations which are working parallel in dealing with the biotech industry in India. Proper training is required for existing human resources in such government organizations which deal with an aggressive biotech industry. I will try to take such initiatives through DBT. A National Bioinformatics Policy formulated by DBT exists. But it is mainly a statement of the department's own bioinformatics network. How can the nation leverage quickly the globally-acclaimed software skills and integrate with the expertise in biotechnology to create another enduring success story? No one can achieve anything without taking the first step. The formulation of the National Bioinformatics Policy has been a great initiative. But, now we need to move ahead. From DBT's own statement we will expand it into a national level initiative. For doing so, we need to collaborate or partner with industry on this. We cannot carry out any successful work all alone. We would deliver good scientific tools and techniques if we work as a team. Will the government set up a series of national centers of excellence along the lines of Indian Institutes of Technology (IITs) to develop world class human resources in biotechnology and related areas? So far, DBT has tried to put seed money in creating the infrastructure for biotechnology. I believe rather than starting from 'Ground Zero' which involves building new institutes or centers of biotech excellence, we can tie up with existing' centers of exellence' that have evolved over several years. But there are some specific areas where we can develop some institutions or centers where the focus would be purely on technology transfer. Actually, frankly speaking, I have been thinking about these for some time. Development of such centers or institutions can be developed with industry's participation. Anyway, I have only spent few weeks being so close to DBT. I will learn things fast. I have always admired the initiatives and developmental work done by this department India has been rather slow in using genetically engineered products. Only one product in the agriculture sector has been approved for use so far. Should we adapt such a cautious approach to a technology widely used in the US for over 15 years? On the other hand, with emphasis on process patents, the nation has reaped the benefits of modern medicines developed in the West quickly. Why should we be unduly defensive on biotech products? There are few factors that are directly linked to the acceptance of GM foods in the Indian market. The scientific technology/accountability, societal and political factors are among those few. The GM market scenario in India can be improved by spreading the right communication about it among the people. There is no doubt that GM food can have good prospects. We have a regulatory mechanism in place that is doing a thorough risk assessment part. but all we need is to make it take decisions quickly. We have to ensure that our people understand everything about GM foods. A policy of 'DO NO HARM' needs to be conveyed. Through DBT I would love to spread correct information about these technologies. To do so we may partner with the industry to form a committee or task force to communicate to the public about biotechnology. Biotechnology services, especially clinical trials and contract manufacturing and health care services, may be another goldmine for India. Will the government remove some of the regulatory bottlenecks and speed up the development of this sector? In areas like clinical trials a developing country like India needs to bring in world class expertise. Specifically speaking about clinical trials, these contribute a lot to product development. Personally, out of curiosity, I always ask one question while doing clinical trials: will this product be easily available to the Indian masses at reasonable or affordable prices? I would love to see India as a New Drug Development center. Phase 1 clinical trial for any drug is a big challenge or you can say, a big bottleneck. But we cannot ignore the regulatory bottlenecks. At the same time, we have to be more aggressive and speed up our processes. European and American companies are looking towards India to cater to the needs of their basic vaccine requirements. Some Indian companies are already ramping up their productions. Could India become the preferred Global Supplier of essential vaccines in a few years? Its good for us that we come under the bulk vaccines manufacturing countries. India and China are two leading countries in vaccines development. We hope that we will continue to do well in this area and improve our pace of growth. Your work on the development of vaccine against rota viral infections and diarrhea is well recognized. How will you pursue these developments through DBT? We have a good team here at AIIMS ( All India Institute of Medical Sciences, New Delhi). We have a strong collaboration with industry, In fact in my experience this is one of the best collaborative project on diarrhea vaccine. The institute is also very supportive of us in this project. I hope this program will continue with same aggression and attitude in the future too. Recently you had represented India in the development of the diarrhea vaccine. How soon will such a vaccine be ready and is there a road map to reach it to the people fast? The drug is now into phase 2 clinical trials. Another drug is still into phase 1 trials. We are satisfied with the kind of results that the drug is showing to us. Within three years the picture will become clear. If the vaccine is proved to be effective, it will be available at an affordable cost. In a recent statement, you had emphasized the need for developing DNA or recombinant vaccines. What is the status of this in India, and are there any specific plans you have made for developing such vaccines? Simpler vaccines have already been developed. On going basic research on immunology in DNA vaccines indicate high potential. We desperately need to develop DNA vaccines for improving human health in India. DNA vaccines hold more promises for humans as they could be used on new born babies pretty safely. It is an attractive opportunity for both industry and society. Infections like SARS and 'Bird Flu' have become more prevalent in recent years. India has been lucky to keep these infections away. What preventive measures, including development of vaccines, should the nation undertake to safeguard India's health and economy? Infectious disease control is not entirely depended on technology. Effective surveillance is required in developing a tool for checking any infectious disease. Developing vaccines in controlling such diseases comes after this. It is good for India that we have number of good institutions that are working on controlling infectious diseases. What is your immediate task at DBT? In the next couple of months I will try to learn more, observe and listen about biotechnology in India. For supporting the industry I would love to initiate any feasible project. My emphasis will be on creating synergy with the industry. Synergy with speed, efficiency and effectiveness. Faiz Askari and N Suresh     ]]> <![CDATA[Change of Guard]]> https://biospectrumindia.com/news/95/1058/change-of-guard.html https://biospectrumindia.com/news/95/1058/change-of-guard.html Thu, 12 Feb 2004 14:21:00 +0530 Change of Guard The New Year has certainly brought good tidings to the fledgling biotechnology industry. There are several indications that biotechnology might finally become mainstream, getting out of the confines of laboratories. One of the surest signs is Prime Minister A B Vajpayee's inclusion of biotechnology as one of the identified areas of cooperation with our neighboring countries after the early January summit of the heads of SAARC governments in Islamabad. So far this was reserved mainly for culture, science and technology and information technology (IT) as trade and other such areas have always remained controversial for any meaningful cooperation between the countries. IT too was confined to the sidelines till the mid-1990s when the amazing growth rates of software exports caught the national attention. And then every national leader tried to bask in the software sunshine by making use of every available forum to talk glowingly about India's software expertise. The probability of biotechnology attaining similar cult status among the nation's influential person is very high for the simple reason that this "technology of life" can have equally if not more far reaching impact on a much larger section of people than IT. Another clear sign of the future is the appointment of the new secretary of the Department of Biotechnology (DBT), the apex policy making body of this sector in the government. The secretary-designate Dr Maharaj Krishan Bhan is an acclaimed health care expert as the developer of diarrhea vaccine. Industry watchers feel that the government is sending out a clear signal from Dr Bhan's appointment that the health care aspect of biotechnology requires a clear thrust. This is also clear from the first ever detailed interview given to BioSpectrum by Dr Bhan where he clearly talks about the need to quickly share the benefits of modern health care biotech developments with the largest number of people through appropriate mechanisms such as balanced price and health care insurance. Equally important is Dr Bhan's emphasis on forging partnerships with the emerging biotechnology industry in speeding up the regulatory processes, creating awareness about the benefits of biotechnology among people, willingness to partner with the industry to rework the national priorities in this sector as well as the offer to consider all feedbacks from industry leaders. Why am I really optimistic about the growth of the biotechnology industry? In recent weeks, we have heard not just "feel good" stories about the national economy but also the talk about India becoming a major hug for industrial research and the global hotspot for the manufacture of small cars. Together these sectors have the potential to transform the Indian economy, along with IT-enabled services to an altogether new growth trajectory. To this, we could add another sector: vaccines. As the cover story of this issue indicates, there is every possibility of India becoming one of the world's most preferred destinations for manufacture of a host of essential vaccines. The global market for vaccines is growing at over 10 percent and is currently pegged at $6 billion. Clearly, with some of our enlightened biotech companies taking the lead in this area, a new world of opportunity to meet the world's vaccine supplies is reaching our doors. Some companies like Serum Institute and Indian Immunologicals have already taken the lead in some products. It is only a matter of time some of the enlightened entrepreneurs grab the opportunities. With Dr Bhan promising a quick, efficient and effective regulatory mechanism, the biotech Moon (or Mars) is within our reach.   ]]> <![CDATA[If it can't work, fake it]]> https://biospectrumindia.com/news/95/1264/if-it-cant-work-fake-it.html https://biospectrumindia.com/news/95/1264/if-it-cant-work-fake-it.html Thu, 12 Feb 2004 14:20:00 +0530 For years, they made us believe that genetically modified (GM) crops reduce pesticide applications and thereby help in protecting the environment. For years, they worked hard, manipulating scientific data, to justify the increasing public investment in a risky technology. For several years now, they have succeeded in diverting the public attention. The citadel of scientific fraud has now begun to crumble. Amidst reports that the pesticides application in GM crops in the United States has actually multiplied, comes the damming indictment of the faulty technology from the crop fields in Africa. Trials to develop a virus-resistant sweet potato, launched in Kenya in 2001 by the US special envoy, Dr Andrew Young, have failed. The much-hyped GM technology, that was claimed to usher in a green revolution in Africa, has finally turned out to be a scientific crap. The virus-resistant sweet potato, donated by Monsanto to Kenya Agricultural Research Institute (KARI), has been found to be susceptible to viral attacks. This is the same sweet potato that a black African woman, in her colourful traditional dress, has used in her non-stop global sermons on feeding the hungry in Africa. Sponsored by the US Agency for International Development (USAID) and Monsanto, Dr Florence Wambugu of KARI, has gone around the world telling how the transgenic potato could raise the crop yield from four to ten tonnes per hectare. The media loved her. The media, in fact, adores everyone who speaks in favor of the GM crops. After all, the future of the world lies only in increasing the corporate profits, which in turn benefits the media. So whether it was The New York Times, The Washington Post, CNN, or the discredited Fox TV, they all clamored around her. The Forbes magazine even went to the extent of naming her among the 15 people from all over the world who will 'reinvent the future'. Reports now indicate that the transgenic sweet potato yields less than the traditional varieties. In other words, knowing that the transgenic sweet potato wouldn't work, Dr Florence Wambugu, had faked it. Earlier, Aaron deGrassi of the Institute of Development Studies at Sussex (UK) too had picked up holes in Dr Florence Wambugu's claims. In a detailed report on GM crops in Africa, he had said: "Accounts of the transgenic sweet potato have used low figures on average yields in Kenya to paint a picture of stagnation. An early article stated 6 tons per hectare - without mentioning the data source - which was then reproduced in subsequent analyses. However, FAO statistics indicate 9.7 tons, and official statistics report 10.4." In simple words, the transgenic sweet potato that was being imposed as the answer to Africa's food security was no better. His warning went unheard. Meanwhile, World Bank, USAID and Monsanto continue to sponsor her research project running for over 12 years now, involving 19 researchers, 16 of them with PhDs, something unusual for Africa. If only the $6 million that was incurred on her research project had been used for fighting hunger, more than six million impoverished Africans could have been fed adequately for as many as six years. No one is however keen to remove hunger. Not only the World Bank, USAID or the private companies, even agricultural scientists are looking forward to any and every possibility to latch on to hunger and malnutrition. The sweet potato debacle is the latest in the series of flops that have tumbled out from the GM industry laboratories, and that too in the name of ameliorating hunger and building food security. Ever since the days of the Flavr Savr tomato, the magic bullets of technology have failed to enthuse the farmers and the consumers alike. The 'golden rice', the protein-rich potato in India â€” protrato, and now the fall of the transgenic sweet potato in Africa, are all classic examples of the great exercise in public deception. At the same time, the GM industry finds itself in a terrible fix over reports that the cultivation of transgenic crops in the United States has actually led to an increase in the application and use of pesticides. This negates the only saving grace that the industry had so far used successfully used â€“ GM crops reduce the use of pesticides thereby leading not only to sustainable farming systems but also to a safe environment. Drawing on the official records of the US Department of Agriculture, Charles Benbrook of the Northwest Science and Environment Policy Centre at Idaho (USA), concludes that the planting of 55 million acres of genetically engineered (GE) corn, soybeans and cotton in the United States since 1996 has increased pesticide use by about 50 million pounds. Substantial increases in herbicide use on "herbicide tolerant" crops, especially soybeans, was cited as the main reason that accounted for the increase in pesticide use on GM crops compared to acres planted to conventional plant varieties. 'Herbicide tolerant' plants are genetically modified to ensure that those who grow these crops have no other option but to also the use the herbicides of the same companies. For the agribusiness companies, 'herbicide tolerant' crops are the sure means of profit security. That the American farmers have complied with the profit motive of the companies is quite obvious. Benbrook says that many farmers have had to spray incrementally more herbicides on GM crops in order to keep up with shifts in weeds toward tougher-to-control species, coupled with the emergence of genetic resistance in certain weed populations. For the developing countries, the implications of this study are enormous and of course serious. Agribusiness companies will exploit the small farmers pushing them more into a debt trap and at the same time do more damage to the environment and crop sustainability. Whether it is chemical pesticides or the pest-resistant GM crops, the effectiveness against the target pest lasts only for a couple of years. In case of cotton, for instance, the agribusiness industry is exhorting farmers to adopt Bt cotton, which has the inbuilt ability to produce a toxin that kills the pink bollworms. In India, in the very first year of commercial planting, Mahyco-Monsanto priced the seed four times than the existing price, thereby earning its pound of flesh in the very first year. The Bt gene has been further licensed to half a dozen companies from which a substantial royalty has also been drawn. The Bt cotton crop has, meanwhile, failed in the very first year of planting in large parts of the country. While the farmers suffered, the company that sold the seed has gone scot-free. By the time the farmers wake up to the damage done by the Bt crop to the environment as well as the economy, the seed companies will bring in the next generation transgenic. Agribusiness industry had done exactly the same in the past five decades, bringing in more potent chemicals each time the insect developed resistance to the pesticides. In the bargain, the number of problem insects that the farmers are now confronted with has multiplied to 70. In the 1960s, only seven crop pests worried the farmers. In three decades, the problem pests have multiplied 10 times. All over the world, Bt cotton is now losing its resistance to the pests as a result of which the pesticides consumption is going up. In China, where over 7 million hectares are under Bt cotton cultivation, pesticides usage has once again reverted back to almost what existed before its commercialization in 1999. Scientists are therefore refraining from conducting studies on pesticides saving four years later, knowing that such an analysis would be damming for the industry. For India, the failure of the GM crop technology elsewhere should serve as an eye-opener. We cannot afford to operate like the five blind men for the simple reason that Indian agriculture is faced with a severe crisis in sustainability. Already more than 16,000 farmers have committed suicide, and several thousand more end up each year selling their body organs. At the same time, 320 million continue to go hungry. The national priority should be to feed the hungry now rather than spend the same money for producing GM crops that feed the hunger of a handful of private companies. Devinder Sharma (Devinder Sharma is a New Delhi-based food and trade policy analyst. Among his recent works include two books: GATT to WTO: Seeds of Despair and In the Famine Trap.)     ]]> <![CDATA[Intermeshing innovations and enterprises]]> https://biospectrumindia.com/news/95/1393/intermeshing-innovations-and-enterprises.html https://biospectrumindia.com/news/95/1393/intermeshing-innovations-and-enterprises.html Thu, 12 Feb 2004 14:15:00 +0530 Continuing the theme of building an "Innovative India", Dr R A Mashelkar makes another strong case for creating strong linkages between innovators, entrepreneurs and financial investors. To encourage communities, it is necessary to scout, support, spawn and scale up the green grass root innovation to generate employment and use natural resources sustainably through linking of innovation, enterprise and investment. This requires building up adequate linkages with modern science and technology and market research institutions. In short, one needs new models of development, employment generation and conservation of natural resources. In this connection, one looks with hope to organizations like the Gujarat Grassroots Innovation Augmentation Network (GIAN). GIAN has attempted to set up a venture capital fund for small innovations providing for its linkage with R&D and scaling it up into viable enterprise. The National Innovation Foundation set up by the Government of India has launched several programmes to support and encourage grass root innovators and most importantly, to build the bridge between the grass root innovators and modern science. If we look at the scientific knowledge domain, we find that borderless science has already arrived. We see that discrete boundaries no longer exist between various natural sciences such as physics, chemistry, biology, mathematics, etc. Explosive advances in adjacent sciences are shaping up the future of core disciplines. New paradigms of "seamless sciences" and even "seamless engineering" are emerging. Take as a specific example, sub-disciplines such as inorganic chemistry, biological chemistry, organic chemistry and physical chemistry. The 1987 Nobel Prize winning work of Lehn, Cram and Pedersen led to the elucidation of molecular recognition and to the whole new area of supramolecular science and engineering. This work was entirely possible, because they made the boundaries between these four sub-disciplines vanish. Today, more than ever before, we not only need "borderless science" but also need "borderless thinking" for problem solving. Yet we find that we work and think in isolation. Let me illustrate this by taking up a problem that we encounter in our everyday life, namely mixing. Getting the right mix Mixing is a challenge in diverse disciplines. In the case of astrophysics, one is concerned about the mixing of the interior of stars. In mechanical engineering, it is combustion. In environmental sciences, we are concerned with mixing and dispersion in the atmosphere. Oceanography deals with mixing and dispersion in oceans. Chemical engineers are concerned with mixing in chemical reactors. Physiologists look at mixing in blood vessels. Bioengineers are interested in mixing and aeration in bioreactors. Geologists deal with mixing in the mantle of the earth. All these diverse mixing phenomena occur on diverse time and length scales, differing by several orders of magnitude. However, these disciplines rarely benefit from each other, and discovery and rediscovery of concepts and ideas is common place. There are many instances, where one is trying to gain understanding of a common problem. Mind Reader Consider the issue of a human mind itself. As was pointed out by P.N. Johnson Laird, since the second world war, scientists from different disciplines have turned to the study of the human mind. Computer scientists have tried to emulate its capacity for visual perception. Linguists have struggled with the puzzle of how children acquire language. Ethnologists have sought the innate roots of social behavior. Neuro-physiologists have begun to relate the function of nerve cells to complex perceptual and motor processes. Neurologists and neuropsychologists have used the pattern of competence and incompetence of the brain-damaged patients to elucidate the normal workings of the brain. Anthropologists have examined the conceptual structure of cultural practices to advance hypotheses about the basic principles of the mind. These days one meets engineers who work on speech perception, biologists who investigate the mental representation of spatial relations and physicists who want to understand consciousness. And, of course, psychologists continue to study perception, memory, thought and action. However, I have not seen a meeting of these computer scientists, linguists, neurophysiologists, anthropologists, engineers, and so on! Understanding of mind cannot be made possible without meeting of minds of all of them. As mentioned earlier, we need to fuse borders between several disciplines, including those in natural sciences and social sciences. For this, we need to change our culture. We need to ensure that our mind moves through diverse disciplines in a borderless way. The ability to correlate and link the non-obvious can lead to major breakthroughs. Management Chemistry Can you believe me, if I were to say that the supramolecular chemistry, which won the Nobel Prize in 1987, can be used to develop modern management structures? But this is precisely what is being done. Consider the issue of self-organization in molecular systems by using molecular recognition. The organization of molecules finally determines the structure, the properties and the functions. But is this not what we want in creating modern management structures to derive a specific end objective, or an organizational goal, or a function? Innovative efforts have been made recently to create flexible management structures by using the concepts of self-organization in chemical and biological systems. It is called a van der Waals model of Management. It is indeed fascinating that the chemistry of the non-covalent band, or supermolecular chemistry, is being used to create modern management systems. This is a splendid example of borderless thinking. We need more of it. An innovator is defined as one, who does not know that it cannot be done. Invariably, individuals who are unfamiliar with the discipline are also the ones who do not know that things cannot be done. Probably it is these individuals who will be able to give us conceptual breakthroughs through their unconventional thinking. Should we not, therefore, give away the habits of protecting our turf? Should we not organize unconventional fora, where only club members belonging to a single discipline do not meet but those in seemingly unrelated disciplines meet? We, in India need to seriously address several issues that hinder the creation of borderless minds and borderless thinking. They include our rigid academic curricula, our process of learning by rote, our rigid examination system based on a single correct answer, hierarchical structures in management, etc. Our systems promote inhibition and imitation rather than innovation. It is only in an environment, which fosters innovation that borderless minds can be formed and borderless thinking can flourish. Finally, we must recognize that innovation is not a unidimensional process. It is comparable to the intermeshing gears of a clock. The challenge before us is to make this intermeshing happen. It is only breaking up those walls and opening up those windows of mind will bring that fresh wind that will build the "Innovative India" of our dreams. R A Mashelkar, DG, CSIR ]]> <![CDATA[Tomorrow's focus]]> https://biospectrumindia.com/news/95/1330/tomorrows-focus.html https://biospectrumindia.com/news/95/1330/tomorrows-focus.html Thu, 12 Feb 2004 14:13:00 +0530 GUEST Biotechnology is the fastest growing applied science and is reckoned as the cutting edge of frontier technologies in the years to come. The 1980s ushered in a new era of industrial revolution shaped by two major technological advances. One is biotechnology based on cell technology and genetic engineering, and the other is information technology. Though biotechnology is very old, recent developments through new research, new techniques, new knowledge and new applications have opened up countless exciting opportunities. In fact, biotechnology at the moment is witnessing some breathtaking and mind-boggling developments. The breakthroughs are helping in curing many diseases both in humans and animals, developing products and processes never witnessed before, reducing the cost of production in traditional products, increasing agricultural production, productivity, quality, shelf-life etc. In the South-East Asian region, a variety of applications in this field are gaining ground at an impressive speed. Biotechnology is being applied for the production of value-added products (often pharmaceuticals), for export differentiation and to feed the increasing population. India too is emerging as an important player in this field. There are over 363 biotechnology organisations including 175 biotech industries in the country. The value of biotechnology products including conventional fermentation based microbial products produced in the country has been estimated at Rs 890 crore at present. Botech dversified Various sectors such as drugs and pharmaceuticals, food and agriculture, chemicals, energy and environment are harnessing biotechnology for deriving the benefits. The profound impact of biotech on the pharma industry is well known. The application of biotechnology in food and agriculture sector is less advanced compared to developments in pharmaceutical sector. Biotechnology has the potential to increase the productivity of world agriculture and is contributing actively towards it. It is contributing towards increased food production through higher yields and lower costs. New high value-added products have been developed to meet the needs of consumers and food processors. These products include agricultural inputs (seeds, herbicides, pesticides), veterinary diagnostics and therapeutics, food additives and food processing enzymes, more nutritious crops with improved food processing qualities. Similarly, new plants developed through selective breeding, cell culture techniques or through genetic engineering techniques can alter the nutritional content of fruit and vegetables and also increase consumer appeal. Genetic engineering is being used to develop temperature tolerant plants that can survive in warmer or cooler climates. Frost damage alone causes more than $14 billion of crop losses annually worldwide. Drought tolerance would enable cultivation in arid parts of the world. Water from the oceans could be used for irrigation if salt tolerant varieties could be cultivated. In all cases, the amount of land used for production could be greatly expanded. Biotech benefits The benefits of biotechnology are widespread. Medicine New and improved treatments for the diseases of heart and blood vessels, cancer and diabetes. Better and cheaper antibiotics. Vaccines to protect against viral diseases, such as hepatitis, influenza and rabies, and parasitic diseases, including malaria and sleeping sickness. Rapid tests that will aid doctors to make accurate diagnoses of many diseases. Agriculture Change in the productivity of crops by producing hardier plants. Extending growing seasons and geographical range. Reducing growth cycles to increase the frequency of multiple harvests. Developing strains resistant to pests, diseases, heat, frost, drought and flooding and increasing yields and minimising post-harvest waste. Creation of crops, which make their own fertilizers, with immense savings in costs to the farmers.  Herbicide tolerance, pathogen/pest resistance in plants. Plants, which can thrive on land that presently lies barren because the soil lacks water or is too salty. Substances that can speed the growth of farm animals. Vaccines that can protect the animals from foot and mouth disease. Cheaper forms of animal feed, consisting of microbes grown on waste materials. Improve the nutritional value and taste of products and increase their shelf life for easy transportation. Food processing Cutting energy costs. Speeding up processing time. Diversifying raw material needs. Reducing raw materials needs. Lowering waste disposal burden. Extending product shelf life. Modifying old products for new markets. Developing new markets and uses. Eliminating supply instability. Improving quality standards. Tissue culture Developing plant derived high value products. Mass propagation of uniform plants, precise and true-to-type free from pests and diseases. Increase productivity. Effecting changes in flowering seasons. Reducing the flowering periods substantially. Developing required colour in flowers. Increasing shelf life. Energy production Renewable fuels, including methane and hydrogen gases, and fuel alcohol for domestic and industrial use. Substances manufactured by microbes that will help to extract oil locked underground. Energy efficient alcohol technology The technology consists of a genetically modified yeast strain and associated fermentation and distillation parameters, which lead to the production of 10 to 12 percent alcohol. Engineering of corn and wheat to enable the plants to fix their own nitrogen could result in a potential savings of $4 billion annually in fertiliser costs. The development of varieties that are naturally resistant to pests and fungal pathogens offers opportunities to reduce the use of insecticides and fungicides in crop production. Biotechnology can be used to improve enzymes that are used extensively in the food industry as processing aids. Rapid and sensitive methods for the detection of pathogens, toxins or chemical residues, based on the development of DNA probes or monoclonal antibodies, could help to ensure the safety of the food supply. Biotechnology could provide new techniques for upgrading waste streams, improving utilisation of food processing by-products and decreasing the environmental impact of food processing waste. The food sector is the oldest user of biotechnology. Biotechnological processes were used first for food conversion. Breweries, bread manufacturers and the dairy industries (cheese, yoghurt) are still predominant in the food sector. Biotechnology can play a role in preventing losses during food processing in developing countries, when post-harvest losses of 10-20 percent of vegetables (some times reaching 40 to 50 percent) and 10-30 percent of tropical fruits are common. Adoption of biotechnology has cut energy costs and processing time, diversified and/or developed new markets for waste materials, extended product shelf life, modified old products for new markets or designed whole new products, eliminated supply instability and improved quality standards. Asia accounts for nearly 80 percent of the global production of aquaculture products, followed by Europe (10 percent), North America and Caribbean (5 percent), and Russia (3 percent). Of the total aquaculture production, finfish account for 50 percent, seaweeds 25 percent, molluscs 21 percent and crustaceans 4 percent. In view of the soaring world demand for fish, it appears that the natural harvesting techniques would not be able to meet the increasing demand but the biotechnology applications can make positive contribution to improve aquaculture yields. In the very long run, biotechnology may have a major impact in shifting the production of fuel and bulk chemicals away from reliance on non-renewable resources (e.g. oil) and toward renewable resources (e.g. biomass). This field appears to be limited, in part, because the international price of oil has remained too low to encourage investment in alternatives, and in part, because the chemical industry throughout the world has been restructured during the last 10 years, moving away from bulk chemical production and toward the production of speciality chemicals, pharmaceuticals, and agricultural products. Several biotechnology applications have been developed in the environment sector, which broadly includes pollution control, crop enhancement, pest control, mining, and microbial enhanced oil recovery. Biotech is contributing significantly to improve the quality of life. It is also offering many avenues to investors for setting up commercially viable ventures. But the success of biotechnology development in any country depends upon government support and encouragement, science base, capital base, and industrial base. It is therefore essential to ensue that these conditions prevail before biotechnology can render its economic and social rewards. Piyush Palkhiwala Piyush Palkhiwala is chairman and managing director-Maps (India) Limited           ]]> <![CDATA[Patent primer]]> https://biospectrumindia.com/news/95/2107/patent-primer.html https://biospectrumindia.com/news/95/2107/patent-primer.html Thu, 12 Feb 2004 14:11:00 +0530 LEGAL VIEW Patents were granted as early as the14th century. According to reports, Filippo Burnelleschi, the architect of Florence's remarkable cathedral won the world's first patent for conveying goods up to the Arno River. He divulged his invention only when the State of Italy gave him a monopoly for three years. Interestingly, Thomas Edison obtained more than 400 patents a year and about 1,093 patents in his lifetime! Therefore, patents as a vehicle of monopoly have been in existence for centuries, although the TRIPs has added momentum and brought it to the stage. In simple terms, a patent is a contract between a government and an inventor (patent seeker). In exchange for complete disclosure of the invention, the inventor is granted a monopolistic right to exclude members of the public from making, using, selling or importing the invention in a territory for a limited period. But for the patent protection, inventions would have been kept as secrets and innovative technologies would have died with the inventor. The objective of the patent laws is to encourage disclosure of inventions and also to protect the inventor from copycats trying to make a fast buck. Pharmaceutical patents The current law permits only process patents in case of pharmaceuticals and agro-chemicals in India. As for the products per se in these areas, it is possible to file applications and wait in the queue until 2005 for its examination and grant (also called "mailbox" provision). This rule applies to any pharmaceutical/agricultural products including isolated genes, proteins or pharmaceutical compositions based on those genes or proteins, a novel or new chemical entity/molecule used for diagnosis, treatment, mitigation or prevention of diseases in human beings or animals, etc. While the mailbox application for the product is being examined, it may be possible to apply and obtain Exclusive Marketing Rights (EMR), if the applicant meets one of the two following set of conditions: Filed a product patent application in India for the invention. Obtained patent rights to sell the product in a convention country. Obtained Drug Controller's permission to sell that product in India. Made an application for grant of exclusive marketing rights in India. Or Filed and obtained a process-patent in India post-January 1, 1995, Simultaneously filed product-patent application under mailbox provision in India. Obtained Drug Controller's approval to sell the product in India. Made an application for exclusive marketing rights. If the EMR applicant satisfies any one of the above set of conditions, he will be granted EMR for a period of five years from the date of grant till the product patent is granted/rejected, whichever is earlier. So far, at least 10 applications for exclusive marketing rights have been filed in India, of which a few applications were rejected on procedural grounds, and the rest of the applications are reportedly being processed. The EMR grantees include Novartis for Glivec and United Phosphorous. Plants, animals and methods of treatment In India, no patents are granted for plants and animals in whole or any part (including seeds, varieties and species), biological processes, methods of propagation of plants and animals. The list excludes microorganisms. Similarly, any medicinal, surgical, curative, prophylactic techniques for treatment of human beings or animals are not patentable. Hence, new surgical techniques, method of corneal transplant, cardiac surgery, method of treating cancer or any method that renders human beings free of diseases are not patentable in India. However, the above methods of treatment are patentable in a few other countries such as the US. One reason is perhaps that millions of people suffer from various diseases and granting monopolistic rights in this field may confine the already expensive medical facilities to the rich alone. Another reason is that Article 27 of the TRIPs Agreement itself gives countries the option not to grant patents for methods of medical treatment. Hence, even after 2005, it is possible that these methods may not be eligible for patent protection. However, methods that do not "treat humans" are patentable: e.g., methods for killing bacteria, treating a dead body, preserving dead bodies, mummification and producing artificial limbs. Also patentable are prosthetic devices, pacemakers, implants, artificial limbs and contraceptive devices. In countries around the globe, especially the US, the position is radically different. It may come as a surprise that as far back as 1873, Louis Pasteur received a US patent for yeast "free from organic germs or disease." Till the 1980s, the US was conservative in granting patents to living organisms. The floodgates were opened by the landmark case of Anand Chakrabarty, which involved a bacterium genetically engineered to degrade crude oil. In 1980, the US Supreme Court clearly stated that new microorganisms not found in nature, such as Chakrabarty's bacterium, were patentable. In the case of Ex-parte Allen, the question that arose was: if microorganisms are okay, what about multi-cellular animals? The case involved a new kind of "polyploid" sterile oyster that had an extra set of chromosomes, which was edible all year round because it did not reproduce and waste body mass in that activity. The court ruled in the affirmative. No patent issued for this invention since the technique was in the public domain. Following this invention in 1988, Philip Leder and Timothy Stewart were granted a patent for Harvard mouse, which was genetically engineered to serve as model for study of cancer. Stem cell Stem cell research is an emerging field, wherein Indian Institutions such as National Centre for Biological Sciences, Reliance Life Sciences and Centre for Cellular and Molecular Biology, Hyderabad have reportedly developed stem cell lines which may be of potential use to the National Institute of Health, USA. Neither Indian laws nor government policies prohibit research on stem cells or use of embryos or foetuses. No patents have been granted so far in India in this field since the field is nascent and growing. Although difficult, it may be possible to obtain patent protection for novel stem cell lines and artificial organs generated through stem cell research. In fact, an Indian doctor developed an in vivo method of regenerating organs within the human and animal body using a person's own baby stem cells and won two US patents. Microorganisms Under the current law, microorganisms per se in its natural state of existence would not be patentable, as it would qualify as a "discovery". No new and useful genetically modified and mutant microorganisms may claim patent protection. Such organisms should be adequately described and their source properly indicated in the patent application. The organism may be deposited at an international depository. The Microbial Type Culture Collection & Gene Bank (MTCC), Chandigarh, India having acquired the status of an international depository facilitates such deposit. Thus, the scope of patentable subject matter is vast and incapable of being captured in a few words or sentences. Research, like the indefinite sky is beyond human imagination. Let's try to make the most of the grain of sand at hand. As Thomas Alva Edison said: "Verily a pioneer has to get his justice in the same way that a florist gets bouquets from century plants." What can be patented? What cannot be patented? In India, the patent system is governed by the Patent Act 1970 (as amended in 1999 and 2002). According to the Act, an invention, which is novel, involves an inventive step and has industrial application, i.e., practical use, may be patented. "Novel" means the invention must be new, not, published or used by any one in the world. "Inventive step" is that feature of the invention that makes a skilled addressee sit up to say "Ah! I couldn't have thought of it!" In other words, any invention, which is new, inventive and useful may be patented and that includes improvements. Now, everything that is new and useful cannot be patented, since the patent laws in every country invariably prescribe certain restrictions. The subject matter excluded from patent protection in India include discoveries; laws of nature, natural or physical phenomena, and abstract theories; computer programs per se, business methods; agricultural and horticultural methods; plants and animals, except microorganisms; traditional knowledge; presentation of information, scheme or rule or method of performing mental act, playing games; any invention relating to atomic energy; mere admixtures; discovery of a new property of a known substance. by Rajeshwari, K& S Partners: rajeshwari@knspartners.com Vimla Pinto, J Sagar Associates: vimla@jsalaw.com J Sagar Associates is a leading national full service law firm and K& S Partners is an IP focused law firm. Both the firms provide legal services to several domestic and international biotech clients. Henceforth senior people from these companies will write on the patent issue.   ]]> <![CDATA[CII predicts $1500 M biotech industry by 2007]]> https://biospectrumindia.com/news/95/1618/cii-predicts-1500-m-biotech-industry-by-2007.html https://biospectrumindia.com/news/95/1618/cii-predicts-1500-m-biotech-industry-by-2007.html Thu, 12 Feb 2004 14:10:00 +0530 CII predicts $1500 M biotech industry by 2007 The Biotech Committee of Confederation of Indian Industries (CII) strongly predicts the Indian biotech industry to be worth $750 million by 2005, though the same in 2002 was $150 million only. The industry would reach $1,500 million by the end of 2007, the report said. Raising the challenges ahead of BT industry in India, CII mentioned in its report that upgradation of toxicological labs, GMP certified facilities, import of animals for testing, and incentives for clinical research are desperately required. "Venture capital and investment, regulatory issues and mapping human resource requirementâ€“synergy between industry's needs and government's efforts are some areas that needs to be upgraded," urged Dr Sandhya Tewari, head, National Committee of Biotechnology, CII. She also suggested, that for the betterment of the growth rate in this area, the infrastructure needs have to be looked upon. Biotech tools handy for pharma: Joshi According to the Union HRD and science and technology minister, Dr Murli Manohar Joshi the Indian market would be soon flooded by a large number of new drugs and vaccines. "Some of them are in final phase for their clearance by regulatory authorities," the minister informed. Dr Joshi was addressing a gathering of captains and representatives of biotech industry in New Delhi. The biotechnology coupled with information technology is the new destination for industrial development with unlimited opportunities in this century, said Dr Joshi. He urged young entrepreneurs and researchers to venture into the field of biotech sector for their growth as well as welfare of the society. Dr Joshi said the centre's liberalized policy has boosted R&D, facilitating the growth of knowledge-based industry such as drugs and pharmaceuticals, IT, and BT. He also underlined the need to take into account controversial issues like genetic engineering. India, Malaysia getting closer CII and The Malacca Indian Chamber of Commerce & Industry (MICCI), Malaysia have tied up to promote Malacca and India as ideal investment destinations for their business community. The MoU was signed to tap the tremendous potential existing in biotechnology, pharmaceuticals, infrastructure and information technology sectors. Seed manufacturers will have to register their seeds Very soon the Government of India will come up with the seed law amendment bill, which will make mandatory for the seed manufacturers to register their seeds under the seed law. This was disclosed by the Union agriculture secretary, RCA Jain, who is part of the Task Force constituted by the Ministry of Agriculture, Government of India, to develop a forward looking policy of agricultural biotechnology in India. The Task Force headed by Prof. MS Swaminathan had met in Chennai for its last series of consultation where it interacted with the media to get their opinion and integrate them in a proposed policy. RCA Jain was responding to the existence of fake seeds in the market, like the illegal BT cottonseed, being manufactured by Gujarat based local company. Even though the hybrids used by this company are not approved by GEAC (Genetic Engineering Approval Committee), illegal seeds have been sold in large quantities. "As per the new seed law, manufacturers will have to register their seeds. Even if the company gets authorization by GEAC, they have to get certification under the Seed Law," remarked Jain. In yet another move, the government has plans to start 96 FM (Frequency Modulation) radio stations in the rural villages to spread the awareness on new technologies in agriculture and on Genetically Modified (GM) seeds and crops. The task force with Prof. Swaminathan as the Chairman has representatives from Biotechnology, Environment, Health and Commerce, Secretaries Agriculture, as well as eminent biotechnologist in India. "The bottomline of this Task Force is how to use new tools of genetics in an environmentally safe way to contribute to the sustainability of agricultural productivity in future," said Prof Swaminathan. The committee has set up five sub-groupsâ€”VC Chopra Committee, RCA Jain Committee, Mangla Roy Committee, Manju Sharma Committee and Dr Amita Patel Committee. The five committees will soon be submitting their reports and it is expected that the final report will be submitted in a month's time. East Germany is India's biotech gateway to Europe Lower wages, liberal labor laws and availability of skilled and trained personnel are the major plus points for Eastern Germany, a future destination for all biotechnology and manufacturing companies. Speaking at the "Eastern Germany: a gateway to Europe for Indian companies" at the 10th Partnership Summit, organized by CC, Horst Dietz, the president of the International Investment Council, Germany contended that East Germany has offered unique opportunities for biotech companies. Already over 300 life sciences related companies had taken roots in the region. They specialized in medical designs, tissue culturing, bioinformatics and protein technologies. Most of the Indian life science companies were looking at East Germany as their future destination for expansion. "The famous Chemical Triangle in Germany was well known the world over for its quality research and production. Seventy-two universities and teaching schools in the region rich with R&D facilities also provided a healthy labor management environment," he said and added that the most significant financial incentive offered was 35 percent grant against investment in Eastern Germany by any investor. In the last 10 years, 2000 companies from 40 countries have located their manufacturing units in Eastern Germany. India needs 50,000 professionals Indian contract or research services segment has a potential of harnessing 50,000 professionals per annum over the next five years with a revenue realization to the tune of $5 billion per annum, said Kiran Mazumdar Shaw, chairperson of Confederation of Indian Industry's National Task Force on Biotechnology. At present only 15,000 bio-scientists are engaged in the biotech sector. The R&D outsourcing market in pharmaceuticals and biotechnology is expected to grow to $18 billion in the next three years. Shaw noted that factors like pressure on big pharma to increase development capacity without increasing fixed costs, continuing time-to-market pressures and superior performance on time and quality by CROs will drive the outsourcing market in India. India currently has three million graduates, 700,000 postgraduates and 1500 Ph Ds qualify in the biosciences each year. "A research services model therefore has the potential of gainfully employing this valuable scientific human resource and generating revenues equivalent to $100,000 per scientist, " she said. Singapore seeks Indian hand Indian industry looks at Singapore for ventures capitalists. Singapore looks for joint ventures with Indian companies in healthcare, biotech, medicine, research and development, which are striving towards success. The visiting health and transport minister of Singapore Balaji Sadasivan to India stated this. Balaji Sadasivan indicated at the CII Partnership Summit in Hyderabad that India has reached commanding heights in a multitude of fields and it is about time that India and Singapore integrate to form the unparalleled biomedical-healthcare collaboration in the world. "Singapore is undergoing its 6th phase of development, which is driven by the knowledge industry. Today Singapore receives nearly two hundred thousand medical tourists annually. However, it aims to receive almost a million of them every year, considering the fact that ASEAN itself is home to 500 million people. Singapore can achieve these objectives very fast if it partners with India and the prior Singaporean experience proves the same," Sadasivan added. Sanmar's biotech arm: Bangalore Genei The future of biotech initiatives of the Chennai-based Sanmar Speciality Chemicals Ltd, which recently acquired Bangalore Genei Pvt Ltd, will depend of the growth of latter. MS Sekhar, managing director, Sanmar Speciality Chemicals Ltd said, "Our future plans in biotechnology will be driven by the growth plans of Bangalore Genei and their execution. The future plans are to penetrate into international markets as well as to develop new products and expand the contract research business. This will obviously call for additions to staff and investments in labs, for which we are adequately prepared. " Now it's the turn of DNA parks We have Information Technology parks. Biotechnology parks are coming up. Now it is the turn of the combination of twoâ€”Bio-IT parks, called DNA/Bioinformatics Park. The proposed DNA/Bioinformatics Park is an initiative of the Department of Information Technology (DIT) and ministry of communication and information technology (MCIT) to facilitate the export of Bio-IT solutions and attract foreign direct investment in the field of information technology and health sciences. "In India the Bio-IT market is pegged at $15 million, which is poised to grow to $120 million by 2006 against the total global market size of $25 billion that is growing at 20 percent annually," said Kamalkant Jaiswal, IT secretary, government of India. Addressing a gathering at "Pune's potential to be the knowledge capital of India" organized by TiE chapter of Pune, he said, "The government has already engaged a team of global consultants to identify the nature and scope of infrastructure and services that such a park could offer to its users/tenants. The consultants will advise the government on the adoption of global best practices and methodologies with respect to such initiatives and partner the government in identifying a suitable partner for public private development of the park. " CDISC to set up India chapter Clinical Data Interchange Standards Consortium (CDISC), USA, a non-profit organization committed to the development of clinical research organizations' standards world over is looking at setting up its chapter in India. Dr Chandresh Shah, director, business development and pharma practice, CDISC, who was in Pune to participate in a convention on clinical data management informed BioSpectrum that discussions are on. And coordinating committee for setting up the Indian chapter has been initiated. "It will take some time. But I am hopeful of an Indian chapter of CDISC in near future." CDISC is an open, multidisciplinary, organization committed to the development of industry standards to support the electronic acquisition, exchange, submission and archiving of clinical trials data and metadata for medical and biopharmaceutical product development. The mission of CDISC is to lead the development of global, vendor-neutral, platform independent standards to improve data quality and accelerate product development in the industry. Synchron has 36 bed facility Synchron Research Services Pvt Ltd, an Ahmedabad-based clinical research organization started as a small company by a group of pharmaceutical professionals in 1998, has the facilities for 36 beds with adequate recreation and dining facilities to participating volunteers. Shruti Shukla, senior manager, business development, Synchron said that the organization has been functioning with a set of detailed Standard Operating Procedures for all phase I-IV clinical trials and data management activities. Data management operations are completely validated as per the regulatory requirements. Having its own bioequivalence center in Ahmedabad, she said Synchron has tied up with Nizam's Institute of Medical Sciences, Hyderabad for conducting Phase I studies. Synchron has conducted more than 150 biostudies mainly for European and USA clients. Synchron is conducting phase III clinical studies of Covance in India, which are part of global trials. The company has set up state-of-art facilities at Bangalore, which looks after phase II to phase IV clinical studies, including Data Management and is fully equipped with necessary hardware and software including SAS, Dell Servers, Computer Systems. ACE offers CRO course For the first time the Academy for Clinical Excellence (ACE) is conducting a diploma course for professionals in clinical research. The courses will be conducted only on Sundays. And will run till August starting from February. Samyukta Ajay, director, ACE informed that the course is open for graduates in medicine, pharmacy, microbiology or any other science stream. The syllabus comprises six modules and a dissertation that will have to be completed over one year. The program on diploma has been developed and will be delivered by eminent clinical research professionals from pharmaceutical industries, CROs and academia. "We have also undertaken tailor made programs for three companies. Besides organizing courses at Mumbai we do conducted courses at Hyderabad and Ahmedabad. For basic courses the intake will be 60 and for advanced courses we stick to only 40," said Samyukta Ajay and added that due to traveling assignments in the clinical research, people might be opting for clinical data management. Thermo Electron growsThermo Electron grows Thermo Electron LLS India Pvt Ltd has increased the turnover of its Bioscience Technologies Division to Rs 24.96 crore from the last year's revenue of Rs.16.45 crore. Ajit Tamhane, director, sales and marketing, bioscience technologies, Thermo Electron LLS India Pvt Ltd, informed that during the year ended December 2003 the company sold 80 Microplate systems in Yemen, Saudi Arabia and Bangladesh. Briefing about the achievements of Thermo Electron LLS India in 2003, Tamhane said "We started offering a unique facility called customs bounded warehousing for instruments, to help us to supply the equipments to our customers in the scientific and clinical sector within 48 hours of receiving the order." Explaining about the strategy for the year Virendra Tipnis, managing director, said "After completion of warranty, Thermo Electron will be commencing a major maintenance contract with the second National AIDS Control Program to maintain 500 ELISA systems. We are committed to support all our customers not just for sales but most importantly excellent after sales support and this has developed confidence about Thermo's brand in them." C3i launches India operations New York-based C3i Inc announced the launch of its global operations center in Hyderabad. A service provider for customer management consulting, integration and ongoing support services to the life sciences industry, this is the company's first facility outside US. Set-up in a record time of three-and-a-half months, according to Joel Morse, CEO and Co-founder of C3i, good technical infrastructure and skilled labor pool available in Hyderabad made C3i choose Hyderabad over competing locations in Phillipines and Canada. "Our Hyderabad operations offer a great competitive advantage with a 24-hour support capability," said Michael Jakubiak, the company's global implementation director. He was elaborating on the cost advantage and the strategic decision to locate to Hyderabad. The BPO center set up essentially to support the sales force of its clients will start with Roche in India. In Vanenburg IT Park, the company has a 99-seater facility with the first batch of 50 analysts under training. "We will scale up pretty fast," informed Morse. According to him, with multi-million dollar deals in the next 18 month pipeline the company will increase its revenues by at least 50 per cent. And that's just half the story. "Re-engineering of existing C3i business will see hundreds of jobs moving to Hyderabad from other three C3i locations in New York and New Jersey," he said adding that by December 2004 C3i will be employing 300 people in India. The company currently has 500 people on its roll worldwide and delivers end-to-end seamless solution to over 30 pharmaceutical, biotechnology and products companies in North America. At its India center, along with handling the inbound calls the team will also assist in implementing the Siebel solutions for its new customers. Foundation laid for biotech incubator in Hyderabad Dr Murli Manohar Joshi, union minister for HRD, S&T and Ocean Development, laid the foundation stone for India's first biotechnology incubator in Hyderabad. Andhra Pradesh Chief Minister N Chandrababu Naidu, B Gopalakrishna Reddy, minister for SSI and biotechnology, Andhra Pradesh and Dr (Mrs) Manju Sharma, secretary, DBT, were present on the occasion. Dr Joshi remarked that Hyderabad was emerging as "incubator for incubators". Encouraged by the potential for growth of biotechnology based industries in Andhra Pradesh, DBT, the department of industries and commerce (Andhra Pradesh) and the Council of Scientific & Industrial Research (CSIR) have entered a strategic linkage to set-up a biotechnology incubator at Shapoorji Pallonji Biotech Park with an investment of Rs 23 crore. The incubator is expected to be fully operational within two years. The Indian Institute of Chemical Technology, Hyderabad would be establishing and commissioning the incubator. It will also source technologies from various national laboratories and other academic institutions. There are more than 25 biotechnology incubators in the world with USA, Canada, France, Germany, China, Japan and other European countries making effective use technology incubation concept. India has also entered this concept and the biotech incubator being located in SP Biotech Park will serve as an example for more such incubators in the future. "There is urgent need to set up biotech incubation centers in the country and the Genome Valley Biotech Incubation Center bridges this critical gap in the essential infrastructure for the growth and development of biotech sector," informed Naidu. Magene launches biotech learning programs â€¦ Hyderabad-based Magene Life Sciences Pvt Ltd launched an integrated, inter-disciplinary, corporate learning programme in biotechnology with the first batch from Sartorius India Pvt Ltd. "The basic course designed to include hands-on-training, GLP, and introduction to modern biotechnology aims for a holistic approach to biotechnology. A module has been designed to cover the basic tenets of the related areas like microbiology, cell biology, genetics, biochemistry, molecular biology, immunology, bioprocess engineering and tissue culture," said Gita Sharma, director & CSO of Magene Life Sciences Pvt Ltd. The course costs anywhere between Rs 30,000 to Rs 50,000 per head and forms a part of the survival strategy for the company. Magene is aiming to make its mark in the niche bioservices sector. It offers testing services for the companies, which have developed new molecules. With the lab capacity of testing 96 molecules at a time the company is focusing on generic protein therapeutics. "We have already developed two molecules to the pilot stage and will be taking them to pre-clinical trials in March this year subject to regulatory approvals," said Sharma. The product catering to cancer patients is likely to be launched in mid 2005. â€¦ to ink deals with three major drug companies According to Sharma, at least 30 odd products will be off patent in 2005 and the company is gearing up for developing a majority of these molecules. "By February, the company is likely to announce the closure of agreements with three major Indian drug companies for testing their molecules," said Sharma stating that Magene is in the final stages of negotiation. She added that the company will also be doing similar work for two US and one German company and in the event some IP is generated it will share the IPR with the outsourcing company. With customer acquisition in the final phases the promoters expect Magene to recover the investment of Rs 7 crore in its very first year of operation. However, the scaling up plan is underway requiring the doubling of existing investments, informed MP Chary, Magene Chairman. Chary is the angel promoter of the company. The company with the current manpower base of 26 scientists will also work in the area of new drug discovery. Dr Reddy's organizes international symposium Dr RA Mashelkar, director general, CSIR, inaugurated Pharmacophore 2004, an international symposium on the theme "Innovating Drugs: Emerging Perspectives". Pharmacophore 2004 was organized by Dr Reddy's Research Foundation (DRF) and sponsored by Dr Reddy's Laboratories. Over two hundred eminent scientists from across the scientific community of India attended the symposium to share ideas of mutual interest and to inspire young scientists and others in the Indian pharmaceutical industry to take to pharmaceutical drug discovery and research. Pharmacophore 2004 attended by about 150 delegates had a range of presentations on various issues in drug discovery. In his inaugural address, Mashelkar gave a hint of things to come. "Drug and pharma industry in India is set for restructuring," he said elaborating that it will be forward engineering that will work for the industry and not the reverse engineering as it worked in past. Mashelkar informed that they have submitted a report to the government for a new regulatory authority and it won't be long before it comes into existence. He called for patent literacy and said a scientific approach with good legal systems can help elevate the status of India in the global pharmaceuticals market and contain the problem of spurious drugs. "The bottomline is people should get quality medicines," he said. Millipore India rolls 1000th WPS The Lab Water Division of Millipore India Pvt Ltd had the unique distinction of rolling out its 1,000th Water Purification System (WPS) from its manufacturing facilities in Bangalore. The 1000th WPS is an Elix 10 UV model and will be installed by one of the leading pharma companies based in Hyderabad. The WPS range from Millipore Corp., the leaders in membrane and filtration tech-nology, finds diverse applications in the pharmaceutical, R&D, biotechnology, clinical and educational segments. Applications range from HPLC, GC-MS, PCR, 2D Electrophoresis, and ICPMS to sample preparation, equipment feed and glassware rinsing. The need for ultra pure water is critical in such applications as impurities in water can distort research results and QA/QC analysis in pharma companies. While 1,000 WPS have been rolled out from Millipore India's production facilities, the installed base is over 3,000 systems in India. Globally, its Elix and Milli-Q range of WPS have been installed across 300,000 labs. Millipore claims that its A10 version can remove impurities and total organic carbon contaminants to less than 5 particles per billion (ppb). Scientists develop oxalic acid-free tomatoes After creating protein-rich potato, It's time for tomatoes. A team of scientists has succeeded in producing tomatoes, which are free of oxalic acid, a compound that causes kidney stones at National Center for Plant Genome Research (NCPGR) New Delhi. Informing about the technology, Dr Shubra Chakrabarty, of National Center for Plant Genome Research (NCPGR), "The tomato was produced by incorporating a gene from an edible mushroom into the plant." She led the research. The centre has patented the mushroom gene and also plans to use the same technology to create "kesari" dal, which will be free of neurotoxin that causes nervous system disease in people who consume this dal, she said. Human beings cannot degrade oxalic acid present in many plants like tomatoes, spinach, groundnut and soybean. Oxalic acid reacts with calcium in the body and gets accumulated in the kidney causing stones, Chakrabarty said a session on the research work of young women scientists. The team isolated a gene "Oxalate Decarboxylase" from edible mushroom and transferred it to tomatoes, leading to production of oxalic acid free plants. The trials have been carried out for about three years and the team planned to present the proposal for its commercialization to regulatory bodies in about one year, Chakraborty said. Dabur's anti-cancer drug goes into Phase 2 Dabur Pharma is all set to embark Phase 2 clinical trials on its peptide-based anti-cancer molecule DRF 7295. The company recently got the approval of the Drug Controller-General of India for conducting the trials. As per the company's experience with this molecule in first phase of clinical trials, the results have been encouraging. And the company is targeting to complete the phase 2 trials within 12-24 months. Dabur has also completed the phase 1 trials on its new drug delivery system (NDDS) for Paclitaxel, an anti-cancer drug. The trial results regarding Paclitaxel nano particles have shown that the NDDS has good efficacy and safety profiles. Dabur is open to licensing the inventions out for further development and commercialization. Some leading pharma MNCs have shown primary interest in these candidate drugs. The company, however, is likely to defer licensing deals until the phase 2 trials are over, as it reckons that value addition in research would help it clinch more remunerative deals. Dr Reddys gears up for its Oncology product Dr Reddys Laboratories is gearing up to bring out its oncology product. According to Dr Uday Saxena, the company's Chief Scientific Officer its Oncology product DRF 1042 is in pre-clinical trials and the results of animal-testing are very promising. Saxena was speaking on the sidelines of Pharmacophore 2004 symposium (January16-17, 2004) the two-day event organized to celebrate the 10th year of Dr Reddy's Foundation. Saxena informed that the company's R&D spending has increased to Rs 165 crore against a mere Rs 6.5 crore as research budget in 1993 when the discovery research programme was initiated." NRCC picks Ocimum's Biotracker Ocimum Biosolutions announced that National Research Council of Canada (NRCC) has chosen Biotracker as its Lab Information Management System (LIMS) for their DNA sequencing facility at Halifax. Ocimum's CEO, Anuradha Acharya commented, "This sale represents an affirmation of Biotracker as one of the leading LIMS solutions in the world for the Pharmaceutical and Life Sciences community." NRCC is Government of Canada's premier organization for research and development. The IMB lab in Halifax where the solution will be deployed houses the most active DNA sequencing facility in Canada, with a steadily increasing capacity to generate and analyze sequence data. Biotracker is a multi-platform GLP compliant LIMS for the biotechnology and pharmaceutical industries. The software enables life sciences and pharmaceutical labs to keep an accurate track of samples, reagents, instruments, processes and output from the time these samples or resources are acquired right through to the final stage of research. ]]> <![CDATA[Aventis rejects hostile offer from Sanofi-Synthelabo]]> https://biospectrumindia.com/news/95/3897/aventis-rejects-hostile-offer-from-sanofi-synthelabo.html https://biospectrumindia.com/news/95/3897/aventis-rejects-hostile-offer-from-sanofi-synthelabo.html Thu, 12 Feb 2004 14:09:00 +0530 p>Aventis rejects hostile offer from Sanofi-Synthelabo Igor Landau,chairman, Aventis Aventis has been informed that Sanofi-Synthelabo submitted an unsolicited offer to take control of Aventis in January. The Aventis Management Board, led by chairman Igor Landau, emphasized that the offer, which was launched without any prior approach from Sanofi-Synthelabo, was of a hostile nature and did not take into account the wide range of risks associated with the move. Furthermore, the offer contained a premium of 3.6 percent over the last closing price of the Aventis share. Sanofi-Synthelabo had announced a share and cash offer on Aventis's shares. It is believed that the offer was to create the #1 pharmaceutical group in Europe, #3 in the world, with pro forma 2002 consolidated sales of Euro 25 billion in the core business and a strong direct presence in all major world markets. The new group would have been the third largest R&D budget in the industry, with close to 60 projects in late-stage clinical development (Phases II, III and life cycle management). The offer was approved unanimously by the Board of Directors of Sanofi-Synthelabo on 25 January 2004 and was fully supported by Total and L'Oreal, Sanofi-Synthelabo's principal shareholders. Thermo Electron acquires Jouan SA Thermo Electron Corp. has completed the acquisition of Jouan SA, a global supplier of equipment used by life science researchers in academic, pharmaceutical, biotech, and clinical markets to prepare and preserve laboratory samples. The acquisition was completed at $137 million in cash plus the assumption of approximately $8.8 million of consolidated net debt, subject to a post-closing balance sheet adjustment. "With the addition of Jouan, we can provide our laboratory customers with a more comprehensive range of sample preparation products, supported by a global sales and service network," said Marijn E Dekkers, president and CEO, Thermo Electron. "We welcome the Jouan employees into our organization, and are excited about the new opportunities that will come from combining our complementary technologies and market strengths," he said. A key player in high-tech instruments, Thermo Electron helps life science, laboratory, and industrial customers advance scientific knowledge, enable drug discovery, improve manufacturing processes, and protect people and the environment with instruments, scientific equipment and integrated software solutions. It helps scientists discover new drugs, understand the human beings genetic makeup, and diagnose illness and disease. Abbott to acquire TheraSense Abbott Laboratories has entered into an agreement with TheraSense to acquire all of the capital stock of TheraSense for $1.2 billion, net of cash currently held by TheraSense. The transaction is subject to all required approvals. Closing is expected during the second quarter of 2004. "The combination will create significant opportunities in research and development, as we progress toward helping people with diabetes through advancements in continuous blood glucose monitoring and future integrated systems." said W Mark Lortz, chairman, president and CEO, TheraSense. Abbott entered the blood glucose-monitoring field with the acquisition of MediSense in 1996. MediSense was the first company to commercialize biosensor technology and grew rapidly with its product, Precision QID. Today, MediSense continues to offer additional innovative products such as Precision Xtra, the first blood glucose monitor to offer ketone testing, and Precision PCx, a hand-held, point-of-care blood glucose monitoring system used in the hospital setting. TheraSense, based in Alameda, Calif., develops, manufactures and markets FreeStyle blood glucose self-monitoring systems, and is a leader in developing systems that feature a very small sample size, rapid test results and less painful testing. Edwards Lifesciences completes Percutaneous acquisition Michael A Mussallem, chairman and CEO, Edwards Lifesciences Leading heart valve company Edwards Lifesciences has completed its acquisition of Percutaneous Valve Technologies Inc. (PVT), a privately held medical-technology company based in Fort Lee, NJ with a subsidiary in Caesarea, Israel. Under the terms of the agreement, Edwards is paying the shareholders of PVT $125 million cash and an additional up to $30 million in payments upon the achievement of key milestones. "We are pleased at how smoothly this transaction has been completed," said Michael A Mussallem, Edwards' chairman and CEO. PVT was founded by Stanton Rowe and Stanley Rabinovich, the company's CEO and COO, respectively, along with Martin Leon, MD, president and CEO of the Cardiovascular Research Foundation in New York, and Alain Cribier, MD, chief of Cardiology of University Hospital in Rouen, France. PTC Therapeutics raises $35 million Stuart Peltz, president and CEO, PTC PTC Therapeutics Inc. has raised $35 million through a private placement of Series E Preferred Stock. CSFB Private Equity and HBM Bioventures led this round of financing. PTC is a privately held biopharmaceutical company applying its integrated RNA biology and chemistry platforms to discover and develop small molecule drugs. Stuart Peltz, president and CEO, PTC said, "Completing this round of financing with such experienced and prominent investors further validates PTC's approach and accomplishments to date. The proceeds of this round will support the clinical development of PTC124, which is on track for an IND submission in the second quarter of 2004, as well the continued advancement of several programs currently in lead optimization. We continue to make significant progress in advancing our preclinical drug candidates particularly in the oncology and antiviral areas, where programs have advanced very rapidly to late stage optimization with excellent activity in preclinical disease models." Cellular Genomics secures $22.3 M Cellular Genomics Inc. (CGI) has raised $22.3 million in the initial close of a Series C private equity financing. This Series C Round is being led by Lilly BioVentures and has been joined by new investors Coastview Capital and Emerging Technology Partners, as well as existing investors including Connecticut Innovations, Flagship Ventures, MPM Capital, and Vector Fund Management. The funds raised in this round will be used to advance its drug discovery programs in cancer, angiogenesis, and autoimmune/inflammatory diseases into clinical development and to achieve key clinical milestones. CGI is a privately held genomics based biopharmaceutical company that is pioneering an integrated chemical genetics platform (Analog Sensitive Kinase Allele, or ASKA, technology) to discover and develop kinase and other signal transduction inhibitors for multiple clinical indications. CGI has generated potent, selective lead candidates in three drug discovery and development programs in autoimmune and inflammatory disease, cancer, and angiogenesis that are advancing rapidly towards the clinic. Synta closes of $50 M financing Synta Pharmaceuticals Corp. secured $50 million private financing. Caxton Group, Gollust Management, Mountain Trail Investments, Duquesne Capital, Galleon Group, AIG SunAmerica, and other undisclosed institutional and individual investors, representing both new investors and existing investors, participated in this round. Since its inception in 1997, Synta has secured about $180 million. This financing enables Synta to accelerate the development of its three lead clinical programs in cancer and autoimmune disease, while maintaining investment in its promising earlier-stage product candidates. Synta is an emerging pharmaceutical company focused on discovering, developing, and commercializing breakthrough products for severe medical conditions. It has three products in clinical development. STA-5326 is a first-in-class, oral inhibitor of IL-12, a cytokine critical to the development of certain autoimmune diseases including rheumatoid arthritis, psoriasis, multiple sclerosis, and Crohn's disease. STA-4783 is a small molecule that selectively induces the expression of heat shock protein 70 (HSP70) on tumor cells, causing a strong immune-mediated attack on tumors. The compound has demonstrated broad anti-cancer activity in animals when used in combination with taxanes such as paclitaxel. STA-5312 is a novel small molecule anti-cancer agent that has demonstrated strong activity against a variety of chemotherapy resistant cancers in animals. STA-5312 is currently in Phase I clinical trials. Concurrent raises $15 M Concurrent Pharmaceuticals Inc., a privately held biopharmaceutical company, completed a Series B Preferred Stock financing totaling $15 million. Current investors Prospect Venture Partners, Venrock Associates and New Enterprise Associates led the financing and were joined by new investor Intel Capital, Intel's strategic investment program. In addition to the financing, Intel and Concurrent will apply machine-learning tools in the discovery and development of novel pharmaceuticals. Concurrent has created a unique computational drug discovery platform for rational drug design. "We are very pleased to be working with Intel to optimize our computational drug discovery capabilities and that Intel Capital is a new investor. Intel provides access to unparalleled computational sophistication. This financing provides the capital we need to continue the medicinal chemistry validation of our computational technologies. It also helps us accelerate the rapid preclinical development of our three novel, highly potent and selective renin inhibitor series. We believe renin inhibition will be an important pharmacological approach for hypertension, renal failure, and vascular diseases," said John Baldwin, president and Chief Scientific Officer, Concurrent. Burrill Life Sciences invested $211 M Burrill & Company announced that its Burrill Life Sciences Capital Fund closed the year with a total fund commitment of $211 million. "We're excited to have successfully completed our fund raising in a very difficult venture capital fund raising environment," commented G Steven Burrill, CEO, Burrill & Company, a San Francisco-based life sciences merchant bank. The Burrill Life Sciences Capital Fund invests in companies from biotechnology, therapeutics, diagnostics, pharmaceuticals, devices, and other related medical technologies to companies involved in wellness/nutraceuticals, agribio, environmental biotechnology and the industrial biotechnology world (biomaterials/bioprocess). It will make $5-15 million investments in each company and anticipates a portfolio of 20-40 companies, generally in A/B/C venture rounds.             ]]> <![CDATA[The opportunity space is in "r"&D]]> https://biospectrumindia.com/news/95/2079/the-opportunity-space-is-in-rd.html https://biospectrumindia.com/news/95/2079/the-opportunity-space-is-in-rd.html Thu, 12 Feb 2004 14:08:00 +0530 During a Biospora gathering in Bangalore, Dr Bala S Manian shared his thoughts on the biotech entrepreneurial opportunities in the India-US corridor. BioSpectrum captures his formulas. Dr Bala S Manian He is a successful life science entrepreneur transcending three decades, who founded (and/or co-founded) companies like Quantum Dot, Surromed, Entigen, Biometric Imaging, Lumisys, Molecular Dynamics and Digital Optics Corp. Dr Manian holds more than 30 patents, many of which have resulted in successful commercial products. In February 1999, the Academy of Motion Picture Arts and Sciences awarded a Technical Academy Award to him for advances in digital cinematography. He has a B Sc in Physics from the University of Madras, a MS in Applied Optics from the University of Rochester, and a PhD in mechanical engineering from Purdue University. Though he may have been a very successful serial entrepreneur outside he says he is a budding entrepreneur. He is still learning how to do business in India. "I am not a mechanical engineer but have a PhD in mechanical engineering. I am not a life scientist, but have patents and contribution in the life sciences sector. I am not part of the movie industry, yet received an Academy Award," said Dr Bala S Manian. The message there is Dr Manian succeeded as an entrepreneur because he focused on problem solving. "The entrepreneurial opportunities lie in new discoveries, technology translation and adapting new methodologies. It is about identifying and defining the 'unmet' need. Great ideas come in terms of problems to solve. And when an opportunity of unmet need comes, there is a monetary gain too. Problems have been solved by new discoveries, technology translation, and adapting new methodologies. This has been the basis for entrepreneurship. It is not taught, you learn it by living it." So what is the process? Focus on an opportunity space rather than on a specific technology or methodology. Focus on core strengths and assets. Focus and leverage available human capital, more than financial assets. People make companies. Focus on economic value proposition. Constantly question as to why us? Is it nice to have or have to "have"? The opportunity space Today, several diseases have become "orphaned" because the market is too small and the cost of developing solutions to address those needs is very high. There is a large unmet need to improve pharmaceutical R&D by (i) increasing the probability of success of drug development, (ii) decreasing the time to market, or (iii) reducing the cost of a given phase of drug discovery or development. So, It is about "un orphaning" compelling opportunities. Enabling faster R&D processes through access to a larger pool of skilled scientific resources at affordable costs. The message is faster, better, and cost efficient. Exploration of "out of the box" development methodologies. Exploration of alternative development methodologies. All by refreshing the costs or reducing the amount of risk capital. The opportunity space therefore in about small r and big D. Manufacturing and services are the two other big opportunities. The methodical look? Leveraging the inherent Indian strengths like those in medicinal chemistry and pharmacology and IT and statistics to the best possible extent. Besides India is a good base for developing new paradigms for clinical trials. So, ways â€¦ In development Assays for R&D Diagnostic assays for supporting clinical trials Extending and expanding assays on existing platforms. Therapeuticsâ€”Playing value arbitrage game In manufacturing In a manufacturing process, scaling up is more important than a matter of product. The process is the product. It is about process control. More so a biomolecule without a manufacturing process is like theory without an application. Research products Biopharmaceuticals Niche branded drugs under contract manufacturing model. Services Contract Research & Development Clinical trials Patient management services. (The future is about maintaining wellness and treating illness.) Pharmaceutical sales and marketing support services. Complexities and diversity of pharmaceutical need higher skilled detailing support. Apply process engineering principles along with application of robust evidence based with clinical trials. Why am I interested in India after 37 years? The US life sciences industry is in a state of transition. Flight of capital away from the industry Cost pressures are starting to limit innovation and growth. The US life sciences industry is under considerable pressure from a financial and operating point of view. The reason: Since the mid 1990s, pharma companies spent billions of dollars on early stage drug discovery technologies like combinatorial chemistry and genomics. This investment in technology has led to an increased number of potentially attractive drug targets and hit molecules, but did not translate into an increased number of new drugs. For example: pharmaceutical companies need to produce 2-3 new drugs per year to deliver on the earnings promised to the financial community, the top 20 pharmaceutical companies have only produced 0.5 new drugs per year in the last decade. The cost to produce a drug is approximately $800 million and takes 10-15 years to take to the market. Interestingly, 90 percent of drugs have revenues of less than $180 million, making it difficult to justify such a large R&D investment. So these represent unique opportunities to be tapped. Further, healthcare spending will rise in the coming years. With people living longer, the portion of the population over 65 years old is increasing substantially. This leads to increased pharmaceutical consumption. For example, in the US there are 65,000 centenarians, and this number is expected to grow to 1 million by 2050. All these indicate an enormous pressure on the costs and resources. Added to that people are concerned about good life. So the focus is on wellness and preventive care rather than illness and disease management. So India has a huge opportunity in BPO kind of services for patient and health care management. We can call it as the "IT-enabled bio services) As mentioned above, the global pharmaceutical and healthcare industry is in dire need for improvements from a cost, speed and productivity perspective. Creative solutions are likely to be needed in these cases, leading to the opportunities for India. Where are we today? The pace of new technology evolution is accelerating. But the duration of "technology life cycle" is declining. Boundaries between disciplines becoming fuzzier than ever and there in lies the opportunities. India can become an integral part of the life sciences industry just like how it did in the IT sector. Investment in developing India as a preferred destination for drug discovery and healthcare would create new opportunities and wealth. In the near term, outsourcing services (particularly where IT and life sciences intersect) will be an attractive opportunity for India. But making investments in value-added services and technology will lead to the creation of sustainable businesses. Ch. Srinivas Rao ]]> <![CDATA[Data Manager]]> https://biospectrumindia.com/news/95/1529/data-manager.html https://biospectrumindia.com/news/95/1529/data-manager.html Thu, 12 Feb 2004 13:51:00 +0530 India has all the ingredients to conduct clinical trials to tap the $70 billion opportunity in clinical trials and clinical data management system. Providing the right inputs for the subjects is very essential as is doing good trials. India promises to become a world center for testing new medicinesâ€“Economist, London, January 2000 India can capture approximately $1 billion worth of global clinical research spending by 2010â€”McKinsey 2002 Today India is identified as a major resource center for conducting clinical trails and data management servicesâ€”Applied Clinical Trials, February 2003 These are the testimonies to India's potential in clinical research services. If properly harnessed, the above gains could translate to make India an important clinical research organization (CRO) destination in the world, said Dr Satish Bhatia, president Wellquest Clinical Research. According to Shruti Shukla, senior manager, business development, Synchron Research Services Pvt Ltd, "We require at least another 20 CROs to meet the requirements of the internal and external clients. There exists no competition among the CROs." But the reality â€¦ "India has a potential to bring in $70 billion in clinical trials as a major industry. We have all the ingredients to conduct clinical trials and clinical data management system. Providing the right inputs for the subjects is very essential. Institutes decide to develop infrastructure that will help in developing manpower needed for the sector. The industry is finding it difficult in finding out the talents to carry out the drug discovery process and conducting clinical trials," said Prof. AS Kolaskar, vice chancellor, University of Pune. The Indian CRO industry The Indian CRO industry is small and fragmented but growing by 20 percent per annum. Many companies including the leading pharma firms are setting up CRO units. The companies already working in the field include Lamba Therapeutic, Synchron, ClinInvent, Quintiles, IGATE Clinical Research International, ClinWorld Inc, ICON Clinical Research, Vimta Labs, SIRO Clinpharma, Apothecaries Clinical Research Clingene. Many pharma companies like Ranbaxy, Novatis, Wellquest, Pfizer, Wockhardt, Dr Reddy's Labs, Panacea Biotec, Reliance Clinical Research Services, Lupin are also working on clinical research sector. IT companies such as Infosys, HCL Technologies, TCS, IBM India, and Persistent Systems are looking at the opportunities in clinical data management, a module in clinical research. A few CROs and pharma companies have established a track record of conformance to good clinical practices and good laboratory practices (GCP/GLP) guidelines by getting approvals by Europe, UK, MHRA, Latin America and US FDA in the last few years. The Indian CROs are currently poised for international recognitions and alliance. The CROs give the Indian medical fraternity a chance to participate in the international research programs and this brings latest advances in medicine to India. A solution exists in bridging the gap between academia and industry. Both have to work together. University of Pune recently conducted a symposium on clinical data management. It was the first step to know what's relevant and what is not. It was set to review the new skills, the changes to existing processes, the direct influence of international regulatory guidelines, and validation methodologies. Guljit Chaudhri, convenor of the symposium informed, "The symposium aimed to create a forum for European, Asian and US Life Sciences organizations and academia to interact, exchange, learn and implement the latest advances in clinical data management as per ICH-GCP standards. And we were looking at offering excellent opportunities for exchange of ideas and experience on the campus between participants and international practitioners and it was designed to reinforce the learning from the sessions, tutorials and work on case studies and to address common problems faced in every day situations." "Based on the response to the program we will come out with the tailor-made courses on clinical data management. It is only a beginning. We are also planning to conduct a few more symposiums to understand the needs and areas into which we should focus at before proceeding, " said Prof Kolaskar. It is not that there were no programs at all for training. The Academy for Clinical Excellence (ACE) is one such center based in Mumbai providing training in clinical research. It was set up in October 2002 at the Bombay College of Pharmacy through the initiative and financial contribution of Pfizer India Ltd. It is expected that Pfizer will be contributing to the tune of $100,000 for a period of five years for the development of the academy. Subsequently, the academy was opened up for industry collaboration and Suven Life Sciences Ltd of Hyderabad has become a partner of ACE by making a financial contribution. The academy is conceived, as a one-stop-shop for all training needs of all clinical research professionals in the country. Now it is offering post-graduate diploma in clinical research. The director of the academy Samyukta Ajay said, "The diploma program has been developed and will be delivered by eminent clinical research professionals from pharmaceutical industries, CROs and academia. We have trained over 400 candidates in CRO and also conducted tailor made courses to three companies. " Continuing Samyukta Ajay said, "Professionals are looking at clinical data management, one of the six modules of clinical research as a new avenue as clinical research needs a bit of travel for doing the trials". But what assumes significance now is that the government of Maharashtra has prepared a blue print to develop University of Pune as a Center of Excellence in biotechnology and making Mumbai as a CRO hub. The day is not far off when this dream will be realized. The University has begun well and is taking a pragmatic approach. Narayan Kulkarni "Academia's support is a key for industry's growth" Prof. AS Kolaskar, vice chancellor, University of Pune and member of the Biotechnology Task Force of Government of Maharashtra spoke to BioSpectrum about the initiatives taken by the university to introduce a course in clinical data management, an opportunity that every company is looking at. Excerpts: What motivated you to look at clinical data management as a new course? Looking at the opportunities, India can become a major hub for clinical trials in the world. We have enough biodiversity available here. Even people from different parts of the country stay here in Maharashtra particularly in the Mumbaiâ€“Pune belt. We have a very good hospital system. Many hospitals are interested to have a tie up with research organizations of the western world and many people are exposed to newer drugs and they want to do the clinical trials. What we require is a proper channel for collecting the data, organizing and analyzing the same. The problem we are facing is collection of data and how to organize it. Taking the consent of the volunteer is a must and that should be taken well in advance. Indians need a proper training in this sector. Today if we see, clinical data management is not included in any syllabus. Industry particularly pharmaceutical and Clinical Research Organizations (CRO), international organizations and foundations look at clinical data management in different approaches. Within and outside the country the environments are different. It needs to be put in an organized way. In the first phase we brought international experts to sensitize a topic like which practices are used to collect the data? How it can be organized and retried for the benefit of the human kind? As different sectors like information technology, pharmaceuticals, academia, research organizations are involved in this we want to interact closely with each other before formalizing the final and regular course. When did you get the idea to start a course in clinical data management? I got the idea while we were preparing the biotechnology policy of Government of Maharashtra that was launched in 2001. And started collecting data on the topic. We learnt that our strength lies in biodiversity, good English speaking people and good hospital infrastructure. We also discussed at the Biotech Commission meetings to put Maharashtra on the clinical hub of the world. As an educator it gives me an opportunity to look at clinical data management as a new course. However we can download the stuff from websites and design the course. But I am not looking at that. I feel downloading won't work. Therefore my focus is to develop a proper system that should support the industry. Do you have any fixed time frame for introducing the course? We have just finished one workshop. The next one will be after three months. Based on the support we get from the industry we will go for the third one. Then formulate the necessary course program as a long-term policy. As the course is to be well accepted by the industry we have to have a tie up with international certification agency like CIDSC. It shouldn't become another regular course. I am looking at making it purely a job-oriented course, which will give India a global advantage. We want to create a proper environment to provide the right knowledge to the candidate in clinical data management both in quality and quantity. When the programs of the university have been well accepted by the industry why are you looking for certification from an external agency? There is a predetermined mindset among the industry people. We don't want to try and break these mindsets and take some time in that. I don't want India to loose valuable time in developing proper environment for clinical data management program. But the question is how we can develop India as a hub for clinical trials? There are many professionals working individually in this sector. They have experience. But they don't have the infrastructure and certification. That is why Indians are not gaining acceptance in the international market. In clinical data management authentication is a key. What is the course design that you are looking at? Normally it is the academia, which takes the initiatives. My interest is to take an early edge in this sector after understanding the needs of the users. Be it manufacturers, CROs all should come together and say all we need is these things from academia. Therefore we had organized the international symposium on clinical data management in mid- December to bring together the people who are actually in the field and those who are looking at this as a new upcoming sector. The first workshop was to sensitize and to tell the industry what the university can do in this area? And how useful the program is? The second workshop should be a focused one, where we have to go in depth on each of the topics. We have to collect enough material and take the best suited. I am not in a position to hurriedly take decision by bringing some topics by selecting few from the US, UK and EU. It is a difficult task. The candidates need tailor-made courses. We can't give one course for every one. This is what Indian students are missing. Looking at the paying capability of the students and needs of the industry we are looking at short-term courses of 10-15 days, even part time courses. We have to look at various things. This can be done only when you know the candidates interests in such programs. Some times even 3-5 days certification program will help a lot for professionals. This is what US universities used to give the students as a package. This kind of flexibility is very much essential. We have to bring in such kind of flexibility in Indian education system. We can't continue with the old system of education, which is taking more time to shift to the new system. Seeing the changes that are taking place we have to do it now and it can't be postponed. Even for designing the course material. Should industry and academia partner? The support of the academia is very much essential for the growth of the industry. By creating a knowledge partnership between the industry and academia, students would get proper training and know the latest industry happenings. Otherwise students will find it difficult to enter the field. They have to given in depth training. Ours is the first university to get the R& D people to its list of faculty. This kind of reverse flow is key for the success of any program. It will create new linkage in the coming years. It is not the projects from the industry that are coming into India, but the knowledge partnership between industry and academia is going to take India ahead. We have to work together. Industry tie up will help to take up the load of the administrative system. This will help the academia and the industry will be benefited too.   Narayan Kulkarni ]]> <![CDATA[The secret of longevity]]> https://biospectrumindia.com/news/95/7568/the-secret-of-longevity.html https://biospectrumindia.com/news/95/7568/the-secret-of-longevity.html Thu, 12 Feb 2004 13:49:00 +0530 The secret of longevity "Eat less and live longer". This principle now has the backing of science. Latest research says that in order to lead a long and healthy life calorie intake needs to be reduced. Calorie restriction extends life span in a wide spectrum of organisms and has been shown to delay the onset or reduce the incidence of many age-related diseases, including cancer and diabetes. Shedding light on why drastically restricting calorie intake prolongs life span in some organisms, MIT researchers have reported that lowering the level of a common coenzyme activates an anti-aging gene in yeast. MIT Biology Professor Leonard P Guarente had earlier discovered that calorie restriction activates the silenced information regulator (SIR2) gene, which has the apparent ability to slow aging during the low-calorie diet. This gene makes a protein called Sir2, which is normally activated by the coenzyme molecule NAD. Guarente has shown that SIR2 is integrally tied to extending life span in yeast and in the roundworm. And significantly humans carry a similar gene. The present study probed how Sir2 is activated by calorie restriction. The researchers found that a coenzyme related to NAD, called NADH (nicotinamide adenine dinucleotide) inhibits Sir2 by blocking the action of NAD. During calorie restriction, levels of NADH decline in cells. This decrease in NADH allows NAD to better activate Sir2 and thereby extend life span. NADH is a coenzyme or enzyme helper is present in all living cells. (An enzyme is a protein that works like a catalyst in the body to prompt chemical changes; for instance, turning food into energy.) NADH, an activated form of the B vitamin niacin, helps produce energy through a series of chemical reactions in the cell. These findings have been reported in the January 1 issue of Genes and Development. "These findings provide a simple model for activation of Sir2 and extension of life span by calorie restriction," the researchers said. "Our findings suggest that the NAD/NADH ratio can serve a critical regulatory function, determining the life span of yeast mother cells. A reduction in this nucleotide activates Sir2 to extend the life span in calorie restriction." Guarente also found that respiration in yeast cells under calorie restriction goes up, not down. "A high respiration rate is intimately connected with calorie restriction in yeast," he said. "A high respiration rate activates SIR2. When respiration goes up, NADH goes down and SIR2 goes up. When SIR2 goes up, longevity happens." Though it still remains to be proved that whether these findings about yeast and NADH will relate to the extension of life span in mammals by calorie restriction. But all the same, no harm in going slow on calories. Targeted tumor treatment Taking cue from nature, scientists at the Weizmann Institute, Israel, have developed an innovative method for selectively killing cancer cells in mice using allicin, a chemical that occurs naturally in garlic. Allicin, which gives garlic its distinctive aroma and flavor, is as toxic as it is pungent. It has been shown to kill not only cancer cells but also the cells of disease-causing microbes and even healthy human body cells. Fortunately for our body's cells, allicin is highly unstable, and breaks down quickly once ingested. However, the rapid breakdown and undiscriminating toxicity presented twin hurdles to creating an allicin-based therapy. The key to scientists' success was the development of a unique, two-step system for delivering the cancer-wrecking chemical straight to the tumor cells. Scientists at the Weizmann Institute's biological chemistry department designed an ingenious delivery method that works with the pinpoint accuracy of a smart bomb. Their findings were reported in the December issue of Molecular Cancer Therapeutics. The method parallels the way allicin is synthesized in nature. Not present in whole, unbroken cloves of garlic, allicin is the product of a biochemical reaction between two substances stored apart in tiny, adjoining compartments within each clove. The two are an enzyme, alliinase, and a normally inert chemical called alliin. When the clove is damaged or broken, the membranes separating compartments are ruptured and rapid allicin production follows. The scientists realized that if doses of allicin could be repeatedly generated in this way at the site of the tumor, the highest concentration of the toxic molecules would be available for killing cancer cells. To zero in on the targeted tumor, scientists took advantage of the fact that most types of cancer cells exhibit distinctive receptors on their surfaces. An antibody that is "programmed" to recognize the tumor's characteristic receptor is chemically bound to the enzyme, alliinase. Injected into the bloodstream, the antibody seeks out these cells, and lodges itself and its passenger enzyme on the tumor cells. The scientists then inject the second component, alliin, at intervals. When it encounters the alliinase, the resulting reaction turns the normally inert alliin molecules into lethal allicin molecules, which penetrate and kill the tumor cells. Due to the precise delivery system, neighboring, healthy cells remain intact. Using this method, the team succeeded in blocking the growth of gastric tumors in mice. The scientists observed that the method could work for most types of cancer, as long as a specific antibody can be customized to recognize receptors unique to the cancer cells. The technique could prove invaluable for preventing metastasis following tumor surgery. Instant stem cells Extract stem cells from the bone marrow, dehydrate and pack them. Then wherever and whenever required, rip the packet open, mix water and use them! Just like the "ready to eat" instant foods, scientists are actively working towards perfecting the technique of creating instant stem cells. Cell biologists at University of California Davis have shown for the first time that mesenchymal stem cells (MSCs) can be dehydrated for storage and activated for possible use in future stem cell therapies. Researchers at the university are developing ways to desiccate and store mesenchymal stem cells (MSCs). These stem cells can be isolated from adult bone marrow and have the potential to produce bone, cartilage, muscle, fat, and even neural tissue. The hope is to use MSCs clinically for tissue engineering and regenerative medicine. However, this goal will be feasible only if MSCs are available in a form that is easily and reliably transported, stored and used. The Davis researchers proposed that desiccation might be the best approach, and tested ways to make a stable dry mesenchymal stem cell product. Ann Oliver and colleagues of Center for Biostabilization, University of California Davis, air-dried the stem cells until their water content was in the range of 17-25 percent. Remarkably, the desiccated cells maintained 20-50 percent viability, which is the highest viability ever achieved in cells desiccated to this degree, the researchers said. Strikingly, the dried and rehydrated cells were also metabolically active suggesting they are capable of cell division. Since mammalian cells need their water, and usually die when dehydrated, so to protect cells during dehydration, protective substances are delivered into the cells. Oliver and her team soaked the stem cells in an anti-freeze sugar called trehalose. This is a sugar found in extremely high concentrations in organisms that can naturally survive drying and is a protective compound. This is the first step in making stem cell therapy a practical reality. But a real breakthrough will be if 80-90 percent of the cells can be revived after several weeks on the shelf. This will make handling stem cells easier and take the scientists one step closer towards clinical MSC treatment.           ]]> <![CDATA[Pune's biotech offerings]]> https://biospectrumindia.com/news/95/2215/punes-biotech-offerings.html https://biospectrumindia.com/news/95/2215/punes-biotech-offerings.html Thu, 12 Feb 2004 13:47:00 +0530  The large biotechnology research community in Pune is cranking out a number of significant methods to effectively combat some of the most troublesome diseases facing the humanity. Pune has been known by a plethora of sobriquets. Popular among them: Queen of the Deccan, cultural capital of Maharashtra, pensioner's paradise and Oxford of the East. Pune is one of the historical cities of India with a glorious past, an innovative present and a promising future. The city has provided many social reformers, revolutionaries, political leaders, researchers, scientists, educationists and players. In the 21st century it is fast becoming one of the major hubs of industry and commerce in the country. It is a base for many research institutions of national and international repute. Presence of the institutions such as Agarkar Research Institute, National Institute of Virology, Therapeutic Drug Monitoring Laboratory, National Chemical laboratory, Bharati Vidhyapeeth's Institute of Environment Education and Research, C-DAC, National Aids Research Institute, Rajiv Gandhi Institute Information Technology and Biotechnology, Animal Diseases Investigations Laboratory, Hirabai Cowsaji Jahangir Medical Research Institute, Jahangir Hospital, King Edward Memorial Hospital, National Center for Cell Science, Sahyadri Laboratory and Haemotology Center have made Pune truly a center of excellence in research. There are also many private research organizations working towards developing newer technologies helpful for biotechnology and life sciences industries. The institutions are working mainly on basic research and only a few have products ready for commercial use. Validating the general trend, Dr G J Samadhanam, a director in the department of science and technology (DST) pointed out that a recent study conducted by AICTE showed only a few research papers of M Tech and PhD students of IITs and renowned institutions of north India were useful from commercialization angle in the last 10 years. Even the industry people have same view on the research being carried out at national institutions. However, to present the rich intellectual properties of Pune, the Pune chapter of The Indus Entrepreneurs (TiE) under the leadership of Pratima Kirloskar organized a daylong event with theme Pune's potential to be the knowledge capital of India". As the theme itself indicates Pune's knowledge potential, the event saw many speakers making presentations on the technologies being developed at different institutes. Kirloskar had short listed these technologies based on their commercial potential from over 100 research breakthroughs in these institutions. The new technologies showcased at the show include cancer tumor shrinkage, cancer marker, clot buster, vitamin B12 manufacturing, arsenic removal, bone grafting and ayurvedic treatment for AML. Besides there were some corporate presentations about their current projects such as molecular modeling software, algorithm for chemotherapy administration and MRI image enhancement and Ayursoft. Of these some are already patented technologies. The presentations were based on the basic research that may end up as frontier technologies to the industry. Bone Transplants Briefing on bone graft Dr Ramesh Sangle, consultant neurosurgeon, Jahangir Hospital said, "We have the facility to replace the bones through bone grafting. But still people like Shah Rukh Khan go to the US for bone grafting. Our hospital has a bone bank too." Continuing, he said, grafting carried out under scientific and physiological methods will reduce 50 percent of the surgery duration and also the cost. So far the Jahangir Hospital has conducted 89 operations involving bone replacement following bone loss due to disease or accidents have been carried out. Every year, at least a million Indians require artificial bone grafts with each import costing about Rs 40,000. The bone transplants from cadavers could reduce the cost by nearly 80 times. Arsenic Poisons Dr K M Paknikar of Agarkar Research Institute has developed a micro bacterium which can be used in the removal of arsenic from ground water. He said about 2700 villages in nine districts of West Bengal are affected with arsenic contamination. Over six million people are affected and 300,000 people are suffering due to arsenic contamination. Briefing about the salient features of micro bacterium, he said it will be economically viable, highly efficient, easy to operate and requires minimum power. The institute is planning to conduct field trials in March. Bio Vitamins Making a presentation on producing vitamin B 12 and allied compounds through biosynthesis, Dr Suresh Bhosale of Agarkar Research Institute said in addition to vitamin B 12, one will get methane (a good fuel) and Factor III (used in poultry feed industry) as by products. Even the yields are also very good. The method here uses anaerobic bacteria to synthesize vitamin B12 in large quantities. Early Cancer Detection The detection of cancer in the body is a difficult task. The detection of cancer itself will take time pushing the person to the last stages. Hence to detect the cancer at the early stages and at any part of the body Dr M B Sahasrabuddhe has come out with a technology called cancer tumor shrinkage. This will help to detect cancer in any part of the body and helps to treat the disease. It also helps to kill the multiplication of the cancer cells and to produce immune response against cancer. The cancer cells are immune to treatment for a short time ie for a period of 0-12 days. He said, "We have developed antigen to develop to respond to the immune system and to control multiplication of cancer cells," he said. Clot Buster Dr Sabita Dey of Agarkar Research Institute has developed a natural molecule with enormous medical potential in the area of clotting. The molecule is called as Actinokinase: a new clot buster. It was produced using an enzyme which is a non-pathogenic and non-allergic and has no effect on BP/pulse rate. It will reduce the clotting time to10 minutes against the normal clotting time of 20-30 minutes. She said this was an in house technology and was viable for commercialization. Besides, Dr Madhavi Aghashe, Dr C B Koppikar of Prashanti Cancer Treatment Care Mission and Dr Vinay G Vaidya of Scientific Application Center, Siemens Information Systems Ltd made presentations on cancer marker a patented technology, Ayurvedic treatment for AML and on algorithm for chemotherapy administration and MRI image enhancement software respectively. Dr Vinay Vaidya said that the technology developed at the Siemens Scientific Application Center on computerized drug scheduling system for chemotherapy helps to destroy unwanted cells with minimum damage to the normal cells. It is very effective to treatment. This system will reduce the number of trials. C-DAC's AyuSoft Center for Development of Advanced Computing (C-DAC), an internationally acclaimed R&D organization of India involved in the design, development and deployment of advanced Information Technology based solutions, along with Pune University's Department of Health sciences, Department of Ayurveda, Pune's Janaprobodhini and Bombay's Mind Technologies Pvt Ltd is developing AyuSoft. Briefing about the software Deepali Uppal said, AyuSoft is a decision support system offering a suite of applications like prakruti assessment, disease diagnostics software, diet and lifestyle advice, patient information management system. It also offers ayurveda knowledge database and ayurvedic encyclopedia. Uppal said AyuSoft offers a comprehensive system including framework for integrating end to end solutions ranging from diagnostic software to lifestyle advice tailored to individual needs, complex query analysis along with a data mining engine and a range of products from a desktop solution to an intranet to an internet solution applicable to local / global markets. In a nutshell, AyuSoft is a comprehensive, interactive and intelligent system focusing on knowledge repository and decision support VLife's Chemogenomics VLife Sciences, a recent start up company concentrating on life sciences research is working on the pre-clinical research space of the drug discovery cycle. "Our aim is to reduce the cycle time and improve the quality of leads, thus addressing the two major challenges of the present pharmaceutical industry," said Atul Aslekar, director, VLife Sciences.VLife has completely incubated and successfully developed two ready-to-use technologies â€” ChemGen and MDS â€” that are complementary to each other. ChemGen is the proprietary technology based on the novel computational approach towards Chemogenomics, which differs significantly from the traditional approach. It brings in lot of new advantages as well over the conventional methodology, in terms of quality of output, flexibility and speed of research. MDS is a software platform that integrates and speeds up the virtual experiments. It is a comprehensive set of research enabling modules that allows the researchers to work with better consistency in the defined research outline. HandyLab's handy biochip HandyLab Inc. is a US-based microfluidics startup company spun-out from technology developed at the University of Michigan during the late 1990s. The core HandyLab technology is one of the simplest embodiments of the so-called 'lab-on-a-chip' type technologies. Nikhil Phadke a senior scientist at HandyLab Inc said, "We have developed devices that are capable of performing virtually all of the operations carried out in a standard biochemistry or molecular biology laboratory, on a microfluidic chip, in an automated and extremely rapid manner and at a nanoliter scale. The cutting-edge technology is truly interdisciplinary and incorporates latest developments in the fields of chemical engineering, chemistry, material science, electronics, computer science, optics, biochemistry, and molecular biology." "Our first generation products are nucleic acid and protein based testing solutions designed to diagnose infectious diseases, hereditary diseases and detect adverse drug sensitivities. Due to the design of the system and method of manufacture, the devices are low-cost, highly portable and extremely adaptable. Furthermore due to the inherent nature of the system the devices provide highly accurate, critical diagnostic information in less than 30 minutes, " said Nikhil Phadke. This is only a sample of technologies being showcased at the event. There are many more under the process of development. What next after technology development? So it is very much essential to establish a continu- ous platform between the scientists and the industry. This tech show has offered many opportunities for the industry to look at the research being carried out by the organizations based at Pune. Narayan Kulkarni ]]> <![CDATA[Superstore of leather tech]]> https://biospectrumindia.com/news/95/7002/superstore-of-leather-tech.html https://biospectrumindia.com/news/95/7002/superstore-of-leather-tech.html Thu, 12 Feb 2004 13:15:00 +0530 CLRI is one of the premier R&D organizations in the country with a strong foundation in both basic and applied research in leather and allied sciences. A thoughtful investment. In the year 1996, the Apex Court declared the closure of 400 tanneries in Tamil Nadu citing serious environmental problems of tannery effluents. Nearly 148 scientists from the Central Leather Research Institute (CLRI) demonstrated cleaner leather process technologies in tanneries and undertook the responsibility of providing the know-how on plant pollution control measures. The result: today almost all the tanneries in Tamil Nadu have either established Effluent Treatment Plants (ETPs) or connected to the CETPs. The national gain in terms of saving chemicals, improvement in the quality of leather and cost reduction in treating the effluents have been enormous by way of adopting the cleaner process technologies. "Probably, this is one example of its kind in India where science really solved a national problem," remarked Dr T Ramasami, director, CLRI. Interestingly, the first bio-product from CLRI for processing of skin into leather was aborted. This happened in 1959, when the tanning industry was not tech-savvy, therefore there were no buyers for this product. Even though their first bio-product had to be aborted, that did not mark the sunset of their travail. CLRI has today emerged as one of the few laboratories in the world to recognize the value of biotechnology in leather research. Activities in the area of biotechnology in CLRI took a definite shape in 1990, when the department of biotechnology was formed. Since then the focus is in the areas of enzyme technology, in vivo and in vitro studies on connective tissue metabolism and in the development of plant and synthetic drugs for use in the animal models for myocardial infarction and arthritis. In addition, the department provides training in the above areas for carrying out PhD, M Tech and MS Programs of the University of Madras, Anna University, BITS and other universities. On 31 January 2004, the first full-scale commercial product for the removal of hair in leather processing using enzymes is being launched by an Indian company with technology from CLRI, which has already got the international patent for this product and the concept. Technologies from CLRI Surgical sutures (commercialized in 1970s earning for CLRI substantial royalty and FICCI award Collagen sheet for burn dressing material (commercialized in 1996) A range of Collagen based biomedical products (commercialized since 2001) A series of enzyme formulations for applications in leather processing (in commercial use for more than two decades) Auto skin grafts based on epidermal cultures Maxibloc (bone implants), pet food (from slaughter house by products) Wound healing support systems (herbal and molecular systems) Bio active peptides for cardio vascular functions Bioprocessing of leather Patents and Inventions A process for the production of immobilized pancreatic enzyme product for use in leather manufacture: R Puvanakrishnan, SM Bose and SC Dhar, Indian Patent No.151088 (1980) A process for the preparation of a terminally protected tetrapeptide derivative exhibiting in vitro inhibition of platelet aggregation and antimicrobial activity: CV Ramesh, R Jayakumar, NR Kamini and R Puvanakrishnan, Indian Patent No.185761 Granted November 2001. A process for the synthesis of a novel dipeptide derivative exhibiting in vitro fibrinolytic activity: CV Ramesh, R Jayakumar and R Puvanakrishnan, Indian Patent No.185766 Granted November 2001 A process for the production of a novel lipase: C Hemachander, R Boopathy Naidu and R Puvanakrishnan, Indian Patent No.1555 DEL 99 An improved process for the production of stable lipase: NR Kamini, J Geraldine Sandana Mala, D Raghunatha Rao and R Puvanakrishnan, Indian Patent No. 1556 DEL 99 A process for the preparation of alkaline protease and its eco-friendly application in the pretanning processes of leather manufacture. CLRI â€“ NCL Joint Patent , Indian Patent Application No. 159 DEL 2002 A process for the preparation of alkaline protease: CLRI â€“ NCL Joint Patent (US Patent), Application No. 10/095428 (2002) The launch of the product will coincide with the 38th Leather Research Industry Get-Together (LEGRIG) in Chennai. This is an annual event held in Chennai from 31 January to 4 February, jointly by Indian Trade Promotion Organization (ITPO), with technology support and theme from CLRI. This year LEGRIG will have the theme "Paradigms in Leather Production", where the focus will be on the paradigm shift required in the way the finished leather is bring produced, with the tannery sector as the area of focus. Tracing back CLRI was formed in 1948, when 99 percent of India's export was raw hide (bigger animal skin) and raw skin. The planners of India decided to convert raw material into finished product. This meant the need of technology. Therefore, CLRI was founded to develop an internal strength in the country to generate, assimilate and innovate technologies for the leather sector. Today 60 percent of the leather industry in India is being manned and managed by the alumni of CLRI. In the words of Dr Ramasami, "We get the hide from the animal, where as the animals are found in the villages and the finished product goes to global market. Initially the weaker section of the society did the leather processing, who were less informed. Today with the leather industry being dominated by the alumni from CLRI, they could successfully carry the technology along with them to their workplace." On this day CLRI is world's largest research institute for leather and it strives to marry leather to its diverse functions. In other words it plays as the supermarket for leather related technologies. Taking the biotech way The scientists in CLRI are working at replacing bio-chemicals in leather processing with biological catalyst. Nature, the International weekly journal of science made a special mention of their concept in their publication where they said: "Scientists in India are using biological catalysts like those in saliva to turn animal hide into leather. Their approach could be only half as polluting as chemical tanning techniques. Tanners have a poor environmental record â€¦ Today, leather-makers have cleaned up their act, but their 'dehairing' and 'fibre-opening' steps are still pretty noxious. After scraping the flesh off animal skins, tanners soak them in lime (calcium oxide) and sodium sulphide to remove hair. They then loosen up the hides' fibres to soften them, again with lime. Sodium sulphide produces foul-smelling gases; lime leaves a poisonous sludge. Enzymes are already being used for dehairing in some parts of the world. Now Jonnalagadda Raghava Rao and colleagues at the Central Leather Research Institute in Chennai have found enzymes to replace lime in the softening step, where a protein-carbohydrate blend called proteoglycan is stripped out of a hide to leave only a clean web of tangled fibres of the protein collagen. Amylases, akin to those in saliva that turn carbohydrates into their component sugars, break down proteoglycan as effectively as lime does, Rao and colleagues show. The researchers complete their amylase-treated hides conventionally, soaking them in chemical or vegetable tanning agents to stop them rotting. The hides are as soft as limed pelts, and look much the same under the microscope." Nisha Kurian "Our endeavor is to convert biological waste into high end products." - Dr Ramasami Dr T Ramasami, director, Central Leather Research Institute, is committed to the cause of science relating to technology, technology relating to manufacture and manufacture relating to society. His commitment to science and technology won him laurels on 26 January 2001 when he was conferred with "Padmashri", the National Civilian Award. But on close interaction with Dr Ramasami, one will realize that he is not just a scientist, but also a merchandiser, thinking on lines on how to sell technology. It was under his leadership that the biotechnology division of CLRI became more commercially linked and visible. "One need not just be a scientist, but also a business man." When he took charge as the Director of CLRI in 1996, he had vowed that they would have 70 percent market share in the fashion leather world with respect to color selection. Today CLRI or in other words India has 100 percent market share in forecasting leather and color trends. Besides being a scientist plus a businessman, Dr Ramasami is the owner of an innovative mind, who believes that Biotechnology is knowledge-driven manufacturing. And now he has made yet another covenant. "I want this institution to go bio-oriented though basically I am a chemist". But why bio? What is the scope you see in biotechnology? There is no escape from the application of biotechnology from meeting the swelling future material needs of mankind. Considering the amount of food consumption at the present level and the food required for the growing population, we require land. We have to produce food 20 times efficiently. That means we have a bulging need but less space. The only answer to this demand is biotechnology, where we can get landless irrigation, and produce food in the factories. That is to say industrial production of food to feed the mouth. But at the same time this is also not without danger. Mankind has been genetically designed to take natural food. So if you take genetically modified food, you will end up as another being. Biotechnology is knowledge driven manufacturing. Any manufacturing can be broken into four parts: Material driven manufacturing, market driven manufacturing, technology driven manufacturing and innovation and knowledge driven manufacturing. The Indian worker is basically innovative, that is why we succeeded in IT since it is knowledge driven. Similarly, I want this institute to go bio-oriented. How did biotechnology happen in CLRI? I would say, the conception took place in the Fifties, birth in Seventies, and high growth in Nineties. Now we are heading towards zero discharge. We are now putting up technology and application of science to gain high value products from biological waste. There is already one technology commercialized to generate electricity after bio-methanation. In fact from one of these wastes we have made dog biscuits, animal and poultry feeds, hair shampoo, amino acids, which are high value products. This stream of activity is done as a network of CSIR where four labs are involvedâ€”CLRI, Central Food Technology Research Institute (Mysore), CCMB (Hyderabad) and IMTECH (Chandigarh). When we convert animal hide into leather, half of it will go into the product and another half will go as biological waste. This poses solid waste and management problem. So our endeavor is to convert biological waste into high end products. But isn't your core area leather? Our core area is leather and we will maintain leadership in that. But these are directions on how applications find their way into human life and it is like consolidation of expertise in other applications. In our lab, we are working on a project where we are studying how chromium used in tanning industry affects the death of lymphocytes, which give humans immunity. In human body there is birth and death of cells. If that doesn't happen it will lead to some kind of disorder. But we found that some other chromium compound and not the one used in tanning affects the death of lymphocytes. This programmed death of cells is called Apoptosis. We are now working on this area. Now one would wonder why should we work on such an area. But my answer is if we understand that Apoptosis is related to avoidance of occupational health and safety, why not work on it? Similarly in tie-up with MV Diabetic Clinic we have developed a Foot Care Product for the diabetic patients. People, who suffer from diabetes, have no circulation in their feet. If they don't look after themselves they may hurt their feet, which may lead to amputation. So we have developed a foot wear for the diabetic patients, which will be sold along with the diabetic kit. What are your other activities in biotechnology? One of our approaches towards biotechnology is to make bio-medical products from biological material. And most of these bio-medical products are byproducts of slaughterhouses. We have already developed many such bio-medical products like the Collagen Sheet, which can be used to treat burns. It is a natural material, which will act like the Band-Aid by protecting the wound against infection, heals them and removes the scar. This can even be used for covering leprosy. Currently we have six products in this segment and we are accelerating in this area. Other products in this category are eye care products and drug control delivery system again based on Collagen. Our second stream of activity is to make a paradigm shift in leather processing by using biotechnology. Last year the Government of India and CSIR set up a project called New Millenium Indian Technology Leadership Initiative (NMITLI). Here we are looking at opportunities where India can provide pre-competitive leadership in technology world over, and Biotechnology for leather was selected as one of them. We have started this work in association with 11 institutesâ€”IISC, Bangalore; CDFD, Hyderabad; CCMB, Hyderabad; NCL, Pune; IMTECH, Chandigarh; CLRI; Madurai Kamraj University; Alagappa University-Karaikuddi; Delhi University; Pune University and SPIC Science Foundation. Besides, 40 scientists are also involved in this project. The basic idea is to go from bio-chemical to bioprocessing in leather processing. We have to come up with applications of biotechnology for development of products and processing, which will replace sodium sulphide and lime in the pre-tanning operations. Sodium sulphide is highly toxic and causes major problems to workers in this industry. Use of lime creates sludge problem. So we are in the process of developing enzymatic products from microbes to fully replace sodium sulphide and lime. What will be your future contribution? We have entered into collaboration with TICEL Biopark, where we will be managing the park's animal biotechnology and analytical laboratory. Also we will be giving technology for companies incubated in TICEL for any Collagen-base byproduct. A branch of CLRI is going to operate from TICEL.     ]]> <![CDATA[Leading biotech drugs and their biogenerics status]]> https://biospectrumindia.com/news/95/2429/leading-biotech-drugs-and-their-biogenerics-status.html https://biospectrumindia.com/news/95/2429/leading-biotech-drugs-and-their-biogenerics-status.html Thu, 12 Feb 2004 13:08:00 +0530 Leading biotech drugs and their biogenerics status       ]]> <![CDATA[BioPharma longs for scientists]]> https://biospectrumindia.com/news/95/1889/biopharma-longs-for-scientists.html https://biospectrumindia.com/news/95/1889/biopharma-longs-for-scientists.html Thu, 12 Feb 2004 13:03:00 +0530 With the focus shifting to R&D and manufacturing of biotech-based drugs, its good news for biotechnology professionals. Winds of change are blowing through the Indian pharmaceutical industry. More and more pharma companies are looking at biotech-based pharma products. Restructuring is the buzzword. Following news snippets in the last two months will give indications on the hiring-mart. Nicholas Piramal India Ltd, a BioSpectrum Top 20 company and one of the leading pharmaceutical healthcare companies in India, is expanding its operations and recruiting another 100 scientists. Torrent Pharma, an Ahmedabad-based pharma major is recruiting 100 scientists taking its total strength within the company from 190 to 290. Zydus Cadila, another Ahmedabad-based healthcare solutions company with a strong base of 200 scientists, is adding another 100 scientists to its team. Alembic Ltd, a Baroda-based pharma company, has planned to increase the number of scientists on its rolls from 100 to 250, Similarly, Cadila Pharmaceuticals plans to increase its strength from 150 to 200. The trend is completely in favor of increased activity in bio-pharma. The marked change in human resource development initiatives is not hard to comprehend. In view of the forthcoming products patents regime, pharma companies have identified R&D as one of the key growth drivers. With a high premium on R&D and many new avenues such as clinical research, contract research, developing new drug delivery systems and new chemical entities opening up before the Indian pharma companies, the demand for qualified trained professionals in related fields is growing. Not just the Indian companies, but several MNCs are looking at India to set shop to gain the cost, time, and the trained manpower advantage as R&D costs in their home countries are very high. Major Solution Providers  Bharat Biotech  Bharat Serums  Biological E  Haffkine Bio Pharmaceutical  Panacea, Pfizer  Serum Institute of India  Shantha Biotechnics  SmithKline Beecham  Wockhardt, Eli lilly  Bhat Biotech  Qualigens Diagnostics  Span Diagnostics  J Mitra & Co  xCyton Diagnosti Dr SD Ravetkar, senior director, Serum Institute of India, said, "The potential for Indian BioPharma segment is huge. With the implementation of WTO and patents regime in 2005, Indian companies would not be able to do backward engineering of the drugs, so they are focusing on in-house R&D. The growth prospects are bright as many contract research organizations are coming up. Besides, a large number of foreign pharma companies are setting their R&D divisions here." Serum Institute is one of the largest exporter of vaccines and immunobiologicals of the country with its products being exported to about 38 countries across the globe. "The sector calls for professionals from various fields as biopharma is the cocktail of so many facultiesâ€”microbiology, biochemistry, molecular biology, immunology, chemistry, biotechnology and more. It requires candidates with diverse qualificationsâ€”microbiologists for the manufacturing process, biochemists for the down stream processing, immunologists for animal trials, biotech engineers for bulk manufacturing processes or process standardizing, etc." he added. What are they looking for? Traditional pharmacology is increasingly being considered as the downstream processing of biotech-based pharma. With this change in focus, the requirements of pharma companies at the entry level are also changing. Besides, regular pharma graduates and postgraduates, the industry is looking towards MSc and PhD candidates possessing specialized knowledge. The field requires people trained in new technologies with specialized skills, like immunoblotting, protein/genome analysis, western blotting etc. And in today's scenario candidates possessing these skills are rare. The responsibility and specialization of the individual will depend on the process, which he or she is handlingâ€”fermentation technology, downstream processing, proteomics, genomics, etc. "We are looking at people with a good background in biotechnology, biochemistry, or microbiology. Some basic technical skill is a must. At the same time they should have good understanding and reasoning capabilities, in addition to good communication skills and the ability to understand scientific literature," said Dr Shama Bhat, chairman and managing director, Bhat Biotech, a nine year old Bangalore-based biotech company specializing in design development, manufacture and marketing of diagnostic test devices for various types of tests like hepatitis, pregnancy, HIV. Varaprasad Reddy, CMD, Shantha Biotechnics, further elaborated, "The biotech industry is a knowledge-intensive one and human resource is its prime asset and strength. Quite like the IT sector was in the early Nineties, the biotech sector too is witnessing a lot of hype leading to expectations and is definitely a sunrise sector for any job-seeker. Hence, there is demand for qualified and experienced personnel. For the R&D job seeker, what is needed is the right exposure to the scientific way of working and the mindset to experiment and innovate. And patience to see R&D translate into commercial success. For people wishing to enter into other functions like sales and marketing, it would be easier as experience in a good pharmaceutical or FMCG company backed by an MBA qualification would be good enough. Also doctors wishing to enter the corporate world can find opportunities in Clinical Trials and be responsible for conducting trials and regulatory approvals." Clearly R&D, manufacturing and production, and sales and marketing are the main job categories in the Biopharma field. The importance of R&D is obvious and proper manufacturing is equally important so as to confirm to the international standards of cGMP. Also since most of the products are targeted at the global markets, they should conform to the export specifications. According to Dr Ravetkar ideally the distribution of manpower in companies developing new biotech-based cures should be equal in both research and manufacturing. "The main thrust of most companies is towards these two, while marketing and sales form the smaller divisions. This is because at present this field being new, products being less, there is little competition. The main challenge is R&D and manufacturing of the product rather than marketing the product," he said. For companies dealing in the diagnostics market, marketing is an equally important field due to the higher number of products in this sector. For example in Bhat Biotech the distribution of employees across the categories is about 50 percent in research, 30 percent in production and 20 percent in marketing. How are companies recruiting? For recruiting candidates at the entry level, most companies advertise in the leading national dailies or in the careers/jobs section on their websites. After the resumes are received candidates are short-listed through one-to-one interviews or sometimes written tests followed by an interview. Some companies arrange for walk-in interviews or go for campus recruitment also. "We also go for campus recruitment in Pune University, Hyderabad University and Bombay University. In the interview we mainly consider the attitude of the student. There are three important points that we keep in mind while selecting candidates: their basic qualification, any additional courses they have done, which adds value like bioinformatics or courses in bioinstrumentation. And good project work," elaborated Dr Ravetkar. "Basically the students should possess a basic/fundamental science degree and then do some supportive course. We have found another efficient method of selectionâ€”by absorbing candidates who come to do their MSc dissertation projects at Serum Institute. This way we get to know the students better, work with them at close quarters and are thus are able to assess them better. Sometimes we have seen that though their (students) academic results are not very good but they have a flair for R&D and do good research work. Another important consideration is good communication ability and confidence in oneself." A common advice by pharma majors to aspiring candidates is to hone their skills. As, ironically on one side, the sector has a requirement of a large number of people and on the other hand there is an acute dearth of adequately trained students. Most of them do have a strong theoretical background but do not possess enough practical skills. Students need to gain hands-on experience in the new upcoming branches of science. It is not that companies are not willing to train but the cost of training in terms of time is high. On an average investing in human capital, i.e., training a fresh person requires about a year, which also many a times goes waste when they go for greener pastures. Thus a minimum work experience of two to three years is gaining priority and provides a crucial selection edge. Further, several of the leading companies believe that the science colleges should try and make their students the best just like the management colleges, which promote their students. Like management companies, they should also invite premier companies for campus recruitment. They should invest in training and guiding the students. The salaries of researchers in pharma companies are appropriate, merit based and have begun to reflect the growing demand for skilled people. "The PhDs get remuneration in the range of Rs 5 lakh and above per annum," said Reddy. The growth potential for employees is good, as it is a nascent industry. Generally employees who perform well are sent for technology development training programs both in the country and abroad, like Serum Institute sends its employees to the US and UK for training in cGMP and production techniques. As developing new biotech-based solutions has become the main focus area for the pharma companies the demand for the scientists is expected to continue to grow. The characteristics of this business as opposed to those in other biotech segments like bioagri and bioinformatics is different too. Reddy explained, "This business is highly capital-intensive and needs a lot of R&D focus. Since development times are higher for biotech products, the employees need to have focus and motivation as well as determination to see the product through to market. Also since regulatory framework is not very industry-friendly, a lot of effort is needed for clearances and approvals." Finally, there are no stereotypes in the biotech world, except for the desire to make an impact on the world of disease. Rolly Dureha Sample Portfolio Shantha Biotech employs people with a wide range of qualifications such as diplomas, MSc, MBA, M Tech, PhD in functions like research, manufacturing, quality assurance, clinical research, sales and marketing. Some sample posts and qualifications: Head, Protein Sciences PhD in protein chemistry/molecular biology/biochemistry. Over five years experience in industry. Manages a group of 6-10 scientists and research associates and have experience in managing all aspects of protein expression and purification for research use. Protein Expression and Refolding Scientist PhD or MS in biochemistry or related field. Pharmaceutical or biotech industry experience preferred. Experience in E. coli expression, refolding, or related research field. Experience in bacterial expression and isolation of inclusion bodies. Experience in refolding proteins from inclusion bodies. Basic bioinformatics skills for manipulating DNA and protein sequences. Basic skills in protein purification and characterization, machine operation of FPLC, HPLC and PAGE. A research associate is responsible for research and development in collaboration with others on projects. He/she makes detailed observations, analyzes data, and interprets results. Research associates prepare technical reports, summaries, protocols, and quantitative analyses. An incumbent maintains familiarity with current scientific literature and contributes to the process of a project within his or her scientific discipline, as well as investigating, creating, and developing new methods and technologies for project advancement. He/she may also be responsible for identifying patentable inventions and acting as principal investigator in conducting his or her own experiments. A quality control analyst is responsible for conducting routine and non-routine analysis of raw materials. He/she compiles data for documentation of test procedures and reports abnormalities. A quality control analyst also reviews data obtained for compliance with specifications and reports abnormalities. He/she revises and updates standard operating procedures and may perform special projects on analytical and instrument problem solving. An entry-level quality control analyst's position requires a Bachelor of Science degree in a scientific discipline or equivalent and a minimum of 0-2 years' experience in quality control systems. A clinical research associate is responsible for the design, planning, implementation, and overall direction of clinical research projects. He/she evaluates and analyzes clinical data and coordinates activities of associates to ensure compliance with protocol and overall clinical objectives. He/she may also travel to field sites to supervise and coordinate clinical studies. An entry-level clinical research associate position typically requires a bachelor of science, a registered nurse degree or equivalent, and a minimum of 0-2 years' clinical experience in medical research, nursing, or the pharmaceutical industry. Knowledge of regulatory requirements is also preferred. A clinical coordinator must be familiar with the scientific/investigative process. Expertise may be limited to a specific functional area. A clinical coordinator must have good communications skills, both written and oral. He/she must also have project team experience and a familiarity with standard computer applications. Responsibilities include coordinating the clinical development plan as outlined by the company or Clinical Department, defining objectives, strategy, and studies. The clinical coordinator must provide support for planning, including detailed effort estimates, scheduling, and critical path analysis. He/she must monitor clinical activities to identify issues, variances, and conflicts, and analyze and recommend solutions. A regulatory affairs specialist at the entry level, coordinates and prepares document packages for submission to regulatory agencies, internal audits, and inspections. He/she compiles all material required for submissions, license renewals, and annual registrations. An incumbent monitors and improves tracking and control systems and keeps abreast of regulatory procedures and changes. He/she may work with regulatory agencies and recommend strategies for earliest possible approvals of clinical trial applications.   Rolly Dureha ]]> <![CDATA[A global bio business forum- a curtain raiser]]> https://biospectrumindia.com/news/95/4589/a-global-bio-business-forum-a-curtain-raiser.html https://biospectrumindia.com/news/95/4589/a-global-bio-business-forum-a-curtain-raiser.html Thu, 12 Feb 2004 12:42:00 +0530 Starting from February 26, 2004, BioAsia 2004 will be the first biotech event of the year. Hyderabad plays host to the event. This is the inaugural biotech event of the AP Government and will be held at Hitex in Hyderabad till February 28, 2004. BioAsia 2004 is being promoted by the government of Andhra Pradesh and Genome Valley, Hyderabad, as a global bio business forum and is aimed to be an ideal platform for companies, government, thought leaders and technologists from across the globe to transact business; build global alliances and collaborations; showcase products and services; and network with industry leaders, research scientists and media analysts. Chairman of the biotech advisory committee Dr D Balasubramanian informed, "Bio Asia 2004 will consist of a tradeshow, a conference, a B2B forum, CEO Conclave and a knowledge pavilion." According to available information about 60 internationally acclaimed speakers are expected to participate in the event of which several key people like Prof. William Rutter, Dr RA Mashelkar, Dr MS Swaminathan and Dr Manju Sharma have confirmed participation. Dr Balasubramanian further added, "The idea is to promote this as Asia's biotech event and get most of the Asian countries to participate." Highlighting the countries that are already in the forefront of biotech he said, "China, Japan, Korea, Malaysia, Singapore, and India have already made big strides in different areas of biotechnology and now we need to share the experiences and collaborate to emerge stronger, faster." The BioAsia conference is stated to cover topics such as: Biotechnology in Asia: Partners in progress, Creative Out partnering: Building and managing partnerships for future growth, Vaccine Industry in Asia: A look at the growth perspective, Commercialization of GMOs: Incentives & Thrust areas/future directions and issues regarding GM Organisms, Building a successful biotech company in today's marketplace: Vital role of VC funding. "The B2B Forum at BioAsia will focus on investment opportunities in the bio pharmaceutical industry in India. Venture capitalists, financial institutions and other investors are widely expected to participate in this forum. The B2B Forum is scheduling one-to-one sessions between the different participants of the program. Delegations from Iowa, San Francisco, North Carolina, Israel, Singapore, Malaysia and Thailand have already confirmed their participation," added to BP Acharya, industries secretary, government of AP. BioAsia has many hopes to be fulfilled and demonstrate the newer trends. Biotech in AP Andhra Pradesh is the first state in the country to have an exclusive policy for biotechnology in the year 2001. Companies from the state have generated over Rs 200 crore in 2002-03. It has a specific department and secretary for biotech. Has a dedicated BT Park, Genome Valley. "Genome Valley" has be trade marked. Phase-II expansion on. Considering establishing The International Institute of Life Sciences in Hyderabad, involving the leading biotech and life sciences industries in the State. Is developing centers-of-excellence in different branches of biotechnology viz. for agri and veterinary biotechnology in Acharya NG Ranga University, an agribiotech incubator in ICRISAT, a marine resource development center in association with Andhra Pradesh University and a pharma biotech hub in SP Biotech Park & ICICI Knowledge Park in Genome Valley near to Hyderabad. Plans setting up a marine park near Visakhapatnam. Has over 75 biotech companies. DBT has announced setting up an incubation center with Rs 25 crore outlay. The state initiated APIDC Venture Capital Ltd, a joint venture between the Andhra Pradesh Industrial Development Corporation and Dynam Venture East of USA, which has been providing venture capital to biotech start-ups. It has also an integrated IPR facilitating cell at ICICI Knowledge Park established is association with CII. This is to cater to the growing demands of the industries in Andhra Pradesh for patent search and analysis, patentability advisory services, IPR awareness and training. Has entered into several MoUs with countries like Malaysia, Thailand, Canada, and the US. There are many startups and technologies in biotechnology. Matrix Laboratories, GVK Bio-Sciences, Bio-Serve Biotechnologies, Krebs Biochemicals, Indigene Pharma etc are a few start ups with their new technologies and international partners located in the Knowledge Park. The Biotech Park has companies like Genotex, KCP Biotech, Ocimum, Jasmine, Aktiva Biotech and Sandor. These are all startups with good promise. Many companies have anti-cancer and anti-AIDS technologies and products like diagnostic kits are being proposed to be manufactured in Hyderabad. Besides there are established companies like Indian Immunologicals, Shantha, Bharat, Biological E and Dr Reddy's who are working on real cutting edge biotech products. Is surrounded by leading institutions like IICT, CCMB and CDFRI. Strengthening the existing training and educational institutions in the state. Planning to set up one Marine Bioresources Development Center in Visakhapatnam. While an agribiotech incubator is coming up in ICRISAT campus, National Animal Resource Testing facility is being set up in collaboration with ICMR/NIN at Genome Valley. BioAsia 2004: Key features BioAsia, the inaugural biotech event of the Government of Andhra Pradesh, has so far managed to arouse a lot of interest among the scientists, biotech companies and students pursuing biotech courses. Prominent participants at the Tradeshow include: Genome Valley, Bio Valley (Malaysia), Sartorius, T Staines & Co, Trans Biotech, Sun Microsystems, TCS, Emergent Genetics, E&Y, Bharat Biotech, Government of Kerala, Pall Life Sciences, Monsanto, Mahindra Park, Shantha Biotech, Seed Association, Avesthagen, Fortune Biotech and Magene Life Sciences. At the International Conference of BioAsia 2004, speakers are represented from many countries including Switzerland, United Kingdom, United States of America, Singapore, Israel, Malaysia, Thailand, Canada, China, France, Australia and Taiwan. Conference Highlights Theme: "Bringing Asian and the Global Biotech Community together by bridging the development divide." The sessions include: Biotechnology in Asia: Partners in Progress Creative Out partnering: Building and Managing partnerships for future growth Knowledge Base in Biotechnology: Showcasing Indian Research in Biotechnology Vaccine Industry in Asia: A look at the growth perspective Commercialization of GMOs: Incentives & Thrust areas / Future directions and issues regarding GMOs Advances in Asian Marine Biotechnology: Commercial production of high-value marine products Stem cell research: Path breaking work in Asia Building a Successful Biotech Company in Today's Marketplace Successful Drug Development: Defining a development strategy that optimizes clinical and commercial value Asia's role in Bioinformatics: Challenges & Opportunities ahead Clinical Trials: An opportunity Some prominent speakers Prof. William Rutter Dr R A Mashelkar Prof. MS Swaminathan Dr Joel L Sussman Dr Stephen Unger Dr Vipin K Garg Dr Ravi Sodha Dr Khalid Islam Dr Rashmi Barbhaiya Prof. Rakesh Bhatnagar Dr Samir Bhattacharya Dr William R Morton Dr Gurinder Shahi Dr David Anderson Dr Bruce Whitelaw Dr Jean Pascal Berg Dr D Balasubramanian Dr Andreas Wicki Dr Jannie Tay Dr Avigdor Scherz Prof. Tan Tin Wee Dr NK Ganguly   ]]> <![CDATA[GEAC needs a make over]]> https://biospectrumindia.com/news/95/6805/geac-needs-a-make-over.html https://biospectrumindia.com/news/95/6805/geac-needs-a-make-over.html Fri, 09 Jan 2004 11:06:00 +0530 GEAC needs a make over It should fly sky high like other famous regulators By a legislative accident, the Genetic Engineering Approval Committee (GEAC) in the Ministry of Environment and Forests, became the apex regulatory agency for the biotechnology sector. It happened because the Environment Protection Act, 1986, appropriated the right to regulate the release into the environment any product containing a genetically modified organism. For nearly 16 years, this anomaly was not even noticed. Now that biotechnology is on the verge of becoming a major area of economic activity, the inadequate expertise of GEAC to handle complex biotech issues has come to the fore. There is unanimity in the biotech sector that GEAC has to be given a thorough make over so that it becomes a forward looking, scientifically equipped regulatory body with an independent profile. BioSpectrum provides a ringside view of the cataclysmic developments within the sector, which is shaping the strong demand for a regulator the biotechnology segment could be proud of. It was a packed auditorium at the sprawling India Habitat Center in the heart of New Delhi on November 27 to celebrate the 10th anniversary of Gene Campaign, led by the fiery activist Suman Sahai. An unassuming bureaucrat, DD Verma of the Indian Administrative Service (IAS) kept the 150-odd biotech industry stakeholders such as industry leaders, activists, journalists, members of Parliament and researchers spell bound for nearly 90 minutes. He and his colleague Ms Ranjini Warrier fielded dozens of questions flung at them from different corners with aplomb. It was a rare opportunity for the biotech community to interact intensively with two officials whose every word could make or mar the prospects of the emerging industry. Who are these bureaucrats? Both Verma, a joint secretary and Warrier, a director, were part of India's apex biotech regulatory agency, the Genetic Engineering Approval Committee (GEAC) attached to the Ministry of Environment and Forests (MoEF). And they had come straight from another quarterly meeting of the committee which in the morning had taken the controversial decision to ruffle an industry icon, Shantha Biotechnics, by ordering an inquiry into some clinical trial data of its Streptokinase drug. GEAC is one of India's most feared regulatory agencies. The mere mention of the name evokes strong reactions from a cross section of biotech players. Here is a sample of the reactions: "We have been urging the total revamp of GEAC, an agency that meets only once in three months and is under pressure to look into various issues ranging from the Taj corridor to biotechnology," thundered Shantha Biotechnnics chief Varaprasad Reddy to the media on November 28 in Hyderabad. "GEAC should be wound up. It has no business to exist because we don't need genetically engineered crops in this country," emphasized agriculture policy analyst, Devinder Sharma in New Delhi. Or as Suman Sahai spat out: "GEAC represents a totally degraded regulatory system. It is a farce." No doubt, GEAC has been under fire for nearly two years, particularly from April 2002 when it approved the first commercial use of the genetically modified (GM) product, the Bt cotton seeds. The cotton seeds contain a gene from the soil bacterium, Bacillus thuringiensis, which provides protection against a major cotton pest, bollworm. GEAC has been criticized by NGO activists for being too friendly with the biotech industry. On the other hand, the industry has been highly critical of the decision making process of the regulatory agency which took over seven years to clear the first Bt cotton seeds by Monsanto-Mahyco combine. And what both the opponents and supporters of GEAC agreed was that the agency needed to be more transparent, have a more scientific structure and consult all stakeholders. Perhaps, the public pressure had been too much on the regulatory agency. No wonder Verma tried to reach out to the people through that interaction with a cross section of the industry. Of course, Verma was batting for his boss, Meena Gupta, an additional secretary in the Ministry of Environment who is the fifth person to wear the hat of the chief of GEAC in 2003. This is, in fact, one of the major criticisms against the structure of GEAC. Ever since the Indian economy embarked on the liberalization path in 1991, the government had set up regulatory agencies with varying powers to offer a level playing field to all the players in sensitive sectors like financial markets (SEBI), telecom (TRAI), insurance (IRDA), nuclea r energy (AERB), power (CERC) to name a few. Even after over a decade of toying with independent regulatory structures, the results have been mixed. Except perhaps SEBI and IRDA, all the other regulators have faced considerable flak from the public. However, these agencies have never been criticized for the nebulous structure they work with. All of them have a defined structure, a lot of functional autonomy, are headed by a people with by and large proven expertise in their field with fixed tenures. The most unfortunate regulator in this case has been the GEAC. That is what has riled the industry more than anything else. Headed by bureaucrats with no fixed tenure and no defined membership, the GEAC has ambled along since 1995 without any focus. There are many reasons for this. Primarily, the policy makers have not given much attention to the biotechnology sector unlike other areas of economic activity. The other reason is that any change to a more scientific structure is being resisted by the bureaucracy (read IAS officers) who are loath to give up another parking place for their tribe in the dwindling age of government. "They (IAS) officers have grabbed yet another strictly technical post and will resist any attempt to reform the GEAC," confided a senior technocrat who has watched this IAS versus others tussle for supremacy in the government structures for over three decades. In fact, Verma and GEAC have added a red herring in recent months. Verma announced the induction of four scientists as permanent members of the GEAC. The GEAC will have a co-chairperson in Dr Sushil Sharma, former director of the CIMAP (Central Institute for Medicinal and Aromatic Plants), Lucknow. Three others scientistsâ€”Dr AK Bhatnagar of University of Delhi, Dr RP Sharma of Indian Agricultural Research Institute, New Delhi and Dr Subash Chand of IIT, Delhi. This may be an attempt to stall the move at the highest levels of the government to restructure the GEAC as many representations have reached the Prime Minister AB Vajpayee from the biotech industry and senior scientists. In fact, a proposal under consideration is the report by Prof. MS Swaminathan, the architect of India's Green Revolution in agriculture and the recipient of the First BioSpectrum Life Time Achievement Award. Prof. Swaminathan has recommended the setting up an apex regulatory agency called the Biotechnology Commission along the lines of the Space Commission or Atomic Energy Commission. Such a commission, Prof. Swaminathan said should be headed by a senior biotechnologist and have four or five full time members who are specialists is different segments that form part of biotechnology such as agriculture, health, informatics, biosafety, etc. The Biotechnology Commission could then set up permanent sub committees for each of the specialized areas to carry out full scale risk assessment and other tests on an on going basis. The proposed Biotechnology Commission should be an independent one with statutory powers to regulate the entire spectrum of the industry with appropriate punitive actions etc. Analysts feel that the induction of four scientists, for the first time, is an attempt by the bureaucracy to stall and buy time on the move to set up the Biotechnology Commission. There is widespread support for the setting up an independent, high power regulatory agency for biotechnology. "We need a regulatory regime which understands the technicalities involved in the use of genetically modified products. There should be no lethargy in its functioning and the delays in the clearance process should be reduced drastically," argued Pune-based Syngenta's vice president (projects) Dr G D Pimprikar. Syngenta, one of the world's leading plant biotech company, is in the process of seeking regulatory approval for commercialization of its cotton seed based on a new variety Vip gene. Based on the ease of the regulatory process, Syngenta plans to introduce its other blockbuster biotech products in the global pipeline in India too simultaneously. Currently, at least three major government agencies are involved in the clearance of biotechnology products in the health care and agriculture sectors. For vaccines and other health products using biotechnology, clearances have to be got from the Review Committee on Genetic Manipulation (RCGM) in the Department of Biotechnology first, then the clinical trials data have to validated by the Drug Controller General of India (DCGI) in the Ministry of Health and the final authority for approval is the GEAC. While even in the US, there is a multiplicity of regulatory agencies such as the Federal Drug Agency (FDA), the US Department of Agriculture (USDA) and the Environmental Protection Agency (EPA). However, these agencies work in very close coordination, unlike in India, and specific timelines for approval or rejection are part of the regulatory process. Helpless regulator The Ministry of Environment had earlier received various complaints that spurious Bt cotton saeeds are being produced and sold in Gujarat without the approval of the Genetic Engineering Approval Committee (GEAC) constituted under Rule 1989. In response, 10 packets of cotton seeds alleged to contain the Bt gene were forwarded to Central Institute of Cotton Research (CICR) for verification. The report of CICR confirms that cotton seeds which are being produced and sold in Gujarat, under the following brand names, have tested positive for the presence of Cry 1 Ac gene. The report inter alia quotes "We carried out PCR and ELISA tests on eight seeds from each of the packets. We would like to confirm the following results. The above hybrids have not been approved by the GEAC and therefore, production/sale/use of the above hybrids is a clear violation of the Rule 1989 and liable for punitive action under the Environment (Protection) Act, 1986." BioSpectrum adds: The threatened punitive action has yet to be initiated. The regulator is still "awaiting" a report from the Gujarat state government as agriculture is a state subject. SlNo. Brand Name Result Remarks 1 Brand name: Rakshak Positive F-1 seeds 2 Brand name: Virat Positive F-1 seeds 3   Brand name: Captain F-1 Hybrid Cotton Seeds. Positive F-1 seeds 4 Brand name: Research Hybrid Cotton F-1 (Tilak) Positive F-1 seeds 5 Brand name: Trishul (F1) Positive F-1 seeds 6 Brand name: Kavach F-1Hybrid Kapasâ€“151. Positive F-1 seeds 7 Brand name: Surakshaâ€“ Hybrid Cotton Seeds. Positive F-1 seeds 8 Brand name: Research Hybrid Cotton F-1. Positive F-1 seeds 9 Brand name: Krushi-357 Positive F-2 seeds/seed mix 10 Brand name: Sarthi Positive F-2 seeds "A single window clearance mechanism is the best for a country like ours," emphasized Dr SD Ravetkar, senior director, Serum Institute of India Ltd, Pune. Serum is one of the country's and the world's largest makers of a variety of vaccines. "The GEAC has to evaluate the existing regulatory systems and change its structure so that it can become one of the best regulatory agencies in the world." There is another strong reason to make GEAC a powerful, independent regulator. GEAC has so far approved only three hybrids of Bt cotton from Monsanto for cultivation in six statesâ€” Andhra Pradesh, Gujarat, Karnataka, Madhya Pradesh, Maharashtra and Tamil Naduâ€”after seven years of rigorous trials. In Gujarat, however, a local seed company, Navbharat Seeds, has sold large quantities of its own version of the Bt cotton. This has undercut Monsanto's Bt cotton hybrids on price and farmers have bought this because its performance was found to be better than the legally approved varieties. An industry insider explained that Navbharat could introduce the latest hybrids, as it did not have to undergo the time consuming regulatory process. And what has the regulator GEAC done to stop the illegal use of Bt cotton seeds? Nothing much. GEAC tested 10 randomly picked up samples of Bt cotton seeds being sold in Gujarat and found that eight of them had the unapproved Bt gene (See Box item on this). GEAC does not have the power to stop the proliferation of the illegal Bt cotton varieties. GEAC officials have threatened to take punitive actions under the Environment Protection Act, 1986. However, as agriculture is a state subject, punitive action against illegal seed sellers and users could be taken only by the state governments. GEAC has asked for a report from the state government and the industry does not expect much action on this front. What is worse is that biotechnology committees at the state and district levels to monitor the use of GM products, mandated under the EPA exist only in name and are almost dysfunctional. Certainly, GEAC has to change its methods to become an effective regulator. Part of the problem is caused by the working of the GEAC itself. M Prabhakar Rao, president of Hyderabad based Indian Seed Industry Association, suggested that GEAC should restrict itself to the approval of a particular gene technology such as Bt gene. "Once a gene is found to be safe, GEAC should approve its use in any of hybrids. There is no point in GEAC evaluating the performance of each and every variety of hybrids. In fact, this may be a violation of the Seeds act," Rao emphasized. Syngenta's Pimprikar too supports this. "GEAC should restrict itself to the approval of a gene. After that leave it to the breeders to choose which hybrids to insert them. Beyond that it is a commercial decision. No breeder would use the technology in an inappropriate hybrid as it could lead to commercial failure," he added. Another major demand of the industry is the harmonization of the different laws such as Seeds Act, EPA, Drugs and Cosmetics Act, Prevention of Food Adulteration, etc. so that companies need not run from pillar to post to comply with unwanted, intricate provisions of these legislations. Every one is hopeful that at least in 2004, realizing the potential of biotechnology to be another engine of growth for the Indian economy, the government would act swiftly to revamp the structure of GEAC. Serious practitioners of biotech have been discussing informally the potential names of persons who should head the revamped regulatory agency. There is almost an unwritten consensus that the best person to head the new look regulatory agency is Prof. MS Swaminathan. The living legend would be able to give the regulatory agency immense prestige, clout and also the moral authority to bring about a rapid transformation of the biotechnology sector. Industry would also be very happy if Prof. G Padmanabhan, former director of Indian Institute of Science is made the agency's co-chairperson. Between them, these two eminent scientists possess the best of the knowledge on agriculture and health care issues. There is also a section of the industry which feels that if the government is averse to bringing in outsiders to head the agency, the GEAC should taken out of the purview of the Ministry of Environment and attached to the Council of Scientific and Industrial Research (CSIR) headed by the charismatic scientist Dr RA Mashelkar. Or at least the regulatory agency should be moved to the DBT and its secretary, Dr Manju Sharma should head it. The biotechnology industry is waiting for a quick decision, which should bring more clarity, credibility and single-mindedness to the pursuit of biotech boom. N Suresh ]]> <![CDATA[Invitrogen to acquire BioReliance]]> https://biospectrumindia.com/news/95/7443/invitrogen-to-acquire-bioreliance.html https://biospectrumindia.com/news/95/7443/invitrogen-to-acquire-bioreliance.html Thu, 08 Jan 2004 18:11:00 +0530 Invitrogen to acquire BioReliance Invitrogen Corp. and BioReliance Corp. signed a definitive agreement under which Invitrogen will acquire BioReliance in a transaction estimated at approximately $500 million including the assumption of approximately $70 million in debt. Under the terms of the agreement, Invitrogen will make a cash tender offer of $48 per BioReliance share. BioReliance is a leading Contract Service Organization (CSO) providing testing, development and manufacturing services for biologic-based drugs to biotechnology and pharmaceutical companies worldwide. "BioReliance helps us expand our already strong position in the bioproduction space and enables new opportunities with our large biotech and pharmaceutical customers," said Gregory T Lucier, president and CEO, Invitrogen. "Invitrogen's cell culture and bioproduction capabilities are well-known throughout drug development," said Capers W McDonald, president and CEO, BioReliance. Upon completion of the acquisition, BioReliance will become a part of Invitrogen's bioproduction business segment and, retaining its name, will focus both on its current line of services and on new developments that draw on both services and technology needed to improve drug development. Barr to acquire assets of Endeavor Barr Laboratories Inc. has signed an asset purchase agreement with Endeavor Pharmaceuticals to purchase substantially all the assets of Endeavor Pharmaceuticals. In the transaction, Barr will acquire the New Drug Application (NDA) and intellectual property related to Endeavor's Enjuvia synthetic conjugated estrogens product, and two early-stage development female healthcare products. The transaction will cost approximately $35 million. "The pending acquisition of Enjuvia and the two early stage development products will enable Barr to broaden its line of hormone therapy and other female healthcare products," said Bruce L Downey, chairman and CEO, Barr. "We believe that Enjuvia, which is a patented synthetic conjugated estrogens product, will allow Barr to bring a new generation of products to American women electing to use hormone therapy." Enjuvia is claimed to be the only plant-derived, synthetic conjugated estrogen product that includes the component delta 8,9-dehydroestrone sulfate, an additional active estrogenic component. Some studies suggest that delta 8,9 contributes to the relief of vasomotor symptoms. Vasomotor symptoms experienced by menopausal women include hot flashes, chills, burning or tingling sensations and sleep and mood disturbances. Guava raises $27 million Guava Technologies, Inc., a biomedical products company focused on developing and commercializing cell-based analysis systems for life science R&D and clinical diagnostics, has successfully completed $27 million in a Series D private venture financing. The financing was led by Boston-based venture capital firm, HLM Venture Partners and included Series C investors. Guava expects to use the financing proceeds to expand its marketing and sales capabilities and to develop new products focusing on cancer research, drug discovery, cell profiling, bioprocessing, clinical immunology and other fields of use. "Guava is revolutionizing the way cell biologists conduct their experiments by providing them with easy-to-use microvolume cytometers at their benchtops. In combination with the company's proprietary assays and software applications, Guava's systems provide turnkey solutions, enabling researchers to perform more experiments faster than ever before," said Ed Cahill, managing partner, HLM. Ingenium raises $13.8 M Ingenium Pharmaceuticals AG announced that it has raised $13.8 million in its third round of private financing. The round was led by new investor HBM BioVentures (Cayman) Ltd and prior Ingenium investors TVM Techno Venture Management and Polaris Venture Partners. "This round of investment ensures Ingenium's further success in building a world leading drug-discovery company," said Michael C Nehls, CEO Ingenium. "Ingenium has proven its ability to establish and manage effectively a hybrid business model that will deliver long-term value through our internal drug discovery research and our Deductive Genomics agreement with Elan as well as near and mid-term value through multiple partnerships based on our INGENOtyping technology platform," added Nehls. GlycoFi secures $10 million GlycoFi Inc closed a $10M series C financing round led by Fletcher Spaght Ventures with significant participation from Borealis Ventures, Boston Millennia Partners, Polaris Ventures, Schroder Ventures Life Sciences, and Village Ventures among others. As part of the financing, Robert Mashal, MD, partner at Boston Millennia Partners will join GlycoFi's board of directors. Charles Hutchinson, CEO, GlycoFi said, "This financing will accelerate GlycoFi's second-generation biologics development programs, while simultaneously increasing the scale of the company's collaborative activities." "Within the pharmaceutical industry, protein-based therapies constitute the fastest growing segment," said Fletcher Spaght Ventures Partner John Fletcher. "Within that space, GlycoFi really stands out with a diversified business model that has both a near term licensing component and a long-term opportunity to develop its own therapeutic candidates. With the ability to accurately control glycosylation, GlycoFi's technology offers a unique and robust platform to produce homogeneous and improved therapeutic proteins." GlycoFi is the industry leader for the engineering and production of therapeutic glycoproteins in yeast systems. The company was founded in 2000. Volcano completes $50 million financing Volcano Therapeutics Inc., a leading manufacturer of invasive cardiac diagnostic medical devices, announced the completion of a comprehensive financing package with proceeds totaling over $50 million. Volcano Therapeutics is focused on the discovery, development and commercialization of products for the diagnosis and treatment of atherosclerosis and vulnerable plaques in the coronary or peripheral arteries. Vulnerable plaques are the leading cause of heart attacks that kill over 1 million people worldwide each year. Participating in the financing were existing investors Domain Associates, Johnson & Johnson Development Corporation, Medtronic, Neomed, and Mayo Medical Ventures. New investor Ferrer, Freeman & Company ("FFC") contributed significant capital to the financing and will appoint a member to Volcano's board of directors. FFC is a private equity firm based in Greenwich, CT that invests exclusively in health care and health care-related companies and has over $500 million under management. Silicon Valley Bank and Western Technology Investment have also provided secured debt facilities to the company. "We are very pleased with the results of these financings and the high caliber of our financial investors. This is a positive endorsement for Volcano's technology platforms and demonstrates a high level of investor confidence in our current market potential. Proceeds from the financings will be used to support Volcano's strategy to develop and market groundbreaking new technologies for the diagnosis and treatment of atherosclerosis, with the first being the planned commercialization of Virtual Histology IVUS technology in mid-2004. Volcano plans to add Virtual Histology IVUS technology to its installed base of more than 1,200 IVUS consoles currently in clinical use worldwide," said Scott Huennekens, president and CEO. Immunicon raises $25 million Immunicon Corp., a private biomedical products company focused on the development and commercialization of cell-based diagnostic, life science research, and pharmaceutical development products, has raised $24.75 million through a private offering of convertible preferred equity. "These funds will support initial commercialization and marketing of our cellular analysis platforms in cancer," said Edward L Erickson, chairman, president and CEO, Immunicon. "Including the proceeds of this financing, Immunicon has now raised well in excess of $100 million in capital. Of that amount, about $86 million is equity," said James G Murphy, senior vice-president, finance and administration, and CFO Immunicon. Participants in the offering were TL Ventures, Claneil Enterprises, Johnson & Johnson Development, Canaan Partners, Anthem Capital, Burrill & Company, Foundation Medical Partners, Wheatley Partners, MDS Capital of Canada, The Cleveland Clinic Foundation, equity4Life, and MedCapital Investments. The company developed a federation of platform technologies based on selection and analysis of rare cells in blood and potentially other bodily fluids. Its principal focus is cell-based and molecular diagnostic products for the diagnosis, staging and monitoring of cancer. The technology is broadly applicable to other fields in diagnostics, life science research and drug development. The company has submitted three regulatory applications to date with the US FDA. United Biosource secures $153 million United BioSource Corp., which provides science and evidence-based services and information to the pharmaceutical and life sciences industries, has secured $153 million in private equity funding for acquisitions and development. Ethan D Leder and Mark P Clein, founders of the Washington DC-based company, said they will use the equity funding to acquire premier companies with proven track records of providing value-added services in the pharmaceutical and life science sectors. United BioSource also anticipates making significant investments in the acquired entities to support product and service developmenct and expansion of sales and marketing. "The biopharmaceutical industry is undergoing dynamic and disruptive change. New technologies, regulatory pressures and economic realities are driving biopharmaceutical companies to identify 'best practices,' consolidate vendors, and demonstrate more value," said Leder, chief executive officer. "We are targeting companies with revenues of at least $10 million, but with no upward limit," Leder said. The $153 million in equity capital commitments was raised through several investors, including Whitney & Co., Oak Investment Partners and Grotech Capital Group of Baltimore. ]]> <![CDATA[Glow in the dark fish]]> https://biospectrumindia.com/news/95/4165/glow-in-the-dark-fish.html https://biospectrumindia.com/news/95/4165/glow-in-the-dark-fish.html Thu, 08 Jan 2004 17:54:00 +0530 We can soon have a bit of biotechnology gracing our living roomsâ€”genetically modified fluorescent aquarium fishes. "GloFish", as these GM fishes are called, are fluorescent zebra fishes, which contain a gene from a sea coral that makes the fish bright red under normal light and fluorescent under ultraxviolet light. Normally zebra fishes are silver and black in color. In other features, GloFish are the same as other zebra fishes from general care and temperature preferences to growth rate and life expectancy. These fishes were developed at the National University of Singapore for use in environmental monitoring. The scientists wanted to develop indicator fishes that would glow on encountering certain pollutants. The first step in developing the contaminant detecting fishes was to create fishes that would fluoresce all the time. These were licensed by Yorktown Technologies, a Texan company. Fluorescent zebra fish has been a reliable model for scientists worldwide to better understand important questions in genetics, molecular biology, and vertebrate development. These have been particularly helpful in understanding cellular disease and development, as well as cancer and gene therapy. And till date most animals have been genetically modified for scientific or medical research but manipulating them for ornamental purpose has raised ethical questions and fears of setting an unhealthy precedent. Environmentalists are also worried about the fish entering the natural waters and disturbing the natural ecosystem. Although the pros and cons of commercializing the GloFish are still being debated, Yorktown Technologies plans to start selling them from January next year. First artificial protein created Scientists are one step closer in understanding the intricacies of protein dynamics. Researchers at the Howard Hughes Medical Institute have successfully designed and built the first artificial protein called Top7. This novel 93 aminoacid functional protein was created using sophisticated computer algorithms running on standard desktop computers. On analyzing the three-dimensional shape of the protein it was found to be very close to what the scientists had conceptualized. Protein synthesis per se is a complicated process. Proteins are initially synthesized as long chains of amino acids, which cannot function properly until they fold into intricate globular structures. Understanding and predicting the rules that govern this complex folding processâ€”involving the folding of the main backbone and the packing of the molecular side chains of the amino acids is considered as one of the central problems of biology. The researchers said that the integration of protein design algorithms (to identify low energy amino acid sequences for a fixed protein structure) with protein structure-prediction algorithms (which identify low energy protein structures for a fixed amino acid sequence) was a key ingredient in their success. This achievement will give a further impetus to research on engineering artificial protein enzymes for use as medicines or industrial catalysts. It will also help the scientific community in answering how proteins evolved and why are certain protein folds preferred over others in nature. The details of the study have been published in the November issue of the journal Science. And now a synthetic virus Synthetic life on earth has arrived! A synthetic virus has been created and that too in a record time of 14 days. It took Craig Venter, the scientist who pioneered the mapping of the human genome, and his team just this much of time right from arranging the DNA to build a complete virus capable of invasion and replication. But unlike the polio virus created last year, which set the alarm bells ringing across the scientific community, the synthetic virus created by Dr Venter's team, known as phi X174, infects only bacteria. The scientists zeroed on synthesizing phi X174 because its genome is small (5,386 nucleotides) and total integrity of its structure is required for the virus to replicate. The virus was made by joining together ready-made overlapping DNA fragments called oligonucleotides, each built from 40 chemical building blocks, or bases as per its published genetic sequence. To ensure correct and orderly sequence of bases the team filtered out common oligonucleotides that harbor genetic mutations and used enzymes to paste the oligonucleotides together accurately. When the completed viral genome was inserted into bacteria, it was able to replicate like a natural virus. Genetically, some of the resulting virus strains were found to be 100 percent identical to the natural virus. But this was just the trial round, the scientists ultimately aim to create novel life forms (microbes) which can clean the earth or provide alternate fuel sources like hydrogen or methane gas. That designer bacterium will be 100 to 1,000 times larger than phi X174's genome, containing the minimal number of genes to support independent life. Once created, this minimal microbe could be assigned special functions like degrading pollutants or producing fuel by modifying it with some extra genes. This landmark achievement has brought the scientists one step closer to their final goal but has renewed the debate of misuse of scientific knowledge for creating bioterror weapons and the impact of these synthetic organisms on the environment. The virus was created at the Institute for Biological Energy Alternatives in Rockville, Maryland and this work will be published in an upcoming issue of the Proceedings of the National Academy of Sciences. Novel gene therapy for cancer Researchers at the University of Texas MD Anderson Cancer Center have developed a new treatment system for cancer. It consists of genetically engineering stem cells and injecting them in the body, where the modified cells can find tumors and then produce biological killing agents right at the cancer site. It offers probably the first gene therapy "delivery system" capable of targeting and then attacking cancer that has spread in a patient's body. The researchers have performed a number of successful experiments in mice in support of their claim. Notably the stem cells will not be rejected, even if they are not derived from the patient. The researchers have tested the system in mice with a variety of human cancers, including solid ones such as ovarian, brain and breast cancer, melanoma and even blood-based cancer as leukemia. The drug delivery system is attracted to cancer cells no matter what form they are in or where they are. The therapy uses human mesenchymal progenitor cells (MSC), the body's natural tissue regenerators. These unspecialized cells can migrate to an injury by responding to signals from the area. There they develop the kind of connective tissue that is needed to repair the wound and can become any kind of tissue required. Tumors are "never-healing wounds" which use mesenchymal stem cells to help build up the normal tissue that is needed to support the cancer, thus there is constant remodeling of tissue in tumors. Researchers have taken advantage of this ability of the tumor to attract the stem cells. In their novel delivery system, researchers isolate a small quantity of MSC from bone marrow, and greatly expand the quantity of those cells in the lab. They then use a virus to deliver a particular gene into the stem cells. When turned on, this gene will produce an anti-cancer effect. When given back to the patient through an intravenous injection, the millions of engineered mesenchymal progenitor cells will engraft where the tumor environment is signaling them, and will activate the therapeutic gene. During the experiments the researchers found that when mice having metastatic tumors in the lungs were treated with just four weekly injections, their lifespan doubled, on average. They also discovered that when treated cells were placed under the skin of the mice, there was no effect. The cells are required in the immediate environment of the tumor to work, which suggests that normal tissue will not be adversely affected. Though it may be required to further fine-tune the genes that are delivered, but the very fact that these cells are capable of migrating from the bone marrow or blood circulation into tumors suggests its potential. M D Anderson has filed patent applications on the system. ]]> <![CDATA[OptiCell, a complete cell management system]]> https://biospectrumindia.com/news/95/2106/opticell-a-complete-cell-management-system.html https://biospectrumindia.com/news/95/2106/opticell-a-complete-cell-management-system.html Thu, 08 Jan 2004 16:02:00 +0530 USA Scientific has launched a unique product on complete cell management, the OptiCell. The unique size, shape and growth surfaces of OptiCell allows to culture, observe, monitor, analyze, and transport cells more easily and efficiently than ever before. One OptiCell frame has the same footprint as a 96-well plate and is about 6 mm thick. 20 OptiCell chambers provide the growth surface of nearly 26 T-75 flasks in less than half the space. A typical 5 cubic foot incubator can hold upto 900 OptiCell chambers. Each OptiCell has two 50 cm² gas permeable, optically clear growth membranes. About 10 ml of media covers both membranes. The membranes exchange O2 and CO2, maintaining a stable pH and optimal oxygenation of the cells. OptiCell enhances all cell culture activities from growth and magnetic separation to transfection, cloning, and drug discovery. It facilitates the production of monoclonal antibodies, cytokines, and other secreted molecules, and accommodates continuous media perfusion and recovery. For further information, visit: www.biotechindia.com On-line total organic carbon analyzer from Anatel Anatel's Access 643 Total Organic Carbon(TOC) analysis system is designed specifically for the pharmaceutical industry to meet all the requirements for the USP and TOC conductivity methods. It maximizes the convenience of on-line analysis by using a multi-point calibration procedure at pharmaceutical TOC levels that can be performed conveniently and directly at the installation site. The Access 643 includes a user-friendly menu driven system suitability test that automatically calculates the required response efficiency and indicates the water's pass/fail status. USP method is also easily performed with the Access 643 with the inclusion of a receptacle for inserting a NIST traceable resistor for the meter accuracy test. A fully integrated validation package is available for the Access 643 TOC analyzer. This comprehensive hardware and software validation package is a simple, easy to follow step by step plan for system validation. It identifies the required activities to ensure proper installation, operation and performance of the Access 643 TOC analysis system, as well as compliance with industry standards. For further information contact: sheesh@vsnl.com ND-1000 Spectrophotometer launched by NanoDrop Technologies NanoDrop Technologies Inc. has come out with a new spectrophotometer, which makes UV/Vis analysis faster and easier while giving highly accurate results. It eliminates cuvettes and capillaries as the sample is pipetted directly on the measurement surface. The sample size is as small as one microliter. ND-1000 draws the sample between the ends of two optical fibers to establish the measurement path and automatically takes the full-spectrum measurement. It is ideally suited to many small volume applications like measuring protein concentration, cell density, nucleic acid samples, etc. For further information, contact: info@nanodrop.com       ]]> <![CDATA[New executives at Nicholas]]> https://biospectrumindia.com/news/95/2388/new-executives-at-nicholas.html https://biospectrumindia.com/news/95/2388/new-executives-at-nicholas.html Thu, 08 Jan 2004 15:56:00 +0530 p ALIGN="left">There have been major changes at the top level in Nicholas Piramal India Ltd (NPIL). Four senior officials have relinquished their posts. V Hariharan, senior vice-president finance, Sainath Iyer, president (Actis division), SM Raina, vice-president (exports), and Srikumar Chattopadhyay, vice- president (knowledge resources) have quit NPIL Raina and Chattopadhyay have joined Alkem Laboratories as senior vice-president (international operations) and vice-president (knowledge resources), respectively. Iyer is learnt to have joined Pune-based Emcure Pharmaceuticals and Hariharan has joined as chief financial officer (CFO) in Strides Arcolabs Ltd. The company has already filled the posts that have fallen vacant. Rajesh Ladda has joined NPIL as the company's new senior vice-president (finance), Sailesh Gadre is president (Actis division), Ananth Narayan will be the new vice-president (exports), and Sohail Abidi is the company's new vice-president (knowledge resources). Dr M Anand Dr M Anand joins Pfizer Dr Mohanish Anand has joined Pfizer Ltd as head, clinical alliances and support. Before joining Pfizer he was with SIRO Clinpharm Pvt Ltd as manager, business development. Having done his PhD in Applied Biology from Tata Memorial Center, University of Mumbai and PG Diploma in Management at NMIMS, Mumbai, he started his career at SIRO Clinpharm. He worked in different roles from manager projects to manager business development in his stint of over three years. At SIRO, he was involved in structuring its strategic alliance with Covance Inc. USA. Lupin inducts Marc, Sunil Pharma major Lupin Ltd has inducted two representatives of Citigroup, Marc Desaedeleer, who heads Citigroup's private equity business across Central and Eastern Europe, India, the Middle East and Africa, and Sunil Nair, managing partner of CVC International on its board. Recently CVC International, a Citigroup Global Investments Unit acquired 12.55 percent state in Lupin Ltd. Sunil Nair said that Lupin is our first company to venture in pharma sector in India. Looking at the opportunities in biotech field in India CVC International will definitely look at biotech too in near future. Marc said that CVC was looking at its investment in Lupin as a long term one. N Vaghul N Vaghul joins APIDC-VC Narayanan Vaghul has joined APIDC Venture Capital Ltd as chairman, investment committee for the biotech fund. Vaghul is currently chairman of the Board of ICICI Bank, which is the second largest bank in India. Vaghul said, "Biotechnology is an area where India has significant advantages, and the major growth needs to come from start-up and early stage enterprises similar to the experience in the West. The most critical ingredient for the success of these enterprises is early-stage venture capital. However, less than a handful of VCs are addressing early stage venture capital requirements in India today. APIDC VCL fills this gap perfectly." Vaghul is considered to be the father of the Indian venture capital industry in India. Vaghul had joined ICICI in 1985 as chairman and CEO and relinquished his position as CEO in 1996. During his 11-year tenure, he had transformed ICICI to a well-diversified financial conglomerate. He was instrumental in starting an investment bank, a commercial bank, an asset management company, India's first credit rating company Crisil, as part of the ICICI group. Importantly, Vaghul was responsible for the launch of India's first venture capital Company TDICI, now called ICICI Ventures. He initiated venture capital activity in ICICI in the late eighties and then created its wholly-owned subsidiary, TDICI, to provide technology venture capital. In addition to being the chairman of ICICI Bank, Vaghul is also the chairman of India's first asset reconstruction company (ARC) and the chairman of ICICI Knowledge Park. Prof. Hoffman felicitated Prof. Allan S. Hoffman, Department of Bioengineering, University of Washington, USA received the Chandra P Sharma Award for the year 2002 at the XIV National Conference on Biomaterials and Artificial Organsâ€”BIMAO 2003 held at IIT, Mumbai. Prof. Hoffman has over 300 publications, several books and chapters, 21 patents and other patents are pending too. His activities include synthesis, characterization and application of site specific conjugates of smart polymers and genetically engineered proteins, synthesis and characterization of natural polymer hydrogels for use as tissue engineering matrices or as coatings for implants, design and synthesis of acid sensitive polymers for incorporation into drug delivery formulations where acidic environments are encountered during drug delivery and surface modification and characterization of polymeric biomaterials. His work brought him many laurels such as Clemson Award in biomaterials, Founders' Award of the Society for Biomaterials, Japanese Biomaterials Society Science Award, two Controlled Release Society Award etc. ]]> <![CDATA[New look Nicholas]]> https://biospectrumindia.com/news/95/1820/new-look-nicholas.html https://biospectrumindia.com/news/95/1820/new-look-nicholas.html Thu, 08 Jan 2004 15:44:00 +0530 With F Hoffman-La Roche deciding to end its 10-year frame cooperation agreement with Nicholas Piramal, how will it revive it biotech business? F Hoffman-La Roche (FHLR), world's leading research-based healthcare company based in Switzerland, decided to end the frame cooperation agreement with Nicholas Piramal India Ltd (NPIL), a BioSpectrum Top 20 company, with effect from 3 November 2003 for six products. It has appointed Taksal Pharma Pvt Ltd, a New Delhi-based company as new importer and distributor of its products in India. As per the new equation, NPIL's distribution rights for Roche's strong biotech range of productsâ€”CellCept, Zenapax, Cymevene, Mabthera, Xeloda, and Herceptinâ€”have ceased in November 2003. The same for Neupogen and Roferon will end in April 2004. This will follow suit with other Roche products like Vesanoid, Fortovase, Hivid, and Recormon in future. This would mean that NPIL would not have access to any new Roche products for distribution. But if any locally formulated product is to be launched by Roche after November 2003, it will be offered to NPIL subject to Roche's requirements of technical standards being met and if NPIL has no product which competes with the Roche's product offering. However pre-1993 Roche products licensed to or distributed through NPIL may continue to remain with NPIL for a long time. Now, Taksal Pharma will market all the above mentioned Roche products in India through. It may be mentioned that in November 1993, FHLR entered an agreement with NPIL, after which some of the products of Roche were to be distributed in India by NPIL for a specified period of time and certain other brands were licensed to NPIL for manufacturing. In 1997 consequent to Roche acquiring Bohereinger Manheim its products were also being distributed by NPIL. What is intriguing is why FHLR refused to continue its distribution rights with NPIL? Dr GL Telang, managing director, Roche Scientific Company (India) Pvt Ltd informed, "With the growing economic scenario, FHLR has decided to cease the agreement with NPIL. We are looking at focused distributors. NPIL is into diversified areas as against Taksal, which will handle only our products and provide cost-effective new therapies. " Further intriguing is the fact as to what will NPIL do in the changed scenario. In 2002-03, out of the total revenues of Rs 1,140 crore, NPIL's biotech business was Rs 70.64 crore. Off Rs 70.64 crore, NPIL's business importing and distributing Roche biotech products was close to Rs 50 crore. So the ending of the agreement with FHLR, say industry observers, would result in decrease of NPIL's biotech revenues. Responding to that Dr Swati Piramal, director, strategic communications, Nicholas Piramal India Ltd, quipped, "Yes you are right. We do lose the revenue. But we are planning to fill the gap introducing other biotech products. We are launching biotech products from an Italian company in December-January timeframe. We are also in discussions with other companies to partner with us to launch newer biotech drugs in India." About the agreement with Roche, Dr Piramal said, "We know that it will end. The idea was to bring it to certain level and then hand it over to Roche on a platter when it starts its full operation. Now 2005 is near and Roche wants to come on its own. We have maintained very good relations. When we transferred all the things to Roche on 3 November not a single patient was affected. It was a beautiful transaction." She continued, "We not only started the agreement but also ended it properly. We stick to the agreement in letter and spirit. That is why most of the companies will look at Nicholas Piramal for tie-ups and joint ventures. The agreement with Roche has ended on 3 November for six products. We have a long-term agreement with Roche. For some products like diagnostic kits, we had an agreement in 1998, which will end in 2008. For some other products the agreement will end in 2018. So this makes no difference for us," said Dr Piramal. Dr Swati Piramal definitely has the pulse for the Indian biotech market. She started marketing of biotech products in India as early as 1983 at a time when biotech products were available at Rs 10,000 per unit as against the usual drug of Rs 3 per unit. Substantiated Dr Piramal, "It is a wrong notion that we have distributed the biotech products. Instead, we have marketed the products skillfully. We trained our medical representatives to market biotech products. That doesn't go away." True. To make up for the deficit, NPIL is getting aggressive. It has increased its research activity in biotechnology. It is focused on four key areas namely, new drug discovery, genomics, clinical and naturals research. It has nominated two scientists of international repute, Prof. Bob Chaudhari and Dr Ravinder Maini as its scientific advisors. NPIL has also made an initial investment of Rs 10 crore and is planning to pour in another Rs 65 crore in its R&D activities. Besides it is also looking at strategic R&D alliances in four specific areas namely vaccines, functional genomics, cancer research and arthritis. Nicholas entered into strategic alliance with Biogen Idec, one of the largest biotech companies globally. NPIL's Bioteck division will market Avonex (Interferon beta 1a) a leading life-saving therapy for multiple sclerosis in India and Nepal. Biogen Idec is a $2.3 billion revenue. To start with NPIL will tap 50 patients with multiple sclerosis out of 50,000 patients identified so far in India. During the initial months it is expected to earn about Rs 2.5 crore from Avonex, a Pre Filled Syringe (PFS), which is a proven treatment for effective management of relapsing multiple sclerosis. VP Kamath, senior vice president, NPIL informed BioSpectrum that, "NPIL would launch Avonex by first week of January in India instead of mid December. This is mainly because of technical problems." It also launched Curosurf, a lung surfactant for premature babies with Respiratory Distress Syndrome (RDS). It is a product of Chiese Farmaceutici, a European pharmaceutical company headquartered in Parma, Italy. The strategic tie up with Biogen Idec and Chiese Farmaceutici will bring in some biotech revenues to NPIL's coffers. To move things rapidly, it has a joint venture with New Delhi-based Institute of Genomics and Integrative Biology, which is into functional genomics. It has also signed an agreement with the Center of Biotechnology (CBT) at Anna University in Chennai for exclusive R&D collaboration in the areas of cancer and inflammation. The agreement is designed to fast track the identification and development of plant extracts in the repository of CBT for the treatment of rheumatoid arthritis and cancer. As NPIL is still into research it may take time to come out with its own biotech products. Nonetheless, it is moving in the right direction. Narayan Kulkarni Biofuel, a national agendaBiofuel Biofuel, a national agenda Six-point agenda to incubate biodiesel industry in India. There is no denying that India's import bill of crude oil and petroleum products can be cut down by five percent. Further companies are seriously looking to set shop in this area. Most of them say that a proper policy framework will help speed up the biofuel industry. 1. Legislation to enforce and encourage biodiesel usage in India in a phased timeline and on locally available basis. EU nations enabled the legislation as the first step in biodiesel initiative with a 20-year horizon. The US is also enacting a similar legislation next year and some states like Minnesota have already enacted legislation as the first step with time horizon for 10 years starting 2005 with an initial blend of 2.5 percent on a locally available basis. Australia is enacting the legislation soon with a time horizon of 20 years starting 2005 with an initial blend of 5 percent. Legislation with a time horizon will enable the industry to strategize and initiate the incubation process, as the time lag to incubate biodiesel industry will be a minimum of two-three years. 2. Classification of biodiesel industry as per central revenue act. To classify biodiesel industry as in the west (EU and USA) in the category of "RENEWABLE ENERGY", "NON-ODS", "GHG REDUCTION" "POLLUTION SUBSTITUTION" refinery.) Biodiesel industry is technically classified to be in all these categories. Classification will help the industry to enable the clearance of various formalities with state and central government agencies. This should be the second step in the list of priorities for the legislation. Clarity of classification will help financial institutions and lenders to also view this industry in the right perspective. 3. Sales tax and excise duty exemptions. In view of the uncertainty in feedstock and market pricing and also the initial high cost of technology and feedstock, sales tax and excise exemptions are a must during the initial years (3-5 years) for the biodiesel industry to stabilize. EU, USA and Australia have already enacted legislation to facilitate the same. 4. Customs duty exemption under project imports for biodiesel technology. Biodiesel technology is highly mature and is being operated in large industrial scale globally. Biodiesel technology is available for transfer into India and as there is no proven technology model in India, Indian industry should be allowed to import technology into India with out any customs duty. 5. Customs duty exemption on import of non-edible grade feed stocks. To commission industrial scale biodiesel plants, non-edible grade feed stock is not yet available in India as the Jatropha plantations initiative by the government may take some time to incubate and for the said feed stock to become available in sizable scale to commission biodiesel plants. As there is a plenty of non-edible grade vegetable oils available in overseas markets at very reasonable prices, biodiesel industry should be allowed to import these non-edible feed stocks on "selective and temporary basis" until the Indian feed stock is made available. "This will help the biodiesel industry to commission industrial scale plants to be ready to absorb Jatropha oil as and when it is available from domestic sources" and will also help domestic biodiesel industry to give buy back agreements for Jatropha oil to local farming community. 6. Constitute a central biodiesel board of India to monitor and facilitate quality, growth, feed stock and technology. Such a centrally constituted board with the participation of all channel partners of biodiesel industry will facilitate elimination of any unforeseen bottlenecks and unhealthy practices to promote this industry in India. Biotech, a chirag for SMEs The Indian scenario is ripe with possibilities for new biotech entrepreneur. With an expected industry growth of over 20 percent in biotechnology, investors are looking at biotechnology as a new area of investment, particularly the Small and Medium Entrepreneurs (SMEs). But the thing is they don't know where to invest. What are the opportunities? How to get the funds? "We are looking at expanding our business in the areas of biotechnology. So we are eager to know the latest technologies coming up in bio fertilizer, tissue culture and other areas of biotechnology, and the government support for making investment, " said Edward Menezes, director, Rossari Biotech India Pvt Ltd. Similarly Deva Drill Tech (I) Ltd, which is into specialty chemicals, is looking at diversifying its area of operations. AV Mohan Kumar, chairman and managing director, Deva Drill Tech said, "I feel people in the next 10 years will look at bioproducts rather than synthetics ones. The opportunities for bio products are enormous. Hence we are looking at tissue culture, industrial enzymes, and stem cell research as areas of our expansion. " India is ripe with possibilities for new biotechnology entrepreneur. Researchers are ready to forge links with other researchers and universities and especially with industry so as to meet its main goals of fundamental research together with technology that would make lasting impact on the health care scenario locally and globally. But the entrepreneurs should be focused said Prof. Jayesh Bellare, head, school of biosciences and bioengineering, IIT Powai. He suggested a seven-point agenda for the potential biotech entrepreneur. "Level of education, interest to take up challenges and willing to do wet lab work, patience, updating of knowledge, awareness about the regulatory affairs and willing to comply with them, a broad spectrum of life science activity and deep pockets." Availability of technologies Researchers and scientists at different institutes like IIT, Baba Atomic Research Center, Central Institute of Medicinal and Aromatic Plants (CIMAP), Central Institute of Brackish water Aquaculture (CIBA), The Energy and Resource Institute (TERI), CSIR labs, TIFR, IISc and many other centers-of-excellence are developing many technologies. Some technologies such as shrimp feed technology (CIBA), arbuscular mycorrhiza fungi (TERI), cultivation and processing of spirulina (ICAR), development of non-conventional products from banana, pheromone, biodegradable waste management, seromone (BARC), process for producing alcohol, and process of multiplication of bamboo plantlets (National Chemical Laboratory) are already available for transfer. Since the above institutes are not looking at profits the technology transfer will become easy for the companies. Following the technology transfer is the financing. To take an early lead in this sunrise sector, many venture capitalists, ministry of Small Scale Industries, nationalized banks, financial institutions are coming forward to lend financial support to SMEs. Dr CP Thakur, union minister for Small Scale Industries, who believes that SMEs are the key for the economic growth of country said, "The ministry is discussing with the finance ministry about the availability of easy credit to biotech entrepreneurs at minimum interest. Grants for upgrading and improving the technology and implementation of credit guarantee scheme are also under consideration." So there is no dearth. The speed program of ICICI ventures, Nmitli program of CSIR, NABARD, Cross Boarder Group, Rabo India and biotech funds by the state governments will provide the financial support for setting up the ventures in biotechnology. However the SMEs have to start the enterprise on their own with seed funding. Once the SMEs come out with products through novel ideas then the venture capitalists will come forward with back up support. The VCs follow certain funding format. This is the best way for the SMEs to build values feel some of the VCs. Awareness Vijay Kumar, deputy director, Small Industries Service Institute, Mumbai, which organized a two-day national convention on avenues in biotechnology for SMEs said, "Organizing conventions is only the beginning. The process will start with such programs. The symposiums will provide only the tips. Regular interaction will help setting up new enterprises." "Anticipation and looking ahead is the key to success. And one has to think about innovative ideas. India needs more intellectuals in the field of biotechnology. In the pre-budget submission, the ministry of SSI has asked more packages for SMEs who are looking at biotechnology as a new way to economic growth," informed Dr CP Thakur, union minister for Small Scale Industries. Expressing discontent about not participating in the human genome research, he said, it would have opened up more research opportunities if India participated in it. "Biotech is the future of India. It is an integrated field. We have to work in close association with other fields. Lack of teamwork and execution is pulling the efforts made by an entrepreneur. The local firms have to stick to global standards in manufacturing process and supplying quality products," said CL Rathi, managing director, Advanced Biochemicals. Considering the present trend in biotechnology Dr SPS Khanuja, director, Central Institute of Medicinal and Aromatic Plants, Lucknow, observed that in near future both agri and pharma biotechnology will merge with the growth of neutraceutical sector. This will provide wider scope for the entrepreneurs. The unfurling opportunities, support from the government and industrial bodies in bringing in awareness about the latest technologies, readily available technologies, etc. have opened the doors for SMEs. "But an entrepreneur has to take initial risk to reap the profits," sums up Prof. Bellare. Narayan Kulkarni     ]]> <![CDATA[Bringing international tools and techniques to India]]> https://biospectrumindia.com/news/95/2623/bringing-international-tools-and-techniques-to-india.html https://biospectrumindia.com/news/95/2623/bringing-international-tools-and-techniques-to-india.html Thu, 08 Jan 2004 14:57:00 +0530 Bringing international tools and techniques to India GENETIX Established in 1991, Genetix Biotech Asia is one of the first few companies to warehouse life sciences products from its major suppliers. Its business of stock and sell has been a real success story as the company has grown by 100 percent every year for the last two years. The revenue figure of Genetix in 2003-2004 is projected to be Rs 25 crore. Genetix is among the few companies, which is supplying world's latest technologies and tools to the Indian biotech industry.It represents some of the world leaders in biotechnology/life science products like filtration systems and devices, molecular biology kits and reagents, biochemistry, protein chemistry and immunology reagents, chemicals used in cell and tissue culture, serum, media and chromatography accessories. It started its work for the Indian biotech industry almost ten years ago as an indenting company for marketing and providing technical support to Indian customers for all the products in its portfolio. Now, with the advent of new initiatives in the Indian biotech industry, Arun Prakash, MD Genetix, is confident that the company's graph will rise. Speaking about this niche market segment, Arun said, "now the picture of the industry is getting more favorable for the entrepreneurs. New companies are also showing good interest. The Indian biotech industry has shown good growth for the past four or five years and all these signs are showing that the next five to ten years will witness a great boost for the industry. It has also been estimated that the industry is growing by 20 to 25 percent." Companies represented by Genetix Life Sciences Division  Qiagen GmbH  Operon Technologies  Ambion, USA  MBI Fermentas  Biometra GmbH  Amresco, USA  JRH Biosciences, Australia  SantaCruz Biotech  Upstate Biotech, USA  Amaxa Biosystems GmbH  Duchefa Biochemicals BV  Nalgene Nunc International, USA  Nunc A/S, Denmark  ICN Biomedical  AB Biodisk, Sweden  Invivogen, USA  Cayman Chemical  Tosoh Biosciences, GmbH  Mobi Tec GmbH  Thomas Scientific USA Process Separation Division  NalgeNunc International, USA  Nunc A/S, Denmark  TosoHBiosep GmhH  HyClone, USA  Sanitech (Saint Gobain Performance Plastics)  Kimble Kontess  Spectrum Laboratories Commenting on industry dynamics, he added, "in India, most federal government funded customers prefer to order directly with the parent companies, as they are custom duty exempted but only for the R&D work. Way back in 1996, Genetix took advantage of the growing market in private sector and reduction in custom tariffs to import and 'stock and sell' over 2500 products from international brand names like Nalgene, Nunc, Clontech, Qiagen, Hyclone, Pierce, Amresco, SantaCruz and others. Our business partners in the US and Europe have been very supportive so as to offer us very attractive transfer prices to off-load some part of custom tariffs, which varies between 54-72 percent." Informing about the company's experience in the industry, sales manager (HRD and Logistics), AS Anthwal said, "the company's team is its strength. The skilled technical workforce we have is making us successful. Business/technical representatives of Genetix have a sound technical background in life sciences and industrial biotechnology. They have also undertaken technical training programs with our principals in India or abroad. The qualification of technical support team is specialization in molecular biology with PhD/post doctorate in biochemistry. This gives our customers strong confidence on us."Regional manager of Qiagen, Dr Astrid Lefringhausen, who was recently in India, appreciated Genetixâ€”Qiagen's Indian marketing partner. She said, "Qiagen's marketing strategy for Indian operations has the strong support of Genetix's nationwide network and technical competency." The company has sales representatives in all major cities of the country. Genetix has several divisions to facilitate systematic and streamlined working. The Life sciences/clinical division has a well qualified technical team having experience in all molecular biology techniques like PCR, sequencing, cloning, etc. The company has expertise in in-situ hybridization/immunohistochemistry, translation /transcription, cell and tissue culture techniques, immuno diagnostics and protein chemistry. The process and separation division provides application support for up and downstream processes to pharma and vaccine companies It is notable that Genetix has a firm grasp of the functional intricacies of the bureaucracy in India. This is of considerable advantage in expediting the procedural machinery, particularly in view of its major clientele in India, which consists of government or government funded bodies. With its expertise and experience the company is all set to sustain itself and grown along with the industry. "Import duties needs to be cut short" A company's strength lies in its technical competence, sales skills, coverage and warehousing. And the person in charge of these policy decisions is none other than the MD of the company. Coming to Genetix, under the leadership of Arun Prakash, MD, Genetix, the company has achieved new heights. Being in the industry for more than ten years and supplying international quality products is a challenge in itself. Talking to BioSpectrum, Arun Prakash sketched a clear and broad picture of the Indian biotech Industry. You have completed more than ten years in the Indian biotech industry, how was the experience and how is the picture changing? Being in this segment has given us a good experience. We were the first and the only company in India, which started warehousing of life sciences products. When we started, in 1991, the biotech industry was like a child, now it has become a youngster but maturity is yet to come. Technically speaking, in the last five years the industry has shown real growth. The industry is growing at rate of 20 to 25 percent, and this growth rate is quite impressive. And by looking at the present scenario, it can be predicted that this growth rate will continue for more years to come. How is Genetix gearing up to face the changes in the industry? What are the new developments happening in the company? We have recently set up a full-fledged molecular biology and cell culture laboratory for in-house training, customer demonstration/training and quality control back up. In future this facility will be utilized for running PCR courses for private diagnostic laboratories, develop molecular diagnostic products for infectious diseases and take up contract research. Since molecular biology is catching up with the industry, we have taken this initiative. But in terms of tie-ups, there are some surprises in store for the industry from our banner. As the deals have yet to take the final shape, it is not appropriate to disclose them now. Apart from that, we have to strengthen our focus of providing best available quality with an effective service to our customers. What challenges lie ahead of your company in achieving the target? The biggest challenge is the logistics. The high duty charges are also a major hurdle for any customer. Apart from these, the time consumed in delivering the products, storage conditions, exchange, etc. are among our list of hurdles or challenges. The amount of bureaucracy involved in any transaction is also responsible for the slow pace of the industry. India has highest duty charges in the whole Southeast Asian region. The importance of biotech education is being increasingly recognized. How do you foresee this opportunity from the business point of view? It is a positive indication that several educational bodies are taking biotech into their syllabus. This will generate the much-needed workforce for the industry in the future, and even in today's context, it leads to a great opportunity. I am talking about the establishment of laboratories at schools and colleges level. But at the same time, it is very critical from student's point of view to opt for biotech during his or her early stages of career. Though Genetix is supplying the latest western technology and tools into India, how about the awareness level of western trends among the Indian scientific community? India scientists are well aware of the latest tools and techniques used in biotech applications. But the factor differentiating us from west is that our scientific community does not trust those techniques and tools, which are catching up in the west. We consider only those techniques that are well established in west. This factor pushes us back in the race. What will be the future of biotech in India? Which areas are going to be affected by the biotech buzz? The future of pharma industry is going to be influenced by biotech in a big way. The coming years will definitely witness lot of biotech applications in therapeutics and medical diagnosis. The biotech trend is catching up fast in the pharma industry. What policy amendments are required for the success of the Indian suppliers and why? The duty structure needs to be looked upon. In my view, the duties should be cut short. This factor is affecting the customer buying power. This results in discouraging the industry in doing high-level R&D. Cost is the biggest factor for any project or research work. And for smooth running of R&D work, the researchers needs to motivated by cutting short the cost factor. The government should seriously think over it and come out with some positive action. Where does India stands in comparison with other South Asian countries? It is surprising to know that small countries like Singapore and Malaysia are investing a lot in infrastructure for the biotech research work as per the international standards. Although we have right manpower and opportunity, we are still not in a leading position. Do the suppliers need a platform to speak up? Is there a forum already existing for the suppliers? It is unfortunate that there is no forum available for the supplier's community. Whatever forums we have only speak about the big players of the biotech community. These forums will definitely help the supplier community to speak up in front of the government and put across their views. Coming back to Genetix, which are the major successful tie-ups that you have for the Indian market? As a part of our business strategy at Genetix, we only bring the world leaders to India. But major companies like Qaigen, JRH BioSciences, Ambion, NUNC, Nalgene, Fermentes, etc. are among the list of eminent partners. Faiz Askari ]]> <![CDATA[Spliced out]]> https://biospectrumindia.com/news/95/2401/spliced-out.html https://biospectrumindia.com/news/95/2401/spliced-out.html Thu, 08 Jan 2004 14:55:00 +0530 Spliced out   Spliced out After the successful sequencing of the Human Genome, a follow-up and equally, and if not more, important international collaborative project has started to develop the "HapMap". The HapMap will attempt to portray the common patterns of human DNA sequence, which could become a key resource for researchers trying to locate different genes affecting health, disease and responses to drugs and environmental factor. It is certainly another prestigious project. What is surprising from an Indian viewpoint is that our country is not part of this momentous scientific venture. Only researchers from the US, UK, Japan and Nigeria are part of the project. The omission is all the more glaring because Indian researchers were part of the Human Genome project. Who is to blame? Can we wash our sins away, blaming the rest of the world for wrongly keeping India out? Certainly, not. The fault mainly lies with the vast science and technology set-up in the Indian government, which prides itself on the fact that the system has enabled the country to become the third largest reservoir of scientific talent in the world. India has everything going for it to become part of this prestigious project. The human and financial resources will not be a constraint for India. And India is endowed with rich diversity in ethnic profile. Yet, the HapMap will be based on the genetic profiling of a small sample of 270 people from the Yoruba tribe in Ibadan Nigeria; 45 unrelated Japanese individuals in Tokyo, Japan; 45 Han Chinese people from Beijing; and 30 samples collected by the Centre d'Etude du Polymorphisme Humain (CEPH), France. The data will be made available free to the public later. However, India's large pool of genetic researchers could have benefited immensely with exposure of modern techniques as part of the project. But the nation's scientific leadership is strangely silent on this. The episode is similar to that last April when Indian researchers missed the bus during the global race to map the dreaded Severe Acute Respiratory Syndrome (SARS) genome. No one in this country takes the responsibility for gearing up the nation to anticipate such major developments and gain valuable research experience. The plethora of scientific agencies makes it easy to diffuse the ownership of any major research initiative. A senior scientist has justified India's non-participation in the HapMap project with the remark that the nation has the capability to take part in huge international projects but the projects have to be evaluated for relevance to India. What a lame excuse! This is the country, which has been investing its precious resources to develop a Hyper Plane (a pet project of President APJ Abdul Kalam when he was the Scientific Advisor to the Defense Minister). We are also planning to land an Indian spacecraft and if possible an astronaut on the Moon, long after the human fascination for our nearest space neighbor has dwindled. At the same time, our country does not have the resources to buy enough planes for our national airlines, Air India. As a result, three-fourths of three million outbound Indians are dependent on foreign airlines for their globe-trotting business and pleasure jaunts. These examples illustrate the fact that our scientific leadership did not deem it serious to participate in a project which would have benefited millions of Indian with appropriate health care solutions early through HapMap. ]]> <![CDATA[Market capitalization, 1994-2003]]> https://biospectrumindia.com/news/95/1014/market-capitalization-1994-2003.html https://biospectrumindia.com/news/95/1014/market-capitalization-1994-2003.html Thu, 08 Jan 2004 14:53:00 +0530 Market capitalization Market capitalization, 1994-2003 ]]> <![CDATA[Ever heard of Hood Robin?]]> https://biospectrumindia.com/news/95/2598/ever-heard-of-hood-robin.html https://biospectrumindia.com/news/95/2598/ever-heard-of-hood-robin.html Thu, 08 Jan 2004 14:24:00 +0530 Science should be developed to address the concerns of the poor. It should not be masqueradered. For Sumitra Behera, 35, a resident of Badibahal village in Angul district of Orissa, selling her one month old daughter for a paltry sum of Rs 10 (approximately 21 US cents), was perhaps the only way to feed her two other daughters â€”Urbashi, 10, and Banbasi, 2. Her husband had died about eight months ago. The shocking reflection of the harsh ground realities that prevail throughout the countryside, and Orissa is no exception, will however soon be buried under denials and allegations. Sumitra Behera's supreme sacrifice comes at a time when Ingo Potrykus, the scientist who invented a genetically altered rice carrying a miniscule percentage of vitamin A, demanded that opponents of genetically engineered crops should be made to stand trial in an international court. "I would make them responsible, have them in an international court and get them to justify the pain and suffering they are inflicting on so many people." The Switzerland-based Dr Potrykus believes that the "Golden Rice" he has produced will save almost one million children a year from going blind. This prompted the ever eager Rockefeller Foundation, European Union and the Swiss government to provide US $ 2.6 million (approximately Rs 12.5 crore) over seven years to the Indian Council of Agricultural Research (ICAR) with the aim to engineer the pro vitamin A genes into the local varieties of rice. If only the same amount of research funding had gone to feed the hungry, over one million impoverished could have been pulled out of extreme hunger in the next seven years. In other words, Dr Potrykus' research has deprived at least one million hungry of their basic fundamental rightâ€”food. Snatching food literally from the hands of the hungry is perhaps the greatest human crime. How will Ingo Potrykus and his supporters like to be treated for exploiting even the hungry for the sake of amassing more profits for the commercial companies? I leave it to him and his tribe to provide the answer. In all fairness, Dr Potrykus is not the only one. What about the 2,000 scientists, including several Nobel laureates, who signed the AgBioView Foundation's appeal in 2001, urging the US Food and Drug Administration (FDA) not to destroy a mere 3,000 tones of genetically modified rice and instead export it to the hungry millions? Their resolve for hunger vanished when told that they should come and help distribute 45 million tones of surplus food grains, much of it rotting in the open in India. After all, if they had joined hands, India could have succeeded partially in removing hunger. With 320 million hungry, India alone has one-third of the world's hungry. What about the Royal Society that castigates the critics of biotechnology, and admonishes the media for printing anything that goes against the commercial interests of the biotech companies? What about the Nuffield Council on Bioethics that unethically appoints a working group of experts, all known supporters of biotechnology industry, so as to convince the British government of its 'moral duty' to invest in GM crops research for the sake of developing countries? All of them, the so-called distinguished academic institutions and forums, swear in the name of hunger and malnutrition, but only if it adds to the profit of the GM companies. If it does not bring profit for the companies, let the hungry go to hell. Let us hear what Prof. Derek Burke, a former vice chancellor of the East Anglia University (UK) and a former chairman of the Advisory Committee for Novel Foods and Processes, has to say about GM technology: " ...the consequence of the loss of this technology for society is the loss of the ability to create new wealth. It's my grandchildren that I'm concerned about. How will they earn their living in 20 years? The answer may lie partly in your hands." Prof. Burke is one of the authors of the Nuffield Council on Bioethics recently released controversial report on the use of genetically modified crops for the developing countries. The report tries to create an illusion as if the interest of the British scientists is the welfare of the poor and hungry in the developing countries. In reality, they are worried about the future of their own scientists, their own children. And you think these are the Robin Hood's of the 21st century? You think they feel compassionately for the hungry and the dying? Think again. Gone are the days when the legendary Robin Hood would rob the rich and give it to the poor. It is just the opposite now. The rich and elite are sparing no effort to rob the poor, even building profits over the starving millions. Worse still, hungry are being robbed of what ever little they live with, ironically under the emotional and scientific cover of eradicating hunger and starvation. These are the Hood Robinsâ€”always willing to exploit the poor and hungry for the sake of corporate interest. The Hood Robins change jobs back and forth between corporate agribusiness and the Agriculture Department until the two are indistinguishable. Hood Robins masquerade as scientists, bureaucrats, as educated entrepreneur and of course as representatives of GM food companies. They have successfully co-opted the public sector university research system in a way that tax dollars support research, which ultimately enhances the company profits. They help the GM companies spend $119 million for lobbying in 1998 in the US alone. What for? "Educating" the American politicians about the virtues of genetic engineering. Not only the American politician, they even set up an NGO that regularly imparts orientation courses to the judges from the developing countries. Scientific research is rigged, alarming evidence of health dangers is covered up and intense political pressure silences the sane voice of dissidents. You have probably heard of the four scientists who dared to stand for the cause of 'good science', their voice was silenced for the sake of the neoclassic model of 'sound science', another name for corporate controlled science. Arpad Pusztai - Consultant, Norwegian Food Sciences Institute, formerly Principal Scientific Officer, Rowett Institute, Aberdeen, Scotland. Discovery - Cytological and histological damage to rodents fed with transgenic (genetically modified) potatoes. Suppression - Dr Pusztai was fired from his position of 30 years as a scientist at the Rowett Institute in Scotland. His research files were seized, including in a break-in at his home. Major campaign of discreditation. John Losey - Associate Professor, Cornell University. Discovery - Damage and death in Monarch butterfly caterpillars fed with pollen from transgenic corn. Suppression - Promotion of research targeted towards discreditation of his discoveries. Media campaign. Tyrone Hayes - Associate Professor, University of California, Berkeley Discovery - Damage to tissues, organs and ecology of amphibian reproduction due to low levels of Atrazine, the most widely used chemical in the US agriculture. Suppression - Attempts at suppressing, delaying and derailing research. Targeted research to discredit his findings. Discreditation campaign. Ignacio Chapela - Assistant Professor, University of California, Berkeley Discovery - Genetic contamination of maize by transgenic (GMO) DNA in its center of origin in Oaxaca, Mexico. Suppression - Attempts at suppressing, delaying and derailing research. Direct threats. Coordinated, industry-funded international discred-itation campaign. Not granted a research extension. Distortions, omissions, cover-ups and bribes are used to promote an unhealthy and risky technology and that too with the 'pious' intention of eradicating hunger. Hood Robin's exploits surely read like adventure stories. Meanwhile, Sumitra Behera has already spent the 11 cents (not enough to buy a bottle of mineral water) that she got for selling her one month old baby. She is probably planning to sell her second daughter, Banbasi, aged 2. That's the only way she can keep herself alive, fighting her daily battle with acute hunger and deprivation. She is in a way lucky that she continues to survive against all odds. Nearly 24,000 hungry like her die every day the world over waiting for food. Not knowing that Hood Robins have siphoned off the money that was meant to provide them with food. Devinder Sharma (Devinder Sharma is a New Delhi-based food and trade policy analyst. Among his recent works include two books: GATT to WTO: Seeds of Despair and In the Famine Trap.) ]]> <![CDATA[Biotech and the global burden of disease]]> https://biospectrumindia.com/news/95/1731/biotech-and-the-global-burden-of-disease.html https://biospectrumindia.com/news/95/1731/biotech-and-the-global-burden-of-disease.html Thu, 08 Jan 2004 14:20:00 +0530 With rapidly increasing consumer awareness, only those technologies will survive in the future that would bring a definable and desirable benefit to the consumer, or help people or government to achieve significant progress. This would be true of biotechnology as of, say, space or new energy targets. One area where humanity expects a great contribution from biotechnology is in respect of management of diseaseâ€”that is, reducing the global burden of disease. What, then, is this global burden of disease? Following a recent study (Ezzati et al., The Lancet, 2002, Vol. 360, pp.1347-1360), this burden can now be stated in precise terms. The above study used data collected from 192 countries around the world. The factors listed in Table 1 were identified as the main causative factors for the diseases mentioned against each factor, different countries contributing to a different extent to the total global disease burden on account of a particular factor. The question we may ask is, where and how can biotechnology contribute to alleviate global suffering on account of the 26 factors mentioned in Table 1. This contribution could be towards prevention of, better and more expedient diagnosis of, and/or cure for a disease. Let me give examples. To take care of vitamin A deficiency mentioned under item 3 in table 1, we need to be able to provide cheap natural beta-carotene, the precursor of vitamin A, which could be used in mid-day meal program in schools. Shantha Marine is already making inexpensive beta-carotene using a marine algae, seawater and sunlight, in their factory in Tiruchendur, TamilNadu. This is an example of how marine biotechnology can provide inexpensive material to take care of one important global burden of disease. However, this is also an example where it is not only the availability of the material but also a concurrent systems approach on part of the government which would ensure that this material is actually appropriately used, that would be important. Monoclonal antibodies (MABs) have proved invaluable as agents of diagnosis of a large number of diseases or for determining the genetic susceptibility status of an individual in respect of a disease. It is a pity that, as of now, not a single monoclonal antibody of Indian origin is in the market. We not only need to fill in this lacuna but also develop newer MABs for diagnosis of disorders that are common for us. Preventive vaccines for diseases such as AIDS, malaria and tuberculosis represent another major need of the time. The production of these vaccines through innovative modern biotechnological routes grounded in imaginative basic research, alone would make them possible and economically feasible. Those interested in biotechnology and medical health care would be doing a tremendous service if they could collectively prepare a document which would state how biotechnology could reduce the global burden of disease, through development of specific preventive, diagnostic and curative regimens, I believe that BioSpectrum is the right vehicle for starting a debate on the above question: that is, how could we, individually and collectively, have biotechnology discharge the above responsibility. Pushpa M Bhargava is one of India's most brilliant scientists. He founded and directed the Centre for Cellular and Molecular Biology (CCMB), Hyderabad. Factors responsible for the global burden of disease S No. Factor Outcome 1 Underweight Mortality and acute morbidity from diarrhoea, malaria, measles, pneumonia and selected other group 1 diseases; perinatal conditions from maternal underweight; long-term morbidity from under nutrition 2 Iron deficiency Anaemia and its sequelae (including cognitive impairment); maternal and perinatal mortality 3 Vitamin A deficiency Mortality due to diarrhoea, measles, malaria and miscellaneous infection causes of disease (children<5 years); morbidity due to malaria (children<5 years); maternal morbidity and mortality (pregnant women); vitamin A deficiency and its sequelae (all age groups); low birth weight and other perinatal conditions 4 Zinc deficiency Diarrhoea; pneumonia; malaria in children aged<5 years; adult and pregnancy outcomes 5 High blood pressure Ischaemic heart disease (IHD); stroke; hypertensive heart disease and other cardiovascular diseases; renal failure 6 High cholesterol IHD; stroke; other cardiovascular diseases 7 High BMI (Overweight IHD; stroke; hypertensive heart disease; diabetes; osteoarthritis; and obesity)endometrial and colon cancers; post-menopausal breast cancer; gallbladder cancer; kidney cancer; breathlessness; back pain; dermatitis; menstrual disorders and infertility; gallstones 8 Low fruit and vegetable intake IHD; stroke; colorectal cancer; gastric cancer; lung cancer oesophageal cancer 9 Physical inactivity IHD; breast cancer; colon cancer; diabetes; falls and osteoporosis; osteoarthritis; lower back pain; prostate and rectal cancer 10 Unsafe sex HIV/AIDS; sexually transmitted infections; cervical cancer 11 Lack of contraception Maternal mortality and morbidity; increased perinatal and child mortality 12 Tobacco Lung cancer; upper aerodigestive cancer; all other cancers; chronic obstructive pulmonary disease (COPD); other respiratory diseases; all vascular diseases and other medical causes in adults > 30; fire injuries; maternal outcomes and perinatal conditions 13 Alcohol IHD; stroke; hypertensive heart disease; diabetes; liver cancer; mouth and oropharynx cancer; breast cancer; oesophagus cancer; selected other cancers; liver cirrhosis; epilepsy; alcohol disorders; depression; intentional and unintentional injuries; selected other cardiovascular diseases and cancers; social consequences 14 Illicit drugs HIV/AIDS; overdose-of-drug-use disorders; suicide and trauma; other neuropsychological diseases; social consequences; hepatitis B and hepatitis C 15 Unsafe water, sanitation and hygiene Diarrhoea 16 Urban outdoor air pollution Mortality from combined respiratory and selected cardiovascular causes in adults >30; lung cancer; acute respiratory infection mortality in children <5; cardiovascular and respiratory morbidity 17 Indoor smoke from solid fuels Acute lower respiratory infections in children <5; COPD; lung cancer, cataracts; tuberculosis; asthma 18 Lead Cardiovascular diseases; mild mental retardation; anaemia; gastrointestinal effects; nervous and reproductive system effects; social consequences of IQ loss 19 Global climate change Diarrhoea; flood injury; malaria; malnutrition; dengue fever; cardiovascular mortality; effects arising from population movement 20 Risk factors for injuries Unintentional injuries; intentional injuries 21 Carcinogens Leukemia; lung cancer; mesothelioma; cancers of multiple other sites 22 Airborne particulates COPD and asthma; pneumoconiosis; silicosis; asbestosis 23 Ergonomic stressors Lower back pain 24 Noise Hearing loss 25 Unsafe health-care injections Acute infection with HBV, HCV and HIV; cirrhosis and liver cancer; selected other infectious diseases 26 Childhood sexual abuse Depression; panic disorder; alcohol misuse/dependence; drug misuse/ dependence; post-traumatic stress disorder and suicide in adulthood; non mental health outcomes such as sexually transmitted diseases, unwanted pregnancies and injuries Note: Factors 1-4 relate to childhood and maternal under nutrition; 5-9 to other nutrition-related risks and physical activity; 10-11 to sexual and reproductive health; 12-14 to addictive substances; 15-19 to environmental risks; and 20-24 to occupational risks. (Adapted from M. Ezzati et. al., The Lancet, Vol. 360, November 2, 2002, pp. 1347-1360) ]]> <![CDATA[IPO Boom likely in 2004]]> https://biospectrumindia.com/news/95/3092/ipo-boom-likely-in-2004.html https://biospectrumindia.com/news/95/3092/ipo-boom-likely-in-2004.html Thu, 08 Jan 2004 14:13:00 +0530 After a lull for 12-18 months, there has been buoyancy in the biotech marketâ€”globally as well as locally. Strong fundamentals, global uptrend, and the booming Indian stock markets give the right platform for the launch of biotech Initial Public Offerings (IPOs). A report on the Indian and global biotech IPO pipeline. Globally, there has been a sudden surge in biotech filings. For instance, towards September-end five Massachusetts firms, Aderis Pharmaceuticals Inc., First Marblehead Corp., Nitromed Inc., TolerRx Inc. and Vaso Active Pharmaceuticals planned IPOs. The combined worth was $400 million. Watertown biotech Acusphere set the tone with $52.5 million debut. The mood was not restricted to the Bay State alone. The same sentiment was reflected across the US. Genitope Inc. went public offering 3,700,000 shares of its common stock at $9 per share on the Nasdaq to raise close to $33 million. CancerVax Corp., a biopharma company focused on cancer therapies, ended up raising $72 million after pricing six million shares at $12 per share. Myogen Inc. raised about $70 million. Adolor Corp.'s offering was approximately $119 million. This is a partial list of IPOs since September. There are about 20 odd biotech companies waiting to go public now and raise close to $1 billion according to some analysts. There have hardly been any IPOs in Europe, but in mid-2004 Europe too is expected to open out. India follows global footsteps The conditions in India are similar or even better than that globally. In fact the trend in the past six months suggest increasing investor confidence and a great IPO bazaar ahead. According to a Business Standard report, IPOs worth Rs 22,000 crore are expected to come out in the next 12 months. In the first six months of this financial year, Rs 1,868 crore was raised through public issues, both debt and equity. The six equity IPOs in the market this year are now commanding a combined market capitalization of Rs 12,839 crore, creating shareholder wealth of Rs 7,795 crore according to the report. Besides, there has been over subscription to almost all the IPOs that have come after September. And experts believe that there would be oversubscription in most cases in future. Biotech may not lead the IPO revolution. But it definitely has a strong case to gain in 2004. With the Securities and Exchange Board of India (SEBI) mandating a wide range of disclosures in the prospectus for public offers, the current list of IPOs that are coming are of quality and with strong fundamentals. This paves the way for companies in biotech too to exploit the markets as during the year, biotech companies have made significant progress on all countsâ€”the ability to attract investments, talent new products and make money too. According to BioSpectrum-ABLE Survey, the biotech industry in FY 2002-03 was Rs 1830 crore. The industry has invested heavily. The total investment in the industry in 2002-03 was Rs 635 crore. The R&D manpower grew over 74 percent. The biotech industry is expected to grow by about 26 percent this year and hopes to invest close to Rs 1,000 crore in the next couple of years. Several biotech companies plan to go public. Biocon, Shantha Biotechnics, Amreshwara Agri Bio, Bharat Biotech, etc. are looking to go IPO. In fact Bangalore-based bio-pharma major Biocon India could be the one to take lead. It is planning a March 2004 launch of its IPO. It intends an equity capital expansion through a restructuring of its paid-up capital and reserves before that. It has also entered a tie-up with the HSBC-ABN Amro Bank consortium for a Rs 150-crore debt financing for part-funding of its Rs 500-crore expansion programme. The public offer will be done entirely through the book-building route and it has appointed DSP Merrill Lynch and Kotak Mahindra Capital as the book running lead managers. HSBC Securities & Capital Markets will be the co-book running lead manager. Biocon has indicated that the company proposes to offer 10 percent of its equity in the IPO, but the size of the issue will decide the company's new equity capital after the proposed equity restructuring plans. The success of Biocon's IPO would set the benchmark for future IPOs in the sector. For it is the No.1 biotech company in the country and has strong fundamentals. CRISIL, India's leading credit rating agency, has maintained its P1+ rating for the Rs 20 crore short-term debt programme. According to CRISIL, "The rating continues to reflect Biocon's strong presence in the statins business and its leading position in industrial enzymes. Its R&D skills in fermentation technologies and its US FDA-approved facility for manufacturing Lovastatin also support the rating. These business strengths are complemented by Biocon's favorable financial profile, which is characterized by robust sales growth (compound annual growth rate of 50 percent since FY 98-99), healthy profit margins (24.9 percent at the operating level and 14 percent at the profit after tax in FY 02-03), comfortable gearing (0.56 times as on 31 March 2003) and healthy debt-servicing ratios. The rating strengths are, however, tempered to some extent by the large ongoing capital expenditure programme, the market-related risks on some of its new product launches in the biologicals segment and the flattening growth in the industrial enzymes sector." Be it the biopharma, agribiotech, or informatics segment, the chances for IPO successes look bright. But everyone is adopting a wait and watch policy till Biocon IPO takes off. Bharat Biotech, Biological E, Shantha Biotechnics, all need money to expand and grow. They have strong fundamentals, quality products, relationships, and vision. Some experts believe that the biotech IPO has the potential to attract collectively Rs 500 crore in 2004. Sentiments the key Why is the market for initial public offerings coming to life? In the US, the stock market sustained a rally since March. The Dow Jones Industrial Average went up by 16-17 percent and the Nasdaq Composite Index by 45 percent. That sentiment is believed to be one of the reasons for companies, who had put off their IPOs, to go public. The traditional financial measures like revenue, income, and sales may be important, but what pushes the case of a biotech company is the FDA approval. The companies, which are focused on new therapeutics, have found favor. For instance, Genitope is focused on the research and development of novel immunotherapies for the treatment of cancer. Its lead product candidate, MyVax, is personalized immunotherapy. CancerVax Corp. is focused on cancer therapies too. It is focused on obtaining approval of the Canvaxin therapeutic vaccine for the treatment of melanoma and colon cancer. Myogen Inc. is focused on the discovery, development and commercialization of small molecule therapeutics for the treatment of cardiovascular disease. Adolor is specializing in prescription pain management products. Its lead product Entereg (alvimopan) is being developed to manage postoperative ileus and its next product candidate is a sterile lidocaine patch in clinical development for treating postoperative incisional pain. It is not that their IPOs were oversubscribed. Nonetheless the ball has been set rolling. Positive Vibes Altogether, the biotech sector has positive vibes. According to the PricewaterhouseCoopers, Thomson Venture Economics, and National Venture Capital Association MoneyTree Survey, for the first time in seven years, biotech was the number one industry and attracted $873 million in VC money. About 17 drugs got the nod from the US FDA by July, against 20 in total last year. All these conditions only indicate that 2004 may be a good year for biotech IPOs Those actively considering IPO or have just launched â€¦ Amareshwara Agri Bio: A Hyderabad-based biotechnology company, it has decided to tap the capital markets with a Rs 25-crore IPO. The company has roped in Firstcallindia Equity Advisors as its financial advisors to navigate the IPO process. The IPO proceeds will be used for the expansion activities of the firm like development of GM crops, setting up of a biotechnology lab to carry on research and development in this segment. The company has a net work of more than 15,000 seed farmers and does contract production in over 20,000 acres of land under its various production programmes in the seed production areas of cotton, maize, sorghum, pearl millet, sunflower, hybrid rice, soybean and vegetable seeds. It has also plans to produce and market bio-control agents and bio fertilizers. Kolar Biotech: Company's aim is to develop NCEs with the help of research institutions/universities in India, acquire lead molecules through licensing, redefine pharmacological activity of molecules, analyze toxicological profile, offer promising NCEs to global pharma companies and offshore drug testing. Gland Pharma: Hyderabad-based liquid injectibles manufacturing company is planning to raise $25 million to meet its fund requirements for manufacturing capacity expansion, marketing support and a foray into regulated markets. The company presently has a paid-up capital of Rs 9.68 crore. It has got the US Food and Drug Administration (FDA) approval for its injectibles facility at Dundigal near the city. The approval was obtained for some of the products that the company will manufacture for Apotex Corp. Shanta Biotechnics: It had launched recombinant Streptokinase in November is planning to tap the capital market with an initial public offer. The proceeds from the issue would be utilized for expansion of capacity and also provide an exit route to existing equity investors. Morgan Stanley Mutual Fund has 7 percent stake while SBI Mutual Fund has a 3 per cent stake. Both these funds had invested Rs 50 crore for the 10 per cent stake. Of the remaining 90 per cent of the equity, Indian Promoters and Oman collaborators hold 45 per cent each. Ch. Srinivas Rao Biotech SizzlersBiotech Sizzlers There are several interesting products on horizon. According to IBM, in 2010, the pharmaceutical industry will not only make white powders; it will sell a variety of products and therapeutic healthcare packages that include diagnostic tests, drugs and monitoring devices and mechanisms, as well as a wide range of services to support patients. "Targeted treatment solutions" will deliver bigger shareholder returns than they have ever delivered before. Drug discovery and development will be underpinned by an understanding of how different disease function both at a molecular level and as part of a biological system. The molecular sciences will enable the industry to define diseases much more accurately and to create a collection of treatments and services for patients with specific disease subtypes, rather than making one-size-fits-all drugs for patients with similar symptoms but essentially different diseases. Similarly things will change of the agriculture and environmental side. There will be genetically engineered crops with better protection against diseases but also those with high nutrients and high yielding capacities. India is also taking several initiatives. We have seen the transgenic potato and rice developed here, indigenous Bt cotton, India's the world's only country to be working on buffalo genome, Pune University has developed VirGen, an indigenous virus identification software programme. So things are happening here too. On another count, biotech has been in news in the last three months for acquisitions, mergers, and IPOs. Pfizer Inc. entered into an agreement to acquire Esperion Therapeutics, a biopharmaceutical company focused on the development of high-density lipoprotein (HDL) targeted therapies for the treatment of cardiovascular disease. Esperion brings a novel approach to the emerging area of HDL therapy and reverse lipid transport for the acute treatment of cardiovascular disease. GE and Amersham agreed to merge. With this, GE wants to accelerate the development of molecular imaging and personalized medicine. We present to some of the top recall products of 2004 and why they would make a difference to the world. India's Bt genes Indians are known for copycatting. But not always. It is mainly because of brain drain of intellectuals. We do find talents working on different innovative ideas at various labs in India to come out with indigenous products. A team of scientists at National Botanical Research Institute (NBRI), Lucknow has indigenously synthesized two Bt genes Cry 1AC and Cry 1 EC, which may launch a tug of war with Monsanto's Bollgard. These two genes may bring down the actual production cost and put a full stop to the production and sale of spurious Bt cottonseeds, which is rampant at Gujarat. Gene scan in 3D Chromosomal disorders occur in 0.7 percent of live births. They increase in frequency with advanced maternal age. To provide equivalent accuracy and more comprehensive diagnostic capabilities, Biocept is developing a 3D HydroArray Chromosomal Disorders Diagnostic. This 3D HydroArray diagnostic is for prenatal diagnosis of a broad range of aneuploid and deletion disorders. Clinical trial results to date indicate that the diagnostic will be a major advance over currently available methods. Biocept currently offers two theme 3D HydroArray systems, the 3D HydroArray Apoptosis System, and the 3D HydroArray Signal Transduction System. In addition, Biocept can produce customized 3D HydroArray Systems to meet the needs of individual investigators and labs. Cancer-tackling antibodies Are you a victim of a deadly illness, cancer? Then look at Immunomedics Inc, which is developing, manufacturing and marketing innovative antibody-based products to combat deadly illnesses. It is in the process of developing antibody against cancers expressing carcinoembryonic antigen called CEA-Cide (labetuzumab). At present CEA- Cide is in Phase I/II clinical trials for the treatment of certain solid tumors. The antibody has been humanized, a process that depletes by about 90 percent all murine components in the antibody by replacement with human immunoglobulin, or antibody, structures. This antibody is in clinical studies as a naked (unlabeled) and a radiolabeled conjugate, for the therapy of diverse cancers expressing CEA, including colorectal, pancreatic and breast cancers. It's GM Canola now After making inroads in India by launching three hybrids of Bt cotton with product called Bollgard, Monsanto, a provider of agricultural products and solutions based at St Louis, US is entering Australia with Roundup Ready canola. It is also planning to take up field trials for GM corn in India. Developed by Monsanto Australia Roundup Ready canola got the approval from the Federal Government's Office of the Gene Technology Regulator (OGTR), Australia for commercial cultivation. GM Roundup Ready canola has undergone field trials in Australia and is tolerant to the herbicide glyphosate that will help in weed control while the canola crop is growing. It is a special type of herbicide tolerant canola developed using plant biotechnology. It offers farmers a safe and more effective way to control weeds in their crops than existing herbicide tolerant canola, including Triazine Tolerant canola, which is the current market leader in Australia. Triazine Tolerant canola makes up more than 60 percent of Australia's canola crop. Genetic skin care Are you suffering from a chronic skin disorder, Psoriasis? Don't scratch head or skin either. Genentech has developed a humanized therapeutic antibody, Raptiva, designed to selectively and reversibly block the activation, reactivation and trafficking of T-cells that lead to the development of psoriasis. Genentech has got the US Food and Drug Administration (FDA) approval in October 2003 for the treatment of chronic moderate-to-severe plaque psoriasis in adults 18 years or older who are candidates for systemic therapy or phototherapy. In clinical studies, Raptiva demonstrated a rapid onset of action, in some patients by four weeks, in the reduction of symptoms associated with psoriasis. Raptiva prevents T-cells from becoming activated and entering the skin. This, in turn, inhibits the process that leads to plaque formation. As Raptiva starts working in the body and plaque formation is slowed, psoriasis symptoms start to clear. 5-in-one vaccine from Serum Pain of injecting the vaccines at regular intervals is over. Now the babies can have relief of taking one vaccine instead of four against the deadly diseases Hepatitis -B and DPT. The scientists at the Pune based Serum Institute of India, a leading manufacturer of DPT vaccines are working on a combination vaccine, which is expected to be launched by end of first quarter of 2004. This combination vaccine will reduce the number of injections required for children from four to one. Serum, a Rs 450 crore vaccine manufacturing company is exporting its products to over 160 countries. Its path-breaking clinical trials include; a sero-conversion study to assess the impact of Measles Vaccine at 9 months of age and MMR vaccine at 15-18 months of age, Reacto-genicity and safety of Measles Vaccine with regard to neurological side-effects, Immunogenicity and Reacto-genicity of indigenously produced MMR vaccine, Sero-conversion following Rubella immunization in girls aged 9-11years, Reactogenicity of Rubella Vaccine in adolescent girls. Pesticide-killer protein Growers look at using traditional chemical pesticides and growing crops of genetically engineered for pest resistance to reap profits. Due to widespread criticism from environmental groups, government regulators, consumers, and labor advocacy groups, growers are finding it difficult to use these approaches. To overcome the problems faced by the growers, EDEN Bioscience Corp. has developed Harpin technology, which provides growers with a highly effective alternative approach to crop production that addresses these concerns. Messanger is the first of a series of products based on the Harpin Protein technology. Harpin Proteins induce disease resistance and promote increased yield in a broad range of agriculture and horticulture crops. Harpin Proteins induce the natural disease immune system and growth pathways inherent within each plant. Antidote for anthrax Human Genome Sciences Inc. has developed a human monoclonal antibody drug called ABthrax that protects against anthrax in animals. It is a synthetic antibody that neutralizes the main toxin produced by the anthrax germ. ABthrax could prove to be useful as an adjunct to or replacement for antibiotics currently used to treat anthrax. The human trials will only determine if the drug can be safely administered, as it is not considered ethical to expose humans to anthrax spores to determine its efficacy. The company has also got the USFDA permission for conducting clinical trials under the Bioterrorism Act of 2002. Biotech product pipeline for 2004 Insulin and Glucagon: Novolin, NovoRapid, Velosulin (Novo Nordisk), GlucaGen (Novo Nordisk) Growth hormones: GenoTropin (Pharmacia and Upjohn), Norditropin (Novo Nordisk), Saizen and Geref (Ares-Serono), HumaTrope (Eli Lilly), BioTropin (Bio-Technology General) and Serostim (Ares-Serono) Follicle-stimulating hormones: Follistim, Puregon (Organon), Gonal-F (Serono) Recombinant clotting factors: Recombinate (Genetics Institute), ReFacto (Wyeth-Ayerst), KoGenate/Helixate (Bayer), NovoSeven (Novo Nordisk/ZymoGenetics), BeneFIX (Genetics Institute), Mononine (Aventis Behring) Recombinant tissue plasminogen activators (rtPA): Activase (Genentech), Retavase/Ecokinase (Roche/Centocor), Solinase (Yamanouchi) Recombinant cytokines, interferons and colony-stimulating factors: Epogen (Amgen) Procrit/Eprex (Johnson & Johnson/Ortho Biotech), Neupogen (Amgen), Leukine (Immunex), Neumega (Genetics Institute), Infergen (Amgen), Intron A, Rebetol (Schering-Plough), Avonex (Biogen), Betaferon (Schering AG), Rebif (Ares-Serono) Therapeutic Monoclonal Antibodies (MAbs): Herceptin (Genentech), Rituxan (Idec), Orthoclone OKT3 (Johnson & Johnson), Simulect (Ligand/Novartis), Zenapax (Roche) Products in advanced stages of development: NovoMix 30, NN304 (Novo Nordisk), CMA-676 (Wyeth-Ayerst), Bexxar (Coulter/SmithKline Beecham), Zevalin (Idec/Schering AG), Panorex (Centocor), rhuMab-E25 (Genentech), Theragyn (Antisoma), CEA-Cide (Immunomedics) Narayan Kulkarni ]]> <![CDATA[Modern biotech research hub]]> https://biospectrumindia.com/news/95/1890/modern-biotech-research-hub.html https://biospectrumindia.com/news/95/1890/modern-biotech-research-hub.html Thu, 08 Jan 2004 14:04:00 +0530 CCMB State-of-the-art facilities, a talent pool comprising some of the very best scientists and freedom to work 24/7, at CCMB you are in the exosphere of cutting edge research in modern biology. Twenty-five eventful years after it was founded as a semi-autonomous center with the biochemistry division of Indian Institute of Chemical Technology (IICT) as its nucleus, the Centre for Cellular and Molecular Biology (CCMB) needs little introduction. Located in Hyderabad, the quiet environs of the campus has 78 scientists leading cutting edge research in the frontier areas of biotechnology. And in a campus spread over 6.4 hectares a team of 585 including research staff, post doctoral fellows, PhD students, project staff, technical support and administration untiringly works 24/7. When Lalji Singh entered the campus as CCMB director in 1998 he encountered CCTVs flashing the message: "No water supply after 6 pm". He recounted by saying that no water supply means we are asking the scientists to stop work and go home at 6 pm. Water is critical to research labs. Singh on his first day at CCMB called the maintenance department meeting to figure out where all the water was going when there has been no cause for additional water requirement. In the days to follow the culprit, a leakage in the supply, was discovered and fixed resolving a long-standing problem. Singh believes that making the best of the research facilities available to scientists is 50 percent insurance that we will be in the forefront of emerging research areas in biotechnology. And his efforts to provide that 50 percent have continued till date. Said Singh, "There was a time when scientific research used to drive new technologies but today it is new technologies that are driving science. It is important to upgrade the infrastructure to be in tune with the latest developments. This allows the scientist to carry out research in the new areas and at the scale unthinkable before." He went on to create national level infrastructure facilities including a transgenic gene knockout mice facility at the cost of Rs 5.76 crore. CCMB today boasts of in-house facilities for digital imaging, DNA microarray, proteomics, X-ray crystallography, high throughput DNA sequencer and analyzer and fluorescence activated cell sorter among others. The future of research in biotechnology is beyond imagination. However, according to Singh there is no reason why India cannot be in the forefront. "Given our biodiversity we have everything right from infectious diseases to diverse human genes. We need to give our scientists a chance," he said. High quality research relevant to society and oriented towards commercialization has been the clear objective set by the institute's founding-director Dr PM Bhargava. Singh has accelerated the momentum. National and international collaborations have been forged. Research institutions, universities, hospitals, pharmaceuticals, biotech and IT companies along with organizations and institutes such as NIH, USA and Pasteur Institute, Paris, all form a part of this collaborative arrangement. However, in a scientific institution the real challenge lies in providing leadership and guidance in the emerging research areas. Singh took the challenge head-on. When CSIR refused the Rs 2 crore requested for Singh's research project, "Human Genome Diversity", it increased his determination to go ahead with the project sans financial support from the government. His creative approach to the problem saw CCMB enter into MoUs with the universities and academic institutions. The MoUs ensured that each student who comes over to CCMB for a post graduate program brings 100 blood samples from the tribal population of his/her geographical area and the work carried out on these samples becomes a part of the student's post graduate program. Today, this initiative for research on population genetics has taken a life of its own. The number of universities CCMB has signed MoUs with has gone up to 12 and the prohibitive cost of collecting blood samples have been brought down to nearly nothing. "We also took up new areas of research such as drosophilia genetics and developmental biology, gene silencing, molecular analysis of human genetic disorders and protein secondary structure prediction along with participating in the CSIR network projects," said Singh. According to Singh, the publication record of CCMB is on an upswing and the institute's record of international patents has also improved. "Ninety percent of the 75 research papers written every year are accepted in international journals such as Lancet, Journal of Cell Science and Journal of Medical Genetics. And in 2002-2003 we filed for three Indian and 10 foreign patents," informed Singh. He added, "It won't be long before another two CCMB facilities will go functional." The Laboratory for the Conservation of Endangered Species (LaCONES) is 90 percent complete. This seven acre satellite facility of CCMB is conveniently located near Nehru Zoological Park in Attapur village and a five acre facility for Cell and Tissue Engineering is coming up barely 2 km from CCMB premises. However, one facility which CCMB needs badly is a multi-purpose seminar complex. "The hall which we use for seminars and meetings with a seating capacity of 80 is inadequate as CCMB has grown manifold and in various dimensions since we moved into our campus 16 years ago. Its time we should get that too," said Singh. What the CCMB scientists sayâ€¦ Dr N Madhusudhana Rao Research area: Novel cationic amphiphiles as transfection agents; hybrid biological agents "I have been here for last one-and-a-half decades and enjoy my work here because of the permitivity the organization allows. As far as the support from the government in the areas of my work, everybody is learning on how to realize the potential of the work in the market place. But today the ride to a commercial house for a working scientist is rough. CCMB is a great place for a scientist. Dr Ramesh K Aggarwal Research area: Genetics. He is exploiting the power of advance DNA marker tools in the area of agriculture, wildlife conservation, germplasm characterization, and crop improvement and medical diagnostics; and basic research to understand the molecular basis of temperature dependent sex determination. "I cherish my 16 years at CCMB. I feel proud of the fact that I was part of the research team that developed the first DNA fingerprinting technology of the country, which has now revolutionized the forensic work and has led to the creation of a separate center for DNA fingerprinting technology. In fact, the best thing that happened to me after my doctoral work at HAU, Haryana is CCMB." Dr Ch Mohan Rao, deputy director, CCMB Research area: Protein folding in health and disease; biophysical studies on intact biological systems "It is one of the finest research institutes. I was trained in chemistry and did my PhD on Photoacoustic Spectroscopy, which included modification, fabrication, and software writing for the spectrometer. Over the years, my research work has moved from spectroscopy to biophysical chemistry, molecular biology and medicine. I was able to do it because of the intellectual and cordial interpersonal interaction at CCMB. CCMB is also unique in its centralized instrument facility that offers all the advanced technology to every scientist in the institute." Dr R Sankaranarayanan Research area: Structural basis of the editing mechanism in a class II tRNA-synthetase "As CCMB is a modern biology lab it lacked the structural biology component. It was decided that this area be strengthened, hence I joined in March 2002. The thing that impressed me most in CCMB in the recent past is setting up of the X-ray facility. It was done in a record time of a few months with a very good coordination from administration, purchase and instrumentation. We have already solved a couple of structures using this facility. I would say, our facility is on par with facilities in western countries and it is only a matter of time that our laboratory becomes a significant contributor in the field." Nandita Singh (CyberMedia News Service) "Biotech should go mission mode"Dr Lalji Singh, director, CCMB in an exclusive interview to Nandita Singh comments on the need for India to realize its potential in biotechnology. Where does India stand in the field of biotechnology? India has an inherent strength in its biodiversity. We have it allâ€”be it plant diversity, animal diversity or human genome diversity. India can be in the forefront of biotechnology. We have the potential. However, we need to work on that potential. We lost out on the genome sequencing project. Now, the next challenge is how to determine the function of genes. Out of the 40,000 genes we know the function of barely 1,000. To be in the reckoning in delineating the gene functions we need to be in tune with the R&D worldwide. How do you think India can realize its potential in biotechnology? We need to go mission mode. The way we took space program on mission mode, the way we took nuclear defense on mission mode. We need to make the latest technology and research facilities available to our scientists. We need to designate some of CSIR labs as national levels research facilities and bring it on par with the best in the world. Having one CCMB is not enough. We need to have an integrated research grant system for our scientists where they can send in proposals as if all the technology in the world is available to them and then they should be assigned to the most appropriate lab for their research. We need to create a strong resource centre tree structure in the country, which reaches out up to the village level. These days technology drives science, not the other way round. So we must acquire new technologies at an early stage. This is an investment we need to make. A concerted effort is must. One has to realize the value of biotechnology. IT (Information Technology) is India today and BT (BioTechnology) is Bharat Tomorrow. To be in the reckoning what research areas we need to strengthen? There is so much of interesting development happening and we need to be there in all of the areas. Our ultimate objective is to make use of the knowledge to reduce human suffering. Bioinformatics, Microarray, Proteomics, Nanotubesâ€¦ it pays great dividends if we acquire new technologies in their developing phase and capitalize on them. Also, we need to look at our research grant system and integrate it instead of putting our resources in small projects. Unless we come up with a system to tap excellence from the remote corners of the country we are not utilizing the potential of the country. At CCMB what are the areas that you think will pay good dividends in the near future? All that I have mentioned so far and a few more. Since the time I have taken over from Dr PM Bhargava I have concentrated on building up the momentum. Today, you just have to take a look at the facilities that we have at CCMB. In the near future and far future too, biology as a science will get its rightful due and will not be limited to drug discovery. I have concentrated on making CCMB future compatible. However, still there is lot to be done. For example, currently we are struggling to create a 600 mega hertz nuclear resonance micro imaging facility so you don't have to kill the mouse. This will help us follow the impact of the drug every hour and the resolution can go up to single cell. I am hopeful that in the next financial year we will be able to create the facility. What are the other things in pipeline at CCMB? We want to create a biological level 4 containment facility. It is Rs 62 crore project yet to be passed by the planning commission. We also need a sophisticated microscope facilityâ€”an atomic force microscope to determine the structure of the nanotube. This is an emerging area with a great future impact. Today's research is more of a collaborative effort it requires physicists, chemists, engineers and biologists to come together on a platform. What are your expectations? After creating the facilities that are now a part of CCMB I expect a number of breakthroughs from our labs. I have focused on creating a lot of networking within CCMB in terms of interaction between scientists from various disciplines. We are already getting representation in better journals. We continue to retain our focus on socially relevant research. We will also step up efforts to patent the research outcome from our labs. We want more scientists to work in the area of infectious diseases. And of course, the ultimate for any institute would be to produce a Nobel laureate. What is that one thing in biotechnology, which has the power to change the face of the country? Genotyping. The future medicine will be based on individual genotypes. And the big question is how will this medicine be delivered to each and every citizen in this country? We need to reach out to the gram panchyat level and create a gene database. The very thought that what all we can do with that information is so overpoweringâ€”right from disease distribution to effect of food habits to environmental impact will all be available and health management for us as a nation will take on a different meaning altogether. But of course all of it won't just happen on its own. It requires large scale planning and good execution. I think Andhra Pradesh will lead the way here too, an exercise to the effect is on in the state.   ]]> <![CDATA["Centralized Recruitment Cell at CSIR, a future possibility"]]> https://biospectrumindia.com/news/95/5897/centralized-recruitment-cell-at-csir-a-future-possibility.html https://biospectrumindia.com/news/95/5897/centralized-recruitment-cell-at-csir-a-future-possibility.html Thu, 08 Jan 2004 12:53:00 +0530 New Page 1 "Centralized Recruitment Cell at CSIR, a future possibility" Dr CM Gupta, Director, Central Drug Research Institute(CDRI), Lucknow   Dr CM Gupta, Director, Central Drug Research Institute(CDRI), Lucknow   Dr CM Gupta, Director, Central Drug Research Institute(CDRI), Lucknow   Q. What is the admission procedure followed by your organizations? Is there any remodeling on the cards? Dr CM Gupta: CDRI is a government funded non-profit organization. Employment opportunities for faculty recruitment are advertised in leading national dailies, scientific journals like Nature and Science and on CDRI-website to attract the best talent, interested in serving the nation. Ad-hoc appointments are also made through "Quick Hire Scheme" of Council of Scientific & Industrial Research (CSIR) in the case of extremely suitable candidates. Research trainees constitute a major workforce of the institute. For admission to the PhD program of the institute, the CSIR-NET qualified candidates can directly join the institute in their area of interest subject to consent from the institute's faculty to be the candidate's supervisor and director's approval. Considering the emergence of new specialized disciplines and their need in drug R&D, CSIR has recently permitted fresh engineering and medical graduates and M Pharma candidates with a valid GATE score to avail CSIR fellowships for pursuing a research career, in addition to CSIR lateral entry as senior research fellow. Besides, CDRI holds a written examination-cum-interview for selection of research fellows to work in grant-in-aid projects and research schemes. A "Centralized Recruitment Cell" at CSIR like DRDO and ICAR may be a future possibility. Dr Lalji Singh: For scientists: A large number of Indian scientists from all over the world apply to CCMB every year. We also advertise in internationally reputed journals giving details of specific expertise that we are looking for. All the potential job applicants are requested to give a seminar and have one-to-one discussions with our scientists. An expert committee (which includes experts from outside CCMB and outside CSIR) would short-list the candidates for interviews. Selection of candidates is based on their publication record, their research proposal that they want to take up in CCMB, suitability of the research proposal in the context of the on-going projects in CCMB and CCMB's aspirations to initiate new fields. For students: We select CSIR-NET or ICMR-JRF qualified students (about 250) for a written test. Those (about 50) who clear our written test would appear for interviews, which are done in two rounds. Success rate of the final selection is between 5 and 15. Although CSIR is fair and more flexible than any other government organizations in the country, yet there are many areas related to recruitment and promotion, which needs substantial improvement. Dr SK Brahmachari: Students come to IGIB either during their post graduation for two-six months as trainees or as PhD students. The trainees may apply by directly writing to Head, PME, Institute of Genomics and Integrative Biology (IGIB), Mall Road, Delhi - 110 007. They may also contact scientists directly either in person or through e-mail addresses available on our website (www.igib.res.in). Students who have cleared CSIR/NET examination are eligible for applying to join for PhD under the guidance of scientists at IGIB. Usually they have to be selected through an interview conducted once in a year. Currently, scientists are recruited on the basis of applications against advertisements, which appear in popular dailies and international research journals. The recommendations of previous employers and a proven track record in terms of publications of good impact are critical factors in the selection procedure. In future, we intend to make the admission procedure more hassle-free. The first few steps towards this like information dissemination through Internet and rapid screening of applications reducing the time between application to selection by as much as two-three months have already been implemented.   Q. What are your strengths? How are the government institutions planning to face the challenges posed by the private sector? Dr CM Gupta: CDRI is a unique combination of medicinal chemistry and biological sciences which is key to solving major challenges of new drug-discovery R&D. The institute's strength lies in its strong R&D and availability of wide-spectrum of properly validated in vitro and in vivo screening models in disease areas of national relevance. State-of-the-art infrastructure and technologies have further augmented the drug R&D program. These include new disciplines and expertise in combinatorial chemistry, high-throughput screening, genomics, proteomics, computational biology, bioinformatics and structural and molecular biology. The concept of R&D-based pharma sector is fast picking up and private sector has invested in basic research for the discovery and development of new drugs. However, only a few disease areas are covered by these pharma companies as their selection is directed solely by the market size and business opportunities. The priorities of government institutions, especially a drug research laboratory, are driven more by societal welfare and knowledge contribution. CDRI's major contributions are two antimalarial drugs, a contraceptive agent, a memory enhancer and a spermicidal cream. Such institutions are therefore not only centers-of-excellence but also provide centralized infrastructure to cater to the practical skill development of students and mid-career professionals. In fact, there have been continuous efforts in bringing the pharma industry and R&D institutions together. The major challenge posed by the private sector is the corporate culture, where timelines are met, appreciated and rewarded. For improving accountability in the CSIR system, regular monitoring at the level of headquarter had been introduced. Dr Lalji Singh: Our strength is in the academic performance of our scientists, their desire to apply the knowledge into some application, our infrastructure that helps to take up any project in modern biology and our support staff. Our instrumentation engineers, administrative and finance staff work over-time (without any extra benefits) to meet the deadlines. CCMB's strength lies in the fact that every one, whether he/she is a scientist or a support-staff, consider CCMB as his/her family. CCMB's real strength lies in it being an institute having one of the best infrastructure in the world to carry out basic research in the area of modern biology. We have a very strong instrumentation division and all our equipment are maintained, serviced and repaired in-house. CCMB has large intake of PhD students who are selected through a national selection process. Students prefer to join CCMB because it provides single occupancy hostel facility with kitchenette and attached bathroom, facility for gym and lounge, common washing facilities, solar water heating and canteen facility for breakfast, lunch and dinner. The institute and all the services operate round the clock. We provide transport to students and scientists at late hours to drop them at their residences. Most of the facilities at CCMB are centrally operated by trained technical staff. Everyone including students are free to go to any floor and use any equipment, if it is not already in use, simply by entering into a log book. The institute has a very congenial atmosphere with freedom and discipline, where human dignity is held very high. There is no hierarchy here. CCMB also recognizes, promotes and rewards excellence. The research atmosphere is unique which is not easy for private sector to create. CCMB provides appropriate accommodation for its staff in a beautifully maintained campus close to the institute. CCMB provides transport for the children of the staff to take them to schools and colleges and also bring them back. All these features mentioned above make CCMB very unique in attracting the talent and retaining them. However, we do perceive the threat from private sector, which is prepared to pay any amount of salary to take the best persons from CCMB. Everyone cannot resist this. But, because of the features mentioned above, the institute does attract talent from outside the country, in fact even more than what we can accommodate. We are strangulated by the rules formulated by our headquarters in Delhi causing enormous delays in procuring things and marching ahead because of the interference from the headquarters and essentially because CSIR follows typical government rules. This is partially a matter of concern because we are trying to compete internationally where time is money. Private sector, of course, implements things much faster and time is very valuable for them. Unless the things are improved, we might lose talent because they do not have patience to wait forever. An institution like CCMB needs more autonomy. Dr SK Brahmachari: IGIB offers excellent infrastructure and our mandate encompasses interesting areas of research. But our true strength is a unique environment where the researcher can strike an optimal balance between fundamental research and that oriented with application potential.   Q. Red-tapism is often said to be the major stumbling block faced by the researchers in government organizations â€¦ Dr CM Gupta: Organizations like CSIR, ICMR, ISRO, and BARC are premier institutions with considerable autonomy in their functioning and no visible red tapism. Dr Lalji Singh: This, in fact, is a major concern. However, CCMB is much more flexible in functioning and faster but still not up to the mark. CSIR laboratories have a lot of autonomy, which gives power to the director to speed up the process by convincing the administration. We do it by making administration a part of the day-to-day interaction with the scientists and trying to convince them that their first priority is not just to follow the rules but to help the director and other scientists in achieving the objectives of the institution. In doing so, if there is necessity to bend the rules, they should do so and strengthen the hands of the director. They should fully understand what work scientists do and what harm delays can cause. The staff at the managerial level, such as administrative officer or a stores and purchase officer or finance and accounts officer, when they join CCMB, around, showing them the facilities and educating them what it means if the equipment goes out of order and remains idle for a month. This convinces them and they should march on along with the director. We at CCMB have practically no problems with the administration. However, we have serious problems with the administration at CSIR headquarters in terms of speed with which decisions must be taken; things are improving but it has a long way to go. If this is not improved further, I am afraid we will lose out to the private sector. Dr SK Brahmachari: Indeed, the slow movement of papers has been a crippling factor to the rate at which decisions can be implemented in government organizations. At IGIB, we have initiated concrete and long reaching measures to correct them. Networking the institute and computerization of many processes was one of the first steps taken in this direction. More long-term steps, which are aimed at changing the underlying process, have also been initiated. People trained at leading management institutes have been brought into the organization to take a fresh look at the procedures, simplify them where possible and revamp them wherever necessary with input from the members of the organization.   Q. How do the Government institutes compete with the private sector on the facilities, growth prospects, salaries and environment offered to researchers? Dr CM Gupta: CDRI is one of the best institutions in the country with respect to the facilities, growth prospects and environment for research. The Ninth Five Year Plan is a witness to the modernization of this laboratory. The institute has acquired many sophisticated equipment like robotic multiple organic synthesizers, high-throughput screening facility, structural biology facility, LC-MSMS facility, confocal microscope, and microarray facility. The institute has a conducive environment for research with incentives, empowerment, recognition and skill upgradation of its staff. The promotion policies for regular staff as well as research fellowships are also revised from time to time. The new recruitment and assessment scheme introduced in 1981 has since been revised and implemented as MANAS for the benefit of the employees. Research fellowships JRF/SRF/RA etc have also been revised to attract interested and deserving candidates. There can be no comparison of salaries between the two sectors but the salaries offered to the scientists are the best in a government set-up with ample opportunities and freedom to learn and work. Dr Lalji Singh: As of now, no single private biotech company in India is as well equipped as government labs. CCMB is one of the most well-equipped lab in the country and we do not expect any competition in the near future. Furthermore, much of our work is academic in nature, which has no counterpart in the private sector. Regarding salaries, ours are far below those paid by the private sector. But, scientists still join us because we provide facilities for their research and create suitable environment around them. Only when we hire competent software engineers, we face stiff competition due to poor salary levels. Our scientists are encouraged to apply for research grants to other organizations, other than CISR, within the country and abroad. As far as CCMB is concerned, we have been internationally competitive in bringing huge international grants for basic research. Our external cash flow is more than 50 percent of our annual grant, which is quite satisfying. In fact, our scientists prefer to compete for international grants because they do not have to give monthly progress reports and fill up hundreds of forms. For international grants, they have to give reports only annually and the final report to be submitted after the completion of the duration of the project. CCMB carries out high quality basic research, which leads to applications. In India, private sectors hardly spend any money for carrying out basic research. Dr SK Brahmachari: Government institutes and the Indian private sector establishments span a wide range in terms of facilities. But the best government organizations offer facilities superior to the best private sector establishments at present. Moreover, government organizations like CSIR have a large network, which enables optimal utilization of pooled resources. Growth prospects have traditionally been better in private organization but with the increasing need to break out of time-bound promotion patterns, the trend is likely to change. Salaries are relatively lower in government organizations but the freedom and creativity nurtured, factors, which are very critical in research, by the environment in a young and growing research institute like IGIB still attracts the best talent. Q. By and large what do the institutions look for in the potential candidates and what do they expect from its researchers? Dr CM Gupta: The candidates are expected to have a good grasp of the basic subject and ability to pick up related areas, in addition to a good practical hand and observation skills. Since drug development is a multidisciplinary activity, the ability to work in a team would be an added asset. A strong commitment to the organization would be sufficient to fulfill the expectations of the institute. Dr Lalji Singh: We look for scientific performance, novel ideas, integrity, ability to provide leadership, ability to work in a team, desire to achieve goals in shortest-time possible and desire to apply the scientific knowledge into human cause. Dr SK Brahmachari: Originality and an innovative approach in research, the ability to work in a team are appealing qualities while sound scientific knowledge is a prerequisite. Scientists who are proud to work in India and see themselves as a part of this country's progress are valued members of IGIB. When IGIB hires a young researcher, we try to see if he has the potential to grow into scientific figure of international repute in future. Q. How do you see the opportunity for researchers in the government labs growing in the future? Dr CM Gupta: All national research laboratories in the country are being continuously refurbished with regard to modern infrastructure. The aim is to attract the best talent and build capability for new technology absorption. Dr Lalji Singh: It will grow at much faster rate. Several new institutes are coming up and many old ones are also initiating new fields in order to be in the forefront of biotechnology. Dr SK Brahmachari: By leaps and bounds. The research scientist sitting in a government lab is going to enjoy the rewarding experience of valuing his knowledge and capitalizing on it when the biotech industry comes knocking on his door with the impending IPR and patent regime. Q. Would you also encourage scientists to become entrepreneurs in future and what are the steps that you are taking or intend to take? Dr CM Gupta: Yes. The scientists entrepreneur scheme, a pioneering scheme was launched by CSIR with the objective to generate a cadre of entrepreneurs amongst CSIR scientists and its scope was further extended later to include other aspects of knowledge base such as consultancy and software. There are many scientists from CSIR laboratories, IISc and other institutions who have opened their own industry. Dr Lalji Singh: CCMB offers consultancy to many companies. CSIR has a system for any scientist to become an entrepreneur. Dr SK Brahmachari: CSIR and IGIB have already moved ahead in this direction. CSIR allows a scientist to pursue entrepreneurship opportunities. We have examples where scientists from IGIB have indeed done that. Q. Would there be increased private-public cooperation in research (i.e., scientists allowed to work for private firm and be allowed back or vice-versa? Dr CM Gupta: Since drug discovery and development involves large scale organized efforts, collaboration between private-public sector would promote better positioning especially for the 1,500 small scale pharma units currently in the country. There is a global trend towards alliances, mergers and acquisitions by major pharma companies also. A number of industry sponsored projects are taken-up by CSIR laboratories and scientists are permitted to work as consultants for private firms as per CSIR guidelines. Dr Lalji Singh: Yes Dr SK Brahmachari: IGIB has very aggressively pursued private-public partnership in research. Scientists from IGIB have indeed already moved to the industry and are welcome to join back if they wish to do so. We have two models already in place: Genomed, a knowledge alliance with Nicholas Piramal Ltd is well on its way to patenting SNPs, single nucleotide changes in the DNA which can be of diagnostic value. The Center for Genomic Applications (TCGA), setup with the participation of government funding agencies and The Chatterjee Group will provide services to researchers all over the country. A researcher in IGIB can enjoy the pleasure of working on fundamental problems in a government research lab and at the same time participate in the more goal bound prospects of a private establishment.   CSIR CSIR has a network of 40 laboratories and 81 field stations/extension centers/regional centers all over India to undertake R&D in several disciplines including biotechnology. It currently employs 10,000 highly qualified multidisci-plinary professionals. Rolly Dureha ]]> <![CDATA[BioSpectrum Awards - 2003]]> https://biospectrumindia.com/news/95/8068/biospectrum-awards-2003.html https://biospectrumindia.com/news/95/8068/biospectrum-awards-2003.html Thu, 08 Jan 2004 12:31:00 +0530 BioSpectrum's first ever Awards for the biotech industry were presented on 20 December 2003 in Bangalore. A report. BioSpectrum Awards Life Time Achievement: Prof. MS Swaminathan Person of the Year: Ms Kiran Mazumdar-Shaw Entrepreneur of the Year: Dr Krishna M Ella State of the Year: Andhra Pradesh Product of the Year: AVADIS "Success is one percent inspiration and 99 percent perspiration." Success is also appreciationâ€”both for measure of success and enabler for greater success. That was the philosophy behind BioSpectrum Awards. With this theme, the stage was set to felicitate the achievers of the biotech industry. Well-known biotechnology expert and Father of India's Green Revolution, Prof. M S Swaminathan was conferred the magazine's "Life Time Achievement" Award, while Ms Kiran Mazumdar-Shaw, Chairperson and Managing Director of the Rs 286-crore Biocon India, was honoured with the "BioSpectrum Person of the Year" Award. Accepting the Award from Editor-in-chief of BioSpectrum, Shyam Malhotra, Prof. Swaminathan, UNESCO Cousteau Chair in Ecotechnology and Chairman MS Swaminathan Research Foundation, said, "There is a lot to learn from children and a lot to learn from this young child, BioSpectrum, too." He stressed the need for synergy between technology and public policy. India can make rapid progress if we have the encouraging and enabling environment. In early Sixties everyone thought India cannot feed itself. But the hard work of scientists, farmers, and public policy proved all the predictions wrong. Great achievements are possible and biotech revolution is one, which is most relevant to bridge the gap between our natural resource endowments and the ability to convert these endowments to jobs and be meaningful to people. We have the opportunity to become #1 and at the same time ensure that the fruits reach everyone. Year 2004 has been declared as the 'Year of Scientific Awareness'. Everyone should be a part of that initiative." Prof. Swaminathan was conferred the Life Time Achievement Award for his tireless crusade using the tools of biotechnology to usher in a hunger-free world and make the earth a "Bio-Happy" place for the current and future generations of humanity. "This gesture by BioSpectrum is very important and I feel proud that I am being honored by another pioneer," said Kiran Mazumdar-Shaw, Chairperson and Managing Director, Biocon on receiving Biospectrum's "Person of the Year" Award. She also expressed that people and activity that bring about change always inspired her. "India is a country that is changing rapidly and each and every activity and person who can bring about the important change will make a big difference to this country," told Mazumdar-Shaw. The Award was to recognize her passion for innovation and single-minded pursuit of excellence, for pioneering biotechnology with the launch of Biocon India in 1978, her entrepreneurial spirit and strong leadership that is driving the nation to seek its rightful place in the global biotechnology arena. Ms Mazumdar-Shaw heads the country's largest biotechnology company Biocon and has been in the forefront of developing the nascent industry. She has been consolidating the industry by launching the Nasscom-equivalent of this industry called the Association of Biotechnology-Led Enterprises (ABLE) which is now playing a leading role in taking up biotech issues. Under her leadership, Biocon itself is poised for doubling its growth with expected revenues of over Rs 500 crore in 2003-04. Biocon's proposed IPO in early 2004 is likely to stimulate global investor interest in India's nascent biotechnology industry. Awards in three other categories also were bestowed. These being "Entrepreneur of the Year", "State of the Year", and "Product of the Year". The Awards were conferred on Dr Krishna Ella, CMD, Bharat Biotech International Ltd, Hyderabad; Andhra Pradesh; and Strand Genomics respectively. Dr Krishna M Ella was chosen the "Entrepreneur of the Year" for his visionary leadership and entrepreneurship which has led to the setting up of a world class institution in Bharat Biotech International and the launch of a slew of products in his pursuit to ensure "Healthy Tomorrow" for all the global citizens by developing and providing affordable, safe and effective healthcare solutions to combat most dreaded illnesses. "There are people in the slums who are suffering from Typhoid. They are the people who get dog bitesâ€”rabies. Today we are not able to bring down the prices of rabies vaccines below Rs 200. We have to find solutions for these people," said Dr Ella. The Recipients of BioSpectrum Awards 2003 From left to right: Prof. Vijay Chandru, Chairman, Strand Genomics; Dr Krishna Ella, CMD, Bharat Biotech; Ms Kiran Mazumdar-Shaw, Chairperson and CMD, Biocon; Prof. MS Swaminathan, UNESCO Cousteau Chair in Ecotechnology and Chairman MS Swaminathan Research Foundation; and BP Acharya, Secretary, industry and commerce, Andhra Pradesh. Mr BP Acharya, Secretary, Industry and Commerce, Andhra Pradesh, who has been driving the biotech initiatives of the state, received the BioSpectrum "State of the Year Award", on behalf of the State. Accepting the Award, he expressed the dream of Chief Minister Chandrababu Naidu and said, "The State should move even faster and harder on its policies to implement and encourage biotechnology and become not just the best in India but also one of the best in the world." The Award was in recognition of the visionary leadership of Chief Minister N Chandrababu Naidu and his team, which is transforming Hyderabad and the entire state into one of the country's hottest biotech destinations. The leadership position has been achieved through a combination of making available world class infrastructure, investor-friendly policies and an enabling environment that promotes and sustains entrpreneurship in the cutting edge field of biotechnology. Strand Genomics represented the spirit of innovation in biotechnology by turning up as a complete team to accept the Award for the best product, which went to their data mining and visualization platform AVADIS. Since its launch, AVADIS has been making waves. At least half a dozen licenses of this software product has been sold in a very short time. Strand Genomics is considered to be one of the biotech hot shops and has a unique position in the Indian biotech industry. It is the country's first pure play bioinformatics company and was started by a core team of academicians from the Indian Institute of Science, Bangalore. Prof. Vijay Chandru, Chairman of Strand Genomics, voiced that the product was a result of the efforts by the team to use the best of computer science knowledge to solve biotech problems and said that the Award was proof of the success of the thesis. He also said that there would be a stream of products flowing out in the years to come based on this platform technology. BioSpectrum instituted the Awards to recognize outstanding contributions by individuals, companies and organizations to stimulate the growth of biotechnology in India. The Awards were selected by a jury headed by Dr D Balasubramanian, Director (Research) of LV Prasad Eye Institute, Hyderabad. The other members of the Jury included Utkarsh Palnitkar, Director and Head of life sciences practices, Ernst & Young, Nitin Deshmukh, the Director-General of the Association of Biotechnology-Led Enterprises (ABLE), Shyam Malhotra, Editor-in-Chief, Cyber Media publications, and Abraham E Mathew, Chief Editor of BioSpectrum. Photo GalleryThe audience at the start of the Awards ceremony Quote of the Night The audience at the start of the Awards ceremony. "Welcome to the 1st Awards Nite for Biotech Industry": Abraham E Mathew, Chief Editor of BioSpectrum. Enlightening: Shyam Malhotra, Editor-in-Chief, Cyber Media publications, follows tradition. "Success is appreciation and encouragement too": Shyam Malhotra elaborates on the Awards. Honoring Prof. MS Swaminathan (on left) with the Life Time Achievement Award. Felicitating Ms Kiran Mazumdar-Shaw (on right) with the Person of the Year Award. Dr Krishna Ella (on left), Entrepreneur of the Year, receives the award from Aseem Chauhan (on right), chairman, Amity Foundation. BP Acharya (on right) accepts the State of the Year Award on behalf of the AP Government, from Prof. MS Swaminathan. Prof. Vijay Chandru (second from right) and his team receive the Product of the Year Award from Nitin Deshmukh (extreme right), director-general, ABLE. "There is a need for synergy between technology and public policy. India can make rapid progress if we have the encouraging and enabling environment. â€¦ Year 2004 has been declared as the 'Year of Scientific Awareness' Cyber Media should play a key role in creating the awareness." â€” Prof. MS Swaminathan "It is a privilege to receive an Award before people like Prof. Swaminathan and Mazumdar. â€¦ Today the prices of rabies vaccines are very expensive. We have to inspired to develop products for the masses." â€” Dr Krishna M Ella "The product was a result of the efforts by the team to use the best of computer science knowledge to solve biotech problems. The Award was proof of the success of the thesis. â€¦ There would be a stream of products based on this platform technology." â€” Prof. Vijay Chandru "This gesture by BioSpectrum is very important. â€¦ India is a country that is changing rapidly and each and every activity and person who can bring about the important change will make a big difference to this country." â€” Kiran Mazumdar-Shaw "Chief Minister Chandrababu Naidu wants more. Not just become the best state in India but also one of the best in the world. â€¦ The State should move even faster and harder on its policies to implement and encourage biotechnology." â€” BP Acharya. Audience at the start of the Awards ceremony. Abraham E Mathew presents mementos from Mahindra Industrial Park Ltd to the Dr Ella, Mazumdar-Shaw, and Prof. Swaminathan. "Thank You": The closing remark from Executive Editor N Suresh. Clicked: The Award Recipients join for a photo shoot. ]]> <![CDATA[Managing indigenous and exotic plant genetic resources]]> https://biospectrumindia.com/news/95/1155/managing-indigenous-and-exotic-plant-genetic-resources.html https://biospectrumindia.com/news/95/1155/managing-indigenous-and-exotic-plant-genetic-resources.html Thu, 08 Jan 2004 12:27:00 +0530 NBPGR The National Bureau of Plant Genetic Resources (NBPGR) has added another feather to its cap! After pioneering the creation of genetically modified potato with enhanced protein content, scientists at NBPGR have developed transgenic rice having higher level of proteins. The gene inserted was AmA1 of Amaranthus (the same that was inserted in potato). AmA1 gene has been added to five rice varieties cultivated in India, including IR-72 and Pusa Basmati. Rice normally contains about seven percent protein and the gene addition is expected to improve the amount of protein and also the amino acid content. But farmers will have to wait for at least a year before they can grow the GM rice, as it has yet to be cleared by the GEAC. The Bureau scientists are now working on inserting the AmA1 gene into cassava and sweet potato, staple food of many poor people around the world, which are carbohydrate rich and protein poor. Established in 1976, NBPGR acts as the national nodal institute for acquisition and management of indigenous and exotic plant genetic resources for food and agriculture and to carry out related research and human resources development for sustainable growth of agriculture. It strengthens plant genetic resources management by maintaining a national database and networking with national active germplasm sites (NAGS), molecular characterization of promising genotypes, regeneration of plant material, introduction of elite genotypes, development of core collection and utilization of the genetic resources. Besides this, NBPGR has the authority to issue import permits and phytosanitary certificates. The bureau has the power to conduct quarantine checks on all seed materials and plant propagules (transgenic material) imported from abroad for research purposes. Informing more about the bureau, Dr BS Dhillon, director, NBPGR said, "Over the years, priorities on Indian agricultural structure have been changed a lot. We have seen the green revolution, now another challenge is knocking our doors. To meet these new challenges we are committed to undertake introduction, exchange and quarantine of plant genetic resources. Characterization, evaluation, documentation, conservation of crop genetic resources and promotion of their use, in collaboration with other national organizations, is also an area where we at NBPGR are working." He added, "Developing an information network on plant genetic resources is urgently required and we have accepted this challenge. Apart from this we conduct research, undertake teaching and training, develop guidelines and create public awareness on plant genetic resources. " With the advent of "New Policy on Seed Development" in 1988, mandatory requirements of issuing import permit before import of any seed/plant material in the country and ensuring phytosanitary standards was introduced. Based on its scientific strength and capabilities, the Bureau was identified as a nodal agency at the national level for this purpose. Also, to document the performance of promising germplasm and promote their exchange and use, the ICAR started the registration of potentially valuable plant germplasm at NBPGR. Optimistic of the biotech applications in agriculture, Dr Dhillon felt that there is a need of more effective interaction within research community as well as with the industry representatives. One of the key facilities at the bureau is the national research center on DNA fingerprinting. This was started in 1996 and since then it is working on developing experimental protocols and fingerprinting the crop varieties. Dr JL Karihaloo, project director and center in-charge said, "With the advent of molecular techniques for genotype characterization, it is strongly felt that DNA technology has tremendous potential in resolving cases of infringement of breeders and farmers rights and is also useful in assessing quality of plant material." It is notable that NBPGR has successfully implemented the Indo-USAID (1988) and Indo-UK (1989) projects to develop human resources and strengthen the conservation facilities at its headquarters and the regional stations. Talking about another facility at the bureau, Dr Dhillon said, "Established in 1996, the National Genebank (NGB) facility of NBPGR consists of 12 long-term storage modules with a storage capacity of 1 million seed accessions. Well-equipped cryo preservation and in vitro conservation facilities were developed to cater to the conservation of recalcitrant seed species and vegetatively propagated materials supported by the Department of Biotechnology. The NGB ranks fourth in the world in terms of germplasm holdings." "For strengthening the conservation activities at the regional stations, germplasm storage modules were installed and made operational at seven stations namely Akola, Bhowali, Hyderabad, Jodhpur, Shimla, Shillong and Thrissur during 1995-2002," he added. Keeping in view the strength and stature acquired by NBPGR over the years, ICAR has approved seven sub-projects of national importance under the World Bank aided National Agricultural Technology Project to it. Of these, two mission-mode sub projects started in 1999, namely, "Sustainable Management of Plant Diversity [NATP (PB)]" and "Household Food and Nutritional Security" were included in the Prime Minister's coveted Jai Vigyan National Science and Technology Mission. The Bureau is moving in tandem with the developments occurring globally. To have access to the latest information, a separate unit for computerized documentation namely Agricultural Research Information Services (ARIS) was set up in 1997. All the labs of headquarter and regional stations were connected by e-mail, and a home page was created. Complete automation of the library was also done. Recognizing the importance of plant genetic resources as a discipline, the Bureau in collaboration with the Postgraduate School, IARI started a MSc degree course in 1997 on this subject. For its dedicated and meritorious services to the nation, NBPGR was conferred the Best ICAR Institute Award in 1997. "Integrated effort needed for the industry" At NBPGR, issues like importing germplasm, conducting quality checks of imported transgenic material are decided, which are crucial for the industry. Today when expectations run high and challenges have taken a new shape Dr BS Dhillon, director, NBPGR, is all set to face them with a focused approach. Discussing this and much more with BioSpectrum, Dr Dhillon expressed his thoughts and ideas about the country's agriculture scenario. How has been NBPGR's experience in maintaining the quality of imports of plant material, germplasm and transgenic material? What are the challenges that it faces? Plant quarantine is high on our mandate. Maintaining the quality of imports is a big challenge in itself. We are very alert in checking the quality standards, especially in transgenicsâ€”we look for any terminator genes. At our bureau, we have world-class facilities for conducting these checks. The major challenge ahead of us is the wrong publicity spread about transgenics and export of germplasm. So far India has secured its diversity unlike any other developing nation which is a very motivating fact. But we need to focus on our growth. The division of plant quarantine, which is responsible for maintaining quality of such imports in India, consists of experienced scientists and well-trained technical staff in the disciplines of entomology, nematology and plant pathology (bacteriology, mycology, virology). There are well-developed procedures for a systematic and step-wise quarantine processing of germplasm in the well-equipped laboratories for each discipline. The most important facilities include soft X-ray plant, vacuum fumigation system, multi-gas detector, ambient air analyzer, hot water treatment, ultra-centrifuge, UV spectrophotometer, ELISA reader, deep freezer, etc. What have been the recent developments at NBPGR? Last year, under the plant exploration and collection of germplasm program a total of 141 plant explorations were undertaken across the country and 7,693 collections were made comprising of germplasm of horticultural crops and their wild varieties. Under the quarantine processing and clearance of germplasm we processed 89,916 samples of various crops for quarantine clearance. Out of these samples the imported samples were about 83,662 and only 6,254 were exported. These samples included true seeds, rooted plants, tissue culture plantlets, etc. Apart from these we are also focusing on our center's work on DNA fingerprinting. We are working on maintaining the DNA fingerprinting database and statistical analysis package. How are the ifs and buts on trangenics affecting the Indian industry? It is critical to reply to this, being the representative of this bureau. Growth has been affected in a negative way by the objections and hurdles, which came across India's first transgenic experience in the case of Bt cotton. Proper screening is essential in the case of transgenics and we have to follow the guidelines. But even after that, we need to consider the first hand feedback from farmers. We need to consider the Indian point of view also in transgenics. Moreover, I think in India, transgenics are in the primary stage, we are late starters as compared with other developing nations but we are not bad starters. What are the efforts required for increasing the pace of growth of the Indian agricultural industry? First of all, we need to tap the upcoming trends in the industry. Innovative ideas are required for this sector. But most of all, an integrated effort is needed among the scientist community. I think, all the ICAR institutes should come forward and exchange their ideas with each other for the growth of the industry. Linkage, in terms of industry and academicians, is important. I think that this part is still lacking somewhere. Decentralized structure can also improve the situation of the Indian agricultural scenario. How much has NBPGR contributed towards maintaining these linkages? We have developed a good network with different divisions of ICAR, IARI, Indian Institute of Horticulture Research and various other ICAR institutes. We have strong links with DBT, DST and Dept of Environment and Forests, various other agricultural universities, research foundations and NGOs for several collaborative programs. Apart from this, NBPGR is in touch with international agricultural research centers, FAO, UN Development program, World Bank and several other organizations dealing in genetic resources. Since plant quarantine is one of the major thrust areas at NBPGR, what are the on going projects in this division? What are the challenges that lay ahead? There are many projects going on at the moment. Quarantine processing of germplasm under exchange and supportive research is an eminent thrust area at the bureau. We are also focusing on seed health testing, especially the germplasm of various agricultural/horticultural crops for pest-free conservation. The national containment/ quarantine facility for transgenic planting material is also doing well at the quarantine division of NBPGR. Apart form this, diagnosis and development of seed certification protocols for management of seed transmitted viral diseases of grain legumes is another focus area. In terms of challenge, we need to deliver the allotted work on specific deadlines. In fact, delivering the research at right time is the biggest challenge ahead of us. What do you foresee in the future for the Indian bioagri industry? How is it going to develop in the coming years? The Indian bioagriculture industry is growing, but at a slow pace. It has to upgrade its strengths. Although there are lot of potential in India, but we need to tap that strength. The past few years have not shown any substantial increase in India's bioagri segment of industry, but it can be assumed by looking at today's scenario that things are catching up. The coming years will witness good growth in this segment. Faiz Askari ]]> <![CDATA[BioSpectrum Awards 2003 - Life Time Achievement Award]]> https://biospectrumindia.com/news/95/6949/biospectrum-awards-2003-life-time-achievement-award.html https://biospectrumindia.com/news/95/6949/biospectrum-awards-2003-life-time-achievement-award.html Fri, 12 Dec 2003 17:54:00 +0530 Life Time AchievementLife Time Achievement Dr MS Swaminathan Working for a Hunger-free, Bio-happy World The Life and Works of Dr MS Swaminathan, described as the Modern Gandhi It was a pleasant evening in the first week of January 1989 in the temple city of Madurai in southern Tamil Nadu. Most of India's leading scientists were mingling with a large group of young scientists and research students on the lawns of Madurai Kamaraj University. A large group of young scholars had gathered around one well-known agricultural scientist and every word of his was being lapped up by the eager audience. Out of the blue, one of the young scholars there shot this question at the scientist: What is your name, sir? There was a stunned silence all around. Every one expected a sharp rebuke from this world famous scientist. But there was a surprise. The scientist replied: My name is M S Swaminathan. Aren't you Rajeev, asked the scientist in a soft tone. Yes sir, replied the young scientist. Congratulations once again, said the famous scientist, for getting the Young Scientist Award. (Earlier in the day, Dr Swaminathan had presented Rajeev, along with 35 others the Young Scientist Award of the Indian Science Congress Association. He had presided over the function, which was the 76th annual gathering of Indian scientists). But young Rajeev did not get the message even after that. He continued: What is your area of specialization? (A question researchers ask each other frequently). Dr Swaminathan continued in the same soft-spoken voice: I work on wheat and rice. I had started work from potato. There was not a trace of irritation as he continued for some more time, answering every question thrown at him by the ignorant young scientist for the next 10 minutes. That in a way sums up the life and personality of Monkombu Sambasivan Swaminathan, widely acclaimed as the Father of India's Green Revolution in agriculture which transformed the 'nation with a begging bowl for food' to one of the world's leading exporter of foodgrains. In the past 78 years, not one of the millions of people who have interacted with him all over the world have ever seen anything but a smiling face on one of the humblest human being of our time. He has been hailed by the Time magazine as one of the 20 most influential humans of the 20th century. There were two other Indians on the Time list in 2000: Mahatma Gandhi and Nobel laureate Rabindranath Tagore. Simplicity is the hallmark of this great scientist. Even at 78, he keeps a punishing schedule, traveling around the world and remote corners of the country with his mission to make the world 'hunger-free' by 2007 and usher in an environmentally sustainable mode of development. He personally handles hundreds of emails received at home and office. Answers all the phone calls himself when he is in his chairman's room at the well-known MS Swaminathan Research Foundation, which he started with the $ 200,000 he received for being the first recipient of the World Food Prize started by the Food and Agricultural Organization (FAO) of the United Nations. And he makes spellbinding power point presentations in some of the hallowed portals of the world and the country, all by himself, about his latest mission. Thumbnail sketch of Prof. MS Swaminathan Position: Chairman and UNESCO Chair in Ecotechnology, MS Swaminathan Research Foundation, Chennai and Chairman, Pugwash Conferences on Science and World Affairs Date of Birth: 7th August 1925 Academics: PhD in agriculture from University of Cambridge (1952), BSc from Travancore University (1944) and in agriculture from Coimbatore Agriculture College (1947). Schooling at Native High School and Little Flower High School, Kumbakonam, Tamil Nadu. Family: Second of four children of Monkombu Krishna Sambasivan and Parvathi Thangammal. Wife is Mina Swaminathan, educationist. Have three daughtersâ€”Sowmya, a pediatrician at Tuberculosis Research Center, Chennai and her husband Ajit Yadav who is the well-known orthopedic surgeon at Apollo Hospital; Madhura, second daughter was India's first woman Rhodes Scholar and is now an economist and works at Indian Statistical Institute, Kolkata with husband VK Ramachandran, also an economic professor. Third daughter Nitya, is doctorate from University of East Anglia, UK and is married to rural development expert Sudhir Rao. Swaminathans have five grandchildren. Official Positions held: Director-general of ICAR and Principal Secretary, Government of India till 1981, DG of International Rice Research Institute, Manila (1982-88), President of IUCN (1984-90) and continues as UNESCO-Cousteau Professor in Ecotechnology at MSSRF, Chennai, and Chairman, Pugwash Conferences on Science and World Affairs. Other hats: Called the Father of Green Revolution and named as one of the 20 most influential persons of the 20th century by Time magazine. Now called the Father of Ecotechnology Awards & Accolades: Till December 2003, Swaminathan has been awarded 45 honorary doctorate from universities worldwide including the oldest one, University of Bologna, Italy, and others such as University of Bonn, Soka University, Japan, University of Massachusetts, US. Has been awarded Padma Shri (1967), Padma Bhushan (1972) and Padma Vibushan (1989) by Indian Government. Has been given at least 25 world famous awards so far including the Ramon Magsaysay Award (1971), Mendel Memorial Medal (1965), Albert Einstein World Science Award (1986), World Food Prize (1987) and the Economic Times Awards for Corporate Excellence (2002) He travels alone, without any personal assistant to keep tab of the numerous meetings he had agreed to. Just a look at his current schedule. On 26th November which was a national holiday due to Ramzan, Dr Swaminathan inaugurated and delivered the keynote address at the 10th anniversary celebrations of New Delhi-based NGO, Gene Campaign. He fielded numerous questions from over 20 journalists present there and gave half-a-dozen interviews to television crews, which captured every moment of his public appearance. After a frugal meal with the participants, he was at Krishi Bhavan (headquarters of the Agriculture Ministry) to chair a meeting of the National Task Force on Agriculture. Minutes after the meeting, he was at Gene Campaign director Suman Sahai's farm house on New Delhi's outskirts, listening to a soulful hindustani music rendition. He then traveled to the southwestern city of Manipal in Karnataka to attend the wedding of a friend's son, after changing two planes and taking the road to reach this remote town. He was barely at his Chennai home for the weekend before he set off early on December 1 morning to Namakkal, a town in the interior part of central Tamil Nadu to inaugurate a farmers' convention. Back in Chennai for a day or so, he is off to Geneva to attend a series of four lectures at the UN-organized summit on Information Society. Immediately on his return, he will be in Hyderabad to organize a public hearing of the views of all state governments for the Agriculture Task Force. From Hyderabad, he will travel to the eastern metropolis of Kolkata to chair a World Bank meeting on fisheries development. "I am trying to cut down my travel. But I can't say no to so many people who want to share their remarkable contributions with me," Swaminathan confessed on a late Sunday evening sitting with the BioSpectrum team at his Chennai home. The enthusiasm with which he talks about his current mission is infectious. India has come a long way from the time he helped to usher in the Green Revolution in the 1960 by introducing the high-yielding, dwarf varieties of wheat brought from his Nobel laureate friend Norman Borlaug. Today India produces close to 210 million tonnes of foodgrains from barely 50 million tonnes in 1970, with a lot of surplus to export. "We can't sit back and relax. We must now make more progress in agriculture on three fronts: productivity, quality and sustainability," advised the man describer by his Hungarian biographer Andras Erdelyi as 'The Man Who Harvests Sunshine'. Erdelyi's famous book which was released in 2002 and is now being translated into several world languages is titled, The Modern Gandhi: M S Swaminathan. He has shared his thoughts on wide-ranging topics close to his heart to two other authors in the last few years. M S Swaminathan: One man's quest for a hunger-free world by Chennai-based author Gita Gopalakrishnan and Scientist and Humanist by RD Iyer for Bharatiya Viday Bhavan stand out. Yet another tribute to him is the booklet, M S Swaminathan, the Face of Indian Agriculture brought out by his former colleagues through the Retired ICAR Employees Association, Hyderabad. He himself has shared his vision through three other volumes, Science and Agriculture: M S Swaminathan and the Movement for Self-reliance; From Rio de Janeiro to Johannesburg; and A Century of Hope: Harmony With Nature and Freedom from Hunger. Besides, he shares his thoughts regularly through the columns of the leading national daily, The Hindu. Quiet beginnings All the fame and success did not come easy for the global scientist whose family hailed from the backwaters of Kerala state. To be precise Monkombu village, in the Alapuzha district, is in the Kuttanad region or the "rice bowl" of Kerala. His father Monkombu Krishna Sambasivan, a trained medical practitioner, moved to Kumbakonam in Tamil Nadu for greener pastures. Swaminathan was born the second of the four children of MK Sambasivan and Parvathi Thangammal (two brothers and two sisters) on 7th August 1925. After his father's early death at the age of 39, the family took shelter in his father's elder brother's house back in Kerala. The big joint family lived together with modest means. Young Swaminathan was fascinated by the large-scale rice cultivation in the Kuttanad region and decided to pursue his studies in this field. He took a BSc degree in agriculture (1947) from Coimbatore College of Agriculture and completed post gradaute diploma in agriculture from the Indian Agriculture Research Institute (IARI), New Delhi in 1950. There are still some twists and turns in the saga of this agricultural scientist who almost gave up this field. "I was advised by my father's friend, a senior official in the Indian government, that there was no future in agriculture," he recalled. So Swaminathan appeared for the national civil service examination and he was selected for the Indian Police Service. Fortunately, around the same time he had also got a UNESCO fellowship for advanced study at Wagenignen University in The Netherlands. The agriculturist in him won over and he opted for the research career and went on to complete doctoral studies at Cambridge University in 1952. At Wageningen, he developed techniques to transfer genes from a number of wild varieties of Solanum plant and impart resistance to frost and nematodes in the widely cultivated potato crop (Solanum tuberosum). At Cambridge, he continued the work under the guidance of Dr HW Howard and earned a PhD for his thesis titled, "Species differentiation and the nature of polyploidy in certain species of the genus Solanum-section Tuberarium". Swaminathan also met his future wife Mina Bhoothalingam, a student of education and daughter of a senior Indian bureaucrat there. They became friends at Cambridge. And in 1955, they got married at a ceremony arranged by both families. Mina Swaminathan continues her career as a well-known educationist in India. Ideal teacher "Swaminathan has symbolized to me the definition of an ideal teacher and his teaching prowess goes far beyond classroom delivery. Any occasion of spending time with him has been an opportunity of education; and education delivered in a most interesting and unobstrusive way," says Dr VL Chopra, a former student of Swaminathan at IARI and former chief of ICAR and currently President of National Academy of Agricultural Sciences, New Delhi. Great diplomat "Swaminathan combines scientific and administrative capacities with great diplomacy. He was always very kind to his students and colleagues. He helped them in every possible way," remarked AT Natarajan, Emeritus Professor, Leiden University Medical Center, Ledien, Netherlands and Swaminathan's first doctoral research student. Human virtues "What have you learnt from MS Swaminathan?â€¦ You were his associate for the longest period," some one asked Dr EA Siddiq, now Distinguished Fellow, Center for DNA Finger Printing and Diagnostics, Hyderabad. His reply was simple and spontaneous: "Human virtues, science and the courage to speak up the science I learnt from him." A living legend " Dr M S Swaminathanâ€¦ is a living legend. His contributions to agricultural scienceâ€¦have made an indelible mark on food production in India and elsewhere in the developing world. By any standards he will go into the annals of history as a world scientist of rare distinction," said Javier Perez de Cuellar, Secretary General, United Nations in 1987. Brilliant leader "â€¦You have taught nations how to be self sufficient in their need for food just as you have taught farmers how to develop and enhance the productivity of their land. Your brilliant leadership has established a goal for the new millenniumâ€”a hunger-free world, an international structure of cooperation among nations, a determination to use the miraculous technology of our times to help those in need, for dynamism and compassion that has given new meaning to Franklin D Roosevelt's commitment to a better world where all nations will understand and strive for Freedom from Want," says the citation of the Franklin D Roosevelt Four Freedoms Medal presented to him in 2000. Helping hand The citation of the UNESCO Gandhi Gold Medal for Culture and Peace in 1999 reads: "outstanding work in extending the benefits of biotechnology to marginalized and poverty-stricken populations in developing countries, and in securing a sound basis for sustainable agricultural, environmental, and rural development." Fate tempted him away from core agriculture yet again a few years later. He had moved to the University of Wisconsin, Madison in the US as an assistant professor. Because of his expertise in potato, a local industrialist gave Swaminathan a tempting offer to become his potato chip factory's chief scientist at $ 14,000 a year to develop new varieties of the crop. He was barely getting $ 3,000 a year at the University. But the urge to serve the country brought him back to India in 1954. " I was thinking a lot about the famine in India and the dwindling supplies of imported rice after Japan occupied Myanmar (then known as Burma). What really hurt me was the restrictions on the use of rice. When my elder brother got married in 1947, there was a food control order. In a marriage, food could be served to a maximum of 30 people only. And there was a policeman waiting outside to count the plantain leaves on which the feast was served," Swaminathan recalled. Back in India, he did not get any job immediately. Later, one of his former teachers Parthasarathy gave him a temporary job at the Rice Research Institute, Cuttack, Orissa. Swaminathan had to give up his work on potato and work on rice instead. After a few years, he got a permanent job at his alma mater, IARI in the biology division, which eventually became the famous genetics department and formed the backbone of the Green Revolution. Ushering the Green Revolution Volumes have been written about the series of actions that finally led to the remaking of Indian agriculture. Even though wheat had been cultivated in the Indian continent for over 4,000 years, the production was very low. In 1947, the wheat production was just 7 million tonnes and the average productivity was barely 0.7 tonnes per hectare. India was facing widespread famine conditions in the 1960s and was heavily dependent on donations of wheat supplies offered by the US government under the PL-480 program. The low productivity was due to the wheat varieties widely cultivated in the country. These had long stalks which would bend and break due to the weight of the pods. This resulted in less photosynthesis and hence low yields. Also it took up more space and the number of plants per unit area was small. A section of the MS Swaminathan Research Foundation, Chennai. Swaminathan was thinking of ways to improve the yield. "I remembered a research paper by Dr Orville Vogel which I had read in 1958. Vogel had experimented on so-called Norin 10 dwarfing genes in Washington State in the US. One Dr SD Salmon, who had served in the US Army, had brought some wheat plants from Japan and the Norin 10 genes in it found its way to Vogel's lab," Swaminathan reminisced. From Norin 10, Vogel had developed a semi-dwarf variety, Gaines, which yielded nearly 15 tonnes per hectare. However, Gaines was a winter wheat which grew well only in the long sunshine days found in the upper Northern Hemisphere. In India, wheat was mainly sown in spring which got less sunshine. Swaminathan then heard about another American, Dr Norman Borlaug, who had developed a spring variety wheat and was working in Mexico. "I contacted Borlaug who was willing to give some of these varieties for growing in India. He also wanted to visit the field where it was grown. I was a junior scientist and it took nearly 18 months to convince bureaucrats in the Indian governments to get the permission to invite Borlaug to India," Swaminathan observed. The government process hasn't changed much even three decades later. Rest is history. Borlaug finally reached India in March 1963. The dwarfing genes were transferred to three wheat varietiesâ€”Sonora 63, Sonora 64 and Lerma Rojo 64 A. The varieties showed good results. Despite opposition from the system and colleagues, Swaminathan demonstrated the new varieties in some 150 experimental fields across the country. With good fertilizer inputs, the yield gains were enormous, at least four to five times. He was supported fully by the then Agriculture Minister C Subramanian. The national wheat production dramatically increased from 12 million tonnes to 17 million tonnes in 1968. The varieties caught like wild fire. Today, the nation's annual production is over 80 million tonnes. William Gaud of the US Department of Agriculture coined the term 'Green Revolution' to describe the unprecedented quantum jump in food production. Later, in 1970 when the phenomenal increase in petroleum products led to the hikes in the costs of fertilizers, a petroleum byproduct, and raised questions over the sustainability of Indian agriculture. "We have withstood these shocks very well," said Swaminathan. There have been many criticisms about the high cost and input based modern agriculture induced by the Green Revolution. Swaminathan said that he had warned about the indiscriminate use of these inputs to achieve unprecedented yields and has since been a great votary of sustainable modes of agriculture production. This is one of the missions of the MSSRF in the last decade. Swaminathan did not rest on his laurel at home. In 1981, he moved to the famous International Rice Research Institute (IRRI) in Manila, Philippines, as its director-general and pioneered the setting up of networks of agriculture research and extension services in a large number of developing countries. These networks in countries such as China, Egypt, Iran, Kampuchea, Korea, Myanmar, Nigeria, Pakistan, Philippines, Sri Lanka, Tanzania, Thailand, Vietnam and more owe it to his foresight. Swaminathan's global role has been recognized by the bestowing of at least 24 most prestigious awards by foreign governments and institutions till this year. Some of these prestigious ones include the Commandeur of the Order of the Golden Ark of The Netherlands (1990), the Ordre du Merite Agricole by France, the Unesco Gandhi Gold Medal, the Franklin D Roosvelt Four Freedom Award. He carries on with his work through MSSRF, situated in the southern suburbs of Chennai. The Foundation takes up activities, which works towards pro-nature, pro-poor, pro-women, pro-employment programs. The Foundation is trying to integrate the modern technologies of biotechnology and information technology to usher sustainable development in rural areas of the country. Swaminathan has been instrumental in the evolution of the International Convention on Biological Diversity and handled the much-acclaimed Rio de Janeiro Earth Summit and its follow up conference on sustainable development in Johannesburg, South Africa in September 2002. He has headed prestigious international organizations like the International Union for Conservation of Nature (IUCN) and is currently the head of the Pugwash Conferences on Science and World Affairs. Pugwash conference is an influential international group, previously headed by giants like Albert Einstein and Bertrand Russel. It seeks to eliminate nuclear weapons from the world. Swaminathan's current quest is for a new global ecological order. "A global ecological order involves harmony with nature. Harmony with nature will not be possible unless we achieve harmony with one another. How can we value and protect biological diversity if we do not nurture an understanding and love of human diversity in terms of gender, religion, language, ethnicity and political belief?" Swaminathan wrote in the afterword to Gita Gopalakrishnan's book on him. These words continue to ring every time he ascend the podiums in numerous meetings around the world and also in the villages and towns which he continues to visit regularly in carrying forward the message. BioSpectrum has actually been honored by Swaminathan's unconditional acceptance of the first Life Time Achievement Award. And we only hope that two other awards, Bharat Ratna by the Indian government and the Nobel Prize for Peace will add lustre and the selection committees honor themselves by bestowing these on the Man Who Harvests Sunshine. N Suresh and Nisha Kurian (CyberMedia News Service) ]]> <![CDATA[BioSpectrum Awards 2003]]> https://biospectrumindia.com/news/95/2747/biospectrum-awards-2003.html https://biospectrumindia.com/news/95/2747/biospectrum-awards-2003.html Fri, 12 Dec 2003 16:26:00 +0530 BioSpectrum Awards 2003 The search for Biotech greats The Chosen Ones Life Time Achievement Prof. MS Swaminathan UNESCO chair in ecotechnology, MS Swaminathan Research Foundation, Chennai and President, Pugwash Conferences on Science and World Affairs Person of the Year Ms Kiran Mazumdar-Shaw CMD, Biocon India, Bangalore Entrepreneur of the Year Dr Krishna M Ella CMD, Bharat Biotech International, Hyderabad Product of the Year Avadis By Strand Genomics, Bangalore Special Category State of the Year Andhra Pradesh Biotech is an emerging industry whose actual size was known accurately for the first time only in September 2003 when the first BioSpectrum-ABLE survey of India's Top Biotech Companies was brought out. Now there will be another first for the Rs 2,300 crore ($ 400 million) industry. Yes. The First BioSpectrum Awards to honor the movers and shakers of this industry. When did the idea to institute the first BioSpectrum Awards germinate? Not long ago. Even as the blueprint for the magazine was being put together exactly a year ago, in December 2002, there were a lot of internal discussions on how to play the role expected of the pioneering industry publication. Chief Editor E Abraham Mathew was very clear. BioSpectrum should not wait for long. It should honor the remarkable achievements of men and women who have given this industry the size and the shape and the platform for rapid future growth. He emphasized the importance of the similar role played by the sister publication DATAQUEST by instituting the annual IT Man of the Year in 1993 which has now become the most awaited event of the globally-talked about Indian IT sector. And the magazine will have the insights of the colleagues at CyberMedia who have pioneered the concept and taken it to lofty heights in a decade as the most coveted Awards for IT practitioners. So the decision was made. Of course, the BioSpectrum team was very clear. We have to be politically correct. We have to be in tune with the modern times. And we have to mirror the realities of the biotechnology industry. So the first category was chosen. BioSpectrum Person of the Year, not 'Man of the Year' as is the case with most other awards. And then the Life Time Achievement Award. There was a lot of debate about the third category: Entrepreneur of the Year. How is it different from the Person of the Year? The two categories were clearly different. Editor-in-chief Shyam Malhotra delineated the two awards. A growing industry, at its early stage of development, requires the support of a number of key champions who need not necessarily be entrepreneurs. The policy makers, the venture capitalists, the technology champions, the role models who believe in the inherent strength of the biotechnology sector and the evangelists of biotech. The Person of the Year was the best way to recognize the contributions of such people. And the Entrepreneur of the Year could be a person who has taken his or her company to great heights in the most recent period with innovative products and technologies. The two other award categories: BioSpectrum State of the Year and BioSpectrum Product of the Year were easy to decide. However, these were put in the special category for the moment to avoid choosing a few players among states again and again. Unless of course, all the 28 states and 6 Union territories push biotechnology to the forefront with innovative policies and practices. Jury selection As this was the first attempt, BioSpectrum team realized that almost every one in the industry would be a nominee for the awards in various categories. It was difficult to choose members who will have to face the embarrassment of having to sit out of the meeting room when their names were discussed. But there was a genuine biotech giant in Dr D Bala-subramanian who heads the research activities of the LV Prasad Eye Institute in Hyderabad. Dr Balasubramanian graciously agreed to chair the BioSpectrum Awards Jury as he wanted to contribute even more to the growth of the biotechnology sector by associating with the efforts to honor the giants of the industry. Mr Utkarsh Palnitkar, director and head of life sciences practices of Ernst & Young readily agreed to be another jury member. BioSpectrum couldn't have asked for more. At E&Y he has been having a ringside view of the biotech industry and also brings with him the global practices of the organization which has been honoring entrepreneurs for over a decade. The Jury - From left to right: Abraham Mathew, chief editor of BioSpectrum, Utkarsh Palnitkar, director and head of life sciences practices, Ernst & Young, Dr D Balasubramanian, director research, LV Prasad Eye Institute, Shyam Malhotra, editor-in-chief, Cyber Media publications, and Nitin Deshmukh, the director-general of the Association of Biotechnology-Led Enterprises (ABLE), debating on each of the nominees, while N Suresh, executive editor, BioSpectrum, lends the research support. In Mr Nitin Deshmukh, the director-general of the Association of Biotechnology-Led Enterprises (ABLE), BioSpectrum found another able ally. ABLE is the new voice of the biotech industry. As one of India's leading venture capitalist, Deshmukh has worked closely with the emerging industry for over a decade and continues to do so in his currently capacity. Editor-in-chief Mr Shyam Malhotra too was ready to transplant the experiences of his decade-long association with the DATAQUEST awards as one of its prime mover to the BioSpectrum Awards. And who better than Mr Abraham Mathew, chief editor of BioSpectrum, to make up the last slot on the jury to choose the first winners of BioSpectrum Awards. He has been the guiding force from the conception stage to the faultless execution of the awards project. The jury met in Dr Bala-subramanian's office in Hyderabad on 28th October. The BioSpectrum research team of Executive Editor N Suresh and Assistant Editor Srinivas Rao had prepared a sample set of guidelines and the background of all possible nominees. The BioSpectrum job ended there. For over three hours, the jury chairman Dr Balasubramanian brought the analytical abilities of other jury members in a way only he could have done as one of the leading teacher, researcher and administrator this segment has seen. There were intensive debates on each of the nominees for four of the five awards. For the remaining category, the Life Time Achievement Award, the jury did not take more than a minute to decide. As Dr Balasubramanian remarked during the meeting when the name was decided unanimously, " Prof. MS Swaminathan will actually be honoring this panel and the magazine if he accepts the award." Indeed he did, when the jury chairman personally met the Father of India's Green Revolution and conveyed the news. In the following pages, we present the achievements of three remarkable individuals, a state government led by a visionary political leader and his top notch team of bureaucrats and the burning desire of a team of academics who left security of their labs to create a world class software product that will be lapped by the biotech industry worldwide. N Suresh BioSpectrum Awards 2003 parameters Life Time Achievement 1. Path-breaking activities and contributions in the past 3-4 decades 2. Contribution to the evolution of the industry 3. Inspirer/influencer/visionary role Person of the Year A. Organization Role 1. Performance of the organization in the last 12 months 2. Major projects undertaken in 2003 3. Global initiatives B. Industry Building Role 1. Influence on the policy makers for the benefit of the industry 2. Fostering industry harmony and relationship building 3. Stature as a leader and visionary Entrepreneur of the Year 1. Strategic steps that make the company stand out in the crowd in the last two years 2. Imaginative business plan (should have innovative products and services) 3. Results achieved 4. Ability to raise funds 5. Ability to attract talent Product of the Year 1. Revenue consideration from the product 2. Uniqueness 3. Degree of difficulty in creating the product 4. Import substitution 5. Export potential 6. Price competitiveness State of the Year 1. Investments made by government 2. Attracted investments 3. Number of companies established 4. Hand-on involvement of CM 5. Exclusive biotech Secretary and advisors 6. Biotech park 7. Policy/Incentives provided 8. Revenue generation ]]> <![CDATA[BioSpectrum Awards 2003 - State of the year]]> https://biospectrumindia.com/news/95/1415/biospectrum-awards-2003-state-of-the-year.html https://biospectrumindia.com/news/95/1415/biospectrum-awards-2003-state-of-the-year.html Fri, 12 Dec 2003 12:10:00 +0530 State of the yearState of the year Andhra Pradesh The Biotech Building Block One of the most common grouse of entrepreneurs is that the governments are not doing enough to fuel their passion. This is a problem akin to all industries. Biotech is no different. But here is one state, which has made a difference. Be it small or big, new or old, states have begun the exercise to promote biotech. States are vying with each other for a share in attracting companies to their respective states. The reason: Andhra Pradesh has demonstrated that biotech can be groomed into a booming opportunity. A recent BioSpectrum-ABLE Top20 survey shows that the South has the largest share of business representation with about 39 percent hold in the Indian biotech industry. The total revenues generated by the South-based firms were Rs 899 crore. Out of this, business generated by companies in Karnataka was Rs 500 crore and that of Andhra Pradesh was in excess of Rs 200 crore. Though Karnataka may look bigger than Andhra Pradesh purely on this figure, the Biocon Group with total revenues of Rs 285 crore alone is the biggest contributor. It has over 55 percent of total contribution from the companies in Karnataka. Discount Biocon and it would be completely in favor of Andhra Pradesh. Many states would not agree in public that Andhra Pradesh is their role model. But the reality is that Andhra is leading the biotech revolution of the country by example. "The birth of a biotech cluster" reported The Financial Times (London) in its 14 August 2003 report on Andhra Pradesh. No doubt, it is the life sciences hotspot. It is a happening state. If not, why would Ranbaxy go to Andhra Pradesh? Several others like Astra Zeneca, Pfizer and Chemical Diversity, Genoexpression, Transzyme have agreed to start their biochemical R&D operations and contract research in ICICI Knowledge Park and SP Biotech park. Some of these deals are expected to be completed soon. More corporate than the corporates Andhra definitely has an unparalleled mindshare. Thanks to the efforts of the state government. The state government is the inducing factor. There is a corporate or business like approach. The team responsible for driving the initiatives may not be sitting in the most elegant of buildings like the modern corporates, but the team is much sharperâ€”in attitude, focus and decision making. The team defies the typecast bureaucratic image. It is much more approachable and responsive. As reporters we have experienced a much easier access vis-Ã -vis even some of the top named companies with great corporate governance. At the outset, one would not find these typical designated persons like chairman, CEO, and COO. But the team operates those responsibilities with ease. If permitted to map the organization tree of the government team, responsible for the biotech business of the state, it would read: Chief minister N Chandrababu Naidu as chairman; BP Acharya (secretary, industries and commerce department, Andhra Pradesh) as CEO; and D Nalini Mohan (additional secretary and director biotech) as the COO. Chief minister Chandrababu Naidu is a visionary. People like Dr Manju Sharma, secretary, DBT, feel that Chandrababu Naidu is great favorite of the scientific community and he prevails in decision making. Acharya and Mohan not only pair up very well, but also complement each other. While Acharya's strengths lie is thinking through, Mohan is a biologist himself. So it is not surprising to find Acharya and Mohan speaking business and biotech with ease. Added to that, the state government has a think tank. Dr Manju Sharma, secretary, DBT, Dr D Balasubramanian, head of research, LV Prasad Eye Institute, Dr MV Rao, former VC, Andhra Pradesh Agriculture University, Dr Lalji Singh, director, CCMB, Dr Syed Hasnain, director, Centre for DNA Fingerprinting and Diagnostics, S Dhawan, representative, Biotech Park Joint Venture Company and Utkarsh Palnitkar, consultant, Ernst & Young, are its members. They come from diverse fields and with varying expertise and lend a hand in shaping the biotech development in the state. It is this approach that the state of Andhra Pradesh follows that facilitates the development of the biotech business. Marketing model Success of any business is a conjunction of good products and effective marketing. Andhra Pradesh has the attitude of a business conglomerate. A quick analogy will show that the state government is the platform maker. The platform is the building block to build biotech industry. It is the "Intel Inside" for biotech. In fact the state has all the components that make it a quality platform. The state has a biotechnology policy, APIDC Venture Capital Ltd, a joint venture between the Andhra Pradesh Industrial Development Corporation and Dynam Venture East of USA, which has been providing venture capital to biotech start-ups. It has also an integrated IPR facilitating cell at ICICI Knowledge Park established is association with CII. This is to cater to the growing demands of the industries in Andhra Pradesh for patent search and analysis, patentability advisory services, IPR awareness and training. The list can stretch. The difference the state brings in business parlance is the early bird advantage. It has done all this before any other state. It is a strong marketing machine too. It understands the importance of brand building, selling, and customer care, not just facilitating the growth. Take for instance, Genome Valley. It is India's first state-of-the-art biotech cluster providing solid infrastructure to over 100 biotech companies. Keep aside the features like it is a natural cluster for biotech research, training, collaboration and manufacturing activities, spread over 600 sq. km. It would be more important to note here that the state has applied for the trademark. Steps like these demonstrate not only its smartness, but also its depth in understanding about how to build a brand. The state also realizes the importance of strategic alliances. For instance, it signed an agreement with Thailand to mutually promote biotech through collaboration in research and exchange of scientists and teaching professionals. This alliance would be beneficial in the area of marine biotechnology and biotech applications for aquaculture and tropical medicine. The agreement with Iowa State of USA is to leverage agribiotech and bio-medical research. Take another case, it tied up with Research Triangle Park of North Carolina in February 2002. Because of this equation, companies like CiVentiChem, a contract research and drug-discovery support company, and Kard Scientific Inc. of Cambridge, USA have set shop in Genome Valley. There are hardly a handful of states seeing the importance of strategic alliances. Another thing the state is doing is facilitating networking. It has decided on two featuresâ€”Biotec International, a show to be held once in two years, and BioAsia an annual premier event. The first version of BioAsia is scheduled for February 2004. Acharya said, "The series of events will enable the industry to have a platform to understand the issues and deliberate and also showcase each other's strengths." Such conferences have proved to serve as an excellent "industry-academia-global" networking platform. What's next? What most companies admire about the state is its initiative in setting up APIDC Venture Capital Ltd. Its "Biotechnology Venture Fund" is India's first national fund focused on biotechnology companies. It has already funded to a tune of Rs 8.1 crore in three companies and targets a Rs 150 crore corpus. While most states are still talking about wooing investors and trying to build infrastructure or drafting biotech policies, Andhra has already begun to think on the next step forward. How to make Andhra a global vaccines supplier? How to attract a few world leaders in the biotech sector to set shop in the parks? Set up an animal research and testing center. Start the International Institute of Life Sciences. All these, to take form, may take time. Nevertheless, it is the pioneer of a model that today others can replicate. That is why industry leader Kiran Mazumdar-Shaw does not hesitate in saying "The combination of Karnataka's entrepreneurship and Andhra government's vision, strategic direction, and support give India a very strong profile." Ch. Srinivas Rao "We are setting up standards with world class infrastructure and a long term policy for making AP the #1 destination for investments from all over the world." Interested in knowing what is happening in Andhra Pradesh! BioSpectrum could have written on the biotech activity in the state. But we decided that this information, if it comes from the horse's mouth, will be even more interesting to read. We sent a detailed questionnaire to Chief Minister N Chandrababu Naidu and he responded to the same. Here is what Naidu has to say on the state's biotech activities, initiatives, plans and vision. What is your vision for Andhra Pradesh with reference to the biotech/life sciences sector? My vision for Andhra Pradesh with reference to biotech and life sciences sector is that a common man should get the benefits of new technologies emerging in these fields. My vision is to provide a disease-free and healthy society by using modern technologies and we are working towards that. For instance, we are establishing International Institute of Life Sciences in Hyderabad, involving the leading biotech and life sciences industries in the State. We are developing centers-of-excellence in different branches of biotechnology viz. for agri and veterinary biotechnology in Acharya NG Ranga University, an agribiotech incubator in ICRISAT, a marine resource development center in association with Andhra Pradesh University and a pharma biotech hub in SP Biotech Park and ICICI Knowledge Park in Genome Valley near Hyderabad. Through such initiatives, we envision developing the state of AP into a biotechnology state of the country. When and how did Andhra Pradesh embark on attracting investments in biotechnology? Andhra Pradesh has a very strong pharmaceutical industry. It is the bulk drug capital of the country. So when the Government of Andhra Pradesh started to emphasize on biotechnology, several industry leaders started looking towards Andhra Pradesh and Hyderabad in particular. The state has been attracting investments in biotechnology for the last seven to eight years and the investments have picked up in the last couple of years. What are the short term and long term strategies to make AP a leader in biotechnology? Andhra Pradesh is the first state in the country to have an exclusive policy for biotechnology in the year 2001. We have announced the policy framework and clear strategies have been worked out. The short term strategies are projecting the strengths of the state, especially the locational advantage of Hyderabad, the strong presence of world class research institutes like CCMB, CDFD and IICT, the availability of a strong pool of trained and scientific manpower, the recently developed ICICI Knowledge Park and SP Biotech Park and a proactive and environment friendly Government Policy. Among the other strategies to make AP a leader in biotechnology, we have created a brand name called "Genome Valley" and it is widely popular all over the world. We are setting up standards with world class infrastructure and a long term policy for making AP the #1 destination for investments from all over the world. We have created an enabling environment for establishing the biotech industry. We have a single window clearance system for hassle free licensing and approvals. We participate in the international and national exhibitions, conferences and demonstrate our strengths and invite foreign participation and collaboration into Andhra Pradesh. We are liberalizing the labor laws to match the requirements of the industry. Has the State Government identified specific sectors to leverage the existing strengths in AP and leapfrog in biotech? The AP government has been encouraging pharma and biotech sectors to leverage the existing strengths in AP. Vaccines and recombinant DNA products in health care, nutraceuticals and medicinal plant formulations are some of the areas that have been identified as key sectors for growth and long-term development. This apart, contract research and clinical trials also have good promise. The APIDC-VCL is a path-breaking initiative by AP to provide the much needed "seed funds" for biotech entrepreneurs. Will the corpus be increased if the demand from entrepreneurs increases tremendously? APIDC-VCL is the first of its kind in the country. Government of Andhra Pradesh has analyzed that the most crucial input in starting a new venture is the VC funding. In order to kick start the biotech industry, especially startups, the APIDC-VCL endeavor is vital. The corpus is swelling every day and as of now it is targeted to mop up about Rs 150 crore. Apart from the AP government, Andhra Bank, LIC, GIC, PNB and others are participating in this VC Fund. What are the Government's plans to provide the latest infrastructure and incubator facilities to biotech entrepreneurs? The Government of Andhra Pradesh has special plans to provide the latest infrastructure in the form of uninterrupted water and electricity supplies to the Biotech and Knowledge Parks. A dedicated sub-station has been erected in the Genome Valley for uninterrupted electricity. Fast track roads have been laid connecting the Genome Valley to other parts of the city. India's first biotech incubator is being established in SP Biotech Park in Genome Valley with an outlay of Rs 22.50 crore in association with DBT and IICT. The incubator offers the latest state-of-the-art facilities for start-up and existing biotech companies and entrepreneurs to try out their new technologies and processes which otherwise would become very difficult to do. The Government is investing huge amounts on all the infrastructure. A National Animal Resource Testing facility is also planned in association with ICMR and National Institutes of Health and an area of 100 acres has been earmarked for this purpose in Genome Valley. An agribiotech incubator is coming up in ICRISAT exclusively for developing new technologies for sustainable agriculture. It will facilitate in producing new crops and varieties for food security and for increasing the nutritional value. What are the fiscal and other incentives available to potential biotech entrepreneurs in AP? There are a number of incentives available to potential entrepreneurs in Andhra Pradesh. There is 25 percent capital subsidy in the cost of the land for the biotech parks, and a rebate in the land cost at the rate of Rs 30,000 for every job created in bioinformatics and other related fields in the parks and a concessional sales tax of only 1 percent as against 12-14 percent outside the park areas. The other incentives available to potential biotech entrepreneurs in AP include provision of water supply and power supply up to the doorstep and excellent roads. A residential accommodation proposal for the personnel working in Genome Valley at concessional rate has also been initiated recently. The government has created an IPR facilitation cell for helping companies in their patenting and other aspects as well as a virtual library and documentation center in ICICI Knowledge Park. Many states seem to be competing with each other to attract biotech entrepreneurs? Is such competition desirable and healthy? In a growing economy, competition is unavoidable. Irrespective of where the investment comes from, India is developing and marching ahead in the field of biotechnology. But the investors will always look for the best state on "good governance" and if healthy competition exists, it will boost the industrial growth and help the country ultimately. Which are the most promising startups and technologies emerging in the state? There are many startups and technologies in biotechnology. Matrix Laboratories, GVK Bio-Sciences, Bio-Serve Biotechnologies, Krebs Biochemicals, Indigene Pharma, etc. are a few start-ups with their new technologies and international partners located in the Knowledge Park. The Biotech Park has companies like Genotex, KCP Biotech, Ocimum, Jasmine, Aktiva Biotech and Sandor. These are all startups with good promise. Many companies have anti-cancer and anti-AIDS technologies and products like diagnostic kits are being proposed to be manufactured in Hyderabad. Will you push for a National Biotechnology Policy and a National Biotech Venture Fund to give fillip to this sector? A biotechnology VC Fund at national level is a necessity for India. We will also strive to get a National Biotechnology Policy. High quality education is a key factor in biotech. AP has a number of top quality education centers. Any plans to supplement these efforts to cater to the future needs? We are at present strengthening the existing training and educational institutions in the state. We are planning to set up one Marine Bioresources Development Center in Visakhapatnam. While an agribiotech incubator is coming up in ICRISAT campus, National Animal Resource Testing facility is being set up in collaboration with ICMR/NIH at Genome Valley. Are there any plans to ensure that the private sector educational institutions adhere to certain minimum standards? We have an active private sector in the state. We encourage public-private and private sector participation models in biotech education and industry. Quality standards are maintained in education and training. Genome Valley is emerging as a quality standard certification agency for biotech in the state. Do you have any specific projects to ensure that some of the benefits of modern biotechnology address the larger social and health issues confronting people in tackling diseases like typhoid, cholera and malaria? Our Government is committed to health for all. Health is identified as one of the important thrust areas. Immunization programme is very successful in the state. We are marching towards vaccines for cholera, typhoid and other communicable diseases. Hyderabad is emerging as the vaccines' capital of the country. We have leading developers and manufacturers like Biological E, Bharat Biotech and Shantha Biotech here. What would you like Andhra Pradesh to be related withâ€”meaning what should the recall value of the State be? I want AP to be #1 in biotech. That is our goal. I think we are marching ahead. Who are the members of your biotech team? And to whom should the credit go in making biotech successful in AP? Government is proactive and responsive. It is a team effort.   ]]> <![CDATA[BioSpectrum Awards 2003 - Entrepreneur of the year]]> https://biospectrumindia.com/news/95/2400/biospectrum-awards-2003-entrepreneur-of-the-year.html https://biospectrumindia.com/news/95/2400/biospectrum-awards-2003-entrepreneur-of-the-year.html Fri, 12 Dec 2003 11:25:00 +0530 Entrepreneur of the year Krishna M Ella    Scientist-turned-entrepreneur During the past few months, Dr Krishna M Ella, chairman and managing director, Bharat Biotech India Ltd (BBIL) has been having sleepless nights. Not because he is the center of any controversy, but because he has been busy with several initiatives. Towards the last week of September, Ella was busy readying Indikinase, a recombinant streptokinase (a first-line therapy for myocardial infarction) for launch in the market place. Besides, he was preparing to hand over the first batch of Haemophilus Influenzae B (HIB) conjugate vaccine to Wyeth Lederle. Mid-October, he was busy managing the visit of South African President, Thabo Mbeki, to BBIL's manufacturing facility in Genome Valley (Thurkapally). During November, he was busy with the team from Indo-US Vaccine Action Program (VAP) reviewing the progress of the rotavirus vaccine. The proposed vaccine will protect children against the scourge of rotaviral diarrhoea. Interpretation of these events will give a better insight in the persona of Dr Ella. BBIL, which had a major contract for manufacturing HIB conjugate vaccine from Wyeth Lederle, dispatched the first batch of vaccine, constituting 0.5 million doses, to Dr VB Sovani, director, Wyeth Lederle, during the Biotec India International 2003 show in Hyderabad. This is seen as a major achievement for Bharat Biotech as Wyeth has for the first time looked to manufacture HIB vaccines outside the US. Further Indikinase launch in October made BBIL among the first few in the world to manufacture recombinant streptokinase. The visit of South African President Thabo Mbeki was leveraged not only to showcase BBIL's strength, but also as an occasion to spread its reach beyond the Indian shores. Ella and Tokyo Serewale, executive chairman, Mvelaphanda Holdings of South Africa, the world's second largest gold and diamond company, signed an agreement. This is to replicate BBIL's facility and take the technology developed by it to South Africa. A joint venture for the same would be floated. The third development was to review the progress of the development of the vaccine at about a hundredth of the cost of the average MNC. FACT FILE OF Dr Kirshna M Ella Position: Chairman and managing director, Bharat Biotech International Ltd Age: 40+ years Academics: Did his BS and MS from Nagpur and Bangalore with distinction and honours. Doctorate from the University of Wisconsin-Madison, in molecular biology (1992) Family: He is married to Suchitra Ella, who is the founder director of Bharat Biotech. The couple has a son and a daughter. Entrepreneurship: Started Bharat Biotech in 1996 Other hats: Member of the CII national committee on IPR (2003-04). Other professional honours include: member, FICCI Pharmaceutical and biotechnology committee; member (2002), working group of science & technology, Planning Commission (2001); member, Vaccine Board, Government of India (2000), member, Pharma Task Force (2000), AP government (2000), member, National Health Mission, headed by Dr APJ Abdul Kalam (2000), among other. Since fall 1993, he has mentored two graduate students and two postdoctoral fellows Awards & Accolades: Dr KC Chatterjee Memorial Award from the Indian Pharmaceutical Association (1999) BBIL MILES Established in 1996. Launching and Commercial production of Revac B (World's first cesium chloride free Hepatitis B vaccine) In 1998. Marketing of Revac B in 1999. Launched typhoid vaccine, Typebar, in May 2003. Launched Indikinase in October 2003. Contract manufacture a vaccineâ€”HibTITER for Wyeth Lederle Ltd in September 2003   All these show the aggressive entrepreneurship of Krishna M Ella. His mission is empowered by the Indian President Dr APJ Abdul Kalam's, three-vaccine dream for the countryâ€”hepatitis B, malaria and HIV. "It is his dream that is fuelling our efforts and leading us closer to realizing the goal of bringing affordable, world-class healthcare to the needy in our country," stated Ella. "My current challenges include getting out of biogenerics mode and concentrating on new molecule development. The next thing is to become a global player. Bringing affordable vaccine to rural population of India and gearing up my company to face post-2005 scenario." He is synchronizing the product development and marketing very well. Of course, nothing comes risk-free It is neither mission impossible nor mission accomplished yet for Ella. He recounted, "After staying 15 years in the US, it was not easy for us (Dr Ella and his wife Suchitra) to relocate to India. It was a tough decision to make. But we both wanted to come back. The decision seemed risky. But then as a graduate student in Madison, Wisconsin, we were taught to take risks. I decided to become a bioentre-preneur. We brought together like-minded professionals from the US. Sold personal assets in the US to make this dream come true. There were so many challenges we had to face. "For the first time, I proposed to produce the hepatitis B vaccine for one dollar in 1994. None of the financial institutions in India were prepared to believe this. But perseverance pays. Bharat produced the world's first cesium free hepatitis B vaccine at an affordable price for the common man. Today, UNICEF buys Bharat's hepatitis B vaccine for 23 cents( Rs 10) per dose. I think that the real challenge for a scientist is not only develop a product but also envisage its pricing." In the early 1990s, when the first hepatitis B vaccine was introduced in the country by SmithKline Beecham, it was prices at Rs 1400 per dose. What is very embellishing about Ella is his capability as a scientist and as an entrepreneur. Born in Tiruthani, near Chennai, Ella has been a very good scientist. He acquired his doctorate from the University of Wisconsin-Madison in molecular biology in 1992 and spent more than a decade conducting independent research and teaching in renowned universities in the US. He is well versed in plant, human and animal systems. Before embarking BBIL in 1996, he served as a professor (research) with Medical University of South Carolina (1993-96). He started his career as a research fellow with Indian Council of Agricultural Research, then joined Sandoz (I) Ltd as technical representative, moved to Bayer as technical officer, went to University of Wisconsin as research assistant among other things, before joining the South Carolina Medical University. Does being a bioentrepreneur come easy? No guesses on that. The matter of fact is that he is a first-generation entrepreneur and braved many a challenge. Ella explained, "The concept of bioentre-preneurship is still new in India. There is no easy path and we have to create one for ourselves. This is the industry's biggest challenge. Scientists in our country follow the road lined with obvious well-defined rules and symbols. While the need for academic excellence is understandable, the world out there is waiting for safe, affordable, healthcare solutions that can affect millions of lives. It is biotechnology that can come up with answers. I think we have found the right balance at Bharat. We have adopted a business model that ensures that scientific and business perspectives are given due place equally." Year 2003, a new chapter in Ella's life For Ella, a classic case of successful scientist-turned entrepreneur, the year 2003 has been an eventful one. There were just two products from its stable till May in 2003â€”Revacâ€“B, the recombinant vaccine for hepatitis-B in 1998, and Biogit, claimed to be India's first indigenous probiotic yeast. BBIL launched its typhoid vaccine, Tybar, in May 2003. Then in September end, he launched streptokinase. While the market for the typhoid vaccine in India is estimated at around Rs 60 crore, the market for streptokinase is estimated at around Rs 80 crore in the country. This heralds the beginning of the consolidation of his dream sojourn in biotech. Though, the turnover during 2002-03 was about Rs 20 crore, Ella sees 2003-04 as a year of turnaround. He expects to see the topline to grow to Rs 60-80 crore. He has also set his eyes now on the insulin market, estimated to be worth Rs 250 crore. If all his projects come through, which Ella is confident of, by 2010 BBIL could touch the Rs 1,000 crore mark. He has a penchant for attracting investments and people. He has already attracted investments to the tune of Rs 125 crore. Said Ella, "We have invested more than Rs 100 crore in developing a world class manufacturing facility at Genome Valley in Hyderabad for manufacturing vaccines, biothera-peutics, and biopharmaceuticals. We raised the funds through internal accruals, State Bank of India and IDBI (Industrial Development Board of India), ICICI, and Technology Development Board of India. BBIL is the first Indian company to get two grants from the Bill & Melinda Gates Foundation's Program for appropriate technologies for healthâ€”for children's vaccine program and malaria vaccine initiative." Further, Ella has been able to work smoothly with the Indian institutions. This has been a major resource for BBIL's R&D work. Not just Indian institutes, but Ella has been able to forge ties with international institutes of repute like Center for Disease Control-Atlanta, USA, National Institute of Health-Washington DC, National Child Health Institute, National Institute of Allergy & Infectious Diseases (US-Govt.), University of Wisconsin-Madison, Stanford University, and International Vaccine Institute, Seoul, to name a few. These collaborations have paved the way for not only getting grants but also coming up with new products in relatively quick time and in a cost-effective mode. As a result of all this, BBIL has eight patents granted. The most significant one is a global patent for a biotech molecule, Lysostaphin, which targets staphylococcus infection. That characterizes Ella's approachâ€”think big. His formula has been better technology management and process innovation as the differentiation. The modus operandi he followed was a mix of collaborative research and funding from international and national bodies to minimize risks, coupled with huge volumes to roll out products. He draws his inspiration from the likes of Dr RA Mashelkar, DG CSIR, Indian President, Dr APJ Abdul Kalam, Dr G Padmanabhan, former director of Indian Institute of Science, Bangalore, Dr Roger Glass, CDC Atlanta, and Prof. Harry Greenburg, Standford University. He admires Dr Anji Reddy for his passion for science. Hence, it is not surprising thatr Ella has an easy nature, is approachable, and has all the warmth. He is not averse to meeting people and goes about sharing his ambition of realizing the goal of bringing affordable, world-class quality health care to the needy in our country with his team members. He is articulate too and his speeches are by the spur of the moment. All these qualities make him a very good technopreneur. Ch. Srinivas Rao "We are in forefront of life-saving What is the current mission and vision of your company? We at Bharat envision a disease-free future. It is our cherished vision to offer affordable, safe and effective healthcare solutions to combat mankind's most dreaded illnesses and to thus eradicate or at least control their occurrence in the years to come. The corporate vision of Bharat is to ensure a healthy tomorrow. At the heart of all our efforts is the undaunted and ceaseless aspiration to develop and provide next-generation remedies through extensive research in genetic engineering and rDNA technology and to focus on augmenting national self-reliance in the sphere of affordable health care. We also would like to become a global player in the biotechnology sector. What are the key achievements so far? BBIL has notched up a lot of firsts to its credit. We have the largest biotech facility in Asia-Pacific with over 3 lakh sq ft of clean room facility conforming to cGMP/USFDA/UKMCA. The first biotech plant in Asia with P2 and P3 production containment facilities. We were the first to produce world's first cesium free hepatitis-B vaccine. We have a global patent for a new biotech moleculeâ€”Lysostaphin to fight staph infection. Bharat is India's first and world's second manufacturer of Indikinase (obtained US-patent on the technology). We are the largest primary manufacturer of typhoid vaccine. We are the first Indian biotech company to manufacture HibTITER vaccine for Wyeth Lederle, USA. The first Indian company to be assigned the responsibility of developing two new vaccinesâ€”rotavirus and malaria. First Indian company to get two grants from the Bill & Melinda Gates Foundation's Program for Appropriate Technologies for Health. Bharat has also obtained five research grants from DST. What has been the total investment in the company? We have invested more than Rs 100 crore in developing a world-class manufacturing facility at Genome Valley in Hyderabad. We raised the funds through internal accruals, SBI and Industrial Development Board of India (IDBI), ICICI and Technology Development Board (TDB) of Indian government. What are the research activities going on at Bharat? We are in the forefront of technology development. Bharat has come a long way after launching its flagship product, Revac-B, on 22 October 1998. The company has developed vaccines for infectious diseases pertinent to developing countries such as Typhoid. We are now actively involved in developing vaccines for rotavirus and malaria. Vaccines for Rabies and Japanese Encephalitis from Bharat have entered clinical trials. We are also in the forefront of developing critical life-saving drugs and biopharmaceuticals. How have the products developed by Indian companies progressed? Indian biotechnology sector is progressing at a steady pace. I would say, we are on par with Korea and Cuba. But Indian companies need to focus on exports. The present trends suggest that more and more pharma companies are diversifying into the biotech sector. It would be wise to have synergy between the pharma and biotech companies to avoid cannibalization of effective products. The pharma industry should not lose focus at the market place. With the development of the domestic market, both availability and pricing have become competitive. This has resulted in a tangible advantage to the consumer. Export is another arena, which needs a lot of focus. Consistency, quality and competitive pricing can result in volumes and result in capturing new markets. Exports of bioproducts still have to pick up. What is the issue? The exports of Indian bioproducts are not picking up as expected due to two main factors. The first is the mindset in the global market regarding quality of our products, which needs to be addressed immediately. The second is the pricing. Increasing awareness about Indian bioproducts can go a long way in demystifying these issues. How many manufacturing plants do you have now and how do you plan to gear them to address new products? The company has over 3 lakh sq ft clean room facility conforming to cGMP protocols for production of vaccines, biotherapeutics and biopharm-aceutical products as stipulated by WHO, USFDA and UKMCA. BBIL's state-of-the-art biological facility is the largest in its genre in the Asia Pacific region. BBIL has two large manufacturing facilities: a dedicated facility for hepatitis-B, the second largest in the world, with a capacity of 100 million doses per annum and the largest multi-product manufacturing facility consisting of biotech incubator, contract manufacturing and filling facility. The first of its kind in the world, this facility can be utilized for contract manufacturing/formulations. Strategic alliances are important in any venture â€¦ We view strategic alliances as key drivers for overall development and for augmenting the pace of growth. At Bharat we have adopted a "collaborative research model". We work in consonance with the world's best known research institutions such as CDC Atlanta and Stanford University. What is the message for the biotech industry and the policy makers and industry? Biotechnology is skill-oriented and capital intensive. Companies in this sector should come together and cooperate instead of mindlessly competing with each other. The regulatory framework also needs to be reviewed. A single window comprising of DCGI, GEAC and DBT would greatly speed up the process. This would also help monitor a product from the beginning to the end. An advisory committee could help in making judicious decision relating to biotech products. Dr Mashelkar pioneered the IPR concept in this country. We need someone to champion the regulatory reforms. The message is to keep the good work going. Consistency in our efforts will help us tide over the challenges posed by the patent regime. The need of the hour is to create awareness. The government along with the industry must pool in their efforts to increase responsiveness in the public towards biotech products. The efforts of the global biotechnology community are setting an example. Much of the efforts today are focused on treating, detecting and preventing human disease. With new-found information such as mapping of several genomes, novel therapeutic and diagnostic breakthroughs are emerging.   ]]> <![CDATA[Lilly, Applied Molecular announce merger]]> https://biospectrumindia.com/news/95/2287/lilly-applied-molecular-announce-merger.html https://biospectrumindia.com/news/95/2287/lilly-applied-molecular-announce-merger.html Thu, 11 Dec 2003 19:08:00 +0530 LillyLilly, Applied Molecular announce merger Steven M Paul, MD, executive vice president, science and technology for Lil Eli Lilly and Company and Applied Molecular Evolution Inc. have mutually agreed to AME's merger into Lilly. The boards of directors of Lilly and AME have given their approval to the transaction, which is subject to approval of AME shareholders, clearance under the Hart-Scott-Rodino Anti-Trust Improvements Act and certain other closing conditions. "We believe that the combination of Lilly's therapeutic area discovery and medical expertise and AME's industry-leading protein optimization technology will enhance our stature as a world leader in biotechnology products," said Steven M Paul, MD, executive vice president, science and technology for Lilly. "Lilly is an ideal strategic fit for AME. Our combination with Lilly will leverage the protein therapeutic optimization and development capabilities that we have created and provides a very substantial return over the past year to our shareholders," said William D Huse, MD, chief executive officer and chairman for AME. AME, located in San Diego, will retain its name but become a wholly owned subsidiary of Lilly and integrate with Lilly's research organization. Under the terms of the agreement, AME shareholders will receive $18 for each outstanding AME share at closing. AME shareholders may elect to receive the $18 in cash or shares of Lilly common stock based on the closing price of Lilly stock on the closing date, subject to proration such that the total purchase price paid by Lilly is 80 percent stock and 20 percent cash. The value of the transaction as of the anticipated closing date is expected to be approximately $400 million, net of cash. The transaction is expected to close in the first quarter of 2004. AME is a leader in applying directed molecular evolution to improve healthcare by optimizing and developing human biotherapeutics. Peptor, Develogen intend to merge Guenther Karmann, CEO, DeveloGen AG Peptor Ltd., a biopharmaceutical company engaged in discovery and development of immunotherapeutic drugs to treat diabetes and other autoimmune diseases, and DeveloGen AG, a biology-driven drug discovery company developing novel therapies for diabetes and obesity, announced that the boards of both companies agreed on terms to merge their businesses. In this merger of equals, the shareholders will receive a share for share offer. The merged company will have its headquarters in Germany and will be known as DeveloGen AG. The company will keep the R&D operation of Peptor in Israel and maintain the professional team for future preclinical and clinical development. In conjunction, the companies announced a third round of financing. The investment is led by Techno Venture Management (TVM) and includes investors such as Nomura, DVC Deutsche Venture Capital, Global Life Science Ventures and Dansk Kapital Anlaeg. Guenther Karmann, CEO of the merged company, commented: "This is a marriage of two highly complementary sets of assets and skills. Peptor's diabetes focussed clinical pipeline is perfectly complemented by an innovative and productive discovery machine focused on metabolic disease. This gives us an advanced and sustainable flow of clinical candidates. Further, combining clinical expertise with world leading biological understanding of the mechanisms underlying metabolic diseases makes the combination a powerhouse of intellectual capital." Helmut Schuehsler, managing partner of TVM, added: "Companies with sustainable clinical pipelines, world leading science and a clear disease focus which are supported by strong management will be the best IPO candidates. With this merger, we are building such a company which will be one of the leaders among private biotechnology companies in Europe." Biotech raises more cash in 2003 According to Ernst & Young biotech companies worldwide have raised some $11.9 billion in the first nine months of the year. Major part of it has been in the US, already exceeding the $10.5 billion in the whole of last year. Since September, seven US companies went public, raising around $500 million. Venture capital funding in Europe however was down by half with investors wary of investing in the sector. The IPOs in Europe could open by mid-2004 in Europe. Globally, about 17 biotech drugs have got the nod from the US Food and Drug Administration by July, compared to 20 the whole of last year. Genome Therapeutics, Genesoft in definitive merger agreement Genome Therapeutics and Genesoft Pharmaceuticals, a privately-held pharmaceutical company, have entered into a definitive agreement to merge in an all-stock transaction. Pending successful completion of the merger, Genome Therapeutics and Genesoft will become a leading, integrated biopharmaceutical company focused on the commercialization and development of new anti-infective therapeutics. The merged company will focus on the 2004 launch of FACTIVE (gemifloxacin mesylate tablets), which received FDA approval for two indications this year, the Ramoplanin clinical development program and the maturation of the companies' earlier stage assets. The combined company will be known as Genome Therapeutics. Steven M Rauscher, chairman and CEO of Genome Therapeutics, who will serve as president and CEO of the new company, stated, "Merging with Genesoft is a transforming event for our company, as we will immediately realize our goal of becoming a biopharmaceutical company with a high-profile product and a complementary near-term product candidate in late-stage clinical trials. Initially, we will be focusing our efforts on ensuring the successful launch of FACTIVE to coincide with next year's respiratory tract infections season, thus positioning the company as a key participant in the commercialization of anti-infective therapeutics." The board of directors at both the organizations has unanimously approved the merger agreement. As per it, Genome Therapeutics will issue approximately 28 million shares of Genome Therapeutics common stock to the existing security holders of Genesoft, and assume debt of $24 million. The transaction is expected to qualify as a "tax-free" reorganization for federal income tax purposes. Xenova offers to raise £21.1 million Xenova Group PLC, the UK-based bio-pharmaceutical group, which focuses on the therapeutic areas of cancer and immune system disorders, announced that it proposes to raise approximately £21.1million through a UK Placing, a US Private Placement and an Open Offer of 18,760,169 units, comprising an aggregate of 187,601,690 offer shares and 56,280,507 warrants, at a price of 112.5p per unit (each unit comprising 10 offer shares and 3 warrants), and to reorganize its share capital. David Oxlade, chief executive officer of Xenova commented: "We are delighted with the strong support received from both existing and new shareholders and are particularly pleased to see a significant participation by US investors in the issue. Xenova has a broad pipeline of products in clinical development and partnerships with a number of significant pharmaceutical companies. With these funds, we now have the required capital to fund the first phase III trial of TransMID and to progress the development of the company's later stage programmes." Lorantis gets $42 million in new financing led by Apax Partners Dr Mark Bodmer, CEO of Lorantis Lorantis, an immunology drug discovery and development company, announced the closing of a £25 ($42) million series C private financing round led by Funds advised by Apax Partners. Apax Partners Funds were joined in this financing round by existing investors Abingworth Management, JP Morgan Partners, Quester Capital Management, Schroder Ventures, The Wellcome Trust and funds managed by Fleming Family and Partners. "The closing of this financing round is a significant milestone for Lorantis. It gives Lorantis the substantial resources we need to move our products into clinical development and establish the key clinical milestones, which will underpin the future value of the company. We are delighted that such a high quality group of life sciences investors recognize the enormous opportunity that Lorantis offers," said Dr Mark Bodmer, CEO of Lorantis. Lorantis has discovered a fundamental immune mechanism, by which the immune response to any disease-causing antigen may be suppressed while the vital normal function of the immune system as a whole is preserved. The company is developing a pipeline of protein and DNA therapeutics for the treatment of immune disorders using its proprietary Antigen-Specific Therapy (ASPECT) platforms. This new class of targeted medicines has the potential to transform the treatment of a broad range of major immunological disorders, including allergy, autoimmune disease and transplant rejection. Adolor Corp. announces closing of equity offering Adolor Corporation announced that it has completed the sale of 6,900,000 shares of common stock at a public offering of $17.25 per share. This amount includes the exercise of the underwriters' option to purchase 900,000 shares to cover over-allotment. The gross proceeds from the offering were approximately $119 million. Adolor is a biopharmaceutical company specializing in the discovery, development and commercialization of prescription pain management products. Entereg (alvimopan), Adolor's lead product candidate, is being developed to manage postoperative ileus, the gastrointestinal side effect which can affect millions of patients following many types of surgery. Adolor's next product candidate is a sterile lidocaine patch in clinical development for treating postoperative incisional pain. Adolor also has a number of discovery research programs focused on the identification of novel compounds for the treatment of pain. Keryx raises $15 million in private equity transaction Keryx Biopharmaceuticals Inc., a biopharmaceutical company focused on the acquisition, development and commercialization of novel pharmaceutical products for the treatment of life-threatening diseases, including diabetes and cancer, announced that it has entered into definitive agreements with several institutional investors relating to a private placement of approximately $15 million in gross proceeds through the issuance of common stock and warrants. Michael S Weiss, chairman and CEO, Keryx, stated, "We are very pleased to have consummated this financing with some of the highest-quality investors in the biotechnology sector. We believe that this serves as strong validation of the promise of KRX-101 and the company. Following this offering, we will have approximately $34 million in cash and cash equivalents, which should carry us well into 2006. The additional funds will not only provide us with capital to support our current and planned clinical programs for KRX-101, but also with added flexibility in our in-licensing and product acquisition program as we aim to build out our pipeline with additional clinical-stage drug candidates." Keryx sold a total of approximately 3.5 million shares in the transaction at $4.25 per share. It is developing KRX-101 (sulodexide), a novel first-in-class oral heparinoid compound, for the treatment of diabetic nephropathy, for which Keryx is currently conducting its US-based Phase II/III clinical program. Keryx also has an active in-licensing program designed to identify and acquire clinical-stage drug candidates. Additionally, Keryx is seeking partners for its KinAce drug discovery technology and related products. Washington University launches a $300 million biomedical program Chancellor Mark S Wrighton, Washington University Washington University and its School of Medicine announced they will spend more than $300 million to rapidly bring the new knowledge of the human genetic blueprint to the patient's bedside and to change how illnesses ranging from diabetes to Alzheimer's disease to various cancers are understood, diagnosed and successfully treated. This new strategic research initiative is called BioMed 21, a reference to its potential to redefine how biomedical research will be conducted and medicine will be practiced as the 21st century unfolds. The program will include faculty from the University's Schools of Medicine, Engineering and Arts and Sciences. A positive step toward making St. Louis a biotech powerhouse, BioMed 21 will be supported through gifts, federal research grants and internal resources. The announcement was made by Chancellor Mark S Wrighton and by Larry J Shapiro, MD, dean of the School of Medicine and executive vice chancellor for medical affairs. They said more than $200 million in endowment, construction and programmatic funding had already been committed in support of BioMed 21. As part of BioMed 21's unveiling, the University announced that the School of Medicine's Genome Sequencing Center, under the direction of Richard K Wilson, PhD, will receive new funding totaling more than $130 million over three years from the federal government's National Human Genome Research Institute (NHGRI). The funding is part of the next generation of national, large-scale gene-sequencing projects, designed to decipher the genetic code of nonhuman species and, through comparison with the human genome, shed light on the complex interactions between genes that regulate normal or disease processes in humans, as well as the origins of the diverse forms of life that inhabit our planet. Introgen to raise $20 million Introgen Therapeutics announced an offering of approximately 2.86 million shares of its common stock at $7 per share. Subject to customary closing conditions, Introgen will receive gross proceeds of approximately $20 million. SG Cowen Securities Corporation acted as managing placement agent for the offering. Introgen anticipates using the net proceeds from the offering primarily for working capital purposes and other general corporate purposes, including the development of Advexin and INGN 241, Introgen's anti-cancer product candidates which are in phase 3 and 2 clinical trials, respectively. According to Tom Finnegan, Introgen's vice president of finance and corporate development, the additional resources will strengthen company's balance sheet at a time when it is discussing marketing partnerships for Advexin therapy, preparing to file a Biologics License Application for Advexin with the FDA, and advancing the development of anti-cancer products. Introgen's Advexin therapy is designed to induce therapeutic protein expression using non- integrating gene agents for the treatment of cancer and other diseases. Alchemia launches $21 million IPO Alchemia announced it has lodged a prospectus with the Australian Securities and Investments Commission for a $21 million public offering and to seek a listing on the Australian Stock Exchange. Alchemia is an Australian biotechnology company dedicated to the development of new therapeutics and specialty pharmaceuticals, using a unique proprietary carbohydrate-based technology. Under the Offer, Alchemia will issue 30.0 million new shares at an issue price of $0.70 each to raise $21 million, bringing the total shares on issue to 100 million. Upon completion of the Offer and subsequent listing on the ASX, Alchemia is expected to have a market capitalization of approximately $70 million. Alchemia's chairman, Mel Bridges said, "Alchemia has developed and applied to patent a process for the manufacture of a generic form of Arixtra, a synthetic heparin, used to prevent the formation of blood clots. The heparin family of anticoagulants, including synthetic heparin, had sales exceeding $3 billion in 2002. Intercell AG closes financing round at $50 million Alexander von Gabain, PhD, CEO, Intercell AG Intercell AG, a privately-held Austrian-based vaccine company, announced the second closing of a Round "C" private venture financing, which raised a total of $50 million. Global Life Science Ventures led the initial closing in July 2003 and MPM Capital (US) invested in a second closing on November 20. The total raise of $50 million constitutes the largest biotechnology private equity financing to be completed in Europe in the last 24 months. Intercell AG has now become Europe's first biotech company to achieve a total of $100 million in private funds. Luke Evnin, general partner of MPM Capital, noted: "We view Intercell as an exciting company that reflects all the key attributes for success, including broadly-applicable technology, experienced management, a full pipeline of product development candidates that meet significant unmet medical needs, and a well-planned business strategy." Alexander von Gabain, PhD, CEO, Intercell AG, stated "Intercell is a product-driven company, and this financing will be directed to accelerating the clinical development of our lead products: a therapeutic hepatitis C vaccine and a vaccine against Japanese encephalitis. Both products will enter Phase III clinical trials in 2004."     ]]> <![CDATA[All statins are not alike]]> https://biospectrumindia.com/news/95/2487/all-statins-are-not-alike.html https://biospectrumindia.com/news/95/2487/all-statins-are-not-alike.html Thu, 11 Dec 2003 19:05:00 +0530 A study comparing two powerful cholesterol-lowering drugs has found that both are not equally effective. It was found that in patients taking pravastatin or Pravachol heart disease worsened slowly over 18 months. But the disease was halted in those who took the highest dose of atorvastatin, or Lipitor, another statin. The study was done on 502 patients and it was found that in those taking Atorvastatin the level of low-density lipoproteins (LDL), which carries cholesterol to arteries, dropped from 150 to 79 while those taking pravastatin it reduced to an average level of 110. After 18 months, the atorvastatin patients had no change in the plaque in their arteries, but plaque increased by 2.7 percent in pravastatin patients. The study assessed the progression of atherosclerosis using a tiny ultrasound camera that was inserted into coronary arteries, allowing researchers to look directly at the growth of plaque. Though the study did not assess patient outcomes like heart attacks and deaths and additional studies will be needed to assess whether different statins would cause disparate reductions in clinical outcomes. But the study did raise a basic question that how low should the cholesterol go and how low is low enough. Today with modern drugs it is possible to reduce the cholesterol to a very low level, but the impact in terms of costs of drugs, side effects of drugs and prevention of heart attacks is not known. Large studies are under way seeking to determine if more plaque growth means more heart attacks and deaths. Researchers suspect that it is the case, based on their recent understanding of how plaque in artery wall can kill. This opens a possibility of stopping the disease process and preventing most heart attacks from ever happening. New psoriatic arthritis gene discovered A new gene in psoriatic arthritis has been discovered by a Canadian research team. This offers hope for the development of targeted drug treatments and better diagnosis of the disease. Psoriatic arthritis is associated with psoriasis. It causes skin rashes and produces painful joint inflammation. It is a less common form of arthritis, occurring in 0.5 to 1 percent of the population. Psoriatic arthritis can occur in upto 20 to 30 percent of patients with psoriasis, and can range from being a mild disease to an illness associated with significant morbidity. At present there is no cure for psoriatic arthritis and patients are treated with anti-inflammatory drugs and occasionally drugs that alter their immune system. These therapies primarily focus on treating the symptoms of the condition, mainly because of a lack of understanding concerning the biology of the disease. Now there is a growing body of evidence that psoriatic arthritis has a strong genetic component and often runs in families. The study resulted in the discovery of the CARD15 gene being associated with the disease. "For most such diseases there are usually multiple genes involved, so having one gene account for 30 percent of cases, which can be helpful for diagnosis. Especially in cases where the psoriasis, which normally occurs with psoriatic arthritis, has not yet developed," said Dr. Proton Rahman, a rheumatologist at Memorial University of Newfoundland, who headed the study. His initial study indicated that patients with CARD15 required more medication and had more surgeries than other people with psoriatic arthritis. His research team is now investigating whether the CARD15 gene is useful for predicting severe cases of psoriatic arthritis. If it does prove to be a "marker" for severe disease, it may lead to treating patients with the gene earlier and more aggressively to prevent their arthritis from progressing. In a follow-up study to his initial research, Rahman said that his group is now trying to determine the function of the CARD15 gene, which at this stage has only been labeled a "susceptibility" gene â€“ meaning it is not yet proven as a cause of the disease. He suspects the CARD15 gene has a much larger role to play in the development of psoriatic arthritis, and through further research he hopes to reveal the extent of that role. If it is confirmed that CARD15 affects the development of psoriatic arthritis, it could lead to new treatments for the disease. The gene could become a target for molecular-level drug therapies, which are designed to block the disease-influencing activity of specific genes. The Memorial University of Newfoundland has applied for an U.S. patent for the gene. The application focuses on the potential use of the gene to diagnose psoriatic arthritis. Pyramiding insecticidal genes in crops for delayed resistance Cornell University scientists have found that using crops bearing two different toxin genes in the same plant (pyramiding) can delay resistance development in the target pests. Today much of the biotech research is directed towards developing insect/pest resistant plants. These genetically modified plants containing insecticidal genes have the advantage of surviving the onslaught of insects, which in turn benefits the environment by reducing the use of chemical insecticides. But evolution of resistance to the insecticidal toxins in the target insects could nullify such gains. Use of two different transgene plants grown sequentially, in mosaics or by mixing genetically engineered seeds, or by pyramiding can reduce the resistance build up in insects. Dr. Jian-Zhou Zhao, department of entomology, Cornell university and colleagues did an evaluation of the efficiency of various methods in delaying insect resistance in a model system and showed that by far the most efficient method is pyramiding. They developed a unique model system consisting of Bt transgenic broccoli plants and the diamondback moth, Plutella xylostella. Zhao along with his team conducted a greenhouse study using an artificial population of diamondback moths carrying genes for resistance to the Bt toxins Cry1Ac and Cry1C. They found that after 24 generations of selection, resistance to pyramided two-gene plants was significantly delayed as compared with resistance to single-gene plants deployed in mosaics. It was also observed that Cry1C resistance evolved more slowly than Cry1Ac resistance due to the multigene control of resistance for Cry1C as opposed to single autosomal inheritance for Cry1Ac. These results have implications for the current use of single transgene plants as well as for growing strategies in the future. The details of the study have been carried in the November 10 issue of Nature Biotechnology. ]]> <![CDATA[Automed introduces Breederâ€”a flexible Incubator]]> https://biospectrumindia.com/news/95/1694/automed-introduces-breedera-flexible-incubator.html https://biospectrumindia.com/news/95/1694/automed-introduces-breedera-flexible-incubator.html Thu, 11 Dec 2003 18:54:00 +0530 Automed introduces Breeder Automed introduces Breederâ€”a flexible Incubator Automed along with its international partner Wheaton Science Products has launched the Breeder, a flexible, foldable incubator for cell culture, in India. This portable incubator can be easily stored by collapsing and folding. It is made of flexible plastic and fibers, with a control unit containing the temperature control sensors and heaters. It is positioned as a low cost alternative to a standard incubator for roller culture applications. The breeder is less expensive than a standard incubator and frees up valuable space for other experiments. The roller rack with the Breeder can be easily moved to accommodate laboratory space and traffic requirements. They can also be moved as one unit to allow more convenient working space (bottle filling near laminar flow hood, so the roller rack provides a place to put the bottles and the risk of contamination is reduced). It can monitor the temperature of the culture environment and report it to a PC for logging purposes. For further details, contact: sales@automedsystems.com Domino brings out a new coding equipment Domino Printing Sciences Plc, a leading solution provider for printing and coding solution to pharma sector, has introduced Domino S200 for high quality coding of products. The S200 produces a sharp, indelible code on a wide range of materials, both moving and stationary. It is ideal for coding packages and products in food, beverage, pharmaceutical and personal care markets with its flexibility to mark serial numbers, batch codes, bar codes, 2D codes, logos, graphics, or complicated European and Asian characters. Domino's S200 is simple and easy to use. Its user interface is an innovative colour touch-screen with WYSIWYG display. Together with intuitive Windows® based software, it allows for quick message entry and editing. The S200 has the latest range of micro laser, resulting in smallest and lightest laser head in its class. For further information, contact: marketing@dominoindia.com MantaRay, a suspension culture flask from Automed Automed along with Wheaton Science Products has introduced a disposable suspension culture flask called MantaRay. This is an unbreakable, safe, pre-sterilized and single use cell culture vessel to grow suspension cell cultures. It is made of flexible plastics, saves space, comes with a gentle, efficient stirrer and is ready to useâ€”complete with magnet. MantaRay is used for growing cultures of mammalian cells, but can also be used for plant and insect cells. Its proprietary stirrer technology is designed to minimize damage to fragile cells, such as mammalian cells. The culture flask also allows media and gasses to be added or changed during the experiment under sterile conditions and it can culture cells on micro-carrier beads, which the cells use as a growth surface. The product is targeted at universities, pharma, institutes or companies performing cancer research, producing proteins, enzymes or antibodies and researchers in insect and hybridoma cell cultures. For further details, contact: sales@automedsystems.com   ]]> <![CDATA[Meena Gupta is new GEAC chief]]> https://biospectrumindia.com/news/95/1975/meena-gupta-is-new-geac-chief.html https://biospectrumindia.com/news/95/1975/meena-gupta-is-new-geac-chief.html Thu, 11 Dec 2003 18:49:00 +0530 The nation's biotech regulatory agency, the Genetic Engineering Approval Committee (GEAC) has got another chief. Meena Gupta, a 1971 batch IAS officer of the Orissa cadre has assumed office as the chairperson of the agency, which is part of the Ministry of Environment and Forests (MoEF). She is the fifth chief of this regulatory agency in 2003. Gupta is also an additional secretary rank officer in the same ministry. She chaired the November 27 GEAC meeting which decided to ask the Drug Controller General India to submit an inquiry report on Shankinase, a recombinant streptokinase by Hyderabad-based Shantha Biotechnics. The drug was earlier given clearance by the GEAC. Bureaucratic circles are very impressed with her handling of the health issues in the aftermath of the supercyclone that hit the Orissa coast in 2001. Gupta moved to the MoEF in January 2003. Prior to that, she was the health secretary of the Orissa government. She had been assigned the GEAC role briefly early in 2003. "Since certain formalities are still required for this procedure (GEAC role), I don't have enough words to say or comment about it. There is no doubt that it is a challenging job. But all I am concerned at the moment is to fulfill the expectations of ministry and come out with positive results," she told BioSpectrum when contacted. Sushil Kumar may be GEAC co-chairman The government may beef up the GEAC with the induction of at least four scientists as permanent members. Most of the other members participate in GEAC as ex-officio member. Well-known plant biotechnology and plant genetic specialist Sushil Kumar is likely to take over as the co-chairman of GEAC immediately. Kumar was earlier the director of the Central Institute of Medical and Aromatic Plants (CIMAP), Lucknow. CIMAP is a leading laboratory in the CSIR chain. The 63-year old scientist is currently a professor at the National Center for Plant Genome Research (NCPGR) in the JNU campus, New Delhi. Sources in the government said three other scientists are also likely to joint the GEAC. They are: Dr AK Bhatnagar, a professor in the Department of Botany, University of Delhi; Dr RP Sharma of the National Research Center on Plant Biotechnology, in the Indian Agricuture Research Institute, New Delhi and Dr Subhash Chand, a professor at the Indian Institute of Technology, Delhi. Dr Bhatnagar has specialized in Reproductive Biology and Environmental Biology and is a well-known personality in the agriculture research community. His most recent work was on the influence of cadmium on the growth and development of Vicia faba Linn. His works on algae dependent bio-remediation of hazardous wastes has also been well recognized. Shyamal Pal joins Sherman Shyamal Pal has joined Sherman International, which is into designing and manufacturing biotech instruments like bioreact-ors, fermentors and cell culture systems. As manager, business development, Sherman he is handling several analytical, environmental and biotech products and also looking after projects and activities for manufacturing fermentors, bioreactors and cell culture system. Prior to this he was with Chemito Instruments where he developed the biotechnology division. He was the first to introduce bioreactor/fermentor in Chemito. With a strong theoretical background he has successfully designed the reactors and introduced automated colony counting system for the first time in India. Having done his masters in microbiology and biotechnology from Vidyasagar University and PhD in agricultural microbiology at B R Ambedkar University, he started his professional career as product executive with Labmate Asia Pvt Ltd .   ]]> <![CDATA[India, Syria to cooperate in biotech]]> https://biospectrumindia.com/news/95/2884/india-syria-to-cooperate-in-biotech.html https://biospectrumindia.com/news/95/2884/india-syria-to-cooperate-in-biotech.html Thu, 11 Dec 2003 18:47:00 +0530 AB Vajpayee and President Assad of Syria jointly inaugurating the Biotech Center in Damascus In its bid to go beyond the national boundaries, India has signed a joint work plan with Syria for bilateral cooperation in biotechnology research. The Executive Work Plan, signed on November 15 on the occasion of the Prime Minister AB Vajpayee's visit to Damascus, has a five-year road map for joint research in varied areas of biotechnology. India has also announced a $1 million grant for the development of Syria's National Biotechnology Center. The Executive Work Plan calls for bilateral cooperation through increased institutional collaboration for joint research activities, and exchange of scientists and technical information. Announcing the grant after the inauguration of the National Biotechnology Center, the Prime Minister hoped that it would be utilized for establishing a high-quality facility. Vajpayee said such a facility would not only benefit the people of Syria, but also contribute to the improvement of the quality of life of all people in the region. "It would also be a powerful demonstration of the immense peaceful and developmental applications of biotechnology," Vajpayee added. According to an official statement released by the Prime Minister's Office, Vajpayee stated that the center symbolizes the transition of Indo-Syria relations from its traditional roots to the contemporary age. Through scientific partnerships and alliances, the countries can create value-addition to innovation and commercialize technologies for products, which increase human welfare, Vajpayee believed. Switzerland, India to set up biotech forum Pascal Couchepin, President of Switzerland, announced that Switzerland and India have initiated measures to set up a Swiss-Indian Biotech Forum to promote interactions between Swiss and Indian biotechnology companies and institutions. Switzerland has also identified a few Indian sectors as biotechnology, power, and textile machinery as priority areas to strengthen business collaborations. He was speaking to captains of Indian Industry, in a meeting organized by the Confederation of Indian Industry (CII) and Federation of Indian Chambers of Commerce and Industry (FICCI), in New Delhi. Pascal Couchepin added that in addition to the bilateral framework, Switzerland and India adhere to WTO multilateral approach and both need a strong and rule-based multilateral trading system. He said that for both countries, the failure at Cancun has been a negative result but expressed happiness that both India and Switzerland are hopeful that the Doha negotiations will start sooner than later. Referring back to bilateral relations, he said that a new bilateral government agreement to intensify cooperation in the fields of science technology was inked and expressed optimism that the new initiative would lead to increased economic interactions between the two countries in the years to come. In his address, Vinod Khanna, minister of state for external affairs, Government of India, said that bilateral trade in 2001-02 of $1 billion was well below its true potential. He said that the signing of two bilateral agreements was significant in view of the potential for synergetic relationship. Khanna added that the agreement would help combine the strengths in research for mutual benefit and enable explore new avenues of cooperation in biotechnology, nano-technology, life sciences, genome research and environmental technologies, where the Swiss have made considerable advances. In his welcome address, KK Modi, past president, FICCI, said that India and Switzerland have grown to be ideal partners in diverse fields. He said that there were tremendous opportunities for the two countries to join hands in the areas of IT, biotechnology, telecom, e-commerce, health care, chemicals, pharmaceuticals, engineering, agri-business and other areas of applied R&D among others. Frankfurt woos Indian biotech firms Frankfurt is ready to welcome Indian and other Asian biotech companies. Frankfurter Innovationszentrum Biotechnologie (FIB) is spearheading this drive and is talking to companies like Shantha Biotech and Biocon. FIB is a unit of the Frankfurt Economic Development Corporation, set up to promote investments in Frankfurt. FIB will be providing contacts with huge German pharmaceutical companies. It also plans to set up a 30m Euro venture capital fund, which will co-invest in research and development projects that Indian biotech firms undertake in collaboration with a German body. Further, Roland Koch, Prime Minister of Hessen State, is expected to visit India early next year to push ahead this project. Koch is scheduled to meet Indian IT and biotech companies in Hyderabad and Bangalore. Roche Scientific to invest Rs 33 crore in India Dr GL Telang, MD, Roche Scientific (India Roche Scientific Company (India) Pvt Ltd (RSCIPL), a wholly owned subsidiary of F Hoffmanâ€”La Roche plans to invest over 10 million Swiss Francs (about Rs 33 crore) in India over the next fiscal year. The investment areas will entail initiating global clinical trials in India, new therapies and extended access programs, said Dr GL Telang, managing director, RSCIPL. Briefing the media about the future plans of the company Dr Telang said, " Roche India will increase its present strength from 40 to 55 by mid next year." Roche which has sold therapies worth more than 35 million Swiss francs in India in areas of oncology, virology, transplantation and in general pharma segments including areas like osteoporosis and epilepsy announced a reduction of prices of its existing therapies like Xeloda, Mabthera, and Cellcept by nearly 25 percent. With this Xeloda will now be available at Rs 18,000 down from Rs 30,000 per therapy, while the treatment cost of Mabthera has been brought down to Rs 80,000 from Rs 95,000. Cellcept will now cost Rs 16,500 instead of Rs 23,000 and the price of Herceptin has been reduced to Rs 100,000 from Rs 120,000, said Sangita Topiwala, head (planning and development), RSCIPL. "Our decision to further invest in the country and reduce the prices of the therapies, reflects Roche's continued commitment to the Indian healthcare community and to innovation in scientific research," Dr Telang said. Roche is also looking at introducing therapies in the areas of dermatology and osteoporosis in India. Therapies like anti-CMV and treatment of bone metastasis are in the pipeline for India in the coming year, he added. "Roche's focus is not just the diagnosis and treatment of manifest diseases. The integrated healthcare approach is increasingly offering ways of identifying and targeting diseases early, when their damaging effects can still be prevented and we intend to follow the same international practices of Roche in India, " said Juerg Haefelfinger, deputy director, Roche Pharmaceuticals, Basel. Continuing he said the Roche has 67 compounds in its portfolio, which are under phase 1-3 clinical trials. Roche is in the business of "complete healthcare solutions", which includes diagnosis, treatment and monitoring. It has plans to introduce Avastin and Valcyte as part of its extended access program wherein a molecule, which is in an advanced stage of trials internationally, will be made available for treating Indian patients. However, Dr Telang clarified that the product introduced through this program may not necessarily be marketed in India. This extended access program would enable hands on experience for the Indian physicians and the ready availability of the treatment for needy patients. Cadila Healthcare develops complex typhoid vaccines Ahmedabad-based Cadila Healthcare Ltd (Zydus Cadila) is understood to have developed complex typhoid vaccine. Besides, it has developed recombinant protein products, which are presently undergoing toxicological studies. So far Cadila Healthcare has 41 Indian patents and 42 patents in foreign countries to its credit. As an opportunity-focused organization, Cadila Healthcare believes that the biggest investment that an organization can make for tomorrow is by investing in research today. It has started working on developing and adding new products to its basket. It has a strong technical team of 300 people in its research program. The company's research focus comprises coverage of synthetic organic chemistry, process research and drug delivery (NCE, NDDS, biotechnology) with a growing focus on rapidly growing lifestyle-induced diseases. The company's divisions, Zydus Biogen and Zydus Pathline, focus on immunologicals, vaccines, and diagnostics. In the year 2002-03, its biological and diagnostics product revenues accounted for nearly 2 percent and 3 percent share of its consolidated revenues of Rs 1,130 crore, respectively. The growth initiatives are likely to remain a sustainable feature of the company. It has also entered into a win -win alliance with Berna Biotech of Germany and Biosidus of Argentina, which enjoy a deep therapeutic presence in vaccines and in biotechnology. Global outsourcing market is increasing at 12% Dr G Hughes, scientific director, Technomark Consulting Services The $10 billion global outsourcing market for drug development is growing at 12 percent per annum said Dr Graham Hughes, scientific director, Technomark Consulting Services Ltd. Although there are about 1,600 CROs of various types in the world, Dr Hughes said only top 20 CROs have a market share of over 60 percent and this share is increasing. Of which over 50 percent are in public sector. Against the rise in the R&D expenditure on developing New Chemical Entities (NCE), there has been a fall in the number of NCEs. This is making the cost per NCE to rise relentlessly. Citing the trends in the R&D, Dr Hughes noted that development times are not speeding up. The number of subjects shows little variation in recent years. Fewer trails are included in the dossiers. To over come these, he suggested to speed up the R&D activities and to reduce the time to market the product. Increasing the efficiency, reducing wastage, and concentrating on major indications will help cut the cost on R&D per NCE. The industry is under unprecedented pressure and the companies are reluctant to change to different types of outsourcing. To over come these, he said, CROs have to look at other industry strategies. Companies have to judiciously balance between strategic and tactical outsourcing as strategic outsourcing takes time to implement and must be continually worked, as it isn't easier than the tactical outsourcing. Strategic outsourcing needs top-down corporate-wide approach and also needs attitude changes across the company. "In CROs, outsourcing is regarded as a core competency, while in other industries attitudes are characterized by trust, openness, long-term thinking, partnership, risk sharing and quality," added Dr Graham Hughes Intas to launch biotech product by Q1 of 2004 Dr Urmish Chudgar, director, Intas Pharma Experienced in the marketing of bio-generics and hepatitis B vaccine in the domestic market, Ahmedabad-based Intas Pharmaceuticals Ltd, has decided to install dedicated manufacturing infrastructure for development, manufacture and marketing of pharmaceutical products obtained through "recombinant DNA biotechnology". Speaking to BioSpectrum, Dr Urmish Chudgar, director, Intas Pharma said the company has already invested Rs 26.50 crore in the project. The total project cost when fully completed is estimated to be Rs 35 crore. The maiden product would shortly undergo phase III clinical trials and is slated to hit the domestic market by the last quarter of this fiscal year. The company has also received permission to carry out animal toxicity studies on other products too. Intas, with support from Technology Development Board, government of India, developed two protein-derived productsâ€”fabrin glue and lyophilized cryoprecpitates. Dr Chudgar added, "The opportunities in biotechnology and oncology products in the international markets give us the momentum to grow in near future." It has embarked on an intensive program for development and analytical testing of new formulations including biotech formulations, with the objective of partnering with top multinationals for formulation research and providing regulatory support. An independent facility equipped with modern technology and manned by professionals is the focal point of this initiative. Intas Pharma, besides stressing on newer areas like biotechnology and oncology, continues to focus on cardiovascular, neuropsychiatry and gastroenterological and pain management therapeutic segments. Intas has a good international presence. About 20 percent of its current turnover of Rs 293.23 crore is on account of exports to Latin American, East Asian and European markets. Intas further intends to enhance its global presence on its technology strengths and the quality of its products. It has initiated marketing operations in developed markets with objective of achieving a critical mass and intends to form strategic business units to expand its operations in the US, UK and the rest of Europe. Synchron to double its revenuesAhmedabad-based Synchron Research Services Pvt Ltd, one of the top five contract research services organizations in the county, is targeting to double its revenue by end of this fiscal. For the year ending 2002-03, Synchron's revenue stood at around Rs 2.5 crore. Speaking to BioSpectrum, Shruti Shukla, senior manager, business development, Synchron said, "We offer services designed to meet the specific needs of clinical development and registration of new pharmaceutical products and medical devices. We ensure confidentiality, reliability and quality to the sponsor. We adhere to the international standards of good clinical and good laboratory practices." The experienced and qualified team at Synchron includes physicians, clinical pharmacologists, pharmacists, pharmaco kineticians, biostatisticians and other graduate staff. Starting with 12 beds, its clinical research unitâ€”focusing on bioavailability studiesâ€” has a facility of 28 beds with adequate recreation and dining facilities to participating volunteers. "Now we are planning to increase the capacity to 36 beds," Shukla added. Synchron has an onsite analytical laboratory, which houses sophisticated analytical instruments. It develops and validates bioanalytical methods according to ICH guidelines in a variety of matrices in support of clinical studies. To monitor the activities of the clinical studies, it has an independent ethics committee. "The ethics committee is headed by Prof. NS Parmar, director, institute of pharmaceutical sciences, Nirma University of Science and Technology, Ahmedabad and includes a practicing dental surgeon, social worker, advocate and some lecturers from the pharmacy colleges," she added. "We have tied up with Covance to conduct phase I clinical trails. Our clients' list includes Wockhardt, Cipla, Shantha Biotech, Bharath Biotech, Alembic and Torrent. Since clinical trials /bioequivalence is a small part of the drug delivery system we find no competition in the CRO space in India, as we have been getting repeated satisfied clients," said Shruti Shukla. "I feel India needs 20 more CROs. India has more population with diverse patients' lists. We have less over heads compared to CROs in western world," she added. Synchron offers feasibility studies, protocol development, investigator identification, independent ethics committee submission, regulatory affairs, clinical trail co-ordination, clinical trial project management data management, statistical data analysis, GCP training courses and bioavailability and bioequivalence studies. In the last four-and-half years, Synchron has done 110 bioequivalence studies and 10 clinical trails of which two studies have been completed. Synchron is also planning to tie up with the Nizam Institute of Medical Sciences to conduct bioequivalence studies. Molecular Connections expands Molecular Connections announced that it has expanded its infrastructure and moved the development center to a new location in Bangalore. The move will enable the company to enhance its service capabilities to meet the growing curation and annotation needs of its customers. Commenting on the move, SR Vaikuntanath, vice-president (finance and administration) mentioned, "By using our ODC facility, partners can fulfill their needs for of high quality informatics service at lower costs and faster turnaround time along with high-regard for intellectual property." Molecular Connections is a joint venture between Idea2solutions, an incubator promoted by the founders of the Dr Reddy's group and Institute of Infocomm Research, Singapore. It utilizes proprietary Natural Language Processing (NLP) based tools and expert in-house scientists to extract key biomedical information from literature and public databases. It has built Netpro, the single largest database of more than 30,000 protein-protein interactions extracted from literature and expert validated manually. APIDC gets fresh commitments, CSIR to seek funds for its biotech projects Sarath Naru, MD,  APIDC fund India's first national fund focused on biotechnology companies, APIDC-VCL, has received fresh commitments for Rs 10 crore from Bank of Baroda and Rs 5 crore from Punjab National Bank, taking the total to Rs 56 crore. It targets a total of Rs 150 crore corpus. It had earlier got commitments from various financial institutions, including Andhra Bank, LIC, GIC, UTI Bank besides the Andhra Pradesh government. It has invested to a tune of Rs 8 crore in Bioserve, Biotechnology, Genomik Design Pharmaceutical and Silico Insights. In another development, The Council of Scientific and Industrial Research (CSIR) is in talks with APIDC Venture Capital for partnership for biotechnology projects. CSIR has a number of labs that are working on significant projects and APIDC Venture Capital will work with these labs to identify technologies and products that are currently under development and catalyze the process of bringing them to the market. "The idea is to work actively with these labs, identify their intellectual property and commercialize it," said Sarath Naru, managing director of the fund. Naru added, "CSIR has the distinction of filing about 184 patents in 2002. About 5-10 percent of the research can be commercialized. APIDC has already chosen 11 technologies, but it will shortlist and is expected to end up with four products." The project is modeled on similar lines like the Beacon Venture, a fund that is working with Boston University. Two new facilities come up for Millipore India Francis J Lunger, chairman, CEO and president, Millipore, dedicating the Millipore India Process Development lab in Bangalore Francis J Lunger, chairman, CEO and president, Millipore, dedicated the Millipore India Process Development and Access Services laboratories in Bangalore in November. The Process Development Lab will assist Indian biopharmaceutical companies in developing and scaling up manufacturing processes for new biopharmaceuticals. Millipore provides key products and technologies for the scale-up of biotherapeutics, including chromatography and membrane technology. The firm also provides expertise in process engineering and protein chemistry. Millipore India's Access Services Lab, the fourth of its type in the world, will assist Indian biotech and pharmaceutical customers in meeting their quality standards, and in meeting stringent local and international regulatory requirements. The lab will conduct validation, microbiological analysis and retention studies. It will also provide the much needed support and services to biotech and pharmaceutical companies for microbiology training and offsite services including quality systems, audit support, and process optimization. Sudhir Kant, president, Millipore India, stated that the two new labs will help meet long-term needs of the pharmaceutical and biotechnology industries. Kant also noted that Millipore India was partnering with the Biotech Institute to offer a structured and practical course for training of MTech (biotechnology) students. There is a shortage of such trained professional people in India, and worldwide. Nandan Agro to unveil new formulations Nandan Agro Farms is working on preparing seven formulations from an indigenous medicinal plant, safed musli. Botanically called chlorophytum borivilianum, the medicinal plant is rich in herbal steroids and versatile in therapeutic value. Nandan's first product, Bio Rhythm, has been positioned as the answer for Viagra. During the last seven years, the company has set up a commercial farming base for safed musli in various states through contract farming. Accelrys to increase its Bangalore workforce Mark J Emkjer, president, Accelrys Accelrys, the software subsidiary of Pharmacopeia Inc., a company involved in developing technology for better drug discovery, will be increasing its workforce in its Bangalore R&D center. The company whose Center of Excellence in Bangalore has been functioning since February this year said that it will continue to invest in its Indian operations. "We have presently close to 50 people in the R&D center here and we will be looking to increase that to more than 100 in the next eight months time," said Accelrys president Mark J Emkjer. The company has similar R&D setups in San Diego, USA and Cambridge, UK. According to the company, the Bangalore center will be working on all its informatics products including chemical and material informatics product lines along with porting of two of its products to the Linux platform. The Accelrys product line spans the segments of bioinformatics, cheminformatics, matinformatics and modeling and simulation software. The center will also work on creating a common architecture and a unified, integrated platform for all the products. "Traditionally most of our products have been confined to the Unix platform. The Bangalore team is currently involved in porting two of our expert modeler programs, Insight II and Catalyst, to the Linux platform. Both products should be introduced to the market by the end of the year," said Emkjer. Accelrys has partnered with IBM for this specific project. He added that as far as the server side was concerned, "the battle is already won" by Linux but Windows will continue to rule on the desktop side for sometime in the future at least. The company is conducting a survey among its customers and will be ready to port products as and when customers evince interest on the same. Accelrys India Operations VP Harsha Patel added, "As far as high end, modeling and simulation products are concerned, I think there is huge potential and opportunities for growth for Linux. It is the lower end of software, like the spreadsheet and word processing, that will continue to be dominated by Windows for sometime." Emkjer also said that the company would be interested in future acquisitions of companies close to the space in which it operates. According to him, Accelrys should have a list of prospective companies to go after by the end of this year. When asked about whether the list will contain any Indian companies, Emkjer refused to comment though he did not deny the possibility. The company, which was formed in 2001 as an amalgamation of five companies, notches close to $100 million in revenue, with US contributing 50 percent the rest being divided among Europe and APAC. Emkjer believes that the biotech industry can see a better future if it adopts the process of 'co-opitition', where companies will work together, accelerate the drug discovery process and bring down drug costs. He also believes that such integration is not far in the future. This head of the software arm of Pharmacoepia Inc., whose products aid in the drug discovery process, believes that the Bangalore R&D center forms a strategic link in the company's development plans and promises huge investments into the same. Sathya Mithra Ashok   Gujarat to release BT policy in late December The government of Gujarat is expected to release the draft biotech policy by December-end or January next year. The sources in the government said that the draft report was ready and it will be placed before the cabinet for approval. Rajesh Kishore, secretary, Department of Science and Technology, government of Gujarat, said, "We have carefully studied the biotech policies of other states. We have taken all steps to give prominence to promote biotech industry in a big way in the state. We have tried to provide the best biotech policy."   GIDC developing Biotech park at Vadodara The Gujarat Industrial Development Corporation (GIDC) has already commenced the development of biotech park at Vadodara. GIDC earmarked 90 hectares of land at Savli near Vadodara. The park will be equipped with incubator with standard design, state-of-the-art common R&D lab, technology and information center and research institute.     ]]> <![CDATA[GEAC in the eye of another storm]]> https://biospectrumindia.com/news/95/2676/geac-in-the-eye-of-another-storm.html https://biospectrumindia.com/news/95/2676/geac-in-the-eye-of-another-storm.html Thu, 11 Dec 2003 18:40:00 +0530 It looks like India's leading biotech regulator, the Genetic Engineering Approval Committee (GEAC), can't avoid controversiesâ€”whether for not doing enough for the industry or for whatever decision it takes once in a few months. The latest issue is the controversial decision of GEAC on 27 November to ask the pharma regulator, the Drug Controller General of India (DCGI) to inquire how Hyderabad-based Shantha Biotechnics has started "illegal" manufacture of the biotech drug Shankinase. "According to DBT protocol, GEAC has no role to play in granting approvals for clinical trials. All clinical trials are approved by DCGI Advisory Committee, after it has been duly approved by Institutional Biosafety Committee (IBSC) and Review Committee on Genetic Manipulation (RCGM)," Varaprasad Reddy, MD, Shantha. More damaging to Shantha Biotechnics, a torch bearer of modern biotechnology which has won universal acclaim for its pioneering drugs, was the GEAC's prompt press release the same day which said it has "requested DCGI to conduct a full inquiry into the incident (manufacture of recombinant Streptokinase branded Shankinase without its prior approval) and the reported deaths of some patients during the trials." "A final view on what action needs to be initiated against the erring company will be decided after getting all reports," the GEAC press release added. GEAC is the regulator for genetically modified products and is part of the ministry of environment and forests. It is chaired by additional secretary rank official, Meena Gupta and has ex-officio members drawn from other wings and scientific agencies of the government. Ironically, the GEAC decision was taken on a day, when just 500 meters away from its office, some of the country's top biotech experts, NGO activists, industry representatives and scientists were debating the very relevance of GEAC as a bureaucratic regulator whose decisions were far removed from reality. The meeting was organized by leading genetic activist Dr Suman Sahai to celebrate the 10th anniversary of her organization, Gene Campaign. In fact, a few hours after the GEAC meeting, two senior officials of the regulatory agency put up a spirited defence of the organization for nearly two hours at the NGO meeting and unveiled the roadmap to a transparent regulatory regime. In Hyderabad, Shantha Biotech-nics was quick to challenge the GEAC decision. Within 24 hours, Shantha released its side of the story at a media conference and reaffirmed that its manufacturing and trials of the blood-clot busting drug were perfectly in order and followed all the regulatory processes in the country. The tenor of Shantha's managing director Varaprasad Reddy was that GEAC had no business to poke its nose into something which was not in its mandate. "According to the Department of Biotechnology protocol, GEAC has no role to play in granting approvals for clinical trials. All clinical trials are approved by DCGI Advisory Committee, after it has been duly approved by Institutional Biosafety Committee (IBSC) and Review Committee on Genetic Manipulation (RCGM)," Reddy asserted. Shantha's argument that GEAC had no business in this issue has found widespread support in the industry. "It is evident that the roles of GEAC, DCGI and RCGM are not clearly defined. I am in agreement with Shantha's view on the matter: i.e., GEAC does not come into the picture when it comes to granting permission for pre-clinical and clinical trials. This is the role of RCGM and DCGI. Hence Shantha has certainly not deviated from the norms," asserted industry leader and president of the Association of Biotechnology-Led Enteprises (ABLE) Kiran Mazumdar-Shaw." According to the current regulations, GEAC's role is confined to approving the use of the recombinant drug as it uses an altered genetic material and GEAC has given this approval a few months back. Then the drug goes through the normal regulatory approval, proves as prescribed by the DCGI which involves a host of clinical trials, and the data is vetted by the drug controller. After this process is over, being a gene-based drug, it will have to go to the GEAC for final approval for manufacturing and commercial release. This is clearly stated in the approval letter issued by the DCGI. "I understand that Shantha has provided all the data pertaining to the trials along withinvestigators' report and I am inclined to accept Shantha's contention that Streptokinase which is used as a clot buster for myocardial infarctions does carry the risk of fatality and statistically the current information does not indicate any fault in the product," Mazumdar-Shaw added. Shankinase too was approved by DCGI for Phase III clinical trials in various centers across India. Randomized multi-centric double-blind comparative trials were conducted in Hyderabad, Bangalore, Pune, Lucknow and Mumbai, in which the safety and efficacy of Shankinase was compared with the international innovator brand of Streptokinase. The conclusion of the investigators, which is signed and submitted to the DCGI, states that the product generated results that were "absolutely satisfactory and safety was comparable" with the international brand, according to the company. The trials' data was submitted to the DCGI as per the correct procedure and found satisfactory and approval was granted for manufacturing stated Reddy. A Hyderabad-based NGO had reportedly complained to the GEAC that some deaths had occurred during the clinical trials. The GEAC decision to ask for an inquiry by the DCGI was based on this complaint. Shantha chief clarified that there were a total of six deaths reported in the Double Blind Comparative Clinical Trial of Shankinase vs Best Known International Brand. In the Double Blind trials, vials of both the brands are masked and the identity is not known to the investigator, the patient and the company. A total of 134 patients with myocardial infarction were administered both these products, across six hospitals in five cities in India. When the results were decoded, it was found that three deaths occurred in the group administered with Shankinase and an equal number (three) of deaths occurred in the group which was administered the international brand. "It has to be noted with responsibility that the patients who are administered Streptokinase are patients with acute myocardial infarction (heart attack) and there is an acceptable efficacy benchmark (60-70 percent) seen throughout the world with this product. Since this is a drug for an emergency situation for seriously unhealthy patients, some deaths are bound to occur in any large-scale trial," stated Reddy. In fact, Reddy said, it was for this very purpose that the ethical committee of the principal investigators chose to conduct a Comparative Double Blind Clinical Trial so that all biases could be eliminated. Thankfully, because of this decision by the investigator, the results submitted by the principal investigators have been accepted by the DCGI. Firing a salvo at the GEAC for not sticking to its mandate, Reddy asked: "It would be interesting to know whether GEAC has ever taken any cognizance of the deaths in the clinical trials of Streptokinase or any other product, conducted recently or in the past by Indian manufacturers or foreign companies. It is an irony that the GEAC gives environmental clearance to imported products even before clinical trials are conducted, whereas it expects products developed in India to go through it seeking their approval for clinical trials as well as final clearance for manufacturing." Ironically, the 27 November GEAC statement also contains the information that it had approved the introduction of many imported biotech drugs in the country. The GEAC has not clarified whether the rigorous trials of these drugs had been conducted within India. As a process, GEAC relies on the Department of Biotechnology (DBT) for scientific inputs. The Review Committee on Genetic Manipulation (RCGM), constituted by the DBT and chaired by a scientist, and the Institutional Biosafety Committees in all organizations conducting experiments on genetically modified products are the key agencies in this sector. All pharma products are first vetted by the DCGI which uses medical experts drawn from the Indian Council of Medical Research (ICMR). The November issue of BioSpectrum had reported the extensive use of illegal Bt cotton seeds, the country's first officially approved product, in many parts of Gujarat. A GEAC inquiry which tested 10 randomly drawn samples of these spurious seed brands had confirmed the use of "unapproved" Bt genes. Yet the GEAC is not in a position to take any action. GEAC officials have admitted that a stringent action may create a "socio-economic" crisis in the state. The Gujarat state government which has to take action against these practices is reportedly supporting the use of these illegal seeds to benefit its farmers. It indeed is a strange regulatory system we have for genetically modified products in India. N Suresh India, US shake hands in biotechThe renewed friendship between India and the US after September 2001 is manifesting itself in many areas. Biotechnology and life sciences is certainly a top priority area for both countries. This was amply demonstrated by the dialogue between both countries under the Indo-US High Technology Cooperation Group (HTCG) involving top policy makers, industry organizations and captains of India's industry on November 19, 2003 in Bangalore. "High technology is key to the cooperation between both the countries in fostering bilateral trade," remarked Kenneth I Juster, under secretary of commerce, Bureau of Industry and Security of the US Department of Commerce and the key American interlocutor. HTCG was set up in November 2002 to take forward the discussions between Prime Minister AB Vajpayee and US President George W Bush a year earlier in Washington. The first meeting of the group was held in July 2003 in Washington D.C. The second in the series was the one in Bangalore. Both the governments have identified three key areas for cooperation in high technology. These are: 1) Defense 2) Information technology and nanotechnology, 3) Biotechnology and life sciences. The new found friendship and cooperation has resulted in improving high tech exchanges between India and the US which were suspended following India's nuclear tests in May 1998. "Now less than one percent of India's exports to the US involve higher scrutiny and licensing. There were some 700 applications for technology export/import licenses from India compared to 900 from Japan. The approval rate for Indian applications was over 90 percent," informed Juster. India has a lot to gain from the cooperation, said leading Indian technocrat and DG, Council of Scientific and Industrial Research (CSIR) Dr RA Mashelkar. Dr Mashelkar is the key Indian interlocutor in the Indo-US high tech dialogue. "India's real advantage is not just cost but the value offered. That is why over 100 of the Fortune 500 companies have set up their research and development centers in India in recent years," he told the Bangalore gathering. The American cooperation in life sciences was reiterated by former US ambassador to India, Thomas Pickering, a vice president of Boeing Corp. and the private sector chairman of HTCG. "India's proven capabilities in biotechnology makes the country a promising future destination. India should be quick in integrating into the global drug production and new drug discovery networks," Pickering advised. Top policy makers, industry representatives and CEOs of Indian and American companies participated in three parallel sessions on the priority areas. They thrashed out the various issues in the smooth transfer of technologies between India and the US. The dialogue process has gained momentum in 2003, indicated by the active involvement of the key movers from both sides, two times this years. Industry leaders from both sides expect the removal of various irritants on priority basis so that they could look forward to a bumps-free ride on the Indo-US High Tech Corridor. N Suresh 12 steps to biotech prosperity After a three-hour intensive dialogue between representatives of Indian and US Life Sciences sectors, as part of the Indo-US High Technology Cooperation Group (HTCG), in Bangalore on November 19, 2003, a set of 12 recommendations were finalized. India's leading business chambers, FICCI, coordinated the dialogue. While Bharat Biotech International chairman, Dr Krishna M Ella, chaired the discussion, the US side was led by Suresh Patil, chairman, Hawaii Biotech. BioSpectrum was part of the team that compiled the recommendations and participated actively in the discussions. These 12 issues were taken up for detailed discussions between the top officials of both India and the US in New Delhi on November 20. In due course, most of these recommendations will eventually get implemented, paving the way for the growth of the biotech cooperation between both the countries. 1. Adherence to all Intellectual Property Rights agreements including the modified Indian Patents Act incorporating product patents in pharma and agriculture 2. The US government should remove unnecessary restrictions and delays caused to Indian exports of biotech products which fall in the dual use categoryâ€”civilian commercial and defense use 3. India could consider adapting the US Department of Agriculture (USDA) fund sharing mechanism 4. India should harmonize all the legislation related to the introduction of genetically-modified(GM) products â€“such as Seeds Act, Environment Protection Act and Prevention of Food Adulteration Act and Patents Act 5. A fast track mechanism for clearance of biotechnology products for commercialization, clinical trials 6. US and India should take up mutual accreditation of professional qualifications to avoid duplication of various mandatory product tests 7. India should either abolish or enhance the eight percent upper limit imposed on payment of technology import fee 8. India's Patents Act should be amended to include "gene constructs" under the permitted categories to avoid hassles related to interpretation by customs 9. India should set up a "single window" clearance for biopharma and GM products 10.Some clarifications related to some of the "draconian" provisions in the Biodiversity Act which hamper the handling of biotechnology products 11.India should provide for data exclusivity to clinical trials and not permit use of the same data to introduce generic drugs in the same category 12.Streamlining of the customs clearance process for the import of biotech materials required for research Its "Bioactivity" in MaharashtraPatangrao Kadam, the Minister for Industries, government of Maharashtra launched the Confederation of Indian Industry (CII)'s biotech initiatives by inaugurating the Maharashtra Maha BioYatra this year. This is a network forum acting as communication and marketing network for the state's bioscience community, started last year in August. View of the exhibition on PharmaExpo 2003 New age biotechnology The CII in association with the government of Maharashtra, Maharashtra Industrial Development Corporation and International Biotech Park organized the second in series of the Biotech Day on the theme "New Age Biotechnology in Maharashtra" on Nov 14. The conference was inaugurated by the industry minister Patangrao Kadam. Speaking to BioSpectrum Kadam informed that the state government would create a biotech fund for the benefit of small and medium entrepreneurs. There were five sessions covering diverse topics but it seemed difficult for the audience to digest it all. The hall was packed with audience when the conference started. As the day progressed the crowd became thinner and thinner. In the final session of the day, on clinical research organizations, there were about 20-25 people left in the audience. But surprisingly, there were a good number of people present for the same topic at the PharmaExpo, again, organized by CII, at another place on Nov 15. CII made efforts in organizing the event. But at the end of the day who are the gainers? Although there are many members both from industry and scientific community in the biotech task force and biotech commission constituted by government of Maharashtra their participation in the conference organized by the state government on Maharashtra biotech day was not seen. This is not a good trend. The organizers must take it seriously by seeking the suggestions of the members and involving them in the activities. Their participation definitely will have its impact on the event. Unless this happens the state may see sluggish progress in bringing awareness about the opportunities in biotechnology and the latest happenings in this knowledge based industry. The event featured speakers from India and abroad but due to paucity of time the speakers were asked to complete their presentations in the middle. To create awareness about the topics the speakers should be given enough time. There should be some time for discussions too. Otherwise the audience will end up getting more confused. Similar situations were seen even at the three-day Bangalore Bio 2003 and at Vibrant Gujarat, the Pharma Biotech summit held in Ahmedabad last month. The organizers have to look into the reasons for the poor attendance, otherwise these summits and conferences will be of no use. Herbal World-2003 In addition, Prabodhan, a charitable trust in association with Khadi and Village Industries organized a two-day seminar on "alternative and traditional medicines, nutraceuticals and cosmetics of herbal origin" and a four-day exhibition (Nov 13-16) on 'Herbal World 2003'. The exhibition attracted many herbal medicine companies like Zandu, Bhaidyanath, Charak Health Care, etc. and a few agri biotech firms like Alpine Biotech, Nirmal AyurLife, etc. to showcase their herbal products. Even nurseries and many ayurvedic colleges participated in the exhibition. The exhibition attracted good crowd. PharmaExpoâ€“2003 PharmaExpoâ€“2003, a two-day international conference on India Pharma Incâ€”New Horizons was also held in Mumbai in mid November. It was organized by CII. As many as five sessions including a panel discussion on "evolving Indian pharmaceutical industry: what would be the post 2005 scenario?" were arranged as a part of the conference. The sessions covered the subject of regulatory procedures and standards, which is a very apt topic for discussion at this time, as the pharma industry has to implement/upgrade to Schedule M. The other topics covered at the conference were the IP watershed for Indian pharma industry and emerging trends and opportunities in clinical trials and information management for pharmaceutical industry. Representatives from companies like Wockhardt, Well Quest, Infosys Technologies, etc. made presentations. The conference saw representatives from over 40 pharma companies. At the exhibition organized by PharmaExpo, apart from distributors and suppliers to pharma companies, MIDC and Genome Valley, Hyderabad attracted good industry crowd to their stalls. Most of the companies received quite a number of enquiries and were satisfied with the turn up of the industry people. On Nov 20, Assocham (Associated Chambers of Commerce and Industry of India), Organization of Pharmaceutical Producers of India, Indian Merchants Chamber, CropLife, ABLE (Association of Biotechnology Led Enterprises) and PhRMA (Pharmaceutical Research and Manufacturers of America) came together and jointly organized a day's seminar on "India: The new emerging R&D hub for knowledge based industries". The speakers at the seminar covered topics on pharma, biotech, agrochem and IT sectors. After a gap of a few months, activities have picked up in biopharma, biotech and agri biotech areas. This is good sign. With good economic growth and good monsoon this season, companies are investing in R&D activities. To support their initiatives organizations are arranging conferences and seminars, which will prove beneficial for the industry. In continuation with these programs, University of Pune, the bioscience division of IIT, Mumbai, Small Industries Service Institute are planning to organize programs in bioinformatics, biomaterials and biotechnology in the next few weeks. Narayan Kulkarni Centralised licensing in drug manufacturing: future scenarioThe pharma and healthcare sectors hold unique positions among the growing segments of the Indian industry. The healthcare market of India, as of today, is worth Rs 100,000 crore and is expected to reach Rs 200,000 crore in the next three years. But there is a common concern among the industry over the existing pharmaceutical regulatory system. With the increased thrust on pharma, now everyone is talking about growth and accepting more challenges. But the question is how can this be achieved? Most of the big players of the pharma industry are of the opinion that if the Indian drug regulatory scenario becomes strong, fast and independent, then this industry will grow at an accelerated speed. In this regard, the Mashelkar committee has prepared a comprehensive road map for revamping the Indian drug regulatory system. It has suggested a three-phase switch over from the current state licensing system to a central licensing regime for drug manufacturing facilities across the country. If the Mashelkar committee recommendations have their way, then a Central Drug Administration (CDA) will take over the responsibility of issuing licenses to drug manufacturing facilities of 19 states during 2004-05, where the pharma industry has a bare minimum presence (5 percent). It is also expected that centralized licensing in most other states will be implemented from 2006 onwards. States like Andhra Pradesh, Goa, Gujarat, Karnataka, Maharashtra, Tamil Nadu and West Bengal where almost 75 percent of the drug manufacturing units are located, will be the last to be under CDA control as the authority needs to substantially strengthen its infrastructure and manpower for effective discharge of responsibilities in these states. Appreciating the Mashelkar Committee's recommendation for centralized drug administration, JVR Prasada Rao, secretary, department of health and family welfare said, "the centralization will also give tremendous boost to the image of Indian drug industry. A drug regulatory system with centralized control would only help to streamline the licensing functions and thereby improving the quality standards in the Indian pharma industry." The committee is yet to suggest the licensing functions of the remaining Category II states, where 20 percent of manufacturing activity has concentrated which can be taken over by the proposed CDA from 2005 onwards. The states that come under this category include Bihar, Delhi, Haryana, Kerala, Madhya Pradesh, Orissa, Punjab, Rajasthan and Uttar Pradesh. Pharma majors like DS Brar, CEO and MD, Ranbaxy stated, "India has lot of potential in pharma and bio-pharma segments of the industry. We can achieve success in this segment if the system gets more effective and speedy." Similar statements have come from other companies like Eli Lilly. "The industry requires the single-window outlet for drug regulatory issues. It is not a easy job to do but the government should start taking initiatives in that direction," commented Rajiv Gulati, MD and chairman Eli Lilly. Meanwhile, in a recent development, the Drugs Controller General of India (DCGI) has announced the approval of 24 new drugs this current year. While Sun Pharma got four of their applications cleared, it was three each for Cipla and Glenmark. Microlabs, Ranbaxy and Hetero received two new drug approvals each during the period until October 2003. On import registrations front, the DCGI has approved 61 bulk drugs and 28 formulations during the last one-month (Sep 15 to Oct 15). While 22 of the bulk drugs cleared are to be imported from France, 15 are from China. Bulk drugs from Korea and Switzerland have also been cleared during the period. Looking at the current developments, it can be assumed that the future of this segment of the pharma industry is bright and the government has taken the responsibilities to facilitate its growth. But all this depends on the competitiveness of the industry and attentiveness from the government's side. We can only hope that both these factors will lead to further growth of the industry. Faiz Askari   ]]> <![CDATA[GEAC under fire]]> https://biospectrumindia.com/news/95/2085/geac-under-fire.html https://biospectrumindia.com/news/95/2085/geac-under-fire.html Thu, 11 Dec 2003 18:30:00 +0530 A key biotechnology regulator, the Genetic Engineering Approval Committee (GEAC), has been a topic of animated discussion at various industry forums for quite some time. Particularly, this committee, which is part of the Ministry of Environment and Forests (MoEF), has been the object of stringent criticism mainly for its lack of expertise and its nebulous structure. Many of its recent decisions have come under the industry scanner for lack of any direction. The November 27 decision of the committee to ask for an inquiry into the manufacturing of a recombinant streptokinase (a blood-clot busting drug) by a domestic biotech icon, Shantha Biotechnics, Hyderabad, and the threat to take action against the company has added fuel to the fire against the regulator. In this case, most experts feel that GEAC has overstepped its authority. And it has poached into the domain of another regulator, the Drug Controller General of India (DCGI), the agency which authorizes clinical trials of all drugs prior to commercial use. In Shantha's case, the DCGI has apparently evaluated the relevant data and given the nod for limited manufacturing and trials of streptokinase. As the drug involves the use of recombinant techniques, in due course, Shantha's application would have landed up before GEAC for final approval This issue has brought the focus again on the competence of GEAC as a specialized regulator for this highly sophisticated technology sector. The first thing that strikes any observer is the fact that GEAC has no defined structure. Most other regulatory agencies in the country have a well-defined structure unlike the GEAC whose head is there in an ex-officio capacity. No wonder this agency has had at least five temporary heads in 2003 alone. The committee is entirely made up of officials drawn from various government agencies and it thus lacks continuity in taking up its multi-speciality role. Isn't it time a more permanent structure is put in place for this key regulatory agency? This is certainly the question uppermost on the minds of almost all the players in the biotechnology sector. A former chief of GEAC had stressed the need to bring in the views of various stakeholders into the committee's decision making process at least six months back. Now there are signs that this may actually become a reality in the next few months as the agency is planning to hold widespread consultations with the public across many cities, make available as much data as possible to the public for scrutiny and usher in transparent procedures. The realization has dawned among policy makers that this was one of the glaring gap in its functioning. The process should actually go beyond these routine administrative steps. There should be a national debate on the structure of GEAC and it should be immediately given concrete structure with a widely respected biotechnology expert as the head and a full-fledged team of multi-disciplinary experts with requisite autonomy to keep close tabs on a technology sector that can cause immense harm or contribute immense benefits to the human kind if directed properly.   ]]> <![CDATA[Fun & joy of science]]> https://biospectrumindia.com/news/95/2336/fun-joy-of-science.html https://biospectrumindia.com/news/95/2336/fun-joy-of-science.html Thu, 11 Dec 2003 18:27:00 +0530 James Watson felt sure that it was going to be possible to discover the molecular nature of the gene and worked hard at it, even to such an extent that he was fired from the Rockefeller Fellowship that he had. Einstein has been quoted as saying that, when he was 15 years old, he asked himself what would the world look like if [he] were moving with the velocity of light. To attack that problem he inquired into the nature of equations that had been set up for electro-magnetic fieldsâ€”Maxwell's equations. It was the study of Maxwell's equations that led Einstein to his special theory of relativity. Einstein started thinking about the problem when he was 15; he was 25 when he formulated the special relativity equations. RA Mashelkar Linus Pauling worked on a problem for 10 years too before finding the solution. It is interesting to hear a story from Linus Pauling himself. Often my original ideas have come as the result of training my unconscious mind to think about a problem. I gave as an example the one on the theory of general anesthesia. I was in Boston as a member of the scientific advisory board of Massachusetts General Hospital in 1952, and this board was lectured by the professor of anesthesiology at Harvard-Henry K Beecher. Beecher said something that I hadn't knownâ€”that the noble gas xenon can act as a general anesthetic agent. So I said to my son (who was studying medicine). "How do you think xenon can serve as a general anesthetic agent, since xenon doesn't form any compounds in the human body? It must be some sort of a physical action. I don't understand it." I thought about it day after day for several days. In the evening when I would go to bed, I would lie there and think about the problem â€¦ After a while I stopped that. Then, seven years later, I was reading a scientific paper on crystal structure, and I said to myself, I understand anesthesia. I worked for about a year gathering data, and then I published my paper on "A molecular theory of general anesthesia." So I had trained my unconscious mind to keep this problem in view, and whenever any new thought entered my head, any new piece of information, I would connect it up with that problem to see if there was any connection â€¦ Risk taking rewards Let me explain that risk taking is the key and therefore, in scientific research, there should be no place for those who preserve the systems in a pre-fabricated and unaltered way. A friend of mine, who is a CEO of a company from abroad, once said, "We do not shoot people, who make mistakes. We shoot people who do not take risks. What do you do?" I said, "In India, we shoot people, who take risks!" I believe this is true. The most risk-averse are government laboratories. In fact, it is more often than not that such institutions are run by rules and regulations than by objectives. The system of S&T audit in our laboratories needs an urgent relook. When we fund "futuristic research" we are funding risks too. But many times, the view of the future is taken by extrapolating the present. This does not always work out. Indeed the ability to speculate on the future is more difficult now than ever before. Even when the pace of change was nowhere near what it is today, the forecasts made by some of the brightest minds went so wrong. Let me recall one such effort. In 1937, the National Academy of Science (USA) organized a study aimed at predicting breakthroughs of the future. Several wise statements about agriculture, synthetic rubber etc. were made. They were essentially based on an imaginative extrapolation of the present. But it missed all the things that happened. It was amusing that in their predication, there was no mention of nuclear energy, no antibiotic (although it was just eight years after Fleming), no jet aircraft, no rocketry, nor any use of space! And these are precisely the technologies that have dominated our lives in the last few decades. I, therefore, feel that we must respect judgments of those, who are capable of exceptional flights of fancy, rather than only relying on those, who are experts in narrow areas of specialization. There is so much to learn from the innovative firms around the world as far as supporting risky research is concerned. Some firms set up goals that stretch your mind. For example, Du Pont has defined a set of "unreachable goals" like immortal polymers, zero waste processes, elastic coatings as hard as diamonds, elastomers as strong as steel, materials that repair themselves, chemical plants that are run by a single chip and coatings that change color on demand. These may sound unrealistic but they are publicized widely and enthusiastically supported. Intel motivates its innovations by saying "double machine performance at every price point every year". Unfortunately, I have to cite only these examples from the western world, since I am not aware of an Indian firm, who supports risks in the way these companies do. We must also understand that the challenge is not only that of funding risky ideas, but also spotting and funding mavericks, who have the potential to create breakthroughs. Such unusual innovators refuse to preserve status quo. Whereas standard science management practices tend to avoid conflicts, such people create conflicts. They bring in unusual spontaneity and exceptionality to the table. Their incentives are personal and emotional. They are not institutional or financial. Such innovators are sometimes extremely intense. Greet innovators like Carother, who developed the world's first synthetic fiber nylon, committed suicide. Diesel, who invented diesel engine, also committed suicide. Managing such intense and creative people requires a subtle understanding of the pain of creation that such people undergo day in and day out. Finally, science is an exploration of the nature of reality, both inside and outside us. The emphasis here is on things, which are quantifiable and measurable and on theories, which can be tested and demonstrated and facts, which can be observed and verified by others. Imagination plays a vital part in both science and art, but in science it has certain constraints. As Feynman said, "whatever we are allowed to imagine in science has to be consistent with everything else that we know. The problem of creating something which is new, but which is consistent with everything which has been seen before, is one of extreme difficulty". At the same time, the difficulty with science is often not with the new ideas, but in escaping the old ones. A certain amount of "irreverence" is essential for creative pursuit in science. I believe that if we promote that irreverence in Indian science, by change of personal attitudes, change of funding patterns, creating new organizational values, creating that extra space for risk taking, respecting the occasional mavericks and rewarding the risk takers, then not only will the fun and joy of doing science will increase, but also Indian science will make that difference, that "much awaited" difference. RA Mashelkar         ]]> <![CDATA[BioAgri attracts domain specialists]]> https://biospectrumindia.com/news/95/7791/bioagri-attracts-domain-specialists.html https://biospectrumindia.com/news/95/7791/bioagri-attracts-domain-specialists.html Thu, 11 Dec 2003 18:02:00 +0530 The thrust on the bioagri segment has led to the establishment of new companies. Many traditional seed companies have also branched out in agricultural biotechnology. This industry has requirements in the areas of research, technical support and marketing and most of the companies are both into product development and its marketing. "As agriculture is a dominant sector in India, we see a huge opportunity. The surge in opportunity will be in improving agricultural productivity," said Dr Villoo Morawala-Patell, founder and CEO, Avestha Gengraine Technologies, a fully integrated biotechnology and bioinformatics company. "BioAgri will be a very strong sector in the years to come, in view of the Indian government's decision to open the market for biotech crops," said Dipankar Bandyopadhyay, HR Manager, Monsanto India. Monsanto, an integrated agri solutions provider, has introduced the country's first GM cropâ€”Bollguard (Bt cotton). India offers a huge market for agribiotech products as more than half of the country's population depends on agriculture. "Indian market is big, value lies in making products suited to Indian agronomy and markets," commented Dr Gautham Nadig, director, Metahelix Life Sciences, a young agribiotech company. Depending on the domain specialization of the company, the job categories vary and accordingly the qualifications required also differ. Morawala-Patell said, "the different job categories at Avesthagen are technical, scientific, business development, administration, finance, legal, PR, clinical, product development and software programmers." She added, "we have a separate bioagri segment with state of the art laboratory and high throughput technology to cater to various R&D services. We recruit people with PhD and MSc for the science aspect of business and MBA's for business development and other management related positions, LLB's and also people specializing in patent law." Camson Bio Technologies, a Bangalore based agribiotech company, is into research, development and marketing of biopesticides and seeds. Dhirendra Kumar, CEO, Camson said, "the minimum qualification that we look for is BSc agriculture coupled with a dynamic and enthusiastic approach. A basic knowledge of crops, diseases, etc is essential for this field. For marketing MBA's are preferred." Nunhems seeds, a subsidiary of Nunza BVâ€”a Netherlands based vegetable seed company, is involved in research, production and marketing of seeds throughout India. The company has a separate biotech division to address the emerging opportunities in the agri sector and employs molecular biologists and tissue culturists. "We look for MSc and PhD degree holders in molecular biology, biotechnology, tissue culture and their main responsibility is molecular analysis of the material of both lab and field studies and maintenance of tissue culture plants," explained Dr Arvind Kapur, MD, Nunhems seeds. "The candidates should have thorough domain knowledge and practical skills in the areas of molecular biology, biochemistry, genomics, proteomics, metabolomics and bioinformatics," said Dr Villoo Patell, CEO, Avesthagen. Companies like Indo-American Hybrid Seeds (IAHS) and Prabhat Agri Biotech have independent biotech divisions, which employs scientists and technical assistants. The companies look out for candidates having strong subject knowledge, analytical and practical skills, focussed approach and good communication ability. "The candidates should have thorough domain knowledge and practical skills in the areas of molecular biology, biochemistry, genomics, proteomics, metabolomics and bioinformatics. They should have strong ability to manage multiple projects independently and experience in managing and developing technical staff and building a highly motivated team," elaborated Morawala-Patell. "Keen product development mentality, being able to make sound management decisions, keeping tight time lines and quickly move projects forward, proficient in the use of computers, particularly in the use of application software for various instruments, high energy and enthusiasm and positive 'can do' attitude are some of the other requirements," she added Monsanto broadly focuses on three areasâ€“agricultural chemicals like herbicides, hybrid seeds and biotech/GM crops. The job categories in the company are sales, product development, marketing (brand management), breeders, hybrid seeds production and research and development. "For the R&D division doctorates and post doctorates with domain specialization and relevant experience are required. They should have a very high level of technical competence and analytical bent of mind. In the sales division there is intake of candidates with diverse qualifications like MBA, MSc Agri, BCom, PhD, etc. Basically they should have the core ability to understand and explain to the farmers about the merits of the products. Experienced candidates (2-3 years of relevant experience even from a non-agri FMCG background) do have an advantage, but we also take in freshers. Our main focus is not on experience but on the potential of the candidates to deliver and do the job. We focus on a diverse profile," said Dipankar Bandyopadhyay, Monsanto India. "We focus on excellence, sound communication and analyzing skills and strong knowledge of the market. The essential selection criteria considered are the excellence in educational qualifications, extracurricular activities, experience and key achievements in their fields," he added. Dr. PS Rao, VP-Biotech, IAHS said, "we do employ postgraduate/PhD degree holders in biotechnology. If the candidate is strong in basics of plant sciences and is able to communicate well, then he has a better chance. This of course includes basic qualification/experience that is desirable. We look for individuals with commitment, who can use biotech tools to enhance crop productivity." "We look for MSc and PhD degree holders in molecular biology, biotechnology, tissue culture and their main responsibility is molecular analysis of the material of both lab and field studies and maintenance of tissue culture plants," said Dr Arvind Kapur, MD, Nunhems seeds. Metahelix Life Sciences, which focuses on trait development, functional genomics and marker-assisted selection, has research technicians and scientists specializing in the areas of plant molecular biology, functional genomics and plant breeding. Dr Gautham Nadig, Director, Metahelix said, "we look for MSc, PhDs in plant breeding, genetics, seed technology and plant molecular biology. The job responsibilities are to plan out experiments, execute them, manage people, work in a team and deliver on time, high quality results." "Though it is not essential to have experience but a strong academic record and a clear understanding of the basic science is required," he added. But experience is an important selection criterion in some companies as Dr Sateesh Kumar of Prabhat Agri opines, "candidates are selected after personal interviews and experience gives a definite selection edge as bioagri requires more technical and practical lab-oriented skills apart from intelligence". Inviting resumes, screening, short-listing and then interviews is the standard procedure of selection. "At Monsanto recruitment takes place through consultants or through the career section on Monsanto India's website where interested candidates can post their resumes. These resumes are screened and shortlisted candidates have to appear for two rounds of interviews. But in case there is recruitment on a large scale then, in addition, there is a general discussion round also. Lastly there is a reference check," elaborated Dipankar, Monsanto India. Dr Rao, IAHS said, "there is an HRD division and the candidates are taken in through a selection committee of experts in the respective field." Campus recruitment is the norm in some companies. As Morawala-Patell said, "We are always on the look out for quality people depending on the projects executed and domain knowledge of an individual. Since biotechnology as a sector has close links with academia, campus recruitment is one of the avenues to find aspirants willing to work in the biotech industry." "Campus recruitment is done and some of the institutes where we go are Gandhi Krushi Vighnana Kendra (GKVK), Bangalore, MANAGE, Hyderbad and GB Pant Agricultural University, Uttaranchal," informed Dhirendra Kumar of Camson. Constant upgradation of employee skills and the awareness of the latest developments is facilitated by the companies through a range of training programs. "Training is provided as and when required. For example in areas such as commercial micropropagation the candidates are put on training for a period of 6-12 months within the organization," said Dr Rao, IAHS. "There are regular product training programs in the segments of agri chemicals, hybrid seeds and GM crops. We have Monsanto Advanced Sales Training (MAST) for the sales and marketing division, " said Dipankar Bandyopadhyay, Monsanto. To strengthen the academic-industry relationship many companies conduct training programs/workshops for students. Like IAHS offer technical training in advanced methods of plant cell and tissue culture and r-DNA technology. Dhirendra Kumar, Camson said, "the company offers programs for completion of part time masters dissertation and provides technical education and management training programs." "Students from various colleges/universities in India and abroad come to Avesthagen to do their projects. We also have a tie-up with University of Mysore, where in students can do their PhD at Avesthagen and degree will be awarded by University of Mysore," said Morawala- Patell. As most of the agribiotech companies and the entire segment as such is young, hence the growth potential for the employees is high. In most of the companies the size of the core work team ranges from about 35 to 100. Taking the entire workforce into consideration (research, technical support and marketing) the ratio of manpower to womenpower is 8:1. But if the research section is seen alone then the ratio can be as high as 1:1. The salaries depend on experience, skills, quality and availability and it varies between Rs 6,000 to 50,000 per month. Many companies like Avesthagen, Camson, Metahelix, etc have plans for recruitment and require candidates for their R&D division. In the near future agribiotech will no longer be a discrete sector but will become an extension of the existing agricultural system and the industry will see a slow shift from chemical to gene- based solutions in agriculture. Rolly Dureha ]]> <![CDATA[Allergen to acquire Oculex for $230 M]]> https://biospectrumindia.com/news/95/4467/allergen-to-acquire-oculex-for-230-m.html https://biospectrumindia.com/news/95/4467/allergen-to-acquire-oculex-for-230-m.html Thu, 13 Nov 2003 11:40:00 +0530 Allergan Inc. entered into a definitive merger agreement to acquire Oculex Pharmaceuticals Inc., subject to certain conditions, including Federal Trade Commission and Oculex shareholder approval. Allergan will pay approximately $230 million for the Oculex business in an all cash transaction. Allergan expects the acquisition to be completed by the end of November 2003. Oculex is a privately held company developing innovative, therapeutic products for the treatment of major, sight-threatening diseases of the eye. Its investigational product, Posurdex, is a proprietary, biodegradable, sustained release implant that delivers dexamethasone to the targeted disease site at the back of the eye. Phase 2 clinical trials for Posurdex presented earlier this year showed promising results. Allergan intends to initiate Phase 3 clinical trials for it in early 2004. Allergan Inc., with headquarters in Irvine, California, is a technology-driven, global health care company providing eye care and specialty pharmaceutical products worldwide. Baltimore VC plans $1 billion new fund New Enterprise Associates (NEA), a Baltimore-based VC firm, plans to set up $1 billion fund for health care and life sciences investments. NEA had a strong portfolio towards technology and communications opportunities and wants to diversify. Its tenth fund closed September 2000 was $2.2 billion in size. The firm, founded in 1978, has $5 billion in capital under management. NEA invests at all stages, but it is more interested in providing start-up capital, or the first outside funds a company raises. By becoming involved at an early stage, it feels it is able to add value and provide guidance through the critical early stages of a company's life. ChemoCentryx gets $14M NIH grant ChemoCentryx has got a $14 million grant to develop first-in-class immune modulatory agents targeting chemokine receptors for the prevention and treatment of infectious diseases that may be caused by biological warfare pathogens from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health. The grant will support drug discovery efforts including small molecule screening, medicinal chemistry optimization and pre-clinical development. This research is intended to harness the unique power of the chemokine system, a primary regulator of the migration of immune cells throughout the body. ChemoCentryx's approach is to discover and develop orally bioavailable small molecules to block or stimulate a given chemokine receptor. This grant was made under the NIAID's cooperative research program for the development of new vaccines, adjuvants, therapeutics, immunothera-peutics or diagnostics focused on NIAID category A-C biodefense pathogens. ChemoCentryx discovers, develops and commercializes small molecule medicines for autoimmune diseases, inflammatory disorders, cancer and infectious disease. Its Traficet-EN, orally active drug for inflammatory bowel disease, will enter clinical trials in 2003. Other products include an orally active development candidate for rheumatoid arthritis and multiple sclerosis, and emerging drug candidates for cancer and cardiopulmonary inflammation. Biotech cos go public Almost after a gap of 12-18 months, biotech firms went public this October. There are about 20 odd biotech companies waiting to go public now and raise close to $1 billion according to some analysts. Genitope Inc. went public offering 3,700,000 shares of its common stock at $9 per share on the Nasdaq. Genitope has granted the underwriters the right to purchase up to an additional 555,000 shares of common stock to cover over allotments, if any. Genitope is a biotechnology company focused on the research and development of novel immunotherapies for the treatment of cancer. Its lead product candidate, MyVax, personalized immunotherapy, is a patient-specific active immunotherapy based on the unique genetic makeup of a patient's tumor and is designed to activate the patient's immune system to identify and attack cancer cells. Genitope was launched in 1996 and still has no product on the market. It is in the final phase of testing a vaccine to treat non-Hodgkin's lymphoma. It produces a personalized vaccine for each patient and this was built on technology developed at Stanford University. CancerVax Corp., a biopharma company focused on cancer therapies, began trading on the Nasdaq hoping to raise up to $115 million through its IPO. It ended up with $72 million after pricing six million shares at $12 per share. The company had raised over $125 million in venture funding since its 2000 inception, including a $41.4 million Series C round in August at a post-money valuation of approximately $174 million from investors like Forward Ventures, Vector Fund Management, JPMorgan Partners and WestLB Asset Management. Each Series C share was converted at a price of $8.84 per share at the time of the IPO. Its vaccine research and development programs are focused on obtaining approval of the Canvaxin therapeutic vaccine for the treatment of melanoma and colon cancer. Myogen Inc., a biopharmaceutical company focused on the discovery, development and commercialization of small molecule therapeutics for the treatment of cardiovascular disease, announced the pricing of its IPO of 5,000,000 shares of its common stock at the public offering price of $14.00 per share, before underwriting discounts and commissions. It had raised a total of $127.3 million in venture capital financing (plus $5.3 million worth of term loans), most of which came from New Enterprise Associates (28.5 percent pre-IPO ownership, 23 percent post-IPO ownership), JPMorgan Partners (20.4 percent pre-IPO, 16.4 percent post), InterWest Partners (13 percent pre-IPO, 10.4 percent post-IPO), Perseus-Soros Biopharmaceutical Fund (8.1 percent pre-IPO, 6.5 percent post-IPO) and Sequel Venture Partners (6.3 percent pre-IPO, 5 percent post-IPO). ]]> <![CDATA[Biotech attracted more venture capital than any other industry in Q3]]> https://biospectrumindia.com/news/95/1978/biotech-attracted-more-venture-capital-than-any-other-industry-in-q3.html https://biospectrumindia.com/news/95/1978/biotech-attracted-more-venture-capital-than-any-other-industry-in-q3.html Thu, 13 Nov 2003 11:39:00 +0530 According to the Pricewaterhouse-Coopers, Thomson Venture Economics, and National Venture Capital Association MoneyTree Survey, venture capitalists invested $4.2 billion in 667 entrepreneurial companies in the third quarter of 2003. The third quarter survey results represent a slight decline of 8 percent of dollars invested and 5 percent of number of deals compared to the second quarter, but represent a slight uptick from the first quarter of this year. For five consecutive quarters, beginning with the third quarter of 2002, venture capitalists have invested in the range of $4 billion per quarter, sustaining a healthy pace of investing in new and existing portfolio companies. For the first time in seven years, biotechnology was the number one industry with $873 million, displacing software as the leading category. Investments in biotechnology companies increased 31 percent from the previous quarter and 88 percent from a year ago. "The broader Life Sciences sector, which includes biotechnology and medical devices & equipment totaled $1.24 billion, an impressive 30 percent of all dollars invested, clearly demonstrating that venture capitalists believe that the innovation occurring in these fields will translate into profitable new products and services in the future," notes the survey. The software industry was down 11 percent compared to the previous quarter, dropping it into the number two position with 160 companies receiving $819 million. Telecom with $492 million remained in third place and medical devices with $376 million followed in fourth. The ranking of industries receiving first-time venture dollars varied notably from the overall industry rankings. Software companies lead with 38 companies attracting $138 million. Biotechnology was second with 16 companies and $72 million. Medical devices followed with 15 companies receiving $54 million. Biotechnology VC Deals in Q3 Company Amount ($m) Deal share Acorda Therapeutics Inc. 55 8.32% Rib-X Pharmaceuticals Inc. 51 7.68% Santarus Inc. 51 7.68% BioMedicines Inc. 43 6.48% Nanosys Inc. 38 5.72% QUATRx Pharmaceuticals Company 28 4.22% ActivBiotics Inc. (FKA: Merlin Technologies, Inc.) 26 3.98% US Genomics Inc. 25 3.77% Xenogen Corp. 22 3.31% Nanostream Inc. 22 3.25% Cytokinetics Inc. 22 3.24% Affymax Inc. 20 3.01% ESP Pharma Inc. 20 3.01% Momenta Pharmaceuticals (FKA: Mimeon, Inc.) 19 2.86% MetaPhore Pharmaceuticals 16 2.41% Endocyte 16 2.33% Sention Inc. (FKA: Nemogen, Inc.; Cognetics) 15 2.29% Concurrent Pharmaceuticals Inc. 14 2.11% Phenomix Corp. 14 2.03% Hydro Med Sciences Inc. (AKA: HMS, Inc.) 12 1.81% Favrille Inc. 11 1.60% Ambion Inc. 11 1.58% Cellerant Therapeutics Inc. 10 1.51% Cohesive Technologies Inc. 8 1.20% Kemia Inc. 8 1.19% RxStrategies Inc. 8 1.17% Integrity Pharmaceuticals Inc. 7 1.00% Anawah (FKA: Tilligen Inc.) 6 0.90% Chlorogen Inc. 6 0.83% Aperon Biosystems 5 0.69% Regenecor Inc. 5 0.68% Hawaii Biotech Inc. 4 0.66% GlycoMimetics Inc. (AKA: GMI) 4 0.65% Kalobios Inc. 4 0.60% Triosyn Corporation 4 0.60% TransForm Pharmaceuticals Inc. 3 0.48% Acadia Pharmaceuticals Inc. 3 0.45% Fluorous Technologies Inc. 3 0.45% Amicus Therapeutics Inc. 3 0.45% Advanced BioNutrition Corporation 3 0.38% Jazz Pharmaceuticals Inc. 2 0.32% Athenix Corporation 2 0.30% CyThera Inc. 2 0.30% Vitra Biosciences Inc. (FKA: Virtual Arrays Inc.) 2 0.23% Undisclosed Company 1 0.22% Hepaticus Inc. 1 0.21% Imaging Therapeutics Inc. (FKA; OsteoNet.com Inc.) 1 0.20% Q-RNA (AKA: In Vitro Diagnostics Inc.) 1 0.20% Angiosyn Inc. 1 0.15% Guava Technologies 1 0.15% GlobeImmune Inc. 1 0.15% AppTec Laboratory Services 1 0.15% PhysioGenix Inc. 1 0.13% ZuChem 1 0.13% Bioform 1 0.08% Integral Molecular 1 0.08% Spliceomix 1 0.08% Vax Innate Corporation 1 0.08% RetinaPharma Technologies 0 0.07% eNOS Pharmaceuticals Inc. 0 0.06% Analgesix 0 0.06% Orexigen Therapeutics Inc. 0 0.05% Othera Pharmaceuticals Inc. 0 0.02% Phoenix S&T 0 0.01% â€¢ Average $ per deal: $9,623,333 â€¢ Deals: 69 â€¢ Source: The MoneyTree Survey ]]> <![CDATA[GE acquires Amersham for $9.5 billion ...]]> https://biospectrumindia.com/news/95/7819/ge-acquires-amersham-for-9-5-billion-.html https://biospectrumindia.com/news/95/7819/ge-acquires-amersham-for-9-5-billion-.html Thu, 13 Nov 2003 11:28:00 +0530 On 10 October 2003, when General Electric Co. and Amersham PLC announced that they have reached an agreement on the terms of an all-stock transaction, a new beginning was unleashed. As per the deal, GE will acquire all the outstanding shares of Amersham at 800 pence and the diluted share capital of Amersham at approximately $9.5 billion. The announcement is important not only for the size of the deal but beyond that. The more far-reaching outcome of the deal is that GE will have an edge in harnessing the use of genetics in treating patients. The deal puts GE in direct competition with diagnostic and drug firms like Roche and Abbott Laboratories. Amersham chief Sir William Castell's vision for GE Healthcare Technologies My vision for GE Healthcare Technologies is that we are the leading diagnostic company. That we will pioneer a new chapter in medicine. That we will integrate all diagnostic information in front of the referring physician in such a way as he can embrace not only today's diagnostics, but tomorrow's. Tomorrow's includes genetic understanding both for predisposition to disease and genetic variation. The ability to segment customers based on the efficacy or lack of side effects of drugs - and that's called pharmacogenomics - and leading to a better quality of life. One where we move from yesterday's paradigm of medicine, which is largely empirical â€“ "I feel ill; what's the diagnosis?" - to a medicine which predicts disease, that identifies disease before it becomes clinically important, that allows us to better identify therapy and allows us to make sure that therapy is working. So it's a transformation. It will deliver a better quality of life. It will deliver better cost effectiveness for the health care challenges, the cost challenges, around the world and it is a vision that is almost a reality today. It's following on very quickly from the rapid developments in IT and the rapid understanding of biology that descends from the sequencing of the human genome and the better understanding of proteins in the body. It's the most exciting age in terms of biological science. I have the privilege of, in the future, leading the leading diagnostic company in realising the benefits of high technology for our consumers and customers worldwide.   Does this buy out really matter? IBM Lifescience's prediction on future of pharma reads as: "In 2010, the pharmaceutical industry (pharma) will not only make white powders, it will sell a variety of products and therapeutic healthcare packages that include diagnostic tests, drugs and monitoring devices and mechanisms, as well as a wide range of services to support patients. Companies that learn how to make "targeted treatment solutions", as we call them, will deliver bigger shareholder returns than they have ever delivered before." The strategic direction GE is taking is a definitely a new chapter in writing. While GE is a leading manufacturer of the machines like Positron Emission Tomography (PET) and MRI scanners, Amersham is the leading player in the market for contrast drugs used in X-rays, CT scans, ultrasound, MRI, and PET scans. GE's management believes the acquisition will help it to create a healthcare company which will have combined 2003 pro forma revenues in excess of $13 billion. The Amersham Group employs over 10,000 people worldwide and had sales of $2.43 billion in 2002. It has three main business areas: medical diagnostics, protein separations and discovery systems. Amersham Health (59 percent of total Amersham sales in 2002) develops, manufactures and distributes diagnostic imaging agents and radiopharmaceuticals for all imaging modalities that are used in medical imaging procedures. Protein separations (17 percent of total Amersham sales in 2002) develops, manufactures and distributes chromatography purification systems, membrane products and reagents that are used in the development and manufacture of biopharmaceuticals and for the laboratory scale separation of proteins for research and drug development. Discovery systems (24 percent of total Amersham sales in 2002) develops, manufactures and distributes instruments, reagents and software that are used for drug discovery, research and development with applications including protein and DNA analysis for genomics and proteomics, cellular screening and bioassays. The combination of Amersham and GE Medical is expected by GE to be non-dilutive to 2004 earnings per share (before in-process research and development charges) and $0.01 accretive in 2005. GE expects to generate revenue synergies by the end of the third full year to the tune of $350-400 million per annum, which would translate into operating profit synergy benefits of $100-200 million per annum. ]]> <![CDATA[Sustainable agriculture proponent]]> https://biospectrumindia.com/news/95/1651/sustainable-agriculture-proponent.html https://biospectrumindia.com/news/95/1651/sustainable-agriculture-proponent.html Wed, 12 Nov 2003 19:22:00 +0530 p>IARI has served the country as a premier national institute for agricultural research, education and extension. The green revolution stemmed from the fields of IARI and its scholars constitute the core human resource of Indian agricultural research and education. Indian Agriculture Research Institute (IARI) provides national leadership in agricultural research. It conducts basic and strategic research to understand the process in all its complexity and undertakes need-based research, which will lead to crop improvement and sustained agriculture productivity in harmony with the environment. Developing new concepts and approaches is a priority at the institute. Over the years, IARI has not only developed innumerable technologies but has also delivered quality technical workforce, which is driving the Indian agricultural sector. Dr N Nagarajan, director IARI, said, "Whatever we have achieved is now a part of golden history. Presently, we are focused on achieving new goals through innovative ideas and techniques." "Apart from conducting research in crop management, we are trying to serve as a centre for academic excellence in the area of post-graduate education and human resources development in agricultural sciences," he added. "Biotechnology provides the tools, which can help scientist in doing research in a reduced time frame. Way back in 1985, only IARI had taken the initiative in this field by establishing the Center for Plant Biotechnology," he said. The National Research Centre for Plant Biotechnology was established with the objective of undertaking research, teaching and training personnel in the modern areas of molecular biology and biotechnology. Situated in the heart of Pusa Institute, the center is headed by Dr K Koundal. Explaining the role of the center, Dr Koundal said, "Since its inception, the center has acquired a high degree of scientific competence and excellent research facilities. The centre is working towards the national priorities of increased agricultural productivity and sustainability." He added, "we are working on basic plant molecular biology for understanding molecular mechanisms underlying essential biological processes. We also work towards advancement of agricultural development in India. Our ultimate aim is to serve as a national lead center for plant molecular biology and biotechnology research." The seed of Indian green revolution was sown and nurtured at IARI. Commenting on this Dr NN Singh, joint director research, IARI, said, "Its always motivating that our Institute is the flagship of Indian green revolution. There was a time when more than 70 percent of the total wheat grown on Indian soil was from IARI developed varieties. Even as of today, almost 50 percent of varieties of vegetables and flowers are developed at IARI. This percentage in cereals is somewhere around 30 to 35 percent." "Since there is no specific data available on this, so it is difficult to mention a figure for other crops with an authority," he added. Speaking on the status of transgenics at IARI, he said, "We are working on transgenics at a fast pace. Soon we will be bringing out transgenic tomato, rice, brinjal and cotton. These crops are on their way to be transferred to the industry." IARI has an "Advance Center for Plant Virology", which was established in 1988. Heading the center is Dr Anupam Varma, national professor, who is known for his energy, charm and dedication. "At the center we are developing strategies to fight with viruses. Since plants do not have an immune system so the effect of viruses on plants is more. We are identifying the viruses and developing resistance in plants," he said. "We have developed transgenic tomato, which is about to come in the market. We are also working on transgenic papaya, watermelon and cucumber," Dr Varma added. "In addition, we are working on a diagnostic kit for plants. Soon we are coming out with transgenic plant diagnostic kit for plant viruses. This would be a great breakthrough in diagnostics plant tissue culture. The 'National Facility for Quality and Virus Testing for Tissue Culture Raised Plants' is also a unique program at our centre. It is a DBT funded project." Though there are many departments and divisions at IARI, but there is a common bond amongst all of them, which is to make the Indian agriculture scenario better and better. And every researcher, doctor and their respective departments are working to achieve this goal. "Develop region-based transgenics" There can be no better person than the IARI director, Dr N Nagarajan to update us on the present Indian agricultural scenario. Dr Nagarajan started his professional career in 1974 as a wheat pathologist at IARI. He became the head, IARI regional station, Flowerdale, Shimla in 1980. Worked as ADG (plant protection), ICAR in 1988, DDG (crop science) in 1993. Now with a bigger responsibility he looks confident of meeting future challenges. In a talk with BioSpectrum, Dr N Nagarajan highlighted some issues facing Indian agriculture What is the most challenging aspect in today's agriculture scenario? Knowledge has become a patentable item these days. Among all the challenges facing the scientific community, Intellectual Property Rights (IPR) is the most demanding one. Every research institute is working towards a strong IPR cell. And IPR negotiations have became an important part of any technology transfer. How can transgenics become a success story in the Indian industry? For making transgenics successful in India, we need to focus on a regional basis. Infact whatever we have observed from past experience suggests that we have to develop region-based transgenics. The Government is also showing interest in bringing transgenics to the market, which is a good sign. But no country in the world is offering easy passage for transgenics. So here in India also we need to clear some regulations. What is the role that tie-ups or collaborations play in improving any research? It is always better to have collaboration in any research activity. Tie-ups with institutes like JNU, etc. are always in favor of the industry. Apart from this, we also need strong and long lasting collaborations with leading seed companies. At IARI we are always open for any possible collaboration. For example, we are having a successful tie-up with TERI, which is using IARI's Phytotron facility. At our institute we always want to create and maintain a synergy between the public and private sector. What is the status of plant biotechnology in India? As far as research work is concerned we have equal capabilities and strengths as that of any other developing nation. But in terms of plant biotech companies, we have not seen any big revolution in that segment. Here, in India this segment is yet to see a revolution, unlike pharma, where biotech word has now became a matter of survival. We need to improve the Indian plant biotech industry. Why is it that the private sector hesitates in joining hands with the public sector? There are always hindrances in finalizing any agreement between the public and private sector. But any such issue can be solved by negotiations. Unfortunately, the scientific community is not known as a good negotiator. We need to consider this aspect, develop some expertise and then it might be easier to deal with the private sector. Actually, a strong public-private relation is needed to boost the agri-biotech market. As of now, we have certain names from the corporate sector that are working with us, such as Syngenta and Apeda. But we need some strong long-term relations. What are IARI's future plans? We always tend to cater to the needs of the Indian agricultural industry. We first understand the requirement of the industry, convert it to reality and then again gave it back to the industry. We hope to continue doing the same. ]]> <![CDATA[Hepatitis A infection fights asthma]]> https://biospectrumindia.com/news/95/2244/hepatitis-a-infection-fights-asthma.html https://biospectrumindia.com/news/95/2244/hepatitis-a-infection-fights-asthma.html Wed, 12 Nov 2003 19:19:00 +0530 Hepatitis A infection fights asthma Hepatitis A infection fights asthma A dose of hepatitis A infection may be good for many people as it may trigger the body's immune response to fight other allergies, like asthma, according to a recent genetic study. Published in the science journal Nature, the study on Caucasians who were exposed to hepatitis A virus indicated that the infection reduces the risk of contracting asthma and similar allergies by four-fold. Apparently it is helped by the presence of a long version of the gene TIM-1 which is found in two-thirds of Caucasians, which triggers the immune response. "The long version of the gene may help the virus enter the cell more efficiently," Nature quoted the lead investigator of the study, Dale Umetsu of Stanford University, California. The gene may alter the immune system's response to allergens like pollen and dust. Allergy experts said this indicated that allergies may not have a single cause and depend a lot on the interaction between genetics and the environment. Hepatitis A virus thrives in unhygienic or dirty environment and affects about 1.5 million people worldwide every year. The disease usually subsides on its own, mainly due to the strength of the immune system. Antibodies are usually built up against the disease and most patients get cured without any specific treatment. Researchers hope to use this information to develop drugs that may induce better immune response in people to fight common allergies like asthma. It may be possible to develop vaccines, which may provide immunity against allergies. Statins, exercise ineffective against cholesterol It is bad news for the millions of people who have placed all their trust in regular doses of exercise and drugs like statins to lower their cholesterol levels and maintain a healthy heart, a comprehensive study in England has revealed. Statin is considered to be a biotech drug. The study covered 80,096 patients. Only a fifth of them (14,424) were using statins. Of them, nearly half the patients failed to achieve the desired levels of reduction in bad body fats. The study, "The Performance for Life", by cardiologist Adrian Brady at the Glasgow Royal Infirmary also revealed that regular exercise and a healthy diet were not very effective in reducing cholesterol." Healthy diet and exercise are, of course, good but they do not lower cholesterol an awful lot," Brady told a meeting of the Primary Care Cardiovascular Society in London in early October. Pfizer's Lipitor, a statin, is currently the world's top-selling single drug with annual sales of over $8 billion. However, Brady revealed that ineffectiveness of statins may be mainly due to irregular use and inadequate dosage. Another fourth of the patients reached their cholesterol targets after being treated appropriately with statins. The study also found that not enough patients with high cholesterol levels were being treated with the drug. The study was sponsored by AstraZeneca. The company, which markets its own drug Crestor, also called rosuvastatin, has claimed that its compound was more effective that the older statins evaluated by Brady's study. The other significant finding was that exercise and healthy diet could reduce cholesterol levels only by 8 to 10 percent. " Cholesterol is made by the liver and its very much something you are born with," Brady said. Mother's diet can alter baby's gene function For ages, a surefire grandma's recipe to pregnant mothers was the insistence on their having a healthy diet. Scientists and grandmothers have for long known that such a healthy diet was good for the offspring. Now there is a conclusive proof that this indeed was the correct prescription. And some recent experiments have dispelled another scientific assumption that the sequence of DNA was a major factor in an individual's predisposition to a particular disease. These experiments indicate that environmental factors like stress, diet and maternal nutrition can alter gene function without in any way making changes in the DNA sequence. In fact, a new field of study, epigenetics, has emerged to study this phenomenon. Researchers at the Duke University tried some experiments with yellow lab mice provided with triggers near the genes that control the traits related to color, obesity, diabetes and cancer, etc. to produce offsprings with the same traits. However, when fed with special vitamins and other supplements, the yellow mice delivered perfectly normal brown babies. "These special diets interact with the fetal mice genome and turn off the triggers that would have carried the abnormal traits into the next generation," said Dr Randy Jritle. Dr. Jirtle is a professor of radiation oncology at Duke and senior investigator of the study, which was reported in the August 1 issue of Molecular and Cellular Biology. Biotech to improve coffee varieties Biotechnology will come to the aid of the coffee industry. The Department of Biotechnology (DBT) has launched a "National Programme on Coffee Biotechnology" to develop drought and stress resistant varieties of coffee. The national program will involve four major institutionsâ€”Center for Cellular and Molecular Biology (CCMB), Hyderabad, Central Coffee Research Institute (CCRI), Chikmangalur, Karnataka, University of Agricultural Sciences, Bangalore and Madurai Kamaraj University (MKU), Madurai. This program is an extension of the government's Coffee Network project. CCMB has been doing the molecular characterization of coffee germplasm, supplied by CCRI. The germplasm includes a large number of elite genotypes of locally bred arabica varieties, commercially grown types, some Ethiopian collections, arabica and robusta types. Scientists have found that in at least four exotic Coffea species, the genetic variability was very low. They also found generic affinities between these species. A web-based database has been prepared. Researchers have also developed 80 markers for parental survey of 11 elite genotypes. Studies are also continuing at MKU, Madurai and CCRI, Mysore on transformation of Coffea arabicaâ€”Kent and Cauvery cultivars for leaf rust resistance. An Agro-bacterium binary vector with rice chitinase and tobacco glucanase was constructed. The Robusta coffee is also being transformed to regulate caffeine biosynthesis. ]]> <![CDATA[Accelrys announces structure-based design tools for drug discovery]]> https://biospectrumindia.com/news/95/1950/accelrys-announces-structure-based-design-tools-for-drug-discovery.html https://biospectrumindia.com/news/95/1950/accelrys-announces-structure-based-design-tools-for-drug-discovery.html Wed, 12 Nov 2003 19:15:00 +0530 Accelrys announces structure-based design tools for drug discovery Accelrys has released DS modeling 1.2-SBD (Structure-Based Design tools) for the Discovery Studio family of products. DS Modeling 1.2-SBD is a client-server environment for in silico drug design on WindowsÃ‚®-based personal computers. Developed for life science research organizations, it contains functionality for fast, accurate and flexible docking and scoring of candidate drug ligands to a target macromolecule receptor site, de novo ligand design and in situ ligand energy minimization using validated scientific methodology. These SBD tools allow the use of increasingly abundant 3D receptor structures in hit finding and lead optimization. Accurate and robust scoring of interactions between ligand and poses aid in understanding of inhibitor affinities. Docking tools are streamlined with energy minimization of ligands in situ and scoring for virtual high throughput screening experiments. Scaffold hopping and design of novel inhibitor analogs is also enabled with de novo design tools. For further details, contact: aginsberg@accelrys.com Pooja Lab manufactures temperature and humidity test chamber Pooja Lab Equipments has manufactured temperature and humidity test chambers of different capacities. These are design eco-friendly test chambers using high efficiency hermetically sealed refrigeration system used for climatic and durability tests of electrical and electronic components, apparatus and materials for simulated tropical and extreme tropical condition in pharmaceuticals and chemicals, electronics/electrical, telecommunications, defense, aerospace, engineering etc. All models feature precision microprocessor based controls and efficient mechanical air convection for exceptional uniformity and control of temperature and humidity. The temperature range is from â€“20oC to 100oC and the humidity range is from 35 percent to 95 percent between 10oC to 60oC. For further details, contact: poojalab@vsnl.com Spray ball from Industrial Equipwash Inc. The spray ball is a simple yet a highly effective device for the internal washing of process and storage tanks. A spray ball, powered by the cleaning fluid, generates a high-pressure spray to clean every vessel. There is only one moving part and there is no maintenance whatsoever. No lubricant is necessary which prevents any risk of oil or grease contamination of the product, making the spray ball ideally suited for hygienic sensitive applications. Spray balls are widely accepted for applications in the food, beverages, pharma and chemicals industries, where a fast and through cleaning is essential. These versatile units operate with a wide variety of chemicals and detergents frequently in hostile environments and temperatures upto 1200C and water pressure around 208 kg/cm2. Spray balls are manufactured from high-grade stainless steel AISI 316. For further details, contact: iewi@vsnl.net ]]> <![CDATA[Indian firms harness streptokinase]]> https://biospectrumindia.com/news/95/1157/indian-firms-harness-streptokinase.html https://biospectrumindia.com/news/95/1157/indian-firms-harness-streptokinase.html Wed, 12 Nov 2003 19:06:00 +0530 Bharat and Shantha make India proud in biopharma. India can take pride in another development. In October, two Hyderabad-based companies Bharat Biotech and Shantha Biotechnics have announced the launch of Streptokinase, a drug for dissolving blood clots and used as a life-saving drug in case of acute heart attacks and other conditions like deep vein thrombosis, arterial occlusions and pulmonary embolism. It is believed the duo are the first few biotechnology companies India to launch indigenously developed products. With this the battle for control of the streptokinase battle has begun. Though there would a silent battle between the two players because they have the same place of origin, the real battle is the desi versus MNC brands. There would also be a debate as to what is so great in developing Streptokinase. It is not a technical marvel. But the counter is if it was not so great why have others not developed it? Three things matter, technology, market opportunity, and the ability to develop and set up the facility. The two have been able to put all this together. According to market feedback, Streptokinase is currently available at Rs 3,800 a dose. The affordability of the drug is important in the light of the fact that over 60 million Indians are affected with coronary arterial disease and according to WHO by the end of this century India would account for more than half of the total heart patients in the world. "The market for Streptokinase in India is valued at over Rs 65 crore and is poised to grow at 25 percent per annum," said Varaprasad Reddy, MD, Shantha Biotechnics. Bharat too gives a similar market estimate. Bharat Biotech's recombinant Streptokinase, called Indikinase, is a protein produced from genetically manipulated Escherichia coli. This enzyme is a first line therapy for management of acute myocardial infarction, deep vein thrombosis, arterial occlusion, etc. The total project cost was Rs 30 crore for producing Indikinase. Technology Development Board, DST funded Rs 11 crore, SBI Rs 7 crore, the rest mobilized by internal generation. The product has been duly approved by national regulatory committees. It estimates the market size for the product to be around Rs 50 crore. Said Dr Krishna M Ella, chairman and managing director, Bharat Biotech, "Manufacturing indigenously, the cost of this drug, which has all along been imported into India, can come down. The recombinant Streptokinase scores over its non-recombinant counterpart in many respects. The most significant one being able to prevent excessive bleeding compared to the existing products." Shantha Biotechnics, after three years of R&D and an investment of Rs 10 crore, announced the launch of its third recombinant product Streptokinase, branded Shankinase. According to the company, this indigenous clot buster drug recombinant Streptokinase conforms to international standards. "We benchmark our products against the highest quality and lowest end-user prices," said Varaprasad Reddy, MD, Shantha Biotechnics. Shankinase is likely to be priced in the Rs 1,000 bracket. "The pricing will be in consonance with our commitment to highest quality at affordable prices," said Reddy. According to the company release, the safety and efficacy of Shankinase compared with commercially available natural Streptokinase in patients with acute Myocardial Infarction (heart attack) was proven in a multi-centric double blind randomized phase III trials. The drug's potency was tested by chromogenic assay method and certified by a third party international authority, National Institute of Biological Standards and Controls, UK. "Shankinase aims to garner a 10 percent market share in the year following the launch," said Reddy. He added, "Doctors are the acid test of the efficacy of any drug," said Reddy confident that Shankinase too will bag all the kudos and the awards just like the earlier two products from the company. The pricing of Indikinase is not yet announced, but it too could be in the same range as Shantha. It is not that there are no other biotech Streptokinase. Cadilla Pharma has a Streptokinase, which is a thrombolytic agent of bacterial origin, STPase. CPL's streptokinase brand is a purified preparation of Streptokinase produced through bacterial fermentation. The product thus produced, is purified using the most sophisticated protein purification techniques. And CPL claims that its STPase is the only streptokinase indigenously produced in India, which is at par with world standards. Irrespective of who has what products, who claims what, the good news is that Indian are building the capabilities. Ch. Srinivas Rao, with inputs from Nandita Singh in Hyderabad ]]> <![CDATA[Spurious Bt cottonseeds - Is it the right way?]]> https://biospectrumindia.com/news/95/3905/spurious-bt-cottonseeds-is-it-the-right-way.html https://biospectrumindia.com/news/95/3905/spurious-bt-cottonseeds-is-it-the-right-way.html Wed, 12 Nov 2003 19:00:00 +0530 The use of spurious/fake things has become a part of everyday life in India. In anything that we buy, electronic goods, drugs, pesticides, fertilizers, healthcare products, we find bogus products. Now it is time for bogus seeds Some of the seed companies in Gujarat have been involved in selling spurious Bt cotton seeds at a much lower price against the Mahycoâ€“Monsanto's Bollgard. Till date only Mahycoâ€“Monsanto Biotech Ltd (MMB) has the official approval for the commercial production of Bt cotton from the Genetic Engineering Approval Committee (GEAC) of the Ministry of Environment and Forestry (MoEF). Reports say that the farmers in Gujarat are earning big profits by using spurious seeds. MoEF to evaluate performance of Bt cotton Ministry of Environment and Forests (MoEF) has decided to evaluate the performance of Bt cotton for a period of three years starting from 2002. For the kharif 2003 MoEF has already constituted a committee to assess the performance of Bt cotton. The committee is headed by Ashish Bahuguna, joint secretary, ministry of agriculture, and includes Dr G Kalloo, deputy director general, ICAR, Dr CD Mayee, director, Central Institute Cotton Research, Nagapur, Dr TV Ramanaih, director DBT and Dr R Warrier, member secretary GEAC. The farmers are using hybrid Bt cotton seeds sold under brand names like Rakshak, Virat, Captain F-1 Hybrid Cotton Seeds, Research Hybrid cotton F-1 (Tilak), Trishul (F1), Kavach F-1, hybrid Kapas-151, Suraksha-hybrid cotton seeds, Research hybrid cotton F-1, Krushi-357, Sarathi. These are sold at a lesser price than Bollgard (Rs 1600 per packet), which is marketed by MMB. Ahmedabad-based Navbharat Seeds owned by Dr DB Desai, a former employee of Mahyco, sold the hybrid seeds containing the same Cry1AC gene, incorporated in Bollgard, even when GEAC had not given approval to MMB. The Central Institute Cotton Research (CICR), Nagpur has carried out PCR and ELISA tests on these cottonseeds and confirmed that the above brands have tested positive for the presence of Cry 1 Ac gene. The above hybrids have not been approved by the GEAC and therefore production/sale of the above hybrids is a clear violation of the rule of 1989 and liable for punitive action under the Environment (Protection) Act 1986. MMB had filed a complaint with the Government of India against the sale of spurious Bt cotton last year. Accordingly the MoEF has asked the Gujarat government to take appropriate steps to curb the sales of spurious Bt cottonseeds in the state. But the state government has failed to take steps against the companies. It is an irony that on the other side, Department of Science and Technology (DST) and Gujarat government are promoting biotechnology in a big way by organizing programs, seminars and exhibitions showcasing the strengths of Gujarat. When BioSpec-trum contacted Rajesh Kishore, secretary, DST for his comments on the issue, he informed, "it is not appropriate for me to say anything at this moment. I am waiting for the information from agriculture department, which is planning to organize a conference on agribio-technology this November, after the success of pharma-biotech event held on September 29." Good rains, more acreage According to Vishwa Nath, chairman and managing director, Cotton Corporation of India, Indian cotton cultivation during the 2003-04 season (October-September) is expected to increase by 12 percent, to around 85 lakh hectares. This is mainly due to the good and favorable monsoon during the initial two months and the farmers are reported to have bought more certified seeds as compared to previous year. Area under Bt cotton has also increased to around 1.25 lakh hectares compared to 40,000 hectares in the previous season. As against the last year's sale of about 72,000 packets, MMB was able to sell over 2,00,000 packets this season. In Gujarat alone, the company has sold over 1,00,000 packets this season. However industry sources say that there is a large quantity of illegal Bt cotton available in Gujarat, but there are no figures available for these illegal plantings. Ranjana Smetacek, director (corporate affairs), Monsanto India said, "Any spurious product brings a bad name to the genuine product. Clearly, any negatives from illegal Bt cotton would lend a bad name to the technology and therefore damage our interests and those of other seed companies working within the regulatory system to market Bt cotton seeds." C Kameswara Rao, founder, Foundation for Biotechnology Awareness and Education, Bangalore, said that the unauthorized cultivation of Bt cotton in Gujarat is bad for the future of GM crops in the country on at least three counts. First, it will encourage similar misadventure in other parts of the country. Second, it gives a new whip for the NGOs to ridicule the regulatory measures and GM crops and lastly it will further delay the introduction of other GM crops in India by generating fresh controversies. Ironically it is Monsanto's technology that is encouraging companies to produce and sell fake hybrid seeds as the technology is not patent-protected. There are a number of co-licensees with whom MMB has signed agreements and they are all working within the regulatory system to introduce Monsanto's Bt gene into their hybrids. Spurious seed sale may result in poor investments in R&D from the private participants who really want to sell quality seeds. According to reports, companies like Nath seeds, Ankur seeds, Ajeet seeds, Krishidam, Mahendra and Nuziveedu seeds are already working on Bt cotton trials and are expected to release their products by 2006. If the state governments fail to take action against the sale of spurious Bt cotton, the scientists working on such projects may be demoralized of taking up research work. Then what next.... The companies, which are doing research should take up the initiative to bring in awareness about spurious Bt seeds by organizing one to one farmer meeting, group farmer meetings etc. Even the state governments should actively participate in promoting the technology by initiating stringent steps against the lawbreakers. MMB is already working in this regard by conducting field days where in its field staff visits the villages at the time of crop harvesting, sending mailers, print materials like posters, banners, etc. to farmers. In the past, MMB and the government have put out messages for farmers, warning them against the products of spurious seed sellers. Narayan Kulkarni ]]> <![CDATA[India's own Bt gene ready for transfer]]> https://biospectrumindia.com/news/95/2081/indias-own-bt-gene-ready-for-transfer.html https://biospectrumindia.com/news/95/2081/indias-own-bt-gene-ready-for-transfer.html Wed, 12 Nov 2003 18:41:00 +0530 NBRI, Lucknow, has synthesized two new Bt genes. Great news. Greater is that it has takers. Every Indian prides in "Made in India" tag. But the feeling is further cherished if one learns that indigenously developed biotech products comparable at global levels have been developed "by the Indians, of the Indians, for the Indians". October saw one such moment, which could go into the history books, when seven Indian seed manufacturing companies came together under a consortium Swarna Bharat Biotechnics Pvt Ltd (SBBPL) and signed an agreement to acquire the Indian Bt technology from National Botanical Research Institute (NBRI), Lucknow. This development assumes significance for two reasons. One, the ability to develop the technology, in this case the synthesis of two Bt genes Cry 1 AC and Cry1 Ec. The other to find takers. The credit for the development of these genes goes to Dr Rakesh Tuli and his team at NBRI. Dr Tuli is known to be the first to have cloned an agricultural gene in India, while he was with Bhabha Atomic Research Centre, almost about 12 years back. Two years ago, he and his team synthesized the genes. Cry 1 AC gene produces a particular endotoxin (protein) in the plant, which is poisonous to certain lepidoterous bollworms such as American boll worm, spotted boll worm, and pink boll worm. Commenting on the superiority of the technology, Dr Tulli said, "These two genes provide protection against bollworm as well as the tobacco caterpillar, so the cotton farmer will have a broad umbrella of protection against the cotton lepidoteran pests. We can proudly claim our technology is superior to the available technology." The alliance with SBBPL will throw open a new chapter in technology transfer business. This initiative will not only help bridge the widening technology divide, but also reduce the consequent loss due to delay in introducing the products and high cost involved in acquiring technology. Dr P Sateesh Kumar, executive director, SBBPL, and director of Prabhat Agri Biotech, explained "SBBPL was formed to help the member companies to choose and develop biotech tools applicable to crop improvement and also co-ordinate jointly for the work on getting the regulatory clearances. SBBPL is the first of its kind public-private collaboration to address the concerns of small and marginal seed manufacturers to access high-cost technology at lower costs." According to the NBRI-SBBPL MoU, the consortium has been licensed the two Bt genes for an upfront fee of Rs 75 lakh over a three year period, along with a royalty of 3 percent. "The benefit for us is that we can access the technology distributing the Rs 75 lakh technology fee among the seven members," added Dr Kumar. The interesting element of the consortium is that it consists of owner-managed companies only. The reason cited Dr Kumar is that owner-managed companies can take quick decisions. The member companies include Nuziveedu Seeds, Ganga Kaveri Seeds, Pravardhan Seeds, Prabhat Agri Biotech, Kaveri Seeds, Nandi Seeds, and Vikki's Agro Tech. Moreover, the seven member consortium commands a market share of 30 percent of total cotton seeds and enjoys a 50 percent share of the entire proprietary cotton hybrid seed marketed in the country. That the MoU has been signed doesn't mean that the Bt crops will be ready soon. Dr Kumar explains, "We will be using this technology for cotton. Though, it can be use for other crops like radish, getting the biosafety clearances for food crops will take a very long time. So we are looking at cotton. It will take us about 18 months to transfer the technology to the material. Further, there will be biosafety assessment, and two years of field test. With all these things, it is likely that we would have the Bt seeds by 2005-06 in the market." The consortium is understood to have spent about Rs 5 crore on the initial work and is planning to apply for regulatory approval. Further, the consortium is considering setting up of a common R&D facility for future developmental activities. The legal Bt cotton of Mahyco Monsanto is estimated to have been sown in about 60,000 acres in 2002-03 and in about 2 lakh acres of land in 2003-04. The Mahyco-Monsanto is estimated to have spent in excess of Rs 50 crore on developing the technology. But the current alliance has already found a favorable attitude from activists. Probably, the pride to nourish Indian technology finds their approval. On the cost side too, the claims are approbatory. Said Dr Kumar, "Indian farmers spend about Rs 1,600 crore on insecticides for controlling the pest in cotton fields and more precisely Rs 1,200 crore on bollworm. Further, we will be able to sell our products at as low as Rs 800 per packet of 450 gm." With all the things in its favor the alliance is well positioned to bring a revolution. But all it needs is to get the act together. Ch. Srinivas Rao ]]> <![CDATA[Bio News November]]> https://biospectrumindia.com/news/95/1666/bio-news-november.html https://biospectrumindia.com/news/95/1666/bio-news-november.html Wed, 12 Nov 2003 18:36:00 +0530 Biocon Biocon's H1 revenues soar Biocon India Ltd has announced a very impressive first-half results for the period ended 30 September. Biocon recorded a total sales of Rs 259 crore, up from Rs 128 crore in the corresponding period during 2002-03. Its Earnings Before Interest, Taxes, Depreciation & Amortization (EBITDA) stood at Rs 87 crore up by 172 percent. It may be recalled that the company was the #1 company according to BioSpectrum-ABLE Top20 Survey with recorded sales of Rs 255 crore, and a profit after tax of Rs 36 crore. Kiran Mazumdar-Shaw, chairman and managing director, Biocon said, "These results demonstrate the enormous progress the company has made over the past year. With our strong links with high-quality customers, and substantial increase in capacity coming on stream next year, I am confident that the future will achieve tremendous growth." After a careful review of opportunities for the remainder of the year, the Board is of the view that the results for the 12 months ending 31 March 2004 shall have sales in excess of Rs 520 crore and profit after tax of Rs 130 crore. One of the key reasons for the growth of during the first half has been on account of increased exports. Exports in the current half-year period have shown a sharp increase of 189 percent over the corresponding period in 2002-03, largely driven by exports of Lovastatin and Simvastatin to USA and Europe. Biocon's total exports in 2002-03 stood at Rs 108 crore. The company is on a major expansion drive developing additional capacity to meet the demand for its products. This includes the development of the newly acquired 50 acre site in Bangalore where expansion of capacity of Syngene International Limited (a Biocon subsidiary), quadrupling of fermentation capacity and the new biologicals plant are all proceeding as on schedule. It plans to invest close to Rs 500 crore in the next three years. The plant for the production of r-human insulin is also on track and expects to launch the product in the Indian market by March 2004. The Board has also agreed to proceed with the preparatory work for an IPO planned for the first quarter of 2004. Existing advisors have been retained. DSP Merrill Lynch and Kotak Mahindra Capital company will be the book running lead managers, while HSBC Securities & Capital Markets will be the co-book running lead manager. The Board will review progress to confirm the IPO timetable by the year-end. DBT to act as nodal agency for Asian Biotech Consortium The Department of Biotechnology (DBT) will act as a nodal agency for a proposed Asian Biotechnology Consortium to be set up in New Delhi, under the aegis of the Ministry of External Affairs (MEA). Twenty-two Asian countries will come together for this under the Asia Cooperation Dialogue (ACD) launched in Cha-am Thailand in June, last year. India agreed to take the lead in establishing the consortium to foster greater cooperation among the ACD countries in biotechnology. The ACD member countries are: Bahrain, Bangladesh, Brunei Darussalam, Combodia, China, Indonesia, India, Japan, Kazakhstan, Kuwait, Laos (PDR), Malaysia, Myanmar, Oman, Pakistan, Philippines, Qatar, Singapore, Sri Lanka, South Korea, Thailand and Vietnam. A two-day meeting of the ACD countries concluded in New Delhi recently after considering the concept paper on setting up of the consortium and the modalities of going about it, which were prepared by India. The meeting called by the MEA, in association with DBT, ended with a number of recommendations on setting up of a core fund, membership and launching of an ACD biotech website to network the countries for exchange of information and collective action. The meeting agreed to collectively address issues related to the development of biotech infrastructure and expertise, bio-safety, IPR issues as well as technology access, transfer and commercialization for the socio- economic progress of the region. Matters pertaining to the modalities of setting up of the fund such as membership and other technical issues would be taken up at the first meeting of the Apex Governing body which is planned to be held in China soon. In his opening remarks, Dr RM Abhayankar, secretary MEA, underscored the need for a consensus among ACD member countries to work together for the socio-economic development of the region, exploiting the full potential of biotechnology. Dr Manju Sharma, secretary DBT, said that the dialogue should also address institutional framework, biodiversity utilization, capacity building and regulatory guidelines. Study confirms better results of Bt cotton A study conducted by the University of Agricultural Sciences, Dharwad, at the University's Regional Agricultural Research Station (RARS) farm and Nelahal village in Raichur district, Karnataka, has confirmed that the cultivation of Bt cotton will reduce the use of pesticides and bring a substantial reduction in costs to the farmer while improving his profit margins. Commenting on the findings, Dr BV Patil, associate director of research and head Entomology department, RARS Raichur, who led the study team said, "For a long time now there has been a debate on the Bt cotton issue. For us, this was a fact-finding mission and we are confident of the veracity of our research and are convinced that Bt cotton does play a significant role in reducing the farmer's worries. Our study clearly establishes the fact that if maximum benefit has to be derived from cultivating Bt cotton, then it is important to isolate the crop from normal cotton or other hybrids and cultivate it separately. This would ensure pest resistance and better yields." The study revealed that more bollworm damage was recorded in conventional cotton and NHH-44 hybrids (the commonly used local hybrid) in both locations as compared to the lesser damage to Bt cotton. It further reported that Bt cotton required only three to four applications of pesticide for bollworm control, where as the conventional cotton and NHH-44 hybrids required four to nine sprayings in both locations. Dr Patil noted that the Bt cotton plots accounted for an expenditure of only Rs 750 and Rs 1,210 on plant protection input costs per acre, as opposed to Rs 1180 and Rs 3310 on conventional cotton in the RARS farm and Nelahal locations respectively. At the end of the study, it was found that the Bt cotton plots recorded a net profit of Rs 13,998 and Rs 13,521 per acre in the RARS farm and Nelahal village which added up to a 31.12 percent and a 42.18 percent increase respectively, in net profit over NHHâ€“44, at the same locations, under irrigated conditions. It was also found that sucking pest incidence, particularly 'thrips' in the early stage and 'aphids' in the later stage was equal in all the cotton plots in both locations. The study, which was conducted in 2002-03 involved the actual trials and collation of primary data to study the behavior of pests and their impact on cotton. At each location, three hybrids and a local popular hybrid were cultivated on one acre and after taking into account the input cost in each location, the economic benefits were calculated. DBT to spend Rs 90 crore on bioinformatics DBT is planning to spend about Rs 90 crore on the bioinformatics sector in the next five years. "The Department of Scientific and Industrial Research is also eager to spend on this sector as the bioinformatics market is seen at $5-6 billion by 2007," said Prof Ashok S Kolaskar, vice chancellor, University of Pune. Speaking at the first anniversary celebrations of SciNova Informatics at Pune recently, he said that industryâ€“institute partnership is a must for the growth of the biotech industry. If they work together it is win-win situation and both will be benefited. "Many companies in bioinformatics are making inroads both in the local and international arena. One such example is Bangalore-based Strand Genomics. The time is right to push ahead. But the companies have to concentrate on IPR issue, niche areas. Then the growth will be higher," he added. Pratima Kirloskar, president, Pune chapter of The Indus Entrepreneur (TiE), noted that innovation and risk taking are essential for success of any organization. In this regard the small and medium entrepreneurs should also look at strategic alliance with other companies. The entrepreneurs should support the innovators by taking risks so that the dreams of the innovators come true, she added. On November 14, TiE is organizing a conference at Pune where in 10-15 new technologies will be showcased besides two oversees technologies. One is from Israel and other is from Finland. Praj looks at alternatives for ethanol fuel production With the imminent introduction of ethanol fuel in many countries including India, Thailand, Australia and enhancement in ethanol usage in North America, Canada, and Europe, Pune-based Praj Industries, an ISO 9002 company, is planning to introduce tropical sugar beet in India and other tropical countries. Sugar beet is an alternative for sugarcane as a source of ethanol production. Praj has already taken a lead in this field and is working with Syngenta. Praj says that sugar beet is not only economically viable, but it is also environmental friendly to process. It will allow farmers to rotate crops and better manage fertility of the soil. Praj has been working to make ethanol a sustainable energy source by bringing in reliable and cost-effective technology for its production. Having entered into a technical collaboration with Delta T of the US, Praj has already commissioned India's first (and probably South East Asia's first) Molecular Sieve Dehydration technology (MSDH) ethanol fuel plant in India. Delta T is a leader in MSDH technology for ethanol fuel production. This plant adheres to international standards and produces anhydrous ethanol. At Praj, innovation has always held center stage in any developmental activity. In continuation of its quest to bring "value added technologies" to the industry, it has expanded its R&D facility, which it called Matrixâ€“The Innovation Center. Biotechnology led solutions for converting agro molecules into bio-products is the central theme of Matrix. Matrix is equipped with state of the art facilities for conducting extensive trials. It has taken up the challenge of making biofuels from a variety of feedstocks. Some of the programs, which have been undertaken by Matrix, include enhancing sugarcane to ethanol economics, energy crops for ethanol production and more. Some of the identified crops include tropical sugar beet, sweet sorghum and tapioca. Biomass is another futuristic feedstock identified by Matrix. With the help of Matrix, Praj will continue to promote technological solutions for better yields and newer production methods combined with low energy costs. Established in 1985, Praj focused upon alcohol technology and engineering of alcohol plants and became a key player in cane molasses based alcohol technology with a number of processes and systems for alcohol production to its credit. Today, it has over 250 references in 25 countries across five continents. From being an Indian Engineering Company, Praj has acquired an international repute and has its own offices in Singapore and Bogota, Colombia (South America). SIIL to launch combination vaccine by 2004 Serum Institute of India Ltd (SIIL), a Pune-based vaccine manufacturer is making good progress on developing new combination vaccines. It is working on quadra valent combination vaccine (Hepatitis B-DPT). Dr SD Ravetkar, senior director, SIIL, informed, "This vaccine will reduce the number of injections required for children, by one. We are developing this indigenously as we have all the four components with us to develop the vaccine. Serum will be the only company after GlaxoSmithKline to launch such a combination vaccine in the world, which it will launch before the end of first quarter of next year. Once we launch the vaccine in India we will look forward to launch it in other countries after conducting trails." Companies like Shantha Biotechnics and Panacea Biotec are also working on the same project. But these companies are dependent for components like DPT. Serum is a pioneer in manufacturing DPT vaccines in India. Serum has been working on this vaccine since the last three years.Explaining about the other projects, Dr Ravetkar, who pioneered the DPT vaccine project in SIIL said, "the next in pipeline is Haemophilusâ€“B vaccine. We are co-developing this with a European company, since the last one year. We have done this it to strengthen the strategic alliance and enhance economies on both sides. The research on this vaccine has already commenced and we will be able to launch it by 2005. " He added, "Another one in the pipeline is a pentavalent vaccine. It is tricky thing to balance all the five components (ie combination of Hepatitis B-DPT-Haemophilusâ€“B vaccines). We are at the lab study stage." Asked about the investments made by SIIL in developing vaccines, Dr Ravetkar informed, "capital investment in vaccine development is high, as we have to do research under facilities of international repute, carry out multicenter clinical trails and have to meet the GMP standards." SIIL, a flagship company of the Poonawalla Group of Companies, is supplying the vaccines at subsidized price to the Indian customers. Dr Ravetkar, recipient of many awards including the outstanding Achievement Medal by the International Biographical Center, Cambridge UK, says, " it is mainly because of our chairman Dr C S Poonawalla, a techno-commercial man with a philanthropic mind, who believes in providing quality products at cheaper price to the Indian customers." SciNova to see four-fold increase in its turnover Pune-based SciNova Informatics, a discovery informatics company, is set to increase its turnover by four fold by the end of this financial year. In its first year the company was able to generate revenue of about Rs 25 lakh. Speaking to BioSpectrum, at the first anniversary celebrations of the company, on October 14 at Pune, Rajeev Gangal of SciNova said, "We have made good inroads in the domestic market with our products. The first version of Prometheus is already under trail. Once the trail is over we will go in for IPR for this product. Meanwhile, we are now working on a NMR project for Astra Zeneca and it will be completed by March next year. Discussions are also on with other major biotech and pharmaceutical companies." When asked about SciNova's entry into global market, he said, "First we want to concentrate on the local market. However few European generic companies have approached us for the drug discovery process. We are also showcasing our product technologies in all major events." SciNova is interested in tapping the huge database available with scientists, hospitals etc. In this regard it is also interacting with some scientists based outside Pune. With its experienced IT professionals who are capable of implementing IT solutions for bio and chemoinformatics, it is offering services in the form of customized literature database curation and customized IT support for bio/chemo-informatics groups. Spurious Bt cottonseeds - Is it the right way?The use of spurious/fake things has become a part of everyday life in India. In anything that we buy, electronic goods, drugs, pesticides, fertilizers, healthcare products, we find bogus products. Now it is time for bogus seeds Some of the seed companies in Gujarat have been involved in selling spurious Bt cotton seeds at a much lower price against the Mahycoâ€“Monsanto's Bollgard. Till date only Mahycoâ€“Monsanto Biotech Ltd (MMB) has the official approval for the commercial production of Bt cotton from the Genetic Engineering Approval Committee (GEAC) of the Ministry of Environment and Forestry (MoEF). Reports say that the farmers in Gujarat are earning big profits by using spurious seeds. MoEF to evaluate performance of Bt cotton Ministry of Environment and Forests (MoEF) has decided to evaluate the performance of Bt cotton for a period of three years starting from 2002. For the kharif 2003 MoEF has already constituted a committee to assess the performance of Bt cotton. The committee is headed by Ashish Bahuguna, joint secretary, ministry of agriculture, and includes Dr G Kalloo, deputy director general, ICAR, Dr CD Mayee, director, Central Institute Cotton Research, Nagapur, Dr TV Ramanaih, director DBT and Dr R Warrier, member secretary GEAC. The farmers are using hybrid Bt cotton seeds sold under brand names like Rakshak, Virat, Captain F-1 Hybrid Cotton Seeds, Research Hybrid cotton F-1 (Tilak), Trishul (F1), Kavach F-1, hybrid Kapas-151, Suraksha-hybrid cotton seeds, Research hybrid cotton F-1, Krushi-357, Sarathi. These are sold at a lesser price than Bollgard (Rs 1600 per packet), which is marketed by MMB. Ahmedabad-based Navbharat Seeds owned by Dr DB Desai, a former employee of Mahyco, sold the hybrid seeds containing the same Cry1AC gene, incorporated in Bollgard, even when GEAC had not given approval to MMB. The Central Institute Cotton Research (CICR), Nagpur has carried out PCR and ELISA tests on these cottonseeds and confirmed that the above brands have tested positive for the presence of Cry 1 Ac gene. The above hybrids have not been approved by the GEAC and therefore production/sale of the above hybrids is a clear violation of the rule of 1989 and liable for punitive action under the Environment (Protection) Act 1986. MMB had filed a complaint with the Government of India against the sale of spurious Bt cotton last year. Accordingly the MoEF has asked the Gujarat government to take appropriate steps to curb the sales of spurious Bt cottonseeds in the state. But the state government has failed to take steps against the companies. It is an irony that on the other side, Department of Science and Technology (DST) and Gujarat government are promoting biotechnology in a big way by organizing programs, seminars and exhibitions showcasing the strengths of Gujarat. When BioSpec-trum contacted Rajesh Kishore, secretary, DST for his comments on the issue, he informed, "it is not appropriate for me to say anything at this moment. I am waiting for the information from agriculture department, which is planning to organize a conference on agribio-technology this November, after the success of pharma-biotech event held on September 29." Good rains, more acreage According to Vishwa Nath, chairman and managing director, Cotton Corporation of India, Indian cotton cultivation during the 2003-04 season (October-September) is expected to increase by 12 percent, to around 85 lakh hectares. This is mainly due to the good and favorable monsoon during the initial two months and the farmers are reported to have bought more certified seeds as compared to previous year. Area under Bt cotton has also increased to around 1.25 lakh hectares compared to 40,000 hectares in the previous season. As against the last year's sale of about 72,000 packets, MMB was able to sell over 2,00,000 packets this season. In Gujarat alone, the company has sold over 1,00,000 packets this season. However industry sources say that there is a large quantity of illegal Bt cotton available in Gujarat, but there are no figures available for these illegal plantings. Ranjana Smetacek, director (corporate affairs), Monsanto India said, "Any spurious product brings a bad name to the genuine product. Clearly, any negatives from illegal Bt cotton would lend a bad name to the technology and therefore damage our interests and those of other seed companies working within the regulatory system to market Bt cotton seeds." C Kameswara Rao, founder, Foundation for Biotechnology Awareness and Education, Bangalore, said that the unauthorized cultivation of Bt cotton in Gujarat is bad for the future of GM crops in the country on at least three counts. First, it will encourage similar misadventure in other parts of the country. Second, it gives a new whip for the NGOs to ridicule the regulatory measures and GM crops and lastly it will further delay the introduction of other GM crops in India by generating fresh controversies. Ironically it is Monsanto's technology that is encouraging companies to produce and sell fake hybrid seeds as the technology is not patent-protected. There are a number of co-licensees with whom MMB has signed agreements and they are all working within the regulatory system to introduce Monsanto's Bt gene into their hybrids. Spurious seed sale may result in poor investments in R&D from the private participants who really want to sell quality seeds. According to reports, companies like Nath seeds, Ankur seeds, Ajeet seeds, Krishidam, Mahendra and Nuziveedu seeds are already working on Bt cotton trials and are expected to release their products by 2006. If the state governments fail to take action against the sale of spurious Bt cotton, the scientists working on such projects may be demoralized of taking up research work. Then what next.... The companies, which are doing research should take up the initiative to bring in awareness about spurious Bt seeds by organizing one to one farmer meeting, group farmer meetings etc. Even the state governments should actively participate in promoting the technology by initiating stringent steps against the lawbreakers. MMB is already working in this regard by conducting field days where in its field staff visits the villages at the time of crop harvesting, sending mailers, print materials like posters, banners, etc. to farmers. In the past, MMB and the government have put out messages for farmers, warning them against the products of spurious seed sellers. Narayan Kulkarni ]]> <![CDATA[BioEvents]]> https://biospectrumindia.com/news/95/2607/bioevents.html https://biospectrumindia.com/news/95/2607/bioevents.html Wed, 12 Nov 2003 18:26:00 +0530 Symposium on GM technology Symposium on GM technology Gene Campaign is organizing a symposium on "The Relevance of GM Technology to Indian Agriculture and Food Security" on 26-27 November 2003, at the India Habitat Center, New Delhi. The aim is to raise awareness about the various aspects of GM technology and assess their relevance and applicability to Indian conditions. The discussions will examine the role of GM technology in increasing food production and the role of alternative strategies, the socio-economic impact of this technology and the ability of India and other developing countries to implement GM technology in a safe and responsible manner .For more information, contact: genecamp@vsnl.com RNA in Drug Development conference The Knowledge Foundation Inc. is organizing the 3rd annual conference on RNA in Drug Development from 10-11 November at San Diego, CA. The conference will address the latest challenges within RNA stability, RNA delivery, designing functional siRNA's and discovering new opportunities for using RNA as a target. This symposium will provide a competitive insight into the current state of RNA research and development by bringing together leading researchers focusing on areas like RNA intereference, ribozymes, aptamers, antisense technology, alternative splicing and targets for antibiotic therapies. For more information, contact: meder@knowledgefoundation.com Pharma Expo 2003 Confederation of Indian Industry (CII) is organizing its first flagship international exhibition and conference on the pharmaceutical industryâ€”Pharma Expo 2003â€”at Mumbai. The exhibition to be held from 14-17 November 2003 will showcase the latest plant and equipment for pharma production, packaging machinery, analytical instruments and biotechnology. For further details, contact: darryl.dasilva@ciionline.org. Pharmacovigilance meeting An international meeting on "Pharmacovigilanceâ€”Promoting Drug Safety Through Collaboration" will be held on 5-6 December in Mumbai. Organized by the Drugs Controller General of India, the meeting will be on the risks and benefits of medicines. The meeting will be preceded by a workshop on Pharmacovigilance. For further details, contact: dcpkem@vsnl.com Chicken Genome Sequence: Impact and Applications symposium The University of Georgia, in association with AviGenics Inc., is organizing a two-day symposium on the science and benefits of chicken genome sequencing entitled "Chicken Genome Sequence: Impact and Applications". The symposium will be held on 13-14 November at the Omni Hotel, CNN Center, Atlanta, GA. It will offer an opportunity to review recent developments in avian genetics and transgenic technologies as well as the impact of avian genome sequencing efforts in diverse fields including the biopharmaceutical industry, poultry industry and food safety. For further information, contact: lawson@avigenics.com Antibody Engineering conference IBC is organizing the 14th annual international Antibody Engineering conference at the Paradise Point Resort, San Diego, CA from 30 November and 1 December. The conference will offer the latest discoveries from basic research to early-stage clinical and how these advances will lead to promising therapeutics. It provides an opportunity to learn the latest in antibody basic science, technology and therapeutic applications. This event is co-located and concurrent with IBC's "Antibody Therapeutics from Clinical Development to Business Strategies" event. For further details, contact: reg@ibcusa.com           ]]> <![CDATA[Happening October]]> https://biospectrumindia.com/news/95/2155/happening-october.html https://biospectrumindia.com/news/95/2155/happening-october.html Wed, 12 Nov 2003 18:21:00 +0530 India's biotechnology sector is beginning to take some small, determined steps forward. Things are definitely falling into places. The actions of four respected biotech companies in the last four weeks provide a clue. First the country's largest biotech company, Biocon India, a privately held company based in Bangalore, decided to make a bold step forward and announce the results of its financial performance in the first six months of the current fiscal. The results would gladden anyone's heart. Its turnover in the first half of this fiscal was a fraction lower than its revenues in the whole of last year. Buoyed by the exports of statins, Biocon posted Rs 259 crore in sales revenues during the April-September period. Boldened by the performance, it has also announced its intention to advance its public offering of equity to early 2004. The company hopes to make few more product releases in the next few months and also announce some major investments. The Hyderabad-based biotech majors Bharat Biotech and Shantha Biotechnics are the next set of newsmakers. Both these companies have launched their recombinant Streptokinase within days of each other's announcement. The blood-clot removing drugs are manufactured using the biotech route and are expected to stimulate this sector. Just as they shook up the hepatitis B vaccine market in the late Nineties as their entries led to the crash of these vaccines imported till then. Today hepatitis B vaccines are sold like commodities. The prices have crashed from a high of Rs 1,200 per dose to an average of Rs 20 now. Another newsmaker is the Bangalore-based bioinformatics pioneer, Strand Genomics. Its latest product, Avadis 2.0, a data analysis and visualization tool, has sold few licenses in the foreign markets and the Technology Development Board of the Department of Science and Technology (DST) is learnt to have given it a Rs 4.6 crore grant to develop and refine the software product. In the investment-starved sector, this is an encouraging development. The icing on the biotech cake is the development of the country's own version of the highly popular Bacillus thuringiensis (Bt) gene by a research team headed by Rakesh Tuli at the National Botanical Research Institute (NBRI), Lucknow. More heartening is the fact that this CSIR lab has catalyzed the formation of a seven-member consortium of seed companies to quickly take the product to the farmer's fields. While it may not compete immediately with the leader Monsanto's Bt gene which has been inserted into cotton crop, the availability of an Indian version of the gene may help to expand the market and also pave the way for a smoother introduction of transgenic technologies. The use of a gene, extracted abroad, into the agricultural products within the country has been a major factor working against this promising technology. Hopefully, the national debate on transgenic products may become less shrill hereafter. It has indeed been a happening October for the fledgling biotech industry in the country. sureshn@cmil.com ]]> <![CDATA[What can BT do for our agriculture?]]> https://biospectrumindia.com/news/95/2525/what-can-bt-do-for-our-agriculture.html https://biospectrumindia.com/news/95/2525/what-can-bt-do-for-our-agriculture.html Wed, 12 Nov 2003 18:12:00 +0530 Our country has gone through 10 technological revolutions since independenceâ€”the green revolution, the white revolution, the DNA technology revolution, the drugs revolution, the computer software and information technology revolution, the space revolution, the atomic energy revolution, the defence technology revolution, the institution building revolution and the telecommunication revolution. The future of the last four of the above revolutions is implicitly linked with biotechnology. It is, therefore, worthwhile looking at what needs to be done to build on our successes in these areas and to plug the loopholes where they exist. This article deals with agriculture that was the target of the green revolution. Let us first look at our 10 successes in agriculture: (1) Our production of food materialsâ€”cereals, potato, sugar, pulses, milk, fish, eggs, meat, edible oil and vegetablesâ€”has increased dramatically (in some cases, up to ten- fold) since independence, during which period our population grew by less than three-fold. (2) There has been a substantial increase in the area under cultivation of high-yielding varieties. (3) A large number of new varieties of cereals, millets, pulses, oilseeds, fodder crops, sugarcane, tuber crops, vegetables and fruits, totaling nearly 3,000, have been developed, released and used extensively in the last 35 years. (4) The hybrid technology has been exploited creatively like in the case of millets, cotton, rice, maize and sorghum. (5) Between 1985 and 1993, we doubled our oilseed production, using a variety of techniques such as exploiting heterosis in mustard. (6) We have increased our cotton production by a factor of four since independence and developed a number of exotic varieties of cotton, such as Suvin. (7) Integrated pest-management strategies have been developed and used successfully for cotton, sugarcane, etc. (8) Systems for conservation and documentation of our plant wealth have been set up. An example would be the National Bureau of Plant Genetic Resources, which has over 200,000 accessions and outstanding facilities. (9) With over 450 million cattle, buffaloes, sheep, goats, pigs and camels, and well over 300 million poultry, we have one of the largest animal wealth in the world. In the last three decades, the production of broilers has increased from one million to 300 million and we have released a number of new breeds of sheep and cattle. (10) We are virtually self-sufficient in respect of animal health products today. Against this background, let us now look at 10 areas where we have missed out and where carefully planned and innovative biotechnology inputs can yield tremendous dividends in the coming years. (I) While the production of rice and wheat has continued to increase, even in other than traditionally high-producing regions of the country, a host of environmental problems, such as soil degradation, a drop in water tables, contamination of water, micro- nutrient deficiencies, and loss of soil carbon, has begun to surface in many regions. This poses two challenges for biotechnology. First, we must find solutions to these problems. Second, bioinformatics must give us ways and means of including the economic cost of such environmental degradation in agricultural cost and price determination. (II) While there has been notable success in integrated pest management, it has been so far confined only to a few areas and crops. It must be extended to larger areas and more crops in a carefully planned way. (III) We must set up an appropriate number of accredited laboratories in the country, both in the public and the private sector, for estimating various chemical and biological contaminants to meet the sanitary and phytosanitary requirements not only for export but also for internal consumption. There is a dearth of such laboratories in the country today. (IV) The high-yielding varieties, e.g., wheat and rice, which were the basis of the green revolution, required large inputs that the rich farmers only could afford. Biotechnology should allow the development of high-yielding varieties using local genetic material that would not require such large inputs. (V) Worthwhile original and pioneering research in areas such as post-harvest science and technology, including decentralized storage; pre-harvest and post-harvest physiology, agricultural and veterinary biochemistry, molecular biology, genetics and pathology (including microbiology and virology); and agricultural and veterinary biotechnology, has yet to take root in most of our agricultural institutions. Research in these areas must be encouraged, as that alone would lay the foundations for increase in agricultural productivity and production. (VI) The socio-economic analysis of the use of energy in agriculture, along with energy-saving mechanisms and strategies for energy management, has not received enough attention at the hands of the scientists in our agricultural research institutions so far. Modern biotechnological approaches should provide us the means to optimize the use of energy in agriculture. (VII) We need technologies for controlled release of fertilizers and pesticides. For instance, our farmers use nitrogen in large quantities, but with the least efficiency. By doubling the fertilizerâ€“nitrogen use efficiency from 40 percent to 80 percent, the world would not only save about $11 billion annually but also help conserve non-renewable resources and improve the environment. Because the non-absorbed nitrogen is not only lost through leaching, nitrification and volatilization, but also leads to environmental contamination such as pollution of ground water. Technologies have already been developed locally for the above purpose but they need to be standardized and improved using modern biotechnology. (VIII) The country does not have a policy for sustainable agricultural development that can increase agricultural productivity per unit time, labor and resources used. The resources, labor and time, thus released, could be used for additional employment that would substantially increase the income of farmers/farm-workers. This additional employment could be provided through biotechnology in areas such as food processing, tissue culture (say, of orchids in Arunachal Pradesh) and cultivation and processing of appropriately-selected medicinal plants. (IX) To ensure that our agriculture remains largely in the hands of our farmers and does not come under the total control of the government-bureaucracy-multinational corporations nexus, it would be essential to invest in R&D of our own in areas such as: exploiting hybrid vigor more vigorously through new scientific approaches than has been done so far; identifying the genetic basis of hybrid vigor and incorporating this information into pure strains, so that the farmer can reuse his seeds with "hybrid vigor"; identifying and using molecular markers for breeding; metabolic engineering (e.g., transferring genes of maize for enzymes such as phosphoenol pyruvate carboxylase/oxygenase and orthophosphate dikinase, into rice for enhancing yield); exploiting the essential natural biodiversity in India; and genetic engineering of plants coupled with stringent risk assessment done in a professional, unbiased, ethical and transparent manner. (X) We need to invest a great deal more in studying, validating and then utilizing the validated traditional agricultural practices such as water harvesting and organic farming. PM Bhargava   ]]> <![CDATA[BioSuppliers - A niche opportunity]]> https://biospectrumindia.com/news/95/2828/biosuppliers-a-niche-opportunity.html https://biospectrumindia.com/news/95/2828/biosuppliers-a-niche-opportunity.html Wed, 12 Nov 2003 17:43:00 +0530 In the fiscal year 2002-03 the Indian biotech industry grew to Rs 2,300 crore. With this significant growth in the biotech industry, the BioSuppliers market has also opened up. The total size of this segment is Rs 475 crore and there are about 25-40 key companies supplying biotech products to India. The sector is seeing a lot of activity and is abounding with opportunities for people from diverse backgrounds. Employer Expectations Qualification Manufacturer of engineering equipments: Chemical/Biochemical/Biotech engineers. Manufacturer of consumables: MSc/PhD in biochemistry, biotechnology, microbiology or related life science fields, MSc Agriculture, MVSc, etc. Distributors and suppliers: MSc/PhD in relevant branch of biological science and having strong sales and marketing background Selection Procedure Inviting resumes through advertisements, screening and short-listing and then interviews Selection Edge â€¢ Sound scientific skills â€¢ Good subject knowledge â€¢ Process knowledgae â€¢ Engineering knowledge â€¢ Innovative ideas â€¢ Time bound actions â€¢ Result orientation â€¢ Decisive power â€¢ Confident attitude with good communication skills â€¢ Experience desirable but not a must Training Specialized training provided in-house "The potential for BioSuppliers is increasing and the growth rate expected is around 13 to 15 percent. This is directly related with the biotech R&D and products for which equipment are required. The field calls for hi-tech, hygienic standard equipment for the industry. The opportunities will increase slowly by 5 to 7 percent and by 2005 the rate will be substantially high," said MT Rananaware, DGM-Life Science, Alfa Laval (India) Ltd. "The segment is growing at over 40 percent and the opportunities are very good" remarked Arun Prakash, CEO, Genetix Biotech Asia. "This sector offers good growing opportunity for graduates/post graduates with bio or chemical engineering background with a couple of years of experience in a lab or industry. The trend is towards higher educational qualification in addition to basic sales and marketing skills," said senior managers from Amersham Biosciences Many major companies like Agilent, Alfa Laval, Amersham Biosciences, BioRad, Cambrex Chemicals, Kendro, Millipore, Sartorius, Thermo Electron, Waters India and others have set up their subsidiaries in India and are supplying equipment on a large scale to the Indian biotech industry. Besides, there are Indian companies like Ace Instruments, Andel Equipment, Bangalore Genei, Biotech India, Genetix Biotech Asia, Life Technologies, Pharmalab, Praj Industries, Span Diagnostics and Toshniwal Instruments, which are manufacturing/supplying key equipment, consumables, etc., to the biotech sector. Depending on whether the company is dealing in generic or high-tech products, equipment, consumables, disposables, etc., the profile of required candidates may vary from company to company. As Dr P Babu, CEO Bangalore Genei, aptly puts it, "BioSuppliers could be both trading companies and manufacturers. Further biosuppliers could be based on the nature of equipment/instruments or reagents, enzymes etc., so it is difficult to group all the biosuppliers together. The segment is more niche unlike biopharma/bioagri." If the company is primarily into manufacturing, like Alfa Laval, which is one of the leading manufacturers of engineering equipment and supplier of complete plants, then the main job functions will be pre engineering of the processes and products, preparing specifications and drawings, procurement and execution of projects with documentation. Accordingly, the company will look out for chemical/biotech engineers. Similarly if the core competency of the organization is making reagents, diagnostic kits, enzymes, etc., then it will require candidates possessing post graduation or doctorate degree in biochemistry, biotechnology, microbiology or related life science fields. And if the company is a distributor of biotech products then it will require candidates having sound technical knowledge about the products along with strong sales and marketing background. "This sector offers good growing opportunity for graduates/post graduates with bio or chemical engineering background with a couple of years of experience in a lab or industr Cambrex Chemicals, a 100 percent subsidiary of the US based Cambrex Corp., assists the biotech industry in maintaining its product quality and also supplies ingredients used by the research institutions to develop new products. "The job categories are business managers, technical service managers, etc. We require graduates with a basic biological background and any additional qualifications would add value. The candidates should possess integrity, team-playing capability and the ability to work independently," said Vivek Varma, business manager, biotherapeutics, Cambrex Chemicals. "At Genetix the job categories are business development executives, product specialist and customer care representatives," said Arun Prakash of Genetix. The company offers marketing and technical support to biotech and life sciences companies. "The qualifications required are MSc (for business development executives), PhD for product specialist (males/ females), graduates with computer skills for customer care representatives (females)," he added. In Amersham Biosciences, which is a leading global provider of biotech systems, products and services used in gene and protein research, drug discovery, development and biopharmaceutical manufacturing, the different levels of jobs throughout the organization range from product specialists, area manager, product manager, sales manager, application specialists, service engineers and service managers. "We have defined key responsibilities and accountability for each position/functions. For example, a sales person or product specialist would assist in product management, key account management and be responsible for conducting seminars and demonstrations to customer. Good communication skills, teamwork, self-motivation, perseverance, technical skills and a positive attitude are a few things we look for in a candidate. Candidates with exposure to the western scientific arena are also welcomed," said senior managers from Amersham. "India will emerge as a strong player in this sector soon" "Today the biosuppliers are making a hay day with supplies to Indian market with imported goods. This needs to be reversed, if biosuppliers are to make a contribution to the economy of the country. Exports in the engineering and software fields can grow tremendously in the coming years. Engineering support as a BPO for several companies outside is also a large potential area to be tapped. I am confident India will emerge as a strong player in this sector very soon." In response to some questions posed by BioSpectrum on careers in the biosuppliers segment, Dr Anil Paul Kariath, managing director, Sartorius, replies: What is the potential or opportunity for the BioSupplier segment? The biotech industry itself is in a nascent stage in India and offers huge potential for equipment support and ancillary industries. This opportunity should also be seen as a platform to showcase excellence in Indian engineering expertise for the world biotech market and not only for Indian market. What are the job categories, job functions/responsibilities in your company? Ours is primarily an engineering hardware business. The job categories pertain to design engineering, fabrication engineering and process engineering. The core responsibility is of technology management and its application for cost-effective solutions matching developments in R&D sector. What do you look for in your potential employees? Do you insist on hands-on training or experience? Qualification wise we require engineering and biochemistry graduates having sound technical knowledge and managerial skills. Hands-on training/experience is desirable but not a necessary condition. But, demonstration of individual skills and initiatives can give a definite edge in the selection process. What is the procedure of employee selection? We follow structured recruitment through a print media campaign. What are the growth prospects and salaries of people involved? The growth prospects of our employees are commensurate with growth of the industry and the salaries meet the industry standards. How many employees are there in the organization and what is the manpower: womanpower ratio? In all there are 190 employees and the manpower: womanpower ratio is 10:1. "In general, we look for candidates with a MSc or PhD degree in bio-related fields like molecular biology, biochemistry, chemical engineering, etc. A couple of years of either sales experience with a similar company or a couple of years of research experience in a lab or industry is a requirement. Specialization is a particular area is a definite plus. Being a technology-intensive company, a couple of years of either research or sales experience is a must," they added. "As the range of products one deals with is enormous especially reagents and chemicals, a person needs a good bio background to understand this. Our company believes in not just selling a product but in helping the customer complete his entire research process successfully using our products. Therefore, it is essential for the employee to have a scientific mind and a good rapport with the customer." Amersham presently has 50 employees all over India, about 20 percent of its workforce comprise of women and their number is gradually increasing. Wipro Health Science is one of the top service providers, offering both IT solutions and supplying equipment to the biotech industry. According to Wipro officials, "at present the job categories are consultants, solution architects and software engineers and also biochemists in the future. The job functions are conceptualizing, designing and delivering solutions to research laboratories in industry and academia. Wipro is also setting up a reagent kitting setup to deliver reagents for its hardware solutions at a better price". "The procedure for selection is recruitment either through manpower consultants (for more senior roles) or walk-in interviews (for junior roles). The qualifications required is laboratory background with masters or greater for consultants and BE+ for software delivery. We look for technical skills, customer focus and ability to envision solutions. Additionally, there are internal Wipro criteria for each hired person. Better communication skills and an ability to listen and comprehend what is being said clearly can give a definite selection edge, " they added. "Although internally there is a full-fledged training process and training courses on both technical as well as soft skills but it helps if the candidate has prior laboratory expertise and experience." Wipro is not currently recruiting but sees considerable scope in the next year. "The biosupplier segment is more niche unlike biopharma/bioagri" Bangalore Genei Pvt Ltd has been operating in the space of product manufacture for genetic engineering and molecular biology for the past 14 years. It is one of the leading manufacturer of enzymes. Dr P Babu, CEO, Bangalore Genei gave Biospectrum a feedback on careers in this growing industry. What are the key characteristics that you look for while selecting an individual? The primary job categories at Bangalore Genei being lab technicians and scientists, so the main qualities we look for are good scientific skills. The qualifications usually needed are MSc/PhD in biological sciences. We also look for bright graduates and candidates qualified in related areas such as MSc Agriculture, MVSc, etc. We do not insist on experience or prior training in specific courses. Competence is more important. What is the procedure of manpower selection? Do you go to campuses for recruitment? We usually advertise and based on the response, we shortlist the candidates for interview. We sometimes do conduct campus interviews, however this is rare. What is the total number of people in your company and what is the manpower: womanpower ratio? There are around 90 employees in our organization, out of which 50 are scientifically well qualified. In our laboratory the womanpower ratio is more, in sales manpower is more. Do you offer any technical training course for graduate/postgraduate students for better orientation/awareness towards the industry? We offer training for four days, which involves hands on training for students to get a better feel of molecular biology as well as immunology. sInviting resumes through advertisements, screening and short-listing of the candidates, and then interviews is the general norm practiced by most companies. "Procedure followed for manpower selection is interviews and written test followed by personal interaction with the candidates to check his IQ level and expectation," said MT Rananaware of Alfa Laval. "The key characteristics we look for are process knowledge, engineering knowledge, innovative ideas, time bound actions, result orientation and decisive power," he added. In any company sound scientific skills, good subject knowledge, creative thinking and a confident attitude with good communication skills are the key attributes, which facilitate selection. Prior experience and training is desirable but not pre requisite criteria in most companies. Major tool providers Ace Instruments Agilent Alfa Laval Amersham Andel Equipments Axygen Scientific Bangalore Genei Becton Dickinson BioRad Biotech India Cambrex Chemicals Genetix Biotech Asia Kendro Labvantage Solutions Life Technologies Millipore Pall Pharmalab Praj Industries Sartorius Span Diagnostics Thermo Electron Toshniwal Waters India Wipro Many organizations dealing in specialized products generally provide in-house specialized training from time to time. Genetix provides short-term in-house and overseas training programs to improve job competency. "A higher qualification in biological sciences can provide an edge in the selection process. As the products are technical in nature and require continuous upgradation, so training programs are conducted from time to time," remarked Vivek Varma of Cambrex Chemicals. The growth potential for employees is excellent. Plenty of opportunity is available for growth within India and internationally too. "We are around 700 employees, for bio process department we are 13 and expected to grow to 20 by year end 2004. Depending on our growth of business, we may plan to recruit next year," said MT Rana-naware. "The opportunity in the BioSuppliers segment is growing and in a manufacturing company like ours, there is a huge growth potential," commented Dr Babu of Bangalore Genei. "The person can become the head of his/her respective department along with improvement in job competence and personality development through good working environment and training programs," said Arun Prakash of Genetix. Vivek Varma of Cambrex Chemicals also made a similar comment, "candidates can head the unit as a business manager." Many companies like Genetix, Amersham and Cambrex Chemicals plan to increase their workforce in the near future. Rolly Dureha ]]> <![CDATA[BD India - Accelerating biomedical discovery]]> https://biospectrumindia.com/news/95/2673/bd-india-accelerating-biomedical-discovery.html https://biospectrumindia.com/news/95/2673/bd-india-accelerating-biomedical-discovery.html Wed, 12 Nov 2003 17:33:00 +0530 Becton Dickinson and Company (BD), a BioSpectrum Top 20 company caters to a wide range of needs of the pharma industryâ€”drug discovery, drug delivery, diagnostics etc. This US-based company is engaged principally in the manufacture and sale of a broad range of medical supplies, devices, laboratory equipment and diagnostic products used by healthcare institutions, life science researchers, clinical laboratories, industry and the general public as well. BD operates in India through a wholly owned subsidiary known as BD India Pvt Ltd. BD has a manufacturing facility in India, a highly automated plant at Bawal, Haryana. This facility produces products like disposable needles, syringes and catheters, which are recognized all over the world. Its manufacturing techniques confirm to international standards and the factory has been recognized by the Haryana State Industrial Corporation. The products manufactured by the company are sold worldwide. The major markets for BD outside the US include Europe, Japan, Asia Pacific, Canada and Latin America. BD Business Segments BD operations consist of three worldwide business segments: Medical Systems, Clinical Laboratory Solutions and Biosciences. Medical Systemsâ€”The major products in this segment are hypodermic products, specially designed devices for diabetes care, prefillable drug delivery systems, infusion therapy products, elastic support products and thermometers. This segment also includes disposable scrubs, specialty needles and surgical products. Clinical Laboratory Solutionsâ€”The main products in this segment are clinical and industrial microbiology products, sample collection products, specimen management systems, hematology instruments and other diagnostic systems, including immunodiagnostic test kits. This segment also includes consulting services and customized and automated bar-code systems. Biosciencesâ€”This segment provides integrated systems, products and services for a variety of applications in life sciences. The major products are flow cytometry systems for cell analysis, monoclonal antibodies for biomedical research, molecular biology reagents for the study of genes, cell growth and screening products and labware products. Headed by an active general manager, Sunit Trivedi, BD Biosciences is growing at a fast pace. Explaining about the biosciences division of the company, Sunit Trivedi said, "Through this division we are spreading awareness in the industry. As one of the largest business supporting the life sciences worldwide, BD biosciences provides biotechnology tools, leveraging the expertise in molecular biology, immunology and cell analysis. Conducting seminars and workshops is also a part of our mandate." Elaborating on the company strengths he said, "Our understanding about the research industry is our key strength. At BD Biosciences, we know what exactly the industry needs." "We are committed to the highest standards of excellence in everything that we do. I am proud to work for a healthcare company whose products and services make a difference in people's lives. We derive our greatest sense of accomplishment from doing what is right and not what is expedient." Sunit added. Regional manger for technical support in the Asia pacific region, Dr Arvinder Singh is satisfied with the kind of services and relationship they have with their customers. He said, "We are targeting a very niche market. Since the market that we are catering to, is not very huge, we need to focus on our customer a lot. Through our after sales services, we understand their needs and cater to them accordingly. Sustaining customer relationship by providing quality service is a vital aspect for growth. We are doing this in a good way." BD biosciences The biosciences segment of Becton Dickinson (BD), has been built on BD's 100-year foundation of commitment to its customers and business partners around the world. It has expertise in molecular biology, immunology and cell analysis along with the biotechnology tools. With four business units-Clontech, Discovery Labware, Immunocy-tometry systems and Pharmingen, BD Biosciences provides integrated high-value products and services for a variety of applications in the life sciences sector including genomics, proteomics, ADME/Tox, oncology and immune function. The customers of the company include academic and government institutions focused on basic and clinical research in life sciences, biotech and pharma companies engaged in drug discovery and development, hospitals, reference labs and blood banks. Clontech As a leader in molecular biology, Clontech provides research reagents and assays kits with applications for genomics, functional genomics, proteomics and drug discovery. Major product brands include BD AtlasTM, BD Living colors and MatchmakersTM. Discovery Labware As a leader in engineered labware products, Discovery Labware provides products and services with applications for drug discovery and development, ADME/Tox, cell, tissue culture and fluid handling. Major brands include BD Falcon TM, BD Biocoat TM and BD Gentest TM. Immunocytometry systems As a leader in immunology and cell analysis, Immunocytometry systems provides flow cytometry systems for research and clinical use with applications for immune function, vaccine research, infectious disease and oncology. Major product brands include BD FACSTM, BD FACSCaliburTM, BD FACSVantageTM SE, BD TruCOUNTTM and BD OncomarkTM. Pharmingen As a leader in research immunology, Pharmingen provides biomedical research reagents and kits with applications for cell biology, immunology, molecular biology, oncology, proteo-mics and signal transduction. Major product brands include BD PowerBlotTM, BD RiboQuantTM, BD Cytometric Bread Array (CBA)TM, BD PharmingenTM, and BD Transduction LaboratoriesTM. In addition, Pharmingen offers BDTM ELISPOT reagents and BDTM Monoclonal Antibodies. "Emerging R&D in corporate, a good sign for industry" It was an achievement of sorts for BD India's Biosciences division, when they established India's first ever flow cytometry training center this year. BD is running smoothly and creating its own market under a very niche umbrella. This and lot more has been achieved under the leadership of Sunit Trivedi, general manager, BD Biosciences. And after meeting him one can easily realize the immense potential of his team, which can achieve much bigger goals. In an exclusive interview with BioSpectrum Sunit Trivedi introduces his company and highlights the future plans. What is the status of drug research in India? What is the role of BD Biosciences in this field? With the new patent regime in 2005 approaching fast, the Indian companies are in the process of gearing up their R&D facilities. The drug discovery market is getting huge day by day. Opportunities are flourishing into the Indian market and all we need to do is tap the market. In this field, the initiative of BD Biosciences is now well known. We have recently opened a flow cytometry training center. Flow cytometry forms the basis of many research works and is an integral part of drug and vaccine research for diseases like leukemia, AIDS and stem cell therapy. This center can be seen as the pioneering step towards self-reliance in drug research in India. How is the response from the research community and industry towards the flow cytometry initiative? Until now, the Indian scientific and research community had to undergo a long training procedure abroad for proper understanding of the technology applications. Given the complicated nature of the technology, any new innovation in the product would have necessarily resulted in re-training of the community. This involved vast fund and time investment. With the launch of the training center all such impediments can be addressed effectively and promptly. By paying nominal charges any interested scientist can get the training and perform his or her research work. This short time training program lasts for few days and the fee is also not very high. As of now, 25 to 30 scientists have completed their training. They represent not only the research institutes but also the leading pharma companies. What growth target have you put for yourself, especially in the flow cytometer market? The flow cytometer instrumentation market is small. Infact, it would not be wrong saying that BD has driven this market. Investment is high in establishing a flow cytometer lab. The automated flow cytometer instrument comes for about Rs 2.5 crore. But with the kind of response shown by the industry and research community we are confident of its success in the near future. As far as target is concerned, we would be satisfied if we sell 3 - 4 flow cytometers in a year. There is an increased emphasis on R&D all over the world. What is the trend in the Indian market? The status of R&D is getting better and better. Industry is participating in a big way. A lot of pharma companies are taking up serious research and development work. But the money earmarked for R&D in India is low as compared to that in other parts of the globe. With the advent of pharma companies into R&D, the future scenario seems to be more biopharma-based. Apart form this, bioresearch holds a huge potential and this segment is becoming a great market in India. What is the role of the Indian government in this sector? It is nice to see that the government is playing an effective role in building a strong base for the industry. Initiatives taken by the government are considered good by several MNCs and big corporates. All these are good signs of growth. But what is needed is to keep up the pace and sustain the speed of growth. This will be possible when we always keep self-examining ourselves. What are challenges and hurdles ahead of the industry? I think there are some hurdles, which are acting as speed breakers on the road of Indian industry growth. Among them, high duty charge is the most important one. Due to high duty we cannot bring our products in the competitive price range. Apart from this, the bureaucratic hurdles should also be look into. The factor, which is affecting the business, is time consuming formalities. I think these are the few major constraints, which are affecting the industry in a negative way. How is the current performance of the company? What are your future plans? We are growing at an average of 20 to 22 percent every year. And we a working towards continuing with the same growth rate. The company had a turnover of Rs 95.34 crore in the last fiscal year. And the company is expecting substantial growth by the end of this fiscal. BD Biosciences is catering to a small and niche segment and has a lion's share, of about 95 percent, of this segment. We can say that we the drivers of our segment and hence the leaders. What is the driving force at BD which makes the company grow? We consider individual involvement and accountability to be both a right and a privilege and accept personal responsibility for everything that we do. We treat the company's reputation as our own and try to make wise use of our time and the company's resources. ]]> <![CDATA[CDRI - Beautiful lab, Serious work]]> https://biospectrumindia.com/news/95/7949/cdri-beautiful-lab-serious-work.html https://biospectrumindia.com/news/95/7949/cdri-beautiful-lab-serious-work.html Wed, 12 Nov 2003 16:39:00 +0530 CDRI is considered a pioneer research organization in the field of biomedical research. It has the infrastructure and expertise to develop a drug right from the concept stage to the market. The institute's latest techniques and services are employed for developing drugs, diagnostics and vaccines to combat diseases prevalent among mankind in general and Indian population in particular. Dr CM Gupta, director CDRI, who did his PhD from the institute itself said, "I am really proud to be a part of such a multidisciplinary research laboratory consisting of scientific personnel from various areas of biomedical sciences. The manpower at our institute has been grouped into 17 R&D divisions and a few divisions providing technical and scientific support." He added, "in a country like India, there should be no research work without industry collaboration. In my view, industrial collaboration and industry feedback are some basic things for any successful product." This is another reason for CDRI's success in the industry. Explaining about the future prospects of the institute he said, "Achieving excellence in drug discovery through modern tools and techniques is among our core focus areas. We also have a strong commitment towards exploiting natural resources so that the problem is approached holistically and multilaterally along with multifaceted infrastructure developments. Taking CDRI to the global platform is also on our mandate. With the facilities available here, we can become a world-class research institute in drug discovery." CDRI envisages discovery of safe and better drug molecules in the area of tropical/infectious diseases and age related degenerative disorders. There is also a proposal for creation of a "World Class Drug Research Institute" in the new research premises at Sitapur Road, Lucknow. The vision of this new drug research institute is to discover and develop new chemical entities for diseases of national priority and lifestyle and age related disorders. The new institute would have R&D labs conforming to the current and emerging international standards, a flexible organization structure comprising of only three major divisions viz. biological sciences, chemical sciences and pre-clinical sciences. In the institute the leadership positions at all levels will be merit based with an in-built stringent mechanism for assessing and monitoring projects. To keep abreast with the global developments, CDRI is conducting an international symposium on "Global Trends in Drug Discovery Research". This symposium will not only provide a platform for interaction between chemists and biologist but it will also address the challenges of the post-genomic era. "Industry participation is very important for research" - CM Gupta At the time of independence, when the major challenge facing India was increasing population, a newly opened CSIR lab took the responsibility of furthering scientific research and development. Now, after more than 50 years, this CSIR lab has made a name for itself not only in India but abroad as well. The Central Drug Research Institute, Lucknow, has not only formulated successful market products but also nurtured key people, who are driving the present Indian pharma industry. Now, with the help of new techniques and tools, the institute is equipped to spearhead the Indian biopharma industry. This has been possible because Dr CM Gupta, director CDRI, has firm faith and belief in the industry. He said, "I don't think that any research can become successful without industry collaboration." A strong believer of taking science into the market, Dr Gupta is satisfied with CDRI's initiatives and efforts. In an exclusive interview with BioSpectrum, he shared some facts and his upcoming plans for the institute. CDRI has achieved a big name in drug discovery, what are the next targets and how is the institute working towards those? The institute was started when India had no pharma industry. The focus of the institute at that time was different. We were more inclined towards problems like birth control and producing technical manpower for the Indian industry. We achieved these goals quite some time ago. Now, with the advent of biotech tools, our institute has also developed its skills. With the help of biotech applications we now have world class facilities for research work. Combinatorial chemistry is one of them. Combinatorial chemistry has emerged as a powerful tool for accelerating the drug discovery process. Compared to traditional drug discovery approach, which requires many days of work to synthesize and analyze a single new compound, combinatorial chemistry can produce and screen thousands of compounds in weeks for the discovery of novel drug entities against various disease targets. Apart from this, high throughput screening system, X-ray crystallography and proteonomics are among the upcoming areas of research at our institute. What are the areas of research on which your institute is focusing these days? There are several focus areas on which we are doing research. Among them the major ones are reproductive health, new drug discovery for birth control, breast cancer, tropical diseases, diabetes and cardio vascular diseases. In new drug development research, our mandate is to explore our own traditional strengths applying some modern tools. For malaria, we have developed two drugs. E-mal and Aablaquin are the two most successful drugs developed so far for curing malaria patients. We are also in the final stages of research for producing a drug for tuberculosis. What is CDRI's experience in collaborating with the Industry? Our experience in this line is tremendous. We have expertise in signing MOUs with the industry. I strongly believe that every research work should be collaborated with the industry. Research should be done along with them. Industry feedback is important for us. It is better to have a joint project because in certain researches the risk factor is high. Why are some corporates and MNCs still hesitating in collaborating with government research labs? Industry participation in research work is good. Lot of companies are getting attracted towards India because of its knowledge resource, etc. But the process of filling up certain formalities is time consuming. This needs to be reduced. I have always recommended that this time should be cut short. These time consuming formalities make them uncomfortable. As far as MNCs are concerned, we have some European companies as collaborative parties, who are showing good involvement in the project. We review our research every three months. Why is there no database of patients available in our country? How much can this help in discovering a new drug? There are some facts and figures, which show India's health scenario. But if a country like India maintains records for specific diseases then it would be very helpful for doing further research. Diabetes is a big challenge for India. If we would have had the database with us, we could produce new and more effective drug in less time. Going through records is essential for any drug research as it helps in limiting the side effects of that drug. Which are the new products in the CDRI pipeline? We are working on antibreast cancer drugs, antimalaria, antiTB, antidiabetes and few others. How is Memory Plus doing in the market? Memory Plus is one of our key products. Unfortunately, we faced some problems in dealing with the company to whom we had given the marketing rights earlier. But now we have signed a new agreement with Promind for its marketing license. A Canadian company is also approaching us for its marketing rights abroad. But I cannot disclose the name as the agreement is yet to be finalised. Since you are going to retire from the director's post in coming year what are your projections about CDRI's growth rate? I am happy to be associated with CDRI since such a long time. With the kind of qualitative workforce we have, the growth rate will definitely be good. But we need to focus on newer trends. We need to have farsightedness, which would help us in tapping new areas of research. And that would help us in reaching our targets. Dr Zaka Imam, a deputy director of the institute and head, technical information said, "research activities at CDRI are aimed at developing drugs, diagnostics and vaccines to cure and get rid of the ailments confronting mankind in general and Indians in particular. The R&D activities of CDRI have been categorised in various research areas. Each research area is focused on the design and development of drugs, diagnostics/vaccines related to a particular disease group right from the synthesis of compounds upto regulatory studies and clinical trials." Another area of focus is the regulatory studies. "Since, we claim to offer total drug discovery tools and take the drug from the lab to market, we need to focus on the regulatory measures of the country. To launch any new drug we need to have proper understandings of the regulatory tools," informed Dr Gupta. CDRI focuses on developing new drugs, diagnostics, vaccines and modern technologies for clients in India and abroad. "We always look forward to have close commercial relationship with the pharma industry and other R&D organizations involved in biomedical research. Through such collaborations we want to develop a strong drug research base in the country and make India a stronghold in biomedical research. We offer collaborative as well as contract commercial opportunities in these areas," elaborated Dr Gupta. Apart from these services, CDRI also offers contract research. "We undertake contract research work as per the requirements of the contracting party and/or as identified by industry/laboratory. We also undertake research, if completely funded by the collaborating organisation or industry." Among the major facilities available at the institute is the High Throughput Screening System. Dr Sudhir Sinha, assistant director, biochemistry division CDRI, heads this lab. Informing about the facility Dr Sinha said, "The main objective of establishing this facility is doing in vitro screening of chemical libraries and natural products in an enzyme/receptor based assay. Identification of new structural prototypes for drug development is also on the mandate. Apart from this, adoption of screening models for HTS in whole cell based assay is also one of the objectives." "Removing non essential work is a vital demand in doing any type of research. We have the tools to shorten the research time through this facility," he added. X- ray crystallography is another facility available at CDRI, which can hasten research. Dr Ravishankar Ramchandran, the lab head said, "we are in the process of finding protein crystals. Infact, the industry needs such tools and efforts. Through this we can design inhibitors and new molecule." "Determining the three dimensional structure of a protein and its mode of interaction with a ligand/inhibitor is a key step in the drug discovery pathway. CDRI has the facility for collecting diffraction data from both protein and small molecule crystals," he added. "The macromolecular data collection facility consists of a MAR345 area detector mounted on a RIGAKU rotating anode. The data collection is automated and controlled by a computer while the small molecule data collection facility consists of a modern BRUKER-AXS system. Structure solution, analysis and novel inhibitor design is facilitated by graphics intensive workstations of Silicon Graphics Inc," he informed. CDRI has formulated many health products, which are been successfully marketed in India and abroad also. After filing the first patent in 1960, the institute has never looked back. It has filed about 650 patents and continues to file 30 to 35 patents per year. Around 1,100 students have been awarded PhD from CDRI so far and currently the institute produces 20-25 PhD scholars every year. ]]> <![CDATA[Blockbuster US patent expiries, 2002 - 2007]]> https://biospectrumindia.com/news/95/1839/blockbuster-us-patent-expiries-2002-2007.html https://biospectrumindia.com/news/95/1839/blockbuster-us-patent-expiries-2002-2007.html Wed, 12 Nov 2003 16:35:00 +0530 Source Source: From a presentation by Peter Brazier, BIS Executive, Life Science, IBM Asia Pacific on "Pharma 2010: The Threshold of Innovation". ]]> <![CDATA[Bt cotton - The debate continues]]> https://biospectrumindia.com/news/95/3510/bt-cotton-the-debate-continues.html https://biospectrumindia.com/news/95/3510/bt-cotton-the-debate-continues.html Wed, 12 Nov 2003 16:23:00 +0530 It may be noted that BioSpectrum was not a part to any of the findings and does not have any stand on the issue. Bt MECH 12, Bt MECH 162 and Bt MECH 184 were the three transgenic varieties approved by the regulator, GEAC and the period of validity of approval is three years from April 2002-March 2005. As of now, it is premature to give a verdict on the performance of Bt cotton in any part of India. Its performance can be judged only at the end of the validity period, when there would be adequate and reliable data to do so. Gene Campaign report The Gene Campaign report was compiled by Dr Suman Sahai and Shakeelur Rahman. Gene Campaign's methodology of survey The Bt cotton varieties compared by Gene Campaign were Bt 162 and Bt 184 belonging to Mahyco-Monsanto and the non-Bt cotton varieties were the local hybrids "Brahma" and "Banny". This field study was done on the basis of data obtained from the first commercial Bt crop. The survey was conducted in selected locations in Maharashtra and Andhra Pradesh, which are two of the six states that have been granted permission to commercially cultivate Bt cotton. The survey included a total of 100 farming families selected by random sampling from those who had chosen to grow Bt cotton on a portion of their landholding. These farmers were also growing non-Bt cotton simultaneously. Of the total of 100 families surveyed, 25 were from Maharashtra and 75 from Andhra Pradesh. Scientists from the Agricultural University in Hyderabad accompanied the Gene Campaign researchers. The study compared the performance of Bt to non-Bt cotton. It found that Bt cotton is not performing well and is in fact lagging behind the normal cotton in many respects. The study showed Bt cotton to be a shorter duration crop (90-100 days) than non-Bt cotton (100 to 120 days) but the plants showed less vigorous growth, with fewer branches and smaller leaves. A major problem reported was the premature dropping of bolls in Bt cotton. A comparison of bolls and fibre showed that the number of bolls per plant was higher in the non-Bt cotton variety. Whereas the non-Bt variety averaged 95 bolls per plant, in the Bt variety the average was only 50 bolls. Fibre length was also longer in the non-Bt varieties, which had better grade cotton. Non-Bt cotton was graded as A and B quality whereas Bt cotton was graded as B and C. Although both cotton types demonstrated a range of small to large bolls, more Bt cotton bolls were of a smaller size than the non-Bt cotton. A significant finding of this study was the indication that Bt cotton variety does not offer protection against pink bollworm (Pectino-phora gossypiella). Pink bollworm attack was found to be severe after 60 to 70 days. There could be two possible reasons for this. The first could be that the period of expression of Bt endotoxin does not coincide with the time of the bollworm attack. This would mean that when the pest attacks the cotton, it is not expressing the endotoxin gene and therefore not offering any protection against the pest. The other explanation could be that the pink bollworm is not susceptible to Bt endotoxin. The pink bollworm in India has probably developed resistance after being exposed to Bt toxin from the field trials that have been conducted during the past years and from the use of Bt pesticide sprays. Economics of Bt cotton cultivation The study stated that the economics of cultivating Bt cotton was not in favour of farmers. The seed being four times more expensive than the good local hybrids. The difference in the price of seed is approximately Rs 1200 per (450 gm) bag, which is needed to plant an acre. Comparison between bolls and fibre of non-Bt and Bt cotton Item Non-Bt Bt Number of bolls/plant 95 (70 - 120) 50 (25 - 75) Boll size 6 - 8 gm 3.5 - 5 gm Fibre length 34.5 mm 30.5 mm Cotton Quality (grade) A & B B & C As against this outlay, savings on pesticide were meagre, averaging Rs 217 per acre. Thus the investment per acre is much higher for Bt cotton than for non-Bt cotton varieties. The Bt cotton farmer had to invest on average, Rs 983 more per acre than his non-Bt counterpart. And the average yield per acre of Bt cotton in all categories of landholdingsâ€”low, medium and high, was found to be poor when compared to its non-Bt counterpart. The result was that the net profit from Bt cotton was lower per acre compared to non-Bt cotton in all types of fields (low to high yielding). The study pointed out that in fact, 60 percent of the farmers cultivating Bt cotton were not even able to recover their investment and incurred losses averaging Rs 79 per acre. The performance of Bt cotton in the areas studied in Maharshtra and Andhra Pradesh was poor and the farmers have had to suffer losses. Not surprisingly, an overwhelming majority of the farming families surveyed (98 percent) said they were not interested in growing Bt cotton again. Comparative income from Bt and non-Bt cotton Non-Bt cotton Bt cotton Farm Type Farmers (%) Income/acre (Rs) Net Profit/ acre (Rs) Farmers (%) Income acre (Rs) Net Profit/ acre (Rs) Low Yielding 35 7394 2661 60 5637 -79* Medium Yielding 58 12512 7779 35 9737 4021 High Yielding 7 20475 15742 5 15375 9659 Findings of C Kameshwar RaoAnother survey on the performance of the first commercial standing Bt cotton crop was done by Dr C Kameshwar Rao, a botanist and executive secretary, Foundation of Biotechnology Awareness and Education last year. His overall impression was that the Bt cotton variety, Boll Guard MECH 162, is performing well providing an effective control of the cotton bollworm. It should be mentioned that Dr. Rao had visited five fields and observed that one's visit of a few fields could not be the basis to generalize the situation in the entire state of Karnataka but nevertheless serves as a good indicator of the situation. Methodology Dr C Kameshwar Rao visited five cotton fields, near Ranibennur (central Karnataka), along with a team of cotton breeders and scientists in September 2002. They visited one irrigated Bt cotton field at a farm of Mahyco, the licensee of Monsanto to market Boll Guard, the Bt cotton seed, in India. They also visited three other Bt-cotton fields (one of them irrigated) and neighbouring these, two non-Bt cotton fields. These five belonged to farmers. All these five fields are small, each about an acre, and the crop was about 80 days old. The varieties of Bt and non-Bt cotton in the neighbouring fields were not the same. One non-Bt was Indo-American Hybrid seed and the other was Brahma, while the Bt cotton was MECH 162. He observed that Bt cotton plants were more vigorous and early maturing at least by two weeks compared to the non-Bt refuge plants in the same field. A farmer told him that the yield was about 40 percent more than his past experience with the non-Bt cotton harvest and was full of praise for Bt cotton. Th farmer had applied only two sprays of insecticides for the sucking insects and one spray for the bollworm and hence saved a lot of money in terms of pesticide costs, which would have been incurred otherwise. He planned to pick cotton till March 2003, which was not possible with non-Bt cotton, all these years. Dr Rao observed that in the neighbouring non-Bt farms, farmers had applied two sprays for sucking insects and five sprays for bollworm and still there was heavy infestation by bollworm. At this rate the farmers would be spraying insecticides about a dozen times more by the end of the cropping season. Due to this the resulting loss of yield would certainly be more than 20 percent and may even be 40 percent. He observes that there is propaganda regarding a fall in the yield of Bt cotton. Boll Guard was never projected for improved yield. Whatever higher yield the farmers get is due to prevention of loss rather than improved performance of Bt-cotton in terms of yield. He counters the claim that since even Boll Guard needs insecticide spray, it is a deceitful introduction. Boll Guard is effective only against the bollworm, which is the principal pest responsible for the loss of the end product, which is the cotton fibre. The sucking insects damage the leaves and this would certainly reduce the yield to an extent but they are not as damaging as the bollworm, as they do not affect the economic product directly. Insecticides need to be sprayed against pests other than the bollworm and the difference of insecticide use between non-Bt- and Bt-cotton is very significant. These two survey studies project very different outcomes for the Bt cotton crop. The need of the hour is a reliable independent body, which can study the performance of Bt cotton systematically and give relevant field data over the three-year validity period. The data then needs to be analyzed by scientists on various parameters before forming the basis for any judgement. But in spite of the opposing views of the reports, both point out some basic problems, which need to be taken care of. No Training for Farmers Gene Campaign examined if any pre cultivation training or technical assistance was given to the farmers by any of the government agencies or Mahyco-Monsanto. They found that neither state nor central government agencies had provided any training. The seed company had made available pamphlets showing that spraying had to be done on Bt cotton if number of pests exceeded a certain level. In the absence of any extension help, farmers had no one to assist themselves when they faced problems during the cultivation and pest attacks. Dr Rao also observed that there does not seem to be much farmer education and follow up advice, which is supposed to be the responsibility of the seed distributor. Agricultural extension workers did not concern themselves about Bt cultivation, as this was considered a private sector affair. He is of the opinion that the scientific community and department of agriculture are equally to blame for the way in which transgenic technology is being introduced, without much public awareness and farmer education programmes No regulatory structures set up Gene Campaign found that neither state level nor district level committees had been set up in either Maharashtra or Andhra Pradesh where Bt cotton was being commercially grown. This is a breach of law and a direct violation of the prescribed rules for the manufacture, use, import, export and storage of hazardous micro-organisms and genetically engineered organisms and cells, under the Environment Protection Act, 1989, says the study. Enquiries made during their (Gene Campaign) survey also revealed that no one had come to that area to collect field data for monitoring the insect attacks and crop performance so at least in this area, no baseline data are being collected to evaluate the impact of Bt cotton on the environment, on beneficial insects, on other cotton crops and on the ecosystem. This amounted to gross negligence. Poor quality of Bt cotton variety Gene Campaign report says that Mahyco-Monsanto's cotton varieties, MECH 162 and MECH 184, which were transformed to Bt 162 and Bt 184, are poor to modest performers, giving modest yields. A better performing cotton would give a better Bt cotton so the GEAC must answer why it approved this Bt cotton when better quality Bt cotton hybrids belonging to Indian companies are in the pipeline. Dr Rao also remarked in his report that it is unfortunate that Bt gene was not put in the best Indian variety of cotton. Refuge crops Bt cotton must be grown with a refuge, necessary for resistance management. This is recommended as 20 percent of the cultivated area by the GEAC. "Wasting" 20 percent land on managing resistance makes the Bt cotton even more nonviable, especially for small farmers, stated the Gene Campaign report. On interacting with the farmers, Dr Rao also found that they are not happy using non-Bt cotton (of the same variety) as the refuge. They would prefer a non-cotton refuge. Susceptibility to pink bollworms The Gene Campaign study showed the vulnerability of Bt cotton to pink bollworm, which is a significant cotton pest in India. The report says that the Bt strategy for cotton is likely to fail because if the Bt endotoxin protects only against the green bollworm and not against the pink bollworm, then farmers will have to continue pesticide sprays. According to the report another factor, which needs to be investigated with some rigor is the period of gene expression of the Bt gene in each of the varieties in which it is being incorporated. If the period of endotoxin expression does not coincide with the period of pest attack, then no protection will be available against the bollworm, adds the study. ]]> <![CDATA[Moving research to market]]> https://biospectrumindia.com/news/95/2139/moving-research-to-market.html https://biospectrumindia.com/news/95/2139/moving-research-to-market.html Mon, 20 Oct 2003 16:48:00 +0530 NATIONAL CHEMICAL LABORATORY With the changing scenario in science, technology, and industry, this premier organization is changing constantly to be current and contemporary. Pune-based National Chemical Laxboratory (NCL), a constituent laboratory of the Council of Scientific and Industrial Research (CSIR), started five decades ago with the purpose to advance knowledge and to apply chemical sciences for the good of people, is a vibrant organization. It is striving to deliver outstanding performances in each sphere of its activities and live up to the mission that it was entrusted with. It has one of the best track records in the nation through its contributions to the corpus of human knowledge in the area of chemistry and allied disciplines. It has been committed to the development of processes, materials, and products. It is second to none in terms of maintenance of national resource centers of expertise, facilities, information and knowledge. It has created and trained a cadre of highly skilled scientific workers. Its influencing role in national and international scientific associations, governmental bodies etc., is very lofty. For all this and more, it falls in the category of "high output, high impact" institutions in the country along with IISc, TIFR, AIIMS, IIT-B, IIT-K, IACS and Hyderabad University. The laboratory over the years has forged strong industrial and academic collaborations in pursuit of its objectives. It works closely with many international companies and over 50 Indian companies. Some of the largest companies, within and outside India, have benefited by such collaborations. Examples include Reliance Industries, Indian Oil Corp., Oil and Natural Gas Commission, and pharma majors like Ranbaxy, Cipla, and Cadila, and global companies like GE, Dupont, Dow Chemicals and Unilever. It has close academic links with several universities both Indian and foreign as well as with several multilateral international R&D organizations. Besides biotechnology, the core R&D areas of NCL include catalysis, organic chemistry, polymer science and engineering, advanced molecular materials, chemical and process engineering, scientific computing, theory and molecular modeling. Strong biochemical science and engineering backed by inputs from other diverse disciplines provided an extra dimension to NCL's biotechnology program. Multidisciplinary biotech group The biotechnology group at the laboratory is a multidisciplinary and multi-skill R&D group with interest in the area of biochemistry, molecular biology, microbiology, botany, and biochemical engineering. It is supported by the state-of-the-art experimental facilities, large-scale pilot plants for plant tissue culture, and scaled up facilities for microbial processes and downstream separation. The laboratory's strong knowledge base has established its competency in taking up projects in the areas like plant molecular biology and agricultural biotechnology, plant tissue culture and microbiology, and enzyme technology. In addition to taking up the projects, its process development and design activity provides the vital link for translating a laboratory process to a commercial plant. A team of chemists, technologists, and engineers work together in achieving this task. The team members have acquired considerable experience by implementing a number of projects of NCL and also participating with industrial organizations and engineering companies on other projects. The process technologies developed and implemented encompass a variety of areas like catalytic and non-catalytic processes involving esterification, hydro-genation, oxidation, acylation, chlorination, fermentation as well as polymerisation. The process design and development groups has state-of-the-art of pilot plants for scale ups as well as design tools for preparing basic and detailed engineering packages, equipment specifications and mechanical design. Patents available for licensing Title Patent No. Date of Grant Cultural medium for bamboo shoot sprouting and multiplication and a method for sprouting and multiplication of bamboo plantlets US 5750401 12 May 98 Strain of cephalosporium having ATCC accession no. 74297, A process of isolating said strain of cephalosporium and a process for preparing extra-cellular endoxylanase US 5534429 9 July 96 Process for producing alcohol US 5455163 3 Oct. 95 A strong team of scientists at NCL, having vast experience in academic as well as industry, is working on several biotechnology-related projects. The projects are from as diverse fields as agriculture, environment, and industry. The scientists, in agri division, are working on transgenic crop plants, micropropagation, production of phytochemicals, biotechnological investigations for improvement of mango and medicinal plants. They are involved in the development of eco-friendly bioprocesses like use of enzymes as alternatives to hazardous chemicals in leather processing, cellulase-free xylanases in biobleaching of wood pulp, biosorption of heavy metals and biocontrol of injection in plants. Although the focus is on taking up pilot projects, the NCL is doing to good work by having tie-ups with universities and companies.   Market-oriented research To meet the requirements of the society and industry in particular, NCL is offering services in the form of technology licensing, doing contract research, working on collaborative projects, doing consultative and technical services, and information-based products and services by developing state-of-the-art technologies for clients in India and abroad. With a mission to "Linking NCL Research to Market Needs" the laboratory has a Research Planning and Business Development (RPBD) Group that handles all administrative matters relating to agreements between NCL and a client. Even though, it is part of CSIR, it has faced financial hurdles. In early Nineties, it had taken loans from private financial institutions and the World Bank to pay for reimbursement of research facilities. This drove NCL to look at contract research with multinationals as a business opportunity. These lessons helped the laboratory to negotiate with the companies, which have immense legal clout far superior to what a lab like NCL possesses, to generate more than 18 percent of its total budget. Over the years, it has improved its credibility and aggressively pursued the patents as a goal and this has helped the organization in earning the respect among customers. NCL has learnt to negotiate and license IPR's to the companies outside India. NCL plans to look at such technologies, which are highly proprietary and are difficult to source. This, it wants to create an inventory of such technologies and explore its relevance to India. Besides NCL looks at materials whose transportation costs are higher. Indian manufacturers of such products are effectively insulated from the threat of competition by imports. At the dawn of new century, NCL looks to the future with renewed optimism. Its vision is to ensure the supremacy of the laboratory in emerging areas of chemical and biotechnology related fields and to perform research, which is intellectually challenging and globally competitive. To fulfil its mission to use chemical and related sciences to produce useful materials and substances efficiently thereby creating value to the customers in particular and society in general, NCL believes that its research must be related to the real world and go beyond mere intellectual stimulation. Narayan Kulkarni Biotechnology research activity The division of biochemical sciences comprises of 30 scientists and 20 Ph.D students. Scientists are specialized in biochemistry, microbiology and molecular biology. Besides the inhouse funding, the research is also supported through external grants from Government funding agencies such as DST and DBT, New Delhi; industries and international organizations. Besides carrying out high quality basic research, major emphasis has been to exploit the research findings for developing, products and processes of commercial importance. The three main areas where the ongoing research finds potential applications include environment, agriculture and health related issues. MICROBIAL TECHNOLOGY Development of eco-friendly technologies using enzymes Leather industry: NCL, in collaboration with CLRI, Chennai, has developed a fungal alkaline protease which has shown promising results when evaluated for soaking, dehairing and bating in commercial tanneries. NCL is one of the participating institutes in a New Millennium Indian Technological Leadership Initiative Coordinated Program devoted to the development of cleaner biotechnological leather processing. Textile industry: Application of cellulases in textile industries for denim washing is relatively a recent area of research interest. NCL has identified an alkalothermophilic actinomycete culture producing an alkali stable cellulose. Evaluation of this cellulose in textile industry conducted in collaboration with Ahmedabad Textile Industry Research Association (ATIRA) has demonstrated that the performance of the enzyme was comparable with the commercial enzymes but the enzyme was superior to them in the property of being able to function under non-buffering conditions which is a desirable feature for its commercial application. Paper and pulp industry: Use of cellulose-free xylanases for biobleaching of pulp is expected to prevent environmental pollution caused by the paper industry. NCL has identified several extremophilic microorganisms, which produce xylanases that are useful in enhancing the brightness of the pulp in par with chlorine bleaching exploiting the vast microbial biodiversity. Aspartic Protease Inhibitor for HIV NCL has isolated the first biologically derived molecule that inhibits HIV-1 protease, the enzyme involved in the multiplication of the AIDS-causing virus (HIV). The NCL team has demonstrated that an Aspartic Protease Inhibitor (ATBI) is+olated from a bacterium the alkalothermophilic Bacillus sp. That thrives in adverse environments shows inhibition against recombinant HIV-1 protease. NCL inhibitor has an amino acid sequence that shows no similarity to existing inhibitors and represents an exciting new class of inhibitors with important implications for AID therapy. The US and Indian patents have been granted for the process of preparation of aspartic protease inhibitor. Cysteine protease Inhibitors against malaria Malaria is one of the most prevalent infectious diseases of mankind. Its control is becoming increasingly difficult due to the increasing incidence of strains resistant to currently used drugs. A program on screening of microbes for isolation of antimalarial compounds sponsored by a pharmaceutical company has resulted in the isolation of a few potent cysteine protease inhibitors which exhibit a significant growth inhibitory activity against Plasmodium falciparum in a biological assay based on the inhibition of trophozoite formation.   ]]> <![CDATA[News Analysis]]> https://biospectrumindia.com/news/95/1686/news-analysis.html https://biospectrumindia.com/news/95/1686/news-analysis.html Mon, 20 Oct 2003 14:00:00 +0530 A bio lab on a chip A bio lab on a chip Micro-arrays and integrated electronics and photonics on a sliver of silicon let researchers probe for individual genes responsible for a disease The semiconductor technology company STMicroelectronics has produced a silicon chip with micro arrays that support on-chip DNA analysis at the genetic level. When DNA from diseased and healthy sources is added to the silicon, it becomes a platform for genetic research into the cause of diseases. The monolithic (one-chip) array includes the sensing and supporting electronics. A media group taken to Catania, Sicily in South Italy in September was shown a machine placing droplets containing DNA onto silicon; through a scanner, computer and software. We then saw the array of color dots representing healthy gene pairs and those that were likely candidates for specific diseases. The array of tiny dots on a silicon surface allow genetic researchers to accurately place a single polynucleotide strand of the twin-strand, double-helix DNA from individuals with specific diseases (the target DNA) along with a strand of healthy DNA as reference (the probe). The objective is to find out the precise difference between the two DNA strands, thus identifying the genes that could be responsible for the disease. Like a lock and key, the two strands will come together completely if the specific deoxyribose and phosphate groups are complementary, forming strong covalent (chemical) bonds. If there is a difference, that pair will not form the bond, showing a different color characteristic. One end of the DNA strand itself forms a covalent bond with the silicon, anchoring it firmly in place. The chromatically marked DNA fluoresces when excited by electrons and this can be detected by photo-sensors. Different colors indicate whether the gene pairs have paired correctly or not, and therefore whether they are identical or different. Such a micro-array silicon platform for DNA allows the monitoring of expressions of 10,000 or more genes at a time. And the single piece of silicon contains the active electronics, and even the micro-channels carrying the DNA fluid, all integrated into one piece of silicon, increasing the speed of analysis and reducing its cost. The solution with the DNA can even be transported by capillary forces in the micro-channels. The silicon chip integrates even the photo-sensors. This is an achievement, as silicon's optical properties are not suited to either photoreceptor or light source use, which is why devices like LEDs tend to use gallium arsenide and other "III-V" compounds, so called because they belong to groups III and V of the periodic table of elements. But this would mean that adding an LED or photoreceptor to a silicon device would involve multiple stages and devices. To integrate the whole device out of a single piece of silicon, STMicroelectronics engineers "doped" the silicon with specific "impurities" to change its optical properties, in this case to create a photoreceptor element on a silicon chip, which can detect the fluorescence and color of the DNA just above it. Thus, adding optical functions to silicon helps allow active DNA analysis within a silicon chip, and the integrated electronics in the same silicon senses and communicates the color changes in the DNA pairs in the array. Using silicon for the base substrate for the DNA analysis also has other advantagesâ€”mainly, a great benefit in signal to noise ratio. Glass itself would fluoresce, so such background noise from glass would have to be "subtracted" from the results of such an experiment. Parallel with the silicon biosensor array development is ongoing research into DNA strands to explore genetic pairs as alternative memories, including research on organisms that change state or color after absorbing a photon, making them candidates for future "optical storage". While yet at the research and testing stage, ST officials say they expect to manufacture the "gene platform" biosensors in a year for "simple stuff" and in three years for "more complex stuff". The $6.3 billion STMicroelectronics is the fourth-largest semiconductor company in the world. It is particularly strong in "system-on-chip" technology. The ST group was formed in 1987 after the merger of SGS of Italy with Thomson of France. In May 1998, the company changed its name from SGS-Thomson Microelectronics to STMicroelectronics. Today, it has 43,000 employees (including over 1,000 in its India development center in Noida, UP), 16 R&D units and 39 design and application centers. The company is NYSE-listed ("STM") since 1995. Prasanto K Roy traveled to Catania, Sicily in South Italy at the hospitality of STMicroelectronics AP leaves no stone unturned The state is moving at a rapid pace to promote biotechnology in the state. With every state concentrating on promoting biotech, the big question that arises is which is the biotech capital of India? Is there a clear trend? Our recent survey points out that the South has the largest representation of biotech companies. The companies from South accounted for 39 percent market share of the total biotech industry with revenue generation of Rs 899 crore. Out of this figure of Rs 899 crore, Karnataka accounts for close to Rs 500 crore, while AP for over Rs 200 crore. So is Karnataka the capital? "It is the Biocon group that comes in the way of Hyderabad being crowned the biotech capital of the country," remarked a senior official from the industry. How true! The biggest player in Karnataka is the Biocon Group with total revenues in excess of Rs 285 crore and accounts for greater than 55 percent of total contribution of companies in Karnataka. Statistics apart, is Andhra Pradesh really inching towards being the biocapital? Looking at the flurry of activity in the state, one cannot ignore it. It is leaving nothing to chance. Wooing the investors, building the infrastructure, spreading the awareness and increasing quality education. Chandrababu Naidu, the state chief minister, in the recently concluded Biotec International conference said, "For the phase-II of the Biotech Park, 162 acres of land has already been allotted. We have now decided to go for Phaseâ€”III and Phase-IV of the ICICI Knowledge Park, which is adjacent to Genome Valley. This will help to provide plug and play R&D facilities to biotech and pharma companies. A marine biotech park and Pharma city near Visakhapatnam will come up soon." A biotech incubator with assistance from DBT has been launched. Further an agribiotech park and incubator has been started on the ICRISAT campus jointly by the state government and ICRISAT. These are just some of the initiatives on the infrastructure front. On another front, the state is also forging several alliances globally. It signed a MoU with Thailand to mutually promote biotech through collaboration in research and exchange of scientists and teaching professionals. This MoU would pave the way for collaboration, particularly in marine biotechnology and biotech applications for aquaculture and tropical medicine. With Iowa State of USA, it would collaborate on research and business in agribiotech and bio-medical research. With Saskatchewan of Canada, it will jointly promote technology transfer, research collaboration, regulatory approvals, educational exchanges etc. While these are some of the latest developments, the State had entered into an agreement for collaboration with Research Triangle Park of North Carolina last February. These are now producing results. CiVentiChem, an US-based contract research and drug discovery support company announced the formation of a subsidiary, Indus BioSciences, in Hyderabad. Similarly, Kard Scientific Inc. of Cambridge, USA is setting up its unit for drug development in SP Biotech Park. Several other pharma and biotech companies, such as Astra Zeneca, Pfizer and Chemical Diversity, Genoexpression, Transzyme have agreed to start their Biochemical R&D operations and contract research in ICICI Knowledge Park and SP Biotech park. The deals are expected to be finalized. Indian firms like Ranbaxy too have announced to set shop. What separates it from the rest? The state has a large number of pioneers, the biotech initiative started as early as 1997 with the setting up of an advisory committee, a chief minister who is a favorite of the scientific community, great institutes like IICT, CCMB, National Institute for Nutrition, and the Centre for DNA Finger Printing and Diagnostics â€¦ The list can continue. But the differentiation is AP has set itself an ambitious vision. Naidu's vision statement explains, "By 2020, the state will achieve a level of development that will provide its people varied and realizable opportunities to achieve prosperity. We, therefore, propose to give a thrust to knowledge-based industries such as IT, biotechnology and pharmaceuticals. Biotech is a frontier technology, which has the potential to provide substantial benefits to the society in a wide range of sectors, such as agriculture, medical and health, forestry, and animal husbandry." This intention is the biggest facilitator. The state has a biotechnology policy, APIDC Venture Capital Ltd, a joint venture between the AP Industrial Development Corporation and Dynam Venture East of USA, which has been providing venture capital to biotech start-ups. It has also an integrated IPR facilitating cell at ICICI Knowledge Park established is association with CII. This is to cater to the growing demands of the industries in AP for patent search and analysis, patentability advisory services, IPR awareness and training. With the basics in the right place, so what should be the next step? Dr D Balasubramanian, director of research, LV Prasad Eye Institute, Hyderabad, who is also the advisor to the state government, has a few suggestions. "AP should discover, manufacture, and distribute vaccines. It should be the global vaccines supplier. It should attract a few world leaders in the biotech sector to set up operations in the parks. Put up an animal research and testing in the park. The International Institute of Life Sciences should be set up soon." With such visionaries around, entrepreneurs taking the risk, and a supportive facilitator, it is only natural for Andhra Pradesh to be "a neighbor's envy, owner's pride". Ch. Srinivas Rao Gujarat evinces interest in biotech The biotechnology policy is yet to be declared, but the state steps up the tempo. It was like any other conference of the industry and public were interested in knowing what is happening in biotechnology. The auditorium was packed. Everyone at the auditorium was eager to listen to the words of the speakers like Ajay Piramal, Habil Khorakiwala, Dr Rashmi Barbhaiya, Utkarsh Palnitkar, M Vidhyasagar, Dr Sudhir Paresh, Dr Harish Padh, Dr Urmish Chudgar, Alok Gupta, Prof. BB Chattoo, who are attached to biotechnology sector in one or the other way. The speakers made presentations on varied topics from global trends shaping the health sciences industry to biotechnology and pharmaceutical sciences to the dawn of a new era on the Indian horizon. The conference was on "Pharma Biotechnology Development in Gujarat". You may ask what was so special about this conference and why are we referring it? It was a first conference on pharma biotechnology in Gujarat. And more over it was a part of the three-day "Vibrant Gujarat - Global Investors' Summit"organized by the government of Gujarat. Looking at the presence of the audience and speakers, it was difficult to say the conference was a global one. This being the first conference in pharma biotechnology, it was able to get the attention of the industrialists and also the attention of the investors, who announced an investment of about Rs 350 crore in different projectsâ€”from setting up of BT park, green house technology plant, International Pharma and Biotechnology Park to plasma fractionation centerâ€”in the state. Expressing satisfaction in organizing the conference, Rajesh Kishore, secretary, department of science and technology, government of Gujarat, who was instrumental in organizing this conference said, " The critical thing is not in organizing the event but to keep the momentum going. That will take lot more efforts. We will put in that kind of efforts and organize four more events in different sectors of biotechnology such as agribio-technology, industrial biotechnology, marine biotechnology and bioinformatics before the end of this fiscal." Replying to the queries on the participation of investors at the meet, Kishore said, "I didn't believe in numbers. The key objective of this event is to provide a platform to discuss a lot about the happenings in the industry. This will give a little bit push. Champions are here. They want some support to venture into this new knowledge-based industry." He even said that things were being carefully planned for the sector and success should not be judged by the announcements made at the summit. Industry's concern The industry still has its concern on the issue. The industry captains, who made their presence felt at the conference, said that they can't go with the speculations and hype. They want some concrete measures from the government in the form of policy on biotechnology. The state government is already working on it and is also in the process of setting up a biotechnology mission to draw up strategies. BioSpectrum brought this to the notice of the chief minister of Gujarat, Narendra Modi, who made a brief visit to the NID complex, the venue of the conference, who had earlier in February this year assured the industrialists of providing all the necessary support at Biotech India 2003 event. Commenting on the delay in announcing the Biotechnology policy, Modi informed us, "No government will run without a policy. Biotechnology policy is there but not yet declared." The government signed a MoU with Ganesh Housing Corporation Ltd, which is setting up International Pharma & Biotechnology Park at Ahmedabad. This measure shows that the government has kept up its assurances of providing the necessary facilities to the industrialists, who are looking at Gujarat for their biotechnology ventures. Though Gujarat's pharmaceutical sector accounts for around 45 per cent of the total pharmaceutical output of the country with players like Zydus Cadila, Alembic, Sun Pharmaceuticals, Torrent Pharmaceuticals, Cadila Pharmaceuticals, Ambalal Sarabhai Enterprises and Intas Pharmaceuticals to name a few, the local pharma industry was not upfront at the conference. Pankaj Patel of Cadila Healthcare and Dr Urmish Chudgar of Intas Pharmaceuticals made presentations. But the enthusiasm among the scientific community, students, public and government officials about the upcoming biotechnology industry will definitely help biotechnology to take shape in the state. The participation of chief minister Narendra Modi and his ministerial colleagues at the conference shows the state's interest in developing biotechnology. Besides pharma, the state has already identified healthcare, agricultural biotechnology, industrial enzymes, bioinformatics, contract research and marine and environmental biotechnology as thrust areas and is planning to organize events in agri and industrial biotechnology next month. A beginning has been made. The thing is to keep the momentum in place. Narayan Kulkarni               ]]> <![CDATA[Aiming high]]> https://biospectrumindia.com/news/95/1104/aiming-high.html https://biospectrumindia.com/news/95/1104/aiming-high.html Mon, 20 Oct 2003 13:50:00 +0530 Biotechnology in India is no longer confined to research laboratories and is now alive and kicking as a Rs 1,830 crore industry, remarked a write-up in the venerable The Hindu about the BioSpectrum-ABLE industry survey. That sums up the current status and the rosy future that lies ahead of the biotechnology industry. This optimism has been reinforced by the country's topmost biotech policy maker, Dr Manju Sharma. While responding to BioSpectrum's July cover story on "The Top 10 Hurdles Facing the Biotech Industry", the secretary of the Department of Biotechnology (DBT) has struck an optimistic note. She was confident that most of the hurdles would not remain as roadblocks for long and the industry could look forward to a bright future in five years. Dr Sharma has been guiding the growth of this industry for nearly a decade. She has rightly pointed out the major initiatives and support provided by the government to accelerate the growth of biotech. The DBT chief has been repeatedly stressing the importance of equal levels of commitment and risk-taking by biotech entrepreneurs too. Three other major developments which have taken place in different states reinforce the faith in the prospects of the industry. In August, the Kerala government has announced a forward-looking biotechnology policy to leverage the state's strengths in the phytopharmaceuticals and related areas. Kerala has also roped in a biotech hotshop Avesthagen as a partner to develop this sector quickly. In September, another southern state, Andhra Pradesh, reasserted its primacy in the biotech arena by showcasing its strengths at a major four-day event in Hyderabad. The country's first biotechnology fund, floated by the state government has also taken off with a bang, announcing three major investments. To consolidate the gains, the state plans to entice biotech investors from all over Asia by organizing another big event in Hyderabad next February. The third heartening development is the choice of biotechnology as one of the major segment to attract investors by the western state of Gujarat. The country's second most industrialized state after Maharashtra is keen to ensure that it does not miss the biotech bus. It doesn't want to repeat its mistake in ignoring the booming information technology sector. There are indications that Chief Minister Narendra Modi will pull out all stops to tap the entrepreneurial spirit of Gujaratis all over the world in biotechnology. It is clear from these different initiatives that promotion of biotechnology need not any longer be the burden of the Central government which has carried this since 1986 at least. Dr Manju Sharma can breathe easy. With more enthusiasts in states, biotechnology could benefit from the increased attention it will get from the nation's political and bureaucratic leadership. Yet another indication is the Maharashtra government's decision to celebrate former Prime Minister Jawaharlal Nehru's birth anniversary on November 14 as the "Biotechnology Day". The event had started last year but the scale and scope will increase this year, perhaps in keeping with the increasing importance of biotechnology. We couldn't have asked for more. ]]> <![CDATA[Global Census: Top 12 biotechnology countries]]> https://biospectrumindia.com/news/95/7480/global-census-top-12-biotechnology-countries.html https://biospectrumindia.com/news/95/7480/global-census-top-12-biotechnology-countries.html Mon, 20 Oct 2003 13:46:00 +0530 No. of biotechnology companies (public companies) Source: Ernst & Young ]]> <![CDATA[Test and patent traditional products for all diseases]]> https://biospectrumindia.com/news/95/1460/test-and-patent-traditional-products-for-all-diseases.html https://biospectrumindia.com/news/95/1460/test-and-patent-traditional-products-for-all-diseases.html Mon, 20 Oct 2003 13:39:00 +0530 The community of Indian research workers, contributing to this important task of integrating the ancient with the modern, need to always look for protection of any intellectual property which meets the basic requirements of novelty, usefulness and non obviousness. Can the existing knowledge and products based on them be protected? The answer is "no". What preexists, what is in the public domain cannot be protected. Natural products cannot be protected. Further, the preparations that have been used for many years constitute knowledge in public domain. Therefore, they cannot be patented. However, if new uses are found, a "use" patent can be obtained. If this is the case, what can we protect? If a non-obvious technique has been employed for fractionation of constituents of herbal formulations, then an international patent becomes possible. Similarly, if synergism is shown between two fractions, which is very likely in Ayurvedic preparations, patenting at international level is permitted. All the preparations arising out of Ayurveda should be tested for as many diseases as possible. Any preparation found effective in diseases, which has not been already described in literature, can be patented for that particular disease. Science-based products Ayurvedic products can have four different types of uses. First, for minor ailments like dyspepsia, unpleasant taste, anorexia, and biliousness. The second major set of uses is likely to include detoxifiers, rejuvenators, toners, resistance builders and for longevity. Both these sets of preparations are likely to be available over the counter (OTC). The third use will be support therapy, where these therapeutics may be given along with the allopathic preparations. These will most probably be prescribed by the medical practitioners who use combo-therapy to take advantage of the synergy between the two sets of preparations, for the overall benefit of the patient. In combo-therapy, bioenhancers, detoxifiers, toners and specific therapeutic agents are used which accelerate recovery. Hospitals may also make similar use based on the existing system. With time this combo-therapy concept may be accepted in India too. The fourth use of the traditional medicines is likely to be the treatment of old age diseases for which these systems have already shown a great degree of efficacy. The old age diseases which will be of increasing concern to the West include various forms of cancer, AIDS, osteoporosis, arthritis and related diseases, Alzheimer and Parkinson's diseases (to some extent) and obesity. These diseases are likely to be treated in three ways in future viz., through completely allopathic treatment, through completely traditional methods in special traditional systems based hospitals where both the philosophy and treatment will be traditional and the third and most likely method will be a combination of both. In this quick reduction of disease intensity will be brought about through allopathic system but the long-term treatment, convalesce and resistance building will be achieved by using techniques of the traditional systems of medicine. To create new Ayurvedic products, knowledge based on modern biology and chemistry needs to be integrated. This will result in better definition of the existing products, improved understanding of their mechanism of action, modified composition at molecular level and better understanding of interactions amongst various molecules. Potential knowledge-based new products Traditional preparations based on plant extracts can end up containing hundreds of molecules. Many of them are fillers, whereas some may be even toxic. The remaining may be beneficial. It has been shown quite often that there can be considerable degree of synergy among various molecules of a plant extract. Thus, in such a case, the whole fraction or its sub-fraction will be an appropriate preparation, particularly if some of the other fractions turn out to be relatively toxic. The advantage of a trim product containing limited number (say around 10) of molecules is that it can be molecularly defined (rather than the HPLC defined products used at present). Further, the interaction of these molecules with other drugs can be investigated and documented much more easily. As the concentration of the active molecules is likely to be high, such products will be fortified in nature. If the mechanism of action of such products can be explained at molecular level, the product will automatically have higher credibility. There are products of Ayurveda, which by themselves are not efficacious against a particular condition but enhance the efficacy of another drug. Such components are routinely found by one of the CSIR laboratories and these contain components, which may increase the bioavailability of an allopathic drug or act as a catalyst for some other biological activity. The new area of research is a clear result of trying to understand Ayurvedic practices through the techniques of modern biology. If any such bioehnancers can be discovered from the practices of traditional systems of medicine of the whole world, for highly toxic drugs used for diseases like various kinds of cancer and AIDS they will bring down the dosages and thereby the toxicity of the current drugs. New bioenhancers may be discovered based on the possible mechanisms through which these agents may be acting. Though detoxification is practiced in other traditional systems of medicine also, Ayurveda has much more elaborate procedures of detoxification. For most purposes, however, the mild detoxification procedures through the digestive tract and the skin are practiced. These can be practiced even without a prescription, for maintenance of good health. If molecularly defined detoxifiers can be generated along with their mechanisms of action, this mild therapy can become extremely popular with the health conscious people of all regions. With the use of products which are molecularly-defined and mechanistically understood, there is great potential of using fractions from plant extracts not used for therapeutic purposes at present. Such new herbal preparations can significantly increase the number of therapeutic preparations of herbal origin available for the health-care of the world. A new concept of Ayurvedic practicesâ€”from the practice in Ayurveda of adding trikatu (a mixture of black pepper, long pepper and ginger) to many formulations has resulted in notion of a "bio-enhancer", which improves the bio-availability and bio-efficacy of a drug without itself acting as a drug. Piperine has already been shown to be a bio-enhancer for refampicin during the treatment of tuberculosis. The concept developed by Regional Research Laboratory, Jammu, based on ayurvedic practices can be easily assimilated by not only allopathic system but also by other traditional systems of medicine. Search for bioenhancers working in different ways from ayurvedic preparations needs international attention, research effort and eventual use. How do we get scientists interested in such research? The first need is to expose good scientists to the accumulated wisdom of the ISM. There is no doubt that enormous opportunities of doing focused basic-cum-applied research exist in this area. For example, the mechanisms of action of Bhasmas, detoxification mechanisms involved in reversal of aging, bioenhancers, and molecular synergism offer a large number of scientifically challenging and commercially useful issues to work on. Initial interactions between scientists and practitioners of ISM may be difficult because of different operational nomenclatures, but with time communication becomes excellent. For holding discussions and having interactions with ISM practitioners, there is a need for group meetings but also more importantly, there is a need for "meeting of minds". What is urgently required is the change in attitude of scientists, traditional practitioners and industry on one hand and the special policy initiatives by the Government on the other. Then only we can create the golden triangle of traditional machine, modern machine and modern science. RA Mashelkar ]]> <![CDATA[Bioentrepreneurship: The road less traveled]]> https://biospectrumindia.com/news/95/2907/bioentrepreneurship-the-road-less-traveled.html https://biospectrumindia.com/news/95/2907/bioentrepreneurship-the-road-less-traveled.html Mon, 20 Oct 2003 13:31:00 +0530 Dream. And everything in this universe will conspire to make it happen. This profound line from Paulo Coelho's The Alchemist is of great relevance to a bioentrepreneur. This decade, which is all set to see a biotechnology boom will belong to those who have the power to convert their dreams into reality. In other words, it will see the rise of the bioentrepreneur. The ones who will move away from the safe waters of the laboratory and convert a patentable/testable research dream into a viable business proposition. The success mantra: willingness to change perspectives when faced with new ideas or situations and the ability to adapt. Bioentrepreneurship in India The concept of bioentrepreneurship is still new in India. Scientists in our country follow the road lined with obvious well-defined rules and symbols. While the need for academic excellence is understandable, the world out there is waiting for safe, affordable, healthcare solutions that can affect millions of lives. It is biotechnology that can come up with answers. Every would-be entrepreneur, scientist or a professor in India must understand the need to find a market for his research dream. While continuing the basic research, he must develop products/solutions that could immediately translate into use for the consumer.xxxx The efforts of global biotechnology community are setting an example. Much of the efforts today are focused on treating, detecting and preventing human disease. Top research areas include cancer, AIDS, neurological disorders, heart disease and diabetes among others. With newfound information such as mapping of several genomes, novel therapeutic and diagnostic breakthroughs are emerging. Every bioentrepreneur must thoroughly understand the grassroots of biotechnology sector such as research, collaboration, infrastructure, technology and commercialization capital and come up with an alternative business model to achieve success. Alternative business model Curiosity is often what attracts a potential bioentrepreneur to the laboratory in the first place and may be the key motivator behind his or her foray into business. It is curiosity that keeps work productive and refreshing but bioentrepreneurs need to back up that curiosity with creativity. Entrepreneurs complain that even when they are prepared to make the break with established conventions, they cannot find the necessary business talent to help them turn ideas and intellectual property into a growing concern. Unlike in the US, where people who are on their second or third company already and who have gained the business experience they need to deal with venture capitalists and potential customers, the biotechnology industry in India is still too young to have those kinds of resources to draw on. Model for success Understand the basic technology you propose to adapt Align with a partner to enhance core potential Take regulatory framework into consideration Enter into proper legal documentation before commencing the work Be prepared to adapt changed strategy while during the development process In this scenario, would-be entrepreneurs must create their own business model to suit their bioventures. The clue is to work closely with Financial Institutions (FI)/Venture Capitalists (VC), the marketing team and the research team to develop a workable model. To ensure that perspectives are shared, one entrepreneur used a roundtable to ensure that everyone understood the game plan. It doesn't matter if those chosen are not involved in the company in the long run, but they provide valuable sounding boards and insights. For example, can a FI/VC grasp the technical concept in the first place and will a marketing expert see what makes the product unique? Working with others in different fields will answer difficult questions and provide insights into new ones. Once the basic planning is done, the second most important thing to do is to devise a phased plan for investment. The first three years for a start-up biotech company are the most difficult years. Entrepreneurs are forced to invest in appropriate technologies to get the project off the ground. It is in this phase that money-management becomes crucial. It is also in this stage that a budding entrepreneur must be willing to change perspectives. He must creatively chalk out a novel approach that would help maximize the returns on his investment. Collaborate Collaboration and effective sharing of knowledge are key attributes of the biotechnology industry. Every bioentrepreneur must understand this attribute and use it wisely. With specific reference to India, would-be entrepreneurs can take advantage of the vast knowledge pool created by scientific institutions. Demonstrate the principle/patent of the academic institute and create an active liaison for sharing of expertise. Or take academic work to pre-clinical and clinical trials to check the efficacy of the said principle. While collaborations take on many different forms that range from the traditional multi-party efforts, to virtual networks of computer technologies linked together, to universities establishing joint venture research facilities, to university-industry partnerships, choose the one that suits your bioventure. Despite vast improvement in technology and communications that allow truly global collaborations to take place, the more traditional platform based on physical proximity remains the key component of the development of biotechnological activity. Bharat Biotech for instance, works with collaborators such as Centers for Disease Control, Atlanta (USA), National Institute of Health, Washington DC (USA), All India Institute of Medical Sciences, New Delhi (India), Department of Science and Technology, GoI and a host of others in its quest for path-breaking technologies that ensure a disease-free future. Become a biomover Every bioentrepreneur, especially if he happens to be a scientist, must make a conscious effort to make the transition. Academic degrees and publications are valuable, but more intangible attributes win in businessâ€”adaptability, emotional intelligence, confidence, ambition, persistence, risk-taking, humility, flexibility and patience are some of the many attributes essential for coping in highly complex, ambiguous situations. Would-be entrepreneurs need to "turn the tables" and attend conferences that specifically address the elements of entrepreneurship as a "nonexpert"â€”often an unsettling experience. This would help assimilate what is expected from the scientist to satisfy marketing, business and other agencies. Though frightening at first, the process becomes more familiar and can be fine-tuned with experience. Confidence is a particularly important element of success. Bioentrepreneurs often reflect on how they coped with challenges in the past to build confidence in the future. In particular, they must be able to handle criticism and the many stressors involved in business life. Remember that bioentre-preneurship is not just about having good scientific/research ideas, but also about obtaining funding, developing a prototype and marketing the final product. This requires convincing others of your idea and involving them in your vision. One bioentrepreneur says, "Believing in the product and self is what counts ... finding others to share in those same beliefs is what success is." Build lasting relationships Building relationships is probably the most difficult task facing most scientists who aspire to be bioentrepreneurs. For many, the element of fear is associated with the factor of dealing with others from unfamiliar backgrounds. This can be overcome by accepting the need to change. There is considerable overlap and therefore common ground in the disciplines of science, business, and marketing; those setting out in this area would do well to recognise this, but this realisation requires a shift in perspectives. Successful bioentrepreneurs must develop good communication skills. They must write, speak clearly and confidently and they must be persuasive and creative. They must also develop excellent social skills. As a manager and leader of a medical biotech company, a bioentrepreneur may have to play many roles, becoming "cheerleader", "coach", "devil's advocate" and "lawyer" in order to create a cohesive team. The ability to build and foster relationships both inside and outside the company is essential. The road less taken And finally, vision. The road from concept to conquest can be tough and scattered with pitfalls. What may have been an accidental discovery may or may not become a marketable product. Many a time, it is the belief in the concept that can become the driving force behind its success. (Dr. Krishna M. Ella is the chairman and managing director of Bharat Biotech International Ltd (BBIL), one of the leading research-based firms in India. BBIL was established with the objective of providing affordable solutions to health problems in developing countries.) ]]> <![CDATA[Bt cotton fiasco: Turning a blind eye]]> https://biospectrumindia.com/news/95/1008/bt-cotton-fiasco-turning-a-blind-eye.html https://biospectrumindia.com/news/95/1008/bt-cotton-fiasco-turning-a-blind-eye.html Mon, 20 Oct 2003 13:17:00 +0530 Two years back, a British radio journalist had asked me "isn't it like sending a soldier to the battle front and then asking him not to use the latest sophisticated assault rifle"? He was referring to the Indian government's initial decision to burn down the illegally grown genetically modified cotton on some 10,000 acres of farmland in Gujarat. Since then, Bt cotton was allowed to be commercially grown in the southern and central states of the country. "It will certainly be tragic to deprive a soldier of the latest weapon. But it will be more sinister and criminal to provide the soldier with an AK-47 gun and then deliberately make him step onto a 'booby' trap," I had replied. Further adding that Bt cotton containing a gene from a soil-borne bacterium, Bacillus thuringiensis (Bt) is an attractive biological trap, more potent than the toxin it produces that kills the dreaded bollworm pest. "But then a majority of cotton growers are happy with the standing crop even if the seed was clandestinely supplied," asked the journalist, stating that there is a growing demand that the genetically modified crop, which has proved to be effective against the bollworm insects should not be destroyed. "Yes, you are very right," I replied. "This is exactly what had happened when the fourth generation pesticides, synthetic pyrethroids, were introduced in the country less than 20 years ago. And since then over 10,000 cotton growers have committed suicide." I had explained this elaborately in one of my columns. Friends of biotechnology industry however would not accept this. They went on harping about the significant economic returns that the farmer would get by cultivating Bt cotton. They talked of the benefit to the environment given the pesticide reduction figures that were very conveniently churned out. The Department of Biotechnology (as well as Mahyco-Monsanto) had claimed that despite the extravagant price of the modified seed, the net gain to farmers would be in the range of Rs 10,000 from an acre. Such was the desperation to push the risky technology that two researchers from the University of California at Berkeley and the University of Bonn in Germany were drawn in to justify the crop research trials that Mahyco-Monsanto had carried out. They did a remarkable job, painting such a rosy picture that embarrassed even the multinational giant Monsanto. Their paper published in the reputed journal Science in Feb 2003 extrapolated the flawed findings to all the crops, concluding that GM crops would increase crop yields in the developing countries by 80 percent! Bt cotton failure and that too in its very first year of planting has already been documented and much written about. So much so that even a Parliamentary Committee had put its stamp over the monumental scientific blunder. An official report prepared by the Andhra Pradesh government on the performance of Bt cotton in 2002â€”the first year of its commercialization showed that "in North Telengana region the net income from Bt varieties was five times less than the yield from local non-Bt varieties. In Southern Telengana, the income from Monsanto's Bt crop was nearly seven times less than what was obtained from the indigenous non-Bt cotton varieties demonstrating the resounding failure of the Monsanto variety." What does this report card indicate? Nothing. But surprisingly, no uncomfortable questions were asked, no heads have rolled and no one has been held accountable for the biggest scientific fraud to hit Indian science since independence. Neither the farmers have been compensated nor has the industry been blacklisted. Such is the lack of governance that the seed industry continues to multiply the sub-standard seed with impunity and is looking for a fortune from the torn pockets of the small and marginal farmers. Such is the callous apathy towards the farming community that the apex committee, Genetic Engineering Approval Committee (GEAC), has instead of persecuting the erring firms and officials, further allowed the seed companies to incorporate the Bt gene into any cotton variety. Let us try to understand the reasons behind the introduction of Bt cotton. The approval to Bt cotton stems from the fact that intensive cultivation practices and indiscriminate use of conventional as well as fourth generation pesticides like synthetic pyrethroids have created resistance among some of the key pests, including the American bollworm. Dependence on chemicals has in some cases been so heavy that farmers often resort to a mix of several pesticides, the so-called pesticides cocktail and it is not uncommon to spray more than 30 times per season. It is also true that if the crop fails because of weather conditions and/or pest resistance, a rising number of farmers have been known to consume the same chemicals to end their lives and escape the humiliation that comes with mounting debts. Simply for the sake of pest resistance, Bt cotton in any case was a faulty prescription. For it is widely accepted that in case of Bt cotton the third generation of the pest is the most problematic. But then you will ask how come the southern China farmers have been growing this variety and not encountering any problems? What is not known (or they don't want it to be known) is that Chinese farmers have to spray more pesticide to control third and fourth generation of American bollworm insects. At a recent international workshop at the Institute of Development Studies, University of Sussex (UK), I asked the representative of the Chinese Academy of Agricultural Sciences to explain as how should we believe the veracity of the official claims. He looked at me as if he had not even understood what I said. He was again quiet when asked as to what would the Chinese farmers do if the Bt crop failed. Would they demonstrate to show their anger? From the data presented, it becomes clear that the Chinese experiment too was nothing but sheer propaganda. In 1999, the first year of Bt cotton cultivation on a commercial scale, the pesticides usage had dropped to 7 kg. The next year in 2000-01, pesticides application had increased to 14 kg per hectare, a clear indication that the insect resistance had failed to sustain in the first two years. Asked about the results for 2002 and 2003 crop season, the answer is that such studies have yet to be undertaken. The reason is obvious. Pesticides applications have jumped up and the Chinese scientists and officials do not want to put their heads on the chopping block. Doesn't the rate at which pesticides applications have grown in the first two years indicate that pesticide usage has now multiplied to something around 28 kg per hectare (or even more)? If that be so, where is the gain? What has been the advantage of passing on this risky and expensive technology to farmers and at what cost? Isn't it a fact that the entire gain has been to the seed industry, which has walked away with huge profits leaving the farmers and the environment in deep crisis? Where is the Rs 10,000 per acre advantage that the Indian Department of Biotechnology had promised to cotton growers? In Australia too, farmers have now been advised to go in for more sprays because of a drop in expression levels. In India too, reports of breaking down of resistance against the bollworm pest have been widely reported. With the insect increasingly developing immunity against the Bt toxin in the plant, scientists are now trying to introduce genetically manipulated varieties with two Bt genes. It may then be the turn of a gene from scorpion, and then from a snake. The "biological circle of poison" is certainly going to be more dangerous than the chemical cycle that farmers have been forced to live with. It is a heavy price that the Indian farmers have paid and are more likely to pay in future with the introduction of Bt varieties. Devinder Sharma (Devinder Sharma is a New Delhi-based food and trade policy analyst. Among his recent works include two books: GATT to WTO: Seeds of Despair and In the Famine Trap.) ]]> <![CDATA[Indian biotechnology needs truth, not hype]]> https://biospectrumindia.com/news/95/2900/indian-biotechnology-needs-truth-not-hype.html https://biospectrumindia.com/news/95/2900/indian-biotechnology-needs-truth-not-hype.html Mon, 20 Oct 2003 13:13:00 +0530 Truth is the most powerful weapon in the world. This becomes particularly important in the emerging areas of technology such as biotechnology. Today informed public opinion around the world has become extremely wary of unethical and false claims about products that are marketed by high-pressure advertising and endorsements from familiar faces. As they have little or no technical knowledge of parameters that would define the quality of the product they are endorsing, leave aside the extent to which the quality criteria are really satisfied by the product. People around the world and now even in our own country are becoming increasingly aware of the technological complexities of the new products (be they seeds or cars). It is a clichÃ© that for new technology products to succeed, the confidence of people in the technology must be high. Therefore, for the success of biotech products, we need to present the truth, the whole truth and nothing but the truth about them to the people. Only recourse to this time-tested prescription will lead to public acceptance of biotechnology. Not only that, the larger number of mistakes we make in this regard now, the greater would be the effort required for acceptance of the truth later by the public. Once bitten, twice shy! Today in UK as perhaps in the rest of Europe, four out of five people are totally opposed to GM food (food prepared from genetically manipulated organisms). This is the consequence of the greed of multinationals and their desire to control people around the world, which has led to an uncalled for and unproven hype about GMOs (Genetically Manipulated Organisms) released in the environment and suppression of vital information about them. For biotechnology to succeed, this greed must be replaced by true commitment to public good and truth. Let me give a specific example of the so-called golden rice. I was concerned at the hype surrounding the initial announcements about this GM rice. The public was given the impression that this rice will take care of the entire requirement of vitamin A of an individual. Such a statement would be extremely important for India where vitamin A deficiency affects a large proportion of people and is one of the four major nutritional health problems of the country. However, when we got down to the brass tacks and did our arithmetic, it was found that only a miniscule fraction of the daily requirement of vitamin A will be taken care of by the amount of rice one normally consumes in our country in one day. When I pointed out this to the inventor of golden rice at a meeting in Chennai on 30th October 2002 organized by National Academy of Agriculture, I was told that the daily requirement of vitamin A prescribed by WHO was unrealisticâ€“that is, far too high! Should WHO standards set up after stringent analysis cease to be a benchmark when they are inconvenient? Besides, for meeting even the prescribed WHO requirement of vitamin A, there are other cheaper and better sources already available. We have carrots available abundantly. A marine biotechnology company located at Tiruchendur is already producing beta-carotene using a marine alga and a low-cost production process that exploits sunshine and ambient temperature. Our problem with vitamin A deficiency is not the lack of sources of vitamin A but the lack of buying power. This is not to underrate the elegant work that led to the production of golden rice, but only to emphasize that the hype generated by the Department of Biotechnology (DBT) regarding golden rice has done a disservice to the cause. This is surely not where our country should invest in biotechnology. The same has been true of Bt cotton. To cite just one example, no protagonist of Bt cotton has spoken about the official governmental report (2002) of the Nanjing Institute of Environmental Sciences of the State Environmental Protection Administration of China on the impact of Bt cotton on non-target organisms and the development of resistance of cotton bollworm to Bt cotton there. On the other hand, the public has been always led to believe what a tremendous success Monsanto's Bt cotton has been in China. Let us now look at what is stated in the above report. The following quotes from the report (annotations that are not in quotes are mine) should give the reader a flavor of this report. "Domestically developed Bt cotton accounts for one third of Bt cotton seed market and this percentage should increase over the next few years." The percentage of acreage under Monsanto's Bt cotton has progressively declined from 1998 onwards. The question one may ask in the Indian context is-Why did we not make our own Bt cotton as China did, when one of the purposes of setting up the DBT in 1986 was to do precisely this kind of work? "The populations of parasitic natural enemies in Bt cotton fields are significantly reduced." "Bt cotton is not effective in controlling many secondary pests, especially sucking pests. Field experiments showed that the population of secondary pests, such as cotton aphids, cotton spider mites, thrips, lygus bugs, cotton white fly, cotton leaf hopper and beat armyworm increased in Bt cotton fields after the target pestâ€“bollworm had been controlled. Some pests replaced bollworm as primary pests and damaged cotton growth". Shouldn't we have had similar data for our country by now in respect of Bt cotton? "A higher insect dominance in Bt cotton than in the non-Bt control suggests an increased potential for pest outbreaks for certain pest species in Bt cotton fields". "Both laboratory tests and field monitoring have verified that cotton bollworm can develop resistance to Bt cotton". "The resistance of Bt cotton to bollworm decreases over time, and control is not complete in the third and the fourth generations. In fact, farmers must use chemicals two to three times to control bollworm". "There are not yet effective measures to postpone resistance development or to resolve the resistance problem. A high-dose of the Bt toxin protein is considered difficult to obtain, and the refuge mechanism is not easily implemented. In addition, the high dose assumption and refuge design have theoretical shortcomings". In fact, Science (2003, vol. 299, p. 1013) has recently reported that in China, Bt cotton is not recommended for small farms. In our country, we have only small farms. If those who are advocating the use of Bt cotton in our country, including the DBT have any commitment to truth shouldn't they take the above into account when "selling" Bt cotton to ignorant and trusting farmers? The latest addition to the hype is the GM potato also sponsored and publicized by the DBT. First, it is no big deal to make a GMO todayâ€“even a GMO with a better or higher protein content as is claimed for DBT's GM potato. Secondly, GM potato does not make any sense from the point of view of nutrition as has been well argued by Ramesh Bhat and S Vasanthi of the National Institute of Nutrition at Hyderabad, in The Hindu of 24th July 2003. It is claimed that the GM potato contains 45 percent more protein than traditional potatoes. The protein content of the ordinary potato is 1.6 grams per 100 grams. Ramesh Bhat and Vasanthi state, "According to the National Nutrition Monitoring Bureau, the intake of potato by school children is about 30 grams per day". The protein intake from GM potato would thus be 0.7 grams per day which would meet the Recommended Daily Allowance (RDA) of protein only to about 2 percent in school children. Simple arithmetic would tell the reader that to meet the RDA for protein from GM potatoes alone, the children would need to consume 1.5 kg of potatoes per day! The DBT also claims that "transgenic potato leads to a high increase in all essential amino acids with corresponding increase in total protein content". These claims, as Bhat and Vasanthi also say, are not substantiated by the available data. There is also another important point that worries me. Our dietary guidelines state, "A nutritionally adequate diet should be taken through a wide choice from a variety of foods." As Bhat and Vasanthi say in the above mentioned article, "The over-enthusiasm of promoting GM technology by claiming miraculous solutions to solve malnutrition problems in India would harm the credibility and interest of the transgenic technology." Well said, but who is listening? PM Bhargava Pushpa M Bhargava is one of India's most brilliant scientists. He founded and directed the Centre for Cellular and Molecular Biology (CCMB), Hyderabad.His scientific contributions include the preparation, characterization and use of primary liver cell suspensions, and characterization of new proteins, such as seminalplasmin, from the seminal plasma. His over 70 major honours and awards include the Padma Bhushan, the Legion d'Honneur, and the National Citizens Award. ]]> <![CDATA[A public sector success story]]> https://biospectrumindia.com/news/95/4536/a-public-sector-success-story.html https://biospectrumindia.com/news/95/4536/a-public-sector-success-story.html Mon, 20 Oct 2003 12:36:00 +0530 Haffkine BioPharmaceutical Corporation Ltd, a BioSpectrum top 20 company, was the first in the country to successfully develop indigenous oral polio vaccine (OPV). The company has been increasing its turnover since 1997-98. Simultaneously it is also earning profits. In 2001-02 its sales reached a peak of Rs 86.2 crore against Rs 31 crore in 1997-98. And its profits have jumped from a mere Rs 9 lakh in 1997-98 to Rs 5.6 crore in 2001-02. Today the corporation is in a sound position as result of strategic planning and sustained efforts, which has resulted in appreciable increase in productivity and cost reduction. With the continued zeal and confidence of over 600 employees as well as the support of the Indian and Maharashtra government the corporation has been making profits and also announcing dividends to its employees every year from the past six years. Initially set up as Plague Research Laboratory at Mumbai, it was later renamed as Haffkine Institute in 1925. In order to expand the production activities and to meet the growing demand for medicines and life saving drugs, Haffkine Institute was bifurcated by the state government in 1975 and the production activities were entrusted to Haffkine Bio-Pharmaceutical Corporation Ltd. Since then, the company has been playing a pioneering role in the development and production of a wide range of bacterial and viral vaccines Besides, the company has a farm and laboratory at Pimpri where antitoxins and sera for snake and scorpion venom, tetanus and diphtheria toxins are produced. It also formulates pharmaceutical products, disinfectants, ointments, injectables, syrups and mixtures at its unit at Mumbai. The company also has a well-equipped animal house in Mumbai for breeding laboratory animals. Its motto of "service to mankind in healthcare sector" has attracted many people to its campus during the pre- and post-independence era. Haffkine BioPharmaceutical continues to focus on its core strengths since 1975, namely, oral polio vaccine, anti rabies vaccine and bacterial vaccines. Oral polio vaccine The role of polio vaccine in protecting every newborn child against the dreadful disease has been long acknowledged. The erstwhile Haffkine Institute was the first to extend a helping hand with the supply of OPV for immunization of the masses. Instead of importing the vaccine from abroad as a finished product, it imported the concentrated bulk and blended the required vaccine for production in vials for mass scale immunization. This helped to save valuable foreign exchange. The company was the sole supplier of this vaccine in the country for many years. The production of OPV has been steadily increasing over the years till 1994. It was in 1996-97 that the Government of India took up the pulse polio immunization program on a national scale to eradicate polio in India. Accordingly, Haffkine increased the production of OPV to meet the demands of the Government. The company has also received orders for supplying OPV to UNICEF. The production of OPV is carried out in a well-equipped and modern state of art laboratory confirming to the WHO standards. The OPV batches are certified by an in-house quality control department and are also endorsed by the Central Drug Authority, Kasuali, in Himachal Pradesh before supply. The company has also obtained WHO-GMP certification for its OPV facility in1999. In addition to OPV, Haffkine also manufactures Anti Rabies Vaccine (ARV) using sheep brain. The company now plans to come up with tissue culture ARV soon. Bacterial vaccine The bacterial vaccines manufactured at Haffkine are of the DPT group, namely, diphtheria, pertussis and tetanus (DPT). These components are produced individually and then mixed to give the required vaccinesâ€”DPT and DT absorbed on aluminium phosphate gel. Since the inception of the expanded program of immunization in 1978, Haffkine has been supplying increasing quantities of DTP vaccines. It has now proliferated into a key organization in the bulk biopharma production sector in India. The corporation has come a long way, from the stationary culture method to the latest fermentation technology for processing all the three vaccines (DPT) in the group. The Indian Government has duly appreciated the participation of the corporation by way of grants through UNICEF. Diversification drive The corporation established a subsidiary in 1977, the Haffkine Ajintha Pharmaceuticals Ltd at Jalgaon, in collaboration with Western Maharashtra Development Corporation Ltd. The subsidiary produces tablets, capsules, powders, ointments, etc, which are mainly supplied to the hospitals and Maharashtra government institutions. It has obtained WHO certification for certain pharmaceutical products also. The WHO certification has greatly helped the organization to increase its export turnover. With a goal of manufacturing and supplying quality health care products at reasonable prices, Haffkine is also looking at new projects. The company plans to undertake new projects and enter business alliances aimed at producing new vaccines and upgrading the technology of the existing products. This will ensure its long-term survival and continued sustained growth. Haffkine has successfully completed a lyophilization project a Pimpri for improving (confirming to GMP-WHO standards) and expanding the production facilities of anti-snake venom. It has initiated action for manufacturing anti rabies vaccines based on tissue culture (TCARV) with the transfer of technology from Pasteur Institute of India, Coonoor. It has already procured seed virus strain to manufacture TCARV and is creating necessary facilities for developing and manufacturing TCARV. It is also planning to restart the manufacturing of anti rabies serum, which is essential to prevent rabies. The corporation is considering the feasibility of undertaking other new projects like plasma fractionation, etc. To effectively meet the challenges posed by the increasingly competitive and market driven economic environment, Haffkine is laying greater emphasis on upgrading the manufacturing facilities so as to conform to the GMP standards of WHO. The company has already obtained WHO certification for its OPV product and efforts are on to obtain the same for the other existing products. To develop new products and to effect qualitative improvement in the existing ones, special emphasis is being placed on in-house R&D efforts. To implement these projects the company has envisaged a total capital expenditure of Rs 80 crore, which is proposed to be financed through additional equity infusion, internally generated funds and term loans from banks/financial institutions. Looking at brighter days With the mission to serve mankind, Haffkine BioPharmaceutical has prepared an action plan. This aims to focus on the company's strengths, overcome the present weaknesses and take maximum advantage of the opportunities available while effectively face the threats of the external environment in order to ensure continued existence and sustained growth. The dedicated workforce, an able leader to guide the organization, strong implementable strategies will definitely help Haffkine BioPharma-ceutical to lead the path of profit in the years to come and serve mankind. Narayan Kulkarni "Concerned about the future of the organization" Medha Gadgil, who is heading Haffkine BioPharmaceutical Corporation as managing director, belongs to the 1983 batch of the Indian Administrative Services, where she was the topper amongst girls and secured the 6th rank in the all India merit list. Her interest in the health care sector led her to set up the Maharashtra State AIDS Control Society as project director in 1998. In an interview to BioSpectrum, she talked about her strategy to take Haffkine BioPharmaceutical to new heights. Haffkine is doing very well compared to other public sector biopharma companies like Hindustan Antibiotics and Indian Vaccines Corporation. What is the secret of your success? We have a history of over 100 years. We have been concentrating on our core strength, i.e., the Oral Polio Vaccine (OPV). Over 75 percent of our revenue is from this vaccine. We are the key suppliers of OPV to the Indian government for its immunization program. Besides, we are manufacturing anti sera for snake and scorpion venom, injectables, capsules, oral liquid products, antiseptics and pharmaceutical drugs through our subsidiary called Haffkine Ajintha Pharmaceuticals. Our success is mainly due to a combination of factors like strong government support, support from our dedicated employees and taking the right step/initiative at the right time. India, being a signatory to the World Trade Organization treaty, will implement product patent regime by 2005. As Haffkine is producing bulk biopharmaceutical drugs with imported vaccines, what is your strategy for the product-patent regime? We are importing the OPV from Indonesia, blending it and mass-producing it in Mumbai for the benefit of the general public. So far we have not thought about this. We will think about it and take it very seriously as to how to tackle this problem. What is Haffkine's investment in R&D activities? Haffkine BioPharmaceutical was bifurcated from Haffkine Institute in 1975 to manufacture vaccines in bulk. It is purely a manufacturing company. We continue to do so. I do agree that R&D is very essential for an organization. As of now Haffkine Institute is doing R&D work. We are exploring the possibility of investing in our own in-house R&D activities. Is Haffkine exporting its biopharma products? We are exporting serum vaccines to Sri Lanka where there is good demand for our sera products. At present we are selling OPV mainly to the Indian government for the immunization program. But we are working for an accreditation, once we get that we will export OPV to other countries. Are there any significant problems that Haffkine is facing and how do you plan to overcome them? Right now we are in comfortable position but at the same time we are concerned about the future of the organization. The main problem for Haffkine is where to go from here? It is time for us to do some serious thinking. To sustain and grow in the industry we have to change the strategies that we have been following over the years. Now we are concentrating on working on new diversified projects.   ]]> <![CDATA[Customer Satisfaction: All that matters at Bio-Rad]]> https://biospectrumindia.com/news/95/2842/customer-satisfaction-all-that-matters-at-bio-rad.html https://biospectrumindia.com/news/95/2842/customer-satisfaction-all-that-matters-at-bio-rad.html Mon, 20 Oct 2003 12:24:00 +0530 Bio-Rad Laboratories Inc. was established in 1954. It was basically a brainchild of two university students, David and Alice Schwartz, who started their journey by manufacturing resins for chromatographic studies. Since then Bio-Rad has grown to become a $900 million corporation headquartered in the Bay Area in San Francisco, with its primary business focused on clinical diagnostics and life science research products. It is serving more than 70,000 research and industry customers worldwide through a network of about 30 wholly owned subsidiary offices spread in many parts of the globe. Today, Bio-Rad employs more than 4,000 professionals worldwide. A 100 percent subsidiary of Bio-Rad Laboratories USA, Bio-Rad Labs (India) Pvt Ltd is based in Gurgaon, Haryana, and has regional offices at Chennai, Mumbai, Kolkata, Bangalore and Hyderabad. Headed by Dhiren Wagle, country manager, the company is surging ahead and providing its services and products to the numerous research, industrial and clinical laboratories of India. The Indian office is also coordinating all operations in the neighboring countries of Sri Lanka, Bangladesh, Nepal, Bhutan and Maldives. Bio-Rad India has shown constant growth and its turnover has increased from Rs 21 crore in 2000-01 to Rs 33 crore in the financial year 2002-03. It is a fast-growing company dedicated to bring quality in terms of products, services and innovative ideas into the life-sciences research and health-care sectors. Informing about the latest developments in the company, Dhiren Wagle said, "In our effort to provide more strength to our regional offices, we have connected all the regional offices to the main server through VPN. This will create a direct link between the regional representatives and the head office at US. We hope that this will speed up our operations and bring more efficiency for the customer. In another effort for the same we have started managing the data on the basis of customer satisfaction and responses for our products." Informing more about products and services offered by Bio-Rad, Atul Sharma, divisional manager (services) informed, "At Bio-Rad we tend to focus on product related training programs for our customers. As a part of this, we organize seminars and build good relations with the customers. Presently, we are catering to the life sciences research industry and clinical diagnostics sector of the industry. For life sciences research we provide equipments for protein purification, DNA diagnostics, isolation of DNA, ELISA testing and several other research purposes also." "I am proud of my team which is working and giving its full knowledge skills in terms of expanding the business in the Indian market," added Wagle. Almost from the past four decades, Bio-Rad has broken new grounds by providing a broad range of innovative tools and services to the clinical, diagnostic and life science research markets. The company is world-renowned for its products among hospitals, universities, research institutions, biotechnology and pharmaceutical firms. "We have built strong customer relationships that have advanced in research and development efforts and supported the commercialization of new technology, specially in the fields of genomics, proteomics, bio-pharmaceutical discovery, food safety and biotechnology education." Wagle further added. With the expansion of the company, its customer base, global reach and product portfolio has increased substantially. Bio-Rad now manufactures and distributes thousands of products and incorporates a wide range of technologies including electrophoresis, imaging, immunoassay, chromatography, etc. By capitalizing on its expertise and quality, the company is confident in continuing to strengthen its leading role in both existing and niche markets while maintaining its position at the forefront of scientific discovery. Bio-Rad has two major groupsâ€”The Clinical Diagnostics Group (CDG) and the Life Sciences Group (LSG). Clinical Diagnostics Group Clinical laboratories throughout the world rely on Bio-Rad's clinical diagnostics business segment to deliver quality instrumentation, reagents, software and quality control systems. With the acquisition of Pasteur Sanofi Diagnostics in 1999, Bio-Rad significantly enhanced the range of its product line. In addition to its historic strengths in diabetes monitoring and quality control management, the company also provides bacteriology product testing, blood virus screening, molecular pathology, toxicology, genetic and autoimmune disorder analysis. As clinical laboratories work to simplify their purchasing processes, Bio-Rad's expanded product line provides the convenience and increased efficiency they require. Life Science Group Bio-Rad's Life Science business segment is at the forefront of discovery providing advanced tools for biological exploration. Core product areas include electrophoresis and chromatography equipment and reagents, state-of-the-art imaging instruments, image analysis software and blotting systems. This segment also supports research in molecular biology with materials for nucleic acid purification, sample preparation and gene transfer. Using these products, researchers can streamline complex procedures and improve efficiency in their day-to-day laboratory processes. Faiz Askari "Better organization in fighting diseases like diabetes is needed" Sitting and having a cup of tea with the country manager of an MNC brings a typical big-boss type image to mind. But, that is not the case with Dhiren Wagle, country manager of Bio-Rad Labs (India) Pvt Ltd. Operating and expanding Bio-Rad's canvas in the neighboring countries of Bangladesh, Sri Lanka, Nepal, etc, the confident looking manager has the desire to capture the entire market with innovation. Wagle talked at length to BioSpectrum, on the industry dynamics and developments in the company. How does Bio-Rad rate itself in the industry? What are the recent developments at BioRad India? We entered the Indian market in 1996 and since then we have had certain prioritiesâ€”to achieve customer satisfaction and to expand our business in the neighboring countries. On both these counts we have achieved excellent results. Now with the help of a skilled team, I find Bio-Rad an eminent part of the industry. In terms of recent major developments, we have given more power and liberty to our regional offices. We have done this by connecting all the regional offices directly to the main office in the US. We have six offices in major cities of India, now they can respond to the customers more quickly and independently. This will help them to develop healthy relationships with their respective customers. We have also started maintaining a product feedback record on the basis of the responses of our customers. This will help us to recognize the product's performance in the industry. Apart from building good relations with the customers what are the other focus areas of the company? We are entering into microarray technology in the life sciences section of the industry. We are offering process chromatography systems. Our BioLogic DuoFlow chromatography systems offer flexibility with multiple system configurations, many optional upgrades and common control software that is intuitive and easy to follow. Besides this we have developed a complete screening tool for the newborn childâ€“"Neonlta". With the help of this tool a child can be diagnosed for all hormonal diseases and disorders at the right stage. In India, the product is already accepted by leading medical institutes like CDFD, Hydrabad. Dr Radharama Devi of CDFD is using it and in Mumbai Dr Anil Jalan is using Neonlta for carrying tests on newborn babies. It will cost between Rs 1,000-2,000 for any parent who goes in for Neonlta tests. Bio-Rad has initiated a Quality Control (QC) program for research and pathology laboratories. How successful have you been? Our QC program is doing well and we are moving in the correct direction in this field. As of now, we have built a network of almost 200 labs all over the country. Initially, we are targeting labs, which are operating in the cities. We have categorized the labs on the basis of their competency. For example, in category 'A' we have identified about 250 labs, in category 'B' we have nearly 2000 labs in India. Right now we are not concentrating beyond these two categories. We are organizing awareness seminars and workshops in collaboration with local hospitals and have already conducted seminars in cities like Hyderabad, Coimbatore, Delhi, Patna, Lucknow and other major cities of the country. We are going to organize similar seminars in Mumbai and Pune soon. Any challenge that you foresee in maintaining quality control among the labs? Yes, there are some big challenges in running this program smoothly. The biggest is that there is no law about maintaining any standards or quality in pathology/research labs in India. In countries like the US and Australia, the laws are very stringent. The absence of appropriate laws makes us helpless sometimes. As a part of Bio-Rad's clinical diagnostics mandate, what progress has the company made into diabetes management? Bio-Rad has produced some good tools for detecting blood sugar. One example is HbA1c. The machine has the capability of detecting a patient's blood sugar level as an average of the past two months. The present day sugar detectors can only detect the sugar level at the time of test. A blood sugar test through HbA1c costs around Rs 300-400 for any patient. This certainly provides more information than what the other testing machines are offering. We have also prepared a module for doctors specializing in diabetes care so that a proper methodology can be maintained for doing the tests. Apart from this, we are going to launch D-10 model, which will do all the tests done today by HbA1c and HbA2 (thalassemia) machines. Unfortunately India has a high number of diabetic patients as compared to other countries. In terms of quality products and technology where are we standing? It is surprising to know that a small country like Bangladesh maintains records of its diabetic population. But here in India, we do not have any provision of maintaining a database of the diabetic patients. Technology wise we are strong but we have to do many things in developing a proper health infrastructure. In clinical diagnostics segment how is the company doing? This segment accords high priority in our mandate. We are expanding in this area of the industry. As of now, we are touching around 10 percent of the total market share. But we want to expand further. Similarly, in the life sciences segment, what are the strengths of Bio-Rad? I am proud of my well-qualified team in this segment. We have PhDs from good academic backgrounds. They are giving excellent support to our customers. Today we have eight PhDs who are serving the company with their skills. Which are the areas of growth and what are your future targets? The pharma industry is surging into the field of proteomics in a big way. We need to tap that segment of the market as it holds lots of potential. Although, we have achieved sales revenue of Rs 15 crore in clinical diagnostics segment, but we are eyeing to achieve Rs 19 crore by the end of current fiscal year. ]]> <![CDATA["Maharashtra is the first to look at clinical trials"]]> https://biospectrumindia.com/news/95/1036/maharashtra-is-the-first-to-look-at-clinical-trials.html https://biospectrumindia.com/news/95/1036/maharashtra-is-the-first-to-look-at-clinical-trials.html Mon, 20 Oct 2003 12:17:00 +0530 What are the infrastructure facilities being provided to the biotech industry in Maharashtra? The government has signed up with the Chatterjee Group to develop, promote and market the Hinjawadi, Pune, biotech park. The group will focus on facilities required for start-ups and existing companies, which want to improve the manufacturing efficiency of their biotech products. Further, we want to leverage the information technology strength to create a platform for bioinformatics at Pune. Like biopharma the scope and opportunity for the bioinformatics sector is huge. We see great scope in agribiotechnology. Maharashtra is known for its horticulture sector. To promote agribiotechnology in Jalna, Aurangabad, we have appointed Mahyco, which has excellent research facilities and was the first to launch Bt cotton in India. What are the promotional activities initiated the government? Biotechnology will evolve only through intellectual capital and strong human resource. We are improving the curriculum for biotechnology right from the school level and creating a greater awareness about the subject, career options and providing the right kind of the content to the industry. The University of Pune has been developed as the center of excellence with all the modern facilities. Apart from creating the good curriculum, it is closely collaborating with the industry. Further, the state government in association with CII is organizing MahabioYatra regularly every month. This is a brainstorming session for the intellectuals, industry, scientists and others. Intellectual activity takes place at the meetings, which will evolve some kind of business and also create awareness about the latest happenings in biotech world. Besides agri and pharma, which are the other areas you want to focus on? Maharashtra is the first state to look at clinical trials. The state has a vast infrastructure facility in public health sector, with over 1.2 lakh patients visiting the civil hospitals on a daily basis. We are working with the health department and pharmaceutical companies to take up clinical trails in a big way. We have all the necessary resources. We also have to focus on genetics. Today it is a cost to the state. But looking at the future we can convert this into a revenue model. The Government of India has introduced guidelines for conducting clinical trials in the country. The Biotech Commission of Maharashtra, in consultation with the pharmaceutical industry, has worked on the same and finalized the guidelines for the state. The pharmaceutical companies are discussing with the health department in this regard. This is an innovative area the state is looking at. Though companies are looking at the private hospitals for clinical trials but their client base is very small. At the public hospitals, we can provide them with a list of patients and a huge database to carry out the trials. As per the guidelines finalized by the Biotechnology Commission, the public hospitals would maintain privacy and follow ethical guidelines while carrying out the trials. We are also looking at providing facilities to carry out clinical trials on animals so that the pharma companies need not look at other sources for their new molecules. Companies like Wockhardt, Nicholas Piramal, Glaxo and Lupin are investing in biotechnology. Is the state providing financial aid to new entrepreneurs? The state has a budget proposal of Rs 10 crore for new ventures in biotechnology sector. We have already invited proposals from entrepreneurs for setting up biotech companies in the state. We are scrutinizing the proposals, so that the state support reaches the right entrepreneur. Though Maharashtra is a major sugarcane producing state in the country, why is the biofuel sector still in a nascent stage? The market for biofuel in India is still in a nascent stage. The Government of India has to create a proper market for it. Today blending of five percent ethanol with petrol is limited. Companies are discussing with Bharat Petroleum and Hindustan Petroleum to use more ethanol blended petrol in the country. Narayan Kulkarni ]]> <![CDATA[BioServices: The in thing]]> https://biospectrumindia.com/news/95/2361/bioservices-the-in-thing.html https://biospectrumindia.com/news/95/2361/bioservices-the-in-thing.html Mon, 20 Oct 2003 11:49:00 +0530 Clinical trials Clinical trials essentially involve testing a new medicine in select categories of people and are among the most time-consuming components (it may take as many as seven to nine years) in a new drug's lab-to-market journey. They consist of three phases prior to drug approval. The purpose of phase 1 is to determine how the drug acts in humans, including identifying possible side effects. If results from phase 1 trials are positive, the drug is tested in a larger group of patients to determine how it affects a specific disease and what its short-term side effects may be. Phase 2 studies focus on comparing the new treatment with the current treatment or placebo. These continue to test drug safety and are larger than phase 1 studies. In phase 3 clinical trials, the drug is further studied for safety and efficacy in a much larger group of patients. If phase 3 results are successful, a new drug application is submitted and reviewed by the FDA. Phase 4 clinical trials are conducted after a drug has been FDA approved. These studies continue to evaluate a drug's long-term effects.   With increasing pressures on R&D cost containment across the global pharmaceutical industry, there is an increased focus on reducing the cost of clinical development, which accounts for two-thirds of the development costs. This is in addition to the pressure of accelerating the pace of the entire process of drug development. These challenges have led to a paradigm shift in the approach of major pharmaceutical companies. "According to a recent study (Tufts Center for Study of Drug Development), the process of drug discovery and development takes 14.2 years (average) and costs $802 million. Clinical trials are the most significant direct costs related to drug discovery and development. The cost attached is about $282 million and takes about seven years to complete. These place significant strains on a company's resources and management time and hence significant amounts of these activities are being outsourced," said Dr Nirupa Bareja, group head (HR), Biocon India. Outsourcing has become the mantra of the industry and contract research has evolved into a huge market. India is in a unique position to tap this new business opportunity because of three factorsâ€”a large pool of qualified English speaking professionals, India's traditional strength in the pharma business and the cost-effectiveness of the study here. At present the CRO segment in India mainly consists of contract research, contract manufacturing and clinical trials. The Indian market has companies doing clinical research and trials for the molecules developed in-house (captive CRO) like Eli Lilly. And there are organizations doing contract research and trials for other companies (independent CRO) like Quintiles Spectral, SIRO Clinpharm and Syngene. Aurigene, Shantha Biotechnics and Chembiotech. Syngene International, a Biocon Group company, set up in 1994 was India's first integrated CRO in the area of drug discovery. It is presently serving over a dozen pharmaceutical R&D units in Europe and the US. "Contract research is very innovative, capital intensive, involving lots of R&D. Further, the field is not process but product-driven and cannot be operated on a large scale," said Dr Swaminathan Subramaniam, COO, Aurigene Discovery Technologies Ltd, a Boston-based drug discovery organization, with research facilities in Bangalore. Contract manufacturing has become a big industry as India offers a strong manufacturing base at competitive costs, supported by a well-developed engineering base and an abundance of scientific talent. Eli Lilly, Bharat Biotech and Shreya Biotech are some of the important contract manufacturing companies. Besides contract research and manufacturing, India is also emerging as a global hub for clinical trials. "India is being projected to grow in this field on account of adequate patient population having a wide spectrum of diseases, from common to the rarest, qualified medical professionals, good communication network and IT capabilities," said VV Raghavan, managing director, Lotus labs, an independent Bangalore-based contract research organization. "Clinical trial is a very data and quality-intensive work and may involve high percentage of travel. The scope of any error is very limited and involves high degree of ethics both personal and professional," commented Rajiv Gulati, managing director and chairman, Eli Lilly and Company (India) Pvt Ltd. Quintiles, Specialty Ranbaxy, Siro Clinpharm, Eli Lilly, Clingene International (a subsidiary of the Biocon India Group), Lotus labs, Clintec International, Pfizer, Novo Nordisk, Lambda Therapeutic Labs, Novartis, etc. are some of the companies conducting clinical trials in India. Goldmine for students The Contract Research Organization (CRO) market has great potential and offers tremendous career opportunities. "The Indian CRO market is currently growing at 20 percent per annum and has excellent growth opportunities," said VV Raghavan of Lotus Labs. "Market trends indicate that the CRO market is going to experience rapid growth in the coming years and will become an indispensable part of the drug development process. The CRO industry is a major employer of medical and scientific staff and hence the demand for qualified personnel is on the increase. The potential is huge and the opportunities exist at every level," commented Nirupa Bareja of Biocon. "The potential is for real, the opportunity could be as big as 150 crore in year 2007-08," said Rajiv Gulati of Eli Lilly. "As on date, clinical research is still a sunrise industry in India and contributes just 0.7 percent to the global clinical research industry but this scenario is soon expected to change. India is tipped to be one of the major hot spots for clinical research in the coming decade. Analysts estimate that by the year 2010 India would contribute 20 percent to the global clinical research industry revenues," said Shamiq Hussain, general manager, Clintec (India) International, a Europe-based CRO. This optimism is bound to translate into a huge job market for the students. "At Biocon India in addition to the technical competency, we look for a scientific analytical temperament in an individual. They must also be result-oriented, team players with good interpersonal skills, innovative, performance-driven, leadership-oriented, creative out-of-the-box thinkers and passionate about the job," commented Nirupa Bareja, group head HR, Biocon India. In most of the companies, the standard procedure of selection is that resumes are received as a result of advertisements and walk-ins, which are screened and candidates further short-listed for an interview. "From a selection perspective, we follow a well-defined process. Based on the annual manpower planning, the recruitment is planned division-wise and the review of this is done on a quarterly basis. The short-listed candidates are interviewed both at Biocon and at various campuses. The interviews include both written tests (technical and aptitude) and personal interviewing," said Nirupa Bareja of Biocon. She added, "From a qualifications perspective, we look for post doctorates, doctorates, medical doctors, post graduates in the fields of organic chemistry, molecular biology, microbiology, biotechnology, pathology, biochemistry, pharmacology, etc. depending on the job profile. At Biocon India in addition to the technical competency, we look for a scientific analytical temperament (as a mandatory quality) in an individual. They must also be result-oriented, team players with good interpersonal skills, innovative, performance-driven, leadership-oriented, creative out-of-the-box thinkers and passionate about the job." This sentiment is echoed by most of the company heads. "We look for candidates having flexible thinking, a confident attitude and an aptitude for learning about other fields besides their core area," said Dr Swaminathan of Aurigene. "We look for aspiring candidates who have a desire to learn and grow in this field" commented VV Raghavan of Lotus labs. "In the contract industry, the people should be highly skilled and versatile to take up different projects and execute them at low cost in order to be competitive and effective," was the opinion of Raman Akella, head administration, Shantha Biotechnics, Hyderabad. Recruiting by way of referrals, headhunters, advertisements, CVs received electronically and by mail is the norm. But many companies also go to premier institutes like NCL Pune, IITs, and IISc to recruit. At the entry level prior experience is not always sought, though is sometimes preferred. The manpower requirements for each project could vary and range from two people to a hundred people per project. "The manpower need is typically dependent on the extent and the nature of outsourcing which is done to the CRO and is also dependent on the phase of the clinical trial work undertaken," observed Rajiv Gulati of Eli Lilly. "Clinical trial is a very data and quality-intensive work and may involve high percentage of travel. The scope of any error is very limited and involves high degree of ethics both personal and professional," commented Rajiv Gulati, MD and chairman of Eli Lilly India. In any CRO, the job categories depend on the nature of the contract service undertaken. Scientists in the field of synthetic organic chemistry, molecular biology and bioinformatics are required at Biocon. Aurigene looks for screening pharmacologists, chemical researchers and experts in the field of genomics, computational biology and bioinformatics when the project is in the initial stage of drug discovery. A few job categories at Shantha Biotechnics include fermentation, purification/process analysts (technical), quality assurance, registration/documentation personnel (regulatory), plant and process, quality assurance, operations personnel (management) and medical advisors. In a company conducting clinical trials, the job categories could be multifaceted like coordinator, monitor, clinical investigator, research associate, clinical research physician, analytical chemists trial materials manager, project manager, medical writers, data managers, documentation personnel, lab technicians, and statisticians. In this segment, growth prospects are excellent and are performance related. The salaries are very attractive and much above the average salaries in the medical sector or pharma industry. Employees are given every opportunity to excel, challenge boundaries, and go beyond expectations with sky being the limit. In the CRO sector on an average the men to women ratio is about 4:1. Rolly Dureha   ]]> <![CDATA[Bio Products October]]> https://biospectrumindia.com/news/95/2940/bio-products-october.html https://biospectrumindia.com/news/95/2940/bio-products-october.html Mon, 20 Oct 2003 11:00:00 +0530 Wosulin Wosulin-first recombinant human insulin from Wockhardt Wockhardt Ltd has launched Wosulin, India's first recombinant human insulin. It has been developed using the latest yeast-based technology, which is believed to be superior to the earlier method based on E.coli bacteria. This recombinant human insulin avoids the risks of viral infections like Bovine Spongiform Encephalitis (BSE), Transmissible Spongiform Encephalitis (TSE), Creutzfeldt Jakob Disease (CJD) and other neurological disorders associated with insulin derived from animals. Wosulin was approved by the regulatory authorities after it proved its efficacy and safety in clinical studies involving 350 diabetic patients, conducted by leading diabetic experts at reputed medical institutions across the country. It is available at Rs 129 per unit. For further details, contact: ocassubhoy@wockhardt.com Pharmalab brings Isolator Technology to India Pharmalab has brought Isolator barrier technology to India for pharmaceutical and biotech industries by joining hands with the Canadian company Isotech Design. The isolators, microenvironment and mini-environment systems of Isotech offer a cost-effective solution versus traditional clean rooms to manage sterility, control microorganism and particle contamination and provide containment management. The sterility tests eliminate the risk of a false positive. The aseptic filling eliminates the risk of high start-up costs, extended deadline and possible contamination in small volume and pilot scale aseptic filling. It also helps in eliminating the risk to the operator while handling toxic powders and compounds. For further details, contact: santej@pharmalab.com Automed launches ChemScan®RDI in India ChemScan®RDI is a real time microbiology analyzer. With its unique combination of speed and sensitivity it represents a revolution in microbial detection. ChemScan can deliver direct cell counts down to one colony forming unit (cfu) in less than 90 minutes for bacteria and fungi. Even spores, stressed and fastidious organism can be detected within 90 minutes. The analyzer is based on the technologies of fluorescent labeling and laser scanning. It supports microbial identification using specific probes and its non-destructive method leaves scope for further confirmation. The food, pharmaceutical, cosmetic, biotech, chemical and electronic industries, besides the research and development labs can use ChemScan for their various products. More than 150 units are already placed in Europe, the US and Japan in routine laboratories of varied industries. For further details, contact: sales@automedsystems.com FBL introduces latest version of PGA Biocatalyst Fermenta Biotech Limited (FBL) has introduced the latest version of Penicillin G Amidase (PGA) biocatalyst known as PGAâ€“Fermenta 2, in a polymer support with high specific activity, improved operational stability and economic advantages. FBL has pioneered manufacture of PGA biocatalyst in India, which is a vital enzyme used for splitting Penicillin G and Cephalosporin G into respective drug intermediates, like 6-APA and 7-ADCA. Fermenta 2 is a purified enzyme mount on macroporous polymer beads. Though PGA enzyme catalyst can be used for 7-ADCA and 6-APA, it is recommended for the manufacture of 6-APA. For further details, contact: jambunathan@fermentabiotech.com New information management solutions from Accelrys Accelrys has announced the release of its latest solutions for chemical and biological information management: Accord Enterprise Informatics and DS Accord for Excel Enterprise. Accord Enterprise Informatics 5.3 is an information management solution designed to enable the sharing and management of data among multi-disciplinary scientific functions in pharmaceutical or biotechnology organizations. New features include support for Linux and OracleÃ‚® 9i, significant performance enhancements, and support for a standard customization language: PL/SQL. DS Accord for Excel Enterprise 5.2 is a cheminformatics tool for managing, visualizing, and analyzing chemical information, and also acts as a PC-based client interface for Accord Enterprise Informatics 5.3. For further details, contact: aginsberg@accelrys.com E series of UV water purification systems from Alfaa Alfaa, an ISO 9001 organization dealing in critical process water applications has introduced the E series range of UV water purification system for light commercial application like drinking water, rinsing, washing, dialysis, ice cubers, etc. UV water purification is preferred the world over because it is the simplest and most practical means of destroying disease-causing microorganisms without changing the physical and chemical characteristics of water. The E series uses UV chamber of stainless steel 316 material for high corrosion resistance, uses quartz glass technology for superior UV transmission, imparts dosage of more than 30,000uwsec/cm2 for disinfecting efficiency of 99.9 percent. For further details, contact: jain@alfauv.com ]]> <![CDATA[Measure and be Measured]]> https://biospectrumindia.com/news/95/2655/measure-and-be-measured.html https://biospectrumindia.com/news/95/2655/measure-and-be-measured.html Fri, 26 Sep 2003 15:51:00 +0530 There is an old Chinese saying which roughly translated says "what cannot be measured cannot be improved". This issue of BioSpectrum is the first attempt to put a measure on an industry that is changing shape rapidly. Not only that, its potential to shape the world of tomorrow is even more immense. This issue is the first attempt to measure this industry in India. We believe that this will become a benchmark for checking out the future growth of this industry. In many other industries, trade bodies, industry associations or government agencies collate and present this data. These sources do not exist for the biotech industry. So we decided that we would not remain mere reporters but will also turn into market researchers. Not that this is the first such task that we have undertaken. Some eighteen years back when CyberMedia published the first survey of the information technology industryâ€“actually it was called the computer industry thenâ€“there was a high degree of sceptism. Questioned were the utility of the exercise to its credibility. For the researchers there was no past data to fall back upon and most of the companies were small and unlisted. So there was no published data available. In many cases, the computer industry was the least computerized and it did not have the breakups that we requested. In fact, at least, half a dozen marketing chiefs and CEOs confided in me that Dataquest's (the magazine that published the reports) information collection helped them understand their operations once a year. The industry was so busy in growing that it had no time to measure itself. The driving force behind many of the companies was a little more than having a spare room to do business from. The classifications and categories were fuzzy. Nevertheless, with the help of dogged determination and plain cussedness, the DQ Top 10 emerged. It made people sit up and take notice. Not because the industry was hugeâ€“Rs 100 crore or some such figureâ€“which today is lost in the rounding off of a Rs 75,000 crore industry. But because it had been given a size, a shape and an identity. Based on this, the magazine earned the title the Bible of the Indian IT industry. From then that issue of the magazine Dataquest has been a sellout each year. It has grown along with the industry and today spans 4 issues in the months of July and August. With this issue, we hope to give the biotech industry in India a shape, a size and an identity. By contrast, the BioSpectrum Top 20 is starting on a much stronger footing. The industry has some 150 serious players and revenues of Rs 1,830 crore. It has some defined segments like biopharma, bioagri, bioindustrial, biosuppliers and bioinformatics. The investment in the industry during the past year was Rs 650 crore with upwards of 6,000 people employed in it. And it has data to share. Certainly more than what IT had! The data has been complied from questionnaires that were sent out and through extensive discussions with experts in the industry itself. Not everyone responded to our data requests and some of those who did provided only partial information. Nevertheless the overall response has been very positive. Once the utility is established, we are sure we will have a much higher level of participation. We do hope that the biotech industry will appreciate that this is the first effort of its kind and there could be omissions. We are measuring the industry and are completely ready to ensure that we measure up to the task. We will be grateful that these are sent to us in as many numbers as possible so that the quality of data can be improved for the future. In the meantime please treat the omissions as they areâ€“sins of omission rather than commission. In future issues we hope to carry more and more industry related information which will help our readers keep themselves updated and informedâ€“and ahead. Shyam Malhotra shyamm@cmil.com Editor in Chief CyberMedia ]]> <![CDATA[Surging Ahead]]> https://biospectrumindia.com/news/95/2734/surging-ahead.html https://biospectrumindia.com/news/95/2734/surging-ahead.html Thu, 25 Sep 2003 14:29:00 +0530 Genta Inc. is a small biopharmaceutical company based in New Jersey. News has just come in that its anti-cancer drug Genasense has increased the life of patients undergoing chemotherapy by at least a month in clinical trials. The US drug regulator FDA is nowadays very quick in granting approvals to such drugs, which may improve the life of cancer patients. And if the drug can hit the market quickly, there is at least a $1 billion global opportunity awaiting the company. No wonder, the French pharmaceutical giant Aventis last year paid $135 million (Rs 620 crore) upfront and agreed to pay overall $480 million (nearly Rs 2,000 crore) for all the rights to this drug. Similarly, Avesthagen, a Bangalore-based biotech hot $ shop, has just announced the filing of a patent to a new basmati rice strain which will eliminate various constraints in the growing of one of the world's most sought after rice variety. Avesthagen too is now a much sought after company. Such companies are the mascots of the biotechnology sector. From the inaugural issue in March, BioSpectrum has been trying to focus industry and public attention on the new wave of entrepreneurs who have been in the thick of things to develop cutting edge biotech products and services. Without waiting for long, we plunged into the highly arduous task of mapping the contours of the biotech industry. And who else could have been the best partner in this endeavor other than ABLE (Association of Biotechnology-Led Enterprises) which too started early this year to give the industry the right voice, to be heard above the din of public discourse. Together, we have worked closely for the last three months to bring out the first-ever survey of the biotechnology industry. What the joint efforts have revealed is heartening. The industry size of Rs 1,830 crore ($400 million) is by no means small. More important is that the growth prospect of this industry is really bright. Majority of the companies have started operations in the last five years and are in the development phase. The industry is gathering critical mass and the take off which could happen in a few years could be momentous. The four distinct segments, biopharma, bioagriculture, bioservices and bioinformatics are backed by very strong biosuppliers and bioindustrial sectors. Being a strongly research oriented sector, biotech has a high proportion of highly educated employees and nearly a fourth of the employees are women in the leading companies. In recent months, BioSpectrum has highlighted the bioactive areas of the country, hurdles in the growth path of biotech and the funding requirements. This issue has ranked the companies on the basis of revenues. In the coming years, as pure-play biotech companies hit the market with their pioneering products and ramp up revenues, the BioSpectrum-ABLE index is most likely to undergo radical movements. We hope the industry dynamics will continue to keep us on our toes in bringing these happenings in a compact form for decades to come. sureshn@cmil.com ]]> <![CDATA[Momentum of Growth]]> https://biospectrumindia.com/news/95/2098/momentum-of-growth.html https://biospectrumindia.com/news/95/2098/momentum-of-growth.html Thu, 25 Sep 2003 13:18:00 +0530 Beyond Borders-The Global Biotechnology Report 2003 is Ernst & Young's second global biotechnology report and 17th in the firm's series of widely acclaimed, award winning regional annual biotechnology reports. The report looks at the state of the global industry, the key drivers and the discernible trends and opportunities. The first edition of Beyond Borders in 2002 was the result of our conviction that the biotechnology industry had transcended national boundaries and regional confines to acquire a truly global character. Our first global report therefore expanded upon our successful US and European focused reports, which had been in print for 15 years and 8 years respectively, to include an analysis of Canada, Asia Pacific and some of the world's developing markets. We not only illustrated a detailed local view, but also put that information in a global context. Our reports have earned recognition, reliability and respect from the industry because of the high standards and stringent criteria we use in qualifying companies as biotech companies. Ernst & Young defines biotechnology companies as companies that use modern biological techniques to develop products and services to serve the needs of human health care or animal health, agricultural productivity, food processing, renewable resources or environmental affairs. Medical device, large pharmaceutical and large agribusiness companies are outside the scope of our report. Our report has been hailed as the "bible of the biotech industry" by Carl Feldbaum, president of the Washington, DC-based biotechnology industry organization, the leading industry association representing more than 1,000 biotech companies and research institutions in the US. Ernst & Young's ties with the biotechnology industry are almost as old as the industry itself. The firm's global biotechnology practice was founded in the San Francisco Bay Area in the early 1970's and represented pioneering biotech companies such as Genentech and ALZA in their IPOs-the first ever in the sector. Ever since, E&Y has been the dominant professional service provider to biotechnology companies across the globe. The firm has demonstrated an unwavering long-term commitment to the support and advancement of the biotechnology sector for over 25 years. This has come about through a strong team of professionals with an expert understanding of the key industry drivers and a strong legacy of thought leadership. Our firm has more than 3,000 people who have worked in the health sciences industry. Among them are scientists, molecular geneticists, and doctors, who have real world experience and understand the full spectrum of business and scientific issues specific to the industry. Ernst & Young's global biotechnology practice has evolved and transformed over the last three decades with the growth of the industry. Its highly incisive state-of-the-industry reports have not only monitored important events and analyzed trends through well-researched data on the industry, but have also presented a broad overall perspectiveâ€“a gestalt, which makes sense of the multitudinous and highly dynamic facets of an ever-changing industry. Our firm's high level of engagement and involvement with biotechnology leaders has enabled our experts to have an unmatched understanding of the issues that affect the industry's fundamentals. We know our clients' customers, alliance partners, suppliers and competitors. Our depth and breadth of coverage of the entire biotechnology value chain has allowed us to offer broad and value-adding ideas and insights. This understanding and knowledge has in turn enabled our firm to be the industry's partner in progress. Since our firm is well connected within the financial community, we know the bankers, venture capital firms, financial companies and angel investors and we can help our clients steer through the financing uncertainties with ease. E&Y has also made the necessary investments to have a deep and thorough understanding of the regulatory and legislative side of the biotech business. This makes us better able to help our clients navigate the regulatory pathway to get their products to market. The annual biotechnology report is not merely a publication. It is an occasion for our firm to reiterate its long-standing commitment to the industry and also to refresh and renew our learning. The process of putting the report together is a highly rewarding experience for the firm's professionals as they get the opportunity to interact with a wide range of stakeholders in the industry including business leaders, venture capitalists, investment bankers, scientists, innovators and academicians. In essence, it is a process of establishing communication, sharing information and building relationships. The report is also an opportunity to showcase the industry's limitless potential to investors and to delineate opportunities for investment. The report has been with the industry through its crests and troughs and has been a harbinger of hope by upholding biotechnology's promise even in times when the chips were down and investor confidence was low. It has done this by spotting the winnersâ€“be they products, technologies, business models or companies themselves. Our report has in essence been a tribute to the spirit of innovation and entrepreneurship in the biotech industry. From our perspective, the report has enabled the firm to further build on its industry credentials and broaden its reputation as a biotechnology leader globally. It has also helped the firm to leverage its image as a partner of leading biotechnology companies and create a basis for initiating dialogue and developing new client relationships. Watch out! The overarching theme of our global biotechnology report this year is survival and success. What the future holds for the global biotech industry may be summarized as: It is an industry poised for success, as fundamentals are strong despite financing challenges. The industry is witnessing a dramatic shift in consolidation and mergers as companies are building a network of alliances to spread risk and reward of drug development among a number of companies. Global alliances and harmonization are proving to be the key to market success as biotech and pharmaceutical companies are spanning the globe for broader markets to sell their products and for the best R&D alliance partners. From an Indian perspective, following are some of the discernible current trends: India's significance for global players is increasing: Quintiles recent scale up of its Indian operations, Chiron's tie up with an Indian company for developing its AIDS vaccine and Covance's alliance with Siro Clinpharm illustrate this growing trend. Indian companies are demonstrating global capabilities: Two examples are Biocon's emergence as an integrated biotech player through an alliance with the Cuban biotech institute, CIMAB, and Strand Genomics' licensing of Sphatika to San Diego-based Syrrx. National laboratories are becoming more market driven: In the last year, CSIR has taken several initiatives to commercialize research and enter into mutually rewarding partnerships with industry. The launch of a bioinformatics solution-PLHost by the Institute of Genomics & Integrative Biology (IGIB), the TATA-CSIR initiative for Bio Suite, IGIB's tie-up with the Chatterjee Group to form the Center for Genomic Services (TCGA) are indicative examples of this growing trend. Biotechnology activity is growing respectably despite poor VC support: This is a result of the proactive involvement of national research laboratories and greater industry-academia ties. The wholehearted support of state governments to promote biotech investments in their states has been a major driver as well. We are also seeing a trend towards cooperation among industry players such as the joint venture between Shantha and Biocon for human insulin. These kinds of alliances are expected to maintain the momentum of growth. Implications for the future Collaboration between research labs and companies will bring in more new products to the market India will attract a much larger piece of the outsourced R&D pie. Number of internationally approved manufacturing facilities will increase. There will be a trend towards alliances between India and other developing countries to cooperate on mutually relevant technologies and areas of interest. Arriving at the future It is imperative for national labs to move from patents to products. Governments have to provide impetus to biotech parks on the same lines as software technology parks. Globally, the brand of India Inc. has to be positioned more effectively by emphasizing quality and available skill-sets rather than low costs alone. Embracing a globally relevant IPR regime will be the key to investment. Utkarsh Palnitkar (The author is the head of life sciences practice of Ernst & Young, India)     ]]> <![CDATA[Handshake, a Must]]> https://biospectrumindia.com/news/95/1802/handshake-a-must.html https://biospectrumindia.com/news/95/1802/handshake-a-must.html Thu, 25 Sep 2003 13:07:00 +0530 The Indian pharma and biotech sectors are poised for an explosive growth over the next decade. The combined size of these two can grow five-fold by the year 2010 to reach $25 billion from the present $5 billion. This is to quote a comment made by Sankar Krishnan, partner to McKinsey & Co., in a well-known publication recently in Mumbai. The growth is likely to take place against the backdrop of a fast-changing global pharmaceutical scenario. The present trends suggest that more and more pharma companies are diversifying into the biotech sector. India is becoming a key source and market for biopharma. When several big drugs go off patent in the coming years, pharma companies from all over will be getting into this market quickly through the biotech mode. The bio-generic drugs are estimated to replace 70 percent of the conventional therapies by 2025. The recent major structural shift in the pharma industry has resulted in new challenges for Indian companies. The ever-increasing size of drug companies resulting from continuing merger proposals is giving rise to unprecedented R&D budget for various multinationals. Unfortunately, many of the biotech companies are small and fragmented unlike the pharma industry. Mergers may lead them to outsource their R&D. It is time that Indian pharma companies in the country invest in productive R&D partnerships with biotech companies where original discoveries become viable products. The vast potential of the Indian herbal drug industry languishes due to the disinterest shown by the Indian pharma companies in the multitude of opportunities. The biopharma sector is undergoing a major transition, perhaps the greatest since it began. The global biopharmaceuticals market is estimated at Rs 33,000 crore and is said to be growing at the rate of 15 percent annually, in a scene dominated by global majors. This sector is very dynamic and for those companies willing to adapt flexible strategies, there are many opportunities ahead. Strategic tie-ups between big pharma companies and small biotech start-ups are already happening for contract research and manufacturing. With over 350 biotech drug products in the pipeline across the world, this is also the chance for Indian pharma biotech companies. By 2005, the Indian market for recombinant medicine is also tipped to grow from Rs 535 crore to Rs 958 crore. Investments into biodrugs are also expected to grow to Rs 500 crore. Currently, four companies are into making the hepatitis B vaccine and several pharma companies have active biotech plans. It would be wise to have synergy between the pharma and biotech companies to avoid cannibalisation and killing of effective products. The pharma industry should not lose focus at the market place. "Learning" processes and the ability to change approaches and objectives to exploit new opportunities are the essential strategies. Companies like Bharat Biotech need to base themselves on the highest scientific skills that they can gather. Excellence in science alone, however, is not enough. It also needs entrepreneurial technology management and marketing coupled with entrepreneurial fund raising. Concerns and Issues One of the key concerns is about R&D. Many of our scientific leaders like Dr RA Mashelkar, Dr Manju Sharma and Dr VS Ramamurthy are all visualizing India to be the hub for R&D in the region. Indian biotechnology should leverage the IT strength displayed by the Indian software industries. Further due to the availability of human genome project data, India is in a position to develop new products that are globally acceptable. Keeping this in mind, biotechnology in India is now focussing on knowledge creation and retention. A think tank comprising of visionary groups from academia and industry to strategize the work plan for next five years is also being contemplated. R&D alliances of various types are increasingly becoming a fact of life in the biotech industry. Underlying this trend is the general understanding that now a days no company or organization holds all the pieces of the complex jigsaw that together make up the picture of new profitable products. Increasingly, business success depends upon the ability of bioentrepreneurs to bring all these pieces together and to use them collectively to make profitable products. An important feature of alliances is that they are often task-bound. The significance of this feature is not that partners eventually fallout with each other and go their separate ways, but rather that partners come together because they have some shared interest and complimentary resources and competencies. In other words, each partner holds part of the jigsaw. Once a specific problem is solved or a product developed and commercialised there is no binding reason for the alliance to continue. The skill of a bio-entrepreneur is to be able to draw all these pieces together for just long enough to achieve a goal and then to reconstruct new alliances around new problems or opportunities as they arise. An important aspect of this being that research may need to change direction and this may require a reassessment of the resources and competencies that may be needed in future. Patterns of partners can change. There is a common perception that intellectual property rights (IPR) are a major concern in R&D alliances. While It is true that contractual agreements need to be concluded before R&D alliance or manufacturing alliances can start, but the criticality of formal IPR agreement in my experience is that technology is advancing so quickly that going for watertight IPR protection, particularly of technology processes is often simply not feasible. In most successful R&D alliances, more often than not, trust was the worthy substitute for formal IPR protection. In unsuccessful alliances, IPR protection alone did not protect the companies. IPR and emerging patent problems in India Many processes and gene components used in biotechnology are subject to intellectual property claims through patenting and plant variety rights. Dr RA Mashelkar, Director General, Council of Scientific Industrial Research, reiterated the importance of IPR in the context of WTO and gave a strong wake-up call to the ignoramii of IPR's importance. His awareness program has brought about a change in the mindset of our scientific community. Some western companies do not want to share technology with developing countries like India due to IPR protection. This type of intellectual isolation will hurt equal opportunities in the global society. Restriction of this kind will tempt entrepreneurs of developing countries to seek alternative methods. It is wise that companies from developed and developing world work together, thus safeguarding IPR for benefit of the society. In a controversial move some US companies whose patents are expiring are trying to extend the patent life. TRIPS does not respect the extension of patents in healthcare though. Regulatory issues India is undergoing the learning curve in regulatory issues. Unfortunately, biotech industries face five central ministries, six state ministries and 14 committees of both centre and state governments. This results in inordinate time-delays. In addition, the committees are not being stringent. This is resulting in lack of transparency in discussing the technical issues. The Indian Government should think of setting up a national level organisation independent of the government consisting of a think tank of academicians and industrialists to frame guidelines, policies and strategies for promoting research, development and production of biologicals. The organization can follow the model of CBER under US-FDA. Bioentrepreneurship Setting up and running a company requires teamwork and trust. In the last 25 years, science has metamorphosed into a viable business. While I was a graduate student at the University of Wisconsin-Madison, the business aspect was initially viewed with curiosity and doubt. After the introduction of the concept of incubator/science or research parks, the universities saw the emergence of bioentrepreneurs. This bioentrepreneurship changed the way science has been thought of in the US. It is gratifying that similar opportunities are gradually emerging in India. Trends Some of the leading Indian pharma players will make the transition to large globally successful companies. In addition, mid-size but high value research focused companies will emerge. Others may be forced to play a low value game to survive. Innovation-led businesses in India consisting of new drug discovery, R&D services, will be as large as $5-7 billion by 2010. India's current base of the domestic market, global bulk and generics will present an $18-19 billion opportunity by 2010, up from $6-7 billion currently. The forthcoming years will belong to bio-drugs like the human insulin, Streptokinase, recombinant hepatitis B, vaccines and diagnostics. Major investments will go into bio-engineered drugs for diseases from diabetes and cancer to HIV/AIDS, malaria and tuberculosis. (Dr Krishna M Ella is the Chairman and Managing Director of Bharat Biotech International Ltd (BBIL), one of the leading research-based firms in India. BBIL was established with the objective of providing affordable solutions to health problems in developing countries.) Dr.Krishna M.Ella ]]> <![CDATA[Suicide Trap]]> https://biospectrumindia.com/news/95/1225/suicide-trap.html https://biospectrumindia.com/news/95/1225/suicide-trap.html Wed, 24 Sep 2003 16:23:00 +0530 Ninety-five percent of the new science in the world is created in the countries comprising only one-fifth of the world's population. And much of that scienceâ€¦neglects the problems that afflict most of the world's people. â€” Kofi Annan  in Science, Mar 7, 2003 It is a sad reflection on the way modern science has grown. Nothing can be more tragic for the five-sixth of  the world's population that has been forced to accept science and technology that has actually not been developed for them. Still worse, what Kofi Annan probably forgot to say was that the biggest tragedy of modern times is the way countries have allowed industries to control and manipulate science. No, I am not talking about Prime Minister Atal Bihari Vajpayee's promise of sending an Indian to the moon at a time when 320 million people go to bed hungry, but promoting the sunrise industryâ€“genetic engineeringâ€“in the name of science and technology. And still worse, diverting scarce public resources to subsidize an upcoming industry, allowing democratically elected state governments to make available prime land for the new industry and that too at a pittance, announcing tax holidays and other financial relief measures. Well, you should know that subsidy is only a dirty word when the public money is spent for the poor. The rich and elite have an inherent right to government support and knowing that the term subsidy is not politically correctâ€“they call it an 'incentive' for growth. Whether it is Andhra Pradesh or Karnataka or Punjab, chief ministers are not only doling out public resources for a risky and unproven technology but are unabashedly promoting such technology parks by diverting public funding and services meant for the poor. There is no dearth of resources for setting up biotechnology parks occupying prime land in the heart of the cosmopolitan cities. However, at some places, a lot many of the original allottees find it a lucrative real estate business. A majority of biotechnology companies that are coming up are essentially subsidiaries of the foreign companies and institutes or else are serving merely as a service industry for the companies abroad. Like the IT industry, the emphasis on intellectual property is conspicuously missing. As far as agriculture is concerned, where the controversy is at its peak, most of the companies are only trying to duplicate and sell the genetically modified seeds that have been developed outside the country. Such is the great rush for profits that these companies are not even aware of the specific needs of the Indian farmer. All they know is that they need to make a fast buck. Given the blind political support, considering that elections have begun to happen more frequently, these biotech and seed companies find a green pasture in India. This may however not last long. Every day is not a Sunday and it will be tragic if the biotech industry refuses to see the growing anger and social unrest in the rural areas following the Bt cotton debacle. The industry therefore must redesign its approach, re-ensure the utility and relevance of its technological products and work on technologies that help farmers move away from the suicide trap into more sustainable farming practices. But before that, the government must stop subsidizing the biotechnology industry in the name of science and technology and set rules and regulations that do not allow these companies to walk away with sub-standard products and public liabilities. And like Kofi Annan said, the most important question that the biotechnology industry needs to ask is whether the genetic modification technology is relevant to India's farmers and consumers. Merely multiplying and selling GM seeds produced outside the country will for sure pit the industry in direct confrontation with farmers. And that will be suicidal for the industry. ]]> <![CDATA[Global bio-clusters]]> https://biospectrumindia.com/news/95/4293/global-bio-clusters.html https://biospectrumindia.com/news/95/4293/global-bio-clusters.html Tue, 12 Aug 2003 11:17:00 +0530 The purpose of this survey was to get a better understanding of the government initiatives, institutional research capacities and national focal points and strategies directed at the biotechnology sector. While other sources provide good information on the commercial, corporate and capital market ends of the biotechnology community, this survey aimed at recording and analyzing the sector's grassroots features of research, collaboration, infrastructure, technology transfer, and commercialization capabilities that serve as the underlying framework from which innovation and discovery grow. From this examination, several themes and insights emerge as to the strategies being employed by countries to domestically and globally position themselves in the biotechnology area. Biotechnology is getting biggerâ€¦ and so is pharma Asia-Pacific Australia No of biotech companies:190 (150 private, 40 public) BioClusters: Sydney, Brisbane, Adelaide, Perth Government Funds: $2.9 billion for research in 5 year China No of biotech companies: 50 BioClusters: Beijing, Shanghai Government Funds: $740 million   Hong Kong No of biotech companies: 3 (all public) BioClusters: Hong Kong City Government Funds: $65 million   Israel No of biotech companies: 165 (160 private, 5 public) BioClusters: Tel Aviv, Jerusalem Government Funds: $100 million via Israel Japan No of biotech companies: 55 (40 private, 15 public) BioClusters: Kanto, Kansai, Tokyo Government Funds: $2.4 billion in 5 years   New Zealand No of biotech companies: 30 (20 private, 5 public) BioClusters: Auckland, Dunedin Government Funds: $500 million Singapore No of biotech: 25 BioClusters: Singapore city Government Funds: $1.5 billion plus $ 600 million in BioMedical Sciences Investment Fund   Taiwan No of biotech: 50 (45 private) BioClusters: Taipei, Hsinchu Government Funds: $1.6 billion in 5 years   Americas Canada No of biotech: 415 (330 private, 85 public) BioClusters: Montreal, Toronto, Vancouver, Alberta, Nova Scotia, Saskatchewan Government Funds: $1.5 billion in 2002   Brazil No of biotech: 300 BioClusters: Belo Horizante, Sao Paulo, Rio de Janeiro Government Funds: $50 million   Europe Belgium No of biotech: 70 (65 private, 5 public) BioClusters: Brussels, Wallonia, Liege, Flanders Government Funds: $520 million   England No of biotech:  310 (265 private, 45 public) BioClusters:  London, Cambridge, Oxford Government Funds:  $3 billion plus $1.5 billion in 2004   France No of biotech: 240 (230 private, 10 public) BioClusters: Paris, Strasbourg, Grenoble, Ferraud, Bordeaux, Toulouse, Montpellier, Marseilles, Cote d'Azur Government Funds:  $1.6 billion   Germany No of biotech: 365 (340 private, 15 public) BioClusters: Munich, Rhineland, Baden Wuerttenberg, Brandenburg Government Funds: $2 billion   Ireland No of biotech:  30 (27 private, 3 public) BioClusters:  Dublin, Cork, Galway, Maynooth, Tallght Government Funds:   $2.5 billion upto 2006   Scotland No of biotech: 86 BioClusters: Glasgow, Edinburg, Aberdeen, Dundee Government Funds: $60 million Sweden No of biotech:190 (180 private, 10 public) BioClusters: Stockholm/Uppsala, Medicon Valley, Goteborg Government Funds:    $ 425 million plus $ 2 billion in 15 years through Stockholm BioSciences Initiative   While the "average" biotechnology company in almost any locale could be described as small, private and unprofitable, several entities (namely in the US and a few in Europe) are large corporate structures with products in the market generating hundreds of millions in revenues and wielding the financial clout (for R&D mergers and acquisitions) traditionally reserved for pharmaceutical players. For the US-based firms, this means more financial flexibility, more investment opportunities and a more global outlook. For international biotech concerns, this means more chances for cross-border collaboration, a wider array of product development, financing options and greater market entry opportunities via partnerships. At the same time, the pharmaceutical industry is evolving to one dominated by an ever-smaller group of giant, global corporations that continue to merge with and/or acquire one another in an ongoing consolidation effort to create critical mass, reach key markets, enhance product pipelines and deepen/broaden their in-house research capabilities. The significant growth in the size of participants in the closely-tied biotech and pharmaceutical segments is opening up new opportunities as outsourcing activities create demand for specialized laboratory and testing facilities, information technology providers and other customized services. Nations investing billions in biotech infrastructures In several countries, biotechnology has been anointed as one of the key priority areas on which a nation's future overall economic success depends. In order to develop and enhance the critical mass of infrastructure required, countries have announced initiatives specifically focused on their domestic biotech sectors in amounts denominated in billions of dollars. Specifically, these amounts are directed at research programs, construction of facilities and related equipment, seed capital funds, promotion of technology transfer and  commercialization operations, regional clustering programs and related science and technology investments. Significant attention is being paid to ensure that invested funds are allocated in such a way as to promote R&D efforts related to specific products as well as enabling platform technologies and processes. Collaboration, networks and clusters Collaboration and the effective sharing of knowledge are key attributes of the biotechnology industry. The highly networked character of current activity coupled with the increased capability offered by information technology creates an ideal environment for a division of labor that spans worldwide to those researchers and facilities who best fit the needs of an individual project or program. Collaborations take on many different forms and range from the traditional multi-party efforts, to virtual networks of computer technologies linked together, to universities establishing joint venture research facilities, to university-industry partnerships, to exchange programs and sister city initiatives. Regardless of form, they are essential due to the complexity, information technology requirements and geographic dispersion of expertise. While technology and communications have allowed for truly global collaborations to take place, the more traditional networking platform based on physical proximityâ€”clusteringâ€”remains a key component of the development of biotechnology activity. The universe of these clusters is growing, with new areas approaching critical mass in several locales outside of the US, mostly centered in Europe. Structural changes Many of the countries are undergoing significant reforms in regulatory and structural areas that, heretofore, have acted as barriers to advanced development in their domestic biotech sectors. Recent legislative and policy changes in this area include the ability for researchers and innovators to retain some level of ownership in the intellectual property they create as well as allowing these same researchers to form and retain equity stakes in commercial endeavors deriving from their discoveries/innovations. Additional reforms facilitate university-industry collaborations and for-profit joint ventures. Further work needs to be done. While legally these activities are now permitted, a significant challenge remains in overcoming the traditional, cultural aspects of the academic and research communities that have long acted in a manner where research and commercialization are mutually exclusive endeavors. In the area of intellectual property rights, Europe is still trying to harmonize its patents system and in China, where intellectual property protection is provided for within the WTO framework, significant emphasis needs to be given to enforcement. Upstarts and laggards Outside of the US, several countries have developed a significant biotech presence within their national economies. Countries such as the United Kingdom, France, Sweden and even Germany have focused initiatives in place along with strong government financial support and rich research traditions. While these countries have historically occupied the leading positions in international biotech, several countries have made surprising moves to get global attention. In the cases of Brazil and China, each country is home to institutions that played significant roles in mapping and publishing a draft sequence of a genome (Brazilian entities worked on sequencing the genome of a citrus canker bacteria and China worked on a rice genome). Singapore is making headlines via the billions of dollars the government is offering to build its domestic infrastructure and position the country as the biotech hub of the Asia Pacific market. Ireland is investing over $500 million in biotech-specific research, infrastructure and programs throughout its university system. While these are examples of countries emerging on to the biotech scene, there are others who are doing relatively little or lack any kind of critical mass in institutional biotech capacity. At the same time Singapore is spending billions on biotech-related programs, the government of Hong Kong has only invested about $100 million in the past five years with recent initiatives amounting to little more than studies of the sector. US Biotech Clusters International Biotech Clusters San Francisco Bay area Brussels (Belgium) San Diego Montreal (Canada) Research Triangle, NC Toronto (Canada) Boston Paris (France) Los Angeles Strasbourg (France) Seattle Munich (Germany) New York/New Jersey metro area Dublin (Ireland) Washington DC metro area Stockholm (Sweden) Medicon Valley (Sweden/Denmark) Cambridge (England) Oxford (England) Edinburgh (Scotland) Hot topics and issues Almost every activity going on today with respect to biotechnology is in some way related to genomics and related fields (e.g. proteomics, gene therapy). Several genomes have now been successfully mapped including those of the human being, a mouse, several types of bacteria, the mosquito responsible for spreading malaria in sub-Saharan Africa, the puffer fish and several plants. With this newfound information, novel therapeutic and diagnostic breakthroughs are emerging and almost every country involved with biotech has some level of research and infrastructure dedicated to the genomics field. The study of genomics is probably the premier example of the convergence between the biotech and infotech worlds as massive computing and processing power is required in the DNA sequencing process. Not surprisingly, much of the efforts in the global biotechnology community are focused on treating, detecting and preventing human disease. Top research areas include cancer, AIDS, neurological disorders, heart disease and diabetes. While the human disease and genomics areas of biotechnology get considerable headlines, it is surprising to many how advanced and how common, the field of agricultural biotech has become. Transgenic crops, resistant to environmental stresses such as weather and insects, have now existed for more than a decade. In fact, significant cropland in the US is farmed utilizing genetically engineered/modified plants, fertilizers and seeds. The widespread production and subsequent exporting of these crops has caused concern, particularly in Europe, regarding the safety of the food supply and long term ramifications of consuming genetically altered food products. Another area of controversy and public debate surrounds the use of embryonic stem cells. Currently, political, religious, and bioethics groups are trying to control what they see as harmful exploitation of stem cells which hold significant promise with respect to regenerative therapies and tissue engineering. The US President Bush recently announced limitations on stem cell research programs with only 78 stem cell lines worldwide meeting eligibility criteria for the US federal funding. Of those 78 lines, 51 were either developed by foreign institutions and/or foreign institutions retain the intellectual property rights associated with the lines. Another area receiving significant attention from the international biotech community is the utilization and development of nanotechnology. Several applications are the focus of substantial research including drug delivery and diagnostic technologies. Beginning of the biotech age There is no question that nations and people around the world believe the biotechnology age is upon them. The great potential that life sciences breakthroughs promise is close enough and/or seemingly real enough for vast programs with billion dollar budgets to be put in place. While some countries such as the UK, France, Canada, Sweden and Germany enjoy financial resources and existing infrastructure that allow for broad-based strategies, others such as Brazil must find creative funding sources and make decisions about investing in technology vs. bricks and mortar. Approaches vary as well. Ireland's biotechnology program is focused, in large part, on investing in the country's university research programs and infrastructure. New Zealand is relying more on developing niches in areas of strength such as agriculture, livestock and dairy. Research themes also illustrate differences in approaches. While Asian R&D looks for innovative uses of traditional medicines and studies the genome of the critical element in its food supplyâ€”rice, a large amount of European effort is targeted at development of biotechnology platforms as well as human therapeutics. While the efforts being put forth are large in scale and underscore a legitimate commitment to the biotech sector, most national initiatives have been in place for less than five years with research programs only just beginning and facilities still under construction. Regulatory, structural and labor issues still exist in many locales that serve to impede the entrepreneurial and technology transfer efforts so crucial in bringing scientific research into the commercial marketplace. While headlines are made in announcing new national/regional biotech strategies, there is little comment (exceptions include Scotland and Canada) on performance measurement or the definition of success. The world is still in the early days of the biotechnology revolution. The increasing size of biotech companies, the breadth and depth of current research efforts and the tremendous advances made in the field of genomics serve to tantalize and intrigue countries around the globe as they rush to gain a foothold and distinguish themselves in some manner. In examining these countries' approaches, one may not yet be able to judge results but one can now ask the questions which, when answered over the course of the next decade, may ultimately reveal the strategies and tactics required for successful national initiatives aimed at science's cutting edge. Can the United Kingdom retain its leading position in the face of intense competition from the likes of Germany and France? Will Sweden, Australia and Canada be able to leverage their ample biotech resources to occupy sustainable global leadership positions? Will Ireland's universities, now receiving hundreds of million of dollars, be able to produce scientific breakthroughs or will the country become simply a European manufacturing base? Can Singapore win its way (via enormous state funding) to a leadership position within the Asia/Pacific region? Will Belgium or Scotland rise to the top ranks of European biotechnology locales? Can the biotechnology sectors in China and Israel thrive in the midst of significant political issues? Can Brazil's research communities sustain itself within an uncertain macroeconomic climate? Will Germany's focus on developing biotech cluster regions within its borders serve as the key component to its ultimate success? Can New Zealand become a leader in niche areas? Does Hong Kong have a role to play? Will Japan's national economic situation holdback its biotech aspirations? When will patent harmonization be finally achieved? Can the EU's regional efforts work in parallel with individual European countries' biotech R&D programs? How will other countries react to life science developments in the United States? These questions and many others currently linger. It is now up to the scientists, financiers and entrepreneurs of the world to take advantage of the largesse being offered to them from policy makers and state budgets and turn potential into reality. (Extracts from the "World of Biotechnology", an international survey of biotechnology strategies, initiatives and institutional capacity, prepared by New Economy Strategies, Washington DC). The full report can be ordered from 1150,17th St. NW Suite 500 Washington, DC 20036 or info@new-econ.com ]]> <![CDATA[World to become "bio safe" from September 11]]> https://biospectrumindia.com/news/95/7092/world-to-become-bio-safe-from-september-11.html https://biospectrumindia.com/news/95/7092/world-to-become-bio-safe-from-september-11.html Mon, 11 Aug 2003 20:39:00 +0530 Thanks to the power and reach of the televison, print and internet-based media systems, most of the world's population will remember the date September 11 because of the terrorist attacks on the World Trade Center in New York on that day in 2001 which killed over 3,000 people. Come September 11, 2003, two years after that event, the world may have that date to remember for another important happening. It will be the day when the first international treaty that will regulate the transboundary movement of all genetically modified organisms. The journey to make the world safe from accidental release of Living Modified Organisms (LMOs) began on January 29, 2000. It has taken the first step to become a reality on June 13, 2003, when a representative of the tiny island republic of Palau deposited a ratified copy of the Cartagena Protocol on Biosafety with the United Nations. As per the provisions of the convention, the treaty will come into effect on September 11, exactly 90 days after the 50th member country ratified the protocol. While India has ratified the Protocol, countries like the US, UK and Japan have yet to do so. The contours of the treaty was evident when the countries that were party to the UN's Convention on Biological Diversity adopted a supplementary agreement to the Convention known as the Cartagena Protocol on Biosafety on January 29, 2000. The Protocol sought to protect biological diversity from potential risks that may be posed by LMOs resulting from modern biotechnology. The full name of the Protocol is the Cartagena Protocol on Biosafety to the Convention on Biological Diversity. Cartagena is city in Colombia where the Protocol was originally scheduled to be concluded and adopted in February 1999. However, due to a number of outstanding issues, the Protocol was finalized and adopted a year later on 29 January 2000 in Montreal, Canada. The Protocol has established an Advance Informed Agreement (AIA) procedure for ensuring that countries are provided with prior written notification and information necessary to make informed decisions before agreeing to the first import of LMOs that are to be intentionally introduced into the environment. What happens to LMOs from September 11 A number of provisions of the Protocol will take effect from September 11, 2003:These are: Countries shipping LMOs for intentional introduction into the environment will have to give prior notification to the importing country that is a party to the Protocol, under what is known as the advance informed agreement (AIA) procedure. They should also provide sufficient information for the first shipment to enable them to make informed decisions. These shipments will have to be identified in accompanying documentation as LMOs with specification of the LMO identity and characteristics and with a declaration that "the movement is in conformity with the requirements of the Protocol". Likewise, shipments of LMO commodities intended for direct use for food, feed or processing will have to be identified in accompanying documentation as "may contain" LMOs and as "not intended for intentional introduction into the environment". Parties will be required to use the Biosafety Clearing-House (BCH) to fulfill a number of obligations. Specific information that must be made available through the BCH includes: national biosafety laws; risk assessment summaries; and final decisions by importing Parties with supporting reasons. The pilot phase of the BCH, which is largely Internet-based, has been developed by the Secretariat of the Convention and is available at www.biodiv.org/biosafety Any Party that approves for domestic use and marketing LMOs intended for direct use as food, feed or processing that may be exported will be required to communicate this decision and details about the LMO to the world community via the BCH. Importing Parties must make a decision on the import of LMOs for intentional release into the environment on the basis of a scientifically-sound risk assessment and communicate the decision to the notifier and the BCH within a period not exceeding 270 days. In cases where scientific certainty is lacking due to insufficient relevant scientific information and knowledge with regard to the potential adverse effects of an LMO on the conservation and sustainable use of biological diversity in the Party of import, Parties may take a decision in order to avoid or minimize such potential adverse effects. Parties will have an obligation to inform affected States and take other appropriate action if they discover an unintentional movement of LMOs across borders. If an illegal shipment of LMOs occurs, the affected Party may request the Party of origin of the shipment to repatriate or destroy the LMO at its own expense. Parties to the Protocol will cooperate to help developing countries build human resources and institutions to make informed decisions about LMOs. What are LMO products? LMOs form the basis of a range of products and agricultural commodities. Processed products containing dead modified organisms or non-living GMO components include certain vaccines; drugs; food additives; and many processed, canned and preserved foods. They can also include corn and soybean derivatives used in many foods and nonfoods, cornstarch used for cardboard and adhesives, fuel ethanol for gasoline, vitamins, vaccines and pharmaceuticals, and yeast-based foods such as beer and bread.   The Protocol makes reference to the precautionary approach contained in Principle 15 of the Rio Declaration on Environment and Development. The Protocol also establishes a Biosafety Clearing-House(BCH) to facilitate the exchange of information and experiences on LMOs and to assist countries in the implementation of the Protocol. The Protocol was adopted by more than 130 countries on 29 January 2000 in Montreal, Canada. During the time it was open for signature, from May 15, 2000 to June 4, 2001, it received 103 signatures. The Protocol aims to contribute to the safe transfer, handling and use of LMOs that may have adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health and specifically focusing on transboundary movements. Experts said from September 11, it will become legally binding in the international legal system and in the legal systems of countries that have given consent to be bound by it; and henceforth member countries must comply with, and implement, all the provisions of the Protocol. The Cartagena Protocol on Biosafety is the only international instrument that deals exclusively with LMOs. Two other international environment related agreements such as the International Plant Protection Convention (IPPC) and the Codex Alimentarius Commission covers various safety aspects of LMOs along with several other issues. The Protocol deals with transboundary movement of LMOs that may have adverse effects on biodiversity, taking also into account human health. It does not, however, cover non-living products derived from LMOs, such as cooking oil from Genetically Modified (GM) corn or ketchup from GM tomatoes. N Suresh Biosafety conscious countries Africa Botswana, Cameroon, Djibouti, Ghana, Kenya, Lesotho, Liberia, Mali, Mauritius, Mozambique, Tanzania, Tunisia and Uganda. Asia & Pacific Bhutan, Fiji, India, Maldives, Marshall Islands, Nauru, Niue, Oman, Palau and Samoa. Central and Eastern Europe Belarus, Bulgaria, Croatia, the Czech Republic, Republic of Moldova, Slovenia and Ukraine. Latin America & Caribbean Barbados, Bolivia, Colombia, Cuba, Ecuador, Mexico, Nicaragua, Panama, Saint Kitts and Nevis, Trinidad and Tobago and Venezuela. Western Europe and Others Group Austria, Denmark, the European Community, France, Luxembourg, Norway, Spain, Sweden, Switzerland and The Netherlands.   An interesting footnote: The first and the 50th states to ratify the Cartagena Protocol on Biosafety are small island developing states: the Republic of Trinidad and Tobago was the first state to ratify the Protocol (1 August 1996). The Republic of Palau became the 50th State to ratify the Protocol on June 13 2003 ]]> <![CDATA[Genome India]]> https://biospectrumindia.com/news/95/1220/genome-india.html https://biospectrumindia.com/news/95/1220/genome-india.html Mon, 11 Aug 2003 20:36:00 +0530 Biotechnology is gaining momentum in India. It is no longer confined to a few government laboratories and companies in a few cities. After Karnataka, Andhra Pradesh and Maharashtra, at least eight states are all set to join the biotech bandwagon. At the top of the heap is Tamil Nadu which has set up a big infrastructure facility, Ticel Park, adjoining its software center Tidel Park. The state is leveraging its strengths in research, engineering and pharmaceuticals to make a mark in biotechnology. Neighbor Kerala is banking on its lead in Ayurveda (a traditional Indian system of medicine) to develop a viable industry in phytopharmaceuticals. Two new states in North India, Chhattisgarh and Uttaranchal have formulated a clear road map to develop the sector based on their rich diversity in biological materials.The western state of Gujarat is placing its bets on biopharma and marine biotechnology. Punjab believes that it can create wonders with bio agriculture on the back of its dominant agriculture sector. This is a heartening development. Primarily the thrust into biotechnology is driven by the urge to be in tune with the modern economy. Knowledge industries are the drivers of growth in the world today and biotechnology is perceived to be the next winner in the global economic sweepstakes. So far so good. But is it a rosy scene out there in the biotech world? According to Ernst & Young, there are some 5,000 biotechnology companies, including 600 publicly traded firm, in two dozen bio active countries. The 600 public companies together showed a net loss of $ 12 billion in 2002. The majority of the private biotech companies too are loss-making ones. However, the good news for the 25-year industry is that more than 50 companies are closer to becoming profitable entities. Most of the entrepreneurs who have jumped onto the biotech bandwagon are aware of the long haul ahead of them. The human genome map and other recent developments in this area have created a lot of hype around the sector. Most industry experts saythat the players should not be taken in by such public attention over these development. The difficult part of the genomics era is ahead: how to make sense out of the data, how to interpret the complex interactions directed by the genes etc. Yet the attention from the policy makers in the bio actives states of India is welcome. As these states build up their biotech sector and compete to attract funds and talent, the awareness will increase tremendously. It will also help to grab the attention of national policy makers. This would then lead to gradual removal of several road blocks in the path of biotechnology. The information technology sector benefited from such attention from the influencers. The road is much more difficult for the biotechnology industry. But the focus is welcome for the long term growth of the sector. ]]> <![CDATA[Building the Golden Triangle]]> https://biospectrumindia.com/news/95/5116/building-the-golden-triangle.html https://biospectrumindia.com/news/95/5116/building-the-golden-triangle.html Mon, 11 Aug 2003 20:20:00 +0530 There is an urgent need to build a strong bond between the traditional medicine, modern medicine and modern science. This realization seems to be dawning on our institutions now. I will begin at home. CSIR happens to be the largest chain of publicly funded industrial R&D institutions in the world. We are a formal system of innovation and we had closed our mind to informal systems of innovation. But we are changing now. I will cite an example to illustrate the point. It concerns our 20-laboratory networked program on discovery of bioactive molecules for their use as drugs and therapeutics. Our research is based on the clues that we get from our vast plant based traditional medicine systems including Ayurveda. For the first time, CSIR forged relationships with Indian traditional systems of medicine, namely Ayurvedic and Siddha systems. I still remember that when CSIR signed the MOU with Arya Vaidyasala in Kottakkal, Professor MS Valiathan, who brought both the partners together, said, "This is a holy place where two rivers are meeting; the river of traditional knowledge and ancient wisdom represented by Arya Vaidyasala and the river of modern knowledge represented by CSIR". The only question I asked myself was that why did it take almost 50 years after the prophetic words by Nehru for these two rivers to merge? I believe this was because we did not heed the advice of Gandhiji and we "walled our houses on all sides and stuffed our windows". These windows are now opening up. CSIR's program includes the identification of target therapeutic areas, selection of extracts, discovering of active fractions, molecular description of active fractions, optimization through mixing of fractions from various extracts, understanding the mechanism of action, toxicology studies, clinical trials and discovery of entirely new herbal products which are efficacious, safe and are reasonably consistent in molecular concentrations. Currently, under CSIR's New Millennium Indian Technology Leadership Initiative (NMITLI) program, several scientists have been working on establishing pharmacoepidemiological evidence-base to Ayurvedic medicines, practice and development of standardized herbal formulations. Randomized controlled clinical trails for rheumatoid and osteoarthritis, hepatoprotectives, diabetes, hypolipedmic agents, asthma, Parkinson's disease and many other disorders have reasonably established clinical efficacy. A review of some of the exemplary evidence-based researches and approaches has also been made. It is clear that we must increase our presence internationally through well-researched publications related to quality, safety and efficacy of Ayurvedic medicines in international peer-reviewed journals. The Ayurvedic, pharmaceutical and medical scientists must come together to make this possible. Ayurveda and Intellectual Property Rights There are ways by which modern scientific discoveries are protected through the system of patents. But how do we protect traditional knowledge and products based on it. In particular, the protection of Traditional Medicine (TM) under intellectual property rights (IPRs) raises two types of issues. First, to what extent it is feasible to protect it by using the existing IPR system? Certain aspects of TM may be covered by patents or other IPRs. There have also been many proposals to develop sui generis systems of protection. Such proposals are based on the logic that if innovators in the "formal" system of innovation receive compensation through IPRs, holders of traditional knowledge should be similarly treated. Leads on 20 diseases have been obtained. A product called ASMONâ€”herbal formulationâ€”which acts on Asthma is replacing synthetic drugs today. An anti-ulcer herbal formulation which is showing superior even to the best setting synthetic drugs, is going into clinical trials now. There are many leads that a team of around 500 scientists working in an India Team fashion is exploring. I wish such a program had started 50 years ago! The grant of patents on non-original innovations (particularly those linked to traditional medicines), which are based on what is already a part of the traditional knowledge of the developing world have been causing a great concern to the developing world. It was CSIR that challenged the US patent No. 5,401,5041, which was granted for the wound healing properties of turmeric. This "second Haldi Ghati Ladai", as it has been referred to, has been a path breaking fight for the first time, it asserted the rights of the holders of traditional knowledge from India in international fora. In a landmark judgment, the US Patent Office revoked this patent in 1997, after ascertaining that there was no novelty; the findings by innovators having been known in India for centuries. This case was followed by yet another case of revocation in May 2000. The patent granted to WR Grace Company and the US Department of Agriculture on Neem (EPO patent No. 436257) by European Patent Office was squashed again on the same grounds that its use was known in India. India filed a re-examination request for the patent on Basmati rice lines and grains (US Patent No. 5,663,484) granted by the USPTO and Ricetec Company from Texas has decided to withdraw the specific claims challenged by India and also some additional claims. There is a problem on the grant of such patents linked to the indigenous knowledge of the developing world that needs to be addressed jointly by the developing and the developed world. We need to understand that there is a distinction between the patents that are granted based on modern research and patents which can be categorized as traditional knowledge based patents. A recent study by an Indian expert group examined randomly selected 762 US patents which were granted under A61K35/78 and other IPC classes, having a direct relationship with medicinal plants in terms of their full text. Out of these patents, 374 patents were found to be based on traditional knowledge not that all of them were wrong. The governments in the third world as well as members of public are rightly concerned about the grant of patents for non-original inventions in the traditional knowledge systems of the developing world. At international level there is significant level of support for opposing the grant of patents on non-original inventions. For example, more than a dozen organizations from around the world got together to oppose the EPO Neem patent and the entire process took five years. Such a process of opposition is understandably expensive and time consuming. It is through an Indian initiative that a solution has been found to this problem which has reached an international acceptability now. The Indian government has taken steps to create a Traditional Knowledge Digital Library (TKDL) on traditional medicinal plants and systems which will also lead to a Traditional Knowledge Resource Classification (TKRC). Linking this to internationally accepted International Patent Classification (IPC) System will mean building the bridge between the knowledge contained in an old Sanskrit Shloka and the computer screen of a patent examiner in Washington! This will eliminate the problem of the grant of wrong patents since the Indian rights to that knowledge will be known to the examiner. Hopefully, wrong patents on turmeric, neem, etc., will be the things of the past! Eventually the creation of TKDL could serve a bigger purpose in providing and enhancing its innovation capacity. It could integrate widely scattered and distributed references on the traditional knowledge systems in a retrievable form. It could act as a bridge between the traditional and modern knowledge systems. Availability of this knowledge in a retrievable form from many languages will give a major impetus to modern research in the developing world, as this itself can then get involved in innovative research on adding further value to this traditional knowledge; an example being the development of an allopathic medicine based on a traditional plant based therapeutic. Sustained efforts on the modernization of the traditional knowledge systems of the developing world will create higher awareness at national and international level and will establish a scientific approach that will ensure higher acceptability of these systems by practitioners of modern systems and public at large. The community of Indian research workers contributing to this important task of integrating the ancient with the modern need to always to look for protection of any intellectual property which meets the basis requirements of novelty, usefulness and non obviousness. Can the existing knowledge and products based on them be protected? The answer is 'No'. What preexists, what is in the public domain cannot be protected. Natural products cannot be protected. Further, the preparations that have been used for many years constitute knowledge in the public domain. Therefore, they cannot be patented. However, if new uses are found, a "use" patent can be obtained. (To be continued) RA Mashelkar ]]> <![CDATA[Public Deception]]> https://biospectrumindia.com/news/95/2359/public-deception.html https://biospectrumindia.com/news/95/2359/public-deception.html Mon, 11 Aug 2003 20:13:00 +0530 First the chemical pesticides. Now GM foods. All are getting promoted with hidden facts For fifty years, they went on promoting chemical pesticides. They termed the obnoxious chemicals as "safe" provided these were to be used carefully. They continued to brush aside reports of pesticides poisoning and the resulting environmental contamination. They surely had a job to do and they did it remarkably well. It took three decades for the International Rice Research Institute (IRRI) to realize the gravest mistake of green revolutionâ€”pesticides are unnecessary. But by the time the mistake was realized, pesticides had polluted the environment, poisoned the fertile soils, contaminated the ground water and taken a heavy human toll. It was instead a case of systematic public deception. Knowingly or unknowingly, agricultural scientists were very conveniently used as loudspeakers by the chemical industryâ€”an industry, which has since then moved to life sciences. And these scientists didn't spare any effort to turn down all the traditional wisdom and knowledge in pest control as "sub standard" and "backward". The only way to increase crop productivity, we were told, was to use more chemicals. Not far from where IRRI is located, rice farmers in Central Luzon province in the Philippines had gradually got disenchanted with the indiscriminate use of pesticides. From a peak insecticide use in the mid-1980s, it is now at an historic low. Contrary to what agricultural scientists and the chemical industry had maintained all these years, the decline in insecticides use has been accompanied by an increase in productivity from an average of 2.75 tonnes to 3.25 tonnes per hectare in 2002. It also resulted in savings on an average of up to 1,000 pesos per hectare for these farmers. Equally significant is the scientific courage with which IRRI's director general, Dr Ronald Cantrell has accepted the reality "It shows that the mistakes of the Green Revolutionâ€”where too much emphasis was sometimes put on the use of chemicals for pest controlâ€”have clearly been recognized and corrected," adding, "because of their toxicity, insecticides really should be used by farmers as a last resort, and we are very pleased to see that farmers have realized this for many years, especially here in the Philippines." His colleagues at IRRI are now equally critical of the extent and use of pesticides. Says Gary John, an ecologist, "The simple fact is that, in the rest of Asia, most insecticide use on rice is a waste of the farmers' time and money." But Nobel laureate Norman Borlaug wouldn't agree to that when green revolution technology was being widely applied in Asia. In fact, I remember when Rachel Carlson wrote the path-breaking book The Silent Spring, I happened to interview Dr Borlaug for the Indian Express. The father of green revolution was surely not going to take it lying down. "Rachel Carlson is an evil force," he told me, adding "these are the people who do not want hunger to be eliminated". Ironically, approximately 25 years after Rachel Carlson's book was first published, Dr Borlaug seems to have finally bowed to public opinion. He is now advocating the use of genetic engineering to reduce the use of harmful pesticides! Pesticides were safe as long as the industry's commercial interests needed protection. Since the same industry has now moved to life sciences and has a huge stake in promoting genetically engineered foods and crops, scientists too have jumped onto the more lucrative biotechnology bandwagon. In fact, such is the desperation to promote the commercial interests of the private companies that even plant breedingâ€”which is responsible for the high-yielding crop varieties that ushered in green revolutionâ€”is now being branded as a dangerous technology. At a recent meeting at the John Inn's Institute for Plant Sciences at Norwich (UK), I was shocked to hear a distinguished molecular geneticist castigate plant breeding. I am sure when Nanotechnology finally emerges on the commercial horizon, the same breed of scientists will term genetic engineering as a dangerous technology! Public money is being ruthlessly squandered to provide legitimacy to GM products. "The European Union has spent Rs 325 crore in 15 years to study the impact of GM products. And it has given a clean chit to GM products", screamed a blurb in the last issue of BioSpectrum magazine. Companies in the US are spending Rs 25-30 crore to comply with the regulatory requirements for a single GM product. In China, Argentina, Australia, Canada, Japan and in Europe, already close to some Rs 10,000 crore has been incurred on field testing and regulating these crops. In India, the GM research on nine crops has cost the industry some Rs 60 crore, and the Department of Biotechnology would end up incurring another Rs 20-30 crore for setting up an ineffective regulatory mechanism. The simple question that no one wants to ask is: Why spend so much money on something, which offers no additional advantage? Why is no body interested in the cost-benefit analysis of developing GM crops? After all, as a consumer what do I gain by eating herbicide-tolerant corn or herbicide-tolerant soyabean? Why should I eat these genes for herbicide tolerance or for Bt toxin? Why should I take the risk? And in that case, why should we have these GM products in the first place, which require such phenomenal costs to regulate? After all, these crops do not increase crop yields. Nor do they provide any additional nutrient to the consumer. Pests can be easily taken care of by adopting well-known integrated plant protection measures (like the IRRI is now advocating). Look at the misplaced emphasis. If only the money that has been spent on field testing and regulation was to be diverted to feeding the hungry and malnourished, almost all the 320 million people in India who go to bed hungry could have been well fed. And that would have also helped in getting rid of the mounting food grain surplus of 50 million tonnes that continues to rot under the monsoon rains. If the Rs 325 crore that EU spent on a wasteful exercise of knowing the impact of GM foods, was to be instead given to Nepal, the land locked country would have overcome its acute hunger crisis thereby wiping out Maoism from the mountains of central Himalayas. If the public money being incurred on GM crops research, regulation and promotion and that too in the name of eradicating hunger and malnutrition, were to be diverted to feed the hungry, the Food and Agricultural Organization (FAO) of the United Nations can meet its target of reducing global hunger by half and that too at least 12 years before the internationally accepted deadline of year 2015. That would mean saving the lives of some 24,000 people who die from hunger and related ailments every day. But no, you cannot ask such fundamental questions. After all, didn't former President Bill Clinton say: "Monsanto is the company which will take us into the 21st century." We are being repeatedly told that if 350 million Americans are eating GM food for the past 15 years and there has been no adverse reaction, what more evidence is required to ascertain the safety of GM foods. This is exactly what they said when junk food started emerging as a major food industry in the United States. Ignorant Americans, believing these scientists, began gobbling down the subsidized food and carbonated beverages. Today, 62 percent of America's population is obese, and human allergies have gone up by 70 percent in the past three decades. Not convinced, a US public interest attorney and director of the Alliance for Bio-Integrity, Steven M Druker, filed a lawsuit that forced the US Food and Drug Administration (FDA) to divulge over 44,000 pages of its internal files on GM foods. Accordingly, the FDA's records reveal that its own scientific experts overwhelmingly concluded, "genetic engineering has unique potential to produce unintended and essentially unpredictable new toxins and other harmful substances". They cautioned that a GM food could not be considered safe unless it had undergone rigorous toxicological tests using the whole food. The uniformity of opinion is attested by the FDA official responsible for summarizing the expert input, who reported: "The processes of genetic engineering and traditional breeding are different, and according to the technical experts in the agency, they lead to different risks". (Photocopies of 24 key FDA documents are in a numbered set at www.biointegrity.org) Nevertheless, FDA bureaucrats, who admit they have been operating under an on-going White House directive "to foster" the biotech industry, disregarded their experts' warnings and covered them up. They then declared there is an overwhelming consensus among experts that GM foods are so safe they don't need to be tested, even though they knew their own experts regarded them as uniquely hazardous -- and even though they knew there was not a consensus about safety in the scientific community at large, as evidenced in a letter by the FDA Biotechnology Coordinator. (FDA document #8 at www.biointegrity.org). And to deepen the deception, they claimed they were not aware of any information showing that GM foods differ from others in any meaningful way, says Druker. What more evidence do you need about the dangers of eating GM food? Devinder Sharma. Devinder Sharma is a New Delhi-based food and trade policy analyst. Among his recent works include two books: GATT to WTO: Seeds of Despair and In the Famine Trap. ]]> <![CDATA[India needs a biotechnology commission]]> https://biospectrumindia.com/news/95/2254/india-needs-a-biotechnology-commission.html https://biospectrumindia.com/news/95/2254/india-needs-a-biotechnology-commission.html Mon, 11 Aug 2003 20:09:00 +0530 A biotech commission is needed to genuinely assess the risks of release of a GMO in the country In March 2002, the Genetic Engineering Approval Committee (GEAC) of the Ministry of Environment and Forests, Government of India, approved the commercial marketing of seeds of Mahyco-Monsanto's Bt-cotton carrying an insecticidal gene from Bacillus thuringiensis that was claimed to produce in the plant a product that would kill cotton pests such as bollworm. This was the first approval of the commercial release in the environment of a Genetically Manipulated Organism (GMO) in India, and we witnessed the first commercial plantation of a GMO in India in 2002. However, as was expected by many of us, there has been widespread failure of the above Bt-cotton in India as described, amongst numerous others, the following reports: Probe sought into the failure of first Bt- cotton crop, The Hindu, 16 April 2003 Government to be cautious on Bt-cotton, The New Indian Express, 24 April 2003 Bt-cotton ryots suffer higher losses, says study, The Hindu, 6 June 2003 Bt-crops fail to live upto promise, Deccan Chronicle, 6 June 2003 In the biological trap (the failure of Bt- cotton in Warrangal and adjoining villages), The Hindu, 10 June 2003 Bt-cotton: adopt weight-and-watch policy, The Tribune, 14 July 2003 Not only that, at least in Gujarat farmers are using other varieties (such as Navbharat) or even second (F2) generation so-called Bt-seeds (In Gujarat, Bt cotton seed loses out to illegal Navbharat, The New Indian Express, 25 April 2003). In May 2002, I received a letter from Kapil Shah of the charitable trust, Jatan, in Gujarat, stating, "Different varieties and versions of Bt-seeds are sold in Gujarat at the rate of Rs 70 to Rs 1600 per 450 grams seed pack". He sent me two samples of such seeds. One was "claimed to be F1 and sold openly with a cash memo with brand name Maxi-151". The other one was from their Khadi Institute, for the product of which Kapil Shah stated: "while processing this cotton, the processors found uncommon itching and rash on their body". All the above-mentioned seeds were sent to me for analysis. As no reliable, uncorrupt and technically sound commercial organization exists in the country today for analysis of GMOs, I tried to send the seeds to a well-known organization in the US through a company in India of which I am the Chairman. The seeds were destroyed by the US Customs and never reached the destination. As I have said above, all this was expected for the following three reasons: No professional, objective and reliable procedure exists in the country for assessment of genuine risks underlying the release of a GMO that would safeguard the interests of the country and its farmers and not serve merely the interests of a multinational corporation (MNC) or those linked directly or indirectly to such MNCs. I have stated these risks and the method of their assessment, elsewhere in detail (Economic and Political Weekly, 13 April 2002, pp. 1402-1406; Down to Earth, 15 April 2002, pp. 49-50). There has been so far no requirement for transparency in the operation of whatever procedures exist in the country for approval of the release of a GMO in the environment. Thus, even though the public has a right to know on what basis was the permission granted to Mahyco-Monsanto for commercializing their Bt-cotton, the RCGM (the Review Committee on Genetic Manipulation, of the Department of Biotechnology, Government of India) and the GEAC have never agreed to make public any information in this regard in spite of repeated requests from many responsible individuals and organizations. No penalty exists in the country for not following the laws of the land in regard to the release and monitoring of GMOs (no matter how inadequate these laws may be), as long as such a transgression of law helps the MNCs and, through steps widely known to the Indian public, those who were instrumental in granting the permission for the release of the GMO under a veil of secrecy, presumably because, on stringent scientific grounds, the permission was unwarranted. The entire sequence of events spread over the last many years that eventually led to the clearance by the GEAC of Mahyco-Monsanto's Bt-seeds in March 2002 (and what happened afterwards) is a story of such transgressions of the laws of the land by the DBT and the Ministry of Environment and Forests. How may we ensure that such a fiasco that has occurred with Bt-cotton does not happen again? If the Government of India, the governments of our states and our bureaucracy are seriously interested in using biotechnology for the largest benefit of the largest number of our people, and not merely in serving the interests of the Government-bureacracy-MNC nexus that is widely known to serve only its own interests and not that of the people of the developing and the least-developed countries, they must together set up an independent Biotechnology Commission consisting of members who would satisfy the following criteria:  High professional ability recognized nationally and internationally using stringent criteria  Adequately demonstrated honesty, integrity and courage of a high order  High public credibility of which indisputable evidence exists  Established commitment to the country  Proven qualities of leadership. The Commission should set up, amongst others, a system for clearance of a GMO for release in the environment. This system would first assess (a) the need for such a release; (b) the credentials of the organization that is asking for the release; and (c) the experience with the GMO elsewhere where it may have been released. It would then investigate alternatives such as Integrated Pest Management for cotton. If after this investigation and analysis, the Commission (or the system mentioned above that it sets up) feels that there is an established need for the GMO and no alternative to it, it would state the risks of the proposed release and the methodology of assessment of these risks. If the GMO passes this risk assessment procedure, the system would assess the residual risk which will always be there, against the expected benefit, and permit the release only if the expected benefit exceeds the residual risk. Furthermore, the entire process mentioned above must be transparent, with the public having access to all the relevant information at all stages of assessment. The assessment procedure must, in fact, involve all the stake holders at appropriate stages of the assessment. Lastly, the Commission must clearly state the monitoring protocol for a follow-up after the commercial release of a GMO, as is done in the case of release of new drugs. It is unfortunate that no release of any GMO â€“ perhaps, anywhere in the world, and surely in India â€“ has followed the above procedure. We must remember that, unlike drugs produced through genetic engineering, a GMO once released cannot be recalled. We should not the forget the havoc that has been created in our country by unintended and unmonitored release of water hyacinth and of parthenium (Congress grass). None of these existed in the country before I was married and it is a dreadful thought that our married life has been synchronous with the emergence of these two as the most expensive weeds ever in our history! I would not like our children to face the same situation in future with GMOs. ]]> <![CDATA[Small lab, big science]]> https://biospectrumindia.com/news/95/2810/small-lab-big-science.html https://biospectrumindia.com/news/95/2810/small-lab-big-science.html Mon, 11 Aug 2003 18:54:00 +0530 For instance, there are some complex questions which biologists have been trying answer for decades. And scientists at NCBS have demonstrated successes in studying how proteins fold, how super-families of proteins are organized, how cells move cargo from one place to another, how they signal to each other when they develop normally and in cancers and how the brain reacts to stress and to other less harmful stimuli, informed NCBS director K VijayRaghavan. Success has come fairly quickly to NCBS which started as the biology research center of the Mumbai-based research giant, Tata Institute of Fundamental Research in 1991. It operated out of TIFR's Bangalore campus till five years ago. On July 1, 1998, the laboratory moved to its own facility located inside the University of Agricultural Sciences campus on the Bangalore-Bellary Road. In fact, 1999-2001 changed the face of NCBS with an explosion in developmental activities. During this period, NCBS transformed itself from a small compact " all hands on the deck" kind of organization into a large, complex National Center as conceived by the Planning Commission of India. This period saw expansion on all fronts. Grants administered increased four-fold; funds increased by 300 percent. The center moved from a small set up of 1300 sq.m to a large 20-acre complex with a built up space of 15,000 sq. m. Of course, at the global level, NCBS is still small in size and numbers. NCBS prides itself on the interdisciplinary approach to research with intense interaction between researchers in biological and physical sciences. The four areas of research are: biophysics, biochemistry and bioinformatics; cellular organization and signaling; genetics and development and neurobiology. Inter-disciplinary approach is a key activity at NCBS. Plants are subjected to a number of abiotic stresses such as heat, cold, drought, flooding and salinity and a large number of genes are turned on in response to stress. " We are participating in a project to look for qualitative differences in gene expression on exposure to stress. Using a differential screen, we have identified over a dozen candidate genes, including genes encoding LEA proteins which are known to be involved in stress tolerance," said Dr M K Mathew in the biochemistry, biophysics and bioinformatics division. Scientists are currently sequencing and characterizing the novel genes picked up in this screen. The NCBS team works closely with agriculture scientists in UAS in this work. Gaiti Hasan and MK Mathew " If we can understand the system well enough, we can intervene effectively," said Mathew. The genetics laboratory is one of the few in the world which is working extensively with the Drosophila ( fruit fly) to understand the process of signal transduction. When signals are transmitted beyond a single cell, more complex signal transduction pathways are used. One such pathway is the release of Calcium ions in response to Inositol 1,4,5-trisphosphates ( InsP3) generation in the cell. Dr Gaiti Hasan and colleagues are studying these signal pathways extensively . The bioinformatics division specialized in the computational approach to protein science. NCBS is a hot house for top end research in the world. Nearly 20 scientists besides conducting their own research guide over 140 students with their research work. NCBS also offers an integrated Ph.D program and this course is highly sought after from students around the country. NCBS is yet another addition which is helping Bangalore emerge as the "Science Capital" of the country besides being the "Silicon Valley." N Suresh " We would like industry to support basic research generously" Which are the major thrust areas of activity at NCBS? NCBS Director K VijayRaghavan Research at NCBS addresses questions at the forefront of biology as seen from four perspectives. First, we study how DNA and proteins function at the molecular level and we do this using very inter- disciplinary approaches that range from computer science, experimental physics to spectroscopy. Next we study how cells function in health and disease using the tools of high- resolution microscopy. Third, we study the genetics and development of animals, humans included. And finally, we study how the brain develops and processes information. How do you rate the success of NCBS? Could you give a few examples in which the work is considered to be world class? Success or the lack of it is best left for history to judge. Insider- views of young organizations are likely to be unduly rosy. That said we do feel very excited about what we are doing. And we do feel that we are world class. We have demonstrated successes in studying how proteins fold, how super- families of proteins are organized, how cells move cargo from one place to another, how they signal to each other when they develop normally and in cancers, and how the brain reacts to stress and to other less-harsh stimuli. How is NCBS helping the generation, dissemination and preservation of knowledge in the relevant areas of its mandate, both nationally and globally? We are a small place and intend to remain so. A small place can be effective if it is focused and nimble. We try not to do everything and we try and are excellent in whatever we do. On the other hand, many aspects of modern biology require size and huge resources. We hope that we can balance the contradictors of huge resources and infrastructure on one hand and investigator-driven research on the other. We often try and do this by using our capabilities in collaboration with those of others. Do you think a right balance has to be found between the requirements of cutting edge research for the sake of knowledge generation and applications which could be taken up by the industry in due course? We are driven by our research in basic biology, not by an urge to be of value to industry. But, by doing our job, in basic research, well, we will be valuable to industry, much more so than if we try to be like them. So,yes there is a balance to be found. But that balance is a natural consequence of being open to the world around us while doing our job well. It is not a balance between patents and papers as are often portrayed. What are the expectations of the NCBS community from the biotech industry and funding agencies such as the government in furthering the progress of the biotech sector? We would like industry to support basic research generously. In particular, if industry invests even modestly in ('no- strings- attached') fellowships for talented students and other researchers, this will have a great impact on the biotech industry. Similarly the government does have attractive grants for collaboration with industry. More of these, even small grants, are needed. How do you keep the excitement levels constantly high at NCBS? Most of our academic population is young and will always be so, because students or others mainly populate us on fellowships. The young are excitable, excite others and are excited. We get the best people in the world to visit us. This sets the standards against which we have to perform. All this excitement is therefore not stress- free, but it is the kind of stress that one must have. Could you give a specific project being pursued by NCBS team which has the potential to be a major breakthrough in terms of scientific advancement as well as immediate benefit to the society? I wish I could. We would be rich and famous then. The kinds of things that excite us usually results in a publication, which might excite, when it is published, half a dozen laboratories in the world. None of this is likely to be of any predictable help to society and it will be very wrong to claim possible benefits. But, society benefits greatly by having a place where good science is done. Just as it benefits by a good cultural environment or by art. The tangible economic benefits for society will surely come, but one can never predict when or how or from what kind of research. But the intangible benefits to the soul of the city, state, country and to global science in general do exist and are very important in itself. What are the future plans for expansion and consolidation? Expansion is easy and will result in robustness. But robustness, in academia at least, is the enemy of excellence.We must be excellent and not just survive. How can we be small, and be excellent and live to tell you how? I wish I knew, but knowing the dangers of not being excellent is half the battle won. Our plans are, simply, to be nimble and try to be very good. Bangalore is emerging as the "science capital of India". Are there any gaps, which could help, fill the inter-disciplinary needs for interaction? We need a good, vibrant watering-hole for academics and for industry. This should be located (pardon my impertinence) in the Indian Institute of Science or the National Institute of Advanced Studies (NIAS) in a pleasant part of the campus (a central location, in other words). It should be funded entirely by industry and membership fees should be nominal for academics of all kindsâ€”scientists, social scientists etc. Fees for non- academics should be high, even exorbitantly so. Such a watering holeâ€”open and free for students of courseâ€”will greatly benefit innovation. The person who can start this process and fill this 'void' will be a true hero! Where do you think the biotech industry/segment will be five years now, in terms of capturing public imagination and attention? The biotech industry can only grow in Bangalore and in Indiaâ€” if all other parameters (infrastructure, social tensions etc.) are favorable. The market in India is huge. The global market is huge. Local talent is available. Our academic, government and financial bureaucracy have a great opportunity to reform and move forward. But,one never knows. We have had opportunities before and have managed to snatch defeat from the jaws of victory! ]]> <![CDATA[Unique toxico research lab]]> https://biospectrumindia.com/news/95/3977/unique-toxico-research-lab.html https://biospectrumindia.com/news/95/3977/unique-toxico-research-lab.html Mon, 11 Aug 2003 18:47:00 +0530 Maintaining reasonable health standards is not an easy task, especially in a country like ours with widespread poverty, poor hygiene, low living standards and the sub-tropical climate which helps disease organisms to thrive effortlessly. In such a scenario, the nation has to develop its own techniques to combat its unique problem. As a part of the solution, mainly to guard the health of industrial and agricultural workers, the Industrial Toxicology Research Centre (ITRC), Lucknow, was set up in 1965 by the Council of Scientific and Industrial Research (CSIR). The pristine surroundings of the ITRC campus in the heart of Lucknow provide a visitor instant clues to the high quality research work being done in this premier laboratory. Clean water is an essential component of agricultural operations and in a large number of industrial processes. No wonder ITRC has chosen water as one of its theme and a lot of research work is directed at making this valuable resource as clean as possible. And driving the crusade is Dr YK Gupta, director, ITRC, whose firm belief in the youth and innovative ideas is a major motivating factor to the scientists at the centre. "The basic or primary concern ahead of ITRC is to create a new knowledge base of health and chemicals. It is a unique and important scientific resource in toxicology safety research and testing. In this regard innovative ideas are very much required for research," said Gupta. The lab has developed a number of devices and techniques to analyze the toxicity of air and water. The scientific expertise of ITRC provides facilities for toxicological research, environmental and health risk assessment and analysis and toxicity testing services conforming to Good Laboratory Practices using national and international guidelines employing the latest test systems, biomarkers, analytical instruments and mathematical models. About the strengths of the lab, Seth said, "At ITRC, we have a large knowledge base and analytical as well as experimental skills as our big strength. This has been built over the last three decades in the areas of health risk assessment, preventive toxicology, predictive toxicology, environmental toxicology, inhalation toxicology and analytical toxicology. The centre is also equipped with facilities in the field of molecular toxicology and regulatory toxicology. These can be called as one of the most sophisticated infrastructure available in the country." Elaborating the laboratory's strengths, Dr Kailash Khulbe, scientist, Research Planning and Business Development (RPBD), ITRC, said, "We also organize public awareness camps and outreach programs to spread awareness among the masses. The information is put to practical use by regulators, policy makers and other scientists in industry, government and academies. In this way ITRC is acting as a bridge between all these sections of the society." Khulbe added, "The laboratory undertakes cutting edge scientific research to assess the impact of industrial and environmental chemicals on human health and ecosystem and also instituting programs for early identification and prediction of health disorders due to exposure to chemicals. This data helps in arriving at sound decisions for regulation of chemicals and introduction of safe products." Technologies available with ITRC Water Analysis Kit: A portable analysis kit for carrying out chemical and bacteriological tests has been developed, to determine the quality of water from public health point of view. The kit permits physicochemical and bacteriological tests to ensure safety of drinking water. The kit has been patented and the know how transferred to Jain Scientific Glass Works, Ambala Cantt; Gopi & Gopi Scientific Agencies, Kakinada and Mathbin Scientifics, New Delhi. Colour Detection Strip (CD-Strip): The colour detection strip is used for the detection of butter yellow, a fat soluble cheap dye used some times to colour mustard oil. It is simple, easy and very fast on the spot test. A drop of test oil is placed on a small piece of chemically coated strip and change in the colour of the spot is observed. The maximum detection limit of this test strip is 0.001percent (10 ppm). The device has been patented and the know how transferred to Nelofe, Lucknow for its commercialization. Bact-O-Kill: An electronic device has also been developed for disinfections of water to make it potable. Mobile Laboratory Van: A mobile water-testing laboratory has been developed for physicochemical and bacteriological assessment of potable water in villages and remote areas. ITRC has made some significant contributions to the industry like exploring the mechanisms by which pesticides, heavy metals, monomers, plasticizers and other plastic additives, solvents, food colors and dye intermediates act and elicit deleterious effects on human health. The centre has also developed a method for early diagnosis of manganese poisoning. A peripheral model for monitoring the neurological disorders caused by neurotoxic substances and test kits for the detection of toxic food adulterants have been designed. The Drinking Water Mission, Ganga Action Plan, Technology Mission on Edible Oils and Pulses, Global Climatic Change Program and the All India co-ordinated programs on food colors, pesticides and metal exposure assessment are also some of the major programs in which the ITRC has played a key role. ITRC scientists have isolated microorganisms, which have the potential to degrade pesticides such as DDT, Endosulfan and lindane in the sites contaminated with them. "The institute has undertaken some challenging assignment on testing of newer products reaching the markets including bio-engineered products. Ability of some chelating agents in neutralizing the toxicity due to metals and immunomodulators in case of solvents and monomers in animal models have been demonstrated at the centre. Vitamin B complex supplementation has been found to diminish susceptibility to lead and cadmium intoxication" informed Seth. The laboratory signed a MoU with National Institute of Criminology and Forensic Science (NICFS) to provide training in toxicology. Also ITRC has been assessed and accredited in accordance with the standards of ISO/IEC 17025 in the field of chemical testing by National Accreditation Board for testing and calibration Laboratories (NABL) of DST. Faiz Askari "Innovative idea needs to be motivated" Sitting with the ITRC director is a treat for any curious person. Because Gupta loves to answer all the curious questions, however simple it may be, without any trace of irritation. Soft spoken, innovation driven, Dr YK Gupta shared with BioSpectrum the highlights of the institution. Excerpts: Which are the major thrust areas at ITRC? The institute has a multidisciplinary team in the field of molecular biology, biochemistry, pharmacology, pathology, chemistry, zoology, microbiology and environmental sciences. In addition to this, new infrastructure facilities include Toxicology Information Centre, Bioinformatics Centre and other high end IT applications. An independent Research Planning and Business Development (RPBD) section for better coordination and liaison with industries has also been established at the centre. A newly developed Animal Facility as per GLP standards is almost ready. This will include breeding facility for different species of rodents, both inbred and transgenic strains and all types of animal exposure facilities. The major R&D programs of ITRC are organized in the following six areas: health risk assessment, preventive toxicology, predictive toxicology, environmental toxicology, inhalation toxicology and analytical toxicology. We are also emphasizing on toxicogenomics, genotoxicity assessment of different chemicals/pollutants and genetically modified foods. What are the new projects in the ITRC pipeline? Many technologies are in the pipeline. Some of them include: Arsenic analyzer: Arsenic contamination of ground water which results in serious disorders including fatalities is a global problem and detection of arsenic in ppb (parts per billion) level is a tedious job. ITRC has developed a field deployable low cost kit which can detect arsenic up to 10 ppb in water. The technology has already been patented and transferred to a major player in the field of analytical instrumentation in India, ELICO Ltd, Hyderabad. Lead and copper sensor: A sensitive reliable and cost effective voltametric technique for the simultaneous estimation of lead and copper in blood and natural water samples has been developed. From the point of view of safeguarding the environment, what are the hurdles? The biggest hindrance in safeguarding our environment is the lack of awareness about the science. Misconceptions about science are the main factors which are building a gap between society and the science. To bridge this gap, it is needed to have trust on innovative science and its applications. Catering to this need of the society, we are conducting health surveys. Spreading education and awareness about the usage of chemicals in industries is also one of our focus areas. Where does India stand in toxicology research at the global level? "All substances are poisons. There is none which is not a poison. The right dose differentiates a poison from a remedy" said Paracelsus (1493-1541). Accordingly the toxicological estimation of all the intruders should be done very carefully. Therefore, the importance to toxicology has been increasing day by day and our centre is a renowned institution in this field. It is well-recognized worldwide and it is evident from its significant achievements and the presence of an exciting work force in the institute. ITRC is the only lab of its kind in South East Asia. In this way we are heading towards meeting the new challenges in the era of genomics. But, a country like India definitely needs to grow in this area. Today, the main concern ahead of us is to spread the knowledge and work on innovative ideas to make ourselves leaders at the global level. What is the future of toxicology in an area like genetics? There are different cytogenetic techniques in the field of genetic toxicology to evaluate the genotoxic potential of different chemicals. It is a fast growing field. From this, the DNA damage could be estimated resulting from life style, occupational and environmental exposure. ITRC is oriented towards understanding the mechanism of toxicity at the molecular level. We are also working on the development of "biomarker" for assessment of human exposure to chemicals for predicting the consequences of low-level chemical exposure on health and environment and identify populations susceptible to chemicals. Molecular biology and biotechnology approaches are being used to monitor the toxic chemicals and for bioremediation of toxicants. To commercialize any technology, what are the basic requirements and how is ITRC meeting them? Commercialization of any technology is vital for its success. As soon as we develop a technology we publicize it through seminars and workshops about that particular product. The know-how is then transferred to a prospective manufacturer on terms and conditions mutually agreed upon. What is the future of biotech in Uttar Pradesh? The state of Uttar Pradesh has multidisciplinary expertise covering all branches of modern biology and biotechnology, besides being a vital part of the granary of the country. It is also endowed with enormous biological resources and a rich biodiversity in the form of plants, animals and microbes. The availability of highly skilled human resources in various research institutions, medical colleges and agricultural universities in Lucknow and surrounding regions of Uttar Pradesh is a strong driving force for promotion of technology and application in the state. Uttar Pradesh has good future in biotechnology as the state government has taken initiatives to invite the biotech industry to Lucknow. ]]> <![CDATA[Bio Event]]> https://biospectrumindia.com/news/95/2524/bio-event.html https://biospectrumindia.com/news/95/2524/bio-event.html Mon, 11 Aug 2003 18:43:00 +0530 Pharmacovigilance Meeting Pharmacovigilance Meeting An international meeting on "Pharmacovigilanceâ€”Promoting Drug Safety Through Collaboration" will be held on 5-6 December in Mumbai. Organized by the Drugs Controller General of India, this meeting will be on the risks and benefits of medicines. The meeting will be preceded by a workshop on "Pharmacovigilance." For more details, contact: dcpkem@vsnl.com Drug Discovery Technologyâ„¢ World Congress IBC Life Sciences is organizing the 8th Annual Drug Discovery Technologyâ„¢ World Congress from 10 -15 August 2003 at The Hynes Convention Center in Boston, MA. Conference sessions will address new technologies, scientific advances, business strategies and informatics solutions which help the drug discovery process. The Drug Discovery Technologyâ„¢ World Congress is meant for drug discovery researchers and business executives to evaluate and understand the latest scientific, business and informatics advances in drug discovery research. For more information, contact: emassa@ibcusa.com BIO Venture Forum West 2003 The Biotechnology Industry Organization (BIO) is hosting the third annual BIO Venture Forum on 14-16 October at the Palace Hotel in San Francisco. It will showcase the richest representation of the West Coast's most influential and prominent biotechnology product and platform companies. The conference will also feature a track of later-stage companies nearing a public offering and public companies. For more information, contact: jrapp@bio.org Pharma Expo 2003 Confederation of Indian Industry (CII) is organizing its first flagship international exhibition and conference on the pharmaceutical industryâ€”Pharma Expo 2003â€”at Mumbai. The exhibition, to be held from 14 -17 November 2003, will showcase the latest plant and equipment for pharma production, packaging machinery, analytical instruments and biotechnology. For more details, contact: Tel: 0 22 2493 1790 / 2493 0565 darryl.dasilva@ciionline.org. Biotech India International 2003 CIDEX Trade Fairs Pvt. Ltd and Biotech Consortium India Ltd (BCIL) are jointly organizing Biotech India international 2003 in Hyderabad. This will be held from 24 to 27 September 2003. The exhibition site is the Hyderabad Trade Exhibition Center (HITEX), near Hitec City. The exhibition covers different sectors such as bioprocess equipment, biotech products and services, R&D, bioinformatics, chemicals & reagents and support services. The international exhibition and conference on pharmaceutical industry, fine chemicals and servicesâ€”Pharma India 2003â€”will be held simultaneously. For more details, contact: Tel: 011 26971056/66 thakurJ@cidex-tradefairs.com InfraMedica Meet An international exhibition on the latest technologies in medical and surgical equipment, InfraMedica will be held in Pragati Maidan, New Delhi from August 28-30. A concurrent business seminar is also scheduled to be held with the event. Another highlight of the event, organized by FriendzEvents & Promotions will be a special pavilion on the Indian System of Medicine . ]]> <![CDATA[Distribution of 2002 cross-border alliances: biotech-biotech and biotech-big pharma]]> https://biospectrumindia.com/news/95/1845/distribution-of-2002-cross-border-alliances-biotech-biotech-and-biotech-big-pharma.html https://biospectrumindia.com/news/95/1845/distribution-of-2002-cross-border-alliances-biotech-biotech-and-biotech-big-pharma.html Mon, 11 Aug 2003 18:20:00 +0530 Source: Ernst & Young, BioWorld Distribution reflects 206 cross-border alliances ]]> <![CDATA[Industry wave]]> https://biospectrumindia.com/news/95/7348/industry-wave.html https://biospectrumindia.com/news/95/7348/industry-wave.html Mon, 11 Aug 2003 12:35:00 +0530 Biotechnology is a field that has opened up new vistas for job seekers in recent years. As the industry expands in terms of activities and numbers, there is a long line of hopefuls waiting to enter this sunrise segment. Many students pursuing their engineering courses in various disciplines are planning to opt for biotechnology. It is important that they know what specific skills would be required by the growing biotech industry. The scientific and technical talent in engineering , process development, manufacturing and rapidly developing clinical research capabilities in India is recognized all over the world now. At the macro level this is fine. But companies would be very happy to get people with the right skills who could start straightaway with minimal internal training. And as many of the leading biotech companies pursue expansion, a Big Bang effect in recruitment is expected soon "Success for Indian biotechnology will largely depend on creating the lowest cost base for innovation, a strategy pursued by other nations including China. India needs to differentiate itself through high-value innovation. It is imperative to evolve fiscal and regulatory policies that alleviate capital intensive research and manufacturing, long gestation timelines for product commercialization and investments in patenting and technology licensing," said Kiran Mazumdar Shaw, chairman and managing director of Biocon India Ltd. This big bang effect in biotech industry is not a sudden outcome. More biotech-related jobs are available now than ever before, thanks to recent industry dynamics. With many of the biotech pieces falling into place now, this sector is all set to change the dynamics of material sciences, agriculture and medicine. Molecular chemistry, organic chemistry, botany and biology have been the building blocks for biotech companies in the past. Now computer science is nearly as important as other segments. Biotech companies are relying on computer programmers more than ever before. "The science of biotechnology together with the peripherals of this sectors will sprout numerous job opportunities. The opportunities include business development in contract research in the various segments of biotech, financial management of biotechnology, legal issues related to intellectual property rights , ethical issues and intellectual property rights," said Villoo Morawala-Patell, founder and CEO, Avesthagen, Bangalore. What do companies look for specifically while recruiting people? Said S Sowmyanarayan, assistant manager, Strand Genomics, "Requirement from an individual is the ability to contribute either in life sciences or IT when working in a team comprising of professionals from both fields. The basic qualifications we look for are a master's degree or a doctorate( Ph.D). There are quite a few people getting trained in bioinformatics today. The posts offered will depend on their qualification, experience, aptitude and ability. The salaries are benchmarked against industry standards and would be comparable with any other industry including IT." "We are employing around 60 people in Avesthagen and get a very raw set fresh from the academia. They need rigorous training to be reshaped to fit the industrial bill. An international scientific advisory committee is with us, which pulls us up every year on this score. Right now we have with us Dr David Frisch from the US who is training our personnel on genome sequencing and studies. Preferences are given to post-graduates and doctoral degree holders," observed Morawala-Patell of Avesthagen. Also, companies would like even scientists to have a better understanding of the business processes and environment. Of course, interpersonal skills, the ability and willingness to learn, to mould, to change are other things that employers look for in potential candidates. Companies feel that educational institutions could provide the industry with candidates with more ready-to-use skill sets. The industry too would like to work with the academia to make this happen. "For best-trained manpower, the institutes and the industry need to work together in developing better talent in this sector. The sector is growing at an impressive rate and companies, which understand the 'real issues' of the industry will only survive in the long run. Working with such companies will result in overall development for professionals in this sector." said Strand's Sowmyanarayan. Added Ocimum Biosolutions CEO Anuradha Acharya, "We need good Masters and PhD level programs in biotech manufacturing. It could be in conjunction with an existing department like chemical engineering and biotech department. More training is needed for the people coming out fresh from colleges." Sartorius AG, a German based company has a lot of expectations from its Indian wing. Especially so because the German major is placing its bets on the Indian talent to provide it great results in bio-manufacturing. "The most important asset of any company today is brainpower. Active knowledge management therefore is one of our primary tasks. The challenge is to provide knowledge at the right time and place. The creative and intellectual think tank in India can and shall drive growth for Sartorious in Asia and the Sartorius Group as a whole." This are the words of Prof. Dr Utz Claassen, Group CEO and chairman of the executive board, Sartorius AG. There are companies like Ranbaxy Laboratories and Wockhardt, which were primarily pharma companies, now investing heavily into biotech. Their requirements are slightly different from the pureplay biotech players. "There will be a demand for well-trained people in the field and the hiring is expected to go up significantly in next few years. But as such now the manpower available in this field is not adequately trained. We will not take a chance, because we cannot afford to make any mistakes as we are dealing with drugs and possibly recombinant drugs. We take people from IITs and other regional colleges of excellence. We plan to employ about 20 to start off and then progress slowly. Also the manpower available in this sector is not adequately trained. We need to develop programs to increase innovation amongst our students and there are only a handful of institutes to encourage that. The truth is that most companies are looking for people who can do the job efficiently and not just a person with a degree. However, a degree from a reputed institute like IIT helps get across the resume filtering round." said Dr Kulvinder Singh Saini, director- biotechnology and bioinformatics, Ranbaxy. He too recommends that students should be provided more hands-on training in addition to the theoretical knowledge. As of now the thesis projects for MSc and PhD are only "academic" in nature, with little consideration about the industry expectations." According to Habil Khorakiwala, chairman of Wockhardt, "In our continuing thrust of developing leaders within a leading organization, we have initiated a unique management program with the renowned London College of Management. This three-year program makes it possible for our field personnel to acquire a MBA degree specializing in sales and marketing from the college. While the program brings the latest in the field of sales, marketing and strategic planning to our sales force, it also enables them learn from the best in the industry. Wockhardt also offers an attractive scholarship linked to the work performance of the personnel. This is a major step in creating our own virtual university - the Wockhardt Institute of Learning." There is a strong demand for individuals with degrees in the life sciences and computer sciences and multiple years of programming and database development experience. Typical combinations include a PhD in molecular biology, cell biology, or biochemistry and biosciences and in computer sciences. Life science PhDs, largely self-taught in key computer skills with industry experience have good opportunities. People who emerge from the few doctoral programs in bioinformatics also will be "incredibly marketable", especially those with industry experience. Many Indian companies have introduced separate packages for their biotech employees. They are looking for people who have skills in  Gene manipulation of microbes and animal cells.  Capacity in downstream processing and isolation methods.  Skills in extraction and isolation of plants and animals products.  Competence in recombinant DNA technology of plants and animals. Biocon, as a leading player in biotechnological solutions, is seeking capable and focused individuals who can contribute significantly to its growth. It is on the look out for professionals in manufacturing, quality assurance, research & development and marketing in the areas of enzymology, microbiology, biochemistry, biochemical engineering and pharmaceutical sciences. Aurigene, a Bangalore based drug discovery company, creates opportunities to enhance knowledge, provide the freedom to make mistakes and take risks in driving the organization towards its goals. Teamwork and multi-tasking across functions form the foundation of their philosophy. Aurigene is looking for the talented individuals who relish teamwork and those who have a passion for drug discovery, high integrity in research as well as daily life, ability to experiment and innovate, keenness for collaborative work, desire to be challenged and respect for individuals. According to VV Raghavan, managing director of Lotus Labs, a Bangalore- based contract research organization, " For the next three years, I think drug discovery and molecular biology will be the hot areas in biotech sector. As far as our company is considered we are into clinical trials and are looking for the students who have completed MPharm, MBBS, MD and MSc(analytical chemistry)." "The catch here is, while the biotech sector is poised for a boom just as the IT sector in the Nineties, it should not be over- hyped. There needs to be a focus on fundamental issues: Are we funding the sector adequately? What are the chances of original R&D and manufacture of biotech products? Are we again going to breed a set of professionals whose career fortune will swell and ebb with any slight change in the trends? Unless our efforts are directed at these fundamental issues, career opportunities are bound to stagnate beyond a point and India will not be able to join the biotech bandwagon," says MG Arun, editor, Pharma Bio World. It is also true that India has a large skilled workforce that can work on research, manufacturing and sales of biological products, as well as use its strengths in IT to analyse data (bioinformatics). Once there is more clarity on the legal aspects of clinical trials, even that is a big opportunity. There is absolutely no doubt that biotechnology is going to be a major determining force in the discovery of new medicines and improved agricultural productivity. With developments like the sequencing of the human genome, it is not far off when we will have medicines that would strike at the root of "hereditary" diseases like diabetes. Biopharmaceuticals are going to play a big role in treatment of diseases in the future. Roby Ajith ]]> <![CDATA[Winning the race]]> https://biospectrumindia.com/news/95/1766/winning-the-race.html https://biospectrumindia.com/news/95/1766/winning-the-race.html Wed, 23 Jul 2003 11:53:00 +0530 In the Knowledge Economy, US is the undisputed leader. So it is no surprise that in biotechnology too, America leads the world. And the rest of the world tries to catch up with the US. Who will be the closest competitor to the US in biotechnology? There are 17 nations vying for the second spot in biotechnology. They are: Australia, Belgium, Brazil, Canada, China, France, Germany, Hong Kong, Ireland, Israel, Japan, Mexico, New Zealand, Singapore, Sweden, Taiwan and the UK. A Washington DC-based consultancy organization, New Economy Strategies, has painstakingly profiled the efforts of these 17 significant biotech clusters in a report "The Scan of International Life Science Clusters and Activities". By now, it is clear that India is not included in this list. But can India join this list? Certainly, yes. It can happen when the biotechnology companies, research institutions, funding agencies and the government work collectively towards this goal. Even in these days of economic liberalization, when the government is trying to get out of various sectors, there is a strong case for it to support biotechnology in a big way. For, this will not be an exception. These 17 countries have been supported heavily by the their governments in a big way. The government efforts in these 17 countries are clearly focused on ensuring that the national agenda concentrates on collaborative research programs, public-private partnerships and support to the commercialization of newly developed technologies. For India too, there are lessons to be learnt from the experiences of the other biotech leaders. The problems faced by the biotechnology sector in India are almost the same as that in other countries. Most of the companies are small, private and unprofitable. Seed funds are not available and complex regulatory processes are hampering innovations. There also exists resistance to the government research centers and academics collaborating with private companies. The Cover Story of this issue has highlighted 10 hurdles in the path of progress of the national biotechnology sector. Some of our enlightened policy makers are aware of these issues. They have been grappling with these for some years now and are trying to cut through them to make it easy for the biotech industry. But more efforts are needed. A well articulated national policy on biotechnology should be the starting point. And reiteration of the national commitment to the sector should help. In 15 years, the government has invested approximately $500 million (Rs 2,500 crore) in the biotech sector. Ireland, a country many times smaller than India in size and economy, plans to invest over $500 million in biotech in the next few years. There is no doubt anywhere in the world that biotech will be a key driver of the economy in the coming years. Let India too join the biotech bandwagon at least as the 18th player without losing any more time and aim to leave all others behind, drawing on every ounce of our national talent. ]]> <![CDATA[The Dragon's biotech thrust]]> https://biospectrumindia.com/news/95/1678/the-dragons-biotech-thrust.html https://biospectrumindia.com/news/95/1678/the-dragons-biotech-thrust.html Mon, 21 Jul 2003 22:13:00 +0530 In recent years, with the emergence of China as an economic giant, its performance in various sectors is monitored closely by entrepreneurs and policy makers in India. In biotechnology too, China is emerging as a key player riding on large-scale investments made by the government since the Eighties. India too started major biotechnology investments around the same time. Where do we stand vis-a-vis China in biotechnology. The second Ernst & Young report, " Beyond Borders: The Global Biotechnology Report 2003"provides an insight into the biotech industry in China. For the report, Ernst &Young asked Yuanhong Robin Ma, president of Clingenix, to discuss the progress of biotechnology development in Greater China. Clingenix is based in Sunnyvale, Calif., and has operations in Taipei, Taiwan, and Beijing. Excerpts: Will China be a major global player in biotechnology?  China is becoming a world center for biotech R&D. A key factor in this transformation is the ample supply of well-trained chemists and biologists produced in recent years by the nation 's leading universities. The cost for this high caliber work force is very low â€”as little as one-tenth the cost in the US. This situation is similar to what has happened in the infotech industry. Biotech is one of the key industries identified by the Chinese government. China's entry into the World Trade Organization (WTO) in 2001 and its determination to promote high-tech, knowledge-based industries will shape the future of biotech enterprise in China, This government support will have a positive impact on how innovative biotech R&D will be conducted and protected in China. The Chinese government spent more than $180 million between 1996 and 2002 to help build a life science industry with a work force of more than 20,000.Government funding will increase to $600 million (Rs 3,000 crore) by 2005. The focus for China's biotech industry has been agriculture production and sales of imported vaccines and biotech protein drugs such as recombinant insulin and interferon-alpha and Traditional Chinese Medicine (TCM). Major research centers are the Beijing Genomic Institute and the Chinese National Human Genome Center in Shanghai, the National Engineering Research Center for Biochip Technology, Beijing, the Beijing Hypertension League Institute and Shanghai Traditional Chinese Medicine Innovation Center. Going forward, China is most likely to focus on developing its own innovative technology for molecular diagnostics, management of infectious and metabolic diseases, stem cell research, pharmacogenomics and clinical trials of TCM. There is pressure on China to comply with international standards. The Chinese biotech industry will abide by international rules simply because most companies want to collaborate with foreign research groups, publish in international journals and attract overseas investments. Does China have a private biotechnology sector? How are companies funded? Many Chinese biotech companies specialize in production and sales of biotech protein drugs and vaccines using recombinant DNA technology. Most of these biotech drugs are approved protein drugs and vaccines that have been in the US and European markets for many years. Chinese companies imported the complementary DNA sequences for these genes and can produce eight of the 10 best-selling biological drugs in the US Sales are limited to China. By the end of 2000, there were 21 biotech products available on the Chinese market. Only three were developed in China with patent protection. The biotech sector has turned out to be one of the most promising industries in China, generating a total sales revenue of nearly $3 billion (Rs 15,000 crores)in 2001 compared with $31 million (Rs 155 crores)15 years ago. The biotech companies are funded through four main sources: state-sponsored grants; joint ventures with research institutions such as commercial biotech ventures spun off from existing state-run medical and technology institutions; venture funds from traditional, well-established private companies such as China Petro and China Tobacco; and foreign investments from Hong Kong, Taiwan and Singapore. The concept of venture capital investing was recognized by the Chinese government as early as 1985. Many official policies promoting tech transfer from research institutions to private industry have since been published. However, the progress has been very slow mainly due to the lack of meaningful laws and regulations that adequately protect the venture capital investments in biotech. Private money is beginning to flow into China's biotech sector. However, most private fund managers are not as sophisticated as their Western counterparts. They lack the technical knowledge required to adequately evaluate the potentials as well as the risks involved. As a result, investments by the Chinese venture capitalists tend to be small. A typical China venture capital portfolio concentrates on companies with biotech products already approved or near approval in the West. At present, most foreign investors are from Taiwan, Hong Kong and Singapore. With a few exceptions, most venture capital firms in the US and Europe are still holding off until they are assured of a realistic exit route for their investments. The total investment for an average biotech company in China ranges from $1 million to $6 million(Rs5-30 crore). What are the challenges in setting up collaborations in China and the US? Funding is one challenge. Biotech, especially innovative biotech, is not cheap. It requires a long development time and can carry a very high risk. Very few Chinese venture capitalists realize that. Intellectual property (IP) protection is another challenge. Because of IP concerns, the US companies should take special care to state clearly in contracts the provisions for technology transfer to the Chinese company or joint venture. Most Chinese are also unfamiliar with Western management methods. Standard operating procedures are a must. There is also a lack of marketing know-how in China. Although highly trained technically, many Chinese workers lack the necessary business skills to market and commercialize sophisticated, hightech bio-products. Pricing is another challenge. The government and its affiliates act as both the primary clients for products and the authority that sets prices. This can lead to unreasonable pricing that can change unexpectedly. In the US, there is a lack of knowledge about Asia. Most of the US venture capitalists still have a wait-and see attitude. Many are misinformed about China today. They are unwilling to acknowledge cultural differences between the East and the West. This can result in misunderstandings between corporate managers and investors. The depressed US market conditions affect China. Because of the geopolitical situations, many US investors are reluctant to put more money into any biotech or high tech venture. There is a higher burden of proof for biotech companies with plans to invest in China. How have the current depressed market conditions in the US and Europe affected biotech development in China? These depressed market conditions in the US and Europe actually provide an opportunity for companies with the right technology and right management team to succeed in both regions. Young talent, trained in the US and Europe, is returning to China, reversing decades of brain drain. Thousands of well-trained, bilingual, bicontinental Chinese who got their education in the West are returning to China as entrepreneurs to seek technology and business opportunities in China's development boom. These soon-to-be leaders, with a professional standard and global mindset, are helping to reshape the Chinese society and its way of doing business with the rest of the world. Some academics are returning to China for the intellectual freedom that they cannot find in the US and Europe, especially in the area of stem cell research. How long will it take the emerging biotech industry in China to become competitive with the US? It will take from five to 10 years, depending on which areas of biotech you are discussing. In China, the one-child policy has resulted in a severe population imbalance. By 2015,China will have 200 million people over age 60 and this number will double to 400 million by 2050,representing 25 percent of the total Chinese population. Disease prevention and management in the elderly is becoming a national priority and is driving biotech research. In the area of stem cell research and its clinical applications, China may quickly become a leader because the Chinese scientists have resources to conduct research in this area. Stem cell research and related medical applications are viewed favorably by the Chinese government and Chinese people. Agricultural biotech is another focus of the Chinese government. Feeding a population of 1.3 billion requires constant improvement of crops. This includes the guided use of genetically engineered foods. In recent years, tight, new international standard regulations have been proposed by the government. China spent about $40 million Rs 200 crore) on plant biotech in 2000. The developers of TCM in China, working with Western companies and scientists, are using modern research tools and standards to develop next generation TCM products. These include fractionation of TCM to identify active compounds, testing first in mice and rats, then conducting standard human clinical trials. About 40 clinical trails of TCM products are being conducted in China and Taiwan. Courtesy : Beyond Borders: The Global Biotechnology Report 2003 by Ernst & Young. ]]> <![CDATA[From Pomato to Protato]]> https://biospectrumindia.com/news/95/1273/from-pomato-to-protato.html https://biospectrumindia.com/news/95/1273/from-pomato-to-protato.html Mon, 21 Jul 2003 22:07:00 +0530 Bending it unlike Beckham Biotechnology cannot be left in the hands of trigger-happy scientists who are excited at the use and abuse of something called gene gun. I was taken by surprise. The BBC Radio presenter, who was busy talking about football star Beckham, suddenly shifts to genetically modified potato and tells his listeners that he has a food policy analyst on line from New Delhi. And before I respond to his greetings, he fires the first googly: "When will you stop treating the multinational corporations as wicked?" Knowing that it was a live and a popular breakfast program, I had little time to react. "I think this question should be directed to the multinationals," I replied, adding "as far as I am concerned, I would stop treating them as wicked the day they stop acting wickedly." While I was still drawing the link between multinational corporations and the GM potato being researched in India, the commentator asked: "Why are you opposed to the GM potato which is reported to contain 40 percent more proteins that could be the answer to India's mounting problem of malnutrition?" "Who gave you these fake protein figures?" I asked, explaining "the GM potato that is under research contains not more than 2.8 percent protein, a mere increase of 0.6 to 0.8 percent protein than what exists in the normal potatoes." Well, this is what has been claimed by the secretary of Department of Biotechnology (DBT), he quipped, adding "but don't you think that even a little increase in proteins would help?" "What a shame. Those who talk of addressing the acute malnutrition crisis by feeding GM potatoes containing 2.8 percent proteins must be living in a fool's paradise," I reacted angrily. "If they are really sincere in fighting malnutrition, they should ensure that the 50 million tonnes of foodgrains that is rotting in the open is first fed to the hungry. And before you ask me why, let me tell you that over 25 million tonnes of food that is stocked and rotting comprises wheat, which contains four time more proteins than potatoes." A couple of more questions and the live interview ended. The BBC presenter turned back to more juicy stuff on Beckham, his interest in India's hunger and malnutrition being as superficial as that of the biotechnologists. But no sooner I was back in my office, another reporter was on line, this time from Paris. He too was seeking my reaction to the claims made by Manju Sharma, secretary, DBT. In three days, after Manju Sharma had made the tall (but false) claims at an international conference in France, the global print and electronic media had literally chased the story as if it was likely to lead the way to unearth the "weapons of mass destruction". And that reminds me of another obtuse research claims that had donned the front pages of newspapers in the early 1980s. Scientists had succeeded in crossing potato with tomato â€“ and they called it pomato â€“ hoping that it would increase the shelf life of tomatoes. The skin of the tomato would become thicker and that would mean that housewives would not have to throw over-ripe tomatoes every other day. Many newspapers had come out with editorials praising the effort of the scientists, probably meant to make for light reading. Mercifully, we did not hear of the "scientific" feat again. The scientific world has certainly come a long way since the days of pomato. In the days of genetic engineering, when all kinds of permutation and combinations are being ruthlessly tried by the neo-breed of biotechnologists and with the multi-billion dollar biotechnology industry waiting for a miracle to rescue its flagging reputation, protatoâ€”as the GM potato is calledâ€”is being promoted as the magic bullet. Scientists are giving an impression as if they finally have the technological remedy to fight the scourge of mankindâ€”silent hunger. "Hidden hunger" or "silent hunger", as it is called, is the new buzzword in the scientific echelons. Nearly 30 years after the advent of green revolution technology, scientists are rediscovering the importance of nutritional security for masses. The desperation is not in reality aimed at addressing the problems of "hidden hunger" but more tuned according to public acceptance to the controversial science and technology of genetic engineering. Such is the haste to promote the faulty technologies that Manju Sharma has even gone to the extent of saying that she would push for protato to be included in the mid-day meal program for school children. Potato would sprout before they reach the school children. And wheat, which is lying stacked under the sun, contains on an average eight to nine percent proteinsâ€”roughly four times more than what protato containsâ€”and that too without any harmful effects associated with GM foods. It would make terrible economic sense, if the biotechnologists were for once to forget the "novel" foods under preparation and urge the government to speed up food distribution among the hungry masses. After all, bulk of the surplus foodgrains that lie stocked in the open have already turned into cattle feed. Biotechnologists too are a part of the society and cannot simply shrug-off their responsibility by blaming the government for food mismanagement. Let us try to understand the reasons for the growing malnutrition. For an average Indian, the common menu revolves around dal and roti. While the roti is easily accessible (if you had the purchasing power), the availability of dal has been on a continuous decline. Pulses being the crop of marginal areas, were ideally suitable for the rainfed areas which account for 70 percent of the country's land under plough. Pulses require very less water and are known to enrich the soil by fixing atmospheric nitrogen. The neglect of pulses pushed the prices of the common dal beyond the reach of an average Indian, with the result that micronutrient deficiency continued to grow. Pulses on an average contain 20 to 24 percent proteins. Any effort to increase the production of pulses would have helped reduce the prices thereby making it easily accessible. It didn't happen. Instead, the country, which consumes the largest quantity of pulses gradually turned into a major importer. India today imports pulses in large quantities from Australia and Canada. Such were the lopsided policies that in fact, at one stage, India was contemplating "contract farming" for pulses in Africa to meet the country's need. There has been no effort at all to encourage the domestic farmers to cultivate pulses and pull the crop out from the marginal areas. As a result, pulses output continues to hover around 14 million tonnes. If only the money that is being wasted on fruitless application of genetic engineeringâ€”like the protatoâ€”were to be diverted for research on pulses, the country can build a real sustained answer to malnutrition. At the same time, production of cereals continued to grow. With globalization adding on to unemployment, even the cereals increasingly went out of the reach of the masses. With the result, the country is saddled with over 50 million tonnes of wheat and rice whereas some 320 million people go to bed on empty stomach. Agricultural scientists have steadfastly refused to address the problem of mounting stocks terming it as a political problem. But when the political masters started asking farmers not to produce more, and questions began to be raised about the relevance of the massive agricultural research infrastructure (the second biggest in the world), agricultural scientists began looking for opportunities to justify the public investment into a redundant white elephantâ€”the Indian Council of Agricultural Research (ICAR). "Golden rice" was the first such magic bullet. The ICAR was quick to latch on hoping that it would perhaps salvage some of its lost prestige. And then came the magic of GM potato, which is being developed by a team of scientists led by Dr Asis Datta, a former vice-chancellor of the Jawaharlal Nehru University, New Delhi. The transgenic potato that is under field trials, has a gene called AmA1 from Amaranth that provides a third more protein than what is normally available in potato, including substantial amounts of the essential amino acids lysine and methionine. Potato, on an average, contains 1.98 percent protein. Even if its availability has been enhanced by a third, the protein percentage comes to 2.8 percent. How will this "protein-rich" potato help to solve malnutrition in the country? How will the country's nutritional security be addressed? At the same time, it is high time that the country first evolves the national priorities for which biotechnology research tools are crucial. Biotechnology cannot be left in the hands of trigger-happy scientists who are excited at the use and abuse of something called gene gun. Learn to bend it like Beckham. Then only you can score a goal. Devinder Sharma   ]]> <![CDATA[The Bio-manufacturing giant]]> https://biospectrumindia.com/news/95/2581/the-bio-manufacturing-giant.html https://biospectrumindia.com/news/95/2581/the-bio-manufacturing-giant.html Mon, 21 Jul 2003 22:05:00 +0530 Like most successful companies, Sartorius India too started in a small way and worked its way up. Today it is among a select few companies which manufactures bioreactors used widely in the biotech industry. Its contributions were recognized when it was recently given the first Rabo India Bio Business award for the Best Exporter. The quest for excellence began in 1991, when SFS Technologies, started virtually out of a garage by Cherian Philip, struck a technical and financial partnership with the Sartorius group of Germany. The company started with the aim to make a mark as a synonym for India's excellence in the engineering sector. Today this foresight is paying Sartorius rich dividends, making it the only Indian company manufacturing bioreactors. And it has few competitors across the world. It acts as a single-window solution provider for pharma-bio process engineering, bioreactor design and engineering, membrane and separation technology, quality control expertise, validation process optimization and weighing technology. The Indian unit further enjoys the status of being one of the three system manufacturing facilities of Sartorius worldwide, after Germany and the US. The company exports its high quality products all over the world. The Sartorius India team has a strong entrepreneurial streak and a technically sound engineering service group. The company's success is also attributed to a large extent to its fluid organizational structure and initiative for partnering and outsourcing. These qualities help it react fast to tap various opportunities in the market place. In the last two years Sartorius has completed several complex biotech projects with companies such as Biological E, Lupin Chemicals, Alembic & Zydus Cadila on the home front, in addition to tapping a highly demanding export market. Sartorius India has grown, leveraging its experience with the pharma-biotech industry to manufacture state-of-the-art bio-reactors, upstream and downstream equipment for R&D. It mainly works in the design, manufacture, implementation, commissioning and participates in the initial production process for clients within a tight time frame. Now Sartorius has three units in Bangaloreâ€”one manufacturing center and two testing centers in Peenya. Sartorius is also planning to tap the food and beverages market in a big way. To begin, the group has acquired a German-based food and beverages company, Diessal, to offer best quality products for people in India. "The actual boss is knowledge and whoever contributes to it benefits the business." Dr Anil Paul Kariath, chief operating officer of Sartorius India Pvt Ltd, has over 25 years of experience in the biotechnology industry. Prior to his stint with Sartorius, he was with Indian Immunologicals where he set up a vaccine plant in collaboration with the Wellcome Foundation, UK. At Indian Immunologicals, he had worked in various disciplines such as quality control, production, process development, R&D and technical services. Since 1998, he has been associated with Sartorius India in developing fermentation and bioprocess equipment indigenously and specialized in design, manufacture and validation of bio-equipment. A postgraduate from Animal Biotechnology Center, Cambridge, he later did research at the Animal Virus Research Institute at Pirbright, UK. He has to his credit more than 20 publications in various journals of repute including the manual for vaccine production. Dr Kariath explains about the company's efforts in bio-manufacturing and processing. Excerpts: How did Sartorius India start? Who was the person behind this effort? Our former managing director, Cherian Philip, who is also a direct shareholder of the company, started Sartorius India. With his experience in the field of selling filters for biotech companies, he realized that India had the potential to contribute globally to the biotech-engineering sector. Thus in 1991, Sartorius started its operation, in India as an engineering unit to ensure value addition to the products which were imported from Germany. During that time, the cost of engineering products from Germany was so high that it was not very affordable to the pharma industry in India. The immediate objective was to meet the customer requirement in terms of cost effectiveness. But then, he found that the company per se was only working in certain pockets of the total value chain. To tap the entire value chain , the company needed professionals. That was the time when I joined the company. It was in the year 1997. The initial target of Sartorius India was to manufacture equipment required by the pharma and biotech industry within 12 months. The German head office did not appreciate this. A year down the line, it realized that what we were doing was the right thing and it decided to come into this business. That was a transfer of business opportunities from India back to Germany. It decided to amalgamate the two companies for better results. What are the core activities that Sartorius is involved in? How does Sartorius India differ from Sartorius Germany? The German company has been in existence for 130 years but did not move from its core activity of making filters and weighing balances. After getting the idea of value addition from Sartorius India, it acquired more than 10 companies all over the world. Realizing that the work in fermentation is highly skilled and knowledge-based and not easily available all over the world, Sartorius started a foray into the food market. In 1998, Sartorius made a serious attempt and recognized it as a huge market. Over 70 percent of the total turnover of the company is now from the food market. Also we came to realize that we could send people from India out to fill the gap in knowledge. The German headquarters asked for people and we sent about 10 people there who met the technical requirements. We are concentrating mainly on the software, automation, validation and documentation areas. Today, we serve our group globally. You have won the first Rabo India Bio Business Best Exporter award. What is the marketing strategy adopted by Sartorius? We are very proud about the award. Our strategy is to provide our customers the equipment in the shortest possible time at a price that is affordable. In the pharma and biotech sectors, the time for marketing an instrument is a key point. We are providing our customers this facility of quick delivery and our clients have that confidence in us. All this pride comes from the strength of the people. Our workers are very much dedicated and the teamwork brings us the pride. I believe teamwork is everything. And there is no differentiation between the workers and the boss. The actual boss is knowledge and whoever contributes in this process benefits the business. The company today exports more than 80 percent of its equipment to countries like US, Taiwan, Korea, Australia and Germany. How do you see the future of biotechnology in India? In India there is always the possibility of finding the resources to work and do it much easier and faster. There is no lack of it. India is a country which is very strong in engineering and engineering subcontract, except in logistics and infrastructure. Our government is giving a good support. For the last 2-3 years, we have not found a single hurdle created by the government and this is without having to pay anything extra. The role that government is playing in this export sector is helping us to increase our efficiency. For example, within 24 hours, they issued us an advance license for importing the food items for manufacturing exports. That's a record time. In Bangalore, the customs, excise people and the director general of foreign trade are extremely exportersfriendly. What is the financial status of Sartorius now? Public shares are worth Rs 1 crore, i.e., about 10,000 shares. Our turn over is Rs 50 crore this year against the Rs 1.5 crore five years back. What are the barriers affecting the Indian biotech industry? The entry level barrier is the high cost for a start up. Hence, it has not yet become every man's dream to set up a biotech company. Venture capitalists and banks are doing a great job but still have to realize the needs of those start-ups. The new comers can take the help of private funders for their infrastructure facilities. There should be an incubator facility for the start-ups. IPR is another major problem in this sector. The time to market has to be reduced and the risk of financing a new entrepreneurs can be diluted through such incubation centers fully independent of government. The biotech industry should work on issues which are mainly relevant for our country. The primary focus should not be the European market. It should meet the requirements of underdeveloped countries. The need is to create a common facility for all and make sure people can take advantage of it. We are waiting to play a small role in this at the TICEL Park in Chennai and also at Bangalore and possibly in Pune. We will be giving physical assistance for setting up the park. What is the scope of biotech industry in India? India offers a huge market for biotechnology. Trends reveal that India will attract more than $200 million in the next five years in biotechnology. The Indian biotech industry is expected to grow at a rapid pace and the growth will primarily result from the increasing R&D collaborations of Indian companies with foreign and domestic firms. Many factors have been instrumental in fuelling the growth of the biotech industry in India. They are low cost of manufacturing and innovation as compared to those in developed markets and the government support. The Department of Biotechnology funds several R&D projects across India. R&D infrastructure owned by government agencies like Indian Council of Medical Research (ICMR), The Council of Scientific and Industrial Research (CSIR) and Department of Science and Technology (DST) are helping entrepreneurs. But there are certain hurdles, which have to be solved. We need to wipe out the poor image of Indian engineering products. To this end, we must set up a body to help assist the industries upgrade their knowledge of various standards in this field, and provide assistance in quality improvements. Roby Ajith ]]> <![CDATA[The Separator]]> https://biospectrumindia.com/news/95/2783/the-separator.html https://biospectrumindia.com/news/95/2783/the-separator.html Mon, 21 Jul 2003 22:03:00 +0530 With a robust strategy, Alfa Laval (India) has seen a quick turnaround in its fortunes in recent years. Buoyed by the success, the company is making rapid strides to become the country's leading supplier of equipments to the biotech industry. Amidst stiff competition in the supplier market, Pune-based Alfa Laval (India) Ltd has surpassed its previous records of net profit and dividend last year. The company successfully withstood the negative business sentiment that prevailed most part of the year. The company put up a good growth on the export front with the export figures accounting for about 28 percent of its total sales. With a comfortable order book position, the company expects to have a good year this fiscal too. Success for this leading provider of specialized engineering solutions is on account of its strategic planning and vision in handling business opportunities and able leadership. The message of its leader, Satish Tandon, who is the managing director, is loud and clear. "Recession is mainly a state of the mind. For doing bad business one cannot blame bad times. In fact, trying times give fodder to the challenging spirit of an organization and at the end of the day the results speak." For Alfa Laval, the above sentiment is more than a statement. During the year ending March 1997, it was in red, showing a whopping loss of Rs 30 crore. It was at the time that Tandon took over as the managing director. Sensing trouble, he got his priorities clear and led the restructuring process and clamped the unnecessary costs. The layers in the management structure were reduced and its market presence strategically increased, strengthening the sales force. The objective was to improve the bottom line through right product-mix, based on market segments. With that shift in focus from volumes to profitability and discarding of non-profitable products, Alfa Lavel's fortune changed. In two years, the company made a turnaround and in the year ending December 2000, it reported a record profit of Rs 24 croreâ€”the highest ever in the history of Alfa Laval in its 65 years of operation in India. In 2002, Alfa Laval achieved a new milestone with a record net profit of Rs 45.35 crore. Global as well as local Its style of operation is thinking global, acting local. It is the arm of the leading engineering Swedish multinational, but has been strongly entrenched in India for more than 65 years, manufacturing and marketing key process components and systems for centrifugal separation, heat exchange, drying and evaporation and flow transfer. It addresses as varied segments as marine, diesel, nuclear and thermal power, brewery, distillery, biotechnology and pharmaceuticals, effluent handling, edible oil processing and health food. It has established itself as a supplier of high-quality fabricated and separation products in the biopharma applications and this sector is set for continuous growth and the company also expects to grow its business in this field. Biocon was its first biotechnology client. Alfa Laval expects a growth of 13-15 percent from the life sciences segment. Its client base in biopharma and biotechnology includes Ranbaxy, Dr Reddy's Lab, Wockhardt, Cipla, Novartis, SmithKline, Aventis Pharma, and Biocon India. Alfa Laval is actively pursuing the export market. It has set up a purified water injection plant in Bangladesh and another in Algeria. It got a similar order from Oman Pharmaceuticals. Alfa Laval has a long experience of solving separation problems in the biotech and pharmaceutical sectors. It offers a wide range of dedicated centrifuges capable of handling all dutiesâ€”from small lab scale up to continuous, full-scale, high-capacity production. The separation technology is used for cell separation, organic/amino acids, antibiotics, enzymes, vaccines, harmones, starter cultures and vitamins. Going forward Alfa Laval (India) was a pioneer in bringing single fermenter continuous fermentation technology to India in the late Eighties. Distillery plants using Alfa Laval process produce spirits ranging from excellent quality potable grade rectified spirit to technical grade alcohol suitable for conversion to bulk chemicals and speciality chemicals. Today sections for producing extra neutral alcohol for fine liquors, dehydrated alcohol, perfumery grade alcohol, pharma grade alcohol etc. can be added on and made a part of the system installation. The company has executed over 50 complete distillery projects. With the government's policy now mandating the mixing of five-percent ethanol in petrol for reducing harmful emissions and this limit expected to be increased to 10 percent and beyond, it expects to generate a sizable business over the next few years. "I see India as a major hub for fuel ethanol production in near future, "says Tandon. It has tied up with Katzen International Inc. of the US for the vapor-phase molecular sieve technology and an absolute alcohol (fuel ethanol) plant has been commissioned at Faizabad. The plant is completely automatic and is operated using a PC by a single person. The feed of 93.5-94.5 percent alcohol is passed through molecular sieve column, which absorbs water molecules and the resultant product is more than 99.8 percent pure alcohol, which is called fuel grade alcohol. It has installed its second plant (fuel ethanol from sugarcane juice) at Herwad in Kolhapur district. It is the first of its kind in India. Further, it sees opportunities in the exports market as the demand for portable alcohol as well as ethanol is increasing in South East Asia. It recently bagged a large order in Vietnam. Alfa Laval gives top priority to satisfy its customers at any cost. Tandon sums it as: "At Alfa Laval, we believe that in this fast changing technological environment, providing right solutions is not merely a matter of plugging in the latest technological wonders. We take special care to critically evaluate and understand the nuances of our customers' businesses. And then to offer the technology, solutions, support and professionalism ... to give them that "winning edge" that keeps them ahead in a race that never ends." "India will become a major hub for ethanol production" Satish Tandon, managing director of Alfa Laval (India) and chairman of its associate companies, explained to BioSpectrum about his future plans. How do you see the biotech market in India and abroad grow? Life science is an upcoming market in India. I see a positive trend in the next three to four years for biotechnology in India. Looking at the present growth rate, I understand that biotechnology in India is expected to grow at 20- 22 percent. Outside of India, Bangladesh and East Africa are potential markets. Life science will emerge as a major sector in these countries. But all depends on how you compete in these countries. It is very difficult to compete in the developed markets like the US and European Union because of the stringent norms in these countries. In these countries, maintaining the effluent plants will be more expensive than establishing a new plant in a developing country. What is the scope of ethanol/anhydrous alcohol production in India? India is the best market for ethanol production. We see a lot of export potential for this sector. More companies are setting up shop in India and our own requirements are enormous. At present, the government of India has made mandatory the use of five percent ethanol-blended petrol. It is also considering increasing the use of ethanol blending to 10 percent and further to 20 percent in phases. This I feel will bring in competition in the field. More the competition more the business. At present we are holding 30-40 percent of the market share in this sector. Why are distilleries reluctant to upgrade the set up for production of anhydrous alcohol, when the government is committed to implement the mandatory use of five percent of ethanol blended with petrol? Looking at the present economy, the people in the industry have become very cautious about investments. Once investments are made, nothing can be done. And one more thing is that implementation is a slow process in India due to various things. India is a learning economy. But still, we have seen a lot of changes in the last five years. With the reduction in import duty for equipment for biopharma industry, are suppliers losing their market share? With the opening up of markets and globalization, we have to prepare ourselves for competition. And globalization is essential for any organization to grow. We have to compete in this market. In the life sciences sector, we find only the big players. They can invest or bring in more funds for expansion or for up gradation. They can even go for foreign collaborations for their R&D work. But we cannot expect the same for ethanol production units or the distilleries which are manufacturing anhydrous alcohol. This is because we find over 70 percent of these units are managed by co-operatives and managed by nonprofessionals. Sugar cannot be a viable product unless it is produced with a blend of products like generation of power, ethanol, alcohol etc. The sugar manufacturing units have to come out from the present style of functioning i.e., from the private atmosphere to a business atmosphere. Narayan Kulkarni ]]> <![CDATA[Herbal Harborage]]> https://biospectrumindia.com/news/95/2478/herbal-harborage.html https://biospectrumindia.com/news/95/2478/herbal-harborage.html Mon, 21 Jul 2003 21:59:00 +0530 The legendary royal garden of the erstwhile Oudh kings, "Sikander Bagh", who ruled the region during the 19th century before being taken over by the British in 1857, is today the home of the premier national plant research center in the country. And NBRI is celebrating the global jubilee of its formation this year. Over the past fifty years, it has made patient strides scouting for patents and plants. CSIR took over the National Botanical Garden in 1953 and expanded the scope of the institute into a multidisciplinary plant research centre and it was renamed as the National Botanical Research Institute in 1978. Ever since, the institute has produced innumerable varieties in horticulture, products as functional foods and filed almost 30 patents in India and abroad. Today, it is an internationally known research center that focuses on both basic and applied research in various aspects of plant sciences for the conservation and sustainable utilization of plant genetic resources for human welfare. Plant health, economic wealth What keeps NBRI going? Dr P Pushpangadan, director, NBRI explains, "Unless we love the nature, it is difficult to work for it. To sustain our natural harmony, we all have to work for the same. At NBRI, we are all working to produce good quality eco-friendly products." Its mission is to be a premier national and international center on plant science research and development, be the prime catalyst in the conversion of plant wealth into economic wealth and develop as a national referral center for the knowledge base related to plant biodiversity. Offering consultancy and technology, today, it caters to the needs of every aspect of plant research in the South Asian region in general and India in particular. In that mission, its practices encompass biodiversity, bioinformatics, biomass biology, biotechnology, conservation, ethnopharmacology, floriculture, plant physiology, genetics and plant breeding, molecular biology and genetic engineering, natural product development, etc. NBRI is rich in scientists and knowledge base. For instance, Dr Rakesh Tulli and his group work in the area of plant molecular biology. Dr Tulli informs, "The main objective of our work is to develop transgenic plants improved for agronomically important characters. Characterization and designing of genes for toxicity to insects is also a part of our research. Apart from these, we also offer consultation and contract research for the biotech industry." Dr Shantha Mehrotra is another eminent scientist there. The Department of Science and Technology presented her the leading women scientist award recently. She is working on identification, authentication and evaluation of medicinal plants/raw drugs by modern pharmacogenic methods which include correct taxonomic identification of plants and their parts, macro-and microscopical details, histochemical and biological analysis of the plant parts used as medicine, SEM studies of plants parts. Mehrotra adds, "We are working on to produce quality evaluation and standardization of herbal drugs and products and scientific validation of ethnobotanical claims." With a rich heritage of research, the institute is not confining its research activities to the laboratories alone. It is looking at spreading awareness among the masses through various means and ways. Says Dr Pushpangadan, "We have established a garden for "housewives" in to which we welcome housewives and educate them about the easy biotech application in their daily life. We also have a lab exclusively for kids. In this lab, kids can use any instrument they like. These are the various types of awareness programs which NBRI conducts regularly." NBRI recognizes that technology developed in any laboratory cannot be considered as successful unless it reaches the market. Agrees Dr Pushpangadan, "It is always difficult for the scientific society to develop the skills to market their inventions. For that we opt for industrial collaborations. But at NBRI, we are planning to recruit proper MBAs for marketing our products. This way we can reach the market in a proper way. CSIR has granted two posts for the Business Development Unit at NBRI." The message from NBRI director is crystal clearâ€”"Biodiversity and the associated indigenous knowledge systems are the two invaluable capital assets of countries like India. They can be utilized profitably to generate a number of IPR-covered high value products and technologies for domestic as well as international trade." "Personalized medicine is the future of modern medical field" NBRI director Dr P Pushpangadan outlined his organization's future plans to BioSpectrum. What are the emerging segments of plant biotechnology? Herbal technology is an emerging field. It has applications in areas like cosmetics and health food. The institute is very much involved in programs of linking traditional knowledge into biotech. This is called herbal technology. NBRI has also set up a "Herbal Standardization Committee", the motive of which is to identify the right raw material for making any herbal drug. We develop drugs of preventive, promotive and corrective in nature. Nutraceuticals is another form of herbal-based preventive and promotive medicine. NBRI is actively working on developing nutraceuticals. The main objective of the institute in this area is to identify the natural sources for phytochemicals/phytonutrients and development of technology package for nutraceuticals/functional foods as health care system. To what extent has India's biodiversity been explored? The utilities of the Indian plants have been explored only to some extent. This is because we do not have any databases available for the same. Neither have we any "shared" knowledge base on this issue. Tribals have very good knowledge of biodiversity but we cannot use it. NBRI is actively involved in making a "Passport Data of Important Wild Genetic Resources" with reference to their aromatic and herbal values. We are also working on categorizing the toxicology of plants. We are working along with the representatives of other medical fields as like Ayurveda, Sidha, and Unani. In this way we are trying to build a bridge between gene-diversity and traditional wisdom. What is the future of diet, food and medicine systems? Personalized medicine is the future of modern medical field. Under this, doctors will explore a patient's gene and then give the dosage accordingly. Scope of personalized food is huge. Especially for the diabetic or heart patient, personalized medicine and food are needed. At NBRI scientists have developed herbal products for children, designer food for patients of hypertension and diabetes and functional food for pregnant women. Nutritive security is widely needed in the case of pregnant women. We have categorized the nutritive requirement of women as per the development stages of the child. As a functional herbal drink, we have produced "Nibra" as a healthy soft drink with 1 per cent alcohol. How do you rate traditional medical practices such as Ayurveda, Sidha and Unani in this modern world? These traditional medicinal practices have some very important qualities which can easily be absorbed into modern medicines. Their values can be understood after having a look at the present western culture. The western people are more inclined towards the Ayurveda than the Indians. We have involved experts from Ayurveda, Sidha, and Unani in our NMITLI project to develop anti-virals for Hepatitis. This project is coordinated with RRL, Jammu, IICT and Dabur. What is the scenario of botanic gardens globally and where does India stand in this segment? In a global survey done by some US agency, it was written that about 200 million people around the globe visit botanic gardens every day. Though India has 145 botanical gardens, only 11 of them are of that standard which get more than 1,000 visitors daily. Research activities Here is a list of research areas at NBRI. Biodiversity research by inventorying, monitoring, assessment, conservation and sustainable utilization of plant genetic resource of India with special focus on medicinal, aromatic, dye and gum yielding plants. Bioprospecting for search of commercially valuable genes, biodynamic compounds and development of scientifically validated, value-added and standardized novel plant productsâ€”herbal drugs, pharmaceuticals, nutraceuticals and cosmaceuticals. Biomass biology including biopesticides, biofuels and petroleum alternatives, and environmental sciences including phytoremediation and abatement of terrestrial and aquatic pollution including studies on greenhouse gas emission. Bioinformatics by developing computerized/electronic databases on Indian plants with special focus on medicinal, aromatic, dyes, gum and tannin yielding plants and rare and threatened plants of botanic gardens and implementing applications of IT in plant science research and development of bio-information products. Biotechnology (biotech processes/ products) including trans-disciplinary studies on molecular biology and genetic engineering for development of transgenic plants. Genetics, plant breeding and agrotechnology includes selection and genetic enhancement for development of new promising varieties of economically important non-crop plants. Nutraceutical products Nutra-Preg 16: This product is for women who are one-six months pregnant. It is for optimum health of the mother and helps brain development of the foetus/infant. Nutra-Preg 79: This is for seven-nine months pregnant-women, used for the same purpose as Nutra-Preg 16. Nutra-Lact: A product for lactating mothers that succors good health and postnatal care of lactating mother and child. Nutra-Wom GH: This is for the general good health of women. Nutra-Kid: It helps the infants and children up to two years of age to have optimum physical growth and good development of nerve (brain). Nutra-Child: General good health of adults of all age groups. Nutra-Mind: A brain tonic Nutra-Immune: For general good health of adults of all age group. Nutra-Age: For general good health of the aged. Nutra-Diab: For general good health of the diabetics. Nutra-Pan-Ton: Pancreas tonic for diabetics. Nutra-Card: A heart tonic. Nutra-Speech: General good health and speech disorder therapy. Herbal products Lipstick, Luvstick: This is developed from purely natural herbal colorants composition blended with selected essential oils or aroma isolates that are capable of altering the mood and mental perception of the person who applies the lipstick. The aroma acts as mood lifting, antidepressant, anti-stress, stimulant, soothing, creative thought inducing, anxiety reducing, sensual pleasure providing, fragrant and refreshing agents. Fermented drink, NBIRA: It is a mild herbal beverage, like beer, with 2-3 percent alcohol content. NBIRA is fortified with other health protective and promotive attributes such as hepatoprotective, antioxidant, immuno-enhancing, anti-stress, and anti-fatigue properties. The beer is developed from a fruit, which is available in bulk and is cheap and has powerful antioxidant, immuno-modulator and diuretic properties. Soft drink, NBIRASOFT: These herbal drinks contain a combination of 5-6 extracts from indigenous medicinal plants, which are fortified with other health protective and promotive attributes such as hepatopro-tective, antioxidant and immuno-modulator besides providing instant energy and vitality. Dry color powder, Gulal: The invention relates to a process for the preparation of synergistic herbal dry color composition by lending of natural dyes with natural ingredients in specific proportions and under specific conditions. The resultant color powder thus prepared has synergistic action of natural dyes and natural ingredients resulting in good sticking capacity of skin and easily removable by soft mop. These colors can be used for playing Holi, cultural dances, and making rangoli. ]]> <![CDATA[Ocimum gets orders for OptGeneTM from Dow AgroSciences]]> https://biospectrumindia.com/news/95/1734/ocimum-gets-orders-for-optgenetm-from-dow-agrosciences.html https://biospectrumindia.com/news/95/1734/ocimum-gets-orders-for-optgenetm-from-dow-agrosciences.html Mon, 21 Jul 2003 21:50:00 +0530 Ocimum Biosolutions, Hyderabad, has announced the sale of its gene optimization bioinformatics software, OptGeneTM to Dow AgroSciences, LLC. Financial aspects of the deal were not disclosed. "Dow AgroSciences is one the leading companies in the world in plant biotechnology. We are very pleased to be working with Dow AgroSciences and meeting their needs in customizing this cutting edge product, OptGeneTM". We look forward to a continuing association with Dow AgroSciences" Ocimum's CEO Anuradha Acharya commented Dr. Don Merlo, Senior Research Scientist, Molecular Biology group for Dow AgroSciences said "OptGeneTM combines a whole suite of gene design and analysis packages into one user-friendly and user-customizable program that replaces three programs that I used previously". He added "I was amazed at the speed of Ocimum's customer response. With Ocimum having a team in India, the time difference between the US and India actually worked to my advantage, since answers to questions I encountered during my work day were worked on and solved overnight." OptGeneTM is a multi-platform compatible bioinformatics software that enables design of genes with optimized features for expression in organism of choice. The software exploits the redundancy in the codon usage to engineer desired features into the targeted gene. It comes with integrated user-friendly tools to perform various manipulations for efficiently achieving desired structural and functional features in the targeted gene sequence. It is the only product of its kind in the world. Ocimum is in the process of filing worldwide patents for this product. Bio-Rad offering Quality control service Bio-Rad India, a fully-owned subsidiary of US-basecd Bio-Rad Laboratories, has started a new service to create its need within the diagnostics industry. Bio-Rad has started a quality control practice for all medical laboratories. Explaining about the service the company's country manager, Dhiren Wagle said, "If you critically look at the diagnostics market of labs and pathologies in India you will find that there is a great need of any regulatory body to standardize the qualities of labs. The response is good from the industry and uptill now we have 120 labs as our subscribed members for this." Headquartered in Gurgaon, Haryana, Bio-Rad India has regional offices at Chennai, Mumbai, Kolkata, Bangalore and Hyderabad - all catering to the numerous research, industrial and clinical laboratories of India. The company's operations in the neighboring countries of Sri Lanka, Bangladesh, Nepal, Bhutan and Maldives are also coordinated from the Bio-Rad India office at Gurgaon. A fast-growing company dedicated to bringing quality in terms of products, services and new ideas into the life-sciences research and health-care sectors, Bio-Rad India has achieved Rs 34 crore in sales in 2002. Achieving quality control in a medical laboratory it requires using many technical tools. These include, procedure manuals, maintenance schedules, calibrations, a quality assurance program, training and quality control. "Quality control in the medical laboratory is a statistical process used to monitor and evaluate the analytical process, which produces the patient results," Wagle said. According to him, the statistical process requires â€” a regular testing of quality control products along with patient samples. And the other is comparison of quality control results to specific statistical limits. In addition, this is a value-added service. It is so, because any lab can avail this service without paying anything specifically for it. This is offered free with any of the products of the company. Government to support GM technology Agriculture Minister Rajnath Singh has reiterated that the government would support any technology, including the GM technology, that is risk-free and bring prosperity to the people. "However, the GM technology should be evaluated for its potential impact on human health and environment must be addressed if its benefits are to reach the farmers." Inaugurating the World Seed Congress 2003, the annual event of the gobal seed industry in Bangalore, Singh, ruled out any revision of targets for agri exports and invited global seed companies to set up joint venture with Indian companies and develop mutually beneficial business opportunities. "Today, the biggest challenge facing the seed industry is that of meeting the ever increasing demand for good quality seeds of different crops suitable for different agro-climatic zones," he said. Organized by the International Seed Federation, in co-ordination with the Association of Seed Industry and the Seeds Association of India, the congress may open up trade opportunities for the fledgling Indian seed industry and help India to learn about the latest technologies. Noted agriculture scientist Dr MS Swaminathan called for creating seed reserves to overcome genetic vulnerability enhanced by genetic homogeneity. "Seed reserves are crop security, just as grain reserves are important for food security," he said. The renowned scientist pointed out that "to sustain our agriculture progress, we need an evergreen revolution which could help us to increase productivity in perpetuity without ecological harm." It was imporant to develop a proper regulatory framework to emerge as a key player in global seed trade, said International Seed Federation (ISF) general secretary Le Buenec. "One of the key factors, in terms of exports, is adequate protection of intellectual property rights (IPRs). This proves to be a major concern for companies to export to India." For imports, India had to be a part of the international system of seed certification and member of the International Seed Testing Association, Buenec added. ISF president Christopher Ahrens said investment to India was restricted till now due to non-favorable conditions but this was expected to grow following the new policy initiatives. A key Indian organizer and Advanta India managing director Deepak Mullick said as per year 2000 figures, India exported $20 million worth of seeds which could be increased to $200 million by 2005 if all the requirements were put in place. "India has also got its first seed testing lab which could provide the Orange International Certificate required for exports. Two more such labs would be set up in the near future, he added. On the controversy over genetic engineering and genetically modified crops, ISF leaders said, "it is a technology that would solve many problems but it is not a tool to solve the entire problems of the world." "Though India ranks eighth among the world's top 10 seed producing countries, China is way ahead with its market size estimated at $3 billion as against India's $680 million," declared Manmohan Attavar, chief organiser of the congress Incidentally, the US leads the global seed industry with a whopping $5.7 billion domestic market, followed by China ($3 billion), Japan ($2.5 billion), Commonwealth of Independent States ($2 billion), Brazil ($1.2 billion), Germany ($1 billion) and Argentina ($930 million). Accelrys and Axxima collaborate to speed up drug discovery Accelrys, a wholly owned suubsidiary of Pharmacopeia Inc. has unveiled a three-year software licensing agreement with Axxima Pharmaceuticals AG. Axxima will apply Accelrys molecular modeling technology to target important infectious diseases such as HIV, Hepatitis C, and tuberculosis. Axxima aims to to speed up the discovery of novel drugs to treat these diseases. Accelrys software supports Axxima's strategy to fully integrate molecular modeling within its medicinal chemistry department, improving communication between chemists and modelers and leading to a more efficient process. A key element in the agreement is Accelrys LigandFit software which offers a broad range of structure-based design capabilities to allow rapid evaluation of thousands of drug-like molecules against protein target sites. LigandFit calculates the likelihood that a compound will interact strongly with a protein target, indicating promising lead compounds. Accelrys scientists will continue to work closely with Axxima to extend the validation of LigandFit for protein kinases, the primary class of targets studied by Axxima. This collaborative validation will enable Axxima to quantify virtual high throughput screening hits and to reach more rapid and reliable hypotheses. "We are convinced that LigandFit is a very promising technology and we are confident that it will optimize workflow and throughput in our drug discovery programs,"stated Dr. Andrea Missio, director of chemistry at Axxima. "It was also important to us that Accelrys could address all of our computational chemistry needs within a single environment." This agreement not only provides Axxima with a valuable research tool, emphasized Dr Scott Kahn, chief science officer at Accelrys, but it is also supported by joint projects to expand validation of our science in an important class of disease targets. The Accelrys approach is to work closely with cutting-edge research organizations to optimize our technology and to improve the impact of our science. Bt cotton a sell out this year Whatever the critics may say, India's farmers seem to have spoken about the Bt cotton seed. The message from them is loud and clear. They see Bt cotton as a success. And the farmers have put money where their mouths are and have placed huge orders for the Bt cotton seed marketed by Monsanto-Mahyco. So much so the seed factories of the combine are working overtime to cater to the demands of the farmers for the Bt cotton seed. And the supply is capped as the suppliers are not in a position to meet extra orders. "If we have more seeds, we would have been very happy to cater to the demands of more farmers," said a top Monsanto official. Sources in Monsanto said the Bt cotton seed is likely to be planted in some 700,000 acres in six states this year. Last year, the first year when the crop was introduced after the regulators approved its use in March 2002, Bt cotton seeds were planted in just 80,000 acres. The Bt cotton seed has a gene introduced from a soil-based bacterium, Bacillus thuringiensis, to induce immunity against a major cotton pest, boll worm. Over 50 percent of the pesticides in the cotton crop used by farmers are to give protection against the boll worm. With Bt cotton seeds, the use of pesticides against boll worm is eliminated. One acre of cotton crop requires 450gm of Bt cotton seed. In addition, each packet of Bt cotton is sold with 200gm of normal seeds as current regulation mandate planting of residual lines of the conventional plant as a safety measure. The combined packets of 450gm Bt cotton and 200gm conventional cotton seeds retails for Rs 1,600. Kolar Biotech to manufacture rDNA products The Mumbai-based Kolar Biotech is setting up a project to manufacture recombinant DNA. To provide technical consultancy and hand holding support for the project having estimated cost of Rs 33.98 crore, the company has retained Biotech Consortium India Ltd (BCIL). It will also take care of the technology transfer arrangement. The commercial production of the biotech project is scheduled to commence in April 2005. Sartorius India forays into new business The Bangalore-based Sartorius India is set to enter into new business areas following the parent company, German-based Sartorius AG. It has acquired another German firm Diessel to enable supply of bioproducts equipments to food and beverages (F&B) and pharma segments. Metahelix signs deal with NZ firm Metahelix Life Sciences, a Bangalore-based agri- biotechnology company, has signed a four-year plant functional genomics research agreement with ViaLactia Biosciences of New Zealand. The program involves the functional validation of a number of genes from pasture plants. India to generate a million jobs: E&Y The biotech in India is forecast to generate $5 billion in revenue and one million jobs over the next five years, reports the annual global biotechnology report from Ernst & Young (E&Y). To achieve this, India along with China is seizing the change to make therapeutically equivalent versions of biologics from western nations. They are now reluctant to do this because of the fear of losing intellectual property without compensation. Monsanto starts research on GM maize Monsanto has received a clearance to initiate research on transgenic maize, following which the sample seeds has been brought into India through National Bureau of Plant Genetic Research (NBPGR). Ranjana Smetacek, director - public affairs, Monsanto India, told BioSpectrum that the regulatory studies would begin under the guidance of Ministry of Environment, Ministry of Agriculture and Ministry of Science & Technology."As for location, we are exploring venues for pollen flow studies," she added. AP signs MoU with Canada A memorandum of understanding (MoU) was signed between the government of Andhra Pradesh and the province of Saskatchewan (leading Canadian agri-biotech state) for collaboration in the field of agri-biotechnology. The focus will be on crop, animal and environmental Biotechnology. The collaboration will extend to the areas of technology, research, regulatory issues and education. The MoU was signed at Washington by BP Acharya, industries secretary in-charge of biotechnology, AP and Larry Spannier, the deputy minister for Industries of Saskatchewan province. Centers identified for GM rice tech transfer The Department of Biotechnology (DBT) has identified centers in the country for transfer of the 'golden rice' gene in established traditional rice varieties. The Tamil Nadu Agricultural University is one of the identified research centers for this technology transfer. Under the Indo-Swiss collaborative program on biotechnology (ISCB),the DBT had given the right to supply the seeds to research institutions, breeders and biotechnologists "to optimize the trade in many respects and eventually provide an area-specific rice line for the people". ]]> <![CDATA[BIOTECH PARKS - What they should be?]]> https://biospectrumindia.com/news/95/2205/biotech-parks-what-they-should-be.html https://biospectrumindia.com/news/95/2205/biotech-parks-what-they-should-be.html Mon, 21 Jul 2003 21:48:00 +0530 Specialized parks can patronize the biotech industry in the country. Biotech, like infotech, is a new area and a hi-tech one. It is for the first time in history that we have an area in experimental science where the borderline between basic research and its application has become extremely tenuous. This has been largely because of the fact that the vast proportions of biotech products are low-volume AND high-priced. For example, the daily requirement of an individual for vitamin B-12 is only 1µg. This means that 1 g of vitamin B-12 can take care of million people and 1 kg of it can cat-er to a billion people per day. So two tonnes of it would take care of the entire requirement of the world over a year, even if none of this requirement is met from other sources. It is for this reason that we have seen, in the last two or three decades, famous scientistsâ€”some of them being Nobel Prize winnersâ€”becoming entrepreneurs and millionaires. However, in every such case the individual was helped either by venture capitalists who were willing to take risk or by institutional support, often by both. Biotech Parks, the growth facilitators Biotech parks are a way to help those, who have the knowledge and expertise and the ability to turn the same into a commercial venture, to actually succeed. A biotech park does so by providing invaluable shared infrastructural support and facilities, which, if set up by an individual company for an exclusive in-house use, will cost enormously. Further, it will not be used to full capacity by any start-up. It would, therefore, be cheaper for a start-up to locate itself in a biotech park and use a central facility set up in the same campus by the promoters of the park, against payment for the time for which it is used. For example, a DNA sequencer can cost over Rs 1 crore. It may be absolutely essential for a biotech company but may be used by it for less than 5 percent of the time in the initial stages of the development. Thus setting up this facility as a shared facility in a biotech park could help many start-ups simultaneously. A corollary of what I have said above would be that in our country, a successful biotech venture can be set up only by the government (state or central) or a large public or a private sector company that can invest substantially and does not expect quick returns. An investment in a biotech park should be considered as a long-term investment as in education, be it in a university or a professional college. It is universally recognized that if the education that is provided is appropriate, worthwhile and thorough, the returns that the state gets through those who pass through the portals of universities or professional colleges, far outweigh the expense incurred on their education. The same would be true of biotech parks. Of the state governments in the country that have talked about the biotech parks that I am aware of are : Andhra Pradesh, Karnataka, Rajasthan, Uttar Pradesh (UP) and Uttaranchal. The last three have been in touch with me either directly or indirectly, at one time or the other. The biotech park in Andhra Pradesh has been, so far, nothing but short of a disaster. Bangalore has an industrial technology park (ITPL) which is extremely well equipped and satisfies a large fraction of the criteria mentioned in the box. It seems to operate efficiently and should serve as a model for other similar parks in the country, including specialized biotech parks. The UP government was in touch with me directly and prepared a document--a kind of a pre-project report--which was excellent and took into account all that has been said. The document needed to be converted into a full-fledged project report. That was the intention of those who got in touch with me on behalf of the UP government but, after that, the contact was lost and I do not know if anything has happened to the proposed park since then. The Uttaranchal government also got in touch with me and I referred to them the documents of the UP government. However, I doubt if any progress has been made in this new state. In the case of Rajasthan, I was contacted by a developer from Kolkata. It was apparently contracted to set up a biotech park in Rajasthan. However, the developer has not yet got back to me and not much progress has been made there either. The lesson that emerges from this experience is that if any one (be it in the public or the private sector) wishes to set up a biotech park, there has to be a clear deliberate policy decision in this regard, taking into account the requirements stated in the box. Then, adequate resources must be assured and the project carried out under the supervision of a competent, highly professional group that understands biotech and its requirements. This is yet to happen anywhere else expecting, perhaps, Karnataka. The Tamil Nadu government is intending to set up a marine biotech park which is an excellent idea as the state has a large coastal area. It seems to have contacted the right people to help in the setting up of the park. It, however, remains to be seen how serious the government is about it on a continuing basis. Every state in India has a unique set of natural biological resources. If biotech parks are set up in our states in a way they should be and meet the requirements mentioned above, I have no doubt that they will act as a major instrument for the optimal utilization of such resources through development of biotech in the state. What would help further is the tying of the biotech parks with organizations like the venture capital companies so as to aid the companies who propose to set up their facilities in the park with necessary support on due diligence. It is also important that such parks do not prohibit manufacture of biochemical products as long as the manufacture is done using lab-scale facilities. It would, of course, help further, if land around the park is available for purchase by the tenant start-ups (and only to them) for large scale commercialization. Biotech park: The success parameters Aesthetic modern buildings which are functional and low-cost, with facilities such as vacuum, compressed air and gas on line whereever required. A centralized instrumentation facility for DNA and protein sequencing, synthesis of peptides and oligonucleotides, NMR, various kinds of microscopy, a FACS machine, and ultracentrifuges, on a pay-by-use basis. Centralized services like cold-rooms, hot-rooms and freezers for storage, etc. A set-up for quick acquisition of material from outside India, specially fine biochemicals of low-volume and high-value, requiring special handling. A set-up to advice on patents and intellectual property rights. An uninterrupted and stable supply of power and of quality water. Centralized facilities for distilled water, hot water, liquid nitrogen, ice, dry ice, instrument repair, and the like. Internet connectivity. State-of-the-art communication facilities within the complex and with the city, the country and the outside world. Both tele- and video-conference facilities. Appropriately equipped conference rooms and lecture halls. Bank, travel, post office, school, shopping center, restaurants and residential complex. Clean toilets, parking and guest house facilities. Easy, reliable, frequent and comfortable transportation from the city. Common and efficient security and appropriate fire detection and fighting systems. Pleasant surroundings. PM Bhargava Pushpa M Bhargava is one of India's most brilliant scientists. He founded and directed the Centre for Cellular and Molecular Biology (CCMB), Hyderabad.His scientific contributions include the preparation and characterization of primary liver cell suspensions, identification of proteins from the seminal plasma and extensive characterization of one of these proteins and seminalplasmin. He has been awarded with Padma Bhushan, the Legion d' Honneur, the Wattumul Memorial Prize and Goyal Prize. ]]> <![CDATA[Bioinformatics red hot]]> https://biospectrumindia.com/news/95/2661/bioinformatics-red-hot.html https://biospectrumindia.com/news/95/2661/bioinformatics-red-hot.html Mon, 21 Jul 2003 21:28:00 +0530 The last decade was rightly termed as the information technology decade. It dramatically altered the way Indians live and dream. This period witnessed Indian entrepreneurial spirits soaring with the rise of the dotcom wave which unfortunately lasted for a short span. But the resilience of the IT professionals soon found outlets in bioinformaticsâ€”application of IT to the management of biological information. It has propelled many familiar names from IT industry to explore the field of bioinformatics. Some big players in India are doing more than take a mere look at the scenario. These days media has been seeing, almost on a daily basis, how the Indian infotech, biotech and pharma sectors are joining hands to explore the tremendous potential of this new area. Although India is expected to play a leading role in the bioinformatics revolution, it is widely recognized that we lack trained bioinformatics professional. At present a strong need is felt for a multi-disciplinary system of education which incorporates both these areasâ€”biology and computer science. Both universities and private institutions have started offering courses. Today, offline and online courses are available in the country. Take for example, Bioinformatics Institute of India (BII). It is engaged in providing education and training services in Bioinformatic sciences. According to Puneet Mehrotra, technical director of the institute, "The total number of students enrolled in BII's regular and distant learning programs has reached up to 5,000. The need for talented professionals is high and the institute is creating a complete pool for bioin-formatics. We tend to provide almost all sorts of services in this specific areas." As for the application of bioinformatics, within 10 years, all new drug designs will be genomics-related. Here is a $300 billion pharmaceutical industry and a very fast-growing biotech industry to support. There is a $300 billion industry spending, $30-40 billion a year in R&D: huge efforts, no tools. There are very good sequencers around, with good instruments, but there isn't very much software to support it. Jawaharlal Nehru University (JNU), New Delhi, is one of the early introducers of bioinformatics course in India. Prof. Alok Bhattacharya, dean, School of Life Sciences at JNU, shares some of his past experiences. "In the late Eighties, when we actually ventured into this field. The reaction from the industry was mixed. At that time, the use of computers had not reached to the top level, either. But, now the requirement of bioinformatics professionals has increased and it is the most emerging and efficient tool for research." Commenting on the number of students, he said, "We believe in a very selective human resource. We do not keep our focus to produce large number of computational biologists, because the industry is very selective about such workforce." His center would introduce MSc in Computational Biology from next year. "This name, Computational Biology, indicates a much larger canvas. Since the future lies in the hands of upcoming young talents, coming from combination of biology and computers, this new course will attract people from both the backgrounds," he added. The combination of biology and computers is understandable. But what about biotech and management? This is a very futuristic thinking. But we are not behind here. Looking at the future needs and opportunities in biotechnology, University of Pune has launched a two-year full-time MBA program in biotechnology (MBA Biotechnology) last year. This is not only the first such program by any Indian university/institute but also probably the first of its kind in Asia. Says Dr (Capt.) CM Chitale, professor and head of the department of management sciences, "We want to give the basic inputs for managing the biotechnology products, on intellectual property rights etc., which are key for the growth of biotechnology in India." Added Dr Smita S Singhania, lecturer and course co-ordinator (MBA-BT), "The biotech companies are eagerly looking at the department. They want to absorb the top five." The thrust on biotechnology education is scaling high. According to Dr MR Kurup, secretary, Kelkars Education Trust "The objective of the courses is to provide skills to the students for self-employment, to train students to suit to the industry requirements, to apply high technology in teaching and training and to establish industry â€“academic interface." Adds Dr SS Barve, head, department of botany and coordinator, department of biotechnology, in Pune University "All our students are working in well known organizations in India and other countries. This validates the point that there is ample demand for quality students in the biotechnology industry."Is bioinformatics very prospective?"A person needs to be a jack of all trades, and then he or she can become master of bioinformatics," Prof. K Kannan, dean, School of Biotechnology, Guru Gobind Singh Indraprastha University (GGSIPU) Prof. K Kannan started his career as a scientist at the Center for Cellular and Molecular Biology, Hyderabad. He has the corporate experience too. He had served as general manager and associate director of biotechnology at Ranbaxy Research Laboratories. He has been advising several industries about diversification into biotechnology as a consultant. He shared his perspective on the biotech opportunities with BioSpectrum. Excerpts: Is bioinformatics very prospective? In the next few years, the bioinformatics sector will definitely offer at least 7,500 job opportunities. This is because bioinformatics will act as an active tool for almost every segment of biotech research, whether its is drug discovery or even environmental research work. Its application can ease the burden of research work. At least bioinformatics can indicate the scientist about what is needed in their research and what is unnecessary to work on. I am sure that in the coming few years, this will be attractive to young people. Where are the opportunities? These opportunities will come from corporate houses, research institutes and academic institutes. For example, if you see the industry today, a lot of big companies are coming up in the field of biotech and bioinformatics. Big players in IT and pharma industries are showing good interest in this field, and this is the correct time for youngsters to move in to this industry. Development in this segment is taking place at a high speed. Shouldn't academia focus more on this subject? Yes, since it has a potential for growth and its industry is in need of specialized people. Biotech has been added in CBSE syllabus for class 12th. The students are also showing good interest in it. There are many educational institutes that have shown active interest in imparting the biotech and bioiformatics courses. What is necessary to be a good bio-informatian? It requires a computer background. It would be a plus point if someone has biology background as well. But, bioinformatics requires quite a fair amount of knowledge of statistics and mathematical calculations. So, in my view a person needs to be a jack of all trades and then he or she can become master of bioinformatics. What is the prime focus area in this field? Systems biology is an up coming term in the field of research. It is a handy tool in the research work. Although bioinformatics is itself one of the most unique dimensions of biotech field as it offers the customized solutions, its application in the research work made its progress faster and result-oriented. Will biotechnology replace chemistry in academics? Biotech is not replacing any subject, though it is true that the academic institutions are talking more about biotech rather than chemistry. PIONEERSBIC at Jawaharlal Nehru University, New Delhi The Bioinformatics Centre (BIC) at Jawaharlal Nehru University, New Delhi is among the pioneers of bioinformatics education in the nation. BIC was set up in 1989 funded under the Biotechnology Information Systems Programme (BTIS) of DBT. The center, which was functioning at the School of Computer Systems Sciences building from its inception in 1988, shifted to its present location in 1995. The centre is well equipped with all the necessary facilities in terms of hardware, software, networking, etc. BIC-JNU is offering one-year post MSc Diploma in Bioinformatics and PhD program in bioinformatics. Computational genomics is the thrust area of BIC. Bioinformatics Institute of India, Noida UP This institute is engaged in education and training services in bioinformatic sciences. It offers three PG Diploma courses via distance learning program to graduates, biologists, software professionals and professionals in other related fields. These courses are provided through local study centers in cheminformatics, bioinformatics and biomedical informatics all over the country. The total number of students enrolled in BII's regular and distant learning programs has reached up to 5,000. The courseware and methodologies of BII have been developed on par with international standards in consultation with industry experts and academicians. It plans to set up of a state-of-the-art development center to provide a world class R&D facility to budding scientists. The R&D areas of the organization are wide ranging from biotech to pharmaceuticals and medicine. The institute assists in technology outsourcing, identification of joint ventures and marketing tie-ups for various products and services of pharmaceutical and other product organizations. CBT at Anna University, Chennai The Center for Biotechnology (CBT) at Anna University, Chennai is one of the oldest biotech education institutions in the country. Started in 1987 with funds from the University Grants Commission, Department of Biotechnology and Anna Univesity, CBT has played a pioneering role in biotech education. In 1992, the center started a B Tech program in industrial biotechnology. It is supported by a large consortium of industries who have set up a corpus fund to the run the program. Recently, CBT got a boost with more funds donated by a well-known biotech company, Amersham Biosciences. Two more positions of lecturers were created using these funds. CBT also offers a two-year M Tech (biotech) and PhD programs in biotechnology. Students are admitted through an entrance examination. Anna University is the largest Technology University in the country with 222 engineering colleges in Tamil Nadu affiliated to it. Center for DNA Fingerprinting and Diagnostics This is an autonomous institution supported by the Department of Biotechnology (DBT). It is India's premier center providing services in the areas of DNA fingerprinting, molecular diagnostics, and bioinformatics. CDFD is now poised to initiate basic research in fields relevant to its objectives. CDFD is also the bioinformatics national node for the European Molecular Biology network (EMBnet). The node currently provides bioinformatics services in the form of browsing biomolecular sequence databanks, macromolecular structure databank, genome and other useful databases. Indraprastha University, Delhi Guru Gobind Singh Indraprastha University (GGSIU) is offering BTech course in bioinformatics. It has some unique features in its course curriculum. This special academic program is a result of successful alliance between School of Information Technology and School of Biotechnology at GGSIU. The four-year B Tech program in Bioinformatics was first started in 1999 with 30 students. Recently, a fourth year student of School of Biotechnology, Amit Aggarwal, was selected for the PhD program in neuro sciences at Cottingham University, Germany. The university is also offering an integrated five-and-half year M Tech program in biotechnology. University of Pune (MBA Biotechnology) University of Pune has taken a path-breaking initiative to catalyze the biotechnology revolution. It has launched a two-year full-time MBA program in biotechnology in the academic year 2002-03. This is the first such program by any Indian university or institute. This is probably the first in Asia too. The course has been envisaged to create managers with domain specific knowledge for the biotech industry. The syllabus is based on the requirements of the industry. Sixty percent of the syllabus covers the managerial aspects and 40 percent biotechnology. The institute received overwhelming response for the course during the first year. The program admits 60 students each year. There will be a provision to admit international students also. The fee per year is Rs 18,500. VG Vaze college, Mumbai Kelkar Education Trust's VG Vaze College offers degree-level courses in biotechnology. The college has a state-of-the-art biotechnology lab and a scientific research center. The center under takes research in areas relating to medical, aromatics, cosmetics and environmental biotechnology. DST and University of Mumbai have bestowed the center as a recognized institution for research. Students will be admitted at the center for MSc (by research) and PhD in life sciences. The center is focusing on the development and mass propagation of medicinal and aromatic plants. The college, in collaboration with the research center and industry, has plans to offer certificate and diploma courses and training in perfumery, cosmetics, horticulture and tissue culture techniques, agricultural applications, etc. These courses are expected to commence from this academic year 2003-04. They will be offered to the science stream students. These diploma courses will be simultaneously offered to the students pursuing other degree courses too. Rai University, Bangalore Founded by Rai Foundation, this group has spread its educational arms across the nation with campuses in Bangalore, Behror, Bhopal, Dehradun, Gurgaon, Hyderabad, Kolkatta, Kosi, Lucknow, Mumbai, New Delhi, Pathankot and Pune. It is offering BSc in biotechnology, BSc( Hons) in environment management studies, Graduate Diploma (Hons) in biotechnology and patent laws and GPD (Hon) in forensic sciences. It also offers post graduate diploma in bioinformatics and in industrial microbiology. RGCB, Kerala Rajiv Gandhi Centre for Biotechnology ( RGCB ) is an autonomous research institute that functions under the umbrella of Science, Technology and Environment department of the Government of Kerala. Established in its present form in 1994, RGCB has come to occupy an important position among the research institutes of the country devoted to research in the cutting edge areas of modern biology and biotechnology. It occupied a new building in January 2002. With the support of the DBT it has established research facilities required for carrying out modern biological research. Currently, the research activities are being carried out in seven major divisions: infectious diseases, plant molecular biology, environmental biotechnology, molecular human genetics, neurobiology, cancer biology and molecular endocrinology. New Institutes East West Institute of Technology Recognized by the Government of Karnataka, affiliated to Vishwe-shwaraiah Technological University and approved by All India Council for Technical Education (AICTE), New Delhi, the East-West institutions have been functioning in Bangalore for over three decades catering to the needs of quality and integrated system of education. All the institutions are having their own buildings and are centrally located. The East West Educational institutions have earned very good reputation for providing meaningful education and for maintaining high standardsâ€”both in professional and nonprofessional courses. East West offers Bachelor of Engineering courses in biotechnology engineering. This is an eight-semester course, affiliated to Vishweshwaraiah Technological University. It also offers graduate and postgraduate courses in biotechnology. Edubiotech Edubiotech is a technology driven organization, providing world-class biotech technical support to educational institutions and corporate sectors. Edubiotech accelerates innovative ideas by providing good quality R&D and lab facilities. Each one has a place and is given the opportunity to excel in their field of interest. Oxford Group, Bangalore The Oxford Group of Educational Institutions is a group that yearns at strengthening the concept of value based education. There are 22 educational institutions in all the branches of this institution. The Group has a separate College of Engineering as well as a college of Science in Bangalore. Today the Group is offering engineering as well as graduate and postgraduate programs in biotechnology. The Oxford College of Engineering is affiliated to Vishweshwaraiah Technological University and approved by AICTE, New Delhi and offers four-year BE in biotechnology engineering. The Oxford College of Science offers BSc in biotechnology and related fields such as microbiology, genetics and biochemistry. It also offers postgraduate courses in microbiology, biotechnology, and biochemistry. Padmashree Institute, Bangalore Padmashree Institute of Information Science (PIIS), affiliated to Bangalore University, is offering courses in Biotechnology at both undergraduate and postgraduate levels. The biotech program at the institute has been designed to bridge the gap between industry requirements and the growing demand for skilled manpower in the sector. The institute also offers services to the industry. The areas include protocol development for micro-propogation of ornamental and medical plants, maintenance of mother cultures, supply of planting material for cultivation, testing of microbial activity, testing microbial load in food cosmetics, drugs and extracts and also it has the provision of services for research fellows in the areas of plant tissue culture, biochemistry, microbiology and diagnostics. RK Institute of Management and Computer Science RK Institute of Management and Computer Science, recognized by the Government of Karnataka, affiliated to Bangalore University and approved by AICTE is offering courses in biotechnology at both under graduate and post graduate levels. The institute has a highly sophisticated research lab. The lab meets the requirements of the Bangalore University curriculum. The labs are well equipped with air conditioned tissue culture chamber and advanced models of laminar flow bench, UV-Vis Spectro photometer, incubators, autoclave, microscopes, electrophoretic units, optical instruments charts, models and other useful instrument to impart and enhance the practical aspects. Such progressive instruments and equipment contribute to the richness and variety of the courses offered by the institute. STG Software Technology Group (STG) is a technology driven company established in 1993 in San Jose, California, providing world class software consulting and training solutions to organizations and professionals in several countries. STG is a leading provider of advanced software education and has strategic alliance with IBM, Microsoft, Red Hat and Sun Microsystems amongst others. STG trains thousands of professionals each year on leading edge technologies. Bioinformatics becoming an increasingly important competitive differentiator for public and private life science companies, STG entered into this emerging field to provide extensive and expert training. Bioinformatics @STG is structured and designed to meet the industry's requirements and has collaborated with several institutions and research organizations to value add to its students. Live projects are provided and there will be an opportunity for the students to work in the horticulture department laboratory under the guidance of professors and research scientists at UAS. Wageningen, Bangalore Europe's premier institution, Wageningen University, recently launched its educational module for biotechnology in Bangalore for the first time. Wageningen University in the Netherlands was established in 1918 and had over 10,000 students emerging from its portals annually. As one of the leading centers of education and research in plant, animal, environmental, agro-technological, food and social sciences, Wageningen had been offering quality programs in Asia. The mission statement of the university is to develop and disseminate scientific knowledge needed to sustain and supply society's demands for sufficient healthy food and a good environment for humans, animals, and plants. Wageningen had tied up with two service providers in Indiaâ€”Bioinfraa and C-Lift, both Bangalore-based companies. SS Infotech, Bangalore SS Infotech started in the year 1999 as a non-profitable organization to provide high quality education to less fortunate students at an economical cost. Started with MSc (IT), BSc (IT), MBA and BBA courses, presently it is offering one year PG diploma in bioinformatics through Bioinformatics Institute of India, Noida. The objective of the course is to provide adequate knowledge and training to the student with hands on experience in the field of bio-informatics. The institute has developed a course keeping in mind the requirements of the industries and to equip the students with the latest advances in the field of bioinformatics. The institute also offers correspondence courses in biomedical-informatics, bioinformatics and cheminformatics. Biotech Education Services &Training (BEST), Bangalore BEST was started as a company incorporated to undertake activities in imparting quality research and training in biotechnology. The objective of BEST is to promote quality hands on training program in biotech education. Besides training the company has successfully forged into contract research services, protocol development, water analysis and waster water management. BEST is equipped with state of art facilities, competent and dedicated technical manpower. Its network has helps the students in placements and career counseling. It offers one-year PG diploma, short-term course of 10-50 days and advanced diploma courses of three months duration in biotechnology. ]]> <![CDATA[Dendreon raises $27 million to develop cancer vaccine]]> https://biospectrumindia.com/news/95/2806/dendreon-raises-27-million-to-develop-cancer-vaccine.html https://biospectrumindia.com/news/95/2806/dendreon-raises-27-million-to-develop-cancer-vaccine.html Mon, 21 Jul 2003 21:21:00 +0530 Seattle-based Dendreon Corp. has raised $26.7 million through the sale of 3.8 million shares of Dendreon common stock to three key investors. The company plans to use the funds to speed up the development of a vaccine against cancer. A company statement said the shares were sold at $7 each to Baystar Capital, Mazama Capital Management and to an existing company shareholder. Bulk of the funds would be used in the development of Provenge, its lead investigational cancer vaccine for the treatment of androgen independent prostate cancer. Some of the funds may be used for general working capital purposes. The drug recently got a part approval from the regulator, the Federal Drug Authority (FDA), which gave Dendreon a Special Protocol Assessment. This indicates that the company"s pivotal phase 3 trial, D9902B, for Provenge will serve as the basis for a Biologics License Application for potential approval of the product. "Raising this capital will enable us to augment our scale-up and commercialization plans for Provenge and expand the development of some of our exciting and promising early stage product candidates," said Dendreon"s CEO Mitchell H Gold in a press release. "As we finalize the acquisition of Corvas International, this financing will allow us to invest in the promising product portfolio of the combined company. We remain committed to completing the Corvas acquisition as quickly as possible." Provenge is Dendreon"s investigational therapeutic cancer vaccine designed to stimulate a person"s immune system against prostate cancer. A double blind, placebo controlled phase 3 trial of Provenge, D9902B, is underway and is recruiting men with androgen independent prostate cancer with a Gleason score of seven or below. The company claims that results of a completed Phase 3 trial of Provenge, D9901, has demonstrated significant benefit from Provenge treatment for men with a Gleason score of seven or less in delaying both time to disease progression and the development of disease-related pain. Recently announced results from the D9901 trial also demonstrated that Provenge treatment induced a significant T-cell mediated immune response. Dendreon Corp. is a biotechnology company developing targeted therapies for cancer. In addition to its therapeutic vaccines in clinical and pre-clinical development for a variety of cancers, Dendreon"s product pipeline includes monoclonal antibody and small molecule product candidates. It has established important research and development alliances with industry leaders, Genentech and Kirin Brewery Co. Conjuchem to raise $12 million for trial of diabetes drug Canadian drug maker, Conjuchem Inc., plans to raise $12 million through private placement to fund the clinical trials of its diabetes compound DAC: GLP-1, which recently got the US drug regulator"s approval for such trials. The Toronto-based company said a syndicate led by Yorkton Securities would buy 6.25 million of its common shares at $1.60 each. The group has an option to buy a further 1.25 million shares which, if exercised, would result in gross proceeds of $12 million, according to a Reuters report. ConjuChem"s shares have risen more than 200 percent since early May when the company announced that it had received clearance from the US Food and Drug Administration to begin US clinical trials for its AC:GLP-1 compound, used for the treatment of Type 2 diabetes. The company expects to report top-line preliminary data from the US study in September and preliminary results from its European study in June. Can-Fite raises another $12 million Israeli biotech company, Can-Fite BioPharma has comp-leted a year-long fund raising drive by raising $12 million from various investors. The last investment of $500,000 was made by BPW Israel Ventures LLD, a private equity fund managed by Bassini Playfair Wright LLC. Can-Fite is developing many innovative treatments for cancer and inflammatory diseases. Other contributors in this round included Giza Venture Capital, The Yozma Group, Ascend Technology Ventures, Vitaife and some senior physicians. The BPW funding, in particular, was earmarked to help support the current Phase II clinical trials of CF101, including that for the treatment of colorectal cancer. Candidates for participation in this study are now being enrolled at four leading medical centers in Israel. "BPW Israel Ventures is extremely pleased to be an investor in Can-Fite, as we believe the company"s unique approach has the potential to revolutionize the treatment of cancer and other diseases," said Emilio Bassini, co-founder and managing principal of Bassini Playfair Wright LLC, a New York-based private equity firm that focused on emerging markets. BPW Israel Ventures LLC was established in 2000 to make fund and direct investments in Israel-related companies active in the technology sector. Bassini Playfair Wright LLC manages assets totaling approximately $600 million. "This is an exciting time for Can-Fite. First, we are delighted to be working with the prestigious and distinguished team at BPW," said Dr Ilan Cohn, can-fite bioPharma President and CEO. "We are also enthusiastic about the start of our Phase II trial. Patients having advanced metastatic colore-ctal cancer are eligible for enrollment in this trial. Based on the pre-clinical and clinical data to date, we are optimistic that this study will produce promising results." The trials aim to determine the safety and preliminary efficacy of daily oral doses of CF101 as a third-line monotherapy for patients with metastatic colorectal cancer. Nearly one million people worldwide are diagnosed with this cancer annually. Can-Fite is a privately held company headquartered in Petach Tikva, Israel that began operations in year 2000. The company was founded by Prof. Pnina Fishman, a tumor immunologist from the Rabin Medical Center in Israel, who serves as the company"s chief scientific officer and by Dr Ilan Cohn, the company"s president and CEO, based on Prof. Fishman"s scientific work. Can-Fite"s research is conducted in its research lab in Israel. The company also has a US-based senior management team that is involved in its pre-clinical and clinical development. Can-Fite is currently engaged in Phase II trials of its lead drug CF101 for the treatment of cancer and rheumatoid arthritis and in research and development of its rich pipeline of drugs and clinical indications. The market potential for CF101is estimated at more than $1 billion worldwide. The first commercial product is expected in 2006. Investors in the company include Giza Venture Capital, The Yozma Group, Ascend Technology Ventures, Vitaife, Biocom BioMedical Inno-vations Management and PBW Israel Investment LLC. ]]> <![CDATA[Biotech crusader]]> https://biospectrumindia.com/news/95/1608/biotech-crusader.html https://biospectrumindia.com/news/95/1608/biotech-crusader.html Mon, 21 Jul 2003 21:14:00 +0530 Vivek Singhal is one among the few entrepreneurs who has been successful in both the IT and biotech industries. He ventured into the IT business as early as 1974, starting Computeronics India Ltd. Two decades later, he forayed into the biotech industry founding Biotech International Ltd. He is also the founder president of All India Biotech Association (AIBA) and has taken the lead to champion the cause of the biotech industry. Way back in 1993, he ventured into the biotech industry with the launch of Biotech International Ltd (BIL). His vision was to propel "Tomorrow's Bharat". That was the time when the IT industry was advancing towards a big boom. He had the know-how of the IT industry's success and wanted to replicate it in the biotech industry. His active sojourn into biotech started in 1992, when he made a presentation to the Department of Agriculture & Cooperation, Govt. of India, which invited 28 top scientists in the country involved in biological control. His presentation highlighted the need to produce eco-friendly biopesticides and biocontrol agents on a large-scale, as substitution/supplement to chemical pesticides. He didn't look back thereafter. Singhal played a key role in making the Integrated Pest Management (IPM) concept initiated by the Government of India a reality. It was a big challenge as various state departments of agriculture and farmers all alike needed to be convinced on the usage of bio-pesticides in place of chemical pesticides. Singhal and the senior officials of the Dept. of Agriculture, Govt. of India, organized several seminars and workshops on regular basis to promote the IPM programme. Within a span of two-three years, almost all the state governments started promoting IPM on a high priority basis. Consequently, most of the big states showed a 20 percent drop in use of chemical pesticides by 1998. Under his stewardship, BIL established insectories for mechanized rearing of parasites and predators in India. He has motivated the development of technologies and formulations of new microbial/botanical biopesticides and biocontrol products for control of vectors, pests and pathogens. BIL started a small Biocontrol Lab in Bangalore and is setting up another complex with an estimated investment of Rs 10 crore near Delhi for production of egg parasite Trichogramma, predator Chrysoperla and Nuclear Polyhedrosis Virus-based biopesticides. It is also setting up R&D unit to develop biopharmaceutical and therapeutic products to address cancer, cardiovascular disorders and viral infections. This R&D unit shall also be involved in tissue culture for transplantation and development of vaccines against malaria, tuberculosis and other tropical diseases. Singhal is a strong advocate of healthy associations and he actively pursues the cause of the industry with the government and the industry bodies like FICCI, CII, and ASSOCHAM. He stresses the need to actively collaborate to work towards the propagation and induction of new processes and techniques developed by research organizations within the country by the industrial units in India. And he wields a strong influence, as he has been tirelessly campaigning for years for emerging sectors. He holds several key positions like chairman (N) of Federation of Indian Exports Organization (FIEO), member of the governing council of CSIR, besides being president of AIBA. He was also the chairman of Electronics & Computer Software Export Promotion Council (ESC), among other key posts. Laurels have followed his work. He is the recipient of Shri BD Jatti, Shri Giani Zail Singh, and Dr Sanjeeva Reddy Awards for "outstanding performance in export and social service." He was also honoured with a special award for bringing computer usage consciousness in India" by former prime minister, Rajiv Gandhi. He also won the award for "best export performance in IT-related area 1999-2000" from prime minister, Atal Behari Vajpayee. The next step forward for Singhal is enabling SMEs to contribute. Singhal tells, "To make biotech a big success, the industry should motivate new and small businesses. Big players of the BT industry should have to work in accordance to promote this segment of the industry. To grow this emerging industry, growth of small entrepreneurs is vital." He draws a parallel from the IT sector. "To make biotech a big success, the industry should motivate new and small businesses" In an exclusive interview, Vivek Singhal shares his experiences and views with BioSpectrum. What was the reaction when you ventured into biotech in 1993? That was the time when people were asking me why I chose a different field from IT. In fact, the IT industry too was not that big a success in India at that time. The IT boom had stuck. In that period, I was establishing BIL into biotech. I had mixed reactions from my friends. But now people are getting attracted towards biotech industry. Now you have a list of IT majors coming into the biotech or planning to come into it. Which areas of biotech industry does BIL target? How competitive are BIL products with international standards? What are your future plans? We incorporated BIL in January 1993, with an ingenious mandate for "In Harmony With Nature". Targeting the agriculture and public health sectors, the company deals in ecologically safe biotechnology-based products. BIL is the sole company in India having "Biological Input Umbrella" for agriculture and health sectors. Our products compete with international standards and have been established for their efficacy on various pests and vectors prevalent in India. They have been evaluated for toxicology under Indian conditions and eight of our products have obtained registration from the Central Insecticides Board, Government of India. Apart from India, our products have been tested and proved to be amongst the best in Africa, the Middle East, South East Asia, Australia and Europe. We wish to enter the health-care segment with products like diagnostics, vaccines, therapeutic biomolecules and herbal medicines. We are currently involved in the development of high quality, efficient and crop non-specific biofertilizers with multiple crops benefiting characteristics. What is the major cause for the adverse scenario of the Indian farmers and agri-industry? Losses due to pests and diseases in the agriculture production account for losses to a tune of Rs 90,000 crore. Moreover, agricultural commodities worth Rs 4,000 crore get rejected by the foreign buyers on account of presence of chemical pesticide residues. Further, there have been cases of numerous suicide deaths by farmers, who have come under heavy burden of debts for procurement of agricultural inputs, including chemical pesticides, which are no longer effective in the control of the dreaded pests and diseases. This leads to pests becoming increasingly resistant to pesticides. In addition, it is a known fact that chemical pesticides have ill- effect on human beings causing dreaded diseases like central nervous system disorders, cancers and reproductive dysfunction. It was these facts that made me to introduce the use of bio-pesticides on a large-scale commercial basis in India. What are the basic roles and objectives of AIBA? The objective of AIBA is to promote and safeguard the overall interests of biotechnology as a science, profession, industry or trade. Collection of all information on matters affecting the members is also a part of the association. We make representations to the various authorities in the interest and betterment of the constituent members. The main idea behind its formation is to cooperate with other individuals, associations, groups and bodies within the country and abroad having similar aims and objectives. AIBA also encourages and gives its support to any association or Government Policy for the improvement of laws relating to biotechnology. What has been AIBA's contribution to the Indian biotech Industry? The basic idea of forming AIBA is liaison between the biotech industry and the government. AIBA helps the industry in taking up its problems to the government and solving the same and thereby promoting biotechnology in the country. In 1998, AIBA opened its Southern Chapter in Hyderabad to cater to the needs of the southern states and initiated the starting of the biotechnology park and biotechnology council. The Northern chapter was opened in 2000 in Chandigarh and the Western Chapter in 2001 in Gujarat. The contributions of AIBA to the industry include organizing international seminars/conferences and exhibitions in this hi-tech area. The Southern and Western Chapters of AIBA are facilitating alliances between the SMEs and foreign collaborators. Last year, joint ventures worth Rs 100 crore were established. Recently, AIBA initiated formation of Biotech Export Promotion Forum approved by the Government of India. What are the future prospects of biotech industry in India? We have seen a good growth in recent times in conventional biotechnology. This includes vaccines, diagnostics and antibiotics in the health care area, hybrid seeds, tissue culture etc. The rest comes under the industrial product area such as alcohol, citric acid, lactic acid and glucose from starch, cheese, penicillin acylase. There are certain specialized areas like production of restriction endonucleases, oligonucleotides, culture media, plastic wares, automatic pipettes, and microtips. The modern biotech product areas are also gaining momentum. Consumption of biotech products in India was to the tune of Rs 7,154 crore during 1997 and that demand by 2005 is estimated to go up to Rs 14587 crore. In 1997, about 72 percent of the biotech product consumption was met through local production itself. At present, there are about 110 units in health care products, 140 units in the agriculture and about 300 in the industrial and other biotech products in India. To make biotech a big success the industry should motivate new and small businesses. Big Players of the BT Industry should have to work accordingly to promote this segment of the industry. To grow this emerging industry, growth of small entrepreneurs is vital. IT industry in India has witnessed a good growth of small companies. It was the small enterprises which made the IT boom. Same sort of involvement from small or medium enterprises is also needed for the biotech industry, to post another successful impact on Indian economy. A common belief is that the yield using chemical fertilizers is more than that by biofertilizers. Is it so? It is true that chemical fertilizers on one side give us higher yields through fertility of our soil. Switching over to nature, biofertilizers, gives us equally good results, if not better. About 85 percent of our agricultural land depends on rain water. Chemical fertilizers cannot be used on that. Therefore, biofertilizers have a great importance. At present, the country needs 50,000-60,000 tonnes of high quality biofertilizers. We hardly produce around 5,000 tonnes. Also they are not up to the standards. Right type of sterilized carrier using radiation technology can give high quality product. Most of the biofertilizers available today have a shelf life averaging not more than four-six months. By the time the product reaches farmers it is about two-four months and the product does not remain effective. This is one of the reasons why biofertilizers is not catching up in our country, whereas, in Europe, the US and Australia, it is becoming extremely popular. What is the future of biopesticides and biofertilizers? The future is looking great. But the rate of awareness needs to grow at a rapid speed. Opportunities for investment in this sector are likely to increase substantially in the coming years as the products are being established in the country's agricultural activities. We can expect fresh investments worth Rs 80 crore in the production of biopesticides and other bio-control agents over the next five years. In the biofertilizers category, the consumption of rhizobium biofertilizers in India may rise to 8,000-10,000 ton per annum over the next five years. The use of biofertilizers is expected to increase substantially. The investment opportunity for biofertilizers production is expected to be over Rs 200 million over the next five years. Which are the areas that the Indian biotech industry lags behind on a global comparison? Unfortunately, we have lot of areas like that. But we are not working on thoseâ€”such as tissue culture and flowery culture. But we are exploring these areas and catching up with the world market. At present, the plant tissue culture activities are confined to production of ornamental and flowering plants in India. More units are likely to be set up. As demand for flowers is increasing, India is taking greater interest to develop this field. Faiz Askari ]]> <![CDATA[Transgenic supporter]]> https://biospectrumindia.com/news/95/3090/transgenic-supporter.html https://biospectrumindia.com/news/95/3090/transgenic-supporter.html Mon, 21 Jul 2003 21:12:00 +0530 There are not too many people who know more about Genetically Modified (GM) products than Dr Shivramiah (Shanthu) Shantharam. For, in 1986, as a director at the US Department of Agriculture (USDA), he supervised the field trials of the world's first GM tobacco variety. The tobacco did not have a full-fledged external gene introduced in it but carried a marker gene. And this was considered to be the beginning of the advent of GM crops. The trials were conducted at the North Carolina University, Raleigh, and he wrote the first environment impact assessment of the product. During his 12-year stint at USDA, he had supervised over 5,000 field trials of various GM crops. Some 15 GM food products are now in the US market. Shantharam had played a key role in developing the regulatory policy for transgenic crops and micro-organisms for field testing and commercialization in the US. A molecular biologist by training, Shatharam has been handling the external outreach program of one of the world's leading bioagri companies, Syngenta, from Basel, Switzerland. From July, he is pursuing his entrepreneurial dreams by starting a biotech consultancy, Biologistics from Washington DC. Before joining Syngenta, he was Visiting Research Fellow at the well-known International Food Policy Research Institute (IFPRI), Washington DC. There he estimated the costs of regulation and regulatory policies on biotech product development and technology transfer. He has also conducted extensive research on the impact of crop biotechnology on subsistence and poor farmers in developing countries. Another important work of his relates to biotechnology assessment to identify useful technology for adoption by farmers in developing countries. A powerful speaker, Shantharam is a regular participant at leading biotechnology conferences around the world. He had lent his expertise to several biotech projects. Notable among these were the inputs as a technical resource person on the steering committee of the Asian Rice Biotech Network and the Agriculture Biotech for Sustainable Productivity (ABSP) for over a decade. Shantharam continues to play an active role in ensuring harmonization of biotech policies and supports several biotech regulatory capacity building activities in developing countries. N Suresh "India's GMO policy is shaped by three activists" Shantharam shared with biotech enthusiasts his concerns over the impact of current regulatory policies on GM products at a meeting of the Foundation for Biotechnology Awareness and Education (FBAE) in Bangalore in June during a visit to the city to see his mother. Excerpts: Are the apprehensions about the safety of GM foods justified? There is no shred of evidence to believe that Genetically Modified (GM) crops were any more dangerous than any other crop introduced in the market for centuries. The European Union (EU) has spent over $65 million (Rs 325 crore) in 15 years to study the impact of GM products. And it has given a clean chit to GM products. Over 70 to 80 percent of the food items consumed in the US contain Genetically Modified Organisms (GMOs). Nearly 350 million Americans are the guinea pigs who have been consuming these products for 15 years. Yet there is not a single case of adverse reaction reported due to GM foods. What more evidence do you need about its safety? Then why is there a lot of opposition to these products? It is not the hard core data which is available about these products which people are very critical. Critical assessments based on scientific data are fine. But there are people, especially the die-hard opponents of GMOs among the NGOs who refuse to accept the scientific evidence. If you ignore the data just to stick to your point of view, there is no end to this debate. You have played a key role in evolving the regulatory framework for GM products in the US. How are the regulators around world responding to GM products? To satisfy the unscien-tific demands of these opponents, the regu-latory systems all over the world have become rigid and hence very expen-sive. According to a study done by the International Food Policy Research Institute (IFPRI), Washington DC, the average cost for complying with the regulatory requirement for a single GM product is $5-6 million (Rs 25-30 crore) in the US. And because of the unofficial moratorium on GM products practiced by the European regulators in the last seven years, the cost for dealing with the regulator is $9-12 million (Rs 45-60 crore). Imagine how much unnecessary costs are incurred just to satisfy these mindless critics. There have been several controversies about GM products. What is their status now? Almost all the controversies related to GMOs have been blown up beyond proportions. Take for instance, the celebrated case where the Bt corn was found to be a threat to the Monarch butterfly in the US. Cornell University researchers who highlighted it first had actually erred. After three-and-half years of research, spending some $6 million (Rs 30 crore), USDA was able to prove that the Bt corn crop did not affect the butterfly population. In the StarLink corn case too, similar thing happened. Some researchers while evaluating simulated data found 30 percent of the product had traits similar to some allergy-causing substances. It turned out from actual data that the simulated results were an aberration and it did not occur in real products. Meanwhile, the company suffered losses over $1 billion. The company itself does not exist, as it had to be sold to the Bayer group. In the recent case involving Pioneer Seeds which is part of DuPont, the $80 million fine was for a minor technical violation. How can the technology overcome such hurdles? It is a pity that the silent majority of people who know more about this topic, that is the scientific community, do not speak out. Because, they don't really care about this debate. It is time at least students of agriculture raise the scientific issues and counter the anti-GM lobby. There is no point in worrying about your college seats or jobs. If there has to be jobs in the future in this sector, GM technology has to be accepted. Because, without GM technology, there will not be much progress in agriculture in the future. What will be the impact of this in the long run? Politicization has brought this technology to a standstill. If the European Union doesn't change its decision on GM crops, this technology is not going to reach Asian and African countries where it is needed urgently to improve crop productivity. Even India is going to suffer. India doesn't allow import of GM products. What is the basis for this decision? Critics say it is not tested enough. But look at the conventional plant breeding process. It is a mysterious process. Hundreds of genes from one set of plants are transferred to other plants. The breeders have absolutely no clue about the gene transfer. At least with the GM technology, you are in control of the gene that is transferred to a plant. Another fear is that genes will escape into the environment. Genes have been escaping into the environment for ages. So do the pollens. How is it any different with GM crops? In fact, it may be actually beneficial if the pest resistance characteristics are transferred to other plants. The positive effects of GM technologies are well known. Still why is the regulatory authority in India going slow on this issue? The rules for GM products are now set by the activists. Not by scientists, not by experts, not by policy makers, not by the government. They are always ahead of the other players in this game. The other people are not able to counter these activists. The strength of these activists is the high "trust factor" people have for them. According to a recent study by the World Trade Organization, majority of the people have more faith in NGOs than in their regulators, governments, scientists and companies. Can agri biotech companies afford to wait for a long time for the disposal of their applications? Governments across the world are promoting biotechnology in a big way. In India too this is happening. The governments are providing fiscal incentives, building biotechnology parks and several other facilities. But the governments should address the basic issue of acceptance of the GM technology. Otherwise, the investments will not take place. For companies, it is an uphill task to change the negative perceptions about this technology. It is a major public relations task. No other technology in modern times has faced so much opposition. The governments have to make the investments in this technology worthwhile. Take the case of the Council for Biotechnology Education in the US. It is spending some $60 million to educate the people about GM products. This money should be actually spent on further improving GM products to benefit more people. In India, the protest is based on issues which are being raised in Europe. There is not a single indigenous issue over which the protest against GM products is organized. The public policy on GMOs in India is shaped by just three individual activists. Isn't this a shame? ]]> <![CDATA[MiniPERM from Sartorius]]> https://biospectrumindia.com/news/95/1998/miniperm-from-sartorius.html https://biospectrumindia.com/news/95/1998/miniperm-from-sartorius.html Mon, 21 Jul 2003 21:10:00 +0530 MiniPERM is an easy-to-use bioreactor, which simplifies the high-density cultivation of hybridoma and other cell types, and enables cost efficient production of antibodies and other desired extra-cellular products in volumes ideal for screening purposes. Sartorius India supplies this product. MiniPERM is an alternative to static culture, roller-bottles and fermenter systems and is appropriate for use in a wide spectrum of research and laboratory applications. In addition to cultivation of hybridoma for antibody production and transfected cells for specific protein production, it is also applicable for virus production and general proliferation of biomass. Depending on the cells used, cell densities greater than 107 cells/ml and product concentrations of several mg/ml can be achieved. Special adaptation of culture techniques is not necessary. MiniPERM is suitable for serum-containing and serum-free culture. For more information, contact: Biju Jacob, biju.jacob@sartorius-india.com Axygen launches Maxymum Recovery Axygen Scientific USA, a manufacturer of laboratory disposable plastics for the scientific research market has now launched its Maxymum Recovery brand which offers researchers new heights in sample delivery and recovery. This offers a measurable advantage over conventional polypropylene. The wall surfaces of Axygen Maxymum Recovery products are free of occlusions and cavities. These products virtually eliminate fluid retention during sample aspiration and dispensing. In Maxymum Recovery, no secondary chemicals such as silicone or other substances are added. The company claims that Maximum Recovery products are certified to be safe from RNase, DNase and endotoxins. It can transfer the maximum volume of enzymes or DNA during testing procedures. For more details, contact: Navneet Trehan, axygen@vsnl.com. Bry Air brings out Ecoscrub Ecoscrub is an air and gas purification system. It prevents the damage of electronic and computerized controls due to corrosion by contaminating process air. It also helps to control odour and protects personnel working in areas where contaminating air is generated by the process. Ecoscrub performs both predictive and preventive maintenance, so it decreases the machine downtime and increase productivity. Ecoscrub is manufactured by Bry Air, an ISO 9001:2000&140001 company based in Gurgaon, dealing in dehumidification and air treatment, and is marketed and services by Arctic India Sales. For further details, contact: enquire@pahwa.com, ]]> <![CDATA[Nitin Deshmukh joins as D-G of ABLE]]> https://biospectrumindia.com/news/95/1062/nitin-deshmukh-joins-as-d-g-of-able.html https://biospectrumindia.com/news/95/1062/nitin-deshmukh-joins-as-d-g-of-able.html Mon, 21 Jul 2003 21:08:00 +0530 Nitin Deshmukh will be the public face of the biotech industry association, ABLE. Deshmukh has taken over as the first Director-General of ABLE (the newly formed Association of Biotechnology Led Enterprises). He will hold this position in addition to his existing responsibilities as Director of a US based Venture Capital Fund, shortly launching its operations in India. Deshmukh was until recently, Director, Private Equity at Dresdner Kleinwort Capital. Prior to this, he served as chief of private equity investment at ICICI Ventures. During his 13 years of private equity investment experience, Deshmukh has been involved with several investments in the life science sectorâ€”Sun Pharmaceuticals, Morepen Laboratories, Medicorp, Newland Laboratories, Ajanta Pharma and Intas Pharmaceuticals in the Pharma sector and Avesthagen, Advanced Biochemicals, Biocon, Bangalore Genei and Syngene in the biotechnology segment. Prior to his association with private equity banking, Deshmukh had spent four years with CIPLA in various technical and management positions. A few days after taking up the new job, Deshmukh shared his future plans with BioSpectrum's Executive Editor N Suresh. Which are the priority issues that will be taken by ABLE immediately? ABLE intends to work as a policy group to interact and partner with the government and policy makers to determine policies that would help the growth of the industry. The priority issues before us are intellectual property rights (IPR), regulatory affairs and encouraging investments all of which we believe are critical to creating the right image for the sector. What are your plans to get ABLE off the ground quickly with national presence? ABLE has just had its first meeting. We have initiated steps to drive the membership at the national level so that there is active participation in our various policy groups and activities from across the country. The formation of the Executive council is now complete where we now have the President-Kiran Mazumdar Shaw, four regional vice presidents- Varaprasad Reddy (south), Rajesh Jain (north),Raju Barwale (west) and Dr Anil Ghosh (east). We have regional co-ordinators identified for various cities/regions who would drive the interests of ABLE in these various regions along with the VPs. The association's General Secretary is Prof. Vijay Chandru and the treasurer is Dr Villoo Morawala-Patell. Similarly we have additional members of the executive council co-opted from different parts of the country. We have also formed special interest group committees for agri biotech (Dr KK Narayanan), pharma biotech (Dr Krishna Ella), industrial biotech (Dr P Babu), research services (Dr Swaminathan Subramaniam) and bioinformatics (Dr Pravin Kini), all headed by experts and having special invitees again from different regions of the country. ABLE is modeled along NASSCOM, the software industry association. How do you intend to acquire similar profile for ABLE in the shortest possible time? Well we certainly have NASSCOM as our role model. Interestingly, but for the size, the biotech sector is in a similar state of affairs vis-a vis issues as was the software sector in the late eighties when NASSCOM was formed in 1990. So in a sense ABLE formation is timely. We now have the challenge to put together the right building blocks whether they are in terms of getting the entire biotech community on board, identifying the right measures to determine progress or determining the roadmap for growth. Given the vastness of the sector and the complexities this is a huge task and the next three years would be critical to laying the foundation of ABLE. How many members are you targeting to enroll in ABLE? Any wish list? As I mentioned earlier, we have the executive council in place which has a national face and we have our immediate task cut out for a membership drive which will also help us to put together a good database eventually. We expect to have at least 75 percent of the biotech companies in the country on board by March 2004. Apart from that we are also targeting for associate membership from the biotech support community which would include all the associated technology players, biotech equipment manufacturers, the investors, executive research firms, consulting firms and the research institutions. We therefore expect to have a very healthy membership in the next 12 months. Personally, where do you visualize ABLE will be in two years? In the next two to three years, I would expect ABLE to be not just a strong face of the Indian biotech sector but with a clear vision of a fairly well defined roadmap for a long term sustainable growth of the sector. ]]> <![CDATA[Don't ignore plastic disposables]]> https://biospectrumindia.com/news/95/2665/dont-ignore-plastic-disposables.html https://biospectrumindia.com/news/95/2665/dont-ignore-plastic-disposables.html Mon, 21 Jul 2003 21:07:00 +0530 Whenever we talk about biotechnology, the buzzwords are quality, precision, expertise and innovations. Many laboratories of international standards are coming up in India and most of them will use quality chemicals, enzymes, reagents and other consumables without which quality research is not only difficult but also impossible. It is little surprising that most of the time plastic disposables, which are an important component of the whole research process, are given neither due consideration nor proper recognition by researchers. We might use the most expensive chemicals and reagents, but the desired efficiency and required precision can never be obtained if the plastic disposables used along with this do not match the same quality standards. It is more or less similar to drinking mineral water in an unhygienic glass. As all consumables used in biotechnology are coming in direct contact with plastics, it is important that we study our plastic disposables minutely and efficiently. Otherwise, quality research will be impossible. The plastic disposables I am referring to are products like micro tips, micro centrifuge tubes, PCR tubes, range of high throughput screening products and high tech products like filter barrier tips and spin columns. The concept of using quality laboratory plastic disposables is gaining popularity among the scientific community now. This is mainly due to the easy availability of these products in the Indian market. Till a few years ago, getting these quality products here was a nightmarish experience. Accessing these products has become easier and affordable today. Having a long association with quality plastic laboratory disposables, I thought I must share some of my experiences with our elite scientific fraternity and assist them to access quality products to suit their requirements and save their precious time spent to scan the innumerable options availabletoday. Here's a checklist to refer while selecting the plastic disposables. â€¢ See if the products are RNase, DNase and pyrogen free which is a necessity in biotechnology research. â€¢ Find out the type of material a disposable has been made up ofâ€”whether it has come from 99.9 percent pure, virgin poly propylene or not. â€¢ Check whether the clarity of the tip is absolute or not because it plays an important part in your day to day experiments. â€¢ All plastic disposables, which are made without any fillers, lubricants, dyes, heavy metals, will always be more advisable than the ones where these important aspects have been ignored. Because if there are no additives chances of sample leaching are minimal. â€¢ Should always look for some special features that can give better precision during work, like having some engraved rings from inside at the top portion of the tip where the pipette shaft gets fixed up. Because this leads to the creation of vacuum and ensures that all dispensing is controlled by the thumb and no sideway displacements are possible. â€¢ A few tips are available with an exclusive feature of extended bevelleding which means that it has a special cutting in front of the tip that reduces the surface area of the tip orifice. This eliminates the capillary action and the last drop problem. â€¢ The mould in the plastic industry has the same significance as a soul in a living body and it is important that scientists should know what type of moulds have been used because the best moulds are the diamond polished ones which give absolute clarity and the finest finish. â€¢ Similarly in PCR products and Micro Centrifuge Tubes (MCT), rigorous quality control and quality assurance tests are required. Good MCTs will ensure that a researcher's valuable samples will not be destroyed due to popping up of MCTs even at 15,000â€“20,000 revolutions per minute and they will not leak even with the toughest solvents like phenol. Some companies are promoting such products with some special seals like a high pressure double ring seal to doubly ensure the safety of the samples. Scientists should insist on knowing what type of testing procedures the vendors follow. A recent report in the US revealed that due to the adherence of liquid samples to the walls of plastic pipette tips, MCTs and PCR tubes, significant amount of DNA, protein, enzymes or other samples may be lost. Also, DNA fragments tend to denature when binding to the polypropylene walls. Additional DNA tends to denature upon dehydration. Such problems could be significantly reduced if the selection of disposables is right. The study also showed that tubes manufactured by different companies behave differently as far as adherence and denaturization is concerned. The report concluded that the "MaxyMum Recovery" PCR tubes of multiwell plates under the given test conditions did not seem to encourage any high attachments of the tested biological molecules like DNA, its fragments or other peptides or proteins like collagen. The shown retardation of molecular binding to the surfaces of "MaxyMum Recovery" tubes could be due to their uniform ultra smooth surface properties resulting from unique manufacturing processes. The new age polymers used in the manufacture of these disposables eliminate many of the disadvantages of conventional polypropylene equivalents. Unlike standard polypropylene products, the walls and surfaces of products manufactured from these new ultra modified plastics are completely free from any occlusions or cavities. This virtually eliminates fluid retention during sample aspiration and the dispensing. These specialized products also ensure and give researcher an unparalleled confidence that the maximum volumes of enzymes or DNA could be transformed during the testing procedures and results obtained could be more reliable and dependable. All these ultra modern plastic disposables are available in the Indian market now. The author is, corporate VP (South East Asia), Axygen Scientific, New Delhi. Navneet Trehan ]]> <![CDATA[Status of technologies developed in India]]> https://biospectrumindia.com/news/95/1760/status-of-technologies-developed-in-india.html https://biospectrumindia.com/news/95/1760/status-of-technologies-developed-in-india.html Mon, 21 Jul 2003 21:00:00 +0530 Status of technologies developed in India (2002-2003) Patents filed by Indian companies (2002-2003) ]]> <![CDATA[Association(s) for growth]]> https://biospectrumindia.com/news/95/6643/associations-for-growth.html https://biospectrumindia.com/news/95/6643/associations-for-growth.html Mon, 21 Jul 2003 20:40:00 +0530 In April 2003, the biotech industry in India witnessed the birth of a new industry association. The Association of Biotechnology Led Enterprises (ABLE) was launched with a bit of fanfare. Some hailed the formation of ABLE saying that the biotech industry finally has an association while a few even commented that ABLE is the need of the hour. But what is the actual picture? The biotech industry in India has had an association for itself since 1994. Known as All India Biotech Association (AIBA), the stated purpose of this body is "to provide a common apex forum at the national level to represent the interests of all those engaged in various aspects of Biotechnology". In a well rounded statement, the main objectives of AIBA has been listed as "to promote and safeguard the overall interests of Biotechnology as a science, profession, industry or trade. That is pretty much any representative association would want to achieve. And so why form ABLE which is "envisaged as the collective face of India's biotech industry"? There is obviously an expectation mismatch amongst a section of the industry. A feeling that there is a gap between what AIBA has achieved and what it should have. Therefore ABLE was formed to close the gap. Assuming that there is a gap in the AIBA deliverables, should those issues have been addressed with AIBA itself or is it better to form a second association? Whatever the answer, ABLE has just been formed and they should be given time to perform. But God forbid, what happens if they are not able to. Will the biotech industry see the formation of a third association? A look at the history of trade and industry associations in India shows that we believe in numbers. Take the overall business and trade scenario. We have CII, FICCI, ASSOCHAM, FIEO and various export promotion councils. Or take the example of the IT industry in India. There is NASSCOM, MAIT and ESC at the national level and numerous others at the regional level. There is no doubt about it. We believe in numbers. Why take a risk with one? More the number of associations the better it is for the industry. Keeping this in perspective the biotech industry has just formed the second association and so the industry can say that it is in control and on the right track. Just think about this. If MAIT had done what was required would NASSCOM have been formed? Or for that matter why should NASSCOM have been formed when the Electronics and Software Promotion Council (ESC) existed? India would not have achieved international recognition for its software skills without the untiring efforts of NASSCOM. Similarly, the formation of ABLE needs to be welcomed but not at the expense of AIBA. The biotech industry needs untiring efforts from the two associations and cooperation wherever possible to ensure rapid growth and for putting India on the global BT map. There is no need to examine closely the objectives of AIBA and ABLE. Most of it would be common and there is no problem with that either. So what is the precious difference bet-ween the two? One of the views is that ABLE repre-sents the large companies while AIBA the medium and small ones. Another view is that ABLE is more South oriented and AIBA more North oriented. Yet another uncharitable view is that these associations are serving the personal agendas of a few people. Do we have to cast aspersions on one another? It is perhaps more prudent and practical to say that both ABLE and AIBA have a common goal and that is the growth of the Indian biotech industry. What are the ingredients required for ABLE and AIBA for achieving growth? An association should be representative of the industry it seeks to address, should involve the larger players (they have the muscle), needs funds, strong government interaction (the Delhi factor) and a charismatic and dedicated leader. Both ABLE and AIBA have its strengths but neither of them fits the bill entirely (or at least not yet) and therein lies the problem. Both are tackling the issue of funds and both do not have a Dewang Mehta. These issues need to be tackled. There will be many biotech organizations with membership in both the associations. They want leadership and results. They would stick with the association that delivers. In fact this is best illustrated by the success of NASSCOM. Started as an association for the software industry as MAIT was more representative of the hardware vendors, NASSCOM achieved more than the expectation of its members. Seeing its success, the ITES/BPO players have now taken shelter under the NASSCOM umbrella. Honestly, call centers are not IT organizations. They just use IT like other industries do. It's a symbiotic relationship. NASSCOM needs the BPO segment to achieve its projected export revenue numbers and the BPO players prefer to ride on the clout of an already established NASSCOM. What that means is that in the future one may see a merger between ABLE and AIBA. But for the moment the industry has them both. And while they are both there, it should be ABLE and AIBA and not ABLE versus AIBA. Both should work for the growth of the biotech industry. The need of the hour is association(s) for growth. Let the biotech industry flourish. E Abraham Mathew abrahamm@cmil.com  (The author is the Chief Editor of BioSpectrum) ]]> <![CDATA[The future of biotech industry in India is very bright]]> https://biospectrumindia.com/news/95/5825/the-future-of-biotech-industry-in-india-is-very-bright.html https://biospectrumindia.com/news/95/5825/the-future-of-biotech-industry-in-india-is-very-bright.html Fri, 13 Jun 2003 13:13:00 +0530 Ernst &Young (E&Y) is one of the world's top 4 technology consultancy organizations. E &Y has been globally active in biotechnology for some years now. It compiles the widely acclaimed Global Biotechnology Report every year. This year's report is likely to be released at BIO 2003, the annual meeting of the global biotech industry in Washington DC on 22-25 June. Driving E&Y's biotech initiatives in India is its Hyderabad-based director Utkarsh Palnitkar. He outlined the organization's pioneering activities in India in a chat with BioSpectrum. Excerpts: What is the total quantum of funds committed/disbursed so far to biotechnology companies in India? What is your estimate of the funding requirements of biotech industry in the next few years? The biotechnology commitments of different venture capital funds (VCFs) is estimated to be to the tune of Rs 300 crore (Source: RIS). The Small Industries Development Bank of India (SIDBI) and ICICI Bank have committed about 35 percent each. As revealed by a recent CII Survey, banks continue to remain the major financing source for biotech in India with venture capital accounting for less than 20 percent of the funding. The total project investment by the companies analyzed in the survey was over $100 million (Rs 480 crore) in the last decade. The companies have received over $1.5 million of VC funding from 1999-2001. The total private equity funding estimated to be made in the Indian biotech sector in the next 2-3 years is in the range of $ 100-200 million (Rs 480-960 crore). "One can only speculate that in the product patent regime post 2005, most small to medium sized Indian biotech companies may become attractive acquisition targets for big pharma and biotech companies and MNC contract research organizations (CROs) with deep pockets. I say this because global companies are increasingly recognizing India as a low cost hub for research and development." Ernst & Young has been working closely with many state governments and organizations to promote the biotechnology segment. Could you give some details? Our health sciences team has worked closely with the Government of Andhra Pradesh in its various initiatives for promoting biotechnology in the state, key among them being the formulation of the state's biotech policy, privatization of the biotech park and more recently the conceptualization and promotion of the Genome Valley bio-cluster. E&Y is the retainer consultant to the state for the biotech sector and has the mandate for attracting large private and foreign investments in this sector. E&Y is also a member of the Biotech Advisory Committee set up by the AP government for the promotion of biotechnology in the state. Our team has also served the state governments of Maharashtra and Kerala on assignments related to the biotech sector. There is a lot of government support to the biotech industry in the US, Israel, Canada and Australia. Is there any relevant model for India to design an ideal funding mechanism to promote the biotech industry? Angel funding or seed capital for biotech star tups is the primary need for this sector. Finding a solution to early stage biotech venture funding becomes all the more relevant, given that the majority of the opportunities are in the start up/early stage and are driven by research or researchers evolving from academic and research institution. Most companies require seed capital prior to the VC funding stage and here the government could perhaps play the all important role of an angel investor. In this context the Israel model where the government and the venture capitalist hold an equal stake in the company seems to be quite relevant to India. The government may exercise an exit route when the company is profitable by first offering to sell its stake to the VC itself. Interestingly enough, a declaration based on the Israel model is being drafted by Karnataka's Vision Group on Biotechnology to be presented for implementation by the state and the central government. Do you recommend Indian biotech companies to confine to product or services or some niche areas to make global impact quickly? Globally, the product paradigm has clearly emerged as one of the paths to sustainable growth in biotechnology. A quick look at the top 10 global biotech companies would reveal that nearly all are product companies. In fact, even leading tools and technology providers like Incyte, Applera Corporation and Millennium are now moving towards a product based business model. Global biotech companies have undergone a transition from being R&D focussed organizations to those that develop products and create licensable technologies. In India, the service model is the more popular entry strategy for star tups as risks are low and cash flows are positive from an early stage. What is your forecast about the growth prospects of the Indian biotech segment? Do you foresee any consolidation-taking place in the near future? Given the pervasive nature of biotechnology, it is expected that nearly all products in the future would become biotech oriented. As more and more organizations continue to embrace biotech based techniques, I suspect a time would come when one would be hard pressed to distinguish biotech from the mainstream. Having said that, the kind of support the government has shown to this sector and the missionary zeal with which the sector is being promoted by various industry associations such as CII, ASSOCHAM & FICCI, the future of the biotech industry in India undoubtedly seems bright. What we now need to look at is how the Indian biotech industry can move to the next step. With the present constraints on funding for biotech ventures, the only way I see companies in this sector growing is through collaborations, partnerships and alliances- both nationally and globally. One can only speculate that in the product patent regime post 2005, most small to medium sized Indian biotech companies may become attractive acquisition targets for big pharma and biotech companies and MNC contract research organizations (CROs) with deep pockets. I say this because global companies are increasingly recognizing India as a low cost hub for research and development. How many state governments have started exclusive venture funds for the biotech segment? There are, in fact, quite a few state government sponsored venture capital funds in the country today viz. APIDC Venture Capital (Andhra Pradesh), Karnataka State Industrial Infrastructure Development Corporation (KSIIDC), Gujarat Venture Finance Ltd and Kerala Venture Capital Fund. The state governments of Delhi, Tamil Nadu and Uttar Pradesh also have their own venture funds. Some of these states are also in the process of launching dedicated funds for biotechnology. N Suresh ]]> <![CDATA[Serum launches Pyginal]]> https://biospectrumindia.com/news/95/7950/serum-launches-pyginal.html https://biospectrumindia.com/news/95/7950/serum-launches-pyginal.html Fri, 13 Jun 2003 13:05:00 +0530 Pune-based Serum International Ltd (SIL), a subsidiary of Serum Institute of India Ltd, has launched a new drug Pygeum Africanum Soft Gelatin Capsules called 'Pyginal' for benign prostate hypertrophy (BPH). BPH is an age related prostate gland problem occurring in males after the age of 40-45 years. BPH occurs because of enlargement of the prostate gland which is an important organ of the male reproductive system. Pyginal is a phytochemical drug extracted from the bark of Pygeum Africanum, a tree found in south and central Africa. Pyginal offers anti â€“inflammatory, anti oedema and hypocholesterolemic action. Pyginal has shown significant improvement in BPH symptoms and reduction in the prostate size. For more details, contact: serumpg@eth.net Bharat Bio launches typhoid vaccine Hyderabad based Bharat Biotech International Ltd has come out with another product in preventive and affordable healthcare by launching Typbar. This is a highly purified Vi capsular polysaccharide typhoid vaccine. In the clinical trails the vaccine showed excellent protective efficacy. The protective efficacy is based on the titre of IgG, as this specific antibody is known to be the protective antibody in the immunoglobulin family. The trials showed no adverse reactions. Typbar, produced with an investment of Rs 17 crore, is the second vaccine from Bharat after its successful hepatitis B vaccine, Revac-B, launched in 1998. For more details, contact: info@bharatbiotech.com   Hi Tech introduces plug & play USB interface biomouse Bangalore-based Hi Tech Biometrics has introduced a unique plug and play USB interface biometric mouse for computers and laptops. The biomouse uses the template of the finger which is matched with the template of the user to protect and secure the data from unauthorized access. It has features like secure logon, folder protection, screen saver logon window etc. This can be used with existing networks, systems and applications providing highly secured authentication and identification mechanism. The biomouse will increase the security of the system when using finger print logon. For more details, contact: sales@hitechbiometrics.com Toshibha (India) brings out biohood Toshibha (India), manufacturer of biological safety cabinets, has come out with a biohazard cabinet named as biohood. This offers operators protection from low to moderate risk biological agents (or chemical carcinogens) while providing a sterile work environment for the procedure. It has applications in isolation and identification of plant/ human pathogens, work in virology, tissue culture, sterility testing and recombinant DNA research. Toshibha has designed this biological safety cabinet especially for wet processing, chemical work, critical biological work involving virus and pathogens and for microbiology, biochemistry etc. The cabinet has to be kept under negative pressure with partial quantity of re-circulated air exhausted through a filter. External exhaust from the laboratory is optional. For more details, contact: toshiba@del3.vsnl.net.in  Organica Biotech develops Bioclean series of products Mumbai based Organica Biotech has developed the BiocleanÃ¢ Series of products. Organica Biotech provides tailor-made BiocleanÃ¢ products for various industries/sewage treatment/lakes/ponds/aquaculture/hotels/solid waste. BiocleanÃ¢ is available in dry concentrate bacterial formulations specially designed to provide improved pollutant degradation. Each gram of the product contains upto four billion microbes. There are upto 76 different strains of bacteria in each BiocleanÃ¢ product depending upon the formulation type which can biodegrade diverse types of molecules. A unique combination of microbes and biochemical accelerators are processed in a specific proportion, designed to treat that particular waste. For more details, contact: contact@organicabiotech.com   Bhat Bio-Tech develops Pareekshak HIV tri line card test Bhat Bio-Tech India Pvt Ltd, Bangalore has developed a wide range of diagnostic kits for testing HIV. The HIV test ranges include rapid tests - Pareekshak HIV â€“1/2 rapid spot test, HIV â€“1/2 membrane ELISA and rapid card tests. The Pareekshak HIV-1/2 ELISA is a solid phase non-competitive sandwich ELISA with HRP and TMB as chromogen. This is the third generation rapid test developed by Bhat Bio-Tech that uses specific antigens with colloidal gold dye conjugate and detects IgG, IgA, and IgM antibodies. The product is sensitive even in early infection and detects low antibody levels there by reducing the window period. Using Pareekshak HIV tri line card test one can easily differentiate HIV 1 and 2 by clear line formation. For more details, contact: shambhat@vsnl.com ]]> <![CDATA[Why and what should be our biotechnology policy?]]> https://biospectrumindia.com/news/95/1109/why-and-what-should-be-our-biotechnology-policy.html https://biospectrumindia.com/news/95/1109/why-and-what-should-be-our-biotechnology-policy.html Wed, 11 Jun 2003 18:30:00 +0530 Biotechnology is destined to be one of the prime determinants of our life styles and of the way we think and react to situations in the present century and the next. The other such determinants being space science, new sources of energy, new materials, computers, microelectronics, robotics, automation and artificial intelligence. Like any such prime determinant in history mankind can use biotechnology either wisely to maximize benefit to the largest number of people around the world. This should be to help secure enduring peace or foolishly for the exclusive benefit of the greedy and the powerful, to create conflicts within a nation or between nations, to exploit the unprivileged and to do damage to large segments of our society. It is, therefore, essential that our country needs a biotechnology policy. In fact, since ours is a large country with enormous diversity in every respect from state to state, it would be advisable for each state to have a biotechnology policy which would be in consonance with a larger, more flexible national biotechnology policy. Before I enunciate the components of such a policy it is important to state that biotechnology is a hi-tech area. It requires substantial investment; yet it is labor intensive. It impinges on a variety of other areas, ranging from medicine and health to agriculture and industry. Its implications are many: social, economic, political, moral, ethical and legal. The biotechnology policy of the country defines the framework within which it is stated, areas where emphasis is to be laid, the kind of assistance and support that will be available from the government and how the responsibility for meeting the desired goals is intended to be assigned. The biotechnology policy must also state in detail the mechanism of its implementation and assessment. Any biotechnology policy should, in addition, also state the following: The importance, role and the scope of biotechnology. The world scenario and prospects in the various areas of biotechnology and many linkages of biotechnology with other areas of human endeavor. Basic requirements that need to be met in the various areas of biotechnology. The Indian advantage with special reference to the state concerned. What has been done in our coun try in each area. The chosen priorities and the ra tionale for them. The envisaged mechanism (in some detail) for achieving the priorities and how would the problems that may arise be overcome. The new institutions such as the biotech park, the new commit tees and the new funding agen cies and their terms of reference. The time-frame for accomplish- ing the objectives. The role of the government (for example, the real incentives to the existing and the new biotech nology industries), the institu- tions, the committees and the organizations involved. The mechanism of networking and monitoring. An appropriate regulatory mechanism. An example of what the biotechnology policy should not be is the Andhra Pradesh government's Biotechnology Policy announced in 2001. It didn't even touch upon most of the above-mentioned items; the coverage of the rest without a single exception was either inaccurate or inadequate. The policy document, released with much fanfare, was prepared by a commercial organization, apparently under the guidance of a committee appointed by the state government. Not one practicing biotechnologist-that is a person from the biotechnology industry in the state- was on this committee, nor was anyone else out of the many who have personal experience of biotechnology within the state. It was, therefore, not surprising that the document abounded in incorrect factual (and easily verifiable) statements, cliches, muddled objectives, unclear strategies and erroneous arguments and statements. It gave no blueprint of how the state was going to achieve what has been set out in the policy for what ever it may be worth. There were incentives mentioned for those who would set up biotech industries in the state afresh but not for those who already had set up such industries in the state against innumerable odds. Pushpa M. Bhargava, one of India's most brilliant scientists, has founded and directed the Centre for Cellular and Molecular Biology (CCMB), Hyderabad.His scientific contributions include the preparation and characterization of primary liver cell suspensions, identification of proteins from the seminal plasma and extensive characterization of one of these proteins and seminalplasmin. He has been awarded with Padma Bhushan, the Legion d' Honneur, the Wattumul Memorial Prize and Goyal Prize. Varaprasada Reddy, managing director of Shantha Biotechnics, who pioneered the biotechnology industry in the state and genetic technology in the country, has suggested important incentives that can facilitate and catalyze the development of biotechnology industry in a state. These include land developed infrastructure (such as with water, power, access roads, wide band internet connectivity) to be made available initially at a nominal cost and the balance to be collected when the unit is successful. Then the arrangements of soft loans to pay customs duty on imported capital equipment and consumables could be recovered when the unit goes on stream. A government supported centralized arrangement for obtaining the clearances from central government agencies like the environment ministry, DBT, drugs controller general of India and so on; preference by government departments to biotechnology products from local industries without compromising on quality and competitive prices. Creation of ITI - like institutions to give appropriate training to laboratory assistants, technicians and other service personnel required by the biotechnology industry; sales tax holiday for ten years; and concessional electricity tariff for the first five years. The Biotechnology Policy of Andhra Pradesh has not recognized that these incentives could, in long run, bring substantial revenues to the state and more than compensate for the concessions given initially. Biotechnology has come to stay and will be a major technology of the future. Therefore, a biotechnology policy must plan for the future and any immediate expenditure on supporting biotechnology industry in a state and in the country must be regarded as an investment for the future which could bring unimagined returns. The central and the state governments could even consider buying equity in some of the biotechnology industries in the country that show unusual promise; this could be done through the state aided financial institutions. Unfortunately, we only have politicians as leaders who make decisions and not visionaries or statesmen. Let's hope that this is a transient situation and that, hopefully sooner but surely later, our leadership- both present and prospective- both at the center and in the states would recognize what needs to be done in the exciting area of biotechnology. PM Bhargava ]]> <![CDATA[Last Page]]> https://biospectrumindia.com/news/95/2552/last-page.html https://biospectrumindia.com/news/95/2552/last-page.html Wed, 11 Jun 2003 18:28:00 +0530 Crazy Patent There have been a lot of controversies in the past few years about various countries issuing patents for well-known or "obvious" ideas. Assuming it's not an elaborate practical joke, US patent #5443036 appears to be a good example of this. The patent refers to a method of exercising a cat by Kevin T. Amiss and Martin H. Abbott. The patent has been granted to a method for inducing cats to exercise and it consists of directing a beam of invisible light produced by a hand-held laser apparatus onto the floor or wall or other opaque surface in the vicinity of the cat. Then move the laser so as to cause the bright pattern of light to move in an irregular way fascinating to cats and to any other animal with a chase instinct. Source: Swiss Jokes Vinegar 'pinpoints cancer' Vinegar can help to identify cervical cancer in women. Research carried out in South Africa has found that washing the cervix or neck of the womb with vinegar shows up potentially cancerous cells, reports the BBC World Service. An early trial has suggested the technique is as effective as a pap smear which is the more usual way of spotting the disease. Doctors believe their research could pave the way for developing countries to introduce a cheap and effective screening program for cervical cancer. Vinegar comprises 95 percent water and 5 percent acetic acid. When this solution is placed on the cervix, it turns potentially cancerous tissue white. This enables nurses to offer patients an immediate diagnosis by simply looking at the cervix. This compares with a pap smear which usually needs to be sent off to a laboratory for testing. Dr Lynn Denny, a gynaecologist at Groote Schuur Hospital in Cape Town and one of those involved in the trial, said results are promising. "We are using this method almost like a pap smear. We have found that the ability of direct vision inspection is as good as and sometimes better than a pap smear," she said. "This test will identify white lesions on the cervix that are pre-cancerous lesions, equivalent to what the pap smear will detect." Many countries in the developing world are unable to afford to implement a national screening programme for cervical cancer. Dr Denny believes this technique could offer them a viable alternative. Doctors at Groote Schuur Hospital buy their vinegar at a local supermarket. "It is not just cost effective it is also logistically a much simpler method of screening," she said. "No extra infrastructure is required and we are using the most rudimentary equipment." The only drawback to the vinegar test is that it sometimes suggests women have cervical cancer when they do not - so-called false-positive results. However, this also occurs with pap smears. "You end up over-treating large numbers of women," Dr Denny said. This story is featured in the radio programme Health Matters on the BBC World Service. A glossary of genome expressions Backcross: A cross between an animal that is heterozygous for alleles obtained from two parental strains and a second animal from one of those parental strains. Also used to describe the breeding protocol of an outcross followed by a backcross. Bacterial artificial chromosome (BAC): A vector used to clone DNA fragments (100- to 300-kb insert size- average, 150 kb) in Escherichia coli cells. Based on naturally occurring F-factor plasmid found in the bacterium E. coli. Base: One of the molecules that form DNA and RNA molecules. Base pair (bp): Two nitrogenous bases (adenine and thymine or guanine and cytosine) held together by weak bonds. Two strands of DNA are held together in the shape of a double helix by the bonds between base pairs. Base sequence: The order of nucleotide bases in a DNA molecule; determines structure of proteins encoded by that DNA. Base sequence analysis: A method, sometimes automated, for determining the base sequence. Behavioral genetics: The study of genes that may influence behavior. Bioinformatics: The science of managing and analyzing biological data using advanced computing techniques. This is important in analyzing genomic research data. Bioremediation: The use of biological organisms such as plants or microbes to aid in removing hazardous substances from an area. Biotechnology: A set of biological techniques developed through basic research and now applied to research and product development. In particular, biotechnology refers to the use by industry of recombinant DNA, cell fusion, and new bioprocessing techniques. Birth defect: Any harmful trait, physical or biochemical, present at birth, whether a result of a genetic mutation or some other nongenetic factor. Blast: A computer program that identifies homologous (similar) genes in different organisms, such as human, fruit fly, or nematode. ]]> <![CDATA[GM crops The desperation grows]]> https://biospectrumindia.com/news/95/1629/gm-crops-the-desperation-grows.html https://biospectrumindia.com/news/95/1629/gm-crops-the-desperation-grows.html Wed, 11 Jun 2003 17:17:00 +0530 Accusing Europe of undercutting efforts to feed starving Africans by blocking the use of genetically modified crops which could "dramatically" boost productivity, the American administration fired the first missile by formally announcing to launch a complaint with the WTO against the European Union for its five-year ban on approving new biotech crops. This has set the stage for an international showdown over an increasingly controversial issue. "Our partners in Europe are impeding this effort. They have blocked all new biocrops because of unfounded, unscientific fears," Bush said. "This has caused many African nations to avoid investing in biotechnologies for fear that their products will be shut out of European markets. European governments should join â€” not hinder â€” the great cause of ending hunger in Africa." The US Trade Representative Robert Zoellick added that the European policy is illegal, harmed the American economy, stunted the growth of the biotech industry and contributed to increased starvation in the developing world. Coinciding with the frontal attack through the dispute panel is another seemingly harmless exercise to close ranks around flawed economic policies. Senior officials of the WTO-IMF-World Bank met at Geneva in May to deliberate on how to bring greater 'coherence' in their policies through 'liberalization of trade and financial flows, deregulation, privatization and budget austerity'. As if loan conditions of the IMF/World Bank that have forced developing countries to lower their trade barriers, cut subsidies for their domestic food producers and eliminate safety nets for rural agriculture were not enough, the WTO Agreement on Agriculture could be used very effectively to allow America â€” and 12 other food exporting countries â€” to dump unwanted genetically altered foods thereby destroying food self-sufficiency in developing countries and expand the markets for large grain exporting companies. Trade and financial manipulations alone are not enough. Already with the mainline science â€“ and that includes the Indian Council of Agricultural Research (ICAR) and the Council for Scientific and Industrial Research (CSIR) â€” under the captive control of the corporate world, the industry is now getting restless at the way the developing country governments are throwing in impediments in the fast-track destruction of food self-sufficiency. After all, as long as developing countries remain self-sufficient, GM crops will not have an opening. The focus therefore is not on how to strengthen the food self-sufficiency movement in the developing world but on how to make these countries become dependant on the GM food produced in the technology-rich countries. Mounting food subsidy and the resulting dumping of grains has already forced millions of small and marginal farmers in the developing world to be driven out of agriculture to move to the urban slums in search of a menial living. Highly subsidized agriculture in America and for that matter in the OECD is the root cause for growing hunger, destitution and poverty in the majority world. GM foods, produced by the biotechnology corporations, will further exacerbate the food crisis â€“ eliminating in the process not hunger but the hungry. Ironically, it is famine, hunger and the accompanying lies that has become the normal campaign route to push unwanted and highly risky genetically altered crops and foods. In India where hunger co-exists with over-flowing food stocks, the entire scientific community (and the industry) is busy diverting the national attention from the more pressing problem of food insecurity to promoting biotechnology. Unwanted crops â€” like Bt cotton and GM Mustard â€“ are therefore being promoted by hoodwinking the gullible farmers with lies and damn lies. The secretary of the Department of Biotechnology has gone on record saying that Bt cotton increases the yield by as much as 80 percent. She has even said recently that GM potato (which is still under trials) will contain 40 percent protein. In reality, Bt cotton does not increase crop yield (not even in China which has a huge area under the genetically modified crops and where the negative impacts have begun to show) and GM potato contains only about 2.5 percent proteins. At the international level, the global offensive is being built around coercion. Therefore, three ministers from 180 countries â€“ and holding the portfolios of trade, agriculture and health â€” will assemble at downtown Sacramento in California on June 23-25. The invitation which comes from the US Agriculture Secretary Ann Veneman is essentially for educating (in reality, intimidating) these democratically elected representatives on the virtues of GM foods and why they must back the US transnational corporations fight against global hunger. If not then why they must remain quiet. Ann Veneman will explain the 'consequences' â€“ both economic and political â€“ of not accepting the fruits of 'cutting-edge' technology, as genetic engineering is fondly called. The overt and covert machinations to push unhealthy and risky GM foods had actually begun a decade ago. The US has so far opposed the Cartagena Protocol on Biosafety which has been signed by over 100 countries and was intended to ensure, through agreed international rules and regulations, that countries have the necessary information to make informed choices about GM foods and crops. With the WTO appearing on the scene, the Cartagena Protocol has become meaningless. Since the Convention on Biological Diversity (CBD) has not been ratified by the US, it is not under any obligation to follow the Biosafety protocol. At the same time agricultural research which has been instrumental in ushering in food self-sufficiency in many of the developing countries in the post-green revolution era is being gradually dismantled. The Consultative Group on International Agricultural Research (CGIAR) itself is under tremendous pressure from the agri-business corporations which sees it as the main obstacle in the process of control and manipulation. With research priorities shifting from national requirements to servicing the biotechnology industry, like in India, it will be a matter of time before developing countries begin to return to the frightening days of 'ship-to-mouth' existence. Even food aid is being used to push GM foods. It is no longer about humanitarian needs of starving populations but about the commercial interests of the transnational corporations. First finding an outlet for its mounting food surplus through the mid-day meal scheme for African children (force fed through the World Food Program), the US then literally arm-twisted four African countries to accept GM food at the height of the food scarcity that prevailed in central and southern Africa in 2002. It even tried forcing the International Federation of Red Cross to lift the GM food as part of an international emergency so as to feed the hungry in Africa. As long as developing countries remain self-sufficient, GM crops will not have an opening. The focus therefore is not on how to strengthen the food self-sufficiency movement in the developing world, but on how to make these countries become dependant on the GM food produced in the technology-rich countries. It didn't however work. Zambia and Zimbabwe led the resistance against GM foods saying that it would prefer its poor to die than to feed them with unhealthy food. The US has therefore found a way out to circumvent and to force the African countries into submission. The US Senate has passed a bill in mid-May entitled "the United States Leadership Against HIV/AIDS, Tuberculosis and Malaria Act of 2003," (HR 1298)" which in a diplomatic way (calling it as 'sense of Congress') links financial aid for combating HIV AIDS with GM food acceptance. Section 104A states that "individuals infected with HIV have higher nutritional requirements than individuals who are not infected with HIV, particularly with respect to the need for proteins. Also there is evidence to suggest that the full benefit of the therapy to treat HIV/AIDS may not be achieved in individuals who are malnourished, particularly in pregnant and lactating women." The next sentence reads, "it is therefore the sense of Congress that United States food assistance should be accepted by countries with large populations of individuals infected or living with HIV/AIDS, particularly African countries, in order to help feed such individuals." The underlying objective is very clear: the US can use the verdict to stop humanitarian aid for HIV/AIDS unless the recipient countries first buy GM food. Killing two birds with one stone, you have probably forgotten that saying. This is not an isolated effort. Way back, in 1986, the US had similarly enacted a legislation, called Bumper's Amendment, that prohibited "agricultural development activities, consultation, publication, conference or training in connection with the growth and production in a foreign country of an agricultural commodity for export which would compete with a similar commodity grown or produced in the US." As a result the American support for research and development for crops which competed with those grown in the US were stopped. With national research programs closing down for paucity of funds, the field is now open for the biotech industry to take over. For pushing GM crops another outlet has now been created. The Rockefeller Foundation, in collaboration with the US-based Madison Institute, has launched a project called the 'Madison Initiative'. Under the guise of humanitarian aid and support the 'Madison Initiative' is aimed at pushing GM crops to tide over the increasing food insecurity arising from the growing vulnerability of HIV/AIDS affected economies. The basic premise being that HIV/AIDS has taken a heavy toll of able-bodied rural males in most parts of Africa. As a result, there is not enough manpower left in the rural areas to undertake agricultural operations like spraying of pesticides. Therefore, these countries must accept GM crops like Bt corn which they say require less chemical sprays! This 'wonderful' initiative is being executed by CGIAR as an active partner. Such was the desperation that agricultural scientists had met former President Moi of Kenya who had agreed to officially support the 'Madison Initiative' subsequently to be extended to other Africa countries, including South Africa, and then to India, Pakistan, Bangladesh, Thailand and to other parts of Southeast Asia, to push their case. Never in the past history has any government stepped in to force the world and that too literally down the throat into accepting what it produces. Never before has the world been forced to accept technologies (howsoever risky these might be) and that includes nuclear power, in the name of poor, hungry and sustainable development. Never before has any country tried to force feed a hungry continent by creating a false scenario of an impending famine which never happened. Never before has science and technology been sacrificed in such a shameful manner for the sake of commercial growth and profits. The world has been made to forget the age-old Chinese adage, " if you want to feed a man for a day give him fish. But if you want to feed him for life teach him how to catch fish." The ability to catch fish or in other words to produce food locally has been gradually destroyed. The hungry are now expected to buy food produced by biotech companies. And therein lies a grave danger. Devinder Sharma ]]> <![CDATA[Bioinformatics: Big for the Big Blue]]> https://biospectrumindia.com/news/95/1898/bioinformatics-big-for-the-big-blue.html https://biospectrumindia.com/news/95/1898/bioinformatics-big-for-the-big-blue.html Wed, 11 Jun 2003 15:58:00 +0530 With a lot of activities taking place in biotechnology and life sciences in India how does IBM see the scope/future for the life sciences in the country? IBM believes that India offers a strong market potential to be tapped for IBM Life Sciences offerings and hence is looking at tapping the potential of this developing market. IBM Life Science Solutions provides the IT infrastructure that researchers in biotechnology, pharmaceutical research, genomics, proteomics and healthcare need to turn data into scientific discovery and new treatments for diseases. Combined with IBM's core strength in providing robust technology and global services, the IBM Life Sciences business unit delivers innovative, scalable infrastructure solutions that are unique to the life sciences industry. What are the specific industry segments that IBM plans to address in India? IBM Life Sciences plans to address pharmaceuticals, biotechnology, academia and government research in India. Where does India stand in the global Biotech map? The alignment of a vast pool of scientific talent, a world-class IT industry, a vigorous generic pharmaceutical sector and government initiatives in the establishment of public sector infrastructure and research labs are positioning India to emerge as a significant participant on the global biotech map. What are the marketing opportunities for IBM products in India? The Indian pharmaceutical market shows positive signs. The Indian Government through the Department of Biotechnology has also been promoting the growth of this industry. The DBT and the Indian Council of Agricultural Research (ICAR) have stressed the importance of research and development for biotechnology. The Indian life sciences market has the potential which we would be looking at tapping in keeping with IBM's global focus on Life Sciences. Who are your customers, globally? IBM's deep computing technology, software and algorithms are helping Hospital for Sick Children, the largest pediatric center in North America identify the genetic causes of such diseases such as cystic fibrosis. The hospital hosts the worldwide Genome Database, the foremost public database for human genomic information, on an IBM supercomputer. John Hopkins University uses IBM supercomputing, advanced visualization and imaging technologies to help find cures for diseases of the heart and brain. The technology is shortening research time and helping speed drug development. Aventis, a world leader in life sciences, uses IBM systems for its IT infrastructure, including managing the bioengineering of new crops through Aventis' CropScience application. Incyte Genomics Inc., a leader in providing genetic content, will embed IBM's DiscoveryLink data integration technology into its new offering, Genomic Knowledge Platform. Using DiscoveryLink, the new software platform will seamlessly integrate genomic analysis tools and diverse data sets, such as DNA sequence, gene expression, proteomics and genetic variations which are often in disparate formats, to enable faster and more comprehensive analyses than ever before possible. In that way, the combined technologies will address a critical problem in life sciences: accessing and analyzing ever-increasing amounts of biological data to uncover patterns and associations that can lead to new scientific discoveries. Wayne State University is using an IBM supercomputer to help understand the billions of pieces of raw data that have been painstakingly collected during the decade-long effort to decode the DNA molecule â€” the genetic blueprint of life. The research is intended to pave the way for revolutionary new drugs in the fight against cancer and other life-threatening diseases. Simply stated, our unique combination of domain expertise and traditional IT leadership helps customers bridge the gap between the computational and the science side of drug discovery An IBM supercomputer at the San Diego Supercomputer Center is helping researchers better understand the workings of the human nervous system and design the next generation of drugs against HIV and other diseases. IBM is also working with Korea's Institute of Science, Technology and Information (KISTI), providing them with one of the most powerful supercomputers (IBM eServer POWER4 technology) for use in Korea's life science and high performance computing research efforts. IBM is also cooperating with KISTI to help build the nation's Technical Support Center for High Performance Computing and Life Science Support Center. IBM will provide technical expertise and resources in cooperation with its global supercomputer research support centers. This contract was worth $27 million. How do you meet the needs of the biotech industry? IBM aims to meet this computational challenge which requires analyzing, sorting and studying enormous amounts of information and collaborating with research centers and other scientists throughout the world. Among the IBM offerings are high-performance computing, data management, advanced storage management, consulting services, knowledge management, collaborative technology and e-business solutions. Simply stated, our unique combination of domain expertise and traditional IT leadership helps customers bridge the gap between the computational and the science side of drug discovery. It's all about running the business faster, better, and economically. What are IBM's global initiatives in life sciences? The formation of the specialized IBM Life Sciences Solutions business unit. The active pursuit of strategic business partnerships with life sciences companies whose complementary skills, knowledge and resources could help build value-rich solutions for the industry. The formation of a dedicated IBM Global Life Sciences Consulting and Solutions practice to focus IBM service capabilities, expertise and intellectual capital on helping customers and business partners to migrate their R&D units into even more efficient and competitive operations. Two key research centers, the IBM Computational Biology Center and the IBM Deep Computing Institute, housing teams of scientists working on projects involving computational biology, chemistry and material science. Long-term projects at the IBM Computational Biology Center foster IBM collaboration with life sciences companies to bring scientific expertise directly into the development of life sciences solutions. ]]> <![CDATA[The magical tango of IT and BT]]> https://biospectrumindia.com/news/95/2042/the-magical-tango-of-it-and-bt.html https://biospectrumindia.com/news/95/2042/the-magical-tango-of-it-and-bt.html Tue, 10 Jun 2003 21:19:00 +0530 Biology has always been exciting. For every new development here has taken humans a small step closer to making some sense out of the mystery surrounding life forms. IT, on the other hand, has jumped from one fancy segment to another. After the fancy over the dotcoms and Y2K had faded, bioinformatics has become the replacement. Industry experts believe that bioinformatics represents the next big opportunity for the IT industry since Y2K. After the September 11 incidents, the Indian IT sector has zeroed in on life sciences and healthcare as the new opportunity areas. Not just IT. The pharmaceutical industry too has increased its involvement in the bioinformatics sector. Pharma companies too are increasingly relying on the power of computers to speed up the new drug discovery process and develop new molecules. Bulk of the bioinformatics companies are based in Bangalore, Pune, Hyderabad, Chennai and Delhi. These companies have come up in the clusters where there are a large number of IT, biotechnology, pharmaceutical and bulk drug manufacturing firms. The major pharma and biotech companies like Dr Reddy's Lab, Shantha Biotech, Bharat Biotech, Biogenus, Indigene etc., are based in Hyderabad. Similarly in Bangalore there are major biotech firms like Biocon, Avesthagen, Metahelix, Astra Zeneca, etc., which rely on computing power to some extent. Bioinformatics companies are not fully dependent on Indian customers. They are actively looking for market opportunities in the US, Europe and Australia. Most of the bioinformatics companies in India are in the small and medium enterprises(SME) segment with 20-50 employees. The bioinformatics divisions of IT companies too are small in size. A parallel private training industry to rival the formal education stream is also coming up in biotechnology, as was the case in computer software. Some of the companies have come out with products too. Companies like Strand Genomics, Ocimum Biosolutions, Mascon have developed some products and services. Products require intensive efforts to market and an efficient distribution channel. A typical bioinformatics product would take a year to develop and another year or more to reach the market. Most of the Indian companies in this domain are small players and do not have deep pockets to sustain the products over a long time. "Initially there were only few bioinformatics companies and they either decided to do contract research or never got about releasing their products. Many of the companies said they were bioinformatics companies and they were either training companies or services oriented companies," explained Anuradha Acharaya, CEO, Ocimum Biosolutions, Hyderabad In the long run India has several advantages which this sector could take advantage of. The vast genetic resources, diverse ethnic population, highly evolved indigenous systems of medicine could provide valuable clues to discover new drug molecules. What to do to grab big global market share The government should ensure l Adequate bandwidth for IT enabled services for genomics l Increase in outlay of funds for R & D, validation, product and market development in this sector l Focus on functional genomics and proteomics l Create a modern and efficient patent office and a globally integrated FDA database in India l Form cross-functional teams across ministries of health, biotechnology, science and technology, IT and industry The industry needs to set up l A corporate organization with top class people from molecular biology l Integrate this group with statisticians l Make a group of solid software companies with the ability to provide complex solutions and market it globally l Work out a time line for next three years l Define the kind of partnerships and institutional framework s required Success stories Strand Genomics is the first and one of the most successful firms in bioinformatics. Its success is based on a service delivery model relying on data management and development of customized data mining software for customers. Strand has also developed several propriety mining software products which have been licensed to some of the US biotech companies. Other major companies providing services in bioinformatics include CDC Linex, Bigtec, Institute of Bioinformatics, Jubilant Biosys, Ocimum Biosoultions, Mascon Life Sciences, Bilcare, Scinova, SysArris and Molecular Connections. Software companies like Infosys Technologies, Wipro Health Sciences, Tata Consultancy Services, Kshema Technologies are also exploring the opportunities in data management sector. Even the US companies like Affymax, Monsanto and others have also established informtatics division in India to take advantage of low cost software development skills. Genomics With the genomics research making rapid strides, the volume of life sciences related data is expected to double in the near future. This makes biology a major topic for increased use of computer applications to study the data. The large skill base of software specialists in India is making it a key player in this emerging market segment Indian companies could play a significant role in areas such as data handling, data mining genotying, fingerprinting and DNA sequencing. This sector has a significant growth potential and is expected to grow to a global market size of $3.2 billion by 2005. It is estimated that up to 10 percent of the investment today in R&D is IT related. There is a huge potential for Indian biotech and IT companies to enter into collaborative bioinformatics research with global pharma majors in the near future. This sector in India, at the moment, is in the early stages of development. Every one is eagerly watching which business models would become successful. Now genomic databases are mostly with specialist biotech companies and a successful business model may emerge with the bioinformatics business built around these databases. A player to watch in this segment is the Bangalore-based Institute of Bioinformatics (IOB) which is engaged in cutting edge research in genomics and proteomics. It had recently completed its first international project on the creation of Human Protein Reference Database. The company is in the final stages of completing another resource - a cancer microarray database called Oncomine in collaboration with scientists at the University of Michigan, Ann Arbor in the US. "We are not looking at any particular market but because of the nature of our work we are looking at the entire human population so that we can try to ameliorate their sufferings," said Akhilesh Pandey, chief scientific advisor of IOB. Opportunities in biopharma Apart from genomics, the field that is driving bioinformatics is the drug discovery process that includes techniques of data mining, scientific visualization, information storage, retrieval of special structure, data and simulation of very long DNA sequences. Pharma and food industries are making significant investments in this sector. Companies like Biocon, Dr Reddy's Lab, Ranbaxy are looking at this sector to reap the advantage of being early movers. Major pharma and biotech companies like Amgen, Boots Healthcare International, GlaxoSmithKline, AstraZeneca, Pfizer International and others are already the clients of Bangalore based SysArris Software Pvt Ltd that caters to the needs of the drug discovery and development process. "We have a good number of clients.. Our product design capabilities are not restricted to a one-time make-and-implement approach. We undertake the development of commercial, off the shelf software for clients that span several versions, upgrades and updates over the product life cycle," said Ajay Simha, a director of SysArris. In 2000, the worldwide pharmaceutical market, according to IMS Health, totaled $317 billion and it could reach $3 trillion by 2020. However the industry could achieve such growth only if it brings many new drugs in to the market. This challenge could be met only if the industry finds an effective solution to speed up the process of identifying novel drug targets and taking them to the markets fast. Bioinformatics offers pharma companies the chance to participate in the front-end drug discovery process. Experts estimate that genome research could identify 3,000-10,000 new targets for small molecules. Currently, the industry is working with a potential target of just over 500 proteins. To take advantage of the new opportunities pharma companies are developing a variety of strategies to access and exploit the research findings with the help of bioinformatics companies. There are words of caution too. "Indian biopharma is still in the infancy stage as far as data driven drug discovery and developments are concerned. About 80 percent of the action in biopharma at present is taking place in the US,"noted Strand Genomics chairman Prof Vijay Chandru." We are, however, focusing on the markets in Europe and Asia Pacific too for marketing our tools." The global bioinformatics industry clocked revenues of $ 2 billion in 2000. It is expected to grow to $6 billion by 2005. India has the potential to grab a big part of this pie if the industry and government work in tandem.It is a promising sector for Indian entrepreneurs. However, bioinformatics may never scale the magnitudes reached by the software segment as the whole pie may continue to be small relative to the IT segment for many more years. Narayan Kulkarni ]]> <![CDATA[A versatile gene lab]]> https://biospectrumindia.com/news/95/8188/a-versatile-gene-lab.html https://biospectrumindia.com/news/95/8188/a-versatile-gene-lab.html Tue, 10 Jun 2003 21:03:00 +0530 Established in 1966, as the center for biochemical technology (CBT), the institute has emerged as a full-fledged laboratory in the CSIR set up. Initially the center was started as the "biochemicals unit" with a grant-in-aid project from the CSIR to provide rare biochemicals and reagents for biomedical research in India. To reinforce the efforts to place India on the world map by carrying out cutting edge research, some strategic changes were made by CBT last year. An important step in this direction was to change the name of the institute to the Institute of Genomics and Integrative Biology (IGIB). This change of name was based on the assumption that the new name would give impetus to the focus area and shall also project the motto of study of biology in an integrative manner. It was in line with the distinctive image of the institute with it's new R&D programs such as comparative genomics, proteome analysis, in-silico drug target discovery, novel screens for drug target development, SNP analysis for predictive medicine were taken up to develop effective, competitive and commercializable technologies for new drug discovery. A network program on functional genomics, supported by the Department of Biotechnology (DBT) was initiated at IGIB in 1988. An interactive program involving molecular biologists, immunologists, organic chemists, molecular geneticists and information technologists along with medical scientists from various institutions in the country was envisaged to make use of the knowledge derived from genomics. The laboratory is working on major projects related to immunology and molecular genetics of respiratory disorders including allergy, fungal infections and predisposition to asthma, molecular genetics of neuro-psycho disorders and functional significance of repetitive sequences in the genome, genome informatics and drug target identification. IGIB is also working on the development of molecular markers for pathogenic organisms, including Mycobacterium tuberculosis, molecular recognition/interaction studies,design and synthesis of modified oligonucleotides for antisense and gene targets and design, synthesis and structural studies of peptides with a role in neurological function and dysfunctions. IGIB has world class equipment and infrastructure facilities for genomic research. The institute has plans to come up with a new P3 grade biosafety facility. In terms of infrastructure and special facilities, IGIB is rated to be among the top five institutions in the country IGIB has partnered with Chatterjee Group to establish a technology incubator along with genomic service facilities. IGIB has been focusing on collaborative research with other leading institutes/laboratories and with large corporate players in recent times. The institute has partnered with Nicholas Piramal Pvt. Ltd., a leading pharma company to set up a joint research project called "Genomed". The institute also has a joint research agreement with Bharat Biotech, Hyderabad, under the Technology Development Board (TDB) program of the Department of Science and Technology (DST). IGIB is also actively engaged in developing the human resources in areas involving new biology and information technology. Anticipating the arrival of the first draft of the human genome sequence and that of a large number of model organisms, the institute has positioned itself as a leading 'knowledge center of genomics research' in the country and globally. The institute has also tied up with Chembiotek, a unit of the Chatterjee Group, Kolkata, for human resource development in the area of bioinformatics. To cater to the increasing demand for space, the institute is looking forward to its shift to the new twin-building campus proposed to be constructed on Mathura Road in South Delhi. Faiz Askari "The coming era will belong to hybrid scientists" Dr Samir Brahmachari needs no introduction to the community of biotechnologists in India. As the director of the New Delhi based Institute of Genomics and Integrative Biology (IGIB) since August 1997, he is actively involved in furthering the cause of genomis and biotechnology in the government, academia and industry. IGIB is one of the recent stars of the 38-laboratory chain of research centers run by the Council of Scientific and Industrial Research (CSIR). Before he joined the CSIR family, Brahmachari was a professor at the Indian Institute of Science, Bangalore, a premier research center. IGIB hit the headlines recently when a group of scientists at the institute developed a globally competitive software program which allowed decoding of the genome sequence of the SARS (severe acute respiratory syndrome) virus. Brahmachari and his laboratory is an example of the successful handling of the emerging convergence of information technology and modern biology. He strongly feels that the coming years will see the emergence of a new breed of hybrid scientists working in both information technology and biotech who will create a new paradigm in the biotechnology arena. As an active researcher, his topics include functional genomics, genome informatics and structural biology. Brahamachari has won a number of prestigious awards such as the Young Scientist medal (Indian National Science Academy in 1979, Kani medal (National Cancer Research Center, Tokyo in 1981) Shanti Swarup Bhatnagar Prize (1990), R Krishnamurthy Award (Society of Biological Chemists, India in 1998). FICCI Award 1998-'99 and the Millennium Medal (Indian Science Congress, 2000)and Goyal Prize 2001. He was elected as a member of the Human Genome Organization (HUGO) in 1991. Brahmachari has also received the Ranbaxy Research Award - 2001 for outstanding contribution in medical sciences in January 2003. He is currently working on disease genomics and functional genomics in silico. Brahmachari shared his vision for the Indian biotech industry in an exclusive chat with BioSpectrum. Excerpts: How do you rate the success of IGIB? Over a very short period of time, the kind of responses we have got from the industry have motivated us to work for further success. We hope that industry participation with IGIB will continue to grow in genomics and bioinformatics. Our aim is to become a major knowledge provider in biotechnology. Our talented young work force also makes me feel proud. I am saying this after giving more than 100 lectures in various gatherings of people from the knowledge sector and interacting with the participants from schools to CII shows in the past few years. Which are the major thrust areas at IGIB? Functional genomics, disease genomics, diabetes and neuro-psychiatric diseases are among our focused areas. Apart form these we are also going to expand in silico biology because the scenario in the coming four or five years will be more in favor of "information scientist" rather than pure biologists or hardcore computer professionals. Our effort is to create over 25 hybrid scientists in IT and biotech. In the future, this work force will be the backbone of IGIB. India is well known for its knowledge base. Do you think that it is now the time to keep the knowledge base intact within India ? Our scientists leave the country only to move to a hassle-free work environment. If we succeed in creating the hassle-free environment here itself, then we can keep our work force intact. At IGIB we are working hard to create such an environment. Within the next few months, we are going to recruit 20 more scientists for all our thrust areas. Apart from that we are also trying to affiliate scientists of Indian origin who are working abroad. We just have to make Indian work environment 'hassle-free'. If we manage to create such an environment here, most of the potential work force of Indian origin working abroad in this field may love to come back and give their best to the country. How will you compensate for the vast difference in the compensation package for scientists in India and abroad? There are many of us who love to do those things which we like the most. But there are some who would do the opposite for money. We are trying to draw in all those individuals who want to pursue their dreams which are different from what they are doing at present. To popularize any new technology it is necessary to produce user friendly products.Do you think this will happen in biotech too? As long as we are working in cutting edge technologies, we will help the masses in some way or the other. What we are doing today is definitely going to reach the masses after some years. All the examples of science we have in our house, offices etc were developed long time back. We hope the same thing will happen in biotech also. What projects are in the IGIB pipeline in bioinformatics? We have successfully launched a software 'PL Host' capable of predicting genes function quite effectively. Now we are working on an advanced version. 'Genedecoder' is also another software in the making. It would be capable of identifying new genes. We have another software called 'Seepath' which is capable of identifying bacterial and viral surface adhesins/ antigens which could be useful in drug discovery. What are the expectations of scientists from corporates and the government to make the biotech industry grow? R&D activities at the corporate levels must increase tremendously. The R&D expenditure in the Indian market is much lower than that in other countries. This is the major reason why they have better output than us. We all believe that the future will bring many good results for the industry. As far as the Indian government's efforts are concerned it has initiated many steps to boost biotech long ago. But I am strongly in favor of the government taking steps to remove certain hurdles created by the bureaucracy. And of course the government should stir itself to create a 'hassle-free' environment. What will be the new focus areas of IGIB in this field? Apart from whatever I have mentioned earlier, we are working on discovery genomics and application genomics. At IGIB we also have a lot of programs to create a platform for providing services, training and product development. IGIB 's new building at Mathura Road, New Delhi is also under planning. On the industrial collaboration front, we have a good tie up with Strand Genomics to develop a system biology platform for various diseases. We also have a very good tie up with Pune University in the field of bioinformatics. What is your advice to the young people who want to become a part of this industry? Young people should believe in themselves and work accordingly. Success will only come after a long phase of hard work. They should focus on innovative ideas and new research areas. They have to keep on suggesting new ideas and expand their horizons even when discouraged. Learn to swim against the current if need be. ]]> <![CDATA[First gene-based asthma drug almost ready]]> https://biospectrumindia.com/news/95/2282/first-gene-based-asthma-drug-almost-ready.html https://biospectrumindia.com/news/95/2282/first-gene-based-asthma-drug-almost-ready.html Tue, 10 Jun 2003 20:41:00 +0530 The panel had recommended that the drug's intended benefits may outweigh some concerns about its potential to cause cancer in some patients. In June 2002, Australia's drug regulator had given marketing approvals for Xolair, jointly developed by Novartis, Genentech and Tanox. However, an approval by FDA, one of the world's leading drug regulators, will pave the way for the drug's acceptance in global markets. The FDA panel has restricted the use of Xolair to teenage children and adults mainly due to the non-availability of adequate data for this group now. According to media reports, the recommendation by FDA's advisory panel was among the final steps leading to the formal approval of the drug by the authorities. Though FDA is not bound to accept the panel's recommendation, it has rarely rejected such a committee's advice. A formal approval may happen by June-end. The drug, omalizumab, known by its brand name Xolair, is an immunoglobulin E (IgE)-targeting monoclonal antibody. A complex protein, it works by disabling a naturally occurring antibody called IgE that triggers the release of some chemicals. These chemicals are known to cause inflammation and provoke asthma and allergy attacks. The consortium of companies expect to market Xolair in early 2004 after getting all the approvals. The price of the drug has not been announced. However, analysts expect the full treatment in a year (it may involve injection of Xolair once or twice a month) may cost about $ 10,000 (Rs 5 lakh). According to Genentech, Xolair is the first in a new class of therapies that target IgE in the treatment of an allergic disease. Xolair is designed to inhibit IgE before it has the opportunity to bind to the mast cell, thereby interrupting the cascade of asthma or allergic events. Asthma is a potentially life-threatening chronic inflammatory lung disease. Asthma is often triggered by allergies and is characterized by airway obstruction, wheezing and coughing. Millions of people of all age groups suffer from this disease worldwide every year. In the US alone over 17 million people suffer from asthma including five million children. Additionally, asthma accounts for as many as 500,000 hospitalizations each year. Allergens, such as pollen and mold, and irritants such as dust and tobacco smoke are among the major "triggers" for the breathing problems in asthma patients. Five Phase III clinical trials were conducted to determine the effectiveness of Xolair in asthma (two studies) and seasonal allergic rhinitis (three studies). In the studies, adults (ages 12-75 years) and pediatric patients (approx. ages 6-12 years) were given either Xolair or placebo in conjunction with other medications â€” either inhaled steroids for asthma or antihistamines for seasonal allergic rhinitis (SAR). A study of its impact on perennial allergic rhinitis (year-round allergies caused by allergens such as dust, mold and animal dander) was also done. In the US alone over 17 million people suffer from asthma including five million children. Additionally, asthma accounts for as many as 500,000 hospitalizations each year. Xolair gives a ray of hope to these patients. A Washington Post report said FDA experts were concerned about the data that indicated Xolair may increase the risk of cancer in about 0.5 percent of the patients. The companies said there was no definite link between the drug and the enhancement of cancer in the patients. Most of the various malignancies detected in such cases were solid tumors and most were diagnosed within six months of starting Xolair therapy which suggests they were present before the treatment started. Most tumors develop over several years. Dr Graca Dores, a panel member and fellow at the National Cancer Institute told The Washington Post that there were too few cases to draw a conclusion. "I don't think there's sufficient information one way or another to say Xolair increases risk or does not increase risk of malignancy," she said, adding that Xolair patients should be closely monitored for cancer. "We are impressed with Xolair's magnitude of treatment effect as demonstrated already in multiple US and European peer-reviewed publications," said Btech News, a biotech analyst publication. "Xolair reduces the need for corticosteroids and minimizes asthma exacerbations in atopic ("allergic") asthmatic children. Endpoints of school days lost and unscheduled asthma-related medical visits were significantly fewer in Xolair treated children versus their placebo-treated counterparts. The frequency and severity of adverse events were similar between Xolair and placebo and there were no serious treatment-related adverse events," said the August 2001 electronic issue of the journal Pediatrics. The Journal of Allergy and Clinical Immunology (August 2001) wrote that Xolair both reduces the frequency of asthma exacerbations and decreases the use of inhaled corticosteroid and rescue medication when added to standard asthma therapy. Moreover, Xolair had an adverse effect profile similar to that of placebo. This publication provided confirmation of analogous results for adults published and presented in multiple medical society forums. The Journal of the American Medical Association (JAMA) said, "Xolair significantly reduces symptoms of seasonal allergic rhinitis (hay fever) in patients between the ages of 12 and 75 years old who had at least a two-year history of moderate to severe ragweed-induced allergic rhinitis and baseline IgE levels between 30 IU/mL and 700 IU/mL. Xolair provided a linear dose-response relationship for average daily nasal symptom severity scores." An accompanying commentary by Dr Marshall Plaut of the National Institute of Allergy and Infectious Diseases stressed that many children with allergic rhinitis go on to develop asthma within two to five years and that "it will be important for future research to evaluate whether (Xolair) blocks the onset of asthma." If this proves to be the case, then not only will Xolair be used for the treatment of asthma and hay fever (chronic rhinitis) but also for the prevention of asthma in those predisposed by virtue of their having hay fever. " Xolair treatment effect profiles against other IgE-mediated disorders such as atopic dermatitis and food allergies are also being studied. In multiple studies, Xolair has demonstrated an unequivocally clinically important treatment effect and thus far has demonstrated a reassuring safety profile in both adults and children. The potential blockbuster, a key driver of the monoclonal antibody sector has a considerably greater than average probability of gaining FDA approval," wrote Dr Leon Henderson, Dr Bennett Weintraub and Christopher Martin in Btech news. Analysts expect Xolair sales in the first year to be around $30 million and eventually stabilize around $750 million annually after a few years. N Suresh in Cleveland, Ohio ]]> <![CDATA[The trials leader]]> https://biospectrumindia.com/news/95/6163/the-trials-leader.html https://biospectrumindia.com/news/95/6163/the-trials-leader.html Tue, 10 Jun 2003 20:16:00 +0530 All the hard work done by the company is beginning to payoff. The company was given the first Rabo India Business Award as the "Bio start-up of 2003" for its "pioneering role in clinical development and success in conducting international clinical trials." The award was given during the Bangalore Bio 2003 event in April. "Over the years, our confidence has grown. The confidence reposed in us by international sponsors has also grown manifold. We have conducted clinical trials for several global pharma majors and our study results have been found acceptable for regulatory filings in the advanced countries," said Dr Gautam Daftary, founder and director of SIRO Clinpharm. SIRO is currently conducting clinical trial projects in over 30 hospitals across the country for several clients from Europe, Japan, the US and also India. SIRO has worked for at least 12 Japanese pharma companies and four each from North America and Europe. Analysts said SIRO's client base has grown significantly in the last six years. At least four Indian pharma companies too have used SIRO's services. SIRO's team has 12 medical doctors and an equal number of research students besides some 12 postgraduates in pharmacy working in various divisions. Experts said SIRO is one of the few CROs in India that has the experience to conduct clinical trials to generate data that can be submitted to the US government's Food and Drug Administration (FDA). SIRO has completed some 20 projects so far. These trials are mostly in different areas like oncology, endocrinology, truamatology, sports medicine, pulmonary diseases, pediatric diseases and infectious diseases. Elaborating SIRO's strengths Dr Daftary said, "our capabilities encompass the full range of phase I â€“IV clinical trials. We understand that each client has unique research goals and requirements. Consequently, our clinical trial services can be customized to fit the needs of each particular study. Our clinical trial and management services are conducted under standard operating procedures in accordance with Good Clinical Practice (GCP) as promulgated by the ICH (International Commission on Harmonization of medical trials data)." The company started in a small way in May 1995 when Dr Daftary launched the SIRO Research Foundation as one of the first clinical research organization (CRO) to conduct clinical trials with global standards in the country. Though global pharma companies have been conducting clinical trials abroad for decades, India was not chosen till then for any project. The reasons were mainly lack of experience and training in conducting clinical trails, doubts over data authenticity, inability to maintain confidentiality of data and absence of global standards in the country. Dr Daftary set out to change the perceptions about India and wanted to leverage his personal experience in conducting clinical trials. He tried to build the SIRO Foundation as an independent organization that would follow world class standards in providing clinical trail solutions to large and niche companies across the world. He believed that it was only a matter of time before the global pharmaceutical industry began looking at India as a destination for clinical trials due to the various inherent advantages. It was based on the fact that the success of the software export sector had created a buzz about India as a good place for various activities of knowledge industries. "The business model was risky since there was neither the trained pool of people nor the immediate acceptance of India as a preferred destination. However, our interaction with close business associates in Europe inspired confidence and one European company gave us the first contract even before the formation of SIRO," recalled Dr Daftary about his first experience in venturing into the clinical research area. Later SIRO established its mark by conducting clinical trials for many more clients in a short time. The organization specialized in conducting trials for both efficacy and therapeutic segments. As the activities expanded beyond research services, the name was changed to SIRO Clinpharm in 1997. It started doing high value clinical and analytical work for various clients. It was not just roses all the way. "There were several hurdles which had to be overcome in setting up this innovative venture," recalled Dr Daftary. SIRO had to build up capabilities down the line for conducting high quality clinical trials meeting international standards. This involved creating a core team, training, identifying investigators with the appropriate mindset, training the teams of investigators to meet ICH-GCP standards, assisting institutions in setting up independent ethics committees etc. In short, SIRO had to create the groundwork for all the processes to conduct clinical trials. Similarly, it had to convince international sponsors about the attractiveness of India as a clinical trial destination and in particular SIRO's ability to conduct clinical trials in India which would be acceptable for registrations globally. SIRO is now ready and confident of being a part of the global clinical trial community. SIRO has plans to expand beyond the country's borders and take up similar projects in many other countries. "While we are already a part of the network of organizations conducting global clinical studies, I believe that an association with a global CRO would be the fastest way ahead. At present we are discussing with one of the larger global CROs and are hopeful of inking the agreement in the next few weeks. I believe that SIRO is set to enter a high growth phase in the coming months, " said Dr Daftary. Excited about the growing confidence among the clients about his company and hard work of last eight years now bearing fruit, SIRO is striving hard meet the increased expectations of the global community including investigators, sponsors and regulatory authorities to deliver consistently reliable data on new drugs and medical devices. SIRO believes that it has a significant role to play in the drug development process and it is now looking at several avenues to consolidate and enhance its knowledge and experience to grow globally. Narayan Kulkarni "A billion dollar clinical research opportunity lies in India" Dr Gautam Daftary, a leading authority in new drug development in India is the founder director of Mumbai-based SIRO Clinpharm Pvt. Ltd. After completing his medical education in 1982 he has been working with the pharmaceutical industry and has over 20 years of experience in pharmaceutical management. In an interview with BioSpectrum, Dr Daftary outlined the opportunities offered by the business of clinical trials in India. Excerpts: How do you see the growth of contract research activities in India? India is emerging as a major center for clinical trials as big pharmaceutical companies are working hard to develop new products quickly. A large and diverse patient population, networks of academic and medical centers/hospitals, a big pool of scientists, technicians and doctors are some advantages India offers to these companies. Recognizing this potential, several clinical research organizations (CROs) and multinational companies have already set up facilities for research in India. Clinical research is projected to be a $ 1 billion opportunity for India. Are the global regulations being followed in India? Most teaching hospitals now have well constituted ethics committees that comply with ICH requirements for composition. All trial protocols require approvals from institutional ethics committees before they are initiated. Currently there could be some lacunae in compliance to most of the ICH â€“GCP requirements related to the functioning and standard operating procedures for ethics committees. But a conscious effort is being put in to comply with operational requirements of GCP by many institutions. The investigator usually submits the protocols and consent documents in English and their translated versions in local languages along with other necessary information including the investigator's brochure. Approvals by ethics committees could generally take up to 60 days and occasionally the approvals come even within two weeks. There is no national level ethics committee in India. Some pharmaceutical companies have taken the initiative to form such a committee to facilitate clinical trials by doctors. Do the regulatory mechanisms support the growth of CROs in India? The regulators have recognized the potential benefits of encouraging clinical trials in India. The various steps taken by the government of India including the exemption of customs duty on medications used for trials, various amendments in Schedule Y and release of Indian GCP guidelines are evidence of their good intentions. ]]> <![CDATA[The biotech industry in France]]> https://biospectrumindia.com/news/95/1826/the-biotech-industry-in-france.html https://biospectrumindia.com/news/95/1826/the-biotech-industry-in-france.html Tue, 10 Jun 2003 19:15:00 +0530 ]]> <![CDATA[Global Knowledge Pool for Global Good through Global Funding]]> https://biospectrumindia.com/news/95/2627/global-knowledge-pool-for-global-good-through-global-funding.html https://biospectrumindia.com/news/95/2627/global-knowledge-pool-for-global-good-through-global-funding.html Tue, 10 Jun 2003 19:07:00 +0530 What has brought this issue into sharp focus is the HIV/AIDS case in South Africa. CIPLA offered a cocktail of three anti-retroviral drugs for $ 350 for a treatment for one year, as against the multinational drug pharma companies, whose cost would have been around $10,000. Eventually the companies were forced to bring down the costs to less than $1000. This has raised the issue of availability of medicines at an affordable price to the poor of the world. But another question that arises is also about the necessity of finding ways and means by which drugs of interest to the poor of the world, be it Malaria, TB and so on, could be created. The key question is who will work on these? I wish to propose a model. The famous economist Geoffrey Sachs had proposed that a global fund of $5 to 6 billion be created through which products could be acquired and distributed to the poor. I suggest that the fund could be used also for generation of knowledge. There is a problem about creating the drugs for treating the diseases of the poor. For instance, in 1998 global spending on health research was $70 billion but just $300 million was dedicated to vaccines for HIV/AIDS and about $100 million to malaria research. Of 1,223 new drugs marketed worldwide between 1975 and 1996, only 13 were developed to treat tropical diseases and only four were the direct result of pharmaceutical industry research. It is obvious that there is a pressure on large drugs and pharma companies to provide the maximum value to their shareholders rather than provide value to the poor of the developing nations. Their research portfolio is obviously heavily slanted towards drugs which bring in maximum profits to the firms and not towards the drugs for the poor. Even though there is an orphan drug law, the developed world does not have an incentive to work on diseases which do not affect at least some part of their own population. Therefore, there is no substitute to creating new drugs for the poor through public funding (national as well as international) and also through meaningful public/private partnerships. Can new drugs be developed by public funding? Two issues arise here. First, the track record of the government in commercializing research is generally poor. Second the governments of the developing countries will not have adequate R&D budgets of their own to support research on diseases of the poor, especially tropical diseases. These problems can be circumvented by using successful models like the ones that have been used in agriculture. Agriculture research supported through public funding (both national & international) has given benefits to the developing countries bringing green revolution in several countries. Human Genome project is another example of successful results arising out of public funding. The solution is to create a global knowledge pool for global good through global funding. The global fund should be created and managed by an international body. The funding would be given for creating new knowledge and products for identified diseases of concern to the poor. The research agenda will be set and programs monitored by this body. The norms for sharing the intellectual property arising out of this could be decided in such a way that access at affordable prices to the poor is ensured. There are three ways of funding. The first is to create new world-class R&D centers in countries which have the intellectual capacity to deliver. These centers could be specially fenced, structured and managed. The second is to fund already existing public institutions in developing countries, who have a successful track record and whose performance could be bolstered with additional and directed funding. The third is to create a global knowledge network with partnership between the public and the private organizations. Can such a model work? A number of countries in the developing world have such a capacity to deliver e.g. India, Brazil, China, Thailand etc. Consider, for example, the recent developments in India which is rapidly becoming a global research, design and development platform. Sixty companies from Europe and USA have set-up their R&D Centres in India during the last five years. Recently General Electric (GE), a company with a turnover of $115 billion, setup their R&D centre at Bangalore employing about 1000 Ph.Ds. Jack Welch, the then CEO of GE declared that this was their second largest R&D centre but further plans for expansion have been already approved. The advantage that Jack Welch saw in India was that "the intellectual capital per dollar that was available in India was one of the highest in the world". This is borne out by the fact that India's entire R&D budget in 2001 is slightly less than $3 billion. Contrast this with the R&D budget of a single company such as Pfizer which is about $5 billion. India's great achievements in space, defence, atomic energy, agriculture etc., have been thus made with a budget that is less than that of a single pharma company! The private companies are locating their R&D in India to create proprietary knowledge for private good through private funding. The concept, in contrast, is to create a global knowledge pool for global good through global funding. The interesting challenge, therefore, is as follows. Rather than using the 'spare and expensive capacity' of the large multinational companies to create drugs for the poor, use the capacity of countries which are economically poor but intellectually rich to create drugs for the poor through global funding. RA Mashelkar ]]> <![CDATA[A promising cancer therapy]]> https://biospectrumindia.com/news/95/1864/a-promising-cancer-therapy.html https://biospectrumindia.com/news/95/1864/a-promising-cancer-therapy.html Tue, 10 Jun 2003 17:49:00 +0530 A revolutionary new technology to treat cancer called RNA interference (RNAi) which can selectively deactivate disease-causing genes is making waves in the scientific world. Anila Madiraju, a student at the Marianopolis College, Montreal, Canada, has used this technology successfully to show that it was possible to turn off some cancer causing cells in humans and swept the Intel Science Awards 2003 in a global competition in mid-May from among 1,300 participants from 35 countries. She gets a $ 50,000 (Rs 25 lakh) scholarship to pursue higher studies and a high performance computer. Anila, daughter of Murthy and Padma Madiraju, hailing from Guntur in Andhra Pradesh, was selected one of the top three young scientists in the world by an international panel of judges. Her father is a cancer researcher at a biotechnology company in Montreal. She was also selected for the Seaborg award to attend the Stockholm International Youth Science Seminar and the Nobel Prize ceremonies in 2003. Another student of Indian origin, Anant Ramesh Patel at the Astronaut High School, Titusville, Florida, was the second winner for the trip to Stockholm. Anila has also won two cash prizes in the medical projects category. "I want to do further research on this and help people with cancer," Anila told BioSpectrum minutes after becoming the star of the annual science show. RNA interference ( RNAi) is a phenomenon used by most living organisms as a defense against viral attacks. The process involves the use of "small-interfering" RNAs ( siRNAs) that selectively bind with complementary mRNAs and target them for degradation by inhibiting the proteins required for its growth. Several researchers have shown that synthetic siRNAs can be constructed and used to induce RNAi in human cells. Usually cells in organisms die due to a process called apoptosis. This process is triggered in cells that have completed their lifespan or fulfilled their physiological functions. The proteins that control this process are products of oncogenes. Apoptosis is regulated by the Bcl-2 family of proteins. These proteins contain regions of homologous sequences (BH1, BH2, BH3 and BH4 domains) that play an important role in their function. This family induces pro-apoptotic proteins Bax and Bak (contains BH1, BH2 and BH3) and Mcl-1S, Bad, Bid, Bik etc (these contain only BH3) and anti-apoptopic proteins (Bcl-2, Bcl-X, Mcl-1L, Bcl-w etc) that contain all the four BH domains. In many types of cancers one or more of the anti-apoptotic proteins are elevated which help the cell to escape apoptosis. One such cancer is myeloma whose survival is completely dependent on Mcl-1L. Anila's project targeted this type of cancer. Anila's project used RNAi to specifically alter the Mcl-1L and Mcl-1S levels in cancer cells and test their sensitivity to accept apoptosis. She showed that RNAi could be used to silence and inhibit Mcl-1L protein production which leads to the death of cancer cells. This technology could lead to the development of a therapy to cancer. The advantage of this method is that being target specific, it does not induce side effects observed in chemical compounds used to treat cancer. N Suresh in Cleveland, Ohio What next with RNAi The search for an effective cure against cancer has been going on for decades. In December 2002, the Science magazine named RNAi as the most promising breakthrough of the year. "RNAi is the most important and exciting breakthrough of the last decade, perhaps multiple decades," leading biotechnologist and Nobel-laureate Philip A Sharp told the magazine. Thomas Tuschl, a top researcher at the Rockefeller University, is credited with the development of the RNAi technology. The power of the technology was demonstrated recently by Harvard geneticist Gary Ruvkun. His team identified some 300 genes that regulate the body fat in worms which could be turned off using the RNAi technology. This led to the reduction of body fat in these worms. The counterparts of many of these genes exist in humans and scientists believe that with more research it may be possible to target them for treatment using conventional drugs. What is heartening is the fact that only a small amount of RNAi inducers are required to selectively turn off genes. However, a method to deliver the right amount of the siRNAs directly to the cells may prove to be tricky. Scientists may have to use aerosols to reach the target cells. Because in many experiments in test tubes, compounds that trigger RNAi break down within seconds when they enter the bloodstream. Other experiments with RNAi technology show a lot of promise. Boulder-based Sirna Therapeutics (formerly Ribozyme pharmaceuticals) has shown that it was possible to slow down macular degeneration (a type of eye disease caused by abnormal growth of blood vessels) in rats with some synthesized RNAi compounds. These compounds block the growth of the genes that improve the development of abnormal blood vessels. Buoyed by the success of these studies, Sirna managed to get a $ 48 million venture fund from Oxford Bioscience Partners and Venrock Associates to carry the development further. Though the RNAi phenomenon was first observed in 1830, it came into prominence only in 1998. This was when Andre Fire at the Carnegie Institution of Washington showed that gene-like fragments introduced in small worms called nematodes had formed 'double-stranded RNA". These abnormal versions of RNA molecules resembled closed zippers and triggered RNAi in nematodes. Tuschl's team reported in April 2001 issue of Nature how to make siRNAs. ]]> <![CDATA[Maharashtra setting up biopharma and bioagri parks]]> https://biospectrumindia.com/news/95/1776/maharashtra-setting-up-biopharma-and-bioagri-parks.html https://biospectrumindia.com/news/95/1776/maharashtra-setting-up-biopharma-and-bioagri-parks.html Tue, 10 Jun 2003 17:29:00 +0530 What are your plans to attract biotech companies to Maharashtra? Maharashtra finds itself in a unique position to tap biotechnology, a fast growing industry sector, thanks to the presence of several top international and national pharmaceutical organizations and research centers in the state. The state also has a strong agriculture base. Such a combination should offer tremendous growth opportunities for biotech industries in the state. To fulfil our goal to provide good quality infrastructure, the MIDC plans to set up two parks â€“ one each for biopharma and bioagri at Hinjawadi and Jalna respectively. The project work has been started. Could you give more details about the biotech park? We are developing the pharma biotech park at Hinjawadi which will be spread over 136 acres. The park will focus on attracting organizations from the biopharma sector. Already four companies â€” Emcure (12 acres), Shreya Life Sciences (10), USV (10) and Agarkar Group of Institutes â€” have been allotted land in the park. The Emcure has completed its construction process. Apart from these companies, we are discussing with big firms like Roche, Nicholas, Intas, Lupin and Glaxo to set up their shop at the park. We are looking at around 25-30 biotech companies at this park. We hope its proximity to the Information Technology Park will attract the bioinformatics sector in a big way to the state. We have earmarked about 25 acres of land for an academic center to be set up in collaboration with top global institutions. A unique biotech business facilitation center is also being set up at the park to give a real and determined impetus to the growth of the industry. What steps are you taking to promote the park among potential entrepreneurs? We have appointed The Chartterjee Group (TCG) to promote, develop and market the biotechnology park. The TCG will also work on sourcing investors to set up globally accepted norms such as the good manufacturing practice (GMP) facilities, organize tie-ups with international academic institutions to set up a quality institution within the park, promote tie-ups with multi-lateral agencies and corporates for the development of common infrastructure and to market the park internationally. The state government has a clear policy about allotting land at the park. We don't want entrepreneurs from other industries to avail the incentives being provided to the biotech industry. We ask the companies to prove their biotech initiatives before allotting the land. The park may lose its purity if we provide land to others. What are the special features of the bioagri park? MIDC is also setting up a state-of-the-art complex at Jalna - the seed capital of India - near Aurangabad. We have earmarked 100 acres to develop the park which will provide basic infrastructure facilities. The MIDC will provide land at concessional rate for common research/scientific facilities and for creating an academic center of excellence at the park. We are also planning to develop residential areas with amenities such as school, hospital, clubhouse, shopping complexes etc. to provide comprehensive industrial and social infrastructure at the park. We are very particular about the quality of operations being taken up at the biotech park. We don't want to compromise on this issue. Why was the park located in Jalna? The belt already has the presence of major bioagri companies like Mahyco, Syngenta, Seminis, Monsanto, Mahendra Hybrid Seeds, Nath Seeds, Ajeet Seeds Ltd. These organizations have their production as well as research facilities based there. We are discussing with individuals to set up their shop. We have signed a memorandum of understanding with Maharashtra Hybrid Seeds Company (Mahyco) for the development of the biotech park at Jalna. Mahyco has already set up a biotech center at Dawalwadi near Jalna. The Mahyco Research Foundation (MRF) and its promoters will help in the conceptualization, design and implementation of the park. It will also establish a research facility in the park which can be used by other biotech companies. How do you plan to inculcate entrepreneurship in this area? We know several rich farmers who are ready to invest and wish to become entrepreneurs. They lack proper education. Our main aim is to educate and guide them in a proper manner so that they can set up units to manufacture bio fertilizers, bio pesticides etc. The process has started at Jalna. As agriculture continues to be the backbone of India's rural economy.We want to raise the standard of living of people in such areas by helping them to adapt modern technologies. We have taken up programs to educate and bring awareness about the uses of biotechnology to the rural folk. We have been organizing visual presentations, distribution of handouts, road shows, workshops and seminars at village and taluk level to promote the benefits of agri biotechnology. The program has brought in some awareness among the rural community. Narayan Kulkarni ]]> <![CDATA[Future of life, 50 years after double helix]]> https://biospectrumindia.com/news/95/1017/future-of-life-50-years-after-double-helix.html https://biospectrumindia.com/news/95/1017/future-of-life-50-years-after-double-helix.html Tue, 10 Jun 2003 16:41:00 +0530 The emphasis during the last 50 years of genetic engineering was on reductionism to explain biological phenomena at the atomic and molecular level. The challenge for the next 50 years is to integrate these insights into an understanding of higher levels of spatial and temporal organization and to move on from discovery to invention of better tools and techniques for medicine and health care. From early 2003, scientific communities all over the world have been celebrating the 50th anniversary of the discovery of the double helix structure of the human chromosome by Nobel laureates James Watson and Francis Crick. The completion of the mapping of the human genome had only added an extra zing to the celebrations. At these celebrations, scientists have been thinking aloud about the future too. Scientists have been discussing the various issues threadbare. Many favor continuing of the various research projects while some prefer to give these projects a closer look from the ethical angle. James Watson, the co-discoverer of the double helix structure is emphatic that research should continue because, "we are all interested to know why we are different." Sharing his views on the genetic breakthroughs made in the last 50 years at the Time magazine's Future of Life Summit, Francis Collins, head of the Human Genome Project funded by US Department of Energy said, "the promise for the developing world is quite substantial." Collins predicted that within 10 years, affordable genetic tests for people would be available to identify an individual's risks for certain diseases. With this information, many diseases could be avoided through diet and other forms of pre-emptive treatment. "We are all at risk for something," Collins said adding that within 20 years, powerful drugs derived from the study of the genome would be ready. Dr Paul Nurse, a 2001 joint Nobel Prize winner and chairman of the Royal Society's Science in People's Science Summit program also emphasized that within 20 years it would be technically possible to sequence the genome of each newborn baby and provide him/her with details of every gene and the associated risk of various diseases. The darker side Scientists assembled at the summit also acknowledged the darker side of genetic breakthroughs such as the potential development of genetically engineered bioweapons and genetic discrimination. Without proper public debate and education, some of these developments could lead to 'genetic apartheid' with people being written off by insurers and employers because of some inherited genetic abrnormalities. Another topic of concern was the moral issues related to the work using human embryonic stem cells to develop effective cure against many diseases and cloning. Stem cell research has now become controversial in countries like the US and many groups advocate destruction of human embryos donated by fertility clinics to research centers. Researchers harvest stem cells from these embryos and then attempt to tweak them to exhibit certain desirable traits. Many religious groups feel that life begins at conception and so destruction of embryos was immoral. There were other concerns too such as the possibility of 'genetic divide'. Genomics-based information would dominate the world economy in the next 50 years and only those countries that understood these developments and take advantage of them were going to be the big winners. "Other countries may be left out of the genetic party," summed a leading geneticist. Similarly, there were concerns about the hype over the promises offered by nanotechnology in medicine and the scope for enormous profits from such innovations. Such developments have the potential to deflect people away from seeking preventive measures and shun healthy lifestyles in the hope of instant cure. So scientists have to evolve a balance between the need to take technological developments forward and also ensure that the benefits do no lead to too many moral and ethical dilemmas in the society. Narayan Kulkarni ]]> <![CDATA[SARS: from cats and dogs with love]]> https://biospectrumindia.com/news/95/1837/sars-from-cats-and-dogs-with-love.html https://biospectrumindia.com/news/95/1837/sars-from-cats-and-dogs-with-love.html Tue, 10 Jun 2003 16:33:00 +0530 Two months after the world came to know about the large scale SARS (severe acute respiratory syndrome) infection which started from mainland China, information about its origin has come out. Also, a vaccine against the disease is just ready for trials. However, some experts say the claims about the vaccine are premature. As this debate goes on about the status of the vaccine, what the world now knows with some certainty, is that the SARS virus may have originated in animals like the Himalayan or masked palm civets (a species of cat), raccoon dogs and badgers. Many Chinese consider the meat of these animals delicacies and consume them in large quantities. Blood tests of people who bought these food items in a market in Shenzen indicated that many of them were infected with the SARS virus. However, many of them did not develop the SARS disease. According to Dr Klaus StÃ¶hr, the Geneva-based scientific director of the World Health Organization (WHO) investigation said that a team of virologists headed by Dr Malik Peiris of Hong Kong University tested blood taken from 10 workers in the market and found antibodies to the SARS virus in 50 percent of the cases. The antibodies indicated that their immune systems were triggered by the presence of the virus. Studies on workers in another market in the Guangdong province confirmed the presence of the virus in these animals. However, scientists cannot say with certainty, at this moment, whether the SARS virus has spread to other animals in the wild. If the virus has spread in the wild, then it would become very difficult to eradicate. For identification and destruction all infected wild animals might become a tough task. SARS vaccine Meanwhile, global attention has been turned on a group of doctors at Hong Kong University, Guangzhou Medical College and Fudan University's Shanghai Medical College who claim to have developed a vaccine, the first of its kind, against SARS. The doctors plan to start testing this experimental vaccine on animals in June. Results of the tests on animals would take at least six months. Tests on humans could be done only after animal test results were available. However, some scientists at Hong University have said that the claims about the vaccine were premature. According to a report in The New York Times, scientists said the announcement about the vaccine was premature. What the groups have done, these scientists claimed, was that a strain of nostrils of mice was developed to test how the response system of the mice reacted to the SARS infection. The SARS virus was inactivated with the aim of inserting it in trial animals. "It is an inactivated virus but not yet a vaccine," a scientist said. Doctors and experts at WHO would only confirm that " an attenuated (virulence decreased) virus" which was " non infectious " was ready. Another good news was the decline in the number of reported cases in China. The average daily cases reported had more than halved to six and in May-end, there were in all 5,600 reported cases of SARS and 328 deaths. N Suresh ]]> <![CDATA[News Bytes]]> https://biospectrumindia.com/news/95/1680/news-bytes.html https://biospectrumindia.com/news/95/1680/news-bytes.html Tue, 10 Jun 2003 16:27:00 +0530 Monsanto continues with field trials of Bt cotton After the Genetic Engineering Approval Committee (GEAC) rejected Monsanto India's Bt (Bacillus thuringiensis) cotton variety, MECH-915 for sowing in the northern states, it is making all efforts to continue its field trials of Bt cotton through other hybrids. North Indian companies such as Rasi and Ankur, who have the co-license for Bt cotton will continue to have access to the Bt gene after the trials. Trials are being held in various universities in north India besides the Indian Council for Agricultural Research fields. Tata group eyes biotech for diversification The Tata group is looking at investing in new business ventures like biotechnology and alternative medicine. Still the plans are at an exploratory stage and no firm decision has been taken up on the issue. A report said although biotechnology offers hope for investment, there are several ethical, legal and other issues that complicate the matters for the group. Hence, the Tata's are a bit wary of entering this area. But they are examining the options, according to media reports. Orchid Chem to launch BT products Orchid Chemicals & Pharmaceuticals Ltd is to launch biotech products from its joint venture partner in China, NCPC group's basket in the Indian market. The company will introduce the products in the current financial year. According to K Raghavendra Rao, managing director, Orchid Chemicals, the first phase of the joint venture with NCPC group will be operational in the next six months. The company plans to file eight DMFs (Drug Master File) and four ANDAs (Abbreviated New Drug Application) with the US FDA this year Assocham sees good days for Indian biotech sector The Associated Chambers of Commerce and Industry of India (Assocham) estimated that India will be a major global player in biotech product exports by 2010 with over $4 billion investment finding its way into the country. A paper published by Assocham noted that the demand for existing and new biotech products in India has increased exponentially. Nearly 70 percent of these products were produced through local capabilities and skills and the awareness about availability of such products too has risen. It is estimated that this production will increase to about 80 percent by the year 2005. Molecular Connections enters into alliance with Triesta Hyderabad based Molecular Connections Pvt Ltd, a bioinformatics company, has entered into a strategic alliance with the US-based Triesta Sciences, a clinical genomics company, for biomarker discovery and validation. As part of the alliance, Molecular Connections will provide its advanced information extraction informatics and pathway analysis expertise for Triesta Sciences biomarker discovery program. Anna University to set up biotech center Anna University in Tamil Nadu has created a center for biotechnology with the funds donated by Indian wing of Amersham Biosciences Ltd, the leaders in various products in bioprocess, chromatography, drug discovery and bioinformatics. The biotechnology center would develop R&D activities in the area of drug discovery by creating industry-university interaction. The center would accelerate the conversion of specific scientific results to product development, said E Balagurusamy, vice chancellor, Anna University. ]]> <![CDATA[Ranbaxy for the development of Anti-Malarial drug]]> https://biospectrumindia.com/news/95/1006/ranbaxy-for-the-development-of-anti-malarial-drug.html https://biospectrumindia.com/news/95/1006/ranbaxy-for-the-development-of-anti-malarial-drug.html Tue, 10 Jun 2003 16:23:00 +0530 Ranbaxy Laboratories Ltd is entering into an agreement with 'Medicines for Malaria Venture' (MMV), Geneva, for the development of Synthetic Peroxide anti-Malarial Drug. Ranbaxy's team of scientists will work in collaboration with Scientists and Researchers from the University of Nebraska Medical Centre, Monash University and the Swiss Tropical Institute in identifying a candidate for development. At the World Economic Forum Headquarters in Geneva, Roche, a leading healthcare Company, handed over the role of the "pharma partner" to Ranbaxy Laboratories Ltd. This Synthetic Peroxide Project, voted the "Project of the Year" in 2001 by the Expert Scientific Advisory Committee (ESAC), is one of the principal projects in MMV's current portfolio. Dr Carl Craft, the Chief Scientific Officer of MMV commented that the drug candidates identified so far are showing outstanding anti-malarial activity. Ranbaxy will carry out the development and file an IND (Investigational New Drug), once it has established efficacy and safety in pre-clinical phase. The new molecule should ensure a short treatment period of three days for malaria, and the cost of the product is expected to be much less than the presently being used Artemisinin derivatives, using naturally grown artemisia annua plants. Dr Rashmi Barbhaiya, President, R&D, Ranbaxy Laboratories Ltd, said, "Ranbaxy's alliance with MMV is a manifestation of its emerging profile as an integrated research player. I am confident that this venture will help the world gain from Ranbaxy's research and development skills, as well as allow us to fully leverage our entire span of research and commercial infrastructure." Commenting on the development, DS Brar, CEO & Managing Director, Ranbaxy Laboratories Ltd, said, "Collaborative research is one of the identified growth drivers of Ranbaxy. Developing a new medicine for malaria offers Ranbaxy an opportunity to provide better health care options in this largely neglected segment. We are delighted to join hands with MMV in this venture to enhance our social responsibilities cause." ]]> <![CDATA[Biocon to start clinical trials for diabetic drug]]> https://biospectrumindia.com/news/95/2651/biocon-to-start-clinical-trials-for-diabetic-drug.html https://biospectrumindia.com/news/95/2651/biocon-to-start-clinical-trials-for-diabetic-drug.html Tue, 10 Jun 2003 16:07:00 +0530 The Bangalore based Biocon India Ltd is planning to try out the applications of mycophenolate mofetil, an immunosuppressive drug for the treatment of diabetic nephropathy, a stage wherein diabetic patients end up with renal malfunctions. Biocon is expected to start limited clinical trials soon to try out the extended usage of the molecule in collaboration with the MS Ramaiah Hospital, Bangalore. It has already received the necessary approvals from the Drugs Controller of India and the ethics committee to go ahead with the trials. Mycophenolate mofetil is widely used in organ transplantation to prevent the allograft rejection. It is gaining rapid acceptance on account of its low cytotoxic profile compared with conventional immunosuppressants. Recent studies have indicated that mycophenolate which has a good safety profile could retard the progression of diabetic nephropathy. Biocon India is the only Indian manufacturer which is into this fermentation-derived drug. The trials will be carried out by a group of the medical investigators. Trial results are expected to take 9-12 months. Roche which holds the marketing rights for mycophenolate mofetil, does not have the interest to try out extended usage. Hence, Biocon India has been trying to carry out trials in a small way. It is estimated that diabetic nephropathy affects nearly 30 percent of the diabetics and India has a diabetic population of nearly 32 million. ]]> <![CDATA[Syngenta to set up second plant in India]]> https://biospectrumindia.com/news/95/2479/syngenta-to-set-up-second-plant-in-india.html https://biospectrumindia.com/news/95/2479/syngenta-to-set-up-second-plant-in-india.html Tue, 10 Jun 2003 16:00:00 +0530 Syngenta, the Indian subsidiary of the Swiss biotech major Syngenta Crop Protection has decided to set up a second plant at Goa. This new facility will function as a global sourcing hub for Syngenta Crop Protection. The plant will be engaged in the manufacturing of thiamethoxam, a general insecticide that can be used for most crops in the country including vegetables, rice and cotton. Quoting Pradip Mazumdar, executive director, Syngenta Crop Protection, a report said the market in India will be small for the insecticide in the region of Rs 80-100 crore but internationally it has a huge market potential. The production in India will help to cut the costs significantly. The new plant will serve as an export hub for Syngenta in all the markets whether in the US, Europe, Asia or Latin America. The other plant, also located, in Goa is engaged in the manufacturing of critical intermediates and active ingredients used in plant protection agents including insecticides, fungicides and herbicides. In the insecticides segment Syngenta currently has a stable of seven products including Vertimec, Curacron, Polytrin, Ekalux, Nuvan, Nuvacron and Karate. This particular product was being manufactured in Switzerland for global sales. ]]> <![CDATA[CCMB develops first DNA test to identify animal species]]> https://biospectrumindia.com/news/95/1745/ccmb-develops-first-dna-test-to-identify-animal-species.html https://biospectrumindia.com/news/95/1745/ccmb-develops-first-dna-test-to-identify-animal-species.html Tue, 10 Jun 2003 15:54:00 +0530 p>A team of scientists at the Center for Cellular and Molecular Biology (CCMB) has filed for a US patent for what it claims the world's first DNA test to see if a forensic sample belongs to human beings or animals and also identify the exact species of the animal. According to reports, the new test will be a useful tool in detecting wildlife offences. It has been developed after two years of research led by CCMB director Lalji Singh. CCMB scientists have discovered that nature has hidden species-specific codes of nucleotides or signatures, in a small fragment of a gene, the cytochrome B, present in every mitochondria. The scientists then developed a universal DNA probe to decode the molecular signature from samples and identified the animal species using a data analysis, case management and data capture tool developed by CCMB with the help of Ingenovis, a division of the Srini Raju promoted iLabs. "The database dubbed the Wildlife Tracing Net for Species Signature (WITNess) incorporates in silico analysis of 1,755 signatures currently and another 25,000 are in progress. Ultimately the database will be 50,000 strong," Singh said. ]]> <![CDATA[IGIB launches bioinformatic software`]]> https://biospectrumindia.com/news/95/2883/igib-launches-bioinformatic-software.html https://biospectrumindia.com/news/95/2883/igib-launches-bioinformatic-software.html Tue, 10 Jun 2003 15:52:00 +0530 The GN Ramachandran Knowledge Center of the Institute of Genomics and Integrative Biology (IGIB) has indigenously developed a bioinformatics software called PLHost. The software makes a protein-wise comparison of several organisms simultaneously and assigns functions to the proteins in a short period of time. According to Prof. Samir K Brahmachari, director of IGIB, the software has already been utilized to screen the SARS-virus sequence and has managed to assign functions to about six out of the 11 proteins. Dr RA Mashelkar, director general, Council of Scientific and Industrial Research (CSIR) who launched the software said that the software could help in the identification of potential drug targets. Priced at $1,000 for academic institutions, the software "empowers the small machine" and runs on a Linux-server. He pointed out that it was a sign of the times that the new bioinformatics product has put some of its knowledge out into the public domain while keeping some of its as proprietary information. According to Bramachari discovering functions of proteins based on various tools of comparative genomics is still a challenge in bioinformatics. The indigenously developed software has been patented abroad and has helped to identify 69 new bacterial targets. IGIB has utilized the expertise of Ernst and Young to develop and market the software. ]]> <![CDATA[Siri Technologies enters biotechnology]]> https://biospectrumindia.com/news/95/8221/siri-technologies-enters-biotechnology.html https://biospectrumindia.com/news/95/8221/siri-technologies-enters-biotechnology.html Tue, 10 Jun 2003 15:51:00 +0530 Bangalore-based Siri Technologies has entered the bioinformatics sector and plans to employ over 50 professionals to develop products and services. Announcing this, Srikanth Machkanthi, co-founder and CEO of Siri Technologies said, "we have been looking at this sector for a while and are emphatically convinced that it offers enormous potential and scope for a full-blown IT service provider like us. This would also allow us to leverage the capabilities we had built in-house through our extensive exposure to the life sciences sector. And as far as I could see, the timing is right as the market for product development and services in this sector is just booming." Siri Technologies is a software and consulting services provider and offers a range of services including business and technology consulting, business process and technology re-engineering, custom application development and formal testing. Now the company has diversified its expertise from areas like health care, logistics and embedded systems. The company was recently assessed at Level 4 of the capability maturity model (CMM) of the Software Engineering Institute (SEI) at Carnegie Mellon University and has been awarded the ISO 9001:2000 certification. ]]> <![CDATA[Rajasthan plans Biotech Park]]> https://biospectrumindia.com/news/95/3143/rajasthan-plans-biotech-park.html https://biospectrumindia.com/news/95/3143/rajasthan-plans-biotech-park.html Tue, 10 Jun 2003 15:49:00 +0530 The Rajasthan State Industrial Development & Investment Corporation Ltd (RIICO) has decided to set up a biotechnology park in the state. According to sources, the package has been launched to cash in on the boom in biotechnology. RIICO may offer land at 60 percent discount in designated biotechnology zones to companies having a turnover of over Rs 100 crore. To avail the concession, companies would have to make a minimum fixed investment of Rs 10 crore on the allotted land within four years from the date of allotment. Each company should have at least five acres of land in the biotech zone to qualify for concessional rates. The investor would get an extra discount of 10 percent if commercial production starts within three years from the date of allotment of land. Those wishing to start advanced biotech and bioinformatic educational institutes offering technical graduate and post-graduate courses would be given land at 50 percent of the prevailing industrial rate. Rajasthan has so far not attracted any major biotechnology player. Biotech activity in the state is mainly confined to the University of Udaipur which conducts research projects, University of Rajasthan which offers courses in B.Sc. (biotechnology) and BITS at Pilani which conducts M Tech (Biotech) course. ]]> <![CDATA[Ocimum gets ISO 9001]]> https://biospectrumindia.com/news/95/3338/ocimum-gets-iso-9001.html https://biospectrumindia.com/news/95/3338/ocimum-gets-iso-9001.html Tue, 10 Jun 2003 15:47:00 +0530 Ocimum Biosolutions, Hyderabad,has received an ISO 9001:2000 certificate for Quality Management System (QMS) from Det Norske Veritas, a Norwegian Foundation. To get this ISO certificate Ocimum has implemented a quality management system covering the analysis, design, coding, testing, installation and after sales support of software related to Laboratory Information Management System (LIMS) and bioinformatics. The process approach focuses on business management aspects of an organization while retaining emphasis on traditional software development life cycle processes. "The ISO 9001:2000 certification serves as an impartial and public appraisal of Ocimum's software procedures and products. It also provides us with guidelines to continue in producing the highest-quality bioinformatics and LIMS software," said Anuradha Acharya, CEO, Ocimum Biosolutions. ]]> <![CDATA[Shantha wins tech award again]]> https://biospectrumindia.com/news/95/1485/shantha-wins-tech-award-again.html https://biospectrumindia.com/news/95/1485/shantha-wins-tech-award-again.html Tue, 10 Jun 2003 15:37:00 +0530 Shantha wins tech award again Shantha Biotechnics, the Hyderabad-based pioneers in recombinant biotechnology in India, has won the prestigious fifth National Technology Award â€“2003 for "successful commercialization of indigenous technology" given by the Technology Development Board of the Department of Science and Technology (DST). Shantha Biotechnics won this award for the successful development, manufacture and marketing of the Shanferon, a recombinant human Interferon Alpha 2b. This vaccine is the only indigenous interferon developed, manufactured and marketed by an Indian biotech company. Earlier in 1999 Shantha had won the first National Technology Award, for its Shanvac-B, a recombinant DNA Hepatitis-B vaccine. Shanferon, launched in April 2002, is the only Interferon Alpha 2b to be cloned and expressed in Pichia pastoris, a eukaryotic new generation host having immense advantages over prokaryotic E. coli host. This technology has resulted in a cost-effective product that is very safe and has a lower side effect profile compared to other interferons in the market. With quality comparable to international standards, Shanferon has offered stiff competition to MNC brands. Within a year it has garnered 20 percent market share in a total of Rs 30 crore interferon market and provided an affordable therapy to the masses. Shanferon will help the Indian economy to save foreign exchange due to the low-cost of the indigenous medicine. Shanferon is also being exported to several countries. Shantha has applied for patents for this drug in many developed countries. Shantha plans to launch similar novel recombinant DNA products and vaccines in the near future that conform to international quality standards while meeting the health-care needs of the Indian masses at affordable cost. ]]> <![CDATA[Strand licenses Soochika to BTI, Singapore]]> https://biospectrumindia.com/news/95/2641/strand-licenses-soochika-to-bti-singapore.html https://biospectrumindia.com/news/95/2641/strand-licenses-soochika-to-bti-singapore.html Tue, 10 Jun 2003 15:37:00 +0530 p>Strand Genomics , Bangalore, has licensed its microarray data mining and management product, Soochika to the Bioprocessing Technology Institute (formerly Bioprocessing Technology Center under the National University of Singapore), Singapore. "We firmly believe that its superior data analytic and management capabilities will lead to optimal results and better decisions," said Strand's CEO Srinivasan Seshadri. Soochika employs extensive data cleaning, filtering, transformation and normalization techniques. It has three main analysis pipelines- cluster analysis, predictive model building and differential analysis. Soochika also includes an annotation module that allows the user to pull and organize all relevant information on gene sequences of interest for further analysis. This software is available for both desktop and enterprise wide deployment and runs on Windows, UNIX, Mac OS X and Linux systems. ]]> <![CDATA[India-made typhoid vaccine hits the market]]> https://biospectrumindia.com/news/95/1335/india-made-typhoid-vaccine-hits-the-market.html https://biospectrumindia.com/news/95/1335/india-made-typhoid-vaccine-hits-the-market.html Tue, 10 Jun 2003 15:32:00 +0530 Typbar Vi, a typhoid vaccine manufactured by Hyderabad-based Bharat Biotech International, has been released in the market. This is the first indigenously made typhoid vaccine. Four other companies are marketing typhoid vaccines imported from China, Cuba and Russia. Over 60 lakh cases of typhoid fever occur annually in India. Worldwide, there are over 160 lakh typhoid cases reported annually leading to 600,000 deaths. The fever is caused by the virus Salmonella typhi which thrives in contaminated water and food articles. " The viral strain of Salmonella typhi Ty2 to make the vaccine was made available by Dr John Robbins of the National Institute of Health in the US," said Bharat Biotech chairman and managing director Krishna M Ella. Dr Robbins is the father of polysaccharide vaccine, the family to which Typbar Vi belongs. The vaccine was formally launched by Karnataka chief minister SM Krishna in Bangalore in early May. Typbar Vi is a single dose injectible vaccine. It is being manufactured at Bharat Biotech's world class production facility in the Genome Valley on Hyderabad's outskirts. Company officials said each vaccine dose may cost Rs 175. Efforts are on to reduce the price further to about Rs 100. Bharat Biotech also plans to rope in voluntary organizations, health care agencies and other non-governmental organizations to organize large scale immunization programs in urban areas (mainly slum segments) which were vulnerable to typhoid fever due to unhygienic conditions. ]]> <![CDATA[India's own Monsanto]]> https://biospectrumindia.com/news/95/1682/indias-own-monsanto.html https://biospectrumindia.com/news/95/1682/indias-own-monsanto.html Tue, 10 Jun 2003 14:15:00 +0530 Founded by five scientists, KK Narayanan, Gautham Nadig, Ganesh Kishore, Himadri Pakrasi and Suri Venkatachalam, who had the common vision of harnessing technology to create societal value. They are all biotech professionals. And three of them, KK Narayanan, Gautham Nadig and Ganesh Kishore had worked with the world's leading plant genetics company, Monsanto. In one of their informal meetings, they discussed the idea of making available the latest products and services in the bio agriculture sector at an affordable cost. Soon Metahelix was born. The initial days were tough. The company was formally registered in December 2000, but started functioning only from April next year, initially out of a single bedroom apartment. The business plan focused on improvement of rice, vegetables and cotton with built-in insect resistance, nutritional complements and disease proof properties. While they had ample intellectual capital, funds had to be raised from other sources. They were lucky to spot an " angel investor" in NS Raghavan, former joint MD of Infosys who offered them Rs 6.5 crore in venture capital. With the availability of funds, they moved to a bigger place in VV Puram in South Bangalore. The growth came fast and to accommodate the increasing numbers and facilities required, in late 2002, Metahelix acquired two acres of land at the KIADB Industrial Park in Bommasandra, close to the Electronic City to put up its own lab and green house facilities. It also developed a 15 acre field research farm in South Bangalore to expand the genetic improvement activities. From the start, the company has concentrated on acquiring a revenue stream, in addition to developing its own products and IP positions. Metahelix offers a range of services to both Indian and foreign customers in areas like plant transformation, functional genomics and Life Science informatics. They have some major customers and and it is one of the few companies, which started in the boom period for biotech- 2000-2001 and is running on cash flows. Two of the promoters are today actively involved in running the company. Their individual expertise along with the experience of the other founders is coming in handy in driving up the growth path. Narayanan is a plant molecular biologist and breeder with a doctorate in Plant Breeding and Genetics from the Tamil Nadu Agricultural University at Coimbatore. And then he did post-doctoral research at Stanford University under a Rockefeller Foundation Fellowship. Gautham is a computational biophysicist with a Ph.D. in Molecular Biophysics from the Indian Institute of Science, Bangalore. His postdoctoral work at Pennsylvania State University in the US was in the area of computational quantum chemistry. Now the company is mainly into agriculture based biotechnology. In addition to contract research for several Indian and foreign customers, Metahelix also focuses on trait develoment in crops through genetic transformation, where the returns come only in the long term. Now Metahelix has adopted a novel method of raising working capital for such activities by getting the customer to pay for the product upfront. One such project is in the improvement of cotton and the company expects its product ready for regulatory testing in 2004. The company employs over 40 scientists. As intellectual property will be a key differentiator in this area, Metahelix plans to patent its products. So the company is awaiting the introduction of the product patent regime in 2005 to take full advantage of their technological breakthroughs. As part of a strategic expansion program, Metahelix has also started a seed company, Dhaanya Seeds in December 2002. Roby Ajith "The motivation to improve the system must come from within, not driven by some reward mechanism" KK Narayanan, managing director of Metahelix Ltd., has been on a mission mode to provide rural farmers solutions to some of their urgent problems in the field. A slew of new technologies that could help farmers immensely are being researched and developed in Metahelix. We understand Metahelix has successfully demonstrated some efficient agribiotech practices. Do you plan to extend these practices to other sectors too? Metahelix has gained significant traction in the agribiotech field. However, our long-term vision is to be in other areas of life sciences as well: putting technology to work, to address the needs of a broader section of our global society and creating a discovery engine which focuses on the needs of developing countries. What do you think are the key strengths of Metahelix? The key strength of Metahelix is the people; a set of well qualified and motivated team of scientists who can provide complete research solutions to our customers leveraging our integrated platform of life science informatics and experimental biology. We are always focused on technological solutions and always insist on time and cost efficiency in our research work. We also try to keep the overheads low. What have been the major learnings since you started the company? We started with a strength of five and now we have 40 scientists. Of course, our success to this extent shows that the way we adopted was the correct one. In early 2002, we bought two acres of land at Bommasandra, Bangalore and spent Rs 3 crore on a new building. It was inaugurated on August 14, 2002. We started with an angel funding of Rs 6.5 crore and we are happy about where we are now. We have 15 acres of land in South Bangalore for our plant cultivation and research programs. We started from a single bed room apartment in November 2000 which was borrowed from my friend Gautham Nadig's mother-in-law. Then we moved into the rented place at VV Puram in August 2001. Only in January 2002,we thought about expansion in the Bommasandra Industrial Area. One of the key learnings from our relatively short experience has been that a business model which combines services for the immediate revenues and a longer term product development focus can be a successful one, particularly in the Indian context. What are your current expectations? The going has been good so far and we hope to continue to do well. We hope to be one of the top agri biotech companies in the next five years. How do you foresee the future of GM crops? In 2002, GM crops were cultivated globally in some 56 million hectares of land. To put this in perspective, it is an area larger than many countries and is only a little under one-fifth of the area of our country. You know, in 1996 it was only 1.7 million hectares. So that's a big transformation within six years. I do not know of any other technology in the history of agriculture that has grown at such a rapid pace and I am sure this global trend will continue. Further, this technology holds great promise, particularly for an agrarian economy like India. Let me emphasize that responsible use of medern biotechnologies in agriculture is definitely good for our country. We believe that it is important to make the fruits of the most recent developments in life sciences accessible to the Indian farmers through appropriate pricing. These technologies have to be added on to the best available crop varieties or hybrids so that there are significant incremental benefits to the growers and consumers. We would work towards providing the latest and the best technological solutions so that the Indian farmer can make better choices. Does hierarchical position of the company matter in terms of sharing of information? No, we are a relatively flat organization. We believe in team work and encourage everyone to speak out. This is the only way we can harness the creative potential of our highly skilled personnel. While we take our work very seriously, we also ensure that all our employees enjoy coming to the workplace and have fun working there. I am of the belief that in a scientific organization like ours, the motivation to improve the system must come from within, not driven by some reward mechanism. ]]> <![CDATA[Bioinformatics: wave of the future]]> https://biospectrumindia.com/news/95/3058/bioinformatics-wave-of-the-future.html https://biospectrumindia.com/news/95/3058/bioinformatics-wave-of-the-future.html Mon, 09 Jun 2003 15:12:00 +0530 Bioinformatics: wave of the future Everyone is now talking about bioinformatics. This is the new segment created by the merger of two hot areas: information technology and biotechnology. So this has become one of the most promising field for job hunters. What are the opportunities available in this field? Bioinformatics is the application of computer technology to the management of biological information. It combines computer science with biology and genetics with a good-sized dollop of mathematics, statistics and other medical specialties thrown into the mix. Computers are used to gather, store, analyze and integrate biological and genetic information which can then be applied to gene-based drug discovery and development. Bioinformatics is not just a useful tool in biological research or drug development. It is an indispensable ally of researchers. "The technology is versatile and can be applied whenever gene, protein and cell research are used for the discovery of a new drug or a new herbicide/herbicide-resistant crop combination. Drug toxicology, pharmacogenetics and clinical trial studies can also benefit from this technology which can even be used to genetically engineer crops and livestock that have enhanced nutritional qualities and the ability to produce pharmaceuticals," said Anuradha Acharya, CEO, Ocimum Biosolutions, Hyderabad. Recent years have seen an explosive growth in biological data. It should be managed and stored for various purposes. Also the managed data should be in tune with the current times. Here comes the relevance of bioinformatics. Large sequencing projects are producing increasing quantities of nucleotide sequences. The contents of nucleotide databases are doubling in size approximately every 14 months. Without bioinformatics, new research in most fields of medicine and biology would come to a standstill. The explosion of publicly available genomic information resulting from the Human Genome Project has precipitated the need for bioinformatics capabilities. The enormous growth of biological data led to the development of several things. First, all these data need to be stored. The second requirement is the need for radical new methods for analyzing these huge databases. Thirdly, powerful hardware is required to carry out the task of analyzing these databases. For instance, IBM is giving away free Web services technology to help scientists to track down DNA as the company continues its push itself into the promising life sciences arena. The latest release of GenBank (V.102) exceeded one billion base pairs. Not only the size of sequence data is rapidly increasing but also the number of characterized genes from many organisms and protein structures doubles every two years. To cope with this great quantity of data, a new scientific discipline has emerged: bioinformatics, biocomputing or computational biology. How to become a bioinformatics expert? Bioinformatics combines the tools and techniques of mathematics, computer science and biology in order to understand the biological significance of a variety of data. So if you like to get into this new scientific field you should be fond of these 'classic' disciplines. Because the field is so new, almost everyone in it did something else before. Some biologist went into bioinformatics by picking up programming but others entered via the reverse route. Eligibility: B.Sc/M.Sc (Microbiology/Biochem/biotechnology/Agriculture/Horticulture/Seri/Food Technology/Organic Chemistry/botany/zoology/statistics/bio science & other divisions of life sciences, BE/B.Tech/B.VSc/M.VSc/B.Pharma, MBBS/BDS. · National biotech institutes Chandigarh The Institute of Microbial Technology, Chandigarh New Delhi The National Institute of Immunology, New Delhi IGIB, New Delhi Hyderabad The Center for Cellular and Molecular Biology, Hyderabad Centre for DNA Fingerprinti- ng Technology, Hyderabad Bangalore The National Center for Biological Sciences, Bangalore The Jawaharlal Nehru Center for Advanced Scientific Research, Bangalore As a biologist, what skills do I need to make the transition? In addition the extensive knowledge of the run-of-the mill molecular biology packages (GCG, BLAST etc.), you will need to learn web and programming skills including HTML, Perl, JAVA and C++ and be familiar with a variety of operating systems (especially UNIX). Relational database skills are very much sought after. So knowledge of SQL and a major database application such as Sybase or Oracle will be highly advantageous. One area of bioinformatics that is set to expand is the determination of relationships between structures and sequence. If you wish to enter this field, you will need to learn all you can about structural biology and modeling, mathematical optimization, computer graphics theory and linear algebra. Is it easier to move from biology to computers or the reverse? The answer depends on whether you are talking to a computer scientist who 'does' biology or a molecular biologist who 'does' computing. Most of what you will read in the popular press is that the importance of interdisciplinary scientists cannot be over-stressed and that the young people getting the top jobs in the next few years will be those graduating from truly interdisciplinary programs. However, there are many types of bioinformatics jobs available, so no one background is ideal for all of them. The fact is that many of the jobs available currently involve the design and implementation of programs and systems for the storage, management and analysis of vast amounts of DNA sequence data. Such positions require in-depth programming and relational database skills which very few biologists possess and so it is largely the computational specialists who are filling these roles. This is not to say the computer-savvy biologist doesn't play an important role. As the bioinformatics field matures there will be a huge demand for outreach to the biological community as well as the need for individuals with the in-depth biological background necessary to sift through gigabases of genomic sequence in search of novel targets. It will be in these areas that biologists with the necessary computational skills will find their niche. Companies which are into Bioinformatics GVK BioSciences Pvt. Ltd                   Hyderabad Strand Genomics                                   Bangalore AstraZeneca                                          Bangalore Dr Reddy's Laboratories                       Hyderabad Ingenovis (division of I labs)                   Hyderabad Jubilant Biosys (subsidiary from Jubilant Organosys)                                Noida, UP Landsky Solutions                                  Secunderabad Molecular Connections                           Bangalore Ocimum Biosolutions                              Hyderabad PrayogNET Computing                          Chennai Questar Bioinformatics                           Hyderabad Satyam Computers                                 Hyderabad Spectramind Services                             New Delhi Total Consultancy Services                     Hyderabad   The Scope As geneticists, microbiologists and other researchers continue to gather huge amounts of new information about the human genome and biological molecules, there is a growing need for sophisticated, computerized approaches for compiling and analyzing that data. The process by which that is done is called bioinformatics. Every major university in the world is trying to get its share in this field. There is a great scope for Bioinformatics in India. Companies have to work hard to gain respect and credibility. Bioinformatics hasn't and cannot create a million jobs like IT as it is only a subset of IT. The numbers will increase but in small percentages. "I wouldn't advice everyone to jump into this field as it would only dilute the market with excess supply of professionals. On the other hand, it might be good for companies as it would give us enough people to choose from", said Ocimum's Anuradha. Another observation was that for a Bioinformatics company which hires 100 people, about 70 percent are people with core knowledge with some understanding of bioinformatics. The number of people with bioinformatics resumes have increased rapidly but the quality of these "professionals" hasn't. "Companies like us are always looking for good people but it takes us, on an average, 100 shortlisted resumes to finally pick one qualified person," she added According to Rajendran, Sr. Executive - Business Development, BrainWave Bioinformatics Ltd, a lot of universities and institutes are into bioinformatics. Almost every university in Andhra Pradesh and Karnataka offer a diploma in Bioinformatics. The prominent ones are the University of Hyderabad, Osmania University, IICT, IIIT. Many private institutions which started during the hype have shut down. There are very good universities like the University of Pune, Madurai Kamaraj, Bose Institute and Jawaharlal Nehru University. The IIT's at Kharagpur and Delhi also have a very good biotechnology department. A lot of IT companies like TCS and Infosys have ventured in to this area but most of them do not have very large teams. Many large companies and research institutions are hiring hundreds of bioinformatics professionals. "Bioinformatics as a career is very lucrative and has a great future. Requirement from an individual is the ability to contribute either in life sciences or in IT when working in a team comprising of professionals from both fields. Typical qualifications would be Masters and Ph.D. The salaries are benchmarked against industry standards and would be comparable with any other industry including IT. The sector is growing at an impressive rate and companies which understand the 'real issues' of the industry will only survive in the long run. Working with such companies will result in overall development for professionals in this sector," says Sowmya Narayan of Strand Genomics. According to Dr GPS Raghava, Scientist & Co-ordinator of Bioinformatics Centre, Institute of Microbial Technology, Chandigarh, there is a big gap between the demand and expertise available. The gap is not only in India but in the US also. Despite the hype and the presence of large number of bioinformatics training centers in India our contribution is too limited. Other useful areas Bioinformatics is today seen as primarily applied to speeding up new drug discovery. But the other area that assumes increasingly higher significance is the application of IT to the entire life sciences sector- for the same purpose it is done in other industrial sectors- improving efficiency, reducing costs, wider access, etc. For example bio-diversity data management is an area that requires application of the best database design techniques and planning for data warehousing and data-mining. Knowledge management as applied to corporations will also become relevant in the scientific context to ensure that Indian scientists get relevant and timely information related to their research to help them network and collaborate to create new intellectual property. "There may be around 200-300 employed in this sector every year. There are a lot of private institutions getting into the foray, but then quality is indeterminate," said Rajiv Vasudevan, who is an expert both in IT and biotechnology. Bioinformatics in India is at an early stage of development. But at 4 to 5 centers in the country, one sees mature understanding of the needs of this sector and world class development of tools and applications. These centers will ensure that India's traditional strengths in IT are leveraged to place us on par with the developed countries. Roby Ajith   ]]> <![CDATA[How SARS spread its tentacles worldwide]]> https://biospectrumindia.com/news/95/2867/how-sars-spread-its-tentacles-worldwide.html https://biospectrumindia.com/news/95/2867/how-sars-spread-its-tentacles-worldwide.html Wed, 21 May 2003 19:57:00 +0530 In retrospect, it has now emerged that an outbreak of a similar illness in Guangdong Province in Southern China which started in November 2002, was the start of SARS. It is a new viral infection that hundreds of scientists around the globe are working on. SARS is a respiratory illness that has recently been reported in Asia, North America, and Europe. Dr Carlo Urbani, the WHO (World Health Organization) scientist first alerted the world to the existence of SARS in Hanoi, Vietnam. While checking about the illness, he too contracted it and died in Bangkok hospital on March 29. The signs and symptoms in infants and children may not follow the exact pattern that is seen in adults. Consequently, doctors are on the lookout for atypical forms of presentation in very young infants. In adult patients with SARS, there is usually a fever, which may be accompanied by chills and other symptoms such as headache and general body aches. In the early stages of the illness, patients may have these nonspecific symptoms (headaches and general body aches). In addition to these symptoms, SARS may be associated with other symptoms including loss of appetite, malaise, confusion, rash and diarrhea. Severe respiratory illness may occur before abnormalities are noted on chest X-rays. At the outset the illness may be very mild. Scientists have concluded that the virus belongs to the coronavirus family which is mostly known to cause cold or mild pneumonia. The virus family is known after its crown-like shape of the surface. A coronavirus is transmitted from person to person by droplets. When the sick person coughs or sneezes, the virus can be carried in saliva droplets to people nearby and infect them. The incubation period for SARS is typically two to seven days; however, isolated reports have suggested an incubation period as long as 10 days. The illness usually begins with a fever (100.4°F [38.0°C]). SARS infected person gets a high fever accompanied by cough in Stage I. Respiratory distress may occur in Stage II. In Stage III, the patient may go into an acute respiratory distress syndrome and may die. The patient could also have shortness of breath or other breathing problems and a dry cough. Some people may get a headache, stiff or achy muscles, a loss of appetite, fatigue and diarrhoea. The epidemic has so far infected 4,000 people and killed at least 250. SARS originated in mainland China. While cases there may be declining, according to health officials, they seem to be on the rise in far-apart places like Hong Kong and Canada. A few cases have been reported in India too from people who had apparently picked up the infection during travel in the affected areas of Asia. It is a disease caused by a virus and, therefore, antibiotics are not effective. The British Medical Journal says steroids and the antiviral agent, ribavirin, have been tried but their efficacy remains unproven. The National Institute of Communicable Diseases says the only possible treatment is medicine for fever and syrups for cough relief. WHO says about 3 per cent of those infected have died. It seems that close contact with someone who has it is necessary. A large number of people who have contracted SARS so far have either been hospital workers or members of a victim's family. Scientists have offered several explanations for why SARS has turned deadly. An unknown human coronavirus could have undergone some mutations and changed its genetic makeup. Or an animal coronavirus could have mutated before jumping to humans. The new findings suggest that the SARS virus probably underwent natural mutations. While the DNA sequencing does not establish the source of the virus, it is believed to have come from livestock. How it entered humans is not known. Scientific Details Bronchial tissue from a victim of SARS in Toronto was grown in Vero cells (African green monkey kidney cells) in order to reproduce the ribonucleic acid (RNA) of the disease causing coronavirus. In a process known as 'reverse transcription,' the team made a DNA copy to be used in a biochemical reaction. The Centers for Disease Control and Prevention (CDC) announced that it has sequenced the genome for the coronavirus believed to be responsible for the global epidemic of severe acute respiratory syndrome or SARS. The CDC sequence is nearly identical to that determined by a Canadian laboratory. The significant difference is that the CDC-determined sequence has 15 additional nucleotides, which provides the important beginning of the sequence, CDC scientists said. All of the sequence, except for the leader sequence, was derived directly from the viral RNA. The genome of the SARS coronavirus is 29,727 nucleotides in length and the genome organization is similar to that of other coronaviruses. Members of this viral family tend to have between 29,000 and 31,000 nucleotides. Open reading frames corresponding to thepredicted polymerase protein (polymerase 1a, 1b), spike protein (S), small membrane protein (E), membrane protein (M) and nucleocapsid protein (N) have been identified. Dr Steven Jones, head of bioinformatics at the Genome Sciences Centre, Canada, says the virus detected appears to be a new type of coronavirus bearing only modest similarity to those coronaviruses previously characterized. 'The next step for the Genome Sciences Centre is to analyze the proteins that the virus produces, to try and find clues for why this is such a virulent pathogen. Treatment At present, the most efficacious treatment regimen, if any, is unknown. In several locations, therapy has included antivirals such as oseltamivir or ribavirin. Steroids also have been given orally or intravenously to patients in combination with ribavirin and other antimicrobials. In the absence of controlled clinical trials, however, the efficacy of these regimens remains unknown. Early information from laboratory experiments suggests that ribavirin does not inhibit virus growth or cell-to-cell spread of one isolate of the new coronavirus that was tested. Additional laboratory testing of ribavirin and other antiviral drugs is being done to see if an effective treatment can be found. Scientists around the globe are trying to get to the depth of this problem and to find a permanent cure but by the time the problem is fixed there may be many more innocent victims of SARS. We hope an effective test procedure and treatment is discovered at the earliest. Anna Susan Jacob Country Cumulative number of case(s) Number of new cases since last WHO update Local chain(s) of transmission Number of deaths Number recovered Date of last report Australia 3 0 0 3 None 17-Apr-03 Brazil 2 0 0 0 None 16-Apr-03 Canada 132 0 12 54 Yes 19-Apr-03 China 1959 447 86 1187 Yes 21-Apr-03 China, Hong Kong Special Administrative Region 1402 44 94 436 Yes 21-Apr-03 China, Taiwan 29 0 0 17 Yes 18-Apr-03 France 5 0 0 1 None 21-Apr-03 Germany 6 0 0 4 None 21-Apr-03 India 1 0 0 1 None 21-Apr-03 Indonesia 1 0 0 0 None 19-Apr-03 Italy 3 0 0 2 None 21-Apr-03 Japan 5 1 0 0 None 21-Apr-03 Kuwait 1 0 0 1 None 20-Apr-03 Malaysia 6 1 1 0 None 21-Apr-03 Mongolia 3 0 0 3 None 17-Apr-03 Philippines 2 1 1 1 None 21-Apr-03 Republic of Ireland 1 0 0 1 None 21-Apr-03 Romania 1 0 0 1 None 21-Apr-03 Singapore 178 1 16 104 Yes 20-Apr-03 South Africa 1 0 0 0 None 9-Apr-03 Spain 1 0 0 0 None 21-Apr-03 Sweden 3 0 0 0 None 21-Apr-03 Switzerland 1 0 0 1 None 21-Apr-03 Thailand 7 0 2 5 None 21-Apr-03 United Kingdom 6 0 0 5 Yes 21-Apr-03 United States 39 NA 0 NA Yes 21-Apr-03 Viet Nam 63 0 5 46 Yes 17-Apr-03 Total 3861 495 217 1873 Cumulative number of reported probable cases of Severe Acute Respiratory Syndrome (SARS) ]]> <![CDATA[Biotech success in India]]> https://biospectrumindia.com/news/95/1388/biotech-success-in-india.html https://biospectrumindia.com/news/95/1388/biotech-success-in-india.html Mon, 19 May 2003 19:36:00 +0530 a)Genetic Engineering: Unfortunately, we haven't, totally on our own, produced a single genetically modified organism of commercial value, even though we have had enormous capabilities to do so. We have increasingly done well in the last decade in the direction of producing useful protein drugs using genetically engineered microorganisms grown under highly confined conditions. The first product to be produced in this manner was Hepatitis B vaccine, Shanvac-B, by Hyderabad based Shantha Biotechnics Pvt. Ltd. The product came in the market in 1997. Shantha Biotech invested Rs 16.5 crore for bringing out its first product Shanvac-B. It now has a pipeline of products on the anvil. In fact, Shanferon (Interferon alpha 2b), its second product is already in the market, and another product, Human Insulin, should be in the market by next summer. Other producers of Hepatitis B vaccine, such as Bharat Biotech and Wockhardt have followed Shantha Biotech. Wockhardt, on the other hand, is now also producing Erythropoietin through genetic engineering. In the area of protein drugs produced through genetically engineered microorganisms, we are poised to witness an exponential growth in the country based totally on our own expertise with new players constantly joining in the run. What one would like to see in the area, in national interest, is the new players producing products that are not so far produced (or not planned to be produced in the immediate future) by the existing players. b)Enzyme technologies: We have done well in the enzyme technologies. The leadership is being provided by Biocon of Bangalore under the stewardship of Dr Kiran Mazumdar Shaw, and Bangalore Genii, a pioneering and highly successful company set up by Dr P Babu, who left a successful and lucrative career in Molecular Biology to do so. c)DNA technologies: Amongst various DNA technologies, India has provided outstanding leadership in the field of DNA fingerprinting. This is probably the most publicized technology in the area of modern biology developed in the country. I will, therefore, not say anything more about it except that the credit for the development of this technology that has already brought immeasurable social benefit to the country, goes to Dr Lalji Singh, the present director of the Center for Cellular and Molecular Biology (CCMB) at Hyderabad ( Shantha Biotechnics Hepatitis B vaccine was also developed at the CCMB). Today in India, we also have a large number of laboratories (both in the public and private sector) with facilities for high throughput sequencing which would allow us to sequence genomes. Pushpa M. Bhargava, one of India's most brilliant scientists, has founded and directed the Centre for Cellular and Molecular Biology (CCMB), Hyderabad.His scientific contributions include the preparation and characterization of primary liver cell suspensions, identification of proteins from the seminal plasma and extensive characterization of one of these proteins and seminalplasmin. He has been awarded with Padma Bhushan, the Legion d' Honneur, the Wattumul Memorial Prize and Goyal Prize. Companies such as Avesthagen set up by Dr Villoo Morawala-Patell in Bangalore, also have a high level of expertise in the development of new molecular markers for plant identification and characterization for commercial purposes. DNA-based probes for diagnosis of certain inherited disorders are already being used in the country, though there is no organization yet that would produce these probes commercially. d)Assisted Reproductive Technologies (ART): Over the last ten years, there has been a mushrooming of infertility clinics which claim to have therequired facilities for artificial insemination using husbands' or donors' semen, in vitro fertilization, intra-cytoplasmic sperm injection, and techniques involving egg donation and surrogate motherhood. This explosion of infertility clinics in the country has led to an immense variation in the quality of service provided, from outstanding to extremely poor. This situation led the Indian Council of Medical Research to prepare guidelines for accreditation and supervision of infertility clinics in the country. These guidelines have been debated around the country and now await appropriate legislation by the Government of India that would make the finalized guidelines mandatory. What is satisfying is that India is, by and large, at par with the rest of the regard to ART. e)New drug delivery system: Some of the leading drug companies in India such as Sun Pharma and Shantha Biotech have been actively involved in developing and marketing new formulations which would make the intake of the drug more convenient and effective. f)Marine biotechnology: The first company in the country totally devoted to marine biotechnology is Shantha Marine. The company is in the production of its first marine biotech product, Beta-carotene made by using marine algae. The product is already in the market. The expertise in this area in the country is of a very high order and, perhaps, comparable with the best anywhere. g)Rational drug design: Dr Reddy's Laboratories in Hyderabad discovered a new anti-diabetic drug for the first time in the country using the rational drug design approach. The drug is now under clinical trials. There are other major pharma companies (Such as Ranbaxy and Sun Pharma) in the country that are engaged in new drug discovery using rational drug design based on advances in biotechnology and modern biology. In the area of protein drugs produced through genetically engineered microorganisms, India is poised to witness an exponential growth based totally on our own expertise with new players constantly joining in the run. h)Probiotics: There are several companies in the country making probiotics, such as Actobacilli, as Over-the-Counter (OTC) drugs. One of them, Microbax, located in Hyderabad, is exclusively devoted to the production of such probiotics. i)Bioinformatics: There has been a great upsurge of activity in the area of bioinformatics in the country, in the research going on in both educational institutions and in industry. The bioinformatics group of an information technology major in the country has already identified a promising target for the development of a new drug against a most common disease in India. Let us finally, look at the emerging areas in biotechnology, which have not yet been commercialized, and see what our country is doing in these areas. (1)Stem-cell research: Fortunately several major basic research laboratories in the country as well as commercial organizations are investing substantial time, energy, effort and resources in stem-cell research area. The ultimate objective of this area is being able to grow the desired organs in vitro to take care of the organ transplantation needs of the people. Some of these institutions are the CCMB in Hyderabad, the National Center for Biological Sciences in Bangalore, and the National Center for Cell Science in Pune. Reliance Life Sciences, it is believed, is also investing heavily in this area. (2)Increasing Photosynthesis efficiency: Unfortunately, virtually no significant work is being done in this area in the country. (3)Certain DNA technologies: We have not so far made any investment whatsoever in the development of DNA- based computers, the foundation of which was laid in 1994, when the well-known travelling salesman problem was solved using DNA computing. Since then, an enormous amount of effort has been put in, in this area of several countries, including Israel. We also do not have any investment today in developing antisense technologies.   The ultimate objective of the stem-cell research area is being able to grow the desired organs in vitro to take care of the organ transplantation needs of the people.   (4)Use of phenomenon like circadian rhythms in developing individualized medicine: Although there has been at least one groupâ€”that of Dr MK Chandrashekar at Madurai (now in Bangalore)â€” that has done outstanding work on circadian rhythms in certain animals. There has been, however, very little work done on circadian rhythms in human beings that will allow us to design individual-specific drug delivery protocols. Similarly, there is very little investment in the country in looking at certain promising new drug delivery systems such as electrical patches. (5)Vaccination using DNA: There is, fortunately, at least one group- at the Indian Institute of Science, Bangalore- that has been working in this area but we need expansion of research and development in this very promising field. (6)Nanobiotechnology: We haven't really made a beginning so far in this area which has immense promise in developing new and viable protocols for drug delivery, enzyme immobilization and DNA transformation. What I have said in this and the preceding article is that we are trying to be there; we have enormous assets but we have to expand our activities in a focussed manner and use all the assets we haveâ€”human, infrastructural, natural, and financialâ€”to the best of our advantage. For this we would need to set up systems of cooperation between the various playersâ€”biotech industries in both the public and the private sector, the financial institutions and the venture capitalists, the national laboratories under the various agencies and the departments concerned of the Government. Each member of these various sectors will need to learn, to speak and interact with each other to optimize their collective output in their interest and in national interest. As of today, virtually all the efforts are in the private sector with little dialogue between the various players in this sector. There is no public sector biotechnology company in the country, even though the Department of Biotechnology was set up in 1986 precisely for this purpose. We need to have investments in biotechnology in the public sector, for what a public sector company in biotechnology can do, a private sector company cannot, and vice-versa. We should remember that the status of industry in the country in the private sector would not have been what it is, had it not been for the investment by the government in the core sectors. Certain areas in biotechnology must be regarded as belonging to such core sectors. PM Bhargava ]]> <![CDATA[Habil Khorakiwala - Wholly dedicated to life sciences]]> https://biospectrumindia.com/news/95/5718/habil-khorakiwala-wholly-dedicated-to-life-sciences.html https://biospectrumindia.com/news/95/5718/habil-khorakiwala-wholly-dedicated-to-life-sciences.html Mon, 19 May 2003 19:17:00 +0530 "Wealth in the new regime flows directly from innovation, not optimization; i.e., wealth is not gained by perfecting the known, but imperfectly seizing the unknown." - Kevin Kelly says in his book New Rules for New Economy This is what Habil Khorakiwala, chairman and managing director, Wockhardt Ltd believes in. Often described as soft-spoken, friendly and accessible, he is the man behind the success of Wockhardt. Habil is the eldest son of businessman Fakhruddin Khorakiwala, who is the chairman of the Mumbai based Akbarally's chain of departmental stores. After majoring in a pharmacy course from LM college, Ahmedabad, he acquired a masters degree in pharmaceutical science from the Purdue University, USA. In the sixties, his family bought a small pharma company in Mumbai called Worli Chemicals Works, which manufactured medicines for common ailments. He took over the reins of the company after his return from USA and changed the name to "Wockhardt", which means "work hard" in German language. Armed with a good education in pharmacy and management (he did an Advanced Management Program from the Harvard Business School), Habil Khorakiwala with confidence strode ahead with his ventures. When he took over the reigns of Wockhardt in 1966, it's turnover was just around Rs 4 lakh with 20 employees on its rolls. Since then, under his stewardship, Wockhardt has grown to become one of the three Indian pharmaceutical companies considered truly global players with a multi-disciplinary R&D program, quality products and international alliances and joint ventures. Today, Wockhardt is doing business ranging from the manufacture and marketing of pharmaceutical formulations, bulk drugs, vaccines, medical nutrition and animal health. It is mainly because of the dedication, sincerity and stewar- dshipness of Habil Khorakiwala, Wockhardt has made it big in four decades, from a turnover of Rs 4 lakh in 1966 to Rs 742 crore in 2002. It grew by 14 percent in 2002. It made a net profit of Rs 109 crore, up 6.6 percent compared to the previous year. Now Wockhardt is one of the country's leading healthcare organizations, serving the medical community as a pharmaceutical and research-based organization. Considering Habil's achievements, the Institute of Marketing & Management has honored him with award for 'Excellence as Top CEO' for the year 2002. Khorakiwala expanded his company's business operations to UK, employing over 2,500 people in eight plants and nine offices worldwide. At present the company's products are available in over 90 countries across the globe. "Our R&D efforts have resulted in import substitution of various high value bulk drugs as well as formulations.We have strategically invested about Rs 200 crore in the past fiveyears"says Habil Khorakiwala, chairman, Wockhardt Ltd. Signature style management approach 'Customer focused' is his advocacy. He strongly believes that it is the way towards a faster growth. This customer-centric approach has filtered down to every decision and action in Wockhardt. His signature style is much evident in the management processes at Wockhardt. Open culture, participatory management practices, innovations, continuous improvement, speedy response, empowering individuals and enjoying one's job - are all hallmarks of Wockhardt's culture. Apart from that, he considers human capital among the most valuable assets for any company. He says, "the proactive reviews, policies and process will attract and retain the substantial pool of scientific, technical and managerial resources through a work environment. This approach encourages initiatives, provides opportunities and recognizes the performance and potential of its people through a judicious mix of incentives, performance bonus and grant of stock options." His style of approaching the new ideas, handling the problems and implementation of the ideas fetched him The Indian Analytical Instruments Association's LifeTime Achievement Award. He has also received the Shiromani Vikas Award for his 'outstanding and inspiring contribution towards national development' in 1992, at the hands of the late Nobel Prize laureate Mother Teresa. Dream coming true Habil has a dream of making Wockhardt the most admired pharmaceutical company in India. His vision had showed him the doors of biotechnology at a time when it was not a fashionable area to be in. Habil's plans of developing Wockhardt as a specialist drug company in the domestic market and a producer of biogenerics globally saw some restructuring in the company. The firm restructured, spinning off its parenterals division into a separate company, and a nother company called Wockhardt Life Sciences was formed. This brought in a shift in the product portfolio of the company dominated by low margin acute therapy products towards biotechnology and high margin products. The focus was shifted to chronic therapies, mainly biotech products in diabetes and oncology with a thrust on vaccines and generics with delivery based products. And it has developed the ability to construct genes and express them in various systems. Wockhardt became the first major pharma company in India to make a move in biotechnology, and focussed on new drug discovery and novel drug delivery systems. Khorakiwala says, "a biotech drug has no chemical substitute. Biotechnological products are in a much better position to establish the kind of therapeutics that are required. There is no treatment in those areas. So that time it appeared to me that in 10-15 years it was going to become more and more important. That is what is happening now. " Over a period of time Wockhardt emerged as a front runner in the biotechnology revolution with the indigenous research and a range of biotechnology products, backed by a big marketing and sales team. Apart from research and manufacturing, Khorakiwala's customer focused approach helped Wockhardt to look at the healthcare sector. This supported the management to set up super specialty hospitals in different parts of the country in association with Harvard Medical International. "We are amongst the front runner in establishing a comprehensive concept to market program for recombinant biotechnology research. Our team has developed endâ€“to-end capabilities including constructing genes, expressing proteins using three major expression systems. It has resulted in the introduction of two biotech products â€“ Biovac B (Hepatitis-B vaccine) and Wepox (Erythropoietin). We are the leaders in Biovac B in India and we have cornered over 25 percent of the market share for Wepox. We are the early entrants in the global biotechnology market by exporting the above products to South America. This has put India on the global bio-generics map. Exports from the current biotechnology products â€” Biovac B and Wepox â€” and the forthcoming products will be growth drivers in the coming years as the products get registered in numerous countries," Khorakiwala said. Besides India and USA, he said, Wockhardt has identified Europe as a key market for its products. Wockhardt's export market has been growing at a rate of 35-40 percent. In 2002 its international business has jumped to 41 percent. Khorakiwala said, "under new chemical entity program we have also developed a recombinant human insulin and it is undergoing clinical trials. Our new drug discovery program, started four years ago, has yielded lead molecules. And we have completed pre-clinical work of a life saving MRSA responsive anti-infective which is even superior to others. This drug is now undergoing human (phase-I) clinical trials." "A biotech drug has no chemical substitute. Biotechnological products are in a much better position to establish the kind of therapeutics that are required. There is no treatment in those areas. So that time it appeared to me that in 10-15 years it was going to become more and more important. That is what is happening now, " says Habil Khorakiwala, chairman, Wockhardt Ltd. In the field of novel drug delivery technologies, he said, "we are focussing on patentable technology for anti cancer products and other novel drug delivery systems in the areas of cardiology, diabetes and psychotropic substances." Wockhardt launched Progtase Depot Injection--India's first 30-day-acting 'depot' injection and Nadoxin Cream-- India's first and only topical quinolone anti-bacterial, in 2002. Besides doing research in biopharma, Wockhardt is also into agri sciences and aqua business. Khorakiwala divergent views on life sciences pushed Wockhardt to set up agri business venture called Biostadt. "Agri science section is a benchmarking with the leaders in agri industry. We are one of the leading players in the agro-input industry with focus towards diverse business areas like plant growth promoters, plant protection chemicals, seeds and aquaculture products," he said. "Biostadt is amongst the front-runners in establishing the product 'Biozyme' that improves crop productivity. It has found extensive usage and excellent response from the customers on various crops to increase farm productivity. This product is well established in domestic and overseas market. Some of the biozyme-line extensions are biozyme, vegetables and biozyme fruits. Our agrochemical range extends to insecticides, fungicides and herbicides. Biostadt is venturing into the business of marketing seeds under the brand Hi-Q Seeds. As the name itself signifies, we want to keep the highest quality parameter for out product ranges. Hi-Q seeds include F1 vegetable hybrids, cotton and other cereal hybrids," says Khorakiwala. Strong foundation "With 2005 around the corner the larger pharma companies are spearheading the change with greater emphasis towards drug discovery and development and synergies through enhanced reach, economies in scale of operations and in R&D. The opportunity lies in unlocking the potential accumulated in the focussed and continued research and evelopment activities for our biophar- maceuticals, novel drug delivery system products and new chemical entities for tapping both the domestic and international markets. Although we are well positioned in the emerging business, but don't want to lose our market share," Khorakiwala said . Looking at the facts, we have developed a strong team of 300 scientists at the Wockhardt Research Center, which is involved in the pursuit of discovering new drugs, constructing genes, innovating drug delivery systems and novel chiral chemistry for developing active pharmaceutical ingredients, he said Briefing about the R&D initiatives, Khorakiwala said, "our R&D activity is categorized into three divisions. The first division concentrates on developing new bulk drugs (novel drug delivery system) and generics. The second division concentrates on recombinant biotechnology. At present, the second division is focusing on technology absorption with the assistance of scientists from abroad. While the third division is dedicated for discovery of new molecules. Our R&D efforts have resulted in import substitution of various high value bulk drugs as well as formulations. We spent Rs 46 crore on R&D during 2002, compared to Rs 40 crore in 2001. So far we have strategically invested about Rs 200 crore in the past five years." About the future plans, Khorakiwala says, "we are in the process of development of formulations on new molecules belonging to various categories. Research in the field of diseases for which allopathic treatments are not available or side effects are too many." The other side Considering the contributions of Habil Khorakiwala to pharmaceutical industry the government of India is utilizing his services by nominating him to the advisory board, the think tank, of Council Scientific and Industrial Research, for technical inputs on major R&D and other issues of national importance. Like his father Fakhruddin, who is a philanthropist, Habil, a nominated member of the national managing committee of Indian Red Cross Society, too has interests in the community development. In the aftermath of the earthquake that struck Gujarat in 2001, Wockhardt adopted an affected village. He is personally involved with the project and has galvanized the company and employees to help towards the rehabilitation of the village. Khorakiwala, who is married to Nafisa, and has three children, Huzaifa, Murtaza and Zahabiya, loves reading, swimming and management studies. ]]> <![CDATA[Why not Urbani virus?]]> https://biospectrumindia.com/news/95/2469/why-not-urbani-virus.html https://biospectrumindia.com/news/95/2469/why-not-urbani-virus.html Mon, 19 May 2003 18:38:00 +0530 Though it has been afflicting people in China since November 2002, the disease hit the global headline only in March when it infected people in Hong Kong. And for nearly two months, as the scientific world groped in the laboratories to identify the microbe that was believed to cause the disease, it was just called the Severe Acute Respiratory Syndrome or SARS. There are still doubts about whether a new virus of the corona family, which is the real culprit behind the fast spreading global infection. Yet, for want of a better alternative, the world has accepted it as the cause. And it has been simply named the SARS virus. However, there are many health experts who feel that the virus should be named after its most famous victim so farâ€” Dr Carlo Urbani, 46, the deceased director of infectious diseases for the Western Pacific Region of the World Health Organization (WHO). By all accounts he was the first to tell the world about this illness when a mysterious pneumonia hit many nurses in a Vietnam hospital. He alerted the world of the danger of the new disease and died on March 29, exactly a month after treating the first suspected SARS patient himself. Dr Urbani had apparently got the infection from Johnny Chen, an American businessman who entered Vietnam-France Hospital in Hanoi on 26 February with flu-like symptoms. As the senior most public health official in the region he had to make a tricky call about this disease which was mimicking other respiratory conditions, but was not amenable to known treatments. "Carlo's death was the most coherent and eloquent epilogue his life could produce," said Nicoletta Dentico, a friend from the Italian chapter of MÃ©decins Sans FrontiÃ¨res, or Doctors Without Borders, which Dr. Urbani once headed. "His death was as a giver of new life," Nicoletta told The New York Times. And it was in keeping with his medical philosophy. When Dr. Urbani spoke in 1999 at the ceremony in which Doctors Without Borders accepted the Nobel Peace Prize, he described doctors' duty "to stay close to the victims". "It's possible to study an epidemic with a computer or to go to patients and see how it is in them," said Dr. William Claus, the group's emergency coordinator for Asia. "Carlo was in the second category." Before he checked into the Vietnam-France Hospital, Chen had infected at least 80 people, including more than half of the health workers who cared for him. The virulence of his case alarmed world health officials, which led to the extraordinary health alert that WHO issued on March 15. Dr Urbani quickly recognized that the disease was highly contagious and began instituting anti-infection procedures like high-filter masks and double gowning, which are not a routine in impoverished Vietnam. Then he called public health authorities. On 9 March , Dr Urbani and Dr Pascale Brudon, the WHO director in Hanoi, met for four hours with officials at the Vietnam Health Ministry, trying to explain the danger and the need to isolate patients and screen travelers, despite the possible damage to its economy and image. The hospital was quarantined on March 11. Infection-control practices were instituted at other hospitals, including the large Bach Mai state hospital, where Dr Claus of Doctors Without Borders oversaw them. In the middle of it, Dr Savioli said, Dr Urbani had an argument with his wife, Giuliani Chiorrini. She questioned the wisdom of the father of three children of ages 4 to 17 treating such sick patients. Dr Savioli said Dr Urbani replied: "If I can't work in such situations, what am I here for? Answering e-mails, going to cocktail parties and pushing paper?" In an interview with an Italian newspaper, Ms Chiorrini said her husband knew the risks. "He said he had done it other times," she recalled, "that there was no need to be selfish, that we must think of others." Dr Urbani was an expert in Schistosoma mekongi in Vietnam, in the food-borne nematodes and trematodes of Laos and Cambodia and the hookworms of the Maldives. Dr Lorenzo Savioli, who worked with Dr Urbani in the Maldives, told The New York Times that they worked from sunup to sundown, ignoring the famous beaches and reefs, tracking hookworm epidemiology and training workers at a malaria control laboratory, who were used to working with blood, in testing for worms. Over rice and fish in the evenings, Dr. Savioli said, they had joked, " Nobody at headquarters was going to believe we were spending our days in the Maldives over fecal samples." ]]> <![CDATA[Gujarat biotech initiatives]]> https://biospectrumindia.com/news/95/5308/gujarat-biotech-initiatives.html https://biospectrumindia.com/news/95/5308/gujarat-biotech-initiatives.html Mon, 19 May 2003 17:11:00 +0530 Gujarat, a state that witnessed a devastated quake, is now involved in the rehabilitation process. Many organizations are involved in rebuilding the economy of the state. To embank on the speedy growth, the state has been using the biotechnology as a tool of social development. Besides the government wants to create an environment for the growth of biotechnology in the state. Gujarat Chief Minister Narendra Modi has already invited the industry people to make the state a base for their biotech divisions. He also invited the biotech entrepreneurs to invest in Gujarat. Observing that the state was best placed to capture a large part of the growing bioinformatics and contract research markets, he promised that the state government would take all steps to facilitate their investment. Not satisfied with the assurances of the Chief Minister, the industry group has suggested the government to draft a biotechnology policy to leverage the knowledge economy. The industry group said the lack of a clear-cut policy would deter foreign players from investing in the state. The industry says that without a proper framework, operating in Gujarat will be difficult. The state needs policy pronouncements on the lines of Millennium Biotech Policy of Karnataka. The industry feels that the biotech sector should get the concessional sales tax treatment and subsidies as given to other technology intensive fields of IT products and services. The industry is eagerly looking at the opportunities in biotech sector in the state. Arvind Kushwah, research executive, Indus Biotheraputics says, "the state has resources. The state meets over 40 percent of the national need for medicines and is growing at an annual rate of 20 percent much higher than the national and global growth. Even in agri sector, Gujarat is contributing a major chunk to the national economy. It is major edible oil seed producing state in the country. Looking at the opportunity and available resources in the state we see growth for biotechnology. Although biotechnology is still in nascent stage, it will pick up in the state as universities are offering biotech courses. The government is considering setting up Biotech Park. But it will take time as the state is still working on draft biotech policy." Bhavin Palkhiwala, director, Maps (India) Ltd, Ahmedabad, has similar views about the scope of biotechnology in the state. He says, " Biotechnology is a booming sector. Every one is keen to know more about it. Government is making efforts to organize seminars, workshops to create awareness among the general public in Gujarat. Organizations like All India Biotech Association and Ahmedabad Management Association are conducting short term training programs for students and professionals. In July the state government is planning to organize an exhibition on biotechnology to promote the sector in a big way in the state. Definitely the state has better opportunities ahead in biotechnology after missing the Information Technology train." Marching ahead The state has identified thrust areas in biotech and is preparing an effective state biotech policy for its successful implementation. The areas include healthcare and pharmaceuticals, agricultural biotechnology, industrial enzymes, bioinformatics, contract research, marine and environmental biotechnology. The biotech mission will soon start functioning with several incentives and schemes to achieve its well-defined goals. Bridging the network pool The government is also considering promotion of large network of laboratories and related infrastructure and institutions. The government will provide funds for preparation of feasibility studies and detailed project reviews for setting up institutions. The presence of major pharma companies in Gujarat can provide scope for research institutions and universities to take up contract research. The establishment of institutional R&D will push the biotech sector in the state. It can also help in generating and converting biotechnical knowledge into industrial applications and commercial products. The government has announced that it will set up a biotech venture capital fund for promoting biotech units in the state. Apart from promoting establishment of institutional R&D, the government intends to set up an Institute of Bioinformatics to offer academic programs to carry out research and development activities in collaboration with the corporate sector and other related institutions as well as to undertake short term training programs. The government has already earmarked funds for this purpose. The state government has decided to support the individual skilled technical experts and manpower with expertise in biotechnology to take up individual research projects/studies. To promote and develop the biotech sector in the state, the government of Gujarat has made some provisions in the current financial year. The state will help the process of encouraging collaborations with organizations and investment in various biotechnology areas and to provide support through participation of fairs exhibitions etc., through the department of science and technology. Narayan Kulkarni "We are coming out with a clear and friendly biotechnology policy in Gujarat" Gujarat is attempting to make a strong entry into the fast developing biotech industry with a host of initiatives, which include emphasis on developing the human resource base. Narayan Kulkarni of BioSpectrum spoke to Rajesh Kishore, secretary, Department of science & technology, Government of Gujarat, about the state govt. initiatives to promote the biotech sector. Excerpts: What are the biotech opportunities in Gujarat? The state is the home to many big companies like Cadila Pharmaceuticals, Cipla, Zydus Cadila, Sun Pharmaceuticals, Torrent Biotech, Sarabhai -Piramal, Maps India, Gujarat Life Sciences, Gujarat State Fertilizers Cooperation, Sun Agri and Gujarat Narmada Fertilizer Corporation. Most of them have significant biotech activities. Apart from these the state has many small and medium scale industries engaged in different sectors of biotechnology. The state hosts one of the largest agriculture universities in the country, the Gujarat Agriculture University. Gujarat also has a number of institutions involved in biotech research and development such as the MS University, Sardar Patel University, Saurashtra University, Central Salt and Marine Chemicals Research Institute, BV Patel Pharmaceuticals Education and Research Center. These are providing basic and strong scientific back up to the state's biotech initiative. The National Dairy Development Board and the Indian Council for Agriculture Research centers add to the state's institutional resources in biotechnology areas. Which are the areas Gujarat plans to concentrate in biotechnology? The thrust areas include healthcare and pharmaceuticals, agricultural biotechnology, industrial enzymes, bioinformatics, contract rese- arch, marine and environmental biotechnology. In generic pharma, we are the leaders in India by meeting 40 percent of the national needs for medicines. We are now looking at R&D in pharma. Big pharma companies like Cipla, Zydus Cadila, Sun Pharmaceuticals are investing heavily in R&D and biotech research. Hence it is not difficult for us to move from a simple and plain pharma to biotech based pharma state. The pharma companies have a long-term vision. That is why companies like Torrent Biotech, Indus Biotherapeutics and Intas are venturing into the biotech field. The pharma companies have core generic products. They know that the future lies in biotechnology. If you want to be in the market you have to be ready with a new generation of products. The competition is pushing the companies in Gujarat to invest heavily into the biotech sector. Five years down the line they will see big business opportunities in this sector. The companies are also looking at the diagnostic sector as a lucrative one. The next thrust area is the agri sector. The firms in the state are investing in tissue culture, bio fertilizer and bio pesticides. Gujarat State Fertilizers Cooperation, Sun Agri and Gujarat Narmada Fertilizer Corporation and agriculture universities are doing research in bio agriculture. The third major sector is industrial enzymes. The corporates are modernizing, updating and expanding their production and also exporting the same. So the scope for the development of industrial enzyme sector is encouraging. Maps India is doing good work in this sector. Contract research services is the other emerging trend in the state. In addition to these key areas the state is very keen to develop marine biotechnology. We have a 1600 km long coastline with an amazing variety of marine lives. The state is the home of the two Marine National Parks of the country. The Central Salt and Marine Chemicals Research Institute at Bhavnagar has already initiated research and development work in marine biotechnology. We are discussing with the director of the Central Salt and Marine Chemicals Research Institute for setting up a center of excellence in marine biotechnology at the institute. The state government is ready to provide the matching funds for setting up the center. Is the state government preparing a biotech policy that can help industry to grow vertically? Gujarat is a front runner with its industrial promotion policy. We have policies on road, information technology, power, port and industries that opt for special economic zones. Similarly we are c oming out with a biotechnology policy in a couple of months which will focus on developing human resources. It will help the industry to develop in a better way. Lack of educational institutions pulled down our IT initiatives. This time we don't want to make the same errors in the biotech sector. Even though we know it is a long journey, our aim is to first build a strong human resource base in biotechnology. Which will be your focus areas in the state biotech policy? Our focus should be on universities that are offering bioscience courses. The government has decided to develop strong human resource base by funding the universities and other research organizations to set up labs, libraries and train the teachers in biotechnology. We also want to motivate the corporates to go global, even though they don't actually need much support in terms of monetary gains from the government. But we want to support them. A clear biotech policy will give them moral support and help to develop confidence in investing in the state. When the biotech sector is facing the lack of adequate venture capital funding, do you have any plan to provide financial support to start ups? The Chief Minister has already announced the setting up of the biotech venture capital fund with a corpus of Rs 5 crore. Besides, the Gujarat Venture Finance Ltd (GVFL) will pool in an equal amount. With this we will be having a total of Rs 10 crore that will help 8-10 start-up companies. I feel this is a good beginning. If we are successful in the first year, we will seek more funds in the next year. Now the international venture capitalists are also looking at the local partnerships. With this model, I am confident that the industry will be getting good funds from MNCs once we are out with a clear policy. What are the other initiatives taken by the govt. to promote the biotech sector in the state? We are also setting up a biotech mission which will work with the government to promote the biotech sector in the state. It's the key for organizational promotion. The government has also set up a state biotechnology council chaired by the Chief Minister. The council and the different departments of the government are dedicated for this and intend to bring the benefits of biotechnology to the people. ]]> <![CDATA[New contours of convergence]]> https://biospectrumindia.com/news/95/2202/new-contours-of-convergence.html https://biospectrumindia.com/news/95/2202/new-contours-of-convergence.html Mon, 19 May 2003 16:50:00 +0530 Internet and biotechnology are two industries accounting for a big share of the global economy. Additionally, these two industries are responsible for redefining how people live their daily lives. The internet revolution in the commercial, social and civic lives of India and many other countries has accelerated the technological innovation and the entrance of a variety of technologies into an entirely new communications environment. Biotech companies like their internet counterparts, are marvels at venturing into uncharted waters. Innovative gene therapies and other modern techniques are continually advancing the frontiers of medical research and help to treat illnesses that were untreatable in the past. "In contrast to the accelerated growth that the internet has experienced, companies in the biotech sector have just begun to utilize the variety of internet applications available. Although maintaining a web presence and accessibility for research exists for these companies, the industry has relatively overlooked the possibilities of B2B commerce, ASP applications or the ubiquitous wireless domain," says Aditya M Reddy, CEO of Hyderabad -based DeUS Infotech Private Ltd. The company is engaged in the modeling and developing of a net-based bioexchange program that would enable biotech companies to not only interact with each other dynamically but also bridge the digital divide among them. "As of now we have completed the first phase (i.e., the website www.genomevalley.org) of our project and in the second phase comprehensive information on biotech industries and various opportunities in this industry will be made available through the website. In addition, we are also making available all the relevant government policies on this subject. Under the third phase of this project lots of information like job opportunities, list of universities offering biotech research facilities will be made available for the student community as well as for the industry," he added. Biotechnology is like any other industry consisting of small, medium and large corporations. Presence on the net would benefit this industry with increased productivity, better accessibility to company data by researchers, and complementary services for marketing and administration departments. Integrating web and wireless applications for internal systems such as data management, document control, human resources etc., would competitively position a company in this market and the established biotech companies will benefit highly from the innovative internet technologies developed by companies such as DeUS. "We are also in the process of creating a platform wherein foreign companies will find it much easier to decide on their investment plans for India. A contract research organization (CRO) forum is also under consideration where a lot of CRO based companies can come and get projects from foreign companies who are looking for partners in such areas," he explained. Aditya added that the key to future success is to become a decision enabler through the effective and timely exchange of intelligence. DeUS's expertise in internet-based intelligence systems and knowledge of the pharmaceutical and healthcare industry positions its 'genomevalley.org' project as a tool to help companies achieve their goals on the internet. "As of now we are doing this only for the Andra Pradesh government under the genomevalley project but already we are getting a good response from states like Uttranchal and Chattisgarh. Ultimately our aim is to devise an internet based platform wherein all the states will be interconnected and biotech information will flow seamlessly among different states," he explained. Most pharmaceutical, biotechnology, and medical device companies are currently making use of the vast power of the internet merely to display their brochures on their web sites â€” so called 'brochureware'. It will help them to leverage the internet as an essential tool in first exchanging knowledge and, ultimately, in making critical business decisions. It will also help them in attracting the right talent for their organizations, as the platform will also have a window for students to directly come and apply for their desired jobs in the biotech arena. Zia Askari   ]]> <![CDATA[A decent draw at Bangalore Bio]]> https://biospectrumindia.com/news/95/2541/a-decent-draw-at-bangalore-bio.html https://biospectrumindia.com/news/95/2541/a-decent-draw-at-bangalore-bio.html Mon, 19 May 2003 16:50:00 +0530 "Sorry we are here, Wish the world to be disease free" This is what a banner proclaimed at one of the stalls in the trade show and exhibition of Bangalore Bio 2003. This was true to some extent. The organizers had made big effort to get good response by initiating the move and also launching Bangalore Bio 2003. But how was the show overall? The general manager of ClinTec (India) International Pvt. Ltd, which is into clinical trials, Shamiq Hussain said, "it's a good show to participate. We received a couple of enquiries during the first two days. It was encouraging to take part in events like this. These events provide a platform to showcase our company. We can't do any business in just a couple of days." Rajiv Ramanathan, director- business development, Quintiles Spectral (India) Pvt Ltd had similar views. He said, "participation in the events is a part of the business development process. Business can't be done in a couple of days. Events are only the platforms. SR Suresh representing Systat Software Asia Pacific Ltd and participating in the event for the first time said, "The whole idea behind our participation was to have a feel of the industry, to showcase our firm to the industry and to get enquiries. Out of 10, I will rate it at six." The major benefactors of the event were the distributors, who received good number of enquiries. Shiv Kumar, area manager, Jain Biologicals, a distributor, said," this time we got more enquiries compared to the last year." The same is true for other distributors. Platform for future business Korryn Kentopp, director business development, biopharma division, Marken, UK says, "we were here mainly to present our company in India. Actually we don't have customers in India. It is only a platform and potential lead for taking up business. But it was interesting for to receive enquiries during the first two days of the three-day event." "The event has given us lots of ideas and support. We are expected to close the deals with a couple of the companies. The response was tremendous. For us Bangalore Bio 2003 will definitely play a key role in business development," said Sandeep Saxena, business development manager, Scinova India, Pune. Sundaresh Babu, manager-accounts, XCyton Diagnostics, says, " in terms of business potential we have nothing to gain from this event. Yes it had presented us, before the public. From this platform we showcased our company and how our products will benefit the society." Alok Gupta, associate director & head- life sciences & biotechnology, Rabo India Finance Pvt Ltd observed that the event provided the perfect platform for the companies in biotech, healthcare and pharma, instrumentation and infrastructure sectors to showcase the latest in technology, research and trade to a global audience. Apart from regular components of the event, special events helped the industry people to meet and discuss their future plans. Bridging the relation Jayant Nadiger, Trade Commissioner, Flanders, a Federated state of Belgium, had a different view. He said, "Our participation in the event would strength the relationship between Flanders and India that has been developing in the recent past. Dr Villoo Patell, CEO, Avesthagen, has done her postdoctoral work from a university at Ghet in Flanders. Marc Van Montague, a famed biotechnologist from Flanders is a board member of Avesthagen. All these will definitely improve the relations between the two countries. Although the Bangalore Bio was successful in pulling the crowd, Puneet Mehrotra, technical director, Bioinformatics Institute of India, Noida, said, "I think still they have to work a lot. They have to get the IT majors such as Wipro, TCS, Infosys that are into biotechnology/life sciences." Narayan Kulkarni   ]]> <![CDATA[ABLE gives voice to biotech firms]]> https://biospectrumindia.com/news/95/6320/able-gives-voice-to-biotech-firms.html https://biospectrumindia.com/news/95/6320/able-gives-voice-to-biotech-firms.html Mon, 19 May 2003 16:50:00 +0530 Around 160 biotechnology companies with a combined revenue of over $150 million encompassing diverse domains of biotechnology covering industrial enzymes, plant biotechnology and diagnostics to bio-therapeutics, have come together to create a new platform, to highlight the sector's interests. The companies are offering a plethora of products and services based on agri-biotech, bioinstrumentation, bioengineering and bioinformatics. The executive board of ABLE headed by Kiran Mazumdar Shaw, chairperson and managing director, Biocon India as president, comprises of Varaprasad Reddy, managing director, Shantha Biotechnics as the vice president, Vijay Chandru, chairman, Strand Genomics as the general secretary and Villoo Morawala Patell, CEO, Avesthagen as the treasurer. The association has set up support teams across the country for the member ship drive. According to Kiran Mazumdar Shaw, president of ABLE, it will play the same role for the biotech industry as Nasscom does for the IT sector. "It will become the collective face of the biotech industry," Shaw said. The main objective of ABLE is to accelerate the pace of biotechnology in the country by enabling strategic alliances between the researchers, governments and the global biotech industry. It will showcase breakthrough technologies and cutting edge biotech initiatives that will take the Indian biotech sector new frontiers and promote biotechnology in both the industry and academia, and forge a stronger link between research and the commercialization of emerging technologies. ABLE will seek to equip an entrepreneur, a scientist, a student, a government, an industry or an investor with inputs in any sphere of Biotechnology that he/she requires. From guiding emerging technological breakthroughs to presenting job opportunities and enhancing the potential of commercializing biotech research, ABLE will represent the interests of all stakeholders of biotechnology in India. In addition, it will act as a single point of reference for exclusive and comprehensive information relevant to the Indian Biotech industry. It would generate access to policies of the Indian government towards biotechnology, including transitory changes in the regulatory and patenting framework. Narayan Kulkarni ]]> <![CDATA[India's Dr Diagnostics]]> https://biospectrumindia.com/news/95/2003/indias-dr-diagnostics.html https://biospectrumindia.com/news/95/2003/indias-dr-diagnostics.html Mon, 19 May 2003 16:46:00 +0530 When AIDS (acquired immuno deficiency syndrome) hit the Indian shores in a "I found this situation unique. And also challenging. I spotted an opportunity here and wanted to make use of it. It was a challenging task for me as it was a politically sensitive issue too. With the support and encouragement from the experts and academicians I over came all the hurdles to develop an indigenous product to detect the HIV virus accurately," said Dr BV Ravi Kumar, chairman and managing director, XCyton Diagnostics Ltd, Bangalore. The same product got the first Best Bio Product Award presented by Rabo India at Bangalore Bio 2003 in mid-April. "I was really thrilled and encouraged when I got the Rabo India Bio Business Award for my product. The award will help me to do more things differently and achieve some thing in life," he added. Expecting to repeat the achievements many times over, Dr Ravi Kumar recalled the Conqueror King Napolean's word: " Give me more medals. I will win more wars". Father's influence on young child "When I was in the first year of schooling, my father, Narasimha Rao, a lawyer, used to say that a country like India required lots of the medical field and take up new drug discovery efforts in a big way. A great admirer of Mahatma Gandhi, he always used to say that doctors should not look at the wounds but think about preparing the ointment which cures the ailment," recollected Dr Ravi Kumar. My father also felt that such an approach would serve not just the injured patient but would help millions of people in the same category. He believed in the potential of the marginalized people, and emphasized that they could contribute a lot to the country. This was the message ingrained in me since childhood, observed the award winner. There were other strong influences too on Dr Ravi Kumar who grew up in a family which placed a lot of emphasis on patriotism. His father had provided many legal services to a large number of poor fishermen of Andhra Pradesh free of cost. Dr Ravi Kumar's father had apparently helped many fishermen to win cases against big fishing companies creating problems for the local fishermen. " I really didn't know at that time why he had wanted me to take up a career in medicine but he influenced me a lot. His vision about the country had pushed me to embrace medicine and medical research in particular", said Dr Ravi Kumar. After completing his MBBS from the Jawaharlal Nehru Institute of Post-graduate Medical Education and Research (JIPMER), Pondichery, he worked with a cardiologist and professor Dr GD Gupta for a short period. It was Dr Gupta who pushed him to take up medical practice. But when Dr Gupta left JIPMER, he too left the profession to continue his master's in medicine. Later he joined the Indian Institute of Science (IISc), Bangalore, to pursue postdoctoral research. After completing a PhD degree at IISc, where he received Prof. Giri memorial gold medal for the best thesis, he got an offer to work at the Astra Research Center India (ARCI). During his 8-year stint at ARCI he got good exposure to diagnostic kits. He developed two kits, one to detect the tapeworm and the other for tuberculosis diseases. He learnt the art of developing the kits at Astra and also acquired the skills of developing the same. "It's totally a different experience for me, " recollected Ravi Kumar. Venturing into diagnostics with XCyton During the mid-1990's the country used to import diagnostics kits to conduct HIV tests. The public awareness about the HIV tests was not very encouraging during that time. Yet the medical community was clear that this area required a lot of attention but they recognized this as a major gap in India's heath care systems. India used to import about 2-2.5 million kits in 1996. No company was eager to come out with diagnostic kit to conduct HIV tests. Apparently, companies were unsure of the market size. There was also a lot of stigma and fear attached to the HIV tests. "My exposure and experience at ACRI helped me to take up this task. The challenge before me was to develop a kit of high quality that will bring in confidence among the medical community and also among the public" Dr Ravi Kumar observed. With the support and encouragement of experts and academics like Dr V Ravi, Prof. P Balram, Prof. Chandramukhi, Prof.G Padmanabhan, the recipient of the first distinguished biotechnologist award from the Department of Biotechnology, Dr Ravi Kumar ventured into the manufacturing of diagnostic kits for HIV by starting XCyton Diagnostics Ltd, in December 1993, with an initial capital of just Rs 7 lakh. Passing through hurdles Narrating his experiences in developing the company, he said, "the initial days were very tough for us. I had a very bad experience from a venture capital funding agency. In September 1994, a venture capitalist firm went back after completing all negotiations and finalizing the legal documents. That was the first set back. Without losing the faith in our technology we took it as a challenge to continue in our project. I had already left Astra at that time and it was a nightmarish experience." But friends from the research community came to his rescue. They had full faith in the technology under development at XCyton. They encouraged him to go ahead and complete the project. Despite not having much surplus funds, they helped the young company to continue with the business. Prof. AK Rao supported the company by contributing Rs 2.5 lakh out of his retirement fund of Rs 6 lakh. Prof. Gopal Krishna also helped the firm. Although they were not the professional entrepreneurs, their support helped the company to continue with the diagnostic kit development. With this seed money Dr Ravi Kumar and his team completed the product and took it to the Drug Controller General of India (DCGI) for approval tests. In 1995, he managed to get some funds from the Small Industries Development Bank of India (SIDBI) to set up a laboratory, the first of kind in the country. In 1996 the company got the license to develop the kit for commercialization purpose. Later the firm also received funds from Canara bank. The Technology Development Board (TDB) also chipped in with some funds to help the struggling company. Contributions in medical diagnostics Dr Ravi Kumar made a significant contribution to biotechnology, particularly in the field of medicinal diagnostics, by conducting the necessary basic research in a goal-oriented fashion to develop a diagnostic kit. These were the kits for neurocysticercosis and HIV. In 1993, the National Aids Control Organization (NACO) compiled data from across the country and confirmed that more than 95 percent of HIV infections in India were due to HIV 1C and by 1997, HIV-Chex with peptides of HIV 1C was introduced into the market. The HIV-Chex kit was developed in association with the IISc and NIMHANS, Bangalore. XCyton also developed a product called HEP-Chex C from the results of the research conducted at International Center for Genetic Engineering and Biotechnology and All India Institute of Medical Science (AIIMS), New Delhi. This Elisa kit was launched to detect Hepatitis C. Then XCyton got the license from AIIMS for using the technology for commercialization. AIIMS has already used this test kit to screen over 1.5 lakh samples at its institute with satisfactory results, Dr Ravi Kumar said. The kit specifically incorporates the antigen of HCV subtype 3g, which accounts for 35 percent of the cases in India. When asked about any memorable event Dr Ravi Kumar said, "I felt satisfied when I used to receive evaluation reports saying that the kit is good. I was amazed when I got the customers' reports saying that they have detected the cases using our HIV-Chex kit." Areas of interest Leading a happy family with a son, who is pursuing medical education, and a daughter, studying in the 10th class, Dr Ravi Kumar loves to do mimicry, miming, quiz and reading books on marketing. He had won many prizes during his college days by participating in many cultural events. "I even love to act but it is the time that is not permitting me to do so," he quipped. Narayan Kulkarni "India is a potential market for diagnostic kits" Dr BV Ravi Kumar, chairman and managing director, XCyton Diagnostics Ltd explained his company's position and also about the future plans in an interview with BioSpectrum's Narayan Kulkarni What is the present financial status of your company? The XCyton was started with a seed capital of Rs 7 lakh. And later we got a core fund of Rs 50 lakh from private investors. Now we have 20 people. We have grown from Rs 7 lakh to a Rs 2.2 -crore company in the last five years. I must say I am lucky enough to get good people. As a start up company which is making losses, it is very difficult to get highly talented people. But in my case I have got a lot of talented people. We have crossed the break-even point this year by making a small operating profit over last year's heavy losses. We are supplying kits to conduct about four million tests in the country. We are in the process of acquiring another company. Once the process is over we will double our supply. What is your marketing strategy? We have established our marketing and distribution network in the last five years in south India and Maharashtra. Now we have signed an exclusive marketing arrangement with Qualigens Diagnostics, the chemical division of GlaxoSmithKline Pharmaceuticals Ltd, to expand our market and to get an exposure across the country. Qualigens Diagnostics will market HIV and hepatitis-C kits under the brand name HIV- CheX and HEP-CheX C in the country. What is your future plans? With a strong foothold in Elisa kits we are now moving towards the development of rapid tests and polymerase chain reaction (PCR) kits. There is immense potential for PCR kits in the near future. At present we are developing DNA based PCR kits for Bacterial Meningitis in children with technology from Astra Zeneca. We will also be developing rapid kits for neurocysticercosis, which is at present available in the form of Elisa. Rapid tests for HIV, HCV and PCR for TB will soon be added to our product portfolio. We are also developing an Elisa kit that can detect cases of Pulmonary Tuberculosis, which are sputum smear negative for acid fast bacilli but show the growth of bacilli when sputum is subjected to culture of Mycobacterium Tuberculosis. This kit will be a useful substitute to X-ray examination of chest in the private practice. This kit uses multiple but highly purified antigens of mycobacteria. It also takes in to consideration those antigens that circulate as immune complexes. This kit is being developed in collaboration with the Tuberculosis Research Center, Chennai. XCyton is also in the process of developing an Elisa kit for the detection of Tuberculosis Meningitis. This kit takes into consideration the differences in immunological responses observed between serum and central nervous system due to synthesis of immunoglobulins in side the blood brain barrier. What are your R&D initiatives? The R&D of diagnostics, though faces technology barriers, is not as expensive as drug development. A drug development is a huge program but this is not the case with diagnostics. We are going to create novel immuno- diagnostics for diseases like TB Meningitis. The R&D facilities are strong in terms of strong collaborations and in each sector with best expertise in the country. We have invested more than what we can afford to spend on our R&D program. Even during the crucial timings we spent a lot. The substantial amounts spent on technology has helped us to cross the break-even mark this year. We are planning to invest Rs 1.5 crore for the next one-year for technology and products development. We want to grow bigger in the next one and a half years. ]]> <![CDATA[The Tulsi spread]]> https://biospectrumindia.com/news/95/2272/the-tulsi-spread.html https://biospectrumindia.com/news/95/2272/the-tulsi-spread.html Mon, 19 May 2003 16:34:00 +0530 "We were in the US doing our studies and while contemplating the future, we just did a check on genomics companies on Infoseek in 1996-97. Three names came up including Craig Venter's The Institute for Genomics Research. Then we thought why not do something that will help these companies," recollects Ocimum's CEO, Anuradha Acharya. " Then we discussed with my aunt, Dr P Sujatha, a rice genome researcher from the A & M University, Texas. With her help we met some people at the well known company Rice Tec and offered to develop a few software tools to make the sequencing work simple," added her husband and Ocimum's director, Subash Lingareddy. So the duo developed a web-based prototype for genome sequencing. "We came back to India and were wondering what to do. So we started Ocimum Biosolutions as a limited liability company (LLC) based in the US in August 2000 to take up plant genome sequencing work with an investment of $500,000 with his aunt", Anuradha said. " We put in $150,000." Ocimum is the botanical name of the Tulsi plant. They set out to identify gene sequences in various plants on contract for various companies for patenting them. However, a US court ruling which disallowed patenting of just sequences without knowledge about their specific utility put an end to all such work by various companies. " We reworked our business model and it took six to nine months to change it to become a contract research service provider," Subash said. In February 2001, Ocimum Biosolutions was set up in Hyderabad, where the couple resides, With four or five people, Ocimum's goal was to become a 'wet lab' which will do the sequencing work and also the analysis. They complement each other well in running the company. Anuradha is a computer expert and Subash specializes in finance. Subash's family runs the well-known Hyderabad-based pharma major, the $50 million Saraca Group. Saraca is the world's largest producer of Sulpha methaoxazole. The group is also among the top three producer of Ranitidine. The India operation started as a research center for the US company and has since become a profit center too. The software tools became branded products â€“ Biotracker and Gencheck. The employees had to be trained in various bioinformatics tools and so the training activity got a formal structure. A 20-week certificate course is offered in collaboration with the Michigan Technological University. Over a 100 people have been trained in a structured six-month program, with 25 to 30 people in a batch. The curriculum was designed to cater to Ocimum's needs and the students start working with the company's various project, in about three weeks. Ocimum's software tools and microarray analysis techniques have found many takers. Recently, the company has got an order to set up a four-person lab to do analysis work at the Mount Sinai Hospital for Joint Diseases in Washington DC.A five year grant has been given to Ocimum for this work. Many researchers now work with software tools that help to visualize the gene sequences. Ocimum has developed the interface to work with such tools for a Singapore company. The company has worked out detailed plans for growth. " In the short term, we are concentrating on product sales, customize them and develop niche products in the medium term. Our long-term goal is to enter the drug target discovery tools and validate them. We plan to build a lot of intellectual property rights in these areas," Anuradha said. Ocimum is currently implementing the ISO 9001 standards across the organization. Most the investments have come of internal accruals. The company has set a target of break- even in operations by 2003-end. It's turnover is estimated at $200,000. The company is now a full-fledged contract research and development organization with competencies in bioinformatics, genomics, proteo- mics and custom contract research services. Besides Genchek and Biotracker, it has products like Microtracker, Nutrabase, Pathtracker, Genowiz and Proteowiz. "Indian companies have great opportunities in this sector. But we have to demonstrate our capabilities and not rely just on price. We have to build the building blocks of competency," Anuradha advised other startups in the field. N Suresh ]]> <![CDATA[Bangalore Bio 2003 Album]]> https://biospectrumindia.com/news/95/3018/bangalore-bio-2003-album.html https://biospectrumindia.com/news/95/3018/bangalore-bio-2003-album.html Mon, 19 May 2003 16:25:00 +0530 Karanataka Chief Minister SM Krishna inaugurating the Bangalore Bio 2003 by lighting the traditional lamp Chief Minister SM Krishna releasing 'Bio-education in Karnataka', an analysis brought out by the Vision Group on Biotechnology The Association of Biotechnology Led Enterpries (ABLE) team led by its president Kiran Mazumdar Shaw at the organization's launch with KL Chugh of ASSOCHAM (fourth from right) Kiran Mazumdar Shaw, during the inauguration ceremony of - Association of Biotechnology Led Enterprises (ABLE) Dr Villoo Morawala-Patell, CEO, Avesthagen presenting a paper on IPR & PR at the session Vivek Kulkarni, Secretary ,BT & IT, Govt of Karnataka speaking at the inaugural session of the conference Kiran Mazumdar Shaw sharing a lighter moment with Dr Samir Brahmachari, Institute of Genomics and Integrative Biology, New Delhi DB Inamdar, Minister for IT & BT , Govt of Karnataka, at the inaugural ceremony of Bangalore Bio 2003 Audience at the round table session - 'venture capital funding' Some diversion to the serious business activities Eager readers at the Biospectrum stall ]]> <![CDATA[We need new funding sources for innovations]]> https://biospectrumindia.com/news/95/1491/we-need-new-funding-sources-for-innovations.html https://biospectrumindia.com/news/95/1491/we-need-new-funding-sources-for-innovations.html Mon, 19 May 2003 16:18:00 +0530 The government has been the major financier of science and technology (S&T) based innovations in India, with around three fourths of the research and development (R&D) expenditure coming from government funding. However, as India awakens the scientist in an entrepreneur and entrepreneur in a scientist, we will require significant funding sources for taking Indian innovations to the market place. Take, for instance, the drugs and pharmaceuticals industry. In the old patent regime, where we did not accept product patents, Indian industry could build itself by copying the molecules developed in the west, sometimes with innovative processes and sometimes with not so innovative processes. But with the product patents being accepted from 1st January 2005, Indian industry will lose this luxury of copying and it will have to get into the game of discovery of new molecules. In the current context, taking a single molecule to market place required 10 to 12 years and about $500 million dollars; which is approximately the size of our entire space research program. Therefore, new sources of funding will have to be sought. Let us focus on venture capital. In the west, it is specifically defined as equity linked investments in young privately held companies, where the investor is a financial intermediary, who is typically active in the firm. The venture capitalists provide equity investments in companies that are not mature enough to get access to capital market but have high growth potential to compensate for the concentrations inherent in such ventures. It is the availability of such a venture capital that has led to the spectacular growth of technology driven enterprises around the world. Indeed, Apple in computers or Genentech biomedical products would not have seen the light of the day, but for the availability of such venture capital. There are both tangibles and intangibles in venture funding. One of the crucial sources of value provided by venture investors is their ability to certify companies to other investors. For instance, venture-backed firms are much more likely to attract the interest of a reputable investment banker and complete an initial public offering. Similarly, corporate business development groups are much more likely to invest in new firms backed by venture investors. Thus, the financing contributed by the venture investor is often relatively modest compared to the total amount that the venture-backed firm finally raises. United States has been a pioneer in venture capital. The formal venture capital industry in the US dates back to the formation of the first fund, American Research and Development, in 1946. However, the flow of money into new venture funds for the next three decades never exceeded a few hundred million dollars annually. A dramatic change came with the 1979 amendment to the 'prudent man' rule governing pension fund investments. Prior to 1979, the Employee Retirement Income Security Act (ERISA) limited pension funds from investing substantial amounts of money into venture capital or other high-risk asset classes. The Department of Labor's clarification of the rule explicitly allowed pension managers to invest in high-risk assets, including venture capital. In 1978, when $424 million was invested in new venture capital funds, individuals accounted for the largest share (32 percent). Pension funds supplied just 15 percent. Eight years later, when more than $4 billion was invested, pension funds accounted for more than half of all contributions, and this proportion has been growing over the years. We know the way the venture capital has spurred innovation in the US, but great results have been shown elsewhere also. For example, the Israel government initiated two programs to encourage the formation of venture capital funds in 1991, these increased from $29 million to over $550 million in 1997 due to a burst of investment by foreign high technology companies in Israeli R&D. We need a serious relook at the Indian situation and provide major incentives for venture financing. How do we build innovative firms, institutions and organizations? For this we will have to set up truly innovative and proactive mechanisms, that will drive innovation. There is so much to learn from the innovative firms around the world. Some firms set up goals that stretch your mind. For example, Du Pont has defined a set of 'unreachable goals' like immortal polymers, zero waste processes, elastic coatings as hard as diamonds, elastomers as strong as steel, materials that repair themselves, chemical plants that are run by a single chip and coatings that change color on demand. These may sound unrealistic but they are publicized widely and enthusiastically supported. Intel motivates its innovations by saying "Double machine performance at every price point every year". Risk taking must become a part of the innovation policy of firms. Innovative institutions have no place for those who preserve the systems in a pre-fabricated and unaltered way. A friend of mine, who is a CEO of a company from abroad, once said 'we do not shoot people, who make mistakes. We shoot people who do not take risks. What do you do?' I said, 'In India, we shoot people, who take risks!' We need a change of mind set. Just as scientists and technologists are risk averse so are in the institutional systems. One must seriously look at the scope of innovation in government institutions and laboratories, which are risk averse. In fact, it is more often than not that such institutions are run by rules and regulations than by objectives. The system of S&T audit in our laboratories needs an urgent relook. One must understand that manufacturing and S&T are two different endeavors, culturally and operationally. In manufacturing, we look for zero defects and no failures, whereas in science, there is a fundamental right to fail. An interesting analysis has been done by Stephen and Burley in 1997 for Industrial Research Institute, which lists out the significant odds facing would be innovators by analyzing consistent data from new product development, potential activity and venture capital experience. It has been shown that there is a universal curve, which illustrates the number of substantial new product ideas surviving between each stage of the new product development process. It has been shown that out of 3000 raw ideas (hand written), 300 are submitted, which lead to around 125 small projects, further leading to nine significant developments, four major developments, 1.7 launches and one success. Continuous assessment by shedding projects along the innovation chain is a rule rather than exception. In India, it is the other way around, since if they are abandoned at an intermediate pilot stage, there is a risk of the dreaded audit para! I believe we need to create a new set of leaders who are visionaries and thinkers, who believe in discontinuities, who are capable of thinking of the impossible and inspiring people to make it happen. After all, there is a definition of an innovator. They say innovator is one who sees what everyone else sees but thinks of what no one else thinks. Innovator is also one, who does not know that it cannot be done. An innovative leader sets stretched targets. I have emphasised so far on S&T based innovations but the concept of innovation is a much wider one. It is particularly important to recognize the need of social innovation. Innovation in India's social and economic institutions, in the system of their governance is as crucial as innovation in the products and production processes of its economy. We must also recognize that innovation cannot arise by itself; it is generated and sustained through the efforts of its people. The government needs to create an environment, in which innovation flourishes. Otherwise the innovators will either play safe and not innovate, or they will leave to become a part of other innovative societies, which encourage innovation, as India has seen to its dismay; since a lot of its young sons and daughters have left, not due to the lure of the physical income alone, but because of the psychic income that they gain in those innovative societies. We must reverse this process with speed and urgency. RA Mashelkar ]]> <![CDATA[News Bites]]> https://biospectrumindia.com/news/95/1455/news-bites.html https://biospectrumindia.com/news/95/1455/news-bites.html Fri, 16 May 2003 18:18:00 +0530 NCL gets fund for DNA chip project The Pune based National Chemical Laboratory (NCL), a constituent lab of the CSIR, has received funds from the Department of Science and Technology for it's three year project to develop DNA chip as a cheaper alternative to DNA sequencing. According to reports the project will help to identify specific genetic disorders like Thalessemia. The reports say that if this works, scientists can target India-specific genetic disorders like hypertension. Foundation laid for Bangalore Helix Karnataka chief minister SM Krishna laid the foundation stone for the biotech park, "Bangalore Helix". The CM said the government is investing Rs 150 crore in the project on 150 acres of land near Electronics City Phase III on the Bangalore-Hosur Road. This is to be developed in two phases over the next 18 months. In the first phase 75 acres would be developed. The park, which is meant to give the state its biotech edge, will house small and big biotech companies, research bodies and start-ups. 100 acres marine BT Park in Tamil Nadu The government of Tamil Nadu has earmarked 100 acres to set up the marine biotechnology park, proposed to come up along the East Coast Road about three kilometers ahead of Mahabalipuram. According to reports, the park, to be established at an investment of Rs 50 crore, is envisaged as an incubator facility to address investment initiatives in this sector. It will provide an opportunity to harness marine, micro and macro organisms through innovative technologies and systems for comm- ercial application in areas such as nutrition, pharmaceuticals, industry and recreation. Biogenus project to provide 1000 jobs The Biogenus project at Karwar will provide job opportunities for 1000 skilled laborers from the coastal belt of Karnataka. The Biogenus India has recently singed a memorandum of understanding with government of Karnataka for setting up marine biotechnology research center and aqua culture and has made investments to the tune of $20 million for the same. According to reports, the CEO of Biogenus, Lukose Vallartharaj, has already visited Kumta, where the park is about to come up. Avesthagen joint venture with BioMerieux Avestha Gengraine, a bangalore based company has signed a MoU with the French company BioMerieux to do R&D in the field of Molecular Diagnostics. Talking at the French Indian Business Meeting held during Bangalore Bio 2003, Villoo Morawala-Patell, founder and CEO of Avesthagen said now they are focussing in the field of research based on human therapeutics and diagnostic kits for diseases like diabetes and tuberculosis. "We are looking for global partnership for co-development and out-licensing of intellectual property in each of these areas," she added. Avesthagen has had tie-ups with the Indian companies like Advanta India, Astra Zeneca, etc. Karnataka clears projects The high-level committee of the government of Karnataka, headed by chief minister SM Krishna has cleared 12 project proposals worth Rs 3,620 crore and having an employment potential of about 69,000. The projects include setting up of R&D facility for ayurvedic medicine and formulations at Bidadi by Himalaya Drug Company at an investment of Rs 165-crore. Astrazeneca India Pvt. Ltd has also received the approval for its proposal of setting up a Rs 72.57-crore R&D center for development of anti-TB drugs and other drugs and formulations at Hebbal. ]]> <![CDATA["India has bright future for conducting clinical trails"]]> https://biospectrumindia.com/news/95/2250/india-has-bright-future-for-conducting-clinical-trails.html https://biospectrumindia.com/news/95/2250/india-has-bright-future-for-conducting-clinical-trails.html Fri, 16 May 2003 18:16:00 +0530 "India has to adopt the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) guidelines for good clinical practice to establish and to compete in the international market," said John Kolthammer, CEO, The Institute of Clinical Research (ICR), UK. Delivering a lecture on the "Good Clinical Practices, the new imperatives" organized by ClinTec International at Bangalore, he said the ICH harmonized tripartite guidelines were developed with consideration of the current good clinical practices of the European Union, Japan and the USA as well as those of Australia, Canada the Nordic countries and the World Health Organization. He maintained that although India is not a signatory for this guideline, it will benefit from following the ICH harmonized tripartite guidelines to enter into the global market. He observed that the future for conducting clinical trials in India is bright. Explaining about the essentials of having Good Clinical Practices (GCP), Kolthammer said GCP is an international ethical and scientific quality standard for designing, conducting, recording and reporting trails that involve the participation of human subjects. Kolthammer said, the objective of the ICH-GCP is to provide a unified standard for the EU, Japan and the USA to facilitate the mutual acceptance to clinical data by the regulatory authorities in these countries. Since 1997, ICH GCP has been the acceptable way of conducting pharmaceutical clinical research, he said. At present 5000 skilled people are working for ICR. ]]> <![CDATA[Wipro ties up with Avesthagen]]> https://biospectrumindia.com/news/95/1546/wipro-ties-up-with-avesthagen.html https://biospectrumindia.com/news/95/1546/wipro-ties-up-with-avesthagen.html Fri, 16 May 2003 18:14:00 +0530 Wipro seems to be focussed on ramping up its competence in biotechnology. It has recently entered into an alliance with the biotech company Avestha Gengraine (Avesthagen) to exploit the convergence between information technology and biotechnology. The two companies have an open-ended agreement to work on projects that require competence in both their areas. The two companies are equal partners bringing in their domain expertise in the areas of biotechnology and information technology respectively. Avesthagen's research focuses on agricultural biotech and has an expertise in population genomics which could be leveraged by Wipro's newly-formed Wipro Healthcare and Life Science, which needs the biology related expertise. The biotech firm is also involved in bioinformatics, which is basically an inhouse support system for gene discovery, annotation of genes and software development. Sources said that the two organisations expect their synergies to help establish their presence as leading players in the IT-BT convergence area. Together they will be targetting companies in the west that are looking to outsource projects in this area to Indian companies. IT companies venturing into the biotech arena are increasingly forging alliances with other organizations for this reason. Tata Consultancy Services has a partnership with the Centre for DNA Fingerprinting Diagnostics at Hyderabad and Bangalore based Strand Genomics has a partnership with Syngene. Wipro recently created a new business to look at the healthcare and bio-IT sector in a big way. In biotechnology, the company plans to focus on developing bio-informatics solutions for life science companies to reduce the drug discovery cycle time and also to offer solutions to medical and analytical device companies.   ]]> <![CDATA[GEAC rejects Bt Mech 915]]> https://biospectrumindia.com/news/95/2568/geac-rejects-bt-mech-915.html https://biospectrumindia.com/news/95/2568/geac-rejects-bt-mech-915.html Fri, 16 May 2003 18:12:00 +0530 The Genetic Engineering Approval Committee (GEAC) at its meeting on April 25, rejected Mahyco-Monsanto Biotech (MMB)'s application for commercial cultivation of Bt Mech 915 variety of Bt cottonseed in northern India. According to GEAC chairperson Sushama Choudhary the Bt Mech 915 hybrid cottonseed developed by MMB is sensitive to dangerous leaf curl virus. This has pulled the GEAC to go against the MMB's proposal. The Central Institute for Cotton Research (CICR) that conducted detailed evaluations of field trials in nine locations in north India has pointed out this aspect as one of the shortcomings of Mech 915-hybrid cottonseed. The CICR report also analyzing the fibre samples of Bt cotton reported that it was not up to the mark. ]]> <![CDATA[Bioinformatics, the emerging technology for developing new drugs]]> https://biospectrumindia.com/news/95/2247/bioinformatics-the-emerging-technology-for-developing-new-drugs.html https://biospectrumindia.com/news/95/2247/bioinformatics-the-emerging-technology-for-developing-new-drugs.html Fri, 16 May 2003 18:06:00 +0530 The increasing pressure on life science companies to generate more drugs in less time is creating remarkable interest in bioinformaticsâ€”the storage, organization and analysis of biological data. Bioinformatics is also referred to as a marriage of computer science and molecular biology. In keeping with the importance of Bioinformatics in the coming days and months, InBios, a non-profitable organization conducted 'Brainstorm 2003', a platform for students and the industry to interact with each other at Hyderabad. The event saw a number of participants from different biotech players within the region including Hyderabad based Ocimum Biosolutions and Ingenovis. "The major factors driving the growth of bioinformatics include the pharmaceutical industry's need for more efficient drug discovery and development, coupled with an emphasis on the rapid generation of sequence data," said Ashwin Padmanabhan, product specialist at Hyderabad based Ingenovis - a division of I-labs. Other reasons for the expansion of the technology include the emergence of gene expression data, the generation of new proteomics data and the need for information systems those store and process large amounts of biological data. Bioinformatic analysis basically involves the use of computer algorithms to compare newly sequenced genes with databases containing genetic sequences that have known functions. Since the advent of bioinformatics, large public and private databases have been formed that contain a variety of data, including gene and protein sequences, and even the 3-D structure of proteins and cellular components. Currently, most bioinformatics data are genetic sequence data. Private enterprises and public efforts have created DNA sequence databases that can be used to infer the functions of an unknown gene. The analysis of proteins through automated data collection, database formation and data analysis using computers (proteomics) is not yet as established as genomics research because proteins are more complex than DNA. However, proteomics research is expected to flourish because proteins do the actual work for genesâ€”whether that work results in maintaining health or causing disease. "The technology is versatile and can be applied whenever gene, protein and cell research are used for the discovery of a new drug or a new herbicide/herbicide-resistant crop combination. Drug toxicology, pharmacogenetics and clinical trial studies can also benefit from this technology, which can even be used to genetically engineer crops and livestock that have enhanced nutritional qualities and the ability to produce harmaceuticals," said Anuradha Acharya, CEO, Ocimum Biosolutions. One thought which came out of the event was that by offering higher productivity in drug discovery and development, bioinformatics can also enable companies to obtain patents earlier, reducing the loss of revenue caused by generic competition once patents expire. The InBios event was well attended by a large group of students from Pulla Reddy college of Pharmacy. In the future, InBios plans to provide professional solutions and services dedicated to improve efficiency, competitiveness, and profitability to aspiring people who want to make a career in bioinformatics. ]]> <![CDATA[Scientists develop new method for producing transgenic eggplant]]> https://biospectrumindia.com/news/95/1792/scientists-develop-new-method-for-producing-transgenic-eggplant.html https://biospectrumindia.com/news/95/1792/scientists-develop-new-method-for-producing-transgenic-eggplant.html Fri, 16 May 2003 17:42:00 +0530 Scientists have developed an efficient variety â€“independent method for producing transgenic eggplant (Solanum melongena) via Agrobacterium tumefaciens -mediated genetic transformation. Prof. G Lakshmi Sita, and Prof. G Franklin, Department of Microbiology and Cell Biology, Indian Institute of Science, have demonstrated for the first time that an efficient genotype â€“independent A. tumefaciens â€“mediated transformation of eggplant using root explants. Using this standardized protocol, root explants can be routinely utilized for the transformation of eggplant with various genes because of its high susceptibility towards A. tumefaciens and quick regeneration capacity on selection media. The root explants were transformed by co-cultivation with A. tumefaciens strain LBA4404 harboring a binary vector pBAL2 carrying the reporter gene beta - glucuronidase, intron (GUS-INT) and the maker gene neomycin phosphotransferase (NPTII). Transgenic plants were raised in pots and seeds. Histochemical GUS assay and polymerase chain reaction analysis of field established transgenic plants and their offsprings confirmed the present of the GUS and NPTII genes, respectively. Integration of T-DNA into the genome of putative transgenics was further confirmed by the southern blot analysis. Progeny analysis of these plants showed a pattern of classical Mendelian inheritance for both the NPTII and GUS genes. Eggplant is an important vegetable crop widely cultivated in countries such as Spain, France, Italy, Greece, North Africa, India, and China. In India, the eggplant fruit forms an integral part of the diet for the majority of the vegetarian population. The annual production of this vegetable is severely limited by several soil-borne pathogenic viruses and major pests belonging to the order Lepidoptera (fruit borer). Sources resistance against Fusarium wilt and mites exist in the closely related spices Solanum integrifolium, which has been reported to be a possible source of pest and disease resistance for the improvement of eggplant. However, owing to deleterious gene linkages, the incorporation of these traits into the eggplant gene pool by breeding has been slow and inadequate. Despite this, improvement through hybridizing somatic cells of sexually incompatible Solanum species has been employed as a potential method for introducing disease resistance traits. Prof. Lakshmi Sita maintained that A. tumefaciens mediated transformation is an effective and widely used approach to introduce desirable genes into plants. In this research Guri and Sink were the first to report Agrobacterium â€“mediated transformation of eggplant, quickly followed by others. All of the transformation protocols reported by these investigators use hypocotyl, cotyledon or leaf segments as explants with low â€“frequency transformation. ]]> <![CDATA[IBM announces free Web services to track DNA]]> https://biospectrumindia.com/news/95/1657/ibm-announces-free-web-services-to-track-dna.html https://biospectrumindia.com/news/95/1657/ibm-announces-free-web-services-to-track-dna.html Fri, 16 May 2003 17:34:00 +0530 IBM is giving away free Web services technology to help scientists track down DNA, as the company continues its push into the promising life sciences arena. Big Blue has also announced that it along with partner Proteome System has landed a multi-million dollar deal to provide Charles River Laboratories International with technology related to proteomics, which is the study of protein structure and function. In its Web services offer, IBM said it was making available free trial software designed to improve searches for information stored by the National Center for Biotechnology Information. The center hosts public databases PubMed, which contains biomedical journal citations, and GenBank, which contains genetic sequences. According to IBM, searching for information at the center is becoming difficult as its databases grow to a colossal size. GenBank, for example, contains more than 22 million nucleotide sequences. IBM said its Web services technology allows scientists to do such things as narrow the search for useful genes related to a particular diagnosis in PubMed and retrieve the nucleotide sequences in GenBank. Web services is the name given to many Web-based standards and protocols designed to let organizations connect disparate applications and share data. IBM's Web Services for Life Sciences software is available for download through its AlphaWorks Web site. The life sciences field is seen as a fertile one for information technology providers. Market research firm IDC estimates that IT spending for biosciences will jump from $12 billion in 2001 to $30 billion in 2006. IBM says its life sciences division is its fastest-growing unit. Formed in 2000, the division enjoyed triple-digit growth last year.   ]]> <![CDATA[Amrutanjan turning aggressive in Biotech]]> https://biospectrumindia.com/news/95/1551/amrutanjan-turning-aggressive-in-biotech.html https://biospectrumindia.com/news/95/1551/amrutanjan-turning-aggressive-in-biotech.html Fri, 16 May 2003 17:31:00 +0530 Amrutanjan, a Chennai based company, which is in to herbal products is moving in to biotechnology. S Radhakrishna, MD of Amrutanjan, says that it was a part of the diversification process. In biotechnology the company is focusing on the cloning and expression of Recombinant Therauputic Protein. As part of the expansion into biotech research, Amrutanjan is constructing its R&D Biotech unit in the SIPCOT industrial park, which will be completed by the middle of this year. The unit will have facility for protein downstream processing, work related to molecular biology, tissue culture, mammalian cell culture etc. Made with an investment of Rs 3.5 - 4 crore, the size of facility is 10,000 square feet. The R&D facility will be open to other contract services as it intends to operate it as a semi-commercial facility. Besides the coming up of the R&D facility at the SIPCOT Park, Amrutanjan has major plans coming up by the middle of this year. Very soon Amrutanjan will enter into the business of marketing Brucellosis, an animal vaccines that will prevent abortion in the cattle. Brucellosis, according to Dr S Kumar, Chief R & D - Biotechnology Division, Amrutanjan Limited, will have a very good market in India for the vaccines currently available in India cause many side effects. "We have a strong network of 2,500 channel players through whom we will market the vaccine. It looks like a deviation from our main activity, but ones we realize the potential of this vaccine we intend to produce this here itself." A US-based company is manufacturing Brucellosis, the details of which the company is not ready to disclose now. By mid 2003, Amrutanjan will be venturing into bioinformatics training course, for which it has sought affiliation with Madurai Kamraj University. The course has been started to benefit its in-house R&D activities. "Not only that most of the bioinformatics course available does not stress on the WetLab activity, which is a crucial aspect," added Dr Kumar. The five month course costs Rs 35,000. Molecular Diagnostics Services is yet another endeavor, which is in the pipeline from the company. To be functional by the middle of this year,it has invested Rs 25 - 30 lakh in this project. The company intends to use the Polymerase Chain Reaction (PCR) method for testing infectious diseases and for cancer testing. Most genetic disorders have to be looked at the DNA level or the protein level. Amrutanjan is looking at the DNA level since it is quicker and is considered to be more stable. This project from Amrutanjan is being positioned as a part of the company's social responsibility program to serve the community and especially the economically weaker sections of society. As part of this project, Amrutanjan will be setting its first testing center in Chennai to be followed by sample collection centers through out Tamil Nadu. A known name in every household, Amrutanjan is an analogue for instant relief whether it be from backache, body ache, sprain, cold, cough etc. One has come across Amrutanjan in various forms as in Amrutanjan Strong pain balm, Cold Snap Gel, Mridul Cough Syrup, Yellow pain balm etc. Established in 1893, Amrutanjan has always stood for herbal products by making use of the latest emerging scientific advancements matched with age-old tradition. In 1977 they started R&D Fine Chemicals under the stewardship of late Prof. TR Govindachary and late Dr BR Pai. Fine Chemicals is into making drug intermediates, which are being send to the domestic as well as Europe and the US markets. ]]> <![CDATA[IFF records highest export of Vanilla from India]]> https://biospectrumindia.com/news/95/5943/iff-records-highest-export-of-vanilla-from-india.html https://biospectrumindia.com/news/95/5943/iff-records-highest-export-of-vanilla-from-india.html Fri, 16 May 2003 17:23:00 +0530 International Flavors & Fragrances India Ltd (IFF), the Indian arm of the world's leading manufacturer of flavors and fragrances International Flavors & Fragrances Inc has recorded $2 million export in vanilla beans this year, thus becoming the single largest exporter of cured beans of vanilla from India. Though most of the company's export is made to its parent company based in the US about 10 percent of it goes to the retail market in the UK. IFF was the first to project India on the world map as an exporter of vanilla beans by making its first sale in 1991. The worldwide market for vanilla is estimated to be around the $200 million mark. With Madagascar and Indonesia topping the list as the leaders in vanilla exporting nations, the Spices Board of India is now targeting to place India in the top three rankings. "Currently we are in the business of exporting the cured beans of vanilla. We want to get into making the essence", says Jyothi Ramamohan, general manager, R&D, (Natural Products & Biotechnology), International Flavors & Fragrance India Ltd. The demand for both the beans and the essence in India is not very significant since synthetic products are available here at lower costs. "Just because of the availability of poor quality products, the rest of the manufacturers of vanilla could only contribute Rs 30 lakh in export revenue whereas we exported worth $2 million ," added Ramamohan. IFF India has around 200 descriptions of vanilla and it has exported nearly 50 tons of vanilla over three years. The Spices Board has given the company the citation of excellence in Spice Exports. The R&D unit of IFF is now focussing on natural aromatics. As of now IFF has made 14 aromatic products. IFF is not into gene manipulation, which according to the company is not organic and would rather manufacture products through the tissue culture process. IFF India was initially Bush Boake Allen Inc, a global producer of fragrances, flavors and aromatic chemicals. In the year 2000, International Flavors & Fragrances Inc acquired Bush Boake Allen Inc. ]]> <![CDATA[Studies reveal higher yields of GM hybrid mustard]]> https://biospectrumindia.com/news/95/2219/studies-reveal-higher-yields-of-gm-hybrid-mustard.html https://biospectrumindia.com/news/95/2219/studies-reveal-higher-yields-of-gm-hybrid-mustard.html Fri, 16 May 2003 17:20:00 +0530 According to independent studies carried out by the Indian Council for Agricultural Research, the genetically modified hybrid mustard seeds provide higher yields than the best comparable non-modified seeds across different regions. It is estimated that using these hybrid seeds will result in higher mustard oil production, giving the farmer more income of at least Rs 3,000 a hectare. These seeds have gone through nine years of research and extensive tests in fifty locations across five states. Given India's poor productivity of mustard seeds, with a national average of 941 kg/hectare, against an international average of double this amount, it is important to take all steps to increase India's productivity of this important crop. Increasing domestic production of mustard oil is important because India imports a lot of edible oil (in 2001-02, imports totaled more than Rs 6,500 crore). The Indian Farmers and Industry Alliance (IFIA) believes that any step that will result in higher domestic production of edible oil needs to be encouraged. IFIA recognizes that mustard is consumed by humans, whereas cotton is not. However, it says that studies conducted on GM mustard have shown that the crop is safe and that it has the same nutritional parameters as ordinary mustard. IFIA says, "India's biotech industry has now reached take-off stage. A lot of research is taking place; investments are flowing into the sector; governments, especially state governments, are backing biotech in a big way. However, regulatory barriers still remain that prevent the sustained growth of this industry. Clearing GM mustard will send a big signal to India's biotech industry that the hard work of Indian scientists is translating into products that are profitable both to their users and to the companies, both Indian and foreign, that invest in research and production." ]]> <![CDATA["Genomics is changing the face of biology"]]> https://biospectrumindia.com/news/95/2657/genomics-is-changing-the-face-of-biology.html https://biospectrumindia.com/news/95/2657/genomics-is-changing-the-face-of-biology.html Fri, 16 May 2003 17:16:00 +0530 The development and application of genome sequences and enabling technologies will lead to the removal of road blocks to progress, said Dr Manju Sharma, secretary, Department of Biotechnology, Ministry of Science and Technology, government of India. Delivering the keynote address at the 37th convocation of University of Agriculture Sciences, Bangalore, Dr Sharma said the genomic technology would enable the discovery of novel plant functions previously obscure to conventional genetic and biochemical analysis. Apart from that the technology will enable the discovery of novel signaling molecules, including peptide and other small molecules responsible for intracellular, intercellular and inter-organismal interactions. The mechanism for biosafety protocols, risk evaluation methods, awareness about patent issues, ethical, legal, social implications (ELSI) of biology of genomics are in place and what we require is the continuous investment for growth, she said. In this regard, the Department of Biotechnology is supporting the institutes and universities doing research in biotechnology. "Genomics is changing the face of biology. At first glance it is largely a change of scale when we move from considering hundreds or thousands of genes at once. Genomics research is providing bridges between different branches of natural sciences," Dr Sharma said. Explaining the scope of understanding genomics, she said, all biological research largely has been permeated by genomics. "New ways of tailoring crops for the economical production of grains, vegetables, fruits, fibers, herbal medicines etc., are emerging. The world is on the eve of a bountiful harvest to mitigate the hunger, malnutrition and heralding a novel health care regime on an environmentally sustainable basis keeping in view that environment is our most precious natural resource, " she said. ]]> <![CDATA["India has a big talent pool in life sciences"]]> https://biospectrumindia.com/news/95/1063/india-has-a-big-talent-pool-in-life-sciences.html https://biospectrumindia.com/news/95/1063/india-has-a-big-talent-pool-in-life-sciences.html Fri, 16 May 2003 17:14:00 +0530 Cost effectiveness, big talent pool, and a large population in India has made the country attractive for the investors to look for conducting clinical trials, health care and life sciences areas, said Mukundan CV, general manager, life sciences division, SysArris Software Pvt. Ltd. Speaking to BioSpectrum, he said, "it will take time for a developing country like India to get more funds. This is mainly because the sector is still in a disorganized shape as against the chain of networks in the western world. From drug discovery to the end application, the drug takes a proper channel, that makes a lot of difference. However, the process of drug discovery, clinical trails and development of genomics, proteomics takes a long period and require huge investments. It is only because of these factors the investors are not coming forward for investments in India. "But we cater to the entire drug discovery and development process from genomics, proteomics and screening to data management tools for pre and post clinical trials registration and post marketing adverse reaction tracking, " he added. ]]> <![CDATA[SysArris to open offices in Europe]]> https://biospectrumindia.com/news/95/1674/sysarris-to-open-offices-in-europe.html https://biospectrumindia.com/news/95/1674/sysarris-to-open-offices-in-europe.html Fri, 16 May 2003 17:09:00 +0530 To develop our business we are in the process of opening new offices in Europe and Germany. By end of this quarter the process will be over, said Ajay Simha, director, SysArris Software Pvt Ltd. Talking to Biopectrum Simha said we started our Indian operation in 1993. Since then our main focus was on exports. But only in the last couple of years we are looking at the Indian Market. The software developed by our team of 35 with functional knowledge in both biology and software skills is used in pharmaceutical /biotech companies around the world, he added. Companies like Amgen, AstraZeneca, Boots Healthcare International, Pfizer International, Parke-Davis - are some of the customers of SysArris. Operating from USA, SysArris has channel partners in Australia and Hong Kong to meet the requirements of the customers of Asia-Pacific region, Simha said. "We have been following the need-based approach and utmost care is taken towards the customers' satisfaction. SysArris would leverage on its core strength both in functional and software areas. Besides the functional knowledge on life sciences the team has knowledge of the drug validation process. And decades of experience with the pharmaceutical industry and biotechnology expertise ensures us to provide a complete bench -to bottle software solutions for our clients," he noted. "We have adopted an integrated team work effort and offer solutions in data mining and visualization and for gene discovery programs, functional genomics, recombinant DNA technologies, targeted research or pharmacogenomics using advanced programming methodologies and accurate algorithms resulting in accelerated throughput and maximized solutions. From developing software to analyze and manage complex biological information and accelerate the drug discovery process, we assist pharmaceutical companies in all phases of the drug development cycle. And also provide solutions for optimizing images that are captured during various experiments like HTS, Microarray and other related spotting experiments for biotech needs," he added. ]]> <![CDATA[ClinTec planning to launch training program in India]]> https://biospectrumindia.com/news/95/2924/clintec-planning-to-launch-training-program-in-india.html https://biospectrumindia.com/news/95/2924/clintec-planning-to-launch-training-program-in-india.html Fri, 16 May 2003 15:29:00 +0530 ClinTec India is planning to launch training programs for Indian students in clinical trials in the next few months. Rabinder Butter, founder president, ClinTec International, told BioSpectrum that ClinTec is planning to conduct courses ranging from foundation to post graduate diploma. To maintain the standard of the curriculum, she said, we would adopt the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and good clinical practice (GCP) standards, which is recognized by the representatives of the European Union, the USA and Japan for our training program. "Clinical research is very serious business. It needs skills to do the trials, understanding of the guidelines, proficiency in conducting or doing the trials," she observed. She said that even though India has set its own guidelines for conducting clinical trials reports say India will welcome the firms which follow the ICH-GCP guidelines. Other developing countries are also waiting to adopt the ICH-GCP standards while conducting clinical trials in their countries. Briefing about the program, Butter said, the program will be affiliated to a British University. The training program in India will improve the chances of getting the jobs for Indians in clinical trails the world over. "We want to promote education in clinical trials by conducting training programs and workshop for nurses, doctors and others. We are also discussing with some Indian colleges," Bhutter noted. ClinTec International that has database of the physicians, who are qualified for taking up the clinical trails in Europe, is strong in Europe and USA. It has 22 projects from 16 countries such as Poland, France, Germany, Netherlands, United Kingdom, Israel, Slovakia and Hungary. At present the Bangalore based ClinTec India is working on clinical writing and European projects. We are talking to private hospitals in India, which are committed to meet the standards of the ICH-GCP for conducting the clinical trials in the country, she said. ]]> <![CDATA[White collar farmers]]> https://biospectrumindia.com/news/95/2138/white-collar-farmers.html https://biospectrumindia.com/news/95/2138/white-collar-farmers.html Fri, 16 May 2003 14:46:00 +0530 Agriculture is a vast and diversified field offering numerous career options. Other than those directly engaged in farming and other agricultural activities, the biotech industry needs people in the areas of research and development and also in various other agri-biotech related fields. There are specialized areas with good career prospects like horticulture, floriculture, dairying, poultry farming and fishery. One can specialize in food processing or post harvest technology or GM (genetically modified) technology. The fields in agriculture based biotechnology include biopesticides, biofertilizers and biofuels. Agriculture currently accounts for a fourth of the gross domestic product (GDP) and employs more than two thirds of the labor force in the country. It meets our basic need for food and also the requirement for most of the raw material needed by the manufacturing sector. Science and technology have contributed significantly to agriculture in terms of improving productivity and quality. In order to gain a footing in the highly competitive global market and to make major gains in the export market, there is an increasing demand for professionally qualified people in this sector. Agriculture based biotech industry needs people who are qualified in the field of molecular biology, plant transformation and tissue culture, biochemistry, plant genetics, pathology, entomology and agronomy for trait evaluation and integration. One can join the sector as a microbiologist for developing microbial products for plant growth enhancement or as a statistician or as a bio-metrician. The major share of the research and development in the public sector is carried out by the Indian Council of Agricultural Research (ICAR) which works on cereals, pulses, vegetables and floricultural crops by funding about 200 projects in 15 institutions and 28 universities. There are more than 75 ICAR institutes dedicated to research on different products. The Department of Biotechnology has invested substantial amounts in research and development in biotechnology. The National Research Center for Biotechnology at the Indian Agricultural Research Institute (IARI), New Delhi, focuses on plant genetic engineering related research activities to boost agricultural production. Both private and public institutions are developing hybrid tomato, brinjal, transgenic plants, tissue culture technology, seed technology and bio-pesticides. Hybrid seed technology is a way to combat the shortage of food grains evolved by the ever-increasing population. The hybrid seed technology for sunflower, rice, wheat, corn, tomato and vegetables is currently under development. Development of disease resistant plants, cloning genes for floral meristem initiation and tagging genes of agronomic importance are the other major projects being done in both private and public sectors. According to a Biotech Consortium India Ltd (2001) report, there are a total of 176 biotechnology based companies in India. As many as 49 per cent of the companies are agriculture-based companies having interests ranging from tissue culture to bio pesticides. Almost 25 per cent of the companies are active in health related activities and are in medical sciences while 24 per cent have varied interest including environmental biotechnology. Although in terms of numbers, health biotechnology companies are lesser than those active in the agriculture sectors but they account for a much higher proportion of foreign alliances. "Being a science based industry, we look for highly qualified people like Ph.D.s with experience (in some instances), ability to work in a team, ability to teach others and learn from others, share credit, ability to be flexible and adaptable to changes," says an official at Monsanto. Monsanto is one of the global leaders in the field of biotech based agricultural solutions. Monsanto in India has its corporate office at Mumbai. The company's research wing in Bangalore employs 45 agricultural scientists. Experts say that by 2020 India can become the world's largest exporter of agro-commodities thanks to the R&D efforts in the agri-biotech industry. The country, which is the world's second largest producer of fruits and vegetables, stands to benefit greatly from plant biotechnology. There are about 50 private companies in the field and the total seed market has been estimated as Rs 7,500 crore in the year 2001. According to an Exim Bank report, about 400 organizations are doing commercial research in agriculture, which include 200 research labs, 150 companies and 50 service firms. Some medical food and neutraceuticals are also under development. The foreign direct investment norms at present permit (under the segment of agricultural production and plantation) foreign investors to use the automatic route if the foreign equity limit is 51 percent. Monsanto, Proagro, Hindustan Lever, Dupont, Indo-American Hybrid seeds, Advanta India, Hoechst Schering AgrEVO-PGS, Pioneer-Hi-Breed, SPIC, Novartis, AV Thomas, EID Parry, National Organic Chemical Industries Limited, Rallis, Cadila Plant Biotechnology and Godrej Biotech are active plant biotech companies in India. Monsanto, which is expanding its Indian subsidiary, has a seed joint venture with Mahyco. "The scope of agriculture based biotech industry is tremendous. This field is developing day by day and it seems that there is no dearth of trained manpower in the field of agriculture based biotech industry, as there seems to be so many around with diverse qualification and background," says Deepak Mallik, CEO, Advanta India Ltd. The department of biotechnology (DBT) is supporting 23 M.Sc. courses in general biotechnology, four in agricultural biotechnology, one each in medical and marine biotechnology and a couple of diploma courses in molecular and biochemical technology. The total intake of students in the various post-graduate courses supported by the DBT in the country is around 550 per year. As a part of the restructuring of the post doctoral research and training program, DBT has scraped the existing programs with different institutions and has given this responsibility to the Indian Institute of Science (IISc), Bangalore. This is to ensure competitive attitude and quality output in the life sciences. IISc would award up to 75 fellowships of two-year duration in different streams of biotechnology. DBT is also supporting overseas associateship and short-term training courses for at least 22-25 scientists in a year to expose Indian scientists to newer trends in R&D. This helps working researchers and scientists to upgrade their knowledge and research areas of interest "We have employed about 60 agricultural scientists in Avesthagen and we recruit passing out students from the academia. They need rigorous training to be reshaped to fit the industrial bill. We have an international scientific advisory committee that pulls us up on this score every year. Right now we have with us Dr David Frisch from the US who is training our personnel on genome sequencing and studies. Each individual in Avesthagen needs to have at least an idea of the issues interphasing the special field he or she deals with. Here we are not doing science for an altruistic cause; we mean serious scientific business which sells. The scientist needs to have an understanding of the basics of finance and the accountant should have some idea of the science, and the legal person has to be equipped with the fundamentals of science. It is a unique melting pot which needs a special training no matter what the qualification is. And finally the interpersonal skills which gives the individual the capacity to learn, to mould, to change is what's most important," says Villoo Morawala-Patell, founder and CEO of Avesthagen. The Tamil Nadu Agricultural University at Coimbatore offers M.Sc. and Ph.D. programs in agricultural biotechnology. Every year the university takes seven students for the doctoral program. The Bioinformatics Center at the Department of Plant Molecular Biology and Biotechnology at the university is one of the Information Sub-Centers under the Biotechnology Information Systems (BITS) program of the DBT. The thrust areas taught in this center, equipped with state-of-the-art hardware and software, are plant molecular biology and biotechnology. The Bangalore- based University of Agricultural Sciences is offering M.Sc. in Agricultural Biotechnology for students who have completed the BSc program in agriculture or horticulture from the same university. The two year program includes subjects such as plant molecular biology and biotechnology, principles of recombinant DNA technology, biotechnology for plant micro interaction and the practical papers like computer application in biotechnology, methods in biotechnology. The students have to submit their research papers in the second year. Top Bioagri companies in India    Company                                                                        Locations 1 Monsanto India   Mumbai 2 Hindustan Lever                                                                      Mumbai 3 Dupont Gurgaon 4 Maharashtra Hybrid Seeds Company (Mahyco)-Monsanto  Mumbai 5 SPIC Hybrid Seeds Transgenic Crops Chennai 6 Rallis India Ltd Mumbai 7 Proagro -PGS India Ltd  New Delhi 8 EID Parry (India) Ltd Chennai 10 Godrej Plant Biotech Ltd  Hyderabad 11 Sun Agro Industries Ltd                                                         Chennai 12 Advanta India  Bangalore 13 Indo American Hybrid Seeds(India) Pvt. Ltd  Bangalore 14 White Field Agro Tech Pvt. Ltd Bangalore 15 AG Biotech Laboratories (India) Ltd Hyderabad 16 Biotech International Ltd  New Delhi 17 Biotissues Pvt. Lab. Ltd  Habsiguda, AP 18 Cargill Seeds India Pvt. Ltd Bangalore 19 Bharat Starch Industries Ltd  New Delhi 20 Ajay Biotech (India) Ltd Pune "Bioagri is a boon to the country to fulfill the domestic needs in the foodgrain sector. The department of biotechnology in our university, since its beginning in 1996, has added more students to its list. Every year 17 students are pursuing the M.Sc. (Agriculture Biotechnology) at the department," said Dr AM Krishnappa, vice chancellor of the University of Agricultural Sciences, Bangalore. The research institutes and research-based companies require more people in this sector. Indigenous efforts in this sector are also flourishing in a number of government and university laboratories. For instance, greenhouse and field tests on insect-resistant brinjal, cabbage, rice, cauliflower and tomatoes are underway at the Indian Agricultural Research Institute (IARI), New Delhi. " Our students are getting placement in several biotechnology institutes, institutes like IARI and companies like Monsanto," says TKS Gowda, the head of the department of biotechnology, UAS, Bangalore. There are 29 agricultural universities spread in different parts of the country. In addition to these there is the Indian Agricultural Research Institute in New Delhi, Indian Veterinary Research Institute in Izatnagar (Bareilly), the National Dairy Research Institute in Karnal and the Central Institute of Fisheries Education in Mumbai, all of which fall in the category of deemed universities. Addressing a two-day conference of vice-chancellors of agriculture universities, the Union minister for Agriculture, Ajit Singh asked the universities to forge closer ties with industry and commercialize their technology to raise funds. He also stressed the need to commercialize agricultural education to keep pace with rapid privatization. The agricultural education system in the country offers degree programs in 11 specific disciplines viz. agriculture, veterinary science, agricultural engineering, forestry, home science, dairy technology, fisheries, sericulture, marketing, banking and co-operation, horticulture and food science with a total intake of about 11,000 students every year. It also offers postgraduate programs in more than 55 fields of specialization with a total intake capacity of about 5,000 students. ICAR offers about 1200 scholarships and fellowships from the undergraduate to post-doctoral levels. Agricultural biotechnology is a collection of scientific techniques, including genetic engineering, that are used to create, improve, or modify plants, animals, and microorganisms. Biotechnology enables reshuffling and manipulation of genes that is not likely to happen in nature to open up a vast new source of genetic diversity for crop improvement. It provides a set of tools that, if appropriately integrated with other technologies, can be applied for the sustainable development of agriculture, fisheries and forestry, as well as the food industry. Biotechnology includes a wide array of techniques and applications. Examples include micro propagation, allowing for multiplication of virus-free plants; marker-assisted selection applied to conventional breeding, or genetic engineering, for the production of genetically modified organisms with new, improved traits. ]]> <![CDATA[The BT Agenda]]> https://biospectrumindia.com/news/95/2998/the-bt-agenda.html https://biospectrumindia.com/news/95/2998/the-bt-agenda.html Fri, 16 May 2003 14:41:00 +0530 Fact one: The pottential of the Indian BT Industry has not yet been translated into reality. Fact two: There are no stupendous success stories as yet. Are we being impatient with the BT industry? Ask the VCs and they will say that they can't afford patience. They want success, they want heroes and they want exits. One can argue that the great opportunity for BT is in the future. But is the future far away or is it tomorrow? The Indian BT industry needs to get its act together sooner rather than later. Last month in BioComment, we talked about the need for India to drive the Biotech bus and not just catch it. The great Indian BT opportunity will become a reality only if we are in the driver's seat and not let ourselves be driven. The Indian BT industry needs to work out an agenda for itself, then convert the agenda into measurable milestones and lastly find the driver for driving the agenda. Agenda setting can be a minefield with the objectives of various players coming in the way of each other. The case of the BT industry is further complicated by the presence of divergent segments like agriculture, pharmaceuticals and informatics. A common agenda set could include industry mapping, policy matters, confidence building amongst investors, strengthening the education and research aspects, creating the India BT brand abroad and user awareness within the country. For a relatively new industry, the need for industry mapping is important. One may not even know the total number of players let alone what their activities are. Mapping helps in sizing the industry as various pieces of the industry fall into the BT puzzle. Another advantage of industry mapping is that it builds the BT fraternity and leads to the formation of industry forums. Is the government helping the industry or playing spoil sport? Set up in 1986, the DBT has undertaken several measures to foster the growth of the BT industry in India. But does the industry want more from the department? The BT industry in India needs a policy group to interact with the government. Governments all over the world work with industry groups to determine policies that would aid the growth of the industry. A common policy document needs to be drawn up by the BT industry that would help create the policy framework. Funding is a major consideration for the BT industry. The volume of venture capital funding in the BT sector has not been on the upward curve for the last two years. India does not have a single biotech only fund compared to close to 100 biotech funds in the US. So the Indian BT company goes to the multi-sector funds most of whom do not have biotech as an investment priority. Considering the fact that the BT industry is in a nascent stage, seed funding is the order of the day as it would facilitate the entry of new players. Unfortunately most multi sector VCs do not want to do seed funding. They demand demonstrated capabilities. Tackling expectation mismatches like these has to be on the agenda of the BT industry. If the VCs are not willing to fund, the finance group of the industry has to pave the way for alternate funding sources. The availability of human capital is significant in BT due to the great deal of research that is involved. It would not be out of place to state that success for the BT industry is largely based on the strengthening of research and education facilities all over the country. When asked about the areas of BT that India needs to invest in, "Gene Mapper" Craig Venter was categorical when he replied that the best investment is to improve the quality of education and research work. World class skills will automatically open up the global market for the Indian BT industry. India will evolve as a brand to be reckoned with for services like contract research and clinical trials and for manufacturing products for the global market. The industry has to chalk out a very clear agenda for marketing the India brand. Projecting India as a cheaper destination to get work done can become counter productive. The fruits of BT research and work gets consumed by humans and not by machines. Vested interests in other countries will be quick to point out the importance of GMP, GCP and GLP and question India's adherence to such good practices. User awareness about BT applications has to increase within the country also. Bt Cotton has had its share of bouquets and brickbats and the debate isn't quite over. What it is certainly leading to is a delay in the introduction of more Bt crops and a perception about Bt based on incorrect assumptions. The industry needs to involve NGOs and user groups in informing farmers and the public at large the benefits of BT. The industry has to realize that the domestic market for BT applications is large, in fact very large. The agenda can be sequenced and modified. But what is mandatory is that the Indian BT industry must have an agenda and identify the various priorities before it. The industry must seek to set a pace for itself and move ahead from a pilot project stage into a full fledged industry. There is a need for the industry and government to work together for covering the agenda items in quick time. Who will enABLE that? Abraham Mathew abrahamm@cmil.com (The author is the Chief Editor of BioSpectrum) ]]> <![CDATA[A billion dollar opportunity unfurling]]> https://biospectrumindia.com/news/95/2212/a-billion-dollar-opportunity-unfurling.html https://biospectrumindia.com/news/95/2212/a-billion-dollar-opportunity-unfurling.html Thu, 17 Apr 2003 12:24:00 +0530 Agriculture is an ever-shine growth area. After all, the number of people to be fed decent meals increase every year. The nation now has mountains of food grains in its godowns, 48 millions to be precise. But the pile up has occurred due to lack of purchasing power and not due to declining demand. And with production dipping in the last two years due to drought, there is an urgent need to increase productivity. Modern technologies, new farm practices, genetically modified seeds, bio-pesticides and fertilizers, and high-yielding hybrid varieties are looked upon as saviors of the farmers. We are entering the age of biotechnology products. The bioagriculture market is looking up. A recent Confederation of Indian Industry (CII) study has predicted that the agribiotech would grow rapidly in the next five years and would account for at least 15 percent of the total indigenous market. Its current share is around two percent. Among the biotech companies, the agriculture sector accounts for 24 percent. Agribiotech share is expected to touch 33.7 percent of the total biotech companies in a few years. The table gives a clear picture about the future consumption of biotech products in India. Deepak Mallik, CEO, Advanta India Limited, an agri-biotech company based in Bangalore, has a different viewpoint. "BioPharmaceutical is the leading sector in biotechnology industry in India. The contribution of biopharmaceuticals is 75 percent and bioagriculture is 25 percent. In terms of business potential, biotechnology based agriculture industry has tremendous scope in the country as agriculture is the back bone of the country with over 70 percent of the population depending directly or indirectly on it." Consumption of genetically modified (GM) plants/seeds are expected to increase in the coming years. This would offer the opportunity of investments to the tune of Rs 1500 crore in the next five years in specific sectors of seed industry. Field experiments have been initiated for evaluating the environmental risks and human health. Initial results have not shown any unmanageable risks either to environment or human health. Indeed the good news is that there has been significant rise in the agronomic benefits, besides reduction in the use of chemical pesticides for plants engineered for resisting the attack of insect pests. In addition to the high yielding hybrids/ varieties, farmers are have started using the GM seeds in cotton. The first GM product, the Bt cotton was permitted for use in India in March 2002. Monsanto's Bt cotton has been planted in some 40,000 hectares in the first year. The results of the first crops of Bt cotton are mixed with farmers not realizing the full potential. However, experts attribute this below par performance to other factors such as drought. A national debate is now on about the efficiency of Bt cotton crop. "Since biotechnology is new in the country, it is necessary to educate the public about this technology. Public must be aware about the benefits. Government, as well as other players in the field, have to take initiatives. This can be done through a variety of mediums ranging from scientific seminars to inclusion in school curricula", says Dr TM Manjunath, director Monsanto Research Center, Bangalore. Besides cotton, we may find GM seeds in maize/corn, mustard, soyabean and rapeseed by 2005. It is estimated that the Indian farmers may use two tons each of GM maize/corn, mustard/rapeseed, soyabean seeds out of 1000 tons of all types of seeds by 2005. Besides the private sector seed companies, many government funded institutes and organizations are also getting ready with transgenic crops of rice, rapeseed/mustard, potato, brassica, moonbean, pigeonpea, cotton, tomato cabbage, and cauliflower. The process of field assessment of some of these crops is likely to be completed in few years and some of them would be ready for commercial production by 2005. It is also expected that a protein rich wheat with a higher lysine content will also be introduced in the farmer's field soon. Indian research efforts in developing a trasnsgenic rice variety is also going on well as part of a global effort. Indian scientists have sequenced 2.7 mega bases (Mb) of chromosome-11 in rice. India's commitment to sequence 10 Mb of chromosome-11 in five years is expected to open the market opportunities for private companies. Global companies like Monsanto, Bayer Crop Science, Dow Chemicals, Du Pont, Syngenta, BASF dominate the agribiotech sector in India. These were the first companies to introduce a host of GM products in tomato and cotton. They have huge market and mind share and leverage every opportunity to extend their intellectual property rights (IPR) to Indian market. Mahyco is a major Indian players in the GM seeds market. A recent study by Rabobank India has predicted that seven more Indian companies were expected to become players in the GM seeds market. These are: Mahendra and Paras of the Emergent Group, Nath Seeds, Ankur Seeds, Ajeet Seeds, Raasi Seeds, Krishi Dhan and Nuziveedu Seeds. These companies may release Bt cotton hybrids by 2006. Nath Seeds is sourcing the gene from the Biocentury Transgene Company, China while others are licensing it from Monsanto. However Prof. M D Nanjunda Swamy, prominent farmers' movement leader has a different view. He says, "agriculture biotechnology is devastating one. The failure of Bt crops has forced many farmers in Maharashtra, Gujarat and Andhra Pradesh to take drastic steps. Considering these facts, I would urge the Government of India to encourage the use of traditional crops instead of GM seeds." Sush a statement need not lead to any panic. The bioagricutlure provides opportunities in other sectors such as biofertilizers, biopesticides and bio fuels, where biotechnology has tremendous applications. Bio-fuel With the world experiencing an energy crisis, the search for alternative fuels has been on. Biofuels offer an attractive opportunity to conserve and economise conventional fuels like petrol and diesel. Biofuels are being used as admixtures with conventional fuels at levels that do not require modifications of Internal Combustion (IC) engines. Pure biofuels can also be used. However, this requires a modification of IC engines. In general, blends containing 25 percent biofuels can be effectively used, resulting in lower cost of fuels, nearly half of petrol costs with low polluting emission characteristics. Ethanol in sugar molasses is used as a raw material to produce gasohol, petrol blended with 5 percent ethanol. It is beneficial to the country as a whole, besides the farmers, the sugarcane related industries and the environment. Benefits of agri-bio Feeding a Growing Population: hunger is a complex issue and biotechnology is among the approaches to address this challenge Benefits for the Environment: discoveries will allow certain key crops to have their own protection against insects and disease Nutrition, Quality and Taste: research into numerous improved food products include food crops with higher levels of nutrients, vitamins and antioxidants. The better balance of amino acids (in proteins) and fatty acids (in oil and fats) will better the nourishment and may also help to reduce the risk of heart disease and certain cancer. India being a major sugar producer in the world with production of 18.51 million tons in 2001-02, the total supplies of sugar during the year stands at 28.2 million tons, (with a huge stock of 10.7 million tons by the end of the crop season in September 2002). But the offtake in the local market is 16.5 million tons during 2001-02 leaving a surplus of 10.7 million tons. Looking at this, the ministry of petroleum has decided to supply gasohol to cover the entire area of nine states and four Union Territories fully by June, 2003. The project was launched last January. Though oil companies have completed their arrangements in this regard, the state governments other than Maharashtra and Uttar Pradesh could not develop the infrastructure to produce anhydrous ethanol and sought more time. As the current total consumption of gasoline in these states and union territories is about 4.6 million tones per year, the requirement of ethanol at 5 percent blend ratio works out to 320-350 million litres. So the scope in biofuel sector is very big. That not only helps the sugarcane farmers, but also helps in building up the oil security apart from benefiting the environment. It also saves the country's foreign exchange in the tune of Rs 80,000 crore as India imports about 70 percent of the its requirements of crude oil. The farmers gain with better returns as sugarcane finds a new avenue since ethanol is produced from the sugarcane molasses hitherto going waste. The emission of pollutants are lower from ethanol-blended fuels as ethanol acts as an oxygenate helping better combustion. Bio-fertilizers and pesticides Bioagri sector is looking up from the increasing use of biofertilizers and biopesticides. Formulations based on Bt, viruses like NPV and GV as well as neem-based pesticides are finding more takers. Experts predict that to meet the increasing demands, industry would have to scale up their investments. Rough estimates show that the level of investments required are : Rs 20 crore in biofertilizers, Rs 50 crore in pheromones, growth stimulants /promoters and Rs 60 crore in botanical pesticides. The integrated nutrient management (INM) program initiated by the Department of Biotechnology at 17 centers has provided technology packages for many cropping systems. Through these studies, it has been established that a combination of biofertilizers resulted in significant increase in yield of crops and such packages could replace 25-30 percent nitrogen. There was a conspicuous improvement in soil structure due to combined application of organic matter. The CII has estimated an increase in the use biofertilizers in the next five years. The estimated consumption of biofertilizers â€” rhizobium, azospirillum and azotobacter â€” in 2000 stood at 11,200 tons against 10,470 tons in 1997. A 25 percent increase in consumption of these products to 14,900 tons is expected by 2005. On a conservative estimate, even a 10 percent saving through the use of biofertilizers is expected to result in an annual saving of 1.094 million tons of nitrogenous fertilizers costing around Rs 550 crore. According to CII, the prospect for Bio-pesticides sector in India is bright with the demand for biopesticides expected to increase to 200 tons by 2005 from 120 tons in 2000. Already 50,000 farmers have benefited through the training programs and extension held by government. Several bio-pesticide technologies have been developed on the basis of large-scale field efficiency. Patents have also been developed for the mass production technologies of biocontrol and their product formulations. Future Perfect The future of agri-biotechnology is very bright. The use of modern technology in the form of genetic engineering is helpful in producing crops that are pest-resistant and resistant against diseases and herbicides. Crops that are tolerant to drought, cold, salinity and other harsh environments can be produced. Of these, the first generation of biotech products comprising crops that are resistant to pests, diseases and herbicides have already been commercialized since 1996 and by 2002 these occupied 52.6 million hectares in 13 countries (including both developed and developing countries), cultivated by about 5.5 million farmers. The estimated global market for transgenic crops is projected to increase from $3 billion in 2000 to $25 billion by 2010. Dr AM Krishnappa, vice chancellor, University of Agriculture Science, Bangalore, is very optimistic about the future of biotechnology in agriculture. He says, "Bioagri is a boon to the country to fulfill its domestic requirements in the foodgrains sector. The scope for biotechnology in India is tremendous. But due to lack of funds and support from the government, it is difficult to run the show. My university's department of biotechnology since its opening in 1996 has added more students to its list. At present 16 students are pursuing the biotechnology course at the department. Though there is demand from the student community, the lack of infrastructure is not allowing enrolment of more students for the course. " On the scope of bioagri in India, Dr TM Manjunath, director, Monsanto Research Center, Bangalore, says, " India is predominantly an agrarian country with more than 60 percent of the population dependent on agriculture directly or indirectly. Our population has already exceeded one billion and it is expected to reach 1.5 billion in 2050. At the same time, resources like arable land, water and fertilizers are diminishing. Therefore, the challenge before us is to produce more food to feed the ever-increasing population with less land, water, fertilizers, labor and other resources. Biotechnology has the potential to offer solutions. Biotechnology will benefit a highly populous, agriculture dependent and a developing country like India than the developed countries. " Manjunath added that as biotechnology was new to the country, it was necessary to educate the public about this technology. Public must be aware about the benefits. Government as well as other players in the field have to take initiatives. This could be done using a variety of mediums ranging from scientific seminars to inclusion in school curricula. The Central Board of Secondary Education (CBSE) has introduced biotechnology as an optional subject in Class XI from June, 2002. Some 125 schools in the country are offering this option now. Kiran Mazumdar Shaw, chairperson and managing director, The Biocon India Group finds a very different future for biotechnology related to agriculture. "Agribiotech has a very questionable future largely because of the various sentiments about GM crops. I think we can make agribiotech in to a very big business. Companies should not concentrate on edible or nutrition products as they may encounter regulatory hurdles. Bt cotton is a good example. Using the same tech for growing of trees for paper production, or for the production of medicinal plants will have a different view point and that will push the sector to a greater extent." If the bioagri sector has to succeed, a lot of awareness campaigns have to be done to reach out to the farmers. The mixed results of GM crops in the first year of sowing may not exactly be the correct indicator of its potential. After all, the water stress and other environmental factors too may have played a role in the relatively low output. The potential of the crop, a harbinger of the new technology, should be monitored over a longer period before a final decision is taken. Narayan Kulkarn ]]> <![CDATA[Uplifting ayurveda medicine system]]> https://biospectrumindia.com/news/95/2441/uplifting-ayurveda-medicine-system.html https://biospectrumindia.com/news/95/2441/uplifting-ayurveda-medicine-system.html Wed, 16 Apr 2003 11:16:00 +0530 BioSpectrum peeps into the hallowed precincts of this well-known institution in Kerala to report about the transformation that is taking place at a frenetic pace It was a risky step. Because under the British rule, the allopathic system of medicine had started to make inroads into the Indian society. People were attracted by the 'magic' of instant cure offered by modern medicines. For, the rigorous, holistic regimes prescribed for ayurveda medicines required long gestation period to show results for many ailments. And many of these ayurvedic medicines had to be prepared through elaborate processes at home from a variety of ingredients. But Vaidyaratnam PS Varier seemed to have hit the winning note. Vaidyaratnam is a title meaning 'jewel among doctors'. Patients flocked to his medicine shop. Maybe because he gave them ready-to-eat ayurvedic preparations. The drudgery associated with home-based preparations was eliminated. Today, The Arya Vaidya Sala symbolizes the ayurveda system of medicine and Kottakkal is no more a sleepy town. People from all over the world flock to Kottakkal for a host of treatments. The Arya Vaidya Sala has now over 14 branches with hospitals and research centers, and countless marketing units. It has a turnover of around Rs 80 crore and exports substantial quantities of medicines to foreign markets. The good doctor's successors are not resting on the laurels. If readymade herbal medicine was the attraction of the Vaidya Sala in the early 1900s, in the 21st century, it is the biotech initiatives which are making news now. Experts believe that these initiatives offer a hope for reviving India's traditional system of medicine. "The Arya Vaidya Sala is moving in a big way with a plan to modernize Ayurvedic medicines through biotechnology," says AR Sankaranarayanan, general manager, Arya Vaidya Sala. However, it did not happen suddenly. In 1998, CSIR director -general Dr RA Mashelkar approached Arya Vaidya Sala with a proposal for collaboration in the Ayurveda sector. The idea was to sort out certain active principles behind individual ailments and new medicaments. Arya Vaidya Sala, as conventional practitioners of ayurveda, initially approached the project with a sort of scepticism and apprehension. Ayurveda as a medical system does not talk about single herbs; instead it talks about poly-herbal combinations. It was Dr MS Valiathan, a pioneering biomedical researcher, who intervened and convinced that they need not compromise on the conventional systems. He added that if they don't take the right step in this field, it would be a multinational who will walk away with the benefits by entering the field. And finally on February 1, 1998, Dr RA Mashelkar came to Kottakkal and the MoU was signed between CSIR and PK Warrier, the managing trustee and chief phycisian of the Arya Vaidya Sala. The MoU stipulated that based on the conventional knowledge, Arya Vaidya Sala would make an attempt to develop a modern medical treatment system which would be accepted universally as a therapeutics agent satisfying all global standards and quality. Getting global recognition is a key goal because no major country has so far recognized ayurveda or any other traditional systems of medicine for generic purposes. The Chinese medicine preparations too face the same problem in entering the markets in the developed countries. The Indian government has learnt its lesson from the patenting of the neem plant in the USA. It has recognized that Indian herbal remedies are much sought after in the West, and that there is a need to protect them. Instead of closing the doors on foreign biotechnology companies, the government has come up with a profit sharing mechanism to ensure that Indian communities benefit from the commercialization of Indian herbal drugs. The CSIR- Arya Vaidya Sala program aims to develop bioactive molecules and then establish the standardization procedures and improve the processing and preservation techniques of ayurveda medicines. Changing scenario Things may have started to change gradually. Recently Russia has recognized the ayurvedic system of medicine. India and Russia will soon sign a memorandum of understanding setting up ayurveda's Panchakarma treatment for victims of the Chernobyl nuclear disaster. This cooperative agreement was announced at the World Ayurveda Congress, held recently in Kochi. Kottakkal Arya Vaidya Sala will provide technical support for the venture. The U. K., Germany, France, Sweden, Austria, United States and Italy have launched schools of alternative medicine, which is primarily the Indian system of medicine. Additionally the World Health Organization has explored the potential of Ayurveda and found it efficacious in not just curing diseases but also for preserving health. "We provide some classical knowledge and classical materials, not raw materials but finished products, as per some classical formulations," said TS Murali, CSIR-IICT& DST Project Head. The standard protocol tests for vaccination is done at IICT (Indian Institute of Chemical Technology), Hyderabad and the CSIR lab screens the end products to check whether it has promising results. Preliminary research results indicate that a few molecules or herbal formulations with sufficient efficacy have been identified. The process is in progress to set up a pilot plant which is expected to be completed by September. The members of the CSIR-Arya Vaidya Sala project include the project head, who is a physicist, two physicians, a biochemist and five chemists. There is also a herbal quality control section, which has two wings. The first includes a group of physicians who decide the herbs depending on the classical specifications. The second group does the chemical analysis based on the pharmaceutical standards put forth by the government. The R&D department is also engaged in other kinds of in-house research like stability factors, setting up of new standards and trying to develop new medicines. The Vaidya Sala has set up three labs for R&D work. CSIR has short listed about 20 different disease conditions like cancer, ulcer, arthritis etc under this project. Efforts are also on to formulate memory enhancers and drugs that could be used in ailments related to central nervous systems. Clinical trials in cancer and rheumatic arthritis are being carried out at the charitable hospital run by the Vaidya Sala. The researchers here have collected patient data from about 900 cases. The data analysis process is now on. They have also set up a pain and palliative care clinic at the Calicut Medical College hospital. This is recognized as a model pain clinic by the World Health Organization for developing countries. The five-year project period is nearing its end. "We will mutually extend it for another five years," said the project head. Two of the molecules have already been identified. "More importantly we have found that is not the fraction but the original combinations that has an effect," said a team member requested anonymity. "This is a gratifying experience for us," he said. Arya Vaidya Sala is not just into popularizing of the ayurvedic medicines by modernization and standardization, but also into plant biotechnology research. The Arya Vaidya Sala cultivates medicinal plants at Kanjirapuzha and Kottappuram in Palakkad district on a large scale. To help the correct identification of herbs, a research garden was established on eight acres of land near the charitable hospital. This garden at Kottakkal has around 1000 medicinal plants. As an initiative in the plant biotechnology research, a project has been started with the support of the Department of Biotechnology (DBT) to establish a germ plasm bank for ayurvedic medicinal plants at Arya Vaidya Sala. Started in March 2002, the major objective of the project is to explore, identify, document and collect the rare, threatened and endangered medicinal plants used in Ayurveda and other systems of medicine from Kerala, Tamil Nadu, Karnataka and Andhra Pradesh. The project, which has a deadline of three years, will also study the extent of rarity of medicinal plants and their intra species variation. The Centre for Medicinal Plants Research of the Vaidya Sala is also setting up a gene bank of rare, endangered and threatened medicinal plants having components of in vitro and seed gene banks. Building up of a herbarium of dried plant twigs with all relevant information connected to their identification and setting up of museum of medicinal plants, which will serve the purpose of a library for the future reference, are also part of the project. "Our aim is to collect and protect rare and endangered medicinal plants. We have roughly short-listed 150 plants, with all accession details, to display in the germplasm bank," says Dr Indira Balachandran, principal investigator of the DBT Project. "The project has completed a year and we have already made quite a few collections from the primary sources as well as a few from the secondary sources" she said. The next step is to transplant them in June when the rainy season begins. A couple of green houses are ready for the purpose. It is important to avail the genuine medicinal plants for the future. "We are soon going to have a full fledged biotechnology division. We are going to appoint Phytochemists and biotechnologists probably by June or July, " added Dr Indira Balachandran. Lakhs of seedlings of rare medicinal plant species, which are not available easily, can be multiplied using micro-propagation techniques. The Kottakkal Arya Vaidya Sala has come a long way in the preservation and promotion of ayurveda by providing genuine medicines, treatment, education and research facilities for the benefit of the world. They could have continued in the same way. But then, the scope of popularizing ayurveda in the global market would not have come into existence. The Vaidya Sala looks at uplifting ayurveda to the status of cardinal health care system all over the world. And the biotechnology intervention will surely help it to achieve their goal. Legal hurdlesThough Indians have been using several indigenous systems of medicine, they have caught global attention only recently. Perhaps due to disenchantment with many allopathic medicines which cause innumerable side effects. The foreign tourist boom in Kerala and the hardselling of ayurveda has spawned new set of users for this sector. Yet, it is unlikely that ayurveda and other traditional Indian medicines will adorn the chemists' shelves across the world soon. For, the drug regulatory systems imposes rigorous quality standards on such products to ensure that they do not cause any harm to the consumers. In India, companies have launched many herbal remedies in the market. The Drugs & Cosmetics Act, 1940 (the "Drugs Act") and the Drugs and Cosmetics Rules, 1945 (the "Drugs Rules") prescribe the standards and quality, and regulate the import, manufacture, sale and distribution of all drugs including ayurvedic medicines in India. Under the Drugs Act, an ayurvedic drug includes all medicines intended for internal or external use for or in the diagnosis, treatment, mitigation or prevention of disease or disorder in human beings or animals, and manufactured exclusively in accordance with the formulae described in the authoritative books of Ayurvedic, Siddha and Unani Tibb systems of medicine, specified in the First Schedule" of the Drugs Act. (Section 3(a) of the Drugs Act) The Drugs Act prescribes a particular standard for manufacturing an ayurvedic drug for sale or for distribution. The drug manufactured should comply with the standards for identity, purity and strength as laid down in the editions of ayurvedic pharmacopoeia of India. (Section 33 EEB of the Drugs Act r/w Rule 168 of the Drugs Rules) The Drugs Act imposes strict standards and not every ayurvedic drug can qualify as an ayurvedic drug. In certain circumstances, an ayurvedic drug can be deemed to be misbranded under the Drugs Act if the drug is so colored, coated, powdered or polished so as to cause damage to the drug, the damage being concealed; or if the drug is made to appear of better or greater therapeutic value than it really is. (Section 33-E of the Drugs Act) Additionally, if the ayurvedic drug contains any harmful or toxic substances that may render it injurious to health; or if any substance has been mixed in it so as to reduce its quality or strength, then, in such an event the ayurvedic drug manufactured shall be deemed to be adulterated in content. (Section 33-EE of the Drugs Act) Any company proposing to manufacture ayurvedic drugs must take adequate precautions at the time of manufacture to prevent the drug from being categorized as poisonous under the ayurvedic systems of medicine. (Schedule E of the Drugs Rules) Chinese herb drugs face same problemsLack of global acceptance is not unique to traditional Indian medicines only. The traditional Chinese systems of medicines based on a variety of herbal formulations too are in the boat similar to ayurveda. According to media reports, the Chinese government and companies too have started to apply modern production techniques to get US regulatory approvals. Some 40 clinical drug trials of herb-based preparations are reportedly underway in China, Hong Kong and Taiwan currently. Huangqi is one such drug undergoing trials on human volunteers in local hospitals. This yellow-rooted plant is believed to control swelling and promote skinregeneration. Tests on rats had been completed. Dietary supplemnts such as Bak Foong pills, whose ingredients include deer antlers and ginseng, are other famous products now under modern trials. Bak Foong pills are popular among middle-aged and menopausal Chinese women who believe these enhance the immune system, improves digestion, regulates ovarian hormones and reduces the risk of heart problems. Chinese herbal medicines, like India's, don't have quality data to gain acceptance regulatory authorities. Most of the benefits are based on anecdotal evidence word of mouth publicity. Systematic scientific efforts to validate the properties were rare in both countries. For global acceptance more needs to be done. Apart from scientific validation, the production plants have to get the globally accepted certification called good manufacturing practice (GMP). This certification will conform to manufactured conditions that are clean and free of contaminants. In 2000, the Federal Drug Administration of the US (FDA) stopped imports of the Chinese herb family Aristolochia after reports of kidney failure among users in Britain and Belgium. ]]> <![CDATA[US Biotech industry - A snap shot]]> https://biospectrumindia.com/news/95/2599/us-biotech-industry-a-snap-shot.html https://biospectrumindia.com/news/95/2599/us-biotech-industry-a-snap-shot.html Tue, 15 Apr 2003 16:53:00 +0530 There were about 1,457 biotech companies in the US in 2001, representing a growth of 20 percent since 1992. The size of the US biotechnology industry has more than tripled since 1992.   The gross market capitalization has witnessed a 36 percent fall from the year 2000 to 2002   A survey by Business Week says, five of the top ten firms in terms of R&D expenditure per employee are biotech companies ]]> <![CDATA["It motivates me to work more "]]> https://biospectrumindia.com/news/95/1523/it-motivates-me-to-work-more-.html https://biospectrumindia.com/news/95/1523/it-motivates-me-to-work-more-.html Tue, 15 Apr 2003 16:52:00 +0530 BioSpectrum met Prof. G Padman    abhan, Honarary Professor, Indian Institute of Science and an Emeritus Scientist soon after he was chosen as the winner of the institution's first distinguished Biotechnologist Award. I am excited when the premier research center, Indian Institute of Science, announced my name for the first Distinguished Biotechnologist award. Not because I got the award but it has motivated me to work for five more years. This March I completed 65. Definitely the award has helped me to continue my research activities which I always love to do. My areas of interests are in developing new drug targets for malaria and alternative molecular strategies. As malaria is a poor man's disease, we hardly find investments from the private sector and multinationals. Only we can get funds from the government. For drug discovery the firms have to spend around $500 million and they have to wait for nearly 10-12 years to complete all the formalities for commercialization and to recover the costs. I feel this won't do for the pharmaceutical companies. Besides developing new drugs, I am working on how to make the new drugs viable/cheaper for the commoner. For tuberculosis we have drugs in the market. From them we found out that three drugs also work as anti-malarial drugs. A combination of three anti-tuberculosis drugs was used for our trails on mice. The results are 100 percent positive. We are now working on the next phase of clinical trials. Discussions are on with pharmaceutical companies. We have to wait and watch. I am also supporting my colleague Dr. PN Rangarajan, who has developed a DNA vaccine for rabies. For a developing country like India, DNA vaccines are very relevant.In addition to research, I am in the scientific advisory board of many firms like X Cyton Diagnostics, Bhat Biotech and Dabur Research Foundation. My role as chairman in BRPC an apex body at the department of biotechnology, will always keeps me busy. as told to Narayan Kulkarni Strand appoints Todd as senior VP Strand Genomics Pvt Ltd, Bangalore, appointed Todd Laird as the senior vice president of business development. He has 20 years of experience in international sales and business development spanning the life science, software, and high-technology manufacturing industries. Todd will be operating from Strand's new branch in the USA in Redwood City, California. Earlier Todd was VP of business development at GeneticXchange, where he was responsible for developing OEM and channel relationships with instrumentation, application software, and system integration partners. Paresh Verma quits Proagro BioSpectrum learns that Proagro's director (research) Paresh Verma has quit. The uncertainty over the government clearnace to the company's GM mustard seed has apparently prompted the move. He is learnt to have joined another Delhi based bioagriculture firm. Ketan to head Intel India operations Ketan R Sampat, has been appointed president, Intel India based in Bangalore. Intel Corporation has announced the expansion of Intel's management team in India in recognition of the growing importance of the country as a global design and development center. Intel has been focusing on Life Sciences as a major growth area for its solutions. ]]> <![CDATA[IVCA-US Investor showcase]]> https://biospectrumindia.com/news/95/1819/ivca-us-investor-showcase.html https://biospectrumindia.com/news/95/1819/ivca-us-investor-showcase.html Tue, 15 Apr 2003 16:34:00 +0530 The US chapter of IVCA (International Visual Communication Association) will organize an event to highlight the best technology & life sciences start-ups from India. The event is being organized on 13 May 2003 in California. IVCA-US Investor showcase, the first Indian Company Investor Forum, which will showcase to Silicon Valley venture capitalists, the best India-centric technology and life science companies today. Attendees to this event will comprise top-tier US venture capitalists, angel investors, and service providers. 20 entrepreneurial companies from India will be shortlisted to showcase to a panel of VC's in Silicon Valley on Tuesday, May 13th, 2003,Sheraton Hotel, Palo Alto, California. The companies will benefit from participation in this event in a number of ways including potential investments from US venture capital firms, validation of business plans, and exposure to potential business partners, say the organizers. All the members have to nominate their portfolio companies or other recommended entrepreneurial companies to take part and send their business plan, executive summary along with the attached application form duly filled latest by 15 March 2003. Beyond 15th, the organizers will not entertain any forms. Each selected company will be invited to be present at the Investor Forum Event in the following manner: 15-minute presentation followed by a five minute question and answer session Distribution of executive summaries and / additional information to the audience Exhibit presentation materials and /or products for display in assigned location There will be an opportunity to network with venture capitalists and fellow entrepreneurs at lunch following the presentations Please send in your forms to info@ivca.org. For more details please contact Sumeet Singh at 0120 2530106 / 98105 04995. Seed treatment conference The ISF Treatment and Environment Committee (STEC) is organizing a Seed Treatment Conference in Bangalore. It will be held at the Leela Palace Hotel in Bangalore, just after the annual ISF Congress, on June 12-13, 2003. The objective of the conference is to update the participants on the recent evolution of technical, regulatory and practical aspects of seed treatments. The ISF STEC is composed of representatives from the seed industry, the crop protection industry and the seed treatment industry. This gives a guarantee of the balanced and comprehensive approach of the issue. For more details, contact: Dr Manmohan Attavar Chairman World Seed Congress-2003 India C/o Indo-American Hybrid Seeds (India) Pvt. Ltd. 17th Cross, 2nd 'A' Main, Banashankri 2nd Stage, Bangalore - 560070, India. Tel. : +91-80-6760111 Fax : +91-80-6761479 Email : isf2003.ho@indamseeds.com BIO 2003 Annual convention Biotechnology Industry Organization (BIO) is organizing the BIO 2003 Annual Convention. The world's largest gathering of biotechnology leaders comes to Washington, DC. More than 15,000 participants and over 500 journalists packed the Toronto Convention Center for BIO 2002. This year, for the tenth anniversary convention, the participation expected is between 15,000 and 20,000 biotechnology executives, politicians, scientists, and reporters to descend on the nation's capital. Date: June 22-25, Venue: Washington Convention Center, Washington, DC. For more details contact: BIO Meetings Department 1225 Eye Street, NW, Suite 400 Washington, DC 20005 Phone: 202.962.6655 Fax: 202.589.2545 Email: bio2003@bio.org Details logon to http://www.bio.org/ Conference on Clinical Research India stands at the threshold of global development with the potential to emerge as the new lexicon for R&D and clinical research & trials. On this context a "Conference on Clinical Research: Roap Map for India" will be held from 3-4, April, 2003 at hotel Hyatt Regency, New Delhi. It has been envisaged as an endeavor that will provide the necessary interface and capability in clinical research. The objective is to provide a platform where Indian and International industry, regulators, investigators, IRB members, and other agencies meet, interact, and network to put India on the global map of clinical research. The topics to be discussed in the conference are Evolution of clinical trials and its Impact on clinical practice Clinical Research and Regulatory Control Clinical research and skill base-gap analysis and challenges in the Indian context Ethics in clinical research GCP - QA System for the software of medicinal products Recommendations of working group for each session For more details, contact: Divya Chopra Confederation of Indian Industry 23, Institutional Area, Lodi Road, New Delhi 110 003 (India) Tel: +91-11-24629994-7, 24641074 Fax: +91-11-24626149 / 24633168 Email: divya.chopra@ciionline.org For more information and registration details, contact:  Confederation of Indian Industry at www.ciionline.org Pharma India 2003 The International exhibition and conference on pharmaceutical industry, fine chemicals and services- Pharma India 2003 will be held from 24-27, September 2003. The exhibiton will be organised by Hyderabad International Trade Exposition Center (HITEX) at Hyderabad. Pharma India 2003 showcases the rapidly progressing scenario of the pharmaceutical industry of India. Alongside Indian companies a large number of international companies will provide the global overview of this sector with new innovations and research techniques that are already on or in the anvil. The pharmaceutical industry in India is one of the largest and most advanced among the developing countries. The Indian pharma market has registered a growth rate of around 8.5% (2001). In terms of volume the Indian pharma industry has contributed around 8% of the total global production (2001). The Indian pharmaceutical industry is highly fragmented, but has grown rapidly due to the friendly patent regime and low cost manufacturing structure. Intense competition, high volumes and low prices characterize the Indian domestic market. Biotech India International 2003 The International Exhibition and Conference on Biotechnology Equipment and Services organized by HITEX will be held from 24-27 September 2003 concurrently with Pharma India 2003. nterkama India CIDEX will be putting on the International Exhibition on Process and Manufacturing Automation , Integrated IT Solutions, Interkama India from the 24th to 27th September 2003. It will be held alongside with the Biotech India and Pharma India trade fairs on the new Hitex exhibition ground in Hyderabad. Email: info@cidex-tradefairs.com For more details, Contact: Japesh Thakur Project Manager CIDEX Trade Fairs Pvt. Ltd. Delhi Office 1, Commercial Complex, 2nd Floor, Pocket H & J, Sarita Vihar, New Delhi 110 044 Tel : +91 (0)11 6971056/66 Fax :+91 (0)11 6971746 Email: ThakurJ@cidex-tradefairs.com Mumbai Office 416, Raiker Chambers, Opp. Firex, Govandi, Mumbai-400 088 Tel: +91 (0)22-555 8352/550 9325 Fax:+91 (0)22-555 8353 Biotechnology, science & society at a crossroad National Agricultural Biotechnology Council (NABC 15)event, "Biotechnology, Science and Society at a Crossroad," will be held at The Westin Seattle in Seattle at Washington, from June 1-3, 2003. Topics to be discussed at NABC 15 include the Public perceptions of agricultural biotechnology Biotechnology and sustainable agriculture Biotechnology and international trade Impact of biotechnology on world agricultural production. NABC 15 is organized into half-day modules. A module consists of 10 minutes of introduction by the moderator followed by 2-3 talks by the invited speakers whose allotted time is 90 minutes. Modules are: science and society at a crossroad, sustainability, environmental and production issues, consumer issues and trade and biotechnology applications for agriculture in developing countries. For more details: Email: washi@westin.com. Asian pharmaceutical validation & compliance Asian Pharmaceutical Validation & Compliance summit on Strategies for ensuring compliance with regulatory requirements will be held from April 23 - 24, 2003. The venue is Grand Copthorne Waterfront, Singapore. The major players in Indian Pharma industry-Pfizer India, Ranbaxy Laboratories, Astrazeneca pharma India- are participating in this summit. For more details, contact: Email: enquire@iqpc.com.sg , Website: www.iqpc.com.sg/AS-580 Drug discovery technology 2003 Drug Discovery Technology 2003 will be held from March 30 - April 3, 2003 at Stuttgart, Germany. The event presents an unprecedented opportunity for companies in all fields of drug discovery to network with senior decision-makers all under one roof. Whether you are looking to forge new collaborations, find new investment opportunities, or meet existing clients Drug Discovery Technology- 2003, in Stuttgart is the place to do business. Contact Information: Michelle Bryant Mortimer House, 37-41 Mortimer Street, London W1T 3JH Tel: +44 (0) 207 017 5069, Fax: +44 (0) 207 453 5422 Email: michelle.bryant@informa.com ]]> <![CDATA["We have incubators for SMEs looking for opportunities in CRO"]]> https://biospectrumindia.com/news/95/1512/we-have-incubators-for-smes-looking-for-opportunities-in-cro.html https://biospectrumindia.com/news/95/1512/we-have-incubators-for-smes-looking-for-opportunities-in-cro.html Tue, 15 Apr 2003 16:29:00 +0530 How do you see the growth of biotechnology in Karnataka and in India? Biotechnology is the next sunrise industry with the whole world looking at it with great hope. It is the availability of quality manpower that fuels this sector and India has plenty of such manpower. Karnataka has been the fastest growing bio-cluster in the country. The presence of renowned life science research institutes like IISc, NCBS, JNCASR, UAS have added to the growth. The state has attracted one new biotech company every month for the past two years. What are your immediate programs / action plans to boost biotechnology in the state? The government of Karnataka has decided to establish a state of the art Biotech Park with Common Facilities Center and incubation facility for the biotech startups. The department is also looking at possibility of establishing a marine biotech park in Uttar Kannada district. Where do you see Karnataka in the biotech map of India in terms of revenue/market capitalization? As mentioned earlier Karnataka has been the fastest growing bio-cluster in the entire country. It has more than 65 percent of the core biotech companies in the country. The investments in this sector have quadrupled since 1999. The state has attracted over Rs 500 crore of investments and is generating revenues in excess of Rs 700 crore annually. Karnataka was the first state in India to have announced a BT policy. But today many states like Maharashtra, TN, AP, UP, MP, Delhi, Kerala, Chattisgarh, Gujarat etc. are showing keen interest in BT. Has Karnataka been able to capitalize on the early lead? What is Karnataka's unique selling proposition (USP)? It is the availability of research talent, cost effective trained English speaking manpower, and the presence of leading life science research institutes that have provided an edge over the other states. You were part of the CII biotech mission group to US, Canada and UK in June 2002. In Feb 2003 the agri-biotech delegation from Canada has visited Bangalore. What is the out come of these visits from both the sides in terms of joint ventures, flow of funds? Exchange of visits has resulted in several US based companies to have strategic alliances with Bangalore based biotech companies and many more are looking at setting up their shop in Bangalore. With no proper syllabus, more institutes and colleges are offering courses in biotechnology at the cost of students. How will the government tackle the mushrooming problem of biotech departments/ institutes in the state? The department of IT and BT has established BITES, the Board for IT Education Standards in engineering colleges. Similarly, we will shortly have Karantaka Biotechnology Developmental Council (KBDC), which shall look into the fly by night operators. The department has initiated formation of a committee with educationists, vice chancellors and other officials to upgrade the biotech syllabi regularly. Although a BT park was announced as a part of the state's BT policy in 2001, why has there been a delay in setting up a BT park near Electronic City in 75 acres of land? Though several sites were suggested for the Biotech Park it certainly takes time for having an ideal site. The Vision Group on Biotechnology has opined that the Electronic City phase III site is best suited for the proposed Biotech Park. The companies in Biotechnology are looking at the government/venture funding. In such a scenario, why is the government holding back the creation of the corpus fund of Rs 50 crore which it had announced during the last budget? The government has already announced the creation of "The Biotech Fund" in the millennium biotech policy with suitable contribution from the biotech industry. This fund shall certainly be very useful for small and medium scale biotech startups. Do you have any programs for the small and medium entrepreneurs who are interested to take up contract research projects? We have already established incubators in the Institute of Bioinformatics and Applied Biotechnology for small and medium scale companies that are looking out for opportunities in the contract research sector. It is important to mention that the Common Facilities Center in the proposed Biotech Park will have full-fledged incubators to handle many areas d biotechnology in the proposed Biotech Park. ]]> <![CDATA[Bangalore Bio 2003 - platform for B2B opportunities]]> https://biospectrumindia.com/news/95/6594/bangalore-bio-2003-platform-for-b2b-opportunities.html https://biospectrumindia.com/news/95/6594/bangalore-bio-2003-platform-for-b2b-opportunities.html Tue, 15 Apr 2003 16:27:00 +0530 Come April, and the focus will be on Bangalore, the biotech capital of India. During 15-17 April, the city will witness the congregation of experts from India and overseas to discuss, debate, showcase, and converge on the developments in biotechnology. The city is host to the premier and mega biotech event in Asiaâ€”Bangalore Bio. This event, promoted by the government of Karnataka and Vision Group on Biotechnology, is the third in the series so far. It may be recalled that this regular event was started in 2001 immediately after the announcement of the Millennium Biotech Policy by the state government. The event caught on with understanding of the changes taking place in biotech industry in different corners of the world. In its second effort, the event became more popular. It had representations from 12 countries and participants from 72 companies. This year too the organizers have made all arrangements to make the event more meaningful and successful. Here is a premier on what to expect. The Knowledge Condominium To make the event industry-friendly, apart from the regular features, Bangalore Bio 2003 has special events like Knowledge Pavilion, CEO Conclave, Awards Nite, and Bio Banquet. Special emphasis would be on promoting the knowledge base. Explaining the motif behind the event, Vivek Kulkarni, secretary, IT and Biotechnology, government of Karnataka, says, "Knowledge Pavilion, one of the new features and being planned at the tradeshow, would showcase premier research labs of India and also the top educational institutes. This is primarily conceived to push forward the case of India as the largest, scientifically trained English-speaking pool of knowledge workers. It will pave the way for the organizations and institutions to discover new opportunities of partnership with the Indian market." The highlight will definitely be the participation of eminent scientists like Dr RA Mashelkar, director general, CSIR, Prof. Vijay Raghavan, director, NCBS, and Prof. Manju Bansal, director, IBAB, besides scientists and experts from different departments of Indian Institute of Science and industry in the knowledge pavilion. The CEO Conclave is aimed as an interactive session for over 300 top-level executives from the industry. While the Awards Nite program would be an acknowledgement forum for the best efforts in the event in the form of awards for best stall design, creative display of products, and services among things, Bio Banquet would be the grand finale of the Bangalore Bio 2003. It will bring the curtains down to the third edition of Bangalore Bio. The organizers will place the highlights and outcomes of the event in terms of MoU's signed and investments committed during the three day meet. The fourth Bangalore Bio will also be launched at this special event. This also provides an opportunity for the overseas participants to receive the first invitations to register for the next year's event-taking place on 15-17 April. The Business Exchange The organizers have set up three platforms - investor, technology, and collaborations â€” at B2B forum for the convenience of the trade delegates to close the deals. The structured opportunities will provide the corporate, who wish to finalize collaborations, technology transfer, marketing and trade, investment deals. Considering that every month, one biotech company sets up shop in Bangalore, Bio Investor 2003 will serve as platform for providing opportunities for investors looking for attractive investment opportunities among the presentations made at this forum. The Technology Transfer 2003 enable will technologists from India and abroad to present a preview of their latest technologies, and also take a look at other noteworthy technologies showcased. This is one of the hottest areas going about, namely, the scope for innovative technologies in the vast, and emerging market of India in areas such as agri-biotech, bioinformatics and others. The Collaboration 2003 would provide the right occasion for those keen on collaborative associations of various kinds â€” CROs wanting to provide back-end services to MNCs, manpower sharing. The Think Tank Apart from business deals, Bangalore Bio will provide an opportunity to expand the horizon of biotech knowledge. The conference will be the virtual think talk of new ideas for profitable growth in today's hyper competitive biotechnology, pharmaceuticals, and healthcare markets. The technical sessions ranging from platform technologies to informatics and IPR to clinical development and drug discovery and development provides delegates the opportunity to interact with speakers and analysts. Experts from USA, Israel, Singapore, France, Germany, India will speak on topics from stem cell research to clinical research and trials, managing IP in new age to product development from lab to consumer, GM crops, biotechnology in India etc. The concurrent three-day conference of Bangalore Bio 2003 at the sylvan surroundings of Indian Institute of Science will feature over 50 international speakers deliberating on a variety of topics. Some of the speakers expected at the conference include Marcel Rosencweiz, GPC-Biotec, Germany, Geoffery Dunbar, USA, Dr Raefelle Palminteri, Wyeth, UK, Dr John Kolthammer, Dr Stelios Papoundolous, Dr Chetan Khosla, Dr Martine Clozel, Switzerland, Gladys Mirandah, Singapore. Vivek Kulkarni said that early preparations have helped to get expert speakers to lead the conference sessions. This has made it possible for the delegates to plan their schedules well in advance. Participant's Paradise The last year's success and recognition has pulled in more state and country participation to the trade show. It will unfurl the chance for the companies and their associates to meet at one place. The show has been categorized into bio-countries, bio-states, bio-instrumentation, bioprocessing, VCs and investment pavilion. The certificate from the US Commercial Services, the endorsement from the Trade Commission of Denmark and Republique Francaise and approval by the India Trade Promotion Organization (ITPO) have provided support to the government of Karnataka and Vision Group in selling the event. And also helped in attracting more delegates, exhibitors and participants to this event. Vivek Kulkarni said that six states, 22 countries, 150 exhibitors have confirmed their participation. "We are expecting about 200 delegates and nine country delegations, 25,000 trade visitors and 30,000 public visitors which is more than last year's participation and visits," he added. The countries from which biotech companies have since confirmed attending Bangalore Bio 2003 include France, Denmark, Sweden, Switzerland, Spain, Norway, Germany, Singapore, Malaysia, USA, Canada, Australia, Netherlands, Belgium, Japan, Uruguay, Ireland and South Korea, UK, China, Hungary, New Zealand. Vivek Kulkarni maintained that recognizing the opportunity, Andhra Pradesh, Gujarat, Maharashtra, Rajasthan, Orissa, Chandigarh and Tamil Nadu have confirmed participation at the tradeshow. Kerala, Chattisgarh at Punjab are likely to confirm.With the road laid out for a perfect zone, Bangalore Bio 2003 is all set to be India's best platform to showcase its rapid growth in biotechnology to the world. Narayan Kulkarni ]]> <![CDATA[A yacht with Technology hull]]> https://biospectrumindia.com/news/95/1906/a-yacht-with-technology-hull.html https://biospectrumindia.com/news/95/1906/a-yacht-with-technology-hull.html Tue, 15 Apr 2003 15:44:00 +0530 Avesthagen had a very humble beginning in 1998. Four employees, Dr. Villoo Morawala-Patell's brain, hard work and a bungalow in Sahakarnagar, Bangalore. Villoo and friends with some seed funding totaling nearly $300,000 (Rs 1.5 crore). Now in the fifth year, Avethagen is heralding the revolution in the staid Indian life sciences industry. While traveling around the world Dr Villoo Morawal-Patell realized that what India needed was a powerhouse of technology in the life sciences to become a world leader. Blessed with a bountiful biodiversity and surplus skilled manpower, what we needed was a technology platform to utilize these resources. To make this a reality, Avesthagen was born to produce drought and pest resistant rice. Avesthagen has come a long way since then adding more pathways in informatics, proteomics, neutraceuticals and genomics. Claimed to be the first genomic company in the country, Avesthagen has been rated amongst the top five life sciences companies for its business plan presented at the TiEcon, 2002 (the world's largest conference on entrepreneurship) held at Westin, Santa Clara, California in the heart of the Silicon Valley. Avesthagen is a fully integrated bioinformatics company set up for promoting research and development in various fields of biotechnology. Avesthagen aims to improve the productivity in agriculture and develop agro-technologies that would lead to value addition in food and pharma products. Etymologically the word Avesthagen is derived from the Persian religious system of 'Zoroastrianism', which was founded by Prophet Zarathustra. Agriculture is given a pride of place by Zoroastrians and "Avestha" stands for knowledge. Thus the name Avestha Gengraine Technologies is symbolic of the company's application of knowledge in the areas of agricultural biotechnology and medicinal plant based drug discovery Founded in April 1998, Avesthagen became a full-fledged company in 2000 with the restless efforts of its CEO Dr Villoo Morawala-Patell, one of India's most prolific and academically accomplished biotechnologists. The commercial ramp-up happened in the last three years with the company filing about 40 patent applications in this field. Through these new initiatives, the company plans to achieve $2.6 million ( Rs 11 crore)of revenues in the first year and in five years, $5.2 million( Rs 26 crore) through the sale of skincare and diabetes products. Avesthagen is developing a variety of drought tolerant GM rice which is currently undergoing field tests. The product should be in the market in four years. Avesthagen has decided to go in for an initial public offering (IPO), after repeatedly facing the not-so-understanding faces of venture capitalists. The company has also entered into a strategic tie-up with International Crop Research Institute for Semi Arid Tropics (ICRISAT) to provide supportive services in genomics. To scale up global operations, the company is looking at additional funding and has appointed Kotak Mahindra and KPMG as global advisors for raising about $10 million ( Rs 50 crore) Collaborations with universities, research institutions and corporations around the world, it is actively expanding its portfolio further. The technology that was used initially was developed in NCBS-TIFR (National Center for Biological sciences- Tata Institute of fundamental Research) labs through funding from the Rockefeller foundation. Exactly after one year, Avesthagen has signed an MOU with the University of Agricultural Sciences (UAS), Bangalore, and some projects were initiated there. Avesthagen raised $ 2 million (Rs 10 crore) as venture funding from ICICI ventures, Global Trust Bank and TATA Industries Ltd. Operating from the state-of-art-facilities in the International Technology Park, near Bangalore, Avesthagen has specific capability in laboratory information management systems, marker-aided selection, DNA micro-arrays, proteomics, GMO testing, high-throughput screening, gene mapping, gene discovery and plant transformation. Avesthagen is also looking at setting up business development offices abroad to scan the commercial opportunities in the segments where it operates. Opportunities in seed development, contract manufacturing for pharma majors and biotech are huge, and the company is looking at an entry into the US, European and Australian markets. Avesthagen has offices in Kuala Lumpur which provide on-the-ground office support. Avesthagen has also entered into a research-based alliance with AstraZeneca in the drug discovery program for tuberculosis. The biotech company also has a strategic tie-up with the Hyderabad-based ICRISAT (International Crop Research Institute of the Semi Arid Tropics) to provide supportive work in the genomics. The project with ICRISAT is aimed at developing improved crop varieties and will translate into definite intellectual property rights (IPRs) for both the parties Biotechnology based agriculture is another area where Avesthagen has found its own space. As India has its own set of agricultural problems, be it climate or pests or diseases, Value added crops, pest and disease resistant varieties with specific reference to India will definitely have a place on the shelf in India. Biotech needs an assessment of the relevant factors before it is taken up recently Avesthagen did a study on the economic importance of drought resistant rice for Karnataka in collaboration with GREQAM â€” Groupe De Recherche en Economie Quantitative de Aix - Marseille under the University of Aix -Marseille. Expanding, changing premises, adopting new protocols, updating knowledge are all part of the joy and laughter tears and pain at Avesthagen. Avesthagen is constantly growing to keep up with the most current breakthroughs in the world. The interim phase was tough but they survived it and the international network has won the day. Roby Ajith "I am fortunate in my team with an intimate involvement"In a recent write up, an Indian magazine asked: why Basmati rice has a unique aroma? It then answered grandly: Because Dr. Villoo Morawala- Patell did the RNA reading of that rice genome. The magazine may have exaggerated a bit. But that is the way a section of the society looks at her with awe. A prominent speaker at biotechnology meetings, people hear her with rapt attention as she narrates the struggles, the fears, and the successes that make life as an indomitable entrepreneur. Dr. Villoo Morawala- Patell shared her experiences and expectations with Roby Ajith of BioSpectrum. Villo with her daughters Background: Dr Villoo Morawala Patell, is a plant molecular biologist from the University of Louis Pasteur, France. She studied at different boarding schools such as St Annes school, St Francis School, Secundrabad and Sophia College, Mumbai. Then did her Ph.D. at Louis Pasteur, Strasbourg and completed the post doctoral work at the University of Ghent. With her research group, she holds several patent applications in gene discovery and functionality, gene transformation for rice and millet as well as tissue-culture techniques, bioinformatics, and gene-sequencing techniques. Clearly, the startup is allowing this highly qualified Indian scientist to venture into the world of business. Biggest exposure: We have the Research Process outsourcing (RPO) model and many products in the pipeline on the convergence of food and pharma. The main research in Avesthagen revolves around the seed for food and food for medicine, medicinal plants, and quality food and quality traits at the IP level. We generate our IP and license our products. We've developed cytoplasmic male sterily in rice. This would be useful for rice breeders. How She handled the pressure: Pressures are always there. But over time, I have developed the ability to switch off from one problem and attending to another, maintaining the essential linkages and connectivity. Perseverance pays off: Yes, I have paid off my early debts on a milestone basis. The existence of a company depends upon its current business plan. If you have a discovery-services company such as ours where a large amount of the money is going into research then you would require 2-3 years to break even. And we are not so concerned at short-term measures  as our play is really for the big ticket at the end of 4-5 years. Sacrifice and battles: Lots of sacrifice and battles I have gone through in my life. I have traveled a long way to reach what am I now. It would be hard to describe it all. Family time is one that pinches most. My daughters Sarah and Sanaya are suddenly very big. Lessons learned from the experience: Finally one stands alone although everybody (employees, investors, suppliersâ€¦) contributes, Survivors' perspective: I am fortunate in my team with an intimate involvement. It is an emotional involvement. Desires: To see Avesthagen stand up to the world as an India based global company. Grow it through strategic alliances and co-development. Looking back: Proud, we did it absolutely honestly. Can do it, bigger pride. Strengths: A lot's been said about the potential in biotech. There is enormous potential but the hype that anyone can stand up and start a serious biotech company is wrong. You need enormous knowledge of both the industry and the science and have a serious vision to be successful. You also need enormous grit, determination broad shoulders and a strong heart to survive the first three years. There are no short cuts in this business and no early lucre. Hobbies: Swimming, reading, update of the political world Staff motivation: Opportunities to travel, attend conferences, I share everything with my employees. Avesthagen has a staff of 40, many of them sourced from the bioinformatics faculty of the Madurai Kamraj University, the only one of its kind in India. In keeping with its credo of convergence, the company is appropriately headquartered with the IT elite in the sparkling first-world environs of Bangalore's tech park in Whitefield. ''We are not only doing pure research, but also carrying out contract research Force behind your success: I believe in the elements and forces of nature, energy, fire. My mother in law was the first Indian woman Ph.D. in physical chemistry from Imperial College, London. She was very encouraging. Participating husband. Children, they always looked up to me. Parents gave me the grit to persevere. Which place does she belong to: Born in Navsari at Gujarat. But likes to represent India, Karnataka, Andhra Pradesh and Gujarat. History of Avesthagen in your perception: I started as a garage entrepreneur, very small, four students and big ambitions and today we are what we are. But what I believe we should aim for is new discovery, something not found before that could contribute on a global scale and put us on the map as inventors. Future of biotechnology: In the next three years or so with the new generation of entrepreneurs, biotechnology will be a serious affair with more than 100 biotech companies in the pure biotech sense, (not ancilliary to pharma/crop) will mushroom. Indian biotech will develop very rapidly and there would be the entry of international companies. Funding for Avesthagen: We are raising a second round of VC funding from international investors and expect that this will materialize in approximately 3-6 months. Funding requirements of biotech industry: Yes, funding is a problem. And some of the reasons are new faces, no history to attract banks into lending, Knowledge-based entrepreneurs with no collateral power for banks to fund. Government loans take a long time to process and also require collaterals. VCs need to study the international scenario better, do a thorough homework and should not rely on the entrepreneur to do the convincing. This will save time and energy. Role of Indian biotechnology in the global market: India will, in phase 1, outsource work from the West. In phase 2, start manufacturing. Everybody recognizes the potential but it will need a greater effort from all concerned to really make it big. Tomorrow is another day. Family: Parents are very simple people, believe in simple living and high thinking. Husband was always participating and children involved. Mother's family was land owners/farmers. Father is an academic from Surat. Lived in the district of Hydrabad on the invitation of the Nizam. Brother is a writer and has written three books on cricket, sister accountant at ADNOC. My husband Zareer Patell is an icon on physical fitness. And jazz pianist. ]]> <![CDATA[Dr Swati Piramal - Quest, A way of Life]]> https://biospectrumindia.com/news/95/7036/dr-swati-piramal-quest-a-way-of-life.html https://biospectrumindia.com/news/95/7036/dr-swati-piramal-quest-a-way-of-life.html Tue, 15 Apr 2003 15:19:00 +0530 "All men seek one goal: success or happiness. The only way to achieve true success is to express yourself completely in service to society. First, have a definite, clear, practical idealâ€”a goal, an objective. Second, have the necessary means to achieve your endsâ€”wisdom, money, material and methods. Third, adjust all your means to that end," -Aristotle If, this is a mantra of success, the life and career of Dr Swati Piramal would tell why she is successful. She did not want to do the obvious. So she did not pursue "just" a medical career. She braced medicine with research. A doctor from University of Bombay, she joined Harvard School of Public Health, Boston, to learn and understand the happenings in pharmaceutical and biotechnology industries. Passion drives her. She is passionate about research activities taking place in herbal, clinical discovery and nutrition research in pharmaceuticals. Passionate about providing easy access and low-cost healthcare to the under privileged children. Her specific research interest areas include malaria, tuberculosis, AIDS, and diabetes. Knowledge, passion, and compassion have taken her to where she is today. She heads one of the country's leading pharmaceutical company, Nicholas Piramal India Ltd, as director - strategic alliance and communications. Her responsibilities include R&D, information technology, medical services and knowledge management for the healthcare group of Piramal Enterprises. Initial achievements "In the first half of 1980's, that is, during my early professional days, Parel, where we have our company headquarters, had over 25,000 cases of polio. Looking at the gravity I initiated awareness campaigns in 1982 by organizing plays, skits etc. The campaigns have yielded results over the years. And in 1990, the 'city of mills" was declared as "no-polio zone". I was amazed with the results. As a reward to the women of the city, I distributed one-meter cloth to all to prepare dresses for their children. I was thrilled to see the kids in colorful attires laying at the city" recollects Dr Piramal. This tech savvy doctor, heading the task force for rapid implementation of information and technology research strategy at Nicholas Piramal, succeeded in ensuring that all manufacturing sites were ready on Y2K and were ERP enabled. Under her leadership, a vast wide area network using VSAT technology was put in place. She has set up 12 cyber cafes in the country for training and knowledge management of medical field representatives and doctors, started the data-warehousing solutions to manage large data bytes of information in the healthcare industry, and started a new project to implement web enabled e-business solutions. About her initiatives in implementation of IT strategy she said, "my core belief in science and technology helped me set up cyber cafes in 1992, when few had heard about it. The objective was to help the medical representatives and doctors. We have over 250 products in our list in different categories. The cyber cafes helped us to interact with field representatives and doctors about our products. And to support them to take proper decisions at the right time. This is purely for interaction." Looking ahead Under her leadership, Piramal Enterprises has made significant progress in discovery research, chemical process development and biotechnology. Clinical research for planning clinical trials, new drug protocols and pharmacokinetics labs, herbal research for DNA fingerprinting and standardization of ayurveda, the setting up of a business driven R & D program in the company (BDRD) and contract research and technology partnerships with some of the leading companies in the world are her latest achievements. Biotech initiatives "We have a Biotek division. It markets life saving and critical care products of F. Hoffmann-La Roche, Switzerland and NeXstar Pharmaceuticals Inc., USA. It all started in 1994, when two products â€” Neupogen and Roferon-A â€”were launched to enter the biotechnology field. After operating under Piramal Healthcare Limited for about two years, in January 1997, we hived off the Biotek division into a separate strategic business unit primarily to focus on its key brands, improve marketing and services of high tech products and better visibility in the market place. The core purpose of the division is to improve patients' well being by making available to the doctors latest therapies with the launch of original research molecules. Since its inception, the division has launched 12 new products. On an average that's a new product every five months. A remarkable success rate in this complex and critical field covering many areas of human medicine including oncology, virology and nephrology," she said. She added that Roche and NeXstar being the forerunners of biotechnology, the Biotek division is set to launch several new products and is poised for a quantum leap in near future. Foray into biopharma Dr Piramal was part of the management team at Piramal Enterprises that acquired the Hoechst Marion Roussel Research Centre in Bombay and set up the new Quest Institute of LifeSciences and the Wellspring Clinical Facility in Mumbai. "The acquisitions played a catalytic role for our success. We never looked back after we acquired Nicholas Laboratories from the UK-based Aspro Nicholas group in 1988. It has also supported us to move up the ladder by pushing down the competitors, said Dr Piramal. Acquisition of Rhone-Poulenc India has catapulted the organization to the second position with a market share of about five per cent. The number of Piramal brands in the ORG-MARG of Top 300 pharma brands jumped to 16, putting it just behind Glaxo-SmithKline with 21 products. Prior to the acquisition, the company shared the second rank with Cipla and Ranbaxy with 12 products. "The focus of our basic research is the development of New Chemical Entities (NCE) in select therapeutic areas. In addition to this oncology compound, development is underway for five NCE compounds - cardiovascular (2), diabetes (1) and anti-fungal (1) and cancer (1). We have already filed our first patent for a NCE â€” an anti-cancer molecule NP102. The new molecule is a cyclin-dependent kinase 4 (CDK4) inhibitor. We are nearing the completion of the first phase of the 12-year project. Each project cost is estimated at Rs 12 crore ", said Dr Piramal "Being the director, I will do my homework properly to take the organization to the forefront of the industry. I do read a lot to learn and understand different emerging fields. Graduation with master's degree from Boston helped me to understand areas like biotechnology, pharmaceuticals, and law as well. This has pushed me to initiate steps to implement the IT, KM and medical services in the organization. It is all because of the support from my family members - parents, children, husband, in-laws." Despite the hectic professional life, she spares enough quality time for her daughter who works with the leading management consultancy McKinsey in Mumbai and the son who is still in college. Recognition Recognizing her specialization, the government of India has appointed Dr Piramal as a member of a special committee set up to transform India into a knowledge power. She has been the vice-chairperson of the Biotechnology Advisory Board set up by the Department of Biotechnology. Considering her active role in the progress and development of biotechnology in Maharashtra, she has been asked to lead the Maharashtra's Maha BioYatra, "Bio Wednesday forum", a joint venture of Confederation of Indian Industry and government of Maharashtra. She received the ChemTech -Cew 2003 (biotech industry) achiever of year Award. Happy about receiving the award, she said, "the recognition has encouraged me to take up more initiatives so that benefits of science and technology could reach the poor people. " Proud to be an integral part of Mumbai, Dr Piramal said, "I want to do something for the nation. I am planning to take up a project that could change the life of the rural folk in Rajasthan. The project is already under the drawing board. " Areas of interest She has co-authored a book on nutrition and health along with Tarla Dalal titled "Eat Your Way to Good Health." Another book titled Diet & Nutrition Guide for Patients with Renal Disease and Related Disorders was co-authored with Dr Vidya N. Acharya. She has published articles in many leading publications. Apart from writing books Dr Piramal said, "I love cooking, reading, writing sprits for television, photography and poetry. At present I am studying folk poetry, particularly the works of Gurudev Rabindranath Tagore. " Narayan Kulkarni"Besides a strong biotech policy, Maharashtra's Maha BioYatra is a major move"In a conversation with Narayan Kulkarni of BioSpectrum, Dr Swati Piramal explained the biotech opportunities in Maharashtra, the state government initiatives, and the reasons for lack of funding to the biotech industry and its growth in India. What are the initiatives to push up biotech industry in Maharashtra? Besides a strong and clear biotech policy, Maharashtra's Maha BioYatra is a major move. Under this program the state government along with Confederation of Indian Industry has launched BioWednesday network forum. The forum provides a platform for the industry people to discuss issues ranging from funding to marketing in the fields of life sciences, genomics, medicine, bioinformatics, agribiotech, marine biotechnology and understanding to patenting. During this monthly meet, we invite experts on varied subjects. And we discuss a lot of other industry-related issues. Apart from this we in Maharashtra observe 14 November, the birth anniversary of Jawaharlal Nehru, as the Biotechnology Day. The purpose of observing the day is to carry the message that biotechnology can be a key life care tool of the twenty first century to the public at large by improving food, health, environment etc in a major way. How is Maha BioYatra helping the industry? Maha BioYatra - a network forum is acting as a communications and marketing network for Maharashtra's bioscience community. It enables corporate, researchers and scientists to exchange ideas, share opportunities and develop potential business partnerships and learn from each other. As the forum addresses issues like how we can build trust amongst users and consumers, what road map can we use to surge forward, what are the policies that are needed to encourage this sector, how we can apply biotechnology to improve food grain output, People involved in different walks of the society like VCs, policy makers, doctors, experts and scientists, financial institutions, consulting companies will benefit.. At one of the regular meetings of BioWednesday network forum, a company with many products in its basket approached me for assistance. The company has come out with industrial enzymes. As my organization is not into commercialization of the industrial enzymes, I discussed the matter with other members and suggested whom to contact. This has solved the problem. Why venture funding is not taking place in biotech in a big way? People are not convinced about the viability of projects, the quality of the clinical trials in India and the regulatory standards. I think the problems will vanish when we have a few success stories and we have a few things that have beaten the world, or are being sold in the world markets. A drug, which is produced in India and has a global market would be a dream for any VC. They will come running then. I think it is just a matter of time. Narayan Kulkarni ]]> <![CDATA[Environ protecting Enviroseb]]> https://biospectrumindia.com/news/95/3363/environ-protecting-enviroseb.html https://biospectrumindia.com/news/95/3363/environ-protecting-enviroseb.html Tue, 15 Apr 2003 14:58:00 +0530 Advanced Biochemicals Ltd., a Nasik based industrial enzymes manufacturer has brought out a range of products for complete environmental protection through waste management. Each product is a balanced blend of active microbes and enzymes best suited for specific applications. These products are put out after extensive research and repeated field trials. Enviroseb finds applications in effluent, sewage, organic waste, and garbage treatment. This can convert agricultural waste as well as animal waste into quality organic fertilizer. Enviroseb has found useful in healthcare and sanitation for cattle, poultry and aqua farms. It enhances the growth of beneficial microorganism like azotobacter, rhizobium and acetobacter in soil and suppresses bacteria like ecoli and other coliforms. Enviroseb range of products include Eniroseb S, E and Enviroseb A1 to A3 BioAccess and scanner from BioEnable BioEnable, a technology company that develops intelligent positive identification products based on biometrics fingerprint recognition and wireless communication technologies, is ringing out BioScanner and access. The company offers cutting-edge security and convenience through this product. BioScanner is USB (Universal Serial Bus) PC peripherals, with a small optical fingerprint scanner. BioScanner comes with drivers and application software. BioScanner is a heavy duty commercial optical fingerprint scanner with high resolution, quality and long life. BioAccess is a compact, standalone, and fingerprint based access control terminal. It simply register users with one or more fingerprints and activate relay on successful verification. BioAccess is developed for access control applications like electromagnetic door locks, car locks, safes, industrial automation and security systems. BioAcess can store upto 140 fingerprints making it suitable for home, office and other access control applications. SysArris with new Oligo software OligoSys, a software product from SysArris software Pvt. Ltd., applies cutting edge algorithms to retrieve, process and analyze genomic data. OligoSys uploads template sequences from Microsoft Excel and Text files to design oligos. It analyzes and processes single as well as multiple sequences (batch processing). The option to manually enter a sequence and design oligos is also featured in OligoSys. Based on powerful algorithms, it suggests the best oligos for the input sequence and calculates its properties. OligoSys is a tool for the design of oligonucleotides for hybridization reactions, TaqMan, LightCycler, Molecular Beacon etc. Oligonucleotides are used for a wide variety of molecular biology applications and have revolutionized the field of biotechnology very much. OligoSys accepts templates from file or manually pasted sequences to design oligos. Based on powerful algorithms, it scans the complete gene sequence or selected regions to obtain stringent and specific oligos and their properties. Natrotene - Natural Mixed Carotenoids containing predominantly betacarotene from the algae, Dunaliella salina, has been manufactured by Proalgen Biotech Ltd., a Chennai based company. The company has successfully isolated a natural strain of algae Dunaliella Salina and has developed the process for mass culture of these algae to produce natural betacarotene for various applications. Betacarotene is a precursor of Vitamin A, a fat-soluble micronutrient essential for healthy vision, cell reproduction, immune function, wound healing, and other crucial body functions. The technology involves starting with fresh water for cultivation of algae and adding basic ingredients to make it to artificial seawater. When seawater is used, there are multitude of competing organisms that are likely to take up the media for growth. These can include at least 7 to 8 species of Dunaliella sp. itself, that do not produce betacarotene but grow well under the same conditions. The process technology envisages harvesting using flocculants while most existing commercial processes do so by centrifugation. The company is also developing a bio flocculant and is likely to put it to use shortly. This would in economic parlance mean that outlay on plant and machinery and running costs are lower in comparison to the existing processes/ projects. BioGit for adjunct therapy in treatment of diarrhoea BioGit- a product of Bharat Biotech International Ltd - is a lyophilized preparation of live cells of the probiotic yeast; Saccharomyces boulardii. It is recommended as an adjunct therapy in the management of the various indications like the treatment of diarrhoea of various etiologies that include traveler's diarrhoea, viral diarrhoea in children and antibiotic associated diarrhoea. It is also indicated for treatment of irritable bowel syndrome and prevention of diarrhoea during continuous enteral feeding in adults and for vaginal yeast infections. The benefits of BioGit include it's capability to survive the harsh acids of the stomach when taken with food. It inhibits the growth of pathogenic bacteria. It may decrease the production of toxic compounds produced in the intestinal tract. It produces vitamins and other nutritional factors that may be utilized by the host. It may help to alleviate flatulence. CYSTI Chex to detect antibodies in CSF The Bangalore-based X Cyton Diagnostics has developed indigenously an ELISA kit called CYSTI Chex for the detection of anti cysticeracal anti bodies in cerebro spinal fluid. The kit uses excretory -secretory proteins of cysticercus cellulosae as antigens, the metabolic product of live cysticerci maintained in vitro. These are the only antigens seen by the human immune system. It is a special tool for neurologists to distinguish to between neurotuberculosis and neurocysticercosis. It identifies single parenchymal, multiple parenchymal and single ventricular cysts. This detection kit is for neurocysticercosis, a disease prevalent in Latin America and China apart from India. It is a patented product of Astra Zeneca. ]]> <![CDATA[Crazy Patent]]> https://biospectrumindia.com/news/95/1558/crazy-patent.html https://biospectrumindia.com/news/95/1558/crazy-patent.html Sun, 13 Apr 2003 13:10:00 +0530 The patent has been granted to a method for inducing cats to exercise and it consists of directing a beam of invisible light produced by a hand-held laser apparatus onto the floor or wall or other opaque surface in the vicinity of the cat. Then move the laser so as to cause the bright pattern of light to move in an irregular way fascinating to cats and to any other animal with a chase instinct. Source: Swiss Jokes Vinegar 'pinpoints cancer' Vinegar can help to identify cervical cancer in women. Research carried out in South Africa has found that washing the cervix or neck of the womb with vinegar shows up potentially cancerous cells, reports the BBC World Service. An early trial has suggested the technique is as effective as a pap smear which is the more usual way of spotting the disease. Doctors believe their research could pave the way for developing countries to introduce a cheap and effective screening program for cervical cancer. Vinegar comprises 95 percent water and 5 percent acetic acid. When this solution is placed on the cervix, it turns potentially cancerous tissue white. This enables nurses to offer patients an immediate diagnosis by simply looking at the cervix. This compares with a pap smear which usually needs to be sent off to a laboratory for testing. Dr Lynn Denny, a gynaecologist at Groote Schuur Hospital in Cape Town and one of those involved in the trial, said results are promising. "We are using this method almost like a pap smear. We have found that the ability of direct vision inspection is as good as and sometimes better than a pap smear," she said. "This test will identify white lesions on the cervix that are pre-cancerous lesions, equivalent to what the pap smear will detect." Many countries in the developing world are unable to afford to implement a national screening programme for cervical cancer. Dr Denny believes this technique could offer them a viable alternative. Doctors at Groote Schuur Hospital buy their vinegar at a local supermarket. "It is not just cost effective it is also logistically a much simpler method of screening," she said. "No extra infrastructure is required and we are using the most rudimentary equipment." The only drawback to the vinegar test is that it sometimes suggests women have cervical cancer when they do not - so-called false-positive results. However, this also occurs with pap smears. "You end up over-treating large numbers of women," Dr Denny said. This story is featured in the radio programme Health Matters on the BBC World Service. A glossary of genome expressions Backcross: A cross between an animal that is heterozygous for alleles obtained from two parental strains and a second animal from one of those parental strains. Also used to describe the breeding protocol of an outcross followed by a backcross. Bacterial artificial chromosome (BAC): A vector used to clone DNA fragments (100- to 300-kb insert size- average, 150 kb) in Escherichia coli cells. Based on naturally occurring F-factor plasmid found in the bacterium E. coli. Base: One of the molecules that form DNA and RNA molecules. Base pair (bp): Two nitrogenous bases (adenine and thymine or guanine and cytosine) held together by weak bonds. Two strands of DNA are held together in the shape of a double helix by the bonds between base pairs. Base sequence: The order of nucleotide bases in a DNA molecule; determines structure of proteins encoded by that DNA. Base sequence analysis: A method, sometimes automated, for determining the base sequence. Behavioral genetics: The study of genes that may influence behavior. Bioinformatics: The science of managing and analyzing biological data using advanced computing techniques. This is important in analyzing genomic research data. Bioremediation: The use of biological organisms such as plants or microbes to aid in removing hazardous substances from an area. Biotechnology: A set of biological techniques developed through basic research and now applied to research and product development. In particular, biotechnology refers to the use by industry of recombinant DNA, cell fusion, and new bioprocessing techniques. Birth defect: Any harmful trait, physical or biochemical, present at birth, whether a result of a genetic mutation or some other nongenetic factor. Blast: A computer program that identifies homologous (similar) genes in different organisms, such as human, fruit fly, or nematode. ]]> <![CDATA[Bioinformatics policy calls for 51% FDI in govt labs]]> https://biospectrumindia.com/news/95/2373/bioinformatics-policy-calls-for-51-fdi-in-govt-labs.html https://biospectrumindia.com/news/95/2373/bioinformatics-policy-calls-for-51-fdi-in-govt-labs.html Fri, 11 Apr 2003 14:59:00 +0530 In a radical suggestion, a draft National Bioinformatics Policy 2003 of the Department of Biotechnology (DBT) has called for a total revamping of the existing programs. It has also recommended a reorientation of it to become resource oriented from infrastructure generation, and allow 51 percent equity by foreign companies and institutions in government funded research centers. The backbone of the country's bioinformatics segment is a network of 60 research centers, linked on a high speed computer network called the Biotechnology Information Systems Network (BTISnet). These centers are located in prominent universities, research institutes and academic institutions. Being government funded, these centers have been closed to the private sector and the vast infrastructure was available only for the national scientific community. The document called the Draft National Bioinformatics Policy 2003, stressed the need to accelerate the pace of the program to enable job creation, resource generation, and output maximization and provide BTIS with a competitive edge over other countries. And this can happen only with capital formation. To make this happen, the policy recommends: Allow foreign institutional investors, MNCs and academic establishments to invest in any chos en bioinformatics center with a ceiling of 51 per cent of equity. Allow foreign pharmaceuticals companies to outsource bioinformatics centers in all areas other than those of strategic relevance Encourage major international bioinformatics institutions like the NCBI (National Center for Bioinformatics), USA, EBI (European Bioinformatics Institute) UK, DDBJ, Japan and SIB etc, to open offshore centers using the in frastructure of the BTIS centers. Allow leading technology companies to invest in technology upgradation schemes with the bioinformatics centers. To facilitate these steps, the policy has also recommended the setting up of an independent autonomous institution, the Product Management Center of the bioinformatics program with control over the existing network. The policy paper has suggested that all resources of BTIS should be considered as national resources in higher education and made available to the entire scientific community. It has suggested evolving an integration protocol and ensures the resources are made available through a common portal. The portal should consist of, apart from factual data, utility services required for research, teaching and practices. Admitting that the government's bioinformatics program lacks the required level of interaction with the emerging bioinformatics industry, the policy has called for several collective steps such as: Develop an industry-institution partnership program both at national level and at central level Understanding the industry environment and market environ ment through techno-market surveys Inventorying the transferable technologies available within the BTIS network and making them available in the public domain Promote the growth of business incubators in the field of bioinformatics Provision for industrial and entre preneurial consultancy services Encourage enterprise creation through liberalized flow of foreign capital, outsourcing, infrastructure generation etc. Adequate emphasis on human re source development that suits the requirement of the industries  Promotion and protection on intellectual property rights. The government expects a national debate on the draft policy. While the draft policy is an important step in stimulating debate, despite its industry-oriented suggestions, there are several gaps. First, the policy has a limited view of the bioinformatics segment. It has failed to recognize the fact that the bioinformatics sector has today grown beyond the confines of government-funded laboratories. Perhaps, the policy's vision has been restricted to the DBT-funded operations. Essentially, it has failed to look beyond DBT's nose. Second, the policy has no solutions to offer to the problems faced by the fast emerging private industry in bioinformatics. This sector is is targeting global pharma players for providing them services. It is, however, stymied by the high cost of proprietary tools. Also, the lack of a national policy on promoting the development of human resources with defined quality is hampering the growth of the industry. Overall, recognizing even the shortcomings of the existing bioinformatics is a welcome sign, it would be appropriate if the final policy casts its net wide to ensure the emergence of a vibrant bioinformatics industry, rivaling the successful computer software sector. N Suresh ]]> <![CDATA[India rejects USAID's GM food aid]]> https://biospectrumindia.com/news/95/2858/india-rejects-usaids-gm-food-aid.html https://biospectrumindia.com/news/95/2858/india-rejects-usaids-gm-food-aid.html Fri, 11 Apr 2003 11:59:00 +0530 On 6 March 2003, after four-hour long meeting, the GEAC ruled out the possibility of import of GM corn-soya blend into India. The purpose of the meeting was to discuss the request of the two international NGOs operating in India, Co-operation for American Relief Everywhere (CARE) and Catholic Relief Services (CRS) for allowing them to import GM corn-soya blend from US for distribution amongst school children and the poor. The agencies were asked to get the consignments certified from the exporters that it does not contain any traces of Starlink Corn, a variety of corn banned for human consumption or any hazardous GM products, which they failed to oblige. The agencies had applied in June 2002 for permission to import a total of 23,000 tons of corn-soya blend. The CARE-India proposed to import 15,000 tons of GM corn-soya blend and the CRS about 8,000 tons from the US Agency for International Development (USAID), which gives food to these agencies free of cost. Pending, the decision of the GEAC, both the CRS and CARE-India booked a consignment of 1,000 tons. But this consignment could not land at the Indian shore as the GEAC finally rejected the plea for such imports in November 2002. Aggrieved at the GEAC's decision, the agencies appealed before the one-man Appeallate Authority that had fixed the date for hearing on 18 February. But before the actual hearing could take place both the CARE-India and the CRS withdrew their petitions. The GEAC was afraid that the said food aid from US might contain traces of the hazardous Starlink Corn, which is not yet approved for human consumption by the United States Food and Drug Administration. When the GEAC came out with a decision there were reports of traces of Starlink Corn slipping into US consignments to Japan, South Korea and Australia. Wait and watch Apparently, the GEAC does not want to take the risk of approving the import of GM foods aid from US and create problems in the country. According to reports, the GEAC does not have the expertise or the manpower to deal with checking, verifying, certifying, monitoring health impacts, labeling, even analyzing the impact on trade and other international agreements. In this case the USAID food aid was meant for people already vulnerable and there was no mechanism for post-aid disbursement surveillance. The government officials are of the opinion that why should we rush in?" when even approving a single consignment of food aid, or a crop like mustard which is wholly edible, would be viewed as a green signal for GM food and set a precedent of sorts. Need for transparent policy The Green Peace activists' recent seizure of the Monsanto R&D center in Bangalore shows that still people are opposing the GEAC's approval of GM cotton a year ago. What worries them is a new policy adopted by GEAC that it would consider imports of GM foods on a case-by-case basis rather than stick to its original blanket ban. The activists claim that the results of the commercial planting of GM cotton are not positive as the farmers in many states suffered massive losses. Before any more approvals on GM food, the government should announce a clear policy on GM foods. Even if it is a case-by-case policy, what are the issues, which need to be looked at each time, and what are the mechanisms, which need to be set in place? India's present laws on the import of GM food items are strict, but implementation has been poor, especially after the lifting of import regulations. Apart from this, the union environment ministry is also working on to make the decision-making process in GM food more transparent to educate people and meet the demand of activists that data on GM crops or food be made public. It's just at a thinking on the right path as officials are wondering as to how to go about this and what kind of data to make available on the web, for instance. The efforts should be speeded up to have a clear and transparent policy on GM food. Narayan Kulkarni ]]> <![CDATA[Ranbaxy ties-up with Microbia]]> https://biospectrumindia.com/news/95/1175/ranbaxy-ties-up-with-microbia.html https://biospectrumindia.com/news/95/1175/ranbaxy-ties-up-with-microbia.html Fri, 11 Apr 2003 11:55:00 +0530 The New Delhi based pharma major Ranbaxy Laboratories has announced a tie-up with biotechnology company Microbia to develop improved, higher-yielding biomanufacturing processes using precision engineering technology. The objective of the tie up is to apply precision engineering to produce pharmaceuticals with high efficiency and purity and to accelerate the process development cycle. "We hope this will be the first in a series of product collaborations with Microbia focused on advancing our biomanufacturing operations with cutting-edge biotechnologies." said Pushpinder Bindra, senior vice-president, Ranbaxy. Precision engineering is a comprehensive technology that targets the physiological control networks in fungi and bacteria to harness their metabolic potential. The technology is a systems-based approach to engineering the regulatory circuitry of microbial mini-factories used in industrial-scale production of pharmaceuticals and fine chemicals. Benefits of precision engineering include reduced process improvement cycle time and the ability to increase production without having to expand biomanufacturing facilities. ]]> <![CDATA[SII soon to release Hepatitis-B-DTP vaccine]]> https://biospectrumindia.com/news/95/2923/sii-soon-to-release-hepatitis-b-dtp-vaccine.html https://biospectrumindia.com/news/95/2923/sii-soon-to-release-hepatitis-b-dtp-vaccine.html Fri, 11 Apr 2003 11:55:00 +0530 The Pune-based Serum Institute of India (SII) is in the process of conducting phase III clinical trials for a Hepatitis B-DTP (Diptheria, Tetanus and Pertussis) combination vaccine. The SII medical director, Subodh Bharadwaj, said, "Research is going on but it is too soon to predict when the vaccine will be commercially available." The SII is the largest manufacturer of vaccines in the country and have seen growth in the Hepatitis B segment, with the share of its GeneVac B recombinant vaccine growing at about 37 percent during 2002 with sales of Rs 10.28 crore. Icrisat to set up agri-biotech park in AP The International Crops Research Institute for Semi-Arid Tropics (ICRISAT) is planning to set up an agri-biotech park as part of the Andhra Pradesh government's Genome Valley project. A memorandum of understanding is expected to be signed shortly with the state government. It has also taken steps to set up an agri-business incubator with the state participation. An international biotechnology colloquium, hoisted by the ICRISAT, has brought together stakeholders from the global to the local level from international and national research institutes, farmers' organizations, private sector, civil society to discuss ways to use cutting-edge technology for removing poverty. It also raised voices of concern on the transgenic crops and the need to put them through greater rigor on the field before large-scale use. Maximus2 launches ProjectX Maximus2 is launching a project lifecycle solution called ProjectX that offers a radically new way of managing people, processes and projects in a multi project environment. According to Priti Unadkat, director, Maximus2, ProjectX is completely browser based and enables any time anywhere access. It takes the pain out of managing, administrating and executing multiple projects. Team members can easily communicate and collaborate during project lifecycles. Unadkat said, Strand Genomics is an early adopter of ProjectX. ]]> <![CDATA[APNLBP develops transgenics for crops]]> https://biospectrumindia.com/news/95/2292/apnlbp-develops-transgenics-for-crops.html https://biospectrumindia.com/news/95/2292/apnlbp-develops-transgenics-for-crops.html Fri, 11 Apr 2003 11:53:00 +0530 The Andhra Pradesh Netherlands Biotechnology Program for Dryland Agriculture (APNLBP) that aims to promote application of biotechnologies relevant to small and marginal farmers has developed transgenics in castor, sorghum, pigeonpea and groundnut. These transgenics, currently being tested in laboratories, are expected to go to field trials in two years. The APNLBP Chairman, Dr MV Rao, said that it was for the first time in the country that the transgenics have been developed for the four crops. APNLBP had granted Rs 4.1 crore to set up the seven research projects. It had also sanctioned Rs 5 crore to different universities in Andhra Pradesh towards human resource development in biotechnology. Dr Rao said that APNLBP had also successfully developed technology for shelf life improvement of tomato. Using this technology, hybrid tomatoes could be preserved for 42 days while the local variety of tomatoes could be preserved up to nine days without being damaged. In the case of custard apple, initial experiments have shown that their shelf life could be extended up to 14 days. Experiments were in progress to standardize this technique and also to increase the shelf life further. APNLBP was currently promoting micro enterprises at the village level by providing technology and some revolving fund to educated unemployed youth. ]]> <![CDATA[The Biotech Bus]]> https://biospectrumindia.com/news/95/2045/the-biotech-bus.html https://biospectrumindia.com/news/95/2045/the-biotech-bus.html Fri, 11 Apr 2003 11:47:00 +0530 It is seen as the next big thing for mankind. It has been brewing for many years. It has an influence span that extends across all races and countries. Its applications are spread over all facets of human life. It gets talked about. It gets read about. It has many supporters. It is biotechnology. Many people see huge opportunities for India in this area. It has the potential to be another information technology like success story. Yet it is not quite there. The hype, the presence, visibility - call it what you want - is not muted. And the potency is strangely subdued. So what is missing? Is the concept fuzzy? Maybe the very vastness of the subject makes it difficult to get hold of. Like a huge round ball covered with oil rolling on a smooth surface. It is very difficult to get hold of it and give it a sense of direction. Biotechnology - the set of techniques used for developing biological systems and processes - covers many areas. Human and animal health care, agriculture, industry, drugs and perhaps some time in the future even computing. The products that result from these areas include vaccines, transgenic crops, protein drugs, seeds and much more. For technology to spread and for larger absorption in society it is required that it's many facets are disseminated over a larger community. It is estimated that there are less than 1,000 companies working in the area of biotechnology with an employment of 20,000 people. In the modern biotech sector there are hardly 70 to 80 companies. If this number has to increase the awareness and potential need to be increased. The vastness also hampers the defining of measures. The Chinese say that what cannot be measured cannot be improved. So if India wants to be one of the countries driving the biotech bus then it would be a good idea to get some definitions in place and measures found to see progress. These could be selected from many options - investments, employment, revenues, patents - but some measures are required. The government agencies need to get this done as soon as possible. Or maybe there is need for an association to step in and work on these aspects. Probably the first step that is required is a mapping of the industry. So that future roadmaps can be established. Having done that the next imperative would be to make the sector grow. In a noise infested, clamor crazy world the next thing that is required is a drum and a drum-beater. Today there is no single champion and no common beat for the entire community. That comes in the way of growth. A movement works if it has champions. Biotech has few. And they are also not extremely visible. And once the drummer is in place what are the tunes that should be played? Tunes that people love to hear and which fuel the growth of the industry. Venture capital is one. Talk about the investments that have been made and it attracts others. After all there are many who believe that venture capital is vulture capital. Not quite true. But once some of the capital is in place talking about that gets some more. There is nothing amazingly new about this. Money has always attracted more of the same. So how much money has been invested in the Indian biotech sector? It maybe not be huge today but the fact that it is happening is enough to get others interested. Someone needs to collect this data and talk about it - loudly. Market capitalization is another drum beat that is liked by everyone. So who are the big names here? What are their valuations? It is early days for this sector to throw up glamor leaders but no harm in checking out the potential winners and projecting them as such. There are many pharma companies doing very well in the capital markets who also have biotech initiatives. Can these be highlighted? They have to be projected as the role models. After all aspiration building is the single greatest momentum creator. What about the discoveries and the research ? What does biotech do for the individual? Or in information technology terms - which is the killer application? Which are the developments in the last five years that have made the world a better place to live in? And which are the ones in the pipeline? Talking about these in a simple manner is a huge unfulfilled need. Can biotech contribute to solving India's problems ? Can it help create a prosperous, productive and pleasant place ? Consider that we have a billion plus people. Consider that we have a huge percentage of them involved with agriculture. Consider that biotech's major application areas span health and agriculture. The answer is obvious. It would help if that message got spread around a bit. Another excitement point is the global role for India? It is a big drum. It helps the country find its place in the global community. And success there acquires a different dimension and a new meaning. So which are the success stories sitting there? We need to share them across many communities. Biotechnology is ready to come out of the closet. It is time for it. And this is one bus India does not have to miss. In fact it should not catch it also. India should be one of the drivers. It has all that it needs. It should be driving the Biotech Bus. What we have tried to do above is spell out the agenda for BioSpectrum. We believe it is also the agenda for this industry and this country. We will seek to raise issues and propagate solutions. With the help of the policy makers, the industry, the researchers and others. Shyam Malhotra (The author is the Editor-in-Chief of BioSpectrum and other CyberMedia publications) ]]> <![CDATA[Interspice creates new applications for Lactic Acid]]> https://biospectrumindia.com/news/95/4759/interspice-creates-new-applications-for-lactic-acid.html https://biospectrumindia.com/news/95/4759/interspice-creates-new-applications-for-lactic-acid.html Fri, 11 Apr 2003 11:43:00 +0530 The application for lactic acid in India has been mainly restricted to its use in the manufacture of IV fluids in the pharmaceutical sector. Chennai based Interspice Biotech Pvt. Ltd, has over the last two years been successful in creating new markets for lactic acid by developing applications in the food, industrial and cosmetics sectors. "Worldwide lactic acid is seen as a viable food ingredient but there has been no conscious effort to develop the market in India," said Aruna Rangachar, director, Interspice Biotech. Lactic acid is used in the food sector in beverages, dairy, confectionery, meat, fruits and vegetables etc. The main function of lactic acid is to serve as a buffering agent, pH regulator, flavor enhancer, anti microbial agent etc. At a global usage level upto 80 percent of lactic acid usage is in the food segment. "The food industry is key for lactic acid. In India there has hardly been any significant usage of lactic acid in the food sector and from almost a zero base, we have created a 200 tons market in India," added Rangachar. Interspice has a business alliance with Belgium based Galactic sa/nv to market lactic acid and its derivatives for the Indian market. Galactic is amongst the leaders in the lactic acid segment where other major players are Purac of Netherlands and ADM of United Kingdom. Using sugar as stating substrate, lactic acid is fermented at various purity levels depending on the application. ]]> <![CDATA[JK Pharma: Inching its way to profitability]]> https://biospectrumindia.com/news/95/2363/jk-pharma-inching-its-way-to-profitability.html https://biospectrumindia.com/news/95/2363/jk-pharma-inching-its-way-to-profitability.html Fri, 11 Apr 2003 11:42:00 +0530 JK Pharmachem Ltd (JKPL), part of the JK Organization, which manufactures Penicillin- G had recorded its maiden profit of Rs 7crore during its last financial year ending in September 2002. The first six months of the current year has not been a smooth ride but the company is confident of continuing the profitable performance of the previous year. JKPL had made an investment of Rs 200 crore into the Penicillin-G project which has its manufacturing base in Cuddalore in Tamil Nadu but has made a loss of Rs 100 crore to date. "The total market demand for penicillin is 13,500 mega million units (MMU), where the domestic demand is 7,000 MMU and the domestic production is 9000 MMU. Presently there are only 8-9 penicillin consumers in the domestic market. Any pressure on them will affect our cash flow," said Dr SK Sagar, president, JKPL. Accredited with ISO 9002 certification, JKPL has been successful in increasing productivity levels at its manufacturing facility in Cuddalore. Dr Sagar also stated that the Chinese are posing a threat to Indian companies because energy costs are lower than in India and that China is building its Penicillin manufacturing capacities. In order to counter the Chinese effect, JKPL is making several efforts to reduce energy costs including in house generation of power. The other competitors in this field are Torrent Gujarat Biotech Ltd (TGBL) and SPIC. ]]> <![CDATA[TN covets biotech investments]]> https://biospectrumindia.com/news/95/1746/tn-covets-biotech-investments.html https://biospectrumindia.com/news/95/1746/tn-covets-biotech-investments.html Fri, 11 Apr 2003 11:41:00 +0530 Tamil Nadu chief minister J Jayalalithaa has advocated large scale public and private partnerships (PPP) and investments in biotechnology in the state. Inaugurating the twin conference on Investment Meet and Infrastructure Development organized by Confederation of Indian Industry (CII), she said Tamil Nadu offers excellent opportunities for broad basing investments in IT and Biotechnology in all its metropolitan towns like Coimbatore, Tiruchi, Madurai, Tirunelveli, Salem and Erode. These towns are linked by an extensive network of nearly 5,000 km of optical fiber cables that to the international gateway located in Chennai. Visualizing PPP as a winning model, the Tamil Nadu government will harness this strength to encourage foreign investment in the state to make it the hub of the knowledge industry in South Asia. Biotechnology is another area where the state hopes to get good investment from all over the world. The TIDCO Center for Life Sciences (TICEL), a Biotechnology Incubator Park in collaboration with Cornell University will be set up this year to enhance investment in this segment. "This will be a nucleus for entrepreneurs and research laboratories to incubate their ideas and convert them into profitable business ventures." ]]> <![CDATA[Ranbaxy granted USA FDA approval]]> https://biospectrumindia.com/news/95/2871/ranbaxy-granted-usa-fda-approval.html https://biospectrumindia.com/news/95/2871/ranbaxy-granted-usa-fda-approval.html Fri, 11 Apr 2003 11:41:00 +0530 Ranbaxy Laboratories Limited (RLL), received the approval by the US Food and Drug Administration to market Amoxicillin and Clavulanate Potassium for Oral Suspension USP, 200 mg/28.5 mg (base)/5 ml and 400 mg/57 mg (base)/5 ml. The Division of Bioequivalence has determined the Ranbaxy formulations to be bioequivalent and, therefore, therapeutically equivalent to Augmentin® for Oral Suspension*, 200 mg/5 ml, and 400 mg/5 ml, respectively, of GlaxoSmithKline. Augmentin® has combined sales of $1.2 billion with total sales of $272.5 million in the suspension market (IMS - MAT: December 2002). Amoxicillin and Clavulanate Potassium for Oral Suspension is indicated for the treatment of infections caused by susceptible strains of the designated organisms in the conditions like Lower Respiratory Tract Infections, Otitis Media, Sinusitis, Skin and Skin Structure Infections, and Urinary Tract Infections. While Augmentin® is indicated only for these conditions listed above, infections caused by Ampicillin-susceptible organisms are also amenable to Augmentin® treatment due to its Amoxicillin content. Commenting on the approval, Dipak Chattaraj, president and CEO of Ranbaxy Pharmaceuticals Inc., USA, said. "We were delighted to make yet another dosage form of Amoxicillin available based on the skills and talents that are available through our parent company, Ranbaxy Laboratories Limited. This again demonstrates our depth and breadth of expertise to add to our expanding product portfolio, along with our commitment to bring generic alternatives to the US healthcare system. We are adding yet another product that has clinical utility and value, and as such, will distinguish Ranbaxy in the years to come". Sales and marketing for this product will be supported by the Ranbaxy Sales and Marketing Group and product will be made available to all dispensing outlets located throughout the US including chain pharmacies, wholesalers, and generic distributors as soon as inventories are achieved to support market requirements. Ranbaxy Laboratories Limited, India's largest pharmaceutical company, manufactures and markets branded generic pharmaceuticals and Active Pharmaceutical Ingredients. Ranbaxy's continued focus on R&D has resulted in several approvals in developed markets and significant progress in New Drug Discovery Research. Ranbaxy's foray into Novel Drug Delivery Systems has led to proprietary "platform technologies" resulting in a number of products under development. The Company is selling its products in over 70 countries and has an expanding international portfolio of affiliates, joint ventures and alliances, ground operations in 25 countries and manufacturing operations in seven countries. ]]> <![CDATA[More firms to release]]> https://biospectrumindia.com/news/95/2854/more-firms-to-release.html https://biospectrumindia.com/news/95/2854/more-firms-to-release.html Fri, 11 Apr 2003 11:40:00 +0530 Bt cotton seeds Considering the positive and favorable response to transgenic Bt cotton, few more companies are preparing to release their genetically modified cotton hybrids for commercial use shortly. According to a study conducted by Rabobank International seven companies â€” Mahendra and Paras of the Emergent group, Nath Seeds, Ankur Seeds, Ajeet Seeds, Raasi Seeds, Krishi Dhan and Nuziveedu Seeds â€” are preparing to release their Bt cotton hybrids for commercialization by 2006. The study says that in near future multinational companies could invest more to develop or outsource capabilities in transgenic technologies. Chhattisgarh to offer incentives for biotech industry To boost the biotech industry, Chhattisgarh is planning to provide a package of incentives like tax rebates, single-window clearance and a dedicated Biotech Park. According to reports the state cabinet is also considering the announcement of a comprehensive biotech policy. The government has been encouraging private investment in all the areas of biotechnology. The biotech industries located in rural areas are eligible for all incentives and exemptions available to rural industries. The state's network of biotech park may come at Bhilai and Rajnandgaon and the government is expected to provide an initial support of Rs 10 crore to the park project. Karnataka to participate in Washington Bio expo Karnataka will participate in the three day Biotechnology Industry Organization Exhibition to be held in Washington DC. The exhibition will be held at Washington Convention Center from June 23 to 25. The participation will help the state to show case its strength and infrastructure facilities available to attract the investors and venture capitals to invest in the state. Applications for funds dropped In the last couple of years, the number of applications for funding the biotechnology ventures has dropped drastically, said Alok Gupta, associate director, Head Life Sciences & Biotechnology, Rabo India Finance Pvt Ltd. Earlier Rabo India used to receive 2-3 proposals a week. But now the industry has understood the hard realities. Inspite of many market risk factors, he said, Rabo India has been funding 15 pharma companies for their different activities like clinical trials, discovery process, healthcare sectors etc. For SMEs, he said, Rabo India is providing advisory services in order to get funds to continue their new/present projects. SII soon to release Hepatitis-B-DTP vaccine The Pune-based Serum Institute of India (SII) is in the process of conducting phase III clinical trials for a Hepatitis B-DTP (Diptheria, Tetanus and Pertussis) combination vaccine. The SII medical director, Subodh Bharadwaj, said, "Research is going on but it is too soon to predict when the vaccine will be commercially available." The SII is the largest manufacturer of vaccines in the country and have seen growth in the Hepatitis B segment, with the share of its GeneVac B recombinant vaccine growing at about 37 percent during 2002 with sales of Rs 10.28 crore. ]]> <![CDATA[Modi invites biotech firms to Gujarat]]> https://biospectrumindia.com/news/95/2510/modi-invites-biotech-firms-to-gujarat.html https://biospectrumindia.com/news/95/2510/modi-invites-biotech-firms-to-gujarat.html Fri, 11 Apr 2003 11:38:00 +0530 Narendra Modi, chief minister of Gujarat, has invited biotech entrepreneurs to invest in Gujarat. He has promised the state government will take all steps to facilitate investments. He emphasized that Gujarat was suited to attract a large part of the growing bioinformatics and contract research markets. He made this appeal to industrialists at the Biotech India 2003 recently. The chief minister stressed the need to make India the global bioinformatics headquarters. This was possible because we could build on our successes in information technology and combine that with our skills in biology and chemistry, he said. Modi also focused on the need to invest in five areas of biotechnology and pharmaceuticals, agriculture biotechnology, industrial enzymes, and the two new areas of environment biotechnology and marine biotechnology. ]]> <![CDATA[Nunhems Seeds suspends work on transgenic crops]]> https://biospectrumindia.com/news/95/2374/nunhems-seeds-suspends-work-on-transgenic-crops.html https://biospectrumindia.com/news/95/2374/nunhems-seeds-suspends-work-on-transgenic-crops.html Fri, 11 Apr 2003 11:31:00 +0530 The lack of clear government policy on allowing the entry of genetically modified food items in the country is making companies do a rethink. India's third largest seed supplier, Nunhems Seeds Pvt Ltd, a fully owned subsidiary of the Dutch conglomerate, Nunaza, has suspended its research work on transgenic vegetable crops in the country. " The rate of recovery of investments in transgenic vegetable seeds is low because there are not many niche segments. Due to the uncertainty over the regulatory policies, it was not feasible to continue the investments in the development of transgenic vegetable seeds," said Dr Arvind Kapur, MD, Nunhems Seeds. However, we are continuing our work on transgenic cereals, he added. The company has been working on transgenic mustard seeds 1994 in India. The Indian unit of Nunhems was incorporated in 1995 with Hyderabad as headquarters. While the corporate office is in Gurgaon, Haryana, the company has its research center in Bangalore and a production unit in Andhra Pradesh. Sunseeds is the US counterpart of Nunhems. Dr Kapur said the government was not clear about labeling of food items and the whole process is in a transitory phase. Because of this it was difficult to have control over project costs. Nunhems develops varieties, which create value by insect and disease resistances and interior and exterior qualities such as taste, color, long shelf and field life. Through its specialized brand name HILD, Nunhems devotes considerable attention to bioseeds. Nunhems principal products are tomato, melon, leek, asparagus, cucumbers, salads, chicory witloof, processing crops and watermelon. ]]> <![CDATA[Assocham demands National Biotech Policy]]> https://biospectrumindia.com/news/95/2449/assocham-demands-national-biotech-policy.html https://biospectrumindia.com/news/95/2449/assocham-demands-national-biotech-policy.html Fri, 11 Apr 2003 11:31:00 +0530 The Associated Chambers of Commerce and Industry (Assocham) has urged the government to formulate and announce a National Biotech Policy to develop India as a global biotechnology industry hub. The move was made at the concluding session of the three day - III Knowledge Millennium Summit - with the theme 'The Business of Biotechnology' held at New Delhi from March 21- 23. Stressing the need for formulation of a National Biotechnology Policy, the summit further recommended adoption of biotechnology, biofertilizer, biopesticides, etc. on emergency footing. Since Indian agriculture is in an emergency situation, doing more of yesterday, therefore, would not take us forward. The chairman of the Assocham Knowledge Millennium Committee, KL Chugh, releasing the 10 point charter, said the summit recommended for an immediate establishment of a National Biotechnology Development Fund with an outlay of around $1 billion and an autonomous management structure to develop this infrastructure and institutionalization of a Biotechnology Regulatory Commission as the single window mechanism for biotechnology policy and regulation. It also underlined the need for larger investment in the area of functional genomics of agricultural crops and animals to identify important genes for genetic improvement. As Assocham believes, "Rich scientists create Rich India", it urged the government to create an enabling environment for biotechnologists in publicly funded institutions to graduate to `biotechnopreneurs' by permitting them to hold `sweat equity' in private companies. ]]> <![CDATA[Bioinformatics meet in Hyderabad on April 5-6]]> https://biospectrumindia.com/news/95/1205/bioinformatics-meet-in-hyderabad-on-april-5-6.html https://biospectrumindia.com/news/95/1205/bioinformatics-meet-in-hyderabad-on-april-5-6.html Fri, 11 Apr 2003 11:29:00 +0530 The Bioinformatics Society of India (INBIOS), is organizing a meeting of its members as Brainstorm 2003 at Nizam College, Hyderabad, on April 5-6. The society formed by bioinformatics professionals in India and abroad has been meeting mostly in cyberspace. Recently it had a meeting on the ground in Chennai. INBIOS coordinator Ashwin Sivakumar said bioinformatics is in a transitive phase in India and this calls for the industry and academia to work together to set an ideal launch pad for making proper bioinformatics initiatives for the years to come. Sivakumar is a bioinformatics programmer at University of Helsinki, Finland. This event also is an opportunity for bioinformatics enthusiasts to get to know the latest in the bioinformatics trends and technology. India being a developing country, only a select list of institutions gets access to sophisticated tools and high quality journals. Thus we are encouraging people to submit summaries of already published technical papers (may not be their own paper) as power point presentations so that this can be a group learning session for enthusiasts and researchers in this field to get a know how of various research sub-branches, he said. For more details contact info@inbios.org or bioash@mgspeed.com ]]> <![CDATA[Need for clarity]]> https://biospectrumindia.com/news/95/2275/need-for-clarity.html https://biospectrumindia.com/news/95/2275/need-for-clarity.html Fri, 11 Apr 2003 11:12:00 +0530 Bt cotton seems to have a unique place among seeds in India. When it had almost faded from public memory after formal approval was granted for its use by the government last March, the campaign against it had subsided. Now a year later, a virulent campaign against Bt cotton has started. The latest episode was the ugly protest by a coalition of opponents from non government organizations (NGOs) led by Greenpeace at Monsanto's research center in Bangalore. The protests are also fueled by lack of accurate information about the results of the first year's crop yield from Bt cotton. The only definite statement by the government in Parliament indicated that the Bt cotton yields were satisfactory. However, ministers in various states have issued contradictory statements. Cotton farmers in Andhra Pradesh have hinted at Bt cotton failure and have even attributed some farmer suicide cases to Bt cotton crop failure. They have even talked about lower cotton yields and increased use of pesticides in Bt cotton crop. On the other hand, Monsanto, the developer of Bt cotton, is firm that the first year's crop was not a failure. After all, the transgenic seed provides good resistance against the major cotton pest, Bollworm, and does not claim to act effectively against other pests or increase crop yields. Opponents of Bt cotton have demanded compensation from Monsanto to Bt cotton farmers. As public protests and debates continue, the Bt cotton episode has raised some serious issues. Which is the correct forum to debate what is essentially a scientific issue? The streets or research labs or Parliament? In this case, all these three fora have failed to be on any help. Food policy expert Devinder Sharma laments the fact that the Indian scientific community has so far failed to offer an independent view on the controversy, perhaps weighed by the lack of funding mechanisms independent of the government or private companies. In a country with a functioning legal system, the streets are certainly not the place to debate such a controversial issue. After all, Monsanto has marketed the Bt cotton seed after complying with all regulatory processes and farmers have bought it not under any compulsion. Parliament has yet to debate the issue meaningfully and the blame for this should be placed at the doors of the regulatory agency, the Genetic Engineering Approval Committee (GEAC) of the Ministry of Environment. The onus is on the GEAC to share the relevant data with the public and clarify the correct position amidst the claims and counterclaims. It will be better if the opponents of Bt cotton and other genetically modified products force a debate involving the GEAC and other government agencies such as the Department of Biotechnology and the Indian Council of Agricultural Research (ICAR) who have the expertise on this topic. As public interest is the paramount issue here, the Bt cotton debate could be the forerunner of the government initiative to engage the people in decisions that affect their lives. Geneticallly engineered products are here to stay. The march of technology can at best be slowed down and not stopped. Let us set an example to the world by debating this issue in a civilized way and not decide these things on the basis of street power. ]]> <![CDATA[On health super highway with biotech drugs]]> https://biospectrumindia.com/news/95/2546/on-health-super-highway-with-biotech-drugs.html https://biospectrumindia.com/news/95/2546/on-health-super-highway-with-biotech-drugs.html Thu, 10 Apr 2003 18:53:00 +0530 It's circa 2010. A baby is discharged from a hospital somewhere on the planet few days after birth. Along with baby care instructions, the hospital also hands over a digital video disk (DVD) or a CD-RoM. No, it is not some games to keep the baby entertained. The disk contains the entire genetic code of the baby. And it will help doctors to tailor their treatment regime for the baby for decades to come. " Such a scene will become common place in 10 years," predicts Dr Craig Venter, the celebrated president of The Institute of Genomic Research (TIGR) and the co-author of the human genome. The genetic code will provide clues to the increased risk factors of particular diseases the baby may be prone to in the future. It will also provide information about the effectiveness of drugs for various treatment the individual may require during the life time. Most of the drugs in use now work effectively only in 30 to 50 percent of the population. And in cancer treatments, thereapeutics work effectively only in 20 to 30 percent cases.However, doctors are forced to give them to all hopes on the assumption that these drugs. So with the genetic information, pharma companies will be able to design drugs that would actually treat a disease and not kill the patient. " Initially the pharma industry has been vary of this because they were afraid it is going to decrease their markets instead of giving the drugs to every body. But in the meantime the leading companies have realized that they have no ethical choice and that in fact this will lead to increased diversity of drugs," said Dr Venter. Welcome to the future world of personalized medicine. This is a segment which is heavily dependent on biotechnology. Gene therapy is likely to be one of the hottest segment of the future. Here, scientists attempt to treat diseases at the genetic level itself. Some of the diseases are caused by defective genes which result in non-production of required proteins. Armed with the information about the human genome, scientists are aiming to locate the specific genes that cause the problems and reprogram it to correct the problem. So far some 250 types of gene therapy treatments are under various stages of advanced research. The first successful gene therapy has yet to get regulatory approval. However, scientists have been able to rely on the self-healing capabilities of the human body extensively to cure various diseases in the last 20 years or so. There are several such drugs and treatments approved for safe use by the US governments Food and Drugs Adminstration(FDA), the world's most-respected drug regulatory authority. These include treatments for anemia, cystic fibrosis, growth deficiency, hemophilia, hepatitis, genital warts, organ transplant rejection treatments and leukemia and many other cancers. Among the first biotech treatment available was the replacement protein therapy for Factor VIII, a protein that induced blood clotting in hemophiliacs, people who lack this capability. The other famous one is insulin, a protein hormone that regulates glucose levels in blood and its inadequate supply leads to diabetes. " In 1982, we marketed the world's first biotech product, rDNA Human insulin. In1996, we became the first company to launch the world's first recombinant Human insulin analogue, Humalog [insulin lispro], " said Rajiv Gulati, chairman and managing director of Eli Lilly and Company's Indian wing. Eli Lilly is one of the world's leading pharma companies with increasing focus on biotech-based products. Gulati said in 2002, Lilly brought to market the world's first and only bone building agent for post-menopausal osteoporosis- Forteo [teriparatide]. Last year, the company also received the Translational Medicine Award cosponsored by Univ. of California and San Diego Institute of Molecular Medicine in recognition of Lilly's new biotech product-Xigris [Drotrecogin Alfa]. The sales of insulin and insulin analogue last year touched $1.9 billion and Xirgis raked in revenues of over $ 100 million in in over 140 countries. According to the US-based Biotech Industry Organization (BIO), more than 325 million people in the world have benefited from 130 biotech products approved by the US FDA. Interestingly, over 70 percent of these drugs and vaccines were approved in the last six years. Currently, some 350 biotech drugs are in the clinical trials stage for 200 diseases. Some of these include various types of cancers, Alzheimer's disease, heart disease, diabetes, multiple sclerosis, AIDS and arthritis. A Confederation of Indian Industry (CII) survey said at least eight industrial units are producing recombinant DNA products. Take the case of Mumbai-based Wockhardt. It introduced a hepatitis-B vaccine, Biovac-B, in early 2000. " We are now the market leader in this segment," said Wockhardt chairman Habil Khorakiwala. In fact, it got another global recognition when its manufacturing facility was certified by the World Health Organization (WHO) as a GMP ( global manufacturing practice) compliant facility, the first Indian plant to achieve this for its bulk and formulation facilities, Khorakiwala said. Wockhardt has followed it up with the launch of Wepox, a human Erythropoietin, in early 2001 to treat a critical type of anaemia due to cancer or kidney failure. This product has a 25 percent market share now. Wockhardt chairman said these two biotech products accounted for 10 percent of the company's sales revenue in 2001. Khorakiwala said both these products will be launched in the international market soon. According to a recent study by Tufts University, it costs approximately $ 800 million ( Rs 4,000 crore) to bring a new chemical drug to the market in 15 years. The biological alternates will take less than half this time. Experts say that the distinction between pharma and biotech companies is blurring fast. It is spurred by the fact that future drugs could be delivered through food items ( vaccine fortified vegetables or cereals or edible vaccines) and not through pills, potions or injections. Biotech based diagnostic kits have become very popular in recent years. There some some 600 diagnostic kits and products in the world market notching up sales of $ 20 billion ( Rs 100,000 crore). The sale of these diagnostics in India is estimated to be Rs 100 to 200 crore annually. Most of these kits are imported. Companies like J Mitra and Co in India are marketing AIDS diagnostic kits manufactured from technologies developed by a government laboratory. In fact, the Department of Biotechnology (DBT) has facilitated the transfer of technology for 11 diagnostic kits to the industry. Major research programs are on in India to develop cures for diseases such as tuberculosis, HIV, malaria, leishmania, cholera, dengue, typhoid, cancer and heart diseases. Vaccines are under development against cholera and rabies. " I see a great scope in diagnostics and vaccines in India. We can become the world leaders only when we come out with new molecules. We can compete with major players in biopharma," said Prof G Padmanabhan, honorary professor at the Indian Institute of Science, Bangalore. " We have to go for indigenous drugs. Already many firms in India are developing such drugs. I hope they will come out with good results soon." Sure. Indian companies are working on development of new molecules. Nicholas Pirmal India Limited, Mumbai, is a key player in this segment. " The business driven R&D ( BBRD) is a major activity at our research center, the Quest Institute of Life Science," said the company's director( strategic alliances and communications, Dr Swati Piramal. Nicholas Piramal has filed a patent application for a new anti-cancer molecule, NP102. This molecule is a cyclin-dependent kinase 4 inhibitor. It is also working on five other compounds in areas such as cardiovascular (two), and one each in diabetes , anti-fungal and cancer . " We have completed the first phase of the 12-year project. Each project will cost around Rs 12 crore," she said. Eli Lilly has just launched Forteo, a recombinant Teriparatide in the US market recently." We are looking at a late 2003 launch in India and this drug is expected to be Rs 8-10 crore product in the first year of launch, said the company's CMD Rajiv Gulati. The heartening fact is the recent study by Ernst & Young which expects the Indian pharmaceutical industry to growth exponentially to an innovation-led $ 25 billion industry by 2010. The market capitalization of this sector may reach $ 150 billion from mere $ 5 billion generic-based sector right now.The industry was worth $ 3.8 billion in 2000 and may grow to $ 9 billion by 2005. From all available information, Indian biopharma companies are placed firmly on the path of a successful journey on the health superhighway with biotech drugs. N SureshTapping the CRO marketWith the global pharmaceuticals companies looking outward to reduce their ballooning research costs, countries like are in a good position to tap the new business opportunities. Countries with excellent training and experience in process development, manufacturing and formulations such as China, India, Russia, South Korea, Thailand and Malaysia are the major destinations for contract research opportunities (CRO) market. The global market for such services in 2002 was estimated to be $ 1.2 billion (Rs 6,000 crore) and may grow to $ 3 billion (Rs 15,000 crore) in 2008. " India has a distinct advantage over its competitors," said Gautam Das, COO, Syngene International Ltd, Bangalore. India's competitive edge is in cost efficiency, the intellectual talent pool in biosciences, synthetic chemistry and information technology.This Bangalore-based Biocon group company is India's first CRO firm in biotechnology. Syngene was set up in 1994 to meet the emerging demand for outsourced research from Europe and the US. Syngene has clocked $ 6 milliion (Rs 30 crore) in revenues in 2002-03 and its growth rate was in excess of 75 percent. Syngene's clients include AstraZeneca, Bristol Myers Squibb, DOW Chemicals and Glaxo Smithcline Beecham. Global companies are looking at ways to speed up the drug discovery process by simultaneous screening of a large number of potential new molecules and identify promising ones quickly. In addition, Indian companies have good potential in developing new chemical entitites (NCEs) from natural remedies and plant-based materials, according to a Rabo India report. Top 10 pharma companies may increase their primary screening of compounds from 10-15 million now to 200 million per year in another two years. Besides Syngene, Chembiotek is a major player in this area. Similarly, contract manufacturing is a major opportunity area. Recently, Hyderabad-based Bharat Biotech has got a major order to manufacture a vaccine for Wyeth. And Eli Lilly plans to make India as the global hub for its global requirements." We are already looking at alliances with Sun Pharma, Ranbaxy and Austin-Shasun. We want to act as a catalyst and provide the world class manufacturing facilities of some operators in India to our parent company for meeting their global requirements. Nizatidine and Dobutamine are two drugs that may soon start to be exported from these third party manufacturers to meet global markets," said Eli Lilly(India) chief Rajiv Gulati.The vaccine makerThe Hyderabad -based Shantha Biotechnics is the first Indian company to develop the recombinant DNA vaccine in a segment dominated by global pharma major.A small-time entrepreneur with limited ambitions broke several myths and reworked the paradigm in the 1990s. Shantha Biotechnics is the brain child of Varaprasad Reddy, an electronics engineer by training and experience, achieved in a field that India's leading pharmaceutical firms did not have the courage to tackle till then: genetically engineered drugs. Shantha is a company engaged in the development, manufacturing and marketing of biologicals/biopharmaceuticals for human healthcare. Varaprasad Reddy, managing director, Shantha Biotechnics, who is instrumental in developing indigenously- rDNA vaccine (Shanvac-B) at a cost less than Rs 20 crore, albeit over a five-year period, says, "R&D is our core competence. And the company's success can be mainly credited to its team of highly qualified and world-class scientists in the R&D team." Shantha has received several awards, the most prestigious being the first ever cross industry 'National Technology Award' and 'The Ernst & Young Entrepreneur of the year Award'. With half a dozen of the country's most prestigious technology awards to his credit, Reddy said, "We will launch a new drug every year for the next six years. At present our manufacturing capacity is 100 million doses of Shanvac B and 2 million doses of Shanferon annually. Our hepatitis B vaccine (Shanvac B) is WHO approved and we supply to the UNICEF. Our global markets are Russia, Kenya and South Asian countries. Shantha had an export sale of Rs.60 lakh in the year 2001-02. About the action plan of Shantha, Reddy said, "We will focus on manufacturing and drug discovery. The company is extending its manufacturing facility to facilitate manufacture of its various products. Shantha's new drug discovery program involves work on monoclonal antibodies against non-small-cell lung carcinoma. The products in the pipeline are Shantyph (Typhoid vaccine), Shankinase (Streptokinase), Neisvac C (Meningococcal infection), DPT-Hep B combivac and Insulin among others." "On the regulatory and fiscant bottlenecks that the government has to remove to make India a global market for biopharma research and related activities, Reddy said, "A single window approval of biopharmaceuticals (like the CBER in USA) will cut down on the time to market and costs. The current system of seeking approvals from various departments is time consuming. There is also no level playing field. On one hand the government encourages indigenous manufacturers and on the other hand the import of vaccines still continues. This is a scenario even when the Indian companies have proved that their product quality matches international standards and the companies are more than capable of meeting the domestic demand." First Indian biotech drug gets US patent Indian companies are making rapid strides in developing biotech based drugs. Hyderabad-based Bharat Biotech has got the US patent for the first Indian biotech drug-Lysostaphin which can treat infections caused by a fearsome bacteria, Staphylococcus in humans and animals. Dr Krishna M Ella, chairman and managing director, Bharat Biotech Bharat Biotech chairman and managing director Dr Krishna M Ella said that the drug was undergoing animal trials. It got the US patent last year. Developed jointly by his company and the Delhi-based Institute for Genomics and Integrative Biology, Lysostaphin, a biological protein can kill the germs in 40 seconds after it degrades inside the body on intake. Test results claim this drug was more effective than its chemical counterpart. Bharat plans to mass-produce it at the rate of two gram per liter at its manufacturing facility in Hyderabad, Dr Ella said. The annual global market for this drug is estimated at $ 12 billion ( RS 58,000 crore). Set up in 1996 by Dr Ella, a US-trained molecular biologist, Bharat Biotech is a trailblazer in Indian biopharma sector. Its recombinant vaccine for hepatitis-B, Revac-B, hit the market in 1998. Today it is sold in many foreign countries. Dr Ella said the vaccine was made in India when the international management consultancy, McKinsey, ruled out any Indian company developing the expertise to make this high tech vaccine. " Having proved our point that we can do it, now we are concentrating on other vaccines, " he emphasized. Bharat Biotech was the first company in the world to perfect the technology that permits the purification of the hapatitis-B surface antigen without the use of toxic heavy metals. The company has the capacity to produce over 100 million doses a year. Bharat Biotech has patented the HIMAX technology which was developed in house to enable recovery of the surface antigen protein to the tune of 85 approximately. The global average recorded in the scientific literature is only 12-20 percent. At the heart of the company is the 375,000 sq. ft clean room manufacturing facilities, one of the largest in Asia. The company has invested over Rs 125 crore and had annual sales of Rs 27 crore last year. Bharat has alliances with some top Indian and foreign institutions such as the Indian Institute of Science, Bangalore, the Center for Biochemical Technology, Delhi, the International Center for Genetic Engineering and Biotechnology, New Delhi, the Center for Disease Control, Atlanta, and the National Institute for Allergies and Infectious Diseases, Washington D.C. Hepatitis-B market shares by revenues The company is developing other biological vaccines against rabies, Japanese encephalitis, a vaccine against malaria and a vascular endothelial growth factor. Bharat also has products like recombinant streptokinase, a protein produced from genetically manipulated Escherichia coli and urokinase, a plasminogen activator useful to treat acute myocardial infarction, pulmonary embolism, etc. A typhoid vaccine is ready for release in early April. " We have just got the license for the typhoid vaccine," said Dr Ella. The typhoid vaccine has been prepared in collaboration with the National Institute of Child Health, US, under the guidance of Dr John Robins. It will be at least one-third cheaper than the typhoid vaccines now imported from Russia and China. " We manufacture it with facilities having global manufacturing standards. Yet, we have to send these for regular tests at the government run institute, CRI, Kasauli, Himachal Pradesh. Whereas the imported vaccines do not follow such rigorous standards," he pointed out. Dr Kalam on stem cells Stem cells are one of the most fascinating areas of biology today. Stem cells have two important characteristics that distinguish them from other types of cells. First, they are unspecialized cells that renew themselves for long periods through cell division. The second is that under certain physiological or experimental conditions, they can be inducted to become cells with special functions such as the beating cells of the heart muscle or the insulin-producing cells of the pancreas. Research on stem cells is advancing knowledge about how an organism develops from a single cell and how healthy cells replace damaged cells in adult organisms. This promising area of science is also leading scientists to investigate the possibility of cell-based therapies to treat certain diseases. As scientists learn more about stem cells, it may become possible to use the cells not just in cell-based therapies, but also for screening new drugs and toxins and understanding birth defects. It has been hypothesized by scientists that stem cells may, at some point in the future, become the basis for treating diseases such as Parkinson's disease, diabetes, heart disease and brain disorder. A number of experiments over the last several years have raised the possibility that stem cells from one tissue may be able to give rise to cell types of a completely different tissue, a phenomenon known as plasticity. Examples of plasticity include blood cells becoming neurons, liver cells that can be made to produce insulin, and haematopoietic stem cells that can develop into heart muscle. Therefore, exploring the possibility of using adult stem cells for cell based therapies has become a very active area of investigation by researchers. Stem cells, directed to differentiate into specific cell types, offer the possibility of a renewable source of replacement cells and tissues to treat diseases including Parkinson's and Alzheimer's diseases, spinal cord injury, stroke, burns, heart disease, diabetes, and arthritis. In people who suffer from type I diabetes, the cells of the pancreas that normally produce insulin are destroyed by the patient's own immune system. New studies indicate that it may be possible to direct the differentiation of human embryonic stem cells in cell culture to form insulin-producing cells that eventually could be used in transplantation therapy for diabetes. To summarize, the promise of stem cell therapies is an exciting one, but significant technical hurdles remain that will be overcome through years of intensive research. (Excerpts from the inaugural address of President Dr APJ Abdul Kalam at the ASSOCHAM's Knowledge Millennium III meet on the Business of Biotechnology in New Delhi on 23, March 2003) India on good wicket in stem cell research There are six major centers where research on stem cells is done in India. These are the National Center for Biological Sciences, Bangalore, Reliance Life Sciences, Mumbai, the Center for Cellular and Molecular Biology, Hyderabad, the LV Prasad Eye Research Institute, Hyderabad, the Institute of Immunohaematology, Mumbai and the Center for Human Genetics, Bangalore. Stem cell research is picking up in India. According to Dr Rajesh Behl at the Center for Human Genetics, current government guidelines allow generation of stem cells and its export is banned. Making a presentation on the status of stem cell research at the Biotech India 2003 event in New Delhi recently, he said government permits only the use of embryos generated in invitro fertilization (IVF) clinics. Embryonic cells cannot be generated exclusively for stem cell research and researcher could use only supernumerary could be used. Of course, Indian situation is far better than in the US, said top geneticist Dr Craig Venter. Many sects of Christians in the US believe that embryo is a life form the moment conception takes place in the womb. So they are against any tinkering with human life. Because of this top American scientists are moving to Europe to do their research work, he said. Reliance Life Sciences, Mumbai, has one of the world's top facilities for stem cell research. Set up in January 2001 by the $ 13.2 billion (Rs 60,000 crore) Reliance Group, this center has been recognized as one the 11 such centers in the world by the National Institute of Health (NIH), US. This makes it eligible to receive research funds from the US government. The Reliance center is working on development of cell lines from human embryos obtains from human blastocytes. The embryos are received as donations from IVF clinics. Industry welcomes positive budget measures Rajiv Gulati, CMD, Eli Lilly and Company, New Delhi The step of equating biotech sector to the IT sector by allowing them benefits like income tax exemption is laudable. The industry expects the budget will spur R&D due to steps like tax holiday, relaxation of the import duty for the equipment needed for R&D and clinical trials, reduction of GP on the import of R&D equipment to five percent from 55 per cent, IT exemption of the income from R&D. The reduction in customs duty on import of biotech products from 30 to 25 percent is good, although a further reduction to 20 percent was more desirable. Varaprasad Reddy, CMD, Shantha Biotechnics, Hyderabad. The budget has encouraged the biotechnology industry by giving equal status to other knowledge-based industries like IT and Pharma in respect of taxing of export profits. The customs duty exemption on import of capital goods by R&D manufacturing facilities, linked to the export turnover is an encouraging step. The budget has given a boost to equity market by abolishing long-term capital gains tax on equity shares. The introduction of value added tax (VAT) is an encouraging and restructuring exercise. The dividend tax has been again imposed on companies at a higher rate of 12.5 percent, which is not a correct step and is a case of double taxation. The duty on biopharma products has been reduced on certain imported drugs which are also manufactured by Indian companies. Habil Khorakiwala, chairman, Wockhardt, Mumbai. The budget has given the healthcare sector comprising pharmaceuticals, biotechnology and hospitals the industry status for the first time. Enhanced rates of depreciation will not only bring fresh investment but will also benefit modernization of hospitals. The benefit under section 10(23) G will provide access to long-term investment requirement for hospitals and biotechnology. For the first time, Finance Minister Jaswant Singh has put pharmaceutical and biotechnology sectors on par with IT. This is a clear recognition of pharmaceutical and biotechnology sectors not only as a knowledge industry but one with great export potential. He has removed some of the anomalies on import of some R&D equipment and consumables for clinical trials. However, this has been selective on notified items. One would have wished that the finance minister would have extended these exemptions across the board on R&D inputs because in any research project, it is difficult to predetermine the specific inputs. Another disappointment is that royalty and income generated out of R&D in both the domestic and the international markets has not been given adequate consideration. The three lakh rupees limit prescribed may be adequate for an individual but is too insignificant for an organization. My budget rating is nine out of 10 Rana Kapoor, CEO & managing director, Rabo India Finance Ltd, Mumbai. The Union budget has, for the first time, applied a comprehensive approach to the health sectors particularly the pharmaceutical, healthcare and the biotech sector. In so far as the provisions for faster depreciation, exemption from counter veiling duties (CVD), and exemptions from the excise duties on the life saving equipment would provide the stimulus for longer investments in the high-end medical facilities. Biotechnology and pharmaceutical companies will see a drastic increase in the fund allocation by pharmaceutical companies towards R&D . I congratulate the minister for a very positive and growth oriented budget. Biopharma gains a lot from Budget '03 Finance Minister Jaswant Singh has heard the cries of biotech industry for some mercy from high taxes and removal of procedural and regulatory bottlenecks. Here are some of the highlights of Jaswant Singh's announcements which have a positive impact on this industry, particularly the biopharma sector. The customs duty on import of glucometers and glucometer test meters reduced from 10 to five percent. Duty reduced from 25 to five percent on specified life saving drugs Drugs required for clinical trials will be exempt from all duties subject to a license from the Drug Controller of India. Concessional customs duty of five percent extended to all importers of Pharmaceuticals Reference Studies. Specified pharma and biotech equipment for R&D will be exempt from customs duty subject to the fulfillment of some prescribed conditions. Specified life saving drugs and equipment exempted from Excise duty. Excise usually is levied on goods manufactured in the country. Establishment of a central Drug Standard Control Organization to monitor quality, harmonize standards for clinical trials with international benchmarks, speed up new drug approvals and to ensure high standards of safety and efficacy of drugs and pharmaceuticals. Drugs and Cosmetic Rules, 1944 amended to streamline procedures for manufacture and import of new drugs. Some of the important amendments are no institution will be allowed conduct clinical trials for a new drug whether for clinical investigations or for experiments without the permission of the Drug Controller of India. Post marketing surveillance studies have been made mandatory in case of clinical trials for import and manufacture of a new drug The National Seed Policy 2002 has been announced to promote the entry of the private sector to establish R&D facilities for biotech research, increasing seed production in India and marketing of products at the domestic and international level. Biotech industry to be treated on par with IT and telecom in terms of income tax concessions of export profits etc. ]]> <![CDATA[Biotech bay]]> https://biospectrumindia.com/news/95/2908/biotech-bay.html https://biospectrumindia.com/news/95/2908/biotech-bay.html Thu, 10 Apr 2003 16:06:00 +0530 Indian biotech companies have zeroed in on the pharma sector, especially clinical trials, contract research and drug discovery, to tap the tremendous growth opportunities offered by the increasing demand for biotech-based health care products. This has resulted in the emergence of a large number of research and development (R&D) initiatives in the country. This is the reason why it has a major share among new careers and the job seekers are eagerly eyeing the health sector for opportunities. Wockhardt, Reliance Life Sciences, Ranbaxy, Dr. Reddy's Laboratories, Astra Zeneca, Zydus Cadila, Eli Lilly, Pfizer, and Nicholas Piramal are some of the major players in this field. According to biotech industry sources, some 15,000 scientists are employed by the sector nationally. Nearly a third of them are involved in research work. Based on current and future investment prospects, the biopharma sector would require at least 50,000 more researchers in the next five years, majority of them in the contract research services area. On the other hand, the annual output of doctorates ( Ph.Ds) in biosciences and engineering is around 1,500, according to the latest joint industry survey by CII and Rabobank India. Overall, annually India produces around three million graduates. About eight percent or 250,000 are from the disciplines of biosciences and engineering. They are the ones who have the best chance of getting into the biopharma industry. In the last 20 years, India has built an excellent infrastructure, thanks to heavy government funding, in churning out human resources in thousands in classical biotech sectors such as biochemistry, organic chemists, taxonomy, pharmacology and traditional systems of medicine. Indian experts in this field are in great demand abroad. The CII-Rabobank study estimates that approximately 10 percent of the researchers and 15 percent of scientists in Pharma/ Biotech R&D in the US are of Indian origin. The All India Biotech Association (AIBA) Secretary UN Mallik said,"India has developed competence in selected biotechnology areas including diagnostics, therapeutics in health care and pharmaceuticals. Some Indian companies have also teamed up with foreign collaborators for sourcing technology and are experimenting new products produced with the help of foreign technologies. This is with a view to introducing them into the Indian market within the framework of Indian laws." The pharmaceutical market (both biotechnology-based pharmaceuticals and traditional pharmaceuticals) was estimated at $8 billion and is expected to grow to $37 billion by 2010. There are approximately 250 large, research-based pharmaceutical companies in India, with as many as 3000 companies active in pharmaceutical (particularly generics) manufacturing. The industry employs approximately 460, 000 and is the world's fifth-largest producer of medications by volume. The Indian biotechnology industry is ranked third in the world in terms of stem cell research, primarily because both the government and private industry have invested heavily in research institutes studying human disease and searching for treatments. Today the biopharmaceutical business includes contract research and manufacturing services, clinical research including therapeutical vaccines and stem cell researches. "Biopharma is indeed a developing market and is expected to grow significantly over next 10 years. However, issues like GMP (good manufacturing practices) and related regulatory aspects are still little blurry because of insufficient guidelines," says Dr Kulvinder Singh Saini , director of biotechnology and bioinformatics, Ranbaxy, New Delhi. Pharma companies spend $300-500 million ( Rs 1,500-2,500 crore) for developing a new drug. Three fourths of this cost is accounted for by expenses on clinical research and evaluation. Also the pharma companies in the US have recognized that they cannot do all the research by themselves. And the latest trend in the American market is partnering of pharma companies with niche biotech players focusing on highly specialized domains. These companies have realized that the labor costs are comparatively low (almost a tenth of their own). Thus this field provides tremendous job opportunities for the large number of job seekers in India. Take the case of Mumbai-based Wockhardt. This company was ranked 24 among the largest value creator across all companies and industries in India by a premier business magazine. And the company is making a lot of efforts to upgrade the profile of its employees. A new initiative, in collaboration with the London College of Management, UK, has been launched in the company. More than 300 Wockhardians in sales and marketing, have enrolled in a three-year MBA program. Wockhardt has also made available scholarships to performing Wockhardians. The company has invested over 50,000 man-hours in training and development of its staff in 2001. Almost 1800 employees out of the total staff strength of 2700 of Wockhardt undertook the training in 2001. The University of Pune has already recognized the importance of biopharma and has started several courses in the university last year. These include: MBA (biotechnology), M.Sc.(pharamceutical chemistry), M.Sc.(bioinformatics), B.Sc.(biotechnology), B.Sc.(applied) biotechnology - one year's course after B.Sc. "We are also starting integrated five year M.Sc. / M.Tech., in bioinformatics and biotechnology. M.Sc. degree will be given to those who complete five years of successful training after 12th and M.Tech., degree will be given in addition to M.Sc. if the students continue for the sixth year. We have also established major interaction with the companies such as Emcure, Frontier Tech. Serum Research Inst. etc." says Ashok Kolaskar, vice chancellor, University of Pune. "Over the next five to seven years, it is expected that the ongoing efforts of R&D institutions and Indian biotech industry would contribute substantially to import substitution, augmentation of local production and introduction of some new products for global marketing. This will be in the areas such as diagnostics, vaccines, therapeutics, pharmacogenomics as well as bioinformatics, agricultural biotechnology, industrial biotechnology etc. The major strength of India are low operational cost, government initiatives to develop biotech parks and a world-class infrastructure, the government support for start-ups and early-phase companies, excellent R&D infrastructure and an established pharmaceutical industry. In view of the above information, we feel that there is going to be big contribution by the biopharma sector towards career opportunities for young generation students and researchers in biotechnology" emphasized UN Mallik, secretary of AIBA Biotechnology includes a variety of industries, but pharmaceutical drug discovery is one of its most significant facets. The biotech and pharmaceutical industries offer a more stable and better-paying alternative. This biotech bay gives hope for a broad range of job seekers interested in science. ]]> <![CDATA[Reader of the 'Book of Life']]> https://biospectrumindia.com/news/95/6098/reader-of-the-book-of-life.html https://biospectrumindia.com/news/95/6098/reader-of-the-book-of-life.html Thu, 10 Apr 2003 13:04:00 +0530 In 2000, he lost narrowly to the then US president-elect, George W Bush, the title "The Time Man of the Year." But Dr Craig J Venter's influence will go beyond the immediate happenings of our life. For, called "Gene Mapper", by the Time magazine, his scientific work in completing the mapping of the human genome is an attempt to read the secrets of the humanity itself. This 56-year-old biochemist from University of California, San Diego, and then the chief of Celera Genomics, may have shared the fame with a government scientist Francis Collins when they shared the podium at the White House in June 2000 to announce their simultaneous mapping of the human genome. But the world knew it was Venter's "shotgun sequencing method" that made it all possible. One of the most cited biologists of modern times, Craig J Venter was in New Delhi in March to speak at the Millennium Summit -III organized by ASSOCHAM. In an interview with Executive Editor N Suresh, Venter unraveled some of the secrets of human genome " You are not what your genes are" What is the progress in the identification of the functions of human genes? From the genome mapping, we have concluded that humans have only about 30,000 genes and not 140,000 or so as it was thought by scientists earlier. Now efforts are on to determine the functions of each of these genes. We know all about some 9,000 genes. We know some of the functions of some 5000 genes. We don't know anything about the remaining 42 per cent of the genes. For each species, for each set of genes, there is a precise set of environmental conditions that impact them. You are certainly not what your genes are. When we are studying the genetic code, we are only studying at best half the question. Humans have 100 trillion cells and they work together in mass with genes. So it will be some time before we even understand the basic functions, let alone how all of them interact effectively with the environment. Where does this leave the theory of genetic determinism which has been popular for decades? Each human has roughly two to three million of genetic code that are different from another person. But most of these codes probably have no biological significance whatsoever. They may have just some forensic and tracking applications, and maybe useful as mapping tools. Less than a percent of these codes occur in genes or regulatory regions. This means that at the biological level, at the gene level, we are all virtually identical twins. This clearly means that your life not determined by your genes. The fraction that is really different in a biological and meaningful way is such a tiny percentage it is stunning. The smaller number of genes and the similarity of human genes to that of a mouse hopefully put the nail in the coffin of the genetic determinants. What is the next big thing after the genome mapping? We have some 100 trillion cells in each of our bodies. This all interact with each other in many complex ways and produce a variety of proteins. With the information about the human gene sequence, it is possible now to measure these proteins. Because we can get at every protein in the genome. For the known useful genes of around 50,000 there are some 200,000 to one million proteins. We are building a large-scale protein facility to do roughly one million protein sequences per day. We are looking at using these proteins as markers for specific diseases. The genome is important because with mass spectroscopy sequencing, the proteins get blown apart into small fragments and we can compare those sequences back with databases. Till now most of these did not match anything on the databases and so interpretation was difficult. Now every one of these will have a match and we can rapidly determine the sequence of the proteins in the cells and in the blood. Does genomic information provide clues to our past? Many scientists believe that evolution is adding on genetic information and adding on complexity. But we find that most human pathogens probably started from a much more complex organism and threw out genetic material during evolution. We tried to find out whether we could come out with a molecular definition of life. To test this we knocked out 200 or so genes from Mycoplasma pneumoniae and observed whether we still have a living organism. And with Mycoplasma genitalium (a small microbe found in the human genital area) we asked the question whether all its genes were necessary for life. And we found that the 200 extra genes in pneumoniae were completely dispensable and about 200 genes in genitalium too appeared dispensable. We found out three stunning things. First of the 300-odd genes, 103 were completely new to science. We think we know a lot about biology, yet in this most minimal cell, we had no idea about what one third of the genes do, except that if we knock them out, the cell dies. Two, we could not come up with a molecular definition of life. We found that life is context-sensitive, that is, the environment that the cell is in is equally important to any component of the genetic code. Third, the Darwinian evolution wasn't just random errors in the genetic code. With haeomphilus and every pathogen we have worked on, we found there was preprogramming in the genetic code to cause change in the structure of specific genes. Essentially a pathogen fools the immune system of its host. And each pathogen has a different way of doing it. Essentially, the human genome contains a molecular clock as repeated sequences of letters between genes and mutates over time. Measuring the rate of these changes would some day allow us to predict the time at which it happened. This may help to pinpoint the epoch in which the traits that make us unique humans emerged. You have been talking about the development of personalized medicine. What are these? With the human genetic code, we find roughly two to three million variations in the chromosomes. We have about 2.8 million well characterized, so called snips (single nucleotide polymophisms) in our database that are now being used by scientists around the world to study linkage to disease. For the first time, we can look at this genetic variation by chromosome. For example, you can discover genetic variation in the genome of individuals who have an increased risk of myocardial infarction. Scientists are using this information to find linkage to disease. The pharma industry is using this to find ways to improve clinical trials and drug effects. This leads to the development of personalized medicine. Recently, there was a type II diabetes drug that had to be taken off the shelves because one out of 10,000 people had a severe liver toxicity to this drug. If we can find simple tests that predict toxicity, it will have a huge impact. Most drugs work only on 30 to 50 percent of the population but are given to everybody because in theory they are relatively safe and doctors work on the principle that it is easier to give it everybody than find out whose disease it can actually cure. Personalized medicine would actually try to treat the patient and not kill him inadvertently. What is the uniqueness of your 'shotgun sequencing' method? All the sequencing technologies give us only 500 to 600 letters of genetic code. So how do you get the genetic code of something billions of letters long. The other problem is that genomes, including the human genome, have lots of repeats. The same sequence is repeated over and over again. In one method, scientists would sequence one piece, get 600 letters, make a little primer to read the next set of 600 letters and work sequentially down the clone with that. By this method, it would take 100 years to sequence the human genome. In the second method, genes of the first clone are mapped, then lined up and sequenced. This way, it took three years to just arrange the E.coli clones before sequencing could be done. With 'whole genome shotgun", we don't do any cloning first. We take the entire set of chomosomes, break those down into little pieces and use mathematical algorithms to try and solve the big jigsaw puzzles. Why is it important to study mouse genome and not that of chimpanzees? Studies show that the human and mouse genomes are almost identical genetically. This enhances the chances of predicting the regulatory regions in the genome and we will have comparative genomic studies. On the other hand, data generated at Max Planck Institute using the human genome data indicates that the difference between the two is just 1.27 percent in genome sequences. So it is better to study the mouse genome which evolved 100 million years ago and it will provide a better comparison on the evolutionary changes that had taken place. We have to look closely at our own evolution and that of vertebrae. From the simple drosophila (fruit fly) to humans, the evolution has taken place in about 600 million years. And just four to five gene groups only expanded in this period. For example, humans have an immune system, while the fruit fly doesn't have a significant immune system. All the genes associated with our immune system expanded during this period. When we compare with homeostasis, all things associated with our vascular system expanded during this period. But we have virtually identical gene set with mice and other vertebrates. The key to our uniqueness are things like the transcription pattern in gene regulation, that turn on different sets of response to environmental conditions. Among all human chromosome, the chromosome 19 has the largest number of genes. Because it has neurotransmitter receptors, olfactory receptors and transcription factors. In the future, we will be able to provide a date in some cases of species, where this evolutionary event took place. What is your work related to synthetic cells? We are now trying to develop a synthetic cell just to see how many essential genes are required to form a living thing. For example, mycoplasma lives on glucose or fructose. If you knock out the glucose transporter gene and you have both sugars in the environment, the cell will happily live. But if you only have glucose in the environment and you knock out the glucose transporter gene, the cell dies. So for each species, for each set of genes, there is a precise set of environmental conditions or a broad range of them. Can you explain your work related to the use of microbes in the energy field? There is a microbe, Methanococcus jannschii, which is totally frozen at human body temperature. It comes to life at 65 degrees Celsius and its optimum growth takes place at 85 deg. C. And it is very happy to live in boiling water. It uses just two sources for its metabolism: carbon dioxide for carbon and hydrogen as an energy source. This organism was found in the underwater thermal springs in the Pacific Ocean. We are trying to sequence its genetic code and see if it could be used to produce the organisms in large numbers . If that happens, it could be used to remove pollution by letting it use of all the waste carbon dioxide from industrial processes and also fix hydrogen, a clean fuel, directly from the atmosphere. Should patenting of genes be allowed? I think there should be a very high bar on patents on genes. Just a patent on genes alone is not enough. You need to know something about what the gene does that has a real purpose of going into to do something about medicine. Incyte has filed thousands of patents on genes but these are worthless because most these genes don't seem to have any useful function. Most genes have multiple proteins and multiple functions and unless this information is available, it is junk. Do you support genetically modified foods? We have to be very careful about things which have transfer of genes between organisms. We have to study the stability of the genes in the new environment not just the beneficial effects. Most of the lateral transfer of genes in the environment has taken place in nearby areas. Unfortunately, these issues are not discussed in the polarized environment existing on this issue. I have no reservations about the science. But I don't think all the questions that need to be asked have been asked. There are no intelligent discussions on this. Honestly, I feel that the benefits far outweigh the risks with GM foods. In which areas of biotechnology should India invest? The best investment is to improve the quality of education and research work. Keep Inder Vermas (a well know geneticists at Salk Institute, USA) in India itself."India needs to improve the quality of education and research work"What is the progress in the identification of the functions of human genes? From the genome mapping, we have concluded that humans have only about 30,000 genes and not 140,000 or so as it was thought by scientists earlier. Now efforts are on to determine the functions of each of these genes. We know all about some 9,000 genes. We know some of the functions of some 5000 genes. We don't know anything about the remaining 42 per cent of the genes. For each species, for each set of genes, there is a precise set of environmental conditions that impact them. You are certainly not what your genes are. When we are studying the genetic code, we are only studying at best half the question. Humans have 100 trillion cells and they work together in mass with genes. So it will be some time before we even understand the basic functions, let alone how all of them interact effectively with the environment. Where does this leave the theory of genetic determinism which has been popular for decades? Each human has roughly two to three million of genetic code that are different from another person. But most of these codes probably have no biological significance whatsoever. They may have just some forensic and tracking applications, and maybe useful as mapping tools. Less than a percent of these codes occur in genes or regulatory regions. This means that at the biological level, at the gene level, we are all virtually identical twins. This clearly means that your life not determined by your genes. The fraction that is really different in a biological and meaningful way is such a tiny percentage it is stunning. The smaller number of genes and the similarity of human genes to that of a mouse hopefully put the nail in the coffin of the genetic determinants. What is the next big thing after the genome mapping? We have some 100 trillion cells in each of our bodies. This all interact with each other in many complex ways and produce a variety of proteins. With the information about the human gene sequence, it is possible now to measure these proteins. Because we can get at every protein in the genome. For the known useful genes of around 50,000 there are some 200,000 to one million proteins. We are building a large-scale protein facility to do roughly one million protein sequences per day. We are looking at using these proteins as markers for specific diseases. The genome is important because with mass spectroscopy sequencing, the proteins get blown apart into small fragments and we can compare those sequences back with databases. Till now most of these did not match anything on the databases and so interpretation was difficult. Now every one of these will have a match and we can rapidly determine the sequence of the proteins in the cells and in the blood. Does genomic information provide clues to our past? Many scientists believe that evolution is adding on genetic information and adding on complexity. But we find that most human pathogens probably started from a much more complex organism and threw out genetic material during evolution. We tried to find out whether we could come out with a molecular definition of life. To test this we knocked out 200 or so genes from Mycoplasma pneumoniae and observed whether we still have a living organism. And with Mycoplasma genitalium (a small microbe found in the human genital area) we asked the question whether all its genes were necessary for life. And we found that the 200 extra genes in pneumoniae were completely dispensable and about 200 genes in genitalium too appeared dispensable. We found out three stunning things. First of the 300-odd genes, 103 were completely new to science. We think we know a lot about biology, yet in this most minimal cell, we had no idea about what one third of the genes do, except that if we knock them out, the cell dies. Two, we could not come up with a molecular definition of life. We found that life is context-sensitive, that is, the environment that the cell is in is equally important to any component of the genetic code. Third, the Darwinian evolution wasn't just random errors in the genetic code. With haeomphilus and every pathogen we have worked on, we found there was preprogramming in the genetic code to cause change in the structure of specific genes. Essentially a pathogen fools the immune system of its host. And each pathogen has a different way of doing it. Essentially, the human genome contains a molecular clock as repeated sequences of letters between genes and mutates over time. Measuring the rate of these changes would some day allow us to predict the time at which it happened. This may help to pinpoint the epoch in which the traits that make us unique humans emerged. You have been talking about the development of personalized medicine. What are these? With the human genetic code, we find roughly two to three million variations in the chromosomes. We have about 2.8 million well characterized, so called snips (single nucleotide polymophisms) in our database that are now being used by scientists around the world to study linkage to disease. For the first time, we can look at this genetic variation by chromosome. For example, you can discover genetic variation in the genome of individuals who have an increased risk of myocardial infarction. Scientists are using this information to find linkage to disease. The pharma industry is using this to find ways to improve clinical trials and drug effects. This leads to the development of personalized medicine. Recently, there was a type II diabetes drug that had to be taken off the shelves because one out of 10,000 people had a severe liver toxicity to this drug. If we can find simple tests that predict toxicity, it will have a huge impact. Most drugs work only on 30 to 50 percent of the population but are given to everybody because in theory they are relatively safe and doctors work on the principle that it is easier to give it everybody than find out whose disease it can actually cure. Personalized medicine would actually try to treat the patient and not kill him inadvertently. What is the uniqueness of your 'shotgun sequencing' method? All the sequencing technologies give us only 500 to 600 letters of genetic code. So how do you get the genetic code of something billions of letters long. The other problem is that genomes, including the human genome, have lots of repeats. The same sequence is repeated over and over again. In one method, scientists would sequence one piece, get 600 letters, make a little primer to read the next set of 600 letters and work sequentially down the clone with that. By this method, it would take 100 years to sequence the human genome. In the second method, genes of the first clone are mapped, then lined up and sequenced. This way, it took three years to just arrange the E.coli clones before sequencing could be done. With 'whole genome shotgun", we don't do any cloning first. We take the entire set of chomosomes, break those down into little pieces and use mathematical algorithms to try and solve the big jigsaw puzzles. Why is it important to study mouse genome and not that of chimpanzees? Studies show that the human and mouse genomes are almost identical genetically. This enhances the chances of predicting the regulatory regions in the genome and we will have comparative genomic studies. On the other hand, data generated at Max Planck Institute using the human genome data indicates that the difference between the two is just 1.27 percent in genome sequences. So it is better to study the mouse genome which evolved 100 million years ago and it will provide a better comparison on the evolutionary changes that had taken place. We have to look closely at our own evolution and that of vertebrae. From the simple drosophila (fruit fly) to humans, the evolution has taken place in about 600 million years. And just four to five gene groups only expanded in this period. For example, humans have an immune system, while the fruit fly doesn't have a significant immune system. All the genes associated with our immune system expanded during this period. When we compare with homeostasis, all things associated with our vascular system expanded during this period. But we have virtually identical gene set with mice and other vertebrates. The key to our uniqueness are things like the transcription pattern in gene regulation, that turn on different sets of response to environmental conditions. Among all human chromosome, the chromosome 19 has the largest number of genes. Because it has neurotransmitter receptors, olfactory receptors and transcription factors. In the future, we will be able to provide a date in some cases of species, where this evolutionary event took place. What is your work related to synthetic cells? We are now trying to develop a synthetic cell just to see how many essential genes are required to form a living thing. For example, mycoplasma lives on glucose or fructose. If you knock out the glucose transporter gene and you have both sugars in the environment, the cell will happily live. But if you only have glucose in the environment and you knock out the glucose transporter gene, the cell dies. So for each species, for each set of genes, there is a precise set of environmental conditions or a broad range of them. Can you explain your work related to the use of microbes in the energy field? There is a microbe, Methanococcus jannschii, which is totally frozen at human body temperature. It comes to life at 65 degrees Celsius and its optimum growth takes place at 85 deg. C. And it is very happy to live in boiling water. It uses just two sources for its metabolism: carbon dioxide for carbon and hydrogen as an energy source. This organism was found in the underwater thermal springs in the Pacific Ocean. We are trying to sequence its genetic code and see if it could be used to produce the organisms in large numbers . If that happens, it could be used to remove pollution by letting it use of all the waste carbon dioxide from industrial processes and also fix hydrogen, a clean fuel, directly from the atmosphere. Should patenting of genes be allowed? I think there should be a very high bar on patents on genes. Just a patent on genes alone is not enough. You need to know something about what the gene does that has a real purpose of going into to do something about medicine. Incyte has filed thousands of patents on genes but these are worthless because most these genes don't seem to have any useful function. Most genes have multiple proteins and multiple functions and unless this information is available, it is junk. Do you support genetically modified foods? We have to be very careful about things which have transfer of genes between organisms. We have to study the stability of the genes in the new environment not just the beneficial effects. Most of the lateral transfer of genes in the environment has taken place in nearby areas. Unfortunately, these issues are not discussed in the polarized environment existing on this issue. I have no reservations about the science. But I don't think all the questions that need to be asked have been asked. There are no intelligent discussions on this. Honestly, I feel that the benefits far outweigh the risks with GM foods. In which areas of biotechnology should India invest? The best investment is to improve the quality of education and research work. Keep Inder Vermas (a well know geneticists at Salk Institute, USA) in India itself. ]]> <![CDATA[Biotech bug bites Ranbaxy]]> https://biospectrumindia.com/news/95/1140/biotech-bug-bites-ranbaxy.html https://biospectrumindia.com/news/95/1140/biotech-bug-bites-ranbaxy.html Thu, 10 Apr 2003 12:38:00 +0530 The company had identified biotech as a new area of investment in 2001. For, the worldover, pharma companies are betting on biotech to give them new drugs. So in 2002 it set up of an exclusive biotech research lab at the company's R&D center at Gurgaon (Haryana) near New Delhi. The company's R&D center is set amidst 17 acres of land, with a covered area of over 20,000 sq. mt. and is one of the largest R&D facilities in India. Dr Kulvinder Saini is heading a 15-member team of scientists in this lab. At present, the core competence of the lab lies in the development and commercialization of generic active pharmaceutical ingredients (API) and bio-equivalent dosage forms in line with international regulatory and quality requirements. The company has committed R&D investments to the tune of $50-60 million (Rs 300 crore) this year. The company is on the lookout for research alliances in biotechnology and has identified medicinal and process chemistry, biological screening, pre-clinical development, and early clinical development as its main areas of focus. In biotech research, the company envisages forming committed alliances, co-marketing as well as exploring in-licensing agreements with other global pharma and biotech companies. According to company officials, Ranbaxy provides a perfect platform for biotech research as it already has the expertise in multiple disciplines that will provide the crucial inputs that are key to success. These include medicinal chemistry, pharmacology, pharmacokinetics, bioanalysis and toxicology, process R&D, patents, medical and commercial inputs, high throughput screening, target protein production and so on. Company officials say that Ranbaxy's foray into biotechnology will go a long way in the enhancement of early drug discovery. The company is also looking at partners in this area."Partnering with Ranbaxy for biotech research can provide cost-effective drug discovery, speedy candidate selection, diversity in formulation development and platform technology in the area of oral controlled release delivery systems, efficient pre-clinical development and early clinical development," said the official. It's continued focus on R&D has resulted in several approvals in developed markets and significant progress in NDDR. The Company has already filed four IND (Investigational New Drug) applications with the Drugs Controller General of India (DCI) and has an active NCE pipeline. Its first NCE RBx 2258, for BPH has been licensed to Schwarz Pharma AG of Germany, to develop, market and distribute the product in USA, Japan and Europe, while the company has retained the rights for all other markets. Ranbaxy's anti-asthma molecule, RBx 7796 (Clafrinast) is in phase I clinical trials in India. The company is awaiting approvals to conduct phase 1 clinical trials for RBx 7644 (Ranbezolid), an extended spectrum Oxazolidinone from the DCI for both its oral and intravenous usage in India. RBx 7644 (Ranbezolid) is presently undergoing phase I clinical trials in the UK. Ranbaxy also has three molecules in the late discovery stage and one in pre-clinical. The company's major research focus is in the areas of anti-infectives, urology, respiratory, anti-inflammatory, metabolic disorders and anti-cancer segments. Ranbaxy's first NDDS (New Drug Discovery Research) innovation once a day Ciprofloxacin has been licensed to Bayer AG, the originators for select markets. Ranbaxy has filed two new drug applications (NDAs) in the US for Metformin syrup and Ofloxacin tablets. Ranbaxy's NDDS focus will be in developing prescription products and value added dosage forms and expand its platform technologies. Ranbaxy's president (R&D) Dr Rashmi Barbhaiya was confident about the new market. "Ranbaxy and India have tremendous opportunities to create a big success in pharmaceuticals, particularly in new drug discovery. This is going to require an enhanced driving force for innovation and will require vital investment and alliance building, both within the industry and with the government." The target to achieve $ 1 billion sales by 2004 in line with its vision and to maintain a robust growth post 2005. To translate these objectives and to optimize value creation, the Ranbaxy has adopted a multi-pronged strategy. Ranbaxy is making a transition from a generic company to a specialty pharmaceutical company with an ultimate intent of transforming into a research-based organization. It manufactures and markets branded generic pharmaceuticals and active pharmaceutical ingredients. The company's products are sold in over 70 countries with its manufacturing operations in seven countries and a ground presence in 25 countries. It has employed diverse strategies, including exports, alliances, partnerships and acquisitions to gain the flexibility needed for viable and profitable business operations worldwide. Dr Barbhaiya said the company has few priorities such as to improve the probability of success, building robust R&D organization by channeling the energy of the teams into right direction. Emphasizing on the strength of Indian Pharma industry he said, "The Indian industry is full of young talent. The only concern is to motivate them to work in the country and check the brain-drain." Apart from this he added that the cost effectiveness in the Indian market is also play key role to attract the corporates to invest here. "Geonomics,proteonomics pharmacogeonomics are among the emerging areas of biotech research in India. There are preliminary guidelines established by the government for working on recombinant plants and microorganisms. However, regarding medical biotech research, there is an urgent need for policy formulation especially for pharma sector. This will actually solve a lot of problems for us and it should happen soon otherwise we will loose time." Suggesting his views to improve the regulatory front for research and business, he said, "There should be single entry, regulatory system should be based on telecom model for biotech and genomic research. There is also a need for strong industry academia interaction as well as involving public bodies and NGOs for policy making." Ranbaxy had global sales worth $ 764 million( Rs 3,710 crore) with a growth rate of 39 percent .Overseas markets accounted for 72 percent of the sales. The major contributors were USA, Brazil, UK and other emerging markets. Faiz Askari ]]> <![CDATA[Set to grow ten times]]> https://biospectrumindia.com/news/95/1566/set-to-grow-ten-times.html https://biospectrumindia.com/news/95/1566/set-to-grow-ten-times.html Thu, 10 Apr 2003 11:46:00 +0530 Indian biotechnology sector is currently nascent and accounts for a mere one percent of the global biotechnology market. However, it is poised for an exponential growth over the next five years with an expected global market share of 10 percent. The market for modern biotechnology products and services in India is estimated to be about $150 million (Rs 750 crore) for the year 2002, of which about 40 percent ($60 million) are estimated to be export revenues. The consumption of biotech products in India is estimated to grow 10-fold to $1.5 billion (Rs 7,500 crore) and to $4.5 billion by 2010. The key markets for Indian biotechnology sector includes industrial biotech (enzymes), vaccines (recombinant Hepatitis B etc.), diagnostics, veterinary products, agri biotech products (genetically modified seeds). The industry comprises mainly of pure biotechnology startups and large established companies in pharmaceuticals, agriculutre, and information technology. Market leaders in this industry are Shantha Biotechnics, Biocon, Bharat Biotech, Wockhardt, Dr Reddy's Laboratories, Serum Institute of India, Zydus Cadila, Aventis Pharma, Rhein Biotech, and Reliance Life Sciences. Over the last two decades, India has developed an adequate infrastructure and trained manpower in modern as well as classical biotechnology, mainly due to active support of the Department of Biotechnology (DBT). Since its inception, the DBT has made concerted efforts towards capacity building in human resources and infrastructure for research and development. As a result, currently India can boast of about 200 government laboratories and several private research institutions, with state-of-the-art equipment and facilities for modern biotechnology research. These institutions have been quite active in transferring technology to industry for scale-up, validation and commercialization. The government's budgetary allocation to biotechnology has more than trebled from $ 150 million in 1987-88 to $ 300 million in 1997-98 and $ 500 million in 2002-03. To promote private sector efforts in biotech research, the national budget of 2002-03 has provided for 150 percent tax deduction for R & D spending on biotechnology. Indian companies enjoy certain advantages in the area of biotechnology such as low operational costs, low cost technologies, skilled human resource base, large network of research laboratories and abundance of raw materials in the form of plant, animal and human genetic diversity. Recently, several state governments such as Maharashtra, Andhra Pradesh, and Karnataka have formulate Biotechnology Policies with focus on setting up Biotech Parks, Incubators, Centers of Biotech Excellence and providing fiscal incentives to the investors. Global Biotech Industry Based on the industry estimated, there are about 1,457 biotechnology companies in the United States in 2001, representing a growth of 20 percent since 1992. The majority of biotechnology companaies in US ( about 76 percent) are either privately owned or are divisions, subsidiaries or joint ventures and only 350 biotech companies ( about 24 percent) are publicly traded in the US stock exchanges with estimated market capitalization of $ 331 billion. The size of the US biotech industry has more than trebled since 1992, with revenues increasing from $ 8 billion in 1992 to $ 28 billion in 2001. The number of employees working for biotechnology companies have also increased by almost 100,000 from 79,000 in 1992. The biotechnology industry in the US is highly concentrated with predominant presence in nine metropolitan areas, which are classified as leading Biotechnology Centers (or Industry Clusters) of US. These biotech centers account for more than three-fifths of all the National Institute of Health spending on research and for slightly less than two-thirds of all biotechnology related patents. Biotechnology commercialization is even more concentrated within these centers; more than three-fourths of all biotech firms with 100 or more employees and those firms founded in the past decade are in one of these nine centers. The same centers account for eight of every nine dollars spent in venture capital for biopharmaceuticlas and for 95 percent of the dollars in research alliances. The majority of US biotechnology firms are pursuing human healthcare market. The human health care market can be broadly classified into five categories-therapeutics, diagnostics, immunology, drug delivery systems, and vaccines. A study by the Institute for Biotechnology Information (IBI), North Carolina, estimates that about 33 percent of the US biotechnology companies are working in the area of human therapeutics while another 19 percent are pursuing diagnostics as their key activity. In the last two decades (1982 to 2001), the US FDA approved 132 biotechnology drugs for medical usage, developed by biotechnology and pharmaceutical companies. The US is the leading exporter of agricultural products and has embraced agricultural biotechnology to maintain its leadership in food production. Worldwide, about 271 million hectares (Mha)of land are under cultivation, of which 19.4 percent ( 53 Mha) consisted of GM crops in 2001, grown by 5.5 million farmers. Between 1996 and 2001, global area of transgenic crops increased more than 30-fold, from 1.7 Mha in 1996 to 53 Mha in 2001. In 2001, four principal countries grew 99 percent of the global transgenic crop area. The US is the world leader in transgenic crops, accounting for over two-thirds of all transgenic crops planted worldwide. Other three major producers of GM crops are Argentina( 22 percent), Canada ( 6 percent) and China ( 3 percent). Global Biotech Financing Biotechnology businesses, just like biopharmaceuticals companies, can operate using a diverse range of business models and early-stage funding mechanisms. A biotech venture can be potentially financed by a wide range of alternative sources such as angel funding (personal savings, friends & family), banks (for capital expenditure and working capital), government grants, university seed funds, general or specialist venture capitalists, investment banks and capital markets. Notwithstanding the traditional market cycles, the biotechnology sector witnessed a boom in the capital raised throughout the 1990s. The most important market trend was the growth in the size of the funds and the average amount of money available to each fund manager. For instance, whereas a typical biotechnology-specialized fund in the 1980s was measured in the tens of millions of dollars, an equivalent fund today is 10-20 times larger. The biotechnology sector raised $ 14.7 billion (excluding payments, fees and revenues from corporte partnerships) in 2001, which is substantially more than any other year in the sector's history (with the exception of $ 31.5 billion raised in 2000). However, public offerings, both initial and follow-on, did not play a prominent role as they accounted for a mere 24 percent of all new financing in 2001. In 2000, public offerings, both initial and follow-on, accounted for 59 percent of all money raised. Private investors supplied the rest. Venture capital concerns, institutional investors, corporate funds and the like poured more than $ 11 billion into biotech firms ( both private and publicly held) over the course of the year, amounting to 76 percent of the total raised. The biotech IPO market was quite tepid in 2001, but a handful of companies did manage to come public, all being at lower valuations than those achieved by most companies in 2000. Ten biotech-related firms completed IPOs in 2001- six in the US, two in Canada, one in Germany and one in Australia, raising a combined $ 434 million. The emergence of corporate venture capital funds (VCs) is the latest trend in the global biotech industry. With an eye to the future, large pharmaceuticals multinationals have created venture capital arms to invest in startups-and they invest early, long before these startups are even mature enough to sign a partnering deal. Since January 2001, the Novartis Venture Fund and the Novartis BioVenture Fund together have invested in 18 startups; GlaxoSmithKline's affliliates SR Ltd., one, and Euclid SR Partners have put money into 13; Johnson & Johnson Development Corp. has invested in 12; Novo Nordisk's investment arm Nov A/S has contributed funds to nine; and BD Ventures LLC (Becton, Dickinson and Co's venture fund) has invested in four fledgling firms. This report is an extract from the Executive Summary of the CII-Rabo India Joint report on financing biotech enterprises. The full report, a priced publication is available with both the organizations. The contact persons are Dr Sandhya Tewari (ciico@ciionline.org) or Alok Gupta (alok.gupta@rabobank.com) Peptimmune gets $41.2 million VC funds Biopharma drug maker, Peptimmune, Inc. has secured $ 41.2 million in a first round of venture capital financing to accelerate the development of specific targeted immunotherapeutics for the treatment of a broad range of autoimmune disorders. A company press release said the investment was co-led by New Enterprise and MPM Capital, with additional funding from Prism Venture Partners, Vanguard Ventures, Hunt Ventures LP., and Boston Medical Investors, Inc. Peptimmune, based in Cambridge, holds exclusive worldwide licenses or options to one issued US patent and 32 applications. Peptimmune has four product candidates in late stage preclinical development and research. Its lead product is an immunotherapeutic specifically targeted to treat pemphigus vulgaris, an autoimmune disorder of the skin, for which Peptimmune anticipates entering Phase I human clinical trials this year. Each of Peptimmune's drug candidates is designed to selectively inhibit harmful immune responses without compromising normal immune function and each product represents a distinct therapeutic approach. If successful in the initial clinical indication, an opportunity for new therapeutics will arise for diseases, such as multiple sclerosis (MS), rheumatoid arthritis, Type 1 diabetes, myasthenia gravis, and lupus erythematosus. Peptimmune's lead product is an injectible immunotherapeutic designed for pemphigus vulgaris (PV), an autoimmune disease that results in life- threatening blisters of the skin and mucous membranes. PV is a rare disease, which affects several thousand individuals in the United States. PV arises from an inappropriate immune response of the body to desmoglein 3, a protein that holds skin cells together in normal, healthy skin. Peptimmune has identified a specific peptide epitope of desmoglein 3 and has formulated it to induce tolerance in the patient and reduce or eliminate the harmful immune response. Peptimmune expects to file an IND and begin a Phase I clinical study for this drug candidate later this year. The company has three additional product candidates: Cathespin S inhibitor: a small molecule for the treatment of a variety of autoimmune diseases. The inhibitor suppresses a specific process in autoimmune and allergic diseases. Peptimmune has partnered with Medivir, a Swedish biotechnology company, to develop this drug candidate. Random Amino Acid Copolymer: a peptide treatment for MS that works by a similar mechanism as Copaxone (R), an approved and marketed MS drug. The new copolymer promises to have superior clinical advantage. Soluble MHC Class II/Ig Fusion Proteins: proteins designed to deactivate disease-specific immune responses by acting as molecular decoys for disease-inducing immune cells. Peptimmune was established as an independent company by Genzyme Corp. in January 2002. Genzyme provided initial capitalization for Peptimmune by purchasing $5.5 million in shares of preferred stock and holds a right of first offer to participate in the commercialization of the peptide therapy for pemphigus vulgaris. The new investment in Peptimmune will reduce Genzyme's ownership interest in the company to approximately 10 percent. IndiGene to invest $10 million in India The US-based IndiGene Pharmaceuticals, engaged in the development of superior plant based medicines, will be investing $10 million in India to set up a development center at Hyderabad. The center will support product development, supply logistics and manufacturing, from mid-2003. The release quoting M Vaman Rao, CEO, IndiGene said, "our aim is to rapidly develop and deliver quality prescription and OTC products for the global market and reduce the development risk, cost and time to market. We achieve this goal by scientifically validating and optimizing the therapeutic efficacy of selected plant-derived natural molecular compositions." " Recent changes in the regulatory policy guidelines in the US Food and Drug Administration now support the commercial development of plant-derived molecular composition medicines, " said Vaman Rao. IndiGene intends to forge partnerships in the areas of product development, manufacturing and distribution with leading pharma companies. " We are not a contract research organization and intend to develop the drugs and then out-license to pharma companies for further development and commercialization," Vaman Rao said. The release also noted that the company already has a sustainable product development pipeline and is focusing on four therapeutic areas-metabolic disorders, oncology, central nervous system and infections. Within these, it concentrates on Parkinson's disease, HIV, diabetes and hepatitis B. The company has patented a breakthrough rapid drug development process under which multiple molecules can be used for drug development. The release reported that the combined worldwide market for both plant-derived prescription and OTC products of IndiGene is estimated to cross $ 100 billion by 2010. Biogenus to invest $20 million in Karnataka Biogenus India Ltd, the Indian arm of US-based biotechnology firm Biogenus Inc, has signed a memorandum of understanding (MoU) with the Karnataka government to set up a marine biotech research station and a bacterial culture and enzymes plant in the state. The joint venture envisages an investment of around $20 million (Rs 100 crore) in the state. The marine research center would be set up at the Marine Biotech Park in Uttara Kannada district and the manufacturing plant would be in Bangalore. "Our main focus is on areas like aquatic biotechnology, protein and enzyme biotechnology, bioremediation and aquatic eco-balance systems," KS Reddy, CEO, Biogenus India Ltd, said. The marine biotech research station would focus on moving shrimp farming via traditional methods to defined farming using technological solutions developed by the company, Reddy said. Biogenus solution would help in maintaining oxygen levels of shrimps in ponds, controlling algae population, improving disease resistance, feed conversion ratio, prevention from viral diseases, reducing maturity time etc. The manufacturing plant, on the other hand, would focus on manufacturing enzymes and microbial cultures mainly targeted at exports. "We are looking at producing 15,000 tons of enzymes and microbial cultures in the first year of operation," he said. Looking at the potential opportunities in marine biotechnology, Reddy said, "We see that India offers a big market for fish and shrimp media. Currently, the annual turnover of Indian seafood industry is around $9 billion and is one of the biggest foreign exchange earners for the country. India mainly exports shrimp, finfish, cuttlefish and squid across the world, with shrimps export being the largest. The technology developed by Biogenus will help the shrimp farmers to substantially increase their productivity levels without major mortality risks. " Biogenus India has signed an MoU with the Andhra Pradesh state government during the CII partnership summit held at Hyderabad early January 2003 to invest around $35 million towards setting up a technology development center and aquamedia plant in the state. Indian Biotech to get good VC funding A joint survey report of the Confederation of Indian Industry (CII) and Rabo India on financing biotech enterprises has said that biopharmaceuticals, bioinformatics and biotech services would be investors' main thrust area of investment. About 60-80 percent of funds indicated their preferences for this cluster. The next preference of the funds is agricultural biotechnology and genomics with 20-40 percent. About 10-20 percent of the investors have preference for medical devices and contract research. However, the report says, marine biotechnology and environmental biotechnology are not on the investment radar of the funds, as less than 10 percent of the investors have preference for these areas. The report has pointed out that the abundance of talented, qualified and cost -competitive human resources are the key features of the Indian biotechnology. Besides, internationally reputed information technology capabilities that can be applied in bioinformatics and availability of vast gene pool and large patient base, which can be used for drug development are boosting biotech sector in India, the report added. CII- Rabo India report noted some growth restricting factors that are hindering the progress and growth and investments opportunities in India. The factors include absence of adequate investments/risk capital, lack of quality entrepreneurs with sound business plans and commercial vision, lack of world class infrastructure facilities, inadequate government support and absence of apt regulatory/policy framework and inability of potential investors to assess intellectual property driven biotechnology business models. 'Effective policy implementation is the key' With the VC funds looking at growth investments, only a proper policy implementation can bring in more fund to support the biotech industry here, says Alok Gupta, assosiate director of Rabo India Finance. Speaking to BioSpectrum, Alok Gupta maintained that Rabo India has initiated a move in this direction by working with Maharashtra Industrial Development Corporation (MIDC) for a Biotechnology park at Hinjawadi near Pune. Public-private partnership is a best way for the growth of biotechnology industry in the country, said Alok Gupta, associate director, Head Life Sciences & Biotechnology, Rabo India Finance Pvt Ltd. Since the biotechnology is in a nascent stage in the country, he said, venture capital funds are not ready to take risks. At present the funds are looking at growth investments, and proper policy implementation will definitely bring in more funds to support the biotechnology industry in the country. He also observed that state governments should have to come out with more incentive packages instead of making noises. Besides government funding, big pharma companies have to take initiatives by offering projects to the SMEs on contract basis. Agreeing to the fact that biotechnology companies are struggling for their second round of funding, he pointed out that going in contract projects with overseas firms will definitely bring some relief to these companies. ]]> <![CDATA[Exposing the rot in science]]> https://biospectrumindia.com/news/95/1885/exposing-the-rot-in-science.html https://biospectrumindia.com/news/95/1885/exposing-the-rot-in-science.html Thu, 10 Apr 2003 11:12:00 +0530 The Bt cotton controversy refuses to die down. Environment Minister TR Baalu refuses to accept that the genetically modified (GM) crop - in the very first year of its commercialization - has failed in many parts of the country. The Andhra Pradesh Agriculture Minister, VS Rao, on the other hand has gone on record saying that farmers have not experienced very positive and encouraging results. At the same time, irate farmers have demonstrated at many a places demanding adequate compensation from the seed company - Mahyco-Monsanto. While the government as well as the company refuses to acknowledge the failure, and for obvious reasons, it is the failure of the scientific community to stand up and be counted that has been the biggest fallout of the unsavory debate. That the scientific community, more importantly the Indian Council of Agricultural Research (ICAR) - has preferred to maintain a silence over the Bt cotton debacle casts serious doubts about the kind of research claims that are being made. At the heart of the debate is a dubious research paper published in the distinguished American journal Science. David Zilberman and Matin Qaim, the authors of the controversial paper "Yield Effects of Genetically Modified Crops in Developing Countries" (Science, Feb 7, 2003, Vol. 299), have shown a stupendous increase in Bt cotton yields - averaging an increase of 80 percent or more - and have even gone to the extent of extrapolating this "phenomenal growth in production" to cover the entire range of GM crops for the developing countries. The authors accept that they used the official-trial record for pest infestation. The data about yield (and inputs) was based on personal interviews with farmers. This unfortunately is not the way to conduct agricultural research analysis. Personal interviews are not the way to determine crop yields in agricultural research. The entire basis for this research was therefore faulty. But not even one agricultural scientist (from the public sector) stood up to challenge. The industry too is quiet. No wonder, they are clamoring for a single-window clearance for GM crops so that all rubbish in the name of improved technology can be thrust upon gullible farmers. What the authors did not mention was that, the data they talk about actually comes from Mahyco-Monsanto, who conducted the trials. They have a vested interest in promoting Bt cotton and how can the results be therefore called "independent and free of any commercial interests?" The entire exercise shows how scientific research was manipulated to show 'significant' higher yields. Before 2001, all trials were being conducted by Mahyco-Monsanto on small plots. In 2001, the ICAR also did trials - it makes a mockery of scientific research. Anyway, if the yields increases were so high, no one is willing to tell us why did the crop fail at various places in the very first year of commercialization? And that too when the cotton areas were faced with an unprecedented drought which means that the insect incidence was very low? How come Bt cotton faced an attack of American bollworm, the insect against which it is supposed to be resistant, in the very first year of commercialization? Bt cotton episode has surely exposed the rot in modern science. The rot is not only confined to Indian science but is global in extent and reach. Pro-biotechnology scientists have spared no effort to uphold the shoddy research findings. This only goes onto prove that what is being pushed in the name of science and technology has other powerful commercial interest that scientists have begun to cater. To restore the credibility, there is a need to ensure that scientists are not allowed to be 'loudspeakers' for the multi-billion biotechnology industry. Scientists should speak for science and not for the industry. Accountability in science has to begin from the top. The silent majority among the scientific community is indicative of the fear that prevails in the corridor of scientific establishments. Scientists know that the only way to get a higher promotion is to sing the virtues of genetic engineering. And herein lies a grave danger. Devinder Sharma ]]> <![CDATA[Where we stand in Biotech]]> https://biospectrumindia.com/news/95/1893/where-we-stand-in-biotech.html https://biospectrumindia.com/news/95/1893/where-we-stand-in-biotech.html Wed, 09 Apr 2003 18:00:00 +0530 Biotechnology, one of the most important areas of human endeavor today, is comprised of about 30 different technologies which were outlined in BioSpectrum vol.: I, issue: I Biotechnology areas can be classified into four categories Areas where we have no or little expertise and where we are not doing anything substantial as of now. Areas where we have virtually all the expertise, yet we are not doing anything substantial. Areas where we have made a beginning and are progressing reasonably well. Emerging areas where our country has the potential of providing leadership as all the infrastructure and the basic capabilities exist with us. Let us look at each of these categories one by one. I would look at the first categories in this article and the last two in an article in the next issue. Areas where we have little or no expertise Gene therapy of human beings Xenotransplantation: that is, transplantation into humans from organs from other animals. For this purpose, as it turns out the pig appears to be the most suitable. Transplantation of organs from the pig on to humans leads to an acute and rapid rejection of the transplanted organ which cannot be taken care of by immunosupressants (such as cyclosporin) that are normally used to prevent an organ being rejected in the case of, say, transplantation of kidney from one human donor to another human recipient. However, it has been possible to genetically engineer a pig, the organs of which will not lead to such a rapid rejection. The prospects, therefore, for pigs serving as a source of organs for human beings, seem to be bright, and India must start working on this new technology Production of new materials such as biodegradable polymers using new ideas, observations, research findings. Processing of low-grade ores using microorganisms: Some work in this area was done a long time ago by Indian scientists, but no such process seems to have been so far commercialized in the country in spite of the fact that we have vast deposits of low-grade ores for a number of metals. Pushpa M. Bhargava, one of India's most brilliant scientists, has founded and directed the Centre for Cellular and Molecular Biology (CCMB), Hyderabad.His scientific contributions include the preparation and characterization of primary liver cell suspensions, identification of proteins from the seminal plasma and extensive characterization of one of these proteins and seminalplasmin. He has been awarded with Padma Bhushan, the Legion d' Honneur, the Wattumul Memorial Prize and Goyal Prize. Areas where we have virtually all the expertise but are not been doing anything substantial Production of monoclonal antibodies (MABs) for diagnosis and therapy: In spite of the fact that the technology for producing MABs, at least for diagnostic purposes, is available in a large number of laboratories in the country, we have not yet marketed a single MAB of our own. Plant and animal tissue culture: This is another area where we have an enormous amount of expertise around the country. However, in spite of the tremendous potential for selling exotic plants such as orchids grown through tissue culture, or growing skin for burn victims for which even processes are available within the country, leave aside producing products such as vanillin or taxol through tissue culture. We have not been able to commercialize any such project. In this regard we need to learn lessons from countries such as Thailand which is the largest exporter in the world of orchids grown through tissue culture. Standardization, validation and manufacture of traditional plant-based drug formulations This is by using good laboratory practice, good clinical practice, and good manufacturing practice, so that they may become prescription drugs around the world. We may have some 40,000 such formulations that have come to us through the four documented Indian systems of medicine (Ayurveda, Siddha, Unani and Tibetian systems) and the undocumented tribal systems of medicine. It is a pity that there is only one traditional drug formulation- Liv-52 manufactured by Himalaya Drug Company, which is a prescription drug outside India. Many organizations in the country, both in the private and the public sector, such as the CSIR and the Foundation for Revitalisation of Local Health Traditions (FRLHT) have put in an enormous amount of effort in collecting information, for example on medicinal plants. However, there is very little effort put in so far on an appropriate, computerized documentation of the actual formulations used in our traditional systems of medicine, on the basis of which documentation, using rational criteria, formulations could be chosen on a priority basis for standardization, validation and manufacture. d) Synthesis of peptides The making of synthetic peptides having commercial value in medicine, fisheries or veterinary practice. There are a fairly large number of institutionsâ€” both in the public and the private sectorâ€”which have all the expertise and even the equipment for making synthetic peptides and the protected amino acids required for peptide synthesis. However, there has been no concerted effort on a substantial scale to make peptides of quality for sale around the world, taking advantage of our expertise and the low cost of production. e) New cloning technologies These are especially for animals that could produce useful products. f) Use of PET-SCAN Positron Emission Tomography (PET) scan to be used either for research and diagnosis, by itself or in combination with magnetic resonance imaging (MRI) for which facilities exist around the country. In spite of PET- SCAN being one of the most powerful diagnostic and research tools available today, we do not have a single commercial PET-SCAN machine in the country which would be backed by an appropriate medical cyclotron to produce short-lived isotopes required for PET-SCAN analysis. g) Biosensors Biosensors is the area on which a number of commercial companies around the world are working. This is in spite of the fact that a report on Biosensors was prepared by a NGO, the Hyderabad Science Society, and submitted to the Government of India, some twodecades ago. h) Use of microbes for effecting chemically difficult transformations i) Biomediation, for example of effluents or wastes j) Development of protocol for technologies that would allow one to minimize the effects of biological warfare or bioterrorism Let us remind ourselves of the ingenious anthrax attack in the United States in 2001. Countries such as the United States are spending enormous sums of money on commercializable defence against biological warfare. A country so large as ours with the enormous advantages we have will do well to invest in a planned way, through cooperation between the public and the private sector, in the above areas, both for short-term and long-term gains. PM Bhargava ]]> <![CDATA[Link the traditional and modern knowledge systems]]> https://biospectrumindia.com/news/95/2352/link-the-traditional-and-modern-knowledge-systems.html https://biospectrumindia.com/news/95/2352/link-the-traditional-and-modern-knowledge-systems.html Wed, 09 Apr 2003 17:00:00 +0530 While building the Indian knowledge society, we will have to worry about three different domains of knowledge. As scientists, we focus rather narrowly only on Science and technology based knowledge, which is established through the rigorous methodology of science. But there are two other domains of knowledge, which we have kept away from. One is the so-called 'parallel', indigenous', 'traditional' or 'civilizational' knowledge system. These systems belong to societies in the developing world, that have nurtured and refined systems of knowledge of their own, relating to such diverse domains as geology, ecology, agriculture, and health etc., our Ayurvedic medicinal systems being one such domain. They were, as yet, neglected by modern science but not any more. New bridges between the modern and the traditional are being built. CSIR's pioneering partnership with Arya Vaidya Sala of Kottakkal is an example of the benefits of blending the modern science and the traditional knowledge. But this is only a small step, we have miles to go. Indigenous knowledge systems must be sustained through active support to the societies that are keepers of this knowledge, be they villagers or tribes, their ways of life, their languages, their social organization and the environments in which they live. We need innovative ways of preventing the erosion of such knowledge, which usually vanishes with people. Equally important, we need an in-depth analysis of the parallelism of insights between the indigenous knowledge systems, on the one hand, and certain areas of modern science concerned with fundamental aspects, on the other. Our university e ducation and research needs to shift the search light on this important issue, which it has neglected so far. Innovation is the key for the production as well as processing of knowledge. Indeed a nation's ability to convert knowledge into wealth and social good through the process of innovation determines its future. I wish to focus on the challenge of the resurgence of an innovative India, since there has been a fear that for some time now, the 'I' in India has stood for imitation and inhibition and not for innovation. In its rigorous form, such a scientific methodology includes observation, verification, repeatability, hypothesis-making, theorization and a formal and universally valid structure based on a minimum set of universal laws or principles. But there is another domain of knowledge, which has remained unacknowledged. Many societies in the  developing world have nurtured and refined systems of knowledge of their own, relating to such diverse domains as geology, ecology, botany, agriculture, physiology and health. We are now seeing the emergence of terms such as 'parallel', indigenous' and civilizational' knowledge systems. Such knowledge systems are also expressions of other approaches to the acquisition and production of knowledge. They were, as yet, neglected by modern science, as the pharmaceutical industry has realized. Distinctive Systems It must be recognized that indigenous and civilization knowledge systems, which evolved in different civilizations, led to distinctive systems worldwide and effected the emergence of diverse systems of social structure and governance. The growing dominance of a single view of the natural world as expounded by modern science will undermine these knowledge systems. Further, the process of globalization is threatening the appropriation of elements of this collective knowledge of societies into proprietary knowledge for the commercial profit of a few. Hence, an urgent action is needed to protect these fragile knowledge systems through national policies and international legislation, while providing its development & proper use for the benefit of its holders. There is a clear need for systematic and in-depth analysis of the parallelism of insights between indigenous and civilizational knowledge systems, on the one hand, and certain areas of modern science concerned with fundamental aspects, on the other. In particular, a strong linkage between the indigenous knowledge holders and scientists is needed to explore the relationship between different knowledge systems. For instance, there is a tremendous scope to develop eco-technologies based upon appropriate blends of traditional wisdom and modern science. Some of the greatest opportunities are provided, especially in the Indian context, in the area of traditional medicine. Shining Examples Examples of this new partnership between these two domains of knowledge are gradually emerging in India. Let me cite a couple of examples. The first is a medicine that is based on the active ingredient in a plant, Trichopus zeylanicus, found in the tropical forests of southwestern India and collected by the 'Kani' tribal people. Scientists at the Tropical Botanic Garden and Research Institute (TBGRI) in Kerala learned of the tonic, which is claimed to bolster the immune system and provide additional energy, while on a jungle expedition with the 'Kani' in 1987. A few years later, they returned to collect the samples of the plant, known locally as arogyapacha, and began laboratory studies of its potency. These scientists then isolated and tested the ingredient and incorporated it into a compound, which they christened "Jeevani" - giver of life. The tonic is now being manufactured by a major Ayurvedic drug company in Kerala. In November 1995, an agreement was struck for the institute and the tribal community to share a license fee and 2 percent of net profits. The process marks perhaps the first time that cash benefits have gone directly to the source of the knowledge of traditional me dicines and the original innovators. In the new innovation movement in India, we need to multiply such examples by thousands. We need a particular focus on community knowledge and community innovation. To encourage communities, it is necessary to scout, support, spawn and scale up the green grass root innovation. It will generate employment on one hand and it will use natural resources sustainably through linking of innovation, enterprise and investment. This will again require building up adequate linkages with modern science and technology and market research institutions. One will need new innovative models of development, employment generation and conservation of natural resources. CSIR is building such new innovation models by forging unusual local partnerships by reaching the unreached in the remote corners of India. A place called Athani, on the border of Maharashtra and Karnataka is the place from where Kolhapuri chappals come to us. They were till recently made by age-old traditional technique. Our scientists from CLRI studied this and helped them to reduce the processing time from 30 days to 10 days through application of some good science, the stamping process was standardized, certain innovative changes in design, based on computer aided techniques, were made to give more comfort to the wearer. But this was not a top down process. The oldest man in the village was consulted and he was convinced that the age-old traditions must change. Today several hundred artisans have been trained by CLRI. This has not only enhanced the family incomes of the villagers but also changed their perception of science, development and change - in short a micro social transformation. CSIR has realized that in this innovation chain, it is not techno-economics alone, but also the socio-economical and socio-cultural aspects, that it needs to be conscious about. RA Mashelkar ]]> <![CDATA[Biocon, Shantha in joint venture for human insulinÂ ]]> https://biospectrumindia.com/news/95/1118/biocon-shantha-in-joint-venture-for-human-insulin-.html https://biospectrumindia.com/news/95/1118/biocon-shantha-in-joint-venture-for-human-insulin-.html Wed, 12 Feb 2003 13:27:00 +0530 The Bangalore-based Biocon India and the Hyderabad-based Shantha Biotechnics announced a joint venture--Biocon-Shantha Biotech Ltd-- to manufacture human insulin in India. The joint venture will leverage the existing capabilities of both companies. In addition, an investment of Rs 20 crore would be made, said Varaprasad Reddy, managing director, Shantha Biotech.  According to the reports there will be collaboration on the technical side in manufacturing to be done at both facilities. The marketing will be done under their respective brand names in different geographies. Shantha Biotech has been working on the human insulin for the last three years and has developed a lab scale product. However, the company does not have the capacity to produce it on a larger scale. This is where Biocon will step in to do the â€œup scalingâ€? in its plafactor fermentation unit. The upscaling was not just translation of the seed to bigger volumes, but would involve some more technology inputs, Reddy said. The two companies were jointly working on this too. The bulk insulin will be sent back to Shantha Biotech for quality testing, vial ling and labeling, after which, it will be marketed by both in India.  Currently, the only human insulin that is available in the country is imported and an expensive one. The other less expensive variety is the one derived from cows and pigs. â€œHuman rejection of bovine/porcine insulin is very high,â€? Reddy said.  Shantha's corporate philosophy has been to make drug and vaccines available at affordable rates. The current market for insulin is estimated at Rs 150 crore (divided equally between human and animal insulin). Kiran Mazumdar Shaw, CMD, Biocon, hoped that the joint venture would help expand the market to Rs 1,000 crore. ]]> <![CDATA[Mahyco â€“Mansanto claims success of Bt cottonÂ ]]> https://biospectrumindia.com/news/95/1185/mahyco-mansanto-claims-success-of-bt-cotton-.html https://biospectrumindia.com/news/95/1185/mahyco-mansanto-claims-success-of-bt-cotton-.html Wed, 12 Feb 2003 13:27:00 +0530 The Mumbai-based Mahyco-Monsanto Biotech (India) Ltd has claimed that the three varieties of Bt cotton hybrids â€“ Mech 12, Mech 162, and Mech 184- have proved success. Farmers planted during last kharif season have lived up to expectations even as 65-70 percent reduction in the use of pesticides. There occurs an increase in income through higher yield. The company said that nearly 55,000 farmers harvested the insect-protected Bollgard, the first genetically modified crop to be planted in the country.  The sample study conducted by the company showed that an average increase in yield is 3.24 quintal per acre and an average reduction in the cost for the use of pesticide is Rs 770 per acre. And is translating an increase in income for farmers to the extent of Rs. 7,260 per acre. Four teams of the Government comprising scientists monitored the crop. The company distributed 1.05 lakh packets of Bollgard to the farmers of six states namely Andhra Pradesh, Gujarat, Karnataka, Madhya Pradesh, Maharashtra and Tamil Nadu. The company said that it has collected comprehensive information from a large sampe of farmers who completed their final picking in five states. ]]> <![CDATA[Icrisat to develop transgenic chickpea]]> https://biospectrumindia.com/news/95/1488/icrisat-to-develop-transgenic-chickpea.html https://biospectrumindia.com/news/95/1488/icrisat-to-develop-transgenic-chickpea.html Wed, 12 Feb 2003 13:27:00 +0530 The Hyberabad-based International Crops Research Institute for Semi-Arid Tropics (Icrisat), which is the first institute to develop transgenic groundnut in the world, has taken up a project for developing transgenic chickpea. The project is funded under by the Indo-Swiss collaboration in biotechnology. The transgenic chickpea would be tolerant to drought and low temperature stresses by using genes with regulatory functions such as drought responsive elements and osmo- regulation. The global demand for chickpea, as per Icrisat's estimates, will be around 11.1 million tons (mt) by 2010 as against 8.2 mt in 2001-02, an increase of 35 percent. About 85 percent of the additional demand will come from India. A combination of yield and area expansion is the possible option in meeting the projected additional demand. At present, global productivity of chickpea at 0.8 ton per hectare is far below the potential of five tons per hectare. ]]> <![CDATA[Wipro Healthcare acquires equity from CitadelÂ ]]> https://biospectrumindia.com/news/95/1623/wipro-healthcare-acquires-equity-from-citadel-.html https://biospectrumindia.com/news/95/1623/wipro-healthcare-acquires-equity-from-citadel-.html Wed, 12 Feb 2003 13:27:00 +0530 Wipro Healthcare Information Technologies Ltd. (formerly GE Medical Systems Information Technologies Ltd) has acquired 40 percent of its equity share held by Citadel Healthcare Ltd for Rs 97 million. DA Prasanna, executive officer, Wipro Healthcare and Lifesciences informed that upon closing, Healthcare Information Technologies Ltd will become a whollyâ€“owned subsidiary of the Wipro Limited Prasanna, while replying to a question said that Wipro Healthcare Information Technologies Ltd would continue in concentrating and offering solutions to hospitals and health insurance companies for efficiencies and compliance in work flows. It will also reduce drug discovery cycle time for Life Sciences companies, in India and across the globe. Wipro Healthcare and Lifesciences was set up as a separate business segment of Wipro Ltd in April 2002 to address the requirements of the Bio-IT market, where information technology converges with life sciences.  For the quarter ended 31 December 2002, Wipro Helthcare and Lifesciences business segment recorded revenue of Rs 246 million registering a growth of 35 percent over the corresponding period last year. However the revenue earned during the quarter two of 2002-03 fiscal was Rs 248 million. IT related services provided by the segment accounted for 38 percent revenue and revenue from Wipro Healthcare Information Technologies Ltd accounted 10 percent. Products and services sold in the Indian market through the Wipro Biomed division accounted for 52 percent of revenue. ]]> <![CDATA[SSI introduces bioinformatics courseÂ ]]> https://biospectrumindia.com/news/95/1633/ssi-introduces-bioinformatics-course-.html https://biospectrumindia.com/news/95/1633/ssi-introduces-bioinformatics-course-.html Wed, 12 Feb 2003 13:27:00 +0530 The Chennai-based SSI Ltd has introduced a one-year full time course on bioinformatics. The course covers various bioinformatics related topics such as proteomics, genomics, bioinformatic tools, bioweave, molecular biology, pharmaco genomics and advanced Genetics. According to the company's press release, at the end of the course, the student will be allowed to take up a project, where in he will apply his bioinformatics knowledge to an area of his choice. The release says that SSI would offer the course in association with Gemiosys Research Labs, a Chennai based research organization working in the field of Biotechnology and specializing in bio-informatics. It has a varied experience in the development of scientific computing, networking and high throughput platforms to aid research in the area of drug discovery, says the release. ]]> <![CDATA[Zydus decides to merge German Remedies into Cadila]]> https://biospectrumindia.com/news/95/1640/zydus-decides-to-merge-german-remedies-into-cadila.html https://biospectrumindia.com/news/95/1640/zydus-decides-to-merge-german-remedies-into-cadila.html Wed, 12 Feb 2003 13:27:00 +0530 The Zydus Group has decided to merge German Remedies Ltd and Recon Healthcare Ltd into the group's flagship company - - Cadila Healthcare Ltd. Earlier the Zydus Group had acquired the majority stake in the Mumbai-based German Remedies Ltd. With this Cadila Healthcare, became the fourth largest pharmaceutical company in the country with a post-merger market share of 3.82 percent. With the completion of the merger the Cadila Healthcare's turnover is expected to cross Rs 1,030 crore with a profit of over Rs 110 crore.  â€œWe believe that there should only be one single listed entity in the group, especially with respect to companies in similar, competing lines of business. This merger would maximize value for the shareholders of both the companies and achieve complete alignment of interests,â€? says Pankaj R Patel, chairman and managing director, Zydus Cadila.  According to the reports, the Zoom Properties and the Zydus Pathline, two wholly owned auxiliaries of Cadila Healthcare, will also be merged into it. Post-merger, the 100 percent subsidiary of German Remedies, German Remedies Specialities Ltd, will become a 100 percent subsidiary of Cadila Healthcare. ]]> <![CDATA[Ram Naik launches Gasohol in India]]> https://biospectrumindia.com/news/95/2307/ram-naik-launches-gasohol-in-india.html https://biospectrumindia.com/news/95/2307/ram-naik-launches-gasohol-in-india.html Wed, 12 Feb 2003 13:27:00 +0530 Ram Naik, minister of petroleum & natural gas, Government of India, launching the supply of five percent ethanol blended petrol, said that Gasohol would be supplied in parts of Andhra Pradesh, Maharashtra, Punjab and Uttar Pradesh starting from 1 January 2003, as part of the Government's decision to cover the entire areas of the first phase nine states and four contiguous union territories fully by June 2003.  Naik said that this would help sugarcane farmers and would support in building up the oil security apart from benefiting the environment. The states that are covered under the first phase include Andhra Pradesh, Goa, Gujarat, Haryana, Karnataka, Maharashtra, Punjab, Tamil Nadu and Uttar Pradesh and four Union Territories of Chandigarh, Dadra & Nagar Haveli, Daman & Diu and Pondicherry. The minister maintained that preparedness of state governments, oil companies, sugar co-operatives and other Agencies was reviewed from time to time. Though oil companies have completed their arrangements in this regard, the state governments other than Maharashtra and Uttar Pradesh could not develop the infrastructure to produce anhydrous ethanol and sought more time.  The official sources reported that in response to the tenders floated by oil companies for ethanol requirements of three months from January to March 2003, there is a short fall of about 35,000-kl anhydrous ethanol. Maharashtra is the only state where infrastructure has been developed fully to meet the requirement. As the current total consumption of gasoline in these nine states and four union territories is about 4.6 million tones per year, the requirement of ethanol at five percent blend ratio works out to 320-350 million liters. ]]> <![CDATA[JNU scientists develop 'protato'Â ]]> https://biospectrumindia.com/news/95/2347/jnu-scientists-develop-protato-.html https://biospectrumindia.com/news/95/2347/jnu-scientists-develop-protato-.html Wed, 12 Feb 2003 13:27:00 +0530 A team of scientists at Jawaharlal Nehru University in New Delhi has developed a GM Potato. The team has called it as 'protato'. According to a report in the New Scientist magazine the team of scientists lead by Asis Datta at the JNU added the AmA1 gene to potatoes, with the result that they make a third more protein than usual, including substantial amounts of the essential amino acids lysine and methionine. The report says that AmA1 is a gene from the amaranth plant, a crop long grown by native South Americans and now available in some Western health food stores. The report also adds that the Government of India is keen on using GM potatoes to solve malnutrition problems among its poorest children. The use of GM potatoes forms part of a three-pronged approach contained in a 15-year plan to tackle malnutrition and reduce childhood mortality in India. ]]> <![CDATA[Ranbaxy files 2 NDAs in USÂ ]]> https://biospectrumindia.com/news/95/2652/ranbaxy-files-2-ndas-in-us-.html https://biospectrumindia.com/news/95/2652/ranbaxy-files-2-ndas-in-us-.html Wed, 12 Feb 2003 13:27:00 +0530 Ranbaxy Laboratories Ltd, India's largest pharmaceutical company, has filed two New Drug Applications (NDAs) in the US for Metformin and Ofloxacin during the quarter ending 31 December 2002.  According to the company's press release, Ranbaxy has, so far, filed 23 NDAs during the year 2002 and received 11 approvals taking the cumulative number of approvals to 58 with 37 pending approvals. Final approvals from the US Food and Drug Administration (FDA) to manufacture and market Amoxicillin for oral suspension USP, 200 mg/5 ml and 400 mg/5 ml, Isotretinoin, 10, 20, and 40 mg capsules and Co-amoxyclav 500mg/125mg (base) tablets were also received during the quarter ending 31 December 2002. The release says that Ranbaxy, which is selling its products in over 70 countries, will soon receive approval for RBx 7644 (Ranbezolid), an extended spectrum Oxazolidinone from the Drugs Controller General of India, to commence Phase I clinical trials for both its oral and intravenous usage form in India. RBx 7644 (Ranbezolid) is presently undergong Phase I clinical trials in the UK. Commenting on the business results, DS Brar, CEO & managing director, Ranbaxy Laboratories Ltd said, â€œ the results have been very encouraging. We have been able to significantly improve our operational effectiveness and financial performance. A sound base has been established to enter into the speciality products segment in key developed marketsâ€?. ]]> <![CDATA[AP signs MoU with AP BioNet]]> https://biospectrumindia.com/news/95/6785/ap-signs-mou-with-ap-bionet.html https://biospectrumindia.com/news/95/6785/ap-signs-mou-with-ap-bionet.html Wed, 12 Feb 2003 13:27:00 +0530 The Government of Andhra Pradesh and Asia-Pacific Bioinformatics Network (APBioNet) have signed a Memorandum of Understanding (MoU) at Singapore. The MoU will enable the Life Sciences Research Institutions in Andhra Pradesh, such as, CCMB, CDFD, IICT, NIN etc. to be a part of the Global Research Network, which has a focus on Bioinformatics. Prof. Shoba Ranganathan, Vice President, APBioNet and BP Acharya, secretary, Industries, Andhra Pradesh signed the MoU. The government has also signed another MoU with Pacific Healthcare Holding Ltd, a Singapore-based Corporate Hospital for setting up a Stem Cell Research Center and state-of-the-art maternity hospital in Hyderabad. Dr William Chong, managing director of the Pacific Healthcare Holdings and BP Acharya, secretary, Industries, signed the MoU. ]]> <![CDATA[JNU to set up Knowledge Park]]> https://biospectrumindia.com/news/95/7563/jnu-to-set-up-knowledge-park.html https://biospectrumindia.com/news/95/7563/jnu-to-set-up-knowledge-park.html Wed, 12 Feb 2003 13:27:00 +0530 The Jawaharlal Nehru University (JNU), New Delhi is planning to set up a â€œKnowledge Parkâ€? on its campus to promote active interaction of its faculty and students with Research and Development arms of knowledge based industries.  According to a University press release, JNU has considerable expertise in the areas of information and biotechnologies. In addition university has a highly motivated student body, which represents the cream from the country since students are selected through stringent national tests. An interaction between the university brain pool and industries in these areas at this crucial phase of national development can make a lasting impact on the growth of these industries in the country.  Knowledge Park in JNU will provide vast opportunities to JNU students in the form of internship opportunities and short term employment opportunities. Technology / Knowledge parks are coming up in most frontline universities all over the world. JNU can provide a lead in this area nationally and in this process make a unique and crucial contribution to nation building. Space / Laboratories created in the knowledge park will be leased out to frontline R&D companies in the areas of information technology, life sciences and biotechnology, social sciences, languages and other emerging technologies, for e.g. Robotics and Nanotechnologies. JNU will provide land for developing the knowledge park on its campus. Support facilities like computer network, administrative support and crucial research infrastructure will be available in â€œJNU Knowledge Park (JKP)â€?. The JKP will be under the administrative control of JNU and evolve as its integral part.  While some seed money may be made available for JKP by UGC, basic funding for establishing JKP is expected to come from non-UGC sources, according to the university press note. Innovative ideas will be explored to rope in funding for JKP. Besides promoting interactions between academics and industry, JKP is expected to generate extra funds for JNU. These funds will be utilized for maintenance of JNU infrastructure, supporting numerous intra-university academic activities and support to needy students from weaker sections of society. While planning for the JKP, special care should be taken to ensure that the Park should have a positive impact on the environment in the campus. Green cover would increase and water bodies created. Optimal utilization of water resources would be planned. Wastewater treatment plants should be incorporated in the plan so that the wastewater after treatment can be used for horticultural purposes. ]]> <![CDATA[Hunger, food and Genetic engineeringÂ ]]> https://biospectrumindia.com/news/95/2695/hunger-food-and-genetic-engineering-.html https://biospectrumindia.com/news/95/2695/hunger-food-and-genetic-engineering-.html Tue, 11 Feb 2003 11:42:00 +0530 The United States is visibly unhappy. India's refusal to accept 1000 tons of food aid has brought the controversy shrouding the safety of genetically modified (GM) foods right to its shores. And the battle lines are getting clearly drawn. The US Embassy in New Delhi and the United States agency for international development (USAID) have already swung into action. While CARE India and catholic relief services (CRS), which wanted to carry the relief supplies, have moved the environment appellate authority (EAA), seeking reconsideration of the decision, the battle has moved onto the media columns, mainly in the American press and for obvious reasons. It was the genetic engineering approval committee (GEAC)--the country's highest regulatory authority--that refused to accept the food aid unless certified that the shipment did not contain Star-link GM corn, which has been certified in the US only for animal feed consumption. The fact that India has an unmanageable foodgrain surplus exceeding 51 million tonnes, much of it rotting in the open, is kept under wraps. The relief agencies have continued to dilly-dally for nearly two years, refusing to make a commitment. For the multi-billion dollar biotechnology industry, the acceptance of the GM food aid by India is crucial to its sagging morale over the consumer backlash that has kept the genetically altered food out of Europe. After all, how can a nation with millions in the clutches of hunger and starvation refuse a humanitarian aid? But what is being kept under wraps is the fact that India has an unmanageable foodgrain surplus exceeding 51 million tons, much of it rotting in the open. Importing food, even if it is part of the relief aid supplies, will therefore render more and more of the food stocked within the country to go waste. For the US, on the other hand, the major headache is to get rid of its burgeoning GM food stocks that remains piled up for want of buyers. What happens as a result to the food security concerns in India is none of its concern, it never was. The biotechnology industry as well as a dominant section of the scientific community, thinks that genetic engineering, despite the risks involved for human health and environment, is essential for meeting the food requirements in the next quarter of the century. Whether it is food aid or the introduction of GM crops, the world must open up for the sake of the hungry millions in the year 2030. Not realizing that the world has an over-production of food in the year 2003. The Indian government, for instance, has been asking farmers not to produce more wheat and rice and in turn diversify from staple foods to other commercial crops. And yet, highly subsidized food from the Organization for Economic Corporation and Development(OECD) countries is being slowly and steadily dumped into the developing countries thereby further accentuating the crisis on the farm front. India too is gradually moving towards cheaper food imports as the answer to food security. It is, therefore, obvious that either the governments do not know of the threat on the food front that lies ahead or the scientists are not aware of the ground realities. The fact is that it is the scientists, more importantly the biotechnologists, who refuse to look beyond their research laboratories. The emphasis on biotechnology in the developed world is linked to the global paradigm that aims at destroying food self-sufficiency in the majority world. Given the pathetically small land holdings in the developing countries and with the mounting farm debt, it is futile to expect that the sophisticated technology can rescue resource-poor farmers and rebuild their confidence in agriculture. Food production will have to come from agricultural systems in countries with huge populations like India. Farmers are not only resource poor â€“ with no or little access to credit, and markets â€“ but also a majority of them live in arid and semi-arid zones or in harsh climates. India has come a long way since the days of 'ship-to-mouth' existence. Forcing biotechnology and genetically modified foods will only push the country into the era of 'lab-to-mouth', the socio-economic fallout of which can be disastrous. Devinder Sharma The author is a well-known food and trade policy analyst. He also chairs the New Delhi-based Forum for Biotechnology and Food Security. Responses can be emailed at: dsharma@ndf.vsnl.net.in ]]> <![CDATA[Mentoring the Biotech firms]]> https://biospectrumindia.com/news/95/2706/mentoring-the-biotech-firms.html https://biospectrumindia.com/news/95/2706/mentoring-the-biotech-firms.html Tue, 11 Feb 2003 11:42:00 +0530 When the anthrax scare hit the world headlines last year, only one company was not afraid. For, it did not shy away from seeing a marketing opportunity in the outbreak of the epidemic by making available a new technology vaccine for anthrax developed in the laboratories of Jawaharlal Nehru University (JNU), New Delhi.  The company, the Biotechnology Consortium of India (BCIL), played the crucial role in transferring the vaccine technology developed by JNU's department of biotechnology(DBT)to a medical firm, Panacea Biotech, facilitating the manufacture of the vaccine on a commercial scale.  Today, Panacea Biotech is ready to commercially launch the vaccine in the market. Naturally, BCIL is smiling, as the potential sales of this vaccine are immense, fetching it an all-time high know-how fee of Rs two crore for the technology transfer excluding the royalties it will get from the sales. This recombinant vaccine will be available for first time in the world developed by fermentation using ribosomal deoxyribo nucleic acid (rDNA) technique by the JNU biotechnologists, replacing the old method of using sheep brain tissue to produce the vaccine. Quietly but surely, BCIL is behind the biotechnology revolution in India. The company, set up with the objective of facilitating accelerated commercialisation of biotechnology, has been behind the transfer of many key medical, agricultural and environmental technologies including diagnostics for HIV 1 and 2, dengue, japanese encephalitis, and hepatitis A and therapeutics such as the recombinant anthrax vaccine.  Quiet Birth BCIL's birth was unique. With scientists being wary of looking for commercial gains from their research and the DBT not wanting to defile its hands looking for profits, a separate company was set up to provide the linkages between the industry and the scientists. â€œBCIL was incorporated as a public limited company in 1990 with token equity participation from DBT and rest of the corpus coming in from financial institutions (FIs) and the corporate sector,â€? says Dr SR Nair, managing director, BCIL. A corpus of Rs 5.3 crores was contributed by FIs including IDBI, ICICI, IFCI and UTI. Ranbaxy, Glaxo, Cadila laboratories, Lupin, Rallis, SPIC and a few other corporate houses also contributed to this corpus. BCIL has three government secretaries in its board of directors and representation from the FIs and corporates, but functions independently.  â€œ In biotech investments, we are way behindâ€? - Dr S R Nair, managing director, BCIL Dr SR Nair is a scientist at heart but has turned into a successful venture capitalist. Over the years he has successfully started and managed venture funds for the Andhra Pradesh industrial development corporation, Hyderabad and the Risk Capital and Technology Finance Corporation, New Delhi, which has helped him turn the Biotechnology Consortium of India (BCIL) into a thriving company, leading the biotechnology revolution in India. His basic training was in chemistry with a master's from University of Kerala and a doctorate in polymer chemistry from the University of Manchester, UK. After a stint as a polymer scientist at the Shriram Research Institute, New Delhi, Dr SR Nair shifted to venture funds. His experience in both the scientific and venture fund management have come handy in running BCIL.  He has not only facilitated the commercialisation of biotechnology in the country but is now onto starting biotech parks in the country and a venture funding biotech projects. In an interview to Bio Spectrum, Dr SR Nair talks about the future of biotechnology in the country. The booming biotechnology industry in India and Dr SR Nair's background in managing venture capital funds had proved to be a bonus for BCIL. â€œWe have not touched the corpus of Rs 5.3 crore as yet,â€? he says, proudly. In fact BCIL has been growing at a steady rate of 15 per cent per annum, with a turnover of Rs 2.5 crore this year. â€œSix years ago, our turnover was Rs one crore, today it has crossed Rs 2.5 crore,â€? Dr SR Nair says. â€œAcross the country, government and university laboratories have been successful in developing many new technologies based on biotechnology. But it was their experience in realising these products into commercial ventures that saw BCIL  taking shape,â€? explains Dr Purnima Sharma, general manager and co-ordinator (technology transfer), BCIL. Since its inception more than a decade ago, BCIL has become the perfect interface between the research laboratories and companies looking for new technologies. Little wonder then that today both companies looking for new technologies and research labs looking for partners approach BCIL. The success of some of the technologies that BCIL has transferred to launch successful commercial products is perhaps the reason for so many people knocking at its doors. One of its biggest success stories is helping the cancer research institute, Mumbai, see the commercial realization of its fool-proof HIV 1 & 2 testing kits based on the Western Blot technique. â€œThis is a unique products as no other test is 100 percent error-proof. BCIL evaluated the product through DBT and then packaged its salient features in such a manner that commercialisation would be easy. We transferred the technology to J Mitra and Co., a Delhi-based diagnostics manufacturer, who is now ready to export these kits to African nations and the East Asia countries,â€? points out Dr Purnima Sharma. The evaluation of the products is done by DBT or an independent agency on a case-by-case basis. â€œBCIL looks into all aspects of scaling up the technology from the lab level to the commercial level,â€? she explains. With the HIV 1 & 2 testing kits, initially blood bags were being used to culture the virus but when the ban on the sale of blood bags came into force,  BCIL helped in finding an alternative method of culturing the virus,â€?  Dr SR Nair says. Many times a product may not be ripe for commercialization and the lab has to work on improving the technology. â€œWith our vast contacts in the field, we are able to help them in improving their technology,â€? says Dr SR Nair. For its efforts, BCIL charges a know-how fee and gets royalties from the company. â€œWe usually keep the know-how fee low and recover the balance from the royalties. This fees vary according to the market potential of the product,â€? explains  Dr Purnima Sharma. So, a product like the anthrax vaccine fetched much higher know-how fees as it has vast market potential. BCIL is slowly expanding its repertoire of skills. Other than technology development and transfer, BCIL is working on syndication of funds from FIs for eligible biotech projects. The latest addition to its portfolio is the setting up of biotechnology parks in six locations, Kerala, Pondicherry, Andhra Pradesh, Uttar Pradesh (Greater Noida and Lucknow) and Punjab. â€œIn Hyderabad, a location has been identified and many companies have already set up infrastructure there. BCIL will be the consulting agency for these companies,â€? says Dr SR Nair.  Despite staff strength of seven professional biotechnologists, other than the support staff, BCIL has been able to crank-up the biotechnology revolution in India. And with a sunny forecast for the biotechnology industry, BCIL's future too looks bright.  Interview with Dr S R Nair Q: How does India compare with other countries in biotechnology development? A: India is quiet advanced in biotechnology. Quality-wise, we are not far behind any developed nation, but investment-wise, we are way behind. Our total investment in biotechnology research & development (R&D) by the government is about Rs 100 crore, equal to what a single corporate in the US invests in biotechnology. Even the big Indian companies like Ranbaxy, Wockhardt, Nicholas Piramal or Dr Reddy's have moderate investments of Rs 350 to Rs 400 crore compared with what US corporations pump into their R&D set ups. We really need to setup investments in biotechnology R&D to keep pace with world standards. Q: Which are the fastest growing areas in biotechnology in India? A: Agriculture and medical biotechnology are two areas in which there is rapid growth. Within agriculture, organic farming has huge potential and will be a major focus area for BCIL. Along with the ministry of commerce, we will look at exports of rice, horticulture products, oilseeds and honey produced from organic farms.  Q: What is BCIL's role in organic farming and what is the market potential for these products? A: We are already in the process of setting up model farms and organic agricultural zones for rice in Assam and Orissa, for oilseeds and horticulture in Madhya Pradesh. Organic cultivation in the North East is much simpler as the farmers there have not been using pesticides, one of the major criteria for organic produce.  Europe is a big consumer of organic products. People pay more for organically grown food there. But India's biggest problem was certification. BCIL played a role in standardization and accreditation of the standards with European governments. For example, a farm has to be free of pesticides for three years before organic cultivation can begin. BCIL has now trained the staff of tea, coffee and spices boards so that they can oversee the production on organic farms. Q: Are there any other areas in which India can excel? A: Yes, areas like medical plant extraction, bio pesticides and bio fertilizers have huge potential in the western markets and we must focus attention on these areas. BCIL has already identified 20 species of medicinal plants from which core extracts can be made. We are also trying to promote in-situ cultivation of medical plants so that our biodiversity is preserved. Q: What role do you see for BCIL in the future? A: Biotechnology is a growing industry and will grow by more than three-folds in the next decade. BCIL will have a very large role to play especially in assisting companies to get regulatory clearances. Many new entrants find this to be a major bottleneck and BCIL can play an intermediary role here.  BCIL will soon begin to venture fund biotechnology projects that have great commercial potential. We could even look at soft loans for technology development and are working with FIs to work out a deal. Awareness generation will be another important area of emphasis. Biotechnology is such a new area that the fear of the unknown plays on the minds of the people. We need to work with them and change these perceptions.   Vidya Deshpande ]]> <![CDATA[Trading se le ke Technology Sharing tak]]> https://biospectrumindia.com/news/95/1530/trading-se-le-ke-technology-sharing-tak.html https://biospectrumindia.com/news/95/1530/trading-se-le-ke-technology-sharing-tak.html Mon, 10 Feb 2003 18:34:00 +0530 With a vision â€œAbundant Food and a Healthy Environmentâ€? and having its presence in India for over 50 years, Monsanto India Ltd was anxiously waiting for the day. It was 26 March 2002. The genetic engineering approval committee(GEAC), department of environment and forestry, Government of India has finally approved for the commercialization of the country's first biotech crop, insect protected Bt (Bacillius thuringiensis) cotton, which was developed by Mahyco Monsanto Biotech (India) Ltd a 50:50 joint venture between Maharashtra Hybrid Seeds Company (Mahyco) Ltd and Monsanto.  The process of developing and conducting field trials for Bt cotton took over a decade. In the litmus test the Mahyco Monsanto Biotech (India) Ltd's three Bt cotton varieties -- MECH 12 Bt, MECH 184 Bt, MECH 162-- Bt showed good results and emerged with flying colors. This has paved a way for Monsanto India to look ahead in the plant biotechnology in India. Monsanto in India  Milestones 1949: Monsanto kicked off its activities in India as a  trading company 1973: Machete, the first rice herbicide was launched  1991: Roundup, a general weed controller, was launched  to provide solution to plantation growers  1990s:  Mahyco approached Monsanto for Bt technology sharing  1997:  Monsanto entered into a strategic alliance with  Mahyco  1998:  Leader, a new generation herbicide, was launched  in for post-emergent weed control in wheat  1998:  DBT approves Mahyco-Monsanto to conduct  Bt cotton trials. 2000:  Monsanto integrated all its agricultural business  activities in India 2002:  In 29 March, a joint venture with Mahyco, Monsanto launched India's first GM crop-- Bollgard Bt cotton. Monsanto India Ltd, a subsidiary of the US based Monsanto Company has been operating in India for 50 years. Seeing the vast market for their range of products in India's agrarian society, it started as a trading company in 1949. Moving on to seed production, the company has been providing farmers with products that have contributed substantially to agricultural productivity and crop management practices for the past 25 years,.  Monsanto India with its commitment of adopting best global practices of corporate governance has made a significant milestone in the Indian agriculture sector.  Sekhar Natarajan, managaing director, Monsanto India Ltd, says, â€œMonsanto is committed to work with the appropriate government/statutory authorities to develop useful technologies through local institutions and companies, in full compliance with the country's laws and safeguards. We believe in working with and co-operating closely with the public and private sectors and research institutions to ensure the farmer's right to choose the most appropriate technologies, to boost yields in keeping with the principles of sustainable development.â€? In 2000, Monsanto integrated all its agricultural business in India, making itself a comprehensive agriculture inputs provider. Its main areas of strength are herbicides, seeds and traits with a focus on four key crops â€“ rice, wheat, cotton and maize. The company has developed unique solutions and products to help farmers to enhance yields and improve environmental quality in a sustainable way.  Having its corporate office at Mumbai and research center at Bangalore, Monsanto strives to provide quality, cost-effective and integrated approaches for improving farm productivity to produce better quality foods, strictly adhering to stringent standards for eco-care and safety. Monsanto has many revolutionary products and technological breakthroughs in the agricultural sciences to its credit.  On Biotech in India Sekhar Natarajan of Monsanto says, â€œthe prospect for biotechnology in India is very bright. A large number of organizations, both public and private are engaged in cutting edge research in India, many of whom is in the early process of commercialization. In combination with the existing agricultural practices, agricultural biotechnology will have a huge impact on the agricultural productivity of the country and its economy.â€? â€œWith the existing agriculture practices, the agricultural biotechnology will have  a huge impact on the agriculture productivity in India and its economyâ€?, says Sekhar Natarajan, managing director , Monsanto India Ltd Modern biotechnology, if used responsibly, can advance India's agriculture to address the challenge of feeding its increasing population with limited economic, land, and water resources. Crop damage can be minimised through disease and pest resistant varieties, which will also reduce the use of chemicals. However, he says, â€œsince biotechnology is new to the country, it is necessary to educate the public about this technology. Public must be made aware of its benefits. This needs to be initiated by the government as well as other players in the field through a variety of mediums ranging from scientific seminars to inclusion of related topics in school curricula.â€? Establishing its mark  Monsanto through its different product strengths and its humsafar goal has made remarkable achievement in terms of market capitalization in India in the last five years.  Monsanto's humsafar goal has provided small holders a one-stop total solutions package to increase crop value in terms of yield and better prices for their produce. It also provided education on better agronomic and farm management practices, thereby increasing the profitability of the small farmers. This has helped them to reach the larger audience in the Indian agriculture sector. Monsanto India has made a significant achievement in the last five years, from a market capitalization of Rs 132 crore in 1999-98 to Rs 459 crore in 2001-02. Besides its domestic market the company has also focussed on the export front. Nearly 15 percent of its sales revenue comes from exports.  The company has doubled its export volume to Rs 49 crore in 2001-02 from Rs 25 crore during the previous year. Monsanto exports seeds, especially maize to South-East Asia (Indonesia, the Philippines and Thailand). They earned Rs 42 crore in foreign exchange through seed export during 2001-02. Product scenario  Monsanto's work in India began soon after independence. As a committed participant in the seed industry, it has come up with hybrid and high-yielding crop varieties of corn, sunflower and cotton.  Monsanto launched Machete, the first rice herbicide in India in 1973, and has revolutionized rice cultivation in the country since then. At the same time it also launched Lasso for weed control in vegetables and soybeans which still continues to be a leading weed control tool for soybean farmers in western India. Its Roundup has been providing plantation growers with a leading-edge weed control solution since 1991. Roundup has gone on to become an important weed control product for large and small scale farmers, throughout India. Leader, a new generation herbicide, was launched in 1998 for post-emergent weed control in wheat.  Through its field operations, knowledge of agricultural production and constant search for new agricultural solutions and technologies, Monsanto seeks to develop, communicate and provide sustainable solutions to Indian farmers.  Social responsibilities  In a country like India, where the rising population, natural calamities like floods, and drought due to poor monsoon have pushed the private sector to take up social responsibilities. As Monsanto is into agrisector, it has felt the necessity of funding the research organizations that aim at identifying genes capable of making crops drought tolerant. In 2001-02 Monsanto has granted the first installment of $24,000 to the University of Agricultural Sciences, Bangalore, out of committed $40,000 for the two-year project. In addition to funding the agri-research organization, Monsanto also runs some community outreach initiatives. â€œMonsanto Vidyarthiâ€? is a programme for educating children. Other projects include training farmers with smallholdings on agricultural techniques under the banner of â€œVanaraiâ€?, which improves their crop productivity and preserves the environment. Future of Monsanto India  With all the hurdles they came across, Monsanto is still in action and will continue to remain committed to Indian agriculture sector by providing unique solutions and products to the farmers that will help them to enhance agricultural yields and improve environment quality in a sustainable way. Sekhar Natarajan emphasises that the company will continue to focus on its areas of strength, the core businesses of herbicide, seeds, and traits as it concentrate on key crops--rice, wheat, cotton and maize.  Narayan Kulkarni ]]> <![CDATA[Building borderless minds and borderless thinking]]> https://biospectrumindia.com/news/95/1648/building-borderless-minds-and-borderless-thinking.html https://biospectrumindia.com/news/95/1648/building-borderless-minds-and-borderless-thinking.html Mon, 10 Feb 2003 18:34:00 +0530 Modern scientists may not realize it, but they are followers of Gandhi in one fundamental respect. Gandhi campaigned for simplicity. The hallmark of great science is indeed simplicity. Equations like E=mc2 or F=ma, are path-breaking, simply because they are so simple. Unfortunately, when it comes to harnessing technology for life style, things become more complex and complicated. Gandhiji implied that our mind should be open and uninhibited. It should be open to new ideas and new thinking. There should be no artificial boundaries and walls or borders between the people. A borderless mind and borderless thinking alone can lead to a borderless world.  Science is built on facts. Scientific knowledge is proven knowledge, it is objective and verifiable knowledge. Hence it is considered to be reliable. In essence, the scientific method consists of careful observation of nature and cautious confirmation of all conclusions. Good science excludes all unsubstantiated hypotheses. Observation and experiment are the methods of science. As new observations are added to the total body of scientific knowledge, some of the older observations lose their relevance and become obsolete. This dynamic aspect of science is perhaps its most outstanding attribute. We need to recognize that scientific knowledge generated in formal laboratories is not the only knowledge system. There is knowledge generated in the 'laboratories of life' by people over centuries. Many societies in the developing world, like India, have nurtured and refined systems of knowledge of their own, relating to such diverse domains as geology, ecology, botany, agriculture, physiology and health. We are now seeing the emergence of terms such as 'parallel', 'indigenous' and 'civilizational' knowledge systems. Such knowledge systems are also expressions of other approaches to the acquisition and production of knowledge. The process of globalization is threatening the appropriation of elements of this collective knowledge of societies into proprietary knowledge for the commercial profit of a few. These fragile knowledge systems need to be protected and enhanced through national policies and international legislation, while providing its development & proper use for the benefit of its holders. It is only now that we are bringing to see the benefits of bringing down the walls between the two domains of knowledge. Let me cite an example. It pertains to a medicine that is based on the active ingredient in a plant, Trichopus zeylanicus, found in the tropical forests of southwestern India and collected by the Kani tribal people. Scientists at the Tropical Botanic Garden and Research Institute (TBGRI) in Kerala learned of the tonic, which is claimed to bolster the immune system and provide additional energy, while on a jungle expedition with the Kani in 1987. A few years later, they returned to collect the samples of the plant, known locally as arogyapacha, and began laboratory studies of its potency. These scientists then isolated and tested the ingredient and incorporated it into a compound, which they christened â€œJeevaniâ€? â€“ giver of life. The tonic is now being manufactured by a major Ayurvedic drug company in Kerala. In November 1995, an agreement was struck for the institute and the tribal community to share a license fee and two percent of net profits. The process marks perhaps the beginning of the healthy respect that the practitioners of the modern science are developing for holders of traditional knowledge. Thomas Henry Huxley said in 1881, â€œIt is easy to sneer at our ancestors â€“ but it is much more profitable to try to discover why they, who were really not one with less sensible persons than our own excellent selves, should have been led to entertain views which strike us as absurdâ€?. It is in this spirit that we should build a borderless mind, which connects the past with the present. The idea is not to 'recreate' the past but 'understand' the past by using new science. TL Lentz and colleagues reported in 1982 in Science that acetylcholine receptors might serve as receptors for rabies virus. In Sushruta Samhita, the ancient Indian classic on the science of life, there is a fascinating account of Datura as a prophylaxis for rabies. The active principles of Datura Strammonium are atropine and related alkaloids that predominantly block the muscarine action of acetylcholine, precisely what was discovered by Lentz and others thousands of years later. In view of Lentz's findings, Datura for rabies may represent the first documented example of pro-phylaxis by receptor blockade. However, the use of Datura was found by people centuries ago, who were not trained in modern science. On the other hand, modern scientists had no clue about the work reported in Sushruta Samhita. How do we build the bridges between the two? ]]> <![CDATA[adVenture of Strand Genomics]]> https://biospectrumindia.com/news/95/2722/adventure-of-strand-genomics.html https://biospectrumindia.com/news/95/2722/adventure-of-strand-genomics.html Mon, 10 Feb 2003 18:34:00 +0530 The 'four strands' of the prestigious Indian Institute of Science (IISc.), Bangalore, have varied interests in the fields like network protocols, combinatorial algorithms, computational biology, logic programming, sequence analysis, string algorithms, computational geometry, virtual reality and graphics. They joined hands for a project when the bio-informatics industry is taking negative path in USA and Europe. Even before the completion of the project the strands of IISc floated a new venture with Silicon Valley of India in the field of bio informatics. Strand Genomics, the first bio-informatics company in India started in November 2000, is a biosciences knowledge management company. It was started with a serious commitment to develop innovative algorithms and solutions in the area of bio-informatics.  Strand's journey Seen in picture are (L-R) Prof. Vijay Chandru,  Prof. Swami Manohar, Prof. V Vinay,  Prof. Ramesh Hariharan and Dr S Seshadri As mainstream computer scientists, the founders of Strand Genomics namely Prof. Vijay Chandru, Prof. Ramesh Hariharan, Prof. Swami Manohar and Prof. V Vinay working on different projects at IISc., were interested in the life science informatics area during 1993-94. The zeal to learn and understand the subject has made them to approach the Department of Biotechnology(DBT), as an intellectual enterprise, in the mid Nineties. The group of four then started organizing seminars and workshops in computational biology where they interacted with biologists from around India and the US.  â€œIt is the excitement of the human genome project and in general the transduction of many biological properties to transform inferential thinking in the life sciences to â€œknowledge managementâ€? problems in computer science were perhaps motivated us to look keenly into this sector. And it became clear to us that in the long term, life sciences would be the driving application domain to push the frontiers of computer science,â€? says Prof. Vijay Chandru, co-founder and now the chairman of Strand Genomics, when asked about the motivation factors that boosted their confidence to start the first bio-informatics company in the country.  However this was really quite different from the motivation behind bio-informatics programs of Government of India (primarily DBT) that initiated the bio-informatics program way back in 1986. The DBT had been focusing more as service-oriented support for research biologists in the country. The Strands' entrepreneurial interest in bio-informatics was sparked in 1999 when the group began working with Genomics Collaborative Inc.(GCI), a US based firm, on a funded project towards the perceptual computing laboratory(PCL)at IISc. It took another year for IISc to put together the framework for faculty entrepreneurship. Finally Strand Genomics started up in October 2000. About the bonding among the four, Prof. Chandru, who is instrumental in Strand says, â€œI had collaborated with Vinay in the late 1980's (on problems in theoretical computer science) when I was working as a professor at Purdue University in the US and he was a PhD student at IISc. Manohar and I began collaboration (in geometric modeling and CAD/CAM) in 1992 when I returned from Purdue and took up a position at IISc. It was officially in 1994 that Vinay, Manohar and I started working together in the Virtual prototyping Lab at IISc. Hariharan joined us in late 1995 and the lab was reborn in 1996 at the PCL. In 1997-1998 we worked on a project with Satyam on natural language processing that gave the lab excellent initial momentum and from then on we haven't looked back.â€? Dr S Seshadri, CEO , Strand Genomcis, too joined the founding team in March 2001 (five months after it was started). But he was in touch with Strand even before joining the team. Prof. Chandru says, â€œas a former professor of IIT-Powai, Dr Seshadri certainly shared our philosophy and vision. As an outstanding computer scientist, he added certain talents to the group that made us a more complete informatics company. As someone who had moved to industry and had served as chief technical officer of a large corporate like Lucent Network Management, he brought a certain professional management and corporate structuring into Strand at a very early stage.  With these things at the backdrop for all practical purposes he is also a founder of Strand. Even the share holders agreement officially lists him as a founder also.â€?  Hallucination of visionaries The group had a clear focus when they became the part of Strand Genomics, as founder members. The vision was to design and construct the ultimate computing platform for life sciences. They all called this vision as Oyster. This vision fits well with in their business model of customized services and tools for global bio-pharma. The customized solutions helped the group to start putting together the tools that are the components of Oyster. As the toolkit expands, Strand is in a position to provide a variety of customized solutions.  The GCI funded project ended in December 2001. By then the group was already engaged in working with Syrrx, a San Diego based biotechnology company involved in shaping the drug discovery on image analysis. The work on data mining was also underway with a couple of customers. The micro-array suite was also being conceptualized and designed.  However the main challenges being faced during the initial stages were fund raising, learning the ropes as first time entrepreneurs, dealing with the challenge of addressing the domain of life sciences with a team that had unquestionable expertise in computing but unproven talent in the life sciences.  Strand's menology  1999 Strands' entrepreneurial interest in bio-informatics sparks off November 2000 Strand Genomics became the first bio-informatics company in India December 2001 The Strand team completes Genomics Collaborative Inc.(GCI), a US based company  funded project  Strand licenses Sphatika exclusively to Syrrx Inc. April 2002 Strand launches Soochika, knowledge management tool July 2002 Strand nominated as the technology pioneer of the World Economic Forum  September 2002 WestBridge capital partners completes first round of funding of $4.6 million  Realizing the dream In a short span of just two years the Strand was able to stand on the top. Attracted by its activities, angel and venture capitalists like WestBridge Capital Partners, a US-India venture capital firm with $140 million under management, completed the first round of funding of $4.6 million. Without disappointing them, the Strand's team comprising of a blend of computer scientists and scientists with expertise in life sciences came out with three products. The products include Sphatika, Sarani and Soochika. Out of the three, Strand has already got the provisional patent for the first two products.  Sphatika is Strand's first product developed in three months. It is an image analysis software, which automates the monitoring of high throughput protein crystallization experiments. It will play a critical role in monitoring the industrial scale protein crystallization experiments without manual intervention. Strand licensed the Sphatika, software for image classification on an exclusive basis to San Diego based Syrrx Inc on 18 December 2001. In the last year Strand has launched two more products namely Sarani and Soochika.  Sarani is unique Oligo design software designed in collaboration with industry experts. The product allows for extensive modelling of cross hybridization and surface charge effects, thereby addressing some of the key issues facing the microarray industry. Besides, Strand has released 1.0 version of the Soochika. This knowledge management tool will allow researchers and scientists in the biotechnology and the pharmaceutical industry as well as university research labs to analyze complex microarray data and infer trends in gene expression. Soochika was short listed as a finalist for the industry's first life science technology 'Best of Show' awards in support application category announced by Bio-IT World magazine and international data group(IDG) World Expo in November 2002. Besides these key products, the Strand has developed sequence analysis tools for mining deoxyribo nucleicacid (DNA) and protein sequences. Having the vision to accelerate the drug discovery and development cycle by developing Oyster, Prof. Vinay , lead the team that developed Manjara search engine, patented by Yale university. Strand's business  Strand has established its brand in the market. This can be viewed from its clientele base, which include Syngene and Clinigene (both the subsidiaries of Biocon India Group), Syrrx Inc, Genomics USA, Abgenix and Sequenom. Prof. Chandru says, â€œDiscussions are under way for partnerships with global pharmaceutical and biotechnology companies. Besides, the company is also keen on working together on offshore services solutions from over 15 global pharmaceutical and biotechnology--product and tool--companies.â€? On future of Strand  Speaking about the product market for the Strand, Prof. Chandru says, â€œThe markets for our solutions and products will be largely outside India in the next two to three years. Within India we will largely work on collaborations with companies, research labs and universities to validate hone our products and more importantly to collaboratively create intellectual property that realizes value in the global markets. â€? Inspite of doing well in a brief stint of two years, Strand might struggle in near future as it has already completed the first round of funding of $4.6 million from West Bridge. Confidently Prof. Chandru says, â€œIn the next couple of years we have to generate revenue from our technology and skill base. Additional funding is not critical but opportunistic at this stage.â€? This is mainly because 80 percent of the action in bio-pharma is in the US and its networks are primarily US centric as well. Prof. Chandru feels that Indian bio-pharma is still in an immature stage as far as data driven drug discovery and development are concerned and the proposition that Strand has to offer to improve efficiencies of drug discovery and development are not valuable at this stage to Indian bio-pharma sector. However, making use of the best talent, expertise and utilizing the opportunity at the right time, Strand has established itself in the new field of bio-informatics in India. Narayan Kulkarni   ]]> <![CDATA[The Biotech Park for Women: it's different]]> https://biospectrumindia.com/news/95/2745/the-biotech-park-for-women-its-different.html https://biospectrumindia.com/news/95/2745/the-biotech-park-for-women-its-different.html Mon, 10 Feb 2003 18:34:00 +0530 The announcement of the human genome sequence and the strides made in genetic engineering has made biotechnology as the next knowledge-based industry. The government of Tamil Nadu, which ranks second in software exports is now all geared to meet the new wave by setting up bio-valleys in the state. The state is already ready with five bio-valleys ---Biotechnology Incubator Park, Golden Jubilee Biotech Park for Women Society, Bioinformatics and Genomics Center, Marine Biotechnology Park and Medical Plants Biotechnology Park.  The Golden Jubilee Biotech Park for Women Society is the first Biotech Park for women in India, was started with the mission â€œto provide opportunities for professionally qualified women to take to a career of remunerative self-employment through the organization of environment friendly biotechnological enterprises.â€?  The seed for such a park was laid in 1996 at a meeting of women scientists and technologists. This meeting was organized by United Nations Development Program-United Nations Development Fund for Women ( UNDP-UNIFEM) and MS Swaminathan Research Foundation (MSSRF) in Chennai. This was also recognized as one of the priority areas identified by the department of biotechnology (DBT), government of India, in the report of the working group for the formulation of the ninth five-year plan (1997-02). The Park was included among the approved programs for commemorating the Golden Jubilee celebration of India's independence, hence the name The Golden Jubilee Biotech Park for Women Society.  The government of Tamil Nadu has supported this endeavor by allotting 20 acres of land in Siruseri Village, just 25 kms from Chennai, inside SIPCOT-IT Park. The park which commenced commercial operations in May 2001 is designed based on the principle of decentralized production supported by appropriate centralized services to promote a series of biotechnology based enterprises to capture niche markets like - agro, food & nutrition, medical & healthcare, environment & energy. â€œWhen the park was conceptualized in 1996 we got nearly 200 applications from women entrepreneurs. Actually I was one among the first to register as an entrepreneur. But over the period many of them dropped out with reasons of marriage and children. Currently there are seven entrepreneurs and 20 sheds available in the park,â€?says Dr Sucharita Kumar, an entrepreneur at the park. Subsequently, she has become the CEO of the park too. The park offers pre-built industrial sheds designed to suit various types of industrial sheds designed to suit various types of industries. The sheds are of 1,000 sq ft each in 2,800 sq ft of land. The sheds are available for a monthly rent of Rs 5,000 per month. In addition to this the park also offers on long and short-term lease, land modules for building factories or to set up agro-biotechnology activities.  â€œOpportunities for women in India is very limited. The self-employment of women will give them social empowerment. In this park we are trying out some unique initiatives rather than giving them out just sheds. We want to capture the niche markets like agro, cosmetics, healthcare, food and nutrition etc. The attempt is to connect the rural women with the urban,â€? Dr Sucharitha observed. Though the entire project seems good but there are many obstacles in materializing it. â€œIt takes nearly a years time to identify an entrepreneur. The greatest lies in motivating these people to undertake a project and go forward. Moreover they are not willing to take risk with regard to money. The venture capitalists (VC's) talk of funding but not for people at the lower level. We had taken this issue with the DBT to ask the VCs to fund for people with lesser financial background,â€? says Dr Sucharita. Marketing forms 90 percent of the hurdle. So the group at the park have decided to sell the park as a whole and not their product alone. â€œWherever an entrepreneur will go she will not sell her product but the park entirely. Here our whole idea is not to look at the other entrepreneur as a competitor but everyone here is to add value to the other,â€? she added. Green Galore This is a unit at the biotech park, which makes sambar and rasam powder but with healthy herbs. The unit called foodgrafts hcerbalinc has branded its product as Green Galore and a packet of 100 gms costs Rs 20. The traditional Indian sambar and rasam powder has been fortified with the inclusion of herbs. So a Green Galore rasam packet will have in addition herbal products like dry ginger, long pepper, eclita and amla. This according to the unit people will have additional percentage of calcium, carotene , and vitamin-A. The unit was started some four months back and is being run by Vijaylakshmi. The products are available only in the super market and not in the open markets.  Bio-Controls Elbitec Innovations Ltd is a registered office at the biotech park run by Dr Bama. The products developed here are eco-friendly natural organic bio-inputs for applications in sugarcane, cotton, cereals, pulses, coffee, tea, vegetables & fruits, nuts & oil seeds, spices & herbs etc. The bio-inputs when applied together, as a program is believed to increase the yield, taste and also increases the shelf life of the produce. Added to that it reduces the irrigation, chemical fertilizers and chemical pesticides expenses. Elbitec range of products works on the principle of potency effectiveness and self-multiplication.  Bio-Food The biotech park will soon be equipped with a food-testing lab. Interspice Biotech Private Ltd of the BK Group has entered into a tie-up with a UK-based company called RSSL to set up a food testing-lab in the biotech park, which will be called Center for Research and Applied Food Technology (CRAFT ). CRAFT will become operational from April this year.  Interspice has already an R&D lab inside the park. Besides the company is importing lactic acid from Belgium-based company called Galactic. Lactic acid is a preservative used in food, pharmaceuticals and industrial applications.  Tex Bio Tech Opened very recently at the Park is Tex Bio Tech a group concern of Textan Chemicals (P) Ltd. It manufactures biotech specialty products for the leather, textile, paper, poultry and pharmaceutical industry.  Dream Finders You want to have care for your hair. Dream Finders, occupying shed No: 10 in the park has launched from Malaysia 'Silk Coatz', treatment for the hair with vitamins and proteins, which gives treatment for dry hair, split end and hair damages. 160 mls of the bottle costs Rs 391.  Foot Notez is yet another product from Dream Finders. It is a pedicure biocleaner with organic sulphur, neem and lime extracts.  Nisha Kurian, Cyber News Service ]]> <![CDATA[Biotechnology: The Choice for Your Future]]> https://biospectrumindia.com/news/95/2895/biotechnology-the-choice-for-your-future.html https://biospectrumindia.com/news/95/2895/biotechnology-the-choice-for-your-future.html Mon, 10 Feb 2003 18:34:00 +0530 The Indian biotechnology industry currently employs about 10,000 and this figure is expected to double in the near future. Other than the domestic demand there is also a high demand for human resources in the international market. The international community is aware of Indian skills. The country has trained and supplied high quality human resources and scientists for US universities and biotech industry, who are the world leader in the research, development and commercialization of biotechnology products.  Because biotechnology essentially uses the basic ingredients of life to make new products, it is both a cutting-edge technology and an applied science. Its application can be used in any industrial sector that works to improve the quality of life such as to produce modified crop plants, livestock, proteins, vaccines, and drugs. So the scope of career opportunities in biotech-related fields is tremendous.  Many Indian companies has already ventured into the different fields of biotechnology such as bio-informatics, biopharmaceutical, bio-agriculture, human genetics and genome analysis, vaccine research and development, etc. The job opportunities could range from research and development to production and marketing.  â€œThe beauty about biotechnology industry is that it has multifaceted recruitment unlike software industry, which needs only homogenous skill,â€? says Kiran Mazumdar Shah of Biocon, the leaders in Indian biotech industry. There is an enormous career opportunity here right from microbiology to chemical engineering, from mathematical computational modelling to software development, from regulating to patenting. â€œToday one can focus just on biotechnology patents. If you are a good lawyer and have a background in scientific knowledge you can become a very good patent attorney. A company like ours has biologists, chemists, genetic scientists, microbiologists, mechanical engineers, chemical engineers, electrical engineers, regulatory people, doctors, lawyers and so on. This shows the huge potential of the industry in generating various kinds of jobs.â€?  To prepare for a career in biotechnology, a person should have a firm base in biology, chemistry, and other life sciences. Post graduation, doctoral qualification in biotechnology offered by universities and other institutions can lead to placements in the research laboratories run by government and corporate sector other than those avenues in the industry. The multinational companies, with the pharmaceutical and chemical industry in close lead, offer the best remuneration packages. With a number of companies launching foray into biotech industry, the business is growing at an accelerated rate. And the compensation is too competitive in comparison with software industry and includes incentives, such as stock option plans, company-wide stock purchase plans, and cash bonus plans. Bioinformatics Bio-informatics is perhaps the hottest area in the biotechnology world. An acronym for biological informatics, it is an integral component of this new science. It is the application of computation to the field of biology. Further elaborated as a science of collecting, storing, searching, annotating, modeling and analyzing biological information, that involves a range of activities from data handling, publication to data mining and analysis.  Estimates say that there is a global shortage of one million professionals in bio-informatics. This shows the tremendous scope in this particular field alone. And the presence of a world-class software industry in India keeps the country on a brighter side for global investors in bio-informatics.  The Department of Biotechnology under the Ministry of Science and Technology, Government of India has taken a lead R&D of this sector. Significant funds have been granted to universities and informatics networks for it. Tata Consultancy Services (TCS) has been assigned to develop an integral software package for bioinformatics, with the support of 18 institutions under the Council of Scientific and Industrial Research (CSIR).  Many of the leading biotech firms have started tying up with leading institutions to train people in this field. Ocimum Biosolutions, one such company dealing with bioinformatics solutions, offers six months training programme in partnership with the Michigam Technological University. â€œThis is rather rigorous course and only about 10-15 students are selected for training. We absorb about 40 per cent of them in-house,â€? says Anuradha Acharya, CEO, Ocimum Biosolutions. â€œWe have placed almost all our students in India and abroad,â€? adds she.  Sys Arris Software Private Ltd, a leading software solution provider for the life sciences industry is to set up a centre of excellence for bio-informatics at PES College of Pharmacy, Bangalore. â€œThe centre of excellence will help M. Pharm students to get exposure to the industry needs and will make learning more effective,â€? says Prof. MR Doreswamy, Founder Secretary of PES institutions.   â€œIt is very much important to get the right kind of training if one wants to really succeed in this field,â€? says Anuradha Acharya, CEO, Ocimum Biosolutions Biotechnology should be an important component of biotechnology education. It has far wider scope that it is now projected. But it should be looked at with a clear perspective. â€œWe should see bioinformatics as the domain of biology and not of information technology,â€? says Dr Seetharam Annadana, coordinator of Wagningan University, Netherlands, in India. The university offers online courses in a) Recombinent DNA technology b) Bioinofrmatics 3) Process engineering with special emphasis on R&D and genomics. The Wet Laboratory at the St. Josephs Institute of Gene Technology provides practical training for the students doing the courses.  Bio informatics as a field of study is becoming increasingly important due to its role in genome sequencing projects in the biotechnology sector. This leads it shrouded in a lot of hype concealing the ground realities in the field. This has led to the mushrooming of educational institutions in this field, as happened in the software. Most of the big companies in the industry, both in the government and corporate sector, complaints about the ill-trained graduates coming out of these institutions. â€œMany people claim to have done some course or the other, but most of them don't have a grip on the subject,â€? says Anuradha Acharya. She says that there is always a dearth of talented professionals in this informatics area. â€œIt is very much important to get the right kind of training if one wants to really succeed in this field,â€? she adds. A curriculum needs to be developed keeping in mind the needs of the industry.  Biopharmaceuticals India has a vibrant pharmaceutical sector in the country. â€œBio-pharma has a very important role to play and that is going to be the highest growth area,â€? says Kiran Mazumadar whose main focus is into pharmaceutics. Success stories in the sector has forced pharma majors including Dr Reddy's Lab. and Ranbaxy to foray into the field. The bio-pharma products are becoming the most powerful pharmaceutical agents for some of the deadliest genetically linked diseases and cancers.   The worldwide pharmaceutical market is expected to reach US $3 trillion by 2020, which was $317 billion in 2000. It is obvious that the biotechnology in the health sector is a serious industry and not just hype. It is knowledge based industry and the complexion keeps changing with newer break through, giving lot of job opportunities. Wockhardt, Ranbaxy, Shantha biotech and Biocon are the leading companies in the Indian industry.   "We need to have more training centres like IITs,â€? says Varaprasad Reddy, managing director , Shantha Biotech, Hyderbad. According to Kiran mazumdar India with its scientific manpower has a vital role for global success in biotechnology and pharmaceutical R&D. However we need to harness this talent in an enabling business environment with a pragmatic, entrepreneurial mindset. â€œStudents passing out from our institutions and universities lack practical training as most of the institutions don't have proper infrastructure. We need to have more training centres like IITs,â€? says Varaprasad Reddy, managing director , Shantha Biotech, Hyderbad. Shantha Biotech, which mainly focuses on research and development in the bio-pharma sector, has about 394 employees. The company trains the new comers to improve in technical aspects and also in improving the soft skills.  Bioagriculture  Agriculture is another key area that Indian biotech industry is looking at. The country offers a huge market for agribiotech products, as India's economy is still heavily dependent on agriculture. This, combined with excellent scientific infrastructure in agriculture, rich bio-diversity and skilled and low cost human-power, makes it a haven for investments. Also, the increasing productivity on the existing land becomes essential in order to ensure future food security for the growing population. â€œBioagri is a boon to the country to fulfil its domestic requirements in food grain sector,â€? comments Krishnappa, vice-chancellor, University of Agricultural Science, Bangalore. The university has got a department dealing with biotechnology and presently 16 students are pursuing the biotechnology course at the department. Though there is demand from the student community to increase the number of seats, lack of infrastructure does not allow this. â€œIt is difficult to run the show due to lack of funds and support from the government,â€? says the vice chancellor.  The transgenic technology has recently attracted attention with the approval of Bt-cotton. High yielding genetically modified (GM) pest resistant crops would give a new lease of life to the suffering farmers. The scope of job opportunities in agri-biotech is also growing with the industry. The skilled manpower that required in this sector is more than in any other sector. â€œWhenever there is a need of intellectual labour in international market, the global market looks at Indians,â€? says Deepak Mallik, CEO, Advanta India Ltd, which is into agri-biotech.  The scope of biotechnology related fields are not complete with these sectors. But there is a dearth for well-trained professionals in this multidisciplinary field. There are a number of universities and other autonomous institutions coming out with various courses to meet this need. But it has got a negative side. â€œThere is a serious problem with the mushrooming of institutions in biotechnology,â€? says Kiran Mazumdar. â€œEducation is very important and if the correct type of education is not provided that will seriously impact on the quality of people coming out of this institutions,â€? she says. She suggests that there is a lack of teachers in the field. The government should first allocate a budget to train teachers in the field rather than announcing new colleges and courses. â€œEven the first rank holder of a university when interviewed doesn't know the differences between yeast and a fungus. This is the kind of standard that our students have,â€? she comments. So if you are serious about a career in the science of the century you can make a choice of Biotechnology. So if you are serious about a career with the new science of the century, take up a course, which has a syllabus in tune with the industry standards like IBAB. â€œThey give a good training to students. We are absorbing some of their students through campus recruitment,â€? said Kiran Mazumdar.  Roby Ajith ]]> <![CDATA[Biotech Visionary]]> https://biospectrumindia.com/news/95/3102/biotech-visionary.html https://biospectrumindia.com/news/95/3102/biotech-visionary.html Mon, 10 Feb 2003 18:34:00 +0530 Strong determination and one lakh rupees were all that Kiran Mazumdar Shaw had with her when she entered into a joint venture with Biocon, an Irish company, to manufacture enzymes. Biocon, the country's biggest biotech company, had humble beginning at Shaw's garage in Bangalore in 1978. Later, she shifted to a small house, on rent, in Koramangala, a suburb Bangalore where she set up her business unit. Her Irish collaborators were ready to support her with whatever she wanted, but her pride didn't allow her to take help. She wanted to build the company with her own bare hands. Her zest to succeed has today brought her to the forefront of India's booming biotechnology business. After 25 years of existence, the Bangalore-based Biocon India Group has today grown to a Rs180 crore major in the fledging field of biotech. The company, which is growing much faster than the rest in the industry, has projected a turnover of Rs 280 crore for the fiscal 2002-2003. The company is making rapid inroads into the US statins (cholesterol-lowering drugs) market. It is perhaps the first Indian company to get approval in the US to use solid-state fermentation for manufacturing statins, a group of cholesterol-lowering drugs. The latest news about Biocon having captured 10 percent of the US cholesterol lowering drug market with Lovastatin, in less than six months of its launch, is yet another feather on its cap. They are aiming at 25 percent market share by the end of next year. Biocon Group and Shaw have many success stories to their credit. The Biocon Group's Research and Development (R&D) and manufacturing facilities received ISO-9001 certification in 1993. In March 2001, their proprietary bioreactor, the PlaFractorTM was granted the US and worldwide patent. The group has also played an important role in the formulation of a biotechnology policy of Karnataka. Shaw is the first woman in the country to step into the field of brewing and industrial enzymes. She is also the first woman to be appointed the Honorary Consul of Ireland. Shaw has won almost every recognition awarded for entrepreneurship in the country. She was conferred the prestigious Padmashri award in 1989 and the Rotary Award for Best Model Employer. She has been recognised for her significant achievements as an industrialist and for her contribution to the society with M Visweswariah Award in 2002. Kiran never even dreamt of being an entrepreneur. Her childhood ambition was to become a doctor. In those days most opportunities existed either in engineering or in the medical field and she was very keen to join the medical profession. Unable to secure admission to a medical college, she was forced to do Zoology honors at Bangalore University. By the time she completed her honors degree, she realized that medicine was something that could not be gained without spending around five years for that. And she was not ready to waste another five years and made up her mind to pursue a career in some other field of science. Her father, who was a brewer, influenced her to take up fermentation science and pursue brewing as a career. She went to Australia for doing master's degree in brewing at Ballarat College, Melbourne University. After completing her studies in malting and brewing, she came back to India and practiced her profession for a few years in Calcutta, Mumbai, and Bangalore. Kiran, along with her father, worked as a consultant for breweries in all these cities before setting up her own business in Bangalore. After the humble beginning in Koramangala, her company acquired 20 acres of land for Rs12 lakhs in 1980 and moved operations to the place where it is presently located. The completion of the construction works took three years. That was the first big step for Biocon. Today, Biocon India Group has a contract research subsidiary Syngene. Established in 1994, Syngene has garnered experience and expertise in providing customized R&D services to the pharma and biotech sectors on a strong platform of confidentiality and intellectual property protection. The company is the first Indian biotech Contract Research Organisation (CRO) to be granted special export status by the Government of India. With state-of- the-art facilities, dedicated connectivity and experienced researchers, Syngene International offers its customers a powerful, cost-competitive edge in the field of outsourced R&D. Clinegene is Biocon's clinical research subsidiary established in 2000. Clinegene aims to advance medical wisdom through well-defined clinical studies in select disease segments. It works closely with specialized clinics to create large analytical databases that dovetail with the data-mining capabilities at Syngene. Employing this bio-informatics platform, Syngene endeavors to identify new biomarkers that will eventually result in proprietary diagnostics and therapies. As a woman achiever, Kiran Mazumdar Shaw is far ahead of others. Her story illustrates the classic model of entrepreneurial spirit. Surefooted and confident, she aims at becoming a biotechnology expert of global reputation. Biocon has already attained global recognition biotechnology market. In insulin manufacturing, it is already in the top 10. Shaw dreams of seeing Biocon in the top 10 global companies in the next few years. â€œIf Biocon figures in the top ten companies in the world, that will be everything for me,â€? concludes Shaw. â€œWhatever I do, I do it with a lot of seriousness and with a very determined mind to succeedâ€? In a conversation with Roby Ajith of BioSpectrum, Shaw detailed the hardwork that went into making Biocon what it is today and also how she achieved the status of a celebrity entrepreneur. Q. Educated in Australia, you could have joined any multi-national company abroad. What made you return to India? A. I was not keen on taking up a job abroad, because I felt that there was a big opportunity for brewers in India. And I was eager to come back and grab it. But on reaching here, I realized the strong stigma of actually being a woman in brewing. Most of the companies were willing to let me do a lot of trouble shooting for them, and they were happy to call me whenever they had problems while commissioning projects. But none of them had the courage to entrust me with their breweries as a full-fledged manager just because they felt that being a woman I had lot of disadvantages. Lot of the companies had unions and they asked me, â€œhow will you manage unions?â€? Also, work at breweries is such that you have to come in at all hours for something or the other. In those days, few women were in business and I had a tough time trying to prove myself. Q. How did you feel when you got a chance to venture into a business? A. I was initially quite diffident when I got the opportunity to set up Biocon. In fact, I was telling my collaborators, â€œI don't know why you are asking me to get in to a joint venture with you. First of all, I am a woman; I don't have an MBA and in addition, I don't even have the money to set up a company.â€? The answer was this â€œWe are looking for somebody with a lot of initiative and a challenging spirit. We are sure that you will make a success of this company.â€? They had more faith in me than myself. I took it as a challenge. Whatever I do, I do it with a lot of seriousness and with a very determined mind to succeed and that is what you require when you do anything. There has to be determination and a sense of challenge, if you want to succeed. With that in my mind, I set up Biocon when I was 25 years old. Second, I had no experience running any business. Fortunately, I had some experience in working with companies, certain projects. So I knew what it was to manage activities and how to plan out an operation. Nevertheless, when you are doing your own business it is a very different challenge. It was a good opening. Biocon became the first Indian biotechnology company. In 1979, Biocon started exporting its products. In 1990, Biocon entered the pharmaceutical business. Q. Looking back to past 25 years, how do you feel? A. Biocon's is an exciting history. Every year was a year of learning and a year of earning too. Growth has been exponential every year. A very rich experience for me is all the various passage that we have gone through and how successful we have been in each. Our subsidiaryis the largest contract research company in the country. Synegene has got very high profile internationally. In the enzyme sector, we look forward to become one among the top 10 companies in the world. Our pharmaceutical initiatives are gaining international importance. The pharmaceutical division is focusing on developing drugs for diabetic, cardiovascular diseases, and cancer. Q. You are known to be one of the best employers in the country. How do you keep your employees motivated? A. I believe that motivation is all about empowerment. In our case, we encourage employees to own a problem rather than owing a task. In Biocon, employees are encouraged to solve problems themselves. We have a flat organisational structure. Any one can walk to my door and speak to me. Gardener to president, all have equal access to me. The moment you start building boundaries, you destroy that open culture. We have generated a committed bunch of people who are empowered in the best working environment. Q. What are your initiatives for social and community development ? A. Our community instincts are quite strong. Biocon has contributed enormously to the development of health and education through building schools and sponsoring training programmes for teachers. We have built schools in Anekal, Gollhalli, Hoskur, and upgraded computers in the neighbourhood schools. We have also trained around 30 teachers to use them properly. Significant contributions have also been made in improving the health of the community. Around 6,000 children were vaccinated for both polio and hepatitis-B. Setting up of small medical centers is on the cards. We are committed to extending primary education and healthcare to the rural population. Q. How do you view the fast multifaceted industrial development of Bangalore? A. I am a Gujarati, born and brought up in Bangalore. I am very much Bangalorean and speak Kannada better than Gujarati. Grown up in Bangalore, I have seen it as a very clean, beautiful city with a soul. There are many things that make it so multi faceted other than IT or BT. The city has its own ethos -- theatre, food, music, academics, architecture etc. But I think all that is disappearing now. There is not enough public participation in improving civic amenities. Everyone thinks that there are others who are responsible. People don't find a sort of involvement in participating in civic kind of movement. Q. How do you fit family life into your busy schedule? A. That is the biggest problem for me. Luckily my husband and I work together. My mother is also a busy person, running her own business at the age of 72. However, I find time to dine with my mom every evening. My in-laws come over to India from Scotland for three months every year. Q. On getting awards A. Padmashree meant a lot to me. I was really shocked hearing about it. Initially I thought somebody was trying to fool me. It is a good recognition, a prestigious national honor. I was very thrilled that the government has really recognized my efforts in the very early days. The MV Memorial award is very special to me because I personally know Sir M Viswerswariah. He was a great man and a true visionary. Q. Your hobbies A. I am very fond of art and find time to visit art galleries and exhibitions. Being a trustee of Karnataka chitra kala parishath, I am involved in running all India artists camps and exhibitions. I also enjoy catching with friends. Roby Ajith ]]> <![CDATA[The Scope of Biotechnology: the Indian Advantage]]> https://biospectrumindia.com/news/95/6788/the-scope-of-biotechnology-the-indian-advantage.html https://biospectrumindia.com/news/95/6788/the-scope-of-biotechnology-the-indian-advantage.html Mon, 10 Feb 2003 18:34:00 +0530 Biotechnology may be as old as human civilization but modern biotechnology is less than three decades old. Traditional Biotechnology that led to the development of processes for producing products like yogurt, Vinegar, alcohol and cheese was entirely empirical and bereft of any understanding of the mechanisms that led to the product. There was no possibility of a deliberate design to produce a desired new product. In modern biotechnology, we use the in- depth understanding we have gained in the last five decades. The mechanisms that underlie the variety of functions performed by living organisms, to produce a desired new or old product. In the case of an established product, the new biotechnological process is cheaper and better in many respects than the earlier processes. Modern biotechnology has been, infact, an historical imperative. Its emergence on the world scene was predicted at least four decades ago. The term, genetic engineering, was coined independently in 1973 by the author of an article in The Guardian in the UK, and in a syndicated article by the present author in India. Pushpa M. Bhargava, one of India's most brilliant scientists, has founded  and directed the Centre for Cellular and Molecular Biology (CCMB), Hyderabad.His scientific contributions include the preparation and characterization of primary lever cell suspensions, identification of proteins from the seminal plasma and extensive characterization of one of these proteins and seminal plasmin. He has been awarded with Padma Bhushan, the Legion d' Honneur, the Wattumul Memorial Prize and Goyal Prize. Today's biotechnology consists of at least twenty-five areas each area being characterized by the use of a different set of technologies. Scope of Biotechnology Genetic engineering: Genetic Engineering of microbes, plants and animals (including marine animals). Genetic engineering implies conferring new capabilities on an organism by Transferring into an organism the appropriate DNA (De oxyribo Nucleic Acid, the genetic material) of another having these capabilities does this. Then ensures that these capabilities are converted into abilities. Thus the common yeast, Sacchromyces cerevisciae cannot make the protein, human insulin, but we can make it to do so by introducing in it the gene for human insulin (that is, the appropriate DNA fragment coding for this protein). After integrating the insulin gene in yeast DNA, creates condition for the insulin to express itself to produce insulin through the normal process of transfer of information from DNA to protein. Genetically engineered microbes are today widely used for producing drugs and vaccines in large scale at low costs that are of great importance (human insulin, erythropoietin, and hepatitis-B vaccine). For example genetically engineered plants that make their own pesticides or are resistant to weedicides- are already in the market. Thus, over 60 percent of the acreage under soyabean in the United States have now genetically engineered soyabean that is resistant to the weedicides, Roundup. The total acreage under genetically engineered crops (for good or for bad) around the world exceeds 100 million acres today. Genetically engineering plants are also poised to produce vaccines. A few hundred acres of genetically engineered banana plantation can provide enough vaccine to immunize 120 million children every year that need to be protected against four common diseases. One of the future sources of cheap protein-drugs in the coming years, would be genetically engineered animals who would secrete these drugs in abundance (1-15 mg/ml) in their milk. They will be available at a cost of three or more times lower than the current cost. Gene Therapy: This is in a way, genetic engineering of humans, which would allow a person suffering from a disabling genetic disorder to lead a normal life. Immunotechnologies: Such as monoclonal antibodies (MABs) for diagnosis and therapy. Antibodies, special sets of proteins present in humans that enable them to fight incursion of their bodies by harmful chemicals or micro organisms. Monoclonal antibodies are single chemical species of antibodies produced in the laboratory by a special technique. Nobel Prize was awarded for this in the 1980's to Cesar Milstein and Georges Kashler. Mouse MAB's can be used for the diagnosis of human diseases. As human MABs are difficult to produce in the laboratory, genetically engineered plants are likely to find wide application in the production of human MABs. Sixty-percentage acreage under soyabean in US has now Genetically engineered soyabean. The total acreage under genetically engineered crops around the world exceeds 100 million acres today. Tissue culture: Tissue culture of both plant and animal cells. These are used for Micro propagation of elite or exotic materials (Such as orchids), production of useful compounds such as taxol (the widely used anti-cancer drug) and vanillin, and preparation in the laboratory of â€œnaturalâ€? tissues such as arteries for arterial graft or skin for burn victims. (Modern tissue culture technologies allow the multiplication in the laboratory of cells isolated from plants and animals. In the case of plants, one can grow in the lab a whole plant from a single cell.) Stem cell techniques: Which would involve purification and isolation of stem cells from various tissues and develop into the desired tissue which could then be used, for example, for transplantation. Stem cells can be either totipotent (have the capability to produce any desired cell type or organ of the body under specific conditions) or they could be pluripotent (able to develop into several though not all cell types or organs). As embryonic stem cells are more likely totipotency than stem cells from adult tissues, the immediate emphasis in the area of stem cells is going to be first in the direction of establishing cell lines derived from early human embryos, from which stem cells could be isolated. Enzyme engineering and technology: Involves immobilized or stabilized enzymes, new classes of enzymes (ribozymes) or new enzymatic routes that produce important organic compounds. Enzymes are biological catalysts (Generally proteins) poised to replace inorganic catalysts, which are used in chemical industry. (Proteins are abundant biological entities made up of twenty amino acids strung together like pearls in a necklace, by a special type of thread- a chemical bond called the peptide bond. One protein differs from another in the total number of amino acids and their sequence in the chain.) Photosynthetic efficiency: Increasing photosynthetic efficiency for biomass production in the plant with the same amount of light and other inputs. New DNA technologies: These include DNA fingerprinting, sequencing of genomes, development and use of new molecular markers for plant identification and characterization. Also the development of DNA- based probes for diagnosis of inherited disorders, antisense technologies that are aimed at blockage of the function of a particular stretch of DNA and computing using DNA. Plant-based drugs: Use of modern biological techniques for validation, standardization and manufacture of indigenous plant-based drug formulations. Peptide synthesis: Synthasis to make new drugs or other materials of industrial and commercial importance, such as salmon GnRH analogue (Ovaprim) to induce ovulation in fish. (Peptides are small proteins, generally containing less than 50 amino acid moieties.) The coming together of biotechnology and informatics is paying rich dividends. Genome projects, drug design and molecular taxonomy are all becoming increasingly dependent on informatics. Rational drug design: Until a decade or so ago, the only way to discover a new drug was to synthesize a large number of compounds hoping that one of them will be effective against a particular disease. And it cost something between half a billion to a billion dollars for bringing a new drug to the market. As a result we have not added more than ten new drugs per year to the repertoire of medicines already available. In rational drug design, we first identify the molecular target we wish to attack. To do so, it becomes necessary to understand the mechanism of causation of the disease. Once we understand this mechanism and identify the molecular target lead effective computerized programs to design a molecule, which would hit the target. This approach of designing a drug on a rational basis cuts the cost of discovery of a new and reduces the time required (Now 12-15 years) by half. Nutraceuticals: That helps recovery after surgery or an episode of a major disease, or helps protect one against certain medical and health problems. For example, a Swedish company, Probi, has isolated a strain of Lactobacillus planetarum, which is apparently present in the digestive tract of Europeans and Amercians. (Indians have not yet been tested for its presence). The presence of this organism has been correlated with the ability of the person to recover after major surgery or after chemotherapy of cancer; this organism also seems to protect people against a vast range of stomach disorders including stomach ulcerts, irritable bowel syndrome and constipation. Probi is, therefore, marketing this organism in various forms, including a delicious soft drink! Assisted reproductive technologies: Such as artificial insemination (Using husband's or donor semen), invitro fertilization, intra cytoplasmic sperm injection and techniques involving egg donation, surrogate motherhood or embryo transfer. New cloning technologies: - Cloning of genetically engineered animals that would produce useful products. Organ transplantation: Xenotransplantation that is transplantation into humans of organs from other animals. It appears that pig may be the most suitable for this biochemically, anatomically and immunologically. The major problem in xenotransplantation is the hyper-acute immunological rejection of the â€œ foreign organâ€? which occurs in a matter of minutes in enotrans plantation. This problem has been recently overcome by identifying the molecular basis of the hyper-acute rejection and then genetically engineering a pig to avoid it. But in the case of a kidney transplant from one human donor to another human recipient (homotransplantation) this does not occur.  New drug-delivery systems: Such as lipsomes and electrical patches, and the use of circadian rhythms to optimize the effectiveness of the drug. Thus the drug may depending on the circadian rhythm of the individual will be effective when taken at noon and midnight, than if taken at 6 AM and 6 PM. Production of useful materials: Existing (for example, polyunsaturated fatty acids or beta-carotene, both of which are essential for normal vision) or new, from so far unutilized or under utilized but widely available resources such as marine organisms. Production of new materials using new ideas: Observations or research findings, such as bacterial ropes or biodegradable polymers. For example, bacterial ropes that essentially consist of certain mutant bacteria that have the ability to grow into spagetti-like structures, when impregnated with certain metal ions can be stronger than steel but much lighter and biodegradable. DNA vaccines: Which would be much cheaper than protein antigen-based vaccines that are generally used today. New medical diagnostic technologies: - such as combination of MRI and Pet-SCAN for correlation of structure and function in normal and diseased individuals. Biosensor: For example, optical sensors using special thin films for detection of bacteria. Use of microbes:  Microbes selected or genetically engineered for effecting chemically difficult transformations, for example in the field of steroids that are widely used as drugs. Bioremediadtion: For example of effluents or waste, using biological systems. A septic tank and an oxidation pond are simple examples of such bioremediation. Production of biogas is value-added bioremediation! Processing of low-grade ores using microorganisms: Commercially viable bio processes are available today for processing such ores of over a dozen metals. Bioinformatics, including genomics and proteomics: This newly emerging area makes use of the enormous amount of data on biological systems that are becoming available. There are several million species known. The sequence of the building blocks of DNA of just one human being alone will fill nearly 700 books (typed single space) of 500 pages each. Nanobiotechnology: In which the operating or useful unit is of the scale of, say, a nanometre (millionth of a millimeter). The cost of products produced through a biotechnological process is always less than that produced through a chemical synthetic route. Biological warfare: This is defined as the 'employment of biological agents to produce casualties in man or animals or damage to plants. While a biological attack could result in a made-made epidemic of unprecedented scale, the classical principles of clinical medicine and epidemiology would apply. Prompt diagnosis and early interventions could reduce morbidity and mortality, and mitigate the effects of a biological attack. Advantages of biotechnologies Biotechnologies are always non-polluting and, often, labour intensive. They make use of replenishable natural resources and help their conservation. They help, directly or indirectly, in saving energy. The cost of products produced through a biotechnological process is almost always less than that of the same product product produced, say, through a chemical synthetic route. Biotechnologies are less accident-prone. In spite of their high level of intellectual sophistication, it is easier to train people to handle biotechnologies than other technologies. Above all, they are interesting and exciting for all those involved with them. The Indian advantage No other country in the world today has the unique set of advantages that India offers for large-scale practice of biotechnology. We have one of the largest bio in the world. We also have one of the largest coastlines anywhere. We have at least seven distinct climatic zones and one of the largest and most varied sets of marine organisms anywhere. The ambient temperature in most parts of the country is just what living organisms need for their activities that result in a biotechnological product. This curtails immensely the cost of cooling or heating which becomes obligatory for the practice of biotechnology in most parts of the Western world. There are places on the Indian coast where there is uninterrupted sunshine for some 340 days in the year so that one can grow marine organisms in open raceways. We have an enviable infrastructure and a large pool of trained manpower, with experience in most of the areas of biotechnology. Our labor and infrastructure costs are, perhaps, lower than anywhere else where biotechnology can be done and is being done, with the possible exception of China. We have large tracts of land available for growing the desired plants required for agriculture-based biotechnology. We have experience of building world-class institutions in virtually every sector of human endeavor â€“ from outstanding basic research to efficient industrial production. We have, of course, many problems but we also know how to overcome them. In a nutshell the advantages far outweigh the disadvantages. It is a pity that we started much later in biotechnology than we could have but, even now, the prospects for the future are bright. Dr. P.M. Bhargava ]]> <![CDATA[Mustard maker Awaits his Day]]> https://biospectrumindia.com/news/95/5939/mustard-maker-awaits-his-day.html https://biospectrumindia.com/news/95/5939/mustard-maker-awaits-his-day.html Mon, 10 Feb 2003 17:36:00 +0530 Proagro is on tenterhooks. For months now the Genetic Engineering Approval Committee (GEAC) of the Ministry of Environment and Forests has held up the decision to grant commercial approval to the transgenic mustard hybrid varieties that the company has developed. Even in its last meeting, held in December 2002, the committee decided to take more time to study the environmental and health safety factors of the transgenic mustard. But Proagro, a subsidiary of Bayer Crop Science Group, is confident that GEAC will grant its approval, though it is likely to lay down strict conditions. â€œIf everything goes well, we can go commercial by 2004,â€? says Proagro, director (research),Dr Paresh Verma. The company has spent eight years and Rs 5 crore to develop three hybrids of mustard plant using the transgenic method. Proagro's transgenic mustard ran into trouble when some members of the GEAC expressed their apprehension that the herbicide-resistant Bargene used to produce the Genetically Modified (GM) mustard hybrids would lead to aggravated weed problems. Allying such fears, Dr Verma, who has been leading the research on GM mustard at the company's headquarters and main research station in suburban Gurgaon, said, â€œFarmers will have absolutely no problem as the GM mustard will not lead to any weed problems. They can manually pull out the weeds as they normally do with their mustard crop.â€? For Proagro, GM Mustard is its first foray into transgenics. It is more of a plant breeding company developing hi-yield hybrids for rice, corn, soybean, sunflower, sorghum, cotton and millet. It has three more R&D stations at Aurangabad, Hyderabad and Bangalore, other than the one attached to its corporate headquarters in Gurgaon. It has about 35 agricultural scientists working on hybrid crops with an annual R&D investment of Rs 7 crore. Using the transgenic approach, Proagro developed a hybridisation technique to produce three hybrid varieties of mustardâ€”MT 95002, MT95003 and MT95005. â€œNatural hybrids of mustards are not commercially viable and we developed hybrids using transgenics to produce hi-yield varieties,â€? Dr Verma explained. Proagro has used two genes, Barnase and Barstar, to formulate the GM Mustard. Barnase has been used in the female and Barstar in the male to ensure that self-pollination does not occur. An additional gene, Bargene, has been used in the male as a marker. This gene is resistant to the herbicide, glufoscinate ammonium. â€œIn all transgenic varieties, we need to have a screening tool to follow the genes. The Bargene in these hybrids has been used only as a marker and its herbicide-resistance will not increase weeds,â€? explained Dr Verma.  Proagro first presented its GM mustard hybrid to the Royal Commission on Genetic Modification (RCGM) in 2000 after it completed bio-safety studies on food, environment, health and agronomic aspects. Once RCGM had given Proagro's GM mustard a positive review, the company approached GEAC in 2001 for approval. GEAC asked the company to go in for additional trials on environmental and agronomic fronts. It also asked for large-scale field trials. â€œWe held trials in farmlands under strict government supervision, in 50 locations across five states,â€? Dr Verma said.  This data was presented to the GEAC, which asked for further studies on the environmental and agronomic safety factors. â€œOur studies have shown that GM mustard is as safe as non GM mustard; it has no allergenic potential, there is no change in the nutritional value and there is no dermal or oral toxicity,â€? Dr Verma said, confidently. However, GAEC's biggest trepidation is that the pollination impact of GM mustard may be devastating, if it is not properly studied, as are more than 3,000 varieties of Indian mustard. After the last GEAC meeting, an official statement issued said, â€œGM mustard is being seen as a more complex issue than Bt cotton, given the biology of the mustard plant and the larger number of species in the mustard family.  The pollination impacts of GM mustard on the related and unrelated plant species have to be looked into rigorously.â€? The GAEC felt that the genes could escape into the soil bacteria and genetically pollute other species of mustard. The committee also raised the issue of pollen flow from GM mustard to non-GM mustard plants, longer duration of the GM hybrids, and food safety studies using the leaves of GM mustard hybrids. â€œOur studies have shown that these fears are baseless. The pollen overflow studies have shown that cross-pollination up to 10 mts was a mere 0.12 percent and beyond 10mts, it was 0.01 percent up to a maximum of 35 mts,â€? Dr Verma emphasised. He said these studies were done under the supervision of local district and state agricultural committees in two locations.  The delay in the commercial release of GM mustard should not be taken amiss, advises Dr Sanjay Saxena, plant tissue expert, Tata Energy Research Institute (TERI). He feels that GEAC must make sure that all parameters have been met and sufficient data has been generated to prove that the crop is safe on all factors before it is released. â€œOnly after the GEAC is fully satisfied with all the data collected can any crop whether it GM mustard or any other be launched on a commercial scale,â€? he emphasizes. The transgenic mustard has also shown a 20 per cent increase in seed yield and oil content compared with the best check variety of mustard and the most popular Indian variety, Varuna. The growing period of GM hybrids was only four days more compared to Varuna, he said. Clarifying the gene pollution factor, Dr Verma said, â€œ Proagro's technology is tightly controlled and the genes cannot be found in any plant tissue except in the flowers, that too during a specific phase. The Bargene (the herbicide-resistant marker gene) can be found only in the green tissue (the leaves) and not in the seeds, thereby ensuring no gene pollution.â€? This technology is based on the same technology used for GM canola being used the US and Canada since 1997, he added. Proagro has its fingers crossed. Monsanto had to face a lot of bad publicity and stiff resistance when Bt Cotton was approved by GAEC for commercialization. Proagro is hoping that it will not have to face the similar flak if GM mustard is approved. Vidya Deshpande ]]> <![CDATA[Opportunities unfurling]]> https://biospectrumindia.com/news/95/1288/opportunities-unfurling.html https://biospectrumindia.com/news/95/1288/opportunities-unfurling.html Mon, 10 Feb 2003 17:17:00 +0530 On 1 January 1995 India became a signatory to World Trade Organisation (WTO). India agreed to implement a product patent regime with effect from 1 January 2005. Since then, Indian pharma sector has gone through several remarkable changes in attitude and policies to prepare for the new patent regime. Some of these have been brought about through legislative action in the Union budgets in 2000 and 2001. The pharma industry was one of the major beneficiaries of budgetary allocations. The Government of India recognized it as a knowledge based industry. The industry, which is witnessing the transition phase in preparation for the new WTO-induced regime, and currently demonstrates wide-ranging capabilities in the field of drug manufacture and technology.  Biopharma in India  Biopharmaceuticals contribute about 80 percent of the overall Indian biotech pie. This is comparable to the global scenario. A holistic view will bare the fact that a lot of back-end work in R&D is being pursued in India particularly in the academic institutions. Pioneers in the field like Shantha Biotechnics, which launched the country's first indigenous recombinant product, Hepatitis B vaccine in 1997, are focused more on applied basic research with the objective of commercializing products which are affordable to the masses. Companies like Aventis, Dr Reddy's Lab, Nicholas Piramal, Smithkline Beecham, Bharat Biotech, Biocon India, and Wockhardt are the other key players in the biopharma sector. We find a strong base of biopharma in Ahmedabad, Mumbai, Bangalore, Hyderabad, and Pune. "The biopharma industry in India is still in its infancy. An overview of the market indicates a turnover of Rs 500 crore. However, over, 80 percent of this is hogged by imported products. This is the dichotomy. The concerned authorities on the one hand express their desire to encourage indigenous products but on the other hand also allow duty-free imports. There should be a level playing field. In several product categories, the installed capacities of indigenous manufacturers outstrip domestic demand, so where is the need to import? Moreover, Indian pharma companies have proved beyond doubt that the quality of their products match international standards," says Varaprasad Reddy, managing director, Shantha Biotechnics Pvt Ltd.   The opportunity India is in a unique position in terms of genetic resources. It has several ethnic populations that are valuable in providing information about disease predisposition and susceptibility, which in turn, will help drug discovery. In the drug discovery process, pharmaceutical or biotech companies need tremendous software support to write algorithms, develop software for existing algorithms, manage databases and for other key activities. The IT and pharmaceutical industries should team up with researchers to harness India's natural competitive advantage and strength in this sector. The main investment opportunities in the pharma industry are in diagnostics, vaccines and recombinant therapeutic proteins. Diagnostics:  According to Confederation of Indian Industry (CII), the market for diagnostics in India was at about $200 million, by the end of 2002. It says that around 50 percent of the demand is met by imports. There is an increased consumption of diagnostic devices and tests in public hospitals. There are more than 11,500 hospitals and 14,000 diagnostic laboratories in India that consume large volumes of diagnostics. Vaccines:  The Indian local vaccine market is currently in the region of $100 million and this is growing at the rate of more than 20 percent per year. The potential for these products is immense with the possible market for all types of diarrheal vaccines alone being about $200 million. Vaccine  Estimated requirement  (million doses) DPT 114 DT 57 Tetanus toxoid 200 BCG 43 Oral polio 225 Measles 46 Measles, Mumps & Rubella (MMR) 7.50 Rabies - Sheep brain based - Cell culture based 1.50 5 Hepatitis B - Plasma derived - Recombinant 0.20 45 Typhoid (attenuated oral & injectable) 50 H. influenza type B 5 Meningitis 2   Source -CII Major multinational pharmaceutical companies active in the vaccine businesses in India include SmithKline Beecham, Hoechst, Glaxo Wellcome and the Serum Institute. In addition, Shantha Biotechnics manufactures a recombinant HBsAg vaccine (Shanvac B), at a cost of approximately $5 per dose. This is the first such genetically engineered product from any category in India.   Although vaccines against tetanus (T), diphtheria (D), pertussis (P) and their combinations (like DPT and DT), BCG and measles are produced in the country. Genetically engineered as well as human plasma derived from hepatitis B vaccines is still being imported. Human diploid cell culture based vaccines against measles, mumps and rubella (MMR) are being locally produced. Several other vaccines like attenuated oral as well as Vi antigen based injectable typhoid vaccine are also required in the country in large quantities. Recombinant Therapeutic Proteins:  The Indian government has granted marketing licences for about 25 recombinant protein therapeutics. These include insulin, alpha interferon, hepatitis B surface antigen based vaccine, GM-CSF, G-CSF, blood clotting factor VIII, erythroproietin, streptokinase, human growth hormone and follicle stimulating factor. Of these, only hepatitis B surface antigen-based vaccine is produced in the country and all other products are imported. Recombinant insulin, human growth hormone, in terferon and hepatitis B vaccines enjoy larger market share. Medical proteins such as relaxin, rennin, the interleukins and tumor necrosis factor also offer market opportunities. Several companies, including Wockhardt, Piramal and Dabur are exploring the opportunities to manufacture bio-generics. In addition, Dabur India is developing plant medicines and is working on a natural substance-based immuno-modulator. According to DA Prasanna, vice chairman, Wipro Ltd and executive officer, Wipro Health Sciences, "India should concentrate on two niche areas - drug discovery design system and  clinical trials - in biotechnology both  domestically and internationally. Locally, the country has to stress more on the drug discovery design system. And internationally, India has to look at clinical trials."  "We will find ample opportunities in Indian biopharma sector particularly in drug discovery and clinical trails. It is expected to capture about 60 percent of the IT spending of Rs 600 core in the coming years. Major pharma companies like Dr. Reddy's  Laboratories, Ranbaxy and Shantha Biotechnics Pvt Ltd have already commenced activities in clinical trials," adds S Sabyasachi, manager, demand side research, IDC India. The Government initiatives  In India, medical biotechnology has gained more importance with spectacular advances in biology. This is mainly due to a number of emerging and re-emerging infections requiring immediate attention for development of suitable diagnostics and therapeutics. Now biopharma has become an important component of the national economy.  With the changing scenario, the government has announced a new Indian Pharmaceutical Policy 2002. It focuses on liberalization reducing number of drugs subject to price control and opening the market to foreign investment. The policy also stresses on setting up of a Pharmaceutical Research and Development Support Fund to boost R&D. In addition to these efforts, several international biotech events are organised with the rise of the genomics era, stem cell research and bioinformatics. These have percolated down the national biotechnology scene with a large number of scientists galvanized to reap the benefits. The Department of  Biotechnology (DBT) is making allefforts for the development of suitable diagnostics, vaccines, therapeutics and better drug delivery systems. The approach of multi-institutional projects and networking have paid rich dividends in terms of utilizing national expertise towards achieving welldefined aims.  The DBT has set up a Task Force under the chairmanship of Prof. H Sharat Chandra, director, center for human genetics, Jawaharla Nehru Center for Advanced Scientific Research, Bangalore to monitor the projects. The Task Force has been evaluating the projects. It is also meeting regularly in generating new projects for genomics, stem cell, biology, tuberculosis, HIV, cholera etc.  Further DBT has been supporting the projects taken up by the premier research centers in a contract mode for the last decade. As a result, various labs in the country have developed a number of prototype test systems. Some of these prototypes have already been transferred to industries for fine-tuning, upscaling and commercialization.  Technologies transferred and launched in the market Technology Developed by Launched by Leprosy immunodulator NII, New Delhi Cadila Pharma, Ahmedabad Leshmaniasis detention kit Western Blot for HIV- I &II CDRI, Lucknow CRI, Mumbai Span Diagnostics Ltd J Mitra &Co, New Delhi Naked Eye agglutination system for HIV- I&II University of Delhi , South Campus Cadila Pharma, Ahmedabad Hepatitis C Diagnostics ELISA based ICGEB, New Delhi Xcytron, Bangalore. Tribulations before the sector In biopharma sector, human resources are very critical. The educational institutions lack sophisticated instrumentation. A well-defined regulatory framework must be in place, preferably a single body for approvals on the lines of Center for Business and Economic Research (USA). Another problem is the Intellectual Property Rights (IPR) issue. It must be addressed, as the experts in this sector are few. More than 15 percent of the scientists in the US Pharma industry are of Indian origin. They must be motivated to return-reverse brain drain. The skill sets of those emerging from colleges must be improved in terms of practical knowledge. As stated earlier the infrastructure needs to be strengthened and a well-defined regulatory framework must be in place. Practical skills need to be improved. The curriculum also should be upgraded to meet global standards. An expert committee must be set up for addressing these issues urgently. Strategic alliances between academic institutions and the industry and biotech-pharma must be encouraged. These will largely contribute towards making India a powerhouse in biopharmaceuticals.  Besides, the sector is facing other problems like lack of product patents and restrictive foreign exchange regulations, which led to poor MNC exposure in the country. Small scale industry exemptions led to proliferation of small formulation manufacturers and low cost manufacturers and price ceiling under Drug Price Control Order limited profit margins and shifted the focus onto cost control.  Reddy maintains, " There is a saying that India has been reduced to a dumping ground for overseas pharma companies. Recently it was brought to our notice that a leading MNC is indulging in unfair/unethical practices to promote one of its products, which could prove detrimental to the efforts of indigenous manufacturers. This is largely due to a loose regulatory framework which neither has the will nor the wherewithal to stop such practices." Indian pharmaceutical market scenario The Indian Pharmaceutical sector is highly fragmented with over 20,053 registered pharmaceutical manufacturers in the country. The leading 250 pharmaceutical companies control 70 percent of the market (FY 2000). The top 10 companies cover around 31percent of the pharma market. During FY 2000, production of formulations was around Rs 184 billion and of bulk drugs Rs 45 billion. India's pharmaceutical imports (including bulk drugs, formulations, intermediates, chemicals, solvents etc) are in the region of Rs 30 billion (Rs 22.65 billion bulk drugs and Rs 7.15 billion formulations), while exports are around Rs 87.30 billion. The industry provides direct employment to 460,000 people. The value of the pharma market in India was $3.8 billion in 2000. Indian pharmaceuticals account for 1percent of global sales in terms of value and 8percent in terms of volume. Globally it ranks fourth in volume terms and thirteenth in value. Pharmaceutical industry domestic sales were around Rs170 billion in 2001. Of this, formulations account for 81.5percent with the remaining 18.5percent in bulk drugs. (Ref: Organisation of Pharmaceutical Producers of India (OPPI) Pharmaceutical Compendium 2001). Fast forward With intense demand for low-cost R&D to fuel innovation, India's developing skills and infrastructure in the R&D phases of drug development are providing an enticing proposition for both the global pharmaceutical companies and investors. India's skills in technical computing, bioinformatics and cheminformatics, data integration have the ability to resolve issues surrounding. The Singapore-based International Data Corporation (IDC), Asia/Pacific, believes that India will become an ideal center for outsourcing R&D and drug development processes, which will surely entice new businesses to develop and attract much private investor attention. "Once India develops a genuine global reputation in life sciences innovation, it will be attracting investor attention in its own Intellectual Property", the IDC report says.  Even the Union Health Minister Shatrughan Sinha's announcement on the increase in budget allocation for health research will definitely boost the sector in the coming years.  "Biopharma is going to be a highest growing area. Today therapeutic protein and monoclonal antibodies are becoming the most powerful pharmaceutical agents for some of our deadliest of diseases. Whether it is any genetically linked disease or cancer, these are the molecules that are able to do something about it," says Kiran Mazumdar Shaw, chairperson and managing director, Biocon India Group. 1960's Milestones in pharma industry Government of India laid the foundation for the domestic pharma industry by promoting Hindustan Antibiotics Ltd and Indian Drugs and Pharmaceuticals Ltd for the manufacture of bulk drugs. 1970 Government introduces Indian Patent Act (IPA) and Drugs Price Control Order (DPCO) 1994 Syngene International, country's first Contract Research Center (promoted by Biocon India Group) to offer R &D services in drug discovery based on modern biology. 1997 Shantha Biotechnics launches India's first recombinant product, Hepatitis B vaccine Government sets up an independent body of experts called National Pharmaceutical Pricing Authority 2000 Genomed, country's first joint venture between institute (CBT) and Industry (Nicholas Piramal) to pursue pharmaco â€“genomics 2001 Genetic Engineering Approval Committee (GEAC) approves Wockhardt's EPO Drug authority implements GCP guidelines for clinical trials 2002 Government introduces Indian Pharmaceutical Policy 2002, based on the recommendations made by the Pharmaceutical Research and Development Committee "Indian biopharma is still in an immature stage as far as data driven drug discovery and development are concerned. About 80 percent of action in biopharma, at present, is taking place from the US. Hence Strand Genomics, the first Bioinformatics company in India has been offering services to the US companies to improve efficiencies of drug discovery and development. These are not valuable at this stage to Indian biopharma," says Prof. Vijay Chandru, chairman, Strand Genomics.  " India has a strong pharma base as well as the necessary skills in this field. Thus the market for biopharma products will see an exponential growth. This when coupled with our strength in IT will provide cost-effective solutions to drug discovery efforts. However the infrastructure needs to be strengthened and the cost of inputs like power, need to reduce. A strong regulatory framework should be in place. In future, the world may witness India being a hub for drug discovery efforts," adds Reddy. Abraham Thomas, managing director, IBM India Ltd, believes, "The Indian Pharmaceutical market shows positive signs. The Indian Government through DBT has been promoting the growth in this industry. The DBT and the Indian Council of Agricultural Research (ICAR) have stressed the importance of R&D for biotechnology. The Indian life sciences market has the potential, which we would be looking at tapping, in keeping with IBM's global focus on Life Sciences. " Narayan Kulkarni ]]> <![CDATA[A new ray of hope]]> https://biospectrumindia.com/news/95/1758/a-new-ray-of-hope.html https://biospectrumindia.com/news/95/1758/a-new-ray-of-hope.html Mon, 10 Feb 2003 16:52:00 +0530 The human genome project signals a paradigm shift for the global pharmaceutical industry in its search for critical drug discoveries. The drug discovery process will be transformed dramatically in the post genome-sequencing era and will occupy center of attention in the modern biological research. This will have far reaching implications in the area of health care and molecular medicine in coming century. Earlier, the drug discovery research has been traditionally driven by chemistry. In effect, it has been a case of compounds--painstakingly synthesized one at a time--looking for biological targets. But all that's changing. Today, drug research is driven by biology - molecular genetics, genomics, and bioinformatics.  The area of drug development through genomic research promises development of new diagnostic procedures and therapeutic products that will enable the doctors to prescribe the required drugs selectively to the patients for whom they will be effective and safe. Genomics might bring back the concept of customized medicine, as practiced in ayurveda. To take advantage of the opportunities opened by genomics, several well-established Indian pharmaceutical companies such as Nicholas Piramal India Ltd, Ranbaxy, and Dr Reddy's Lab., are in this fast growing sector. In addition to pharmaceutical companies, genomics is providing a great scope for another fast growing field such as bioinformatics. The global bioinformatics industry clocked an estimated turnover of $2 billion last year and this figure is expected to grow to $60 billion in the next three years.  Rapid progress in genomic research and its potential applications have opened up new vistas for the twenty first century. The post genome era promises to identify genes responsible for both single disorders and complex multi-factorial diseases at a much faster rate than ever. Further technology and resources generated by the human genome project and other genomics research are already having a major impact on research across life sciences.  Programs   Looking at the potentiality of genomics, the government of India has launched a program called Human Genetics and Genome Analysis. The main objectives of this program are to identify, map and characterize genes related to genetic disorders prevalent in India for diagnosis, prevention, and management of genetic disorders and to develop new methods for the analysis and interpretations of genomic DNA sequences.  The department of biotechnology (DBT) has established 16 genetic diagnosis cum counseling units. These units are providing patient service since 1990-91, in reducing genetic disorder in the country. So far about 16,500 affected families were benefited from these units. The genetic clinics have been established for molecular diagnosis and counseling for common genetic disorders prevalent in the country. These centers are developing new diagnostic kits and also using the exiting diagnostic kits for molecular diagnosis of the genetic disorders. Also they provide diagnosis and counseling services to the affected people. The diseases diagnosed in these centers include thalessemia, haemophilia, Down's and Turner's syndrome, and others.  Prospects  The Indian geneticists say that the country could become a world leader in â€œfunctional biological genomicsâ€? with the country's diverse ethnic race gene pool, provided that the scientist take up the issue seriously and work systematically. However the only real challenge before the scientists is to set up an inter-disciplinary research program under which molecular biologists, geneticists, clinicians, computer scientists and even theoretical physicists and synthetic chemists would work together.  Since there exists a gap between the development of interconnectivity of computers through internet and framing of cyber laws, the scientists urge that the geneticists along with legal experts and politicians should make sure that the information generated is not misused. Hence it is high time for the Indian science managers to work on ethical and legal issues involved simultaneously. Narayan Kulkarni ]]> <![CDATA[...And now its BioinformaticsÂ ]]> https://biospectrumindia.com/news/95/7077/and-now-its-bioinformatics-.html https://biospectrumindia.com/news/95/7077/and-now-its-bioinformatics-.html Mon, 10 Feb 2003 14:40:00 +0530 After 11 September and the economic slow down, the Indian information technology companies, which had a good share in the software services market, are looking for alternate revenue streams. One of the alternatives is bioinformatics. Probably, it represents the biggest opportunity for the IT industry since Y2K. Experts in this field observe that if industry and government work together, it is possible for Indian industry to garner five percent share of the global bioinformatics market. Bioinformatics is the field of science in which biology, computer science, and IT merges into a single discipline. The ultimate goal is to enable the discovery of new biological insights and to create a global perspective from which unifying principles in biology can be distinguished. Bioinformatics has three important sub-disciplines, such as: the development of new algorithms and statistics with which assess relationships among members of large data sets the analysis and interpretation of various types of data including nucleotide and amino acid sequences, protein domains and protein structures the development and implementation of tools that enable efficient access and management of different types of information. Concept of database Bioinformatics today, by general consent, is actually a much latter development from the concept of the database. The concept of computer database came into practice in1948, through the US defense initiatives. Database is meant to store voluminous information in an orderly fashion. It facilitates addition and deletion of information and provides for its retrieval in any one or more of the several different permutations and combinations as desired by the user. Biologists have taken the advantage of this facility from the very early stages and have used it in different contexts. The general belief about bioinformatics is that it constitutes only genomics and proteomics. Genomics is the study of total molecular sequencing of one set fall genes of an organism and proteomics is about amino acid sequences and the three-dimensional structure related to the function of proteins. It is concerned with compounds of high molecular weight (HMW), particularly the nucleic acids and proteins. But in recent times cheminformatics (study of low molecular weight (LMW) compounds), glycomics (study of carbohydrates), metabolics (study of metabolic pathways in organism) and drug design through bioinformatics are also being projected as legitimate areas of bioinformatics. Bioinformatics in India Studies of IDC points out that India will be a potential star in bioscience field in the coming years after considering the factors like bio-diversity, human resources, infrastructure facilities and government's initiatives. According to IDC, bioscience includes pharma, Bio-IT (bioinformatics), agriculture and R&D. IDC has been reported that the pharmaceutical firms and research institutes in India are looking forward for cost-effective and high-quality research, development, and manufacturing of drugs with more speed. Bioinformatics has emerged out of the inputs from several different areas such as biology, biochemistry, biophysics, molecular biology, biostatics, and computer science. Specially designed algorithms and organized databases is the core of all informatics operations. The requirements for such an activity make heavy and high level demands on both the hardware and software capabilities. This sector is the quickest growing field in the country. The vertical growth is because of the linkages between IT and biotechnology, spurred by the human genome project. The promising start-ups are already there in Bangalore, Hyderabad, Pune, Chennai, and Delhi. There are over 200 companies functioning in these places. IT majors such as Intel, IBM, Wipro are getting into this segment spurred by the promises in technological developments. "Negative growth of pharma drug pipelines and increase in R&D funding have played crucial role in the growth of bioinformatics sector in the country. At the same time there has been a meltdown of bioinformatics companies in the US. This consolidation will continue and only the companies with a clear focus and understanding of pharma-biotech sector will survive," says Dr S Seshadri, CEO, Strand Genomics, the first Bioinformatics company in India. "Negative growth of pharma drug pipelines and increase in R& D funding have played crucial role in the growth of bioinformatics sector in the country. At the same time there has been a meltdown of bioinformatics companies in the US. This consolidation will continue and only the companies with a clear focus and understanding of pharma-biotech sector will survive," says Dr S Seshadri, CEO,Strand Genomics Commenting on the scope for bioinformatics sector in the country, Aruradha Acharya, CEO, Ocimum Biosolutions, Hyderabad, says, "bioinformatics is crucial for the advancement of the biotech industry because it can help tremendously to cut the time frame usually required to develop a product. It also helps in bringing about standardization and discipline in the field by automating some tasks and introducing checks in the process. Since it has become standard practice in most countries, those who don't follow it will find it difficult to keep pace with development in this area. " Government initiatives Informatics is a very essential component in the biotech revolution. Ranging from reference to type-culture collections or comparing gene sequences access to comprehensive up-to-date biological information, all are crucial in almost every aspects of biotechnology. India, as a hub of scientific and academic research, was one of the first countries in the world to establish a nation wide bioinformatics network. The department of biotechnology (DBT) initiated the program on bioinformatics way back in 1986-87. The Biotechnology Information System Network (BTIS), a division of DBT, has covered the entire country by connecting to the 57 key research centers. BTIS is providing an easy access to huge database to the scientists. Six national facilities on interactive graphics are dedicated to molecular modeling and other related areas. More than 100 databases on biotechnology have been developed. Two major databases namely coconut biotechnology databases and complete genome of white spota syndrome of shrimp has been released for public use. Several major international data bases for application to genomics and proteomics have been established in the form of mirror sites under the National Jai Vigyan Mission. The BTIS proposes to increase the bandwidth of existing network and provide high-speed internet connectivity to continue with its present activities of training, education mirroring of public utility packages, consideration of R&D projects and support to different research activities in this field. The DBT is planning to set up a National Bioinformatics Institute as an apex body for the bioinformatics network in the country. The DBT also proposes to bolster a proper education in bioinformatics through publication of textbooks and monographs by reputed scientists in the field. Collaboration with the industry is also poised to increase in the coming years. Opportunities According to Confederation of Indian Industry(CII), the global bioinformatics industry clocked an estimated turnover of $2 billion in 2000 and is expected to become $60 billion by 2005. If the industry and government work together it is possible to achieve a five percent global market share by 2005, i.e., a $3 billion opportunity in India. The past two years has seen many large multinational pharmaceutical companies acquiring other small companies and developing in the biosciences sector. IDC currently forecasts a compound annual growth rate (from 2001-02 to 2004-05) of about 10 percent in the spending on Information Technology by bioscience organizations. Considering the local market is generally less mature than those in the US and Europe, IDC forecasts more aggressive growth beyond 2005, as many of the organizations attempt to play "catch-up". Enterprise applications including data warehousing, knowledge management, and storage are being pursued by these companies as priorities. IDC expects IT spending in biosciences in India will cross $138 million by 2005, mainly in the areas of system clusters, storage, application software, and services. Also the governments life science focus provides a great deal of the necessary backbone to develop and deliver innovative products and technologies. This focus will also helps to build fast-growing and lucrative enterprises, attract international investment, and create additional high-value employment opportunities. Hence the focus of the IT sector should be on products and services that aligns with bioscience needs. Demonstrating a true understanding of the IT requirements of biotechnology processes is the key for IT suppliers to bridge the chasm that currently exists between IT and Science. Advantages India has India is well placed to take the global leadership in genome analysis, as is in a unique position in terms of genetic resources. India has several ethnic populations that are valuable in providing information about disease predisposition and susceptibility, which in turn will help in drug discovery. However, as India lacks the records of clinical information about the patients, sequence date without clinical information will have little meaning. And hence partnership with clinicians is essential. The real money is in discovering new drugs for ourselves and not in supplying genetic information and data to the foreign companies, who would then use this information to discover new molecules. The genomic data provides information about the sequence, but it doesn't give information about the function. It is still not possible to predict the actual 3-D structure of proteins. This is a key area of work as tools to predict correct folding patterns of proteins will help drug design research substantially. India has the potential to lead if it invests in this area. Looking at this biotech and pharma companies need tremendous software support. Software expertise is required to write algorithms, develop software for existing algorithms, manage databases, and in final process of drug discovery. Some major opportunity areas for IT companies include: Improving content and utility of databases Developing better tools for data generation, capture, and annotation Developing and improving tools and databases for comprehensive functional studies Developing and improving tools for representing and analyzing sequence similarity and variation Creating mechanisms to support effective approaches for producing robust, software that can be widely shared. As major pharmaceutical and genome-based biotech companies invest heavily in software, Indian IT companies have a great business opportunity to offer complete database solutions to major pharmaceutical and genome-based biotech companies in the world. Pure cost benefits for the biotech companies will definitely drive the bioinformatics industry in the country. The biotech industry in 2000 has spent an estimated 36 percent on R & D. Success for many will mean a drastic reduction in R&D costs. Thus biotech companies will be forced to outsource software rather than developing propriety software like in the past. Since the cost of programs for handling this data is extremely high in the west, Indian IT companies have a great business opportunity to offer complete database solutions to major pharmaceutical and genome-based biotech companies in the world. The IT industry can also focus more on genomics through different levels of participation areas such as hardware, database product and packages, implementation and customization of software, and functionality enhancement of database. Abraham Thomas, managing director, IBM India Ltd, says, "the alignment of a vast pool of scientific talent, a world-class IT industry, a vigorous generic pharmaceutical sector and government initiatives in establishment of public sector infrastructure and research labs are positioning India to emerge as a significant participant on the global biotech map." With an objective to help and rise bioinformatics sector to the world map the Bioinformatics Society of India (Inbios) has been working since August 2001. The Inbios already has over 270 members in a short span of one and half years. It has become a common informal platform for the younger generation to learn and contribute to this sun rising field in India. Kiran Mazumdar Shaw, chairperson and managing director, Biocon India Group says, "bioinformatics is a tool. People should not confuse bio-informatics as ending in it. It is a very important tool, just like how software is a tool. It is service business. Use bio informatics to mine a lot of knowledge. Create types of new hypothesis and to have a very interesting interpretation of databases of genomics and proteomics. Bioinformatics has a great potential in the service industry." On the other side, Anuradha Acharya, CEO, Ocimum Biosolutions, says," bioinformatics is crucial for the advancement of the biotech industry since it can help to tremendously cut the time frame that is usually required to develop a product. It also helps in bringing about standardization and discipline in the field, by automating some tasks and introducing checks in the process. Since it has become standard practice in most countries, those that don't follow it will find it difficult to keep pace with developments in this area. " Problems in the sector The major issue for India is its transition from a recognized global leader in software development to areas of real strength upon which it can capitalize in the biosciences. The identifiable areas are in computation biology and bioinformatics, where a substantial level of development skills are required to develop custom applications to knot together and integrate disparate databases (usually from several global locations), simulations, molecular images, docking programs etc. The industry people, meanwhile, say that the mushrooming of bioinformatic institutes is creating a problem of finding talented and trained individuals in this industry. While many of them has a superficial knowledge and a certificate, India lacks true professionals in this area. Most people, who opt for bioinformatics are from the life sciences areas that do not have exposure to the IT side of bioinformatics, which is very important. Another issue is that some companies face shortage of funds and infrastructure. The turn around time for an average biotech industry to breakeven would be around three to five years. "Bioinformatics has a good future, but this is not a field for the masses. People who get involved should have a strong motivation and desire to remain in this field to see true results. The field is justifiable if a company is expecting revenues up to a few million dollars only," says Anuradha Acharya, CEO, Ocimum Biosolutions Most of the venture capitals and other sources of funding would not be very supportive, especially if the company is not part of a larger group venture. It would help if the government would take an active role in building infrastructure and funding small and medium entrepreneurs. To over come the difficulties, Acharya says, "this sector should get some support from the government. Many other countries have solid programs in genome research sponsored by the government. India being a country with such great biodiversity, we are able to do great research. However the investment is more and a result requires more time so it is necessary for the government to be involved. " She further adds, "the government should also be involved in the education part of it. While a lot of programs have started in the last few years, not all of them have the same standard. There should be a dedicated effort to standardize education in bioinformatics across the country. This can only be done by consulting the companies who are on the cutting edge of bioinformatics." Looking at the pace of growth, lots of institutes have mushroomed in different parts of the country. Kiran Mazumdar Shaw, chairperson and managing director, Biocon India Group, the country's first and leading biotech company in India expressed her concern and said that appropriate steps should be initiated at the earliest. "As the chairperson of CII National Committee on Biotechnology, I have discussed the issue with the concerned officials in government departments. We are waiting for the government's move on our recommendations," says Shaw. Looking ahead The hype about the sector has made a lot of difference. This has caused a sudden surge in the number of companies. This is normal for any new technology which promises potential, especially as the perceived conception that it was relatively easy to get in with a certain amount of IT expertise. It is better to adopt, wait and watch policy to know who will remain in the market. Acharya says, "bioinformatics has a good future, but this is not a field for the masses. People who get involved should have a strong motivation and desire to remain in this field to see true results. This field is justifiable if a company is expecting revenues up to a few million dollars only. This would not make sense for a very large organization. As the company grows, it needs to step into other validation areaslike wet lab." Even DA Prasanna, executive officer, Wipro Healthcare and Lifescience, has the same opinion. He says, "with three Indian pharma majors already having a molecule each to their credit in the drug discovery process, big companies in IT industry will definitely look this as an attractive investment opportunity to leverage on maximum returns." Commenting on the scope of bioinformatics in near future,Dr Seshadri says, "Bioinformatics is an integral part of drug discovery and development. Most of the pharma-biotech R&D is moving in silico-creating scope for bioinformatics sector. India has a vast pool of talented human resources in computer science and life sciences. Institutes like IIT's, IISc., NCBS etc., produce world-class engineers and life science scientists. Funding is not an issue for companies creating IPR and this is validated by closure of first round funding of Strand." ]]> <![CDATA[Joining the mainstream]]> https://biospectrumindia.com/news/95/6835/joining-the-mainstream.html https://biospectrumindia.com/news/95/6835/joining-the-mainstream.html Fri, 07 Feb 2003 17:47:00 +0530 Something extraordinary happened in biotechnology in 2002. At least in India. The government approved the use of genetically modified crop Bt cotton in March 2002. This was a major step in the biotechnological march of the nation as the decision had been hanging fire for many years. With that small step India joined a select club of nations using one of the fruits of modern biotechnology. And that was not the only major thing that happened in 2002 in biotechnology. After the successful publication of the entire human genome, biotechnology has been a center of attention worldwide. The claims about the birth of Baby Eve, claimed to be the first cloned human being in December 2002 have only reinforced global attention on biotechnology. Genetic engineering is indeed the popular face of biotechnology. More importantly, biotechnology joined the mainstream in 2002. It is no longer a specialized segment of science confined to high tech laboratories. Some of the nation's leaders have started talking about biotechnology in the same breath they talk about our information technology prowess. Prime Minister AB Vajpayee talked about biotechnology while releasing the Science Policy in early January at the Indian Science Congress session in Bangalore. Finance Minister Jaswant Singh has stated that biotechnology is one of the key areas which require massive investments to fuel the country's economy on accelerated growth path. Several state chief ministers too have started mentioning biotechnology as a sector to attract investments. Remember, this is how IT became a rage in the country. From the sanitized rooms of research institutions and companies, IT became the new growth mantra when the nation's top leaders turned their attention to it. And many leaders have not still stopped talking in glowing words about our IT superpower status. Can biotechnology attain the same status as IT? Yes, it can. Globally too, biotechnology is slowly entering the hallowed portals of the 'knowledge economy.' Biotechnology companies, especially in the areas of pharma, agriculture, bioinformatics and genomics are grabbing public attention. In India too, the same trend is seen. Companies like Biocon, Shantha Biotecnics, Strand Genomics, Monsanto, Proagro, Ranbaxy, Dr Reddy's etc., are vying for public attention for their pioneering works. And many of them feel that they could become the equivalent of Infosys in IT in the coming years. There is unanimity among the key players of biotechnology that it is time nation put its weight behind the sector. What better way to do this than formulating a National Biotechnology Policy which articulates the national vision on this promising sector. They all feel that such a policy will put the stamp of national authority and help the sector grow to take its rightful place in the world. The cover story of the inaugural issue of the new look BioSpectrum takes a look at this topic in detail. There are other columns too where some of India's top minds in biotechnology share their vision and concerns. With your support and attention, I hope BioSpectrum will become the natural forum for exchange of all views and informed debate about the needs and deeds of the biotech industry for decades to come. N Suresh ]]> <![CDATA[D A Prasanna is ACRO India's new Chairman]]> https://biospectrumindia.com/news/95/1067/d-a-prasanna-is-acro-indias-new-chairman.html https://biospectrumindia.com/news/95/1067/d-a-prasanna-is-acro-indias-new-chairman.html Tue, 30 Nov -001 00:00:00 +0553 On January 10 2014, members of Association of Contract Research Organizations (ACRO INDIA) met and Mr D A Prasanna was elected unanimously as the Chairman of the Association. He took over from the previous Chairman Mr Apurva Shah, Group Managing Director, Veeda Clinical Research. Speaking on the appointment, Mr Prasanna said, clinical research in India has contributed to bringing vaccines, drugs, devices to needy patients at affordable prices. From neglected diseases like Kala Azar to tropical disease like Malaria, Indian clinical research has alleviated suffering. India has made a name in the world in lowering health care costs through generics and building a reputation in development of biotech drugs and medical devices. In the last few years, clinical research has come under criticism as being unsafe and severe regulation has been imposed. ACRO India's priority is to promote safe conduct of clinical research without impeding the development of much needed drugs for Indian patients. ACRO India will promote global best practice to make Indian research data useful to market drugs developed in India, across the world. As the Founder Chairman of Ecron Acunova CRO, Mr Prasanna has built an Indian CRO with presence in 28 countries and helped bring advanced cell therapy drugs to generic drugs to Indian and global patients. He has experience in leveraging Asian competitiveness building successful global business in medical technology for GE and software for Wipro. Considered a thought leader in Life Sciences, he has held global CEO positions in GE Healthcare and was Vice Chairman of Wipro. He serves on biotechnology vision group of Karnataka government.ACRO India founded and registered in India in 2005 has been formed under the aegis of Confederation of Indian Industry (CII) for bringing all CRO's operating in India on one common platform. ACRO India will be used to promote quality research, uphold ethics, share best practices, promote synergies amongst members, to deliberate and act upon common concerns, specially with regard to Indian regulations and industry environment. ACRO India will represent the interests of Indian CROs to regional, national and international authorities and organizations. ]]> <![CDATA[Piramal Enterprises acquires the brand CALADRYLÂ® in India]]> https://biospectrumindia.com/news/95/1202/piramal-enterprises-acquires-the-brand-caladryl-in-india.html https://biospectrumindia.com/news/95/1202/piramal-enterprises-acquires-the-brand-caladryl-in-india.html Tue, 30 Nov -001 00:00:00 +0553 Piramal Enterprises Limited (Formerly Known as Piramal Healthcare Limited) today announced that it has acquired the over-the-counter (OTC) brand CALADRYL in India from Valeant Pharmaceuticals International, Inc. The and CALADRYL in India was owned by Valeant Pharmaaceuticals International, Inc ("Valeant"). The rights to this brand were acquired by Valeant from Johnson and Johnson in the year 2012. CALADRYL is an anti-pruritic solution know for dermatosis and itching. This acquisition enables Piramal Enterprises ("PEL") to widen its cpnsumer products portfolio in the skin care segment. PEL's current consumer products portfolio includes brands such as Lacto Calamine, Saridon, i-pill, Itchmosol and Supractiv Complete, along with niche market brands likePill, i-can, Jungle Magic, Tetmosol and Triactiv. The division has one of India's largest filed forces in the industry covering more than 100,000 towns. ]]> <![CDATA[Raise tobacco taxes to reduce consumption: Public Health Foundation of India]]> https://biospectrumindia.com/news/95/1365/raise-tobacco-taxes-to-reduce-consumption-public-health-foundation-of-india.html https://biospectrumindia.com/news/95/1365/raise-tobacco-taxes-to-reduce-consumption-public-health-foundation-of-india.html Tue, 30 Nov -001 00:00:00 +0553 Public Health Foundation of India (PHFI) in its study has underlined that a 10 percent increase in cigarette prices will lead to almost three percent decrease in consumption and seven percent increase in government revenues. Union Health Secretary Luv Verma released the findings of PHFI study on "An Empirical Study of India's Fiscal Policies against Tobacco: A State Level Analysis."The study highlighted that a 10 percent increase in bidi prices will lead to almost five percent decrease in consumption and four percent increase in government revenues.Further, it found that cigarette excise can be increased by 370 percent of present level, leading to a 54 percent decline in consumption and 115 percent increase in revenue while bidi excise can be increased by 100 percent of present level, leading to a 40 percent decline in consumption and 22 percent increase in revenue. The study also found that in India, so far, taxes have not been used effectively to reduce tobacco consumption."The current tax rates of tobacco products are not only low but the tax structure of tobacco products are complex and tax governance poor. As a result, tobacco taxes and prices have not deterred tobacco consumption."Bidi, which is largely consumed by people, is least taxed. Significant potential exists in India to hike taxes rates in India to reduce tobacco consumption and mop up revenue to the government which is presently fiscally-challenged," said Dr Sakthivel Selvaraj, senior public health specialist, economics and financing, PHFI. "According to the Global Burden of Disease Study 2010, tobacco use is the second largest risk factor for death. The enormous burden of tobacco use in India is well documented with nearly one million Indians dying each year."With India adopting a national target of 30 percent relative reduction of tobacco use by 2025, it is paramount that India's response to mitigate the tobacco problem is strengthened," said Dr Monika Arora, director health promotion, PHFI. The study used data from the Global Adult Tobacco Survey (GATS) India, 2009-2010 to study tobacco consumption patterns. Household consumption expenditure data on tobacco were obtained from the National Sample Survey Organisation (NSSO) and Consumer Expenditure Surveys (CES) from 1999-2000 to 2011-2012. The WHO's theme for this year's 'World No Tobacco Day' is 'Raise Tobacco Taxes'. Union Health Minister Harsh Vardhan also advocated raising taxes on tobacco products during an event organised by PHFI in collaboration with Ministry of Health and Family Welfare and WHO to commemorate 'World No Tobacco Day 2014' last week. ]]> <![CDATA[Sun Pharma announces USFDA approval for generic PrandinÂ® Company has 180-day marketing exclusivity]]> https://biospectrumindia.com/news/95/2000/sun-pharma-announces-usfda-approval-for-generic-prandin-company-has-180-day-marketing-exclusivity.html https://biospectrumindia.com/news/95/2000/sun-pharma-announces-usfda-approval-for-generic-prandin-company-has-180-day-marketing-exclusivity.html Tue, 30 Nov -001 00:00:00 +0553 Sun Pharmaceutical Industries recently announced that the US FDA has granted its subsidiary final approval for its Abbreviated New Drug Applications (ANDA) for generic version of Prandin®, Repaglinide tablets. Repaglinide tablets, 1 mg and 2 mg are therapeutic equivalents of Novo Nordisk's Prandin® tablets. These tablets have annual sales of approximately USD 200 million in the US. Repaglinide tablets are indicatedas an adjunct to diet and exercise to improve glycemic control in adults with type-2 diabetes mellitus. Sun Pharma's subsidiary, being the first-to-file an ANDA for generic Prandin® with a para IV certification, is eligible for a 180-day marketing exclusivity in the US. Established in 1983, listed since 1994 and headquartered in India, Sun Pharmaceutical Industries is an international, integrated, speciality pharmaceutical company. It manufactures and markets a large basket ofpharmaceutical formulations as branded generics as well as generics in India, US and several other markets across the world. In India, the company is a leader in niche therapy areas of psychiatry, neurology,cardiology, nephrology, gastroenterology, orthopedics and ophthalmology. The company has strong skills in product development, process chemistry, and manufacturing of complex API, as well as dosage forms. ]]> <![CDATA[Delhi to host biggest cancer congress]]> https://biospectrumindia.com/news/95/2985/delhi-to-host-biggest-cancer-congress.html https://biospectrumindia.com/news/95/2985/delhi-to-host-biggest-cancer-congress.html Tue, 30 Nov -001 00:00:00 +0553 The first Indian Cancer Congress (ICC) will be held from 21st to 24th November 2013 at the Kempinski Ambience Hotel in New Delhi. Experts from surgical, medical and radiation oncology will join forces with radiologists, pathologists, scientists, physicists, and ancillary service providers such as oncology nurses, technicians, and paramedics to comprehensively address various facets of cancer care. Additionally, patients, caregivers, advocacy groups, and NGO's will also have an opportunity to share the platform with policy makers. Hosted by the Association of Radio Oncologists of India (AROI), the Indian Association of Surgical Oncology (IASO), the Indian Society of Medical and Pediatric Oncology (ISMPO), the Indian Society of Oncology (ISO), and the Oncology Forum, the Congress enjoys the support of over 25 professional bodies, 100 cancer institutions, and 7 leading international associations involved in cancer care. With a confirmed faculty of over 250 global thought leaders, ICC has already received 3,000 delegates registration for the conference and 5,000 delegates are expected to attend. This international conference will act as a catalyst for further research, treatment and dissemination of knowledge in the field of cancer. Addressing the media today, Dr G K Rath, Chairman, Organizing Committee ICC 2013, stated, "We are excited to lay the foundation of one of the most empowering gatherings on cancer in India in the form of Indian Cancer Congress. Slated to be the biggest oncology event ever in India, the Congress will strive collectively to face the daunting challenge of cancer and showcase the lead India has taken in cancer research. It will establish India as an emerging leader in cancer care and will inspire both experts and the new generation to take on cancer with new learnings from their colleagues across the world." Over 300 leaders from across the country have worked together to create a very exciting scientific program. The Congress has received 1,740 abstracts from the scientific community across the world. The ICC will also offer 400 hours of deliberations during the 4 days of the event, with 10 pre-conference workshops planned in the sidelines. Oncotech, an exhibition of state of art technology, will display a range of equipment required for setting up a full-fledged cancer hospital. The conference will benefit not only cancer care providers, but also society as a whole. According to the ICC, there are 3,300,000 cancer patients in India. Each year, 600,000 of those patients die and doctors diagnose 1,000,000 new cancer cases. India bears a disproportionate amount of cancer cases and possesses 50% of the world's oral cancer cases. With this immense public need in mind, the final day of the conference speaks to the non-medical community, including volunteers, patients, families of victims, and the general public. This pioneering conference will promote and showcase all types of cancer research in India. Highlights of the program include breast oncology, surgical management of sarcomas, hematology, head and neck oncology, pediatric oncology, thoracic oncology, palliative care, preventive oncology, imaging and radiology, gastrointestinal and HPB cancers, pathology, genitourinary oncology, nuclear medicine, geriatric oncology, gynae oncology, and nursing oncology. Dr Harit K Chaturvedi, Organizing Secretary of the ICC, commented, "The scientific deliberations during the Congress and strengthening of collaborations between different arms of oncology are directed towards better patient care, better clinical outcome and most effected treatment. The treatment today is out of the reach of the significant section of our society. We hope this Congress will come out with well-defined strategies." Four days of programs as well as a day of pre-conference workshops on 20 November await the delegates. The programs will consist of a mixture of poster presentations, panel deliberations, round table discussions, and lectures, with an emphasis on discussions and audience participation. The ICC will help care providers implement new ideas and research into their practice as well as further the discussion of best practices to curtail the rapid growth of cancer cases and provide quality care to patients. ]]> <![CDATA[Vitamin D good for patients with Parkinson's disease]]> https://biospectrumindia.com/news/95/2993/vitamin-d-good-for-patients-with-parkinsons-disease.html https://biospectrumindia.com/news/95/2993/vitamin-d-good-for-patients-with-parkinsons-disease.html Tue, 30 Nov -001 00:00:00 +0553 A new study exploring vitamin D levels in patients with Parkinson's disease opens up the possibility of a new avenue of early intervention that may delay or prevent the onset of cognitive impairment and depression. 'Nearly 30 percent of people with PD suffer from cognitive impairment and dementia. Intervening in the development of dementia has the potential to improve morbidity and mortality in persons with PD,' said Amie L. Peterson of Oregon Health and Sciences University in the US.The role of Vitamin D is crucial here, said the study that appeared in the Journal of Parkinson's Disease. The researchers conducted an analysis of 286 patients with PD. They found that higher plasma vitamin D levels were associated with lower symptom severity, better cognition and less depression in the entire group. In this analysis, patients went through tests measuring global cognitive function, verbal memory, semantic verbal fluency, executive function and depression. Investigators found that for the entire group, higher levels of serum vitamin D3 were associated with greater fluency for naming vegetables and animals and immediate and delayed recall on a verbal learning test. 'The fact that the relationship between vitamin D concentration and cognitive performance seemed more robust in the non-demented group suggests that earlier intervention before dementia may be more effective,' said Peterson. A significant negative association was also found for vitamin D levels and depression for both the entire group and those who were not demented. Vitamin D's role in health has been a subject of considerable scrutiny in recent years. Low levels increase the risk of type 2 diabetes mellitus, multiple sclerosis, hypertension, cancer and infections. ]]> <![CDATA[Ranbaxy results]]> https://biospectrumindia.com/news/95/3105/ranbaxy-results.html https://biospectrumindia.com/news/95/3105/ranbaxy-results.html Tue, 30 Nov -001 00:00:00 +0553 Ranbaxy surpass 2012 guidance; Crosses Rs.120 Bn in Global sales Q4 CY 2012 Sales Rs.26,708 Mn CY 2012 Sales Rs.123 Bn, EBITDA Rs.18,227 Mn EBITDA margin 15%. Sales growth of 23% in Rupee termsRanbaxy Laboratories released their audited results for the Quarter and Year ended Dec 31, 2012. The key financial highlights include for Q4'12 include consolidated sales at Rs.26,708 Mn while the Q4'11 sales were at Rs.37,520. EBITDA stood at Rs.528 million while net profit was a loss of Rs.4,924 Mn. The profitability for Q4'12 was primarily impacted by the voluntary recall of Atorvastatin, which impacted the quarter by Rs.1,860 Mn and mark to market (MTM) loss of Rs.2,619 Mn on long term derivative contracts and foreign currency loans owing to a weaker rupee. The Consolidated sales for the year ended Dec 31, 2012 (CY'12)were Rs.122,529 million [CY 11: Sales Rs.99,700 million] Sales growth of 23% in rupee terms over the corresponding year.The EBITDA without considering exceptional items was 15% of Sales at Rs.18,227 million. Profit After Tax was Rs.9,228 Mn. PAT for CY'12 was 8% of sales after incorporating one time charges of Rs.1,860 Mn and Rs.1,652 Mn on account of recall and forex MTM mentioned earlier. Commenting on the business results for the quarter, Mr. Arun Sawhney, CEO & Managing Director, Ranbaxy, said, "2012 was a mixed year for us. While we delivered our strongest ever sales performance monetizing our major key product opportunities, we also faced challenges, primarily the recall of atorvastatin in the US market at the end of the year. We took a proactive action to voluntarily recall atorvastatin from the US market in the best interest of patients. We have since taken several Corrective and Preventive Actions (CAPA) and commenced shipment of the API to our formulation facility in the US." Adding further, Mr. Arun Sawhney said, "We have made good progress on the Consent Decree honouring all our commitments till date. We continue to remain confident of monetizing our large ANDAs. In line with our focus on differentiated products and branded strategy for the developed markets, the company launched Absorica, as an NDA in the dermatological segment in USA. We have taken significant steps which will position Ranbaxy to emerge stronger with a competitive edge, in the rapidly changing business climate." Key Highlights/Developments Base business sales in Q4'12 and CY'12 improved by double digits over the corresponding period.Sales grew in major emerging markets of India, Africa and East Europe & CIS over Q4'11. For CY'12, sales improved in all major emerging and developed markets. Also significant was the launch of India's first new drug, Synriam, for the treatment of Plasmodium falciparum malaria, in adults. Synriam featured amongst the top new product launches in the Indian Pharmaceuticals Market (IPM). With the launch of pioglitazone hydrochloride in the US as an authorised generic (AG), Ranbaxy gained over 30% market share.The leadership in Atorvastatin + Amlodipine (Caduet AG) post exclusivity was also maintained. India sales growth at 12% was faster than IPM sales growth. bUnder the Hybrid Business Model, Ranbaxy and Daiichi Sankyo Co. Limited (DS) further strengthened collaboration with the integration of their businesses in Thailand. During Q4'12, 15 regulatory agency inspections from the US FDA, EU Countries/ EMEA, Germany, South Africa and India were conducted at Ranbaxy's global manufacturing sites.In January 2012, Ranbaxy announced court approval of the Consent Decree (CD) filed with the US Food and Drug Administration (FDA); progress on the implementation of the Consent Decree has been per plan. Ranbaxy received approval to set up a Greenfield manufacturing facility by the Government of Malaysia which will significantly enhance the existing manufacturing capacity and help catering the ASEAN region. Earlier during the year, the Company established a new manufacturing base in Morocco, paving the way for a direct business presence in North Africa. Emerging markets contributed Rs.13,628 Mn accounting for ~51% of total sales during the quarter and 41% during the year. Developed markets recorded Rs.10,938 Mn of sales and contributed 41% to total sales for the Company during the quarter and 53% during the year. API and others accounted for the rest of the revenue. In North America sales for the quarter were Rs.8,510 Mn. The region recorded sales of Rs.53,336 Mn for the year, a growth of 28% aided by strong exclusivity sales of Atorvastatin and Amlodipine + Atorvastatin, and post exclusivity sales of these molecules. In India (including Sri Lanka and CHC)sales for the Quarter were Rs.5,418 Mn, up 12% from the corresponding quarter. The IPM slowed down to ~9% growth levels during the Quarter and 11% for the year. The Company expects to achieve sales of over Rs. 120 Bn in 2013, while also growing its base business by over 10%. ]]> <![CDATA[ India successfully thwarted â€œHarmonizationâ€?]]> https://biospectrumindia.com/news/95/3117/-india-successfully-thwarted-harmonization.html https://biospectrumindia.com/news/95/3117/-india-successfully-thwarted-harmonization.html Tue, 30 Nov -001 00:00:00 +0553 India has successfully thwarted Big Pharma's attempt to influence norm-setting for medicines in the resolution passed recently at the World Health Assembly in Geneva. International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH), is pharma industry initiative. The ISH initiative, harmonization of technical requirements for registrations of pharmaceuticals for human use by developing appropriate norms and standards taking into account the standards created by existing regional and international initiatives in the resolution was protested by India and several other countries. Such references dropped before the resolution on regulatory system strengthening for medical products was adopted. "The WHO guidelines are advisory in nature. But if a resolution is adopted, it becomes binding on the member countries. We cannot be party to a resolution where the language is not clear. What exactly do you mean by convergence or harmonization of regulation? Who will harmonize with whom? The needs of different countries are different," said R K Jain, additional secretary in the health ministry. He, along with V G Somani of Central Drug Standards Control Organization (CDSCO), negotiated on India's behalf. Civil society organizations working for greater access to medicines are pleased with the Indian initiative. According to them, "harmonization", in this context, was just a euphemism for setting of industry-led standards which favour the interests of transnational pharmaceutical corporations and their push to weaken competition from generic medicines. Civil society groups like Medicus Mundi and the People's Health Movement had in their letter to WHO pointed out that while ICH sought to raise the bar on acceptable manufacturing standards and to globalize these, higher standards, beyond a point, did not add to the quality of the medicines or public health outcomes. "It adds to the cost of manufacturing and is a barrier to the entry of generics," stated the letter. ]]> <![CDATA[India invests 0.65% of GDP on R&D in science and technology ]]> https://biospectrumindia.com/news/95/3124/india-invests-0-65-of-gdp-on-rd-in-science-and-technology-.html https://biospectrumindia.com/news/95/3124/india-invests-0-65-of-gdp-on-rd-in-science-and-technology-.html Tue, 30 Nov -001 00:00:00 +0553 India published 65,487 research articles compared to 3,30,818 by China in 2010. However, during the period 2006-10 the total number of research publications was 2,60,696 for India and 13,02,177 for China, according to a study report from Elsevier, a global publisher of scientific research. The study commissioned by the Department of Science and Technology on International Comparative Performance of India's Scientific Research provides details of competencies of research publications in 16 major scientific fields in terms of citation impact with India having a higher value of 0.68 as compared to 0.53 of China during 2006-10. Sharing the highlights of the study, Mr S.Jaipal Reddy, Union Minister of Science &Technology and Earth Sciences said, "The present level of investment in the country for Research and Development (R&D) in science and technology sector is 0.88 percent of GDP of which 0.65 percent is contributed by public sector. This is similar to the public investment in most other countries which is in the range of 0.7-1.0 percent. However, the private investment in R&D as percentage of GDP in India is 0.23 percent which has not kept pace with many developed and emerging countries in the world. There is no lack of dedicated scientific personnel in the country. The present scenario calls for enhanced participation from the private sector to keep up the pace of development in Science &Technology. The percentage of GDP allocated to scientific research has remained 0.88 percent during the 11th Five Year Plan period. The government aims at increasing the total R&D expenditure as percentage of GDP to 2 percent by the end of 12th plan period from the current level of 0.88 percent. This is more than double the expenditure over the past years and represents a significant allocation of resources considering the overall resources of the country. The Government proposes to achieve the targeted goal during the XII Plan period through various measures such as policy changes, increase in investment in R&D including by Industry and Strategic sectors, expansion of basic science infrastructure, aligning S&T to development needs like food and health care, evolving new models of public-private partnership in scientific research, encouraging international collaboration etc. ]]> <![CDATA[ Innovation to drive the agenda at the 11th edition of BioAsia from February 17 to 19, 2014]]> https://biospectrumindia.com/news/95/3126/-innovation-to-drive-the-agenda-at-the-11th-edition-of-bioasia-from-february-17-to-19-2014.html https://biospectrumindia.com/news/95/3126/-innovation-to-drive-the-agenda-at-the-11th-edition-of-bioasia-from-february-17-to-19-2014.html Tue, 30 Nov -001 00:00:00 +0553 The 11th annual international lifesciences conference, BioAsia - the Global Biobusiness Forum, will be held in Hyderabad from February 17 to 19, 2014 at the Hyderabad International Convention Centre. BioAsia has emerged as the industry forum in the region for the lifesciences industry and hence the 11th edition of BioAsia is dedicated to the most cogent theme - 'Innovate. Evolve'. BioAsia's focus on 'Innovation in lifesciences' will address the increasing disease burden, and the growing need for more efficacious and affordable healthcare solutions. Panel discussions hosting global industry leaders will deliberate on the path breaking solutions for the sector, from innovative products to models that reduce R&D cost while increasing efficiencies, and innovative financing models, that promote new business ideas. The goal is to highlight innovation as the driver of the lifesciences economy in the coming years. In addition, a parallel event AgBioAsia focusing on health and nutrition with the theme of 'Harnessing the potential of the global nutraceutical market' will be hosted by the Government of Andhra Pradesh in partnership with the International Crops Research Institute for the Semi Arid Tropics (ICRISAT) and the Federation of Asian Biotech Associations (FABA). Talking about BioAsia 2014, Mr Shakthi Nagappan, CEO, BioAsia said, "BioAsia has always been about coming together to discuss the most relevant and futuristic trends around lifesciences. Exclusive and interesting topics pertaining to the need of the changing times have been discussed at this forum in the past. This year BioAsia takes another leap by bringing innovation at the center stage of discussion". "Lifescience is an innovation intense industry. Traditionally, the Asian lifesciences businesses are centered around established markets for their clearly defined products or services with little experimentation, which to a great extent can be attributed to low risk appetite investor climate. However, the situation is changing and there is an increasing recognition that innovation is essential for sustenance and growth, even within established businesses. Hence, we are confident that the global business leaders, with demonstrated innovative capabilities coming together at BioAsia 2014 will add significant impetus to the India's innovation path" he added. For more than a decade, BioAsia has built a formidable reputation for convening a high caliber network of lifescience executives to exchange views, analyze, showcase, explore and connect strengths that extend the visible horizons in the sector. BioAsia 2014, hosted by Government of Andhra Pradesh with the support of FABA and Pharmaceuticals Export Promotion Council of India (Pharmexcil) will feature comprehensive breakout sessions on Bio-energy, Drug Discovery, Bio-IT, Bio-therapeutics, Regenerative Medicine and Medical Electronics and Devices to discuss the contemporary developments in science & technology. ]]> <![CDATA[Intas pharmaceutical launched cheaper generic blood cancer drug ]]> https://biospectrumindia.com/news/95/3234/intas-pharmaceutical-launched-cheaper-generic-blood-cancer-drug-.html https://biospectrumindia.com/news/95/3234/intas-pharmaceutical-launched-cheaper-generic-blood-cancer-drug-.html Tue, 30 Nov -001 00:00:00 +0553 The company's product Azadine, which is a generic version of US-based Celgene Corporation's Vidaza, is used for treating MDS (Myelodysplastic Syndrome) and AML (Acute Myelogenous Leukemia), types of cancer. MDS is a type of cancer in which the bone marrow does not make enough healthy blood cells and there are abnormal cells in the blood and/or in the bone marrow. Advanced stages of MDS may lead to AML. Azacitidine is the only drug which has been shown to prolong overall survival duration and time to transformation into AML, increase response rate, reduce transfusion burden and improve quality of life. Intas is manufacturing Azadine at its Ahmedabad facility, which operates in compliance with global regulatory standards like USFDA, MHRA and ANVISA. The company has a portfolio of drugs catering to various therepeutic segments including central nervous system (CNS), cardiovascular system (CVS) and diabetes. ]]> <![CDATA[Aarti Industries gets High Court's nod for Anushakti Chemicals demerger ]]> https://biospectrumindia.com/news/95/3280/aarti-industries-gets-high-courts-nod-for-anushakti-chemicals-demerger-.html https://biospectrumindia.com/news/95/3280/aarti-industries-gets-high-courts-nod-for-anushakti-chemicals-demerger-.html Tue, 30 Nov -001 00:00:00 +0553 Aarti Industries, a leading manufacturer and exporter of chemicals and pharmaceuticals, said it has received the required approval from the High Courts for arrangement of the demerger of manufacturing business undertaking of Anushakti Chemicals and Drugs Ltd (Anushakti) into itself. "We have received the required approval from the Gujarat High Court and Bombay High Court for the demerger scheme. With this the scheme becomes effective with effect from April 1, 2012. Merged financial of Aarti including Anushakti will be approved by the board at the upcoming board meeting to be held on 16th May, 2013," Aarti Industries chairman and managing director, Rajendra Gogri said. The company, in its endeavour to consolidate operations and as a part of their overall corporate restructuring, had proposed to demerge the manufacturing operations of its associate company Anushakti into Aarti Industries w.e.f 1st April 2012. Shares of AIL are listed on the NSE and BSE. Anushakti is mainly engaged into manufacturing of various speciality chemicals with applications into end-user segments of performance chemicals, agrochemicals and pharmaceuticals. The company has its manufacturing units at in the state of Gujarat and Maharashtra & a Pharma R&D Centre in the State of Maharashtra. This would help to increase the volumes of existing range of products and also facilitate addition of newer products with divergent end users into fuel, additives, polymers etc., having high growth possibilities. The consolidation will help reduce the intercompany transaction and improve the overall operating margin of the merged entity. Thus top line, EBIDTA and bottom line of merged entity will increase. Aarti's Board shall approve consolidated figures for the year ended March, 2013 on 16th May, 2013. For the financial year ended March 31, 2012, Anushakti's manufacturing division had posted a turnover of Rs 339.5 crore (of which exports were Rs 99.2 crore) and profit before tax for FY2011-12 has been Rs 37 crore. Gross block and net block as at March 31, 2012 were Rs 165 crore and Rs 96.3 crore, respectively. Aarti Industries Ltd, incorporated in the year 1984 and listed on stock exchanges in 1992, and offers over 150 products and is the market leader in more than 75% of its top 50 products. AIL has 16 manufacturing units spread across Gujarat, Maharashtra, Madhya Pradesh and Silvassa. It is a leading supplier to global manufacturers of Dyes, Pigments, Agrochemicals, Pharmaceuticals & rubber chemicals. ]]> <![CDATA[US FDA inspects Divis Laboratories' ]]> https://biospectrumindia.com/news/95/3342/us-fda-inspects-divis-laboratories-.html https://biospectrumindia.com/news/95/3342/us-fda-inspects-divis-laboratories-.html Tue, 30 Nov -001 00:00:00 +0553 The Unit II at village Chippada near Visakhapatnam has had an inspection by the United States Food and Drug Administration (USFDA) with no major observations, Divis Laboratories said. "The audit concluded with one observation primarily about further improvement of existing procedure. The purpose of this inspection was for custom manufactured product," it added. Divis undertakes custom manufacture of active pharmaceutical ingredients (APIs) and advanced intermediates. ]]> <![CDATA[Zoledronic acid (5mg/100mL) injection and lamotrigine XL launched during the quarter]]> https://biospectrumindia.com/news/95/3364/zoledronic-acid-5mg-100ml-injection-and-lamotrigine-xl-launched-during-the-quarter.html https://biospectrumindia.com/news/95/3364/zoledronic-acid-5mg-100ml-injection-and-lamotrigine-xl-launched-during-the-quarter.html Tue, 30 Nov -001 00:00:00 +0553 Dr. Reddy's Laboratories ltd. (NYSE: RDY) announced consolidated financial results for the quarter ended June, 2013 under International Financial Reporting Standards (IFRS). As per the report it was clearly visible that gross profit margin for Q1 FY14 stood at 52.8%, however marginal drop of 50 basis points compared to Q1 FY13. GG gross margin improved primarily on account of higher contribution from new product launches in North America Generics, where as PSAI gross margin declined. Selling, general and administration (SG$A) at 8.8 billion increased YoY by only 6%. SG&A expenses for Q1 FY14 stood at 30.95 to sales as compared to 32.6% to sales in @1 FY13. Focussing on the research and development expenses it is estimated at 2.4 billion, YOY growth of 55%, 8.5% revenues in Q1 FY13. The increase is in line with the increased focus on complex formulations, differentiated portfolios and biosimilars. Key highlights: - Net finance expense is at 70 million in Q1 FY14 compared to 212 million in Q1 FY13. - Profit after Tax in Q1 FY14 at 3.6 billion, 13% of revenues with a YoY growth of 7% - Capital expenditure for Q1 FY14 is 2.0 billion. - Revenues from Emerging markets ( Which include Russia, CIS countries and RoW territories) for Q1 FY14 at 6.0 billion, YoY growth of 9%. - Revenues from India for Q1 FY14 at 3.5 million remained flat YoY. - Implementation of the new Pricing Policy 2012, which led to destocking in the trade, coupled with the Maharshtra trade strike had an adverse effect on the revenues for the quarter. ]]> <![CDATA[NEERI to have its own biotech park soon]]> https://biospectrumindia.com/news/95/3381/neeri-to-have-its-own-biotech-park-soon.html https://biospectrumindia.com/news/95/3381/neeri-to-have-its-own-biotech-park-soon.html Tue, 30 Nov -001 00:00:00 +0553 The union minister for science and technology, Dr Harsh Vardhan after attending a series of events at the National Environmental Engineering Research Institute (CSIR-NEERI: a wing of the Council of Scientific and Industrial Research) in Nagpur on June 05,mentioned, "We must join the growing world community of safety and environment conscious consumers who are aware of the cradle to grave implications of the production of whatever they buy. We must also conserve with a view to tomorrow -spare enough for the coming generations." Dr Harsh Vardhan went around the facilities of CSIR-NEERI, an institution he dubbed as the "gold standard" among comparable foundations all over the world. He inaugurated a "Harit Sanghralaya", flagged off the MEMCL and laid the foundation of a Biotechnology Park which is to come up with the objective of developing a state-of-art technology development laboratory for transformation of lab-scale processes to demonstrable technologies. The achievements of CSIR-NEERI have been displayed under 12 themes: "Glorious past", "Air environment", "Water environment", "Wastewater technology", "Eco-restoration", "Environment and health", "Solid and hazardous waste management", "Waste to wealth", "Renewable energy", "Climate change", "Analytical instruments" and "Environmental modelling". The objective is to promote green solutions in the air, water, energy and other environmental sectors at local, regional, and international levels. The Harit Sangrahalaya proposes to open its doors to individuals, industries and organisations to adopt best eco-friendly practices, to raise their contribution to sustainable development. Its theme is: "Join us and be part of a sustainable future". Dr Harsh Vardhan described the museum as a "gift to the people of Nagpur" who are already famous for their high degree of cultural awareness. It includes a "Kids Section" under which the virtue of Biodiversity has been showcased with beautiful illustrations. Some working models have been prepared based on the CSIR-NEERI technologies and placed in the Sangrahalaya to highlight the Electrolytic defluoridation process used to remove fluoride from water, phytorid technology for sewage treatment, "NEERI-ZAR" portable instant water filter, solid waste to biogas plant, decolourisation of effluent of textile industry, and common effluent treatment plant for industrial wastewater treatment. "I hope that through this museum the people of Nagpur, who are dwelling at the hub of Maharasthra and India's industrial growth, would see for themselves how they can themselves play a role in striking a balance between the demands and responsibilities of modern living. I congratulate the scientists and technologists of CSIR-NEERI for coming up with this wonderful idea," he said. The MEMCL is capable of real time sampling, analysis and control of air pollution from sources through flue gas treatability studies. It is equipped with a number of innovative technologies that enhances the CSIR-NEERI's air monitoring capabilities. "I have suggested to the Director, CSIR-NEERI and his able team that instead of keeping MEMCL confined to just Nagpur they should send it to all the major cities because every one of them is suffering under the burden of air pollution. CSIR-NEERI's good name will be leveraged on a nationwide scale and resultantly all the state governments will adopt its air cleansing proposals on a war footing by the time of next year's World Environment Day," he said. The proposed Biotechnology Park Project envisages the utilisation of municipal solid waste (MSW) and organic biomass as raw material for bio-fuels to address the waste management issues at reduced cost. The project would deploy biological and thermal processing options to propose the most economic and strategic option. Dr Harsh Vardhan said that waste management is one of the key priorities of the Narendra Modi government's environment policy. The long-term goal for the development is to become a recycling society that uses waste as a resource. Multitudes of the processes are available for utilization of waste for bio-fuels, he added. ]]> <![CDATA[Wockhardt Q1FY14 Net Sales at Rs.1358 crore and PAT at Rs.324 crore]]> https://biospectrumindia.com/news/95/3390/wockhardt-q1fy14-net-sales-at-rs-1358-crore-and-pat-at-rs-324-crore.html https://biospectrumindia.com/news/95/3390/wockhardt-q1fy14-net-sales-at-rs-1358-crore-and-pat-at-rs-324-crore.html Tue, 30 Nov -001 00:00:00 +0553 Wockhardt from its quarter end result filed it was clealry observed that Wockhardt increased its research spent significantly and the same is now at 7.2% at Rs. 98 crores and including capital expenditure is at 7.7% to sales for the quarter. Wockhardt has as of now filed 4 new product applications with USFDA during the quarter. Capital expenditure of Rs. 68 crore was incurred during the quarter. Business Highlights: International Business contributed 82% of the Total Revenues during the quarter. Wockhardt's US business recorded a growth of 11% in Q1FY14 and contributed 53% of the Global Revenues for Wockhardt. The UK business recorded a growth of 1% IN Q1FY14. The irish market recorded decline of 31%. The India business grew by 3% and the Emerging Market business declined by 28% in Q1FY14 ]]> <![CDATA[First in Asia, Intra Operative 3D Radioguided Surgery System at HCG]]> https://biospectrumindia.com/news/95/3395/first-in-asia-intra-operative-3d-radioguided-surgery-system-at-hcg.html https://biospectrumindia.com/news/95/3395/first-in-asia-intra-operative-3d-radioguided-surgery-system-at-hcg.html Tue, 30 Nov -001 00:00:00 +0553 HealthCare Global Enterprises ltd (HCG) headquartered in Banglore, is Asia's largest Cancer Care Network, with 27 Cancer Centres, 4 tertiary care centres and 4 Fertility Care Centres. HCG has redefined the future of healthcare in India by designing, building and managing centres with a committed vision. The vision of HCG is to make high quality healthcare accessible to al lby adopting global innovations. Dr. Joerg Traub, Inventor and Founder, SurgicEye GmbH, said, "I am impressed by the quality of service and the patient centered approach of HCG and I'm convinced that HCG is the best location for the first declipseSPECT installation in Asia. The declipeSPECT will add one more innovation to HCG's high quality service, providing 3D imaging and guidance support for least invasive surgery and quality assurance in the operating room to document the complete removal." Dr Mahesh Bandemegal, Consultant, Surgical Oncologist, HCG, said, "The usage and benefits of declipseSPECT are varied. This new technology helps us to identify and image the senttinel node intraoperatively. This will help us in accurate localisation of Lymph node with smaller incisions. Mainly used for Breast cancer, Skin cancer, Oral Cancer, Gynecological. It is the most accurate way of detecting and avoiding false negativity. The declipseSpect is a freehand SPECT device intraoperative 3D imaging for radioguided surgery. ]]> <![CDATA[Apollo goes mobile for excellence in Customer Service Management]]> https://biospectrumindia.com/news/95/3403/apollo-goes-mobile-for-excellence-in-customer-service-management.html https://biospectrumindia.com/news/95/3403/apollo-goes-mobile-for-excellence-in-customer-service-management.html Tue, 30 Nov -001 00:00:00 +0553 Understanding the limitations of its existing customer feedback system, Apollo recently partnered with American Megatrends India to go paperless and make efficient use of its manpower. American Megatrends India's FMS comes with a simple and apppealing iphone/Android application. Megatrends India has customised the FMS solution for Apollo and integrated it with its AIMS (American Megatrends Infrastructure Suite) solutions that allow the feedback to get escalated to respective deparments. Mr. Arvind Sivaramakrishnan, Chief Information Officer, Apollo Hospitals, commented, "The opinion and feedback of customers are invaluable to us. We needed a solution that could capture and strategically analyze the collected feedback. We are glad to have partnered with American Megatrends India. The company's Feedback Management System Has provided a smart and user-friendly solution which has not only helped us in capturing customers feedback, but also in effectively engaging with them." On the successful deployment of this project, Mr. Sridharan Mani, Director and CEO, American Megatrends India, expressed, "It is a huge honour to get this project from Apollo. This project bears testimony to Apollo's endeavors to continually better its customer management. This project has set a new benchmark for the customer service excellence in hospitals, in India. We look forward to extending this solution to other sectors as well." ]]> <![CDATA[ Impact of Global Sugar Consumption ]]> https://biospectrumindia.com/reports-white-papers/95/3410/-impact-of-global-sugar-consumption-.html https://biospectrumindia.com/reports-white-papers/95/3410/-impact-of-global-sugar-consumption-.html Tue, 30 Nov -001 00:00:00 +0553 The credit Suisse Research Institute released a report entitled "Sugar: Consumption at a Crossroads." The report explores the medical, economic, consumer, corporate and public policy elements of global sugar consumption an the impact for investors as focus on this area intensifies. The fast growth of diabetes type II, metabolic syndrome, obesity and their nutritional issues are arguably this century's primary social health concern. The report explores the impact of 'sugar and sweeteners' on our diets and leverages the expertise of over 20 research ananlyst and industry experts to assess the impact on companies as the landscape of consumer preferences and public policy is potentially redrawn. To provide new insights on the debate, the report includes a proprietary survey of general practitioners in the US, Europe and Asia. The survey found that 90% of the doctors surveyed believed that the sharp growth in type II diabetes and the current obesity epidemic are strongly linked to excess sugar consumption. "Although casuality is difficult to prove in this area, with such a high percentage of doctors in our proprietary survey confident of this strong link, we cannot ignore the significance and the implications for society and our economy," says Stefano Natella, Co- Head of Securities Research and Analytics and an author of the study. Among the potential public responses, taxation might be the most effective but also less likely with the exception of Mexico and some European countries. However the risk of public intervention and increasing public awareness will force companies to adapt as consumer gradually move towards healthier options that utilize high-intensity natural sweetners. This provide challenges and opportunities for both companies and investors. "The scale and cost of the type II diabetes and obesity epidemic leaves little question as to the need for change. This will bring new investment opportunities with winners and losers," said Giles Keating, Head of Research for Private Banking and Wealth Management. This report provides investors with insight into an emerging megatrend that will help shape the evolution of the investment world. ]]> <![CDATA[Health Ministers adopt New Delhi Declaration to combating high blood pressure]]> https://biospectrumindia.com/news/95/3417/health-ministers-adopt-new-delhi-declaration-to-combating-high-blood-pressure.html https://biospectrumindia.com/news/95/3417/health-ministers-adopt-new-delhi-declaration-to-combating-high-blood-pressure.html Tue, 30 Nov -001 00:00:00 +0553 Health Ministers from WHO's South-East Asia Region adopted the "New Delhi Declaration on High Blood Pressure". The Health Ministers committed to strive towards measurable reduction in the prevalence of hypertension in the region by 2025. Hypertension is the leading risk factor for mortality worldwide, causing 9 million deaths each year. In South-East Asia every third adult is affected by hypertension with an increased risk of heart disease, stroke and kidney failure. The poor are disproportionately affected by hypertension. "High blood pressure is a strong and reliable warning signal that health is at risk and that something needs to be done. But it often shows no symptoms for years and by the time symptoms appear, cardiovascular disease is advanced and the risk of heart attack or stroke is increased" said WHO Director General, Dr Margaret Chan. "The public health challenge is to get more people routinely tested early to enable proper management of high blood pressure through life style change or medication" she added. India's Minister for Health and family Welfare Mr Ghulam Nabi Azad highlighted that India is soon to be certified as a polio free country. He acknowledged WHO undivided support to the Government's strong political will and leadership at the highest levels. "India is called the 'pharmacy of the world' for producing high quality and affordble generic drugs which have substantially brought down the prices" he said. He further added "India also has several institutions that excel in public health and are open to neighboring countries in the area of capacity building aimed at increasing skilled human resources in health. we have developed indigineous vaccines and testing reagents for H1N1 and other influenzas; indigenous vaccine for Japanese Encephalitis and a magnifying device for cervical cancer screening in the field." through the New Delhi Declaration, ministers commited to: - Multisectorila collaboration with key stakeholders and to empower people to make healthy choices for health lives; - develop multisectoral policies to promote physical activity and healthy diet and eliminate exposure to tobacco and harmful use of alcohol; - implement salt reduction strategies, regulate the food industry including food labeling, and reduction of salt in processed foods - legislate for 100% tobacco smoke-free settings - promote universal access to prevention, treatment and care for the integrated management of noncommunicable diseases including hypertension, through a primary health care approach. India hosted the 31st meeting of Ministers of Health of the WHo South-East Asia Region. the Ministers reviewed progress on decisions and recommendations from previous meetings. ]]> <![CDATA[Glenmark receives final ANDA approval for Desoximetasone Ointment USP, 0.25%]]> https://biospectrumindia.com/news/95/3439/glenmark-receives-final-anda-approval-for-desoximetasone-ointment-usp-0-25.html https://biospectrumindia.com/news/95/3439/glenmark-receives-final-anda-approval-for-desoximetasone-ointment-usp-0-25.html Tue, 30 Nov -001 00:00:00 +0553 Glenmark Generics Inc. , USA the subsidiary of Glenmark Generics Limited has been granted final abbreviated new drug approval (ANDA) from the United States and Drug Administration (U.S FDA) for Desoximetasone Ointment USP, 0.25% their generic version of Topicort by taro Pharmaceuticals USA Inc and shipping will commence immediately. Desoximetasone Ointment is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Glenmarks current portfolio consists of 89 products authorized for distribution in the U.S marketplace and 54 ANDA's pending approval with the U.S FDA. in addition to these internal filings, GGI continues to identify and partnership to supplement and accelerate the growth of the existing pipeline and portfolio. ]]> <![CDATA[Funding for Indo-Finnish collaboration]]> https://biospectrumindia.com/news/95/3452/funding-for-indo-finnish-collaboration.html https://biospectrumindia.com/news/95/3452/funding-for-indo-finnish-collaboration.html Tue, 30 Nov -001 00:00:00 +0553 Funding is available for both industrial projects and projects of research organisations. Collaborative projects between industry and academia are encouraged. In case of academic research, projects that engage a technology developer and a technology end-user/first customer are strongly recommended. The aim is to launch ambitious joint projects of a high international standard between Finnish and Indian organisations. Potential projects will be funded by Tekes in Finland, and by DBT in partnership with BIRAC in India. The joint projects must meet the requirements of the funding organisations. In the Finnish part of the project, the general funding terms of Tekes will be applied, and in the Indian part of the project, the general funding terms of DBT/BIRAC will be applied. Launch of the call: 11 Sept. 2013Dead-line for project proposals: 24 January 2014Funding decisions: latest in June 2014 The projects funded in this call are expected to recognise a real need and aim to solve a relevant problem in India or globally. The projects must be Finnish-Indian joint projects with a common project plan and they need to build up Finnish-Indian partnerships in order to enhance benefits to come for both Indian and Finnish economic life and society. At least one organisation from Finland and one organisation from India must be involved as partners. The projects are expected to be multidisciplinary, combining e.g. health technology or diagnostics expertise with bio-IT knowledge and mobile technologies. Understanding the user needs and how the solution will benefit the patient or the customer will be crucial. Projects may focus on many different applications including but not restricted to e.g. the following: technologies and solutions for health and well-being. medical devices, diagnostics and healthcare technologies; digital and mobile solutions for these. utilisation of big data for developing health innovations. environmental monitoring with impact on health and well-being. The projects may aim to develop affordable solutions for low-resource settings, e.g. Indian rural needs, or focus on higher-end products and services. Total solutions that innovatively take into account different challenges related to a problem will be favoured. Engaging end-users or customers in the projects is strongly encouraged. ]]> <![CDATA[Avesthagen Pharma signs a pact with Elpen Pharmaceuticals ]]> https://biospectrumindia.com/news/95/3480/avesthagen-pharma-signs-a-pact-with-elpen-pharmaceuticals-.html https://biospectrumindia.com/news/95/3480/avesthagen-pharma-signs-a-pact-with-elpen-pharmaceuticals-.html Tue, 30 Nov -001 00:00:00 +0553 Avesthagen Pharma AG (APAG) has announced an agreement with Elpen Pharmaceutical Co. Inc, a leader in Life-sciences for the distribution of AVDESPTM, a biosimilar product in seven EU and six non-EU territories namely Greece, Cyprus, Bulgaria, Romania, Croatia, Slovenia, Slovakia, Serbia, Bosnia, FRYOM, Albania, Montenegro and Kosovo with a collective population base of over 70 million. AVDESPTM, a Biosimilar for Darbepoetin alfa Aranesp will be used for the treatment of anaemia resulting from chronic kidney disorders and cancer chemotherapy. "We are excited about this alliance as we start our marketing in some most interesting countries, it will give us an opportunity to know these markets and interact with its people," said Dr Villo Morawala - Patell, Chairperson, APAG. "The company is commited to deliver affordable healthcare for humanity," added Dr Patell. APAG is currently engaged with many other opportunities for a number of its 'Biosimilars' and 'Biobetters' in several countries. APAG is working with different outsourcing organizations to make sure the product come to the market at the earliest. APAG has identified Syngene International Ltd for fill and finish; Kemwell Bioharma as a CMO (Contract Manufacturing Organization) ; and PRA International, a global CRO to conduct and carry out the Phase I Clinical Trial in The Netherlands followed by Phase III in India. This Deal is of primary importance as APAG establishes its presence as a developer and marketer of its significant Biosimilar pipeline. Avesthagen Pharma Ag (APAG) and its 100% owned subsidiary Avesthagen Pharma india Pvt Ltd (APIPL) is a key player in the targeted therapeutic soace. Its journey started as a spin-out from Avesthagen Limited carrying a formidable portfolio of 8 biosimilar drugs. Both companies stressed that they are excited with the new deal, which marks the begining of a long and fruitful co-operation. ]]> <![CDATA[gffshjgdjhkf]]> https://biospectrumindia.com/news/95/3482/gffshjgdjhkf.html https://biospectrumindia.com/news/95/3482/gffshjgdjhkf.html Tue, 30 Nov -001 00:00:00 +0553 fgjhkjlh ]]> <![CDATA[Cardioband Annuloplasty System for transcatheter mitral repair show promising preliminary results]]> https://biospectrumindia.com/news/95/3487/cardioband-annuloplasty-system-for-transcatheter-mitral-repair-show-promising-preliminary-results.html https://biospectrumindia.com/news/95/3487/cardioband-annuloplasty-system-for-transcatheter-mitral-repair-show-promising-preliminary-results.html Tue, 30 Nov -001 00:00:00 +0553 Valtech Cardio ltd, a medical device company that develops solutions for mitral valve repair and replacement, announced today that 11 patients have been treated with the compnay's transcatheter Cardioband Annuloplasty System in three leading European medical centers. The Cardioband device enables transcatheter Mitral Regurgitation (MR) repair, thereby avoiding open heart surgery and the use of cardiac bypass machine. Another advantage is that the size of the Cardioband is fitted while the heart is beating which optimizes the reults of the repair. Importantly, the form and clinical function of the Cardioband closely replicates that of the annuloplasty rings that are today the standard-of-care in surgery. The patients were treated as part of an ongoing multi-center study at the Asklepios Klinik St. George Heart Center in Hamburg, Bichat-Claude Bernard Hospital in Paris and San Raffaele Hospital in Milan. The objective is to study the safety of Valtech's Transfemoral Cardioband Annuloplasty from functional MR who are at high risk for open heart surgery. The study focusses on overall rate of Major ardiovascular adverse events (MACE) until hospital discharge and at post-operative 30 days. Dr. Francesco Maisano, Valtech's Chief Medical Officer, commented: "The safety profile of the device is impressive. Throughout these eleven procedures, the Cardioband device has demonstrated an excellent safety profile with no MACE to date." Dr. Maisano added, "Cardioband is the most promising valve repair technology. Early outcomes are extremely favorable with profound reduction of MR in most patients." All patients that have been implanted with the Cardioband system have experienced a reduction in the mitral valve annular size and an increase in coaptation length. To date, two patients have completed 6 months follow-up demonstrating a stable improvement from severe MR to mild MR; while nine patients were discharged with mild or even no MR. Prof. Vahanian, Principal Investigator at Bichat-Claude Bernard Hospital, Paris, who planted five patients noted, "We have been waiting for a long time for a transcatheter treatment for mitral regugitation that can reproduce an effective surgical technique. The preliminary results we now have with Cardioband suggest that the Cardioband can do it." Valtech Cardio plans to expand the study in the next few months by recruiting additional leading heart centers throughout Europe. Data from the trial will be used to support and obtain the CE Mark and other international regulatory approvals. Enrollment is expected to be completed in the first ahlf of 2014. ]]> <![CDATA[Mankind Is Entering New Era of Applied Organ Regeneration Science]]> https://biospectrumindia.com/news/95/3492/mankind-is-entering-new-era-of-applied-organ-regeneration-science.html https://biospectrumindia.com/news/95/3492/mankind-is-entering-new-era-of-applied-organ-regeneration-science.html Tue, 30 Nov -001 00:00:00 +0553 Dr Rongxiang Xu in a special ceremony delivered an in-depth presentation on how to initiate the human body's PRC regenerative life and the kickoff of the era of applied organ regeneration science. Dr. Xu further idnetified that organ regeneration science offers the guarntee of health and is the highesr ideal in basic and applied studies in human life science. Dr. Xu was the only international Laureate for this year's International Golden Biatec invention of "the ascientific route and solution for human regeneration and life extension." During the award ceremony, Dr. Xu began his discussion by providing an overview about the scientific missions announced by four former and present U.S. Presidents, Dr. Rongxiang Xu talked abotu the importance of entering the era for application of human organ regeneration science. He stated that: former U.S. President Nixon made a commitment in 1971 to use genes to conquer cancer. That quest was not ended until March 21, 2013, after dozens of years of study and validation, Professor Watson, the 'father of gene', announced that gene therapy study is of no value which many view as the end of the gene application era. According to Dr. Xu, some scientists who failed to create rteal stem cells have labeled fake pluripotent stem cells as genuine pluripotent stem cells therefore creating fraudulent conduct and misleading information which ruined the era of embryonic stem cell study first initiated under the Bush administration due to the fasle object used in so called stem cell study. Thsi year U.S. President Barack Obama encouraged the study of "damaged organ regenerartion" drugs, which is also the organ regeneration sceince route patented by Dr. Rongxiang Xu. President Obama did bring the direction of American life science development up to the era for application of organ regenration science. two years ago, in the University of Southern California (USC), USA, the Institute of Applied Science for Human Regeneration and Rejuvenation (IASHRR) was founded to initiate in advance the higher education of human organ regeneration science. Among Xu's organ regeneration technologies, the applied technology for skin organ regeneration has already been used in 73 countries for 25 years. In Dr. Xu's view, if the life of the human body's own PRC is initiated, then human diseases incurable by medicine will remarkably decrease, and mankind wuill enjoy an unexpected happier and healthier life. The energy of the human body will enhance unprecedentedly and human lifespan will be extended significantly. The fortune created by human beings will be unprecedentedly immeasurable. The world of human regenerative life will come into reality naturally. In order to benefit people worldwide with his invention and creation, Dr Xu is calling on the leaders of all countries to validate and utilize his life-saving technologies as soon as possible for the good of their nations. Dr. Xu has also called on relevant scientists and affected interest group in the organ regeneration science era to join the trend of boosting organ regeneration science, if they have no better technology than organ regeneration science and would like to apply organ regeneration science to stay healthy and increase longevity. Dr. Xu's goal is to work together with all national governments to accomplish the mission of enabling people worldwide to enjoy regenerative life. ]]> <![CDATA[Sanofi Pasteur announces vaccine discovery collaboration with the Bill & Melinda Gates Foundation]]> https://biospectrumindia.com/news/95/3493/sanofi-pasteur-announces-vaccine-discovery-collaboration-with-the-bill-melinda-gates-foundation.html https://biospectrumindia.com/news/95/3493/sanofi-pasteur-announces-vaccine-discovery-collaboration-with-the-bill-melinda-gates-foundation.html Tue, 30 Nov -001 00:00:00 +0553 Sanofi Pasteur, the vaccines division of Sanofi, announced today partnership with the Bill and Mellinda Gates Foundation to explore and develop new platforms and methods intended to accelerate vaccone R&D, particularly in areas of global health. The announcement was made at the Grand Challenges in Global Health meeting in Rio de Janeiro, Brazil during a session focused on affordable technologies for the devloping world. The conference initiated by the Gates Foundatuion was first held in 2003 to focus on persistent chalenges in improving health and development in poor countries. The vaccine Discovery Partnership (VxDP) is newly created, formal mechnaism by which the Gates Foundation can directly collaborate with Sanofi Pasteur and other vaccine-pharmaceutical companies across disease areas of interest. It provides an integrated, straight-forward and sustained relation based on a memorandum of understnading (MOU). "The MOU with the Gates Foundation facilitates our working together to de-risk novel concepts, technologies, platforms, and approches of mutual interest," explaining John Shiver, PhD, Senior VP of R&D for Sanofi Pasteur. "This program provides a mechanism to pursue R&D of new candidate vaccines for global health in preclinical and clinical phases up to and including Phase IIa clinical trials," he added. According to Shiver, the partnership allows the Gates Foundation and its pharmaceutical partners to accelerate the development of candidate vaccines for use in developing countries, while allowing the pharmaceutical partners to develop and test new technologies that also will advance their other R&D programs. This VxDP spearheaded by the Gates Foundation is expected to result in decreased cost and time required to develop successful vaccines. "Vaccines are one fo the most powerful tools to save and improve life," said Trevor Mundel, prsident of Global health at the Bill & mellinda gates Foundation. " This partnership will help accelerate research and development of effective and affordable vaccines that will ultimately benefit the world's poorest people and I'm pleased that Sanofi is contributing their expertise and resources." Further Mr Shiver added "These challenging projects would be difficult for any one organization to fund without Partnership". "The Gates Foundation is commited to supporting these pilots while we will contribute matching resources and expertise, as well as commit to guaranteeing that advances will support those who need them most through global access provisions." ]]> <![CDATA[Cadila Pharmaceuticals launches 'Mycidac-C']]> https://biospectrumindia.com/news/95/3520/cadila-pharmaceuticals-launches-mycidac-c.html https://biospectrumindia.com/news/95/3520/cadila-pharmaceuticals-launches-mycidac-c.html Tue, 30 Nov -001 00:00:00 +0553 Cadila Pharmaceuticals Limited, one of India's largest privately held pharmaceuticals company, has launched for the first time in the world, Mycidac-C, an affordable, unique and innovative drug for the treatment of Lung Cancer. Mycidac-C is an innovative research product for the patients suffering from Non Small Cell Lung Cancer (NSCLC). The drug has been approved for launch in India by the Drug Controller General of India (DCGI). It targets Desmocollin-3, a novel target. This is a first in the class active immunotherapy as well as drug targeting Desmocollin-3. It is a breakthrough in the management of squamous cell NSCLC. There has been no significant innovation in management of squamous NSCLC since the introduction of platinum containing doublet in 1983. Besides affordability and other advantages, Mycidac-C has no systemic side effects during the treatment. Mycidac-C is to be used with platinum containing doublet therapy. As per the WHO report, approximately 1.25 million people are diagnosed with lung cancer every year worldwide. Around 30% of them suffer from squamous NSCLC. Lung Cancer kills more people than the three next commonest cancers combined. This is in line with the vision of Shri I A Modi, Founder Chairman, Cadila Pharmaceuticals Ltd., to make affordable healthcare accessible to the masses for alleviating human suffering. Mycidac-C can be administered easily by trained paramedics, thus further reducing the cost of hospitalisation associated with other cancer therapy. Speaking at the launch, Dr Rajiv I Modi, Chairman and Managing Director of Cadila Pharmaceuticals said, "It has taken us over a decade, a huge investment and a dedicated research and development team to develop this unique drug. We expect it to be available in the Indian market by December 2013. Therafter, we will introduce it in other regions like SAARC countries and European markets over the next five years." Dr T. Ramasami, Secretary to the Government of India, Department of Science and technology also commented "Lung cancer is a major killer among all cancers. In this scenario Mycidac-C is a new hope for the patients suffering from lung cancer, particularly for Indian patients." ]]> <![CDATA[Jubilant Life Sciences receives ANDA approval for Spironolactone Tablets]]> https://biospectrumindia.com/news/95/3526/jubilant-life-sciences-receives-anda-approval-for-spironolactone-tablets.html https://biospectrumindia.com/news/95/3526/jubilant-life-sciences-receives-anda-approval-for-spironolactone-tablets.html Tue, 30 Nov -001 00:00:00 +0553 Jubilant Life Sciences Ltd, an integrated Pharmaceuticals and Life Sciences Company announced that it has received Abbreviated New Drug Application (ANDA) approval from the US Food and Drug Administration (USFDA) for Spironolactone Tablets, 25 mg, 50 mg and 100 mg, the generic version of Aldactone(r)(of GD Searle), which is used as a diuretic to treat fluid retention (edema) caused by congestive heart failure and cirrhosis of the liver. We expect to launch this product in Q1 FY15.The total market size for Spironolactone Tabletsas per IMS is US$ 87Million per annum. Jubilant has also received a tentative approval from the USFDA for Memantine Tablets, 5 mg and 10 mg, the generic version of Namenda(r) (of Forest Labs), which is used for treatment of moderate-to-severe Alzheimer's disease.We expect to launch this product post patent expiry in 2015. The total market size for Namenda(r)as per IMS is US$ 1.85 Billion per annum. As on December 31, 2013, Jubilant Life Sciences had a total of 689 filings for formulations of which 230 have been approved in various regionsglobally. This includes60 ANDAs filed in the US and 42 Dossier filings in Europe. ]]> <![CDATA[Distinguished Japanese Governor visits Transasia]]> https://biospectrumindia.com/news/95/3540/distinguished-japanese-governor-visits-transasia.html https://biospectrumindia.com/news/95/3540/distinguished-japanese-governor-visits-transasia.html Tue, 30 Nov -001 00:00:00 +0553 A high ranking Japanese delegation led by Governor of Shizuoka Perfecture, his Excellence Dr. Heita Kawakatsu paid a visit to Transasia Bio-Medicals Ltd. The meeting of the Japanese delegation served to build and deepen a trusting partnership between Japan and India. Coincidentally, this high level delegation visit was after the company won the Global Business Excellence Award 2013. During their one day visit, the high ranking delegation visited the Transasia factory at Seepz, Mumbai.The team was then taken through the manufacturing stations. Later during the day, Mr. Suresh Vazirani, Founder Chairman, Transasia and Mrs. Mala Vazirani, Executive Director, greeted the high level delegation at its head office, followed by a company presentation. The presentation highlighted the progress of the company across the world, future plans and corporate social responsibility activities. Thanking the company on behalf of the delegation His Excellence Dr. Heita Kawakatsu stated, " This is an awakening experience for us to to know about a gigantic company like Transasia. We whole-heartedly admire the work carried out by Transasia." Transasia has always been closely working with Japanese companies for the past 30 years. The company recently celebrated 20 years of progressive partnership with Sysmex, Japan, a leading Japanese hematology company. On the occasion, Mr. Suresh Vazirani, commented that, " Transasia is committed to growing its business in India and across the globe to provide affordable healthcare solutions for billions of people of emerging countries. We thank His Excellence Dr. Heita Kawakatsu and their delegation for their encouragement and guidance." ]]> <![CDATA[CHMP Recommends EU Approval of Piramal Imaging's NeuraCeq]]> https://biospectrumindia.com/news/95/3545/chmp-recommends-eu-approval-of-piramal-imagings-neuraceq.html https://biospectrumindia.com/news/95/3545/chmp-recommends-eu-approval-of-piramal-imagings-neuraceq.html Tue, 30 Nov -001 00:00:00 +0553 Piramal Imaging announced today the European Union's Committee for Medicinal Products for Human Use (CHMP) recommended approval of NeuraCeqTM (florbetaben 18F). The CHMP's recommendation will now be referred to the European Commission, for approval in the European Union (EU). NeuraCeqTM is a radiopharmaceutical indicated for Positron Emission Tomography (PET) imaging of neuritic beta-amyloid plaque densityin the brains of adult patients with cognitive impairment who are being evaluated for Alzheimer's disease (AD) and other causes of cognitive impairment. "This recommendation marks a major milestone for Piramal Imaging in our commitment to assist in the diagnosis of Alzheimer's disease and the development of novel tracers for PET imaging," said Dr. Ludger Dinkelborg, Director of the Board, Piramal Imaging SA. "This is a key step towards making this innovative type of imaging more accessible to healthcare providers and patients across Europe." Earlier this month, G8 health ministers held a dementia summit in London to discuss the challenges associated with this "major disease burden" that will likely affect one of every three people during their lifetimes. Despite its prevalence, the root cause of dementia is often misdiagnosed. As a result, a patient may not receive valuable treatments, or-if a patient does not have dementia-receive unnecessary and costlytreatments that demonstrate no benefit. Following the summit, the G8 participants issued a communiquÃ© that asked members to commit to "making timely diagnosis and early intervention feasible, affordable and cost effective." "Alzheimer's disease is a growing epidemic, with recent data suggesting more than six million people in Europe and 36 million people worldwide are living with Alzheimer's," said Dr. Swati Piramal, Vice Chairperson, Piramal Enterprises Ltd. "When Piramal Enterprises acquired Bayer HealthCare's molecular-imaging pipeline in 2012, we were excited about the potential for NeuraCeqTM as an adjunct to other diagnostic evaluations for dementia. It arms physicians with additional data to help reduce misdiagnosis of Alzheimer's diseaseand may have the potential to aid in earlier diagnosis and intervention. We look forward to hearing the European Commission's final decision." The CHMP's positive opinion was based on data from the pivotal phase III autopsy study, which showed that PET imaging with NeuraCeqTMdetects neuritic beta-amyloid in the brains of living subjects. The visual subject-level PET reading proposed for routine clinical practice compared to histopathology for the first 31 brains demonstrated 100 percent sensitivity and 86 percent specificity.In a post-hoc analysis in a larger population with 74 autopsied subjects, the sensitivity of the visual assessment was 98 percent and specificity was 89 percent. It is important to note, that a positive NeuraceqTM scan does not establish a diagnosis of Alzheimer's disease or other cognitive disorder. Additionally, the safety and effectiveness of NeuraceqTM have not been established for predicting the development of dementia or other neurologic conditions or monitoring responses to therapies. ]]> <![CDATA[ISCR releases Code for Conduct of Clinical Research in India]]> https://biospectrumindia.com/news/95/3564/iscr-releases-code-for-conduct-of-clinical-research-in-india.html https://biospectrumindia.com/news/95/3564/iscr-releases-code-for-conduct-of-clinical-research-in-india.html Tue, 30 Nov -001 00:00:00 +0553 "India must become an active centre for ethical clinical research and 'Health India' which emphasizes a collaborative approach by all disciplines of medicine should be our vision," said distinguished academician and clinical pharmacologist, Padmashree Prof. Ranjit Roy Chaudhury. He spoke as Guest of Honour at 'Research at Crossroads', the 7th Annual Conference being held by Indian Society of Clinical Research in Bangalore. Prof Chaudhury shared the fundamental features of his report 'Professor Ranjit Roy Chaudhury Expert Committee to Formulate Policy and Guidelines for Approval of New Drugs, Clinical Trials and Banning of Drugs'. Underlying the recommendations was the need to ensure a fair, transparent and honest framework that would build credibility for clinical research amongst the public. He also highlighted the need to create awareness about the contribution and value of ethically conducted research to healthcare. Prof Chaudhury acknowledged the support and contribution of ISCR towards developing the regulatory framework for clinical research. He hoped that in the near future, India would develop a transparent regulatory system for better management and conduct of clinical research in India and that there would be greater interaction between academia and industry. On the occasion, ISCR released the 'ISCR Code for Conduct of Clinical Research in India'. The 12 point patient-centric code applicable to all ISCR members reinforces their commitment to ethical, scientific and regulatory compliance while engaging in any clinical research activities. Earlier, Suneela Thatte, President, ISCR, stressed on the need to develop a clinical research agenda in India given the country's huge disease burden. 'India's emergence as a knowledge and innovation hub cannot happen without commitment to research and development. Affordable healthcare can only become a reality when patients benefit through local innovation,' she said. The inaugural session also had Dr Rebecca Li, Executive Director, MRCT Center at Harvard who spoke about the need to have all stakeholders involved in the regulatory process to ensure that clinical research in India develops to the potential it showed a few years ago. ]]> <![CDATA[ AstraZeneca should gift its Bangalore research center to Karnataka]]> https://biospectrumindia.com/news/95/3599/-astrazeneca-should-gift-its-bangalore-research-center-to-karnataka.html https://biospectrumindia.com/news/95/3599/-astrazeneca-should-gift-its-bangalore-research-center-to-karnataka.html Tue, 30 Nov -001 00:00:00 +0553 AstraZeneca took the national biotech community by surprise by its sudden announcement on January 30, 2014, that it will shut its research center in Bangalore. The swanky center, employing 165 scientists, who are trying to find a cure against dreaded diseases like tuberculosis and malaria, has been a showpiece of Bangalore as well as for AstraZeneca's global network of nine research centers.According to the AstraZeneca announcement, scientists will start leaving by April and the high tech research facility will close later this year. Can this advanced research center be salvaged and its high tech laboratories put to better use after the UK-based multinational AstraZeneca's disinterest in running it? The facility has a rich history and started as Astra Research Center India. It was one of the country's first corporate R&D facility in biotechnology that came up after the Indian government liberalized the rules to allow such research centers in the country in the mid-1990s. Yes. The center can easily be saved provided there is a strong will on the part of the Karnataka government to do so. BioSpectrum suggests that "Operation Salvage AstraZeneca" as a three-step process. Step 1: AstraZeneca should be persuaded to gift the facility that sits on a 14,200 square-meter plot to the Government of Karnataka as a goodwill gesture for benefiting from the presence in the state for more than two decades. Step 2: The Karnataka government should set up a separate society or a not-for-profit company and take over the facility to run it as a biotech incubation center. The research facility has advanced equipments worth more than $10 million (Rs 60 crore) at current value, which will be of immense use to start-up companies in Bangalore and elsewhere. The Indian Institute of Science (IISc), which played a key role in setting up the center in the early 1990s, could partner with the state to run it. Step 3: The Department of Biotechnology (DBT), Government of India, and other multinational companies operating in Bangalore should pitch in with funds to help run this as a national facility. Similar things have happened abroad in the recent past. AstraZeneca itself has done this in Montreal city in Quebec, Canada, in 2012. AstraZeneca closed its neuroscience research center in Montreal in February 2012 that employed 130 scientists. However, the Quebec government salvaged it by forming a cooperative venture called NeoMed Institute, supported by the state and the Canadian government. AstraZenca gifted the facility to Quebec and also provided $ 5 million. Pfizer, which has operations in Quebec, put in another $3.5 million. Furthermore, the governments and other agencies arranged over $100 million. By December 2012, the new center had started functioning as an incubator. Similarly, Merck Sharp & Dohme "gifted" its $150 million (Rs 900 crore) advanced research center near Glasgow, Scotland, when it decided to close it in February 2012. The facility was taken over by BioCity Scotland, a joint venture between BioCity Nottingham and Roslin BioCenter, both biotech incubators, under the guidance of Scottish government. Today BioCity Scotland is a thriving biopark housing dozens of biotech companies. If there is a will, there is a way, for the Karnataka government to restore a research center, which is part of Bangalore's and Karnataka's rich scientific heritage. The ball is in the court of the Karnataka chief minister Mr Siddaramaiah. ]]> <![CDATA[Drug prices being monitored: Health ministry]]> https://biospectrumindia.com/news/95/3620/drug-prices-being-monitored-health-ministry.html https://biospectrumindia.com/news/95/3620/drug-prices-being-monitored-health-ministry.html Tue, 30 Nov -001 00:00:00 +0553 The Department of Pharmaceuticals in the Ministry of Chemicals & Fertilizers has notified the Drugs (Prices Control) Order, 2013 {DPCO, 2013} on 15th May, 2013 in supersession of DPCO, 1995. There is a change in the methodology of pricing of drugs, moving from 'cost based pricing' to `market based pricing'. There are 348 medicines (652 formulations) with specified dosage and strength in the National list of Essential Medicines, 2011 (NLEM) which have been included in the first schedule of DPCO, 2013 and brought under price control. Out of total NLEM drugs, National Pharmaceutical Pricing Authority (NPPA) has already notified the ceiling process in respect of 404 formulations up to January, 2014 under the provision of the said order. In respect of drugs not covered under the Drugs (Prices Control) Order, 2013 i.e. non-scheduled drugs, manufactures fix the prices themselves without seeking the approval of Government. However, DPCO, 2013 provides for monitoring the maximum retail price (MRP) of these non-scheduled formulations that no manufacturer can increase the MRP of a non-scheduled medicine more than 10% of MRP during preceding 12 months. The Government has not studied the cost of scheduled medicines under DPCO, 2013. The government is not planning to shift the National Pharmaceutical Pricing Authority (NPPA) to the Union Health Ministry. This was stated by Mr Ghulam Nabi Azad, Union Minister for Health and Family Welfare in a written reply to the Rajya Sabha on February 11, 2014. ]]> <![CDATA[Bangladesh farmers happy with Bt brinjal experience]]> https://biospectrumindia.com/news/95/3651/bangladesh-farmers-happy-with-bt-brinjal-experience.html https://biospectrumindia.com/news/95/3651/bangladesh-farmers-happy-with-bt-brinjal-experience.html Tue, 30 Nov -001 00:00:00 +0553 "I met with eight of the 20 Bt brinjal farmers during my visits to Bangladesh in May and July," said Frank Shotkoski, director of the Agricultural Biotechnology Support Project (ABSPII) at Cornell University, which is acting as a partner with the Bangladesh Agricultural Research Institute (BARI) in developing Bt brinjal. "None of them voiced dissatisfaction with the new Bt eggplant. Each farmer assured me that they had every intention of continuing to grow the crop during the dry season when bacterial wilt is less of a problem for them." The insect resistant trait in the Bt brinjal is not designed to protect the plants against bacterial wilt infection or other agronomic challenges. Crop losses of some or all of the crop were suffered by three farmers in Gazipur, for instance, due to weather--â€?related diseases. BARI is investigating whether the Bt brinjal variety offered was appropriate for the time of planting in Gazipur when local weather conditions were extremely wet.Institutional partners involved in the Bt brinjal project today released an interactive map (http://wp.me/P4F4ac-4Q) giving full details of the field performance of South Asia's first GMO food crop during its first season in the hands of Bangladeshi farmers. Bt brinjal (locally known as "Bt begun" in the Bangla language) has been genetically engineered with a bacillus thuringensis (BT) gene enabling it to be resistant to the major pest of brinjal - fruit and shoot borer (FSB) - and therefore able to survive without major use of pesticides. Large amounts of pesticide targeted at the FSB are required for traditional brinjal cultivation in South Asia, and can have toxic effects on farmers' health and the local environment. Using on-the-ground videos, photos and interviews, the interactive map at shows that the majority of farmers' experiences of Bt brinjal were positive. Good yields were harvested, and pest- and pesticide-free labelled Bt brinjal was sold for consumption in local markets. In all cases the Bt trait was observed to confer close to 100% protection against the fruit and shoot borer (FSB) pest, and no pesticides for FSB were used by farmers growing the crop. In October 2013, the Bangladeshi government approved Bt brinjal for release. In a special ceremony in January 2014, 20 farmers from four districts -Gazipur, Jamalpur, Pabna and Rangpur - were selected to receive seedlings from Agriculture Minister Matia Chowdhury. Today's interactive map is the first comprehensive information to demonstrate the actual performance of Bt brinjal in the field from February onwards. The map was compiled via repeated field visits by staff from BARI and Cornell University. The intellectual property for the new varieties, following the donation of the new genetic material from Indian seed company Mahyco, is retained by BARI in the public sector. Farmers are encouraged to save seed, and Bt brinjal is available royalty--â€? free in perpetuity. A large number of farmers reported that they had been visited by unnamed NGO activists and journalists, who had warned them - falsely - that consuming Bt brinjal would lead to cancer, paralysis or other diseases. Bt brinjal has also been the subject of unjustified negative publicity in Bangladeshi national media. "One of the aims of the interactive map is to combat scare stories and conspiracy theories with full and transparent information about the project," said Shotkoski. ]]> <![CDATA[A bizarre fish treatment for Asthama]]> https://biospectrumindia.com/news/95/3656/a-bizarre-fish-treatment-for-asthama.html https://biospectrumindia.com/news/95/3656/a-bizarre-fish-treatment-for-asthama.html Tue, 30 Nov -001 00:00:00 +0553 Asthma patients gather every June in Hyderabad to gulp down the fish stuffed with a yellow herbal paste, in hopes it will help them breathe more easily. The wriggling five-centimeter (two-inch) fish is slipped into the throats of patient in a bizarre treatment that leaves them gagging. The Bathini Goud family, which administers the treatment, says the fish clear the throat on their way down and permanently cure asthma and other respiratory problems. However, the family refuse to disclose the ingredients of their potent formula, as they claim the disclosure will mean the mixtures loses its efficacy. Thousands of people travel from across India for the free medicine during a two-day period, the specific dates of which are determined by the onset of the monsoon every June. Rights groups and doctors have complained that the medicine is "unscientific", a violation of human rights and unhygienic, claims rejected by the family. The Indian government arranges special trains for the "fish medicine" festival every year and extra police are on duty to control crowds. After digesting the treatment, patients are advised to go on a strict diet for 45 days. ]]> <![CDATA[Cutting-Edge TB Diagnostic Test Now Available at Reduced Price ]]> https://biospectrumindia.com/news/95/3724/cutting-edge-tb-diagnostic-test-now-available-at-reduced-price-.html https://biospectrumindia.com/news/95/3724/cutting-edge-tb-diagnostic-test-now-available-at-reduced-price-.html Tue, 30 Nov -001 00:00:00 +0553 Now more tuberculosis (TB) patients can avail the benefits of one of the world's most accurate and reliable TB tests approved by WHO as private labs in the country have introduced them at a uniform reduced price. The gold standard for TB detection - the MGIT Liquid Culture will be available at a subsidized ceiling price of Rs 900 (the maximum price laboratories can charge patients) at select labs registered with Initiative for Promoting Affordable, Quality TB Tests (IPAQT), a coalition of over 60 private labs in India making WHO approved tests available at affordable prices to patients in the private sector. The cost varies between Rs 1100 - Rs 2000 in other private labs. Currently, WHO-endorsed tests are available at specially negotiated low prices only to the public sector. Liquid culture is faster, more accurate and more comprehensive than conventional solid media or sputa smear approaches. It is particularly valuable in its ability not only to detect drug resistant TB (MDR/XDR-TB) but also in determining which drugs can be used to treat patients. It is also more effective than conventional approaches in diagnosing TB in patients co-infected with TB and HIV. In India, 73 private labs (including 15 IPAQT labs) and 50 government set ups are offering the liquid culture test. Labs in IPAQT, which operates on a high-volume, low-margin model have access to lower, negotiated prices for the quality tests in exchange of their commitment to pass on the benefits to patients. "Government has taken several initiatives for controlling TB, but now the private laboratories are also coming forward and playing a critical role in TB management. The availability of low cost TB liquid culture will help improve the standard of care of TB diagnosis in low-income settings," said Prof. Rohini Kelkar, hod, Microbiology, Tata Memorial Centre, Mumbai. There are 4 tests approved by WHO: LED Microscope, Liquid Culture and two molecular tests viz. Gene Xpert and Line Probe Assay. Molecular-based tests provide rapid and accurate results and are preferred choice. However, molecular-based tests are expensive and costs around Rs. 3,500 per person. As per a report published in PLOS Medicine journal, the recently introduced Xpert MTB/RIF has limitations including limited shelf-life of the diagnostic cartridges, operating temperature and humidity restrictions, requirement for electricity supply, the need for annual servicing and calibration of each machine. The IPAQT initiative was started in March 2013 with the backing of 14 labs/hospitals and now has reached 61 labs (with over 3,000 collection centers) in Feb 2014. The members of IPAQT have tested 45000 TB suspects through one or more of the WHO approved TB tests as of March 2014. TB cases diagnosed are notified to the Revised National TB Control Programme (RNTCP) for linkages to free TB drugs, where necessary. "Use of TB liquid culture systems is the standard of care for TB diagnosis in developed countries and will revolutionize the scenario in India once adopted widely. Any private lab approved by the National Accreditation Board for Laboratories or College of American Pathologists Revised National TB Control Programme can become a member and offer the service to the public," commented Dr Shaheen Shaikh, consultant clinical microbiologist at Suburban Diagnostics, Mumbai. To promote understanding of this technology in India, private manufacturer Becton Dickinson (BD) is working with both Revised National TB Control Program and FIND (Foundation of Innovative New Diagnostics) to develop capacity for TB culture and drug susceptibility testing in 33 laboratories across India. Under the initiative, best practices are being taught using BD BACTEC MGIT liquid culture systems, quality control and quality assurance of laboratory practices. As per Dr Ranjan K Nanda, scientist, International Centre for Genetic Engineering and Biotechnology, "The culture based test will remain as a gold standard and capacity building for such tests should be given high priority in every state of our country. TB and/or HIV incidence rates could be used as an important indicator for identifying locations to facilitate culture test." ]]> <![CDATA[Glenmark's novel molecule 'GRC 27864' entering human trials]]> https://biospectrumindia.com/news/95/3750/glenmarks-novel-molecule-grc-27864-entering-human-trials.html https://biospectrumindia.com/news/95/3750/glenmarks-novel-molecule-grc-27864-entering-human-trials.html Tue, 30 Nov -001 00:00:00 +0553 Glenmark Pharmaceuticals announced that its Novel Chemical Entity (NCE) 'GRC 27864' is entering human trials. This NCE program targets Microsomal Prostaglandin E synthase-1 (mPGES-1) as a novel therapeutic target in pain management. Selective mPGES-1 inhibitors are expected to inhibit increased prostaglandin E2 (PGE2) production in the disease state without affecting other prostanoid metabolites and, consequently, may be devoid of the GI (gastrointestinal) and cardiovascular side effects seen with NSAIDs and COX-2 inhibitors, respectively. Glenmark has completed preclinical studies and Phase 1 enabling GLP studies for its selected lead molecule, GRC 27864 and has filed a Phase 1 application for first-in-human trial with the MHRA, UK. The Phase 1 studies are to be initiated soon and are likely to get completed by January 2015. Following this, Glenmark will also be initiating a proof of concept study in patients with acute pain. Dr. Michael Buschle, chief scientific officer, Glenmark Pharmaceuticals Ltd., mentioned "We are excited that our mPGES-1 discovery program is moving forward to human trials. This is another potential first-in-class molecule and there is a significant unmet medical need. This announcement also reaffirms our position globally in the development of novel pain therapies." GRC 27864 is a potent, selective, and orally bioavailable inhibitor of mPGES-1, an enzyme which is up-regulated under inflammatory conditions. Blocking the mPGES-1 enzyme is a novel strategy and expected to selectively inhibit increased PGE2 production during inflammation, without affecting other prostanoids of physiological importance. ]]> <![CDATA[Painkillers before oral surgery fail to ensure relief]]> https://biospectrumindia.com/news/95/3845/painkillers-before-oral-surgery-fail-to-ensure-relief.html https://biospectrumindia.com/news/95/3845/painkillers-before-oral-surgery-fail-to-ensure-relief.html Tue, 30 Nov -001 00:00:00 +0553 The authors hoped that by systematically reviewing existing research, they could find out whether such preemptive efforts work. Dentists often prescribe oral drugs for postoperative pain. nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen are a popular option worldwide because they are common, cheap, and effective. When painkillers are given before surgery, they ideally reduce-or even prevent-the pain that is typically felt during and after an operation. When these drugs work, patients recover faster and get back to their daily activities more quickly. The authors reviewed six quality studies of patients who had surgery for impacted wisdom teeth. These studies tested whether giving ibuprofen or another NSAID orally before the surgery could reduce the pain felt later. The studies included in the review were published between 1989 and 2012 and reported on a total of 420 patients. The authors found widely varying results among the studies. This was partly because the studies themselves were so different. Five types of painkillers were given, all at different times and in different dosages. Other factors, such as anesthesia use and evaluation methods, were also inconsistent across the group of studies. The studies reported that giving ibuprofen before or after surgery resulted in the same levels of pain, facial edema, and limited mouth opening. Ketoprofen, another NSAID, was given at different dosages before surgery in different studies, but the results were the same. According to the studies reviewed, no great improvements in pain relief were found with any other drugs given before surgery. The combined results suggested that there is no benefit from the preoperative use of ibuprofen and similar drugs in decreasing postoperative pain. The authors found it impossible to draw stronger conclusions because the timing, types of drugs and surgery, and use of other pain relief techniques varied so widely among the studies. They concluded that further careful clinical trials are required to provide solid information on this controversial topic. ]]> <![CDATA[Hospira offered USFDA approval for Dyloject Injection]]> https://biospectrumindia.com/news/95/3995/hospira-offered-usfda-approval-for-dyloject-injection.html https://biospectrumindia.com/news/95/3995/hospira-offered-usfda-approval-for-dyloject-injection.html Tue, 30 Nov -001 00:00:00 +0553 Dyloject is indicated for use in adults for the management of mild to moderate pain and for the management of moderate to severe pain alone or in combination with opioid analgesics. "In today's healthcare environment, pain management and patient satisfaction are important to hospitals. As a result, various medical organizations are now recommending a multi-modal approach to pain control in an effort to minimize the use of opioids," said Dr Sumant Ramachandra, Sr VP and CSO, Hospira. "As a leading supplier of hospital pain management medication, Hospira's Dyloject will be a complementary addition to our existing portfolio of acute-care drugs, providing clinicians an additional non-opioid option that can be administered quickly and conveniently to treat pain." As one of the most commonly used analgesics worldwide, NSAIDs also have been studied for anti-inflammatory effects. While not a replacement for opioids, Dyloject is another injectable therapy option that can be administered more conveniently in a small volume intravenous bolus over 15 seconds as opposed to other injectable non-opioid analgesics that are formulated in large volumes or require dilution prior to administration and typically require an infusion of 15 to 30 minutes to administer the full dose. ]]> <![CDATA[Eisai resurrects its shelved cancer drugs]]> https://biospectrumindia.com/news/95/4067/eisai-resurrects-its-shelved-cancer-drugs.html https://biospectrumindia.com/news/95/4067/eisai-resurrects-its-shelved-cancer-drugs.html Tue, 30 Nov -001 00:00:00 +0553 Boston Strategics in the US and Japanese company NanoCarrier each paid Eisai less than 100 million yen ($952,700) for the rights to continue development of separate cancer drugs that Eisai had put aside after the first phase of clinical trials. Boston Strategics is developing a compound for myeloid leukemia and will be paid a fee contingent upon success. NanoCarrier is using proprietary technologies to proceed with development of another cancer compound that Eisai has the rights to buy back. In both cases, Eisai has first-refusal rights to buy back the cancer drugs if further development suggests that they are marketable. It may pay the bioventures several times what they paid Eisai for the original development rights. Eisai is not alone in using this strategy to expand its lineup. Astellas Pharma has licensed a total of six compounds to four drug R&D companies in the US since 2011, with rights to buy back development and marketing rights. (News Courtesy: www.asia.nikkei.com) ]]> <![CDATA[Dr Reddy's get USFDA nod to make Valcyte]]> https://biospectrumindia.com/news/95/4318/dr-reddys-get-usfda-nod-to-make-valcyte.html https://biospectrumindia.com/news/95/4318/dr-reddys-get-usfda-nod-to-make-valcyte.html Tue, 30 Nov -001 00:00:00 +0553 Hyderabad-based Dr Reddy's Laboratories said that it has received approval from US Food and Drug Administration (FDA) to make cheaper versions of Valcyte. ]]> <![CDATA[BIRAC invites ideas for 6th BIG scheme]]> https://biospectrumindia.com/news/95/4454/birac-invites-ideas-for-6th-big-scheme.html https://biospectrumindia.com/news/95/4454/birac-invites-ideas-for-6th-big-scheme.html Tue, 30 Nov -001 00:00:00 +0553 BIG is for high level of innovation in the biotechnology sector as it does not support basic research projects. The scheme enables technology innovators and entrepreneurs to pursue a promising technology idea, and establish and validate proof of concept (POC) for the idea. The scheme supports only up-to Proof-of-Concept stage and grant-in-Aid is upto Rs 50 lakh and is 18 months mentoring support and project monitoring by BIG Partner. The proposals can be sent by start-ups or entrepreneurs having a registered company incorporated on or after January 01, 2012. Academicians, scientists, researchers, medical degree holders, biomedical engineers or graduates incubating in a Technology Business Incubator Who have innovative technology idea with considerable potential for commercialization. Only Online submission of proposal is allowed under BIG scheme. Registrations can be done on BIRAC website under â€œBIG Userâ€? for submission of proposal round the clock. It is important to note that the prior recipient of BIG grant are ineligible. Proposal Submission has already started on January, 01 and it closes on Fenruary 15, 2015. ]]> <![CDATA[Cipla announces Q3 FY14-15 financial results]]> https://biospectrumindia.com/news/95/4626/cipla-announces-q3-fy14-15-financial-results.html https://biospectrumindia.com/news/95/4626/cipla-announces-q3-fy14-15-financial-results.html Tue, 30 Nov -001 00:00:00 +0553 Key financial & performance highlights Q3 FY14-15 vis-a-vis Q3 FY13-14: (Current year figures include the relevant results of Cipla's subsidiaries from the date they became subsidiary of the company and therefore the corresponding figures for the previous period are not comparable). â€¢ Income from operations grew by 6.5% to Rs 2,765 cr, up from Rs 2,596 cr â€¢ EBITDA grew by 18.5% to Rs 554 cr, up from Rs 467 cr â€¢ Profit after tax grew by 15.3% to Rs 328 cr, up from Rs 284 cr Profit & Loss Highlights: â€¢ Material cost is at 35.8% of income from operations in Q3 FY14-15 as compared to 38.5% in Q3 FY13-14 â€¢ EBIDTA margin as % of income from operations increased by 200 bps at 20% in Q3 FY14-15 as compared to Q3 FY13-14 â€¢ Profit after tax increased by 15.3% to Rs 328 cr during Q3 FY14-15 as compared to Rs 284 cr during Q3 FY13-14 Performance Review: Domestic business: â€¢ Domestic sales grew by 14.2% to Rs 1,199 cr during Q3 FY14-15, up from Rs 1,050 cr during Q3 FY13-14 â€¢ The growth in domestic sales was largely on account of growth in Respiratory, Anti-infectives, Cardiac and Gastro Intestinal therapies International business: â€¢ Exports of formulations decreased by 6.2% to Rs 1,275 cr during Q3 FY14-15, down from Rs 1,360 cr during Q3 FY13-14. â€¢ Exports of APIs declined to Rs 151 cr during Q3 FY14-15, from Rs 158 cr during Q3 FY13-14. ]]> <![CDATA[500 nominations received for BMJ India Awards ]]> https://biospectrumindia.com/news/95/4659/500-nominations-received-for-bmj-india-awards-.html https://biospectrumindia.com/news/95/4659/500-nominations-received-for-bmj-india-awards-.html Tue, 30 Nov -001 00:00:00 +0553 The BMJ awards will be held on September 20, 2014 in New Delhi to celebrate the exceptional work being done by the healthcare community across India-right from the metros to the rural towns of the country. Ahead of that, the finalists in each category will be announced on September 05, 2014 and will do a final presentation to the jury, which will culminate in a gala awards ceremony in New Delhi. A specially convened senior judging panel will be the final arbiters of who wins a coveted trophy. Talking anout the same, Mr Anand Ekambaram, managing director, BMJ India said, "The first phase I has received an overwhelming response for the nominations. India is home to extraordinary doctors and their teams, who have made tangible contributions to improving patient care and healthcare outcomes in arduous circumstances. We have seen this in 2011, when two winners at the BMJ Awards in the UK were from India. We hope to applaud stories of determination, vision, insight, and innovation in medicine across the country and hope this initiative goes a long way in providing recognition to the real heroes of healthcare in the country." The winners will be announced at a lavish dinner before an audience of 500 of India's most senior doctors, healthcare professionals, top executives of healthcare industry, government officials, academicians, researchers and sponsors, according to the BMJ team. The BMJ's India editor, Dr Anita Jain, said "The categories reflect BMJ's values and include awards for ground-breaking research, inspirational leaders and innovations to improve patient care. Our intention is to showcase knowledge, expertise, and practices that are helping to transform healthcare throughout rural as well as urban areas. Our judges will be looking for cutting edge achievements, ways in which challenges were overcome, and impact on health outcomes, with the expectation that these will serve as inspiration to the rest of the medical community in India and across the globe." Healthcare dignitaries will present winners with a trophy and certificate, and proceedings will be overseen by a celebrity Bollywood host, whose identity is strictly under wraps until the big night. ]]> <![CDATA[Modi's Japan Visit : Stem cell research receives attention]]> https://biospectrumindia.com/news/95/4724/modis-japan-visit-stem-cell-research-receives-attention.html https://biospectrumindia.com/news/95/4724/modis-japan-visit-stem-cell-research-receives-attention.html Tue, 30 Nov -001 00:00:00 +0553 Meeting in Tokyo on 1 September 2014, Prime Minister Narendra Modi and Prime Minister Shinzo Abe pledged to realize the full potential of India - Japan Strategic and Global Partnership for continuing progress and prosperity for their people and for advancing peace, stability and prosperity in Asia and the world. Elevating the relationship to a Special Strategic and Global Partnership, they called their meeting the dawn of a new era in India - Japan relations. The two Prime Ministers noted with satisfaction the recent productive ministerial discussions in the fields of education, culture, sports, and science & technology, and recognized that the two governments can truly harness the full potential of their relationship by seizing the vast opportunities for collaborating in science & technology, innovation, education, skill development, health, and information and communications technology to create new opportunities for their talented people, transform lives and address global challenges. The two Prime Ministers decided to spur cooperation, in particular, in the cutting-edge fields such as life sciences including stem cell research, material science, cognitive science, applied mathematics, computing and information science, ocean technology and ocean observations, clean and renewable energy, water technology, climate change science and outer space. They recognized the importance to launch joint laboratories in India and Japan. They welcomed the growing collaboration between their research agencies and laboratories, and attached priority to expanding research exchanges, in particular, between their young scientists and students. The two Prime Ministers acknowledged that the richness of the relationship between the two countries came from the long-standing wealth of goodwill and warmth between their people, and expressed their determination to further enhance people to people contacts and promote mutual understanding. In this connection, they welcomed growing cooperation in tourism, youth exchanges, educational collaboration, and cultural exchanges including the cultural activities which will be held under the Festival of India in Japan. Prime Minister Abe expressed his appreciation for Prime Minister Modi's Digital India initiative. The two Prime Ministers affirmed the importance of collaboration in the field of information and communications technology (ICT) through ICT Comprehensive Cooperation Framework. Prime Minister Abe invited India to participate in the 'Sport for Tomorrow' programme. Prime Minister Modi welcomed this proposal. The two Prime Ministers expressed satisfaction at the growing educational and research partnership, including in humanities and social sciences - from the revival of Nalanda University, the ancient seat of learning, to addressing tomorrow`s challenges through the establishment of Indian Institute of Technology, Hyderabad (IIT-H), and the Indian Institute of Informational Technology, Design and Manufacturing in Jabalpur (IIITDM-J), cutting-edge institutions of the 21st century. They decided to make efforts to substantially increase the number of exchange students between India and Japan as well as to enhance Japanese language education in India. The two prime Ministers welcomed the launch of cooperation in the field of healthcare. They appreciated the growing cooperation in the field of women empowerment. Prime Minister Abe briefed Prime Minister Modi on his efforts to create a 'society in which all women shine'. Sharing the view of Prime Minister Abe, Prime Minister Modi stressed the need to recognise the power of women and their important role in nation-building and the development journey of a country. ]]> <![CDATA[Ranbaxy raises awareness on heart diseases]]> https://biospectrumindia.com/news/95/5042/ranbaxy-raises-awareness-on-heart-diseases.html https://biospectrumindia.com/news/95/5042/ranbaxy-raises-awareness-on-heart-diseases.html Tue, 30 Nov -001 00:00:00 +0553 Ranbaxy Laboratories and APICON 2015 (70th Annual Conference of Association of Physicians of India) broke the Guinness World Record for making the largest human image of a heart in India. Realizing the need for a proactive emphasis on preventive healthcare and raising awareness about heart disease in India, Ranbaxy & APICON assembled 982 people (consisting of doctors and Ranbaxy employees) to form a human heart. On this occasion, Mr. Rajeev Sibal, VP and head-India region, Ranbaxy, said, "It gives me immense pleasure to witness the successful conclusion of the Guinness World Record attempt by Ranbaxy and APICON. The event would be truly successful when each one of us daily take the 30 minutes exercise challenge and spread the message to more and more number of people. Ranbaxy will always continue its endeavour to spread the importance of exercise and fitness to larger masses and motivate people to lead a healthier life." The formation of the human heart was achieved in 1 hour and 15 minutes. The creation beat the world record for the largest image of a human organ ever formed by a group of humans assembled together. The earlier record was set on February 20, 2014, in Liverpool, UK, when 687 people came together to form the image of the largest human brain on World Encephalitis Day. Indians have genetic predisposition to the Coronary Artery Disease (CAD). Changing lifestyle, urbanization, unhealthy food habits, decreasing physical activity, rising stress levels and rampant obesity have made the problem more severe. As a result, the country has seen a significant increase in the number of heart disease patients over the past 20 years. Worse, the average age of a heart patient in India is in the early fifties, compared to seventies in developed nations like the US. ]]> <![CDATA[AIIMS appointment gets simpler: Now dial a no. from anywhere, anytime]]> https://biospectrumindia.com/news/95/5063/aiims-appointment-gets-simpler-now-dial-a-no-from-anywhere-anytime.html https://biospectrumindia.com/news/95/5063/aiims-appointment-gets-simpler-now-dial-a-no-from-anywhere-anytime.html Tue, 30 Nov -001 00:00:00 +0553 Hopefully the long qeues in front and outside the AIIMS will soon be the thing of the past. Dr Jitendra Singh, union minister of state for science and technology on September 04, 2014, launched the "Appointment From Home" facility at the institue, the first ever facility of its kind to be started in a government sector hospital in India wherein patients will have the option of dialing Phone No. 09266092660 from anywhere in the country. The facility will connect them to "Interactive Voice Response" (IVR) service following which a pre-recorded voice will ask them about the OPD Department where the appointment is sought and also give the option of different available dates. Speaking on the occasion, Dr Jitendra Singh said that there has been a revolutionary progress in Information Technology in the last two decades and in the interest of better patient care, it should be utilized to its optimum potential in the hospital set up. He recalled the days at the AIIMS when for the afternoon super-specialty OPD, patients had to physically line up in a queue from 10 o'clock in the morning and after procuring OPD cards, they had to again wait outside doctors` chambers and finally by the time they would go home after the consultation, it would get late evening thus consuming an entire one man-day of work. Dr Jitendra Singh said, with the patient load in the Government sector hospitals increasing at a hectic pace and the Resident Doctors as well as Para-Medical and Nursing Staff under tremendous pressure, the use of e-technology in healthcare will help to save lot of time and energy, which can instead be devoted to patient care. Dr Jitendra Singh said, Science and Technology Ministry, headed by him, will provide all the necessary support to carry forward the process of e-health care and added that in near future, the AIIMS will also have the provision for online counseling for aspirants to MBBS, MD, DM Exams as well as online entrance examination facility. On the occasion, Director AIIMS Prof. Dr. M.C. Mishra felicitated Dr Jitendra Singh for his extraordinarily encouraging patronage which he said would help in modernizing the various facilities at AIIMS. Also present on the occasion were Mission Director e-Governance at AIIMS Dr. Gailora, Medical Superintendent Dr. D.K. Sharma, Dr. Sanjiv Bhoi, Joint Secretary, Health Sandeep Naik and Dr. Deepak Agarwal. ]]> <![CDATA[Sri Krishna Pharma charged with data manipulation and GMP deviation]]> https://biospectrumindia.com/news/95/5099/sri-krishna-pharma-charged-with-data-manipulation-and-gmp-deviation.html https://biospectrumindia.com/news/95/5099/sri-krishna-pharma-charged-with-data-manipulation-and-gmp-deviation.html Tue, 30 Nov -001 00:00:00 +0553 Canadian importers have unanimously agreed to quarantine products made with active pharmaceutical ingredients (APIs) from Hyderabad-based drugmaker Sri Krishna Pharmaceuticals, due to data integrity concerns. Also, the Italian Medicines Agency has withdrawn the Good Manufacturing Practice (GMP) certificate of the company, owing to about 10 GMP deviations found during an inspection in December 2014. ]]> <![CDATA[GSK moves to new smart office in Gurgaon]]> https://biospectrumindia.com/news/95/5106/gsk-moves-to-new-smart-office-in-gurgaon.html https://biospectrumindia.com/news/95/5106/gsk-moves-to-new-smart-office-in-gurgaon.html Tue, 30 Nov -001 00:00:00 +0553 The design has been inspired by the GSK 'heart' which forms the core of the GSK logo and encapsulates the company's dedication to improve the quality of lives by do more, feel better and live longer. Commenting on the move to the new office, Mr Zubair Ahmed, MD, GlaxoSmithKline Consumer Healthcare, said, "We are excited and looking forward to an open, free and fun work environment, allowing employees to enjoy their work and be more productive. The idea of this smart office originated from an internal study which indicated that 85% of the assets in any office were dedicated to stationed cubicles. Interestingly only 35% of work related activities were happening in these areas. This is a dramatic shift from the usual office set-up to an absolute barrier free, flexi seating options across levels." The smart office with its formal and informal spaces has been tech'ed up to ensure that work continues uninterrupted from any corner. The design comprises flexible seating and cabin less format that would encourage greater collaboration and strengthen engagement. Employees are empowered to select their own seats within their functional neighbourhood and outside of that. In a complete shift from the past, the functional heads now share space with their respective teams to drive greater teamwork. This is the second smart office from the ground-up within GSK after the North American Headquarters at Navy Yard, Philadelphia. The design of the space is inspired by the human body: the heart, the vein, the brain and the skin. At the core of the office is the 'heart' which drives the energy from the lift lobby and the open greeting area of the reception. The vein outlines this section, creating the central circulation through the access controlled spaces for movement and connectivity that inspires conversations. The third layer is the brain - the space where ideas take birth in smart working meeting rooms, quiet rooms and small relaxed huddle areas. The final area is the skin - the space where work breathes and gives rise to collaboration and co-creation. ]]> <![CDATA[Civil society asks govt to treat acute malnutition as medical emergency]]> https://biospectrumindia.com/news/95/5143/civil-society-asks-govt-to-treat-acute-malnutition-as-medical-emergency.html https://biospectrumindia.com/news/95/5143/civil-society-asks-govt-to-treat-acute-malnutition-as-medical-emergency.html Tue, 30 Nov -001 00:00:00 +0553 It is a bitter truth that despite a rapidly growing economy, every year close to 1 million children die from severe acute malnutrition in India. This means nearly one child death every thirty seconds. These children suffer from extreme hunger; they have low weight and swelling. Yet this disease is entirely treatable and preventable- children who cannot eat normal food anymore need specific treatment. Keeping this in view, ACF-India (Action Contre La Faim-Action Against Hunger) and Fight Hunger Foundation, on January 20, 2015, launched the "Generation Nutrition Campaign" with a vision to end child deaths from acute malnutrition in India. The launch was marked by an event, "Acute Malnutrition - An Everyday Emergency", inaugurated by Mr Sudarshan Bhagat, union minister of state for rural development. At the event, ACF-India, also, launched the "Acute Malnutrition: An Everyday Emergency" reports from Burhanpur District, Madhya Pradesh and Baran District, Rajasthan. These reports throw light on the malnutrition situation in the two districts analyzing the infant mortality rates and child deaths due to conditions which are preventable. In his keynote address, Mr Sudarshan Bhagat, mentioned, "Malnutrition is a big challenge for the entire global community. In India, 42 percent children are underweight in proportion to their age and 52 percent children look younger than their actual age. The Government of India is taking these issues very seriously. Nutrition and education are the birth rights of every child in India. Government is currently implementing several initiatives and programs to address the problems of hunger and malnutrition at district and block levels. As reiterated by the Prime Minister of India on several occasions, our national mission or 'Abhiyan' is to build a modern India where poverty and malnutrition are eradicated. I intend to take the outcomes of this conference directly to the Prime Minister and other authorities". The campaign urges the government to recognize Severe Acute Malnutrition as a medical emergency and take urgent preventive action to avert India's nutrition crisis. Senior members of ACF-India, Fight Hunger Foundation and prominent partner organizations - MSF-India, Water Aid-India, Sphere-India, World Vision-India, Rotary International, The Coalition for Food and Nutrition Security appealed for action to the minister, urging the government of India to recognize severe acute malnutrition as a medical emergency; improve and scale up detection and management of severe acute malnutrition; allow adapted treatment at community level; improve governance and nutrition surveillance and commit and plan to reduce acute malnutrition. Dr Rajiv Tandon, deputy country director, ACF-India, said, "At the onset, we are extremely honored to see the initiatives taken by Narendra Modi, Prime Minister of India, in the areas of development, governance and social sector reforms. Severe Acute malnutrition is a medical emergency today with an alarming about 80 lakh children in India suffering from it. We appeal to the Prime Minister and the Finance Minister to take urgent action to address the issue of Severe Acute malnutrition to ensure that these children who are mostly in rural and tribal areas of India survive and thrive. We request the government to ensure adequate budget allocations, appropriate policies, convergent action at block level for implementing quality programs equitably. This will help in improving the social infrastructure and human capital in India". Mr Thomas Gonnet, executive director, ACF-India, set an urgent context for the issue of malnutrition in India: "India is one of the top five high burden countries for acute malnutrition. I believe that a collaborative approach involving governments, civil society organizations such as ACF, the Fight Hunger Foundation and others, and the international communities will be a strong force to make the world free of child deaths from acute malnutrition within a generation. Everyone can engage in the campaign, by signing the petition to call world leaders to set up international targets for reduction of acute malnutrition. Find out more at generation-nutrition.org". ]]> <![CDATA[Strides Arcolab reports Q3 FY 2014-15 results]]> https://biospectrumindia.com/news/95/5151/strides-arcolab-reports-q3-fy-2014-15-results.html https://biospectrumindia.com/news/95/5151/strides-arcolab-reports-q3-fy-2014-15-results.html Tue, 30 Nov -001 00:00:00 +0553 Commenting on the results, Mr Arun Kumar, founder and group CEO of Arcolab's stated "We had a steady quarter across our businesses with strong US filings of our niche products. We are particularly delighted with the ramp-up of Anti-Malarial business and our recent partnerships with Gilead." Corporate Updatesâ€¢ Scheme of Amalgamation with Shasun Pharmaceuticals Ltd.o Received No Objection from NSE and BSEo CCI and FIPB approvals awaitedo Application filed with the Hon'ble High Courts of Bombay and Madras seeking directions to convene a Shareholders' meetingâ€¢ Singapore's Economic Development Board grants International Headquarter Status to Strides Pharma Global Pte. Ltd., Singapore Performance Highlights â€¢ Adjusting for one time revenues in Oct-Dec FY13-14, Q3 FY15 Revenues grew by 19%â€¢ Revenue growth driven by: o First full quarter of Raricap in our Brands India businesso Commencement of Anti-Malarial supplies â€¢ Q3 FY15 EBITDA grew by 10% to INR 664 Mn against INR 605 Mn in Oct-Dec FY13-14 o Increase in R&D spend with 4 US filings during the quartero Significantly lower Profit Share recognized on Vancomycin, pending reconciliation of chargebacks and other costs with the partnerâ€¢ YTD Dec FY15 Revenues grew by 10% and EBITDA grew by 32% Pharma R&D and Regulatory Updateâ€¢ Continued US FDA approval status for Oral Dosage Facility at Bangaloreâ€¢ 4 Product Filings with USFDA during Q3 FY15â€¢ Received USFDA Product approval for Calcitriol Softgel Capsules (Market Value ~USD 50 Mn)â€¢ Continued niche product approvals in Europeâ€¢ Net R&D spend at INR 109 Mn during Q3 FY15, against INR 57 Mn in Q2 FY15â€¢ Net R&D spend at INR 204 Mn during YTD Dec FY15, against INR 120 Mn in Apr-Dec FY13-14 Biotech â€¢ Net R&D Spend for Q3 FY15 at INR 10 Mn and at INR 53 Mn during YTD Dec FY15â€¢ Commenced construction of Multi Product Biologics facility at Bioxcell Biotechnology Park, Johor, Malaysiaâ€¢ Revenue Composition by Business - Global Pharma Regulated Marketsâ€¢ Revenues at INR 966 Mn in Q3 FY15, representing 30% of the total revenuesâ€¢ Revenues decreased to INR 966 Mn against INR 1,093 Mn in Q2 FY15, on account of lower profit share recognized during the quarterâ€¢ Successfully launched 2 new products in the US - Buspirone Hydrochloride Tablets and Tacrolimus Capsules Institutional Businessâ€¢ Revenues at INR 1,284 Mn in Q3 FY15, representing 39% of the total revenuesâ€¢ Revenues increased by 58% to INR 1,284 Mn against INR 813 Mn in Q2 FY15, driven by Anti-Malarial supplies in the quarterâ€¢ Collaboration with Medicines for Malaria Venture (MMV) for the development of rectal artesunate for pre-referral treatment of children with severe malariaâ€¢ Partnership with Gilead Sciences Inc. to manufacture and distribute Tenofovir Alafenamide (TAF) based HIV treatments in 112 developing countriesâ€¢ Licensing Agreement of Hepatitis C with Gilead expanded to include Investigational Pan-Genotypic Agent Emerging Marketsâ€¢ Revenues at INR 1,011 Mn in Q3 FY15, representing 31% of the total revenuesâ€¢ Revenues steady at INR 1,011 Mn against INR 1,022 Mn in Q2 FY15â€¢ Successful integration of the Raricap business enabling pan India presence ]]> <![CDATA[Health ministry launches 'Phool Khil Jayenge,' a song celebrating child health and immunization]]> https://biospectrumindia.com/news/95/5253/health-ministry-launches-phool-khil-jayenge-a-song-celebrating-child-health-and-immunization.html https://biospectrumindia.com/news/95/5253/health-ministry-launches-phool-khil-jayenge-a-song-celebrating-child-health-and-immunization.html Tue, 30 Nov -001 00:00:00 +0553 A public service message in the form of a music video 'Phool Khil Jayenge' was launched by minster of health and family welfare Dr Harsh Vardhan. Also present were renowned lyricist and Member of Parliament Javed Akhtar, actor Shabana Azmi, singer Sonu Nigam, and music director Lalit Pandit. The song highlights the importance of immunization in saving lives of Indian children, given that 14 lakh children under 5 years of age die every year in India due to preventable diseases, like pneumonia and diarrhea. Just last month, the Prime Minister's Office announced the introduction of four new vaccines: rotavirus, rubella, polio (injectable), and an adult vaccine for Japanese Encephalitis in districts with high The lyrics of the song have been written by well-known poet, scriptwriter and Rajya Sabha MP Javed Akhtar,and Bollywood actors Farhan Akhtar and Vidya Balan feature in the video. Prominent singers Sonu Nigam and Alka Yagnik sang the song and music director Lalit Pandit composed the music. The minister also highlighted that his ministry is committed to tackling child mortality and ensuring that the benefits of immunization reach all sections of society, regardless of social and economic status. A panel discussion titled 'The Right of Every Child to Survive and Thrive,' set the tone for the evening, moderated by Bachi Karkaria. The panelists included Health Minister, Dr. Harsh Vardhan, the Health Secretary, Mr Lov Verma, the Additional Secretary from the Ministry of Health, Mr CK Misra, Mr Javed Akhtar, Mr Sonu Nigam and Mr Lalit Pandit. The panel lauded the Government's initiative for expanding the Universal Immunization Programme and providing free vaccines against 13 life threatening diseases to 27 million children annually. Member of Parliament and lyricist, Javed Akhtar said: "It's an honour to be a part of an initiative to raise awareness about the importance of immunization. We wanted to convey this message through simple and effective lyrics and we hope we have been able to achieve that. It is my sincere hope that we don't lose young lives to diseases for which vaccines exist and that all children in India have access to immunization." Actor Farhan Akhtar said from Mumbai, â€œAs the father of two young daughters, I relate to the need to protect children from life-threatening and preventable diseases. I believe parents who do not immunize their children do them a great disservice and risk their lives. I am very happy to have been part of this endeavor to raise awareness about the need to immunize every child in this country.â€? Bollywood singer Sonu Nigam added, â€œI believe that as role models we play an important role in spreading these messages, and what better way than to participate in this campaign. Every child has the right to good health, and one of the easiest ways to ensure this is through immunization. I therefore appeal to all parents to get their children immunized without fail.â€? Currently, more children die in India each year than in any other country. Annually, more than 14 lakh children under five die in India. Once children survive the first month, infectious diseases are the biggest threats to their survival despite being preventable. Diarrhea and pneumonia account for more than 4,36,000 deaths among Indian children aged 1-59 months of age. ]]> <![CDATA[NIV showcases its key diagnostic kits on Nadda's visit]]> https://biospectrumindia.com/news/95/5798/niv-showcases-its-key-diagnostic-kits-on-naddas-visit.html https://biospectrumindia.com/news/95/5798/niv-showcases-its-key-diagnostic-kits-on-naddas-visit.html Tue, 30 Nov -001 00:00:00 +0553 On February 14, 2015, the health and family welfare minister, Mr Jagat Prakash Nadda visited the institute. Dr D T Mourya, director, National Institute of Virology welcomed him and accompanied him to Biosafety level-4 laboratory. Dr Mourya briefed him about vision, mission and mandate of the institute. He also explained how the institute has been serving nation for benefit of human health by working on water borne infections, zoonotic diseases, arboviral diseases, highly infectious diseases of emerging and reemerging nature for 64 years. Minister was also briefed that NIV, Pune is a premier institute of ICMR and also provides integral support in national and international emergency for viral diseases like Ebola, Crimean Congo hemorrhagic fever, Nipah, MERS-corona virus, pandemic and avian influenza, and many more viral diseases. Recently, institute has developed many important technologies of public health importance. Tissue culture derived vaccine against Japanese encephalitis has been launched by India as first indigenously developed vaccine of country. The institute has also developed ELISA kits for detection of IgG antibody against CCHFV bovine and Sheep and Goat IgG antibody detection, CCHFV Human IgG antibody detection ELISA, KFD Human IgM antibody detection ELISA, Immunodiagnostic development for HEV, Chandipura virus IgM ELISA and also detection of JE virus from mosquito using monoclonal antibody based antigen capture ELISA. The minister was informed that these technologies are ready to transfer to industry. NIV has three units located at Gorakhpur, Kerala and Bangalore. The unit at Bangalore has a polio-monitoring center. Being a premier institute, it is involved in providing diagnostic kits for whole country to diagnose JE, WN, dengue and chikungunya viral diseases surveillance program. ]]> <![CDATA[Intas launches biosimilar 'Razumab' for treating eye degeneration]]> https://biospectrumindia.com/news/95/6267/intas-launches-biosimilar-razumab-for-treating-eye-degeneration.html https://biospectrumindia.com/news/95/6267/intas-launches-biosimilar-razumab-for-treating-eye-degeneration.html Tue, 30 Nov -001 00:00:00 +0553 Intas Pharmaceuticals has launched RAZUMABTM, its biosimilar to Lucentis® (ranibizumab). Intas is the first company globally, to develop and launch a biosimilar version of ranibizumab. RAZUMABTMis manufactured under strict guidelines for sterile use in the eye and is offered as single dose vial, thus reducing the risk of contamination during use. Ranibizumab is a therapeutic antibody fragment designed specifically for treating degenerative conditions of the eye. It blocks the production of vascular endothelial cell growth factor A (VEGF-A), a protein which when overexpressed leads to abnormal blood vessel growth in the retina, that can cause leaks and vision loss. Ranibizumab is indicated for the treatment of Neovascular (Wet) Age-related Macular Degeneration (AMD), a common degenerative condition of the eyes in the elderly. It is also indicated for Macular Edema following Retinal Vein Occlusion (RVO), Diabetic Macular Edema (DME), Diabetic Retinopathy in patients with Diabetic Macular Edema and vision loss resulting from choroidal neovascularization in pathologic myopia (mCNV). With the mission to provide global healthcare at affordable costs, RAZUMABTM will be about 25 percent cheaper than the imported Lucentis® in the hand of the patient. This would lead to an annual saving of about Rs 35,000 or more in the cost of treatment to the patient, depending on the number of injections used and the clinical condition of the patient. Our objective is to make the treatment available to a wider patient pool, that is as yet denied treatment due to high cost of imported Lucentis®" said Mr Binish Chudgar, the vice chairman of the company. RAZUMABTM is the tenth biosimilar launched by Intas in India, by far the largest number of indigenously developed biosimilars by any company. Since 2004, when Intas launched its first biosimilar, Intas has constantly worked to bring the latest in biological therapies to Indian patients at affordable prices. With its robust pipeline of future products under development, Intas aims to continue on this endeavor. Till date, Intas is also the only company from India to have launched a biosimilar in the highly regulated European market and is also the only company from India to have two of its biosimilars filed for registration in the US. Its first biosimilar for global markets, Accofil (filgratsim) was launched in Europe earlier this year. The company expects to launch its first biosimilar in the US within the next 9 - 12 months. Intas' manufacturing facilities are approved by global regulatory agencies such as EMA, ANVISA, WHO and others. RAZUMABTM is also manufactured in the same facilities as its other biosimilars. ]]> <![CDATA[Progress being made in malaria control globally: WHO]]> https://biospectrumindia.com/news/95/6372/progress-being-made-in-malaria-control-globally-who.html https://biospectrumindia.com/news/95/6372/progress-being-made-in-malaria-control-globally-who.html Tue, 30 Nov -001 00:00:00 +0553 Every year vaccination averts 2 to 3 million infant deaths globally from deadly diseases such as diphtheria, hepatitis B, measles, mumps, pertussis, polio and tetanus. Vaccines save lives, but 1 in 5 children, an estimated 21.8 million infants worldwide still miss out on basic vaccines. Of them, 9 million infants, more than one-third, live in WHO's South-East Asia Region. Of the 40 million children born in the South-East Asia region every year, only about 75 percent get all three doses of diphtheria-pertussis-tetanus vaccines. "Children miss out on measles vaccines. In 2013 about 26 percent of the global measles deaths, almost 38,000 occurred in countries in the South-East Asia region, 27,500 in India alone," revealed Dr Poonam Khetrapal Singh, regional director, WHO South-East Asia. These grim statistics underscore the need to intensify efforts to protect children with lifesaving vaccines. "We must close these immunization gaps. We must emulate lessons learnt from major public health wins, especially the polio eradication programme, to reach the unreached - the underserved children living in remote areas and in deprived urban and other settings - to ensure equity with routine immunization vaccines," she added. "To increase and sustain vaccination coverage, we need to strengthen health systems and link vaccine delivery to other health interventions," Dr Poonam said. Addressing the resource crunch, competing health priorities, poor management of health systems, inadequate monitoring and supervision and low awareness level among parents is critical to making vaccination available to all children. Vaccination is a known cost-effective health intervention. "Increasing vaccination coverage will accelerate control of vaccine preventable diseases and reduce death and diseases among children," voiced Dr Poonam. She continued, "Vaccination is also a shared responsibility. Collective efforts are needed by government, partner agencies, health professionals, academia, civil society, media, private sector and the community itself. And all of the above should be steered by continued strong political commitment and backed with resources." With concerted efforts, WHO South-East Asia aims at maternal and neonatal tetanus elimination this year, measles elimination and rubella and congenital rubella syndrome (CRS) control by 2020; sustaining the victory over polio until the disease is eradicated globally; increasing immunization coverage to >90 percent at the national level and to >80 percent at the district level with the three doses of diphtheria-pertussis-tetanus vaccines. WHO believes that every child has the right to lead a healthy life, and vaccination is a vital step. The World Immunization Week this year focuses on closing the immunization gap and reaching equity in immunization levels with renewed efforts. ]]> <![CDATA[UP Governor visits Lucknow Biotech Park ]]> https://biospectrumindia.com/news/95/6510/up-governor-visits-lucknow-biotech-park-.html https://biospectrumindia.com/news/95/6510/up-governor-visits-lucknow-biotech-park-.html Tue, 30 Nov -001 00:00:00 +0553 With an objective to popularize the benefits of scientific knowledge and practical appropriation,Lucknow Biotech Park celebrated National Science Day in collaboration with Indian National Science Academy on 28th February, 2015. Mr Ram Naik, the Governor of UP who was the Chief Guest visited Biotech Park facilities and congratulated Biotech Park for organizing the scientific activities on the National Science Day and he assured galaxy of scientists that the seeds sown by Ex- Prime Minister Atal Bihari Bajpaye by way of conceiving and laying foundation stone of Biotech Park, will be promoted to lead science and translation of technologies in the country particularly U.P. Mr Naik besides visiting the facilities at Campus also checked the recently set up lab infrastructure at the Life Care Innovations, an innovative company set up by Dr J N Verma. Dr Verma thanked the Governor and expressed his happiness for visit and encouragement. Mr Naik furter mentioned that biotech Park can play an important role in the development of the state and its activities and should be further expanded to serve as National Biotechnology Translational Research Institute. He assured that his will support the proposed National Biotechnology Translational Research Institute at the Biotech Park as national hub of Biotechnology. Earlier welcoming him, Dr P K Seth, CEO, Biotech Park said that Park is quietly moving from strength to strength. Today it is a meeting point of industry, research institutes and the academia. The creation of Park changed the landscape of the state and brought biotechnology related industry in the State. Park is a happening address and home for more than 20 new companies. The Park has brought culture of tissue culture in State as when you travel from Sitapur Road you see on both sides of the road or railway track banana plantation as if you are traveling in Bhusawal. While Park is providing facilities for High tech research in area og health and energy, it is meeting the needs of the farmers and helping them to increase their yield and benefit economically. ]]>